輝瑞 (PFE) 2022 Q4 法說會逐字稿

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

大家好，歡迎來到輝瑞公司 2022 年第四季度收益電話會議。今天的通話正在錄音中。在這個時候，我想把電話轉給高級副總裁兼首席投資者關係官 Chris Stevo 先生。請繼續，先生。

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

謝謝你，切爾西。早上好。歡迎來到輝瑞第四季度財報電話會議。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 Dave Denton；以及全球研發和醫療總裁 Mikael Dolsten 博士。參加問答環節的還有全球生物製藥業務首席商務官兼總裁 Angela Hwang；我們的首席業務創新官 Aamir Malik；我們的首席開發官 William Pao 博士；和我們的總法律顧問 Doug Lankler。

Before we begin the call, I want to remind you of some logistical items. 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 as well as in our SEC Forms 10-K and 10-Q under Risk Factors and Forward-Looking Information and Factors that May Affect Future Results.

在我們開始通話之前，我想提醒您一些後勤事項。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。請參閱我們在幻燈片 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 GAAP 財務措施的更多信息，請參閱我們的收益發布以及我們的 SEC 10-K 和 10-Q 表格中的風險因素和前瞻性 -查看可能影響未來結果的信息和因素。

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.

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。

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

有了這個，我會把電話轉給阿爾伯特。

Thank you, Chris. Hello, everyone, and thank you for joining us today. During this morning's call, I will touch on some of our highlights from 2022 and share some thoughts regarding Pfizer's exciting near- and long-term growth plans. 2022 was an outstanding year for Pfizer on multiple fronts. We exceeded $100 billion in revenues for the first time in our 174-year history. We maintained our industry-leading clinical success rates and further improved our cycle times, which were already were among the industry's best. We were named to 10 different best employer lists, including those published by Forbes, LinkedIn, Glassdoor and others. And most important, more than 1.3 billion patients around the world were treated with our medicines and vaccines, a truly humbling achievement.

謝謝你，克里斯。大家好，感謝您今天加入我們。在今天上午的電話會議上，我將談及我們 2022 年的一些亮點，並分享有關輝瑞令人興奮的近期和長期增長計劃的一些想法。 2022 年是輝瑞在多個方面表現出色的一年。在我們 174 年的歷史中，我們的收入首次超過 1000 億美元。我們保持了行業領先的臨床成功率，並進一步改善了我們的周期時間，這已經是行業最佳之一。我們入選了 10 個不同的最佳雇主名單，包括福布斯、LinkedIn、Glassdoor 等發布的名單。最重要的是，全世界有超過 13 億患者接受了我們的藥物和疫苗治療，這是一項真正令人謙卑的成就。

Our key growth drivers for the full year 2022 included global sales of PAXLOVID, strong growth of COMIRNATY in developed markets, the launch of Prevnar 20 for the adult population in the U.S., the continued strong growth of Eliquis globally, the strength of our VYNDAQEL family globally and the addition of newly acquired products, Nurtec ODT, VYDURA and Oxbryta. Looking ahead, we foresee strong operational growth of 7% to 9% in 2023, excluding revenues from our COVID-19 products and the impact of foreign exchange. We expect our potential new launches, newly acquired products and in-line products with all -- will all contribute to this growth.

我們 2022 年全年的主要增長動力包括 PAXLOVID 的全球銷售、COMIRNATY 在發達市場的強勁增長、針對美國成年人口的 Prevnar 20 的推出、Eliquis 在全球的持續強勁增長、我們 VYNDAQEL 家族的實力全球範圍內，並增加了新收購的產品 Nurtec ODT、VYDURA 和 Oxbryta。展望未來，我們預計 2023 年的運營將實現 7% 至 9% 的強勁增長，其中不包括 COVID-19 產品的收入和外彙的影響。我們預計我們潛在的新產品發布、新收購的產品和所有在線產品都將為這一增長做出貢獻。

These projections include our forecast for several important potential product launches, including our RSV vaccine for older adults, potential Prevnar 20 pediatric indication and products and candidates that came to us through recent business development activities, including etrasimod for ulcerative colitis, Nurtec and zavegepant for migraine and Oxbryta for sickle cell disease. We are in the midst of an 18-month period during which we expect to have up to an unprecedented 19 new products or indications in the market. 15 of these 19 are from our internal pipeline, with the remaining 4 coming to Pfizer, as just explained, via the recent business development deals.

這些預測包括我們對幾個重要的潛在產品發布的預測，包括我們針對老年人的 RSV 疫苗、潛在的 Prevnar 20 兒科適應症以及通過最近的業務發展活動向我們提供的產品和候選產品，包括用於潰瘍性結腸炎的 etrasimod、用於偏頭痛的 Nurtec 和 zavegepant和 Oxbryta 用於鐮狀細胞病。我們正處於為期 18 個月的時期，在此期間我們預計將有多達 19 種前所未有的新產品或適應症上市。這 19 人中有 15 人來自我們的內部渠道，其餘 4 人通過最近的業務發展交易進入輝瑞。

Recognizing the importance of these potential launches as well as those expected in 2024 to both Pfizer and the patients who rely on our innovations, we are increasing the support we are putting behind them by investing an incremental $1.3 billion in SI&A expenses in 2023. Dave will provide more details on these investments during the presentation.

認識到這些潛在上市以及 2024 年預期上市對輝瑞和依賴我們創新的患者的重要性，我們正在通過在 2023 年增加 13 億美元的 SI&A 費用投資來增加對它們的支持。Dave 將在演示過程中提供有關這些投資的更多詳細信息。

One example of a product that is already benefiting from this additional support is CIBINQO, which recently has seen an improving growth trajectory that we expect to continue through the course of 2023. In the fourth quarter of 2022, CIBINQO's new-to-brand prescriptions grew 84% sequentially, the fastest growth rate in the class. We have started 2023 with 55% commercial formulary access, and we expect that access to continue to improve during the year, especially with the upcoming expected expansion of the U.S. indication to include adolescents 12 to 18 years old, if approved.

CIBINQO 是已經受益於這種額外支持的產品的一個例子，它最近看到了增長軌蹟的改善，我們預計這種增長軌跡將持續到 2023 年。在 2022 年第四季度，CIBINQO 的新品牌處方藥增長連續 84%，是同類產品中最快的增長速度。我們已經從 2023 年開始獲得 55% 的商業處方藥准入率，我們預計這一年的准入率將繼續提高，特別是隨著美國適應症即將擴大到包括 12 至 18 歲的青少年（如果獲得批准）。

We also introduced a new direct-to-consumer campaign in November, which has increased patient awareness of CIBINQO and led to more patients asking their doctors about it. We look forward to the expected U.S. launches of etrasimod in ulcerative colitis and ritlecitinib in alopecia areata, if approved, as well as the expected launch of ABRILADA, our biosimilar to Humira to further expand our franchise in immunology this year.

我們還在 11 月推出了一項新的直接面向消費者的活動，提高了患者對 CIBINQO 的認識，並導致更多患者向他們的醫生諮詢。如果獲得批准，我們期待美國預期推出用於治療潰瘍性結腸炎的 etrasimod 和用於治療斑禿的 ritlecitinib，以及預期推出 ABRILADA，我們與 Humira 的生物仿製藥將在今年進一步擴大我們在免疫學領域的特許經營權。

However, we recognize that investors are not only interested to hear this year's guidance, but also to understand the long-term growth prospects of the company. Particular questions are focused on our plans to offset the expected $17 billion impact of the LOEs between 2025 and 2030 and our long-term projections for our COVID-19 products. We will try to address both, starting with this slide regarding our business, excluding COVID.

然而，我們認識到投資者不僅有興趣聽取今年的指引，而且有興趣了解公司的長期增長前景。具體問題集中在我們抵消 LOE 在 2025 年至 2030 年期間預計產生的 170 億美元影響的計劃以及我們對 COVID-19 產品的長期預測上。我們將嘗試解決這兩個問題，從這張關於我們業務的幻燈片開始，不包括 COVID。

As you can see in this chart, we expect the 15 of the 19 potential launches that are coming from our internal pipeline to generate 2030 revenues that will more than offset the expected LOE losses forecast for '25 to 2030. The potential $20 billion in this chart is a risk-adjusted number. I would also point out that some of the potential launches are expected to be bigger contributors to our growth than others. And if all 15 were to achieve their full potential, this figure could go even higher.

正如您在此圖表中看到的，我們預計來自我們內部管道的 19 項潛在發射中的 15 項將產生 2030 年的收入，這將超過抵消 25 到 2030 年的預期 LOE 損失預測。這可能有 200 億美元圖表是風險調整後的數字。我還要指出，一些潛在的發布預計將比其他的對我們的增長做出更大的貢獻。如果所有 15 人都充分發揮其潛力，這個數字可能會更高。

In addition, we believe we have the ability, if successful, to add at least $25 billion of risk-adjusted revenues to our 2030 top line expectations through business development activity. As we have said previously, we believe the deals we have already done for Arena, Biohaven, Global Blood Therapeutics and ReViral have the potential to get us more than 40% of the way there with approximately $10.5 billion in expected 2030 revenues. I am very pleased to see that the analysts' consensus expectations for the same revenues have already reached $9.5 billion, closing materially the gap that previously existed between internal and external expectations.

此外，我們相信，如果成功，我們有能力通過業務發展活動將至少 250 億美元的風險調整後收入增加到我們 2030 年的收入預期。正如我們之前所說，我們相信我們已經為 Arena 、 Biohaven 、 Global Blood Therapeutics 和 ReViral 完成的交易有可能使我們實現 40% 以上的目標，到 2030 年的預期收入約為 105 億美元。我很高興看到分析師對相同收入的一致預期已經達到 95 億美元，大大縮小了內部和外部預期之間先前存在的差距。

Four of these products have already launched or are expected to launch, subject to regulatory approval in 2023. We also have more than enough capital to invest in the additional opportunities needed to meet or exceed this target. And of course, we have many more potential vaccines and medicines in our pipeline, with numerous launches expected in the '24 to 2030 time frame, if successful in clinical trials and approved. Some of the most promising assets include our oral GLP-1 candidate for diabetes and obesity. All of them are under this dotted box, XB. Potential combo vaccines for flu, COVID-19 and RSV; our potential vaccines for Lyme disease and shingles; multiple new oncology product candidates, including ARV-471 and our CDK4 inhibitor for endocrine receptor-positive breast cancer; our gene therapy candidates for hemophilia A, hemophilia B and Duchenne muscular dystrophy; our pan-hemophilia A and B antibody treatment; and many more.

其中四種產品已經推出或預計將在 2023 年獲得監管批准。我們也有足夠的資金投資於實現或超過這一目標所需的額外機會。當然，我們還有更多潛在的疫苗和藥物正在準備中，如果臨床試驗成功並獲得批准，預計將在 24 到 2030 年的時間框架內推出大量產品。一些最有前途的資產包括我們用於糖尿病和肥胖症的口服 GLP-1 候選藥物。所有這些都在這個虛線框下，XB。流感、COVID-19 和 RSV 的潛在聯合疫苗；我們潛在的萊姆病和帶狀皰疹疫苗；多個新的腫瘤候選產品，包括 ARV-471 和我們用於內分泌受體陽性乳腺癌的 CDK4 抑製劑；我們針對 A 型血友病、B 型血友病和 Duchenne 肌營養不良症的基因治療候選藥物；我們的泛血友病 A 和 B 抗體治療；還有很多。

If approved, we expect each of these to be key incremental contributors to our growth aspirations through '25 and beyond. Even without any of these additional potential products, we expect our '25 to 2030 revenue CAGR to be approximately 6%. And if some of them are successful, the CAGR could exceed 10%.

如果獲得批准，我們預計其中每一項都將成為我們實現 25 歲及以後增長願望的關鍵增量貢獻者。即使沒有任何這些額外的潛在產品，我們預計我們 25 到 2030 年的收入複合年增長率約為 6%。如果其中一些成功，複合年增長率可能會超過 10%。

Now let me turn my attention to our COVID-19 portfolio. At the JPMorgan conference earlier this month, I spoke about expecting 2023 to be a transition year, representing a low point in our COVID-related revenues. Let me provide a little bit more color on that. I will start with COMIRNATY in the U.S. as an example. In 2022, 31% of the population or 104 million Americans received an average 1.4 doses of COVID-19 vaccines for a total of 144 million doses. COMIRNATY's share was 64% or 92 million of these 144 million doses, as you can see in the first column.

現在讓我將注意力轉向我們的 COVID-19 產品組合。在本月早些時候的摩根大通會議上，我談到預計 2023 年將是一個過渡年，代表我們與 COVID 相關的收入處於低點。讓我提供更多的顏色。我將以美國的 COMIRNATY 為例。 2022 年，31% 的人口或 1.04 億美國人平均接種了 1.4 劑 COVID-19 疫苗，總計 1.44 億劑。正如您在第一列中看到的那樣，COMIRNATY 的份額為這 1.44 億劑中的 64% 或 9200 萬劑。

In 2023, we expect about 24% of the population or 79 million people to receive vaccine doses for COVID during this year. This drop is due to expected fewer primary vaccinations and reduced compliance with recommendations. We expect they will receive about 1.3 doses per person on average in 2023. The drop is because fewer people are expected to receive their primary doses and, for the most part, only those who are older or at higher risk are expected to continue receiving more than 1 booster per year. This should result in about 102 million total vaccine doses administered in 2023. We believe Pfizer will maintain at least 64% markets share and therefore expect about 65 million doses of the Pfizer-BioNTech vaccine to be administered in 2023.

到 2023 年，我們預計大約 24% 的人口或 7900 萬人將在這一年內接種 COVID 疫苗。這一下降是由於預計初級疫苗接種減少和對建議的遵守程度降低。我們預計他們將在 2023 年平均每人接種約 1.3 劑疫苗。下降的原因是預計接受主要劑量的人數減少，並且在大多數情況下，只有年齡較大或風險較高的人預計會繼續接受更多劑量每年超過 1 個助推器。這應該會導致到 2023 年接種約 1.02 億劑疫苗。我們認為輝瑞將保持至少 64% 的市場份額，因此預計 2023 年將接種約 6500 萬劑輝瑞-BioNTech 疫苗。

In 2024, we expect the utilization rates and market share figures to stabilize and come in roughly the same as in 2023. Then starting in '25 and continuing in '26 and beyond, we expect to see an increase in COVID-19 vaccination rates, assuming the successful development and approval of the COVID/flu combination product. A successful introduction of a COVID/flu combo could, over time, bring the percentage of Americans receiving the COVID-19 vaccine closer to the portion of people getting flu shots, which is currently about 50%. Outside the U.S., we expect these general trends to be similar, with some variations from country to country.

到 2024 年，我們預計利用率和市場份額數據將穩定下來並與 2023 年大致持平。然後從 25 年開始並持續到 26 年及以後，我們預計 COVID-19 疫苗接種率會增加，假設成功開發並批准了 COVID/flu 組合產品。隨著時間的推移，成功引入 COVID/流感組合可以使接受 COVID-19 疫苗的美國人的比例更接近接種流感疫苗的人的比例，目前這一比例約為 50%。在美國以外，我們預計這些總體趨勢是相似的，但因國家/地區而異。

So what does this mean for our revenues? We expect 2023 to be a transition year in the U.S. In 2022, we sold at pandemic prices more doses than were eventually used. This resulted in a government inventory build that we expect to be absorbed sometime in 2023, probably the second half of the year. Around that time, we expect to start selling COMIRNATY through commercial channels at commercial prices. We expect that in years 2024 and beyond, the doses sold and doses used in a year will more closely align together and the commercial price to remain relatively stable with only inflation-like price increases.

那麼這對我們的收入意味著什麼呢？我們預計 2023 年將成為美國的過渡年。2022 年，我們以大流行病價格出售的劑量比最終使用的劑量多。這導致政府庫存增加，我們預計將在 2023 年某個時候（可能是下半年）吸收。大約在那時，我們預計將開始通過商業渠道以商業價格銷售 COMIRNATY。我們預計在 2024 年及以後，一年中銷售的劑量和使用的劑量將更加緊密地結合在一起，商業價格將保持相對穩定，只有類似通貨膨脹的價格上漲。

Now let me briefly run through PAXLOVID. In2022, we estimate that 110 million COVID-19 symptomatic infections were reported in the world, excluding China. Approximately 12% of them were treated with approximately 14 million oral therapy courses. And PAXLOVID had the lion's share of them with approximately 90% market share. Average was 86%, but in the second half of the year exceeded the 90%. Keep in mind that this reflects a full year of reported infections, but only a partial year of PAXLOVID availability due to supply constraints in the first quarter of 2022.

現在讓我簡要介紹一下 PAXLOVID。 2022 年，我們估計全球報告了 1.1 億例 COVID-19 症狀性感染，不包括中國。其中約 12% 接受了約 1400 萬個口服治療療程。而 PAXLOVID 佔據了其中的大部分份額，市場份額約為 90%。平均為86%，但下半年超過了90%。請記住，這反映了一整年的感染報告，但由於 2022 年第一季度的供應限制，PAXLOVID 的可用性只有部分年份。

In '23 and beyond, we expect infections to increase slightly at 2% annually due to waning immune protection of the population, resulting from reduced vaccination rates. Similarly, we expect treatment rates to increase as awareness, education and additional oral entries will grow the oral antiviral market. Finally, we expect PAXLOVID to maintain very high share despite additional competitive entries, given its strong benefit-risk profile and brand recognition.

在 23 年及以後，由於疫苗接種率降低導致人群免疫保護減弱，我們預計感染率將以每年 2% 的速度略有增加。同樣，我們預計治療率會隨著意識、教育和更多口服藥物的使用而增加，這將推動口服抗病毒藥物市場的增長。最後，鑑於 PAXLOVID 強大的收益風險狀況和品牌知名度，我們預計儘管有更多的競爭進入，但 PAXLOVID 仍將保持非常高的份額。

So what does this mean for revenues? As with COMIRNATY, we expect 2023 to be a transition year for PAXLOVID as well. In 2022, we sold at pandemic prices more treatment courses than were eventually used. This resulted in a government inventory build that we expect to be absorbed sometime in 2023, probably second half. Around that time, we expect to start selling PAXLOVID through the commercial channels at commercial prices. We expect in years 2024 and beyond, that the courses sold and used will align closely together within every year.

那麼這對收入意味著什麼呢？與 COMIRNATY 一樣，我們預計 2023 年也將是 PAXLOVID 的過渡年。 2022 年，我們以大流行病價格售出的療程數量超過了最終使用的療程數量。這導致政府庫存增加，我們預計將在 2023 年某個時候（可能是下半年）吸收。大約在那時，我們預計將開始通過商業渠道以商業價格銷售 PAXLOVID。我們預計在 2024 年及以後，銷售和使用的課程將在每一年內緊密結合在一起。

There has been a great deal of speculation regarding the new but uncertain market opportunity for PAXLOVID in China, so let me share what we are seeing. We have an agreement with one company to import and distribute PAXLOVID in China, a local company, and we have a manufacturing agreement with another local Chinese company for local manufacturing. Pfizer shipped only tens of thousands of courses to China in fiscal year 2022. From December, which is the first month of our non-U.S. fiscal year through March, we expect to ship millions of courses to meet local demand.

關於 PAXLOVID 在中國的新的但不確定的市場機會有很多猜測，所以讓我分享一下我們所看到的。我們與一家公司簽訂了在中國進口和分銷 PAXLOVID 的協議，這是一家本地公司，我們還與另一家中國本地公司簽訂了本地製造協議。輝瑞在 2022 財年僅向中國運送了數万個課程。從 12 月（我們非美國財年的第一個月）到 3 月，我們預計將運送數百萬個課程以滿足當地需求。

We expect we will be able to sell effectively under government reimbursement through end of March. And despite China's recent decision not to include PAXLOVID on the country's natural drug reimbursement list, we expect to offer the product on the private market after April 1 unless, of course, a listing opportunity opens up before then.

我們預計到 3 月底，我們將能夠在政府補償下有效銷售。儘管中國最近決定不將 PAXLOVID 列入該國的天然藥物報銷清單，但我們預計將在 4 月 1 日之後在私人市場上提供該產品，當然，除非在此之前出現上市機會。

Lastly, I want to point out that while we are expecting increased utilization in all regions of the world as infections increase, we are not including any major non-U.S. or non-China contracts in our 2023 forecasts.

最後，我想指出，雖然我們預計隨著感染的增加，世界所有地區的利用率都會增加，但我們在 2023 年的預測中並未包括任何主要的非美國或非中國合同。

Let me close with a few thoughts regarding our scientific engine. R&D continues to be the lifeblood that fuels us as a company, which is why we plan to increase our R&D spend by at least 8.7% in 2023 to $12.4 billion and $13.4 billion range. In addition to the increased investments, we are taking steps not only to further improve our industry-leading success rates and cycle times, but also to increase overall return on investment and R&D productivity. As you have seen in the last year, we continuously prioritize our pipeline to focus on the assets that represent potential breakthroughs and have the potential for generating higher returns, putting more capital behind larger opportunities like GLP-1, flu, elranatamab and others.

讓我以關於我們的科學引擎的一些想法作為結束。研發仍然是推動我們公司發展的命脈，這就是為什麼我們計劃在 2023 年將研發支出至少增加 8.7% 至 124 億美元和 134 億美元之間。除了增加投資外，我們正在採取措施，不僅進一步提高我們行業領先的成功率和周期時間，而且還提高整體投資回報率和研發生產力。正如你在去年看到的那樣，我們不斷優先考慮我們的管道，專注於代表潛在突破並有可能產生更高回報的資產，將更多資金投入到更大的機會，如 GLP-1、流感、elranatamab 等。

We are at an infection point -- and we are at an inflection point to act from a position of strength with our best-in-class R&D productivity, a robust pipeline of innovative assets and one of the highest R&D budgets in the industry.

我們正處於一個感染點——我們正處於一個拐點，以我們一流的研發生產力、強大的創新資產管道和業內最高的研發預算之一，從優勢地位採取行動。

With that, I will turn it over to Dave to provide details on our fourth quarter performance and our outlook for 2023. After Dave, Mikael will provide an update on our R&D pipeline. Take it over, Dave.

有了這個，我將把它交給 Dave 來提供我們第四季度業績的詳細信息和我們對 2023 年的展望。在 Dave 之後，Mikael 將提供我們研發管道的最新情況。拿過來，戴夫。

Great. Thank you, Albert, and good morning, everyone. Albert has already taken you through many of the key drivers of our full year performance, so I will focus my opening remarks on some key highlights from the fourth quarter. Revenues grew operationally 13%, primarily driven by COMIRNATY's strong growth in developed markets, following the slowdown in deliveries that we discussed in the third quarter, ahead of the rollout of the bivalent booster. We also saw very strong performance from PAXLOVID outside the U.S. and the ongoing launch of Prevnar 20 for adults within the U.S.

偉大的。謝謝你，艾伯特，大家早上好。 Albert 已經向您介紹了我們全年業績的許多關鍵驅動因素，因此我將在開場白中重點介紹第四季度的一些關鍵亮點。營業收入增長 13%，主要受 COMIRNATY 在發達市場的強勁增長推動，繼我們在第三季度討論的交付放緩之後，在二價助推器推出之前。我們還看到 PAXLOVID 在美國以外的市場表現非常強勁，並且正在為美國成人推出 Prevnar 20。

Excluding direct sales and alliance revenues related to our COVID-19 products, Pfizer's revenues grew 5% operationally in the quarter. And if recently acquired products from Biohaven and GBT are also excluded, revenues were up approximately 3% in Q4. Reported diluted earnings per share this quarter grew 48% to $0.87, while adjusted diluted earnings per share of $1.14 grew 69% on an operational basis in the quarter. Both EPS figures include a $0.32 benefit from lower acquired IPR&D expenses compared to last year's fourth quarter.

不包括與我們的 COVID-19 產品相關的直接銷售和聯盟收入，輝瑞本季度的運營收入增長了 5%。如果最近從 Biohaven 和 GBT 收購的產品也被排除在外，第四季度的收入增長了約 3%。本季度報告的攤薄每股收益增長 48% 至 0.87 美元，而調整後的攤薄每股收益 1.14 美元在本季度的運營基礎上增長了 69%。與去年第四季度相比，這兩個每股收益數字都包括 0.32 美元的收益，這是因為獲得的 IPR&D 費用較低。

Once again, in the quarter, foreign exchange movement significantly impacted our results, reducing fourth quarter revenues by approximately $2.5 billion or 11%, and adjusted diluted earnings per share by $0.19 or 24% compared to LY. On a full year basis, foreign exchange negatively impacted revenues by $5.5 billion or 7%, and adjusted diluted earnings per share by $0.36 or 9%.

在本季度，外匯變動再次對我們的業績產生重大影響，與 LY 相比，第四季度收入減少約 25 億美元或 11%，調整後的攤薄每股收益減少 0.19 美元或 24%。按全年計算，外匯對收入產生了 55 億美元或 7% 的負面影響，調整後的攤薄每股收益為 0.36 美元或 9%。

Turning now to 2023 and the financial outlook for the company. Let me first point out that our approach to guidance in 2023 is fundamentally different than prior years. Given the expected transition to commercial markets for our COVID franchise and away from an advanced purchase agreement environment, our guidance reflects our best estimates for both revenues and profits for these products for the full year, not just what has been contractually secured.

現在轉向 2023 年和公司的財務前景。首先讓我指出，我們對 2023 年的指導方法與往年根本不同。鑑於我們的 COVID 特許經營權預計將過渡到商業市場，並遠離先進的採購協議環境，我們的指引反映了我們對這些產品全年收入和利潤的最佳估計，而不僅僅是合同保障的內容。

On a total company basis, we expect revenues of between $67 billion to $71 billion, reflecting an operational decline of 31% at the midpoint. Importantly, we expect that revenues from our business, excluding COVID, will grow between 7% and 9% on an operational basis in 2023. That growth is projected to be split between contributions from our new product launches, our recently acquired products as well as our in-line portfolio. The total company revenue declines are entirely driven by our COVID products, which are expected to go from their peak in 2020 to their low point in '23 before potentially returning to growth in '24 and beyond. While patient demand for our COVID products is expected to remain strong throughout 2023, much of that demand is expected to be fulfilled by products that were delivered to governments in '22 and recorded as revenues last year.

就公司整體而言，我們預計收入在 670 億美元至 710 億美元之間，反映出中點運營下降 31%。重要的是，我們預計 2023 年我們的業務收入（不包括 COVID）將在運營基礎上增長 7% 至 9%。這一增長預計將在我們新產品發布、我們最近收購的產品以及我們的在線產品組合。公司總收入的下降完全是由我們的 COVID 產品驅動的，這些產品預計將從 2020 年的峰值下降到 23 年的低點，然後可能在 24 年及以後恢復增長。雖然患者對我們的 COVID 產品的需求預計在整個 2023 年都將保持強勁，但預計大部分需求將由 22 世紀交付給政府並記錄為去年收入的產品來滿足。

Now I want to point out that our total company revenue guidance range is wider than what is implied by the 7% to 9% operational growth rate range for the business excluding COVID. The wider guidance range reflects the potential volatility that we see in our COVID product revenues, given that they can be significantly impacted by factors outside our control, such as the infection rates and the severity of the virus as well as the timing for transitioning to a traditional commercial model here in the U.S.

現在我想指出，我們的公司總收入指導範圍比不包括 COVID 的業務 7% 至 9% 的運營增長率範圍所暗示的範圍更廣。更廣泛的指導範圍反映了我們在 COVID 產品收入中看到的潛在波動，因為它們可能受到我們無法控制的因素的重大影響，例如感染率和病毒的嚴重性以及過渡到美國這裡的傳統商業模式

And you can see on this slide our cost and expense guidance for '23. As I mentioned in my remarks at our investor event in December, both SI&A and R&D expenses are expected to be significantly higher in 2023 versus '22, despite the fact that our overall revenues are coming down. Higher investments in SI&A are significantly focused on the successful launches of the large number of potential new products that Albert highlighted as well as recently acquired assets. Additionally, the expected commercial launch of both COMIRNATY and PAXLOVID in the U.S. will require additional investments as we transition away from the government market. These investments are squarely focused on supporting the company's 2025 to 2030 growth aspirations.

您可以在這張幻燈片上看到我們 23 年的成本和費用指南。正如我在去年 12 月的投資者活動中所說的那樣，儘管我們的整體收入正在下降，但預計 2023 年的 SI&A 和研發費用將比 22 年顯著增加。對 SI&A 的更高投資主要集中在成功推出阿爾伯特強調的大量潛在新產品以及最近收購的資產上。此外，隨著我們從政府市場轉型，預計 COMIRNATY 和 PAXLOVID 在美國的商業上市將需要額外投資。這些投資直接專注於支持公司 2025 年至 2030 年的增長目標。

We also intend to invest significantly in our research efforts this year, with multiple exciting and potentially high-value programs receiving additional funding, including our oral GLP-1 programs, elranatamab and respiratory combination vaccines. All of this spending to support our commercial and research activities, we believe, will not only yield an attractive return but also contribute toward setting us on a path to achieving our long-term growth goals.

我們還打算在今年大力投資於我們的研究工作，多個令人興奮且具有潛在高價值的項目將獲得額外資金，包括我們的口服 GLP-1 項目、elranatamab 和呼吸道聯合疫苗。我們相信，所有這些用於支持我們的商業和研究活動的支出不僅會產生有吸引力的回報，而且有助於讓我們走上實現長期增長目標的道路。

I'd point out that when you exclude revenues and expenses related to our COVID products, our expected operating margin profile this year is largely consistent with the prior year. This reflects incremental investments in SI&A related to launch products and R&D as well as lower acquired IPR&D expenses.

我要指出的是，當你排除與我們的 COVID 產品相關的收入和支出時，我們今年的預期營業利潤率概況與上一年基本一致。這反映了與推出產品和研發相關的 SI&A 的增量投資以及較低的收購 IPR&D 費用。

In 2023, we are investing in both R&D and SI&A in advance of revenue contributions from new products. Looking longer term, we expect this spending will be maintained with the P&L growing into this cost base as new product revenues begin to be fully realized, with margins improving as a result. Given that 2023 is both a year of investment and transition, I thought it would be helpful to outline many of our key assumptions built into our guidance. I don't intend to walk you through all of the elements here, but both Slides 19 and 20 outline many of the details.

2023 年，我們將在新產品的收入貢獻之前投資於研發和 SI&A。從長遠來看，隨著新產品收入開始完全實現，我們預計隨著損益增長到這一成本基礎，這一支出將得到維持，利潤率因此而提高。鑑於 2023 年既是投資又是轉型的一年，我認為概述我們指南中內置的許多關鍵假設會有所幫助。我不打算在這裡向您介紹所有元素，但幻燈片 19 和 20 都概述了許多細節。

In summary, these assumptions include strong revenue growth of 7% to 9% in our business, excluding COVID; additional investments in SI&A and R&D to support Pfizer's near- and longer-term growth plans; continued patient demand for our COVID-related products worldwide, with vaccination rates declining slightly and utilization of treatments slightly increasing; rephasing of the European Commission COMIRNATY contract over multiple years versus full delivery in 2023; and finally, U.S. commercialization of the COVID products in the second half of 2023.

總之，這些假設包括我們業務收入強勁增長 7% 至 9%，不包括 COVID；對 SI&A 和研發的額外投資，以支持輝瑞的近期和長期增長計劃；全球患者對我們 COVID 相關產品的持續需求，疫苗接種率略有下降，治療的使用率略有增加；與 2023 年全面交付相比，歐盟委員會 COMIRNATY 合同在多年內重新定相；最後，美國將在 2023 年下半年將 COVID 產品商業化。

In summary, as we enter a new year, our business is extremely strong with many in-line, acquired and expected launch products capable of driving strong growth with an attractive pipeline of potential products coming in the future. We believe '23 will be an important year for Pfizer, and that is why we are deploying our resources into quality execution in order to fully realize the growth opportunities we see within our portfolio and within our pipeline, which have the potential to impact our growth outlook through 2030 and beyond.

總而言之，隨著我們進入新的一年，我們的業務非常強勁，許多在線、收購和預期推出的產品能夠推動強勁增長，未來將推出一系列有吸引力的潛在產品。我們相信 23 年對輝瑞來說將是重要的一年，這就是為什麼我們將資源部署到質量執行中，以充分實現我們在產品組合和管道中看到的增長機會，這有可能影響我們的增長到 2030 年及以後的展望。

So with that, let me turn it over to Mikael.

因此，讓我把它交給 Mikael。

Thank you, Dave. Today, I want to set the stage for an anticipated catalyst-rich 18 months. As Albert mentioned, we are in a position of unprecedented strength in our history, and I'm excited to share a high-level overview of an evolved strategy for Pfizer R&D to focus our resources on transformative programs which could be most impactful for patients, drive improved return on R&D investment and create the most value. We will leverage and continue to innovate our powerhouse capabilities in medicine design and continue to innovate light-speed drug development to further improve our industry-leading success rates and cycle times.

謝謝你，戴夫。今天，我想為預期的充滿催化劑的 18 個月奠定基礎。正如 Albert 提到的，我們在歷史上處於前所未有的優勢地位，我很高興分享輝瑞研發戰略的高級概述，將我們的資源集中在可能對患者影響最大的變革項目上，推動提高研發投資回報並創造最大價值。我們將利用並繼續創新我們在藥物設計方面的強大能力，並繼續創新光速藥物開發，以進一步提高我們行業領先的成功率和周期時間。

We have rethought our approach to rare disease and will move from having a stand-alone research unit to aligning key programs with other therapeutic areas. We plan to externally advance rare disease programs that do not fit into a core therapeutic area of focus. At the same time, we plan to tap into the expanding external innovation ecosystem by actively pursuing biotech innovation and emerging innovation that fits strategically and accessing external assets that are differentiated. Taken together, we believe these actions will help position us to lead the industry in reaching more patients with the most impactful near-term blockbuster breakthroughs while driving forward the next wave of innovations.

我們重新考慮了我們對罕見疾病的方法，並將從擁有一個獨立的研究部門轉變為將關鍵項目與其他治療領域結合起來。我們計劃從外部推進不適合核心治療領域的罕見病項目。同時，我們計劃通過積極追求與戰略相適應的生物技術創新和新興創新，以及獲取差異化的外部資產，從而進入不斷擴大的外部創新生態系統。總而言之，我們相信這些行動將有助於我們引領行業，在推動下一波創新浪潮的同時，通過最具影響力的近期重磅突破接觸更多患者。

I'm pleased to share some examples with you today. We are pursuing potentially transformative efficacy in our Inflammation & Immunology franchise, with the potential launches of etrasimod in ulcerative colitis and ritlecitinib in alopecia areata, which both have the potential to be blockbusters, and a planned Phase III study start of anti-interferon beta in dermatomyositis and other idiopathic inflammatory myopathies. Our next wave of innovation includes 2 monoclonal antibody candidates for atopic dermatitis, which exemplify our multispecific platform and in-house biomedicine design expertise.

今天很高興與大家分享一些例子。我們正在我們的炎症和免疫學專營權中尋求潛在的變革性功效，可能會推出治療潰瘍性結腸炎的依曲莫德和治療斑禿的利曲替尼，這兩種藥物都有可能成為重磅炸彈，並且計劃在 III 期開始抗干擾素 β 研究皮肌炎和其他特發性炎症性肌病。我們的下一波創新包括 2 個用於特應性皮炎的候選單克隆抗體，這體現了我們的多特異性平台和內部生物醫學設計專業知識。

Two assets currently in Phase I clinical trials each targets 3 cytokines in a single therapeutics, so we refer to them as trispecifics. On the right are Phase I pharmacokinetic profile of the average plasma concentration. For both molecules, the profiles suggest that once a month or even less frequent, subcutaneous dosing may be supported. There is potential for improved efficacy with more potent interleukin-4 and 13 utilization plus an expanded breadth of efficacy by blocking thymic stromal lymphopoietin to potentially cover more endotypes or by blocking interleukin-23 to potentially enhance itch reduction.

目前處於 I 期臨床試驗中的兩項資產在單一療法中各自針對 3 種細胞因子，因此我們將它們稱為三特異性。右邊是平均血漿濃度的 I 期藥代動力學曲線。對於這兩種分子，概況表明可以支持每月一次或更不頻繁的皮下給藥。通過更有效地利用白細胞介素 4 和 13 以及通過阻斷胸腺基質淋巴細胞生成素以潛在覆蓋更多內型或通過阻斷白細胞介素 23 以潛在增強瘙癢減少來擴大療效範圍，有可能提高療效。

The Phase I studies continue. We aim to bolster our 30-year experience in hematology with a strong pipeline that complements our in-line portfolio and collectively has blockbuster potential. I will talk more about elranatamab and GBT601 in a moment. So will highlight here that we expect multiple data readouts for TTI-622 in hematological malignancies, 2 Phase III readouts for inclacumab in sickle cell disease in the second half of '24 and a Phase III readout for marstacimab in patients with hemophilia A or B in second quarter of '23.

I 期研究仍在繼續。我們的目標是通過強大的管道來加強我們在血液學領域 30 年的經驗，以補充我們的在線產品組合，並共同具有重磅炸彈的潛力。稍後我將詳細討論 elranatamab 和 GBT601。所以在這裡強調，我們預計 TTI-622 在血液系統惡性腫瘤中的多個數據讀數，24 年下半年 inclacumab 在鐮狀細胞病中的 2 個 III 期讀數和在血友病 A 或 B 患者中的 marstacimab 的 III 期讀數23 年第二季度。

Marstacimab has FDA Fast Track designation for both hemophilia A and B with inhibitors. If successful, we project submitting for the non-inhibitor indication in both A and B hemophilia in the third quarter of '23. We recently announced positive top line results from a Phase III study of our hemophilia B gene therapy candidate and expect the pivotal readout for our hemophilia A gene therapy in the first half of '24.

Marstacimab 具有 FDA 快速通道指定，用於具有抑製劑的血友病 A 和 B。如果成功，我們計劃在 23 年第三季度提交 A 型和 B 型血友病的非抑製劑適應症。我們最近宣布了我們的血友病 B 基因治療候選藥物的 III 期研究的積極頂線結果，並期待在 24 年上半年對我們的血友病 A 基因治療進行關鍵讀數。

We recently presented strong updated Phase II data on elranatamab, our investigational B-cell maturation antigen, or BCMA, CD3-targeted bispecific antibody for relapsed or refractory multiple myeloma in heavily pretreated patients who had received at least 3 classes of prior therapies. This candidate, which has the potential to be a leader in the BCMA bispecific class, demonstrated a high objective response rate of 61% in patients with no prior BCMA-targeted treatment, early and deep responses and a manageable safety profile.

我們最近提供了關於 elranatamab 的強大更新的 II 期數據，我們的研究 B 細胞成熟抗原，或 BCMA，CD3 靶向雙特異性抗體，用於接受過至少 3 類既往治療的重度預處理患者的複發或難治性多發性骨髓瘤。該候選藥物有潛力成為 BCMA 雙特異性類藥物的領導者，在未接受過 BCMA 靶向治療的患者中表現出 61% 的高客觀反應率、早期和深度反應以及可控的安全性。

Given factors currently limiting the availability of novel therapies in the triple-class exposed setting, elranatamab has the potential to reach a broad and greater number of patients as an off-the-shelf option with reduced dosing frequency that is administered subcutaneously, offering more convenience than intravenous administration.

鑑於目前限制三類暴露環境中新療法可用性的因素，elranatamab 有可能作為一種現成的選擇來覆蓋更廣泛和更多的患者，皮下給藥頻率降低，提供更多便利比靜脈給藥。

With FDA Breakthrough Therapy designation granted last year, elranatamab could potentially be approved this year. As there is blockbuster potential and patient value beyond the triple-class refractory population, our clinical strategy aims to move to earlier lines of therapy and combination approaches with the potential, if successful, for multiple approvals to expand eligibility and duration of therapy.

憑藉去年授予的 FDA 突破性治療指定，elranatamab 有可能在今年獲得批准。由於在三級難治性人群之外存在重磅炸彈的潛力和患者價值，我們的臨床策略旨在轉向更早的治療線和組合方法，如果成功的話，有可能獲得多項批准以擴大治療的資格和持續時間。

Now to our next-generation oral, once-daily hemoglobin S polymerization inhibitor candidate that's in a unique class and has the potential to expand the prophylactic treatment of people with sickle cell disease. Standard-of-care treatment rates have typically been low due to side effects, poor efficacy or both. While Oxbryta made substantial progress in preventing hemoglobin polymerization or sickling, GBT601 is a potentially best-in-class candidate, which may reduce both hemolysis and frequency of vaso-occlusive crisis.

現在是我們的下一代口服、每日一次的血紅蛋白 S 聚合抑製劑候選物，它屬於獨特的一類，有可能擴大對鐮狀細胞病患者的預防性治療。由於副作用、療效不佳或兩者兼而有之，標準護理治療率通常很低。雖然 Oxbryta 在防止血紅蛋白聚合或鐮狀化方面取得了實質性進展，但 GBT601可能是同類最佳候選藥物，它可能會減少溶血和血管閉塞危機的發生頻率。

The most recent data from our Phase I multiple-ascending dose study showed improvements in hematocrit and hemoglobin levels over time, mean hemoglobin occupancy of more than 32% for the 100-milligram maintenance dose and more than 41% for the 150-milligram maintenance dose and improvements in red blood cell health with the higher maintenance doses. The maintenance doses were well tolerated.

我們的 I 期多劑量遞增研究的最新數據顯示，隨著時間的推移，血細胞比容和血紅蛋白水平有所改善，100 毫克維持劑量的平均血紅蛋白佔有率超過 32%，150 毫克維持劑量的平均血紅蛋白佔有率超過 41%並通過更高的維持劑量改善紅細胞健康。維持劑量耐受性良好。

We believe these results may be transformative for patients, with a potential to achieve 35% to 45% hemoglobin occupancy, which is considered optimal for both hemoglobin oxygen affinity and preventing sickling, and approaches levels seen with gene therapy. This asset is also being studied in an ongoing Phase II study with a seamless Phase II/III design. We plan to start the Phase III part in the second half of 2023.

我們相信這些結果可能對患者俱有變革性，有可能實現 35% 至 45% 的血紅蛋白佔有率，這被認為是血紅蛋白氧親和力和預防鐮狀化的最佳選擇，並接近基因治療所見的水平。該資產也在正在進行的 II 期研究中進行研究，該研究具有無縫的 II / III 期設計。我們計劃在 2023 年下半年啟動 III 期部分。

Next, we aim to expand our leadership in breast cancer with a pipeline of complementary next-wave candidate. Our CDK4 inhibitor targets improving on CDK4/6 inhibition standard of care by maximizing CDK4 coverage. We're studying it in Phase I in hormone receptor-positive, HER2-negative metastatic breast cancer as a single agent and in combination with endocrine therapy. The majority of hormone receptor-positive breast cancers express low CDK6, while CDK4 is likely to be a major cell cycle driver. We have seen that CDK4/6 inhibition can lead to neutropenia that requires more frequent blood test monitoring, mostly driven by CDK6 inhibition, and that complete CDK4 inhibition by these inhibitors is challenging due to dose-limiting hematological adverse events.

接下來，我們的目標是通過一系列互補的下一波候選人來擴大我們在乳腺癌領域的領導地位。我們的 CDK4 抑製劑旨在通過最大化 CDK4 覆蓋率來改善 CDK4/6 抑制護理標準。我們正在研究它在激素受體陽性、HER2 陰性轉移性乳腺癌中作為單一藥物並與內分泌治療相結合的 I 期研究。大多數激素受體陽性乳腺癌表達低 CDK6，而 CDK4 可能是主要的細胞週期驅動因素。我們已經看到，CDK4/6 抑制可導致中性粒細胞減少，這需要更頻繁的血液檢測監測，主要由 CDK6 抑制驅動，並且由於劑量限制性血液學不良事件，這些抑製劑完全抑制 CDK4 具有挑戰性。

In the Phase I combination study, the confirmed objective response rate in combination with fulvestrant or letrozole reached nearly 30%. And the clinical benefit rate was approximately 50% in 21 patients with measurable disease. The median progression-free survival was more than 24 weeks in 26 patients, including 5 without measurable disease. All patients were heavily pretreated with a median of 4 lines of prior treatment. All patients received prior CDK4/6 inhibitor treatment and 67% received prior fulvestrant. The asset was well tolerated with the CDK4 drug showing only 15% Grade 3 neutropenia and no Grade 4.

在I期聯合研究中，與氟維司群或來曲唑聯合使用的確認客觀緩解率達到近30%。 21 例可測量疾病患者的臨床獲益率約為 50%。 26 名患者的中位無進展生存期超過 24 週，其中 5 名患者沒有可測量的疾病。所有患者均接受過重度預處理，先前治療的中位數為 4 線。所有患者均接受過 CDK4/6 抑製劑治療，67% 的患者接受過氟維司群治療。該資產耐受性良好，CDK4藥物僅顯示 15% 的 3 級中性粒細胞減少症，沒有 4 級。

Here we show a scan of a patient who achieved partial response and was on treatment for 47 weeks. She had received 6 lines of prior treatment, including CDK4/6 inhibition and fulvestrant. We are currently engaged in dose optimization, enrolling CDK4/6-naïve cohort and planning to start a randomized study in second-line treatment of estrogen receptor-positive, HER2-negative metastatic breast cancer this year. Additional data readouts from our next wave of breast cancer candidates are anticipated in the first half of '23.

在這裡，我們展示了一名獲得部分反應並接受治療 47 週的患者的掃描圖。她之前接受過 6 線治療，包括 CDK4/6 抑制和氟維司群。我們目前正在進行劑量優化，招募 CDK4/6 初治隊列，併計劃在今年開始一項雌激素受體陽性、HER2 陰性轉移性乳腺癌二線治療的隨機研究。預計將在 23 年上半年從我們的下一波乳腺癌候選者中讀取更多數據。

In addition to the assets I spoke about today, we anticipate multiple milestones over the next 18 months. We expect a pivotal IBRANCE readout in hormone receptor-positive, HER2-positive metastatic breast cancer, a pivotal study start for ARV-471 and a Phase II readout for our KAT6 inhibitor. We have achieved incredible advancement in our vaccines portfolio, including candidates that harness our leadership in mRNA with an unprecedented number of milestones expected. In addition to the expected launches shown here, we expect a Phase III data readout from our modRNA flu candidate vaccine and a potential respiratory combination vaccine study start.

除了我今天談到的資產外，我們預計在未來 18 個月內還會有多個里程碑。我們期待激素受體陽性、HER2陽性轉移性乳腺癌的關鍵 IBRANCE 讀數、ARV-471 的關鍵研究開始以及我們的 KAT6 抑製劑的 II 期讀數。我們在疫苗產品組合方面取得了令人難以置信的進步，包括利用我們在 mRNA 領域的領導地位的候選疫苗，預計將達到前所未有的里程碑數量。除了此處顯示的預期發布之外，我們還希望從我們的 modRNA 流感候選疫苗中讀取 III 期數據，並開始一項潛在的呼吸道聯合疫苗研究。

A Phase I/II study of our shingles candidate, the first mRNA-based shingles vaccine program began last week. In Inflammation & Immunology as well as Internal Medicine, key catalysts include potential launches of potential blockbusters, a planned pivotal study start with [interferon beta map] and data readout in metabolic disease.

我們的帶狀皰疹候選藥物的 I/II 期研究是上週開始的第一個基於 mRNA 的帶狀皰疹疫苗項目。在炎症與免疫學以及內科學領域，關鍵催化劑包括潛在重磅炸彈的潛在上市、一項計劃中的關鍵研究從 [干擾素 beta 圖] 開始，以及代謝疾病的數據讀出。

We are also making good progress in our anti-infectives portfolio, including anticipating full approval for PAXLOVID and planned study starts for both our second-generation COVID-19 antiviral candidate, which may have no or limited drug-drug interaction and our RSV antiviral candidate.

我們在抗感染藥物組合方面也取得了良好進展，包括預計 PAXLOVID 將獲得完全批准，併計劃開始對我們的第二代 COVID-19 抗病毒候選藥物（可能沒有或有限的藥物相互作用）和我們的 RSV 抗病毒候選藥物進行研究.

In closing, we are very optimistic about the many transformative catalysts emerging from the pipeline. Pfizer's scientists are working with urgency and commitment to help the most patients as quickly as we can.

最後，我們對管道中出現的許多變革催化劑非常樂觀。輝瑞的科學家們正在緊迫和承諾地工作，以盡快幫助大多數患者。

Thank you. Let me turn it over to Chris to start the Q&A session.

謝謝你。讓我把它交給克里斯開始問答環節。

Thank you, Mikael. Chelsea, why don't you poll for questions, please? We'll take as many questions as time permits, and Investor Relations will be available after the call to answer any detailed questions that we're not able to address on the call itself.

謝謝你，米凱爾。切爾西，你為什麼不投票提問呢？我們將在時間允許的情況下回答盡可能多的問題，投資者關係部將在電話會議結束後回答我們無法在電話會議上解決的任何詳細問題。

(Operator Instructions) And we'll take our first question from Louise Chen with Cantor.

（操作員說明）我們將與 Cantor 一起回答 Louise Chen 的第一個問題。

So first question I have for you is do you expect your COVID/flu combo to be on an mRNA platform? And then I wanted to ask you on this RSV vaccine, there's a few players in the space. And I'm just wondering if you think anybody could potentially get a preferential recommendation from ACIP. Or is that really hard to achieve? And the last question is on your trispecific monoclonal antibody. Is atopic dermatitis still a key focus for you? And if so, are you moving the focus to this monoclonal antibody? Or are you still focused on etrasimod for atopic dermatitis? And also, you had an oral PD -- sorry, a topical PDE4 that was in development.

所以我要問你的第一個問題是，你希望你的 COVID/flu 組合出現在 mRNA 平台上嗎？然後我想問你關於這種 RSV 疫苗的問題，這個領域有一些參與者。我只是想知道您是否認為任何人都可能從 ACIP 獲得優先推薦。還是真的很難達到？最後一個問題是關於你們的三特異性單克隆抗體。特應性皮炎仍然是您關注的重點嗎？如果是這樣，您是否將重點轉移到這種單克隆抗體上？還是您仍然專注於治療特應性皮炎的依曲莫德？而且，你有一個口服 PD——抱歉，一個正在開發中的局部 PDE4。

Thank you, Louise. Clearly, for the ACIP, will depend on the data. And it's difficult now to say if a preferential could be achieved or not. But for both questions, COVID/flu is mRNA; RSV is not, Mikael, and then also what about the trispecific antibodies?

謝謝你，路易絲。顯然，對於 ACIP，將取決於數據。現在很難說能不能實現優惠。但是對於這兩個問題，COVID/flu 都是 mRNA； RSV 不是，Mikael，那麼三特異性抗體又如何呢？

So as Albert spoke about CIBINQO's expansion, we think there's room for many opportunities in atopic dermatitis. We wanted to highlight this as a really novel, pioneering approach to go beyond the current antibodies in atopic dermatitis with potentially many other allergic diseases. But there is room for several products in our pipeline in both oral and topical segment, as we mentioned. So this is an area, I think, we will excel in.

因此，當 Albert 談到 CIBINQO 的擴張時，我們認為特應性皮炎領域有很多機會。我們想強調這是一種真正新穎、開創性的方法，它超越了目前在特應性皮炎中與潛在許多其他過敏性疾病的抗體。但正如我們所提到的，我們在口服和外用領域的管道中都有幾種產品的空間。所以我認為這是一個我們會擅長的領域。

And what about COVID/flu that is mRNA and RSV that it is not an mRNA. How do you think about it?

COVID/flu 是 mRNA，而 RSV 不是 mRNA。你怎麼看？

Well, I think it actually offers an opportunity when you have the breadth to have a pipeline with different platforms. We think that the COVID/flu, which contains 6 components, and we have made a real good progress in enrolling the study and we'll start to share data in the near future has, by itself, of course, a Fast Track forward pending data. But for the use of a potential triple vaccine, rather than adding up more and more mRNA, with the current technology that we have seen, can lead to reactogenicity limitation and less tolerability. We think this flexibility to add on a protein may give you the perfect balance between efficacy and tolerability.

好吧，我認為它實際上提供了一個機會，當你有足夠的廣度來擁有不同平台的管道時。我們認為，包含 6 個組成部分的 COVID/流感，我們在招募研究方面取得了真正的良好進展，我們將在不久的將來開始共享數據，當然，它本身就有一個快速通道待定數據。但是對於潛在的三重疫苗的使用，而不是增加越來越多的 mRNA，使用我們已經看到的當前技術，可能會導致反應原性限制和耐受性降低。我們認為這種添加蛋白質的靈活性可以讓您在功效和耐受性之間取得完美平衡。

Thank you, Mikael. And also to -- as you know, we are mastering multiple technology vaccines, so we are using fit for purpose here. Every time we feel that a technology is appropriate for the problem we're trying to solve, we apply this technology. Flu and COVID, they are -- speed is of essence because there are variants that are coming. So mRNA is ideal position to address this challenge.

謝謝你，米凱爾。而且——正如你所知，我們正在掌握多種技術疫苗，所以我們在這裡使用適合的目的。每當我們覺得某項技術適合我們要解決的問題時，我們就會應用該技術。流感和 COVID，它們是——速度至關重要，因為即將出現變種。因此 mRNA 是應對這一挑戰的理想位置。

With RSV, the virus is not changing that often. So a protein approach that has a brilliant tolerability profile, almost [high placebo was] when we saw the data, the responses of the vaccine arm compared to the placebo arm were very difficult to separate. With very, very high efficacy in our case, I think it's the best way to move forward. That's the benefit of having multiple approaches and multiple technologies.

對於 RSV，病毒不會經常發生變化。因此，當我們看到數據時，一種具有出色耐受性的蛋白質方法幾乎 [高安慰劑]，與安慰劑組相比，疫苗組的反應很難區分。在我們的案例中，效率非常非常高，我認為這是前進的最佳方式。這就是擁有多種方法和多種技術的好處。

Our next question will come from Terence Flynn with Morgan Stanley.

我們的下一個問題將來自摩根士丹利的 Terence Flynn。

Maybe two parts from me. Was just wondering if you can provide any more details on the European vaccine contracts that were extended. Just wondering if you were able to secure a higher average price, given some of the headlines in the press earlier this week. And then latest thinking on PAXLOVID commercial pricing in the U.S. as well. Was wondering if you could weigh in on that. And then the second question relates to economics with BioNTech on a combo vaccine. Just wondering how that will work in the event that you do go forward with a combined COVID and seasonal flu messenger RNA vaccine.

也許是我的兩個部分。只是想知道您是否可以提供有關延長的歐洲疫苗合同的更多詳細信息。考慮到本週早些時候媒體的一些頭條新聞，我只是想知道你們是否能夠獲得更高的平均價格。然後是關於美國 PAXLOVID 商業定價的最新思考。想知道你是否可以權衡一下。然後第二個問題與 BioNTech 在聯合疫苗方面的經濟學有關。只是想知道如果您繼續使用 COVID 和季節性流感信使 RNA 聯合疫苗，這將如何發揮作用。

I'll take the last one and then Angela will answer the European vaccine and the PAXLOVID. As you know, the flu vaccine that we are developing, BioNTech also have an economic position into it. And of course, the COVID vaccine, it is a vaccine that we are sharing with them. So we are not ready to make any comments regarding the economics about the potential COVID and flu vaccine. Angela, what about the European situation and PAXLOVID pricing?

我會拿最後一個，然後安吉拉會回答歐洲疫苗和 PAXLOVID。如您所知，我們正在開發的流感疫苗，BioNTech 也有經濟地位。當然，還有 COVID 疫苗，這是我們與他們分享的疫苗。因此，我們不准備就潛在的 COVID 和流感疫苗的經濟學發表任何評論。安吉拉，歐洲情況和 PAXLOVID 定價如何？

So for COMIRNATY in Europe, as you know, this was a multiyear contract that we entered into with the Commission and the member states. And so I think the pricing there is what it is for the contract, and we're in discussions with the European Commission regarding '23 and what the deliveries will look like. Specifically for PAX, I think that was your next question, that is going commercial only later in this year so we are now preparing what those pricing scenarios could look like, and we'll share more at the right time.

因此，對於歐洲的 COMIRNATY，如您所知，這是我們與委員會和成員國簽訂的多年期合同。因此，我認為那裡的定價是合同的價格，我們正在與歐盟委員會討論 23 年以及交付的情況。特別是對於 PAX，我認為這是你的下一個問題，它只會在今年晚些時候商業化，所以我們現在正在準備這些定價方案可能是什麼樣子，我們會在適當的時候分享更多。

Thank you, Angela. And also to repeat, I think David has mentioned it already that in our guidance for this year, we factor only a portion of the European contract. So we spread the volumes into multiple years, although no agreement has been reached yet.

謝謝你，安吉拉。再重複一遍，我認為大衛已經提到，在我們今年的指導中，我們只考慮了歐洲合同的一部分。因此，我們將這些卷分散到多年，儘管尚未達成任何協議。

Our next question will come from Robyn Karnauskas with Truist.

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

So just to drill down a little bit on PAXLOVID. It looks like IQVIA numbers are implying about 9.3 million versus, say, the 12 million that you mentioned for 2022. So I was wondering if you think about the split going forward ex U.S., could it be somewhat similar? Do you think it'll be more skewed to be more even between the U.S. and ex U.S.? And then my second question is, it also could imply that about half of your 20 million contracts were used in 2022. So how do you think about -- could it be very minimal revenue as you draw down that PAXLOVID and will that go into a stockpile?

因此，只需深入了解 PAXLOVID。看起來 IQVIA 的數字暗示著大約 930 萬，而你提到的 2022 年是 1200 萬。所以我想知道你是否考慮過美國以外的分裂，它是否有點相似？你認為美國和前美國之間會更加傾斜嗎？然後我的第二個問題是，這也可能意味著你的 2000 萬份合同中有大約一半是在 2022 年使用的。那麼你如何看待——當你提取 PAXLOVID 時，收入會不會非常少，並且會進入儲存？

Angela?

安吉拉？

Sure. Well, let's start with the U.S. PAXLOVID. So in 2022, when we launched PAXLOVID, we -- the first quarter of PAXLOVID, the first quarter post launch, we did not really have sufficient supply because we were still ramping up. So the total number of doses that were used in the U.S. for PAXLOVID is actually less than the demand. So that's why you see that we used about 8.6 million, 8.9 million doses in the U.S. when actually demand was much more than that.

當然。好吧，讓我們從美國的PAXLOVID開始吧。因此，在 2022 年，當我們推出 PAXLOVID 時，我們 - PAXLOVID 的第一季度，即推出後的第一季度，我們並沒有真正擁有足夠的供應，因為我們仍在增加。因此，美國用於 PAXLOVID 的總劑量實際上少於需求。所以這就是為什麼你看到我們在美國使用了大約 860 萬、890 萬劑，而實際需求遠不止於此。

Then you asked a question about IQVIA, the difference. As you know, IQVIA doesn't capture all the channels, so you're not going to see an exact match. But I think that in general for 2023, the number of doses that you will see for the U.S. and for ex U.S. is just going to be a function of the contracts that were made, the deliveries that we have to make in each of the countries and also the timing of the commercialization. And it just looks different in every single country.

然後你問了一個關於IQVIA的問題，區別。如您所知，IQVIA 不會捕獲所有頻道，因此您不會看到完全匹配的頻道。但我認為，總的來說，到 2023 年，你將看到美國和美國以外的疫苗接種數量將取決於所簽訂的合同，以及我們必須在每個國家/地區進行的交付以及商業化的時機。它在每個國家看起來都不一樣。

Thank you, Angela. And also to emphasize that the 12 million calculations are a global number, not a U.S. number. It's a global number. So I believe the 9 million of IQVIA is approximately in the U.S. And -- but I don't know if they have also estimations for outside the U.S. The global number exclude -- I'm sorry for the clarification. It's a global number, excluding the 12 million that I mentioned.

謝謝你，安吉拉。並且還要強調一下，1200萬的計算是一個全球數字，不是美國的數字。這是一個全球數字。所以我相信 IQVIA 的 900 萬大約在美國而且 - 但我不知道他們是否也有美國以外的估計。全球數字不包括 - 我很抱歉澄清。這是一個全球數字，不包括我提到的 1200 萬。

Our next question will come from Geoff Meacham with Bank of America.

我們的下一個問題將來自美國銀行的 Geoff Meacham。

Just have two. The first one is on COVID. When you look at the 2023 demand and beyond really for both products, I guess I'm trying to better understand the volume side of the equation. Are you guys baking in the emergence of, say, a new variant or maybe a change in behavior towards boosters? That's the first question.

只要有兩個。第一個是關於 COVID 的。當您查看這兩種產品的 2023 年及以後的實際需求時，我想我正在努力更好地理解等式的數量方面。你們是在烘烤新變體的出現，還是對助推器行為的改變？這是第一個問題。

The second one is, from a BD perspective, Albert, you have a lot of cash to deploy. If your COVID assumptions don't quite play out, does that inform the number of deals or the size of deals? I guess I'm trying to get a view about where BD fits in your strategic priorities.

第二個是，從 BD 的角度來看，Albert，你有很多現金可以部署。如果您的 COVID 假設沒有完全發揮作用，這是否會影響交易數量或交易規模？我想我正在嘗試了解 BD 在您的戰略重點中的位置。

Of course. First, what is the assumption about the disease because that's a fundamental assumption behind all these projections that we are doing. It is that the disease will continue in the foreseeable future, manifesting clinically the same way that it does in the last 6, 9 months. So there will be mutations and there will be infections over there. And -- but the vaccination rates will be coming down because of lack of compliance but will stabilize to a certain degree of people because they believe in vaccinations and they feel they are at high risk and they want to make the vaccines.

當然。首先，關於疾病的假設是什麼，因為這是我們所做的所有這些預測背後的基本假設。而是這種疾病將在可預見的未來繼續存在，臨床表現與過去 6、9 個月相同。所以那裡會有突變，那裡會有感染。並且 - 但由於缺乏合規性，疫苗接種率將會下降，但會在一定程度上穩定下來，因為他們相信疫苗接種並且他們覺得自己處於高風險中並且他們想要製造疫苗。

At the same time, the infections were slightly going up because when you have waning immune protection for the population, then you will see more infections and actually more severe infections. So these are the assumptions that we are using. We are not using assumptions that all the variants we will have will escape the protection of the vaccine. But we are using the assumptions that people will be getting 1.3 in the beginning and then going down 1.1, 1.2 doses per year as a normal booster.

與此同時，感染人數略有上升，因為當你對人群的免疫保護減弱時，你會看到更多的感染，實際上是更嚴重的感染。所以這些是我們正在使用的假設。我們並沒有假設我們將擁有的所有變體都會逃脫疫苗的保護。但我們假設人們在開始時會得到 1.3 劑，然後每年減少 1.1、1.2 劑作為正常的加強劑。

What was the second question? On the BD, yes. Clearly, business development is, by far, one of our biggest priorities, something that I personally take care of and something that we have a very big team screening all the opportunities. I would like to ask Aamir, who is responsible for that area, to make some comments about our priorities.

第二個問題是什麼？在 BD 上，是的。顯然，到目前為止，業務發展是我們最優先考慮的事情之一，這是我個人負責的事情，也是我們有一個非常大的團隊篩選所有機會的事情。我想請負責該領域的 Aamir 就我們的優先事項發表一些意見。

So Geoff, specifically to your question, you heard Albert described, we set this aspiration goal of $25 billion in 2030 from BD, where over 40% of the way there with approximately $10.5 billion of that number through the deals that we've done. And we feel very confident that we've got the financial flexibility on the balance sheet and the firepower to complete what we need to, to achieve that goal. And we're going to continue to be disciplined about how we pursue that.

所以傑夫，特別是你的問題，你聽到阿爾伯特描述過，我們設定了 2030 年 BD 的 250 億美元的宏偉目標，其中超過 40% 的方式是通過我們已經完成的交易實現的，其中大約 105 億美元。我們非常有信心，我們在資產負債表上具有財務靈活性，並且有足夠的火力來完成我們需要做的事情，以實現這一目標。我們將繼續遵守我們如何追求這一目標的紀律。

Our next question will come from Steve Scala with Cowen.

我們的下一個問題將來自 Steve Scala 和 Cowen。

I have a couple of questions. On Page 4 of the release, Pfizer reiterated that non-COVID revenue growth in 2023 will be 7% to 9% and anticipates it will be split between launch, acquired and in-line products. That implies about $3.5 billion in incremental revenue growth. But in 2022, Prevnar alone grew $1 billion, and Eliquis and VYNDAQEL together added another $1 billion.

我有一些問題。在新聞稿的第 4 頁，輝瑞重申 2023 年非 COVID 收入增長將在 7% 至 9% 之間，並預計它將在發布、收購和在線產品之間分配。這意味著大約 35 億美元的增量收入增長。但在 2022 年，僅 Prevnar 一項就增長了 10 億美元，Eliquis 和 VYNDAQEL 一起又增加了 10 億美元。

So with the launch and acquired products growing well, what does this guidance imply for the base business in 2023? It seems like a substantial slowdown is implied in the base business in the current year. Second question, has Pfizer learned anything from the ZEPOSIA performance to date that would either increase or decrease its confidence in etrasimod?

那麼，隨著推出和收購的產品增長良好，該指南對 2023 年的基礎業務意味著什麼？今年的基礎業務似乎暗示著大幅放緩。第二個問題，輝瑞是否從 ZEPOSIA 的表現中學到了任何會增加或減少其對 etrasimod 的信心的東西？

I would say, Dave, do you want to say how it's allocated, the growth between in-line, new products and acquired products?

我會說，戴夫，你想說說它是如何分配的，在線、新產品和收購產品之間的增長嗎？

Yes, a really good question. I think if you look at each one, each of those 3 buckets, we see growth from acquired products, we see acquired from new products. And importantly, we see growth in our in-line portfolio as well. We do not anticipate nor do we see a slowdown from that perspective.

是的，一個非常好的問題。我認為，如果你看看每一個，這 3 個桶中的每一個，我們都會看到收購產品的增長，我們看到新產品的收購。重要的是，我們也看到了在線產品組合的增長。從這個角度來看，我們預計也不會看到經濟放緩。

It's approximately 1/3, 1/3, 1/3. And Angela, what about the etrasimod?

大約是 1/3、1/3、1/3。 Angela，etrasimod 呢？

I think we're really excited about etrasimod as a new entry in UC. It's a market that has been heavily dominated by biologics and then followed by the use of JAKs after the biologics. But really, in the earlier treatment positions, there really hasn't been much innovation, and that's where we see etrasimod fitting in. I think the safety profile of etrasimod and its efficacy allows it to be used very well as an agent prior to the use of biologics. And that's where we see the ability to tap into a new segment and to grow.

我認為我們對 etrasimod 作為 UC 的新成員感到非常興奮。這是一個一直由生物製劑主導的市場，然後在生物製劑之後使用 JAKs。但實際上，在較早的治療位置上，確實沒有太多創新，而這正是我們看到 etrasimod 適合的地方。我認為 etrasimod 的安全性及其功效使其可以很好地用作治療前的藥物使用生物製劑。這就是我們看到進入新細分市場和發展的能力的地方。

And because I'm very excited about the product, William, would you like also to add something about it?

因為我對這個產品感到非常興奮，William，你也想補充一下嗎？

Yes. I would just say we're excited about the best-in-class profile with the study that we did had a treat-through design. We hope and anticipate that we'll have no black box warning. We don't anticipate any requirement for titration. The once-oral dosing, 100% of our patients were in complete remission after a year and we're still -- that were in complete remission after 1 year were steroid-free. And we also have quick lymphocyte recovery after discontinuation. So we feel all of these features potentially make etrasimod a best-in-class profile.

是的。我只想說，我們對通過治療設計進行的研究中的一流概況感到興奮。我們希望並期待我們不會有黑框警告。我們預計不會有任何滴定要求。一次口服給藥後，我們 100% 的患者在一年後完全緩解，而我們仍然 - 1 年後完全緩解且無類固醇。而且我們在停藥後也有快速的淋巴細胞恢復。因此，我們認為所有這些特性都可能使 etrasimod 成為同類最佳的配置文件。

Sure. That's exactly the point. Best-in-class in an area that it is poorly served right now with current solutions, so we see a lot of opportunity.

當然。這就是重點。在當前解決方案服務不佳的領域中處於一流水平，因此我們看到了很多機會。

Our next question will come from Colin Bristow with UBS.

我們的下一個問題將來自瑞銀的 Colin Bristow。

I guess first question on COVID and to sort of piggyback on what Geoff was asking. I mean from your slides and comments, you're clearly expecting a sort of stable vaccine utilization rate when, in the last 12 months, we've seen this number decline on a backdrop of a virus that is evolving to less clinically severe variants. And so what underpins your confidence in these longer-term assumptions?

我想第一個問題是關於 COVID 的，並且有點依賴 Geoff 的要求。我的意思是，從你的幻燈片和評論來看，你顯然期待一種穩定的疫苗使用率，而在過去的 12 個月裡，我們看到這個數字在病毒進化為臨床上不太嚴重的變體的背景下有所下降。那麼，是什麼支撐了您對這些長期假設的信心？

And then also in terms of your COVID '23 guidance, you mentioned you'd guided to a sufficient range of variations in infection rates, et cetera. I was just wondering how much an allowance you've made for the potential timing or reduction in contractual orders as is the current situation with the Brussels negotiation? And then maybe just a quick one on the pipeline DMD. This feels noticeably in the background versus other assets at a similar stage. Just could you update us on your level of enthusiasm and commitment to this program, especially in light of the potential competitor approval in May of this year?

然後就您的 COVID '23 指南而言，您提到您已經指導了足夠範圍的感染率變化，等等。我只是想知道在布魯塞爾談判的當前情況下，您為合同訂單的潛在時間安排或減少做了多少準備？然後也許只是一個快速的管道 DMD。與處於類似階段的其他資產相比，這在背景中感覺很明顯。您能否向我們介紹一下您對該計劃的熱情和承諾，特別是考慮到今年 5 月潛在競爭對手的批准？

Thank you. DMD, Mikael?

謝謝你。 DMD，米凱爾？

We continue to be enthusiastic about gene therapy in DMD. I think we have actually published the strongest data on the 2 drugs with efficacy as well as a lot of biomarkers from our Phase I across a much broader age group than anyone else. And I can't comment when possibly someone else will get it registered, but we expect data readouts within possibly less than a year. And we think that this could be a very important drug. And we will have randomized data, which is not the case for any other application currently to have at that size and scope.

我們繼續對 DMD 的基因治療充滿熱情。我認為我們實際上已經發布了關於這兩種具有療效的藥物以及來自我們第一階段的許多生物標誌物的最強有力的數據，涵蓋的年齡組比其他任何人都要廣泛得多。我無法評論其他人何時可能將其註冊，但我們預計數據讀出時間可能不到一年。我們認為這可能是一種非常重要的藥物。我們將擁有隨機數據，目前任何其他應用程序都沒有這樣的大小和範圍。

As regards the assumptions of our COVID protection vaccines, for example, we are dropping the numbers. So for example, 31% of people receiving a vaccine, that was the actual in '22, we are going to 24%. Then you are reaching a level of really people that they are really committed to the idea of getting vaccinations and they are looked by physicians that don't really believe in the vaccination, the value of vaccinations.

例如，關於我們的 COVID 保護疫苗的假設，我們正在降低數字。因此，例如，31% 的人接種了疫苗，這是 22 年的實際情況，我們將達到 24%。然後你達到了一個真正的人的水平，他們真正致力於接種疫苗的想法，而他們所看到的醫生並不真正相信疫苗接種，也不相信疫苗接種的價值。

We are also dropping the number of doses there. So we'll go to 1.3. And then eventually, as the years progress, the number of doses that people will receive is small. Keep in mind that to get numbers like 1.2, you need a very, very small percent of the population to 2 doses so that you can achieve something like that. Maybe 5% of the population will get a second dose, and then you will go to these numbers, as you will see if you include also primary doses and children.

我們也正在減少那裡的劑量。所以我們將轉到 1.3。然後最終，隨著歲月的流逝，人們接受的劑量會越來越少。請記住，要獲得像 1.2 這樣的數字，您需要非常非常小的人口百分比來接種 2 劑疫苗，這樣您才能達到這樣的效果。可能有 5% 的人會接種第二劑疫苗，然後您會查看這些數字，因為您會看到是否還包括初次接種疫苗和兒童。

So we believe the assumptions are very reasonable with the expectation that COVID will remain as it is right now. So nothing more severe and nothing that will make it less severe, and we take into consideration that the compliance with the recommendation of the health authorities also because of the [fact it will] be less. Clearly, pivotal moment will be the introduction of combination vaccines because the convenience or something like that and the fact that people are presenting themselves to receive flu vaccines, given that a combo vaccine would be in the same injection and will cost 0 co-pay likely will become the choice of many to get this full coverage.

因此，我們認為這些假設是非常合理的，並期望 COVID 將保持現在的狀態。因此，沒有什麼比這更嚴重，也沒有什麼會使它變得不那麼嚴重，我們考慮到遵守衛生當局的建議也是因為 [事實會] 更少。顯然，關鍵時刻將是聯合疫苗的引入，因為方便或類似的東西，以及人們主動接受流感疫苗的事實，因為聯合疫苗將在同一注射中並且可能花費 0 共同支付將成為許多人獲得這種全面覆蓋的選擇。

So we are quite confident on these assumptions. But of course, they are only assumptions. We need to wait and see. The other thing it is on the Europe, you asked a few questions. I know that there are rumors, but I don't think that it is appropriate for us to make any comments while we are in negotiation with our partners in the Commission and with the member states. So we only said that we factor on part of the deliveries in this year instead of all the deliveries because we are in the middle of negotiations, but we can't make other comments.

所以我們對這些假設很有信心。但當然，它們只是假設。我們需要拭目以待。另一件事是關於歐洲，你問了幾個問題。我知道有謠言，但我認為在我們與委員會的合作夥伴和成員國進行談判時，我們不宜發表任何評論。所以我們只是說我們考慮了今年的部分交付而不是所有交付，因為我們正在談判中，但我們不能發表其他評論。

Our next question will come from Trung Huynh with Credit Suisse.

我們的下一個問題將來自瑞士信貸的 Trung Huynh。

It's Trung Huynh from Credit Suisse. I have a quick clarification on COVID and then my question. So just on the clarification in those long-term COVID vaccine and PAX slides. Do you expect any U.S. government sales in '24 and '26? It just looks like commercial sales on your slides. So does that mean Medicaid, Medicare populations are bought at a commercial price? And can you comment on the margin change for the vaccine and PAX as you step up to that commercial price?

我是瑞士信貸的 Trung Huynh。我有一個關於 COVID 的快速澄清，然後是我的問題。所以就在那些長期的 COVID 疫苗和 PAX 幻燈片中進行澄清。您預計美國政府在 24 年和 26 年會有銷售嗎？它看起來就像幻燈片上的商業銷售。那麼這是否意味著醫療補助、醫療保險人口是以商業價格購買的？當你提高到商業價格時，你能評論一下疫苗和 PAX 的利潤變化嗎？

And secondly, just following on from the base business question from Steve. We saw lower revenues ex U.S. for some important base business drugs. So Eliquis was down 19% ex U.S., IBRANCE down minus 22% ex U.S. Prevnar, there was also a decline there. You've noted some product-related issues, but are you seeing anything more broadly in the U.S. which is making it a more difficult environment? And going forward, should we expect more normal levels ex U.S. for these products?

其次，緊接著史蒂夫提出的基本業務問題。我們發現一些重要的基礎藥物在美國以外的收入有所下降。因此，Eliquis 在美國以外下跌了 19%，IBRANCE 在美國以外下跌了 -22% Prevnar，那裡也出現了下跌。您已經註意到一些與產品相關的問題，但您是否在美國看到了更廣泛的問題，這使得環境變得更加困難？展望未來，我們是否應該期待這些產品在美國以外的水平更正常？

A quick one because that's easy. We do not expect '24 and '25 and beyond to have governmental sales in the U.S. In fact, we think that not even this year, other than some small deliveries that we have still pending with the U.S. government from the coronavirus before. We will not see any U.S. purchases. That's our assumption right now, that we will move into a commercial model that will cover all channels as with all other vaccines and products.

一個快速的，因為那很容易。我們預計 24 年和 25 年及以後不會在美國進行政府銷售。事實上，我們認為即使是今年也不會，除了我們之前仍在等待美國政府處理冠狀病毒的一些小額交付。我們不會看到任何美國採購。這是我們現在的假設，我們將進入一種商業模式，該模式將像所有其他疫苗和產品一樣覆蓋所有渠道。

Margin changes, we haven't said anything yet about PAXLOVID so I can't comment, if you can calculate. We set the risk price, you can calculate the net and then you can make your assumptions on margins. We don't give margins on specific programs. Now a little bit on the lower revenues -- about the revenues ex U.S. Angela, do you want to make any comment on that?

保證金變化，我們還沒有說任何關於 PAXLOVID 的事情，所以我不能評論，如果你能計算的話。我們設定風險價格，您可以計算淨值，然後您可以對保證金做出假設。我們不為特定項目提供利潤。現在談談較低的收入——關於美國安吉拉的收入，你想對此發表評論嗎？

Sure. As you said, there were some specific reasons for why we saw what we saw for Eliquis, IBRANCE, PCV. I mean Eliquis specifically was the loss of exclusivity and our patent challenges that led to some generic increase at risk in both the U.K. and Netherlands. I mean IBRANCE is a mature product, and so it goes through sort of the reimbursement and the sort of the pricing regulation that it typically goes through in Europe. And I think PCV in general, what we're seeing is that, at least on the [kids side], not on the adult side but on the kids side , vaccinations are still are not back up to where they are, where it was prior to the pandemic. So I think in all 3 cases, there were very specific reasons for what you saw. And we don't anticipate anything extraordinary or different in 2023. I think it's sort of business as usual.

當然。正如您所說，我們看到 Eliquis、IBRANCE、PCV 的情況有一些具體原因。我的意思是 Eliquis 特別是排他性的喪失和我們的專利挑戰導致英國和荷蘭的仿製藥風險增加。我的意思是 IBRANCE 是一個成熟的產品，因此它經歷了它通常在歐洲經歷的某種報銷和某種定價監管。我認為 PCV 總體而言，我們所看到的是，至少在 [兒童方面]，不是在成人方面，而是在兒童方面，疫苗接種仍然沒有恢復到原來的水平，以前的水平在大流行之前。所以我認為在所有 3 種情況下，您看到的情況都有非常具體的原因。我們預計 2023 年不會有任何特別或不同的事情發生。我認為一切照舊。

Next question will come from Tim Anderson with Wolfe Research.

下一個問題將來自 Wolfe Research 的 Tim Anderson。

I think one of the challenges for analysts modeling Pfizer is to try to understand what the flow-through to profitability is from PAXLOVID and COMIRNATY. So I'm hoping directionally, you can tell us how that looks going forward once you get past this transitional year of '23. So in '24 and beyond, is the profitability of that combined franchise likely to be higher, less or the same as what it was in 2021 and 2022? And then a second question is on SG&A. How much of that increase was driven by inflation in 2023? And just any quick comments on European austerity measures on the pricing.

我認為分析師對輝瑞建模的挑戰之一是試圖了解 PAXLOVID 和 COMIRNATY 對盈利能力的影響。所以我希望方向性地，你可以告訴我們，一旦你度過了 23 年這個過渡年，它會如何發展。那麼在 24 世紀及以後，合併後的特許經營權的盈利能力可能會高於、低於或等於 2021 年和 2022 年的水平嗎？然後第二個問題是關於 SG&A。 2023 年的增長有多少是由通貨膨脹推動的？以及對歐洲定價緊縮措施的任何快速評論。

Dave?

戴夫？

Yes. So on -- maybe on the COVID franchise, obviously, we don't give profitability for each product. But you can imagine, as we stated before, on the vaccine, we split our gross margin with BioNTech. So therefore, that would obviously carry a lower profitability mix compared to a typical product. And PAXLOVID is probably the opposite in the sense that we share that, the economics of that fully. So it's probably a bit on the larger higher-margin side in general. That's...

是的。等等 - 也許在 COVID 特許經營權上，顯然，我們不會為每種產品提供盈利能力。但你可以想像，正如我們之前所說，在疫苗方面，我們與 BioNTech 分享了我們的毛利率。因此，與典型產品相比，這顯然會帶來較低的盈利組合。而 PAXLOVID 可能恰恰相反，因為我們完全認同這一點，完全符合經濟學原理。因此，總的來說，它可能有點偏向於利潤率較高的一面。那是...

And one, you can predict that, for example, in the first years '21, '22 had very high R&D expenses also. We maintain our R&D expenses of COVID. A very big part of our expenses in '23 is for COVID because we are investing. But we expect over time those, unless if we bring new products that will not be as high as. On the contrary, price are going up, that says that margins could improve. But also SI&A, promotion expenses are going up, right? So without wanting to give direction from what it used to be '21, '22, likely, we expect going forward to be higher, the margins. But all of these equations will be in play.

第一，你可以預測，例如，在 21 年和 22 年的頭幾年，研發費用也非常高。我們維持 COVID 的研發費用。我們在 23 年的很大一部分支出用於 COVID，因為我們正在投資。但是我們期望隨著時間的推移，除非我們帶來新產品，否則不會像以前那樣高。相反，價格正在上漲，這表明利潤率可能會提高。而且 SI&A，促銷費用也在上漲，對吧？因此，我們不想從過去的 21 年、22 年給出方向，我們預計未來的利潤率會更高。但所有這些方程式都將發揮作用。

Our next question will come from Mohit Bansal with Wells Fargo.

我們的下一個問題將來自 Wells Fargo 的 Mohit Bansal。

Maybe one question, if I can ask. So regarding the expenses for COVID business, Dave, you mentioned that you will be essentially relaunching these products with the commercial scale and everything. So is there -- so how much cost, given that your COVID business is declining significantly this year, are you modeling any kind of cost cuts in that business? Or should be more on dollar basis are still the same? And is there any synergies you can achieve especially for vaccine with your existing Prevnar business because the channels are similar or not? And last part is, do you think you can do more share buybacks given the stock price at this point?

也許一個問題，如果我可以問的話。因此，關於 COVID 業務的費用，戴夫，你提到你基本上將以商業規模和一切重新推出這些產品。那麼有多少成本，鑑於你的 COVID 業務今年大幅下降，你是否正在為該業務中的任何一種成本削減建模？還是應該更多以美元為基礎還是一樣？由於渠道是否相似，您是否可以與現有的 Prevnar 業務實現任何協同效應，尤其是在疫苗方面？最後一部分是，鑑於目前的股價，您認為您可以進行更多的股票回購嗎？

Let me take the first two quickly. Of course, as you saw, the business is going down. Because of COVID, the average is growing. Expenses are going up because we are promoting new launches, including COVID. So right now, moving into COMIRNATY in commercial and PAXLOVID with the commercial channels, now we treat them like normal promotional products, very sensitive in promotions at the beginning of their launch. So we are going very hard with promotions, TV, field forces and all the other educational measures that we are taking when we do this type of launch. So there is -- clearly this [space]. What about, David, are we going to buy back?

讓我快速拿下前兩個。當然，如您所見，業務正在下滑。由於 COVID，平均值正在增長。費用正在上升，因為我們正在推廣新產品，包括 COVID。所以現在，進入商業渠道的 COMIRNATY 和商業渠道的 PAXLOVID，現在我們將它們視為正常的促銷產品，在它們推出之初就對促銷非常敏感。因此，我們在進行此類發佈時正在採取的促銷、電視、外勤人員和所有其他教育措施方面都非常努力。所以有-- 顯然是這個[空間]。大衛，我們要回購嗎？

Yes. So a really good question. I think as we look at capital allocation at this point in time, we actually see a lot of opportunities to invest back into our business, both from a research perspective and importantly, getting behind our launches to make sure that we're doing all that we can to ensure that our growth trajectory in '25 and '30 and those goals and aspirations become reality. So I think our best and highest use of capital right now is investing in our business, both internally as well as from a BD perspective. I would say never say never to an incremental share repurchase, but that's not high on the priority list at this point.

是的。這是一個非常好的問題。我認為，當我們在這個時間點審視資本配置時，我們實際上看到了很多重新投資我們業務的機會，無論是從研究角度還是重要的是，支持我們的發布以確保我們正在做所有這些我們可以確保我們在 25 世紀和 30 年代的增長軌跡以及那些目標和願望成為現實。所以我認為我們現在最好和最高的資本使用是投資於我們的業務，無論是在內部還是從 BD 的角度。我會說永遠不要說永遠不要增量股票回購，但目前這在優先級列表上並不高。

And Mohit also, you asked also about the synergies, it's clear. There are a lot of synergies right now, both in the PAXLOVID. PAXLOVID is covered by a lot of physicians, and we have very, very strong primary care field force and took a very strong also vaccines field force that is covering all these physicians that are [either vaccinate] or prescribing PAXLOVID. So clearly, a lot of synergies in retail and in the medical profession relationship.

很明顯，Mohit 也問到了協同效應。 PAXLOVID 現在有很多協同作用。 PAXLOVID 被很多醫生覆蓋，我們擁有非常非常強大的初級保健現場力量，並且擁有非常強大的疫苗現場力量，涵蓋所有這些 [接種疫苗] 或開 PAXLOVID 的醫生。很明顯，零售業和醫療行業關係中存在很多協同效應。

Our next question will come from Chris Schott with JPMorgan.

我們的下一個問題將來自摩根大通的 Chris Schott。

Just building on some of the OpEx discussion here. I just want to make sure I'm understanding the OpEx dynamics properly over time. So I guess should we think about 2023 as more of a onetime step-up in OpEx and then much slower growth in '24 and beyond? Or should we be thinking about this as a couple of year process as you really get the pipeline and new products ramped, and then it's maybe more second half of the decade before we think even about margin -- bigger margin expansion or that OpEx slowing? I just want to make sure I'm seeing those dynamics properly.

只是建立在此處的一些 OpEx 討論之上。我只是想確保隨著時間的推移我正確地理解了 OpEx 動態。所以我想我們是否應該將 2023 年更多地視為 OpEx 的一次性提升，然後在 24 年及以後的增長放緩得多？或者我們是否應該將此視為幾年的過程，因為你真的得到了管道和新產品的增加，然後它可能在我們考慮利潤之前的十年下半年 - 更大的利潤擴張或 OpEx 放緩？我只是想確保我正確地看到了這些動態。

And then the second one was on the COVID/flu combination. I guess is your expectation that the tolerability of that will be similar to what we see with COMIRNATY? Or is there some trade-off of we could see maybe slightly higher kind of side effects for the 6 components you mentioned but that's offset by the convenience? I'm just trying to make sure I understand what your expectations are for that program.

然後第二個是關於 COVID/flu 組合。我想您是否期望它的耐受性與我們在 COMIRNATY 中看到的相似？或者是否有一些權衡，我們可以看到您提到的 6 個組件的副作用可能略高，但被便利性所抵消？我只是想確保我了解您對該計劃的期望。

Thank you very much, Chris. To this scientific question, to Mikael first.

非常感謝你，克里斯。對於這個科學問題，首先是 Mikael。

Yes. We think that the tolerability will be well on par with vaccines used in the target population and be perceived as tolerable and convenient. As you described, the combination will attract the high volume of flu people to also be able in one shot to renew their COVID coverage, particularly with more and more variant coming. So we are very positive and think we are right in the balance of those and opportunity there.

是的。我們認為耐受性將與目標人群中使用的疫苗相當，並且被認為是可耐受和方便的。正如您所描述的，這種組合將吸引大量流感患者，他們也能夠一次性更新他們的 COVID 覆蓋範圍，尤其是隨著越來越多的變種出現。所以我們非常積極，認為我們在這些和機會之間取得了平衡。

Thank you. And of course, the data will say, but right now, this is the profile that we are targeting. And we think it's easy to do it with 2 viruses, so to load enough so that you have very good efficacy and good tolerability profile. We believe it will be more [challenging for 3], but of course, needs to be seen. And that's why we believe that [ours would be the] protein and having such a good tolerability profile offers better combination of a triplet, then triple it all with mRNA. Dave, also there was this question that I think you touched upon it earlier in your script about how we see going forward the expenses of SI&A.

謝謝你。當然，數據會說，但現在，這是我們的目標人群。而且我們認為用 2 種病毒很容易做到這一點，所以加載足夠多，這樣你就有很好的療效和良好的耐受性。我們相信它會更具 [challenging for 3]，但當然需要看到。這就是為什麼我們相信 [ours would be the] 蛋白質並且具有如此良好的耐受性可以提供更好的三聯體組合，然後用 mRNA 將其全部三倍化。戴夫，還有一個問題，我認為你早些時候在你的腳本中談到了我們如何看待未來 SI&A 的費用。

Yes. So importantly, 2023, we're seeing a step-up in SI&A and it's really, again, investments around the launches and the products that have been acquired, which we think are really important to really drive growth in the back half of the decade. So we're already focused on that. We do think '23 is probably the big year of step-up from expenses. And then post '23, lease expenses will grow more moderately after that.

是的。因此，重要的是，到 2023 年，我們將看到 SI&A 的發展，這實際上又是圍繞發布和已收購產品的投資，我們認為這對於真正推動本世紀後半期的增長非常重要.所以我們已經專注於此。我們確實認為 23 年可能是支出增加的重要一年。然後在 23 年後，租賃費用將在這之後更加溫和地增長。

Our next question will come from David Risinger with SVB Securities.

我們的下一個問題將來自 SVB Securities 的 David Risinger。

Thanks for all of the additional details that you're providing. So it seems like the 2023 guidance is conservative, which is encouraging. But looking to PAXLOVID longer term on Slide 11, I guess I'm surprised that the percentage of symptomatic patients that you expect to be treated with an oral therapy would almost double from 12% to 22% between '22 and '26, even though the pandemic is being viewed as being over. So I'm hoping that you could talk a little bit about those assumptions and what the denominator is. So when you say symptomatic patients, is that high-risk/elderly that you're calculating the 12% on going to 22%, et cetera?

感謝您提供的所有其他詳細信息。因此，2023 年的指導方針似乎是保守的，這令人鼓舞。但是從幻燈片 11 上的 PAXLOVID 長期來看，我想我很驚訝你期望接受口服治療的有症狀患者的百分比在 22 年和 26 年之間幾乎翻了一番，從 12% 到 22%，儘管人們認為大流行病已經結束。所以我希望你能談談這些假設和分母是什麼。所以當你說有症狀的病人時，你計算的是 12% 到 22% 等等的高風險/老年人嗎？

And then in terms of the PAXLOVID share, it was approaching 91% at the year-end of '22, according to this slide, but only declining to 80% in '26 when there are several companies, both large and small, ranging from Gilead to smaller companies that are planning to develop agents to compete aggressively, and that could have implications for both volume and pricing longer term. So wanted to understand that.

然後就 PAXLOVID 份額而言，根據這張幻燈片，它在 22 年底接近 91%，但在 26 年只有幾家公司（無論大小）下降到 80%，範圍從吉利德適用於計劃開發代理以積極競爭的小公司，這可能對銷量和定價產生長期影響。所以想明白這一點。

David, very good question. So let me try to explain a little bit. First of all, it's not 12% going to 22%. It's really 17% going to 22%, right? The 12% which is in '22, it is a partial year, so it didn't include the full year. The real demand, it is, let's say, '23 full year, it is 17%. And it's going up because of two factors: one, it is a small increase in infections. And as I explained, the assumption is that COVID will not disappear, will be there. But vaccine rates, vaccinations are going down. So that will create -- will wane the protection, the new protection of the population. And that will manifest with a small increase, which you factor at 2% based on our modeling, a small increase of both the infections and I mentioned also the severity. So that's one.

大衛，很好的問題。所以讓我試著解釋一下。首先，它不是 12% 到 22%。真的是 17% 到 22%，對吧？ 22 年的 12% 是部分年份，因此不包括全年。真正的需求，比方說，'23 全年，它是 17%。它的上升有兩個因素：第一，感染人數略有增加。正如我所解釋的，假設 COVID 不會消失，而是會存在。但是疫苗接種率和疫苗接種率正在下降。因此，這將創造 - 將削弱保護，對人口的新保護。這將表現為小幅增加，根據我們的模型，你考慮了 2%，感染和我提到的嚴重程度都有小幅增加。這就是一個。

So the second is that the more introductions of new entries likely will not happen before '25, '24, '25, in the U.S. at least. Will depend if EUA will still be available, which will depend if we will be in a state of emergency or not for EUA. But if we will not be in a state of emergency, which could be likely the scenario, there will be no EUAs, and we don't see in '24 any introduction, actually we see in '25 the introductions. The introductions though, also, as always, are increasing the overall cost share, so that is what also is driving. We are dropping market share but we are increasing the volume.

因此，第二個是，至少在美國，可能不會在 25 年、24 年、25 年之前引入更多新條目。將取決於 EUA 是否仍然可用，這將取決於我們是否處於 EUA 緊急狀態。但是，如果我們不會處於緊急狀態（這很可能是這種情況），那麼就不會有 EUA，我們在 24 年也看不到任何介紹，實際上我們在 25 年看到了介紹。不過，這些介紹也一如既往地增加了總體成本份額，因此這也是推動因素。我們正在降低市場份額，但我們正在增加銷量。

The last is are we dropping the market share aggressively enough or are we, let's say, very optimistic in dropping. The assumption here it is that we are the only one which have right now, for years, presence in the market with a label that is extremely strong with 86% clinical efficacy against hospitalization and against death, high actual against death. So it's very difficult for anyone to reproduce this data right now. The studies will run forever likely and will be very large. So very, very difficult to reproduce something like that.

最後一個是我們是否足夠積極地降低市場份額，或者我們是否對下降非常樂觀。這裡的假設是，多年來，我們是唯一一家在市場上佔有一席之地的公司，其標籤非常強大，針對住院和死亡的臨床療效為 86%，實際針對死亡的療效很高。所以現在任何人都很難重現這些數據。這些研究可能會永遠進行下去，而且規模會很大。非常非常難以重現這樣的東西。

So as a result, given that for years, we will be among -- we will be basically the lion market share, plus the excellent profile, the loyalty that will be developed. All of that are telling us that it is very reasonable with -- to maintain very high market share into (inaudible), in first in class. And it's in every treatment, from cancer to that compared to the second and third, it's easy to maintain 60%, 70% of their overall conditions. Now that we have all these advantages, we think maintaining at 70%, 75% I think is reasonable. Of course, we'll have to see.

因此，結果是，多年來，我們將處於 - 我們基本上將佔據最大的市場份額，再加上出色的形象，以及將要培養的忠誠度。所有這些都告訴我們，保持非常高的市場份額（聽不清）是非常合理的，處於一流水平。而且它在每一次治療中，從癌症到第二個和第三個相比，很容易保持他們整體狀況的60%、70%。現在我們有所有這些優勢，我們認為保持在70%，我認為75%是合理的。當然，我們必須拭目以待。

Our next question will come from Chris Shibutani with Goldman Sachs.

我們的下一個問題將來自高盛的 Chris Shibutani。

Two questions. One on PAXLOVID cross-currents there between China in terms of the millions of doses that you described for your first fiscal quarter and a potential transition into a private market in China. And then the U.S. where a similar transition will occur to the commercial. Can you help at all frame what you think the relative contributions could look like in '23 and how that could progress?

兩個問題。一個關於 PAXLOVID 的交叉流在中國之間就您描述的第一財季的數百萬劑量而言，並可能過渡到中國的私人市場。然後是美國，商業廣告也會發生類似的轉變。您能否幫助構建您認為 23 年相對貢獻的樣子以及如何取得進展？

And then in particular with regard to the transition to commercial markets for the COVID franchise products, can you share any early color on the discussions or engagement that you're having with payers? What kind of dynamics? Any color there would be helpful, particularly in the broader context of a global pharmaceutical opportunity with many different therapeutics that will be on their list of budget items, obesity, Alzheimer's, et cetera. So any color on the discussions with payers would be helpful.

然後特別是關於 COVID 特許經營產品向商業市場的過渡，您能否分享您與付款人進行的討論或參與的任何早期色彩？什麼樣的動態？那裡的任何顏色都會有所幫助，特別是在更廣泛的全球製藥機會背景下，許多不同的治療方法將列入他們的預算項目、肥胖症、阿爾茨海默氏症等。因此，與付款人討論的任何顏色都會有所幫助。

Yes. Thank you. Angela?

是的。謝謝你。安吉拉？

Sure. So I think for PAXLOVID, again, the time period, the way to think about it is in 2 time periods from now until April, which is a reimbursed market, which gives us access to both public as well as private channels. And then after April, private channels only. As you heard, we have included in our guidance what we believe we can do in the first 3 months of this year. But given the fact that the back half of the year, we will -- it's going to be highly uncertain. It will be a very dynamic market. We'll continue to make sure that we have supply, but we'll have to just wait and see what happens there.

當然。所以我認為對於 PAXLOVID，時間段，思考它的方式是從現在到 4 月的兩個時間段，這是一個報銷市場，這讓我們可以訪問公共和私人渠道。然後在四月之後，僅限私人頻道。正如您所聽到的，我們已將我們認為在今年前 3 個月可以做的事情納入我們的指南。但考慮到今年下半年的事實，我們將 - 這將是高度不確定的。這將是一個充滿活力的市場。我們將繼續確保我們有供應，但我們必須等待，看看那裡會發生什麼。

On the side of...

在...的一邊

U.S.

我們。

U.S., similarly, we will be transitioning this year. We will have a year where some of the revenue will be made through the completion of contracts that we made with the U.S. government in 2022. And then part of the year, the revenues will come from the commercialization of PAXLOVID. So you're going to see that play through -- both of those dynamics play through. And then I think you had one more question.

美國，同樣，我們將在今年進行轉型。我們將有一年通過完成我們在 2022 年與美國政府簽訂的合同來獲得部分收入。然後在這一年的一部分時間裡，收入將來自 PAXLOVID 的商業化。所以你會看到這一切——這兩種動力都會發揮作用。然後我想你還有一個問題。

Yes, the payers. What is the reaction with the vaccine or...

是的，付款人。疫苗有什麼反應或...

Yes. Yes. So it's still early days, especially in the U.S., right, because that's only happening middle of the year. But what I can say is that we have had some early discussions already with agencies and reimbursement agencies outside of the U.S. who have given us, I guess, earlier feedback. And even if you take a country like the U.K., we actually had very favorable feedback on the pricing that we provided, and they agreed with the cost effectiveness of our PAXLOVID. So I think we'll -- obviously, that's good feedback, and we'll be taking those learnings and those value arguments to multiple countries around the world.

是的。是的。所以現在還為時尚早，尤其是在美國，對吧，因為這只是在年中發生。但我能說的是，我們已經與美國以外的機構和報銷機構進行了一些早期討論，我猜他們給了我們更早的反饋。即使你拿英國這樣的國家來說，我們實際上對我們提供的定價也有非常有利的反饋，他們同意我們 PAXLOVID 的成本效益。所以我認為我們會 - 顯然，這是很好的反饋，我們將把這些知識和價值論據帶到世界各地的多個國家。

Our next question will come from Carter Gould with Barclays.

我們的下一個問題將來自巴克萊銀行的卡特古爾德。

And David, thank you for all the transparency on the underlying assumptions. I guess two from me. First off, just in terms of the upcoming, I guess, messaging around the end of the public health emergency. Can you talk about the potential impact you see on your EUAs, access as well, specifically thinking about PAXLOVID populations in this period before we switch to a commercial market where you're still -- the government is still, I guess, working through the inventory they have in hand?

大衛，感謝您對基本假設的所有透明度。我想我有兩個。首先，就即將到來的，我想，關於公共衛生緊急情況結束的信息。你能談談你看到的對你的 EUA 的潛在影響，以及訪問，特別是在我們轉向商業市場之前考慮這一時期的 PAXLOVID 人口，你仍然 - 我猜政府仍在努力通過他們手頭有存貨嗎？

And then going to the COVID/flu combination, just trying to better understand some of your assumptions here. Because I guess when we think about that '26 40% adoption number, it's some -- I guess, either the incremental bump from 24%, 15% or the 40% absolute, just kind of what that implies about how you think the underlying flu market will change. So I guess that comply 30% to 80% share within 2 years, but just wanted to understand kind of the underlying drivers there and how you think about that market evolving.

然後轉到 COVID/flu 組合，只是想更好地理解您在這裡的一些假設。因為我想當我們考慮 26 年 40% 的採用率數字時，它是一些——我想，無論是從 24%、15% 還是 40% 的絕對增長，這都暗示了你如何看待潛在的流感市場將發生變化。所以我猜想在 2 年內遵守 30% 到 80% 的份額，但只是想了解那裡的潛在驅動因素以及你如何看待這個市場的發展。

Thank you. Maybe I'll try myself quickly because we're running out of time. If there is an end of emergency, we don't think that will have any impact on current EUAs, won't have an impact on issuing new EUAs. I don't think that anything changes in the way that -- emergency or not, whether the inventories will be managed or the access that patients will have in any of these treatments.

謝謝你。也許我會盡快嘗試一下，因為我們的時間不多了。如果緊急狀態結束，我們認為這不會對當前的 EUA 產生任何影響，也不會對發布新的 EUA 產生影響。我認為這種方式不會有任何改變——緊急與否，無論是管理庫存還是患者在任何這些治療中的使用。

Now as regards to COVID/flu, if the introduction of combination for products would change the flu market, I think, yes. Well, would say it's a major flu market was always a single market until now. And suddenly, there is a chance that other respiratory diseases like COVID or RSV will come. So I think that would change. And now the step-up, it is clear we expect that around 24%, 25%, it is a population in the U.S., that believes needs protection and is diligent enough -- not believes, more belief, but they are diligent enough to follow the recommendation and go and get their annual booster for COVID.

現在關於 COVID/流感，如果產品組合的引入會改變流感市場，我認為是的。好吧，可以說這是一個主要的流感市場，直到現在一直是一個單一的市場。突然之間，可能會出現其他呼吸道疾病，如 COVID 或 RSV。所以我認為這會改變。現在升級，很明顯我們預計大約有 24%、25% 是美國人口，他們認為需要保護並且足夠勤奮——不是相信，更多的是相信，但他們足夠勤奮以遵循建議，去獲得他們的 COVID 年度助推器。

When they will present themselves -- excuse me, when the flu people will present themselves and they will be asked the question, if you want flu single or flu with a combo, and they will be given the information that will protect them in a single injection at the same time, 0 co-pay for COVID as well, we believe it's reasonable to expect that the 25% stable will become 30%, so will add another 5% of the population. And that over time, that will move closer to the 50%. We projected 40% over there. So those are the assumptions that we're using.

他們什麼時候出現——對不起，當流感患者出現時，他們會被問到一個問題，如果你想要單獨的流感或組合流感，他們將獲得將在單一流感中保護他們的信息同時注射，0 共同支付 COVID，我們認為可以合理預期 25% 穩定將變為 30%，因此將增加另外 5% 的人口。隨著時間的推移，這將接近 50%。我們預計那裡有 40%。所以這些是我們正在使用的假設。

Our next question will come from Kerry Holford with Berenberg.

我們的下一個問題將來自 Kerry Holford 和 Berenberg。

A couple of questions on vaccines, please. Firstly, on RSV, can you confirm you're on track to provide that second season of data ahead of approval and reimbursement discussions in May-June for the older adult vaccine? And can you confirm whether you've now filed your maternal RSV vaccine with the regulator? If not, are you waiting for the approval in the older adult setting first? And then just on the flu/COVID combo, if we assume you have positive flu Phase III data in the second half of the year, positive Phase I combo data in the first half, would you expect to move the combo into Phase III? Or is there a possibility you will not need a full Phase III combo study to proceed to filing an approval?

請教幾個關於疫苗的問題。首先，關於 RSV，您能否確認您是否按計劃在 5 月至 6 月針對老年人疫苗的批准和報銷討論之前提供第二季數據？您能否確認您現在是否已向監管機構提交了母體 RSV 疫苗？如果沒有，您是否先在老年人環境中等待批准？然後就流感/ COVID 組合而言，如果我們假設你在今年下半年有積極的流感 III 期數據，在上半年有積極的 I 期組合數據，你會期望將組合轉移到 III 期嗎？或者您是否有可能不需要完整的 III 期組合研究來繼續提交批准？

Mikael?

米凱爾？

Yes. I mean we always follow multiseasonal vaccines, and we'll share the second season data as soon as it's available. Of course, there are many ways this can play out with combination vaccines and which could lead to more regular vaccination rather than protracted. And on -- you also asked about the, let's see, the flu/COVID combo here.

是的。我的意思是我們始終關注多季疫苗，我們會在第二季數據可用後立即分享。當然，有很多方法可以通過聯合疫苗發揮作用，這可能會導致更定期的疫苗接種而不是拖延。還有——你還問了，讓我們看看，這裡的流感/ COVID 組合。

Will we need a full Phase III trial or...

我們需要進行完整的 III 期試驗還是……

Yes.

是的。

So if we need a full Phase III, if we have both flu and COVID.

因此，如果我們同時患有流感和 COVID，那麼如果我們需要完整的 III 期。

We expect that you need a Phase III that is based on immunicity and safety and not a large lone trial based on events. So we think we can complete that fast. And if anyone can do it first, it's we. So that's very high on our list currently pending data to move with light speed.

我們希望您需要基於免疫性和安全性的 III 期試驗，而不是基於事件的大型單獨試驗。所以我們認為我們可以很快完成。如果有人能率先做到這一點，那就是我們。因此，在我們的列表中，這是非常高的當前待定數據以光速移動。

Right. And there was a question on reinvestment of Pfizer, Chris, I think.

正確的。還有一個關于輝瑞再投資的問題，克里斯，我想。

Yes. I think, Kerry, you asked if the second season durability data, how that will impact reimbursement discussions, so if we submitted [mature].

是的。我想，克里，你問過第二季的耐久性數據，這將如何影響報銷討論，所以如果我們提交[成熟]。

Yes. I think it will impact ACIP recommendation in vaccines. Once you have ACIP recommendation or not, you're getting automatic actions with all formularies without co-pay. So that, I think it will be the key what ACIP will say.

是的。我認為這會影響疫苗中的 ACIP 推薦。無論您是否有 ACIP 推薦，您都將獲得所有處方集的自動操作，無需共同支付。因此，我認為這將是 ACIP 會說什麼的關鍵。

Our next question will come from Andrew Baum with Citi.

我們的下一個問題將來自花旗銀行的 Andrew Baum。

On PAXLOVID, following commercial approval and the withdrawal of the EUA, will pharmacist prescribing remain intact? And then a couple for Mikael. Could you just explain the reasons for the out-licensing of the TL1A inhibitor to Roivant? I apologize if I missed it. And then second, in relation to your multispecific antibodies or trispecifics, this has been tried previously. I think AbbVie and J&J previously tried in RA and I think in psoriasis with TNF IL-17, but they ran into an issue with binding affinity and they didn't have efficacy. Do you think you've managed to solve the issue here?

在 PAXLOVID 上，在商業批准和 EUA 撤回後，藥劑師處方是否會保持不變？然後是 Mikael 的一對。您能否解釋一下將 TL1A 抑製劑授權給 Roivant 的原因？如果我錯過了，我深表歉意。其次，關於你的多特異性抗體或三特異性抗體，這之前已經嘗試過。我認為 AbbVie 和 J&J 之前曾在 RA 中嘗試過，我認為在牛皮癬中使用 TNF IL-17，但他們遇到了結合親和力的問題，並且沒有療效。你認為你已經設法解決了這裡的問題嗎？

Andrew, the first one is simple, I don't know, in the pharmacist group. It's very likely, I think. But I don't know, we don't have it in our assumptions right now. And let's go to Mikael.

安德魯，第一個很簡單，我不知道，在藥劑師組。我認為這很有可能。但我不知道，我們現在的假設中沒有它。讓我們去找Mikael。

I'll start with, Andrew, great question. You touched my heart today. We have cracked it. These antibodies that I shared today have, first of all, pharmacokinetics like an excellent single antibody but 3-in-1 product and have very high potency, which you asked about, actually exceeding the marketed product substantially. So we think it's really something that we will move very quickly as we learn more of it.

首先，安德魯，很好的問題。你今天觸動了我的心。我們已經破解了它。我今天分享的這些抗體，首先藥代動力學像一個優秀的單抗，但是三合一的產品，而且有非常高的效力，你問的，實際上大大超過了市售產品。所以我們認為，隨著我們對它的了解越來越多，我們會很快採取行動。

And you asked about TL1A. We think we have a very good partnership with Roivant that helps us to do more things within our pipeline. And you have heard Aamir Malik earlier alluded to that we have commercialization rights ex U.S., Japan. We have about half of the value of this product. And we have a follow-on bispecific TL1A [before that sets a] active mechanism STELARA. So we think we have such a richness in this space and really enjoy to build the ecosystem with others and maximize what we bring to patients.

你問了 TL1A。我們認為我們與 Roivant 建立了非常良好的合作夥伴關係，這有助於我們在我們的管道中做更多的事情。你聽說過 Aamir Malik 早些時候提到我們擁有美國和日本以外的商業化權利。我們擁有該產品大約一半的價值。我們有一個後續的雙特異性 TL1A [在此之前設置] 主動機制 STELARA。因此，我們認為我們在這個領域擁有如此豐富的資源，並且非常樂於與他人建立生態系統並最大限度地為患者帶來好處。

Aamir, you want to add something here?

阿米爾，你想在這裡添加一些東西嗎？

The only quick thing I will add, Andrew, is if you look at how prolific our R&D engine has been, the total funding demand from all of the R&D programs that were generated would significantly exceed what we guided to as our R&D spending in '22 and '23. So in that context, we are going to be very thoughtful about how we prioritize. We have a robust process for that.

安德魯，我要補充的唯一一點是，如果你看看我們的研發引擎有多產，產生的所有研發項目的總資金需求將大大超過我們在 22 年指導的研發支出和'23。因此，在這種情況下，我們將非常仔細地考慮我們如何確定優先順序。為此，我們有一個穩健的流程。

And consequently, from time to time, you're going to see programs like the TL1A that have very clear scientific merit, but we think we're sharing the cost, the risk and capabilities with the partner is the best way to create value. And that's what we did in that situation. And we've had a long history of doing that in a number of other situations as well.

因此，您會時不時地看到像 TL1A 這樣具有非常明確的科學價值的項目，但我們認為我們與合作夥伴分擔成本、風險和能力是創造價值的最佳方式。這就是我們在那種情況下所做的。我們在許多其他情況下也有這樣做的悠久歷史。

Our last question will come from Evan Seigerman with BMO.

我們的最後一個問題將來自 BMO 的 Evan Seigerman。

And I'm not going to ask a COVID question because I think they were all asked. So just looking at business development, when you did Biohaven, what were some of the characteristics of the deal that you want to bring forward in kind of your go-forward approach for BD? How should we think about potential holes in your pipeline that you could fill with external deals?

而且我不會問 COVID 問題，因為我認為他們都被問到了。所以只看業務發展，當你做 Biohaven 時，你想在 BD 的前進方法中提出哪些交易特徵？我們應該如何考慮您可以通過外部交易填補您的管道中的潛在漏洞？

Aamir, why don't you take this one?

阿米爾，你為什麼不拿這個？

Sure. The Biohaven deal for us represented an excellent opportunity to leverage our capabilities. And specifically, where were capabilities in terms of our global commercial footprint, that Biohaven as a company alone could not maximize but where application of those capabilities could take Nurtec and the follow-on product to places and reach us for patients that they couldn't have gotten to alone. And also the way in which we structured that transaction, began with an ex U.S. partnership, which we then expanded to take on this full global CGRP franchise and also excluded some assets that were less relevant to us strategically that created a newco.

當然。 Biohaven 交易對我們來說是一個利用我們能力的絕佳機會。具體來說，就我們的全球商業足跡而言，Biohaven 作為一家公司單獨無法最大化的能力在哪裡，但這些能力的應用可以將 Nurtec 和後續產品帶到他們無法到達的地方並為患者提供幫助已經獨自一人了。以及我們構建該交易的方式，從前美國的合作夥伴關係開始，然後我們將其擴展到獲得這個完整的全球 CGRP 特許經營權，並且還排除了一些與我們在戰略上不太相關的資產，這些資產創建了一個新公司。

And I think what you can take away from that is that we're going to continue to look for things that are scientific breakthroughs where we can add capabilities, and we're also going to be creative and disciplined about how we structure our deals. And we think that's going to serve us well as we complete our ambition against our $25 billion goal.

我認為你可以從中得到的是，我們將繼續尋找科學突破的東西，我們可以在其中增加能力，我們也將在如何構建交易方面具有創造性和紀律性。我們認為這將有助於我們實現 250 億美元的目標。

Thank you, Aamir. So thank you, operator. In summary, let me close by saying, first of all, I feel extremely proud for the team in Pfizer that was able to deliver, break all records in 2022, the highest-ever revenue, the highest-ever profits, the highest, more important ever number of patients that we protected or treated with our medicines, the best-ever reputation for our company, the most productive wave of R&D with 18 -- 19 products launching in the next 18 months, the best R&D machine in terms of multiple measures. All of that, we're able to achieve in 2022.

謝謝你，阿米爾。所以謝謝你，運營商。總而言之，讓我最後說，首先，我為輝瑞的團隊感到非常自豪，他們能夠在 2022 年打破所有記錄，創下有史以來最高的收入，有史以來最高的利潤，最高，更多我們用我們的藥物保護或治療的患者人數有史以來最重要，我們公司有史以來最好的聲譽，最有成效的研發浪潮，在接下來的 18 個月內推出 18 至 19 種產品，就多項式而言是最好的研發機器措施。所有這些，我們都能夠在 2022 年實現。

Clearly though, I believe that the best years of Pfizer are ahead because we are building on a significant capital position, but we know how to deploy to create growth. We are building on an R&D engine, that it is more productive than ever in the history of this company. A manufacturing engine that it is the envy of the industry. A commercial envy -- a commercial engine that it is around again and again and again as the best commercial engine in the industry.

但很明顯，我相信輝瑞最好的幾年已經到來，因為我們正在建立重要的資本地位，但我們知道如何部署以創造增長。我們正在建立一個研發引擎，它比這家公司歷史上的任何時候都更有效率。一台令業界羨慕的製造引擎。令人羨慕的商業引擎——一個商業引擎，它一次又一次地成為業內最好的商業引擎。

And, of course, a mindset in Pfizer that is characterized but nothing is impossible. We can make everything possible. So with that in mind, I think that we are moving ahead, hopefully, to an even more successful 2023. Thank you very much for your attention, your interest in us and your support as shareholders.

當然，輝瑞的思維定式是有特色的，但沒有什麼是不可能的。我們可以讓一切成為可能。因此，考慮到這一點，我認為我們正在向前邁進，希望 2023 年更加成功。非常感謝您的關注、您對我們的興趣以及您作為股東的支持。

Thank you, ladies and gentlemen. This does conclude Pfizer's Fourth Quarter 2022 Earnings Conference Call. We appreciate your participation, and you may disconnect your line at any time.

謝謝你們，女士們，先生們。這確實結束了輝瑞公司 2022 年第四季度的收益電話會議。感謝您的參與，您可以隨時斷開您的線路。