演講者討論了公司在 2024 年的強勁表現,包括收入和每股收益的大幅增長、產品線的進步以及到 2030 年推出 20 種新藥的目標。 他們強調了治療領域和地域的增長、在中國正在進行的研究以及在腫瘤學、生物製藥、罕見疾病和新興市場繼續增長的計劃。
該公司專注於透過對研發和變革性技術的投資來實現策略目標。討論還涉及中國市場份額、交易相關付款、毛利率以及各個治療領域的挑戰和機會。該公司對未來的成長和市場領導地位持樂觀態度。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning to those joining from the UK and the US.
來自英國和美國的與會者早安。
Good afternoon to those in Central Europe, and good evening to those listening in Asia.
中歐地區的聽眾們下午好,亞洲地區的聽眾們晚上都很好。
Welcome, ladies and gentlemen, to AstraZeneca's full year and Q4 2024 results conference call for investors and analysts.
女士們、先生們,歡迎參加阿斯特捷利康針對投資者和分析師的 2024 年全年和第四季度業績電話會議。
Before I hand over to AstraZeneca, I'd like to read the safe harbor statement.
在交給阿斯特捷利康之前,我想先讀安全港聲明。
The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995.
該公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。
Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.
本次電話會議的參與者可能會對阿斯特捷利康的營運和財務表現做出前瞻性陳述。
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.
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,並且可能受到導致實際結果與這些前瞻性陳述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.
本次電話會議中所做的任何前瞻性陳述均反映本次電話會議時所掌握的知識和資訊。
The company undertakes no obligation to update forward-looking statements.
該公司不承擔更新前瞻性陳述的義務。
Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this meeting.
請仔細閱讀本次會議附帶的幻燈片中的前瞻性聲明免責聲明。
(Operator Instructions) I must advise you that this presentation is being recorded today.
(操作員指示)我必須通知您,今天正在錄製此演示。
And with that, I will now hand you over to the company.
說完這些,我現在將你交給公司。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you, Andy.
謝謝你,安迪。
Welcome, everybody.
歡迎大家。
It's great to see you all here today.
我很高興今天在這裡見到大家。
Next slide, please. 2024 was a very strong year for our company, I would say, very, very amazing year, I have to say, with total revenue up 21% and our core EPS up 19%, as you can see here, a clear illustration of the strong underlying momentum of the company.
請看下一張投影片。 2024 年對我們公司來說是非常強勁的一年,我想說,非常非常令人驚嘆的一年,我不得不說,總收入增長了 21%,我們的核心每股收益增長了 19%,正如您在這裡看到的,這清楚地說明了公司強勁的潛在發展勢頭。
I've also listed here 14% on core OpEx to show that we continue to work on leverage with a lower growth of our expenses relative to the growth of our total revenue.
我還在這裡列出了核心營運支出的 14%,以表明我們繼續努力利用槓桿,使支出成長相對於總收入的成長較低。
We also delivered important pipeline advancements with nine high-value pivotal trials with 2024.
我們也於 2024 年實現了九項高價值關鍵試驗的重要進展。
Combined, this trial represents over $5 billion in nonrisk-adjusted peak revenue.
總計此次試驗的非風險調整高峰收入超過 50 億美元。
We had, of course, readouts than those nine.
當然,我們還有比這九個更多的讀數。
But those are the most high-value readouts we had last year.
但這些是我們去年得到的最有價值的讀數。
At our Investor Day in May, we communicated our ambition to deliver 20 new medicines by 2030.
在五月的投資者日上,我們表達了 2030 年推出 20 種新藥的宏偉目標。
And I'm pleased to report that we have new -- we have eight new medicines approved to date, including the recent approval of Datroway, which was previously called Dato-DXd earlier this year.
我很高興地報告,我們迄今已批准了 8 種新藥,包括今年稍早批准的 Datroway(原名為 Dato-DXd)。
So if you move to the next slide.
因此請移至下一張投影片。
We continue to benefit from our broad-based portfolio of products in diverse geography.
我們繼續受益於遍布不同地區的廣泛產品組合。
And we have strong growth across all our therapy areas, as you can see here in key geographies in 2024.
正如您在 2024 年的主要地區所看到的那樣,我們所有的治療領域都實現了強勁增長。
In the year ahead, we anticipate sustained demand for our innovative medicines and our growth across geographies.
在未來的一年裡,我們預計我們的創新藥物的需求將持續成長並且我們在各個地區的業務都將成長。
In our results announcement, we provided an update on ongoing investigations in China.
在我們的業績公告中,我們提供了中國正在進行的調查的最新情況。
We've received notification from the Shenzhen City Customs Office regarding suspected unpaid importation taxes totaling $900,000 which, to the best of our knowledge, relates to Imfinzi and Imjudo.
我們收到深圳市海關的通知,涉嫌拖欠進口稅 90 萬美元,據我們所知,該款項與 Imfinzi 和 Imjudo 有關。
So if actually AstraZeneca was found liable, a fine of between 1 to 5 times of avoided import duties could have to be paid by AstraZeneca.
因此,如果阿斯特捷利康確實被判有罪,阿斯特捷利康可能需要支付相當於所逃進口關稅 1 至 5 倍的罰款。
We are continuing to cooperate with the government towards resolution of those investigations.
我們將繼續與政府合作解決這些調查。
I'm pleased to have Iskra, we call her Super Iskra, joining us today in her new role as Head of International, I would now like to invite Iskra to share early perspectives on her new job and, in particular, China.
我很高興伊斯克拉,我們稱她為超級伊斯克拉,今天加入我們,擔任國際業務主管的新職務,現在我想請伊斯克拉分享她對新工作,特別是中國市場的初步看法。
Over to you, Iskra.
交給你了,伊斯克拉。
Iskra Reic - Executive Vice President - International
Iskra Reic - Executive Vice President - International
Thank you, Pascal.
謝謝你,帕斯卡。
No pressure with the nickname.
暱稱沒什麼壓力。
I'm very honored to have assumed responsibilities in the international region that, as you all know, combined emerging markets as well as Australia and New Zealand.
我很榮幸能夠在國際區域承擔職責,眾所周知,這個區域包括新興市場以及澳洲和紐西蘭。
Initially, when I started in my new role, my focus was really in how best to support our colleagues in China at the unsettling time for them.
最初,當我開始擔任新職務時,我的重點實際上是如何在中國同事困難時期為他們提供最好的支援。
And I have been really truly impressed by their continued efforts and passion to deliver on the values and our purpose.
他們為實現價值觀和目標而持續的努力和熱情給我留下了深刻的印象。
And I have a real strong confidence in the leadership that we have in place in China.
我對我們在中國的領導階層充滿信心。
China revenues last year had increased by 15% throughout the first nine months.
去年前九個月,中國市場收入成長了 15%。
And overall year 2024 growth is 11% because of the quarter four decline of 3%.
由於第四季下降了 3%,因此 2024 年的整體成長率為 11%。
It is very important to note that that decline was primarily driven by year-end hospital ordering dynamic, which affected a few products, specifically Tagrisso and Farxiga as well as demand for our respiratory products that is lower given the mild start of the winter.
值得注意的是,這種下降主要是由於年底醫院訂單動態所致,這影響了一些產品,特別是 Tagrisso 和 Farxiga,並且由於冬季開始時氣候溫和,對我們的呼吸產品的需求也較低。
And while we do expect some headwinds specifically driven by DBP inclusion for our several medicines, we do expect the growth in China, they'll continue.
儘管我們確實預計我們的幾種藥物中包含 DBP 會帶來一些不利因素,但我們確實預計中國市場的成長將會持續下去。
And especially longer term, they see a strong opportunity, and we are fully committed to continue growing in China.
特別是從長期來看,他們看到了巨大的機遇,而我們也完全致力於繼續在中國發展。
If I think about emerging markets more broadly.
如果我更廣泛地考慮新興市場。
I think you all know that we shall be building our presence and capabilities for many years, accelerating our regulatory approvals and also doing our best to broaden our equitable access, and we have seen strong growth over the past several years and we do expect that growth to continue.
我想大家都知道,我們將在未來很多年裡繼續建立我們的業務和能力,加快我們的監管審批,並盡最大努力擴大我們的公平准入,我們在過去幾年中看到了強勁的增長,我們確實預計這種增長將繼續下去。
In 2024, overall emerging market growth was at 22%.
2024年,新興市場整體成長率為22%。
The unmet need across the emerging markets is unprecedented or enormous.
新興市場中未滿足的需求是前所未見的,甚至是巨大的。
I mean, if you look at any therapy area, but specifically if you look at the areas where we work, just to give you one example, in emerging markets, it's estimated that 1.8 million people will be diagnosed with lung cancer.
我的意思是,如果你看看任何治療領域,但具體到我們工作的領域,舉一個例子,在新興市場,估計有 180 萬人將被診斷出患有肺癌。
That represents actually 70% of the overall lung cancer diagnosis over the -- in the globe.
這實際上佔了全球肺癌診斷總數的 70%。
The substantial unmet need, coupled with the increased investment in the healthcare as well as increased willingness to pay for the healthcare, gives us an opportunity to deliver a significant growth going forward.
大量未滿足的需求,加上對醫療保健的投資增加以及支付醫療保健費用的意願增強,為我們提供了在未來實現顯著增長的機會。
Thank you.
謝謝。
Please advance to the next slide, and I will give floor back to Pascal.
請進入下一張投影片,我將發言權交還給帕斯卡。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you, Iskra.
謝謝你,Iskra。
So as you heard from Iskra, this enormous opportunities in the emerging markets, not only in China but also outside of China and Iskra knows where.
正如您從 Iskra 那裡聽到的,新興市場中存在著巨大的機遇,不僅在中國,而且在中國以外,Iskra 知道在哪裡。
So we'll definitely have a big impact on our future growth, and we look forward to resolving the issues that we've been facing in China, of course.
因此,我們肯定會對我們未來的發展產生重大影響,當然,我們期待解決我們在中國面臨的問題。
2025 marks the beginning of an unprecedented catalyst-rich period for our company.
2025年,對於我們公司來說,將迎來一個前所未有的催化劑豐富時期。
We have talked about it before.
我們之前已經討論過它了。
We're looking forward to the results of high-value trial readouts this year for several of our existing medicines, including Enhertu, Datroway, Imfinzi, Breztri, and Fasenra.
我們期待今年我們現有的幾種藥物的高價值試驗結果,包括 Enhertu、Datroway、Imfinzi、Breztri 和 Fasenra。
And importantly, we also anticipate the first Phase 3 data for seven NMEs, seven, including camizestrant and baxdrostat, two medicines with each have a potential to generate more than $5 billion in fixed revenue.
重要的是,我們還預計有七種 NME 的首批 3 期數據,其中包括 camizestrant 和 baxdrostat,每種藥物都有可能產生超過 50 億美元的固定收入。
The value of our pipeline has been increasing steadily.
我們的管道價值一直在穩步增長。
And as Aradhana communicated earlier this year, we now have more than 90, nine zero, late-stage trials underway with an average nonrisk-adjusted peak revenue per trial over $1 billion.
正如 Aradhana 今年稍早所傳達的那樣,我們目前有 90 多個九零後後期試驗正在進行中,每個試驗的平均非風險調整高峰收入超過 10 億美元。
Looking only on the -- at the anticipated readouts, if I've shown here taken together, this represents over $15 billion in nonrisk-adjusted peak revenue potential.
僅從預期的讀數來看,如果我在這裡綜合展示的話,這代表著超過 150 億美元的非風險調整峰值收入潛力。
And that's why we have said a few times, by the end of this year, early 2026, everybody will have a good sense as to our chances to get to the $80 billion.
這就是為什麼我們多次說過,到今年年底,也就是 2026 年初,每個人都會很清楚地知道我們達到 800 億美元的機會。
You'll see the momentum that we have in our company, plus you will see the outcomes of those trials.
您將會看到我們公司的發展勢頭,同時您也將看到這些試驗的成果。
With that, please advance to the next slide, and Aradhana now will take you through our financials.
請進入下一張投影片,Aradhana 將帶您了解我們的財務狀況。
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
Thank you, Pascal, and good morning, everyone.
謝謝你,帕斯卡,大家早安。
As usaul, we'll start with reported P&L.
像往常一樣,我們將從報告損益表開始。
Next slide, please.
請看下一張投影片。
As Pascal highlighted, our company delivered very strong performance in 2024.
正如帕斯卡所強調的,我們公司在 2024 年的業績非常強勁。
Total revenue grew by 25% in the fourth quarter with full year revenues up 21%, exceeding our twice updated guidance range of high-teens percentage increase.
第四季總營收成長 25%,全年營收成長 21%,超過了我們兩次更新的高位數百分比增幅指導範圍。
Product sales grew by 19% in the full year driven by strong underlying demand for our medicines across regions.
由於各地區對我們藥品的強勁需求,全年產品銷售額成長了 19%。
Alliance revenue increased by 55%, reflecting demand for an Enhertu and Tezpire in regions where our partners booked product sales.
聯盟收入成長了 55%,反映了我們的合作夥伴預訂產品銷售的地區對 Enhertu 和 Tezpire 的需求。
Collaboration revenue increased by 54% driven primarily by a $600 million Lynparza sales milestone recognized in the fourth quarter as well as smaller sales milestones for the Beyfortus and Koselugo.
合作收入成長了 54%,主要得益於第四季度實現的 6 億美元 Lynparza 銷售里程碑以及 Beyfortus 和 Koselugo 的較小銷售里程碑。
Next slide, please.
請看下一張投影片。
This is our core P&L.
這是我們的核心損益。
Our core product sales gross margin in 2024 was 81.2%, in line with our indication for a slight decrease compared to full year 2023.
我們 2024 年的核心產品銷售毛利率為 81.2%,與我們的預測相符,即與 2023 年全年相比略有下降。
Core operating expense increased by 14% in 2024, well below the top line growth of 21%.
2024 年核心營運費用成長 14%,遠低於 21% 的營收成長率。
Core R&D expense increased by 19% and consistent with our prior commentary as a percentage of total revenue, core R&D expense was towards the upper end of the low 20s percentage range.
核心研發費用增加了 19%,與我們先前對總收入百分比的評論一致,核心研發費用接近 20% 左右的百分比範圍的上限。
This increase supported multiple new trial starts, including Phase 2 trial starts for our weight management portfolio and the acceleration of our cell therapy programs.
這一增長支持了多個新試驗的啟動,包括我們體重管理產品組合的第 2 階段試驗的啟動以及我們細胞療法計劃的加速。
It also reflects costs following the closure of several business development transactions in 2024.
它也反映了 2024 年完成幾項業務發展交易後產生的成本。
Core SG&A costs increased by 11%, reflecting continued investments behind launching brands.
核心銷售、一般及行政開支增加了 11%,反映出推出品牌背後持續的投資。
SG&A decreased to 28% of total revenue on a full year basis.
銷售、一般及行政開支佔全年總收入的比重下降至 28%。
Other operating income declined significantly as we booked more than $700 million in 2023 relating to the update of the contractual agreement on the Beyfortus as well as $250 million relating to the US divestment of Pulmicort.
其他營業收入大幅下降,因為我們在 2023 年預訂了超過 7 億美元與 Beyfortus 合約協議更新相關的費用,以及 2.5 億美元與美國剝離 Pulmicort 相關的費用。
Core EPS of $8.21 represents 19% growth placed at the top end of our full year guidance.
核心每股收益為 8.21 美元,代表著 19% 的成長率,處於我們全年預期的最高水平。
Next slide, please.
請看下一張投影片。
Our net cash flow from operating activities increased by $1.5 billion in 2024.
2024 年,我們的營運活動淨現金流增加了 15 億美元。
CapEx of $2.2 billion was broadly in line with the indication of a 50% projected increase over 2023.
22 億美元的資本支出與預計 2023 年將成長 50% 的預期基本一致。
This includes both tangible and software-related intangible assets.
這包括有形資產和與軟體相關的無形資產。
We completed a number of business development transactions in 2024, including the acquisition of Amolyt, Icosavax, and Fusion and incurred total debt payments close to $7 billion.
我們在 2024 年完成了多項業務發展交易,包括收購 Amolyt、Icosavax 和 Fusion,總債務支付額接近 70 億美元。
We anticipate due payments relating to past transactions of approximately $3 billion in 2025.
我們預計 2025 年與過去交易相關的應付款項約為 30 億美元。
Net debt increased by $2.1 billion to $24.6 billion, which is a level we are comfortable with.
淨債務增加了 21 億美元,達到 246 億美元,這是我們可以接受的水平。
Given the growth in our EBITDA, our current net debt-to-EBITDA ratio stands at 1.5 times.
鑑於我們的 EBITDA 成長,我們目前的淨負債與 EBITDA 比率為 1.5 倍。
We increased the full year 2024 dividend to $3.10 per share and announced this morning that we intend to increase our full year 2025 dividend to $3.20. Today, we issued guidance for 2025 and expect total revenue to increase by a high single-digit percentage and core EPS to increase by low double-digit percentage.
我們將 2024 年全年股息提高至每股 3.10 美元,並於今天上午宣布,我們打算將 2025 年全年股息提高至 3.20 美元。今天,我們發布了 2025 年的指引,預計總收入將以高個位數百分比成長,核心每股收益將以低兩位數百分比成長。
We anticipate our strong growth momentum to continue in 2025, more than offsetting the headwinds that we have previously indicated.
我們預計,強勁的成長勢頭將在 2025 年持續下去,並足以抵消我們先前指出的不利因素。
These dynamics also adversely impact our product sales growth margin, and we anticipate an incremental 60 to 70 basis points decline driven by the net effect of the IRA in the US, the anticipated inclusion in [VBP] of Farxiga, Lynparza in China as well as the growth of our partnered products that have lower gross margins.
這些動態也對我們的產品銷售成長利潤率產生了不利影響,我們預計,受美國 IRA 的淨效應、Farxiga 和 Lynparza 預計納入 [VBP] 以及我們合作產品的成長(這些產品的毛利率較低)的推動,產品銷售成長利潤率將下降 60 至 70 個基點。
Operating leverage remains a priority for our company.
經營槓桿仍然是我們公司的首要任務。
We continue to anticipate SG&A costs to grow at a slower pace than revenue.
我們繼續預期銷售、一般及行政費用的成長速度將低於收入的成長速度。
We are beginning to see benefits from the redeployment of our global footprint and continue to optimize our commercial investments across key disease areas to support new launches.
我們開始看到重新部署全球業務的好處,並繼續優化我們在主要疾病領域的商業投資以支持新產品的推出。
R&D expenses are expected to remain in the low 20s percentage range of total revenue.
預計研發費用將維持在總收入的20%左右。
Our full year guidance is, as usual, at constant exchange rates.
與往常一樣,我們的全年預期是基於固定匯率。
Based on average January 2025 rates, we anticipate a low single-digit adverse FX impact on total revenue and a mid-single-digit adverse impact on core EPS.
根據 2025 年 1 月的平均匯率,我們預期外匯將對總收入產生低個位數的不利影響,對核心每股盈餘產生中等個位數的不利影響。
The recent strengthening of the US dollar also affect our core operating margin percentage, and we estimate an adverse impact of roughly 20 basis points in 2025 based on average January 2025 FX rates compared to average rates for full year 2024 and roughly 50 basis points as compared to average FX rates in first quarter 2024.
美元近期走強也影響了我們的核心營業利潤率百分比,根據 2025 年 1 月的平均外匯匯率,我們估計,與 2024 年全年平均匯率相比,2025 年將產生約 20 個基點的不利影響,與 2024 年第一季度的平均外匯匯率相比,將產生不利的影響。
Please turn to next slide.
請翻到下一張投影片。
In 2025, we expect expenditure on tangible and software-related intangible assets to increase by approximately 50%, driven by manufacturing expansion projects and investments in systems and technology that will support our long-term growth ambitions.
2025 年,我們預計有形資產和軟體相關無形資產的支出將增加約 50%,這主要得益於製造擴張項目以及支持我們長期成長目標的系統和技術投資。
Today, we have a diverse and resilient supply chain with 26 production facilities in 15 countries that affords us optionality and agility while addressing global demand for our medicines.
今天,我們擁有多元化、有彈性的供應鏈,在 15 個國家設有 26 個生產設施,為我們提供可選性和靈活性,同時滿足全球對我們藥品的需求。
The increased manufacturing investments we are making include investments into next-generation capabilities for both small molecules and large molecules as well as transformative technologies such as ADCs, cell therapies, and oligonucleotides globally.
我們增加的製造業投資包括對小分子和大分子的下一代能力以及全球 ADC、細胞療法和寡核苷酸等變革性技術的投資。
Already in progress are a new end-to-end ADC manufacturing site in Singapore, a cell therapy manufacturing site in Rockville, Maryland and an API facility in Dublin, Ireland and a site in Qingdao, China for inhaled therapies.
目前已興建中的設施包括:位於新加坡的全新端對端 ADC 製造基地、位於馬裡蘭州羅克維爾的細胞療法製造基地、位於愛爾蘭都柏林的 API 工廠以及位於中國青島的吸入療法工廠。
In November last year, we also announced several investments in the US, including a specialty manufacturing facility in Texas.
去年 11 月,我們還宣布了在美國進行的幾項投資,包括位於德克薩斯州的專業製造工廠。
All of these are multiyear projects that illustrate how we are supporting our growing pipeline, including drivers of growth post 2030.
所有這些都是多年期項目,說明了我們如何支持不斷增長的項目管道,包括2030年後的成長動力。
Lastly, we are upgrading our data and ERP systems to set the data foundation to support our growth and enable us to more fully leverage innovation in AI and make our business more efficient.
最後,我們正在升級我們的數據和 ERP 系統,以奠定數據基礎來支持我們的成長,並使我們能夠更充分地利用人工智慧創新,使我們的業務更有效率。
With that, please turn to the next slide, and I will hand over to Dave, who will take you through the Oncology performance.
說完這些,請翻到下一張投影片,我將把麥克風交給戴夫,他將帶大家了解腫瘤學的表現。
David Fredrickson - Executive Vice President - Oncology Business Unit
David Fredrickson - Executive Vice President - Oncology Business Unit
Thank you very much, Aradhana.
非常感謝,Aradhana。
Next slide, please.
請看下一張投影片。
So in 2024, Oncology delivered total revenues of $22.4 billion, which was an impressive increase of 24% with key medicines surpassing new multi-blockbuster milestones with Tagrisso achieving over $6.5 billion, Lynparza over $3 billion in product sales, Imfinzi and Imjudo combined approaching $5 billion, Calquence and Enhertu achieving over in $2 billion in full year revenues respectively.
因此,在 2024 年,腫瘤學的總收入達到 224 億美元,成長了 24%,其中主要藥物超越了新的多重重磅藥物里程碑,其中 Tagrisso 實現超過 65 億美元的收入,Lynparza 的產品銷售額超過 30 億美元,Imfinzi 和 Imjudo 的總收入接近 50 億美元,Cal 20 億美元,Cal 20 億美元的總收入。
This strong growth really does signal clear progress on our mission to deliver medicines with potential to transform outcomes for patients globally.
這一強勁成長確實標誌著我們在為全球患者提供可能改變治療結果的藥物的使命上取得了顯著進展。
Turning now to fourth quarter performance for our key medicines.
現在來談談我們主要藥品第四季的表現。
Tagrisso global revenues grew 21%, reflecting strong growth across all indications, partly offset by the customary fourth quarter hospital ordering dynamics that you heard about earlier in China.
Tagrisso 的全球收入成長了 21%,反映了所有適應症的強勁增長,但部分被您之前在中國聽到的第四季度醫院常規訂購動態所抵消。
In the frontline setting, Tagrisso achieved over 75% market share globally, with close to 85% market share in the US.
在第一線治療領域,Tagrisso 在全球佔據了超過75%的市場份額,在美國更是佔據了近85%的市場份額。
We continue to make steady gains in the adjuvant setting with ADAURA and saw encouraging early launch uptake for LAURA in early-stage unresectable lung cancer.
我們繼續透過 ADAURA 在輔助治療領域取得穩步進展,並看到 LAURA 在早期不可切除肺癌治療中的早期上市應用令人鼓舞。
Calquence total revenues increased 20% in the fourth quarter, driven by sustained BTK inhibitor leadership in the frontline CLL setting and contingent expansion in the face of pretty fierce competition.
第四季度,Calquence 總收入成長了 20%,這得益於 BTK 抑制劑在一線 CLL 領域持續的領導地位以及在相當激烈的競爭條件下的持續擴張。
In the fourth quarter, Imfinzi and Imjudo delivered 18% and 28% growth respectively, reflecting continued demand across lung and liver cancer in the US as well as accelerating adoption of TOPAZ through HIMALAYA in Europe.
第四季度,Imfinzi 和 Imjudo 分別實現了 18% 和 28% 的成長,反映了美國肺癌和肝癌治療領域的持續需求以及歐洲透過 HIMALAYA 加速對 TOPAZ 的採用。
As expected, we saw continued impact on established Rest of World revenues following the two mandatory price reductions in Japan that took effect in 2024.
正如預期的那樣,自 2024 年日本實施兩次強制性降價以來,我們看到世界其他地區的現有收入繼續受到影響。
Lynparza achieved global sales of over $3 billion in 2024, triggering receipt of a $600 million milestone payment in the fourth quarter, which was recorded in Collaboration revenue.
2024年,Lynparza 的全球銷售額超過 30 億美元,並在第四季度獲得了 6 億美元的里程碑付款,該款項計入合作收入。
As the established standard of care across HER2-positive and HER2 low metastatic breast cancer, Enhertu delivered total revenue growth of 54% in the fourth quarter, partly offset by stock compensation following recent NRDL listings in China for DESTINY-Breast03 and DESTINY-Breast04.
作為 HER2 陽性和 HER2 低轉移性乳癌的既定標準治療方法,Enhertu 在第四季度實現了 54% 的總收入增長,但 DESTINY-Breast03 和 DESTINY-Breast04 近期在中國國家健保目錄上市後的股票補償部分抵消了這一增長。
Last week, we received FDA approval and NCCN guideline inclusion for DESTINY-Breast06, which will further drive adoption in the ultralow setting.
上週,我們獲得了 FDA 批准和 NCCN 指南對 DESTINY-Breast06 的納入,這將進一步推動超低環境下的採用。
Truqap delivered $163 million in fourth quarter revenues, which partially benefited from stocking following the launch of the blister packs in the US.
Truqap 在第四季營收為 1.63 億美元,部分得益於在美國推出泡罩包裝後的備貨。
And I'm pleased to report, Truqap is now a market leader in the second line biomarker-altered patient population.
我很高興地報告,Truqap 現在是二線生物標記改變患者群體的市場領導者。
We received a number of landmark regulatory approvals since third quarter results, including US and Japan approvals for Datroway, an HR-positive HER2-negative breast cancer; US approval for Calquence in mantle cell lymphoma; Imfinzi and limited stage small cell lung cancer; and European approval for Tagrisso in early-stage unresectable lung cancer.
自第三季業績公佈以來,我們獲得了多項具有里程碑意義的監管批准,包括美國和日本批准的 HR 陽性 HER2 陰性乳癌藥物 Datroway;美國批准 Calquence 治療套細胞淋巴瘤; Imfinzi 和有限期小細胞肺癌;以及歐洲批准 Tagrisso 用於治療早期不可切除的肺癌。
And finally, we received priority review designations for Datroway and late-line EGFR-positive lung cancer based on the TROPION-Lung05 study and Imfinzi and muscle invasive bladder cancer, signaling the potential value of our rapidly advancing oncology pipeline.
最後,我們根據 TROPION-Lung05 研究獲得了 Datroway 和晚期 EGFR 陽性肺癌以及 Imfinzi 和肌肉層浸潤性膀胱癌的優先審查資格,這表明我們快速推進的腫瘤學管道具有潛在價值。
Next slide, please.
請看下一張投影片。
So coming off this remarkable year of growth, we see continued momentum for our oncology medicines in 2025, particularly Tagrisso, Enhertu and Imfinzi despite the incremental impact from Part D redesign and the anticipated inclusion of Lynparza in [VBP] Batch 11 in China.
因此,在這非凡的增長之年之後,我們預計我們的腫瘤藥物在 2025 年將繼續保持增長勢頭,尤其是 Tagrisso、Enhertu 和 Imfinzi,儘管 D 部分重新設計以及 Lynparza 預計將被納入中國 [VBP] 第 11 批產生了增量影響。
Tagrisso is positioned to remain the market leader in frontline EGFR-mutated non-small cell lung cancer, and we expect continued expansion of ADAURA and LAURA in early-stage disease in the year ahead.
Tagrisso 將繼續保持其在 EGFR 突變非小細胞肺癌一線治療領域的市場領先地位,我們預計 ADAURA 和 LAURA 將在未來一年繼續在早期疾病領域推廣。
Longer-term combination trials are designed to reinforce Tagrisso as the backbone TKI, addressing late-line MET-driven disease resistance with SAFFRON and SAVANNAH and investigating novel ADC combinations with TROPION-Lung14 and 15.
長期聯合試驗旨在強化 Tagrisso 作為骨幹 TKI 的作用,透過 SAFFRON 和 SAVANNAH 解決晚期 MET 驅動的疾病抗藥性,並研究與 TROPION-Lung14 和 15 的新型 ADC 組合。
For Enhertu, we anticipate new international launches for HER2-positive and HER2 low breast cancer as well as further expansion from DESTINY-Breast06 to drive growth over the course of this year.
對於 Enhertu,我們預計 HER2 陽性和 HER2 低乳癌新藥將在國際上推出,DESTINY-Breast06 也將進一步擴展,以推動今年的成長。
Moreover, the HER2-positive breast cancer trials reading out this year represent the next meaningful leg of growth for Enhertu.
此外,今年的 HER2 陽性乳癌試驗結果代表 Enhertu 的下一個有意義的成長階段。
On Imfinzi, following positive Phase 3 readouts in lung and bladder last year, we anticipated ADRIATIC, AEGEAN, and NIAGARA launches to initiate the next wave of Imfinzi growth, bolstered by continued adoption of HIMALAYA in liver cancer.
對於 Imfinzi 而言,繼去年肺癌和膀胱癌治療的 3 期臨床試驗取得積極進展後,我們預計 ADRIATIC、AEGEAN 和 NIAGARA 的推出將開啟 Imfinzi 的下一波增長,而 HIMALAYA 在肝癌治療領域的持續應用也將推動這一趨勢。
And beyond '25, we expect bladder and GI to unlock further expansion for Imfinzi and Imjudo.
並且,在 25 年後,我們預計膀胱和胃腸道疾病將為 Imfinzi 和 Imjudo 帶來進一步的擴展。
We expect Calquence to remain the leading BTK inhibitor in frontline CLL, supported by accelerating volume over the balance of the year.
我們預計,Calquence 將繼續成為一線 CLL 領域領先的 BTK 抑制劑,並受益於全年剩餘時間銷售的加速成長。
However, we do anticipate gross to net pressure both from Part D redesign and where we've taken contracting decisions to secure preferred formulary access in the United States.
然而,我們確實預計,無論是由於 D 部分的重新設計,還是為了確保在美國獲得優先處方權而做出的簽約決定,都會帶來總壓力到淨壓力。
We expect meaningful demand growth upon the approval of AMPLIFY, which will allow us to grow into the finite therapy segment, which represents nearly half of the CLL frontline market today.
我們預計,AMPLIFY 獲批後需求將大幅成長,這將使我們發展到有限治療領域,目前佔 CLL 一線市場的近一半。
And finally, for Truqap, our most recent launched medicine, we see continued market leadership in the core second-line biomarker altered population.
最後,對於我們最近推出的藥物 Truqap,我們看到其在核心二線生物標記改變人群中繼續保持市場領先地位。
We're set to deliver another year of strong growth, which is supported by continued global demand for our medicines as well as meaningful indication expansion opportunities.
我們預計將實現另一年的強勁成長,這得益於全球對我們藥品的持續需求以及有意義的適應症擴展機會。
And with that, please advance to the next slide, and I will hand it over to Susan to cover R&D.
接下來,請進入下一張投影片,我將把它交給 Susan 負責研發工作。
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Thank you, Dave.
謝謝你,戴夫。
So 2025 is shaping up to be a very exciting year for our Oncology pipeline.
因此,2025 年對於我們的腫瘤學管道來說將是非常令人興奮的一年。
We look to maximize the reach of our innovative medicines across lung, breast, GI and bladder cancers and present additional data for some of our transformative technologies, including our IO bispecifics, ADCs and T-cell engagers.
我們希望最大限度地擴大我們的創新藥物在肺癌、乳腺癌、胃腸道和膀胱癌領域的覆蓋面,並為我們的一些變革性技術提供更多數據,包括我們的 IO 雙特異性抗體、ADC 和 T 細胞接合劑。
In the second half of 2025, we plan to announce the high-level results from the Phase 3 AVANZAR study of Datroway in combination with Imfinzi and platinum chemotherapy in patients with first-line non-small cell lung cancer.
2025年下半年,我們計劃公佈Datroway聯合Imfinzi和鉑類化療治療一線非小細胞肺癌患者的3期AVANZAR研究的高水準結果。
AVANZAR will be the first of five Phase 3 trials in frontline non-small cell lung cancer to read out and has potential to not only confirm combination efficacy with IO but also1 serve as the first prospective validation of the TROP2 QCS NMR biomarker.
AVANZAR 將成為一線非小細胞肺癌五項 3 期試驗中第一個被宣讀結果的試驗,它不僅有可能確認與 IO 的聯合療效,而且還可作為 TROP2 QCS NMR 生物標誌物的首次前瞻性驗證。
Importantly, we recently amended the primary endpoint to focus on the non-squamous population and to look at the benefit in both TROP2-positive on squamous and the broader non-squamous population, which we believe increases the probability of the trial's success.
重要的是,我們最近修改了主要終點,將重點放在非鱗狀細胞人群上,並研究 TROP2 陽性對鱗狀細胞和更廣泛的非鱗狀細胞人群的益處,我們相信這增加了試驗成功的可能性。
Additionally, we expect results from the TROP2 Breast02 trial of Datroway in triple-negative breast cancer in the first half of this year.
此外,我們預計 Datroway 在三陰性乳癌治療中的 TROP2 Breast02 試驗的結果將在今年上半年公佈。
In 2025, Enhertu will move into earlier lines of treatment for HER2-positive breast cancer.
2025 年,Enhertu 將進入 HER2 陽性乳癌的早期治療領域。
DESTINY-Breast09 aims to bring Enhertu to the first-line metastatic setting with both monotherapy and pertuzumab combination options.
DESTINY-Breast09 旨在將 Enhertu 帶入一線轉移性治療領域,提供單一療法和帕妥珠單抗聯合治療選擇。
DESTINY-Breast05 and 11 are the first two readouts were in HER2 in the early breast cancer setting, where the opportunity for cure is even higher.
DESTINY-Breast05 和 11 是早期乳癌中 HER2 的前兩個讀數,治癒的機會更高。
(inaudible) bladder and gastric programs continue to advance with readouts for VOLGA, which builds on NIAGARA, the combination of infortinib/vadotin and Imfinzi plus minus Imjudo in patients with muscle invasive bladder cancer with POTOMAC in non-muscle invasive bladder cancer and with MATTERHORN in gastric cancer.
(聽不清楚) 膀胱和胃部計畫繼續推進,VOLGA 的讀數以 NIAGARA 為基礎,該方案將 infortinib/vadotin 和 Imfinzi 加減 Imjudo 組合用於治療肌層浸潤性膀胱癌患者,將 POTOMAC 用於治療非肌層浸潤性膀胱癌,將 MATTERHORN 用於治療胃癌。
Together, these trials represent meaningful new opportunities for Datroway, Enhertu and Imfinzi as we look to expand the reach of these transformative medicines.
總之,這些試驗為 Datroway、Enhertu 和 Imfinzi 帶來了有意義的新機遇,我們希望擴大這些變革性藥物的覆蓋範圍。
This year, we'll also report Phase 3 results from a very promising NME in our pipeline, camizestrant, which has potential to be the best-in-class next-generation oral service.
今年,我們還將報告我們研發過程中一個非常有前景的 NME——camizestrant 的第三階段結果,它有可能成為一流的下一代口腔服務。
As a complete estrogen receptor antagonist, camizestrant not only binds to the receptor inhibiting transcriptional activity, but it also induces degradation of the receptor itself.
作為一種完全的雌激素受體拮抗劑,卡米司群不僅與受體結合抑制轉錄活性,而且還誘導受體本身的降解。
In contrast, aromatase inhibitors only reduced production of the ligand estrogen, reducing ligand driven transcription activity but leaving the estrogen receptor in place.
相反,芳香化酶抑制劑僅減少配體雌激素的產生,降低配體驅動的轉錄活性,但仍保留雌激素受體。
This dual action of camizestrant gives us confidence that it can provide greater benefit to patients than aromatase inhibitors regardless of ESR1 mutation status.
卡米司群的這種雙重作用讓我們相信,無論 ESR1 突變狀態如何,它都能為患者帶來比芳香化酶抑制劑更大的益處。
Our confidence is supported by the Phase 2 SERENA-3 trial, where we saw a similar median progression-free survival of six to eight months with camizestrant regardless of the ESR1 status and a benefit over fulvestrant in head-to-head data with a hazard ratio of 0.58 in the ITT population and 0.33 in the ESR1 mutant population.
第二階段 SERENA-3 試驗支持了我們的信心,在該試驗中我們發現,無論 ESR1 狀態如何,使用卡米司群治療均有相似的 6 至 8 個月的中位無進展生存期,並且頭對頭數據表明卡米司群優於氟維司群,在 ITT 人群中的風險比為 0.58,在 E0.58 人群中的風險比為 0.58,在 ESR3 為 0.58。
These data, taken together with the low discontinuation rates, low rates of GI toxicities, which can be bothersome to patients and the ability to combine all three major CDK4/6 inhibitors, these together drive our confidence across the SERENA and CAMBRIA studies.
這些數據,加上低停藥率、低胃腸道毒性發生率(對患者來說可能很困擾)以及結合所有三種主要 CDK4/6 抑制劑的能力,共同增強了我們對 SERENA 和 CAMBRIA 研究的信心。
SERENA-6 is a free trial to readout and investigate switching the endocrine partner of any CDK4/6 inhibitor from an aromatase inhibitor to camizestrant on emergence of an ESR1 mutation during first-line treatment.
SERENA-6 是一項免費試驗,用於讀取和研究在一線治療期間出現 ESR1 突變時將任何 CDK4/6 抑製劑的內分泌伴侶從芳香酶抑製劑轉換為卡米司群。
The goal of SERENA-6 is to extend the duration of benefit in first line.
SERENA-6 的目標是延長第一線治療的效益持續時間。
ESR1 mutations are treatment acquired with low prevalence at the time of metastatic diagnosis around [5%], increasing to around 40% of the time of disease progression at the end of first-line treatment.
ESR1 突變是透過治療獲得的,在轉移性診斷時的盛行率較低,約為 [5%],而在一線治療結束時,疾病進展時的盛行率上升到 40% 左右。
SERENA-6 addresses the pool of patients currently on first-line aromatase inhibitor plus CDK4/6 inhibitor treatment who have these emerging ESR1 mutations without disease progression on clinical scan.
SERENA-6 針對的是目前正在接受一線芳香化酶抑制劑加 CDK4/6 抑制劑治療的患者,這些患者出現這些新出現的 ESR1 突變,但在臨床掃描中病情沒有進展。
And we estimate this to be around 30% of all endocrine-sensitive first-line patients.
我們估計這佔所有內分泌敏感第一線患者的 30% 左右。
Whilst SERENA-6 focuses on these first-line patients that have emergence of ESR1 mutations, SERENA-4 targets a broader first-line population, those patients with newly diagnosed hormone-receptor-positive endocrine-sensitive metastatic breast cancer, and investigate upfront combination of camizestrant and palbociclib.
SERENA-6 專注於出現 ESR1 突變的第一線患者,而 SERENA-4 則針對更廣泛的一線人群,即新診斷的激素受體陽性內分泌敏感性轉移性乳腺癌患者,並研究卡米司群和哌柏西利的早期組合。
Similarly, we have two ongoing adjuvant trials, CAMBRIA-1, which looks as a switch strategy to extend treatment after two to five years of endocrine therapy with or without a CDK 4/6 inhibitor; and CAMBRIA-2, which investigates the upfront combination of camizestrant with or without abemaciclib.
同樣,我們有兩項正在進行的輔助試驗,CAMBRIA-1,其研究作為一種轉換策略,在兩到五年的內分泌治療後延長治療,無論是否使用 CDK 4/6 抑制劑;以及 CAMBRIA-2,研究 camizestrant 與或不與 abemaciclib 的早期組合。
We look forward to updating you on our camizestrant clinical program, which is designed to support our ambition to establish this new endocrine therapy as a backbone in hormone receptor positive HER2-negative breast cancer.
我們期待向您通報我們的卡米司特臨床計劃的最新進展,該計劃旨在支持我們將這種新的內分泌療法確立為激素受體陽性 HER2 陰性乳腺癌治療的支柱的雄心。
Finally, we continue to progress our transformative technologies into Phase 3.
最後,我們繼續推動我們的變革技術進入第三階段。
We now have nine ongoing Phase 3 for our IO bispecifics and plan to share early data for combinations of rilvegostomig with Datroway and Enhertu later this year.
目前,我們正在進行 9 個 IO 雙特異性抗體的 3 期臨床試驗,並計劃在今年稍後分享 rilvegostomig 與 Datroway 和 Enhertu 聯合治療的早期數據。
Last year, we progressed AZD0901, our claudin 18.2 ADC into Phase 3.
去年,我們的 claudin 18.2 ADC AZD0901 進展到了第 3 階段。
And this year, we plan to advance our B7-H4 targeted ADC with our proprietary linker topo 1 payload, puxitatug samrotecan, otherwise known as PSAM, if you find puxitatug difficult to pronounce -- into a Phase 3 trial in endometrial cancer.
今年,我們計劃將我們的 B7-H4 靶向 ADC 與我們的專有連接體拓撲異構酶 1 有效載荷 puxitatug samrotecan(也稱為 PSAM,如果您覺得 puxitatug 難以發音)推進到子宮內膜癌的 3 期試驗。
In addition, we recently initiated the (inaudible) F1 trial, our first Phase 3 trial for the CD19/CD3 T-cell engager, ASD-0486, in follicular lymphoma.
此外,我們最近啟動了(聽不清楚)F1 試驗,這是我們針對濾泡性淋巴瘤的 CD19/CD3 T 細胞接合劑 ASD-0486 進行的首個 3 期試驗。
These transformative technologies help support delivery of sustained growth beyond 2030.
這些變革性技術有助於支持2030年後的持續成長。
And with that, please advance to the next slide, and I'll pass over to Ruud to cover BioPharmaceuticals performance.
接下來,請進入下一張投影片,我將把發言權交給 Ruud,讓他介紹生物製藥公司的表現。
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Thank you so much, Susan.
非常感謝,蘇珊。
Our BioPharmaceuticals medicine saw another very strong year of performance in 2024 with total revenue growing 21% to $21.9 billion.
我們的生物製藥產品在 2024 年又取得了非常強勁的業績,總收入成長 21% 至 219 億美元。
In the fourth quarter, BioPharmaceuticals growth was 24%.
第四季度,生物製藥成長24%。
R&I grew by 28%, an impressive performance despite softer demand in China due to the mild start to the winter season for respiratory viruses.
R&I 成長了 28%,儘管由於冬季呼吸道病毒疫情開始溫和,導致中國需求疲軟,但這一表現仍然令人印象深刻。
CVRM grew 17% with strong Farxiga growth of 22%, which was partly offset by year-end hospital budget dynamics in China.
CVRM 成長了 17%,其中 Farxiga 成長了 22%,但這部分被中國年終醫院預算的動態所抵消。
Alongside Fasenra and Symbicort, Tezpire became the third blockbuster medicine in our respiratory portfolio with over $1 billion in combined global market sales.
繼 Fasenra 和 Symbicort 之後,Tezpire 成為我們呼吸系統藥物組合中的第三大重磅藥物,全球市場總銷售額超過 10 億美元。
Soon, we can expect to see a fourth blockbuster on that list as Breztri delivers over $0.25 billion in revenue in the fourth quarter.
很快,我們就可以期待看到這份名單上的第四部重磅作品,因為 Breztri 在第四季度實現了超過 2.5 億美元的收入。
Given strong global demand and increased production capacity for Beyfortus, we recorded a sales-related milestone payment of $111 million in the fourth quarter.
鑑於全球需求強勁及 Beyfortus 生產能力的提高,我們在第四季度記錄了 1.11 億美元的銷售相關里程碑付款。
The launch of Wainua in ATTR polyneuropathy is progressing very well.
Wainua 在 ATTR 多發性神經病變治療的應用進展順利。
And we are excited about the longer-term opportunity in the broader ATTR cardiomyopathy
我們對更廣泛的 ATTR 心肌病變的長期機會感到興奮
[indication].
【指徵】。
And following the commercial launch of our Airsupra early last year, we have seen impressive volume growth, and we continue to work on broadening the access for patients.
自去年年初我們的 Airsupra 商業化推出以來,我們的銷售量取得了令人矚目的成長,我們將繼續致力於擴大病患的用藥管道。
Next slide, please.
請看下一張投影片。
We look forward to another year of strong performance in 2025 despite the anticipated Brilinta loss of exclusivity and the potential VBP inclusion for Farxiga and roxadustat.
儘管預計 Brilinta 會失去獨佔權,且 Farxiga 和 roxadustat 可能會被納入 VBP,但我們仍期待 2025 年再次取得強勁表現。
Outside of China, we expect to see further growth of Farxiga due to the continued market leadership in the fast-growing SGLT2 class and see potential for increased adoption with numerous of patients still not receiving guideline directives.
在中國以外,由於 Farxiga 在快速增長的 SGLT2 類藥物中繼續保持市場領先地位,我們預計該藥物將進一步增長,並且由於眾多患者仍未收到指南指示,該藥物的採用潛力將有所增加。
Lokelma surpassed $0.5 billion in total revenue last year, and there's a growth showing that Lokelma can help CKD and heart failure patients with hyperkalemia while maintaining guideline-directed therapy.
去年,Lokelma 的總收入超過了 5 億美元,而且有成長跡象表明,Lokelma 可以幫助患有高鉀血症的 CKD 和心臟衰竭患者,同時保持指南指導治療。
We expect continued growth with further adoption and longer duration of treatment due to demonstrated real-world clinical benefits.
由於已證明的現實世界臨床效益,我們預計隨著進一步採用和治療時間延長,該領域將繼續增長。
Breztri has grown rapidly in the last two years and has gained over two-thirds of the market in China as COPD is a leading cause of death.
由於 COPD 是主要死亡原因,Breztri 在過去兩年中發展迅速,並佔據中國三分之二以上的市場份額。
We anticipate continued growth in China, following the recent addition of COPD to the country's national public health program.
隨著中國最近將慢性阻塞性肺病 (COPD) 納入國家公共衛生計劃,我們預計該疾病在中國將繼續增長。
Our biological respiratory medicines have a strong competitive position in the growing market.
我們的生物呼吸藥物在不斷增長的市場中具有強大的競爭地位。
Biological penetration in asthma remains relatively low with potential for sustained long-term growth.
氣喘的生物滲透率仍相對較低,且具有長期持續成長的潛力。
And the COPD biological market is still immature.
且COPD生物藥物市場還不成熟。
In 2025, we anticipate continued growth from our biologic portfolio in asthma, and we're looking forward to the upcoming RESOLUTE Phase 3 readout for Fasenra in COPD.
2025 年,我們預期氣喘領域的生物製劑產品組合將持續成長,我們也期待即將進行的 Fasenra 在 COPD 領域的 RESOLUTE 第 3 階段試驗的讀數。
Finally, Saphnelo has steadily gained share among systemic lupus erotermatolysis patients treated with intravenous infusions and remains the leading IV biologic in several markets.
最後,Saphnelo 在接受靜脈輸液治療的系統性紅斑狼瘡性功能減退症患者中的份額穩步增長,並且仍然是多個市場領先的靜脈生物製劑。
Subcutaneous biologics represent more of the market for (inaudible) today.
目前,皮下生物製劑佔了(聽不清楚)市場的很大份額。
The ongoing TULIP SC trial is studying a subcutaneous formulation of Saphnelo and has the potential to open a new market opportunity.
正在進行的 TULIP SC 試驗正在研究 Saphnelo 的皮下製劑,並有可能開闢新的市場機會。
Our BioPharmaceuticals portfolio is posed for continued growth in 2025.
我們的生物製藥產品組合預計將在 2025 年繼續成長。
And I will now hand over to Sharon to discuss the latest developments from the BioPharmaceuticals pipeline.
現在我將把時間交給 Sharon,討論生物製藥管道的最新進展。
Next slide, please.
請看下一張投影片。
Sharon Barr - Executive Vice President - BioPharmaceuticals R&D
Sharon Barr - Executive Vice President - BioPharmaceuticals R&D
Thanks, Ruud.
謝謝,魯德。
So 2024 was an exciting year in Biopharma.
因此,2024 年對於生物製藥產業來說是令人興奮的一年。
And in 2025, the momentum continues as we rapidly advance both indication expansion and NME pipeline opportunities.
到 2025 年,隨著我們快速推進適應症擴展和 NME 通路機會,這一勢頭將繼續保持。
In respiratory and immunology, we are building an industry-leading portfolio in asthma and COPD with the opportunity to expand our presence in these diseases, where high unmet medical need remains, with key indication expansion opportunities this year as well as NMEs in late-stage development.
在呼吸和免疫學領域,我們正在建立行業領先的氣喘和慢性阻塞性肺病產品組合,並有機會擴大我們在這些疾病領域的影響力,這些疾病仍然存在很大的未滿足的醫療需求,今年我們將有關鍵的適應症擴展機會以及處於後期開發的 NME。
Starting with Breztri, our triple combination inhaler, already approved in COPD.
從 Breztri 開始,我們的三重組合吸入器已經獲準用於治療 COPD。
We have the opportunity to improve care for people suffering from uncontrolled asthma with a new treatment option.
我們有機會透過新的治療方案來改善對患有無法控制的氣喘患者的照護。
In the Phase 3 KALOS and LOGOS trials, Breztri has the potential to demonstrate asthma control by improved lung function versus current dual combination ICS/LABA treatment, and we look forward to these data readouts in the first half of this year.
在第 3 階段 KALOS 和 LOGOS 試驗中,與目前的雙重組合 ICS/LABA 治療相比,Breztri 有可能透過改善肺功能來證明氣喘控制效果,我們期待在今年上半年看到這些數據。
Fasenra, our IL-5 monoclonal antibody represents another meaningful opportunity to expand our reach beyond severe eosinophilic asthma and EGPA into COPD with the Phase 3 RESOLUTE trial.
Fasenra 是我們的 IL-5 單株抗體,透過 3 期 RESOLUTE 試驗,我們可以將治療範圍從嚴重嗜酸性氣喘和 EGPA 擴展到 COPD,這是另一個有意義的機會。
Characterized by airway blockage and long-term respiratory symptoms, COPD remains the third leading cause of death globally.
慢性阻塞性肺病 (COPD) 的特徵是氣道阻塞和長期呼吸道症狀,仍然是全球第三大死因。
Many patients are not well managed and remain at risk of exacerbations that increase the risk of hospitalization and mortality.
許多患者未得到良好的管理,仍然面臨病情惡化的風險,增加了住院和死亡的風險。
With our strong foundation in biologics, we are seeking to address a broad spectrum of this highly complex and heterogeneous disease through differentiated mechanisms of action to address the underlying inflammatory pathways that may trigger COPD.
憑藉我們在生物製劑方面的堅實基礎,我們正在尋求透過差異化的作用機制來治療這種高度複雜和異質性的疾病,以解決可能引發 COPD 的潛在發炎途徑。
As a key contributor to inflammation, eosinophils are potent effector cells that are believed to play a role in COPD.
嗜酸性粒細胞是發炎的主要誘因,是強大的效應細胞,被認為在 COPD 中發揮作用。
The Phase 3 RESOLUTE trial for Fasenra addresses a population with eosinophilic COPD with baseline blood eosinophils of 300 or above, which represents about 30% of the market.
Fasenra 的 III 期 RESOLUTE 試驗針對的是基線血液嗜酸性粒細胞數為 300 或以上的嗜酸性 COPD 患者,該族群約佔市場的 30%。
To further broaden our reach in COPD, we look forward to initiating a Phase 3 Tezpire trial later this year in patients with eosinophils greater than 150.
為了進一步擴大我們在 COPD 領域的覆蓋範圍,我們期待在今年稍後針對嗜酸性粒細胞大於 150 的患者啟動 3 期 Tezpire 試驗。
And lastly, with our IL-33 monoclonal antibody, tozorakimab, we look forward to the results from our Phase 3 LUNA program next year, which is targeting a COPD population irrespective of eosinophil levels and smoking status.
最後,憑藉我們的 IL-33 單株抗體 tozorakimab,我們期待明年第三階段 LUNA 計劃的結果,該計劃針對的是 COPD 人群,無論嗜酸性粒細胞水平和吸煙狀況如何。
Tozorakimab received FDA Fast Track Designation at the end of 2024, emphasizing the high unmet medical need for this disease.
Tozorakimab 於 2024 年底獲得 FDA 快速通道認證,凸顯了疾病的巨大未滿足醫療需求。
With a robust pipeline of differentiated mechanisms, we have an opportunity to transform outcomes in COPD.
透過強大的差異化機制管道,我們有機會改變 COPD 的治療結果。
Now, turning your focus to the right-hand side of the slide.
現在,將焦點轉向投影片的右側。
In CVRM, we eagerly await the first Phase 3 data from baxdrostat, our novel aldosterone synthase inhibitor.
在 CVRM,我們熱切期待我們的新型醛固酮合成酶抑制劑 baxdrostat 的第一階段 3 期數據。
Both the monotherapy and in combination with dapagliflozin, baxdrostat represents a multi-blockbuster opportunity across areas where patients urgently need new options.
無論是單一療法還是與達格列淨聯合使用,巴曲司他都代表著在患者迫切需要新選擇的領域中具有多重轟動性的機會。
In the second half of this year, we will see data from the Phase 3 BaxHTN trial, assessing baxdrostat as a monotherapy in uncontrolled or resistant hypertension.
今年下半年,我們將看到第 3 階段 BaxHTN 試驗的數據,該試驗評估了 baxdrostat 作為單一療法治療無法控製或難治性高血壓的效果。
We have already seen encouraging blood pressure reduction in Phase 2.
我們已經看到第二階段令人鼓舞的血壓下降。
The PK profile supports 24-hour systolic blood pressure control, which we are looking to confirm in the Bax24 trial also reading out in the second half of 2025.
PK 曲線支援 24 小時收縮壓控制,我們希望在 2025 年下半年的 Bax24 試驗中確認這一點。
The Phase 3 combination trial of baxdrostat with dapagliflozin, BaxDuo-ARCTIC, for those living with kidney disease and high blood pressure was also initiated this past year.
針對患有腎臟疾病和高血壓的患者,巴曲司他與達格列淨的 3 期聯合試驗 BaxDuo-ARCTIC 也於去年啟動。
This reinforces our unique ability for multi-mechanism combinations to address interrelated diseases across our CVRM portfolio.
這增強了我們透過多機制組合來治療整個 CVRM 產品組合中相互關聯的疾病的獨特能力。
Lastly, as we continue to build the next wave of transformative medines in CVRM, I am excited to share that we have recently completed the Phase 2b PURSUIT trial for AZD0780, our oral PCSK9 inhibitor, and we look forward to sharing a data at the American College of Cardiology Annual Meeting next month.
最後,隨著我們繼續在 CVRM 中打造下一波變革性藥物,我很高興地分享我們最近完成了口服 PCSK9 抑制劑 AZD0780 的 2b 期 PURSUIT 試驗,我們期待著下個月在美國心臟病學會年會上分享數據。
With that, please move to the next slide, and I will hand over to Marc to cover our Rare Disease portfolio.
接下來,請翻到下一張投影片,我將把時間交給馬克來介紹我們的罕見疾病產品組合。
Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca
Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca
Thank you, Sharon, and next slide, please.
謝謝你,莎倫,請看下一張投影片。
The Rare Disease delivered total revenue of $8.8 billion in 2024, up 16% year over year, driven by an increased patient demand and launches in new markets.
2024 年,罕見疾病總收入達到 88 億美元,年增 16%,這得益於患者需求的增加和新市場的推出。
Total revenue growth included a 2% benefit from a sales milestone for Koselugo received in the fourth quarter.
總營收成長包括 Koselugo 第四季取得的銷售里程碑帶來的 2% 收益。
In the quarter, Ultomiris grew 33% with the vast majority of growth coming from generalized myasthenia gravis patients who are naive to branded treatments.
本季度,Ultomiris 成長了 33%,絕大部分成長來自未接受過品牌治療的全身性重症肌無力患者。
Outside of emerging market, Soliris revenue continued to decline due to the successful Ultomiris, some competition and, in Europe, biosimilar pressure.
在新興市場之外,由於 Ultomiris 的成功、一些競爭以及歐洲的生物相似藥壓力,Soliris 的收入持續下降。
As a reminder, we expect biosimilars to enter the US market in March of this year.
提醒一下,我們預計生物相似藥將於今年 3 月進入美國市場。
Beyond the complement, Strensiq and Koselugo grew 37% and 97% respectively, driven by continued patient demand, new launches and a favorable tender or the timing in emerging markets. 2024 was another year of double-digit growth for Rare Disease medicine, and we see momentum continuing in 2025.
除此之外,受患者持續需求、新產品上市以及有利的招標或新興市場時機的推動,Strensiq 和 Koselugo 分別增長了 37% 和 97%。 2024 年將是罕見疾病藥物再次實現兩位數成長的一年,我們預計這一勢頭將在 2025 年繼續延續。
Can I advance to the next slide?
我可以前進到下一張幻燈片嗎?
Ultomiris continue to grow, driven primarily by neurology indications, including patients who are new to branded medicines and Soliris switch patients as well as further market expansion.
Ultomiris 繼續成長,主要受神經學適應症的推動,包括首次使用品牌藥物的患者和 Soliris 轉換患者以及進一步的市場擴張。
We indicated peak year sales for Ultomiris to be above $5 billion with contribution from both existing and new indication opportunities, including HSCT-TMA, CSA-AKI and IgAN.
我們預計 Ultomiris 的高峰年銷售額將超過 50 億美元,這得益於現有和新的適應症機會,包括 HSCT-TMA、CSA-AKI 和 IgAN。
For Strensiq, we anticipate further adoption supported by new hypophosphatasia guidelines, which have led to an increased disease awareness, diagnosis rates and accelerated new patient starts.
對於 Strensiq,我們預計將在新的低磷酸酯酶症指南的支持下進一步採用,這提高了疾病意識、診斷率並加速了新患者的治療。
As we continue to launch Strensiq in new markets globally, we are focused on disease education, which prepare markets ahead of the next-generation efzimfotase alfa launch.
隨著我們繼續在全球新市場推出 Strensiq,我們專注於疾病教育,為下一代 efzimfotase alfa 的推出做好市場準備。
Patient demand and geographic expansion continue to drive Koselugo growth in pediatric patients with NF1-PN.
患者需求和地理擴張繼續推動 Koselugo 在 NF1-PN 兒科患者中的成長。
And following the positive Phase 3 trial results in adult with NF1-PN, we expect KOMET to drive growth beyond 2025.
並且根據針對患有 NF1-PN 的成人患者的 3 期試驗的積極結果,我們預計 KOMET 將在 2025 年後推動成長。
We are well placed to deliver another year of strong growth, supporting by global demand for Rare Disease medicine as well as meaningful indication expansion opportunities.
由於全球對罕見疾病藥物的需求以及有意義的適應症擴展機會,我們已做好準備,實現另一年的強勁成長。
Please advance to the next slide.
請前進到下一張幻燈片。
We anticipate 2025 to be a catalyst-rich year, unlocking the next wave of innovative rare disease medicine.
我們預計 2025 年將是催化劑豐富的一年,開啟下一波創新罕見疾病藥物的浪潮。
We expect five Phase 3 readouts across multiple indications.
我們預計在多重適應症中會有 5 個第 3 階段的讀數。
Following Phase 2 data, we believe enaboparatide, PTH receptor agonist has the potential to normalize serum calcium levels, decrease urinary calcium and preserve bone mineral density, all clinical priorities of hypoparathyroidism.
根據第 2 期的數據,我們相信副甲狀腺功能低下症的臨床重點,即副甲狀腺素受體激動劑埃那巴帕肽具有使血清鈣水平正常化、降低尿液鈣和維持骨礦物質密度的潛力。
Novel depleter, anselamimab, has been developed to remove toxic like amyloid fibrils that accumulate in the heart and kidneys.
新型清除劑安塞拉米單抗已被開發用於清除積聚在心臟和腎臟中的毒素,如澱粉樣蛋白原纖維。
In light chain amyloidosis, this fibril is co-systemic and progressive organ damage, hospitalization and high mortality when accumulated.
在輕鏈澱粉樣變性中,這種原纖維在累積時會導致全身性和進行性器官損傷、住院治療和高死亡率。
Efzimfotase alfa, our next-generation enzyme replacement therapy, is being studied in a broad hypophosphatasia population.
我們的下一代酵素替代療法 Efzimfotase alfa 正在廣泛的低磷酸酯酶症人群中進行研究。
With an improved profile, which allows for lower dosing and lower frequency, it has the potential to address six times the patient population versus Strensiq.
由於其特性得到改善,可以降低劑量和降低用藥頻率,與 Strensiq 相比,它可以治療六倍的患者群體。
Third-generation C5 inhibitor, gefurulimab, VHH that allows for weekly subcutaneous administration has the potential to expand our reach in myasthenia gravis to treat an earlier and broader population.
第三代 C5 抑制劑吉呋新單抗(VHH)允許每週皮下給藥,有可能擴大我們在重症肌無力方面的治療範圍,以更早、更廣泛地治療人群。
And lastly, for Ultomiris in HSCT-TMA, the product has the potential to address life-threatening complication of stem cell transplant and represent the first indication expansion opportunity for Ultomiris beyond the Soliris label.
最後,對於 HSCT-TMA 中的 Ultomiris,該產品有可能解決幹細胞移植的危及生命的併發症,並代表了 Ultomiris 超越 Soliris 標籤的第一個適應症擴展機會。
These trials, combined significant peak revenue potential, marking a meaningful contribution to the Rare Disease portfolio.
這些試驗結合起來具有巨大的峰值收入潛力,為罕見疾病組合做出了有意義的貢獻。
And with this, I will hand over to Pascal.
現在,我將把權力移交給帕斯卡。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you, Marc, and I will try to conclude quickly so we can move to the Q&A session.
謝謝你,馬克,我會盡快結束討論,這樣我們就可以進入問答環節。
Next slide, please.
請看下一張投影片。
So as you can see here, we are making a very important step toward the achievement of our strategic ambitions, in particular, the $80 billion sales in 2030.
所以正如您所看到的,我們正在朝著實現我們的策略目標邁出非常重要的一步,特別是 2030 年 800 億美元的銷售額。
And we are progressing high-value readouts that will unlock further growth.
我們正在進行高價值讀數的開發,這將帶來進一步的成長。
So if we move to the next slide.
因此如果我們轉到下一張投影片。
This is an important slide because it really shows the investments we are making.
這是一張重要的幻燈片,因為它真實地展示了我們正在進行的投資。
And of course, those investments create R&D budget expansion, but those are investments that are not only supporting the growth of our existing (inaudible) portfolio, but we're also building capabilities and capacity with potentially transformative technologies shown here, our goal is to be a growth company until 2030 but also beyond 2030 and anticipate today what will shape the future of medicine and how we will actually continue to grow despite patent expiries that may happen post 2030.
當然,這些投資會擴大研發預算,但這些投資不僅支持我們現有(聽不清楚)產品組合的成長,而且我們還在利用這裡展示的潛在變革性技術進行能力和產能建設,我們的目標是成為一家成長型公司,直到 2030 年,而且要超越 2030 年,並預測什麼將塑造醫學的未來,以及我們將如何繼續增長,儘管 2030 年後可能會發生專利。
And with this, I'm really pleased to report that we're making very good progress in all of these areas, with multiple pivotal trials planned or initiated for our ADCs, our bispecifics and most recently, our CAR-T and our T-cell engager programs.
我很高興地報告,我們在所有這些領域都取得了非常好的進展,我們的 ADC、雙特異性抗體以及最近的 CAR-T 和 T 細胞接合器計劃正在計劃或啟動多個關鍵試驗。
These transformative technologies have the potential to drive sustained growth beyond 2030.
這些變革性技術有可能推動2030年後的持續成長。
Next slide, please.
請看下一張投影片。
We continue to make progress against all the ambitions outlined at our Investor Day in May 2024.
我們將繼續朝著 2024 年 5 月投資者日提出的所有目標邁進。
We set our sights on $80 billion in total revenue by 2030, as we communicated at the Investor Day.
正如我們在投資者日上所說的那樣,我們的目標是到 2030 年實現 800 億美元的總收入。
By the end of this year, early 2026 latest, we'll have a very good idea as to whether this ambition can be achieved.
到今年年底,也就是 2026 年初,我們就會很清楚這個目標是否能夠實現。
We're also working hard to drive operating leverage throughout our company, and we continue to make good progress towards achieving our ambition for mid-30s operating margin in 2026.
我們也努力提高整個公司的營業槓桿率,並持續朝著實現 2026 年營業利潤率達到 30% 左右的目標邁進。
And finally, and most importantly, we have actually delivered eight new medicines toward our goal of 20 by 2030, and that demonstrates our ability as a team to deliver life-changing medicines for patients globally.
最後,最重要的是,我們實際上已經交付了 8 種新藥,而我們的目標是到 2030 年交付 20 種新藥,這證明了我們作為一個團隊為全球患者提供改變生活的藥物的能力。
Please move to the next slide.
請移至下一張投影片。
As Andy mentioned at the start of the call, please limit the number of questions you ask to allow others a fair chance to participate.
正如安迪在通話開始時提到的,請限制您提出的問題數量,以便其他人有公平的參與機會。
I must say this is what I say each time, but I'm never very successful with that one.
我必須說這就是我每次說的話,但我從來沒有成功過。
(Event Instructions)
(活動須知)
And with that, let's move the first question.
那麼,讓我們來討論第一個問題。
Thank you.
謝謝。
Let's start with this table and we go around the table and move to the next table.
我們從這張桌子開始,繞著這張桌子走一圈,然後轉到下一張桌子。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Yes, James, maybe you can start.
是的,詹姆斯,也許你可以開始。
James Gordon - Analyst
James Gordon - Analyst
Thanks for taking the question.
感謝您回答這個問題。
James Gordon from JP Morgan.
摩根大通的詹姆斯戈登。
I'll stick to one theme, which will be China.
我會堅持一個主題,那就是中國。
So a couple of questions on China.
我有幾個關於中國的問題。
So one would be, some revenues down 3% in Q4.
因此,第四季的部分營收將下降 3%。
But how did it evolve during the quarter?
但本季它是如何發展的呢?
So what did it look like before there was the investigation on November 5 versus afterwards?
那麼 11 月 5 日調查之前和之後的情況如何?
And more recently, like the start of this year, are things getting better or worse in China?
那麼最近,例如今年年初,中國的情況是變好了還是變壞了?
Also in China, so for 2025, so you've given us a group guide, but what does that seem for China?
同樣在中國,對於 2025 年,您為我們提供了小組指南,但是對於中國來說,這似乎是什麼?
And I can see we've got Lynparza and probably Farxiga VBP.
我看到我們有 Lynparza 和可能的 Farxiga VBP。
So should we assume that China is going to decline overall, not just because of the investigation but also VBP, but EM overall still grows, how to think about that?
那麼,我們是否應該假設中國整體上會衰退,不僅是因為調查,也因為 VBP,但新興市場整體仍在成長,該如何看待這一點?
And then just finally, on China.
最後,談談中國。
So I think there've been investigations going for some time, but I've not seen any provision for a fine or other penalty in your disclosures.
所以我認為調查已經進行了一段時間了,但我沒有在你們的披露中看到任何關於罰款或其他處罰的規定。
So how should we read that?
那我們該怎麼解讀呢?
Does that mean you don't think there is likelihood that you're going to have to pay something material?
這是否意味著您認為您不太可能需要支付一些實質的費用?
Or is it just you wouldn't provision for it at this time?
還是您只是現在不願意為此做好準備?
When would you have to have a provision for something?
什麼時候你必須為某事做好準備?
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you, James.
謝謝你,詹姆斯。
So let me start with the last question, and then for the business development and business growth, I'll ask Iskra to comment and maybe Aradhana for the guidance question.
所以讓我從最後一個問題開始,然後對於業務發展和業務成長,我會請 Iskra 發表評論,也許請 Aradhana 提出指導性問題。
So we actually disclosed things as we learn about this investigation.
因此,我們在了解這項調查的情況後實際上披露了一些資訊。
An important case is that we disclose anything that we believe will have a potential liability dimension.
一個重要的案例是,我們揭露我們認為可能具有潛在責任層面的任何事物。
We disclosed this in our release.
我們在新聞稿中披露了這一消息。
I would like to refer you to this and look at it.
我想向您推薦這個並看一下。
So if you look at these things in term, first of all, the illegal importation.
所以如果你從各個角度來看這些事情,首先就是非法進口。
We've communicated $0.9 million of avoided import duties.
我們已經避免了90萬美元的進口關稅。
To the best of our ability -- to the best of our knowledge, as we said, it relates to Imfinzi and Imjudo, the fine that could be associated with that, if AstraZeneca is found liable for it, would be 1 to 5 times the amount of avoided import duties, so 5 times -- maximum 5 times the $0.9 million.
據我們所知,正如我們所說,這與 Imfinzi 和 Imjudo 有關,如果阿斯特捷利康被判有罪,那麼與此相關的罰款將是所逃進口關稅金額的 1 到 5 倍,也就是 5 倍——最多是 90 萬美元的 5 倍。
Now, it is possible that Enhertu, for instance, will be affected as well because those products -- the products that are affected -- essentially products that were approved in Hong Kong, not yet approved on the Mainland.
現在,Enhertu 也有可能受到影響,因為受影響的產品基本上是在香港獲得批准、但尚未在內地獲得批准的產品。
And there's a limited period of time during which patients actually can totally legally go to Hong Kong and get their medicines.
但實際上,患者可以在有限的時間內合法前往香港獲取藥品。
But of course, some people found the opportunity here to take this product from Hong Kong and deliver them to the patients on the Mainland, and that is illegal.
但當然,有些人藉此機會將這種產品從香港運送給內地的患者,這是違法的。
Patients can go, get their medicines.
病人可以去取藥。
Other people are not allowed to do the transportation, if you want, of those medicines to patients.
如果你願意的話,其他人不被允許將這些藥品運送給病人。
So we know Enhertu, of course, had a period of time when it was approved in Hong Kong, not on the Mainland.
因此,我們知道 Enhertu 有一段時間是在香港獲得批准的,而不是在內地。
So that could be another one.
所以那可能是另一個。
But again, the turnover associated with Enhertu is a bit bigger than Imfinzi, but It's not going to be massively bigger.
但同樣,Enhertu 的營業額比 Imfinzi 稍大,但不會大很多。
So that's the illegal importation case.
這就是非法進口案件。
And that's basically what we know in terms of the so-called fraud case.
這就是我們對所謂的詐欺案所了解的基本情況。
Again, I just like to remind you, we closed in the litigation section anything that could have a liability dimension for the company.
再次,我只是想提醒你,我們在訴訟部分結束了任何可能對公司產生責任影響的事情。
Now, some of you would like to, I'm sure, understand better the sort of individual responsibility, corporate responsibility, legal aspects as it relates to fraud case like this.
現在,我相信你們中的一些人希望更好地理解與此類詐欺案件相關的個人責任、企業責任和法律方面的問題。
My best advice is to suggest that you contact one of the magic so-called firms here in London, make sure you -- to get advice, independent advice from them.
我最好的建議是建議你聯絡倫敦所謂的神奇公司,確保你能從他們那裡獲得建議、獨立的建議。
Make sure you ask a firm that has an affiliate in China, our partner in China that has a license to comment on Chinese laws.
確保你詢問的是一家在中國有分支機構的公司,也就是我們在中國的合作夥伴,他們有執照對中國法律發表評論。
Because global firms are not allowed to comment on Chinese laws.
因為跨國公司不允許對中國法律發表評論。
So if you want a precise, reliable answer, you have to get it from someone who has a license in China.
因此,如果您想要一個準確、可靠的答案,您必須從在中國擁有執照的人那裡獲得。
So ask them and you'll get, I believe, a very clear answer to that question.
所以問他們吧,我相信你會得到一個非常明確的答案。
And that's really the most we can actually talk about this case.
這實際上是我們對此案所能談論的最多內容。
If I go back to your first question, James, the sales at the end of at the end of last year in Q4, I mean, when people -- when hospitals manage their inventory, manage their budgets, they start doing this in November, December.
詹姆斯,如果我回到你的第一個問題,去年第四季末的銷售額,我的意思是,當人們——當醫院管理他們的庫存、管理他們的預算時,他們在 11 月、12 月就開始這樣做了。
So that's what we saw and what typically you see.
這就是我們所看到的以及您通常所看到的。
But the biggest thing is that -- to keep in mind is that the impact was very much our respiratory products.
但最重要的是——要記住的是,影響最大的是我們的呼吸產品。
And into January, we see, I think, a pretty good trend.
到了一月份,我認為我們看到了相當好的趨勢。
But of course, the respiratory products are still affected.
但當然,呼吸產品仍然受到影響。
Iskra, over to you and then maybe, Aradhana.
Iskra,交給你了,然後也許是 Aradhana。
Iskra Reic - Executive Vice President - International
Iskra Reic - Executive Vice President - International
Yes.
是的。
Thanks, Pascal.
謝謝,帕斯卡。
So thanks for the question.
感謝您的提問。
So I think as Pascal mentioned, I mean, there is not much to read in the dynamic of the quarter four because it's really -- you will see the same trend in the respiratory products given the mild winter.
因此,我認為正如帕斯卡所提到的那樣,第四季度的動態沒有太多可解讀的,因為考慮到溫和的冬季,你會看到呼吸產品呈現相同的趨勢。
And it's interesting to look at because it's -- because of the mild winter, clearly you have a lower level of the flu infection that drives lower rate of the hospitalization.
這很有趣,因為由於冬季氣候溫和,流感感染率明顯較低,降低了住院率。
And particularly in China, those products, Pulmicort in particular, are really used the hospitalization and exacerbation.
特別是在中國,這些產品,尤其是普米克令舒,確實用於住院治療和緩解病情加重。
And if you look at the overall inhaler market, you will also see the significant slowdown in growth.
如果你看看整個吸入器市場,你也會看到成長明顯放緩。
Quarter four, growth of the inhaled market was 9% versus 23% in quarter three.
第四季度,吸入式市場成長率為 9%,而第三季為 23%。
So I would argue that's a very clear dynamic that you can see throughout the quarter.
所以我認為這是一個非常明顯的動態,你可以在整個季度看到。
As you know, the winter is back and the flu infections in China are quite up.
大家知道,冬季已經來臨,中國的流感感染率也隨之上升。
So you would argue that you may expect the respiratory portfolio performing as expected as normal in the quarter one.
因此,您可能會認為呼吸產品組合在第一季的表現將如預期般正常。
I think the second mentioned dynamic was the hospital capping.
我認為提到的第二個動態是醫院封頂。
And I think it's -- you see the similar trend, I would argue, the same trend as you saw last for the top 10 brands in the -- listed in the hospitals in China.
我認為,你會看到類似的趨勢,與你上次在中國醫院中列出的前 10 個品牌中看到的趨勢相同。
The only difference is that this year, that effect was a bit bigger because more hospitals were introducing the hospital capping, trying to manage their budgets and the pressure at the end of the year.
唯一的區別是,今年的影響更大一些,因為更多醫院引入了醫院上限,試圖管理預算和年底的壓力。
But overall, it's looking, in 2025, obviously, early days.
但總體而言,2025 年顯然仍處於早期階段。
But you do expect the portfolio to continue to grow.
但你確實預期投資組合將繼續成長。
We have a few good news in the start of the year.
今年年初我們有一些好消息。
We (inaudible) to being included in NRDL with the eight other renewals in an NRDL and regulatory approval of the two new indications for Tagrisso and Lynparza.
我們(聽不清楚)與其他八個續簽藥品一起被納入國家醫療保健目錄,並且 Tagrisso 和 Lynparza 的兩種新適應症獲得監管部門批准。
So despite the headwinds that we expect from the VBP inclusion in Farxiga, Lynparza and roxadustat, we do expect the rest of the portfolio to continue to grow.
因此,儘管我們預計 VBP 納入 Farxiga、Lynparza 和 roxadustat 會帶來阻力,但我們確實預計其餘投資組合將繼續成長。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
The biggest headwind, really, is VBP in 2025.
事實上,最大的阻力是 2025 年的 VBP。
Iskra, maybe you wanted to say a little bit about the team, where they are at.
伊斯克拉,也許你想簡單談談這支球隊以及他們目前的情況。
I think it's important to get a sense for potential momentum into 2025 but also our interactions with the medical community in China.
我認為了解 2025 年的潛在發展勢頭以及與中國醫學界的互動非常重要。
Iskra Reic - Executive Vice President - International
Iskra Reic - Executive Vice President - International
Yes.
是的。
I just spent four, five weeks in Shanghai, and I was really impressed on one side, as I mentioned in my remarks, on the commitment and -- of the team.
我剛剛在上海待了四、五週,正如我在演講中提到的,我對團隊的承諾和奉獻精神印象深刻。
Equally, I was impressed that -- it was unsettling moment in November and December, but I was really impressed how -- with the stability that we introduced in December and the clear focus on what the team needs to do -- both team, in the office and on the ground, are very much focused and keen to continue doing what we do best, and that is delivering our innovative medicines to the patients in China.
同樣,令我印象深刻的是——11 月和 12 月是令人不安的時刻,但真正讓我印象深刻的是——憑藉 12 月引入的穩定性以及對團隊需要做的事情的明確關注——辦公室和實地團隊都非常專注並渴望繼續做我們最擅長的事情,那就是將我們的創新藥物提供給中國的患者。
And I think the message of the company commitment and our belief that our strategy in China is the right one, that we believe in the -- in our ability to deliver for patients, but equally to use a growing innovation in China for China and for global is very much -- landed very well internally as well as externally.
我認為,公司承諾傳達的訊息以及我們堅信我們的中國戰略是正確的,我們相信我們有能力為患者提供服務,但同樣相信我們能夠利用中國日益增長的創新為中國和全球提供服務,這一信息在公司內部和外部都得到了很好的體現。
I think from my external interactions with many different stakeholders there, I think it's also clear that our partners and stakeholders in China are willing and happy that we will continue to invest and partner with them in order to bring innovations together.
我認為,從我與中國許多不同利益相關者的外部互動來看,很明顯,我們在中國的合作夥伴和利益相關者願意並樂意我們繼續投資並與他們合作,以整合創新。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Aradhana, do you want to
Aradhana,你想
--
--
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
Sure.
當然。
So on the guidance, obviously, the China is included in our guidance.
因此,在指導意見中,顯然中國已包含在我們的指導意見中。
We do assume growth from our underlying brands as well as the NRDL inclusions that Iskra talked about.
我們確實預計我們的基礎品牌以及 Iskra 談到的國家醫療保健目錄將實現成長。
But at the same time, there is headwind from VBP, again, three large products obviously being included in VBP this year as well as some disruption from some of the ongoing investigation and team stability and so forth.
但同時,VBP 也面臨阻力,今年 VBP 顯然會納入三款大型產品,而且一些正在進行的調查和團隊穩定等也會帶來一些幹擾。
Luisa Hector - Analyst
Luisa Hector - Analyst
Thank you.
謝謝。
Luisa Hector from Berenberg.
來自貝倫貝格的 Luisa Hector。
I have just one more on China and then some on the outlook.
我再談一點關於中國的問題,然後再談一些關於前景的問題。
So for China, can you then confirm if there have been no notable changes in your market share for key drugs in China?
那麼對於中國來說,您能否確認您在中國主要藥品的市佔率沒有明顯變化?
And then for the outlook, perhaps just to quantify, if you can, the Part D impact for 2025 redesign.
然後對於展望,如果可以的話,也許只是量化 D 部分對 2025 年重新設計的影響。
I think I only heard mention of Calquence from Dave, but perhaps other products to be aware of.
我想我只聽到戴夫提到了 Calquence,但也許還有其他產品值得注意。
And Aradhana, you mentioned $3 billion of deal-related payments.
阿拉達納,您提到了 30 億美元的交易相關付款。
I'm just curious whether you can provide any color on the components.
我只是好奇您是否可以提供任何有關組件的顏色。
And should we assume that the majority of those come essentially with success, so pipeline success, sales success?
我們是否應該認為其中大多數都源自於成功,例如通路成功、銷售成功?
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Sure, I can see that I'm totally failing once more, three questions at a time.
當然,我可以看到我又一次徹底失敗了,一次答了三個問題。
So should we start, Iskra, with you.
那麼,Iskra,我們應該從你開始。
And then Dave, you cover
然後戴夫,你負責
--
--
Iskra Reic - Executive Vice President - International
Iskra Reic - Executive Vice President - International
So quick response on the market share.
對市場佔有率的反應如此之快。
As I mentioned, the initial market is -- I mean, the whole market obviously slowed down.
正如我所提到的,最初的市場——我的意思是,整個市場明顯放緩了。
So clearly, you will not see any major difference in market share.
因此顯然,你不會看到市場份額有任何重大差異。
With Farxiga, you will see some difference, and there is some decline in the end of the year.
使用 Farxiga,你會看到一些差異,而且到年底會出現一些下降。
And the reason is that the hospital capping that I mentioned really applies only for the 10 top performing brands.
原因在於我提到的醫院上限實際上僅適用於表現最好的 10 個品牌。
Clearly, as you know, Farxiga is competing with many different SGLT2 generics in the China market.
顯然,如您所知,Farxiga 正在中國市場上與許多不同的 SGLT2 仿製藥競爭。
So in December, due to the capping, you will see some decline.
因此在 12 月份,由於限制,你會看到一些下降。
We saw the same trend, as I mentioned last year, and you would expect that to bounce back.
正如我去年提到的,我們看到了同樣的趨勢,你會預期這種趨勢會反彈。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
But net-net for important products like Tagrisso, et cetera, so far, we have seen no impact.
但對於 Tagrisso 等重要產品而言,到目前為止,我們還沒有看到任何影響。
Of course, we looked at that because market share is the best way to actually assess whether you're impacted.
當然,我們考慮了這一點,因為市場佔有率是評估您是否受到影響的最佳方式。
And when the market moves up and down, we see no impact at all, yes.
當市場上漲和下跌時,我們根本看不到任何影響,是的。
Early days and so far, we only have hospital data.
早期到目前為止,我們只有醫院數據。
We need a retail data.
我們需要零售數據。
It takes more time to get there.
到達那裡需要更多時間。
But it's very encouraging to see our market share actually not moving differently from what we would expect.
但看到我們的市場份額實際上與我們的預期並無差異,這令人非常鼓舞。
Dave, you'd cover Part D?
戴夫,你會講到 D 部分嗎?
David Fredrickson - Executive Vice President - Oncology Business Unit
David Fredrickson - Executive Vice President - Oncology Business Unit
Yes, please.
是的,請。
So I think the first point we saw on Part D is that the IRA we've continually said we think is manageable; it's part of guidance; it's in our outlook.
因此我認為我們在 D 部分看到的第一點是,我們一直表示認為 IRA 是可管理的;它是指導的一部分;這是我們的觀點。
So it's built in.
因此它是內建的。
So why do we think it's manageable?
那我們為什麼認為它是可控的呢?
Well, first and foremost, it predominantly affects our oral Oncology portfolio.
首先,它主要影響我們的口腔腫瘤學產品組合。
There is some BioPharmaceuticals and Rare Disease impact.
對生物製藥和罕見疾病有一定影響。
But in terms of where we see the greatest impact, it's on oral oncolytics.
但就我們看到的最大影響而言,它是口服溶瘤藥物。
There is a downside pressure on the increase manufacturer liability that now is happening in terms of picking up what was previously catastrophic.
就收拾之前的災難性損失而言,製造商責任的增加現在面臨下行壓力。
But there is a partial offset, and we saw that happening in 2004 from improved adherence and compliance on medicines and also lower free drug utilization.
但有部分抵消,我們看到 2004 年由於藥物依從性和依從性提高以及免費藥物使用率降低而出現的情況。
And that volume is directly a result of improved patient affordability.
而這數量的增加直接得益於患者負擔能力的提升。
And so that's the first dynamic for manageable.
這是第一個可管理的動態。
I think the second thing that's most important here is that we just look at the growth opportunities that we've got in '25, right?
我認為這裡最重要的第二件事是我們只看我們在25年所擁有的成長機會,對嗎?
So Tagrisso, we have continued opportunities, ADAURA, LAURA, FLAURA2; Imfinzi, HIMALAYA, ADRIATIC, CASPIAN, NIAGARA; Enhertu, DV06, DV03; and Truqap.
所以 Tagrisso,我們有繼續的機會,ADAURA、LAURA、FLAURA2;伊姆芬齊、喜馬拉雅、亞得里亞海、里海、尼加拉;恩赫圖,DV06,DV03;和 Truqap。
Those are all in hand.
這些都在手上。
And so it allows us to be able to work through the headwinds that we're getting in from IRA and that's why it's included with
因此,它使我們能夠克服來自 IRA 的阻力,這就是為什麼它被納入
(inaudible).
(聽不清楚)。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Aradhana?
阿拉達那?
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
So just to build on Dave's point, the guidance, especially the gross margin guidance that I provided in terms of 60 to 70 basis points, that does include the net effect of the IRA.
因此,只是為了鞏固戴夫的觀點,指導,特別是我提供的 60 到 70 個基點的毛利率指導,確實包括了 IRA 的淨效應。
Again, we haven't given an absolute quantification, but that, as well as the PPP, as well as some of the impact from biosimilars, that's included in the gross margin indication.
再次重申,我們還沒有給出絕對的量化,但是,這以及 PPP 以及生物相似藥的一些影響都包含在毛利率指標中。
As it relates to the $3 billion for past deal-related payments, yes, most of them are success-based.
至於過去與交易相關的 30 億美元付款,是的,其中大部分都是基於成功的。
But success could not necessarily be Phase 3.
但成功不一定是第三階段。
Some of them have already happened with Daiichi, for example, but it could also be progression events.
例如,其中一些已經發生在 Daiichi 身上,但也可能是進展事件。
So when the product moves into Phase 2 or into Phase 3 so -- which is also success-based, obviously, we want to move them into the next phase if we weren't confident.
因此,當產品進入第 2 階段或第 3 階段時 - 這也是基於成功的,顯然,如果我們沒有信心,我們希望將它們進入下一階段。
So yes, all of those related to -- some of it is Daiichi but also CinCor.
是的,所有這些都與之相關——其中一些是 Daiichi,但也包括 CinCor。
Again, if baxdrostat reads are positive, again, the CD19/CD3, so it's a multitude of smaller payments that are all progression or success-base.
再次,如果 baxdrostat 讀數為陽性,再次,CD19/CD3,那麼這是大量較小的支付,它們都是基於進展或成功。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Just since we talked about Part D, keep in mind that basically, the headwinds we have in 2025 are, of course, IRA, two is VBP China, we mentioned it.
既然我們談到了 D 部分,請記住,基本上,我們在 2025 年面臨的阻力當然是 IRA,其次是 VBP 中國,我們提到這一點。
Another couple of smaller ones, Brilinta patent expiry and the usual maybe more intense this year [cottage] industry of price cuts and rebates and whatever in Europe.
另外還有一些較小的因素,Brilinta 專利到期,以及今年歐洲家庭工坊式的降價和回扣等行為可能更激烈。
But the momentum in the portfolio and in the new indications we hope to launch certainly will continue to support our goals and move through these challenges in '25.
但我們希望推出的投資組合和新跡象的勢頭必將繼續支持我們的目標,並在2025年克服這些挑戰。
There's one last question on the table left.
桌子上還剩下最後一個問題。
Jo Walton - Analyst
Jo Walton - Analyst
Jo Walton from UBS.
瑞銀的喬沃爾頓。
A couple of clarifications, I think.
我認為需要澄清幾點。
Aradhana, I didn't catch what you said about the gross margin impact 2025.
Aradhana,我沒聽清楚你所說的關於 2025 年毛利率影響的內容。
Could you just tell us again what you're expecting to happen there?
您能否再告訴我們一下您預計那裡會發生什麼事情?
You spoke very quickly.
你說話很快。
And is that something that we should continue to see through into '26 as well?
我們是否也應該在 26 年繼續關注這個問題?
Or is it just a one-time impact?
或只是一次性影響?
And just to go back to Part D again, if we can.
如果可以的話,我們就再回到 D 部分。
You say you -- are you already seeing increased adherence.
你說你——你是否已經看到了依從性的提升。
In 2024, the payment levels were lower but they aren't as low as they're going to be in 2025.
2024 年的支付水準較低,但不會像 2025 年那麼低。
So are you anticipating a further improvement in adherence?
那麼,您是否預期依從性會進一步提高?
And is there any chance of things being even better in the first quarter because of the all-you-can-eat buffet that you get -- if you pay your [2,000] across the year rather than have to pay a big lump sum in January?
而且,如果您在全年支付 [2,000] 而不是在一月份支付一大筆錢,那麼由於您可以享受無限量自助餐,第一季的情況是否有可能變得更好?
So just whether we should be seeing anything in the short term.
那麼我們是否應該在短期內看到任何事情。
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
So I'll address the gross margin one.
因此我將討論毛利率問題。
So the indication is more around the -- so I said 60 to 70 basis points impact on gross margins.
所以跡象更多的是——所以我說對毛利率有 60 到 70 個基點的影響。
And a lot of that comes from the [parties] -- the net effect of the quarterly payments.
其中很大一部分來自於各方——季度付款的淨效應。
If you want to think about it, again, it's not a gross to net discount, but it does affect what you pay off of your revenue base, so that's included there.
如果你願意再考慮一下,這不是總折扣到淨折扣,但它確實會影響你從收入基礎中支付的金額,所以這也包括在那裡。
When I say VBP, again, VBP, when you get your price for VBP and their stock compensation and so forth, it affects your price, right?
當我說 VBP 時,再說一次,VBP,當你獲得 VBP 的價格和他們的股票補償等等時,它會影響你的價格,對嗎?
It doesn't affect necessarily your volume.
它不一定會影響您的音量。
There's some impact on volume.
對音量有一定影響。
But you hope that once there's a reset on volume, obviously, generics will take some share, and then you'll start going from there, which is what we've seen in other VBP situations.
但是您希望,一旦數量重置,顯然仿製藥會佔據一些份額,然後您將從那裡開始,這就是我們在其他 VBP 情況下看到的情況。
So again, that impacts your gross margin because your price is basically reset.
所以,這會影響你的毛利率,因為你的價格基本上被重置了。
I talked a little bit about -- and Pascal said a whole bunch of other price actions which you see in Europe and other countries.
我談了一點——帕斯卡還談到了你在歐洲和其他國家看到的一系列其他價格行為。
Soliris biosimilar is another example, right, where we have been transitioning more and more of the market to Ultomiris.
Soliris 生物相似藥就是另一個例子,我們已經將越來越多的市場轉向 Ultomiris。
Again, Ultomiris is at a 30% lower price than Solirisis.
再次,Ultomiris 的價格比 Solirisis 低 30%。
So it's more market shifts to Ultomiris, again, slightly different, slightly lower gross margins than Soliris.
因此,市場更多地轉向了 Ultomiris,同樣,其略有不同,毛利率比 Soliris 略低。
So it's all of those factors that -- and again, I don't think they are one-time factors, but that's sort of what we expect to point to come to.
所以所有這些因素都是——我再說一次,我認為它們不是一次性因素,但這有點像我們期望指出的。
Dave?
戴夫?
David Fredrickson - Executive Vice President - Oncology Business Unit
David Fredrickson - Executive Vice President - Oncology Business Unit
Thanks, Aradhana.
謝謝,Aradhana。
Jo, so yes, in 2024, in the oral Oncology portfolio, we saw both a reduction in free goods as well as an improvement in adherence, or sometimes we talk about that as abandonment rates.
喬,是的,在 2024 年,在口服腫瘤學產品組合中,我們看到免費商品的減少以及依從性的提高,或者有時我們稱之為放棄率。
And that came as a result of the co-pay cap being set at $3,300 last year.
這是因為去年共同支付上限被設定為 3,300 美元。
Now, obviously, we didn't have the liability that we needed to pay for within that.
現在,很明顯,我們沒有需要支付的責任。
So 2024 was a year where the co-pay was capped but there wasn't the 20% liability.
因此,2024 年是共付額有上限的一年,但沒有 20% 的責任。
The payment structure was still as it existed before.
支付結構仍與以前一樣。
And so that's one of the things that changes within 2025.
這是 2025 年將發生變化的事情之一。
But I think that very importantly, we've had this as an opportunity to help our reimbursement teams and our account managers engage with US customers to understand how they can work together to create education around the new opportunities to be able to think about where charitable programs need to be used, where they might not need to be used and to be able to have an understanding for how the benefit design has changed.
但我認為非常重要的是,我們有這個機會幫助我們的報銷團隊和客戶經理與美國客戶接觸,了解他們如何能夠共同努力,圍繞新的機會進行教育,以便能夠思考慈善計劃需要在哪裡使用,在哪裡可能不需要使用,並能夠了解福利設計是如何變化的。
And I think that there's education around that.
我認為這方面是有教育意義的。
That's one of the things that's resulting in patients being able to be on medicines that are not through charitable foundations.
這是導致患者能夠使用非透過慈善基金會提供的藥物的原因之一。
And then the charitable foundations are able to have more money available to them because of the co-pay caps to be able to serve more patients.
然後,慈善基金會就可以因為共同支付上限而擁有更多的資金,從而能夠為更多的患者提供服務。
So it has really been, I think, in many respects, a real improvement in terms of affordability, resulting in higher volume on the medicines.
因此,我認為,從很多方面來說,這確實在可負擔性方面有了真正的改善,從而提高了藥品銷售。
And I do expect that we'll see that continue into this year, probably not to the same degree of the bump that we saw when we went from uncapped to $3,300 and now $3,300 to $2,000.
我確實預計,這種情況將持續到今年,但可能不會達到我們從無上限到 3,300 美元,再從 3,300 美元到 2,000 美元時那樣的漲幅。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Can we move to another table?
我們可以換到另一張桌子嗎?
Jo Walton - Analyst
Jo Walton - Analyst
Dave, you want to mention the secondary effects, is there -- we're seeing in the commercial.
戴夫,你想提一下我們在廣告中看到的次要影響嗎?
David Fredrickson - Executive Vice President - Oncology Business Unit
David Fredrickson - Executive Vice President - Oncology Business Unit
No, we're not seeing secondary effects into the commercial set.
不,我們沒有看到商業版中的副作用。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Sachin, we move to this table, and we'll get to this table and move there.
薩欽,我們移到這張桌子,然後我們移到這張桌子那裡。
Sachin Jain - Analyst
Sachin Jain - Analyst
Sachin Jain, Bank of America.
美國銀行的 Sachin Jain。
Given it's a pipeline -- two pipeline questions on the two assets you called out.
鑑於它是一條管道——關於您提到的兩項資產的兩個管道問題。
So the first one, I guess is (inaudible) on bax.
所以我猜第一個是在 bax 上(聽不清楚)。
Of the greater the $5 billion peak, how much is in the resistant hypertension opportunity we're getting this year?
在 50 億美元的高峰中,我們今年獲得的難治性高血壓機會有多少?
And I wonder if you could just give us some feedback.
我想知道您是否能給我們一些回饋。
If you deliver the data as per Phase 2, what's your physician feedback on adoption of this therapy in a heavily genericized market and third, fourth line agent as a common as pushback?
如果您按照第 2 階段提供數據,您的醫生對於在仿製藥泛化嚴重的市場以及三線、四線藥物普遍受到反對的情況下採用這種療法有何反饋?
And then the second question is on the SERD.
第二個問題是關於 SERD。
I think investors are generally very confident of SERENA-6 because of the mutant population, but there's been lower confidence in frontline, lower mutation incidents.
我認為,由於突變族群的存在,投資者普遍對 SERENA-6 非常有信心,但對於前線、突變事件較少的信心則較低。
So I wondered if you could just touch on hypotheses, and then you're confident you touched on biology, but some of the other stuff we hear from physicians potentially delaying mutations and sensitivity or combination therapies.
所以我想知道您是否可以談論假設,然後您確信您談到了生物學,但是我們從醫生那裡聽到的其他一些內容可能會延緩突變和敏感性或聯合療法。
Just wonder if you could touch on other hypotheses how you are confident.
只是想知道您是否可以談談其他假設,看看您是如何確信的。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thanks, Sachin.
謝謝,Sachin。
It's nice to move to growth opportunities away from headwinds.
避開逆風,尋找成長機會是件好事。
So Ruud and Susan, maybe?
那麼 Ruud 和 Susan 有可能嗎?
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Yes, let me take the first one.
是的,讓我選第一個。
So the baxdrostat is the combination of the mono components as well as the combination of baxdrostat at Farxiga or dapagliflozin.
因此,baxdrostat 是單一成分的組合,也是 baxdrostat 與 Farxiga 或 dapagliflozin 的組合。
So that's one.
這就是其中之一。
As you can imagine, this will be a crucial year for baxdrostat, and we are doing an enormous amount of market research.
你可以想像,對於 Baxdrostat 來說,這將是至關重要的一年,我們正在進行大量的市場研究。
And it is clear that the high unmet medical need is very clearly resonating with cardiologists and physicians in internal medicine.
顯然,未滿足的醫療需求很高,這引起了心臟病專家和內科醫生的共鳴。
I think the big challenge is going to be the GPs.
我認為最大的挑戰將是全科醫生。
Because a lot of those patients are undiagnosed or are not well treated in the first line.
因為很多病人沒有得到診斷或沒有在第一線得到很好的治療。
And so we're working very hard in order to find a way in order to [educate] the first line moving forward as well.
因此,我們正在努力尋找一種方法來教育第一線人員向前發展。
But there is no doubt that this new [clause] of medicine -- this new way of treating resistant and uncontrolled hypertension is resonating very well with specialty care group of physicians.
但毫無疑問,這種新的醫學[條款]——這種治療難治性和無法控制的高血壓的新方法在專業護理醫生群體中引起了強烈共鳴。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Before we move to SERD, let me just add that if you look at kidney disease, which is a total epidemic in the world, 800 million people have kidney disease today and it's growing. 40% of those patients have a kidney disease from hypertension, 40% from diabetes and the rest is a few other reasons but 40% of these patients.
在我們轉到 SERD 之前,讓我補充一點,如果您看看腎臟疾病,它是一種全球流行病,今天有 8 億人患有腎臟疾病,並且這個數字還在增長。其中40%的患者因高血壓而患有腎臟疾病,40%的患者因糖尿病而患有腎臟疾病,其餘一些原因是其他原因,但也佔這些患者的40%。
Now, several kidney disease is because they have hypertension that is not properly treated, and their blood pressure is not controlled.
現在很多腎臟病都是因為高血壓沒有適當的治療,導致血壓無法控制。
And so we believe that an agent that helps bring those patients to blood pressure control and also potentially affects aldosterone because we believe that the effects of aldosterone is negative, the effect of aldosterone on the kidney or the heart are totally underestimated.
因此我們認為,這種藥物可以幫助這些患者控制血壓,但也可能影響醛固酮,因為我們認為醛固酮的影響是負面的,醛固酮對腎臟或心臟的影響完全低估了。
So if you affect aldosterone and you control (inaudible), which really have a very positive effect on kidney disease in particular.
因此,如果您影響醛固酮並控制(聽不清楚),這確實對腎臟疾病有非常正面的影響。
Susan, do you want to cover the question?
蘇珊,你想回答這個問題嗎?
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Susan Galbraith - Executive Vice President - Oncology and Research and Development
So again, the data that has been seen for the current SERDs have been in later line trials to date, where the proportion of patients that are truly endocrine-sensitive is lower.
因此,再次強調,目前 SERD 的數據來自於迄今為止的後期試驗,其中真正對內分泌敏感的患者比例較低。
And I think that's why you've seen the benefit concentrated in the ESR1 mutant.
我認為這就是您看到 ESR1 突變體集中帶來的好處的原因。
Just as a reminder, as I said, we saw activity in the overall population with a hazard ratio of 0.58 versus fulvestrant, which is the currently available SERD.
提醒一下,正如我所說,我們看到整體人群中的活性與氟維司群(目前可用的 SERD)相比風險比為 0.58。
We know that fulvestrant doesn't maximally degrade the issue in receptor.
我們知道氟維司群不能最大限度地降解受體中的物質。
As a reminder, when you go into the first line in SERENA-4, the comparator is with an inhibitor but doesn't degrade the receptor at all.
提醒一下,當您進入 SERENA-4 的第一行時,比較器帶有抑制劑,但根本不會降解受體。
And that's why we think you're going to have activity in the ESR wild type.
這就是我們認為您將在 ESR 野生型中具有活動的原因。
And again, that builds on the hazard ratio of 0.58. Overall, it wasn't just in the ESR1 mutants that we saw activity.
再次強調,這是基於 0.58 的風險比。總的來說,我們不僅在 ESR1 突變體中看到了活性。
And then we've enriched the patient population in SERENA-4 for patients that are likely to be more endocrine sensitive.
然後,我們豐富了 SERENA-4 中的患者群體,以適應可能對內分泌更敏感的患者。
So in addition to them being first line, which obviously enriches endocrine sensitivity, they had to have adjuvant endocrine therapy for more than two years without progression.
因此,除了作為一線治療,這顯然會增加內分泌敏感性之外,他們還必須接受兩年以上的輔助內分泌治療,並且病情不會出現進展。
So again, those patients that progress rapidly, but less endocrine sensitive.
所以,這些患者病情進展較快,但內分泌敏感度較低。
You had to have a treatment free install more than 12 months since completion of adjuvant therapy without progression on
您必須在完成輔助治療後 12 個月以上未接受任何治療,且病情無進展
(inaudible).
(聽不清楚)。
And I think those features that we've enriched for were carefully chosen in order to maximize the probability of technical success with SERENA-4 as well as for SERENA-6.
我認為,我們精心選擇了這些功能,以最大程度地提高 SERENA-4 和 SERENA-6 的技術成功機率。
Sachin Jain - Analyst
Sachin Jain - Analyst
Sorry, the bax peak sales split mono versus combo, just to get an idea of mono opportunity this year?
很抱歉,bax 峰值銷售分為 mono 和 combo,只是為了了解今年 mono 的機會?
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Sorry?
對不起?
Sachin Jain - Analyst
Sachin Jain - Analyst
The greater $5 billion, do you have a split of that mono versus combo?
在 50 億美元中,單一資產和組合資產是分開的嗎?
The study this year is obviously the mono.
今年的學習明顯是單一的。
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Yes, we haven't disclosed that, Sachin.
是的,我們還沒有透露這一點,Sachin。
So -- and this is a relatively highly competitive field with two components.
所以 — — 這是一個競爭相對激烈的領域,包含兩個部分。
So we have said this substantial on both sides, but we haven't given the split.
因此,雙方都已經表達了這一點,但是我們還沒有給出分割方案。
Mattias Haggblom - Analyst
Mattias Haggblom - Analyst
Mattias Häggblom, Handelsbanken.
Mattias Häggblom,德國商業銀行。
So two questions for Sharon, please.
請問 Sharon 兩個問題。
So first, on the ongoing Phase 2, I think the oral GLP-1s, I'm curious to see how confident you are the 26-week duration of therapy for the primary end point is enough to meet the recently revised FDA guidance and talk about enrollment pace in those studies.
因此首先,關於正在進行的第 2 階段,我認為口服 GLP-1,我很好奇您想了解您對 26 週治療時間作為主要終點是否足以滿足最近修訂的 FDA 指南有多大信心,並談談這些研究中的入組速度。
And then secondly, for the oral PCSK9 with Phase 2b data and our confirm
其次,對於口服 PCSK9,我們有 2b 期數據和我們的確認
(inaudible).
(聽不清楚)。
Help me frame expectations of LDL reductions once the abstract is out and perhaps talk about timelines to a Phase 3 start.
摘要發布後,請幫助我制定 LDL 降低的預期,並討論第三階段開始的時間表。
And perhaps remind me how we win over Merck's oral peptide as it's reading out later this year?
也許可以提醒我,我們如何在今年稍後贏得默克公司的口服勝肽的青睞?
Sharon Barr - Executive Vice President - BioPharmaceuticals R&D
Sharon Barr - Executive Vice President - BioPharmaceuticals R&D
Sure.
當然。
I love these questions.
我喜歡這些問題。
So thank you.
所以謝謝你。
Your first one was about AZD5004, that's our oral GLP-1.
您的第一個問題是關於 AZD5004,這是我們的口服 GLP-1。
And we've been very public about the progress of that.
我們對這項進展一直非常公開。
We released the data at Obesity Week in November of last year.
我們在去年 11 月的肥胖週上發布了這些數據。
This is a true small molecule.
這是一個真正的小分子。
We are envisioning this as a molecule that we are developing both as a monotherapy and in combination with other small molecules already in our portfolio.
我們設想將其開發為一種分子,既可以作為單一療法,也可以與我們產品組合中現有的其他小分子聯合使用。
I mentioned that because we are moving beyond weight loss targets, really thinking about the interconnectedness of cardiovascular, renal and metabolic disease.
我提到這一點是因為我們正在超越減肥目標,並真正思考心血管、腎臟和代謝疾病之間的相互關聯。
So the first step is our two Phase 2b studies, one for patients with obesity or who are overweight and one for patients with type 2 diabetes.
因此,第一步是我們的兩項 2b 期研究,一項針對肥胖或超重患者,一項針對第 2 型糖尿病患者。
Those are the VISTA and APRICUS studies, both are rolling well.
這些是 VISTA 和 APRICUS 研究,兩項研究都進展順利。
And we are on track for the timelines that we previously mentioned.
我們正在按照之前提到的時間表進行。
I'll move on then and speak about our oral PCSK9, which was your second question.
那麼我將繼續談論我們的口頭 PCSK9,這是您的第二個問題。
This is AZD0780.
這是 AZD0780。
So we have completed the Phase 1 data, and we released those last year.
因此,我們已經完成了第一階段的數據,並在去年發布了這些數據。
And in those data, we showed that we were able to reduce LDL at 50% on top of statins, 78% from baseline.
在這些數據中,我們表明,我們能夠在服用他汀類藥物的基礎上將 LDL 降低 50%,比基線降低 78%。
We have just completed the Phase 2b study, PURSUIT.
我們剛完成了第 2b 階段研究,PURSUIT。
We will be releasing those data next month, so hold your breath.
我們將於下個月發布這些數據,所以請大家拭目以待。
But I would expect to share a story that is broadly in line with our Phase 1 data.
但我希望分享一個與我們第一階段數據大致一致的故事。
How do we differentiate this molecule from other PCSK9s?
我們如何將該分子與其他 PCSK9 區分開來?
Well, unlike some of them, it's orally bioavailable.
嗯,與其中一些不同,它是可口服的。
Unlike the other orally bioavailable molecule, it is a true small molecule.
與其他口服生物可利用分子不同,它是一種真正的小分子。
It doesn't require a permeability enhancer, and it doesn't require fasting.
它不需要通透性增強劑,也不需要禁食。
There is no food effect associated with this.
這與食物無關。
So it is well suited to use as a monotherapy but also potentially in combination with other molecules in our portfolio because it is a small molecule, such as the one that I just mentioned, AZD5004, again, addressing the interconnectedness of cardiovascular, renal and metabolic disease.
因此,它非常適合用作單一療法,但也可能與我們產品組合中的其他分子聯合使用,因為它是一種小分子,例如我剛才提到的 AZD5004,再次解決了心血管、腎臟和代謝疾病之間的相互聯繫。
So it has a favorable PK profile.
因此它具有良好的 PK 特性。
It's sets us up well for success, and it lines up in a portfolio of small molecules that really allows us to address interrelated disease.
它為我們的成功奠定了基礎,並且它與一系列小分子結合在一起,真正讓我們能夠治療相互關聯的疾病。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thanks, Sharon.
謝謝,莎倫。
Maybe, Matthias, I mean, differentiation is one thing.
也許,馬蒂亞斯,我的意思是,區分是一回事。
But the -- I think the most important part is to create this market for patients.
但我認為最重要的部分是為患者創造這個市場。
And two companies doing this is far better than only one.
兩家公司這樣做比只有一家公司這樣做好得多。
If you think of PCSK9, they are fantastic drugs.
如果您想到 PCSK9,它們是極好的藥物。
Problem is they're injectable and expensive.
問題是它們是注射劑,而且價格昂貴。
So in the US, you can sort of get them.
在美國,你就可以得到它們。
But in Europe, in most countries, you have to have an event to be able to get a PCSK9 reimbursed, and the steps are complicated.
但在歐洲,大多數國家,必須要有活動才能拿到PCSK9報銷,而且步驟比較複雜。
You have to have a recommendation from cardiologists.
您必須有心臟科醫生的推薦。
Often, you have to get approval from the payer before you can get it.
通常,您必須先獲得付款人的批准才能獲得它。
If you move to (inaudible) agent that is easy to take and then priced at an appropriate level, it can definitely expand the access to these very important medicines.
如果您轉向(聽不清楚)易於服用且價格合理的藥物,那麼肯定可以擴大獲得這些非常重要的藥物的管道。
And then you can go into the emerging markets where also the needs are enormous.
然後你就可以進入新興市場,那裡的需求也同樣巨大。
So I think really expanding this PCSK9 market is going to be a very fundamental priority for our commercial organization.
因此我認為真正擴大 PCSK9 市場將成為我們商業組織的基本優先事項。
Richard Parkes - Analyst
Richard Parkes - Analyst
Richard Parkes from BNP Paribas Exane.
法國巴黎銀行證券部 (BNP Paribas Exane) 的 Richard Parkes。
I've got one for Susan and one for Ruud.
我給蘇珊 (Susan) 和魯德 (Ruud) 各拿了一個。
Firstly, for Susan.
首先,對於蘇珊來說。
You're obviously making a push into next-generation PD-1 bispecific.
您顯然正在努力進軍下一代 PD-1 雙特異性抗體。
You don't, as far as I'm aware, have VEGF in development currently.
據我所知,您目前還沒有 VEGF 發育。
But you do have a TIGIT where I think confidence in that target has been damaged by recent data.
但確實有一個 TIGIT,我認為最近的數據損害了對該目標的信心。
So in terms of VEGF, is that something you would address through partnerships and do combination studies with Dato-DXd?
那麼就 VEGF 而言,您是否會透過合作來解決這個問題並與 Dato-DXd 進行聯合研究?
Or would you develop something internally?
或者你會內部開發一些東西嗎?
And can you talk about your confidence on TIGIT still and the bispecific?
能談談您對 TIGIT 和雙特異性抗體的信心嗎?
Then the second one is for Ruud.
第二個是給魯德的。
You specifically talked about continued growth in the asthma biologics franchise, but you do have GSK coming with a six-monthly depemokimab in the relative in the future.
您特別談到了氣喘生物製劑特許經營的持續成長,但葛蘭素史克公司未來將推出每六個月一次的 depemokimab 藥物。
So can talk about that competitive threat and how you manage to -- how you plan to manage that?
那麼,您能談談競爭威脅以及您如何應對——您計劃如何應對它嗎?
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Okay.
好的。
So again, we presented data from the ARTEMIDE-01 study at the World Congress on Lung Cancer for rilvegostomig in non-small cell lung cancer.
因此,我們再次在世界肺癌大會上展示了 ARTEMIDE-01 研究的數據,該研究針對 rilvegostomig 治療非小細胞肺癌。
And again, we focused the development of this asset on the higher end of the PD-L1, expressing agency.
再次強調,我們將重點放在 PD-L1 的高端,表達機構。
It's the area where I think the data (inaudible) for the TIGIT mechanism.
我認為這是 TIGIT 機制數據(聽不清楚)的領域。
If you just come back to those data, if you look at the PD-L1, greater than 50%, actually we had a 62% response rate in that population and a median PFS of more than 10 months, which is actually, with all the caveats of cross-trial comparisons and small sample sizes as a health warning, that's in the same range as the other bispecifics, including the (inaudible) data.
如果您回顧這些數據,如果您查看 PD-L1,則大於 50%,實際上我們在該人群中的反應率為 62%,中位 PFS 超過 10 個月,實際上,考慮到交叉試驗比較和小樣本量等健康警告,這與其他雙特異性抗體處於同一範圍內,包括(聽不清楚)數據。
What we also have is in the 1% to 49% patient population, again, encouraging data with that asset compared to what you'd expect with a PD-1 agent alone.
我們在 1% 至 49% 的患者群體中也獲得了令人鼓舞的數據,與單獨使用 PD-1 藥物相比。
And importantly, because it's a Fc-silent molecule, it's good combinability with chemotherapy with good safety and low discontinuation rates.
而且重要的是,由於它是一種 Fc 沉默分子,因此它與化療具有良好的結合性,安全性高,停藥率低。
I think they have contributed to some of the failures with combination data that we've seen with other molecules.
我認為它們對我們在其他分子中看到的一些組合數據失敗負有責任。
We do have some Phase 2 trials ongoing for combinations with [rilvegostomig] targeted combinations, for example, in our HCC and gastric studies as well.
我們確實正在進行一些與 [rilvegostomig] 標靶組合的 2 期試驗,例如在我們的 HCC 和胃研究中。
The good news is that we've got good safety for combination of rilvegostomig with that agent.
好消息是,我們發現 rilvegostomig 與該藥物的聯合使用具有良好的安全性。
And I think where the VEGF mechanism has also shown on its own that there's activity, that is the place where you're probably most likely to see the interaction between both in IO and the VEGF mechanism.
我認為 VEGF 機製本身也表現出活性,這也是您最有可能看到 IO 和 VEGF 機制之間相互作用的地方。
So I think there's opportunity for us to build on the backbone of rilvegostomig with some combinations with VEGF-directed agents.
因此我認為我們有機會在 rilvegostomig 的基礎上與一些 VEGF 標靶藥物進行組合。
That's something that we're obviously -- we'll be looking at as well beyond the HCC and the gastric studies that we've already got ongoing.
顯然,我們會繼續研究這一點,而不僅僅是 HCC 和胃部研究,我們已經在進行這些研究。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thanks, Susan.
謝謝,蘇珊。
Ruud?
魯德?
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Sure, I'll take the second one.
當然,我會選擇第二個。
So first of all, I think the market opportunity in itself is still very, very substantial.
所以首先,我認為市場機會本身仍然非常非常大。
The bio penetration of biologics in the asthma segment, on average, is only 20%.
生物製劑在氣喘領域的生物滲透率平均僅 20%。
So clearly, there's a substantial room for further improvement there.
顯然,還有很大的進步空間。
Secondly, based on our own Fasenra, which is a two-month injection, we know that, yes, it's important from a convenience perspective.
其次,基於我們自己的 Fasenra(一種為期兩個月的注射劑),我們知道,從便利性的角度來看,這很重要。
But the end game is always efficacy.
但最終的結果總是以功效為準。
It's very important that physicians, but certainly patients, feel that efficacy is the most important piece.
讓醫生,尤其是患者感到療效是最重要的,這點非常重要。
And the reason that Fasenra has performed so well in the severe uncontrolled asthma segment is that the efficacy is very high, and the level of satisfaction is very high.
而Fasenra之所以在嚴重未控制氣喘領域表現如此出色,是因為其療效非常高,且滿意度很高。
So in that sense, competition is not bad, but I think the bar in order to move Fasenra away from the market leadership currently are having, (inaudible), I think, is very high.
因此從這個意義上來說,競爭並不壞,但我認為,為了讓 Fasenra 擺脫目前的市場領導地位,門檻非常高。
Equally, of course, we have an unprecedented possibility in China.
當然,同樣,我們在中國也擁有前所未有的可能性。
We all get Fasenra hopefully later this year in NRDL.
我們希望今年稍後能在國家健保目錄裡看到 Fasenra。
We're clearly the market leader in China from a respiratory perspective.
從呼吸角度來看,我們無疑是中國市場的領導者。
So in that sense, we are very bullish regarding the outlook for Fasenra moving forward despite potential more competition.
因此從這個意義上來說,儘管可能面臨更多競爭,但我們對 Fasenra 未來的前景非常看好。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you, Ruud.
謝謝你,魯德。
Let's move to Steve Scala online.
讓我們轉到 Steve Scala 在線。
Steve, over to you.
史蒂夫,交給你了。
Can you hear us?
你聽得到我們的聲音嗎?
Steve Scala - Analyst
Steve Scala - Analyst
Yes.
是的。
Two questions.
兩個問題。
First, regarding Tagrisso, is your confidence in the outlook predicated on growth in adjuvant?
首先,關於 Tagrisso,您對佐劑成長前景的信心是否基於此?
Or do you think Tagrisso will remain dominant in first line or perhaps both?
或者您認為塔格里索 (Tagrisso) 將繼續佔據一線主導地位,或者兩者兼而有之?
And has the first-line outlook been influenced by the MARIPOSA OS data?
第一線前景是否受到 MARIPOSA OS 資料的影響?
So that's the first question.
這是第一個問題。
Second question is the fact that this duty has been assessed against AstraZeneca in China, suggesting corporate Astra has been implicated in the investigation.
第二個問題是,阿斯特捷利康在中國已被徵收反傾銷稅,這意味著阿斯特捷利康公司已捲入調查。
Previously, Astra was not part of the investigation.
此前,阿斯特拉並未參與調查。
So if it's now part of it, what are the implications of that?
那麼如果它現在是其中的一部分,那麼其意義是什麼?
Thank you.
謝謝。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Dave?
戴夫?
David Fredrickson - Executive Vice President - Oncology Business Unit
David Fredrickson - Executive Vice President - Oncology Business Unit
So Steve, thanks for the question.
史蒂夫,謝謝你的提問。
On the first part of your Tagrisso question, we saw in 2024, very nice growth in ADAURA, LAURA, where we've launched it, but also a really strong launch to FLAURA2.
關於您關於 Tagrisso 問題的第一部分,我們在 2024 年看到,我們推出的 ADAURA 和 LAURA 實現了非常好的成長,而且 FLAURA2 的推出也非常強勁。
And I'll note that FLAURA2, we've launched now in 65 markets across the globe.
我要指出的是,FLAURA2 現已在全球 65 個市場推出。
So we've had an opportunity to really get out and be able to tell the Tagrisso backbone story and then also the opportunity to be able to (inaudible) combination in FLAURA2.
因此,我們有機會真正走出去,講述 Tagrisso 的主幹故事,然後也有機會(聽不清楚)將其與 FLAURA2 結合起來。
As we look at the impact that MARIPOSA is having, certainly, the overall survival that has been shared as high-level results is something that -- anything at a year of overall survival, I think, is catching attention of the community.
當我們看到 MARIPOSA 產生的影響時,毫無疑問,作為高水平結果而分享的總體生存率是——我認為,一年總體生存率的任何變化都引起了社會的關注。
With that said, based on the data that the community saw at ELCC in 2024 for FLAURA2, where we saw really, very, very competitive FLAURA2 landmark survival rates of 80% at 24 months, 64% at 36 months.
話雖如此,根據社區在 2024 年 ELCC 看到的 FLAURA2 數據,我們看到 FLAURA2 的里程碑式存活率確實非常有競爭力,24 個月為 80%,36 個月時為 64%。
I think that there's a general expectation that FLAURA2 is also moving in absolutely the right direction in this regard.
我認為人們普遍期待 FLAURA2 在這方面也朝著絕對正確的方向發展。
And the utilization that we're hearing is -- for MARIPOSA is a lot in second line and actually quite a lot of trial but not repeat use.
我們聽到的利用情況是 - 對於 MARIPOSA 來說,很多都是二線藥物,實際上有很多是試驗性的,但並沒有重複使用。
And the only last thing that I'd just say, let me take this opportunity.
我最後想說的是,請容許我藉此機會說幾句話。
In my prepared remarks, I had mentioned that the market share was 85% in the US, and I should have said that, that was in Japan.
我在準備好的發言中提到,美國的市佔率是 85%,但我應該說,那是在日本。
So that was something that I had said.
這就是我說過的話。
The global frontline EGFR market share is 75%.
全球第一線EGFR市佔率為75%。
That's inclusive of the US.
其中包括美國。
And in Japan, it's higher at 85%.
日本的比例更高,達85%。
So that's just something I wanted to clarify.
我只是想澄清一點。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thanks, Dave.
謝謝,戴夫。
And the second question, Steve, is relatively straightforward.
第二個問題,史蒂夫,相對簡單。
The -- as I said before, the notice has been sent to the prosecutor's office.
正如我之前所說,通知已經發送到檢察官辦公室。
If AstraZeneca is found liable the Chinese law is very, very clear, the implication is very clear, which is the company has to repay the import duties, so $0.9 million, $900,000 to be repaid plus a fine that is 1 to 5 times the amount of import duties.
如果阿斯特捷利康被判有罪,中國法律的規定非常非常明確,意義也非常清楚,那就是該公司必須償還進口關稅,也就是 90 萬美元,需要償還 90 萬美元,外加相當於進口關稅 1 到 5 倍的罰款。
So it could be $0.9 million plus $0.9 million or it could be $0.9 million plus $4.5 million.
因此,它可能是 90 萬美元加 90 萬美元,也可能是 90 萬美元加 450 萬美元。
That's the implication, and it's very, very clearly defined by Chinese law.
這就是意義,中國法律對此有非常明確的規定。
Andy, you will tell me when we have to run out.
安迪,當我們用完的時候你會告訴我。
We have to stop because I know some of you have to go to another meeting.
我們必須停下來,因為我知道你們中的一些人必須去參加另一個會議。
Emily Field - Analyst
Emily Field - Analyst
Emily Field from Barclays.
巴克萊銀行的 Emily Field。
Two on Oncology.
兩篇關於腫瘤學的。
Firstly, on Datroway, a great label from a safety perspective with no box warning relative to other TROP2 ADC, do you expect that to hold for a potential approval in non-small cell lung cancer?
首先,從安全性角度來看,Datroway 是一個很好的標籤,與其他 TROP2 ADC 相比沒有任何黑框警告,您是否預計這款藥物將在非小細胞肺癌領域獲得批准?
And then another question on the SERD, we will be seeing the [all-comers] results from the competitor giredestrant this year.
然後是關於 SERD 的另一個問題,今年我們將看到競爭對手 giredestrant 的 [全部參賽者] 結果。
I was just wondering if you could help us utnderstand why some of the molecular advantages of camizestrant over the competitor molecule.
我只是想知道您是否可以幫助我們理解為什麼卡米司特蘭比競爭對手的分子具有一些分子優勢。
Thank you.
謝謝。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Susan?
蘇珊?
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Yes, sure.
是的,當然。
So obviously, we're still in discussions with regulatory authorities about the filing for Datroway in the EGFR mutant lung cancer setting.
顯然,我們仍在與監管機構討論 Datroway 在 EGFR 突變肺癌治療中的申請。
But we did publish the safety data that's the basis of that filing earlier.
但我們之前確實發布了作為該文件依據的安全資料。
So you can look at the adverse event profile that is there, and I think within the EGFR mutant population.
因此,您可以查看那裡的不良事件概況,我認為是在 EGFR 突變人群中。
That's in line with the current label that you've got in the breast cancer setting.
這與您在乳癌環境中獲得的當前標籤一致。
So we have to wait for the final leg, assuming that the rest of the filing goes well.
因此我們必須等待最後階段,假設其餘的申請進展順利。
In terms of the camizestrant molecule, I think we've got a very good potency.
就卡馬西平分子而言,我認為我們已經獲得了非常好的效力。
We've got very good linear PK.
我們已經獲得了非常好的線性 PK。
We've got very good, clean profile with all of the combination partners that we're looking to combine with, including all of the CDK 4/6s.
我們與所有想要合併的組合夥伴都擁有非常良好、清晰的資料,其中包括所有 CDK 4/6。
The safety profile that we're seeing with camizestrant leads to an extremely low discontinuation rate, very low rates of the GI side effects, which I think is important particularly when you go into the earlier lines of therapy.
我們看到的卡米司群的安全性使其停藥率極低,胃腸道副作用發生率也非常低,我認為這非常重要,特別是在早期治療時。
People want to stay on drug for a long period of time.
人們希望長期服藥。
So I think the overall profile that we have with this drug is really looking best in class from our perspective.
因此我認為,從我們的角度來看,這種藥物的整體概況確實是同類藥物中最好的。
Obviously, we've got to have the trial read out first, and then we can happily discuss the actual profile that we've seen in the Phase 3 trials.
顯然,我們必須先宣讀試驗結果,然後我們才能愉快地討論我們在第 3 階段試驗中看到的實際情況。
But at this point, we're confident.
但目前,我們有信心。
Simon Baker - Analyst
Simon Baker - Analyst
Simon Baker from Redburn Atlantic.
來自 Redburn Atlantic 的 Simon Baker。
Two quick ones, if I may.
如果可以的話,我快速問兩個問題。
Just going back to rilvegostomig.
剛剛回到 rilvegostomig。
Susan, could you give us your updated thoughts, and you could touch on this, on the scope for TIGIT as a target beyond non-small cell lung cancer based on what you now know?
蘇珊,您能否告訴我們您的最新想法,並談談這一點,根據您現在的了解,TIGIT 作為非小細胞肺癌以外治療範圍的範圍?
And then one for Iskra on emerging markets.
接下來是 Iskra 對新興市場的討論。
The growth ex China look very good. if you could give us some highlights of sort of country by country where you are seeing that growth.
中國以外的成長看起來非常好。您可以向我們介紹每個國家的成長亮點嗎?
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Susan Galbraith - Executive Vice President - Oncology and Research and Development
Okay.
好的。
Thank you.
謝謝。
So rilvegostomig, obviously, we've -- in addition to the lung cancer indications with TROPION-Lung10 in combination with Datroway and the ARTEMIDE-Lung02 and Lung03 trials in combination with chemotherapy, we've got the ARTEMIDE-Biliary01 study, which builds on the TOPAZ data that we had with durvalumab in biliary tract cancer that takes it into the adjuvant therapy.
因此,顯然,我們除了使用 TROPION-Lung10 與 Datroway 聯合治療肺癌以及使用 ARTEMIDE-Lung02 和 Lung03 試驗與化療聯合治療肺癌之外,還進行了 ARTEMIDE-Biliary01 研究,該研究以我們在膽道癌中使用 durvalumab 的 TOPAZ 數據為基礎,將其納入輔助治療。
That's -- I think, I would say, that the investigators are very enthusiastic about.
我想說,這是調查人員非常熱衷的事。
And then the next piece in terms of the expansion is clearly building on the combinations that we've already got with Datroway.
那麼,擴展方面的下一步顯然是以我們已經與 Datroway 達成的組合為基礎的。
There's also good combination capability with Enhertu and then with the other ADCs that we've got coming through the portfolio.
Enhertu 以及我們透過產品組合獲得的其他 ADC 也具有良好的組合能力。
I think there'll be significant opportunity.
我認為這將是一個重大機會。
We are focused on those patient populations where TIGIT is likely to be more beneficial.
我們重點關注那些 TIGIT 可能更有益的患者群體。
But that has been seen in indications also like gastric cancer, for example.
但這也已在胃癌等症狀中展現出來。
And HCC cancer, you would expect activity from the TIGIT mechanism of action beyond what you see.
對於肝細胞癌,您可以預期 TIGIT 作用機制的活性會超出您所看到的範圍。
Iskra Reic - Executive Vice President - International
Iskra Reic - Executive Vice President - International
Simon, if you look at the emerging markets outside of China, as I mentioned, I mean, growth is quite impressive.
西蒙,如果你看看中國以外的新興市場,正如我所提到的,你會發現,它們的成長相當令人印象深刻。
It's another strong year to growth of 32%.
今年又是強勁成長的一年,成長率達到 32%。
And the emerging markets, if you exclude China, actually represents up to 13% of the global revenues.
如果不包括中國,新興市場實際上佔全球收入的 13%。
And we are very confident and positive in the further growth in the emerging market.
我們對新興市場的進一步成長非常有信心,並且持正面態度。
And therefore, the answer to your question is very difficult because we actually see the super strong double-digit growth across Latin America, Asia, Middle East and Africa areas.
因此,回答你的問題非常困難,因為我們實際上看到拉丁美洲、亞洲、中東和非洲地區都出現了強勁的兩位數成長。
And we do see the good reasons and the good -- many growth drivers to see that continue.
我們確實看到了充分的理由和良好的發展動力,並相信這一趨勢能夠持續下去。
And I think one important point is that across the emerging markets, we are actually launching our brand a bit later than when comparing with US and Europe.
我認為重要的一點是,在新興市場中,與美國和歐洲相比,我們推出品牌的時間實際上要晚一些。
If you think about that, I mean, the products like Breztri or like Enhertu are still to get the full maximum and full leverage across the international region.
如果你考慮一下,我的意思是,像 Breztri 或 Enhertu 這樣的產品仍需在國際地區獲得最大限度和充分的槓桿作用。
So despite the headwinds that we will always see, as Pascal mentioned a bit of the pricing or the exchange rate, I do believe that underlying growth across all areas in emerging markets is to be continued across all therapy areas as well.
因此,儘管我們總是會看到逆風,就像帕斯卡提到的一些定價或匯率問題,但我相信新興市場所有領域的潛在成長也將繼續存在於所有治療領域。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
I mean, I think it's important to -- just to add to this, it's important to remember that the population is there.
我的意思是,我認為重要的是——補充一點,重要的是要記住那裡有人口。
The global population lives outside the US and Europe and most of the population.
全球人口居住在美國和歐洲以外,佔人口總數的大多數。
And many of those countries are becoming richer, their economies are developing, more funds can be allocated to healthcare.
許多國家正在變得更加富裕,經濟正在發展,可以為醫療保健分配更多的資金。
And we have the portfolio of products that address most of the pricing needs, medical needs in many of those countries.
我們的產品組合可以滿足大多數國家的大部分定價需求和醫療需求。
The other thing we've done is we've accelerated the approval of new products.
我們所做的另一件事是加快了新產品的批准。
In the past, these countries were sort of priority 3, of course, US, Europe first, and we had a long delay between the launch in Europe or US and the launch in those countries.
過去,這些國家的優先等級是第三位,當然是美國和歐洲優先,而我們在歐洲或美國的發布與在這些國家的發布之間有著很長的延遲。
We've accelerated this.
我們已經加速了這一進程。
Team has done an amazing job.
團隊做出了出色的工作。
And so we're bringing those medicines to all these countries much faster than before.
因此,我們能夠比以前更快地將這些藥品運送到所有這些國家。
So there's really good reasons to believe that we will continue to grow.
因此我們有充分的理由相信我們將繼續成長。
And in many, not all, but many of these countries, we don't experience the impact of patent expiries like we have in the US or Europe because those products are sort of sold as a brand, lower priced, but less exposure to patent expiries and you just compete with generics as opposed to losing it all when you lose patent protection.
在許多(不是全部,但大部分)國家中,我們不會像在美國或歐洲那樣受到專利到期的影響,因為這些產品是以品牌形式出售的,價格較低,但受專利到期影響較小,您只需與仿製藥競爭,而不會在失去專利保護時失去一切。
Eric Le Berrigaud - Analyst
Eric Le Berrigaud - Analyst
Eric Le Berrigaud, Stifel.
艾瑞克·勒貝里戈(Eric Le Berrigaud),Stifel。
Two questions.
兩個問題。
First, we do appreciate that your top priority is on top line growth, both short and longer term.
首先,我們非常理解您的首要任務是短期和長期的營收成長。
But my question is on margin development.
但我的問題是關於利潤率的發展。
We were probably expecting margin to end at around 32% in '24 and ended just above 31%.
我們原本預期利潤率將在 24 年達到 32% 左右,但實際僅 31% 左右。
So you reiterated commitment to reach mid-30s by '26, which leaves a gap by around 400 basis points over the next couple of years.
因此,您重申了到 26 年達到 35% 左右的承諾,這將在未來幾年留下約 400 個基點的差距。
Given the current guidance for '25, it looks like the leverage will be quite minimal this year.
鑑於目前對25年的指導方針,看起來今年的槓桿率將非常小。
So it leaves a lot into '26.
因此,還有很多事情要留給 26 年去做。
So how should we think about this development?
那我們該如何看待這項發展?
Are we right in assuming that mid-30s means 35%?
我們是否可以假設 35 歲左右意味著 35%?
Or could that be a broader range?
或者說範圍可以更廣嗎?
And would you be comfortable reaching 34% or just to give kind of a sense also for consensus adjustments?
您是否願意達到 34% 或只是給出共識調整的感覺?
And the second question is on Airsupra.
第二個問題是關於 Airsupra 的。
If I remember correctly, it was supposed to be a multi-blockbuster in the end, and you were probably more bullish than consensus.
如果我沒記錯的話,它最終應該是一部多部大片,而你可能比普遍預期的更樂觀。
And the start is relatively soft, and we haven't seen much of an improvement in even the fourth quarter.
而且開局相對疲軟,甚至在第四季我們也沒有看到太大的改善。
So there was a lot of development around free sampling and probably formulary access.
因此,在免費樣品和可能的處方訪問方面取得了很大的進展。
Is it getting better moving into '25?
進入'25年後情況會好轉嗎?
And should we expect a significant improvement on the products in '25?
我們是否應該期待25年的產品有顯著的改進?
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Aradhana?
阿拉達那?
And then maybe
然後也許
--
--
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
Sure.
當然。
So we do expect to see operating margin expansion this year.
因此我們確實預計今年的營業利潤率將會擴大。
So if you look at our guide for revenue and EPS and you can extrapolate sort of what the operating margin could be.
因此,如果您查看我們的收入和每股盈餘指南,您就可以推斷出營業利潤率是多少。
So there is clearly an expansion between '24 and '25.
因此,'24 和 '25 之間顯然存在著擴張。
I also mentioned in my prepared remarks the impact that FX has.
我在準備好的發言中也提到了外匯的影響。
And again, that was not obviously the case in '24, but when you look at where the currencies have moved, particularly in the last two, three months, that does have an impact of, as I mentioned, 20 basis points in -- on our margins for this year and 50 basis points, if you compare it to the first quarter 2024 rates.
再說一次,這在 2024 年顯然不是這種情況,但是當你觀察貨幣的走勢時,特別是在過去的兩三個月裡,這確實對我們今年的利潤率產生了 20 個基點的影響,如果與 2024 年第一季度的利率相比,則會產生 50 個基點的影響。
Other than that, I would say, me and all the entire executive team is very much committed to achieving that mid-30s operating profit.
除此之外,我想說,我和整個執行團隊都非常致力於達到 35% 左右的營業利潤。
So mid-30s is 34% to 36%, which is always what we have signaled.
因此 35 歲左右是 34% 到 36%,這正是我們一直所暗示的。
And we have a number of initiatives, whether it's optimizing our commercial footprint, seeing where we do work.
我們採取了多項舉措,包括優化我們的商業足跡,了解我們的工作地點。
So you've probably seen the hubs we have opened in Mississauga and Barcelona and Bangalore and other places, again taking advantage of work we're doing.
所以你可能已經看到我們在密西沙加、巴塞隆納、班加羅爾和其他地方開設的樞紐,再次利用我們正在做的工作。
We're also doing a lot of process improvements, whether it's in regulatory filings and so forth.
我們也進行了許多流程改進,無論是在監管備案方面還是其他方面。
So there are a whole bunch of different initiatives that are happening across the company on driving productivity while still supporting, obviously, a very large and growing portfolio.
因此,整個公司正在採取一系列不同的措施來提高生產力,同時顯然仍要支援非常龐大且不斷成長的產品組合。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Yes.
是的。
Ruud on Airsupra?
魯德加入 Airsupra 了嗎?
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Yes, quickly.
是的,很快。
First of all, what I'm still very excited about Airsupra, first of all, we see an enormous volume, over 300,000 scripts in one year
首先,我對 Airsupra 仍然感到非常興奮,首先,我們看到了巨大的數量,一年內就有超過 300,000 個腳本
(inaudible).
(聽不清楚)。
And that's also the challenge in the spirit of transparency.
這也是透明精神所面臨的挑戰。
One out of two scripts are not fulfilled at the pharmacy level because, still, of access issues.
由於有取得問題,一半的處方無法在藥局層級得到滿足。
This is a very highly genericized market, and clearly, it's much more difficult than we expect it in order to get traction because albuterol, ventolin has a very, very low price.
這是一個高度通用的市場,而且顯然,要獲得發展動力比我們預期的要困難得多,因為沙丁胺醇、萬託林的價格非常非常低。
And we don't want to compromise at this stage of the game too much our price.
在這個階段,我們不想在價格上做出過多的妥協。
We want to sell it basically on the clinical features of Airsupra.
我們希望主要根據 Airsupra 的臨床特徵來銷售它。
The other big piece of excitement is that we have published why these are the high-level results of the BATURA data, which further expands the potential of using Airsupra in the mouth asthma segment.
另一件令人興奮的事情是,我們已經發表了為什麼這些是 BATURA 數據的高級結果,這進一步擴大了在口腔氣喘領域使用 Airsupra 的潛力。
And last but not least, more than 65,000 physicians in United States have already prescribed Airsupra.
最後但同樣重要的一點是,美國已有超過 65,000 名醫生開出了 Airsupra。
So it's all about access.
所以一切都與訪問有關。
We were making good progress.
我們正在取得良好的進展。
Through January 1, we have now roughly a coverage of 60% of commercial lives.
截至 1 月 1 日,我們現在已經涵蓋了大約 60% 的商業生活。
We have secured one very large Part D access.
我們已經獲得了一個非常大的 D 部分存取權限。
So it will take some time.
所以這需要一些時間。
The good news is in [health] therapies, the tail is very long.
好消息是,(健康)療法的前景十分光明。
You see it yourself, the performance of Symbicort.
您可以親眼看到 Symbicort 的效能。
So we are very committed in order to capture this opportunity moving forward, and we are working very hard on the access situation.
因此,我們非常致力於抓住這個機遇,並正在努力改善准入情況。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
I mean, you know that when you launch a new product access is always something that takes time, even more so here because of the reason Ruud described.
我的意思是,你知道當你推出新產品時,取得存取權限總是需要時間的,而由於 Ruud 所描述的原因,這裡更是如此。
But we're making good progress.
但我們正在取得良好進展。
And the important piece, I think, is BATURA, the study that Ruud mentioned.
我認為,最重要的是 Ruud 提到的 BATURA 研究。
Because fundamentally, you've got to convince managed care of the economic value of reimbursing these products when they have, of course, generic albuterol that they can offer patients.
因為從根本上來說,你必須讓管理式醫療機構相信,當他們可以為病人提供通用的沙丁胺醇時,報銷這些產品具有經濟價值。
And BATURA data will certainly be very important tool in convincing them of the cost effectiveness of reimbursing Airsupra.
而 BATURA 數據無疑將成為說服他們償還 Airsupra 的成本效益的重要工具。
The clinical data are very, very striking.
臨床數據非常非常驚人。
Justin Smith - Analyst
Justin Smith - Analyst
It's Justin from Bernstein.
我是伯恩斯坦的賈斯汀。
I've got one for Marc on efzimfotase, just if you wanted to share any thoughts on the cost of goods versus Strensiq.
我有一份關於 efzimfotase 的資訊給 Marc,如果你想分享關於該商品與 Strensiq 的成本對比想法的話。
And the second one for Aradhana, just if you could possibly give any kind of color on CapEx after 2025.
第二個問題是針對 Aradhana 的,如果您可以對 2025 年以後的資本支出給出一些說明的話。
Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca
Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca
So in short, the cost of goods is, for efzimfotase, is way under that of Strensiq.
簡而言之,efzimfotase 的商品成本遠低於 Strensiq。
And our ambition is to be able to reach out to 6 times the number of patients as we do for Strensiq, not only for a cost of good reason but also because we are also going to address the adult population and a much wider regional expansion.
我們的目標是能夠覆蓋比 Strensiq 數量多 6 倍的患者,這不僅是因為成本合理,還因為我們還將針對成年人口並實現更廣泛的區域擴展。
So the cost of good is only one factor in this.
因此,商品成本只是其中一個因素。
The development -- the clinical development plan in both pediatric and adult is important, and the regional expansion where, today, Strensiq is still relatively limited to a certain number of countries.
兒科和成人臨床開發計劃的發展非常重要,而區域擴張目前仍相對局限於一定數量的國家。
And we are expanding year after year.
而且我們的規模逐年擴大。
But with efzimfotase alfa, this expansion will be much easier and much wider.
但有了 efzimfotase alfa,這種擴充將變得更加容易和廣泛。
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
As it relates to CapEx, I think a good way to think about sort of from a forward standpoint would be that these are all multiyear projects.
至於資本支出,我認為從前瞻性角度考慮的一個好方法是,這些都是多年期專案。
So some of them, we started last year or the year before, so like the API facility, the cell therapy, we started last year.
其中一些是我們去年或前年開始的,例如 API 設施、細胞療法,都是我們去年開始的。
The ADC we will start this year, (inaudible), we started last year.
我們今年將啟動的 ADC,(聽不清楚),我們去年就開始了。
So you should expect that these go for at least four or five years, same with the ERP project.
因此你應該預期這些至少需要四到五年,ERP 計畫也是如此。
And so this would be a good level for the next several years.
因此這對於未來幾年來說將是一個很好的水平。
Again, if there are new projects started, for example, if we have great success with the GLP-1 or something, then we'd announce those separately.
再說一次,如果有新的專案啟動,例如,如果我們在 GLP-1 或其他方面取得了巨大成功,那麼我們會單獨宣布這些專案。
But this is a good way to think that these are multiyear projects.
但這是一個很好的想法,因為它們是多年期專案。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you.
謝謝。
It was good you asked the question about the efzimfotase because I think this product is underestimated.
很高興您問了有關 efzimfotase 的問題,因為我認為這個產品被低估了。
Potential we said is quite substantial.
我們說的潛力是相當大的。
There's no competition.
沒有競爭。
Profitability will be good.
盈利能力將會良好。
The unmet need is important and large.
未滿足的需求很重要且規模很大。
So we believe it is going to be a very important product, not only for Alexion but for AstraZeneca.
因此我們相信它將是一款非常重要的產品,不僅對 Alexion 而且對 AstraZeneca 來說都是如此。
Should I take maybe the last question online, Andy, and then close?
安迪,我是否應該在線回答最後一個問題然後關閉?
So we -- sorry.
所以我們——抱歉。
There's still on the room.
房間裡還有東西。
Sorry, I missed that.
抱歉,我忽略了這一點。
Rajan Sharma - Analyst
Rajan Sharma - Analyst
It's Rajan Sharma from Goldman Sachs.
他是高盛的拉詹·夏爾馬。
First question, just to follow up on the oral PCSK9, actually.
第一個問題,其實只是為了跟進口服 PCSK9。
Do you think that you need a cardiovascular outcomes trial or a positive one to get meaningful uptake?
您是否認為需要進行心血管結果試驗或積極試驗才能獲得有意義的吸收?
And what would be kind of your thoughts around initiating that trial, particularly thinking that you might need one for the oral GLP-1 as well?
您對啟動這項試驗有什麼想法,特別是您是否認為口服 GLP-1 也需要一項試驗?
And then the second question was just on AVANZAR and potential filing strategy there.
第二個問題是關於 AVANZAR 及其潛在的申請策略。
Assuming that is positive on PFS, do you think that will be enough for a condition on approval?
假設這對 PFS 來說是積極的,您認為這足以成為批准的條件嗎?
Sharon Barr - Executive Vice President - BioPharmaceuticals R&D
Sharon Barr - Executive Vice President - BioPharmaceuticals R&D
Sure.
當然。
So I'll jump in and answer the question on the oral PCSK9.
因此我將立即回答有關口頭 PCSK9 的問題。
I appreciate the question.
我很感謝你提出這個問題。
I recognize that we are just now completing Phase 2 and planning for our pivotal study.
我知道我們現在剛完成第二階段併計劃我們的關鍵研究。
We're not going to comment today on what our plans are for outcomes trials.
我們今天不會對結果試驗的計劃發表評論。
We have been public about our expectation for the need for outcomes trials in oral GLP-1.
我們已經公開表達了對口服 GLP-1 結果試驗需求的預期。
And it's a little early to comment on what we plan to do for AZD0780, but thanks for the question.
現在評論我們計劃對 AZD0780 做什麼還為時過早,但還是感謝您的提問。
Aradhana Sarin - Chief Financial Officer, Executive Director
Aradhana Sarin - Chief Financial Officer, Executive Director
In terms of PFS as an endpoint in first-line non-small cell lung cancer, there have been approvals with full approvals based on PFS.
就PFS作為非小細胞肺癌第一線治療終點而言,目前已有完全以PFS為依據的核准。
In general, the regulatory agencies are going to want to see a positive trend in OS and reasonable maturity of the endpoint.
整體而言,監管機構希望看到作業系統呈現正面趨勢,端點趨於合理成熟。
So those are just things to consider.
所以這些只是需要考慮的事情。
Rajan Sharma - Analyst
Rajan Sharma - Analyst
One question.
一個問題。
I appreciate you've got a 2030 target of $80 billion revenue, and that's more of an organic number.
我很欣賞你們設定的 2030 年收入目標,即 800 億美元,這是一個更自然的數字。
If we look at your balance sheet, you will start generating more capacity to redeploy capital.
如果我們看一下你的資產負債表,你將開始產生更多的能力來重新部署資本。
What are your therapeutic area capital allocation?
您的治療領域資金配置是怎麼樣的?
I mean, I appreciate Oncology has been very attractive for you.
我的意思是,我很欣賞腫瘤學對你來說非常有吸引力。
And when we started, TIGIT suddenly was very interesting, and people are now asking you if VEGF is more interesting.
當我們開始時,TIGIT 突然變得非常有趣,人們現在問您 VEGF 是否更有趣。
So are there therapy areas where you think it's getting a bit more difficult to find incremental opportunities?
那麼,您認為在哪些治療領域尋找增量機會變得越來越困難呢?
Or you're still excited about equal amount of capital in all therapy areas?
或者您仍然對所有治療領域的同等資本感到興奮?
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Yes, it's a great question.
是的,這是一個很好的問題。
The exciting part of our industry at this point is, it's also the scary part, I must say, is that, I mean, the innovation is incredible.
我必須說,我們這個行業目前最令人興奮也是最可怕的部分是,創新令人難以置信。
And the speed of replacement of technology is incredible.
而且技術更替的速度令人難以置信。
And that's why I believe -- I continue to believe that being focused on a few key therapy areas and building competence, building expertise is fundamental because you actually understand much better what are the promising new technologies or products that are emerging and how you develop them, how you commercialize them, and you have an end-to-end understanding of a specific therapy area.
這就是為什麼我相信——我仍然相信,專注於幾個關鍵治療領域並建立能力、建立專業知識是至關重要的,因為這樣你實際上可以更好地了解正在出現的有前景的新技術或產品是什麼,以及如何開發它們,如何將它們商業化,並且對特定的治療領域有端到端的了解。
So our approach is really to continue to focus on oncology, respiratory disease, cardiovascular disease.
因此,我們的方法是繼續關注腫瘤學、呼吸系統疾病和心血管疾病。
Immunology, we want to address it through a few products we are working on, but also cell therapy, we believe, could be a very important angle to treat some of these immune diseases and, of course, finally, rare diseases.
我們希望透過我們正在研究的幾種產品來解決免疫學問題,但我們也相信細胞療法可能是治療某些免疫疾病以及罕見疾病的一個非常重要的角度。
But we will continue to stay focused on this and build access to new technologies.
但我們將繼續關注這一點並建立獲取新技術的管道。
We've talked about ADC, T-cell engager, cell therapy, bispecifics, radiopharmaceuticals.
我們討論了 ADC、T 細胞接合劑、細胞療法、雙特異性抗體、放射性藥物。
There is a whole range of technologies that have emerged in the last few years.
近幾年出現了各種各樣的技術。
And actually, there's reason to believe it will continue to happen.
事實上,我們有理由相信這種情況會繼續發生。
And it's actually fantastic, fantastic for patients, for medicine, fantastic for us to participate in this, bring those medicines to patients.
這確實是一件非常棒的事情,對於患者來說非常棒,對於醫學來說也非常棒,對於我們來說能夠參與其中,將這些藥物帶給患者也非常棒。
The reason I was saying it's scary is that it actually keeps us all on our toes right?
我之所以說它很可怕,是因為它實際上讓我們所有人都保持警惕,對嗎?
We have to make sure we actually scan the horizon constantly and we don't get caught with something that is coming from left field that actually replaces our products.
我們必須確保我們確實在不斷地審視未來,並且不會被突然冒出來的、可以取代我們產品的東西所困擾。
I mean, you see it yourself, I mean, products coming out of the woodwork and really transforming the treatment of an indication.
我的意思是,您可以親眼看到,產品的出現確實改變了疾病的治療方法。
So maybe I'll take the online one, and then we'll let you go.
所以也許我會選擇在線的,然後我們再讓你走。
Gonzalo, Danske Bank, do you want to go ahead?
貢薩洛,丹麥銀行,你想繼續嗎?
Gonzalo Artiach - Analyst
Gonzalo Artiach - Analyst
Yes, Can you hear me, guys?
是的,大家聽得到我說話嗎?
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Yes.
是的。
Go ahead.
前進。
Gonzalo Artiach - Analyst
Gonzalo Artiach - Analyst
Okay.
好的。
Great.
偉大的。
Thanks for taking my questions.
感謝您回答我的問題。
Gonzalo Artiach from Danske Bank.
丹麥銀行的 Gonzalo Artiach。
Two questions.
兩個問題。
One on Datroway.
一個在 Datroway。
And what type of launch do you expect in the TROPION-Breast01 setting, previously growth potential in that population.
您期望在 TROPION-Breast01 環境中推出什麼類型的產品,之前該人群的成長潛力如何。
I'm asking this because now (inaudible) will come one line earlier.
我之所以問這個問題,是因為現在(聽不清楚)會早一行。
I was wondering how fair to assume some patients will go through ADC sequencing, so Enhertu followed by Datroway.
我想知道如何公平地假設一些患者將經歷 ADC 測序,因此 Enhertu 隨後是 Datroway。
And the second question on baxdrostat, not in hypertension but in primary aldosteronism.
第二個問題是關於 baxdrostat 的,不是關於高血壓而是關於原發性醛固酮增多症。
How big do you think this opportunity is for the drug?
您認為這種藥物的機會有多大?
I mean there is potentially Phase 2 coming soon.
我的意思是第二階段可能很快就會到來。
So I was wondering what type of patients would benefit from baxdrostat in that indication?
所以我想知道哪種類型的患者會從 baxdrostat 中受益?
Thank you.
謝謝。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
So Dave, did you get it?
那麼戴夫,你明白了嗎?
Yes, okay.
是的,好的。
Good.
好的。
Because the line is not very, very good.
因為線路不是非常非常好。
David Fredrickson - Executive Vice President - Oncology Business Unit
David Fredrickson - Executive Vice President - Oncology Business Unit
Gonzalo, I'm pretty sure that you're asking basically a [TB-01] market size and market opportunity question.
貢薩洛,我很確定你基本上是在問[TB-01]市場規模和市場機會的問題。
So if that's not the question you're asking, I'm going to answer that anyway.
所以如果這不是你要問的問題,我無論如何都會回答。
(laughter) The -- so as we take a look at this, I mean, I think that what we're certainly seeing here is that the size of the market, G7, about 35,000 fourth plus line hormone receptor positive HER2-negative patients, right?
(笑聲)—所以當我們看一下這個時,我的意思是,我認為我們在這裡肯定看到的是市場規模,G7,大約有 35,000 名第四線以上激素受體陽性 HER2 陰性患者,對嗎?
So that's the patient population that we're talking about here that's addressable.
這就是我們在這裡談論的可解決的患者群體。
And so it's after ET, after chemotherapy.
這是 ET 之後,化療之後的情況。
And I think TB-01 really complements DB04, which is transforming the HER2 landscape, right?
我認為 TB-01 確實對 DB04 起到了補充作用,它正在改變 HER2 的格局,對嗎?
So the first part of this is that now with TB-01 at the lowest IHC scores, you've got an option to be able to treat with TB-01.
因此,第一部分是,現在 TB-01 的 IHC 評分最低,您可以選擇使用 TB-01 進行治療。
But then as DB06 starts to expand into the earlier treatment segment, there's a portion of the population also that, in later lines, will have seen in ET and a chemotherapy in the form of an ADC that could also be considered for utilization here.
但隨著 DB06 開始擴展到早期治療領域,也有一部分族群在後期會看到 ET 和以 ADC 形式進行的化療,這也可以考慮在這裡使用。
So I think that you've got an opportunity, particularly in the [null] space and then also potentially in the HER2 low space, but HER2 low more likely being kind of after they've seen an ADC upfront.
因此我認為你有機會,特別是在 [null] 空間,然後也可能在 HER2 低空間,但 HER2 低更有可能是在他們預先看到 ADC 之後。
And I just would lastly say, all of this is part of a strategy in breast cancer to really make sure that there's an option for all patients presenting, right?
最後我想說,這一切都是乳癌治療策略的一部分,目的是為了確保所有患者都有治療選擇,對嗎?
The camizestrant to replace backbone ET, Truqap to continue to have an opportunity in patients who can benefit from ER drive, multiple ADCs to replace chemotherapies within the space.
卡馬西平可取代骨幹 ET,Truqap 可繼續為受益於 ER 驅動的患者提供機會,多種 ADC 可取代該領域的化療。
And it's a comprehensive breast program that we've put together.
這是我們制定的一項全面性乳房保健計劃。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thanks, Dave.
謝謝,戴夫。
Ruud?
魯德?
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit
Yes.
是的。
Let me take the second one.
讓我選第二個。
So this is a very difficult area in that sense it is highly underdiagnosed.
因此,這是一個非常困難的領域,因為其診斷嚴重不足。
The expectation is that 5% to 8% of patients suffering from hypertension have this disease.
預計5%至8%的高血壓患者患有此病。
The reason we are so excited about it is that physicians came proactively to us to do study in this patient population because there's an incredible high unmet medical need.
我們對此感到非常興奮,原因是醫生們主動找到我們,對該患者群體進行研究,因為該群體的醫療需求存在著巨大的未滿足需求。
So once again, it's a ballpark figure, 5% to 8% of the anti-hypertensive -- of the hypertensive patients are suffering from this disease.
再次重申,這是一個大概的數字,5%到8%的高血壓患者患有這種疾病。
Pascal Soriot - Chief Executive Officer, Executive Director
Pascal Soriot - Chief Executive Officer, Executive Director
Thank you.
謝謝。
So let me thank you all for your great questions and your interest in our company and wish you a good rest of the day.
因此,我感謝大家提出的精彩問題以及對我們公司的興趣,並祝大家今天過得愉快。
Thank you very much.
非常感謝。