MannKind Corp (MNKD) 2023 Q4 法說會逐字稿

Good afternoon, and welcome to MannKind Corporation 2023 Fourth Quarter and Full Year Financial Results Earnings Call.

下午好，歡迎參加 MannKind Corporation 2023 年第四季和全年財務業績收益電話會議。

As a reminder, this call is being recorded on February 27, 2024, and will be available for playback on the MannKind Corporation website shortly after the conclusion of the call until March 12, 2024 this call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from those stated expectations. For further information on the Company's risk factors, please see the 10-K report filed with the Securities and Exchange Commission this afternoon. The earnings release and the slide prepared for this presentation. Joining us today from MannKind are Chief Executive Officer, Michael Castagna, and Chief Financial Officer, Steve Binder.

謹此提醒，本次電話會議於 2024 年 2 月 27 日進行錄音，電話會議結束後不久即可在 MannKind Corporation 網站上回放，直至 2024 年 3 月 12 日此電話會議將包含前瞻性陳述。此類前瞻性陳述存在風險和不確定性，可能導致實際結果與所陳述的預期有重大差異。有關公司風險因素的更多信息，請參閱今天下午向美國證券交易委員會提交的 10-K 報告。財報發布和為本次簡報準備的幻燈片。今天加入我們的有 MannKind 執行長 Michael Castagna 和財務長 Steve Binder。

I would now turn the conference over to Mr. Castagna. Please go ahead, sir.

我現在將會議交給卡斯塔尼亞先生。請繼續，先生。

Thank you, Valerie. We have never seen better time for mankind than we do today. As we look at our future is extremely exciting and then never more motivated to ensure we deliver on all key operational opportunities in front of us.

謝謝你，瓦萊麗。對人類來說，我們從未經歷過比今天更好的時代。當我們展望未來時，我們感到非常興奮，並且從未如此有動力確保我們實現我們面前的所有關鍵營運機會。

As we think about today, Steve and I will go over the operational pipeline highlights the financial review. I'm also here today with Lawrenceville as our Chief Operating Officer for Q&A, we will drive shareholder value by making a difference in the lives of the patients we serve, we will make over 25 million doses and devices in 2024 and helped roughly 25,000 patients take a MannKind produced product in 2023 most in our history.

當我們今天思考時，史蒂夫和我將回顧營運管道，並專注於財務審查。今天我也與勞倫斯維爾一起作為我們的首席營運官進行問答，我們將透過改變我們所服務的患者的生活來推動股東價值，我們將在2024 年生產超過2500 萬劑藥物和設備，並幫助大約25,000名患者以 MannKind 在 2023 年生產的歷史上最多的產品為例。

In Q4, we had record revenue for TVs on both royalty and collaboration manufacturing, along with record production on tablets or cartridges. We advanced our pipeline in both the orphan business as well as endocrine business. And our endocrine business had its second consecutive profitable quarter. We finished the year in the strongest position we have been in in terms of financial ability as well as by selling the TVs with 1% of our typical royalty for $150 million upfront and $50 million revenue milestone, many of you asked, could we have sold more?

第四季度，我們的電視版權費和合作製造收入均創紀錄，平板電腦或卡式錄音帶的產量也創紀錄。我們推進了孤兒藥業務和內分泌業務的研發管線。我們的內分泌業務連續第二季獲利。我們在財務能力方面處於有史以來最強勁的位置，並且透過以1.5 億美元的預付款和5000 萬美元的里程碑收入以我們典型的特許權使用費的1% 出售電視，你們很多人問，我們是否可以賣電視更多的？

Why did we sell more? And the reality is we didn't need to sell more if we wanted to make sure we were comfortable with carrying that level of debt and cash on the balance sheet to control our future. We're very excited about Tyvaso DPI and what it's going to bring to patients and anticipate hopefully positive milestones per ton based on the future and never wanted to preserve 90% of that value for our shareholders.

為什麼我們賣得更多？現實情況是，如果我們想確保我們能夠在資產負債表上承擔一定程度的債務和現金來控制我們的未來，那麼我們不需要出售更多產品。我們對 Tyvaso DPI 以及它將給患者帶來的東西感到非常興奮，並預計未來每噸將實現積極的里程碑，並且從未想過為我們的股東保留 90% 的價值。

At the same time, we wanted to derisk on the debt side of our Company, but also restructure insulin purchase commitment and reduced our near-term cash outlays about $50 million. The EBU will be the foundation for our future launches and currently makes up about 37% of our revenue in 2023. As I presented at JPMorgan in January, our ability to grow double digits for the foreseeable future looks bright. And you see in 2023, our total revenue approached $200 million, almost 100% growth year over year. I'm going to spend a few minutes on Afrezza and the EBU because we are at a pivotal inflection point for our future. Innovation takes time and disruption is even higher.

同時，我們希望降低公司債務方面的風險，同時重組胰島素採購承諾，並減少約 5,000 萬美元的近期現金支出。EBU 將成為我們未來推出產品的基礎，目前約占我們 2023 年營收的 37%。正如我一月份在摩根大通的演講中所言，我們在可預見的未來實現兩位數增長的能力看起來很光明。你看，到 2023 年，我們的總收入接近 2 億美元，比去年同期成長幾乎 100%。我將花幾分鐘時間討論 Afrezza 和 EBU，因為我們正處於未來的關鍵轉折點。創新需要時間，而顛覆則更需要時間。

When you think about the weight loss craze today, GLPs were 20 years in the making to what you see today, pods in type one diabetes, 10 years in the making. And pens took a huge time to convert from vials back in the early two thousands, I believe we can make this business a core pillar of our growth story. We look at the Endocrine business.

當你想到今天的減肥熱潮時，你會發現 GLP 花了 20 年的時間才變成你今天看到的，一型糖尿病的 pod 花了 10 年的時間。早在兩千年前，鋼筆就花了很長時間從小瓶轉變為鋼筆，我相信我們可以讓這項業務成為我們成長故事的核心支柱。我們關注內分泌業務。

It grew 32% year over year or $70 million '23 and greater than $20 million in Q4, the second quarter in a row profit profit contribution as well as on a run rate of $80 million. We've made a lot of changes in 2023 and delivered. Despite those changes, it set us up for a transformation once we see the new data from inhaled one and inhale three this year. As I look at the revenue, Afrezza, net revenue grew $12 million or 27% year over year. This is our largest jump in seven years and is the most we've seen driven by volume alone as opposed to price balanced by historical standards. Several clinical readouts in 2024 may expand our market potential and I'll talk about those in a minute.

23 年年增 32%，即 7,000 萬美元，第四季超過 2,000 萬美元，連續第二季利潤貢獻，運行率為 8,000 萬美元。我們在 2023 年做了很多改變並交付了。儘管發生了這些變化，但一旦我們看到今年吸入一號和吸入三號的新數據，我們就會進行轉變。當我查看 Afrezza 的收入時，淨收入同比增長了 1200 萬美元，即 27%。這是我們七年來最大的漲幅，也是我們所見過的僅由數量驅動的最大漲幅，而不是由歷史標準平衡的價格驅動的。2024 年的幾項臨床讀數可能會擴大我們的市場潛力，我將立即討論這些內容。

One of the questions I get is what is different this year than prior years. Our focus this year is incredibly different. We've been waiting for this moment where we had people money and data. Many times, we had two out of three, but not all three. Number one, we've got to maintain our persistence and Medicare and commercial to grow our base business and leverage the her $35 insulin co-pay that currently exist for Medicare and commercial insurance coverage, we know is the number one objection, number two, we optimize our sales force footprint here in January to build capabilities for the future growth. And what that means is we were able to reallocate some headcount to create key account managers, reimbursement specialists as well as virtual and in-person training across the country. We also have new insights from market research, which I'll share with you shortly that suggests that by executing effectively, we can increase prescriber adoption.

我收到的問題之一是今年與往年有何不同。我們今年的重點非常不同。我們一直在等待這一刻，我們擁有資金和數據。很多時候，我們有三分之二，但不是全部三者。第一，我們必須保持我們的堅持和醫療保險和商業，以發展我們的基礎業務，並利用她目前用於醫療保險和商業保險的35 美元胰島素自付費用，我們知道這是第一大反對，第二大，我們在一月份優化了我們的銷售團隊佈局，以培養未來成長的能力。這意味著我們能夠重新分配一些人員來創建大客戶經理、報銷專家以及在全國範圍內進行虛擬和現場培訓。我們也從市場研究中獲得了新的見解，我很快就會與您分享，這些見解表明，透過有效執行，我們可以提高處方者的採用率。

And finally, around data and education, we want to focus on KOL development, education at conferences and publications to elevate the support and awareness, especially among academic centers here, some new market research as we go forward called the emotional engagement mindset model, which is done by a company. We've deleveraged from market research. This shows a significant shift in perception by the various groups we tested with our new data. And you can see at baseline just unaided awareness of Afrezza will people's perceptions were in terms of unattractive, empathetic attracted her passionate and by exposing them to our core visual aid as well as some of some expectations of what in hell three data readout. You can see we shipped almost two thirds of our key key target audiences are attracted are passionate about our future. It's really important because the first time we can see this big of a ship and where we started, where we end up with the new data coming, people don't want slow acting Inphone world that moves as fast as we did. When I look at the future here on our studies and held three, and then how long I'll talk a few minutes about these. We have 60 U.S. sites and KOL sites like the Mayo Clinic to jobs and clinics, some of the foundations of that diabetes treatment in this country from a Hershey's, our top-tier fully to Hero and Health Re as a principal investigator and he has done a great job. Ensuring This trial is dosing properly and enrolling quickly. We have over 300 patients in both of these trials and most of them are on track to read out this year.

最後，圍繞著數據和教育，我們希望專注於KOL 的發展、會議和出版物的教育，以提高支持和意識，特別是在這裡的學術中心，我們將進行一些新的市場研究，稱為情感參與心態模型，該模型是一家公司做的。我們已經從市場研究中去槓桿化了。這顯示我們用新數據測試的各個群體的看法發生了重大轉變。你可以看到，在基線上，Afrezza 的無輔助意識將人們的感知視為沒有吸引力，同理心吸引了她的熱情，並透過讓他們接觸我們的核心視覺輔助以及對三個數據讀出的一些期望。您可以看到，我們交付的關鍵目標受眾中近三分之二都被吸引了，他們對我們的未來充滿熱情。這非常重要，因為當我們第一次看到這麼大的船時，我們從哪裡開始，從哪裡結束新數據的到來，人們不希望行動緩慢的智慧型手機世界像我們一樣發展得那麼快。當我展望未來在這裡對我們的學習和舉行的三場，然後多久我會講幾分鐘關於這些。我們有60 個美國網站和KOL 網站，例如梅奧診所(Mayo Clinic) 的工作和診所，以及這個國家糖尿病治療的一些基礎，從好時(Hershey's)、我們的頂級完全到Hero 和Health Re 作為首席研究員，他已經完成了乾得好。確保該試驗劑量正確並快速入組。我們在這兩項試驗中有超過 300 名患者，其中大多數都有望在今年讀出結果。

On the left side of the slide, type one, diabetes and health three is the largest switch study away from AID. pumps. We'll be about 120 some patients in this trial, and then we'll be on MDI. half of them will be likely on the pumps as we look at the data. The reason this data sets important is it's utilizing a new dosing conversion upfront to ensure proper efficacy is maintained or improved. They are also doing meal tolerance test at baseline and week 17. So we can see how people dosing may have changed over this timeframe.

幻燈片左側的第一型、糖尿病和健康三型是遠離愛滋病的最大轉變研究。泵。我們將有大約 120 名患者參與這項試驗，然後我們將使用 MDI。當我們查看數據時，其中一半可能會出現在泵上。該數據集之所以重要，是因為它預先利用了新的劑量轉換來確保維持或提高適當的功效。他們還在基線和第 17 週進行飲食耐受性測試。所以我們可以看到人們的劑量在這段時間內可能發生了怎樣的變化。

And another thing to remember about this trial is the first time we're enrolling almost 25% of the patients are level seven A1c when they enter. So we've also shown you hopefully, that tight control and remain by switching to receivable plus Afrezza Degludec is the generic name. A lot of people ask me what is the goal of inhaled three? Our goal is equal. Efficacy was perceived to be the standard of care, including a IV system no mealtime insulin or AID. systems ever be another system head to head. We think this is an important metric that is successful. And if we see a clinical advantage on highs or lows.

關於這項試驗需要記住的另一件事是，我們第一次招募了近 25% 的患者，他們在進入時的 A1c 水平為 7 級。因此，我們也希望向您展示，透過切換到應收款來保持嚴格控制，加上 Afrezza Degludec 是通用名稱。很多人問我吸三的目標是什麼？我們的目標是平等的。療效被認為是護理標準，包括靜脈注射系統、無餐時胰島素或輔助治療劑。系統永遠是另一個系統的正面對決。我們認為這是成功的一個重要指標。如果我們在高點或低點看到臨床優勢。

That's upside to our expectations.

這超出了我們的預期。

We also plan to use this data to hopefully update conversion figure one in our Afrezza label. We've been in discussions with the FDA since the start of the PEAKS program around how do we update that initial dose conversion?

我們也計劃使用這些數據來更新 Afrezza 標籤中的轉換率圖一。自從 PEAKS 計劃啟動以來，我們一直在與 FDA 討論如何更新初始劑量轉換？

We hope to inhale three will be part of that dataset on the right side of this slide, you can see sorry, on the bottom of the slide, the different data readouts. First dose will be ATTV. In March, the 17 week day, we expect to present at ADA in June and the 30 week data will be complete in Q3 and will be presented at a future conference on the right side of this slide, is inhaled once this is a pediatric study, and we think this is a watershed moment in order to transform the inflection of Afrezza will be through pediatrics. And we look at diabetes innovation today, whether CGM insulin pumps started with children and work their way into adults because the patients are worn social media, the parents are more progressive and the doctors are more progressive. This is the largest study done on a present over 10 years. And so far, we don't have the data, but I can tell you the conversion dose has appeared to drop to cause less dropouts relative to our original trials on Afrezza because also meal tolerance test at baseline using CGM. And hopefully the study will be used to secure pediatric approval in 2025 and beyond. This is how we believe we will accelerate rapid growth of Afrezza, and this will ultimately spill over into adults. One hangover is still the lungs, and we think it's time to move forward beyond this. And we look at the data today to build the market 10 years. We've helped tens of thousands of patients. We are building up U.S. KOL support. And we have this new data coming out will not be going to the children if we're worried about the safety of our products. So when I look at the future and the growth opportunity we look at for segments of our future. Number one, we're already approved for type one and type two adults in health, three will be using a new dosing with CGM and an upfront conversion for super excited about this data set as it also includes a head to head data.

我們希望吸入三個將成為這張投影片右側資料集的一部分，抱歉，您可以在投影片底部看到不同的資料讀數。第一劑是 ATTV。3 月，第17 週的一天，我們預計將在6 月的ADA 上展示，30 週的數據將在第三季完成，並將在這張投影片右側的未來會議上展示，一旦這是一項兒科研究，就會被吸入，我們認為這是一個分水嶺時刻，以便透過兒科來改變 Afrezza 的變化。我們專注於現今的糖尿病創新，CGM 胰島素幫浦是否從兒童開始，並逐漸進入成人，因為患者習慣社群媒體，父母更進步，醫生也更進步。這是近十年來最大規模的研究。到目前為止，我們還沒有數據，但我可以告訴你，與我們最初對 Afrezza 的試驗相比，轉換劑量似乎有所下降，導致退出人數減少，因為還使用 CGM 進行了基線飲食耐受性測試。希望這項研究能夠在 2025 年及以後獲得兒科批准。我們相信，透過這種方式，我們將加速 Afrezza 的快速成長，並最終波及成人。其中一個宿醉仍然是肺部，我們認為是時候超越這一點了。我們透過今天的數據來建立市場 10 年。我們已經幫助了數以萬計的患者。我們正在建立美國 KOL 的支持。如果我們擔心我們產品的安全性，我們將不會向兒童提供這些新數據。因此，當我展望未來和成長機會時，我們著眼於未來的各個部分。第一，我們已經批准用於健康的一類和二類成人，其中三類將使用新的 CGM 劑量和預先轉換，因為該數據集還包括頭對頭數據，因此對此數據集感到非常興奮。

I just mentioned GLPs will continue to be the bulk of the units there in type two diabetes are those patients will still need mealtime insulin, and we'll continue to promote Afrezza and video in that segment as our millions of people who require mealtime insulin over the coming years. However, in order to be a leader in type one, we need the data from inhale three to set us up for inhale one, which is the pediatric segment. It is when we do finally get that data. We know insulin pumps will be the indirect competition when it comes to a doctor a patient or the city making an educational decision for a patient. They want to know what Afrezza looks like against insulin pumps. We started that study within health rate.

我剛才提到，GLP 將繼續成為二型糖尿病治療的主要部分，因為這些患者仍然需要進餐時胰島素，我們將繼續在該領域推廣 Afrezza 和視頻，因為我們數百萬需要進餐時胰島素的人超過了未來幾年。然而，為了成為第一類領域的領導者，我們需要吸入三號的資料來為吸入一號（兒科細分市場）做好準備。這是我們最終獲得數據的時候。我們知道，當涉及醫生、患者或城市為患者做出教育決策時，胰島素幫浦將成為間接競爭。他們想知道 Afrezza 與胰島素幫浦相比會是什麼樣子。我們在健康率範圍內開始了這項研究。

We're excited to hopefully wrap up and have one and a few months here.

我們很高興能夠結束並在這裡度過幾個月。

Once we see that data, we will have a one-two punch this year as we wrap up 2024. And now as people are starting to see the first dose data, we're getting questions on gestational diabetes. We think there's an unmet need there that we want to fulfill over time because there's only two drugs that can be used today, net forming, which crosses the placenta and slow acting injectable insulin.

一旦我們看到這些數據，今年 2024 年即將結束時，我們將迎來一拳兩拳。現在，當人們開始看到第一批劑量數據時，我們收到了有關妊娠糖尿病的問題。我們認為，那裡有一個未滿足的需求，我們希望隨著時間的推移來滿足，因為目前只有兩種藥物可以使用，即穿過胎盤的淨形成藥物和慢效注射胰島素。

And for anyone that knows and suffer from gestational diabetes, keeping your time-in-range really tight is critically important. I'm going to bridge over to the pipeline very quickly. Ntm nontuberculous mycobacterium with our qualified women suspension. Some of you may it may not be aware, but one of the competing products in Phase three had a pause this week enrollment and people ask. Why am I excited about our program and why am I confident?

對於任何了解並患有妊娠糖尿病的人來說，嚴格控制時間範圍至關重要。我將很快橋接至管道。 Ntm 非結核分枝桿菌與我們合格的女性懸浮液。你們有些人可能不知道，第三階段的一款競爭產品本週暫停了招生，人們會問。為什麼我對我們的計劃感到興奮並且充滿信心？

Well, the reason we are excited is one when we purchased the product, it was preclinical data showing an improvement in bacterial recovery in the lung model that they use number two, there's wearable data. The product is approved today, indirectly through an medic market access program by the FDA and Novartis. So we see robust data being generated from patient taking capacity here in the US as well as Japan. Third, there's KOL support for this along with guidelines potentially. And finally, there's no near-term competition for trials now for patients as we look forward, we have 100 sites we're going to target across the world, and we see no other option really for these patients to roll besides the current drugs on the market hurricanes. So here's the design of our Phase three study called the ICON one study, which was designed post our FDA feedback along with the quality like group there at the FDA. We've taken their feedback within corporate dendritic design. That's 120 patients on the active arm and 60 on the placebo arm will do an interim analysis at 50%. And we'll continue to watch enrollments as we saw that the competing programmable route relatively quickly over the last six months of the year and last year into this year, and that gave us even more excitement for the speed of enrollment that could happen with this trial.

好吧，我們興奮的原因之一是，當我們購買該產品時，臨床前數據顯示他們使用的肺部模型中的細菌恢復有所改善，第二個是可穿戴數據。該產品今天透過 FDA 和諾華的醫療市場准入計畫間接獲得批准。因此，我們看到美國和日本的患者接收能力正在產生可靠的數據。第三，有 KOL 對此的支持以及潛在的指導方針。最後，正如我們所期望的那樣，目前對患者的試驗沒有近期的競爭，我們將在世界各地瞄準 100 個地點，除了目前的藥物之外，我們認為這些患者沒有其他選擇。市場颶風。這是我們的第三階段研究的設計，稱為 ICON one 研究，該研究是根據 FDA 的回饋以及 FDA 的品質小組的回饋而設計的。我們在企業樹突設計中聽取了他們的回饋。活性組的 120 名患者和安慰劑組的 60 名患者將以 50% 的比例進行中期分析。我們將繼續關注註冊情況，因為我們看到競爭的可編程路線在今年的最後六個月以及去年到今年的速度相對較快，這讓我們對可能發生的註冊速度感到更加興奮審判。

We're excited to get this trial going and we expect to file the IND here in March and kick off the trial in June as we've had a lot of dialogue with FDA on the trial design, and we expect quite quick approval on a central IRB.

我們很高興能夠進行這項試驗，我們預計將在 3 月在這裡提交 IND，並在 6 月開始試驗，因為我們已經與 FDA 就試驗設計進行了很多對話，我們預計很快就會獲得批准中央IRB 。

That's exciting to us that this will be over $1 billion market with only two players in the next 5 to 10 years. We have the potential to be the second approved NTM product in the market research indicates we will be a potentially preferred option for patients, whether it's because of our favorable safety profile relative to Orla CORAL cafes and units that's utilized for the toxicities and tolerability challenges that some people face with hurricanes. We also know that how convenient dosing, what does that mean? 28 days of treatment followed by two months, all fall by 28 days of treatment.

令我們興奮的是，在未來 5 到 10 年內，這個市場將超過 10 億美元，只有兩個參與者。我們有潛力成為第二個獲得批准的NTM 產品，市場研究表明我們將成為患者的潛在首選，無論是因為我們相對於Orla CORAL 咖啡館和單位的良好安全性，這些咖啡館和單位用於解決毒性和耐受性挑戰，有些人面臨颶風。我們也知道加藥有多方便，這代表什麼？28天治療後兩個月，均在28天治療後下降。

So if you're doing well, you'll potentially be treated four cycles a year. It gives patients a large burden back from what they did every single day.

因此，如果您表現良好，您可能每年會接受四個週期的治療。它給患者每天所做的事情帶來了極大的負擔。

So where they are, we also know the current treatments are not highly efficacious and that patients need more options in order to keep this disease and control. It may be disease that goes away and comes back over time, but it's one that they're popular with chronically for a long time. We have an opportunity to expand a brand within the brand as we think about capacity in the future.

因此，我們也知道目前的治療方法並不十分有效，患者需要更多的選擇來維持和控制這種疾病。這種疾病可能會隨著時間的推移而消失並復發，但這是他們長期流行的疾病。當我們考慮未來的產能時，我們有機會在品牌內擴展品牌。

Next quick pipeline highlight I want to talk about is idiopathic pulmonary fibrosis two oh one. This is going to be known as nintedanib GPI. as we go forward.

接下來快速管道重點我要講的是特發性肺纖維化兩個哦一個。這將被稱為尼達尼布 GPI。當我們前進時。

Reason I'm excited about this program is our 28 day tox data was very clean. We know 80% of these patients die at five years. There's a huge unmet need in this disease state and open the market leader from marketed by bundling on and we have decreased risk relative to the landscape that has failed in IPF development because we already know this molecule works in IPF. What we do also know that there's severe GI toxicities, which limits patient acceptance and uptake and prescriber adoption is roughly 15,000 active patients in treatment in this country. And we believe bringing a more tolerable product that could potentially be dosed higher, be maximized in value for this population relative to what's out there today.

我對這個計劃感到興奮的原因是我們的 28 天毒性數據非常乾淨。我們知道這些患者中有 80% 在五年內死亡。這種疾病狀態存在巨大的未滿足需求，透過捆綁銷售打開了市場領導者的市場，相對於 IPF 開發失敗的情況，我們降低了風險，因為我們已經知道這種分子在 IPF 中起作用。我們也知道，該國大約有 15,000 名活躍患者正在接受治療，存在嚴重的胃腸道毒性，這限制了患者的接受度和服用率以及處方者的採用。我們相信，相對於當今的產品，推出一種更耐受、劑量可能更高的產品，可以為該人群帶來最大的價值。

Additionally, our rat glioma study, a one appeared to mitigate inflammation and fibrosis comparable to oral the tentative at substantially lower dose as we go forward in our IND will be filed will be studying this into a one in our in our mix, but we'll be studying this in our Part one a single ascending dose as well as our multiple ascending dose to show can we tolerate higher doses over seven days. This will be an important study that gets done here in Q2 with data expected to read out Q3.

此外，我們的大鼠神經膠質瘤研究，一項似乎可以減輕發炎和纖維化，與口服相比，當我們在IND 中推進時，暫定劑量要低得多，將在我們的組合中研究這一點，但我們'我們將在第一部分中研究單次遞增劑量以及多次遞增劑量，以表明我們能否在 7 天內耐受更高的劑量。這將是一項重要的研究，將在第二季完成，數據預計將在第三季讀出。

Our goal is to show lower GI side effects in safety and healthy volunteers.

我們的目標是在安全和健康的志願者中顯示出較低的胃腸道副作用。

I want to acknowledge as we go forward, the hard work that Steve has done in lending, our royalty financing deal. As we work on this for over six months. We're in a great position because of these vision and leadership over the last seven years.

在我們前進的過程中，我想感謝史蒂夫在貸款和我們的特許權使用費融資交易方面所做的辛勤工作。我們為此工作了六個多月。由於過去七年的願景和領導力，我們處於有利地位。

Before I turn it over, I just want to acknowledge all the hard work Steve has done for us and our shareholders and our employees with that said, I'll turn it over to Steve to go over the financials for the quarter.

在我移交之前，我只想感謝史蒂夫為我們、我們的股東和員工所做的所有辛勤工作，也就是說，我將把它移交給史蒂夫來檢查本季度的財務狀況。

Thank you, Mike, and good afternoon. I'm pleased to review select Fourth Quarter and Full Year 2023 financial results. Please supplement this call by reading the consolidated financial statements and MD&A contained in our 10-K 2023 was a year of substantial revenue growth for the Company. In terms of both percentage and dollar growth, total revenues doubled versus 2022 and reached nearly $200 million. Let's break this down by starting with the fourth quarter total revenues. At the bottom of the table, our total revenues grew a robust 62% versus fourth quarter 2022 and 99% for the 2023, four year period, primarily due to the growth in our database ODPI. related revenue. Going back to the top of the table, you'll see that database or DPI royalty revenue for the fourth quarter was $21 million, which is 132% increase versus 2022. The result of continued growth in use of today's IDPI. for patients suffering from PAH and PHILD. Please note that $2.1 million of the fourth quarter royalty revenue was sold to a third party, and I will review the accounting for the royalty sale in a few slides.

謝謝你，麥克，下午好。我很高興查看 2023 年第四季和全年的部分財務表現。請閱讀我們 10-K 中包含的合併財務報表和 MD&A 來補充本次電話會議，2023 年是公司收入大幅增長的一年。從百分比和美元成長來看，總收入比 2022 年翻了一番，達到近 2 億美元。讓我們從第四季的總收入開始對此進行詳細分析。在表格底部，我們的總營收較 2022 年第四季強勁成長了 62%，2023 年四年期間成長了 99%，這主要是由於我們資料庫 ODPI 的成長。相關收入。回到表格頂部，您會看到第四季度的資料庫或 DPI 版稅收入為 2,100 萬美元，比 2022 年增長了 132%。這是當今 IDPI 使用量持續成長的結果。適用於患有 PAH 和 PHILD 的患者。請注意，第四季度特許權使用費收入中的 210 萬美元出售給了第三方，我將在幾張幻燈片中回顧特許權使用費銷售的會計處理。

Collaboration services, fourth quarter revenue was $17 million, which was an 81% increase over 2022 was primarily representative of strong pervasive DPF production volumes in the fourth quarter. For the full year 2023 Type ADPI. royalty revenue was $72 million, an increase of 361% versus 2022, which was primarily due to the increase in patient demand for the product and the start of commercial sales by United Therapeutics late in the second quarter of 2022. Royalty revenue has now become our largest single source of revenue, which allows us to fund and progress our clinical development and product pipeline, collaboration and services revenue for the 2023 full year period was $53 million, an increase of 90% versus 2022, which is primarily due to the start of commercial manufacturing in the second quarter of 2022. And the increase in production and sales of Type ACEPI. semi-finished product United Therapeutics in 2023.

協作服務，第四季營收為 1,700 萬美元，比 2022 年成長 81%，主要代表第四季 DPF 產量強勁。對於 2023 年全年，請輸入 ADPI。特許權使用費收入為 7,200 萬美元，比 2022 年增長 361%，這主要是由於患者對該產品的需求增加以及 United Therapeutics 在 2022 年第二季末開始商業銷售。特許權使用費收入現已成為我們最大的單一收入來源，這使我們能夠資助和推進我們的臨床開發和產品管道，2023 年全年合作和服務收入為 5300 萬美元，比 2022 年增長 90%，主要是由於商業製造於2022 年第二季開始。以及ACEPI型產量和銷售量的增加。 2023 年聯合療法半成品。

Moving down the table to our endocrine business, total endocrine revenues were $20 million for the fourth quarter and $74 million for the full year. For the fourth quarter, Afrezza net revenue of $15 million compared to $12 million in 2022, a growth rate of 29%, which was mainly driven by a higher patient demand with underlying paid TRx growth of 29% year over year, a lower gross to net deduction as a percentage of gross revenue and price compared to the third quarter of 2023. It was a $2 million increase, which represents half patient demand and have increased channel inventory due to wholesalers purchasing an extra week of product in late December. This additional wholesaler purchase in late December would likely impact our net revenues for the first quarter of 2024.

再看看我們的內分泌業務，第四季內分泌總收入為 2000 萬美元，全年內分泌總收入為 7,400 萬美元。第四季度，Afrezza 淨收入為 1500 萬美元，而 2022 年為 1200 萬美元，增長率為 29%，這主要是由於患者需求增加，基礎付費 TRx 同比增長 29%，總收入較低與2023 年第三季相比，淨扣除額佔總收入和價格的百分比。增加了 200 萬美元，相當於患者需求的一半，並且由於批發商在 12 月底額外購買了一周的產品，因此增加了渠道庫存。12 月底批發商的額外採購可能會影響我們 2024 年第一季的淨收入。

For the full year 2023 period, 27% increase in Afrezza net revenue was mainly related to increased volume from higher patient demand with underlying paid TRx growth of 25%. Price and a more favorable gross-to-net adjustment. As a percentage of gross revenues, net revenue for V-Go was $5 million. In the fourth quarter of 2023, revenues were 13% lower versus 2022, primarily due to lower patient demand and higher gross to net as a percentage of gross revenues, partially offset by price V-Go net revenue improved versus the third quarter of 2023 by $0.2 million, mainly due to improved gross to nets for the full year period to 48% increase is primarily related to the purchase of V-Go on May 31 of 2022, reflecting a seven month versus 12 months comparative.

2023 年全年，Afrezza 淨收入成長 27%，主要與病患需求增加帶來的銷售增加有關，基礎付費 TRx 成長 25%。價格和更有利的毛淨調整。V-Go 的淨收入佔總收入的百分比為 500 萬美元。2023 年第四季的收入比2022 年下降了13%，主要是由於患者需求下降以及毛淨收入佔總收入的百分比上升，部分被價格抵消。與2023 年第三季度相比，V-Go 淨收入提高了20 萬美元，主要是由於全年總淨值增長 48%，這主要與 2022 年 5 月 31 日購買 V-Go 有關，反映了 7 個月與 12 個月的比較。

Next slide shows our revenue growth by source and basic earnings per share on a quarter by quarter basis in the first quarter of 2022 through the fourth quarter of 2023. Like to show this graph because it highlights how dramatically our business has changed in two years and how we are executing and expectations for the fourth quarter 2023, total revenues increased 14% sequentially versus the third quarter of '23 and are up 62% versus the fourth quarter of 2022. Fourth quarter 2023 total revenue of $58 million was almost five times the total revenues recorded in the first quarter of 2022 below the graph of our quarterly basic earnings and loss per share.

下一張投影片顯示了 2022 年第一季至 2023 年第四季我們按來源劃分的收入成長和按季度計算的基本每股收益。喜歡展示這張圖表，因為它突顯了我們的業務在兩年內發生了多麼巨大的變化，以及我們的執行情況和對2023 年第四季度的預期，總收入比2023 年第三季度連續增長了14 %，比2023 年第三季成長了62% 2022 年第四季。2023 年第四季的總收入為 5,800 萬美元，幾乎是 2022 年第一季記錄的總收入的五倍，低於我們季度基本每股收益和虧損的圖表。

The fourth quarter was the second straight quarter with net income and positive earnings per share. As I stated on the third quarter earnings call, we are in a period we expect to bounce back and forth between earnings and loss per share as our revenues increase. But we will also be increasing our spending on our pipeline as we move MNKD-101 into a Phase 3 global clinical trials and MNKD-201 into a Phase 1 clinical trial. In addition, we will wait to see the results from the in-house three and then have one clinical trials for Afrezza before deciding whether to increase promotional spend behind that product. For now, we will continue to focus on growing the profitability of the endocrine business unit which has had a positive contribution for two straight quarters.

第四季是連續第二季淨利和每股收益為正。正如我在第三季財報電話會議上所說，隨著我們收入的增加，我們預計將在每股收益和虧損之間來回反彈。但隨著我們將 MNKD-101 進入 3 期全球臨床試驗，並將 MNKD-201 進入 1 期臨床試驗，我們也將增加在管道上的支出。此外，我們將等待看到內部三項研究的結果，然後對 Afrezza 進行一項臨床試驗，然後再決定是否增加該產品的促銷支出。目前，我們將繼續專注於提高內分泌業務部門的獲利能力，該業務部門已連續兩個季度做出了積極貢獻。

Moving on to our GAAP to non-GAAP reconciliation, I'll first focus on the fourth quarter, which is on the left hand side of the table, we had GAAP net income of $1 million, which when adjusted for select noncash items for stock compensation gain or loss on foreign currency transactions, which is related to our insulin purchase commitment loss on available for sale securities was sold portion of the royalty revenue and the interest expense on the liability for sale of future revenues, which I'll discuss in more details in a minute, provide for a non-GAAP net income of $7 million versus a 2022 fourth quarter non-GAAP net loss of $11 million for the full year 2023 period, we ended with a net loss of $12 million when adjusted for the select noncash items becomes non-GAAP, net income was $6 million, which is compared to a non-GAAP net loss of $78 million in 2022 and $84 million year on year positive change.

繼續我們的 GAAP 與非 GAAP 調節，我首先關注第四季度，即表格左側，我們的 GAAP 淨利潤為 100 萬美元，根據股票的選定非現金項目進行調整外幣交易的補償收益或損失，這與我們的胰島素購買承諾有關，可供出售證券的損失被出售，特許權使用費收入的一部分以及未來收入出售負債的利息費用，我將在更多內容中討論詳細信息一分鐘後，考慮到非GAAP 淨利潤為700 萬美元，而2022 年第四季非GAAP 淨虧損為1,100 萬美元，2023 年全年，我們最終的淨虧損為1,200 萬美元，根據選擇調整後非現金項目變為非GAAP 時，淨利潤為600 萬美元，而2022 年非GAAP 淨虧損為7,800 萬美元，年比正變動為8,400 萬美元。

Now I'd like to take some time to explain the accounting that resulted from the sale of our 1% of our TV show DPI. royalty to set the stage, we saw 1% of our 10% royalty for $150 million, plus up to $50 million. More of certain net revenue numbers are retained within a period of time ending of September 2027. This puts a third party valuation on the 10% royalty of approximately $1.5 billion to $2 billion. After we announced the work the sale in early January, I heard back from investors that we could have done a better job explaining how we recognize this transactions in our financial statements and how we got to our accounting conclusions.

現在我想花一些時間解釋一下出售我們電視節目 DPI 1% 的股份所產生的會計結果。為了奠定基礎，我們將 10% 的特許權使用費中的 1% 支付為 1.5 億美元，再加上高達 5,000 萬美元。更多特定淨收入資料保留在截至 2027 年 9 月的一段時間內。這使得第三方對 10% 特許權使用費的估值約為 15 億至 20 億美元。在我們一月初宣佈出售工作後，我從投資者那裡得到反饋，我們本可以更好地解釋我們如何在財務報表中確認這筆交易以及我們如何得出會計結論。

So let me try again first, we looked at all of the GAAP guidance reviewed all similar relevant transactions we could find in the last five years and they consulted with our auditors. The conclusion we arrived at amongst other things is that mankind has a continuing involvement in the generation of high base of DPR revenue through activities to protect the intellectual property of pervasive DPI. such as defending the patent estate, protecting the product and the continuing involvement in the manufacturing, the product for United Therapeutics. Thus, the upfront proceeds recorded as a liability for future sales of royalties, not as revenue. The table on the slide reflects how the accounting works. We record the cash consideration received net of issuance costs and the related liabilities for the sale of future royalties on our balance sheet to recognize interest expense related to liabilities with forecasted future royalties to be received through 2042 and calculate the return that would be needed when receiving a $150 million upfront payment for 1% of the royalty over this time period. This rate came to just over 11% in future periods, we'll continue to estimate the future royalty stream based on royalty trends, commercial success of Type ACDPI., competition for the brand and other meaningful inputs. The outcome of these future estimates may adjust the prospective interest rate used in determining interest expense and amortization of liability. Each quarter, we will charge our P&L for non-cash interest expense based on the interest rate and credit the liability. We also recognize 1% royalty as non-cash revenue and reduced the liability by this amount. In addition to the noncash attributes of this transaction, we also earn cash interest income of approximately $7.5 million annually. This slide shows how the accounting should work for 2024. If nothing changes in our forecast of expected royalties. The balance sheet would end 2024 with $153 million in cash and $153 million of a liability for the sale of future royalties. The liability balance will increase as long as the non-cash interest expense is greater than the non-cash royalty revenue, which is likely to occur over the next few years once the noncash royalty revenue becomes greater than the non-cash interest expense, assuming that sales of today's IDPI. continue to grow, then the liability balance will begin to decrease focusing on the 2024 income statement. On the right side of the table, we will record non-cash revenue of $10 million and cash interest income of $7 million, offset by non-cash interest expense of $17 million.

因此，讓我先再試一次，我們查看了所有 GAAP 指南，審查了我們在過去五年中可以找到的所有類似相關交易，並諮詢了我們的審計師。除此之外，我們得出的結論是，人類透過保護普遍 DPI 智慧財產權的活動，持續參與 DPR 收入的高基礎的產生。例如捍衛專利權、保護產品、繼續參與 United Therapeutics 產品的製造。因此，預付款記錄為未來特許權使用費銷售的負債，而不是收入。投影片上的表格反映了會計的運作方式。我們在資產負債表上記錄扣除發行成本後收到的現金對價以及出售未來特許權使用費的相關負債，以確認與預計到2042 年將收到的未來特許權使用費負債相關的利息支出，並計算收到時所需的回報在此期間預付 1.5 億美元的特許權使用費。在未來的時期內，這一比率將超過 11%，我們將繼續根據版稅趨勢、ACDPI 類型的商業成功、品牌競爭和其他有意義的投入來估計未來的版稅流。這些未來估計的結果可能會調整用於確定利息費用和負債攤銷的預期利率。每個季度，我們將根據利率計入損益表中的非現金利息費用並貸記負債。我們也將 1% 的特許權使用費確認為非現金收入，並減少了這筆金額的負債。除了本次交易的非現金屬性外，我們每年還賺取約 750 萬美元的現金利息收入。這張投影片顯示了 2024 年的會計工作該如何進行。如果我們對預期特許權使用費的預測沒有任何變化。截至 2024 年，資產負債表上將有 1.53 億美元現金和 1.53 億美元用於出售未來特許權使用費的負債。只要非現金利息支出大於非現金特許權使用費收入，負債餘額就會增加，一旦非現金特許權使用費收入大於非現金利息支出，這種情況很可能在未來幾年發生，假設即今天的IDPI銷量。繼續成長，那麼負債餘額將開始減少，並專注於2024年損益表。在表格右側，我們將記錄 1000 萬美元的非現金收入和 700 萬美元的現金利息收入，被 1700 萬美元的非現金利息支出所抵銷。

As discussed on a previous slide, we expect to isolate the non-cash aspects of this transaction and our quarterly GAAP to non-GAAP reconciliation of net income and loss with over $300 million of cash and investments on our balance sheet as of December 31, 2023, I want to share our near term priorities for using the cash to increase shareholder value.

正如上一張投影片中所討論的，我們預計將本次交易的非現金方面以及我們的季度GAAP 與非GAAP 淨利潤和虧損調節表分開，截至12 月31 日，我們的資產負債表上有超過3 億美元的現金和投資， 2023 年，我想分享我們利用現金增加股東價值的近期優先事項。

First, focusing on our development pipeline, we expect to fund much of MNKD-101 and MNKD-201clinical trial expense over the next few years through operating cash flow. As these assets advance through clinical trials, we will prioritize their funding. In addition to MNKD. one or one and two a one. We have two clinical trials for Afresa nearing data readout. We will wait to see the results of these trials before deciding whether to invest more behind this asset to grow revenues.

首先，重點關注我們的開發管線，我們預計未來幾年將透過營運現金流為 MNKD-101 和 MNKD-201 臨床試驗費用提供大部分資金。隨著這些資產通過臨床試驗的進展，我們將優先考慮它們的資金。除了MNKD。一或一，二一。我們有兩項 Afresa 臨床試驗即將讀出數據。我們將等待看到這些試驗的結果，然後再決定是否對該資產進行更多投資以增加收入。

In addition, we plan to do the following with our debt. Our MidCap senior secured debt has a balance of approximately $33 million as of December 31, 2023, and currently carries an interest rate of 8.25%. We expect to pay off this debt in the first half of 2024 to take advantage of the interest rate arbitrage between debt, interest expense and cash investment returns. And we lease our assets for mid-caps security interest Mann convertible debt with a balance of approximately $9 million as of December 31, 2023 is expected to be paid off early in cash or at a mix of cash and stock. By doing this, we will be we would be reducing future shareholder dilution. Our senior convertible debt with a balance of $230 million as of December 31, 2023 carries a low fixed interest rate of 2.5%, and we did not expect to buy back bonds prior to maturity in March 2026 maturity arrives. We expect to reduce future dilution by paying off the debt with cash by stock prices below the conversion price of $5.21. Additionally, we did not expect to access the ATM.

此外，我們計劃對債務採取以下行動。截至 2023 年 12 月 31 日，我們的中型股優先擔保債務餘額約為 3,300 萬美元，目前利率為 8.25%。我們預計將在 2024 年上半年償還這筆債務，以利用債務、利息支出和現金投資回報之間的利率套利。截至 2023 年 12 月 31 日，我們租賃資產用於中型擔保權益曼恩可轉換債務，餘額約為 900 萬美元，預計將以現金或現金與股票混合的方式提前償還。透過這樣做，我們將減少未來的股東稀釋。截至2023年12月31日，我們的優先可轉換債券餘額為2.3億美元，固定利率較低，為2.5%，我們預計不會在2026年3月到期前回購債券。我們預計，透過股價低於 5.21 美元的轉換價，以現金償還債務，從而減少未來的稀釋。此外，我們沒想到會使用自動櫃員機。

To summarize a very successful 2023, we doubled our total revenues to almost $200 million versus the prior year fourth quarter was a second successive quarter for positive contribution from our endocrine business unit. Q4 was the second successive quarter of net income for the Company. We saw the worst and interest in our 10% time-based IDPI. royalty, which values the royalty stream alone at between $1.5 billion and $2 billion. And we ended 2023 with $302 million in cash and investments. 2024 should be another stellar year for MannKind as we are financially trying to drive our commercial and clinical priorities and deliver increased shareholder value.

總結一下非常成功的 2023 年，我們的總收入比去年同期翻了一番，達到近 2 億美元。第四季是內分泌業務部門連續第二季做出的積極貢獻。第四季是公司連續第二季實現淨利。我們看到了最糟糕的情況，並對 10% 基於時間的 IDPI 產生了興趣。特許權使用費，僅特許權使用費流的價值就在 15 億至 20 億美元之間。截至 2023 年，我們擁有 3.02 億美元的現金和投資。2024 年對 MannKind 來說應該是另一個輝煌的一年，因為我們正在財務上努力推動我們的商業和臨床優先事項並增加股東價值。

Thank you, and now I'll turn it back over to Mike.

謝謝你，現在我會把它轉回給麥克。

Thank you, Steve.

謝謝你，史蒂夫。

I appreciate the explanation of the accounting. I never want to know that I appreciate you So next slide.

我很欣賞會計的解釋。我從來不想知道我很欣賞你所以下一張投影片。

So MannKind has been around 33 years. I want to give a special thank you to our founder who passed away eight years ago to on February 25, the reason that's important today, I decided to join MannKind and our forever be grateful for our man. He was a special human being who cared about society, our patients and making a difference. We have the foundation he left us within 2016.

MannKind 已經有 33 年左右的歷史了。我要特別感謝我們的創辦人，他於八年前於 2 月 25 日去世，這對我今天很重要，我決定加入 MannKind，我們永遠感激我們的創辦人。他是一個特別的人，關心社會、我們的病人並做出改變。我們擁有他在 2016 年離開我們的基金會。

Can we build this into a major self-sustaining growth company against the law? When you look at the history from 16 forward, we announced our United Therapeutics collaboration. We acquired Coram, which in our Phase three asset with qualifies me to MannKind one-on-one. We purchased V-Go, which made our endocrine division more sustainable and brought a couple of thousand new prescribers and Tyvaso DPI has been ahead of all expectations since its approval. As I look forward, we are just getting started expected 2024 milestones alone between Afresa and the study readout. Mannkind one-to-one MannKind to I want not to mention the case of DPI., which has two major trials going on to Tom, wanted to turn to what triggered this.

我們能否將其打造成一家違法的、能夠自我維持的大型成長型公司？當你回顧 16 年以來的歷史時，我們宣布了與 United Therapeutics 的合作。我們收購了 Coram，這在我們的第三階段資產中使我有資格參加 MannKind 一對一。我們購買了 V-Go，這使我們的內分泌部門更具可持續性，並帶來了數千名新處方者，而 Tyvaso DPI 自獲得批准以來一直超出了所有人的預期。正如我所期待的，我們剛開始實現 Afresa 和研究讀數之間的 2024 年預期里程碑。Mannkind 一對一 MannKind 與我不想提及 DPI 的案例，該案例對 Tom 正在進行兩項重大審判，想要探討觸發此事件的原因。

This week were 70% enrolled.

本周有 70% 的學生入學。

Once they finish up enrollment will have 12 months there.

一旦他們完成註冊，將有 12 個月的時間。

We should expect to see data from United Therapeutics.

我們應該期待看到聯合治療公司的數據。

Additionally, our team just this year, they completed the high-speed fill finish line in terms of a qualification. I will now be going into PP. two, hopefully producing much higher lines of Tyvaso well, that line as we exit Q1 going into Q2.

另外，我們的團隊今年剛完成了高速灌裝終點線的資格認證。我現在要進入 PP。兩個，希望能生產出更高的 Tyvaso 生產線，當我們退出第一季進入第二季時，這條生產線。

As I look at our future, we have several key value drivers.

當我展望我們的未來時，我們有幾個關鍵的價值驅動因素。

As you can see, our insiders picked up some stock in the last few weeks post our Board meeting because we believe we're undervalued and we're very confident in our future analysts have expenses in for our pipeline, but no revenue in the next five years. We think this is an unfair valuation of our Company, given that we do expect to launch capacity in the next five years and move and TM I'm sorry, I moved to the IPF asset in terms of MannKind to a one in two patients and then hopefully into Phase 3 by then we go back and look at another successful company in time. Intermune for certainly valued at $800 million. One point in 18 months later was $8 billion once they got a positive data readout. Our job is to not react or overreact day-to-day to swings in the stock market, but to lay out a firm foundation for future growth. And as we look out there, whether it's the pipeline with MannKind one-to-one, every thousand patients is approximately $100 million in revenue to a one we're going to start patients those nurse think about IPF every thousand patients was roughly $150 million in annual revenue. And then we get into TVs or DPI., which as you can see this past year was when you add up the collaboration services revenue and additions that have royalties, we do have those roughly 5,000 patients on Tyvaso DPI, and that's about half of the $250 million revenue that we experienced this past year and the endocrine side, we have several major upcoming opportunities within health one and then held three as well as Afrezza international V-Go is being managed for improved profitability as we continue to focus on improving our margins by reducing COGS as well as improving gross-to-net. As we take a step back, we have multiple shots on goal to create significant shareholder value across three commercial products. When you think about Afrezza of SIDPI. V-Go, they're already FDA approved as well as two assets coming up quickly in the pipeline between MannKind one oh one into oh one, we have multiple shots on goal within these assets.

正如您所看到的，我們的內部人士在董事會會議後的最後幾週購買了一些股票，因為我們認為我們被低估了，並且我們對未來的分析師對我們的管道有支出非常有信心，但接下來沒有收入5年。我們認為這是對我們公司的不公平估值，因為我們確實預計在未來五年內啟動產能並轉移，TM 很抱歉，我將 MannKind 的 IPF 資產轉移到了二分之一的患者，並且然後希望進入第三階段，那時我們會及時回頭看看另一家成功的公司。Interune 的估值肯定高達 8 億美元。18 個月後，一旦他們得到積極的數據讀數，就達到了 80 億美元。我們的工作不是對股市的日常波動做出反應或過度反應，而是為未來的成長奠定堅實的基礎。正如我們所看到的，無論是與 MannKind 一對一的管道，每千名患者的收入約為 1 億美元，而我們將要為那些護士考慮 IPF 的患者提供的收入約為 1.5 億美元在年收入中。然後我們進入電視或DPI。正如您在過去一年中看到的那樣，當您將協作服務收入和包含特許權使用費的附加費用加起來時，我們確實有大約5,000 名患者使用Tyvaso DPI，這大約是全部患者的一半去年我們經歷了2.5 億美元的收入，在內分泌方面，我們在健康方面有幾個即將到來的重大機會，然後舉行了三個，以及Afrezza 國際V-Go 正在管理以提高盈利能力，因為我們繼續專注於提高利潤率透過降低銷貨成本以及提高毛淨值。當我們退後一步時，我們有多個目標，即透過三種商業產品創造顯著的股東價值。當你想到 SIDPI 的 Afrezza 時。 V-Go，它們已經獲得 FDA 批准，而 MannKind 一對一之間的管道中很快就會出現兩種資產，我們在這些資產中多次射門。

We are completely focused on delivering shareholder value sustainably for years to come.

我們完全專注於在未來幾年可持續地為股東創造價值。

We have several upcoming presentations and engagements at conferences.

我們即將在會議上進行幾場演講和活動。

I'll be doing non-deal roadshows with Steve over the coming months to get the word out as we feel like mankind as at the best inflection point with the best team in the industry, cash in the balance sheet and multiple shots on goal in terms of data readouts to drive future growth.

在接下來的幾個月裡，我將與史蒂夫一起進行非交易路演，以傳達訊息，因為我們感覺人類正處於最佳拐點，擁有業內最好的團隊，資產負債表中有現金，並且多次射門資料讀取方面推動未來成長。

We're super excited about our future, and I will stop there and are ready to take questions.

我們對我們的未來感到非常興奮，我將就此停止並準備好回答問題。

Thank you again.

再次感謝你。

(Operator instructions) Andreas Argyrides, Wedbush.

（操作員指示）Andreas Argyrides，Wedbush。

Great.

偉大的。

Thanks for taking our question. Congrats on all the progress on just the maybe two for us here quickly, despite an evolving competitive landscape in PAH and ILD. Sagard royalty puts a $15 billion valuation on TIBCO GPI., a key component to DPI.'s advantage, the ease and convenience of a low resistance advice compared with other high resistance devices.

感謝您提出我們的問題。儘管 PAH 和 ILD 的競爭格局不斷變化，但還是對我們在這兩個方面的所有進展表示祝賀。Sagard 版稅對 TIBCO GPI 的估值為 150 億美元，這是 DPI 優勢的關鍵組成部分，即與其他高電阻設備相比，低電阻建議的簡單性和便利性。

So the question is, could you elaborate on the differences with the DPI. device compare with the competitors and how that plays into DPI. safety and efficacy profile? And also, how do you see the DPI device playing a key role in the delivery of nintedanib in IPF Thanks, Andreas.

那麼問題來了，您能詳細說明一下與 DPI 的差異嗎？設備與競爭對手的比較以及它如何影響 DPI。安全性和有效性概況？另外，您如何看待 DPI 設備在 IPF 中尼達尼布輸送中發揮的關鍵作用？謝謝，Andreas。

I wish I could a second question. Can you repeat that one?

我希望我能問第二個問題。你能重複一下嗎？

Yes, sure. So go back to the advantages of the DPI. device. How do you see it playing a key role in the delivery of nintedanib and IPF or mostly from a delivery and a safety perspective?

是的，當然。那麼回到DPI的優點。裝置.您如何看待它在尼達尼布和 IPF 的輸送中發揮的關鍵作用，或者主要從輸送和安全的角度來看？

Yes.

是的。

No, I think that's what gets us excited raises. I followed that question. First is when you think about our platform, it's the same device being used in the same audience that we're currently moving forward, an orphan lung disease that United Therapeutics is also using, right?

不，我認為這就是讓我們興奮的加薪原因。我追問了這個問題。首先，當你想到我們的平台時，你會發現，我們目前正在推進的同一受眾群體中使用的設備是與聯合治療公司也在使用的孤兒肺病相同的設備，對嗎？

So the familiarity of the training, all that and the comfort of bringing inhalation into this patient population with our current technology gives us that much more confident because most of the powder is our novel excipient FDKP. So if they can tolerate that in the PH market and we know some of those patients overlap with ILD. as well as IPF. That then being able to show that our powder at 99% FDKP. should be able to on tolerated in the inattentive as we go forward. And so far, the animals, single-visit dissolution and all that looks positive. We're doing a chronic tox, and we'll have that done by the end of this year. At the same time, we get Phase one. So I think this year, but then it should feel like it's even more diverse than it already has given us an own asset and a known technology, and that will be a positive contribution for there.

因此，對培訓的熟悉度、所有這些以及使用我們當前的技術將吸入引入患者群體的舒適感讓我們更加自信，因為大部分粉末都是我們的新型賦形劑 FDKP。因此，如果他們能夠容忍 PH 市場上的這種情況，我們知道其中一些患者與 ILD 重疊。以及IPF。然後能夠表明我們的粉末 FDKP 為 99%。當我們前進時，應該能夠容忍不專心。到目前為止，動物、單次溶解以及所有看起來都是正面的。我們正在進行一項慢性毒理學工作，我們將在今年年底前完成。同時，我們進入了第一階段。所以我認為今年，但那時應該感覺它比它已經為我們帶來的自己的資產和已知的技術更加多樣化，這將是一個積極的貢獻。

On the other side of the equation, you're asking me how do we differentiate our platform I think, you know, our powders are built to fly with our devices. They're going hand-in-hand.

另一方面，你問我如何使我們的平台與眾不同，我認為，你知道，我們的粉末是為了與我們的設備一起飛行而設計的。他們將攜手並進。

We're not taking it a novel powder and thrown into an off-the-shelf device.

我們不會將其作為一種新穎的粉末放入現成的設備中。

I think that it's about that deep lung penetration.

我認為這與肺部的深度滲透有關。

It's about the velocity of those patterns are coming out and how consistent and deep lung penetration you're getting across the lung, the bed.

這與這些模式出現的速度以及你穿過肺部、床的肺部滲透的一致性和深度有關。

And so I think that's number one.

所以我認為這是第一名。

Number two, we know that the powder we need is very low because we've prior prior payable records of filling the smallest volume for the 60 microgram always the 64 microgram or higher. So as people want more, they don't need to inhale that much more powder to get additional effect size, which should help on cost. But should help on resorption as well as just safety. When you think about and a lot of FDA questions on hormones and devices and asthma, how to use steroid use these are questions that come up with the FDA. And it's really important, right that there's not excess powder come around, especially when you get to these narrow therapeutic drug and you want the proper dose delivered with minimal powder containment on happening. It will cover exhibit X extraction happening outside of the cartridge itself.

第二，我們知道我們需要的粉末非常低，因為我們之前有填充 60 微克的最小體積的應付記錄，總是 64 微克或更高。因此，當人們想要更多時，他們不需要吸入更多的粉末來獲得額外的效果，這應該有助於降低成本。但應該有助於吸收以及安全性。當你想到 FDA 提出的許多關於荷爾蒙、裝置和氣喘的問題時​​，如何使用類固醇，這些都是 FDA 提出的問題。非常重要的是，不要有多餘的粉末，特別是當您使用這些狹窄的治療藥物並且您希望以最小的粉末含量提供適當的劑量時。它將涵蓋發生在墨盒本身外部的 X 展品提取。

These are all important things that come up.

這些都是重要的事情。

And I also think patient satisfaction is very high in the trial that UTi ran phone and Pivotal and us. We also know from thousands of patients we've studied Afrezza in the device is relatively easy to use from four years old to profit 80 years old. And so those are just the well-known comfort, the dosing and the consistency of those will be important factors as we go forward.

我還認為，在 UTi 運行電話和 Pivotal 和我們的試驗中，患者滿意度非常高。我們也從我們研究的數千名患者中了解到，Afrezza 設備相對容易從 4 歲到 80 歲使用。因此，這些只是眾所周知的舒適度，劑量和一致性將是我們前進的重要因素。

I appreciate that.

我很感激。

I'll jump back into queue and congrats also on all the progress.

我將跳回隊列並祝賀所有的進展。

Thank you. one moment, please.

謝謝。稍等一會兒。

Our next question comes from the line of Olivia Breyer of Cantor Fitzgerald. Your line is open.

我們的下一個問題來自康托·菲茨杰拉德（Cantor Fitzgerald）的奧利維亞·布雷耶（Olivia Breyer）。您的線路已開通。

Hey, good afternoon, guys. Thank you for the question. Can you talk about how NTM fits into your strategic priorities just as you grow into a more mature company and there is some competition in the space, although maybe less of these days, as you pointed out. So how should we be thinking about where MNKD. one oh one could fit into the treatment paradigm. And last question is just can you remind us on what the timelines are for expected enrollment and data readouts there. Thank you.

嘿，下午好，夥計們。感謝你的提問。您能否談談當您成長為一家更成熟的公司時，NTM 如何適應您的策略重點，並且該領域存在一些競爭，儘管正如您所指出的，儘管現在可能競爭較少。那我們該如何思考MNKD。一對一可以融入治療範式。最後一個問題是，您能否提醒我們預期註冊和資料讀出的時間表。謝謝。

Sure, but I think there's a couple of things that help fits in the company. The first will be a decision on licensing outside the US, so we'll run the trial in key countries where NTM exists, but we may choose to partner out Japan, for example, where we saw in demand went independent and we have made those decisions. We don't have to make those decisions. We aren't looking for partners talking to partners, but it's up to us, and we're a little bit in control of that process there in terms of how it fits.

當然可以，但我認為有幾件事有助於融入公司。第一個將是在美國境外進行許可的決定，因此我們將在存在 NTM 的主要國家進行試驗，但我們可能會選擇與日本合作，例如，我們看到需求獨立的地方，我們已經做了這些決定。我們不必做出這些決定。我們並不是在尋找與合作夥伴交談的合作夥伴，但這取決於我們，我們在某種程度上控制了流程的適合程度。

In the meantime, I think there's core capabilities that we have today around reimbursement support, patient training and how do you treat Specialty Products and Distribution, things like that that we have that will be applicable to the NTM space.

同時，我認為我們今天擁有的核心能力涉及報銷支援、患者培訓以及如何對待專業產品和分銷，我們擁有的這些能力將適用於 NTM 領域。

And then when you think about where it fits into the treatment regimen, there's two points there. Number one, we're going after the refractory patients first. And in that population, right?

然後當你考慮它在治療方案中的位置時，有兩點。第一，我們首先要治療難治性患者。在那個人群中，對嗎？

The only drug approved is our case. And we think there we have a significant clinical advantage as well as the convenience advantage that we should build displaced or grow that market opportunity very quickly as we enter it on.

唯一獲得批准的藥物是我們的案例。我們認為，我們在這方面擁有顯著的臨床優勢以及便利優勢，當我們進入這個市場時，我們應該很快建立替代或擴大該市場機會。

The other part is we are actively working on a dry powder version of clofarabine. And we expect that that will be used for naive population, so that can be used earlier lines of treatment.

另一部分是我們正在積極開發氯法拉濱的乾粉版本。我們預計這將用於初始人群，以便可以用於早期治療。

So we do intend to cover early and late stage and that's one of the benefits of being where we are as a company is when that opportunity presents itself and we choose to want to fund maybe a second trial at that point we can decide and part of that will be how fast is the Phase three enrolling for India, the refractory population we look at and to have the lead example right. They've got about 180 patients in 15 months. And so that's about what we need. So if you really think about where we are today, 15 months from now we could be fully enrolled, but we only need half of that population to do our interim analysis. So we hope to have that interim analysis sometime in the second half of next year. And then we would just be waiting for the full patient population to get there in order to hopefully file on six month data.

因此，我們確實打算涵蓋早期和晚期階段，這是我們作為一家公司的好處之一，就是當機會出現時，我們選擇資助第二次試驗，那時我們可以決定並參與這就是印度第三階段招生的速度有多快，印度是我們關注的難治性人群，並且有正確的領先例子。15 個月內他們收治了約 180 名患者。這就是我們所需要的。因此，如果你認真考慮我們今天的情況，15 個月後我們可能會完全註冊，但我們只需要一半的人口來進行中期分析。因此，我們希望在明年下半年的某個時候進行中期分析。然後我們將等待全部患者到達那裡，以便有希望提交六個月的數據。

And so that's our that's our goal with the primary endpoint at six months.

這就是我們的目標，主要終點是六個月。

And when you think about the grand scheme of life, we're not that far away from hopefully kicking this trial here in second quarter and more importantly for senior next year. At this time, we should be and quickly enrolling halfway if everything goes as planned.

當你思考人生的宏偉計劃時，我們距離希望在第二季度啟動這項試驗並不遙遠，更重要的是明年的高年級。這時候，如果一切順利的話，我們應該盡快中途入學。

Thank you.

謝謝。

One moment, please.

稍等一會兒。

Our next question comes from the line of Steve Lichtman of Oppenheimer & Co. Your line is open.

我們的下一個問題來自 Oppenheimer & Co. 的 Steve Lichtman。您的線路已接通。

Thank you. Good evening, guys, and congrats on the progress of just level setting into a TTD., what is the data exactly that we're going to see there? I know we'll see the 17 week at this on inhaled three excuse me. What I know we'll see the 17 week at ADA, but what what's the anticipation at ETTD.?

謝謝。晚上好，夥計們，恭喜 TTD 級別設置的進展。我們將在那裡看到的數據到底是什麼？我知道我們會在第 17 週看到這一點，請原諒我吸入 3 個。據我所知，我們將在 ADA 上看到第 17 週，但 ETTD 的預期是什麼？

Yes. So we have a presentation there by agro Hersh, which will be the first dose on the meal tolerance there.

是的。因此，我們在那裡有 agro Hersh 的演講，這將是那裡的第一個關於膳食耐受性的劑量。

And Steve and I think that will allow us the opportunity to obviously have a presence on a podium there in front of everybody, but I'm sure he will be presenting some of the data and rationale why Afresa deserves a more fair chance in treatment. And he'll show that first dose data and that will be the primary focus there as you know, it's a technology conference with lots of innovation, and that's really a type one community and that comes from there. I think the other part of this is starting to talk about do you go to Europe, for example, is there another opportunity once we see the full dataset to expand to other markets in a meaningful way? And so zone that were there for that reason as much as anything in terms of showing the data, meaning global thought leaders.

史蒂夫和我認為這將使我們有機會在所有人面前登上頒獎台，但我相信他會展示一些數據和理由，說明為什麼阿弗雷薩應該得到更公平的治療機會。他將展示第一劑數據，這將是那裡的主要焦點，正如你所知，這是一個有很多創新的技術會議，這確實是一個類型的社區，來自那裡。我認為另一部分開始討論您是否去歐洲，例如，一旦我們看到完整的數據集，是否還有另一個機會以有意義的方式擴展到其他市場？因此，由於這個原因，該區域的存在與顯示數據一樣，意味著全球思想領袖。

Okay.

好的。

And then just on the endocrine business in general, I know you've been balancing growth and profitability. And you noted in your prepared remarks, you're optimizing the sales force footprint. So I guess are you are you been reducing the footprint being more strategic there. You've talked a little bit about what you've been doing and then what are the range of commercial investments you would consider assuming positive outcomes in inhaled three in one and two, would you add more to the sales force would be something else things?

然後就一般內分泌業務而言，我知道您一直在平衡成長和獲利能力。您在準備好的發言中指出，您正在優化銷售人員的足跡。所以我想你是否一直在減少足跡，以便更具策略性。您已經談論了一些您一直在做的事情，然後您會考慮的商業投資範圍是什麼，假設吸入三合一和二的積極成果，您會增加更多的銷售隊伍嗎？ ？

Yes, I think on the sales force footprint, you have to rewind back 18 months when we bought V-Go in May of '22, we dedicated roughly 2025 FTE.s to that brand alone.

是的，我認為就銷售團隊的足跡而言，你必須回溯 18 個月，當時我們在 22 年 5 月購買了 V-Go，我們將大約 2025 年的 FTE.s 專門用於該品牌。

And one it was on a two year decline not being promoted and we had to stabilize it.

其中之一是它連續兩年下降而沒有提升，我們必須穩定它。

And two, we didn't want to disrupt the Afresa field team. So we held We held overlapping expenses for quite a while.

第二，我們不想擾亂 Afresa 現場團隊。所以我們持有重疊費用很長一段時間。

And both of those businesses. And really our focus going into July and January this year was a two-step process around integrating V-Go into our commercial footprint on Afrezza. And then the second step was integrating the sales force into one voice one team and that took place in January of this year. There were some headcounts that were freed up as a result of that process. And we reinvested some of those headcounts into the field reimbursement support, the training, Tom and the the key account managers.

以及這兩項業務。實際上，我們今年 7 月和 1 月的重點是圍繞著將 V-Go 整合到我們在 Afrezza 的商業足跡中的兩個步驟。第二步是將銷售團隊整合為一個聲音一個團隊，這發生在今年一月。這一過程釋放了一些員工。我們將其中一些人員重新投入現場報銷支援、培訓、湯姆和大客戶經理。

We think the key account managers critical as we go into pediatrics and academic centers. That's not where Afrezza has been widely adopted.

我們認為，當我們進入兒科和學術中心時，大客戶經理至關重要。這並不是 Afrezza 被廣泛採用的地方。

So the first step is getting the key account managers to make sure we stabilize those big accounts. And then the second step will be hopefully filtering in from reps underneath them so they can maintain accounts or grow accounts day-to-day, while those key account managers take on the next group of accounts and get us ready for peak. So we have a multistep process here. It's not going to happen overnight, but the first step was getting the one field field footprint, one voice with one team and one new marketing campaign, which we're actually rolling out this week.

因此，第一步是讓大客戶經理確保我們穩定這些大客戶。然後，第二步將有望從他們下面的代表中過濾出來，這樣他們就可以每天維護客戶或增加客戶，而那些關鍵客戶經理則負責下一組客戶，讓我們為高峰做好準備。所以我們這裡有一個多步驟的過程。這不會在一夜之間發生，但第一步是獲得一個領域的足跡，一個團隊的一個聲音和一個新的行銷活動，我們實際上在本週推出了這些活動。

So I think the team will see that we've invested a lot in training and we have a couple of field trainers.

因此，我認為團隊會看到我們在培訓方面投入了大量資金，並且擁有幾名現場培訓師。

Now Tom spent, and that's going to be the number one focus this year is can we grow after that? We have been with the current footprint and the current infrastructure you put around that footprint and that model's working, I think we'll have conviction to go ahead and expand that model further bigger to easily add 50 to 100 more people. I wouldn't really do that until we saw groundbreaking data and that some of our current models working with KOL support from, I think the number one thing that the data will be the KOL support around that data because we have to be able to penetrate the academic centers, which are very pumped based. And I think that the pump data within our three is going to have to hold up in every objective way in terms of producing highs or reducing lows or improving a what's your timing range versus what are the data? It looks like it's going to be very compelling for us to be willing to spend money and that compelling our investment will be commensurate with the data and we're not going to we've been through for a long time. We're very excited about the day. We love the product, but we have to be objective around our investments and our ability to drive success, and I think the data is going to help support that.

現在湯姆花了，這將是今年的首要焦點是我們能否在此之後成長？我們一直在關注當前的足跡以及圍繞該足跡建立的當前基礎設施，並且該模型正在發揮作用，我認為我們將有信心繼續前進並進一步擴大該模型，以輕鬆增加 50 至 100 人。在我們看到突破性的數據以及我們當前的一些模型與 KOL 支持一起工作之前，我不會真正這樣做，我認為數據的第一件事將是圍繞該數據的 KOL 支持，因為我們必須能夠滲透學術中心非常活躍。我認為我們三個中的泵浦資料必須以各種客觀的方式保持不變，無論是產生高點還是減少低點或改善您的時間範圍與資料是什麼？看起來我們會非常願意花錢，而且我們的投資將與數據相稱，而且我們不會經歷很久。我們對這一天感到非常興奮。我們喜歡這個產品，但我們必須客觀地對待我們的投資和推動成功的能力，我認為數據將有助於支持這一點。

Understood.

明白了。

Thanks, Mike.

謝謝，麥克。

Thank you. One moment, please.

謝謝。稍等一會兒。

Our next question comes from the line of Gregory Renza of RBC Capital Markets. Your line is open.

我們的下一個問題來自加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。您的線路已開通。

Hi, Mike and team and finish on for Greg. Congrats on the quarter and thanks for taking my questions. I just wanted to parlay some questions on inhale three there. How should we be thinking about clinical bars for HBA 1C over the 17 week period in June? And then just considering real-world translatability of the trial design. Maybe if you can just remind us on the foreseen pushes and pulls for getting patients to switch between injectable insulin or pumps to Afrezza.

嗨，麥克和他的團隊，最後為格雷格完成任務。恭喜本季度，感謝您提出我的問題。我只是想解決一些關於吸入三的問題。我們該如何考慮 6 月 17 週內 HBA 1C 的臨床長條圖？然後只考慮試驗設計在現實世界中的可翻譯性。也許您能提醒我們一些可預見的推動和拉動，讓患者在註射胰島素或幫浦與 Afrezza 之間切換。

Thanks again, I think the first question I had was kind of the non-inferiority margin maybe in a health rate between the two arms.

再次感謝，我認為我遇到的第一個問題是兩臂之間的健康率中的非劣效性邊際。

And I think that the 0.4%, which was consistent with our pivotal trials with type one. And so that was those trials were done with a different conversion. And so we're hoping one of the as you saw in those trials was we got to the right dose. It just took 12 weeks. We're hoping by starting at a better risk upfront. We have 12 more weeks of benefit, and we saw the other part this year, if you may or may not recall this, we did a small study called ABC., which was there pilot trial on 25 patients to show, could you switch off an insulin pump? How do you adjust the basal and what happens over to 12 weeks for that study? And that study give us a lot of insights on things. We have to correct for this larger trial before we spent the money and, for example, a once-a-day titrated basal very well. The other side, we learned that they could be a little more aggressive with our basal titration. And so those are the types of things we tried to get more guardrails around this trial to ensure proper titration proper conversion. And obviously, doctors now use insulin pumps. And so that we're delivering we saw in the original trial was another manipulated pump very well because the doctors use pumps all day long where Afresa was due to that. They didn't know how to use it to its advantage in terms of dosing and no follow-up dosing, if necessary. So we kind of feel pretty good about the trial design. The controls within the trial to now is to wait for the data so that that gives you some perspective there. So we didn't design it for superiority that will be secondary endpoints that we'll watch out for.

我認為 0.4%，這與我們對第一型的關鍵試驗是一致的。所以這些試驗是透過不同的轉換完成的。因此，我們希望正如您在這些試驗中看到的那樣，我們得到了正確的劑量。僅僅花了12週。我們希望一開始就承擔更好的風險。我們還有12 週的受益期，今年我們看到了另一部分，如果您可能還記得，也可能不記得，我們​​做了一項名為ABC 的小型研究。該研究對25 名患者進行了試點試驗，以顯示，您可以關掉嗎胰島素幫浦？您如何調整基礎值以及該研究 12 週內會發生什麼？這項研究給了我們很多關於事物的見解。在我們花錢之前，我們必須修正這個更大規模的試驗，例如，每天一次滴定的基礎液非常好。另一方面，我們了解到他們可以對我們的基礎滴定更加積極一些。因此，這些就是我們試圖在這次試驗中獲得更多護欄的類型，以確保正確的滴定和正確的轉換。顯然，醫生現在使用胰島素幫浦。因此，我們在最初的試驗中看到的是另一個操控良好的泵，因為醫生整天都在使用泵，而 Afresa 正是因為這個原因。他們不知道如何利用它在劑量方面的優勢，並且在必要時沒有後續劑量。所以我們對試驗設計感覺非常好。目前試驗中的控制措施是等待數據，以便為您提供一些視角。因此，我們設計它的目的並不是為了優越性，而優越性將成為我們要關注的次要終點。

And then your second question around how do you think about this from a more world of the existing with pumps and pumps and physicians, and I think it comes down to patient motivation. At the end of the day, I think we will have KOL support. I think we will continue to see guideline support that we saw some updates this year in the standards of care for Afrezza and people are starting to understand the lower rates of hypoglycemia, the better time in range. And you're saying they want a real-time acting insulin as they've kind of adjusted every IT system and pumped together.

然後你的第二個問題是，你如何從現有的幫浦、幫浦和醫生的世界來思考這個問題，我認為這取決於病人的動機。最終，我認為我們會得到 KOL 的支持。我認為我們將繼續看到指導方針的支持，今年我們看到 Afrezza 護理標準的一些更新，人們開始理解低血糖發生率越低，範圍內的時間越長。你說他們想要一種即時作用的胰島素，因為他們已經調整了每個 IT 系統並一起泵送。

And what's next and what's next is really tightening control even further, and we're the best tool to help that. And so that's a lot of what we're talking about is how do we look at data on Afrezza on top of pumps potentially. We know that's an FDA challenge. We're also thinking about GLPs. And if you still have mealtime popping on GLP's, do you add Afrezza to those populations?

接下來的事情和接下來的事情實際上是進一步加強控制，而我們是幫助實現這一目標的最佳工具。因此，我們討論的許多內容是我們如何查看泵上 Afrezza 的數據。我們知道這是 FDA 的挑戰。我們也在考慮 GLP。如果您仍然有 GLP 的用餐時間，您是否會將 Afrezza 添加到這些人群中？

So we're starting to look and say, if we were to get positive data on an L. three as an early readout and we anticipate and want to look good, then what's the next leg up that we should really start exploring for more continued opportunities for Afresa. And we think about it. It's the pump market is the pediatric market, the decisional diabetes market, GLP market there's a lot of niche areas that are quite large that we think this brand can grow pretty rapidly over the coming years relative to it in the last five years.

因此，我們開始考慮並說，如果我們要獲得 L.3 的積極數據作為早期讀數，並且我們預期並希望看起來不錯，那麼我們應該真正開始探索更多持續的下一個階段是什麼阿弗雷薩的機會。我們思考一下。幫浦市場是兒科市場、決策性糖尿病市場、GLP 市場，有許多相當大的利基領域，我們認為相對於過去五年，這個品牌在未來幾年可以快速成長。

Great.

偉大的。

Thank you so much.

太感謝了。

Thank you. One moment, please.

謝謝。稍等一會兒。

Our next question comes from the line of Oren Livnat of H.C. Wainwright. Your line is open.

我們的下一個問題來自 H.C. 的 Oren Livnat。溫賴特。您的線路已開通。

Thanks. I got a couple one questions. Can you just help us better understand on how you arrived at the AGM pivotal study, sample size and powering? What's that based on and done with regards to the PRO endpoints. I guess since that's a new subjective endpoints in this space, what is the bar there? What does it need to look like a pretty effective competitor as you can have a follow-up at Barneys.

謝謝。我有幾個問題。您能否幫助我們更了解您如何得出年度股東會關鍵研究、樣本量和動力？這是基於 PRO 端點並針對 PRO 端點所做的事情。我想既然這是這個領域的一個新的主觀終點，那麼那裡的障礙是什麼？它需要什麼才能看起來像一個非常有效的競爭對手，因為你可以在巴尼斯百貨公司進行跟進。

These are two great questions that I think the biggest challenge to developing products for NTM. And that's why I think you're going to see continued Tom black of investment because you have to be to have enough capital to go through with it. In the case of Wyndham over spent many years building out the space and working with the FDA as well as the patient communities. And we know that the physician K-12 population really wants call Pfizer, you know, the patient population really wants Coface mean so and even FDA will say has been nothing but collaborative along this whole journey for five years and come back with them, Coram. So I think the market forces are aligned to help support us with the wind, the wind in our backs to push us forward and then you get into the risks of running these trials. And I think the reality is there are risks in this population. But given the efficacy on a on Copaxone, we estimated about a problem think a 20%, 30% effect size delta between us and placebo. And that's going to be the interim analysis to see. Are we on track for that or if not, we might increase the sample a little bit. That's number one.

我認為這是開發 NTM 產品的最大挑戰的兩個重要問題。這就是為什麼我認為你會看到湯姆布萊克繼續投資，因為你必須有足夠的資本來完成它。就 Wyndham 而言，它花費了多年時間來建立空間並與 FDA 以及患者社群合作。我們知道，K-12 人群的醫生真的想要打電話給輝瑞，你知道，患者群體真的希望科法斯是這樣的，甚至FDA 也會說，在整個過程中五年來一直在合作，然後與他們一起回來，Coram 。因此，我認為市場力量是一致的，可以為我們提供支持，風在我們背後推動我們前進，然後你將面臨進行這些試驗的風險。我認為現實是這個人群存在風險。但考慮到 Copaxone 的療效，我們估計了一個問題，即我們與安慰劑之間存在 20%、30% 的效應量增量。這將是我們要看到的中期分析。我們是否步入正軌，如果沒有，我們可能會稍微增加樣本。這是第一名。

The second part of the PRO.

PRO 的第二部分。

We went back and forth with the FDA for years, not just months on the PRO endpoint, the PR division and the feedback from the PR division for two reasons one, we weren't comfortable running a placebo-controlled trial, given that you can pretty much know what the active arm is. And we think that makes the PRO a difficult tool. And therefore, we tried to make it a secondary endpoint. The FDA was insistent should be a primary or co-primary endpoint. And so around that around the long story short, we landed where we did, which is a co-primary endpoint with the understanding that this is a little bit of a risky Tom endpoint, but that they agree, we've done the best we can to create the baseline measurements and the improvements in those key measurements that we've aligned to with the FDA and that the efficacy is going to have to matter in terms of sputum conversion as much as the PRO tool by itself. And so I'd just like I know I listened to the call, I mean what they're going through with FDA. We've had a lot of those questions. We work with them, and we've got a lot of their feedback already incorporated into our trial design. So now it's about the data and then what happens with the that data and how you analyze that data once it comes in, I'll be really important. But again, we'll work very closely with the FDA as I think they understand where we are they understand the pros and cons of that resident keep debating it. We thought it was more important to get the data and help get this drug across the finish line.

我們與 FDA 就 PRO 終點、PR 部門和 PR 部門的反饋進行了數年的反覆討論，而不僅僅是幾個月，原因有二：一，我們不願意進行安慰劑對照試驗，因為你可以幾乎知道主動臂是什麼。我們認為這使得 PRO 成為一個困難的工具。因此，我們試圖將其作為次要終點。FDA 堅持認為應該是主要或共同主要終點。因此，長話短說，我們到達了我們所做的地方，這是一個共同主要終點，我們知道這是一個有點冒險的湯姆終點，但他們同意，我們已經盡力了我們可以創建基線測量值以及對這些關鍵測量值的改進，我們已與FDA 保持一致，功效對於痰液轉化必須與PRO 工具本身一樣重要。所以我只是想知道我聽到了這個電話，我的意思是他們正在與 FDA 聯繫。我們有很多這樣的問題。我們與他們合作，他們的大量回饋已經納入我們的試驗設計中。所以現在是關於數據，然後這些數據會發生什麼，以及數據進入後如何分析這些數據，我將非常重要。但我們將再次與 FDA 密切合作，因為我認為他們了解我們的處境，他們了解該居民不斷爭論的利弊。我們認為更重要的是取得數據並幫助這種藥物衝過終點線。

Okay.

好的。

And just so I'm clear on your going based on some close hasn't been experienced efficacy wise. And are you assuming an improvement on that with your powering assumptions or even being conservative on that.

正因為如此，我很清楚你的做法是基於一些尚未經歷過的功效明智的。你是否認為你的動力假設會有所改善，甚至對此持保守態度。

Now I think when you when you look if we got into naive patients, we think we'd see a much higher efficacy rate.

現在我認為，當你觀察我們是否進入初治患者時，我們認為我們會看到更高的有效率。

But because we're focused on refractory. We think it will be a little less obvious in naive patients. And I think you saw that the MTRK. stated out there. There's only one study to really judge NTM endpoints on and that's therapies. And so I think when you go back in their development program, they had a 23% delta between the control and there is I am not sure they had a placebo to go back and double check the data. And so that's some of the work that we were going back and forth on is incorporating the placebo could have a placebo effect. And how much more do you have to be in highly powered trial with that potential risk. And that's a lot of back-and-forth with FDA.

但因為我們專注於耐火材料。我們認為對於初次接受治療的患者來說，這種情況會不太明顯。我想你已經看到 MTRK了。在那裡指出。只有一項研究可以真正判斷 NTM 終點，那就是療法。所以我認為當你回顧他們的開發計劃時，他們的對照組之間有 23% 的差異，而且我不確定他們是否有安慰劑可以回去仔細檢查數據。因此，我們反覆進行的一些工作就是將安慰劑納入其中，以產生安慰劑效應。面對這種潛在風險，您還需要進行多少次高強度試驗。這與 FDA 進行了大量的反覆討論。

So we've done the best we can.

所以我們已經盡力了。

We'll have an interim analysis. We think that's the most important aspect that we will get to in this trial. But assuming that's on track and we feel very good about the it up this trial to bring this to patients very quickly.

我們將進行中期分析。我們認為這是我們在這次試驗中將要達到的最重要的方面。但假設一切進展順利，並且我們對這次試驗的順利進行感到非常滿意，可以很快將其帶給患者。

All right.

好的。

And then just with regards to the TEMSATPI. situation, we're seeing a lot of headlines with regards to potential competition and lawsuits. I'm sure you couldn't or wouldn't comment directly on anyone else's litigation but if you are willing, I'm curious if you're able to comment on whether your orders coming into this year and your efforts there.

然後是關於 TEMSATPI。在這種情況下，我們看到了很多有關潛在競爭和訴訟的頭條新聞。我確信您不能或不會直接對其他人的訴訟發表評論，但如果您願意，我很好奇您是否能夠對您今年的訂單以及您在這方面所做的努力發表評論。

Inventory our manufacturing capacity expansion on reflect I guess, any possible assumptions or risks around competition? Are you like potentially waiting to do anything or is that pedal to metal pedal to the metal, so to speak on that front?

我想，盤點我們的製造能力擴張，反映出圍繞競爭的任何可能的假設或風險？你喜歡等待做任何事情，還是全力以赴，可以這麼說？

Yes, on the Travatan DP., I mean, we are making as much as we can around the clock.

是的，在 Travatan DP 上，我的意思是，我們正在全天候生產盡可能多的產品。

Nothing slowed down there and we know we wanted to build up inventory as well. So between the demand and the current mill we can manufacture, there's no slowing down where we are with Thomas IDTI. in terms of a competitor coming I mean, we've been hearing about this for years and whether it was the higher dose that was the indication everyone's been telling us about was just going to get approved and when we did get approved, then you're going to have ILD.

那裡沒有任何放緩，我們知道我們也想建立庫存。因此，在需求和我們目前可以製造的工廠之間，我們與 Thomas IDTI 的合作並沒有放緩。就競爭對手的到來而言，我的意思是，我們多年來一直聽說這件事，是否是每個人都告訴我們的更高劑量的跡象即將獲得批准，當我們確實獲得批准時，那麼你'我們將會患上ILD。

We've got IoT.

我們有物聯網。

We've been very honest with the market ever since this drug was under review and everything we've said has come true rate. We said we would expect ILD.

自從這款藥物接受審查以來，我們一直對市場非常誠實，我們所說的一切都已實現。我們說過我們會期待 ILD。

We've got IoT.

我們有物聯網。

We said remanufacturing remanufactured. We said we have nice conversion that's had a better conversion anyone expected. So from my perspective of SIDPI. is delivered on all parameters above and beyond expectations, despite an under forecasted launch, which put a lot of pressure on MannKind, and we did not miss one b. to make sure every patient at every day supply. And we did a lot. Our team worked incredibly hard this year to make that happen. We had record production in Q4 and we'll hopefully have equal record production in Q1 and even more production in Q2. So um, you know, if you looked at their store. They were after ILD. as their differentiator for some reason, and I'll be honest, if a patient can't tolerate the drug hunter file D, I don't see how their accelerators, which has three or four times more powder, if I recall. And so it's really about the patient tolerability. It's about the titration. It's about the powder load. It's about how you approach a patient treated patient, all these are really equal the important things. And anytime you launch a new drug, you find things out as you go along and you're modifying your go forward. And that's pretty much what I think I hear you T2S, as previously discussed, strong. It's to a great and NILD. as much as page what I heard from their call, our conversation with you to continue to be very positive. And I do want to mention another thing or in Japan so far is okay with the sputum conversion. So we'll do one trial on MannKind, one to one for Cliff, as I mean in terms of US and Japan will be one global study, but we'll cut the data two different ways. One for Japan for Steve and two primary for the US are co-primaries. So that will be an important aspect that we did struggle with the FDA saying why are you the only country in the world? It wants this sputum plus PRO where we don't have the same demands yet in the other countries around the world.

我們說再製造再製造。我們說過我們有很好的轉化，這是任何人都期望的更好的轉化。所以從我對 SIDPI 的角度來看。儘管發佈時間低於預期，給 MannKind 帶來了很大壓力，但所有參數均超出預期，我們沒有錯過任何一個 b。確保每一位患者每天的供應。我們做了很多。為了實現這一目標，我們的團隊今年付出了巨大的努力。我們在第四季的產量創紀錄，我們希望第一季的產量達到同樣的創紀錄水平，第二季的產量甚至更高。所以嗯，如果你看看他們的商店就知道了。他們在追尋ILD。出於某種原因，作為他們的差異化因素，老實說，如果患者不能忍受藥物獵人文件 D，我不知道他們的加速器如何，如果我記得的話，它的粉末含量是三到四倍。所以這其實與患者的耐受性有關。這是關於滴定的。這是關於粉末負載。這是關於你如何對待病人、治療病人，所有這些都是同等重要的事情。每當你推出新藥時，你都會在進展過程中發現一些問題，並修改你的前進方向。正如前面所討論的，這就是我所聽到的 T2S 的強大之處。這是一個偉大的和NILD。正如我從他們的電話中聽到的那樣，我們與您的對話仍然非常積極。我確實想提另一件事，或者在日本到目前為止，痰液轉換還可以。因此，我們將對MannKind 進行一項試驗，對Cliff 進行一對一的試驗，因為我的意思是，就美國和日本而言，這將是一項全球研究，但我們將以兩種不同的方式削減數據。史蒂夫的日本初選和美國的兩項初選是聯合初選。因此，這將是我們與 FDA 鬥爭的一個重要方面，為什麼你們是世界上唯一的國家？它想要這個痰加上 PRO，而我們在世界其他國家還沒有相同的需求。

So that's why the sputum you still got to kill the bug at the end of the day, and I think that becomes king in this disease.

所以這就是為什麼痰液最終還是要殺死細菌的原因，我認為這在這種疾病中是最重要的。

And can we do that really well, there's two questions how the PROs will work out. But when you look at the labels of PROs are not really strong claims at the end of the deck. So I still think efficacy is going to matter in terms of you have conversion.

我們能否真正做到這一點，有兩個問題是專業人士將如何發揮作用。但當你看到 PRO 的標籤時，你會發現這些標籤並不是真正強而有力的主張。所以我仍然認為功效對你的轉換來說很重要。

Okay.

好的。

And I look forward to talking to Steve some more about this accounting if they have that conversation.

如果他們有這樣的對話，我期待與史蒂夫更多地討論這個會計問題。

Yes, thank you for a moment, please.

是的，謝謝您。

Thank you.

謝謝。

Our next question comes from the line of Thomas Smith and Leerink Partners. Your line is open.

我們的下一個問題來自 Thomas Smith 和 Leerink Partners。您的線路已開通。

Hey, guys, good afternoon. Thanks for taking the questions and let me add my congrats on the progress and just a couple on our end.

嘿，夥計們，下午好。感謝您提出問題，讓我對所取得的進展表示祝賀，並對我們最後的幾句話表示祝賀。

I guess first on and KMNKD. one, the inhaled nintedanib program.

我想首先是 KMNKD。一、吸入性尼達尼布方案。

You just walk us through your expectations for the Phase one data in Q three and how quickly you think you could turn this around it and advance it into a Phase two trial in IPF patients. And then just remind us how you're planning for clinical supply and scale on the Tier one?

您只需向我們介紹您對第三季第一階段數據的期望，以及您認為可以多快扭轉這一局面並將其推進到 IPF 患者的第二階段試驗。然後提醒我們您如何規劃一級臨床供應和規模？

So on of the Phase one study, because it's a pretty quick study.

第一階段研究就這樣進行，因為這是一項相當快速的研究。

We were actually were doing going to do of IPF patients. It was the FDA who pushed us to consider healthy volunteers. So we actually switched from of the IPF patient to healthies, which saves us a lot of time and money. So that's number one. So that turnaround time should be pretty quick.

我們實際上正在為 IPF 患者做要做的事情。是 FDA 促使我們考慮健康志願者。所以我們實際上從 IPF 患者轉向了健康人，這節省了我們大量的時間和金錢。所以這是第一。所以這個週轉時間應該很快就會。

In terms of wrapping up Phase one and filing an end-of-Phase one meeting with FDA, hopefully by the end of the year.

就結束第一階段並向 FDA 提交第一階段結束會議而言，希望在今年年底前完成。

And then we're having good discussions internally.

然後我們在內部進行了良好的討論。

We just hired a new gentleman. I talked to our team who will be pivotal in building our development program beyond Phase one four to a one. And we're having good discussions internally. For example, we do a Ib study to get there sooner in parallel, while we continue to wait to kick off the trial for for the next phase, is it a two study going into a Phase three, so that work is happening as we speak. And I don't want to prematurely guess where we land, but just like capacity where we've pushed to not do a Phase two trial, one could argue that that's a little risky at the same time. We know these drugs work, we know the approximate dose we're trying to go after. And we know that that dose has produced a signaling effect that we expect. So on the case of tool one, we actually wanted those higher, and that's really the chronic tox data in Q4 to help support the higher dosing and assuming a patient can tolerate a higher dose, we think that's going to be one of our clinical differentiators for Tier one. So that will be the things we look for in the trials, can we dose higher is a tolerable and down? Do you have any of the GI. side effects that we see with the oral formulation?

我們剛聘請了一位新紳士。我與我們的團隊進行了交談，他們將在建立我們的開發計劃超越第一階段四到一的過程中發揮關鍵作用。我們內部正在進行良好的討論。例如，我們並行進行一項 Ib 研究，以便更快地實現這一目標，同時我們繼續等待下一階段的試驗開始，這是一項進入第三階段的兩項研究嗎？ 。我不想過早地猜測我們的著陸點，但就像我們推動不進行第二階段試驗的能力一樣，有人可能會說這同時有點冒險。我們知道這些藥物有效，我們知道我們想要服用的大致劑量。我們知道該劑量已經產生了我們預期的訊號效應。因此，就工具一而言，我們實際上想要更高的劑量，這實際上是第四季度的慢性毒性數據，以幫助支持更高的劑量，並假設患者可以耐受更高的劑量，我們認為這將是我們的臨床差異化因素之一對於一級。這就是我們在試驗中尋找的東西，我們可以在可以忍受的範圍內提高劑量還是降低劑量？你有 GI 嗎？我們在口服製劑中看到的副作用是什麼？

Got it.

知道了。

That's helpful. And then just on the on pipeline strategy and the priorities here. You obviously have a lot on your plate across the in-house studies for Afrezza and the cliff as I mean, the material one programs, but now you have the financial flexibility. I'm just wondering if you could talk about how you're from thinking about balancing external business development opportunities versus advancing sort of the internally derived candidates on your platform?

這很有幫助。然後是管道策略和優先事項。顯然，你在 Afrezza 和懸崖的內部研究方面有很多工作要做，我的意思是，材料一項目，但現在你有財務靈活性。我只是想知道您是否可以談談您是如何考慮平衡外部業務發展機會與在您的平台上推進內部衍生候選人的？

And that's a great question.

這是一個很好的問題。

I think the team is bursting at the seams and everything we're doing today and the good news is we have a great team is working extremely hard to make sure we get these INDs and to get them and he'll want to three study wrapped up and so from a financial flexibility, people don't realize we probably spent some in exact numbers, but over $30 million between inhaled one and then held three between people and trial costs but those trials are wrapping up this year going into next year.

我認為團隊正在全力以赴，我們今天所做的一切，好消息是我們有一個偉大的團隊正在非常努力地工作，以確保我們獲得這些新藥申請並獲得它們，他會想要完成三項研究因此，從財務靈活性來看，人們沒有意識到我們可能花費了一些確切的數字，但在吸入一個和然後在人和試驗成本之間持有三個之間超過了3000 萬美元，但這些試驗將於今年結束並進入明年。

As you think about Coface, I mean, there will be a little bit of overlap with the one to one but these other trials wrap up. And so you kind of see that phased in people also missed that. We have been funding tox trials and other data sets in R & D over the last couple of years on one, I wanted to have one as well as them final one. So there's been other investments in our data aren't as transparent. You don't talk about them as much. But again, some of those are ramping up and those those extra funds will be used to fund the Phase three trials. So I think we have the financial flexibility to ensure that if we can't funded out of cash flow generation that we are today that we have the cash on the balance sheet if we needed to. But our goal is to continue to run the Company lean like we have been and not get too far ahead of our skis until we continue to show consistent delivery as we go forward. I'll Steve, unless there's anything you want to add some there.

當你想到科法斯時，我的意思是，與一對一的試驗會有一點重疊，但這些其他試驗都會結束。所以你會發現分階段的人也錯過了這一點。在過去的幾年裡，我們一直在資助毒理學試驗和研發中的其他數據集，我想要一個以及最後一個。因此，我們的數據還有其他投資則沒那麼透明。你不太談論他們。但同樣，其中一些正在增加，這些額外資金將用於資助第三階段試驗。因此，我認為我們擁有財務靈活性，可以確保如果我們無法像今天這樣透過現金流產生來提供資金，那麼我們在需要時可以在資產負債表上擁有現金。但我們的目標是繼續像以前一樣精益運營公司，並且不會超出我們的滑雪板太多，直到我們在前進過程中繼續表現出一致的交付能力。我會告訴史蒂夫，除非你有什麼要補充的。

I know, Mike, I think the other original question was also around BD versus internal. I think you're exactly.

我知道，麥克，我認為另一個最初的問題也是圍繞著 BD 與內部的。我想你確實是這樣。

Yes, we're going to focus in on the internal priorities that we have. And if opportunities come along, we'll certainly assess them. But the focus will be internally first.

是的，我們將重點放在我們的內部優先事項上。如果有機會，我們一定會評估它們。但重點首先是內部。

Yes, and then on the BD side, we get lots of inbounds these days.

是的，然後在 BD 方面，這些天我們收到了很多界外球。

We're just busy. And so if we see something compelling, we'll look at it, but we're not actively trying to pursue anything we want to work with what we have and maximize the value what we have on our plate right now.

我們只是很忙。因此，如果我們看到一些令人信服的東西，我們會關注它，但我們並沒有積極嘗試去追求任何我們想要利用我們所擁有的東西來工作，並最大化我們現在擁有的價值。

Got it.

知道了。

That makes sense, guys. Thanks for taking the questions.

這是有道理的，夥計們。感謝您提出問題。

Thank you, Ramon, please.

謝謝你，拉蒙，請。

Our next question comes from the line of Anthony Petrone, Amazon retail group. Your line is open.

我們的下一個問題來自亞馬遜零售集團 Anthony Petrone。您的線路已開通。

My thought Thanks for squeezing me in here and congrats on a strong result. Also condolences on Alfred Mann passing to the team.

我的想法 感謝您將我擠在這裡，並祝賀取得了優異的成績。也對阿爾弗雷德·曼 (Alfred Mann) 轉會至球隊表示哀悼。

Maybe Steve, a couple on TV. So just the royalty agreement, just high level, why why was 1% sort of the right number. So Arne's point that potential competition. So what was the calculus and settling on 1%? And can you is there an option to further monetize high base of royalty, you know, under scenario maybe where you want to fast track one to one to a one or even add to the portfolio for future growth investments would you consider monetizing the royalty further as a source of funds? And then I'll have a couple of follow-ups on on diabetes for Mike.

也許是史蒂夫，電視上的一對情侶。所以只是特許權使用費協議，只是高水準，為什麼 1% 是正確的數字。所以阿恩的觀點是潛在的競爭。那麼微積分是多少並確定為 1% 呢？您是否可以選擇進一步將高額特許權使用費貨幣化，您知道，在您想要快速進行一對一甚至添加到投資組合以進行未來增長投資的情況下，您是否會考慮進一步將特許權使用費貨幣化作為資金來源？然後我將為麥克進行一些關於糖尿病的後續行動。

So Anthony, it's Steve. So what we did is we looked at what the value was for the Type A., so royalty in a very competitive environment. We had originally over 25 different purchasers come to the table and we wanted to keep a vast majority of the royalty to MannKind. So we thought 1% was right to get to about $300 million on our balance sheet, which would fund, not only our pipeline, but put us in a good position to fund the convertible debt when it matures in 2026. So yes, we can further monetize the royalty if there was a need for it, but we don't it could have a need for it at this point.

安東尼，是史蒂夫。所以我們所做的就是研究 A 型的價值，也就是在競爭非常激烈的環境中的特許權使用費。我們最初有超過 25 個不同的購買者來到談判桌，我們希望將絕大多數特許權使用費保留給 MannKind。因此，我們認為1% 的利率在我們的資產負債表上達到約3 億美元是正確的，這不僅可以為我們的管道提供資金，而且使我們能夠在2026 年到期時為可轉換債務提供資金。所以，是的，如果有需要，我們可以進一步將特許權使用費貨幣化，但我們目前可能不需要它。

And Steve, I'll just add two things on your question for the thing that drives royalty valuation is interest rates and the calculation you're using for expected interest rates.

史蒂夫，我只想在你的問題上添加兩件事，因為推動特許權使用費估值的因素是利率和你用於預期利率的計算。

And so over time, if interest rates come back down, the overall value of this royalty may go up even further, even as from the sales came off a little bit of trend for some reason. But we think that when we started this process, the royalty rate was not transparent to the public when you look back in June, July of 2023, and we wanted to bring value to our company around what is 10% of the royalty worry because we thought man and valued. And that 10% fell the right way to demonstrate that clearly to investors in the meantime, and we're midway through that process you to disclose the royalties. We didn't have to kind of work around that issue, number one. And then number two, the interest rates are high and that does create a bigger discount factor into that future cash flow. So those are things going in our favor, hopefully over the coming years.

因此，隨著時間的推移，如果利率回落，特許權使用費的整體價值可能會進一步上升，即使銷售因某種原因而略有下降。但我們認為，當我們開始這項流程時，當您回顧2023 年6 月、7 月時，特許權使用費率對公眾並不透明，我們希望為我們公司帶來約10% 的特許權使用費擔憂的價值，因為我們思想人並受到重視。10% 的下降是向投資者清楚地展示這一點的正確方式，我們正在中間過程中讓您披露特許權使用費。第一，我們不需要解決這個問題。第二，利率很高，這確實為未來現金流創造了更大的折扣因素。因此，這些都是對我們有利的事情，希望在未來幾年。

And the thing about a competitor coming, we know there's about So X percent converted from nebulizer to DPI. However, if there was another competing product out there that may help drive more adoption. And earlier adoption of DPI. which indirectly may help us right as you think about the future. So we're pretty bullish on DPI. and whether there's one or two players out there, it only helps more patients that can hopefully use the product more in earlier lines of treatment as well. So that's kind of how we looked at it. And we're we think MannKind's indirectly benefits as more competition does come to initiate that.

關於競爭對手的到來，我們知道大約有 X% 的人從霧化器轉換為 DPI。然而，如果有另一種競爭產品可能有助於推動更多採用。並較早採用 DPI。當您思考未來時，這可能會間接幫助我們。所以我們非常看好 DPI。無論只有一兩個參與者，它只會幫助更多的患者，他們也有望在早期治療中更多地使用該產品。這就是我們的看法。我們認為，隨著更多競爭的到來，MannKind 會間接受益。

And just on premium and health-oriented hail one, just from a combined outlook there for Afrezza, when you think about using Fraser with automated insulin pumps and then the pediatric indication just kind of level set again from from MannKind standpoint, you know how it's looking at those two opportunities from a market expansion standpoint for the product and actually which of the two indications are you most excited about you think you get faster traction in pediatrics or would it be in the combination use? Thanks again, and congratulations. It's not like you. I think the challenge with adding your presence on top of pumps besides the FDA, I'll just put that out.

就優質且健康為導向的冰雹來說，僅從Afrezza 的綜合前景來看，當您考慮將Fraser 與自動胰島素幫浦一起使用，然後從MannKind 的角度再次設定兒科適應症的水平時，您就知道它是怎樣的從產品市場擴張的角度來看這兩個機會，實際上，您對這兩個適應症中的哪一個最感興趣，您認為您在兒科領域會獲得更快的吸引力，還是會在聯合使用中？再次感謝，並恭喜。它不像你。我認為除了 FDA 之外，在泵上添加你們的存在是一個挑戰，我會把它說出來。

There is really the need that a patient sees and are they've always going to carry all this extra supplies with them and we use it on special occasions that use when they get home, it's not a full-time patient when you think about that value.

病人確實有這種需求，他們是否總是隨身攜帶所有這些額外的用品，我們在特殊場合使用它，當他們回家時使用，當你想到這一點時，這不是一個全職病人價值。

And that's one of things.

這是其中之一。

I think I've seen when people used to criticize our refill rates. So we knew roughly 20%, 30% of our Type one use Afresa intermittently, which kind of hurts your refill rates, right? And then we know type twos or compliance we want to be. So that's why it's so important to make sure that we are a front-and-center choice for patients who have mealtime control for one, improve their A1c. As we look out there, can we improve A1C? Can we improve time-in-range, that's we're hoping to see with these new trials versus when we got approval was just to show and the drug is as good as standard of care. And we think that's good enough for peds approval, but to cause an inflection, right, we want to show that hopefully, you're improving something on the product.

我想我看過人們批評我們的補充率。所以我們知道大約 20%、30% 的一類用戶會間歇性地使用 Afresa，這會損害您的補充率，對吧？然後我們就知道我們想要成為什麼樣的類型或合規性。因此，對於需要控制用餐時間、提高 A1c 水平的患者來說，確保我們成為他們的首要選擇非常重要。展望未來，我們能否提高 A1C？我們能否改善時間範圍，這是我們希望透過這些新試驗看到的，而我們獲得批准時只是為了證明該藥物與標準護理一樣好。我們認為這對於 peds 的批准來說已經足夠好了，但是為了引起變化，對吧，我們想表明希望你正在改進產品的某些東西。

Yes, which is going to be more critical, I think in health one will be the study that causes Afresa to become the next standard of care. And what I mean by that is, can we grow faster by putting more people out there, more marketing, more advertising?

是的，這將是更重要的，我認為在健康領域，一項研究將使 Afresa 成為下一個護理標準。我的意思是，我們能否透過投入更多人員、更多行銷、更多廣告來實現更快的成長？

Absolutely. I think we can.

絕對地。我想我們可以。

Is it going to be an inflection point that looks like a rocket. I think it's going to take another launch into a new market. And the good news about care, there's only about 500 doctors in the country that are meaningful, Pete endos and mostly academic centers and they're mostly about 40 50 centers in the country. And when you think about the study, it's only 40 centers in the US. So we are covering a majority of the key academic centers in this trial. So they will have first hand experience once the results are unbilled or finalize, at least until we kind of really make sure could you go faster by taking on a global trial.

這會是一個看起來像火箭的轉折點嗎？我認為這將需要再次進入新市場。關於護理的好消息是，全國祇有大約 500 名有意義的醫生，Pete Endos，而且大部分是學術中心，全國約有 40 50 個中心。當你考慮這項研究時，你會發現它在美國祇有 40 個中心。因此，我們在這次試驗中涵蓋了大多數主要學術中心。因此，一旦結果未計費或最終確定，他們將獲得第一手經驗，至少直到我們真正確定您可以透過進行全球試驗來更快地進行。

Absolutely. But we thought in order to have a major inflection, you better have the right experience with conditions of the year. And that's really what we're doing unfortunately, we cannot go against pumps in that trial. We wanted to, at the time switch off in foam pumps and include them the FDA would not allow us and that's one of the reasons we kicked off in health careers. We felt that once we did the ABC. trial, it would seek to switch people off insulin pumps, new FDA agreed at that point that we could add that to the trial. But a bit of bolt-on, we change and I want to get all three Arby's wasn't worth the distraction and so we feel very good about where we are in a one-two punch with that and how was announced.

絕對地。但我們認為，為了實現重大轉變，你最好對當年的情況有正確的經驗。不幸的是，這確實是我們正在做的事情，我們不能在那次試驗中反對泵浦。當時我們想關閉泡沫幫浦並將其納入 FDA 不允許的範圍，這也是我們開始從事健康事業的原因之一。一旦我們做了ABC，我們就有這樣的感覺。試驗中，它將尋求讓人們關閉胰島素泵，新 FDA 當時同意我們可以將其添加到試驗中。但有一點補充，我們改變了，我想得到所有三個阿比，這不值得分心，所以我們對我們在一對二拳中的位置以及如何宣布這一點感到非常滿意。

Appreciate that.

感謝。

Thank you.

謝謝。

I'm showing no further questions at this time. Like to turn the call back over to Michael Castagna, CEO, for any closing remarks.

我目前沒有提出任何進一步的問題。希望將電話轉回給執行長 Michael Castagna，讓其發表結束語。

Thank you, Valerie, and thank you all for the analyst coming and look forward to seeing hopefully a couple of UATTD. also will be on a non-deal roadshow of in some key cities meeting with our investors. And just want to say thank you to everyone. It's been a great year so far. We're super excited. Everything is off to a great start, and we're looking forward to making 2024 another record-setting year. So thank you again for everything, Steve and Dave and everything else. Thank you for all the work everyone's doing. Have a great day.

謝謝你，Valerie，也謝謝大家分析師的到來，並期待看到一些 UATTD。也將在一些重點城市進行非交易路演，與我們的投資者會面。只是想向大家表達感謝。到目前為止，這是美好的一年。我們非常興奮。一切都有一個好的開端，我們期待 2024 年再創紀錄。再次感謝你們所做的一切，史蒂夫和戴夫以及其他一切。感謝大家所做的一切工作。祝你有美好的一天。

Thank you. Ladies and gentlemen, this does conclude today's conference thank you all for participating. You may now disconnect. Have a great day.

謝謝。女士們、先生們，今天的會議到此結束，感謝大家的參與。您現在可以斷開連線。祝你有美好的一天。