輝瑞 (PFE) 2022 Q3 法說會逐字稿

內容摘要

輝瑞是一家製藥公司,正在尋求推出一種新的母體 RSV 疫苗。這是一個重大突破,因為 RSV 是嬰兒和兒童呼吸道疾病的主要原因。該疫苗有望在不久的將來獲准在美國和歐洲使用。該公司正在尋找對其業務產生重大影響的大型轉型交易。

輝瑞在 2020 年第三季度的強勁增長受到 PAXLOVID 和 COMIRNATY 支出增加以及醫療改革費用增加的推動。調整後的研發費用在運營上也增長了 2%,這是由於對最近收購的資產以及腫瘤學和非 COVID-19 疫苗項目的投資增加。這些增長部分被 COVID-19 預防和治療計劃以及各種後期臨床計劃的支出減少所抵消。

本季度調整後收入的有效稅率為 4.4%,顯著低於典型水平,這得益於與多個稅收管轄區跨多個納稅年度的全球所得稅決議相關的稅收優惠。排除這些稅收決議,基本稅率與歷史趨勢一致。

由於這些強勁的財務業績,輝瑞將其對 2022 年收入的運營預期提高了 17 億美元,調整後的每股攤薄收益增加了 0.19 美元。輝瑞是一家一直專注於開發基於 mRNA 的療法的製藥公司。最近,他們活躍於內科、抗感染、I&I 和腫瘤學領域。他們還在研究呼吸道疫苗和帶狀皰疹疫苗。該公司開局良好,但他們的開支可能是未來的一個問題。

賽諾菲和輝瑞是世界上最大的兩家製藥公司,它們都在研究潛在的 COVID-19 疫苗。賽諾菲(Sanofi)計劃專注於 RSV 抗體,而輝瑞(Pfizer)計劃專注於科學基質。文本討論了為可能開藥或配藥的人提供的教育和培訓。提到超過 500,000 名醫生為藥物開具處方,超過 80,000 名藥劑師接受瞭如何配藥的培訓。

Arvinas 的首席執行官 John Houston 被問及他們計劃將藥物開發計劃擴展到目前專注於癌症之外的其他治療領域的計劃。他回答說他們正在考慮其他領域,例如神經病學和炎症,但腫瘤學是他們目前的主要關注點。他還提到,他們正在研究其 mRNA 技術的其他應用,例如個性化癌症疫苗,但目前沒有具體計劃來追求這一點。

然後,本文討論了一項關於藥物 PAXLOVID 對 COVID-19 高危患者影響的研究結果。研究發現,PAXLOVID 與 ICU 入院率降低 100%,住院患者機械通氣降低 100%,氧氣支持和 COVID-19 相關住院治療分別降低 82% 和 86% 相關。該研究還發現,PAXLOVID 與任何與 COVID-19 相關的就診次數減少 73% 有關。

文中還討論了最近的一項研究,該研究發現接受安慰劑的患者中有 1/3 在症狀緩解後出現症狀復發,這表明反彈是一種與 COVID 相關的現象,而不是與 PAXLOVID 相關的現象。輝瑞是一家大型製藥公司,由於其排名第一的市場份額地位和未來的預期增長,它在美國取得了成功。該公司最近收購了 Biohaven,這為他們提供了三種藥物的組合,這些藥物可以在偏頭痛市場產生超過 60 億美元的年銷售額。此外,公司正致力於開發一種新藥依曲莫德,該藥物正處於 III 期臨床試驗階段。如果獲得批准,該藥物將用於治療潰瘍性結腸炎。該公司對 etrasimod 的潛力持樂觀態度,並認為它可能成為重磅藥物。

輝瑞公司首席執行官阿爾伯特·布爾拉(Albert Bourla)最近受到分析師關於公司第四季度收益的質疑。一位分析師特別詢問了有關 Prevnar 疫苗與兒科相關的數據。 Bourla 解釋說,隨著輝瑞公司與美國政府合作接管疫苗的分銷,目前正處於過渡期。他接著說,根據臨床試驗的數據,該公司對疫苗的功效充滿信心。

首席執行官的解釋滿足了分析師關於核心增長的問題,第三季度的運營增長為 2%。核心增長不包括真正與 COVID 相關的合同製造業務。醫藥業務的增長為 4%,不包括 COVID 和合同製造。 5年復合年增長率為6%。因此,CEO 認為這是一個可持續的數字。

輝瑞是一家大型製藥公司,其產品組合中有許多重磅藥物。由於其排名第一的市場份額地位和未來的預期增長,該公司在美國取得了成功。最近,輝瑞收購了 Biohaven,這為他們提供了三種藥物的組合,這些藥物可以在偏頭痛市場產生超過 60 億美元的年銷售額。此外,公司正致力於開發一種新藥依曲莫德,該藥物正處於 III 期臨床試驗階段。如果獲得批准,該藥物將用於治療潰瘍性結腸炎。該公司對 etrasimod 的潛力持樂觀態度,並認為它可能成為重磅藥物。

輝瑞公司首席執行官阿爾伯特·布爾拉(Albert Bourla)最近受到分析師關於公司第四季度收益的質疑。一位分析師特別詢問了有關 Prevnar 疫苗與兒科相關的數據。 Bourla 解釋說,隨著輝瑞公司與美國政府合作接管疫苗的分銷,目前正處於過渡期。他接著說,根據臨床試驗的數據,該公司對疫苗的功效充滿信心。

首席執行官的解釋滿足了分析師關於核心增長的問題,第三季度的運營增長為 2%。核心增長不包括真正與 COVID 相關的合同製造業務。醫藥業務的增長為 4%,不包括 COVID 和合同製造。 5年復合年增長率為6%。因此,CEO 認為這是一個可持續的數字。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day, everyone, and welcome to Pfizer's Third Quarter 2022 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chris Stevo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.

    大家好,歡迎參加輝瑞公司 2022 年第三季度收益電話會議。今天的電話正在錄音。此時,我想將電話轉給高級副總裁兼首席投資者關係官 Chris Stevo 先生。請繼續,先生。

  • Christopher J. Stevo - Senior VP & Chief IR Officer

    Christopher J. Stevo - Senior VP & Chief IR Officer

  • Good morning. Welcome to Pfizer's third quarter earnings call. We anticipate that this call will last 60 minutes. I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Dave Denton, our CFO; and Dr. Mikael Dolsten, President of Worldwide Research and Development and Medical. Joining for the Q&A session, we will also have Angela Hwang, Chief Commercial Officer and President, Global Biopharmaceuticals Business; Aamir Malik, our Chief Business Innovation Officer; Dr. William Pao, our Chief Development Officer; and Doug Lankler, our General Counsel.

    早上好。歡迎來到輝瑞第三季度財報電話會議。我們預計此通話將持續 60 分鐘。今天,我們的董事長兼首席執行官 Albert Bourla 博士加入了我的行列;我們的首席財務官 Dave Denton;以及全球研發和醫療總裁 Mikael Dolsten 博士。參加問答環節的還有首席商務官兼全球生物製藥業務總裁 Angela Hwang;我們的首席業務創新官 Aamir Malik;我們的首席開發官鮑威廉博士;和我們的總法律顧問 Doug Lankler。

  • Before we begin the call, I'm also happy to announce that we will host an Analyst Day in New York City on the afternoon of December 12. Members of our executive team and other leaders of Pfizer will share information on our rich slate of potential near-term product launches and the R&D readouts which will drive the next wave of product launches after that, both of which will support our 2030 revenues and beyond. In-person attendance will be by invitation, but we will also be webcasting the event. While we're not going to talk more about the agenda today, we look forward to providing more details as we get closer to December 12.

    在開始電話會議之前,我也很高興地宣布,我們將於 12 月 12 日下午在紐約市舉辦分析師日活動。我們的執行團隊成員和輝瑞的其他領導人將分享有關我們豐富潛力的信息近期產品發布和研發讀數將推動下一波產品發布,這兩者都將支持我們 2030 年及以後的收入。將通過邀請親自出席,但我們也將通過網絡直播該活動。雖然我們今天不會更多地討論議程,但我們期待在接近 12 月 12 日時提供更多細節。

  • Materials for this call and other earnings-related materials are on the Investor Relations section of pfizer.com. Please see our forward-looking statements disclaimer on Slide 4. And additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and in our SEC forms 10-K and 10-Q under Risk Factors and Forward-looking Information and Factors That May Affect Future Results. 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 these statements.

    本次電話會議的材料和其他與收益相關的材料位於 pfizer.com 的投資者關係部分。請在幻燈片 4 上查看我們的前瞻性聲明免責聲明。有關這些聲明和我們的非公認會計原則財務指標的更多信息可在我們的收益發布和我們的 SEC 表格 10-K 和 10-Q 中的風險因素和前瞻性可能影響未來結果的信息和因素。關於電話會議的前瞻性陳述受到重大風險和不確定性的影響,僅在電話會議的原始日期發表,我們不承擔更新或修改任何這些陳述的義務。

  • With that, I will turn the call over to Albert.

    有了這個,我會把電話轉給阿爾伯特。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Chris. Hello, everyone, and thank you for joining us today. I will briefly touch on some recent highlights. I will then spend the bulk of my time speaking to our expectations for what we feel will be a promising and prosperous future for Pfizer and the patients we serve.

    謝謝你,克里斯。大家好,感謝您今天加入我們。我將簡要談談最近的一些亮點。然後,我將花費大部分時間談論我們對輝瑞和我們所服務的患者的美好未來的期望。

  • In addition to generating a stellar financial performance, since our last earnings call, we reported positive pivotal data for several exciting pipeline programs, including our RSV vaccine candidate for older adults, Prevnar 20 for children, the potential combination of treatment of TALZENNA and XTANDI in men with metastatic castration-resistant prostate cancer, our pentavalent meningococcal vaccine candidate for adolescents and young adults, as well as exciting progress for our GLP-1 program in type 2 diabetes and obesity.

    除了產生出色的財務業績外,自上次財報電話會議以來,我們報告了幾個令人興奮的管道項目的積極關鍵數據,包括我們用於老年人的 RSV 候選疫苗、用於兒童的 Prevnar 20、TALZENNA 和 XTANDI 治療的潛在組合患有轉移性去勢抵抗性前列腺癌的男性,我們用於青少年和年輕人的五價腦膜炎球菌疫苗候選者,以及我們在 2 型糖尿病和肥胖症方面的 GLP-1 計劃令人興奮的進展。

  • Just this morning, we announced positive top line data from the Phase III clinical trial investigating our bivalent RSV vaccine candidate when administered to pregnant participants to help protect their infants from RSV disease after birth.

    就在今天早上,我們宣布了 III 期臨床試驗的積極頂線數據,該試驗研究了我們的二價 RSV 候選疫苗,該疫苗用於懷孕參與者以幫助保護他們的嬰兒在出生後免受 RSV 疾病的侵害。

  • We established a new commercial structure within our global biopharmaceutical business that is focused on 3 broad therapeutic areas: primary care, specialty care and oncology. We believe this new structure will enable us to maximize the commercial success of the multiple exciting product launches, including several potential blockbusters that are poised to emerge from our scientific pipeline over the next few years.

    我們在全球生物製藥業務中建立了一個新的商業結構,專注於 3 個廣泛的治療領域:初級保健、專科保健和腫瘤學。我們相信,這種新結構將使我們能夠最大限度地提高多個令人興奮的產品發布的商業成功,其中包括準備在未來幾年從我們的科學管道中出現的幾個潛在的重磅炸彈。

  • We have continued to advance potentially game-changing vaccines in the fight against respiratory disease by entering into a Phase III study for our mRNA flu vaccine candidate and initiating a Phase I study for a vaccine candidate that combines our mRNA flu and COVID-19 vaccine in one shot.

    我們通過對我們的 mRNA 流感疫苗候選者進行 III 期研究並開始對結合了我們的 mRNA 流感和 COVID-19 疫苗的候選疫苗進行 I 期研究,從而繼續推進可能改變遊戲規則的疫苗,以對抗呼吸道疾病。一槍。

  • We completed the acquisitions of Biohaven Pharmaceuticals and Global Blood Therapeutics, giving us market-leading franchises in both migraine and sickle cell disease, respectively.

    我們完成了對 Biohaven Pharmaceuticals 和 Global Blood Therapeutics 的收購,分別為我們在偏頭痛和鐮狀細胞病方面提供了市場領先的特許經營權。

  • Less than 6 months ago after launching An Accord for a Healthier World, a breakthrough initiative designed to close the health equity gap for 1.2 billion people living in 45 lower-income countries, I'm proud to say that the first shipments of our products have arrived to these countries, and we are working with governments on health system improvements that can help make sure these products reach those in need.

    不到 6 個月前,在發起了一項旨在縮小生活在 45 個低收入國家的 12 億人的健康公平差距的“健康世界協議”之後不到 6 個月,我很自豪地說,我們的第一批產品已經到達這些國家,我們正在與政府合作改善衛生系統,以幫助確保這些產品到達有需要的人手中。

  • And of course, we continue to lead the fight against COVID-19. Most notably, our Omicron-adapted bivalent COVID-19 vaccine has been authorized by the U.S. Food and Drug Administration, by the European Medicines Agency and several other regulatory bodies. And as part of Pfizer's commitment to providing equitable access to COVID-19 oral treatments, we agreed to supply at a not-for-profit price up to 6 million PAXLOVID treatment courses to the Global Fund for low and lower middle income countries.

    當然,我們將繼續領導與 COVID-19 的鬥爭。最值得注意的是,我們的 Omicron 適應型二價 COVID-19 疫苗已獲得美國食品和藥物管理局、歐洲藥品管理局和其他幾個監管機構的授權。作為輝瑞 (Pfizer) 提供公平獲得 COVID-19 口服治療的承諾的一部分,我們同意以非營利價格向低收入和中低收入國家全球基金提供多達 600 萬個 PAXLOVID 治療課程。

  • An exciting quarter, for sure. But in our company and our industry, it's all about what's next. The next breakthrough medicine or vaccine, the next game-changing, the next solution to an unmet patient need. This continued pursuit of what's next is embedded in Pfizer's DNA and the foundational driver of our purpose: breakthroughs that change patients' lives. It's also why we have confidence that Pfizer's story is a story of growth.

    一個令人興奮的季度,當然。但在我們公司和我們的行業中,一切都與下一步有關。下一個突破性藥物或疫苗,下一個改變遊戲規則,下一個解決未滿足患者需求的解決方案。這種對未來的持續追求植根于輝瑞的 DNA 和我們目標的基本驅動力:改變患者生活的突破。這也是為什麼我們有信心輝瑞的故事是一個成長的故事。

  • We recognize that some are questioning Pfizer's longer-term growth projects, particularly in the '25 to '30 time frame. That's understandable given that we currently expect a negative impact of approximately $17 billion in revenues from losses of exclusivity during that period based on our internal calculations. We believe we not only can overcome these expected declines but also can potentially generate strong growth through the end of the decade.

    我們認識到,有些人質疑輝瑞的長期增長項目,尤其是在 25 到 30 年的時間範圍內。這是可以理解的,因為根據我們的內部計算,我們目前預計在此期間失去獨家經營權將產生約 170 億美元的收入負面影響。我們相信,我們不僅可以克服這些預期的下降,還可以在本世紀末實現強勁增長。

  • Let's take a closer look on how we expect to accomplish this. Our strong capital position has given us the ability to pursue business development opportunities with the potential, if successful, of course, to add at least $25 billion of risk-adjusted revenues to our 2030 top line expectations.

    讓我們仔細看看我們希望如何實現這一點。我們強大的資本狀況使我們有能力尋求具有潛力的業務發展機會,如果成功,當然可以為我們的 2030 年收入預期增加至少 250 億美元的風險調整收入。

  • We believe the deals we have already done for Arena, Biohaven, Global Blood Therapeutics and ReViral have the potential to get us more than 1/3 of the way there and that we have more than enough capital to invest in the additional opportunities needed to meet or exceed this target.

    我們相信,我們已經為 Arena、Biohaven、Global Blood Therapeutics 和 ReViral 完成的交易有可能讓我們完成超過 1/3 的目標,並且我們有足夠的資本投資於滿足所需的額外機會或超過這個目標。

  • Perhaps even more exciting is the wave of potential growth drivers emerging from our R&D pipeline in the near term. Over the next 18 months, we expect to have up to 19 new products or indications in the market, including the 5 for which we have already begun co-promotions or commercialization earlier this year. We can find -- you can find the list of these launches in the appendix of the presentation we posted today for this earnings call.

    也許更令人興奮的是短期內從我們的研發管道中湧現出的潛在增長動力浪潮。在接下來的 18 個月中,我們預計市場上將有多達 19 種新產品或適應症,其中包括今年早些時候我們已經開始聯合促銷或商業化的 5 種。我們可以找到——你可以在我們今天為這次財報電話會議發布的演示文稿的附錄中找到這些發布的列表。

  • If successful, these 19 launches, of which more than 2/3 have the potential to be blockbusters, will be the most ever in Pfizer's history. The 15 in-house-developed projects alone could potentially represent approximately $20 billion in 2030 sales, which would more than offset the expected LOE impact.

    如果成功,這 19 次發射(其中超過 2/3 有可能成為重磅炸彈)將是輝瑞歷史上最多的一次。僅 15 個內部開發的項目在 2030 年的銷售額就可能達到約 200 億美元,這將遠遠抵消預期的 LOE 影響。

  • Many of these programs are already largely de-risked from a clinical perspective. The majority of them were discovered in-house and nearly all of them would be for indications outside of COVID-19. If approved, we expect each of these to be key contributors to our growth aspirations through 2025 and beyond.

    從臨床角度來看,其中許多項目已經在很大程度上降低了風險。其中大多數是在內部發現的,幾乎所有這些都將用於 COVID-19 以外的適應症。如果獲得批准,我們預計每一項都將成為我們到 2025 年及以後的增長願景的關鍵貢獻者。

  • And of course, we have many more potential vaccines and medicines in our pipeline with numerous launches expected in the '24 to '30 time line. These include gene therapy candidates for hemophilia A, B and Duchenne muscular dystrophy; our oral GLP-1 for diabetes and obesity; a potential combo vaccine that would cover flu and COVID in one shot and many, many more.

    當然,我們還有更多潛在的疫苗和藥物在我們的管道中,預計在 24 到 30 年的時間線內會推出大量產品。其中包括血友病 A、B 和 Duchenne 肌營養不良的基因治療候選者;我們用於糖尿病和肥胖症的口服 GLP-1;一種潛在的組合疫苗,可以一次性覆蓋流感和 COVID,還有很多很多。

  • With regard to our COVID-19 products, while their sales may fall from our expected 2022 levels of approximately combined $55 billion, we believe our COVID-19 franchises will remain multibillion-dollar revenue generators for the foreseeable future which should serve as a buffer for any unforeseen challenges with other products in our portfolio.

    關於我們的 COVID-19 產品,雖然它們的銷售額可能會低於我們預計的 2022 年約 550 億美元的總水平,但我們相信,在可預見的未來,我們的 COVID-19 特許經營權仍將是數十億美元的收入來源,這應該可以作為緩衝我們產品組合中其他產品的任何不可預見的挑戰。

  • Our confidence to execute this plan stems from the depth of our financial resources and the firepower it gives us to pursue business development opportunities, the powerful brand equity we have built up over the past 170 years and further enhanced in the past 2 years. According to a recent survey, our brand awareness now stands at an impressive 82% and our favorability stands at 61% compared with 42% for the industry as a whole, results that were obtained just a couple of months ago.

    我們執行此計劃的信心來自於我們深厚的財務資源和它賦予我們尋求業務發展機會的火力,以及我們在過去 170 年中建立並在過去兩年中進一步增強的強大品牌資產。根據最近的一項調查,我們的品牌知名度現在達到了令人印象深刻的 82%,我們的好感度達到了 61%,而整個行業的好感度為 42%,這是幾個月前獲得的結果。

  • And of course, the strength of the 3 foundational pillars of our company, our world-class scientific, our world-class commercial and our world-class manufacturing engines, and you will see on this slide some highlights of each one of them.

    當然,我們公司的 3 個基礎支柱的實力,我們世界級的科學引擎、世界級的商業引擎和世界級的製造引擎,您將在這張幻燈片上看到每一個的一些亮點。

  • Let me now briefly highlight 3 potential blockbusters that we expect to contribute to our long-term growth. RSV is an area of significant unmet need, particularly in older adults and infants. Each year, it is estimated more than 177,000 older adults are hospitalized and 14,000 of them die in the U.S. alone due to RSV that is confirmed by a diagnostic test. We believe we have the potential to be a leader in this space and have a real impact on public health.

    現在讓我簡要強調 3 個我們期望為我們的長期增長做出貢獻的潛在重磅炸彈。 RSV 是一個嚴重需求未得到滿足的領域,特別是在老年人和嬰兒中。據估計,每年有超過 177,000 名老年人住院,其中僅在美國就有 14,000 人死於 RSV,診斷測試證實了這一點。我們相信我們有潛力成為這一領域的領導者,並對公共衛生產生真正的影響。

  • On March 24 of this year, the FDA granted breakthrough designation for our RSV vaccine candidate for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older. We are excited to report positive top line data from the Phase III RENOIR trial in late August, with the recent presentation of detailed results at IDWeek 22.

    今年 3 月 24 日,FDA 授予我們的 RSV 候選疫苗突破性指定,用於預防 60 歲或以上人群由 RSV 引起的下呼吸道疾病。我們很高興在 8 月下旬報告第三階段 RENOIR 試驗的積極頂線數據,最近在 IDWeek 22 上展示了詳細結果。

  • A preplanned interim analysis showed vaccine efficacy of 67% against RSV-associated lower respiratory tract illness, defined by 2 or more symptoms. And vaccine efficacy of 85.7% was observed in participants with more severe disease, presenting 3 or more RSV-associated symptoms of lower respiratory tract illness.

    一項預先計劃的中期分析顯示,疫苗對 RSV 相關下呼吸道疾病(由 2 種或更多症狀定義)的效力為 67%。在患有更嚴重疾病、出現 3 種或更多 RSV 相關下呼吸道疾病症狀的參與者中觀察到疫苗的有效性為 85.7%。

  • We are also excited about the potential for our maternal RSV vaccine candidate. Globally, each year, RSV sickens more than 6.5 million infants under 6 months old and kills approximately 45,000. As announced this morning, our maternal RSV study met the success criterion for 1 of the 2 primary endpoints. Vaccine efficacy of 81.8% was observed against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life. And high efficacy of 69.4% was demonstrated through the first 6 months of life.

    我們也對我們的母體 RSV 候選疫苗的潛力感到興奮。在全球範圍內,RSV 每年導致超過 650 萬 6 個月以下的嬰兒患病並導致大約 45,000 人死亡。正如今天上午宣布的那樣,我們的母體 RSV 研究滿足了 2 個主要終點中的 1 個的成功標準。在嬰兒從出生到生命的前 90 天期間,觀察到疫苗對因 RSV 引起的嚴重下呼吸道疾病的治療效果為 81.8%。在生命的前 6 個月中證明了 69.4% 的高效率。

  • So there is the potential that, subject to regulatory approval, by late 2023, early 2024, we could have the only RSV maternal vaccine in the market, along with an RSV vaccine for older adults, that has high efficacy, and it is well tolerated with no safety concerns.

    因此,在獲得監管部門批准的情況下,到 2023 年底、2024 年初,我們有可能擁有市場上唯一的 RSV 母體疫苗,以及針對老年人的 RSV 疫苗,該疫苗具有高效且耐受性良好沒有安全問題。

  • Combined, the 2 indications represent a potential multibillion-dollar peak revenue opportunity if approved, especially with our highly respected primary care sales force executing these launches.

    如果獲得批准,這兩個跡象表明潛在的數十億美元的峰值收入機會,尤其是在我們備受推崇的初級保健銷售團隊執行這些發布的情況下。

  • Including the RSV antiviral investigational candidates we acquired with ReViral, we aim to have end-to-end solutions with both preventative vaccines and therapeutics to treat those infected with RSV.

    包括我們通過 ReViral 獲得的 RSV 抗病毒研究候選藥物,我們的目標是提供端到端的解決方案,包括預防性疫苗和治療劑來治療那些感染 RSV 的人。

  • Ulcerative colitis or UC is a chronic and often debilitating inflammatory bowel disease that affects an estimated 1 million people in the U.S. alone. Many patients living with this disease never achieve or maintain remission, and physicians are seeking effective, proven oral therapies with a favorable benefit/risk profile that can be an attractive first-line advanced therapy option. As a result, we expect the market opportunity to grow by about 50% over the next 5 years.

    潰瘍性結腸炎或 UC 是一種慢性且經常使人衰弱的炎症性腸病,僅在美國就影響了大約 100 萬人。許多患有這種疾病的患者從未達到或維持緩解,醫生正在尋求有效的、經過驗證的口服療法,具有有利的收益/風險特徵,這可能是一種有吸引力的一線先進治療選擇。因此,我們預計未來 5 年市場機會將增長約 50%。

  • The positive Phase III data from the ELEVATE UC 12 and 52 trials reinforce our belief that etrasimod has a differentiated clinical profile and can be an important treatment option if approved. We believe that etrasimod can be a multibillion-dollar blockbuster product. We expect to launch the product in the U.S. as soon as the second half of 2023, pending regulatory approval, through our specialty care sales force, which already has strong relationships in the UC market, thanks to its work with Xeljanz, biosimilars, et cetera.

    來自 ELEVATE UC 12 和 52 試驗的積極 III 期數據強化了我們的信念,即依曲莫德具有差異化的臨床特徵,如果獲得批准,可以成為重要的治療選擇。我們相信 etrasimod 可以成為價值數十億美元的重磅產品。我們預計最早在 2023 年下半年通過我們的專業護理銷售團隊在美國推出該產品,等待監管部門的批准,這要歸功於其與 Xeljanz、生物仿製藥等的合作.

  • Lastly, let's look at migraine. Following our acquisition of Biohaven in early October, we are now aiming to build the world's leading global migraine franchise with the potential to impact 1 billion patients around the world. Migraine is a debilitating disease and has 11.6% prevalence worldwide. In the U.S. alone, there are 40 million patients with migraine, and 1 out of 5 women are migraine sufferers right now. The economic burden is significant at $36 billion per year. We believe our portfolio, including NURTEC ODT, VYDURA and zavegepant, could meet a range of needs in the market, allowing physicians and patients to decide how to appropriately manage migraine treatment and prevention. As a result, we see the potential to reach more than $6 billion in peak revenues altogether.

    最後,讓我們看看偏頭痛。在 10 月初收購 Biohaven 之後,我們現在的目標是建立世界領先的全球偏頭痛特許經營權,並有可能影響全球 10 億患者。偏頭痛是一種使人衰弱的疾病,全球患病率為 11.6%。僅在美國,就有 4000 萬偏頭痛患者,目前每 5 名女性中就有 1 名患有偏頭痛。每年的經濟負擔高達 360 億美元。我們相信我們的產品組合,包括 NURTEC ODT、VYDURA 和 zavegepant,可以滿足市場的一系列需求,讓醫生和患者能夠決定如何適當地管理偏頭痛的治療和預防。因此,我們看到了總共達到超過 60 億美元的峰值收入的潛力。

  • In the U.S., NURTEC is growing very well, including the impact of Pfizer's co-promoting, which began in August pre-close. NURTEC has further strengthened its #1 market share position in the oral CGRP market, and we expect even stronger growth as we deliver on our promise to further enhance our commercial efforts behind this program.

    在美國,NURTEC 的增長非常好,包括輝瑞公司聯合推廣的影響,該聯合推廣始於 8 月收盤前。 NURTEC 進一步加強了其在口服 CGRP 市場的第一市場份額地位,我們預計隨著我們兌現進一步加強該計劃背後的商業努力的承諾,將實現更強勁的增長。

  • Outside the U.S., it has been approved in the EU, U.K., Israel, Kuwait, United Arab Emirates and we have filed for registration in an additional 10 markets. While this is not a new product launch, we believe this is a great example of how we can take this portfolio to new heights by leveraging the full strength of Pfizer's global commercial engine, including in primary care physicians.

    在美國以外,它已在歐盟、英國、以色列、科威特、阿拉伯聯合酋長國獲得批准,我們已在另外 10 個市場申請註冊。雖然這不是一個新產品的發布,但我們相信這是一個很好的例子,說明我們如何利用輝瑞全球商業引擎的全部實力,包括初級保健醫生,將這個產品組合提升到新的高度。

  • Moving over to zavegepant. We recently expect to launch zavegepant intranasal in the U.S. next year, pending FDA approval, and we plan to globally commercialize. Lastly, the oral prevention Phase III trial is ongoing with a data readout expected in the third quarter.

    轉到zavegepant。我們最近預計明年將在美國推出 zavegepant 鼻內給藥,等待 FDA 批准,我們計劃在全球範圍內商業化。最後,口腔預防 III 期試驗正在進行中,預計將在第三季度公佈數據。

  • So with that, I turn it over to Dave to update you on the results and outlook for the financials. After Dave, Mikael will speak about the progression of our pipeline.

    因此,我把它交給戴夫,讓你了解財務結果和前景。在 Dave 之後,Mikael 將談論我們管道的進展情況。

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Thank you, Albert, and good morning. I'll begin this morning with a few comments regarding how the company continues to deploy capital in a disciplined manner in support of long-term growth and, importantly, enhanced shareholder returns. As you know, Pfizer's cash generation capabilities has expanded significantly over the past several years and the efficient deployment of this capital is more critical than ever.

    謝謝你,阿爾伯特,早上好。今天早上,我將首先就公司如何繼續以有紀律的方式部署資本以支持長期增長以及重要的是提高股東回報發表一些評論。如您所知,輝瑞的現金生成能力在過去幾年中顯著擴大,而有效部署這筆資金比以往任何時候都更加重要。

  • During the first 9 months of 2022, the company has deployed and committed capital in 3 main areas: first, we've invested $7.8 billion in internal R&D as we continue to support our growing pipeline of innovative medicines. These investments are squarely focused on driving revenue growth through 2030.

    在 2022 年的前 9 個月,公司在 3 個主要領域部署並承諾了資本:首先,我們在內部研發上投資了 78 億美元,因為我們繼續支持我們不斷增長的創新藥物管道。這些投資的重點是推動到 2030 年的收入增長。

  • Secondly, in the first 3 quarters of this year, we have invested approximately $8 billion in completed business transactions. Additionally, early in the fourth quarter, the company completed investments of more than $18 billion in transactions, including both Biohaven and GBT, which brings us to approximately $26 billion in capital deployed for business development transactions thus far in 2022 alone. These transactions illustrate our progress towards the goal of adding $25 billion in risk-adjusted 2030 revenues through BD.

    其次,今年前 3 季度,我們在已完成的商業交易中投入了約 80 億美元。此外,在第四季度初,該公司完成了超過 180 億美元的交易投資,包括 Biohaven 和 GBT,這使我們僅在 2022 年迄今為止就為業務發展交易部署了約 260 億美元的資本。這些交易說明了我們在通過 BD 實現 2030 年風險調整後收入增加 250 億美元的目標方面取得的進展。

  • And finally, we have returned nearly $9 billion of capital to shareholders through a combination of both dividends and value-enhancing share repurchases.

    最後,我們通過股息和增值股票回購相結合,向股東返還了近 90 億美元的資本。

  • Clearly, maximizing shareholder value through prudent capital allocation will continue to be a major focus for Pfizer. So with that, let me briefly review our financial results for the quarter. I'll limit my remarks largely to adjusted and operating growth figures.

    顯然,通過審慎的資本配置實現股東價值最大化將繼續成為輝瑞的主要關注點。因此,讓我簡要回顧一下我們本季度的財務業績。我將主要將我的評論限制在調整後的運營增長數據上。

  • Third quarter revenues demonstrated strength across many areas of the business, but much of that strength was somewhat obscured by our incredibly strong performance in the third quarter of 2021. Given the strength in the prior year, revenues this quarter decreased 2% operationally. However, looking at it on a 2-year basis, revenues this quarter were up more than 120% compared to the third quarter of 2020. The slight decrease compared to last year was in line with our expectations given the phasing of scheduled deliveries of COMIRNATY, which we discussed in our earnings call last quarter. Also underlying our results this quarter was the strong performance of PAXLOVID as well as continued strength from a number of our other key products.

    第三季度的收入在業務的許多領域都表現出強勁的勢頭,但我們在 2021 年第三季度令人難以置信的強勁表現掩蓋了這種優勢。鑑於去年的強勁勢頭,本季度的運營收入下降了 2%。然而,從 2 年的時間來看,本季度的收入與 2020 年第三季度相比增長了 120% 以上。鑑於 COMIRNATY 計劃交付的階段性,與去年相比略有下降符合我們的預期,我們在上個季度的財報電話會議中討論了這一點。我們本季度業績的另一個基礎是 PAXLOVID 的強勁表現以及我們其他一些關鍵產品的持續實力。

  • Excluding direct sales and alliance revenues related to the COVID products, Pfizer's revenues grew 2% operationally in the quarter. Gross margins expanded by 1,450 basis points versus the third quarter of LY. This improvement is largely due to increased sales of higher-margin PAXLOVID and decreased sales of lower-gross margin COMIRNATY compared to last year. These improvements were partially offset by the impact of a $400 million charge related to excess raw materials for PAXLOVID. Given the unpredictable nature of the virus, we intentionally chose to order additional stock to ensure we can meet any global health demand if an extreme need were to arise.

    不包括與 COVID 產品相關的直接銷售和聯盟收入,輝瑞公司本季度的運營收入增長了 2%。與 LY 第三季度相比,毛利率擴大了 1,450 個基點。這種改善主要是由於與去年相比,利潤率較高的 PAXLOVID 的銷售額增加,而毛利率較低的 COMIRNATY 的銷售額下降。這些改進部分被與 PAXLOVID 過剩原材料相關的 4 億美元費用的影響所抵消。鑑於該病毒的不可預測性,我們有意選擇訂購更多庫存,以確保在出現極端需求時能夠滿足任何全球衛生需求。

  • Adjusted SI&A expenses in the third quarter grew 23% operationally. The increase was primarily driven by spending for PAXLOVID and COMIRNATY and higher health care reform fees.

    第三季度調整後的 SI&A 費用在運營上增長了 23%。這一增長主要是由 PAXLOVID 和 COMIRNATY 的支出以及更高的醫療改革費用推動的。

  • The 2% operational increase in adjusted R&D expense in Q3 was primarily driven by increased cost to develop recently acquired assets as well as investments for certain oncology and non-COVID-19 vaccines programs. This was partially offset by lower spending on programs to prevent and treat COVID-19 and various late-stage clinical programs.

    第三季度調整後的研發費用增長了 2%,主要是由於開發最近收購的資產的成本增加以及對某些腫瘤學和非 COVID-19 疫苗項目的投資。這部分被用於預防和治療 COVID-19 的項目和各種後期臨床項目的支出減少所抵消。

  • The effective tax rate on adjusted income in the quarter was 4.4%, significantly lower than typical, driven by tax benefits related to global income tax resolutions in multiple tax jurisdictions spanning several tax years. Excluding these tax resolutions, the underlying tax rate was consistent with historical trends.

    本季度調整後收入的有效稅率為 4.4%,顯著低於典型水平,這得益於與多個稅收管轄區跨多個納稅年度的全球所得稅決議相關的稅收優惠。排除這些稅收決議,基本稅率與歷史趨勢一致。

  • As a result, reported diluted earnings per share of $1.51 grew by 6%, while adjusted diluted earnings per share of $1.78 grew 44% on an operational basis in the quarter.

    結果,報告的稀釋後每股收益為 1.51 美元,增長了 6%,而調整後的稀釋後每股收益為 1.78 美元,在本季度的運營基礎上增長了 44%。

  • Now foreign exchange movements continue to dampen our results, negatively impacting revenues by approximately $950 million and adjusted diluted earnings per share by $0.05 this quarter.

    現在外匯波動繼續抑制我們的業績,對本季度收入產生約 9.5 億美元的負面影響,調整後的每股攤薄收益減少 0.05 美元。

  • Now let me move to our updated 2022 guidance. Given our strong third quarter performance and our improving outlook for the year, we are increasing our operational expectations for revenues by $1.7 billion and adjusted diluted earnings per share by $0.19. This operational increase on the bottom line would have been even higher if not for an incremental $0.06 negative impact due to higher acquired IPR&D expenses.

    現在讓我轉到我們更新的 2022 年指南。鑑於我們強勁的第三季度業績和我們對今年前景的改善,我們將收入的運營預期提高了 17 億美元,調整後的攤薄每股收益提高了 0.19 美元。如果不是由於更高的獲得的 IPR&D 費用而增加了 0.06 美元的負面影響,那麼底線的運營增長會更高。

  • Partially offsetting these operational increases is the impact of additional strengthening of the U.S. dollar since we last updated guidance in late July. Incremental foreign exchange movements negatively impacted our expectations for 2022 revenues and adjusted diluted earnings per share by $700 million and $0.09, respectively.

    自我們上一次在 7 月底更新指引以來,美元進一步走強的影響部分抵消了這些運營增長。外匯波動的增加對我們對 2022 年收入的預期產生了負面影響,調整後的每股攤薄收益分別為 7 億美元和 0.09 美元。

  • The net impact of these cross-currents result in increases to the midpoints of our revenue and adjusted diluted earnings per share guidance ranges. These revised ranges reflect operational growth rates of 31% for revenues and 70% for adjusted diluted earnings per share at the midpoint compared to 2021. And this was up from our previous operational growth expectations for revenues and adjusted diluted earnings per share of 29% and 65%, respectively.

    這些交叉流的淨影響導致我們收入的中點和調整後的稀釋每股收益指導範圍增加。與 2021 年相比,這些修訂後的範圍反映了 31% 的收入運營增長率和 70% 的調整後攤薄每股收益。這高於我們之前對收入的運營增長預期和調整後的攤薄每股收益 29% 和分別為 65%。

  • Regarding our COVID-19-related revenues, we now expect the vaccine revenue for the year to be approximately $34 billion, up by $2 billion compared to our prior guidance. For PAXLOVID, we expect sales of approximately $22 billion, keeping the guidance range unchanged despite the negative incremental impact of changes in FX.

    關於我們與 COVID-19 相關的收入,我們現在預計今年的疫苗收入約為 340 億美元,與我們之前的指導相比增加了 20 億美元。對於 PAXLOVID,我們預計銷售額約為 220 億美元,儘管外匯變化帶來了負面的增量影響,但指導範圍保持不變。

  • You can see on this slide our updated costs and expense guidance which incorporates our performance to date, our recent acquisitions and our updated expectations for the remainder of the year. More information on each of these updates can be found in this morning's press release.

    您可以在這張幻燈片上看到我們更新的成本和費用指南,其中包含我們迄今為止的表現、我們最近的收購以及我們對今年剩餘時間的更新預期。更多關於這些更新的信息可以在今天早上的新聞稿中找到。

  • 2022 guidance once again assumes no incremental share repurchases beyond the $2 billion of share repurchases we completed in March of 2022.

    2022 年指引再次假設,除了我們在 2022 年 3 月完成的 20 億美元股票回購之外,沒有增量股票回購。

  • In closing, it's an exciting time in the history of Pfizer. We believe that our strong financial performance in the quarter and our improving operational outlook for the year sets the stage for long-term shareholder value creation.

    最後,這是輝瑞歷史上激動人心的時刻。我們相信,我們本季度強勁的財務表現和我們今年不斷改善的運營前景為長期股東價值創造奠定了基礎。

  • With that, I'll now turn it over to Mikael.

    有了這個,我現在把它交給 Mikael。

  • Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

    Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

  • Thank you, Dave. Today, I will focus attention on high-value programs that will potentially deliver breakthroughs in areas of high unmet need and are expected to be key contributors to our growth aspirations through 2025 and beyond.

    謝謝你,戴夫。今天,我將重點關注高價值項目,這些項目可能會在高度未滿足的需求領域取得突破,並有望成為我們到 2025 年及以後實現增長願景的關鍵貢獻者。

  • With anchor products such as COMIRNATY, PAXLOVID, IBRANCE and XTANDI, we are building out comprehensive franchises in several areas, including respiratory, metabolic disorders, genetic hematology and certain cancers. We have deep expertise in these areas, and there is exciting science emerging. I will share updates from 3 of these today: respiratory, metabolic and prostate cancer.

    憑藉 COMIRNATY、PAXLOVID、IBRANCE 和 XTANDI 等主打產品,我們正在多個領域建立全面的特許經營權,包括呼吸、代謝疾病、遺傳血液學和某些癌症。我們在這些領域擁有深厚的專業知識,並且正在出現令人興奮的科學。今天我將分享其中 3 種的最新情況:呼吸癌、代謝癌和前列腺癌。

  • Building on our success with COMIRNATY and PAXLOVID, we see enormous potential to help address major causes of respiratory disease through vaccines and therapeutics. Work on the next-generation vaccine candidates are well underway. And last week, we started a Phase I clinical trial of our second-generation oral therapeutic candidate.

    在我們與 COMIRNATY 和 PAXLOVID 取得成功的基礎上,我們看到了通過疫苗和療法幫助解決呼吸道疾病主要原因的巨大潛力。下一代候選疫苗的工作正在順利進行。上週,我們開始了第二代口服治療候選藥物的 I 期臨床試驗。

  • Our quadrivalent modRNA flu program has progressed into Phase III, and we will start shortly a Phase I study of an mRNA-based vaccine candidate that combines our quadrivalent modRNA flu vaccine candidate with the Omicron-adapted bivalent COVID-19 vaccine based on BA.4/5.

    我們的四價 modRNA 流感計劃已進入 III 期,我們將很快開始一項基於 mRNA 的候選疫苗的 I 期研究,該候選疫苗將我們的四價 modRNA 流感疫苗候選與基於 BA.4 的 Omicron 適應二價 COVID-19 疫苗相結合/5。

  • In RSV, we believe a dual focus on developing a vaccine and antivirals could make a significant impact globally. I will share new data with you shortly.

    在 RSV 中,我們認為雙重關注開發疫苗和抗病毒藥物可能會在全球範圍內產生重大影響。我將很快與您分享新數據。

  • PAXLOVID continues to be an important tool in helping to combat the impact of COVID-19. And secondary endpoints from the EPIC-High Risk study as well as data from real-world evidence support the product's efficacy profile.

    PAXLOVID 仍然是幫助對抗 COVID-19 影響的重要工具。來自 EPIC-High Risk 研究的次要終點以及來自真實世界證據的數據支持該產品的功效概況。

  • In the EPIC-HR study, PAXLOVID reduced COVID-19-related all-cause deaths and ICU admissions by 100% and COVID-19-related hospitalization by 86% in unvaccinated, high-risk patients compared to placebo. It also reduced the duration of COVID-19 symptoms by 2 to 3 days compared to placebo. We are pleased to see PAXLOVID leading the COVID-19 treatment landscape and remain confident in its safety and efficacy in treating patients at high-risk for severe outcomes.

    在 EPIC-HR 研究中,與安慰劑相比,在未接種疫苗的高風險患者中,PAXLOVID 將 COVID-19 相關的全因死亡和 ICU 入院率降低了 100%,將 COVID-19 相關的住院率降低了 86%。與安慰劑相比,它還將 COVID-19 症狀的持續時間縮短了 2 至 3 天。我們很高興看到 PAXLOVID 引領 COVID-19治療領域,並對其治療嚴重後果高風險患者的安全性和有效性充滿信心。

  • We recently reported a positive interim analysis from a Phase III study in older adults of our novel RSV vaccine candidate, which targets the prefusion F protein on both RSV A and B, without need for an adjuvant. We saw remarkable vaccine efficacy across the first RSV season. The vaccine was extremely well tolerated with favorable systemic tolerability, a key consideration for vaccines.

    我們最近報告了一項針對老年人的 III 期研究中對我們的新型 RSV 候選疫苗的積極中期分析,該候選疫苗針對 RSV A 和 B 上的融合前 F 蛋白,無需佐劑。我們在第一個 RSV 季節看到了顯著的疫苗效力。該疫苗的耐受性非常好,具有良好的全身耐受性,這是疫苗的一個關鍵考慮因素。

  • We also are developing the RSVpreF vaccine candidate for use in pregnant women so that protection may be conferred to newborns. And this morning, we announced exciting results from a preplanned interim analysis of our Phase III trial. We observed vaccine efficacy of nearly 82% against severe medically attended lower respiratory tract illness or MA-LRTI due to RSV in infants from birth through the first 90 days of life and efficacy of more than 69% through the first 6 months of life. Success criterion was not met for the second primary endpoint. However, clinically meaningful efficacy was observed with MA-LRTI of 57% in infant from birth through 90 days of life and efficacy of 51% over the 6-month follow-up period. The Data Monitoring Committee indicated the vaccine was well tolerated with no safety concerns for either vaccinated women or their newborns.

    我們還在開髮用於孕婦的 RSVpreF 候選疫苗,以便為新生兒提供保護。今天早上,我們宣布了對我們的 III 期試驗進行預先計劃的中期分析的令人興奮的結果。我們觀察到,嬰兒從出生到生命的前 90 天,疫苗對因 RSV 引起的嚴重下呼吸道疾病或 MA-LRTI 的疫苗效力接近 82%,在生命的前 6 個月效力超過 69%。第二個主要終點未達到成功標準。然而,從出生到 90 天的嬰兒中 MA-LRTI 的療效為 57%,在 6 個月的隨訪期內療效為 51%。數據監測委員會表示,該疫苗耐受性良好,對接種疫苗的婦女或其新生兒沒有安全問題。

  • Given these impressive results, we look forward to filing BLA for both older adults and pregnant women with the U.S. FDA by year-end with potential launches in '23. If approved, our maternal RSV vaccine candidate potentially would be the first available to help prevent this common and potentially life-threatening respiratory illness in young infants.

    鑑於這些令人印象深刻的結果,我們期待在年底前向美國 FDA 提交老年人和孕婦的 BLA,並可能在 23 年推出。如果獲得批准,我們的母體 RSV 候選疫苗可能是第一個有助於預防這種常見且可能危及生命的幼兒呼吸道疾病的候選疫苗。

  • Turning now to prostate cancer. We're building upon the standard of care set by XTANDI in castration-sensitive and castration-resistant population. The Phase III EMBARK study of XTANDI in non-metastatic castration-sensitive prostate cancer is expected to read out first half of '23. And the Phase III TALAPRO-3 study of TALZENNA and XTANDI is expected in '24. These trials may indicate benefit in up to 20% more patients than are currently treated and potentially prolong duration of use, subject to clinical success and regulatory approval.

    現在轉向前列腺癌。我們正在建立在 XTANDI 為去勢敏感和去勢抵抗人群設定的護理標準之上。 XTANDI 在非轉移性去勢敏感性前列腺癌中的 III 期 EMBARK 研究預計將在 23 年上半年公佈。 TALZENNA 和 XTANDI 的 III 期 TALAPRO-3 研究預計在 24 年進行。這些試驗可能表明比目前接受治療的患者多 20% 的患者受益,並可能延長使用時間,但需獲得臨床成功和監管部門的批准。

  • Now in TALAPRO-2, we observed the first clinical benefit of a PARP inhibitor plus XTANDI in men with metastatic castration-resistant prostate cancer with or without homologous recombination repair or HRR gene mutation. Irrespective of HRR gene mutation status, the study achieved its primary endpoint. The combination delivered a significant and clinically meaningful improvement in radiographic progression-free survival and appears to have resulted in the longest observed such survival in a randomized trial in this setting. We are encouraged by these results and believe that TALZENNA in prostate cancer may have blockbuster potential, subject to regulatory approval.

    現在在 TALAPRO-2 中,我們觀察到 PARP 抑製劑聯合 XTADI 在患有或不患有同源重組修復或 HRR 基因突變的轉移性去勢抵抗性前列腺癌的男性中的第一個臨床益處。無論 HRR 基因突變狀態如何,該研究都達到了其主要終點。該組合在放射學無進展生存期方面提供了顯著且具有臨床意義的改善,並且似乎已導致在這種情況下的隨機試驗中觀察到的最長生存期。我們對這些結果感到鼓舞,並相信 TALZENNA 在前列腺癌中可能具有巨大的潛力,但需獲得監管部門的批准。

  • Turning to metabolic disorders. I previously shared that we are developing 2 oral GLP-1 receptor agonist, danuglipron and 1532. Recently presented Phase Ib data for 1532 show dose-dependent reduction from baseline at 4 to 6 weeks in mean daily glucose, fasting plasma glucose, HbA1c and body weight. Both candidates are potentially best-in-class and differentiated by offering full agonism, which may be required to achieve the same level of response as injectable GLP-1 receptor agonists while offering a convenient once daily dose for 1532. Glucose effects plateau at lower doses, while body weight effects continue to improve at higher doses.

    轉向代謝紊亂。我之前分享過我們正在開發 2 種口服 GLP-1 受體激動劑,danuglipron 和 1532。最近提交的 1532 的 Ib 期數據顯示,在 4 至 6 週時,平均每日葡萄糖、空腹血糖、HbA1c 和身體從基線的劑量依賴性降低重量。兩種候選藥物都可能是同類產品中最好的,並且通過提供完全激動作用來區分,這可能需要達到與可注射 GLP-1 受體激動劑相同的反應水平,同時為 1532 提供方便的每日一次劑量。較低劑量的葡萄糖效應平穩,而體重效應在更高劑量下繼續改善。

  • The planned Phase IIb study will evaluate 1532 versus both oral semaglutide and placebo in type 2 diabetes and separately versus placebo in obesity. Using semaglutide as a comparator in the type 2 diabetes arm should allow us to observe potential early signs of differentiation in efficacy, tolerability and safety. We will evaluate doses up to 260 milligrams in this study, higher than the studies in the Phase Ib. We plan to begin dosing soon and anticipate the readout in first quarter 2024.

    計劃中的 IIb 期研究將評估 1532 與口服 semaglutide 和安慰劑治療 2 型糖尿病,以及分別與安慰劑治療肥胖症。使用 semaglutide 作為 2 型糖尿病組的比較劑,我們應該能夠觀察到療效、耐受性和安全性方面潛在的早期分化跡象。我們將在本研究中評估高達 260 毫克的劑量,高於 Ib 期的研究。我們計劃很快開始給藥,並預計 2024 年第一季度的讀數。

  • The ongoing Phase IIb study of danuglipron in obesity with now once-monthly titration is expected to complete second half of 2023. Data from these studies will be available in relatively quick succession and, assuming clinical success, allow us to select one based on efficacy, tolerability and dosing to advance to Phase III in both type 2 diabetes and obesity.

    正在進行的 danuglipron 在肥胖症中進行的 IIb 期研究,現在每月滴定一次,預計將於 2023 年下半年完成。這些研究的數據將相對快速地連續提供,假設臨床成功,我們可以根據療效選擇一項,在 2 型糖尿病和肥胖症中,耐受性和劑量進入 III 期。

  • In closing, we are excited about the developing science within these franchisees and share here recent and anticipated milestones in the next 18 months. We look forward to continue our development both for potential patient benefit and sustainable growth.

    最後,我們對這些特許經營商的科學發展感到興奮,並在此分享未來 18 個月的近期和預期里程碑。我們期待繼續我們的發展,以實現潛在的患者利益和可持續增長。

  • Thank you. Let me turn over to Chris to start Q&A.

    謝謝你。讓我讓克里斯開始問答。

  • Christopher J. Stevo - Senior VP & Chief IR Officer

    Christopher J. Stevo - Senior VP & Chief IR Officer

  • Thanks, Mikael. With that, let's start the Q&A session. We have about 30 minutes for this session. We will answer as many questions as time permits. And Investor Relations will be available after the call to answer any follow-up questions. Chelsea, please go ahead and queue up the first question.

    謝謝,米凱爾。有了這個,讓我們開始問答環節。本次會議我們有大約 30 分鐘的時間。我們將在時間允許的情況下回答盡可能多的問題。投資者關係部將在電話會議後回答任何後續問題。切爾西,請繼續排第一個問題。

  • Operator

    Operator

  • (Operator Instructions) Our first question will come from Umer Raffat with Evercore ISI. We'll go to our next question, Colin Bristow with UBS.

    (操作員說明)我們的第一個問題將來自 Evercore ISI 的 Umer Raffat。我們將轉到下一個問題,瑞銀的科林布里斯托。

  • Colin Nigel Bristow - Analyst

    Colin Nigel Bristow - Analyst

  • On COVID '23 expectations, should we expect anything from you here on the December 12 Investor event? And then just more broadly around this, how are you thinking conceptually about guiding to this? Will it be similar to last year? Are you thinking of more sort of scenario-based guiding? Anything that would be helpful.

    關於 COVID '23 的期望,我們是否應該在 12 月 12 日的投資者活動中對您有所期待?然後更廣泛地圍繞這一點,您如何從概念上考慮指導這一點?會和去年一樣嗎?您是否正在考慮更多基於場景的指導?任何有幫助的東西。

  • And then just a sort of temperature check on business development, if you could update us on your priorities and interests. And then from a deal perspective, just how big would you be willing to go?

    然後只是對業務發展的一種溫度檢查,如果您可以向我們更新您的優先事項和興趣。然後從交易的角度來看,你願意做多大的事情?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you. On the December 12, what you should expect, it is a good overview of our very important new product launches in the coming 18 months, with more details about the science and the market potential of those launches as well as some of the most important pipeline potential new medicines and vaccines, that they are not going to be launched in the next 18 months but will be launched in the period between '24 and '30.

    謝謝你。在 12 月 12 日,您應該期待,它很好地概述了我們在未來 18 個月內非常重要的新產品發布,其中包含有關這些發布的科學和市場潛力以及一些最重要的管道的更多詳細信息潛在的新藥和疫苗,它們不會在未來 18 個月內推出,但將在 24 至 30 年間推出。

  • Now for the BD priorities, I would ask Aamir to reiterate once more our strategy when it comes to BD.

    現在對於 BD 的優先事項,我會要求 Aamir 再次重申我們在 BD 方面的戰略。

  • Aamir Malik - Executive VP & Chief Business Innovation Officer

    Aamir Malik - Executive VP & Chief Business Innovation Officer

  • Thanks for the question, Colin. The BD priorities remain consistent with what we've articulated before. And principally, we are most excited about scientific substrate that has the potential for patient breakthroughs. That's going to continue to be our north star. We're looking for deals that accelerate our top line growth in the back half of the decade. And importantly, we're focused on opportunities where we can add substantial value, and that can come in the form of either shaping the science or also accelerating our commercial momentum. And if you look at the deals that we announced and closed in 2022, including Arena, Biohaven, ReViral and GBT, they would all be very consistent with those priorities.

    謝謝你的問題,科林。 BD 的優先事項與我們之前闡述的內容保持一致。原則上,我們對有可能為患者帶來突破的科學基質感到最興奮。這將繼續成為我們的北極星。我們正在尋找能夠在本世紀後半期加速我們收入增長的交易。重要的是,我們專注於可以增加實質性價值的機會,這可以以塑造科學或加速我們的商業勢頭的形式出現。如果你看看我們在 2022 年宣布並完成的交易,包括 Arena、Biohaven、ReViral 和 GBT,它們都會非常符合這些優先事項。

  • We've said that we are agnostic to size of transaction. But you've also heard us be very clear about the fact that cost synergy-driven deals is not where our focus is going to be. We're going to be focused on driving growth through our BD.

    我們已經說過我們不知道交易的規模。但是您也聽說我們非常清楚,成本協同驅動的交易不是我們的重點。我們將專注於通過我們的 BD 推動增長。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Aamir. And also, Dave, maybe you can also address the question about guidance on COVID and are we going to provide it and when for '23, et cetera.

    謝謝你,阿米爾。另外,戴夫,也許您還可以解決有關 COVID 指導的問題,我們是否會提供指導以及 23 年何時提供指導等。

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Yes. Thank you, Albert. Maybe let me discuss the stage as it relates to COVID and the COVID franchise. I think if you look out longer term, the franchise is going to be a multibillion-dollar franchise in the respect that this is going to be somewhat like a flu, sustained flu, but actually more deadly than the flu. So therefore, I think the products, both from a vaccine and the therapy perspective that Pfizer has developed, are going to be quite relevant for many years to come.

    是的。謝謝你,阿爾伯特。也許讓我討論一下與 COVID 和 COVID 特許經營相關的階段。我認為如果你從長遠來看,特許經營權將是一個數十億美元的特許經營權,這有點像流感,持續性流感,但實際上比流感更致命。因此,我認為輝瑞開發的疫苗和治療方面的產品在未來很多年都將非常重要。

  • Having said that, when we provide guidance for 2023, when it's appropriate to do so, we will give investors a perspective on what our expectations are for the year. We will break out that guidance specifically so you can hold us accountable for delivering on those revenue promises when the time comes.

    話雖如此,當我們為 2023 年提供指導時,在適當的時候,我們將讓投資者了解我們對這一年的預期。我們將特別列出該指南,以便您可以讓我們負責在時機成熟時兌現這些收入承諾。

  • Operator

    Operator

  • Next, we have Louise Chen with Cantor.

    接下來,我們請到 Cantor 的 Louise Chen。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So I wanted to ask you, first off, how you think about -- or maybe more color on how you think about the pushes and pulls in 2023. There's a lot of moving parts there.

    所以我想問你,首先,你是怎麼想的——或者也許更多的是關於你如何看待 2023 年的推動和拉動。那裡有很多活動的部分。

  • And then secondly, on your RSV franchise, there seems to be several players with drugs in development and they've all reported out positive data. So curious how you think about this market playing out over time?

    其次,在您的 RSV 特許經營權中,似乎有幾位正在開發藥物的玩家,他們都報告了積極的數據。很好奇你如何看待這個市場隨著時間的推移而發展?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. Let me say a few words about the push and pulls, and then I will ask Angela to complement and then speak about how we see the RSV market.

    是的。讓我說幾句推拉,然後我會請安吉拉補充,然後談談我們如何看待 RSV 市場。

  • Clearly, '23 is a very, very important year for us given the unprecedented number of new launches that we are going to have in the next 18 months. And most of them will happen in '23 and some beginning of the first quarter of '24. But we are launching products, not only a very big number of them, but only the internal ones, $20 billion, excluding the BD, Biohaven and the Global Blood, $20 billion of peak sales were expected 2030 sales we are expecting from those launches. So it's a very, very big number. And it's very important for us to do it well. In addition, so clearly, that will bring -- our non-COVID business will be a significant boost for our non-COVID business.

    顯然,鑑於我們將在未來 18 個月內推出空前數量的新產品,23 年對我們來說是非常非常重要的一年。其中大部分將發生在 23 年和 24 年第一季度的一些開始。但我們正在推出產品,不僅數量非常多,而且只是內部產品,200 億美元,不包括 BD、Biohaven 和 Global Blood,預計 2030 年這些產品的銷售峰值將達到 200 億美元。所以這是一個非常非常大的數字。做好這件事對我們來說非常重要。此外,很明顯,這將帶來 - 我們的非 COVID 業務將大大推動我們的非 COVID 業務。

  • Now when we move to COVID, we expect '23 will be a transition year with likely in the U.S. moving from a government model into a commercial model for vaccines and therapeutics. The timing is not certain. So we are ready to do it ASAP, but we will be phased over the years. And it likely will not be the same for PAXLOVID or COMIRNATY. And clearly also, there will be some stuff that will have to be depleted in '23. And clearly, will be new price dynamics as we are moving to '23. So COVID will be a little bit more of a transitional year in '23 until it will be established into more like a flu volumes type of market. But of course, with different price points and different severity of the disease, that will bring both therapeutic and vaccines into a multibillion-dollars franchise. But we are not going to predict now what will be the number for the years out, but we will try to be as accurate as possible for our '23 numbers when we will provide guidance.

    現在,當我們轉向 COVID 時,我們預計 23 年將是一個過渡年,美國可能會從政府模式轉變為疫苗和療法的商業模式。時間不確定。所以我們準備盡快做,但我們將分階段進行。 PAXLOVID 或 COMIRNATY 可能不會相同。很明顯,在 23 年將有一些東西必須耗盡。很明顯,隨著我們進入 23 世紀,這將是新的價格動態。因此,在 23 年,COVID 將更像是一個過渡年,直到它將被建立成更像流感量類型的市場。但是,當然,不同的價格點和不同的疾病嚴重程度,這將使治療藥物和疫苗成為數十億美元的特許經營權。但我們現在不打算預測未來幾年的數字,但當我們提供指導時,我們會盡量準確地預測我們的 '23 數字。

  • Now Angela, anything to add on the push and pulls? You are carrying a lot of the weight for the new launches and also speak about one of them, which is going to be the RSV maternal and adult.

    現在安吉拉,有什麼要添加的推拉?您為新的發布承擔了很大的責任,並且還談到了其中一個,這將是 RSV 母體和成人。

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Well, we're extremely excited about both the adult vaccine as well as the maternal vaccine. First and foremost, because it is in the sweet spot of what Pfizer does, respiratory vaccines, right? We have a lot of experience of this created through the legacy of our pneumococcal franchise and the strength we have there but also recently from COMIRNATY.

    好吧,我們對成人疫苗和母體疫苗都感到非常興奮。首先也是最重要的,因為它是輝瑞公司所做的呼吸系統疫苗的最佳選擇,對吧?通過我們肺炎球菌專營權的遺產和我們在那裡擁有的實力以及最近來自 COMIRNATY 的實力,我們在這方面擁有豐富的經驗。

  • I'll also add that Pfizer is the only company that has both the adult vaccine as well as the maternal vaccine. And it really does fit so extremely well into our existing commercial footprint. These are large populations, both the adult as well as maternal.

    我還要補充一點,輝瑞是唯一一家同時擁有成人疫苗和母體疫苗的公司。它確實非常適合我們現有的商業足跡。這些人口眾多,包括成人和母親。

  • Let me just start with adult and just sort of characterize that a bit. There's 61 million 65-year-olds, all of whom are eligible for this vaccination. It's actually a -- it's quite a devastating disease. The hospital costs from RSV for adults is over $1.2 billion. It is also underreported and underdiagnosed. And so we have a really great opportunity here to drive awareness of this disease but also to use the commercial footprint that we already have to create awareness, to create education and to bring this vaccine to those who need it.

    讓我從成人開始,然後稍微描述一下。有 6100 萬 65 歲的人都有資格接種這種疫苗。它實際上是一種——它是一種毀滅性的疾病。成人 RSV 的醫院費用超過 12 億美元。它也被低估和診斷不足。因此,我們在這裡有一個非常好的機會來提高對這種疾病的認識,同時也可以利用我們已經擁有的商業足跡來提高認識,開展教育並將這種疫苗帶給需要的人。

  • Equally, in the maternal space, a devastating disease. Most of the mortality and the morbidity is in infants that are under 6 months old and those that are preterm. And actually, over 102,000 deaths worldwide are resulting from infant infections of RSV. So again, we see a tremendous opportunity to make a difference here.

    同樣,在母體領域,這是一種毀滅性的疾病。大多數死亡率和發病率發生在 6 個月以下的嬰兒和早產兒中。實際上,全世界有超過 102,000 人死於 RSV 嬰兒感染。因此,我們再次看到了在這裡有所作為的巨大機會。

  • As you know, through the work that we've done on Prevnar, we have a tremendous legacy in pediatric vaccines. And so that, coupled with our strength in women's health and the commercial footprint we have there as well, is going to be perfectly suited for us to launch the maternal RSV vaccine.

    如您所知,通過我們在 Prevnar 上所做的工作,我們在兒科疫苗方面擁有巨大的遺產。因此,再加上我們在女性健康方面的實力以及我們在那裡擁有的商業足跡,將非常適合我們推出孕產婦 RSV 疫苗。

  • And so bringing all of this together, I think that we have the scientific knowledge, we have the technology, we have the relationships with the vaccinators and the sites of vaccinations. We are also very well versed in our work with the vaccine technical committees around the world, in bringing together a broad recommendation, which we believe is what's going to give us access to many, many infants as well as adults to these 2 tremendous breakthroughs. So I think we have the best-in-class capabilities to do a great job with this respiratory portfolio.

    因此,將所有這些結合在一起,我認為我們擁有科學知識,我們擁有技術,我們與疫苗接種者和疫苗接種地點有關係。我們還非常精通與世界各地的疫苗技術委員會的合作,匯集了廣泛的建議,我們相信這將使我們能夠接觸到許多嬰兒和成人,從而獲得這兩個巨大的突破。因此,我認為我們擁有一流的能力,可以在這個呼吸產品組合方面做得很好。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Very well, Angela, and I agree with you.

    很好,安吉拉,我同意你的看法。

  • Operator

    Operator

  • Next, we have Steve Scala with Cowen.

    接下來是 Steve Scala 和 Cowen。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I have three questions, but they're all short. First, what impact on RSV-associated infant hospitalizations did Pfizer see in the Phase III MATISSE trial?

    我有三個問題,但都很簡短。首先,輝瑞在 III 期 MATISSE 試驗中看到了對 RSV 相關嬰兒住院的影響是什麼?

  • Second, can you tell us what NURTEC sales were in Q3? I know you didn't own Biohaven in Q3, but you likely know the number.

    其次,您能告訴我們第三季度 NURTEC 的銷售額是多少嗎?我知道你在第三季度沒有擁有 Biohaven,但你可能知道這個數字。

  • And then lastly, all things considered, is it unrealistic to think that COMIRNATY plus PAXLOVID sales could be as much as $15 billion in 2030?

    最後,考慮到所有因素,認為 COMIRNATY 加上 PAXLOVID 的銷售額在 2030 年可能高達 150 億美元是不現實的嗎?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. Mikael, what about the RSV data?

    非常感謝。 Mikael,RSV 數據呢?

  • Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

    Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

  • Thank you for the question. So as you have seen in our press release, we reported out very impressive data and the 2 separate primary endpoints that were independent, it is sufficient to hit one for filing. And to our privilege and encouragement, we hit strongly on the most important. And that was defined as severe, medically attended lower tract respiratory infections, where we had close to 82% vaccine efficacy. That is defined by clinical features, such as the rate and the stress of respiration, oxygenation levels, et cetera, in the children and will include patients, whether they are hospitalized or not.

    感謝你的提問。因此,正如您在我們的新聞稿中看到的那樣,我們報告了非常令人印象深刻的數據和兩個獨立的獨立主要終點,只需點擊一個即可歸檔。為了我們的特權和鼓勵,我們強烈地打擊了最重要的事情。這被定義為嚴重的、就醫的下呼吸道感染,我們有接近 82% 的疫苗效力。這是由臨床特徵定義的,例如兒童的呼吸速率和壓力、氧合水平等,並將包括患者,無論他們是否住院。

  • We will later release data on secondary endpoints that include hospitalization. When you look at this dramatic effect on the severe infections, it seems very reasonable to project that we will have a dramatic impact in lowering hospitalizations. I'm probably talking about tens of thousands of hospitalizations in the U.S. that may not happen if this vaccine is used to vaccinate maternal prior to delivering children as appropriately studied in this vaccination. So we're very encouraged and optimistic about that type of value.

    我們稍後將發布包括住院在內的次要終點數據。當你看到這種對嚴重感染的巨大影響時,我們可以預測我們將對降低住院率產生巨大影響,這似乎是非常合理的。我可能是在談論美國數以萬計的住院治療,如果這種疫苗用於在分娩前為產婦接種疫苗,那麼這種情況可能不會發生。所以我們對這種價值感到非常鼓舞和樂觀。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Mikael. Before I turn to Dave to answer the question about the sales of NURTEC in the third quarter, let me make a comment on COMIRNATY and PAXLOVID and the franchise.

    謝謝你,米凱爾。在我轉向戴夫回答有關 NURTEC 第三季度銷售額的問題之前,讓我對 COMIRNATY 和 PAXLOVID 以及特許經營權進行評論。

  • Clearly, we said that we will provide us good picture of what we expect to be the sales for next year. Now you're asking about year 2030, which is even more challenging. But also, the way you are asking the question, is it unthinkable -- is it unreasonable to think that we could have a $15 billion franchise? Well, taking that it is $55 billion right now, it's not unreasonable to think that in year 2030, could be that. But it's not clear that it will be done. So that will depend on the virus and how it behaves. It will depend on if it will become standard practice to vaccinate together with flu. If we will have a combination product, clearly, that will enhance this direction. So I think it's a little bit too early, but no, it's not unreasonable to think given that where we are right now.

    顯然,我們說過我們將為我們提供明年預期銷售額的良好畫面。現在你問的是 2030 年,這更具挑戰性。而且,你問這個問題的方式,是不可想像的 - 認為我們可以擁有 150 億美元的特許經營權是不合理的嗎?好吧,考慮到它現在是 550 億美元,認為 2030 年可能是這樣並不是不合理的。但目前尚不清楚它是否會完成。因此,這將取決於病毒及其行為方式。這將取決於與流感一起接種疫苗是否會成為標準做法。如果我們將有一個組合產品,顯然,這將加強這個方向。所以我認為這有點太早了,但不,考慮到我們現在所處的位置,這並不是不合理的。

  • Now, what about NURTEC sales?

    現在,NURTEC 的銷售情況如何?

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Yes. Steve, this is Dave. As you said, we didn't own the business last quarter, but maybe just a little bit of color on how the product is performing.

    是的。史蒂夫,這是戴夫。正如您所說,我們上個季度沒有擁有該業務,但可能只是對產品的表現有一點影響。

  • If you look at the volume last year, or last quarter, rather, Q3, if you compare it to last year, it was about a 45% growth rate in year-over-year script volume. And then if you look at it sequentially, which I think is really important, we saw about a 16% growth rate sequentially Q2 going into Q3. So I think this shows the promise of this product, number one.

    如果您查看去年的數量,或者上個季度,而不是第三季度,如果您將其與去年進行比較,那麼腳本數量的同比增長率約為 45%。然後,如果您按順序看,我認為這非常重要,我們看到第二季度到第三季度的增長率約為 16%。所以我認為這表明了這個產品的承諾,第一。

  • And number two, I think once we get it, now that we have it in the hands of our field force and into our primary care field force, we can really maximize the value of this needed medicine into the patient population here in the U.S. and abroad.

    第二,我認為一旦我們得到它,現在我們將它掌握在我們的現場部隊和我們的初級保健現場部隊中,我們真的可以最大限度地提高這種所需藥物對美國患者群體的價值,並且國外。

  • Operator

    Operator

  • Our next question will come from Robyn Karnauskas with Truist Securities.

    我們的下一個問題將來自 Truist Securities 的 Robyn Karnauskas。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • Great. On PAXLOVID, I was just -- I'm sure you saw the recent publication citing how many people have died from not even getting an antiviral. Can you talk a little bit about the efforts you're making to educate physicians to give the drug? And do you think we'll ever get to a point where people will be more comfortable, doctors will be more comfortable taking it, given all the news around the PAXLOVID rebound?

    偉大的。在 PAXLOVID 上,我只是 -- 我相信你看到最近的出版物引用了有多少人死於甚至沒有得到抗病毒藥物。你能談談你為教育醫生服用藥物所做的努力嗎?考慮到有關 PAXLOVID 反彈的所有消息,您認為我們是否會達到人們會更舒服、醫生會更舒服地服用它的地步?

  • And second question, can you talk a little bit about the opportunity for vitiligo and alopecia in your pipeline? And when should we hear the next readout?

    第二個問題,你能談談你的管道中白癜風和脫髮的機會嗎?我們什麼時候應該聽到下一個讀數?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. Both questions, I think, can be answered very nicely by Angela.

    非常感謝。我認為,安吉拉可以很好地回答這兩個問題。

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Well, thank you for the question. So we can just talk a little bit about PAXLOVID and how that's been going. I mean, first and foremost, we are under an EUA, so that means that we are working hand-in-hand with the U.S. government to ensure that we are providing the education to the public.

    嗯,謝謝你的問題。所以我們可以談談 PAXLOVID 以及它的進展情況。我的意思是,首先,我們處於 EUA 之下,這意味著我們正在與美國政府攜手合作,以確保我們向公眾提供教育。

  • The U.S. government and the state governments, I think, have created a tremendous amount of education already using public service announcements and public campaigns. And equally, we have provided education to all the potential prescribers of PAXLOVID.

    我認為,美國政府和州政府已經利用公共服務公告和公共活動創造了大量的教育。同樣,我們為所有潛在的 PAXLOVID 處方者提供了教育。

  • So if you think about where we are today, over 500,000 physicians have written PAXLOVID. And what you have in addition to that is education that we've provided not only to doctors but also to pharmacists. We've trained over 80,000 pharmacists in terms of how to write PAXLOVID.

    因此,如果您想想我們今天所處的位置,超過 500,000 名醫生撰寫了 PAXLOVID。除此之外,您還擁有我們不僅為醫生提供的教育,還為藥劑師提供教育。我們已經對 80,000 多名藥劑師進行瞭如何編寫 PAXLOVID 的培訓。

  • And so I think the education is really firing off, both at a prescriber level but also at a consumer level where we have worked, again, also closely with state governments and local governments, to ensure that we're providing the right amount of education.

    所以我認為教育真的很火爆,無論是在處方者層面,還是在消費者層面,我們一直在與州政府和地方政府密切合作,以確保我們提供適量的教育.

  • I will say that the Test to Treat sites that the government has stood up federally, there's now 27,000 of those around the country, have also been great sources of education for PAXLOVID.

    我要說的是,政府在聯邦政府設立的“治療測試”網站,現在全國有 27,000 個網站,也是 PAXLOVID 教育的重要來源。

  • So I think that it's -- frankly, I think it's going well. I think that we're continuing to do more in anticipation of the fall. But the fact that you've had 500,000 physicians write this PAXLOVID already is a great indicator of their confidence with this.

    所以我認為它 - 坦率地說,我認為它進展順利。我認為我們會繼續做更多的工作來迎接秋天。但是,您已經有 500,000 名醫生編寫了此 PAXLOVID,這一事實很好地表明了他們對此的信心。

  • And the fact that probably, the one most important area of education that we need to continue to emphasize is just who are the eligible people for PAXLOVID. And actually, if you look at the definition that the CDC provides, there are 22 risk factors for who should be eligible. And they include those who are over 65, right, age-related risks, but equally, risks such as mental health illness, risks such as an inactive lifestyle, risks that you may not be aware of. And so I think that that's really where we want to focus now through this fall.

    事實上,我們需要繼續強調的一個最重要的教育領域可能就是誰是 PAXLOVID 的合格人員。實際上,如果您查看 CDC 提供的定義,則有 22 個風險因素決定誰應該符合條件。它們包括 65 歲以上的人,對,與年齡相關的風險,但同樣包括心理健康疾病等風險、不活躍的生活方式等風險,以及您可能不知道的風險。所以我認為這才是我們今年秋天真正想要關注的地方。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • And what about vitiligo?

    那麼白癜風呢?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • I think we're really excited about these new indications for ritlecitinib. I think probably the main theme here is that there are not effective -- there aren't any treatments for these highly -- very serious inflammatory conditions today. So huge unmet need, huge -- just a place where there's just no options today. So the fact that we're able to bring a treatment like this to market, I think, will have tremendous uptake by patients who up to now just are left with no options.

    我認為我們對 ritlecitinib 的這些新適應症感到非常興奮。我認為這裡的主要主題可能是沒有有效的 - 今天沒有任何治療這些高度 - 非常嚴重的炎症狀況。如此巨大的未滿足需求,巨大的——只是一個今天沒有選擇的地方。因此,我認為,我們能夠將這樣的治療推向市場這一事實將被迄今為止別無選擇的患者大量接受。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • And William, can you please address a little bit the issue about the rebounds that was also mentioned?

    還有威廉,你能稍微解決一下剛才提到的籃板問題嗎?

  • William Pao - Executive VP & Chief Development Officer

    William Pao - Executive VP & Chief Development Officer

  • Sure, Albert. Well, Mikael already mentioned that we gave updated data from our EPIC-HR study on the effect of PAXLOVID versus placebo in patients with high risk for COVID-19. And we had additional end points there which we showed a 100% decrease in ICU admissions, a 100% decrease in mechanical ventilation among hospitalized patients, 100% who got PAXLOVID were DC-ed to home versus 53% placebo. We also had 82% reduction in oxygen support, 86% reduction in COVID-19-related hospitalization, 89% reduction in mean days hospitalized versus 100 patients and also a 73% reduction in any COVID-19-related medical visits.

    當然,阿爾伯特。好吧,Mikael 已經提到我們提供了 EPIC-HR 研究的最新數據,這些數據是關於 PAXLOVID 與安慰劑對 COVID-19 高風險患者的影響。我們在那裡有額外的終點,我們顯示 ICU 入院人數減少了 100%,住院患者的機械通氣減少了 100%,接受 PAXLOVID 的 100% 接受了 DC-ed 到家,而安慰劑為 53%。氧氣支持減少了 82%,與 COVID-19 相關的住院減少了 86%,與 100 名患者相比,平均住院天數減少了 89%,任何與 COVID-19 相關的就診次數也減少了 73%。

  • Importantly, we also showed sustained time to symptom alleviation and sustained time to symptom resolution of an impact of 2 to 3 days of PAXLOVID versus placebo.

    重要的是,我們還顯示了 PAXLOVID 與安慰劑相比 2 至 3 天的影響,症狀緩解的持續時間和症狀消退的持續時間。

  • But most importantly, about rebounds, there's been several studies recently that have shown actually that rebound occurs with COVID, in general. For example, there was a recent publication of 158 patients who got placebo with COVID and actually, 1/3 of those had recurrent symptoms after the resolution of their symptoms, suggesting that it's a phenomenon associated with COVID and not with PAXLOVID.

    但最重要的是,關於反彈,最近有幾項研究表明實際上反彈通常與 COVID 一起發生。例如,最近有 158 名患者接受 COVID 安慰劑治療,實際上,其中 1/3 在症狀消退後出現復發症狀,這表明這是與 COVID 相關的現象,而不是與 PAXLOVID 相關的現象。

  • Importantly, we also haven't seen any evidence of resistance that is clinically meaningful. Whereas with antibodies, for example, we have seen that you can also can get symptom rebound, but that is associated with resistance. So again, PAXLOVID is not associated with resistance but the antibodies are. So we feel very confident that PAXLOVID has a significant impact and a role against COVID.

    重要的是,我們還沒有看到任何具有臨床意義的耐藥性證據。以抗體為例,我們已經看到您也可以使症狀反彈,但這與抵抗力有關。同樣,PAXLOVID 與耐藥性無關,但抗體與耐藥性有關。因此,我們非常有信心 PAXLOVID 對 COVID 產生重大影響和作用。

  • Operator

    Operator

  • Next, we have Andrew Baum with Citi.

    接下來是花旗的 Andrew Baum。

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • A couple of questions. Firstly, as it relates to maternal RSV vaccine. Could you talk about reimbursement coverage in the U.S.? I'm assuming you'll get an ACIP recommendation. And therefore, there will be 0 out of pocket, which may differentiate it versus the monoclonal. And I'm sure on a cost basis, that will be material.

    幾個問題。首先,因為它與母體 RSV 疫苗有關。你能談談美國的報銷範圍嗎?我假設你會得到一個 ACIP 推薦。因此,自掏腰包將是 0,這可能會將其與單克隆區分開來。而且我敢肯定,從成本的角度來看,這將是重要的。

  • And then secondly, could you talk to your efforts with your ER degrader with Arvinas in light of the evolving data on SERDs? Thinking about Astra's recent positive trial on MDS [L1] subgroup. Do you believe that this is a function of defining the right patient population at the right stage of the disease rather than the potential risk to the development of the entire category?

    其次,根據不斷變化的 SERD 數據,您能否談談您與 Arvinas 的 ER 降解器的工作?思考 Astra 最近對 MDS [L1] 亞組的陽性試驗。您是否認為這是在疾病的正確階段定義正確的患者群體的功能,而不是整個類別發展的潛在風險?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Drew, thank you. In the interest of time, let me give the first answer. Yes, you are right. As long as the product is recommended by CDC, and we believe with this type of efficacy, it will be recommended, there is 0 co-pay irrelevant of the insurance. If it is commercial or if it is public, their obligation is 0 co-pay from the payers, and they have to cover it. Mikael, what about the Arvinas molecules?

    德魯,謝謝。由於時間關係,我先給出第一個答案。是的你是對的。只要是CDC推薦的產品,而且我們相信有這種功效,就會被推薦,與保險無關的共付額為0。如果是商業的或公共的,他們的義務是付款人的 0 共付額,他們必須承擔。 Mikael,Arvinas 分子呢?

  • Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

    Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

  • Yes. Thank you for asking. Clearly, we think that there are 2 factors that will separate out the good drugs from the less good in this class of degraders. And we think that PROTAC, which is the mechanistic name of the 471, is more effective in down-regulating the estrogen receptor. And selecting the right patients compared to standard of care, that includes selecting patients that have estrogen receptor mutations and need more powerful drugs and it's related to the property of the drug itself.

    是的。謝謝你的慰問。顯然,我們認為有兩個因素可以將這類降解劑中的好藥與較差的藥物區分開來。我們認為PROTAC,即471的機械名稱,在下調雌激素受體方面更有效。選擇合適的患者與護理標準相比,包括選擇具有雌激素受體突變並需要更強大藥物的患者,這與藥物本身的性質有關。

  • We look forward to advance that drug with Arvinas to pivotal studies in the relatively near future and also to soon reveal to you a lot of progress we had in our breast cancer franchise, including the CDK4 drug. And that may be part of what we consider to share in December at the investor update on launches and next waves.

    我們期待在不久的將來與 Arvinas 一起推進該藥物進行關鍵研究,並很快向您展示我們在乳腺癌特許經營方面取得的許多進展,包括 CDK4 藥物。這可能是我們考慮在 12 月在發布和下一波投資者更新中分享的內容的一部分。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Mikael. Another reason to attend this great event.

    謝謝你,米凱爾。參加這個盛會的另一個原因。

  • Operator

    Operator

  • Next, we have Evan Seigerman with BMO Capital Markets.

    接下來是 BMO 資本市場的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • Congrats on the progress. Two questions for me. On BD, I want to be brief here. But can you talk about what other therapeutic areas you might want to explore? I know you're in neurology with Biohaven, nonmalignant hematology with GBT and, of course, inflammation. Would you consider adding oncology?

    祝賀進展。我有兩個問題。關於BD,我想在這裡簡要介紹一下。但是你能談談你可能想探索的其他治療領域嗎?我知道你在 Biohaven 從事神經病學,在 GBT 從事非惡性血液學,當然還有炎症。你會考慮增加腫瘤學嗎?

  • And on the same line, kind of, Albert, in some previous comments ahead of this call, you had mentioned going alone with some of your mRNA technologies. What applications of mRNA do you see outside of COVID? I mean this personalized cancer vaccine is an area that you would explore.

    在同一條線上,阿爾伯特,在本次電話會議之前的一些評論中,你曾提到單獨使用你的一些 mRNA 技術。您在 COVID 之外看到了 mRNA 的哪些應用?我的意思是這種個性化的癌症疫苗是一個你會探索的領域。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Maybe I'll pass that to Aamir.

    也許我會把它傳給阿米爾。

  • Aamir Malik - Executive VP & Chief Business Innovation Officer

    Aamir Malik - Executive VP & Chief Business Innovation Officer

  • Sure. Evan, thanks for the question. As far as our therapeutic areas of focus, as I mentioned before in our priorities, our focus is on where we can make a difference and shape the science. And the good news is we actually have distinctive capabilities across many different therapeutic areas. So you've seen us active in internal medicine, anti-infectives, I&I and, certainly, oncology. And our focus is going to be on where we have breakthrough science and the potential to shape it. And we feel very good about the breadth of our scientific capabilities to give us lots of flexibility to work in different TAs.

    當然。埃文,謝謝你的問題。就我們的治療重點領域而言,正如我之前在我們的優先事項中提到的那樣,我們的重點是我們可以在哪些方面有所作為並塑造科學。好消息是我們實際上在許多不同的治療領域都有獨特的能力。因此,您已經看到我們活躍於內科、抗感染、I&I,當然還有腫瘤學。我們的重點將放在我們擁有突破性科學和塑造它的潛力上。我們對我們的科學能力的廣度感到非常滿意,這給了我們在不同 TA 工作的很大靈活性。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Aamir. Yes, we didn't answer the mRNA and how we think about it, Mikael.

    謝謝你,阿米爾。是的,我們沒有回答 mRNA 以及我們如何看待它,Mikael。

  • Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

    Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

  • Yes. So I'm excited to share we're broadening that platform. You heard about advance of the mRNA flu vaccine successfully to the next stages. Albert mentioned plans that are ongoing to combine it with COVID vaccine to build more broader respiratory vaccine with indeed improved convenience in single administration, single-patient visits.

    是的。所以我很高興與大家分享我們正在擴大這個平台。您聽說了 mRNA 流感疫苗成功進入下一階段的消息。 Albert 提到了正在進行的計劃,將其與 COVID 疫苗相結合,以構建更廣泛的呼吸道疫苗,在單次給藥、單次患者就診中確實提高了便利性。

  • We are on our way to the Phase I study, together with BioNTech, on our shingles vaccine that really aim to deliver the power of the mRNA, but remove what we've seen as a pretty significant issue with [teratogenicity] of the current adjuvant vaccine.

    我們正與 BioNTech 一起對我們的帶狀皰疹疫苗進行 I 期研究,該疫苗真正旨在提供 mRNA 的力量,但消除了我們認為當前佐劑的 [致畸性] 的一個非常重要的問題疫苗。

  • We're looking at several other mRNA vaccine that we will share in proper time. But also, that Aamir briefly alluded to, we have made progress in our alliance with Beam to really identify the first type of candidates that will move forward to genetic medicine in some of the important rare diseases. And we're looking at application at certain areas of in vivo cancer medications, where we think this technology can be more successful where compared to the past of cancer vaccines.

    我們正在研究其他幾種 mRNA 疫苗,我們將在適當的時候分享這些疫苗。而且,正如 Aamir 簡要提到的,我們在與 Beam 的聯盟中取得了進展,以真正確定第一類將在一些重要的罕見疾病中推進基因醫學的候選者。我們正在研究體內癌症藥物的某些領域的應用,我們認為與過去的癌症疫苗相比,這項技術可以更成功。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much, Mikael.

    非常感謝你,米凱爾。

  • Operator

    Operator

  • Next is Mohit Bansal with Wells Fargo.

    接下來是富國銀行的 Mohit Bansal。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • So on RSV vaccine side, I mean -- so the congress on the data in maternal vaccine, my question is Sanofi has an antibody which you can give to an infant directly and it shows good results. So in your opinion, I mean, the strategy, there could be one strategy, you immunize moms, expecting moms versus infants directly. How do you think about the end market shaking out eventually?

    所以在 RSV 疫苗方面,我的意思是——關於母體疫苗數據的大會,我的問題是賽諾菲有一種抗體,你可以直接給嬰兒服用,它顯示出很好的結果。所以在你看來,我的意思是,策略,可能有一種策略,你免疫媽媽,直接期待媽媽和嬰兒。您如何看待最終市場的震盪?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. Angela, do you want to say how we could compete potentially with an antibody in infants?

    是的。安吉拉,你想說我們如何與嬰兒中的抗體競爭嗎?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Yes. I mean, first of all, if you look at where the -- most of the morbidity and mortality is happening, it's really at the under 6 months, right, in that age group and also with preterm babies. And so you really need that protection from day 1. And I think that that's where we believe our differentiation is. From birth, literally from the moment of birth, you have protection. And you have duration of protection throughout the 6 months, which is what we've shown in our clinical trial.

    是的。我的意思是,首先,如果你看看大多數發病率和死亡率發生在哪裡,實際上是在 6 個月以下,對,在那個年齡組和早產兒中。所以你真的需要從第一天開始的保護。我認為這就是我們認為我們的差異化所在。從出生起,從字面上看,從出生的那一刻起,你就有了保護。而且您在整個 6 個月內都有保護期,這就是我們在臨床試驗中所展示的。

  • So I think while there -- I mean, obviously, it's great to have many different options. I think that the option that we have with our vaccine is truly a unique one and one that plays well to the situation with the infants.

    所以我認為在那裡 - 我的意思是,很明顯,有很多不同的選擇很棒。我認為我們對疫苗的選擇確實是一種獨特的選擇,並且可以很好地適應嬰兒的情況。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. And of course, Andrew made also the point, with vaccines, we do not have co-pays. And antibodies are quite expensive, and you do have co-pays.

    非常感謝。當然,安德魯也指出,對於疫苗,我們沒有共同支付。抗體非常昂貴,而且你確實有共同支付。

  • Operator

    Operator

  • Next, we have Tim Anderson with Wolfe Research.

    接下來,我們有沃爾夫研究的蒂姆安德森。

  • Brian Tsang - Research Analyst

    Brian Tsang - Research Analyst

  • This is Brian on for Tim. Just two from us. What is Pfizer's current level of interest in Alzheimer's disease? And do you think there are compelling business development opportunities in the market? Or would the efforts likely to be homegrown?

    這是蒂姆的布萊恩。我們只有兩個。輝瑞目前對阿爾茨海默病的興趣程度如何?您認為市場上有引人注目的業務發展機會嗎?或者這些努力可能是本土的?

  • And then second, on the Prevnar 20 and the competition. Wondering if you can opine on Merck's strategy, which is to bifurcate the market between peds and adults and have a product tailored to each segment. They have strains in each and they will be going head-to-head against Prevnar. They said a tailored approach is better than a one-size-fits-all approach, which is what Prevnar is. Just wanted to get your thoughts on that.

    其次,關於 Prevnar 20 和比賽。想知道您是否可以對默克公司的策略發表意見,該策略是將 peds 和成人市場分開,並為每個細分市場量身定制產品。他們每個人都有壓力,他們將與 Prevnar 正面交鋒。他們說,量身定制的方法比千篇一律的方法要好,這就是 Prevnar 的特色。只是想了解一下你的想法。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. Clearly, as you know, Pfizer had externalized their neuroscience portfolio, and we have created a company that's working on that actually. And we have a very significant equity over there.

    非常感謝。顯然,如您所知,輝瑞已經將他們的神經科學產品組合外部化了,我們已經創建了一家公司,實際上正在從事這方面的工作。我們在那裡擁有非常可觀的股權。

  • We are monitoring how science is evolving. And apparently, there are a few things that are happening right now. I'm not referring only to the positive data of one study that we just saw, I'm more referring to earlier science that is emerging that seems to have a high promising for most clinical results.

    我們正在監測科學是如何發展的。顯然,現在正在發生一些事情。我不僅僅指我們剛剛看到的一項研究的積極數據,我更多地指的是新興的早期科學,似乎對大多數臨床結果都有很高的希望。

  • So we are monitoring that. And if we think that there is a good opportunity, we may reexamine entering. The reason why we actually want to exit is because we felt the science is not ready at the time.

    因此,我們正在對此進行監控。如果我們認為有一個很好的機會,我們可能會重新審視進入。我們真正想要退出的原因是因為我們覺得當時的科學還沒有準備好。

  • Now I will move it to Angela to answer your second question.

    現在我將它轉移給安吉拉來回答你的第二個問題。

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • We're really proud of our pneumococcal vaccine franchise. And I want to begin with just talking about the great successes that Prevnar 20 has had since its launch. Even though it's competing with other -- with another pneumococcal or other pneumococcal vaccines, we have a 95% market share. We have 97% formulary access. And we just recently had an updated ACIP recommendation that is going to enable Prevnar 20 to be used for catch-ups in those that are 65 plus as well as 65 under. And so I think that, that is a great demonstration of the leadership and the legacy that Pfizer has in pneumococcal vaccines or respiratory vaccines and the tremendous relationships and knowledge that we have in the space.

    我們為我們的肺炎球菌疫苗專營權感到非常自豪。我想首先談談 Prevnar 20 自推出以來所取得的巨大成功。即使它與其他肺炎球菌或其他肺炎球菌疫苗競爭,我們仍擁有 95% 的市場份額。我們擁有 97% 的處方集訪問權限。我們最近剛剛獲得了更新的 ACIP 建議,該建議將使 Prevnar 20 能夠用於 65 歲以上和 65 歲以下的追趕者。所以我認為,這很好地證明了輝瑞在肺炎球菌疫苗或呼吸道疫苗方面的領導地位和遺產,以及我們在該領域擁有的巨大關係和知識。

  • Equally, that plays out in the pediatric space. So even though we're obviously anticipating the launch of pediatric Prevnar 20, but in the meantime, Prevnar 13 is competing really well with the PCV15. I think that, again, the relationships that we have, the deep trust and knowledge that physicians have of the -- of our pneumococcal vaccine is really standing -- is really helping us competitively. And I think that there's great anticipation for the 5 additional serotypes that you're going to be able to get with Prevnar 20 over 15 in the pediatric space.

    同樣,這也在兒科領域發揮作用。因此,儘管我們顯然期待兒科 Prevnar 20 的推出,但與此同時,Prevnar 13 與 PCV15 的競爭非常好。我認為,我們擁有的關係、醫生對我們的肺炎球菌疫苗的深刻信任和知識確實有效,這確實有助於我們提高競爭力。而且我認為,在兒科領域,您將能夠通過 Prevnar 20 over 15 獲得 5 種額外的血清型,這是非常值得期待的。

  • So I think all in all, we're off to an extremely strong start and we look forward to bringing our next vaccine to the market.

    所以我認為總而言之,我們的開局非常強勁,我們期待著將下一個疫苗推向市場。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Okay. Thank you very, very much.

    好的。非常非常感謝你。

  • Operator

    Operator

  • Next, we have Chris Schott with JPMorgan.

    接下來,我們請摩根大通的 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Actually, kind of a qualitative question on how to think about OpEx dynamics going forward. It seems like we've seen some upward bias in spend at the company, which has kind of coincided with the ramp in COVID sales. I guess for a position where that COVID market resets as we transition past the pandemic, is there opportunity? Or should we think about a pullback in OpEx spend associated with that? Or should we think about these as more normalized levels of spend given all these growth initiatives that you're highlighting and investing behind at this point?

    實際上,這是一個關於如何考慮未來運營支出動態的定性問題。似乎我們已經看到該公司的支出出現了一些向上的偏見,這與 COVID 銷售的增長不謀而合。我猜想在我們度過大流行之後,COVID 市場會重置的位置,有機會嗎?還是我們應該考慮與此相關的運營支出支出的回落?還是我們應該將這些視為更正常的支出水平,因為您目前正在強調和投資的所有這些增長計劃?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Chris. Nice question. And our new CFO clearly has views on this. So Dave, what do you think?

    謝謝你,克里斯。好問題。我們的新首席財務官顯然對此有看法。那麼戴夫,你怎麼看?

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Chris, good question. Listen, before getting into -- it's probably a little too early for guidance for '23. But my expectation is that there would not be a pullback in expenses. I think if anything, what we're fortunate to have is a very robust launch schedule over the next 18 months. And we're really focused on investing to make sure that those launches are extremely successful and these medicines get in the hands of patients pretty quickly.

    克里斯,好問題。聽著,在進入之前——對於 23 年的指導可能還為時過早。但我的預期是開支不會出現回落。我認為,如果有的話,我們很幸運在接下來的 18 個月內擁有非常穩健的發佈時間表。我們真的專注於投資,以確保這些產品的推出非常成功,並且這些藥物很快就會到達患者手中。

  • And so if anything, our focus is to get behind these launches, make sure that we execute them flawlessly and that we see the ramp-up and drive our sales performance, particularly in the 2025 to 2030 time frame.

    因此,如果有的話,我們的重點是支持這些發布,確保我們完美地執行它們,並確保我們看到增長並推動我們的銷售業績,特別是在 2025 年至 2030 年的時間範圍內。

  • Operator

    Operator

  • Next is Geoff Meacham with Bank of America.

    接下來是美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • Thanks for the question. Just had a few. The slide on long-term growth is really helpful. On the $20 billion on Slide 9 that you guys have highlighted, can you talk to the long-term contribution that is not COVID? I know there's some -- there's a long-term piece for COVID, but most investors are focused on kind of the non-COVID drivers.

    謝謝你的問題。剛吃了幾個。長期增長的幻燈片真的很有幫助。關於你們在幻燈片 9 上強調的 200 億美元,你們能談談不是 COVID 的長期貢獻嗎?我知道有一些——COVID 有一個長期的部分,但大多數投資者都專注於非 COVID 驅動因素。

  • And then on I&I, looking to next year when we'll have many biosimilars launching for Humira, how much of market disruption do you think we'll see from higher buyers, similar volumes and payer preferences? I'm thinking about the effect on CIBINQO and then the etrasimod launch specifically, but also Xeljanz and Inflectra.

    然後在 I&I 方面,期待明年我們將為 Humira 推出許多生物仿製藥,您認為我們將從更高的買家、類似的數量和付款人偏好中看到多少市場破壞?我正在考慮對 CIBINQO 的影響,然後是 etrasimod 的推出,還有 Xeljanz 和 Inflectra。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. I will ask Angela to answer the second question. On the first one, maybe I can give some clarifications.

    是的。我會請安吉拉回答第二個問題。關於第一個,也許我可以澄清一下。

  • On the $20 billion, so we have included revenues from new launches. This is our estimations for 2030. New launches that are happening either started in '22, CIBINQO, for example, is there, because it started. And then we are adding claims or are about to happen and we have the list in the appendix. And in this list, excluding the BD, which we do not count over there, we count on the previous bar, where we have the $25 billion of revenues, are summing to $20 billion in our expectation.

    在 200 億美元上,我們已經包括了新產品發布的收入。這是我們對 2030 年的估計。正在發生的新發布要么開始於 22 年,例如 CIBINQO 就在那裡,因為它開始了。然後我們正在添加聲明或即將發生聲明,我們在附錄中有列表。在這個列表中,不包括我們沒有計算在內的 BD,我們計算上一個欄,我們有 250 億美元的收入,我們的預期總和為 200 億美元。

  • Just to clarify, this does not include COVID. This is excluding COVID, excluding new things that may come from COVID, excluding new things that may come in antivirals or new vaccines or combination vaccines or any of that. These are not part of that.

    澄清一下,這不包括 COVID。這不包括 COVID,不包括可能來自 COVID 的新事物,不包括可能來自抗病毒藥物或新疫苗或聯合疫苗或任何此類的新事物。這些不是其中的一部分。

  • Now in the other pipeline, which are things that are not in the near, near short term and things that will launch after the 18 months period all the way to '30, clearly, a lot of these things maybe are not known to you yet. But among the things that are known to you and that should be included over there, should be the GLP-1, should be any combinations between flu and COVID or RSV, should be our interferon [BIIM], and the Lyme vaccines, the Arvinas, should be the gene therapies that could come. All of that should count towards that bar that we haven't quantified yet publicly. Of course, we know what we expect ourselves. Thank you very much. Now, Angela. The I&I and the vaccine launch.

    現在在另一個管道中,這些東西不是在短期內,短期內以及將在 18 個月之後一直到 30 年推出的東西,很明顯,很多這些東西你可能還不知道.但是在你所知道的並且應該包括在那裡的東西中,應該是 GLP-1,應該是流感和 COVID 或 RSV 之間的任何組合,應該是我們的干擾素 [BIIM],以及萊姆疫苗,Arvinas ,應該是可能到來的基因療法。所有這些都應該計入我們尚未公開量化的那個標準。當然,我們知道我們對自己的期望。非常感謝。現在,安吉拉。 I&I 和疫苗的推出。

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • So the way to think about it is the biologics market and the oral market is -- the way we think about it is that it's different. And the reason I say that is because there is -- if you look at the treatment algorithms and how the biologics are used and how the orals are used, you picked Xeljanz as an example, right? Clearly, there, the label says that you have to have used anti-TNF before you move on to an oral JAK.

    所以思考它的方式是生物製劑市場和口服市場——我們思考它的方式是不同的。我之所以這麼說是因為有——如果你看看治療算法、生物製劑的使用方式以及口服藥物的使用方式,你選擇 Xeljanz 作為例子,對嗎?很明顯,標籤上說你必須先使用抗 TNF,然後才能繼續口服 JAK。

  • And so I don't think that the competition is across biologics. With orals, I think the competition is literally with HUMIRA and the biosimilars of Humira, and then the orals have their role.

    所以我不認為競爭是跨生物製劑的。對於口服,我認為競爭實際上是與 HUMIRA 和 Humira 的生物仿製藥,然後口服有它們的作用。

  • So I'll use Xeljanz as one example. I'll use etrasimod as another example. There, the benefit of this is that you have an oral therapy that actually can be used earlier line and actually pre-biologic. So again, there, you -- it's the different lines of treatment and the fact that I think there are distinct places where you would use an oral and a distinct place where you would use a biologic, and I don't think that's the crossover.

    所以我將使用 Xeljanz 作為一個例子。我將使用 etrasimod 作為另一個示例。在那裡,這樣做的好處是你有一種口服療法,它實際上可以用於更早的生產線並且實際上是前生物製劑。再說一次,你——這是不同的治療方法,我認為在不同的地方你會使用口服藥物,在不同的地方你會使用生物製劑,我不認為這是交叉.

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Angela. We're running a little bit late, so we'll have 3 more questions. And we'll try to make -- answer them very quickly.

    謝謝你,安吉拉。我們跑得有點晚了,所以我們還有 3 個問題。我們將嘗試做出- 非常快速地回答它們。

  • Operator

    Operator

  • Next is Terence Flynn with Morgan Stanley.

    接下來是摩根士丹利的特倫斯弗林。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • I was just wondering on PAXLOVID, it looks like there's going to be some doses remaining on the current U.S. contract as we head into 2023. So just maybe, I know you talked about how COMIRNATY would work as we move to a commercial market. But maybe just help us think about how that will work here in the U.S. as we transition out of the pandemic here.

    我只是想知道 PAXLOVID,看起來在我們進入 2023 年時,當前的美國合同中還會剩下一些劑量。所以也許,我知道你談到了 COMIRNATY 在我們進入商業市場時將如何運作。但也許只是幫助我們思考,隨著我們從這裡的大流行中過渡出來,這將如何在美國發揮作用。

  • And the second question I had is just any more detail you can share on the Prevnar data in peds regarding the serotype coverage? I know that was a question that came out post the Phase III data.

    我的第二個問題是,您可以在 peds 中的 Prevnar 數據中分享有關血清型覆蓋率的更多細節嗎?我知道這是在第三階段數據之後出現的一個問題。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Very quickly on the PAXLOVID, it is not very different than what is happening with the vaccine. There will be a transition period. We will have to announce the list price, then we have to work with the U.S. government to transition so that when they stop distributing their, let's say, goods that they have, we will, let's say, start and we have a seamless transition. So the market will always become covered.

    很快,在 PAXLOVID 上,它與疫苗的情況並沒有太大不同。會有一個過渡期。我們將不得不宣布定價,然後我們必須與美國政府合作進行過渡,以便當他們停止分發他們擁有的商品時,比如說,我們將開始,並且我們可以無縫過渡。所以市場總是會被覆蓋。

  • But we will give more details given these dynamics, what happens and when this happens, the transition at next -- in the guidance for next year. Mikael, anything you have to say on the pediatrics?

    但是,鑑於這些動態,我們將在明年的指導中提供更多詳細信息,包括發生什麼、何時發生、接下來的過渡。 Mikael,關於兒科,你有什麼要說的嗎?

  • Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

    Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

  • Just very brief that we have had positive studies in U.S. 3-plus-1 schedule, European Union 2-plus-1, after either 4 or 3 doses, which is the toddler complete schedule. We covered 20 serotypes in U.S. and 19 in the EU. But the totality of data across all endpoints, we believe, clearly speaks to that this is an important vaccine that adds coverage. And it's likely going to be the vaccine in the near term and for quite many years that have the broadest coverage.

    非常簡短地說,我們在美國 3+1 計劃、歐盟 2+1 計劃中進行了積極的研究,在 4 或 3 劑之後,這是幼兒完整計劃。我們涵蓋了美國的 20 种血清型和歐盟的 19 种血清型。但我們認為,所有端點的全部數據清楚地表明這是一種增加覆蓋率的重要疫苗。而且它很可能在短期內成為覆蓋面最廣的疫苗。

  • Operator

    Operator

  • Next, we have Chris Shibutani with Goldman Sachs.

    接下來是高盛的 Chris Shibutani。

  • Chris Shibutani - Research Analyst

    Chris Shibutani - Research Analyst

  • In terms of RSV, if you could share some thoughts in terms of the velocity of the uptake that you're expecting? Is flu a good barometer? And how quickly do you think, if that's the case, that we could possibly reach through?

    就 RSV 而言,您能否就您所期望的吸收速度分享一些想法?流感是一個好的晴雨表嗎?如果是這樣的話,你認為我們能以多快的速度到達?

  • And then with etrasimod, in the previous owner's hands, there were additional opportunities, I believe, Crohn's disease data, Phase II; atopic dermatitis, Phase III, were originally in the time lines for calendar 2022. Will we get some insights on that -- on those clinical programs?

    然後用 etrasimod,在之前的所有者手中,我相信,克羅恩病數據,第二階段,還有更多的機會;特應性皮炎 III 期最初是在 2022 年的時間線上。我們會對此有一些見解——關於那些臨床項目嗎?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. I will ask -- actually, for the clinical programs, William, to speak a little bit about that.

    是的。我會問——實際上,對於臨床項目,威廉,就這一點談一談。

  • William Pao - Executive VP & Chief Development Officer

    William Pao - Executive VP & Chief Development Officer

  • Yes. Sure. For etrasimod, we have nothing new to update at this time, Chris.

    是的。當然。對於 etrasimod,我們目前沒有任何新內容要更新,克里斯。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • All right. And then for RSV, I would say, clearly, we think that it could become like flu-like. I think all respiratory disease eventually will have coverage like we have right now in flu. The question is how often that will happen. And that will depend on several factors. Education, of course, of the people and their physicians, but also the availability of combination programs and products that could significantly bring all 3 of them together, RSV, COVID and flu.

    好的。然後對於 RSV,我會說,很明顯,我們認為它可能變得像流感一樣。我認為所有呼吸系統疾病最終都會像我們現在的流感一樣得到覆蓋。問題是這種情況多久會發生一次。這將取決於幾個因素。當然,人們和他們的醫生的教育,還有組合計劃和產品的可用性,這些組合計劃和產品可以顯著地將這三者結合在一起,RSV、COVID 和流感。

  • Operator

    Operator

  • Next, we have Umer Raffat with Evercore ISI.

    接下來,我們邀請了 Evercore ISI 的 Umer Raffat。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I wanted to ask 2 questions on pricing today, if I may. Perhaps first one, Albert, I know the COVID vaccine repricing was a very bold decision. And I understand the dynamics around the value proposition, the pandemic versus endemic era pricing, et cetera. But I think the sheer magnitude of the increase is making a lot of investors ask questions around ESG implications, any political blowback, et cetera. I'm just curious how you guys thought about this very important decision and how you're thinking about the expectation on net pricing.

    如果可以的話,我今天想問兩個關於定價的問題。也許第一個,阿爾伯特,我知道重新定價 COVID 疫苗是一個非常大膽的決定。而且我了解價值主張、大流行與流行時代定價等方面的動態。但我認為,增長幅度之大讓許多投資者就 ESG 影響、任何政治反擊等問題提出疑問。我只是好奇你們如何看待這個非常重要的決定,以及你們如何看待對淨定價的期望。

  • And then separately, on PAXLOVID. I know you're running a 10-day trial versus the 5-day course that's currently approved. Does that mean PAXLOVID will effectively become 2x the price once a 10-day course is approved?

    然後分別在 PAXLOVID 上。我知道您正在進行為期 10 天的試用,而不是目前批准的 5 天課程。這是否意味著一旦批准了為期 10 天的課程,PAXLOVID 將有效地成為價格的 2 倍?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. I can answer both of them. Look, I think what was very bold and the right absolutely decision was to price the PAXLOVID during the pandemic at a very, very, very low price. Clearly, the price that -- excuse me, the vaccine at a very, very low price. That was the right thing to do, and we did it and we maintained that for the years to come.

    是的。我可以回答他們兩個。看,我認為非常大膽且絕對正確的決定是以非常、非常、非常低的價格在大流行期間對 PAXLOVID 進行定價。很明顯,價格——對不起,疫苗的價格非常非常低。這是正確的做法,我們做到了,並且在未來的幾年裡一直保持著這一點。

  • Now that we are coming to the end of this period and as we are moving to very different product, which has very different presentations, which are -- now we are moving to single instead of mass vial, multi-dose vial, we are pricing the vaccine according to the cost effectiveness. And the cost effectiveness of the current vaccine, the way that CDC is pricing it, is way, way, way below than what the price that we have set at $110 and $130.

    既然我們即將結束這個時期,並且我們正在轉向非常不同的產品,它有非常不同的展示方式,現在我們正在轉向單一而不是批量小瓶,多劑量小瓶,我們正在定價疫苗根據成本效益。當前疫苗的成本效益,CDC 定價的方式,遠遠低於我們設定的 110 美元和 130 美元的價格。

  • Also, keep in mind that people will not see any difference and the system will get the benefit of a cost-effective product. And the people wouldn't see any difference because there's no copay.

    此外,請記住,人們不會看到任何差異,系統將受益於具有成本效益的產品。人們不會看到任何區別,因為沒有共付額。

  • Now on the PAXLOVID, I think it's too early to speak. We haven't announced any price. And we do not know what will be the outcome of the studies or the outcome of a new class that is coming following PAXLOVID.

    現在在 PAXLOVID 上,我認為現在發言還為時過早。我們還沒有公佈任何價格。而且我們不知道研究的結果或 PAXLOVID 之後即將推出的新課程的結果。

  • Operator

    Operator

  • Our last question will come from David Risinger with SVB Securities.

    我們的最後一個問題將來自 SVB 證券的 David Risinger。

  • David Reed Risinger - Senior MD

    David Reed Risinger - Senior MD

  • So my two questions are regarding the core growth, which was 2% operationally in the third quarter, could you talk about what you're assuming and how we should think about growth prospects in the future, specifically in the fourth quarter since you've guided to that in your updated guidance?

    所以我的兩個問題是關於核心增長,第三季度的運營增長率為 2%,您能否談談您的假設以及我們應該如何考慮未來的增長前景,特別是在第四季度,因為您已經在您更新的指南中對此有指導嗎?

  • And then second, could you provide an update -- and I might have missed this, if I did, I apologize. But could you provide an update on your next-gen oral antiviral for COVID?

    其次,您能否提供更新——我可能錯過了這一點,如果我這樣做了,我深表歉意。但是,您能否提供有關您的下一代 COVID 口服抗病毒藥物的最新信息?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you. One, on the 2% operational, excluding COVID, just to make a clarification, if you exclude also the contract manufacturing business that we have that was really COVID-related, it has very increased revenues last year because we were contract manufacturing for BioNTech territories that we don't have to do now because BioNTech took over for their territories their own manufacturing. In fact, the growth was 4% of our pharmaceutical business, excluding COVID and excluding this piece of contract manufacturing. Now Angela, based on that, what will we expect to be the growth trajectory?

    謝謝你。一,關於 2% 的運營,不包括 COVID,只是為了澄清一下,如果你也排除了我們真正與 COVID 相關的合同製造業務,它去年的收入非常增加,因為我們是 BioNTech 地區的合同製造我們現在不必這樣做,因為 BioNTech 在他們的領土上接管了他們自己的製造。事實上,我們的製藥業務增長了 4%,不包括 COVID 和這部分合同製造。現在安吉拉,基於此,我們期望的增長軌跡是什麼?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Well, we've talked about our 5-year CAGR, right, to be 6%. And just I want to reiterate that, that is exactly the track that we're on. Every year does not necessarily have to look identical. But over the 5-year period, we're absolutely confident that we're going to deliver the 6% CAGR.

    好吧,我們已經談到了我們的 5 年復合年增長率,對,是 6%。我只想重申這一點,這正是我們正在走的軌道。每年不一定要看起來相同。但在 5 年期間,我們絕對有信心實現 6% 的複合年增長率。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • All right. So thank you very much. So with that, I think we are close to bring our call to a close. Please don't forget to attend our event on December 12, where we will provide details about our very important new product launches in the next 18 months in some of our most important pipeline, potential new medicines and vaccines. Thank you for joining us today. Have a great rest of your day.

    好的。所以非常感謝。因此,我認為我們即將結束我們的呼籲。請不要忘記參加 12 月 12 日的活動,屆時我們將詳細介紹我們在未來 18 個月內推出的一些最重要的新產品、潛在的新藥和疫苗。感謝您今天加入我們。好好休息一天。

  • Operator

    Operator

  • Ladies and gentlemen, this does conclude today's earnings call, and we appreciate your participation. You may now disconnect.

    女士們先生們,今天的財報電話會議到此結束,我們感謝您的參與。您現在可以斷開連接。