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Operator
Operator
Good morning to those from the U.K. and U.S. Good afternoon to those in Central Europe, and good evening to those listening in Asia. Welcome, ladies and gentlemen, to AstraZeneca's Q1 2022 Results Conference Call and webcast for investors and analysts.
早上好,來自英國和美國的人們,下午好,來自中歐的人們,晚上好,來自亞洲的聽眾。女士們,先生們,歡迎參加阿斯利康 2022 年第一季度業績電話會議以及面向投資者和分析師的網絡直播。
Before I hand over to AstraZeneca, I'd like to read the safe harbor statement. The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions, by their very nature, forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.
在我交給阿斯利康之前,我想閱讀安全港聲明。公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。本次電話會議的參與者可能對阿斯利康的運營和財務業績做出前瞻性陳述。儘管我們相信我們的預期是基於合理的假設,但就其本質而言,前瞻性陳述涉及風險和不確定性,並可能受到可能導致實際結果與這些前瞻性陳述所表達或暗示的結果存在重大差異的因素的影響。
Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to update forward-looking statements. Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation and webcast.
在本次電話會議上所做的任何前瞻性陳述都反映了本次電話會議時可獲得的知識和信息。公司不承擔更新前瞻性陳述的義務。還請仔細閱讀本演示文稿和網絡廣播隨附的幻燈片中的前瞻性聲明免責聲明。
(Operator Instructions) And with that, I will now hand you over to the company.
(操作員說明)然後,我現在將您交給公司。
Chris Sheldon - Head of IR
Chris Sheldon - Head of IR
Thank you, Martin, and good afternoon, everybody. I'm Chris Sheldon, Head of Investor Relations, AstraZeneca. I'm pleased to welcome you to AstraZeneca's First Quarter 2022 Conference Call. All materials presented today are available on our web page. Slide 2 has the usual safe harbor statements.
謝謝你,馬丁,大家下午好。我是阿斯利康投資者關係主管 Chris Sheldon。我很高興歡迎您參加阿斯利康 2022 年第一季度電話會議。今天展示的所有材料都可以在我們的網頁上找到。幻燈片 2 有通常的安全港聲明。
We'll be making comments on our performance using constant exchange rates, or CER, core financial numbers and other non-GAAP measures. Our non-GAAP to GAAP reconciliation is contained within the results announcements. Numbers used are in millions of U.S. dollars and for the first quarter of 2022, unless stated otherwise.
我們將使用恆定匯率或 CER、核心財務數據和其他非 GAAP 指標對我們的業績發表評論。我們的非公認會計原則與公認會計原則的對賬包含在結果公告中。除非另有說明,否則使用的數字為 2022 年第一季度的數百萬美元。
Please advance to Slide 3. This slide shows our agenda for today's call. In a moment, I'll hand you over to our CEO, Pascal Soriot, to begin. (Operator Instructions) Please advance to Slide 4. And with that, Pascal, over to you.
請轉到幻燈片 3。這張幻燈片顯示了我們今天電話會議的議程。稍後,我會將您交給我們的首席執行官 Pascal Soriot 開始。 (操作員說明)請前進到幻燈片 4。然後,帕斯卡,交給你。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Chris. Hello, everybody, and welcome to today's call. We had a strong start to the year, reporting first quarter total revenue of about $11.4 billion, an increase of 60%. Total revenues when excluding Vaxzevria for the quarter grew at 50%. Core EPS was $1.89, an increase of 20% over the prior year's quarter, benefiting from phasing and operational expenses, which our CFO, Aradhana will cover in more detail in a moment.
謝謝你,克里斯。大家好,歡迎來到今天的電話會議。我們今年開局強勁,第一季度總收入約為 114 億美元,增長 60%。本季度不包括 Vaxzevria 的總收入增長了 50%。核心每股收益為 1.89 美元,比上一季度增長 20%,這得益於分階段和運營費用,我們的首席財務官 Aradhana 稍後將更詳細地介紹這些費用。
Importantly, we delivered broad-based performance across our diverse disease area. Oncology grew 25%. CVRM increased 18%, R&I increased 4% and rare disease increased 7% on a pro forma basis.
重要的是,我們在不同的疾病領域提供了廣泛的表現。腫瘤學增長了 25%。在備考基礎上,CVRM 增加了 18%,R&I 增加了 4%,罕見病增加了 7%。
Our new consolidated vaccine and immune therapies area, V&I, delivered total revenue of $1.8 billion. This is the first quarter we have reported sales from this new disease area, which includes our COVID-19 vaccine, Vaxzevria and our long-acting antibody, Evusheld as well as Synagis and FluMist and soon, hopefully, nirsevimab.
我們新的綜合疫苗和免疫療法領域 V&I 實現了 18 億美元的總收入。這是我們報告這一新疾病領域銷售額的第一季度,其中包括我們的 COVID-19 疫苗 Vaxzevria 和我們的長效抗體 Evusheld 以及 Synagis 和 FluMist ,希望很快還有 nirsevimab 。
Iskra Reic, Executive Vice President of V&I, who is responsible for leading all V&I disease area activities is joining us for Q&A.
負責領導所有 V&I 疾病領域活動的 V&I 執行副總裁 Iskra Reic 將加入我們的問答環節。
We again saw robust news flow in the quarter, including EU approval in lupus for Saphnelo, U.S. approval in gMG for Ultomiris and U.S. Priority Reviews for both on Enhertu in HER2-mutant lung cancer and the combination of Imfinzi and tremelimumab in advanced liver cancer.
我們在本季度再次看到強勁的消息流,包括歐盟批准 Saphnelo 治療狼瘡、美國批准 Ultomiris 治療 gMG 以及美國對 Enhertu 治療 HER2 突變肺癌以及 Imfinzi 和 Tremelimumab 聯合治療晚期肝癌的優先審查。
Last but not least, we are particularly excited with the news from just 2 days ago with the fifth FDA breakthrough designation for Enhertu. This time in HER2-low breast cancer and based upon the data from our DESTINY-Breast04, which we look forward to sharing at the ASCO very soon.
最後但並非最不重要的一點是,我們對 2 天前的消息感到特別興奮,因為 Enhertu 獲得了 FDA 的第五個突破性指定。這次是 HER2-low 乳腺癌,基於我們的 DESTINY-Breast04 的數據,我們期待很快在 ASCO 上分享這些數據。
We have today reconfirmed our 2022 guidance with total revenue growth expected to increase at the high teens' percentage and core EPS growth to increase at mid to high 20s percentage.
我們今天再次確認了我們的 2022 年指引,預計總收入增長將以青少年的高百分比增長,核心每股收益增長將以 20 多歲的中高百分比增長。
Please turn to Slide 6. Performance in the quarter was driven by growth across our diversified disease areas and geographies. Our business mix continues to evolve. And in a quarter, oncology comprised 32% of our total revenues. Biopharma, which includes CVRM, R&I and V&I, makes us approximately half of our revenues. Importantly, with the addition of Alexion, rare disease now makes up approximately 15% of revenues.
請轉到幻燈片 6。本季度的業績受到我們多元化疾病領域和地區的增長的推動。我們的業務組合不斷發展。在一個季度,腫瘤學占我們總收入的 32%。包括 CVRM、R&I 和 V&I 在內的生物製藥為我們帶來了大約一半的收入。重要的是,隨著 Alexion 的加入,罕見病現在約佔收入的 15%。
The U.S., Europe, Emerging Markets and the Established Rest of World total revenues all saw strong growth in the period. And as you can see, the majority of revenues came from the U.S. in the quarter, followed by Emerging Markets.
美國、歐洲、新興市場和世界其他地區的總收入在此期間都出現了強勁增長。如您所見,本季度的大部分收入來自美國,其次是新興市場。
Our diversification in both these areas and geography reinforces our durable growth profile even in the face of industry-wide pressures, including pricing and reimbursement dynamics in developed markets and ongoing effects of the COVID-19 pandemic.
即使面對全行業的壓力,包括發達市場的定價和報銷動態以及 COVID-19 大流行的持續影響,我們在這些領域和地理上的多元化也加強了我們的持久增長前景。
Please move to Slide 7. With '22 off to a strong start, we are confident in both the near and long-term outlook for AstraZeneca. Looking ahead, we still have a number of key pivotal readouts that will not only reinforce our industry-leading science but also provide new growth opportunities.
請移至幻燈片 7。22 年開局良好,我們對阿斯利康的近期和長期前景充滿信心。展望未來,我們仍然擁有許多關鍵的關鍵數據,這些數據不僅會加強我們行業領先的科學技術,還會提供新的增長機會。
Notably coming up, we anticipate the Farxiga DELIVER trial readout in HFpEF and Ultomiris in the CHAMPION trial for NMOSD in the first half of this year. Looking beyond 2025, we are well positioned to continue to deliver industry-leading growth due to our robust lifecycle management, our innovative late-stage pipeline, but also complemented with our strategic business development efforts and importantly, a very durable exclusivity profile across the portfolio of commercialized products.
值得注意的是,我們預計今年上半年 NMOSD 的 CHAMPION 試驗中 HFpEF 和 Ultomiris 中的 Farxiga DELIVER 試驗讀數。展望 2025 年以後,我們有能力繼續實現行業領先的增長,這得益於我們強大的生命週期管理、我們創新的後期管道,而且還與我們的戰略業務發展努力相輔相成,重要的是,在整個投資組合中非常持久的排他性形象的商品化產品。
We have multiple earlier stage opportunities to unlock significant potential post 2025 with the best-in-class top 2 antibody drug conjugate with Dato-DXd and our next-generation PARP1 selective programs in oncology as well as eplontersen, our novel TTR silencer in bioharma, and exciting new C5 and Factor D approaches in rare disease. With that, I'll now hand over to Aradhana Sarin, our CFO, who will walk you through our financial performance. Please advance to Slide 8.
我們有多個早期階段的機會來釋放 2025 年後的重大潛力,其中包括與 Dato-DXd 和我們的下一代 PARP1 腫瘤學選擇性項目以及我們在生物危害中的新型 TTR 消音器 eplontersen 的同類最佳的前 2 名抗體藥物偶聯物,和令人興奮的罕見病新的 C5 和因子 D 方法。有了這個,我現在將交給我們的首席財務官 Aradhana Sarin,他將向您介紹我們的財務業績。請前進到幻燈片 8。
Aradhana Sarin - CFO & Executive Director
Aradhana Sarin - CFO & Executive Director
Thank you, Pascal, and hello, everyone. As usual, I will start with our reported P&L. Please turn to Slide 9.
謝謝你,帕斯卡,大家好。像往常一樣,我將從我們報告的損益開始。請轉到幻燈片 9。
As Pascal has highlighted, total revenue grew by 60% in the quarter, benefiting from both a full quarter of Alexion sales and higher COVID-19 revenues versus first quarter of last year. Our COVID-19 medicines, Vaxzevria and Evusheld contributed $1.6 billion of revenue in first quarter. The majority of Vaxzevria revenue came from initial contracts. We anticipate to fulfill most of our remaining obligations on initial contracts by second quarter.
正如 Pascal 所強調的那樣,本季度總收入增長了 60%,這得益於 Alexion 整個季度的銷售額以及與去年第一季度相比更高的 COVID-19 收入。我們的 COVID-19 藥物 Vaxzevria 和 Evusheld 在第一季度貢獻了 16 億美元的收入。 Vaxzevria 的大部分收入來自初始合同。我們預計到第二季度將履行初始合同的大部分剩餘義務。
Our reported gross margin declined by 6.6 percentage points, driven by the fair value adjustment of Alexion inventory, an impact we anticipate continuing for the remainder of the year as previously indicated.
由於 Alexion 庫存的公允價值調整,我們報告的毛利率下降了 6.6 個百分點,我們預計這一影響將持續到今年剩餘時間,如前所述。
Our reported operating expenses increased by 52%, driven by the addition of Alexion expenses. Our post Alexion restructuring plans are progressing according to plan. Total restructuring charges in the quarter amounted to $75 million, but we anticipate a step-up later in the year. As a reminder, we anticipate incurring onetime costs of approximately $2.1 billion until 2025, of which approximately $1.4 billion are cash costs and $700 million are noncash costs and capital investments of approximately $200 million. These activities are anticipated to realize run rate pretax benefits before reinvestment of about $1.2 billion by the end of 2025. Reported EPS was $0.25 in the quarter.
由於 Alexion 費用的增加,我們報告的運營費用增加了 52%。我們的 Alexion 後重組計劃正在按計劃進行。本季度的總重組費用為 7500 萬美元,但我們預計今年晚些時候會有所增加。提醒一下,我們預計到 2025 年將產生約 21 億美元的一次性成本,其中約 14 億美元是現金成本,7 億美元是非現金成本和約 2 億美元的資本投資。到 2025 年底,這些活動預計將實現稅前收益,然後再投資約 12 億美元。本季度報告的每股收益為 0.25 美元。
Please turn to Slide 10. Turning to the core P&L. Our gross margin increased by 4 percentage points to 79.3%, benefiting from the addition of Alexion sales with a higher gross margin and continuing mix shift to oncology. Q1 of last year was also adversely impacted by some inventory write-offs and valuations.
請轉到幻燈片 10。轉到核心損益表。我們的毛利率增長 4 個百分點至 79.3%,這得益於增加了毛利率更高的 Alexion 銷售以及持續向腫瘤學轉變。去年第一季度也受到一些庫存沖銷和估值的不利影響。
Our core operating expenses increased by 29% in the quarter, driven by the inclusion of Alexion expenses. Our outlook for the full year is unchanged, driven by a full year of Alexion expenses and continued investment in R&D and new launches.
由於包含 Alexion 費用,我們的核心運營費用在本季度增長了 29%。由於 Alexion 全年的開支以及對研發和新產品的持續投資,我們對全年的展望保持不變。
While our core operating margin in first quarter was approximately 35%, we anticipate our expenses to increase for the remainder of the year and margins to be lower in subsequent quarters as implied by our full year guidance. Core EPS of $1.89 represented a growth of 20%.
雖然我們第一季度的核心營業利潤率約為 35%,但我們預計今年剩餘時間我們的費用將增加,而後續季度的利潤率將降低,正如我們的全年指導所暗示的那樣。核心每股收益為 1.89 美元,增長了 20%。
Please turn to Slide 11. Today, we are reiterating our full year guidance we issued in February. We anticipate total revenue to grow by high teens percentage and core EPS to grow by mid- to high 20s percentage. As previously communicated, we anticipate China revenues to decline by mid-single-digit percentage in 2022, driven by NRDL and VBP impact. However, we expect total emerging market revenue, including China, to grow by mid-single-digit percentage.
請轉到幻燈片 11。今天,我們重申我們在 2 月份發布的全年指導。我們預計總收入將以十幾歲的百分比增長,核心每股收益將以 20 多歲的中高百分比增長。如前所述,在 NRDL 和 VBP 影響的推動下,我們預計 2022 年中國收入將下降中個位數百分比。然而,我們預計包括中國在內的新興市場總收入將以中個位數百分比增長。
We have previously highlighted some headwinds and tailwinds that we expect during the year. Our beta blocker Seloken will be impacted by VBP implementation in China later this year. Diagnosis and treatment rates across disease area are still being impacted by COVID-19. Anticipated tailwinds include demand of our differentiated COVID-19 antibody, Evusheld, which offers protection to some of the most vulnerable populations.
我們之前已經強調了我們在這一年中預期的一些逆風和順風。我們的 beta 阻斷劑 Seloken 將受到今年晚些時候在中國實施的 VBP 的影響。整個疾病領域的診斷和治療率仍受到 COVID-19 的影響。預期的順風包括對我們差異化的 COVID-19抗體 Evusheld 的需求,它為一些最脆弱的人群提供保護。
Finally, 2022 will be the first full year of Alexion consolidation.
最後,2022 年將是 Alexion 整合的第一年。
Please turn to Slide 12. Our cash flow from operating activities increased by $1.3 billion in the quarter to $3.2 billion, driven by strong underlying business growth and Alexion contribution. The final dividend for 2021, including the $0.07 increase we announced in February was paid in the quarter and amounted to $3 billion on a larger share base given the shares issued as part of the Alexion transaction.
請轉到幻燈片 12。在強勁的基礎業務增長和 Alexion 貢獻的推動下,我們的經營活動現金流在本季度增加了 13 億美元,達到 32 億美元。 2021 年的末期股息,包括我們在 2 月份宣布的 0.07 美元的增長,已在本季度支付,鑑於作為 Alexion 交易的一部分發行的股票,在更大的股份基礎上支付了 30 億美元。
During the quarter, we also made the first of 3 payments of $920 million to the former shareholders of Acerta. The 2 remaining payments of similar amounts will be made in 2023 and 2024.
在本季度,我們還向 Acerta 的前股東支付了 9.2 億美元的 3 筆款項中的第一筆。其餘兩筆類似金額的付款將在 2023 年和 2024 年支付。
We anticipate additional potential milestone payments of up to $1.1 billion relating to collaborations and partnerships, including Daiichi Sankyo to be paid during the remainder of the year should the relevant criteria be achieved.
如果達到相關標準,我們預計與合作和夥伴關係有關的額外潛在里程碑付款高達 11 億美元,包括第一三共將在今年剩餘時間內支付。
In the quarter, we also announced a settlement agreement with Chugai relating to Ultomiris, which will result in a payment of $775 million in the second quarter of 2022.
在本季度,我們還宣布與 Chugai 就 Ultomiris 達成和解協議,這將導致在 2022 年第二季度支付 7.75 億美元。
We currently have a reported net debt-to-EBITDA ratio of 3.6x. If adjusting for the Alexion fair value inventory uplift, which does not impact our cash flow, the ratio is 2.4x. Our capital allocation priorities remain unchanged, and we continue to invest in our business in order to deliver sustainable growth.
我們目前報告的淨債務與 EBITDA 比率為 3.6 倍。如果調整不影響我們現金流的 Alexion 公允價值庫存提升,該比率為 2.4 倍。我們的資本配置重點保持不變,我們繼續投資於我們的業務,以實現可持續增長。
With that, I will now hand over to Dave. Please turn to Slide 13.
有了這個,我現在將交給戴夫。請轉到幻燈片 13。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Thank you, Aradhana. Slide 14, please. We're pleased to report that our oncology total revenue grew 25% year-over-year during the first quarter with product sales growth of 18% and a regulatory milestone for Lynparza's FDA approval of OlympiA. Across brands, we saw double-digit year-on-year growth in Tagrisso, Imfinzi and Lynparza and a doubling in revenues for both Calquence and Enhertu. Growth was balanced across regions with the U.S., Europe, Emerging Markets and Established Rest of World, each driving double-digit year-on-year growth.
謝謝你,阿拉達納。請幻燈片 14。我們很高興地報告,我們的腫瘤學總收入在第一季度同比增長 25%,產品銷售增長 18%,這是 Lynparza 獲得 FDA 批准 OlympiA 的監管里程碑。在各個品牌中,我們看到 Tagrisso、Imfinzi 和 Lynparza 的同比增長達到兩位數,Calquence 和 Enhertu 的收入翻了一番。美國、歐洲、新興市場和成熟的世界其他地區的增長在各地區保持平衡,每個地區都推動了兩位數的同比增長。
Turning now to greater detail on each of our key oncology medicines. Tagrisso global revenues grew by 16%. Demand growth in the U.S. and Europe continues from rising first-line duration of treatment and increasing adjuvant use, partially offset by second-line use and persistent pandemic impact on diagnosis and testing rates.
現在談談我們每種主要腫瘤藥物的更多細節。 Tagrisso 的全球收入增長了 16%。美國和歐洲的需求繼續增長,原因是一線治療持續時間增加和輔助使用增加,部分被二線使用和大流行對診斷和檢測率的持續影響所抵消。
In the U.S., we saw sales growth of 6% versus Q1 '21, reflecting solid underlying demand, sequential sales versus Q4 were down, owing to inventory movements and a negative gross to net impact typically seen at the beginning of the year as Medicare and commercial plans reset.
在美國,與 21 年第一季度相比,我們看到銷售額增長了 6%,這反映了堅實的潛在需求,由於庫存變動和年初醫療保險和商業計劃重置。
In EM, Tagrisso grew 33%, with continued growth in EM outside of China and a strong start to the year in China with increasing demand in the front line and a good competitive performance maintained as Tagrisso's standard of care position in second line.
在新興市場,泰瑞沙增長了 33%,中國以外的新興市場持續增長,中國今年開局強勁,一線需求不斷增加,保持良好的競爭表現,這是泰瑞沙在二線的護理標準。
Imfinzi grew global revenues 11%. The PACIFIC indication and unresectable Stage III non-small cell lung cancer benefited from further approvals and is now highly penetrated as the standard of care across the globe. CASPIAN in small cell lung cancer is seeing growth from the launches and new approvals around the globe as our commercial team leverages the 3-year overall survival data published last year.
Imfinzi 的全球收入增長了 11%。 PACIFIC 適應症和不可切除的 III 期非小細胞肺癌受益於進一步的批准,現在已作為全球護理標準得到高度滲透。隨著我們的商業團隊利用去年發布的 3 年總體生存數據,CASPIAN 在小細胞肺癌領域的上市和新批准在全球範圍內取得了增長。
Sequentially, Imfinzi has been particularly affected by the pandemic as lung cancer diagnosis and treatment rates have remained 5% to 15% below pre-COVID levels. Across the globe, our Imfinzi teams are preparing in earnest for the launches of HIMALAYA and TOPAZ-1 later in the year, which are important growth catalysts for the brand.
隨後,Imfinzi 尤其受到大流行的影響,因為肺癌的診斷和治療率仍然比 COVID 之前的水平低 5% 至 15%。在全球範圍內,我們的 Imfinzi 團隊正在認真準備今年晚些時候推出的 HIMALAYA 和 TOPAZ-1,這是該品牌的重要增長催化劑。
Lynparza continued to solidify its position as the leading medicine in the global PARP inhibitor class. Product sales grew 17%, and we were delighted both by the U.S. approval of Lynparza in adjuvant breast cancer and to present an improvement in overall survival in the OlympiA study. U.S. sales were up 7% quarter-over-quarter, driven by greater use in ovarian, breast and prostate cancers. Sequential sales were affected by a similar seasonal pattern in channel inventory and gross-to-net adjustments that we saw with Tagrisso. Growth in Europe is 16% and 32% in Established Rest of World was supported by continued growth in HRD testing and launches in new markets. EM growth of 43% benefited from expanded patient access in ovarian cancer in China and launches in other Emerging Markets.
Lynparza 繼續鞏固其作為全球 PARP 抑製劑類領先藥物的地位。產品銷售額增長了 17%,我們很高興 Lynparza 在美國獲得批准用於輔助乳腺癌治療,並在 OlympiA 研究中展示了總體生存率的改善。受卵巢癌、乳腺癌和前列腺癌的更多使用推動,美國銷售額環比增長 7%。順序銷售受到與 Tagrisso 類似的渠道庫存和總淨額調整的季節性模式的影響。歐洲的增長率為 16%,世界其他地區的增長率為 32%,這得益於 HRD 測試和在新市場推出的持續增長。新興市場增長了 43%,這得益於中國卵巢癌患者可及性的擴大以及在其他新興市場的推出。
Turning now to hematology. Calquence continues to show excellent momentum with worldwide revenues, up 100% versus the first quarter last year. In the U.S., Calquence has a 55% share of new BTKi class starts in CLL, establishing itself as the clear standard of care. We look forward to those new patient starts turning into TRxs in the coming years given the long duration of patient benefit and treatment in this setting. In Europe, expansion is now in full swing, resulting in 32% sequential growth from Q4 '21 with more approvals on the horizon.
現在轉向血液學。 Calquence 在全球收入方面繼續表現出良好的勢頭,與去年第一季度相比增長了 100%。在美國,Calquence 擁有 55% 的新 BTKi 課程在 CLL 開始,將自己確立為明確的護理標準。鑑於在這種情況下患者受益和治療的持續時間很長,我們期待這些新患者在未來幾年開始轉變為 TRxs。在歐洲,擴張正在如火如荼地進行,從 21 年第四季度開始實現 32% 的環比增長,更多的批准即將到來。
And finally, for Enhertu, total revenue was up 117% to $86 million, benefiting from strong momentum in breast and gastric cancer in the U.S. and good growth in the third-line breast cancer in France, the U.K. and Germany.
最後,Enhertu 的總收入增長了 117% 至 8600 萬美元,這得益於美國乳腺癌和胃癌的強勁勢頭以及法國、英國和德國三線乳腺癌的良好增長。
Together with our partner, Daiichi Sankyo, our commercial teams are busy preparing for multiple launches, including DESTINY-Breast03, DESTINY-Breast04 and DESTINY-Lung01. Across the globe, our teams are preparing for an exciting year ahead as we anticipate these launches for Enhertu together with OlympiA and PROpel for Lynparza and the GI opportunities for Imfinzi that I mentioned earlier.
我們的商業團隊與我們的合作夥伴 Daiichi Sankyo 一起忙於準備多個發布,包括 DESTINY-Breast03、DESTINY-Breast04 和 DESTINY-Lung01。在全球範圍內,我們的團隊正在為即將到來的激動人心的一年做準備,因為我們預計 Enhertu 的這些發布以及 Lynparza 的 OlympiA 和 PROpel 以及我之前提到的 Imfinzi 的 GI 機會。
I look forward to providing you updates on those in the quarters ahead. And now I turn it over to Susan.
我期待在未來幾個季度為您提供最新情況。現在我把它交給蘇珊。
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
Thank you, Dave. Please turn to Slide 15. Enhertu continued to deliver this quarter, becoming the first treatment to show efficacy in HER2-low breast cancer in a pivotal trial, a historic landmark in clinical development with the capacity to change how breast cancer is categorized.
謝謝你,戴夫。請轉到幻燈片 15。 Enhertu 本季度繼續交付,成為第一個在關鍵試驗中顯示對 HER2-low 乳腺癌有效的治療方法,這是臨床開發的歷史性里程碑,能夠改變乳腺癌的分類方式。
In DESTINY-Breast04, Enhertu achieved a statistically significant and clinically meaningful improvement in both progression free survival and overall survival in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status versus standard of care chemotherapy.
在 DESTINY-Breast04 中,無論激素受體狀態與護理標準化療如何,Enhertu 在 HER2-low 不可切除和/或轉移性乳腺癌患者的無進展生存期和總生存期方面都取得了具有統計學意義和臨床意義的改善。
With the most recent one received in HER2-low breast cancer, Enhertu is now being granted 5 U.S. FDA breakthrough therapy designations, and a testament to the strength of data Enhertu has generated across several cancer types. It's fantastic to see the transformational nature of the data recognized by the FDA and also by ASCO, while I'm delighted that the DESTINY-Breast04 trial has been accepted as a plenary presentation at this year's meeting.
隨著最近一項在 HER2-low 乳腺癌中的應用, Enhertu 現在被授予 5 個美國 FDA 突破性治療指定,這證明了 Enhertu 在幾種癌症類型中產生的數據的強度。很高興看到 FDA 和 ASCO 認可的數據的變革性質,同時我很高興 DESTINY-Breast04試驗已被接受為今年會議的全體報告。
We're motivated by the opportunity to target the lower range of HER2 expression to delay disease progression and extend survival in those with metastatic breast cancer, where chemotherapy is the sole option for HR-positive progressors and HR-negative patients.
我們有機會針對較低範圍的 HER2 表達來延緩疾病進展並延長轉移性乳腺癌患者的生存期,其中化療是 HR 陽性進展者和 HR 陰性患者的唯一選擇。
The outcome of DESTINY-Breast04 makes us confident and excited for the DESTINY-Breast06 trial, which will look at Enhertu compared with chemotherapy in HER2-low and HER2-ultra-low HR-positive metastatic breast cancer patients whose disease has progressed on endocrine therapy. Data for this trial is due next year.
DESTINY-Breast04 的結果使我們對 DESTINY-Breast06 試驗充滿信心和興奮,該試驗將比較 Enhertu 與化療在 HER2-low 和 HER2-ultra-low HR 陽性轉移性乳腺癌患者的內分泌治療進展.該試驗的數據將於明年公佈。
Enhertu also continues its expansion beyond breast, affirming its wide applicability across multiple tumor types, as it has the potential to become the first treatment to be approved for a small but underserved category of patients with HER2-mutant non-squamous non-small cell lung cancer. These patients are typically female, never smokers with a poor prognosis and higher rate of brain metastases when compared to those without HER2 mutations.
Enhertu 還繼續在乳腺以外擴張,肯定了其在多種腫瘤類型中的廣泛適用性,因為它有可能成為第一個被批准用於少數但服務不足的 HER2 突變非鱗狀非小細胞肺患者的治療方法癌症。與沒有 HER2 突變的患者相比,這些患者通常是女性,從不吸煙,預後較差,腦轉移率較高。
With DESTINY-Lung01, which also has U.S. breakthrough therapy designation status, we hope to bring a new treatment option to the 2% of non-small cell lung cancer cases with a HER2 mutation.
憑藉 DESTINY-Lung01,也具有美國突破性治療指定狀態,我們希望為 2% 的 HER2 突變非小細胞肺癌病例帶來新的治療選擇。
Please turn to Slide 16. We had some disappointing news in the quarter with results from the CALLA trial, where Imfinzi did not meet the primary endpoint in the treatment of locally advanced cervical cancer. However, we continue with Imfinzi's comprehensive development program as a monotherapy and in combinations with other interventions.
請轉到幻燈片 16。我們在本季度有一些令人失望的消息,即 CALLA 試驗的結果,其中 Imfinzi 沒有達到治療局部晚期宮頸癌的主要終點。然而,我們繼續將 Imfinzi 的綜合發展計劃作為單一療法並與其他干預措施相結合。
EMERALD-3 seeks to compare the efficacy of Imfinzi plus tremelimumab plus or minus lenvatinib and concurrent (inaudible) alone in locoregional hepatocellular carcinoma. With this trial, we hope to repeat the positive results obtained in the HIMALAYA trial with the innovative STRIDE regimen for a single administration of tremelimumab added to Imfinzi resulted in a 3-year overall survival benefit in advanced HCC.
EMERALD-3 旨在比較 Imfinzi 加曲美木單抗加或減樂伐替尼和單獨並發(聽不清)在局部區域肝細胞癌中的療效。通過這項試驗,我們希望重複在 HIMALAYA 試驗中獲得的積極結果,創新的 STRIDE 方案在 Imfinzi 中單次給藥曲美木單抗可在晚期 HCC 中獲得 3 年的總體生存獲益。
Earlier this week, we were notified of the U.S. FDA submission acceptance with Priority Review for HIMALAYA, and we expect a decision later this year.
本週早些時候,我們收到了美國 FDA 提交接受 HIMALAYA 優先審查的通知,我們預計今年晚些時候會做出決定。
Now turning to our small molecule precision medicines. The SAFFRON trial will address MET resistance, one of the most common mechanisms of Tagrisso resistance. SAFFRON will evaluate Tagrisso in combination with Orpathys, a MET inhibitor being developed in collaboration with HUTCHMED to treat EGFR, MET-amplified non-small cell lung cancer patients who have progressed on Tagrisso. Results from both Phase III trials are expected to beyond 2023.
現在轉向我們的小分子精準藥物。 SAFFRON 試驗將解決 MET 耐藥性問題,這是 Tagrisso 耐藥性最常見的機制之一。 SAFFRON 將評估 Tagrisso 與 Orpathys 的組合,Orpathys 是與 HUTCHMED 合作開發的一種 MET 抑製劑,用於治療在 Tagrisso 上取得進展的 EGFR 、 MET 擴增的非小細胞肺癌患者。兩項 III 期試驗的結果預計將在 2023 年之後。
Upcoming news flow to look forward to for the remainder of the year includes data readouts for Imfinzi from PACIFIC-2, PEARL and EMERALD-1 as well as the CAPItello291 trial results for our AKT inhibitor, capivasertib.
今年剩餘時間即將發布的消息包括來自 PACIFIC-2、PEARL 和 EMERALD-1 的 Imfinzi 數據讀數,以及我們的 AKT 抑製劑 capivasertib 的 CAPItello291試驗結果。
Please turn to Slide 17. It was fantastic to be back in [New Orleans] earlier this month with the American Association for Cancer Research Annual Meeting, where we showcase some of our pioneering early signs across a number of modalities. I'll take you now through some of the main highlights.
請轉到幻燈片 17。本月早些時候回到 [新奧爾良] 參加美國癌症研究協會年會真是太棒了,我們在會上展示了我們在多種模式下的一些開創性早期跡象。我現在將帶您了解一些主要亮點。
Findings from the PETRA trial showed robust and durable target engagement across all doses of AZD5305, our next-generation, highly selective PARP1 inhibitor. AZD5305 demonstrated antitumor activity across a variety of tumors, including prostate, breast and ovarian cancer with a very good safety profile increasing our confidence in potential combinations within Enhertu and Dato-DXd.
PETRA 試驗的結果顯示,我們的下一代高選擇性 PARP1 抑製劑 AZD5305 的所有劑量都具有強大且持久的靶標參與。 AZD5305在多種腫瘤中表現出抗腫瘤活性,包括前列腺癌、乳腺癌和卵巢癌,具有非常好的安全性,增加了我們對 Enhertu 和 Dato-DXd 潛在組合的信心。
Secondly, some Phase I data was presented from MEDI5752 from our bispecific portfolio. MEDI5752 targets both PD-1 and CTLA-4 and produced dose-dependent increases in peripheral T cell proliferation as well as encouraging deep and durable responses in immunotherapy-naive tumors.
其次,我們的雙特異性產品組合中的 MEDI5752 提供了一些 I 期數據。 MEDI5752 同時靶向 PD-1 和 CTLA-4,並在外周 T 細胞增殖中產生劑量依賴性增加,並在未接受免疫治療的腫瘤中促進深度和持久的反應。
We are adding to a highly successful ADC strategy across multiple tumor types with our own proprietary platform that's resulted in the creation of AZD8205, a B7-H4-targeted antibody-drug conjugate with a (inaudible) linker warhead. AZD8205 recently entered Phase I trial in advanced solid malignancies. Its progression brings another step closer to replacing chemotherapy as the backbone of treatment in oncology.
我們正在使用我們自己的專有平台為多種腫瘤類型添加非常成功的 ADC 策略,從而創建了 AZD8205,這是一種帶有(聽不清)連接彈頭的 B7-H4 靶向抗體藥物偶聯物。 AZD8205 最近進入晚期實體惡性腫瘤的 I 期試驗。它的進展使替代化療成為腫瘤治療的支柱又邁進了一步。
I'll now hand over to Ruud to cover BioPharmaceuticals. Please advance to Slide 18.
我現在將交給 Ruud 來報導 BioPharmaceuticals。請前進到幻燈片 18。
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Thank you, Susan. Now turning to Slide 19. Looking at our BioPharmaceuticals businesses, Cardiovascular, Renal and Metabolism total revenues were up 18% to $2.2 billion. R&I was up 4% to $1.6 billion, and V&I delivered total revenues of $1.8 billion.
謝謝你,蘇珊。現在轉到幻燈片 19。看看我們的生物製藥業務,心血管、腎臟和代謝的總收入增長了 18%,達到 22 億美元。 R&I 增長 4% 至 16 億美元,V&I 的總收入為 18 億美元。
Farxiga achieved its first $1 billion quarter, a significant commercial milestone with 67% growth driven by strong underlying demand in type 2 diabetes, heart failure and chronic kidney disease and benefiting from updated treatment guidelines from ESC, the American Heart Association and ACC. Looking ahead, we expect to see sustained growth over the remainder of the year, adjusting for the onetime effects and an acceleration in chronic kidney disease driven by new reimbursements.
Farxiga 實現了第一個 10 億美元的季度,這是一個重要的商業里程碑,在 2 型糖尿病、心力衰竭和慢性腎病的強勁潛在需求的推動下,並受益於 ESC、美國心臟協會和 ACC 更新的治療指南,實現了 67% 的增長。展望未來,我們預計今年剩餘時間將持續增長,調整一次性影響和新的報銷推動的慢性腎病加速。
In Respiratory & Immunology, COVID-19 continues to have a material impact across markets and the portfolio. However, there were early signs of recovery towards the end of the quarter. Despite these headwinds, Fasenra grew 22% in the quarter, expanding its total market leadership in eosinophilic asthma. Fasenra is the leading biologic in the IL-5 class in major markets.
在呼吸與免疫學領域,COVID-19 繼續對整個市場和投資組合產生重大影響。然而,在本季度末出現了復甦的早期跡象。儘管存在這些不利因素,Fasenra 在本季度仍增長了 22%,擴大了其在嗜酸性哮喘領域的總體市場領導地位。 Fasenra 是主要市場中 IL-5 類的領先生物製劑。
Moving on to Breztri, with total revenues of $87 million. Breztri continued to gain market share within the fixed dose triple markets, especially in the U.S., China and Japan. Our new launch medicines Saphnelo and Tezspire are progressing well. Saphnelo demonstrated strong performance in new patient starts in the intravenous market for systemic lupus erythematosus.
繼續前進到 Breztri,總收入為 8700 萬美元。 Breztri 繼續在固定劑量三聯市場中獲得市場份額,特別是在美國、中國和日本。我們的新上市藥物 Saphnelo 和 Tezspire 進展順利。 Saphnelo 在系統性紅斑狼瘡靜脈注射市場的新患者開始表現強勁。
Tezspire made good headway achieving 11% new-to-brand prescriptions with broad utilization across all asthma phenotypes.
Tezspire 取得了良好進展,實現了 11% 的新品牌處方,並在所有哮喘表型中得到廣泛應用。
And finally, within V&I, Vaxzevria total revenue reached $1.1 billion in the quarter. And as Aradhana already mentioned, the majority of these sales are coming from initial contracts. We expect to conclude most of our remaining initial contracts' obligations in the second quarter.
最後,在 V&I 中,Vaxzevria 本季度的總收入達到了 11 億美元。正如 Aradhana 已經提到的,這些銷售的大部分來自初始合同。我們預計將在第二季度完成大部分剩餘的初始合同義務。
Evusheld, our long-acting antibody reached $469 million. We have begun fulfillment of the U.S. government order for 1.7 million units. The remainder of that order will be fulfilled before the end of 2022.
我們的長效抗體 Evusheld 達到 4.69 億美元。我們已經開始履行美國政府的 170 萬台訂單。該訂單的其餘部分將在 2022 年底之前完成。
Please turn to Slide 20. In Emerging Markets, total revenue was $3.4 billion in the quarter. Emerging Markets growth rate, including the impact of Vaxzevria was 32%, and this was split between Ex-China Emerging Market sales, which doubled versus quarter 1 2021 and China, where sales declined by 6%.
請轉到幻燈片 20。在新興市場,本季度總收入為 34 億美元。新興市場的增長率(包括 Vaxzevria 的影響)為 32%,這包括中國以外新興市場的銷售額(與 2021 年第一季度相比翻了一番)和中國的銷售額下降了 6%。
Farxiga has continued its remarkable growth across the region, 54% in the first quarter with China demand benefiting from increased patient screening. Heart failure and chronic kidney disease launches have also accelerated across the Ex-China Emerging Markets, which will support sustained growth in future quarters.
Farxiga 繼續在該地區實現顯著增長,第一季度增長 54%,中國需求受益於患者篩查的增加。除中國新興市場外,心力衰竭和慢性腎病的上市速度也在加快,這將支持未來幾個季度的持續增長。
Pulmicort sales in China continued to be impacted by VBP inclusion, which was implemented in October 2021. We expect the implementation of the seventh VBP round in the second half of 2022.
普米克在中國的銷售繼續受到 2021 年 10 月實施的 VBP 納入的影響。我們預計第七輪 VBP 將在 2022 年下半年實施。
As Dave mentioned, both Tagrisso and Lynparza continued to benefit from increased patient access due to the inclusion on to China's NRDL for March 2021 and from launches across Ex-China Emerging Markets.
正如 Dave 所提到的,由於 2021 年 3 月納入中國的 NRDL 以及在中國以外的新興市場推出,Tagrisso 和 Lynparza 繼續受益於增加的患者訪問。
Total revenue for Vaxzevria in Emerging Markets amounted to $530 million in the quarter, driven by initial and commercial contracts in Latin America and Asia. This included $56 million of collaboration revenue.
在拉丁美洲和亞洲的初始和商業合同的推動下,本季度 Vaxzevria 在新興市場的總收入達到 5.3 億美元。其中包括 5600 萬美元的合作收入。
Evusheld sales of $89 million were from multiple governmental contracts. Rare Disease Emerging Market sales of $115 million were impacted by Soliris or the timing in certain tender markets.
Evusheld 8900 萬美元的銷售額來自多個政府合同。罕見病新興市場銷售額 1.15 億美元受到 Soliris 或某些招標市場時機的影響。
I will now hand over to Mene to cover the R&D advancements in the period. Please turn to Slide 21.
我現在將交給梅內來介紹這一時期的研發進展。請轉到幻燈片 21。
Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board
Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board
Thank you, Ruud. 2022 has started with further expansion of our BioPharmaceuticals medicines. Evusheld and Saphnelo were approved in Europe, and Ondexxya was approved in Japan, which became the first country to approve its use with all of the Factor Xa inhibitors available today.
謝謝你,路德。 2022 年開始於我們的生物製藥藥物的進一步擴展。 Evusheld 和 Saphnelo 在歐洲獲得批准,Ondexxya 在日本獲得批准,日本成為第一個批准將其與當今可用的所有 Xa 因子抑製劑一起使用的國家。
Our cardiovascular pipeline continues to demonstrate progress for potential new medicines with the ambition to change standards of care. AZD8233 underscored its promise as a best-in-class PCSK9 inhibitor for the results from the ETESIAN Phase IIb trial showing that AZD8233 unique mode of action produced a 73% reduction in LDL cholesterol in patients with hypercholesterolemia.
我們的心血管管道繼續展示潛在新藥的進展,旨在改變護理標準。 AZD8233 強調了其作為同類最佳 PCSK9 抑製劑的承諾,ETESIAN IIb 期試驗的結果表明,AZD8233 獨特的作用模式使高膽固醇血症患者的 LDL 膽固醇降低了 73%。
As Ionis have disclosed, later this year, we will also have an interim analysis from the Phase III NEURO-TTRansform trial for eplontersen in polyneuropathy. We look forward to the much-anticipated Phase III results from Farxiga, the DELIVER trial in heart failure with preserved ejection fraction.
正如 Ionis 所披露的,今年晚些時候,我們還將對 eplontersen 治療多發性神經病的 III 期 NEURO-TTRansform 試驗進行中期分析。我們期待來自 Farxiga 的備受期待的 III 期結果,該試驗是射血分數保留的心力衰竭的 DELIVER 試驗。
Please turn to Slide 22. Data published from the MELODY and MEDLEY trials demonstrated the efficacy of nirsevimab 150 days after dosing and data published from the PROVENT trial showed that Evusheld antibody concentrations remained elevated 6 months after administration. These results are testimony to the longevity of protection afforded by AstraZeneca's proprietary YTE technology, one of the contributory factors behind Evusheld's success in the prevention of COVID-19.
請轉到幻燈片 22。MELODY 和 MEDLEY 試驗公佈的數據證明了 nirsevimab 在給藥後 150 天的療效,而 PROVENT 試驗公佈的數據顯示,Evusheld 抗體濃度在給藥後 6 個月仍然升高。這些結果證明了阿斯利康專有的 YTE 技術所提供的保護壽命長,這是 Evusheld 在預防 COVID-19 方面取得成功的促成因素之一。
Another factor behind that success is the careful selection of 2 complementary antibodies that bind distinct sites on the virus. This has helped Evusheld retain potent neutralization activity against the BA.2 variant, while many other antibody therapies are no longer effective.
成功背後的另一個因素是仔細選擇了結合病毒不同位點的 2 種互補抗體。這有助於 Evusheld 保留對 BA.2 變體的有效中和活性,而許多其他抗體療法不再有效。
AstraZeneca has 20 years of expertise in identifying and enhancing antibodies for the prevention of respiratory diseases, and this continues to be an active area of research for us as we think about future variants.
AstraZeneca 在識別和增強用於預防呼吸道疾病的抗體方面擁有 20 年的專業知識,當我們考慮未來的變體時,這仍然是我們活躍的研究領域。
I will now hand over to Marc to cover rare diseases and please turn to Slide 23.
我現在將交給 Marc 來報導罕見疾病,請轉到幻燈片 23。
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Thank you, Mene. Please turn to Slide 24. Rare Disease contributed $1.7 billion in the first quarter total revenues, representing a year-on-year pro forma increase of 7%. Our leading C5 franchise delivered durable pro forma growth of 6% in the first quarter.
謝謝你,梅內。請轉到幻燈片 24。罕見病在第一季度的總收入中貢獻了 17 億美元,同比增長 7%。我們領先的 C5 特許經營權在第一季度實現了 6% 的持久備考增長。
Soliris' performance was driven by growth in neurology indications and offset by continued conversion in PNH and atypical HUS. Ultomiris' growth of 25% in the quarter was in line with our expectations.
Soliris 的表現受到神經學適應症增長的推動,並被 PNH 和非典型 HUS 的持續轉換所抵消。 Ultomiris 本季度 25% 的增長符合我們的預期。
Finally, Strensiq performance in the quarter was impacted by inventory in payer dynamics. However, we observed strong demand and initiation exiting the quarter.
最後,Strensiq 在本季度的表現受到付款人動態庫存的影響。然而,我們觀察到本季度的強勁需求和啟動。
Now move to Slide 25. Following the exciting approval we announced just yesterday for Ultomiris in myasthenia gravis, and as we continue to advance our lifecycle management strategy, it is important to understand 2 key dynamics. The first is the revenue impact following the conversion due to Ultomiris lower annual treatment cost.
現在轉到幻燈片 25。繼我們昨天宣布對重症肌無力 Ultomiris 的激動人心的批准之後,隨著我們繼續推進我們的生命週期管理戰略,了解 2 個關鍵動態非常重要。首先是由於 Ultomiris 較低的年度治療成本,轉換後的收入影響。
In atypical HUS and myasthenia gravis, we will observe a revenue impact upon conversion to Ultomiris, since the annual treatment cost for Ultomiris is approximately 18% lower in the first year due to the need for a single loading dose, but 33% lower in subsequent treatment years.
在非典型 HUS 和重症肌無力中,我們將觀察到轉換為 Ultomiris 後的收入影響,因為由於需要單次負荷劑量,Ultomiris 的年度治療成本在第一年降低了約 18%,但隨後降低了 33%治療年限。
In PNH, we are reaching conversion saturation in some key geographies after achieving best-in-class conversion over 70% less than 18 months from launch over a year ago. Secondly, unlike our legacy indications, we expect the majority of long-term growth for Ultomiris in MG to come from complement naive patients.
在 PNH,我們在一年多前推出不到 18 個月的時間內實現了超過 70% 的一流轉化率,在一些關鍵地區達到了轉化率飽和。其次,與我們的傳統適應症不同,我們預計 Ultomiris 在 MG 中的大部分長期增長將來自補體天真的患者。
While we expect fairly rapid conversion from Soliris in line with what we observed in PNH, the bigger opportunity is to reach a broader patient population estimated between 25,000 and 30,000 of the approximately 90,000 diagnosed MG patients in the United States.
雖然我們預計 Soliris 的轉化速度與我們在 PNH 中觀察到的一致,但更大的機會是覆蓋更廣泛的患者群體,估計在美國約 90,000 名診斷出的 MG 患者中約有 25,000 至 30,000 人。
Looking ahead, we anticipate an acceleration in Ultomiris growth rates in the second half of this year and over time, growth in complement naive patients will offset the revenue impact from conversion.
展望未來,我們預計今年下半年 Ultomiris 增長率將加速,隨著時間的推移,補充天真的患者的增長將抵消轉換帶來的收入影響。
Please turn to Slide 26. Within the complement space, we continue to advance our innovative lifecycle management and NME programs. Our lifecycle management portfolios consisting of Ultomiris, Ultomiris subcutaneous and 1720, our mini-body C5 inhibitor support the durable long-term C5 franchise growth, given the opportunity for both differentiated pricing and (inaudible) expansions.
請轉到幻燈片 26。在補充空間內,我們繼續推進我們的創新生命週期管理和 NME 計劃。我們的生命週期管理產品組合包括 Ultomiris、Ultomiris 皮下和 1720,我們的迷你體 C5 抑製劑支持持久的長期 C5 特許經營增長,提供差異化定價和(聽不清)擴展的機會。
Our NME programs developed in-house further enhance our terminal C5 complement portfolio as well as expanding into new complement targets.
我們內部開發的 NME 計劃進一步增強了我們的終端 C5 補體組合,並擴展到新的補體目標。
Looking ahead of key upcoming catalysts, we now expect regulatory submission for 1840 in Wilson disease in the first half of 2023 in order to supply a comprehensive submission data package, inclusive of 2 ongoing mechanistic trials, which will complete by the end of this year.
展望即將到來的關鍵催化劑,我們現在預計在 2023 年上半年向監管機構提交威爾遜病 1840,以提供全面的提交數據包,包括 2 項正在進行的機械試驗,該試驗將於今年年底完成。
We expect headline results in the CHAMPION NMO trial for Ultomiris in the first half of this year, which presents another opportunity to advance complement inhibition in neurology. And with that, please turn to Slide 27, and I will hand the call back to Pascal for his closing commentary.
我們預計今年上半年 Ultomiris 的 CHAMPION NMO 試驗將取得主要結果,這為推進神經病學補體抑制提供了另一個機會。有了這個,請轉到第 27 張幻燈片,我會將電話轉回給 Pascal 以聽取他的結束評論。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Marc. And please move to next Slide 28. I will not spend too much time on this slide. The point of this slide is really to show you that we are very busy, and we have a very rich pipeline. And there will be important upcoming news flow across the company in the year ahead.
謝謝,馬克。請移至下一張幻燈片 28。我不會在這張幻燈片上花太多時間。這張幻燈片的重點是向您展示我們非常忙碌,並且我們擁有非常豐富的管道。未來一年,整個公司將會有重要的即將到來的新聞流。
In oncology, we'll be presenting the data from Enhertu DESTINY-Breast04 in HER2-low breast cancer at the ASCO as Susan mentioned earlier. We will also -- we are also looking forward to multiple Imfinzi radars across in lung and liver cancers in the next 12 months.
在腫瘤學方面,我們將在 ASCO 展示來自 Enhertu DESTINY-Breast04 在 HER2-low 乳腺癌中的數據,正如 Susan 之前提到的那樣。我們還將——我們也期待在未來 12 個月內有多個 Imfinzi 雷達用於肺癌和肝癌。
In CVRM, we will have data from the DELIVER trial for Farxiga and HFpEF and in Rare Disease, data from Ultomiris and NMOSD. We also look forward to data from eplontersen in ATTR polyneuropathy through our partnership with Ionis.
在 CVRM 中,我們將獲得來自 Farxiga 和 HFpEF 的 DELIVER 試驗的數據,在罕見疾病中,我們將獲得來自 Ultomiris 和 NMOSD 的數據。我們還期待通過與 Ionis 的合作從 eplontersen 獲得 ATTR 多發性神經病的數據。
You can also see we have a rich series of news flows extending into 2023.
您還可以看到我們有一系列豐富的新聞流延伸到 2023 年。
With that, please turn to Slide 29. We're pleased to have started the year on a strong note and we maintain that we are all well positioned to deliver long-term, durable growth in the years to come. We've committed to double-digit growth on the CAGR basis through to 2025. Beyond 2025, we believe that we will continue to have industry-leading growth from our innovative medicines, our robust internal pipeline, supplemental with smart business development and an attractive exclusivity profile for many of our marketed medicines.
有了這個,請轉到幻燈片 29。我們很高興在今年開始時表現強勁,我們堅持認為我們都做好了在未來幾年實現長期、持久增長的準備。我們承諾到 2025 年在復合年增長率的基礎上實現兩位數增長。2025 年之後,我們相信,我們將繼續通過我們的創新藥物、強大的內部管道、智能業務發展和有吸引力的業務實現行業領先的增長。我們的許多已上市藥物的排他性概況。
As Aradhana mentioned, we are reconfirming our full year 2022 guidance, and we anticipate another year of double-digit revenue growth in the high teens, together with growth in core EPS of mid to high 20s, all at constant exchange rates.
正如 Aradhana 所提到的,我們正在重新確認我們的 2022 年全年指導,我們預計在保持匯率不變的情況下,收入將在 2022 年保持兩位數增長,核心每股收益將增長 20 多歲。
Thank you for all joining. We'll now take questions, and I hand you back to Chris.
謝謝大家的加入。我們現在回答問題,我把你交給克里斯。
Chris Sheldon - Head of IR
Chris Sheldon - Head of IR
Thank you, Pascal. Please move to Slide 30. We'll now go to the Q&A. (Operator Instructions). Thank you in advance. Perhaps now we can take the first question from the conference call, and I'll hand you back to Pascal.
謝謝你,帕斯卡。請移至幻燈片 30。我們現在進入問答環節。 (操作員說明)。先感謝您。也許現在我們可以從電話會議中提出第一個問題,我將把你交給帕斯卡。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Chris. So the first one is from James Gordon at JPM. James, over to you.
謝謝,克里斯。所以第一個來自 JPM 的 James Gordon。詹姆斯,交給你了。
James Daniel Gordon - Senior Analyst
James Daniel Gordon - Senior Analyst
Hello. James Gordon, JPMorgan. One pipeline and one geographic please. The first one was on the pipeline, and it was a question your confidence in 2 oncology mechanisms that have had some mixed competitor data. So I know you've got AKT data, so Phase III data in the second half of this year. Competitor data has maybe been a bit mixed there. So bullishness on that product and can we read from competitor data. And then also, you've got your oral SERD (inaudible) this year, and I believe the Phase III next year, but the (inaudible) doesn't look so good for that mechanism.
你好。摩根大通的詹姆斯·戈登。請一條管道和一條地理信息。第一個正在籌備中,這是一個問題,您對 2 種具有一些混合競爭對手數據的腫瘤學機制的信心。所以我知道你有 AKT 數據,所以今年下半年有 III 期數據。那裡的競爭對手數據可能有點混雜。所以看好該產品,我們可以從競爭對手的數據中讀取。此外,您今年已經獲得了口頭 SERD(聽不清),我相信明年是第三階段,但(聽不清)對於該機制來說看起來不太好。
So are there important differences? Or should we make some read through? So that's the pipeline question, please.
那麼有重要的區別嗎?還是我們應該通讀一遍?這就是管道問題,拜託。
And the other question was geographic on China. It was released to reiterate the guidance on China (inaudible). But can you talk a little bit about what are you seeing on the ground? Because some of the reports suggest that people are struggling to access supplies. Is it just that the guidance was quite conservative for China already and so you're able to get this in there? Or is there some risk to China if lockdowns going longer. So what are you seeing on the ground? And is there still some risk around China we should worry about?
另一個問題是關於中國的地理問題。發布它是為了重申對中國的指導(聽不清)。但是你能談談你在地面上看到的東西嗎?因為一些報告表明人們正在努力獲取物資。僅僅是因為中國的指導已經相當保守了,所以你能把它放在那裡嗎?或者,如果封鎖時間延長,中國是否會面臨一些風險。那麼你在地面上看到了什麼?中國周圍是否還有一些我們應該擔心的風險?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, James. So Chris, I have to tell you, you haven't been more successful than anybody else before you to discipline everybody to one question, but those are 2 great questions to answer with the sub question in the first one. So the first one, I'll hand over to Susan. Susan, can you go ahead?
謝謝你,詹姆斯。所以克里斯,我必須告訴你,在你將每個人都訓練到一個問題之前,你並沒有比其他任何人更成功,但這是兩個很好的問題,可以用第一個子問題來回答。所以第一個,我將交給蘇珊。蘇珊,你能繼續嗎?
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
So for the question on capivasertib, our AKT inhibitor, the randomized Phase III trial that's reading out this year is in ER-positive breast cancer on a background of [fulvestrant] in the second line. And we have confidence in this based on the randomized Phase II study, the FAKTION data that we saw.
因此,對於我們的 AKT 抑製劑 capivasertib 的問題,今年正在宣讀的隨機 III 期試驗是在二線 [fulvestrant] 背景下的 ER 陽性乳腺癌。基於隨機 II 期研究,我們看到的 FAKTION 數據,我們對此充滿信心。
Just in terms of comparison with competitors, I would remind you that we've got an intermittent dosing regimen 4 days on, 3 days off. And we chose that quite carefully based on an optimization of safety, which means that you've then got a lower discontinuation rate. I think that's important for maintenance of efficacy over time. And again, we didn't just see an improvement in PFS but also a trend to OS, which I think is important in this setting.
僅就與競爭對手的比較而言,我會提醒您,我們有一個間歇給藥方案 4 天,3 天休息。我們基於安全優化非常謹慎地選擇了它,這意味著您的停藥率會更低。我認為這對於長期維持療效很重要。同樣,我們不僅看到了 PFS 的改進,而且還看到了操作系統的趨勢,我認為這在這種情況下很重要。
So we're confident in the profile of what we've got with the AKT inhibitor on the dosing schedule that we're using at the moment, and we look forward to seeing the results later. It is, of course, the reason why we do Phase III trials to confirm what we saw in Phase II.
因此,我們對目前使用的 AKT 抑製劑給藥方案的概況充滿信心,我們期待稍後看到結果。當然,這也是我們進行 III 期試驗以確認我們在 II 期所見的原因。
On the note of camizestrant, again, just in terms of the principles, it's encouraging that we've seen activity in Phase I and some other data in Phase II now in ESR1 mutant patient population because in this setting of ESR1 mutated patients, we know the sensitivity to both aromatase inhibitors and drugs like fulvestrant is more limited and requires higher doses.
再次提到 camizestrant,就原則而言,令人鼓舞的是,我們現在在 ESR1 突變患者群體中看到了 I 期的活動和 II 期的一些其他數據,因為在這種 ESR1 突變患者的環境中,我們知道對芳香酶抑製劑和氟維司群等藥物的敏感性更為有限,需要更高的劑量。
We also saw good efficacy in our Phase I data set in this patient population. But remember that the rationale for using oral SERD is to improve the level of degradation that we can see with a drug like fulvestrant. And actually, if you look at the (inaudible) data that we had in first line, I still think there's room for improvement over that, and the profile of the oral SERDs are important.
我們還在該患者群體中的 I 期數據集中看到了良好的療效。但請記住,使用口服 SERD 的基本原理是提高我們使用氟維司群等藥物可以看到的降解水平。實際上,如果您查看我們在第一行中獲得的(聽不清)數據,我仍然認為還有改進的餘地,並且口頭 SERD 的概況很重要。
That being said, not all drugs in the same class are necessarily the same. And we have -- based on preclinical data, we know just based on the chemical structure that there are differences across the class.
話雖如此,並非同一類別的所有藥物都必須相同。我們有 - 基於臨床前數據,我們僅基於化學結構就知道該類別之間存在差異。
So we're confident in the dose that we have picked, 75 milligrams, that we want to go forward into the Phase III studies based on the data that we had from expanded dose cohorts in Phase I. I think it's very important to get both the efficacy level right for the dose as well as the safety. And we've seen good efficacy at that level. And we've also seen good safety with a low rate of discontinuation, a low to minimal GI side effects and asymptomatic effects on bradycardia and visual effects at that dose level.
因此,我們對我們選擇的劑量(75 毫克)充滿信心,我們希望根據 I 期擴大劑量隊列的數據繼續進行 III 期研究。我認為同時獲得兩者非常重要適合劑量的功效水平以及安全性。我們已經看到了在那個水平上的良好效果。我們還看到了良好的安全性,停藥率低,胃腸道副作用低至最小,在該劑量水平下對心動過緩和視覺效果的無症狀影響。
So I think actually, the data that we have seen gives us confidence in this class and the potential for them to impact a broader range of patients in the early line, but it also gives us confidence that the SERENA-6 study, which is selecting patients that have got an ESR mutation is also one that has a high confidence of probability of success.
所以我認為實際上,我們看到的數據讓我們對這個課程充滿信心,並且他們有可能影響更廣泛的早期患者,但它也讓我們相信 SERENA-6 研究正在選擇具有 ESR 突變的患者也是對成功概率具有高度信心的患者。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Susan. And in the SERD class, as Susan said, you may have differences in chemical structure between agents, but also those may be a factor. So really something to keep in mind.
謝謝你,蘇珊。正如蘇珊所說,在 SERD 類中,代理之間的化學結構可能存在差異,但這些也可能是一個因素。所以真的要記住一些事情。
Leon, do you want to cover the China outlook question and the impact potentially of the lockdown on supply?
Leon,你想談談中國前景問題以及封鎖對供應的潛在影響嗎?
Leon Wang - Executive VP of International & China President
Leon Wang - Executive VP of International & China President
Yes. I think the lockdown actually created some short-term disruption on the supply chain and import. 50% of AstraZeneca products are import and 50% are locally manufactured. So lockdown has impact on both supply chain and also the process of manufacturing because of the government policy.
是的。我認為封鎖實際上對供應鍊和進口造成了一些短期中斷。阿斯利康 50% 的產品是進口的,50% 是本地生產的。因此,由於政府的政策,封鎖對供應鍊和製造過程都有影響。
But I think AstraZeneca (inaudible) to make sure that the supply chain is smooth. And also lockdown has impact on inpatient and injectable oncology products (inaudible) like Imfinzi and also hospitalized products, which already (inaudible) and also nebulized (inaudible) also largely used in hospitals. So this has been impacted quite a lot in the hospital plus VBP.
但我認為阿斯利康(聽不清)確保供應鏈順暢。並且封鎖對住院和注射腫瘤產品(聽不清)如 Imfinzi 以及住院產品產生了影響,這些產品已經(聽不清)和霧化(聽不清)也大量用於醫院。所以這在醫院和 VBP 中受到了很大的影響。
So -- but we should also remember lockdown is not everywhere in China. It's only in several cities or provinces, and the lockdown will not be forever. So we assume it should be mainly in quarter 2, the impact is mainly in quarter 2.
所以——但我們也應該記住,中國並非無處不在。只是在幾個城市或省份,封鎖不會永遠存在。所以我們假設應該主要在第 2 季度,影響主要在第 2 季度。
So lockdown has limited impact on oral oncology products like Tagrisso and also has a limited impact on chronic disease products like Farxiga. So -- and VBP this year also has been delayed several months. So our major large product that has been performing quite strongly is Farxiga and also Tagrisso.
因此,封鎖對 Tagrisso 等口腔腫瘤產品的影響有限,對 Farxiga 等慢性病產品的影響也有限。所以——而且今年的VBP也被推遲了幾個月。所以我們表現相當強勁的主要大型產品是 Farxiga 和 Tagrisso。
And also, we remain our next 5-year growth, quite confident because of filing of Evusheld in China and approval of Enhertu (inaudible) next year. So in '24, we also have (inaudible) and DS-1062. So we already launched the Breztri, and it's doing quite well. So I think that this year, our shining part for China is Farxiga, Breztri and Tagrisso. So I think we are confident to stick to the current guidance.
而且,由於 Evusheld 在中國的備案和 Enhertu(聽不清)明年的批准,我們仍然保持下一個 5 年的增長,非常有信心。所以在 24 年,我們還有(聽不清)和 DS-1062。所以我們已經推出了 Breztri,它做得很好。所以我認為今年我們對中國的閃光部分是 Farxiga、Breztri 和 Tagrisso。所以我認為我們有信心堅持目前的指導方針。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Leon. Tim Anderson at Wolfe Research. Over to you, Tim.
謝謝你,萊昂。沃爾夫研究公司的蒂姆·安德森。交給你了,蒂姆。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
Thank you. If I could just stay on China for a minute. Last quarter, you were asked if China would grow in 2023. And I wasn't sure if Leon just answered that. Are you guys saying you will have positive growth in China in 2023 and you're confident about that? And then second, China question, just an update on the fraud investigation, please?
謝謝你。如果我能在中國停留一分鐘就好了。上個季度,有人問你中國是否會在 2023 年增長。我不確定 Leon 是否剛剛回答了這個問題。你們是說2023年在中國會有正增長,你對此有信心嗎?其次,中國問題,請提供有關欺詐調查的最新信息?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
So on the first question, actually, Tim, we don't give guidance beyond 2022, except for the fact that we said that over the next few years, we believe the Emerging Markets together, China and non-China Emerging Markets will grow at a high single digit rate. So beyond this, we haven't given any indication outside of '22.
所以關於第一個問題,蒂姆,實際上,我們不會給出 2022 年以後的指導,除了我們說在未來幾年內,我們相信新興市場一起,中國和非中國新興市場將增長個位數的高比率。因此,除此之外,我們沒有在 22 年之外給出任何指示。
The second question, Leon, do you want to cover this one on the investigation?
第二個問題,Leon,你想在調查中覆蓋這個問題嗎?
Leon Wang - Executive VP of International & China President
Leon Wang - Executive VP of International & China President
Yes. The [fraud] case in Shenzhen is actually limited to the individual's behavior. And I think the investigation will be soon concluded in quarter 2. So I think the company always have a very high standard on compliance and definitely for (inaudible) behavior within the company. So we are very confident about our system. And of course, we will learn from this case, try to make sure that this kind of case will not happen in the future.
是的。深圳的[詐騙]案其實僅限於個人的行為。而且我認為調查將很快在第二季度結束。所以我認為公司在合規方面總是有很高的標準,而且對於公司內部的(聽不清)行為肯定有很高的標準。所以我們對我們的系統很有信心。當然,我們會從這個案例中吸取教訓,盡量確保這種案例在未來不會發生。
So again, 2022 is a most difficult year because of VBP, lockdown and also the largest product, the Pulmicort that VBP impact plus (inaudible). So I think that's why we are quite confident that we will land properly in '22 and start gradually growing in the next 5 years.
再說一遍,2022 年是最困難的一年,因為 VBP、鎖定以及最大的產品,即 VBP 影響加上的 Pulmicort(聽不清)。所以我認為這就是為什麼我們非常有信心在 22 年正確著陸並在未來 5 年開始逐漸增長。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Leon. Andrew Baum at Citi. Andrew -- sorry, over to you.
謝謝,萊昂。花旗的安德魯鮑姆。安德魯——對不起,交給你了。
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
A couple of questions. So first one for David and Susan. What percentage of first-line patients with EGFR-mutated non-small cell experience or put on chemo before they determine the results of the biopsy. I'm just interested because obviously, if it's a high percentage, then adding Tagrisso, to that chemo background if the patient is found to have a driving mutation is obviously relatively easy compared to switching to a competitive regimen. And then secondly, in relation to your PARP1 data where you showed some quite intriguing data. Could you just confirm whether or not this is part of the Merck agreement in -- at the time of [olaparib] and so on?
幾個問題。所以第一個給大衛和蘇珊。在確定活檢結果之前,有多少百分比的 EGFR 突變非小細胞一線患者經歷或接受化療。我只是感興趣,因為顯然,如果百分比很高,那麼如果發現患者有驅動突變,那麼將 Tagrisso 添加到該化學背景中顯然與切換到競爭性方案相比相對容易。其次,關於你的 PARP1 數據,你展示了一些非常有趣的數據。您能否確認這是否是默克協議的一部分——在 [olaparib] 等時期?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Andrew. I think, Dave, you could take both questions. The first one, just -- I believe the first one is what is the percentage of patients who received chemo before being -- before we get the results of the EGFR test.
謝謝,安德魯。我認為,戴夫,你可以同時回答這兩個問題。第一個,只是 - 我相信第一個是在我們得到 EGFR 測試結果之前接受化療的患者百分比是多少。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
So Andrew, what we're seeing within the adjuvant setting, obviously, we're speaking about here. So I mean, I think with maybe...
所以安德魯,我們在輔助環境中看到的,顯然,我們在這裡談論。所以我的意思是,我認為也許...
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
I'm actually speaking about metastatic setting, not adjuvant. So we've heard that many younger patients who are nonsmokers, they're put on chemo and not PD-1 looks the assumption they probably have a driver mutation. So it was directed to the metastatic setting, first line metastatic.
我實際上是在談論轉移性設置,而不是佐劑。所以我們聽說許多不吸煙的年輕患者,他們接受化療而不是 PD-1,看起來他們可能有驅動突變的假設。因此,它針對轉移性環境,一線轉移性。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Got it. So I mean it's a minority of patients, Andrew, that are falling into this category. What we are seeing here is that there are -- maybe it's 10% to 15% of patients who fall into that category or who have disease that's particularly rapidly progressing for whom they do that, but it is not by any means, the majority of the patients that we see.
知道了。所以我的意思是,安德魯屬於這一類的少數患者。我們在這裡看到的是——也許有 10% 到 15% 的患者屬於該類別或患有疾病進展特別快的患者,他們這樣做是為了他們這樣做,但無論如何,大多數我們看到的病人。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Second one, PARP1 and Merck. Do you want to cover that one? This -- did you get the -- the question was the PARP1. And the what's the relationship with Merck and the broad Merck Collaboration Agreement.
第二個,PARP1和默克。你想覆蓋那個嗎?這個——你明白了嗎——問題是PARP1。以及與默克和廣泛的默克合作協議有何關係。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Got it. Yes. Thank you very, very much. So Andrew, on the PARP1 and the broad agreement, we've been really pleased with partnership that we've had with Merck, I think together that we've been able to create a tremendous amount of value on Lynparza. And in fact, I think that you can see that we've created the (inaudible) the leading PARP together with them.
知道了。是的。非常非常感謝你。所以 Andrew,關於 PARP1 和廣泛的協議,我們對與默克的合作夥伴關係非常滿意,我認為我們一起能夠在 Lynparza 上創造巨大的價值。事實上,我認為您可以看到我們與他們一起創建了(聽不清)領先的 PARP。
We're minded to continue to work with them within the PARP class and it's a matter of finding ways to ensure that it's at the right sets of terms.
我們打算繼續在 PARP 類中與他們合作,這是一個尋找方法來確保它符合正確的術語集的問題。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Dave. Mark Purcell at Morgan Stanley. Mark, go ahead.
謝謝,戴夫。摩根士丹利的馬克·珀塞爾。馬克,繼續。
Mark Douglas Purcell - Equity Analyst
Mark Douglas Purcell - Equity Analyst
Yes. Thank you, Pascal. A question on Farxiga, please. The standard performer again and surprising is the upside very much outside the U.S., which is very difficult for us to model. So whether it's you or Ruud, it would be great to sort of understand in terms of penetration rates for Farxiga and (inaudible) where we are when it comes to heart failure and the CKD indications in these key regions outside the U.S. You can sort of help us understand level of penetration and how much there is still to go. And then the subpart for many, the timing on the LCM proof-of-concept trials (inaudible), where are we there? When should we see data and level of conviction? That would be great.
是的。謝謝你,帕斯卡。請提一個關於 Farxiga 的問題。再次令人驚訝的標準表現是美國以外的優勢,這對我們來說很難建模。因此,無論是您還是 Ruud,了解 Farxiga 的滲透率以及(聽不清)我們在美國以外這些關鍵地區的心力衰竭和 CKD 適應症方面的情況都會很好。幫助我們了解滲透水平以及還有多少。然後是許多子部分,LCM 概念驗證試驗的時間安排(聽不清),我們在哪裡?我們什麼時候應該看到數據和信念水平?那很好啊。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Mark, and Ruud is smiling away. Not talking about oncology only, Farxiga is a fantastic product. So over to you, Ruud.
謝謝,馬克,路德微笑著離開了。 Farxiga 不只是談論腫瘤學,它是一個了不起的產品。所以交給你了,路德。
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Yes. Thank you so much, Mark, for the question. So regarding CKD, where we have launched CKD across the world. We are already having market shares between 70% and 90%. Of course, competition is coming in that setting as well. But equally, the upside in the CKD population is still very substantial because most of those patients are simply not proper diagnosed and so are not getting a treatment.
是的。非常感謝你,馬克,這個問題。因此,關於 CKD,我們在全球範圍內推出了 CKD。我們已經擁有 70% 到 90% 的市場份額。當然,競爭也隨之而來。但同樣,CKD 人群的優勢仍然很大,因為大多數患者根本沒有得到正確診斷,因此沒有得到治療。
For heart failure, it's roughly 50-50 in the majority of the markets, but equally, of course, our position versus the competition in the Emerging Markets and Europe is very strong. So in the U.S., it's roughly 50-50. But outside of the U.S., clearly, we have the majority of the share. Crucial is to get good results, hopefully, for the DELIVER results at the moment but primarily in the reduced ejection fraction for heart failure, but hopefully, later in the quarter, we will see the DELIVER results. But all in all, a very promising start of the year, and we expect to continue to see that in the remaining part of 2022.
對於心力衰竭,在大多數市場中約為 50-50,但同樣,當然,我們在新興市場和歐洲的競爭中的地位非常強大。所以在美國,大約是 50-50。但在美國以外,顯然我們佔據了大部分份額。至關重要的是,希望目前的 DELIVER 結果獲得良好的結果,但主要是心力衰竭的射血分數降低,但希望在本季度晚些時候,我們將看到 DELIVER 結果。但總而言之,這是一個非常有希望的開端,我們預計在 2022 年剩下的時間裡會繼續看到這一點。
Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board
Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board
(inaudible) combinations, I would say you'll start to see the conviction in those combinations towards the end of this year, first quarter of next year. That's when I think it will become visible.
(聽不清)組合,我想說你會在今年年底,明年第一季度開始看到這些組合的信念。那時我認為它會變得可見。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
And DELIVER?
和交付?
Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board
Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board
And DELIVER, this quarter.
並交付,本季度。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Okay. Thanks, Mene. Just one additional point, Mark, is that kidney disease is an enormous opportunity. As a reminder, 700 million people in the world suffer from kidney disease. It's -- I mean not relatively, it's very easy to diagnose, as you know. And we have large programs to early diagnose patients who until now we are not diagnosed because there's really -- there was really no treatment for them. In China, in particular, we've made enormous progress in diagnosing those people.
好的。謝謝,梅內。馬克,還有一點,腎臟疾病是一個巨大的機會。提醒一下,世界上有 7 億人患有腎病。這是 - 我的意思不是相對,它很容易診斷,如你所知。我們有大型項目來早期診斷那些直到現在我們還沒有被診斷出來的病人,因為真的 - 真的沒有治療方法。特別是在中國,我們在診斷這些人方面取得了巨大進展。
And the last point is you have to remember, I mean Farxiga is a relatively inexpensive product in many of those countries. So the price and the access are relatively -- I mean, they're not a big issue. So we should really see enormous growth based on the opportunity in kidney disease and the volume there.
最後一點是你必須記住,我的意思是 Farxiga 在許多國家是一種相對便宜的產品。所以價格和訪問是相對的——我的意思是,它們不是一個大問題。因此,基於腎臟疾病的機會和數量,我們真的應該看到巨大的增長。
So next question is Simon Baker at Redburn.
下一個問題是 Redburn 的 Simon Baker。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
It's on Tagrisso in China. You mentioned in the press release that the volume expansion has made up for the price reduction that you faced in March last year. I just wonder if you could give us an idea what that means in terms of penetration rates? And then just a sort of follow-up on Emerging Markets. Even (inaudible) for Vaxzevria, the Ex-China growth was incredibly strong. I just wonder if you could give us a little bit more color on the what and the where in driving that 75% growth?
它在中國的泰瑞沙上。您在新聞稿中提到,銷量擴張彌補了您在去年 3 月面臨的降價。我只是想知道你能否告訴我們這在滲透率方面意味著什麼?然後只是對新興市場的一種跟進。即使對 Vaxzevria 而言(聽不清),中國以外地區的增長也非常強勁。我只是想知道您是否可以給我們更多關於推動 75% 增長的內容和地點的信息?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Simon. So the China question, Leon, do you want to cover? And Dave, you cover the Rest of The World, is that okay?
謝謝,西蒙。所以中國的問題,Leon,你想討論一下嗎?戴夫,你報導世界其他地方,可以嗎?
Leon Wang - Executive VP of International & China President
Leon Wang - Executive VP of International & China President
Yes. I think the first question is about Tagrisso penetration. So with an idea of price cuts, and we get the first-line indication also approved in China with a quite significant price cuts. But we get into the first-line market, I think, with a 30%, 40% share in value already. And we are still getting new patients in the first line. And also, even though we are having ADAURA indication in China, and with this price level, even self-pay, many patients can really be affordable. So we are also starting to get into ADAURA patients -- adjuvant patients.
是的。我認為第一個問題是關於 Tagrisso 的滲透。所以有了降價的想法,我們得到的一線適應症也在中國得到批准,降價幅度相當大。但我認為,我們進入一線市場已經擁有 30%、40% 的價值份額。我們仍在第一線招募新患者。而且,即使我們在中國有 ADAURA 適應症,而且以這個價格水平,即使是自費,很多患者真的可以負擔得起。所以我們也開始進入 ADAURA 患者——輔助患者。
So -- and in second line, we are maintaining 2/3 of the patients, more than 2/3 of the patients is still using Tagrisso as the second-line treatment.
所以——在二線,我們維持 2/3 的患者,超過 2/3 的患者仍在使用泰瑞沙作為二線治療。
And regarding outside of China, Emerging Market growth mainly come from a very strong growth in oncology, new product launch and also quite strong -- the base business is actually respiratory Symbicort and even Pulmicort recovering and growing very strongly, driving by many countries. So both TA, oncology and the respiratory are doing very well. And in (inaudible) leading performance in the cardiovascular part, of course. Across the Emerging Markets, we still are getting order for our vaccine and getting new orders for our Evusheld. So I think Evusheld started in the Emerging Market, which is driving a good growth behind a very good historical Emerging Market outside China performance.
而在中國以外,新興市場的增長主要來自於非常強勁的腫瘤學增長、新產品的推出,而且也相當強勁——基礎業務實際上是呼吸系統信必可甚至普米科的複蘇和非常強勁的增長,在許多國家的推動下。所以 TA、腫瘤學和呼吸系統都做得很好。當然,在心血管部分的(聽不清)領先表現。在整個新興市場,我們仍在獲得疫苗訂單並獲得 Evusheld 的新訂單。所以我認為 Evusheld 是從新興市場開始的,這推動了中國以外非常好的歷史新興市場表現背後的良好增長。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Leon, and thank you for taking the second question. I had misunderstood it. So it was about Tagrisso, but it was, of course, broad-based Ex-China.
謝謝,Leon,謝謝你提出第二個問題。我誤解了它。所以它是關於泰瑞沙的,但它當然是基礎廣泛的前中國。
So the next question is Michael Leuchten at UBS.
所以下一個問題是瑞銀的邁克爾·勒赫滕。
Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research
Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research
Thank you, Pascal. It's Michael at UBS. One question for Dave and one for Marc. Then you keep flagging the impact that pandemic has on the oncology market. I just wondered if you could put into context for us why sequentially, though Lynparza and Imfinzi in the U.S. were down Q1 over Q4? Like why would the pandemic have more impact in Q1 than it had in Q4. And then question for Marc in Ultomiris. It's a product that continues to come below market expectations in the quarter. How quickly should we expect the new indication, MG, to make a difference to the product and start to offset the impact that pandemic still has here?
謝謝你,帕斯卡。是瑞銀的邁克爾。 Dave 一個問題,Marc 一個問題。然後,您不斷標記大流行對腫瘤學市場的影響。我只是想知道您是否可以為我們說明為什麼連續,儘管美國的 Lynparza 和 Imfinzi 在第一季度比第四季度下降?就像為什麼大流行在第一季度的影響比在第四季度的影響更大。然後在 Ultomiris 向 Marc 提問。該產品在本季度繼續低於市場預期。我們應該多快期待新的適應症 MG 對產品產生影響並開始抵消大流行仍然在這裡產生的影響?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Great. Thanks, Mike. Dave, please...?
偉大的。謝謝,邁克。戴夫,請……?
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
In terms of the U.S. and specifically on Lynparza and Imfinzi, there's actually 2 different dynamics that are at play here. So maybe just start first with Lynparza. Lynparza has good underlying demand. We're in the midst of launching the OlympiA indication. We're getting ready for PROpel moving forward. What we have affecting the Lynparza sequential sales is that oral drugs have a fairly significant gross-to-net impact in the first quarter in the U.S. And it simply is coming as a result of in private plans, co-pay resets, and so there's big use of co-pay cards among that population. And in the Medicare population, they come into the coverage gap immediately on the first fill. And so it balances itself out over the year, but you see a bigger impact that hits the sequential, and you see this pretty consistently.
就美國而言,特別是在 Lynparza 和 Imfinzi 上,實際上有兩種不同的動態在起作用。所以也許首先從 Lynparza 開始。 Lynparza 具有良好的潛在需求。我們正在推出 OlympiA 指示。我們正在為 PROpel 的前進做好準備。我們影響 Lynparza 連續銷售的是,口服藥物在美國第一季度產生了相當大的總淨額影響。這只是私人計劃、共付額重置的結果,所以有在該人群中大量使用共同支付卡。在醫療保險人群中,他們在第一次填補時立即進入覆蓋範圍。因此,它在一年中保持平衡,但您會看到更大的影響連續性,並且您會一直看到這一點。
With Imfinzi, it's different. We don't have those same gross-to-net impacts. Imfinzi is really where we're seeing quite a bit of impact on COVID treatment, diagnosis. Also keep in mind that these Stage III patients, which is the lion's share of where we get our business, have to go through CRT. There're backups within hospitals to be able to receive it. So Imfinzi is a difficult indication for PACIFIC in the context of COVID and what we're facing, I think that's pretty consistent with what you're hearing across the sector in lung cancer.
有了 Imfinzi,情況就不同了。我們沒有這些相同的總淨額影響。 Imfinzi 確實是我們看到對 COVID 治療和診斷產生相當大影響的地方。還要記住,這些 III 期患者,這是我們獲得業務的最大份額,必須通過 CRT。醫院內有備份可以接收它。因此,在 COVID 和我們面臨的情況下,Imfinzi 對 PACIFIC 來說是一個困難的跡象,我認為這與你在肺癌領域聽到的情況非常一致。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Dave. Marc?
謝謝,戴夫。馬克?
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Yes. So regarding the Ultomiris in myasthenia gravis, so we are delighted to have received the approval 2 days ago. To the question how quickly will Ultomiris go? I think we will have 2 phases. The first one will obviously be the conversion of Soliris to Ultomiris. We expect this conversion to be rapid. And we, in my prepared remarks, I indicated that it should be a pace which is similar to what we have seen in PNH in the key geographies. But this first phase of conversion will be superseded by a greater phase of expansion to a broader population of myasthenia gravis patient in comparison to Soliris. So this is where most of the growth will come. And this will not come in all geographies at the same time. This year, we will expect to get the approval in Japan and Europe. Then in Europe, we need to gain reimbursement in the various geographies and so on. So this will take a bit of time to expand Ultomiris in myasthenia gravis, but this is going to be a long and durable expansion trend for Ultomiris in MG.
是的。所以關於重症肌無力的Ultomiris,所以我們很高興兩天前得到了批准。對於這個問題,Ultomiris 會走多快?我認為我們將有兩個階段。第一個顯然是將 Soliris 轉換為 Ultomiris。我們預計這種轉換會很快。我們,在我準備好的評論中,我指出這應該是一個類似於我們在主要地區的 PNH 中看到的速度。但與 Soliris 相比,這一轉化的第一階段將被更廣泛的重症肌無力患者群體的更大階段所取代。所以這是大部分增長的地方。這不會同時出現在所有地區。今年,我們有望在日本和歐洲獲得批准。然後在歐洲,我們需要在各個地區獲得報銷等等。所以這將需要一些時間來擴展重症肌無力的 Ultomiris,但這將是 MG 中的 Ultomiris 的長期和持久的擴展趨勢。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Marc. Maybe also something that we sometimes wonder whether everybody captures the impact is the price effect. I mean when you switch from Soliris to Ultomiris, you have about a 17% price reduction in year 1 and about 30% or 33% beyond that in year 2 and beyond. So really keep this in mind as you look at the conversion phase from Soliris to Ultomiris.
謝謝,馬克。也許我們有時想知道是否每個人都能捕捉到影響的是價格效應。我的意思是,當您從 Soliris 切換到 Ultomiris 時,您在第 1 年降價約 17%,在第 2 年及以後降價約 30% 或 33%。因此,當您查看從 Soliris 到 Ultomiris 的轉換階段時,請牢記這一點。
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
And absolutely, you have you have, in a way, sort of a value leakage between -- in the conversion. But for -- as I just said, for Ultomiris, there will be a phase of conversion. The most important part for years to come will be the expansion in a broader population in myasthenia gravis.
絕對地,在某種程度上,在轉換中,你有一種價值洩漏。但是對於——正如我剛才所說,對於 Ultomiris,將會有一個轉變階段。未來幾年最重要的部分將是重症肌無力患者群體的擴大。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Marc. And the next one is Richard Parkes at BNP Paribas.
謝謝你,馬克。下一位是法國巴黎銀行的 Richard Parkes。
Richard, over to you. Are you on mute, Richard? I can't hear you.
理查德,交給你了。你靜音了嗎,理查德?我聽不見你。
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Yes, sorry about that, Pascal. Hopefully, you can hear me now. Just moving back to oncology. So I've got one for Susan on Dato-DXd. I just wondered if you could update us on where you are in the (inaudible) Dato-DXd plus chemo and PD-1, where you are in the dose escalation and when you might be able to make a decision on expanding on your current first-line Phase III trials for Dato-DXd. And then just a follow-up, I wondered if you -- if there are any futility or interim analysis on (inaudible) this year that we should be aware of?
是的,很抱歉,帕斯卡。希望你現在能聽到我的聲音。只是回到腫瘤學。所以我在 Dato-DXd 上為 Susan 準備了一份。我只是想知道您是否可以向我們更新您在(聽不清)Dato-DXd plus 化療和 PD-1 中的位置,您在劑量升級中的位置以及您何時可以決定擴大您目前的第一個Dato-DXd的線III期試驗。然後只是一個後續行動,我想知道您是否 - 我們應該注意對今年(聽不清)的任何無效或臨時分析?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Richard. Susan, just as a reminder, we never guide on interim analysis, but over to you.
謝謝,理查德。蘇珊,提醒一下,我們從不指導中期分析,而是交給你。
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
I was just about to say that. So for Dato-DXd, we are testing in combination with platinum-based chemotherapy as well as with PD-1 and PD-L1 antibodies across the program. We have published already some data for Enhertu in combination with durvalumab in the BEGONIA study last year. And what we didn't see is significant issues with tolerability for that combination. I would expect to see that translate across. We've obviously -- we'll share the data at a congress in due course. But I'll just say that I'm encouraged by the profile overall that we see for Dato-DXd, the activity that we're seeing across settings and the combinability gives us confidence that this is going to be an important medicine among multiple different indications.
我正要這麼說。因此,對於 Dato-DXd,我們正在與基於鉑的化學療法以及整個項目的 PD-1 和 PD-L1 抗體相結合進行測試。我們已經在去年的 BEGONIA 研究中公佈了 Enhertu 與 durvalumab 聯合的一些數據。我們沒有看到這種組合的耐受性存在重大問題。我希望看到這種翻譯。顯然,我們將在適當的時候在大會上分享數據。但我只想說,我對我們看到的 Dato-DXd 的整體概況感到鼓舞,我們在不同環境中看到的活動和可組合性讓我們相信這將成為多種不同的重要藥物適應症。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Susan. Emmanuel Papadakis at Deutsche Bank.
謝謝,蘇珊。德意志銀行的 Emmanuel Papadakis。
Emmanuel Douglas Papadakis - Research Analyst
Emmanuel Douglas Papadakis - Research Analyst
A couple of follow-ups, please. Perhaps one for Susan on the PARP1 AZD5305 (inaudible) particularly interested to hear your clinical spectrum and clinical potential for that asset from a commercial question earlier. And in particular, the potential is a combination regimen in light of the (inaudible) failure for Lynparza recently? And then a follow-up on the MG opportunity for Ultomiris. If you could just remind us what proportion of sales you estimate and indeed what number of patients you believe you're currently treating with Soliris in the MG setting? And indeed, can you provide any comments on the early impact of (inaudible) setting that would also be helpful.
請跟進幾個。也許是蘇珊在 PARP1 AZD5305(聽不清)上的一個,特別有興趣從之前的商業問題中聽到您對該資產的臨床譜和臨床潛力。特別是,鑑於最近 Lynparza 的(聽不清)失敗,潛在的組合方案是什麼?然後跟進 Ultomiris 的 MG 機會。如果您能提醒我們您估計的銷售額比例以及您認為目前在 MG 環境中使用 Soliris 治療的患者數量?事實上,您能否就(聽不清)設置的早期影響提供任何評論,這也將有所幫助。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks. Susan?
謝謝。蘇珊?
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
Okay. So for PARP1-selective, again, we're encouraged by the profile that we've seen. So by eliminating the inhibition of PARP2 reduce the level of bone marrow toxicity. And that means we've seen in the Phase I were ability to dose up beyond the 10-milligram dose level where you see equivalent target inhibition to what you see with the approved dose of [olaparib] up to 140 milligrams where you see (inaudible) for PARP1.
好的。因此,對於 PARP1 選擇性,我們再次對我們所看到的配置文件感到鼓舞。因此通過消除對PARP2的抑制降低了骨髓毒性水平。這意味著我們在第一階段看到的劑量超過 10 毫克的劑量水平,您看到的靶點抑制與您看到的批准劑量的 [olaparib] 高達 140 毫克(聽不見) 為 PARP1。
So we're seeing tolerability across that. And as we discussed at AACR, we see lower rates of bone marrow toxicity despite this is a heavily pretreated patient population, lower rates of anemia, lower rates of other adverse events. So that's a very encouraging profile for combinability in general. I also think there's an opportunity for it in potentially to broaden efficacy from what we have seen with the currently available PARP inhibitors because some patients that get (inaudible) mutations actually have a -- not complete reversion of the function of the protein. And in those patient populations, hitting the target harder might actually add efficacy. And so we were encouraged by seeing some activity in patients who had, had prior PARP and platinum treatment.
所以我們看到了耐受性。正如我們在 AACR 上討論的那樣,我們看到骨髓毒性發生率較低,儘管這是一個經過大量預處理的患者群體,貧血發生率較低,其他不良事件發生率較低。因此,總體而言,這是一個非常令人鼓舞的可組合性配置文件。我還認為它有可能擴大我們目前可用的 PARP 抑製劑的療效,因為一些獲得(聽不清)突變的患者實際上具有 - 不完全恢復蛋白質功能。在這些患者群體中,更努力地達到目標實際上可能會增加療效。因此,我們看到之前接受過 PARP 和鉑類治療的患者的一些活動讓我們感到鼓舞。
So I think that what we're also starting to understand is the broader array of patients that might benefit from PARP inhibition. So I think this opportunity for broader activity is monotherapy and for broad combinability and that's why we're excited about this molecule in general.
所以我認為我們也開始了解可能從 PARP 抑制中受益的更廣泛的患者群體。所以我認為這個更廣泛活動的機會是單一療法和廣泛的組合性,這就是為什麼我們對這種分子總體上感到興奮。
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
So regarding Soliris in myasthenia gravis, it is predominantly used in the refractory setting. So it's a high disease burden, a refractory setting in most geographies, including the United States, the -- in line with the clinical data that had been completed at that time for the approval in 2017.
因此,關於重症肌無力中的 Soliris,它主要用於難治性環境。因此,這是一個高疾病負擔,在包括美國在內的大多數地區都是一個難治的環境,這與當時已完成並於 2017 年獲得批准的臨床數據一致。
With the new data that we have just published and presented at medical congress is for Ultomiris, we see that roughly the population is estimated to be 3x larger. So this will increase the base of patients. And then in comparison to other mechanism, what we know of Ultomiris is that it provides a very durable inhibition of complement activation. We have shown primary data at 26 weeks. We have also published at 52 weeks, and we see this continued efficacy over this long period.
根據我們剛剛在醫學大會上發布並展示的針對 Ultomiris 的新數據,我們看到大約人口估計要大 3 倍。因此,這將增加患者的基礎。然後與其他機制相比,我們對 Ultomiris 的了解是它提供了對補體激活的非常持久的抑制。我們展示了 26 週時的主要數據。我們還在第 52 週發表了文章,並且我們看到了在很長一段時間內這種持續的療效。
Ultomiris, as you know, is administered once every 8 weeks. So in 45 minutes infusion. So overall, a relatively practical and convenient dose administration for patients. And we believe the durability of response as well as the predictability for patient will enable us to gain a wider population for Ultomiris in comparison to Soliris.
如您所知,Ultomiris 每 8 週給藥一次。所以在45分鐘內輸液。因此,總體而言,對於患者來說,這是一種相對實用和方便的劑量給藥方式。我們相信,與 Soliris 相比,反應的持久性以及對患者的可預測性將使我們能夠為 Ultomiris 獲得更廣泛的人群。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Marc. Adam Karlsson, ABG. Go ahead, Adam.
謝謝你,馬克。亞當卡爾森,ABG。來吧,亞當。
Adam Karlsson - Research Analyst
Adam Karlsson - Research Analyst
Just one, if I could. On the beneficial phasing of R&D and SG&A expenses in the quarter, should we take this as implying potentially less favorable phasing in Q2 as these effects reverse or the beneficial phasing effects related to the prior quarter with more costs having been taken in Q4 rather than Q1?
如果可以的話,就一個。關於本季度研發和 SG&A 費用的有利階段,我們是否應該認為這意味著第二季度可能不太有利的階段,因為這些影響會逆轉,或者與上一季度相關的有利階段效應,第四季度而不是第一季度承擔了更多成本?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks. Aradhana?
謝謝。阿拉達納?
Aradhana Sarin - CFO & Executive Director
Aradhana Sarin - CFO & Executive Director
So as we talk about the gross margins, the -- and actually the phasing throughout the year, we're still sticking to the guidance that we gave in the beginning of the year. The phasing is relating to expenses that we do expect to pick up in the later part of the year. So there's really no change in our guidance.
因此,當我們談論毛利率,實際上是全年的分階段時,我們仍然堅持我們在年初給出的指導。分階段與我們預計將在今年晚些時候增加的費用有關。所以我們的指導確實沒有變化。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Aradhana. Next question is from Sachin Jain at Bank of America. Sachin, over to you.
謝謝,阿拉達納。下一個問題來自美國銀行的 Sachin Jain。薩欽,交給你了。
Sachin Jain - MD & Research Analyst
Sachin Jain - MD & Research Analyst
Two, please. Firstly, on the SAFFRON study, Susan, wonder if you could talk about why you've gone in a refractory setting and not first line. Does that imply a specific view on the likely success of (inaudible) which is almost equivalent (inaudible) in first line? And then secondly, just a clarification on the PARP1. I know this is very early and we've only just had initial data at AACR. So apologies for this question, but do you have rough time lines in your mind season for potential Phase III starts and linked to an earlier question when Dave said we're looking to find the right sets of terms, does that need to be sorted before a Phase III can happen and assorting at the right terms of '22 event?
兩個,請。首先,關於 SAFFRON 研究,Susan,想知道您是否可以談談為什麼您進入了難治環境而不是第一線。這是否意味著對(聽不清)可能成功的具體看法,這在第一行幾乎等同(聽不清)?其次,只是對 PARP1 的澄清。我知道這還為時過早,我們剛剛在 AACR 獲得了初始數據。所以對這個問題表示歉意,但是當戴夫說我們正在尋找合適的術語集時,您是否對潛在的第三階段開始有粗略的時間線,並與較早的問題相關聯,是否需要在之前進行排序第三階段可以在 '22 事件的正確條件下發生和分類嗎?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
So Susan, 2 questions for you. And (inaudible) Lynparza -- for PARP1. That's a question you hear every day, I think. So go ahead.
蘇珊,給你 2 個問題。還有(聽不清)Lynparza —— 用於 PARP1。我想這是你每天都會聽到的問題。所以請繼續。
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
So thanks very much for the question, first of all. So for the SAFFRON study, the reason why we've gone in that setting is because we know MET amplification is seen in around 15% to 20% of patients following treatment with osimertinib. When you think about that in the context of a first-line trial, it's hard to design a study where that the effect is going to be concentrated in that patient group because you're effectively diluting that across the whole group. So that's why we've chosen it to be designed in this way. And I do think we have to wait and see what the results of the competitor trials are. But in contrast to when osimertinib was developed and T790M was the predominant resistance mechanism that was seen from first-generation EGFR inhibitors. What we're seeing is a more heterogeneous mechanism of resistance to drugs like osimertinib that hit T790M as well.
所以非常感謝這個問題,首先。因此,對於 SAFFRON 研究,我們之所以選擇這種環境,是因為我們知道在接受奧希替尼治療後,大約 15% 到 20% 的患者會出現 MET 擴增。當您在一線試驗的背景下考慮這一點時,很難設計一項研究,其中效果將集中在該患者組中,因為您有效地稀釋了整個組的效果。所以這就是我們選擇以這種方式設計它的原因。我確實認為我們必須拭目以待,看看競爭對手的試驗結果如何。但與開發奧希替尼時相比,T790M 是第一代 EGFR 抑製劑的主要耐藥機制。我們所看到的是對像奧希替尼這樣的藥物也有影響 T790M 的一種更加異質的耐藥機制。
And in addition, remember that one of the advantages that we have when we did the FLAURA study is that osimertinib had the blood-brain barrier penetrants compared with gefitinib or erlotinib. So there were different reasons why we saw advantage in that setting. And I do think that represents more of a challenge in the first-line setting in terms of trial design.
此外,請記住,我們進行 FLAURA 研究時的優勢之一是,與吉非替尼或厄洛替尼相比,奧希替尼具有血腦屏障滲透劑。因此,我們在這種情況下看到優勢有不同的原因。而且我確實認為,就試驗設計而言,這在一線環境中更具挑戰。
Moving to PARP1-selective, again, very keen to accelerate our development as soon as we're confident in a dose and the setting. And of course, that's something that we'll continue to do. And we'll be happy to let you know as soon as we've made that decision.
再次轉向 PARP1 選擇性,一旦我們對劑量和環境充滿信心,我們就非常熱衷於加速我們的發展。當然,這是我們將繼續做的事情。我們很樂意在做出決定後立即通知您。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
I think just, Sachin, on your second part of that second question, the development efforts can progress along as at whatever pace we're able to move them at and operate all of that on our own and independently.
我認為,薩欽,關於第二個問題的第二部分,開發工作可以按照我們能夠以任何速度移動它們並獨立運行所有這些的速度進行。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Yes, absolutely. Thank you, Dave. Matt Weston at Credit Suisse. Matt, over to you.
是的,一點沒錯。謝謝你,戴夫。瑞士信貸的馬特韋斯頓。馬特,交給你了。
Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research
Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research
Thanks, Pascal. I'm going to go for one question, and it's for Aradhana. Aradhana, we recently saw the SEC give guidance around partnership R&D charges and that they should be included in core EPS calculations. I think I'm right in saying that if implemented in Europe, that would have a very meaningful impact on Astra's core earnings given the accounting for the Enhertu and TROP2 relationships with Daiichi. Firstly, can you confirm if I'm right that, that is the case, it would have a meaningful impact? Secondly, do you see any pressure from IFRS to follow the SEC in changing the way core earnings are presented? Or could we even imagine Astra independently following SEC advice in line with the message from the CFO of Roche last week?
謝謝,帕斯卡。我要回答一個問題,這是針對阿拉達納的。 Aradhana,我們最近看到美國證券交易委員會就合作研發費用提供指導,並且應將其包含在核心每股收益計算中。我認為我的說法是正確的,如果在歐洲實施,考慮到 Enhertu 和 TROP2 與 Daiichi 的關係,這將對 Astra 的核心收益產生非常有意義的影響。首先,您能否確認我是否正確,如果是這樣,它會產生有意義的影響嗎?其次,您是否認為國際財務報告準則有任何壓力要求跟隨美國證券交易委員會改變核心收益的列報方式?或者我們甚至可以想像阿斯特拉根據上週羅氏首席財務官的信息獨立地遵循美國證券交易委員會的建議?
Aradhana Sarin - CFO & Executive Director
Aradhana Sarin - CFO & Executive Director
So we are, as you know, a foreign private issuer. So we filed both in the U.K. and the U.S. Our principal accounting framework is obviously the IFRS and not U.S. GAAP. So we don't expect -- anticipate any change to that. Obviously, if this is -- this is not unique to us. Actually, all the entire pharma space accounts for milestone payments the same way. So if there are changes, I think it would impact all of us in the same manner.
因此,如您所知,我們是一家外國私人發行人。因此,我們在英國和美國都提交了申請。我們的主要會計框架顯然是 IFRS 而不是美國公認會計原則。所以我們不期望 - 預計會有任何變化。顯然,如果這是 - 這不是我們獨有的。實際上,整個製藥領域都以相同的方式計算里程碑付款。因此,如果有變化,我認為它會以同樣的方式影響我們所有人。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Aradhana. Let me just add, Matt, that I mean, everybody likes to apply a [P] to an EPS, but good finance practice with the value of the company on a DCF basis. And if you do this, basically, what you raised as a point really doesn't have an impact, right? Because if you look at the - if you value the company based on cash flow, then wherever that cash outlay is captured basically falls into your DCF calculation. So hopefully, everybody will continue doing DCF modeling.
謝謝,阿拉達納。讓我補充一下,馬特,我的意思是,每個人都喜歡將 [P] 應用於 EPS,但在 DCF 基礎上具有公司價值的良好財務實踐。如果你這樣做,基本上,你提出的觀點真的沒有影響,對吧?因為如果您查看 - 如果您根據現金流量對公司進行估值,那麼無論在何處捕獲現金支出,基本上都屬於您的 DCF 計算。所以希望大家繼續做 DCF 建模。
The next question is from Seamus Fernandez at Guggenheim. Seamus?
下一個問題來自古根海姆的 Seamus Fernandez。西莫?
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
I'll just go with one. I'm hoping to learn a little bit more about when we might get some additional data from 1062. It seems like (inaudible), it seems like we could get results possibly as early as late 2022 , although I think you're still guiding for early 2023. Just wanted to get a sense of when we might get more information on 1062 in that setting. And then just as a follow-up to that very quickly, (inaudible), we know that you guys have been developing data in combination with pembro and with durva, I wanted to just get a sense of when we might see those data presented in a medical setting.
我只帶一個去。我希望能更多地了解我們何時可以從 1062 獲得一些額外的數據。看起來(聽不清),似乎我們最早可能在 2022 年底得到結果,儘管我認為你仍在指導到 2023 年初。只是想了解我們何時可以在該環境中獲得有關 1062 的更多信息。然後,作為一個非常快速的後續行動,(聽不清),我們知道你們一直在結合 pembro 和 durva 開發數據,我想了解一下我們什麼時候可以看到這些數據醫療環境。
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
Thank you for the question. So I should have said earlier, and I'll take the opportunity now to say that some more BEGONIA data, which is a platform study in triple-negative breast cancer is going to get presented at ESMO Breast next week, which will include the combination of (inaudible) and [durvalumab] in that setting. And again, I've already referred to the fact that we're comfortable with the combinability profile. So we look forward to sharing those data with you there.
感謝你的提問。所以我應該早點說,我現在要藉此機會說一些更多的 BEGONIA 數據,這是一個三陰性乳腺癌的平台研究,將於下週在 ESMO Breast 上展示,其中將包括組合(聽不清)和 [durvalumab] 在那種情況下。再一次,我已經提到了我們對可組合性配置文件感到滿意的事實。因此,我們期待在那裡與您分享這些數據。
In the lung cancer setting, the Phase III study that's already ongoing is obviously event-driven. So we have to wait and whether the events come in on site at the end of the year or the other.
在肺癌環境中,已經在進行的 III 期研究顯然是事件驅動的。因此,我們必須等待活動是否會在年底或其他時間進入現場。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Susan. Viktor Sundberg at Nordea. Viktor, over to you.
謝謝,蘇珊。維克多·桑德伯格在北歐。維克托,交給你了。
Viktor Sundberg - Senior Analyst
Viktor Sundberg - Senior Analyst
Pascal. So on camizestrant, I just wondered if you have enriched the trial SERENA-2 for [ESR1] carriers. And if not, what is your level of confidence on a positive readout here given that many patients might have already had (inaudible) blocking treatment in the early settings and perhaps the tumors are being driven by other factors in (inaudible) in the later settings. And I just have a quick follow-up on M&A. Do the current biotech (inaudible) you look more closely on smaller M&A deals, particularly in the U.S.? I, of course, appreciate that interesting signs should be a fire importance, but just interesting to understand your outlook for M&A here.
帕斯卡。所以在 camizestrant 上,我只是想知道您是否豐富了 [ESR1] 運營商的試用版 SERENA-2。如果沒有,鑑於許多患者可能已經在早期環境中接受過(聽不清)阻斷治療,並且在後期環境中(聽不清)中的其他因素可能會驅動腫瘤,您對此處陽性讀數的信心水平如何.我只是對併購進行了快速跟進。您是否更密切地關注小型併購交易,尤其是在美國的當前生物技術(聽不清)?當然,我很欣賞有趣的跡象應該是火的重要性,但在這裡了解您對併購的前景很有趣。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you. Susan, do you want to take the cami question?
謝謝你。蘇珊,你想回答卡米的問題嗎?
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
Yes, sure. So the expectation that -- in the second line patient population, such as SERENA-2 (inaudible) positive breast cancer, you'd expect to see an ESR mutation rate in the range of 30% to 40% in that patient population. So it won't be the majority of patients but a substantial minority of patients that are there. I think there are patients that still have endocrine sensitivity that don't have ESR mutations that are also present in that second line plus population. And again, as I said earlier, in the first line, endocrine, there is room for improvement in the endocrine-sensitive patient population over the currently available therapies beyond ESR mutation.
是的,當然。所以期望 - 在二線患者群體中,例如 SERENA-2(聽不清)陽性乳腺癌,您會期望在該患者群體中看到 30% 到 40% 的 ESR 突變率。因此,那裡不會是大多數患者,而是極少數患者。我認為有些患者仍然具有內分泌敏感性,但沒有 ESR 突變,這些突變也存在於二線加人群中。同樣,正如我之前所說,在第一線內分泌方面,內分泌敏感患者群體比目前可用的 ESR 突變以外的治療方法還有改進的空間。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Susan. On the second question, Viktor, I mean, just as a reminder of our capital question policy. Number one is to continue investing in our business, in our company. And as you can see from the presentation and discussion, we have a very rich pipeline. So lots to do across the entire company. So that's really our priority. The other one, of course, is to strengthen our credit rating.
謝謝你,蘇珊。關於第二個問題,維克多,我的意思是提醒我們資本問題的政策。第一是繼續投資我們的業務,投資我們的公司。從演示和討論中可以看出,我們有一個非常豐富的管道。整個公司有很多事情要做。所以這確實是我們的首要任務。另一個當然是加強我們的信用評級。
Having said all of this, of course, if good business development opportunities present themselves, we will consider them, and we are constantly looking. And it is true that the current environment that is rich in innovation but becoming a little bit more difficult from a funding viewpoint, that environment presents opportunities, but there's really no big change to what we've been doing, really. And again, our focus is really progressing our pipeline and launching our new products, and we're very busy with that.
說了這麼多,當然,如果出現良好的業務發展機會,我們會考慮,並且不斷尋找。確實,當前的環境充滿創新,但從資金的角度來看變得有點困難,這種環境提供了機會,但我們一直在做的事情並沒有太大的變化,真的。再一次,我們的重點是真正推進我們的管道和推出我們的新產品,我們非常忙於這件事。
And Aradhana, anything you wanted to add?
還有 Aradhana,你想補充什麼嗎?
Aradhana Sarin - CFO & Executive Director
Aradhana Sarin - CFO & Executive Director
No. Thank you.
不,謝謝。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Luisa Hector at Berenberg. Luisa, over to you.
貝倫貝格的路易莎·赫克托。路易莎,交給你了。
Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team
Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team
Thank you, Pascal. I wanted to ask on -- just a quick one on Vaxzevria in China. Roughly -- well, can you share what you're assuming for the year? And is there any upside for China sales of the vaccine based on your original assumptions at the start of the year? And then a second question on the diagnosis rates in oncology. When do you see those returning to a more normal level? And what role can you play in trying to expedite that.
謝謝你,帕斯卡。我想問一下——只是關於中國的 Vaxzevria 的一個簡短的問題。大致 - 好吧,你能分享一下你對這一年的假設嗎?根據您在年初的最初假設,疫苗在中國的銷售是否有任何上升空間?然後是關於腫瘤學診斷率的第二個問題。你什麼時候看到那些恢復到更正常的水平?你可以在試圖加快這一進程中扮演什麼角色。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Luisa. So the first question maybe, Leon, you could take. But I would expand it, if you don't mind, to Evusheld because here saying this is really the most important product in terms of protecting people who cannot be protected with vaccines. So a lot of people in China are vaccinated already. And the second, Dave, you could take? Leon, over to you.
謝謝,路易莎。所以第一個問題,Leon,你可以回答。但是,如果您不介意,我會將其擴展到 Evusheld,因為在這裡說這確實是保護無法用疫苗保護的人的最重要的產品。所以中國很多人已經接種了疫苗。第二個,戴夫,你能接受嗎?萊昂,交給你了。
Leon Wang - Executive VP of International & China President
Leon Wang - Executive VP of International & China President
Yes. In China, our vaccine actually was licensed to (inaudible) as a sub-license holder. So we are working closely with (inaudible) in China to really get the clinical trial approval to go ahead with further short-term strategy in China. So -- but it will not reflect in our revenue because it's -- we have a sublicense for the -- it will be a collaboration revenue.
是的。在中國,我們的疫苗實際上被許可(聽不清)作為分許可持有人。因此,我們正在與中國(聽不清)密切合作,以真正獲得臨床試驗批准,以在中國繼續實施進一步的短期戰略。所以 - 但它不會反映在我們的收入中,因為它是 - 我們有一個分許可 - 這將是一項合作收入。
So -- and most importantly is we are now filing our Evusheld in China. And Evusheld, I think, can protect the vulnerable part of the population. So with the pandemic ongoing in China, we believe our Evusheld has a position, has a place in China to help the pandemic, fighting the pandemic. So I think we will look forward to our approval in China by the end of the year. And we hope we can (inaudible) a government tender and also self-pay private market.
所以 - 最重要的是我們現在正在中國提交我們的 Evusheld。我認為,Evusheld 可以保護人口中的弱勢群體。因此,隨著大流行在中國持續蔓延,我們相信我們的 Evusheld 在中國有一個位置,有一個位置來幫助大流行,抗擊大流行。所以我想我們會期待我們在今年年底前在中國獲得批准。我們希望我們能夠(聽不清)政府招標和自費私人市場。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Leon.
謝謝你,萊昂。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Luisa, in terms of our expectations around recovery in diagnosis and testing rates, I would say that the greatest source of optimism that I've got is, right now, if we look in the U.S., that monthly COVID new cases has declined quite significantly relative to the very high rates that they were at end of fourth quarter, beginning of first quarter from Omicron.
路易莎,就我們對診斷和檢測率恢復的預期而言,我想說的是,我現在最大的樂觀來源是,如果我們看看美國,每月的 COVID 新病例已經顯著下降相對於他們在第四季度末的非常高的利率,第一季度初來自 Omicron。
I do think that in terms of what comes in front of us on new waves is impossible to understand, but I do think that we've seen a pretty good correlation between new COVID cases and the effect that it has on the diagnosis rate. So we follow that as bellwether pretty closely.
我確實認為,就新浪潮中我們面前的情況而言,我們無法理解,但我確實認為我們已經看到新的 COVID 病例與其對診斷率的影響之間存在很好的相關性。因此,我們非常密切地遵循它作為領頭羊。
In terms of what we can do to address it, we've been working diligently with advocacy groups across the globe on efforts to raise awareness around the importance of making patients -- taking the effort to get themselves to the doctor and to make sure that they follow up on routine checkups. I do think that, that's had a good amount of impact, but it doesn't take away from some of the very, very significant challenges that are faced here across the globe, but we continue to stay as vigilant as we can.
就我們能做些什麼來解決這個問題而言,我們一直在與全球的倡導團體密切合作,努力提高人們對讓病人的重要性的認識——努力讓自己去看醫生並確保他們跟進例行檢查。我確實認為,這產生了很大的影響,但這並不能消除全球面臨的一些非常、非常重大的挑戰,但我們會繼續盡可能保持警惕。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Dave. Peter Welford, Jefferies. Peter, over to you.
謝謝,戴夫。彼得韋爾福德,傑富瑞。彼得,交給你了。
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
First one, just on Alexion, I wonder if you could talk a little bit about the potential synergies if you've managed to get out of the product side. I appreciate it's still early days, but I guess, particularly thinking [for Ruud] with regard to now AndexXa is into your universe. And also you flagged particularly rare diseases in Emerging Markets. I wonder if (inaudible) a comment there on whether or not any progress has been made sort of incrementally to what Alexion did already in the Emerging Market area with those portfolios? And then just a clarification, if I can, just on the vaccine. You said for Vaxzevria, you expect to fulfill most of the existing initial contracts by 2Q. Does that mean there is still some potential for profit contracts that you've got already that go beyond 2Q? Or was that meant to mean that we shouldn't be assuming with the contracts you have at the moment any Vaxzevria revenues or any significant Vaxzevria revenues in the second half of the year?
第一個,就在 Alexion 上,我想知道如果你已經設法擺脫了產品方面,你是否可以談談潛在的協同效應。我很感激現在還處於早期階段,但我想,尤其是考慮 [為 Ruud] 關於現在 AndexXa 已進入您的宇宙。您還標記了新興市場中特別罕見的疾病。我想知道(聽不清)關於 Alexion 是否已經在新興市場領域對這些投資組合所做的工作有所進展的評論?然後只是澄清一下,如果可以的話,只是關於疫苗。您對 Vaxzevria 說,您希望在第二季度完成大部分現有的初始合同。這是否意味著您已經獲得了超出第二季度的利潤合同的潛力?或者這是否意味著我們不應該假設你目前擁有的合同有任何 Vaxzevria 收入或下半年任何可觀的 Vaxzevria 收入?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Peter. So a series of questions here. So Ruud you could take the AndexXa one? And Marc, the Rare Disease Emerging Market and maybe Iskra will take the vaccine, Vaxzevria question.
謝謝,彼得。所以這裡有一系列問題。所以 Ruud 你可以拿 AndexXa 一個嗎?馬克,罕見病新興市場和也許 Iskra 將接受疫苗,Vaxzevria 的問題。
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Yes. So let me take the first one regarding AndexXa. So since the beginning of the year, the BioPharma business unit is now responsible for the commercialization of AndexXa across the world. We have made some changes to our pricing, especially in the United States to get more formulary listings. It's a little bit too early in order to claim victory. But clearly, we see a positive impact already in the first few weeks. There's a clear need for this product. As we all know, brain bleedings are a devastating moment for patients. So the sooner you can stop the bleeding, the better it is for patients treated with Factor Xa inhibitors.
是的。因此,讓我談談關於 AndexXa 的第一個問題。因此,自今年年初以來,生物製藥業務部門現在負責 AndexXa 在全球的商業化。我們對定價進行了一些更改,特別是在美國,以獲得更多的處方列表。要宣布勝利還為時過早。但很明顯,我們已經在最初幾週看到了積極的影響。對這個產品有明確的需求。眾所周知,腦出血對患者來說是毀滅性的時刻。因此,您越早止血,對接受因子 Xa 抑製劑治療的患者就越好。
So we are hopeful that these products will be substantial in the cardiovascular unit of AstraZeneca, and we have teams around the world now beefing up in order to make it a success.
因此,我們希望這些產品將在阿斯利康的心血管部門中發揮重要作用,我們在世界各地的團隊正在加強以使其成功。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
If I may add, maybe the AndexXa but also Emerging Market, Rare Disease question, Marc will answer is really a great illustration of the synergies we can generate. I mean, as Ruud explained AndexXa, we are relaunching, and we think our scale in cardiovascular disease will help us. But we're also working on reducing the cost of goods, which has been an impediment. And the AZ and Alexion teams are working very hard together to reduce the cost of goods. Marc has been leading this effort together with Pam Cheng, our Head of Operations. We're making good progress. So a clear example of a very nice synergy between the 2 companies, Marc?
如果我可以補充一下,也許是 AndexXa 以及新興市場、罕見病問題,Marc 將回答這確實是我們可以產生的協同效應的一個很好的例證。我的意思是,正如 Ruud 解釋 AndexXa 的那樣,我們正在重新啟動,我們認為我們在心血管疾病方面的規模將對我們有所幫助。但我們也在努力降低商品成本,這一直是一個障礙。 AZ 和 Alexion 團隊正在共同努力降低商品成本。 Marc 一直與我們的運營主管 Pam Cheng 一起領導這項工作。我們正在取得良好的進展。那麼這兩家公司之間非常好的協同作用的一個明顯例子,馬克?
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Yes, let me maybe add to what Ruud was saying, I mean, we're also very happy with the recent good news of approval in Japan with a full approval and price negotiations look also reasonable and the latest information I had from physicians and hospitals is that they are really expecting this specific antidote for Factor Xa inhibition bidding. So let's go now to the other question, which was basically the impact of rare disease in the Emerging Market as we see today.
是的,讓我補充一下 Ruud 所說的話,我的意思是,我們也很高興最近在日本獲得批准的好消息,獲得了全面批准,價格談判看起來也很合理,而且我從醫生和醫院獲得的最新信息是他們真的期待這種針對 Xa 因子抑制投標的特定解毒劑。那麼現在讓我們談談另一個問題,這基本上是我們今天看到的新興市場罕見病的影響。
Today, if we look at the first quarter, this is obviously on a given year, an increase in the growth -- it has increased the growth rate. But I also want to -- which is basically in line with what has been done by the Alexion company for many years. But I also want to cover a topic that we had addressed when we made the announcement where we said we would accelerate the development of our innovations in China, and I can report that we have made very good progress on Soliris in several indications, and we do expect approval maybe towards the end of this year or early next year in a set of indications for Soliris. And this would be the first C5 inhibitor with the ability to treat several indications in China.
今天,如果我們看第一季度,這顯然是給定年份的增長增長——它提高了增長率。但我也想——這基本上與 Alexion 公司多年來所做的一致。但我還想談一談我們在宣布將加速在中國的創新發展時所討論的話題,我可以報告說,我們在 Soliris 方面取得了非常好的進展,並且我們確實預計可能會在今年年底或明年年初批准 Soliris 的一系列跡象。這將是中國第一個能夠治療多種適應症的C5抑製劑。
We are also now trying to have China participate in global studies so that we don't have the same time line between the Rest of The World. So great progress being made in Emerging Markets. And obviously, as far as Alexion is concerned, we see AstraZeneca has an extraordinary opportunity to leverage this global reach and global presence, and we will take advantage of it.
我們現在也在努力讓中國參與全球研究,這樣我們就不會在世界其他地方有相同的時間線。新興市場取得瞭如此巨大的進步。顯然,就亞力兄而言,我們看到阿斯利康有一個非凡的機會來利用這一全球影響力和全球影響力,我們將利用它。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Marc. And Iskra, if you want to cover the question about Vaxzevria sales in the second half.
謝謝,馬克。還有《火星報》,如果您想在下半年討論有關 Vaxzevria 銷售的問題。
Iskra Reic - Executive Vice-President of Vaccines & Immune Therapies
Iskra Reic - Executive Vice-President of Vaccines & Immune Therapies
Thanks for the question. So as mentioned previously, the first and second quarter of Vaxzevria sales represent our fulfillment of the initial or non-for-profit contracts. We do expect some subsequent commercial contracts that will happen. And as we guided previously, that will be on the affordable price that will allow us to maintain the [growth to] global access. But I think given the fact that there is no scarcity of the vaccines in the world today, it is reasonable to guide that we will see a significant decline with Vaxzevria sales in the second part of the year.
謝謝你的問題。因此,如前所述,Vaxzevria 第一季度和第二季度的銷售代表了我們對初始或非營利性合同的履行。我們確實預計會發生一些後續的商業合同。正如我們之前所指導的那樣,這將以可承受的價格為基礎,使我們能夠保持全球訪問的[增長]。但我認為,鑑於當今世界上疫苗並不稀缺,我們可以合理地指導我們將在今年下半年看到 Vaxzevria 的銷售顯著下降。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks. It's a very important point. I think you still read articles about the lack of vaccines doses. Today, the issue is not scarcity of vaccine. It's oversupply, and I'm sure you've seen a number of other companies announcing a reduction in their forecast because there is suddenly oversupply at the present time.
謝謝。這是非常重要的一點。我認為您仍然會閱讀有關缺乏疫苗劑量的文章。今天,問題不在於疫苗稀缺。這是供過於求,我相信你已經看到許多其他公司宣布下調他們的預測,因為目前突然出現供過於求。
Christopher Uhde, I hope I'm not hurting your name actually, Christopher, do you want to go ahead?
Christopher Uhde,我希望我沒有傷害你的名字,Christopher,你想繼續嗎?
Christopher Winston Uhde - Analyst
Christopher Winston Uhde - Analyst
Christopher Uhde from SEB. So I guess my first question is on nirsevimab, actually. I just wondered whether you are considering exploring that in immunocompromised patients as you have Evusheld. Obviously, I guess, we see from, for example, Synagis that dose splitting doesn't really happen. So I guess, the limited risk of impacts to the business plan for children. And then my second question, on the PARP1, can you talk about your expectations on how you see its utility in ovarian, breast and prostate compared to PARP2, besides just -- I mean, in terms of are there subsets of patients that might be more or less -- might be less, let's say, susceptible to PARP1 inhibition. In particular, I'm wondering about -- there seems to be some level of controversy in prostate cancer. I've seen a publication in PNAS, for example, saying that it's PARP2 and not PARP1 that mediates the repair in prostate.
來自 SEB 的 Christopher Uhde。所以我想我的第一個問題實際上是關於 nirsevimab。我只是想知道您是否正在考慮像 Evusheld 一樣在免疫功能低下的患者中進行研究。顯然,我猜,我們從例如 Synagis 中看到,劑量分割並沒有真正發生。所以我想,對兒童商業計劃的影響風險有限。然後我的第二個問題,關於 PARP1,您能否談談您對與 PARP2 相比如何看待它在卵巢、乳腺和前列腺中的效用的期望,除了 - 我的意思是,就可能存在的患者亞群而言或多或少——比方說,可能更少受到 PARP1 抑制的影響。特別是,我想知道 - 前列腺癌似乎存在一定程度的爭議。例如,我在 PNAS 上看過一篇文章,說是 PARP2 而不是 PARP1 介導了前列腺的修復。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
So Iskra, sorry, do you want to take the first question on nirsevimab?
所以 Iskra,對不起,你想回答關於 nirsevimab 的第一個問題嗎?
Iskra Reic - Executive Vice-President of Vaccines & Immune Therapies
Iskra Reic - Executive Vice-President of Vaccines & Immune Therapies
So let me first say that we are very pleased with the strong profile of nirsevimab that we saw in the recently published MEDLEY and MELODY Phase III clinical studies. And we are very convinced and feel comfortable that it has a really great profile for the protection of the RSV in infants.
因此,我首先要說,我們對我們在最近發表的 MEDLEY 和 MELODY III 期臨床研究中看到的 nirsevimab 的強大形象感到非常滿意。我們非常確信並感到舒適,它在保護嬰兒 RSV 方面具有非常好的作用。
But I think you are raising an important point. And I think during the COVID-19 crisis specifically, we did learn the importance of protection of the immunocompromised group of patients. And as we already have experience and with the Evusheld, it is very fair to say that this is important indication to explore. So we are definitely looking at the option how nirsevimab will be -- how we will use the profile of the -- strong profile of the nirsevimab potentially beyond the current indication. And we'll obviously guide and inform the due time.
但我認為你提出了一個重要的觀點。我認為,特別是在 COVID-19 危機期間,我們確實了解了保護免疫功能低下患者群體的重要性。並且由於我們已經擁有 Evusheld 的經驗,因此可以非常公平地說,這是值得探索的重要跡象。因此,我們肯定會考慮 nirsevimab 的選擇——我們將如何使用 nirsevimab 的強大配置文件,這可能超出當前的適應症。我們顯然會在適當的時候指導和通知。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Susan, the PARP1.
蘇珊,PARP1。
Susan Mary Galbraith - EVP of Oncology Research & Development
Susan Mary Galbraith - EVP of Oncology Research & Development
Yes. So we've looked at the activity of our PARP1-selective molecule in a range of different preclinical prostate models, and we see very good activity in that setting.
是的。因此,我們在一系列不同的臨床前前列腺模型中觀察了我們的 PARP1 選擇性分子的活性,並且我們看到了在這種情況下非常好的活性。
In fact, actually, if you look in the segment of prostate cancers that are driven by ATM mutations and remember the profound data, the level of activity that we saw in BRCA-mutant patients was higher than was seen in the ATM-mutant -- actually PARP1-selective looks better than olaparib in that segment of patients with an ATM mutation, for example. And I would also just point out that in the Phase I PETRA data that we saw at AACR, there was activity also seen in prostate cancer patients that we've seen.
事實上,實際上,如果你查看由 ATM 突變驅動的前列腺癌部分並記住深刻的數據,我們在 BRCA 突變患者中看到的活動水平高於在 ATM 突變患者中看到的——實際上,例如,在具有 ATM 突變的那部分患者中,PARP1 選擇性看起來比奧拉帕尼更好。我還想指出,在我們在 AACR 看到的 I 期 PETRA 數據中,我們看到的前列腺癌患者也有活動。
So I'm confident about the profile across the range of indications where we already know that PARP inhibitors work. And again, I think there's great potential to go beyond where we currently got indications.
因此,我對我們已經知道 PARP 抑製劑有效的各種適應症的概況充滿信心。再說一次,我認為有很大的潛力可以超越我們目前的跡象。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Susan. So we have one more question from Mattias Häggblom at Handelsbanken. Mattias, over to you.
謝謝,蘇珊。因此,我們還有一個來自 Handelsbanken 的 Mattias Häggblom 的問題。馬蒂亞斯,交給你了。
Mattias Häggblom - Research Analyst
Mattias Häggblom - Research Analyst
I'll be brave and go with 2. Firstly, on the performance of rare disease, I think Marc has previously reminded us of the tough comps for Alexion in the first half, given how Alexion performed last year before being consolidated. So that said, can you confirm that we should still expect the rare disease unit to remain nondilutive to the double-digit growth you see for the group until 2025? And is there anything in particular that will get you back to trend? And then secondly, for the newly formed disease area of V&I, for 2 of the molecules in this area, Synagis and nirsevimab, you don't have global rights. For one of them, there's even 3 business partners. Now this disease area formed, is this a priority to resolve and consolidate the ownership? Or given have you used partnerships in other areas including oncology? Is this a model with split ownership, something we should continue to expect from you?
我會勇敢地選擇2。首先,關於罕見病的表現,我認為Marc之前已經提醒我們Alexion在上半年的艱難表現,因為Alexion去年在合併之前的表現。話雖如此,您能否確認我們仍應期望罕見病部門在 2025 年之前對您看到的該集團的兩位數增長保持非稀釋性?有什麼特別的東西可以讓你回歸潮流嗎?其次,對於 V&I 新成立的疾病領域,對於該領域的 2 個分子,Synagis 和 nirsevimab,你沒有全球權利。其中一個,甚至還有3個商業夥伴。現在這個病區形成了,是不是要優先解決和鞏固所有權?或者考慮到您是否在包括腫瘤學在內的其他領域使用過合作夥伴關係?這是一個所有權分割的模型,我們應該繼續期待你嗎?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
The first question, I think, rare disease, Mattias, if I may jump in here. We've never guided on Alexion per se. We've said that the 2 companies together would grow at low double digit. And I think that's probably as much as we would want to say at this time. Unless Marc, do you want to add anything?
第一個問題,我想,罕見病,Mattias,請允許我跳到這裡。我們從未指導過 Alexion 本身。我們已經說過,這兩家公司一起將以低兩位數的速度增長。我認為這可能就是我們此時想說的。除非馬克,你想添加什麼嗎?
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
Marc Dunoyer - CEO of Alexion & Chief Strategy Officer
No. This is the trajectory.
不,這是軌跡。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Exactly. The second question, Iskra, do you want to comment on that?
確切地。第二個問題,火星報,你想對此發表評論嗎?
Iskra Reic - Executive Vice-President of Vaccines & Immune Therapies
Iskra Reic - Executive Vice-President of Vaccines & Immune Therapies
Yes. I can comment. I mean, we are obviously working in different type of partnerships across the portfolio and the similar cases with our portfolio for RSV, for both Synagis and nirsevimab. I think the collaborative partnership -- collaboration in the partnership is something that we always try to foresee. And I think at the end, it's really about the unmet clinical needs and importance of the medicine and the asset and that usually pays off in the different partnerships.
是的。我可以發表評論。我的意思是,我們顯然正在與我們的 RSV 產品組合、Synagis 和 nirsevimab 的產品組合中建立不同類型的合作夥伴關係以及類似的案例。我認為合作夥伴關係——合作夥伴關係中的合作是我們一直試圖預見的事情。我認為最後,這實際上是關於未滿足的臨床需求以及藥物和資產的重要性,這通常會在不同的合作夥伴關係中得到回報。
As I mentioned before, we are very -- we are very convinced in the strong profile of nirsevimab, particularly, as you know, the unmet need in the RSV in infant space is really huge across the globe. We see the -- quite a number of the hospitalization and that in the infants, but also the huge burden on the health care systems and the cost that goes above $5 billion.
正如我之前提到的,我們非常 - 我們非常相信 nirsevimab 的強大形象,特別是,如您所知,RSV 在嬰兒空間中的未滿足需求在全球範圍內確實是巨大的。我們看到 - 相當多的住院和嬰兒住院,但也看到醫療保健系統的巨大負擔和超過 50 億美元的成本。
So if you think about that and having the molecule that can prevent the medically (inaudible) respiratory tract infection in the infants is something that will hopefully also help us to drive and lead in these collaborations and partnerships that sometimes can be, as you mentioned, with a number of partners across the globe.
因此,如果您考慮到這一點,並且擁有可以預防嬰兒在醫學上(聽不清)呼吸道感染的分子,這有望幫助我們推動和領導這些有時可能是的合作和夥伴關係,正如您提到的,與全球眾多合作夥伴。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Iskra. So maybe we could actually close for today. Thank you so much for all your interest and your great questions. And as you could see from hopefully the presentations, but also the discussions to questions, we have a very busy agenda for 2022, and we are going to continue investing in our pipeline and build long-term growth, we believe we can grow at a pretty good rate, what we've called industry-leading growth rate post '25, and that will really depend on the growth we are driving today but also new growth we generate through our pipeline. So importantly, the message is we are committed to science, and we'll continue to invest in our pipeline.
謝謝,火星報。所以也許我們今天實際上可以關閉。非常感謝您的所有興趣和您的好問題。正如您希望從演示文稿以及對問題的討論中看到的那樣,我們 2022 年的議程非常繁忙,我們將繼續投資於我們的管道並建立長期增長,我們相信我們可以在相當不錯的增長率,我們稱之為 25 年後行業領先的增長率,這將真正取決於我們今天推動的增長,以及我們通過管道產生的新增長。如此重要的是,傳達的信息是我們致力於科學,我們將繼續投資於我們的管道。
With this, thank you so much, and I wish you all a good weekend.
有了這個,非常感謝你們,祝大家週末愉快。