Takeda Pharmaceutical Co Ltd (TAK) 2026 Q1 法說會逐字稿

Earnings announcement ceremony. Language setting to begin with. Please find the language selection button at the bottom of your Zoom window. If you wish to listen in Japanese, please select the Japanese channel. If English, please choose the English Channel. And if you want to listen to the original, please turn it off.

收益公告儀式。首先進行語言設定。請在 Zoom 視窗底部找到語言選擇按鈕。如果您想用日語收聽，請選擇日語頻道。如果是英語，請選擇英語頻道。如果您想聽原版，請將其關閉。

For those of you who wish to listen to this call in English, please select English in the Zoom Language select button.

對於那些希望用英語收聽此通話的人，請在 Zoom 語言選擇按鈕中選擇英語。

And before starting, I'd like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings.

在開始之前，我想提醒大家，我們將討論 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。實際結果可能與今天討論的結果有重大差異。我們最新的 20-F 表格和其他 SEC 文件中討論了可能導致我們的實際結果出現重大差異的因素。

Please also refer to the important notice on Page 2 of our presentation regarding forward-looking statements, our non-IFRS financial measures, which will also be discussed during this call. Definitions of non-IFRS measures and reconciliations with the comparative IFRS financial results are included in the appendix to the presentation.

另請參閱我們簡報第 2 頁上有關前瞻性陳述的重要通知，我們的非國際財務報告準則財務指標也將在本次電話會議上討論。非國際財務報告準則 (IFRS) 指標的定義以及與國際財務報告準則 (IFRS) 財務結果的對照表包含在簡報的附錄中。

Now we'd like to begin. Presentation will be given by Christophe Weber, President and CEO; Milano Furuta, Chief Financial Officer; and Andy Plump, R&D President, and this will be followed by a Q&A session.

現在我們開始吧。總裁兼執行長 Christophe Weber、財務長 Milano Furuta 和研發總裁 Andy Plump 將進行演講，隨後是問答環節。

Let us begin. Christophe, over to you, please.

讓我們開始吧。克里斯托夫，請交給你了。

Thank you, Chris, and thank you, everyone, for joining us today. Our fiscal year 2025 first quarter results reflect the significant impact of VYVANSE's generic erosion on revenue and cooperating profit, which we had anticipated. We actually expect this impact to moderate in future quarters, and fiscal year 2025 will be the last year of significant impact from VYVANSE erosion. There is no change to our outlook for the full year. Milano will discuss our financial results in detail in his presentation.

謝謝克里斯，也謝謝大家今天加入我們。我們的 2025 財年第一季業績反映了 VYVANSE 仿製藥的侵蝕對營收和合作利潤的重大影響，這一點我們已經預料到了。實際上，我們預計這種影響在未來幾季會有所緩和，而 2025 財年將是 VYVANSE 受到侵蝕產生重大影響的最後一年。我們對全年的展望沒有變化。米蘭諾將在演講中詳細討論我們的財務表現。

Fiscal year 2025 is a pivotal year for Takeda, not least because of our rapidly progressing late-stage pipeline. I'm very pleased with our pipeline progress so far and excited about the future. As you know, earlier this month, we announced positive results from 2 pivotal Phase III double-blind placebo-controlled studies of oveporexton. Both studies met all primary and secondary end points at each of the dose we studied. We are very encouraged by this result and what they could mean for people living with narcolepsy type 1.

2025 財年對武田來說是一個關鍵的一年，尤其是因為我們的後期產品線進展迅速。我對我們迄今為止的管道進展感到非常滿意，並對未來充滿期待。如您所知，本月早些時候，我們宣布了 oveporexton 的兩項關鍵 III 期雙盲安慰劑對照研究的積極結果。兩項研究均達到了我們研究的每個劑量的所有主要和次要終點。我們對這一結果感到非常鼓舞，這對患有 1 型嗜睡症的人來說意味著什麼。

Later on this call, Andy will walk you through the top line results and what you can expect next with oveporexton and our orexin franchise as well as other pipeline achievements since Q4.

在本次電話會議的稍後部分，安迪將向您介紹頂線結果以及您對 oveporexton 和我們的 orexin 特許經營權的下一步期望以及自第四季度以來的其他管道成就。

Before we dive deeper into our pipeline strategy, I will pass over to Milano to review our financial results. Milano?

在我們深入探討我們的管道策略之前，我將先讓米蘭諾來審查我們的財務表現。米蘭？

Thank you, Christophe, and hello, everyone. This is Milano Furuta speaking. Let's go to Slide 5, which summarizes our Q1 financial results. As we had anticipated, Q1 is highly likely to be the quarter mostly impacted by loss of exclusivity because of the strong VYVANSE performance in Q1 fiscal year 2024. This created a high comparative baseline for growth rates in Q1, but we expect this to moderate over the rest of the fiscal year.

謝謝你，克里斯托夫，大家好。我是 Milano Furuta。我們來看投影片 5，它總結了我們的第一季財務表現。正如我們預期的那樣，由於 VYVANSE 在 2024 財年第一季的強勁表現，第一季很可能成為受獨家經營權喪失影響最大的季度。這為第一季的成長率建立了較高的比較基線，但我們預計本財年剩餘時間內的成長率將會放緩。

Revenue in Q1 this year was just over JPY1.1 trillion, a decrease of 8.4% or minus 3.7% at constant exchange rates or CER. Core operating profit or OP was JPY321.8 billion, a year-on-year decrease of 15.8% at actual FX or 11.9% at CER. Reported operating profit was JPY184.6 billion, which grew 11%. Core EPS and reported EPS were JPY151 and JPY79, respectively. Cash flow was strong this quarter, with adjusted free cash flow of JPY190.1 billion.

今年第一季的營收略高於 1.1 兆日圓，下降 8.4%，以固定匯率或 CER 計算為 -3.7%。核心營業利潤或 OP 為 3,218 億日元，以實際匯率計算年減 15.8%，以固定匯率計算下降 11.9%。報告營業利潤為1846億日元，成長11%。核心每股盈餘和報告每股盈餘分別為 151 日圓和 79 日圓。本季現金流強勁，調整後自由現金流為 1,901 億日圓。

Slide 6 shows our Growth and Launch Products, which represents 50% of revenue. In Q1, they grew 5% at CER. We see it a little bit slow start, but we anticipated a higher growth rate in subsequent quarters.

幻燈片 6 展示了我們的成長和發布產品，佔收入的 50%。第一季度，其按 CER 計算增長了 5%。我們看到它的起步有點慢，但我們預計接下來的幾個季度的成長率會更高。

In GI, ENTYVIO growth was 4.9% at CER, partially reflecting intensified competition in the IBD market. We do see increasing number of active ENTYVIO PEN patients in the US growing approximately 30% since the last quarter. Awareness, prescription and satisfaction level for ENTYVIO PEN are high, and our focus is to reduce complexity along the reimbursement and authorization pathway. As access for the PEN expands, we expect a higher growth rate for ENTYVIO in the coming quarters.

在 GI，ENTYVIO 成長率以 CER 計算為 4.9%，部分反映了 IBD 市場競爭加劇。我們確實看到美國活躍的 ENTYVIO PEN 患者數量自上個季度以來增長了約 30%。ENTYVIO PEN 的認知度、處方量和滿意度都很高，我們的重點是減少報銷和授權途徑的複雜性。隨著 PEN 存取權限的擴大，我們預計未來幾季 ENTYVIO 的成長率將會更高。

In Rare Diseases, TAKHZYRO continues to grow as a market leader in HAE prophylaxis. In our PDT portfolio, there was some phasing impact in our Q1 results. This is quite commonly PDT, where we often see fluctuations on a quarter-to-quarter basis. We expect both IG and albumin to grow high single digit for the full year.

在罕見疾病領域，TAKHZYRO 持續成長為 HAE 預防領域的市場領導者。在我們的 PDT 產品組合中，第一季的業績受到了一些階段性影響。這是相當常見的太平洋夏令時間 (PDT)，我們經常看到季度間波動。我們預計免疫球蛋白和白蛋白全年都將實現高個位數成長。

In Oncology, FRUZAQLA continues to expand as we roll out global launches. In vaccines, QDENGA was impacted by the timing of product shipments as well as transactional effects, mainly the euro appreciation against the Brazilian real. QDENGA volume is increasing, and we still expect to deliver strong growth for the full year.

在腫瘤學領域，FRUZAQLA 隨著全球產品的推出而不斷擴張。在疫苗方面，QDENGA 受到產品出貨時間以及交易效應的影響，主要是歐元兌巴西雷亞爾升值。QDENGA 的銷售量正在增加，我們仍然預計全年將實現強勁成長。

Slide 7 shows year-on-year revenue performance with a total company. Although our Growth and Launch Products are expanding, we had a significant impact this quarter from VYVANSE generic erosion. Last year, there was a strong rebound in VYVANSE revenue in Q1, mainly due to generic supply constraints in the US and the growth ex US ahead of loss of exclusivity. This resulted in a high year-on-year comparison for Q1 this year.

幻燈片 7 顯示了整個公司的年比收入表現。儘管我們的成長和上市產品正在擴大，但本季我們受到了 VYVANSE 仿製藥侵蝕的重大影響。去年第一季度，VYVANSE 收入出現強勁反彈，主要原因是美國仿製藥供應受限，以及在獨佔權喪失之前美國以外的市場成長。這使得今年第一季的年增幅較高。

We saw the generic supply situation in the US improved from Q2 last year and the generic launches in Canada, Germany and Brazil last summer. This means we expect less headwind from VYVANSE from next quarter onwards.

我們看到美國的仿製藥供應情況較去年第二季有所改善，並且去年夏天加拿大、德國和巴西也推出了仿製藥。這意味著我們預計從下個季度開始 VYVANSE 面臨的阻力會減少。

VYVANSE was the main driver of our revenue decline of 3.7% at CER, in addition to some impact from Medicare Part D redesign. FX was also a headwind this quarter due to appreciation of the Japanese yen against major currencies.

VYVANSE 是我們收入按 CER 計算下降 3.7% 的主要原因，此外還受到 Medicare Part D 重新設計的一些影響。由於日圓兌主要貨幣升值，外匯也成為本季的一大阻力。

Slide 8 shows a year-on-year bridge for core operating profit. You can see that the LOE of high-margin VYVANSE was the main reason for the year-on-year decline of 12% at CER. This was partially offset by operational efficiencies from the enterprise-wide efficiency program we initiated last year, in particular in R&D spend.

幻燈片 8 顯示了核心營業利潤的年比變化。可以看出，高利潤率VYVANSE的LOE是CER年減12%的主要原因。這在一定程度上被我們去年啟動的企業範圍效率計畫帶來的營運效率所抵消，特別是在研發支出方面。

Next, reported operating profit increased by 11% versus prior year, mainly due to lower impairment and restructuring expenses.

其次，報告的營業利潤較上年增長了 11%，這主要歸因於減損和重組費用的降低。

Slide 10 is our latest debt maturity ladder. In June and July this year, we executed 2 leverage-neutral bond issuances, one in Japanese yen and the other in US dollar, to pay off the short-term funding we raised to prepay syndicated loans in March 2025.

投影片 10 是我們最新的債務到期階梯。今年6月和7月，我們發行了兩筆槓桿中性債券，一筆是日元，另一筆是美元，以償還我們為2025年3月預付銀團貸款而籌集的短期資金。

We had to prepay these loans to streamline our upcoming maturity profile in terms of both duration and currency mix. Of note, this new US dollar bonds generated significant demand, more than 4x the USD2.4 billion that we finally issued. This enabled us to secure favorable terms.

我們必須提前償還這些貸款，以簡化我們即將到期的貸款期限和貨幣組合狀況。值得注意的是，本期新發美元債券需求龐大，是最終發行量24億美元需求的4倍多。這使我們能夠獲得有利的條款。

In addition to these refinancings, we also repaid debt that matured in Q1 this year, including an USD800 million bonds. Over the next three years, our average annual maturity is now approximately JPY220 billion, which we believe is manageable considering our cash flow outlook.

除了這些再融資之外，我們還償還了今年第一季到期的債務，其中包括一筆 8 億美元的債券。未來三年，我們的平均年到期金額約為 2,200 億日元，考慮到我們的現金流前景，我們認為這是可控的。

Slide 11 shows our full year outlook for FY '25, which is unchanged since May. As we have explained today, Q1 was significantly impacted by VYVANSE generic erosion, but this was within our expectation, and we are not changing our management guidance.

幻燈片 11 顯示了我們對 25 財年的全年展望，自 5 月以來一直沒有變化。正如我們今天所解釋的那樣，第一季受到 VYVANSE 仿製藥侵蝕的嚴重影響，但這在我們的預期之內，我們不會改變我們的管理指導。

Finally, a word on tariffs. Our FY '25 outlook does not reflect the potential impact of tariffs. And in general, we believe that we are well positioned to manage the potential impact at this time.

最後，談談關稅。我們對 25 財年的展望並未反映關稅的潛在影響。總的來說，我們相信我們目前已做好準備來應對潛在的影響。

This slide is the same as we showed at Q4, and I would like to emphasize again that the value of our imports into the US is approximately 8% to 10% of our US revenue, and the vast majority of this comes from Europe. The tariff rate, let's say 15%, would be applied to this number once it becomes effective.

這張投影片與我們在第四季展示的相同，我想再次強調，我們對美國的進口價值約占我們美國收入的 8% 至 10%，其中絕大部分來自歐洲。一旦生效，關稅稅率（比如說 15%）將適用於這個數字。

Thank you, and I'll now hand over to Andy for updates on the pipeline.

謝謝，現在我將把時間交給安迪，讓他報告管道的最新進展。

Thank you very much, Milano. Hello to everyone on today's call. I'm very excited to begin with the impactful update we have on oveporexton. Narcolepsy type 1 is a neurologic disorder caused by the loss of orexin-producing neurons in the brain. It is characterized by daytime symptoms like excessive daytime sleepiness, cataplexy, cognitive effects such as lack of sustained attention, and nighttime symptoms like sleep paralysis and disrupted nighttime sleep, which all have a substantial impact on patients' ability to function as well as quality of life.

非常感謝，米蘭諾。今天電話會議的各位嘉賓大家好。我很高興首先發布有關 oveporexton 的重大更新。1 型嗜睡症是一種由大腦中產生食慾素的神經元的喪失所引起的神經系統疾病。其特徵是白天症狀，如白天過度嗜睡、猝倒、缺乏持續注意力等認知影響，以及夜間症狀，如睡眠癱瘓和夜間睡眠中斷，這些都會對患者的功能能力和生活品質產生重大影響。

As we communicated earlier this month, both Phase III studies met all primary and all secondary endpoints, demonstrating statistically significant and clinically meaningful improvements at week 12 across all symptoms at both BID doses.

正如我們本月早些時候所傳達的那樣，兩項 III 期研究均達到了所有主要終點和所有次要終點，表明在第 12 週，兩種 BID 劑量的所有症狀均得到了統計學上顯著且具有臨床意義的改善。

These doses were chosen to provide flexibility for physicians and patients to manage daytime and nighttime symptoms. The p-value you see on this slide of less than 0.001 does not do justice to the statistical significance of the trial. Often, results had many more 0s before the 1.

選擇這些劑量是為了讓醫生和患者能夠靈活地控制白天和夜間的症狀。您在此投影片上看到的小於 0.001 的 p 值無法充分反映試驗的統計意義。通常，結果中 1 前面會有很多 0。

Oveporexton is on track to be the first-in-class and potentially best-in-class orexin 2 receptor agonist that treats the underlying orexin deficiency and has the potential to establish a new standard of care in NT1. In 2 Phase III trials, oveporexton demonstrated the ability to normalize the majority of treated patients across almost all NT1 symptoms.

Oveporexton 有望成為同類首創且可能成為最佳的食慾素 2 受體激動劑，用於治療潛在的食慾素缺乏症，並有可能在 NT1 中建立新的治療標準。在 2 項 III 期試驗中，oveporexton 證明能夠使大多數接受治療的患者幾乎所有 NT1 症狀恢復正常。

Improvements in excessive daytime sleepiness were measured using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. MWT is a test used for regulatory purposes, where patients are kept in a dark room and asked to stay awake for 4 40-minute sessions. It is best accompanied with subjective endpoints like the Epworth Sleepiness Scale that describes how well patients respond to treatment. Most of the patients on oveporexton achieved normal ranges for both the MWT and the Epworth Sleepiness Scale.

使用維持覺醒測試和 Epworth 嗜睡量表來測量白天過度嗜睡的改善。MWT 是一種用於監管目的的測試，患者被安置在黑暗的房間裡，並被要求在 4 個 40 分鐘的療程中保持清醒。最好結合主觀終點指標，如描述患者對治療反應如何的 Epworth 嗜睡量表。大多數使用 Oveporexton 的患者的 MWT 和 Epworth 嗜睡量表均達到正常範圍。

Cataplexy is a very important endpoint for patients and regulators. We were thrilled to see that it was so significantly improved across all doses as measured by Weekly Cataplexy Rate questionnaires. Cognitive benefits like sustained attention were recorded using the Psychomotor Vigilance Test.

猝倒對於患者和監管者來說是一個非常重要的終點。我們很高興地看到，根據每週猝倒率問卷的測量，所有劑量的病情都有了顯著改善。使用心理運動警覺測驗記錄了持續注意力等認知益處。

And finally, the benefits to patient satisfaction and quality of life were recorded using surveys like the Short Form-36 that includes measures of fatigue, and measures of holistic function like the Narcolepsy Severity Scale for Clinical Trials that measures the effects on disrupted nighttime sleep, among other symptoms. Nighttime symptoms are also measured subjectively with the use of sleep diaries. Now importantly, all objective measurements were associated with subjective improvements of daily function.

最後，使用包含疲勞測量的簡表 36 等調查來記錄患者滿意度和生活品質的改善，以及整體功能測量，例如臨床試驗發作性睡病嚴重程度量表，用於測量對夜間睡眠中斷等症狀的影響。也可以透過睡眠日記主觀地測量夜間症狀。現在重要的是，所有客觀測量都與日常功能的主觀改善有關。

Oveporexton was generally well tolerated with a safety profile consistent with past studies, no serious treatment-related adverse effects were reported. The most common adverse effects were insomnia, urinary urgency and frequency.

Oveporexton 整體耐受性良好，其安全性與過去的研究一致，沒有報告嚴重的治療相關不良反應。最常見的不良反應是失眠、尿急和頻尿。

As with the Phase IIb experience, the majority of urinary events and insomnia decreased over time in both severity and frequency.

與 IIb 期經驗一樣，大多數尿失禁事件和失眠的嚴重程度和頻率都隨著時間的推移而降低。

More than 95% of participants who completed the study is enrolled in the long-term extension. We believe these data and the high enrollment in the long-term extension study are strong indicators of the transformational benefit oveporexton can deliver across the symptoms that impact NT1 patients. And we look forward to sharing multiple oral presentations starting at World Sleep, with more to follow at future medical conferences.

完成研究的參與者中超過 95% 參加了長期延長研究。我們相信，這些數據和長期擴展研究的高參與率有力地表明了 overporexton 可以為影響 NT1 患者的症狀帶來轉化益處。我們期待在世界睡眠大會上分享多場口頭報告，並在未來的醫學會議上分享更多內容。

Takeda will host an investor call on September 8, 2025, from World Sleep in Singapore. Based on these strong Phase III data, we plan to file for US approval in NT1 later this year, with regional filings to occur simultaneously or shortly thereafter. We believe these outstanding Phase III results have the potential to establish oveporexton as a new standard of care for patients with NT1.

武田將於 2025 年 9 月 8 日在新加坡的 World Sleep 舉辦投資者電話會議。基於這些強勁的 III 期數據，我們計劃在今年稍後申請 NT1 的美國批准，並同時或隨後不久提交地區申請。我們相信，這些出色的 III 期結果有可能使 oveporexton 成為 NT1 患者的新治療標準。

Next slide, please. The Phase III results in NT1 are exciting, and this is just the beginning. We will continue to gather information in the long-term extension to see how patients fare over longer periods of time. As previously reported, sustained effects beyond six months have been observed with many of the patients being treated for more than two years now.

請看下一張投影片。NT1 的第三階段結果令人興奮，而這只是個開始。我們將繼續收集長期擴展訊息，以了解患者在較長時間內的表現。正如先前報導的那樣，許多患者的治療已經持續了兩年多，並且已經觀察到超過六個月的持續效果。

We believe the long-term extension data from the Phase III and Phase IIb trials will enhance our deep understanding of orexin biology, and allow us to optimize treatment for patients in need of this lifetime therapy.

我們相信，III 期和 IIb 期試驗的長期擴展數據將增強我們對食慾素生物學的深入了解，並使我們能夠為需要這種終生治療的患者優化治療。

Our orexin franchise is making rapid progress beyond oveporexton. The next-generation orexin 2 receptor agonist TAK-360 is in Phase II development for narcolepsy type 2 and idiopathic hypersomnia. These results are expected to read out at the end of this fiscal year or early in fiscal year 2026.

我們的 orexin 特許經營權正在超越 oveporexton 取得快速進展。下一代食慾素 2 受體激動劑 TAK-360 正處於治療第 2 型發作性睡病和特發性嗜睡症的 II 期開發階段。預計這些結果將在本財年末或 2026 財年初公佈。

And of course, we continue to work in our laboratories on the discovery and development of additional tailored orexin agonists that have the potential to address vast unmet needs in diseases where orexin plays a role. We expect a new next-generation orexin agonist to enter the clinic later this year as we accelerate development of our multi-asset orexin pipeline.

當然，我們將繼續在實驗室中致力於發現和開發更多客製化的食慾素激動劑，這些激動劑有可能解決食慾素發揮作用的疾病中大量未滿足的需求。隨著我們加速開發多資產食慾素管道，我們預計新的下一代食慾素激動劑將於今年稍後進入臨床。

Next slide, please. Pipeline momentum in fiscal year 2025 is off to a great start. We now have outstanding results from 2 Phase III programs in hand. The Phase III VERIFY study of rusfertide, a first-in-class synthetic hepcidin mimetic in development to treat polycythemia vera was presented at the American Society of Clinical Oncology Plenary session.

請看下一張投影片。2025 財年的管道建設勢​​頭良好。目前，我們已經獲得了兩個第三階段專案的優異成果。在美國臨床腫瘤學會全體會議上介紹了用於治療真性紅血球增多症的首創合成鐵調素類似物 Rusfertide 的 III 期 VERIFY 研究。

The Plenary session is where data with the potential to transform medical practice is typically highlighted. The discussion at the Plenary session, an ASCO appointed expert emphasized that, "The study result is practice-changing," and recommended that rusfertide should become part of the standard of care for patients.

全體會議通常會重點介紹具有改變醫療實踐潛力的數據。在全體會議討論中，ASCO 任命的一位專家強調，“這項研究的結果將改變實踐”，並建議將 Rusfertide 納入患者的標準治療方案。

In our GI squared therapeutic area, we initiated a Phase III head-to-head trial comparing zasocitinib versus deucravacitinib that is designed to clearly differentiate zasocitinib in psoriasis. We also initiated a Phase III trial for elritercept in second-line anemia-associated myelodysplastic syndrome. This is the beginning of a broad late-stage elritercept development program, for which we'll have more to say in the future.

在我們的 GI 平方治療領域，我們啟動了一項 III 期頭對頭試驗，比較扎索替尼與德克拉瓦替尼，旨在明確區分扎索替尼在銀屑病中的療效。我們也啟動了艾利西普治療第二線貧血相關骨髓增生異常症候群的 III 期試驗。這是廣泛的後期 elritercept 開發計劃的開始，我們將來會對此有更多評論。

There are several regional approvals this quarter, including European approval of ADCETRIS as part of an additional chemotherapy regimen in frontline Hodgkin lymphoma. Our plasma-derived therapies continues to broaden indications and enter new markets. HYQVIA was approved in CIDP and multifocal motor neuropathy in Japan. GAMMAGARD ERC, a new formulation with low IgA antibodies, was approved for the US and European markets. In addition, HyHub and HyHub Duo, 2 new devices designed to streamline the administration of HYQVIA, were approved in the US

本季有數個地區獲得批准，包括歐洲批准 ADCETRIS 作為一線霍奇金淋巴瘤的附加化療方案的一部分。我們的血漿衍生療法不斷擴大適應症並進入新的市場。HYQVIA 在日本被批准用於治療 CIDP 和多灶性運動神經病變。GAMMAGARD ERC 是一種低 IgA 抗體的新配方，已獲准在美國和歐洲市場銷售。此外，HyHub 和 HyHub Duo 這兩款旨在簡化 HYQVIA 管理的新設備已在美國獲得批准

Looking forward to the rest of the fiscal year, and if you could move to the next slide, please. 2025 is indeed a pivotal year for our late-stage pipeline. I have already highlighted the next steps for oveporexton. For rusfertide, we are targeting a medical conference in the second half of the fiscal year to share our 52-week data update that will include durability of response and additional safety.

期待本財年的剩餘時間，請轉到下一張投影片。 2025 年確實是我們後期管道的關鍵一年。我已經強調了 oveporexton 的下一步。對於 rusfertide，我們計劃在本財年下半年召開一次醫學會議，分享我們的 52 週資料更新，其中將包括反應的持久性和額外的安全性。

We plan to file an NDA in the US for rusfertide and polycythemia vera in the second half of fiscal year 2025. And finally, later this year, we will have top line data for zasocitinib in 2 pivotal Phase III psoriasis trials, LATITUDE 3001 and 3002.

我們計劃在 2025 財年下半年在美國提交 rusfertide 和真性紅血球增多症的 NDA。最後，今年晚些時候，我們將在兩項關鍵的 III 期牛皮癬試驗 LATITUDE 3001 和 3002 中獲得 zasocitinib 的頂線數據。

Looking further into the future, next slide, please. The 6 programs in our late-stage pipeline have the potential to deliver transformative benefits to patients while contributing to Takeda's long-term growth. Zasocitinib, our oral allosteric TYK2 inhibitor, continues to add expansion opportunities, and we'll start a Phase II study in hidradenitis suppurativa, or HS, within the next year.

展望未來，請看下一張幻燈片。我們後期研發管線中的 6 個項目有可能為患者帶來變革性益處，同時促進武田的長期成長。我們的口服變構 TYK2 抑制劑 Zasocitinib 繼續增加擴展機會，我們將在明年內啟動化膿性汗腺炎 (HS) 的 II 期研究。

HS is a chronic, recurrent and debilitating inflammatory skin condition. The global prevalence is estimated to be around 2%. There are limited approved treatment options available, and people living with HS continued to experience high disease burden. We believe there is a significant need for a durable and effective advanced systemic therapy.

HS 是一種慢性、復發性且使人衰弱的發炎性皮膚病。全球盛行率估計約2%。目前核准的治療方案有限，HS 患者持續承受著沉重的疾病負擔。我們相信，我們非常需要一種持久有效的先進全身性治療方法。

Going forward, we will maintain our strong focus on late-stage development activities with a continued emphasis where possible on acceleration. These efforts will support our ambition to file up to 5 additional indications from our late-stage programs through fiscal year 2029.

展望未來，我們將繼續高度關注後期開發活動，並盡可能繼續強調加速。這些努力將支持我們實現到 2029 財年從我們的後期專案中提交最多 5 個額外適應症的目標。

Thank you very much, and I'll now turn it back to Chris for Q&A.

非常感謝，現在我將把時間交還給克里斯進行問答。

(Interpreted) Now I'd like to open the floor for your questions. And we have Christophe, Milano, Andy and US Business Unit President, Julie Kim as well to answer your questions. (Operator Instructions)

（口譯）現在我想開始回答大家的提問。我們還有 Christophe、Milano、Andy 和美國業務部門總裁 Julie Kim 來回答您的問題。（操作員指示）

First question, Morgan Stanley, Muraoka-san.

第一個問題，摩根士丹利，Muraoka 先生。

Unmute yourself and ask a question.

取消靜音並提出問題。

(Interpreted)This is About the sales of individual products looking at that Evio, IG, Kenga, they were relatively weak.

(翻譯)這是關於單一產品的銷售情況，從Evio、IG、Kenga來看，它們相對較弱。

And I think your message was that they're okay. But in the 2nd quarter for those 4 products that I just mentioned, do you expect Recovery?

我認為你的意思是他們沒事。但是對於我剛才提到的四種產品，您預計第二季會復甦嗎？

That's my first question. And the second question is After 861 and 360, I think you have another molecule coming into the pipeline. So what is the additional benefit and what kind? What advantage can we expect for this new molecule that be added to the pipeline.

這是我的第一個問題。第二個問題是，繼 861 和 360 之後，我認為還有另一個分子進入管道。那麼額外的福利是什麼以及是什麼樣的呢？我們可以期待這種新分子加入管道中會帶來什麼好處？

(Interpreted) First question was about IG, ENTYVIO, VYVANSE, and what was the fourth one?

（譯）第一個問題是關於 IG、ENTYVIO、VYVANSE，第四個問題是什麼？

QDENGA.

QDENGA。

QDENGA. Okay, thank you. So the first question, about some of the products that were a little bit weaker in Q1, so IG, ENTYVIO, VYVANSE, QDENGA in particular. How are these looking to perform in the rest of the year? Perhaps I'll ask Christophe to begin that answer and then Julie to add detail as required.

QDENGA。好的，謝謝。第一個問題是關於第一季表現稍弱的一些產品，特別是 IG、ENTYVIO、VYVANSE 和 QDENGA。這些產品在今年剩餘時間內的表現如何？也許我會請克里斯托夫開始回答這個問題，然後朱莉會根據需要添加細節。

And then the second question was for any additional data that we can -- or any additional direction we can provide on the next additional orexin agonist coming through into the pipeline later this year. I'd like to ask Andy to comment on that, please.

第二個問題是，我們可以提供任何額外的數據，或者關於今年稍後即將推出的下一種食慾素激動劑的任何額外指導。我想請安迪對此作出評論。

Thank you, Chris. It's very clear that in our mind, the first quarter is quite soft and does not reflect the underlying dynamics of our product. And this is why we have not changed our guidance for the year. We believe that this first quarter does not reflect the dynamic of the product.

謝謝你，克里斯。很明顯，在我們看來，第一季的表現相當疲軟，並沒有反映出我們產品的潛在動力。這就是我們沒有改變今年指導方針的原因。我們認為第一季的數據並未反映出產品的動態。

So in the case of ENTYVIO, the PEN continues to accelerate. We are not at full market access yet in the US So that means that we are losing some prescription and therefore, some switch opportunity from IV to subcu, but we are progressing in terms of market access and will reach the maximum and the optimal stage during that -- this year. So that we continue to accelerate the PEN and the feedback we are getting on the PEN is very strong. Julie can explain further.

因此，就 ENTYVIO 而言，PEN 繼續加速。我們尚未完全進入美國市場，這意味著我們正在失去一些處方，因此，也失去了一些從靜脈注射到皮下注射的轉換機會，但我們在市場准入方面正在取得進展，並將在今年達到最大和最佳階段。因此，我們將繼續加速 PEN 的進程，我們收到的有關 PEN 的回饋非常強烈。朱莉可以進一步解釋。

On VYVANSE, Milano has explained that Q1 is extremely impactful in terms of growth rate because of a year-on-year comparison. We also know that eventually, there will be -- we'll reach a plateau. Therefore that's why we believe that this year is the last year of significant impact of VYVANSE generic exposure. So you will see a waning impact during the year, especially because there was a very significant generic penetration at the end of last year.

對於 VYVANSE，米蘭諾解釋說，由於與去年同期相比，第一季的成長率極具影響力。我們也知道，最終我們會達到一個穩定狀態。因此，我們認為今年是 VYVANSE 仿製藥曝光產生重大影響的最後一年。因此，你會看到，今年的影響會逐漸減弱，特別是因為去年年底仿製藥的滲透率非常高。

The immunoglobulins, there is always some quarter-by-quarter growth rate change, but we remain committed to the forecast that we gave in Q4, which is mid-single-digit overall PDT franchise growth, high single digit for IG. So you see we are slightly lower. I mean remember that when it comes to immunoglobulin, the demand is greater than supply. So it's all about allocation, and we have a very competitive portfolio right now with new indication.

免疫球蛋白的季度成長率總是會有一些變化，但我們仍然堅持我們在第四季度給出的預測，即整體 PDT 特許經營成長率為中等個位數，IG 成長率為高個位數。所以你看我們稍微低一點。我的意思是，請記住，當涉及免疫球蛋白時，需求大於供應。所以一切都與分配有關，我們現在擁有非常有競爭力的投資組合和新的跡象。

And QDENGA is actually the same. The demand is greater than supply. We are ramping up our supply. So it's all about shipment and allocating our doors to where we have greater demand. So we are very much convinced that QDENGA will continue to grow in the future. And this is why, overall, we believe that we will deliver our guidance, which is broadly flat in revenue, for example, for the year.

而QDENGA其實也是一樣的。需求大於供給。我們正在增加供應。所以一切都與運輸有關，並將我們的門分配到需求量較大的地方。因此我們非常有信心QDENGA未來將繼續發展。這就是為什麼我們總體上相信我們將實現我們的預期，例如全年收入基本上持平。

Muraoka-san, this is Andy. Maybe I can dial up and provide some context regarding our approach to orexin and our broader orexin franchise. So we think of diseases that could potentially be managed through orexin agonism in three buckets.

村岡先生，這是安迪。也許我可以撥打電話並提供一些有關我們對食慾素和更廣泛的食慾素特許經營權的方法的背景資訊。因此，我們認為可以透過食慾素激動劑來治療的疾病有三類。

There's orexin deficiency, which is NT1. There are other rare diseases that are characterized by normal orexin levels, like NT1 and idiopathic hypersomnia. And then there's a large array of more common diseases that have symptoms like disruptions in sleep-wake cycles like other neuropsychiatric symptoms that we believe modulation of the orexin pathway could be beneficial. And it's clear that TAK-861 is not just a first-in-class for type 1 narcolepsy, but a potential best-in-class and with potentially very little room for additional differentiation.

存在食慾素缺乏症，即 NT1。還有其他罕見疾病的特徵是食慾素水平正常，如 NT1 和特發性嗜睡症。還有大量較常見的疾病，其症狀包括睡眠-覺醒週期紊亂以及其他神經精神症狀，我們認為調節食慾素路徑可能有益。很明顯，TAK-861 不僅是治療第 1 型嗜睡症的首創藥物，而且可能是同類最佳藥物，幾乎沒有進一步分化的空間。

For TAK-360, as I've mentioned, we're still learning a lot about TAK-360, and we have 2 ongoing Phase IIb programs in type 2 narcolepsy and idiopathic hypersomnia. So rare diseases that are characterized by orexin deficiency.

對於 TAK-360，正如我所提到的，我們仍在學習很多有關 TAK-360 的知識，並且我們有兩個正在進行的 IIb 期項目，分別針對 2 型發作性睡病和特發性嗜睡症。因此，罕見疾病的特徵是食慾素缺乏。

We'll have another molecule coming into the clinic later this year, and we continue to build additional molecules that have differentiated pharmacology that we can use to begin to explore benefits in more common disorders. The way I would think about orexin is that with 861, we're really just scratching the tip of the iceberg.

今年晚些時候，我們將有另一種分子進入臨床，我們將繼續建構具有差異化藥理學的更多分子，我們可以使用這些分子開始探索更常見疾病的益處。我對食慾素的看法是，有了 861，我們實際上才觸及了冰山一角。

The product that is different in pharmacology is that for more general disease, more common diseases. Is that the correct understanding?

藥理上不同的產品是針對較普遍的疾病，較常見的疾病。這是正確的理解嗎？

That's our intent at this point. I mean, we have to also recognize that there's still an immense amount to learn about this pathway after type 1 narcolepsy. So we have the level of experience that we have in type 1 narcolepsy with these Phase III results and with the extension from our Phase IIb study, where we have patients now up to -- have been on therapy for up to two years is quite extensive.

這就是我們目前的意圖。我的意思是，我們還必須認識到，關於 1 型嗜睡症後的這條途徑，仍有大量知識需要學習。因此，根據這些 III 期研究結果以及 IIb 期研究的延伸，我們在第 1 型嗜睡症治療方面擁有豐富的經驗，目前我們的患者已經接受治療長達兩年，治療時間相當廣泛。

There's still very little known about this pathway outside of type 1 narcolepsy. Our intent is to win and own this pathway with multiple molecules and explore the best potential of this disease in both rare and common disorders.

除了 1 型嗜睡症之外，人們對這種途徑的了解仍然很少。我們的目的是贏得並擁有這種具有多種分子的途徑，並探索這種疾病在罕見和常見疾病中的最佳潛力。

(Interpreted) Next question is Yamaguchi-san from Citi, please.

（翻譯）下一個問題是花旗銀行的山口先生。

Can you hear me?

你聽得到我嗎？

Yes, we hear you.

是的，我們聽到了。

This is Yamaguchi from Citigroup. I have two questions. The first question, regarding the competitive landscape of narcolepsy. Recently, Alkermes put up a top line release on the orexin, and they seem to be missing cataplexy portion of the data. And you talk about -- Andy-san was talking about cataplexy portion. So can you -- you don't need to talk about completion, but can you elaborate how this is important and how this is going to be differentiated from your products and Alkermes products? That's the first question.

我是花旗集團的山口。我有兩個問題。第一個問題，關於嗜睡症的競爭格局。最近，Alkermes 發布了關於食慾素的頂線新聞稿，但他們似乎缺少猝倒症部分的數據。您說的是——安迪先生正在談論猝倒症部分。那麼您可以——您不需要談論完成度，但您可以詳細說明這有多重要以及這與您的產品和 Alkermes 產品有何區別嗎？這是第一個問題。

Second question is more broad questions. Christophe-san was talking about some general investment strategy for the US, which does not really contain new things, but it was like $30 billion in total. Globally speaking, a global major company like your company is trying to put up some investment to the US market for the future, especially on the manufacturing side.

第二個問題是更廣泛的問題。Christophe-san 談到了美國的一些整體投資策略，其中實際上並沒有包含新內容，但總額約為 300 億美元。從全球來看，像貴公司這樣的全球性大公司正在試圖對美國市場進行一些未來投資，特別是在製造業方面。

Do you have any kind of new plan how to accelerate those investments in the US? Or can you make any kind of comment on what's the new sort of business model that US companies, including your companies, are looking for in the US like DTC, trying to control the cost structure. So that's an open question, the second one.

您有什麼新計劃來加速在美國的投資嗎？或者您能否評論美國公司（包括貴公司）在美國尋求的新型商業模式，例如 DTC，試圖控製成本結構。所以這是一個懸而未決的問題，第二個問題。

Thank you, Yamaguchi-san. So the first question on our thoughts on evolving data in the narcolepsy landscape. I'd like to ask Andy to comment on that. And then the second question on investment in the US or how our business may evolve given the changing landscape in the US I'd like to ask Christophe to comment on that, please.

謝謝你，山口先生。因此，第一個問題是我們對發作性睡病領域不斷發展的數據的看法。我想請安迪對此作出評論。第二個問題是關於在美國投資，或考慮到美國情勢的變化，我們的業務將如何發展，我想請克里斯托夫對此發表評論。

Thanks, Chris, and thanks for the question, Yamaguchi-san. So as I mentioned, we believe that TAK-861 oveporexton is not just first-in-class but potentially best-in-class agent. We've seen benefits across all symptoms using both objective and subjective measures. And in many cases, these benefits normalize these patients across all many or some of the symptoms of narcolepsy type 1, including cataplexy.

謝謝克里斯，也謝謝山口先生的提問。正如我所提到的，我們相信 TAK-861 oveporexton 不僅是同類首創藥物，而且可能是同類最佳藥物。我們透過客觀和主觀的測量方法看到了所有症狀的益處。在許多情況下，這些益處可使患者的所有或部分 1 型嗜睡症症狀（包括猝倒症）恢復正常。

So cataplexy is a somewhat variable measurement. We were very pleased to see that our results in cataplexy are quite significant and very meaningful for patients, and we look forward to presenting those data at World Sleep next month.

因此猝倒症是一種有一定變異性的測量方法。我們非常高興地看到，我們在猝倒症方面的成果對患者來說非常重要且非常有意義，我們期待下個月在世界睡眠大會上展示這些數據。

It's hard to comment on the competitive landscape because we haven't seen data. So we'll see data rolling out in Sleep. But I think suffice it to say, we really believe, with the time advantage that we have and with the data that we'll present next month, that oveporexton is a highly competitive agent in this class.

由於我們還沒有看到數據，因此很難評論競爭格局。因此我們將看到睡眠中的數據。但我想可以說，我們真的相信，憑藉我們擁有的時間優勢和下個月將提供的數據，oveporexton 是這一類別中極具競爭力的代理商。

Thank you, Andy and Yamaguchi-san. Regarding our investment first, I would like to remind everyone that we are highly invested in the US So for example, if you look at our manufacturing network, the country where we have the biggest manufacturing presence in terms of number of sites and number of products we manufacture, number of colleagues that are involved, is by far the US So that's why we are extremely balanced and we will continue to invest in this manufacturing network in the US And that's also why we -- our exposure to tariff is limited, as Milano explained.

謝謝你，安迪和山口先生。首先關於我們的投資，我想提醒大家，我們在美國投入了大量資金。例如，如果你看看我們的製造網絡，就工廠數量、生產的產品數量、參與的同事數量而言，我們擁有最大製造業務的國家是美國。這就是為什麼我們非常平衡，我們將繼續在美國投資這個製造網絡。這也是為什麼我們——我們對關稅的影響有限，正如米蘭諾所解釋的那樣。

So strategically, we continue to take into consideration many parameters when we decide a new investment. Of course, we are very much aware of geopolitical consideration and other considerations. So that will drive our investment decision in the future.

因此，從策略上講，我們在決定新投資時會繼續考慮許多參數。當然，我們非常清楚地緣政治考量和其他方面的考量。這將推動我們未來的投資決策。

But I want to really reinforce the fact that we are extremely invested in the US on the manufacturing side, obviously, also on the R&D side. We do the majority of our research and development activities in the US So -- and that, we think, is important for our long-term strategy and strategic situation because we also do the majority of our revenue, the biggest part of our revenue in the US.

但我想強調的是，我們在美國製造業方面投入了大量資金，顯然在研發方面也投入了大量資金。我們的研發活動大多在美國進行，因此，我們認為這對我們的長期策略和策略狀況很重要，因為我們大部分的收入，也就是最大一部分收入也來自美國。

When it comes to the DTC, I will ask Julie to comment on the direct-to-consumer model. If Julie, could you give your perspective about that, that would be great.

當談到 DTC 時，我會請朱莉對直接面向消費者的模式發表評論。朱莉，您能否就此發表您的看法，那就太好了。

Yes. Thank you, Christophe. In terms of the direct-to-consumer model that you've heard about in the news, this is an opportunity for the pharmaceutical companies to be able to offer their medicines on a platform, cutting out the middleman in the US.

是的。謝謝你，克里斯托夫。就您在新聞中聽到的直接面向消費者的模式而言，這對製藥公司來說是一個機會，他們可以在一個平台上提供藥品，從而繞過美國的中間商。

So this would allow us to go direct as the platform indicates. And this would provide lower pricing directly to patients without necessarily impacting the pharmaceutical companies negatively because as you're probably aware, on average across the industry, roughly 50 cents of the dollar goes to other players in the value chain. So the manufacturers currently receive, on average, 50 cents on the dollar. So being able to offer a significant discount on the list price through these platforms does give patients a direct benefit, and it's also good from the manufacturer standpoint as well.

這樣我們就可以依照平台指示直接行動。這將直接為患者提供更低的價格，而不必對製藥公司產生負面影響，因為您可能知道，在整個行業中，平均約有 50 美分流向了價值鏈中的其他參與者。因此，製造商目前平均每美元可獲得 50 美分的收益。因此，能夠透過這些平台提供大幅的標價折扣確實能為患者帶來直接利益，而且從製造商的角度來看也是一件好事。

Julie, can you comment? Still just to manage expectations, our portfolio of product does not -- is not an easy one to apply DTC. Can you comment on that?

朱莉，你能評論一下嗎？仍然只是為了管理預期，我們的產品組合並不容易應用 DTC。您能對此發表評論嗎？

Sure. The key aspect of the DTC platforms that I should have mentioned is that this is cash paying for the patients. And so this is primarily more retail medicines. The current products like insulin are offered in this type of platform as well as GLP-1, for example. So our portfolio is not necessarily this type of retail medicine, but we will look at opportunities for products such as TRINTELLIX on this platform.

當然。我應該提到的 DTC 平台的關鍵方面是，這是為患者支付的現金。所以這主要是更多的零售藥品。例如，目前的胰島素等產品以及 GLP-1 都是在這種平台上提供的。因此，我們的產品組合不一定是這種類型的零售藥品，但我們會在這個平台上尋找 TRINTELLIX 等產品的機會。

Thank you, Yamaguchi-san. Moving to the next question then. Next question, I'd like to call on Stephen Barker from Jefferies, please.

謝謝你，山口先生。那麼轉到下一個問題。下一個問題，請 Jefferies 的 Stephen Barker 回答。

Yes. Steve Barker from Jefferies. My first question is related to spending. You are forecasting full year SG&A flat year-on-year and a small increase in R&D, but both SG&A and R&D were both down substantially in the quarter. So I was wondering if you could comment on that and the outlook for spending?

是的。傑富瑞的史蒂夫·巴克。我的第一個問題與支出有關。您預測全年銷售、一般及行政費用將與去年同期持平，研發費用將小幅增加，但本季銷售、一般及行政費用及研發費用均大幅下降。所以我想知道您是否可以對此以及支出前景發表評論？

And then the second question is related to orexin. As per the slide, you are looking for the new compound, which is scheduled to enter development this year. You're looking at indications like sleep-wake, respiration, metabolism. Sleep-wake, I think that's something related with Alzheimer's respiration. Should we be thinking sleep-wake is Alzheimer's respiration, sleep apnea perhaps, and then metabolism. Is that something -- if you could comment on how orexin might affect metabolism and if it could actually be useful in treating obesity. I'd like a comment on that, too, please.

第二個問題與食慾素有關。根據幻燈片，您正在尋找新的化合物，該化合物計劃於今年投入開發。您正在觀察睡眠-覺醒、呼吸、新陳代謝等指標。睡眠-覺醒，我認為這與阿茲海默症的呼吸有關。我們是否應該認為睡眠-覺醒是阿茲海默症的呼吸，也許是睡眠呼吸暫停，然後是新陳代謝。這是什麼——如果您能評論一下食慾素如何影響新陳代謝以及它是否真的有助於治療肥胖症。我也想對此發表評論。

Thank you, Steve, for your questions. So the first question on trends of spending Q1 versus the full year outlook. I'd like to ask Milano to comment on that? And the second, on the new compounds in orexin, looking at sleep-wake disorders, what potential exists in these areas, particularly obesity is an area of interest. I'd like to ask Andy to comment on that, please.

謝謝史蒂夫的提問。因此，第一季度是關於第一季支出趨勢與全年前景的比較。我想請米蘭諾對此作出評論？第二，關於食慾素中的新化合物，研究睡眠-覺醒障礙，這些領域有什麼潛力，特別是肥胖是一個令人感興趣的領域。我想請安迪對此作出評論。

Steve, thank you for the question. So let me answer to the -- about SG&A first. So this is -- mostly this decline compared to year-on-year in the last quarter 1 is for SG&A, it's more like FX. If you compare the constant exchange rate, it should be mostly flat. That's SG&A. So it's in line with the full year forecast.

史蒂夫，謝謝你的提問。因此，讓我先回答有關銷售、一般和行政費用 (SG&A) 的問題。因此，與上一季相比，這種下降主要是因為銷售、一般和行政費用 (SG&A)，更像是外匯。如果比較恆定匯率，它應該基本上持平。這就是銷售、一般及行政費用 (SG&A)。因此這與全年預測一致。

For R&D, we do the invest for the pipeline development. And still, we anticipate the R&D investment is ramping up. For example, now we start head-to-head study with deucra in July. Elritercept, also in July, we started the trial. For 360, also we started the trial in April. So we are ramping up our activities.

對於研發，我們對管道開發進行投資。我們預計研發投資仍將持續增加。例如，現在我們在 7 月開始與 deucra 進行正面交鋒的研究。Elritercept，也是在 7 月份，我們開始了試驗。對於 360，我們也在四月開始了試用。因此我們正在加大活動力度。

But still the good thing is that we also see the savings from the efficiency program we initiated last year. And then we are also keeping the very tight management of the headcount, the cost to both sides. So that we see also the benefit from all the savings efforts. So that's how the Q1 the numbers, they eventually, they landed. But eventually, we are still keeping the full year forecast management guidance for both SG&A and R&D.

但好消息是，我們也看到了去年啟動的效率計畫所帶來的節省。然後，我們也對員工人數和雙方的成本進行嚴格管理。這樣，我們也看到了所有節約努力所帶來的好處。這就是第一季的數據最終得出的結果。但最終，我們仍將保留銷售、一般及行政費用和研發費用的全年預測管理指引。

Stephen, on your question regarding the breadth of potential of orexin agonists across indications. I'll go back to the earlier comment that we're really just starting to scratch the surface of the potential of this biology. We know now definitively that agonism of the orexin 2 receptor in type 1 narcolepsy can have profound benefits and be administered in a way that's tolerable for patients.

史蒂芬，關於你提出的關於食慾素激動劑在不同適應症中的潛力範圍的問題。我回到先前的評論，我們實際上才剛開始觸及這種生物學潛力的表面。我們現在確切地知道，激動食慾素 2 受體可以為 1 型嗜睡症帶來顯著的益處，並且可以以患者可以忍受的方式進行治療。

So now we're starting to imagine and develop molecules that have an array of pharmacology that will allow us to explore opportunities in other rare disorders like type two narcolepsy, like idiopathic hypersomnia, and then begin to explore opportunities in other disorders that are characterized by either sleep-wake cycle disruption because there's an obvious link there.

因此，現在我們開始設想和開發具有一系列藥理學功能的分子，這將使我們能夠探索治療其他罕見疾病的機會，例如二型嗜睡症、特發性嗜睡症，然後開始探索治療以睡眠-覺醒週期紊亂為特徵的其他疾病的機會，因為這兩者之間存在明顯的聯繫。

Respiration, we've already shown and we've published with TAK-925, our IV molecule, that there are unique properties of this pathway in respiration. And based on extensive scientific literature and the expression patterns of the orexin receptors in the hypothalamus, we believe that there are potential opportunities in metabolism.

呼吸，我們已經證明並且已經透過我們的 IV 分子 TAK-925 發表了這項研究成果，證明這種呼吸途徑具有獨特的特性。並且基於大量的科學文獻和下丘腦中食慾素受體的表達模式，我們相信在代謝方面存在潛在的機會。

I don't want to get too far out ahead of ourselves. Our goal is to develop the array of molecules that will allow us to explore this breadth of indications and to go from there.

我不想走太遠。我們的目標是開發一系列分子，使我們能夠探索廣泛的適應症並從那裡開始。

Thank you, Steve. Moving on to the next question. I'd like to call on TD Cowen, Michael Nedelcovych.

謝謝你，史蒂夫。繼續下一個問題。我想請 TD Cowen 的 Michael Nedelcovych 發言。

I have two. My first is on ENTYVIO. You've noted in the past that transitioning patients from Part B to Part D coverage has been a hurdle to adoption of the PEN. Why should we expect that dynamic to fall away in the coming quarters?

我有兩個。我的第一個是在 ENTYVIO 上。您過去曾指出，將患者從 B 部分保險過渡到 D 部分保險一直是採用 PEN 的障礙。為什麼我們預期這種動態會在未來幾季消失？

And on the same topic, a competitor, IL-23, will likely soon offer subcutaneous induction and maintenance. How do you think that might change the competitive landscape, especially considering that the ENTYVIO PEN seems to be helping to ward off competition. So that's my first question on ENTYVIO.

在同一主題上，競爭對手 IL-23 可能很快就會提供皮下誘導和維持治療。您認為這可能會如何改變競爭格局，尤其是考慮到 ENTYVIO PEN 似乎有助於抵禦競爭。這是我對 ENTYVIO 的第一個問題。

And then my second question is on zasocitinib. In the head-to-head trial versus deucravacitinib, can you remind us if it's powered for superiority? And in that trial, if zasocitinib only shows non-inferiority, how would that affect your $3 billion to $6 billion peak sales ambition in psoriasis?

我的第二個問題是關於扎索替尼的。在與 deucravacitinib 的頭對頭試驗中，您能否提醒我們它是否具有優越性？在該試驗中，如果扎索替尼僅表現出非劣效性，這將如何影響您在牛皮癬領域實現 30 億至 60 億美元的高峰銷售目標？

Thank you, Michael. So the first question on ENTYVIO coverage and competition landscape, I'd like to ask Julie to comment on that. And the second question on the head-to-head, is it powered for superiority? Andy, if you could take that one, please.

謝謝你，麥可。因此，關於 ENTYVIO 覆蓋範圍和競爭格局的第一個問題，我想請朱莉對此發表評論。關於正面交鋒的第二個問題是，它是否擁有優勢？安迪，請你接受這個。

Michael, thank you for the question. When you look at the dynamics in the US around PEN access, you are right, there have been challenges in terms of making the switch. But we're working through the quality, I'll call it, the quality of the access at the local level. Sometimes, this is a challenge of the coverage that's provided at the parent plan, not being pulled all the way through to the local plan. Sometimes it's because of that switch from IV to PEN, medical to pharmacy. Sometimes, it's a system issue and helping, again, at the very local level, addressing those specific system issues.

邁克爾，謝謝你的提問。當您觀察美國在 PEN 訪問方面的動態時，您是對的，在轉換方面確實存在挑戰。但我們正在努力提高質量，我稱之為地方層面的訪問質量。有時，這是母公司計劃提供的保險範圍的挑戰，而不是完全延伸到本地計劃。有時這是因為從靜脈注射到筆式註射、從醫療到藥局的轉換。有時，這是一個系統問題，需要再次在本地層面提供協助，解決這些特定的系統問題。

So we're attacking all of these one by one. And as we clear through them, we are seeing the pull-through on PEN. So this is why we believe that as we continue to improve the overall coverage level and that quality of the pull-through that we'll see the benefit from PEN driving further growth as we're seeing roughly 30% growth quarter-over-quarter on the PEN.

因此，我們正在逐一解決這些問題。當我們清除它們時，我們看到了 PEN 的拉通。因此，我們相信，隨著我們繼續提高整體覆蓋水平和拉動質量，我們將看到 PEN 帶來的好處推動進一步增長，因為我們看到 PEN 的季度環比增長約為 30%。

In terms of the second part of your question in regards to subcu induction, that is something that we are also looking at. And for right now, ENTYVIO still has very strong bio-naive starts within UC in particular. And so this is something that, as we continue again to pull through on the access, we expect to see further growth for the PEN.

關於您問題的第二部分，即皮下誘導，這也是我們正在研究的內容。就目前而言，ENTYVIO 在 UC 領域仍然擁有非常強大的生物基礎。因此，隨著我們繼續努力提高進入門檻，我們預計 PEN 將進一步成長。

And Michael, I'll start on zaso and then hand it over to Christophe to talk about the competitive dynamic. So we're seeing great progress in our overall zaso program. As I mentioned, on track to read out our 2 psoriasis Phase III studies later this year. Our psoriatic arthritis program is going well, 2 Phase IIb studies in UC and Crohn's that will read out next year, starting now in HS. And then we have an additional indication and perhaps indications that we look forward to starting soon.

邁克爾，我將先從 zaso 開始，然後交給克里斯托夫來談談競爭動態。因此，我們看到整個 zaso 計劃取得了巨大進展。正如我所提到的，我們將在今年稍後讀出我們的兩項牛皮癬 III 期研究成果。我們的乾癬性關節炎計畫進展順利，潰瘍性結腸炎和克隆氏症的 2 個 IIb 期研究將於明年完成，現在已在 HS 開始。然後我們還有一個額外的跡象，也許還有跡象表明我們期待很快開始。

Your question specifically on the head-to-head with deucravacitinib, yes, this study is powered for superiority. And Christophe, I'll hand it back to you.

您的問題具體是關於與 deucravacitinib 的正面交鋒，是的，這項研究是為了證明優越性而進行的。克里斯托夫，我會把它交還給你。

Thank you, Andy, and thank you, Mike, for the question. Yes, it's a head-to-head superiority because we are very confident, obviously, that the product profile will deliver this type of result. It is important because we want to demonstrate that zasocitinib is a new class of oral, which changed the efficacy profile of the oral treatment.

謝謝安迪和麥克提出的問題。是的，這是一種面對面的優勢，因為我們顯然非常有信心，產品配置將帶來這種結果。這很重要，因為我們想證明扎索替尼是一種新型口服藥物，它改變了口服治療的療效。

Today, the oral treatment have around 16% market share, and it has not been growing. And we believe that our compound zasocitinib, perhaps also with another compound or another class in development in oral. You know what I'm talking about, we'll change that. And we believe that's the promise of this new oral is to really change the importance or the contribution of oral treatment to the treatment of psoriasis. So this head-to-head is important to really create a new oral standard in terms of efficacy. But of course, we will also use the Phase III result. Thank you.

如今，口服治療藥物的市佔率約為16%，且沒有成長。我們相信，我們的化合物扎索替尼或許還可以與另一種化合物或另一類口服藥物一起開發。你知道我在說什麼，我們會改變這一點。我們相信這種新型口服藥物的前景是真正改變口服治療對牛皮癬治療的重要性或貢獻。因此，這種面對面的比較對於真正創建新的口服療效標準非常重要。但當然，我們也會使用第三階段的結果。謝謝。

(Interpreted) Let me go to the next question, Nomura Securities, Matsubara-san.

(翻譯)我來回答下一個問題，野村證券的松原先生。

(Interpreted) This is Matsubara, Nomura Securities. Can you hear me okay?

(翻譯) 我是野村證券的松原。你聽見我說話嗎？

(Interpreted) Yes, we can hear you.

（翻譯）是的，我們能聽到您的聲音。

(Interpreted) My first question is related to an earlier comment. First quarter growth, first quarter numbers doesn't necessarily represent the overall growth dynamic. But if you look at the sales in the US, it looks quite weak. So I want to understand why. That's my first question.

（譯）我的第一個問題與先前的評論有關。第一季的成長，第一季的數字不一定代表整體的成長動態。但如果你看看美國的銷售情況，你會發現它相當疲軟。所以我想了解原因。這是我的第一個問題。

And the second question is about TAKHZYRO. Again, TAKHZYRO is weak in the United States. What is the reason behind this? And also Ionis' donidalorsen is going to be launched very soon. So this is going to be a competition for new patients. So should we have some concern for this product in the future?

第二個問題是關於TAKHZYRO的。再次，TAKHZYRO在美國表現疲軟。這背後的原因是什麼？而 Ionis 的 donidalorsen 也即將推出。所以這將是一場爭奪新病人的競賽。那麼，我們以後是否該對這款產品有所擔憂呢？

Thank you, Matsubara-san. So the first question on the US revenue performance in Q1 and what some of the dynamics there are? And then the second question on TAKHZYRO specifically. So I'd like to ask Julie to comment on those, please.

謝謝你，松原先生。那麼第一個問題是關於第一季美國營收表現以及有哪些動態？然後第二個問題具體是關於TAKHZYRO的。所以我想請朱莉對此發表評論。

Thank you, Matsubara-san, for the question. One of the things that please remember in terms of the US performance is that you're also seeing reflected in these numbers, the impact of the Medicare Part D redesign across key products in our portfolio. So that is part of the impact on the growth.

謝謝松原先生提出的問題。就美國的表現而言，請記住的一件事是，您還從這些數字中看到了醫療保險 D 部分重新設計對我們產品組合中關鍵產品的影響。這是對成長的部分影響。

In regards to TAKHZYRO in particular, TAKHZYRO continues to have strong performance in the US And yes, there are new competitors coming on to the market. But in terms of efficacy, there is really not a significant change in efficacy from those competitor products. When you look at the long-term history that we have, both in terms of performance and safety, and you look at the real-world data that we've collected on TAKHZYRO since its launch, we are in a very strong position to defend TAKHZYRO in HAE.

特別是就 TAKHZYRO 而言，TAKHZYRO 在美國持續表現強勁，而且，市場上正在出現新的競爭對手。但從功效上來說，與競品相比，功效確實沒有太大的變化。當您回顧我們在性能和安全性方面的長期歷史，並查看自 TAKHZYRO 推出以來收集的真實世界數據時，我們會發現我們在 HAE 中完全有能力捍衛 TAKHZYRO。

(Interpreted) This is Furuta speaking, I would like to add just one comment. In the United States, Christophe and Julie has already mentioned the product dynamics and also we don't -- I don't have any additional thing to say about the overall situation. But everything that we've experienced so far is US focused, including VYVANSE. VYVANSE's impact is the biggest in the US And this is why the US numbers and performance looks a little bit softer.

（翻譯）我是 Furuta，我只想補充一點評論。在美國，克里斯托夫和朱莉已經提到了產品動態，而且我們也沒有——對於整體情況，我沒有什麼可說的。但迄今為止我們所經歷的一切都是以美國為中心的，包括 VYVANSE。VYVANSE 在美國的影響最大，這也是為什麼美國的數據和表現看起來稍微疲軟的原因。

As far as TAKHZYRO is concerned, demand continues to be strong, but the channel inventory is now lower. That's another factor behind the weak performance of TAKHZYRO.

就TAKHZYRO而言，需求持續強勁，但通路庫存目前較低。這是TAKHZYRO業績不佳的另一個因素。

(Interpreted) Next question is Wakao-san, JPMorgan, please.

(口譯) 下一個問題是摩根大通的 Wakao 先生。

JPMorgan, Wakao. I have two questions. Firstly, about R&D expense. R&D expense represent only 90% progress toward the full year guidance, which seems to be slow. Is this in line with the plan or there are any suppression for spending? And based on the first quarter progress, do you foresee any change to your full year R&D expense outlook, with the 861 oveporexton Phase II now completed, also does not seem to be a fact that to drive an increase in this fiscal year. This is the first question.

摩根大通，若尾。我有兩個問題。第一，關於研發費用。研發費用僅佔全年預期進度的 90%，似乎進展緩慢。這是否符合計劃或是否有任何支出抑制？並且根據第一季的進展，您是否預見到全年研發費用前景會有任何變化，因為 861 overporexton 第二階段現已完成，這似乎也不會成為推動本財年增長的事實。這是第一個問題。

And the second question is about MFN. You briefly mentioned the US policy, but I'd like to know more about Most Favored Nation drug pricing policy. Are you currently in discussion with the US government on MFN? And have you received any indication of targeting drug pricing? That's it.

第二個問題是關於最惠國待遇。您簡單提到了美國的政策，但我想了解更多關於最惠國藥品定價政策的資訊。你們目前正在與美國政府討論最惠國待遇問題嗎？您是否收到過針對藥品定價的任何跡象？就是這樣。

Thank you, Wakao-san. So the first question on R&D expense progress towards the full year guidance. Is this in line with plan? Milano can comment on that. And then the second question on discussions around Most Favored Nation, I'd like to ask Julie to comment on that, please.

謝謝你，若尾先生。因此，第一個問題是關於研發費用是否達到全年預期。這符合計畫嗎？米蘭諾可以對此發表評論。然後關於最惠國討論的第二個問題，我想請朱莉對此發表評論。

Thank you, Wakao-san. So I'm going to comment on the first R&D spend in Q1. So if you compare against last year Q1, there is a multiple effect. So I think to Steve's question previously, I explained in -- as a kind of efficiency program as a whole. But there's a detailed explanation I can add. So the -- compared to last year, we had some -- a few program termination, like soticlestat or 062. So these program termination create some space for the budget. That's one.

謝謝你，若尾先生。因此，我將對第一季的首筆研發支出發表評論。因此，如果與去年第一季進行比較，就會發現多重影響。所以我認為對於史蒂夫之前提出的問題，我解釋過——作為一種整體的效率計劃。但我可以添加一個詳細的解釋。因此，與去年相比，我們有一些專案終止，例如 soticlestat 或 062。因此這些項目的終止為預算創造了一些空間。那是一個。

The second, we had some pipeline financing arrangement with Blackstone. That also helps for the R&D savings.

第二，我們與黑石集團達成了一些管線融資安排。這也有助於節省研發成本。

And the third one is something I mentioned previously that we are continuing for the efficiency program efforts. So we managed the overall, the budget, everything is very tight. So that's also creating the savings space.

第三個是我之前提到的，我們正在繼續努力提高效率。因此，我們對整體情況、預算等一切都管理得非常嚴格。這也創造了儲蓄空間。

So if you recall our explanation of the Q4, we are making all these savings, and then we will reinvest for those savings for the pipeline development. That's going to happen. So from July, we are starting the Phase III for the elritercept, head-to-head study with the deucra. So this will ramp up, and then we will increase. We will ramp up all these R&D operations. So eventually, all in all, we are in line with the plan.

因此，如果您還記得我們對第四季度的解釋，我們正在進行所有這些節省，然後我們將把這些節省的資金再投資於管道開發。那將會發生。因此，從 7 月開始，我們將啟動 elritercept 與 deucra 的正面交鋒研究的第三階段。因此，這個數字將會上升，然後我們會增加。我們將加強所有這些研發工作。所以最終，總的來說，我們是按照計劃進行的。

So could you clarify first quarter performance? Was in line with your internal plan or below?

那麼您能澄清一下第一季的表現嗎？是否符合您的內部計劃或低於該計劃？

Yes. We are making savings. But overall, we are in line with the plan.

是的。我們正在儲蓄。但總體來說，我們是按照計劃進行的。

And thank you, Wakao-san. In terms of MFN discussions in the US, so there have been numerous different statements about MFN, both from the President as well as others in the administration at a high level. So details have not really been shared yet at this point. We have not been contacted directly in terms of price and negotiations at this point. We are gearing up and preparing for the potential negotiation of ENTYVIO as part of the IRA Medicare price negotiations.

謝謝你，若尾先生。就美國的最惠國待遇討論而言，總統和政府其他高層人士都對最惠國待遇發表了許多不同的聲明。因此目前我們尚未真正分享細節。目前我們還沒有就價格和談判問題直接聯繫過。我們正在為 ENTYVIO 作為 IRA 醫療保險價格談判的一部分的潛在談判做好準備。

Now MFN in general, there are a basket of countries that are being considered, we think. And we are assessing what the potential impact of that could be depending on a variety of different scenarios for how MFN can be applied. So we're working on our own mitigation plans for that, and we're preparing, as I said, for the price negotiations as part of the IRA Medicare price negotiations. That is a place where the MFN type of approach could be applied, but we're waiting to see further details.

目前，就最惠國待遇而言，我們認為，有許多國家正在考慮中。我們正在根據最惠國待遇適用的各種不同情況來評估其可能產生的潛在影響。因此，我們正在製定自己的緩解計劃，正如我所說，我們正在為 IRA 醫療保險價格談判的一部分的價格談判做準備。這是一個可以應用最惠國待遇類型方法的地方，但我們正在等待進一步的細節。

(Interpreted) Due to time limitation, the next question will be the last question, which is from Ueda-san from Goldman Sachs.

（翻譯）由於時間限制，下一個問題是最後一個問題，來自高盛的 Ueda 先生。

(Interpreted) Yes, this is Ueda, Goldman Sachs. I want to ask a question about the preparation for the launch of oveporexton. First-in-class and best-in-class potentials were mentioned today. But what about the sales team? And what are the preparations underway for the launch of oveporexton? Because you're focusing on NT -- narcolepsy type 1, I think diagnostics is very important. Last year, in R&D Day, you talked about use of digital technology potentially. So I want to understand how this technology is being prepared, leading up to the launch.

（翻譯）是的，我是高盛的 Ueda。我想問一個關於oveporexton發布準備工作的問題。今天提到了同類第一和同類最佳的潛力。但銷售團隊怎麼樣？那麼，oveporexton 的上市準備工作正在進行中嗎？因為您關注的是 NT——1 型嗜睡症，所以我認為診斷非常重要。去年，在研發日，您談到了數位科技的潛在用途。所以我想了解這項技術在發布前的準備。

Thank you for the question, Ueda-san. So a question on how we are preparing for the launch of oveporexton. What are the approaches we're taking, including use of digital, et cetera. So I'd like to call upon Julie to answer that question, please.

謝謝上田先生的提問。問題是我們如何為 oveporexton 的推出做準備。我們採取了哪些方法，包括使用數位化技術等等。因此我想請朱莉來回答這個問題。

Yes. Thank you for the question, Ueda-san. As you can imagine, we are very excited to be preparing for the potential launch of oveporexton for narcolepsy type 1 patients. So we are gearing up in terms of our commercial structure and organization as well as our medical team, which is already out in the field educating on oveporexton in narcolepsy type 1.

是的。謝謝上田先生的提問。你可以想像，我們非常高興能夠為 1 型嗜睡症患者推出 Oveporexton 做好準備。因此，我們正在加強商業結構和組織以及醫療團隊的建設，我們的醫療團隊已經在實地開展關於 1 型嗜睡症患者使用 Oveporexton 的培訓。

In terms of the digital support for oveporexton, we are looking at a number of different avenues and approaches to support, particularly diagnosis in narcolepsy type 1. This is an area where we are looking to unlock the bottleneck that exists in terms of diagnosis through sleep centers. So we will share more detail once we're able to do so. But this is quite an exciting opportunity for us. And as I said, we're looking at multiple digital avenues to support diagnosis and the overall patient experience.

在 oveporexton 的數位支援方面，我們正在尋找多種不同的途徑和方法來提供支持，特別是對 1 型嗜睡症的診斷。我們正在尋求解決這一領域中存在的透過睡眠中心進行診斷的瓶頸。因此，一旦我們能夠這樣做，我們就會分享更多細節。但這對我們來說是一個非常令人興奮的機會。正如我所說，我們正在尋找多種數位途徑來支持診斷和整體患者體驗。

(Interpreted) Thank you. Additional comment from Furuta-san.

（翻譯）謝謝。Furuta-san 的補充評論。

(Interpreted) Yes, Mr. Wakao. Q1 R&D spend, I just wanted to add some comment because there may have been some inaccuracies in what I said earlier. Q1, we had savings. And your question was whether this is according to our internal plan. And I have to say that the savings actually was bigger than what we had planned for. But R&D delivery implementation is according to plan. So saving is not impairing the delivery of R&D. And we are really enjoying the benefit of the efficiency programs in the past, which means that it's possible that savings may be a little bit higher than we have planned.

（翻譯）是的，若尾先生。Q1 研發支出，我只是想補充一些評論，因為我之前說的可能有些不準確。Q1，我們有儲蓄。您的問題是這是否符合我們的內部計劃。我必須說，節省的金額實際上比我們計劃的要多。但研發交付實施正按計畫進行。因此，儲蓄不會損害研發的發展。我們確實享受了過去效率計劃帶來的好處，這意味著節省的金額可能比我們計劃的要高一些。

(Interpreted) Thank you very much. With that, we would like to conclude today's webinar. We would like to thank you all again for being a part of this program despite a very busy schedule, and we appreciate your kind, continued support.

（翻譯）非常感謝。今天的網路研討會就此結束。我們想再次感謝大家在非常繁忙的日程中參與這個項目，我們感謝你們的友好和持續的支持。

Portions of this transcript that are marked (interpreted) were spoken by an interpreter present on the live call. The interpreter was provided by the company sponsoring this event.

本記錄中標記（翻譯）的部分是由現場通話中的翻譯人員說的。翻譯由贊助此活動的公司提供。