MannKind Corp (MNKD) 2022 Q4 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon, and welcome to the MannKind Corporation 2022 Fourth Quarter and Full Year Financial Results Earnings Call. As a reminder, this call is being recorded on February 23, 2023, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until March 9, 2023.

    下午好,歡迎來到 MannKind Corporation 2022 年第四季度和全年財務業績收益電話會議。提醒一下,本次通話將於 2023 年 2 月 23 日進行錄音,本次通話結束後不久將可在 MannKind Corporation 網站上播放,直至 2023 年 3 月 9 日。

  • 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 their 10-K report filed with the Securities and Exchange Commission this afternoon, the earnings release and the slides prepared for this presentation.

    此電話會議將包含前瞻性陳述。此類前瞻性陳述受風險和不確定因素的影響,可能導致實際結果與陳述的預期存在重大差異。有關公司風險因素的更多信息,請參閱他們今天下午向美國證券交易委員會提交的 10-K 報告、收益發布以及為本次演示準備的幻燈片。

  • Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Steven Binder. I would now like to turn the call over to Mr. Castagna. Please go ahead, sir.

    今天從 MannKind 加入我們的是首席執行官 Michael Castagna;和首席財務官 Steven Binder。我現在想把電話轉給卡斯塔尼亞先生。請繼續,先生。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Thank you, Lisa, and thank you, everyone, for joining us today. As we kick off, it was 7 years ago this weekend that I decided to join MannKind and unfortunately, 7 years since Alfred Mann passed away. It's been an amazing journey and one that was harder than anyone could have imagined. 2023 is special because it's the beginning of our new future growth plan. We have overcome every obstacle that was thrown our way [and went] against us. We are still capitalized and prepared to enter our next phase of growth, and I want to personally thank all of our employees, our stock and debt holders, demand foundation trustees and other stakeholders who support us through this journey. Our best years are in front of us. I'm very excited to kick off our Q4 earnings call today.

    謝謝你,麗莎,也謝謝大家今天加入我們。當我們開始時,7 年前的這個週末,我決定加入 MannKind,不幸的是,阿爾弗雷德·曼 (Alfred Mann) 去世已經 7 年了。這是一段了不起的旅程,而且比任何人想像的都要艱難。 2023 年很特別,因為它是我們新的未來增長計劃的開始。我們已經克服了阻礙我們前進的每一個障礙。我們仍然資本充足,並準備進入下一階段的增長,我要親自感謝我們所有的員工、我們的股票和債務持有人、需求基金會受託人和其他利益相關者,他們在這一過程中支持我們。我們最好的年華就在眼前。我很高興今天開始我們的第四季度財報電話會議。

  • To remind people that our mission is to give people control of their health and the freedom to live life, and we refer to this as life more humann. This has never been more true as we get right into (inaudible) of the patient stories we hear from Tyvaso DPI's launch or the incredible feedback we get from V-Go as well as Afrezza. Every day, we are making people's lives more human and easier to live.

    提醒人們我們的使命是讓人們控制自己的健康和自由地生活,我們將此稱為更人性化的生活。當我們直接了解(聽不清)我們從 Tyvaso DPI 的發布中聽到的患者故事或我們從 V-Go 和 Afrezza 獲得的令人難以置信的反饋時,這從未像現在這樣真實。每一天,我們都在讓人們的生活更人性化、更輕鬆。

  • 2022 was a revolutionary year for MannKind. If you look back at this time last year, we had 1 marketed product, we were facing a delay in FDA approval for Tyvaso DPI, one compound in clinical trials, which was Afrezza for INHALE-1 had just started and the commercial revenue stream was just Afrezza.

    2022 年對 MannKind 來說是革命性的一年。如果你回顧一下去年的這個時候,我們有 1 個上市產品,我們面臨 FDA 對 Tyvaso DPI 的批准延遲,這是一種臨床試驗中的化合物,即用於 INHALE-1 的 Afrezza 剛剛開始,商業收入流是只是阿弗雷扎。

  • As we end the year, we technically have 3 marketed products, 2 that we market and 1 that's marketed by United Therapeutics, 2 compounds in clinical trials with Afrezza INHALE-1 being halfway rolled out and MNKD-101 kicking off to completing Phase I, and 4 commercial revenue streams. As we look, this is a revolutionary milestone in the history of the company as we're approaching $100 million exiting 2022. Steve will talk about how that translates to the run rate as we go into 2023 and beyond.

    今年年底,我們在技術上有 3 種上市產品,2 種我們銷售,1 種由 United Therapeutics 銷售,2 種化合物正在進行臨床試驗,Afrezza INHALE-1 已推出一半,MNKD-101 開始完成 I 期,和 4 個商業收入來源。正如我們所看到的,這是公司歷史上的一個革命性里程碑,因為我們將在 2022 年結束時接近 1 億美元。史蒂夫將討論這將如何轉化為我們進入 2023 年及以後的運行率。

  • When you take a step back, our collaboration royalties are up 20% versus last year. Our endocrine business was up 44% versus last year. These 3 new revenue sources are going to generate the capital required to continue to fund our growth and drive a difference for patients across the disease states that we're servicing.

    退一步說,我們的合作版稅比去年增加了 20%。我們的內分泌業務比去年增長了 44%。這 3 個新的收入來源將產生所需的資金,以繼續為我們的增長提供資金,並為我們所服務的疾病狀態的患者帶來改變。

  • It's really exciting to look at Tyvaso DPI's [early stages] with United Therapeutics. When you look back a repeat quarter of last year, this has continued to be revolutionary as we go through those phases of launch. So in the first quarter to early 3Q, we were just getting some of the SKUs off the market, just getting this off the ground with United Therapeutics. And in Q4, you can see collaboration of services revenue is relatively flat, but the royalty revenue continues to grow.

    與 United Therapeutics 一起研究 Tyvaso DPI 的[早期階段]真的很令人興奮。當你回顧去年的重複季度時,隨著我們經歷這些發布階段,這仍然是革命性的。所以在第一季度到第三季度初,我們只是讓一些 SKU 退出市場,只是通過 United Therapeutics 將其付諸實踐。而在第四季度,你可以看到合作服務收入相對持平,但特許權使用費收入繼續增長。

  • And the reason that's important is that the collaboration of services revenue is relatively fixed as we continue to increase volume and productivity out of the factory, but the royalty should continue to grow. So that's something to keep in mind as we look -- it will fluctuate minor from quarter-to-quarter, but not dramatically different as we go forward.

    重要的原因是,隨著我們繼續增加工廠外的產量和生產率,服務收入的協作相對固定,但特許權使用費應該繼續增長。因此,在我們看來,這一點要牢記在心——每個季度都會有小幅波動,但在我們前進的過程中不會有太大的不同。

  • The EBU business and gross profit accelerated in 2022. When you look at our net revenue, it grew 44% and that dropped to the bottom line with almost 80% growth here from $22 million to $40 million in gross profit on the endocrine business unit. The reason this is important, we did this without any increase in COGS despite adding V-Go into our company and the cost associated with V-Go. We've been able to keep COGS relatively flat and every incremental dollar starts to drop to the bottom line. We'll continue to look for efficiency as we look at combining this business and driving future revenue growth. Additionally, we had a small primary care pilot last year, which didn't go as planned and we exited that business and that money we spent last year is being repurposed this year to drive future growth in [NPL].

    EBU 業務和毛利潤在 2022 年加速增長。當您查看我們的淨收入時,它增長了 44%,並且下降到底線,內分泌業務部門的毛利潤從 2200 萬美元增長到 4000 萬美元,增長了近 80%。這一點很重要的原因是,儘管將 V-Go 添加到我們公司以及與 V-Go 相關的成本,我們還是在沒有增加 COGS 的情況下做到了這一點。我們已經能夠保持 COGS 相對平穩,每一美元的增量都開始下降到底線。我們將繼續尋求效率,因為我們著眼於合併這項業務並推動未來的收入增長。此外,我們去年進行了一個小型初級保健試點,但沒有按計劃進行,我們退出了該業務,我們去年花費的資金今年將重新用於推動 [NPL] 的未來增長。

  • Let me focus a little bit more on Q4 highlights. When you look at DPI, we had strong patient demand, which supports our manufacturing revenue now and into the future. Our royalty revenue grew 50% versus Q3, and our manufacturing capacity expansion has been in progress since. I was just in Danbury last week taking a tour. The pipeline is moving forward as we have 1 more FDA meeting here 101, and we expect to move this asset into a Phase II/III trial design in the second half of 2023. And we'll share more details sometime during Q2 and Q3.

    讓我多關註一下第四季度的亮點。當你看 DPI 時,我們有強烈的耐心需求,這支持了我們現在和未來的製造收入。與第三季度相比,我們的特許權使用費收入增長了 50%,此後我們的製造能力擴張一直在進行。上週我剛剛在丹伯里參觀。隨著我們在這裡舉行 1 次 FDA 會議 101,管道正在向前推進,我們預計將在 2023 年下半年將該資產轉移到 II / III 期試驗設計中。我們將在第二季度和第三季度的某個時候分享更多細節。

  • We filed a pre-IND meeting request for MNKD-201, and we expect to see a feedback here shortly as we progress nintedanib into a Phase I study. As I look at our diabetes business, Afrezza grew TRx 9% versus '21 and 4% sequentially quarter-to-quarter. As I said, INHALE-1 is on track.

    我們提交了 MNKD-201 的 IND 前會議請求,我們希望在我們將 nintedanib 推進到 I 期研究時很快在這裡看到反饋。當我審視我們的糖尿病業務時,Afrezza 的 TRx 增長了 9%,而 21 年和 4% 連續季度增長。正如我所說,INHALE-1 正在走上正軌。

  • And you just saw yesterday, we announced the Afrezza with Basal combination study showed favorable results in the first dose in office on a meal challenge test, and the full results of this will be presented later this year. But the results we've seen and the analysis we've seen so far have given us the confidence to want to kick off a larger Phase IV study as we really think about how do we capitalize and win on the investments we've already made historically in Afrezza that really position us to be a leader to type 1 diabetes.

    你剛剛在昨天看到,我們宣布 Afrezza 與 Basal 聯合研究顯示,在辦公室的第一劑膳食挑戰測試中取得了良好的結果,其全部結果將在今年晚些時候公佈。但我們所看到的結果和迄今為止所看到的分析讓我們有信心開始一項更大規模的 IV 期研究,因為我們真正考慮的是如何利用和贏得我們已經進行的投資從歷史上看,在 Afrezza,這確實使我們成為 1 型糖尿病的領導者。

  • V-Go had Q4 net revenue of $5.4 million. And we'll show you shortly, we stabilized that business and looking forward to it. We had $173 million in cash and cash equivalents at the end of last year.

    V-Go 第四季度淨收入為 540 萬美元。我們很快就會向您展示,我們穩定了該業務並期待它。截至去年底,我們擁有 1.73 億美元的現金和現金等價物。

  • With the purchase of V-Go and as the competition continues to make way, MannKind is really the mealtime solutions company. Several other insulins have tried to launch over the last 7 years, and they failed to capitalize on their innovation and drive meaningful patient differences.

    隨著 V-Go 的購買和競爭的不斷讓步,MannKind 真正成為了一家用餐時間解決方案公司。在過去的 7 年裡,其他幾種胰島素也曾嘗試推出,但他們未能利用他們的創新來推動有意義的患者差異化。

  • Insulin pump companies have continued to try to drive innovation. And what really happens is patients go from 1 to another pump to a pod, but they're all still struggling with mealtime control. At some point, we believe this product will have been in the market long enough, as it stands the test of time and the new day we have coming out over the 12 months, we believe sets this (inaudible) Afrezza's ability to help and solve the mealtime solution challenge that we have, and V-Go will really allow us help those type 2 patients that much better, and that has also demonstrated improvement that they want to see in quality of life.

    胰島素泵公司不斷嘗試推動創新。真正發生的是,患者從 1 個泵轉到另一個泵再到一個豆莢,但他們仍在努力控制進餐時間。在某個時候,我們相信該產品將在市場上投放足夠長的時間,因為它經受住了時間的考驗,而且我們在 12 個月內推出了新的一天,我們相信這種(聽不清)Afrezza 能夠幫助和解決問題我們面臨的進餐時間解決方案挑戰,而 V-Go 將真正讓我們更好地幫助那些 2 型患者,這也證明了他們希望看到的生活質量改善。

  • Some of the highlights we have for last year is number one, we bolted up our scientific understanding of the Afrezza. The results of these really came out last year or put into last year's work which have really be built over the last 5 years. And so the dosing that we're using in INHALE-1 around the 2x round down was put into our pediatric trial, and we believe that's paying off dividends as we look at the first dose AEC results that were just released yesterday, but really showed you in the first 2 hours when you really care about [glycaemic] control, Afrezza does something amazing versus injectables. And we think that hopefully, it will translate out to dosing over and over for each meal as you look at 3 to 6 to 12 months.

    我們去年的一些亮點是第一,我們加強了對 Afrezza 的科學理解。這些成果真正在去年出來,或者真正投入到去年的工作中,都是過去5年真正建成的。因此,我們在 INHALE-1 中使用的大約 2 倍向下的劑量被用於我們的兒科試驗,我們相信這是有回報的,因為我們看到了昨天剛剛發布的第一劑 AEC 結果,但確實顯示在你真正關心 [血糖] 控制的前 2 小時內,Afrezza 與註射劑相比做了一些驚人的事情。我們認為,在您觀察 3 到 6 到 12 個月時,我們希望它會轉化為每餐一遍又一遍地給藥。

  • The AV trial will come out. Hopefully, we've submitted additional analysis of future conferences, and we've already published the DAS study, which was doubling our package insert dose. Our pediatric study remains on progress, and we'll continue to show you, hopefully, data showing how people can safely switch from an insulin pump to Afrezza. And we've also shown that adding Afrezza to a pump is great, but there's no additional benefit despite people who are adding it will help improve mealtime control.

    AV試用會出來。希望我們已經提交了對未來會議的額外分析,並且我們已經發布了 DAS 研究,該研究使我們的包裝插頁劑量增加了一倍。我們的兒科研究仍在進行中,我們將繼續向您展示希望的數據,顯示人們如何安全地從胰島素泵切換到 Afrezza。我們還表明,將 Afrezza 添加到泵中效果很好,但沒有額外的好處,儘管人們添加它有助於改善進餐時間控制。

  • On Afrezza, we've enhanced our patient support services. We continue to find ways to improve efficiency for patient reimbursement support, and closing that gap on prior authorization friction that happens in the (inaudible). We've worked several years with (inaudible) to ensure that inhalants was included in the Inflation Protection Act, and I'm probably one of the few drug company executives who were supportive of the fact because it really did help patients around insulin and Medicare coverage.

    在 Afrezza,我們加強了患者支持服務。我們繼續尋找提高患者報銷支持效率的方法,並縮小(聽不清)發生的事先授權摩擦的差距。我們已經與(聽不清)合作了幾年,以確保吸入劑被納入《通脹保護法》,我可能是少數支持這一事實的製藥公司高管之一,因為它確實在胰島素和醫療保險方面確實幫助了患者報導。

  • We also improved our product dating, which people may not realize the 36 months from 24 months. And the reason that's important is a good percentage of our gross nets are related to product returns, and we believe over time, as demand picks up and (inaudible) makes sense, that allows returns (inaudible). That will happen for time.

    我們還改進了我們的產品約會,人們可能沒有意識到從 24 個月到 36 個月。重要的原因是我們總淨額的很大一部分與產品退貨有關,我們相信隨著時間的推移,隨著需求的回升和(聽不清)變得有意義,這將允許退貨(聽不清)。那會發生一段時間。

  • On V-Go, we purchased this asset in the second quarter. We may just focus the team [that kept separate] for 2022 as we integrated it into MannKind. And finally, within Q1 of this year, we prepared for that integration, and this is now being launched through our entire Afrezza sales force.

    在 V-Go 上,我們在第二季度購買了這項資產。當我們將其整合到 MannKind 中時,我們可能只關注 2022 年 [保持獨立] 的團隊。最後,在今年第一季度,我們為整合做好了準備,現在正在通過我們整個 Afrezza 銷售團隊推出。

  • One of our key focuses last year was driving market share of new prescriptions. And you can see our NRx growth quarter-over-quarter continued to grow from Q1 through Q4, where we exited with 17% growth year-over-year on NRxs. As I look at just Q1 to date, (inaudible) our for 24% growth over the first 6 weeks, Q1 versus Q1 of this year, we continue to see positive momentum on NRx, which translates to TRxs over time, but this is our leading indicator of how we expect our business to perform.

    去年我們的重點之一是推動新處方的市場份額。你可以看到我們的 NRx 環比增長從第一季度到第四季度持續增長,我們在 NRxs 上以 17% 的同比增長退出。當我只看迄今為止的第一季度時,(聽不清)我們在前 6 週增長了 24%,與今年第一季度相比,我們繼續看到 NRx 的積極勢頭,隨著時間的推移轉化為 TRx,但這是我們的我們期望業務表現的領先指標。

  • As we look at V-Go, again, back to NRxs, you can look, V-Go has been on a real long decline. We purchased this asset in Q2, got it ready in Q3 and stabilized at Q4 on NRx, and we look to -- expect NRxs to grow here in Q1. But most importantly, that will now translate to TRx stabilizing and ultimately growing as we look forward to the rest of this year.

    當我們再次看 V-Go 時,回到 NRxs,你可以看到,V-Go 一直在長期下降。我們在第二季度購買了這項資產,在第三季度準備好並穩定在 NRx 的第四季度,我們期待 - 期望 NRxs 在第一季度在這裡增長。但最重要的是,隨著我們期待今年餘下時間,這將轉化為 TRx 穩定並最終增長。

  • (inaudible) in these 2 products is critical to our success. We've really positioned Afrezza for type 1, younger population, commercial insurance. Even though we now have Medicare, that's great because 20% of our sales are Medicare, 40% of the insulin market is Medicare. But at the end of the day, we want to make sure we continue to win and lead in type 1 diabetes.

    (聽不清)這兩種產品對我們的成功至關重要。我們確實將 Afrezza 定位為第 1 類、年輕人口、商業保險。即使我們現在有 Medicare,這也很棒,因為我們 20% 的銷售額是 Medicare,40% 的胰島素市場是 Medicare。但歸根結底,我們要確保我們在 1 型糖尿病方面繼續取得勝利並處於領先地位。

  • Additionally, we continue to find ways to improve our gross to net by shifting our sales to specialty pharmacy through direct purchase agreements and making sure that patients have a better service when they receive our product. On the V-Go side, it's definitely a type 2 product, older population, which is about 60% Medicare in the case of V-Go. And in 2023, we've now put this in a P2 position for Afrezza and is a potential (inaudible) V-Go territory selling this asset.

    此外,我們繼續尋找方法,通過直接購買協議將我們的銷售轉移到專業藥房,並確保患者在收到我們的產品時獲得更好的服務,從而提高我們的毛淨收入。在 V-Go 方面,它絕對是 2 類產品,老年人口,在 V-Go 的情況下,大約是 Medicare 的 60%。在 2023 年,我們現在將其置於 Afrezza 的 P2 位置,並且是出售該資產的潛在(聽不清)V-Go 領域。

  • As we look over the next 12 to 15 months, there are several key (inaudible) coming out. Number one, we have the kickoff of INHALE-3 really has occurred this week with AATD. We have a BluHale launch, which is really integrating CGM into a technology platform that can attach to the Afrezza device and that will start to read CGM along with (inaudible) and be our first kind of platform as we start to think about how to incorporate AI into our future predictive dosing. This is a 1.0 version, which will continue to grow as we invest in technology behind that diabetes care.

    當我們展望未來 12 到 15 個月時,會出現幾個關鍵(聽不清)。第一,本週 AATD 確實啟動了 INHALE-3。我們推出了 BluHale,它真正將 CGM 集成到一個可以連接到 Afrezza 設備的技術平台中,它將開始與(聽不清)一起讀取 CGM 並成為我們的第一種平台,因為我們開始考慮如何整合人工智能進入我們未來的預測劑量。這是一個 1.0 版本,隨著我們對糖尿病護理背後的技術的投資,它將繼續發展。

  • We expect simply to read out a Phase II trial, which we're calling INHALE-2 type 2 diabetes. And then assuming BluHale, the launch goes well, we should [expect a full launch here] in the second half of the year. We expect the INHALE-1 pediatric study to be enrolled by the end of this year and INHALE-3 to be fully available sometime in the end of the year or early next year, but the readout should follow about 3 months later.

    我們希望簡單地宣讀一項 II 期試驗,我們稱之為 INHALE-2 2 型糖尿病。然後假設 BluHale,發布進展順利,我們應該 [期待在這裡全面發布] 在今年下半年。我們預計 INHALE-1 兒科研究將在今年年底註冊,INHALE-3 將在今年年底或明年初的某個時候完全可用,但讀數應該在大約 3 個月後進行。

  • Now I'm going to turn it over to Steve who's a phenomenal partner with me over the last 6 years. Thank you, Steve.

    現在我要把它交給史蒂夫,他在過去 6 年裡是我的非凡合作夥伴。謝謝你,史蒂夫。

  • Steven B. Binder - CFO

    Steven B. Binder - CFO

  • Thanks, Mike, and good afternoon. I'm pleased to review the select fourth quarter and full year 2022 financial results. Please supplement this call by reading the consolidated financial statements, MD&A contained in our 10-K, which was filed with the SEC this afternoon.

    謝謝,邁克,下午好。我很高興回顧精選的第四季度和 2022 年全年財務業績。請閱讀我們今天下午向美國證券交易委員會提交的 10-K 中包含的合併財務報表、MD&A 來補充此次電話會議。

  • We're very proud of hitting the $100 million mark in total revenues for 2022. It just shows our transition as a company with 1 source of commercial revenue to a company with multiple sources of commercial revenue.

    我們為 2022 年的總收入達到 1 億美元大關而感到非常自豪。這只是表明我們從一家擁有單一商業收入來源的公司轉變為一家擁有多種商業收入來源的公司。

  • Let's start with the fourth quarter (inaudible) table, and then we'll come back to the full year results. Afrezza net revenue was $12 million versus $11.3 million in 2021, a growth rate of 6%. The growth was mainly driven by higher patient demand with underlying peak TRx growth of 9% year-over-year. In previous quarters, I had been discussing the adverse impact of the lowering of post-sale inventory levels, which impacted our revenues for the first 3 quarters of 2022. We can now confirm that we saw the bottom out of this in the third quarter as expected. Year-to-date, Afrezza growth came in at 11%, which was mainly due to favorable price, higher product demand and a more favorable cartridge mix. Our gross to net held steady at 39% year-over-year.

    讓我們從第四季度(聽不清)表開始,然後我們將回到全年結果。 Afrezza 淨收入為 1200 萬美元,而 2021 年為 1130 萬美元,增長率為 6%。這一增長主要是由更高的患者需求推動的,潛在的 TRx 峰值同比增長 9%。在前幾個季度,我一直在討論售後庫存水平下降的不利影響,這影響了我們 2022 年前三個季度的收入。我們現在可以確認,我們在第三季度看到了這種情況的底部,因為預期的。今年迄今為止,Afrezza 的增長率為 11%,這主要是由於優惠的價格、更高的產品需求和更有利的墨盒組合。我們的毛淨值同比穩定在 39%。

  • Next is our net revenue for V-Go, where we had $5.4 million of net revenue for the fourth quarter and $12.9 million for year-to-date, which represents 7 months of June through December. We continue to see V-Go net revenue tracking at the high end of our forecast range of $18 million to $22 million for the 12 months post acquisition.

    接下來是我們 V-Go 的淨收入,我們第四季度的淨收入為 540 萬美元,今年迄今為 1290 萬美元,即 6 月至 12 月的 7 個月。在收購後的 12 個月裡,我們繼續看到 V-Go 的淨收入跟踪在我們預測範圍的高端 1800 萬至 2200 萬美元。

  • Moving to collaboration services. Revenue in the fourth quarter was $9.5 million versus $1.2 million for 2021. The main driver for the fourth quarter 2022 collaboration revenue is associated with the manufacturing of Tyvaso DPI of United Therapeutics while the 2021 revenue was impacted by the end of the amortization of Tyvaso DPI R&D milestones and delaying the FDA approval for the drug, which meant that we had to defer revenue until we could manufacture commercial products and sell it to UT.

    轉向協作服務。第四季度的收入為 950 萬美元,而 2021 年為 120 萬美元。2022 年第四季度合作收入的主要驅動力與 United Therapeutics 的 Tyvaso DPI 的製造有關,而 2021 年的收入受到 Tyvaso DPI 攤銷結束的影響研發里程碑和延遲 FDA 對該藥物的批准,這意味著我們必須推遲收入,直到我們能夠製造商業產品並將其出售給 UT。

  • The full year revenue of $27.9 million largely reflects manufacturing revenue recognition that began in the second quarter and is lower in 2022 versus '21 because of the prior year UT milestone amortization and the first half 2022 deferral of revenue associated with the delay in the start of commercial manufacturing.

    2790 萬美元的全年收入主要反映了從第二季度開始的製造收入確認,2022 年低於 21 年,因為上一年 UT 里程碑攤銷和 2022 年上半年與延遲開始相關的收入遞延商業製造。

  • In addition to UT-related revenue recognized in 2022, we had $37.9 million of deferred revenue on the year-end balance sheet associated with UT activities, which will be recognized to income through 2031, which is the remainder of the commercial supply agreement with UT. I will review this in further detail in a few minutes.

    除了 2022 年確認的與 UT 相關的收入外,我們在年末資產負債表上還有 3790 萬美元與 UT 活動相關的遞延收入,這些收入將在 2031 年之前確認為收入,這是與 UT 的商業供應協議的剩餘部分.我將在幾分鐘後對此進行更詳細的審查。

  • Lastly, we recorded royalties on net sales of Tyvaso DPI by United Therapeutics to their customers. The (inaudible) in royalties recognized for the quarter was almost 50% higher than the third quarter and demonstrates strong demand for the product. We have recognized $15.6 million in revenues since the product was launched by UT in June.

    最後,我們記錄了 United Therapeutics 對其客戶的 Tyvaso DPI 淨銷售額的特許權使用費。本季度確認的(聽不清)特許權使用費比第三季度高出近 50%,表明對該產品的需求強勁。自 UT 在 6 月份推出該產品以來,我們已經確認了 1560 萬美元的收入。

  • The next slide shows 2022 growth on a quarter-to-quarter basis. This graphic really shows the change in our company this past year, growing total 200% from first quarter to fourth quarter. The second quarter of 2022 marked a change to multiple sources of commercial revenue when we began to benefit from commercial production of Tyvaso DPI, the launch Tyvaso DPI by UT for which we are in low double-digit royalties and the purchase of V-Go. As we exited 2022 and lean forward to 2023, our fourth quarter run rate of $36 million puts us almost halfway to $200 million in total revenues.

    下一張幻燈片顯示了 2022 年的季度環比增長。這張圖真實地顯示了我們公司過去一年的變化,從第一季度到第四季度總共增長了 200%。 2022 年第二季度標誌著多種商業收入來源發生了變化,我們開始受益於 Tyvaso DPI 的商業生產、UT 推出的 Tyvaso DPI,我們為此支付了兩位數的低版稅以及購買了 V-Go。當我們結束 2022 年並向前邁進 2023 年時,我們第四季度 3600 萬美元的運行率使我們的總收入幾乎達到 2 億美元的一半。

  • Now let's look at the profitability of our endocrine products, Afrezza and V-Go. Afrezza gross margin increased from 62% in the fourth quarter of '21 to 92% in the fourth quarter of 2022 and the gross profit associated with Afrezza increased to $11.1 million in the quarter. The increase in the fourth quarter gross margin versus 2021 was due to a decrease in cost of goods sold, mainly from lower inventory write-offs, lower cost per unit, lower excess manufacturing capacity costs and a high level of manufacturing activity in the fourth quarter of 2022, which capitalized a higher amount of cost of inventory, plus an increase in Afrezza net revenue.

    現在讓我們看看我們的內分泌產品 Afrezza 和 V-Go 的盈利能力。 Afrezza 的毛利率從 21 年第四季度的 62% 增加到 2022 年第四季度的 92%,本季度與 Afrezza 相關的毛利潤增加到 1110 萬美元。第四季度毛利率較 2021 年有所增加是由於銷售成本下降,這主要是由於第四季度庫存核銷減少、單位成本降低、過剩製造能力成本降低以及製造活動水平高2022 年,將更高的庫存成本資本化,加上 Afrezza 淨收入的增加。

  • When looking at the profitability for the full year of 2022, Afrezza had a gross margin of 80% and gross profit of $34.6 million, which were both markedly improved in 2021. The main drivers of the improvement were lower cost of goods sold, mainly from a decrease in excess manufacturing capacity costs which is a benefit from Tyvaso DPI production absorption, lower cost per unit, a $2 million fee incurred for an amendment of our insulin supply agreement in the second quarter of 2021 and lower inventory write-offs plus increased net revenue.

    從 2022 年全年的盈利情況來看,Afrezza 的毛利率為 80%,毛利潤為 3460 萬美元,這兩項在 2021 年都有顯著改善。改善的主要驅動因素是銷售成本降低,主要來自產能過剩成本的降低得益於 Tyvaso DPI 生產吸收、單位成本降低、2021 年第二季度胰島素供應協議修訂產生的 200 萬美元費用以及庫存註銷減少以及淨額增加收入。

  • Please note that there will always be some variability in Afrezza gross margin between quarters due to the timing of manufacturing spend and activities as we are not yet at maximum production capacity.

    請注意,由於我們尚未達到最大生產能力,由於製造支出和活動的時間安排,Afrezza 毛利率在兩個季度之間總會有一些變化。

  • The far right table shows V-Go year-to-date gross margin of 43%, which has remained consistent quarter-to-quarter since we acquired the product. 2022 was the year focused on the commercial manufacture of Tyvaso DPI at our facility in Denver and Connecticut, but we were also focused on increasing the efficiency of our current manufacturing lines as well as building out increased manufacturing capacity. These activities led to both Tyvaso DPI revenue being recognized as well as being deferred in 2022.

    最右邊的表格顯示 V-Go 年初至今的毛利率為 43%,自我們收購該產品以來,該季度與上一季度的毛利率保持一致。 2022 年是我們在丹佛和康涅狄格州的工廠專注於 Tyvaso DPI 商業化生產的一年,但我們也專注於提高當前生產線的效率以及擴大製造能力。這些活動導致 Tyvaso DPI 收入在 2022 年得到確認和遞延。

  • The left-hand side of the table shows our revenue recognized for the year. Revenues mainly associated with the manufacturing of Tyvaso DPI and activities for the next-gen R&D services totaled $27 million while royalties accumulated $16 million in revenue for a total of $43 million in Tyvaso DPI-related revenues for 2022.

    表格的左側顯示了我們當年確認的收入。主要與 Tyvaso DPI 製造和下一代研發服務活動相關的收入總計 2700 萬美元,而特許權使用費累計收入 1600 萬美元,2022 年 Tyvaso DPI 相關收入總計 4300 萬美元。

  • Moving to the right side of the table. We started the year with a deferred revenue balance of $19 million and added another $19 million in revenue deferrals, mainly associated with the Tyvaso DPI facility expansion, manufacturing process improvements and pre-commercial activities. We expect additional revenue deferrals in 2023 while conducting activities paid for by UT related to the facility expansion and further manufacturing process improvements. Please note that UT is paying MannKind promptly for all activities where the revenue was recognized or deferred, so cash flow is not adversely impacted by any of these activities.

    移動到表的右側。今年年初,我們的遞延收入餘額為 1900 萬美元,又增加了 1900 萬美元的遞延收入,主要與 Tyvaso DPI 設施擴建、製造工藝改進和商業前活動有關。我們預計 2023 年會有額外的收入遞延,同時開展由 UT 支付的與設施擴建和進一步改進製造流程相關的活動。請注意,UT 正在為確認或遞延收入的所有活動及時向 MannKind 付款,因此現金流不會受到任何這些活動的不利影響。

  • Let me conclude with some final comments around the liquidity. We ended the fourth quarter with $173 million in cash, cash equivalents and investments, a decrease of $5 million from September 30. We achieved this low level of cash burn because of the fourth quarter collection of monies owed to us from UT and Zealand that were outstanding at September 30.

    讓我以關於流動性的一些最後評論作為結束。我們在第四季度結束時擁有 1.73 億美元的現金、現金等價物和投資,比 9 月 30 日減少了 500 萬美元。我們實現了這種低水平的現金消耗,因為第四季度從 UT 和 Zealand 收回了欠我們的款項9 月 30 日未清償。

  • Looking ahead to 2023, we expect to reduce our cash burn as we benefit from the impact of increased cash flows from our collaboration with UT and reduced cash burn associated with our endocrine commercial business unit as we move that unit towards profitability. But also note that we'll be increasing [the depth] behind the development of our product pipeline which is quickly becoming our next lever of shareholder value.

    展望 2023 年,我們預計將減少我們的現金消耗,因為我們受益於我們與 UT 合作帶來的現金流增加的影響,以及隨著我們將該部門轉向盈利而減少與我們的內分泌商業業務部門相關的現金消耗。但也請注意,我們將增加我們產品線開發背後的[深度],這正迅速成為我們股東價值的下一個槓桿。

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

    謝謝,我會把它轉回給邁克。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Thank you, Steve. So as we look at MannKind's products and pipeline, you continue to see this get bolstered up year after year. Afrezza is now on track to hopefully get forward with IND filing this year, pediatric wrap-up and V-Go's launch. On the pipeline, what people don't appreciate is how much time it takes in the early stages of the pre-IND formulation and getting the dosing right and the tox data right in order to progress these into Phase I, II and III. Rest assured 201, 301 and 501 had a lot of work behind them that we will start to see the fruits of that labor over the coming couple of years. Right now, 101 has been full speed ahead, 201 is right behind it and hope to share continued updates with you on 301 and 501 as we go forward.

    謝謝你,史蒂夫。因此,當我們查看 MannKind 的產品和管道時,您會繼續看到這一點年復一年地得到加強。 Afrezza 現在有望在今年提交 IND 申請、兒科總結和 V-Go 的推出方面取得進展。在管道中,人們不了解的是,在 IND 前配方的早期階段以及獲得正確的劑量和正確的毒性數據以將其推進到 I、II 和 III 階段需要多少時間。請放心,201、301 和 501 背後有大量工作要做,我們將在未來幾年開始看到這些工作的成果。現在,101 已經全速前進,201 緊隨其後,希望在我們前進的過程中與您分享 301 和 501 的持續更新。

  • This pipeline momentum over the next 24 months, whether it's the endocrine business or the orphan lung, you can see we have 2 major pillars of continued momentum that will drive shareholder value over the coming quarters. I won't go through each one of these, but you can really start to see how 101 and 201 in the pipeline really starts to march ahead and MannKind builds out the scientific agenda.

    未來 24 個月的管道勢頭,無論是內分泌業務還是孤兒肺,你都可以看到我們有兩個主要的持續動力支柱,將在未來幾個季度推動股東價值。我不會詳細介紹其中的每一個,但您可以真正開始看到正在籌備中的 101 和 201 是如何真正開始向前邁進的,以及 MannKind 是如何制定科學議程的。

  • I won't spend a lot of time on V-Go, but a lot of people ask me when you bought it, what else are you planning to do? We continue to drive innovation and ideas around how do we create other opportunities for this device to biosimilars, buy and build, or just clinical improvement with slow infusion. As one of our thought leaders behind V-Go has said, if you go to the lawn and put a big bowl of [water] in one spot, you get mud. When you spread that out over a lawn, you get green grass. I think that's one of the reasons you continue to see V-Go improve people's A1C and you're spreading that bolus in that base over a long period of time and continue to spread that over a larger space. I think that's important, and we think there's other ideas that we can generate as we continue to allocate time, energy and money to this product.

    我不會在 V-Go 上花很多時間,但是很多人問我,你買了它,你還打算做什麼?我們繼續推動創新和想法,圍繞我們如何為該設備創造生物仿製藥、購買和製造的其他機會,或者只是通過緩慢輸注進行臨床改進。正如我們支持 V-Go 的思想領袖之一所說,如果你去草坪並在一個地方放一大碗 [水],你會得到泥漿。當你把它鋪在草坪上時,你會得到綠草。我認為這是你繼續看到 V-Go 改善人們的 A1C 的原因之一,並且你在很長一段時間內在那個基礎上傳播這種藥丸,並繼續將其傳播到更大的空間。我認為這很重要,而且我們認為,隨著我們繼續為該產品分配時間、精力和金錢,我們可以產生其他想法。

  • A lot of people ask me, have I missed the run up with a company where is MannKind going. I think as we step away and look out, we see 3 key value drivers: Afrezza growth and V-Go growth, number one; number two, Tyvaso continues to grow in new patients, conversion and improved coverage through Medicare as that donut hole closes in '24 and '25. Additionally, there's a large upside to the TETON study readout positive by United Therapeutics. And then you have the pipeline progress which is 101 and 201 and any other additional BD opportunities that come our way, we anticipate any other partnerships that we could put on the platform.

    很多人問我,我是否錯過了 MannKind 要去的一家公司的準備工作。我認為當我們放眼望去時,我們看到了 3 個關鍵的價值驅動因素:Afrezza 增長和 V-Go 增長,排名第一;第二,隨著 24 和 25 年甜甜圈洞的關閉, Tyvaso 繼續在新患者中增長,通過醫療保險轉化和改善覆蓋面。此外,United Therapeutics 對 TETON 研究的積極讀數有很大的好處。然後你有 101 和 201 的管道進展以及我們遇到的任何其他 BD 機會,我們預計我們可以在平台上建立任何其他合作夥伴關係。

  • So that's our fourth pillar growth. But at the end of the day, we really look and see there's lots of upside from where we go. When you look out over the last 5 years of history, every year, we've continued to end on a higher note than when we started. And I think that's critical to our future success and believing in our shareholders and what we're doing to continue to allocate capital and do a great job for everyone who is a key stakeholder of MannKind.

    所以這是我們的第四個支柱增長。但在一天結束的時候,我們真的看到我們去的地方有很多好處。當你回顧過去 5 年的歷史時,每一年,我們都繼續以比開始時更高的音調結束。我認為這對我們未來的成功和相信我們的股東以及我們正在做的事情至關重要,以繼續分配資本並為 MannKind 的每個主要利益相關者做好工作。

  • And I want to say thank you again for all the work everyone is doing, Steve, for your partnership, but it really feels great to be through that transition of capital balance sheet challenges, product innovation, business development. We are now a self-sustaining, fully integrated, midsized pharmaceutical company, and it feels really good to kind of close out '22 and kick off '23 being in that position. So thank you, and we'll open up for questions, Lisa.

    我想再次感謝你所做的所有工作,史蒂夫,感謝你的合作夥伴關係,但經歷資本資產負債表挑戰、產品創新和業務發展的轉變真的感覺很棒。我們現在是一家自給自足、完全整合的中型製藥公司,在 22 年結束並開始 23 年處於那個位置感覺真的很好。所以謝謝你,我們會開放的問題,麗莎。

  • Operator

    Operator

  • (Operator Instructions) First question I have is coming from Brandon Folkes of Cantor.

    (操作員說明)我的第一個問題來自 Cantor 的 Brandon Folkes。

  • Brandon Richard Folkes - Analyst

    Brandon Richard Folkes - Analyst

  • Congratulations on all the progress this year and the last 7 years. Maybe just 2 for me. Just any update on the Tyvaso manufacturing inventory scale up? Just given comments from UT about sort of how they view that product longer term, how should we think about manufacturing scale up there? And then secondly, on the ABC trial, can you just talk us through how we should think about the revenue pull-through from the readout obviously recently and then later this year? And then -- I had 3. Any very early feedback you got from the last 2 days since that press release?

    祝賀今年和過去 7 年取得的所有進步。也許對我來說只有 2 個。關於 Tyvaso 製造庫存擴大的任何更新?剛剛給出了 UT 關於他們如何長期看待該產品的評論,我們應該如何考慮那裡的製造規模?其次,在 ABC 試驗中,您能否談談我們應該如何考慮最近和今年晚些時候明顯從讀數中獲得的收入?然後 - 我有 3 個。自該新聞稿發布後的最後兩天,您是否收到了任何非常早期的反饋?

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Brandon, last question, any feedback?

    布蘭登,最後一個問題,有什麼反饋嗎?

  • Brandon Richard Folkes - Analyst

    Brandon Richard Folkes - Analyst

  • Since you put out the press release on the...

    自從你在...上發布了新聞稿

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Okay, sure. So I'll take each one of those. I think on the manufacturing inventory listed by United Therapeutics yesterday, I think one of the things I heard was the order patterns had some impact, but also the pharmacy days on hand inventory. And the demand has been very strong on Tyvaso, which is great, but it also puts a lot of stress and strain on our manufacturing. We've been able to stay well ahead of the demand, but that has not allowed people to build as much inventory as they want as we continue to -- production goes right in, we can modify it each week on which cartage strength do we fill, which pack-size do we send to the packager. But we haven't reached full capacity manufacturing yet as we continue to look over the last 6 months.

    好的,當然。所以我會接受每一個。我認為關於 United Therapeutics 昨天列出的製造庫存,我認為我聽到的其中一件事是訂單模式有一些影響,還有藥房庫存天數。對 Tyvaso 的需求非常強勁,這很好,但它也給我們的製造帶來了很大的壓力和壓力。我們已經能夠遠遠領先於需求,但這並不能讓人們像我們繼續那樣建立他們想要的庫存——生產馬上開始,我們可以每周修改它,我們的運輸強度是多少填充,我們發送給包裝商的包裝尺寸。但我們還沒有達到滿負荷生產,因為我們繼續觀察過去 6 個月。

  • There are definitely lots of things to work through in the equipment and scale up that have been worked through, and we consistently expect Q1 to show a much more consistent, I'll say, productivity impact in Q1 versus Q3 and Q4. We don't anticipate any inventory issues. We continue to stay well ahead of demand. And I think you'll continue to see that productivity out of our plant and the efficiencies this year, so we're doing things to add additional production capacity just in case demand continues to go faster than we would anticipate.

    在設備和已經完成的擴大規模方面肯定有很多事情需要解決,我們一直希望第一季度能夠顯示出更加一致的,我會說,與第三季度和第四季度相比,第一季度的生產力影響。我們預計不會出現任何庫存問題。我們繼續遠遠領先於需求。而且我認為你會繼續看到我們工廠今年的生產力和效率,所以我們正在做一些事情來增加額外的生產能力,以防需求繼續比我們預期的更快。

  • Remember, when we built the factory that we made Tyvaso DPI, we made it for PAH and ILD at a time when the new team was doing $400 million, $450 million revenue with ILD expected. Obviously, that product is now well and away from $1 billion plus this year. And we want to make sure we continue to stay well ahead of that ability to convert as much of that as UT can do. So we don't anticipate any issues and in the factory build-out itself.

    請記住,當我們建造製造 Tyvaso DPI 的工廠時,我們是為 PAH 和 ILD 製造的,當時新團隊正在做 4 億美元,預期 ILD 的收入為 4.5 億美元。顯然,該產品現在很好,今年還不到 10 億美元。我們希望確保我們繼續保持領先的能力,盡可能多地轉換 UT 可以做到的。因此,我們預計在工廠擴建過程中不會出現任何問題。

  • Again, we expect that to be completed later this year. Part of it will require an FDA inspection and that -- we'll just deal with that when that time comes. But we don't need that factory expansion to complete in order to keep ahead of supply. So we're pretty good with that there. The factory expansion is really to handle IPS demand that could come in '24 and beyond. And so we're well ahead of that readout for that clinical trial.

    同樣,我們預計這將在今年晚些時候完成。其中一部分將需要 FDA 檢查,而那——我們會在那個時候處理它。但我們不需要完成工廠擴建來保持領先供應。所以我們在那裡做得很好。工廠擴建實際上是為了處理 24 世紀及以後可能出現的 IPS 需求。因此,我們遠遠領先於該臨床試驗的讀數。

  • On the ABC trial, in terms of revenue pull through, the way to think about this is a pilot study that I've been wanting to do for many years, showing that you don't need insulin pumps, that they're not adding as much control as people think. And every doctor you talk to believes pump therapy is the best you could do and that there's nothing better, even though there's very little head-to-head data showing pumps are better than multiple daily injections.

    在 ABC 試驗中,就收入拉動而言,思考這個問題的方式是我多年來一直想做的一項試點研究,表明你不需要胰島素泵,他們不會添加人們認為的控制力。與您交談的每一位醫生都認為泵療法是您能做的最好的,沒有比這更好的了,儘管很少有頭對頭數據顯示泵比每日多次注射更好。

  • In fact, I believe there's a data set, I don't know if it's public yet, but it should be this week at ATTD, that all the benefit of (inaudible) is happening in the first day. And so really, you get the bolus of improvement and then it kind of stops. And we think that the diabetes burden of wearing a pump, wearing a CGM is really starting to wear out people as they live with this disease and pumps for 20, 30, 40 years. They're running out of real estate on their skin. They're having scarring. There's a lot of issues. And we do believe there's an opportunity that's going to be created over the next 1 or 2 years. When the TETON piece reads out, that's our pivotal Phase III, the next question we're going to get is what about insulin pumps.

    事實上,我相信有一個數據集,我不知道它是否公開,但應該是本週在 ATTD 上,(聽不清)的所有好處都在第一天發生。所以真的,你得到了改善,然後它就停止了。我們認為,佩戴泵、佩戴 CGM 的糖尿病負擔真的開始讓人們疲憊不堪,因為他們患有這種疾病和泵 20、30、40 年。他們的皮膚上的房地產用完了。他們有疤痕。有很多問題。我們確實相信在未來 1 或 2 年內將會創造機會。當 TETON 文章讀出時,這是我們關鍵的第三階段,下一個問題是胰島素泵。

  • So we're trying to get ahead of that question by running this larger PUP switch trial, which will switch patients off of MDI and pumps and run head-to-head at the end of the day. So we'll have more design on that Phase IV. Now there's an advisory meeting this week at ATTD, and I'll give that feedback next week. But I would say the feedback so far, the data has not been presented until Saturday. But the feedback at the conference and the word about MannKind has actually been really nice, and we're hearing really good things, people were asking about. So that's the only feedback I have so far. The data set itself has not been presented yet.

    因此,我們試圖通過運行這個更大的 PUP 轉換試驗來解決這個問題,該試驗將使患者停止使用 MDI 和泵,並在一天結束時進行正面交鋒。因此,我們將在第四階段進行更多設計。現在 ATTD 本週召開了一次諮詢會議,我將在下週提供反饋。但我會說到目前為止的反饋,數據直到週六才呈現。但會議上的反饋和關於 MannKind 的說法實際上非常好,我們聽到了非常好的事情,人們在問。所以這是我迄今為止唯一的反饋。數據集本身尚未呈現。

  • Operator

    Operator

  • Our next question will be coming from Steven Lichtman of Oppenheimer.

    我們的下一個問題將來自 Oppenheimer 的 Steven Lichtman。

  • Unidentified Analyst

    Unidentified Analyst

  • This is Ron on for Steve. I was hoping you guys can -- I saw you -- you're going to launch BluHale next month. Last time, you talked a little bit about the chip shortage, and I wonder if you could give us an update on how that was resolved and how you're looking forward -- how are you looking at that looking forward, and how are you preparing for the launch, considering that. And also, if I can have a short follow up, that would be great.

    這是羅恩為史蒂夫準備的。我希望你們能——我看到你們了——你們將在下個月推出 BluHale。上次,你談到了芯片短缺問題,我想知道你是否可以向我們介紹一下這個問題是如何解決的以及你對未來的展望——你是如何看待這個問題的,你是如何看待的?考慮到這一點,準備發射。而且,如果我能進行簡短的跟進,那就太好了。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Sure. On BluHale, the chip shortage, I don't believe is an issue. I think there's other parts that became obsolete that we're updating and reworking in the device a little bit. So all that's working through. But I think we have devices right now to kick off the pilot, and that pilot is really going to drive the human factors. And the insight feedback will drive the launch investment and/or plan in the second half. I think what's really nice is this the first time where we're going to have dosing and Dexcom CGM integrated as we talked about going into type 1, we do think providing those insights to a patient and to a provider are really important, and that's something has pipe from Type 2 to Type 1 on Afrezza that this is going to be a critical device in the second half, assuming we get positive patient feedback. So that's -- we don't anticipate any type of shortage in the next 1,000 devices to launch. We think that will be fine at this point, from what we can see.

    當然。對於 BluHale,我認為芯片短缺不是問題。我認為還有其他部分已經過時,我們正在對設備進行一些更新和改造。所以這一切都在努力。但我認為我們現在有啟動試點的設備,該試點確實會推動人為因素。洞察反饋將推動下半年的啟動投資和/或計劃。我認為真正好的是這是我們第一次將劑量和 Dexcom CGM 整合在一起,因為我們談到進入 1 型,我們確實認為向患者和提供者提供這些見解非常重要,這就是Afrezza 上有從 2 型到 1 型的管道,假設我們得到積極的患者反饋,這將成為下半年的關鍵設備。這就是 - 我們預計接下來推出的 1,000 台設備不會出現任何類型的短缺。從我們所看到的情況來看,我們認為在這一點上會很好。

  • Unidentified Analyst

    Unidentified Analyst

  • Okay. And then you said you're -- this is going to be integrated with the Dexcom. Are there any plans to integrate with any other glucose monitors? Or are you going to stick with Dexcom on the whole?

    好的。然後你說你是——這將與 Dexcom 集成。是否有與任何其他血糖監測儀集成的計劃?或者你會在整體上堅持使用 Dexcom 嗎?

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • No. I think Dexcom is the easiest because they have open APIs, and we are able to work with them and get that agreement done. I think Libre is obviously the next big one, especially Libre 3. And also I think Senseonics, now that they're getting to the 1-year sensor and starting to launch that, that will be a nice opportunity to look at Senseonics as well. So we want to be platform agnostic at the end of the day from CGM, but we do believe CGM is something that's really important.

    不。我認為 Dexcom 是最簡單的,因為他們有開放的 API,我們能夠與他們合作並完成該協議。我認為 Libre 顯然是下一個大的,尤其是 Libre 3。而且我認為 Senseonics,現在他們已經到了 1 年傳感器並開始推出它,這將是一個很好的機會來了解 Senseonics .所以我們希望在 CGM 的一天結束時成為平台不可知論者,但我們確實相信 CGM 是非常重要的東西。

  • Operator

    Operator

  • Next question is coming from Anthony Petrone of Mizuho.

    下一個問題來自瑞穗的 Anthony Petrone。

  • Anthony Charles Petrone - MD of Senior Medical Devices, Diagnostics & Therapeutics Equity Research Analyst

    Anthony Charles Petrone - MD of Senior Medical Devices, Diagnostics & Therapeutics Equity Research Analyst

  • Congratulations to the team on the execution. Maybe one on BluHale, just when you think of sensor opportunity, you certainly have some synergies with Afrezza. Just want to confirm, is that going to be also used with Tyvaso? And when you think of the ability to monitor inhalation and usage, how do you think that plays out over time? If you're capturing that data, do you get better drug adherence? And ultimately, does that drive better consumption down the road? And then I'll have a few follow ups.

    祝賀團隊執行。也許在 BluHale 上,當您想到傳感器機會時,您肯定會與 Afrezza 產生一些協同效應。只是想確認一下,它是否也將與 Tyvaso 一起使用?當您想到監測吸入和使用情況的能力時,您認為隨著時間的推移會產生怎樣的影響?如果您正在捕獲這些數據,您是否會獲得更好的藥物依從性?最終,這會推動更好的消費嗎?然後我會進行一些跟進。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Sure. I think BluHale has been a long time coming and has had lots of headaches as you're driving innovation because these things take time. But I do think your one question/comment is critical, which is -- especially on Tyvaso and Afrezza, when you're using something for the first time as we continue to improve the number of new doctors prescribing, new educators utilizing and training, people sometimes, especially on like the lower dose cartridge, you don't feel any powder going into the lung. And you're like, did I get my dose?

    當然。我認為 BluHale 已經存在很長時間了,並且在推動創新時遇到了很多麻煩,因為這些事情需要時間。但我確實認為你的一個問題/評論很關鍵,尤其是在 Tyvaso 和 Afrezza 上,當你第一次使用某種東西時,我們會繼續提高新醫生開處方、新教育工作者使用和培訓的數量,人們有時,尤其是使用低劑量藥筒時,您感覺不到任何粉末進入肺部。你就像,我得到我的劑量了嗎?

  • And so showing proper inhalation technique and registering that dose that was taken, I think, improves people's confidence. And that's one of the things we saw early on in our user trial with health care providers, was it improves their confidence in training and ultimately their success with the patient dramatically.

    因此,我認為展示正確的吸入技術並記錄所服用的劑量可以提高人們的信心。這是我們在早期與醫療保健提供者進行的用戶試驗中看到的事情之一,它提高了他們對培訓的信心,並最終顯著提高了他們在患者身上的成功。

  • And so I do think that's not just for the patient, it's also for the provider, for them to start to see that data, the compliance of that, looking at that overlaying with CGM in the case of diabetes, we think will be important. And long term, I just think -- I look at what One Drop has done with data, collecting data sets and predicting outcomes over time. I think this is where we want to go. We think data in health care is going to be critical and starting to collect this data and build out the skill set capability.

    因此,我確實認為這不僅適用於患者,也適用於提供者,讓他們開始查看數據、數據的依從性,在糖尿病的情況下查看與 CGM 的疊加,我們認為這很重要。從長遠來看,我只是想 - 我看看 One Drop 對數據做了什麼,收集數據集並預測隨著時間的推移結果。我認為這是我們想要去的地方。我們認為醫療保健中的數據將變得至關重要,並開始收集這些數據並建立技能組合能力。

  • We're in version 1.0. We have a long ways to go, but this is the beginning of this year to really start to think about -- no better modeling in sugars and data collecting on sugars and predicting what's going to happen with the dose you took. And so we think there's a lot there that will continue to evolve as we start thinking about data scientists and other types of people that we don't have here yet.

    我們的版本是 1.0。我們還有很長的路要走,但今年年初才真正開始思考——沒有更好的糖建模和糖數據收集以及預測你服用的劑量會發生什麼。所以我們認為,隨著我們開始考慮數據科學家和我們這裡還沒有的其他類型的人,那裡會有很多東西會繼續發展。

  • On the UT side, I don't want to comment for them other than they are using the pro version, which is the health care provider edition to show proper inhalation technique, and that is launched. And I believe they will also continue to want biz for their -- what they're doing in their PH. So I don't want to speak to that, but I'll let them communicate that.

    在 UT 方面,除了他們使用的是專業版之外,我不想為他們發表評論,專業版是醫療保健提供者的版本,用於展示正確的吸入技術,並且已發布。而且我相信他們也將繼續希望他們的業務——他們在他們的 PH 中所做的事情。所以我不想談這個,但我會讓他們交流。

  • Anthony Charles Petrone - MD of Senior Medical Devices, Diagnostics & Therapeutics Equity Research Analyst

    Anthony Charles Petrone - MD of Senior Medical Devices, Diagnostics & Therapeutics Equity Research Analyst

  • That's helpful. And then follow ups would be on endocrine studies, you think of pediatric, but also the India trial at JPMorgan, you put some math around this. So for every 10% market share impedes, it's $150 million revenue opportunity or TAM opportunity, let's call it. When you think about that in type 2s, obviously, much larger patient pool. So is there an equivalent number of 10% in type 2s which could be facilitated by India? How should we think about that number? And is the right way to look at it is share gains from GLPs? And I have one last one.

    這很有幫助。然後是內分泌研究的後續行動,你會想到兒科,還有摩根大通在印度的試驗,你會對此進行一些數學計算。因此,對於每 10% 的市場份額阻礙,它就是 1.5 億美元的收入機會或 TAM 機會,我們稱之為。當您在 2 型中考慮這一點時,顯然,患者群體要大得多。那麼,印度是否可以促進 2 類中 10% 的同等數量?我們應該如何看待這個數字?正確的看待它的方式是從 GLP 中獲得的份額收益嗎?我還有最後一張。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Sure. So on the [pedia], I would say that's roughly a good estimate number, but every 10% share rapid acting in kids alone in the U.S. will be about $150 million net revenue to MannKind. So that's why when people say, why don't you invest in a trial now, because we want to set [kids] up for success. This year, the transformation for Afrezza in terms of tightening things up really puts some profitability and moving the branding to strong positioning between the 2 assets. But next year, when all the stuff starts to read out, when we start to prepare for launch, we think these are the right questions and the right answers to have data around to ensure we could achieve 10%, 20%, 30% market share in kids.

    當然。所以在 [pedia] 上,我會說這大致是一個很好的估計數字,但在美國,僅兒童中每 10% 的快速行動份額將為 MannKind 帶來約 1.5 億美元的淨收入。所以這就是為什麼當人們說,你為什麼不現在投資試驗,因為我們想讓[孩子們]為成功做好準備。今年,Afrezza 在收緊方面的轉型確實帶來了一些盈利能力,並將品牌推廣到兩項資產之間的強勢定位。但是明年,當所有的東西都開始宣讀出來,當我們開始準備發佈時,我們認為這些是正確的問題和正確的答案,有數據可以確保我們能夠實現 10%、20%、30% 的市場份額分享給孩子們。

  • There's going to be a huge spillover effect as you're successful in kids into adults. And so that number is just for kids. You can also think about these kids turning 18, 20, 25, they're going to start to go over the old market, and that's going to have a compound effect back into the second half of this decade. So we have a long-term view on this asset. We've taken a long time to get to where we are, but we do believe we're finally at that point, we're assuming all the data reads out as we expect. I think it's going to be very, very exciting on inhaled insulin going forward.

    當你成功地將孩子變成成人時,將會產生巨大的溢出效應。所以這個數字只適合孩子們。你也可以想想這些年滿 18 歲、20 歲、25 歲的孩子,他們將開始超越舊市場,這將在本世紀後半葉產生復合效應。所以我們對這個資產有一個長期的看法。我們花了很長時間才到達現在的位置,但我們確實相信我們終於到了那個點,我們假設所有數據都按我們預期的方式讀出。我認為吸入式胰島素的發展將會非常非常令人興奮。

  • On India, the way I think about India is it's going to be a very low-margin business, but there's [81 million] people living with diabetes (inaudible). But the real benefit for us is (inaudible) on FDKP, which we've already (inaudible) utilizing our factory capacity that's not [available] right now for the U.S., (inaudible) version of in that we've already purchased.

    在印度,我對印度的看法是它將成為一個利潤率非常低的行業,但有 [8100 萬] 糖尿病患者(聽不清)。但對我們來說真正的好處是(聽不清)FDKP,我們已經(聽不清)利用了我們的工廠產能,現在我們已經購買了美國(聽不清)版本。

  • So these are things that ultimately, when you look at year-over-year, a (inaudible) profitable because of the fact that it becomes more efficient with Tyvaso, (inaudible) happening benefiting United as much as MannKind as we launch India production in the factory in 2024. So that's how I think about India's efficiency play, utilizing some cost and getting some of that -- recouping some of those investments we've already made.

    因此,當您逐年查看時,這些事情最終會(聽不清)盈利,因為 Tyvaso 變得更有效率,(聽不清)隨著我們在印度推出印度生產而使 United 和 MannKind 受益2024 年的工廠。這就是我對印度效率遊戲的看法,利用一些成本並獲得其中的一些——收回我們已經進行的一些投資。

  • And then on the type 2 market, I think 1 thing that will play out over the next year is here in the U.S. is the GLPs have had tremendous success. The weight loss category is growing. And that's really pushing insulin -- either declining the market or pushing it later. And I think what people are going to see is that despite all the great success of GLPs, patients are still going to need mealtime control. They're still going to need to get some extra help there.

    然後在 2 型市場上,我認為明年將在美國發生的一件事是 GLP 取得了巨大的成功。減肥類別正在增長。這確實在推動胰島素——要么是市場下滑,要么是推後市場。而且我認為人們將會看到的是,儘管 GLP 取得了巨大的成功,但患者仍然需要控制進餐時間。他們仍然需要在那裡獲得一些額外的幫助。

  • And I do believe that inhaled insulin is going to play a role in that, will help us decide as we look at our progress for the year, do we want to do a study using Afrezza on top of GLP where we have no data, is that something the either investigator does or something we want to do? That's kind of the next way we think about diabetes.

    我確實相信吸入胰島素將在其中發揮作用,將幫助我們在審視我們今年的進展時做出決定,我們是否想在沒有數據的情況下在 GLP 之上使用 Afrezza 進行研究,是是調查員做的事還是我們想做的事?這就是我們思考糖尿病的下一種方式。

  • The other thing is as we get (inaudible) in type 1 and [become the] brand of choice, we know those doctors will automatically use Afrezza in type 2 by default. So there's somewhat of a really -- it's not (inaudible) if I was to use type 2, they don't think about type 1. But it's a work in (inaudible) way .

    另一件事是,當我們獲得(聽不清)類型 1 並[成為]首選品牌時,我們知道這些醫生默認情況下會自動使用類型 2 中的 Afrezza。所以有一點真的 - 如果我要使用類型 2,他們不會考慮類型 1,但它不是(聽不清)。但它是一種(聽不清)方式的工作。

  • Anthony Charles Petrone - MD of Senior Medical Devices, Diagnostics & Therapeutics Equity Research Analyst

    Anthony Charles Petrone - MD of Senior Medical Devices, Diagnostics & Therapeutics Equity Research Analyst

  • Just a pretty last quick one. Just Apple made some news this week about potentially hopping in here. You're collaborating with CGM providers. I don't know if you have any 2 cents you can add on some of the news that came out of Apple.

    只是最後一個快速的。本週只有 Apple 發布了一些關於可能跳入這裡的消息。您正在與 CGM 提供商合作。我不知道你是否有任何 2 美分可以添加到 Apple 的一些新聞中。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Yes. Thank you. Look, I think Apple, Amazon guys continue to get involved in health care technology and health care data at the end of the day. And I think where we're going with BluHale, back to your question, having that data, being able to have that data predict where people are going to have to go and start to think about outcome contracts. I mean everyone is looking at ways to drive better outcomes at a lower cost, and use data to help that.

    是的。謝謝。聽著,我認為蘋果和亞馬遜的傢伙最終會繼續涉足醫療保健技術和醫療保健數據。我認為我們將與 BluHale 一起去哪裡,回到你的問題,擁有這些數據,能夠讓這些數據預測人們將不得不去哪裡並開始考慮結果合同。我的意思是每個人都在尋找以更低的成本取得更好成果的方法,並使用數據來幫助實現這一目標。

  • I think it's premature for us to think about where would Apple be in 5 years because I go back to my stint at Novartis, where we were going to have a contact lens that was measuring (inaudible) with Google, if I recall, and that never came out, right? So there's a lot of excitement, but it takes time for this innovation to happen. And health care is not an easy feat to kind of enter into, but we'll keep watching it.

    我認為我們現在考慮蘋果在 5 年後的位置還為時過早,因為我回到了我在諾華公司的工作,如果我記得的話,在那裡我們將有一個與穀歌一起測量(聽不清)的隱形眼鏡,那從來沒有出來,對吧?所以有很多令人興奮的事情,但是要實現這種創新需要時間。醫療保健不是一件容易進入的壯舉,但我們會繼續關注它。

  • Operator

    Operator

  • The next question will be coming from Gregory Renza of RBC.

    下一個問題將來自 RBC 的 Gregory Renza。

  • Gregory James Renza - Analyst

    Gregory James Renza - Analyst

  • Great. Mike and Steve, congrats on the year on the progress. Mike, just maybe a quick one. As you build on the success of Tyvaso DPI of course, what we all know about the potential option to license the platform for a second PAH product with UniTher. And I know that the front levers that you and Steve are describing really lie in the pipeline launches over the next several years. I'm just curious how you think about some of the parameters or potential with a second option or second license with UniTher and how that potentially factors into some of your goals about one indication or product per year over the next several years in your pipeline?

    偉大的。邁克和史蒂夫,祝賀這一年取得的進步。邁克,也許只是一個快速的。當然,當您在 Tyvaso DPI 的成功基礎上再接再厲時,我們都知道可以使用 UniTher 為第二個 PAH 產品許可該平台的潛在選擇。我知道你和史蒂夫所描述的前沿槓桿確實存在於未來幾年的管道發布中。我只是想知道您如何考慮 UniTher 的第二個選項或第二個許可證的一些參數或潛力,以及這些參數如何潛在地影響您在未來幾年中每年關於一個適應症或產品的一些目標?

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Yes, no, great question. And I think over time, we've -- Tyvaso is going to be so large as we talk about ideas with UniTher, that we want to make sure that, that gets off on the right foot because -- whether that's $1 billion, $2 billion plus, I think that's really UT's purview, we want to make sure we can make supply and be ready for it and not distract our collective teams on that one. I do believe that over time, we will find other ways to help our patients, I know Martine is dedicated to that focus. And we'll continue to assess opportunities that come in to us or through them in PAH any other areas that they're focused on.

    是的,不,很好的問題。而且我認為隨著時間的推移,我們已經 - Tyvaso 將變得如此之大,因為我們與 UniTher 談論想法,我們希望確保這一點,這是正確的,因為 - 無論是 10 億美元,還是 2 美元十億多,我認為這真的是 UT 的職權範圍,我們希望確保我們能夠提供供應並為此做好準備,而不是分散我們集體團隊的注意力。我確實相信,隨著時間的推移,我們會找到其他方法來幫助我們的患者,我知道 Martine 致力於這一重點。我們將繼續評估進入我們或通過他們在 PAH 中他們關注的任何其他領域的機會。

  • I would say, in general, MannKind, we've gone through a pretty deep assessment with our Board in the second half of last year around how much energy do we want to continue to put in the platform in terms of going out and seeking partnerships through large pharma, midsize pharma versus continuing to innovate our own assets. And we decided that our real focus is bringing our assets forward as fast as possible, dedicating to double down on new ideas within our platform or other platforms that we see out there and less so on trying to drive more partnerships.

    我想說,總的來說,MannKind,我們在去年下半年與我們的董事會進行了相當深入的評估,圍繞我們希望在走出去和尋求合作夥伴關係方面繼續投入多少精力通過大型製藥公司、中型製藥公司與繼續創新我們自己的資產。我們決定我們真正的重點是盡可能快地推進我們的資產,致力於在我們的平台或我們看到的其他平台內加倍努力,而不是試圖推動更多的合作夥伴關係。

  • Of course, [everyone wants to know the next deal], but I think we've picked a lot of the key opportunities already to develop inhaled therapeutics that we think can make a difference. And now our focus is really on even earlier stage innovation. As we get out there and think about 2030 and beyond, it's probably not a repurposed asset, it's probably an NCE in some more [familiar] conditions. And that's kind of -- people look and say, where are you in '23? These decisions we made 3 years ago, in '24, were made 3 years ago. So we're working on focus for 2030, 2028. We feel like the pipeline is enough to drive a lot of innovation forward in the next couple of years.

    當然,[每個人都想知道下一筆交易],但我認為我們已經選擇了很多關鍵機會來開發我們認為可以發揮作用的吸入療法。現在我們的重點實際上是更早期的創新。當我們走出去思考 2030 年及以後的情況時,它可能不是重新調整用途的資產,它可能是一些更 [熟悉] 條件下的 NCE。這有點——人們看著說,你在 23 年在哪裡?我們在 24 年 3 年前做出的這些決定是 3 年前做出的。因此,我們正在專注於 2030 年、2028 年。我們認為管道足以在未來幾年推動大量創新。

  • But that does not mean every -- like every day, the last couple of weeks, I've had an inbound business development, whether it's, can we work with you, can we work -- do you want to sell something? But there's a lot of activity out there happening. There's a lot of companies out of money or refocusing their strategy and divesting noncore assets. And so we'll keep looking, but we feel pretty good about where we stand and driving that future for value.

    但這並不意味著每一天,就像過去幾週的每一天,我都有一個入境業務發展,無論是,我們可以和你一起工作,我們可以工作 - 你想賣東西嗎?但是那裡正在發生很多活動。有很多公司資金不足或重新調整戰略重點並剝離非核心資產。所以我們會繼續尋找,但我們對自己的立場和推動未來價值的感覺非常好。

  • Operator

    Operator

  • And the next question will be coming from Tom Smith of SVB.

    下一個問題將來自 SVB 的湯姆史密斯。

  • Michael Holden Kratky - Research Analyst

    Michael Holden Kratky - Research Analyst

  • This is Mike on for Tom. Are there any gating factors remaining for the adaptive Phase II/III study of clofazimine expected in the second half of this year? Can you briefly describe kind of the planned study design? And how quickly do you imagine we could start to see data from that study?

    這是湯姆的邁克。預計今年下半年進行的氯法齊明適應性 II/III 期研究是否還有任何門控因素?你能簡要描述一下計劃中的研究設計嗎?您認為我們能以多快的速度開始查看該研究的數據?

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • How quickly, I'm sorry?

    多快,對不起?

  • Michael Holden Kratky - Research Analyst

    Michael Holden Kratky - Research Analyst

  • Could we see data from that study?

    我們可以看到該研究的數據嗎?

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Okay. Yes. I don't want to comment too early on some of the study details yet either for competitive reasons that we're still finalizing that. But what I would say is the gating factors are really twofold: one, open up the IMT; and two, just working with the international regulatory bodies to make sure we can import drug and hope the trial gets activated.

    好的。是的。我不想過早評論一些研究細節,但出於競爭原因,我們仍在最後確定。但我要說的是,門控因素實際上是雙重的:一是開放IMT;二是開放IMT。第二,與國際監管機構合作以確保我們可以進口藥物並希望試驗能夠啟動。

  • Those are the 2 biggest gating factors. We are pretty close with the FDA in terms of some of the last-minute trial details we focused on. And in particular, there's a quality-of-life metric that people want to know about NTM and then there's the assumption on sputum conversion.

    這些是兩個最大的門控因素。就我們關注的一些最後一刻的試驗細節而言,我們與 FDA 非常接近。特別是,人們想了解 NTM 的生活質量指標,然後是關於痰轉化的假設。

  • And so you can expect the trial design will incorporate some of those features. And I can tell you it will not be established patients. We're looking at earlier treatment patients who were on general background therapy. So we're not going after naive. We felt that would be too hard to enroll and too expensive relatively to the time it would take. And so we're looking for earlier stage people not responding on GPT in a global way, so will be U.S., some places in Europe, Japan, South Korea, Australia are the key areas.

    因此,您可以預期試驗設計將包含其中一些功能。我可以告訴你它不會成為確定的患者。我們正在尋找接受一般背景治療的早期治療患者。所以我們不會追求天真。我們覺得註冊起來太難了,而且相對於所需的時間來說太貴了。因此,我們正在尋找在全球範圍內沒有對 GPT 做出回應的早期人員,美國、歐洲的一些地方、日本、韓國、澳大利亞也是關鍵地區。

  • So we're focused on quality of the patient consistency, the patient type and ones that aren't necessarily the ARIKAYCE treatment that are the sickest that may not respond to anything, but really trying to get a little bit earlier in the treatment.

    因此,我們專注於患者一致性的質量、患者類型和那些不一定是 ARIKAYCE 治療的患者,這些患者可能對任何事情都沒有反應,但實際上是在嘗試更早地進行治療。

  • No other gating factors, just getting the IND filed which requires us to get the manufacturing GMP batches up on stability and break that document up to get that submitted, which the teams will feed ahead on and should happen in late Q2, early Q3, hopefully. And once that's filed, that will be the last thing before we investigate this ourselves.

    沒有其他的門控因素,只是提交 IND,這要求我們使製造 GMP 批次穩定並分解該文件以提交該文件,團隊將繼續推進並應該在第二季度末、第三季度初發生,希望如此.一旦提交,這將是我們自己調查之前的最後一件事。

  • Michael Holden Kratky - Research Analyst

    Michael Holden Kratky - Research Analyst

  • Understood. And then just one kind of follow up. From a modeling standpoint, how should we be thinking about the trajectory of SG&A moving forward both throughout 2023 and over the next couple of years just based on the commitment to V-Go relative to the Afrezza sales force restructuring?

    明白了。然後只是一種跟進。從建模的角度來看,我們應該如何考慮 SG&A 在整個 2023 年和未來幾年的發展軌跡,僅僅基於對 V-Go 相對於 Afrezza 銷售隊伍重組的承諾?

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • I'll let Steve take that.

    我會讓史蒂夫接受這個。

  • Steven B. Binder - CFO

    Steven B. Binder - CFO

  • Sure. I think SG&A, we don't talk too much about forward-looking financial information. We don't currently have large gap plans or plans to scale up. However, if we see opportunities, such as the trial readout that come around, we may put money behind our endocrine business. And so what I would say is TBD, but we'll see how it goes.

    當然。我認為 SG&A,我們不會過多談論前瞻性財務信息。我們目前沒有大差距計劃或擴大規模的計劃。然而,如果我們看到機會,比如即將到來的試驗讀數,我們可能會把錢投入到我們的內分泌業務中。所以我要說的是待定,但我們會看到它的進展。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • The thing I would just add to that, Mike, is pediatric spec gets closer, we don't need to add a bunch of expenses. There's about 500 [endos] in the country that make up the majority of the pediatric market. So when you think about the investment for the future indications, it's not a huge infrastructure. We already the people, maybe we add another 5 or 10.

    我要補充的是,邁克,兒科規格越來越接近,我們不需要增加一大筆費用。該國約有 500 [endos],佔兒科市場的大部分。因此,當您考慮對未來適應症的投資時,它並不是一個龐大的基礎設施。我們已經是人了,也許我們再增加 5 或 10 人。

  • But I think if Afrezza keeps going the direction it's going, there's (inaudible) upside, but (inaudible) low market share there that we can hire another 200 reps. We don't do that because we're trying to make it profitable. But if we see a real growth opportunity to expand our growth faster, we can do that. And we've added 3 or 4 new territories this year alone in markets where we've never had a sales rep in. So these are the opportunities we'll look forward, but we're not -- we're looking to keep things relatively stable and (inaudible) drop revenue to the bottom line as we go forward.

    但我認為,如果 Afrezza 繼續沿著它的方向前進,那麼它有(聽不清)上行空間,但(聽不清)市場份額很低,我們可以再僱用 200 名銷售代表。我們不這樣做是因為我們試圖讓它盈利。但如果我們看到一個真正的增長機會來加快我們的增長,我們就可以做到。僅今年一年,我們就在我們從未有過銷售代表的市場中增加了 3 或 4 個新區域。因此,這些是我們期待的機會,但我們不是——我們希望保持隨著我們前進,事情相對穩定並且(聽不清)將收入降至底線。

  • Operator

    Operator

  • Thank you. We'll now turn the call back over to Mike Castagna for closing remarks. Please go ahead, sir.

    謝謝。我們現在將電話轉回 Mike Castagna 以作結束語。請繼續,先生。

  • Michael E. Castagna - CEO & Director

    Michael E. Castagna - CEO & Director

  • Thank you, again, everyone. Thank you for the questions. Thank you, Anthony, for joining us for the first time. It's good to hear some new analysts come in. I think that's important as we think about the next phase of the company. A lot of the questions we're getting is from new investors, is really around the pipeline, the future and what's next. And so we're excited as we anticipated that. [A thousand users] there and attendance right behind it. For us to start off the year strong V-Go, we'll watch over the next 6 weeks as we just launched that in the sales force.

    再次謝謝大家。謝謝你的問題。安東尼,謝謝你第一次加入我們。很高興聽到一些新的分析師加入。我認為這很重要,因為我們考慮公司的下一階段。我們收到的很多問題都來自新投資者,實際上是圍繞管道、未來和下一步。因此,我們很興奮,正如我們所預料的那樣。 [1000 名用戶] 就在那兒,出席人數緊隨其後。為了讓我們開始今年強大的 V-Go,我們將在接下來的 6 週內關注我們剛剛在銷售團隊中推出的情況。

  • But otherwise, super exciting. Looking forward to hopefully wrapping up Q1 in about 6 weeks and sharing that with you in the next quarter here. But otherwise, just thank you, everyone, for everything, and we're always here to answer your questions and hopefully keep creating value with helping patients.

    但除此之外,超級令人興奮。期待在大約 6 週內結束第一季度,並在下一季度與您分享。但除此之外,謝謝大家,感謝你們所做的一切,我們總是在這裡回答你們的問題,並希望通過幫助病人繼續創造價值。

  • Operator

    Operator

  • This concludes today's conference call. Thank you all for joining. Everyone may disconnect, and have a great evening.

    今天的電話會議到此結束。謝謝大家的加入。每個人都可以斷開連接,並度過一個美好的夜晚。