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。我代表輝瑞團隊感謝您的加入。此次通話將透過 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。我們的收益資料可在 IR 網站 investors.pfizer.com 上查閱。

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；以及輝瑞研發部總裁 Mikael Dolsten 博士。參加問答環節的還有首席商務官兼全球製藥業務總裁 Angela Hwang；我們的首席商業創新官 Aamir Malik；我們的首席腫瘤學研究與開發官 Chris Boshoff 博士；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，我們將做出前瞻性的陳述。我鼓勵您閱讀投影片 3 上的免責聲明。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 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。

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

說完這些，我將把電話轉給阿爾伯特。

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 our North Star, 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，感謝大家今天加入我們。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，我們在腫瘤學、心血管疾病和抗感染等幾個關鍵治療領域中涵蓋了更多的患者。患者永遠是我們的北極星，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滿足患者需求的承諾。

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，輝瑞非 COVID 產品持續表現強勁，這令我們感到鼓舞，這些產品的營運收入與去年同期相比成長了 10%。我們看到新產品的推出以及幾個主要直列品牌的強勁同比增長做出了重大貢獻。

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。隨著最近批准的產婦適應症，輝瑞成為唯一一家獲得批准生產用於預防老年人呼吸道合胞病毒和嬰兒產婦免疫的呼吸道合胞病毒疫苗的公司。

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 80 million adults over age 60 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 將成為我們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，用一種疫苗保護兩個群體是可取的，也是 Abrysvo 的競爭優勢。光是在美國，就有大約 8,000 萬 60 歲以上的成年人有資格接種 RSV 疫苗，並且估計有 150 萬孕婦有資格在 2023 年 9 月至 2024 年 1 月期間接種 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治療方法，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 Triptans compared with approximately 1 million for oral CGRPs, which highlights a significant potential opportunity for growth.

初級保健顯然是偏頭痛市場潛在成長的來源。今年迄今，初級保健提供者開立了超過 610 萬張曲坦類藥物處方，而口服 CGRP 處方約為 100 萬張，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.

就 Oxbryta 而言，鐮狀細胞疾病患者面臨著巨大的疾病負擔和未滿足的需求。據估計，全世界有 1,200 萬人患有鐮狀細胞疾病 (SCD)，資源最匱乏的國家發生率最高。在美國，95% 的兒童可以活到成年，而其他地區 99% 的兒童會在五歲生日之前死亡，許多兒童甚至從未被診斷出患有疾病。

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。這一增長主要得益於轉甲狀腺素蛋白澱粉樣心肌病變適應症的持續強勁增長，主要是在美國和已開發歐洲。我們估計有 12 萬至 15 萬人患有 ATTR 心肌病變，其中大多數尚未被診斷。

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 products as the proven standard of care.

最大的未滿足需求仍然是缺乏對這種致命疾病的普遍了解和診斷能力，這就是為什麼我們專注於教育活動來擴大診斷並讓合適的患者接受產品治療作為經過驗證的護理標準。

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。我們的Prevnar系列產品Prevnar 13和Prevnar 20的全球營業收入與去年同期相比成長了15%。這一增長主要得益於美國患者對 Prevnar 20 成人藥物的強勁需求、美國對 Prevnar 20 兒童藥物的批准以及某些新興市場對 Prevnar 13 兒童藥物的庫存和增長。

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.

由於競爭激烈，Prevnar 兒科藥物在美國的市佔率預計會下降，但這一預期部分抵消了上述影響。值得注意的是，Prevnar 20 成人疫苗仍然是美國成人肺炎鏈球菌疫苗的領先者，第三季的市佔率為 95%。今年迄今，我們的非 COVID 產品的營運收入已成長 7%，我們仍有望在全年實現這些產品的營運收入成長 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新適應症的目標邁進。最近的里程碑包括：美國和歐盟批准並在孕婦中推出 Abrysvo；美國批准並上市治療復發難治性多發性骨髓瘤的Elrexfio；美國批准我們的 Braftovi 和 Mektovi 組合用於治療 BRAF 突變的轉移性非小細胞肺癌；美國批准 Velsipity 用於治療中度至重度潰瘍性疫苗是一種嚴重潰瘍性疾病； 0 至 25 歲青少年和青年中最常見的 5 種導致腦膜炎球菌疾病的血清群。

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，我們已執行了最初確定的 19 個潛在發布項目中的 13 個，另有 4 個產品已獲批准並正在為發布做準備。事實上，從技術角度來看，剩餘的 6 項潛在發射中，有 5 項已基本消除風險。剩下的就是我們的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.

鑑於我們最近從下一代 mRNA 流感/COVID 組合候選藥物中取得的積極成果以及我們針對 65 歲及以上人群的第一代、前 3 個獨立 mRNA 流感研究的待定結果，我們獨立 mRNA 流感藥物的上市時間預計在 2024 年之後。如果成功，我們的下一代 mRNA 流感/COVID 組合候選藥物預計將於 2025 年上市。 Mikael 很快就會分享有關這些計劃的更多資訊。

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.

我們對於擬議的 Seagen 收購案以及我們認為這一結合將對人類健康產生的巨大影響感到興奮。每三分之一的人一生中都會被診斷出罹患癌症。因此，攻剋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批准，我們繼續預計交易將在 2023 年底或 2024 年初完成，但須遵守慣例成交條件，包括美國聯邦貿易委員會的批准。

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，我們已經籌集了 310 億美元的收購融資，並繼續預計 2030 年風險調整後收入增量將超過 100 億美元，預計成本效率將達到 10 億美元，並在交易結束後第三年年底實現，而不會影響任何研發計劃。

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

說完這些，我會把話題交給戴夫。 Dave 之後，Mikael 將提供我們研發管道的最新進展。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，阿爾伯特，早安。在回顧本季的業績之前，我將先討論自 10 月 13 日宣布業績以來投資者最關注的幾個主題。這些主題涉及我們未來美國政府 Paxlovid 的收入預測以及我們的多年成本調整計劃。

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，我們將在 2023 年底獲得約 42 億美元的基於數量的信貸，用於未來的治療課程。輝瑞也將向美國國家戰略儲備額外提供100萬個療程的疫苗。

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 萬個療程，從 2024 年開始，我們將在提供這些療程的同時記錄約 42 億美元的收入。值得注意的是，對於預計進行的890萬個療程的治療，並沒有提供現金補償。

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，我們預計到 2024 年底將實現至少 35 億美元的淨成本節約，而我們的 2023 年 8 月 1 日 SI&A 和研發指導的中點則為如此。我們預計 2023 年的目標節省金額為 10 億美元，預計 2024 年將額外節省至少 25 億美元。稍後，當我回顧我們 2023 年全年指引的組成部分時，您會看到我們分別將 SI&A 和 R&D 指引範圍的中點降低了 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.

現在轉向本季。我們的第三季業績（包括營收和淨利）均受到 COVID 產品的嚴重負面影響。由於 Paxlovid 和 Comirnaty 銷售額下降，營運收入下降了 41%，而調整後每股攤薄虧損也受到了 56 億美元 COVID 相關庫存非現金庫存註銷的嚴重影響。

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，第三季我們產品的營業收入成長（不包括 Paxlovid 和 Comirnaty）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。本季度我們報告的每股攤薄虧損為 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 COVID 相關庫存註銷相關的非現金費用造成的。

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 的 47 億美元庫存註銷和 Comirnaty 的 9 億美元庫存註銷對調整後每股虧損產生了 0.84 美元的負面影響。外匯變動對第三季營收產生了微不足道的不利影響，與 LY 相比，調整後每股攤薄虧損增加了 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。鑑於我們在 10 月 13 日更新了全年收入和每股盈餘指引，我只介紹其中的幾個重點。預計該公司 2023 年全年總營收將在 5,800 萬美元至 610 億美元之間，而先前的預期為 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 COVID 產品的全年營業收入將年增 6% 至 8%。如預期，考慮到新產品和預定發布的時機，大部分成長將發生在下半年。

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在 41% 至 43% 之間，這主要是由於與我們 COVID 產品庫存註銷相關的 56 億美元非現金費用。

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 R&D 費用預計在 119 億美元至 129 億美元之間。現在兩個範圍的中間值比我們最初的預期低 5 億美元。綜合考慮上述因素，公司現預計全年調整後每股攤薄收益在 1.45 美元至 1.65 美元之間，而原來的預期範圍為 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都包含在我們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大核心支柱：首先是對我們的業務進行再投資；第二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，我們在內部研發上投資了 79 億美元，透過季度股息向股東返還了 69 億美元，並向擬議的 Seagen 收購撥款約 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，我們還準備在滿足所需的成交條件後執行剩餘的短期融資以完成擬議的 Seagen 收購。我們預計此次交易完成後我們的資本結構將會降低。隨著我們去槓桿，我們預計將恢復更均衡的資本配置策略，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 COVID 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，從而提升長期股東價值。

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

現在，讓我把話題交給米凱爾。

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 合作針對高毒性病毒的 mRNA 平台、我們的亞基平台針對在不同季節保持相對一致的病毒，以及我們的結合疫苗平台，旨在幫助預防細菌感染。

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 批准基於各個平台的疫苗，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候選疫苗、流感/COVID 聯合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 3 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 3 期流感試驗的 18 至 64 歲人群中都實現了兩個主要終點。在試驗中，我們的第一代 mRNA 流感候選疫苗在初步分析時表現出與已獲得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 的流感疫苗候選物的有效性和優越性。

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，我們的候選藥物的療效透過試驗的賽季結束分析得以維持，且其效果不劣於獲得許可的對照藥物。安全性與標準流感疫苗相似。從 A 類和 B 類情況綜合考慮的主要和賽季末療效分析。

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 3 study also include a 65-year and older cohort that we previously shared encouraging T cell data for all 4 strains from the Phase 2 study in this cohort.

我們試驗中以及整個 22/23 流感季節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，與已獲許可的流感疫苗相比，針對甲型流感的抗體反應更為強勁。針對乙型流感的體液反應低於對照劑所達到的水平。回想一下，我們的獨立流感疫苗第 3 階段研究還包括一個 65 歲及以上的群體，我們先前分享了該群體第 2 階段研究中的所有 4 種菌株的令人鼓舞的 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的季節性流感疫苗的功效，特別是對於 65 歲及以上的人。我們預計今年稍後我們會公佈這個年齡組的數據。為了解決第一代獨立流感候選藥物 B 反應較低這個問題，輝瑞公司創造了下一代配方。它們與輝瑞 BioNTech COVID-19 疫苗結合，被納入我們的 mRNA 流感候選疫苗中，我現在將對其進行回顧。

In positive Phase 1/2 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 3. 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 1/2 期正面頂線數據中，我們觀察到主要流感候選藥物的配方改進了 BioNTech 對乙型流感病毒的治療效果，使我們能夠滿足進入第 3 期的所有標準。在試驗中，我們的主要候選製劑誘發了強大的免疫反應，幾何平均滴度比的點估計值與針對所有匹配的流感和 SARS-CoV2 株的已批准疫苗的一致標準一致。

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 3 study in the coming months.

值得注意的是，對於所有匹配的流感疫苗株，所選候選製劑的幾何平均滴度比的點估計值相對於其許可的比較劑均大於一。所評估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啟動第三階段研究。

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特許經營權是當務之急，因為它可能讓我們能夠利用美國成年人每年近 50% 的流感疫苗接種率。

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.

為了實現這一目標，我們採取了差異化的方法，利用了 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，以潛在幫助預防流感、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。首先我要提醒大家，這是唯一一家獲得 FDA 核准用於治療成人肺炎的 PCV 企業。提供對肺炎球菌性肺炎的專門保護至關重要。它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。在美國 50 歲以上的成年人中，非菌血症性肺炎鏈球菌肺炎的盛行率比侵襲性肺炎球菌疾病的盛行率高出 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，該試驗由肺炎球菌疫苗人群和專有檢測方法支持。鑑於目前肺炎鏈球菌疫苗覆蓋率很高，這些創新特點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。我們的目標是盡可能地提高效價並提高免疫原性，同時保持臨床證明可以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.

為了履行這項承諾，我們一直在開發第四代 PCV 候選藥物，該藥物以 Prevnar 業務 20 多年的創新為基礎。我們的下一代技術利用尖端的結合、化學、載體和配方。利用這些新的專有疫苗技術，我們在單價 I 期研究中觀察到選擇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，我們有可能實現更高的效價和更好的血清分型免疫原性。我們目前正在推進第四代候選藥物的首次人體試驗，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列表，並重點介紹最近批准用於治療潰瘍性結腸炎的 Velsipity 和首個五價腦膜炎雙球菌疫苗 Penbraya。光是今年，輝瑞就已獲得十多項監管部門的批准。我還要指出的是，最近推出了用於母體免疫的 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。讓我把話題轉回給法蘭西斯卡，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。現在，讓我們開始問答環節。我們將在時間允許的範圍內回答盡可能多的問題，通話結束後 IR 也會回答任何後續問題。接線員，請集合排隊。

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

(操作員指示) 我們的第一個問題來自 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?

我認為我對你們的新產品有一個宏觀問題，這對你們的發展極為重要。我認為，您是否看到了疫苗疲勞的影響，就像我們在 COVID 中看到的對呼吸道合胞病毒和肺炎球菌疫苗的影響一樣？當您考慮 2023 年和 2024 年時，您如何看待這種影響？您認為它會消散嗎？

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 RSV, we have COVID, we have pneumococcal in the respiratory front.

感謝您的提問。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，因為我們有呼吸道合胞病毒，有新冠肺炎，在呼吸道方面我們有肺炎球菌。

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 payers with zero co-pay 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在於我們是否擁有組合產品。我們認為，組合產品將——由於其便利性，由於疫苗受到零自付費用的支付者的青睞，並且由於一次注射的便利性，基本上會增加所有疫苗的數量和接種率。我想這就是你從邁克爾那裡看到的原因，我們目前所有的努力都在開發多種組合，以便消費者和醫生能夠選擇使用哪種組合，並且始終保持相同的便利性。

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

我想我們可以進入下一個問題。非常感謝，羅賓。

Our next question will come from Huynh Trung with UBS.

我們的下一個問題來自瑞銀的 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?

我有一個關於流感的，然後只有一個關於 danu 的。那麼關於流感，您能否確認 18 至 64 歲以及 64 歲年齡組的對照組是低劑量流感疫苗？ FDA 是否可能需要高劑量流感疫苗的數據？從商業角度來看，考慮到 CDC 對老年族群的建議，您是否認為仍需要高劑量流感數據（與高劑量流感數據進行比較）？

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 3 trials? Is something similar to the Phase 2 we saw earlier this year enough to move it to Phase 3?

然後關於 danu，我們是否應該——僅根據我們預計年底前獲得的數據，您需要展示什麼才能將其推進到第 3 階段試驗？與我們今年早些時候看到的第二階段類似的事情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 population, we are having studies now with the low dose, but we will do also with the higher dose. So we have both.

謝謝。與流感相比，我可以確認，對於年輕族群來說，這是低劑量，因為這是唯一允許的劑量。因此，針對老年族群，我們現在正在採用低劑量進行研究，但我們也會採用高劑量進行研究。因此我們兩者皆有。

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 intensively to be able to have this data presented before year-end.

關於 danu，沒有什麼好說的。我們需要等待才能看到數據。顯然，當您推進這樣的程序時，您需要查看全部數據。我們現在正在加緊努力，以便在年底之前提供這些數據。

Let's move to the next question.

我們來討論下一個問題。

Our next question will come from Umer Raffat with Evercore.

我們的下一個問題來自 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 1. 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 2 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這個主題。我注意到你們將一個新的分子 522 移入了第 1 階段。我的問題是，它的化學結構和化學系列是否類似於 danu 和 lotiglipron 程式？另外，阿爾伯特，你提到你想等待查看 Danuglipron 第 2 階段的數據，但我意識到試驗已經結束了幾個星期。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。米凱爾，你想回答有關新分子和達努的問題嗎？

Yes. We are building a platform around the GLP 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 GLP 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 GLP 領域以及肥胖症領域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 的讀數，這是我們獲取數據以審查 2 型糖尿病肥胖症的主要機會。但有許多跡象表明，GLP 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。你也會看到輝瑞公司推出更多新機制。我們在這裡做出了相當大的努力。謝謝。

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. 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?

對我來說也許是 2。我只是想知道，在您推出 RSV 疫苗時，我們應該如何看待 2024 年重新接種疫苗的可能性。然後，關於您的 DMD 基因治療計劃，我想您之前談到在年底前獲得中期數據。現在還是這樣嗎？最近的競爭對手的數據是否會讓您對自己的計劃更加樂觀或不那麼樂觀？

Thank you very much. First of all, let me make a comment on the recent data that we saw about the DMD failure. It's very, very bad news for patients. We are really -- at least the patient population 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 故障的數據發表一下評論。這對患者來說是一個非常非常壞的消息。我們確實——至少是沒有解決方案的患者群體，我希望透過 FDA 的討論能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。米凱爾，為什麼不先從 DMD 開始，然後，安琪拉，再去 RSV 呢？

Yes, I echo Albert's comment that we are always sad when -- someone fails a 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，我同意阿爾伯特的評論，當有人學習失敗時，我們總是感到難過。我們對於這項結果感到非常高興。你說得對，年底左右有機會進行中期分析，最終分析將在明年下半年進行。總的來說，我認為我們的 DMD 基因療法在生物標記和功能終點方面表現出非常一致的效果。

And what has 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.

到目前為止的不同之處在於，當您查看我們報告的功能數據時，它會對年齡較小的男孩和年齡稍大的男孩發出令人鼓舞的信號，而您提到的其他公司並沒有出現這種情況。因此，從某種程度上來說，我仍然像之前一樣，非常積極地期待數據結果，並讓數據告訴你故事。但當然，這使得我們的基因療法在某種程度上成為了主流。

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——共享臨床決策。但我們也被要求在準備好時提供更多數據。這只是為了確認我們將獲得更多有關更廣泛人群中疫苗有效性的數據。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 CDC 時投入使用。除此之外，其實我需要提一下，我們還會有第二季的功效數據。因此，我們將能夠匯總所有這些數據，以確定建議是否會改變，以及疫苗接種時間表將是什麼。所以這將在 2024 年實現。

Next, we have Steve Scala with TD Cowen.

接下來是 TD Cowen 的 Steve Scala。

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.

正如幾分鐘前我們剛剛指出的那樣，danu 數據已初步完成。那是好久以前的事了。阿爾伯特，當你被問到這個問題時，你強調了「數據總體」這個詞，這意味著你可以看到數據中的某些部分。米凱爾，當你被問到這個問題時，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.

這些並不是建立信任的聲明。所以我很好奇你看到了什麼。米凱爾，您過去曾說過，您對 Danu 的形象非常鼓舞，並且充滿信心。您是否仍充滿信心和鼓舞？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可能由於 COVID 而導致的 UC 等發炎性疾病診斷的下降。我想知道您是否見過這些。

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，我想你可能誤解了我對整體的評論。這與我所見過的任何數據都無關，因為我沒有見過，對嗎？因此數據尚未呈現——我認為研究尚未完成。因此我也將請米凱爾對此發表評論。但請不要閱讀有關全部數據的任何內容。

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這樣做，我們正在進行發布配方，這樣每天就會有一次，會有多種事情。但我們需要拭目以待，看看競爭對手的表現如何，然後再決定我們要做什麼。但最重要的是看讀出的研究的功效和安全性是如何的。因此，我對全部數據的評論沒有什麼可讀的。

So Mikael, do you want to add?

那麼 Mikael，你想補充嗎？

Yes, I think I'll echo what you said so well there, 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. Danuglipron -- has shown, as you know, some really interesting profile as a full agonist.

是的，我想我會重複你所說的話，阿爾伯特。我們和我依然非常熱切地期待看到這些數據。我們尚未看到最終的頂線報告。所以今天，這項研究仍在進行中，但將在年底前完成。 Danuglipron——如您所知，作為一種完全激動劑，已經表現出一些非常有趣的特性。

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 punctuate our big effort we have around both this class and obesity and other disorders.

這是我們針對第 2 型糖尿病肥胖症的主要機會和努力方向。今天早些時候，我們收到了一個關於新分子的問題，當時我提到了我們要尋求這種新分子的額外指徵。我們也有經過驗證的新機制，以口頭版本的形式推出。因此，我們只是強調了我們在這一類別以及肥胖症和其他疾病方面所做的巨大努力。

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

所以從本質上來說，他仍然很興奮。非常感謝，米凱爾。請我們進入下一個問題。

Next, we have Louise Chen with Cantor.

接下來我們有幸請到 Cantor 的 Louise Chen。

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，你們的額外血清型覆蓋範圍是多少？還有 Abrysvo，藥局可以給孕婦買嗎？或是他們必須去看婦產科嗎？最後，再次詢問 Danuglipron，您是否也會有年底前的修改後發布數據？

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

米凱爾，你將回答 PCV 問題和 danu 問題。而且，安吉拉，很快，Abrysvo 也可以在藥局買到了...

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 for 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。它將在藥劑師、醫生辦公室和婦產科辦公室提供。路易絲，我認為我們在這裡有真正的庫存優勢，因為任何人只需要為兩種人群儲備一種產品。所以我認為這種趨勢即將出現。當然，接下來的幾個月是冬季，我們開始相信我們會看到一些好的成長。

And then Mikael?

然後是米凱爾？

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，我希望您看了今天的數據。你們可以看到，我們確實是第一家能夠實施一整套新技術的公司，這種技術可以將免疫反應提升到前所未有的水平，讓我們的覆蓋範圍比目前的 20 種更全面。我不會回答你的好奇心，有多少种血清型。我只能告訴你，這個數字遠超過 20。

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 方面，我們將 danuglipron 視為每日一次的 QD 分子，因為我們已經採用了重新配製的技術，並且已經產生了一些臨床數據，現在正處於總結階段。這就是我們對 danuglipron 的看法。我們將於明年初獲得最佳配方方案的最終數據。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，米凱爾。我們來看下一個問題。

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 2b 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藥物。那麼，對於即將公佈的 2b 期結果，我們應該期待輝瑞如何分享這些結果？

And then with regard to the once-daily formulation that you just mentioned, Mikael, will that be ready for the Phase 3 start assuming that the company moves to start Phase 3 shortly after the Phase 2b results are generated?

然後關於您剛才提到的每日一次的配方，Mikael，假設公司在第 2b 階段結果生成後不久就開始第 3 階段，那麼這是否為第 3 階段的開始做好了準備？

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

我的意思是第一個問題，考慮到市場的重要性，我們將從新聞稿開始，也許打電話或不打電話，我不知道 - 但透過新聞稿，我們將將它們公開。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。我首先要重複艾伯特和我所說的話，正如我們所說的，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，在對我們所擁有的一切進行全面審查之後，我們已經取得了很大進展，並且能夠加速 QD danu 的進程。現在我們正在等待明年初的更多臨床數據，但我認為這是可以實現的。如果我們決定——明年開始這項關鍵研究，那麼將使用每天一次的分子進行研究。

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

非常感謝，米凱爾。我們來看下一個問題。

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.

這裡只有兩個給我。首先，您能否就 Nurtec 的現狀以及相對於您的預期的成長情況再發表一些評論？也許只是其中的一部分，只是我們今天在市場上看到的任何定價因素，以及我們應該如何看待未來的定價因素。

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。我知道您今天不會提供指導。但是，當您看到在 COVID 和成本重組更新之後共識發生了怎樣的變化時，我認為目前的收益大約在 3 美元的低位，我想您覺得這些數字中是否存在任何方向性的推動或拉動因素，而華爾街沒有正確捕捉到這些因素，在我們展望明年年初之前獲得您的正式指導之前，應該考慮一下這些問題嗎？

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

謝謝。大衛，他問的是有關 24 條指導意見，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。因此顯然，到 2024 年還為時過早。我只想說，很明顯，我們有一個清算事件，因為它與我們對今年的 COVID 預期有關。所以，當我們考慮今年的平衡時，很多風險已經被我們拋在腦後了。我確實希望今年的平衡數據將非常有益，特別是在美國，因為我們考慮了利用趨勢，包括疫苗接種率，以及重要的，美國的 Paxlovid，這將使我們能夠更清楚地了解 2024 年這些特定產品的利用率，這對我們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，當我們提供指導時，我們會向您提供大量信息，以便您能夠很好地了解我們的——重要的是，我們的非 COVID 產品繼續呈現非常有利和良好的趨勢。我想說，隨著我們進入明年，我們可以分層增加與我們的 COVID 特許經營相關的可選性。顯然，接下來還會有更多。我們期待在新年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。然後是安吉拉，關於 Nurtec 的發布——關於 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。感謝克里斯提出這個問題，因為這對我們來說是一個很好的機會，我們可以分享我們看到的 Nurtec 的表現正如我們預期的那樣，事實上，它有一些非常強勁的績效指標，我想與大家分享。

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，我們這次比去年增加了28％。與上一季相比，我們的成長了 6%。事實上，10 月 20 日，我們看到了迄今為止 TRxs 和 NRxs 的最高峰值。這種成長也體現在開處方人數。僅本季度，我們就有 73,000 名處方人員開出了 Nurtec。目前，我們每週的寫作速度約為 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是新品牌的啟動，對吧，NBRxs。從這個角度來看，Nurtec 的 NBRx 成長率在所有醫生十分位數中都高於 Ubrelvy 和 Qulipta，尤其是在 8 到 10 十分位數，正如你所知，這些十分位數是開處方最多的地方——或者說是開處方最多的地方。

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%.

當您查看藥丸數量時，我們也會發現一些有趣的東西。由於我們的預防指徵，我們一直非常積極或專注地推動我們的藥丸包裝向更大的聯合包裝尺寸發展，即16片裝。因此，當您查看所有藥丸的總量或藥丸的總量時，我們的市佔率領先，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 oral 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.

因此我認為當你看看所有這些指標時，至少從我們的角度來看，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所聽到的，我們所追求的就是擴展到初級保健。如今，口服 CGRP 僅佔整個市場的 17%，這說明大部分市場對我們來說仍然是一個機會，也代表著我們真正期待的成長。我認為我們在正確的地方進行正確的投資將能夠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 Triptans 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.

從定價角度來看，顯然，這是——一種有折扣的產品。因此，我認為應該從患者的角度來思考這個問題，這也是我們真正關注的重點，我們希望確保我們的患者能夠獲得 Nurtec，尤其是考慮到我們正試圖動員人們遠離托吡酯和曲坦類藥物，轉而使用我們的 CGRP。因此，這裡的總淨效應非常顯著，而且您會看到這一季度環比增長，因為我們確保能夠為值得且有資格獲得 Nurtec 的患者提供治療。

Next, we have Mohit Bansal with Wells Fargo.

接下來是富國銀行的 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。我對您的 S1P etrasimod 有一個疑問。很想聽聽您對這個標籤的看法。看起來——我的意思是，你可以避免很多心臟監測，但同時，還有像眼科檢查和皮膚檢查這樣的新要求。考慮到這些醫生不習慣在治療開始前進行這些檢查，您如何看待這種治療方法？

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

好的。米凱爾，有一些醫學問題，你願意回答嗎？

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, all S1Ps have various eye exams to monitor. And I think our label similarly has a recommendation to do that.

我很高興開始做這件事。我認為我們對 etrasimod 有一個非常強大的標籤。在這一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，可以立即開始治療，而不需要像這一類中的其他藥物那樣進行心律檢查，所有 S1P 都需要進行各種眼科檢查以進行監測。我認為我們的標籤也同樣建議這樣做。

So it's really nothing new. And our efficacy data in UC 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.

所以這真的不是什麼新鮮事。我們在 UC 方面的療效數據非常好。因此，我們非常樂觀地認為這將成為治療潰瘍性結腸炎的真正最佳藥物。安琪拉，你想添加嗎？是的。

[Pfizer has a clarification on the above comment by the Pfizer spokesperson regarding pre-treatment exams for VELSIPITY. The VELSIPITY label does not require cardiac rhythm exams following treatment initiation. However, as for other S1Ps, an electrocardiogram should be obtained to assess for preexisting cardiac conduction abnormalities before starting treatment with VELSIPITY. See USPI for additional safety information.] (added by company after the call)

[輝瑞對輝瑞發言人關於VELSIPITY治療前檢查的上述評論作出了澄清。 VELSIPITY 標籤並不要求在開始治療後進行心律檢查。但是，與其他 S1P 一樣，在開始使用 VELSIPITY 治療之前，應進行心電圖檢查以評估是否有心臟傳導異常。請參閱 USPI 以了解更多安全資訊。 ]（公司在通話後添加）

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，從競爭力上講，我們相信我們具有出色的功效和安全性。正如米凱爾所說，我們不需要逐步提高劑量，而且在治療開始時，我們也要對與競爭對手的標準進行評估。所以我認為我們處在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領域，以確保患者得到他們需要的評估。但我們覺得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，安吉拉。請回答下一個問題。

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?

只需快速吃幾個即可。首先，我注意到 Seagen 顯然還沒有關閉，但 ESMO 對 ADC 的所有重視是否會影響你們如何確定產品線的優先順序，或者可能影響你們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 danu 的。米凱爾，我知道很多人問到即將公佈的數據。但從商業角度來看，您認為差異化和代謝的更大機會在哪裡？治療肥胖症真的只需要口服藥物嗎？或者你們是否更積極地關注心臟、腎臟等相關適應症？

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 replace 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在今年年底或明年年初關閉 Seagen。正如您所指出的，目前人們對 ADC 產生了濃厚的興趣，因為它們有可能在未來取代大多數癌症類型的大部分化療藥物。

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

顯然，Seagen 擁有卓越的業績記錄，其實驗室目前已生產 4 種核准 ADC。正如您所看到的，剛剛讀出的 3 項潛在註冊試驗是 Padcev、Tukysa 和——抱歉，還有 Padcev 和 Tivdak——還有小分子 Tukysa。

And they recently started 2 Phase 3 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 (inaudible) in the U.S. And they're also just about to start another Phase 3 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第三階段的研究。一種是將 tisotumab vedotin 與 pembrolizumab 聯合用於治療晚期轉移性 HER2 陽性或 HER2 膀胱癌。這是一個讓我們非常興奮的項目，tisotumab 已經在美國尋求先前處理的（聽不清楚）。他們也即將啟動另一個針對非小細胞肺癌的 3 期項目，使用 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 的開發和發現帶來的專業知識深度仍然非常有信心。

Thank you. And then Mikael?

謝謝。然後是米凱爾？

Yes, I think you asked about how could a new oral GLP 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 class on obesity in body weight, oral agents in general are preferred.

是的，我想您問的是如何將一種新的肥胖症口服 GLP 定位為具有最大吸引力，並以 danu 為例，當然，這取決於我們對數據的興奮程度。顯然，由於肥胖症和伴有超重的 2 型糖尿病的治療越來越多地從內分泌科醫生和代謝科醫生轉向初級保健，特別是該類藥物對體重肥胖有顯著效果，因此口服藥物通常更受青睞。

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 opinion leaders in the field that the patients regain 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，像新配方的潛在達諾利隆 (danuglipron) 這樣每天服用一次的藥物將會發揮有趣的作用。我認為該領域的意見領袖們也越來越多地討論患者停止注射藥物後體重會反彈。一般來說，它們的可用性只能維持一年左右。因此，長期服用的口服藥物也能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，您完全正確，該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經使用的藥物合併使用，例如用於保護心臟等。所以我想這就是為什麼這個班的學生對毒品有這麼大的興趣。感謝您的提問。

Thank you. Next question, please.

謝謝。請回答下一個問題。

Next, we have Tim Anderson with Wolfe Research.

接下來是 Wolfe Research 的 Tim Anderson。

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.

我有幾個問題。關於 danuglipron，早期資料集顯示出 QTC 訊號。您是否認為那隻是一條不會在後續數據中顯示的煙幕彈？對我來說，當我只考慮藥物類別並看到 QTC 訊號時，它似乎經常在以後的資料集中持續存在。

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.

第二個問題是關於 mRNA 流感。您提到安全性與獲得許可的疫苗相同。這是否意味著耐受性也是如此？我通常認為安全性和耐受性在技術上是彼此不同的。

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

非常好。非常感謝您的提問。米凱爾，這兩個問題都是問你的。 QTC 用於 danu，然後是耐受性...

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 名患者使用 danuglipron，它是一種非常安全的藥物，我們期待在年底之前獲得讀數和療效。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，耐受性才是我們真正關注的重點。且耐受性與現有的標準治療疫苗或輝瑞公司生產的其他 mRNA 疫苗相似，我們並沒有真正擔心安全性。因此，從耐受性和安全性來看，它看起來與我們先前版本的疫苗一樣。

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

謝謝你，邁克爾，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?

請問我有兩個問題。關於成本節約計劃，您一直在概述 2024 年的計劃。但如果我們看看您剛剛報告的季度中研發和 SI&A 支出的模式，我會發現研發支出的減少幅度大於 SI&A 的預期。我們應該怎麼解讀這些數字？從 SI&A 和 R&D 相對而言的成本降低幅度來看，有什麼可以解讀的嗎？

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 的一個問題。第一季的銷售業績穩健。您能否詳細說明其中有多少可能是由於庫存積壓與實際需求造成的？如果我們查看處方數據，從零售環境來看，市佔率約為 30%。這與您在更廣泛的市場中觀察到的情況相似嗎？這與您的預期相比如何？

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

讓我請大衛回答有關研發和 SI&A 費用的問題。然後安琪拉會拿走 Abrysvo。

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，我不會深入研究'23年的儲蓄分配與'24年的關係。顯然，我們今天已經啟動並運行了一個相當強大的計劃。我們正在積極開展這些計劃並開始實施這些計劃。隨著我們進入 2024 年，我們將為您和市場提供一些具體信息，說明如何在明年結束時考慮這些成本節約。

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。因此，我們對我們在 Abrysvo 上的表現感到非常滿意。它已經超出了我們的預期。您首先問這是否全部與庫存有關，我可以說不是。當然，由於這是一種新疫苗，因此一開始會有囤積效應，但我們也在密切追蹤疫苗接種率和接種情況。您會發現，其成長速度非常快。

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.

我們確實受益於此：該產品在疫苗接種季節真正到來之前就已獲得批准並投放市場。因此，它能夠借助流感疫苗接種的勢頭，你知道，9 月和 10 月流感疫苗接種率非常高。我們的共同給藥率約為70％。所以，我們在 Abrysvo 上看到的表現確實是由疫苗接種所推動的。

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.

對於您關於市場份額的評論，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的疫苗接種。但請不要忘記，並非所有疫苗接種都在那裡進行。我們也有非零售環境，例如醫療系統、醫生辦公室。這些也正在進行中，並且在那些特定的設置中，輝瑞實際上具有領先的偏好。儘管它們的比例較小，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 older adults, but also maternal, which, as you know, we just got the approval for.

最後，我認為，從勢頭的角度來看，我們預計事情將會繼續下去。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主要月份。從目前的情況來看，RSV 僅佔符合條件人口整個疫苗接種率的 5%。因此我認為，結論是，我們正處於這次發布的早期階段，並且表現比我們想像的要好。但我認為，我們將要去的地方是一個有巨大機會推動老年人和產婦接受該藥物的地方，正如你所知，我們剛剛獲得了這方面的批准。

Thank you. Next question, please.

謝謝。請回答下一個問題。

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 2 data, what should our expectation be around communicating plans for Phase 3, which I guess is just a quicker way of saying, what's a reasonable expectation for how quickly you could turn around the Phase 2 and start a Phase 3, and how much work Pfizer has already done on that front?

也許要回到口頭達努。當我們確實獲得第 2 階段的數據時，我們對傳達第 3 階段計劃的期望應該是什麼，我想這只是一種更快捷的說法，對於您能多快完成第 2 階段並開始第 3 階段的合理預期是什麼，以及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?

那麼也許剛從 ESMO 出來，基於 EV-302 的數據和回應，輝瑞是否會說這重申了他們的預期，或者代表了他們在最初宣布交易時的預期有所上調？

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 3, we hope that the data are good so that we can move into Phase 3. 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 danu 上，讓我接受這個，這樣我就可以節省一點 Mikael 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公開宣布。當然，當我們準備好進行第三階段研究時，我們希望數據良好，以便我們能夠進入第三階段。我希望我們能夠以加快的方式進行，因為在這場競爭分子的戰鬥中，速度至關重要。

But we will announce our plans for Phase 3. I know the interest is very high right now, but I won't be very prudent in not saying things without the data. The data are the key, and the data we haven't seen it yet. Now let me move to Chris so that we can discuss about the ESMO.

但我們會宣布第三階段的計劃。我知道現在大家的興趣很高，但如果沒有數據，我不會太謹慎地不說。數據是關鍵，而我們還沒有看到這些數據。現在讓我轉到克里斯那裡，以便我們可以討論 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 progression free 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301的提出。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，整體存活率和中位無惡化存活率幾乎翻了一番，使該族群的中位整體存活率目前接近 3 年。我們預計最終數字將高於這個數字，超過 1.5 個月。因此，這只是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的治療方案的標準。

Thank you very much. Next question, please.

非常感謝。請回答下一個問題。

Next we have Akash Tewari with Jefferies.

接下來是 Jefferies 的 Akash Tewari。

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 QD formulation?

這是 Ivy 為 Akash 主持的節目。我們的問題也是關於 danuglipron 的。那麼從每日一次的改良釋放版本開始，是否有可能對 QD 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，我想正如我們在電話會議上多次聽到的那樣，試驗在 10 月被標記為完成，我知道您還沒有看到頂線數據。那麼，現在我們是否正在等待這個較低的 4 週滴定隊列的數據？此外，如果存在任何臨床上顯著的嚴重問題，您是否會說您已經停止該計劃了？

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。在每日一次的重新配製的 danu 上，我們初步測試了標準的可膨脹芯技術，並證明它與 danu 配合良好。現在，為了能夠融入更複雜的技術，我們研究了矩陣技術，所有數據都表明這將是一個真正有趣的替代方案。

Because, as you know, in diabetes for oral 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 not? There was a -- okay.

因為如你所知，對於治療糖尿病和肥胖症的口服藥物，隨著時間的推移，你最終會結合使用不同的藥物來預防不同的下游效應。這就是這種新技術的美妙之處，未來你就有潛力去修復這些組合。我們在開發複雜配方方面確實是大師，我們將在 2024 年推出這款產品。我想還有第二部分。或不？有一個--好的。

Let's move to the next question, please. Thank you, Akash (sic), for your question.

請讓我們進入下一個問題。謝謝 Akash (原文如此) 的提問。

Next, we have Kerry Holford with Berenberg.

接下來是 Berenberg 公司的 Kerry Holford。

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 from PFE to GSK?

請問兩個關於疫苗的問題。談到 RSV，8 月份，葛蘭素史克對輝瑞提起訴訟，指控其侵犯專利。所以我想知道您是否可以談談接下來的步驟，或者您預計的時間表。我們是否應該認為這最終會導致 PFE 向 GSK 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 of 3, does that significantly reduce the commercial opportunity you had anticipated for the vaccine?

那麼關於 Penbraya，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如何？如果疫苗實際上僅用於 3 劑中的第 2 劑，這是否會大大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。道格，您能回答一下有關葛蘭素史克公司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責任感，現在說一方或另一方是否需要支付任何版稅或其他費用還為時過早，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，關於 Penbraya，您有什麼感想？

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。我們仍然對高峰銷售充滿信心。原因是現在，我們已經有第一套建議。但 ACIP 也告訴我們，明年當我們有更多的數據時，我們將有機會再次回來，那時我們將有機會查看四邊形的交付時間表——它們今天的交付時間表。我們將再次有機會了解 Penbraya 為該人群帶來的益處。因此，我覺得我們現在有機會開始為青少年接種疫苗，這真是太好了。我們將再次嘗試，這將使我們的銷售量達到高峰。

Thank you. Next question, please.

謝謝。請回答下一個問題。

Next, we have Andrew Baum with Citi.

接下來是花旗的安德魯·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?

幾個問題。您能否評論一下您在 RVT-3101（TL1A）中的股份，等待羅氏公司對該資產的授權批准？你會堅持下去嗎？或者說，這是否需要撤資？

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) or increased cell death?

第二個問題問克里斯。只要查看最近的 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 的結合時，您是否認為所看到的功效與對沖有關？或者您認為它是透過（聽不清楚）或增加細胞死亡而產生的真正協同作用？

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

阿米爾，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 2 program that required significant Phase 3 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 計劃的成果非常滿意。當我們創建 Televant 時，我們將此作為研發優先決策。需要提醒的是，這是一個第二階段的計劃，需要第三階段的大量投資。因此我們持有25%的股份。我們也擁有美國銷售的版稅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.

而且我們在沒有花費任何研發費用的情況下就做到了這一切。因此，羅氏提議收購 Televant 將為我們帶來約 17.5 億美元的稅前現金，這是我們所持有股份的折合金額。而我們仍然保留所有其他權利。因此，我們期待羅氏成為我們的合作夥伴。我們期待他們在推進 TL1A 臨床階段計畫方面進行投資，並從其成果中受益。

And Chris, about the synergies.

克里斯，談談協同效應。

Yes. Thanks, Andrew. That's a very good question. As you know, Seagen 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 topo 1 that will enter the clinic this year, next year, we don't know yet if the topo 1s are going to show similar types of immunogenicity as what appears to happen with the MMAE or auristatin-based payloads. So I think we're very confident that, that Seagen has both topa 1 as well auristatin-based payloads in case the topo 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，Seagen 率先推出了 MMAE 或基於他汀類的有效載荷。我們看到了 PD-1 與 ADCETRIS、與 Tivdak 以及最近與 Padcev 的結合的潛在協同作用。儘管 Seagen 確實擁有含有拓樸異構酶 1 的下一代 ADC，並將於今年或明年進入臨床，但我們還不知道拓樸異構酶 1 是否會表現出與 MMAE 或基於奧瑞他汀的有效載荷類似的免疫原性。所以我認為我們非常有信心，Seagen 同時擁有 topa 1 以及基於 auristatin 的有效載荷，以防 topo 1s 看起來是正確的類型...

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

非常感謝，克里斯。我們來討論最後一個問題。

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 etrasimod?

因此，我有一個關於 danu 的圖片，然後還有一個更大的圖片。因此需要澄清一下關於 danuglipron 的問題。米凱爾，最終目標是開發固定劑量組合，例如 SGLT2 或其他抗糖尿病藥物嗎？您在評論中提到了這一點。退一步來說，我們該如何看待您根據風險調整長期收入指導？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數據，例如 etrasimod 的批准？

Mikael, can you please take the question?

米凱爾，您能回答這個問題嗎？

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 and diabetes once-a-day danu. That's the near-term.

是的。我的意思是，近期目標是真正查看數據，阿爾伯特和我都這麼說過。當然，還有待審查，這是一個每天使用一次的 danu 來解決糖尿病肥胖症的選擇。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業務，這就是為什麼它受到如此大的興趣，其中包括固定劑量組合，這是注射劑所沒有的。但我們會讓其保持簡單和清晰。我們將審查數據並對每日一次的肥胖和糖尿病的可能性做出決定。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 the analyst expectations for these acquisitions, at the end of 2030 are very, very close to what we have right now.

非常感謝。關於您的問題，我們是否要改變已經宣布的 200 億美元或 250 億美元。首先，250 億美元是我們到 2030 年要獲得的。根據我們的估計，我們迄今已獲得——即將收購 Seagen——200 億美元。如果你看看分析師對這些收購的預期，你會發現 2030 年底的預期與我們現在的預期非常非常接近。

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 focusing our attention. 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。當您看到我們正在進行的內部專案發布管道（我們宣布其價值為 200 億美元）時，您會發現我們的預期和分析師的預期之間存在差距。這正是我們關注的重點。因此現在發布還處於早期階段。其中有些人做得比我們想像的要好，而有些人做得比我們想像的要差。如果我們意識到 200 億美元的總金額不再像我們想像的那樣，我們當然會進行更新。

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，你會發現我們的核心業務表現良好。我們將繼續努力。顯然，我們已經完成了很多發布，並且還有幾項發布等待我們完成。當我們考慮目前在腫瘤學領域的重點時，我們對 Seagen 可能為公司帶來的影響感到非常興奮。

And then importantly, I think we've rebaselined, 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，我認為我們已經重新調整了 COVID 特許經營權。想想今年下半年的利用率以及明年的周期，然後我們將退一步考慮一下，在考慮這家公司在進入24年及以後的總收入時，什麼是謹慎的。因此，我認為，當我們進入 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 PAXLOVID supply agreement.

好的。非常感謝。所以謝謝你。我只想說，如果今天的電話會議讓您只記住一件事，那就是我認為輝瑞的未來仍然光明。我們已經重新調整了對 COVID 的預期，現在我認為每個人都可以輕鬆地模擬我認為未來穩定的 COVID 收入，特別是最近修訂的 PAXLOVID 供應協議。

And of course, we are having a very strong performance of our new in-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，我們的新線內和新產品表現非常強勁，除 COVID 之外的產品組合本季成長了 10%。這使我們能夠在未來實現成長。現在我將結束本次通話。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.

謝謝各位，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。