MannKind Corp (MNKD) 2024 Q3 法說會逐字稿

Good afternoon, and welcome to the MannKind Corporation third quarter 2024 financial results earnings call. As a reminder, this call is being recorded on November 7, 2024, and will be available on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days.

下午好，歡迎參加 MannKind Corporation 2024 年第三季財務業績收益電話會議。提醒一下，本次電話會議將於 2024 年 11 月 7 日錄製，並將在本次電話會議結束後不久在 MannKind Corporation 網站上提供，並提供約 90 天。

This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, which can cause actual risks to differ materially from those stated expectations. For further information on the company's risk factors, please see the 10-Q report filed with the Securities and Exchange Commission this morning, 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所述的預期有重大差異。有關公司風險因素的更多信息，請參閱今天上午向美國證券交易委員會提交的 10-Q 報告、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. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

今天與我們一起參加活動的有 MannKind 的執行長 Michael Castagna；和財務長克里斯·普倫蒂斯（Chris Prentiss）。現在我想將會議交給卡斯塔尼亞先生。先生，請繼續。

Thank you, operator, and to our entire MannKind team for all the accomplishments we've had this quarter. I've never been more excited and energized about our opportunities to grow MannKind over the coming years. Today, I'll open up with operational and pipeline highlights, followed by Chris giving a financial overview with closing remarks going to Q&A.

謝謝營運商，也感謝我們整個 MannKind 團隊在本季取得的所有成就。對於未來幾年發展 MannKind 的機會，我從未感到如此興奮和充滿活力。今天，我將首先介紹營運和通路亮點，然後由克里斯介紹財務概況，最後進行問答。

As we look at our third quarter highlights, Tyvaso DPI collaboration continues to show record-setting revenue and expansion opportunities as we look at our manufacturing revenue and continued opportunities with Tyvaso in IPF. We're super excited by the continued strong collaboration with United Therapeutics. And now as we start to migrate from just the Tyvaso DPI and Afrezza, the pipeline is emerging as one of our focuses this year, and we're excited by the readouts in nintedanib Phase 1. We just completed the Phase 1 that we announced this week as well as our clofazimine inhalation study that is well under its way, with Phase 3 site activations where we have ongoing opportunities here in the US as well as Asia, as we're starting that trial.

回顧第三季的亮點，我們發現 Tyvaso DPI 合作繼續展現出創紀錄的收入和擴張機會，而我們回顧製造收入以及與 Tyvaso 在 IPF 領域的持續合作機會。我們對與 United Therapeutics 的持續密切合作感到非常興奮。現在，當我們開始從 Tyvaso DPI 和 Afrezza 遷移時，該管道正成為我們今年的重點之一，我們對尼達尼布第 1 階段的讀數感到興奮。我們剛剛完成了本周宣布的第一階段研究以及正在順利進行的氯法齊明吸入研究，第三階段的試驗地點已啟動，我們在美國和亞洲都有持續的試驗機會，我們正在開始這項試驗。

The EBU net revenue for the quarter was $20 million or 10% versus last year, and we saw Afrezza overall for the year slightly impacted by headwinds throughout the first three quarters as we focused on profitable growth by realigning our sales force back in Q1. As we look at Q4, we're looking to accelerate our growth in Afrezza in 2025 and the early indicator here are some of the changes we made that I'll talk about here, where we have 8% growth in NRxs year-over-year.

EBU 本季的淨收入為 2,000 萬美元，較去年同期成長 10%，我們發現 Afrezza 全年總體上受到前三個季度不利因素的輕微影響，因為我們在第一季度透過重新調整銷售團隊專注於獲利成長。展望第四季度，我們希望在 2025 年加速 Afrezza 的成長，這裡的早期指標是我們所做的一些改變，我將在這裡討論，其中 NRxs 同比增長 8%。

Our pediatric study will be reading out very shortly here at the end of Q4. And we have a strong financial position with $268 million in cash, with $15 million in non-GAAP operating income for the quarter. We're leaving here in Q3 in a very strong financial position as we get ready to fund our innovation here with clofazimine-101 and 201 moving forward.

我們的兒科研究結果將在第四季末很快公佈。我們的財務狀況強勁，擁有 2.68 億美元現金，本季非 GAAP 營業收入為 1,500 萬美元。在第三季度，我們將保持非常強勁的財務狀況，因為我們準備為氯法齊明-101 和 201 的創新提供資金。

Now let me bridge over to clofazimine-101. As we look at the clinical development program, there's a significant unmet need in NTM lung disease due to current options having very severe limitations on both efficacy, safety and tolerability.

現在讓我轉到氯法齊明-101。當我們審視臨床開發計劃時，我們發現，由於目前的治療選擇在療效、安全性和耐受性方面都存在非常嚴重的限制，因此在 NTM 肺病治療方面存在大量未滿足的需求。

We believe oral clofazimine has been part of the guidelines since 2020 and, by developing an inhalation suspension, we have a great opportunity to put more drug into the lung really at the site of infection while minimizing the systemic exposure, which is really important as we think about the clofazimine-related side effects of skin discoloration, QT prolongation and drug accumulation in the organs. We also believe our convenient dosing cycle of 28 days on, and 56 days off will provide us a competitive advantage.

我們相信口服氯法齊明自 2020 年以來就已成為指南的一部分，透過開發吸入懸浮液，我們有很好的機會將更多的藥物真正注入感染部位的肺部，同時最大限度地減少全身暴露，這一點非常重要，因為我們考慮到與氯法齊明相關的皮膚變色、QT 延長和器官中藥物蓄積的副作用。我們也相信，28天服藥、56天停藥的便利給藥週期將為我們提供競爭優勢。

Unfortunately, as we look out in the space, MannKind is one of the last remaining companies, outside of Insmed, investing in NTM at this point due to the failures of several competitors this past year. I want to remind you of the ICoN-1 Phase 3 study design, where we now have about 25% of sites activated. And when you think about this trial, we're aiming for about 180 patients, primary endpoint at six months, and we'll start with 28 days of treatment, we'll be off for 56 days of treatment and then 28 days on and 56 days off.

不幸的是，放眼整個領域，由於去年幾家競爭對手的失敗，MannKind 是 Insmed 之外最後幾家在 NTM 領域進行投資的公司之一。我想提醒您 ICoN-1 第 3 階段研究設計，其中我們現在已經有大約 25% 的網站被啟動。當您想到這項試驗時，我們的目標是大約 180 名患者，主要終點為六個月，我們將從 28 天的治療開始，然後停藥 56 天，然後開始 28 天治療，再停藥 56 天。

After that second treatment cycle will be our primary endpoint, and we are going with a single dose suspension of 80 milligrams inhaled and a 2:1 randomization. We'll have an interim analysis after the first 100 patients and that'll look to make sure that the trial is on track to achieve its endpoint or if we have to make any adjustments based on the statistical plan that's been pre-identified.

第二個治療週期之後將是我們的主要終點，我們將採用 80 毫克吸入單劑量懸浮液並進行 2:1 隨機化。我們將在前 100 名患者之後進行中期分析，以確保試驗能夠按計劃實現其終點，或者我們是否需要根據預先確定的統計計劃做出任何調整。

I want to remind you the co-primary endpoint of sputum conversion and patient reported outcomes for the US, and the rest of the world is just sputum conversion. We will conduct one trial with both endpoints for the various countries in the US as well as the rest of world. We are in Asia right now activating sites as well as having a kickoff meeting for investigators. I want to thank the team for all the hard work over there. We do have FDA Fast Track QIDP in orphan, which provides us with 12 years of exclusivity as we get off the ground.

我想提醒您，美國和世界其他地區的痰液轉化和患者報告結果的共同主要終點只是痰液轉化。我們將對美國各國以及世界其他地區進行一次雙終點試驗。我們現在正在亞洲啟動站點並為調查人員召開啟動會議。我要感謝團隊在那裡所做的一切努力。我們確實擁有孤兒藥領域的 FDA 快速通道 QIDP，這為我們起步時提供了 12 年的獨佔權。

Now bridging to nintedanib DPI. This is an exciting opportunity for the company. When we think back, I want to remind you that Technosphere technology is mostly made up of FTKP plus our Dreamboat device. And the reason I bring this up is it's a platform technology where we really know where the product flows. And you can go back to some of our earlier studies on radio labeled Technosphere insulin insulation powder, where 90% of the powder is FTKP and about 10% is insulin, and we really see wide distribution across the lungs in the upper and lower lobes.

現在正在橋接尼達尼布 DPI。這對公司來說是一個令人興奮的機會。當我們回想起來時，我想提醒你，Technosphere 技術主要由 FTKP 加上我們的 Dreamboat 設備組成。我之所以提起這一點，是因為它是一種平台技術，我們真正知道產品流向何處。您可以回顧我們早期對無線電標記的 Technosphere 胰島素絕緣粉的一些研究，其中 90% 的粉末是 FTKP，約 10% 是胰島素，我們確實看到它廣泛分佈於肺部的上葉和下葉。

The reason that's important is a lot of people ask, how do we know this drug is going to fly where it needs to? And part of this is based on all the history we have around understanding how FTKP is made, where it flies in the lung and how we bind the excipient through this. And we now have over 5,000 patients taking Tyvaso when you think about that, those patients have orphan lung disease of pulmonary hypertension, ILD, and I'm sure there are some with comorbidities of IPF and COPD. So now that we have two products approved on the platform, we're very excited to continue to move forward our next one here, which is really MNKD-201.

這很重要，因為很多人問，我們如何知道這種藥物能夠到達需要的地方？這部分是基於我們對 FTKP 的生成方式、它在肺部的作用位置以及我們如何透過這種方式結合賦形劑的了解。想想看，現在我們有超過 5,000 名患者服用 Tyvaso，這些患者患有肺動脈高壓 (ILD) 等孤兒肺病，而且我相信其中一些患者還患有 IPF 和 COPD 的合併症。現在我們已有兩款產品在平台上獲得批准，我們非常高興能夠繼續推進我們的下一款​​產品，也就是 MNKD-201。

As you know, IPF is a growing therapeutic area with over $4.2 billion in sales in 2022, and this continues to grow each year with the majority of those made up of OFEV, which is a great product. It's one of two only drugs approved, but it does have severe GI side effects, which limit patients' ability to stay on the product.

眾所周知，特發性肺纖維化 (IPF) 是一個不斷增長的治療領域，2022 年的銷售額將超過 42 億美元，而且這一數字每年都在持續增長，其中大部分是由 OFEV 實現的，這是一款出色的產品。它是僅有的兩種核准藥物之一，但它確實有嚴重的胃腸道副作用，限制了患者繼續服用該產品的能力。

So as we try to think about how we develop improved products, really, this was the opportunity to lower the systemic exposure while maximizing lung exposure. And we're really happy to see in our Phase 1 study here, which is where we tried three doses, we'll call them cohort A1, A2, A3, followed by multiple ascending dose over seven days where we tested A1 and A2 dosing. We really didn't need to go to A3, but we wanted to make sure it was safe and tolerable for that data to happen in the future.

因此，當我們試圖思考如何開發改進的產品時，這實際上是一個降低全身暴露同時最大限度地提高肺部暴露的機會。我們非常高興地看到，在我們的第 1 階段研究中，我們嘗試了三種劑量，我們將它們稱為 A1、A2、A3 組，然後在 7 天內多次增加劑量，其中我們測試了 A1 和 A2 劑量。我們確實不需要去 A3，但我們希望確保將來這些資料的出現是安全且可以容忍的。

Overall, this trial was a success. We saw no dose-limiting toxicities or dose implications on FEV1. And we also saw, in our chronic tox study, no significant signals or adverse event findings that would prevent us from moving forward in a chronic administration of this product. So we're really happy to wrap these two things up. We will meet with the FDA on our proposal for further development to move this into a Phase 2/3, hopefully here in 2025. This is a very exciting time for MannKind as these will be two assets we have going into full-scale clinical trials, which will pave the way for future exponential growth for MannKind.

整體來說，這次試驗是成功的。我們沒有發現劑量限制性毒性或劑量對 FEV1 的影響。而且，在我們的慢性毒性研究中，我們尚未發現任何重大訊號或不良事件發現，阻止我們繼續長期使用該產品。所以我們非常高興能夠解決這兩件事。我們將與 FDA 會面，討論進一步開發的建議，以將其推進到第 2/3 階段，希望能夠在 2025 年完成。對於 MannKind 來說，這是一個令人興奮的時刻，因為這是我們進入全面臨床試驗的兩項資產，這將為 MannKind 未來的指數級增長鋪平道路。

I now want to bridge over to our diabetes business, where we had the first large trial readout this year that we've been investing in over the last couple of years. This trial was designed to really look at usual care, which is inclusive of automated insulin delivery pumps, mainly Tandem and Omnipod in this trial as well as patients on MDI, and then comparing that to a single shot of Degludec, plus Afrezza.

現在我想談談我們的糖尿病業務，我們今年進行了首次大型試驗讀數，過去幾年我們一直在投資這項業務。這項試驗的目的是真正觀察常規治療，包括自動胰島素輸送泵，主要是本次試驗中的 Tandem 和 Omnipod 以及使用 MDI 的患者，然後將其與單次注射 Degludec 和 Afrezza 進行比較。

And then at the end of 17 weeks, these patients were given a second meal challenge and we could see in the first and second meal challenge significant improvement in postprandial control in the first 2 hours. And then at 17 weeks, everybody went into a single-arm trial at this point and either you rolled over from the Afrezza degludec or you switched to usual care.

然後在 17 週結束時，這些患者接受第二次進餐挑戰，我們可以在第一次和第二次進餐挑戰中看到前 2 小時內餐後控制有顯著改善。然後在 17 週時，每個人都進入單臂試驗，此時，你要么停止使用 Afrezza degludec，要么轉而使用常規治療。

And what you see here on the next slide is we just released the 30-week data. I'm really proud to see that the longer you want Afrezza here on the top left, you can see your A1c continue to improve over time. We also continue to see more people getting to goal, -- almost 42% got to goal, which is unbelievable here as it's a very tough disease, type 1, where the large majority of patients do not get to goal today.

您在下一張投影片上看到的是我們剛發布的 30 週數據。我真的很自豪地看到，你服用左上角 Afrezza 的時間越長，你就能看到你的 A1c 隨著時間的推移不斷改善。我們也看到越來越多的人達到了目標——幾乎有 42% 的人達到了目標，這是令人難以置信的，因為這是一種非常難治的疾病，即 1 型疾病，目前絕大多數患者都無法達到目標。

The second part of this study was the readout of those who switched from 17 weeks usual care and what happened to them at 30 weeks. And you can see as clinicians got more experience with Afrezza, we saw an improvement in A1c in those 13 weeks of taking the product plus we're able to see twice as many people get to goal here on the right side in 13 weeks, which is important as we think about the trial and what Afrezza can do.

本研究的第二部分是讀取那些從 17 週常規護理轉換而來的患者的情況以及他們在 30 週時的情況。您可以看到，隨著臨床醫生對 Afrezza 的經驗越來越豐富，我們在服用該產品的 13 週內看到 A1c 有所改善，而且我們看到 13 週內達到目標的人增加了一倍，這對於我們考慮試驗和 Afrezza 的作用非常重要。

And I'll remind you, these are people who are already on the optimized treatments. They've been living with diabetes a long time. And by switching them to Afrezza, we were able to drive more people to goal, which is ultimately a huge benefit to society.

我要提醒你們，這些人已經接受了優化治療。他們已經患有糖尿病很久了。透過讓他們改用 Afrezza，我們能夠讓更多的人達到目標，最終將為社會帶來巨大的利益。

Now let's shift over to our revenues year-to-date. When we look at the EBU, profitability has been our focus this year. And when you think about the growth and the transformation we've had, Afrezza grew 16% year-over-year, while V-Go was slightly down as we shifted to managing V-Go for profitability this year away from volume, and we've been really happy with those outcomes.

現在我們來看看今年迄今為止的收入。當我們審視 EBU 時，獲利能力一直是我們今年關注的重點。當您想到我們所經歷的成長和轉型時，您會發現 Afrezza 同比增長了 16%，而 V-Go 則略有下降，因為今年我們已將重點從銷量轉向盈利能力，我們對這些結果感到非常滿意。

And then on year-to-date, overall for the business, you can see this year versus last year, it's about a $12 million improvement in bottom line contribution between managing our expenses, improving our efficiency on COGS and continuing to drive more to the bottom line.

然後從年初至今的整體業務來看，你可以看到今年與去年相比，我們在管理費用、提高 COGS 效率和繼續增加利潤方面的貢獻增加了約 1,200 萬美元。

When we look at Q3, we're able to grow Afrezza despite multiple headwinds throughout this year. When we think about what happened earlier this year, we had payors put in double step edits. We had sales force restructuring compounded by a shift in inventory in Q3 as we exited our Walgreens consignment and one of our specialty pharmacies was told to shift patients back out to retail by Optum for all of their patients, not just Afrezza, and a lot of this caused hiccups as we went through each quarter through this year. This is all behind us as we close out Q4. And this was also followed by a mix of faster growth in 4 and 8 units versus 12, which is a direct reflection of our focus to grow more in the type 1 space versus type 2.

當我們回顧第三季時，我們發現儘管今年面臨多重阻力，Afrezza 仍然能夠成長。當我們回想今年早些時候發生的事情時，我們讓付款人進行了雙步編輯。由於我們退出了 Walgreens 寄售業務，第三季度庫存發生變化，我們進行了銷售團隊重組，並且我們的一家專科藥房被 Optum 要求將所有患者（而不僅僅是 Afrezza）轉移回零售店，這給我們今年每個季度都帶來了很多麻煩。隨著第四季的結束，這一切都已成為過去。緊隨其後的是，4 個單位和 8 個單位的成長速度快於 12 個單位的成長速度，這直接反映了我們更注重在 1 型空間而不是 2 型空間中實現更多的成長。

So when you look at all that noise, I'll say, going into Q4, we're excited by what we see because so far in the month of October, new prescriptions are up 8% year-over-year. This is our earliest leading indicator of our success as we look at this quarter on how we're going to do.

因此，當您看到所有這些噪音時，我想說，進入第四季度，我們對所看到的情況感到興奮，因為到目前為止，十月份的新處方同比增長了 8％。當我們展望本季的表現時，這是我們最早的成功領先指標。

In Q4, we also made a change by removing V-Go from the sales force to double down the focus on Afrezza's growth, and we increased our target incentives around hub referrals and new prescription growth as we exit this year. Given the outcomes of the INHALE-3 and the upcoming INHALE-1 pediatric results, we expect to continue to shift Afrezza from a profitability mindset to a growth mindset in 2025 and beyond.

在第四季度，我們也做出了改變，將 V-Go 從銷售團隊中移除，以加倍關注 Afrezza 的增長，並且我們在今年退出時增加了圍繞中心推薦和新處方增長的目標激勵措施。鑑於 INHALE-3 的結果以及即將公佈的 INHALE-1 兒科研究結果，我們預計在 2025 年及以後 Afrezza 將從獲利思維轉變為成長思維。

As we look here, I want to remind you of the pediatric opportunity. There are over 300,000 kids living with type 1 diabetes. This was a 52-week primary study in INHALE-1, ages 4 to 17, very little were type 2, majority were type 1. And the primary endpoint is at 6 months. And the data will be coming in here before the end of the year, so we'll be able to update shareholders. And we would expect a pre-NDA filing meeting in the first half.

當我們看到這裡時，我想提醒您兒科的機會。有超過 30 萬名兒童患有第 1 型糖尿病。這是一項為期 52 週的 INHALE-1 主要研究，研究對象年齡介於 4 至 17 歲之間，其中大多數為 1 型，很少有人是 2 型。主要終點是 6 個月。這些數據將在年底前公佈，以便我們能夠向股東通報最新情況。我們預計上半年將舉行一次保密協議提交前會議。

The real issue here is, do we want to try to argue that there should be a 6-month filing versus a 12-month filing as the 12-month data will come out roughly late Q2 next year, and the filing would happen after. If it's a 6-month filing, we'll be able to file that earlier in the year. But the FDA has indicated that they expect to see the 12-month data before we file.

這裡真正的問題是，我們是否要試圖爭辯說應該進行 6 個月的申報，而不是 12 個月的申報，因為 12 個月的數據將在明年第二季末左右發布，而申報將在之後進行。如果是 6 個月的申請，我們將能夠在年初提交。但 FDA 表示，他們希望在我們提交申請之前看到 12 個月的數據。

So as we look out, we got INHALE-3 coming with the label change request, as well as INHALE-1 readout and you're also going to be seeing an IRT we're funding in gestational diabetes very shortly. So we continue to look at Afrezza's multitude of growth opportunities in the coming years.

因此，據我們觀察，我們得到了 INHALE-3 和標籤變更請求，以及 INHALE-1 讀數，您很快就會看到我們為妊娠糖尿病提供資助的 IRT。因此，我們將繼續關注未來幾年 Afrezza 的許多成長機會。

And let me stop there and turn it over to Chris to give us an update on our financials.

現在我停下來，把時間交給克里斯，讓他向我們報告我們的財務狀況的最新情況。

Thanks, Mike, and good afternoon, everyone. I am pleased to discuss our third quarter 2024 financial results. For a summary of our financials, please refer to our press release issued prior to this call and our 10-Q, which is on file with the SEC.

謝謝，麥克，大家下午好。我很高興討論我們 2024 年第三季的財務表現。有關我們的財務狀況摘要，請參閱本次電話會議之前發布的新聞稿和我們提交給美國證券交易委員會 (SEC) 的 10-Q 表。

As Mike mentioned, our business demonstrated robust double-digit revenue growth compared to last year, led by revenues related to Tyvaso DPI. Third quarter revenues were $70 million, which represent a 37% increase compared to last year's quarter.

正如 Mike 所說，我們的業務與去年相比實現了強勁的兩位數收入成長，其中主要由 Tyvaso DPI 相關收入推動。第三季營收為 7,000 萬美元，較去年同期成長 37%。

For the year-to-date, we recorded revenues of $209 million, a 49% increase over the prior year period. Looking at the details, Tyvaso DPI royalties contributed $27 million in third quarter revenue, an increase of 34% over the same quarter last year and $75 million or a 48% increase for the nine-month period.

今年迄今為止，我們的營收為 2.09 億美元，比去年同期成長 49%。具體來看，Tyvaso DPI專利費為第三季貢獻了2,700萬美元的收入，較去年同期成長34%，前九個月貢獻了7,500萬美元，成長48%。

On United Therapeutics Q3 earnings call, they noted the revenue growth was due to additional patients and an increase in price. They also commented that referrals and start patterns remain very robust, reinforcing their confidence in the durability of the growth profile.

在聯合治療公司第三季財報電話會議上，他們指出收入成長得益於患者數量的增加和價格的上漲。他們還評論說，推薦和啟動模式仍然非常強勁，這增強了他們對成長概況持久性的信心。

Collaboration and services revenue was $23 million, a 78% increase from the third quarter of 2023. For the nine-month period, we recorded $74 million, a 108% increase compared to the same period in 2023. The increase over the prior year period was primarily attributable to increased manufacturing activities for Tyvaso DPI.

協作與服務收入為 2,300 萬美元，較 2023 年第三季成長 78%。在這九個月期間，我們的營收達到 7,400 萬美元，與 2023 年同期相比成長了 108%。與去年同期相比的成長主要歸因於 Tyvaso DPI 的製造活動增加。

Collaboration and services revenue consists primarily of manufacturing revenue based on production activities sold through to UT and the recognition of deferred revenue. In the first half of 2024 and in prior years, we also earned approximately $3 million of revenue related to certain scale-up activities in the first half of 2024, resulting in the expected slight decline in the back half of the year.

協作和服務收入主要包括基於透過 UT 銷售的生產活動的製造收入以及遞延收入的確認。2024 年上半年及前幾年，我們也獲得了與 2024 年上半年某些擴大規模活動相關的約 300 萬美元的收入，導致預計下半年會出現小幅下降。

Afrezza net revenue for the third quarter was $15 million, a 12% increase due to higher demand and improved gross to nets. During the nine-month period, Afrezza revenue was $46 million, a 16% increase over the same period last year. This increase was due to higher demand, a price increase and improved gross to nets.

Afrezza 第三季淨收入為 1500 萬美元，由於需求增加和毛利與淨利潤比率提高而增長 12%。在這九個月期間，Afrezza 的營收為 4,600 萬美元，較去年同期成長 16%。這一增長是由於需求增加、價格上漲和毛利率提高。

V-Go net revenue was approximately $5 million for the third quarter, an increase of 5% and the nine-month period was approximately $14 million, a decrease of 6%. This is due to lower product demand, partially offset by improved gross to net adjustments and increased price.

V-Go 第三季淨收入約 500 萬美元，成長 5%，前九個月淨收入約 1,400 萬美元，下降 6%。這是由於產品需求下降，但毛利與淨利調整改善和價格上漲部分抵消了這種影響。

Our annual revenue trends from 2020 through the latest 12-month period also show a consistent increase with double-digit revenue growth year-over-year. These revenues and our management of the commercial business have led the results on the bottom line.

我們從 2020 年到最近 12 個月的年度收入趨勢也呈現持續成長的趨勢，並且比去年同期實現了兩位數的收入成長。這些收入以及我們對商業業務的管理已引領了獲利績效。

In the third quarter, we recorded GAAP net income of $12 million, which when adjusted for non-GAAP items, results in non-GAAP net income of $15 million. This compares to GAAP net income of $2 million in the prior year quarter and non-GAAP net income of $4 million.

第三季度，我們記錄的 GAAP 淨收入為 1,200 萬美元，經非 GAAP 專案調整後，非 GAAP 淨收入為 1,500 萬美元。相比之下，去年同期的 GAAP 淨收入為 200 萬美元，非 GAAP 淨收入為 400 萬美元。

For the nine-month period of 2024, we reported net income of $20 million and non-GAAP net income of $45 million, whereas for the same period in 2023, we reported a net loss of $13 million and a non-GAAP net loss of $1 million.

2024 年九個月期間，我們報告的淨收入為 2,000 萬美元，非 GAAP 淨收入為 4,500 萬美元，而 2023 年同期，我們報告的淨虧損為 1,300 萬美元，非 GAAP 淨虧損為 100 萬美元。

As we highlighted earlier on the call, last year, we transitioned to running the endocrine business unit for profitability, which has contributed approximately $11 million year-to-date in operating income. This, combined with our net royalty income and the margin earned from collaboration and services has allowed us to fund our two promising development programs to date and also achieved net income of $20 million for the year-to-date period and $45 million non-GAAP.

正如我們早些時候在電話會議上所強調的那樣，去年，我們轉型為營運內分泌業務部門以實現盈利，該部門今年迄今已貢獻了約 1,100 萬美元的營業收入。這項收入加上我們的淨特許權使用費收入以及從合作和服務中獲得的利潤，使我們能夠為迄今為止的兩個有前景的開發項目提供資金，並且年初至今實現了 2000 萬美元的淨收入和 4500 萬美元的非 GAAP 淨收入。

The operational execution of our business, combined with our cash and investments of $268 million as of the end of September, leaves us with a strong balance sheet and the ability to invest in the business for growth.

我們業務的營運執行力，加上截至九月底的 2.68 億美元現金和投資，使我們擁有強勁的資產負債表和投資業務成長的能力。

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

說完這些，我將把電話轉回給麥克。

Thank you, Chris. As we look back on 2024, we've executed all of the milestones we've laid out so far with the very last one coming up on INHALE-1, which we fully expect to share with the Street here by the end of the year. We're looking forward to closing out the year.

謝謝你，克里斯。回顧 2024 年，我們已經實現了迄今為止制定的所有里程碑，最後一個里程碑是 INHALE-1，我們完全希望在今年年底前與華爾街分享。我們期待著結束這一年。

As we look at the first half, we have several key regulatory updates coming around 201 with an end of Phase 1 meeting, Tyvaso DPI and the spray dry expansion hopefully coming online, 101 continued site activations around the world and patient enrollment and screenings continuing. We'll also be having discussions with the agency on our INHALE-1 readout and our INHALE-3 data label change as we go forward.

回顧上半年，我們將在 201 年左右迎來幾項關鍵的監管更新，第一階段會議即將結束，Tyvaso DPI 和噴霧乾燥擴展有望上線，全球 101 個站點將繼續激活，患者招募和篩檢也將繼續進行。我們還將與該機構討論我們的 INHALE-1 讀數和 INHALE-3 數據標籤變更。

The next adventure of the company is extremely exciting as we look at our key value drivers going forward. We have 101 with every 1,000 patients being $100 million in revenue. And as we look out in the NTM space, Arikayce is approaching $400 million in annual sales in 2025. We feel very good that this market helping NTM patients will be a very robust opportunity in the coming years.

當我們展望未來的關鍵價值驅動因素時，公司的下一次冒險極為令人興奮。我們有 101 名患者，每 1,000 名患者的收入為 1 億美元。放眼 NTM 領域，Arikayce 的年銷售額到 2025 年將接近 4 億美元。我們非常高興地看到，這個幫助 NTM 患者的市場在未來幾年將是一個非常強勁的機會。

201 - as we move that one forward, we think this has a real opportunity to help impact the patients' lives impacted with IPF, who suffer every day from severe diarrhea and GI side effects.

201 — 隨著我們推進這個項目，我們認為這是一個真正的機會，可以幫助改善受特發性肺纖維化 (IPF) 影響的患者的生活，他們每天都要忍受嚴重的腹瀉和胃腸道副作用的折磨。

As we think about Tyvaso DPI, it's hard for us to control that revenue stream, but we try to give you clarity that we continue to see very strong demand growth in manufacturing opportunities and that for every 10,000 patients here is roughly $300 million to $350 million in revenue to MannKind.

當我們考慮 Tyvaso DPI 時，我們很難控制該收入流，但我們試圖讓您清楚地知道，我們繼續看到製造機會的強勁需求增長，並且每 10,000 名患者將為 MannKind 帶來約 3 億至 3.5 億美元的收入。

With the upcoming readouts next year of TETON 1 and 2, we're extremely excited about this IPF opportunity as well as TETON-PPF, looking for it to continue to leverage the manufacturing scale that we built up as well as the opportunity to help a whole another area of patients suffering from IPF.

隨著明年 TETON 1 和 2 的即將公佈，我們對這個 IPF 機會以及 TETON-PPF 感到非常興奮，希望它能夠繼續利用我們建立的製造規模以及幫助另一個領域患有 IPF 的患者的機會。

Within the endocrine space, I want to remind you, the pediatrics, every 10% share is roughly $150 million in net revenue. We feel very comfortable if we can get this indication, we'll be able to achieve a substantial opportunity in children to make their lives hopefully better than what they go through today. The INHALE-3 study we'll be reading out, we're just starting to educate our sales force and customers around this data. And we also will have international expansion updates as we progress throughout 2025. We're looking forward to bringing all this forward and landing us in a continued growth opportunity in the years to come.

在內分泌領域，我想提醒你，兒科每 10% 的份額大約是 1.5 億美元的淨收入。如果我們能夠得到這個跡象，我們會感到非常欣慰，我們將能夠在孩子身上獲得實質的機會，希望他們的生活比現在更好。我們將要讀出的 INHALE-3 研究結果，我們才剛開始向我們的銷售人員和客戶介紹這些數據。隨著 2025 年的到來，我們也將更新國際擴張計畫。我們期待著推動這一切，並在未來幾年為我們帶來持續的成長機會。

We'll have several opportunities to share scientific and investor updates here in Q4 as well as Q1 next year. Starting off with the UBS Global Healthcare Conference next week, we'll be there on Tuesday, followed by an opportunity we invited with Oppenheimer here on December 12 in New York for the Rare Disease Summit. And we'll also be attending the ATTD conference, where we already had several abstracts and presentations accepted around our INHALE-3 data and possible INHALE-1 as we find out more notifications being acceptance. So we have several opportunities to continue to update you as well as our key stakeholders in the scientific community around our key datasets in 2025.

我們將有幾次機會在明年第四季和第一季分享科學和投資者的最新消息。從下週的瑞銀全球醫療保健會議開始，我們將於週二出席，隨後我們將有機會與奧本海默一起於 12 月 12 日參加在紐約舉行的罕見疾病高峰會。我們還將參加 ATTD 會議，在該會議上，我們的 INHALE-3 數據和可能的 INHALE-1 數據方面的幾篇摘要和演示文稿已被接受，因為我們發現有更多通知被接受。因此，我們有多次機會繼續向您以及科學界的關鍵利害關係人通報 2025 年的關鍵資料集。

These are just a few as we start out the year and looking forward to hopefully many more opportunities in 2025 to communicate with you and our other key stakeholders. Thank you very much. We look forward to closing out the year strong and appreciate your continued support. We'll now open up for Q&A.

這些只是我們在新年伊始所做的一些事情，我們希望在 2025 年有更多機會與您和我們其他主要利害關係人溝通。非常感謝。我們期待以強勁的勢頭結束新的一年，並感謝您一直以來的支持。我們現在開始問答環節。

(Operator Instructions) Andreas Argyrides, Oppenheimer.

（操作員指示） Andreas Argyrides，奧本海默。

Congrats on all the progress this quarter. Two questions from us. Regarding 101, can you just give us a sense in thinking about Arikayce and the number that you provided, what percentage penetration that is of the market? And then where does 101 fit in that and how much bigger can it be?

恭喜本季取得的所有進展。我們有兩個問題。關於 101，您能否讓我們了解一下 Arikayce 以及您提供的數字，其市場滲透率是多少？那麼 101 在哪裡才合適呢？

And then for 201, can you just give us a little bit more detail on the Phase 1 and how that helps inform the Phase 2/3 design, what you may see from an efficacy standpoint? And then maybe a little bit more detail on the timelines, if you could. I appreciate that.

然後對於 201，您能否向我們詳細介紹第 1 階段以及這如何有助於指導第 2/3 階段的設計，從功效的角度來看您可能會看到什麼？如果可以的話，您能否進一步詳細說明時間表。我很感激。

Sure. Thank you, Andreas. I think it came in a little blurry, but I think I heard your first question was on 101 around ARIKAYCE penetration and where does 101 fit in. And as we look at the landscape, I think the first thing is hopefully displacing Arikayce in the refractory population as the administration and hopefully tolerability of 101, if it works efficacy-wise, should sustain the ability to do that very well.

當然。謝謝你，安德烈亞斯。我覺得有點模糊，但我想我聽到你的第一個問題是關於 101 圍繞 ARIKAYCE 的滲透率以及 101 適合在哪裡。當我們審視情勢時，我認為首先希望在難治性患者群體中取代 Arikayce，因為如果 101 在療效方面有效，那麼它的管理和耐受性應該能夠很好地維持這一效果。

The second area is we are down to a final formulation selection very shortly on 101. And mid to long term, we also expect to bring a dry powder formulation out that would help penetrate earlier lines of treatment. And so our ultimate goal is to be used first line and second line or refractory between a dry powder and a nebulizer. Just the nebulizer was the faster way to market.

第二個方面是我們很快就要對 101 進行最終的配方選擇。從中長期來看，我們也希望推出一種乾粉配方，有助於滲透早期治療。因此，我們的最終目標是成為一線和二線使用或乾粉和霧化器之間的難治之藥。僅霧化器就是最快的上市方式。

And so they're right on top of each other in the grand scheme of things, but that's generally where we expect to be able to compete in early and late lines of treatment in NTM. We'll give further updates in terms of that strategy in a bridging study, or new study sometime in '25.

因此，從總體上看，它們是相互競爭的，但我們通常期望它們能夠在 NTM 的早期和晚期治療中相互競爭。我們將在 2025 年的一項橋接研究或新研究中對該策略進行進一步的更新。

The 201 details on how that informs the study -- I think the first thing was making sure the chronic tox data was okay because that to us was the first step in this area. And then the Phase 1 study was really looking to see what, if any, GI side effects could have occurred. Or was there anything related to OFEV type side effects that would give us concern or at least confirming our thesis that they should be minimal, which is what we expected and they were.

201 詳細說明如何為研究提供資訊——我認為第一件事是確保慢性毒性數據沒有問題，因為對我們來說，這是該領域的第一步。第一階段的研究其實是想看看是否會出現胃腸道副作用。或者是否存在與 OFEV 類型的副作用相關的任何因素會讓我們擔心，或者至少證實我們的論點，即這些副作用應該是微乎其微的，這正是我們所期望的，事實也確實如此。

And then the second part of that is while they were healthy volunteers, it was the first time we're really putting Nintedanib in a healthy volunteer lung. And we're pretty confident in FTKP, as I stated earlier in the call, but demonstrating that there was no adverse reaction to Nintedanib we can clearly see in the Phase 1, whether it's the control arm or the, I'll call it, placebo or the active, there was no indicators or any concerns for that. So that really shapes us up for the Phase 2.

第二部分是，當他們是健康志工時，這是我們第一次真正將尼達尼布放入健康志工的肺部。正如我早些時候在電話會議上所說的那樣，我們對 FTKP 非常有信心，但我們在第 1 階段可以清楚地看到，無論是對照組還是我稱之為安慰劑或活性劑，都證明對尼達尼布沒有不良反應，都沒有任何指標或擔憂。所以這確實為我們的第二階段做好了準備。

We know the FDA in their preliminary comments wanted a dose range finding study. So that's what we'll go to them with next year. So we're trying to get to either a Phase 2/3 bridge or even just go to our single dose that we want to target and see whether we could down a dose if somebody had tolerability issues. But until we meet with the FDA, I think it's all -- we can't really predict where their heads are going to be, and we have a good rationale, but whether they agree or disagree is the question. So that's where we are. We expect to get there, hopefully, in Q1, and we'll provide updates as we meet with them.

我們知道 FDA 在其初步意見中希望進行劑量範圍探索研究。所以這就是我們明年要帶給他們的東西。因此，我們正嘗試進入第 2/3 階段橋樑階段，或者甚至只採用我們想要的單劑量，並查看如果​​有人出現耐受性問題我們是否可以減少劑量。但在我們與 FDA 會面之前，我認為我們無法真正預測他們的想法，我們有充分的理由，但他們是否同意或不同意是一個問題。這就是我們現在的狀況。我們期望能在第一季實現這一目標，並且我們會在與他們會面時提供最新消息。

Olivia Brayer, Cantor Fitzgerald.

奧莉維亞·布雷爾，費茲傑拉領唱者。

What more can you tell us about MNKD-201's profile just in terms of any differentiation you've seen so far? You guys are obviously not the only ones developing an inhaled version of the drug. And did you guys look at PK as it relates to the oral formulation? If so, any comparisons there?

就您目前所看到的差異而言，您還能告訴我們有關 MNKD-201 概況的更多資訊嗎？顯然，你們並不是唯一會開發吸入式藥物的人。你們是否研究過 PK 與口服製劑的關係？如果有，有任何可比較的嗎？

Sure. I think the -- I think, first of all, we're probably in a speed to move this into patients in a bigger way. And I believe we have the ability to do that in the dry powder formulation in terms of CMC, is pretty much ready as well as our trial design. So it's really just getting this to the FDA.

當然。我認為—我認為首先，我們可能正在加速將其更大規模地推廣到患者身上。我相信我們有能力在 CMC 乾粉配方中做到這一點，我們的試驗設計也已經準備就緒。所以實際上只是把它交給 FDA。

I think in terms of -- one can ask, is there a difference in a nebulizer versus a dry powder? We probably have a little bit of a bias towards dry powder given our company history and background and the success of Tyvaso DPI and what we saw there over their nebulizer.

我認為——有人可能會問，霧化器和乾粉有什麼區別嗎？考慮到我們公司的歷史和背景以及 Tyvaso DPI 的成功以及我們在其霧化器上看到的情況，我們可能對乾粉有一點偏見。

So that's really our -- also our key points of differentiation as we go forward. I think there's always enough room in the market for two players. So it's really about making a difference in the patients' lives and letting competition compete. But we think that this disease requires hopefully some innovation that we can bring to the marketplace.

所以這確實也是我們前進過程中的關鍵差異點。我認為市場上總是有足夠的空間容納兩名球員。因此，這實際上是為了改變患者的生活並讓競爭對手競爭。但我們認為，這種疾病需要一些我們可以推向市場的創新。

In terms of the clinical differentiation, as you may or may not realize, these patients take immense amounts of Imodium just to try to stay on OFEV. And that will be some of the stuff we look at is, do we reduce the amount of Imodium, do we reduce diarrhea?

就臨床區分而言，您可能意識到或沒有意識到，這些患者服用大量的 Imodium 只是為了嘗試繼續服用 OFEV。我們要研究的是，我們是否減少 Imodium 的用量，是否能減少腹瀉？

Our proposal to the FDA is a combination of naive and experienced patients. So hopefully, we'll be able to see a GI side effect from OFEV versus us in that profile. Again, the FDA could change our trial design, and we would focus only on experienced patients potentially.

我們向 FDA 提出的建議是初級患者和有經驗的患者相結合。因此，希望我們能夠在該概況中看到 OFEV 與我們相比的胃腸道副作用。再次，FDA 可能會改變我們的試驗設計，我們可能會只關注有經驗的患者。

But otherwise, we think the administration is not going to be the biggest burden in terms of a pill versus inhaled, but the side effect profile of OFEV is really what we're going after. And hopefully, we can get higher lung concentration.

但除此之外，我們認為與吸入劑相比，服用藥片不會成為最大的負擔，但我們真正關注的是 OFEV 的副作用。希望我們能夠獲得更高的肺濃度。

We did measure plasma PK in this trial, not to compare it to OFEV, but just to kind of triangulate to our animal models to see where we were. And that data is still coming in as we speak. So we'll have that full analysis before we go to the FDA.

我們確實在本次試驗中測量了血漿 PK，並不是為了將其與 OFEV 進行比較，而只是為了與我們的動物模型進行三角測量，以了解我們所處的位置。正如我們所說，數據仍在不斷湧入。因此，在向 FDA 提交報告之前，我們會進行全面的分析。

Okay. Understood. And then just in terms of kind of data disclosure for measuring plasma and PK, is the -- should we expect to see that sometime next year? Or is that something that you'll just go to the FDA with and not necessarily present at a medical meeting or publish?

好的。明白了。那麼就測量血漿和 PK 的數據揭露而言，我們是否應該期待明年某個時候看到它？或者這只是你會去 FDA 的東西，而不一定在醫學會議上展示或發表？

I don't want to speculate yet because I don't know what the data says relative to our animals and how would we triangulate that or put some information out there. I do think people have been asking around the bleomycin study in this. And so we'll think about how we can bring some more articulation of our confidence as we go forward and what that trial design looks like and the data behind the support around that.

我還不想猜測，因為我不知道數據對我們的動物來說意味著什麼，以及我們如何對其進行三角測量或將一些資訊發佈出來。我確實認為人們一直在詢問有關博來黴素的研究。因此，我們會思考如何在前進的過程中更表達我們的信心，以及試驗設計的樣子和支持它背後的數據。

And that's probably the one area I think we're still having some internal discussion on, which is do you do a smaller Phase 2 just to get the efficacy data so people could see that sooner. And then that will take a little bit longer of a Phase 2 than a Phase 3, but it would give people more certainty. And so those are some of the discussions between the FDA and our internal clinical development team.

我認為這可能是我們仍在進行內部討論的一個領域，即是否進行較小規模的第 2 階段研究以獲取功效數據，以便人們能夠更快地看到效果。第二階段所花的時間會比第三階段稍微長一點，但它會給人們更多的確定性。這些就是 FDA 和我們的內部臨床開發團隊之間的一些討論。

Faisal Khurshid, Leerink Partners.

Faisal Khurshid，Leerink Partners。

I just wanted to ask if you could say a little bit more around the adverse event profile that you saw in the Phase 1 for the inhaled nintedanib. Like with the FEV drop and cough events, could you tell us a little bit more about your hypothesis around what caused that? Like, is that excipient-related? And just anything around like kind of time course of those events? And just any more insight you can give around that?

我只是想問您是否可以再多說一下吸入性尼達尼布第一階段所觀察到的不良事件概況。就像 FEV 下降和咳嗽事件一樣，您能否告訴我們更多關於導致這一現象的原因的假設？例如，這與賦形劑有關嗎？還有這些事件的時間進程嗎？您還能提供更多見解嗎？

Yeah. There was no -- I think in the 7-day part, we look to see, did it get worse over the 7 days? Did people have it on day 1, have it on day 7? The bottom line is there were no real concerns around the drop or the significance of the drop or it didn't continue to get worse. In fact, no one discontinued because of it. So people that may have it day 1, may not have had it on day 7. Some people didn't have it on day 1, got on day 7. So there was no consistency about when or how it appeared.

是的。沒有——我認為在 7 天的時間裡，我們會觀察情況在 7 天內是否變得更糟？人們在第一天就有它，在第七天也有它嗎？底線是，對於下降或下降的重要性並沒有真正的擔憂，或者情況沒有繼續惡化。事實上，沒有人因此而停止。因此，第一天患有這種疾病的人，可能第七天就沒有這種疾病了。有些人第一天沒有，但第七天才有。因此它何時出現、如何出現並不一致。

There is one thing I'll highlight for you that I think is important is these patients had to do an FEV-1, I think, like every 15 minutes roughly. So there was like four to five FEV-1s in the hour to 2 hours post dosing. And so that itself would have a lot of irritation of the lung. And that's something that the FDA wanted. So we did it, but I'm not sure it's going to tell us much. We'll look at the summary of all that data.

我要向您強調的一點是，我認為很重要的一點是這些患者必須大約每 15 分鐘進行一次 FEV-1 檢測。因此，服藥後 1 至 2 小時內 FEV-1 約為 4 至 5 個。這本身就會對肺部造成很大的刺激。這正是 FDA 想要的。所以我們這樣做了，但我不確定這是否會告訴我們很多。我們將查看所有數據的摘要。

But there was a lot of, I'll say, administration of FEV-1 throughout the time period of measurement. And so we're looking at total FEV-1 drops from the initial dose all the way through 2 hours, and that's after repeated FEV-1s per patient.

但我要說的是，在整個測量期間，FEV-1 的施用量很大。因此，我們正在觀察從初始劑量到 2 小時內的總 FEV-1 下降情況，這是每位患者重複 FEV-1 之後的結果。

So there's a lot of data drawn, a lot to still be summarized, but there was nothing at the highest level when we looked at the data that was of concern or consistency, I'll say. And it seemed to happen in both the control as well as the active arm. So there wasn't anything specifically around nintedanib that we would say is -- so I think it's much more around putting dry powder into the lung than anything and the frequency of FEV-1 testing that was required.

因此，我們收集了大量數據，還有很多數據有待總結，但我想說，當我們查看最高級別的數據時，並沒有什麼值得關注或一致的東西。這似乎在對照組和活動組中都有發生。因此，我們無法具體說明尼達尼布的作用 — — 所以我認為這更多的是關於將乾粉注入肺部，以及所需的 FEV-1 測試頻率。

Yes. That sounds like a workout. Just to clarify, the placebo arm was like just a straight excipient without nintedanib. So it's the same kind of dry powder inhalation just with no active drug?

是的。這聽起來像是鍛鍊。需要澄清的是，安慰劑組就像是沒有尼達尼布的直接賦形劑。那麼它和那種乾粉吸入劑是一樣的，只是沒有活性藥物嗎？

Yeah, FTKP is the excipient.

是的，FTKP 是賦形劑。

Gregory Renza, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。

Congrats on the progress this quarter. Just firstly, on 101, what's the broader value proposition from an economical standpoint for patients and physicians to use MannKind 101 over Arikayce or even oral clofazimine in NTM. Maybe if you have some early thoughts on where you'd like to land on out-of-pocket cost. And then just to key in on Tyvaso or Tyvaso DPI and the TETON-IPF and PPF studies, might 201 also be clinically usable in PPF? I know there's some research out there. Just wanted to get your thoughts.

恭喜本季取得的進展。首先，關於 101，從經濟角度來看，對於患者和醫生來說，在 NTM 治療中使用 MannKind 101 而不是 Arikayce 甚至口服氯法齊明的更廣泛的價值主張是什麼。也許如果您對自付費用有一些初步想法。然後只需關注 Tyvaso 或 Tyvaso DPI 以及 TETON-IPF 和 PPF 研究，201 是否也可用於 PPF 臨床？我知道那裡有一些研究。只是想聽聽你的想法。

Yeah. We saw another company switched from IPF to PPF, I think we'll see some results in IPF next year with the TETON 1 and 2. So I think there is an opportunity there, to your point. Some of that will be -- we would expect to get, in my mind, an extrapolation of indication. So if we look at what nintedanib has indicated for, I think it's really picking the right population with the right trial to get the right endpoint. And I think as part of our request with the FDA, just like we got ILD with Tyvaso DPI, we would hope to get extrapolation with that focus. So that would be our first focus on that.

是的。我們看到另一家公司從 IPF 轉向 PPF，我認為明年我們將透過 TETON 1 和 2 在 IPF 中看到一些成果。所以我認為那裡有一個機會，正如你所說。在我看來，其中一些將是—我們期望得到的是一個指示的推論。因此，如果我們看看尼達尼布的適用範圍，我認為真正重要的是選擇正確的人群進行正確的試驗以獲得正確的終點。我認為，作為我們向 FDA 提出的請求的一部分，就像我們透過 Tyvaso DPI 獲得 ILD 一樣，我們希望透過這一重點獲得推論。所以這將是我們首先關注的重點。

But to your point, maybe we could go after PPF instead of IPF if we really wanted to. And I think that's still an ongoing discussion, but I think a lot of this is the bigger population of IPF and the predictability of enrollment in that trial.

但正如您所說，如果我們真的願意的話，也許我們可以追求 PPF 而不是 IPF。我認為這仍是一個持續的討論，但我認為這很大程度上是因為 IPF 患者群體較大，而且該試驗入組人數的可預測性較高。

I'll bridge over to your 101 question on the brand value proposition. So I think when you look at clofazimine, it's in all the guidelines, doctors really love it. Our team is over in Asia right now and Australia activating sites and kicking off the investigator meetings over there. And clofazimine has much more wider use, I'll say, in those markets. And so the receptivity of our nebulizer form is very high and the belief in clofazimine as a treatment for NTM is very high.

我將回答您關於品牌價值主張的第 101 個問題。因此我認為，當你看到氯法齊明時，它符合所有的指導方針，醫生們真的很喜歡它。我們的團隊目前正在亞洲和澳洲啟動站點並在那裡啟動調查員會議。我想說，氯法齊明在這些市場上有更廣泛的用途。因此，我們的霧化器形式的接受度非常高，並且對氯法齊明作為 NTM 治療方法的信任度非常高。

And when you think about the couple of side effects of clofazimine, in particular, oral formulation, you're getting skin discoloration, QT prolongation and potentially organ accumulation. So those are three things you don't want that with the reduced dose in the systemic circulation, but better concentration in the lungs, we would see a better value prop.

當您考慮氯法齊明的幾種副作用時，特別是口服製劑，您就會出現皮膚變色、QT 間期延長和潛在的器官蓄積。因此，這是您不希望看到的三件事，即體循環中的劑量減少，但肺部的濃度更好，我們會看到更好的價值主張。

And then combine that, I think, with Arikayce is an aminoglycoside, so it's got ototoxicity by nature. And I do believe those will be clinically differentiated, especially as you get to infectious disease docs and hospitals who are used to dealing with these things. I think there'll be a clinical differentiation, potentially a safety one. Again, we got to get trial results before we get too excited. But I think conceptually, that's where our heads are.

然後結合起來，我認為，Arikayce 是一種氨基糖苷類藥物，因此它本質上具有耳毒性。我確實相信這些在臨床上會有區別，特別是當你接觸到習慣處理這些事情的傳染病醫生和醫院時。我認為會存在臨床區別，也可能存在安全性區別。再次強調，我們必須在過度興奮之前得到試驗結果。但我認為從概念上來說，這就是我們的想法。

And then you get to the dosing administration. Every day, cleaning a device for 6 months to 18 months of your life is a burden. And that's one of the reasons we chose the dosing we did with clofazimine, which is 28 days on and 56 days off. One is the use of a nebulizer and the PK/PD of the product allows us to probably get that long.

然後你就可以進行劑量管理了。每天清潔一個設備，佔據你生命中的 6 個月到 18 個月的時間，是一項負擔。這就是我們選擇氯法齊明劑量的原因之一，即服藥28天，停藥56天。一種是使用霧化器，產品的 PK/PD 使我們可能能夠獲得那麼長時間。

And then the second is the co-pay burden on the patient. And so there is no real incentive to the doctors to use, I'll call it, nebulizer or an oral form of a product unlike diabetes where there's an incentive to use an insulin pump that doesn't happen in this disease.

第二是病人的共同支付負擔。因此，對於醫生來說，沒有真正的動力去使用霧化器或口服形式的產品，這與糖尿病不同，糖尿病患者有使用胰島素幫浦的動力，而這種疾病不會發生這種情況。

But being able to really get that nebulizer down to once a month, which should remain one co-pay to the patient. And so while the overall WAC cost for month supply will probably be comparable to a three-month supply, I would say that, that duration of effect will last year to three months and the co-pay will be a one-month thing. And that's important, especially for Medicare, which is generally capped per month as we go into '25. So that's kind of the value prop on the cost economic side and the dosing and safety that we're thinking about.

但實際上，能夠將霧化器的使用次數減少到每月一次，這仍然是患者共同支付的費用。因此，雖然一個月供應的總 WAC 成本可能與三個月供應相當，但我想說，效果持續時間將持續一年到三個月，共同支付將是一個月的費用。這很重要，尤其是對於醫療保險而言，進入25年後，醫療保險每月的保費通常會達到上限。所以這就是我們正在考慮的成本經濟面向以及劑量和安全性的價值主張。

Brandon Folkes, Rodman.

布蘭登·福克斯，羅德曼。

Congratulations on the progress during the quarter. I actually want to switch gears and talk a little bit about Afrezza. Can you just talk about the growth in Afrezza and sort of especially the growth in terms of the breadth and depth of prescribers? And what is the unaided awareness out there in the market just in the investment that MannKind has put into Afrezza data over the last year? Is there some level of anticipation of that data among your current prescribing community?

恭喜本季取得的進展。我其實想換個話題，稍微談一下 Afrezza。您能談談 Afrezza 的成長情況，特別是處方廣度和深度方面的成長嗎？那麼，對於 MannKind 去年對 Afrezza 數據的投資，市場上純粹的認知度如何呢？您目前的處方社群是否對這些數據有一定程度的期望？

And then how do we see the Afrezza commercial footprint evolving over time just given that backdrop, especially as we sort of move into the pediatric label and then sort of really make a move on the inhale -- (inaudible) inhale data?

那麼，在這樣的背景下，我們如何看待 Afrezza 的商業足跡隨著時間的推移而發展，特別是當我們進入兒科標籤並真正在吸入 - （聽不清楚）吸入數據方面取得進展時？

Thank you, Brandon. Nice to hear from you. There's a few questions wrapped up in there. And so I would say the unaided awareness of Afrezza amongst doctors is what we'd expect given the investment in our narrow target, meaning we target probably about 4,000 to 5,000 docs in any given quarter. And the number that actually write on a consistent basis is obviously much less.

謝謝你，布蘭登。很高興收到你的來信。這裡面牽涉到幾個問題。因此我想說，考慮到我們針對狹窄目標的投資，醫生對 Afrezza 的直接認知度是我們預期的，這意味著我們在任何特定季度的目標客戶群大概是 4,000 到 5,000 名醫生。而真正持續寫作的人數顯然要少得多。

And so that gets you to our focus, which is not broadening prescribers right now, it's actually going deeper with the current prescribers who've used the product because we got to a point this year where we really reduced our sales force from roughly 80 people down to 50. And so with that 40% cut, we had to go narrow and deep.

這樣就涉及了我們的重點，我們現在的重點不是擴大處方者，而是更深入地了解目前使用該產品的處方者，因為今年我們的銷售人員已經從大約 80 人減少到了 50 人。因此，對於那 40% 的削減，我們必須採取狹隘而深入的措施。

And that strategy seems to be working. We're seeing growth within our targets that we're really on top of. And we've seen that we've lost a little bit of scripts in the nontargets, I'll say, or in some of those docs that we had to leave with the reduction in the sales force. But the hope was we would make up that drop on those that we are targeting. So that does appear to be kind of making that transition as we got from Q2 to Q3 to early Q4.

而這項策略似乎正在發揮作用。我們看到了我們目標範圍內的成長，我們確實處於領先地位。我們發現，我們在非目標中丟失了一些腳本，或者說，在我們因銷售人員減少而不得不留下的一些文件中丟失了一些腳本。但我們希望能夠彌補我們目標數量的下降。因此，這確實似乎是一種轉變，就像我們從第二季到第三季再到第四季初一樣。

The other part that we are seeing in the endocrine space, and you can kind of see the insulin scripts, I think the overall TRx has dropped roughly 3% to 5% in Q3 in the overall rapid-acting mealtime market. And Afrezza obviously dropped from Q2 to Q3 a little bit. And some of that is we're seeing the endos switch from treating diabetes to actually treating weight loss. And they're just literally wholesale shifting their focus and their patient volumes.

我們在內分泌領域看到的另一部分，您可以看到胰島素腳本，我認為在整個速效餐時市場中，第三季的整體 TRx 下降了約 3％至 5％。而 Afrezza 的銷量從第二季到第三季明顯略有下降。其中之一是我們看到內分泌科的治療範圍從治療糖尿病轉向實際治療減肥。他們實際上正在全面轉移關注點和患者數量。

And so we'll see how that continues to play out. I don't expect it to impact Afrezza in a dramatic way because we have more than enough prescribers that we still need to help and work on. But that was some of our top prescribers. And that's why it is important to broaden our commercial focus beyond the ones that we do have.

因此我們將拭目以待事情將如何繼續發展。我並不認為這會對 Afrezza 產生巨大影響，因為我們有足夠的處方人員需要幫助和努力。但這是我們的一些頂級處方醫師。這就是為什麼擴大我們的商業關注點非常重要。

And overall, as we go forward, we want to kind of see the reaction to the INHALE-3 data. So that came out -- the 30-week data just came out a few weeks ago here. And that data will be published in a reputable journal probably in the next 4 to 8 weeks. And so that's been accepted. And then we have a bunch of presentations at ATTD, and we're just starting to educate the marketplace.

總的來說，隨著我們不斷前進，我們希望看到對 INHALE-3 數據的反應。所以這是——30 週的數據幾週前剛剛公佈的。該數據預計將在未來 4 到 8 週內發表在知名期刊上。所以這已被接受了。然後我們在 ATTD 上進行了大量演示，我們才剛開始向市場進行宣傳。

So we'll be looking to bring MSLs out in 2025 to really start to get into the academic centers and fellowship trainings and focus a little bit more on getting out from underneath the burden, I'll say, of the safety perceptions of inhaled insulin and how we start to put that on the table and move forward on the efficacy opportunities to help more patients.

因此，我們希望在 2025 年讓 MSL 真正開始進入學術中心和研究金培訓，並將更多的注意力放在擺脫吸入式胰島素安全性認知的負擔上，以及我們如何開始將其​​擺上檯面，並繼續探索療效機會以幫助更多的患者。

So it's a lot in your question, but I do think we got a good grasp of what's going on, and we feel pretty good about the direction we're going and our ability or desire to shift investment to grow it faster, at least put some resources behind key areas to make a difference.

你的問題涉及很多內容，但我確實認為我們很好地掌握了正在發生的事情，我們對我們的前進方向以及我們轉移投資以使其更快增長的能力或願望感到非常滿意，至少在關鍵領域投入一些資源以發揮作用。

And this does conclude the Q&A session for today. I would like to turn the call back over to management for closing remarks. Please go ahead.

今天的問答環節到此結束。我想將電話轉回給管理階層，請他們作最後發言。請繼續。

Thank you, Lisa, for moderating today, and thank you to all the MannKind team and our shareholders. We've had a great year so far. We're going to close the year strong. Looking really forward to 2025, and we'll continue to provide updates as things come in. But there's obviously a lot going on, all in a great way, and we look forward to continuing to open up that communication line and feel free to reach out with any questions. Thank you.

感謝 Lisa 今天的主持，也感謝整個 MannKind 團隊和我們的股東。到目前為止，我們度過了美好的一年。我們將以強勁的勢頭結束這一年。我們真誠地期待 2025 年，並​​將繼續提供最新進展。但顯然有很多事情正在發生，一切都進行得很順利，我們期待繼續開通這條溝通管道，如有任何問題，請隨時與我們聯繫。謝謝。

Thank you all for joining the conference call today. You may now disconnect.

感謝大家參加今天的電話會議。您現在可以斷開連線。