輝瑞 (PFE) 2023 Q1 法說會逐字稿

Good day, everyone, and welcome to Pfizer's First Quarter 2023 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chris Stevo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.

大家好，歡迎參加輝瑞 2023 年第一季財報電話會議。今天的通話正在錄音。現在，我想將電話轉給資深副總裁兼首席投資者關係長 Chris Stevo 先生。先生，請繼續。

Thank you, Chelsea. Good morning, everyone. Welcome to Pfizer's first 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.

謝謝你，切爾西。大家早安。歡迎參加輝瑞第一季財報電話會議。今天與我一起出席的還有我們的董事長兼執行長 Albert Bourla 博士；我們的財務長 Dave Denton；以及全球研發和醫療總裁 Mikael Dolsten 博士。

Joining for the Q&A session, we will also have Angela Hwang, Chief Commercial Officer and President, Global Biopharmaceuticals business; Aamir Malik, our Chief Business Innovation Officer; Dr. William Pao, our Chief Development Officer; and Doug Lankler, our General Counsel.

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；我們的首席商業創新官 Aamir Malik；我們的首席開發官 William Pao 博士；以及我們的總法律顧問Doug Lankler。

Before we begin the call, I wanted to remind you of some logistical items. The materials for this call and other earnings-related materials on the Investor Relations section of pfizer.com. Please see our forward-looking statements disclaimer on Slide 3. Additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and our SEC Forms 10-K and 10-Q under Risk Factors and forward-looking information and factors that may affect future results. Forward-looking statements on the call are subject to substantial risks and uncertainties speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements. With that, I'll turn the call over to Albert.

在我們開始通話之前，我想提醒您一些後勤事項。本次電話會議的資料及其他收益相關資料均載於 pfizer.com 的投資者關係部分。請參閱投影片 3 上的前瞻性聲明免責聲明。有關這些聲明和非 GAAP 財務指標的更多信息，請參閱我們的收益報告和 SEC 表格 10-K 和 10-Q，位於“風險因素”和“可能影響未來結果的前瞻性信息和因素”下。電話會議中的前瞻性陳述受重大風險和不確定性的影響，僅代表電話會議最初日期的觀點，我們不承擔更新或修改任何這些陳述的義務。說完這些，我將把電話轉給阿爾伯特。

Thank you, Chris. Hello, everyone, and thank you for joining us today. Q1 was a solid, foundational quarter in what we expect to be an exciting year for Pfizer and patients. Our financial results were as we anticipated. Our non-COVID revenues grew 5% operationally compared with the year-ago quarter, while overall revenues declined 26% operationally primarily due to a previously communicated and expected decline in Comirnaty revenues. Even with Comirnaty's decline, our COVID franchises remained significant contributor to the business with a combined $7.1 billion in revenues during the quarter. This growth was driven primarily by recently acquired products, Nurtec for migraine and Oxbryta for sickle cell disease, our anti-infective Sulperazon, Eliquis, in the non-valvular atrial fibrillation indication in the U.S., and our Vyndaqel family of products for the treatment of transthyretin amyloid cardiomyopathy.

謝謝你，克里斯。大家好，感謝大家今天加入我們。第一季是一個堅實的基礎性季度，我們預計這對輝瑞和患者來說將是令人興奮的一年。我們的財務結果正如我們所預期的。與去年同期相比，我們的非 COVID 營運收入成長了 5%，而整體營運收入下降了 26%，這主要是由於先前溝通過的和預期的 Comirnaty 收入下降。即使 Comirnaty 的業績下滑，我們的 COVID 特許經營權仍然是業務的重要貢獻者，本季總收入達 71 億美元。這一增長主要得益於最近收購的產品，用於治療偏頭痛的 Nurtec 和用於治療鐮狀細胞病的 Oxbryta，我們的抗感染藥物 Sulperazon、用於治療美國非瓣膜性心房顫動的 Eliquis，以及用於治療轉甲狀腺素澱粉樣心肌病的 Vyndaqel 系列產品。

We also continue to be proud of our patient impact. During the first quarter, more than 250 million patients were treated with our medicines and vaccines. With this solid start to the year, we remain on track to grow our non-COVID revenues by 7-9% operationally in 2023. That's because the majority of our potential near-term product launches as you can see mapped out on this slide, are expected to occur in the second half of the year, following regulatory approvals where not yet secured. As such, we expect our non-COVID revenues to grow at a faster rate in the second half of the year than in the first.

我們也繼續為我們對患者的影響感到自豪。第一季度，超過2.5億患者接受了我們的藥物和疫苗治療。憑藉今年的良好開局，我們仍有望在 2023 年實現非 COVID 收入 7-9% 的營運成長。這是因為，正如您在這張投影片上看到的，我們大多數潛在的近期產品預計將在下半年推出，儘管尚未獲得監管部門的批准。因此，我們預計下半年非新冠疫情收入的成長速度將快於上半年。

Overall, we are in the midst of an 18-month period in which we expect to launch up to 19 potential new products and indications. Over the first four months of the year, we have made excellent progress toward this goal with the approval of Zavzpret, an expanded indication for Cibinqo to include adolescents, and last week's approval of Prevnar 20 for pediatric use all in the U.S. We also have secured regulatory filing acceptances for elranatamab, for Braftovi and Mektovi for non-small cell lung cancer, and for our RSV maternal vaccine candidate, which if approved would be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months.

總體而言，我們正處於為期 18 個月的時期，預計在此期間將推出多達 19 種潛在的新產品和新適應症。今年前四個月，我們朝著這一目標取得了巨大進展，Zavzpret 在美國獲得批准，Cibinqo 的適應症擴大至青少年，上週 Prevnar 20 獲批用於兒科治療。我們還獲得了 elranatamab、用於治療非小細胞肺癌的 Braftovi 和 Mektovi 以及 RSV 母體候選疫苗的監管備案受理，該候選疫苗若獲批，將成為首個給孕婦接種的疫苗，有助於預防從出生到六個月大的嬰兒 RSV 疾病並發症。

In addition, the U.S. Food & Drug Administration has granted priority review and the European Medicines Agency has accepted our MAA filing for review of Talzenna for use in combination with Xtandi for patients with newly diagnosed metastatic castration-resistant prostate cancer, based on the TALAPRO-2 results.

此外，根據 TALAPRO-2 的結果，美國食品藥物管理局已授予我們優先審查權，歐洲藥品管理局也已接受我們的 MAA 申請，審查 Talzenna 與 Xtandi 聯合用於治療新診斷的轉移性去勢抵抗性前列腺癌患者。

Regarding our COVID-19 franchise, we continue to expect 2023 to be a transitional year as the virus continues to mutate and to remove from advanced purchases under government contracts to more transitional supply arrangements in the commercial model for both Comirnaty and Paxlovid in the U.S. As previously discussed, in 2023 and 2024, we expect vaccine utilization to decline compared with 2022. Then starting in 2025 and continuing in 2026 and beyond, we expect to see an increase in COVID-19 vaccination rates assuming the successful development and approval of various COVID combination vaccines. Outside the U.S., we expect these general trends to be similar with some variations from country to country.

關於我們的 COVID-19 特許經營權，我們繼續預計 2023 年將是一個過渡年，因為病毒將繼續變異，並且在美國，Comirnaty 和 Paxlovid 的商業模式將從政府合約下的提前購買轉變為更具過渡性的供應安排。如前所述，我們預計 2023 年和 2024 年的疫苗使用率將與 2022 年相比下降。然後從 2025 年開始並持續到 2026 年及以後，假設各種 COVID 組合疫苗成功開發和批准，我們預計 COVID-19 疫苗接種率將上升。在美國以外的地區，我們預期這些整體趨勢將是相似的，但各國之間會有一些差異。

Regarding Paxlovid, we continue to expect the government inventory that was built around the world last year to be absorbed by the end of this year. We then expect that in years '24 and beyond, the courses sold and courses used were more closely align. With its robust efficacy, consistent safety profile and potential to help mitigate the burden of COVID-19 on patients and their families, health system and society, Paxlovid is proving to be an important and durable complementary tool to vaccination strategies for the estimated 40% of the global adult population at high risk for progressing to severe disease.

關於 Paxlovid，我們繼續預計去年世界各地建立的政府庫存將在今年年底前被吸收。我們預計，在 24 年及以後，售出的球場和使用的球場將更加緊密地結合在一起。 Paxlovid 具有強大的療效、一致的安全性以及有助於減輕 COVID-19 對患者及其家屬、衛生系統和社會的負擔的潛力，已被證明是對全球約 40% 患有重症高風險的成年人口的疫苗接種策略的重要且持久的補充工具。

Now let's take a look at Pfizer's next potential moonshot, the battle against cancer. Oncology remains a core therapeutic area for Pfizer, and we believe the proposed acquisition of Seagen will enhance our position in this important space. Integration planning is already underway and we continue to expect the deal to close in late 2023 or early 2024, subject to the satisfaction of customary closing conditions. By combining Seagen's category-leading antibody-drug conjugate technology with Pfizer's scale, expertise and capabilities, we believe we can accelerate potential breakthroughs in cancer medicines and introduce new solutions to patients around the world. The potential combined commercial infrastructure for Pfizer and Seagen will be 3x the size of that of Seagen alone in the U.S. and 4, 5x larger globally. As a result, we believe acquiring Seagen could contribute more than $10 billion in 2030 risk-adjusted revenue with potential significant growth beyond 2030.

現在讓我們來看看輝瑞的下一個潛在的登月計畫——對抗癌症。腫瘤學仍然是輝瑞的核心治療領域，我們相信擬議的Seagen收購將增強我們在這一重要領域的地位。整合規劃已經在進行中，我們仍然預期該交易將在 2023 年底或 2024 年初完成，但須滿足慣例成交條件。透過將 Seagen 領先的抗體藥物偶聯技術與輝瑞的規模、專業知識和能力相結合，我們相信可以加速癌症藥物的潛在突破，並為全球患者推出新的解決方案。輝瑞和Seagen的潛在綜合商業基礎設施將是Seagen單獨在美國規模的3倍、在全球規模的4至5倍。因此，我們相信收購 Seagen 可在 2030 年貢獻超過 100 億美元的風險調整後收入，並在 2030 年後實現潛在的顯著成長。

Even with the Seagen deal, given the strength of our balance sheet and cash flows, we continue to have the flexibility to take additional actions to create shareholder value. Dave will provide more details on this during this presentation.

即使與 Seagen 達成了交易，鑑於我們資產負債表和現金流的強勁，我們仍然可以靈活地採取額外行動來創造股東價值。 Dave 將在本次演講中提供更多詳細資訊。

One of the key areas of focus for Pfizer in 2023 is continuing to build trust, which is a key asset for every biopharmaceutical company. Since the beginning of the year, we have received 2 accolades that demonstrate we are doing just that. In February, Pfizer was named to the top 10 of Fortune's Most Admired Companies List for the second year in a row. And in March, Ethisphere recognized Pfizer as one of the world's most ethical companies, also for the second year in a row.

輝瑞 2023 年關注的重點領域之一是繼續建立信任，這對每家生物製藥公司來說都是關鍵資產。自今年年初以來，我們已獲得 2 項榮譽，證明我們正在這樣做。今年 2 月，輝瑞連續第二年躋身《財星》最受讚賞公司榜前十名。今年 3 月，道德村協會將輝瑞評為全球最具商業道德的公司之一，這也是該公司連續第二年獲此殊榮。

At Pfizer, trust is everything. It gives us our license to operate, allows us to attract the best talent and enables us to deliver breakthroughs that change patients' lives.

在輝瑞，信任就是一切。它授予我們經營許可證，使我們能夠吸引最優秀的人才，並使我們能夠取得改變患者生活的突破。

With that, I will turn it over to Dave. After Dave, Mikael will provide an update on R&D pipeline. Dave?

說完這些，我會把麥克風交給戴夫。 Dave 之後，Mikael 將提供有關研發管道的最新進展。戴夫？

Thank you, Albert, and good morning, everyone. I want to begin with Pfizer's capital allocation strategy before we dive into additional commentary about our quarterly performance and importantly, our outlook for the remainder of 2023. As you know, our strategy includes 3 main pillars: reinvesting in our business, growing and paying dividends and repurchasing our shares. In the first 3 months of 2023, we have invested $2.5 billion in internal R&D and returned $2.3 billion to shareholders via our quarterly dividend. And importantly, allocated approximately $43 billion for the proposed Seagen acquisition. Over the last few years, we have reinvested heavily into our business to drive long-term growth and enhance long-term shareholder value. We have invested in Pfizer's own science while acquiring the best external science to supplement our pipeline.

謝謝你，阿爾伯特，大家早安。我想先介紹輝瑞的資本配置策略，然後再深入討論我們的季度業績，以及我們對 2023 年剩餘時間的展望。如您所知，我們的策略包括三大支柱：再投資於我們的業務、成長和支付股息以及回購我們的股票。 2023 年前 3 個月，我們在內部研發上投資了 25 億美元，並透過季度股息向股東返還了 23 億美元。而且重要的是，為擬議的 Seagen 收購案撥款約 430 億美元。在過去幾年裡，我們對業務進行了大規模再投資，以推動長期成長並提高長期股東價值。我們投資了輝瑞自身的科學，同時獲得了最好的外部科學來補充我們的產品線。

Since 2022, we have invested approximately $70 billion, including Seagen in business development. In addition, we have continued to grow our dividend. For the past 14 years, we have raised our dividend annually. Since 2010, our quarterly cash dividend grew from $0.16 a share to $0.41 a share in 2023.

自 2022 年以來，我們已投資約 700 億美元，包括對 Seagen 的業務發展投資。此外，我們持續增加股利。過去 14 年來，我們每年都會增加股利。自 2010 年以來，我們的季度現金股利從每股 0.16 美元成長到 2023 年的每股 0.41 美元。

Looking ahead, as we exit this unprecedented period of anticipated launches, we would expect to achieve operating margin improvement over time. As we began to de-lever our capital structure after the closing of the Seagen transaction, we expect to return to a more balanced capital allocation mix between our 3 pillars. While we will continue to invest in our business, we do expect more balance between that priority and returning value to our shareholders via increased dividends and value-enhancing share repurchases. Our capital allocation strategy is squarely focused on driving shareholder value, while at the same time, remaining committed to a high investment-grade Tier 1 commercial paper rating. Now turning to the quarter.

展望未來，隨著我們走出這段前所未有的預期發布時期，我們預計隨著時間的推移，營業利潤率將會提高。在 Seagen 交易結束後，我們開始降低資本結構的槓桿率，我們預計三大支柱之間的資本配置組合將更加平衡。雖然我們將繼續對我們的業務進行投資，但我們確實期望在這一優先事項與透過增加股息和增值股票回購為股東帶來價值回報之間取得更多平衡。我們的資本配置策略完全專注於提高股東價值，同時，繼續致力於獲得高投資級一級商業票據評級。現在轉向本季。

As Albert said, our results were in line with our expectations, albeit slightly better than consensus. As expected, overall revenues declined 26% operationally, primarily driven by the anticipated decline in commodity, which was partially offset by strong Paxlovid sales. I want to point out that our COVID-19 products produced $7.1 billion in revenues in the first quarter alone. Our non-COVID operational revenue growth was solid at 5% year-over-year. Primarily driving this growth was the inclusion of Nurtec ODT and Oxbryta and an increase in Sulperazon revenues in China. Revenues for Eliquis in the U.S. and the Vyndaqel family globally also contributed to this growth.

正如阿爾伯特所說，我們的結果符合我們的預期，儘管略優於普遍預期。如預期，整體營運收入下降了 26%，主要原因是商品預期下降，但 Paxlovid 的強勁銷售部分抵消了下降。我想指出的是，光是第一季度，我們的 COVID-19 產品就創造了 71 億美元的收入。我們的非新冠疫情營運收入較去年同期穩定成長 5%。推動這一成長的主要因素是 Nurtec ODT 和 Oxbryta 的納入以及 Sulperazon 在中國的收入增加。 Eliquis 在美國和 Vyndaqel 家族在全球的收入也促進了這一增長。

Now I want to remind you of the seasonality of some of our products. In the first quarter, Nurtec ODT and Oxbryta typically have lower sales quarter-on-quarter due to annual copay reset dynamics with higher sales anticipated in the latter quarters. Most importantly, both products continue to experience strong growth in demand. Sulperazon revenues increased more than $100 million year-over-year due to higher demand in China during the quarter, which we do not expect to be sustained going forward. The demand was due to increased bacterial infection from patients being hospitalized for COVID. To help ensure the success of the expected launches of a large number of new and acquired products and indications, we've increased our investments in SI&A. These investments are squarely focused on Pfizer's 2025 to 2030 growth aspirations.

現在我想提醒您注意我們某些產品的季節性。在第一季度，由於年度共付額重置動態，Nurtec ODT 和 Oxbryta 的銷售額通常比上一季下降，預計後幾季的銷售額會更高。最重要的是，這兩種產品的需求持續強勁成長。由於本季中國需求增加，Sulperazon 的營收年增了 1 億多美元，但我們預計這種成長態勢未來不會持續。這項需求是由於因 COVID 住院的患者細菌感染增加所致。為了確保大量新產品和收購產品及適應症的預期上市成功，我們增加了對 SI&A 的投資。這些投資完全集中在輝瑞 2025 年至 2030 年的成長目標。

Now moving to the bottom line. Reported diluted earnings per share this quarter declined by 29% to $0.97 a share, while Adjusted diluted earnings per share of $1.23 declined 20% on an operational basis during the quarter. Once again, this quarter, foreign exchange movements significantly impacted our results, reducing first quarter revenues by $730 million or 3% and Adjusted diluted earnings per share by $0.07 or 4% compared to LY.

現在轉到底線。本季報告的每股攤薄收益下降 29% 至每股 0.97 美元，而本季調整後的每股攤薄收益為 1.23 美元，按營運基礎計算下降 20%。本季度，外匯變動再次對我們的業績產生了重大影響，與去年同期相比，第一季營收減少了 7.3 億美元，即 3%，調整後每股攤薄收益減少了 0.07 美元，即 4%。

Now turning to the full year financial outlook for the company. Our full year 2023 guidance remains unchanged. On a total company basis, we continue to expect revenues of $67 billion to $71 billion, reflecting an operational decline of 31% at the midpoint, with 5% operational growth in our non-COVID revenues this quarter, we are on track to achieve our non-COVID revenue guidance of 7% to 9% operational growth for the full year. Given that a large number of launches are expected to incur in the third and fourth quarter of '23, we anticipate our quarterly revenues will not be linear this year and that our non-COVID revenues will grow more quickly in the back half of this year versus the first half of '23.

現在來談談該公司的全年財務前景。我們對 2023 年全年的預期保持不變。從整個公司的角度來看，我們繼續預計收入為 670 億美元至 710 億美元，中間值反映出 31% 的營運下降，本季非 COVID 收入的營運成長了 5%，我們預計將實現全年非 COVID 收入 7% 至 9% 的營運成長預期。鑑於預計 23 年第三季和第四季將有大量產品上市，我們預計今年季度營收將不會呈線性增長，並且今年下半年的非 COVID 收入將比 23 年上半年增長更快。

In terms of our COVID products, Comirnaty and Paxlovid, we expect sales to trend more seasonally this year. Given these dynamics, we expect significantly lower sales contributions from our COVID products in the second quarter versus the first quarter. In fact, given the anticipated timing of approvals for a fall vaccine with strain change, we would expect more substantial vaccine deliveries to start in September, which is late in the U.S. third quarter and the beginning of our international fourth quarter. With respect to Paxlovid, we continue to expect '23 to be a transitional year as we anticipate shifting to a commercial market in the second half of this year. We are reaffirming our Adjusted diluted earnings per share guidance range of $3.25 to $3.45 per share. On a full year basis, we expect that foreign exchange will have an unfavorable impact compared with full year 2022 of approximately $0.13 on Adjusted diluted earnings per share. We are also reaffirming the remaining components of our full year 2023 guidance which you can find in the appendix of the Q1 '23 earnings presentation.

就我們的 COVID 產品 Comirnaty 和 Paxlovid 而言，我們預計今年的銷售趨勢將更具季節性。鑑於這些動態，我們預計第二季我們的 COVID 產品的銷售貢獻將較第一季大幅下降。事實上，考慮到預計秋季批准帶有毒株變化的疫苗的時間，我們預計更大量的疫苗交付將在 9 月開始，也就是美國第三季末和我們國際第四季初。對於 Paxlovid 而言，我們繼續預計 23 年將是一個過渡年，因為我們預計今年下半年將轉向商業市場。我們重申調整後每股攤薄收益預期範圍為 3.25 美元至 3.45 美元。從全年來看，我們預計與 2022 年全年相比，外匯將對調整後每股稀釋收益產生約 0.13 美元的不利影響。我們也重申了 2023 年全年指引的其餘部分，您可以在 2023 年第一季財報的附錄中找到。

So in closing, this is an exciting period for Pfizer as we continue to invest to drive long-term growth and, importantly, enhance long-term shareholder value.

總而言之，對於輝瑞來說，這是一個令人興奮的時期，因為我們將繼續投資以推動長期成長，更重要的是，提高長期股東價值。

With that, now let me turn it over to Mikael.

現在，讓我把話題交給米凱爾 (Mikael)。

Thank you, Dave. Today I would like to start off with one of the four pillars of our oncology portfolio, which are breast, urogenital, blood cancers and precision medicine.

謝謝你，戴夫。今天，我想先介紹我們的腫瘤學四大支柱之一，即乳癌、泌尿生殖系統癌症、血癌和精準醫療。

Within urogenital, prostate cancer is an area in which we have strong momentum. Recent positive study results further strengthen our franchise, building upon the global standard of care set by XTANDI, and underscoring our long-standing commitment to the pursuit of breakthroughs that define new standards of care in prostate cancer.

在泌尿生殖系統領域，攝護腺癌是我們發展勢頭強勁的一個領域。最近的積極研究結果進一步加強了我們的特許經營權，建立在XTANDI 制定的全球治療標準之上，並強調了我們長期致力於追求突破的承諾，以定義前列腺癌治療的新標準。

I will highlight data from two Phase 3 studies, EMBARK and TALAPRO-2, as well as early, but promising signals from our EZH2 inhibitor, each of which has the potential to reach broader patient populations across the treatment continuum in prostate cancer. Final analysis from TALAPRO-2, evaluating our potential blockbuster PARP inhibitor TALZENNA, in combination with XTANDI were presented at ASCO GU. Results showed significant and clinically meaningful improvement across the all-comers population in radiographic progression-free survival or rPFS, in men with metastatic castration-resistant prostate cancer with or without homologous recombination repair or HRR gene mutation. There was a 37% reduction in risk of disease progression.

我將重點介紹兩項 3 期研究 EMBARK 和 TALAPRO-2 的數據，以及我們的 EZH2 抑制劑的早期但有希望的信號，每一項都有可能在前列腺癌的整個治療過程中惠及更廣泛的患者群體。 TALAPRO-2 的最終分析評估了我們的潛在重磅炸彈級 PARP 抑制劑 TALZENNA 與 XTANDI 的聯合作用，並在 ASCO GU 上進行了展示。結果顯示，在所有患有轉移性去勢抵抗性前列腺癌（無論是否伴有同源重組修復或 HRR 基因突變）的男性中，放射學無進展生存期或 rPFS 在所有人群中均有顯著且具有臨床意義的改善。疾病進展風險降低了37％。

Median rPFS in patients treated with TALZENNA and XTANDI was not reached at the time of analysis versus 21.9 months for placebo plus XTANDI. A trend in overall survival favoring TALZENNA plus XTANDI was also observed, though these data are immature. The final OS data will be reported once the predefined number of survival events has been reached. Treatment with TALZENNA and XTANDI resulted in statistically significant improvement in overall response rates, which suggests a potential cooperative effect between the two treatments.

分析時，接受 TALZENNA 和 XTANDI 治療的患者的中位 rPFS 未達到，而接受安慰劑加 XTANDI 治療的患者的中位 rPFS 為 21.9 個月。儘管這些數據尚不成熟，但我們也觀察到 TALZENNA 加 XTANDI 的整體存活率趨勢更佳。一旦達到預定義的生存事件數量，就會報告最終的 OS 數據。 TALZENNA 和 XTANDI 治療使整體反應率在統計上顯著提高，這表明兩種治療之間存在潛在的協同作用。

The U.S. FDA has granted Priority Review for our sNDA for TALZENNA in combo with XTANDI for metastatic castration-resistant prostate cancer with a decision expected in '23. The ongoing TALAPRO-3 study, if successful, may further expand the reach of this potential blockbuster into the HRR-deficient metastatic castration sensitive population. We recently presented data from our Phase 3 EMBARK study, evaluating XTANDI plus leuprolide in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence at the American Urological Association's '23 Annual Meeting. The study met its primary endpoint with statistically significant and clinically meaningful improvement in metastasis-free survival with a 58% reduction in risk for radiographic progression or death. Key secondary endpoints were met, including time to PSA progression. These results suggest XTANDI, the only novel hormone therapy approved for 3 disease states of prostate cancer in the U.S., has the potential if approved to expand to patients in the hormone-sensitive or castration-sensitive setting for the first time.

美國 FDA 已對我們 TALZENNA 與 XTANDI 聯合用於治療轉移性去勢抵抗性前列腺癌的 sNDA 進行優先審查，預計將於 23 年做出決定。正在進行的 TALAPRO-3 研究如果成功，可能會進一步擴大此潛在重磅藥物在 HRR 缺陷的轉移性去勢敏感族群中的覆蓋範圍。我們最近在美國泌尿協會第 23 屆年會上展示了我們的 3 期 EMBARK 研究的數據，該研究評估了 XTANDI 聯合亮丙瑞林對具有高生化復發風險的非轉移性激素敏感性前列腺癌男性的療效。該研究達到了其主要終點，無轉移存活率有統計學和臨床意義的顯著改善，放射學進展或死亡風險降低了 58%。達到了關鍵次要終點，包括 PSA 進展時間。這些結果表明，XTANDI 是美國唯一獲準用於治療三種前列腺癌疾病狀態的新型荷爾蒙療法，若獲批，有可能首次擴大至荷爾蒙敏感型或去勢敏感型患者。

Next, I'd like to share early data from one of our next wave candidate, a potential first-in-class and best-in-class EZH2 inhibitor, which we shorthand as 1497. EZH2 is an epigenetic transcriptional repressor that frequently over-expressed in prostate cancer. We believe that inhibition of EZH2 may provide synergistic effects in combination with XTANDI with a potential to address unmet needs of patients with androgen-sensitive and resistant disease. Here, our data from our ongoing Phase 1/2 study evaluating 1497 in second-line mCRPC patients with prior abiraterone and/or XTANDI and up to one line of chemo.

接下來，我想分享我們下一波候選藥物之一的早期數據，它是一種潛在的同類首創和最佳 EZH2 抑制劑，我們將其簡稱為 1497。 EZH2 是一種表觀遺傳轉錄抑制因子，在前列腺癌中經常過度表現。我們相信，抑制 EZH2 可能與 XTANDI 聯合產生協同效應，有可能滿足雄性激素敏感和抵抗性疾病患者的未滿足需求。這裡是我們正在進行的 1/2 期研究的數據，該研究評估了 1497 對既往接受過阿比特龍和/或 XTANDI 治療且接受過一線化療的二線 mCRPC 患者的作用。

On the left are updated data from a Phase 1 dose escalation study shared at ESMO last year. These encouraging results show durable antitumor activity in both XTANDI-naive and experienced patients, with all XTANDI-naive patients having received prior abiraterone. Importantly, this suggests that the addition of our EZH2 inhibitor has the potential to sensitize XTANDI-resistant tumors, which is an increasing clinical unmet need. The early rPFS data also highly encouraging, reaching 8.7 months in XTANDI-experienced and 17.1 months in XTANDI-naive, both of which are notably longer than historical controls. For example, in the control arm of the CARD study, rPFS for XTANDI alone was only 4.8 months in XTANDI-naive patients.

左側是去年在 ESMO 上分享的第 1 期劑量遞增研究的最新數據。這些令人鼓舞的結果顯示，XTANDI 初治患者和已接受過該治療的患者均具有持久的抗腫瘤活性，且所有未接受 XTANDI 治療的患者均曾接受過阿比特龍治療。重要的是，這表明添加我們的 EZH2 抑制劑有可能使 XTANDI 抗藥性腫瘤變得敏感，而這是一種日益增長的臨床未滿足的需求。早期 rPFS 數據也令人十分鼓舞，接受 XTANDI 治療的患者達到 8.7 個月，未接受 XTANDI 治療的患者達到 17.1 個月，這兩個數據都明顯長於歷史對照。例如，在 CARD 研究的對照組中，未接受 XTANDI 治療的患者單獨使用 XTANDI 的 rPFS 僅為 4.8 個月。

And although cross-trial comparison cannot be made these results in combination with emerging objective response rate and PSA50 response are supportive of the contribution of our EZH2 inhibitor candidate in driving these responses. From a safety perspective, the combination was generally well tolerated with mostly Grade 1 and 2 events. The randomized Phase 2 study in second-line mCRPC is ongoing with data expected early '24.

儘管無法進行交叉試驗比較，但這些結果與新出現的客觀反應率和 PSA50 反應相結合，支持了我們的 EZH2 抑制劑候選藥物在推動這些反應方面的貢獻。從安全角度來看，該組合通常耐受性良好，主要發生 1 級和 2 級事件。二線 mCRPC 的隨機 2 期研究正在進行中，預計 24 年初將獲得數據。

Now we turn to the potential for near-term growth across our respiratory vaccine franchise. Prevnar 20 or our 20-valent pneumococcal conjugate vaccine is now approved for children aged 6 weeks through 17 years. We are confident in our ability to maintain leadership in the pneumococcal vaccine space with Prevnar 20, which offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine helping to protect against the 20 serotypes in the vaccine. We have strong momentum with our RSV vaccine candidate, having received a positive VRBPAC committee vote, supporting potential approval to help combat RSV in older adults and PDUFA dates for our older adults and maternal indications in quick succession in the coming months. And just last month, New England Journal of Medicine published results from the 2 positive Phase 3 studies.

現在我們來談談呼吸道疫苗系列的近期成長潛力。 Prevnar 20 或我們的 20 價肺炎鏈球菌結合疫苗現在已獲準用於 6 週至 17 歲的兒童。我們相信，憑藉 Prevnar 20，我們能夠保持在肺炎球菌疫苗領域的領先地位，該疫苗提供所有兒童肺炎球菌結合疫苗中最廣泛的血清型覆蓋範圍，有助於預防疫苗中的 20 种血清型。我們的 RSV 候選疫苗發展勢頭強勁，已獲得 VRBPAC 委員會的積極投票，支持該疫苗可能獲得批准，用於幫助老年人對抗 RSV，並將在未來幾個月內迅速確定老年人和產婦適應症的 PDUFA 日期。就在上個月，《新英格蘭醫學雜誌》發表了兩項積極的第三階段研究的結果。

Emerging data from the middle of the second RSV season in the Northern Hemisphere in the Phase 3 older adult study support meaningful durable vaccine efficacy. We will share the data once completed. In the coming months, we plan to start the Phase 3 study of the RSV vaccine candidate in 18- to 60-year-olds at high-risk for RSV and in immunocompromised adults 18 and over and a Phase 1 study in 2 to 18 year old at high risk.

在第 3 階段老年人研究中，北半球第二個 RSV 季節中期出現的數據支持疫苗具有有意義的持久效力。一旦完成，我們就會分享數據。在接下來的幾個月裡，我們計劃針對 18 至 60 歲的呼吸道合胞病毒感染高風險族群和 18 歲以上免疫功能低下的成年人啟動呼吸道合胞病毒候選疫苗的 3 期研究，並針對 2 至 18 歲的高風險族群啟動 1 期研究。

With the potential to expand broadly the reach of our vaccine candidate, both to those age 18 to 60 with high-risk condition as well as to pediatrics and adolescents.

我們候選疫苗的覆蓋範圍有可能大大擴大，既可涵蓋 18 至 60 歲的高風險族群，也可覆蓋兒科和青少年。

Our RSV-flu coadministration study met its primary endpoint, demonstrating non-inferiority for all four flu strains and the RSV A and B strains. This suggest the RSV vaccine candidate, if approved, could be co-administered with flu vaccination and add an important component of seasonal protection against respiratory pathogens.

我們的 RSV-flu 共同給藥研究達到了其主要終點，證明了所有四種流感病毒株以及 RSV A 和 B 病毒株的非劣效性。這表明，如果獲得批准，RSV 候選疫苗可以與流感疫苗同時使用，並增加對呼吸道病原體的季節性保護的重要組成部分。

Finally, the FDA recently updated the EUA for our Omicron BA.4/5 bivalent COVID-19 vaccine to enable those at high risk of severe COVID-19 illness, including the elderly and immunocompromised to partner with the health care providers to be proactive in helping them to protect themselves against COVID-19. We anticipate another update from FDA in June that will provide guidance on COVID-19 vaccine strains and vaccination timing for the 2023 fall and winter season. Beyond vaccines, antivirals are an important component of our strategy in respiratory viruses. Here, we share data for the first time from our second gen oral COVID-19 antiviral candidate, a potent and selective SARS-CoV-2 Mpro inhibitor that is currently in Phase 1. We designed this candidate to achieve clinical exposure that would have similar antiviral activity to PAXLOVID, but without the need for ritonavir boosting and with the potential for reduced drug interactions.

最後，FDA 最近更新了我們的 Omicron BA.4/5 雙價 COVID-19 疫苗的 EUA，以使那些患有嚴重 COVID-19 疾病風險較高的人（包括老年人和免疫功能低下者）能夠與醫療保健提供者合作，積極主動地幫助他們保護自己免受 COVID-19 的侵害。我們預計 FDA 將在 6 月發布另一份更新，為 2023 年秋冬季的 COVID-19 疫苗株和接種時間提供指導。除了疫苗之外，抗病毒藥物也是我們對抗呼吸道病毒策略的重要組成部分。在這裡，我們首次分享了第二代口服 COVID-19 抗病毒候選藥物的數據，該藥物是一種強效且選擇性的 SARS-CoV-2 Mpro 抑制劑，目前處於第 1 階段。我們設計此候選藥物以實現與 PAXLOVID 具有相似抗病毒活性的臨床暴露，但不需要利托那韋增強，並有可能減少藥物交互作用。

Early results from Phase 1 dose escalation are encouraging with no dose-limiting safety tolerability findings. Dosing achieve concentration manyfold over in vitro EC90 and is, therefore, expected to have similar antiviral activity to PAXLOVID. On the right of preliminary results from our Phase 1 pharmacokinetic study of midazolam drug interaction, which is a well-known standard for indicating CYP3A4-mediated drug-drug interaction.

階段 1 劑量遞增的早期結果令人鼓舞，沒有發現劑量限制性安全耐受性發現。劑量達到體外 EC90 濃度的許多倍，因此預計具有與 PAXLOVID 相似的抗病毒活性。右側是我們對咪達唑侖藥物交互作用的第 1 階段藥物動力學研究的初步結果，這是指示 CYP3A4 介導的藥物 - 藥物交互作用的著名標準。

These data show there is a lack of such drug-drug interactions, suggesting there may be no related restrictions of co-dosing with drugs metabolized by CYP enzymes.

這些數據表明缺乏此類藥物間相互作用，表明與 CYP 酶代謝的藥物共同給藥可能沒有相關的限制。

Based on these encouraging data, we are planning to advance to Phase 2 dose-ranging study in the first half of this year.

基於這些令人鼓舞的數據，我們計劃在今年上半年推進到第二階段劑量範圍研究。

In addition to the assets I spoke about today, we continue to make progress on the pipeline with more than 25 milestones recently achieved or anticipated through the first half of '24. As examples, in inflammation and immunology, the FDA has approved our sNDA for CIBINQO, enabling a label expansion for adolescents with moderate-to-severe dermatitis. In internal medicine, ZAVZPRET, the migraine nasal spray has received FDA approval expanding our migraine portfolio. Recently, the FDA Advisory Committee voted in support of PAXLOVID's favorable benefit-risk profile with a soon PDUFA date in May.

除了我今天談到的資產之外，我們還繼續在管道方面取得進展，最近已實現或預計在 24 年上半年將實現超過 25 個里程碑。例如，在發炎和免疫學方面，FDA 已批准我們針對 CIBINQO 的 sNDA，因此可以將標籤擴展到患有中度至重度皮膚炎的青少年。在內科領域，偏頭痛鼻噴劑 ZAVZPRET 已獲得 FDA 批准，擴大了我們的偏頭痛產品組合。最近，FDA 諮詢委員會投票支持 PAXLOVID 良好的效益風險狀況，並將於 5 月確定 PDUFA 日期。

In closing, we are very excited about the potentially transformative catalyst expressed across the entire pipeline as we work with continued urgency to bring breakthroughs to patients. Thank you.

最後，我們對整個管道所表現出的潛在變革催化劑感到非常興奮，我們將繼續迫切地努力為患者帶來突破。謝謝。

Let me turn it over to Chris to start Q&A.

讓我把話題交給克里斯開始問答。

Thank you, Mikael. All right. Chelsea, please queue up us for Q&A. We have at least 30 minutes for Q&A.

謝謝你，米凱爾。好的。切爾西，請為我們安排問答時間。我們至少有 30 分鐘的時間進行問答。

(Operator Instructions) And our first question will come from Umer Raffat with Evercore ISI.

(操作員指示)我們的第一個問題來自 Evercore ISI 的 Umer Raffat。

I have 2 here, if I may. First, your expectations on the cisplatin eligibles in the EV-302 trial especially because it's so significant to the acquisition you're going down the track on? And then secondly, based on my...

如果可以的話，我這裡有 2 個。首先，您對 EV-302 試驗中順鉑的合格藥物有何期望，尤其是因為它對於您正在進行的收購至關重要？其次，基於我的…

Umer, can you repeat the question, I'm not sure, we understood it.

烏梅爾，你能重複這個問題嗎？我不確定，我們明白了。

Sure. On the Seagen trial on PADCEV, EV-302, I know there's been a huge emphasis on cohort K, which is a cisplatin ineligible. My question is, this ongoing trial also has cisplatin-eligibles, which is 2/3 of the target population. What's your expectation there? Because it was -- I felt like it was not a coincidence, Seagen never showed any data disclosure from the eligibles Part A. And secondly, for the guidance for the full year, I noticed there's perhaps $1 billion-or-so worth of contribution from new launches. And I'm just trying to make sense of that in light of the fact that these are going to be launches sort of in the fall of this year? I realize it's important like RSV, elranatamab, but is it reasonable to expect $1 billion-or-so, so early into the launch from those?

當然。在 PADCEV 的 Seagen 試驗（EV-302）中，我知道重點關注的是 K 組，該組不適合使用順鉑。我的問題是，這項正在進行的試驗也有適合使用順鉑的患者，佔目標族群的 2/3。您對此有何期望？因為它是——我覺得這不是巧合，Seagen 從未顯示任何來自合格 A 部分的數據披露。其次，對於全年指導，我注意到新推出的股票貢獻可能有價值 10 億美元左右。我只是想弄清楚，鑑於這些產品將在今年秋季推出，對嗎？我知道它和 RSV、elranatamab 一樣重要，但是期待這些藥物在推出初期就能獲得 10 億美元左右的銷售額合理嗎？

Yes. Thank you very much. Angela, why don't you take the second question about the guidance, about $1 billion estimated sales in the last quarter.

是的。非常感謝。安琪拉，您好！第二個問題是關於預期，上個季度的預期銷售額約為 10 億美元。

Sure. So from a launch perspective, I think the 2 big ones to look out for this year are Prevnar 20 peds and RSV adult. And as you know, it goes through the typical ACIP process for recommendation and then launches can really only happen or commercialization after the publication of MMWR. So if you consider all of that, that puts us into fourth quarter, which is when Prevnar 20 peds as well as when RSV older adult will actually be commercialized and revenue being generated. And so yes, we are anticipating that there's going to be a big bolus of revenue because, first of all, if you think about Prevnar 20 peds, that is going to be a conversion from Prevnar 13 peds and Prevnar 13 today has a significant market share, right, in pediatric pneumococcal is 80% market share.

當然。因此從發布的角度來看，我認為今年最值得關注的兩個重大問題是 Prevnar 20 兒童疫苗和 RSV 成人疫苗。如您所知，它要經過典型的 ACIP 流程進行推薦，然後只有在 MMWR 發布後才能真正啟動或商業化。因此，如果將所有這些考慮在內，我們將進入第四季度，屆時 Prevnar 20 兒童版以及 RSV 老年人版將真正商業化並產生收入。因此是的，我們預計收入將會大幅增加，因為首先，如果您考慮兒科 Prevnar 20，那將是兒科 Prevnar 13 的轉化，而 Prevnar 13 目前佔有相當大的市場份額，在兒科肺炎球菌領域佔有 80% 的市場份額。

So we're going to be converting those accounts, the physicians, the inventory, all of that from 13 over to 20. And so if you look at, I guess, a good analogue for that would be our Prevnar 20 adult launch, which was the conversion of the Prevnar 13 adult launch. And there, it went really well. Today, we have, what, over 95% market share. And then, of course, the second one is the RSV adult. And there, it plugs into an already established commercial infrastructure that we've built around COVID, around the Prevnar franchise, the adult franchise. It comes at a great time during the fall and the winter when vaccinations for respiratory vaccines actually increases. So there's a lot of reasons to believe why that fourth quarter is going to be a really big quarter for both Prevnar peds as well as RSV adult.

因此，我們將把這些帳戶、醫生、庫存等從 13 轉換為 20。所以，如果你看一下，我想，一個很好的類比就是我們的 Prevnar 20 成人版，它是 Prevnar 13 成人版的轉換。一切進展順利。今天，我們的市佔率超過 95%。當然，第二個是RSV成蟲。而且，它融入了我們圍繞 COVID、Prevnar 特許經營權和成人特許經營權構建的已建立的商業基礎設施。現在正值秋冬季節，呼吸道疫苗接種數量實際增加，這是一個好時機。因此，有很多理由相信，第四季度對於 Prevnar 兒童患者和 RSV 成人患者來說都將是一個真正重要的季度。

Thank you, Angela. On the question about the Seagen asset, although we should be very careful because we can't comment on that. But maybe you can make William quick comments, generally speaking.

謝謝你，安吉拉。關於 Seagen 資產的問題，我們應該非常小心，因為我們無法對此發表評論。但也許你可以對威廉做出簡短的評論，一般來說。

Yes, sure. I would say we're just very excited about the recent approval in the first-line cisplatin ineligible population, which Seagen just got, which is about 8,000 to 9,000 patients in the U.S. And we're excited to see additional data coming in the first-line cisplatin eligible EV-302 study, which, as you know, is Padcev plus pembro versus platinum gemcitabine. We can't comment any further at that Seagen study. And if that is positive that would increase the eligible population by another 10,000 to 12,000.

是的，當然。我想說的是，我們對 Seagen 剛剛獲得的針對一線順鉑不合格人群的批准感到非常興奮，該人群約有 8,000 至 9,000 名美國患者。我們很高興看到一線順鉑合格 EV-302 研究中獲得更多數據，如您所知，該研究是 Padcev 加 pembro 與鉑類吉西他濱的比較。我們無法對 Seagen 的研究發表進一步評論。如果結果為正，那麼符合條件的人口將再增加 10,000 至 12,000 人。

Doubling the population that excites us. But of course, we can't comment on Seagen's progress.

人口增加一倍讓我們興奮不已。但當然，我們無法評論 Seagen 的進展。

Our next question will come from Evan Seigerman with BMO Capital Markets.

我們的下一個問題來自 BMO 資本市場的 Evan Seigerman。

This is Keith on for Evan. Maybe just shifting to M&A execution. Thinking about your recent acquisitions with Nurtec and Oxbryta. You've done a great job describing the plans to add value, drive commercial and clinical synergies. We're seeing the outcomes on our end. Could you comment on how this is going from year-end? And then could you talk about specifics for operationalizing the same for Seagen integration, and how this would differ from recent examples, that would be great.

這是 Keith 代替 Evan 發言。也許只是轉向併購執行。考慮您最近與 Nurtec 和 Oxbryta 的收購。您在描述增加價值、推動商業和臨床協同效應的計劃方面做得非常出色。我們正在看到結果。您能評論一下年底的進展嗎？然後，您能否談談 Seagen 整合的具體操作細節，以及這與最近的例子有何不同，那就太好了。

Again, Angela, back to you.

安琪拉，再次回到你身邊。

Sure. So we are incredibly proud of the work that we've done with -- on Nurtec since the acquisition. As you know, in July of 2022, we had already begun a co-promote with Biohaven to ensure that we were co-promoting the product early. And I think that has really paid off. If you really look at what has happened from a just leading indicators as well as actuals. Today, Nurtec is the leading product in the oral CGRP class with over 47.5% market share. It is also the leading product when it comes to new-to-brand prescription share at a high of 46%. It also has the highest number of prescribers at over 110,000 prescribers and 80% of new CGRP prescribers choose Nurtec.

當然。因此，我們對自收購 Nurtec 以來所做的工作感到無比自豪。如您所知，2022 年 7 月，我們已經開始與 Biohaven 共同推廣，以確保我們儘早共同推廣此產品。我認為這確實取得了回報。如果您認真從領先指標和實際情況來觀察發生了什麼。如今，Nurtec 是口服 CGRP 類產品的領先產品，市佔率超過 47.5%。它也是新品牌處方份額最高的產品，高達 46%。其處方人員數量也最多，超過 110,000 名，並且 80%​​ 的新 CGRP 處方人員選擇了 Nurtec。

So I think we've demonstrated in the time that we've had it, that we are able to drive performance and drive excellent education and awareness of the product. And we're seeing consistent great metrics as it pertains to Nurtec. And of course, the opportunity is huge, right? Because we have zavegepant launching later this year. We also know that as a whole, there are over 1 billion migraine sufferers and only 18% of them are using CGRPs today. So we have a great opportunity to expand the class of CGRPs, but specifically Nurtec.

所以我認為，我們已經證明，我們能夠提高性能，並推動對產品的卓越教育和認知。就 Nurtec 而言，我們看到了一致的出色指標。當然，機會是巨大的，對吧？因為我們今年稍後會推出 zavegepant。我們也知道，全球偏頭痛患者總數超過 10 億，其中只有 18% 目前正在使用 CGRP。因此，我們有很好的機會擴大 CGRP 類別，特別是 Nurtec。

Thank you, Angela. Next question, please.

謝謝你，安吉拉。請回答下一個問題。

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

我們的下一個問題來自富國銀行的 Mohit Bansal。

If I may ask 2 questions here. So on European negotiation, just because there was some news this week. Just how much can you comment on that? And the real question there is that, I know you when you provided guidance in the beginning of the year, you anticipated some of that. But so far as the negotiation see any risk to the guidance as the negotiations get finalized in that? And the other question I have is more about the -- your demand chart for PAXLOVID in vaccinations board. It seems like you are assuming both PAXLOVID and vaccination utilization going up into 2024 plus timeframe. Would it be both demand -- demands going up, or do you think it will be either or as vaccinations come down, probably the demand for PAXLOVID would go up. How should we think about that?

我可以在這裡問兩個問題。關於歐洲談判，只是因為本周有一些消息。您對此能發表多少評論呢？真正的問題是，我知道當您在年初提供指導時，您已經預料到了其中的一些情況。但就談判而言，隨著談判的完成，您認為該指導方針是否有風險？我的另一個問題是關於——疫苗接種委員會對 PAXLOVID 的需求圖表。看起來您假設 PAXLOVID 和疫苗接種的使用率都會上升到 2024 年以後的時間範圍。是兩種需求都會上升，還是您認為會是其中一種，或者隨著疫苗接種的減少，對 PAXLOVID 的需求可能會上升。我們該如何思考這個問題？

Maybe I can answer those questions. So on the Seagen negotiations, they are still ongoing. So we can't comment on that. Yes, we have included part of -- included our estimation of how these negotiations will end up in our guidance. And still, we are not closing. So I can't make any comments on that. It wouldn't be appropriate as the discussions are still ongoing. As regards to the demand for PAXLOVID or for vaccines. As we had said, we expect that the demand for vaccines will go down. We gave estimations that will go down to approximately 24% of people in the U.S. and relevant numbers, different country by country as underlying demand for boosters. And things -- I think our progress towards that goal, we will have to see as most of this will happen in the last after summer when it is the traditional period that flu vaccinations are also happening. Demand for PAXLOVID right now is following very, very accurately the infection rates. So when we monitor it on a weekly basis. And really, it is going when we have almost equal percentage of infections is equal percentage of the case for PAXLOVID. And so we expect that will continue going like that. Because we have less compliance with the vaccination recommendations across the world as people are tired with COVID, and we expect that fewer people, as I said, this year will get a vaccine compared to last year. And so this means that the immune protection of the operation will go down. As a result, we expect that we have more infections and that will drive more use of PAXLOVID. But of course, that's what our epidemiological models are telling us, we'll have to see what eventually will happen in real life.

也許我可以回答這些問題。關於 Seagen 的談判仍在進行中。所以我們無法對此發表評論。是的，我們已經將部分內容——包括了我們對這些談判最終結果的估計——納入了我們的指導中。但我們仍然沒有關閉。所以我對此無法發表任何評論。由於討論仍在進行中，因此這並不合適。關於對PAXLOVID或疫苗的需求。正如我們所說，我們預計疫苗需求將會下降。我們估計，美國這一比例將下降到大約 24%，並且各國對加強劑的潛在需求存在差異。我認為，我們必須看到，我們朝著這個目標取得了進展，因為大部分進展將發生在夏季之後，因為夏季是傳統的流感疫苗接種時期。目前對 PAXLOVID 的需求與感染率非常精確地一致。因此我們每週都會對其進行監控。事實上，當我們的感染百分比幾乎與 PAXLOVID 病例百分比相等時，情況就會改變。我們預計這種情況將會持續下去。由於人們對新冠肺炎感到厭倦，世界各地對疫苗接種建議的遵守程度降低，正如我所說，我們預計今年接種疫苗的人數將比去年減少。這意味著手術的免疫保護作用將會下降。因此，我們預期感染病例會增多，這將推動 PAXLOVID 的使用。但當然，這就是我們的流行病學模型告訴我們的，我們必須看看現實生活中最終會發生什麼。

Next, we have Robyn Karnauskas with Truist Securities.

接下來是 Truist Securities 的 Robyn Karnauskas。

Just 2 big picture ones. Just first on for your vaccine franchise, we think about the competitive landscape, a couple of things. What do you think is going to be the most important differentiation for you versus the competition that will drive the most uptake as people have different options. And have you developed any new LNP technology that might reduce the biggest pushback with the vaccines as people feel sick still when they get them for some of your products. And then lastly...

只有 2 張大圖。首先，對於您的疫苗特許經營，我們考慮競爭格局和一些事情。由於人們擁有不同的選擇，您認為與競爭對手相比，您最重要的差異化是什麼？什麼將推動您獲得最大的青睞？您是否開發了任何新的 LNP 技術，可以減少人們對疫苗的最大抵制，因為人們在接種某些疫苗後仍會感到不適。最後...

We couldn't hear, which product you spoke about?

我們聽不清楚您說的是哪一種產品？

Oh, I was just talking about the (inaudible) vaccine franchise for RSV and flu and COVID, thinking big picture, how you are differentiated? And what do you think is going to be key because you're all competing to make -- to determine who's going to be the winner. And the second question is, there's big proposal out of Europe for new legislation for drugs. And since you're launching all the new products in Europe. I just want to get your thoughts on whether or not you think that legislation may hold? Or what kind of impact that might have?

哦，我剛才在談論（聽不清楚）呼吸道合胞病毒、流感和新冠肺炎疫苗的特許經營權，從大局來看，你們是如何區分的？您認為什麼是關鍵，因為大家都在競爭——決定誰是贏家。第二個問題是，歐洲提出了一項關於新藥品立法的重大提案。由於你們將在歐洲推出所有新產品。我只是想知道您認為這項立法是否可行？或者說會產生什麼樣的影響？

And maybe I can give you a very general answer, and then if Angela wants to chime in, please. On the COVID, we are the winners right now, all right? We have the big markets there. And we plan to maintain that. So I think we are there. When it comes to RSV, we are the only ones that we have both or we have positive data on both on adults and on maternal, and we have already approval for the adults and then we are expecting approval for the maternal so that the strength of our data with efficacy and safety profile that we think is differentiated, will provide us with what we hope also to be the winners in that one. And the flu on mRNA technology still the jury is out.

也許我可以給你一個非常籠統的答案，然後如果安琪拉想插話的話，請。就新冠肺炎疫情而言，我們現在是贏家，好嗎？我們在那裡有很大的市場。我們計劃繼續維持這一現狀。所以我認為我們已經到了那裡。就 RSV 而言，我們是唯一同時擁有針對成人和孕產婦的陽性數據的公司，而且我們已經獲得了針對成人的批准，然後我們期待針對孕產婦的批准，因此，我們認為具有差異化的功效和安全性數據的優勢將為我們提供我們希望成為贏家的東西。而關於 mRNA 技術的爭議還未有定論。

[In response to a question, the Pfizer spokesperson was referencing the positive vote received in February 2023 from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the RSV bivalent vaccine adults 60 years of age and older, when the spokesperson indicated that Pfizer had received approval. As noted in the earnings materials as of May 2, 2023, the above mentioned vaccine has not to date received FDA approval.] (added by company after the call)

[在回答問題時，輝瑞發言人提到了 2023 年 2 月 FDA 疫苗和相關生物製品諮詢委員會（VRBPAC）對 60 歲及以上成人 RSV 雙價疫苗投的積極票，當時發言人表示輝瑞已獲得批准。正如截至 2023 年 5 月 2 日的收益資料中所述，上述疫苗迄今尚未獲得 FDA 批准。 ]（公司在電話會議後新增）

We are very optimistic with the totality of the data that we are having from our flu vaccine, and we will wait to see, of course, how that will continue. And then, of course, the winners will be also those that they will be able to build a combination from all of that. So the fact that we have all 3 of them, or we have a good chance to have all 3 of them if the studies are successful and if the products are approved, of course, also provides a good differentiation. In addition to all of that, I think the trust for the Pfizer brand name, which has been very, very strong, I think, also plays a key differentiator.

我們對流感疫苗的全部數據非常樂觀，當然，我們將拭​​目以待，看看這種情況將如何持續下去。當然，獲勝者也將是那些能夠將所有這些組合起來的人。因此，事實上，我們擁有這三種藥物，或者說，如果研究成功並且產品獲得批准，我們很有可能擁有這三種藥物，當然，這也提供了良好的差異化。除此之外，我認為對輝瑞品牌的信任度也是一個非常非常強大的因素。

Now as regards to the EU legislation that we have just seen in the recent days, we are noticing the positive things of EU trying to be more competitive in attracting reserves and creating a regulatory framework for more rapid approvals. Clearly, we are also concerned at the same time with provisions that would like to reduce exclusivity of data and other provisions. So we hope that there will be an open dialogue with the EU so that we can create a framework that really will enhance innovation. Angela, anything that you want to add to all of that?

就我們最近幾天看到的歐盟立法而言，我們注意到歐盟在試圖提高競爭力以吸引儲備和創建更快批准的監管框架方面的積極舉措。顯然，我們同時也關注那些希望降低資料排他性的規定和其他規定。因此，我們希望與歐盟進行公開對話，以便我們能夠創建一個真正能夠促進創新的框架。安琪拉，您還有什麼要補充的嗎？

Maybe just to add to your question specifically about the adult portfolio, I really do believe that this plays into our sweet spot. You know through the last several years, both from the Prevnar franchise and for vaccination, vaccinating adults through our work in COVID, we've learned that the clinical profile is one thing that you really need reliable supply, you need a commercial infrastructure. You need a great ability to educate, raise awareness and drive people to vaccination. And I think on all of those counts, Pfizer is a winner. And so we look forward to having a growing and a very robust respiratory portfolio that really leverages off of this incredible commercial machinery.

也許只是想補充你關於成人投資組合的具體問題，我確實相信這符合我們的最佳利益。您知道，在過去幾年中，無論是從 Prevnar 特許經營權還是疫苗接種，透過我們在 COVID 方面的工作為成年人接種疫苗，我們都了解到臨床特徵是真正需要可靠供應的一件事，您需要商業基礎設施。你需要有很強的教育能力、提高認識的能力並推動人們接種疫苗。我認為從所有這些方面來看，輝瑞都是贏家。因此，我們期待擁有一個不斷增長且非常強大的呼吸產品組合，真正利用這種令人難以置信的商業機器。

Next, we have Louise Chen with Cantor.

接下來我們有請 Cantor 的 Louise Chen。

So I want to ask you about margin improvement. You talked about that in your opening remarks. I'm curious when we might start to see that? And does that include the Seagen acquisition in your comments. And second question I have for you is, what are some of the key steps that you've taken already to transition Comirnaty and PAXLOVID in the commercial market? And when will you know how the Seagen will shape up?

所以我想問您關於利潤率提高的問題。您在開場白中談到了這一點。我很好奇我們什麼時候可以開始看到這一點？您的評論中是否包括對 Seagen 的收購？我要問您的第二個問題是，您已經採取了哪些關鍵步驟來將 Comirnaty 和 PAXLOVID 推向商業市場？那麼你什麼時候才能知道 Seagen 的最終形狀呢？

Thank you very much, Louise. Dave, you want to take the margin improvements and then Angela, the Comirnaty and PAXLOVID.

非常感謝，路易絲。戴夫，你想提高利潤率，然後是安吉拉、Comirnaty 和 PAXLOVID。

Yes. Thank you for your question. It is our expectation that as we integrate Seagen in either late '23 or '24. Early '24, we will begin to see margin improvement, and that will happen as we continue to improve our performance from a top line perspective. At the same time, we're going to be very efficient and really work to minimize our SI&A investments going forward. So I think you should start to see that post the integration and the closing of the Seagen transaction.

是的。感謝您的提問。我們預計將在 23 年末或 24 年整合 Seagen。 24 年初，我們將開始看到利潤率的提高，隨著我們從營收角度繼續提高業績，這種情況也會發生。同時，我們將非常高效，並真正努力減少未來的 SI&A 投資。因此我認為您應該在 Seagen 交易整合和結束後開始看到這一點。

Thank you, David. And Angela, how are we preparing to transition commercial commitment?

謝謝你，大衛。安琪拉，我們準備如何轉變商業承諾？

So Louise, as you know, both of these products, both Comirnaty and PAXLOVID are products are very familiar to us. They fit very well in the existing portfolio of products that we have. So the ability for us to move from an EUA into a full launch or into, it is business as usual for us, right? So the typical things that we would always do, which is awareness building with physicians and with patients that has begun and is well underway. The things that you would do as a regard your discussions with payers to demonstrate value and to create your value argument for reimbursement and access, that has begun.

所以 Louise，如您所知，Comirnaty 和 PAXLOVID 這兩款產品都是我們非常熟悉的產品。它們非常適合我們現有的產品組合。那麼，我們從 EUA 轉向全面發布的能力，對我們來說，這是正常的業務，對嗎？因此，我們通常會做的事情就是與醫生和患者一起提高意識，這項工作已經開始並且正在順利進行中。您要做的事情就是與付款人進行討論，以證明價值並為報銷和訪問創建價值論點，這些事情已經開始了。

We have done a tremendous amount of work as it pertains to retailers and making sure that we have our distribution and our supply chain well-oiled and the ability to be able to supply and to vaccinate to administer these products at both -- at a physical side like a retailer or even in the case of PAXLOVID getting telehealth and sort of remote health capability set up. So all of these capabilities in many of them, in fact, have been underway throughout the entire time of the pandemic. So I think we're in a very, very good position to seamlessly transition into commercialization.

在零售商方面，我們做了大量工作，確保我們的分銷和供應鏈暢通無阻，並且有能力在零售商等實體店供應和接種這些產品，甚至在 PAXLOVID 的情況下，也建立了遠距醫療和遠距醫療能力。因此，事實上，其中許多機構的所有這些能力在整個疫情期間一直在進行中。因此我認為我們處於非常有利的位置，可以無縫過渡到商業化。

Our next question will come from Akash Tewari with Jefferies.

我們的下一個問題來自 Jefferies 的 Akash Tewari。

Can you talk about your next-gen CDK4 program? You'll have first-in-human data at ASCO. Why does your team believe just hitting CDK4 allows you to improve on IBRANCE's efficacy. And are there any plans to combine that drug with the Arvinas SERD, given the DDI that's been shown up with IBRANCE. And then on your next-gen PAXLOVID program, can you confirm that it can achieve multiple fold over the EC90 when adjusted for plasma protein binding? And is that -- for time-lines on that product, is the earliest possible commercial entry 2026? Or is there a path for expedited approval?

您能談談您的下一代 CDK4 計劃嗎？您將在 ASCO 獲得首次人體試驗數據。為什麼您的團隊認為僅達到 CDK4 就可以提高 IBRANCE 的療效。鑑於 IBRANCE 已顯示出 DDI，是否有計劃將該藥物與 Arvinas SERD 結合使用。然後，在您的下一代 PAXLOVID 程序中，您能否確認在調整血漿蛋白結合時它可以達到 EC90 的數倍？就該產品的時間表而言，最早可能在 2026 年實現商業化嗎？或是有沒有加快批准的途徑？

Thank you very much. Mikael, I think both questions can go to you.

非常感謝。米凱爾，我想這兩個問題都可以問你。

Thank you. We are very excited about the next-gen CDK4 inhibitor. It's looking really good in 2 aspects. You can dose and get activity after patients paying CDK4/6 because it deals with higher inhibition of this mechanism. And you have a better tolerability with no -- with much less neutropenia, less risk for infections. We expect midyear to report out, and we have an aspirational target to start Phase 3 late this year, possibly early. At the same time, as you asked, we are now running combination studies CDK4 with KAT6. Another inhibitor that has a nice single agent activity and seem to combine well. We have a second combination with CDK2. And we think this would allow us next year to pick 1 or 2 combinations to advance up the lines with more potent treatment what's available today. Similarly, we're looking at combination with 471, as you alluded to, in order to benefit from the Arvinas collaboration. Next Gen PAXLOVID, yes, as I alluded to in my introductory remarks, we have many fold above EC90. And as you know, for PAXLOVID, what's unique with that drug that the manifold exposure above EC90 as this fall led to no detectable meaningful emergence of mutations, which is always what you fear in antiviral single-agent therapy, and this has been unique for PAXLOVID versus other agents that have been used so far, whether antibodies or antivirals, and this is exactly the profile for the next-gen, but without DDIs that allow us to improve and also to move into other supplementary segments. We're planning soon to start a Phase 2 and pending data possibly move quickly to Phase 3. And of course, we would like to see that agent introduced as soon as possible. I think we can hope to move swiftly pending event rates of COVID that will happen in the fall and further on that influence enrollment. So I think you said '26, and I would certainly hope we'll be ahead of that.

謝謝。我們對下一代 CDK4 抑制劑感到非常興奮。從兩個方面來看它都非常好。您可以在患者支付 CDK4/6 後服用藥物並獲得活性，因為它可以處理這種機制的更高抑制。而且您的耐受性更好，中性粒細胞減少症的發生率更低，感染風險也更低。我們預計年中會出報告，我們的目標是在今年年底甚至年初啟動第三階段。同時，正如您所問的，我們現在正在進行 CDK4 與 KAT6 的聯合研究。另一種具有良好單一藥劑活性且似乎結合良好的抑制劑。我們與 CDK2 有第二種組合。我們認為，這將使我們能夠在明年挑選 1 或 2 種組合，以目前更有效的治療方法來推進治療線。同樣，正如您所提到的，我們正在研究與 471 的結合，以便從 Arvinas 合作中獲益。下一代 PAXLOVID，是的，正如我在開場白中提到的，我們的 EC90 有很多倍以上。如你所知，PAXLOVID 的獨特之處在於，當暴露於 EC90 以上時，並未出現可檢測到的、有意義的突變，而這正是抗病毒單藥療法所擔心的，與迄今為止使用過的其他藥物（無論是抗體還是抗病毒藥物）相比，PAXLOVID 是獨一無二的，這正是下一代藥物的特點，但沒有 DDI，我們可以對其進行改進領域，並進入其他領域。我們計劃很快啟動第二階段，待處理資料可能會快速進入第三階段。當然，我們希望盡快推出該藥物。我認為，我們可以期望迅速採取行動，應對秋季 COVID 疫情的爆發率以及對入學率的影響。所以我認為你說的是‘26’，我當然希望我們能夠領先於這個數字。

Next, we have Terence Flynn with Morgan Stanley.

接下來是摩根士丹利的特倫斯弗林 (Terence Flynn)。

Maybe 2 for me because I'm not sure you'll be able to answer one of them. I guess any -- would love your latest thoughts on your seasonal flu mRNA vaccine just in light of some of the Moderna data on the B-antigen side. Just how should we think about your profile there? And then there's been some focus on this ADCETRIS versus OPDIVO first-line Hodgkin's lymphoma data that's going to be presented at ASCO. Just wondering if you can offer your high-level perspective on how you see that frontline landscape evolving?

對我來說也許有 2 個，因為我不確定你是否能回答其中一個。我想任何人——都想根據 Moderna 在 B 抗原方面的一些數據，了解您對季節性流感 mRNA 疫苗的最新想法。我們到底該如何看待您在那裡的個人資料？然後，人們開始關注將在 ASCO 上展示的 ADCETRIS 與 OPDIVO 一線霍奇金淋巴瘤數據。只是想知道您是否可以從高層次的角度來看待前線情勢的發展？

Mikael, why don't you take the flu question and then the oncology question will go to William.

米凱爾，為什麼不先回答流感問題，然後腫瘤學問題就交給威廉吧。

We are very pleased what we see so far, the totality date of our flu mRNA. As you know, we have reported out very high antibody type A, similar or possibly lower to the B antigen versus standard flu vaccines. But in contrast to standard flu vaccines, we have very nice T cell activity. And I think we are the only mRNA platform that has dosed CD4 and CD8 T cells of significance. We do think that could offer a unique profile for flu and the tolerability with our dose is very encouraging. So the trial is -- in the last leg for a readout. Hopefully, we'll be able later before to share an update. And we are very encouraged, and we are in parallel at risk investing in combination opportunities with recent COVID and RSV in various combination, as Albert earlier alluded to.

我們對迄今為止看到的流感 mRNA 的完整日期感到非常滿意。如您所知，我們報告的 A 型抗體水平非常高，與標準流感疫苗的 B 抗原相似或可能更低。但與標準流感疫苗相比，我們的 T 細胞活性非常好。我認為我們是唯一一個對 CD4 和 CD8 T 細胞進行有意義劑量控制的 mRNA 平台。我們確實認為這可以為流感提供獨特的治療方案，而且我們劑量的耐受性非常令人鼓舞。因此，此次審判已進入最後階段。希望我們稍後能夠分享更新內容。我們感到非常鼓舞，同時我們正在冒險投資近期與 COVID 和 RSV 以各種組合方式相結合的機會，正如 Albert 之前提到的。

Thank you, Mikael. And William, on the oncology front, how do you feel about?

謝謝你，米凱爾。威廉，關於腫瘤學方面，您有什麼感想？

Yes, sure. So again, this is a molecule for Seagen ADCETRIS, which is the CD30 ADC. It's already been approved in Hodgkin's lymphoma post-transplant and then in previously untreated Hodgkin's lymphoma now with chemotherapy, doxorubicin, vinblastine and dacarbazine. And it's already -- we anticipate actually later this year that the label will be updated for overall survival. Now the data you're talking about is from the SWOG S1826 study with nivo AVD versus ADCETRIS AVD, and I believe they'll be presenting PFS data, but this is a curable disease. And we believe that the OS update with the ADCETRIS label will show that ADCETRIS is the favorite product at this time.

是的，當然。再次重申，這是 Seagen ADCETRIS 的分子，即 CD30 ADC。它已被批准用於治療移植後的何杰金氏淋巴瘤，並且目前已獲準用於治療先前未曾治療的何杰金氏淋巴瘤，合併使用化療、阿黴素、長春花鹼和達卡巴嗪。而且我們預計今年稍後該標籤將會針對整體存活率進行更新。現在，您所談論的數據來自 SWOG S1826 對 nivo AVD 與 ADCETRIS AVD 的研究，我相信他們將提供 PFS 數據，但這是一種可治癒的疾病。我們相信帶有 ADCETRIS 標籤的作業系統更新將表明 ADCETRIS 是此時最受歡迎的產品。

Our next question will come from Colin Bristow with UBS.

我們的下一個問題來自瑞銀的科林布里斯托。

Maybe first on danuglipron on the upcoming data. Could you just walk us through what the key efficacy and safety thresholds you're looking to meet to move this forward. And sort of with regards to those thresholds, how you think about them in light of that, this is BID dosing? And how does that potentially impact the sort of commercial opportunity. And then just second, a quick one on your DMD Phase 3 CIFFREO trial. You previously guided to completion of recruitment in April of this year. Just could you give us a quick update here, and then how you view the opportunity and positioning in light of the fact that there's a potential competitor approval at the end of this month?

也許首先會談到 danuglipron 即將公佈的數據。您能否向我們介紹您希望達到哪些關鍵功效和安全閾值才能推動這項進程。關於這些閾值，您如何看待它們，這是 BID 劑量嗎？這會對商業機會產生什麼潛在影響？其次，我想快速問一下您的 DMD 第三階段 CIFFREO 試驗。您之前曾指導在今年四月完成招募。您能否在這裡向我們簡要介紹最新情況，然後考慮到本月底可能獲得競爭對手的批准，您如何看待這個機會和定位？

Mikael?

米凱爾？

Yes. We are very excited about our 2 oral GLPs, the 1532 and danuglipron, 1532 called lotiglipron, and we are looking for a differentiated profile that will be a combination of rapid onset, high control of HbA1c, bringing it down and body weight loss at various doses to be very competitive and a more easily titrable drug that can optimize a preferred profile versus injectable when it comes to nausea and other well-known effects. So we look forward very much to data, maybe later this year or possibly early next year and cherry-pick the winner here. You also asked about DMD. Well, if there is an approval, it is based just on the surrogate markers. And in this area, I think it's very important to report out data when it comes to real patient benefit. And we expect possibly already late this year, alternatively next year to have data from the first randomized study that if positive could show favorable benefit for patients doing better according to the North Star scale. So we feel really positive about our own DMD program, and I think the entry will be competitive with the real data that patients need.

是的。我們對我們的兩種口服 GLP，1532 和 danuglipron 感到非常興奮，1532 稱為 lotiglipron，我們正在尋找一種差異化的產品，它將快速起效、高度控制 HbA1c、降低 HbA1c 和減輕體重相結合，各種劑量均可，具有較強的競爭力，並且是一種更容易的藥物因此，我們非常期待數據，也許是今年稍後或可能是明年年初，然後挑選出贏家。您也詢問了有關 DMD 的問題。嗯，如果獲得批准的話，那隻是基於替代標記。在這方面，我認為就真正的病人利益而言，報告數據非常重要。我們預計今年底或明年可能會有第一份隨機研究的數據，如果結果為陽性，則將顯示對根據北極星量表表現較好的患者有利。因此，我們對自己的 DMD 計畫充滿信心，我認為該計畫將與患者所需的真實數據具有競爭力。

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

我們的下一個問題來自美國銀行的傑夫·米查姆。

Just have 2. The first, Angela, on the I&I landscape, can you just talk about your expectations for category growth, just looking this year and next, just in light of the Humira and Stelara biosimilar to come. I'm asking just in the context for the etrasimod launch as well as Cibinqo. And then Albert, I know this question has been asked, but a different way though. I know you expect this year for COVID to be a down year, but when you think about your scorecard outside the U.S. with payers, as you've transitioned to commercial, what's been the initial feedback from a -- sort of from a price and volume perspective. Obviously, that's a key to your assumptions in 2024 and beyond.

只有 2 個問題。第一個，Angela，關於 I&I 形勢，您能否談談對類別增長的預期，展望今年和明年，考慮到即將推出的 Humira 和 Stelara 生物仿製藥。我只是想問有關 etrasimod 和 Cibinqo 的發布情況。然後阿爾伯特，我知道這個問題已經有人問過了，但方式不同。我知道您預計今年的新冠疫情將是低迷的一年，但是當您考慮您在美國以外的付款人的記分卡時，隨著您轉向商業化，從價格和數量的角度來看，最初的反饋是什麼。顯然，這是您對 2024 年及以後的假設的關鍵。

Let me answer the COVID question, and then Angela will answer the I&I landscape. We expect to have commercialization in the U.S., I think, likely the U.S. government will stop purchasing outside the normal (inaudible) products. We do not expect that to be the case in most of the countries international. We think that most of the countries will continue having governmental practices. And most of them, we have already long-term contract. So I don't think there will be much fluctuation over there in the price given the longevity of the product. When the products -- the contracts expire, of course, prices also will be adjusted. Now let's move to the question about I&I and Angela, please.

讓我回答有關 COVID 的問題，然後 Angela 會回答有關 I&I 的情況。我們預計在美國商業化，我認為，美國政府可能會停止購買正常（聽不清楚）以外的產品。我們不希望國際上大多數國家出現這種情況。我們認為大多數國家將繼續維持現有的政府做法。和他們中的大多數人，我們已經簽訂了長期合約。因此，考慮到產品的壽命，我認為價格不會有太大波動。當產品合約到期時，價格當然也會調整。現在我們來討論有關 I&I 和 Angela 的問題。

Sure. Well, I think to answer that question, you really have to look at each product and the specific disease that they're in. So let's start with etrasimod, which is UC. There, we believe that we have an advantage from a clinical profile perspective. We believe that we have the best-in-class S1B inhibitor, but there are also other great benefits such as the fact that it can be used steroid free, that we have convenient dosing. We also offer an oral option in a world that is very prevalent with injectables. And even with all of the assets out there, we still have 50% of people that have not achieved remission. So I think that the unmet need in UC is clear.

當然。嗯，我認為要回答這個問題，你必須真正了解每種產品及其適用的特定疾病。那麼就讓我們先從 etrasimod（潰瘍性結腸炎）開始吧。我們相信，從臨床概況的角度來看，我們具有優勢。我們相信我們擁有一流的 S1B 抑制劑，但還有其他巨大的優勢，例如它可以不使用類固醇，給藥方便。在註射劑盛行的當今世界，我們也提供口服藥物的選擇。即使我們投入了所有資源，仍有 50% 的人未能獲得緩解。所以我認為 UC 中未滿足的需求是顯而易見的。

And for us, in particular, given the profile of etrasimod, what we think is the greatest opportunity for us is in earlier lines of treatment, where there has not been as much advancement, right? There's a lot of anti-TNF. There's a lot of biosimilars, there's JAKs, there's other mechanisms. But in earlier lines of treatment, there really is not enough. And so that's where we think we have an opportunity to meet an underserved need today, and that's where we're going to be -- that's where we're going to be positioning etrasimod. Ritlecitinib is a different story. When you look at that particular indication for alopecia that is really an underdeveloped market.

對我們來說，特別是考慮到 etrasimod 的特性，我們認為最大的機會是在早期的治療方法中，而這一領域還沒有取得太大的進展，對嗎？存在大量抗 TNF。有很多生物相似藥、JAK 和其他機制。但在早期治療中，這確實是不夠的。所以，我們認為我們今天就有機會滿足尚未得到充分服務的需求，這也是我們要定位 etrasimod 的地方。利曲替尼則是另一個情況。當您查看脫髮的具體指徵時，這實際上是一個尚未開發的市場。

There's 3 million people today, there are no great options for adults. And there are absolutely no options for adolescents and children. And so the profile that we have with ritlecitinib is a -- it's the best-in-class JAK. It's the best JAK. And I think that we're going to compete well in addition to the fact that we're going to be the only JAK compared to ritlecitinib that has an indication for adolescents. So I think in this regard, because it's a new disease or a highly undeserved disease, I think education and awareness, education at the level of the prescriber, the patient but also with the payers is going to be key to our ability to access this market.

如今人口有 300 萬人，對成年人來說沒有很好的選擇。對於青少年和兒童來說，根本沒有其他選擇。因此，我們對 ritlecitinib 的特性的評價是 — — 它是同類最佳的 JAK。這是最好的 JAK。我認為，我們將在競爭中取得良好成績，此外，與利曲替尼相比，我們是唯一適用於青少年的 JAK 藥物。因此我認為在這方面，因為這是一種新疾病或一種極不值得治療的疾病，我認為教育和認識，在處方人員、患者以及付款人層面的教育將是我們進入這個市場的關鍵。

Thank you. And of course, considering these all the time.

謝謝。當然，我們始終都會考慮這些。

Our next question comes from Trung Huynh with Crédit Suisse.

下一個問題來自瑞士信貸的 Trung Huynh。

Trung Huynh from Crédit Suisse. I have 2, if I can. So first one, a few days ago, you saw the FDA Advisory Committee vote on Lynparza's PROpel trial. In that, the committee voted against the approval in all comers. So for TALZENNA and TALAPRO-2, what's your expectations for your label here given the strength of your data. And could that affect your $1 billion peak sales number that you gave in December. And then for the RSV flu co-administration study, what flu vaccine did you test that with, is at the high dose or the low dose? And if it's the low dose, could you be approved for use with the high dose, which is more relevant today.

來自瑞士信貸銀行的 Trung Huynh。如果可以的話，我有 2 個。首先，幾天前，您看到 FDA 諮詢委員會對 Lynparza 的 PROpel 試驗進行了投票。委員會對所有贊成票均投了反對票。那麼對於 TALZENNA 和 TALAPRO-2，考慮到您的資料強度，您對標籤的期望是什麼。這會影響您在 12 月給出的 10 億美元高峰銷售數字嗎？然後，對於 RSV 流感共同給藥研究，您使用哪種流感疫苗進行了測試，是高劑量還是低劑量？如果是低劑量，是否可以批准使用高劑量，這在今天更為重要。

Thank you very much. William, would you like to take the TALAPRO part question?

非常感謝。威廉，你願意回答 TALAPRO 部分的問題嗎？

Yes, sure. So thanks for the question. So as Mikael said, the study showed with enzalutamide plus TALAPRO -- TALZENNA versus enza, we showed a 37% reduction in the radiographic progression-free survival. Notably, in the same presentation, we also showed a hazard ratio in the HR deficient population of 0.48, a significant p-value. And then in the HRR non-deficient unknown population, HR of 0.7 with the p-value of 0.004. So we remain confident about our data in the all-comer population. Obviously, we can't compare to PROpel. Notably, in TALAPRO-2, we had prospective testing for HRR deficiencies, including BRCA1 and 2. I also want to point out that our control arm of XTANDI reaffirms XTANDI is best-in-class NHT for the indication with a radiographic PFS of 22 months. And in the treatment on the TALA, our PFS was not reached. So we expect that the HR population, which is 25% will be compelling with the data. And we'll also continue to present additional data in the HR subpopulation at ASCO in 2023. And notably, we did get priority review, and we're currently in registration.

是的，當然。感謝您的提問。正如米凱爾所說，研究表明，使用恩雜魯胺加 TALAPRO（TALZENNA 與恩雜魯胺相比），放射學無惡化存活期減少了 37%。值得注意的是，在同一演示中，我們還顯示了 HR 缺陷人群的風險比為 0.48，這是一個顯著的 p 值。然後在 HRR 非缺陷的未知族群中，HR 為 0.7，p 值為 0.004。因此，我們對所有來訪人群的數據仍然充滿信心。顯然，我們無法與 PROpel 相比。值得注意的是，在 TALAPRO-2 中，我們對 HRR 缺陷進行了前瞻性測試，包括 BRCA1 和 2。我還想指出，我們的 XTANDI 對照組再次證實 XTANDI 是同類最佳的 NHT 藥物，其放射學 PFS 為 22 個月。而在TALA治療中，我們的PFS並未達到。因此，我們預計 25％ 的人力資源人員將對數據產生興趣。我們也將在 2023 年的 ASCO 上繼續展示更多 HR 亞群的數據。值得注意的是，我們確實獲得了優先審查，目前正在進行註冊。

Thank you, William. And Mikael, about RSV and flu.

謝謝你，威廉。還有 Mikael，關於呼吸道合胞病毒和流感。

Yes. We are extremely excited about the RSV vaccine, and we'll provide data on co-administration of that vaccine with adjuvanted flu. We expect it to be available and generalized to all flu vaccines. And then when it comes to longer term, we also are already in combination study with our RSV and using our internal portfolio of COVID and mRNA flu. So we see this as a developing a very strong portfolio this year with core administration opportunities next year, possibly our own flu vaccine and then combination thereof. So stay tuned.

是的。我們對 RSV 疫苗感到非常興奮，我們將提供該疫苗與佐劑流感疫苗共同給藥的數據。我們希望它能夠普及到所有流感疫苗。從長期來看，我們也已經在與 RSV 進行聯合研究，並使用我們內部的 COVID 和 mRNA 流感產品組合。因此，我們認為今年我們將開發一個非常強大的產品組合，明年我們將擁有核心的管理機會，可能會有我們自己的流感疫苗，然後是兩者的組合。敬請關注。

Next question will come from Andrew Baum with Citi.

下一個問題來自花旗的 Andrew Baum。

Just coming back to the -- your oral GLP-1 portfolio. Lilly has called out an anticipated weight loss at 32 weeks from memory of around 14%, 15%. And they hesitate to give baseline. Given the competitive nature of the field, you're late to market and the cost of running CVOT trials in this setting. Where does the relative weight loss need to be from your Phase 2 for you to advance given the benchmark that Lilly seems to be setting?

回到—您的口服 GLP-1 產品組合。禮來公司預計，根據記憶，32 週時體重會減輕約 14% 至 15%。他們不願意給出底線。考慮到該領域的競爭性質，您會遲遲沒有進入市場，而且在這種環境下進行 CVOT 試驗的成本也很高。考慮到 Lilly 設定的基準，從第 2 階段開始您需要減輕多少體重才能取得進展？

That's a good question for Mikael. Mikael?

這對米凱爾來說是個好問題。米凱爾？

Yes. No, we agree completely with you that we should have an ambitious profile, and we have certainly seen in patients up to 15% weight loss depending on different dose regimens. So for obesity, that's a really good ambition to have up to 15%. And for diabetes patients, of course, it's about having a very strong HbA1c lowering, maybe 2% or even more, so we think it's feasible with orals, and we think that will open up a very large place, and we think that pending data readout that we may have a differentiated profile for our full agonists.

是的。不，我們完全同意您的觀點，我們應該有一個雄心勃勃的目標，而且我們確實看到，根據不同的劑量方案，患者的體重減輕了 15%。因此對於肥胖症而言，將肥胖率提高到 15% 是一個非常好的目標。對於糖尿病患者來說，當然，這意味著要非常有效地降低 HbA1c，可能降低 2% 甚至更多，因此我們認為口服藥物是可行的，而且我們認為這將開闢一個非常廣闊的空間，我們認為，在等待數據讀出後，我們可能會對我們的完全激動劑有一個差異化的特徵。

Thank you, Mikael. So we are waiting to see the data that I will speak.

謝謝你，米凱爾。所以我們正在等待看我將要講述的數據。

Next, we have Chris Schott with JPMorgan.

接下來是摩根大通的克里斯·肖特 (Chris Schott)。

Just 2 questions for me. Maybe first on the capital allocation comments. I guess the more balanced capital allocation post the SGEN de-levering. Just on that front, where do we need to see leverage go to before we can think about that balanced allocation? And in the meantime, what is the capacity and appetite for further deals? So can we think about kind of Biohaven size deals while you're de-levering from Seagen, or is it really smaller transactions? And then my second question was just one on RSV market development. Just how quickly do you see this market developing? I guess I'm just trying to get my hands around how much education this requires, and do you worry at all about vaccine fatigue, I guess, just given all the boosters that this population, I guess, received during the pandemic, does that slow at all the uptake versus kind of a normalized environment?

我只有兩個問題。也許首先要談的是資本配置評論。我猜 SGEN 去槓桿後資本配置會比較均衡。就這方面而言，我們需要看到槓桿率達到什麼水平，然後我們才能考慮平衡分配？同時，進一步達成交易的能力和意願又如何呢？那麼，當您從 Seagen 去槓桿時，我們可以考慮類似 Biohaven 規模的交易嗎，還是說這些交易規模真的很小？我的第二個問題是關於 RSV 市場開發的問題。您認為這個市場發展得有多快？我想我只是想弄清楚這需要多少教育，你是否擔心疫苗疲勞，我想，考慮到這個群體在疫情期間接種的所有加強針，與正常化環境下相比，這是否會減緩疫苗接種的速度？

Good questions, Chris. Dave, capital allocation.

很好的問題，克里斯。戴夫，資本配置。

Yes. So thank you, Chris, for the question. Obviously, we have invested heavily back into our business here's all with the focus of growing our business from -- both from a top line perspective, but importantly, from a bottom line perspective. And I think now as we begin to cycle into I'll say, post the peak of this reinvestment in the business, we should begin to harvest, if you will, some of the cash flows coming out of the investments that we made and capitalize, if you will, on the returns that we expect out of these investments.

是的。所以謝謝你，克里斯，提出這個問題。顯然，我們對我們的業務進行了大量的投資，這一切都是為了從業務角度發展我們的業務——不僅從營收角度，而且更重要的是從利潤角度。我認為現在我們開始進入周期，我會說，在業務再投資達到頂峰之後，我們應該開始收穫我們所做投資產生的部分現金流，並利用我們預期從這些投資中獲得的回報。

So having said that, we expect, because of that, we should get ourselves back more balanced into the 3 pillars, again, reinvesting back in our business, growing our dividend and doing value-enhancing share repurchases. From a leverage perspective, obviously, we want to maintain our high investment-grade rating in access to Tier 1 commercial paper, that would say that we would probably be in the low 3x levered ZIP code from that perspective. And then from an M&A perspective, we're still active in the M&A market. Obviously, first and foremost, on our objective now is to close and begin to integrate Seagen, so that's priority #1. Having said that, we will still look at the M&A marketplace, understand if there's assets that meet our criteria to supplement our business and we could theoretically execute against that given our capital structure. Having said that, in the near term, those will probably be smaller, little tuck-in type deals given our leverage ratio in the very near term.

因此，話雖如此，我們期望，正因為如此，我們應該重新平衡三大支柱，再次對我們的業務進行再投資，增加我們的股息，並進行增值的股票回購。從槓桿率的角度來看，顯然，我們希望在獲得一級商業票據方面保持我們的高投資級評級，從這個角度來看，這意味著我們可能處於低 3 倍槓桿郵政編碼中。從併購的角度來看，我們仍然活躍於併購市場。顯然，我們現在的首要目標是完成並開始整合 Seagen，所以這是第一要務。話雖如此，我們仍將關注併購市場，以了解是否有符合我們標準的資產來補充我們的業務，並且理論上我們可以在我們的資本結構下執行這些資產。話雖如此，但考慮到我們近期的槓桿率，短期內這些交易可能規模較小，是小型合併類型的交易。

Thank you, Dave. Angela, what about RSV and the educational efforts that the market would mean.

謝謝你，戴夫。安吉拉，RSV 和市場對教育的貢獻又如何呢？

Well, with all launches, education is really important. And that's why we've already begun our unbranded disease education with physicians, laying the groundwork for the importance of vaccinating with or vaccinating for RSV. But of course, with all launches and with all new diseases and education is important to consumers, it's important to caregivers, to payers. And so on all of those fronts, those discussions have either begun or are beginning, and we plan to obviously implement a robust market development plan like we do for all of our vaccines. However, I think that the biggest advantage here is in the synergies of RSV together with our other adult vaccines, right? We have not 20 adults. We've had COVID. We -- all of these vaccines follow a very similar pattern in terms of the commercial needs that they have.

嗯，對於所有的發布來說，教育都非常重要。這就是為什麼我們已經開始對醫生進行非品牌疾病教育，為接種呼吸道合胞病毒疫苗的重要性奠定基礎。但當然，對於所有的新產品和新疾病來說，教育對消費者、照護人員和付款人來說都很重要。因此，在所有這些方面，這些討論要么已經開始，要么即將開始，我們計劃實施強有力的市場開發計劃，就像我們針對所有疫苗所做的那樣。不過，我認為這裡最大的優勢是 RSV 與我們其他成人疫苗的協同作用，對嗎？我們沒有20名成年人。我們感染了 COVID。我們—所有這些疫苗在商業需求方面都遵循非常相似的模式。

And I think that we have the opportunity to quickly and seamlessly bring RSV on into our portfolio and use the very same approaches and mechanisms and the same conversations that whether it's with a retailer, whether it's a payer, whether it's with our point of vaccinations to bring RSV on. So actually, I think that this is a very exciting time, and we feel very confident about the ability to seamlessly introduce RSV as another vaccine in our respiratory portfolio.

我認為我們有機會快速無縫地將 RSV 納入我們的產品組合，並使用相同的方法和機制以及相同的對話，無論是與零售商、付款人還是我們的疫苗接種點，都將 RSV 納入其中。因此實際上，我認為這是一個非常令人興奮的時刻，我們對無縫引入 RSV 作為我們呼吸道產品組合中的另一種疫苗的能力非常有信心。

Our next question comes from David Risinger with SVB Securities.

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

First, could you discuss the PAXLOVID private market sales potential in China after March 31 that isn't included in your PAXLOVID guidance for the year? And also, could you comment on the late-stage competitive threats from Sanofi's 21-valent pneumococcal conjugate vaccine in adults and infants and Merck's 21-valent in adults.

首先，您能否討論一下 3 月 31 日之後 PAXLOVID 在中國私募市場的銷售潛力，而這並未包含在您今年的 PAXLOVID 指導中？另外，您能否評論一下賽諾菲針對成人和嬰兒的21價肺炎球菌結合疫苗以及默克針對成人的21價疫苗的後期競爭威脅？

Thank you. Angela, PAXLOVID equity in private market in China?

謝謝。 Angela，PAXLOVID股權在中國私募市場中佔有一席之地嗎？

Sure. So after April, we are -- we continue to have PAXLOVID available, and -- but it will be accessed through an out-of-pocket payment mechanism. So if you're a private patient, you can get it, if you're a public patient, you can get it, you just need to be able to pay out of pocket for it. And we intend to continue to work with the public and with the Chinese government to ensure its access.

當然。因此，四月之後，我們將繼續提供 PAXLOVID，但需透過自付費用機制才能使用。因此，如果您是私人病人，您就可以獲得它；如果您是公立病人，您也可以獲得它，您只需要自掏腰包即可。我們打算繼續與公眾和中國政府合作，確保其能夠取得版權。

We can't give now guidance for a particular product in a particular country. So but -- Angela explained the dynamics. Mikael, very quickly on the competition of pneumococcal.

我們現在無法針對某個國家/地區的某種特定產品提供指導。但是——安吉拉解釋了動態。米凱爾很快就對肺炎球菌的競爭做出了反應。

Yes, I mean, we are extremely excited about the PCV20 recent pediatric approval with a stellar labor, reflecting the strength of our data. We monitor carefully competitor activity, as you alluded to and are planning ourselves to enter next year, further expanded PCV vaccines, followed by additional expansion a few years later, including optimization of the conjugation procedures, including different carriers and possibly for the adult also adjuvants that we think could be useful. So this is a market where we have been the leaders. We have a unique platform. And we monitor and feel very confident that we are going to have a bright future, although you mentioned competitor which is a nature of markets that are becoming, of course, more saturated like the adult market. But there, we also hope to benefit from our broader portfolio of respiratory vaccines from COVID flu RSV that cannot be matched by others at the moment.

是的，我的意思是，我們對 PCV20 最近獲得兒科批准感到非常興奮，這是一項出色的工作，反映了我們數據的實力。正如您所提到的，我們密切關注競爭對手的活動，並計劃明年進一步擴大 PCV 疫苗，幾年後再進行進一步擴大，包括優化結合程序，包括不同的載體，以及可能對成人有用的佐劑。所以在這個市場上我們一直處於領先地位。我們擁有獨特的平台。儘管您提到了競爭對手，但我們正在監控並非常有信心我們將擁有光明的未來，當然，這是市場性質的體現，就像成人市場一樣，市場正變得越來越飽和。但是，我們也希望從我們更廣泛的 COVID 流感 RSV 呼吸道疫苗組合中受益，這是目前其他疫苗無法比擬的。

Our next question will come from Steve Scala with Cowen.

我們的下一個問題來自 Cowen 的 Steve Scala。

I have 2 follow-ups. First, on pneumococcal vaccine. So Pfizer just started a study of a vaccine, including a new ingredient. Is the new ingredient an adjuvant? Is it more valent, or is it something else? And then a follow-up on the OPDIVO versus ADCETRIS study. Can you say whether you are aware of the data at the time of announcing the Seagen acquisition? And why should we not view this as a significant risk.

我有 2 個後續行動。第一、關於肺炎鏈球菌疫苗。因此輝瑞公司剛開始研究一種疫苗，其中包括一種新成分。這種新成分是佐劑嗎？它是否更有價值，或有其他什麼？然後對 OPDIVO 與 ADCETRIS 的研究進行追蹤。您能否說一下在宣布收購 Seagen 時是否了解這些數據？為什麼我們不應該將此視為重大風險？

Thank you. Mikael, what is the secret ingredient?

謝謝。米凱爾，秘密配方是什麼？

The secret sauce in this particular trial is a new adjuvant that we think could play a potential nice role in the PCV adult market as you go to increasing valency in this space. As I said before, in parallel, we are working on -- looking at different carriers, different chemistries and we'll shortly reveal for next year a start of a broader expanded PCV vaccine that will incorporate all these learnings. So stay tuned.

這項試驗的秘密武器是一種新的佐劑，我們認為隨著該領域的療效不斷提高，這種佐劑可能在 PCV 成人市場中發揮潛在的良好作用。正如我之前所說，與此同時，我們正在研究不同的載體、不同的化學成分，我們很快就會公佈明年開始推出更廣泛的 PCV 疫苗，該疫苗將結合所有這些研究成果。敬請關注。

And William, on the -- again, on the OPDIVO study.

威廉，再次談論 OPDIVO 研究。

Yes, sure. So again, on the OPDIVO study, that SWOG study has been ongoing for a while. We were not aware of the data that's going to be presented at ASCO. I would reiterate again, it's early PFS data from what we can see and the most important measure of activity in Hodgkin's lymphoma would be overall survival. And again, we expect Seagen to get an updated label showing overall survival benefit in first-line Hodgkin's lymphoma.

是的，當然。再次強調，關於 OPDIVO 研究，SWOG 研究已經進行了一段時間。我們不知道在 ASCO 上將會展示什麼數據。我再次重申，這是我們所能看到的早期 PFS 數據，而霍奇金淋巴瘤最重要的活動指標是整體存活期。我們再次期望 Seagen 能夠獲得更新的標籤，顯示其在霍奇金淋巴瘤一線治療中的整體存活獲益。

Our next question will come from Kerry Holford with Berenberg.

我們的下一個問題來自 Berenberg 的 Kerry Holford。

Two questions on the RSV vaccine, please. Firstly, on the older adult vaccine. On Slide 22, you note emerging mid-second season data supporting durable efficacy. I wonder if you can elaborate a little more here on patent you have in hand today, and you want to act to get that second-season data in front of the FDA approval. And assuming you do see protection into that second season, how might that imply your pricing in the U.S.? And then secondly, on the maternal vaccine, you have had launch schedule in Q4 on Slide 6 and it implies that, that may not happen until the first quarter of next year. So could you just provide more clarity on when you could launch a maternal vaccine.

請問兩個關於 RSV 疫苗的問題。首先，關於老年人疫苗。在投影片 22 上，您可以注意到第二季中期出現的數據支援持久的療效。我想知道您是否可以在這裡詳細說明您現在手中的專利，以及您想要採取行動以便在 FDA 批准之前獲取第二季的數據。並且假設您確實看到第二季受到保護，這對您在美國的定價有何影響？其次，關於孕產婦疫苗，您在第 6 張投影片中列出了第四季度的發佈時間表，這意味著可能要到明年第一季才會推出。那麼您能否更清楚說明何時可以推出孕產婦疫苗。

Yes. Mikael, what about the RSV vaccine?

是的。米凱爾，RSV 疫苗怎麼樣？

Yes. We were very pleased to get our first data chunk from second season, mid-season data for older adults, and it clearly shows that robust data that we shared, for example, we shared high 80% reduction in lower respiratory tract infections with 3 symptoms. We see also on this and similar on other end point a very robust, very meaningful protection also in the second season. Now as you know, at the same time, we are preparing for the future combination vaccines, and we think, in general, that you will see an evolution in the adult market with simplified vaccination schedule, annual revaccination of COVID flu RSV. For those that, for some reason, miss a vaccination, we think, the second season data will be very good. On the maternal, we are preparing for an advisory committee, we think we have great data. We are the only one that have been able to conclude a maternal vaccination. We're the only one that we're able to construct an RSV vaccine without using an adjuvant, and we think it's a differentiated product. And I assume it will be soon after a potential approval, ACIP, and opportunity for Angela to launch to a very eagerly awaiting community of increasingly attentive pregnant women and maternal clinics to protect the newborn.

是的。我們非常高興獲得了第二季的第一批數據，即老年人的中期數據，它清楚地顯示了我們共享的可靠數據，例如，我們共享了具有 3 種症狀的下呼吸道感染減少了 80% 以上。我們還在第二季中看到了這一點以及類似的其他終點的非常強大、非常有意義的保護。如您所知，與此同時，我們正在為未來的聯合疫苗做準備，總的來說，我們認為，您將看到成人市場演變，包括簡化的疫苗接種時間表、每年重新接種 COVID 流感 RSV 疫苗。對於那些因為某些原因而錯過接種疫苗的人，我們認為第二季的數據會非常好。在產婦方面，我們正在籌備一個諮詢委員會，我們認為我們擁有大量數據。我們是唯一能夠完成母體疫苗接種的國家。我們是唯一一家能夠在不使用佐劑的情況下製造 RSV 疫苗的公司，我們認為這是一種差異化產品。我認為，在獲得潛在批准、ACIP 和 Angela 有機會向越來越關注孕婦和產婦診所的熱切期待的社區推出保護新生兒的服務後，很快就會有這樣的機會。

Thank you, Mikael. As we said -- as we have in our slide, we expect to be approved in this year in the last quarter. So it will launch. We expect the publication of the MMWR likely to happen at the beginning of the next year. So that plays also a key role in the uptake of the vaccine. But keep in mind, the launch of vaccine starts before the approval, right? We have done a lot of educational efforts and there are a lot of investments that we are doing in that field. So in that aspect, the launch already has started from our side at least.

謝謝你，米凱爾。正如我們在幻燈片中所說，我們預計該提案將在今年最後一個季度獲得批准。因此它將會啟動。我們預計 MMWR 可能會在明年年初發布。因此，這對於疫苗的採用也起著關鍵作用。但請記住，疫苗的推出是在批准之前就開始的，對嗎？我們在教育領域做了很多努力，並且在該領域進行了大量投資。所以從這個方面來看，至少從我們這邊來說，記者會已經開始了。

Next question will come from Carter Gould with Barclays.

下一個問題來自巴克萊銀行的卡特·古爾德。

I guess first on the decision to establish a new operating segment and specifically launched this Pfizer Ignite offering. Can you talk about what drove that? And if there's sort of like an aspirational target and how meaningful of a driver that could be? And then secondly, sort of on the decision to divest BAVENCIO. Did that reflect sort of a signal you got from FTC or a proactive move in your mind? Or are there other factors we should think about and the fact that we haven't seen other divestments to that, should that reinforce our confidence that you think that the deal can go through without other issues?

我想首先要決定建立一個新的營運部門，並專門推出輝瑞 Ignite 產品。你能談談造成這現象的原因嗎？如果有一個理想的目標，那麼這個目標對於推動其發展有多大意義？其次，關於剝離 BAVENCIO 的決定。這是否反映了您從聯邦貿易委員會收到的某種訊號，還是您心中採取的主動舉措？或者我們還應該考慮其他因素，而且我們還沒有看到其他撤資行為，這是否應該增強我們的信心，您認為該交易可以在沒有其他問題的情況下順利完成？

Thank you very much. On the Bavencio question, the discussions to return the rights for royalties -- in exchange for royalties had started well before Seagen, so it has nothing to do with the acquisition of Seagen. It was something that was ongoing between us and Merck Serono for the benefit of the product and for (inaudible), just was completed after we announced the deal shortly after, but it had started way, way before. Aamir, would you like also to explain the Ignite business?

非常感謝。關於 Bavencio 的問題，以版稅換取權利的討論早在 Seagen 之前就開始了，所以這與收購 Seagen 無關。這是我們與默克雪蘭諾公司之間為了產品利益而正在進行的一項工作，並且（聽不清楚）在我們宣布交易後不久就完成了，但它早在之前就已經開始。阿米爾，您也想解釋一下 Ignite 業務嗎？

Yes, Carter, thanks for the question. I think you've seen us collaborate with the biotech ecosystem in lots of different ways, and Pfizer Ignite is another way in which we can effectively do that. Frankly, there's a lot of interest and demand on the part of particularly biotechs for working with us to access some of our distinctive research and clinical development capabilities, and we think Ignite gives us a platform to do that, to work with these companies, get closer to the science, which over time also then improves our ability to access that science and make determinations about what we would like to bring in-house. So we think this is an excellent way for us to continue to collaborate with the biotech ecosystem and add to our growing and compelling pipeline overtime.

是的，卡特，謝謝你的提問。我想您已經看到我們以多種不同的方式與生物技術生態系統合作，而輝瑞 Ignite 是我們可以有效地做到這一點的另一種方式。坦白說，特別是生物技術公司對與我們合作以獲取我們一些獨特的研究和臨床開發能力表現出很大的興趣和需求，我們認為 Ignite 為我們提供了一個平台來做到這一點，與這些公司合作，更接近科學，隨著時間的推移，這也會提高我們獲取科學的能力，並決定我們想要在內部引入什麼。因此，我們認為這是繼續與生物技術生態系統合作並隨著時間的推移增加我們不斷增長且引人注目的產品線的絕佳方式。

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

我們的下一個問題來自高盛的 Chris Shibutani。

On PAXLOVID, the U.S. commercial opportunity, can you update us on any framing of what you're thinking in terms of pricing and when we will know that. And in particular, with the commercial availability, are you anticipating much in the way of sort of payer engagements in terms of thinking about how that process will unfold utilization management wise. And then on the business development front, if we go to the $30 billion that you had outlined for a while now and think about what is remaining from that unadjusted target in terms of 2030 revenues let's say, approximately $5 billion is left. As we're thinking about how you guys are contemplating what areas to go into in terms of verticals or therapeutic areas or modalities, would it be fair to expect that at this stage, a consideration might be to minimize the extent that you would have to rebuild or sort of refurbish on the SI&A front, given your margin objectives longer term?

關於 PAXLOVID 這個美國商業機會，您能否向我們介紹一下您對定價的想法以及我們何時能知道價格。特別是，隨著商業可用性的提高，您是否期待在考慮該流程將如何從利用管理角度展開方面以某種付款人參與的方式進行？然後在業務發展方面，如果我們按照您之前概述的 300 億美元來計算，並考慮一下就 2030 年的收入而言，該未調整目標還剩下多少錢，假設還剩下大約 50 億美元。當我們思考你們如何考慮在垂直行業、治療領域或治療方式方面進入哪些領域時，是否可以公平地預期，在現階段，考慮到你們長期的利潤目標，可能會考慮盡量減少你們在 SI&A 方面重建或翻新的程度？

Angela, on PAXLOVID commercialization.

安吉拉 (Angela) 談 PAXLOVID 商業化。

Sure. So Chris, yes, we're preparing for launch now. But as we've said, we've shared before, the date of launch and exactly how that's going to happen is still very much subject to our discussions with the U.S. government. So we're going to align with guidance from them in terms of how that's going to happen. Of course, in the meantime, we are preparing for the commercialization of PAXLOVID and payer discussions around the world is critical. So those have begun. Obviously, it's too early for me to share the price of PAXLOVID. But suffice to say that the price ranges that we have brought to our payers together with the value argument that we have been able to develop through robust real-world evidence from the number of hospitalizations, the number of deaths that we've been able to avert through the treatment with PAXLOVID is very much supportive of the pricing ranges that we're talking about. So I think very soon, we'll be able to share more.

當然。所以克里斯，是的，我們現在正在準備發射。但正如我們之前所說，發射日期以及具體如何進行仍然取決於我們與美國政府的討論。因此，我們將遵循他們的指導，以了解如何實現這一目標。當然，與此同時，我們正在為PAXLOVID的商業化做準備，世界各地的付款人討論至關重要。這些已經開始了。顯然，現在分享PAXLOVID 的價格還為時過早。但可以說，我們為付款人提供的價格範圍，以及我們透過住院人數、透過使用 PAXLOVID 治療能夠避免的死亡人數等強有力的現實證據得出的價值論據，非常支持我們正在討論的價格範圍。因此我認為很快我們就能分享更多。

And Aamir, about -- what is the profile of future BD activities?

那麼阿米爾，未來 BD 活動的概況是怎麼樣的呢？

Yes, Chris, as you mentioned, we have a goal of $25 billion in risk-adjusted revenue by 2030. And I should remind everyone that is a 2030 goal. We -- with the deals that we've done, have a remaining balance of less than $5 billion against that goal. And I think our strategy to pursue that is going to be consistent with what we have employed to date. First and foremost, it's going to be about compelling science that we can add value to. That's also going to contribute growth in the 25 to 30 period and take lots of things into consideration, including the impact on the P&L profile. So that will continue to be our focus, and we'll continue to be disciplined in the opportunities that we look for. And as Dave mentioned earlier, our priority right now is ensuring that we close out and successfully integrate the Seagen transaction as well as drive value from the other deals that we've done, and we'll continue to actively look for opportunities.

是的，克里斯，正如您所說，我們的目標是到 2030 年實現 250 億美元的風險調整後收入。我應該提醒大家，這是 2030 年的目標。透過我們已經達成的交易，我們距離這一目標還剩不到 50 億美元。我認為我們追求的策略將與我們迄今為止所採用的策略保持一致。首先，這將是關於令人信服的科學，我們可以為其增加價值。這也將有助於 25 至 30 年期間的成長，並考慮許多因素，包括對損益狀況的影響。因此，這將繼續成為我們的重點，我們將繼續嚴謹地尋找我們所尋找的機會。正如戴夫之前提到的，我們現在的首要任務是確保完成並成功整合 Seagen 交易以及從我們所做的其他交易中獲取價值，我們將繼續積極尋找機會。

Thank you, and we are a bit out of time, so last question, please.

謝謝，時間有點不夠了，所以請問最後一個問題。

Our last question will come from Tim Anderson with Wolfe Research.

我們的最後一個問題來自 Wolfe Research 的蒂姆·安德森。

A couple of questions. The first is, how much of your future COVID vaccine revenue forecast are tied to the ability to have the combination product if something like mRNA flu ends up not being viable and knocked out of flu COVID combo, would that impact your anticipated uptake in 2025 and beyond? Or can you get to those longer-term guidance levels, regardless of whether you have any combos or not. And then last question, Albert, I'm guessing there's some frustration among management with what the stock has been doing a tough 2023, 2022 wasn't a great year. This is despite Pfizer helping lead the world out of the pandemic, which was a remarkable accomplishment, even today, beat consensus, stock is down a little bit. So as you talk to analysts and investors, what are you hearing are the biggest concerns that you think could explain this? And what do you think analysts, investors are missing or misunderstanding?

幾個問題。首先，您對未來 COVID 疫苗收入的預測有多少與組合產品的能力有關，如果像 mRNA 流感這樣的疫苗最終變得不可行並被排除在流感 COVID 組合之外，這會影響您對 2025 年及以後的預期吸收量嗎？或無論您是否擁有任何組合，您均能達到那些長期指導水準。最後一個問題，阿爾伯特，我猜管理層對股票在 2023 年的艱難表現感到有些沮喪，因為 2022 年並不是很好的一年。儘管輝瑞幫助世界擺脫了疫情，這是一個了不起的成就，但即使在今天，其股價仍略有下跌。那麼，當您與分析師和投資者交談時，您聽到的最大擔憂是什麼？您認為這可以解釋什麼？您認為分析師和投資人忽略了什麼或誤解了什麼？

Thank you, Tim. Let me start with the first one. We do expect that if there are successful combinations with flu, that will drive utilization of the COVID vaccine much higher. As you know, we now in our estimation should we expect, for example, in the U.S. around 24%, 25% in the next few years of, COVID, the vaccine. The flu right now utilization around 50%. So there is a big gap. So that's why we believe that the combination between flu and COVID will arise also to the COVID and eventually potentially we can call the way up to the same utilization like flu, particularly given that there are no copays approved and recommended vaccines. Now as regards to the frustration, for the 2023, clearly, I believe that the stock price right now does not reflect the value that Pfizer has.

謝謝你，提姆。讓我從第一個開始。我們確實預計，如果與流感疫苗成功結合，將會大大提高 COVID 疫苗的利用率。如您所知，我們現在估計，在未來幾年內，美國 COVID 疫苗的接種率應約為 24%、25%。目前流感利用率約50%。因此差距很大。因此，我們相信流感和新冠肺炎的組合也會出現在新冠肺炎中，最終我們有可能將其發展成與流感相同的感染方式，特別是考慮到目前還沒有批准和推薦的疫苗共同支付。現在談到 2023 年的挫折感，顯然，我認為目前的股價並不能反映輝瑞的價值。

The fact that we are so proud because of our contribution in saving the world, I don't think, that we expect the stock price increases because of that. We did it because it was the right thing to do. And I think we are very, very proud of that. But we expect to see stock price increases as we are executing our plan, which is to create sustainable top line revenue growth that will allow us to leverage the bottom line, that will grow faster than the top line. And I think we articulated the plan about that and that plan was to invest in acquiring good scientific substrate that will allow us to launch products that will give us $25 billion revenues by year 2030, and we have done tremendous progress on that by having already according to our calculations of $20 billion.

事實上，我們為自己為拯救世界所做的貢獻而感到自豪，但我認為，我們並不會因此而期望股價會上漲。我們這樣做是因為這是正確的做法。我認為我們對此感到非常非常自豪。但我們預計，在執行計劃的過程中，股價將會上漲，該計劃旨在創造可持續的營收成長，使我們能夠利用利潤，實現比營收更快的成長。我認為我們已經明確了相關計劃，即投資獲取良好的科學基礎，使我們能夠推出到 2030 年能為我們帶來 250 億美元收入的產品，而且我們在這方面已經取得了巨大進展，根據我們的計算，我們的收入已經達到了 200 億美元。

We are also invested in R&D in the last -- in the past few years, and we have now an unprecedented launch of new products. And I think the Street is expecting to see how those launches will evolve. Clearly, I think there is over hand -- over the COVID revenues. There is uncertainty if the COVID revenues will materialize. We don't have any precedents to show that we know how to predict it well. So our predictions are based on epidemiological science. And based on trends that we are testing with market people. So I think that from my perspective, what I said, we are very committed to creating value for the shareholders. We know that everything we do, we do it with their money. It's not our money. And we want to be very good stewards of that. So it's not enough to save the world, I think also, we need to increase the stock price. We are highly committed to do that. We are explaining, better the strategy more importantly, executing on it.

我們在過去幾年也對研發進行了投資，現在我們推出了前所未有的新產品。我認為華爾街正在期待看到這些產品的發布將如何發展。顯然，我認為 COVID 收入有超額現象。目前還不確定 COVID 收入是否會實現。我們沒有任何先例表明我們知道如何很好地預測它。所以我們的預測是基於流行病學科學的。並且基於我們與市場人員一起測試的趨勢。因此我認為，從我的角度來看，我們非常致力於為股東創造價值。我們知道，我們所做的一切都是用他們的錢做的。這不是我們的錢。我們希望能很好地管理好這一點。所以拯救世界是不夠的，我認為我們還需要提高股價。我們非常致力於做到這一點。我們正在解釋，改進戰略，更重要的是執行它。

So with that, I think it gave me also seem a good segue to close. In summary, we believe that, that was a solid quarter. We delivered on our commitments. We exceeded actual expectations from the Street. And we will continue doing so with the compass, but we will create serious value for patients. And that we are certainly will translate into value for shareholders. We are executing our plan, and we will remain very committed to doing that.

因此，我認為它也為我提供了一個很好的結束過渡。總而言之，我們認為這是一個穩健的季度。我們履行了承諾。我們超出了華爾街的實際預期。我們將繼續按照指南針行事，同時為患者創造真正的價值。我們所做的必將轉化為股東的價值。我們正在執行我們的計劃，我們將繼續致力於這樣做。

Thank you very much to all, and have a nice day.

非常感謝大家，祝大家有個愉快的一天。

Thank you, ladies and gentlemen. This does conclude today's teleconference, and we appreciate your participation. You may disconnect at any time, and have a wonderful day.

謝謝各位，女士們、先生們。今天的電話會議到此結束，我們感謝您的參與。您可以隨時斷開連接，祝您有美好的一天。