Takeda Pharmaceutical Co Ltd (TAK) 2023 Q2 法說會逐字稿

[Interpreted] Thank you very much for taking time out of your busy schedule to join us today for Takeda's Financial Results Webinar for the Second Quarter of Fiscal Year 2022. My name is Ayako Iwamuro. I am in charge of IR. I will be your moderator today. Very nice to meet you.

[翻譯] 非常感謝您在百忙之中抽出時間參加今天的武田 2022 財年第二季度財務業績網絡研討會。我的名字是岩室綾子。我負責 IR。今天我來做你的主持人。很高興見到你。

First, let me explain the language settings. (Operator Instructions)

首先，讓我解釋一下語言設置。 （操作員說明）

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.

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大不相同。

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 Page 2 of the presentation material.

我們最近的 20-F 表格和我們提交給美國證券交易委員會的其他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。另請參閱演示材料第 2 頁的重要提示。

I would now like to turn to today's presentation. Let me introduce to you today's presenters. First, Christophe Weber, President and CEO; Andy Plump, President, R&D; Costa Saroukos, Chief Financial Officer. They will be giving the presentation. The presentation will be followed by a Q&A session. I would now like to begin.

我現在想談談今天的介紹。給大家介紹一下今天的主持人。首先，Christophe Weber，總裁兼首席執行官； Andy Plump，研發總裁；科斯塔薩魯科斯，首席財務官。他們將進行演示。演講之後將進行問答環節。我現在想開始。

Thank you very much, Ayako, and thank you, everyone, for joining us today. It's a really great pleasure to be with you.

非常感謝 Ayako，感謝大家今天加入我們。和你在一起真的很高興。

On the first slide, I would just summarize that Takeda, our vision is to discover and deliver a life-transforming treatment guided by our commitment to patient, our people and the planet. This is a purpose-led approach, which is at the core of our strategy for global growth and long-term value creation for our stakeholders.

在第一張幻燈片上，我只想總結一下武田，我們的願景是在我們對患者、我們的人民和地球的承諾的指導下，發現並提供一種改變生命的治療方法。這是一種以目標為導向的方法，是我們為利益相關者實現全球增長和長期價值創造戰略的核心。

Our performance in the first half of the fiscal year further demonstrate our progress in executing on that strategy as we look to accelerate growth, advance our pipeline and deliver on our commitment.

我們在本財年上半年的表現進一步證明了我們在執行該戰略方面取得的進展，因為我們希望加快增長、推進我們的管道並兌現我們的承諾。

I will move to Slide 5. If someone can move the slide. Yes, thank you.

我將移至幻燈片 5。如果有人可以移動幻燈片。是的，謝謝。

On Slide 5, I would like to take you through some of the recent highlights. In the first 6 months, our core revenue was JPY 1,974.8 billion, which represents a 5.5% growth at a constant exchange rate.

在幻燈片 5 上，我想帶您了解最近的一些亮點。前 6 個月，我們的核心收入為 19,748 億日元，按固定匯率計算增長 5.5%。

Core operating profit for the period was JPY 625.2 billion, growing at an impressive 14.5%, also on a constant exchange rate basis. This enabled us to deliver a strong core operating profit margin of 31.7%, an improvement of 2.4 percentage points versus prior year. And core earnings per share was JPY 288 with growth of 15.8% at -- again, at constant exchange rates.

該期間的核心營業利潤為 6,252 億日元，以驚人的 14.5% 增長，同樣按固定匯率計算。這使我們能夠實現 31.7% 的強勁核心營業利潤率，比上年提高 2.4 個百分點。每股核心收益為 288 日元，增長 15.8%，同樣按固定匯率計算。

Based on these strong results, we are reconfirming the full year management guidance for low single-digit core revenue growth and high single-digit core operating profit and core EPS growth. These are all at constant exchange rates.

基於這些強勁的業績，我們正在重新確認低個位數核心收入增長和高個位數核心營業利潤和核心每股收益增長的全年管理指導。這些都是固定匯率。

On a reported basis, our strong business performance coupled with foreign exchange tailwinds enabled us to deliver reported revenue growth of 10.1%. And that is despite a large gain of JPY 133 billion, we booked as revenue in the first quarter of the last year related to the sale of the diabetes portfolio in Japan.

在報告的基礎上，我們強勁的業務表現加上外匯順風使我們能夠實現 10.1% 的報告收入增長。儘管獲得了 1,330 億日元的巨額收益，但我們在去年第一季度將與在日本出售糖尿病產品組合相關的收入計入了收入。

Our business momentum remained strong and the significant upside we are seeing from foreign exchange has led us to raise our reported and core forecast and free cash flow outlook for the full year. Costa will share further details on this.

我們的業務勢頭依然強勁，我們從外匯中看到的顯著上漲促使我們上調了全年的報告和核心預測以及自由現金流前景。 Costa 將分享這方面的更多細節。

The revenue growth in the first half of the year was driven by our growth and launch products, which delivered strong performance across our key business areas and grew 19% year-on-year at constant exchange rate.

上半年的收入增長受我們的增長和推出產品的推動，在我們的主要業務領域取得了強勁的表現，按固定匯率計算同比增長 19%。

ENTYVIO, TAKHZYRO and Immunoglobulin each recorded double-digit growth of 17%, 31% and 17%, respectively, in the first half of the fiscal year. And we saw continued launch momentum from EXKIVITY and LIVTENCITY, demonstrating the strength of our commercial execution.

ENTYVIO、TAKHZYRO 和 Immunoglobulin 在本財年上半年分別錄得 17%、31% 和 17% 的兩位數增長。我們看到 EXKIVITY 和 LIVTENCITY 的持續發布勢頭，展示了我們商業執行的實力。

We continue to see potential for further market growth and share expansion for ENTYVIO, and we are raising our peak sales estimate to a new range of USD 7.5 billion to USD 9 billion. I will discuss this in more details in a moment.

我們繼續看到 ENTYVIO 進一步市場增長和份額擴張的潛力，我們將最高銷售額估計提高到 75 億美元至 90 億美元的新範圍。稍後我將更詳細地討論這個問題。

Earlier this month, we achieved a significant pipeline milestone when the CHMP recommended approval of our dengue vaccines candidate, TAK-003, for prevention of dengue disease. This came just 2 months after our vaccines first approval in Indonesia. I will discuss QDENGA further on the next slide.

本月早些時候，當 CHMP 建議批准我們的登革熱候選疫苗 TAK-003 用於預防登革熱時，我們實現了一個重要的管道里程碑。這距離我們的疫苗在印度尼西亞首次獲批僅 2 個月。我將在下一張幻燈片上進一步討論 QDENGA。

We also received a positive CHMP opinion for maribavir in relapse and refractory cytomegalovirus disease after transplant. In both cases, we expect the European Commission to decide upon marketing authorization in the coming months.

我們還收到了 CHMP 對 maribavir 在移植後復發和難治性鉅細胞病毒病中的積極意見。在這兩種情況下，我們預計歐盟委員會將在未來幾個月內決定上市許可。

And most recently, we entered into a collaboration and licensing agreement with Zedira and Dr. Falk Pharma to develop TAK-227 for the treatment of celiac disease, an area of significant unmet need for patients.

最近，我們與 Zedira 和 Falk Pharma 博士簽訂了合作和許可協議，以開發 TAK-227用於治療乳糜瀉，這是患者未滿足的重大需求領域。

I would like now to focus on our dengue vaccines. The CHMP positive opinion for TAK-003 marked a major moment for Europe and the dengue of any countries that participated in the EU medicine for all procedures. But it's also a critical moment for the global health community.

我現在想專注於我們的登革熱疫苗。 CHMP 對 TAK-003 的積極意見標誌著歐洲和任何參與歐盟醫學所有程序的國家的登革熱的重要時刻。但這也是全球衛生界的關鍵時刻。

Severe dengue is a leading cause of serious illness and death among children and adults in Latin America and Asia. And the impact of dengue goes beyond just those who are infected. There is often a significant economic burden on families supporting an hospitalized family member and an outbreak of dengue can overhelm hospitals, causing a restriction in access to health care.

重症登革熱是拉丁美洲和亞洲兒童和成人嚴重疾病和死亡的主要原因。登革熱的影響不僅限於感染者。支持住院家庭成員的家庭通常會承受巨大的經濟負擔，而登革熱的爆發可能會使醫院不堪重負，從而導致獲得醫療保健的機會受到限制。

The incidence of dengue has grown dramatically in recent decades, causing an estimated 390 million infection and 0.5 million hospitalization annually. Over half of the world population is at risk. According to the WHO, we have identified dengue as a top 10 threat to global health.

近幾十年來，登革熱的發病率急劇上升，估計每年造成 3.9 億人感染和 50 萬人住院。世界上超過一半的人口處於危險之中。據世界衛生組織稱，我們已將登革熱確定為對全球健康的十大威脅。

Among the factors driving this rise in prevalence, the most critical ones are urbanization, globalization and climate change. All-in-all, this speaks to the urgent need for a safe and effective vaccine for the prevention of dengue disease. So with the approval in Indonesia and if approved by the European Commission, QDENGA will be a critical addition to the limited set of tools available to prevent dengue.

在推動患病率上升的因素中，最關鍵的因素是城市化、全球化和氣候變化。總而言之，這說明迫切需要一種安全有效的疫苗來預防登革熱。因此，隨著印度尼西亞的批准以及歐盟委員會的批准，QDENGA 將成為可用於預防登革熱的有限工具集的重要補充。

The reason from our Phase III clinical trial demonstrated long-term protection against dengue fever through 4.5 years with the vaccines preventing 84% of hospitalized dengue cases and reducing cases of symptomatic dengue by 61% overall with no important safety risk identified to date.

我們的 III 期臨床試驗的原因表明，疫苗可在 4.5 年內對登革熱提供長期保護，預防 84% 的住院登革熱病例，並將有症狀的登革熱病例總體減少 61%，迄今為止未發現重要的安全風險。

The positive CHMP opinion is particularly encouraging because this is also the European Medicines Agency first-ever parallel assessment of a medicinal product for use in countries outside the EU, all 8 of which are dengue-endemic.

CHMP 的積極意見特別令人鼓舞，因為這也是歐洲藥品管理局首次對用於歐盟以外國家的藥品進行平行評估，所有 8 個國家都是登革熱流行的。

What's very important here is that the CHMP recommended approval for broad use regardless of prior dengue exposure, which will make QDENGA the only dengue vaccines that does not require a blood test before administration, which we see as eliminating a critical barrier to access and increasing confidence about the efficacy and safety of the vaccines. As I said, we expect the European Commission to make a decision on approval in the coming months with the dengue-endemic countries to follow.

這裡非常重要的是，CHMP 建議批准廣泛使用，無論之前是否接觸過登革熱，這將使 QDENGA 成為唯一不需要在給藥前進行血液檢查的登革熱疫苗，我們認為這消除了獲取的關鍵障礙並增加了信心關於疫苗的有效性和安全性。正如我所說，我們預計歐盟委員會將在未來幾個月內做出批准決定，登革熱流行國家隨後會跟進。

Besides Europe, we received our first approval in Indonesia in August and expect to launch QDENGA in early 2023. More filings are to come with the U.S. filing expected within fiscal year 2022. In December, we will hold an investor event to dive deeper into our commercial strategy for this exciting vaccine.

除歐洲外，我們於 8 月在印度尼西亞獲得了首次批准，預計將於 2023 年初推出 QDENGA。預計在 2022 財年向美國提交更多申請。12 月，我們將舉辦投資者活動以深入了解我們的這種令人興奮的疫苗的商業戰略。

Moving to ENTYVIO, for which we are raising our peak sales outlook to $7.5 billion to $9 billion from the previous estimate of $5.5 billion to $6.5 billion. Since its launch in 2014, ENTYVIO has delivered outstanding growth momentum, and we are on track to exceed $5 billion in revenue this fiscal year. ENTYVIO has established itself as a leading treatment option for IBD and is currently the #1 prescribed biologic in bio-naïve patients.

轉向 ENTYVIO，我們正在將我們的峰值銷售前景從之前估計的 55 億美元到 65 億美元提高到 75 億美元到 90 億美元。自 2014 年推出以來，ENTYVIO 實現了出色的增長勢頭，我們有望在本財年實現超過 50 億美元的收入。 ENTYVIO 已將自己確立為 IBD 的領先治療選擇，目前是未接受過生物治療的患者中排名第一的處方生物製劑。

Our confidence in raising peak sales reflect the continued expansion of the biologic market and in a number of other factors related to the product. First, ENTYVIO has a depth of clinical data on real-world experience, demonstrating its efficacy and safety, while we do expect there to be an increasing competition in IBD. We have yet to see any other product demonstrating superiority of our existing biologic therapies.

我們對提高銷售峰值的信心反映了生物市場的持續擴張以及與產品相關的許多其他因素。首先，ENTYVIO 擁有豐富的真實世界經驗臨床數據，證明了其有效性和安全性，而我們確實預計 IBD 領域的競爭會越來越激烈。我們還沒有看到任何其他產品證明我們現有的生物療法的優越性。

Second, ENTYVIO also continues to gain total patient share in various regions and potential share gain are far from exhausted. As you can see from the chart, we continue to see an upward trend in market share in key regions.

其次，ENTYVIO 還在各個地區繼續獲得總患者份額，並且潛在的份額收益遠未耗盡。從圖表中可以看出，我們繼續看到關鍵地區的市場份額呈上升趨勢。

In addition, we remain on track to file a subcutaneous formulation in the U.S. in fiscal year 2023, opening another pathway for growth. We will also continue to invest in further evidence generation to maximize the potential of the product.

此外，我們仍有望在 2023 財年在美國提交皮下製劑，開闢另一條增長途徑。我們還將繼續投資於進一步的證據生成，以最大限度地發揮產品的潛力。

Finally, as we share -- as we have shared previously, we have significantly extended our base case timeline for when biosimilar are likely to be launched. At this stage, it is highly unlikely that we will see a biosimilar launch this decade, and it could be as late as 2032.

最後，正如我們所分享的——正如我們之前所分享的，我們已經大大延長了我們的基本案例時間表，以確定何時可能推出生物仿製藥。在現階段，我們極不可能在這十年內看到生物仿製藥的推出，而且可能最晚到 2032 年。

So 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.

因此，最後，本季度表明我們的增長戰略仍處於正軌。我們將繼續履行我們的財務承諾，以推進我們的管道並為我們的利益相關者創造長期價值，同時我們實現為人們帶來更好的健康和為世界帶來更光明未來的目標。

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

有了這個，我會把電話轉給安迪，讓你了解我們的管道。謝謝你。

Thank you, Christophe, and hello to everybody on the call today. If we can go to the next Slide 10, please, Chris. As Christophe just mentioned, we are extremely excited about the positive CHMP opinion supporting the broad use of QDENGA. We believe QDENGA is a transformative vaccine, fills a substantial unmet medical need for individuals in and, of course, travelers to warm weather climates.

謝謝你，克里斯托夫，向今天電話會議的每個人問好。如果我們可以轉到下一張幻燈片 10，請克里斯。正如 Christophe 剛剛提到的，我們對 CHMP 的積極意見支持廣泛使用 QDENGA 感到非常興奮。我們相信 QDENGA 是一種變革性的疫苗，可以滿足人們在溫暖氣候中的大量未滿足的醫療需求，當然還有旅行者。

According to the World Health Organization, dengue is a top global threat that causes an estimated 500,000 hospitalizations each year. QDENGA has the potential to prevent morbidity and mortality from dengue in endemic regions around the world. And as we've learned from COVID, a vaccine that protects against viral outbreaks and hospitalizations may also prevent local health care systems from being overwhelmed and unable to provide routine care.

據世界衛生組織稱，登革熱是全球最大的威脅，每年估計有 500,000 人住院。 QDENGA 有可能在世界各地的流行地區預防登革熱的發病率和死亡率。正如我們從 COVID 中了解到的那樣，一種可以防止病毒爆發和住院的疫苗也可以防止當地的醫療保健系統不堪重負而無法提供常規護理。

This potential approval is the culmination of more than 10 years of successful research and development to produce a safe and effective vaccine against the dengue virus. And after many years of thoughtful development, we were able to show an 84% reduction in hospitalization and no harmful effects 4.5 years after vaccination.

這一潛在的批准是 10 多年成功研發的成果，旨在生產一種安全有效的登革熱病毒疫苗。經過多年深思熟慮的發展，我們在接種疫苗 4.5 年後，住院率降低了 84%，並且沒有任何有害影響。

Moving to LIVTENCITY, which was approved in Canada and Australia for second-line post-transplant CMV disease this quarter. As Christophe just mentioned, we also received a positive CHMP opinion in September. We're looking forward to the near-term approval and launch in the EU.

轉移到 LIVTENCITY，該公司本季度在加拿大和澳大利亞獲批用於移植後 CMV 疾病的二線治療。正如 Christophe 剛剛提到的，我們在 9 月也收到了 CHMP 的正面意見。我們期待近期的批准並在歐盟推出。

TAKHZYRO was filed in the U.S. for the prevention of HAE attacks in children 2 to 12 years of age. If approved, it would be the first and only prophylaxis treatment available for patients younger than 6 years of age.

TAKHZYRO 在美國被提交用於預防 2 至 12 歲兒童的 HAE 發作。如果獲得批准，這將是第一個也是唯一一個可用於 6 歲以下患者的預防性治療。

We have one new clinical start this quarter for TAK-920, an antibody treatment for Alzheimer's disease targeting TREM2. This is the second experimental therapy to enter clinical development using Denali's blood-brain barrier transport vehicle-enabled technology.

TAK-920 是一種針對 TREM2 的阿爾茨海默病抗體治療藥物，本季度我們有一個新的臨床開始。這是使用 Denali 的血腦屏障運輸車輛技術進入臨床開發的第二個實驗療法。

And lastly, we signed a licensing agreement with Dr. Falk Pharma and Zedira for TAK-227 in the U.S. and other territories outside of EU, CAN, Australia and China.

最後，我們與 Dr. Falk Pharma 和 Zedira 簽署了 TAK-227在美國和歐盟、加拿大、澳大利亞和中國以外的其他地區的許可協議。

TAK-227 is an oral tissue, TG2 or transglutaminase 2 inhibitor with enriched activity in the intestines. The TG2 enzyme generates immunogenic gluten peptide fragrance following the breakdown of gluten in the stomach and intestines. By inhibiting the body's immune response to gluten, it has been demonstrated to prevent mucosal damage in the small intestines.

TAK-227 是一種口腔組織、TG2 或轉谷氨酰胺酶 2 抑製劑，在腸道中具有豐富的活性。 TG2 酶在谷蛋白在胃和腸中分解後產生免疫原性谷蛋白肽香味。通過抑制身體對麩質的免疫反應，它已被證明可以防止小腸的粘膜損傷。

A Phase IIa proof-of-concept study published in the New England Journal of Medicine demonstrated a protective effect of TAK-227 in patients undergoing a 6-week gluten challenge.

發表在《新英格蘭醫學雜誌》上的一項 IIa 期概念驗證研究證明了 TAK-227 對接受 6 週麵筋挑戰的患者俱有保護作用。

TAK-227 showed very significant protective effects on the ratio of villous height to crypt depth in the duodenal mucosa. Widely considered to be the most objective and valid endpoint in clinical studies for celiac disease. The trial also showed favorable effects of TAK-227 on a number of patient reported outcomes. The program is currently in a Phase IIb trial, testing 3 different doses and 2 dosing schedules over a 12-week period in celiac patients, including free diet.

TAK-227對十二指腸黏膜絨毛高度與隱窩深度的比值顯示出非常顯著的保護作用。被廣泛認為是乳糜瀉臨床研究中最客觀和有效的終點。該試驗還顯示了 TAK-227 對許多患者報告的結果的有利影響。該計劃目前處於 IIb 期試驗中，在 12 週內對乳糜瀉患者測試 3 種不同劑量和 2 種給藥方案，包括免費飲食。

This agreement to bring a Phase IIb program with strong early data into our pipeline, complementing our portfolio of potential best-in-class therapies for moderate to severe celiac disease. Other programs include the potent short-acting oral glutenase TAK-062 with potential for mealtime dosing and the systemically administered immune tolerizing nanoparticle, TAK-101.

該協議將具有強大早期數據的 IIb 期項目引入我們的管道，補充我們潛在的中度至重度乳糜瀉的一流療法組合。其他項目包括有效的短效口服麩質酶 TAK-062，具有進餐時間給藥的潛力，以及全身給藥的免疫耐受納米顆粒 TAK-101。

So let me tell you a little bit about celiac disease. It has a global presence of about 1% of the population and no approved therapies, maintaining a strict lifelong gluten-free diet is highly burdensome. And even with dietary modification, many patients continue to have persistent symptoms, small intestinal mucosal injury and the potential for very severe secondary consequences, including malnutrition, cancer, diabetes and even a higher mortality rate.

所以讓我告訴你一些關於乳糜瀉的事情。它在全球約有 1% 的人口存在，並且沒有批准的療法，因此維持嚴格的終生無麩質飲食是非常繁重的。即使通過飲食調整，許多患者仍然有持續的症狀、小腸黏膜損傷和非常嚴重的繼發性後果，包括營養不良、癌症、糖尿病，甚至更高的死亡率。

If proven safe and effective, these investigational therapies have the potential to substantially benefit patients who continue to suffer from celiac disease despite dietary intervention.

如果被證明是安全有效的，這些研究性療法有可能使儘管飲食干預仍繼續患有乳糜瀉的患者受益。

If we can move to Slide 11, please.

如果我們可以轉到幻燈片 11，請。

Shown here are 10 late-stage development programs, which continue to advance. As mentioned, we received a positive CHMP opinion for LIVTENCITY in second-line CMV disease, and a positive CHP opinion for QDENGA as part of the EU medicines for all process.

這裡顯示的是 10 個後期開發計劃，它們會繼續推進。如前所述，我們收到了 CHMP 對 LIVTENCITY 二線 CMV 疾病的積極意見，以及 QDENGA 作為所有過程的歐盟藥物的一部分的積極 CHP 意見。

We're on track to start a Phase III trial for fazirsiran, or TAK-999 by the end of our fiscal year. And we continue to search externally for programs within our therapeutic areas and strategic focus that can add to our late-stage development pipeline and contribute to our marketed portfolio this decade.

我們有望在本財年末開始對 fazirsiran 或 TAK-999 進行 III 期試驗。我們繼續在外部尋找我們治療領域和戰略重點內的項目，這些項目可以增加我們的後期開發管道，並為我們這十年的營銷組合做出貢獻。

Next slide, please, Chris. We continue to be excited about our proof-of-concept readouts to come over the next 1 to 2 years. We plan to share updates on several of these programs, including TAK-861, the oral orexin 2 receptor agonist by the end of the fiscal year. These are the first of many new molecular entities that could emerge from our rich and transformative early-stage pipeline and add to our growing late-stage development programs.

請下一張幻燈片，克里斯。我們繼續對未來 1 到 2 年的概念驗證讀數感到興奮。我們計劃在本財年末分享其中幾個項目的更新，包括 TAK-861，口服食慾素 2 受體激動劑。這些是許多新分子實體中的第一個，它們可以從我們豐富且具有變革性的早期管道中出現，並添加到我們不斷增長的後期開發計劃中。

Next slide, please. Shown here are select expansion opportunities we have for our major brands. We completed filing for TAKHZYRO for the prevention of hereditary angioedema in children based upon the outstanding data presented from the SPRING study at the European Academy of Allergy and Clinical Immunology this past summer. These data continue to illustrate the best-in-class efficacy and safety profile of TAKHZYRO, demonstrating 95% reductions in HAE attacks.

請下一張幻燈片。此處顯示的是我們為主要品牌提供的精選擴張機會。根據去年夏天歐洲過敏和臨床免疫學會 SPRING 研究提供的出色數據，我們完成了 TAKHZYRO 預防兒童遺傳性血管性水腫的申請。這些數據繼續說明 TAKHZYRO 同類最佳的療效和安全性，表明 HAE 發作減少了 95%。

We also filed CUVITRU for primary and secondary immune deficiency in Japan, continuing the product's global expansion. And we are on track to soon file HYQVIA in the U.S. and EU as maintenance therapy for patients with CIDP based upon the positive results announced last quarter.

我們還在日本為原發性和繼發性免疫缺陷申請了 CUVITRU，繼續產品的全球擴張。根據上季度公佈的積極結果，我們有望很快在美國和歐盟提交 HYQVIA 作為 CIDP 患者的維持治療。

If we can go to the next slide and my last slide, please. We have several key regulatory decisions and Phase III study readouts expected this year. This quarter, QDENGA was approved in Indonesia with a broad label. We also received a positive CHMP opinion recommending a broad label in the EU and in dengue-endemic countries participating in the parallel EU medicines for all procedure.

請轉到下一張幻燈片和我的最後一張幻燈片。我們預計今年會有幾項關鍵的監管決定和 III 期研究結果。本季度，QDENGA 在印度尼西亞獲得了廣泛的批准。我們還收到了積極的 CHMP 意見，建議在歐盟和登革熱流行國家為所有程序參與平行的歐盟藥物。

We look forward to an EU decision in the coming months and additional regulatory reviews in dengue-endemic countries in Latin America and Asia. We are on track to release the additional Phase III readouts later this fiscal year.

我們期待歐盟在未來幾個月做出決定，並期待拉丁美洲和亞洲登革熱流行國家的額外監管審查。我們有望在本財年晚些時候發布額外的第三階段讀數。

Thank you all very much, and I will now turn it over to Costa. Costa?

非常感謝大家，我現在把它交給 Costa。科斯塔？

Thank you, Andy, and hello, everyone. This is Costa Saroukos speaking. Today, I would like to walk you through Takeda's fiscal 2022 first half financial highlights. But before that, I'd like to make a couple of high-level comments on our financial resilience in the current macro environment.

謝謝你，安迪，大家好。這是科斯塔薩魯科斯說話。今天，我想帶您了解武田 2022 財年上半年的財務亮點。但在此之前，我想對我們在當前宏觀環境下的財務彈性發表一些高層評論。

Firstly, we have been delivering on our growth strategy. And our Growth & Launch Products maintained strong momentum that we expect to carry on through the entry of VYVANSE generics next year and beyond. And as Christophe detailed earlier, we are increasing our peak sales forecast for ENTYVIO to USD 7.5 billion to USD 9 billion.

首先，我們一直在實施我們的增長戰略。我們的增長和推出產品保持強勁勢頭，我們預計將通過 VYVANSE 仿製藥明年及以後的進入繼續保持這種勢頭。正如 Christophe 之前詳述的那樣，我們將 ENTYVIO 的最高銷售額預測提高到 75 億美元至 90 億美元。

Next, we delivered year-over-year core margin improvement of over 2 percentage points despite the inflationary environment and despite emergence of VELCADE generics in May this year.

接下來，儘管通貨膨脹環境和今年 5 月出現了 VELCADE 仿製藥，我們仍實現了超過 2 個百分點的核心利潤率同比增長。

We have strong liquidity, and we have already locked in 98% of our debt at fixed rates with a weighted average interest rate of 2%. And in fact, we'll pay off the final portion of floating debt in November. So by next month, we will be at 100% fixed rates, meaning we are in a very favorable position within the current environment of increasing interest rates.

我們擁有強大的流動性，我們已經以 2% 的加權平均利率鎖定了 98% 的固定利率債務。事實上，我們將在 11 月還清浮動債務的最後一部分。因此，到下個月，我們將達到 100% 的固定利率，這意味著我們在當前利率上升的環境中處於非常有利的位置。

Finally, FX has been a significant tailwind for Takeda this year, and we are upgrading our guidance to reflect this. I'll go through the details of this shortly.

最後，外匯今年對武田來說是一個重要的推動因素，我們正在升級我們的指導以反映這一點。稍後我將詳細介紹這一點。

Now turning to Slide 16 and the financial highlights for the first half. Core revenue continues to deliver strong growth, up 5.5% versus prior year at constant exchange rate. This was driven by Growth & Launch Products such as ENTYVIO, TAKHZYRO and Immunoglobulin as we delivered growth in all geographic regions. We also continued to see steady uptake from the recent launches of LIVTENCITY and EXKIVITY in the U.S.

現在轉向幻燈片 16 和上半年的財務亮點。核心收入繼續實現強勁增長，按固定匯率計算，同比增長 5.5%。這是由 ENTYVIO、TAKHZYRO 和免疫球蛋白等增長和推出產品推動的，因為我們在所有地理區域都實現了增長。我們還繼續看到最近在美國推出的 LIVTENCITY 和 EXKIVITY 的穩步增長。

Reported revenue growth was 10.1% with business momentum and FX more than offsetting the impact of a JPY 133 billion gain from the sale of the Japan diabetes business that was booked in Q1 of the prior year. This one-time event is the only difference between reported and core revenue growth rates.

報告的收入增長為 10.1%，業務增長勢頭和外匯抵消了去年第一季度出售日本糖尿病業務帶來的 1,330 億日元收益的影響。這一一次性事件是報告和核心收入增長率之間的唯一區別。

The gain from the portfolio sale is also the main reason that reported operating profit for H1 declined on a year-on-year basis. Core operating profit, which excludes this gain, grew at 14.5% at a constant exchange rate to JPY 625.2 billion. Our core operating profit margin was 31.7%, an increase of 2.4 percentage points on a year-over-year basis. This year-on-year margin boost is an indicator of our financial resilience and our ability to control costs. In fact, at constant exchange rate, our SG&A spend declined versus prior year.

組合出售的收益也是上半年報告的營業利潤同比下降的主要原因。扣除這一收益的核心營業利潤按固定匯率增長 14.5% 至 6,252 億日元。我們的核心營業利潤率為31.7%，同比增長2.4個百分點。利潤率同比增長是我們財務彈性和控製成本能力的一個指標。事實上，按固定匯率計算，我們的 SG&A 支出與去年相比有所下降。

Net debt to adjusted EBITDA came down to 2.6x from 2.8x at the end of Q1, which means we are getting very close to our target of low 2s. With regard to the full year guidance, we are reconfirming our constant exchange rate growth guidance while upgrading our reported and core and cash flow forecast, primarily due to FX tailwind.

調整後 EBITDA 的淨債務從第一季度末的 2.8 倍降至 2.6 倍，這意味著我們非常接近我們的低 2 倍目標。關於全年指引，我們正在重新確認我們的恆定匯率增長指引，同時上調我們報告的核心和現金流預測，主要是由於外匯順風。

Slide 17 shows our first half results in more detail. On the left-hand side, you can see the impact of the sale of the Japan diabetes portfolio in last year on our reported growth rates as well as our cash flow. The impact of this one-time event on our growth rates will unwind over the rest of the year. And for the full year, we are expecting double-digit reported operating profit and reported EPS growth.

幻燈片 17 更詳細地顯示了我們上半年的結果。在左側，您可以看到去年出售日本糖尿病產品組合對我們報告的增長率和現金流的影響。這一一次性事件對我們增長率的影響將在今年剩餘時間裡逐漸減弱。對於全年，我們預計報告的營業利潤和報告的每股收益將實現兩位數的增長。

Focusing on the core numbers on the right, I'm very pleased with the H1 growth we are delivering on a constant exchange rate basis with revenue up 5.5%, core operating profit up 14.5% and core EPS growth of 15.8%. In addition, foreign exchange has been a significant tailwind for us year-to-date, resulting in actual core EPS growth of close to 35%.

關注右側的核心數據，我對我們在固定匯率基礎上實現的上半年增長感到非常滿意，收入增長 5.5%，核心營業利潤增長 14.5%，核心每股收益增長 15.8%。此外，今年迄今為止，外匯對我們來說是一個重要的推動因素，導致實際核心每股收益增長接近 35%。

Let me go into more detail on the H1 revenue performance versus prior year on Slide 18. On the left is a waterfall chart for reported revenue, which grew at 10.1% year-on-year, with business momentum and for foreign exchange favorability more than offsetting the full impact of the JPY 133 billion one-off we booked in Q1 of last year from the sale of Japan diabetes portfolio.

讓我在幻燈片 18 上更詳細地了解 H1 收入表現與上一年的對比。左邊是報告收入的瀑布圖，同比增長 10.1%，業務勢頭和外匯優惠超過抵消了我們在去年第一季度從出售日本糖尿病產品組合中獲得的一次性 1,330 億日元的全部影響。

Core revenue on the right-hand side excludes the impact of the diabetes portfolio sale. And as you can see, our business momentum was driving 5.5% growth at constant exchange rate, with the additional foreign exchange tailwind driving total core revenue growth of 18.9%.

右側的核心收入不包括糖尿病組合銷售的影響。如您所見，我們的業務動力以固定匯率推動增長 5.5%，額外的外匯順風推動總核心收入增長 18.9%。

On Slide 19, you can see that the key driver of top line growth is our portfolio of Growth & Launch Products, which generated JPY 759.8 billion, or 38.5% of total revenue in H1 with 19% growth at constant exchange rate. Incrementally, these products added JPY 205 billion or USD 1.4 billion of revenue compared to the first half of last year.

在幻燈片 19 上，您可以看到收入增長的主要驅動力是我們的增長和發布產品組合，該產品組合在上半年產生了 7598 億日元，佔總收入的 38.5%，按固定匯率計算增長 19%。與去年上半年相比，這些產品增加了 2050 億日元或 14 億美元的收入。

Within our 5 key business areas, GI, our largest area by revenue grew at 12% year-to-date on a constant exchange rate basis. This was spearheaded by ENTYVIO, which grew at 17%, driven by a continued increase in bio-naïve patient share. In rare diseases, which grew at 8%, we see continued demand growth and geographic expansion for TAKHZYRO, which delivered growth of 31%. We also see early indicators of success with the LIVTENCITY launch, with 75% of transplant centers in the U.S., having now initiated therapy with at least 1 patient.

在我們的 5 個主要業務領域 GI 中，按固定匯率計算，我們最大的收入領域今年迄今增長了 12%。這由 ENTYVIO 帶頭，增長了 17%，這得益於生物初始患者份額的持續增加。在增長 8% 的罕見疾病中，我們看到 TAKHZYRO 的需求持續增長和地域擴張，實現了 31% 的增長。我們還看到 LIVTENCITY 推出的早期成功指標，美國 75% 的移植中心現已開始對至少 1 名患者進行治療。

PDT Immunology continues to be very strong with 14% growth, including 17% growth of Immunoglobulin fueled by strong global demand and enabled by steady supply. We have continued to expand our donation center network, adding 16 centers in the last 6 months, and we are on track to our guidance of 10% to 20% increase in plasma donation volumes for the full year. We are also managing costs to improve margins over time. And average donor compensation in the U.S. is down by over 15% compared to the first half of fiscal 2021.

PDT Immunology 繼續保持強勁增長，增長 14%，其中免疫球蛋白增長 17%，這得益於強勁的全球需求和穩定的供應。我們繼續擴大我們的捐贈中心網絡，在過去 6 個月中增加了 16 個中心，我們有望實現全年血漿捐贈量增加 10% 至 20% 的指導。我們還在管理成本，以隨著時間的推移提高利潤率。與 2021 財年上半年相比，美國的平均捐助者薪酬下降了 15% 以上。

Next, in Oncology, which is declining year-on-year as expected, given that VELCADE generics entered the U.S. market from May this year. Excluding VELCADE, the rest of the portfolio grew at 6%, driven by ALUNBRIG, EXKIVITY, ADCETRIS and ICLUSIG.

接下來，在腫瘤學方面，由於 VELCADE 仿製藥從今年 5 月開始進入美國市場，因此同比下降。不包括 VELCADE，在 ALUNBRIG、EXKIVITY、ADCETRIS 和 ICLUSIG 的推動下，其餘投資組合增長了 6%。

Finally, Neuroscience continues to perform very well with growth of 11%, driven by VYVANSE and TRINTELLIX, while the other segment is declining due to some regional loss of exclusivities in Japan.

最後，在 VYVANSE 和 TRINTELLIX 的推動下，神經科學繼續表現良好，增長了 11%，而其他部分則由於日本的一些地區獨家性損失而下降。

On Slide 20, we show the drivers of reported and core operating profit for the quarter. Reported operating profit was JPY 255 billion, a decline of 26.3% versus prior year. Again, the decline is predominantly coming from the gain on the sale of the Japan diabetes portfolio, which contributed JPY 131.4 billion to reported operating profit last year.

在幻燈片 20 中，我們展示了本季度報告的和核心營業利潤的驅動因素。報告的營業利潤為 2,550 億日元，比上年下降 26.3%。同樣，下降主要來自出售日本糖尿病產品組合的收益，該產品去年為報告的營業利潤貢獻了 1314 億日元。

We also had some one-off items impacting the other column here, such as impairment of intangible assets, which includes NATPARA and higher prelaunch inventory in preparation for future launches. As a reminder, the main impact on reported operating profit growth is due to the sale of the diabetes portfolio in Q1 of last year. This will unwind over the coming quarters, and we are forecasting for full year reported operating profit growth of 15%.

我們還有一些影響此處另一列的一次性項目，例如無形資產的減值，其中包括 NATPARA 和為未來發布做準備的更高的發布前庫存。提醒一下，對報告的營業利潤增長的主要影響是由於去年第一季度出售了糖尿病產品組合。這將在未來幾個季度放鬆，我們預計全年報告的營業利潤增長 15%。

Core operating profit was JPY 625.2 billion, with our business momentum driving 14.5% growth at constant exchange rate and FX, an incremental tailwind driving total growth of 28.7%.

核心營業利潤為 6,252 億日元，我們的業務勢頭推動了 14.5% 的固定匯率和外匯增長，增量順風推動了 28.7% 的總增長。

Slide 21 shows our free cash flow of JPY 296.9 billion for the first half, comfortably covering the half year dividend payment and net interest paid as well as the share buyback we completed in April this year. We closed September with ample cash of almost JPY 800 billion and total liquidity of JPY 1.4 trillion or close to USD 10 billion.

幻燈片 21 顯示了我們上半年 2969 億日元的自由現金流，輕鬆涵蓋了半年的股息支付和支付的淨利息以及我們今年 4 月完成的股票回購。我們在 9 月份結束時擁有近 8000 億日元的充足現金和 1.4 萬億日元或接近 100 億美元的總流動性。

Slide 22, the net debt balance is shown here compared to the end of March and demonstrates the continuation of our steady deleveraging progress from 2.8x down to 2.6x. The amount of debt on our balance sheet in Japanese yen terms increased over the period due to the depreciation of the yen versus the dollar and euro.

幻燈片 22，此處顯示的是與 3 月底相比的淨債務餘額，表明我們的去槓桿化進程繼續穩步從 2.8 倍降至 2.6 倍。由於日元兌美元和歐元貶值，我們資產負債表上以日元計算的債務金額在此期間有所增加。

However, as a reminder, the depreciation of yen also benefited EBITDA, which means that the impact of FX on our leverage ratio is small. Also, we have structured the currency denomination of our debt to mirror our cash flow, which ensures that over time, we'll be able to pay down debt without being impacted by FX movements.

然而，提醒一下，日元貶值也有利於 EBITDA，這意味著外匯對我們槓桿率的影響很小。此外，我們已經構建了債務的貨幣計價以反映我們的現金流，從而確保隨著時間的推移，我們將能夠償還債務而不受外匯波動的影響。

On Slide 23, you can see our debt maturity ladder as of September. In addition to the $219 million of fiscal year '22 debt that we paid in April, we also recently called USD 1 billion of debt maturing in fiscal year '23 for prepayment this month. These payments were for USD-denominated bonds with interest rates of 3.6% and 4.4% respectively, allowing us to further optimize our debt profile.

在幻燈片 23 上，您可以看到我們截至 9 月的債務到期階梯。除了我們在 4 月支付的 22 財年 2.19 億美元的債務外，我們最近還要求在 23 財年到期的 10 億美元債務於本月提前償還。這些付款是針對利率分別為 3.6% 和 4.4% 的美元計價債券，使我們能夠進一步優化我們的債務狀況。

We are on track towards our plan of paying off approximately JPY 500 billion of debt this fiscal year, targeting higher than average interest debt. As a reminder, our current weighted average interest rate is approximately 2%. And importantly, 98% of our total debt is at fixed interest rates. And by November 2022, we expect our debt to be at 100% fixed rates. This puts us in a very strong position in the current macro environment of rising interest rates.

我們正在朝著本財年償還約 5000 億日元債務的計劃邁進，目標是高於平均利息債務。提醒一下，我們目前的加權平均利率約為 2%。重要的是，我們 98% 的總債務是固定利率的。到 2022 年 11 月，我們預計我們的債務將達到 100% 的固定利率。這使我們在當前利率上升的宏觀環境中處於非常有利的地位。

Finally, I'd like to point out that we've had some positive changes in our recent credit ratings with both JCR and R&I upgrading our ratings recently.

最後，我想指出，我們最近的信用評級發生了一些積極的變化，JCR 和 R&I 最近都提高了我們的評級。

So next to Slide 24, where we reconfirm our full year management guidance for growth at constant exchange rate, with core revenue growing at low single digit and core operating profit and core EPS growing at high single digit.

因此，在幻燈片 24 旁邊，我們再次確認了以恆定匯率計算的全年管理指導，核心收入以低個位數增長，核心營業利潤和核心每股收益以高個位數增長。

For our reported and core forecast, we are upgrading our numbers primarily to reflect FX tailwinds. On a reported basis, we increased our revenue forecast to JPY 3.93 trillion, operating profit to JPY 530 billion, and EPS to JPY 198 with strong growth rates versus prior year.

對於我們的報告和核心預測，我們正在上調我們的數據，主要是為了反映外匯順風。根據報告，我們將收入預測上調至 3.93 萬億日元，營業利潤上調至 5,300 億日元，EPS 上調至 198 日元，與去年相比增長強勁。

On a core basis, revenue is expected to be JPY 3.93 trillion, with core operating profit now expecting to reach JPY 1.18 trillion and core EPS to reach JPY 525. This represents growth of approximately 15% for core revenue and 23% for core operating profit and core EPS. This upgrade is based on FX rate assumptions using the first half average FX rate specifically, JPY 132 to the U.S. dollar and JPY 138 to the euro.

在核心基礎上，收入預計為 3.93 萬億日元，核心營業利潤目前預計將達到 1.18 萬億日元，核心每股收益將達到 525 日元。這意味著核心收入增長約 15%，核心運營利潤增長 23%和核心EPS。此次升級基於使用上半年平均匯率的匯率假設，即 132 日元兌美元和 138 日元兌歐元。

Finally, we are also increasing our outlook for free cash flow from JPY 600 billion to JPY 700 billion now to JPY 650 billion to JPY 750 billion, primarily reflecting the FX benefit. We also remain fully committed to our full year dividend of JPY 180 per share.

最後，我們還將自由現金流的前景從 6000 億日元提高到 7000 億日元，現在提高到 6500 億日元到 7500 億日元，主要反映了外匯收益。我們還完全致力於實現每股 180 日元的全年股息。

To close out the presentation on Slide 25, I'd like to reemphasize the key elements of our strategy to deliver sustainable growth and value for shareholders. We continue to see strong momentum from our commercial portfolio, which enabled us to deliver 5.5% core revenue growth at constant exchange rate in the first half of this fiscal year. This is driven predominantly by our Growth & Launch Products, growing at 19% on a CER basis, more than offsetting the impact of generic versions of VELCADE in May in 2022.

在結束幻燈片 25 的演示文稿時，我想再次強調我們為股東提供可持續增長和價值的戰略的關鍵要素。我們的商業投資組合繼續保持強勁勢頭，這使我們能夠在本財年上半年按固定匯率實現 5.5% 的核心收入增長。這主要是由我們的增長和推出產品推動的，在 CER 的基礎上增長了 19%，超過了 2022 年 5 月 VELCADE 通用版本的影響。

Our margins are strong with 31.7% core operating profit margin in H1, and we delivered core operating profit growth of 14.5% at constant exchange rate, well on track towards our full year guidance of high single-digit growth.

我們的利潤率強勁，上半年核心營業利潤率為 31.7%，按固定匯率計算，我們實現了 14.5% 的核心營業利潤增長，完全符合我們全年高個位數增長的指引。

And our success is built on a solid financial foundation with robust cash flow that we will continue to allocate towards growth opportunities, continued deleveraging, and competitive shareholder returns. We have abundant liquidity and a well-structured debt profile of 98% fixed rates at an average cost of 2%, which positions us well in the changing macro environment.

我們的成功建立在堅實的財務基礎和強勁的現金流上，我們將繼續將其分配給增長機會、持續去槓桿化和有競爭力的股東回報。我們擁有充裕的流動性和結構良好的債務狀況，固定利率為 98%，平均成本為 2%，這使我們在不斷變化的宏觀環境中處於有利地位。

Finally, before we open it up to Q&A, I'd like to bring to your attention an upcoming investor call we have scheduled for mid-December, focusing on our launch plans and commercial strategy for QDENGA. We look forward to your participation in this event.

最後，在我們開始問答之前，我想提請您注意我們計劃於 12 月中旬舉行的即將舉行的投資者電話會議，重點關注我們對 QDENGA 的發布計劃和商業戰略。我們期待您的參與。

With that, I'd like to open it up for Q&A. Thank you very much.

有了這個，我想打開它進行問答。非常感謝。

[Interpreted] Now I would like to take your questions. In addition to Christophe, Andy and Costa, the management team, which you can see on the slide is also present to take your questions. (Operator Instructions)

[解釋] 現在我想回答你的問題。除了 Christophe、Andy 和 Costa，您可以在幻燈片上看到的管理團隊也在現場回答您的問題。 （操作員說明）

Now I'd like to take the first questions. From Citi, Yamaguchi-san. Please unmute yourself and ask your questions.

現在我想回答第一個問題。花旗，山口先生。請取消靜音並提出您的問題。

Can you hear me, okay? I'm Yamaguchi.

你能聽到我的聲音，好嗎？我是山口。

Yes, we can hear you well.

是的，我們可以很好地聽到您的聲音。

I have two questions. First question is for this quarter, you are doing very well. And next quarter, VYVANSE patent cliff is going to be something you are facing. But new products are doing well. So for the next fiscal year, your revenue is going to be more or less flat, but your profit is going to come down according to your guidance. Is there any updated guidance? That's my first question.

我有兩個問題。第一個問題是本季度的，你做得很好。下個季度，您將面臨 VYVANSE 專利懸崖。但新產品做得很好。因此，在下一個財政年度，您的收入或多或少會持平，但根據您的指導，您的利潤會下降。有更新的指導嗎？這是我的第一個問題。

And the second question is about TAK-861. By the end of this fiscal year, you are going to obtain POC, that's been confirmed. Is there any latest update whether the study is going well? And if you'll be able to obtain POC before the end of this fiscal year, can you comment on that?

第二個問題是關於 TAK-861。到本財年末，您將獲得 POC，這已得到確認。是否有任何最新更新是否研究進展順利？如果您能夠在本財政年度結束前獲得 POC，您能對此發表評論嗎？

Great. Thank you very much, Yamaguchi-san for your question. First, let me just say that I'm very pleased with our first half results for fiscal year 2022. We're showing very strong growth, as you mentioned, on the Growth & Launch Products, growing at 19%. This generated USD 1.4 billion in revenue for the first half of the year. And with this trajection and continuation of growth, as you mentioned, we feel like this could potentially offset the impact next year of VYVANSE loss of exclusivity.

偉大的。非常感謝山口先生的提問。首先，我只想說，我對我們 2022 財年上半年的業績感到非常滿意。正如你所提到的，我們在增長和推出產品方面表現出非常強勁的增長，增長了 19%。這在今年上半年創造了 14 億美元的收入。正如您所提到的，隨著這種軌跡和增長的持續，我們認為這可能會抵消明年 VYVANSE 失去排他性的影響。

Just as a reminder, VYVANSE loss of exclusivity -- loss of exclusivity is more targeted around August. So you don't have the full impact, not full 12 months impact there.

提醒一下，VYVANSE 失去排他性——失去排他性在 8 月左右更有針對性。所以你沒有完全的影響，沒有完整的 12 個月的影響。

Having said that, on the margin side, we are looking at managing our margins accordingly. The Growth & Launch Products is also highly high-margin products. Overall, they have higher margins than the total company. And then, of course, on the OpEx standpoint, we will continue to stay very laser-focused on managing our OpEx to ensure that we have a sustainable core operating profit margin.

話雖如此，在利潤率方面，我們正在考慮相應地管理我們的利潤率。增長和推出產品也是高利潤率的產品。總體而言，他們的利潤率高於整個公司。然後，當然，從運營支出的角度來看，我們將繼續非常專注於管理我們的運營支出，以確保我們擁有可持續的核心運營利潤率。

We'll give you more information in May when we give our guidance. But directionally, we are feeling pretty solid about this year and also with the trajection of that Growth & Launch Products next year and our cost management. I think this is something that we can manage the overall core operating profit margin. But we'll give you more information in May of next year when we give our '23 guidance.

我們將在 5 月份提供指導時為您提供更多信息。但從方向上講，我們對今年以及明年的增長和發布產品的發展軌跡以及我們的成本管理感到非常穩定。我認為這是我們可以管理整體核心營業利潤率的東西。但我們將在明年 5 月提供 '23 指導時為您提供更多信息。

Yamaguchi-san, this is Andy. Thank you for your question for TAK-861. So yes, the study is going very well. This is our Phase I, Phase Ib study. We're currently in the process of enrolling and evaluating patients with type 1 narcolepsy with 4 weeks of treatment with TAK-861. We know TAK-861 is an active molecule. We've looked at sleep deprived healthy volunteers.

山口同學，這是安迪。感謝您對 TAK-861 的提問。所以，是的，這項研究進展順利。這是我們的 I 期 Ib 期研究。我們目前正在招募和評估接受 TAK-861 治療 4 週的 1 型嗜睡症患者。我們知道 TAK-861 是一種活性分子。我們研究了睡眠不足的健康志願者。

The key questions for us are the overall profile, and we're looking at a number of endpoints in the study, the 40-minute mean -- meaningful wakefulness test. We're looking at sleepiness indices, and we're looking at a number of different parameters. And we're also very conscious of dose, since we're trying to understand where that dose -- that optimal dose range is going to be for TAK-861.

對我們來說，關鍵問題是整體概況，我們正在研究研究中的一些終點，即 40 分鐘平均值——有意義的清醒測試。我們正在研究嗜睡指數，我們正在研究許多不同的參數。而且我們也非常注意劑量，因為我們試圖了解該劑量的位置——TAK-861 的最佳劑量範圍。

We're planning at risk to begin a Phase IIb study later this year. So we're waiting now for the totality of data to come in, and we'll have all of those data to support that decision by the end of the fiscal year.

我們計劃在今年晚些時候開始一項 IIb 期研究。所以我們現在正在等待全部數據的到來，我們將在本財政年度結束前擁有所有這些數據來支持該決定。

[Interpreted] Next question is Stacy Ku from Cowen.

[解釋] 下一個問題是來自 Cowen 的 Stacy Ku。

Stacy Ku from Cowen. Congratulations on the progress. So first question is, as you continue to nicely deleverage, can you expand some more on the potential strategy for business development, which core therapeutic areas are you identifying opportunities and maybe clarify the potential phase and development and potential size of the opportunity? So that's the first question.

來自 Cowen 的 Stacy Ku。祝賀取得進展。所以第一個問題是，隨著您繼續很好地去槓桿化，您能否進一步擴展業務發展的潛在戰略，您正在識別哪些核心治療領域的機會，並可能澄清潛在的階段和發展以及機會的潛在規模？所以這是第一個問題。

And then for ENTYVIO, as we approach 2023, I wanted to confirm if the subcutaneous offering is still on track. So do you expect filing for both UC and CD? And does the updated guidance include subcutaneous contribution in 2024?

然後對於 ENTYVIO，隨著我們接近 2023 年，我想確認皮下產品是否仍在進行中。那麼您希望同時申請 UC 和 CD 嗎？更新後的指南是否包括 2024 年的皮下貢獻？

And then last, kind of another follow-up on ENTYVIO. Just can you provide some additional details between the potential drivers between the high and the low end of the peak sales? There are a few moving pieces. So is it the competition that we should be considering when you look at this wide range? Or is it more the potential impact from biosimilar entry? So any additional details would be appreciated.

最後，關於 ENTYVIO 的另一種後續行動。您能否在銷售高峰的高端和低端之間的潛在驅動因素之間提供一些額外的細節？有一些動人的部分。那麼當你看到這個廣泛的範圍時，我們應該考慮競爭嗎？還是生物仿製藥進入的潛在影響更大？因此，任何額外的細節將不勝感激。

Yes. Thank you, Stacy. It's Christophe. So on the BD front, we want to enrich our pipeline. So the first thing is that we are not looking for large M&A. We have the scale we need -- we have the -- we are global, we can compete in every key market.

是的。謝謝你，斯泰西。是克里斯托夫。因此，在 BD 方面，我們希望豐富我們的管道。所以第一件事是我們不是在尋找大型併購。我們有我們需要的規模——我們有——我們是全球性的，我們可以在每個關鍵市場上競爭。

By the way, QDENGA is a vaccine that we can loan by ourselves because we have such a strong presence in countries which are endemic. It's a good example of how you combine innovation and globalization and how can you can launch your global product. But we do seek to enrich our pipeline. We have 40 product in development in the pipeline, but we know that not all of them will make it. So we are looking at enriching our pipeline. So we are looking at assets which are in mid, late stage. I'd say that, that could be launched before end of the decade. And we are focusing on our core therapy area.

順便說一句，QDENGA 是一種我們可以自己借用的疫苗，因為我們在流行的國家擁有如此強大的存在。這是一個很好的例子，說明您如何將創新和全球化結合起來，以及如何推出您的全球產品。但我們確實尋求豐富我們的管道。我們有 40 種產品正在開發中，但我們知道並非所有產品都能成功。因此，我們正在考慮豐富我們的管道。因此，我們正在研究處於中後期的資產。我想說的是，這可能會在本世紀末之前推出。我們專注於我們的核心治療領域。

Sometimes, if there is adjacency, we could look at it as well, but that's mainly where we are looking at. And you have seen our cash flow. Very soon, we'll be in the low 2s. So we have some firepower, if you like, to do this type of very targeted business development. But it's really asset by asset. We're not, again, we are not looking at scale. We are looking at quality assets.

有時，如果存在鄰接，我們也可以查看它，但這主要是我們要查看的地方。你已經看到了我們的現金流。很快，我們將進入低 2 秒。因此，如果您願意，我們有一些火力來進行這種非常有針對性的業務發展。但它確實是逐項資產。我們不是，再一次，我們不是在看規模。我們正在尋找優質資產。

Thank you, Stacy, for your questions. So it's Ramona here. So let me answer your questions about ENTYVIO. So first of all, absolutely the subcutaneous form is still very much on track to be filed in FY '23 as we've previously disclosed. We're confident that we have the package to be able to file that. And we're excited actually looking forward to bringing the subcu to the U.S. market.

謝謝你，斯泰西，你的問題。所以這裡是雷蒙娜。因此，讓我回答您有關 ENTYVIO 的問題。因此，首先，正如我們之前披露的那樣，皮下表格絕對仍有望在 23 財年提交。我們相信我們有能夠提交該文件的包。我們很興奮實際上期待將 subcu 帶入美國市場。

On the range that we provided for ENTYVIO, in the situation where we were not to get a subcu in the U.S., certainly that would put us towards the lower end of the range. But as all of our projections are on track, you would expect us to be more in the mid- to higher level of the range. And the reason for the range is, as you said, the competition.

在我們為 ENTYVIO 提供的範圍內，在我們無法在美國獲得 subcu 的情況下，這肯定會使我們處於範圍的低端。但由於我們所有的預測都在正軌上，你會期望我們更多地處於該範圍的中高水平。正如您所說，範圍的原因是競爭。

So depending on how standard of practice changes with a number of new molecules coming into the market, it's very difficult to project now 5, 6, 7 years out. And so we're giving ourselves a range to be able to do that. But we're -- everything we're seeing right now in the market, even with new products coming on board is that ENTYVIO is just more and more being solidified as a safe, effective first-line foundation therapy for IBD. So we feel very positive about all of the underlying trends we're seeing even with new products entering the market.

因此，取決於實踐標準如何隨著大量新分子進入市場而發生變化，現在很難在 5、6、7 年後進行預測。所以我們給自己一個範圍來做到這一點。但我們現在在市場上看到的一切，即使有新產品上市，ENTYVIO 也越來越被鞏固為 IBD 的安全、有效的一線基礎療法。因此，即使有新產品進入市場，我們也對我們看到的所有潛在趨勢感到非常樂觀。

[Interpreted] Moving on to the next question, Nomura Securities, Kohtani-san. Please unmute yourself and ask your question.

[解釋] 繼續下一個問題，野村證券，Kohtani-san。請取消靜音並提出您的問題。

(inaudible)

（聽不清）

This is Teresa Bitetti responding here. So you are right about the ALTA 3 trial. But what we have found is that ALUNBRIG continues to deliver strong year-over-year results driven by what we've seen is growth in EU-CAN and Japan as well as in our growth in our emerging markets.

這是 Teresa Bitetti 在這裡回應。所以你對 ALTA 3 試驗是正確的。但我們發現，ALUNBRIG 在歐盟-加拿大和日本的增長以及我們在新興市場的增長的推動下，繼續取得強勁的同比業績。

We're continuing to focus our efforts. So even without the head-to-head trial, we're focusing our efforts in the first-line setting, where it's clear that there's strong benefit for ALUNBRIG, which includes the overall improved intracranial efficacy, long-term tolerability, dosing impact and quality of life, that are really meeting the needs of patients. So there's still a lot of growth in this product, and we're going to continue to focus our efforts there.

我們將繼續集中精力。因此，即使沒有頭對頭試驗，我們也將努力集中在一線環境中，很明顯 ALUNBRIG 有很大的好處，包括整體改善顱內療效、長期耐受性、劑量影響和生活質量，真正滿足患者的需求。所以這個產品還有很大的增長空間，我們將繼續把精力集中在那裡。

Kohtani-san, it's Julie Kim. I'm going to take your TAKHZYRO question because I believe you're asking more about the dynamics in the U.S. market. So for TAKHZYRO, we are seeing good growth, good market demand for TAKHZYRO. We continue to believe in the strong efficacy profile that TAKHZYRO provides for patients, and we're seeing that in terms of the resurgence in demand.

Kohtani-san，是朱莉·金。我將回答您的 TAKHZYRO 問題，因為我相信您正在詢問更多有關美國市場動態的信息。因此，對於 TAKHZYRO，我們看到 TAKHZYRO 的良好增長和良好的市場需求。我們繼續相信 TAKHZYRO 為患者提供的強大療效，而且我們看到了需求的複蘇。

From a market dynamic standpoint, while anecdotally, we are seeing some patients who have started on oral come back to TAKHZYRO because of the efficacy profile that we have. There isn't anything specific that we would comment on that beyond the anecdotal evidence that we have seen.

從市場動態的角度來看，雖然有趣的是，我們看到一些開始口服的患者因為我們擁有的療效特徵而回到 TAKHZYRO。除了我們所看到的軼事證據之外，我們沒有任何具體的評論。

From an execution standpoint, what I would comment on is that we've been working very hard on, let's say, eliminating friction in the system. There are quite a lot of hurdles that patients still need to go through to get on therapy once they are diagnosed. And so some of that resurgence in demand we believe, is because of our efforts in terms of, as I said, eliminating friction in the system to allow patients to have access to therapy much faster. Thank you.

從執行的角度來看，我要評論的是，我們一直在非常努力地工作，比如說，消除系統中的摩擦。一旦被診斷出來，患者仍然需要經歷很多障礙才能接受治療。因此，我們認為，需求的複蘇是因為我們努力，正如我所說，消除系統中的摩擦，讓患者能夠更快地獲得治療。謝謝你。

Thank you, Kohtani-san question. Let me just without giving guidance for fiscal year '24, give you some key pushes and pulls here. Firstly, the VYVANSE impact will be more heavily weighted in 2023, for sure. There will be some carryover in 2024, but the majority as a proportion will be impacting us in 2023. For 2024, the impact overall for loss of exclusivity will be much less than what we've experienced in fiscal year 2023 and also in 2022. So overall, the LOE in '24 will be much lower.

謝謝小谷桑的問題。讓我在不為 24 財年提供指導的情況下，在這裡給你一些關鍵的推動和拉動。首先，VYVANSE 的影響肯定會在 2023 年得到更大的重視。 2024 年會有一些結轉，但大部分將在 2023 年影響我們。對於 2024 年，失去排他性的總體影響將遠小於我們在 2023 財年和 2022 財年所經歷的影響。所以總的來說，24 年的 LOE 會低得多。

Then on the flip side, on the top line revenue, we continue to see growth of our Growth & Launch Products accelerating. We have QDENGA launching as well, and that will still also continue to drive some top line revenue growth.

然後在另一方面，在收入方面，我們繼續看到我們的增長和發布產品的增長加速。我們也推出了 QDENGA，這也將繼續推動一些收入增長。

And then finally, on the OpEx, we'll continue to manage G&A, SG&A, OpEx, we will continue to improve our PDT profitability. You saw that this year and last year, we've had some dynamics, market dynamics, which has increased overall donor fees, but that's starting to, as you saw in Q2 year-to-date, our donor fees have started to come down by more than 15% versus prior year. So we expect improvements in PDT profitability as well.

最後，在運營支出方面，我們將繼續管理 G&A、SG&A、運營支出，我們將繼續提高 PDT 的盈利能力。你看到今年和去年，我們有一些動態，市場動態，這增加了整體捐助者費用，但正如你在今年第二季度看到的那樣，我們的捐助者費用開始下降比上年增長 15% 以上。因此，我們預計 PDT 的盈利能力也會有所改善。

Now there was a question on the ALUNBRIG impairment. We do regular tests as well. Every year and every planning cycle, we still have a buffer here on ALUNBRIG. It's not just on revenue, but it's the overall cash flow NPV versus the purchase price. So we get this assessed on a regular basis by our external auditors. And thus far, we have not triggered any impairments. Thank you very much, Kohtani-san for your questions.

現在有一個關於 ALUNBRIG 損傷的問題。我們也定期進行測試。每年和每個計劃週期，我們在 ALUNBRIG 上仍然有緩衝。這不僅僅是收入，而是整體現金流 NPV 與購買價格的關係。因此，我們的外部審計師會定期對此進行評估。到目前為止，我們還沒有引發任何損害。非常感謝 Kohtani 先生的提問。

[Interpreted] Next question is from Morgan Stanley Securities, Muraoka-san.

[解釋] 下一個問題來自摩根士丹利證券村岡先生。

I'm Muraoka from Morgan Stanley. Do you hear me okay?

我是摩根士丹利的村岡。你聽我說好嗎？

Yes.

是的。

My first question is about shareholders' returns. Leverage has come down and your performance is quite good. So probably you can start thinking about increasing your dividend. It's actually high time for you to think about it. Any comments, including the timing of doing that? What's your thought on that? That's my first question.

我的第一個問題是關於股東回報的。槓桿下降了，你的表現還不錯。因此，您可能可以開始考慮增加股息。現在是你考慮的時候了。任何意見，包括這樣做的時間？你對此有何看法？這是我的第一個問題。

The second question. Two new products, LIVTENCITY and EXKIVITY. During the first quarter, their growth looked very well. But during the second quarter, if I look at the numbers, quarter-on-quarter, it looks like the growth rates are flat. What's the background? Is this slowing down? Or is this just a transient situation? Can you give me some background of that? That's all from me.

第二個問題。兩款新產品，LIVTENCITY 和 EXKIVITY。在第一季度，他們的增長看起來非常好。但是在第二季度，如果我看一下季度環比的數字，看起來增長率是持平的。背景是什麼？這是在減速嗎？或者這只是暫時的情況？你能給我一些背景嗎？這都是我的。

Yes. Thank you, Muraoka-san, for your questions. It's a great question and it's definitely something we're looking at, in particular, as we continue to deleverage. We've promised as part of the capital allocation policy to deleverage rapidly and to get down to the low 2x. We're on track to delivering that target. You saw already in Q2 year-to-date, we've gone -- we're down to 2.6x. But we're still not there. We're still not at low 2x.

是的。謝謝村岡先生的提問。這是一個很好的問題，而且絕對是我們正在關注的問題，尤其是在我們繼續去槓桿化的過程中。作為資本配置政策的一部分，我們已承諾迅速去槓桿並降至低點 2 倍。我們正在實現這一目標。你已經在今年第二季度看到了，我們已經走了——我們已經下降到 2.6 倍。但我們還沒有。我們仍然沒有低於 2 倍。

But I'm confident that we're going to get there and potentially even get there faster than our original committed timeline of fiscal year '23. So once we close this, we'll get -- we have a lot more firepower, a lot more cash flow. Our free cash flow continues to grow. And then, of course, we will look at reducing the number of capital allocation drivers.

但我相信我們會達到目標，甚至可能比我們最初承諾的 23 財年時間表更快。因此，一旦我們關閉它，我們將獲得 - 我們擁有更多的火力，更多的現金流。我們的自由現金流繼續增長。然後，當然，我們將考慮減少資本配置驅動因素的數量。

Today, we have 3. It's investing in our growth drivers, deleveraging rapidly and shareholder returns. Once we deleverage down to the low 2s, we'll have two areas of focus. One, the continuation of investing for growth, which could be also, as Christophe alluded to, acceleration of acquisitions, later-stage acquisitions for growth, continue to invest in R&D, both in-house and partnerships, continuing to invest in new product launches.

今天，我們有 3 個。它投資於我們的增長動力、快速去槓桿和股東回報。一旦我們將槓桿率降至低 2，我們將有兩個重點領域。一，繼續投資增長，也可能，正如克里斯托夫所暗示的，加速收購，後期收購增長，繼續投資於內部和合作夥伴的研發，繼續投資於新產品的發布.

And then the second one is, obviously, the shareholder returns and look and perhaps dividend increases could be definitely on the cards there. So thank you very much, Muraoka-san, for your question, and we are looking into it. Thank you.

然後第二個顯然是股東回報和外觀，也許股息增加肯定會在那裡。非常感謝村岡先生的提問，我們正在調查中。謝謝你。

So Muraoka-san, this is Julie Kim. I can take your question on LIVTENCITY and then I'll pass to Teresa for EXKIVITY. So in terms of LIVTENCITY, we're very, very excited about the treatment option that this provides for individuals with CMV refractory, CMV, as there really wasn't a treatment available to them.

村岡先生，我是朱莉·金。我可以回答你關於 LIVTENCITY 的問題，然後我會轉給 Teresa 討論 EXKIVITY。因此，就 LIVTENCITY 而言，我們對它為 CMV 難治性 CMV 患者提供的治療選擇感到非常非常興奮，因為他們確實沒有可用的治療方法。

What we are seeing in terms of the growth that you've pointed out is not a new trend per se. Transplant is an acute situation, it is an event that happened. So it's very hard to predict when patients will need LIVTENCITY as a treatment. What we are very encouraged by is the fact that we have over 90% of our patients receiving full course of therapy.

我們所看到的您所指出的增長本身並不是一個新趨勢。移植是一種緊急情況，它是一個發生的事件。因此，很難預測患者何時需要 LIVTENCITY 作為治療。令我們感到非常鼓舞的是，我們有超過 90% 的患者接受了全程治療。

We have very high coverage, over 90% coverage from a reimbursement standpoint. And we have over 80% of the centers now treating patients with LIVTENCITY. And so there's still opportunity for growth, and we expect LIVTENCITY to continue to do well. Teresa?

我們的覆蓋率非常高，從報銷的角度來看，覆蓋率超過 90%。我們現在有超過 80% 的中心治療 LIVTENCITY 患者。因此仍有增長的機會，我們預計 LIVTENCITY 將繼續表現良好。特蕾莎？

This is Teresa. Thanks for the question on EXKIVITY. We continue to be pleased with the results of EXKIVITY's launch in the U.S. market. And the data shows that EXKIVITY continues to capture half of all new patient starts among the two branded EGFR exon 20 treatment options that are there. So we continue to see the increased potential for more growth. We do see an opportunity to increase duration of therapy. So we are working with physicians to make sure that we educate very clearly on side effect management dosing and the importance of the duration of that therapy. So there is no change to our growth forecast at the moment. I mean we'll continue to keep an eye on that and keep you updated as we gain more and more insights as we continue to launch EXKIVITY.

這是特蕾莎。感謝您提出關於 EXKIVITY 的問題。我們繼續對 EXKIVITY 在美國市場推出的結果感到滿意。數據顯示，在現有的兩個品牌 EGFR 外顯子 20 治療方案中， EXKIVITY 繼續佔據所有新患者的一半。因此，我們繼續看到更大的增長潛力。我們確實看到了增加治療時間的機會。因此，我們正在與醫生合作，以確保我們非常清楚地了解副作用管理劑量和治療持續時間的重要性。因此，目前我們的增長預測沒有變化。我的意思是，隨著我們繼續推出 EXKIVITY，隨著我們獲得越來越多的見解，我們將繼續關注這一點並為您提供最新信息。

[Interpreted] Thank you, Muraoka-san. Next question is JPMorgan, Wakao-san.

[解釋] 謝謝你，村岡先生。下一個問題是摩根大通，Wakao-san。

This is Wakao, JPMorgan. I have two questions. As this ENTYVIO peak sales increase, in Page 12, you listed up several factors for this upgrade. But which one is the biggest factor?

這是摩根大通的Wakao。我有兩個問題。隨著 ENTYVIO 銷售高峰的增加，您在第 12 頁列出了此次升級的幾個因素。但哪一個是最大的因素？

The top is, the ones most important, meaning biosimilar entry is not now expected in to 2032. Is that the biggest reason? Looking at the current situation, ENTYVIO share seems to be very close to the peak. But do you think that as market grows, then ENTYVIO sales will also grow?

最重要的是，這意味著生物仿製藥現在預計不會在 2032 年進入。這是最大的原因嗎？從目前的情況來看，ENTYVIO 的份額似乎已經非常接近峰值。但是你認為隨著市場的增長，ENTYVIO 的銷量也會增長嗎？

Next is about TAK-861. Regarding the TAK-861 whether to continue the study or not, I think you will make a decision within this year. That's what I heard. But now I think it's shifted to by the end of March. Does that mean that you need to take longer time to make a decision? And also, what about the safety profile of TAK-861?

接下來是關於 TAK-861。關於TAK-861是否繼續研究，我想你會在今年內做出決定。這就是我聽到的。但現在我認為它已經轉移到了三月底。這是否意味著您需要花費更長的時間來做出決定？另外，TAK-861 的安全性如何？

I think that you seems to be more careful than myself. So the required criteria of safety for TAK-861 is as now higher or severe? So the other compounds moving on to Phase II compared to those cases, do you think that TAK-861 had to move on to the next phase is the higher?

我認為你似乎比我更小心。那麼，TAK-861 所需的安全標準現在更高還是更嚴格？那麼其他進入第二階段的化合物與那些情況相比，你認為 TAK-861 必須進入下一個階段是更高的嗎？

Yes. Thank you, Wakao-san. Let me answer your question on ENTYVIO peak sales. So you're correct. The major driver of the increased peak sales is the -- basically the increased time on market that allows us to continue to take advantage of the positive trends and grow, and that's what's driving the increased sales.

是的。謝謝你，和高先生。讓我回答您關於 ENTYVIO 高峰銷售的問題。所以你是對的。銷售高峰增加的主要驅動因素是——基本上是上市時間的增加，這使我們能夠繼續利用積極的趨勢並實現增長，這就是推動銷售增長的原因。

We have a number of positive trends, which include, as I mentioned, continued growth in share and continued growth in first-line therapy. We're seeing continued growth of the IBD market, and we expect the subcu to be coming in the U.S. as well. And certainly, we do see more competitors entering the marketplace. So that would be a bit of the headwind but we feel confident in our new peak sales estimate given the positive trends in our favor and the extended time we have with ENTYVIO.

正如我所提到的，我們有許多積極的趨勢，其中包括份額的持續增長和一線治療的持續增長。我們看到 IBD 市場持續增長，我們預計 subcu 也將進入美國。當然，我們確實看到更多的競爭對手進入市場。因此，這將是一個不利因素，但鑑於對我們有利的積極趨勢以及我們與 ENTYVIO 的延長時間，我們對新的銷售峰值估計充滿信心。

On TAK-861, this is Andy. On TAK-861, Wakao-san, we're moving forward the program in an accelerated fashion, and it is entirely on track. So the intent to start a Phase IIb study at the end of this fiscal year is very much in line with what we communicated and signaled at the beginning of the year.

在 TAK-861 上，這是安迪。在 TAK-861 上，Wakao-san，我們正在加速推進該計劃，它完全走上了正軌。因此，在本財年末開始 IIb 期研究的意圖與我們在年初傳達和發出的信號非常一致。

With respect to safety, we're -- as I said, this is a very accelerated program, and we're balancing the potential to bring forward a transformative therapy for patients with narcolepsy, while ensuring that we're doing everything we can to guarantee patient safety. So we're being very thoughtful in how we make and drive decisions given the experience with TAK-994. But we remain extremely excited about the mechanism. And over the next couple of months, we'll have a full data set on TAK-861 that will allow us to make a decision as to whether we move forward or not.

在安全方面，我們 - 正如我所說，這是一個非常加速的計劃，我們正在平衡為嗜睡症患者帶來變革性療法的潛力，同時確保我們正在盡我們所能保證患者安全。因此，鑑於 TAK-994 的經驗，我們在如何制定和推動決策方面非常周到。但我們仍然對該機制感到非常興奮。在接下來的幾個月裡，我們將擁有關於 TAK-861 的完整數據集，這將使我們能夠決定是否繼續前進。

[Interpreted] Thank you very much, Wakao-san. Next question Credit Suisse Securities, Sakai-san. Please unmute the microphone and ask your question.

[解釋] 非常感謝你，Wakao 先生。下一個問題瑞士信貸證券，Sakai-san。請取消麥克風靜音並提出您的問題。

This is Sakai with Credit Suisse. First question to Costa. So you made an upward revision. And on Page 20, core profit margin for the first half. There was a JPY 69.1 billion factor from FX. And for full year, it's JPY 800 billion. So I understand that ForEx was taken into account. And Supplement A 16 shows the sensitivity for exchange rate. You have some assumptions there.

這是瑞士信貸的Sakai。對科斯塔的第一個問題。所以你做了一個向上的修正。在第 20 頁，上半年的核心利潤率。來自外彙的因素為 691 億日元。全年為8000億日元。所以我知道外匯交易被考慮在內。附錄 A 16 顯示了對匯率的敏感性。你有一些假設。

And for the full year, JPY 132. So this is not much different from the first half JPY 131. And based on that, you came up with this JPY 80 billion. In terms of core margin, maybe the margin would go down? That's my question. So how did you calculate that? What is the formula? Can you please explain how you calculated these numbers? That's my first question.

全年為 132 日元。所以這與上半年的 131 日元沒有太大區別。基於此，您得出了 800 億日元。就核心利潤率而言，利潤率可能會下降？那是我的問題。那你是怎麼計算的？公式是什麼？你能解釋一下你是如何計算這些數字的嗎？這是我的第一個問題。

And another question is for Andy. So Orexin Phase Ib study that's been mentioned before. This is Phase Ib. So there is no blinding. And healthy volunteers, the subject. I'm sure that you have seen the raw data to a great extent. And based on all the data you have seen already, you don't see any safety signals. Is that a correct understanding? So those are the two questions.

另一個問題是給安迪的。所以之前提到過的 Orexin Ib 期研究。這是階段 Ib。所以沒有盲點。和健康的志願者，主題。我相信你已經在很大程度上看到了原始數據。根據您已經看到的所有數據，您看不到任何安全信號。這是正確的理解嗎？所以這是兩個問題。

Yes. Thank you, Sakai-san, for your question. So if you look at that Slide A-16 in the appendix, you're right, we have the new U.S. dollar, JPY 132 in the -- for the full year assumption now. And year-to-date, it's -- what we saw actual was JPY 131. So the way we calculated the overall future exchange for the U.S. and euro was we use the year-to-date average, okay? So JPY 132 for the USD and JPY 138 for euro.

是的。謝謝酒井同學的提問。因此，如果您查看附錄中的幻燈片 A-16，您是對的，我們現在有全年假設的新美元，即 132 日元。年初至今，我們實際看到的是 131 日元。所以我們計算美元和歐元未來整體匯率的方式是使用年初至今的平均值，好嗎？因此，美元為 132 日元，歐元為 138 日元。

Now we don't see any major impact on the core operating profit because of this. So overall, the COP margin is quite neutral overall to the company because of the product mix and also the cost base that we have.

現在我們認為這對核心營業利潤沒有任何重大影響。因此，總體而言，由於產品組合以及我們擁有的成本基礎，COP 利潤率對公司整體而言是相當中性的。

Now we saw that September, the U.S. dollar was JPY 144 -- the yen to the U.S. dollar was JPY 144. Now if that continues for the rest of the year, we do have further upside. At this stage, it's very hard to predict what the full year impact will be on FX. But if it is around JPY 144, we have further upside to our core revenue, core operating profit and our core EPS. And the upside, if it was similar to what we saw in September of JPY 144 to the U.S. dollar, it would be an upside -- incremental upside of about 3% on the core revenue, around 4% on the core operating profit and approximately 5% on the core EPS. So that gives you a sort of a broad understanding, but no impact to the margin.

現在我們看到 9 月份的時候，美元兌日元是 144 日元——日元兌美元匯率是 144 日元。現在，如果這種情況持續到今年剩下的時間，我們確實還有進一步的上漲空間。在這個階段，很難預測全年對外彙的影響。但如果它在 144 日元左右，我們的核心收入、核心運營利潤和核心每股收益將進一步上漲。上行方面，如果類似於我們在 9 月看到的 144 日元兌美元，那將是一個上行空間——核心收入增加約 3%，核心營業利潤增加約 4%，大約核心每股收益的 5%。所以這給了你一種廣泛的理解，但對利潤沒有影響。

Sakai-san, you're correct. 1b portion of the study is, that doesn't have a comparator arm. It's just an active arm. And in the blinded data to date, it's -- remember, it's 4 weeks of dosing. But in the blinded data today, we don't see any signal to suggest any liver safety issues so far.

堺桑，你說得對。研究的 1b 部分是，它沒有比較器臂。它只是一個活躍的手臂。在迄今為止的盲目數據中，它是 - 請記住，這是 4 週的給藥。但在今天的盲態數據中，到目前為止，我們沒有看到任何表明存在任何肝臟安全問題的信號。

[Interpreted] Next question is from Goldman Sachs Securities, Ueda-san.

[解釋] 下一個問題來自高盛證券，上田先生。

Hi, I'm Ueda from Goldman Sachs. I have two questions. First, going forward, R&D strategy update, when are you going to disclose your updated R&D strategy?

大家好，我是高盛的 Ueda。我有兩個問題。首先，接下來，研發戰略更新，你們什麼時候公佈你們更新的研發戰略？

Last year, you had explanation meeting for Wave 1, giving us outlook for each one of the products in Wave 1. But since then, I'm sure that there have been a lot of updates. Therefore, as of right now, what is the renewed outlook of R&D strategy? And what is the potential you are looking at for each product? And when are you going to update us on that? What is the timing for that? TAK-861, before the end of this fiscal year, you'll be able to have the data. And after that, probably, you can give us an update. So it's going to be early next year that you can update us on that?

去年，你們召開了 Wave 1 的說明會，向我們介紹了 Wave 1 中的每一個產品。但從那以後，我確信有很多更新。那麼，截至目前，研發戰略的新前景如何？您正在尋找每種產品的潛力是什麼？你打算什麼時候更新我們？什麼是時機？ TAK-861，在本財政年度結束之前，您將能夠擁有數據。在那之後，你可能可以給我們一個更新。所以明年年初你可以更新我們嗎？

And the second question is about PDT, about the donor fee development, Page 34. Right now, the donor fee is coming down. You are showing that on that page. But as of now, the current level compared to the pre-COVID time before the donor fee went up, how do you compare the current level compared to the pre-pandemic level? And this declining trend, is it going to continue?

第二個問題是關於 PDT，關於捐助者費用的發展，第 34 頁。現在，捐助者費用正在下降。您正在該頁面上顯示該內容。但截至目前，目前的水平與捐贈費上漲前的疫情前水平相比，您如何將當前水平與大流行前的水平進行比較？而這種下降趨勢，會不會持續下去？

Yes. First, we update about our pipeline at every quarter, so we keep you updated. We will organize an R&D Day as soon as we will have enough new events, new readout. So either it will be in fiscal year 2022 or at the beginning of '23. We have not decided the date yet.

是的。首先，我們每個季度都會更新我們的管道，因此我們會隨時為您提供最新信息。一旦我們有足夠的新活動，新的讀數，我們將組織一個研發日。因此，要么是在 2022 財年，要么是在 23 年初。我們還沒有決定日期。

Yes. This is Giles speaking. So as Costa mentioned, we have been able to reduce year-on-year donor compensation by upwards of 15% for the first half of fiscal '22. We continue to monitor market dynamics closely as we need to strike the right balance between collecting enough plasma to meet our commitments to patients and of course, improving margins. Our ability to continue on this trajectory will be contingent on market dynamics. Thank you for the question.

是的。這是賈爾斯說話。因此，正如科斯塔所提到的，我們已經能夠在 22 財年上半年將捐助者薪酬同比減少 15% 以上。我們將繼續密切關注市場動態，因為我們需要在收集足夠的血漿以履行我們對患者的承諾以及提高利潤率之間取得適當的平衡。我們能否繼續沿著這條軌跡前進將取決於市場動態。感謝你的提問。

[Interpreted] We'd like to move onto the next question. Next is Mitsubishi UFJ Morgan Stanley, Kumagai-san, please.

[解釋] 我們想進入下一個問題。接下來是三菱 UFJ 摩根士丹利，熊谷先生。

This is Kumagai, Mitsubishi UFJ Morgan Stanley. Can you hear me?

這是熊谷，三菱日聯摩根士丹利。你能聽到我嗎？

Yes.

是的。

I have two questions. One is about QDENGA. About your pricing strategy, I'd like to hear more. I think it depends probably on country. So what is your view about the pricing? And second is the TAK-227, it is a very interesting molecule, I think. And what's your future development program over TAK-227 as much as you can disclose?

我有兩個問題。一是關於QDENGA。關於您的定價策略，我想了解更多。我認為這可能取決於國家。那麼您對定價有何看法？第二個是 TAK-227，我認為它是一個非常有趣的分子。您可以透露的關於 TAK-227 的未來發展計劃是什麼？

Yes. Thank you very much, Kumagai-san, I would like to take the question on QDENGA pricing. So first of all, let me remind you that dengue is endemic in over 100 countries. Many of these are some of the most populous countries in the world.

是的。非常感謝熊谷先生，我想回答關於 QDENGA 定價的問題。所以首先，讓我提醒你，登革熱在 100 多個國家流行。其中許多是世界上人口最多的國家。

And as we bring this vaccine out globally, we want to make sure that it's accessible to all of the patients who need it, both in private and in public markets, in travel markets and in endemic markets. So what we're doing with dengue (sic) [QDENGA] is we're going to be coming out with a tiered pricing strategy so that we can segment markets based on health care sophistication and make sure that it becomes available to the patients who need it.

當我們在全球推出這種疫苗時，我們希望確保所有需要它的患者都能獲得它，無論是在私人市場還是公共市場、旅遊市場和流行市場。因此，我們對登革熱 (原文如此) [QDENGA] 所做的是，我們將推出分層定價策略，以便我們可以根據醫療保健的複雜程度細分市場，並確保它可供患有以下疾病的患者使用需要它。

We are having a dengue (sic) QDENGA in Investor Relations Day on December 15. And at that time, we will be sharing more about our launch plans and would enjoy you attending that please.

我們將在 12 月 15 日的投資者關係日舉辦登革熱（原文如此）QDENGA。屆時，我們將分享更多關於我們的發布計劃的信息，希望您能參加。

So thank you very much for the question on TAK-227. We're extremely excited about this mechanism. It's easily the most compelling program to emerge in the celiac space now and really ever. And it's working through a very unique mechanism in the intestine where it prevents the ability of the immune system to recognize gluten. It prevents -- it's an enzyme that modifies the gluten fragments that they can't be presented to our immune system. And that mechanistic hypothesis has played out in a Phase II study that was published in the New England Journal of Medicine last year. I encourage you to seek out that article because it's incredibly compelling benefits on multiple pathological endpoints and the suggestion of significant benefits to patient symptoms. It's a really exciting molecule.

非常感謝您提出關於 TAK-227 的問題。我們對這種機制感到非常興奮。它很容易成為現在和真正出現在腹腔領域的最引人注目的程序。它通過腸道中一種非常獨特的機制發揮作用，阻止免疫系統識別麩質的能力。它可以防止 - 它是一種酶，可以修飾無法呈現給我們免疫系統的麵筋片段。這一機制假設已在去年發表在《新英格蘭醫學雜誌》上的一項 II 期研究中得到證實。我鼓勵您尋找那篇文章，因為它在多個病理終點上具有令人難以置信的令人信服的益處，並且對患者症狀的顯著益處的建議。這是一個非常令人興奮的分子。

Right now, our partners at Dr. Falk and Zedira are running a Phase IIb study. It's a 12-week study in patients on a gluten-free to Hyatt. It's actually a different design than the IIa study, which was a gluten challenge study. So we looked at intestinal pathology and symptoms in response to gluten that was given to patients during the study. The Phase IIb study will just look at patients living their normal lives, avoiding gluten. So it's more of a real-life scenario.

目前，我們在 Dr. Falk 和 Zedira 的合作夥伴正在進行一項 IIb 期研究。這是對凱悅無麩質患者進行的為期 12 週的研究。它實際上是與 IIa 研究不同的設計，後者是一項麵筋挑戰研究。因此，我們研究了研究期間給予患者的麩質的腸道病理學和症狀。 IIb 期研究將只關注過正常生活的患者，避免使用麩質。所以這更像是一個真實的場景。

At the completion of the Phase IIb study, Takeda will take control of the global Phase III study. And the FDA has just released a guidance that provides great clarity on what's necessary for an approval in celiac disease. So we'll need both histological and patient-reported outcomes, both of which we've seen benefits on in our Phase IIa study and it will be a 1-year study in duration. So we have a tremendous clarity in terms of that plan. And even before we finalized the deal, we started to work together closely with our partners to build that strategy so we could accelerate it.

在 IIb 期研究完成後，武田將控制全球 III 期研究。 FDA 剛剛發布了一份指南，該指南非常明確地說明了批准乳糜瀉的必要條件。因此，我們需要組織學和患者報告的結果，我們已經在 IIa 期研究中看到了這兩者的好處，這將是一項為期 1 年的研究。因此，就該計劃而言，我們非常清楚。甚至在我們完成交易之前，我們就開始與我們的合作夥伴密切合作，以製定該戰略，以便我們能夠加速它。

[Interpreted] Next question from Suki-san from Bernstein.

[解釋] Bernstein 的 Suki-san 的下一個問題。

(inaudible)

（聽不清）

I'm sorry, but we do not really hear you very well. Could you please ask the second question once again?

很抱歉，我們並沒有真正聽到你的聲音。你能再問第二個問題嗎？

(inaudible)

（聽不清）

Yes, thank you for the question. This is Giles again. Absolutely right. We have been successfully bringing down donor compensation levels, albeit still above pre-pandemic level, but upwards of 15% reduction in the first half of fiscal '22 and all the while maintaining our collection volumes above pre-pandemic levels for the past 18 months, and we're the only 1 of the top 3 companies to be able to achieve that. We do expect that trajectory to continue. Of course, that will depend on market dynamics.

是的，謝謝你的提問。這又是賈爾斯。絕對正確。我們已經成功地降低了捐助者的補償水平，儘管仍高於大流行前的水平，但在 22 財年上半年減少了 15% 以上，同時在過去 18 個月中將我們的收集量保持在大流行前的水平之上，我們是前 3 名公司中唯一能夠實現這一目標的公司之一。我們確實預計這一軌跡將繼續下去。當然，這將取決於市場動態。

And there are other factors as well that give us confidence that we can continue to improve our margins over time. A continued focus on innovation, and you will have heard from Costa at the start that our immunoglobin portfolio grew 17%, whilst our SCIG portfolio actually grew 19%. So that focus on innovation with CUVITRU and HYQVIA are continuing to increase contribution of our innovative IG portfolio. So the SCIG portfolio now represents 26% of total immunoglobin revenues and increasing over time.

還有其他因素讓我們有信心隨著時間的推移繼續提高利潤率。繼續專注於創新，您一開始就會從 Costa 那裡聽說我們的免疫球蛋白產品組合增長了 17%，而我們的 SCIG 產品組合實際上增長了 19%。因此，CUVITRU 和 HYQVIA 對創新的關注將繼續增加我們創新 IG 產品組合的貢獻。因此，SCIG 投資組合現在佔免疫球蛋白總收入的 26%，並且隨著時間的推移而增加。

And the other thing is continued focus on productivity and efficiency improvement right across the value chain from collection through fractionation, purification and distribution. So that's helping to improve our margins over time as well. Thank you for the question.

另一件事是繼續關注從收集到分餾、純化和分配的整個價值鏈的生產力和效率提高。因此，隨著時間的推移，這也有助於提高我們的利潤率。感謝你的提問。

Yes. So if I understood correctly, because you were breaking up, you just wanted to understand the reported operating profit growth for the full year guidance versus the first half of the year.

是的。因此，如果我理解正確，因為您要分手，您只是想了解報告的全年指導營業利潤增長與上半年相比。

So again, the main reason for the decline is coming from the one-off gain on the sale of the Japan diabetes portfolio last year in Q1. So every quarter that goes by, this gain from Q1 would unwind. So for example, if you look at our Q1 reported operating profit, that was declining close to 40%. Now in Q2, it's declining at minus 26%. And every quarter, that gap will start to come down. So you'll start to see the impact of that quarter 1 of last year gain for the sale of the diabetes portfolio because it's a onetime event, it will unwind for the full year. So that's something that you just need to keep an eye on.

同樣，下降的主要原因是去年第一季度出售日本糖尿病產品組合的一次性收益。因此，每過一個季度，第一季度的收益就會減少。因此，例如，如果您查看我們第一季度報告的營業利潤，則下降了近 40%。現在在第二季度，它以負 26% 的速度下降。每個季度，這種差距都會開始縮小。因此，您將開始看到去年第一季度銷售糖尿病產品組合的收益的影響，因為這是一次性事件，它將在全年結束。因此，您只需要注意這一點。

[Interpreted] Now next question is going to be the last question. We would like to conclude with the next question. The next question is from Nikkei BP, Hashimoto-san.

[解釋] 現在下一個問題將是最後一個問題。我們想以下一個問題結束。下一個問題來自日經 BP，橋本先生。

I'm Hashimoto from Nikkei BP. Do you hear me, okay?

我是日經 BP 的橋本。你聽我說，好嗎？

Yes.

是的。

I have two questions. First, about dengue vaccine. This is going to be the first global vaccine with high expectations. I do understand that, but it's taken 10 years. So why is it that it's taken so long? For any global vaccine, is that normal timeline? Or is it because of the difficulty specifically with dengue vaccine?

我有兩個問題。首先，關於登革熱疫苗。這將是第一個被寄予厚望的全球疫苗。我明白這一點，但它花了10年。那麼為什麼花了這麼長時間呢？對於任何全球疫苗，這是正常的時間表嗎？還是因為登革熱疫苗特別困難？

And Nuvaxovid, another vaccine. Omicron variant product is being developed by Novavax and they are going to file in the fourth quarter in Japan for Omicron variance, Nuvaxovid. Are you going to develop that for Omicron variance as well?

還有另一種疫苗 Nuvaxovid。 Omicron 變體產品由 Novavax 開發，他們將於第四季度在日本申請 Omicron 變體 Nuvaxovid。您是否也要為 Omicron 方差開發它？

Yes. Thank you, Hashimoto-san for the question of 10 years, but you need to understand that we had -- we generated 4.5 years efficacy data. So half -- in fact, half of the 10 years, it's about conducting the clinical trial and generating this 4.5 years. I think that's very important. That depends by disease, by vaccines. But normally, it's very important to have long-term efficacy data.

是的。謝謝橋本先生提出 10 年的問題，但您需要了解我們有 - 我們生成了 4.5 年的療效數據。所以一半——事實上，這 10 年的一半，是關於進行臨床試驗並產生這 4.5 年。我認為這非常重要。這取決於疾病和疫苗。但通常情況下，擁有長期療效數據非常重要。

There was an exception made for COVID vaccines, frankly, where because of the crisis, the world was satisfied with 6 months, but that's the exception. Normally, you have -- you need more long-term efficacy data. So that's what we generated. And 4.5 years is quite long. It's quite long. So that's just explained why it took overall 10 years to generate these vaccines.

坦率地說，對於 COVID 疫苗有一個例外，由於危機，世界對 6 個月感到滿意，但這是個例外。通常，您有 - 您需要更多的長期療效數據。這就是我們生成的。而4.5年相當長。它很長。所以這只是解釋了為什么生產這些疫苗需要 10 年的時間。

Dengue is also very complicated, because you have multiple serotype. And this is -- the infection gets more severe when you get more exposure. So it's actually a very tricky disease to protect again, and that's why we are so pleased with the results that we generated with these vaccines. Thank you.

登革熱也很複雜，因為你有多种血清型。這是 - 當你接觸更多時，感染會變得更嚴重。因此，再次保護它實際上是一種非常棘手的疾病，這就是我們對這些疫苗產生的結果如此滿意的原因。謝謝你。

[Interpreted] This is Iwasaki speaking. Thank you very much for your question, Hashimoto-san. So yes, we have been able to bring two vaccines to Japan to respond to the pandemic situation. We are contributing to the public health of this country. We are very proud of it, and we have a very strong sense of mission. And about Nuvaxovid, Omicron variant vaccines, as you have said at the outset of your question, overseas outside of Japan, Novavax is developing or considering developing Nuvaxovid for Omicron variant according to some reports.

[解釋] 這是岩崎先生說的。非常感謝您的提問，橋本先生。所以是的，我們已經能夠將兩種疫苗帶到日本來應對大流行情況。我們正在為這個國家的公共衛生做出貢獻。我們為此感到非常自豪，我們有非常強烈的使命感。關於 Nuvaxovid，Omicron 變體疫苗，正如您在問題開始時所說，在日本以外的海外，根據一些報導，Novavax 正在開發或考慮開髮用於 Omicron 變體的 Nuvaxovid。

As of now, in Japan, we don't have anything that we can disclose. But we will continue to monitor Novavax situation overseas, and we will have continued close cooperation and communication with PMDA and MHLW to consider whether we should be also developing Nuvaxovid for Omicron variants or not. Thank you very much, Hashimoto.

截至目前，在日本，我們沒有任何可以透露的信息。但我們將繼續關注海外 Novavax 的情況，我們將繼續與 PMDA 和 MHLW 保持密切合作和溝通，以考慮我們是否也應該為 Omicron 變體開發 Nuvaxovid。非常感謝你，橋本。

With this, we conclude the conference call for today. Thank you very much for taking time out of your busy schedule to attend today. If you have any individual questions, please contact our IR office. We look forward to your continued support. With this, we conclude the webinar. Thank you.

至此，我們結束了今天的電話會議。非常感謝您在百忙之中抽出時間出席今天的會議。如果您有任何個人問題，請聯繫我們的 IR 辦公室。我們期待您的繼續支持。至此，我們結束了網絡研討會。謝謝你。

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

[此成績單中標記為 [已翻譯] 的部分由現場通話中的口譯員朗讀。]