使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Thank you very much for joining us out of your busy schedule today for the Earnings Call for Second Quarter Fiscal 2023 with Takeda Pharmaceutical Company Limited.
[解讀]非常感謝您今天在百忙之中參加我們與武田藥品工業株式會社舉行的 2023 財年第二季度收益電話會議。
I am going to be the moderator today, O'Reilly, the Head of IR.
我將擔任今天的主持人,IR 主管 O'Reilly。
Now let me explain about language setting. At the bottom of the Zoom window, there is a language button. If you wish to listen to Japanese, please choose Japanese. And if you wish to listen to English, please choose English. If you just listen to live audio, please turn it off.
現在讓我解釋一下語言設定。在縮放視窗的底部,有一個語言按鈕。如果您想聽日語,請選擇日語。如果您想聽英語,請選擇英語。如果您只是聽現場音頻,請關閉它。
Before starting, I'd like to remind everyone that we will be discussing forward-looking statements within the meeting -- meaning of the Private Securities Legislation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings.
在開始之前,我想提醒大家,我們將在會議中討論前瞻性陳述 - 1995 年《私人證券立法改革法案》的含義。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。
Please also refer to the important notice on 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 to -- in the presentation.
另請參閱簡報第 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,這些資訊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較國際財務報告準則財務衡量標準的調整表包含在簡報的附錄中。
Let's get started with the presentation today. CEO and President, Christophe Weber; and President of R&D, Andy Plump; and Chief Financial Officer, Costa Saroukos, will be making presentations each. And then we will open the floor for questions. Let's get started. Christophe, over to you.
讓我們開始今天的示範。執行長兼總裁 Christophe Weber;兼研發總裁 Andy Plump;和財務長 Costa Saroukos 將分別發表演說。然後我們將開始提問。讓我們開始吧。克里斯托夫,交給你了。
Christophe Weber - President, CEO & Representative Director
Christophe Weber - President, CEO & Representative Director
Thank you, Chris. Thank you, everyone, for joining us today. It's a real pleasure to be with you all. At Takeda, our vision is to discover and deliver life-transforming treatments tailored by our commitment to patients, our people and the planet.
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。在武田,我們的願景是根據我們對患者、人民和地球的承諾,發現並提供量身定制的改變生命的治療方法。
This purpose-led approach is at the core of our strategy to deliver long-term value creation for our stakeholders. We are rapidly embracing the use of data, technology and AI transforming the company across all functions. We'll provide more details on this remarkable change next year.
這種以目的為導向的方法是我們為利害關係人創造長期價值的策略的核心。我們正在迅速採用數據、技術和人工智慧來改變公司的所有職能部門。我們將在明年提供有關這一顯著變化的更多詳細資訊。
Our performance in the first half of fiscal year 2023, while facing 2 setbacks with our pipeline further demonstrate our progress in executing on our strategy as we look to maximize our portfolio, advance our pipeline and deliver on our commitments.
我們在2023 財年上半年的業績雖然在管道方面面臨2 次挫折,但進一步證明了我們在執行策略方面取得的進展,因為我們希望最大限度地擴大我們的產品組合、推進我們的管道並兌現我們的承諾。
Turning to Slide 5, our first semester performance underscores the strength of our core business and our ability to deliver life transforming treatment to patients and communities.
轉向幻燈片 5,我們第一學期的表現強調了我們核心業務的實力以及我們為患者和社區提供改變生活的治療的能力。
Looking at our financial results. Revenue for the period was JPY 2.1 trillion or USD 14.1 billion. Year-over-year growth at a constant exchange rate was 1.4%, driven by momentum in our growth and launch product, which represents 42% of our total revenue, and grew at 13% at a constant exchange rate.
看看我們的財務表現。該期間收入為 2.1 兆日圓(141 億美元)。以固定匯率計算,年增 1.4%,這主要得益於我們的成長和推出產品的勢頭,該產品占我們總收入的 42%,按固定匯率計算,同比增長 13%。
At actual exchange rate, our top line growth was plus 6.4%. This top line growth is despite generics for VYVANSE launching in the U.S. after patent expiry in August. To date, the impact of generics and VYVANSE market share has been broadly in line with our expectations.
以實際匯率計算,我們的收入成長了 6.4%。儘管 VYVANSE 的仿製藥在 8 月專利到期後在美國上市,但營收仍實現了成長。迄今為止,仿製藥和 VYVANSE 市場份額的影響基本上符合我們的預期。
Core operating profit was JPY 588.8 billion or USD 3.9 billion with a decline versus prior year of 9.5%. The year-over-year decline is in line with expectation and reflect the impact of loss of exclusivity for higher-margin products, lower coronavirus vaccine demand, as well as our strategic investment in R&D and Data & Technology to ensure that Takeda long-term competitiveness.
核心營業利潤為 5,888 億日圓(39 億美元),較上年下降 9.5%。年比下降符合預期,反映了高利潤產品的獨家經營權喪失、冠狀病毒疫苗需求下降以及我們對研發和數據與技術的策略性投資的影響,以確保武田的長期發展競爭力。
Core EPS for the period was JPY 261. On a reported basis, operating profit and EPS were impacted by a large noncore item booked in the second quarter, including impairment of intangible assets related to EXKIVITY and ALOFISEL.
該期間的核心每股收益為 261 日圓。根據報告,營業利潤和每股收益受到第二季度登記的大型非核心項目的影響,包括與 EXKIVITY 和 ALOFISEL 相關的無形資產減損。
While very unfortunate for patients and material to the company, the 2 setbacks triggering these impairments don't impact our strategy for delivering a near-term return to growth and long-term sustainable value for shareholders. Costa will go into this item in more detail later in the presentation.
雖然對患者和公司來說非常不幸,但引發這些損害的兩次挫折並不會影響我們為股東提供短期成長回報和長期可持續價值的策略。 Costa 將在稍後的演示中更詳細地討論這個項目。
Turning to the outlook for the remainder of the fiscal year. We are raising full year revenue and core EPS forecast to reflect updated ForEx and tax rate assumptions. We are on track to our management guidance for core growth at a constant exchange rate, and there is no change to our guidance.
轉向本財年剩餘時間的前景。我們正在上調全年收入和核心每股收益預測,以反映更新的外匯和稅率假設。我們正在按固定匯率實現核心成長的管理指導,並且我們的指導沒有變化。
There is also no change to our full year free cash flow forecast of JPY 400 billion to JPY 500 billion. On a reported basis, we are lowering full year profit forecast due to the impact of the noncore item booked in the second quarter.
我們對全年自由現金流預測為 4000 億日元至 5000 億日元也沒有變化。根據報告,由於第二季預訂的非核心項目的影響,我們下調了全年利潤預測。
On Slide 6, we are advancing our innovative portfolio to reach new patient population, address unmet needs and provide new treatment options to improve patient outcomes and quality of life. Last month, we received FDA approval for the subcutaneous administration of ENTYVIO for maintenance therapy in moderate to severely active ulcerative colitis. This makes ENTYVIO the only FDA approved biologics in ulcerative colitis and offer patients a choice of 2 type of administration.
在投影片 6 中,我們正在推進我們的創新產品組合,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品質。上個月,我們獲得 FDA 批准皮下注射 ENTYVIO 用於中度至重度活動性潰瘍性結腸炎的維持治療。這使得 ENTYVIO 成為 FDA 唯一批准的治療潰瘍性結腸炎的生物製劑,並為患者提供 2 種給藥方式的選擇。
We expect ENTYVIO subcutaneous to be available in the U.S. by the end of October, and we are fully committed to the success of its launch.
我們預計 ENTYVIO 皮下注射將於 10 月底在美國上市,我們完全致力於上市的成功。
I will come back to ENTYVIO progress and growth outlook on the next slide. The FDA is also evaluating our application for subcutaneous administration of ENTYVIO for the treatment of Crohn's disease, and we expect a decision in the first half of fiscal year 2024.
我將在下一張投影片上回顧 ENTYVIO 的進展和成長前景。 FDA 也正在評估我們皮下注射 ENTYVIO 治療克隆氏症的申請,我們預計將在 2024 財年上半年做出決定。
Our dengue vaccine, QDENGA, continues to be recognized as a critical step forward in the fight against dengue fever. Last month, the WHO Strategic Advisory Group of Experts and Immunization recommended its use in high dengue burden and transmission areas for children aged 6 to 16, where it believes the vaccines will have the greatest public health impact.
我們的登革熱疫苗 QDENGA 繼續被認為是對抗登革熱的關鍵一步。上個月,世衛組織專家和免疫策略諮詢小組建議在登革熱高負擔和傳播地區針對 6 至 16 歲兒童使用該疫苗,認為該疫苗將在這些地區產生最大的公共衛生影響。
Other milestone in the first half of the year include approval of CUVITRU as our first subcutaneous immunoglobulin product in Japan, delivering on our commitment to reach patients with high unmet needs.
今年上半年的其他里程碑包括 CUVITRU 獲批准成為我們在日本的第一個皮下免疫球蛋白產品,兌現了我們對滿足高度未滿足需求的患者的承諾。
And in our oncology portfolio, ADCETRIS received a label extension in Europe for stage 3 patients as a first-line treatment for Hodgkin lymphoma. The approval was based on updated positive overall survival results from the Phase III EXCLAIM-1 study for stage 3 and 4 Hodgkin lymphoma, which demonstrated the first significant improvement in overall survival in 2 decades in stage 3 and 4 Hodgkin lymphoma.
在我們的腫瘤學產品組合中,ADCETRIS 在歐洲獲得了針對 3 期患者的標籤延期,作為霍奇金淋巴瘤的一線治療藥物。此次批准是基於針對3 期和4 期霍奇金淋巴瘤的III 期EXCLAIM-1 研究的更新的積極總體生存結果,該研究表明3 期和4 期霍奇金淋巴瘤的總體生存率在20年來首次顯著改善。
Moving to the right side of the slide to look at progress in our innovative pipeline. In September, we resubmitted TAK-721 to the U.S. FDA for the treatment for eosinophilic esophagitis. We expect a decision from the FDA during the first half of calendar year 2024.
移至幻燈片右側,查看我們創新管道的進度。 9月,我們向美國FDA重新提交TAK-721用於治療嗜酸性食道炎。我們預計 FDA 將在 2024 年上半年做出決定。
Also in September, we announced positive top line results from our Phase IIb trial of TAK-279 for active psoriatic arthritis. This is a significant milestone in our effort to develop a new treatment option for patients with this debilitating condition.
同樣在 9 月,我們宣布了 TAK-279 治療活動性乾癬性關節炎的 IIb 期試驗的積極結果。這是我們為患有這種衰弱疾病的患者開發新治療方案的努力中的一個重要里程碑。
We had a number of filing in Japan in the first half with fruquintinib 5 for previously treated metastatic colorectal cancer, and TAK-755 for cTTP. We are pleased to have entered an exclusive licensing agreement with ImmunoGen to develop and commercialize mirvetuximab for FRa-positive ovarian cancer in Japan.
上半年,我們在日本收到了多項用於治療既往治療的轉移性結直腸癌的呋喹替尼 5 和用於治療 cTTP 的 TAK-755 的申請。我們很高興與ImmunoGen 簽訂獨家授權協議,在日本開發和商業化用於治療FRa 陽性卵巢癌的mirvetuximab。
But we also faced some headwinds. In October, we made the voluntary decision to withdraw activity in the U.S. based on the outcome of the EXCLAIM-2 confirmatory trial and discussion with the FDA. We are discussing next steps with regulators in other countries where EXKIVITY is available as we intend to initiate voluntary withdrawal globally.
但我們也面臨一些阻力。 10 月份,根據 EXCLAIM-2 驗證性試驗的結果以及與 FDA 的討論,我們自願決定撤回在美國的活動。我們正在與可使用 EXKIVITY 的其他國家/地區的監管機構討論後續步驟,因為我們打算在全球範圍內啟動自願退出。
Patients are our top priority and EXKIVITY remains available to be prescribed in the U.S. while we work with the FDA to formally withdraw within an appropriate time frame. The withdrawal decision on time line outside of the U.S. will vary by country.
患者是我們的首要任務,EXKIVITY 仍然可以在美國開處方,同時我們與 FDA 合作,在適當的時間範圍內正式撤回。美國境外的提款決定時間因國家而異。
Also in October, we announced that the Phase III ADMIRE-CD II study of Alofisel for the treatment of complex Crohn's perianal fistula did not meet its primary end point. The study was designed to support a filing in the U.S., and we are currently evaluating next steps.
同樣在 10 月,我們宣布 Alofisel 用於治療複雜性克隆氏症肛門週瘺的 III 期 ADMIRE-CD II 研究未達到其主要終點。該研究旨在支持在美國提交申請,我們目前正在評估後續步驟。
Importantly, the safety profile was consistent with prior studies, and there were no new safety signals identified. These events highlight the inherent risk in research and development, but as a company focused on delivering life-transforming treatment to patients, we must continue to challenge ourselves at the forefront of innovation.
重要的是,安全性與先前的研究一致,並且沒有發現新的安全訊號。這些事件凸顯了研發的固有風險,但作為一家專注於為患者提供改變生命的治療的公司,我們必須繼續在創新的前沿挑戰自我。
Andy will speak further about our pipeline later in the presentation.
安迪將在稍後的演示中進一步討論我們的管道。
Turning now to ENTYVIO growth and outlook on Slide 7. In the first half of fiscal year '23, ENTYVIO continued its growth trajectory, increasing market share globally. In the U.S., ENTYVIO maintained the lead as #1 in inflammatory bowel disease overall as well as in IBD bio-naïve new starts.
現在轉向幻燈片 7 上的 ENTYVIO 成長和前景。在 23 財年上半年,ENTYVIO 繼續保持成長軌跡,增加了全球市場份額。在美國,ENTYVIO 在發炎性腸道疾病總體以及 IBD 生物新藥治療方面保持第一的領先地位。
Volume growth remained strong in the year in Europe at approximately 15%, outperforming the overall IBD advanced therapy market despite pricing headwinds.
儘管定價阻力,歐洲今年的銷售成長仍然強勁,約為 15%,表現優於整個 IBD 先進治療市場。
In the U.S., the IBD market is growing, but diagnosis and advanced therapy initiation remains suppressed compared with the 2016, 2019 period, so pre-COVID. Patient data suggest that new diagnosis still haven't recovered to pre-COVID level.
在美國,IBD 市場正在成長,但與 2016 年、2019 年期間(即新冠疫情之前)相比,診斷和高階治療啟動仍受到抑制。患者數據表明,新診斷仍未恢復至新冠疫情前的水平。
Nevertheless, the majority of moderate to severe patients remain untreated or on a conventional therapy, so we continue to see significant opportunities and our commercial organization is working very hard to expand our leadership in this area.
儘管如此,大多數中度至重度患者仍未得到治療或正在接受常規治療,因此我們繼續看到重大機會,我們的商業組織正在努力擴大我們在這一領域的領導地位。
Moving to the right side of the slide, our near and long-term growth catalysts. The U.S. approval of the subcutaneous administration for maintenance therapy in ulcerative colitis was a major milestone, making ENTYVIO the only FDA approved biologic in ulcerative colitis that offer patients a choice of 2 type of administration.
轉向幻燈片的右側,我們的近期和長期成長催化劑。美國批准皮下注射用於潰瘍性結腸炎的維持治療是一個重要的里程碑,使 ENTYVIO 成為 FDA 唯一批准的潰瘍性結腸炎生物製劑,為患者提供兩種給藥方式的選擇。
Subcutaneous therapies are estimated to represent approximately 35% to 40% of the total U.S. IBD market. So this is a very significant milestone that will allow us to access this new market segment.
據估計,皮下療法約占美國 IBD 市場總量的 35% 至 40%。因此,這是一個非常重要的里程碑,將使我們能夠進入這個新的細分市場。
We expect ENTYVIO Pen to be available in the U.S. by the end of October, and we are fully committed to the success of its launch.
我們預計 ENTYVIO Pen 將於 10 月底在美國上市,我們將全力支持其成功上市。
The FDA is also evaluating our application for subcutaneous administration of ENTYVIO for Crohn's disease. A decision is expected later this fiscal year.
FDA 也正在評估我們皮下注射 ENTYVIO 治療克隆氏症的申請。預計本財年晚些時候將做出決定。
We are pursuing new ongoing life cycle management to enhance long-term growth and making significant investments in both ulcerative colitis and Crohn's disease studies to support targets of disease clearance and transmural healing. And we are initiating new studies to support the scientific community to investigate the potential role of combination therapies to break the efficacy saving with vedolizumab as the backbone.
我們正在追求新的持續生命週期管理,以促進長期成長,並對潰瘍性結腸炎和克隆氏症研究進行大量投資,以支持疾病清除和透壁癒合的目標。我們正在啟動新的研究,以支持科學界調查聯合療法的潛在作用,以打破以維多珠單抗為支柱的療效節省。
Health care professionals and patients are continuing to see the benefit and value that ENTYVIO offer in IBD, and we remain confident with our peak revenue forecast at USD 7.5 billion to USD 9 billion with no change to biosimilar entry assumption timing potentially as late as 2032.
醫療保健專業人士和患者繼續看到ENTYVIO 在IBD 中提供的益處和價值,我們對75 億美元至90 億美元的峰值收入預測仍然充滿信心,生物仿製藥進入假設時間可能最遲到2032 年不會發生變化。
On Slide 8, QDENGA continues to be recognized as an important development in the fight against dengue fever. We are seeing strong initial demand in private market in endemic countries, as well as strong launches in travel market led by the EU.
在幻燈片 8 上,QDENGA 繼續被認為是對抗登革熱的重要進展。我們看到流行國家私人市場的初期需求強勁,以及以歐盟為首的旅遊市場的強勁推出。
This makes us optimistic, considering that public vaccination program has not started yet. QDENGA has already launched in dengue endemic countries, Indonesia, Brazil and Thailand, and recently received approval in Colombia. We expect launch in Argentina in the third quarter of this fiscal year.
考慮到公共疫苗接種計劃尚未開始,這讓我們感到樂觀。 QDENGA 已在登革熱流行國家印尼、巴西和泰國推出,最近在哥倫比亞獲得批准。我們預計本財年第三季在阿根廷推出。
The vaccine is available in 16 European countries, and travel recommendations support its use to help protect travelers to dengue endemic areas.
該疫苗在 16 個歐洲國家提供,旅行建議支持使用該疫苗來幫助保護前往登革熱流行地區的旅客。
And we are pursuing private and public partnership with government, institutional businesses, NGOs and manufacturers to expand access.
我們正在尋求與政府、機構企業、非政府組織和製造商建立私人和公共夥伴關係,以擴大准入。
Last month, the WHO Strategic Advisory Group of Expert on Immunization or SAGE recommended its use in high dengue burden and transmission area for children aged 6 to 16.
上個月,世界衛生組織免疫策略諮詢專家小組(SAGE)建議在登革熱高負擔和傳播地區的 6 至 16 歲兒童中使用該藥物。
SAGE assessed that the recommendation in this population would have the greatest public health impact as the vaccines could be administered to children prior to the time in which they are at the greatest likelihood of possible dengue-related hospitalization.
SAGE 評估認為,針對這一人群的建議將產生最大的公共衛生影響,因為可以在兒童最有可能因登革熱相關住院的時間之前給他們注射疫苗。
The evaluation was based on data from QDENGA clinical programs with more than 28,000 participants. The recommendation is significant because it will ultimately provide overarching guidance to countries around the world on how and when to implement vaccines into their public vaccination programs, and lay the foundation for access to vaccines worldwide, particularly in developing countries.
該評估基於 QDENGA 臨床計畫的數據,該計畫有超過 28,000 名參與者。這項建議意義重大,因為它將最終為世界各國提供關於如何以及何時將疫苗納入其公共疫苗接種計劃的總體指導,並為全世界尤其是發展中國家獲得疫苗奠定基礎。
In countries where QDENGA is ultimately approved, it is now up to national authorities to consider the size recommendation and decide how QDENGA should be used locally.
在 QDENGA 最終獲得批准的國家,現在由國家當局考慮規模建議並決定如何在當地使用 QDENGA。
Now I'd like to turn to our high-level outlook for the near, medium and long term. Our strategy remains on track as we enter the second half of the fiscal year. 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 products.
現在我想談談我們對近期、中期和長期的高層展望。當我們進入本財年下半年時,我們的策略仍然步入正軌。根據我們目前對 23 財年的假設,我們預計收入、利潤和利潤率將在短期內恢復成長,這主要是由我們的成長和推出產品的持續擴張所推動的。
We also see significant potential in our late-stage pipeline assets. We achieved significant data and regulatory milestones this year and anticipate a number of additional pipeline milestone in the second semester.
我們也看到了後期管道資產的巨大潛力。我們今年實現了重要的數據和監管里程碑,並預計第二學期將實現一些額外的里程碑。
Following generic competition for VYVANSE, which is impacting revenue and profit growth in this fiscal year and also in 2024, we will have limited loss of exclusivity exposure until the launch of ENTYVIO biosimilars, which could occur as late as 2032.
VYVANSE 的仿製藥競爭影響了本財年以及 2024 年的營收和利潤成長,在 ENTYVIO 生物相似藥推出之前(最晚可能在 2032 年推出),我們的獨家經營權損失將有限。
The momentum from our growth and launch product, combined with our continued investment in R&D will drive progress in the medium and long term. Looking ahead, we remain committed to returning to core operating profit margins in the low to mid-30s, supported by value creation enabled by Data & Technology, including AI.
我們的成長和推出產品的動力,加上我們對研發的持續投資,將推動中長期的進步。展望未來,在包括人工智慧在內的數據和技術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。
We will also continue to evaluate asset-specific business development opportunities to further enhance our pipeline and reinforce our growth profile.
我們也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管道並增強我們的成長前景。
Finally, our progressive dividend policy of increasing or maintaining the dividend each year will allow us to continue to return value to shareholders.
最後,我們每年增加或維持股利的漸進式股利政策將使我們能夠繼續為股東回報價值。
In closing, our strategy remains on track, and we are maintaining our management guidance for the full year. We continue to progress our pipeline and manage our on-market portfolio to create long-term value for our stakeholders, while we fulfill our purpose of bringing better health for people on the brighter future for the world.
最後,我們的策略仍然在正軌上,我們將維持全年的管理指導。我們繼續推進我們的產品線並管理我們的市場產品組合,為我們的利害關係人創造長期價值,同時我們實現為世界更光明的未來為人們帶來更好的健康的目標。
I will now pass it on to Andy to talk about our pipeline progress. Thank you.
我現在將其轉交給安迪,談談我們的管道進展。謝謝。
Andrew S. Plump - President of Research & Development and Representative Director
Andrew S. Plump - President of Research & Development and Representative Director
Thank you very much, Christophe, and big hello to everyone on today's call. Can we go to the next slide, please.
非常感謝克里斯托夫,並向參加今天電話會議的大家問好。我們可以轉到下一張投影片嗎?
We've made solid progress advancing our pipeline this quarter, as you just heard from Christophe. I'll take this opportunity to dive a bit deeper into several of the updates that Christophe just provided.
正如您剛剛從 Christophe 那裡聽到的那樣,我們本季在推進我們的產品線方面取得了紮實的進展。我將藉此機會更深入地了解 Christophe 剛剛提供的幾項更新。
TAK-279 read out positive Phase IIb data for the treatment of psoriatic arthritis. Based on these positive data, we will advance TAK-279 to a Phase III development program for psoriatic arthritis in fiscal year 2024. The full results will be presented at the meeting of the American College of Rheumatology in November as a late-breaker abstract.
TAK-279 讀出了治療乾癬性關節炎的 IIb 期陽性數據。基於這些積極的數據,我們將在 2024 財年將 TAK-279 推進到銀屑病關節炎的 III 期開發計劃。完整的結果將作為最新摘要在 11 月的美國風濕病學會會議上公佈。
The subcutaneous administration of ENTYVIO received a significant approval in the U.S. this quarter for maintenance therapy in adults with ulcerative colitis. This new route of administration provides an additional way for patients to benefit from ENTYVIO at home.
本季度,ENTYVIO 的皮下注射在美國獲得了重大批准,用於成人潰瘍性結腸炎的維持治療。這種新的給藥途徑為患者提供了一種在家中受益於 ENTYVIO 的額外方式。
ENTYVIO subcutaneous administration has also been filed for the treatment of adults with Crohn's disease in the U.S. and is currently under review by the FDA with potential approval in fiscal year 2024.
ENTYVIO 皮下注射也已在美國申請用於治療成人克隆氏症,目前正在接受 FDA 的審查,可能會在 2024 財年獲得批准。
In Japan, ENTYVIO subcutaneous administration is now available for both UC and Crohn's disease, following successful approvals in fiscal year 2023.
在日本,繼 2023 財年成功獲得批准後,ENTYVIO 皮下注射現已可用於治療 UC 和克隆氏症。
As you guys heard from Christophe, QDENGA received a very important recommendation from the World Health Organization's advisory group, endorsing public vaccination programs in countries with high dengue burden in children ages 6 to 16 years. We expect the WHO to update its guidelines shortly based upon these recommendations and look forward to continuing discussions with public health authorities in dengue-endemic countries.
正如你們從 Christophe 那裡聽到的那樣,QDENGA 收到了世界衛生組織諮詢小組的一項非常重要的建議,支持在 6 至 16 歲兒童登革熱負擔較高的國家開展公共疫苗接種計劃。我們預計世界衛生組織將根據這些建議盡快更新其指南,並期待與登革熱流行國家的公共衛生當局繼續討論。
The resubmission of TAK-721 for eosinophilic esophagitis, or EoE, to the FDA is an essential milestone for this program as well as for patients. I will describe the process that led to this filing later in the presentation.
TAK-721 治療嗜酸粒細胞性食道炎(EoE)重新向 FDA 提交對於該計畫以及患者來說是一個重要的里程碑。我將在稍後的演示中描述導致提交此文件的過程。
Momentum this quarter also came from 2 new additions to our pipeline. We licensed TAK-212 from AcuraStem.
本季的動力也來自我們管道中的 2 個新成員。我們從 AcuraStem 獲得了 TAK-212 的許可。
TAK-212 is an intrathecal antisense oligonucleotide targeting PIKFYVE for the treatment of Amyotrophic Lateral Sclerosis or ALS. We look forward to bringing this near IND-ready program to the clinic in the very near future.
TAK-212 是一種鞘內注射反義寡核苷酸,針對 PIKFYVE,用於治療肌萎縮性側索硬化症 (ALS)。我們期待在不久的將來將這個接近 IND 準備的計畫帶入臨床。
We also licensed from ImmunoGen Japan rights to mirvetuximab, a promising antibody-drug conjugate targeting folate receptor-alpha positive ovarian cancer.
我們也從ImmunoGen Japan 獲得了mirvetuximab 的權利,mirvetuximab 是一種針對葉酸受體-α 陽性卵巢癌的有前景的抗體藥物偶聯物。
In addition to these major updates, we also faced a couple of headwinds this past quarter. As Christophe just alluded to, we announced that ALOFISEL did not meet the primary endpoint in the ADMIRE II study.
除了這些重大更新之外,我們在上個季度還面臨一些阻力。正如 Christophe 剛才提到的,我們宣布 ALOFISEL 沒有達到 ADMIRE II 研究的主要終點。
The results are disappointing, particularly given the robust benefits previously demonstrated in the ADMIRE I Phase III study, which served as the basis for approval in Europe and Japan. We continue to believe in the benefits demonstrated by ALOFISEL in ADMIRE I, as well as in other trials such as the positive Japanese pivotal study and the inspire registry, an 800-patient European real world body of evidence.
結果令人失望,特別是考慮到先前在 ADMIRE I III 期研究中證明的強大益處,該研究是歐洲和日本批准的基礎。我們仍然相信 ALOFISEL 在 ADMIRE I 以及其他試驗中所展示的益處,例如積極的日本關鍵研究和 inform 登記處,這是一項包含 800 名患者的歐洲真實世界證據。
In addition, last quarter, we announced that the confirmatory trial for EXKIVITY in EGF receptor Exon20 insertion positive non-small cell lung cancer hit futility. We intend to initiate a global voluntary withdrawal of EXKIVITY. If we can go to the next slide, please.
此外,上個季度,我們宣布 EXKIVITY 在 EGF 受體 Exon20 插入陽性非小細胞肺癌中的驗證性試驗失敗。我們打算發起全球自願撤回 EXKIVITY。請轉到下一張投影片。
Depicted here are our exciting late-stage programs. TAK-279, our highest priority program, has posted the first in a series of Phase III protocols for psoriasis on clinicaltrials.gov and is on track to begin enrollment very soon. We believe that TAK-279 is a potential best-in-class oral therapy for psoriasis.
這裡描述的是我們令人興奮的後期專案。 TAK-279 是我們最優先的項目,已在 ClinicalTrials.gov 上發布了一系列銀屑病 III 期方案中的第一個,並有望很快開始招募。我們相信 TAK-279 是治療乾癬的潛在同類最佳口服療法。
As previously mentioned, based on the Phase IIb readout in psoriatic arthritis, we will move forward TAK-279 into a second pivotal Phase III development program early in fiscal year 2024. We're also accelerating development of TAK-279 in Crohn's disease, ulcerative colitis and systemic lupus erythematosus as well as exploring a range of other potential indications. These expansion opportunities are being developed in parallel with psoriasis and psoriatic arthritis.
如前所述,根據乾癬性關節炎的IIb 期結果,我們將在2024 財年年初將TAK-279 推進到第二個關鍵的III 期開發計劃。我們也正在加速TAK-279 在克羅恩病、潰瘍性結腸炎方面的開發結腸炎和系統性紅斑狼瘡,以及探索一系列其他潛在的適應症。這些擴張機會與銀屑病和銀屑病關節炎同時發展。
A new addition to the late-stage pipeline is now TAK-721, which was filed in the U.S. for EoE. And I'll talk about that on the next slide.
後期研發管線中的新成員是 TAK-721,已在美國提交 EoE 申請。我將在下一張幻燈片中討論這一點。
TAK-721 is a viscous topical steroids specifically designed to locally treat EoE. You can see on the right side of this slide, the significant responses at week 12 on both histology and symptoms, the co-primary endpoints of this pivotal trial. The clinical response in these patients started as early as week 4.
TAK-721 是一種黏性外用類固醇,專門設計用於局部治療 EoE。您可以在這張投影片的右側看到第 12 週時組織學和症狀的顯著反應,這是這項關鍵試驗的共同主要終點。這些患者的臨床反應早在第 4 週就開始出現。
There's a high unmet medical need in the U.S. for an oral treatment option that can act rapidly and locally in the esophagus. There's only 1 approved agent for EoE in the U.S., a systemic biologic that showed significant benefits at 24 weeks. The strong data and remaining unmet need in the U.S. for significant grassroot support for TAK-721 from the GI and EoE community. We have been collaborating with these communities to uncover additional benefits. We have now revised our NDA submission package with additional data analyses focused at week 12, and are cautiously optimistic for our filing of TAK-721 for the treatment of EoE. Next slide, please.
在美國,對於能夠在食道中快速局部發揮作用的口服治療方案的醫療需求尚未得到滿足。美國祇有 1 種批准用於 EoE 的藥物,這是一種全身性生物製劑,在 24 週時顯示出顯著的療效。美國 GI 和 EoE 社群對 TAK-721 的大力基層支持的強勁數據和尚未滿足的需求。我們一直在與這些社區合作,以發現更多好處。我們現在已經修改了 NDA 提交包,並在第 12 週進行了額外的數據分析,並對我們提交用於治療 EoE 的 TAK-721 的申請持謹慎樂觀態度。請下一張投影片。
Here, we show our promising mid-stage pipeline. We continue to be energized by recent developments in our Orexin franchise. We believe Orexin receptor 2 agonists have the potential to be the first agent to address the underlying cause of narcolepsy type 1, offering the potential for functional cures. TAK-861 has completed enrollment well ahead of schedule in 2 Phase IIb trials that started in January of 2023. Combined, the narcolepsy type 1 and type 2 Phase IIb trials have enrolled approximately 180 patients.
在這裡,我們展示了我們有前途的中期管道。我們繼續因 Orexin 特許經營權的最新發展而充滿活力。我們相信,Orexin 受體 2 激動劑有潛力成為第一個解決 1 型發作性睡病根本原因的藥物,並提供功能性治癒的潛力。 TAK-861 已提前完成 2023 年 1 月開始的 2 項 IIb 期試驗的入組工作。1 型和 2 型發作性睡病 IIb 期試驗合計已入組約 180 名患者。
TAK-861 is a more potent agent that may provide efficacy at a much lower dose than previously tested oral Orexin agonists significantly reduces the potential for adverse effects, including liver toxicity which tends to be dose related.
TAK-861 是一種更有效的藥物,與先前測試的口服 Orexin 激動劑相比,可以以低得多的劑量發揮功效,顯著降低潛在的不良反應,包括往往與劑量相關的肝毒性。
The external reviews conducted by the Drug Monitoring Committee confirmed that no liver toxicity signals have been observed. We continue to see nearly all patients who complete the trials enrolling in the long-term extension study, which can extend up to 102 weeks.
藥品監察委員會進行的外部審查證實,未觀察到肝毒性訊號。我們繼續看到幾乎所有完成試驗的患者都參加了長期擴展研究,該研究可以延長至 102 週。
We remain on track to make a final go/no-go decision to advance TAK-861 to Phase III in type 1 narcolepsy and type 2 narcolepsy in the first half of calendar year 2024.
我們仍有望做出最終的通過/不通過決定,在 2024 年上半年將 TAK-861 推進到 1 型發作性睡病和 2 型發作性睡病的 III 期臨床。
We are also on track to file an IND for our next-generation oral receptor 2 agonist -- oral Orexin receptor 2 agonist later this fiscal year. Additional oral Orexin receptor 2 agonists will allow us to expand into a range of more prevalent disorders with sleep wake cycle disruptions to fully explore the potential of these agents.
我們也有望在本財年稍後為我們的下一代口服受體 2 激動劑——口服食慾素受體 2 激動劑提交 IND 申請。額外的口服食慾素受體 2 激動劑將使我們能夠擴展到一系列更常見的睡眠覺醒週期紊亂疾病,以充分探索這些藥物的潛力。
Mezagitamab is our fully humanized anti-CD38 monoclonal antibody that has been studied across several rare autoimmune and inflammatory diseases. Mezagitamab depletes plasma cells, resulting in substantial and durable reduction of pathogenic immunoglobulins, leading to potentially meaningful improvements in IgG and IgA mediated autoimmune diseases.
Mezagitamab 是我們的全人源化抗 CD38 單株抗體,已針對多種罕見的自體免疫疾病和發炎性疾病進行了研究。 Mezagitamab 會消耗漿細胞,導致致病性免疫球蛋白大量且持久地減少,從而對 IgG 和 IgA 介導的自體免疫疾病產生潛在有意義的改善。
In addition, there is a suggestion that mezagitamab improves the rapidity of the clinical response in immune Thrombocytopenic Purpura or ITP by eliminating CD38-positive immune effector cells, which are directly responsible for platelet disruption.
此外,有人建議美札吉他單抗透過消除直接導致血小板破壞的 CD38 陽性免疫效應細胞,提高免疫性血小板減少性紫斑症或 ITP 的臨床反應速度。
Later this fiscal year, we are looking forward to emerging data in IgA nephropathy and IgA. If we can go to the next slide, please.
本財政年度晚些時候,我們期待 IgA 腎病和 IgA 的新數據。請轉到下一張投影片。
Here are select regulatory approvals and Phase III readouts for fiscal year 2023. In addition to the dates described previously for subcutaneous ENTYVIO and ALOFISEL, QDENGA received approval in Colombia this quarter. This is the fifth endemic country that has approved QDENGA.
以下是 2023 財年的部分監管批准和 III 期數據。除了先前描述的皮下注射 ENTYVIO 和 ALOFISEL 的日期外,QDENGA 本季度在哥倫比亞獲得了批准。這是批准 QDENGA 的第五個流行國家。
With the potential approval of TAK-721 later this fiscal year, we now have an opportunity to receive 3 new molecular entity approvals in the U.S. in fiscal year 2023. This next quarter, we expect to hear a decision in the U.S. about fruquintinib, our selective oral VEGF inhibitor for metastatic colorectal cancer. And we also expect to hear the FDA's response to our submission of TAK-755 and ADAMTS13 enzyme replacement therapy for the treatment of Congenital Thrombotic Thrombocytopenic Purpura or cTTP. Approval for this rare pediatric disease would fulfill a major unmet medical need.
隨著TAK-721 可能在本財年晚些時候獲得批准,我們現在有機會在2023 財年在美國獲得3 個新的分子實體批准。下個季度,我們預計將在美國聽到關於我們的呋喹替尼的決定。用於治療轉移性結直腸癌的選擇性口服 VEGF 抑制劑。我們也期望聽到 FDA 對我們提交的用於治療先天性血栓性血小板減少性紫斑症或 cTTP 的 TAK-755 和 ADAMTS13 酶替代療法的回應。這種罕見兒科疾病的批准將滿足一個重大的未滿足的醫療需求。
Thank you very much, and I will now turn it over to Costa.
非常感謝,我現在將其交給科斯塔。
Constantine Saroukos - CFO & Representative Director
Constantine Saroukos - CFO & Representative Director
Thank you, Andy, and hello, everyone. This is Costa Saroukos speaking. Today, I'll walk you through the financial highlights of our fiscal 2023 first half results.
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 財年上半年業績的財務亮點。
Starting with the top line. Revenue was JPY 2.1 trillion or USD 14.1 billion, delivering growth of 1.4% versus prior year at constant exchange rate, or 6.4% on an actual basis, including FX upside from the depreciation of the yen.
從頂線開始。營收為 2.1 兆日圓(141 億美元),以固定匯率計算較上年增長 1.4%,實際成長 6.4%(包括日圓貶值帶來的外匯上漲空間)。
Our top line performance was driven by our growth and launch products, which represents approximately 42% of total revenue and grew 13% at constant exchange rate.
我們的營收業績是由我們的成長和推出的產品推動的,該產品約佔總收入的 42%,按固定匯率計算增長了 13%。
Core operating profit was JPY 588.8 billion or USD 3.9 billion with a core operating profit margin of 28%. Reported operating profit was JPY 119.2 billion, reflecting the significant impact of noncash impairment losses and other noncore items that I will explain in the coming slides. Core EPS was JPY 261 and reported EPS was JPY 27, also impacted by several noncore items.
核心營業利益為 5,888 億日圓(39 億美元),核心營業利益率為 28%。報告的營業利潤為 1192 億日元,反映了非現金減損損失和其他非核心項目的重大影響,我將在接下來的幻燈片中對此進行解釋。核心每股收益為 261 日元,報告每股收益為 27 日元,也受到多個非核心項目的影響。
While many of these were headwinds to profit, we did book a positive tax gain in H1 as a result of our settlement with Irish revenue over the tax treatment of an acquisition break fee received by Shire in 2014.
雖然其中許多因素對利潤不利,但由於我們與愛爾蘭稅務局就 Shire 2014 年收到的收購終止費的稅務處理達成和解,我們在上半年確實獲得了正的稅收收益。
Moving to cash flow, we continue to see strong cash generation from the business, with operating cash flow of JPY 291.3 billion or $1.9 billion for the first half of the year.
轉向現金流,我們繼續看到該業務產生強勁的現金流,今年上半年的營運現金流為 2,913 億日圓(19 億美元)。
Free cash flow was minus JPY 71.1 billion, reflecting over JPY 250 billion of cash out for acquisitions and in-licensing so far this fiscal year, including the deals for TAK-279 and fruquintinib.
自由現金流為負 711 億日元,反映出本財年迄今用於收購和許可的現金支出超過 2500 億日元,其中包括 TAK-279 和 fruquintinib 的交易。
In Q2, we continue to make progress with debt reduction paying down USD 1 billion bond that matured in September. And we maintain a resilient financial base with 100% of outstanding debt at fixed interest rates with a weighted average rate of approximately 2%.
第二季度,我們繼續在債務削減方面取得進展,償還了9月到期的10億美元債券。我們維持著富有彈性的財務基礎,100% 的未償債務採用固定利率,加權平均利率約為 2%。
With regards to the outlook for full year fiscal 2023, we have made updates to our foreign exchange rate assumptions. And our reported forecast also reflects the impact of the large noncore items we booked in the first half that were not part of the original forecast.
關於 2023 財年全年前景,我們更新了外匯匯率假設。我們報告的預測也反映了我們在上半年預訂的大型非核心專案的影響,這些專案不屬於原始預測的一部分。
Importantly, we continue to track well towards our management guidance for performance at a constant exchange rate. Also, I want to emphasize that we are on track to delivering our full year free cash flow forecast of JPY 400 billion to JPY 500 billion.
重要的是,我們繼續以恆定匯率良好地追蹤我們的績效管理指導。此外,我想強調的是,我們預計將實現 4,000 億日圓至 5,000 億日圓的全年自由現金流預測。
On Slide 18, let me run through the details of our first half financial performance. Starting with our core results on the right of the slide. You can see that revenue was JPY 2.1 trillion with growth of 6.4% or 1.4% at a constant exchange rate, driven by our growth and launch products.
在投影片 18 上,讓我詳細介紹我們上半年的財務表現。從投影片右側的核心結果開始。您可以看到,在我們的成長和推出產品的推動下,營收為 2.1 兆日圓,成長 6.4%,以固定匯率計算成長 1.4%。
Core operating profit was JPY 588.8 billion, a decline of 5.8% on an actual FX basis, or 9.5% at constant exchange rate. This reflects the impact of generic competition for high-margin products such as VELCADE, DEXILANT and AZILVA, as well as lower COVID-19 vaccine revenue. There was also a core gross margin impact from the setbacks to EXKIVITY and ALOFISEL due to inventory write-off and impairment of manufacturing facilities.
核心營業利潤為 5,888 億日元,以實際匯率計算下降 5.8%,以固定匯率計算下降 9.5%。這反映了 VELCADE、DEXILANT 和 AZILVA 等高利潤產品仿製藥競爭的影響,以及 COVID-19 疫苗收入下降的影響。由於庫存沖銷和製造設施減值,EXKIVITY 和 ALOFISEL 的挫折也對核心毛利率產生了影響。
Meanwhile, we have continued to make the necessary investment in R&D and data and technology to secure the long-term success of the business.
同時,我們繼續在研發、數據和技術方面進行必要的投資,以確保業務的長期成功。
Core net profit and core EPS is impacted by a slightly higher core tax rate compared to last year, with core EPS for the first half of JPY 261, down 14.4% versus prior year at constant exchange rate.
核心淨利和核心每股盈餘受到核心稅率較去年略高的影響,上半年核心每股盈餘為261日圓,以固定匯率計算,較上年下降14.4%。
On the left-hand side, you can see our reported results. Reported revenue is the same as core revenue. Reported operating profit was significantly impacted by some large noncore items that we booked in Q2. This included JPY 115.8 billion of impairment of intangible assets, mainly related to the Phase III study readout of ALOFISEL and our voluntary global withdrawal of EXKIVITY.
在左側,您可以看到我們報告的結果。報告收入與核心收入相同。報告的營業利潤受到我們在第二季度預訂的一些大型非核心項目的顯著影響。其中包括1,158億日圓的無形資產減值,主要與ALOFISEL的III期研究結果和我們自願在全球撤回EXKIVITY有關。
We also booked higher restructuring expenses in the prior year and an additional legal provision, resulting in total other operating expenses of JPY 110.2 billion. These are reflected in our reported operating profit result of JPY 119.2 billion, a year-on-year decline of 53%.
我們還在上一年計入了更高的重組費用和額外的法律撥備,導致其他營運費用總額達到 1,102 億日圓。這些都反映在我們報告的營業利潤結果中,營業利潤為 1,192 億日元,年減 53%。
Reported net profit and reported EPS declined approximately 75%. Although we did book a JPY 63.5 billion tax benefit due to the settlement of a tax dispute with Irish revenue, our year-on-year net profit comparison was substantially impacted by onetime financial income booked in the first half of last year.
報告淨利潤和報告每股收益下降約 75%。儘管由於解決了與愛爾蘭收入的稅務糾紛,我們確實預訂了 635 億日元的稅收優惠,但我們的同比淨利潤比較受到去年上半年預訂的一次性財務收入的重大影響。
As highlighted on the previous slide, free cash flow reflected our cash payments for TAK-279 and fruquintinib, but there is no change to our full year forecast of JPY 400 billion to JPY 500 billion.
正如上一張投影片所強調的,自由現金流反映了我們對 TAK-279 和呋喹替尼的現金支付,但我們對全年 4000 億至 5000 億日元的預測沒有變化。
On Slide 19, I would like to highlight the performance of our growth and launch products, which are the key drivers of top line growth. These products generated 42% of total revenue in the first half, with 13% growth at constant exchange rate.
在投影片 19 上,我想強調我們的成長和推出產品的表現,它們是營收成長的關鍵驅動力。這些產品佔上半年總收入的42%,以固定匯率計算成長13%。
Within our 5 key business areas, GI grew plus 3% at constant exchange rate, a slowdown versus last year impacted by generic entry of DEXILANT in the U.S. in January this year.
在我們的 5 個關鍵業務領域中,GI 以固定匯率計算成長了 3%,與去年相比有所放緩,這是受到今年 1 月 DEXILANT 仿製藥進入美國的影響。
Our largest product, ENTYVIO, continues to perform well with growth of 6%, but remains a little behind where our expectations have been. As Christophe explained, there continues to be softness in the U.S. IBD market, and we are also being impacted by pricing headwinds in Europe.
我們最大的產品 ENTYVIO 繼續表現良好,成長了 6%,但仍略低於我們的預期。正如 Christophe 所解釋的那樣,美國 IBD 市場持續疲軟,我們也受到歐洲定價逆風的影響。
That said, we maintain the leading market share in the U.S. both in overall IBD prescriptions and in IBD bio-naïve new patient starts. And with approval last month of the subcutaneous device and ongoing investment in both marketing and life cycle management, we remain fully confident in the continued growth outlook for the product.
也就是說,我們在 IBD 整體處方和 IBD 生物新患者啟動方面都保持著美國領先的市場份額。隨著上個月皮下設備的批准以及對行銷和生命週期管理的持續投資,我們對該產品的持續成長前景仍然充滿信心。
In rare diseases, TAKHZYRO continues its strong momentum with growth of 13%, having successfully launched in over 50 countries and with sustained demand in the U.S. This has actually led us to raising our full year forecast for TAKHZYRO.
在罕見疾病領域,TAKHZYRO 持續保持強勁勢頭,成長 13%,已在 50 多個國家成功上市,美國市場需求持續成長。這實際上導致我們提高了對 TAKHZYRO 的全年預測。
We also see continued launch success for LIVTENCITY, up 83% with strong market penetration in the U.S. and rapid geographical expansion within Europe. PDT Immunology continues to deliver outstanding growth of 17%, including 19% growth of immunoglobulin and 11% growth of albumin.
我們也看到 LIVTENCITY 的推出持續取得成功,成長了 83%,在美國的市場滲透率強勁,在歐洲的地理擴張迅速。 PDT免疫學持續實現17%的優異成長,其中免疫球蛋白成長19%,白蛋白成長11%。
Both our IG and albumin products continue to see strong demand. We have continued to expand our plasma donation center network, adding 10 more centers in the first half of the year with the intent to increase by more than 20 new centers by the end of the fiscal year. And we have seen donor compensation on a downward trend since fiscal year 2022 after significant increases during the pandemic.
我們的 IG 和白蛋白產品的需求持續強勁。我們繼續擴大血漿捐贈中心網絡,上半年新增了 10 個中心,並計劃在本財政年度結束時增加 20 個以上新中心。我們發現,在疫情期間捐款者報酬大幅增加後,自 2022 財年以來,捐款者報酬呈下降趨勢。
We now modulate compensation in a highly segmented way while achieving the volumes to deliver on our commitments to our patients. Together with initiatives to improve efficiency across the PDT value chain, this has enabled us to improve PDT margins year-on-year for the first time since the pandemic.
我們現在以高度細分的方式調整薪酬,同時實現我們對病人的承諾。再加上提高整個 PDT 價值鏈效率的舉措,這使我們自疫情以來首次實現 PDT 利潤率較去年同期提高。
Next is oncology, which continues to decline as a result of VELCADE generics. However, the timing of loss of exclusivity in May 2022 means that the impact should wash out in the coming quarters. Excluding VELCADE, the rest of the portfolio grew 6%, driven by products such as ALUNBRIG, ADCETRIS and ICLUSIG.
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意味著影響應該會在未來幾季內消失。除了 VELCADE 外,在 ALUNBRIG、ADCETRIS 和 ICLUSIG 等產品的推動下,其餘產品組合成長了 6%。
EXKIVITY remains on this page for now, with H1 revenues of JPY 3.5 billion or approximately USD 25 million. We'll revisit our growth and launch categorization at the end of the fiscal year, taking into consideration the withdrawal of EXKIVITY, as well as potential new product launches we expect in the second half of the fiscal year.
EXKIVITY 目前仍保留在該頁面上,上半年營收為 35 億日圓(約 2,500 萬美元)。我們將在本財年末重新審視我們的成長並推出分類,考慮到 EXKIVITY 的退出,以及我們預計在本財年下半年可能推出的新產品。
Neuroscience grew at 3% in the first half of the year. We saw strong performance for VYVANSE in the first quarter, but as expected, we have seen several generic launch since the patent expired in August. To date, the generic erosion curve has been generally aligned with our initial estimates. We will continue to monitor the erosion trend and we'll communicate in future quarters if anything changes our outlook.
神經科學領域上半年成長 3%。我們在第一季看到了 VYVANSE 的強勁表現,但正如預期的那樣,自 8 月專利到期以來,我們已經看到了多個仿製藥的上市。迄今為止,通用侵蝕曲線與我們的初步估計基本一致。我們將繼續監控侵蝕趨勢,如果我們的前景發生任何變化,我們將在未來幾季進行溝通。
Finally, the other segment is declining in H1, mainly due to 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 has seen strong initial demand in both endemic and travel markets.
最後,上半年其他細分市場出現下滑,主要是因為日本 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,這是我們最新的成長和推出產品,在流行病和旅遊市場都出現了強勁的初始需求。
Over the next 3 slides, I'll walk you through some waterfalls to better explain the moving pieces in our first half performance versus prior year.
在接下來的 3 張投影片中,我將引導您瀏覽一些瀑布,以便更好地解釋我們上半年的表現與去年相比的變化。
Starting with revenue on Slide 20. You can see that versus prior year, our growth in launch products were the main driver of our 1.4% growth at constant exchange rate, more than offsetting the headwinds from loss of exclusivity and lower coronavirus vaccine revenue. On top of this, we had an FX tailwind due to the depreciation of the yen, taking our top line growth on an actual FX basis to 6.4%.
從幻燈片20 上的收入開始。您可以看到,與前一年相比,我們推出產品的增長是我們按固定匯率計算1.4% 增長的主要推動力,遠遠抵消了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。除此之外,由於日圓貶值,我們還獲得了外匯順風,使我們的實際外匯收入成長達到 6.4%。
Moving to the year-on-year core operating profit bridge on Slide 21. Here, you can see how loss of exclusivity and coronavirus vaccines are having a larger impact on profit compared to revenue due to the higher margins impacting our product mix. This mix was also impacted by some cost of goods expenses booked in H1 related to EXKIVITY inventory write-offs and manufacturing write-offs for ALOFISEL, both of which are treated as core expenses.
轉到幻燈片 21 上的同比核心營業利潤橋。在這裡,您可以看到排他性喪失和冠狀病毒疫苗對利潤的影響比收入更大,因為更高的利潤影響了我們的產品組合。這一組合也受到上半年記錄的一些與 EXKIVITY 庫存沖銷和 ALOFISEL 製造沖銷相關的商品成本費用的影響,這兩項費用均被視為核心費用。
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. R&D spend in the first half increased almost 10% on a constant exchange rate basis, but this reflects phasing as expected. And for the full year, we anticipate a mid-single-digit increase versus prior year.
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。以固定匯率計算,上半年研發支出成長了近 10%,但這反映了預期的階段性。對於全年而言,我們預計與去年相比將出現中個位數的成長。
We also continue to make substantial investment in Data and Technology, including AI across the value chain. 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.
我們也持續對數據和技術進行大量投資,包括整個價值鏈的人工智慧。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成長中發揮重要作用。
At the same time, we are applying strict cost discipline to reduce other OpEx versus prior year. I also want to draw your attention to FX, which is less favorable than the FX to revenue. And this is due to much of our expenses being in euros for cost of goods, and in U.S. dollars for R&D and other investments.
同時,我們正在實施嚴格的成本控制,以減少其他營運支出(與去年相比)。我還想提請您注意外匯,外匯對收入的影響不如外匯。這是因為我們大部分的費用以歐元計算商品成本,以美元計算研發和其他投資。
All these factors combined resulted in a first half core operating profit decline of 9.5% on a constant exchange rate basis, or 5.8% decline when factoring the FX.
所有這些因素綜合起來,導致上半年核心營業利潤以固定匯率計算下降了 9.5%,如果考慮外匯因素,則下降了 5.8%。
Next is Slide 22, which explains the major items impacting our reported operating profit versus previous year. Here, you can see the sizable increase in impairment of intangible assets, which totaled JPY 115.8 billion in the first half, mainly due to the negative Phase III study readout of ALOFISEL and the voluntary global withdrawal of EXKIVITY.
接下來是投影片 22,它解釋了影響我們報告的營業利潤與前一年相比的主要項目。在這裡,您可以看到無形資產減值大幅增加,上半年總計1158億日元,主要是由於ALOFISEL的III期研究結果為負面以及EXKIVITY在全球範圍內自願退出。
In addition to that, we had an increase in other operating expenses. This included higher restructuring costs related to exiting AAV gene therapy and consolidating our office footprint. It also includes an additional legal provision booked this year. All these items combined led to the reported operating profit decline of 53.2%.
除此之外,我們的其他營運費用也有所增加。這包括與退出 AAV 基因治療和鞏固我們的辦公室足跡相關的更高的重組成本。它還包括今年預訂的額外法律條款。所有這些項目加起來導致報告的營業利潤下降 53.2%。
Moving to Slide 23 and our outlook for full year fiscal 2023. Based on the first half results, we do not see the need to make any changes to our management guidance at this stage. To date, the generic erosion of VYVANSE and AZILVA has been in line with our original expectations, and therefore, we are keeping our management guidance unchanged. Low single-digit percentage decline in revenue, low 10 percentage decline in core operating profit, and low 20s percentage decline in core EPS or on a constant exchange rate basis.
轉向投影片 23 和我們對 2023 財年全年的展望。根據上半年的業績,我們認為現階段沒有必要對我們的管理指導進行任何改變。迄今為止,VYVANSE 和 AZILVA 的一般侵蝕符合我們最初的預期,因此,我們維持管理指引不變。營收下降幅度較小,核心營業利潤下降幅度較小,為 10%;核心每股盈餘下降幅度較小,以固定匯率計算為 20%。
With regard to the reported and core forecast on an actual FX basis, we have updated our FX assumptions, resulting in a JPY 140 billion increase in our revenue forecast to JPY 3.98 trillion.
關於基於實際外匯的報告和核心預測,我們更新了外匯假設,導致我們的收入預測增加 1,400 億日元,達到 3.98 兆日元。
Reported operating profit and reported EPS forecast have been revised to incorporate the large noncore items that we booked in the first half. On a core basis, our core operating profit forecast is unchanged at JPY 1.015 trillion, with very small upside from FX being offset by product mix, including the cost of goods impact from EXKIVITY and ALOFISEL that I mentioned earlier.
報告的營業利潤和報告的每股盈餘預測已進行修訂,以納入我們上半年預訂的大型非核心項目。在核心基礎上,我們的核心營業利潤預測保持在 1.015 兆日圓不變,外匯帶來的微小上漲被產品組合所抵消,包括我之前提到的 EXKIVITY 和 ALOFISEL 的商品成本影響。
Core EPS is now projected to be JPY 447, an increase from our prior forecast due to a lower assumed core tax rate. Our free cash flow forecast is unchanged at JPY 400 billion to JPY 500 billion, and we remain committed to paying an annual dividend of JPY 188.
由於假設的核心稅率較低,核心每股盈餘目前預計為 447 日元,高於我們先前的預測。我們的自由現金流預測維持在 4,000 億日圓至 5,000 億日圓不變,我們仍致力於支付 188 日圓的年度股利。
To close out the presentation on Slide 24, I'd like to reemphasize that total company performance on a core basis is in line with expectations, and we are making steady progress towards our management guidance.
在投影片 24 的簡報結束時,我想再次強調,公司的整體核心業績符合預期,我們正在朝著管理指導方向穩步前進。
There were some large noncore items impacting our reported operating profit in the first half, but these do not derail our strategy. The loss of exclusivity headwinds we face in 2023 are as expected, and we have been preparing for this for many years. We have confidence in our portfolio and pipeline to deliver a return to growth in the near term, and we will continue to allocate capital with discipline as we focus on delivering sustainable growth and competitive shareholder returns.
有一些大型非核心項目影響了我們上半年報告的營業利潤,但這些並沒有破壞我們的策略。我們在 2023 年面臨的獨家經營權喪失的逆風正如預期的那樣,我們已經為此準備了很多年。我們對我們的投資組合和管道在短期內實現成長回報充滿信心,我們將繼續嚴格分配資本,專注於實現可持續成長和有競爭力的股東回報。
Finally, on Slide 25, I would like to highlight our upcoming IR events, including a plasma-derived therapies meeting in early December. I hope that many of you are able to participate for a deeper dive into this important business unit for Takeda.
最後,在投影片 25 上,我想強調我們即將舉行的 IR 活動,包括 12 月初舉行的血漿衍生療法會議。我希望你們中的許多人能夠參與其中,更深入地了解武田的這個重要業務部門。
Thank you for your attention, and we can now open it up for Q&A.
感謝您的關注,我們現在可以開放問答。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Now until 7:15 p.m. Japan time, we'd like to entertain your question. Christophe, Costa and Andy will answer. Additionally, Ramona Sequeira, President of Global Portfolio Division; Julie Kim, President of U.S. Business Unit; and Furuta Milano, President of Japan Pharma Business Unit. (Operator Instructions)
【解讀】即日起至晚上7點15分日本時間,我們願意回答您的問題。克里斯托夫、科斯塔和安迪將回答。此外,Ramona Sequeira,全球投資組合部總裁; Julie Kim,美國業務部總裁;和日本製藥事業部總裁 Furuta Milano。 (操作員說明)
First question from Citi, Yamaguchi-san.
山口先生,花旗提出第一個問題。
Hidemaru Yamaguchi - Research Analyst
Hidemaru Yamaguchi - Research Analyst
So this is Yamaguchi from Citi. I have 2 questions. The first question is that, regarding margin for Q2. I understand there are lots of exclusivities happening, but the currency is positive, the PDT is doing good. And -- but R&D goes up. So margin of the Q3 is around 25%. So which sounds below compared to Q1.
這是花旗銀行的山口。我有 2 個問題。第一個問題是關於第二季的利潤率。我知道有很多排他性的事情發生,但貨幣是正面的,PDT 表現良好。而且——但是研發增加了。因此第三季的利潤率約為 25%。與第一季相比,這聽起來更低。
So do you think this is lower than your expectation as far as Q3 is concerned or not? So that's the first question.
那麼您認為就第三季而言,這是否低於您的預期?這是第一個問題。
A second question, you mentioned about the PDT margin is getting better first time after COVID. What do you think -- what do you mean by the PDT margin? This operating margin you're talking about or Q1 or Q2 or first half compared to last year? Can you elaborate what is doing better on your PDT margin, which one are the crucial backstop for next fiscal year?
第二個問題,您提到 PDT 裕度在新冠疫情後第一次變得更好。您認為 PDT 裕度是什麼意思?您所說的營業利潤率是第一季、第二季還是上半年與去年比較?您能否詳細說明您的 PDT 利潤率在哪些方面做得更好,哪些是下一財年的關鍵支援?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
Okay. Yamaguchi-san. So a question on the margins and also on PDT margins specifically. So I'd like to ask Costa to respond to those questions.
好的。山口先生。這是一個關於邊際以及 PDT 邊際的問題。所以我想請科斯塔回答這些問題。
Constantine Saroukos - CFO & Representative Director
Constantine Saroukos - CFO & Representative Director
Right. Thank you. Yamaguchi-san, thank you for your question. You specifically asked for Q2 itself. So let me just walk you through the changes to the margin question for Q2. So Q2 core gross margin had declined for the quarter, mainly because of 2 reasons. One, as you highlighted already, the product mix. So we saw lots of exclusivity of high-margin products such as DEXILANT, VELCADE, AZILVA coupled with lower COVID vaccine revenue versus last Q2 fiscal year 2022.
正確的。謝謝。山口先生,謝謝你的提問。您專門詢問了 Q2 本身。那麼,讓我向您介紹一下第二季保證金問題的變化。因此,第二季核心毛利率下降,主要有兩個原因。一,正如您已經強調的,產品組合。因此,我們看到 DEXILANT、VELCADE、AZILVA 等許多高利潤產品的排他性,以及與 2022 財年第二季相比較低的新冠疫苗收入。
In addition to that, we saw cost of goods impact of ALOFISEL and EXKIVITY write-offs due to the setbacks that we had. So that put pressure on our margin for quarter 2 -- our gross profit margin.
除此之外,由於我們遇到的挫折,我們也看到了 ALOFISEL 和 EXKIVITY 沖銷對商品成本的影響。因此,這給我們第二季的利潤率——毛利率——帶來了壓力。
On our core operating profit margin. On top of the product mix, COVID vaccine and COGS impact, we had R&D phasing, so we had a ramp-up of R&D expenses, but this is phasing, and it's aligned to our forecast. And in addition to that, we did see some wind-down costs due to EXKIVITY.
關於我們的核心營業利潤率。除了產品組合、新冠疫苗和銷貨成本的影響之外,我們還進行了研發分階段,因此我們的研發費用有所增加,但這是分階段的,並且與我們的預測一致。除此之外,我們確實看到了由於 EXKIVITY 而導致的一些逐步減少的成本。
But nevertheless, on a year-to-date basis, we're tracking aligned to our plan, which is 28% core operating profit. As a total full year perspective, we're targeting JPY 1,015 billion. Again, second year in a row that we exceed JPY 1 trillion for Takeda on a core operating profit and year-to-date on a run rate, we're very much on track to delivering that full year target. So thank you very much on that question.
但儘管如此,從年初至今來看,我們的目標與我們的計劃保持一致,即 28% 的核心營業利潤。從全年來看,我們的目標是 10,150 億日圓。武田的核心營業利潤和年初至今的運行率連續第二年超過 1 兆日元,我們非常有望實現全年目標。非常感謝你回答這個問題。
On the PDT margin, what's improving, it's gross profit margin is improving, as well as core operating profit is improving. So we're seeing the gross profit margin improving mainly because of product mix within the portfolio. But on the core operating profit margin, we're seeing significant improvements overall, driven by a really efficient end-to-end process, whether it's leveraging data digital technology throughout the PDT value chain or manufacturing capacity.
就PDT利潤率而言,正在改善的是毛利率正在改善,核心營業利潤也在改善。因此,我們看到毛利率的改善主要是由於投資組合中的產品組合。但在核心營業利潤率方面,我們看到整體顯著改善,這是由真正高效的端到端流程推動的,無論是在整個 PDT 價值鏈中利用數據數位技術還是製造能力。
So overall, we're very pleased with the performance, not only on the top line growth for PDT, but also on its profitability. And this is something that we expect to continue for many years to come.
因此,總的來說,我們對業績非常滿意,不僅是 PDT 的營收成長,還有其獲利能力。我們預計這種情況將持續多年。
Hidemaru Yamaguchi - Research Analyst
Hidemaru Yamaguchi - Research Analyst
Sorry, quick -- 1 quick update on PDT. Talk about half of Q2 or Q1?
抱歉,快點 - PDT 上有 1 次快速更新。談論Q2或Q1的一半?
Constantine Saroukos - CFO & Representative Director
Constantine Saroukos - CFO & Representative Director
This is year-to-date. So, I am looking at first 6 months.
這是今年迄今的情況。所以,我正在關注前 6 個月。
Hidemaru Yamaguchi - Research Analyst
Hidemaru Yamaguchi - Research Analyst
Year-to-date, so first half.
今年迄今,上半年。
Constantine Saroukos - CFO & Representative Director
Constantine Saroukos - CFO & Representative Director
Yes, year-to-date, first 6 months.
是的,今年至今的前 6 個月。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Next question, Muraoka-san from Morgan Stanley.
[解讀]下一個問題,來自摩根士丹利的Muraoka-san。
Shinichiro Muraoka - Research Analyst
Shinichiro Muraoka - Research Analyst
[Interpreted] This is Muraoka from Morgan Stanley. I hope you can hear me.
[解說] 我是摩根士丹利的村岡。我希望你能聽到我的聲音。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Yes, we can hear you.
[翻譯] 是的,我們聽得到你的聲音。
Shinichiro Muraoka - Research Analyst
Shinichiro Muraoka - Research Analyst
[Interpreted] So recovery to growth from next fiscal year, I think this message was repeated several times today. And this year, VYVANSE was maybe a little bit too good. So for the next fiscal year, I cannot really imagine you growing the revenues in the next fiscal year. But are you confident? It looks like you're very confident that you can go back to growth in terms of revenues. Is that the correct understanding?
[解讀]所以從下個財年開始恢復成長,我認為這個消息今天已經重複了好幾次了。今年,VYVANSE 的表現可能有點太好了。因此,對於下一個財年,我真的無法想像你在下一個財年會增加收入。但你有信心嗎?看來您對收入恢復成長非常有信心。這是正確的理解嗎?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
To answer a question about our return to growth. So I'd like to ask Christophe to answer this one.
回答有關我們恢復成長的問題。所以我想請 Christophe 來回答這個問題。
Christophe Weber - President, CEO & Representative Director
Christophe Weber - President, CEO & Representative Director
Thank you, Muraoka-san. This return to growth will happen in 2024 or 2025. That's why we are seeing in the net '24, '25. We might be able to return to growth in '24, but in any case, it will be very, very tight. It's very clear in '25, but in '24, it will depend on how the '23 happen fully with VYVANSE especially generic erosion. So far, it's happening as planned, but things can fluctuate quite a bit.
謝謝你,村岡同學。這種成長的恢復將在 2024 年或 2025 年發生。這就是我們在網路「24」、「25」中看到的原因。我們也許能夠在 24 年恢復成長,但無論如何,成長將非常非常緊張。這在 25 年非常清楚,但在 24 年,這將取決於 23 年如何充分發生 VYVANSE,特別是通用侵蝕。到目前為止,一切都按計劃進行,但事情可能會有很大波動。
So in the near term, we are very clear that we will return to growth. Will it happen in '24 or '25, we'll have to see. If it happens in '24, it's possible, but it will be very tight.
因此,在短期內,我們非常清楚我們將恢復成長。它會在 24 年還是 25 年發生,我們拭目以待。如果發生在24年,那是有可能的,但時間會非常緊張。
Shinichiro Muraoka - Research Analyst
Shinichiro Muraoka - Research Analyst
[Interpreted] I forgot to mention my second question. Is it okay to ask it now?
[解讀]我忘了說我的第二個問題了。現在問可以嗎?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Yes, of course.
[解釋] 是的,當然。
Shinichiro Muraoka - Research Analyst
Shinichiro Muraoka - Research Analyst
[Interpreted] Slide 14. So this is the pipeline and proof of concept readout for FY '24. I can see 4 items listed here. And in the sequence of time, which one will be read out first, which is second, so on and so forth?
[解釋]投影片 14。這是 24 財年的流程和概念證明。我可以看到這裡列出了 4 個項目。並且依照時間順序,先讀出哪一個,再讀出哪一個,以此類推?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
The 2024 readouts, any more color on the timing within FY '24 for these 4 important readouts.
2024 年的讀數,以及 24 財年這 4 個重要讀數的時間安排上的更多資訊。
Andrew S. Plump - President of Research & Development and Representative Director
Andrew S. Plump - President of Research & Development and Representative Director
So Chris, it's Andy. Muraoka-san, thank you. So the first readouts that will come from these data will be in our Orexin program for TAK-861 for both type 1 narcolepsy and type 2 narcolepsy. And those will have final data for both studies in early 2024. We've actually completed enrollment of the -- of both of those Phase IIb studies. It's an 8-week primary endpoint for the study with the transition to an open label extension.
克里斯,是安迪。村岡同學,謝謝你。因此,這些數據的第一個讀數將出現在我們針對 1 型嗜睡症和 2 型嗜睡症的 TAK-861 的 Orexin 程序中。這些將在 2024 年初獲得這兩項研究的最終數據。我們實際上已經完成了這兩項 IIb 期研究的招募。這是該研究的一個為期 8 週的主要終點,並過渡到開放標籤擴展。
I'll say that we're already planning for Phase III at risk. We're planning for a successful data from those studies based on everything that we know. So those would be the first that will come.
我想說的是,我們已經在計畫第三階段的風險了。我們正在根據我們所知道的一切,計劃從這些研究中獲得成功的數據。所以這些會是第一個出現的。
We also expect to see data later this fiscal year for mezagitamab in ITP, and then early in fiscal year 2024 for IgA nephropathy. And then the remaining read outs will come later in the year.
我們也預計將在本財年稍後看到 mezagitamab 治療 ITP 的數據,然後在 2024 財年年初看到 IgA 腎病的數據。其餘的讀數將在今年稍後公佈。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Moving on to the next question. Next is Mr. Wakao from JPMorgan.
[解釋]繼續下一個問題。接下來是摩根大通的若尾先生。
Seiji Wakao - VP
Seiji Wakao - VP
[Interpreted] I'm Wakao from JPMorgan. I have 2 questions about ENTYVIO. The first one, ENTYVIO next fiscal year's forecast, with regard to this fiscal year, the revenue plan was revised downward. But looking at the situation next fiscal year, are we supposed to be more cautious? Or from next fiscal year, SC contribution will be there, and you will be on the recovery trend. Is that how we look at it? And that's the first question.
[翻譯]我是來自摩根大通的Wakao。我有 2 個關於 ENTYVIO 的問題。第一個,ENTYVIO下財年的預測,針對本財年,營收計畫向下修正。但從下個財年的情況來看,我們是否應該更加謹慎?或者從下一個財年開始,SC 貢獻將會存在,你將處於復甦趨勢。我們是這樣看的嗎?這是第一個問題。
And secondly, I would like to be informed of the most recent performance of ENTYVIO. You explained a lot, but what about the competitive landscape? You didn't mention any competitors. So there is intense competition, and they are doing marketing proactively. So is there -- has there been any change in the competitive landscape?
其次,我想了解ENTYVIO最近的表現。你解釋了很多,但是競爭格局呢?你沒有提到任何競爭對手。所以競爭很激烈,他們也積極主動地做行銷。那麼競爭格局是否發生了變化?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
So some questions on ENTYVIO, specifically the outlook for next year, expectations for subcutaneous and then some more detail on what we're seeing on the ground, including competition.
關於 ENTYVIO 的一些問題,特別是明年的前景、對皮下注射的期望,以及我們在實地看到的更多細節,包括競爭。
So I'd like to ask that Christophe to a couple of comments at the beginning, and then maybe hand over to Julie to give more detail, particularly on the U.S. market.
因此,我想在開始時請 Christophe 發表一些評論,然後可能會交給 Julie 提供更多細節,特別是關於美國市場的細節。
Christophe Weber - President, CEO & Representative Director
Christophe Weber - President, CEO & Representative Director
Okay. Thank you, Wakao-san, I think we, obviously, will give next year guidance in May next year. But I think there are very 2 important parameters that are important to consider.
好的。謝謝你,Wakao-san,我想我們顯然會在明年五月給出明年的指導。但我認為有兩個非常重要的參數要考慮。
One is that the launch of the subcu will certainly deleverage overall. And so we expect a very significant positive impact on the overall brand. I mentioned earlier that around 35% to 40% of the U.S. market is a subcu formulation market. So it will allow us to compete in this segment that we didn't have access to in the past. So that's one.
一是subcu的推出一定會整體去槓桿。因此,我們預計會對整個品牌產生非常重大的正面影響。我之前提到過,大約 35% 到 40% 的美國市場是 subcu 配方市場。因此,這將使我們能夠在過去無法進入的這個領域中競爭。這就是其中之一。
And two, it will be very interesting to see how the overall market is evolving. We believe that new patient treatment initiation is still quite low. The market growth in volume has been quite lower than what we expected. We know that we are not at the pre-COVID in terms of new treatment initiations. It would be very interesting to see if things will remain like that and we will see a rebound. So overall, I would suspect that we will see an increased growth.
第二,觀察整個市場如何演變將是非常有趣的。我們認為新患者開始治療的比例仍然很低。市場銷售成長遠低於我們的預期。我們知道,就新的治療啟動而言,我們還沒有處於新冠疫情之前。看看情況是否會保持這樣並且我們會看到反彈,這將是非常有趣的。總的來說,我懷疑我們會看到成長。
I will let Julie mention the situation and the competition. Obviously, there is a lot of competition. We can zoom on the U.S. But before that, I would like to mention that ENTYVIO is also growing very well outside of the U.S., in Europe, in China, in Japan.
我會讓朱莉提一下情況和競爭。顯然,競爭非常激烈。我們可以把重點放在美國,但在此之前,我想提一下,ENTYVIO 在美國以外、歐洲、中國、日本也發展得非常好。
Julie, perhaps you can comment on the competition?
朱莉,也許你可以對比賽發表評論?
Julie Kim - President of the U.S. Business Unit & U.S. Country Head
Julie Kim - President of the U.S. Business Unit & U.S. Country Head
Yes. Thanks, Christophe. And thank you for the question, Wakao-san. In terms of the competition in the U.S., as you've rightly pointed out, there is increased competition through new entrants. And even yesterday, there was an announcement of a new entrant from South Tryon.
是的。謝謝,克里斯托夫。謝謝你的提問,若尾先生。就美國的競爭而言,正如您正確指出的那樣,新進入者的競爭加劇了。甚至在昨天,就宣布了來自南特賴恩的新加入者。
So we continue to see multiple different mechanisms of actions entering into the IBD space. But ENTYVIO continues to be the only gut-selective MOA, and it continues to be a market share leader in terms of overall bio-naïve share as well as overall IBD market share.
因此,我們繼續看到多種不同的作用機制進入 IBD 領域。但 ENTYVIO 仍然是唯一的腸道選擇性 MOA,並且就整體生物製劑份額以及整體 IBD 市場份額而言,它仍然是市場份額的領導者。
So this is an area where we will continue to emphasize the benefits of ENTYVIO in the IBD space.
因此,這是我們將繼續強調 ENTYVIO 在 IBD 領域的優勢的一個領域。
And with the launch of the subcutaneous formulation ENTYVIO Pen, we're quite confident in our ability to continue to support ENTYVIO growth in the U.S. despite new entrants coming in.
隨著皮下製劑 ENTYVIO Pen 的推出,儘管有新進者進入,我們對繼續支持 ENTYVIO 在美國成長的能力充滿信心。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Next question from Jefferies, Steve Barker-san.
[解釋]傑弗里斯的下一個問題是史蒂夫·巴克桑。
Stephen Barker - Equity Analyst
Stephen Barker - Equity Analyst
Yes, Steve Barker here. I have 2 questions for Andy related to your narcolepsy candidate, TAK-861. Specifically, I wanted to ask about the Phase I results that were presented at World Sleep this week.
是的,史蒂夫·巴克在這裡。我有 2 個與您的發作性睡病候選人 TAK-861 相關的問題要問 Andy。具體來說,我想詢問本週在世界睡眠大會上公佈的第一階段結果。
Firstly, could you discuss the doses that were tested in Phase I in the context of the Phase II program?
首先,您能否在第二階段計劃的背景下討論第一階段測試的劑量?
And secondly, are you concerned that TAK-861 might be at a commercial disadvantage if it needs to be dosed twice per day. The context of the second question is, of course, the data presented on the Alkermes Orexin agonist, which looks like it can be developed as a once per day therapy.
其次,您是否擔心如果 TAK-861 需要每天服用兩次,它可能會處於商業劣勢。當然,第二個問題的背景是 Alkermes Orexin 激動劑的數據,該藥物看起來可以開發為每天一次的療法。
Andrew S. Plump - President of Research & Development and Representative Director
Andrew S. Plump - President of Research & Development and Representative Director
Stephen, I'll take the first question, and then I'll ask Ramona to chime in if she can on the commercial positioning of a once versus a twice daily dosing.
史蒂芬,我會回答第一個問題,然後我會請雷蒙娜插話,如果她可以的話,請談談每日一次和兩次給藥的商業定位。
So the Phase Ib data that we presented at the Sleep conference just this week, was really very small numbers, really proof of concept. The doses that we've used in our Phase IIb studies are significantly lower than what you saw this week.
因此,我們在本週的睡眠會議上展示的 Ib 期數據確實是非常小的數字,確實是概念證明。我們在 IIb 期研究中使用的劑量明顯低於您本週看到的劑量。
And then lastly, I'll say that we haven't decided on our dosing regimen yet for our Phase III program. That's something that we'll decide after we see our full Phase IIb data. And I think that we have to be cautious when we're looking at any data set, ours or competitors, from small Phase Ib studies in terms of understanding what administration schedules will look like. Ramona?
最後,我要說的是,我們尚未決定 III 期計畫的給藥方案。這是我們在看到完整的 IIb 期數據後才會做出的決定。我認為,當我們查看來自小型 Ib 期研究的任何數據集(無論是我們的數據集還是競爭對手的數據集)時,我們必須保持謹慎,以了解給藥時間表的情況。雷蒙娜?
Ramona Sequeira - President of Global Portfolio Division
Ramona Sequeira - President of Global Portfolio Division
Yes, Andy, I can chime in on the efficacy. And we had a very large team at the Sleep conference this week and are very excited about the Orexin franchise that we have at Takeda.
是的,安迪,我可以插話一下功效。本週的睡眠會議上我們有一個非常大的團隊,我們對武田的 Orexin 特許經營權感到非常興奮。
For TAK-861, we still believe it's going to be the first-in-class and the best-in-class to treat narcolepsy. And as we do research with physicians and patients really around the world most importantly in the U.S. as well. There is such a high need for better treatment options to really help people live a more functional life with narcolepsy.
對於 TAK-861,我們仍然相信它將成為治療發作性睡病的同類首創和最佳藥物。當我們與世界各地的醫生和患者一起進行研究時,最重要的是在美國。迫切需要更好的治療選擇,以真正幫助嗜睡症患者過更正常的生活。
And so it's always going to be a trade-off with the dosing and the actual functionality that we can get. And so we are very confident that whatever profile we go for with dosing will be to really maximize functionality in these patients. And as Andy said, it's early days to say now exactly how we're going to plan to do that, but we're very confident in our target product profile for TAK-861.
因此,我們總是需要在劑量和實際功能之間進行權衡。因此,我們非常有信心,無論我們採用何種劑量方案,都將真正最大限度地提高這些患者的功能。正如 Andy 所說,現在確切地說我們將如何計劃做到這一點還為時過早,但我們對 TAK-861 的目標產品概況非常有信心。
Stephen Barker - Equity Analyst
Stephen Barker - Equity Analyst
Just 1 quick follow-up. Regarding the safety. So you were testing very large doses in this first -- in this Phase I versus what you are testing in Phase II. And the safety profile looks very good. Does that give you -- how do you -- does that improve your confidence about the safety of this asset?
只需 1 次快速跟進。關於安全。因此,您在第一階段測試了非常大的劑量,而不是在第二階段測試。而且安全性看起來非常好。這是否會讓您—您如何—提高您對該資產安全性的信心?
Andrew S. Plump - President of Research & Development and Representative Director
Andrew S. Plump - President of Research & Development and Representative Director
The more -- Stephen, the more experience we have, the more -- the stronger we feel about the safety profile of TAK-861. And I'll just reiterate something I said during the presentation, which is that we've now enrolled 180 patients approximately in between the 2 Phase IIb studies. We've had -- we've obviously been very cautious around all safety parameters, especially liver function tests, and we have an independent data safety monitoring board that's been tracking.
史蒂芬,我們擁有的經驗越多,我們對 TAK-861 安全性的感覺就越強烈。我只想重申我在演講中所說的話,即我們現在在兩項 IIb 期研究之間招募了大約 180 名患者。我們顯然對所有安全參數都非常謹慎,尤其是肝功能測試,我們有一個獨立的資料安全監測委員會一直在追蹤。
And we haven't seen any signals consistent with liver toxicity. And it's very consistent with the margins that we have and the doses that we're using. So we feel quite good about the overall safety and tolerability profile at this point.
我們還沒有看到任何與肝毒性一致的訊號。這與我們現有的利潤和我們正在使用的劑量非常一致。因此,我們目前對整體安全性和耐受性狀況感到非常滿意。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] Daiwa Securities, Hashiguchi-san, please ask your question.
[解讀]大和證券,橋口先生,請提問。
Kazuaki Hashiguchi - Research Analyst
Kazuaki Hashiguchi - Research Analyst
[Interpreted] Yes, this is Hashiguchi. TAK-291 Phase II data, psoriatic arthritis, I see a presentation, I, actually, read the abstract of this presentation.
[譯] 是的,我是橋口。 TAK-291 II 期數據,乾癬性關節炎,我看到一個演示文稿,實際上,我讀了這個簡報的摘要。
And (inaudible) data compared to that data, I believe that the efficacy is actually about the same. And AEs adverse events about the same in low dose. And in higher dose, TAK-279 has a higher incidence of AEs, it seems.
和(聽不清楚)數據相比,我相信功效其實是差不多的。不良事件和不良事件在低劑量時大致相同。在較高劑量下,TAK-279 的 AE 發生率似乎較高。
I understand it's a different population. And I want to understand how to interpret the data from this study. And for TAK-279, how do you assess the competitiveness of this compound? That's my question.
我知道這是不同的人群。我想了解如何解釋這項研究的數據。對於TAK-279,您如何評估該化合物的競爭力?這就是我的問題。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
So a question on the TAK-279 psoriatic arthritis Phase II abstract that was recently published. Andy, your thoughts on that?
關於最近發表的 TAK-279 乾癬關節炎 II 期摘要的問題。安迪,你對此有何看法?
Andrew S. Plump - President of Research & Development and Representative Director
Andrew S. Plump - President of Research & Development and Representative Director
Sure. Thanks, Chris. And thanks, Hashiguchi-san. So not to steal the thunder from the presentation that's coming up in just a few weeks. Let me just make a few high-level comments.
當然。謝謝,克里斯。謝謝,橋口先生。因此,不要搶了幾週後即將舉行的演示的風頭。讓我發表一些高水準的評論。
The first is that it's very important to look at the study differences between our study and previous studies in psoriatic arthritis and in particular, the timing of the endpoint. So we're looking at a 12-week time point and most other studies look at a 16-week endpoint.
首先,了解我們的研究與先前的乾癬性關節炎研究之間的差異非常重要,特別是終點的時間。因此,我們著眼於 12 週的時間點,而大多數其他研究著眼於 16 週的終點。
It's also important to look at the differences in the underlying patient population, and we'll discuss some of those differences at the presentation next month.
研究潛在患者群體的差異也很重要,我們將在下個月的演講中討論其中的一些差異。
And then the third point I'll make is that the psoriatic arthritis is often misunderstood in terms of its disease presentation. It's actually in a continuum with psoriasis. So most patients with psoriatic arthritis have skin lesions, plaque and most patients with psoriasis actually end up developing some joint problems. And so the 2 diseases are highly related.
我要說的第三點是,銀屑病關節炎在其疾病表現方面經常被誤解。它實際上與牛皮癬是連續的。因此,大多數乾癬性關節炎患者都會出現皮膚損傷、斑塊,大多數乾癬患者實際上最終會出現一些關節問題。所以這兩種疾病是高度相關的。
And so when we're looking at endpoints in psoriatic arthritis, we're looking at both joint endpoints and skin endpoints. What we've learned through multiple mechanisms in these that inhibit these cytokines, IL-12, IL-23 interferon is that the dose response characteristics on the joint endpoints tend to be fairly flat. That's something that we consistently see across therapies.
因此,當我們研究銀屑病關節炎的終點時,我們同時考慮關節終點和皮膚終點。我們透過抑制這些細胞激素、IL-12、IL-23 幹擾素的多種機制了解到,聯合終點的劑量反應特徵往往相當平坦。這是我們在各種療法中始終看到的情況。
We're expecting to see significant differentiation from our competitors is again going to be on the skin endpoints. So you'll see more of those data, and we'll provide some additional details around those data during the presentation.
我們期望在皮膚端點上再次看到與競爭對手的顯著差異。因此,您將看到更多這些數據,我們將在演示期間提供有關這些數據的一些其他詳細資訊。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
Okay. So next, we'd like to take a question from Cowen, Mike Nedelcovych.
好的。接下來,我們想回答 Cowen Mike Nedelcovych 的問題。
Michael Thomas Nedelcovych - Research Associate
Michael Thomas Nedelcovych - Research Associate
My question is on ENTYVIO. It's a bit surprising to hear that COVID is still measurably affecting IBD diagnosis and treatment rates. And I imagine, it's difficult to tease that impact out from other factors.
我的問題是關於 ENTYVIO 的。聽到新冠病毒仍在顯著影響 IBD 的診斷和治療率,這有點令人驚訝。我想,很難從其他因素中剔除這種影響。
So I'm curious, are you seeing that diagnosis and treatment in other therapeutic categories are showing a lingering effect of the pandemic? And if not, what do you think is different about IBD? And what is your best guess when we might see normalization?
所以我很好奇,您是否看到其他治療類別的診斷和治療顯示出大流行的揮之不去的影響?如果不是,您認為 IBD 有何不同?當我們可能看到正常化時,您的最佳猜測是什麼?
And then on the subcutaneous launch, I know it's very early, but I'm curious if you see any early indicators that the subcutaneous product will push ENTYVIO toward the higher end of management's peak sales guidance? Or do you think that headwinds, such as the competition you described and the lingering effects of COVID might cause you to lean more cautiously?
然後關於皮下注射產品的推出,我知道現在還很早,但我很好奇您是否看到任何早期跡象表明皮下注射產品將推動 ENTYVIO 邁向管理層峰值銷售指導的高端?或者您認為逆風,例如您所描述的競爭和新冠病毒的持續影響可能會讓您更加謹慎?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
Julie, would you like to answer that question or those questions?
朱莉,你想回答這個問題或那些問題嗎?
Julie Kim - President of the U.S. Business Unit & U.S. Country Head
Julie Kim - President of the U.S. Business Unit & U.S. Country Head
Yes, sure. Thanks, Mike for the questions. In terms of the comments around the suppression of diagnosis, what we we're looking at is in terms of claims data. There are a number of different claims databases that you can see in the U.S. to give you an indication.
是的,當然。謝謝麥克提出的問題。就有關抑制診斷的評論而言,我們關注的是索賠數據。您可以在美國查看許多不同的索賠資料庫來為您提供指示。
And when we look at, for example, Crohn's disease, in particular, across 2 different claims databases in the U.S., there's a roughly 1 shows 8% to 10% decline in diagnosis and in Crohn's disease in particular, and the other shows closer to 20% decline in diagnosis in the last 12 months that we have in terms of the claims data. So that's why we're saying that the diagnosis rates are still being impacted post-COVID.
例如,當我們查看美國兩個不同的索賠資料庫中的克羅恩病時,大約有一個顯示診斷率下降了8% 至10%,尤其是克羅恩病,而另一個則顯示接近8% 至10%。從索賠數據來看,過去 12 個月診斷率下降了 20%。這就是為什麼我們說診斷率在新冠疫情之後仍然受到影響。
Now you asked about other areas. So we did take a look at a number of other areas. And while I don't have the specific numbers off the top of my head, we did see similar suppression, although not at the high level of Crohn's disease, but we did see similar suppression and diagnosis in a few other areas as well. So not quite sure why. There are some theories out there in terms of the suppression of inflammation overall because of COVID, but it's something that we are keeping a close eye on and continuing to monitor.
現在你問了其他領域。所以我們確實研究了其他一些領域。雖然我沒有具體的數字,但我們確實看到了類似的抑制,儘管克羅恩病的水平不是很高,但我們確實在其他一些領域也看到了類似的抑制和診斷。所以不太清楚為什麼。有一些關於因新冠肺炎而總體上抑制發炎的理論,但我們正在密切關注並繼續監測這一點。
We're focusing on what we can focus on in terms of supporting the need for treatment based on the mechanism of action of ENTYVIO and our continued demonstration of safety in the IBD space. And so the subcutaneous pen is another opportunity for us to demonstrate the value of ENTYVIO in IBD, and we're very excited about that.
我們專注於根據 ENTYVIO 的作用機制以及我們在 IBD 領域不斷證明的安全性來支持治療需求方面我們可以關注的事情。因此,皮下注射筆是我們展示 ENTYVIO 在 IBD 中的價值的另一個機會,我們對此感到非常興奮。
I think I covered all of them, Chris, but if I missed something, please.
克里斯,我想我已經涵蓋了所有內容,但如果我遺漏了什麼,請指出。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
I think there's a question on peak sales. Maybe Christophe, if you'd like to jump in on the peak sales and how subcu impacts the potential.
我認為關於峰值銷售存在一個問題。也許是 Christophe,如果您想了解銷售高峰以及 subcu 如何影響潛力。
Christophe Weber - President, CEO & Representative Director
Christophe Weber - President, CEO & Representative Director
Thank you, Mike for the question. well, when we look at ENTYVIO positioning and it's the market share that ENTYVIO has, especially for bio-naïve patients. Combined with the launch of the ENTYVIO Pen, combined with the growth of ENTYVIO actually also outside of the U.S., we are very much confident about our peak estimate of between USD 7.5 million and USD 9 billion.
謝謝麥克提出的問題。好吧,當我們看看 ENTYVIO 的定位時,它是 ENTYVIO 所擁有的市場份額,特別是對於未接受過生物治療的患者。結合 ENTYVIO Pen 的推出,再加上 ENTYVIO 實際上也在美國以外地區的成長,我們對 750 萬美元至 90 億美元的峰值估計非常有信心。
Actually, if you do the math, compared to the current situation, our current revenue in 2023, it will record a peak of 7.5% to 9%. That's equivalent to a CAGR between 4 and 6 for the product.
其實你算一下,和現在的情況相比,我們現在的收入到2023年,會錄得7.5%到9%的峰值。這相當於該產品的複合年增長率在 4 到 6 之間。
So we feel it's completely achievable, considering the strength of the ENTYVIO profile, as well as the launch of the pen.
因此,考慮到 ENTYVIO 外形的強度以及筆的推出,我們認為這是完全可以實現的。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
Okay. Next question, we'd like to call upon Miki Sogi from Bernstein.
好的。下一個問題,我們想請伯恩斯坦的 Miki Sogi 來回答。
Miki Sogi - Research Analyst
Miki Sogi - Research Analyst
I also have a question regarding the ENTYVIO. So I understand that you are expecting the subcu to be a new growth driver for this product. But I also like to understand the source of business for the subcutaneous formulation. I imagine that the majority of the source of business is coming from existing ENTYVIO patients. And potentially, add more of the -- additional growth will come from new patients. Is that the right understanding?
我還有一個關於 ENTYVIO 的問題。所以我理解您期望 subcu 成為該產品新的成長動力。但我也想了解皮下製劑的業務來源。我認為大部分業務來源來自現有的 ENTYVIO 患者。並且有可能增加更多——額外的增長將來自新患者。這是正確的理解嗎?
And also when you say 30% to 40% of the IBD patients will be on SC. So is this something additional? Is this -- or just -- it's just replacing being in the current market?
而且當你說 30% 到 40% 的 IBD 患者會接受 SC 治療。那麼這是額外的東西嗎?這是——或者只是——它只是取代當前市場中的存在?
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
So a question about the source of business for ENTYVIO subcutaneous. Perhaps, I would like to ask Ramona to comment on experience that we've seen in markets where we've already launched the subcutaneous device in Europe is, of course, 1 example.
那麼關於ENTYVIO皮下注射的業務來源的問題。也許,我想請雷蒙娜評論一下我們在歐洲推出皮下設備的市場所看到的經驗,當然,這只是一個例子。
And then if Julie has anything to add after that, please jump in. Ramona?
如果朱莉之後還有什麼要補充的,請加入。雷蒙娜?
Ramona Sequeira - President of Global Portfolio Division
Ramona Sequeira - President of Global Portfolio Division
Yes, absolutely. This is Ramona here. So as we look at launching the subcu in the U.S. and take the learnings from what we've seen when we've launched the subcu in a number of markets in Europe now and are launching in other parts of the world. And including Japan, there's 2 things that happen. One is we are able to go to new customers. So if you think about the U.S., we've got -- as well as Europe and other markets, we've got customers that are heavy infusion prescribers. But we've got other customers that aren't as linked to infusion clinics and tend to prescribe much more subcu.
是的,一點沒錯。這是雷蒙娜。因此,當我們考慮在美國推出 subcu 時,我們會從目前在歐洲多個市場推出 subcu 以及在世界其他地區推出 subcu 時所看到的情況中汲取經驗教訓。包括日本在內,發生了兩件事。一是我們能夠接觸新客戶。因此,如果您考慮美國,以及歐洲和其他市場,我們的客戶都是大量輸液處方者。但我們還有其他客戶與輸液診所沒有那麼大的聯繫,並且傾向於開更多的 subcu。
Our focus has been more on the infusion providers at this stage -- to this stage in ENTYVIO's life cycle. As we bring the subcu out, it gives us new customers, new providers to go to, and that allows us to access new patients.
我們的重點更放在現階段的輸液提供者上——到 ENTYVIO 生命週期的這個階段。當我們推出 subcu 時,它為我們提供了新的客戶、新的醫療服務提供者,這使我們能夠接觸到新的患者。
So that's where we've seen a lift around the world as we brought the subcu out in accessing these new providers and new patients that are new to the franchise.
因此,當我們推出 subcu 來接觸這些新的提供者和新的特許經營患者時,我們在世界各地看到了提升。
On the other side, we also have some cannibalization of existing patients. So the -- now we become the only product really that has both subcu and IV options, a really excellent pen, along with all the other benefits of ENTYVIO. Gut selective, long-term safety and efficacy data, and really an ideal first choice when conventional therapies fail.
另一方面,我們也有一些現有患者的蠶食。因此,現在我們成為唯一真正同時具有 subcu 和 IV 選項的產品,這是一支非常出色的筆,並且具有 ENTYVIO 的所有其他優點。腸道選擇性、長期安全性和有效性數據,確實是傳統療法失敗時理想的首選。
And so we do see some patients now that would be on the IV switching to the subcu, that ends up being net neutral to us, but it just gives more options for patients now who want to stay in the ENTYVIO family, and stay on ENTYVIO have different options for taking it.
因此,我們現在確實看到一些患者將使用 IV 切換到 subcu,這最終對我們來說是網絡中立的,但這只是為現在想要留在 ENTYVIO 家族並留在 ENTYVIO 的患者提供了更多選擇有不同的選擇。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
Okay. Since we are getting close to the end of the call, the next question will be our final question.
好的。由於通話即將結束,下一個問題將是我們的最後一個問題。
So I'd like to call upon Ueda-san from Goldman Sachs.
所以我想請高盛的上田先生發言。
Akinori Ueda - Equity Analyst
Akinori Ueda - Equity Analyst
[Interpreted] This is Ueda, Goldman Sachs. I would like to ask 2 questions about the business development.
[口譯] 我是高盛的上田。我想問2個關於業務發展的問題。
First of all, on Page 19, you are showing this information about oncology. EXKIVITY, negative progress and ALUNBRIG, strong competition and growth and launch share products are struggling in this background.
首先,在第 19 頁,您將展示有關腫瘤學的資訊。 EXKIVITY、負面進展和ALUNBRIG、強勁的競爭和成長以及推出共享產品都在這種背景下苦苦掙扎。
Do you feel that you need to do something additional to counter this situation? That's my first question.
您是否覺得需要做一些額外的事情來應對這種情況?這是我的第一個問題。
And the second question is in relation to that, you talked about strengthening the pipeline. So currently, what kind of franchise or what kind of phase -- development phase are you considering for potential in-licensing? Please share with us your current thoughts.
第二個問題與此相關,您談到了加強管道。那麼目前,您正在考慮什麼樣的特許經營權或什麼樣的階段——開發階段來進行潛在的許可?請與我們分享您目前的想法。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
So a question around our business development plans. First of all, in oncology to supplement the portfolio, and then looking at the pipeline, which phases, which therapeutic areas. I'd like to ask Christophe to comment on this.
這是一個關於我們業務發展計劃的問題。首先,在腫瘤學上補充產品組合,然後再看看管道、哪個階段、哪個治療領域。我想請 Christophe 對此發表評論。
Christophe Weber - President, CEO & Representative Director
Christophe Weber - President, CEO & Representative Director
Thank you, Ueda-san for the question. So first, I will say that we are not looking -- we just reconfirm to everyone that we are not looking at large M&A for scale purpose. So we are very competitive in all the key countries where we operate. So we don't have a scale or a competitive issue in that regard. So it's all about portfolio pipeline, so targeted BD.
謝謝上田先生的提問。首先,我要說的是,我們不會考慮——我們只是向大家再次確認,我們不會為了規模目的而考慮大型併購。因此,我們在我們開展業務的所有主要國家都非常有競爭力。因此,我們在這方面不存在規模或競爭問題。因此,這一切都與投資組合管道有關,因此有針對性的 BD。
On oncology, if we can bring new assets like (inaudible), fruquintinib that we just in-licensed, that would be terrific. So we are looking at this type of deals to complement our portfolio.
在腫瘤學方面,如果我們能夠帶來新的資產,例如(聽不清楚)我們剛獲得許可的呋喹替尼,那就太好了。因此,我們正在尋找此類交易來補充我們的投資組合。
We have a very attractive pipeline, but it's more mid-stage. So many of these products in our pipeline will be launched towards the end of the decade. So if we can bring more assets to enrich our portfolio, we'll do.
我們有一個非常有吸引力的管道,但它還處於中期階段。我們管道中的許多產品將在本世紀末推出。因此,如果我們能夠引入更多資產來豐富我們的投資組合,我們就會這麼做。
And we follow, in fact, roughly the same approach across the therapy area. Obviously, we are a leader in the GI space. So if we can bring other assets we'll do. We shouldn't forget that we have a very strong position in rare disease, in LSDs disease, so we are looking at that. In plasma-derived therapy, there is not much to do. So it's really about making our portfolio and pipeline more and more competitive.
事實上,我們在整個治療領域中遵循大致相同的方法。顯然,我們是地理標誌領域的領導者。因此,如果我們能帶來其他資產,我們就會這麼做。我們不應該忘記,我們在罕見疾病、LSD 疾病方面擁有非常強大的地位,所以我們正在關注這一點。在血漿衍生療法中,沒有什麼可做的。因此,這實際上是為了讓我們的產品組合和產品線變得越來越有競爭力。
So I think we are quite agnostic on the phase, but we are very focused on the therapy of the disease area because we want to leverage where we are strong and where we know -- where we have a very strong corporate knowledge about the disease. So that's what is guiding us for our business development strategy.
所以我認為我們對這個階段相當不可知,但我們非常關注該疾病領域的治療,因為我們希望利用我們的優勢和我們知道的地方——我們對這種疾病擁有非常豐富的企業知識。這就是我們業務發展策略的指導方針。
Christopher David O'Reilly - Global Head of IR & Global Finance
Christopher David O'Reilly - Global Head of IR & Global Finance
[Interpreted] With that, I would like to conclude today's call.
[解讀]我想結束今天的電話會議。
Thank you very much for your presence despite your busy schedule today. We'd like to ask for your continued support going forward.
非常感謝您今天在百忙之中抽空出席。我們希望得到您的繼續支持。
[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說出的。]