MannKind Corporation (MNKD) 2026 Q1 法說會逐字稿

Good afternoon, and welcome to the MannKind Corporation first quarter 2026 financial results earning call. As a reminder, this call is being recorded on May 5, 2026, and will be available for replay on the MannKind Corporation website shortly after this call for approximately 90 days.

下午好，歡迎參加 MannKind Corporation 2026 年第一季財務業績電話會議。提醒各位，本次電話會議於 2026 年 5 月 5 日錄音，並將於會後不久在 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. For further information on the company's risk factors, please see the Form 10-K for the period ended March 31, 2026, the earnings release, and the slides prepared for this presentation.

本次電話會議將包含前瞻性陳述。此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。有關公司風險因素的更多資訊，請參閱截至 2026 年 3 月 31 日期間的 Form 10-K、新聞稿（earnings release）以及為本次簡報準備的投影片。

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

今天與會的 MannKind 代表包括執行長 Michael Castagna 先生，以及財務長 Chris Prentiss 先生。現在我想把會議交給 Castagna 先生。先生，請開始。

Thanks, operator. Good afternoon, everyone. Thank you for joining us for our Q1 2026 earnings call. Here's today's agenda, and I'll start with some opening remarks. In the first quarter, we continue to execute our strategy to evolve MannKind to a diversified company positioned to deliver sustained long-term growth. The company is fundamentally different than it was even a few years ago, and we are excited about the near-term milestones that will further advance the company's evolution.

謝謝，接線員。各位下午好。感謝各位參加我們 2026 年第一季財報電話會議。以下是今天的議程，我將先做一些開場說明。在第一季，我們持續執行策略，推動 MannKind 轉型為多元化公司，以實現可持續的長期成長。公司與幾年前相比已根本不同，我們也對近期里程碑感到振奮，這些里程碑將進一步推動公司的演進。

Today, we will discuss the recent positive developments with United Therapeutics and articulate our growth plans that we expect will drive significant shareholder value over the coming years. Let's begin with our announcement earlier today that MannKind 1501 has been unveiled as Ralinepag DPI, which United Therapeutics optioned into back in August last year.

今天我們將討論與 United Therapeutics 近期的正面進展，並闡述我們的成長計畫；我們預期這些計畫將在未來幾年為股東創造顯著價值。首先，讓我們從今天稍早的公告開始：MannKind 1501 已正式揭露為 Ralinepag DPI，而 United Therapeutics 早在去年 8 月即已行使選擇權納入該項目。

Our formulation team has been moving Ralinepag DPI forward expeditiously. And we recently received a $5 million payment to prioritize the continued rapid advancement of this program. We have the potential to receive up to $35 million in developed milestones plus a 10% royalty on net sales. Of those milestones, we expect about $15 million to be earned over the next 12 months.

我們的製劑團隊正迅速推進 Ralinepag DPI。我們近期也收到 500 萬美元款項，用以優先支持該計畫持續快速推進。我們有機會獲得最高 3,500 萬美元的開發里程碑款，另可就淨銷售額收取 10% 權利金。在這些里程碑款中，我們預期未來 12 個月內約可認列 1,500 萬美元。

This expanded collaboration is significant for a few reasons. First, it deepens an already productive partnership with United Therapeutics. Second, the Ralinepag DPI is the potential to be used across pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis, and progressive pulmonary fibrosis, collectively impacting more than 250,000 patients and representing a substantial opportunity to improve the outcomes across these conditions.

此次擴大合作在幾個方面具有重大意義。第一，它深化了我們與 United Therapeutics 既有且富有成效的合作夥伴關係。第二，Ralinepag DPI 具有潛力可用於肺動脈高壓、與間質性肺病相關的肺高壓、特發性肺纖維化，以及進行性肺纖維化；合計影響超過 25 萬名患者，並代表一個可大幅改善這些疾病治療結果的重大機會。

Third, it continues to validate our unique Technosphere platform. In addition to Ralinepag DPI, we've also confirmed MannKind is a sole manufacturer to base with DPI under a supply agreement that includes contractual minimums. This provides us with a solid foundation as we continue to scale our Danbury, Connecticut facility for our own pipeline, including a manufacturing build-out to support the growth of Furoscix ReadyFlow.

第三，它持續驗證我們獨特的 Technosphere 平台。除 Ralinepag DPI 外，我們也已確認 MannKind 依據一項包含合約最低量承諾的供應協議，將成為 DPI 的唯一製造商。這為我們持續擴充位於康乃狄克州丹伯里（Danbury）的廠房奠定穩固基礎，以支援我們自有產品線；其中包括擴建製造產能，以支援 Furoscix ReadyFlow 的成長。

Now, let's move on to Q1 performance. We delivered quarterly revenues of $90 million, a 15% increase over the prior year as this now includes the addition of Furoscix. Q1 was a challenging quarter for several reasons. Number one is structural. We see each year as Q1 typically declines relative to Q4 due to annual deductible resets. As patients face higher out-of-pocket costs at the start of the year, we see both fewer fills and lower doses per prescription. For Furoscix, doses per prescription were down roughly 20% in Q1 compared to Q4.

接下來談第一季表現。我們實現季度營收 9,000 萬美元，較去年同期成長 15%，其中已包含 Furoscix 的併入貢獻。第一季因多項原因而具挑戰性。第一是結構性因素。我們每年都觀察到第一季通常會較第四季下滑，原因在於年度自付額（deductible）重置。由於患者在年初面臨較高的自付費用，我們看到處方領藥次數減少，且每張處方的劑量也較低。就 Furoscix 而言，第一季每張處方的劑量較第四季約下降 20%。

Number two is transitional. As we prepared for our upcoming launches of Afrezza Pediatrics and the Furoscix ReadyFlow Autoinjector, we reorganized the field teams, leading to customer disruptions in Q1 as we didn't want to disrupt the field in Q4 or the upcoming next two quarters given the potential launches.

第二是過渡性因素。在我們為即將推出的 Afrezza 兒科適應症與 Furoscix ReadyFlow 自動注射器上市做準備時，我們重整了外勤團隊；由於我們不希望在第四季或接下來兩季（考量可能的上市）打亂前線，因此第一季出現了一些客戶端的干擾。

Additionally, we reallocated marketing resources away from Afrezza adult, which slowed the growth year-over-year as we thought it would be more prudent to shift these investments towards the pediatric Afrezza launch and Furoscix nephrology opportunity. We have made the adjustments and the field teams in place today are talented, highly experienced in their therapeutic areas, and have the right resources to deliver quarterly growth the balance of the year.

此外，我們將行銷資源自 Afrezza 成人市場重新配置，導致年對年成長放緩；我們認為將這些投資轉向 Afrezza 兒科上市以及 Furoscix 的腎臟科（nephrology）機會會更為審慎。我們已完成調整，目前的外勤團隊具備才能、在各自治療領域擁有高度經驗，並擁有適當資源，可在今年剩餘期間帶動季度成長。

Number three, as we prepare for the launch in Q3 of the autoinjector, we want to ensure an efficient conversion. We transitioned our inventory levels to minimize volatility and inventory stocking of the current on-body infusor at the specialty pharmacies. As this adjustment is now behind us, we expect future product outflows to better reflect underlying prescriber demand, which will help us accelerate the transition upon FDA approval.

第三，隨著我們為第三季自動注射器上市做準備，我們希望確保轉換效率。我們調整了庫存水位，以降低波動，並減少專科藥局對現行貼附式輸注器（on-body infusor）的庫存備貨。由於此項調整已告一段落，我們預期未來產品出貨將更能反映處方需求的基本面，並在 FDA 核准後協助我們加速轉換。

So when you put these three things together, Q1 came in lighter on the revenue side, but even so, the underlying indicators were more encouraging than the top-line quarter may suggest. We saw growth in both overall writers and repeat writers of Furoscix, hitting a record number of prescribers in Q1, and demand momentum improved as the quarter progressed. Doses dispensed are up nearly 60% through April compared to the same period last year.

因此，綜合這三項因素，第一季在營收端較為偏弱；但即便如此，基本面指標其實比表面營收所呈現的情況更令人鼓舞。我們看到 Furoscix 的整體開立醫師數與重複開立醫師數皆成長，第一季開立醫師數創下新高，且需求動能在季度進行中持續改善。截至 4 月，已配發劑量（doses dispensed）較去年同期成長近 60%。

Chris will walk through the quarter in more detail. But we are confident the underlying business is moving in the right direction, and we remain on track to meet our full-year 2026 Furoscix revenue target of $110 million to $120 million.

Chris 將更詳細說明本季表現。不過，我們對業務基本面朝正確方向發展充滿信心，並仍按計畫達成 2026 全年 Furoscix 營收目標 1.10 億至 1.20 億美元。

Now let's walk through the Q1 highlights. The FDA approved the updated Afrezza label, which now provides clear starting dose guidance. That's an important enabler for the pediatric launch, as this was the dosing used for the pivotal trial.

接著我們回顧第一季重點。FDA 已核准更新後的 Afrezza 標籤，現已提供清楚的起始劑量指引。這是推動兒科上市的重要助力，因為這正是關鍵性試驗（pivotal trial）所採用的劑量設定。

We've also completed our launch buildout for Afrezza Pediatrics ahead of the May 29 PDUFA date. We completed the pilot phase enrollment in our INHALE-1ST pediatric trial, evaluating Afrezza in youth with newly diagnosed Type 1 diabetes. That's the long-term goal I've talked about for years.

我們也已在 5 月 29 日 PDUFA 日期之前完成 Afrezza 兒科上市的建置工作。我們已完成 INHALE-1ST 兒科試驗的試點階段（pilot phase）受試者招募，該試驗評估 Afrezza 用於新診斷第一型糖尿病的青少年。這就是我多年來一直談到的長期目標。

Additionally, we settled the convertible notes, which strengthens the balance sheet. And finally, on the scPharma integration, we are now approximately seven months post-close. Now, I'm very pleased with how the integration has progressed. For most functions, integration is substantially complete. And we've identified synergies that exceeded our $20 million annual target we previously set.

此外，我們已清償可轉換公司債（convertible notes），進一步強化資產負債表。最後，關於 scPharma 的整合，我們在交割完成後目前約七個月。我對整合進展非常滿意。就多數職能而言，整合已大致完成。而且我們所辨識的綜效已超過先前設定的每年 2,000 萬美元目標。

I want to thank both teams for the way they came together. These integrations are always challenging, and ours is going exceptionally well. I now take a step back to talk about a strategic evolution because this slide tells a really important story. Until 2022, we were essentially a single product company with Afrezza.

我要感謝兩個團隊以如此方式攜手合作。這類整合一向充滿挑戰，而我們的整合進行得格外順利。現在我退一步談談策略演進，因為這張投影片講述了一個非常重要的故事。在 2022 年之前，我們基本上是一家以 Afrezza 為單一產品的公司。

Since then, United Therapeutics and Tyvaso DPI specifically has played a critical role in funding our transformation, including enabling scPharma (technical difficulty)

自那之後，United Therapeutics，尤其是 Tyvaso DPI，在資助我們的轉型方面扮演了關鍵角色，其中包括促成 scPharma（技術問題）