MannKind Corporation (MNKD) 2026 Q2 法說會逐字稿

Good afternoon and welcome to the MannKind Corporation Second Quarter 2026 Financial Results Earnings Call.

下午好，歡迎參加 MannKind Corporation 2026 年第二季財務業績電話法說會。

As a reminder, this call is being recorded on August 5th, 2026 and will be available for replay on the Mankind Corporation website shortly after this call for approximately 90 days.

提醒各位，本通話於 2026 年 8 月 5 日錄音，並將於本通話結束後不久在 MannKind Corporation 官網提供重播，重播期間約 90 天。

This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations.

本通話將包含前瞻性陳述。此等前瞻性陳述受風險與不確定性影響，可能導致實際結果與這些預期存在重大差異。

For further information on the company's risk factors, please see the form 10Q for the period ended June 30, 2026, the earnings release, and the slides prepared for this presentation.

如需進一步了解本公司風險因素，請參閱截至 2026 年 6 月 30 日期間的 10-Q 表格、新聞稿（earnings release）以及本次簡報所準備的投影片。

Joining us today from MannKind , our Chief Executive Officer, Michael Castagna and Chief Financial Officer, Chris Prentice. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

今天與會的 MannKind 代表包括執行長 Michael Castagna 與財務長 Chris Prentice。接下來我想把會議交給 Castagna 先生。先生，請開始。

Thank you, operator, and good afternoon, everyone.

謝謝接線員，大家下午好。

Thank you for joining us for our second quarter 2026 call.

感謝各位參加我們 2026 年第二季電話會議。

I'll start with some opening remarks, walk you through some business updates. Chris will talk about our financial results and I'll close by giving a few closing statements here, followed by Q&A.

我將先做一些開場說明，並帶各位了解一些業務更新。Chris 會說明我們的財務結果，而我將以幾點結語作結，之後進入問答。

Let me start by saying how we transformed our company and our potential growth trajectory with the strategy we outlined back in Q1.

首先我想談談，我們如何透過在第一季所提出的策略，改造公司並重塑我們潛在的成長軌跡。

We laid out three major catalysts this year, Afrezza Pediatrics approval, opening an indication opportunity we have not had access to.

我們今年提出三項主要催化劑：Afrezza 兒科適應症核准，開啟我們過去無法觸及的適應症機會。

Furoscix ReadyFlow, which we have a CVR around because of the meaningful contribution this will have to the important growth of this franchise and finally, the Phase 1B readout and attentive DPI in patients with IPF and underlying lung disease.

Furoscix ReadyFlow（我們對此設有 CVR），因為它將對該產品線的重要成長做出顯著貢獻；最後是第 1B 期讀出，以及在 IPF 與基礎肺部疾病患者中的 attentive DPI。

These three things contribute to a solid foundation as we close out 2026 and move into 2027.

這三項因素在我們結束 2026 年並邁入 2027 年之際，奠定了穩固的基礎。

Beyond the catalysts. This presses off to a very strong start.

除了這些催化劑之外。這也讓我們有一個非常強勁的開局。

Our TOP20 key institutions have already written a prescription.

我們 TOP20 的關鍵機構已經開出處方。

Breakthrough T1D acknowledged the importance of this opportunity by funding a grant to go after insulin newly diagnosed patients.

Breakthrough T1D 也透過資助一項補助金，肯定了這個機會的重要性，用於推動新診斷的胰島素患者。

Furoscix showed strong revenue growth with 43% growth just over Q1 and our Phase II inflow study has kicked off and underway with multiple shots on goal in front of us between Tyvaso DPI or Lenipeg DPI and now Natania DPI all focused on IPF disease.

Furoscix 的營收呈現強勁成長，較第一季成長 43%；我們的第二期 inflow 研究已啟動並正在進行中；同時我們在 IPF 疾病上也有多個「射門機會」，包括 Tyvaso DPI 或 Lenipeg DPI，以及現在的 Natania DPI，皆聚焦於 IPF。

As you look at Q2 revenues, we grew 21% from Q1 '26 to Q2 '26. What's most important about this picture is when you double-click down.

從第二季營收來看，我們從 2026 年第一季到第二季成長了 21%。這張圖最重要之處在於，當你進一步深入檢視時。

Marketed products grew 27% quarter over quarter where royalties declined 1% from Q1 to Q2. When you take out our collaboration service revenue, you can really see an underlying picture of what's driving our growth quarter to quarter.

已上市產品（marketed products）季對季成長 27%，而權利金（royalties）從第一季到第二季下滑 1%。當你扣除合作與服務收入後，就能更清楚看到推動我們季對季成長的基本面。

Now let me talk about our first tier revenue mix evolution as we look at the success of our diversification strategy that we laid out. When you take out that collaboration and service revenue, we grew 111% on marketed products year-over-year.

接著我想談談第一層級（first tier）營收組合的演變，以檢視我們所提出之多元化策略的成功。當你扣除合作與服務收入後，我們的已上市產品年對年成長 111%。

This is obviously driven by the shift of Huro6 and you can see that the royalties remain a durable revenue stream for years to come. But the predominant revenue growth of mankind is being driven by marketed products and this crossed the threshold in Q2 from Q1. Where our two marketed products now demonstrate faster growth and a higher percentage of our revenue over the royalties by themselves.

這顯然是由 Huro6 的轉移所帶動，你也可以看到權利金仍將在未來多年維持為一項穩健的收入來源。但 MannKind 的主要營收成長動能來自已上市產品，且在第二季相較第一季已跨過門檻。我們的兩項已上市產品如今展現更快的成長，且其營收占比已高於單純的權利金。

The royalties provided great strong base business as we go forward into our launch trajectories.

權利金為我們在推進各項上市軌跡時，提供了非常穩固的基礎業務。

Let me talk about the launch of Afrezza Pediatrics, which many of you have been asking us about.

接下來談談 Afrezza 兒科上市，這也是許多人一直在詢問的主題。

Now that we're approved, this is the first alternative mealtime injection in over 100 years.

現在我們已獲核准，這是 100 多年來第一個可替代餐時注射的選擇。

This product is solving an unmet need and a challenge that parents and patients face when it comes to timing of administration and seeing the impact that insulin has on their sugars and their CGM.

本產品正在解決一項未被滿足的需求，以及家長與患者在給藥時機、以及觀察胰島素對血糖與其 CGM 影響時所面臨的挑戰。

Seeing the ultra rapid effect of Afrezza, the earlier peak, and the tail coming off allows patients to dose differently and treat their sugars in a way that they just cannot achieve with insulin pumps or injectable insulin.

Afrezza 的超速效作用、更早的峰值以及尾端效應的消退，使患者能以不同方式給藥，並以胰島素幫浦或注射胰島素無法達成的方式來控制血糖。

This is now backed by more than a decade of safety data on the market, clear commercial opportunity and access at $35 opens up the door for many patients to start this therapy.

此外，這項療法已有超過十年的上市安全性資料支持，具備明確的商業機會；而以 35 美元的可近性（access）也為許多患者開啟了開始此療法的大門。

One of the main questions we get is why do we believe Afrezza will be different in pediatrics than the adult segment?

我們最常被問到的問題之一是：為什麼我們相信 Afrezza 在兒科市場會與成人市場不同？

First, at the top left, a concentrated, targetable, addressable market. When you think about the adult prescriber base, there are 60,000 adult prescribers that make up 80% of rapid acting scripts. Which include a lot of type two patients.

第一，在左上角，是一個集中、可鎖定、可觸及的市場。談到成人處方醫師基礎，有 60,000 名成人處方醫師開出 80% 的速效胰島素處方。其中包含許多第二型糖尿病患者。

We pivoted about it over a year ago to type one. The pediatric prescribers, about 1,000 prescribers make up 80% and are predominantly institutional based.

我們在一年多前已將重心轉向第一型。兒科處方醫師方面，約 1,000 名處方醫師開出 80% 的處方，且主要以機構為主。

Second, there's a connected patient-centric community. We see this online, we see it on Instagram, we see it in education and nurse educators.

第二，存在一個彼此連結、以患者為中心的社群。我們在線上、Instagram、教育活動以及護理衛教師中都看得到。

The adults, we only targeted prescribers there is limited surround sound of patients, but the pediatric segment and the success we've had, we've seen noise come from caregivers, from CDEs, school nurses, influencers, and advocacy organizations across the board, driving a lot of demand and questions into the pediatric community.

在成人市場，我們只鎖定處方醫師，患者端的環繞聲量有限；但在兒科市場以及我們目前的成功中，我們看到照護者、CDE、校護、意見領袖與倡議組織等各方都發出聲量，推動了大量需求與問題湧入兒科社群。

Third, in the bottom left, a stronger clinical foundation and KOL support. When we launched with the adults, we had two studies published and not a lot of top KOL support. As you look at pediatrics, we have some of the top world-renowned thought leaders talking about our data, talking about the unmet need, and the solutions that a Fresno can bring to pediatrics.

第三，在左下角，是更強的臨床基礎與 KOL 支持。我們在成人市場上市時，只有兩篇研究發表，且頂尖 KOL 支持不多。而在兒科方面，我們有一些世界頂尖、享譽國際的意見領袖在討論我們的數據、未被滿足的需求，以及 Afrezza 能為兒科帶來的解決方案。

This is followed by 10 years of safety on the market, new ADA guidelines, the INHALE-1 trial, as well as the INHALE-1 trial being done in the TOP50, 60 centers across the US between all of our pediatric development.

此外還有 10 年的上市安全性資料、新的 ADA 指引、INHALE-1 試驗，以及 INHALE-1 試驗在美國 TOP50、60 個中心進行，涵蓋我們所有的兒科開發。

And then finally is removing friction. We know access is a hurdle for any new launch, and we've basically taken the opportunity to take away all objections around access, FEV1, and providing point of care opportunities to make sure patients can have a frictionless, seamless experience when they go to start Afrezza.

最後是降低摩擦。我們知道可近性（access）是任何新上市的門檻，因此我們基本上把握機會，移除所有與可近性、FEV1 以及提供照護現場（point of care）機會相關的反對理由，確保患者在開始使用 Afrezza 時能有低摩擦、無縫的體驗。

The first eight weeks support these four pillars are driving a different uptake curve than adults.

前八週的表現顯示，這四大支柱正推動一條與成人不同的採用曲線。

When I look at the names of the institutions on this slide.

當我看這張投影片上的機構名稱時。

These are some of the top centers in the country that treat the biggest volume of patients. In fact, one in three of the TOP100 pediatric rapid acting writers have already prescribed Afrezza.

這些是全國一些治療患者量最大的頂尖中心。事實上，TOP100 兒科速效胰島素處方者中，每三位就有一位已經開立 Afrezza。

We have 20 priority counts and all 20 have written at least one prescription since launch.

我們有20個優先目標客戶，而這20個客戶自上市以來都至少開立過一張處方。

We're really excited by these early metrics and we'll continue to keep you posted as we go forward. And before I close on the pediatric launch, I want to talk about the media coverage has really helped convert early momentum.

我們對這些早期指標感到非常振奮，並將在後續進展中持續向各位更新。在我結束兒科上市的部分之前，我想談談媒體報導如何真正幫助我們把早期動能轉化為實際成效。

Over 200 markets in all 50 states got episodes on CBS and ABC as well as numerous articles highlighting the new innovation in pediatrics. This has signaled more demand from HCPs and patients and awareness than we expected. And this media credibility is fueling real-world engagement, social conversations and pull-through opportunities that we didn't have otherwise.

全美50州超過200個市場在CBS與ABC播出相關專題，同時也有多篇文章聚焦兒科領域的新創新。這使得醫療照護專業人員（HCP）與病患端的需求與認知度都高於我們原先預期。而這樣的媒體公信力正在帶動真實世界的互動、社群討論，以及我們原本不具備的帶動處方延伸（pull-through）機會。

As I think about the roadmap to success, Afrezza's future includes additional product development, digital advancement and external innovation.

在我思考成功路線圖時，Afrezza的未來包含更多產品開發、數位化推進以及外部創新。

Today, we have updated FDA approved dose conversion in 2026. We have new guidelines support and now we have the pediatric approval providing a foundation for global expansion and opportunity.

今天，我們已更新FDA核准的劑量換算，將於2026年生效。我們也獲得新的指引支持，而兒科適應症核准則為全球擴張與機會奠定了基礎。

As we look to 2027, we expect to be able to introduce a two-unit cartridge and Inhale IQ, which will be a Bluetooth-connected device integrated with CGM.

展望2027年，我們預期能推出兩單位（two-unit）藥匣以及Inhale IQ；後者將是一款可透過藍牙連線、並與CGM整合的裝置。

And then as we approach 2028, we expect to be able to have high concentration formulations of Afrezza, which ultimately will enable higher doses and lower powder loads at the current doses, minimizing any cough opportunity and increasing cost-effectiveness as we get to higher doses in type 2.

接著在接近2028年時，我們預期能推出Afrezza的高濃度配方；這最終將在目前劑量下實現更高劑量與更低粉末負載，將任何咳嗽發生的可能性降到最低，並在第二型糖尿病需要更高劑量時提升成本效益。

Now let me bridge the FDA approval of the Furoscix ReadyFlow.

現在讓我銜接到FuroScix ReadyFlow的FDA核准。

As we know, fluid overload across the patient journey. Is often something that happens at moments in time. The majority of patients can be stable on an oral diuretic at home.

如我們所知，液體負荷過多會貫穿病患整個治療旅程。這通常是在某些特定時點發生的狀況。多數病患在家中使用口服利尿劑即可維持穩定。

Oftentimes though these patients will start to have fluid overload and edema and in the gut it stops the absorption of not only the diuretic but also the other meds to treat heart failure causing a compound effect and worsening of this condition for patients.

然而，這些病患常常會開始出現液體負荷過多與水腫，而腸胃道水腫會阻礙不僅是利尿劑、也包括其他治療心衰竭藥物的吸收，造成複合效應，讓病患病況惡化。

We often hope that FuroScix in the majority of our use today is in this early intervention stage in the community setting where we can hopefully prevent patients from going to the and progressing.

我們常希望FuroScix在目前多數使用情境中，能用於社區端的早期介入階段，讓我們有機會避免病患前往醫院並進一步惡化。

The opportunity we see tomorrow, especially with this ReadyFlow, is the post-hospital discharge, i.e., can we get patients out of the hospital sooner that are stable or reduce free admissions to prevent the 30-day penalty that many hospitals get for not completely drying out patients before discharge?

我們明天看到的機會，特別是有了這個ReadyFlow之後，是出院後的情境；也就是說，我們能否讓已穩定的病患更早出院，或減少再入院，以避免許多醫院因為出院前未能讓病患充分脫水（dry out）而面臨30天再入院罰款？

We see an opportunity here to increase intervention in the early stage, as well as start to continue to get post-discharge protocols across the top health systems in the U.S. Since Q1, Mankind advanced several key FuroScix growth opportunities.

我們看到一個機會：在早期階段增加介入，同時也開始在美國頂尖醫療體系中推動出院後照護流程。自第一季以來，MannKind推進了數項FuroScix的關鍵成長機會。

First, we highlight a limited hospital presence. We increased our IDN engagement in hospital systems to drive stronger hospital pull-through. And as we see, our medical liaisons are engaging at the highest level on institution protocol development and discharge, as well as our key account managers working with institutions in quality, purchasing, and pharmacy to drive continued contracts and growth opportunities across these IDNs. We saw 36% growth in Q2 over Q1.

首先，我們強調目前在醫院端的覆蓋仍有限。我們提升了在醫院體系中的IDN互動，以帶動更強的院內帶動處方延伸（pull-through）。如各位所見，我們的醫學聯絡員正以最高層級參與機構端流程制定與出院規範；同時，我們的關鍵客戶經理也與機構在品質、採購與藥局等部門合作，推動在這些IDN中的持續合約與成長機會。我們在第二季相較第一季成長了36%。

The team is really focused on trying to launch nephrology while continuing to deliver cardiology sales. We were able to separate those sales force opportunities this year and we caused some disruption here in Q1, but you can start to see the impact of that effort here in Q2 with 67% growth in nephrology in Q2 over Q1 and a record number of prescribers.

團隊非常專注於在持續推進心臟科銷售的同時，嘗試啟動腎臟科上市。今年我們得以將這兩個銷售團隊的機會區隔開來，第一季因此造成一些擾動，但各位可以在第二季開始看到這項努力的影響：第二季腎臟科相較第一季成長67%，且處方醫師數創下新高。

The next is underfunded marketing spend. So we made many changes to our marketing investments and you'll start to see those in the second-half of this year as we prepare for the FuroScix ReadyFlow launch.

下一項是行銷投入不足。因此我們對行銷投資做了許多調整，隨著我們為FuroScix ReadyFlow上市做準備，各位將在今年下半年開始看到這些變化。

We believe those investments will continue to accelerate growth as we close out '26 and position ourselves for 2027.

我們相信這些投資將在我們邁向2026年底時持續加速成長，並為2027年做好定位。

So what does ReadyFlow approval now mean?

那麼，ReadyFlow核准現在代表什麼？

First, it's the only IV equivalent diuretic delivered via an auto injector.

第一，它是唯一透過自動注射器給藥、且療效等同靜脈注射（IV）的利尿劑。

This will be available in the next three weeks to key institutions and community prescribers. This will allow us to deliver treatment from a matter of hours to seconds.

它將在接下來三週內提供給關鍵機構與社區端處方醫師。這將使我們把治療給藥時間從以「小時」計縮短到以「秒」計。

It's demonstrated equivalent urine output, sodium excretion, and potassium excretion to IV furosemide in healthy volunteers. The safety profile is consistent with oral and IV furosemide, and the symptom relief may begin in an hour or less. This is a really exciting opportunity to help patients prevent them from going into the hospital or hopefully getting them out of the hospital early or preventing those one in four patients from going back in.

在健康受試者中，它已證實在尿量、鈉排泄與鉀排泄方面與靜脈注射呋塞米（IV furosemide）等效。其安全性概況與口服及靜脈注射呋塞米一致，且症狀緩解可能在一小時內或更短時間開始。這是一個非常令人振奮的機會，可協助病患避免住院，或希望讓他們更早出院，或避免每四位就有一位病患再次入院。

The FuroScix ReadyFlow launch campaign is built to drive immediate awareness and adoption and we're looking at field activation immediately along with integrated surround sound at the major health systems and opportunities where patients are showing up in these health systems as well as online with the prescribers and patients.

FuroScix ReadyFlow的上市行銷活動旨在推動即時的認知與採用；我們將立即啟動第一線推廣，同時在主要醫療體系中進行整合式的全方位曝光（surround sound），鎖定病患在這些醫療體系就醫的接觸點，以及線上端的處方醫師與病患。

We're excited to be present at these upcoming conferences in the fall. We expect the awareness of Hero6 ReadyFlow to immediately take off in the coming weeks.

我們也很期待在秋季即將到來的這些會議中亮相。我們預期Hero6 ReadyFlow的知名度將在未來幾週內立即起飛。

Now I'm going to bridge to an attentive DPI.

接下來我將銜接到一個吸入式DPI。

This is an exciting opportunity where we just had a quick update last week and we kind of walked you through the totality of the program and today I'm just going to give you a few key highlights. Number one. Our positive Phase 1b study demonstrated safety and tolerability in patients with IPF.

這是一個令人振奮的機會；我們上週剛做了快速更新，並帶各位走過整個計畫的全貌，而今天我只會提供幾個重點。第一點。我們正向的1b期研究在IPF病患中證實了安全性與耐受性。

We saw no serious adverse events, no GI burden, no discontinuations due to safety, and no difference in spirometry parameters between placebo, which is an empty cartridge, and the [tetanin] DPI.

我們未觀察到嚴重不良事件、沒有腸胃道負擔、沒有因安全性而停藥的案例，且在肺量計參數上，安慰劑（空藥匣）與[tetanin] DPI之間沒有差異。

Our Phase 2 study is underway. Our first patient has been dosed, and we expect to continue to activate sites around the world and throughout 2026.

我們的2期研究正在進行中。第一位病患已完成給藥，我們預期將在全球持續啟動研究中心，並延續至2026年。

One of the things I want to highlight before we talk about the PK/PD is that C-max is known to drive efficacy in pulmonary fibrosis. This means AUC is less of a driver in terms of the Tepotinib efficacy and hitting a peak threshold concentration matters more than total lung exposure.

在我們談PK/PD之前，我想先強調一點：在肺纖維化中，C-max被認為是驅動療效的關鍵。這表示就Tepotinib的療效而言，AUC的驅動性較低；相較於總肺部暴露量，達到峰值閾值濃度更為重要。

Beyond the peak, more exposure adds very little added benefit and this is one of the challenges you have with oral delivery product is it's very hard to get high tissue levels in the lungs.

超過峰值之後，增加暴露量帶來的額外效益非常有限；而口服給藥產品的一個挑戰在於，很難在肺部達到高組織濃度。

We've known from our preclinical work that we can see significantly higher lung concentrations than plasma by targeting the lungs directly.

我們從臨床前研究已知，透過直接鎖定肺部，我們可以看到顯著高於血漿的肺部濃度。

So we believe that brief high peaks are sufficient with short bursts of high concentration to inhibit fibrotic pathways is the data that's been generated out there today on the [tetanib].

因此我們相信，短暫的高峰值已足夠；以短時間的高濃度脈衝來抑制纖維化途徑，這也是目前外部針對[tetanib]所產生的數據所支持的結論。

Now as I move into our own program, let me talk about the data we have.

接著談到我們自己的計畫，我來說明我們掌握的數據。

Our Phase 1a. Validated efficient deep lung delivery of the tentative DPI.We had rapid dose proportional exposure and a favorable safety profile in our healthy volunteer data.

我們的1a期。驗證了該DPI可有效遞送至肺部深處。我們在健康受試者數據中觀察到快速且與劑量成比例的暴露量，以及良好的安全性概況。

When you look at our phase 1a study, significantly six to eight fold higher concentration on Cmax in our phase one study compared to a study out there that's been published in nebulized treatment.

當你看我們的第 1a 期研究時，與已發表的霧化治療研究相比，我們第 1 期研究的 Cmax 濃度顯著高出 6 到 8 倍。

When you look at the data on the right. Our seven-day treatment shows you a dose proportional response when you zoom in on the key attribute here as we're looking at Cmax and AUC.

當你看右側的數據。我們的 7 天治療顯示出劑量成比例的反應，當你聚焦在這裡的關鍵屬性、也就是 Cmax 與 AUC 時更為明顯。

Now let me walk you through the data we just released last week. For those that didn't see it, this was the first inpatient study to assess safety, tolerability, and PK in patients with underlying IPF.

現在我帶各位看一下我們上週剛發布的數據。如果有人沒看到，這是第一項住院研究，用於評估具有潛在 IPF 的患者之安全性、耐受性與藥物動力學（PK）。

This was a two cohort multiple sending dose study where cohort one got two milligrams three times a day, and cohort two got four milligrams twice a day delivered as two milligram cartridge, i.e., a patient took four cartridges a day in cohort two.

這是一項兩個隊列的多次給藥劑量研究：隊列一每日三次、每次 2 毫克；隊列二每日兩次、每次 4 毫克，以 2 毫克藥匣給藥，也就是隊列二的患者每天使用 4 個藥匣。

When you look at the baseline characteristics, the age was 73. Females were 37%. And the pulmonary function of baseline is consistent with what you'd expect in this population with an FEV1 of almost two liters.

從基線特徵來看，年齡為 73 歲。女性占 37%。基線肺功能與你對此族群的預期一致，FEV1 接近 2 公升。

So in our Phase 1b study in patients with underlying IPF, we saw a clean safety profile with zero safety signals, zero bronchospasms, and zero discontinuations or down doses.

因此，在我們針對具有潛在 IPF 患者的第 1b 期研究中，我們看到乾淨的安全性概況：零安全性訊號、零支氣管痙攣，且零停藥或降劑量。

This becomes a challenge when you think about discontinuations with oral therapy can be as high as 50%. This overall profile supports chronic use and de-risks our program as it advances into Phase 2.

當你想到口服治療的停藥率可能高達 50% 時，這就成為一項挑戰。這樣的整體概況支持長期使用，並在我們推進至第 2 期時降低計畫風險。

Now let me double click down on the overall treatment adverse events, which was one of the questions we got post our call last week and as you can see here, as previously stated, cough was about 39% in this trial. But there's no other single adverse event that really showed any concerns as we look at safety and tolerability in the placebo group or the active group.

接著我再深入說明整體治療相關不良事件，這也是我們上週電話會議後收到的問題之一；如你在此所見，如先前所述，本試驗咳嗽約占 39%。但在安慰劑組或治療組中，沒有任何其他單一不良事件在安全性與耐受性方面顯示出真正的疑慮。

So now let me double click down on the cough. There were no discontinuations and no serious adverse events.

那麼我再深入談咳嗽。沒有停藥，也沒有嚴重不良事件。

As I stated, 60% of patients had no cough post-inhalation and about 30% of patients had a mild cough. This mild cough is considered transient, does not progress over time and basically is something that gets better with time as people use the product. So we think about 90% of patients had very mild cough and none of these were severe.

如我所述，60% 的患者在吸入後沒有咳嗽，約 30% 的患者出現輕微咳嗽。這種輕微咳嗽被視為短暫性的，不會隨時間惡化，基本上會隨著使用產品而逐漸改善。因此我們認為約 90% 的患者僅有非常輕微的咳嗽，且沒有任何一例為嚴重。

The cough typically happens with the first dose and does not worsen with time and this is not a product that you're going to continue to increase the dose over time, so we do not expect the cough to change from this first seven days of treatment.

咳嗽通常發生在第一劑，且不會隨時間加重；而且這不是一種會隨時間持續加量的產品，因此我們不預期咳嗽會在這最初 7 天治療之後有所改變。

There were 450 doses administered over seven days in patients with IPF, and not one patient had the dose reduce due to the powder load or the cough from the powder itself. We're really proud of these results, and we're not surprised given that Technosphere powders. Have been studied in thousands of patients, and we've seen very low single-digit discontinuations through the cough.

在 IPF 患者 7 天內共給予 450 次劑量，沒有任何患者因粉末負載或粉末本身引起的咳嗽而需要減量。我們對這些結果非常自豪，而且並不意外，因為 Technosphere 粉末。已在數千名患者中研究過，我們看到因咳嗽而停藥的比例一直維持在非常低的個位數。

Now I'm going to turn it over to Chris for our financial results.

接下來我把時間交給 Chris，說明我們的財務結果。

Thanks, Mike, and good afternoon, everyone.

謝謝你，Mike，各位下午好。

Second quarter revenue was $109.4 million, up 43% year-over-year, and first half revenue reached $199.5 million, up 29% over the first half revenue of 2025.

第二季營收為 1.094 億美元，年增 43%；上半年營收達 1.995 億美元，較 2025 年上半年營收成長 29%。

At the product level, Afrezza generated $17 million in net sales. Once we are through the initial launch phase for the pediatric opportunity, we intend to provide separate visibility into adult and pediatric performance metrics.

在產品層面，Afrezza 淨銷售額為 1,700 萬美元。一旦我們度過兒科機會的初期上市階段，我們打算分別揭露成人與兒科的表現指標，以提高可見度。

As you would expect, because the pediatric indication was approved on May 29, the quarter included only a limited period of pediatric launch activity.

如你所預期，由於兒科適應症於 5 月 29 日獲批，本季僅包含有限期間的兒科上市活動。

Furoscix generated $22.2 million in net sales, an increase of 43% from the first quarter.

Furoscix 淨銷售額為 2,220 萬美元，較第一季成長 43%。

This was driven by a 49% increase in units sold, with the offset due to an increase in gross to net adjustments, which were 29% for the current quarter.

這主要由銷售單位數增加 49% 所帶動；但部分被總額到淨額（gross-to-net）調整增加所抵銷，本季該調整為 29%。

As we acquired Furoscix in October 2025, we are not making prior year comparisons.

由於我們於 2025 年 10 月收購 Furoscix，因此不進行與前一年度的比較。

Our United Therapeutics revenue streams also continued to provide a meaningful contribution.

我們來自 United Therapeutics 的營收來源也持續提供顯著貢獻。

Royalty revenue increased 4% over the second quarter of 2025 to $32.4 million, while collaboration and services revenue increased 53% to $35 million.

權利金收入較 2025 年第二季增加 4% 至 3,240 萬美元，而合作與服務收入增加 53% 至 3,500 萬美元。

The increase in collaboration revenue was primarily attributable to a higher volume of products sold through to United Therapeutics and to a lesser extent price.

合作收入的增加主要歸因於銷售給 United Therapeutics 的產品出貨量提高，價格因素的影響則較小。

In addition, we recognized $4.9 million of revenue associated with Ralenipeg DPI development milestones during the quarter.

此外，我們在本季認列了與 Ralenipeg DPI 開發里程碑相關的 490 萬美元收入。

As we've noted previously, this revenue stream may fluctuate between periods depending on production scheduling at our Danbury facility across Afrezza, our development programs and Tavaso DPI.

如我們先前所提，該收入來源可能會因我們丹伯里（Danbury）廠在 Afrezza、我們的開發計畫以及 Tavaso DPI 之間的生產排程而在各期間波動。

Based on our production plans, we expect Q2 to be the highest quarter of manufacturing-related revenues. With the annual revenues in line with the prior year.

根據我們的生產計畫，我們預期第二季將是製造相關收入最高的一季。全年收入將與前一年一致。

Overall, the quarter reflects increasing revenue diversification from our promoted commercial products relative to our stable base of UT-related revenues.

整體而言，本季反映出相較於穩定的 UT 相關收入基礎，我們所推廣的商業化產品帶來的營收多元化正在提升。

Turning to the bottom line, for the second quarter of 2026, we reported a GAAP net loss of $19 million compared with GAAP net income of $700,000 in the prior year quarter.

接著看損益底線，2026 年第二季我們依 GAAP 報告淨損 1,900 萬美元，相較於去年同期依 GAAP 為淨利 70 萬美元。

Our non-GAAP net loss was $2.7 million compared with non-GAAP net income of $13.9 million in the second quarter of 2025.

我們的非 GAAP 淨損為 270 萬美元，相較於 2025 年第二季非 GAAP 淨利 1,390 萬美元。

The year-over-year change primarily reflects the planned investments to support Furoscix, including the ReadyFlow formulation, the pediatric Afrezza launch. Investment in our MannKind 201 development program and the incremental increase in our cost structure following the SC Pharma acquisition.

年對年的變動主要反映我們為支持 Furoscix（包括 ReadyFlow 配方）、Afrezza 兒科上市所做的計畫性投資。對我們 MannKind 201 開發計畫的投資，以及在收購 SC Pharma 後成本結構的增量增加。

As you review our non-GAAP adjusted net income, I'd like to call out two lines that are new this year.

在你檢視我們的非 GAAP 調整後淨利時，我想特別指出今年新增的兩個項目。

The first is the amortization of acquired intangible assets.

第一個是收購取得之無形資產攤銷。

This relates to our acquisition of the Furoscix OnBody infuser, which is being amortized over its current expected useful life.

這與我們收購 Furoscix OnBody 輸注器有關，並將在其目前預期的使用年限內進行攤銷。

Now that the auto injector has been approved, we will begin to amortize this intangible asset in the third quarter and on a full quarter basis will be approximately $2.2 million.

現在自動注射器已獲核准，我們將在第三季開始攤銷該無形資產，若以完整一季計算，約為 220 萬美元。

It is important to note that the amortization of these intangible assets are non-cash, but we will see these expenses flow through our P&L for many years to come.

需要注意的是，這些無形資產的攤銷屬於非現金項目，但未來多年我們都會在損益表上看到這些費用。

The other new item relates to the accounting for our contingent value right associated primarily with the recent auto injector approval.

另一個新增項目與我們或有價值權（CVR）的會計處理有關，該 CVR 主要與近期自動注射器核准相關。

We will pay out the $45 million CVR in Q3 and the balance of expense, approximately $16 million, will be recorded in the quarter.

我們將在第三季支付 4,500 萬美元的 CVR，而其餘費用餘額約 1,600 萬美元將於該季入帳。

In conjunction with the auto injector approval, we announced a $50 million pipe financing, providing us pro forma cash position at quarter end of $161 million and giving us sufficient cash to pay the CVR and continuing to fully support our two launches and accelerate the development of our 201 program.

配合自動注射器核准，我們宣布了 5,000 萬美元的 PIPE 融資，使我們在季末的備考現金部位為 1.61 億美元，並提供足夠現金支付 CVR，同時持續全力支持兩項上市並加速我們 201 計畫的開發。

On the expense side. R&D expense was $18 million compared with $13.7 million in the prior year quarter.

在費用端。研發費用為1,800萬美元，較去年同期的1,370萬美元增加。

The increase was primarily attributable to development of the Furoscix ReadyFlow formulation, higher personnel costs following the SC Pharma acquisition and increased development costs driven by our Mankind 201 program.

增加主要歸因於Furoscix ReadyFlow配方的開發、SC Pharma收購後較高的人事成本，以及由我們的Mankind 201計畫帶動的開發成本上升。

SG&A expense was $58.3 million. Compared with $31.6 million in the prior year quarter.

銷售、一般及行政（SG&A）費用為5,830萬美元。相較於去年同期的3,160萬美元。

The increase primarily reflected the promotion and support of Furoscix , as well as the expansion of our field-based teams and activities to support the pediatric Afrezza and Furoscix ReadyFlow launches.

增加主要反映Furoscix的推廣與支援，以及我們擴大外勤團隊與相關活動，以支援兒科Afrezza與Furoscix ReadyFlow的上市。

As we discussed last quarter, 2026 is a deliberate investment year, with both approvals now achieved. Our focus has shifted from launch preparation to disciplined execution.

如同我們上季所討論的，2026年是刻意投資的一年，且目前兩項核准都已取得。我們的重心已從上市準備轉向有紀律的執行。

We will continue to monitor performance, prioritize investments behind the opportunities, showing the strongest returns and appropriately managing our cost structure.

我們將持續監測表現，優先將投資配置在回報最強的機會上，並適當管理我們的成本結構。

Before I hand it back to Mike, I want to mention that we'll be participating in the Wells Fargo Annual Healthcare Conference in Boston, as well as the Canter Global Healthcare Conference, and the HC Wainwright Global Investment Conference in New York.

在我把電話交回給Mike之前，我想提一下，我們將參加在波士頓舉行的Wells Fargo年度醫療保健大會，以及Canter全球醫療保健大會，還有在紐約舉行的HC Wainwright全球投資大會。

We look forward to engaging with many of you there.

我們期待在那裡與各位中的許多人交流。

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

那麼，我把電話交回給Mike。

Thanks, Chris. Let me close with where this leaves us.

謝謝，Chris。我用我們目前的狀況作個結尾。

I told you at the start of this year that three catalysts would define 2026 for mankind, and we delivered on all three.

我在今年年初就告訴各位，有三個催化劑將定義Mankind的2026年，而我們三項都已達成。

Afrezza has proved in pediatrics and is launching well.

Afrezza已在兒科證實其效益，且上市進展良好。

Furoscix ReadyFlow is now approved and will be available by the end of this month.

Furoscix ReadyFlow現已獲核准，並將於本月底前可供使用。

And the tentative DPI showed positive results in Phase 1 with IPF patients, which validated our continued Phase 2 advancement and investment.

而tenta tive DPI在IPF患者的第一期試驗中顯示正面結果，驗證了我們持續推進至第二期並投入資源的合理性。

Our job for the rest of this year is execution, and we have the team, the products, and the evidence to make it all happen.

我們今年剩下的工作就是執行，而我們具備團隊、產品與證據，能把這一切落實。

Before we take questions, a quick note on where our teams will be this week.

在我們開始提問之前，先簡短說明一下我們團隊本週的行程。

First starting out, ADCS, which is the CDE conference.

首先是ADCS，也就是CDE會議。

And this fall, we'll have a presence at major heart failure and nephrology meetings, HFSA and ASN and the last one I'd like to flag with you is ISPAD in November, where our INHALE First pilot-based findings were selected for two oral presentations.

而在今年秋季，我們將出席主要的心衰與腎臟醫學會議，包括HFSA與ASN；另外我想特別提醒各位的是11月的ISPAD，我們的INHALE First以試點為基礎的研究結果獲選進行兩場口頭報告。

As the pediatric diabetes community's own meeting and having our newly diagnosed data presented there.

作為兒科糖尿病社群自己的會議，並在那裡發表我們新診斷患者的數據。

Is meaningful for how this therapy gets understood by the clinicians who will drive its use potentially around the world.

這對於讓將可能在全球推動其使用的臨床醫師理解這項療法，具有重要意義。

With that, operator, we'll now turn the call over for questions.

那麼，接線員，現在我們把電話交給提問環節。

Thank you. The floor is now open for questions. (Operator Instructions)

謝謝。現在開放提問。(接線員指示)

Our first question will come from Ben Burnett from Wells Fargo.

我們的第一個問題來自Wells Fargo的Ben Burnett。

You may now unmute your line and ask your question.

您現在可以解除靜音並提出問題。

Thanks so much, and congrats on the progress.

非常感謝，也恭喜你們的進展。

I wanted to ask about Afrezza.

我想問關於Afrezza。

You conveyed some good early momentum. I guess what proportion of scripts that you're seeing are coming through your cash program?

你們提到早期動能不錯。我想了解一下，你們目前看到的處方中，有多大比例是透過你們的現金方案（cash program）取得的？

And do you expect these patients will convert to more standard channels? And if so, kind of when would you expect that?

你們是否預期這些患者會轉向較標準的通路？如果會，大概預期在什麼時點？

Thank you, Ben, and it's great to hear from you. When we look at all the scripts dispensed, we're still because we got the hub and then we have some IQV data we're reconciling, but we are seeing a good portion go through as fully paid and we're. The other half at least go through is cash.

謝謝你，Ben，很高興聽到你的聲音。就所有已配藥的處方來看，因為我們有hub資料，另外也有一些IQV資料正在對帳，但我們確實看到相當一部分是以全額支付方式進行，而我們……至少另一半是走現金支付。

It's too early to tell how quickly that will convert, but obviously we're pursuing the prior authorizations and the appeals to make sure patients get it, and in parallel, we're also meeting with payers as we're trying to continue to increase cost and coverage for patients, especially as we go into '27.

目前還太早判斷轉換速度會有多快，但很明顯我們正在推進事前授權（prior authorizations）與申訴（appeals），以確保患者能取得藥物；同時，我們也正與付款方會面，持續努力提升患者的可負擔性與保險涵蓋，特別是在邁入'27之際。

This program is going to go through the end of '26 and we would hope by then we work through most of the payers to move forward there. So far, I can tell you our pediatric approval rates are consistent with the adult approval rates and so that's one indicator of what we're looking at. But otherwise, there is more than half going through is cash, but we expect many of those to convert to paid.

這個方案會持續到'26年底，我們希望到那時能與大多數付款方完成協商並往前推進。目前我可以告訴各位，我們的兒科核准率與成人核准率一致，這是我們觀察的一個指標。除此之外，走現金支付的比例超過一半，但我們預期其中許多會轉為由保險支付。

Our next question comes from Olivia Saunders from Canter.

下一個問題來自Canter的Olivia Saunders。

Hey, good afternoon, guys.

嗨，大家午安。

Thank you for the question.

謝謝讓我提問。

I know it's obviously very early in development still, but can you maybe help walk us through how you're thinking about the regulatory path forward for your IPF program? Obviously, the ongoing Phase 2 will be a big part of that, but what feedback have you gotten maybe more recently from the FDA around what you'll need to get this to patients and whether there are things that you can do to help accelerate that path forward?

我知道這顯然仍處於非常早期的開發階段，但你們能否說明一下，你們如何看待IPF計畫未來的法規路徑？顯然正在進行的第二期會是其中很重要的一部分，但你們最近從FDA那邊得到哪些回饋，關於要如何讓這項療法提供給患者，以及是否有什麼作法可以幫助加速後續路徑？

And then as a follow-up.

另外作為追問。

Is PPF something that you guys are looking into at this point as you think about your long-term portfolio, just given how big of a market it is and how much R&D interest there seems to be around it right now?

在你們思考長期產品組合時，目前是否也在評估PPF？考量到它的市場規模很大，而且目前看起來研發關注度也很高。

Thank you, Olivia, and great questions. Obviously, we're very excited about just an attended IPF opportunity. But to your point, we will continue to look at IPF, PPF, ILD and all the indications related to an attended. We did meet the FDA last year as we finished up our Phase I to go to Phase II. We originally proposed a Phase III study because most of the time in starting these trials is site activations and we're trying to minimize that and at that point, that's why we decided to do the Phase 1b to minimize any distraction related to FDA feedback.

謝謝你，Olivia，問題很棒。顯然，我們對於一個可被滿足的IPF機會感到非常興奮。但如你所說，我們也會持續關注IPF、PPF、ILD以及所有與「attended」相關的適應症。我們在去年完成第一期並準備進入第二期時，曾與FDA會面。我們原本提議進行第三期研究，因為啟動這些試驗的大部分時間都花在試驗中心啟用上，我們希望將其降到最低；因此當時我們決定先做1b期，以降低任何與FDA回饋相關的干擾。

They really wanted to know what the patterns look like in patients with IPF. We've now demonstrated that. We have submitted the Phase II protocol to the FDA to open up potential US sites. And we'll have feedback on that in the fall.

他們非常想了解IPF患者的模式（patterns）會是什麼樣子。我們現在已經證明了這一點。我們已將第二期試驗方案提交給FDA，以開放潛在的美國試驗中心。我們將在秋季收到相關回饋。

I think you've seen the FDA kind of indicate probably one trial is probably all that will be required in addition to the Phase II. And that's our underlying assumption. But again, the FDA will have to confirm some of those.

我想你也看到FDA某種程度上表示，除了第二期之外，可能只需要再做一項試驗即可。這也是我們的基本假設。但同樣地，FDA仍需確認其中一些事項。

And I think depending on the significant effect size that we may or may not see, that's probably going to drive some of those other indication extrapolation discussions versus do you need additional studies.

而我認為，取決於我們可能看到或可能看不到的顯著效應量（effect size），這很可能會推動後續關於其他適應症外推（indication extrapolation）的討論，或是是否需要額外研究。

The pulmonary division is very different than the other divisions, and so I think it's still TBD, but we're going to learn, like you see on TAVIS, so DPI as UT talks to the FD, we'll learn things there, and there was indication extrapolation in DPI for ILD.

肺科審查部門與其他部門非常不同，所以我認為目前仍有待確定（TBD）；但我們會持續學習，就像你在TAVIS上看到的那樣，因此當DPI作為UT與FDA溝通時，我們也會從中學到一些事情，而且在DPI針對ILD方面曾有適應症外推。

And I think UT still needs to work through that on Tyvaso DPI. So a lot of precedent setting around this set of patients and unmet need. And I think a lot of it with the FDA will determine the effect size and how much they understand this. But too early to tell is it two trials, one trial, each indication extrapolation. But our working assumption is at least one trial for IPF. And likely additional data generated in other target populations, but that's our work and assumption. When we do that in parallel to IPF, I think that's still TBD of how many bets we want to place simultaneously, but we want to make sure we establish the dosing here in Phase 2.

我認為 UT 在 Tyvaso DPI 方面仍需要把這部分釐清並推進。因此，圍繞這一族群與未被滿足的醫療需求，會有許多可作為先例的設定。我也認為，與 FDA 的互動在很大程度上將決定效果量（effect size）以及他們對此的理解程度。但現在還太早，無法判斷會是兩項試驗、一項試驗，或是各適應症之間的外推。不過我們目前的基本假設是：IPF 至少需要一項試驗。而且很可能還需要在其他目標族群產生額外數據，但那是我們的工作與假設。至於是否要與 IPF 並行進行，仍有待決定（TBD），取決於我們想同時下多少注，但我們希望確保在第二期試驗中把劑量先建立起來。

Our next question will come from Rana Ruiz from Leerink. Please unmute the line and ask your question.

下一題來自 Leerink 的 Rana Ruiz。請解除靜音並提問。

Hey, guys, you have Ryan on for Ruana, thanks for taking our question and congrats on the quarter.

嗨，各位，我是代替 Ruana 的 Ryan，謝謝你們回答我們的問題，也恭喜本季表現。

Maybe going back to Afrezza, can you guys just help us understand the pace of script trends that you're seeing in the pediatric setting over the last month or two, as your reps spend more time in the field, are you seeing an acceleration in script or steady growth? And then just as we look out in a couple of quarters and years, how do you expect this mix of adult and pediatric scripts to trend? Thanks.

想回到 Afrezza 的部分，你們能否協助我們理解一下：過去一兩個月在兒科場景中，你們看到的處方（script）趨勢速度如何？隨著你們的業務代表在外勤投入更多時間，你們看到處方加速，還是穩定成長？另外，展望未來幾個季度到幾年，你們預期成人與兒科處方的組合（mix）會如何變化？謝謝。

Thank you, Ryan.

謝謝你，Ryan。

What I'd say is in the first week or two, there was obviously a bolus of patients waiting for approval and we saw really fast submissions and getting those sites on board and our team getting out there to get them to use our reimbursement hub.

我會說，在前一兩週，顯然有一波等待核准的病人湧入，因此我們看到非常快速的送件，並讓那些據點加入，同時我們的團隊也到現場，協助他們使用我們的給付/報銷支援中心（reimbursement hub）。

I've been out there in the field. The excitement is palpable with the customers, the patience, the social media.

我也親自到第一線。從客戶、病患到社群媒體，都能感受到那股興奮。

And you saw kind of even though we had July 4th holidays and people on vacation, we've seen a nice, consistent, steady referral pattern into our reimbursement hub. The last two weeks, you're starting to see that build up with potential refills as well as momentum.

而且你也看到，儘管遇到 7 月 4 日假期、大家在度假，我們仍看到轉介到我們給付/報銷支援中心的模式相當不錯、持續且穩定。過去兩週，你開始看到這個量在堆疊，包含可能的續配（refill）以及動能。

So I expect continued momentum as the quarter and the months progress ahead. And we're also adding.

所以我預期隨著本季與接下來幾個月推進，動能會持續。而且我們也在增加。

Another call 1,000 targets roughly in the pediatric community to our 70 reps who are selling Afrezza for adults. So they will now be kicking in here in August and we're actually be training them next week. So I expect continued momentum building, but it is a nice steady group every week and it has been growing the last few weeks as well.

我們會在兒科社群新增大約 1,000 個目標，交由目前 70 位銷售成人 Afrezza 的業務代表去拜訪。因此他們會在 8 月開始加入推動，我們下週也會對他們進行訓練。所以我預期動能會持續累積；但每週確實是一個穩定的族群，而且過去幾週也在成長。

I think we had our highest week a week and a half ago of the last eight weeks. So. So it is growing and we are hitting new peaks every week and that's exciting and we think we're just getting started here. How that builds will be part of what we're looking for in terms of, obviously you want to know how to build your models, but us too, right? We're making lots of investments here and we want to see how the refill patterns look, how the adult coming in and where are these patients coming from? We just got research this morning. The good news is we're seeing significant number of patients are coming from MDI. They're using it for as a full-time, probably 60%, 70%. And about a third are using it intermittently. And that means they may take a pump break. They may use it on top of their pump.

我想在過去八週中，我們在一週半前出現了最高的一週。所以。所以確實在成長，而且我們每週都在創新高，這很令人振奮，我們也認為這才剛開始。接下來如何發展，是我們要觀察的一部分；當然你們也想知道如何建立模型，但我們也一樣，對吧？我們在這裡投入了很多資源，也想看看續配模式如何、成人端的導入如何，以及這些病人是從哪裡來的。我們今天早上剛拿到研究。好消息是，我們看到相當多病人是從 MDI（每日多次注射）轉來的。他們把它當作全時使用的比例大概 60%、70%。約三分之一則是間歇性使用。這表示他們可能會暫停使用幫浦一段時間。也可能在使用幫浦的同時加用它。

But we are seeing a large percentage of people say they will use it full-time and a lot of good patient demand for it. So that's the overall picture, I'd say, for peds. Happy to dig in in terms of some of our biggest prescribers are asking every patient on every visit. Do you want to try inhaled insulin? And we've seen some people right over 20, 30 patients already.

但我們確實看到有很高比例的人表示會全時使用，且病人端需求相當不錯。所以就兒科而言，整體概況大致如此。如果要更深入，我也很樂意分享：我們一些最大的開立者在每次門診都會問每位病人：你想試試吸入式胰島素嗎？而我們也看到有些醫師已經開給超過 20、30 位病人了。

On the adult side, I want to remind people, we pulled back resources this year on the adults. So obviously, we see a little softness in Afrezza year over year and that's related to really the TOP10 prescribers had a disproportionate amount of decrease relative to the next 1,000 and so, when you take away that TOP10, you look at the underlying adult business, it does look like it hit a nadir here in Q2, Q3, and that momentum in July did start to build back up with new patients growing almost 30% over the month of June. So I do think we'll start to see the compound in the second-half of Afrezza adult and PEDs and if you ask me personally, I think the PEDs response, the uptake, the number of patients coming in, the number of prescribers, the feedback, everything points to PEDs will continue to build momentum and adults, we want to hold steady, and we believe the adult segment will grow with peds and just to give you some color, we had roughly about 450 docs come in since launch that are new prescribers.

在成人端，我想提醒大家，我們今年在成人端縮減了資源。因此，Afrezza 年對年出現一些疲軟是可以理解的，這主要與前 10 大開立者（TOP10）的下滑幅度相對於後面 1,000 位開立者更為不成比例有關；所以當你把 TOP10 拿掉、看成人業務的基本面時，確實看起來在第二季、第三季觸底，而 7 月的動能開始回升，新病人數相較 6 月成長了將近 30%。所以我確實認為，下半年 Afrezza 的成人與兒科會開始形成疊加效應（compound）；如果你問我個人看法，我認為兒科的反應、採用速度、進來的病人數、開立者數、回饋等各方面都顯示兒科會持續累積動能；成人端我們希望維持穩定，我們也相信成人端會隨著兒科一起成長。補充一些背景：自上市以來，我們大約新增了 450 位新的開立醫師。

I'd say and this is just one part of the data, not all the data, but on the conservative side. And of those, about 200 were PEDs and about 250 were adults. So you're seeing more adults coming in with the Peds approval and the confidence and we had about 1800 writers of Afrezza since the June 1 launch. So we're seeing overall writing increase. We're seeing repeat writing increase. We're seeing new writers increase. So that broad base of prescribing, I'll say, is what we're watching and seeing how much we can get depth and breadth of that audience.

我會說，這只是數據的一部分，不是全部數據，但以保守口徑來看。其中約 200 位是兒科，約 250 位是成人。所以你會看到，因為兒科核准與信心提升，成人端也有更多人加入；自 6 月 1 日上市以來，我們大約有 1,800 位 Afrezza 開立者。因此我們看到整體開立量在增加。我們看到重複開立在增加。我們看到新開立者在增加。所以我們正在觀察的，就是這個處方基礎的廣度；並看我們能在這個受眾上取得多少深度與廣度。

Our next question will come from Gregory Renza from Truist Securities. Please unmute your line and ask your question.

下一題來自 Truist Securities 的 Gregory Renza。請解除靜音並提問。

Hey, guys. It's Aneesh on for Greg. Congrats on the quarter and for taking our questions. Just first on the Unipanza peak share source. With the previously quoted 23 to 37 peak share range, how much assumes conversion of pumps and pods versus capture of multiple daily injection patients? And second, on the 201 registrational path or [nintentative]DPI, what is the shortest credible route to approval? Does the study need to show FPC benefit on top of background antifibrotic therapy or non-inferiority to oral [nintentative]? Thanks so much.

嗨，各位。我是代替 Greg 的 Aneesh。恭喜本季，也謝謝你們回答問題。第一題關於 Unipanza 的峰值市佔來源。先前提到的 23% 到 37% 峰值市佔區間中，有多少是假設來自幫浦與 pod 使用者的轉換，相對於擷取每日多次注射病人（MDI）？第二題，關於 201 的註冊性（registrational）路徑或 [nintentative]DPI，最短且可信的核准路徑是什麼？研究是否需要在既有抗纖維化背景治療之上，證明 FPC 的額外效益，或是要對口服[nintentative] 證明非劣性（non-inferiority）？非常感謝。

Okay.

好的。

I'll just keep building on the Afrezza theme, and then I'll jump into 201.

我先延續一下 Afrezza 的主題，然後再談 201。

On the overall data, we would expect roughly half our patients to come from MDI, and maybe 20%, 30% to come off pumps or added to pumps. And then the remaining 15%, 20% be insulin-naive patients. And so that's the segment that we're seeing some early data. We got almost maybe 20% of the naive trial enrolled already. And the two-unit cartridge is really going to be helpful for the naive setting. But I think in terms of MDI and pumps, that's the majority of our patients coming in today are patients coming from MDI for people wanting a pump break. And that's been some of the anecdotal feedback from doctors as they offer it to everybody. They didn't realize that people had burnout and that they're tired and they'd love to be detached from something for a little while. And it doesn't mean they're always going to use a Afrezza full time or a pump full time. They're going to go back and forth realistically depending on their needs.

就整體數據而言，我們預期大約一半的病患會來自 MDI，而可能有 20%、30% 是從胰島素幫浦轉換下來或加用到幫浦治療中。接著其餘的 15%、20% 會是未曾使用胰島素（insulin-naive）的病患。因此，這就是我們目前看到一些早期數據的族群。我們幾乎已經讓未曾使用胰島素的試驗入組了大概 20%。而兩單位的藥匣（cartridge）對於未曾使用胰島素的情境會非常有幫助。但我認為就 MDI 與幫浦而言，今天進來的病患大多數是從 MDI 轉來、想要暫時休息一下幫浦的人。而這也是醫師在把它提供給所有人時所回饋的一些軼聞（anecdotal）意見。他們原本沒意識到有人會倦怠（burnout），會覺得疲累，並且很希望能暫時從某個裝置上解脫一段時間。這並不表示他們永遠都會全職使用 Afrezza 或全職使用幫浦。實際上他們會依照需求在兩者之間來回切換。

So that gives you a breakdown of Afrezza and I would say the research we just got in this morning reiterated that kind of breakdown of what we're seeing in our initial launch assumptions and how it's being used in the first six weeks and how we expect to see that continue on and also the research that came and reiterated the 20%, 30% share that we talked about previously, that the doctors now that that's approval is there, they're continuing to indicate that's a real possibility. So we're continuing to remain bullish and excited here for what we see in the early days, but they'll take time to show these trends.

所以這讓你了解 Afrezza 的組成分布；我會說我們今天早上剛拿到的研究再次重申了這種分布：也就是我們在初期上市假設中所看到的情況、前六週的使用方式，以及我們預期這種情況會如何延續；同時該研究也再次確認了我們先前談到的 20%、30% 佔比——現在既然已獲核准，醫師仍持續表示這確實有可能實現。因此，我們仍然維持樂觀（bullish）並對早期表現感到興奮，但這些趨勢需要時間才能顯現。

And the last thing I'll say on Afrezza is just some of the pharmacies are reporting and some of them are not reporting and so that noise will sort out and we'll continue to keep you updated. We are working through that consistently as Wall Street may try to look at one data source but not have the full data.

關於 Afrezza 我最後想說的是：有些藥局有回報、有些沒有回報，因此那些雜訊會逐步釐清，我們也會持續向各位更新。我們一直在持續處理這件事，因為華爾街可能會試圖只看某一個資料來源，但那並不包含完整數據。

On 201, that's an interesting question in terms of the fastest pathway, having done a lot of biosimilars, my initial goal was to convince the FDA that a biosimilar-like pathway could be appropriate here, meaning a non-inferiority trial with indication extrapolation.

關於 201，就最快的途徑而言這是個有趣的問題；我做過很多生物相似藥（biosimilars），我最初的目標是說服 FDA：這裡可以採用類似生物相似藥的途徑，也就是做一個非劣性（non-inferiority）試驗並進行適應症外推（indication extrapolation）。

I think we need to get the phase two data to show the effect size. To alleviate any concerns that we would be putting this in a large population and not knowing are you switching off stable natetinib to inhaled versus an add-on and so I don't think the FDA has any clear guidance on what they prefer.

我認為我們需要第二期（Phase 2）數據來顯示效果量（effect size）。以消除外界疑慮：我們是否會把它用在大型族群中，卻不清楚你究竟是在把穩定使用 natetinib 的病患改換成吸入式，還是作為加成治療（add-on）；因此我不認為 FDA 對他們偏好的方式有任何明確指引。

But I think what they would like is an add-on design trial with placebo and the good news with the Jascade launch.

但我認為他們會希望看到的是：以安慰劑（placebo）對照的加成設計試驗；而 Jascade 上市的好消息是——

There's clearly going to be more patients to add on top of background therapy, especially as we look at Tyvaso nebulizer. So I'm hopeful as we get to Phase 3, the ability to look at naive patients as well as add on and enroll that trial quickly will happen, and that's our assumption, and then the size of this trial and the primary endpoints will be TBD.

很明顯會有更多病患是在既有背景治療（background therapy）之上再加用，尤其當我們看到 Tyvaso 霧化器（nebulizer）的情況。所以我希望在進入第三期（Phase 3）時，能同時評估未治療（naive）病患以及加成治療，並能快速完成入組；這是我們的假設。至於試驗規模與主要終點（primary endpoints）仍待確定（TBD）。

But that's really what I look at the IPF market as saying. If it was only a tetanib and it had to be an add-on, it would be a hard study to enroll. But given the success of JASCADE and Pirfenidone and Tyvacid nebulizer coming in, I'm excited about the Phase 3 design here.

但這其實就是我對 IPF 市場的看法。如果只有 tetanib，而且必須做加成治療，那會是一個很難入組的研究。但考量到 JASCADE、Pirfenidone 的成功，以及 Tyvacid 霧化器即將進入，我對這裡的第三期設計感到興奮。

Our next question comes from Brandon Folkes from HC Wainwright. Please unmute your line and ask your question.

我們下一個問題來自 HC Wainwright 的 Brandon Folkes。請解除靜音並提出您的問題。

Hi, thanks for taking my question and congrats on all the progress recently.

嗨，謝謝讓我提問，也恭喜你們最近取得的所有進展。

I'll just continue on the Afrezza theme understanding it's very early on. Any color on refills or prescribers writing repeat prescriptions? And then in terms of titration and equivalent dosing, you've generated good data there, but is that.

我會延續 Afrezza 的主題，也理解現在還非常早期。能否談談補領（refills）或開立重複處方（repeat prescriptions）的醫師情況？另外在滴定（titration）與等效劑量（equivalent dosing）方面，你們已產出不錯的數據，但這是否——

Resonating or well-known with the Pete's prescribers right now, or is there a similar learning curve to the adult launch, but this time you're doing it with the data in hand?

目前已在兒科（peds）處方醫師之間產生共鳴或廣為人知？還是說會像成人上市時一樣有類似的學習曲線，只是這次你們手上已有數據？

I think it's too early to get -- we are seeing refills already in month two, so that's a good sign, but it's too early to tell how that builds. I think we're in another month or two of data to really look at those trends in the cash pay and compare it to that QVIA data. But the example, we did see almost a 50% jump in new-to-brand therapy just in June alone. We'll have July very shortly. So that's all positive. In terms of if I think about how many docs wrote three or more scripts, over 30% of our customers have written three or more scripts from what we can see. And that number is probably being conservative because there's some duplication we're trying to eliminate.

我認為現在談還太早——我們在第二個月就已經看到補領，所以這是個好跡象，但現在還太早判斷它會如何累積。我想我們還需要再多一兩個月的數據，才能真正觀察自費（cash pay）的趨勢，並與 QVIA 數據做比較。不過舉例來說，光是在 6 月，我們就看到新使用本品牌治療（new-to-brand therapy）幾乎跳升了 50%。我們很快就會拿到 7 月的數據。所以這些都是正向訊號。至於如果我想想有多少醫師開了三張或以上的處方，從我們能看到的資料來看，超過 30% 的客戶已經開了三張或以上。而這個數字可能偏保守，因為我們正在嘗試排除一些重複（duplication）。

So we do see people already writing a second and third patient.

所以我們確實已看到有人已經在開第二位、第三位病患的處方。

Coming into our referral hub as well as in that QVIA data. So that's another exciting sign that we are seeing the repeat writing happen, let alone the refills. In terms of the learning curve, we tried to apply, as you saw, why do we think this is different from adults? We don't want to make the same perceived objections in adults. And one of the things that came back today, for example, was cost.

不論是在我們的轉介中心（referral hub）或在 QVIA 數據中都是如此。因此，除了補領之外，我們也看到重複開立正在發生，這是另一個令人振奮的訊號。至於學習曲線，我們試著套用——如你所見——為什麼我們認為這次會不同於成人？我們不想重蹈成人市場中那些被認為的反對理由。而今天回饋上來的一點，例如，是成本。

And we're charging $35, yet the perceived cost by the customers is in line with an insulin pump or injectable insulin. So the good news is they're not perceiving cost to be a barrier, which is one of the ones we hear in adults. And the other thing that's coming up is lung safety and lung testing. And so that's another one we want to continue to work through the system and make sure that those are not barriers. If you look at the TOP20 institutions, two of them just wrote this week because it took them seven weeks to figure out how to get the lung function test embedded in their clinical practice.

我們收費是 35 美元，但客戶對成本的感受卻與胰島素幫浦或注射型胰島素相當。所以好消息是，他們不覺得成本是障礙——而這是我們在成人市場常聽到的其中一項。另一個被提到的是肺部安全性與肺功能檢測。因此這也是我們希望持續在體系內推進、確保不會形成障礙的部分。如果你看 TOP20 機構，其中有兩家本週才剛開立，因為他們花了七週才弄清楚如何把肺功能檢測嵌入他們的臨床流程。

But that's done now and that continues to be less of a burden as we go forward.

但現在已經完成了，隨著我們往前推進，這也會越來越不構成負擔。

And the dosing, I think that the change in the label brings people confidence on the conversion because when you're talking about kids or adults and insulin, everyone's told if you dose too much, you go low and you don't do well.

至於劑量，我認為標籤（label）的變更讓大家對換算（conversion）更有信心，因為當你談的是兒童或成人的胰島素時，大家都被告知：如果劑量打太多，就會低血糖（go low），而且結果不會好。

And so that dosing change is bringing people confidence to start with the appropriate dose and titrate out, but most importantly start. And I think that's what that label change has gotten us. And that should result in less dropouts. And again, too early to tell that, but that's one of the things we'll be looking for.

因此，這次的劑量變更讓大家更有信心從適當的起始劑量開始並進行滴定，但最重要的是先開始用藥。我認為這就是這次標籤變更帶給我們的效果。而這應該會帶來更少的中途退出（dropouts）。同樣地，現在還太早下定論，但這是我們會持續觀察的重點之一。

Our next question comes from Yun Zhong from Wedbush. Please unmute your line and ask your question.

我們的下一個問題來自 Wedbush 的 Yun Zhong。請解除靜音並提出您的問題。

Good afternoon.

下午好。

Thank you very much for taking questions and congratulations on the progress. So on the Afrezza pediatric launch, I wanted to ask about, you said one in three of the TOP100 pediatric insulin riders, but what about two? And have they not been reached or are they still trying to figure out maybe whether it's suitable for their patient or have they not received sufficient interest level from their patients? So if there is any additional information that you're able to provide, that would be very helpful. And on the ReadyFlow launch, I know that may not sound like a big deal, but what needs to happen during that three weeks?

非常感謝您接受提問，也恭喜進展順利。關於 Afrezza 的兒科上市，我想問一下，您提到 TOP100 兒科胰島素開立者中有三分之一，但另外三分之二呢？他們是還沒接觸到，還是在評估是否適合他們的病人，或是病人端的興趣不足？如果您能提供任何額外資訊，將會非常有幫助。另外關於 ReadyFlow 的上市，我知道這聽起來可能不是什麼大事，但那三週期間需要完成哪些事情？

That you are not able to launch immediately after the FDA approval?

為什麼無法在 FDA 核准後立刻上市？

Thank you very much.

非常感謝。

Yeah.

是。

I think on the one-third, these are the TOP100 insulin writers. You could imagine it's very hard to get into these places. Many of them are in academic institutions. You have a lot of people taking summer vacations.

我想就三分之一這點而言，這些是 TOP100 的胰島素開立者。你可以想像要打進這些地方非常困難。其中很多在學術機構。而且很多人正在放暑假。

And in some cases, we have in-services scheduled in the month of August and September. So they're not always going to be there in the first 30 days. In many cases, we've been asked to come in ahead of our original in-service date and in service to staff even earlier because of how many patients are coming and asking. So I'd say the other two-thirds, there's probably always going to be 10%, 20% of docs who are never going to write. But the fact is, we're just getting started here in the first eight weeks. I think we're pretty happy with one-third. I think that will continue to close the gap. There's nothing specific that I would sit here and say today, other than time, of why the other two-thirds have not gotten. There's no major objections happening and I think that's what's most important. I've been doing this for 10 years on Afrezza.

有些情況下，我們安排在 8 月和 9 月進行院內教育（in-service）。所以他們不一定會在前 30 天就到位。很多時候，因為有很多病人來詢問，我們被要求在原本的 in-service 日期之前就先進去，甚至更早就對員工做教育訓練。所以我會說，另外三分之二裡面，可能永遠都會有 10%、20% 的醫師不會開立。但事實是，我們才剛開始，這只是前八週。我覺得三分之一的進度我們相當滿意。我認為這個差距會持續縮小。今天我坐在這裡，除了時間之外，沒有什麼特定原因可以說明為什麼另外三分之二還沒跟上。目前沒有出現任何重大反對意見，我覺得這才是最重要的。我做 Afrezza 已經 10 年了。

I go out there with peds and people want to, they're not arguing why they shouldn't use it, they're trying to learn how to use it and that's a very big difference in my experience from adults, they're asking the right questions, I can tell you that I did a dinner in a key part of the country, 15 providers showed up and they held me for three and a half hours of just discussion and that was just their open time. They wanted to stay and continue to understand every nuance of this product over the last 10 years. So that's the level of detail people are getting into in a good way because they want to learn how to write it, how to prescribe it, how to titrate it, and how to really think about using it because it is so different than all the other insulins and so that's the good part about the peds that we're excited about. It's an audience that is more engaged, more open to change, and they are more progressive than the adults and so far we are seeing that.

我到兒科端去，大家想做的不是爭論為什麼不該用，而是在學怎麼用；以我的經驗，這跟成人端差很多。他們問的是對的問題。我可以告訴你，我在全國一個關鍵地區辦了一場晚宴，有 15 位醫療提供者出席，他們光是討論就把我留了三個半小時，那還只是他們的空檔時間。他們想留下來，繼續了解這個產品過去 10 年的每一個細節。所以大家願意深入到這種程度，這是好事，因為他們想學會如何開立、如何處方、如何調整劑量（titrate），以及如何真正思考使用方式，因為它跟其他所有胰島素都非常不同；這也是我們對兒科市場感到興奮的好部分。這是一群更投入、更願意改變、也比成人端更前瞻的受眾，而目前我們確實看到這樣的情況。

On the ReadyFlow, unfortunately or fortunately, depending on what you want to look at, the supply chain is outsourced. Now, the good news is ReadyFlow is in the US versus the on-body infusers outside the US and so that supply chain across the US just takes time to we had to get the labels, we had to get the packaging, we had to get things printed, we got to fit in the queue of the outsource providers and all that's been lined up and the team is working tirelessly day and night to make sure we get there every day we can.

至於 ReadyFlow，不幸或幸運（看你怎麼看），供應鏈是外包的。好消息是 ReadyFlow 在美國境內，而 on-body 輸注器是在美國以外，所以在美國境內的供應鏈就是需要時間：我們得拿到標籤、得做包裝、得把東西印出來、得排進外包供應商的生產排程；這些都已經安排好了，團隊也日以繼夜地努力，確保我們每天都能往目標前進。

But at this point, we've kind of set the target. We're training all the reps next week, the week of August 10th. And the following week, they'll be out there promoting it and inventory should be there by the end of that week or the following Monday. So we'll be shipping drug in the month of August for all intents and purposes and the products made so there's no worries so far that we have around is there manufacturing or anything like that. It's just really the supply chain.

但就目前而言，我們已經訂下目標時程。我們會在下週、也就是 8 月 10 日那週，訓練所有業務代表。接下來一週，他們就會出去推廣，而庫存應該會在那週結束前或隔週一到位。因此就各方面而言，我們會在 8 月出貨藥品；產品也已經製造完成，所以目前我們不擔心製造或類似問題。主要就是供應鏈的問題。

Our next question comes from Anthony Petrone from Mizuho Financial Group. Please unmute your line and ask your question.

我們的下一個問題來自 Mizuho Financial Group 的 Anthony Petrone。請解除靜音並提出您的問題。

Thanks and congrats on the progress this year, one on Afrezza and one on ReadyFlow.

謝謝，也恭喜今年的進展。我有一個關於 Afrezza 的問題，以及一個關於 ReadyFlow 的問題。

I think, Mike, we talked about the additional doses at the upper end of the range for Afrezza, pediatric Afrezza.

我想，Mike，我們談過 Afrezza（兒科 Afrezza）在劑量範圍上端增加更多劑量規格的事。

And maybe when will those be available? And once all of the cartridges are available, what do you think the mix will be?

那些大劑量大概何時會上市？以及當所有藥匣（cartridges）規格都到位後，您認為組合（mix）會是什麼樣子？

In terms of dosing and then how does that translate into gross margin contribution because you have some pricing at the upper end of the range there with the larger dose cartridges and then on ReadyFlow, the transition to SubQ from on-body has a gross margin uplift. I'm just thinking as you go into '27 and we look at product gross margin specifically, when you have that higher mix to ReadyFlow, how should we think about. Product gross margin year over year from 26 to 27? Thanks.

就劑量使用的組合而言，這會如何轉化為毛利貢獻？因為在較大劑量藥匣那端有較高的定價。再來就 ReadyFlow 而言，從 on-body 轉到皮下（SubQ）會帶來毛利率提升。我在想，當我們進入 2027 年、並特別看產品毛利率時，隨著 ReadyFlow 的占比提高，我們應該如何看待2026 到 2027 年產品毛利率的年對年變化？謝謝。

I'll take the first one, I'll punt the second one to Chris.

第一個我來回答，第二個我交給 Chris。

On the Afrezza doses, I would say that work on the high doses will take another 12 to 18 months realistically, and then we got to get that approved.

關於 Afrezza 的大劑量，我會說高劑量的工作實際上還需要再 12 到 18 個月，然後我們還得取得核准。

We have submitted or in the process of submitting that requested FDA to understand and make sure we follow the bracketing approach we're looking for.

我們已經提交，或正在提交我們向 FDA 提出的請求，以了解並確保我們遵循我們希望採用的 bracketting（區間涵蓋）方法。

On the smaller doses, the two-unit, that work has already been done. It's already on stability, and we've already asked FDA about it. So we feel pretty good about getting the smaller dose into the market, hopefully in 2027. And I think that's more important in the short-term as we continue to get the pediatric market going. And even the adult market, I'd say more the type 1 market, they're so used to thinking about half-unit, one-unit increments that a two-unit cartridge really allows them to either start earlier in that Honeymoon period. When they're newly diagnosed, or to titrate between a 4 and an 8 to get to 6 or an 8 and a 12 to get to 10.

至於較小劑量、也就是 2 單位，那部分的工作已經完成。已經進入穩定性（stability）測試，而且我們也已經向 FDA 詢問過。因此我們對於把較小劑量推向市場相當有信心，希望能在 2027 年。我認為短期內這更重要，因為我們會持續推動兒科市場。甚至成人市場也是如此，我會說更偏向第 1 型市場；他們很習慣用半單位、1 單位的增量來思考，因此 2 單位藥匣能讓他們在蜜月期更早開始用藥——也就是剛被診斷時——或是在 4 和 8 之間調到 6，或在 8 和 12 之間調到 10。

There are patients who just want to get that accurate. I don't think it's personally required, but you're changing 100 years of habit, insulin sensitivity ratios, and carb counting and so they've been trained a certain way, and we can either try to retrain all society, or we can try to fit into the model that they're used to and I think the barrier to just fit into the model they're used to is going to make these incremental doses easier.

有些病人就是想要那麼精準。我個人不認為這是必需的，但你是在改變 100 年的習慣、胰島素敏感度比值，以及碳水計算方式；他們一直以某種方式受訓。我們可以試著重新訓練整個社會，或是試著融入他們已經習慣的模式；我認為融入他們習慣的模式這個門檻，會讓這些增量劑量更容易被接受。

I wouldn't expect a lot of change on gross margin between the different doses.

我不預期不同劑量之間的毛利率會有太大變化。

It'll help on the fringes, but I think it's really going to help international. When I look at international markets, cost is a huge barrier. People are paying cash and being able to continue to reduce the cost outside the U.S. Will only increase adoption there, but otherwise you're going to be limited to a very small population until we can get these higher doses into a single cartridge instead of two cartridges because that literally costs them two to three times as much and so that will be a hindrance to global expansion, but in the US, the high doses in Type 2s will be an opportunity to continue to grow as a Type 2 market wants to use of Afrezza as well. So the high doses are important, they're not as important in the next 18 months, but they'll be there.

這會在邊際上有所幫助，但我認為真正會有幫助的是國際市場。當我看國際市場時，成本是一個巨大的障礙。人們是自費付款，而能夠持續降低美國以外的成本，只會提高那邊的採用率；但除此之外，在我們能把這些高劑量做成單一藥匣、而不是兩個藥匣之前，你們將會被限制在非常小的族群，因為那對他們而言字面上就要多花兩到三倍的成本，因此會成為全球擴張的阻礙。不過在美國，第二型糖尿病患者使用高劑量將會是一個持續成長的機會，因為第二型市場也希望使用 Afrezza。所以高劑量很重要，但在接下來 18 個月內沒那麼重要，不過它們會在那裡。

Chris, I'll turn it over to you for the Ready Flow and contribution.

Chris，我把 Ready Flow 和貢獻度的部分交給你。

Yeah, as we think about the Furoscix margin, our commentary has been that the margin increases by about 70% when we think about the transition from OBI to the Ready Flow and so as you start thinking about your model for 2027, you can start thinking about a large majority of that being the Ready Flow and so that will have a significant help for us and the on-body in reality will be impacted by tariffs that are soon coming into play and so that difference between margin would be even exacerbated as we think about future periods.

是的，當我們思考 Furoscix 的毛利率時，我們的說法是：從 OBI 轉換到 Ready Flow 時，毛利率大約提升 70%；因此當你開始思考你對 2027 年的模型時，你可以開始把其中很大一部分視為 Ready Flow，這將對我們有顯著幫助。而實際上，隨身式（on-body）也將受到即將生效的關稅影響，因此當我們思考未來期間時，毛利率之間的差異會更加被放大。

Our final question is coming from Douglas Mean from RBC Capital Markets. Please unmute your line and ask your question.

我們最後一個問題來自 RBC Capital Markets 的 Douglas Mean。請解除靜音並提出您的問題。

My question just has to do with Furosex. And when you look at the first half of the year, the $38 million or so that you reported and achieving the guidance of 110 to 120, it implies around $75 million plus or minus a bit in the second-half of the year, so roughly doubling or so the first half of the year and with the launch occurring later in August, can you just walk us through the cadence and key assumptions that would give you confidence that the guidance range is achievable?

我的問題是關於 Furosex。當你看今年上半年，你們報告大約 3,800 萬美元，並要達成 1.10 億到 1.20 億的指引，這意味著下半年大約需要 7,500 萬美元上下、也就是大致上把上半年的數字翻倍；而且上市是在 8 月較晚的時候才發生，你能否帶我們走一遍節奏（cadence）與關鍵假設，讓你們有信心該指引區間是可達成的？

Thank you, Doug.

謝謝你，Doug。

I'd say a couple of things on this topic. First, if you look at 2025. One-third of the units came in the first half and two-thirds of units came into the second-half of last year. I think that trend is probably what we expect until you start to see either smoothing of Medicare come in more aggressively or there's some way to provide assistance or remove more formularies to preferred status. That patient out-of-pocket cost in the first quarter or two as people close the doughnut hole is a major barrier to that earlier unit adoption.

我想就這個主題說幾點。首先，如果你看 2025 年。有三分之一的出貨量在上半年，三分之二的出貨量在去年下半年。我認為在你開始看到 Medicare 更積極地趨於平滑化，或是有某種方式能提供協助、或把更多處方集（formulary）移到優先（preferred）地位之前，我們大概就會預期這樣的趨勢。在第一季或前兩季，當人們接近並跨越「甜甜圈洞」（doughnut hole）時，病患自付費用是一個阻礙早期採用的主要障礙。

You see the back half of the year as co-pays come down, there's a huge unmet need, patients just can't afford it and that's not thing that MannKind can change, it's not just our product, it's all brands and the co-pay assistance foundations this year went away pretty much with the generics that came in on Entresto, a lot of that assistance that was out there has gone away for these patients and so the fact that we did hit roughly 35% of what we expect for the year in the first half. I think it's great given some of the headwinds that are out there and the patient affordability. So if you just do that, your numbers are roughly directionally accurate of what we expect in the first half and second-half.

你會看到在下半年，隨著自付額（co-pay）下降，存在巨大的未被滿足需求；病患就是負擔不起，而這不是 MannKind 能改變的事情，也不只是我們的產品，是所有品牌都一樣。而今年隨著 Entresto 的學名藥進入市場，協助自付額的基金會幾乎都消失了，許多原本提供給病患的補助都不見了；因此，我們在上半年達到全年預期的大約 35%，考量到外部逆風與病患負擔能力，我認為這很棒。所以如果你照這樣去算，你的數字在方向上大致符合我們對上半年與下半年的預期。

The only thing I'll add to it in terms of can we or can we not achieve that guidance range is the inventory is going to be shifting quite a bit over Q3 and Q4 between the auto-injector and the on-body infuser and so depending on how that conversion and how fast it happens and those inventory buying patterns, that's going to drive a lot of that noise, I'll say, in that range and so things look pretty good, but obviously, the second-half has got a large demand number in front of it and based on history, we expect that we can achieve that demand. But the inventory part will also be another factor here we're driving towards.

我唯一要補充、關於我們能否達成該指引區間的是：在第三季與第四季之間，自動注射器（auto-injector）與隨身式輸注器（on-body infuser）之間的庫存會有相當大的移轉；因此取決於那個轉換如何進行、速度多快，以及那些庫存採購模式，這將驅動我所說的、該區間內很大一部分的雜訊。因此目前看起來相當不錯，但顯然下半年面前有一個很大的需求數字；而根據歷史，我們預期能達成那個需求。但庫存的部分也會是我們推進時的另一個因素。

If there are no further questions, back to Michael Castagna for closing remarks.

如果沒有進一步的問題，交回給 Michael Castagna 做結語。

Thank you, everyone, and great questions. It's somewhat refreshing or concern that we're all talking about Afrezza, but we're really excited about the pediatric launch opportunity we see in front of us. We're happy to hit all three milestones this year. These were amazing hard work on a lot of people and a real big part of the future of the company and I think Furoscix ReadyFlow, we're jazzed what that's going to do for patients and providers and hopefully the launch trajectory there in the second-half really is going to bring a lot of energy and momentum to the company and I want to thank really the patients, the families, our investigators who do all of our trials. We couldn't be here without them and our employees who honestly have worked night and day and weekends to make sure we got through the FDA and got these approval. Now they're preparing for the launches. So a lot of people working a lot of long hours on your behalf and everything we discussed today starts and ends with everyone involved. So thank you to our employees and stakeholders. We look forward to updating you on our progress next quarter. We'll have some we we have three or four investor meetings between now and then. We'll continue to share updates on the launches and how things are progressing at those opportunities. So please dial in and listen and we're always available for questions if you want to reach out.

謝謝大家，也謝謝很棒的問題。我們都在談 Afrezza，這有點令人耳目一新、也有點令人擔心，但我們對眼前看到的小兒上市機會感到非常興奮。我們很高興今年達成全部三個里程碑。這是許多人令人驚嘆的努力成果，也是公司未來非常重要的一部分；而我認為 Furoscix ReadyFlow，我們對它將為病患與醫療提供者帶來的改變感到非常振奮，並希望下半年的上市軌跡真的能為公司帶來大量能量與動能。我也想特別感謝病患、家屬，以及進行我們所有試驗的研究人員。沒有他們，我們不可能走到今天；也感謝我們的員工，他們坦白說日以繼夜、週末也在工作，確保我們順利通過 FDA 並取得這些核准。現在他們正在為上市做準備。所以有很多人為了你們付出長時間的努力，而我們今天討論的一切，都是由所有參與的人開始、也由所有參與的人結束。因此，謝謝我們的員工與利害關係人。我們期待在下個季度向各位更新我們的進展。在那之前我們會有三到四場投資人會議。我們會在那些場合持續分享上市的最新消息，以及進展情況。所以請撥入收聽；如果你想聯繫，我們也隨時可以回答問題。

Thank you, operator. This ends today's call.

謝謝，接線員。今天的電話會議到此結束。

That concludes today's call. You may now disconnect.

今天的電話會議到此結束。您現在可以掛線。