輝瑞 (PFE) 2022 Q1 法說會逐字稿

Good day, everyone, and welcome to Pfizer's First Quarter 2022 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to 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 年第一季度收益電話會議。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。請繼續，先生。

Thank you, operator. Good morning. Welcome to Pfizer's first quarter earnings call. I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Frank D'Amelio, our CFO; and Mikael Dolsten, President of Worldwide Research and Development and Medical. Joining us for the Q&A session, we will also have Angela Hwang, Group President, Pfizer Biopharmaceuticals Group; Aamir Malik, our Chief Business and Innovation Officer; Doug Lankler, our General Counsel; and William Pao, our new Chief Development Officer.

謝謝你，接線員。早上好。歡迎來到輝瑞公司第一季度財報電話會議。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 Frank D'Amelio；以及全球研發和醫療總裁 Mikael Dolsten。參加問答環節的還有輝瑞生物製藥集團總裁 Angela Hwang； Aamir Malik，我們的首席業務和創新官；我們的總法律顧問 Doug Lankler；和我們新任首席開發官 William Pao。

The 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 3 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 Statements. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements. With that, I will turn the call over to Albert.

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。請參閱幻燈片 3 上的前瞻性聲明免責聲明以及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，請參閱我們的收益發布和風險因素和前瞻性聲明下的 SEC 10-K 和 10-Q 表格.關於電話會議的前瞻性陳述存在重大風險和不確定性，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陳述的義務。有了這個，我會把電話轉給阿爾伯特。

Thank you, Chris, and good morning, everyone. Pfizer had what a solid start to the year. Revenues were up 82% operationally compared with the first quarter of 2021. Key growth drivers for the quarter included COMIRNATY, PAXLOVID, Eliquis, VYNDAQEL/VYNDAMAX globally, our Prevnar family of vaccines and our oncology biosimilars portfolio in the U.S. Overall, we reached an estimated 468 million patients around the world only in 1 quarter with our innovative medicines and vaccines, which represent a 140% increase from the prior year quarter, and it is a testament to our purpose, breakthroughs that change patients' lives.

謝謝你，克里斯，大家早上好。輝瑞公司今年開局不錯。與 2021 年第一季度相比，運營收入增長了 82%。本季度的主要增長動力包括全球 COMIRNATY、PAXLOVID、Eliquis、VYNDAQEL/VYNDAMAX、我們的 Prevnar 系列疫苗和我們在美國的腫瘤生物仿製藥產品組合。總體而言，我們達到了據估計，僅在 1 個季度，全球就有 4.68 億患者使用我們的創新藥物和疫苗，比去年同期增長 140%，這證明了我們的目標，即改變患者生活的突破。

We continue to supply the world with COMIRNATY, which remains a critical tool in helping prevent severe illness, hospitalization and deaths from COVID-19. Today, we have shipped nearly 3.4 billion doses of our vaccine to 179 countries. COMIRNATY is the most utilized mRNA vaccine in the markets in which we operate and (inaudible). Pfizer's cumulative share of doses administered in these markets has increased in fact from 52% that used to be on January 1, beginning of the year 2022, to 62% on May 1, 2022. Just a few months, 10 points. In developed markets, our share has increased from 59% to 67% over that same period of time.

我們繼續向世界提供 COMIRNATY，它仍然是幫助預防 COVID-19 導致的重病、住院和死亡的關鍵工具。今天，我們已向 179 個國家/地區運送了近 34 億劑疫苗。 COMIRNATY 是我們經營所在市場和（聽不清）中使用最多的 mRNA 疫苗。輝瑞在這些市場上的累計給藥劑量實際上已從 2022 年初 1 月 1 日的 52% 增加到 2022 年 5 月 1 日的 62%。僅僅幾個月，10 個百分點。在發達市場，我們的份額同期從 59% 增加到 67%。

We also have had a strong start to the year with regard to regulatory milestones, including the Emergency Use Authorization from the U.S. FDA and Conditional Market Authorization from EMA for our 12- to 15-year old booster dose. We had an EUA from the FDA for a second booster (inaudible) in patients 50 years of age and older and 12 years of age and older who are immunocompromised. And we had an extension to a 12-month frozen shelf life label 12 months from both the FDA and the EMA. Our ambition is to eventually achieve a 24-month shelf life, which would help alleviate concerns that some governments may have about having expiring dose system.

今年我們在監管里程碑方面也有一個強勁的開端，包括美國 FDA 的緊急使用授權和 EMA 對我們 12 至 15 歲加強劑量的有條件市場授權。我們從 FDA 獲得了 EUA，用於對 50 歲及以上和 12 歲及以上免疫功能低下的患者進行第二次加強免疫（聽不清）。我們從 FDA 和 EMA 處延長了 12 個月的冷凍保質期標籤 12 個月。我們的目標是最終實現 24 個月的保質期，這將有助於緩解一些政府可能對過期劑量系統的擔憂。

In addition to the U.S. and the EU, we now have authorizations for the 5 to 11 age group in 44 other markets around the world. In addition, we have recently released new results from a Phase II/III clinical trial, demonstrating that the 10-microgram booster dose of our vaccine in healthy children 5 to 11 years of age increases geometric mean neutralizing antibody titer -- geometric mean neutralizing antibody titers, wild-type and Omicron variants. Based on this data, last week, we submitted an application to the FDA for an EUA of a 10-microgram booster dose for children in this age group, and we look forward to filing in other jurisdictions in the near future.

除了美國和歐盟，我們現在在全球 44 個其他市場擁有 5 至 11 歲年齡段的授權。此外，我們最近發布了一項 II/III 期臨床試驗的新結果，表明我們的疫苗在 5 至 11 歲的健康兒童中的 10 微克加強劑量增加了幾何平均中和抗體滴度 - 幾何平均中和抗體滴度、野生型和 Omicron 變體。基於這些數據，上週，我們向 FDA 提交了一份針對該年齡段兒童的 10 微克加強劑量的 EUA 申請，我們期待在不久的將來在其他司法管轄區提交申請。

We also expect to share data on our ongoing study in children who are 6 months to under 5 years of age in the next few weeks. This study is looking at the safety and efficacy of 3 doses of the vaccine in this age group, and we hope to submit an application for an EUA soon, pending the results of the data readout, of course. Last, we stand ready to support boosting authorized populations today as well as in the fall ahead of the traditional flu season. Independent real-world evidence from several countries have demonstrated that our booster doses improve protection that may have waned from the primary vaccination or since the first booster.

我們還希望在接下來的幾週內分享我們正在進行的針對 6 個月至 5 歲以下兒童的研究數據。這項研究正在研究這個年齡段的 3 劑疫苗的安全性和有效性，我們當然希望盡快提交 EUA 申請，等待數據讀出的結果。最後，我們隨時準備支持在今天以及在傳統流感季節之前的秋季增加授權人口。來自多個國家的獨立真實世界證據表明，我們的加強劑量提高了可能從初次接種疫苗或自第一次加強免疫開始減弱的保護。

Our market reserves shows that greater than 96% of health care provider respondents in key markets like the U.S. and the EU5 largest markets, continue to recommend a third dose booster to their patients. We also have seen an upward trend in uptake of a third dose booster in various developed markets. In these same markets that I referred previously, 74% of people who have received the initial 2-dose regimen reported that they have all already received third dose booster. And the remaining 13% of the respondents said that they are very likely to receive a booster. We believe this is an encouraging leading indicator for the potential uptake of a fourth dose. We also continue to evaluate potential next-generation vaccines, including variant vaccines to provide broad coverage for the fall, and we look forward to evaluating and sharing these data in the coming months.

我們的市場儲備表明，在美國和歐盟 5 大市場等主要市場中，超過 96% 的醫療保健提供者受訪者繼續向他們的患者推薦第三劑加強劑。我們還看到，在各個發達市場，第三劑加強劑的使用呈上升趨勢。在我之前提到的這些相同市場中，74% 的接受過初始 2 劑方案的人報告說他們都已經接受了第三劑加強劑。剩下的 13% 的受訪者表示他們很有可能會接受助推器。我們認為這是一個令人鼓舞的領先指標，表明第四劑的潛在攝入量。我們還將繼續評估潛在的下一代疫苗，包括為秋季提供廣泛覆蓋的變異疫苗，我們期待在未來幾個月內評估和分享這些數據。

We are also delivering on our commitments for PAXLOVID, which is already having a profoundly positive impact on the lives of patients around the world. Through the end of March, we produced more than 6 million treatment courses, all of which have been shipped shortly after they were produced. Because the financial calendar quarter for international markets ends in February and the majority of these 6 million treatments were produced in March, only a small portion of these shipments were recorded in our first quarter revenues. In fact, as of today, we have shipped approximately 8 million treatment courses.

我們還兌現了對 PAXLOVID 的承諾，它已經對世界各地患者的生活產生了深遠的積極影響。截至 3 月底，我們生產了超過 600 萬個療程，所有療程均在生產後不久發貨。由於國際市場的財務日曆季度在 2 月結束，而這 600 萬種治療方法中的大部分是在 3 月生產的，因此這些出貨量中只有一小部分記錄在我們第一季度的收入中。事實上，截至今天，我們已經運送了大約 800 萬個療程。

Our manufacturing ramp-up is progressing as planned, and we are on track to produce 24 million courses in the second quarter for a total of 30 million in the first half of the year. All of these quantities have already been allocated to existing orders. In addition, we remain on track to produce 120 million courses for the full year, as previously stated. To date, PAXLOVID has received regulatory approvals for temporary authorization for use with certain populations in more than 60 countries. We continue to have discussions with governments and regulatory agencies around the world about bringing this potential breakthrough treatment to additional markets.

我們的製造產能正在按計劃進行，我們有望在第二季度生產 2,400 萬門課程，在今年上半年共生產 3,000 萬門課程。所有這些數量都已分配給現有訂單。此外，如前所述，我們仍有望全年生產 1.2 億門課程。迄今為止，PAXLOVID 已獲得監管批准，可在 60 多個國家/地區用於特定人群的臨時授權。我們將繼續與世界各地的政府和監管機構討論將這種潛在的突破性療法推向更多市場。

Some countries that they have experienced recent outbreaks have come back to us to request additional treatment courses, which we are responding to with urgency. Others are taking steps to expand access. For example, the Italian government recently announced an expansion of prescribing into primary care. We believe this shift from having only specialists prescribe PAXLOVID will help ensure more patients get access at the right time.

一些最近爆發疫情的國家已經向我們提出請求，要求提供額外的治療課程，我們正在緊急應對。其他人正在採取措施擴大訪問範圍。例如，意大利政府最近宣布將處方擴大到初級保健。我們相信，這種從只讓專家開 PAXLOVID 的轉變將有助於確保更多患者在正確的時間獲得治療。

In the U.K. PAXLOVID will now be included in the National Panoramic Study, which we expect will increase access and collect further data regarding how the therapy works in a market where the majority of the adult population is vaccinated. This is important because today, the U.K. has restricted PAXLOVID use to a very limited populace. And this study could lead to government to open up access to a much broader population closer to the authorized populations.

在英國，PAXLOVID 現在將被納入國家全景研究，我們預計這將增加訪問並收集有關該療法如何在大多數成年人口接種疫苗的市場中發揮作用的進一步數據。這很重要，因為今天，英國已將 PAXLOVID 的使用限制在非常有限的人群中。這項研究可能會導致政府向更接近授權人口的更廣泛的人口開放。

In Canada, we expect increasing supply and the lifting of COVID-19 restrictions will enable greater access for patients across the country. Quebec and Ontario, which represent the 2 largest provinces and are home to more than 60% of Canada's population, have expanded distribution to eligible pharmacies, allowed pharmacists to prescribe and started a comprehensive direct-to-consumer and social media campaign to ensure all eligible patients are aware of the availability of PAXLOVID.

在加拿大，我們預計供應的增加和 COVID-19 限制的解除將使全國各地的患者獲得更多的機會。代表加拿大 60% 以上人口的兩個最大省份魁北克省和安大略省已擴大對符合條件的藥房的分銷，允許藥劑師開處方，並開展了全面的直接面向消費者和社交媒體的活動，以確保所有符合條件的患者知道 PAXLOVID 的可用性。

Here in the U.S., we have seen PAXLOVID utilization grow nearly 10-fold in recent weeks. PAXLOVID was administered to more than 79,000 patients in the U.S. that weekend in April 27, up from approximately 8,000 patients for the weekend in February 25, 2022. We will continue to work with the U.S. government and health care providers to appropriately drive even higher utilization. And based on data from IQVIA Xponent, PAXLOVID market share relative to molnupiravir in the retail long-term care and mail order channels grew from 44% in the weekend in January 28, 2022, to almost 90% in the week ending April 22, 2022. Together, these channels represent an estimated 50% of PAXLOVID utilization in the U.S.

在美國，我們看到最近幾週 PAXLOVID 的使用量增長了近 10 倍。 4 月 27 日那個週末，美國有超過 79,000 名患者接受了 PAXLOVID，高於 2022 年 2 月 25 日那個週末的大約 8,000 名患者。我們將繼續與美國政府和醫療保健提供者合作，以適當提高利用率.根據 IQVIA Xponent 的數據，PAXLOVID 在零售長期護理和郵購渠道中相對於莫努匹拉韋的市場份額從 2022 年 1 月 28 日週末的 44% 增長到截至 2022 年 4 月 22 日當週的近 90% . 這些渠道合計占美國 PAXLOVID 使用率的 50%。

The number of locations in the U.S. with PAXLOVID supply continues to increase with more than 33,000 sites live as of today. This is more than a fourfold increase since late February, leading to easier patient access. The U.S. government declared its intention to double the size again in the coming weeks and making PAXLOVID available to any pharmacy who wishes to stock.

美國有 PAXLOVID 供應的地點數量繼續增加，截至今天已有 33,000 多個地點。自 2 月下旬以來，這一數字增加了四倍多，從而使患者更容易獲得治療。美國政府宣布打算在未來幾週內再次將規模擴大一倍，並將 PAXLOVID 提供給任何希望庫存的藥房。

In addition, 77% of recent U.S. COVID-19 cases occurred within 5 miles of the closest retail point of care, which is up from only 23% since February. We expect this trend to continue to increase, driven by the U.S. government's Test to Treat initiative. For example, nearly 1,100 more Test to Treat locations have been added since the beginning of April on. Today, there are more than 2,200 locations of Test to Treat open. Overall, we expect the recent trends to expand access as well as inquiries received from governments as the virus mutates and cause spikes in infections around the world to result in increased orders in the coming months as governments continue to help protect their citizens who are at high risk of severe disease, hospitalization and death in response to emerging variants and continuing outbreaks.

此外，最近 77% 的美國 COVID-19 病例發生在距離最近的零售點 5 英里範圍內，而自 2 月份以來這一比例僅為 23%。在美國政府的“治療測試”倡議的推動下，我們預計這一趨勢將繼續增加。例如，自 4 月初以來，已經增加了近 1,100 個 Test to Treat 地點。今天，有 2,200 多個 Test to Treat 營業地點。總體而言，我們預計，隨著病毒變異並導致世界各地感染人數激增，隨著政府繼續幫助保護處於高危狀態的公民，未來幾個月的訂單將增加，我們預計最近的趨勢將擴大訪問範圍以及從政府收到的詢問應對新出現的變異和持續爆發的嚴重疾病、住院和死亡風險。

Now I will turn to our business development strategy. We leverage business development opportunities to advance our business strategies and objectives. We recently announced positive top line results from a year-long Phase III trial of etrasimod in moderately to severely active ulcerative colitis. These results underscore Pfizer's ability to identify strong business development targets as this potentially best-in-class drug candidate came to us via our recent acquisition of Arena. We look forward to presenting this data and filing for approval later this year.

現在我將轉向我們的業務發展戰略。我們利用業務發展機會來推進我們的業務戰略和目標。我們最近公佈了一項為期一年的依曲莫德治療中度至重度活動性潰瘍性結腸炎的 III 期試驗的積極頂線結果。這些結果強調了輝瑞確定強大的業務發展目標的能力，因為這種潛在的同類最佳候選藥物是通過我們最近收購 Arena 來找我們的。我們期待在今年晚些時候提供這些數據並提交批准。

First quarter, we discussed how the strength of our balance sheet and cash flows gives us the ability to pursue new business development opportunities that, if successful, could add at least $25 billion of risk-adjusted revenues to our 2030 top line expectations. Our planned acquisition of ReViral is the first deal to be counted towards this ambition. ReViral is a privately-held clinical stage biopharmaceutical company focused on discovering, developing and commercializing novel antiviral therapeutics that target respiratory syncytial virus. Basically, they target RSV. We believe annual revenue from these programs, if successful, has the potential to reach or exceed $1.5 billion. This is peak revenues.

第一季度，我們討論了我們的資產負債表和現金流的實力如何使我們有能力尋求新的業務發展機會，如果成功，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。我們計劃收購 ReViral 是實現這一雄心壯志的第一筆交易。 ReViral 是一家私人持有的臨床階段生物製藥公司，專注於發現、開發和商業化針對呼吸道合胞病毒的新型抗病毒療法。基本上，它們以 RSV 為目標。我們相信這些項目的年收入如果成功，有可能達到或超過 15 億美元。這是最高收入。

We also are excited about the prospect of adding several experienced virologists to our team. Building relationship within the growing biotech ecosystem remains a priority for Pfizer. We continue to pursue new creative ways of partnering with biotechs to increase our access to cutting-edge innovation and to bring our resources to help drive for patients. We believe our scientific expertise, our end-to-end development and manufacturing capabilities makes us an extremely attractive partner. I see, for example, through our relationship with BioNTech, and we are confident that we have the financial resources to support business development opportunities that will complement and enhance our internal R&D efforts and add capacity and flexibility to support our growing clinical portfolio.

我們也對在我們的團隊中增加幾位經驗豐富的病毒學家的前景感到興奮。在不斷發展的生物技術生態系統中建立關係仍然是輝瑞的首要任務。我們將繼續尋求與生物技術公司合作的創新方式，以增加我們獲得尖端創新的機會，並利用我們的資源幫助推動患者發展。我們相信我們的科學專業知識、端到端的開發和製造能力使我們成為極具吸引力的合作夥伴。例如，我看到，通過我們與 BioNTech 的關係，我們有信心擁有財務資源來支持業務發展機會，這將補充和加強我們的內部研發工作，並增加能力和靈活性以支持我們不斷增長的臨床產品組合。

Next, I would like to discuss some of our recent ESG highlights. First, we announced in February the results of Pfizer's third annual pay equity study in which a recognized compensation expert confirmed equitable pay practices for employees at Pfizer. The results indicated that Pfizer compensates female colleagues at a level that it is greater than 99% of what male colleagues are paid across the globe. Additionally, in the U.S., minorities are paid at dollar-for-dollar parity of what non-minorities are paid.

接下來，我想討論一下我們最近的一些 ESG 亮點。首先，我們在 2 月公佈了輝瑞第三次年度薪酬公平研究的結果，其中一位公認的薪酬專家證實了輝瑞員工的公平薪酬做法。結果表明，輝瑞公司對女同事的薪酬水平高於全球男同事薪酬的 99%。此外，在美國，少數族裔的薪酬與非少數族裔的薪酬相同。

When you look at Pfizer's median pay for women globally, it is in high 102.3% for the median pay of males. However, when you look at the median pay for minorities in the U.S. workforce, it is 85.5% of the median pay for our non-minorities. This median rate pay gap is an area we are actively addressing and that we expect to narrow.

當您查看輝瑞全球女性薪酬中位數時，男性薪酬中位數高達 102.3%。但是，當您查看美國勞動力中少數族裔的工資中位數時，它是我們非少數族裔工資中位數的 85.5%。這個中位數工資差距是我們正在積極解決的一個領域，我們預計會縮小。

Second, I want to reiterate that Pfizer stands with a unified global community in opposition to Russia's invasion to Ukraine. While Pfizer is maintaining our supply of medicine to Russians, as we should, we will be donating all profits of our Russian subsidiary to causes that provide direct humanitarian support to the people of Ukraine. Additionally, we will no longer initiate new clinical trials in Russia and will stop recruiting new patients in our ongoing clinical trials in the country.

其次，我想重申，輝瑞公司與一個統一的國際社會站在一起，反對俄羅斯入侵烏克蘭。在輝瑞公司繼續向俄羅斯人供應藥品的同時，我們應該將俄羅斯子公司的所有利潤捐贈給為烏克蘭人民提供直接人道主義支持的事業。此外，我們將不再在俄羅斯啟動新的臨床試驗，並將停止在該國正在進行的臨床試驗中招募新患者。

Pfizer will work with the FDA and other regulators to transition all ongoing clinical trials to alternative sites outside Russia. And consistent with our commitment to putting patients first, we will continue providing needed medicines to the patients already enrolled in clinical trials in Russia. Lastly, we are ceasing all future investments with local suppliers intended to build manufacturing capacity in Russia.

輝瑞將與 FDA 和其他監管機構合作，將所有正在進行的臨床試驗轉移到俄羅斯以外的其他地點。根據我們將患者放在首位的承諾，我們將繼續為已在俄羅斯參加臨床試驗的患者提供所需的藥物。最後，我們將停止與當地供應商的所有未來投資，以在俄羅斯建立製造能力。

Third, further demonstrating our commitment to equitable access, we have made the decision that for as long as the pandemic lasts, Pfizer will not profit from sales of our COVID-19 treatment to the world's poorest countries. In March, Pfizer announced an agreement with UNICEF to supply up to 4 million treatment courses of PAXLOVID to 95 low- and middle-income countries. Under the agreement, all low and lower middle-income countries will be offered the treatment courses at a not-for-profit price, while upper middle-income countries will pay a price defined in Pfizer's tier pricing approach.

第三，進一步表明我們對公平獲取的承諾，我們決定，只要大流行持續，輝瑞就不會從向世界上最貧窮國家銷售我們的 COVID-19 治療藥物中獲利。 3 月，輝瑞宣布與聯合國兒童基金會達成協議，向 95 個低收入和中等收入國家提供多達 400 萬個療程的 PAXLOVID。根據該協議，所有低收入和中低收入國家都將以非營利性價格獲得治療課程，而中高收入國家將支付輝瑞分級定價方法中定義的價格。

Lastly, I'm pleased to share that Pfizer continues to be recognized as an ethical patient-focused company that calls itself in its employees and its business partners to high standards. In March, Pfizer was recognized as one of the world's most ethical companies by Ethisphere, a global leader in defining and advancing the standards of ethical business practices. And just last week, and we are so proud about it, for the first time ever, Pfizer ranked first among big pharma companies in the PatientView global survey in 2021. This ranking is based on feedback from more than 2,000 patient organizations and associations worldwide. As recently as 2018, we were ranked fifth, and we have steadily climbed in the rankings ever since but we are so proud that we are #1 right now.

最後，我很高興地分享輝瑞公司繼續被公認為一家以患者為中心的道德公司，它以高標準要求其員工和業務合作夥伴。 3 月，輝瑞公司被 Ethisphere 評為全球最具道德的公司之一，Ethisphere 是定義和推進道德商業實踐標準的全球領導者。就在上週，我們為此感到非常自豪，輝瑞在 2021 年 PatientView 全球調查中首次在大型製藥公司中排名第一。該排名基於全球 2,000 多個患者組織和協會的反饋。就在 2018 年，我們排名第五，從那以後我們的排名穩步攀升，但我們很自豪我們現在排名第一。

Now I would like to welcome 2 new members of Pfizer executive leadership team. Dr. William Pao joined us on March 21 as Executive Vice President and Chief Development Officer. Throughout his 25-year career as an oncologist and scientist, William has amassed extensive clinical and deep scientific expertise that make him the ideal partner to continue our pursuit in breakthrough medicines and vaccines for the benefit of patients and society.

現在我要歡迎輝瑞執行領導團隊的 2 位新成員。 William Pao 博士於 3 月 21 日加入我們，擔任執行副總裁兼首席開發官。在他作為腫瘤學家和科學家的 25 年職業生涯中，William 積累了廣泛的臨床和深厚的科學專業知識，這使他成為繼續追求突破性藥物和疫苗以造福患者和社會的理想合作夥伴。

Just yesterday, David Denton joined us as Chief Financial Officer and Executive Vice President. Dave brings with him more than 25 years of finance and operational expertise, including more than 20 years in the health care sector. As a result, he brings to Pfizer a unique perspective on the role of payers, the needs of patients and the rapidly evolving health care landscape. We are thrilled to welcome these 2 highly effective and visionary leaders at this critical time for our company in global health.

就在昨天，David Denton 以首席財務官和執行副總裁的身份加入我們。 Dave 擁有超過 25 年的財務和運營專業知識，其中包括 20 多年的醫療保健行業經驗。因此，他為輝瑞帶來了關於付款人角色、患者需求和快速發展的醫療保健領域的獨特視角。在我們公司在全球健康領域的關鍵時刻，我們很高興歡迎這兩位高效且富有遠見的領導人。

And now before I hand it over to Mikael, I want to take a moment to thank Frank D'Amelio, my best friend in Pfizer, for his many contributions to Pfizer. In addition to helping ensure Pfizer's financial strength and discipline, Frank has been an incredible mentor to many of Pfizer's current leaders, helped save our long-term growth strategy and worked tirelessly to ensure Pfizer has the resources it needs to help improve the lives of patients around the world. Frank, on behalf of all Pfizer colleagues and I'm sure all the analysts on today's call and not only, I wish you continued good health and success.

現在，在我把它交給 Mikael 之前，我想花一點時間感謝我在輝瑞最好的朋友 Frank D'Amelio，感謝他對輝瑞的許多貢獻。除了幫助確保輝瑞的財務實力和紀律之外，弗蘭克一直是輝瑞許多現任領導人的不可思議的導師，幫助挽救了我們的長期增長戰略，並不知疲倦地工作以確保輝瑞擁有幫助改善患者生活所需的資源世界各地。弗蘭克，我代表輝瑞的所有同事，我相信今天電話會議的所有分析師，不僅祝你身體健康，取得成功。

With that, I will turn it over to Mikael to update you on the R&D efforts. After Mikael, Frank will provide financial details on the first quarter and our outlook for the remainder of 2022. Mikael?

有了這個，我將把它交給 Mikael 向您介紹研發工作的最新情況。在 Mikael 之後，Frank 將提供第一季度的財務細節以及我們對 2022 年剩餘時間的展望。Mikael？

Thank you, Albert. I'd like to start by highlighting 2 recent external acknowledgment of Pfizer's R&D turnaround. Pfizer was ranked first for innovation in the 11th Annual Pharmaceutical Innovation and Invention Index and first for what Forbes termed Total R&D Productivity over 20 Years in a paper published in by Discovery today. This is a testament not only to the work of our scientists over the past year but our purposeful efforts to improve our R&D engine over the past 10 years.

謝謝你，阿爾伯特。我想首先強調輝瑞公司研發轉型的兩個近期外部認可。輝瑞在第 11 屆年度藥物創新和發明指數中的創新排名第一，並且在今天由 Discovery 發表的一篇論文中被福布斯稱為“20 年的總研發生產力”。這不僅證明了我們科學家在過去一年中的工作，而且證明了我們在過去 10 年中為改進研發引擎所做的有目的的努力。

Today, I will share updates on COVID-19, inflammation and immunology, RSV, oncology, Lyme disease and hemophilia. In some cases, I may reference publicly available data on other agents so that you can understand our enthusiasm about what we're seeing in our development programs. Of course, head-to-head clinical trials would be necessary to support any comparative claims.

今天，我將分享有關 COVID-19、炎症和免疫學、RSV、腫瘤學、萊姆病和血友病的最新信息。在某些情況下，我可能會參考其他代理的公開可用數據，以便您了解我們對我們在開發計劃中看到的內容的熱情。當然，需要進行面對面的臨床試驗來支持任何比較主張。

We continue to pursue a comprehensive and data-driven clinical strategy for COMIRNATY, focused on evaluating real-world vaccine effectiveness, demonstrating higher immunogenicity with boosters, expanding access to pediatric population and addressing emerging variants of concern. On the left, in the Phase II/III trial of COMIRNATY administered to children age 5 to 11, we have shown that the third 10-microgram dose demonstrated a sixfold boost in utilizing wild-type SARS-CoV-2 and a 36-fold boost neutralizing the Omicron variant. Last week, we submitted an EUA request to the FDA for a third-dose boost in this population.

我們繼續為 COMIRNATY 尋求全面且數據驅動的臨床策略，專注於評估現實世界的疫苗有效性，通過增強劑證明更高的免疫原性，擴大對兒科人群的訪問並解決新出現的關注變體。在左側，在對 5 至 11 歲兒童進行 COMIRNATY 的 II/III 期試驗中，我們已經表明，第三次 10 微克劑量在利用野生型 SARS-CoV-2 方面表現出 6 倍的提升和 36 倍增強中和 Omicron 變體。上週，我們向 FDA 提交了一份 EUA 申請，要求在該人群中增加第三劑劑量。

On the right, we show that the third 30-microgram dose administered for adults in the landmark clinical trial effectively neutralized the Omicron sublineages, including BA.2 1 month after dose 3. We have also now received EUA for a second booster in people aged 50 and older and for individuals 12 years of age and older who have certain kinds of immunocompromise. This expanded authorization was based on data from Israel, generated while the Omicron variant was dominant, an approximately 11-fold increase in geometric mean neutralizing antibody titers against wild-type virus, Delta and Omicron variants, respectively, were reported at 2 weeks after the second booster as compared to 5 months after the first booster.

在右側，我們展示了在具有里程碑意義的臨床試驗中為成人施用的第三次 30 微克劑量有效地中和了 Omicron 亞系，包括在第 3 次劑量後 1 個月的 BA.2。我們現在還接受了 EUA，用於老年人的第二次加強50 歲及以上以及 12 歲及以上患有某些免疫功能低下的人。該擴展授權基於來自以色列的數據，在 Omicron 變體占主導地位時生成，在 2 週後報告的針對野生型病毒、Delta 和 Omicron 變體的幾何平均中和抗體滴度分別增加了約 11 倍第二次加強與第一次加強後 5 個月相比。

Here, we show recently published real-world data from Israel that the fourth dose of COMIRNATY lowered rates of hospitalization, severe illness and death amidst the Omicron outbreak. A fourth dose is now recommended for certain high-risk populations in more than 15 countries. There's been a notable increase in the number of pediatric infections and hospitalizations in the last few weeks. And we recognize that the parents of younger children and health care providers have been waiting for an effective vaccine. We have been working with urgency to generate data.

在這裡，我們展示了以色列最近公佈的真實數據，即第四劑 COMIRNATY 降低了 Omicron 爆發期間的住院率、重病率和死亡率。現在，超過 15 個國家/地區的某些高危人群建議使用第四劑。過去幾週，兒科感染和住院人數顯著增加。我們認識到，年幼兒童的父母和醫療保健提供者一直在等待有效的疫苗。我們一直在緊急工作以生成數據。

We began the rolling submissions for EUA in children aged 6 months to 4 years in February, while continuing to evaluate the third 3-microgram dose, which maybe optimal to deliver high degree of protection against Omicron. We expect to analyze and submit the 3-dose data by late May, early June and anticipate both FDA and CDC Advisory Committees to meet soon after to consider the submission.

我們在 2 月份開始滾動提交 6 個月至 4 歲兒童的 EUA，同時繼續評估第三個 3 微克劑量，這可能是對 Omicron 提供高度保護的最佳選擇。我們預計在 5 月下旬、6 月初之前分析和提交 3 劑數據，並預計 FDA 和 CDC 諮詢委員會將在不久後開會審議提交的內容。

Turning to PAXLOVID. Following EUA in December for both high-risk adults and high-risk children 12 and older weighing at least 40 kilograms, we expect to file soon and anticipate an FDA decision on the New Drug Application in these populations in the second half of '22. Recently, the WHO strongly recommended PAXLOVID for people with mild-to-moderate COVID-19 who are at the highest risk of hospitalization because they're unvaccinated, older or immunocompromised. We expect pivotal readouts of the standard risk study in the second half of '22 and reported top line results from the household contact prophylaxis study last week.

轉向 PAXLOVID。繼 12 月對高危成人和 12 歲及以上體重至少 40 公斤的高危兒童進行 EUA 之後，我們預計將很快提交並預計 FDA 將在 22 年下半年就這些人群的新藥申請做出決定。最近，世衛組織強烈建議將 PAXLOVID 用於因未接種疫苗、年齡較大或免疫功能低下而住院風險最高的輕度至中度 COVID-19 患者。我們預計 22 年下半年標準風險研究的關鍵讀數和上周家庭接觸預防研究報告的頂級結果。

In March, we initiated a study in children and expect to have data in the second quarter of '23. We are first enrolling children aged 6 to 17 years and working to develop an age-appropriate formulation for children younger than 6. A new study in immunocompromised patients is planned to start in the second half of '22. Some immunocompromised patients were enrolled in the EPIC-HR study. However, given the high unmet need, we believe (inaudible) will allow us to further evaluate PAXLOVID's efficacy in this population and ensure the treatment duration is optimized, given their more limited natural immune response to help clear infection.

3 月，我們啟動了一項針對兒童的研究，預計將在 23 年第二季度獲得數據。我們首先招募 6 至 17 歲的兒童，並努力為 6 歲以下的兒童開發適合年齡的配方。一項針對免疫功能低下患者的新研究計劃於 22 年下半年開始。一些免疫功能低下的患者參加了 EPIC-HR 研究。然而，鑑於未滿足的高需求，我們相信（聽不清）將使我們能夠進一步評估 PAXLOVID 在該人群中的療效並確保優化治療持續時間，因為它們更有限的自然免疫反應有助於清除感染。

With the close of the Arena acquisition in March, I'd like to highlight the potential for etrasimod as a best-in-class oral medicine for ulcerative colitis and its strategic fit within our overall inflammation and immunology pipeline. First, etrasimod is differentiated. It's a once-daily pill with rapid onset, no anticipated required titration and a promising benefit-risk profile. In the Phase III ELEVATE studies, etrasimod demonstrated robust clinical remission in patients with moderate-to-severe active ulcerative colitis. In March, we reported that the ELEVATE UC 52 trial met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints.

隨著 3 月份 Arena 收購的結束，我想強調 etrasimod 作為潰瘍性結腸炎的一流口服藥物的潛力，以及它在我們整體炎症和免疫學管道中的戰略契合。首先，etrasimod是有區別的。這是一種每日一次的藥丸，起效迅速，無需預期的滴定，並且具有良好的收益-風險特徵。在 III 期 ELEVATE 研究中，依曲莫德在中度至重度活動性潰瘍性結腸炎患者中表現出穩健的臨床緩解。 3 月，我們報導 ELEVATE UC 52 試驗在第 12 周和第 52 週均達到臨床緩解的共同主要終點以及所有關鍵次要終點。

Looking at the totality of data across Phase II and Phase III studies, we see a 12-week remission rate of 25% to 30% compared to placebo at 6% to 15%. We are projecting a filing in ulcerative colitis in the second half of '22. This candidate also has broad potential beyond UC. The adaptive Phase II/III study in Crohn's disease is ongoing, and we expect to start Phase III in atopic dermatitis in the fourth quarter. The potential expansion into Crohn's and eosinophilic esophagitis strengthen our gastroenterology pipeline. Overall, given that immuno-inflammatory diseases have heterogenous disease drivers which require multiple options for effective treatment and the continuing significant unmet need of patients in achieving long-term remission, we are excited about the portfolio of diverse and promising candidates from Arena that nicely complement our existing I&I pipeline.

縱觀 II 期和 III 期研究的全部數據，我們發現 12 週的緩解率為 25% 至 30%，而安慰劑為 6% 至 15%。我們計劃在 22 年下半年提交一份潰瘍性結腸炎的申請。這位候選人在加州大學之外也具有廣泛的潛力。克羅恩病的適應性 II/III 期研究正在進行中，我們預計將在第四季度開始針對特應性皮炎的 III 期研究。克羅恩病和嗜酸性食管炎的潛在擴張加強了我們的胃腸病學管道。總體而言，鑑於免疫炎症性疾病具有異源性疾病驅動因素，需要多種有效治療選擇，以及患者在實現長期緩解方面持續存在巨大未滿足的需求，我們對來自 Arena 的多樣化和有希望的候選藥物組合感到興奮，這些候選藥物很好地補充了我們現有的 I&I 管道。

Ritlecitinib is our unique cytokine modulator. It's a potent family inhibitor which spares IL-10 protective cytokines and spares dominant activity of existing effective oral agents. We have seen promising Phase II efficacy demonstrated across alopecia, vitiligo and ulcerative colitis. The Phase II study in Crohn's disease is ongoing. Ritlecitinib received FDA Breakthrough Designation for alopecia and we expect to file in the second quarter. We are finalizing potential Phase III study protocols for vitiligo and exploring paths for ulcerative colitis.

Ritlecitinib 是我們獨特的細胞因子調節劑。它是一種有效的家族抑製劑，可避免 IL-10 保護性細胞因子和現有有效口服藥物的主要活性。我們已經看到在脫髮、白癜風和潰瘍性結腸炎方面表現出有希望的 II 期療效。克羅恩病的 II 期研究正在進行中。 Ritlecitinib 獲得 FDA 對脫髮的突破性指定，我們預計將在第二季度提交。我們正在敲定潛在的白癜風 III 期研究方案，並探索潰瘍性結腸炎的路徑。

In Phase IIb, ritlecitinib demonstrated robust efficacy in both facial and total Vitiligo Area Severity Indexes, or VASI. Here, we showed a facial VASI improvement. On the left, ritlecitinib demonstrated up to 66% improvement from baseline through week 48. Efficacy was observed across light and dark skin types. On the right, you see 2 visual representations for significant improvement in facial VASI at 48 weeks.

在 IIb 期，ritlecitinib 在面部和總白癜風嚴重程度指數（VASI）中均表現出強大的療效。在這裡，我們展示了面部 VASI 的改善。在左側，從基線到第 48 週，ritlecitinib 表現出高達 66% 的改善。在淺色和深色皮膚類型中觀察到療效。在右側，您可以看到 48 週時面部 VASI 顯著改善的 2 個視覺表示。

Last month, we announced our intent to acquire ReViral and its respiratory syncytial virus therapeutic candidates. RSV remains a significant unmet need globally with no approved treatment, and the proposed acquisition will strengthen our capability in infectious disease R&D with a complementary strategy to help improve patient outcomes through treatment and prevent illness through vaccination. This mirrors our COVID-19 strategy, establishing leadership across vaccines and therapeutics for RSV to deliver potential breakthroughs.

上個月，我們宣布有意收購 ReViral 及其呼吸道合胞病毒治療候選藥物。在全球範圍內，RSV 仍然是一個未得到滿足的重大需求，沒有獲得批准的治療方法，擬議的收購將通過補充戰略加強我們在傳染病研發方面的能力，以幫助通過治療改善患者預後並通過疫苗接種預防疾病。這反映了我們的 COVID-19 戰略，在 RSV 的疫苗和療法方面建立了領導地位，以實現潛在的突破。

Our RSV candidate elicited high RSV A and B neutralizing titers in preclinical animal models and in Phase I/II clinical studies and has received FDA Breakthrough Designation for the maternal and adult programs. We anticipate total readouts of the maternal and adult studies in the second half of '22. ReViral's pipeline include a lead candidate, sisunatovir, which has received Fast Track Designation and the second program focused on the inhibition of RSV replication targeting the viral N protein.

我們的 RSV 候選者在臨床前動物模型和 I/II 期臨床研究中引發了高 RSV A 和 B 中和滴度，並已獲得 FDA 對母體和成人項目的突破性指定。我們預計在 22 年下半年母體和成人研究的總讀數。 ReViral 的產品線包括一個主要候選藥物 sisunatovir，它已獲得快速通道指定，第二個項目專注於抑製針對病毒 N 蛋白的 RSV 複製。

Sisunatovir is an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. In our Phase II health adult challenge study, sisunatovir significantly reduced viral load. The data are shown on the right. There's also an ongoing 3-part adaptive Phase II study in hospitalized infants. Successful completion of Part A was achieved in June '21 with favorable safety and pharmacokinetics. Part B is ongoing.

Sisunatovir 是一種口服抑製劑，旨在阻斷 RSV 病毒與宿主細胞的融合。在我們的 II 期健康成人挑戰研究中，西蘇那韋顯著降低了病毒載量。數據如右圖所示。還有一項正在進行的針對住院嬰兒的 3 部分適應性 II 期研究。 A 部分的成功完成於 21 年 6 月實現，具有良好的安全性和藥代動力學。 B 部分正在進行中。

We now turn to oncology and encouraging data on the Phase III trial of LORBRENA. 3-year follow-up data presented at AACR confirmed prolonged progression-free survival in first-line ALK-positive non-small cell lung cancer patients. There was a 73% reduction in risk of disease progression of test versus cristotinib. The 3-year PFS rate in the LORBRENA arm was 63.5%. 3-year rates for second-generation medicines are generally 20% points lower based on cross-trial assessment. No definitive conclusion can be drawn from cross-trial comparisons. There were no new safety signals and a low permanent discontinuation rate of 7.4% for patients on LORBRENA.

我們現在轉向腫瘤學和 LORBRENA III 期試驗的令人鼓舞的數據。 AACR 提交的 3 年隨訪數據證實，一線 ALK 陽性非小細胞肺癌患者的無進展生存期延長。與克里斯托替尼相比，測試的疾病進展風險降低了 73%。 LORBRENA 臂的 3 年 PFS 率為 63.5%。根據交叉試驗評估，第二代藥物的 3 年費率通常低 20%。從交叉試驗比較中無法得出明確的結論。 LORBRENA 患者沒有新的安全信號，永久停藥率低至 7.4%。

High central nervous system activity is important for patients with and without brain metastasis. Between 25% and 40% of ALK-positive patients present with brain metastasis at diagnosis. And between 24% and 40% of patients develop them within 2 years of diagnosis. Brain metastasis are one of the most common causes of death in this patient population. Leveraging our expertise in developing brain penetrant oncology treatments, LORBRENA was specifically designed to meet this significant unmet need.

高中樞神經系統活性對於有和沒有腦轉移的患者都很重要。 25% 至 40% 的 ALK 陽性患者在診斷時出現腦轉移。 24% 到 40% 的患者會在診斷後 2 年內患上這些疾病。腦轉移是該患者群體中最常見的死亡原因之一。利用我們在開發腦滲透性腫瘤治療方面的專業知識，LORBRENA 專為滿足這一未滿足的重大需求而設計。

We have seen high activity in patients with or without baseline brain metastasis. Significant intracranial activity was observed with LORBRENA as evidenced not only by intracranial response rates but also by time to intracranial progression as shown here. At 3 years of follow-up, 92.3% of patients treated with LORBRENA were alive and free of intracranial events compared with 37.7% treated with cristotinib. In LORBRENA-treated patients without brain metastasis, only 1 out of 112 patients had evidence of intracranial progression, suggesting a potential protective effect against development of brain metastasis with LORBRENA treatment.

我們已經看到有或沒有基線腦轉移的患者的高活性。用 LORBRENA 觀察到顯著的顱內活動，這不僅可以通過顱內反應率來證明，還可以通過此處顯示的顱內進展時間來證明。在 3 年的隨訪中，接受 LORBRENA 治療的患者中有 92.3% 存活且無顱內事件，而接受克羅替尼治療的患者為 37.7%。在 LORBRENA 治療的無腦轉移患者中，112 名患者中只有 1 名有顱內進展的證據，這表明 LORBRENA 治療對腦轉移的發展具有潛在的保護作用。

Here, we show the first data from the pediatric cohort of the Phase II trial of our Lyme disease vaccine candidate, the only one of its kind in clinical development. Lyme disease affects all age groups, but children are considered the population most at risk due to their outdoor activities. We saw robust immunicity across all pediatric age groups and serotypes and the safety profile was similar to that previously reported in adults. The program has received FDA Fast Track designation, and we plan to include pediatric participants in the Phase III trial expected to start in the third quarter. As in adults, the immunicity and safety data support a 3-dose primary vaccination schedule in pediatric participants in the Phase III study.

在這裡，我們展示了萊姆病候選疫苗 II 期試驗的兒科隊列的第一批數據，這是臨床開發中唯一的此類疫苗。萊姆病影響所有年齡組，但由於戶外活動，兒童被認為是最危險的人群。我們在所有兒科年齡組和血清型中都看到了強大的免疫性，並且安全性與之前在成人中報導的相似。該計劃已獲得 FDA 快速通道指定，我們計劃將兒科參與者納入預計將於第三季度開始的 III 期試驗。與成人一樣，免疫性和安全性數據支持 III 期研究中兒科參與者的 3 劑初級疫苗接種計劃。

Now I'd like to highlight our robust portfolio of investigational therapies to potentially treat all people with hemophilia. We expect a number of clinical trials for our hemophilia portfolio to read out in '23. Marstacimab is our novel nonfactor treatment candidate with the potential to address a broad patient population. As a new subcutaneous prophylactic treatment for patients with hemophilia A or B, including those with inhibitors, we anticipate the pivotal readout in second quarter '23. Marstacimab has FDA Fast Track designation for heme A and B patients with inhibitors. If successful, we predict submitting for the non-inhibitor indication in both heme A and B in the third quarter of '23.

現在，我想強調一下我們強大的研究療法組合，這些療法有可能治療所有血友病患者。我們預計我們的血友病產品組合的一些臨床試驗將在 23 年公佈。 Marstacimab 是我們的新型非因素治療候選藥物，具有解決廣泛患者群體的潛力。作為針對血友病 A 或 B 患者（包括使用抑製劑的患者）的一種新的皮下預防性治療，我們預計 23 年第二季度的關鍵讀數。 Marstacimab 具有 FDA 快速通道指定用於血紅素 A 和 B 患者的抑製劑。如果成功，我們預計在 23 年第三季度提交血紅素 A 和 B 中的非抑製劑適應症。

Turning to our gene therapy candidates. Last year, at ASH, we presented updated Phase Ib/II data from the largest cohort of persons with hemophilia B, who have had at least 3 years of follow-up with AAV gene therapy. 93% of participants achieved Factor IX activity in the mild or normal range between 3 to 5.5 years of follow-up. We expect a pivotal readout in the first quarter of '23. In heme A, we also presented updated Phase Ib data at ASH. Factor VIII activity was 25% of normal after 2 years in the highest dose cohort. The FDA has lifted a clinical hold on our Phase III pivotal study, and we anticipate study resumption in the third quarter of this year with a pivotal readout estimated in the second half of '23.

轉向我們的基因治療候選人。去年，在 ASH 上，我們提供了來自最大的血友病 B 患者隊列的更新的 Ib/II 期數據，這些人對 AAV 基因治療進行了至少 3 年的隨訪。在 3 至 5.5 年的隨訪期間，93% 的參與者在輕度或正常範圍內實現了因子 IX 活性。我們預計 23 年第一季度將出現關鍵讀數。在血紅素 A 中，我們還在 ASH 上展示了更新的 Ib 期數據。在最高劑量組中，因子 VIII 活性在 2 年後為正常值的 25%。 FDA 已經取消了對我們 III 期關鍵研究的臨床控制，我們預計今年第三季度將恢復研究，估計在 23 年下半年有一個關鍵讀數。

Finally, here are the top 25 key milestones achieved and anticipated for the rest of the year, 6 in the regulatory space, 12 pivot to readout and 7 early-stage readouts. I'd also note that last week, we announced the planned opening of the first U.S. sites in our Phase III trial evaluating our investigational mini-dystrophin gene therapy for ambulatory patients with Duchenne's muscular dystrophy. The trial also has received regulatory approvals to restart in several other countries. Pending regulatory feedback, we anticipate that nearly all sites will open by the end of June.

最後，以下是今年剩餘時間實現和預期的前 25 個關鍵里程碑，其中 6 個在監管領域，12 個轉向讀數和 7 個早期讀數。我還要指出，上週，我們宣布計劃在我們的 III 期試驗中開設第一個美國站點，以評估我們針對杜氏肌營養不良症患者的研究性微型肌營養不良蛋白基因療法。該試驗還獲得了監管部門的批准，可以在其他幾個國家重新開始。在等待監管反饋之前，我們預計幾乎所有站點都將在 6 月底之前開放。

In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use granted Prime Designation for GBS6, our maternal vaccine candidate against streptococcal infection. It's currently being evaluated in an ongoing Phase II study. Thank you for your attention and I look forward to your questions. Now let me turn it over to Frank.

此外，歐洲藥品管理局人用醫藥產品委員會授予 GBS6 的首要指定，這是我們針對鏈球菌感染的母體候選疫苗。目前正在一項正在進行的 II 期研究中對其進行評估。感謝您的關注，期待您的提問。現在讓我把它交給弗蘭克。

Thanks, Mikael. I know you've seen our release so let me provide a few brief highlights regarding the financials. Turning to the income statement. Revenue increased 82% operationally in the first quarter of 2022, driven by COVID-19 vaccine and PAXLOVID sales and strong performance for a number of our other key growth drivers. And looking at the revenue excluding the COVID-19 vaccine direct sales and alliance revenues and PAXLOVID contribution, it increased by 2% operationally. The effect of fewer selling days year-over-year decreased revenues by about 1%, and losses of exclusivity negatively impacted revenues by 2%. Operational growth would have been approximately 5% without these. Also, please remember that Q1 2021 grew 8% operationally, excluding COMIRNATY versus the prior year quarter, resulting in a very difficult comparable. This was broadly as expected and is embedded in our current guidance.

謝謝，米凱爾。我知道您已經看過我們的新聞稿，所以讓我簡要介紹一下財務方面的要點。轉向損益表。受 COVID-19 疫苗和 PAXLOVID 銷售以及我們其他一些關鍵增長動力的強勁表現的推動，2022 年第一季度的運營收入增長了 82%。從不包括 COVID-19疫苗直銷和聯盟收入以及 PAXLOVID 貢獻的收入來看，它的運營增長了 2%。銷售天數同比減少的影響使收入減少了約 1%，排他性的損失對收入產生了 2% 的負面影響。如果沒有這些，運營增長將約為 5%。此外，請記住，2021 年第一季度的運營增長了 8%，不包括 COMIRNATY 與去年同期相比，這導致了非常難以比較。這大致符合預期，並包含在我們當前的指導中。

The adjusted cost of sales increase shown here reduced this quarter's gross margin by approximately 10 percentage points as compared to the first quarter of 2021, with 14 percentage points attributable to the impact of higher COVID-19 vaccine sales year-over-year, partially mitigated by an unfavorable product mix for other products, primarily driven by higher sales of PAXLOVID and higher alliance revenues.

此處顯示的調整後銷售成本增加使本季度的毛利率與 2021 年第一季度相比降低了約 10 個百分點，其中 14 個百分點歸因於 COVID-19 疫苗銷售同比增加的影響，部分緩解了其他產品的不利產品組合，主要是由於 PAXLOVID 的銷售額增加和聯盟收入增加。

Adjusted SI&A expenses in the first quarter decreased primarily due to lower spending on corporate-enabling functions, partially offset by increased spending for COMIRNATY and PAXLOVID. The increase in adjusted R&D expense this quarter was primarily driven by increased investments in multiple late-stage clinical programs as well as additional spending on programs to prevent and treat COVID-19. The growth rate for reported diluted EPS was 59% while adjusted diluted EPS grew 76% operationally for the quarter. Foreign exchange movements resulted in a negative 5% impact to revenue as well as a negative 4% impact or $0.04 to adjusted diluted EPS.

第一季度調整後的 SI&A 費用下降主要是由於企業支持功能的支出減少，部分被 COMIRNATY 和 PAXLOVID 的支出增加所抵消。本季度調整後的研發費用增加的主要原因是對多個後期臨床項目的投資增加以及預防和治療 COVID-19 項目的額外支出。報告的攤薄每股收益增長率為 59%，而本季度調整後的攤薄每股收益在運營上增長了 76%。外匯變動對收入造成 5% 的負面影響，對調整後的攤薄每股收益造成 4% 的負面影響或 0.04 美元。

Now let's move to our updated 2022 guidance. We expect total company revenue to be in a range of $98 billion to $102 billion, representing an operational growth rate of 27% at the midpoint. The revenue range absorbs an additional $2 billion of anticipated negative impact from changes in foreign exchange rates as the U.S. dollar continued to strengthen against other currencies since we last updated our exchange rate assumptions.

現在讓我們轉到我們更新的 2022 年指南。我們預計公司總收入將在 980 億美元至 1020 億美元之間，中點運營增長率為 27%。自我們上次更新匯率假設以來，由於美元兌其他貨幣持續走強，收入範圍吸收了額外 20 億美元的預期負面影響。

Regarding our COVID-19-related revenues, we continue to expect the vaccine revenue for the year to be approximately $32 billion, unchanged compared to our prior guidance provided on February 8, despite the impact of $1 billion of incremental negative foreign exchange. For PAXLOVID, we expect sales of approximately $22 billion, keeping the guidance unchanged despite an incremental $500 million headwind due to foreign exchange. This means that excluding the COVID-19-related revenues, we expect sales to be approximately $46 billion at the midpoint, representing operational growth of 5% and absorbing the increased negative impact of about $500 million for foreign exchange. While this is slightly below the 6% CAGR that we continue to expect between 2020 and 2025, we continue to be confident in our ability to achieve that 2025 target.

關於我們與 COVID-19 相關的收入，我們繼續預計今年的疫苗收入約為 320 億美元，與我們在 2 月 8 日提供的先前指導相比保持不變，儘管增加了 10 億美元的負外匯影響。對於 PAXLOVID，我們預計銷售額約為 220 億美元，儘管由於外匯而增加了 5 億美元的逆風，但該指引保持不變。這意味著，不包括與 COVID-19 相關的收入，我們預計中點銷售額約為 460 億美元，運營增長 5%，並吸收了約 5 億美元的外匯負面影響。雖然這略低於我們繼續預期的 2020 年至 2025 年 6% 的複合年增長率，但我們仍然對實現 2025 年目標的能力充滿信心。

Now let me give some detail on our cost and expense guidance. We slightly improved our guidance for adjusted cost of sales, reducing the entire range by 20 basis points, the new range being 32% to 34%. We've separated the former R&D line into 2, R&D and a new line for acquired IP R&D to isolate the IP R&D charges, which are driven by business development transactions.

現在讓我詳細介紹一下我們的成本和費用指南。我們略微改進了對調整後銷售成本的指導，將整個範圍降低了 20 個基點，新範圍為 32% 至 34%。我們將原來的研發線分成了2條研發線和新的IP研發線，以隔離由業務開發交易驅動的IP研發費用。

Our guidance includes $900 million of this expense for 2022 based on business development transactions which have either already closed or are already signed as of mid-April, of which only $100 million was previously assumed and our R&D guidance for adjusted results. We will not forecast acquired R&D for transactions which are not closed (inaudible). We've also increased our adjusted R&D expense guidance by $500 million to reflect incremental life cycle spending for COVID-19 vaccines and antivirals and investments in other projects.

我們的指導包括 2022 年這筆費用中的 9 億美元，這些費用基於截至 4 月中旬已經完成或已經簽署的業務發展交易，其中之前僅假設了 1 億美元，以及我們對調整後結果的研髮指導。對於未完成的交易（聽不清），我們不會預測獲得的研發。我們還將調整後的研發費用指導增加了 5 億美元，以反映 COVID-19 疫苗和抗病毒藥物的生命週期支出增加以及對其他項目的投資。

In addition, as noted with fourth quarter results, we've made a decision to modify our adjusted results treatment of amortization of intangibles. Previously, we only excluded amortization related to large mergers and acquisitions, but we will now exclude all intangible asset amortization expense. This is anticipated to contribute $0.06 to our 2022 adjusted diluted earnings per share and improves comparability with our peers. This $0.06 was previously included in our 2022 guidance.

此外，正如第四季度業績所指出的，我們已決定修改我們對無形資產攤銷的調整後業績處理。以前，我們只排除了與大型併購相關的攤銷，但現在我們將排除所有無形資產的攤銷費用。預計這將為我們 2022 年調整後的攤薄每股收益貢獻 0.06 美元，並提高與同行的可比性。這 0.06 美元之前已包含在我們的 2022 年指導中。

These assumptions yield an adjusted diluted EPS range of $6.25 to $6.45 or 61% operational growth at the midpoint compared to 2021. This updated EPS guidance includes a $0.10 operational improvement, offset by a negative $0.11 due to foreign exchange and another $0.11 due to IP R&D. Together, these impacts led out to an adjusted EPS range, which is $0.10 lower than our initial guidance. 2022 guidance once again assumes no incremental share repurchases beyond the $2 billion of share repurchases we completed in March. Going forward, we will continue to be prudent in our capital allocation activities with the opportunities for deployment shown here on this slide.

與 2021 年相比，這些假設在中點產生了 6.25 美元至 6.45 美元的調整後稀釋每股收益範圍或 61% 的運營增長。更新後的每股收益指引包括 0.10 美元的運營改進，被外匯帶來的 0.11 美元的負數和知識產權研髮帶來的 0.11 美元抵消.這些影響共同導致調整後的每股收益範圍，比我們最初的指導低 0.10 美元。 2022 年指引再次假設，除了我們在 3 月份完成的 20 億美元股票回購之外，沒有增量股票回購。展望未來，我們將繼續謹慎地進行資本分配活動，並在本幻燈片中顯示部署機會。

So before I turn the call back to Chris to start the Q&A session, I wanted to make a personal comment. This conference call will mark my last as Pfizer's CFO, and I wish Dave and Pfizer all the success in the world. It has been my immense pleasure and privilege to serve as Pfizer's CFO for nearly 15 years. I've always enjoyed my interactions with you, our investors and our analysts and I will miss it. To my Pfizer colleagues, I am so proud of what we have accomplished together. I look forward to you achieving yet more success in the future. And as a large Pfizer shareholder, you can be sure that I'll be watching. With that, let me turn it over to Chris for Q&A.

因此，在我將電話轉回給 Chris 開始問答環節之前，我想發表個人評論。這次電話會議將標誌著我最後一次擔任輝瑞的首席財務官，我祝戴夫和輝瑞在世界上一切順利。擔任輝瑞 CFO 近 15 年，是我無比的榮幸和榮幸。我一直很享受與您、我們的投資者和分析師的互動，我會想念它的。對於我的輝瑞同事，我為我們共同取得的成就感到非常自豪。我期待你在未來取得更大的成功。作為輝瑞的大股東，你可以肯定我會關注。有了這個，讓我把它交給克里斯進行問答。

Thanks, Frank. With that, let's start the Q&A session. We will answer as many questions as time permits. And as always, Investor Relations will be available after the call to answer any questions you weren't able to ask. Operator, first question, please.

謝謝，弗蘭克。有了這個，讓我們開始問答環節。我們將在時間允許的情況下回答盡可能多的問題。與往常一樣，投資者關係部將在電話會議後回答您無法提出的任何問題。接線員，第一個問題，請。

Your first question comes from the line of Louise Chen with Cantor.

你的第一個問題來自於 Cantor 的 Louise Chen。

Frank, thank you for all your contributions to Pfizer, and we will really miss working with you. So first question I have for you is William, what are your initial impressions of Pfizer, having come recently from the outside? And then the second question I had is, what is the opportunity for a potential EU PAXLOVID contract and sales potential in China?

弗蘭克，感謝您為輝瑞所做的所有貢獻，我們將非常懷念與您的合作。所以我要問你的第一個問題是威廉，你對輝瑞的最初印像是什麼，最近來自外部？然後我的第二個問題是，在中國獲得潛在的歐盟 PAXLOVID 合同和銷售潛力的機會是什麼？

William, why don't you start with your impressions?

威廉，你為什麼不從你的印像開始？

Sure. Louise, thanks for the question. Yes, I would say I've been -- my expectations have been exceeded. Many reasons I came to Pfizer but one of them was the great science that's going on, the real dedication to breakthrough innovation but also the pace with which things have been done. And seeing Pfizer accomplish PAXLOVID and the vaccine were really inspiring, and I came to further build upon that and really transform how we do drug development.

當然。路易絲，謝謝你的問題。是的，我會說我已經——超出了我的期望。我來到輝瑞的原因有很多，但其中之一是正在進行的偉大科學、對突破性創新的真正奉獻以及完成工作的速度。看到輝瑞公司完成 PAXLOVID 和疫苗真的很鼓舞人心，我來進一步發展並真正改變我們進行藥物開發的方式。

Angela, you want to take a little bit the EU PAXLOVID contract?

安吉拉，你想拿一點歐盟的 PAXLOVID 合同嗎？

Yes. Thanks for the question, Louise. So in Europe, I would say that we're really taking a sort of a two-pronged approach to our contracting. One, we have bilateral agreements that have actually either been secured or about to be secured with many of our countries. But in addition to that, we're also looking at an EU-level contract. So I think more on that to come as we -- whenever we're ready to share what the outcome of that is, but just suffice to say that we're using both approaches in Europe.

是的。謝謝你的問題，路易絲。所以在歐洲，我想說的是，我們確實採取了一種雙管齊下的方式來處理我們的合同。第一，我們有雙邊協議，實際上已經或即將與我們的許多國家達成。但除此之外，我們還在研究歐盟層面的合同。因此，當我們準備好分享結果時，我會更多地考慮這一點，但只要說我們在歐洲使用這兩種方法就足夠了。

On China, what I am able to share is that we are working with a local distributor called Meheco to distribute and to ensure access to PAXLOVID in China. And that's what I'm able to say right now. I'm not really able to share more about the terms of the agreement or the volumes or anything related to that. So thanks.

在中國，我可以分享的是，我們正在與一家名為 Meheco 的當地分銷商合作，在中國分銷並確保 PAXLOVID 的訪問權。這就是我現在能說的。我真的無法分享更多關於協議條款或數量或與此相關的任何內容。那謝謝啦。

Your next question comes from the line of Evan Seigerman with BMO.

您的下一個問題來自 BMO 的 Evan Seigerman。

So I have 2 on COVID: one, when we think about the evolution of the booster market, how do you see this going? We've seen some data suggesting that we're kind of walking blindly into recommending boosters every so often. What's the ultimate goal of vaccination? Is it to prevent mild, symptomatic disease? Or is it really just to prevent the severe disease and overloading at the hospitals?

所以我有兩個關於 COVID：第一，當我們考慮助推器市場的演變時，您如何看待這種情況？我們已經看到一些數據表明我們經常盲目地推薦助推器。接種疫苗的最終目的是什麼？是為了預防輕微的、有症狀的疾病嗎？還是真的只是為了防止醫院的嚴重疾病和超載？

And then my second question is when we think about the evolution of the commercial model for PAXLOVID, can you talk to that? When do you expect to maybe file an NDA and transition away, at least in the United States, from kind of government contracting to more traditional commercial model?

然後我的第二個問題是，當我們考慮 PAXLOVID 商業模式的演變時，你能談談嗎？您預計何時提交 NDA 並過渡到（至少在美國）從政府承包到更傳統的商業模式？

Yes. Thank you for your questions. Let me see if I can answer and then I will ask our scientists if they have something to add. On the evolution of booster, I think all authorities, they are not moving blindly. We are moving based on data. And the reason why they recommend what they recommend is because data are supporting according to their opinion. I believe that right now, the effort it is to be able to stay ahead of the virus and the virus mutates and the most serious mutation that we have seen was the Omicron, one, because there was the one that was able to evade the new protection of us.

是的。謝謝你的提問。讓我看看我能不能回答，然後我會問我們的科學家是否有什麼要補充的。關於助推器的演變，我認為所有權威，他們都沒有盲目行動。我們正在根據數據移動。他們推薦他們推薦的東西的原因是因為數據根據他們的意見支持。我相信，現在，努力保持領先於病毒和病毒變異，我們見過的最嚴重的變異是 Omicron，一個，因為有一個能夠逃避新的保護我們。

Until then, I think the vaccines were offering very, very good protection against disease and, of course, an excellent protection against hospitalization and death. With Omicron, we saw that while we keep a very good protection against hospitalization and deaths, the protection against the disease is going down. So we have seen that with our data that a fourth dose of the current vaccine protects significantly folds, many folds, the patients from either hospitalizations or death and, of course, also protects the infections but not to the degree that it used to be.

在那之前，我認為疫苗提供了非常非常好的預防疾病的保護，當然，還可以很好地預防住院和死亡。通過 Omicron，我們看到雖然我們對住院和死亡保持了很好的保護，但對疾病的保護卻在下降。因此，我們已經看到，根據我們的數據，當前疫苗的第四劑可以顯著保護患者免於住院或死亡，當然，也可以保護感染，但程度不及以前。

Everybody is working also for new vaccines that will be able to protect better against Omicron while maintaining the same protection against the wild types. We are very advanced with our studies. And we are waiting to hear from FDA what basic combinations they would recommend, what they would like to see at the EMA, and we will be ready day 1 with our vaccines, both in terms of filing and both in terms of manufacturing. As regards PAXLOVID, right now, we are completing the studies and I will ask Mikael to comment when we think that we can file for a full NDA.

每個人都在努力開發新的疫苗，這些疫苗能夠更好地保護 Omicron，同時保持對野生類型的相同保護。我們的學習非常先進。我們正在等待 FDA 的消息，他們會推薦哪些基本組合，他們希望在 EMA 看到什麼，我們將在第一天準備好我們的疫苗，無論是在申請方面還是在製造方面。至於 PAXLOVID，目前我們正在完成研究，當我們認為可以申請完整的 NDA 時，我會請 Mikael 發表評論。

Yes. We will file NDA quite soon, this half of the year, and look forward to, as soon as possible, pending review, getting it approved, which would allow even more engagement with the medical and other communities. So we think that would be very helpful in order to increase education and access to the medicine.

是的。我們將在今年上半年很快提交 NDA，並期待盡快等待審查並獲得批准，這將允許與醫療和其他社區進行更多的接觸。因此，我們認為這將非常有助於增加教育和獲得藥物的機會。

And anything to add on the booster and how we are looking at it?

還有什麼可以添加到助推器以及我們如何看待它？

You described very well how this has been science-driven, and Pfizer is proud to have been leading, often the first, for whether it is primary series, a boost or new age group. So I just wanted to add that we expect, pending (inaudible) start the fall season with a vaccination campaign, a new boost, which will be critical then to regain, and as Albert alluded to, possibly further strengthen versus new evolution that we're seeing in Omicron. And it's likely going to be an annual procedure with this type of public recommendation about strains.

你很好地描述了這是如何由科學驅動的，輝瑞很自豪能夠在主要係列、助推或新年齡組方面一直處於領先地位，而且往往是第一。因此，我只想補充一點，我們預計，在秋季開始之前（聽不清）疫苗接種運動，新的推動力，這將是關鍵，然後重新獲得，正如阿爾伯特所暗示的那樣，可能會進一步加強與我們的新進化。重新在 Omicron 看到。這很可能會成為每年一次的程序，並提供這種關於菌株的公開推薦。

And for some more vulnerable patient groups, immunocompromised, older, we have learned that it may be even in between an extra dose. So we are on top of the science, and we expect every year to be able to incorporate new science. We're doing multiple learnings on how to further evolve the vaccine and see us as a natural leader as we have established such deep insights.

對於一些更脆弱、免疫功能低下、年齡較大的患者群體，我們了解到它甚至可能介於額外劑量之間。所以我們處於科學的前沿，我們希望每年都能融入新的科學。我們正在就如何進一步發展疫苗進行多次學習，並將我們視為天生的領導者，因為我們已經建立瞭如此深刻的見解。

William, anything to add?

威廉，有什麼要補充的嗎？

No.

不。

Your next question comes from the line of Mohit Bansal with Wells Fargo.

您的下一個問題來自富國銀行的 Mohit Bansal。

Maybe 1 question regarding PAXLOVID. So it seems like you have mentioned 6 million courses with sales is about $1.5 billion. So discount rates are about $250 per course price. So am I calculating it right? And number two, it seems like you're suggesting that all 20 million courses in 2Q would be shipped. So is that correct, and the pricing should be lower or higher than $250 per course?

可能有 1 個關於 PAXLOVID 的問題。因此，您似乎提到了 600 萬門課程，銷售額約為 15 億美元。因此，每門課程價格的折扣率約為 250 美元。那我計算對了嗎？第二，您似乎是在暗示第二季度所有 2000 萬門課程都將發貨。那是正確的嗎？定價應該低於或高於每門課程 250 美元？

Thank you very much, Mohit. No, there is a disconnect. Let me try to explain it. We did produce 6 million doses in -- by the end of March. From them, only 4.2 million or 4.3 million were shipped outside in March. The remaining were shipped in the first week of February basically. But also from the 4.2 million that were shipped, the very small proportion -- a smaller proportion was recorded as revenues in this quarter. Why? Because most of them were shipped in March, and everything that were shipped in the U.S. in March accounts for Q1, but everything that were shipped internationally in Q1 counts for Q2 in the accounting calendar that we have.

非常感謝你，莫希特。不，有斷線。讓我試著解釋一下。到 3 月底，我們確實生產了 600 萬劑。從他們那裡，3 月份只有 420 萬或 430 萬件被運往國外。其餘的基本上在二月的第一周發貨。但在出貨的 420 萬台中，也只有很小的一部分——較小的一部分被記錄為本季度的收入。為什麼？因為它們中的大多數都是在 3 月份發貨的，而 3 月份在美國發貨的所有東西都計入第一季度，但在我們擁有的會計日曆中，第一季度國際發貨的所有東西都計入第二季度。

So the doses that are made, this $1.5 billion of sales, is way smaller than the 6 million doses that you referred. In terms of what we expect, we expect in this quarter to have 24 million doses, so by the end of June, to have been able to produce 30 million doses altogether. Clearly, some of that again will be shipped in July. Clearly, some of that will be shipped in June in international markets. So you should not be calculating as it have in the first quarter, that everything will go into, let's say, the second quarter of all this volume.

因此，所生產的劑量，即 15 億美元的銷售額，遠小於您提到的 600 萬劑。就我們的預期而言，我們預計本季度將生產 2400 萬劑，因此到 6 月底，總共能夠生產 3000 萬劑。顯然，其中一些將在 7 月再次發貨。顯然，其中一些將在 6 月在國際市場上發貨。所以你不應該像第一季度那樣計算一切都將進入，比如說，所有這些交易量的第二季度。

Your next question comes from the line of Terence Flynn with Morgan Stanley.

您的下一個問題來自摩根士丹利的 Terence Flynn。

I know it's a little too early to give 2023 guidance, but maybe Angela or Frank, could you just help us think about the puts and takes for COMIRNATY for next year, and if you think consensus is in the right range at $17 billion to $18 billion. And then my second question relates to etrasimod for ulcerative colitis. Mikael, based on your comments, it seems like the placebo response rate in the Phase III trial might have been slightly higher than Phase II. Just wondering if that's accurate and any additional insight you could share there.

我知道現在給出 2023 年的指導還為時過早，但也許安吉拉或弗蘭克，你能不能幫我們考慮一下明年 COMIRNATY 的看跌期權，如果你認為共識在 170 億美元到 18 美元的正確範圍內十億。然後我的第二個問題與潰瘍性結腸炎的依曲莫德有關。 Mikael，根據您的評論，III 期試驗中的安慰劑反應率可能略高於 II 期。只是想知道這是否準確以及您可以在那里分享的任何其他見解。

Thanks so much, Terence. Look, I will ask Frank, but good luck, he will not give you guidance for a product and she will not give you guidance for '23. But let's see how he responds to that question. And then Mikael, can you speak about etrasimod?

非常感謝，特倫斯。聽著，我會問弗蘭克，但祝你好運，他不會為您提供產品指導，她也不會為您提供 23 年的指導。但讓我們看看他是如何回答這個問題的。然後是 Mikael，你能談談 etrasimod 嗎？

So I'm not going to provide 2023 guidance. But obviously, what we did for 2022 guidance, we reiterated the guidance on PAXLOVID. We reiterated the guidance on COMIRNATY. By the way, $54 billion approximately of revenue while absorbing $1.5 billion of foreign exchange. And if you listened to the commentary we've had so far on PAXLOVID, we remain bullish on PAXLOVID if you look at some of the recent trends and you look at some of the charts that Albert provided in terms of tenfold growth from the end of February to mid of April, the number of sites that we're at, 33,000 sites now. So the rhythm of that product looks very good and we remain very bullish.

所以我不會提供 2023 年的指導。但顯然，我們為 2022 年的指導所做的工作，我們重申了對 PAXLOVID 的指導。我們重申了關於 COMIRNATY 的指導。順便說一句，大約 540 億美元的收入同時吸收了 15 億美元的外匯。如果您聽取了我們迄今為止對 PAXLOVID 的評論，如果您查看最近的一些趨勢並查看 Albert 提供的一些圖表，我們仍然看好 PAXLOVID。 2 月到 4 月中旬，我們所在的站點數量，現在有 33,000 個站點。所以該產品的節奏看起來非常好，我們仍然非常看好。

And those I will say that for 2023, there are going to be a lot of puts and takes because there will be likely new innovation that is coming that we need to see how that plays and also changes in the business models, right? There is a chance that the U.S. will go to private market in the next year. I think likely international, they will continue with governmental purchases, and we do have a contract for these purchases that goes '23 and beyond at '24. So there are a lot of puts and takes that will be in play here. But let's move to something that is very interesting, etrasimod.

我要說的是，到 2023 年，將會有很多投入和投入，因為可能會有新的創新出現，我們需要看看它是如何發揮作用的，以及商業模式的變化，對吧？明年美國有可能進入私人市場。我認為可能是國際性的，他們將繼續進行政府採購，我們確實有一份在 23 年及 24 年以後的採購合同。所以這裡有很多看跌期權。但是讓我們轉向一個非常有趣的東西，etrasimod。

Yes. Thank you for your interest, Terence, there. And I think, of course, the I shared was based on the pivotal studies that will be filed. And noted that one of them did have a placebo rate slightly higher. The more extensive of the Phase III had a traditional placebo rate and a very nice delta between treated and untreated. As you know, for great drugs, you would like to see in the range of maybe a 20% delta. And while we won't give you all details as we're expecting data soon to be presented this year at the proper conference, I can assure you that we saw a very nice favorable delta for etrasimod treated.

是的。謝謝你的興趣，特倫斯。我認為，當然，我分享的內容是基於將要提交的關鍵研究。並指出其中一個人的安慰劑率確實略高。更廣泛的第三階段具有傳統的安慰劑率和治療和未治療之間的非常好的增量。如您所知，對於偉大的藥物，您希望看到可能有 20% 的增量。雖然我們不會向您提供所有詳細信息，因為我們預計數據很快會在今年的適當會議上公佈，但我可以向您保證，我們看到了對 etrasimod 治療的非常有利的 delta。

We talked about 12-week remission rate in our earnings talking point. The drug did very well in the 52-week maintenance phase and all secondary endpoints are looking very favorable. So that's really why we think it can be both best-in-class and, in some way, a best-in-disease, given its convenience, its rapid onset of action, its well-tolerated profile.

我們在收益談話要點中談到了 12 週的緩解率。該藥物在 52 週的維持期表現非常好，所有次要終點看起來都非常有利。所以這就是為什麼我們認為它既可以是同類最佳，又可以在某種程度上是疾病中的最佳，因為它方便、起效快、耐受性好。

Your next question comes from the line of Vamil Divan with Mizuho.

您的下一個問題來自 Vamil Divan 與 Mizuho 的對話。

Maybe just shifting gears a little bit to the quarter and some of the core products here. So what I'm curious about Ibrance, especially in the U.S. because we -- I know you mentioned again in the release it was down 5% and some of this was through the Patient Assistance Program. And I guess I assume I thought that was more of a 2021 dynamic kind of going through the pandemic. And by this year, it may actually be more of a positive pricing benefit that you see. So maybe you can just kind of share a little bit more color on what you're seeing in the market there.

也許只是稍微改變一下這個季度和這裡的一些核心產品。所以我對 Ibrance 感到好奇，尤其是在美國，因為我們——我知道你在新聞稿中再次提到它下降了 5%，其中一些是通過患者援助計劃實現的。而且我想我認為我認為這更像是 2021 年經歷大流行的動態類型。到今年，你看到的實際上可能更多的是積極的定價優勢。所以，也許你可以就你在市場上看到的東西分享更多的色彩。

And then the second 1 is on Xeljanz, which is obviously down quite a bit. We don't know what the safety issues and label updates and all that. I'm just trying to get a better sense of how you see that product sort of going forward. You obviously have a good immunology pipeline and a lot of other assets to leverage here, but do you see sort of Xeljanz stabilizing here? Do you (inaudible)? So how would you sort of view that price outlook over the rest of the year and in the next year or 2 going forward?

然後第二個 1 在 Xeljanz 上，顯然下降了很多。我們不知道安全問題和標籤更新等等。我只是想更好地了解您如何看待該產品的發展方向。你顯然有一個很好的免疫學管道和許多其他資產可以在這裡利用，但你看到 Xeljanz 在這裡穩定了嗎？你（聽不清）嗎？那麼，您如何看待今年剩餘時間以及未來一兩年的價格前景？

Thank you, Vamil. Very good questions, both of them. So Angela, start with Ibrance and then you go to Xeljanz.

謝謝你，瓦米爾。非常好的問題，他們兩個。所以安吉拉，從 Ibrance 開始，然後你去 Xeljanz。

Sure thing. So let's talk about Ibrance first. Just from a performance perspective, I just want to emphasize that Ibrance is still, by far and away, the undisputed leader in the CDK class. Actually, in ex U.S., it grew 12% this quarter. And as you mentioned accurately, it did have a negative 5% growth in the U.S., and this was largely due to the PAP. In fact, if you strip that out, TRx volume actually grew 3% in the U.S. for Ibrance. So it's really this high proportion of unpaid RXs that led us to this revenue growth that you saw.

肯定的事。所以讓我們先談談Ibrance。僅從性能的角度來看，我只想強調 Ibrance 仍然是 CDK 類無可爭議的領導者。實際上，在美國以外的地區，本季度增長了 12%。正如你準確提到的，它在美國確實有 5% 的負增長，這主要是由於人民行動黨。事實上，如果將其剔除，Ibrance 在美國的 TRx 交易量實際上增長了 3%。因此，正是如此高比例的未付費 RX 導致我們實現了您所看到的收入增長。

Just to give you a sense of the scale of the PAP, compared to a year ago, we have seen a 32% increase in PAP applications. And however, Q1 was similar to where we were in Q4 in terms of the number of enrollees. But maybe if we step back, it may be not so surprising that Ibrance would have such a high proportion of PAP because it is the market leader. More than 75% of all the scripts in the CDK class belong to a part of Ibrance. And so if you link that to the financial hardships that are still in the economy, and you link that to the fact that there are reduced alternate sourcing of financial assistance, which is driving more people to the Ibrance PAP.

只是為了讓您了解 PAP 的規模，與一年前相比，我們看到 PAP 申請增加了 32%。然而，就註冊人數而言，第一季度與第四季度相似。但也許如果我們退後一步，Ibrance 擁有如此高比例的 PAP 可能並不令人驚訝，因為它是市場領導者。 CDK 類中超過 75% 的腳本屬於 Ibrance 的一部分。因此，如果您將其與經濟中仍然存在的財務困難聯繫起來，並且您將其與替代性財務援助來源減少的事實聯繫起來，這將促使更多人加入 Ibrance PAP。

Also, just from an annual perspective, patients enrolled in January, most of them and that they stay for the year, so I think what we're seeing is approximately what we're going to continue to see for the remainder of the year. But maybe the important message here is that this does not mean that there is no growth opportunity for Ibrance even in 2022. We know that there is tremendous growth opportunity in the CDK class. And our ability to make this pie bigger is going to be great for patients as well.

此外，僅從年度的角度來看，1 月份入組的患者中的大多數人都待了一年，所以我認為我們所看到的大約是我們將在今年餘下時間繼續看到的情況。但也許這裡的重要信息是，這並不意味著即使在 2022 年 Ibrance 也沒有增長機會。我們知道 CDK 類有巨大的增長機會。我們做大這個餡餅的能力對患者也很有好處。

We saw, just in the last year, an increase of the CDK class from where we were in Q1 of 2021, which was just 48% to where we are now, this quarter in '22, which is 54%. So this positive momentum of the growth of the class is something that we are very focused on, in addition to the fact that, of course, over the pandemic, we did see some lag in new patient starts and new diagnosis of metastatic breast cancer patients or delays in putting them on treatment. And so that's another area of focus for us as well that will help to drive the increased momentum around Ibrance. So that's Ibrance.

就在去年，我們看到 CDK 課程從 2021 年第一季度的 48% 增加到 22 年本季度的 54%。因此，這種班級增長的積極勢頭是我們非常關注的事情，此外，當然，在大流行期間，我們確實看到新患者開始和轉移性乳腺癌患者的新診斷出現了一些滯後或延誤他們接受治療。因此，這也是我們關注的另一個領域，這將有助於推動 Ibrance 周圍的增長勢頭。這就是 Ibrance。

So let's spend a minute talking about Xeljanz and your question around sort of where are we with Xeljanz and what do we see. And we definitely see 2022 as a year of transition for us. Why? Well, first, when you step back and look at Xeljanz performance, you have to look beyond Xeljanz. It's not just about the product, it's also about the class. And so just to give you some numbers on what has happened in the class, over the last year, so between this quarter and same quarter last year in 2021, the new-to-brand prescriptions in the JAK class actually went down 40%.

因此，讓我們花一點時間談談 Xeljanz 和您的問題，即我們在哪裡使用 Xeljanz 以及我們看到了什麼。我們絕對將 2022 年視為我們過渡的一年。為什麼？好吧，首先，當您退後一步看 Xeljanz 的性能時，您必須超越 Xeljanz。這不僅與產品有關，還與課程有關。所以只是為了給你一些關於過去一年課堂上發生的事情的數字，所以在 2021 年這個季度和去年同一季度之間，JAK 類的新品牌處方實際上下降了 40%。

Now Xeljanz went down 50% but we also saw products like of the product in the JAK class go down by 35%. So when we look at growth, it's important that the class returns to growth as well. I'd say that '22 is going to be a year of transition for Xeljanz because we finally have a clear label. And with this label, we're going to be able to focus on the post-TNF segment as our place and it's the place where Xeljanz can play. And this market is also significant because we know that many patients don't respond to TNFs and most will need options beyond TNFs.

現在 Xeljanz 下降了 50%，但我們也看到像 JAK 類產品這樣的產品下降了 35%。因此，當我們關注增長時，重要的是班級也恢復增長。我會說 22 年將是 Xeljanz 過渡的一年，因為我們終於有了一個明確的標籤。有了這個標籤，我們將能夠專注於後 TNF 部分，這是我們的位置，也是 Xeljanz 可以發揮的地方。這個市場也很重要，因為我們知道許多患者對 TNF 沒有反應，而且大多數患者需要 TNF 以外的選擇。

Finally, we're seeing some nice signs of stabilization compared to where we were over the last year. For the first time, our new-to-brand Rxs are stable versus declining. We're also seeing that there are switches back into Xeljanz versus just purely away from Xeljanz. In our market research, we see an increase in the intention to prescribe by health care professionals. And then finally, also in the market research, we see that the safety perceptions of Xeljanz are equivalent to that of So it demonstrates the playing field in the JAK class is now leveling. So we're really focused on education. We have massive education efforts behind Xeljanz to reestablish where and how Xeljanz should be used, and that's what gives us confidence that we can return Xeljanz to growth.

最後，與去年相比，我們看到了一些不錯的穩定跡象。第一次，我們的新品牌 Rxs 穩定而不是下降。我們還看到有切換回 Xeljanz 而不是完全遠離 Xeljanz。在我們的市場研究中，我們看到醫療保健專業人員開具處方的意願有所增加。最後，同樣在市場研究中，我們看到 Xeljanz 的安全感知與安全感知相當，因此它表明 JAK 類的競爭環境現在正在平衡。所以我們真的專注於教育。我們在 Xeljanz 背後進行了大量的教育工作，以重新確定應該在何處以及如何使用 Xeljanz，這讓我們有信心讓 Xeljanz 恢復增長。

Thank you, Angela. As always, a very comprehensive answer.

謝謝你，安吉拉。一如既往，一個非常全面的答案。

Your next question comes from the line of Kerry Holford with Berenberg.

您的下一個問題來自 Kerry Holford 和 Berenberg 的觀點。

A couple of questions, please. Firstly, on COVID vaccine. I noted in your 10-K that you expect to recognize at least $11.8 billion of revenues in 2023. Should we think about that as a floor for next year based on the contracts you've already signed? And if so, have you signed any further contracts for delivery in 2023 and beyond since you published that 10-K in February? .

有幾個問題，請。首先，關於COVID疫苗。我在您的 10-K 中指出，您預計 2023 年將確認至少 118 億美元的收入。根據您已經簽署的合同，我們是否應該將其視為明年的底線？如果是這樣，自您在 2 月發布 10-K 以來，您是否簽署了任何進一步的 2023 年及以後交付合同？ .

Secondly, on the RSV vaccine, I saw in Slide 36 you're now confirming the Phase III data readout for (inaudible) vaccine now in the second half of the year. Does that totally reflect the expansion of the patient population was in the study? Do you need to run into another RSV season? Or are you also evaluating annual RSV vaccinations in this study? And lastly, when do you aim to file and launch that product in the U.S.?

其次，關於 RSV 疫苗，我在幻燈片 36 中看到您現在正在確認今年下半年（聽不清）疫苗的 III 期數據讀數。這是否完全反映了研究中患者人數的增加？您是否需要進入另一個 RSV 季節？或者您是否也在本研究中評估年度 RSV 疫苗接種？最後，您打算什麼時候在美國提交和推出該產品？

Thank you very much. Frank, do you want to give the answer on the...

非常感謝你。弗蘭克，你想給出關於...的答案嗎？

Yes. Just in terms of 2023, we'll talk about 2023 in detail when we provide 2023 guidance, which will be on our fourth quarter earnings call. We'll talk about the puts and takes. We'll explain where we are this year, where we are next year, what the growth drivers are. And obviously, that will include what the revenues will be for the COVID vaccine. So that's to come.

是的。僅就 2023 年而言，我們將在提供 2023 年指導時詳細討論 2023 年，這將在我們的第四季度財報電話會議上。我們將討論看跌期權。我們將解釋今年我們在哪裡，明年我們在哪裡，增長動力是什麼。顯然，這將包括 COVID 疫苗的收入。所以就這樣了。

And then Mikael, do you want to take the RSV question about the seasonal filing, and then William, if you have anything to add, please?

然後是 Mikael，你想回答關於季節性申報的 RSV 問題嗎，然後是 William，如果你有什麼要補充的，好嗎？

Yes. As I spoke in the introduction, Pfizer is very excited about the portfolio of the RSV vaccine and the RSV therapeutics. And I think we have had very strong data in the Phase II CHALLENGE study, complete protection and also in the MATERNAL study where we actually, with small numbers, had 85% efficacy and very strong immunicity across the A and B strains. I believe we are the only 1 with such a comprehensive data set.

是的。正如我在介紹中所說，輝瑞對 RSV 疫苗和 RSV 療法的產品組合感到非常興奮。而且我認為我們在 II 期 CHALLENGE 研究中獲得了非常強大的數據，完全保護以及在 MATERNAL 研究中，我們實際上在 A 和 B 菌株中具有 85% 的療效和非常強的免疫性。我相信我們是唯一擁有如此全面數據集的公司。

Starting with the MATERNAL, to the best of my knowledge, we are really the only advanced RSV vaccine there. We took the opportunity as we had sites opening up in Latin America to also capture from that region of the world and in this now, 2022 season, more cases to add to our study. And we expect in a couple to a few months to have the readout based on (inaudible) for the MATERNAL. And relatively shorter thereafter this year, the adult trial is expected based on a comprehensive set of sites also in the Southern Hemisphere. So it's really a perfect composition of RSV cases from different parts of the world. And I look forward very much to the readouts and remain very optimistic. It's one of my favorite programs.

從 MATERNAL 開始，據我所知，我們確實是那裡唯一的先進 RSV 疫苗。我們抓住了這個機會，因為我們在拉丁美洲開設了網站，也從世界該地區捕獲了更多的案例，在現在的 2022 年季節，我們的研究中增加了更多案例。我們預計在幾個月到幾個月內會根據（聽不清）對 MATERNAL 進行讀數。今年之後的時間相對較短，預計成人試驗將基於南半球的一組綜合地點。因此，它確實是來自世界不同地區的 RSV 病例的完美組合。我非常期待讀數並保持非常樂觀。這是我最喜歡的節目之一。

Mine as well. William, anything to add?

我的也是。威廉，有什麼要補充的嗎？

Yes. I would just add that you mentioned already, Mikael, that both programs got Breakthrough Designation. And so we're very excited about that.

是的。我只想補充一點，你已經提到過，Mikael，這兩個程序都獲得了突破性稱號。所以我們對此感到非常興奮。

Of course, everybody recognize that it's apparent the (inaudible).

當然，每個人都承認這很明顯（聽不清）。

Your next question comes from the line of Steve Scala with Cowen.

您的下一個問題來自 Steve Scala 與 Cowen 的對話。

And thank you, Frank, for everything, and all the best to you in the future. I have a follow-up on the RSV vaccine. In which ACIP meeting in 2023 would the Pfizer vaccine most likely be considered? And I assume, of course, you have not seen premature birth in the maternal study, but do you have a theory as to why you haven't when your competitor has? And then a question on Eliquis for Angela. To what degree has bleeding risk limited prescribing of Eliquis? And if a drug came along that was associated with less bleeding, do you think that would be a significantly preferred agent?

謝謝你，弗蘭克，感謝你所做的一切，祝你未來一切順利。我對 RSV 疫苗進行了跟進。輝瑞疫苗最有可能在 2023 年的哪個 ACIP 會議上被考慮？當然，我假設你沒有在孕產婦研究中看到過早產，但是你有一個理論來解釋為什麼你沒有看到你的競爭對手有嗎？然後是安吉拉關於 Eliquis 的問題。出血風險在多大程度上限制了 Eliquis 的處方？如果出現了一種與較少出血相關的藥物，你認為這會是一個明顯首選的藥物嗎？

All right. Angela, why don't you take the ACIP meeting and then also the question about the bleeding and then we can go to Mikael?

好的。安吉拉，你為什麼不參加 ACIP 會議以及關於出血的問題，然後我們可以去找 Mikael？

Sure. ACIP, the schedule for ACIP is just closely held by the ACIP, the working group and the CDC. So it's a really difficult thing for me to be able to predict. But typically, it's sort of within the 2- to 3-month period of -- from launch, right, because you know that it only happens several times of the year. So you really need to be able to catch it right to be able to meet whatever their next meeting is. So I honestly think that's a very difficult question to answer. But suffice to say that, of course, we will work as rapidly as possible to ensure that it gets on the schedule of the very next 1 post launch.

當然。 ACIP，ACIP 的時間表只是由 ACIP、工作組和 CDC 密切掌握。所以我很難預測。但通常情況下，它在 2 到 3 個月內——從發布開始，對，因為你知道它一年中只發生幾次。所以你真的需要能夠抓住它，以便能夠滿足他們的下一次會議。所以老實說，我認為這是一個很難回答的問題。但我只想說，當然，我們將盡快工作，以確保它在下一個發布後的時間表上得到滿足。

On your question around bleeding, it has not been 1 that has come up actually for Eliquis, in large measure, I have to say. Our performance continues to be really strong. We're the #1 NOAC in 24 markets. We're the #1 oral anticoagulant in 21 other markets. So I'd say that the uptake of Eliquis outperformance, which as you can see this quarter, continues to be double digit, I think it's the tenth year in a row that we've had double-digit growth on Eliquis. And we continue to see tremendous market share and utilization. So I would say that, that has not been an issue that we have seen.

關於你關於出血的問題，我不得不說，在很大程度上，Eliquis 實際上並沒有出現 1。我們的表現仍然非常強勁。我們是 24 個市場中排名第一的 NOAC。我們是其他 21 個市場中排名第一的口服抗凝劑。所以我想說的是，正如你在本季度所看到的那樣，Eliquis 的表現仍然是兩位數，我認為這是我們連續第十年在 Eliquis 上實現兩位數的增長。我們繼續看到巨大的市場份額和利用率。所以我會說，這不是我們看到的問題。

Frank?

坦率？

And if I could just punctuate, if you look at the revenue number this quarter for Eliquis, the revenue number is $1.8 billion almost, up 12% operationally. Continued, continued strong performance by that product.

如果我能打斷一下，如果你看看 Eliquis 本季度的收入數字，收入數字幾乎是 18 億美元，運營增長了 12%。該產品的持續、持續強勁表現。

Exactly, exactly. And also, I wanted also to add to Angela's comment, of course, we can't predict when ACIP will do whatever they think is appropriate to do. But we do know that RSV is considered by CDC as a major disease threat. And I'm sure that, as always, they will demonstrate the appropriate urgency to deal with a vaccine if it is registered. Mikael, there was this question about premature births that we do not have, and if you can provide some why we don't and why others may.

正是，正是。而且，我還想補充一下 Angela 的評論，當然，我們無法預測 ACIP 何時會做他們認為合適的任何事情。但我們確實知道，CDC 認為 RSV 是一種主要的疾病威脅。我相信，如果疫苗已註冊，他們將一如既往地表現出處理疫苗的適當緊迫性。 Mikael，有一個關於早產的問題，我們沒有，如果你能提供一些為什麼我們沒有，為什麼其他人可能。

Well, we have a very deep and long experience how to design vaccines and for different patient groups. As this is for maternal, we obviously developed a very well-tolerated vaccine, and we were able, without the need of any harsh adjuvants, to get very high immune responses, that included that we use both RSV A and B antigens. I believe we're the only 1 that have that going.

好吧，我們在如何設計疫苗和針對不同的患者群體方面有著非常深刻和長期的經驗。由於這是針對母體的，我們顯然開發了一種耐受性非常好的疫苗，我們能夠在不需要任何刺激性佐劑的情況下獲得非常高的免疫反應，包括我們同時使用 RSV A 和 B 抗原。我相信我們是唯一能做到這一點的人。

I can't really be certain on the other vaccine you're referring to, but certainly, it's not an advantage to use an adjuvant that was known to give very significant local and systemic adjuvant actions for a fragile patient group like maternal. So we feel very bullish that we are the main vaccine in the maternal. We'd only that have a bivalent model, strong data behind it and look very much forward to the readout.

我不能確定您所指的另一種疫苗，但可以肯定的是，使用已知可以為母親等脆弱患者群體提供非常顯著的局部和全身佐劑作用的佐劑並不是一個優勢。所以我們非常看好我們是孕產婦的主要疫苗。我們只會有一個二價模型，背後有強大的數據，並且非常期待讀數。

Your next question comes from the line of Colin Bristow with UBS.

您的下一個問題來自瑞銀的 Colin Bristow。

And I wanted to say all the best to Frank. So a couple on my side. On the business development front, could you comment on how large a deal you would be willing to consider? And is there a preference for marketed assets or pipeline or some combination of the 2? And then just in terms of disease spaces, yes, I'd be curious to hear how you view the rare disease category as an area of potential business development from here.

我想對弗蘭克說最好的。所以我身邊有一對。在業務發展方面，您能評論一下您願意考慮多大的交易嗎？是否對已上市資產或管道或兩者的某種組合有偏好？然後就疾病領域而言，是的，我很想知道您如何從這裡將罕見病類別視為潛在業務發展的領域。

And then just a quick 1 on PAXLOVID. I understand your prior comments, but I just want to get a sense here on what is the risk that we end '22, and obviously, the doses have been purchased but are essentially stockpiled or not utilized, which could subsequently impact '23 onwards.

然後只是一個關於 PAXLOVID 的快速 1。我理解你之前的評論，但我只是想在這裡了解一下我們結束 22 年的風險是什麼，顯然，這些劑量已經購買但基本上是儲存或未使用，這可能會影響到 23 年以後。

Thank you very much. Why don't we start with the BD questions and I will ask Aamir Malik to speak about it?

非常感謝你。我們為什麼不從 BD 問題開始，我會請 Aamir Malik 談談它？

Colin, thanks for your question. On our BD focus, I think we've been very clear that compounds that have the potential to be breakthroughs is where our focus is. And these can be in the form of late-stage clinical development, they can be in earlier medical innovations as well as, as well as early launches. We're going to bias to the TAs where we have scientific and commercial expertise because we can add value. We're going to be flexible on deal structures.

科林，謝謝你的提問。關於我們的 BD 重點，我認為我們已經非常清楚，具有突破潛力的化合物是我們的重點所在。這些可以是後期臨床開發的形式，也可以是早期的醫學創新，也可以是早期的推出。我們將偏向於我們擁有科學和商業專業知識的 TA，因為我們可以增加價值。我們將在交易結構上保持靈活。

And on your question on size, we've been very clear in the past that we're agnostic to size. But we're not going to focus on deals where cost synergies are the primary source of value creation. We're going to focus on deals where we can add value, we have a scope to have impact and where there's going to be revenue impact in the '25 to '30 time period. So that is our current focus.

關於你關於尺寸的問題，我們過去一直非常清楚，我們對尺寸是不可知的。但我們不會專注於成本協同效應是價值創造主要來源的交易。我們將專注於可以增加價值的交易，我們有一定的影響範圍，以及在 25 到 30 年期間會對收入產生影響的交易。這就是我們目前的重點。

Thank you very much, Aamir. And as we said also multiple times, it is important to see Pfizer as a partner of choice also. So it is important to see Pfizer as the company that can add value, either by acquiring or by partnering molecules, with companies to the same extent that we have proven with other biotechs that we can provide benefits to patients by putting our capabilities into work. And that's, I think, it is the way moving forward.

非常感謝，阿米爾。正如我們多次所說，將輝瑞視為首選合作夥伴也很重要。因此，重要的是要將輝瑞視為一家可以通過收購或通過與公司合作來增加價值的公司，就像我們與其他生物技術公司證明的那樣，我們可以通過將我們的能力付諸實踐來為患者帶來好處。我認為，這就是前進的方向。

And clearly, we are focusing on filling the gap between '25 and '30. We started this call again by making -- myself making comments that we reiterate that we plan to have $25 billion of risk-adjusted revenues with analyst expectations by the year 2030. And we feel that we are moving as per plan to achieve that goal. Now let me turn to Angela to speak a little bit about PAXLOVID and the question about is there any risk that the quantities will be purchased will not be utilized.

顯然，我們正專注於填補 25 年和 30 年之間的空白。我們再次開始這個電話，我本人發表評論，我們重申我們計劃到 2030 年根據分析師的預期獲得 250 億美元的風險調整收入。我們認為我們正在按計劃實現這一目標。現在讓我請安吉拉談談 PAXLOVID，問題是是否存在購買的數量不會被利用的風險。

So I think when we think about our contracts and what has been purchased, we also think a lot about demand, right, like generating demand and utilizing the product. And I think that the U.S. gives us a good example of what you can see when utilization and adoption picks up. You heard from Albert's opening presentation that just in the last few weeks, we saw the prescriptions of PAXLOVID grow 10x. And just in 1 week alone, you've got as high as 80,000 prescriptions that were dispensed.

所以我認為當我們考慮我們的合同和購買的東西時，我們也會考慮很多需求，對，比如產生需求和利用產品。我認為美國為我們提供了一個很好的例子，說明當利用率和採用率上升時你可以看到什麼。您從 Albert 的開幕演講中聽說，就在過去幾週，我們看到 PAXLOVID 的處方增長了 10 倍。僅在 1 週內，您就獲得了高達 80,000 份處方。

You also heard that there are 30,000 sites that are available now in the U.S. that dispensed PAXLOVID and that is increasing. Deep dive to those Test to Treat sites, which were only 1,100 at the beginning of April and now have doubled to 2,000. And you add upon that, the U.S. government's announcements around their focus on increasing more sites. All of this is showing us that momentum around PAXLOVID is real and that there are a few sort of key levers that open up this access. One is the number of sites and the proximity to patients. And two, it's the education around how to use PAXLOVID and who are the patients that are eligible.

您還聽說美國現在有 30,000 個站點提供 PAXLOVID，而且還在增加。深入了解那些 Test to Treat 站點，這些站點在 4 月初只有 1,100 個，現在已經翻了一番，達到 2,000 個。你補充說，美國政府圍繞他們的重點是增加更多網站的公告。所有這些都向我們表明，圍繞 PAXLOVID 的勢頭是真實的，並且有幾種關鍵槓桿可以打開這種訪問權限。一是站點的數量和與患者的接近程度。第二，這是關於如何使用 PAXLOVID 以及誰是符合條件的患者的教育。

And so when you think about what has happened in the U.S., you now are beginning to see that happen around the world as well. We see that demand is increasing. You heard Albert speak about how countries that have purchased from us are now coming back with reorders. You're also seeing in, across many countries, how they are changing their eligibility for criteria for PAXLOVID as well as the number of sites where PAXLOVID can be accessed, much like what we're seeing here in the U.S.

因此，當您考慮在美國發生的事情時，您現在開始看到世界各地也發生了這種情況。我們看到需求正在增加。您聽到 Albert 談到從我們這裡購買的國家現在如何重新訂購。您還可以看到，在許多國家/地區，他們正在如何改變他們對 PAXLOVID 標準的資格以及可以訪問 PAXLOVID 的網站數量，就像我們在美國看到的一樣。

So I think when you add all of this up, what we are seeing is the fact that there is demand for this product. We also see that the social -- the removal of the mask mandate, the social distancing requirements that have been removed. You also know that in the EU that just in the last week, they've removed the emergency period of the EUA. That means that people are going to get out there. We know with all of that, infections are going to increase, and that's the role that PAXLOVID can play.

所以我認為當你把所有這些加起來時，我們看到的是對這個產品有需求的事實。我們還看到社會——取消面具的要求，已經取消的社會距離要求。你也知道在歐盟，就在上週，他們已經取消了 EUA 的緊急時期。這意味著人們將走出去。我們知道所有這些，感染將會增加，這就是 PAXLOVID 可以發揮的作用。

So we're intently focused on working with national governments, state governments, in helping them to educate, to take great lessons learned from around all the different countries to help them to utilize PAXLOVID. And importantly, what we're also seeing is that it's not as -- we don't have any inventory on hand. Every dose that we produce is being shipped out and is being ordered. So I think all of these give us a lot of confidence that there is a demand for PAXLOVID. We know what we need to do to support the utilization of PAXLOVID, and we'll continue to drive that throughout the year as we anticipate further surges in COVID infections.

因此，我們專注於與國家政府、州政府合作，幫助他們進行教育，從所有不同國家吸取豐富的經驗教訓，幫助他們利用 PAXLOVID。重要的是，我們還看到它不是 - 我們手頭沒有任何庫存。我們生產的每一劑都被運出並被訂購。所以我認為所有這些都讓我們對 PAXLOVID 的需求充滿信心。我們知道我們需要做些什麼來支持 PAXLOVID 的使用，我們將在全年繼續推動這一點，因為我們預計 COVID 感染會進一步激增。

Thank you, Angela. And also what Angela said, I want to reiterate that I like what we have seen with the partners of vaccines that the governments were trying because of lack of manufacturing capacity to build stocks. Right now, the orders that we are coming are orders not for the entire year. They are orders for the immediate needs of the countries. And this is why we have repeated orders of COVID. That's across many all countries that we see internationally.

謝謝你，安吉拉。還有安吉拉所說的，我想重申，我喜歡我們看到的疫苗合作夥伴，因為政府缺乏生產能力來建立庫存。現在，我們來的訂單不是全年的訂單。它們是針對各國迫切需要的命令。這就是我們重複訂購 COVID 的原因。我們在國際上看到的許多國家都是如此。

Your next question comes from the line of Carter Gould with Barclays.

您的下一個問題來自於 Barclays 的 Carter Gould。

Best of luck to post-Pfizer endeavors, and I appreciate all the color on PAXLOVID right there. Maybe moving to the pipeline. In highlighting your UC franchise in the slides, you focused on etrasimod (inaudible) notably didn't mention your TL1A program. Has your enthusiasm there shifted now that you have the induction data in-house? And on the IRAK4 side, I saw the discontinuation in HS. Has that changed in any way how we should think about development in RA? I believe that got removed from your early-stage readout calendar?

祝輝瑞後的努力好運，我很欣賞 PAXLOVID 上的所有顏色。也許轉移到管道。在幻燈片中突出您的 UC 特許經營權時，您專注於 etrasimod（聽不清），特別是沒有提及您的 TL1A 計劃。既然您擁有內部的感應數據，您的熱情是否已經轉移？在 IRAK4 方面，我看到了 HS 的停產。這是否以任何方式改變了我們應該如何看待 RA 的發展？我相信這已經從您的早期讀出日曆中刪除了？

Thank you very much, Carter. Mikael, the floor is yours.

非常感謝你，卡特。 Mikael，地板是你的。

Yes. I did speak about that etrasimod creates a very rounded and comprehensive pipeline. I think the TL1A data that we have in our hands, and it will be -- I shared earlier at previous earnings calls, some of it, it's very strong. Actually, to the best of my knowledge, in the biomarker selected group, it's probably the strongest or among the very strong that I have seen.

是的。我確實談到了 etrasimod 創建了一個非常全面和全面的管道。我認為我們手中掌握的 TL1A 數據，它將是 - 我早些時候在之前的財報電話會議上分享過，其中一些非常強大。實際上，據我所知，在生物標誌物選擇組中，它可能是我見過的最強或非常強的組。

I think it can be a very much complementary drug to etrasimod. And we also know that the TL1A principle, not just as anti-inflammatory but also play a role in fibrosis. We didn't have much time to speak about ritlecitinib beyond our real exciting data that we shared in vitiligo. We also have additional inflammatory drugs that are coming to readouts with strong data behind them for potential start of pivotal, such as interferon beta in inflammatory muscle diseases.

我認為它可以成為依曲莫德的一種非常互補的藥物。而且我們也知道TL1A的原理，不僅起到抗炎作用，還起到纖維化的作用。除了我們在白癜風中分享的真正令人興奮的數據之外，我們沒有太多時間談論 ritlecitinib。我們還有其他炎症藥物即將發布，這些藥物背後有強大的數據，可能是關鍵的開始，例如炎症性肌肉疾病中的干擾素β。

So I would just say we have the advantage of a richness now of inflammatory drugs and really building a pipeline with complementary approaches. And we hope to share more which of the ones that will be kicked off soonest from the many options that we now have in our hands, but TL1A clearly a very active drug.

所以我只想說，我們現在擁有豐富的炎症藥物的優勢，並真正建立了一條具有互補方法的管道。我們希望更多地分享我們現在擁有的眾多選擇中哪些將最快啟動，但 TL1A 顯然是一種非常活躍的藥物。

Your next question comes from the line of Andrew Baum with Citi.

您的下一個問題來自花旗銀行的 Andrew Baum。

A couple of questions, please. Firstly, Pfizer is the leader in cardiology thrombosis and hemostasis. Four of your competitors have Factor XIa inhibitors in clinical development. There's still significant unmet needs in thrombosis despite the NOACs. I'm curious as to why you've passed on the opportunity and what data would make you change your mind or review your decision.

有幾個問題，請。首先，輝瑞是心髒病學血栓和止血領域的領導者。您的四個競爭對手在臨床開發中擁有因子 XIa 抑製劑。儘管使用了 NOAC，但血栓形成方面的需求仍未得到滿足。我很好奇你為什麼放棄這個機會，哪些數據會讓你改變主意或重新審視你的決定。

And then the second question is going back to the barriers that PAXLOVID adoption that have existed historically. You've addressed, addressing the access barriers. But in terms of physician education and holding back prescribing because of supply, patient awareness, how would you delineate the percentage contribution of those to the current underutilization of PAXLOVID? And what do you think are the time lines for knocking down the separate reasons?

然後第二個問題是回到過去一直存在的採用 PAXLOVID 的障礙。您已經解決了訪問障礙。但就醫生教育和因供應、患者意識而推遲開處方而言，您如何描述這些對當前 PAXLOVID 未充分利用的貢獻百分比？您認為消除單獨原因的時間線是什麼？

Mikael, why don't you take the cardiology question?

Mikael，你為什麼不回答心髒病學的問題？

Yes. First of all, we think the breakthrough with Eliquis, the NOACs, was so dramatic for patients and physicians from warfarin, which had many issues of significance, including a very complicated dosing and risk for bleeding. While we monitor new drug classes, including the 1 that you have mentioned, we really want to see a similar step-up in breakthrough potential as we saw with Eliquis. And we haven't yet been convinced about that step-up, but we are carefully monitoring. And internal medicine and cardiometabolic diseases is an area that we think are very interesting. And you, of course, heard us speak about oral GLP-1 as another very important growth area.

是的。首先，我們認為 Eliquis 的突破，即 NOAC，對於華法林的患者和醫生來說是如此引人注目，這有許多重要的問題，包括非常複雜的劑量和出血風險。雖然我們監測新藥類別，包括您提到的 1 類，但我們真的希望看到與 Eliquis 類似的突破潛力提升。我們還沒有確信這一升級，但我們正在仔細監控。內科和心臟代謝疾病是我們認為非常有趣的一個領域。當然，您也聽說過我們談到口服 GLP-1 是另一個非常重要的增長領域。

Thank you, Mikael. And then Angela, what about the education that we plan to do alone or with governments to address other barriers of (inaudible) available or other stuff that Andrew spoke about?

謝謝你，米凱爾。然後安吉拉，我們計劃單獨或與政府合作以解決其他可用的（聽不清）障礙或安德魯談到的其他問題的教育呢？

Well, education is key, an it underpins the promotion of all of our products. But I think the first comment I have to make is that you all know, we're under an EUA. And in this EUA, we're really -- we are limited by what we are allowed to talk about and also limited by the level of promotion that we would typically do. And that's why you see that much of the education that is occurring right now is coming from the government, whether that's the CDC or at the state level, state departments of health and how they've chosen to roll out the messages regarding antiviral treatments.

嗯，教育是關鍵，它是我們所有產品推廣的基礎。但我認為我必鬚髮表的第一條評論是，你們都知道，我們處於 EUA 之下。在這個 EUA 中，我們真的 - 我們受到允許談論的內容的限制，也受到我們通常會做的促銷水平的限制。這就是為什麼你看到現在正在進行的大部分教育都來自政府，無論是疾病預防控制中心還是州一級，州衛生部門以及他們如何選擇推出有關抗病毒治療的信息。

Of course, we're supplementing that by what we can do. We've put public service announcements out there. We've utilized our field force in the appropriate way to convey, when we're able to, through an EUA. And there is just a significant amount of medical education as well that we are doing, again, also in an EUA-appropriate way to support our brand. But of course, this doesn't look anything like what we would typically do if we had a full commercial launch where we would have the ability to really deploy the entirety of our promotional engine towards education and towards support of both patients and physicians. So I would say that the education is happening and we are doing our part, and I think that there is a lot more that can be done.

當然，我們正在通過我們可以做的事情來補充它。我們已經發布了公共服務公告。當我們能夠通過 EUA 時，我們以適當的方式利用我們的現場力量來傳達信息。而且，我們正在做大量的醫學教育，同樣，也是以適合 EUA 的方式來支持我們的品牌。但是，當然，這看起來不像我們通常會做的事情，如果我們有一個完整的商業發布，我們將有能力真正部署我們的整個促銷引擎以用於教育和支持患者和醫生。所以我想說教育正在發生，我們正在儘自己的一份力量，我認為還有很多事情可以做。

But I think the second part of your question was also around how much does this contribute to the bigger issue. And I want to say that truly, the ability to access product quickly is one, that even though there's been great improvements, I think that there's still a long way to go. Even with all the improvements that we have had recently, we're still a fraction, I would say, under half of all the possible retail locations where PAXLOVID could be found. So it's tremendous that we're seeing this uplift, but I would say that we need to continue on the path of where we've been and continue to do more because there's still a lot more that can be done.

但我認為你問題的第二部分也是關於這對更大的問題有多大貢獻。我想說的是，快速訪問產品的能力是其中之一，即使有很大的改進，我認為還有很長的路要走。即使我們最近進行了所有改進，但我想說，在可以找到 PAXLOVID 的所有可能零售地點中，我們仍然只是一小部分。因此，我們看到這種提升是巨大的，但我要說的是，我們需要繼續走上我們曾經走過的道路，並繼續做更多的事情，因為還有很多事情可以做。

Thank you, Angela. And of course, I wanted also to add that I have also never seen the government being so active. They truly believe that it is a way to control hospitalizations and deaths. And we see that their own educational campaigns are working because as we have seen, there is a tenfold increase just in a few weeks, and I think that comes together with all the measures that they are taking, I think will yield even more impressive results. I'm confident.

謝謝你，安吉拉。當然，我還想補充一點，我也從未見過政府如此活躍。他們真的相信這是控制住院和死亡的一種方式。我們看到他們自己的教育活動正在發揮作用，因為正如我們所看到的，僅僅在幾週內就增加了十倍，我認為這與他們正在採取的所有措施相結合，我認為會產生更令人印象深刻的結果.我很自信。

Your next question comes from the line of Chris Schott with JPMorgan.

您的下一個問題來自摩根大通的 Chris Schott。

Just 2 additional PAXLOVID ones. I think it was a question of kind of contracting. It seems like we saw a lot of activity late last year, early this year. But it's been a bit more quiet, I guess, more recently on the contracting front. So I know you're expecting more contracts for PAXLOVID, but just qualitatively, can you just give us a sense of how broad of a swath of the market has already entered in contracts, they're going to satisfy demand this year relative to how large a portion of, I guess, a realistic global market are still in negotiations and still need to come up to some agreements? I'm just trying a sense of like what does the TAM look like versus what's been contracted.

只有 2 個額外的 PAXLOVID。我認為這是一個合同類型的問題。去年年底，今年年初，我們似乎看到了很多活動。但我想，最近在合同方面，它有點安靜。所以我知道你期待更多的 PAXLOVID 合同，但就質量而言，你能否讓我們了解一下已經簽訂合同的市場範圍有多大，相對於今年的需求如何我猜，一個現實的全球市場的很大一部分仍在談判中，還需要達成一些協議嗎？我只是想了解一下 TAM 的外觀與合同的外觀。

And then my second, just 1 on PAXLOVID was there seems like there's been several data points of kind of PAXLOVID like kind of COVID rebound occurring in some patients. Is that something you're seeing in your data? And just how are you thinking about kind of addressing that as we kind of learn more about the longer-term outcomes in some patients there?

然後我的第二個，在 PAXLOVID 上只有 1 個，似乎有幾個類似 PAXLOVID 的數據點，例如在某些患者中發生的 COVID 反彈。這是您在數據中看到的嗎？當我們更多地了解那裡一些患者的長期結果時，你是如何考慮解決這個問題的？

Thank you very much, Chris. Excellent questions. Angela, what about our contracting?

非常感謝你，克里斯。優秀的問題。安吉拉，我們的合同呢？

Well, I would have to say that I'm really pleased with how our contracting has gone. You heard Albert talk about the 100 countries that we are engaging with. And actually, compared to where we were last quarter, we've made some really nice and significant progress. In terms of the number of countries, just to give you a sense, we've actually -- when we think about the $22 billion in guidance, right, plus the $500 million that we're absorbing from foreign exchange, when you think about that part of revenue, it really consists of countries that we have finalized contracts with as well as countries that we anticipate to close shortly. So there are sort of 2 buckets of countries in there.

好吧，我不得不說我對我們的合同進行得非常滿意。你聽過 Albert 談到我們正在參與的 100 個國家。實際上，與上一季度相比，我們已經取得了一些非常好的和顯著的進步。就國家的數量而言，讓你感覺一下，我們實際上 - 當我們考慮 220 億美元的指導時，對，加上我們從外匯中吸收的 5 億美元，當你考慮時這部分收入，實際上包括我們已與之敲定合同的國家以及我們預計將很快關閉的國家。所以那裡有2個國家。

And what I'm happy to say is that compared to where we were in the first quarter, we are 3x larger in terms of the number of countries that have actually finalized contracts. So that's the first thing. But in addition to that, we have bilaterals that have either been completed or about to be completed with 60 countries, and that doesn't count the multilateral agreements that we're also having. You heard about UNICEF earlier today from Albert. We have others as well in the works. So I think when you think about the total addressable market, as you say, I think that we are not done, but we have combed through a large proportion of them, and that gives me great confidence in our ability to meet the guidance that we've provided you.

我很高興地說，與第一季度相比，我們實際完成合同的國家數量增加了 3 倍。所以這是第一件事。但除此之外，我們與 60 個國家的雙邊協議已經完成或即將完成，這還不包括我們也擁有的多邊協議。你今天早些時候從阿爾伯特那裡聽說了聯合國兒童基金會。我們還有其他人正在開發中。所以我認為當你考慮到整個潛在市場時，正如你所說，我認為我們還沒有完成，但我們已經梳理了其中很大一部分，這讓我對我們有能力滿足我們的指導充滿信心已經提供給你了。

And also, I want to reemphasize that what is different with PAXLOVID contracts is that we signed a contract with -- typically they start with smaller volumes and then they keep ordering and reordering. It's very important to have the legal framework so that a country can order first, which we have done, but they are ordering based on the needs rather than based on the anticipation to build stocks, which that also, by itself, shows that with the signed contract you expect more because it's not to cover the whole year. But of course, all will depend on the usage in the field. We're optimistic, but we need to see how the usage in the field will go. William, you want to take the COVID rebound?

而且，我想再次強調 PAXLOVID 合同的不同之處在於我們與他們簽訂了合同——通常他們從較小的數量開始，然後他們繼續訂購和重新訂購。擁有法律框架非常重要，這樣一個國家就可以首先訂購，我們已經這樣做了，但他們是根據需求而不是基於建立庫存的預期來訂購的，這本身也表明，隨著簽訂的合同您期望更高，因為它不會涵蓋全年。但當然，一切都取決於該領域的使用情況。我們很樂觀，但我們需要看看該領域的使用情況如何。威廉，你想接受 COVID 反彈嗎？

Sure. So we take very seriously the case reports that have been anecdotal so far in terms of potential rebound and (inaudible) PAXLOVID. To respond to that, we've taken some preliminary look at our EPIC high-risk data. And so we've seen, for example, that we -- about an incidence about 2% of that viral load rebound. But we also see the same or close to the same percent in the placebo arm. So it's something that's not particularly associated with PAXLOVID but may have something to do with the virus itself.

當然。因此，我們非常重視迄今為止在潛在反彈和（聽不清）PAXLOVID 方面的軼事案例報告。為了對此做出回應，我們對 EPIC 高風險數據進行了初步研究。因此，我們已經看到，例如，我們 - 大約 2% 的病毒載量反彈的發生率。但我們也看到安慰劑組的百分比相同或接近相同。因此，它與 PAXLOVID 沒有特別關聯，但可能與病毒本身有關。

We've also looked for patient characteristics and potential recurrence of severe symptoms, and we haven't seen any association with patient characteristics or severe symptoms developing in these patients who rebound. And then finally, we haven't seen any association with mutations in Mpro, which is the target of PAXLOVID. So it's preliminary data so far. We again take it very seriously, but it's occurring at a very low incidence. And we continue to learn as we go along.

我們還尋找了患者特徵和嚴重症狀的潛在復發，我們沒有發現這些反彈患者與患者特徵或嚴重症狀有任何關聯。最後，我們還沒有看到與 Mpro 中的突變有任何關聯，這是 PAXLOVID 的目標。所以這是目前的初步數據。我們再次非常重視它，但它的發生率非常低。我們繼續學習。

Mikael, any (inaudible)

Mikael，任何（聽不清）

It was a very good response from Will. So I'll just add as we do surveillance of patients in very large databases, and we have access to more than 300,000 PAXLOVID treated. In one of the databases, we have reports of this happening in less -- in about 0.005% or less, which is less than 1 out of 3,000 treated patients. So overall, it's quite uncommon. But as Will spoke about, it's not really related to PAXLOVID but more to the individuals that then need to clear the virus. And it is a virus that can either reinfect patients or that can be reservoirs left in the patients.

這是威爾的一個很好的回應。因此，我將在我們對非常大的數據庫中的患者進行監測時添加，我們可以訪問超過 300,000 名接受治療的 PAXLOVID。在其中一個數據庫中，我們有報告稱這種情況發生的機率較低——大約 0.005% 或更少，即不到 3,000 名接受治療的患者中的 1 人。所以總的來說，這很不常見。但正如威爾所說，它與 PAXLOVID 並沒有真正的關係，而更多的是與需要清除病毒的個人有關。它是一種病毒，可以重新感染患者，也可以成為患者體內的宿主。

Now what we also learned is that for some patients, immunocompromised, they may carry this virus for a very, very long time. And we see that area as a real new opportunity growth area for PAXLOVID to do very well, where you may need to take multiple courses over a year or even treat with extended duration, and that's something we're now planning to study in order to expand the use of PAXLOVID where it may be the most appropriate and life-saving drug.

現在我們還了解到，對於一些免疫功能低下的患者，他們可能會在很長一段時間內攜帶這種病毒。我們認為該領域是 PAXLOVID 做得非常好的一個真正的新機會增長領域，您可能需要在一年內參加多門課程，甚至延長治療時間，這就是我們現在計劃研究的內容，以便擴大 PAXLOVID 的使用範圍，因為它可能是最合適和最能挽救生命的藥物。

And as Mikael said, the work of PAXLOVID is to reduce the viral load and, as a result, help your body overcome the disease faster and without serious consequences. It could be that in some cases, there is a rebound. That was why the label speaks about a second treatment that can be given. And also we need to think that if by reducing, and it seems in all these cases that have reported that actually did what they're supposed to do, which is reduce the virus load because they became negative.

正如 Mikael 所說，PAXLOVID 的工作是減少病毒載量，從而幫助您的身體更快地克服疾病，而不會造成嚴重後果。在某些情況下，可能會出現反彈。這就是為什麼標籤上提到可以進行第二次治療的原因。我們還需要考慮，如果通過減少，似乎在所有這些報告的案例中，他們確實做了他們應該做的事情，那就是減少病毒載量，因為它們變成了陰性。

So then they came back. I can only imagine if without the help of PAXLOVID, what will be the clinical symptoms of the patients that is coming back. So let's not forget that this is for people that they already sick and we help them go easy with their disease, easier than without PAXLOVID. And so far it's working extremely well.

於是他們回來了。我只能想像如果沒有 PAXLOVID 的幫助，回來的患者會有什麼臨床症狀。所以我們不要忘記，這適用於他們已經生病的人，我們幫助他們輕鬆應對疾病，比沒有 PAXLOVID 更容易。到目前為止，它運行得非常好。

Your next question comes from the line of Tim Anderson with Wolfe Research.

您的下一個問題來自沃爾夫研究公司的蒂姆·安德森（Tim Anderson）。

I have a couple of questions. Prevnar 20 in pediatrics, important franchise, (inaudible) 75% of current usage. It looks like the readout of your peds trials has slipped from first half to second half. I'm wondering if you can explain why and if that impacts your confidence in the readout at all. Second question, your biosimilars are growing. Your press release mentions interchangeable HUMIRA. We have no real precedent with Part D biosimilars in the U.S. My view has been that AbbVie is going to hold on to more share than what they've been guiding for. But as you're on the other side of this, I'd love to get your perspective. I know your launch is a year away, but what are your expectations for uptake in the U.S. for biosimilar HUMIRA, whether it's yours or anyone else's? And how do you think that will compare to what we've seen with biosimilars with Part D drugs like Avastin?

我有一些問題。 Prevnar 20 在兒科，重要的特許經營權，（聽不清）當前使用量的 75%。看起來您的 peds 試驗讀數從上半場滑到了下半場。我想知道您是否可以解釋原因以及這是否會影響您對讀數的信心。第二個問題，你們的生物仿製藥正在增長。您的新聞稿提到了可互換的 HUMIRA。在美國，我們在 D 部分生物仿製藥方面沒有真正的先例。我的觀點是，艾伯維（AbbVie）將保持比他們一直在指導的更多的份額。但是，由於您站在另一邊，我很想了解您的觀點。我知道您的上市還有一年的時間，但是您對生物仿製藥 HUMIRA 在美國的使用有何期望，無論是您的還是其他人的？您認為這與我們在生物仿製藥中看到的與阿瓦斯汀等 D 部分藥物相比如何？

Thank you. Mikael, Prevnar 20?

謝謝你。米凱爾，Prevnar 20？

Yes. It's a very minor shift. We're predicting earlier, mid of the year and we now see it will come in the second half. Not too far away from our original prediction is what I believe and it was just affected by COVID and (inaudible) which we could get infants vaccinated. So overall, it's on track for readout. We had a very good readout with adult. I have no reason to believe that we won't have also a very good performance in the clinical trial for the pediatric.

是的。這是一個非常小的轉變。我們在今年年中早些時候預測，現在我們看到它會在下半年到來。我相信與我們最初的預測相距不遠，它只是受到 COVID 的影響，並且（聽不清）我們可以讓嬰兒接種疫苗。因此，總體而言，它的讀數正在走上正軌。我們與成人的讀數非常好。我沒有理由相信我們在兒科臨床試驗中也不會有很好的表現。

Thank you. What about the uptake for biosimilar HUMIRA? Angela?

謝謝你。生物仿製藥 HUMIRA 的使用情況如何？安吉拉？

So we are optimistic about the uptake of biosimilars. I think we've learned a lot over the last several years. And if you look at our experience with Inflectra, you look at our experience recently with our 6 biosimilars in oncology, I mean, they've just -- they've gained tremendous market share. I think that physicians and institutions have become extremely comfortable with the use of biosimilars.

因此，我們對生物仿製藥的採用持樂觀態度。我認為我們在過去幾年中學到了很多東西。如果你看看我們在 Inflectra 方面的經驗，你看看我們最近在腫瘤學領域使用 6 種生物仿製藥的經驗，我的意思是，他們剛剛獲得了巨大的市場份額。我認為醫生和機構已經對使用生物仿製藥感到非常滿意。

If I compare my experience with Inflectra when that was first launched infliximab and I compare that to what I see now with the 6 biosimilars we just launched in oncology, very different experiences in terms of willingness, in terms of uptake and comfort for a physician to use it. So I think we're very far from where we were when we first launched our first biosimilar here in the U.S. That, coupled with the interchangeability data, should mean that we would be able to gain a fair market share.

如果我將我與 Inflectra 首次推出英夫利昔單抗時的經驗進行比較，並將其與我現在看到的與我們剛剛在腫瘤學領域推出的 6 種生物仿製藥進行比較，就醫生的意願、接受度和舒適度而言，體驗截然不同。用它。所以我認為我們離我們在美國首次推出我們的第一個生物仿製藥時的位置還很遠。再加上可互換性數據，應該意味著我們將能夠獲得公平的市場份額。

Your next question comes from the line of Geoff Meacham with Bank of America.

您的下一個問題來自美國銀行的 Geoff Meacham。

This is Alex Hammond on for Geoff Meacham. Maybe to follow up on the previous response. What's the PAXLOVID capacity like? To what extent is guidance potentially constrained by any limiting factor, whether in terms of production or potentially distribution? In other words, if the contracts were there, to what extent do you think they could address the near term? And then can you maybe comment on the pace of business development? As we think about some of your longer-term growth targets and where you sit now, those gaps, are you still comfortable with the current trajectory?

這是 Geoff Meacham 的 Alex Hammond。也許是為了跟進之前的回應。 PAXLOVID 容量如何？指導在多大程度上可能受到任何限制因素的限制，無論是在生產還是潛在的分銷方面？換句話說，如果合同在那裡，您認為它們可以在多大程度上解決短期問題？然後你能評論一下業務發展的步伐嗎？當我們考慮您的一些長期增長目標以及您現在所處的位置時，這些差距，您是否仍然對當前的軌跡感到滿意？

On the PAXLOVID capacity, we are on plan. So we will make 30 million treatments available this year -- excuse me, this June, the first half of the year. And we have already built our capacity, we can make 120 million by the end of the year. I don't think, given this very high ramp-up, that capacity will become a limiting factor to governments to place orders. And anyway, as we see, we don't have situations that they are placing orders that they keep in their warehouse. So they are placing orders so that they can use it so it's always manageable reordering.

在 PAXLOVID 容量上，我們正在計劃中。因此，今年我們將提供 3000 萬種治療方法——對不起，今年 6 月，今年上半年。而且我們已經建立了產能，到年底我們可以做到1.2億。我不認為，鑑於如此高的增長，產能將成為政府下訂單的限制因素。無論如何，正如我們所看到的，我們沒有遇到他們下訂單並保留在倉庫中的情況。所以他們正在下訂單，以便他們可以使用它，因此它始終是可管理的重新排序。

And we will be able to meet this demand. Particularly, we are cognizant that waves are coming so far not necessarily in terms of seasonality, but everybody expects that when you come after mass gatherings in the summer or as we are entering into the flu season, there will be, let's say, dramatic uptake. So in that period of time, we have really a lot of PAXLOVID available. So I don't foresee any issues on that. And then on the -- what was the second part?

我們將能夠滿足這一需求。特別是，我們認識到，到目前為止，浪潮的到來不一定是季節性的，但每個人都希望，當你在夏天的大規模集會之後或我們進入流感季節時，將會有戲劇性的吸收.所以在那段時間裡，我們真的有很多可用的 PAXLOVID。所以我預計這方面不會有任何問題。然後——第二部分是什麼？

Pace of business development.

業務發展步伐。

The pace of business development. Aamir, do you want to take that?

業務發展步伐。阿米爾，你要接受嗎？

Sure. Alex, thanks for the question. You heard Albert very clearly reiterate our commitment to the $25 billion in risk-adjusted revenue by 2030, and we fully believe that we can and will get there. We're going to be very active in BD and that also means being thoughtful and thorough and disciplined. So when we see a great opportunity, we're not going to hesitate to move fast, and I think some of our recent deals are good examples of that. And our ReViral acquisition is a good example of our first move towards that goal. And at the same time, we're not going to be hurried or cavalier just for the sake of doing deals quickly. So we will move fast, we'll be thoughtful, we'll be disciplined, and we are very confident in the aspiration that we've put out.

當然。亞歷克斯，謝謝你的問題。你聽到 Albert 非常清楚地重申了我們對到 2030 年實現 250 億美元風險調整收入的承諾，我們完全相信我們能夠並且將會實現這一目標。我們將在 BD 中非常活躍，這也意味著要周到、徹底和自律。所以當我們看到一個很好的機會時，我們會毫不猶豫地快速行動，我認為我們最近的一些交易就是很好的例子。我們收購 ReViral 就是我們朝著這個目標邁出的第一步的一個很好的例子。同時，我們不會為了快速完成交易而匆忙或漫不經心。所以我們會快速行動，我們會深思熟慮，我們會遵守紀律，我們對我們提出的願望非常有信心。

And I want to, once more, to reiterate. We think there is substrate to do good deals that will provide us $30 billion risk adjusted. But we are going to be very disciplined. We can accomplish that. It is -- I will accomplish all of that without compromising on financial returns that are expected. And we truly feel that we can accomplish both. And we will accomplish, of course, in the next few years we need to do to complete this activity so that we will be able to have an impact in the '25 to 2030 period of time. But I reiterate, there is substrate to do good deals and we will do a lot, but only good deals.

我想再次重申。我們認為有足夠的基礎來進行良好的交易，這將為我們提供 300 億美元的風險調整後收益。但我們會非常自律。我們可以做到這一點。它是——我將在不影響預期財務回報的情況下完成所有這些工作。我們真的覺得我們可以做到這兩點。當然，我們將在未來幾年內完成這項活動，以便我們能夠在 25 到 2030 年期間產生影響。但我重申，做好的交易是有基礎的，我們會做很多，但只有好的交易。

$25 billion by 2030.

到 2030 年達到 250 億美元。

$25 billion by 2030. What did I say?

到 2030 年達到 250 億美元。我說了什麼？

You said $30 billion.

你說300億美元。

$25 billion by 2030, not $30 billion.

到 2030 年是 250 億美元，而不是 300 億美元。

Your final question comes from the line of Robyn Karnauskas with Truist Securities.

您的最後一個問題來自 Truist Securities 的 Robyn Karnauskas。

So just first on PAXLOVID contracts. You had mentioned that there's a bucket of contracts where you're further away from signing. Can you just give a little bit more color on what the rate-limiting steps are for signing in those countries or signing those contracts? Are they in areas where there's less infection, for example? And then second, on the booster, just a follow-up question. It seems like there's a lot of debate about how long the immunity lasts with the boosters. And so how far away do you think we are scientifically from a longer-lasting mRNA booster?

所以首先是 PAXLOVID 合同。你曾提到，還有一大堆合同距離簽署還有更遠的距離。您能否就在這些國家/地區簽署或簽署這些合同的限速步驟提供更多顏色？例如，他們是否在感染較少的地區？其次，關於助推器，只是一個後續問題。似乎有很多關於增強劑免疫持續多長時間的爭論。那麼你認為我們離更持久的 mRNA 增強劑還有多遠？

Fantastic questions. Angela, what about the contracts?

奇妙的問題。安吉拉，合同呢？

So they're not infection-related. It literally is just time. We have many countries to get to, and each one of them have their own internal process to -- that they need to go through. So there really is nothing here other than just getting through at end time.

所以它們與感染無關。從字面上看，這只是時間。我們有很多國家要去，每個國家都有自己的內部流程——他們需要經歷這些。所以這裡真的沒有什麼，除了在結束時通過。

Thank you, Angela. On the booster, let me make also some final comments because we are out of time and also try to answer that one. Clearly, COVID, it is a main uncertainty for the world and for, let's say, companies, but they are trying to make a difference with COVID. But I think we don't know the future but there are some scenarios that are the most likely.

謝謝你，安吉拉。關於補充包，讓我也做一些最後的評論，因為我們沒時間了，也試著回答那個。顯然，COVID 是世界和公司的主要不確定性，但他們正試圖通過 COVID 有所作為。但我認為我們不知道未來，但有一些最有可能發生的情況。

I believe that the most likely another you should be seeing right now, it is that the virus will be around and the virus will mutate. And we know that the characteristic of this virus, is in addition to mutations, it is that doesn't produce long-lasting immune protection, not only through vaccinations but also through natural infection. People that are getting sick, they will get sicker because they can get again sick with different or with the same variant. We know that after some time.

我相信你現在應該看到的最有可能的另一個是，病毒將會存在並且病毒會發生變異。而且我們知道這種病毒的特徵，除了突變之外，它不會產生持久的免疫保護，不僅通過疫苗接種，而且通過自然感染。生病的人會病得更重，因為他們可能會因不同或相同的變體再次生病。一段時間後我們就知道了。

The second thing that we know, it is that the social distancing measures that were the main way to control the disease spread in the first 2 years of the pandemic. The pandemic will ease. It is happening because now have authorities, they do have a treatment in their hand, which they can count so they can release, let's say, the measures they are not as skeptical as before to see overwhelming of hospitals. But also, it is happening because the societies are pushing for that. So there is a tremendous pressure across the world to get our lives back. As a result of these things, it's very clear that we will have waves, that we will be more and more going to be affecting people. And for that, we need to have constant vaccinations, compliance with the vaccinations and the effective treatment.

我們知道的第二件事是，在大流行的前兩年，作為控制疾病傳播的主要方式的社會隔離措施。疫情會緩解。之所以發生這種情況，是因為現在有了當局，他們手中確實有一種治療方法，他們可以計算，這樣他們就可以發布，比如說，他們不像以前那樣對醫院不堪重負的措施持懷疑態度。而且，它正在發生，因為社會正在推動這一點。因此，全世界都面臨著恢復我們生活的巨大壓力。由於這些事情，很明顯我們將掀起波瀾，我們將越來越多地影響人們。為此，我們需要不斷接種疫苗，遵守疫苗接種和有效治療。

Right now, people, it's clear that they are skeptical in vaccines that is not clear if they will be needed to take another 1 and another 1. People are tired from the repeated booster. So it is extremely important to come to a vaccine that could be a yearly vaccine. And to that, it's not technically easy to achieve. It is but we are having very good scientific leads on that. So we are working on that. So when it comes to vaccines, I think this is what needs to be the next steps to be able to stay ahead of the virus, which we are in terms of the new variants but also try to go to the next generation that will be vaccine.

現在，人們很清楚，他們對疫苗持懷疑態度，不清楚是否需要再服用 1 劑和 1 劑。人們因反復加強免疫而感到疲倦。因此，研製一種可以每年接種一次的疫苗非常重要。而且，這在技術上並不容易實現。確實如此，但我們在這方面擁有非常好的科學線索。所以我們正在努力。因此，在疫苗方面，我認為這是能夠保持領先於病毒的下一步需要採取的措施，我們在新變種方面也是如此，但也試圖進入將成為疫苗的下一代.

And of course, when it comes to the treatments, we need to make sure that we go with the manufacturing and the liability because the usage, unfortunately, I expect the need, let me put that, with the need, unfortunately, I think will increase as we are moving to less social distancing measures and that's our reality. So that's how I wanted to answer the booster question in terms of a long-acting booster.

當然，在治療方面，我們需要確保我們遵循製造和責任，因為使用，不幸的是，我預計需要，讓我說一下，不幸的是，我認為需要隨著我們轉向減少社交距離措施而增加，這就是我們的現實。這就是我想用長效助推器來回答助推器問題的方式。

And I want also to thank you, everyone, for today's call. We are seeing very strong signs of increasing demand for PAXLOVID as it remains one of the best tools we have. I'm proud to have been able to recruit some of the best and brightest external minds to add to our talented roster of people. I'm proud that we have been named the most patient-centric company based on feedback from more than 2,000 patient organizations and associations. It's a testament to the important and innovative work our colleagues do every day in pursuit of our purpose.

我還要感謝大家今天的電話。我們看到了對 PAXLOVID 需求增加的強烈跡象，因為它仍然是我們擁有的最好的工具之一。我很自豪能夠招募到一些最優秀、最聰明的外部人才來加入我們才華橫溢的人才名單。我很自豪我們根據來自 2,000 多個患者組織和協會的反饋被評為最以患者為中心的公司。這證明了我們的同事每天為實現我們的目標所做的重要而創新的工作。

And I want to close once more by thanking Frank about his tremendous contributions and his friendship to not only me but many of the executives at Pfizer, and wish him well in his after-Pfizer life, although as he said, he remains a major shareholder so he will be attending everything that's happening here with a lot of attention. Thank you very much, everyone.

最後，我想再次感謝弗蘭克，感謝他對我和輝瑞許多高管的巨大貢獻和友誼，並祝愿他在輝瑞之後的生活中一切順利，儘管正如他所說，他仍然是大股東所以他會非常關注這裡發生的一切。非常感謝大家。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。