MannKind Corp (MNKD) 2024 Q2 法說會逐字稿

Good morning, and welcome to the MannKind Corporation's second-quarter 2024 financial results earnings call. As a reminder, this call is being recorded, August 7, 2024, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days.

早安，歡迎參加 MannKind 公司 2024 年第二季財務業績財報電話會議。謹此提醒，本次通話將於 2024 年 8 月 7 日進行錄音，並將在本次通話結束後不久在 MannKind Corporation 網站上播放，有效期約為 90 天。

This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could 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。此類前瞻性陳述存在風險和不確定性，可能導致實際風險與所陳述的預期有重大差異。有關該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 季度報告、收益報告以及為本次演示準備的幻燈片。

Joining us today for MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Chris Prentiss. I'd like to turn the conference over to Mr. Castagna. Please go ahead, sir.

今天加入 MannKind 的有執行長 Michael Castagna；和財務長克里斯·普倫蒂斯。我想把會議交給卡斯塔尼亞先生。請繼續，先生。

Thank you, operator. Good morning, everyone. Excited to be here. Calling in from Danbury, Connecticut, today, and joining me is Chris Prentiss, our Chief Financial Officer. Today, we'll go over our traditional operational and pipeline highlights, quick financial review by Chris with some closing remarks by myself and we'll move to Q&A.

謝謝你，接線生。大家早安。很高興來到這裡。今天，我們的財務長 Chris Prentiss 從康乃狄克州丹伯里打電話來與我一起。今天，我們將回顧我們的傳統營運和管道亮點、克里斯的快速財務審查以及我自己的一些結束語，然後我們將進入問答環節。

Let me begin by talking about some of the second-quarter 2024 highlights. First, we had record revenue on Tyvaso DPI between manufacturing and royalty revenue coming in. Second, clofazimine inhalation suspension is well on its way with fast track designation by the FDA as well as several sites now activated and ready for patient enrollment.

首先讓我談談 2024 年第二季的一些亮點。首先，我們在 Tyvaso DPI 上取得了創紀錄的製造收入和特許權使用費收入之間的收入。其次，氯法齊明吸入混懸劑進展順利，已獲得 FDA 的快速通道指定，並且多個站點現已啟動並準備好患者入組。

And thirdly, nintedanib DPI is well underway with results expected here in Q4, along with chronic tox. We're now in our third cohort of single dose patients anxiously waiting to move to the MAD section of the study shortly. In our endocrine business, we had second quarter revenue of $20.8 million, driven by Afrezza. I'll talk about that shortly. INHALE-1 topline results for pediatrics is expected here in Q4, and we're excited for this pivotal moment in our history to unveil these results.

第三，尼達尼布 DPI 進展順利，預計在第四季度取得結果，同時還有慢性毒性。我們現在屬於第三組單劑量患者，焦急地等待很快進入研究的 MAD 部分。在我們的內分泌業務中，在 Afrezza 的推動下，我們第二季的營收為 2,080 萬美元。我稍後會討論這個問題。INHALE-1 兒科的主要結果預計將在第四季度公佈，我們很高興在我們歷史上的這個關鍵時刻公佈這些結果。

And then the third part of endocrine is INHALE-3. We met its primary endpoint. 17-week data were presented at ADA and were very well received. We're coming up on our 30-week data readout here in the second half and implementing our ADA post-success plan.

然後內分泌的第三部分是INHALE-3。我們達到了其主要終點。 17 週的數據在 ADA 上發布並受到熱烈歡迎。我們將在下半年公佈 30 週的數據並實施我們的 ADA 成功後計劃。

For financial results, record revenue for the company of $72 million or 49% with a GAAP net loss of $2 million and non-GAAP of $14 million that Chris will talk about shortly.

就財務業績而言，公司收入創紀錄為 7,200 萬美元，即 49%，GAAP 淨虧損為 200 萬美元，非 GAAP 淨虧損為 1,400 萬美元，克里斯將很快談到這一點。

We ended the quarter with a strong balance sheet and we continue to delever the company and reducing dilution to shareholders by paying down the Mann convertible debt and cash and stock as opposed to stock only.

我們以強勁的資產負債表結束了本季度，並透過償還曼恩可轉換債務以及現金和股票（而不是僅股票），繼續對公司進行去槓桿化並減少對股東的稀釋。

Now let me talk about clofazimine inhalation suspension. We look at NTM as an opportunity with two players over the coming years. Our case has great data readout in early stage and they continue to penetrate the markets in Japan and the US. As we look at the refractory population being about 10%, 15%, 20% of this market, we see this as a very large opportunity to bring a new entrant that could be more convenient with really good lung coverage here in the US as well as Japan.

現在我來說說氯法齊明吸入混懸液。我們將 NTM 視為未來幾年與兩名玩家合作的機會。我們的案例在早期階段就有很好的數據讀出，並且它們繼續滲透到日本和美國市場。當我們看到難治性人群約佔這個市場的10%、15%、20% 時，我們認為這是一個非常好的機會，可以引入一個新進入者，在美國也有很好的肺部覆蓋率，可以更方便。

Let me talk to you for a second about our Phase 3 design. The key attributes of this product are number one, 28 days on treatment with 56 days of treatment. What that means is the patient will have one [co-pay] for the 28 days, followed by two months off because the drug has a long half-life. We believe it's really important to get deep lung penetration in this disease as the macrophages are deep in the lungs and they'll take the clofazimine in. And because of the half-life, it will take about two months for it to return back to baseline.

讓我和您談談我們的第三階段設計。本產品的關鍵屬性是第一，治療28天，治療56天。這意味著患者將需要支付 28 天的[自付額]，然後可以休息兩個月，因為該藥物的半衰期很長。我們認為，在這種疾病中，深入肺部滲透非常重要，因為巨噬細胞位於肺部深處，它們會吸收氯法齊明。而且由於半衰期的原因，大約需要兩個月的時間才能恢復到基線。

We see that same thing with month four coming on the treatment and then month five and six off treatment. The primary endpoint of the study will be six months, and we're looking at a dose of 80 milligrams of clofazimine in a 2 to 1 randomization. We will have an interim analysis after the first 100 people enrolled, and that we'll decide whether the trial should be larger to make sure we hit our endpoints or it's sufficiently staffed to reach the primary endpoint.

我們在接受治療的第四個月以及停止治療的第五個月和第六個月看到了同樣的情況。研究的主要終點將是六個月，我們正在以 2 比 1 的隨機分組研究 80 毫克氯法齊明的劑量。在前 100 名受試者入組後，我們將進行中期分析，並決定是否應該擴大試驗規模以確保我們達到終點，或是否有足夠的人員來達到主要終點。

The co-primary endpoint in US is sputum culture conversion and patient-reported outcomes and the primary endpoint for Japan has been aligned and that is sputum conversion only. We also have orphan and QIDP designation along with other IP, given us a minimum of 12 years exclusivity. Japan and FDA have aligned to a single trial. And we're also considering creating an expanded access program. We'll keep you posted on that.

美國的共同主要終點是痰培養轉化和患者報告的結果，而日本的主要終點已經一致，僅是痰培養轉化。我們還擁有孤兒和 QIDP 頭銜以及其他智慧財產權，賦予我們至少 12 年的獨家經營權。日本和 FDA 已就一項試驗達成協議。我們還在考慮創建一個擴展的訪問計劃。我們會及時通知您。

On 201 as you see this market while it is a crowded in terms of development, there are very few options on the market for patients. We're excited of what we see from United Therapeutics and TETON 1 and 2 reading out next year for Tyvaso, but more importantly, this is on the backbone of OFEV as the market brand leader in IPF. And we believe, while that's a phenomenal drug and it's helped thousands of people live longer, we also believe there's an opportunity to enhance the quality of life that people experience when going on OFEV and that's really our main focus here as we look at this opportunity, how do we bring potentially improved tolerability relative to GI side effects, specifically that occur with OFEV where 50% of the people traditionally drop off treatment because of GI side effects alone.

在201上，如你所見，這個市場雖然在開發方面很擁擠，但市場上可供患者選擇的選擇卻很少。我們對聯合治療公司以及 TETON 1 和 2 明年為 Tyvaso 宣讀的結果感到興奮，但更重要的是，這是 OFEV 作為 IPF 市場品牌領導者的支柱。我們相信，雖然這是一種非凡的藥物，它幫助成千上萬的人活得更長，但我們也相信，有機會提高人們在使用OFEV 時所經歷的生活質量，這確實是我們在考慮這個機會時的主要關注點，我們如何潛在地改善對胃腸道副作用的耐受性，特別是 OFEV 發生的情況，傳統上 50% 的人僅因為胃腸道副作用而放棄治療。

We also believe that we can dose, hopefully a little bit higher, directly into the lungs and get higher lung concentrations, and this is really our focus here on this product is, can we dose appropriately and tolerable and does that show an improved in GI tolerability. The Phase 1 data readout in chronic tox are expected to both come in here in Q4 and we will then file a meeting with the FDA to move this to a Phase 2/3 design in 2025.

我們也相信，我們可以將劑量（希望稍微高一點）直接進入肺部並獲得更高的肺部濃度，這實際上是我們對該產品的關注點是，我們的劑量是否適當且可耐受，以及是否顯示出胃腸道的改善耐受性。慢性毒物的第一階段數據預計將在第四季度公佈，然後我們將與 FDA 召開會議，在 2025 年將其轉移到第二/第三階段設計。

Now moving on to our endocrine business. Year-to-date, revenue of $39.5 million, predominantly driven by Afrezza, I'll talk about in a second. V-GO was deprioritized in Q1 as you may recall, and we restructured the field team so that we've had a different business model coming into the year and you'll see some of that result here as I talk about our script growth. Afrezza Q2 sales alone over the prior year grew 20% to $16.3 million.

現在轉向我們的內分泌業務。今年迄今為止，收入為 3950 萬美元，主要由 Afrezza 推動，我稍後會談到。您可能還記得，V-GO 在第一季被取消優先級，我們重組了現場團隊，以便我們在今年擁有不同的業務模式，當我談論我們的腳本增長時，您會在這裡看到其中的一些結果。光是 Afrezza 第二季銷售額就比前一年成長了 20%，達到 1,630 萬美元。

Moving into prescriptions, you can see Q1 versus Q2, 8% NRx growth leading the 5% TRx growth quarter over quarter. The NRxs are the leading indicator what to expect three to six months later. It's nice to see that the NRx change is paying off in TRx, and we hope to continue to see the type of growth as we go into Q3 and Q4 this year.

進入處方領域，您可以看到第一季與第二季相比，8% 的 NRx 成長領先 5% 的 TRx 季度環比增長。NRx 是三到六個月後預期的領先指標。很高興看到 NRx 的變化在 TRx 中得到了回報，我們希望在今年進入第三季和第四季時繼續看到這種成長。

As you may not have read our readout on ADA with INHALE-3, this was presented at an oral presentation by seven world thought leaders. The sub-analysis found several key attributes to this trial. Number one, inhaled insulin achieved a target A1c less than 7%in 30% of participants versus 17%. Additionally, 24% of Afrezza was one in four patients versus 13% usual care met timing range greater than 70% with no increased hypoglycemia.

由於您可能還沒有閱讀我們關於 ADA 與 INHALE-3 的解讀，這是由七位世界思想領袖在口頭演講中提出的。子分析發現了該試驗的幾個關鍵屬性。第一，吸入胰島素使 A1c 目標值在 30% 的參與者中低於 7%，而這一比例為 17%。此外，24% 的 Afrezza 患者佔四分之一，而 13% 的常規護理患者滿足時間範圍大於 70%，且低血糖情況沒有增加。

Over 50% of the subjects who got to the end of the trial said they'd like to continue on taking Afrezza and the reason that such an important number is 50% of the people in this trial were coming off the best technologies of AID systems, Omnipod, and were generally satisfied with their treatment and to see that even when people switch they maintain control, they'd like to continue to have the freedom that Afrezza brings to them.

在試驗結束時，超過 50% 的受試者表示他們願意繼續服用 Afrezza，之所以如此重要，是因為試驗中 50% 的受試者正在擺脫 AID 系統的最佳技術、Omnipod，並且對他們的待遇普遍感到滿意，並且看到即使人們更換他們仍然保持控制，他們希望繼續擁有Afrezza 給他們帶來的自由。

We've met our 17-week primary endpoint, and our full 30-week data is expected to read out later this year. And we'll likely give that information to shareholders here in Q4.

我們已經達到了 17 週的主要終點，完整的 30 週數據預計將於今年稍後公佈。我們可能會在第四季向股東提供這些資訊。

When you look at the meal challenges here on the right, the RAA is the red line, clearly shows the post-perennial glucose excursions relative to the initial dose of both groups you can see a distinct difference in the first two hours. And at the end of the study, when people were titrate to Afrezza, we did a second meal challenge, you can see greater improvement meal time control as people learned how to use the product.

當您查看右側的飲食挑戰時，RAA 是紅線，清楚地顯示了兩組相對於初始劑量的常年血糖波動，您可以看到前兩個小時內的明顯差異。在研究結束時，當人們滴定 Afrezza 時，我們進行了第二次用餐挑戰，隨著人們學會如何使用產品，您可以看到用餐時間控制有了更大的改善。

And what this gives us is hope that, when properly dosed, Afrezza can really impact post-perennial control significantly over the current standard of care. This data was just published in diabetes care last couple of weeks ago.

這給我們帶來了希望，如果劑量適當，Afrezza 確實可以對當前護理標準的多年後控制產生顯著影響。該數據幾週前剛發表在《糖尿病照護》雜誌上。

As we look out, we see INHALE-3 is pivotal to transforming the adult population but also laying the groundwork for pediatrics, where insulin pumps is the predominant competitor of choice when it comes to choosing inhaled injected or an alternative delivery mechanism. And we believe the switch study in INHALE-3 showing consistent results of efficacy and the overall population as well as sub populations to be important as the INHALE-1 trial was only in MDI patients, and that was by design, to really show and control the one difference in the trial. The INHALE-1 day will read out shortly, and we'll intend to file that next year for approval, hopefully, in the future years for launch.

正如我們所看到的，我們看到INHALE-3對於改變成年人群至關重要，同時也為兒科奠定了基礎，在選擇吸入註射或替代輸送機制時，胰島素幫浦是主要的競爭對手。我們相信 INHALE-3 中的轉換研究顯示了一致的療效結果，並且總體人群和亞人群非常重要，因為 INHALE-1 試驗僅在 MDI 患者中進行，而且這是有意設計的，以真正顯示和控制審判中的唯一區別。INHALE-1 日將很快讀出，我們打算明年提交批准，希望在未來幾年內啟動。

When we look at Afrezza since I've gotten here, we've continued to grow year over year in a really good way. As we look out over the next 10, 15-plus years, we see nothing slowing down Afrezza growing year over year. Finally, we will have proper data readouts, proper label updates, and now we have a capital and talent to continue to scale this business. We will wait for the data readouts. We are conducting some independent market research, so we can update you in the coming quarters on what our plans are and what to do with the data readouts as well as the additional indication what that will mean for shareholders. But we have grown consistently. We will continue to grow this brand for years to come.

自從我來到這裡以來，當我們審視 Afrezza 時，我們發現我們每年都在以非常好的方式持續成長。展望未來 10 年、15 年以上，我們沒有看到任何因素會減緩 Afrezza 的逐年成長。最後，我們將擁有適當的數據讀出、適當的標籤更新，現在我們擁有資本和人才來繼續擴大這項業務。我們將等待數據讀出。我們正在進行一些獨立的市場研究，因此我們可以在未來幾季向您通報我們的計劃以及如何處理資料讀數，以及這對股東意味著什麼的額外說明。但我們一直在成長。我們將在未來幾年繼續發展這個品牌。

I now would like to turn it over to Chris.

我現在想把它交給克里斯。

Thanks, Mike, and good morning, everyone.

謝謝麥克，大家早安。

I am pleased to review select second quarter 2024 financial results. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter 2024 as well as our 10-Q, which was filed with the SEC this morning.

我很高興回顧 2024 年第二季的部分財務表現。請參閱我們今天早些時候發布的新聞稿，以了解我們 2024 年第二季度的財務業績摘要以及今天早上向 SEC 提交的 10-Q 報告。

The second quarter with total revenues of $72 million marked our ninth consecutive period of quarter-on-quarter revenue growth and a 49% increase compared to the second quarter of 2023. For the six months period, we recorded total revenues of $139 million, a 55% increase over the prior year period.

第二季總營收為 7,200 萬美元，標誌著我們連續第九個季度營收成長，與 2023 年第二季相比成長 49%。在這六個月期間，我們的總營收為 1.39 億美元，比去年同期成長 55%。

Let's now discuss the details. Tyvaso DPI royalties contributed $26 million in second quarter revenue, an increase of 34% over the second quarter of 2023 and $48 million or 57% for the six-month period. As we heard on UT's earnings call last week, they continue to experience strong patient demand and are encouraged by the record referrals and new patient starts during the quarter for both PAH and PH-ILD patients.

現在我們來討論細節。Tyvaso DPI 特許權使用費為第二季度收入貢獻了 2,600 萬美元，比 2023 年第二季度增長了 34%，六個月期間增長了 4,800 萬美元，增長了 57%。正如我們上週在 UT 的財報電話會議上聽到的那樣，他們繼續感受到強勁的患者需求，並受到本季度 PAH 和 PH-ILD 患者創紀錄的轉診和新患者開始的鼓舞。

Collaboration and services revenue was $26 million, an increase of 132% versus second quarter of 2023, The six-month period was $51 million or 125% compared to the same period of 2023. The increase over the prior year periods resulted from a substantially higher level of production activity, which was sold through to UT.

協作和服務收入為 2,600 萬美元，較 2023 年第二季成長 132%；六個月期間為 5,100 萬美元，較 2023 年同期成長 125%。與上一年同期相比的成長是由於生產活動水準大幅提高，並透過銷售給 UT。

Afrezza net revenue of $16 million grew 20% versus second quarter 2023 which was primarily driven by volume growth, a lower gross to net percentage of 37% versus 39% in the prior year, and a price increase. Similarly in the six month period, Afrezza net revenue grew 18% to $31 million, primarily driven by a reduction in gross to net percentage and price. The lower gross to net percentage was mainly the result of a change in estimate for Afrezza product returns.

Afrezza 淨收入為 1,600 萬美元，與 2023 年第二季相比增長了 20%，這主要是由於銷量增長、總淨收入百分比從上一年的 39% 下降至 37%，以及價格上漲。同樣，在這六個月期間，Afrezza 淨收入增長了 18%，達到 3,100 萬美元，這主要是由於總淨收入百分比和價格的下降。毛淨百分比下降主要是由於 Afrezza 產品退貨預估發生變化。

V-GO declined 7% to $4 million in the second quarter of 2024 and 11% to $9 million for the six month comparable period. The decline reflects lower demand as we have focused our attention on Afrezza.

V-GO 在 2024 年第二季下降了 7%，至 400 萬美元，在六個月的可比期間下降了 11%，至 900 萬美元。下降反映出需求下降，因為我們將注意力集中在 Afrezza 上。

The next slide shows our revenue growth by source and basic EPS on a quarter-by-quarter basis over a rolling eight-quarter period from the third quarter of 2022 through the second quarter of 2024. For the second quarter of 2024, total revenues of $72 million increased 9% sequentially versus the first quarter of 2024.

下一張投影片顯示了我們從 2022 年第三季到 2024 年第二季的滾動八個季度中逐季度按來源和基本每股收益劃分的收入增長。2024 年第二季的總營收為 7,200 萬美元，較 2024 年第一季季增 9%。

After three quarters of positive earnings per share, from Q3 2023 through the first quarter of 2024, we had a net loss in the current quarter of $2 million or $0.01 per share. This was the result of our early repayment of the Mann Group convertible note and mid-cap senior secured notes, which we completed in April and resulted in an accounting charge of $7 million recorded as a loss on extinguishment of debt.

從 2023 年第三季到 2024 年第一季度，在連續三個季度實現正每股收益之後，我們本季的淨虧損為 200 萬美元，即每股 0.01 美元。這是我們提前償還曼恩集團可轉換票據和中型優先擔保票據的結果，我們於 4 月完成了償還，導致 700 萬美元的會計費用記錄為債務清償損失。

Now to our GAAP to non-GAAP reconciliation. We had a GAAP net loss for the quarter of $2 million, which, when adjusted for non-GAAP items, results in non-GAAP net income of $14 million. This compares to a non-GAAP loss of approximately $400,000 in the prior year quarter. For the six-month period, we reported net income of $9 million and non-GAAP net income of $29 million. For the six-month period in 2023, we reported a net loss of $15 million and a non-GAAP net loss of $6 million.

現在我們的 GAAP 與非 GAAP 調整表。我們本季的 GAAP 淨虧損為 200 萬美元，根據非 GAAP 項目進行調整後，非 GAAP 淨利潤為 1,400 萬美元。相比之下，去年同期的非 GAAP 虧損約為 40 萬美元。在這六個月期間，我們報告的淨利潤為 900 萬美元，非 GAAP 淨利潤為 2900 萬美元。在 2023 年的六個月期間，我們報告的淨虧損為 1,500 萬美元，非 GAAP 淨虧損為 600 萬美元。

The second quarter represents our fourth consecutive quarter of positive non-GAAP earnings, which we expect to continue as we execute on our current business plan. As we reflect on our progress on the first half of the year, total revenues grew by 55% for the six-month period compared to the prior year, driven by growth in both our Tyvaso DPI related revenue and Afrezza growth.

第二季度是我們連續第四個季度實現非公認會計準則盈利，我們預計在執行當前的業務計劃時將繼續實現這一盈利。當我們回顧上半年的進展時，在 Tyvaso DPI 相關收入和 Afrezza 成長的推動下，六個月內的總收入與去年同期相比增長了 55%。

At $139 million, this gives us an annual run rate of over $275 million in revenues. Net income for the first half of the year was $9 million and non-GAAP income was $29 million. This demonstrates the significant progress we have made as our revenues are supporting our pipeline development efforts.

1.39 億美元，這使我們的年收入超過 2.75 億美元。上半年淨利為 900 萬美元，非 GAAP 收入為 2,900 萬美元。這表明我們取得了重大進展，因為我們的收入正在支持我們的管道開發工作。

Cash and investments were $262 million at the end of the quarter. This is after the repayment of both the Mann Group and mid-cap notes in April, leaving only the $230 million senior convertible notes due in March 2026. This cash position, combined with our delevered balance sheet, puts us in a strong position to continue to invest in our commercial products and our exciting pipeline.

截至本季末，現金和投資為 2.62 億美元。這是在 4 月償還曼恩集團和中型票據之後，只剩下 2026 年 3 月到期的 2.3 億美元高級可轉換票據。這種現金狀況，加上我們去槓桿化的資產負債表，使我們處於有利地位，可以繼續投資我們的商業產品和令人興奮的管道。

With that, I will turn it back over to Mike

這樣，我會把它轉回給麥克

Thank you, Chris.

謝謝你，克里斯。

As we look out over the next 12 months, here are some of the milestones we're going to talk about. I want to say thank you to the hard work the team has achieved in the first half, starting with our IND submissions here in Q1 which led to a kickoff of a bunch of work that we'll be looking forward to as investors and employees and patients and providers over the coming quarters and years.

展望未來 12 個月，我們將討論以下一些里程碑。我想對團隊在上半年取得的辛勤工作表示感謝，從我們在第一季度提交 IND 開始，這導致了我們作為投資者和員工所期待的一系列工作的開始。患者和提供者。

Tyvaso DPI continues to progress nicely as you think about what we've been doing in Danbury between making product today to supply the market demands while preparing for hopefully positive readouts on TETON-1 and 2 and global expansion there with United Therapeutics. Our high-speed fill/finish line is now operational and certified on most of the strengths for Tyvaso DPI.

當你想到我們在丹伯里所做的事情時，Tyvaso DPI 繼續取得良好進展，從今天生產產品以滿足市場需求，同時為TETON-1 和2 的積極結果做好準備，以及與United Therapeutics 一起進行全球擴張。我們的高速填充/成品生產線現已投入運行，並通過了 Tyvaso DPI 的大部分優勢認證。

The spray drying capacity will be completed here in the third quarter. It's been installed, and now we're just running through the PPQ. What you'll see in the first half that will require some stability time and then filing with the FDA for approval. We expect that to be fully operational in the first half of '25, well in advance of TETON-1 and 2 reading out.

噴霧乾燥產能將於第三季完成。它已經安裝完畢，現在我們只需運行 PPQ 即可。您將在上半年看到需要一些穩定時間，然後向 FDA 提交批准。我們預計它將在 25 年上半年全面投入運行，遠早於 TETON-1 和 2 的讀出。

As you look at INHALE-1 and INHALE-3, these are two pivotal trials we invested in over the last several years that are critical to the transformation we expect to bring to Afrezza over the coming quarters and years ahead. These data readouts will happen here in the second half, and they will set the stage for continued data publication and data releases for years to come at the various diabetes conferences around the world. We are just getting started on what this can mean for ourselves as employees, as patients, and as shareholders. And we're looking forward to continuing to give you more information as it comes in, in the coming quarters ahead.

當您查看INHALE-1 和INHALE-3 時，您會發現這是我們在過去幾年中投資的兩項關鍵試驗，對於我們預計在未來幾個季度和未來幾年為Afrezza 帶來的轉型至關重要。這些數據讀出將在下半年進行，它們將為未來幾年在世界各地的各種糖尿病會議上持續發布數據和發布數據奠定基礎。我們才剛開始了解這對我們自己作為員工、病人和股東意味著什麼。我們期待在未來幾個季度繼續為您提供更多資訊。

I think about the key value drivers that lay in front of us. Number one, the pipeline is not reflected in the value of our company. We continue to believe we're undervalued when we look at the value that's Tyvaso DPI royalties and manufacturing revenue relative to the other assets we have ongoing in the company. Just alone looking at 101, that we now look to be the only Phase 3 trial in the future, bringing this novel innovation to an unmet need population in NTM, where there's over 100,000 patients in the US and roughly 15,000 that are refractory alone. And for every 1000 patients, this is $100 million in that revenue to MannKind.

我思考了擺在我們面前的關鍵價值驅動因素。第一，管道並沒有反映在我們公司的價值上。當我們考慮 Tyvaso DPI 特許權使用費和製造收入相對於我們公司現有的其他資產的價值時，我們仍然認為我們的價值被低估了。光是看 101，我們現在就認為它是未來唯一的 3 期試驗，將這項新穎的創新帶給 NTM 未滿足的需求人群，美國有超過 10 萬名患者，其中大約有 15,000 名難治性患者。每 1000 名患者，MannKind 的收入就達到 1 億美元。

When I think about OFEV, the potential for this opportunity to help people living with IPF have a more tolerable option, let alone if we can see better efficacy, that would be amazing. This is a $4 billion market and growing, with lots of novel innovation coming, where we OFEV as a continued backbone of treatment, where hopefully our inhaled version will make a pivotal moment for patients living with IPF.

當我想到 OFEV 時，這個機會有可能幫助 IPF 患者有一個更容易忍受的選擇，更不用說如果我們能看到更好的療效，那就太棒了。這是一個 40 億美元的市場，並且不斷增長，許多新穎的創新即將到來，我們 OFEV 作為治療的持續支柱，希望我們的吸入版本將為 IPF 患者帶來關鍵時刻。

And then, we upgraded our Boston R&D footprint recently. As you may know, we have a site in Marlborough. That lease will be ending in early '26, and we now have moved into a new facility here in Bedford, Massachusetts, where we have brand new R&D space, expanded our DPI technology platform, and we'll be consolidating our employees between the two sites over the coming 12 months. We're excited for that in terms of recruiting talent and continuing to have more capacity to do more research programs as we go forward.

然後，我們最近升級了波士頓研發基地。如您所知，我們在馬爾堡設有一個站點。租約將於26 年初結束，我們現在已搬進馬薩諸塞州貝德福德的新工廠，在那裡我們擁有全新的研發空間，擴大了我們的DPI 技術平台，並且我們將在這兩家公司之間整合我們的員工未來 12 個月的網站。我們對招募人才以及繼續擁有更多能力開展更多研究計畫感到興奮。

When it comes to Tyvaso DPI, this has been a great opportunity, not only for us, but for patients and United Therapeutics. It's transformed our company and has enabled us to execute our long-term growth strategy of funding our pipeline and continue to be a self-sustaining company.

就 Tyvaso DPI 而言，這不僅對我們、對患者和 United Therapeutics 來說都是一個絕佳的機會。它改變了我們的公司，使我們能夠執行為管道提供資金的長期成長策略，並繼續成為一家自給自足的公司。

As you can see here, for every 10,000 patients reimbursed, this is between $300 million and $350 million in total revenue to MannKind, between royalties and manufacturing revenue. We will anxiously await the TETON-1 and 2. We also will be starting to pay closer attention to the TETON-PPF study, as that comes forward and we see these readouts, starting in the second half of 2025.

正如您在此處所看到的，對於每 10,000 名患者報銷，MannKind 的總收入介於 3 億至 3.5 億美元之間，介於特許權使用費和製造收入之間。我們將焦急地等待 TETON-1 和 2。我們也將開始更密切地關注 TETON-PPF 研究，隨著研究的進展，我們將從 2025 年下半年開始看到這些讀數。

When it comes to endocrine, we've always known when you look at innovation in diabetes, especially type-1, it starts with kids. The parents will fight for the children. The doctors are more cutting edge. And we believe the payers will find an opportunity to cover Afrezza in a more reasonable way and give patients the opportunity to control their sugars.

說到內分泌，我們一直都知道，當你專注於糖尿病（尤其是第 1 型糖尿病）的創新時，首先要從兒童開始。父母會為了孩子而奮鬥。醫生更先進。我們相信付款人會找到機會以更合理的方式承保 Afrezza，並讓患者有機會控制血糖。

The pediatrics is where we look at when you think about drugs that have been on the market for a long time and transforms, whether that's the insulin pumps that (inaudible) built, Omnipod, or CGM Dexcom, that all type-1s use now standard of care. All these innovations started with kids.

當你想到已經上市很長時間並發生變化的藥物時，我們會關注兒科，無論是（聽不清楚）製造的胰島素幫浦、Omnipod 還是 CGM Dexcom，現在所有 1 型藥物都使用標準的照顧。所有這些創新都是從孩子開始的。

And look at even GLPs today, these have been on the market nearly 20 years before we saw the inflection we've seen over the last several years in the weight loss category and why the adoption of GLPs. I know it's frustrating for all of us to think about we sit on with diabetes and endocrine but we are just now at the pivotal moment of new data coming out along with hopefully the ability to transform our future.

即使看看今天的 GLP，這些產品已經上市近 20 年了，我們才看到過去幾年減肥類別的變化以及為什麼採用 GLP。我知道，一想到我們還患有糖尿病和內分泌問題，我們所有人都會感到沮喪，但我們現在正處於新數據發布的關鍵時刻，同時也有望改變我們的未來。

I'm going to stop there and we'll answer any questions. And just so everyone knows, we have several upcoming scientific and investor conferences where you'll get lots of new information or updated questions and oral presentations here in the coming months.

我就到此為止，我們將回答任何問題。眾所周知，我們即將舉行幾場科學和投資者會議，在接下來的幾個月裡，您將在這裡獲得大量新資訊或更新的問題和口頭演示。

Thank you.

謝謝。

(Operator Instructions) Olivia Brayer, Cantor.

（操作員說明）Olivia Brayer，Cantor。

Hey, good morning, guys. Thank you for the questions. How are you thinking about IP and just revenue runway for your two pipeline candidates? And can you just remind us how well protected your Technosphere technology is?

嘿，早上好，夥計們。謝謝你的提問。您如何看待兩個候選管道的智慧財產權和收入跑道？您能否提醒我們您的 Technosphere 技術受到的保護有多好？

And then on the 201 update that we'll get in the fourth quarter, can you give any more color on how many patients worth of data you expect to have and just how you're thinking about next steps once you do have those healthy volunteer data in hand?

然後，在我們將在第四季度獲得的 201 更新中，您能否進一步說明您期望獲得多少患者的數據，以及一旦您擁有這些健康志願者，您將如何考慮下一步行動手裡有數據嗎？

Sorry, I heard the IP question. And then, there's a second one. Then there's the data in hand with IPF. Is that what you said? I missed the second part.

抱歉，我聽到 IP 問題了。然後，還有第二個。然後是 IPF 手中的數據。是你說的嗎？我錯過了第二部分。

Yeah. Why don't we start with IP, Mike, and then I can follow up with 201.

是的。為什麼我們不從 IP 開始，Mike，然後我可以跟進 201。

Sure. So on the IP landscape with -- I think, it was Technosphere as probably your second question. So Technosphere goes out into the 2030. IP on Tyvaso with pending plus, what we have is probably another 2040-ish timeframe, 2043. And then the clofazimine will have QIDP and orphan designation, as well as additional IP filed, so that looks to be 2039, 2040. And then same thing with IPF and the TETON that we look to have into the late 2030s.

當然。因此，在智慧財產權領域——我認為，技術圈可能是你的第二個問題。因此，技術圈將進入 2030 年。Tyvaso 上的 IP 有懸而未決的加號，我們所擁有的可能是另一個 2040 年左右的時間框架，即 2043 年。然後氯法齊明將獲得 QIDP 和孤兒藥指定，以及額外的智慧財產權申請，所以看起來是 2039 年、2040 年。我們預計 2030 年代末期的 IPF 和 TETON 也會出現同樣的情況。

So we feel pretty good about the overall IP of the company going into the next decade and a half or so. And that's assuming we don't do any innovation right. And so, I think there is definitely things we're going to work on now to continue to innovate and make our products easier for patients to take. So we feel pretty good about the next, you know, 7, 8, 10, years as you as far as we can look out in terms of no major IP risk

因此，我們對公司未來十五年左右的整體智慧財產權感到非常滿意。這是假設我們沒有正確進行任何創新。因此，我認為我們現在肯定要努力繼續創新，讓我們的產品更容易為患者服用。因此，我們對未來 7 年、8 年、10 年感覺非常好，因為我們可以預見不會有重大智慧財產權風險

Okay, understood. And then, yeah, just second question was around 201, and the data that we get in 4Q, just any color on how many patients worth of data that you guys will have? And then obviously, just thoughts around next steps for that program going into 2025.

好的，明白了。然後，是的，第二個問題是在 201 左右，我們在第四季度獲得的數據，關於你們將擁有多少患者數據的任何顏色？顯然，我們只是考慮該計劃到 2025 年的後續步驟。

Yeah. So we have completed the first three dosing cohorts, which was single doses, dose escalation up to a max dose we're looking for. Having to report no major findings so far, they're still going through the safety but nothing appears to be getting in our way to go into the multiple sending dose, which will be the next phase, and that'll happen over the next month. And then they'll take some time to analyze those results. So we expect that in Q4.

是的。因此，我們已經完成了前三個給藥組，即單劑量、劑量遞增直至我們正在尋找的最大劑量。到目前為止，還沒有報告任何重大發現，他們仍在進行安全檢查，但似乎沒有什麼能妨礙我們進入多次發送劑量，這將是下一階段，這將在下個月發生。然後他們會花一些時間來分析這些結果。所以我們預計在第四季。

What we'll be looking for is obviously cough tolerability, bronchospasm, anything around that lung administration, GI toxicity, or tolerability. You know that we see any GI side effects in those patients, especially in the multiple sending dose. And then with those results, we plan to go to the FDA with a Phase 2/3 design, which we're still finalizing, that's why I've not shared any details. And we'll hopefully see the FDA agree that type of a study design.

我們要尋找的顯然是咳嗽耐受性、支氣管痙攣、肺部給藥相關的任何情況、胃腸道毒性或耐受性。您知道，我們在這些患者中發現了任何胃腸道副作用，尤其是在多次給藥時。然後根據這些結果，我們計劃向 F​​DA 提交 2/3 期設計，我們仍在最終確定，這就是為什麼我沒有分享任何細節。我們希望看到 FDA 同意這種類型的研究設計。

We've seen in some of the other competing programs here in IPF, but that's our intent. And hopefully, that would get us to market right around when OFEV patent would expire. And so that's what we're kind of looking -- trying to work backwards and make sure we're on time that we can be.

我們已經在 IPF 的其他一些競爭項目中看到過，但這就是我們的意圖。希望這能讓我們在 OFEV 專利到期時立即上市。這就是我們所希望的——努力向後工作並確保我們能夠準時完成。

Thomas Smith, Leerink Partners.

托馬斯史密斯，Leerink 合夥人。

Hey, guys. Good morning. Thanks for taking the questions. Just with respect to the ICoN-1 Phase 3 design, just wondering if you could comment on the powering assumptions for the six month primary endpoint and then for the interim analysis. It sounds like this is mostly a sample size re-estimation, but can you comment on whether there's any early stopping criteria built into this interim either for futility or superiority?

嘿，夥計們。早安.感謝您提出問題。就 ICoN-1 第 3 階段設計而言，只是想知道您是否可以對六個月主要終點以及中期分析的動力假設發表評論。聽起來這主要是樣本量的重新估計，但是您能否評論一下在此期間是否內置了任何早期停止標準，無論是徒勞還是優越？

Sure. I missed your question on the assumption of six months, sorry.

當然。我假設六個月後錯過了你的問題，抱歉。

Yes. Just asking about the power and assumptions on the six month end point, what you've assumed in terms of placebo response and treatment effect?

是的。只是詢問六個月終點的功效和假設，您對安慰劑反應和治療效果的假設是什麼？

Yeah. So what I say is, when we -- in the design of ICoN-1, we benchmarked as best we could in refractory population for a delta of what we saw in our case for factory population. So if it comes out better than that or placebo is not as good, you know that that all will benefit us. It is a dual primary endpoint in the US, meaning our co-primary endpoint, I'll say, in terms of quality of life plus sputum. The rest of the world will be sputum only. So it'll be the same trial used with two different statistical plans.

是的。所以我想說的是，當我們在 ICoN-1 的設計中，我們盡可能地對難以控制的人口進行了基準測試，以獲得我們在工廠人口案例中看到的增量。因此，如果結果比這更好，或者安慰劑沒有那麼好，你知道這一切都會使我們受益。這是美國的雙重主要終點，我想說的是，我們的共同主要終點是生活品質加上痰。世界其他地方將只剩下痰。因此，這將是同一個試驗使用兩個不同的統計計劃。

And the interim analysis is on 100 patients that will have a futility assessment but not a superiority assessment in terms of shutdown as of my knowledge. I know we have different numbers we need to treat if we feel like we're not powered appropriately, we can increase the powering of the study by increasing the patient numbers. So those are the key attributes we've tried to do, depending on which end point is looking, how they're looking in terms of quality of life versus sputum. So that's all predefined in the statistical plan.

據我所知，中期分析針對的是 100 名患者，這些患者將進行無效評估，但不會進行關閉方面的優越性評估。我知道我們需要治療的人數不同，如果我們覺得我們的動力不足，我們可以透過增加患者數量來增加研究的動力。因此，這些是我們嘗試做的關鍵屬性，取決於所關注的終點，以及它們在生活品質與痰液方面的表現如何。這都是統計計劃中預先定義的。

And I think it's 90% powered, but I need to double check that and confirm with you -- get back to you, but I'm not pretty sure it's 90% powered.

我認為它的電量為 90%，但我需要仔細檢查並與您確認 - 回复您，但我不太確定它的電量是否為 90%。

Got it. That makes sense. And then just one on Afrezza. I was wondering if you could just comment on some of the feedback you've been hearing coming out of ADA with the INHALE-3 results, I guess, reception to the dataset and how you think about translating these data and INHALE-1 data to sales growth. Are these data sets you think could potentially impact 2025 prescribing? Or is that more of a longer-term dynamic?

知道了。這是有道理的。然後是 Afrezza 上的一張。我想知道您是否可以對您從 ADA 聽到的 INHALE-3 結果的一些反饋發表評論，我想，對數據集的接受以及您如何考慮將這些數據和 INHALE-1 數據轉化為銷售增長。您認為這些資料集可能會影響 2025 年的處方嗎？或者這更像是一個長期動態？

Yeah, I think, so far, the feedback has been very positive of those that attended ADA and listened to our data, watched our data. The data has been prepared for publication. The first dose just got published in Diabetes Care. So I'd say overall receptivity has been very positive. The team had a small ad board at ADA just to get initial reactions, again, continued demonstrates increased confidence.

是的，我認為，到目前為止，參加 ADA 並聽取我們的數​​據、觀看我們的數據的人的反饋非常積極。數據已準備好發布。第一劑藥物剛發表在《糖尿病照護》雜誌。所以我想說整體接受度非常正面。團隊在 ADA 設立了一個小型廣告板，只是為了獲得初步反應，這再次證明了信心的增強。

And we just got back to research last week, which I couldn't get in time for the earnings call, unfortunately. But that also signals that amongst our highest writers and with our highest target values that they are possibly receiving to data as well. So far, all looks really good in terms of ability to impact future growth of Afrezza.

我們上週剛重新開始研究，不幸的是，我無法及時參加財報電話會議。但這也表明，在我們最高的作家和具有最高目標值的人中，他們也可能會收到數據。到目前為止，就影響 Afrezza 未來成長的能力而言，一切看起來都非常好。

Will that happen in a dramatic way this year? Probably a little bit in Q4 as things roll on Q3 and the data gets published, but realistically, it will be 2025. And what I say about Afrezza, it's a direct reflection of our investment, meaning we've run the brand for profitability last year. And that's been able to -- while we wait for data readouts and then make the decision to scale up and invest more.

今年這種情況會以戲劇性的方式發生嗎？隨著第三季的進展和數據的發布，第四季可能會有一點，但實際上，那將是 2025 年。我對 Afrezza 的評價是我們投資的直接反映，這意味著我們去年經營該品牌是為了獲利。當我們等待數據讀出，然後做出擴大規模和投資更多的決定時，這是能夠做到的。

So if we want to grow it faster, it's going to probably take more investment and just how much faster will that grow relative to the investment we make and those are some of the work we're doing before we scaled any investments so we can communicate appropriately to shareholders what we want to do. But I think right now, the data is good enough to continue to drive increased growth quarters as we go out.

因此，如果我們想要更快地成長，可能需要更多的投資，相對於我們所做的投資，投資的成長速度會快多少，這些是我們在擴大投資規模之前所做的一些工作，以便我們能夠進行溝通適當地向股東展示我們想做的事情。但我認為，目前的數據足以繼續推動我們走出去的季度成長。

And then pediatric, obviously, is in Q4, and that will be more important in terms of really inflection trends, I'll call it, meaning we can grow 20% versus 24%. That's not going to get anybody excited, but if we think we can grow high-double digits through peds launch, that's going to be what's important at the end. And having that data in Q4 with a filing hopefully early next year, that will set us up for early '25, early '26 time frame for PEDS inflection. So I think that's what you'll probably see is my guess. But again, we're conducting additional research and insights. It has some confidence before we make any big decisions here.

然後，顯然，兒科在第四季度，這在真正的變化趨勢方面更為重要，我稱之為，這意味著我們可以成長 20% 與 24%。這不會讓任何人感到興奮，但如果我們認為我們可以透過 peds 的發布實現高兩位數的成長，那麼這將是最後重要的事情。第四季的數據預計在明年初提交，這將為我們在 25 年初、26 年初的 PEDS 拐點時間框架做好準備。所以我想你可能會看到的是我的猜測。但同樣，我們正在進行更多的研究和見解。在我們在這裡做出任何重大決定之前，它有一定的信心。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎（Gregory Renza），加拿大皇家銀行資本市場部。

Great. Good morning, Mike and Chris. Congrats on the -- on the quarter. Thanks for taking my question.

偉大的。早上好，麥克和克里斯。恭喜本季。感謝您提出我的問題。

Mike, maybe just keeping with 101, clofazimine inhalation, just curious as you and the team activate sites and stand up the trial, if you had any feedback, and maybe touch on how sort of the activation and the entrenchment of sites is shaping your confidence in the program and the value proposition that you see with 101?

麥克，也許只是繼續關注 101，氯法齊明吸入劑，只是好奇您和團隊激活站點並經受住考驗，如果您有任何反饋，也許會觸及站點的激活和鞏固如何塑造您的信心您認為101 的計劃和價值主張是什麼？

Yeah, I think it's true like, Greg, you know, the team has been to about 10 sites. August will slow down a little bit for site activation just due to vacations and holidays, but they expect that to pick up a lot here in September. We already know they're pre-screening patients, a couple already scheduled for August.

是的，我認為這是真的，格雷格，你知道，團隊已經去過大約 10 個地點。由於假期和假日的原因，8 月的網站啟動速度會稍微放緩，但他們預計 9 月的網站啟動速度會大幅增加。我們已經知道他們正在對患者進行預篩檢，其中一對夫婦已經安排在八月進行篩檢。

So I think it's only one month in. I wouldn't try to read too much positive or negative into it. I'd say so far, the feedback has been generally positive, as we all suspect you know, how big is this refractory population? How quickly can we get to naive patients? How quickly can we move the dry powder along? These are things we're working on, as we know that's the much bigger population to go after.

所以我認為只有一個月的時間。我不會試著解讀太多正面或負面的內容。我想說，到目前為止，回饋總體上是正面的，正如我們都懷疑的那樣，這個難治人群有多大？我們能多快接觸到初治患者？我們能夠以多快的速度移動乾粉？這些是我們正在努力解決的問題，因為我們知道需要關注的人口要多得多。

But I think in terms of enrollment trial in the US and Asia Pacific area, there are enough patients to get that moving, enough patients to get hopefully ready for a good launch. But the real opportunity is obviously the larger NTM population, but getting this trial moving is the first step into that foray.

但我認為，就美國和亞太地區的入組試驗而言，有足夠的患者來推動這一進展，有足夠的患者為良好的啟動做好準備。但真正的機會顯然是更大的 NTM 人群，但推動這項試驗是進軍這一領域的第一步。

But we continue to watch our case do well. That makes us feel very good about the bets here. And the market affiliate has no options. I mean, so this is really exciting for patients. It's exciting for the treaters. It's exciting for the FDA, as well as our employees. We worked really hard to get here. And from manufacturing standpoint, we'll be ready. And the trial I think is going -- got a lot of interest from the top investigators. So we feel pretty good about the sites that we're getting in the patients that we'll be recruiting very shortly.

但我們繼續觀察我們的案件進展順利。這讓我們對這裡的投注感覺非常好。市場附屬公司別無選擇。我的意思是，這對患者來說真的很令人興奮。這對治療師來說是令人興奮的。這對 FDA 以及我們的員工來說都是令人興奮的。我們非常努力才來到這裡。從製造的角度來看，我們會做好準備。我認為正在進行的試驗引起了頂級調查人員的極大興趣。因此，我們對我們在很快將招募的患者中獲得的位點感覺非常好。

Got it. I think at the top of the call Mike you mentioned expanded access and maybe more to come. Just touch a little bit about that, maybe some of the timing, and some of the inputs there. Thanks and congrats again on the quarter.

知道了。我認為麥克在電話會議的頂部提到了擴大訪問權限，也許會有更多內容。只需稍微了解一下這一點，也許是一些時間安排，以及那裡的一些輸入。再次感謝並恭喜本季。

Thank you, Greg. Yeah, so I've asked the team to look -- to see if there is a way to get the EAP with the FDA sooner than later, and maybe that EAP would be for patients who don't qualify for the trial and would the FDA allow us to provide access given there's only one treatment option out there. We don't have clarity on that yet. We've not approached the FDA yet. But that's really -- the key part of that comment is if we could find a way to help more people sooner that don't qualify for the trial, we would be interested in that.

謝謝你，格雷格。是的，所以我已經要求團隊看看是否有辦法儘早向 FDA 獲得 EAP，也許 EAP 適合那些不符合試驗資格的患者，並且鑑於只有一種治療選擇，FDA 允許我們提供訪問權限。我們對此還不清楚。我們還沒有聯繫 FDA。但這確實是 - 該評論的關鍵部分是，如果我們能夠找到一種方法來更快地幫助更多不符合試驗資格的人，我們會對此感興趣。

Obviously, we don't want to have an EAP enrollment for the trial that would delay our ability to help get that trial recruited. So that'll be some of the focus here is can we find a way to help those patients. But that'll be in collaboration, but the FDA may want a certain amount of patients first. We'll have to see where they land.

顯然，我們不希望 EAP 註冊參加該試驗，這會延遲我們幫助招募該試驗的能力。因此，這裡的重點是我們能否找到一種方法來幫助這些患者。但這將是合作的，但 FDA 可能首先需要一定數量的患者。我們得看看他們在哪裡著陸。

Brandon Folkes, Rodman & Renshaw.

布蘭登福克斯、羅德曼和倫肖。

Maybe just two for me, Mike, I know you said you can't talk too much about the potential Phase 2/3 trial in 201, but would you be able to just talk about maybe if you're considering multiple dose levels there, and just elaborate on what is first prize for you in this program? Is it something that's comparable on efficacy with better GI side effects? Or would you prioritize, perhaps, sort of a potentially more efficacious drug here?

也許對我來說只有兩個，麥克，我知道你說過你不能過多談論 201 年潛在的 2/3 期試驗，但是如果你正在考慮那裡的多個劑量水平，你是否可以只談論也許，請詳細說明一下您在這個專案中獲得的一等獎是什麼？它的功效與胃腸道副作用相比是否具有可比性？或者您會優先考慮一種可能更有效的藥物嗎？

And then secondly, just maybe on Tyvaso DPI, can you just talk about the manufacturing capacity where you're at today, what needs to be done if TETON is successful? And just how much investment does that take? Thank you.

其次，也許在 Tyvaso DPI 上，您能談談您今天的製造能力嗎？這需要多少投資？謝謝。

Sure. I'll take the second one first, because that's easy. So from a DPI manufacturing capacity, we've been able to build up substantial amount of inventory for United Therapeutics this year. We should be well on our way ahead of any TETON results in terms of scale and capacity, we don't see any limitations, as far as we can see with that approval.

當然。我會先選擇第二個，因為這很容易。因此，從 DPI 製造能力來看，我們今年已經能夠為 United Therapeutics 建立大量庫存。在規模和容量方面，我們應該遠遠領先 TETON 的任何結果，就我們所看到的批准而言，我們沒有看到任何限制。

The investment in the plant has already been invested in by United Therapeutics. All the equipment's been installed and purchased, so there's no additional investment. That's a major. I'm sure it'll be small things here and there, but nothing that's significant for shareholders or for United Therapeutics at this point.

該工廠的投資已由 United Therapeutics 投資。設備已全部安裝、採購完畢，無需額外投資。那是一個專業。我確信這會是一些小事情，但目前對股東或聯合治療公司來說沒有什麼重要的。

That doesn't account for what UT may do independently MannKind, i.e. building their own plant that's a separate decision on their part. But as far as we're concerned, we'll be able to supply substantial amount of DPIs as we go forward.

這並沒有考慮到 UT 可能獨立為 MannKind 所做的事情，即建造自己的工廠，這是他們單獨決定的。但就我們而言，隨著我們的發展，我們將能夠提供大量的 DPI。

In terms of, what does a win look like, it's a great question. And we've had this internal debate ourselves in that. Do we really want to demonstrate the safety side of this around the severe GI tolerability issues that happen? Is it important to try to go after increased efficacy or is it a balance of both of those by getting to market as quick as we can? And I think that trick triangle in terms of efficacy, speed, and tolerability is something we're continuing to talk about and there's various ways you can design a Phase 2/3 trial to build those attributes.

就勝利而言，這是一個很好的問題。我們自己也對此進行了內部辯論。我們真的想圍繞發生的嚴重胃腸道耐受性問題來證明其安全性嗎？努力提高功效是否重要，還是透過盡快進入市場來平衡兩者？我認為我們將繼續討論功效、速度和耐受性方面的三角技巧，並且您可以透過多種方式設計 2/3 期試驗來建立這些屬性。

And the question is how fast can you get to market and help those patients? And what do you need to demonstrate? For example, if we were to demonstrate equal efficacy somehow, but you took existing patients on the (inaudible), you may not see the GI benefit as much maybe you'll see people take less Imodium or feel quite a lot better. But you could also study in naive patients, where you'll see, hopefully, a large benefit in tolerability, which could be a huge benefit to outcomes and efficacy.

問題是您能多快進入市場並幫助這些患者？你需要展示什麼？例如，如果我們要以某種方式證明相同的功效，但你讓現有患者服用（聽不清楚），你可能不會看到那麼多的胃腸道益處，也許你會看到人們服用較少的易蒙停或感覺好多了。但您也可以在初次接受治療的患者中進行研究，希望您會看到耐受性方面的巨大優勢，這可能對結果和療效產生巨大的好處。

Or you can go after higher dosing, which could generate potential better efficacy. But how much more, we don't know. And that's all the questions we have for ourselves, as much as anything. And so because we are going into a Phase 2/3 design, that does limit some of our forecastability on efficacy, for example.

或者您可以追求更高的劑量，這可能會產生更好的療效。但還有多少，我們不知道。這就是我們對自己的所有問題。因此，因為我們即將進入 2/3 階段設計，這確實限制了我們對功效的一些預測能力。

But let's see the first readout here in this Phase 1, make sure patients can tolerate our target doses, and then we will you finalize that trial design. We're also meeting some thought leaders here in coming weeks and months to triangulate this exact question, but we have an idea of what we want to do, and we just want to bounce that off with some investigators before we come out and talk about it publicly.

但是，讓我們看看第一階段的第一個讀數，確保患者能夠耐受我們的目標劑量，然後我們將幫助您最終確定試驗設計。我們還將在未來幾週和幾個月內與一些思想領袖會面，以三角測量這個確切的問題，但我們知道我們想要做什麼，我們只是想在我們出來討論之前與一些調查人員進行討論公開它。

And then you were asking, do we want to go after dosing and multiple doses? There's a strategy that could be two different doses and study them, or could be a titrate up dose effect, like you see in a (inaudible) type design, where you try to titrate to the highest level dose. So those are the things we are looking at, and they all have pros and cons, Brandon, so no magic answer here, but other than, we want to give this drug to patients as quickly as possible. And I think once we get on the market, then we can innovate even from there in terms of demonstrating additional trial outcomes, et cetera. So we'll get there, but let's get through the first step here. I think that's the most important, and then be with FDA.

然後你問，我們是否要繼續給藥和多次給藥？有一種策略可以是兩種不同的劑量並研究它們，或者可以是滴定劑量效應，就像您在（聽不清楚）類型設計中看到的那樣，您嘗試滴定到最高水平劑量。這些就是我們正在關注的事情，它們都有優點和缺點，布蘭登，所以這裡沒有神奇的答案，但除此之外，我們希望盡快將這種藥物提供給病人。我認為一旦我們進入市場，我們甚至可以在展示額外的試驗結果等方面進行創新。我們會到達那裡，但讓我們完成第一步。我認為這是最重要的，然後是 FDA。

That concludes today's question and answer session. I'd like to turn the call back to Michael Castagna for closing remarks.

今天的問答環節到此結束。我想將電話轉回給邁克爾·卡斯塔尼亞（Michael Castagna），讓他致閉幕詞。

I just want to say thank you to everyone. It's been a fantastic year, a volatile year for all of us, but the company is in a great spot. We're looking to close out the year strong and really get ready for '25 and '26 as we look at multiple data readout from a clinical side across our entire platform and programs as well as upside into the in-line revenue that we're driving with the diabetes business. So we feel very good about the future.

我只想對大家說聲謝謝。這是美好的一年，對我們所有人來說都是動蕩的一年，但公司處於一個很好的位置。我們希望以強勁的勢頭結束這一年，並真正為“25”和“26”做好準備，因為我們著眼於整個平台和項目的臨床方面的多個數據讀數，以及我們的在線收入的上升空間。所以我們對未來感覺非常好。

Hopefully, I'll have some news on international expansion as we go forward for Afrezza and continue to drive growth and help more patients. I just want to say thank you to all of our employees for all the hard work and all the shareholders for all your support. Have a great day.

希望隨著我們繼續推進 Afrezza 並繼續推動成長並幫助更多患者，我能獲得一些有關國際擴張的消息。我只想對我們所有員工的辛勤工作和所有股東的支持表示感謝。祝你有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。