Takeda Pharmaceutical Co Ltd (TAK) 2024 Q1 法說會逐字稿

[Interpreted] Thank you very much for joining us today despite a very busy schedule for this FY '23 Q1 earnings announcement. My name is O'Reilly, I am the Head of IR. I'll be the master of ceremony for today's meeting. (Operator Instructions) Before starting, I'd like to remind everyone that we will 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. Please also refer to the important notice on the Page 2 of the presentation regarding forward-looking statements and our non-IFRS financial measures, which will also be discussed during this call. Definitions of our non-IFRS measures and reconciliations with comparable IFRS financial measures are included in the appendix in the presentation. Please also note the important notice is on the Page 2 of the presentation material.

[解讀] 非常感謝您今天加入我們，儘管本次 23 財年第一季度收益公告的日程非常繁忙。我叫 O'Reilly，是 IR 主管。我將擔任今天會議的司儀。 （操作員說明） 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》含義內的前瞻性陳述。實際結果可能與今天討論的結果存在重大差異。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。另請參閱演示文稿第 2 頁上有關前瞻性陳述和我們的非國際財務報告準則財務措施的重要通知，這些信息也將在本次電話會議中進行討論。我們的非國際財務報告準則衡量標準的定義以及與可比國際財務報告準則財務衡量標準的調節表包含在演示文稿的附錄中。另請注意，重要通知位於演示材料的第 2 頁上。

Now we would like to start the presentation. Today, we have President and CEO, Christophe Weber; R&D President, Andy Plump; Chief Financial Officer, Costa Saroukos presenting to you. This will be followed by Q&A session. Now we would like to begin. Christophe, please go ahead.

現在我們要開始演示。今天，我們的總裁兼首席執行官 Christophe Weber；研發總裁 Andy Plump；首席財務官 Costa Saroukos 向您介紹。隨後將進行問答環節。現在我們想開始。克里斯托夫，請繼續。

Thank you, Chris. Thank you, everyone, for joining us today. It's a pleasure to be with you all. Our performance in the first quarter of this fiscal year again underscores the strength of our business and our ability to continue to deliver life-transforming treatments to patients and communities over the long term.

謝謝你，克里斯。謝謝大家今天加入我們。很高興和大家在一起。我們在本財年第一季度的業績再次凸顯了我們的業務實力以及我們繼續長期為患者和社區提供改變生活的治療方法的能力。

Looking at our financial results. In the first 3 months of fiscal year 2023, revenue was JPY 1.06 trillion. Year-over-year growth at a constant exchange rate was plus 3.7%, driven by momentum in our growth and launch products, which represent 40% of total revenue and grew in this first quarter at 16.2%. At actual exchange rates, our top line growth was 8.9%. Our top line performance contributed to core operating profit of JPY 326.3 billion. The year-over-year decline at constant exchange rates reflect the impact of loss of exclusivity and lower coronavirus vaccine demand as well as our strategic investment in R&D and data and technology to ensure Takeda long-term competitiveness.

看看我們的財務業績。 2023財年的前3個月，收入為1.06萬億日元。按固定匯率計算，同比增長 3.7%，這得益於我們的增長和推出產品的勢頭，這些產品佔總收入的 40%，第一季度增長了 16.2%。按實際匯率計算，我們的收入增長率為 8.9%。我們的營收業績為核心營業利潤貢獻了 3,263 億日元。按固定匯率計算的同比下降反映了獨家經營權喪失和冠狀病毒疫苗需求下降的影響，以及我們為確保武田長期競爭力而對研發、數據和技術進行的戰略投資。

Core EPS for the period was JPY 150, flat versus prior year at a constant exchange rate. On a reported basis, EPS declined due to the impact of onetime financial income gains in the first quarter of last year. Our results at constant exchange rates are tracking well against our full year management guidance for fiscal year '23, and there is no change to our guidance at this time.

該期間核心每股收益為 150 日元，按固定匯率計算與上年持平。從報告來看，由於去年第一季度一次性財務收入增長的影響，每股收益下降。我們按固定匯率計算的業績與我們 23 財年的全年管理指引保持良好一致，目前我們的指引沒有變化。

Moving to the right of the slide, we are advancing our innovative pipeline to reach new patient population, address unmet needs and provide new treatment options to improve patient outcome and quality of life. Our dengue vaccine, QDENGA, was recently approved in Argentina and Thailand, and we are pleased with the momentum we are seeing in both endemic and travel market. I will discuss QDENGA further on the next slide. In other regulatory development, we have filed GAMMAGARD LIQUID in the U.S. for the treatment of chronic inflammatory demyelinating polyneuropathy, or CIDP. This follows on from the submission of HYQVIA for CIDP in Q4 of last year, representing near-term indication expansion opportunities for 2 of the growth and launch products in our PDT Immunology portfolio.

轉到幻燈片右側，我們正在推進我們的創新管道，以接觸新的患者群體，解決未滿足的需求並提供新的治療方案，以改善患者的治療結果和生活質量。我們的登革熱疫苗 QDENGA 最近在阿根廷和泰國獲得批准，我們對在流行病和旅遊市場上看到的勢頭感到高興。我將在下一張幻燈片中進一步討論 QDENGA。在其他監管進展中，我們已在美國申請 GAMMAGARD LIQUID 用於治療慢性炎症性脫髓鞘性多發性神經病 (CIDP)。繼去年第四季度向 CIDP 提交 HYQVIA 後，這代表了我們 PDT 免疫學產品組合中 2 種增長和推出產品的近期適應症擴展機會。

We have also filed fruquintinib in the U.S. and Europe for previously treated metastatic colorectal cancer, receiving priority review designation in the U.S. Metastatic colorectal cancer remain an area of high unmet need with poor outcomes and limited treatment options, and we are pleased to take a step further towards advancing treatment for patients. Priority Review in the U.S. has also been granted for TAK-755 for congenital thrombotic thrombocytopenic purpura, or cTTP [and ultra-rare] bleeding disorder also with limited treatment options.

我們還在美國和歐洲提交了呋喹替尼用於既往治療過的轉移性結直腸癌的申請，並在美國獲得了優先審評資格。轉移性結直腸癌仍然是一個需求未得到高度滿足的領域，其結果不佳且治療選擇有限，我們很高興採取這一步進一步推進患者的治療。 TAK-755 在美國也獲得了優先審查，用於治療先天性血栓性血小板減少性紫癜或 cTTP [和極其罕見] 出血性疾病，治療選擇也有限。

In neuroscience, our ongoing Phase IIb study of oral orexin agonist TAK-861 for both narcolepsy type 1 and narcolepsy type 2 is progressing well on track. We believe in the transformative efficacy potential of our orexin program, and this is supported by data published today in the New England Journal of Medicine from our discontinued study of TAK-994. Andy will explain the details in a few minutes.

在神經科學領域，我們正在進行的口服食慾素激動劑 TAK-861 治療 1 型和 2 型發作性睡病的 IIb 期研究進展順利。我們相信我們的食慾素項目具有變革性的功效潛力，這一點得到了今天在《新英格蘭醫學雜誌》上發表的我們已停止的 TAK-994 研究數據的支持。安迪將在幾分鐘內解釋詳細信息。

We are proud of all this progress, which represents the potential of our portfolio to make a meaningful difference in the life of patients and to serve communities around the world.

我們對所有這些進展感到自豪，這代表了我們的產品組合有潛力為患者的生活帶來有意義的改變並為世界各地的社區提供服務。

Turning to updates on our dengue vaccine, QDENGA. We are very early in the launch phase for QDENGA, but we are encouraged by the positive momentum we are seeing in markets where it is now available, and we are already seeing early sign of higher-than-expected demand. We made significant progress in the last quarter with approval in Thailand and Argentina and our first launches in endemic countries, including Brazil and Indonesia. The vaccine's significant progress in endemic countries underscore its strong clinical data and the urgent need for a safe and effective vaccines to prevent dengue fever, which is why we remain laser-focused on endemic markets, which make up roughly 80% to 85% of our projected peak sales of USD 1.6 billion to USD 2 billion.

轉向我們的登革熱疫苗 QDENGA 的更新。我們還處於 QDENGA 推出階段的早期階段，但我們對在現有市場上看到的積極勢頭感到鼓舞，而且我們已經看到了需求高於預期的早期跡象。我們在上個季度取得了重大進展，在泰國和阿根廷獲得批准，並在巴西和印度尼西亞等流行國家首次推出。該疫苗在流行國家取得的重大進展凸顯了其強大的臨床數據以及對安全有效的疫苗來預防登革熱的迫切需求，這就是為什麼我們仍然高度關注流行市場，該市場約占我們市場的80% 至85 %預計銷售額峰值為 16 億美元至 20 億美元。

At the global level too, dengue prevalence has continued to grow. The World Health Organization reported just last week that there have been close to 3 million cases of dengue reported so far this year, already surpassing the 2.8 million cases registered for the entire year of 2022. In travel markets, we have continued to see country level approval and launch across the EU following the EMEA broad approval late last year. In the U.S, we made a difficult decision to voluntarily withdraw our biologics license application filing due to FDA request for additional data, including data that was not part of the previously agreed upon protocol and which could not be addressed within the current review cycle. This decision will not affect our overall approach for TAK-003, QDENGA, which we believe can be extremely effective to limit the public health impact of dengue in endemic countries.

在全球範圍內，登革熱患病率也在持續增長。世界衛生組織上周剛剛報告稱，今年迄今為止已報告了近 300 萬例登革熱病例，已超過 2022 年全年登記的 280 萬例。在旅遊市場，我們繼續看到國家一級的登革熱病例繼去年年底歐洲、中東和非洲地區獲得廣泛批准後，該產品在整個歐盟獲得批准並推出。在美國，由於 FDA 要求提供額外數據，包括不屬於先前商定的方案且無法在當前審查週期內解決的數據，我們做出了自願撤回生物製劑許可申請的艱難決定。這一決定不會影響我們對 TAK-003、QDENGA 的總體方法，我們相信該方法可以非常有效地限制登革熱流行國家的公共衛生影響。

Looking ahead, we are continuing to work closely with WHO and look forward to the release of the recommendation from SAGE, the WHO Advisory Group, which is anticipated later this year. We are also in active discussion with a number of supranational procurement bodies such as the Pan-American Health Organization relating to large-scale procurement following the WHO recommendation. To meet the vaccine's anticipated global demand, we have been expanding our manufacturing capabilities. We recently, in fact, last week, celebrated the opening of a state-of-the-art building dedicated to drug substance manufacturing for our dengue vaccines in Singen, Germany. This was an important step in achieving our goal of end-to-end in-house production capability for QDENGA by 2025 and achieving an annual supply capacity of around $100 million by the end of the decade.

展望未來，我們將繼續與世衛組織密切合作，並期待世衛組織諮詢小組 SAGE 預計在今年晚些時候發佈建議。我們還與一些超國家採購機構（例如泛美衛生組織）就遵循世界衛生組織建議的大規模採購進行積極討論。為了滿足疫苗的預期全球需求，我們一直在擴大我們的生產能力。事實上，我們上週在德國辛根慶祝了一座最先進的大樓的開業，該大樓專門用於生產登革熱疫苗的原料藥。這是我們實現 2025 年 QDENGA 端到端內部生產能力以及到本世紀末實現約 1 億美元年供應能力的目標的重要一步。

While we ramp up our manufacturing capabilities, we are exploring partnership with vaccines manufacturers, especially in endemic countries to secure additional capacity to meet current and future supply needs. We look forward to continued momentum of these programs in 2023 and beyond.

在我們提高生產能力的同時，我們正在探索與疫苗製造商建立合作夥伴關係，特別是在流行國家，以確保額外的產能，以滿足當前和未來的供應需求。我們期待這些計劃在 2023 年及以後繼續保持勢頭。

Now I'd like to turn to our high-level outlook for the near, medium and long term. Based on our current assumption for fiscal year '23, we expect to return to revenue profit and margin growth in the near term, driven largely by the continued expansion of our growth and launch product. We also see significant potential in our late-stage pipeline assets and anticipate significant data and regulatory milestones this year. Following the generic competition for VYVANSE, which will impact revenue and profit growth in fiscal year '23, we will have limited loss of exclusivity exposure until the launch of ENTYVIO biosimilars, which could occur as late as 2032. The momentum for our growth and launch product, combined with our continued investment in R&D, will drive progress in the medium and long term.

現在我想談談我們對近期、中期和長期的高層展望。根據我們目前對 23 財年的假設，我們預計將在短期內恢復收入利潤和利潤率增長，這主要是由我們的增長和推出產品的持續擴張推動的。我們還看到了後期管道資產的巨大潛力，並預計今年將出現重要的數據和監管里程碑。 VYVANSE 的仿製藥競爭將影響 23 財年的收入和利潤增長，在 ENTYVIO 生物仿製藥推出之前，我們的獨家經營權損失將有限，最遲可能在 2032 年推出。我們的增長和推出的動力產品，加上我們對研發的持續投資，將推動中長期的進步。

Looking ahead, we remain committed to returning to core operating profit margin in the low to mid-30s, supported by value creation enabled by data and technology, including AI. We will also continue to evaluate asset-specific business development opportunities to further enhance our pipeline and reinforce our growth profile. Finally, our progressive dividend policy of increasing or maintaining the dividend each year will allow us to continue to return value to shareholders.

展望未來，在數據和技術（包括人工智能）帶來的價值創造的支持下，我們仍然致力於將核心營業利潤率恢復到 30 多歲左右。我們還將繼續評估特定資產的業務發展機會，以進一步增強我們的渠道並增強我們的增長前景。最後，我們每年增加或維持股息的漸進式股息政策將使我們能夠繼續為股東回報價值。

In closing, this quarter demonstrate that our growth strategy remains on track. We continue to deliver on our financial commitment to progress our pipeline and to create long-term value for our stakeholders, while we fulfill our purpose of bringing better health for people and a brighter future for the world.

最後，本季度表明我們的增長戰略仍然步入正軌。我們繼續履行我們的財務承諾，以推進我們的產品線並為利益相關者創造長期價值，同時實現為人們帶來更好的健康和為世界帶來更光明的未來的目標。

With that, I will turn the call over to Andy to update you on our pipeline. Thank you.

這樣，我會將電話轉給安迪，向您通報我們的管道最新情況。謝謝。

Thank you very much, Christophe, and a big hello to everyone on today's call.

非常感謝克里斯托夫，並向參加今天電話會議的所有人問好。

If we go to next slide, please. Our pipeline continues to advance, including considerable progress with the TAK-279 and orexin franchises, which we will describe later in this presentation. This quarter, the rest of our pipeline featured a number of incremental but important program milestones and a few small headwinds. As Christophe just mentioned, important regulatory milestones include filing fruquintinib in both the U.S. and EU for metastatic colorectal cancer, filing TAK-755 in again the U.S. and EU for congenital thrombotic thrombocytopenic purpura or cTTP, and finally, GAMMAGARD LIQUID in the U.S. for chronic inflammatory demyelinating polyneuropathy, or CIDP. Fruquintinib and TAK-755 are granted priority reviews by the FDA, reflecting their potential for increased effectiveness and/or better safety in areas of high unmet medical need. If approved, TAK-755 would be the first available therapy for routine prophylaxis and congenital TTP.

請轉到下一張幻燈片。我們的產品線繼續推進，包括 TAK-279 和 orexin 特許經營權的重大進展，我們將在本演示文稿後面對此進行描述。本季度，我們的其餘管道出現了一些漸進但重要的計劃里程碑和一些小阻力。正如Christophe 剛才提到的，重要的監管里程碑包括在美國和歐盟申請用於治療轉移性結直腸癌的呋喹替尼，再次在美國和歐盟申請用於治療先天性血栓性血小板減少性紫癜或cTTP的TAK-755，以及最後在美國申請用於治療慢性疾病的GAMMAGARD LIQUID。炎症性脫髓鞘性多發性神經病（CIDP）。呋喹替尼和 TAK-755 獲得 FDA 優先審查，反映出它們在醫療需求未得到滿足的領域提高有效性和/或提高安全性的潛力。如果獲得批准，TAK-755 將成為常規預防和先天性 TTP 的第一個可用療法。

Supporting these and other programs were a number of key publications and presentations. These include HYQVIA's Phase III ADVANCE-1 study results, demonstrating an approximate 10% relapse rate with HYQVIA. This is the lowest relapse rate observed in CIDP maintenance studies across mechanisms. Fruquintinib data from FRESCO-2 was published in The Lancet and showed a greater than 30% increase in overall survival versus the control arm in patients with metastatic colorectal cancer. In June, TAK-755 data were presented. These data demonstrate a reduction in the incidence of thrombocytopenia by 60% versus the standard of care and no acute TTP events were observed.

支持這些和其他計劃的是許多重要的出版物和演示。其中包括 HYQVIA 的 III 期 ADVANCE-1 研究結果，證明 HYQVIA 的複發率約為 10%。這是 CIDP 維持研究中跨機制觀察到的最低復發率。 FRESCO-2 的呋喹替尼數據發表在《柳葉刀》上，結果顯示，與對照組相比，轉移性結直腸癌患者的總生存期增加了 30% 以上。 6 月，TAK-755 數據公佈。這些數據表明，與標準護理相比，血小板減少症的發生率降低了 60%，並且沒有觀察到急性 TTP 事件。

And also in June, updated data from the Phase II SEQUOIA study of fazirsiran was presented at the European Association for the Study of Liver Congress or EASL. Fazirsiran continued to demonstrate a dose-dependent reduction in the pathological alpha-1 antitrypsin Z-AAT protein in both serum and liver, leading to directional decreases in liver inflammation and fibrosis. We've started our Phase III Redwood study earlier this year.

同樣在 6 月，fazirsiran II 期 SEQUOIA 研究的最新數據在歐洲肝臟研究協會大會 (EASL) 上公佈。 Fazirsiran 繼續證明血清和肝臟中病理性 α-1 抗胰蛋白酶 Z-AAT 蛋白呈劑量依賴性減少，導致肝臟炎症和纖維化的定向減少。我們今年早些時候開始了第三期紅木研究。

Now headwinds this quarter include TAK-611 for metachromatic leukodystrophy or MLD, which missed its primary and secondary endpoints in our Phase II study. We are disappointed and wish to express our gratitude to the MLD children, parents and caregivers. We're currently evaluating options, but given these outcomes the program unfortunately is likely to be discontinued. Following a planned interim analysis, the Phase III EXCLAIM-2 trial was stopped for futility. The trial compared EXKIVITY monotherapy to chemotherapy in first-line non-small cell lung cancer with exon 20 insertion mutations. We will be engaging with regulators regarding these data and determining next steps for the program. As a reminder, EXKIVITY demonstrated a median duration of response of 17.5 months and a median overall survival of 24 months in patients being treated in the second line who had progressed after chemotherapy.

目前，本季度的不利因素包括治療異染性腦白質營養不良或 MLD 的 TAK-611，該藥物在我們的 II 期研究中未能達到主要和次要終點。我們感到失望，並向 MLD 兒童、家長和照顧者表示感謝。我們目前正在評估各種選擇，但不幸的是，考慮到這些結果，該計劃可能會停止。經過計劃的中期分析後，III 期 EXCLAIM-2 試驗因徒勞而停止。該試驗將 EXKIVITY 單藥療法與化療用於治療具有外顯子 20 插入突變的一線非小細胞肺癌進行比較。我們將與監管機構就這些數據進行接觸，並確定該計劃的後續步驟。需要提醒的是，EXKIVITY 在化療後病情進展的二線治療患者中顯示，中位緩解持續時間為 17.5 個月，中位總生存期為 24 個月。

And lastly, as Christophe discussed, we had some positive and negative developments for QDENGA this quarter. Very important to recognize that the unmet need for a dengue vaccine is not equally distributed around the world. We remain confident in the overall benefits of QDENGA. However, timing of approval may vary depending on local needs and experience. Finally, yesterday, as Christophe again mentioned Phase IIb data from the first-ever oral orexin receptor 2 agonist, TAK-994, was published in the New England Journal of Medicine.

最後，正如 Christophe 所討論的，本季度我們在 QDENGA 方面取得了一些積極和消極的進展。認識到登革熱疫苗未滿足的需求在世界各地的分佈並不均勻，這一點非常重要。我們對 QDENGA 的整體優勢仍然充滿信心。然而，批准的時間可能會根據當地的需求和經驗而有所不同。最後，昨天，正如 Christophe 再次提到的，首個口服食慾素受體 2 激動劑 TAK-994 的 IIb 期數據發表在《新英格蘭醫學雜誌》上。

Next slide, please. We conducted a Phase IIb dose-ranging trial that tested 3 doses of TAK-994 in an 8-week study with the option for patients to continue into an 8-week extension. The trial was stopped early due to liver toxicity. Now even with a truncated study, the impressive efficacy data indicate orexin receptor 2 is a promising novel biologic target for patients with narcolepsy type 1. The mean wakefulness test scores range from 26 to 35 minutes on a placebo-adjusted basis. For benchmarking, currently marketed agents have shown a placebo-adjusted benefit of 8 minutes or less. Similar effects were observed with the Epworth Sleepiness Scale, a subjective test used to measure daytime sleepiness, in which patients were normalized to equivalent levels as those seen in healthy subjects at all doses. And weekly cataplexy rates were reduced or abolished, again at all doses tested.

請下一張幻燈片。我們進行了一項 IIb 期劑量範圍試驗，在為期 8 週的研究中測試了 3 劑 TAK-994，患者可以選擇繼續延長 8 週。由於肝毒性，試驗提前停止。現在，即使是一項被刪節的研究，令人印象深刻的療效數據表明，食慾素受體2 是1 型發作性睡病患者的一個有前途的新型生物靶標。在安慰劑調整的基礎上，平均覺醒測試分數範圍為26 至35 分鐘。對於基準測試，目前上市的藥物經安慰劑調整後的效果為 8 分鐘或更短。 Epworth 嗜睡量表也觀察到了類似的效果，這是一種用於測量白天嗜睡的主觀測試，在該量表中，患者在所有劑量下都被標準化到與健康受試者相同的水平。在所有測試劑量下，每週的猝倒率均降低或消除。

We believe orexin 2 receptor agonist may be the first agent to address the underlying cause of narcolepsy type 1, offering the potential for functional cures. We are applying our learnings from TAK-994 and our deep understanding of orexin biology as we advance the research and development for multiple orexin assets. For example, TAK-861 has been enrolling ahead of schedule in 2 Phase IIb trials that started in January of this year, one for narcolepsy type 1 and a second for narcolepsy type 2. TAK-861 is a more potent agent than TAK-994 and thus provides efficacy at a much lower dose, therefore significantly reducing the potential for adverse effects, including liver toxicity.

我們相信，食慾素 2 受體激動劑可能是第一個解決 1 型發作性睡病根本原因的藥物，為功能性治愈提供了潛力。我們正在運用從 TAK-994 中學到的知識以及對食慾素生物學的深刻理解，推進多種食慾素資產的研究和開發。例如，TAK-861已提前參加今年1月開始的兩項IIb期試驗，一項針對1型發作性睡病，另一項針對2型發作性睡病。TAK-861是比TAK-994更有效的藥物從而以低得多的劑量提供功效，從而顯著降低潛在的不良反應，包括肝毒性。

We are very pleased to report that a recently conducted external review by the Data Safety Monitoring Committee confirmed no liver toxicity signals to date. In addition, nearly all of the patients that completed the trial to date have enrolled in the long-term extension study and will be followed for up to 102 weeks. We are expecting a go, no-go decision to advance to Phase III in the next fiscal year.

我們非常高興地報告，數據安全監測委員會最近進行的外部審查確認迄今為止沒有肝毒性信號。此外，迄今為止完成試驗的幾乎所有患者都參加了長期擴展研究，並將進行長達102週的隨訪。我們預計下一財年將做出推進到第三階段的決定。

TAK-925, our IV orexin receptor 2 agonist, showed exciting data earlier this year. In sedated healthy volunteers, TAK-925 reversed opioid-induced respiratory depression and sedation without impacting pain control. The Phase II trial was started and is on track to have proof-of-concept in fiscal year 2024, which will inform the registrational studies. Later this year, we plan to file an IND for our next-generation oral orexin receptor 2 agonist. Our goal is to expand into additional indications by developing orexin agonists that are tailored to meet unmet patient needs and ultimately make a meaningful impact on patients' lives.

TAK-925 是我們的 IV 食慾素受體 2 激動劑，今年早些時候顯示了令人興奮的數據。在服用鎮靜劑的健康志願者中，TAK-925 逆轉了阿片類藥物引起的呼吸抑制和鎮靜作用，且不影響疼痛控制。 II 期試驗已啟動，預計將在 2024 財年進行概念驗證，為註冊研究提供信息。今年晚些時候，我們計劃為下一代口服食慾素受體 2 激動劑提交 IND 申請。我們的目標是通過開發專為滿足未滿足的患者需求而定制的食慾素激動劑來擴展到其他適應症，並最終對患者的生活產生有意義的影響。

Next slide, please. Depicted here our exciting late-stage development programs. TAK-279, our highest priority, is on track to start a Phase III program in psoriasis later this fiscal year. We continue to believe we have a best-in-class oral therapy for psoriasis. We will have a Phase IIb readout for psoriatic arthritis this fall and are preparing at risk to start a pivotal development program for these patients in fiscal year 2024. We are accelerating development of TAK-279 additionally in Crohn's disease, ulcerative colitis and systemic lupus erythematosus as well as exploring a range of other indications. These expansion opportunities are being developed in parallel with psoriasis.

請下一張幻燈片。這裡描述了我們激動人心的後期開發計劃。 TAK-279 是我們的首要任務，有望在本財年晚些時候啟動銀屑病 III 期項目。我們仍然相信我們擁有一流的牛皮癬口服療法。我們將於今年秋天獲得針對銀屑病關節炎的IIb 期試驗結果，並準備在2024 財年冒著風險啟動針對這些患者的關鍵開發計劃。我們正在加速TAK-279 的開發，另外用於治療克羅恩病、潰瘍性結腸炎和系統性紅斑狼瘡以及探索一系列其他適應症。這些擴張機會與牛皮癬同時發展。

Finally, we want to remind everyone that we have important life cycle management approvals and data readouts later this year. These include potential approval of ENTYVIO subcutaneous in the U.S. for ulcerative colitis and ALOFISEL Phase III data for perianal fistulas. Life cycle management program milestones can be found in the appendix. Now at this point, thank you, very much. I'll turn it over to Costa.

最後，我們想提醒大家，今年晚些時候我們將獲得重要的生命週期管理批准和數據讀出。其中包括用於治療潰瘍性結腸炎的 ENTYVIO 皮下注射可能在美國獲得批准，以及用於治療肛周瘺的 ALOFISEL III 期數據。生命週期管理計劃的里程碑可以在附錄中找到。現在，非常感謝您。我會把它交給科斯塔。

Thank you, Andy. And hello, everyone. This is Costa Saroukos speaking. Today, I'll walk you through the financial highlights of our fiscal 2023 Q1 results. Starting with the top line. Revenue was JPY 1.06 trillion or USD 7.3 billion, delivering strong growth of 3.7% versus prior year at a constant exchange rate or 8.9% on an actual basis, reflecting foreign exchange upside from the depreciation of the yen. Our top line performance was driven by our growth and launch products, which represents approximately 40% of total revenue and grew at 16.2% at constant exchange rate.

謝謝你，安迪。大家好。我是科斯塔·薩魯科斯。今天，我將向您介紹 2023 財年第一季度業績的財務亮點。從頂線開始。收入為 1.06 萬億日元（73 億美元），按固定匯率計算較上年強勁增長 3.7%，實際增長 8.9%，反映了日元貶值帶來的外匯上漲空間。我們的營收業績是由我們的增長和推出的產品推動的，該產品約佔總收入的 40%，按固定匯率計算增長率為 16.2%。

Core operating profit was JPY 326.3 billion or USD 2.3 billion with a core operating profit margin of 30.8%. Reported operating profit was JPY 168.6 billion. We continue to see stable cash generation from the business with operating cash flow up 9.7% to JPY 92.4 billion. Free cash flow is negative at minus JPY 207.5 billion, reflecting JPY 223 billion cash out for acquisitions and in-licensing, including TAK-279 and fruquintinib, which occurred in Q1 as expected. Importantly, I want to note that there is no change to our full year free cash flow forecast of JPY 400 billion to JPY 500 billion as these deals were already included in the forecast which we gave in May.

核心營業利潤為 3,263 億日元（23 億美元），核心營業利潤率為 30.8%。報告營業利潤為 1,686 億日元。我們繼續看到該業務產生穩定的現金，運營現金流增長 9.7% 至 924 億日元。自由現金流為負，為負 2075 億日元，反映出用於收購和許可的現金支出為 2230 億日元，其中包括 TAK-279 和呋喹替尼（如預期發生在第一季度）。重要的是，我想指出的是，我們對全年 4000 億至 5000 億日元自由現金流的預測沒有變化，因為這些交易已經包含在我們 5 月份給出的預測中。

I'm also happy to announce that Moody's recently upgraded our credit rating from Baa2+ to Baa1 stable. This is important to highlight because it's a reflection on the strong financial foundation of the business with our robust cash flow outlook and manageable debt profile with 100% of debt at approximately 2% fixed rates.

我還很高興地宣布，穆迪最近將我們的信用評級從 Baa2+ 升級至 Baa1 穩定。強調這一點很重要，因為它反映了公司強大的財務基礎、強勁的現金流前景和可控的債務狀況，100% 的債務利率約為 2% 的固定利率。

With regard to the outlook for full year 2023, there is no change from the guidance we presented in May. As we flagged since the start of the year, starting from Q2, we expect to see more significant loss of exclusivity impact with generic versions of AZILVA having launched in Japan in June, and more importantly, generics of VYVANSE in the U.S. expected to launch in August. Finally, while we are not changing our reported and core forecast at this time, we do see potential -- some potential upside if the current FX rates continue. We'll provide an update on this at our Q2 earnings in October.

關於 2023 年全年展望，我們在 5 月份提出的指引沒有變化。正如我們自今年年初以來所指出的那樣，從第二季度開始，我們預計6 月份在日本推出的AZILVA 仿製藥將導致排他性影響更加顯著，更重要的是，美國的VYVANSE 仿製藥預計將於2019年在美國上市。八月。最後，雖然我們目前沒有改變我們的報告和核心預測，但我們確實看到了潛力——如果當前的匯率繼續下去，可能會出現一些潛在的上行空間。我們將在 10 月份的第二季度財報中提供相關最新信息。

Slide 13 shows our Q1 results in more detail. On the left-hand side, you can see our reported results, with reported operating profit up 12% reflecting revenue growth, completion of inventory step-up related to the Shire acquisition and lower impairment charges compared to the prior year. Meanwhile, reported net profit and reported EPS declined as a result of substantial onetime financial income booked in Q1 of last year. Our core results on the right-hand side. And as mentioned, we saw strong revenue growth of 8.9% or 3.7% at a constant exchange rate, driven by our growth and launch products. Core operating profit grew at 2.3% on an actual foreign exchange basis, with a slight decline of minus 2% at constant exchange rate. This decline reflects product mix due to generic entry and lower COVID-19 vaccine revenues and also continued investment in R&D and data and technology to secure the long-term success of the business. Even with this incremental investment, margins for Q1 remained above [30%.]

幻燈片 13 更詳細地展示了我們第一季度的結果。在左側，您可以看到我們的報告結果，報告的營業利潤增長了 12%，反映出收入增長、與夏爾收購相關的庫存增加的完成以及與上一年相比減值費用的降低。與此同時，由於去年第一季度計入大量一次性財務收入，報告淨利潤和報告每股收益有所下降。我們的核心結果位於右側。如前所述，在我們的增長和推出產品的推動下，我們的收入強勁增長了 8.9% 或按固定匯率計算 3.7%。按實際匯率計算，核心營業利潤增長2.3%，按固定匯率計算略有下降-2%。這一下降反映了由於仿製藥進入和 COVID-19 疫苗收入下降而導致的產品組合，以及為確保業務長期成功而對研發、數據和技術的持續投資。即使有這種增量投資，第一季度的利潤率仍高於 [30%]。

Core net profit and core EPS benefited from a lower core tax rate with core EPS for the quarter of JPY 150, up plus 0.3% versus prior year at the constant exchange rate. And as mentioned on the prior slide, free cash flow reflected the expected cash payments for TAK-279 and fruquintinib, and there is no change to our full year forecast of JPY 400 billion to JPY 500 billion.

核心淨利潤和核心每股收益受益於較低的核心稅率，本季度核心每股收益為 150 日元，按固定匯率計算，較上年同期增長 0.3%。正如上一張幻燈片中提到的，自由現金流反映了 TAK-279 和呋喹替尼的預期現金支付，我們對全年 4000 億日元至 5000 億日元的預測沒有變化。

Slide 14 -- on Slide 14, we highlight our portfolio of growth and launch products, which are the key drivers of top line growth. These products generated JPY 424.1 billion or 40% of total revenue in Q1 with 16.2% growth at constant exchange rate. Within our 5 key business areas, GI grew at 3% on a constant exchange rate, a slight slowdown versus last year, mainly due to generic entry of DEXILANT in January this year. Our largest product, ENTYVIO, continues to perform well with growth of 7%. This is a little behind our expectations for the full year, reflecting single-digit market growth, timing of U.S. inventory shipments in the prior year and pricing headwinds in Europe. ENTYVIO maintains the lead in U.S. market share both in overall IBD prescriptions and in IBD bio-naïve new patient starts. And with an approval decision in the U.S. on the subcutaneous device expected in the coming months, we remain fully confident in the continued growth outlook for the product.

幻燈片 14——在幻燈片 14 上，我們重點介紹了我們的增長和推出產品組合，它們是營收增長的關鍵驅動力。這些產品創造了 4,241 億日元，佔第一季度總收入的 40%，按固定匯率計算增長 16.2%。在我們的 5 個關鍵業務領域中，GI 按固定匯率計算增長了 3%，比去年略有放緩，主要是由於今年 1 月份 DEXILANT 仿製藥上市。我們最大的產品 ENTYVIO 繼續表現良好，增長了 7%。這略低於我們對全年的預期，反映出個位數的市場增長、上一年美國庫存發貨的時間以及歐洲的定價逆風。 ENTYVIO 在 IBD 整體處方和 IBD 生物新手新患者啟動方面均保持美國市場份額的領先地位。隨著美國預計在未來幾個月內批准該皮下裝置，我們對該產品的持續增長前景仍然充滿信心。

In rare diseases, TAKHZYRO continues its strong momentum with growth of 15%, having successfully launched now in 56 countries and with sustained demand in the U.S. We also recently launched in the pediatric indication in the U.S., making it the first HAE product indicated for using children over 2 years old. We also see continued launch successful intensity, up 71%, with strong market penetration in the U.S. and rapid geographic expansion within Europe.

在罕見病領域，TAKHZYRO 繼續保持強勁勢頭，增長15%，目前已在56 個國家成功上市，並在美國擁有持續需求。我們最近還在美國推出了兒科適應症，使其成為第一個用於使用的HAE 產品2歲以上兒童。我們還看到產品發布的成功率持續上升，高達 71%，美國市場滲透率強勁，歐洲地域擴張迅速。

PDT Immunology continues to deliver outstanding growth of 24%, including 23% growth of immunoglobulin and 36% growth of albumin. Both our IG and albumin products continue to see strong demand, with albumin also benefiting in Q1 from recovery in China following the lockdowns in prior year. We have continued to expand our plasma donation center network, adding 3 more centers in Q1 with the intent to increase by more than 20 new centers by the end of the fiscal year. And we have seen donor compensation continuing on a downward trend since fiscal year 2022 after significant increases during the pandemic.

PDT免疫學繼續實現24%的出色增長，其中免疫球蛋白增長23%，白蛋白增長36%。我們的 IG 和白蛋白產品的需求繼續強勁，白蛋白在第一季度也受益於中國在去年封鎖後的複蘇。我們繼續擴大血漿捐贈中心網絡，在第一季度新增 3 個中心，併計劃在本財年末增加 20 多個新中心。我們發現，在疫情期間捐助者報酬大幅增加後，自 2022 財年以來，捐助者報酬繼續呈下降趨勢。

Next is oncology, which continues to decline as a result of VELCADE generics. However, the timing of loss of exclusivity in May 2022 does mean that the impact should wash out in the coming quarters. Excluding VELCADE, the rest of the portfolio grew 5%, driven by products such as ALUNBRIG, EXKIVITY, ADCETRIS and ICLUSIG. Finally, Neuroscience had a very strong performance in Q1 with growth of 17% with VYVANSE benefiting from the expanding ADHD adult population as well as lower supply of other ADHD medicines in the U.S. However, as a reminder, we are expecting multiple VYVANSE generics to enter the U.S. market in August this year.

其次是腫瘤學，由於 VELCADE 仿製藥的出現，該領域的銷售額持續下降。然而，2022 年 5 月失去獨家經營權的時間確實意味著影響應該會在未來幾個季度消失。除 VELCADE 外，在 ALUNBRIG、EXKIVITY、ADCETRIS 和 ICLUSIG 等產品的推動下，其餘產品組合增長了 5%。最後，神經科學在第一季度表現非常強勁，增長了17%，VYVANSE 受益於ADHD 成年人口的擴大以及美國其他ADHD 藥物供應的減少。不過，提醒一下，我們預計多種VYVANSE 仿製藥將進​​入市場今年8月登陸美國市場。

Finally, the Other segment is declining in Q1, mainly due to the lower revenue from COVID-19 vaccines in Japan. However, this Other segment now includes our dengue vaccine, QDENGA, our newest growth and launch product, which is seeing strong initial demand in both endemic and travel markets.

最後，其他部門在第一季度出現下滑，主要是由於日本 COVID-19 疫苗的收入下降。然而，這個“其他”細分市場現在包括我們的登革熱疫苗 QDENGA，這是我們最新的增長和推出產品，該產品在流行病和旅遊市場上都出現了強勁的初始需求。

On Slide 15, you can see that versus prior year, the growth and launch products were the main driver of the 3.7% growth at constant exchange rate, more than offsetting the headwinds from loss of exclusivity and lower coronavirus vaccine revenue. On top of this solid growth, we had a constant exchange rate upside on the foreign exchange tailwind due to the depreciation of the yen, taking our top line growth on an actual FX basis to 8.9%.

在幻燈片15 中，您可以看到，與去年相比，增長和上市產品是按固定匯率計算3.7% 增長的主要推動力，足以抵消獨家經營權喪失和冠狀病毒疫苗收入下降帶來的不利影響。除了這種穩健的增長之外，由於日元貶值，我們在外匯順風的作用下匯率持續上漲，使我們的實際外匯收入增長達到 8.9%。

Moving to the year-on-year core operating profit bridge on Slide 16. Here, you can see how loss of exclusivity and coronavirus vaccines are having a larger impact on profit compared to revenue due to their higher margins, impacting our product mix. On the investment side, we continue to allocate resources to R&D to support high potential programs such as TAK-279 and our orexin franchise, while also making substantial investment in data and technology, including AI across the value chain.

轉到幻燈片16 上的同比核心營業利潤橋樑。在這裡，您可以看到獨家經營權的喪失和冠狀病毒疫苗由於利潤率較高而對利潤產生的影響大於收入，從而影響了我們的產品組合。在投資方面，我們繼續向研發分配資源，以支持 TAK-279 和我們的 orexin 特許經營權等高潛力項目，同時也在數據和技術方面進行大量投資，包括整個價值鏈的人工智能。

We believe these investments will have a transformational impact on Takeda's long-term competitiveness. And therefore, we continue to allocate capital in these areas as they will play a major role in our return to growth in the near and long term. At the same time, we are applying strict cost discipline to hold other OpEx flat year-on-year.

我們相信這些投資將對武田的長期競爭力產生變革性影響。因此，我們繼續在這些領域配置資本，因為它們將在我們近期和長期恢復增長中發揮重要作用。與此同時，我們正在實施嚴格的成本控制，以保持其他運營支出同比持平。

All these factors combined result in a Q1 core operating profit decline of minus 2% on a constant exchange rate basis, but when including foreign exchange benefit, we realized growth of 2.3%.

所有這些因素綜合起來，導致第一季度核心營業利潤按固定匯率計算下降-2%，但考慮到外匯收益，我們實現了 2.3% 的增長。

Finally, moving to Slide 17 and our outlook for full year fiscal 2023. Based on the Q1 results, we do not see any need to make changes to our management guidance or our reported and core forecast at this time. We are still expecting a significant loss of exclusivity impact in the remainder of the year due to VYVANSE and AZILVA, and therefore, we are keeping our management guidance unchanged: low single-digit percentage decline in revenue, low 10s percentage decline in core operating profit and low 20s percentage decline in core EPS or on a constant exchange rate basis. With regard to the reported and core forecast on an actual FX basis, there is some potential upside if current FX rates continue. We'll continue to monitor foreign exchange as well as the underlying business, and we'll revisit our full year outlook at the Q2 earnings announcement in October.

最後，轉向幻燈片 17 以及我們對 2023 財年全年的展望。根據第一季度的業績，我們認為目前沒有必要對我們的管理指導或報告的核心預測進行更改。我們仍然預計，由於 VYVANSE 和 AZILVA，今年剩餘時間裡獨家經營權的影響將顯著喪失，因此，我們將維持我們的管理指導不變：收入下降個位數百分比，核心營業利潤下降 10 個百分點核心每股收益或按固定匯率計算的下降幅度為20 多歲。就以實際匯率為基礎的報告和核心預測而言，如果當前匯率持續下去，則存在一些潛在的上行空間。我們將繼續監控外匯以及基礎業務，並將在 10 月份的第二季度收益公告中重新審視全年展望。

Thank you for your attention, and I'd like to now open it up for Q&A. Thank you.

感謝您的關注，我現在想打開它進行問答。謝謝。

[Interpreted] Thank you. Now we would like to take questions from the participants. And in the Q&A session, Christophe, Andy, Costa and Ramona Sequeira, Global Portfolio Division President; Julie Kim, U.S. Business Unit President; Giles Platford, PDT Business Unit President are also joining.

[已翻譯] 謝謝。現在我們想回答與會者的提問。在問答環節，Christophe、Andy、Costa 和全球投資組合部總裁 Ramona Sequeira ； Julie Kim，美國業務部總裁； PDT 業務部總裁 Giles Platford 也將加入。

(Operator Instructions) The first question from Yamaguchi-san Citi Group, please.

（操作員指示） 第一個問題是山口山花旗集團的問題。

This is Yamaguchi for Citi. So I have 2 questions. The first question regarding your comments on ENTYVIO. You talk about the market is a little bit slow, and there's a price pressure in Europe as well, and also there is some kind of an (inaudible) effect of inventory building up. Can you elaborate a little bit, especially in the United States, which is the core market of this product, is weak. What is the case? Is it coming from the HUMIRA or other biosimilars coming to the market or it just needs related to the COVID? So that's the first question on ENTYVIO market weakness -- sorry, ENTYVIO weakness comments. That's the first one.

這是花旗銀行的山口。所以我有兩個問題。第一個問題是關於您對 ENTYVIO 的評論。您談到市場有點緩慢，歐洲也存在價格壓力，而且庫存增加也存在某種（聽不清）效應。能否詳細說明一下，尤其是美國這個產品的核心市場，比較薄弱。這是什麼情況？它是來自 HUMIRA 或其他上市的生物仿製藥，還是只需要與新冠病毒相關？這是關於 ENTYVIO 市場疲軟的第一個問題 - 抱歉，ENTYVIO 疲軟評論。這是第一個。

The second one is regarding 994 on the New England Journal of Medicine, it is really efficacious, which is really unfortunate situation out there because it did show the results. But at the same time, you have a more 861 and also talk you about some next generation products. Can you give me the sense that you are at kind of efficacy level of which you are sort of getting so far, as far the 861 is concerned. It's the same range of 994? Is it better than 994, about the efficacy level and also the second-relation product as well.

第二個是關於《新英格蘭醫學雜誌》上的994，它確實很有效，這確實是不幸的情況，因為它確實顯示了結果。但同時，你多了一個861，也給你講了一些下一代產品。您能給我一種感覺嗎？就 861 而言，您目前已經達到了某種功效水平。和994是同一個範圍嗎？是不是比994好，關於功效水平，也是二系產品。

Thank you, Yamaguchi-san, for your question. So the first question on ENTYVIO and the market performance. So first, I'd like to ask Julie to comment on the situation in the U.S. And then back to Ramona, has anything to add on the situation in Europe or other regions. And then on 994, the New England Journal posting. What implications does this have on 861? And more particularly, what are the efficacy levels that we've seen so far for 861? And what are our expectations for the next generation oral orexin agonist. I'd like to ask Andy to comment on that one.

謝謝山口先生的提問。那麼第一個問題是關於ENTYVIO和市場表現。首先，我想請朱莉對美國的局勢發表評論。然後回到雷蒙娜，對歐洲或其他地區的局勢有什麼補充。然後在 994，《新英格蘭日報》發帖。這對 861 有何影響？更具體地說，到目前為止我們所看到的 861 的功效水平是多少？我們對下一代口服食慾素激動劑的期望是什麼？我想請安迪對此發表評論。

This is Julie. So thank you for the question, Yamaguchi-san. In terms of ENTYVIO, I'm sorry, can you hear me?

這是朱莉。謝謝你的提問，山口先生。關於ENTYVIO，抱歉，你能聽到我說話嗎？

Yes, sorry.

是的，抱歉。

Okay, okay. Sorry about that. So in terms of ENTYVIO in the U.S., a few comments in regard to your questions, as you had multiple components in your question there. First, in terms of the impact of biosimilars to HUMIRA, it's a little bit too early to say the impact of those biosimilars. We are monitoring that closely. But so far, as anticipated, the biosimilars are really within class versus having an effect across different products within IBD. When we look at ENTYVIO performance, in particular, we're pleased with the very strong market share of ENTYVIO, and we continue to be the leader when it comes to IBD share and particularly in terms of bio-naïve share. For the market growth, as you mentioned there, market growth is still in the single digits. So it hasn't returned to double-digit growth as we've seen in the past. So those are the different parameters of the impact on ENTYVIO in the U.S.

好吧好吧。對於那個很抱歉。因此，就美國的 ENTYVIO 而言，針對您的問題提出一些評論，因為您的問題中有多個組成部分。首先，就生物仿製藥對 HUMIRA 的影響而言，現在說這些生物仿製藥的影響還為時過早。我們正在密切監視這一情況。但到目前為止，正如預期的那樣，生物仿製藥確實屬於同類藥物，而不是對 IBD 內的不同產品產生影響。當我們特別關注 ENTYVIO 的表現時，我們對 ENTYVIO 非常強勁的市場份額感到滿意，並且在 IBD 份額方面，特別是在生物製劑份額方面，我們繼續保持領先地位。對於市場增長，正如您所提到的，市場增長仍處於個位數。因此，它並沒有像我們過去看到的那樣恢復兩位數增長。這些是對美國 ENTYVIO 影響的不同參數。

Ramona, do you want to add anything for Europe?

雷蒙娜，你想為歐洲添加什麼嗎？

Thank you, Julie. Yes, I can comment a little bit outside the U.S. So in general, the market is growing double digits and actually volume is also growing double digits OUS. Really, the impact OUS is due to rebates and price cuts in Europe specifically. The underlying fundamentals, though, are looking good. So share is increasing, the market is growing. We do continue to lead in new starts globally both in U.S. and outside the U.S. As you know, we've got the subcu expecting to launch in the U.S. later this year, and we're continuing our evidence generation, Phase IV trials, looking at ENTYVIO in different lines of therapy. So we feel the fundamentals are looking good and continue to keep an eye on ENTYVIO as we go through the year.

謝謝你，朱莉。是的，我可以在美國以外的地方發表一些評論。所以總的來說，市場正在以兩位數的速度增長，實際上，OUS 的銷量也在以兩位數的速度增長。實際上，OUS 的影響主要是由於歐洲的回扣和降價造成的。不過，基本面看起來不錯。所以份額在增加，市場在增長。我們確實繼續在美國和美國以外的全球新項目中處於領先地位。如您所知，我們的 subcu 預計將於今年晚些時候在美國推出，我們正在繼續我們的證據生成、第四階段試驗，尋找在ENTYVIO 的不同療法中。因此，我們認為基本面看起來不錯，並在這一年中繼續關注 ENTYVIO。

Yes. Thank you, Chris. Yamaguchi-san, thank you very much. So we're just so excited to have now the 994 data out there in the New England Journal publication, both us and the principal investigators with whom we've been working for many years. And it's terrific that you now have a chance to see these data and understand why we're so enthusiastic about this mechanism. The question with respect to 861, 861 has every possibility to be as strong as 994 in terms of its efficacy profile. We don't have enough data now to know whether it will be equivalent to 994 across the multiple different parameters.

是的。謝謝你，克里斯。山口先生，非常感謝你。因此，我們和與我們合作多年的主要研究人員都非常高興能夠在《新英格蘭雜誌》出版物中看到 994 數據。很高興您現在有機會看到這些數據並了解為什麼我們對這種機制如此熱衷。關於 861 的問題，就其功效而言，861 很可能與 994 一樣強大。我們現在沒有足夠的數據來知道它在多個不同參數上是否相當於 994。

And as you saw with 994, we're essentially able to take a type 1 narcolepsy patient, make them look like a healthy individual. The issue with 861 is going to be dose. So we're very thoughtful in terms of what our dose selection will be. And as we've said, because we want to be careful around the potential for liver toxicity, we'll cap our daily dose at somewhere around 10 milligrams. And so the question that we'll be asking with the Phase IIb study is, with a dose cap, what does that efficacy profile look like? And those are data that we'll have in-house at some point over the course of this year and we'll share next year and will be the basis of a go, no-go decision to Phase III.

正如您在 994 中看到的那樣，我們基本上能夠接受 1 型發作性睡病患者，讓他們看起來像一個健康的人。 861 的問題在於劑量。因此，我們在劑量選擇方面非常深思熟慮。正如我們所說，因為我們要小心潛在的肝毒性，所以我們將每日劑量限制在 10 毫克左右。因此，我們在 IIb 期研究中要問的問題是，在劑量上限的情況下，療效概況是什麼樣的？這些是我們將在今年某個時候內部獲得的數據，我們將在明年分享，並將成為第三階段進行或不進行決定的基礎。

With respect to our backup programs, our first next-generation molecule will be coming into the clinic later this year, and they're really 2 intents behind the backup program. The first, if 861 doesn't have, what I would say, is a maximally efficacious profile in type 1 narcolepsy, then there's the potential for a next-in-class best-in-class. If 861 is the ultimate molecule for type 1 narcolepsy with maximal benefits, then our intent would be to develop these molecules in -- across a range of other indications. And then just -- I'll just add that we've only presented in this New England Journal paper, a subset of the overall data that we have from our oral orexin. And there's data that point us in many different directions for this particular pathway. And so that's one of the reasons we've been so really proactive in bringing a suite of molecules forward.

關於我們的備份程序，我們的第一個下一代分子將於今年晚些時候進入臨床，它們實際上是備份程序背後的兩個意圖。第一個，如果 861 沒有，我想說的是，對 1 型發作性睡病最有效，那麼就有可能成為同類中的最佳藥物。如果 861 是治療 1 型發作性睡病的終極分子，具有最大的益處，那麼我們的目的就是開發這些分子，用於一系列其他適應症。然後，我要補充一點，我們僅在《新英格蘭雜誌》的這篇論文中介紹了我們從口腔食慾素中獲得的總體數據的一個子集。有數據為我們指明了這條特定途徑的許多不同方向。這就是我們如此積極主動地推出一系列分子的原因之一。

Thank you very much. Moving to the next question. We'd like to call on Seiji Wakao from JPMorgan.

非常感謝。轉到下一個問題。我們想請摩根大通的 Seiji Wakao 發言。

[Interpreted] Yes. This is Wakao, JPMorgan. I have 2 questions. In this first quarter, the gross margin is lower now. Why is this? Is this according to plan? And PDT margin, I was expecting to see some improvement there. But what is your view on this? And I just want to understand whether the margin is improving for our PDT business.

[解釋] 是的。我是摩根大通的若尾。我有 2 個問題。在第一季度，毛利率現在較低。為什麼是這樣？這是按照計劃進行的嗎？至於 PDT 利潤率，我預計會看到一些改善。但您對此有何看法？我只是想了解我們的 PDT 業務的利潤率是否有所改善。

And continuing on what Yamaguchi-san asked, 994 and 861. I read the New England Journal. And the factors for liver toxicity for 994 was reactive metabolites, impact of reactive metabolites. What about 861? Is it a different type of a metabolite? Or are you going to do dosing correctly so that the metabolites is lower or smaller? Can you please explain again why you expect lower liver toxicity with 861.

繼續山口先生的要求，994和861。我讀了《新英格蘭日報》。 994的肝毒性因素是反應性代謝物、反應性代謝物的影響。 861呢？它是一種不同類型的代謝物嗎？或者您是否要正確給藥以使代謝物更低或更小？您能否再次解釋一下為什麼您預計 861 的肝毒性較低。

Thank you for the question. So the first question was on reasons for the lower gross margin in Q1 versus prior year. Also related to that, the margins in the PDT business, how are they improving? So I'd like to ask Costa to take that question. And then the next question was on 994 and 861 and the reactive metabolites being the cause of liver injury for TAK-994. What's our thinking on that around the 861 program. I'd like to ask Andy to comment on that.

感謝你的提問。因此，第一個問題是第一季度毛利率低於去年同期的原因。同樣與此相關的是，PDT 業務的利潤率如何改善？所以我想請科斯塔回答這個問題。接下來的問題是關於 994 和 861 以及反應性代謝物是 TAK-994 肝損傷的原因。我們對 861 計劃有何看法？我想請安迪對此發表評論。

Thank you very much, Wakao-san, for your question. Regarding the core gross profit margin, as you rightfully highlighted, there is a softening versus Q1 of last year. And the main drivers for that are 3. The first one being the impact of loss of exclusivity products such as VELCADE, loss of exclusivity happened in May of 2022. So we're seeing the bulk of the impact of Q1 this year versus last year. So that's VELCADE loss of exclusivity headwinds as well as AZILVA which we experienced loss of exclusivity in Japan in June, and furthermore, DEXILANT in the U.S. loss of exclusivity in Q1. So those 3 products alone have very high margins. So having that loss of exclusivity had an impact on the overall product mix there.

非常感謝若尾先生的提問。關於核心毛利率，正如您正確強調的那樣，與去年第一季度相比有所疲軟。其主要驅動因素有3 個。第一個是VELCADE 等產品獨家經營權喪失的影響，獨家經營權的喪失發生在2022 年5 月。因此，與去年相比，我們看到了今年第一季度的大部分影響。這就是 VELCADE 失去獨家經營權的逆風以及 AZILVA，我們 6 月份在日本經歷了獨家經營權的喪失，此外，DEXILANT 在美國第一季度也失去了獨家經營權。因此，僅這 3 個產品的利潤率就非常高。因此，排他性的喪失對那裡的整體產品組合產生了影響。

The second one is the European [pullbacks] that we experienced in Q1 versus last year. There was -- the impact of pullbacks in Europe, was not impactful in Q1 of last year versus this year. So that's another key contributor to the erosion of the gross profit. And then the third component is really the strengthening of the euro versus the yen, given that we have more of our manufacturing plants and a lot of the OpEx is in euros for cost of goods. We are experiencing some of those headwinds there.

第二個是我們在第一季度與去年相比經歷的歐洲[回調]。歐洲經濟回調的影響，與今年相比，去年第一季度的影響並不大。因此，這是毛利潤下降的另一個關鍵因素。第三個組成部分實際上是歐元兌日元的走強，因為我們擁有更多的製造工廠，並且很多運營支出以歐元計算商品成本。我們在那裡遇到了一些阻力。

Having -- to your second part of the question on PDT, we are seeing in Q1 an improvement overall in PDT business, not only on the top line but also on the gross profit margin as well, given that the reduction in donor fees -- from last year, we did start to see a reduction in donor fees of anywhere between 10% to 15%. That's helping the improvement in the gross profit overall start to filter through the P&L this fiscal year, but not enough to offset the other components that I mentioned, mainly being the loss of exclusivity and the [pullbacks.] But overall, very pleased with the PDT performance. You saw in that, it's a key driver for growth in launch, growing at 24% at a constant exchange rate. And we're seeing really positive momentum on the gross profit and core operating profit lines.

關於 PDT 問題的第二部分，我們看到第一季度 PDT 業務整體有所改善，不僅在營收上，而且在毛利率上也有所改善，因為捐贈費用減少了——從去年開始，我們確實開始看到捐贈費用減少了10% 到15%。這有助於整體毛利潤的改善開始滲透到本財年的損益表中，但不足以抵消我提到的其他組成部分，主要是排他性的喪失和[回調]。但總的來說，我對PDT 性能。您可以看到，它是發布量增長的關鍵驅動力，按固定匯率計算增長了 24%。我們看到毛利潤和核心營業利潤線確實出現了積極的勢頭。

Wakao-san, it's Christophe here. I will add that we are pleased with the start. You asked whether it was -- how do we see this first quarter. For us, it's a good start of the year. It's a line or above our expectations. So let's see how things evolve for the remaining of the year, but a good start for sure.

若尾先生，我是克里斯托夫。我要補充一點，我們對這個開始感到滿意。您問我們如何看待第一季度。對我們來說，這是今年的良好開端。這是一條線或高於我們的預期。因此，讓我們看看今年剩下的時間裡事情會如何發展，但這肯定是一個好的開始。

Wakao-san, it's Andy. With respect to your question on the similarities and differences of 861 and 994. The 861 and 994 are distinct molecules. They have overlapping metabolic pathways. And so it's hard for us to know exactly whether 861 at a high enough dose would contain -- would have the same liver toxicity liabilities as 994. And so that's one of the reasons why we're proceeding with caution and limiting our dose to an empirical level where below which, across the industry, we just don't see liver toxicity. And as I think we all know, toxicity is always a function of dose, and this is particularly true for liver toxicity. Just to put this in context, the liver toxicity for 994 was seen at the 90-milligram BID dose. So it's a 180 milligrams per day of exposure. At the 30-milligram BID dose, 60 milligrams per day of exposure, we didn't see the liver toxicity. And if we were to make simplistic assumptions that there's a 1:1 equivalence, which I don't think is fair, we're targeting less than 10-milligram per day dose for 861. So we're looking at a 6- to 18-fold margin to where that potential toxicity is with 994.

若尾桑，我是安迪。關於861和994的異同問題。861和994是不同的分子。它們具有重疊的代謝途徑。因此，我們很難確切地知道 861 在足夠高的劑量下是否會含有與 994 相同的肝臟毒性。因此，這就是我們謹慎行事並將劑量限制在 994 的原因之一。經驗水平低於該水平，整個行業，我們就看不到肝毒性。我想我們都知道，毒性始終是劑量的函數，對於肝臟毒性尤其如此。就上下文而言，994 的肝臟毒性在 90 毫克 BID 劑量下可見。所以每天的接觸量為 180 毫克。在 30 毫克 BID 劑量（每天 60 毫克）的暴露劑量下，我們沒有看到肝臟毒性。如果我們簡單地假設存在 1:1 的等效性（我認為這是不公平的），那麼我們的目標是 861 每天的劑量低於 10 毫克。因此，我們正在考慮 6 至與994 的潛在毒性相比，有18 倍的餘量。

With respect to the backup programs, our next-generation programs, we've developed a very distinct pharmacophore or very distinct chemistry. So the series looks quite differently. They're entirely novel metabolic pathways [actually and pathways for illumination.] So the issue is -- (inaudible) out fully any potential issues, I would say, with the next-generation programs. And that's why -- why we spend so much time trying to rework some of the novelty in the space.

關於備份程序，我們的下一代程序，我們開發了一種非常獨特的藥效基團或非常獨特的化學物質。所以這個系列看起來完全不同。它們是完全新穎的代謝途徑（實際上是照明途徑）。所以問題是——（聽不清）完全消除任何潛在的問題，我想說，下一代程序。這就是為什麼——為什麼我們花這麼多時間試圖重新設計這個領域的一些新奇事物。

Thank you, thank you for your question. I'd like to take the next question from Hashiguchi-san from Daiwa.

謝謝你，謝謝你的提問。我想回答大和橋口先生的下一個問題。

[Interpreted] My question is on orexin agonist. Other than narcolepsy type 1, are there sleep disorders? What about the potential of orexin franchise indications other than narcolepsy type 1? Looking at New England Journal paper, regarding the dose demonstrating efficacy, it is low dose for narcolepsy type 1. But in other indications, sleep disorders may require a higher dose, that's discussed. And regarding symptoms, other than narcolepsy type 1 patients, there may be safety concern. That view was also described. And what is Takeda's view on this? And going forward, narcolepsy type 1 and others, what is your strategy going forward to develop for those different indications?

[解讀]我的問題是關於食慾素激動劑的。除了 1 型發作性睡病之外，還有睡眠障礙嗎？除了 1 型發作性睡病以外，食慾素專營適應症的潛力如何？看看《新英格蘭雜誌》的論文，關於證明療效的劑量，對於1 型發作性睡病來說是低劑量。但在其他適應症中，睡眠障礙可能需要更高的劑量，這是討論過的。至於症狀，除了 1 型嗜睡病患者外，可能還存在安全問題。也描述了這一觀點。武田對此有何看法？展望未來，1 型嗜睡症和其他疾病，您針對這些不同的適應症制定的策略是什麼？

Okay. So Andy, you got that? If you would like to provide an answer on that one, please?

好的。安迪，你明白了嗎？如果您願意對此提供答案，可以嗎？

Sure, Chris. Thank you, Hashiguchi-san. So we're actively developing TAK-861 in both narcolepsy type 1 and narcolepsy type 2, We'll be looking at the data from those studies later this year and making a decision as to whether we move forward in type 1 narcolepsy, type 1 plus type 2 plus additional indications or whether we limit our future development in type 1 narcolepsy. It's a very interested in a range of disorders, and the data that emerged from the Phase IIb study on 861 will inform on how broadly we intend to bring that molecule. And again, we're bringing additional molecules. We have TAK-925 for postoperative indications, and then we have our next-generation molecules, which we'll intend to develop more broadly as well.

當然，克里斯。謝謝你，橋口同學。因此，我們正在積極開發針對1 型嗜睡症和2 型嗜睡症的TAK-861，我們將在今年晚些時候查看這些研究的數據，並決定是否在1 型嗜睡症、1 型嗜睡症方面繼續前進。加上 2 型加上其他適應症，或者我們是否限制 1 型發作性睡病的未來發展。它對一系列疾病非常感興趣，861 IIb 期研究得出的數據將告訴我們我們打算在多大範圍內推廣該分子。我們再次帶來了額外的分子。我們有用於術後適應症的 TAK-925，然後我們有下一代分子，我們也打算更廣泛地開發它。

Thank you very much for the question. So next question, we'd like to invite Mike Nedelcovych from Cowen.

非常感謝你的提問。下一個問題，我們想邀請來自 Cowen 的 Mike Nedelcovych。

So my first question is from -- is on TAK-994. I was curious, the urinary urgency and urinary frequency AE was relatively prevalent. Are you seeing something similar with the next-generation agents? And is the dose reduction that's intended to address the active metabolite, is that also addressing to some extent the urinary urgency? That's my first question.

我的第一個問題是來自 TAK-994。我很好奇，尿急和尿頻AE是比較普遍的。您是否在下一代特工中看到類似的情況？減少劑量是否是為了解決活性代謝物的問題，是否也在一定程度上解決了尿急的問題？這是我的第一個問題。

And then my second question is on ENTYVIO. Do you anticipate a return to double-digit growth in the U.S.? And if so, do you have a general time frame over which you expect that to happen? And to what extent might this subcutaneous formulation contribute to that growth, if you expect it?

我的第二個問題是關於 ENTYVIO 的。您預計美國經濟將恢復兩位數增長嗎？如果是這樣，您是否有一個預計發生這種情況的大致時間範圍？如果您期望的話，這種皮下製劑會在多大程度上促進這種生長？

Thank you, Mike. So the first question on 994, the urinary urgency and whether we're seeing that with 861. I'd like to ask Andy to answer. And then the question on ENTYVIO potential return to double-digit growth, I'd like to ask Julie to comment on that.

謝謝你，邁克。所以關於 994 的第一個問題，尿急以及我們是否在 861 中看到了這種情況。我想請安迪回答。然後關於 ENTYVIO 是否有可能恢復兩位數增長的問題，我想請朱莉對此發表評論。

Mike, the urinary urgency appears to be on-target tolerability issue with the orexin 2 receptor agonist, not related, we think, to the -- any of the metabolites. Even though it's prevalent in a large percentage of patients, it seems to be fairly mild. And one of the indicators that makes us feel quite confident that this is going to be something that won't be a problem for these patients is that we see almost no dropouts in our studies, both for 994 and for the ongoing 861 study. And we see almost 100% conversion from the main trial to our open-label extensions.

邁克，尿急似乎是食慾素 2 受體激動劑的靶向耐受性問題，我們認為與任何代謝物無關。儘管它在很大一部分患者中普遍存在，但似乎相當輕微。讓我們非常有信心這對這些患者來說不會成為問題的指標之一是，我們在研究中幾乎沒有發現任何退出者，無論是 994 試驗還是正在進行的 861 試驗。我們看到從主要試驗到我們的開放標籤擴展的轉化率幾乎為 100%。

Mike, and in terms of ENTYVIO growth, I would say there are a few factors that we're looking at to have double-digit growth for ENTYVIO. First, as you heard Ramona say, we are anticipating approval and launch of ENTYVIO subcu in the U.S., and we do expect that to bring a lift to our growth. And then there are 2 other factors that we are working on. One is in terms of further evidence generation to support ENTYVIO. We have 3 planned studies in the U.S., 1 of which has already begun initiation in terms of work with our HCPs and clinical sites. And the second is in terms of leveraging data, digital and technology to further enhance our marketing capabilities to have more targeted and precise segments and marketing for ENTYVIO. So those are the 3 aspects that we are looking at to help drive ENTYVIO to double-digit growth this year.

邁克，就 ENTYVIO 的增長而言，我想說，我們正在考慮一些因素來使 ENTYVIO 實現兩位數的增長。首先，正如您聽到 Ramona 所說，我們預計 ENTYVIO subcu 將在美國獲得批准和推出，我們確實希望這將促進我們的增長。我們正在研究另外兩個因素。一是進一步生成支持 ENTYVIO 的證據。我們計劃在美國進行 3 項研究，其中 1 項已經開始與我們的 HCP 和臨床中心合作啟動。二是利用數據、數字化和科技進一步提升營銷能力，讓ENTYVIO的細分和營銷更有針對性、更精準。因此，我們希望從這三個方面推動 ENTYVIO 今年實現兩位數的增長。

Okay. Thank you, Mike. So the next question, I would like to call upon Muraoka-san from Morgan Stanley.

好的。謝謝你，邁克。那麼下一個問題，我想請摩根士丹利的村岡先生來回答。

[Interpreted] This is Muraoka, Morgan Stanley. Can you hear me okay -- can you hear me, this is Muraoka speaking?

[解說]我是摩根士丹利的村岡。你能聽到我說話嗎——你能聽到我說話嗎，我是村岡在說話嗎？

[Interpreted] Yes, we can.

[解釋] 是的，我們可以。

[Interpreted] Maybe I think it's too early to talk about the next fiscal year. But so far in this fiscal year, I think you are on track. And there are maybe some upside in your performance. That's my understanding. And the next fiscal year, no longer VYVANSE and ENTYVIO may take a little longer time to recover, then in the next fiscal year core operating profit, do you think it achieves positive growth? Or it may be flat or negative growth in 2 years running. Do we have to consider that possibility, that risk?

[解讀]也許我認為現在談論下一個財年還為時過早。但本財年到目前為止，我認為你們正在步入正軌。你的表現也許還有一些優點。這是我的理解。而下個財年，不再是VYVANSE和ENTYVIO可能需要更長一點的時間才能恢復，那麼下個財年的核心營業利潤，您認為會實現正增長嗎？或者可能連續兩年持平或負增長。我們是否必須考慮這種可能性、那種風險？

Okay. (inaudible) 2024, depending on VYVANSE and ENTYVIO, how they play out? Is the potential that 2024 could be a year of decline. So I'd like to ask Christophe perhaps to comment on this question.

好的。 （聽不清）2024 年，取決於 VYVANSE 和 ENTYVIO，他們的結局如何？ 2024 年有可能成為衰退的一年。所以我想請克里斯托夫對這個問題發表評論。

Thank you, Muraoka-san, well, it's way too early to give a guidance for the next fiscal year. I think the one key factor here will be the VYVANSE generic impact. We -- today, we plan for generic entry in August. You can imagine that if it will be delayed, for example, or if the number of generics would be lower or higher than what we have in our plan that (inaudible) will have an impact on the erosion curve. At the present time, our assumption is that we will rebounce in '24, '25 because we think that there will be much more limited impact of generic in '24, '25. But it's really important that we look at what happened this fiscal year in order to predict better how we rebounced. And if we rebounce as planned, it will be a rebounce on both the core operating profit on the revenue. But let's see, during the fiscal year '23 how things are evolving with both VYVANSE and AZILVA actually in order to predict better how we can see '24, '25 rebounce. Thank you.

謝謝村岡先生，現在給出下一財年的指導還為時過早。我認為這裡的一個關鍵因素是 VYVANSE 的一般影響。今天，我們計劃在八月進行通用輸入。您可以想像，例如，如果它被延遲，或者仿製藥的數量低於或高於我們計劃中的數量（聽不清），將對侵蝕曲線產生影響。目前，我們的假設是我們將在 24、25 年反彈，因為我們認為仿製藥在 24、25 年的影響將更加有限。但重要的是，我們必須了解本財年發生的情況，以便更好地預測我們的反彈情況。如果我們按計劃反彈，那麼這將是核心營業利潤和收入的反彈。但讓我們看看，在 23 財年，VYVANSE 和 AZILVA 的情況實際上是如何演變的，以便更好地預測我們如何看到 24、25 的反彈。謝謝。

Great. Thank you very much. Next question, I'd like to call upon Steve Barker of Jefferies.

偉大的。非常感謝。下一個問題，我想請傑富瑞 (Jefferies) 的史蒂夫·巴克 (Steve Barker) 發言。

Steve Barker from Jefferies. Two questions. One, about 861, I'd like to ask Andy about the choice of the 10-milligram dose. I understand the logic regarding wanting to reduce the risk of side effects. But given if you could explain what you're seeing in terms of the potency, and therefore, what you might theoretically expect to see in terms of the efficacy, some comments around that would be much appreciated.

來自傑富瑞集團的史蒂夫·巴克。兩個問題。一、關於861，我想請教Andy關於10毫克劑量的選擇。我理解想要降低副作用風險的邏輯。但如果你能解釋一下你所看到的效力，以及理論上你可能期望看到的功效，那麼對此的一些評論將不勝感激。

And then my second question is perhaps for Christophe, maybe Costa, Christophe, you mentioned in your comments that you would expect to see the core OPM get back up to low 30s -- low to mid-30s. And you mentioned that application of AI might be able to help efficiency. I'd actually be very interested to see -- to hear what -- how you think AI can be applied to the pharmaceutical business.

然後我的第二個問題也許是問 Christophe，也許是 Costa，Christophe，您在評論中提到您希望看到核心 OPM 回升至 30 多歲——低至 30 多歲。您提到人工智能的應用可能有助於提高效率。實際上，我非常有興趣了解——想听聽——你認為人工智能如何應用於製藥行業。

Okay. Steve. So I guess first question, Andy. And then maybe, Christophe, to start on that second question.

好的。史蒂夫.所以我猜第一個問題，安迪。克里斯托夫，然後也許可以開始第二個問題。

Steve, thank you very much. So firstly, 861 is a significantly more potent molecule when we look at the in vitro pharmacology relative to 994. It's also a molecule that has a more extended exposure and a longer half-life. So it's very different properties in TAK-994. So it's been important for us to look at the data that come out of our Phase IIb study to understand whether with our dose limit -- our dose cap, we can achieve the same level of efficacy as TAK-994. But intrinsically, the molecule has the potential to do that even at lower doses. And I'll add that we plan to begin sharing data from the 861 program in type 1 narcolepsy patients later this year. So some of the healthy volunteers see deprived data, some of the PK/PD modeling that we've used, those data will start to be out there in the coming months.

史蒂夫，非常感謝你。首先，當我們觀察體外藥理學時，861 是一種比 994 更有效的分子。它也是一種具有更長暴露時間和更長半衰期的分子。所以 TAK-994 的特性非常不同。因此，對我們來說，查看 IIb 期研究的數據非常重要，以了解在我們的劑量限制（劑量上限）下，我們是否可以達到與 TAK-994 相同的療效水平。但本質上，該分子即使在較低劑量下也有潛力做到這一點。我還要補充一點，我們計劃在今年晚些時候開始共享 861 計劃中 1 型發作性睡病患者的數據。因此，一些健康志願者看到了被剝奪的數據，我們使用的一些 PK/PD 模型，這些數據將在未來幾個月內開始公開。

Thank you, Steve, for the question. We see a very high potential for the utilization of AI in our business. But I will emphasize that is data, technology and AI. Without the data, you cannot train the AI. And without the technology, like image recognition, you don't have -- you don't generate data in many parts of our business. So we have been focusing on having data lake and data domain well structure in order to train the AI algorithm. And we are seeing application across our value chain. For example, in manufacturing, we are using image recognition on our manufacturing line in order to improve the efficiency of the line, for example.

謝謝你，史蒂夫，提出這個問題。我們看到人工智能在我們的業務中應用的巨大潛力。但我要強調的是數據、技術和人工智能。沒有數據，就無法訓練人工智能。如果沒有圖像識別等技術，您就無法在我們業務的許多部分生成數據。因此，我們一直專注於擁有數據湖和數據域良好的結構，以訓練人工智能算法。我們正在看到整個價值鏈的應用。例如，在製造業中，我們在生產線上使用圖像識別，以提高生產線的效率。

We are using AI as well to do some visual recognition that we have done manually in the past. So manufacturing side, we see a lot of productivity implication. On the research side, we are using AI for molecule design or for toxicity modernization, for example. We will use also the AI to accelerate clinical trials, test protocol, have higher patient activation. On the commercial side, we are looking at optimizing our interaction with doctors in a digital way, and we are using a algorithm as we speak already. On the data -- on the PDT side, for example, we are using some algorithm to have a better relationship with our donors. And so it's really across the board. And I didn't talk about back office, but we are also using this type of technology in our back office. In fact, we think that all our employees eventually will have some application of AI for their jobs. So this is really a very high priority for us. Thank you.

我們還使用人工智能來進行一些過去手動完成的視覺識別。因此，在製造方面，我們看到了很多生產力的影響。例如，在研究方面，我們正在使用人工智能進行分子設計或毒性現代化。我們還將使用人工智能來加速臨床試驗、測試方案，提高患者的激活率。在商業方面，我們正在考慮以數字方式優化我們與醫生的互動，並且我們正在使用我們已經說過的算法。在數據方面——例如，在 PDT 方面，我們正在使用某種算法來與捐贈者建立更好的關係。所以這確實是全面的。我沒有談論後台，但我們也在後台使用這種技術。事實上，我們認為我們所有的員工最終都會在工作中應用人工智能。所以這對我們來說確實是一個非常重要的優先事項。謝謝。

Thank you, Steve. And with that question, it brings us to the end of our time today. So thank you, everybody, for joining us on this conference call, and we look forward to talking with you again at a later date. Thank you, and good night.

謝謝你，史蒂夫。帶著這個問題，我們今天就結束了。感謝大家參加本次電話會議，我們期待稍後再次與您交談。謝謝，晚安。

[Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]

[本文字記錄中標記為[已翻譯]的部分是由現場通話中的口譯員朗讀的。]