輝瑞 (Pfizer) 報告稱,在 COVID-19 和非 COVID 產品收入成長的推動下,2024 年第一季財務業績強勁。該公司專注於關鍵產品、成本管理以及透過資本配置策略提高股東價值。
輝瑞上調了全年收入指引,並討論了未來成長計劃,包括有前景的管道資產。他們致力於執行五點計劃,並與股東合作解決問題並調整期望。
輝瑞仍然專注於在製藥業提供價值和創新。
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
(Operator Instructions) Good day, everyone, and welcome to Pfizer's third-quarter 2024 earnings conference call.
(操作員說明)大家好,歡迎參加輝瑞 2024 年第三季財報電話會議。
Today's call is being recorded.
今天的通話正在錄音。
At this time, I would like to turn the call over to Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President.
現在,我想將電話轉給首席投資者關係長兼高級副總裁 Francesca DeMartino。
Please go ahead, ma'am.
請繼續,女士。
Francesca DeMartino - Chief Investor Relations Officer, Senior Vice President
Francesca DeMartino - Chief Investor Relations Officer, Senior Vice President
Good morning, and welcome to Pfizer's earnings call.
早安,歡迎參加輝瑞的財報電話會議。
I'm Francesca DeMartino, Chief Investor Relations Officer.
我是首席投資者關係官 Francesca DeMartino。
On behalf of the Pfizer team, thank you for joining us.
我謹代表輝瑞團隊感謝您加入我們。
This call is being made available via audio webcast at pfizer.com. Earlier this morning, we released our results for the third quarter of 2024 via a press release that is available on our website at pfizer.com.
此次電話會議透過 pfizer.com 上的音訊網路廣播進行。今天早些時候,我們透過新聞稿發布了 2024 年第三季的業績,該新聞稿可在我們的網站 pfizer.com 上取得。
I'm joined today by Dr. Albert Bourla, our Chairman and CEO; and Dave Denton, our CFO.
今天我們的董事長兼執行長 Albert Bourla 博士也加入了我的行列。以及我們的財務長戴夫丹頓 (Dave Denton)。
Albert and Dave have some prepared remarks, and we will then open the call for questions.
艾伯特和戴夫準備了一些發言,然後我們將開始提問。
Members of our leadership team will be available for the Q&A session, including Dr. Andrew Baum, who recently joined Pfizer as EVP and Chief Strategy and Innovation Officer.
我們的領導團隊成員將參加問答環節,包括最近加入輝瑞擔任執行副總裁兼首席策略和創新官的安德魯·鮑姆博士。
Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures.
在開始之前,我想提醒您,我們將做出前瞻性陳述並討論某些非公認會計準則財務指標。
I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on our IR website on pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.
我鼓勵您閱讀我們幻燈片演示中的免責聲明、我們今天早上發布的新聞稿以及我們 SEC 文件中的披露內容,這些都可以在我們的 IR 網站 pfizer.com 上找到。電話會議中的前瞻性陳述存在重大風險和不確定性,僅在電話會議原始日期發表,我們不承擔更新或修改任何陳述的義務。
With that, I will turn the call over to Albert.
這樣,我會將電話轉給艾伯特。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Francesca.
謝謝你,弗朗西斯卡。
Good morning, everyone.
大家早安。
Thank you for joining us today.
感謝您今天加入我們。
Our team continues to execute, and we are pleased to report another quarter of strong performance.
我們的團隊繼續執行,我們很高興地報告另一個季度的強勁業績。
We are guided by our purpose of delivering breakthroughs that change patients' lives, and I'm proud that we have reached more than 270 million patients with our medicines and vaccines through the first nine months of 2024.
我們的目標是實現改變患者生活的突破,到 2024 年前 9 個月,我們已經為超過 2.7 億患者提供了我們的藥物和疫苗,對此我感到非常自豪。
The focus on execution excellence is starting to deliver results, with market share gains in the US and international, as well as robust growth in revenues and EPS.
對卓越執行的關注開始取得成果,美國和國際市場份額不斷增加,營收和每股盈餘也強勁成長。
As a result, we are raising guidance ranges for our full-year 2024 total revenues and adjusted diluted earnings per share.
因此,我們提高了 2024 年全年總收入和調整後稀釋每股收益的指導範圍。
In January, we presented the five key priorities that would guide Pfizer during our year of execution.
一月份,我們提出了在我們的執行年中指導輝瑞的五個關鍵優先事項。
Today, you will hear how we advanced our business in the third quarter with each of these strategic priorities.
今天,您將聽到我們如何在第三季透過這些策略重點來推進我們的業務。
I will focus on highlighting -- showing our progress with the first three.
我將重點放在——展示我們在前三項方面取得的進展。
Dave will discuss our continued work to reduce our cost base, expand our margins, and strategically deploy our capital.
戴夫將討論我們為降低成本基礎、擴大利潤和策略性部署資本而持續進行的工作。
Then we will review our financial performance during the quarter and explain why we believe we are well-positioned to deliver on our financial commitments and create long-term value for shareholders.
然後我們將回顧本季的財務業績,並解釋為什麼我們相信我們有能力履行我們的財務承諾並為股東創造長期價值。
And then we will take questions.
然後我們將回答問題。
So with that, I'll turn to our performance against our priorities during the quarter.
因此,我將根據本季的優先事項來談談我們的業績。
Stated simply, oncology is having a great year and delivered another quarter of strong performance, with 31% year-over-year performance growth resulting from solid demand across our product portfolio that includes legacy Seagen and legacy Pfizer products.
簡而言之,腫瘤學領域度過了美好的一年,並在另一個季度實現了強勁的業績,由於我們的產品組合(包括傳統的Seagen 和傳統的輝瑞產品)的強勁需求,業績同比增長了31%。
We set a goal to achieve world-class oncology leaders.
我們設定的目標是成為世界級的腫瘤學領導者。
In the US, we are already the third largest biopharma company in oncology by revenue through the first half of 2024, and we are proud of the progress we are making toward our goal.
在美國,截至 2024 年上半年,以收入計算,我們已經成為腫瘤學領域第三大生物製藥公司,我們為實現目標所取得的進展感到自豪。
Demand continued to increase for XTANDI, the market leader for four types of advanced prostate cancer, grew 28% year over year.
作為四種晚期前列腺癌的市場領導者,XTANDI 的需求持續成長,年成長 28%。
TALZENNA grew by 77% in the quarter versus the same quarter from a year ago.
TALZENNA 本季與去年同期相比成長了 77%。
We are encouraged by the opportunity to further advance the prostate cancer treatment landscape based on the exciting overall survival data We announced earlier this month from the Phase III TALAPRO study.
我們對基於本月早些時候公佈的 III 期 TALAPRO 研究令人興奮的總體生存數據進一步推進前列腺癌治療前景的機會感到鼓舞。
In the study, TALZENNA in combination with XTANDI demonstrated statistically significant overall survival benefit in patients with metastatic castration-resistant prostate cancer, becoming the first and only such combination to do so.
在這項研究中,TALZENNA 與 XTANDI 聯合治療對轉移性去勢抵抗性前列腺癌患者顯示出具有統計意義的總體生存獲益,成為第一個也是唯一一個這樣做的聯合治療。
Driving scientific breakthroughs in genitourinary cancers is one of the key areas of focus in oncology.
推動泌尿生殖系統癌症的科學突破是腫瘤學的重點領域之一。
The TALAPRO-2 results show how we continue innovating to improve survival for men with prostate cancer, which is the second most common cancer in men and the fifth most common cause of cancer death among men worldwide.
TALAPRO-2 結果展示了我們如何繼續創新以提高前列腺癌男性的生存率,前列腺癌是男性第二大常見癌症,也是全球男性第五大常見癌症死亡原因。
We saw continued momentum during the quarter with the ongoing launch of PADCEV with pembrolizumab for patients with advanced metastatic bladder cancer, regardless of their eligibility to receive cisplatin-based chemotherapy.
我們在本季看到了持續的勢頭,針對晚期轉移性膀胱癌患者持續推出 PADCEV 聯合派姆單抗,無論他們是否有資格接受基於順鉑的化療。
This combination has quickly become the most prescribed first-line treatment in the US for locally advanced metastatic urothelial cancer.
此組合已迅速成為美國局部晚期轉移性尿路上皮癌最常使用的第一線治療方法。
In thoracic cancer, we achieved 31% operational growth this quarter with LORBRENA, a treatment for adults with ALK-positive metastatic non-small cell lung cancer.
在胸癌方面,我們本季透過 LORBRENA 實現了 31% 的營運成長,LORBRENA 是一種治療 ALK 陽性轉移性非小細胞肺癌成人的藥物。
Following the release of our five years of CROWN data during the ASCO annual meeting, we are observing an acceleration of first-line new patient starts around the world, and in particular, in our key markets of the US, China, Germany, and France.
繼在 ASCO 年會上發布五年 CROWN 資料後,我們觀察到全球第一線新病患開始加速,特別是在美國、中國、德國和法國等主要市場。
Our BRAFTOVI and MEKTOVI combination also achieved strong year-over-year growth in the third quarter of 32%, primarily driven by growth in the metastatic non-small cell cancer indication.
我們的 BRAFTOVI 和 MEKTOVI 組合在第三季度也實現了 32% 的強勁同比增長,這主要是由轉移性非小細胞癌適應症的增長推動的。
And we continue to be pleased by strong performance with the launch of ELREXFIO, which had about 80% sequential revenue growth over the second quarter of 2024.
我們仍然對 ELREXFIO 的強勁表現感到高興,該產品比 2024 年第二季的營收季增了約 80%。
In the US, we have more than doubled our new patient start since January.
在美國,自一月以來,我們的新患者數量增加了一倍以上。
In Japan, we were able to catch up with competition and launch as the first to market PCMA by specific, helping to address an unmet medical need for patients with triple-class exposed multiple myeloma.
在日本,我們能夠趕上競爭並率先推出特定的 PCMA,幫助解決三級暴露多發性骨髓瘤患者未滿足的醫療需求。
We believe ELREXFIO has the potential to be a transformative treatment option for people with multiple myeloma, and we are continuing to advance development with four ongoing registrational studies in earlier lines of therapy that, if positive and approved, could support serving a way more expanded patient population.
我們相信ELREXFIO 有潛力成為多發性骨髓瘤患者的變革性治療選擇,並且我們正在繼續推進早期療法中四項正在進行的註冊研究的開發,如果這些研究結果積極並獲得批准,可以支持為更廣泛的患者提供服務人口。
Now I will turn to some select highlights of how we continue strategically advancing our pipeline.
現在我將談談我們如何繼續策略性地推進我們的產品線的一些精選亮點。
We are prioritizing opportunities where we have scientific leadership and deep capabilities to address significant unmet patient needs.
我們正在優先考慮擁有科學領導力和深厚能力的機會,以解決未滿足的重大患者需求。
Earlier, I spoke to the strength of our market in oncology medicines.
早些時候,我談到了我們腫瘤藥物市場的實力。
Our pipeline, however, is what excites us the most.
然而,我們的管道才是最令我們興奮的。
Lung cancer is the number-one cause of cancer-related death around the world.
肺癌是全世界癌症相關死亡的第一大原因。
At the recent ESMA Congress, we saw long-term follow-up results from FOREST trial evaluating BRAFTOVI and MEKTOVI in patients with BRAF V600E mutant metastatic non-small cell lung cancer, which demonstrated compelling efficacy for patients.
在最近的ESMA 大會上,我們看到了FOREST 試驗的長期追蹤結果,該試驗評估了BRAFTOVI 和MEKTOVI 對BRAF V600E 突變型轉移性非小細胞肺癌患者的療效,該試驗對患者顯示出引人注目的療效。
We are also rapidly advancing to next-generation ADC candidates with the potential to make significant impact on the more than 300,000 patients with non-small cell lung cancer in the US.
我們也正在快速開發下一代 ADC 候選藥物,有可能對美國超過 30 萬名非小細胞肺癌患者產生重大影響。
The first is sigvotatug vedotin, which is now in Phase 3, and we are planning additional pivotal trials in the coming months.
第一個是 sigvotatug vedotin,目前處於第三階段,我們計劃在未來幾個月內進行更多關鍵試驗。
The other one is a PDL1-AV-ADC.
另一種是 PDL1-AV-ADC。
We are equally encouraged by the updated Phase I data we presented at ESMO for this ADC, and we are planning registration-enabling trials in 2025.
我們在 ESMO 上提交的該 ADC 的第一期更新資料同樣令我們感到鼓舞,我們計劃在 2025 年進行註冊試驗。
Our genitourinary pipeline is expanding.
我們的泌尿生殖管道正在擴大。
We are studying another novel ADC, disitamab vedotin, in two ongoing registration-intent trials in urothelial cancer.
我們正在兩項正在進行的尿路上皮癌註冊意向試驗中研究另一種新型 ADC,disitamab vedotin。
And mevrometostat, our novel EZH2 inhibitor, is another example of the progress we are making throughout our pipeline.
我們的新型 EZH2 抑制劑 mevrometostat 是我們在整個管道中取得進展的另一個例子。
This has been studied as a new potential treatment for men who have metastatic castration-resistant prostate cancer, and we are enrolling currently patients into Phase 3 studies.
這已被研究為患有轉移性去勢抵抗性前列腺癌的男性的一種新的潛在治療方法,我們目前正在將患者納入第 3 期研究。
Finally, to build on the foundation for our drugs, we are making progress with development of two candidates we believe can replace the current backbones of ER-positive HER2-negative breast cancer.
最後,為了奠定我們藥物的基礎,我們正在開發兩種候選藥物,我們相信它們可以取代目前 ER 陽性 HER2 陰性乳癌的主要藥物。
Atirmociclib, our potential first-in-class CDK4 inhibitor, is enrolling a second-line Phase 3 trial, and we expect to start a first-line Phase III study by early 2025.
Atirmociclib 是我們潛在的一流 CDK4 抑制劑,正在招募二線 3 期試驗,我們預計在 2025 年初啟動一線 3 期研究。
And we expect the first Phase III data in the coming months for vepdegestrant, estrogen receptor degrader that we are co-developing right now with Arvinas.
我們預計未來幾個月將獲得我們目前與 Arvinas 共同開發的雌激素受體降解劑 vepdegestrant 的第一個 III 期數據。
Our fourth-generation PCV candidate, now in Phase 2 adults and pediatrics, covers 25 serotypes, including improved immunogenicity for serotype 3, very important, which is one of the largest remaining contributors of disease.
我們的第四代 PCV 候選藥物目前正處於成人和兒科第 2 階段,涵蓋 25 种血清型,包括改善血清型 3 的免疫原性,這一點非常重要,它是剩餘的最大疾病貢獻者之一。
We are focused on building on our leadership in the industry by continuing to expand balance sheet with our fifth-generation candidate, which is in pre-clinical development that covers over 30 serotypes.
我們致力於透過持續擴大第五代候選藥物的資產負債表來鞏固我們在業界的領導地位,該候選藥物正處於臨床前開發階段,涵蓋 30 多种血清型。
In the last several months, we have advanced a potential new vaccine against C. diff, which is considered an urgent public health threat that lacks any approved vaccines.
在過去的幾個月裡,我們開發了一種針對艱難梭菌的潛在新疫苗,被認為是緊急的公共衛生威脅,但目前還沒有任何批准的疫苗。
Leveraging experience from our previous C. diff program, we have developed a new formulation for a second-generation candidate.
利用我們先前的 C. diff 專案的經驗,我們為第二代候選者開發了一種新配方。
After encouraging Phase I data with this new formulation, we have advanced to our Phase 2 study already.
在利用這個新配方獲得第一階段資料後,我們已經進入第二階段研究。
We are also working to support significant needs for about 90 million Americans and 200 million Europeans in areas with high incidence of Lyme disease.
我們也致力於滿足萊姆病高發生地區約 9,000 萬美國人和 2 億歐洲人的龐大需求。
VLA15 is a vaccine candidate we are co-developing that is intended to protect against the six most prevalent serotypes in North America and Europe.
VLA15 是我們正在共同開發的候選疫苗,旨在預防北美和歐洲六種最受歡迎的血清型。
A Phase 3 trial is underway.
第三階段試驗正在進行中。
And pending positive data and regulatory approval, VLA15 would become the only vaccine available to help prevent the acute, severe, and long-term health consequences of Lyme disease globally.
在獲得積極數據和監管部門批准之前,VLA15 將成為唯一可用於幫助預防全球萊姆病急性、嚴重和長期健康後果的疫苗。
Paxlovid is the standard of care COVID-19 oral treatment for those at high risk of progressing to severe disease.
Paxlovid 是針對那些進展為嚴重疾病的高風險族群的 COVID-19 口服治療標準。
We believe, however, that it is an opportunity to expand both our therapeutic impact and market position with our next-generation oral antiviral candidate, ibuzatrelvir.
然而,我們相信,這是一個擴大我們的下一代口服抗病毒候選藥物 ibuzatrelvir 的治療影響和市場地位的機會。
In a Phase 2 study, we have demonstrated robust antiviral activity at all doses and without the need for ritonavir boosting.
在一項 2 期研究中,我們證明了所有劑量的強大抗病毒活性,並且無需利托那韋加強。
We have addressed the drug-drug interactions and the metallic taste associated with Paxlovid.
我們已經解決了與 Paxlovid 相關的藥物間相互作用和金屬味。
We expect to start a Phase 3 study in the coming months.
我們預計在未來幾個月內開始第三階段研究。
We are also moving forward with our Phase 3 program in non-segmental vitiligo with ritlecitinib, a candidate with a differentiated JAK/STAT mechanism developed in-house at Pfizer that has the potential to be an expansion of indications for LITFULO, which is currently approved in severe alopecia areata.
我們也正在推進 Ritlecitinib 治療非節段性白斑症的 3 期項目,Ritlecitinib 是一種具有輝瑞內部開發的差異化 JAK/STAT 機制的候選藥物,有可能擴大 LITFULO 的適應症,目前該藥物已獲得批准在嚴重的斑禿中。
Vitiligo, like alopecia areata, is an autoimmune disease with high unmet need.
白斑症與斑禿一樣,是一種自體免疫疾病,其需求未被滿足。
It is the leading cause for skin depigmentation and affects nearly 3 million patients in the US alone.
它是皮膚色素脫失的主要原因,光在美國就有近 300 萬患者受到影響。
We are also enthusiastic about our two first-in-class trial-specific antibodies with early data demonstrating excellent 3-in-1 patterns.
我們也對我們的兩種一流的試驗特異性抗體充滿熱情,早期數據顯示出出色的三合一模式。
We believe this program has the potential to deliver improved efficacy in atopic dermatitis with an ongoing Phase 2 study evaluating safety and efficacy.
我們相信,透過正在進行的評估安全性和有效性的 2 期研究,該計劃有可能提高異位性皮膚炎的療效。
We had a Phase 2 redoubt of ponsegromab, which is another in-house discovery and development asset.
我們有 ponsegromab 的二期堡壘,這是另一個內部發現和開發資產。
We are encouraged by the potential for a breakthrough for patients with cancer or cachexia who lack treatment options for this life-threatening, wasting condition that currently has no FDA-approved treatment.
我們對癌症或惡病質患者的突破潛力感到鼓舞,這些患者缺乏針對這種危及生命的消耗性疾病的治療選擇,而目前尚無 FDA 批准的治療方法。
The Phase2I study met its primary endpoint of change from baseline in body weight compared to placebo across all doses tested.
2I 期研究在所有測試劑量中均達到了與安慰劑相比體重較基線變化的主要終點。
And at the highest dose evaluated, saw improvements for baseline in appetite, cachexia symptoms, physical activity, and muscle mass.
在評估的最高劑量下,食慾、惡病質症狀、體力活動和肌肉質量的基線有所改善。
Based on these positive results, we expect to advance to a registration-enabling study next year.
基於這些積極的結果,我們預計明年將推進註冊研究。
Our Phase 2 study in patients with heart failure-related cachexia is ongoing.
我們針對心臟衰竭相關惡病質患者的第二期研究正在進行中。
We remain on track with our dose optimization studies for danuglipron, our oral GLP-1 receptor agonist candidate, and look forward to discussing more about this in early 2025.
我們仍在對口服 GLP-1 受體激動劑候選藥物 danuglipron 進行劑量優化研究,並期待在 2025 年初對此進行更多討論。
In our broader obesity portfolio, we continue to advance our early-stage candidates, including our oral small-molecule GIPR antagonist, which is advancing to Phase 2 in 2024 this year, and an additional once-daily oral GLP-1 receptor agonist in Phase I.
在我們更廣泛的肥胖產品組合中,我們繼續推進我們的早期候選藥物,包括我們的口服小分子GIPR 拮抗劑,該拮抗劑將於今年2024 年進入2 期,以及另一種每天一次的口服GLP -1 受體激動劑。
The highlights I've mentioned today across important therapeutic areas show how we have made meaningful advancements with our pipeline.
我今天在重要治療領域提到的亮點表明我們如何在管道方面取得有意義的進展。
As we announced earlier this year, Dr. Mikael Dolsten, Pfizer's Chief Scientific Officer, will depart from Pfizer after 15 years of leading Pfizer's research efforts.
正如我們今年稍早宣布的那樣,輝瑞首席科學官 Mikael Dolsten 博士在領導輝瑞研究工作 15 年後將離開輝瑞。
Our progress for selecting a successor is now quite advanced, and we look forward to announcing an update soon.
我們選擇繼任者的進展現已相當順利,我們期待盡快宣布更新。
Now I will turn to our commercial performance.
現在我要談談我們的商業表演。
Another one of our strategic priorities is maximizing the performance of our new products.
我們的另一個策略重點是最大限度地提高新產品的效能。
I am pleased that the decisive actions we took to enhance our commercial organization at the beginning of the year are yielding satisfactory results.
我很高興我們年初為加強商業組織而採取的果斷行動正在取得令人滿意的結果。
With NURTEC, we saw 28% total prescription growth and continued leadership in the oral CGRP class.
借助 NURTEC,我們的總處方增加了 28%,並在口服 CGRP 類別中繼續保持領先地位。
Importantly, 85% of primary care clinicians writing CGRP prescriptions for the first time choose Nurtec.
重要的是,85% 首次開立 CGRP 處方的初級保健臨床醫生選擇 Nurtec。
This shows the progress we are making in primary care as well as our work with payers to remove barriers for timely patient access to treatment.
這表明我們在初級保健方面取得的進展,以及我們與付款人合作消除患者及時獲得治療的障礙。
Among our vaccines, we are very pleased with our performance since the launch of Prevnar20, which has already achieved 83% market share in pediatric and 97% in adults.
在我們的疫苗中,我們對 Prevnar20 上市以來的表現非常滿意,它已經在兒科和成人中取得了 83% 的市場份額和 97% 的市場份額。
With last week's recommendation by the Advisory Committee on Immunization Practices to expand adult pneumococcal vaccination to include all adults aged 50 and older.
免疫實踐諮詢委員會上周建議將成人肺炎球菌疫苗接種範圍擴大到所有 50 歲及以上的成年人。
We believe Prevnar20 is well positioned to serve an expanded population in the United States.
我們相信 Prevnar20 完全有能力為美國不斷擴大的人口提供服務。
Outside of the US, we are predominantly serving the pediatric market and following the recent first quarter approval in Japan and the EU, we are gaining vaccine technical committee recommendations and several market introductions.
在美國以外,我們主要服務於兒科市場,繼最近在日本和歐盟第一季獲得批准後,我們正在獲得疫苗技術委員會的建議和多個市場的推介。
With ABRYSVO, we continued improving our US market share position with strong commercial execution.
透過 ABRYSVO,我們憑藉強大的商業執行力繼續提高我們的美國市場份額地位。
Our market share of sales to retailers and clinics out of wholesalers has exceeded 50% for the quarter, and our market share of shots in arms in the retail setting has increased for nine consecutive weeks through mid-October, currently reaching 43%.
本季我們對零售商和診所的批發商銷售市佔率已超過 50%,截至 10 月中旬,我們在零售領域的市佔率已連續九週成長,目前達到 43%。
Last week's FDA approval for ABRYSVO for patients 18 through 59 who are at increased risk of low respiratory tract disease caused by RSV could help us serve an expanded population over time.
上週 FDA 批准 ABRYSVO 用於治療由 RSV 引起的下呼吸道疾病風險較高的 18 至 59 歲患者,這可能有助於我們隨著時間的推移為更多的人群提供服務。
With the rise in COVID-19 infection in the summer and early fall, we have responded to increased demand for Paxlovid as we launched in the US commercial market at the beginning of the year.
隨著夏季和初秋 COVID-19 感染的增加,我們在年初在美國商業市場推出了 Paxlovid,以應對不斷增長的需求。
Our better-than-expected growth during the quarter for Paxlovid reflects higher inflection rates and the strong commercial execution of our team.
Paxlovid 本季的成長優於預期,反映出更高的拐點率和我們團隊強大的商業執行力。
Our ability to execute effectively includes improving patient access, raising awareness of this treatment option, expanding use of alternative sides of care, and also continuing to educate healthcare providers.
我們有效執行的能力包括改善患者的可近性、提高對這種治療方案的認識、擴大替代護理的使用,以及繼續教育醫療保健提供者。
The demand for Paxlovid seems to have stabilized.
Paxlovid 的需求似乎已經穩定。
In the slide, you can see the total number of patients treated with Paxlovid in '24, which is very similar to the same period in '23.
在幻燈片中,您可以看到 24 年接受 Paxlovid 治療的患者總數,這與 23 年同期非常相似。
It appears to be closely correlated with its weight of COVID-19 that also appear to have very similar pattern in '23 and '24.
它似乎與 COVID-19 的權重密切相關,而 23 和 24 年的模式似乎也非常相似。
The 63% operational growth in the third quarter of our VYNDAQEL family of products is a direct result of our progress in expanding the healthcare provider base and supporting clinicians in identifying more patients who can benefit from this therapy, as well as our work to improve patient access and adherence to therapy.
我們的VYNDAQEL 系列產品第三季的營運成長了63%,這是我們在擴大醫療保健提供者基礎、支持臨床醫生識別更多可以從這種療法中受益的患者以及我們為改善患者狀況所做的工作方面取得進展的直接結果接受治療並堅持治療。
International VYNDAQEL is reimbursed in 44 markets right now, and more are expected next year.
國際 VYNDAQEL 目前在 44 個市場獲得報銷,預計明年將有更多市場報銷。
While diagnostic rates vary across markets, the unmet medical need remains significant, as illustrated by the 10% increase of patients on treatment in the third quarter versus the second quarter of 2024 in the US.
儘管不同市場的診斷率有所不同,但未滿足的醫療需求仍然很大,美國第三季度接受治療的患者數量較 2024 年第二季度增加了 10% 就表明了這一點。
We were pleased by the 74% quarterly operational growth and continued progress with expanding access with CIBINQO, a treatment for patients 12 and up with moderate to severe eczema who didn't respond to other treatments, and 27% growth in the US in the second to third quarters of 2024 with LITFULO, the first and only FDA-approved prescription pill for both adults and adolescents as young as 12 with severe alopecia areata.
我們對季度營運成長74% 以及CIBINQO 的使用範圍不斷擴大感到滿意,CIBINQO 是一種針對12 歲及以上對其他治療無反應的中度至重度濕疹患者的治療方法,第二季度在美國實現了27 % 的成長LITFULO 將於 2024 年第三季上市,這是第一個也是唯一一個 FDA 批准的處方藥,適用於成人和 12 歲以下患有嚴重斑禿的青少年。
And I will turn it over to Dave.
我會把它交給戴夫。
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
Thank you, Albert.
謝謝你,艾伯特。
And good morning, everyone.
大家早安。
I will build on Albert's comments by reinforcing that we are very pleased with the financial results for the third quarter of 2024.
我將在 Albert 的評論的基礎上強調我們對 2024 年第三季的財務業績非常滿意。
These results demonstrate that our focus and our execution against our five strategic priorities are driving positive patient outcomes and continued financial and operational strength.
這些結果表明,我們對五個策略重點的關注和執行正在推動積極的患者治療結果以及持續的財務和營運實力。
In addition to our strong top-line performance, our cost-reduction programs are creating a more efficient organization, setting the stage for increased capital returns and supporting our commitment to both maintaining and growing our dividend, all while enhancing shareholder value.
除了我們強勁的營收績效之外,我們的成本削減計畫還打造了一個更有效率的組織,為增加資本回報奠定了基礎,並支持我們維持和增加股利的承諾,同時提高了股東價值。
This morning, I will briefly review our Q3 P&L performance, I'll highlight our capital allocation priorities, and touch upon our full-year 2024 financial guidance.
今天早上,我將簡要回顧我們第三季的損益表現,重點介紹我們的資本配置優先事項,並談到我們的 2024 年全年財務指導。
Additionally, as we approach the end of the year, I will also share several modeling considerations as we begin to plan for 2025.
此外,隨著年底的臨近,我還將分享一些在我們開始規劃 2025 年時的建模注意事項。
Turning first to the third-quarter performance versus the same period of last year, let me walk down the P&L.
首先來看看第三季的業績與去年同期相比,讓我來看看損益表。
Total company revenues were $17.7 billion, representing an impressive 32% operational growth.
公司總收入達 177 億美元,營運成長高達 32%,令人印象深刻。
Our COVID-19 products were significant contributors, with Paxlovid generating $2.7 billion in revenue.
我們的 COVID-19 產品做出了重要貢獻,Paxlovid 創造了 27 億美元的收入。
This included $442 million related to delivering 1 million treatment courses to the US government strategic national stockpile.
其中包括與向美國政府戰略國家儲備提供 100 萬個療程相關的 4.42 億美元。
COMIRNATY, our COVID-19 vaccine, contributed $1.4 billion in revenue.
我們的 COVID-19 疫苗 COMIRNATY 貢獻了 14 億美元的收入。
Our COVID-19 products were not the only drivers during the quarter.
我們的 COVID-19 產品並不是本季唯一的推動因素。
Our non-COVID products also exhibited robust performance with revenues of $13.6 billion, reflecting 14% operational year-over-year growth.
我們的非新冠肺炎產品也表現強勁,營收達 136 億美元,營運年增 14%。
This performance shows that our refined commercial approach is working.
這一表現表明我們精緻的商業方法正在發揮作用。
We continue to focus on key products and geographies, we've refined how we allocate our commercial field resources globally, and we're further optimizing our marketing resources into key priority areas.
我們繼續專注於關鍵產品和地區,完善了全球商業領域資源的分配方式,並進一步將行銷資源優化到關鍵優先領域。
We saw a strong contribution from our recently acquired Seagen products, including PADCEV, which continues its momentum following the results of the EV302 study last year.
我們看到最近收購的 Seagen 產品做出了巨大貢獻,其中包括 PADCEV,繼去年 EV302 研究結果之後,該產品繼續保持強勁勢頭。
Other key growth drivers included VYNDAQEL, ELIQUIS, XTANDI, and NURTEC, partially offset by declines in Xeljanz and Ibrance.
其他主要成長動力包括 VYNDAQEL、ELIQUIS、XTANDI 和 NURTEC,但部分被 Xeljanz 和 Ibrance 的下滑所抵消。
Adjusted gross margin for the third quarter is approximately 72%, primarily the result of a net unfavorable mix related to our COVID-19 products, primarily due to the commodity profit split with BioNTech and applicable royalty expenses, as well as a slight dampening due to the associated costs incurred with the withdrawal of OXBRYTA.
第三季調整後毛利率約為 72%,主要是由於與我們的 COVID-19 產品相關的淨不利組合的結果,主要是由於與 BioNTech 的商品利潤分成和適用的特許權使用費,以及由於撤回OXBRYTA 所產生的相關費用。
All of this was partially offset by our ongoing focus on cost management across our manufacturing network.
所有這些都被我們持續關注整個製造網路的成本管理所部分抵消。
We continue to expect gross margins to be in the mid-70s for the full year, and as previously communicated, long-term improvements in gross margins will remain a key focus for the company over the next several years.
我們仍然預計全年毛利率將在 70 多歲左右,正如之前所傳達的,毛利率的長期改善仍將是公司未來幾年的重點。
We expect to achieve savings from Phase I of our manufacturing optimization program beginning in 2025 and deliver approximately $1.5 billion in savings for the first phase by the end of 2027.
我們預計從 2025 年開始,我們的製造優化計畫第一階段將實現節約,並在 2027 年底前為第一階段實現約 15 億美元的節約。
In parallel, we continue to evaluate our strategy for both Phase 2 and Phase 3, which will focus on network structure and product portfolio, respectively. and we expect to have more information to share on those components of the program once they become available.
同時,我們繼續評估第二階段和第三階段的策略,分別著重於網路結構和產品組合。我們希望在該計劃的這些組成部分推出後能夠分享更多資訊。
Total adjusted operating expenses decreased 2% operationally to $5.8 billion, and I will note that this amount includes spending acquired via our Seagen transaction.
調整後的營運支出總額下降了 2%,達到 58 億美元,我要指出的是,這筆金額包括透過我們的 Seagen 交易獲得的支出。
And looking at the components, adjusted SI&A expenses increased 1% operationally, driven primarily by marketing and promotional expenses for recently launched and acquired products, partially offset by a reduction in the US healthcare reform fees.
從組成部分來看,調整後的 SI&A 費用在營運上增加了 1%,這主要是由最近推出和收購的產品的營銷和促銷費用推動的,但部分被美國醫療改革費用的減少所抵消。
Adjusted R&D expenses decrease 4% operationally, driven primarily by lower spending on certain vaccine programs, as well as our cost realignment program, partially offset by an increase in spending related to the Seagen acquisition.
調整後的研發費用在營運上下降了 4%,這主要是由於某些疫苗項目的支出減少以及我們的成本調整計劃,但部分被與 Seagen 收購相關的支出增加所抵消。
We continue to be disciplined with our operational expense management and remain on track to deliver at least $4 billion in net cost savings from our cost realignment program by year end.
我們繼續嚴格營運費用管理,並預計在年底前透過成本調整計畫實現至少 40 億美元的淨成本節約。
Q3 reported diluted earnings per share was $0.78 per quarter, and our adjusted diluted earnings per share was $1.06, benefiting from our top-line performance and efficient operating structure as well as a favorable tax rate driven primarily by jurisdictional mix.
第三季的稀釋每股收益為每季0.78 美元,調整後的稀釋每股收益為1.06 美元,這得益於我們的營收業績、高效的營運結構以及主要由司法管轄區組合驅動的優惠稅率。
As mentioned last quarter, unique one-time items included in our GAAP results and excluded from our adjusted results this quarter include a $420 million charge related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program earlier this year.
如上季所提到的,我們的GAAP 業績包含但不包括在本季調整後業績中的獨特一次性項目包括與今年稍早終止我們的DMD 計畫導致的一項設施的預期銷售相關的4.2億美元費用。
Now let me quickly touch upon our capital allocation strategy, which is designed to enhance long-term shareholder value.
現在讓我快速談談我們的資本配置策略,該策略旨在提高長期股東價值。
Our strategy consists of both maintaining and growing our dividend over time, reinvesting in our business at an appropriate level of financial return, and making value-enhancing share repurchases after delivering our balance sheet.
我們的策略包括隨著時間的推移維持和增加股息,以適當的財務回報水平對我們的業務進行再投資,以及在交付資產負債表後進行增值股票回購。
In the first nine months of '24, we returned $7.1 billion to shareholders via our quarterly dividend, invested $7.8 billion in internal R&D, and as we expected, completed business development activity was minimal.
在 2024 年的前 9 個月,我們透過季度股息向股東返還了 71 億美元,在內部研發上投資了 78 億美元,正如我們預期的那樣,完成的業務開發活動很少。
Our commitment to delevering our capital structure to a gross leverage target of 3.25 times remains a key priority.
我們承諾將資本結構去槓桿化至總槓桿率目標為 3.25 倍,這仍然是我們的首要任務。
In support of that goal, year to date, we have delevered by approximately $4.4 billion, paying down approximately $2.3 billion in maturing debt and approximately $2.1 billion in commercial paper.
為了支持這一目標,今年迄今為止,我們已經去槓桿化了約 44 億美元,償還了約 23 億美元的到期債務和約 21 億美元的商業票據。
And in October, we monetized another tranche of our Haleon shares, which for reporting purposes is a Q4 event.
10 月份,我們將另一批 Haleon 股票貨幣化,出於報告目的,這是第四季度的事件。
We received approximately $3.5 billion in net cash proceeds, and our ownership in Haleon was reduced from approximately 23% to approximately 15%.
我們收到了大約 35 億美元的淨現金收益,我們在 Haleon 的所有權從大約 23% 減少到大約 15%。
Year to date, we have received approximately $6.9 billion of net cash proceeds from the sale of our shares.
今年迄今為止,我們透過出售股票獲得了約 69 億美元的淨現金收益。
We intend to monetize our remaining Haleon investment in a prudent fashion, considering our cash flow requirements and future market conditions.
考慮到我們的現金流需求和未來的市場狀況,我們打算以謹慎的方式將剩餘的 Haleon 投資貨幣化。
Overall, in Q3, we generate robust operating cash flows, which combined with the Haleon net sales proceeds of approximately $3.5 billion, resulting in a significant free cash flow generation as we enter the fourth quarter.
總體而言,在第三季度,我們產生了強勁的營運現金流,加上 Haleon 約 35 億美元的淨銷售收益,導致進入第四季時產生了大量的自由現金流。
Our objective remains to delever and return to a more balanced allocation of capital between reinvestment and direct return to shareholders over time.
我們的目標仍然是去槓桿化,並隨著時間的推移恢復再投資和直接回報股東之間更平衡的資本分配。
Now let me spend just a few minutes on our outlook for the full year.
現在讓我花幾分鐘談談我們對全年的展望。
Based on our focused execution and strong year-to-date results, we are raising our full-year '24 revenue guidance by $1.5 billion and our adjusted diluted earnings per share by $0.30. We now expect revenues in the range of $61 billion to $64 billion, and operational revenue growth excluding COVID-19 products is unchanged at 9% to 11% and takes into consideration reduction of sales associated with OXBRYTA.
基於我們專注的執行力和年初至今的強勁業績,我們將 24 年全年收入指引提高 15 億美元,並將調整後的稀釋每股收益提高 0.30 美元。我們現在預計收入在 610 億至 640 億美元之間,不包括 COVID-19 產品的營運收入成長保持在 9% 至 11% 不變,並考慮到 OXBRYTA 相關銷售額的減少。
COVID-19 product revenues are now expected to be $10.5 billion, $5 billion for COMIRNATY, and $5.5 billion for Paxlovid.
目前預計 COVID-19 產品收入為 105 億美元,COMIRNATY 為 50 億美元,Paxlovid 為 55 億美元。
Our guidance for adjusted SI&A, adjusted R&D, and our effective tax rate on adjusted income remains unchanged.
我們對調整後的 SI&A、調整後的研發以及調整後收入的有效稅率的指導保持不變。
And lastly, we expect adjusted diluted earnings per share of $2.75 to $2.95, primarily reflecting the top-line increase and absorbing the OXBRYTA impact.
最後,我們預計調整後攤薄每股收益為 2.75 美元至 2.95 美元,主要反映了營收成長並吸收了 OXBRYTA 的影響。
As a reminder, our EPS guidance includes an anticipated $0.40 of earnings dilution from the Seagen acquisition, largely due to financing costs.
提醒一下,我們的 EPS 指引包括預計因收購 Seagen 而導致的 0.40 美元的收益稀釋,這主要是由於融資成本造成的。
Now as we begin to look towards next year, I want to touch on a few modeling considerations.
現在,當我們開始展望明年時,我想談談一些建模注意事項。
As we've previously discussed, there are several non-recurring items included in our 2024 results.
正如我們之前討論的,我們 2024 年的業績中包含幾個非經常性項目。
First, during 2024, Paxlovid revenue included a US government revenue credit true-up and the fulfillment of our obligation to the US national strategic stockpile.
首先,2024 年期間,Paxlovid 的收入包括美國政府收入信貸調整和履行我們對美國國家戰略儲備的義務。
Second, given our ownership of Haleon is now below 20%, we will no longer record equity income from that investment in our adjusted earnings beginning in 2025.
其次,鑑於我們對 Haleon 的所有權目前低於 20%,從 2025 年開始,我們將不再在調整後收益中記錄該投資的股權收入。
And finally, our 2024 tax rate on adjusted income was favorably impacted by timing with respect to the impact of Pillar 2, and to a lesser extent, audit settlements.
最後,我們的 2024 年調整後所得稅率受到第二支柱影響的時機的有利影響,並在較小程度上受到審計和解的影響。
All in, these items are expected to have a favorable impact on full-year 2024 adjusted diluted earnings per share of approximately $0.30.
總而言之,這些項目預計將對 2024 年全年調整後稀釋每股盈餘產生約 0.30 美元的有利影響。
In closing, I'm extremely pleased with our third-quarter 2024 results and our overall performance this year.
最後,我對我們 2024 年第三季的業績和今年的整體表現非常滿意。
Our team remains dedicated to strong operational execution, and we believe our cost-saving programs will drive enhanced operating leverage over time that will enable us to consistently deliver on our financial commitments to our shareholders.
我們的團隊仍然致力於強大的營運執行力,我們相信,隨著時間的推移,我們的成本節約計劃將推動營運槓桿的提高,使我們能夠始終如一地履行對股東的財務承諾。
We are committed to driving long-term value creation through scientific leadership, portfolio strength, and productivity across all aspects of our business.
我們致力於透過業務各個方面的科學領導力、產品組合優勢和生產力來推動長期價值創造。
And with that, I'll now turn it back over to Albert.
現在,我將把它轉回給艾伯特。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thanks, Dave.
謝謝,戴夫。
It's time for the Q&A, but before we take our first question, I want to briefly address a topic that I know is in the minds of many.
現在是問答時間,但在我們提出第一個問題之前,我想簡要討論一個我知道很多人都關心的話題。
We seek to be attentive to our shareholders and are always open to hearing their perspective.
我們力求關注股東,並且始終樂於聽取他們的觀點。
We had a meeting with Starboard Value two weeks ago.
兩週前我們與 Starboard Value 舉行了一次會議。
I was there with our Lead Director and our Head of Investor Relations.
我和我們的首席董事以及投資者關係主管一起在那裡。
The meeting was constructive and cordial.
會議是建設性的、友善的。
They presented the same deck they made public last week.
他們展示了上周公開的同一套牌。
And given the proximity to our quarterly earnings day, we were mainly in listening mode.
鑑於臨近季度財報日,我們主要處於傾聽模式。
While we agree with some of the points they raised, we have vastly different views on many others.
雖然我們同意他們提出的一些觀點,但我們對其他許多觀點有截然不同的看法。
For example, they expressed dissatisfaction with our total shareholder return.
例如,他們對我們的股東總回報表示不滿。
We are not satisfied either, though we believe we are executing on the best path forward to increase shareholder value.
我們也不滿意,儘管我們相信我們正在走上增加股東價值的最佳道路。
On the other hand, they challenged our capital deployment for business development.
另一方面,他們對我們業務發展的資本配置提出了挑戰。
We believe that our deals will produce significant shareholder returns, and some of them, like Seagen or BioNTech, have been transformational for Pfizer.
我們相信,我們的交易將為股東帶來可觀的回報,其中一些交易,如 Seagen 或 BioNTech,已經為輝瑞帶來了變革。
The important thing is what we do to improve shareholders.
重要的是我們如何改善股東。
In January, we presented a five-point plan aiming to create shareholder value that has guided our decision-making all year long.
一月份,我們提出了旨在創造股東價值的五點計劃,該計劃指導了我們全年的決策。
We remain focused on executing this plan and on delivering for our commitments, including driving long-term shareholder value.
我們仍然專注於執行該計劃並兌現我們的承諾,包括推動長期股東價值。
We will engage productively with our shareholders, including Starboard, and will consider all good ideas that are offered.
我們將與包括 Starboard 在內的股東進行富有成效的合作,並將考慮所有提出的好想法。
And with that, operator, please assemble the queue to discuss our third-quarter performance and pipeline.
那麼,操作員,請召集隊列來討論我們第三季的業績和管道。
Operator
Operator
(Operator Instructions) Chris Shibutani, Goldman Sachs.
(操作員指令)Chris Shibutani,高盛。
Chris Shibutani - Analyst
Chris Shibutani - Analyst
Good morning and thank you very much.
早安,非常感謝。
I wanted to ask questions about the pipeline, in particular with regard to obesity, where we appreciate the additional insights into what you have in the clinic.
我想詢問有關管道的問題,特別是有關肥胖的問題,我們感謝您對診所的更多見解。
Albert, you previously said that you believe that Pfizer could be the number-two company on the market with an oral.
艾伯特,您之前說過,您相信輝瑞可能成為市場上口服藥物排名第二的公司。
That would imply that danuglipron is the lead asset there.
這意味著 Danuglipron 是那裡的主要資產。
However, you do have two additional assets that we find intriguing, a GLP-1 oral that is in 1Phase I that is once a day but would clearly be behind, and then now an oral GIPR antagonist, which I think is a source of debate.
然而,你確實有兩個我們覺得有趣的額外資產,一種處於第一階段的GLP-1 口服藥物,每天一次,但顯然會落後,然後現在是一種口服GIPR 拮抗劑,我認為這是一個爭論的根源。
Can you frame what your strategy is, how important it is to be second to market versus perhaps having a differentiated approach with these two assets?
您能否闡述您的策略是什麼? 緊接著市場的重要性與對這兩種資產採取差異化方法的重要性?
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Look, I will ask Mikael to comment because there is a lot of activities going on right now.
聽著,我會請 Mikael 發表評論,因為現在有很多活動正在進行。
But my general comment is that, as I have said, if danu moves fast, based on what we know right now, we should be the second oral into the market, provided that the first one will be successful and the other ones will not come before us.
但我的總體評論是,正如我所說,如果 Danu 行動迅速,根據我們目前所知,我們應該是第二個進入市場的公司,前提是第一個會成功,而其他的不會出現。我們面前。
But so far, this is what the situation looks like.
但到目前為止,情況就是這樣。
The market is very, very large, and there is a significant need for oral solution.
市場非常非常大,對口服溶液的需求很大。
We know that.
我們知道這一點。
So there is no doubt that if successful, we will have our decent market share over there.
因此,毫無疑問,如果成功,我們將在那裡擁有可觀的市場份額。
But the important thing is that the obesity market is developing, let's say nicely also in terms of science, and we are exploring several other opportunities right now.
但重要的是,肥胖市場正在發展,可以說在科學方面也很好,我們現在正在探索其他幾個機會。
The two that we have mentioned in the clinic, Mikael can speak a little bit more, both about the danu and the other two.
我們在診所中提到的兩個,Mikael 可以多說一點,既關於達努又關於另外兩個。
Mikael?
米凱爾?
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Thank you, Albert.
謝謝你,艾伯特。
Yes, as you heard in Albert's remarks before the meeting, we continue to execute on our danuglipron plan, which includes a once-a-day profile with a modified release type of system, and we do believe that once a day with modified release could have some really special features.
是的,正如您在阿爾伯特在會議前的演講中聽到的那樣,我們繼續執行我們的danuglipron 計劃,其中包括每天一次的配置文件和修改後的發布類型的系統,我們確實相信每天一次的修改後的發布可以有一些非常特別的功能。
And bringing that as a second oral would help really to have a strong foot into this market.
將其作為第二次口頭演講將真正有助於在這個市場上站穩腳跟。
In the same way, we have seen the injectable being split between two different products.
同樣,我們也看到注射劑被分成兩種不同的產品。
I don't expect that the various oral will in the end differ that much in the GLP-1 class.
我不認為不同的口服藥物最終在 GLP-1 類別中會有如此大的差異。
So that's why we were keen also to move a GIPR, which could add better probability and more efficacy.
這就是為什麼我們也熱衷於移動 GIPR,這可以增加更好的機率和更高的效率。
And we're right now initiating Phase II studies on the backbone of GLP agents.
我們現在正在啟動 GLP 藥物骨幹的第二階段研究。
And these are our two more advanced bets.
這是我們的兩個更高級的賭注。
Plus, we always like to bring in this huge segment in drugs and have more options as we advance.
另外,我們總是希望引入這一巨大的藥品領域,並隨著我們的進步有更多的選擇。
And you have heard there are so many applications for GLP-1s, and that's why we have a second once-a-day agent.
您聽說過 GLP-1 的應用如此之多,這就是為什麼我們有第二個每日一次的製劑。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Mikael.
謝謝你,米凱爾。
Next question, please.
請下一個問題。
Operator
Operator
Srikripa Devarakonda, Truist.
Srikripa Devarakonda,真理主義者。
Srikripa Devarakonda - Analyst
Srikripa Devarakonda - Analyst
Hey, guys.
嘿,夥計們。
Thank you so much for taking my question.
非常感謝您回答我的問題。
I have actually a question on your recent data from ponsegromab program in cachexia.
實際上,我對你們最近在惡病質中的 ponsegromab 程序的數據有一個疑問。
You reported positive filter data.
您報告了陽性過濾器數據。
And just broadly speaking, this program has been previously highlighted as well.
從廣義上講,該計劃之前也已被強調過。
For the registrational trials, would a trial that replicates your Phase 2 in a larger group of patients be sufficient?
對於註冊試驗,在更多患者群體中重複 2 期試驗是否足夠?
Or would you need to show outcomes like survival?
或者您需要展示諸如生存之類的結果嗎?
And also, as we await details of the registration trials, can you help us understand how big of an opportunity you see for this drug?
另外,當我們等待註冊試驗的詳細資訊時,您能否幫助我們了解您認為這種藥物的機會有多大?
Thank you so much.
太感謝了。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Let's start with Mikael a little bit on the science, and then maybe Andrew can speak about the potential market size of the cachexia.
讓我們先從米凱爾(Mikael)談起一些科學知識,然後安德魯也許可以談談惡病質的潛在市場規模。
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
I think, in general, for cancer agents, and this is more in the supportive care, we're addressing segments of unmet patient needs which relates to be able to regain performance status with better body weight, have higher physical activity, and be able to go through more treatment cycles, which should often translate to better long-term survival.
我認為,總的來說,對於癌症藥物,這更多的是在支持性護理中,我們正在解決未滿足的患者需求,這些需求涉及能夠以更好的體重恢復表現狀態,進行更高的體力活動,並能夠經歷更多的治療週期,這通常會轉化為更好的長期生存。
As you know, that is always dependent on how patients cross over to different trials.
如您所知,這始終取決於患者如何跨入不同的試驗。
So I do think initial registration will come from a similar endpoint as in our Phase 2 studies, but we clearly aim to translate that better patient performance to other outcomes that are more harder endpoints, going through more treatment cycles and treatments that correlate with better cancer outcomes over time.
因此,我確實認為初始註冊將來自與我們的2 期研究類似的終點,但我們的明確目標是將更好的患者表現轉化為更困難的終點的其他結果,經歷更多的治療週期和與更好的癌症相關的治療隨著時間的推移的結果。
And this will be shown in multiple cancer types, so we do think, similar to other products that earlier have been heavily used in supportive cancer care, this could be very a large opportunity.
這將在多種癌症類型中得到體現,因此我們確實認為,與早期廣泛用於支持性癌症護理的其他產品類似,這可能是一個非常大的機會。
And in addition to that, we are running heart failure studies and looking at a third opportunity, also large chronic disease.
除此之外,我們正在進行心臟衰竭研究,並尋找第三個機會,即大型慢性疾病。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And with that, Andrew, some comments on the potential of this molecule?
安德魯,關於這個分子的潛力有什麼評論嗎?
Andrew Baum - Chief Strategy and Innovation Officer, EVP
Andrew Baum - Chief Strategy and Innovation Officer, EVP
Yes.
是的。
Hello, Kripa.
你好,克里帕。
I'm building on Mikael's comments.
我以 Mikael 的評論為基礎。
Look, cachexia is a massive unmet medical need.
看,惡病質是一個巨大的未滿足的醫療需求。
It's 50% to 80% of patients with oncology suffer from it, particularly, as within pancreatic and non-small cell lung cancer.
50% 至 80% 的腫瘤患者患有此疾病,尤其是胰臟癌和非小細胞肺癌。
It's probably about 20% to 30% in heart failure and COPD.
心臟衰竭和慢性阻塞性肺病 (COPD) 的發生率可能約為 20% 至 30%。
The size of the market really depends on whether it's viewed as a supportive care therapy.
市場規模實際上取決於它是否被視為支持性護理療法。
But also, obviously, as Mikael mentioned, whether you have outcome benefit.
但顯然,正如米凱爾所提到的,你是否有結果效益。
And obviously, depending on the outcome of those trials, we're going to be looking at different price points.
顯然,根據這些試驗的結果,我們將考慮不同的價格點。
So the size of the market, or particularly the size of this drug, is going to be very much informed by the data that we deliver in the pending Phase 2 and Phase 3 trials.
因此,市場的規模,特別是這種藥物的規模,將在很大程度上取決於我們在即將進行的 2 期和 3 期試驗中提供的數據。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you.
謝謝。
Next question, please.
請下一個問題。
Operator
Operator
Umer Raffat, Evercore ISI.
烏默·拉法特,Evercore ISI。
Umer Raffat - Analyst
Umer Raffat - Analyst
Hi, guys.
嗨,大家好。
Thanks for taking my question.
感謝您提出我的問題。
I feel like it's still very early in your engagement with some of your shareholders and the new shareholders, so perhaps it might be too premature to ask much further on that.
我覺得您與一些股東和新股東的接觸還為時過早,所以現在進一步詢問這個問題可能還為時過早。
So instead, maybe I'll focus on pipeline briefly.
因此,也許我會簡單地關注管道。
I know you mentioned, Mikael, that the oral GIPR antagonist adds better tolerability and more efficacy.
我知道你提到過,Mikael,口服 GIPR 拮抗劑可以增加更好的耐受性和功效。
It sounded like you were implying it's more incremental to what an oral GLP could do as a standalone.
聽起來您的意思是,它比口服 GLP 作為獨立藥物可以做的事情更具增量性。
Could you just lay that into context?
你能把它放在上下文中嗎?
For example, in the four-week Phase 1 study you ran, did it hit 4% to 5% weight loss?
例如,在您進行的為期 4 週的第一階段研究中,體重減輕了 4% 到 5% 嗎?
And secondly, the more than 30-valent pneumococcal vaccine that you guys disclosed this morning, does it have more than one carrier protein?
第二,你們今天早上披露的30多價肺炎鏈球菌疫苗,是否有不只一種載體蛋白?
Thank you very much.
非常感謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Mikael?
米凱爾?
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Yes, I think the ability of GIPR to act in concert with GLP-1 has been well documented in a few different peptide settings, so we aim to be the first to document this with an oral approach, and that could offer a really nice differentiation for patients that need more and faster achieving of their treatment objectives.
是的,我認為GIPR 與GLP-1 協同作用的能力已在幾種不同的勝肽環境中得到充分記錄,因此我們的目標是成為第一個透過口服方法記錄這一點的人,這可以提供非常好的差異化適合需要更多更快實現治療目標的患者。
That's what we want to reveal right now.
這就是我們現在想要透露的內容。
Under our new platform for PCV generation four and five, we include a number of technical improvements.
在我們的第四代和第五代 PCV 新平台下,我們進行了多項技術改進。
We don't want to disclose those today, but we're open to mention that our PCV fourth generation, which covers 25 serotypes, have as an example an improved serotype 3 based on new technology that moves it far beyond what we believe any other technology has been able to accomplish.
今天我們不想透露這些,但我們願意提及我們的第四代 PCV,涵蓋 25 种血清型,例如基於新技術的改進血清型 3,該技術遠遠超出了我們認為的任何其他血清型技術已經能夠實現。
And why is that important?
為什麼這很重要?
Well, serotype 3 covers somewhere between 15% to 30% of disease in different countries.
在不同國家,血清型 3 涵蓋了 15% 至 30% 的疾病。
And improving on that can have a bigger impact than adding a number of rather infrequent serotypes.
與添加一些相當不常見的血清型相比,對此進行改進可以產生更大的影響。
As we go to the more than 30 valent, it will be a combination of such improvement and many more serotypes.
當我們達到 30 多個價時,它將是這種改進和更多血清型的結合。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Mikael.
謝謝你,米凱爾。
Next question, please.
請下一個問題。
Operator
Operator
Trung Huynh, UBS.
Trung Huynh,瑞銀。
Trung Huynh - Analyst
Trung Huynh - Analyst
Hi, guys.
嗨,大家好。
Sorry, I was on mute there.
抱歉,我當時處於靜音狀態。
Trung Huynh from UBS.
瑞銀 (UBS) 的 Trung Huynh。
Thanks for taking my questions.
感謝您回答我的問題。
I have two.
我有兩個。
So thanks very much for the comments on the activist investor.
非常感謝這位激進投資者的評論。
You said you disagreed with the thoughts over capital deployment and then you cited significant shareholder returns for Seagen and BioNTech.
您說您不同意關於資本部署的想法,然後您引用了 Seagen 和 BioNTech 的顯著股東回報。
What's the difference between what you're thinking and perhaps what the Street's thinking here on BD?
您的想法與 BD 上華爾街的想法有什麼不同?
And then how do you intend to restore that investor confidence back into the company so that bridge between your expectations and the Street can be aligned?
那麼您打算如何恢復投資者對公司的信心,以便您的期望與華爾街之間的橋樑保持一致?
And then just on your commitment to delevering, thanks for the comments on the prepared remarks here.
然後就您對去槓桿化的承諾,感謝您對此處準備好的評論的評論。
Is there an appetite to delever even quicker and sell the hospital business and fully divest the Haleon stake earlier?
是否有興趣更快地去槓桿化並出售醫院業務並提前完全剝離海倫股份?
You do have products going off with LOE soon.
你們的產品很快就會與 LOE 一起上市。
That could give you a little bit more flexibility on the balance sheet.
這可以為你的資產負債表帶來更多的彈性。
So yes, just thoughts here.
所以是的,這裡只是想法。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Why don't we start with this one, and then I'll take a little bit of the activist question.
我們為什麼不從這個開始,然後我會回答一些激進分子的問題。
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
Yes.
是的。
So first on the delevering point, yes, our objective is to delever as rapidly as possible, and I think the company's been laser focused on doing that, given the fact that we've taken out about $4.4 billion in debt year to date, and we'll continue to do that.
首先是去槓桿化問題,是的,我們的目標是盡快去槓桿化,我認為公司一直專注於做到這一點,因為我們今年迄今已償還了約 44 億美元的債務,並且我們將繼續這樣做。
Secondly, without speaking directly around any potential BD opportunities here, is we're always looking to evaluate the infrastructure that we have and the assets that we currently maintain and understand if there's availability to, I'll say, monetize some of those assets over time to further support our delevering activities.
其次,這裡不直接談論任何潛在的 BD 機會,我們總是在尋求評估我們擁有的基礎設施和我們當前維護的資產,並了解是否可以將其中一些資產貨幣化現在是進一步支持我們的去槓桿活動的時候了。
So I would say all options are on the table, and we'll continue to evaluate on what makes the most sense for us strategically long term.
因此,我想說,所有選擇都已擺在桌面上,我們將繼續評估對我們的長期策略最有意義的選擇。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
As regards to the -- our projections compared to the Street projections in the business development, first of all, let's start by saying that by far, the two biggest, it is Seagen and BioNTech in terms of revenues, right?
關於——我們的預測與華爾街對業務發展的預測相比,首先,我們首先要說的是,就收入而言,迄今為止最大的兩家是 Seagen 和 BioNTech,對吧?
And in both of that, I think the Street moved on Seagen way up compared to when we made the deal.
在這兩方面,我認為與我們達成交易時相比,華爾街對 Seagen 的關注度大幅上升。
And on COMIRNATY, we are very, very stable.
在 COMIRNATY 上,我們非常非常穩定。
The other ones that also, if you add to that the Biohaven with NURTEC, which we are on our plans and we just exceeded for the second quarter, straight expectations, it is covering 80% of the investment that we have made and probably way more in terms of revenues.
其他的,如果你加上 Biohaven 和 NURTEC,我們正在計劃中,而且我們剛剛在第二季度超出了直接預期,它覆蓋了我們已經進行的投資的 80%,甚至可能更多。
And the most important thing is that those Seagen, for example, or the BioNTech with our development of mRNA infrastructure around the world, and the Seagen acquisition with our taking over the ADC technology of it, which was a unique, unique asset, is transformational for Pfizer.
最重要的是,例如Seagen,或BioNTech,我們在全球開發了mRNA 基礎設施,以及我們收購了Seagen,我們接管了它的ADC 技術,這是一項獨特的、獨特的資產,是變革性的對於輝瑞。
It's not the revenue growth that we are seeing right now and will continue seeing all the way towards the end of the decade.
這不是我們現在看到的收入成長,並將在本十年末繼續看到。
But it is two ADCs, one already in Phase 3, the other is about to start Phase 3, that we got from Seagen, one the SV and the other the PDL-1 ADC.
但這是我們從 Seagen 獲得的兩個 ADC,一個已經處於第 3 階段,另一個即將開始第 3 階段,一個是 SV,另一個是 PDL-1 ADC。
Those are mega blockbusters if there are technical successes.
如果技術上取得成功,這些都是超級大片。
Mega blockbusters.
超級大片。
And we are moving to Phase3I because we have seen very positive earlier data.
我們正在進入第三階段,因為我們看到了非常積極的早期數據。
The same issue we are starting with in Disitamab vedotin in genitourinary cancer, another ADC.
我們在治療泌尿生殖系統癌症的 Disitamab vedotin(另一種 ADC)中也開始討論同樣的問題。
So I would say that I think we truly think that this was well invested capital and will demonstrate significant value for shareholders.
所以我想說,我認為我們確實認為這是一筆很好的投資,並將為股東帶來巨大的價值。
But I want also to make a final comment for any discussion with activists.
但我還想對與活動人士的任何討論發表最後評論。
But no matter if we agree or disagree on what has happened, I think the most important thing, it is what we are doing going forward.
但無論我們對所發生的事情是否同意,我認為最重要的是我們未來正在做的事情。
Starboard has not presented any specific actions, but they suggested something needs to change.
Starboard 尚未提出任何具體行動,但他們建議有些事情需要改變。
From that point, in the beginning of the year, already a year ago, we are already starting changing a lot of things.
從那時起,在今年年初,已經一年前,我們已經開始改變很多事情。
Over the past 10 months, we have implemented changes like we changed our commercial model to separate the US and international business and appointed new leaders who have now delivered three consecutive quarters of revenue and earnings.
在過去的 10 個月裡,我們實施了一些變革,例如改變了商業模式,將美國業務和國際業務分開,並任命了新的領導者,他們現在已經連續三個季度實現了收入和盈利。
We integrated Seagen and created an end-to-end oncology research organization to ensure a successful integration of the company, of the Seagen pipeline, and we have retained the vast majority of the legacy Seagen colleagues, and we have delivered multiple, multiple successful readouts from that.
我們整合了 Seagen 並創建了一個端到端腫瘤學研究組織,以確保公司和 Seagen 管道的成功整合,我們保留了絕大多數舊 Seagen 同事,並且我們已經交付了多個成功的讀數從那。
We announced a plan to reduce OpEx by $4 billion, which we are executing successfully without negatively affecting the top line.
我們宣布了一項將營運支出減少 40 億美元的計劃,我們正在成功執行該計劃,並且沒有對營收產生負面影響。
We announced an additional plan to reduce manufacturing costs by $1.5 billion, which so far is delivering satisfactory results.
我們宣布了一項額外計劃,將製造成本降低 15 億美元,到目前為止,該計劃取得了令人滿意的結果。
We brought in Andrew Baum, who is a knowledgeable research analyst to help prioritize our R&D pipeline and future business development.
我們聘請了知識淵博的研究分析師安德魯·鮑姆(Andrew Baum)來幫助確定我們的研發管道和未來業務發展的優先順序。
We are advancing now the process of selecting a new Scientific Officer.
我們現在正在推進選舉新科學官員的過程。
And we have enhanced our Board with two terrific new Directors who have deep expertise in corporate governance and stakeholder value creation.
我們也任命了兩位優秀的新董事來增強董事會實力,他們在公司治理和利害關係人價值創造方面擁有深厚的專業知識。
So what we believe is that all these changes are the result of an intentional five-point plan that we rolled out already in January of last year.
所以我們相信,所有這些變化都是我們去年一月推出的五點計畫的結果。
So as I said in my personal, let's say, remarks, we plan to engage with shareholders, including Starboard. and consider any good ideas that create long-term shareholder value.
正如我在個人言論中所說,我們計劃與包括 Starboard 在內的股東進行接觸。並考慮任何能夠創造長期股東價值的好主意。
But I don't think that the statement something needs to change is really pragmatic because it's coming 15 months later.
但我認為某些事情需要改變的聲明並不真正務實,因為它是在 15 個月後發布的。
Next question, please.
請下一個問題。
Operator
Operator
Louise Chen, Cantor.
路易絲·陳,康托爾。
Your line is open.
您的線路已開通。
Louise Chen - Analyst
Louise Chen - Analyst
Hi, thanks for taking my questions.
您好,感謝您回答我的問題。
So I just had two here.
所以我這裡只有兩個。
First one I wanted to ask you is how we should think about the big pushes and pulls for sales and EPS in 2025.
我想問的第一個問題是我們應該如何看待 2025 年銷售額和每股盈餘的巨大推動和拉動。
And when you might give guidance, could it be as early as this year?
什麼時候可以提供指導,最早可以在今年嗎?
And then second one, just on Seagen, just wondering how the integration is coming along and if you have any updates to some of the metrics that you gave like sales in 2030 and what have you for the Seagen deal.
然後是第二個,就 Seagen 而言,只是想知道整合進展如何,以及您提供的一些指標(例如 2030 年銷售額)是否有任何更新,以及 Seagen 交易有何進展。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Okay, Dave, let's start with the first question.
好的,戴夫,讓我們從第一個問題開始。
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
Yes, so thank you.
是的,所以謝謝你。
Regarding 2025 is really topical because we're in the middle, as you can imagine, building our 2025 financial plan here across all of our business lines.
關於 2025 年確實是一個熱門話題,因為正如您可以想像的那樣,我們正處於中間階段,正在製定我們所有業務線的 2025 年財務計劃。
To your point, there's going to be a lot of pushes and pulls as we think about growth into next year on both our core business as well as our COVID business.
就你的觀點而言,當我們考慮明年我們的核心業務和新冠業務的成長時,將會有很多推動和拉動。
It is our expectation that we will provide guidance for 2025, most likely by the end of this year.
我們預計將在 2025 年(最有可能在今年年底)提供指導。
So stay tuned, more to come.
所以請繼續關注,更多內容即將推出。
We will lay out all the pushes and pulls when we give guidance for 2025, so you can get a very clear understanding of our business and the opportunities to enhance shareholder value longer term.
當我們給出 2025 年指導時,我們將列出所有的推動因素和拉動因素,以便您可以非常清楚地了解我們的業務以及長期提高股東價值的機會。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Chris, can you give us an update on the Seagen integration?
Chris,您能為我們介紹一下 Seagen 整合的最新情況嗎?
Both, speak a little bit about the commercial, but also focus on the research, which is a significant value.
兩者都講一點商業性,但也注重研究,這是很有價值的。
Chris Boshoff - Chief Oncology Officer, EVP
Chris Boshoff - Chief Oncology Officer, EVP
Thank you very much for the question.
非常感謝你的提問。
Overall, we're very pleased with the integration to date.
總的來說,我們對迄今為止的整合非常滿意。
We've retained the vast majority of colleagues at legacy Seagen, and we now have over 1,500 colleagues working in our facilities in Bothell, just outside Seattle.
我們保留了舊 Seagen 的絕大多數同事,現在有 1,500 多名同事在位於西雅圖郊外博塞爾的工廠工作。
As you saw, the global revenue in Q3, we printed $854 million from legacy Segen, and of that, PADCEV printed over $400 million in Q3.
正如您所看到的,在第三季的全球收入中,我們從傳統 Segen 中印出了 8.54 億美元,其中 PADCEV 在第三季印出了超過 4 億美元。
Seagen, year to date, delivered for us $2.3 billion, which is 38% year over year on a pro forma basis.
Seagen 今年迄今已交付 23 億美元,按預計年增 38%。
We continue to execute very well on the portfolio, on the pipeline.
我們在產品組合和管道上繼續執行得很好。
We started Phase 3 studies with Disitamab vedotin in urothelial cancer, that's HER2 low, which is up to 40% of bladder cancer; with Sigvotatug vedotin, the differentiated B6A, started the first Phase III study in non-squamous, non-small cell lung cancer.
我們開始了 Disitamab vedotin 治療尿路上皮癌的 3 期研究,這種尿路上皮癌的 HER2 水平較低,高達 40% 的膀胱癌;與 Sigvotatug vedotin(分化的 B6A)一起,啟動了第一個針對非鱗狀非小細胞肺癌的 III 期研究。
That's where we saw the most significant data.
這就是我們看到最重要數據的地方。
And we're also planning to start a combination of Sigvotatug vedotin plus pembrolizumab in the first line setting of non-small cell lung cancer and recently discussed and aligned with the FDA on the trial design and on the dosing.
我們還計劃在非小細胞肺癌的一線治療中開始使用 Sigvotatug vedotin 和 pembrolizumab 的組合,並且最近與 FDA 就試驗設計和劑量進行了討論和協調。
We're also progressing and should start a Phase 3 program with the PD-L1V, vedotin and disi in combination with pembrolizumab early next year.
我們也在取得進展,應該在明年初啟動 PD-L1V、vedotin 和 disi 與 pembrolizumab 聯合的 3 期專案。
So overall, great commercial performance so far.
總的來說,到目前為止,商業表現出色。
We haven't missed a beat, and we continue to execute on the pipeline.
我們沒有錯過任何一個節拍,並且繼續在管道上執行。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Chris.
謝謝你,克里斯。
Next question, please.
請下一個問題。
Operator
Operator
Geoff Meacham, Citi.
花旗集團的傑夫‧米查姆。
Geoff Meacham - Analyst
Geoff Meacham - Analyst
Good morning, everyone.
大家早安。
Thanks so much for the question.
非常感謝您的提問。
Just had a couple of quick ones.
剛剛吃了幾個快速的。
Mikael, another one on obesity, and I know you've added assets outside of danuglipron and I appreciate that it's early.
Mikael,另一位關於肥胖的人,我知道你已經添加了 danuglipron 之外的資產,我很高興現在還為時過早。
I want to ask you, what does success look like on efficacy, just given the bar today?
我想問你,就今天的酒吧而言,成功的功效是什麼樣的?
And then strategically, how does Pfizer view orals versus longer-acting injectables when you think about the investments Pfizer is making in this category?
然後,從策略上講,當您考慮輝瑞在這一類別中的投資時,輝瑞如何看待口服藥物與長效注射藥物?
And then real quick, Albert, on the IRA, obviously, it seems here to stay.
然後很快,阿爾伯特,關於愛爾蘭共和軍,顯然,它似乎會留下來。
But when you think about the potential for a new administration, what would Pfizer like to see, obviously, beyond closing the gap between orals and biologics on exclusivity?
但是,當您考慮新政府的潛力時,除了縮小口服藥物和生物製劑在排他性方面的差距之外,輝瑞顯然還希望看到什麼?
Thank you.
謝謝。
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
For orals, to keep it very general, I think you have a number of things that could be advantageous.
對於口頭發言,為了使其非常籠統,我認為您有很多優勢。
One is, of course, they combine so well with all other drugs that are involved in cardiometabolic disease to give long outcomes.
當然,其一是它們與所有其他涉及心臟代謝疾病的藥物結合得很好,可以產生長期的效果。
And what you're looking for, I would say, is 10% to 20% all the way, the lower range for the first GLP.
我想說,你所尋找的是 10% 到 20%,這是第一個 GLP 的較低範圍。
The upper range is where you can see oral-oral combinations edge towards.
上限是您可以看到口頭-口頭組合邊緣的地方。
And that's very much similar to what you can see with a peptide.
這與勝肽所看到的非常相似。
I kept it very broad with a lower and an aspirational range, the lower for more single agents that will edge above that and combo agents that can aspire to go above 15 and an edge above that.
我將其保持在非常寬泛的範圍內,並設定了一個較低的理想範圍,較低的範圍適合更多的單一代理,這些代理將略高於該範圍,而組合代理則可以渴望高於15 並有一個高於該範圍的優勢。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Mikael.
謝謝你,米凱爾。
Now Geoff, on IRA, clearly, IRA overall is negative for innovation and does not promote a spirit that people could provide investments.
現在,當傑夫談到 IRA 時,很明顯,IRA 總體上對創新不利,並且不提倡人們可以提供投資的精神。
But there are also some good things about it.
但它也有一些好處。
So clearly, I wouldn't like to see that the out-of-pocket limit that next year would be $167 per month for all your medicines for seniors, that's what we want to be maintained.
很明顯,我不希望看到明年所有老年人藥品的自付費用限額為每月 167 美元,這是我們希望維持的。
But this forced price setting is not a negotiation, and also the penalty bill are things that need to change.
但這種強制定價並不是談判,罰款法案也是需要改變的。
And it's not only on IRA.
而且這不僅存在於 IRA 上。
I would mention that 340B right now, it is one of the biggest issues, and it is unethical, and it is the way that it is evolving, and it is creating significant transfer of funds from where it needs to be used, the poorer people, to boost the profit lines of some business.
我想提一下,340B 現在是最大的問題之一,這是不道德的,這就是它發展的方式,它正在從需要使用的地方(較貧困的人)創造大量資金轉移,以提高某些業務的利潤線。
So 340B reform is something that myself and the entire pharma is setting as a priority.
所以340B改革是我自己和整個製藥公司優先考慮的事情。
So thank you for your question.
謝謝你的提問。
Next question, please.
請下一個問題。
Operator
Operator
Terence Flynn, Morgan Stanley.
特倫斯‧弗林,摩根士丹利。
Terence Flynn - Analyst
Terence Flynn - Analyst
Great.
偉大的。
Thanks so much.
非常感謝。
Appreciate the questions.
感謝您提出的問題。
Two for me.
給我兩個。
I guess first one is on the RSV opportunity.
我想第一個是 RSV 機會。
Just wondering what you see as the most likely outcome here for revaccination frequency and the potential impact on the longer-term market opportunity.
只是想知道您認為重新接種頻率最可能的結果是什麼以及對長期市場機會的潛在影響。
And then the second question is more of a clarification on your CDK4 inhibitor.
第二個問題更多的是對你的 CDK4 抑制劑的澄清。
You got it to starting a first-line Phase III study early next year.
您已於明年初開始一線 III 期研究。
Just wondering if you can share any more detail there on the design, if that would be a head-to-head versus IBRANCE, and if it would be in combo with [VEFDAG], or if that's a monotherapy-type design.
只是想知道您是否可以分享有關該設計的更多細節,這是否是與 IBRANCE 的正面交鋒,以及它是否會與 [VEFDAG] 組合,或者這是否是單一療法類型的設計。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
All right.
好的。
Aamir, would you like to speak a little bit about the RSV?
阿米爾,您想談談 RSV 嗎?
Aamir Malik - Chief US Commercial Officer, EVP
Aamir Malik - Chief US Commercial Officer, EVP
Yes, just maybe, Terence, to directly answer your question -- so how the market evolves, it's going to be a function of how ACIP recommendations for RSV evolve, and that includes revaccination timeframe, as you mentioned, but also eligible populations.
是的,特倫斯,也許,直接回答你的問題——那麼市場如何發展,將取決於ACIP 對RSV 的建議如何發展,其中包括重新接種時間表,正如你提到的,但也包括符合條件的人群。
I don't think it's really productive for us to predict how ACIP is going to evolve these recommendations.
我認為預測 ACIP 將如何發展這些建議對我們來說並沒有真正的成效。
But we do feel confident in the ABRYSVO profile.
但我們確實對 ABRYSVO 的概況充滿信心。
And importantly, what I would like to highlight is we feel very confident in our ability to pull that profile through.
重要的是,我想強調的是,我們對實現這一目標的能力非常有信心。
You heard Albert describe our momentum in the US market, particularly in light of dramatic improvements in our market share versus last year.
您聽到 Albert 描述了我們在美國市場的發展勢頭,特別是考慮到我們的市場份額與去年相比有了顯著提高。
And we continue to be ready to advance in vaccinations in the fourth quarter as well.
我們也繼續準備在第四季推進疫苗接種工作。
And the last thing I would say is the FDA's recent approval of the 18- to 59-year-old at-risk population makes ABRYSVO the only RSV vaccine that's indicated to protect patients as young as 18 years of age.
我要說的最後一件事是 FDA 最近批准了 18 至 59 歲高風險族群,這使得 ABRYSVO 成為唯一適用於保護年僅 18 歲患者的 RSV 疫苗。
And it further strengthens this perspective on the viability of ABRYSVO.
它進一步強化了對 ABRYSVO 可行性的看法。
Last thing I'll say is on maternal, we have also had really good momentum on our principal maternal indication.
我要說的最後一件事是關於孕產婦的,我們在主要孕產婦適應症方面也取得了非常好的動力。
We see very strong signals in uptake for the month of September.
我們看到 9 月的吸收訊號非常強烈。
We had a 20% uptake, which is a full doubling of where we ended the last season, and we continue to see uptake amongst OBGYNs and health systems.
我們的使用率達到了 20%,這是上個季度結束時的兩倍,而且我們繼續看到婦產科醫生和衛生系統的使用率不斷提高。
So in the first four weeks of this season, the units that we shipped into those systems are up 56% from the first four weeks of last season.
因此,在本賽季的前 4 週,我們運送到這些系統的單位數量比上賽季的前 4 週增加了 56%。
So we see momentum on ABRYSVO, and we look forward to future ACIP updates.
因此,我們看到了 ABRYSVO 的勢頭,並期待未來的 ACIP 更新。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And Alexandre, you want to add something on the international because that's also an important market for us?
亞歷山大,你想在國際市場上添加一些東西,因為這對我們來說也是一個重要的市場?
Alexandre de Germay - Chief International Commercial Officer, EVP
Alexandre de Germay - Chief International Commercial Officer, EVP
Yes, absolutely.
是的,絕對是。
Even though it's still not material yet, we are actually making very good progress.
儘管還不是實質的,但我們實際上已經取得了很好的進展。
So on the adult front, we actually got [VTC] recommendations since the beginning of the year in large markets like UK, Germany, in France, in Canada, in Australia, in Saudi Arabia, and a lot of other mid-sized markets.
因此,在成人方面,自今年年初以來,我們實際上在英國、德國、法國、加拿大、澳洲、沙烏地阿拉伯和許多其他中型市場等大型市場獲得了 [VTC] 推薦。
Lots of positive VTC recommendations.
VTC 有很多積極的建議。
Now we're moving into funding.
現在我們正進入融資階段。
And on the second quarter, we said that we won the exclusive UK tender.
在第二季度,我們表示我們贏得了英國獨家招標。
That's what we did.
這就是我們所做的。
We also won the Canadian tender.
我們還贏得了加拿大招標。
Now in terms of reimbursement, we just got actually regional reimbursement in Germany, and we are launching at least in October in Germany.
現在在報銷方面,我們實際上剛剛在德國獲得了區域報銷,並且我們至少在十月在德國推出。
Now, all the others, the large market and the mid-sized market that I've talked about, are in phase of negotiation.
現在,所有其他的,我談到的大型市場和中型市場,都處於談判階段。
On the adult side, the last thing I want to say is actually we are working toward our immuno-bridging study in 2025 in China so that we can do an NDA filing, which is also an important market for us.
在成人方面,我想說的最後一件事是,實際上我們正在努力於2025年在中國進行免疫橋接研究,以便我們可以進行NDA備案,這對我們來說也是一個重要的市場。
On the pediatric side, also, we are making good progress.
在兒科方面,我們也取得了良好進展。
We also got VTC recommendation in large market like the UK, in France, in Australia, in several other mid-sized markets.
我們也在英國、法國、澳洲以及其他幾個中型市場等大型市場獲得了 VTC 推薦。
And actually, yesterday, we just got also the Pan American Health Organization that covered 40 markets in the Americas that actually listed agreeable in their RSVC recommendation.
事實上,昨天,我們剛剛得到涵蓋美洲 40 個市場的泛美衛生組織的 RSVC 建議,該組織實際上表示同意。
So we're getting also reimbursements in France, and we have actually just launched in France recently.
因此,我們在法國也獲得了報銷,實際上我們最近剛在法國推出。
There again, on pediatrics, once we got all those positive recommendations, we are moving into reimbursements.
再說一次,在兒科方面,一旦我們得到所有這些積極的建議,我們就會開始報銷。
So we see great potential.
所以我們看到了巨大的潛力。
It's going to take a bit of time because we go through all those different steps, but we see good potential there.
這將需要一些時間,因為我們要經歷所有這些不同的步驟,但我們看到了那裡的巨大潛力。
Absolutely.
絕對地。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you.
謝謝。
And then why don't we go to Chris for the question on the design of the Phase 3?
那我們為什麼不去找 Chris 詢問有關第三階段設計的問題呢?
Chris Boshoff - Chief Oncology Officer, EVP
Chris Boshoff - Chief Oncology Officer, EVP
Thank you very much for the question.
非常感謝你的提問。
On atirmociclib, our highly selective CDK4 inhibitor, this was another small molecule that was conceptualized and discovered in our laboratories in La Jolla.
atirmociclib(我們的高選擇性 CDK4 抑制劑)是我們在拉霍亞的實驗室概念化和發現的另一種小分子。
And it's currently in a Phase 3 program for second-line plus hormone receptor-positive breast cancer.
目前該藥物正處於治療二線+荷爾蒙受體陽性乳癌的第三階段計畫。
And this is potentially not only a first-in-class but best-in-class highly selective CDK4 inhibitor.
這不僅可能是同類首創,而且是同類最佳的高選擇性 CDK4 抑制劑。
And as you know, CDK6 leads to some of the vulnerabilities including the bone marrow toxicity, and that's why we're focusing on CDK4, which drive breast cancer proliferation.
如您所知,CDK6 會導致一些脆弱性,包括骨髓毒性,這就是為什麼我們關注 CDK4,它會促進乳癌增殖。
So we believe with the current data, including the safety and tolerability, the early clinical data support the potential for more complete and continuous dosing with CDK4.
因此,我們相信,根據目前的數據,包括安全性和耐受性,早期臨床數據支持 CDK4 更完整和持續給藥的潛力。
And as you've seen, we've got no Grade 4 neutropenia, no Grade 3 or 4 diarrhea, and no Grade 4 treatment-related AEs was observed.
正如您所看到的,我們沒有觀察到 4 級中性粒細胞減少症,沒有 3 級或 4 級腹瀉,也沒有觀察到 4 級治療相關的 AE。
We've aligned with the FDA on the first-line hormone receptor-positive breast cancer study, which will start in the coming months, and it will be against physicians' choice of CDK4/6 inhibitor.
我們已與 FDA 就一線荷爾蒙受體陽性乳癌研究達成一致,該研究將於未來幾個月開始,並將反對醫生選擇 CDK4/6 抑制劑。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you.
謝謝。
Next question, please.
請下一個問題。
Operator
Operator
Evan Seigerman, BMO Capital Markets.
Evan Seigerman,BMO 資本市場。
Evan Seigerman - Analyst
Evan Seigerman - Analyst
Hi there. thank you for taking my question.
你好呀。謝謝你回答我的問題。
So I have one for Andrew in honor of what I believe is his first call on the other side.
所以我為安德魯準備了一個,以紀念我相信這是他在另一邊的第一次通話。
In your first four months or so, can you help us better understand your findings regarding the portfolio?
在您的前四個月左右的時間裡,您能幫助我們更了解您對投資組合的發現嗎?
And more broadly, how do you hope to shape and focus the wide variety of assets that Pfizer has to drive sustainable growth?
更廣泛地說,您希望如何塑造和集中輝瑞所擁有的各種資產來推動永續成長?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
So now that you're in the dark side, what is your opinion, my friend?
那麼現在你處於黑暗面,你的意見是什麼,我的朋友?
Andrew Baum - Chief Strategy and Innovation Officer, EVP
Andrew Baum - Chief Strategy and Innovation Officer, EVP
Well, I think, a, Evan, thank you for the question; b, I think in response to Albert's question, I think coming from finance, I guess pharma is stepping to the light side rather than the dark side.
嗯,我想,埃文,謝謝你的提問; b,我認為在回答阿爾伯特的問題時,我認為從金融角度來看,我認為製藥公司正在走向光明的一面,而不是黑暗的一面。
But in terms of the question, look, I've always regarded Pfizer's R&D engine highly, just because when you look at the stream of molecules that have been internally discovered at Pfizer over the years, first ALK inhibitor, first CDK4/6 inhibitor, numerous JAKs, ABRYSVO, there's clearly a very, very strong record of discovery and execution.
但就這個問題來說,你看,我一直很重視輝瑞的研發引擎,只是因為你看這些年來輝瑞內部發現的分子流,第一個ALK抑制劑,第一個CDK4/6抑制劑,無數的JAK,ABRYSVO,顯然有非常非常強大的發現和執行記錄。
And it's not just small molecules I hasten to add.
我急於添加的不僅僅是小分子。
You see that in vaccines and oligos and cell therapies and bispecifics.
你可以在疫苗、寡核苷酸、細胞療法和雙特異性藥物中看到這一點。
And for me, when I made the move, this was absolutely key in terms of a company that had this.
對我來說,當我採取行動時,這對擁有這種能力的公司來說絕對是關鍵。
Because if you don't have this, then life is very, very difficult.
因為如果你沒有這個,那么生活將會非常非常困難。
Now in answer to where I hope to add value coming forward, I think as Albert alluded to earlier, historically, perhaps we may have pursued areas where that R&D investment hasn't translated into the type of revenues you want.
現在,在回答我希望未來增加價值的地方時,我認為正如阿爾伯特早些時候提到的那樣,從歷史上看,也許我們所追求的領域的研發投資尚未轉化為您想要的收入類型。
The point is that this is a much easier challenge to solve.
關鍵是這是一個更容易解決的挑戰。
It's a matter of taking this incredibly powerful machine and pointing it in the right direction so that we are targeting those areas that translate into revenues.
問題在於如何利用這台極其強大的機器並將其指向正確的方向,以便我們可以瞄準那些能夠轉化為收入的領域。
If there's one thing that I think the COVID experience shows you is once Pfizer focuses, execution is something you should feel very comfortable about.
如果說我認為新冠疫情的經驗向你展示了輝瑞一旦聚焦的一件事,那麼執行力就是你應該感到非常舒服的事情。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Andrew and Evan, for the question.
謝謝安德魯和埃文提出的問題。
Next question, please.
請下一個問題。
Operator
Operator
(Operator Instructions) Courtney Breen, Bernstein.
(操作員說明)考特尼·布林,伯恩斯坦。
Courtney Breen - Analyst
Courtney Breen - Analyst
Hi, everyone.
大家好。
Thanks so much for the time today.
非常感謝今天的時間。
This is Courtney Breen from Bernstein.
我是伯恩斯坦的考特尼·布林。
Perhaps building on the last question, looking at slide 28 in the presentation today, it suggested that in the last three months from the end of July to today that there has been no meaningful advancement of the pipeline, albeit there are a number of pipeline actions kind of suggested to be initiating soon.
也許在最後一個問題的基礎上,看看今天演示中的幻燈片 28,它表明,從 7 月底到今天的過去三個月裡,儘管有許多管道行動,但管道沒有任何有意義的進展建議盡快啟動。
We're suggesting this is likely as a response to the reset and cost cutting that's going on.
我們認為這可能是對正在進行的重置和成本削減的回應。
My first part to this question is how will you ensure that this isn't repeated in further quarters, and how are you balancing the need to kind of take stock and cut while ensuring that high potential opportunities are getting appropriately accelerated through the pipeline?
我對這個問題的第一部分是,您將如何確保這種情況在未來幾季不會重演,以及您如何平衡盤點和削減的需要,同時確保高潛在機會通過管道得到適當加速?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Then maybe I will ask the two R&D heads to comment on that.
然後也許我會請兩位研發負責人對此發表評論。
Please, let's start with Chris.
請讓我們從克里斯開始。
Chris Boshoff - Chief Oncology Officer, EVP
Chris Boshoff - Chief Oncology Officer, EVP
Yes, thank you for the question.
是的,謝謝你的提問。
So just a reminder, this year, we've already started eight new first-in-patient studies in oncology, which I believe makes us the number-one and company in terms of Phase 1 clinical trials started.
所以提醒一下,今年,我們已經開始了八項新的腫瘤學首次患者研究,我相信這使我們成為一期臨床試驗啟動方面的第一名和第一家公司。
In the coming months, we expect potential Phase 3 readouts for BREAKWATER, which is a very important indication for us in BRAF mutated colorectal cancer, which is up to 10% of colorectal cancer.
在接下來的幾個月中,我們預計 BREAKWATER 可能會出現 3 期結果,這對我們來說是 BRAF 突變結直腸癌的一個非常重要的適應症,佔結直腸癌的 10%。
That will be in the first-line setting, a big unmet need, because there's particularly poor prognosis in patients presenting with BRAF mutated colorectal cancer.
這將是一線治療,這是一個巨大的未滿足的需求,因為患有 BRAF 突變的結直腸癌患者的預後特別差。
We also expect readouts for VERITAC-2, our ER PROTAC we're co-developing with Arvinas for ER-positive second-line plus metastatic breast cancer and potentially for CREST, which is sasanlimab, a differentiated subcut PD-1 in combination with BCP in non-muscle invasive bladder cancer.
我們也預期VERITAC-2 的讀數,這是我們與Arvinas 共同開發的用於ER 陽性二線及轉移性乳癌的ER PROTAC,並且可能用於CREST,即sasanlimab,一種與BCP 組合的差異化subcut PD -1在非肌肉層浸潤性膀胱癌。
We will also present in the coming months Phase 2 randomized data for mevrometostat.
我們還將在未來幾個月內提供 mevrometostat 的第二階段隨機資料。
This is randomized Phase 2 data in patients with prostate cancer.
這是前列腺癌患者的隨機 2 期數據。
We've seen the data, and that provided us the confidence to initiate the two Phase 3 programs.
我們已經看到了這些數據,這讓我們有信心啟動這兩個第三階段計畫。
In the coming months, we'll also start additional Phase 3 studies, as I mentioned, CDK4, in first-line ER-positive breast cancer, Sigvotatug vedotin in combination with pembrolizumab, in PD-L1 high, first-line non-small cell lung cancer, and CAT6 in ER-positive breast cancer.
在接下來的幾個月裡,我們還將開始更多的3 期研究,正如我所提到的,CDK4,用於一線ER 陽性乳腺癌,Sigvotatug vedotin 聯合pembrolizumab,用於PD-L1 高一線非小細胞肺癌細胞肺癌和 ER 陽性乳癌中的 CAT6。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
So quite impressive from the oncology side.
從腫瘤學方面來看,非常令人印象深刻。
Mikael, what about the rest?
米凱爾,剩下的呢?
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Yes, we thought we'd help you to focus by this quarter displaying some nice movement at the most valuable part of this chart, the right hand.
是的,我們認為本季我們會幫助您集中註意力,在該圖表中最有價值的部分(右手)上展示一些漂亮的動作。
When you look over the next 18 months and including oncology and non-oncology, we will have up to 40 different opportunities to fill the left side that I hear you are eager to see progress on.
當您展望未來 18 個月(包括腫瘤學和非腫瘤學)時,我們將有多達 40 個不同的機會來填補左側,我聽說您渴望看到進展。
And the right turn, it will include -- the 40 will be divided between potential approvals, projected pivotal readouts, and potential proof of concept.
正確的做法是,這 40 個項目將分為潛在的批准、預期的關鍵讀數和潛在的概念驗證。
And that did not even include early signals in clinical development.
這甚至不包括臨床開發中的早期訊號。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Courtney, for the question.
謝謝考特尼提出的問題。
Next, the question, please.
接下來請提問。
Operator
Operator
Steve Scala, TD Cowen.
史蒂夫·斯卡拉,TD·考恩。
Steve Scala - Analyst
Steve Scala - Analyst
Thank you very much.
非常感謝。
Pfizer has previously stated it anticipated having visibility on long-term COVID product sales based on 2024 trends.
輝瑞先前曾表示,預計將根據 2024 年趨勢了解新冠肺炎產品的長期銷售情況。
Since we are now nearing the end of 2024, I'm wondering what that long-term number is.
由於現在已接近 2024 年底,我想知道這個長期數字是多少。
And then secondly, does Pfizer have the Phase 3 booster data for the RS vaccine in adults in-house?
其次,輝瑞內部是否有成人 RS 疫苗的第三階段加強數據?
And if yes, does the data show a similar step down in booster immunogenicity as did the GSK vaccine?
如果是,數據是否顯示出與葛蘭素史克疫苗類似的增強免疫原性下降?
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
All right.
好的。
So on the stability, let's maybe -- Aamir, do you want to make a comment?
那麼關於穩定性,我們也許——阿米爾,你想發表評論嗎?
I could also comment, but why don't you?
我也可以發表評論,但為什麼不呢?
Aamir Malik - Chief US Commercial Officer, EVP
Aamir Malik - Chief US Commercial Officer, EVP
Let me just comment on performance.
我只評論一下性能。
I think -- Steve, I think both on Paxlovid and COMIRNATY, I think with our performance to date, as well as the quarter, which show us is that these are both entering into a category where we understand what the volumes are likely to be and we believe these are going to be durable businesses going forward.
我認為 - 史蒂夫,我認為在 Paxlovid 和 COMIRNATY 上,我認為根據我們迄今為止的表現以及本季度的表現,這向我們表明,這些都正在進入一個我們了解銷量可能達到的類別我們相信這些將成為未來持久的業務。
So just as an example on Paxlovid, even if you take the one-time items that Dave alluded to aside for a moment, we've seen significant Paxlovid treatment course utilization, right?
因此,以 Paxlovid 為例,即使您暫時將 Dave 提到的一次性項目放在一邊,我們也看到了 Paxlovid 療程的大量使用,對吧?
Even just in the summer wave that happened over the course of the third quarter, we saw an average of about 100,000 courses of treatment at the start of July, growing to about 225,000 treatment courses in mid-August before that wave declined.
即使僅在第三季發生的夏季浪潮中,我們在 7 月初就看到平均約 100,000 個療程,在 8 月中旬增長到約 225,000 個療程,然後該浪潮下降。
And we've built a very durable commercial engine to support that with increasing treatment rates, with very viable reimbursement both on the government side as well as on the commercial side, and a way to activate HCPs and consumers who need treatment.
我們已經建立了一個非常耐用的商業引擎來支持這一目標,提高治療率,在政府方面和商業方面都提供非常可行的報銷,以及一種激活醫療保健專業人員和需要治療的消費者的方法。
And similarly, on the vaccine, our goal this year with COMIRNATY, and we had the benefit of being able to start three weeks before last year, was to start the season with plenty of vaccine in fridges, both in the retail setting as well as in the health system setting.
同樣,在疫苗方面,我們今年與 COMIRNATY 的目標是在冰箱中存放大量疫苗,無論是在零售環境還是在去年,我們的優勢是能夠在去年三週前開始。
And again, we've demonstrated an ability to do that quite well.
我們再次證明了我們有能力很好地做到這一點。
When you look at where vaccination is this year versus last year, it's a little bit higher, actually, but a big part of that is just a function of the calendar and the three weeks earlier.
當你看看今年的疫苗接種情況與去年相比,實際上要高一些,但其中很大一部分只是日曆和前三週的函數。
We expect to see vaccinations continue in October through December.
我們預計疫苗接種將在 10 月至 12 月繼續進行。
And the shape of that curve will continue to evolve, but all of this makes us confident that we're seeing a durable business, both on vaccines and Pax.
曲線的形狀將繼續演變,但所有這些都讓我們相信,我們在疫苗和 Pax 方面都看到了持久的業務。
Alexandre de Germay - Chief International Commercial Officer, EVP
Alexandre de Germay - Chief International Commercial Officer, EVP
And for international, this is Alexandre, thanks for the question too, same principles we see in during business.
對於國際業務,我是亞歷山大,也感謝您提出問題,我們在業務中看到的原則相同。
In COMIRNATY, I just want to remind everyone that in the international division, we close our third quarter at the end of August.
在COMIRNATY,我只想提醒大家,在國際部門,我們將在八月底結束第三季。
So basically, you don't see any sales of community simply because most markets are starting their vaccination campaign in September.
所以基本上,您不會看到任何社區銷售,只是因為大多數市場在 9 月開始了疫苗接種活動。
Having said that, we're progressing very nicely in our key regions.
話雖如此,我們在關鍵地區的進展非常順利。
So in Europe, we got the approval of the Gen 1 adapted vaccine in July, and we got the [KP2] adapted vaccine in September.
因此,在歐洲,我們在 7 月獲得了 Gen 1 適應疫苗的批准,並在 9 月獲得了 [KP2] 適應疫苗。
Since basically end of August, we started to work with our healthcare authorities partner in Europe, where we have an existing contract, to implement the multi-year contract that is in place.
基本上從八月底開始,我們就開始與歐洲的醫療保健機構合作夥伴(我們在歐洲有一份現有合約)合作,以實施現有的多年期合約。
Same thing in the UK and Canada, we've also worked with the other authority to actually execute our contract.
在英國和加拿大也是如此,我們也與其他當局合作來實際執行我們的合約。
In Japan, we also got the general adapted vaccine approved in mid-September, and COMIRNATY is actually the only PFS vaccine never frozen, which could be a competitive advantage considering the distribution model in Japan.
在日本,我們也在9月中旬獲得了通用適應疫苗的批准,而COMIRNATY實際上是唯一從未冷凍過的PFS疫苗,考慮到日本的分銷模式,這可能是一個競爭優勢。
So again, we see this as an enduring business and we see us, as I said, executing our existing contract in our key location.
因此,我們再次將其視為一項持久的業務,正如我所說,我們正在我們的關鍵地點執行現有合約。
From a Paxlovid standpoint, Q3 was a good Q3 for us, and it's actually very good because it satisfies our perception that Paxlovid is a sustainable business with sustainable demand, which coincides with the COVID waves.
從Paxlovid 的角度來看,第三季度對我們來說是一個很好的第三季度,實際上非常好,因為它滿足了我們的看法,即Paxlovid 是一家具有可持續需求的可持續業務,這與新冠疫情浪潮相吻合。
And we had quite a strong spring wave in Europe and Asia, and that translated into immediate demand.
我們在歐洲和亞洲經歷了相當強勁的春季浪潮,這轉化為直接需求。
Just to close, I want to say that 47 countries outside of the US have transitioned from advanced purchasing into commercial.
最後,我想說的是,美國以外的 47 個國家已經從高級採購過渡到商業採購。
So as we see in the US, it is enduring, and now the sales that we see quarter after quarter reflect the absolute demand and reflect the waves as they hit the different regions of the world.
因此,正如我們在美國看到的那樣,它是持久的,現在我們每季看到的銷售反映了絕對需求,並反映了衝擊世界不同地區的浪潮。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And Steve, also, I can't resist also making some comments.
史蒂夫,我也忍不住發表一些評論。
In the 5.5 years as CEO, I had 23 earnings releases, of which 22 we beat EPS of Bloomberg and one we missed.
在擔任執行長的 5.5 年裡,我發布了 23 次收益報告,其中 22 次我們超過了彭博社的每股收益,還有一次我們錯過了。
And I don't like the one that we missed, and that was in Q3 last year, and we missed it because of COVID.
我不喜歡我們錯過的那個,那是去年第三季的,我們因為新冠疫情而錯過了它。
We severely miscalculated.
我們嚴重失算了。
Yes, there are excuses that the last pandemic was 100 years ago, so we didn't have, let's say, a benchmark.
是的,有藉口說上一次大流行是在 100 年前,所以我們沒有,比如說,一個基準。
And also, we had to reduce it significantly.
而且,我們還必須大幅減少它。
We had $56 billion of COVID revenue in 2022, and we had a guidance of 22.
2022 年,我們的新冠肺炎收入為 560 億美元,指引值為 22。
So we reduced it at 40% on what it used to be.
因此,我們將其比以前減少了 40%。
However, life proved that we got it wrong, and us, and Moderna, and everybody else.
然而,生活證明我們錯了,我們、Moderna、其他人都錯了。
And the reality was that it was not 22, but 12.
而現實情況是,它不是 22,而是 12。
So we are very careful now when we speak about COVID because we don't want to miss it again.
因此,我們現在在談論新冠病毒時非常小心,因為我們不想再錯過它。
But I would like to say that when I see the trends of the COVID business, Paxlovid, which for us is even more important because of the higher level of profitability, it is basically identical to the utilization of last year compared to this year.
但我想說,當我看到新冠業務 Paxlovid 的趨勢時,這對我們來說更為重要,因為盈利水平更高,與今年相比,它與去年的利用率基本相同。
So far, we had 4.9 million patients treated until Q3 with Paxlovid in the US, compared to 5.2 million people last year, the same period.
到目前為止,截至第三季度,美國已有 490 萬名患者接受 Paxlovid 治療,而去年同期為 520 萬人。
The treatment rates have improved from 50% last year to 57%, and the fulfillment rates went a little bit down because now there is co-paying.
治療率從去年的 50% 提高到了 57%,但由於現在有了自付費用,履行率略有下降。
From 88%, it went to 81%, but it's very, very stable.
從88%,到了81%,但非常非常穩定。
The same is with the COVID vaccination.
新冠疫苗接種也是如此。
When you see the trends of COVID vaccinations, the utilizations are basically the same like last year, more or less.
當你看到新冠疫苗接種的趨勢時,你會發現使用率與去年基本相同,或多或少。
And still, it's early in the season, so there could be fluctuations over there.
儘管如此,現在還處於季節初期,因此那裡可能會出現波動。
So I think your statement that shall we consider COVID as normal business now, it's absolutely true.
所以我認為你所說的我們現在應該將新冠病毒視為正常事務的說法絕對正確。
And this is how we regard it.
這就是我們的看法。
And we will stop separating our business to COVID/non-COVID because it's Pfizer business.
我們將停止將我們的業務與新冠病毒/非新冠病毒分開,因為這是輝瑞的業務。
And with that, I will ask Mikael to make a comment on the RSV.
接下來,我將請 Mikael 對 RSV 發表評論。
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Thank you for your question.
謝謝你的提問。
We have started to accumulate data on both durability and the impact of revaccination for RSV.
我們已開始累積有關 RSV 持久性和重新接種影響的數據。
On the majority of patients that we expected to go to pharmacy for revaccination, the titers remain robust after one and even two years, which is -- punctuate the quality of our vaccine.
對於我們預計去藥局重新接種疫苗的大多數患者,一年甚至兩年後滴度仍然強勁,這證明了我們疫苗的品質。
But they, of course, decline gradually.
但它們當然會逐漸衰退。
And we can have some meaningful improvement in those titers with a booster.
透過加強劑,我們可以對這些滴度進行一些有意義的改善。
But I believe that likely in three years, around three years, we will see a drop in the titer that makes the boost really improve meaningfully the protection for a substantial fraction of the patients.
但我相信,很可能在三年內,大約三年後,我們將看到滴度下降,這使得增強劑真正有效地改善了對相當一部分患者的保護。
And that's what we are going to monitor now, whether the three years is a good interval.
這就是我們現在要監控的,這三年是否是個好的間隔。
But otherwise, it's performing exactly as expected for a high-quality vaccine.
但除此之外,它的表現完全符合高品質疫苗的預期。
Now there could be patient groups that go to physician offices that are more immunocompromised, moderate to severe patients that may benefit from a once-a-year, and that would be more a physician directive.
現在,可能會有一些患者群體前往醫生辦公室就診,這些患者的免疫功能較弱,中度至重度患者可能會受益於每年一次,這將更像是醫生的指示。
So I hope that will give you a bit of an understanding how this will evolve.
所以我希望這能讓你稍微了解這將如何發展。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Mikael.
謝謝你,米凱爾。
Next question please.
請下一個問題。
Operator
Operator
Rajesh Kumar, HSBC.
拉傑什·庫馬爾,匯豐銀行。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
Hi there.
你好呀。
My apologies, I was on mute.
抱歉,我當時處於靜音狀態。
So two questions, if I may.
如果可以的話,有兩個問題。
What is the impact of Part D and IRA on your business next year?
D 部分和 IRA 對您明年的業務有何影響?
Are there any numbers you're calling out which might help us with the modeling?
您提出的任何數字可以幫助我們進行建模嗎?
That would be very helpful to understand if there are any impacts.
這對於了解是否有任何影響非常有幫助。
And the second one is, I appreciate the color on the Seagen pipeline and how you're progressing and how the market underappreciates the size of the opportunity.
第二個是,我欣賞 Seagen 管道的顏色以及您的進展以及市場如何低估機會的規模。
The sell-side estimates clearly do not reflect your optimism.
賣方的估計顯然沒有反映出您的樂觀情緒。
When is it that you'll feel a bit more confident or what do you need to see to increase your longer-term guidance on Seagen?
您什麼時候會感到更有信心,或者您需要看到什麼來增加您對 Seagen 的長期指導?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you.
謝謝。
Dave, can you take the IRA impact next?
戴夫,接下來你能承受 IRA 的影響嗎?
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
Yes, I'll just hit on it very briefly.
是的,我會簡單地講一下。
Obviously, the IRA in that, the redesign has pluses and pushes and pulls to us as we cycle into next year.
顯然,愛爾蘭共和軍的重新設計有其優點,並且在我們進入明年時對我們有推動和拉動。
When we provide guidance by the end of this year, we will give you a view on the net impact of that as we think about our business.
當我們在今年年底之前提供指導時,我們將在我們考慮我們的業務時向您提供其淨影響的看法。
So more to come, hold tight on that.
未來還會有更多,請抓緊。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And there are puts and takes, so positive things and negative things, right?
還有投入和拿取,所以正面的事情和負面的事情,對吧?
So we need to assess it as we are building now these calculations, as we are building our budgets for next year.
因此,我們需要在我們現在進行這些計算和製定明年的預算時對其進行評估。
Seagen pipeline.
希根管道。
Chris?
克里斯?
Chris Boshoff - Chief Oncology Officer, EVP
Chris Boshoff - Chief Oncology Officer, EVP
Yes, thank you for the question.
是的,謝謝你的提問。
So I think last year at this time, we didn't expect we're going to have PADCEV approved in first-line bladder, and everyone forecasted that approval for the first half of this year.
所以我認為去年的這個時候,我們沒有想到 PADCEV 會在一線膀胱中獲得批准,每個人都預測今年上半年會獲得批准。
And obviously, the approval happened very early because of the unprecedented data.
顯然,由於史無前例的數據,批准很早就發生了。
So I think the performance commercially is really as we expected or exceeded what we expected in 2024.
所以我認為商業上的表現確實符合我們的預期或超出了我們2024年的預期。
If you look at the rest of the pipeline now, the new molecules like Sigvotatug vedotin and desitamab, PD-L1V, as well as next-generation, CD30 ADC called 35C for (inaudible), we will present next year at conferences more updated data on these, including in combination with pembrolizumab for Sigvotatug vedotin for DB and for PD-L1B, as well as really highly encouraging data for 35C, the next-generation CD30.
如果您現在查看其餘的產品線,例如 Sigvotatug vedotin 和 desitamab、PD-L1V 等新分子,以及稱為 35C 的下一代 CD30 ADC(聽不清楚),我們將在明年的會議上展示更多更新資料在這些方面,包括與pembrolizumab 聯合用於Sigvotatug vedotin 用於DB 和PD-L1B,以及35C(下一代CD30)的非常令人鼓舞的數據。
So I think by showing and releasing more data next year will help all of you to build confidence in the pipeline.
因此,我認為透過明年展示和發布更多數據將幫助大家建立對管道的信心。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Chris.
謝謝你,克里斯。
And thank you for the question, Rajesh.
謝謝你的提問,拉傑什。
Next question, please.
請下一個問題。
Operator
Operator
Akash Tewari, Jefferies.
阿卡什·特瓦里,杰弗里斯。
Akash Tewari - Analyst
Akash Tewari - Analyst
Hey, thanks so much.
嘿,非常感謝。
So looking at some of your IP around 25-valent PREVNAR, it looks like you'll have to step up versus your previous 20-valent vaccine.
因此,請看看您關於 25 價 PREVNAR 的一些 IP,看起來您必須加強與先前的 20 價疫苗的比較。
But it does look like effective serotype coverage could lag meaningfully versus Merck and Vaxcyte approaches by 10% or more in older adults.
但看起來在老年人中,有效的血清型覆蓋率可能比默克和 Vaxcyte 的方法明顯滯後 10% 或更多。
How confident are you that this fourth-gen vaccine could stave off a preferential wreck from some of your peers down the line in adults?
您對這種第四代疫苗能夠避免您的一些同齡人在成人中優先遭受破壞的信心有多大嗎?
And then number two, can you talk about what special properties your once-daily modified-release danuglipron could have outside of improved half-life that investors might be underappreciating?
第二,您能否談談您的每日一次改良釋放 danuglipron 除了改善半衰期之外,還有哪些投資者可能低估的特殊特性?
I think those earlier comments stood out to us.
我認為那些早期的評論對我們來說很突出。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Mikael?
米凱爾?
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Yes.
是的。
The 25-valent that you asked about, the fourth generation, we aspire to be the one that first hits the pediatric market, which is where the bulk of use of doses -- but we also think because of this unique improvement of serotype 3 that is far more important than several of the other tiny serotypes will bring an overall value to the adult segment, that will be very meaningful.
您問到的 25 價疫苗是第四代,我們渴望成為第一個進入兒科市場的產品,這是大部分劑量使用的地方 - 但我們也認為,由於血清型 3 的這種獨特改進,比其他幾種微小血清型重要得多,將為成人細分市場帶來整體價值,這將非常有意義。
And as you have heard, we are working on a fifth generation that will include both improved performance such as serotype 3 and go far beyond any of those serotypes that you are talking about in numbers.
正如您所聽說的,我們正在開發第五代,它將包括改進的性能,例如血清型 3,並且遠遠超出您在數字上談論的任何血清型。
We use 30 plus just to keep a bit of detail for the future.
我們使用 30 plus 只是為了保留一些細節以供將來使用。
For the QD, I think, in general, you saw of course with injectable when you went from once a day to once a week and you got a smoother profile and reduced the number of peaks, that many patients perform better on them.
對於 QD,我認為,一般來說,當您從每天一次改為每週一次時,您當然會看到注射劑,您會獲得更平滑的輪廓並減少峰值數量,許多患者在註射時表現更好。
So that's a hypothesis we are keeping our eyes on: that with a modified release, you will have a more smooth profile.
因此,這是我們一直關注的假設:透過修改版本,您將擁有更流暢的設定檔。
You avoid certainly additional high peaks that immediate release has, and that's something we've seen in other formulation of other drugs.
您當然可以避免立即釋放所具有的額外高峰,這是我們在其他藥物的其他配方中看到的。
And that's why I think we are trying to be attentive in order to have our eyes on details that can help to make this product a really nice oral product with some differentiation.
這就是為什麼我認為我們正在努力關注細節,這些細節有助於使該產品成為真正優秀的具有一定差異化的口服產品。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Mikael.
謝謝你,米凱爾。
Next question.
下一個問題。
Operator
Operator
Vamil Divan, Guggenheim Securities.
瓦米爾·迪萬,古根漢證券公司。
Vamil Divan - Analyst
Vamil Divan - Analyst
Great.
偉大的。
Thanks for taking my question.
感謝您提出我的問題。
So I have a few, but I'll keep it to two.
所以我有一些,但我會保留為兩個。
So one, just on the guidance for the full year, you increased the total sales guidance by $1.5 billion.
因此,僅根據全年指導,您就將總銷售指導增加了 15 億美元。
You increased the COVID products by $2 billion.
您將新冠肺炎產品增加了 20 億美元。
So I guess you're lowering the non-COVID by about 500 million.
所以我猜你將非新冠疫情人數減少了約 5 億。
I guess some of that looks bright up.
我想其中一些看起來很明亮。
But I'm wondering if there's anything else you might call out, where you're sort of trimming your expectations for the full year.
但我想知道您是否還有其他需要指出的地方,即您是否正在削減全年的預期。
And then second one, sort of tied to the OXBRYTA news from a few weeks ago, we noticed the GBT-601, Osivelotor.
然後第二個,有點與幾週前的 OXBRYTA 新聞相關,我們注意到了 GBT-601,Osivelotor。
So that seems to be progressing still in your pipeline.
所以這似乎仍在您的管道中取得進展。
I'm just curious if you're contemplating or have you made any changes to that approach?
我只是好奇您是否正在考慮或是否對這種方法做出了任何改變?
And the mechanism is obviously similar to OXBRYTA.
而其機制顯然與OXBRYTA相似。
So I'm just wondering if any of you have learned from the OXBRYTA situation.
所以我想知道你們中是否有人從 OXBRYTA 的情況中吸取了教訓。
Should we think about carrying over to this one?
我們是否應該考慮繼續這個問題?
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Vamil.
謝謝你,瓦米爾。
Dave?
戴夫?
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
Yes, on the guidance from a revenue perspective, you're absolutely correct.
是的,從收入角度來看,你是完全正確的。
We increased our overall guidance by $1.5 billion.
我們將整體指導意見增加了 15 億美元。
We increased Paxlovid by $2 billion, which implies a $500 million compression someplace else in the business.
我們將 Paxlovid 增加了 20 億美元,這意味著業務中其他地方的資金壓縮了 5 億美元。
Think about that as largely OXBRYTA.
很大程度上將其視為 OXBRYTA。
We're absorbing the OXBRYTA headwind and maintaining our 9% to 11% growth rate in our non-COVID business, which actually implies that our baseline business is actually performing quite well.
我們正在吸收 OXBRYTA 的逆風,並在非新冠疫情業務中保持 9% 至 11% 的成長率,這實際上意味著我們的基準業務實際上表現得相當不錯。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And I want to remind that the non-COVID business was 14% growth this quarter.
我想提醒一下,本季非新冠疫情業務成長了 14%。
Then, Mikael?
那麼,米凱爾?
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Yes, on one end, with Osivelotor, which was previously called 601, yes, I am encouraged about that opportunity.
是的,一方面,對於 Osivelotor,以前被稱為 601,是的,我對這個機會感到鼓舞。
And of course, we try here to incorporate learnings, how OXBRYTA was developed to our advantage.
當然,我們在這裡嘗試將 OXBRYTA 的開發經驗融入我們的優勢中。
As you know, that drive was already approved 2019 when we did acquisition a bit later and with several programs already up and running.
如您所知,該驅動器已於 2019 年獲得批准,當時我們稍後進行了收購,並且多個專案已啟動並運行。
601 by itself is at a tenfold lower dose.
601 本身的劑量要低十倍。
It has more potency and brings more improvement for hemolytic anemia as one example.
例如,它對溶血性貧血具有更大的功效並帶來更多的改善。
So this part has performed very well in our Phase 2 and looked really nice in tolerability, so I'm optimistic about that one.
所以這一部分在我們的第二階段中表現得非常好,並且在耐受性方面看起來非常好,所以我對此感到樂觀。
When I speak about trial learnings, OXBRYTA was performed in the more recent studies in a part of the world where it's really difficult to do the type of high-quality consistent three clinical trials.
當我談到試驗學習時,OXBRYTA 是在世界某個地區進行的最新研究中進行的,在這些地區很難進行高品質、一致的三項臨床試驗。
And as we investigate in some of those learnings with OXBRYTA, we are, as a countermeasure, focused on Osivelotor entirely on high-performance sites that have a history of delivering great drug development.
當我們調查 OXBRYTA 的一些經驗教訓時,作為對策,我們將 Osivelotor 完全集中在具有出色藥物開發歷史的高性能網站上。
And this will obviously also support a profile.
這顯然也支援設定檔。
So I'm optimistic.
所以我很樂觀。
And as a final end here, please remember that when we did the GBT deal, our eyes were really on Osivelotor, where maybe up to 80% of the value of the deal.
最後,請記住,當我們進行 GBT 交易時,我們的目光實際上集中在 Osivelotor 上,它可能佔交易價值的 80%。
But OXBRYTA allowed early entrance into the market, and we'll continue to investigate OXBRYTA and keep you updated with what we learn.
但 OXBRYTA 允許提前進入市場,我們將繼續調查 OXBRYTA 並向您通報我們了解到的最新情況。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Mikael.
謝謝你,米凱爾。
Next question, please.
請下一個問題。
Operator
Operator
Dave Risinger, Leerink Partners.
戴夫‧瑞辛格 (Dave Risinger),Leerink 合夥人。
Dave Risinger - Analyst
Dave Risinger - Analyst
Yes, thanks very much, and thanks for taking all these questions today.
是的,非常感謝,感謝您今天提出所有這些問題。
So my first question relates to cost cutting ahead.
所以我的第一個問題與提前削減成本有關。
Obviously, the company is already engaged in significant SG&A and R&D efficiency initiatives, but I'm curious about whether management sees opportunities for further SG&A and R&D reductions.
顯然,該公司已經參與了重要的銷售、管理和行政費用和研發效率舉措,但我很好奇管理層是否看到了進一步削減銷售、管理和行政費用和研發的機會。
And then with respect to the over 30-valent pneumococcal conjugate vaccine candidate in pre-clinical development, given management's prior statements about its R&D initiatives, I'm assuming that that will be adjuvanted, and I just wanted to confirm that.
然後,關於臨床前開發中的 30 價以上候選肺炎球菌結合疫苗,考慮到管理層之前關於其研發計劃的聲明,我假設這將得到佐證,我只是想確認這一點。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Let me take quickly, although that's David's domain, the SG&A and R&D.
讓我快速介紹一下,儘管這是 David 的職責範圍,即 SG&A 和 R&D。
Look, we did significant reductions, and we were very careful to make them in a way that will not affect our pipeline and will not affect our business.
看,我們進行了大幅削減,而且我們非常小心地以不會影響我們的管道和業務的方式進行削減。
So we are very happy with what has happened.
所以我們對所發生的事情感到非常高興。
Now are we going to not continue being efficient?
現在我們不再繼續保持高效率了嗎?
Of course we will.
我們當然會。
I think I see tremendous opportunities ahead of us that we can reduce some of the less ROI-driven investments that we are doing, both in R&D and SG&A.
我認為我們看到了巨大的機遇,我們可以減少一些投資報酬率較低的投資,無論是在研發或銷售管理、行政管理方面。
And part of that will be, of course, reinvested in more productive -- with a trend to be able to control the cost and absorb our cost inflation.
當然,其中一部分將用於提高生產力的再投資——趨勢是能夠控製成本並吸收成本通膨。
So you should see a constant, very cost-focused, very cost-conscious culture as we move on.
因此,隨著我們繼續前進,您應該會看到一種持續的、非常注重成本、非常注重成本的文化。
Now, Mikael, on the 30-valent?
現在,Mikael,30 價?
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Mikael Dolsten - Chief Scientific Officer & President, Pfizer Research and Development
Yes, Dave, thank you for a timely question.
是的,戴夫,謝謝你及時提出問題。
And I think we really have been breaking new ground in our PCV technology platforms.
我認為我們確實在 PCV 技術平台上取得了新突破。
And we were obviously very pleased to get some of our new technologies validated with the serotype 3 that you heard about in the fourth generation, the 25-valent.
我們顯然非常高興我們的一些新技術得到了您在第四代 25 價血清型 3 上的驗證。
The components that allows us to go far beyond 30 includes a very sophisticated new type of chemistry that on certain types of serotypes can give several-fold improvement in titer.
使我們能夠遠遠超過 30 種的成分包括一種非常複雜的新型化學物質,這種化學物質對於某些類型的血清型可以使效價提高數倍。
There are minor or more substantial formulation changes that can give some to quite significant fold increase, and that may or may not include adjuvants and also experience that we're gaining on the use of carriers that we haven't been working on in PCV before that can add to this toolbox.
有一些小的或更實質性的配方變化,可以帶來一些相當顯著的倍數增加,並且可能包括也可能不包括佐劑,並且我們還通過使用我們以前沒有在PCV 中研究過的載體獲得了經驗可以加入這個工具箱。
So we are right now bringing all of these data together.
因此,我們現在正在將所有這些數據匯總在一起。
And while we feel we have learned a lot with the adjuvants as seen in our CDP program that allow us to go from three to two and we have a toolbox of new adjuvants, whether it really will be necessary or not, it's too early to tell.
雖然我們覺得我們在CDP 計劃中學到了很多佐劑方面的知識,使我們能夠從三種佐劑變為兩種佐劑,並且我們擁有一個新佐劑工具箱,但無論是否真的有必要,現在判斷還為時過早。
But I acknowledge your good skills in the vaccine technology, and we'll keep you updated as we get closer to selecting candidates.
但我承認您在疫苗技術方面擁有良好的技能,當我們接近選擇候選人時,我們會及時向您通報最新情況。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Okay, next question, please.
好的,請下一個問題。
Operator
Operator
Chris Schott, JPMorgan.
克里斯‧肖特,摩根大通。
Chris Schott - Analyst
Chris Schott - Analyst
Great.
偉大的。
Thanks very much.
非常感謝。
Just two quick ones here.
這裡只有兩個快速的。
Just first on margin structure and following up on the prior question, is a mid to high 30% adjusted kind of operating margin adjusted for COMIRNATY still fair for Pfizer, and what's a rough timeline to get there?
首先是關於利潤率結構,並跟進先前的問題,針對 COMIRNATY 調整的中高 30% 調整後的營業利潤率對輝瑞來說仍然公平嗎?
And then my second question was just on the vepdegestrant max franchise.
然後我的第二個問題是關於 vepdegestrant max 特許經營權。
Obviously, very strong year this year.
顯然,今年非常強勁。
But switching out to next year, we've got the Part D redesign, we've got incremental competition.
但到了明年,我們對 D 部分進行了重新設計,我們迎來了增量競爭。
Is there still enough volume opportunity here to think about this as a franchise that's going to be generating healthy growth, or should we think about growth slowing significantly going forward?
這裡是否仍然有足夠的銷售機會來將其視為將產生健康成長的特許經營權,或者我們是否應該考慮未來成長顯著放緩?
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Dave, you start.
戴夫,你開始吧。
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
So first, obviously, mid to high 30s is very much within the realm of our business model.
首先,顯然,30 多歲的中高年齡層在很大程度上屬於我們的商業模式範圍。
We're very focused against that.
我們非常反對這一點。
We continue to march and make progress against that over time.
隨著時間的推移,我們將繼續前進並取得進展。
So we don't have a specific date for you at this point in time, but as we continue to progress both this year and we give guidance for next year, you should see us progress on that front.
因此,我們目前還沒有為您提供具體日期,但隨著我們今年繼續取得進展並為明年提供指導,您應該會看到我們在這方面取得的進展。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And I think COMIRNATY was also a little bit the question.
我認為COMIRNATY 也是一個問題。
Dave Denton - Chief Financial Officer, EVP
Dave Denton - Chief Financial Officer, EVP
Yes, well, I think COMIRNATY is a down draft to that.
是的,好吧,我認為 COMIRNATY 對此是一個向下的草案。
So obviously, adjusted for the size of that business will be important.
顯然,根據業務規模進行調整非常重要。
But having said that, we continue to make investments in our business such that we're more productive top to bottom, therefore expanding our operating margin profile of the company.
但話雖如此,我們繼續對我們的業務進行投資,以提高我們自上而下的生產力,從而擴大我們公司的營業利潤率。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And we don't want to speak for specific products, the markets, right?
我們不想談論特定的產品、市場,對吧?
Because it's a little bit misleading.
因為它有點誤導。
It depends on multiple things.
這取決於多種因素。
We did it because of the extraordinary circumstances in '22.
我們這樣做是因為22年的特殊情況。
But in general, you all know that from our two products, Paxlovid is very, very high margin and COMIRNATY is on the low.
但總的來說,大家都知道,從我們的兩個產品來看,Paxlovid 的利潤率非常非常高,而 COMIRNATY 的利潤率很低。
VYNDAQEL, why don't we start international this time and then we end up with Aamir on party redesign?
VYNDAQEL,為什麼我們這次不開始國際化,然後我們最終與阿米爾一起重新設計派對?
Alexandre de Germay - Chief International Commercial Officer, EVP
Alexandre de Germay - Chief International Commercial Officer, EVP
Okay, so on the international, we had a very strong year, and we continue to grow very strongly this quarter at 31%.
好的,在國際市場上,我們度過了非常強勁的一年,本季我們繼續以 31% 的速度強勁成長。
Actually, our total patients on treatment have increased by 14% in the third quarter versus the second quarter.
事實上,第三季接受治療的患者總數比第二季增加了 14%。
So this illustrates the fact that we are growing, and we continue to add new patients on treatment.
因此,這說明了我們正在成長的事實,我們不斷增加新的患者接受治療。
This is essentially the result of three things: one, the establishment of VYNDAQEL as a standard of care pretty much in all the countries where we operate; two, the establishment of a robust infrastructure of care, which will enable a faster diagnosis and treatment of this complex disease.
這本質上是三件事的結果:第一,在我們開展業務的所有國家/地區幾乎將 VYNDAQEL 確立為護理標準;第二,建立強大的護理基礎設施,這將有助於更快地診斷和治療這種複雜的疾病。
So this is a complex disease and finding those patients takes time, and now we have a robust infrastructure.
因此,這是一種複雜的疾病,找到這些患者需要時間,現在我們擁有強大的基礎設施。
And the third element is also, of course, the increased access.
當然,第三個要素也是增加存取權限。
Today, we have 45 countries where we have reimbursements.
如今,我們有 45 個國家提供報銷服務。
And we just recently had in this quarter two countries, the UK and Australia, so two significant countries that have started to reimburse VYNDAQEL.
最近,本季有兩個國家,英國和澳大利亞,這兩個重要的國家已開始償還 VYNDAQEL。
So moving forward, we really see that those three elements will continue to deliver and drive growth in the key international markets.
因此,展望未來,我們確實看到這三個要素將繼續推動並推動主要國際市場的成長。
And if you look at the treatment rates in our major international market, we still see some potential to increase that diagnosis.
如果你看看我們主要國際市場的治療率,我們仍然看到增加診斷的一些潛力。
So that will be the drivers of growth in the next few quarters.
因此,這將成為未來幾季的成長動力。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Aamir?
阿米爾?
Aamir Malik - Chief US Commercial Officer, EVP
Aamir Malik - Chief US Commercial Officer, EVP
So Chris, in the US, I'll give you a little bit of color.
所以克里斯,在美國,我會給你一點顏色。
Obviously, VYNDA's had very strong growth this year.
顯然,VYNDA 今年的成長非常強勁。
And I think a big part of that has been just a direct result of the commercial effort and attention that we've put on it, where we've seen real growth in diagnosis rate and new patient starts.
我認為其中很大一部分是我們投入的商業努力和關注的直接結果,我們看到了診斷率和新患者開始的真正成長。
So new patient starts are up about 61% versus last year, and they're up about 3% quarter over quarter as well.
因此,新患者入院數量比去年增加了約 61%,季度較上季也增加了約 3%。
And we're also improving compliance rates significantly with existing patients.
我們也顯著提高了現有患者的依從率。
For the market, there's a lot of patients, nearly half, that remain undiagnosed, so there's significant opportunity there.
對於市場來說,有很多患者(近一半)仍未得到診斷,因此那裡存在巨大的機會。
We will have tailwinds as we go forward, so we continue to put attention on this, and that's going to be largely increased diagnosis education, the prescriber rate that we're growing, as well as affordability conditions, and we've turned the page into 2025.
當我們前進時,我們將有順風車,所以我們繼續關注這一點,這將大大增加診斷教育,我們正在增長的處方者比例,以及負擔能力條件,我們已經翻開了新的一頁到2025年。
But we do think that the volume growth will be at meaningfully lower levels than what we've seen year to date.
但我們確實認為銷量成長將明顯低於我們今年迄今為止所看到的水平。
And a big part of that is obviously headwinds we're going to see from the changing market landscape where we will have new competitive entrants that will impact new patient starts as well as potential switching of existing patients onto some of these options.
其中很大一部分顯然是我們將從不斷變化的市場格局中看到的阻力,我們將有新的競爭者進入,這將影響新患者的開始以及現有患者可能轉向其中一些選擇。
So those are some of the puts and takes on VYNDA.
這些是 VYNDA 的一些看跌和承受。
IRA will be a piece of that as well, as Dave mentioned, and we'll have more to share about 25-specifics when we get guidance.
正如 Dave 所提到的,IRA 也將成為其中的一部分,當我們獲得指導時,我們將分享更多關於 25 個細節的資訊。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Okay.
好的。
And the last question?
最後一個問題?
Operator
Operator
Mohit Bansal, Wells Fargo.
莫希特·班薩爾,富國銀行。
Mohit Bansal - Analyst
Mohit Bansal - Analyst
Great.
偉大的。
Thank you very much for squeezing me in.
非常感謝你把我擠進去。
And first of all, congrats on phenomenal hire in Andrew Baum.
首先,恭喜安德魯·鮑姆 (Andrew Baum) 的出色聘用。
So maybe, taking a step back, can you comment something about ABRYSVO, if there was any stocking in this quarter?
那麼,退一步來說,您能否評論一下 ABRYSVO,本季是否有庫存?
This particular market is a lot like stocking driven in fourth and first quarter, so how you are thinking about that?
這個特殊的市場很像第四季和第一季的庫存驅動,那麼您對此有何看法?
It looks like from the IQVIA trends, price implied, price jumped a lot.
從IQVIA的走勢來看,價格隱含,價格上漲了不少。
So if you could help us understand what is going on there and how should we think about this particular product in coming quarters.
因此,您是否可以幫助我們了解那裡正在發生的事情以及我們在未來幾季應該如何考慮這個特定產品。
Thank you.
謝謝。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Which product it is, Mohit?
莫希特,這是什麼產品?
Mohit Bansal - Analyst
Mohit Bansal - Analyst
ABRYSVO.
阿布里索沃。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
ABRYSVO.
阿布里索沃。
Thank you.
謝謝。
All right.
好的。
Aamir Malik - Chief US Commercial Officer, EVP
Aamir Malik - Chief US Commercial Officer, EVP
So a few comments on ABRYSVO.
關於 ABRYSVO 的一些評論。
So we wanted to, as I mentioned before, really start this vaccination season with ABRYSVO in fridges, in retailers, predominantly where the volume is, as well as with health systems.
因此,正如我之前提到的,我們希望真正開始在冰箱、零售商(主要是有數量的地方)以及衛生系統中使用 ABRYSVO 來開始這個疫苗接種季節。
So we worked with our customers and our channel partners to make sure that we were appropriately stocked, and that's reflected in our Q3 numbers.
因此,我們與客戶和通路合作夥伴合作,確保我們有適當的庫存,這反映在我們的第三季數據中。
Now what we have also seen over the course of Q3 is that administration volumes, and for ABRYSVO, that began in August, over the course of the quarter have continued to steadily rise.
現在我們在第三季也看到,管理量以及從 8 月開始的 ABRYSVO 的管理量在整個季度持續穩定上升。
Now they are at lower volumes than from a market perspective where they were last year.
從市場角度來看,現在的銷售量低於去年。
Lots of reasons for that, including timing of the COVID vaccines, as well as the change in the ACE recommendation.
造成這種情況的原因有很多,包括新冠疫苗的接種時間以及 ACE 建議的變化。
But we anticipate that there will be volumes that continue into the fourth quarter.
但我們預計銷售量將持續到第四季。
And then finally, our results are also a function of what Albert mentioned is our significant improvement in market share.
最後,我們的結果也是阿爾伯特提到的我們市佔率顯著提高的函數。
So we've doubled our market share and customers from wholesalers, and our market share of actual shots in arms, of administrations in the retail setting in the middle of October was at 43%.
因此,我們的市場份額和來自批發商的客戶數量增加了一倍,而且截至 10 月中旬,我們在零售環境中實際投入的市場份額為 43%。
So those are all the dynamics that are going into play for ABRYSVO performance in Q3 and heading into Q4.
這些都是影響 ABRYSVO 在第三季和第四季表現的所有因素。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Aamir.
謝謝你,阿米爾。
And thank you, everyone, for your attention.
謝謝大家的關注。
It was another good quarter for Pfizer.
對輝瑞來說,這又是一個好季度。
I think we are continuing to execute the five-points plan that we have presented at the beginning of the year.
我認為我們正在繼續執行年初提出的五點計劃。
There is an underlying operational health of our business.
我們的業務存在潛在的營運健康狀況。
There is stabilization of the COVID business tool.
新冠疫情業務工具已趨於穩定。
Now we feel comfortable to forecast it.
現在我們可以放心地預測它了。
And we have seen strong growth from the remaining part of the business.
我們看到其餘業務的強勁成長。
We have seen strong performance from new products.
我們看到了新產品的強勁表現。
Most of them, they have beaten analysts' expectations this quarter, which shows that they are doing better at least than what was perceived they would do.
他們中的大多數人本季的表現都超出了分析師的預期,這表明他們的表現至少比人們認為的要好。
And we are looking forward to continuing this path of executing and creating shareholder value.
我們期待繼續這條執行和創造股東價值的道路。
Thank you for your interest in Pfizer and you have a wonderful week.
感謝您對輝瑞的興趣,祝您度過了愉快的一周。
Operator
Operator
That concludes today's call.
今天的電話會議到此結束。
You may disconnect at any time.
您可以隨時斷開連線。