使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good day, everyone, and welcome to Pfizer's second quarter 2026 earnings conference call. Today's call is being recorded.
各位好,歡迎參加輝瑞 2026 年第二季財報電話會議。今天的電話會議將進行錄音。
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.
此刻,我想把電話會議交給投資人關係長兼資深副總裁 Francesca DeMartino。女士,請開始。
Francesca DeMartino - Chief Investor Relations Officer and Senior Vice President
Francesca DeMartino - Chief Investor Relations Officer and Senior Vice President
Good morning, and welcome to Pfizer's earnings call. I'm Francesca 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.
各位早安,歡迎參加輝瑞的財報電話會議。我是投資人關係長 Francesca DeMartino。我代表輝瑞團隊,感謝各位加入。本次電話會議將透過 pfizer.com 提供音訊網路直播。
Earlier this morning, we released our results for the second quarter of 2026 via a press release that is available on our website at pfizer.com. I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Dave Denton, our CFO; Cecile Guegan, our Incoming Interim CFO; and Chris Boshoff, our Chief Scientific Officer. After their prepared remarks, we will open the call for questions. Members of our leadership team will be available for the Q&A session.
今天稍早,我們已透過新聞稿公布 2026 年第二季業績,新聞稿可於 pfizer.com 網站取得。我今天與會的有董事長兼執行長 Albert Bourla 博士、財務長 Dave Denton、即將上任的代理財務長 Cecile Guegan,以及首席科學長 Chris Boshoff。在他們的準備發言之後,我們將開放提問。我們的領導團隊成員將出席問答環節。
Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning and the disclosures in our SEC filings which are all available on the IR website on pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.
在開始之前,我想提醒各位,我們將發表前瞻性陳述,並討論若干非 GAAP 財務衡量指標。我鼓勵各位閱讀我們簡報投影片中的免責聲明、我們今天早上發布的新聞稿,以及我們向美國證券交易委員會(SEC)提交文件中的揭露內容;以上皆可於 pfizer.com 的投資人關係網站取得。本次電話會議中的前瞻性陳述存在重大風險與不確定性,僅反映電話會議原始日期之情況,我們不承擔更新或修訂任何陳述的義務。
With that, I will turn the call over to Albert.
接下來,我把電話會議交給 Albert。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Francesca. Good morning, everyone, and thank you for joining our call. We had another strong quarter of execution, driving continued strategic progress. Our revenues and adjusted diluted EPS in the second quarter once more exceeded expectations. This shows that our commercial teams are performing with excellence and precision and that we continue to operate with financial discipline.
謝謝你,Francesca。各位早安,感謝各位參加本次電話會議。我們又交出一個執行表現強勁的季度,持續推動策略進展。第二季的營收與調整後稀釋每股盈餘(EPS)再次超出預期。這顯示我們的商業團隊以卓越且精準的方式執行,同時我們也持續以財務紀律營運。
We also are building towards the future, advancing our R&D pipeline that provides multiple opportunities for success across our four therapeutic areas. Previously, we announced that Dave Denton would be leaving Pfizer soon for another opportunity. Since then, Dave has partnered closely with Cecile Guegan to prepare for this transition. Cecile is fully ready to serve as our interim CFO, including answering your financial questions during today's Q&A session. I want to thank Dave for his leadership, his dedication to Pfizer and all he has contributed to our company's success.
我們也在為未來奠基,推進研發產品線,在四大治療領域提供多重成功機會。先前我們宣布 Dave Denton 將於不久後離開輝瑞,前往另一個職涯機會。此後,Dave 與 Cecile Guegan 緊密合作,為此次交接做準備。Cecile 已完全準備好擔任代理財務長,包括在今天的問答環節回答各位的財務問題。我要感謝 Dave 的領導、他對輝瑞的投入,以及他為公司成功所做的一切貢獻。
With Cecile's leadership, I'm confident we are in very good hands. She has had a central role for years in shaping and driving Pfizer's financial and strategic direction. She is an expert in our industry and her field and knows our company well. She has worked closely with Dave and our leadership team in completing key transactions, developing our approach to capital allocation and driving efficiency and productivity improvements across our company.
在 Cecile 的領導下,我相信我們一切都會非常穩妥。多年來,她在塑造並推動輝瑞的財務與策略方向方面一直扮演核心角色。她是本產業與其專業領域的專家,也非常了解我們公司。她與 Dave 及我們的領導團隊密切合作,完成多項關鍵交易、制定資本配置方針,並推動全公司效率與生產力的提升。
Now, I'm confident in the years ahead because we have been purposeful in establishing a foundation marked by strong execution across our business, alignment among our leadership team and a clear strategy to guide our colleagues in working toward meaningful future growth and impact.
如今,我對未來幾年充滿信心,因為我們有意識地建立了堅實基礎:在各項業務上強力執行、領導團隊高度一致,並以清晰策略引導同仁共同努力,實現具意義的未來成長與影響力。
Let me go through our progress with our 2026 strategic priorities, starting with maximizing the value of key transactions. In the quarter, revenue for our acquired products grew 25% operationally when excluding the impact of certain one-time items in the same quarter a year ago. We view our Seagen, Metsera and Biohaven transactions as transformative opportunities for Pfizer. We are focused on execution and pleased with the progress we continue to make with each of them.
我來說明我們在 2026 年策略優先事項上的進展,首先是最大化關鍵交易的價值。本季在排除去年同季若干一次性項目的影響後,我們收購產品的營收以營運基礎計算成長 25%。我們將 Seagen、Metsera 與 Biohaven 的交易視為輝瑞的變革性機會。我們專注於執行,並對各項交易持續取得的進展感到滿意。
With the addition of Seagen, we gained an innovative platform, deep scientific expertise and a promising ADC pipeline central to our goal of growing our oncology. We also acquired a commercial portfolio that is delivering ahead of expectations. In the quarter, we drove strong revenue growth with a 21% year-over-year increase across the legacy Seagen portfolio in the US after excluding the one-time stocking benefit that we had in the second quarter of last year.
透過納入 Seagen,我們獲得了一個創新平台、深厚的科學專業,以及一條具前景的 ADC 產品線,這對我們擴大腫瘤業務的目標至關重要。我們也收購了一個商業化產品組合,其表現優於預期。本季在排除去年第二季一次性備貨帶來的效益後,美國市場的 Seagen 既有產品組合營收年增 21%,成長強勁。
With Metsera, we believe we are on a path towards unlocking a differentiated profile for patients with obesity and related conditions in a market expected to reach $150 billion. Data we shared recently at the American Diabetes Association Scientific Sessions reinforce why we are excited about berobenatide, which is an investigational ultra-long-acting GLP-1 receptor agonist with the potential to be the first monthly GLP-1 peptide approved for the treatment of obesity and related comorbidities. We are targeting a first approval in 2028. And this year alone, we expect to advance an extensive Phase 3 program that includes 10 studies for chronic weight management and obesity-related conditions.
就 Metsera 而言,我們相信正走在為肥胖及相關疾病患者解鎖差異化特徵的道路上;該市場預計將達到 1,500 億美元。我們近期在美國糖尿病協會(ADA)科學年會分享的數據,進一步強化了我們對 berobenatide 的期待;這是一款研發中的超長效 GLP-1 受體致效劑,具備成為首個獲准用於治療肥胖及相關共病的「每月一次」GLP-1 肽類藥物之潛力。我們的目標是在 2028 年取得首次核准。僅在今年,我們預期將推進一項龐大的第三期計畫,包含 10 項研究,涵蓋慢性體重管理與肥胖相關疾病。
Finally, the acquisition of Biohaven positioned our company as a leader in providing treatment options for migraine, a disease affecting an estimated 1.2 billion people worldwide. NURTEC delivered strong year-over-year growth again this quarter and continued to lead the oral CGRP class in total prescriptions.
最後,收購 Biohaven 使我們公司在提供偏頭痛治療選項方面躍升為領導者;偏頭痛估計影響全球約 12 億人。本季 NURTEC 再次實現強勁的年增成長,並持續在口服 CGRP 類別中以總處方量領先。
Looking ahead, we are working towards expansion opportunities that would further strengthen our impact for these patients. We have the Phase 3 trial underway for menstrual migraine, an area of high unmet patient need and another trial evaluating redosing for acute treatment of migraine. We also expect a pivotal trial start this year investigating NURTEC's use as a treatment for chronic migraine.
展望未來,我們正推進擴大適應症的機會,以進一步強化我們對這些患者的影響力。我們已啟動經期偏頭痛的第三期試驗;此領域患者未滿足需求很高,另有一項試驗正在評估用於偏頭痛急性治療的再次給藥。我們也預期今年將啟動一項關鍵性試驗,研究 NURTEC 作為慢性偏頭痛治療的用途。
Our pipeline progress through the first half of the year reflects our discipline in prioritizing programs where strong science, clinical execution and strategic investments can make the greatest impact for patients. Our R&D team already has been productive with our ambitious agenda, achieving critical milestones that included three regulatory approvals, six key data readouts and eight pivotal study starts so far.
我們在上半年取得的產品線進展,反映出我們在優先排序上的紀律:聚焦於能以強大科學、臨床執行與策略性投資,為患者帶來最大影響的計畫。我們的研發團隊在雄心勃勃的議程下已展現高產出,迄今達成多項關鍵里程碑,包括 3 項法規核准、6 項重要數據讀出,以及 8 項關鍵性研究啟動。
Oncology is a clear area of strength. In the past two years, we have initiated a dozen late-stage studies across our core tumor areas. We have unveiled data from 21 late-stage readouts and achieved six regulatory approvals.
腫瘤學是我們明確的優勢領域。在過去兩年中,我們已在核心腫瘤領域啟動 12 項後期研究。我們已公布 21 項後期讀出數據,並取得 6 項法規核准。
We also have clear line of sight to our aim of delivering a risk-adjusted high single-digit revenue CAGR from year-end 2028 through year-end 2033. This is supported by our bottoms-up analysis that included assessing our base of growing in-line products and 20 key potential new medicines and vaccines within our pipeline. We continue to prioritize investment in R&D, both on internal programs and selective business development with the potential to strengthen our position in key areas.
我們也清楚可見達成目標的路徑:自 2028 年底至 2033 年底,實現風險調整後的高個位數營收年複合成長率(CAGR)。此目標由我們自下而上的分析所支持,其中包括評估我們持續成長的既有上市產品基礎,以及產品線中 20 項關鍵潛在新藥與疫苗。我們持續優先投入研發,包含內部計畫與具選擇性的業務開發,以強化我們在關鍵領域的地位。
Financial discipline and cost management is allowing us to continue investing in growth. We now expect an additional $1 billion in savings from our ongoing cost realignment program, powered in part by rapid advancement of technology. Net cost savings from these programs are now expected to total $6.7 billion through 2029. We are also moving toward with the next phase of our manufacturing optimization program. And with additional savings, we now expect total net cost savings of approximately $3 billion from this program through 2029.
財務紀律與成本管理使我們得以持續投資成長。我們目前預期,正在進行的成本重整計畫將額外帶來 10 億美元的節省,其中部分動能來自科技的快速推進。這些計畫的淨成本節省目前預期至 2029 年將合計達 67 億美元。我們也正邁向製造優化計畫的下一階段。隨著額外節省的加入,我們目前預期該計畫至 2029 年的淨成本節省總額約為 30 億美元。
With our strong performance through the first half of the year and our ongoing productivity enhancement discipline, we remain confident in our business. Today, we are raising the midpoint of our revenue guidance for full year 2026 and reaffirming guidance for adjusted diluted earnings per share. And we remain committed to maintaining and over time, growing our dividend.
憑藉我們在今年上半年強勁的表現以及持續推動生產力提升的紀律,我們對業務仍然充滿信心。今天,我們上調2026全年營收指引的中點,並重申調整後稀釋每股盈餘指引。同時,我們仍致力於維持股利,並隨時間推進逐步提高股利。
We view AI as the structural transformation opportunity for driving substantial acceleration of our R&D pipeline, greater speed and productivity across our business and an improved competitive position for Pfizer. We are already seeing benefits from AI in reducing cost and expanding yields in manufacturing. It's helping to make our commercial field force more effective and sharpening our commercial marketing approach. Even greater opportunities are ahead as we apply AI to accelerate innovation in drug discovery and development. Our ambition is to build an AI-native R&D organization where every insight from target discovery through medical evidence continuously informs the next decision.
我們將AI視為一項結構性轉型機會,可大幅加速我們的研發管線、提升全公司營運速度與生產力,並強化輝瑞的競爭地位。我們已經看到AI在製造端降低成本並提高良率的效益。它也有助於提升我們商業外勤團隊的效能,並使我們的商業行銷策略更精準。當我們將AI應用於加速藥物發現與開發的創新時,前方還有更大的機會。我們的目標是打造一個AI原生的研發組織,讓從標的發現到醫學證據的每一項洞見,都能持續為下一個決策提供資訊。
In summary, I'm confident in how our business is positioned. We executed well and operated with continued financial discipline through the first half of 2026. With our performance in the second quarter, this is the ninth time we exceeded consensus expectations for revenues in the last 10 quarters, and we have beaten expectations for adjusted diluted EPS in all 10 of the 10 past quarters.
總結來說,我對我們業務的定位充滿信心。在2026年上半年,我們執行到位,並持續以財務紀律運營。憑藉第二季的表現,在過去10個季度中,我們有9次營收超出市場一致預期,且在過去10個季度中的每一季,我們的調整後稀釋每股盈餘(EPS)皆優於預期。
And with that, what a better slide to turn it over to Dave and Cecile.
接下來,沒有比這張投影片更適合把時間交給Dave和Cecile了。
David Denton - Executive Vice President, Chief Financial Officer
David Denton - Executive Vice President, Chief Financial Officer
Great. Thank you, Albert, and good morning, everyone. Leaving Pfizer was a difficult decision, but it's the right one for me personally. I'm deeply proud of what we've accomplished together, the team that we have built and the vision for the future of Pfizer. The results of this quarter show how well our company is executing and why we are confident in the strategy for returning to growth post 2028. We anticipated that a substantial portion of today's call will focus on our outlook for the remainder of this year as well as our strategy for creating long-term value for both patients and shareholders.
很好。謝謝你,Albert,各位早安。離開輝瑞是一個艱難的決定,但就我個人而言,這是正確的選擇。我對我們共同完成的成果、我們打造的團隊,以及輝瑞未來的願景深感自豪。本季的結果顯示公司執行力之強,也說明了為何我們對2028年後重返成長的策略充滿信心。我們預期今天電話會議的相當一部分將聚焦於今年剩餘期間的展望,以及我們為病患與股東創造長期價值的策略。
So with that in mind, we determined it would be best for you to hear directly from Cecile. I've worked closely with Cecile, seeing firsthand how she leads effectively with her deep financial knowledge, her expertise and the respect that she has earned from the entire organization. I leave knowing that Cecile will guide Pfizer's financial and growth strategy with both rigor, discipline and continuity.
基於此,我們認為最好讓各位直接聽Cecile說明。我與Cecile密切合作,親眼見證她憑藉深厚的財務知識、專業能力,以及她在整個組織中贏得的尊重,展現出卓越的領導力。我離開時很放心,因為我知道Cecile將以嚴謹、紀律與延續性,引領輝瑞的財務與成長策略。
And with that, I'm pleased to turn it over to Cecile.
接下來,我很高興把時間交給Cecile。
Cecile Guegan - Incoming Interim Chief Financial Officer
Cecile Guegan - Incoming Interim Chief Financial Officer
Thank you, Albert and Dave, and good morning. Before I discuss second quarter results, I want to underscore Albert's comment. I believe Pfizer is well positioned to return to growth from 2029 onward and create meaningful value for shareholders. We will continue to execute a disciplined approach to capital allocation, making targeted investment today to drive revenue growth later in the decade and beyond. We intend to do this while maintaining and over the long term, growing the dividend.
謝謝你,Albert和Dave,各位早安。在我討論第二季業績之前,我想強調Albert的評論。我相信輝瑞已做好充分準備,從2029年起重返成長,並為股東創造具意義的價值。我們將持續以紀律性的資本配置方式執行,於今日進行有針對性的投資,以推動本十年後期及更長期的營收成長。我們也將在此同時維持股利,並在長期逐步提高股利。
Our business is performing well. Commercial execution is driving strong results, including 18% operational revenue growth in our launched and acquired products this quarter. We continue to strengthen and advance our pipeline. With the continued growth of our launched and acquired products, we are laying the groundwork for high single-digit revenue growth towards the end of the decade. Our second quarter adjusted earnings performance reflects disciplined execution across our strategic priorities and continued progress towards building the foundation for durable long-term value creation.
我們的業務表現良好。商業執行帶動強勁成果,包括本季已上市與併購產品的營收按營運口徑成長18%。我們持續強化並推進研發管線。隨著已上市與併購產品持續成長,我們正在為本十年末期達成高個位數營收成長奠定基礎。第二季調整後盈餘表現反映我們在各項策略優先事項上的紀律執行,以及在建立可持續長期價值創造基礎方面的持續進展。
I will review our results from the quarter, productivity enhancement initiatives, capital allocation priorities and full year guidance. We are raising the midpoint of our revenue guidance range despite lower-than-expected COVID revenues. We are also reaffirming adjusted diluted EPS guidance, which absorbs an approximately $0.10 impact related to the Innovent Biologics transaction that closed in the third quarter of 2026.
我將回顧本季業績、生產力提升計畫、資本配置優先事項以及全年指引。儘管COVID營收低於預期,我們仍上調營收指引區間的中點。我們也重申調整後稀釋每股盈餘(EPS)指引,其中已吸收與Innovent Biologics交易相關、約0.10美元的影響;該交易於2026年第三季完成交割。
We delivered revenue growth in the quarter through disciplined execution across key brands in the US and select international markets. Second quarter 2026 revenue were $15 billion, ahead of our expectations and representing a year-over-year operational increase of 1%. Excluding COVID products, the underlying business delivered 5% operational revenue growth.
我們透過在美國及部分國際市場的關鍵品牌上採取紀律性執行,實現本季營收成長。2026年第二季營收為150億美元,高於我們預期,按年計算按營運口徑增加1%。若排除COVID產品,基礎業務按營運口徑實現5%的營收成長。
Progress leveraging data and scaling AI across the company supported our field force in driving access and increasing uptake for new launches. Our commercial performance has also helped mitigate the impact of currently low COVID infection levels.
在公司內部推進數據運用並擴大AI規模的進展,支持我們的外勤團隊推動可及性並提升新產品上市的採用率。我們的商業表現也有助於緩解目前COVID感染水準偏低所帶來的影響。
On the bottom line, second quarter adjusted diluted EPS was $0.77, also exceeding our expectations. This outperformance reflects continued cost discipline and productivity across the organization, while we still advance several Phase 3 study starts across our pipeline. Our results this quarter demonstrate the effectiveness of our commercial strategy.
在獲利方面,第二季調整後稀釋每股盈餘為0.77美元,同樣超出我們預期。這項優於預期的表現反映出全組織持續的成本紀律與生產力提升,同時我們仍在研發管線中推進多項第三期研究的啟動。本季結果證明我們商業策略的有效性。
We saw solid contribution across the portfolio, primarily driven by Eliquis, Padcev, the Vyndaqel family and Lorbrena, each reflecting focused execution in key therapeutic areas. We also expect post-2028 cash flow to benefit from the previously announced Vyndamax patent settlement.
我們看到產品組合各部分均有穩健貢獻,主要由Eliquis、Padcev、Vyndaqel系列以及Lorbrena所帶動;這些產品皆反映出我們在關鍵治療領域的聚焦執行。我們也預期,2028年後的現金流將受益於先前公布的Vyndamax專利和解。
Across international and US markets, our commercial team are focused on identifying patients, enabling access and supporting duration of therapy based on clinical data. This has helped us maintain leadership position across oncology and vaccines and unlock new opportunities.
在國際與美國市場,我們的商業團隊專注於辨識病患、促進可及性,並依據臨床數據支持治療持續時間。這有助於我們在腫瘤與疫苗領域維持領先地位,並開啟新的機會。
We continue to drive value in key in-line products approaching -- ahead of approaching LOEs, while our launched and acquired product delivered $3.2 billion in revenues and grew 18% operationally in the quarter. Of note, this growth rate was tempered by one-time items recorded in the second quarter of 2025, mostly impacting the legacy Seagen in-line portfolio. Excluding this impact, the growth rate was 27%. We continue to invest behind in-line brands and launched and acquired products to support their growth trajectory and help offset incoming LOE headwinds over the next several years.
在接近專利到期(LOE)之前,我們持續在關鍵既有產品中推動價值;同時,我們的已上市與併購產品本季營收達32億美元,按營運口徑成長18%。值得注意的是,該成長率受到2025年第二季入帳的一次性項目影響而有所抑制,主要影響傳統Seagen既有產品組合。若排除此影響,成長率為27%。我們持續加大對既有品牌以及已上市與併購產品的投資,以支持其成長軌跡,並協助抵銷未來數年即將到來的LOE逆風。
Financial discipline and strong cost management across our manufacturing footprint remain top priorities. Adjusted gross margin for the second quarter was 76%, primarily reflecting product mix and ongoing cost control measures. We continue to expect $700 million in savings from Phase 1 of our manufacturing optimization program this year with $175 million realized in Q2. Total adjusted operating expenses were $6.1 billion for the second quarter of 2026, an increase of 4% operationally versus second quarter last year.
在整體製造版圖中維持財務紀律與強勁的成本管理,仍是首要任務。第二季調整後毛利率為76%,主要反映產品組合以及持續的成本控制措施。我們仍預期今年可從製造優化計畫第一階段取得7億美元節省,其中第二季已實現1.75億美元。2026年第二季總調整後營業費用為61億美元,較去年第二季按營運口徑增加4%。
Looking at the components. Adjusted SG&A expenses decreased 3% operationally, primarily reflecting lower spending in corporate enabling function. Adjusted R&D expenses increased 12% operationally, primarily driven by an increase in spending in certain oncology and obesity product candidates. Second quarter 2026 adjusted operating margin was strong at 35%, reflecting effective cost management, strong non-COVID revenue performance and higher R&D investment in the quarter.
來看各項組成。調整後銷售、一般及行政(SG&A)費用按營運口徑下降3%,主要反映公司支援職能的支出降低。調整後研發(R&D)費用按營運口徑上升12%,主要由部分腫瘤與肥胖產品候選藥物的支出增加所帶動。2026年第二季調整後營業利益率維持強勁,達35%,反映有效的成本管理、非COVID營收的強勁表現,以及本季較高的研發投資。
Turning to the bottom line. Q2 reported loss per share was negative $0.04, and our adjusted diluted EPS was positive $0.77, which benefited from our strong non-COVID revenues and efficient operating structure. Our second quarter GAAP results reflect the impact of the recent Phase 3 readout for SV in second-line plus non-small cell lung cancer and to a lesser extent, the removal of revenue projection for Oxbryta following recent discussion with the FDA.
接著談到最終損益。第二季每股報告虧損為負0.04美元,而我們調整後稀釋每股盈餘(EPS)為正0.77美元,受惠於我們強勁的非COVID營收與高效率的營運架構。我們第二季GAAP結果反映了近期SV在二線加非小細胞肺癌的第3期讀出之影響,並在較小程度上反映了在近期與FDA討論後,移除Oxbryta營收預測的影響。
The updated forecast resulted in $4.3 billion in non-cash intangible asset impairments recorded in the quarter. For SV, we continue to forecast significant risk-adjusted revenue in other non-small cell lung cancer indications, subject to technical and regulatory success. So far, Seagen revenue performance has exceeded our initial expectation, and we aim to continue delivering above initial expectation in the long term. We remain disciplined in operating expense management and focused on long-term margin improvement.
更新後的預測導致本季認列43億美元的非現金無形資產減損。就SV而言,我們仍預測其在其他非小細胞肺癌適應症中可帶來顯著的風險調整後營收,惟須視技術與法規核准成功而定。迄今為止,Seagen的營收表現已超出我們的初始預期,我們的目標是在長期持續交出高於初始預期的表現。我們在營運費用管理上維持紀律,並聚焦於長期利潤率改善。
We have made meaningful progress on our productivity enhancement initiative and remain on track to deliver most of the anticipated $7.2 billion in total net cost savings by the end of 2026. Building on that momentum, today, we announced the expansion of our ongoing cost improvement programs, which are expected to generate approximately $2.5 billion in additional net cost savings from 2027 through 2029.
我們在生產力提升計畫上已取得實質進展,並仍按計畫在2026年底前實現預期總計72億美元淨成本節省中的大部分。在此動能基礎上,我們今日宣布擴大現行的成本改善方案,預期將在2027年至2029年期間額外帶來約25億美元的淨成本節省。
We now expect $1 billion of additional net cost savings from our productivity enhancement from technology and simplification efforts designed to further reduce SI&A cost. Separately, the next phase of our multi-year manufacturing optimization program is designed to reduce cost of goods sold and deliver approximately $1.5 billion in additional net cost savings, and we expect to begin realizing a portion of this saving in 2027. This next phase focuses on network structure changes, product portfolio enhancement and additional operational efficiency. We now expect total net cost savings from this program of approximately $3 billion through 2029.
我們目前預期,透過技術與簡化措施的生產力提升,將額外帶來10億美元的淨成本節省,這些措施旨在進一步降低SI&A成本。另外,我們多年期製造優化計畫的下一階段旨在降低銷貨成本,並帶來約15億美元的額外淨成本節省;我們預期將於2027年開始實現其中一部分節省。此下一階段聚焦於網路結構調整、產品組合強化及進一步的營運效率提升。我們目前預期,該計畫至2029年的總淨成本節省約為30億美元。
In summary, we now expect approximately $9.7 billion in total net savings from this program through 2029. These initiatives are expected to enhance operating efficiency, support continued operating margin expansion and strengthen our ability to invest in innovation and future growth opportunities.
總結而言,我們目前預期該計畫至2029年可帶來約97億美元的總淨節省。這些措施預期將提升營運效率、支持營業利潤率持續擴張,並強化我們投資創新與未來成長機會的能力。
Let me now turn to capital allocation. Our strategy is designed to enhance long-term shareholder value while preserving flexibility. It includes reinvesting in the business at appropriate returns, maintaining and over time growing our dividend, and preserving optionality for future value-enhancing actions, including share repurchases.
接下來我談資本配置。我們的策略旨在提升長期股東價值,同時保有彈性。其內容包括以適當報酬再投資於業務、維持並隨時間推進提高股利,以及保留未來可提升價值行動的選擇權,包括庫藏股回購。
In the first half of 2026, we invested $5.5 billion in internal and external R&D and returned $4.9 billion to shareholders via our quarterly dividend. The Innovent Biologics deal closed in July, resulting in an initial $650 million upfront payment to be recorded as acquired in-process R&D expense in the third quarter. Following this transaction, our BD capacity is approximately $6 billion. Second quarter 2026 operating cash flow was $3.45 billion and leverage ended the quarter at 2.7 times.
2026年上半年,我們在內部與外部研發(R&D)投資55億美元,並透過季度股利向股東回饋49億美元。Innovent Biologics交易已於7月完成,產生6.5億美元的初始預付款,將於第三季以取得之在研研發(IPR&D)費用入帳。完成此交易後,我們的BD(業務開發)資金量能約為60億美元。2026年第二季營運現金流為34.5億美元,季末槓桿倍數為2.7倍。
Given the LOE impact over the next few years, we expect leverage to remain around current level or modestly higher through this transition period. Earlier in the quarter, we made our final TCJA repatriation tax payment of approximately $2.6 billion and closed on our exit of ViiV, providing approximately $1.65 billion in net cash proceeds.
考量未來幾年的LOE(專利到期)影響,我們預期在此過渡期間槓桿將維持在目前水準附近或略高。本季稍早,我們完成約26億美元的TCJA匯回稅款最終支付,並完成退出ViiV交易,帶來約16.5億美元的淨現金收入。
Based on our performance to date and continued execution, we are raising our full year 2026 guidance by $500 million at the midpoint to a range of $60.5 billion to $62.5 billion from $59.5 billion to $60.5 billion. Our updated revenue guidance reflects strong non-COVID product performance and revised revenue expectation of approximately $4 billion, down from $5 billion for COVID-19 revenues.
基於迄今表現與持續執行,我們將2026全年指引中點上調5億美元,從595億至605億美元上調至605億至625億美元。我們更新後的營收指引反映非COVID產品的強勁表現,以及COVID-19營收預期修正為約40億美元(低於原先的50億美元)。
We are reaffirming all other components of guidance, including adjusted diluted EPS guidance of $2.80 to $3. This EPS range now absorbs an unfavorable impact of approximately $0.10 related to the $650 million acquired in-process R&D charge from the Innovent Biologics transaction. This outlook reflects year-to-date performance, confidence in our business, progress with ongoing cost improvement initiatives, our expectation of adjusted gross margin in the mid-70s range and continued investment to support growth by the end of the decade.
我們重申指引的其他所有組成項目,包括調整後稀釋EPS指引為2.80至3.00美元。此EPS區間現已吸收約0.10美元的不利影響,該影響與Innovent Biologics交易所產生的6.5億美元取得之在研研發(IPR&D)費用相關。此展望反映年初至今表現、我們對業務的信心、持續成本改善措施的進展、我們對調整後毛利率落在70%中段區間的預期,以及為支持本十年末成長而持續投資。
Low COVID-19 incidence could continue to limit Paxlovid utilization. Our plan also assumes that the majority of COMIRNATY sales will occur toward year-end, consistent with the vaccination season. And as always, we will continue to monitor currency fluctuation as the year progresses.
COVID-19發生率偏低可能持續限制Paxlovid的使用量。我們的計畫亦假設COMIRNATY的大部分銷售將在年底前後發生,與疫苗接種季節一致。並且一如既往,我們將隨著年度推進持續監測匯率波動。
Now, I will wrap up with a few key points. Over the next several years, we will continue to position Pfizer for high single-digit revenue growth towards the end of the decade. We will invest in our business with focus and discipline, supporting continued progress with our R&D pipeline and driving commercial impact with our launched and acquired product.
現在我用幾個重點作結。在未來幾年,我們將持續為輝瑞(Pfizer)布局,於本十年末實現高個位數的營收成長。我們將以聚焦與紀律投資於業務,支持研發管線的持續進展,並透過已上市與併購取得的產品推動商業影響力。
We remain committed to disciplined capital allocation with a continued focus on maintaining and over the long term, growing our dividend while preserving balance sheet strength and flexibility. We will continue to operate with rigor and strategic focus, executing with discipline today while building a strong foundation for the future. I look forward to working with Albert and the entire executive leadership team as we help patients around the world and position Pfizer for long-term growth and shareholder value creation.
我們仍致力於具紀律的資本配置,持續聚焦於維持股利並在長期逐步提高股利,同時維持資產負債表的強健與彈性。我們將持續以嚴謹與策略聚焦的方式營運,今日以紀律執行,同時為未來建立堅實基礎。我期待與Albert及整個高階管理團隊合作,協助全球病患,並使輝瑞在長期成長與股東價值創造上取得有利定位。
With that, let me turn over to Chris.
接下來,我把時間交給Chris。
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Thanks, Cecile. I will now provide additional color on the past quarter. Starting with the recent Phase 3 readout for Litfulo in nonsegmental vitiligo, a condition affecting more than 1 million adults in the US alone. In the TRANQUILLO program, both the 50- and 100-milligram doses of Litfulo delivered significant clinically meaningful improvements over placebo on co-primary endpoints for the facial and Total Body Vitiligo Area Scoring Index or VASI. Specifically, the program measured the percentage of patients that achieved a certain percent improvement from baseline, 75% for facial VASI and 50% for total VASI at week 52.
謝謝你,Cecile。我現在將就上一季提供更多補充說明。先從Litfulo在非節段型白斑(nonsegmental vitiligo)的近期第3期讀出談起;此疾病僅在美國就影響超過100萬名成人。在TRANQUILLO計畫中,Litfulo的50毫克與100毫克劑量在共同主要終點(臉部與全身白斑面積評分指數,即VASI)上,相較安慰劑皆帶來顯著且具臨床意義的改善。具體而言,該計畫衡量在第52週時,達到相對基線一定比例改善的患者比例:臉部VASI改善75%,以及全身VASI改善50%。
On the right, data for Litfulo, an internally discovered molecule with unique mechanism of action targeting TEC family kinases and JAK3, alongside results from recent pivotal trials of oral JAK1 selective inhibitors. These data show placebo-adjusted percentages of participants achieving facial VASI75. At the 100-milligram dose, Litfulo induced a placebo-adjusted response rate of 19.5% at week 52.
右側為Litfulo的數據;Litfulo為內部發現的分子,具獨特作用機轉,靶向TEC家族激酶與JAK3,並與近期口服JAK1選擇性抑制劑的關鍵性試驗結果並列。這些數據顯示參與者達到臉部VASI75的、經安慰劑調整後的百分比。在100毫克劑量下,Litfulo於第52週誘發的安慰劑調整後反應率為19.5%。
While cross-trial comparisons cannot support definitive conclusions, we're encouraged when viewing these facial VASI results alongside external comparator data. Management of vitiligo requires continued and durable treatment, which is why we are particularly encouraged by emerging data from our extension study demonstrating a sustained treatment effect with continued dosing at 100 milligrams after two years.
雖然跨試驗比較無法支持明確結論,但當我們將這些臉部VASI結果與外部對照數據一併觀察時,仍感到鼓舞。白斑的管理需要持續且具持久性的治療,因此我們對延伸研究的新興數據特別感到振奮:在兩年後持續以100毫克給藥,仍顯示治療效果得以維持。
Moving to oncology. I'll start with Padcev, the transformative bladder cancer medicine from our Seagen transaction. Last month, the FDA expanded the approved indication of Padcev plus pembrolizumab to muscle invasive bladder cancer regardless of cisplatin eligibility. The expansion was based on Phase 3 results showing a 35% reduction in the risk of death versus standard of care.
接著談腫瘤領域。我先從 Padcev 談起,這是我們透過 Seagen 交易取得、具變革性的膀胱癌藥物。上個月,FDA 擴大核准 Padcev 合併 pembrolizumab 的適應症至肌肉侵襲性膀胱癌,不論是否符合使用 cisplatin 的資格。此次擴大核准係基於第 3 期結果,顯示相較於標準治療可將死亡風險降低 35%。
Together with prior data showing unprecedented survival benefits in the cisplatin-ineligible muscle invasive and locally advanced or metastatic settings, these results establish Padcev as a potential practice-changing medicine for more than 42,000 patients in the US alone. This quarter, we also initiated a Phase 3 trial in the bladder-sparing muscle invasive bladder cancer setting, aiming to extend Padcev transformative benefits even further and to offer an option for patients seeking to avoid cystectomy.
結合先前數據在不適用 cisplatin 的肌肉侵襲性,以及局部晚期或轉移性情境中展現前所未有的存活效益,這些結果確立 Padcev 有望成為改變臨床實務的藥物,僅在美國就可惠及超過 42,000 名患者。本季我們也在保留膀胱的肌肉侵襲性膀胱癌情境啟動一項第 3 期試驗,目標是進一步擴大 Padcev 的變革性效益,並為希望避免膀胱切除術(cystectomy)的患者提供一個選項。
Combined with our leading capabilities in small molecules and protein engineering, we are now advancing the next wave of potential ADC breakthroughs in the clinic, leveraging innovative linkers, payloads and targets. Two I will highlight. GPS, which includes an auristatin S payload designed for improved tolerability and 3028 from Innovent, a bispecific dual payload ADC integrating multiple clinically validated approaches. With these and other programs, we aim to cement Pfizer as a leading developer of ADCs, maximizing the value from recent transactions.
結合我們在小分子與蛋白質工程方面的領先能力,我們正推進下一波具潛力的 ADC 臨床突破,運用創新連接子(linkers)、載荷(payloads)與標的。我將重點提兩項。GPS(包含 auristatin S 載荷,旨在提升耐受性)以及來自 Innovent 的 3028,這是一款雙特異性、雙載荷 ADC,整合多項已在臨床驗證的方法。透過這些與其他計畫,我們的目標是鞏固 Pfizer 作為 ADC 領先開發者的地位,並最大化近期交易的價值。
In June, we announced the primary overall survival endpoint was not met in the intention to treat population non-small cell, non-squamous non-small cell lung cancer. Though a disappointing outcome, we were encouraged that the subgroup of patients who received only one prior line of therapy showed a median survival benefit of 2.5 months, 13.6 with SV versus 11.1 months with docetaxel. This suggests a survival benefit that is meaningful for patients.
6 月,我們宣布在意向治療(intention to treat)族群中,於非小細胞、非鱗狀非小細胞肺癌的主要整體存活期終點未達成。儘管結果令人失望,我們仍受到鼓舞:僅接受過一線治療的患者亞組顯示中位存活期增加 2.5 個月,SV 為 13.6 個月,相較之下 docetaxel 為 11.1 個月。這顯示對患者而言具有意義的存活效益。
For context, standard of care ramucirumab plus docetaxel was approved based on a survival benefit of 1.4 months in its pivotal second-line trial, though no definitive conclusions can be drawn across studies. Together with updated Phase 1 data we are sharing today, these results reinforce that SV has the potential to deliver meaningful activity in earlier lines of lung cancer.
作為背景,標準治療 ramucirumab 合併 docetaxel 的核准,是基於其關鍵性二線試驗中 1.4 個月的存活效益,惟跨研究比較無法得出明確結論。結合我們今天分享的更新第 1 期數據,這些結果強化 SV 在肺癌較早治療線別中具有提供具意義療效的潛力。
On the right are updated Phase 1 data of SV plus pembrolizumab in first-line non-small cell lung cancer with high PD-L1 expression, the same regimen and indication as our ongoing Phase 3 trial. These data show robust activity with an unconfirmed objective response rate of about 82%, including a complete response.
右側為 SV 合併 pembrolizumab 於第一線高 PD-L1 表現之非小細胞肺癌的更新第 1 期數據,該療法組合與適應症與我們正在進行的第 3 期試驗相同。這些數據顯示強勁活性,未確認的客觀反應率約 82%,其中包含完全反應。
This compares favorably to historical anti-PD-1 monotherapy. These data align with the ability of vedotin ADCs to induce immunogenic cell death and thereby potentially synergize with anti-PD-1 agents such as pembrolizumab. We've seen meaningful activity when combining vedotin with immune checkpoint blockers in our Padcev, Tivdak and Adcetris programs, and we aim to extend this finding in SV's ongoing Phase 3 trial.
相較於歷史上的抗 PD-1 單藥治療,表現更具優勢。這些數據與 vedotin 類 ADC 可誘發免疫原性細胞死亡、因而可能與 pembrolizumab 等抗 PD-1 藥物產生協同作用的機制一致。在 Padcev、Tivdak 與 Adcetris 計畫中,我們已觀察到 vedotin 與免疫檢查點抑制劑合併時具有具意義的活性;我們也希望在 SV 正在進行的第 3 期試驗中延伸此發現。
Moving to 4404, our PD-1 VEGF bispecific antibody that has the potential to be a next-generation backbone therapy. Of note, the ongoing Phase 1 dose escalation study of 4404 in combination with SV is showing early and encouraging response rates. Since in-licensing from 3SBio about a year ago, we started nine trials, including two Phase 3 studies. We have expanded the program's global reach with approximately 230 patients dosed outside of China to date and are encouraged that the safety profile has remained consistent. Our goal is to develop 4404 as a potential best-in-class foundational therapy across multiple tumor types.
接著談 4404,我們的 PD-1/VEGF 雙特異性抗體,具備成為下一代基礎骨幹治療(backbone therapy)的潛力。值得注意的是,4404 與 SV 合併的第 1 期劑量遞增研究正在顯示早期且令人鼓舞的反應率。自約一年前自 3SBio 引進授權以來,我們已啟動 9 項試驗,其中包含 2 項第 3 期研究。我們已擴大全球布局,截至目前在中國以外已為約 230 名患者給藥,且安全性概況仍維持一致,令人鼓舞。我們的目標是將 4404 開發為可跨多種腫瘤類型、具潛力的同類最佳(best-in-class)基礎治療。
Our ambitions with 4404 supported by its differentiated profile recently presented at AACR, including in vitro data showing soluble VEGF-A affinity that is 30 to 60-fold higher than the PD-1 VEGF bispecific ivonescimab and the VEGF monoclonal anti-bevacizumab.
我們對 4404 的企圖心,來自其在 AACR 近期發表的差異化特徵所支持;其中包含體外數據顯示,其對可溶性 VEGF-A 的親和力較 PD-1/VEGF 雙特異性抗體 ivonescimab 以及 VEGF 單株抗體 bevacizumab 高出 30 至 60 倍。
Our Phase 2 data remain encouraging at a selected pivotal dose in first-line PD-L1 positive non-small cell lung cancer, 4404 monotherapy generated a confirmed response rate of about 68% and median progression-free survival of about 12.4 months. As you can see on the right, these data compare favorably with ivonescimab's Phase 3 results in this population, though cross-trial comparisons preclude definitive conclusions.
我們在第一線 PD-L1 陽性非小細胞肺癌、選定的關鍵性劑量下之第 2 期數據仍令人鼓舞:4404 單藥治療產生約 68% 的已確認反應率,且中位無惡化存活期約 12.4 個月。如右所示,這些數據與 ivonescimab 在該族群的第 3 期結果相比具優勢,但跨試驗比較使我們無法得出明確結論。
Moving next to mevrometostat, our potential first-in-class internally discovered EZH2 inhibitor. EZH2 is the core catalytic subunit of the polycomb repressor complex 2 PRC2. Mevrometostat is currently in Phase 3 development and the next potential breakthrough in our prostate franchise, including XTANDI and TALZENNA. Mevrometostat targets the underlying epigenetic mechanisms that drive resistance to andro receptor pathway inhibitors such as XTANDI.
接著是 mevrometostat,我們內部發現、具潛力的同類首創(first-in-class)EZH2 抑制劑。EZH2 是多梳抑制複合體 2(PRC2)的核心催化亞基。Mevrometostat 目前正進入第 3 期開發,並可能成為我們前列腺癌產品線(包含 XTANDI 與 TALZENNA)的下一項潛在突破。Mevrometostat 鎖定驅動對雄激素受體路徑抑制劑(如 XTANDI)產生抗藥性的根本表觀遺傳機制。
We are encouraged by the randomized Phase 1 data in post-abiraterone hormone-resistant prostate cancer, showing radiographic progression-free survival more than doubling with mevrometostat plus XTANDI versus XTANDI alone. This translated to a 49% reduction in risk of disease progression or death. We are taking a comprehensive approach with Mevrometostat's development with three pivotal studies underway, including MEVPRO-1, evaluating Mevrometostat plus XTANDI versus either XTANDI or docetaxel in post-abiraterone metastatic hormone-resistant prostate cancer.
我們對於在 abiraterone 後之荷爾蒙抗性前列腺癌的隨機第 1 期數據感到鼓舞:mevrometostat 合併 XTANDI 相較於單用 XTANDI,影像學無惡化存活期增加逾一倍。這相當於疾病惡化或死亡風險降低 49%。我們以全面性的方式推進 Mevrometostat 的開發,目前有三項關鍵性研究進行中,其中包括 MEVPRO-1,評估在 abiraterone 後之轉移性荷爾蒙抗性前列腺癌中,Mevrometostat 合併 XTANDI 相較於 XTANDI 或 docetaxel。
Each of these studies is event-driven with the first readout expected for MEVPRO-1 in the fourth quarter based on the current event rate. In MEVPRO-1, our goal is to delay resistance to XTANDI, which has historically delivered radiographic progression-free survival of about five to eight months in similar settings.
上述每項研究皆為事件驅動(event-driven),依目前事件發生率推估,MEVPRO-1 的首次讀出預計在第四季。在 MEVPRO-1 中,我們的目標是延緩對 XTANDI 的抗藥性;在類似情境下,XTANDI 過去的影像學無惡化存活期約為 5 至 8 個月。
Obesity is a core focus area for our R&D organization. In June, we presented Phase 2b data supporting berobenatide's potential as a first-in-class monthly GLP-1 receptor agonist peptide and foundational metabolic medicine. Shown here are Phase 2b ADA data on monthly berobenatide at 4.8 milligrams, which is our medium Phase 3 dose. At this dose, we achieved placebo-corrected weight loss of up to 12.3% in our VESPER-3 trial.
肥胖是我們研發組織的核心聚焦領域。6 月,我們發表第 2b 期數據,支持 berobenatide 作為同類首創、每月一次 GLP-1 受體致效劑胜肽與基礎代謝藥物的潛力。此處展示的是每月一次 berobenatide 4.8 毫克的第 2b 期 ADA 數據,這是我們第 3 期的中劑量。在此劑量下,我們在 VESPER-3 試驗中達到經安慰劑校正後最高 12.3% 的體重下降。
Though cross-trial comparisons cannot support definitive conclusions, it is encouraging that berobenatide achieved week 28 efficacy that was similar to tirzepatide's medium dose of 10 milligrams in the SURMOUNT-1 study and potentially better than semaglutide's medium approved dose of 2.4 milligrams in STEP 1.
儘管跨試驗比較無法支持明確結論,但令人鼓舞的是,berobenatide 在第 28 週的療效與 SURMOUNT-1 研究中 tirzepatide 的 10 毫克中劑量相近,且可能優於 STEP 1 中 semaglutide 已核准的 2.4 毫克中劑量。
We also presented the first results at our high Phase 3 dose, 2.4 milligram weekly or 9.6 milligrams monthly from Phase 2b VESPER-1 extension participants who escalated from placebo to 2.4 milligram weekly berobenatide. Participants achieved approximately 16% mean weight loss over 32 weeks of treatment.
我們也首次公布高第 3 期劑量的結果:每週 2.4 毫克或每月 9.6 毫克,來自第 2b 期 VESPER-1 延伸研究中由安慰劑升階至每週 2.4 毫克 berobenatide 的受試者。受試者在 32 週治療期間達到約 16% 的平均體重下降。
Importantly, there were no treatment discontinuations due to treatment-emergent adverse events in any of the arms evaluating maintenance doses moving to Phase 3. On the right is a model-based meta-analysis of data from over 32,000 participants to project 72-week weight loss for berobenatide's high monthly Phase 3 dose relative to the highest approved doses of tirzepatide and semaglutide.
重要的是,在任何評估維持劑量並推進至第 3 期的各組中,均未出現因治療期間出現的不良事件而中止治療的情況。右側為一項以模型為基礎的統合分析(meta-analysis),彙整超過 32,000 名受試者的資料,用以推估 berobenatide 的每月高劑量第 3 期方案在 72 週的減重效果,並與 tirzepatide 與 semaglutide 的最高核准劑量相對比較。
As with our clinical data from VESPER-3 monthly study, the analysis suggests berobenatide can deliver weight loss comparable to tirzepatide and potentially better than semaglutide. We see high concordance between the high-dose VESPER-1 extension study and the model's predictions, further increasing our confidence that berobenatide can potentially deliver robust efficacy and favorable GI tolerability with the convenience of a monthly therapy.
與我們在 VESPER-3 每月研究的臨床數據一致,該分析顯示 berobenatide 可帶來與 tirzepatide 相當的減重效果,且可能優於 semaglutide。我們看到高劑量 VESPER-1 延伸研究與模型預測之間具有高度一致性,進一步提升我們的信心:berobenatide 有望在具備每月一次治療便利性的同時,提供強勁療效與良好的腸胃道(GI)耐受性。
Since closing the Metsera transaction about eight months ago, we've advanced berobenatide towards the first of a series of potential approvals beginning in 2028. Today, we have three ongoing Phase 3 trials. The now fully enrolled VESPER-4 and 5 studies of weekly berobenatide and the VESPER-6 study evaluating monthly dosing. We plan to advance 10 Phase 3 studies in 2026, including one evaluating participants switching from approved weekly therapies to monthly berobenatide.
自約八個月前完成 Metsera 交易以來,我們已推進 berobenatide,朝向自 2028 年起一系列潛在核准中的第一項邁進。目前我們有三項正在進行的第 3 期試驗。包括現已完成全數收案的每週一次 berobenatide 之 VESPER-4 與 VESPER-5 研究,以及評估每月給藥的 VESPER-6 研究。我們計畫於 2026 年推進 10 項第 3 期研究,其中包括一項評估受試者由已核准的每週療法轉換至每月一次 berobenatide 的研究。
Our obesity portfolio includes injectables with the potential for monthly or longer dosing, once-daily orals and novel combinations. The most advanced combination is berobenatide plus the ultra-long-acting amylin analog 3945, which we are developing as potential first-in-category monthly medicine. We expect to report data from Phase 1/2a studies of 3945 monotherapy and berobenatide combination this year.
我們的肥胖產品組合包含可望達到每月或更長給藥間隔的注射劑、每日一次口服藥,以及新型聯合療法。最先進的聯合療法為 berobenatide 加上超長效 amylin 類似物 3945,我們正將其開發為潛在同類首創(first-in-category)的每月一次藥物。我們預期今年將公布 3945 單藥與其與 berobenatide 聯合用藥之第 1/2a 期研究數據。
As is typical for small early-stage studies, these were designed to inform starting doses and potential escalation regimens for further evaluation in Phase 2b. Our Phase 2b SOLIS-1 study has already enrolled more than half of approximately 900 planned participants. We expect data from SOLIS-1 in 2027, providing us with the first robust efficacy data from our amylin monotherapy and combination programs.
如同小型早期研究的典型設計,這些研究旨在為後續第 2b 期進一步評估提供起始劑量與可能的遞增給藥方案資訊。我們的第 2b 期 SOLIS-1 研究已收案超過預計約 900 名受試者的一半。我們預期於 2027 年取得 SOLIS-1 數據,這將為我們的 amylin 單藥與聯合療法計畫提供第一批具穩健性的療效數據。
Looking ahead, our efforts in R&D will continue to be defined by focused execution. Here, we provide visibility into the steady cadence of milestones expected over the next 12 months, including 5 regulatory decisions, 8 key readouts and 19 pivotal study starts.
展望未來,我們在研發(R&D)上的努力將持續以聚焦執行為核心。在此,我們提供未來 12 個月預期里程碑的穩定節奏之可視性,包括 5 項法規決策、8 項關鍵讀出(readouts)以及 19 項關鍵性研究啟動。
With that, I'll hand it over to Albert.
接下來我把時間交給 Albert。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you, Chris. Very nice update. And let's move to Q&A. I'm sure there are a lot of questions. Operator, please assemble the queue.
謝謝你,Chris。更新得很好。我們進入問答環節。我相信有很多問題。接線員,請安排提問順序。
Operator
Operator
(Operator Instructions) Evan Seigerman, BMO Capital Markets.
(接線員指示) Evan Seigerman,BMO Capital Markets。
Evan Seigerman - Analyst
Evan Seigerman - Analyst
Before I ask my question, I want to express my gratitude and congratulations to Dave. You'll be missed. Cecile, we're looking forward to working with you.
在我提問之前,我想向 Dave 表達感謝並致上祝賀。我們會想念你。Cecile,我們期待與你合作。
So ahead of the MEVPRO-1 data, Chris, I'd love if you could help us define how you view success. Does the study need to reproduce the Phase 1 magnitude of benefit? Would demonstrating a clinically meaningful delay in AR pathway resistance be enough to validate the mechanism and potentially support broad adoption in the clinical setting?
那麼在 MEVPRO-1 數據公布之前,Chris,我希望你能協助我們界定你們如何看待「成功」。這項研究是否需要重現第 1 期的效益幅度?若能證明在臨床上具意義地延緩 AR 路徑抗藥性,是否就足以驗證其機轉,並可能支持在臨床環境中的廣泛採用?
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Thank you very much for the question. We continue to be excited about the potential of mevrometostat to become a breakthrough therapy in prostate cancer.
非常感謝你的提問。我們仍對 mevrometostat 在前列腺癌中成為突破性療法的潛力感到振奮。
I want to also address the Q4 readout and how we are thinking about it. Phase 1 data, as you've seen, showed a hazard ratio of 0.5, doubling radiographic progression-free survival. And our data are now validated by some competitors with EZH2 or PRC2 inhibitor data in prostate cancer, although these are obviously earlier studies.
我也想談談第 4 季度讀出以及我們的思考方式。如你所見,第 1 期數據顯示風險比(hazard ratio)為 0.5,使影像學無進展存活期(radiographic progression-free survival)倍增。而我們的數據如今也獲得部分競品在前列腺癌中 EZH2 或 PRC2 抑制劑數據的驗證,儘管這些顯然是更早期的研究。
MEVPRO-1, 2 and 3 are event-driven studies, meaning control and experimental arm is where events could happen. However, the statistical analysis plan is based on a clinically meaningful benefit of approximately 30% over standard of care because that will be clinically meaningful. And it's hazard ratio based. And as I pointed out, we expect the standard of care to the control arm to be -- to perform at five to eight months in this setting.
MEVPRO-1、2 與 3 為事件驅動型研究,意即對照組與試驗組皆可能發生事件。然而,統計分析計畫是以相較標準治療約 30% 的臨床上具意義效益為基礎,因為那將具有臨床意義。且是以風險比為基礎。如我先前指出,我們預期此情境下對照組的標準治療表現約為 5 到 8 個月。
So altogether, we are confident in the performance of the experimental arm in MEVPRO-1, and we're looking forward to share update of a potential next breakthrough for prostate cancer later this year.
綜合而言,我們對 MEVPRO-1 中試驗組的表現有信心,並期待在今年稍晚分享更新,這可能成為前列腺癌的下一項突破。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Excellent. We can't wait to see the final results. Let's move to the next question.
太好了。我們迫不及待想看到最終結果。我們進入下一個問題。
Operator
Operator
Chris Schott, JPMorgan.
Chris Schott,JPMorgan。
Christopher Schott - Analyst
Christopher Schott - Analyst
Just two for me. First, I wanted to dig into the $1.5 billion increase in the non-COVID guidance. Can you just comment on how much of this is coming from Eliquis versus the rest of the business? And I guess, specifically, what's in the guidance now for Eliquis growth? I think your partner is talking about 20% to 25% growth this year.
我有兩個問題。第一個,我想深入了解非 COVID 指引上調 15 億美元的部分。你能否說明其中有多少來自 Eliquis,相較於其餘業務?另外,具體而言,目前指引對 Eliquis 的成長是如何假設的?我想你們的合作夥伴今年談到約 20% 到 25% 的成長。
Second question was just on Padcev, I guess, with the further label expansion. Just talk a little bit about how we should think about growth for that asset from here going forward.
第二個問題是關於 Padcev,我想在標籤進一步擴大之後,請談談我們應如何看待該資產從現在起往後的成長。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
All right. Why don't we start with Cecile on the guidance?
好的。我們先請 Cecile 回答指引的問題,好嗎?
Cecile Guegan - Incoming Interim Chief Financial Officer
Cecile Guegan - Incoming Interim Chief Financial Officer
Thank you, Chris, for your question. So as I described, our performance on the non-COVID portfolio is definitely very strong, both in the US and in international. And that's not one single driver. It's definitely strong execution in both US and international businesses.
謝謝你,Chris,提出問題。如我所述,我們非 COVID 產品組合的表現確實非常強勁,無論在美國或國際市場皆然。而這並非單一驅動因素。這確實是美國與國際業務兩方面的強力執行所致。
The strength of our business led to the incremental $1.5 billion above the original guidance is a reflection of, one, exceeding our expectation in Q1 and Q2 on non-COVID portfolio, but it also reflects the confidence in the momentum across our overall business. It comes from our key products, Eliquis being one of them with the drivers that our partner, BMS has described, but it's also coming from our launched and acquired products. As I mentioned earlier, 27% growth if you exclude the one-time impact that we had in 2025 and then some of the drivers that you have seen where we have very strong performance, especially on NURTEC and Padcev.
我們業務的強勁表現使非 COVID 指引較原先上調 15 億美元,反映了:第一,我們在第 1 季與第 2 季的非 COVID 產品組合表現超出預期;同時也反映我們對整體業務動能的信心。這來自我們的關鍵產品,其中 Eliquis 是之一,驅動因素如我們的合作夥伴 BMS 所描述;同時也來自我們已上市與併購取得的產品。如我先前提到,若排除 2025 年一次性影響,成長為 27%,以及你們已看到的一些驅動因素——我們在 NURTEC 與 Padcev 上的表現尤其強勁。
I'll just comment on the COVID business, just to say that, obviously, the performance that we have to date reflects the low infection level, mostly impacting COVID but we remain with our revenues for COMIRNATY in the later part of the year, consistent with the vaccination season. And as a reminder also, our COVID COMIRNATY business for international is mostly secured through the government contracts, including EC.
我也簡要評論一下 COVID 業務:截至目前的表現顯示感染水準偏低,主要影響 COVID 相關業務,但我們仍預期 COMIRNATY 的營收將在今年較後段出現,與接種季節一致。另外也提醒一下,我們在國際市場的 COVID COMIRNATY 業務多數已透過政府合約(包括 EC)獲得保障。
So overall, very strong performance across the board on our non-COVID, which translates into the raise in revenue and also translates into EPS, which is then offset by the $0.10 linked to the IPR&D.
因此,整體而言,我們在非 COVID 業務上各方面表現都非常強勁,這轉化為營收的提升,也轉化為 EPS 的提升,但之後被與 IPR&D 相關的 0.10 美元所抵銷。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Thank you. Aamir, would you like to take the second question?
謝謝。Aamir,你願意回答第二個問題嗎?
Aamir Malik - Executive Vice President, Chief US Commercial Officer
Aamir Malik - Executive Vice President, Chief US Commercial Officer
Sure. Chris, I think what's exciting on Padcev is if you think about the data Chris shared, our indicated uses for Padcev and pembro now span the entire continuum, all the way from curative intent MIBC through to metastatic disease, all independent of cisplatin eligibility. And we've executed really well against that in the growing patient population that we have. Q2 was really strong. We grew over 20%.
當然。Chris,我認為 Padcev 令人振奮之處在於,若你回想 Chris 分享的數據,我們目前對 Padcev 與 pembro 的核准適應症已涵蓋整個疾病連續譜,從以治癒為目的的 MIBC 一直到轉移性疾病,且完全不受是否符合順鉑(cisplatin)使用資格的限制。而我們也在我們所擁有、持續成長的病患族群中,對此執行得非常到位。第二季表現非常強勁。我們成長超過 20%。
A very big part of that is a terrific commercial execution from our Padcev team. We've driven la/mUC new patient share to now above 60%. And we're also really pleased with the uptake that we have in the MIBC setting. So far, most of that prescribing is in the neoadjuvant setting. And obviously, we expect those patients to reach adjuvant treatment over time.
其中很大一部分要歸功於我們 Padcev 團隊出色的商業執行。我們已將 la/mUC 的新病患市占推升至目前超過 60%。同時,我們也對在 MIBC 情境下的採用率感到非常滿意。截至目前,多數處方發生在新輔助(neoadjuvant)治療情境。而且很明顯地,我們預期這些病患會隨時間推進而進入輔助(adjuvant)治療。
To your question about what to expect, we obviously think Padcev is going to be a major growth engine for us going forward. We've had very accelerated growth to date. The pace of that growth, of course, is going to moderate from here as we reach the majority of eligible patients and prescribers in la/mUC, but we'll continue to drive that opportunity. And then the upside for us will come through MIBC and continue over time.
針對你問到的未來展望,我們顯然認為 Padcev 將會是我們未來的重要成長引擎。迄今我們的成長非常快速。當然,隨著我們在 la/mUC 中觸及大多數符合資格的病患與開立處方的醫師,成長速度將從此處開始趨於溫和,但我們仍會持續推動這個機會。接著,我們的上行空間將來自 MIBC,並會隨時間持續展開。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And I want also to emphasize that there is a very important study that we have initiated that if positive, will be very exciting, which is in bladder-sparing opportunity so that those patients will not have to go through this horrible operation. That will be a really big deal, if we will achieve it.
我也想強調,我們已啟動一項非常重要的研究;若結果為正,將會非常令人振奮,也就是在保留膀胱(bladder-sparing)的治療機會上,讓病患不必經歷這種可怕的手術。如果我們能達成,這將會是非常重大的突破。
So next question, please.
所以下一個問題,請。
Operator
Operator
Umer Raffat, Evercore ISI.
Evercore ISI 的 Umer Raffat。
Umer Raffat - Equity Analyst
Umer Raffat - Equity Analyst
I just wanted to focus on the EZH2 for a quick second and maybe a two-part question for Chris and for Aamir, if I may. Chris, I appreciate the readout is not until 4Q, but I just wanted to confirm that the trial was fully enrolled as of May, not as of last December, and that you have not hit those 302 PFS events yet. And Aamir, in a scenario this trial hits, how large a commercial opportunity is this? Should we be thinking XTANDI like?
我想先快速聚焦一下 EZH2,並且如果可以的話,對 Chris 和 Aamir 各有一個兩段式問題。Chris,我知道讀出要到第四季才會有,但我想確認一下:試驗是在今年 5 月才完成全數收案,而不是去年 12 月;而且你們尚未達到 302 個 PFS 事件。另外 Aamir,在這項試驗成功的情境下,商業機會有多大?我們應該把它想成像 XTANDI 那樣嗎?
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Thank you very much. I'll start. Thank you for the question. This trial is definitely fully enrolled, and we have not reached the events for the study, just to confirm. So events not reached as outlined in the statistical analysis plan.
非常感謝。我先開始。謝謝你的提問。這項試驗確實已完成全數收案,而且我們尚未達到該研究所需的事件數,這點我在此確認。因此,事件數尚未達標,符合統計分析計畫中的說明。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
And Aamir?
那 Aamir 呢?
Aamir Malik - Executive Vice President, Chief US Commercial Officer
Aamir Malik - Executive Vice President, Chief US Commercial Officer
Yes, Umer, thanks for the question. I think we're obviously very excited about this. If we are successful, I think the opportunity can scale across the entire disease continuum from post abiraterone to earlier line settings. So I think that's exciting for us.
好的,Umer,謝謝你的問題。我想我們顯然對此非常興奮。如果我們成功,我認為這個機會可以擴展到整個疾病連續譜,從 abiraterone 之後到更前線的治療情境。所以我認為這對我們而言很令人振奮。
The other thing I will point out is that mevro will be a 100% global opportunity for Pfizer. So we have the opportunity not only in the US but to capture share and value in markets outside the US as well, which is distinct from our situation with XTANDI. So yes, we're very excited about this.
我另外要指出的是,mevro 對輝瑞而言將是一個 100% 的全球性機會。因此,我們不僅在美國有機會,也能在美國以外的市場取得市占與價值,這點與我們在 XTANDI 的情況不同。所以是的,我們對此非常興奮。
Operator
Operator
Geoff Meacham, Citibank.
Citibank 的 Geoff Meacham。
Geoffrey Meacham - Analyst
Geoffrey Meacham - Analyst
I guess one for Chris on berobenatide, what are you guys ultimately looking for in the combo studies? Is it quarterly dosing? Is it indications outside of diabesity? Is it retatrutide like efficacy? Just wanted to get some perspective on that. And then how are you looking at the tolerability bar from a competitive standpoint?
我想問 Chris 一個關於 berobenatide 的問題:你們在聯合用藥研究中最終想要看到什麼?是每季一次給藥嗎?是 diabesity 以外的適應症嗎?是類似 retatrutide 的療效嗎?只是想了解一下你們的觀點。另外,從競爭角度來看,你們如何看待耐受性門檻?
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Thank you for the question. So as we pointed out, the amylin is unique. It's ultra-long. It's a potential monthly therapy. So the ongoing Phase 1/2a study was really to determine the optimal dose that's tolerable to start the study, the safety and the clinical pharmacology, the PK. And that then informed the 2b study, which is now ongoing SOLIS-1, which is controlled for -- with placebo for efficacy. So we expect the solid -- SOLIS-1 study to read out in 2027.
謝謝你的問題。如同我們指出的,amylin 具有獨特性。它是超長效。有潛力成為每月一次的治療。因此,目前進行中的第 1/2a 期研究,主要是為了確定可耐受的最佳起始劑量、安全性與臨床藥理(PK)。而這些結果進一步為目前正在進行的 2b 期研究 SOLIS-1 提供依據;該研究以安慰劑對照來評估療效。因此,我們預期關鍵的——SOLIS-1 研究將在 2027 年讀出。
Monthly differentiated. We obviously want to see efficacy that's more than with berobenatide alone. And what we've seen so far with the combination early on is obviously well tolerated. So we hope to report that later this year and early next year.
每月一次是差異化重點。我們當然希望看到的療效能高於單用 berobenatide。而我們目前在早期看到的聯合用藥結果,顯然具有良好的耐受性。因此,我們希望在今年稍晚以及明年初對外報告。
Operator
Operator
Akash Tewari, Jefferies.
Jefferies 的 Akash Tewari。
Akash Tewari - Analyst
Akash Tewari - Analyst
Can you talk about the efficacy advantages atirmo showed versus CDK4/6s and FOURLIGHT-1? Are we seeing signs of an early onset PFS separation that we might not see with the other molecules? And what's your current plan for first-line adjuvant with this molecule? And what's really gating you from starting that first-line adjuvant trial?
你能談談 atirmo 相較於 CDK4/6 類藥物以及 FOURLIGHT-1 所展現的療效優勢嗎?我們是否看到 PFS 早期就開始拉開差距的跡象,而這可能是其他分子看不到的?另外,你們目前對這個分子在一線輔助治療(first-line adjuvant)的計畫是什麼?以及究竟是什麼因素在限制你們啟動那個一線輔助治療試驗?
And then if I could sneak in another one. There's been a proposal from the CMS to cut reimbursement for 340B hospital payments from ASP plus 6 to ASP minus 33%. How would that affect your oncology portfolio? And what are your -- what's your chance of this proposal ultimately getting enacted?
另外如果我可以再塞一個問題。CMS 有一項提案,擬將 340B 醫院給付的補償從 ASP 加 6% 下調至 ASP 減 33%。這會如何影響你們的腫瘤產品組合?以及你們認為這項提案最終被採納施行的機率有多大?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
All right. Chris?
好的。Chris?
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Thank you. I'll start with atirmociclib. Just a reminder that the CDK4, again, internally discovered and conceptualized, very well tolerated with very few patients discontinuing treatment, which partly may address your question because of the tolerability profile. We'll share the full data later this year at a conference. But as you've seen before, we said a hazard ratio is 0.6, which is a 40% reduction in the risk of disease progression or death and it's clinically meaningful and statistic for that randomized Phase II experience.
謝謝。我先從 atirmociclib 開始。提醒一下,這是一個 CDK4(抑制劑),同樣是內部發現並提出概念的;耐受性非常好,只有極少數病患停止治療,這在某種程度上也回應了你對耐受性概況的問題。我們會在今年稍晚的一場會議上分享完整數據。但如你先前所見,我們提到其風險比(hazard ratio)為 0.6,代表疾病進展或死亡風險降低 40%,在該隨機第 II 期試驗經驗中具有臨床意義且具統計顯著性。
For atirmociclib, we're focusing on two indications, first-line ER-positive breast cancer and to your point, the adjuvant setting. A reminder for second-line ER-positive breast cancer, we are focusing on KAT6, another potential breakthrough internally discovered conceptualized medicine. For the early adjuvant setting, a significant opportunity. We believe atirmociclib could be highly differentiated here because of the tolerability. And we should release later this year the clinical trial design for the adjuvant study that should start by the end of 2026.
對於 atirmociclib,我們聚焦於兩個適應症:ER 陽性乳癌的一線治療,以及如你所提到的輔助治療情境。再提醒一下,對於 ER 陽性乳癌的二線治療,我們聚焦於 KAT6,這是另一個可能的突破性藥物,同樣由內部發現並提出概念。在早期輔助治療情境中,存在顯著的機會。我們相信 atirmociclib 在此可能因其耐受性而高度差異化。我們應會在今年稍晚公布該輔助治療研究的臨床試驗設計,並預計在 2026 年底前啟動。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Yes. Also for your question on 340B, clearly, we have articulated multiple times that there is a need to change the situation because the current situation of the program has nothing to do with the intentions of the program when it was established. And we are very active in trying to explain that to regulators and legislators. There is a mobility right now on that topic, and you have seen several announcements here and there, including some pilot programs that they are planning to implement. But I don't think it's for me appropriate at this stage to comment because we don't really know what will be the shape and form of all of that.
是的。另外,關於你對 340B 的問題,很明顯地,我們已多次闡述需要改變現況,因為該計畫目前的狀況已與其設立時的初衷毫無關聯。而且我們非常積極地向監管機關與立法者說明這一點。目前在這個議題上已有所進展,你也看到零星的多項公告,包括他們計畫推行的一些試點計畫。但我認為在這個階段由我來評論並不合適,因為我們其實還不知道這一切最終會呈現何種樣貌與形式。
Thank you, Akash. Next question.
謝謝你,Akash。下一個問題。
Operator
Operator
Terence Flynn, Morgan Stanley.
Terence Flynn,摩根士丹利。
Terence Flynn - Analyst
Terence Flynn - Analyst
Great. Albert, I recognize your recent remarks on maintaining the dividend and growing it in the future as an aspiration. But just wondering what would have to transpire in order for you and the Board to consider a cut to the dividend. When we look at your BD capacity, you mentioned $6 billion in the prepared remarks. It seems like that's somewhat constraining as you think about the opportunity set out there.
很好。Albert,我理解你最近的發言是把維持股利並在未來提高股利視為一項願景。但我想請教,必須發生什麼情況,才會讓你和董事會考慮削減股利?當我們看你們的 BD 量能時,你在事先準備的發言中提到 60 億美元。看起來在你們思考外部機會組合時,這似乎有些限制。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
No. Thank you. We feel extremely confident that we will -- even the most stretched scenarios that we are running, we will be able to maintain our dividend. So I want once and for all to make that clear to all that the dividend will be maintained and eventually through the -- after the LOE period, will be start again growing it. So that's, I think, a fundamental statement that I need to reinforce.
不會。謝謝。我們非常有信心——即使在我們所模擬的最極端情境下——我們也能維持股利。所以我想一次把話說清楚:股利將會維持,並且在——在 LOE 期間之後——將會再次開始成長。因此,我認為這是一項我需要再次強調的基本聲明。
Thank you. Next question please.
謝謝。請下一個問題。
Operator
Operator
Trung Huynh, RBC.
Trung Huynh,RBC。
Trung Huynh - Analyst
Trung Huynh - Analyst
Just a couple on immunology, please. So the vitiligo program, you've disclosed some of the TRANQUILLO 2 data there in the slides. I didn't see the TRANQUILLO 1 findings. Perhaps you can summarize the data there. Is there a consistency between those two pivotal trials?
想請教免疫學方面的兩個問題。關於白斑症(vitiligo)計畫,你們在投影片中揭露了部分 TRANQUILLO 2 的數據。我沒有看到 TRANQUILLO 1 的結果。也許你可以摘要一下那邊的數據。這兩項關鍵性試驗之間是否一致?
And then it looks like you've listed four new potential starts for Tilrekimig, the trispecific, two in AD, one versus placebo, one versus Dupi. There's an asthma one and the COPD one. Perhaps can you talk about your strategic thinking there? How quick can you start these, the trial designs, expected timelines? And perhaps can you remind us where you hope to differentiate?
另外,看起來你們列出了 Tilrekimig(這個三特異性抗體)四個新的潛在啟動項目:兩個在 AD(異位性皮膚炎),一個對安慰劑、一個對 Dupi。還有一個氣喘,以及一個 COPD。能否談談你們的策略思考?你們能多快啟動這些試驗、試驗設計與預期時程?也請提醒我們,你們希望在哪些方面做出差異化?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Chris?
Chris?
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Okay. Thank you very much. So first question on TRANQUILLO 1 and the TRANQUILLO study -- and 2, we obviously want to present later this year at a conference, the full data set, so we don't want to release all the data now. We focus on the TRANQUILLO data where 100 milligrams was the official co-primary endpoint and only shared that data today. But we've seen, as we stated in the press release for both 50 and 100 milligrams for both primary and co-primary endpoints, clinically meaningful and statistical data, which we hope to share at a conference later this year.
好的。非常感謝。先回答 TRANQUILLO 1 以及 TRANQUILLO 研究——還有 2 的問題。我們顯然希望在今年稍晚於某個會議上發表完整資料集,因此現在不想釋出所有數據。我們聚焦在 TRANQUILLO 的數據,其中 100 毫克是正式的共同主要終點(co-primary endpoint),今天只分享了那部分數據。但如同我們在新聞稿中所述,無論 50 或 100 毫克,在主要與共同主要終點上,我們都看到具臨床意義且具統計學意義的數據,希望在今年稍晚的會議上分享。
To go on regarding Tilrekimig, Again, this is an internally discovered conceptualized molecule. It's a trispecific. So it's IL-4, IL-13 and TSLP. A reminder that one of the main competitors is IL-4 and IL-13, and there's also an IL-13 only medicine recently that you would have seen. So Tilrekimig also includes TSLP, which is shown to enhance activity in allergic conditions, including in asthma and COPD.
接著談 Tilrekimig。再次強調,這是我們內部發現並概念化的分子。它是三特異性。也就是 IL-4、IL-13 與 TSLP。提醒一下,主要競品之一是針對 IL-4 與 IL-13 的藥物,另外你最近也看到一款僅針對 IL-13 的藥物。因此 Tilrekimig 也納入 TSLP,而研究顯示 TSLP 能增強過敏性疾病中的活性,包括氣喘與 COPD。
For IL-13 specifically, we believe we've got a best-in-class trispecific, especially if you look at the affinity for IL-13, the blockers of IL-13. Data previously released, which is the EASI-75 in atopic dermatitis for both the medium and high dose where we showed 52% and 50% EASI-75 placebo adjusted. And results for us that's -- I mean, that's differentiated data. It's highly encouraging. And as pointed out, we hope to start four Phase 3 studies, one against placebo, one against Dupi and also programs in asthma and COPD.
就 IL-13 而言,我們相信我們擁有同級最佳(best-in-class)的三特異性抗體,特別是如果你看 IL-13 的親和力、以及對 IL-13 的阻斷能力。先前已公布的數據是在異位性皮膚炎中的 EASI-75,中劑量與高劑量分別顯示 52% 與 50%(相對安慰劑調整後)的 EASI-75。對我們而言,這——我的意思是——這是具差異化的數據。非常令人鼓舞。如你所指出,我們希望啟動四項第三期研究:一項對安慰劑、一項對 Dupi,並且也有氣喘與 COPD 的計畫。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Yes. That's a very, very exciting asset for us. Next question, please.
是的。那對我們來說是一項非常、非常令人振奮的資產。請下一個問題。
Operator
Operator
Steve Scala, TD Cowen.
Steve Scala,TD Cowen。
Steve Scala - Analyst
Steve Scala - Analyst
I have two questions. First, on Tilrekimig, can you confirm that the trial versus Dupixent will be a true head-to-head trial powered for superiority on first-line or in first-line bio-naive patients?
我有兩個問題。第一,關於 Tilrekimig,你能否確認與 Dupixent 的試驗將會是真正的正面對決(head-to-head)試驗,並且在統計設計上以優效性(superiority)為目標,針對一線或一線生物製劑未治療(bio-naive)的患者進行?
And secondly, given small changes in the risk section language of the release, it looks like Pfizer signed a Pfizer voluntary agreement with the US government to lower drug costs and that occurred sometime in the second quarter of this year. Just curious, were there any major changes in the final version versus earlier versions? And why did it take so long?
第二,鑑於新聞稿風險段落措辭有些微變動,看起來輝瑞與美國政府簽署了一項輝瑞自願協議,以降低藥品成本,而且是在今年第二季某個時間發生。我想了解,最終版本相較於先前版本是否有任何重大變更?以及為什麼花了這麼久?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Let me take that one. That is the continuation of the memorandum of understanding that we had signed in the White House. You remember this memorable day that we resolved the MFN and tariffs altogether for the industry, I think. No, the agreements are very consistent with what you have seen for other companies and for us, and we are very pleased with the agreements.
我來回答這題。那是我們在白宮簽署的諒解備忘錄(memorandum of understanding)的延續。你還記得那個令人難忘的一天,我想我們為整個產業一起解決了 MFN 與關稅問題。不,這些協議與你在其他公司、以及在我們這裡看到的內容非常一致,我們對這些協議也非常滿意。
Now, let me move to Chris about the studies with Dupixent and how you think about the protocol, whatever you can tell us.
接下來我把問題交給 Chris,談談與 Dupixent 的研究,以及你們如何看待試驗方案——在你能透露的範圍內。
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Chris Boshoff - Executive Vice President, Chief Oncology Officer
Yes. Thank you for the question. Indeed, this will be one of the first Phase 3 trials that will be head against Dupi and powered for superiority against Dupi.
是的。謝謝你的問題。確實,這將是首批第三期試驗之一,會與 Dupi 正面對決,並且在統計設計上以相對 Dupi 的優效性為目標。
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
All right. Thank you. And the last question, please.
好的。謝謝。最後一個問題,請。
Operator
Operator
Asad Haider, Goldman Sachs.
Asad Haider,高盛。
Asad Haider - Analyst
Asad Haider - Analyst
For Albert or Cecile, just back to COVID, just given that the trend has continued to be lower than expected and understanding that the lowered $4 billion for 2026 is somewhat secured by contracts and your expectations for vaccination rates. Just curious as to what you're expecting in terms of the long-term trajectory of the franchise since that will have an impact on the high single-digit growth algorithm post 2028 that you've highlighted?
給 Albert 或 Cecile:回到 COVID 的問題,鑑於趨勢持續低於預期,並且理解你們將 2026 年下調至 40 億美元在某種程度上是由合約與你們對疫苗接種率的預期所支撐。我想了解你們對該業務長期走勢(long-term trajectory)的預期,因為這會影響你們在 2028 年後所強調的高個位數成長算法(high single-digit growth algorithm)?
And then just a quick follow-up, Albert, on BD. Just would be curious to hear any updated thoughts on how you're thinking about utilizing that lever in terms of size in the context of your remaining capacity as well as where you'd like to build out further.
另外快速追問一下,Albert,關於 BD。想請你更新一下你對運用這個槓桿的想法:在你們剩餘量能的背景下,規模上會怎麼拿捏,以及你們希望進一步擴建哪些領域?
Albert Bourla - Chairman of the Board, Chief Executive Officer
Albert Bourla - Chairman of the Board, Chief Executive Officer
Yeah. On the COVID, of course, we can ask also the commercial leaders and finance to comment on that. But let me give you at a very high level. We have this year a very low COVID season. For all respiratory seasonal diseases, this is something that we see constantly. So it could be a year that the flu is more acute and more spread than years that it is not. It could be years with RSV is more acute and years that it is not.
是的。關於 COVID,當然,我們也可以請商業端領導與財務團隊就此發表評論。但我先從非常高層次說明。今年我們的 COVID 季節性非常低。對所有呼吸道季節性疾病而言,這是我們一直都會觀察到的現象。因此,有些年份流感會比其他年份更嚴重、傳播更廣。也可能有些年份 RSV 較為嚴重,有些年份則不然。
Why we don't see big variation in the sales of the products when this happens is because they are mainly vaccines, and vaccines tend to be more independent from the infection rates. It is based on the risk of infection and people that they are committed or they are in vaccination or they are feeling that they are at risk, we'll continue doing those vaccinations irrelevant if the season is high or low. Clearly, when it is a high season, moves more people to vaccination, but the variation is very small.
之所以在這種情況下我們看不到產品銷售出現很大波動,是因為它們主要是疫苗,而疫苗的需求通常較不受感染率影響。它是基於感染風險;那些已經承諾接種、正在接種,或覺得自己有風險的人,無論季節高低都會持續接種。當然,在高峰季會促使更多人去接種,但波動幅度非常小。
When it comes to Paxlovid, this is now completely correlated with infection rates. If someone is not infected, it's not going to need Paxlovid. And this is what we see right now. So what I want to say it is that the COVID revenues, which should split it into the vaccines and the Paxlovid and the vaccines will see more stability irrelevant of the fluctuations of the infection rates with the Paxlovid, you will see high correlation if it is a high season or low season.
至於 Paxlovid,現在則與感染率完全相關。如果沒有感染,就不會需要 Paxlovid。而這正是我們目前所看到的。所以我想說的是,COVID 收入應該拆分為疫苗與 Paxlovid:疫苗的表現會更穩定,基本上不受感染率波動影響;而 Paxlovid 則會高度相關——季節高或低都會反映在其表現上。
So that's -- now can we predict what will be next year? It could be a very high season or it could be equally low the season. So that's something that you can't really predict very well. What I want to emphasize though, it is that this year where we have the lowest possible infections that we could imagine as we were setting our goals, still we were able to offset every shortfall of COVID with a super performance of the remaining of the business. And I think that was the important thing.
所以——那麼我們能預測明年會如何嗎?可能會是非常高的季節,也可能同樣是很低的季節。因此,這件事其實很難準確預測。不過我想強調的是,今年在我們設定目標時所能想像到的最低感染情境下,我們仍然能以其他業務的超預期表現,彌補 COVID 的任何缺口。我認為這才是重點。
There was also another question -- on the business development, also let me give a high level. Also, Terence before, he had asked, you have only $7 billion. Look, guys, Pfizer has placed the business development bets already, right? And we are executing on that. If you see how much we have invested in business development, it is outpacing everyone else right now since 2022, let's say, after we came back from the high -- to the normality after the COVID years.
另外還有一個問題——關於業務發展(business development),我也先從高層次說明。先前 Terence 也問過,你們只有 70 億美元。各位,輝瑞其實已經把業務發展的押注下好了,對吧?而我們正在執行這些布局。如果你看我們在業務發展上的投資金額,自 2022 年以來——也就是我們從 COVID 年代的高峰回到常態之後——目前我們的投入已經領先所有同業。
We are having 80% of these investments that we did that exceeds $80 billion already been placed in three of the transactions and all three are performing very well. So still though, we are executing because in Seagen, we are developing further the pipeline to realize much higher value. In NURTEC, we are developing new claims so that we can further finalize the value. And in Metsera, we are moving with the speed of light.
我們已經投入的這些投資中,有 80%(累計已超過 800 億美元)已經配置在三筆交易上,而且三筆都表現非常好。不過我們仍在持續執行:在 Seagen,我們正進一步開發產品線(pipeline),以實現更高的價值。在 NURTEC,我們正在開發新的適應症主張(claims),以便進一步把價值完全落實。而在 Metsera,我們正以光速推進。
As Chris said, two studies that we already initiated they are fully enrolled. And the other one, it is about to be fully enrolled. So we are moving with the speed of light. So there is a lot that already we have done. With the $6 billion, $7 billion of remaining, we will be very strategic, of course. And you should expect something on the bolt-on with the size of these opportunities.
如 Chris 所說,我們已經啟動的兩項研究都已完成受試者招募(fully enrolled)。另一項也即將完成招募。所以我們正以光速推進。因此,我們其實已經做了很多。至於剩下的 60 億、70 億美元,我們當然會非常有策略地運用。你們應該會看到一些補強型(bolt-on)的交易,規模會符合這類機會的大小。
The areas that -- we are looking at areas that we can make a difference. And clearly, oncology, it's one of them. Immuno-inflammation is another one. Primary care with obesity, it's another one. And vaccines clearly is another one, although in vaccines, you can't find much outside for business development. So I think that we have invested a lot, and we will continue doing small pieces. Those investments, we are confident will drive high single-digit growth after the LOE period, which is in '28. So that's my answer to that.
我們正在尋找我們能夠帶來差異化的領域。顯然,腫瘤學是其中之一。免疫與發炎(immuno-inflammation)是另一個。以肥胖為主的基層醫療(primary care)也是另一個。疫苗當然也是另一個領域,儘管在疫苗方面,對外可供業務發展的標的並不多。所以我認為我們已經投入很多,也會持續做一些小型布局。我們有信心,這些投資將在專利到期(LOE)期間之後——也就是 2028 年——帶動高個位數的成長。以上是我對此的回答。
And with that, I think it's time for -- to close the call. And again, I want to emphasize, I'm very pleased with what we were able to achieve. To start with, we really can prove that we know how to execute. Operationally, we are probably based on all these three years of results, one of the supreme companies in our ability to execute, reduce our cost base and still perform and overperform on our top line. I think with R&D, you will see the significant progress that we have.
那麼,我想現在是時候——結束本次電話會議了。再次強調,我對我們能達成的成果感到非常滿意。首先,我們確實證明了我們知道如何執行。在營運上,從這三年的結果來看,我們在執行力、降低成本基礎,同時仍能達成並超越營收表現方面,可能是最頂尖的公司之一。我想在研發(R&D)方面,你們也會看到我們取得的顯著進展。
And if you've noticed in the chart that Chris put together in the next 12 months, we have significant catalysts that are coming. And we are remaining optimistic that they will be successful. I want to thank my Pfizer colleagues for their dedication. And I want to wish you all a great day. Thank you.
而且如果你們注意到 Chris 在圖表中整理的未來 12 個月,我們將迎來一些重要的催化劑(catalysts)。我們仍然保持樂觀,認為它們將會成功。我要感謝輝瑞同仁的投入與奉獻。也祝各位有美好的一天。謝謝。
Operator
Operator
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.
謝謝。今天的會議到此結束。感謝各位撥冗與會並參與。您現在可以斷線。