輝瑞 (PFE) 2023 Q3 法說會逐字稿

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

大家好，歡迎參加輝瑞 2023 年第三季財報電話會議。今天的通話正在錄音。現在，我想將電話轉給首席投資者關係長兼高級副總裁 Francesca DeMartino。請繼續，女士。

Good morning, and welcome to Pfizer's earnings call. I'm Francesco DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at pfizer.com. Earlier this morning, we released our results for the third quarter of 2023. Our earnings materials can be accessed on the IR website at investors.pfizer.com.

早安，歡迎參加輝瑞的財報電話會議。我是首席投資者關係官 Francesco DeMartino。我謹代表輝瑞團隊感謝您加入我們。此次電話會議透過 pfizer.com 上的音訊網路廣播進行。今天早些時候，我們發布了 2023 年第三季的業績。我們的獲利資料可在投資者關係網站 Investors.pfizer.com 上存取。

I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Dave Denton, our CFO; and Dr. Mikael Dolsten, President, Pfizer Research and Development. Joining for the Q&A session, we will also have Angela Hwang, Chief Commercial Officer and President, Global Pharmaceuticals business; Aamir Malik, our Chief Business Innovation Officer; Dr. Chris Boshoff, our Chief Oncology Research and Development Officer; and Doug Lankler, our General Counsel.

今天我們的董事長兼執行長 Albert Bourla 博士也加入了我的行列。戴夫‧丹頓 (Dave Denton)，我們的財務長；以及輝瑞研發部總裁 Mikael Dolsten 博士。參加問答環節的還有商務長兼全球製藥業務總裁 Angela Hwang； Aamir Malik，我們的首席業務創新長； Chris Boshoff 博士，我們的首席腫瘤學研究和開發官；以及我們的總法律顧問 Doug Lankler。

Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer on Slide 3. Additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and in our SEC Forms 10-K and 10-Q under Risk Factors and Forward-Looking Information and factors that may affect future results. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements.

在我們開始之前，我想提醒您，我們將做出前瞻性陳述。我鼓勵您閱讀幻燈片3 上的免責聲明。有關這些聲明和我們的非GAAP 財務指標的更多信息，請參閱我們的收益報告以及SEC 表格10-K 和10-Q 中的風險因素和前瞻性資訊以及可能影響未來結果的因素。電話會議中的前瞻性陳述存在重大風險和不確定性，僅在電話會議原始日期發表，我們不承擔更新或修改任何這些陳述的義務。

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

這樣，我會將電話轉給艾伯特。

Thank you, Francesca. Hello, everyone, and thank you for joining us today. Pfizer continues to have a far-reaching and positive impact on human health. Through the first 9 months of the year, more than 457 million patients around the world were treated with our medicines and vaccines. Compared with the first 9 months of 2022, we have reached more patients in several key therapeutic areas, including oncology, cardiovascular disease and anti-infectives. Patients will always be [on top], and these figures serve as a testament to our leadership in innovation and our commitment to understanding and serving patients' needs.

謝謝你，弗朗西斯卡。大家好，感謝您今天加入我們。輝瑞持續對人類健康產生深遠而正面的影響。今年前 9 個月，全球有超過 4.57 億名患者接受了我們的藥物和疫苗治療。與 2022 年前 9 個月相比，我們在幾個關鍵治療領域接觸了更多患者，包括腫瘤、心血管疾病和抗感染藥物。病人永遠是[最重要的]，這些數字證明了我們在創新方面的領導地位以及我們對理解和服務病人需求的承諾。

During the third quarter, we were encouraged by the continued strong performance of Pfizer's non-COVID products, with revenue from these products growing 10% operationally compared with the year ago quarter. We saw significant contribution from new launches and the robust year-over-year growth for several key in-line brands.

第三季度，我們對輝瑞非新冠產品持續強勁的表現感到鼓舞，這些產品的營運收入與去年同期相比成長了 10%。我們看到了新推出的重大貢獻以及幾個主要同線品牌的強勁同比增長。

Our recently launched respiratory syncytial virus, the RSV vaccine, which is called Abrysvo contributed $375 million in U.S. revenue. With the recent approval of the maternal indication, Pfizer is the only company an RSV vaccine approved for preventing RSV in older adults and in infant's maternal immunization.

我們最近推出的呼吸道合胞病毒 RSV 疫苗（稱為 Abrysvo）為美國貢獻了 3.75 億美元的收入。隨著最近批准的孕產婦適應症，輝瑞成為唯一批准用於老年人和嬰兒孕產婦免疫預防 RSV 疫苗的公司。

We believe Abrysvo will be a significant and growing contributor to revenues as many customers have indicated to us that protecting both populations with one vaccine is desirable and a competitive advantage for Abrysvo. In the U.S. alone, there are approximately 8 million adults over 86 who are eligible for RSV vaccination and an estimated 1.5 million pregnant women are eligible for maternal immunization with RSV vaccine between September 23 and January 24.

我們相信 Abrysvo 將成為收入的重要且不斷增長的貢獻者，因為許多客戶向我們表示，用一種疫苗保護兩種人群是可取的，這也是 Abrysvo 的競爭優勢。光是在美國，就有大約 800 萬 86 歲以上的成年人有資格接種 RSV 疫苗，估計有 150 萬孕婦有資格在 9 月 23 日至 1 月 24 日期間接種 RSV 疫苗。

Nurtec, Vydura and Oxbryta, which were acquired in the fourth quarter of 2022 contributed $233 million and $85 million in global revenues, respectively. For Nurtec in the U.S., oral CGRPs represent about 17% of the migraine market, and the unmet need is high. We believe oral CGRPs can ultimately be the first-line therapy for migraine and could eventually account for as much as 40% of the overall migraine market.

2022 年第四季收購的 Nurtec、Vydura 和 Oxbryta 分別貢獻了 2.33 億美元和 8,500 萬美元的全球收入。對於美國的 Nurtec 來說，口服 CGRP 約佔偏頭痛市場的 17%，且未滿足的需求很高。我們相信口服 CGRP 最終可以成為偏頭痛的第一線療法，並最終佔據整個偏頭痛市場的 40%。

Primary care is a clear source of potential growth in the migraine marketplace. Year-to-date, primary care healthcare providers wrote more than 6.1 million prescriptions for [flat dose] compared with approximately $1 million for all our CGRPs, which highlights a significant potential opportunity for growth.

初級保健是偏頭痛市場潛在成長的明顯來源。今年迄今為止，初級保健醫療保健提供者為[固定劑量]開了超過 610 萬張處方，而我們所有 CGRP 的處方約為 100 萬美元，這凸顯了巨大的潛在成長機會。

Regarding Oxbryta, there is significant burden of illness and unmet need for patients suffering from sickle cell disease. An estimated 12 million people around the world have SCD, sickle cell disease, with the highest prevalence in countries with the lowest resources. While in the U.S., 95% of children survive to adulthood, 99% of children in other regions will die before they reach their fifth birthday, many without even being ever diagnosed.

關於 Oxbryta，鐮狀細胞疾病患者面臨巨大的疾病負擔和未滿足的需求。據估計，全世界有 1,200 萬人患有 SCD（鐮狀細胞疾病），在資源最少的國家患病率最高。在美國，95% 的兒童能活到成年，而在其他地區，99% 的兒童會在五歲生日之前死亡，許多人甚至沒有被診斷出來。

Our Vyndaqel products, including Vyndaqel, Vyndamax Vynmac, recorded 47% operational growth globally compared to the third quarter of 2022. This growth was driven largely by continued strong uptake of transthyretin amyloid cardiomyopathy indication, primarily in the U.S. and developed Europe. We estimate that are between 120,000 and 150,000 people suffering from ATTR cardiomyopathy with the majority still not yet diagnosed.

與2022 年第三季相比，我們的Vyndaqel 產品（包括Vyndaqel、Vyndamax Vynmac）在全球範圍內實現了47% 的營運成長。這一增長主要是由於轉甲狀腺素蛋白澱粉樣心肌病變適應症的持續強勁採用（主要在美國和歐洲已開發國家）推動的。我們估計有 12 萬至 15 萬人患有 ATTR 心肌病變，其中大多數尚未確診。

The largest unmet need continues to be the lack of general understanding and ability to diagnose this deadly disease, which is why we are focused on educational activities to expand the diagnosis and get appropriate patients on the treatment with the programs as the proven standard of care.

最大的未滿足需求仍然是缺乏診斷這種致命疾病的普遍了解和能力，這就是為什麼我們專注於教育活動，以擴大診斷範圍，並讓適當的患者接受作為經過驗證的護理標準的計劃的治療。

Such efforts significantly contributed to this quarter's revenue increase in the U.S. And our Prevnar family of products, Prevnar 13 and Prevnar 20 saw global revenue rise 15% operationally compared with the year ago quarter. This increase was driven primarily by strong patient demand for Prevnar 20 adult in the U.S., the U.S. approval of Prevnar 20 pediatric and associated stocking and growth of Prevnar 13 pediatric in certain emerging markets.

這些努力極大地促進了本季美國收入的成長。與去年同期相比，我們的 Prevnar 系列產品 Prevnar 13 和 Prevnar 20 的全球營運收入成長了 15%。這一增長主要是由於美國患者對 Prevnar 20 成人的強勁需求、美國批准 Prevnar 20 兒科及相關庫存以及 Prevnar 13 兒科在某些新興市場的成長。

These were partially offset by anticipated lower market share in the U.S. for Prevnar pediatric due to competitive entry. Of note, Prevnar 20 adult remains the category-leading pneumococcal vaccine for adults in the U.S. with a 95% market share in the third quarter. Year-to-date, revenues for our non-COVID products have grown 7% operationally, and we remain on track to deliver 6% to 8% operational revenue growth for these products for the full year.

由於競爭進入，Prevnar 兒科在美國的市佔率預期下降，部分抵消了這些影響。值得注意的是，Prevnar 20 成人仍然是美國成人肺炎鏈球菌疫苗的領先類別，第三季佔 95% 的市場。今年迄今，我們的非新冠肺炎產品的營運收入成長了 7%，我們仍有望實現這些產品全年營運收入成長 6% 至 8%。

We continue to progress towards our goal of executing an unprecedented number of launches of new products or indications. Recent milestones include: U.S. and EU approvals and the launch of Abrysvo in pregnant individuals; U.S. approval and launch of Elrexfio in relapsed refractory multiple myeloma; U.S. approval of our Braftovi and Mektovi combination in BRAF-mutated metastatic non-small cell lung cancer; U.S. approval of Velsipity for moderate to severe ulcerative colitis; EC approval of Litfulo for severe alopecia areata; and U.S. approval of Penbraya, the first and only pentavalent vaccine that provides coverage against the 5 most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

我們將繼續朝著推出數量空前的新產品或適應症的目標邁進。最近的里程碑包括： 美國和歐盟的批准以及 Abrysvo 在孕婦中的上市； Elrexfio 在美國核准並上市，用於治療復發難治性多發性骨髓瘤；美國批准我們的 Braftovi 和 Mektovi 組合治療 BRAF 突變的轉移性非小細胞肺癌；美國批准 Velsipity 治療中重度潰瘍性結腸炎； EC 核准 Litfulo 治療嚴重斑禿；美國批准了 Penbraya，這是第一個也是唯一一個五價疫苗，可針對導致 10 至 25 歲青少年和年輕人腦膜炎球菌疾病的 5 種最常見血清群。

Today, we have now executed 13 of the 19 originally identified potential launches with 4 other products approved and preparations being made for their launch. In fact, 5 of the 6 remaining potential launches have been largely derisked from a technical perspective. The only one remaining would be our mRNA flu candidate.

今天，我們已經執行了最初確定的 19 種潛在發布產品中的 13 種，另外 4 種產品已獲得批准，並正在為它們的發布做準備。事實上，從技術角度來看，剩下的 6 項潛在發射中的 5 項基本上已經消除了風險。剩下的唯一一個就是我們的 mRNA 流感候選藥物。

Given our recent positive results from our next-generation mRNA flu/COVID combination candidate and pending results for our 65 and older first generation, first 3 stand-alone mRNA flu study, timing of our stand-alone mRNA flu is now expected after 2024. If successful, our next-generation mRNA flu/COVID combination candidate is expected to market in 2025. Mikael will share more about these programs shortly.

鑑於我們的下一代mRNA 流感/新冠肺炎聯合候選藥物最近的積極成果，以及我們65 歲及以上第一代、前3 項獨立mRNA 流感研究的待定結果，我們的獨立mRNA 流感研究的時間現在預計在2024 年之後。如果成功，我們的下一代 mRNA 流感/新冠肺炎組合候選藥物預計將於 2025 年上市。Mikael 將很快分享有關這些項目的更多資訊。

We remain excited about our proposed acquisition of Seagen and the dramatic impact we think this combination can have on human health. One in three people will be diagnosed with cancer in their lifetime. So conquering cancer would have an almost unimaginable impact on humanity. We recently gained unconditional antitrust clearance from the EC and we continue to expect the transaction to close in late 2023 or early 2024, subject to customary closing conditions, including clearance by the U.S. FTC.

我們對收購 Seagen 的提議以及我們認為這一組合對人類健康的巨大影響仍然感到興奮。三分之一的人一生中會被診斷出罹患癌症。因此，戰勝癌症將對人類產生幾乎難以想像的影響。我們最近獲得了歐盟委員會的無條件反壟斷許可，我們繼續預期該交易將在 2023 年末或 2024 年初完成，但須符合慣例成交條件，包括美國聯邦貿易委員會的許可。

We have raised $31 billion in acquisition financing so far and continue to expect incremental 2030 risk-adjusted revenues in excess of $10 billion and expected cost efficiencies of $1 billion to be realized by the end of year 3 post close without impacting any R&D programs.

到目前為止，我們已籌集了310 億美元的收購融資，並繼續預計2030 年經風險調整後的收入增量將超過100 億美元，並預計在交易結束後的第3 年年底實現10 億美元的成本效率，而不會影響任何研發項目。

With that, I'll turn it over to Dave. And after Dave, Mikael will provide an update on our R&D pipeline. So Dave?

有了這個，我會把它交給戴夫。在 Dave 之後，Mikael 將提供我們研發管道的最新資訊。那麼戴夫？

Thank you, Albert, and good morning. Before I review this quarter's results, I'll address a couple of topics that have been top of mind with investors since our announcement on October 13. These topics relate to our future U.S. government Paxlovid revenue forecast as well as our multiyear cost realignment program.

謝謝你，艾伯特，早安。在回顧本季業績之前，我將討論自 10 月 13 日宣布以來投資者最關心的幾個主題。這些主題與我們未來的美國政府 Paxlovid 收入預測以及我們的多年成本調整計劃有關。

With respect to revenue recognition associated with the amended agreement, the U.S. government is expected to return an estimated 7.9 million EUA-labeled treatment courses, and in return, we'll receive a volume-based credit at an approximate value of $4.2 billion at the end of 2023 for future treatment courses. Pfizer will also provide an additional 1 million treatment courses into the U.S. strategic national stockpile.

關於與修訂後的協議相關的收入確認，美國政府預計將返還約 790 萬個帶有 EUA 標籤的治療課程，作為回報，我們將獲得價值約 42 億美元的基於數量的信貸2023 年底未來的治療課程。輝瑞也將向美國國家戰略儲備額外提供 100 萬個療程。

As a result of all of that, Pfizer has an obligation to deliver an estimated 8.9 million treatment courses, for which we will record an approximately $4.2 billion of revenue beginning in 2024 as we deliver these treatment courses. It is important to note that there is no cash compensation for the estimated 8.9 million treatment courses delivered.

因此，輝瑞有義務提供約 890 萬個治療課程，從 2024 年開始，我們將在提供這些治療課程時錄得約 42 億美元的收入。值得注意的是，預計提供的 890 萬個療程沒有現金補償。

Regarding our cost realignment program, I want to reiterate that we expect to achieve at least $3.5 billion in net cost savings by the end of 2024 versus the midpoint of our August 1, 2023 SI&A and R&D guidance. We expect $1 billion of targeted savings in 2023 and expect an additional savings of at least $2.5 billion in 2024. In a moment, when I review the components of our full year 2023 guidance, you will see that we have lowered the midpoints of both our SI&A and R&D guidance ranges by $500 million, respectively.

關於我們的成本調整計劃，我想重申，與 2023 年 8 月 1 日 SI&A 和研發指南的中位數相比，我們預計到 2024 年底將實現至少 35 億美元的淨成本節省。我們預計 2023 年目標節省 10 億美元，並預計 2024 年至少額外節省 25 億美元。稍後，當我回顧 2023 年全年指導的各個組成部分時，您會發現我們降低了兩個目標的中點SI&A 和研發指引範圍分別為5 億美元。

Now turning to the quarter. Our Q3 results, both top and bottom line were significantly and negatively impacted by our COVID products. Revenues declined 41% operationally, the result of the decrease in both Paxlovid and Comirnaty sales, while adjusted diluted loss per share was also significantly impacted by $5.6 billion of noncash inventory write-offs of COVID-related inventories.

現在轉向季度。我們第三季的業績，無論是頂線還是底線，都受到了我們的新冠產品的重大負面影響。營運收入下降了 41%，這是 Paxlovid 和 Comirnaty 銷售額下降的結果，而調整後的攤薄每股虧損也受到了與新冠病毒相關的庫存的 56 億美元非現金庫存沖銷的嚴重影響。

I want to emphasize as Albert stated previously that the operational revenue growth of our products in Q3, excluding both Paxlovid and Comirnaty were strong at 10%. Contributing to the strong performance was our newly approved RSV vaccine and the families of products associated with both Prevnar and Vyndaqel.

我想強調的是，正如 Albert 之前所說，我們的產品在第三季（不包括 Paxlovid 和 Comirnaty）的營運收入成長強勁，達到 10%。我們新批准的 RSV 疫苗以及與 Prevnar 和 Vyndaqel 相關的產品系列為我們的強勁業績做出了貢獻。

Additionally, our recently acquired products, Nurtec and Oxbryta also contributed to this strong performance. Our reported diluted loss per share of $0.42 and adjusted diluted loss per share of $0.17 in the quarter are primarily the result of the decline in Paxlovid and Comirnaty sales and the noncash charge related to write-offs of COVID-related inventories.

此外，我們最近收購的產品 Nurtec 和 Oxbryta 也為這一強勁表現做出了貢獻。我們報告的本季攤薄每股虧損為 0.42 美元，調整後每股攤薄虧損為 0.17 美元，主要是由於 Paxlovid 和 Comirnaty 銷售額下降以及與新冠病毒相關庫存沖銷相關的非現金費用。

The inventory write-off of $4.7 billion for Paxlovid and $900 million for Comirnaty negatively affected adjusted loss per share by $0.84. Foreign exchange movements had a de minimis unfavorable impact on third quarter revenues and increased adjusted diluted loss per share by $0.04 or 2% compared to LY.

Paxlovid 47 億美元和 Comirnaty 9 億美元的庫存沖銷對調整後每股虧損產生了 0.84 美元的負面影響。外匯波動對第三季營收產生了微乎其微的不利影響，調整後每股攤薄虧損比 LY 增加了 0.04 美元或 2%。

Now let me briefly touch on our full year guidance. Given we updated our full year revenue and EPS guidance on October 13, I'm just going to hit a few of the highlights. Total company full year 2023 revenues are expected to be in the range of $58 million to $61 billion versus the previous range of $67 billion to $70 billion.

現在讓我簡要談談我們的全年指導。鑑於我們於 10 月 13 日更新了全年收入和每股收益指引，我只想談談一些要點。該公司 2023 年全年總收入預計將在 5,800 萬美元至 610 億美元之間，而之前的範圍為 670 億美元至 700 億美元。

Importantly, we continue to expect 6% to 8% full year operational revenue growth for non-COVID products year-over-year. And as anticipated, the majority of this growth is incurred in the second half of the year given the timing of new products and indicated launches.

重要的是，我們繼續預計非新冠疫情產品的全年營運收入將年增 6% 至 8%。正如預期的那樣，考慮到新產品和指定發布的時間，這一增長的大部分發生在下半年。

I want to remind you that beginning in Q4, we will overlap the acquisitions of both Biohaven and GBT and which will -- which were completed in October of 2022. Adjusted cost of sales and percentage of revenue is expected to be in the range of 41% to 43%, primarily the result of a $5.6 billion noncash charge related to inventory write-offs for our COVID products.

我想提醒您，從第四季度開始，我們將重疊收購 Biohaven 和 GBT，這些收購將於 2022 年 10 月完成。調整後的銷售成本和收入百分比預計將在 41 範圍內% 至43%，主要是與我們的新冠病毒產品庫存沖銷相關的56 億美元非現金費用的結果。

Adjusted SI&A expenses are expected to be in the range of $13.3 billion to $14.3 billion and adjusted R&D expenses to be within a range of $11.9 billion to $12.9 billion. The midpoints of both ranges are now $500 million lower than our original guidance. As a result of all these, the company now expects full year adjusted diluted earnings per share to be in the range of $1.45 to $1.65 per share versus the original guidance range of $3.25 to $3.45.

調整後的 SI&A 費用預計在 133 億美元至 143 億美元之間，調整後的研發費用預計在 119 億美元至 129 億美元之間。這兩個範圍的中點現在比我們最初的指引低了 5 億美元。由於所有這些因素，該公司目前預計全年調整後稀釋每股收益將在每股 1.45 美元至 1.65 美元之間，而最初的指導範圍為 3.25 美元至 3.45 美元。

All additional components of our guidance are included in our press release that was issued earlier today. As discussed in prior quarters, our capital allocation strategy is based on 3 core pillars: first is reinvesting in our business; second is growing our dividends over time; and third is making value-enhancing share repurchases.

我們指南的所有其他內容均包含在今天早些時候發布的新聞稿中。正如前幾季所討論的，我們的資本配置策略是基於三個核心支柱：首先是對我們業務的再投資；其次是隨著時間的推移增加我們的股息；第三是進行增值股票回購。

In the first 9 months of 2023, we invested $7.9 billion in internal R&D, returned $6.9 billion to shareholders via our quarterly dividend and allocated approximately $43 billion towards the proposed Seagen acquisition. Lastly, in addition to completing a $31 billion unsecured debt offering in Q2 of this year, we are ready to execute the remaining short-term financing to complete the proposed Seagen acquisition upon fulfillment of the required closing conditions. We expect to delever our capital structure following the completion of this transaction. And as we delever, we anticipate returning to a more balanced capital allocation strategy, inclusive of share repurchases.

2023 年前 9 個月，我們在內部研發方面投資了 79 億美元，透過季度股息向股東返還 69 億美元，並為擬議的 Seagen 收購分配了約 430 億美元。最後，除了在今年第二季完成 310 億美元的無擔保債務發行外，我們還準備執行剩餘的短期融資，以在滿足所需的成交條件後完成擬議的 Seagen 收購。我們預期本次交易完成後將去槓桿化我們的資本結構。隨著我們去槓桿化，我們預計將回歸更平衡的資本配置策略，包括股票回購。

In closing, I want to reiterate that our product portfolio remains very strong. We continue to be encouraged by the momentum of our non-COVID products in Q3 and are committed to the successful execution of our new product and indication launches. We expect the cost realignment program will improve our operating margin, enhancing long-term shareholder value.

最後，我想重申我們的產品組合仍然非常強大。我們繼續對第三季非新冠產品的勢頭感到鼓舞，並致力於成功執行我們的新產品和適應症的發布。我們預期成本調整計畫將提高我們的營業利潤率，提高長期股東價值。

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

接下來，讓我把它交給 Mikael。

Thank you, Dave. Today, I will share important updates from our robust respiratory vaccine portfolios. Our respiratory vaccines are built up on 3 cutting-edge platforms that enable us to bring the right science to the right pathogen. These include our mRNA platform in partnership with BioNTech targeting highly virulent viruses, our subunit platform targeting viruses that remain relatively consistent season to season and our conjugate vaccine platform designed to help prevent bacterial infections.

謝謝你，戴夫。今天，我將分享我們強大的呼吸道疫苗產品組合的重要更新。我們的呼吸道疫苗建立在 3 個尖端平台之上，使我們能夠將正確的科學應用於正確的病原體。其中包括我們與 BioNTech 合作針對高毒力病毒的 mRNA 平台、針對季節性保持相對一致的病毒的亞單位平台以及旨在幫助預防細菌感染的結合疫苗平台。

We have achieved FDA approvals of vaccines derived from each platform within the last year and aim to further expand our leadership with additional vaccine candidates in development. Today, I will provide information on our stand-alone flu vaccine candidate, flu/COVID combination vaccine candidate and next-gen pneumococcal vaccine candidate.

去年，我們已獲得 FDA 對每個平台的疫苗的批准，並旨在透過開發更多候選疫苗進一步擴大我們的領導地位。今天，我將提供有關我們的獨立流感疫苗候選疫苗、流感/新冠肺炎聯合疫苗候選疫苗和下一代肺炎球菌候選疫苗的資訊。

We are pleased to announce that we achieved both primary endpoints in the 18- to 64-year-old cohort of our ongoing Phase III flu trial. In the trial, our first-gen mRNA flu vaccine candidate demonstrated noninferiority and superiority to a licensed flu vaccine at the time of the primary analysis. This represents the first and only demonstration of efficacy and superiority for an mRNA-based flu vaccine candidate.

我們很高興地宣布，我們正在進行的 III 期流感試驗的 18 至 64 歲隊列中實現了兩個主要終點。在試驗中，我們的第一代 mRNA 候選流感疫苗在初步分析時表現出與許可的流感疫苗的非劣效性和優越性。這是首次也是唯一一次證明基於 mRNA 的候選流感疫苗的功效和優越性。

In this age cohort, efficacy was maintained through the trial's end-of-season analysis, with our candidate remaining noninferior to the licensed comparator. Safety was similar to the standard flu vaccine. The primary and end-of-season efficacy analysis considered both in terms of A and B cases collectively.

在這個年齡層中，透過試驗的季末分析保持了療效，我們的候選藥物仍然不劣於許可的比較藥物。安全性與標準流感疫苗相似。主要和季末功效分析綜合考慮了 A 和 B 兩種情況。

The vast majority of cases recorded in our trial and during the '22/'23 flu season overall were flu A cases. The immunogenicity data showed robust antibody responses against influenza A compared to licensed flu vaccine. Humoral responses against Influenza B were lower than those achieved with the comparator. Recall that our stand-alone flu vaccine Phase III study also include a 65-year and older cohort that we previously shared encouraging T cell data for all 4 strains from the Phase II study in this cohort.

我們的試驗中以及「22/23」流感季節期間記錄的絕大多數病例都是甲型流感病例。免疫原性數據顯示，與許可的流感疫苗相比，針對甲型流感的抗體反應更強。針對乙型流感的體液反應低於對照組。回想一下，我們的獨立流感疫苗 III 期研究還包括一個 65 歲及以上的隊列，我們之前分享了該隊列 II 期研究中所有 4 種病毒株的令人鼓舞的 T 細胞數據。

Our belief is that the ability of the vaccine candidates induce T cell responses may contribute to the improved efficacy of our current seasonal flu vaccines, particularly in those 65 and older. We expect a readout from this age group later this year. To address the lower B responses seen with our first-gen stand-alone flu candidate, Pfizer created next-generation reformulation. These were incorporated into our mRNA flu candidate in combination with the Pfizer BioNTech COVID-19 vaccine, which I will review now.

我們相信，候選疫苗誘導 T 細胞反應的能力可能有助於提高我們目前季節性流感疫苗的功效，特別是對於 65 歲及以上的老年人。我們預計今年稍後會公佈該年齡層的數據。為了解決第一代獨立流感候選藥物 B 反應較低的問題，輝瑞制定了下一代重新配方。這些已與輝瑞 BioNTech COVID-19 疫苗結合納入我們的 mRNA 流感候選疫苗中，我現在將對此進行審查。

In positive Phase I, II top line data announced last week, we observed that reformulation of the lead flu candidate resulted in improved BioNTech against Influenza B, allowing us to meet all criteria for advancement to Phase III. In the trial, our lead candidate formulations induced robust immune responses with point estimates for geometric mean titer ratios that were consistently criteria applied to approved vaccines for all matched flu and SARS-CoV2 strains.

在上周公布的第一階段、第二階段的積極數據中，我們觀察到，主要流感候選藥物的重新配方導致針對乙型流感的 BioNTech 得到改進，使我們能夠滿足進入第三階段的所有標準。在試驗中，我們的主要候選製劑透過幾何平均滴度比的點估計誘導了強大的免疫反應，這是適用於所有匹配的流感和 SARS-CoV2 株的批准疫苗的一致標準。

Notably, a point estimate for geometric mean titer ratios with selected candidate formulations were greater than one relative to their licensed comparator for all matched flu vaccine strains. The safety profile of evaluated candidates were consistent with Pfizer's own COVID-19 vaccine. Following these positive immunogenicity data, we plan to initiate the Phase III study in the coming months.

值得注意的是，相對於所有匹配的流感疫苗株的許可比較劑，所選候選製劑的幾何平均滴度比的點估計值大於 1。接受評估的候選疫苗的安全性與輝瑞自己的 COVID-19 疫苗一致。根據這些積極的免疫原性數據，我們計劃在未來幾個月內啟動 III 期研究。

Successfully developing a broad seasonal vaccine franchise anchored around the modFlu mRNA vaccine is a key priority as it may allow us to tap into the nearly 50% annual flu vaccination rate in the U.S. adults.

成功開發以 modFlu mRNA 疫苗為基礎的廣泛季節性疫苗系列是一個關鍵優先事項，因為它可能使我們能夠利用美國成年人近 50% 的年度流感疫苗接種率。

We are taking a differentiated approach in pursuit of this goal, leveraging both mRNA and protein subunit technologies. Our development program includes double and triple combination vaccines to potentially help protect against flu, COVID-19 and RSV.

我們正在採取差異化的方法來實現這一目標，利用 ​​mRNA 和蛋白質亞基技術。我們的開發計劃包括雙重和三重組合疫苗，可能有助於預防流感、COVID-19 和 RSV。

Now turning to Prevnar. I'll start by reminding you that this is the only PCV business with an FDA indication for pneumonia in adults. Providing protection specifically against pneumococcal pneumonia is critical. It's the most common form of pneumococcal disease in adults, leading to 150,000 U.S. hospitalizations each year. The prevalence of nonbacteremic pneumococcal pneumonia is more than 15-fold, greater than that of invasive pneumococcal disease in U.S. adults 50 and older.

現在轉向 Prevnar。首先我要提醒您，這是唯一一家獲得 FDA 批准用於治療成人肺炎的 PCV 企業。提供專門針對肺炎球菌肺炎的保護至關重要。這是成人中最常見的肺炎球菌疾病，每年導緻美國 15 萬人住院。在 50 歲及以上的美國成年人中，非菌血症性肺炎鏈球菌肺炎的盛行率是侵襲性肺炎球菌疾病的 15 倍以上。

Prevnar's pneumonia indication is supported by the CAPiTA trial which was enabled by a pneumococcal vaccine population and proprietary assay. These innovative characteristics make it challenging for others to conduct a similar study given the high level of pneumococcal vaccine coverage that exists today.

Prevnar 的肺炎適應症得到了 CAPiTA 試驗的支持，該試驗是透過肺炎球菌疫苗群和專有測定法實現的。鑑於目前肺炎鏈球菌疫苗的覆蓋率很高，這些創新特徵使得其他人很難進行類似的研究。

CAPiTA's innovative design and landmark results helped to establish our leading and differentiated position in the PCV space. To solidify this position, we are committed to pursuing continued innovation. Our goal is to potentially maximize valency and improving immunogenicity while maintaining coverage of the serotypes clinically demonstrated to protect against pneumonia.

CAPiTA 的創新設計和里程碑式的成果幫助我們確立了在 PCV 領域的領先和差異化地位。為了鞏固這一地位，我們致力於不斷創新。我們的目標是潛​​在地最大化效價並提高免疫原性，同時保持臨床證明可預防肺炎的血清型的覆蓋範圍。

In line with this commitment, we have been developing in a fourth generation PCV candidate that builds on the Prevnar business' 20-year-plus years of innovation. Our next-generation technology leverages cutting-edge conjugation, chemistry, carriers and reformulations. Using these new proprietary vaccine technologies, we observed a several-fold improvement in select serotype immunogenicity in a monovalent Phase I study.

根據這項承諾，我們一直在開發第四代 PCV 候選產品，該候選產品建立在 Prevnar 業務 20 多年的創新基礎上。我們的下一代技術利用尖端的綴合、化學、載體和重新配方。使用這些新的專有疫苗技術，我們在單價 I 期研究中觀察到選定血清型免疫原性增加了數倍。

Based on these data, we are confident that when we move these technologies into our multivalent fourth-gen candidate, we have the potential to achieve increased valency with improved serotyping immunogenicity. We are now advancing our fourth generation candidate into our first human trial, which is expected to begin in the fourth quarter of '23.

基於這些數據，我們相信，當我們將這些技術轉移到我們的多價第四代候選藥物時，我們有可能透過改善血清分型免疫原性來實現更高的效價。我們現在正在將我們的第四代候選藥物推進到我們的第一次人體試驗中，預計將於 23 年第四季開始。

Finally, I will leave you with our list of milestones and call out the recent approval of Velsipity for ulcerative colitis and Penbraya, the first pentavalent meningococcal vaccine. Pfizer has delivered more than a dozen regulatory approvals this year alone. I'll also note the recent launches of Abrysvo for maternal immunization and Elrexfio in multiple myeloma.

最後，我將向您介紹我們的里程碑清單，並提及最近批准用於治療潰瘍性結腸炎的 Velsipity 和第一個五價腦膜炎球菌疫苗 Penbraya。光是今年，輝瑞就獲得了十多項監管批准。我還要指出最近推出的用於孕產婦免疫的 Abrysvo 和用於治療多發性骨髓瘤的 Elrexfio。

Thank you. Let me turn it back to Francesca to start the Q&A session.

謝謝。讓我把它轉回弗朗西斯卡來開始問答環節。

Thanks, Mikael. With that, let's start the Q&A session. We will answer as many questions as time permits and IR will be available after the call to answer any follow-up questions. Operator, please assemble the queue.

謝謝，米凱爾。那麼，讓我們開始問答環節。我們將在時間允許的情況下回答盡可能多的問題，IR 將在通話後回答任何後續問題。接線員，請整理隊列。

(Operator Instructions) And our first question will come from Robyn Karnauskas with Truist Securities.

（操作員說明）我們的第一個問題將來自 Truist Securities 的 Robyn Karnauskas。

I think I have a big picture question on your new launches, which is extremely important for your growth. Are you seeing any impact given, I think, vaccine fatigue that we've seen with COVID impacting RSV and pneumococcal vaccines? And how do you think about that impact as you think about 2023 and 2024? Do you think that will dissipate?

我想我對你們的新產品有一個大局問題，這對你們的成長極為重要。我認為，您是否看到了我們所看到的疫苗疲勞對 RSV 和肺炎球菌疫苗的影響？當您展望 2023 年和 2024 年時，您如何看待這種影響？你認為這會消散嗎？

Thank you for your questions. First of all, I think it's good when you have a portfolio, and we have a quite strong portfolio because we have [Oxbryta], we have [Comirnaty], we have pneumococcal in the respiratory front.

謝謝您的提問。首先，我認為擁有一個投資組合是件好事，我們有一個相當強大的投資組合，因為我們有 [Oxbryta]，我們有 [Comirnaty]，我們有呼吸道前線的肺炎球菌。

But I think the biggest impact will be when and if we have combination products. We think that combination products will -- because of their convenience, because of vaccines are preferred by virus with (inaudible) will increase basically the volumes and vaccination rates of all vaccines because of the convenience of one injection. And I think this is why you saw from Mikael, all our efforts right now are in development in multiple combinations, so that consumers and physicians will have choice, which ones to administer always with the same convenience.

但我認為最大的影響將是我們何時以及是否有組合產品。我們認為，組合產品將－因為它們的便利性，因為疫苗是病毒所偏好的（聽不清楚），因為一次注射的便利性，基本上將增加所有疫苗的數量和疫苗接種率。我想這就是為什麼你從 Mikael 那裡看到的，我們現在所有的努力都在以多種組合的形式進行開發，這樣消費者和醫生就可以選擇，總是以同樣的便利性來管理哪些藥物。

I think we can go to the next question. Thank you very much, Robyn.

我想我們可以討論下一個問題。非常感謝你，羅賓。

Our next question will come from Huynh Trung with UBS.

我們的下一個問題將來自瑞銀集團的 Huynh Trung。

I have one on flu and then just one on danu. So on flu, can you confirm the comparator in the 18 to 64 and also the 64 age groups was the low dose flu vaccines? Is there a risk FDA is going to need data against high-dose flu vaccines? And from a commercial perspective, do you think you still need high dose flu data, the comparator against high-dose flu data, given that's what's recommended by CDC in the older population?

我服用了一份流感疫苗，然後只服用了一份達努疫苗。那麼關於流感，您能否確認18歲至64歲以及64歲年齡層的對照組是低劑量流感疫苗？ FDA 是否存在需要針對高劑量流感疫苗的數據的風險？從商業角度來看，您認為您仍然需要高劑量流感數據，即與高劑量流感數據的比較器，因為這是 CDC 對老年族群的建議？

And then on danu, should we just -- just on the data that we expect before year-end, what do you need to show in that in order to move it into Phase III trials? Is something similar to the Phase II we saw earlier this year enough to move it to Phase III?

然後，關於 danu，我們是否應該僅根據我們在年底前預期的數據，您需要在其中展示什麼才能將其進入 III 期試驗？與我們今年早些時候看到的第二階段類似的東西是否足以將其轉移到第三階段？

Thank you. On the flu comparator, I can confirm that it is the low dose on the younger population because that's the only one that's allowed. So on the older operation, we are having studies now with the low dose, but we will do also with the higher dose. So we have both.

謝謝。在流感比較器上，我可以確認這是針對年輕人的低劑量，因為這是唯一允許的劑量。因此，對於較舊的手術，我們現在正在使用低劑量進行研究，但我們也會使用較高劑量進行研究。所以我們兩者都有。

On danu, there's not much to say. We need to wait to see the data. There is clearly, when you are moving ahead with a program like that, you need to see the totality of the data. And we are working now or eventually to be able to have this data presented before year-end.

關於達努，沒什麼好說的。我們需要等待才能看到數據。顯然，當您繼續執行這樣的程序時，您需要查看資料的整體性。我們現在正在努力或最終能夠在年底前提供這些數據。

Let's move to the next question.

讓我們進入下一個問題。

Our next question will come from Umer Raffat with Evercore.

我們的下一個問題將來自 Evercore 的 Umer Raffat。

I wanted to continue on the oral obesity theme for a second. I noticed there is a new molecule 522 that you moved into Phase I. And my question is, is the chemical structure and the chemical series akin to the danu and lotiglipron programs? And also, Albert, you mentioned you want to wait to see the danuglipron Phase II data, but I realized the trial has been wrapped up for a few weeks. Now have you not seen it yet?

我想繼續討論口腔肥胖的主題。我注意到有一個新的分子 522 已進入第一階段。我的問題是，化學結構和化學系列是否類似於 Danu 和 Lotiglipron 程序？另外，Albert，你提到你想等待看到 danuglipron II 期數據，但我意識到試驗已經結束了幾週。現在你還沒看到嗎？

Yes. Mikael, would you like to take the question about the new molecule and the danu?

是的。 Mikael，您想回答有關新分子和 Danu 的問題嗎？

Yes. We are building a platform around the glip area and also obesity in general with multiple different mechanisms and compounds. We remain focused on the danuglipron readout, as Albert mentioned, as our main opportunity here for getting data to review for obesity in type 2 diabetes. But there are many indications where glip might play a role outside of typical metabolic. So this one gives us just more option to explore and have interesting data. And you will see more new mechanisms also coming from Pfizer. We have a pretty strong effort here. Thank you.

是的。我們正在圍繞 glip 區域以及一般肥胖症建立一個具有多種不同機制和化合物的平台。正如 Albert 所提到的，我們仍然關注 danuglipron 讀數，這是我們獲取數據以審查 2 型糖尿病肥胖的主要機會。但有許多跡象表明，glip 可能在典型的代謝之外發揮作用。因此，這為我們提供了更多探索和獲取有趣數據的選擇。您還會看到更多來自輝瑞的新機制。我們在這裡付出了相當大的努力。謝謝。

Next, we have Terence Flynn with Morgan Stanley.

接下來請來摩根士丹利的特倫斯弗林。

Maybe 2 for me. I was just wondering on your RSV launch, how we should think about potential for revaccination in 2024. And then on your DMD gene therapy program, I think you previously talked about having interim data by year-end. Is that still the case? And does the recent competitor data make you more or less optimistic in your program?

也許對我來說是2個。我只是想知道你們的 RSV 發布，我們應該如何考慮 2024 年重新接種疫苗的可能性。然後關於你們的 DMD 基因治療計劃，我想你們之前談到過在年底之前獲得中期數據。現在還是這樣嗎？最近的競爭對手數據是否讓您對您的計劃更加樂觀或更不樂觀？

Thank you very much. First of all, let me make a comment on the recent data that we saw about the DMD. It's very, very bad news for patients. We are really -- at least the patient progression that doesn't have solutions, I hope there will be a solution for them with the discussion of the FDA but I can't comment.

非常感謝。首先，讓我對我們最近看到的 DMD 的數據發表評論。這對患者來說是非常非常壞的消息。我們確實——至少是沒有解決方案的患者進展，我希望透過 FDA 的討論可以為他們找到解決方案，但我無法發表評論。

Now on our DMD program, I will ask Mikael to comment on that. And then on the RSV, Angela. Mikael, why don't you start with the DMD and then, Angela, go to RSV.

現在，關於我們的 DMD 計劃，我將請 Mikael 對此發表評論。然後是 RSV，安吉拉。 Mikael，為什麼不從 DMD 開始，然後，Angela，轉到 RSV。

Yes, this comment that we also always said when -- somewhat favorable study. We are very encouraged about getting to the readout. You are right, there is an opportunity for an interim analysis around year-end with final analysis second half of next year. And overall, I think our gene therapy for DMD have shown a very consistent effect across biomarkers and functional endpoints.

是的，我們也總是說這個評論——有些有利的研究。我們對讀出結果感到非常鼓舞。你是對的，年底左右有機會進行中期分析，明年下半年進行最終分析。總的來說，我認為我們針對 DMD 的基因療法在生物標記和功能終點方面顯示出非常一致的效果。

And what has been differentiated it so far is that when you look at the functional data we have reported, it has been given encouraging signals in both the younger and the slightly older boys, and that has not been seen with the other company you referred to. So in a way, I remain as earlier, very positive about looking forward to the readout and let the data tell you the story. But of course, this makes our gene therapy, in a way, the main game in town.

到目前為止，差異化的是，當你查看我們報告的功能數據時，在年輕和稍大的男孩中都給出了令人鼓舞的信號，而你提到的其他公司還沒有看到這種情況。因此，在某種程度上，我仍然像之前一樣，非常積極地期待結果，讓數據告訴你故事。但當然，這使得我們的基因療法在某種程度上成為城裡的主要遊戲。

Then there was a question, Angela, on the RSV.

安吉拉，然後有一個關於 RSV 的問題。

Well, as you heard during the ACIP discussions, our recommendation for Abrysvo today is really one around clinical -- shared clinical decision-making. But we also were -- we were asked to bring additional data when they are ready. And so just to confirm that we will have additional data in vaccine effectiveness in broader populations. We will have safety data also in broader populations. We will also have immunogenicity data in younger populations.

嗯，正如您在 ACIP 討論中聽到的那樣，我們今天對 Abrysvo 的建議實際上是圍繞臨床的——共享臨床決策。但我們也被要求在準備好後提供更多數據。這只是為了確認我們將獲得更多關於疫苗在更廣泛人群中有效性的數據。我們還將獲得更廣泛人群的安全數據。我們還將獲得年輕族群的免疫原性數據。

All of this will be, I think, available in the next year when we plan to bring this back to the CDC. In addition to that, actually I needed to mention that we'll also have second season efficacy data. So we'll able to bring this totality of data together to determine whether the recommendations will change, but also what the vaccination schedule will be. So that's to come in 2024.

我認為，所有這些都將在明年我們計劃將其帶回疾病預防控制中心時提供。除此之外，實際上我需要提到的是，我們還將有第二季的功效數據。因此，我們將能夠將所有數據匯總在一起，以確定建議是否會改變，以及疫苗接種時間表。這將在 2024 年實現。

Next, we have Steve Scala with TD Cowen.

接下來是 Steve Scala 和 TD Cowen。

As was just noted a couple of minutes ago, the danu data has reached its primary completion. It was a while ago. Albert, when you were asked, you stressed the words, totality of the data, implying that you could have seen some part of the data. Mikael, when you were asked, you talked about different indications.

正如幾分鐘前所指出的，danu 資料已基本完成。那是不久前的事了。艾伯特，當你被問到時，你強調了數據的整體性，這意味著你可能已經看到了數據的某些部分。米凱爾，當你被問到時，你談到了不同的跡象。

These are not confidence-building statements. So I'm curious what have you seen. And Mikael, you've said in the past, you are absolutely encouraged and confident in the profile of danu. Are you still absolutely encouraged and confident? So that's the first question.

這些不是建立信任的聲明。所以我很好奇你看到了什麼。米凱爾，你過去說過，你對達努的形象絕對感到鼓舞和信心。您仍然充滿信心和信心嗎？這是第一個問題。

Secondly, a competitor spoke to potentially COVID-derived decrease in diagnosis of inflammatory diseases such as UC. And I'm wondering if you've seen any of that.

其次，一位競爭對手談到了新冠病毒可能導致 UC 等發炎性疾病診斷率下降。我想知道你是否見過這些。

Steve, I think you likely misunderstood my comments on the totality. It has nothing to do with any data that I have seen because I haven't, right? So the data have not been presented to -- I don't think that the study has been completed yet. So I will ask also Mikael to comment on that. But don't read, please, anything on the totality of the data.

史蒂夫，我認為你可能誤解了我對整體的評論。它與我見過的任何數據無關，因為我沒有見過，對嗎？所以數據還沒有提交給——我認為這項研究還沒有完成。所以我也會請米凱爾對此發表評論。但請不要閱讀任何有關全部數據的內容。

What I meant is that we are doing this, we are doing the release formulation so -- which will make it once a day, there are multiple things. But we need to wait and see, we see how competitors are doing before deciding what we will do. But the most important thing is to see what is the efficacy and safety of the study that will read out. So nothing to read in my comment on the totality of the data.

我的意思是我們正在做這個，我們正在做釋放配方——這將使它每天一次，有很多事情。但我們需要觀望，看看競爭對手的表現，然後再決定我們要做什麼。但最重要的是看看將讀出的研究的有效性和安全性如何。因此，我對全部數據的評論中沒有什麼可讀的。

So Mikael, do you want to add?

Mikael，你想補充嗎？

Yes, I think I'll echo what you said, Albert. We and I remain very enthusiastic to look forward to see the data. We have not seen the final top line report coming yet. So today, the study is still ongoing, but will be available before year-end. Then we will flip on -- as shown, as you know, some really interesting profile as a full agonist.

是的，我想我會同意你所說的，艾伯特。我們和我仍然非常熱衷於期待看到這些數據。我們還沒有看到最終的頂線報告。所以今天，這項研究仍在進行中，但將在年底前推出。然後我們將翻轉 - 正如所示，如您所知，一些非常有趣的配置文件作為一個完整的激動劑。

And it's our main opportunity and effort for obesity in type 2 diabetes. We got earlier today a question about new molecules that come in, and that's when I mentioned that our additional indications to pursue for such new molecules. And we also have new mechanisms that are validated that's coming in, in oral version. So we just punctate our big effort we have around both this class and obesity and other disorders.

這是我們治療第 2 型糖尿病肥胖的主要機會和努力。今天早些時候我們收到了一個關於新分子的問題，就在那時我提到了我們尋求此類新分子的額外跡象。我們也有經過驗證的新機制，以口頭形式推出。因此，我們只是強調我們圍繞著此類以及肥胖和其他疾病所做的巨大努力。

So in essence, he's still excited. Thank you very much, Mikael. Let's go to the next question, please.

所以本質上，他還是很興奮。非常感謝你，米凱爾。請讓我們進入下一個問題。

Next, we have Louise Chen with Cantor.

接下來是 Louise Chen 和 Cantor。

So I wanted to ask you on the fourth-generation PCV, how much additional serotype coverage will you have? And then also on Abrysvo, will that be available to pregnant women in the pharmacy? Or do they have to go to their OB/GYN? And then lastly, just on danuglipron again here, will you also have the modified release data before year-end?

所以我想問一下，關於第四代PCV，你們會有多少額外的血清型覆蓋率？還有 Abrysvo，孕婦可以在藥局購買嗎？或是他們必須去婦產科嗎？最後，再次在 danuglipron 上，您還會在年底前獲得修改後的發布數據嗎？

Mikael, you will take the PCV question and the danu. But also, Angela, very quickly, Abrysvo is available also in pharmacy...

Mikael，你將回答 PCV 問題和 Danu。而且，安吉拉，很快，Abrysvo 也可以在藥房買到...

Yes. It's going to be available in pharmacists, in doctors' offices, in OB/GYN offices. I think we have a real stocking advantage here, Louise, because anyone who just needs to stock one product hold two indications for both populations. So I think the uptake is to come. And certainly, the next few months being that it's the winter is when we begin to believe we'll see some good uptake.

是的。藥劑師、醫生辦公室、婦產科辦公室都可以使用它。路易絲，我認為我們在這裡擁有真正的庫存優勢，因為任何只需要庫存一種產品的人都擁有針對兩種人群的兩種適應症。所以我認為人們的接受即將到來。當然，接下來的幾個月是冬天，我們開始相信我們會看到一些好的吸收。

And then Mikael?

然後米凱爾？

On the PCV fourth generation, I hope you looked at today's data. And what you could see is that we are really the first company that has been able to put in place a whole set of new technology that can bring immune responses to a higher level than has been seen and that allow us to go with even more comprehensive coverage than the current 20. I'm not going to give your curiosity an answer, how many serotypes. I can just tell you, it's considerably more than the 20.

關於PCV第四代，希望大家能看一下今天的數據。你可以看到的是，我們確實是第一家能夠採用一整套新技術的公司，這些技術可以將免疫反應提高到前所未有的水平，並且使我們能夠採取更全面的方法覆蓋範圍超過目前的20。我不會回答你的好奇心，也就是有多少血清型。我可以告訴你，這比20多很多。

On danu, we look upon danuglipron as a once-a-day QD molecule because of the reformulation technologies that we have put in place and already generated some clinical data on and are now concluding. So that's really how we look upon danuglipron. And we'll have final data on the best formulation option early next year. But as Albert said, we're enthusiastic to look forward to the efficacy data later this year. So very exciting time.

在 Danu 上，我們將 danuglipron 視為每日一次的 QD 分子，因為我們已經實施了重新配製技術，並且已經產生了一些臨床數據，現在正在得出結論。這就是我們對 danuglipron 的看法。我們將在明年初獲得最佳配方選擇的最終數據。但正如阿爾伯特所說，我們熱切期待今年稍後的療效數據。非常激動人心的時刻。

Thank you very much, Mikael. Let's go to the next question.

非常感謝你，米凱爾。讓我們進入下一個問題。

Next, we have David Risinger with Leerink Partners.

接下來是 Leerink Partners 的 David Risinger。

So I have another question on danuglipron since it appears to be the company's #1 pipeline candidate based upon your forecasts. So regarding the Phase IIb results that are expected soon, how should we expect Pfizer to share those results?

因此，我對 danuglipron 有另一個問題，因為根據您的預測，它似乎是該公司排名第一的候選產品。那麼對於即將到來的IIb期臨床結果，我們該如何期待輝瑞分享這些結果呢？

And then with regard to the once-daily formulation that you just mentioned, Mikael, will that be ready for the Phase III start assuming that the company moves to start Phase III shortly after the Phase IIb results are generated?

然後，關於您剛才提到的每日一次的配方，Mikael，假設公司在 IIb 期結果生成後不久就開始啟動 III 期，那麼它是否為 III 期啟動做好了準備？

I mean the first question, given the importance of the marker, we would start with a press release, maybe call or not, I don't -- but with a press release, we would make them public available. Now Mikael, do you want to take the second part of the question?

我的意思是第一個問題，考慮到標記的重要性，我們將從新聞稿開始，可能會打電話，也可能不打電話，我不會——但透過新聞稿，我們會將它們公開。現在，Mikael，你想回答問題的第二部分嗎？

Yes. I can first echo what Albert and I said, we look forward with, as we said, to get the danuglipron obesity data later this year. And of course, as Albert said, pending totality of reviewing everything we have, we have made a lot of progress and been able to accelerate with the QD danu. Now we're waiting for some more clinical data early next year, but I think it's within our reach. If we decide to do -- to start the pivotal study next year, to do it with a once-a-day molecule.

是的。我首先可以回應阿爾伯特和我所說的，正如我們所說，我們期待在今年稍後獲得 Danuglipron 肥胖數據。當然，正如阿爾伯特所說，在全面審查我們所擁有的一切之前，我們已經取得了許多進展，並且能夠透過 QD danu 來加速。現在我們正在等待明年初更多的臨床數據，但我認為這是我們力所能及的。如果我們決定明年開始這項關鍵研究，用每天一次的分子來進行。

Thank you very much, Mikael. Let's go to the next question.

非常感謝你，米凱爾。讓我們進入下一個問題。

Next, we have Chris Schott with JPMorgan.

接下來是摩根大通的克里斯·肖特 (Chris Schott)。

Just two for me here. First, can you just comment a little bit more on what we're seeing with Nurtec and the ramp relative to your expectations? And maybe just as part of that, just any color on pricing we're seeing within the market today and how we should think about that going forward.

這裡只給我兩個。首先，您能否對我們在 Nurtec 上看到的情況以及相對於您的期望的增長發表更多評論？也許只是其中的一部分，我們今天在市場上看到的定價的任何顏色以及我們應該如何考慮未來的情況。

And then my second question was on 2024. I know you're not giving guidance today. But as you look at where consensus has kind of shaken out post the COVID and cost restructuring updates, I think the earnings are in kind of the low $3 range at this point, I guess just are there any directional kind of pushes or pulls in the numbers that you feel the Street isn't capturing properly and should be kind of thinking about before we get your kind of formal guidance as we look to early next year?

我的第二個問題是關於 2024 年的。我知道您今天沒有提供指導。但當你看到在新冠疫情和成本重組更新後共識已經動搖的地方，我認為目前的收益處於 3 美元的低位區間，我想是否存在任何方向性的推動或拉動您認為華爾街沒有正確捕捉到哪些數字，並且在明年初我們得到您的正式指導之前應該考慮一下這些數字？

Thank you. David, he's asking about '24 guidance, but you are not going to tell us?

謝謝。大衛，他在問 '24 指南，但你不打算告訴我們嗎？

Right. So obviously, it's a little early to 2024. I would just say that clearly, we had a clearing event as it relates to our COVID expectations for this year. So a lot of that risk is behind us as we think about the balance of this year. I do expect that the balance of this year will be very informative, particularly in the U.S. as we think about utilization trends, both for vaccination rates and importantly, Paxlovid here in the U.S., that will allow us to have a better clarity cycling 2024 of the utilization around those specific products, which will still be meaningful to us at an enterprise level.

正確的。顯然，現在距離 2024 年還為時過早。我只想說清楚，我們有一個清算活動，因為它與我們對今年的新冠病毒預期有關。因此，當我們考慮今年的餘額時，許多風險已經過去。我確實預計今年的剩餘時間將提供非常豐富的信息，特別是在美國，因為我們考慮使用趨勢，包括疫苗接種率，重要的是，美國的Paxlovid，這將使我們能夠更清楚地了解2024 年的循環情境圍繞著這些特定產品的利用，這對我們在企業層面仍然有意義。

Clearly, when we get to providing guidance, we'll give you a lot of information beneath that, so you can get a good sense of our -- importantly, our non-COVID products, which continue to trend very favorably and very well. And we can layer on, I'll say, the optionality associated with our COVID franchise as we cycle into next year. So obviously, a lot more to come. We're looking forward to sharing those very specific details after the first of the year.

顯然，當我們開始提供指導時，我們將為您提供大量信息，以便您可以很好地了解我們的——重要的是，我們的非新冠產品，這些產品的趨勢繼續非常有利和良好。我想說的是，隨著我們進入明年，我們可以疊加與我們的新冠專營權相關的選擇性。顯然，還會有更多的事情發生。我們期待在今年年初之後分享這些非常具體的細節。

Thank you, David. And then Angela, about the Nurtec launch -- about the Nurtec performance in the marketplace, including the price.

謝謝你，大衛。然後 Angela 介紹了 Nurtec 的發布，以及 Nurtec 在市場上的表現，包括價格。

Yes. So thanks for the question, Chris, because it's a great opportunity for us to share that we are seeing Nurtec perform just as we expected, in fact, with some really strong performance indicators that I'd like to share with you.

是的。謝謝你的提問，Chris，因為這是一個很好的機會讓我們分享我們看到 Nurtec 的表現正如我們預期的那樣，事實上，我想與您分享一些非常強大的績效指標。

First of all, from a TRx perspective, we grew 28% compared to last year this time. And sequentially, we grew 6% versus last quarter. In fact, on October 20, we saw the highest peak of TRxs and NRxs to date. That growth is also seen in the number of prescribers. Just this quarter alone, we had 73,000 prescribers writing Nurtec. And we are now moving at a clip of about 23,000 writers a week, which is 30% more than Ubrelvy and double that of Qulipta.

首先，從TRx的角度來看，我們這次比去年成長了28%。與上季相比，我們連續成長了 6%。事實上，10 月 20 日，我們看到了迄今為止 TRx 和 NRx 的最高峰。這種增長也體現在開處方者的數量上。光是本季度，我們就有 73,000 名處方者在使用 Nurtec。我們現在的速度是每週約 23,000 名作家，比 Ubrelvy 多 30%，是 Qulipta 的兩倍。

Another good place to look is also in new-to-brand starts, right, NBRxs. And when you look at that, NBRx growth for Nurtec is higher than Ubrelvy and Qulipta in all the deciles of physicians, but particularly in the decile 8 to 10, which, as you know, is where the highest prescribers are -- or who are the highest prescribers.

另一個值得關注的好地方也是新品牌的起步，對吧，NBRxs。當你觀察到這一點時，你會發現，在所有十分位數的醫生中，Nurtec 的NBRx 增長率都高於Ubrelvy 和Qulipta，特別是在8 到10 的十分位數中，正如你所知，這是開處方率最高的地方，或者說誰是開處方者。最高處方者。

And then when you look at pill count, we see something interesting there, too. We have been very intensely or intently driving our pill pack towards the larger co-pack size, which is the 16-pack because of our prevention indication. And so when you look at the totality of all the pills or the total volume of pills, we have a leading market share there, more than 50%.

然後，當你查看藥丸數量時，我們也會發現一些有趣的東西。由於我們的預防指示，我們一直非常強烈或專注地將我們的藥片包裝推向更大的聯合包裝尺寸，即 16 片裝。因此，當你看一下所有藥丸的總量或藥丸的總量時，我們在那裡擁有領先的市場份額，超過 50%。

And so I think when you look at all these indicators, at least on the way that we're looking at it, it's a very positive story. It's exactly how we see it. The expansion into primary care, as you heard in Albert's comments, is what it is that we're after. And today, only 17% of the entire market is all CGRPs, which tells you that most of the market is still an opportunity for us and represents growth that we're really looking forward to. And I think that we put the right investments in the right places to generate this growth in the future.

所以我認為，當你審視所有這些指標時，至少從我們看待它的方式來看，這是一個非常積極的故事。這正是我們所看到的。正如您在阿爾伯特的評論中聽到的那樣，擴展到初級保健是我們所追求的。而今天，整個市場中只有 17% 都是 CGRP，這告訴你，大部分市場對我們來說仍然是一個機會，代表著我們真正期待的成長。我認為，我們將正確的投資放在正確的地方，才能在未來實現這種成長。

From a pricing perspective, obviously, this is -- it's a product that is rebated. And so I think the way to think about it is that from a patient perspective, which is where we really put a lot of focus, we want to make sure that our patients are able to get these groups are able to get access for Nurtec, especially as you consider that we're trying to mobilize people away from Topiramate and away from triptan onto our CGRPs. So the gross to net effects here are significant, and you see that quarter-over-quarter because we are making sure that we are able to provide access to patients who deserve and are eligible for Nurtec.

從定價的角度來看，顯然，這是一種有折扣的產品。所以我認為思考這個問題的方法是從患者的角度來看，這是我們真正關注的地方，我們希望確保我們的患者能夠讓這些群體能夠獲得 Nurtec，尤其是當您考慮到我們正在努力動員人們遠離當托吡酯和曲坦類藥物時，他們會轉向我們的CGRP。因此，這裡的總淨效應是顯著的，並且您會看到季度環比，因為我們確保我們能夠為值得併有資格獲得 Nurtec 的患者提供服務。

Next, we have Mohit Bansal with Wells Fargo.

接下來是富國銀行的莫希特·班薩爾 (Mohit Bansal)。

Great. And I have a question regarding your S1P, etrasimod. Would love to get your thoughts on the label. It seems like -- I mean, you could avoid a lot of cardiac monitoring, but at the same time, there's this new requirement of like eye exam as well as skin exam. How do you think about uptake considering these examinations before the start of the treatment, given that these doctors are not used to it?

偉大的。我有一個關於您的 S1P、etrasimod 的問題。很想了解您對標籤的想法。看起來——我的意思是，你可以避免大量的心臟監測，但同時，還有像眼睛檢查和皮膚檢查這樣的新要求。鑑於這些醫生不習慣，您如何看待治療開始前的這些檢查？

All right. Mikael, Quite medical questions, would you like to answer it, please?

好的。 Mikael，這是一些醫學問題，您願意回答嗎？

I'm happy to start on it. I think we have a very robust label for etrasimod. It's only S1P in this drug class for ulcerative colitis that have a simple flat dosing and immediate start without any prior need for, let's say, cardiac rhythms exams like the other drugs in this class, or S1P have various eye exams to monitor. And I think our label similarly has a recommendation to do that.

我很高興開始這樣做。我認為我們有一個非常強大的 etrasimod 標籤。在此類治療潰瘍性結腸炎的藥物中，只有 S1P 具有簡單的固定劑量和立即開始治療，無需像此類中的其他藥物那樣事先進行心律檢查，或者 S1P 需要進行各種眼科檢查來監測。我認為我們的品牌也同樣有這樣做的建議。

So it's really nothing new. And our efficacy data, and you see has been very favorable. So we are very optimistic that this can be a true best-in-class in ulcerative colitis. Angela, do you want to add? Yes.

所以這確實不是什麼新鮮事。你看，我們的功效數據非常有利。因此，我們非常樂觀地認為，這可能是治療潰瘍性結腸炎的真正同類最佳藥物。安琪拉，你想補充嗎？是的。

Sure. I was just going to add to that, that -- I mean, competitively, we believe that we have an excellent efficacy and safety profile. We don't have a need to titrate up, as Mikael said, but also our assessments of standards versus our competitors at the initiation of therapy. So I think that this is a level playing field that we're in.

當然。我只是想補充一點，我的意思是，從競爭角度來看，我們相信我們擁有出色的功效和安全性。正如米凱爾所說，我們不需要進行滴定，但也需要在治療開始時與競爭對手進行標準評估。所以我認為這是一個公平的競爭環境。

Certainly, patient support is an area of focus for us, right, to ensure that patients are getting the assessments that they need. But we feel that we're -- this is pretty standard practice and we'll be able to launch this product as planned.

當然，患者支援是我們關注的一個領域，對吧，以確保患者得到他們需要的評估。但我們認為這是非常標準的做法，我們將能夠按計劃推出該產品。

Thank you very much, Angela. Next question, please.

非常感謝你，安吉拉。請下一個問題。

Next, we have Geoff Meacham with Bank of America.

接下來是美國銀行的傑夫‧米查姆 (Geoff Meacham)。

Just have a couple of quick ones. First, I noticed Seagen obviously hasn't closed yet, but does all the emphasis on ADCs from ESMO, does it affect how you guys prioritize the pipeline or maybe investments you could make today commercially?

只需要幾個快速的。首先，我注意到 Seagen 顯然還沒有關閉，但是 ESMO 對 ADC 的所有強調是否會影響你們如何優先考慮管道或今天可以進行的商業投資？

And the second question on danu. Mikael, I know a lot has been asked on the upcoming data. But from a commercial perspective, like where do you see the bigger opportunities for differentiation and metabolic? Is that really just oral administration in obesity? Or do you guys look more aggressively at related indications like cardio, renal, et cetera?

第二個問題是關於達努的。米凱爾（Mikael），我知道人們對即將發布的數據有很多疑問。但從商業角度來看，你認為差異化和新陳代謝的更大機會在哪裡？肥胖真的只是口服給藥嗎？或者你們是否更積極地關注相關適應症，如心臟、腎臟等？

Chris, do you want to take the question about the Seagen and the pipeline.

克里斯，你想回答有關 Seagen 和管道的問題嗎？

Thank you very much. Obviously, we remain very confident that we will close Seagen towards the end of this year, beginning next year. As you pointed out, there's a significant interest now in ADCs because of the potential that they could to place most of the chemotherapeutics in the future for most cancer types.

非常感謝。顯然，我們仍然非常有信心我們將在今年年底、明年開始關閉 Seagen。正如您所指出的，現在人們對 ADC 產生了濃厚的興趣，因為它們有可能在未來將大部分化療藥物用於大多數癌症類型。

Seagen, obviously, has a significant track record with 4 account-approved ADCs from their laboratories. And as you've seen, 3 potential registration trials just read out and Padcev to Kaiser and -- sorry, with Padcev and the -- but also with the small molecule to Kaiser.

顯然，Seagen 擁有來自其實驗室的 4 個帳戶批准的 ADC 的良好記錄。正如您所看到的，剛剛讀出了 3 個潛在的註冊試驗，並將 Padcev 發送給 Kaiser，抱歉，與 Padcev 和 - 但也將小分子發送給 Kaiser。

And they recently started 2 Phase III studies. One was the tisotumab vedotin in with -- in combination with pembrolizumab in advanced metastatic HER2 positive or HER2 bladder cancer. This is a program that we're very excited about, already tisotumab to seek previously processed [registration] in the U.S. And they're also just about to start another Phase III program in non-small cell lung cancer, with the B6 -- integrin beta 6 antibody. So we remain very confident in their portfolio and the depth of expertise they're bringing to the development and discovery of ADCs.

他們最近開始了兩項 III 期研究。其中之一是 tisotumab vedotin 與 pembrolizumab 合併治療晚期轉移性 HER2 陽性或 HER2 膀胱癌。這是一個我們非常興奮的項目，tisotumab 已經在美國尋求先前處理的[註冊]，他們也即將啟動另一個非小細胞肺癌的 III 期項目，其中包括 B6——整合素β6抗體。因此，我們對他們的產品組合以及他們為 ADC 開發和發現帶來的專業知識深度充滿信心。

Thank you. And then Mikael?

謝謝。然後米凱爾？

Yes, I think you asked about how could a new oral glip in obesity be positioned for maximum attractiveness and using danu as one example, pending, of course, our excitement to see the data. Well, clearly, as obesity and type 2 diabetes with overweight are moving from being treated from endocrinologists and metabolic physicians increasingly now to primary care, particularly with impressive effects of this drug has on obesity in body weight, all our agents in general are preferred.

是的，我想你問過如何將一種新的口服肥胖劑定位為最大吸引力，並以 Danu 為例，當然，等待我們看到數據的興奮。很明顯，隨著肥胖和超重2 型糖尿病的治療越來越多地從內分泌科醫生和代謝醫生轉向初級保健，特別是這種藥物對體重肥胖具有令人印象深刻的效果，我們所有的藥物總體上都是首選。

So I think a once-a-day drug such as the new reformulated potential danuglipron would have an interesting role there. I think there is also a growing discussion among opportunity leaders in the field that the patients, we gain weight when they stop injectables. And in general, they are only available for maybe a year. So an oral agent that could be taken for a longer period could also play a really interesting role to maintain body weight at the low level.

因此，我認為每日一次的藥物，例如新配方的潛在 danuglipron，將在其中發揮有趣的作用。我認為該領域的機會領導者之間也有越來越多的討論，即患者停止注射時我們的體重會增加。一般來說，它們的有效期限可能只有一年。因此，可以長期服用的口服藥物也可以發揮非常有趣的作用，將體重維持在較低水平。

And finally, you're absolutely right, the new data for this drug class suggests that patients could benefit from both cardiac and renal detection. And oral agents allow you to build combination with drugs that already used in this population such as to protect the heart, et cetera. So I think that's why there is such a big interest in drugs in this class. So thank you for the question.

最後，您是完全正確的，此類藥物的新數據表明患者可以從心臟和腎臟檢測中受益。口服藥物可以與該族群中已使用的藥物（例如保護心臟等）建立組合。所以我認為這就是人們對此類藥物如此大的興趣的原因。謝謝你的提問。

Thank you. Next question, please.

謝謝。請下一個問題。

Next, we have Tim Anderson with Wolfe Research.

接下來是沃爾夫研究中心的蒂姆·安德森。

I have a couple of questions. On danuglipron, the early data set showed a QTC signal. Do you think that was a red herring that won't show up in later data? To me, when I just think about drug classes and seeing QTC signals, it seems like it often persists in later data sets.

我有一些問題。在 danuglipron 上，早期數據集顯示了 QTC 訊號。您是否認為這是一個轉移注意力的事情，不會出現在以後的數據中？對我來說，當我只考慮藥物類別並看到 QTC 訊號時，它似乎經常持續存在於後來的資料集中。

And then second question on mRNA flu. You mentioned that safety is the same as licensed vaccines. Does that mean tolerability was as well? I usually think of safety and tolerability as technically being different from each other.

然後是關於 mRNA 流感的第二個問題。您提到安全性與許可疫苗相同。這是否意味著耐受性也很好？我通常認為安全性和耐受性在技術上是不同的。

Very good. Thank you very much for the question. Mikael, both questions for you. Could you say for danu and then tolerability on...

非常好。非常感謝你的提問。邁克爾，這兩個問題都問你。你能說是達努，然後是容忍度嗎？

Yes, I mean we have, I think, more than 1,400 patients on danuglipron and it's a very safe drug, it's a very safe drug, and we look forward to the readout and efficacy as we have said before year-end. So that's very straightforward.

是的，我的意思是，我認為我們有超過1,400 名患者在服用danuglipron，這是一種非常安全的藥物，這是一種非常安全的藥物，我們期待著結果和療效，正如我們在年底前所說的那樣。這非常簡單。

mRNA flu, you had a very good comment. Particularly in initial studies, tolerability is really what we focus on. And tolerability was similar to standard of care available vaccines or the other mRNA vaccines experienced from Pfizer, and we haven't really had any concerns about safety. So on both tolerability and safety, the statement stands that it looks like previous versions of our vaccines.

mRNA 流感，您的評論非常好。特別是在初步研究中，耐受性確實是我們關注的重點。耐受性與現有疫苗或輝瑞其他 mRNA 疫苗的護理標準相似，我們並沒有真正擔心安全性。因此，就耐受性和安全性而言，聲明認為它看起來就像我們疫苗的早期版本。

Thank you, Mikael, and let's go to the next question.

謝謝你，Mikael，讓我們進入下一個問題。

Next, we have Chris Shibutani with Goldman Sachs.

接下來是高盛的 Chris Shibutani。

Two questions, if I may. On the cost savings program, you've been outlining what the plan is for 2024. But if we look at the pattern of the spending for R&D and SI&A in the quarter you just reported, I would observe that the magnitude of reduction in the R&D spend was greater than expected relative to SI&A. How should we be interpreting those numbers? Is there anything to read across in terms of the relative amount of cost reductions coming from SI&A versus R&D on the forward?

如果可以的話，有兩個問題。關於成本節約計劃，您已經概述了 2024 年的計劃。但是，如果我們看看您剛剛報告的季度的研發和 SI&A 支出模式，我會發現研發的削減幅度相對於 SI&A 的支出高於預期。我們該如何解釋這些數字？就未來 SI&A 與研發帶來的成本降低相對量而言，有什麼值得一讀的事嗎？

And then a question on Abrysvo. First quarter sales were solid. Can you just elaborate how much may have been attributable to, for instance, inventory stocking versus actual demand? And if we look at prescription data, it looks like from the retail setting, there's about 30% market share. Is this similar to what you're observing in the broader market? And how is this comparing with your expectations?

然後是關於 Abrysvo 的問題。第一季銷售穩健。您能否詳細說明一下，有多少可能歸因於庫存庫存與實際需求等因素？如果我們查看處方數據，從零售環境來看，大約有 30% 的市場份額。這與您在更廣泛的市場中觀察到的情況相似嗎？這與您的期望相比如何？

Let me ask David to answer the question about R&D and SI&A expenses. And then Angela will take the...

讓我請 David 回答有關研發和 SI&A 費用的問題。然後安吉拉將採取...

Yes. Chris, on the cost program, I would not read into the allocation of savings in '23 as it relates to '24. Obviously, we have a fairly robust program up and running today. We're working aggressively on those programs and beginning to implement those programs. As we cycle into 2024, we'll give you and the market some specific color on how to think about those cost savings as we wrap into next year.

是的。克里斯，關於成本計劃，我不會解讀 23 年的節省分配，因為它與 24 年有關。顯然，我們今天已經啟動並運行了一個相當強大的計劃。我們正在積極致力於這些計劃並開始實施這些計劃。隨著 2024 年的到來，我們將為您和市場提供一些具體的信息，告訴您在明年即將到來時如何考慮這些成本節約。

Okay. Angela?

好的。安吉拉？

Sure. So we are really pleased with our performance on Abrysvo. It has exceeded our expectations. You first asked whether this is all about stocking and I can say that it isn't. Of course, there were stocking effects in the beginning because this was a new vaccine, but we're also closely tracking vaccination rates and uptake. And what you see is that there is a very fast uptake.

當然。所以我們對 Abrysvo 上的表現非常滿意。它已經超出了我們的預期。你先問這是否與襪子有關，我可以說不是。當然，一開始存在庫存效應，因為這是一種新疫苗，但我們也在密切追蹤疫苗接種率和接種率。你看到的是，人們的接受速度非常快。

We were -- that really benefited from the fact that this was approved and in market prior to the vaccination season actually happening. So it was able to ride off of the coattails of flu vaccinations, which you know are very high, right, September, October. We have about a 70% co-administration rate. So these -- the performance we're seeing on Abrysvo is truly driven by vaccinations.

我們確實受益於這一事實，即該藥物在疫苗接種季節實際發生之前就已獲得批准並進入市場。所以它能夠搭上流感疫苗接種的順風車，你知道九月、十月的疫苗接種率非常高，對吧。我們的共同給藥率約為 70%。因此，我們在 Abrysvo 上看到的表現確實是由疫苗驅動的。

To your comment about market share, yes, we are seeing a similar market share to what you have just said. That is because right now, the retail setting is driving a lot of the vaccinations. But don't forget, that, that's not where all vaccinations are taking place. We also have non-retail settings such as health systems, doctor's offices. Those are also being engaged and those particular settings, Pfizer actually has a leading preference. They are smaller in proportion but still, so I think we have to look at all channels of the market.

對於您對市場份額的評論，是的，我們看到的市場份額與您剛才所說的類似。這是因為目前零售環境正在推動大量疫苗接種。但不要忘記，這並不是所有疫苗接種的地方。我們還有非零售機構，例如衛生系統、醫生辦公室。這些也正在參與和那些特定的設置，輝瑞實際上具有領先的偏好。它們所佔的比例較小，但仍然如此，所以我認為我們必須關注市場的所有管道。

Finally, I think that just from a momentum perspective, we expect things to continue. The vaccinations really are happening throughout this time now, October, November, December are big vaccination months. From where we are right now, RSV is only 5% of the entire vaccination rate of the eligible population. So I think that the conclusion is we're very early in the innings of this launch, doing better than we thought. But where we are going to be, I think, is a place where there's tremendous opportunity for driving uptake in all the results, but also maternal, which, as you know, we just got the approval for.

最後，我認為僅從勢頭角度來看，我們預計事情會繼續下去。現在疫苗接種確實在這段時間進行，十月、十一月、十二月是疫苗接種的大月份。從目前情況來看，RSV 僅佔符合條件人口整體疫苗接種率的 5%。所以我認為結論是我們還處於這次發布的早期階段，做得比我們想像的要好。但我認為，我們將在一個地方，那裡有巨大的機會來推動所有結果的吸收，而且還有母性，正如你所知，我們剛剛獲得了批准。

Thank you. Next question, please.

謝謝。請下一個問題。

Next, we have Carter Gould with Barclays.

接下來是巴克萊銀行的卡特古爾德。

Maybe to go back to oral danu. When we do get the Phase II data, what should our expectation be around communicating plans for Phase III, which I guess is just a quicker way of saying, what's a reasonable expectation for how quickly you could turn around the Phase II and start a Phase III, and how much work Pfizer has already done on that front?

也許回到口頭達努。當我們確實獲得第二階段的數據時，我們對第三階段的溝通計劃的期望應該是什麼，我想這只是一種更快的表達方式，對於如何快速扭轉第二階段並開始第一階段的合理期望是什麼三、輝瑞在這方面已經做了多少工作？

And then maybe just coming out of ESMO, on the back of the EV-302 data and the response, would Pfizer say that reaffirms their expectations or represents upside to their expectations when the deal was originally announced?

然後，也許剛從 ESMO 出來，在 EV-302 數據和反應的支持下，輝瑞會說這重申了他們的預期，還是代表了他們最初宣布交易時的預期？

Thank you very much. On danu, let me take that so I can spare a little bit of Mikael's time. We are expecting the data to show up before the end of the year. And of course, it's an important event, so we will have to make it publicly known when we know the date. And of course, when we are ready with our Phase III, we hope that the data are good so that we can move into Phase III. And I hope that we are going to do it in an expedited manner because speed is of essence in this battle between competing molecules.

非常感謝。在達努，讓我接受這個，這樣我就可以騰出一點米凱爾的時間。我們預計數據將在年底前公佈。當然，這是一個重要的事件，所以當我們知道日期時，我們必須將其公開。當然，當我們準備好第三階段時，我們希望數據良好，以便我們可以進入第三階段。我希望我們能盡快做到這一點，因為在這場相互競爭的分子之間的戰鬥中，速度至關重要。

But we will announce our plans for Phase III. I know the interest is very high right now, but I won't be very prudent in not saying things without the data. [With data, with key data, we can revisit again]. Now let me move to Chris so that we can discuss about the ESMO.

但我們將宣布第三階段的計劃。我知道現在人們的興趣非常高，但在沒有數據的情況下我不會非常謹慎地不說話。 【有了數據，有了關鍵數據，我們就可以再回顧】。現在讓我請 Chris 來討論 ESMO。

Thank you for raising 301. These were truly monumental data for the field of bladder cancer and urothelial cancer. And as you pointed out, the overall survival and median progressive survival nearly doubled, moving median overall survival for this population now towards -- nearly towards 3 years. We expect the final number to be above, longer than 1.5 months. So this just reaffirms our beliefs that antibody drug conjugates could become a standard of care across the treatment paradigm for many, many different tumor types.

感謝您提出 301。這些對於膀胱癌和尿路上皮癌領域來說確實是具有里程碑意義的數據。正如您所指出的，總體生存期和中位進展生存期幾乎翻了一番，使該人群的中位總體生存期現在接近 3 年。我們預計最終數字將超過 1.5 個月。因此，這再次證實了我們的信念，即抗體藥物偶聯物可以成為許多不同腫瘤類型治療範式的護理標準。

Thank you very much. Next question, please.

非常感謝。請下一個問題。

Next we have Akash Tewari with Jefferies.

接下來是阿卡什·特瓦里 (Akash Tewari) 和傑弗里斯 (Jefferies)。

This is Ivy on for Akash. Our question is also on danuglipron. So starting once-daily modified release version, is there any possibility to do a bridging study for 2D formulation?

這是阿卡什的常春藤。我們的問題也是關於 danuglipron 的。那麼從每天一次的修改釋放版本開始，是否有可能對二維配方進行橋接研究？

And also for danu, I think as we've heard a lot of times on the call that the trial was marked as completed in October, I know you haven't seen the top line data. So at this point, are we waiting for data from this lower 4-week titration cohort? Also, would it be fair to say that you will have discontinued the program already if there were any clinically significant serious issues withstanding?

對於 Danu 來說，我認為我們在電話會議上多次聽到試驗被標記為 10 月完成，我知道您還沒有看到最重要的數據。那麼此時此刻，我們是否正在等待這個較低 4 週滴定隊列的數據？另外，如果存在任何臨床上重大的嚴重問題，可以公平地說您已經停止了該計劃嗎？

Mikael?

米凱爾？

Yes. On the once-a-day reformulated danu, we have initially tested a standard swellable-core technology and could show that it worked very well with danu. And now to be able also to incorporate a more sophisticated technology, we worked on a matrix technology and all data suggests it's going to be a really intriguing alternative.

是的。在每天一次的重新配製的 Danu 上，我們初步測試了標準的可膨脹核心技術，並且可以證明它與 Danu 配合得很好。現在，為了能夠融入更複雜的技術，我們研究了矩陣技術，所有數據表明這將是一個非常有趣的替代方案。

Because, as you know, in diabetes for all our drugs in obesity, you will, over time, end up with incorporating different drugs to prevent different downstream effects. And that's the beautiful of having this type of novel technology, that you have a potential in the future to go to fix those combinations. And we are really masters in developing sophisticated formulations, and we will have this available in 2024. And there was a second part, I think. Or no? There was a -- okay.

因為，如您所知，在糖尿病中，我們所有治療肥胖症的藥物，隨著時間的推移，您最終會合併不同的藥物以防止不同的下游效應。這就是擁有這種新技術的美妙之處，你將來有可能去修復這些組合。我們確實是開發複雜配方的大師，我們將在 2024 年推出該產品。我認為還有第二部分。或沒有？有一個——好吧。

Let's move to the Next question, please. Thank you, Akash (sic) [Ivy] , for your question.

讓我們轉到下一個問題。謝謝阿卡什（原文如此）[艾維]提出的問題。

Next, we have Kerry Holford with Berenberg.

接下來是凱瑞·霍爾福德和貝倫貝格。

Two questions on vaccines, please. Turning to RSV, in August, GSK filed a lawsuit against Pfizer alleging patent infringement. So I wonder if you could just talk to the next steps here, perhaps a time line that you anticipate for this. And should we think that this could ultimately result in some form of royalty payments to GSK?

請教兩個關於疫苗的問題。轉向RSV，8月份，葛蘭素史克對輝瑞提起專利侵權訴訟。所以我想知道您是否可以在這裡談談接下來的步驟，也許是您預計的時間表。我們是否應該認為這最終可能導致向葛蘭素史克支付某種形式的特許權使用費？

And then on Penbraya, how does the recent ACIP recommendation sit against your expectations for the sales ramp and peak potential for this vaccine? If the vaccine is effectively only used for dose 2 or 3, does that significantly reduce the commercial opportunity you had anticipated for the vaccine?

然後，在 Penbraya 上，最近的 ACIP 建議與您對該疫苗的銷售成長和高峰潛力的預期有何不同？如果疫苗僅有效使用第 2 劑或第 3 劑，這是否會顯著減少您預期的疫苗商業機會？

Yes. Doug, can you please answer the question about this legal situation with GSK.

是的。 Doug，您能回答一下有關 GSK 的法律情況的問題嗎？

Yes. So it's very, very early stages with respect to the RSV litigation. We have patents. We feel strongly about our own intellectual property, and it's certainly too early to say whether one party or the other will be required to pay any royalties or otherwise, very early stages in that regard.

是的。因此，RSV 訴訟還處於非常非常早期的階段。我們有專利。我們對自己的智慧財產權有著強烈的感情，現在就斷定一方或另一方是否需要支付任何特許權使用費或其他費用當然還為時過早，在這方面還處於非常早期的階段。

Thank you. And Angela, about Penbraya and how do you feel about it?

謝謝。安琪拉（Angela），關於彭布拉亞（Penbraya），你對此有何看法？

Sure. We continue to feel confident about the peak sales. The reason is that right now, we have the first set of recommendations. But ACIP has also told us that we will have the opportunity again to come back next year when we have additional data, which is when we'll have the opportunity to look at the schedule for how quads and these are being -- the schedule that they're being delivered today. And we'll have an opportunity again to take a look at the benefit of Penbraya in this population. So I feel like it's great that we have an opportunity to get out now and to begin vaccinating our teenagers. We'll have a second bite of the apple, which will allow us to achieve our peak sales.

當然。我們仍然對銷售高峰充滿信心。原因是現在我們有了第一組建議。但 ACIP 也告訴我們，明年當我們獲得更多數據時，我們將有機會再次回來，屆時我們將有機會查看四輪摩托車和這些項目的賽程表——他們今天就交付了。我們將有機會再次了解 Penbraya 對這一人群的好處。所以我覺得我們現在有機會出去並開始為我們的青少年接種疫苗真是太好了。我們將再咬一口蘋果，這將使我們能夠實現銷售高峰。

Thank you. Next question, please.

謝謝。請下一個問題。

Next, we have Andrew Baum with Citi.

接下來請來花旗銀行的安德魯·鮑姆 (Andrew Baum)。

Couple of questions. Would you comment on your stake in RVT-3101, the TL1A pending the approval of the licensing of the asset to Roche. Will you hang on to it? Or is that subject to divestment?

有幾個問題。您能否評論一下您在 RVT-3101 中的股份，TL1A 正在等待羅氏批准資產的許可。你會堅持下去嗎？或是是否可以撤資？

And then second question for Chris. Just looking at the recent EV-302 data and with -- you seem to have the Seagen portfolio. When you think about the combination of ADCs with pembro or with a PD-1, do you believe the efficacy that you're seeing is associated with the hedging? Or do you think it's true synergy through (inaudible)?

然後是克里斯的第二個問題。只要看看最近的 EV-302 數據，您似乎就擁有 Seagen 產品組合。當您考慮 ADC 與 pembro 或 PD-1 的組合時，您認為您所看到的功效與對沖有關嗎？或者您認為這是真正的協同作用（聽不清楚）？

Aamir, do you want to speak a little bit about the Roche acquisition of TL1A?

Aamir，您想談談羅氏收購 TL1A 的情況嗎？

Yes. So thanks for the question, Andrew. I think we're very pleased with the outcome of the TL1A program. When we created Televant, we did this as an R&D prioritization decision. Just as a reminder, this is a Phase II program that required significant Phase III investment. And so we held on to a 25% stake. We also had rights to royalties on U.S. sales as well as the full ex U.S. and ex Japan rights.

是的。謝謝你的提問，安德魯。我認為我們對 TL1A 計劃的結果非常滿意。當我們創建 Televant 時，我們將其作為研發優先決策。提醒一下，這是一個第二階段計劃，需要大量第三階段投資。所以我們保留了 25% 的股份。我們也擁有美國銷售特許權使用費以及美國和日本以外的全部權利。

And we did that all without any R&D spend. So Roche's proposed acquisition of Televant will give us access to about $1.75 billion of pretax cash, which is the translation of our stake. And we still retain all the other rights. So we're looking forward to having Roche as a partner. We're looking forward to the investments that they're going to make in advancing the clinical stage programs on TL1A and benefiting from the outcome of those.

我們在沒有任何研發支出的情況下做到了這一切。因此，羅氏擬收購 Televant 將使我們獲得約 17.5 億美元的稅前現金，這是我們股權的折扣。我們仍然保留所有其他權利。因此，我們期待羅氏成為合作夥伴。我們期待他們將在推進 TL1A 臨床階段計畫方面進行投資，並從這些計畫的成果中受益。

And Chris, about the synergies.

克里斯，關於協同作用。

Yes. Thanks, Andrew. That's a very good question. As you know, SUTENT pioneered the [MMAE] or statin-based payloads. And we see the potential synergy in combination with the PD-1 with ADCETRIS, with Tivdak and recently as you've seen with Padcev. Although Seagen does have the next generation of ADCs with [tuca 1] that will enter the clinic this year, next year, we don't know yet if the tuca 1s are going to show similar types of immunogenicity as what appears to happen with the MMAE or statin-based payloads. So I think we're very confident that, that Seagen has both tuca 1 as well as our statin-based payloads in case the tuca 1s, we do not what appears to be the correct type of...

是的。謝謝，安德魯。這是一個非常好的問題。如您所知，SUTENT 開創了 [MMAE] 或基於他汀類藥物的有效負載。我們看到了 PD-1 與 ADCETRIS、Tivdak 以及最近與 Padcev 結合的潛在協同作用。儘管 Seagen 確實擁有帶有 [tuca 1] 的下一代 ADC 將於今年、明年進入臨床，但我們尚不知道 tuca 1 是否會表現出與MMAE 或基於他汀類藥物的有效負載。因此，我認為我們非常有信心 Seagen 擁有 tuca 1 以及基於他汀類藥物的有效載荷，以防 tuca 1 看起來是正確類型的...

Thank you very much, Chris. And let's go to the last question, please.

非常感謝你，克里斯。請讓我們討論最後一個問題。

Our last question comes from Evan Seigerman with BMO Capital Markets.

我們的最後一個問題來自 BMO 資本市場的 Evan Seigerman。

So I have one on danu and then a bigger picture one. So a point of clarification on danuglipron. Mikael, is the ultimate goal to develop the fixed dose combination with, say, an SGLT2 or other anti-diabetes drugs? You kind of mentioned that in your commentary. And taking a big step back, how should we think about how you risk adjusted your long-term revenue guidance? Do you plan on updating these figures so you have clinical or regulatory successes or failures for example, with the approval of a...

所以我有一張關於達努的照片，然後是一張更大的照片。關於 danuglipron 有一點需要澄清。 Mikael，最終目標是開發與 SGLT2 或其他抗糖尿病藥物的固定劑量組合嗎？您在評論中提到了這一點。退一步來說，我們該如何考慮您如何調整長期收入指導的風險？您是否計劃更新這些數據，以便獲得臨床或監管方面的成功或失敗，例如，經過…的批准。

Mikael, can you please take the question?

邁克爾，你能回答這個問題嗎？

Yes. I mean the near-term goal is really look at the data, we've said both Albert and myself. And pending review, of course, that's an option with a once-a-day danu to move forward in obesity in diabetes. I think we have commented that the upside with oral drugs, our main in this sector, and that's why it has been such a big interest and that includes fixed dose combination, which aren't available with injectable. But we will keep it simple and clear. We'll review the data and take a decision about potential in obesity in diabetes once-a-day danu. That's the near-term.

是的。我的意思是，近期目標是真正關注數據，我們已經說過阿爾伯特和我自己。當然，正在等待審查，這是一種透過每天一次的 Danu 來推動糖尿病肥胖症治療的選擇。我認為我們已經評論過口服藥物的優勢，這是我們在這個領域的主要領域，這就是為什麼它引起如此大的興趣，其中包括固定劑量組合，這是注射劑所不具備的。但我們會保持簡單明了。我們將審查數據並就每天一次達努對糖尿病患者肥胖的可能性做出決定。這是近期的情況。

Thank you very much. And also about your question, if we are going to change the $20 billion or the $25 billion that we have declared. First of all, the $25 billion is billions that we are going to acquire in 2030. According to our estimates, we have acquired -- pending Seagen acquisition, $20 billion so far. If you see beyond the expectations for these acquisitions, at the end of 2030 are very, very close to what we have right now.

非常感謝。還有關於你的問題，我們是否要改變我們已經宣布的 200 億美元或 250 億美元。首先，250 億美元是我們將在 2030 年收購的數十億美元。根據我們的估計，到目前為止，我們已經收購了 200 億美元（待收購 Seagen）。如果您對這些收購的預期超出預期，那麼到 2030 年底，這些收購將非常非常接近我們現在的情況。

And I think there is -- this is trending very much. When you see internal pipeline of launches that we are having from our internal pipeline, which we declared at $20 billion, there is a gap between what we believe and what the analysts believe. And this is where we are functional. So right now, it's very early with the launches. Some of them are doing better than what we thought, some of them are doing worse than what we thought. And if we realize that the totality of $20 billion is not anymore what we think, of course, we will update.

我認為這是一個非常流行的趨勢。當你看到我們的內部管道中正在推出的產品時（我們宣布的規模為 200 億美元），我們的想法與分析師的想法之間存在差距。這就是我們發揮作用的地方。所以現在發布還為時過早。有些人的表現比我們想像的還要好，有些人的表現比我們想像的差。如果我們意識到 200 億美元的總金額不再是我們想像的那樣，我們當然會更新。

But I think what is important to that is if you look at our business, our core business is performing nicely. We continue to make traction. We have obviously a lot of launches that we completed and still several ahead of us. We're excited about what Seagen could potentially bring to the company as we think about our focus now in oncology.

但我認為重要的是，如果你看看我們的業務，我們的核心業務表現良好。我們繼續提供牽引力。顯然，我們已經完成了很多發布工作，而且還有一些工作要做。當我們考慮我們現在的重點是腫瘤學時，我們對 Seagen 可能為公司帶來的東西感到興奮。

And then importantly, I think we've baselined, if you will, the COVID franchise. Think about utilization in the back half of this year and cycle into next year, we will then take a step back and look at what would be prudent as we think about the revenue in totality of this company as we cycle into '24 and beyond. So I think look forward to, as we begin going into 2024, those expectations, laying those out specifically.

然後重要的是，如果你願意的話，我認為我們已經為新冠專營權制定了基線。考慮今年下半年的使用率並循環到明年，然後我們將退後一步，看看當我們考慮到這家公司的總收入時，當我們進入 24 世紀及以後時，什麼是謹慎的。因此，我認為，當我們開始進入 2024 年時，我們會期待這些期望，並具體闡述這些期望。

Okay. Thank you very much. So thank you. I would like just to say that if you walk away from today's call with just one take away, it should be that I think Pfizer's future remains bright. We have rebased our COVID expectations and now I think it's very easy for everyone to be able to model what I think will be stable COVID revenues going forward and with the recent -- particularly, the recent amended tax COVID supply agreement.

好的。非常感謝。所以謝謝。我只想說，如果您在結束今天的電話會議後只留下一件事，那就是我認為輝瑞的未來仍然光明。我們重新調整了對新冠病毒的預期，現在我認為每個人都可以輕鬆地對我認為未來穩定的新冠病毒收入進行建模，特別是最近修訂的新冠病毒稅收供應協議。

And of course, we are having a very strong performance of our new line and new products, the portfolio, excluding COVID, has 10% growth this quarter. And that positions us to be able to have growth going forward. So I will now bring this call to an end. Thank you for joining us, and have a great rest of your day.

當然，我們的新產品線和新產品表現非常強勁，除了新冠疫情外，我們的產品組合本季成長了 10%。這使我們能夠實現未來的成長。現在我將結束這通通話。感謝您加入我們，祝您有個愉快的一天。

Thank you, ladies and gentlemen. This concludes today's Pfizer Third Quarter 2023 Earnings Conference Call. We appreciate your participation, and you may disconnect at any time. Thanks.

謝謝你們，女士們、先生們。今天的輝瑞 2023 年第三季財報電話會議到此結束。我們感謝您的參與，您可以隨時斷開連線。謝謝。