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Operator
Operator
Thank you for standing by. Welcome to the Merck & Company, Inc., Rahway, New Jersey, USA Q2 sales and earnings conference call. (Operator Instructions) This call is being recorded. If you have any objections, you may disconnect at this time.
感謝您的支持。歡迎參加美國新澤西州拉威市默克公司第二季銷售和收益電話會議。(操作員指示)此通話正在錄音。如果您有任何異議,您可以立即斷開連接。
I would now I turn the conference over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin.
現在我將會議交給投資者關係資深副總裁 Peter Dannenbaum 先生。先生,您可以開始了。
Peter Dannenbaum - Senior Vice President, Investor Relations
Peter Dannenbaum - Senior Vice President, Investor Relations
Thank you, Shirley, and good morning, everyone. Welcome to the second-quarter of 2025 conference call for Merck & Company, Incorporated, Rahway, New Jersey, USA. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer; Caroline Litchfield, Chief Financial Officer; and Dr. Dean Li, President of Research Labs.
謝謝你,雪莉,大家早安。歡迎參加美國新澤西州拉威市默克公司 2025 年第二季電話會議。今天的電話會議發言者包括董事長兼執行長 Rob Davis、財務長 Caroline Litchfield 和研究實驗室總裁 Dean Li 博士。
Before we get started, I'd like to point out that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items that we have excluded from our non-GAAP results. There is a reconciliation in our press release.
在我們開始之前,我想指出的是,我們的 GAAP 結果中有一些項目,例如收購相關費用、重組成本以及我們從非 GAAP 結果中排除的某些其他項目。我們的新聞稿中有和解的內容。
I will also remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the Safe Harbor provision of the US Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of our company's management and are subject to significant risks and uncertainties.
我還要提醒您,我們今天所做的一些聲明可能被視為符合美國 1995 年私人證券訴訟改革法案安全港條款含義的前瞻性聲明。此類聲明是基於我們公司管理層目前的信念而做出的,並受重大風險和不確定性的影響。
If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2024 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck & Company, Incorporated, Rahway, New Jersey, USA undertakes no obligation to publicly update any forward-looking statements.
如果我們的基本假設被證明不準確或出現不確定性,實際結果可能與前瞻性陳述中的結果有重大差異。我們向美國證券交易委員會 (SEC) 提交的文件(包括 2024 年 10-K 報表中的第 1A 項)確定了某些風險因素和警示性聲明,這些因素和聲明可能導致公司的實際結果與我們今天上午做出的任何前瞻性聲明中預測的結果存在重大差異。位於美國新澤西州拉威的默克公司不承擔公開更新任何前瞻性聲明的義務。
During today's call, a slide presentation will accompany our speakers' prepared remarks. The slides, along with the earnings release, today's prepared remarks, and our SEC filings are all posted to the Investor Relations section of our company's website.
在今天的電話會議中,我們將以幻燈片演示的形式伴隨發言者的準備好的發言。這些投影片、收益報告、今天的準備好的發言稿以及我們向美國證券交易委員會提交的文件均發佈在我們公司網站的投資者關係部分。
With that, I'd like to turn the call over to Rob.
說完這些,我想把電話轉給 Rob。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Thank you, Peter. Good morning and thank you for joining today's call.
謝謝你,彼得。早安,感謝您參加今天的電話會議。
We continue to make meaningful progress in delivering our important medicines and vaccines to patients and customers while advancing our innovative pipeline. Over the past few months, we've shared a steady cadence of updates that highlight our strong clinical momentum, and our growth is increasingly benefiting from new product launches now underway with more to come.
我們在向患者和客戶提供重要藥物和疫苗的同時,不斷取得有意義的進展,同時推進我們的創新管道。在過去的幾個月裡,我們分享了穩定的更新節奏,突顯了我們強勁的臨床發展勢頭,我們的成長越來越受益於目前正在進行的新產品發布以及即將推出的更多產品。
We've also taken additional steps to augment our pipeline. Our recently announced acquisition of Verona Pharma is another example of acting decisively when science and value align and moving with urgency to achieve our business development objectives. I have increasing confidence that our science-driven strategy will continue to generate long-term value for shareholders and for all of our stakeholders.
我們也採取了額外措施來擴充我們的管道。我們最近宣布收購維羅納製藥 (Verona Pharma),這是在科學與價值一致時果斷採取行動並緊急行動以實現業務發展目標的另一個例子。我越來越相信,我們的科學驅動策略將繼續為股東和所有利害關係人創造長期價值。
Turning to our second-quarter results. We delivered performance in line with our expectations with revenue of $15.8 billion. Results reflect strength across oncology and animal health as well as increasing contributions from our new product launches, with WINREVAIR achieving $1 billion of cumulative sales in just over a year since approval. We expect to return to growth in the second half of 2025 and remain confident in our outlook for the remainder of the year.
談談我們的第二季業績。我們的業績符合預期,營收達到 158 億美元。結果反映了我們在腫瘤學和動物保健領域的實力以及新產品推出的不斷增長的貢獻,其中 WINREVAIR 自獲批以來僅一年多就實現了 10 億美元的累計銷售額。我們預計 2025 年下半年將恢復成長,並對今年剩餘時間的前景充滿信心。
I'm proud of the tangible progress we're making in expanding and advancing our research program across key therapeutic areas. We're now conducting more than 80 Phase 3 studies across a range of therapeutic areas. And we're increasingly seeing the potential we've long spoken about validated with positive clinical trial results, registrational filings, and new product launches. These proof points provide me with growing confidence that we're on track to achieve our ambitions.
我為我們在擴大和推進關鍵治療領域的研究計劃所取得的實際進展感到自豪。我們目前正在一系列治療領域進行 80 多項 3 期研究。我們越來越多地看到,我們長期以來談論的潛力已透過積極的臨床試驗結果、註冊備案和新產品發布得到驗證。這些證據讓我越來越有信心,我們正朝著實現目標的方向前進。
Moving to some notable recent news, we announced encouraging topline results from the first two Phase 3 trials evaluating in enlicitide, our oral PCSK9 inhibitor for the treatment of hyperlipidemia and for WINREVAIR, based on the HYPERION study for patients recently diagnosed with PAH.
談到最近一些值得注意的新聞,我們宣布了前兩項 3 期試驗的令人鼓舞的頂線結果,這兩項試驗分別評估了我們的口服 PCSK9 抑製劑 enlicitide(用於治療高脂血症)和 WINREVAIR(基於針對最近被診斷患有 PAH 的患者進行的 HYPERION 研究)。
On the regulatory front, the FDA approved and the ACIP recommended ENFLONSIA for the prevention of RSV in infants younger than eight months of age who are born during or entering their first RSV season. We're well prepared to support families ahead of the upcoming season.
在監管方面,FDA 批准且 ACIP 建議使用 ENFLONSIA 用於預防在第一個呼吸道合胞病毒感染季節出生或進入第一個呼吸道合胞病毒感染季節的 8 個月以下嬰兒的呼吸道合胞病毒感染。我們已做好充分準備,為即將到來的季節提供支援。
Additionally, the FDA has accepted our supplemental BLA for WINREVAIR in PAH and a new drug application for the fixed dose combination of doravirine and islatravir for the treatment of HIV.
此外,FDA 還接受了我們針對 PAH 的 WINREVAIR 的補充 BLA 以及用於治療 HIV 的固定劑量多拉韋林和伊斯拉曲韋組合的新藥申請。
At the IAS conference earlier this month, we highlighted new findings from our promising HIV pipeline, and we're excited about MK-8527, which has the potential to be the first once monthly pill for HIV prevention. We also hosted an investor event to showcase our HIV programs and the important commercial opportunity they represent.
在本月稍早的 IAS 會議上,我們重點介紹了我們有前景的 HIV 藥物研發管線的新發現,我們對 MK-8527 感到非常興奮,它有可能成為第一種每月服用一次的 HIV 預防藥丸。我們還舉辦了一場投資者活動來展示我們的愛滋病項目及其代表的重要商業機會。
Our oncology pipeline continues to break new ground. We marked the 10th earlier-stage approval for KEYTRUDA and at ASCO, presented encouraging data across multiple novel candidates, further reinforcing the potential of our portfolio to help even more patients with cancer.
我們的腫瘤學研發管線不斷取得新突破。我們迎來了 KEYTRUDA 第 10 次早期批准,並在 ASCO 上展示了多種新型候選藥物的令人鼓舞的數據,進一步增強了我們的產品組合幫助更多癌症患者的潛力。
Finally, the acquisition of Verona Pharma brings us Ohtuvayre, a novel first-in-class treatment for chronic obstructive pulmonary disease or COPD, that complements our growing cardiopulmonary program and reflects our commitment to transformative science in areas of significant unmet need. Upon closing the fourth quarter, we'll leverage our commercial capabilities to accelerate Ohtuvayre's successful launch and look forward to welcoming the Verona Pharma team to our company.
最後,收購維羅納製藥 (Verona Pharma) 為我們帶來了 Ohtuvayre,這是一種治療慢性阻塞性肺病 (COPD) 的新型一流療法,它補充了我們不斷發展的心肺項目,並反映了我們對在重大未滿足需求領域進行變革性科學的承諾。第四季結束後,我們將利用我們的商業能力加速 Ohtuvayre 的成功上市,並期待歡迎維羅納製藥團隊加入我們公司。
Overall, we are encouraged by our continued progress. Each of these impactful milestones is an important building block as we move toward a more diversified future.
整體而言,我們對自己持續的進步感到鼓舞。在我們邁向更多元化的未來的過程中,每一個具有影響力的里程碑都是重要的基石。
As I've said before, our company is entering a period of rapid transformation, which will be marked by meaningful impact on patients and the practice of medicine. And we couldn't be more excited about our future.
正如我之前所說,我們公司正在進入一個快速轉型時期,這將對患者和醫療實踐產生重大影響。我們對我們的未來感到無比興奮。
Over the past several years, we've built the largest and most diverse pipeline in our company's recent history. We have over 20 new and potential future growth drivers, including the successful recent launches of WINREVAIR and CAPVAXIVE.
在過去的幾年裡,我們建立了公司近代史上規模最大、最多樣化的管道。我們擁有 20 多個新的潛在未來成長動力,包括最近成功推出的 WINREVAIR 和 CAPVAXIVE。
We also have numerous novel late-phase compounds with potential for significant patient benefit and blockbuster commercial opportunity. Candidates such as enlicitide, tulisokibart, sac-TMT, and MK-3000, to name a few, represent potentially profound scientific advances, exactly the types of innovations that Merck is known for.
我們也擁有眾多新型後期化合物,可能為患者帶來顯著益處並帶來巨大的商業機會。僅舉幾例,enlicitide、tulisokibart、sac-TMT 和 MK-3000 等候選藥物都代表著潛在的深遠科學進步,而這些正是默克賴以聞名的創新類型。
We're committed to fully investing behind our pipeline, given the tremendous opportunities we see. And we'll continue to do so with sharp focus and discipline for the benefit of the patients we serve.
鑑於我們看到的巨大機遇,我們致力於全力投資我們的管道。我們將繼續高度重視並嚴格遵守紀律,以造福我們服務的患者。
Today, we announced a multi-year optimization initiative which will redirect investment and resources from more mature areas of our business to our burgeoning array of new growth drivers, further enable the transformation of our portfolio, and drive our next chapter of productive, innovation-driven growth. Caroline will provide more detail on this in just a moment.
今天,我們宣布了一項多年優化計劃,該計劃將把投資和資源從我們業務中更成熟的領域轉移到我們蓬勃發展的新增長動力上,進一步推動我們產品組合的轉型,並推動我們邁向富有成效、創新驅動的增長的新篇章。卡羅琳稍後將提供有關此問題的更多詳細資訊。
In summary, we're leveraging our scientific expertise to deliver the next wave of innovation that can save and improve lives around the world. My confidence in our ability to successfully navigate the KEYTRUDA LOE period increases with each new launch, data readout, and business development transaction. I continue to see the LOE as more of a hill than a cliff, and I'm confident in our ability to grow over the long term.
總而言之,我們正在利用我們的科學專業知識來推動下一波創新,以拯救和改善世界各地的生活。隨著每次新產品的推出、資料讀取和業務發展交易的進行,我對我們成功度過 KEYTRUDA LOE 時期的能力的信心不斷增強。我仍然認為 LOE 更像一座小山而不是一座懸崖,而且我對我們的長期發展能力充滿信心。
I want to thank our talented and dedicated global team for their hard work and commitment to delivering value for patients, shareholders, and for all of our stakeholders.
我要感謝我們才華橫溢、敬業奉獻的全球團隊,感謝他們的辛勤工作和致力於為患者、股東和所有利益相關者創造價值。
With that, I'll turn the call over to Caroline.
說完這些,我會把電話轉給卡洛琳。
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Thank you, Rob. Good morning. As Rob noted, second-quarter performance was in line with our expectations. I am pleased to again report that the fundamentals of our business remain strong, with continued robust global demand for our diverse, innovative portfolio of human and animal health products. Our commercial and operational execution enables us to generate value in the short term while we invest in the next generation of innovations and advance our pipeline for the long term to deliver value for all stakeholders.
謝謝你,羅布。早安.正如 Rob 所說,第二季的表現符合我們的預期。我很高興再次報告,我們的業務基礎仍然強勁,全球對我們多樣化、創新的人類和動物保健產品組合的需求持續強勁。我們的商業和營運執行使我們能夠在短期內創造價值,同時我們投資下一代創新並推進我們的長期管道,為所有利害關係人創造價值。
Now turning to our second-quarter results. Total company revenues were $15.8 billion a decrease of 2%, both nominally and excluding the impact of foreign exchange. As expected, results were impacted by a decline in sales of GARDASIL in China of approximately $1.3 billion, reducing growth by 9 percentage points. Excluding these sales, global growth was 7%, primarily driven by strength in oncology and animal health as well as new products, WINREVAIR and CAPVAXIVE, which are each off to an outstanding start.
現在來看看我們的第二季業績。公司總收入為 158 億美元,下降 2%,既包括名義收入,也包括排除外匯影響的收入。正如預期的那樣,GARDASIL 在中國的銷售額下降了約 13 億美元,導致成長率降低了 9 個百分點,從而影響了業績。除這些銷售額外,全球成長率為 7%,主要得益於腫瘤學和動物保健領域的強勁表現以及新產品 WINREVAIR 和 CAPVAXIVE,這兩款產品均取得了出色的開局。
The following revenue comments will be on an ex-exchange basis. In oncology, sales of KEYTRUDA increased 9% to $8 billion with growth in both US and international markets driven by robust demand from metastatic indications and increased uptake in earlier-stage cancers. Usage in tumors predominantly affecting women, including those with certain breast, cervical and endometrial cancers was a key contributor to growth. In addition, we saw increased use of KEYTRUDA in combination with PADCEV in first-line locally advanced urothelial cancer.
以下收入評論將以交易所為基礎。在腫瘤學領域,KEYTRUDA 的銷售額成長了 9%,達到 80 億美元,美國和國際市場的成長得益於轉移性適應症的強勁需求和早期癌症的吸收增加。用於治療主要影響女性的腫瘤,包括某些乳癌、子宮頸癌和子宮內膜癌,是成長的關鍵因素。此外,我們發現 KEYTRUDA 與 PADCEV 合併用於第一線局部晚期尿路上皮癌治療的使用增加。
We also received positive feedback from healthcare providers following the recent launch of a treatment regimen with KEYTRUDA for certain patients with resectable, locally advanced head and neck cancer based on KEYNOTE-689. This is the first perioperative anti-PD1 regimen approved for treatment of patients with this disease.
在最近推出基於 KEYNOTE-689 的某些可切除局部晚期頭頸癌患者的 KEYTRUDA 治療方案後,我們也收到了醫療保健提供者的正面回饋。這是首個獲準用於治療該疾病患者的圍手術期抗PD1方案。
Our broader oncology portfolio achieved another quarter of strong growth. Of note, WELIREG sales increased 29% to $162 million predominantly driven by increased use in certain patients with previously treated advanced renal cell carcinoma in the US.
我們更廣泛的腫瘤學產品組合又實現了一個季度的強勁成長。值得注意的是,WELIREG 的銷售額成長了 29%,達到 1.62 億美元,這主要得益於美國某些先前接受過治療的晚期腎細胞癌患者的使用增加。
In vaccines, GARDASIL sales were $1.1 billion, a decrease of 55%, driven primarily by China. Excluding China, sales declined 4% due to lower sales in Japan, reflecting the expiration of reimbursement for the catch-up cohort and timing of public sector purchases in certain international markets. Sales growth of 2% in the US was attributable to price and higher demand, partially offset by CDC purchasing patterns.
在疫苗方面,GARDASIL 的銷售額為 11 億美元,下降了 55%,主要受中國的影響。除了中國外,銷售額下降了 4%,因為日本的銷售額下降,反映了補種人群的報銷到期以及某些國際市場公共部門採購的時間表。美國銷售額成長 2%,這歸因於價格和需求增加,但被 CDC 的購買模式部分抵消。
(technical difficulty) were $129 million, driven by demand from both retail pharmacies and non-retail customers, including integrated delivery networks and clinics. We remain well positioned to help protect more adults from invasive pneumococcal disease and drive continued growth moving forward.
(技術難度)為 1.29 億美元,主要受零售藥局和非零售客戶(包括綜合配送網路和診所)的需求所推動。我們仍然處於有利地位,可以幫助保護更多成年人免受侵襲性肺炎球菌疾病的侵害,並推動未來的持續成長。
VAXNEUVANCE sales increased 20%. In the US, growth benefited by approximately $60 million from CDC stockpile activity, partially offset by competitive pressures. The benefit to VAXNEUVANCE was offset by a drawdown of CDC stockpile inventory for RotaTeq and VARIVAX, resulting in a net neutral transaction. Outside the US, growth in certain international markets was offset by a competitor preferential recommendation in Japan.
VAXNEUVANCE的銷售額成長了20%。在美國,CDC 儲備活動為成長帶來了約 6,000 萬美元的收益,但競爭壓力部分抵銷了這一收益。VAXNEUVANCE 的收益被 CDC 為 RotaTeq 和 VARIVAX 儲備庫存的減少所抵消,從而產生了淨中性交易。除美國外,某些國際市場的成長被日本競爭對手的優先推薦所抵銷。
Following the recent FDA approval and ACIP recommendation, we are excited to have started taking orders for ENFLONSIA, our monoclonal antibody for the prevention of RSV lower respiratory tract disease in infants entering their first RSV season. ENFLONSIA's compelling clinical data and operational simplicity make it an important option for parents and providers. We have made great progress in achieving the milestones necessary to help ensure a successful launch and are well positioned to help protect infants from RSV lower respiratory tract disease.
繼最近獲得 FDA 批准和 ACIP 推薦後,我們很高興開始接受 ENFLONSIA 的訂單,這是我們的單株抗體,用於預防進入第一個 RSV 季節的嬰兒的 RSV 下呼吸道疾病。ENFLONSIA 令人信服的臨床數據和操作簡單性使其成為父母和提供者的重要選擇。我們在實現確保成功發布所必需的里程碑方面取得了巨大進展,並且已做好準備幫助保護嬰兒免受 RSV 下呼吸道疾病的侵害。
In cardiovascular, WINREVAIR continued its strong momentum with global sales of $336 million. As Rob noted, in just 15 months since launch, cumulative net sales of WINREVAIR have already exceeded $1 billion. This achievement is a testament to both the impact WINREVAIR had for patients with pulmonary arterial hypertension and our ability to pair leading-edge science with execution excellence even in disease areas that are new to us.
在心血管領域,WINREVAIR 持續保持強勁勢頭,全球銷售額達 3.36 億美元。Rob 指出,自推出以來僅 15 個月,WINREVAIR 的累積淨銷售額就已超過 10 億美元。這項成就證明了 WINREVAIR 對肺動脈高壓患者的影響,也證明了我們即使在陌生的疾病領域也能將前沿科學與卓越的執行力相結合的能力。
In the US, more than 1,600 new patients received a prescription during the quarter. We are continuing to see a steady increase in the percentage of new prescriptions for patients whose background therapies do not include a prostacyclin.
在美國,本季有超過 1,600 名新患者獲得了處方。我們持續看到,針對其基礎療法中不包含前列環素的患者的新處方比例穩步上升。
Outside the US, we continue to progress with approvals and reimbursement, including in Japan, where we expect a launch later in the third quarter. Overall, the ongoing launch of WINREVAIR continues to meet our high expectations, and we look forward to positively impacting the lives of more patients with PAH.
在美國以外,我們繼續推進審批和報銷工作,其中包括在日本,我們預計將於第三季稍後在日本推出該服務。總體而言,WINREVAIR 的持續推出繼續滿足我們的高期望,我們期待對更多 PAH 患者的生活產生積極影響。
Our animal health business delivered very strong growth, with sales increasing 11%. Livestock growth reflects higher demand across all species as well as sales from the aqua portfolio acquired from Elanco. Companion animal sales growth reflects price. Growth in both segments also benefited from improved supply.
我們的動物保健業務實現了非常強勁的成長,銷售額成長了 11%。牲畜產量的成長反映了所有物種需求的增加以及從 Elanco 收購的水產產品組合的銷售。伴侶動物銷售成長反映了價格。這兩個領域的成長也受益於供應的改善。
I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin was 82.2%, an increase of 1.3 percentage points driven by favorable product mix.
現在我將向您介紹我們損益表的其餘部分,我的評論將基於非 GAAP 基礎。毛利率為82.2%,受有利的產品組合推動,成長1.3個百分點。
Operating expenses increased to $6.6 billion, including a $200 million charge related to the license agreement with Hengrui. Excluding this charge, operating expenses grew 4%, reflecting disciplined investments in support of our robust early- and late-phase pipeline as well as key growth drivers.
營運費用增至 66 億美元,其中包括與恆瑞達成的授權協議相關的 2 億美元費用。不計入這項費用,營運費用成長了 4%,反映了我們為支持強大的早期和後期管道以及關鍵成長動力而進行的嚴格投資。
Other expense was $54 million. Our tax rate was 15%. Taken together, earnings per share were $2.13.
其他支出為5400萬美元。我們的稅率是15%。總體而言,每股收益為 2.13 美元。
Turning to our outlook. As Rob noted, our company is rapidly moving to a future with a diversified set of growth drivers, each with the potential to address important unmet patient needs. We have a compelling array of novel pipeline candidates as a result of our steadfast commitment to innovation and our long-standing efforts to invest with discipline.
轉向我們的展望。正如 Rob 所說,我們的公司正在快速邁向一個擁有多元化成長動力的未來,每個成長動力都有潛力滿足患者尚未滿足的重要需求。由於我們堅定不移地致力於創新並長期努力進行有紀律的投資,我們擁有一系列引人注目的新型候選藥物。
To ensure we are well positioned to maximize the many opportunities in front of us, we have announced a multi-year optimization program. This portfolio management program will enable us to fully reinvest $3 billion of cost savings from lower growth areas of our business to higher potential areas in order to have maximum impact. It will also allow us to leverage technological advancements to enable productivity and streamline our operations.
為了確保我們能夠最大限度地利用面前的眾多機遇,我們宣布了一項多年優化計劃。這項投資組合管理計畫將使我們能夠將節省的 30 億美元成本從業務成長較低的領域重新投資到潛力較大的領域,從而產生最大的影響。它還使我們能夠利用技術進步來提高生產力並簡化我們的營運。
Taken together, our overall investment will continue to increase, a reflection of the many compelling opportunities we have. We are confident these actions will position us to deliver value for patients customers and shareholders as well as drive long-term growth.
總的來說,我們的整體投資將繼續增加,這反映出我們擁有許多引人注目的機會。我們相信,這些措施將使我們能夠為患者、客戶和股東創造價值,並推動長期成長。
Now turning to our 2025 non-GAAP guidance. We expect full-year revenue to be between $64.3 billion and $65.3 billion. This range represents growth of 1% to 2%, excluding a negative impact from foreign exchange of approximately 0.5% using mid-July rates.
現在轉向我們的 2025 年非 GAAP 指引。我們預計全年收入將在 643 億美元至 653 億美元之間。這一範圍代表著 1% 至 2% 的成長率,不包括以 7 月中旬匯率計算的約 0.5% 的外匯負面影響。
Our gross margin assumption remains approximately 82%. Our guidance of $200 million of costs related to the impact of tariffs is unchanged, pending the outcome of additional potential government actions.
我們的毛利率假設仍為 82% 左右。我們對與關稅影響相關的 2 億美元成本的預期保持不變,這取決於政府採取的進一步行動的結果。
Operating expenses are now assumed to be between $25.6 billion and $26.4 billion. This range continues to include the $300 million milestone to LaNova for the tech transfer that was completed earlier this month. This guidance does not assume the proposed acquisition of Verona or additional significant potential business development transactions.
目前預計營運費用在 256 億美元至 264 億美元之間。這一範圍還包括本月稍早完成的向 LaNova 提供的 3 億美元技術轉移里程碑。本指南不假設擬議收購維羅納或其他重大潛在業務發展交易。
Other expense is expected to be between $300 million and $400 million. We now assume a full-year tax rate between 15% and 16%. We assume approximately 2.51 billion shares outstanding. Taken together, our EPS guidance is $8.87 to $8.97. This range includes a negative impact from foreign exchange of approximately $0.15 using mid-July rates.
其他支出預計在3億至4億美元之間。我們現在假設全年稅率在 15% 至 16% 之間。我們假設流通股數約為 25.1 億股。綜合來看,我們預期每股收益為 8.87 美元至 8.97 美元。此區間包含約 0.15 美元的外匯負面影響(以 7 月中旬匯率計算)。
As you consider your models, there are a few items to keep in mind. We remain confident in the outlook for our launch products and continued growth across oncology and animal health as well as our return to growth in the second half of the year. In China, GARDASIL channel inventories remain elevated and demand continues to be soft. As a result, we will not resume shipments to China through at least the end of this year.
當您考慮模型時,需要記住幾點。我們對我們的上市產品的前景、腫瘤學和動物保健領域的持續增長以及下半年恢復增長仍然充滿信心。在中國,GARDASIL 通路庫存仍然很高,需求持續疲軟。因此,至少在今年年底之前我們都不會恢復對中國的出貨。
As we look to the balance of the year for GARDASIL, Japan will be a more significant headwind to growth in the second half of the year as we lap the increase in vaccinations from the catch-up cohort in 2024. Overall, we expect full-year growth for GARDASIL, excluding China.
當我們展望 GARDASIL 今年的平衡發展時,日本將成為下半年成長的更大阻力,因為我們將在 2024 年趕上補種族群的疫苗接種成長。總體而言,我們預計 GARDASIL 全年銷量(中國除外)將實現成長。
Next, we expect other revenue to be significantly lower in the second half of the year. While we actively manage the impact from foreign exchange through our revenue hedging program, based on mid-July rates, we expect to see a negative impact from our hedges, which is reflected in other revenue.
接下來,我們預計下半年其他收入將大幅下降。雖然我們透過收入對沖計劃積極管理外匯的影響,但根據 7 月中旬的匯率,我們預計對沖會產生負面影響,這將反映在其他收入中。
Finally, we expect operating expenses to be roughly evenly split between the third and fourth quarters, excluding business development expenses.
最後,我們預計,不包括業務發展費用,第三季和第四季的營運費用將大致平均分配。
Now turning to capital allocation, where our strategy remains unchanged. We will prioritize investments in our business to drive near- and long-term growth. We will continue to invest in our innovative pipeline including the initiation of many new late-stage clinical trials across multiple novel candidates, each of which has the potential to meaningfully address important unmet medical needs. We remain committed to our dividend with the goal of increasing it over time.
現在轉向資本配置,我們的策略保持不變。我們將優先投資我們的業務,以推動近期和長期成長。我們將繼續投資於我們的創新管道,包括啟動多個新型候選藥物的多項新的後期臨床試驗,每個候選藥物都有可能有效解決重要的未滿足的醫療需求。我們將繼續致力於提高股息,目標是隨著時間的推移增加股息。
Business development remains a high priority as evidenced by our acquisition of Verona Pharma, which we expect to finance through a combination of cash on hand, commercial paper, and new debt issuance. We maintain the ability within our strong investment-grade credit rating to pursue additional science-driven value-enhancing transactions going forward.
業務發展仍然是我們的首要任務,這從我們收購維羅納製藥 (Verona Pharma) 可以看出,我們預計透過現金、商業票據和發行新債等方式為其融資。我們保持強勁的投資等級信用評級,以在未來追求更多以科學為導向的增值交易。
We continued our pace of share repurchases with approximately $1.3 billion in the quarter. We expect to maintain a similar level of repurchases in each of the third and fourth quarters of 2025, given our strong balance sheet.
我們持續維持股票回購步伐,本季回購金額約 13 億美元。鑑於我們強勁的資產負債表,我們預計 2025 年第三季和第四季的回購水準將保持相似。
To conclude, we are confident in the outlook of our business driven by global demand for our innovative in-line portfolio and launches. We maintain our steadfast commitment to bringing forward medically significant innovations that will enable us to deliver value to patients, customers, and shareholders well into the future.
總而言之,我們對我們的業務前景充滿信心,這得益於全球對我們創新的線上產品組合和產品發布的需求。我們堅定不移地致力於推動具有重大醫學意義的創新,這將使我們能夠在未來為患者、客戶和股東創造價值。
With that, I'd now like to turn the call over to Dean.
說完這些,我現在想把電話轉給 Dean。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
Thank you, Caroline. Good morning, everyone. In the second quarter, we continued to see strong momentum across the pipeline. Today, I will cover updates from our cardiopulmonary, infectious diseases, HIV, and oncology programs.
謝謝你,卡洛琳。大家早安。在第二季度,我們繼續看到整個管道的強勁發展勢頭。今天,我將介紹我們的心肺、傳染病、愛滋病和腫瘤學計畫的最新進展。
First, on the proposed acquisition of Verona Pharma. Building on what Rob noted earlier, we have been following the strong progress of the Verona team for a number of years. Ohtuvayre is the first novel mechanism for the inhaled maintenance treatment of COPD in more than two decades. It is a dual inhibitor of phosphodiesterase 3 and 4 with bronchodilatory and non-steroidal anti-inflammatory properties.
第一,關於擬收購維羅納製藥(Verona Pharma)一事。基於 Rob 先前提到的,我們多年來一直在關注維羅納團隊的強勁進步。Ohtuvayre 是二十多年來首個用於 COPD 吸入維持治療的新型機制。它是磷酸二酯酶 3 和 4 的雙重抑制劑,具有支氣管擴張和非類固醇抗發炎特性。
As such, it is an important maintenance therapy option for patients who are persistently symptomatic. Ohtuvayre is used to improve symptoms of COPD for better breathing and to reduce the number of flare-ups.
因此,對於持續出現症狀的患者來說,它是重要的維持治療選擇。Ohtuvayre 用於改善 COPD 症狀,使呼吸更順暢,並減少發作次數。
Phase 3 trials that evaluated Ohtuvayre as monotherapy or with background therapies in patients with moderate to severe symptomatic COPD demonstrated clinically meaningful improvement in lung function. These results provided strong validation that culminated in an FDA approval in June of 2024. We are eager to complete the acquisition and work with the Verona team to advance the ongoing work in bronchiectasis and evaluate utility in additional indications, combination therapies, and alternative formulations.
針對中度至重度症狀性 COPD 患者,對 Ohtuvayre 進行單一療法或與背景療法聯合治療的 3 期臨床試驗表明,該藥物可顯著改善患者的肺功能。這些結果提供了強有力的驗證,最終於 2024 年 6 月獲得 FDA 批准。我們渴望完成此次收購,並與維羅納團隊合作,推動支氣管擴張症的持續研究,並評估其在其他適應症、聯合療法和替代配方中的實用性。
Now to focus on WINREVAIR. Evidence continues to accumulate for WINREVAIR's strong clinical benefit across a broad spectrum of patients with pulmonary arterial hypertension. The Phase 3 HYPERION trial evaluating WINREVAIR in adults recently diagnosed with PAH was stopped early based on review of available data from the program.
現在重點關注 WINREVAIR。越來越多的證據顯示 WINREVAIR 對廣大肺動脈高壓患者俱有強大的臨床益處。根據對該計畫現有數據的審查,對近期被診斷患有 PAH 的成年人使用 WINREVAIR 進行評估的 3 期 HYPERION 試驗提前停止。
Despite the early stoppage, positive topline results announced last month shows that adding WINREVAIR on top of background therapy significantly reduced the risk of clinical worsening events compared to background therapy alone. Detailed findings will be presented at a scientific congress later this year.
儘管早期停止,但上個月公佈的積極頂線結果表明,與單獨進行背景治療相比,在背景治療的基礎上添加 WINREVAIR 可顯著降低臨床惡化事件的風險。詳細研究結果將於今年稍後的科學大會上公佈。
Additionally, the FDA granted priority review for a supplemental biologics license application to update the label for WINREVAIR based on data from the Phase 3 ZENITH trial instead of PDUFA date of October 25. As a reminder, ZENITH was the first positive trial in PAH with a primary endpoint comprised entirely of major outcome measures and the first Phase 3 study in PAH to be stopped early for overwhelming efficacy. As Caroline mentioned, the Ministry of Health, Labor and Welfare in Japan has recently granted approval for WINREVAIR.
此外,FDA 還批准了一項補充生物製劑許可申請的優先審查,該申請將根據第 3 階段 ZENITH 試驗的數據(而不是 PDUFA 日期 10 月 25 日)更新 WINREVAIR 的標籤。提醒一下,ZENITH 是 PAH 領域中第一個以主要結果指標為主要終點的陽性試驗,也是 PAH 領域中第一個因療效顯著而提前停止的 3 期臨床試驗。正如 Caroline 所提到的,日本厚生勞動省最近已批准 WINREVAIR。
Moving to enlicitide, positive topline results were announced from the Phase 3 CORALreef heterozygous familial hypercholesterolemia and CORALreef AddOn clinical trials for enlicitide, our investigational, once-daily, oral PCSK9 inhibitor for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including [at least a statin]. Of note, the CDC estimates that in the United States, more than 1 million people have heterozygous familial hypercholesterolemia and approximately 86 million adults older than 20 have high cholesterol.
談到恩利塞德,我們公佈了恩利塞德的 3 期 CORALreef 雜合家族性高膽固醇血症和 CORALreef AddOn 臨床試驗的積極頂線結果,恩利塞德是我們在研的每日一次口服 PCSK9 抑製劑,用於治療正在接受降脂療法治療的高脂血症成人,包括[至少一種他汀類藥物]。值得注意的是,美國疾病管制與預防中心估計,在美國,有超過 100 萬人患有雜合子家族性高膽固醇血症,約有 8,600 萬 20 歲以上的成年人患有高膽固醇。
Both trials met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in LDL cholesterol for patients receiving enlicitide versus placebo. Detailed findings will be presented at future medical meetings.
兩項試驗均達到了其主要終點和所有關鍵次要終點,表明接受恩利塞德治療的患者的 LDL 膽固醇水平與接受安慰劑治療的患者的 LDL 膽固醇水平相比,在統計學上顯著降低,且具有臨床意義。詳細研究結果將在未來的醫學會議上公佈。
Finally, we are eagerly awaiting results from the CORALreef Lipids Phase 3 trial in the broader hyperlipidemia population, and I am pleased to report that we recently completed enrollment for the Phase 3 CORALreef Outcomes trial.
最後,我們熱切期待 CORALreef Lipids 在更廣泛的高脂血症人群中的 3 期試驗結果,我很高興地報告,我們最近完成了 3 期 CORALreef Outcomes 試驗的招募。
Next to infectious disease. Last month, the FDA approved ENFLOSIA, our long-acting, monoclonal antibody for the prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering to first RSV season. ENFLONSIA is the first and only option designed to protect infants with the same dose regardless of weight.
僅次於傳染病。上個月,FDA 批准了我們的長效單株抗體 ENFLOSIA,用於預防在第一個 RSV 季節出生或進入該季節的嬰兒的呼吸道合胞病毒下呼吸道疾病。ENFLONSIA 是第一個也是唯一一個旨在以相同劑量保護嬰兒(無論其體重如何)的藥物。
The CDC's Advisory Committee on Immunization Practices subsequently voted to recommend ENFLONSIA for use in infants younger than eight months of age for their first RSV season and include this new option in the Vaccines for Children program, an important step in ensuring access. This vote is provisional, and we await confirmation.
美國疾病管制與預防中心免疫實踐諮詢委員會隨後投票推薦將 ENFLONSIA 用於八個月以下嬰兒首次呼吸道合胞病毒感染季節,並將這一新選擇納入兒童疫苗計劃,這是確保獲得疫苗接種的重要一步。這次投票是臨時的,我們等待確認。
In vaccines, we initiated the first Phase 3 clinical trial for our investigational quadrivalent dengue vaccine, V181. The MOBILIZE-1 study will evaluate the safety, immunogenicity, and efficacy of a single dose of V181 for the prevention of dengue disease caused by any of the four dengue virus serotypes, regardless of prior exposure. According to the World Health Organization, about half of the world's population is now at risk of dengue with an estimated 100 million to 400 million infections occurring each year.
在疫苗方面,我們啟動了研究性四價登革熱疫苗 V181 的首個 3 期臨床試驗。MOBILIZE-1 研究將評估單劑量 V181 對預防四種登革熱病毒血清型引起的登革熱疾病的安全性、免疫原性和有效性,無論之前是否接觸過。根據世界衛生組織統計,目前全球約有一半人口面臨感染登革熱的風險,每年約有 1 億至 4 億人感染登革熱。
Turning to HIV. Earlier this month, we hosted an investor event coinciding with the International AIDS Society Conference on HIV Science. At the conference, we presented findings from a Phase 2 study of MK-8527, a novel NRTTI candidate being evaluated as an oral option for HIV pre-exposure prophylaxis. The data support the targeted monthly dosing schedule of MK-8527, which has the potential to enable rapid onset of protection within one hour of intake without the need for a loading dose.
轉向愛滋病毒。本月初,我們舉辦了一場投資人活動,與國際愛滋病協會愛滋病毒科學會議同時舉行。在會議上,我們介紹了 MK-8527 第 2 階段研究的結果,MK-8527 是一種新型 NRTTI 候選藥物,正在評估作為 HIV 暴露前預防的口服選擇。數據支持 MK-8527 的目標月度給藥計劃,該計劃有可能在服用後一小時內迅速發揮保護作用,而無需負荷劑量。
These findings support the initiation of two Phase 3 studies: one, to evaluate the safety and efficacy of MK-8527 among people at greater likelihood of HIV-1 exposure, EXPrESSIVE-11; and a separate study in women and adolescent girls EXPrESSIVE-10, in collaboration with the Gates Foundation. We believe MK-8527 has the potential to be an important new option for people at high risk for HIV.
這些發現支持啟動兩項 3 期研究:一項是評估 MK-8527 在 HIV-1 暴露可能性較高的人群中的安全性和有效性,即 EXPrESSIVE-11;另一項是與蓋茨基金會合作,在女性和青春期女孩中開展的單獨研究,即 EXPrESSIVE-10。我們相信 MK-8527 有可能成為 HIV 高風險族群的重要新選擇。
At IAS, we also presented data for the combination of islatravir, an investigational NRTTI anchor therapy and ulonivirine, an investigational NNRTI, being evaluated as a potential once-weekly regimen for the treatment of adults living with HIV. The Phase 2 study in adults with suppressed HIV is ongoing.
在 IAS 上,我們還展示了 islatravir(一種研究性 NRTTI 錨定療法)和 ulonivirine(一種研究性 NNRTI)的組合數據,該組合正在被評估為一種潛在的每週一次治療 HIV 感染者的成年患者的方案。針對 HIV 受抑制的成年人的第 2 階段研究正在進行中。
Finally, the FDA accepted for review, the new drug application for the fixed dose combination of doravirine and islatravir, an investigation of once-daily, oral, two-drug regimen for the treatment of adults living with HIV-1 that is virologically suppressed on antiretroviral therapy. The target action date is April 28, 2026.
最終,FDA 接受了多拉韋林和伊斯拉曲韋固定劑量組合的新藥申請進行審查,該申請研究了每日一次口服的雙藥方案,用於治療透過抗逆轉錄病毒療法達到病毒學抑制的 HIV-1 成人患者。目標行動日期為2026年4月28日。
Moving to oncology. During last month's investor event at ASCO, we showcased how we have leveraged our foundational position with KEYTRUDA to create a diverse pipeline by successfully executing on our oncology strategy and advancing key pipeline candidates. We are uniquely positioned to advance cancer care with a broad, differentiated portfolio and pipeline spanning immuno-oncology, precision medicine, and tissue targeting. The strategic ambition is to develop leading assets in all three segments so that in a world of combination therapies, our pipeline will be optimally positioned to continue to change the practice of clinical oncology.
轉向腫瘤學。在上個月於 ASCO 舉行的投資者活動上,我們展示瞭如何利用我們在 KEYTRUDA 中的基礎地位,透過成功執行我們的腫瘤學策略和推進關鍵候選藥物來創建多樣化的研發管線。我們擁有獨特的優勢,透過涵蓋免疫腫瘤學、精準醫療和組織靶向的廣泛、差異化的產品組合和產品線來推進癌症治療。我們的策略目標是開發所有三個領域的領先資產,以便在聯合療法的世界中,我們的產品線能夠處於最佳位置,並繼續改變臨床腫瘤學的實踐。
With regards to tissue targeting, through our collaboration with Daiichi Sankyo, we now have three Phase 3 trials evaluating ifinatamab deruxtecan: IDeate-Esophageal01 in unresectable advanced or metastatic esophageal squamous cell carcinoma; IDeate-Prostate01 in metastatic castrate-resistant prostate cancer; and IDeate-Lung02 in relapsed small cell lung cancer.
在組織標靶方面,透過與第一三共的合作,我們目前有三項 3 期試驗評估 ifinatamab deruxtecan:IDeate-Esophageal01 用於治療不可切除的晚期或轉移性食道鱗狀細胞癌;IDeate-Prostate01 用於治療轉移性去勢抵抗性前列腺癌;IDeate-Lung02 用於復發性小肺癌;IDeate-Lung02 治療轉移性去勢抵抗性前列腺癌;IDeate-Lung02。
KEYTRUDA continues to generate compelling data and regulatory approvals. We recently received FDA approval for its use as part of a perioperative treatment regimen for certain patients with resectable, locally advanced head and neck squamous cell carcinoma based on the KEYNOTE-689 study. This marks the 42nd indication and the 10th earlier-stage approval for a KEYTRUDA-based regimen. Earlier intervention has the potential to improve outcomes and reduce the burden of disease in this patient population.
KEYTRUDA 繼續產生令人信服的數據和監管部門的批准。根據 KEYNOTE-689 研究,我們最近獲得了 FDA 批准,將其作為某些可切除的局部晚期頭頸部鱗狀細胞癌患者的圍手術期治療方案的一部分。這是基於 KEYTRUDA 的治療方案的第 42 個適應症和第 10 個早期階段的批准。早期介入有可能改善治療結果並減輕該患者群體的疾病負擔。
In ovarian cancer, positive progression-free survival and overall survival results for KEYTRUDA plus chemotherapy with or without bevacizumab were announced in certain patients based on the Phase 3 KEYNOTE-B96 study. This is the first immune checkpoint inhibitor-based regimen to demonstrate a statistically significant overall survival benefit in ovarian cancer. We plan to present the results at an upcoming medical meeting.
在卵巢癌領域,根據 3 期 KEYNOTE-B96 研究,宣布了 KEYTRUDA 聯合化療(聯合或不聯合貝伐單抗)在某些患者中獲得了積極的無進展生存期和總生存期結果。這是第一個基於免疫檢查點抑制劑的方案,顯示對卵巢癌具有統計上顯著的整體存活益處。我們計劃在即將召開的醫學會議上展示研究結果。
And finally, the Ministry of Health, Labor and Welfare in Japan granted approval for WELIREG for certain patients with advanced renal cell carcinoma.
最後,日本厚生勞動省批准 WELIREG 用於治療某些晚期腎細胞癌患者。
As we look to the second half of this year, we anticipate multiple important milestones: in oncology, the upcoming PDUFA date for subcutaneous pembrolizumab on September 23; in the cardiopulmonary space, for WINREVAIR, the October 25 PDUFA date for the FDA label update based on the Phase 3 ZENITH trial, presentation of detailed findings from the HYPERION study, and the primary completion date in September of the Phase 2 CADENCE study in pulmonary hypertension due to left heart disease; for enlicitide, begin presenting the detailed results of Phase 3 trials from the CORALreef development program at major cardiovascular conferences; and finally, the closing of the Verona Pharma acquisition in the fourth quarter.
展望今年下半年,我們預計將出現多個重要里程碑:在腫瘤學領域,皮下注射派姆單抗的 PDUFA 日期即將於 9 月 23 日公佈;在心肺領域,對於 WINREVAIR,FDA 基於第 3 階段 ZENITH 試驗的標籤更新的 PDUFA 日期為 10 月 25 日,屆時 257 對肺動脈的研究結果為 25 月的第 25 日,而針對肺肺疾病的詳細疾病,而針對 25 月的第 2577769772 25 日,而針對肺動脈疾病的詳細疾病,而針對 26 CADENCE 研究的主要完成日期為 9 月;對於 enlicitide,將在主要心血管會議上開始展示 CORALreef 開發計劃第 3 階段試驗的詳細結果;最後,在第四季度完成對 Verona Pharma 的收購。
I look forward to providing further updates on our progress. And now I turn the call back to Peter.
我期待提供有關我們進展的進一步更新。現在我把電話轉回給彼得。
Peter Dannenbaum - Senior Vice President, Investor Relations
Peter Dannenbaum - Senior Vice President, Investor Relations
Thank you, Dean. Shirley, we're ready to begin Q&A now. We request that analysts limit themselves to one question today in order to get through as many questioners as possible. Thank you.
謝謝你,迪恩。雪莉,我們現在可以開始問答了。我們要求分析師今天只提出一個問題,以便盡可能回答提問者的問題。謝謝。
Operator
Operator
(Operator Instructions)
(操作員指示)
Daina Graybosch, Leerink Partners.
Daina Graybosch,Leerink Partners。
Daina Graybosch - Analyst
Daina Graybosch - Analyst
Hi. Thanks for the question. I wonder if you could help us understand CADENCE that you said has a September primary completion date. Specifically, can you help us put the outcomes in context?
你好。謝謝你的提問。我想知道您是否可以幫助我們了解您所說的 CADENCE 的主要完成日期是 9 月。具體來說,您能幫助我們了解結果的背景嗎?
I think you have a couple primary outcomes or primary and first secondary of PVR and a reduction or an improvement in 6-minute walk distance. What's your bar for success on both of those? And if you replicate those outcomes in Phase 3, can they support registration in this step test indication, or will you have to show benefit on a [hard] cardiovascular or a mortality outcome as well? Thank you.
我認為您有幾個主要結果或 PVR 的主要結果和次要結果,以及 6 分鐘步行距離的減少或改善。您對這兩項目標的成功標準是什麼?如果您在第 3 階段複製這些結果,它們是否可以支持在此步驟測試指示中進行註冊,或者您是否還必須證明對[硬]心血管或死亡率結果有益?謝謝。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
Daina, thank you very much. This is Dean. As you're talking about WINREVAIR, right, we have a lot of data in pulmonary arterial hypertension. The data that we're exploring outside of pulmonary arterial hypertension is in CADENCE, and it is in a select population with heart failure. It's generally one that has hemodynamics that's a little bit more reminiscent of PAH than other diseases. And so, we're really interested to study whether we can move out of PAH but focus on those who have heart failure and have a PAH physiology.
戴娜,非常感謝。這是迪恩。正如您所說,WINREVAIR,我們有很多關於肺動脈高壓的數據。我們在肺動脈高壓之外探索的數據是在 CADENCE 中,並且是針對患有心臟衰竭的特定族群。與其他疾病相比,它的血流動力學特徵更像 PAH。因此,我們非常有興趣研究是否可以擺脫 PAH,但重點是那些患有心臟衰竭和 PAH 生理的人。
In terms of the outcomes, you're right; it's PVR at 6 minutes. I would say, probably the most important thing --just because this is a patient population that's very different than a PAH population, the most important signal for me is really the PVR. I think the 6-minute walk will be also important. But to me, it's whether or not we can make a substantial impact on PVR in this patient population that is not PAH.
就結果而言,你是對的;它是 6 分鐘的 PVR。我想說,可能最重要的事情是——因為這是一個與 PAH 人群非常不同的患者群體,所以對我來說最重要的信號實際上是 PVR。我認為步行 6 分鐘也很重要。但對我來說,關鍵在於我們是否能夠對非 PAH 患者群體中的 PVR 產生實質影響。
In terms of this question of whether or not one would need to do a Phase 3, I would say that we'll have to see the data. But my expectation in front of the data is, I would imagine that the FDA would be interested in a Phase 3 trial to really demonstrate the effectiveness of this treatment in this broader patient population.
對於是否需要進行第三階段的問題,我想說我們必須查看數據。但我對數據的期望是,我認為 FDA 會對 3 期試驗感興趣,以真正證明這種治療方法在更廣泛的患者群體中的有效性。
Operator
Operator
Vamil Divan, Guggenheim Securities.
瓦米爾·迪萬,古根漢證券公司。
Vamil Divan - Equity Analyst
Vamil Divan - Equity Analyst
Great. Thanks for taking my question. Maybe I'll just stick with WINREVAIR. One is actually a follow-up to the earlier question and then one question myself.
偉大的。感謝您回答我的問題。也許我會堅持使用 WINREVAIR。其中一個實際上是對先前問題的後續,然後是我自己的一個問題。
So just following up on the CADENCE discussion, I don't know if Dean or if someone could just maybe quantify the patient population as you mentioned patients may be [dynamically] a little more skewed to what we've seen on the PAA side, just a sense of the market size. It would be helpful because we've been getting a lot of questions on how to think about the opportunity.
因此,只是跟進 CADENCE 的討論,我不知道 Dean 或其他人是否可以量化患者群體,正如您所提到的,患者可能[動態地]與我們在 PAA 方面看到的情況更加偏向,只是對市場規模的一種感覺。這將會很有幫助,因為我們已經收到了很多關於如何看待這個機會的問題。
But my other question -- my main question is actually the ex-US uptake of WINREVAIR, there's just sort of a little bit of growth in the second quarter. I know you're just kind of getting going with the launch ex-US. I'm curious, just as a relatively expensive product, recent US launch, has your ex-US strategy at all evolved given sort of the threat of most-favored-nation pricing? Are you thinking differently about what sort of pricing you might accept for WINREVAIR ex-US or which markets you may be targeting relative to what you were thinking a year or two ago?
但我的另一個問題——我的主要問題實際上是美國以外地區對 WINREVAIR 的接受程度,第二季只有一點點增長。我知道您剛開始在美國以外地區開展業務。我很好奇,作為一種最近在美國推出的相對昂貴的產品,考慮到最惠國定價的威脅,你們的美國以外戰略是否有所變化?與一兩年前相比,您是否對 WINREVAIR 在美國以外地區可能接受的定價或可能瞄準的市場有不同的看法?
And just any sense of the sort of broader ex-US market opportunity in PAH specifically for WINREVAIR would be helpful. Thank you.
只要了解 PAH 中更廣泛的美國以外市場機會(特別是對 WINREVAIR 而言)就會很有幫助。謝謝。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
Yeah. I'll take the science question. This is Dean. In relationship to patients who have left heart failure, oftentimes, they have pulmonary hypertension and not pulmonary arterial hypertension, and it's due to increased pressures in their left heart, often measured by a wedge pressure that then backs up to the pulmonary artery. That's not the patient population that we're most interested in.
是的。我將回答科學問題。這是迪恩。對於左心衰竭患者,他們經常患有肺動脈高壓而不是肺動脈高壓,這是由於左心壓力升高所致,通常透過楔壓來測量,然後回流到肺動脈。這不是我們最感興趣的患者群。
We're most interested in the patient population who has heart failure, and their pulmonary hypertension is elevated at a rate or a degree that is out of proportion to what their left heart pressures are. So in some sense, when I say a pulmonary arterial hypertension-like physiology, that's what this patient population is, and that's why we chose that.
我們最感興趣的是患有心臟衰竭的患者群體,他們的肺動脈高壓升高的速度或程度與左心壓力不成比例。因此,從某種意義上說,當我說類似肺動脈高壓的生理學時,這就是這個患者群體,這就是我們選擇它的原因。
In terms of the dimension -- how to dimension that, I would just say that to a large degree, that dimension is underdiagnosed in cardiology because there's no treatment for it. In those patients, there's very limited numbers. I would say that if you look at estimates in the absence of any treatment for these patients, I think they're going to be in the range of what -- in the range of pulmonary arterial hypertension and some factor maybe above that.
就維度而言 — — 如何確定維度,我只想說,在很大程度上,這個維度在心臟病學中未被充分診斷,因為沒有治療方法。這些患者的數量非常有限。我想說的是,如果你看一下這些患者在未接受任何治療的情況下的估計值,我認為他們的病情將處於某種範圍內——在肺動脈高壓的範圍內,甚至可能高於這個範圍。
But I do believe that unlike pulmonary arterial hypertension, where there's very good epidemiology, here in this physiology, I don't know that the epidemiology is so certain, because there hasn't been a treatment. And when oftentimes, there's not a treatment, the epidemiology, one has to be a little bit thoughtful about.
但我確實相信,與肺動脈高壓不同,肺動脈高壓有非常好的流行病學研究,而在這種生理學中,我不知道流行病學是否如此確定,因為還沒有治療方法。當很多時候沒有治療方法時,人們就必須對流行病學進行一些深思熟慮。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yeah. And Vamil, this is Rob. As it relates to the ex-US business, overall, to your point, it is still very early in the launch. And really, we're going to really see most of the reimbursements coming in the second half of this year, and that's when you're really going to see growth. But if you look at what happened in the quarter, we're actually seeing contracting is, in the markets where we are currently marketing the drug, like Germany, it's off to a good start.
是的。瓦米爾,這是羅布。至於美國以外的業務,總體而言,正如您所說,現在還處於啟動的早期階段。事實上,我們將在今年下半年看到大部分報銷金額,那時我們才會真正看到成長。但如果你看看本季發生的情況,我們實際上看到的是收縮,在我們目前正在銷售該藥物的市場,例如德國,這是一個好的開始。
What you saw from the revenues -- actually, there was a pricing adjustment in the quarter; that's why it appeared flat. But as we look forward, we do continue to see a strong opportunity for growth.
從收入來看,實際上本季度進行了價格調整;這就是為什麼收入看起來持平。但展望未來,我們確實繼續看到了強勁的成長機會。
And just to contextualize, you might recall, this is about 90,000 patients worldwide and roughly half of that is the United States. The other half is Europe and Japan. And we expect -- we, I think, recently got approval in Japan. So that's coming in the back half of the year. And then we expect broader reimbursement through Europe. So as we sit here today, it's early; but I would say it's on track.
為了便於理解,您可能還記得,全世界大約有 90,000 名患者,其中大約一半來自美國。另一半是歐洲和日本。我們預計—我認為我們最近已在日本獲得批准。所以這將在今年下半年發生。然後我們期望透過歐洲獲得更廣泛的補償。所以,雖然我們今天坐在這裡還為時過早,但我想說一切都在按計劃進行。
Operator
Operator
Chris Scott, JPMorgan.
摩根大通的克里斯·斯科特。
Christopher Schott - Analyst
Christopher Schott - Analyst
Great. Thanks so much for the question. I just wanted to dig into the $3 billion restructuring announcement. I know you mentioned in the press release you're planning to fully reinvest that. But just when we balance what seems like a large ramp in the pipeline and the Phase 3 programs over the next few years against this cost initiative, can you just help us a little bit of how we should think about either operating margins or absolute OpEx growth trending in the next few years? I'm just trying to get my hands around like what that looks like in any just qualitative sense you can provide? Thank you.
偉大的。非常感謝您的提問。我只是想深入了解 30 億美元的重組公告。我知道您在新聞稿中提到您計劃對其進行全部再投資。但是,當我們將未來幾年管道和第三階段計劃的大幅增長與這項成本計劃進行權衡時,您能否幫助我們稍微思考一下未來幾年我們應該如何看待營業利潤率或絕對運營支出的增長趨勢?我只是想弄清楚它看起來是什麼樣子的,您能提供一些定性資訊嗎?謝謝。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yeah. I appreciate that, Chris. Maybe I'll give a high-level answer, and then Caroline can fill in some of the details. If you look at what this is about, this is, as we sit here today and look at really the impressive opportunity we have with these 20-plus launches, we will and we need to fully fund behind those launches. We need to continue, and we will fully fund behind our Phase 3 pipeline on an R&D basis.
是的。我很感激,克里斯。也許我會給出一個高層次的答案,然後 Caroline 可以補充一些細節。如果你看看這是怎麼回事,這就是,當我們今天坐在這裡,真正看到這 20 多個發射給我們帶來的令人印象深刻的機會時,我們將會並且需要為這些發射提供充足的資金。我們需要繼續下去,我們將以研發的方式為我們的第三階段管道提供全額資金。
To be able to do that and to continue to -- so we will be growing our spend over time, but we want to do it productively and efficiently. And that's why we're looking to reallocate money from -- and resources from the slower growth areas of the business to fully fund into the fast-growing areas of our business.
為了能夠做到這一點並繼續下去——我們將隨著時間的推移增加支出,但我們希望有效率地做到這一點。這就是為什麼我們要重新分配資金和資源,從業務成長較慢的領域轉移到業務成長較快的領域。
So really, this $3 billion that we've referred to is a reallocation within our portfolio from the slow-growing areas to the faster-growing areas with continued expectation that you're going to see overall growth in spend, hopefully, though, at a more productive level than you would have otherwise seen, and with those investments, as I said, targeted to our pipeline, making sure we fully fund the Phase 3s and to preparing for the commercial launch. But maybe Caroline can build out some details.
所以實際上,我們提到的這 30 億美元是我們投資組合中的重新分配,從增長緩慢的領域到增長較快的領域,我們繼續期望看到支出的整體增長,但希望增長水平比你原本看到的更高,並且正如我所說,這些投資針對我們的管道,確保我們為第 3 階段提供充足的資金並為商業發布做好準備。但也許卡羅琳可以闡述一些細節。
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Yeah. So I think you've covered the headlines well, Rob. In terms of this $3 billion saving opportunity, that will come through productivity across our enterprise. It will impact the R&D line, SG&A as well as cost of goods.
是的。所以我認為你已經很好地報道了標題,羅布。就這 30 億美元的節省機會而言,這將透過提高整個企業的生產力來實現。這將影響研發線、銷售、一般及行政費用以及商品成本。
That said, we will reinvest all of that $3 billion plus further investments, especially in R&D, given the strength of our pipeline as well as in SG&A over time as we launch the new products and look to excel in the marketplace with those launches in order to drive long-term growth for our company.
也就是說,考慮到我們產品線的實力以及銷售、一般及行政費用 (SG&A) 的強勁增長,我們將把這全部 30 億美元以及進一步的投資重新投資於研發領域,隨著我們推出新產品並希望透過這些產品的推出在市場上脫穎而出,我們將逐步增加銷售、一般及行政費用,以推動公司的長期增長。
Operator
Operator
Asad Haider, Goldman Sachs.
高盛的阿薩德·海德爾 (Asad Haider)。
Asad Haider - Analyst
Asad Haider - Analyst
Great. Thanks for taking the question. A three-parter on GARDASIL. First, on GARDASIL US, you noted positive price and demand offset by CDC purchasing. Recognizing that CDC purchasing dynamics are always lumpy, they've also been a significant driver over the year. So maybe just speak to your level of confidence on the demand dynamics from that channel in the current environment.
偉大的。感謝您回答這個問題。關於 GARDASIL 的三部分內容。首先,關於 GARDASIL US,您注意到正價格和需求被 CDC 採購所抵消。認識到 CDC 的採購動態始終不穩定,它們也是今年的重要推動因素。因此,也許只是談談您對當前環境下該頻道需求動態的信心程度。
And then maybe also just as it relates to the potential for ACIP recommendation towards lower GARDASIL doses in the US, can you just update us on how you're thinking about the range of outcomes into the ACIP meeting this fall?
然後也許還因為它與 ACIP 建議在美國降低 GARDASIL 劑量的可能性有關,您能否向我們介紹一下您對今年秋季 ACIP 會議結果範圍的看法?
And then finally, on China GARDASIL, Caroline, I think you said no shipments through at least the end of this year. So any early thoughts on how you're thinking about 2026 would be helpful. Thank you.
最後,關於中國 GARDASIL,卡羅琳,我想您說過至少到今年年底都不會發貨。因此,您對 2026 年的任何早期想法都會有所幫助。謝謝。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
So this is Dean. I guess I'll take the ACIP question first, and then I'll leave the other questions to Caroline and Rob. I can't speculate what the ACIP may do. I just want to emphasize how confident we are in the safety and efficacy of G9, GARDASIL 9. But I would emphasize that I think one of the things that has become clear to the ACIP is that there is a clear disparity between the stringent clinical requirements outlined by the FDA versus the ACIP proposals that's there.
這就是 Dean。我想我會先回答 ACIP 的問題,然後再將其他問題留給 Caroline 和 Rob。我無法推測 ACIP 會做什麼。我只是想強調我們對 G9、GARDASIL 9 的安全性和有效性有多麼有信心。但我想強調的是,我認為 ACIP 已經清楚的一件事是,FDA 概述的嚴格臨床要求與 ACIP 提案之間存在明顯差異。
And the FDA has been very clear on the high evidentiary standard required for a single dose. I mean, they keep emphasizing to us efficacy against disease endpoints, not just infections, data in males and females. And this is something that's emphasized to us because we get reminded that HPV-related cancers in males is actually, I think, now trending higher than cervical cancer in females. They have a very high statistical bar in a long-term; they want very long-term durability of protection.
FDA 對單劑量所需的高證據標準非常明確。我的意思是,他們不斷向我們強調針對疾病終點的療效,而不僅僅是感染,以及男性和女性的數據。我們之所以強調這一點,是因為我們意識到,男性 HPV 相關癌症的發生率實際上比女性子宮頸癌更高。他們的長期統計標準非常高;他們希望獲得長期持久的保護。
In terms of the ACIP, there's no agenda posted for the August, September, and October. However, this was sort of a topic that got postponed. So we imagine that there will be discussion about it, but we are very clear on the safety and efficacy and the clear disparity between the FDA's high evidentiary standard and any data to date in relationship to a single dose.
就 ACIP 而言,八月、九月和十月沒有發布議程。然而,這個話題被推遲了。因此,我們想像將會對此進行討論,但我們非常清楚其安全性和有效性,以及 FDA 的高證據標準與迄今為止與單劑量相關的任何數據之間的明顯差異。
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Caroline Litchfield - Chief Financial Officer, Executive Vice President
And then in terms of the commercial, in the United States, we saw strong growth driven by price and demand, but that was mostly offset by the CDC channel, where there was a buy down in the second quarter this year greater than what we had seen in the second quarter of 2024.
然後就商業而言,在美國,我們看到了由價格和需求推動的強勁增長,但這主要被 CDC 管道所抵消,該管道今年第二季度的購買量超過了我們在 2024 年第二季度看到的購買量。
As we look at our opportunities for GARDASIL, we do expect growth in 2025 and beyond. But that does not contemplate any change in the dosing schedule for the United States. And we'll need to see what happens as the ACIP continue those discussions.
當我們審視 GARDASIL 的發展機會時,我們確實預期 2025 年及以後會出現成長。但這並不意味著美國的給藥計畫會有任何改變。我們需要觀察 ACIP 繼續進行這些討論時會發生什麼。
As it pertains to China, as noted in the prepared remarks, demand remains soft, and inventory remains elevated. We are on the ground doing all we can to activate demand, both with females as well as now with males. That said, we will not ship further product this year, and we will assess at the year-end on what the appropriate schedule should be for 2026.
就中國而言,正如準備好的評論中所指出的,需求仍然疲軟,庫存仍然高漲。我們正在實地竭盡全力激發需求,包括女性以及男性的需求。也就是說,我們今年不會再出貨任何產品,並且我們將在年底評估 2026 年的適當時間表。
I should note, GARDASIL China represents a fraction of our company now, much less than 1%. We're not counting on it for growth. We are counting on our new products, the excellent execution we have in our existing products to drive growth for our company in the second half of this year and into the future.
需要指出的是,GARDASIL 中國目前只占我們公司的一小部分,遠低於 1%。我們並不指望它能帶來成長。我們依靠我們的新產品以及現有產品的出色執行力來推動公司今年下半年及未來的成長。
Operator
Operator
Evan Seigerman, BMO Capital Markets.
艾文‧塞格曼 (Evan Seigerman),蒙特婁銀行資本市場。
Evan Seigerman - Analyst
Evan Seigerman - Analyst
Hi, all. Thank you so much for taking my question. As we think about business development going forward, I'd love if you could expand on your approach to diligence in assets between Chinese and Western companies. I'm specifically asking in context of the recent Verona acquisition versus a recent collaboration announcement by a competitor for Chinese PDE3/4 inhibitor. Thank you so much.
大家好。非常感謝您回答我的問題。當我們考慮未來的業務發展時,我希望您能詳細說明您對中國和西方公司之間資產盡職調查的方法。我特別想問的是最近 Verona 收購案與中國 PDE3/4 抑制劑競爭對手最近宣布的合作相關的情況。太感謝了。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
Well, this is Dean. We have a very high standard, whether it's from China or from the United States. But in specific relationship to your question about Verona, I mean, Verona is a company we have followed at least for five years. We were always intrigued by it because they had a dual inhibitor of PDE3 and 4 with the possibility of bronchodilatory and non-steroidal anti-inflammatory properties. And as we watched it, we had recognized that it could be the first novel mechanism, and it is now the first novel mechanism to get approved for inhalation for COPD.
嗯,這是 Dean。無論是來自中國還是來自美國,我們的標準都非常高。但具體到您關於維羅納的問題,我的意思是,我們至少關注維羅納公司五年了。我們一直對它很感興趣,因為它們具有 PDE3 和 4 的雙重抑制劑,可能具有支氣管擴張和非類固醇抗發炎特性。當我們觀察它時,我們意識到它可能是第一個新機制,現在它是第一個獲得批准用於治療 COPD 吸入的新機制。
And so for us, the fact that it's approved within the United States and the fact that we've talked to patients and physicians who use it, we believe that it lays a beachhead or groundwork for this field and our ability to move that quickly with Verona is an advantage to us, especially when we're a company who is revisiting our roots in cardiopulmonary and cardiometabolic. And we believe that there are other innovations around this pathway that will be important.
因此對我們來說,它在美國獲得批准的事實,以及我們已經與使用它的患者和醫生交談的事實,我們相信它為該領域奠定了立足點或基礎,我們能夠與維羅納一起迅速採取行動對我們來說是一個優勢,特別是當我們是一家重新審視我們在心肺和心臟代謝領域的根源的公司時。我們相信,圍繞這一途徑還有其他重要的創新。
But having that first-mover advantage within the United States and more broadly is really important. When we looked at other assets within this space, specifically related to China, they were not in that position of a first-mover advantage, which we thought was critical for Merck to enter the field.
但在美國國內以及更廣泛的範圍內擁有先發優勢確實非常重要。當我們考察該領域內的其他資產,特別是與中國相關的資產時,我們發現它們並不具備先發優勢,而我們認為這對默克進入該領域至關重要。
Operator
Operator
Umer Raffat, Evercore.
烏默·拉法特(Umer Raffat),Evercore。
Umer Raffat - Equity Analyst
Umer Raffat - Equity Analyst
Thanks for taking my question. I feel like there's been a ton of interest in the valuation paid for your Chinese partner, LaNova on the PD-1/VEGF. And my question is, considering the ongoing Phase 1 is an open-label study, can we reasonably assume everything is in fact on track, and you are still in a position to start a potentially registrational Phase 2 like a KEYNOTE-021 G in the next few months? Thank you.
感謝您回答我的問題。我感覺大家對你中國合作夥伴 LaNova 在 PD-1/VEGF 上的估值非常感興趣。我的問題是,考慮到正在進行的第 1 階段是一項開放標籤研究,我們是否可以合理地假設一切實際上都在按計劃進行,並且您仍然準備在接下來的幾個月內啟動潛在的註冊第 2 階段,例如 KEYNOTE-021 G?謝謝。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
Yeah. So this is Dean. In relationship to PD-1/VEGF, you're exactly right. We've been interested in the dual signaling in this space for some time. I would actually mark 2018 as our interest in relationship to our broad collaboration with our collaborators, Eisai.
是的。這就是 Dean。關於 PD-1/VEGF,您說得完全正確。我們對這個領域的雙重訊號感興趣已經有一段時間了。我實際上將 2018 年標記為我們與合作夥伴 Eisai 進行廣泛合作的一年。
In relationship to the LaNova program itself, everything is going exactly as planned. Now clearly, we're keeping an eye on the external environment and external data. But as related to LaNova program moving forward, that is going exactly as planned as we -- according to the plan when we initiated the partnership with LaNova.
就 LaNova 計劃本身而言,一切都按計劃進行。現在顯然,我們正在關注外部環境和外部數據。但就 LaNova 計劃的推進而言,一切都按照我們與 LaNova 合作時的計劃進行。
Operator
Operator
Akash Tewari, Jefferies.
Akash Tewari,傑富瑞。
Akash Tewari - Analyst
Akash Tewari - Analyst
Hey. Thanks so much. So we're seeing an increase in patient adds for WINREVAIR after some modest decreases over the last few quarters. What's the right cadence when you think about this going forward, not only for the rest of 2025, but really 2026 and onwards now that you have the HYPERION and ZENITH results?
嘿。非常感謝。因此,在過去幾季略有下降之後,我們看到 WINREVAIR 的患者數量增加。當您考慮未來發展時,正確的節奏是什麼?不僅是 2025 年剩餘時間,而且現在您已經獲得了 HYPERION 和 ZENITH 的結果,實際上還包括 2026 年及以後?
And really, what's your progress in terms of progressing WINREVAIR into earlier lines of setting? Are you starting to see doctors adopt this medication more aggressively?
那麼,在將 WINREVAIR 推進到早期設定方面,您取得了什麼進展?您是否開始看到醫生更積極地採用這種藥物?
And then maybe if I could just sneak in one more question, on the Hansoh GLP-1 asset, can you confirm that that drug has actually moved into the clinic? Thank you.
然後,如果我可以再偷偷問一個問題,關於 Hansoh GLP-1 資產,您能否確認該藥物確實已進入臨床?謝謝。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yeah. Maybe I'll start, and Caroline can add as well. So I appreciate the question on WINREVAIR. As we look, we've been pretty consistently adding 400 to 500 patients per month. So I wouldn't read the 1,600 in the quarter relative to -- as some shift.
是的。也許我會開始,卡洛琳也可以補充。因此,我很感謝關於 WINREVAIR 的提問。我們看到,我們每月新增患者數量一直穩定在 400 至 500 名。因此,我不會將本季的 1,600 解讀為相對於某些變化。
It has been actually pretty steady, and we do continue to expect to see that kind of steady growth going forward as we move through the rest of the year. So that would -- I think that was the first part of the question, and then maybe Caroline can take the next part.
它實際上一直相當穩定,我們確實預計在今年剩餘時間內將繼續看到這種穩定的成長。所以——我認為這是問題的第一部分,然後也許卡羅琳可以回答下一部分。
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Caroline Litchfield - Chief Financial Officer, Executive Vice President
And then the second was how we're doing in penetrating the different patient segments. What we have as of now is 75% of the use is for patients with triple therapy or a background prostacyclin. That is increasing as we move forward. And indeed, of the 1,200-plus physicians that have now prescribed WINREVAIR, more than 50% of those have prescribed the product in patients that are less severe or on dual therapy. So that gives us a lot of confidence in our future as we continue to not only help those severe patients, but increasingly move into those patients who are less severe.
第二點是我們如何滲透到不同的患者群體。截至目前,75% 的用藥針對的是接受三聯療法或以前列環素為背景的病人。隨著我們不斷前進,這一數字還在不斷增加。事實上,目前已有 1,200 多名醫生開出了 WINREVAIR,其中超過 50% 的醫生為病情較輕的患者或接受雙重治療的患者開了該產品。因此,這讓我們對未來充滿信心,因為我們不僅會繼續幫助那些病情嚴重的患者,而且還會逐漸幫助那些病情較輕的患者。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
I think it's safe to say that HYPERION and ZENITH both are contributing to that growing confidence. So everything is moving as we would hope it would as we entered the space.
我認為可以肯定地說,HYPERION 和 ZENITH 都為這種日益增長的信心做出了貢獻。當我們進入太空時,一切都按照我們所希望的那樣進行。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
I think just to mention something in WINREVAIR, I mean I've actually talked to many of the KOLs at the major centers. I think there's just a stream of information that will be helpful. It's not one event per se. I think a label update would be really important.
我想只是在 WINREVAIR 中提到一些事情,我的意思是我實際上已經與主要中心的許多 KOL 進行了交談。我認為這些資訊將會很有幫助。從本質上來說,這並不是一個單一事件。我認為標籤更新非常重要。
I do think that many of the KOLs have been waiting to see the data from HYPERION because it gives them a sense of prescribing it earlier in their journey. So they'll be very interested in that.
我確實認為許多 KOL 一直在等待看到 HYPERION 的數據,因為這讓他們有一種在旅程早期就開處方的感覺。所以他們會對此非常感興趣。
There is a patient population in PAH, for example, who are overlapped with connective tissue diseases. And they're going to want to see the culmination of all that data across trials. And that data individually, and that data pooled will be very important.
例如,肺動脈高壓 (PAH) 中有一部分患者與結締組織疾病有重疊。他們希望看到所有試驗數據的最終結果。單獨的數據和匯總的數據都非常重要。
And clearly, the continued [SOTERIA] and the fact that the adverse effects and all of this sort of thing are well within the label are things that are going to create an interest of the KOLs to begin to adopt this earlier in the journey and to other patient populations such as connective tissue disease.
顯然,[SOTERIA] 的持續性以及副作用和所有這類事情都在標籤範圍內的事實將引起 KOL 的興趣,從而開始在早期階段採用這種藥物,並將其用於結締組織疾病等其他患者群體。
In relationship to the Hansoh GLP-1, we said that it's moving to clinic this year, and everything is on schedule.
關於 Hansoh GLP-1,我們說它將在今年進入臨床階段,一切都在按計劃進行。
Operator
Operator
Terence Flynn, Morgan Stanley.
摩根士丹利的特倫斯弗林。
Terence Flynn - Analyst
Terence Flynn - Analyst
Hi. Thanks for taking the question. I was just -- I was wondering if you could offer any preliminary perspective on how a 15% tariff on pharmaceuticals would impact your 2026 outlook. Recognize you're not going to give guidance at this point, but I was just wondering if you could help frame for us the potential impact there? And then any insight if this would be phased in over time or if this would be implemented more near term? Thank you.
你好。感謝您回答這個問題。我只是——我想知道您是否可以提供一些初步看法,說明 15% 的藥品關稅將如何影響您 2026 年的展望。我知道您現在不會給出指導,但我只是想知道您是否可以幫助我們了解那裡的潛在影響?那麼,您是否有任何見解認為這是否會隨著時間的推移而分階段實施,或者是否會在近期實施?謝謝。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yeah. Terence, this is Rob. I appreciate the question. Maybe I'll take the second part of it first. So we need to see more clarity both from the administration and just overall as to exactly how this is going to play out. So it's still not clear exactly how this relates relative to the 232 investigation and the timing, so to speak, whether these apply now or will be phased in. Until there is further guidance, I can't really speak to it.
是的。特倫斯,這是羅布。我很感謝你提出這個問題。也許我會先看第二部分。因此,我們需要看到政府和整個機構更清楚地表明事情將如何發展。因此,目前尚不清楚這與 232 調查的具體關係以及時間安排,即這些措施是否現在適用或將分階段實施。除非有進一步的指導,否則我無法談論它。
But what I would tell you is as we look at -- and I don't want to get '26 guidance because we're not giving forward guidance -- but as you look at '25, I would tell you, if this was implemented immediately, it would be minimal impact based on all the work we've done around inventory management and moving our manufacturing to the US. We're very well positioned overall as we look forward to be able to do that.
但我想告訴你的是,當我們看——我不想獲得 26 年的指引,因為我們沒有提供前瞻性指引——但當你看 25 年時,我會告訴你,如果立即實施,根據我們在庫存管理和將製造轉移到美國方面所做的所有工作,它的影響將微乎其微。我們總體上處於非常有利的位置,我們期待能夠做到這一點。
And we have made very good progress as we look at even '26. We'll give the specific guidance as we move forward. But for '25, this would be minimal.
展望 26 年,我們已經取得了非常好的進展。我們將在後續工作中提供具體指導。但對 25 來說,這是微不足道的。
Operator
Operator
Courtney Breen, Bernstein.
考特尼·布林,伯恩斯坦。
Courtney Breen - Equity Analyst
Courtney Breen - Equity Analyst
Hi. Thank you so much for taking my question today. Coming back to the comments you've made around the cost savings program and the reallocation of this, can you give us a little bit of context on your intentions to -- with KEYTRUDA, specifically recognizing that that asset is coming nearer to the end of its life cycle, yet there are still many launches as well as a subcutaneous product launch ahead, and so how you're planning on a allocating in the context of KEYTRUDA, SG&A relative to the newer opportunities that you need to fund in both R&D and those new launches? Thank you very much.
你好。非常感謝您今天回答我的問題。回到您就成本節約計劃及其重新分配所發表的評論,您能否向我們介紹一下您對 KEYTRUDA 的打算?特別是認識到該資產即將接近其生命週期的末期,但仍有許多產品即將推出,以及皮下產品即將推出,那麼您計劃如何在 KEYTRUDA、SG&A 的背景下進行分配,相對於您需要在研發和新產品發布中資助的新機會?非常感謝。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yeah. Courtney, thank you for the question. As you think about where we sit in oncology -- and maybe just to contextualize, and I'll answer the question -- obviously, we've been the leader in IO therapy with KEYTRUDA. And as we've consistently said, we have every intention of not only being and continuing to be the leader but to broaden our leadership across the broader suite of oncology assets we have, which, as you know, now across the tissue targeting agents antibody-drug conjugates across all of the small molecules we have, we have one of the broader, if not the broadest, pipeline now moving forward in the oncology space.
是的。考特尼,謝謝你的提問。當您思考我們在腫瘤學領域的地位時——也許只是為了說明背景,我會回答這個問題——顯然,我們一直是 KEYTRUDA IO 治療領域的領導者。正如我們一直所說的那樣,我們不僅要成為並繼續成為領導者,而且還要擴大我們在更廣泛的腫瘤學資產中的領導地位,正如你所知,現在我們擁有的組織靶向劑抗體藥物偶聯物和所有小分子,我們擁有最廣泛的管道之一,即使不是最廣泛的,也是腫瘤學領域正在向前發展的。
So as you look at the spend, to your point, we're not necessarily looking to pull back spending on oncology. We're going to grow, and it's about reallocating the resources and adding to those resources as we start to move away from just being focused on KEYTRUDA to the broader suite of opportunities. So you're going to see other oncology gross spend as KEYTRUDA is pulled back.
因此,當您查看支出時,就您的觀點而言,我們不一定要削減腫瘤學方面的支出。我們將會成長,這意味著重新分配資源並增加這些資源,因為我們開始從僅僅關注 KEYTRUDA 轉向更廣泛的機會。因此,隨著 KEYTRUDA 的撤回,您將看到其他腫瘤學總支出。
Operator
Operator
Trung Huynh, UBS.
Trung Huynh,瑞銀。
Trung Huynh - Analyst
Trung Huynh - Analyst
Hi, all. Thanks for taking my question. It's just one on the One Big Beautiful Bill expanding the orphan drug exclusion under the IRA and how that affects the timing of KEYTRUDA's potential selection for IRA price cuts.
大家好。感謝您回答我的問題。這只是《一個美麗大法案》中關於擴大 IRA 下的孤兒藥排除範圍的一項內容,以及這將如何影響 KEYTRUDA 可能選擇 IRA 降價的時間。
So when KEYTRUDA was initially approved, it carried an orphan designation. Its first non-orphan indication was approved about a year later. So does this One Big Beautiful Bill update effectively shift KEYTRUDA's IRA selection from 2028 to 2029? And then would the presence of biosimilars by that time actually mean KEYTRUDA won't be selected for IRA? Thank you.
因此,當 KEYTRUDA 最初獲得批准時,它帶有孤兒藥稱號。大約一年後,其首個非孤兒藥適應症獲得批准。那麼,這項「一項偉大的美麗法案」的更新是否有效地將 KEYTRUDA 的 IRA 選擇從 2028 年轉移到 2029 年?那麼到那時生物相似藥的出現是否實際上意味著 KEYTRUDA 不會被選為 IRA?謝謝。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yes. I appreciate the question. So maybe just from a policy perspective, we are very supportive of the language that was put in, in support of orphan drugs. We've long believed that investing behind orphan and rare disease is important and that the more we can do to support that, it is something which will benefit patients going forward. So in that sense, we're very much supportive of what the One Big Beautiful Bill included in that regard.
是的。我很感謝你提出這個問題。因此,也許僅從政策角度來看,我們非常支持所提出的支持孤兒藥的措詞。我們一直堅信,對孤兒病和罕見疾病的投資非常重要,我們對此的支持越多,未來的患者就越受益。因此從這個意義上來說,我們非常支持《一個美麗大法案》在這方面的內容。
As it relates specifically to your question, you are correct that -- so KEYTRUDA did launch with an orphan indication in melanoma in 2014. The first non-orphan indication was in lung cancer in 2015. And based on the reading of the bill, as you've done, if you look at what is in there now, that would imply that you would expect now to see the drug selected for negotiation in '27 for implementation of the negotiated price in '29.
由於它與您的問題具體相關,您說得對——KEYTRUDA 確實在 2014 年推出了用於治療黑色素瘤的孤兒藥適應症。首個非孤兒藥適應症是2015年的肺癌。根據您對該法案的解讀,如果您看一下現在的內容,那就意味著您現在可以看到在 1927 年選定的藥品將用於談判,並在 1929 年實施談判價格。
I'm not going to speculate to whether or not it continues to be included or not as it relates to the LOE -- then pending LOE. We'll have to see how that plays out.
我不會猜測它是否繼續被包括在內,因為它與 LOE 有關——然後等待 LOE。我們將拭目以待事情會如何發展。
But I also think it's important to also understand with all this said, what we're focused on is how do we grow the business post the impending LOE of KEYTRUDA and drive for sustainability in our business long term. So that is our focus. This is nice but does not change that fundamental view of our business.
但我認為,同樣重要的是要理解,我們關注的是如何才能在 KEYTRUDA 即將到期的 LOE 之後發展業務,並推動我們業務的長期永續發展。這就是我們的重點。這很好,但並沒有改變我們業務的基本觀點。
Operator
Operator
Tim Anderson, Bank of America.
美國銀行的蒂姆·安德森。
Timothy Anderson - Analyst
Timothy Anderson - Analyst
Thank you. A couple of long-term questions for Rob. So Rob, you continue to describe the loss of KEYTRUDA as being more of a hill than a cliff. Our model shows the same, but I don't think investors and consensus really believe that. And you say you're confident in return to growth downstream of that period. So two questions.
謝謝。向 Rob 詢問幾個長期問題。所以 Rob,你繼續將 KEYTRUDA 的損失描述為更像是一座小山而不是一座懸崖。我們的模型顯示了相同的結果,但我不認為投資者和共識真的相信這一點。您說您對該時期之後恢復成長充滿信心。所以有兩個問題。
On the hill comment, can you just remind investors the biggest offsets that you see today for how losing a product that's 50% of your revenues the time of expiry will, in fact, not be a cliff? And then second, when you talk about confidence in growth over the longer term, can you put parameters around that for when that would be likely? We show trough revenues 2031; that would be three years past patent expiry. All parts, is that a realistic timeframe for when consistent growth would return?
在希爾的評論中,您能否提醒投資者,您今天看到的最大補償是,在到期時損失佔您收入 50% 的產品實際上並不會造成巨大損失?第二,當您談論對長期成長的信心時,您能否針對何時實現這一目標設定一些參數?我們顯示的是 2031 年的最低收入;這將是專利到期三年後。總的來說,這是持續成長回歸的現實時間表嗎?
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Yeah. Jim, thank you for the question. Actually, I very much appreciate it, because this is the core of the valuation thesis for our company. And my own view of this is that I do think the Street underappreciates the power of what we have in our pipeline.
是的。吉姆,謝謝你的提問。事實上,我非常感激,因為這是我們公司估值理論的核心。我個人的看法是,我確實認為華爾街低估了我們通路中擁有的力量。
And as we see that play out -- as I've consistently said, as we see those proof points continue to play out -- and I would point to WINREVAIR is the first. We're now seeing it with CAPVAXIVE. I think clesrovimab will be another one. We have enlicitide coming, sac-TMT. All of these opportunities, as they roll out, I think that confidence will grow over time.
正如我們所看到的——正如我一直說的,正如我們所看到的這些證據點繼續發揮作用——我想指出 WINREVAIR 是第一個。我們現在在 CAPVAXIVE 上看到了這一點。我認為 clesrovimab 將是另一個選擇。我們有 enlicitide 來,sac-TMT。隨著所有這些機會的推出,我認為信心會隨著時間的推移而增長。
But to your specific question, what are we focused on? Recall that we've given guidance in a broad sense to the fact that we see over $50 billion of potential opportunity from our different therapeutic areas, starting with oncology. Broad-based oncology, we now have over 60 Phase 3 clinical studies, I think, across, was it, 13 different tumor types, which will be coming over the next five years, incredibly broad across our antibody-drug conjugates, across all of the small molecules. We have the individualized neoantigen therapy; the list would go on.
但對於您的具體問題,我們關注的重點是什麼?回想一下,我們已經從廣義上給出了指導,因為我們看到了來自不同治療領域(首先是腫瘤學)超過 500 億美元的潛在機會。廣泛的腫瘤學,我們現在有超過 60 個 3 期臨床研究,我想,涵蓋了 13 種不同的腫瘤類型,這些研究將在未來五年內進行,涵蓋我們的抗體藥物偶聯物和所有小分子。我們有個別化的腫瘤新抗原治療;這樣的例子不勝枚舉。
But we think those alone are over $25 billion, and we had an opportunity at ASCO to begin to talk about some of that. And we will continue to show more of that as we go forward. Our confidence there is better today than it was even at ASCO. With every card we turn, we feel better about that going forward.
但我們認為光是這些就超過 250 億美元,我們有機會在 ASCO 上開始討論其中的一些問題。隨著我們不斷前進,我們將繼續展示更多這樣的內容。我們今天在那裡的信心甚至比在 ASCO 時還要強。每翻開一張牌,我們都會覺得未來會更好。
And then you look beyond that in the cardiometabolic, we've directed to approximately $15 billion in the cardiometabolic space, really what's foundational elements coming from WINREVAIR, which we talked about, and we continue to be very enthused by what we're seeing there. Enlicitide or oral PCSK9, we continue to think is a huge opportunity.
然後,再看看心臟代謝領域,我們已經在心臟代謝領域投入了大約 150 億美元,這實際上是來自 WINREVAIR 的基礎要素,我們對此感到非常興奮,並且我們繼續對我們在那裡看到的情況感到非常興奮。我們仍然認為 Enlicitide 或口服 PCSK9 是一個巨大的機會。
We'll continue to focus on what we have in MK-6024, which is our MASH product. We're going to see, I think, data later this year. We continue to feel very good about that. So our overall suite of the cardiometabolic space, we feel very good about. That's the $15 billion.
我們將繼續關注 MK-6024,這是我們的 MASH 產品。我認為我們將在今年稍後看到數據。我們對此仍然感到非常高興。因此,我們對心臟代謝領域的整體套件感到非常滿意。這就是150億美元。
Ophthalmology, I think, is underappreciated with a multibillion-dollar opportunity. We just recently went through our HIV portfolio with approximately $5 billion of opportunity, and we feel very good about that and the data we have and where our portfolio is going to go. It's very important.
我認為,眼科領域有著數十億美元的發展機會,但卻沒有受到重視。我們最近剛剛審查了我們的愛滋病毒投資組合,其中有大約 50 億美元的投資機會,我們對此以及我們擁有的數據和投資組合的走向感到非常滿意。這非常重要。
Immunology is another $5 billion, which is important to focus on animal health. You look at the quarter of the growth we showed in animal health this quarter. This business is going to be a fast-growing business for this company throughout our long-range plan period and is really based on a new product story very much like the human health business, [where] actually just got approval in Europe for NUMELVI, our JAK inhibitor, for dermatitis. We just got approval for our injectable, once-annual in the United States. Those are the first of multiple new product offerings coming in that business that is going to allow us to more than double it by the time we get out to the mid-2030s.
免疫學領域又花了 50 億美元,這對於關注動物健康至關重要。您可以看看本季我們在動物保健方面所呈現的成長動能。在我們的長期規劃期間,這項業務將成為公司的一項快速成長的業務,它實際上基於一個非常類似於人類健康業務的新產品故事,我們的JAK抑制劑NUMELVI實際上剛剛在歐洲獲得批准,用於治療皮膚炎。我們的注射劑剛剛在美國獲得批准,每年可使用一次。這些是該業務即將推出的多個新產品中的第一批,到 2030 年代中期,這些產品將使我們的業務規模增加一倍以上。
And then all of this excludes what else we're going to do in business development. The fact that we just did Ohtuvayre, which added another multibillion-dollar opportunity that wasn't in that $50 billion when we said it, is further block -- a building block being added as well.
所有這些都不包括我們在業務發展方面要做的其他事情。事實上,我們剛剛完成了 Ohtuvayre 項目,這又增加了一個數十億美元的機會,而這個機會並不在我們所說的 500 億美元之內,這又是一個障礙——一個正在被添加的基石。
And then we still have a lot to do on business development. We've been very clear. We're not stopping. And we have an early-stage pipeline, which as we move into '26 and especially into 27, you're going to see increasingly things coming out of our Phase 1 pipeline into our Phase 2, which will be visible that are all very exciting.
我們在業務發展方面還有很多工作要做。我們已經說得非常清楚了。我們不會停下來。我們有一個早期階段的管道,隨著我們進入26年,特別是27年,你會看到越來越多的東西從我們的第一階段管道進入第二階段,這將是非常令人興奮的。
So all of that is why if I sit and look at where we're at, I feel very good. And then obviously, we continue to have subcutaneous KEYTRUDA and the base of what we believe will be the KEYTRUDA business, which we will continue to be able to benefit for patients through those offerings.
所以,如果我坐下來看看我們所處的位置,我會感覺非常好。顯然,我們將繼續擁有皮下 KEYTRUDA,我們相信這將是 KEYTRUDA 業務的基礎,我們將繼續透過這些產品為患者帶來利益。
So I think your characterization is fair. I actually agree with it. And as far as though, as it looks to how quickly we get back to growth, it would be one where I would say -- I don't want to give specifics on years, but we've been very clear. We want to minimize the cliff, which I think we have done. That's why I talk about the hill, and we want to get back to growth quickly. And I do see a path to do that, and I'm confident we will.
所以我認為你的描述是公平的。我其實同意這一點。至於我們恢復成長的速度有多快,我想說——我不想透露具體年份,但我們已經非常清楚了。我們希望將懸崖降到最低,我認為我們已經做到了。這就是我談論山的原因,我們希望迅速恢復成長。我確實看到了實現這一目標的途徑,並且我相信我們能夠做到。
And I think if you go back to the JPM presentation we gave, we had a slide in there which was a representation, if you will, the cone of opportunity within our long-range plan, that kind of gives a profile very similar to what you just described.
我認為,如果你回顧我們所做的 JPM 演示文稿,你會發現其中有一張幻燈片,如果你願意的話,它代表了我們長期計劃中的機會錐,它給出了與你剛才描述的非常相似的概況。
Peter Dannenbaum - Senior Vice President, Investor Relations
Peter Dannenbaum - Senior Vice President, Investor Relations
Great. Thanks, Tim. I know we're over time. We have time for a few more questions. So Shirley, next question, please.
偉大的。謝謝,蒂姆。我知道我們已經超時了。我們還有時間回答幾個問題。那麼雪莉,請問下一個問題。
Operator
Operator
Alex Hammond, Wolfe Research.
沃爾夫研究公司的亞歷克斯·哈蒙德。
Alexandria Hammond - Equity Analyst
Alexandria Hammond - Equity Analyst
Thanks for taking the question. For enlicitide, the team has highlighted it as a platform to add other cardiometabolic assets on to. With that context, what combinations and indications could we expect, and when could we receive updates? Thank you.
感謝您回答這個問題。對於恩利塞德,團隊強調它是添加其他心臟代謝資產的平台。在這種背景下,我們可以期待哪些組合和跡象,何時可以收到更新?謝謝。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
Yeah. So thank you very much for the question. So just to reset, our ambition is that this is going to be the first oral PCSK9, and it will not just be first. It will be the best in relationship to everything that we've seen from competitor data.
是的。非常感謝您的提問。因此,重新設定目標,我們的目標是使其成為第一個口服 PCSK9,而不僅僅是第一個。從我們從競爭對手的數據中看到的所有方面來看,它將是最好的。
And we expect to have it be the most effective oral LDL-lowering option, and it should have confidence in cardiovascular outcomes that are comparable, but actually, we believe could be better than the biologics. And we think that with the data that we have, we recognize that 70% of patients with ASCVD, even treated with statins, do not treat the LDL cholesterol.
我們期望它成為最有效的口服降低 LDL 藥物,並且它對心血管結果具有可比性的信心,但實際上,我們相信它可能比生物製劑更好。我們認為,根據我們掌握的數據,我們認識到 70% 的 ASCVD 患者即使接受他汀類藥物治療,也無法治療 LDL 膽固醇。
So when you think about that, LDL is one axis in relationship to cardiovascular outcomes. And LDL, clearly, there would be combinations that you would make with enlicitide to even deepen that response and more. So that's a combination that would be advanced -- that can advance quickly. But I think there's also evolving data in relationship, and we will see that probably from others in relationship to, for example, Lp(a).
因此,當您考慮到這一點時,LDL 是與心血管結果相關的軸。顯然,LDL 可以與 enlicitide 結合使用,以加深這種反應,甚至產生更多效果。所以這是一個先進的組合——可以快速進步。但我認為,關係中也有不斷發展的數據,我們可能會從與 Lp(a) 等相關的其他人那裡看到這一點。
I think in that patient population, if reducing Lp(a) is indeed shown to be important for lowering cardiovascular outcomes, then the potential of having an Lp(a) molecule that can do that -- but also recognizing that PCSK9 adds further reduction of Lp(a) and in the patient populations who have high Lp(a), the way that I've treated them is I give them PCSK9 -- that a combination there may be something that's really important. And then in the future, other combinations potentially related to other axes -- I talked about LDL, Lp(a) -- we would clearly be interested in inflammatory accesses and other accesses in combination.
我認為,在該患者群體中,如果降低 Lp(a) 確實被證明對降低心血管結果很重要,那麼擁有能夠做到這一點的 Lp(a) 分子的潛力 - 但也要認識到 PCSK9 可以進一步降低 Lp(a),並且在 Lp(a) 水平高的患者群體中,我給他們服用 PCSK9 進行治療 - 這種組合可能很重要。然後在未來,其他組合可能與其他軸相關 - 我談到了 LDL、Lp(a) - 我們顯然會對發炎路徑和其他路徑的組合感興趣。
So enlicitide is a really important molecule. It is a molecule that we believe can serve as a platform to be driving cardiovascular outcomes in increments of 20%, 25%, 30%, and we're very excited for that future.
因此,enlicitide 是一種非常重要的分子。我們相信,這種分子可以作為一個平台,以 20%、25%、30% 的增量推動心血管結果,我們對未來感到非常興奮。
Peter Dannenbaum - Senior Vice President, Investor Relations
Peter Dannenbaum - Senior Vice President, Investor Relations
We have time for two more questions, please.
我們還有時間回答另外兩個問題。
Operator
Operator
James Shin, Deutsche Bank.
德意志銀行的詹姆斯辛 (James Shin)。
James Shin - Research Analyst
James Shin - Research Analyst
Good morning. Thank you for squeezing me in. One for Dean. Dean, I appreciate everything is on schedule for MK-2010, but was Merck notified of Sino Biopharm's interest in LaNova? And does that have any bearing on Merck's commitment to 2010 or the development of a PD-1/VEGF bispecific more broadly? Thank you.
早安.謝謝你把我擠進來。一個給 Dean。院長,我知道 MK-2010 的一切都按計劃進行,但是默克公司是否已獲悉中國生物製藥公司對 LaNova 的興趣?這對默克公司 2010 年的承諾或更廣泛的 PD-1/VEGF 雙特異性開發有何影響?謝謝。
Dean Li - Executive Vice President, President - Merck Research Laboratories
Dean Li - Executive Vice President, President - Merck Research Laboratories
I would just emphasize, our commitment is based on our interest in the space since 2018. So our commitment has not changed. And as I've said, the LaNova program that we have is moving forward as planned. In terms of notification or not notification, that's something that we don't comment in terms of business development.
我想強調的是,我們的承諾是基於我們自 2018 年以來對該領域的興趣。所以我們的承諾沒有改變。正如我所說,我們的 LaNova 計劃正在按計劃推進。至於是否通知,就業務發展而言,我們不予評論。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Correct.
正確的。
Operator
Operator
Mohit Bansal, Wells Fargo.
富國銀行的 Mohit Bansal。
Mohit Bansal - Analyst
Mohit Bansal - Analyst
Great. Thank you very much for taking my question. So I have a question regarding the guidance. So if I compare the guidance on FX basis versus the prior quarter, it does seem like you have lowered the upper end of the growth from (technical difficulty) just wanted to understand if there is a change in the operational business that we need to be aware about. Thank you.
偉大的。非常感謝您回答我的問題。所以我對該指導有一個疑問。因此,如果我將外匯基礎上的指導與上一季進行比較,似乎您已經降低了成長的上限(技術難度),只是想了解營運業務是否存在我們需要注意的變化。謝謝。
Peter Dannenbaum - Senior Vice President, Investor Relations
Peter Dannenbaum - Senior Vice President, Investor Relations
Your line cut out. I think the question was about the reduction -- you see a reduction in the guidance, but can you talk about guidance, Caroline?
您的線路斷了。我認為問題是關於減少的——你看到指導有所減少,但是你能談談指導嗎,卡羅琳?
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Caroline Litchfield - Chief Financial Officer, Executive Vice President
Sure. So the guidance that we've given this quarter is to maintain the midpoint for revenues and to increase EPS by $0.03. There was a very modest tailwind from foreign exchange, and that has really offset a few headwinds.
當然。因此,我們本季給予的指引是維持收入中位數,並將每股盈餘提高0.03美元。外匯因素帶來了非常溫和的利好,這確實抵消了一些不利因素。
The first would be a low level of COVID cases during the summer season, which has impacted our outlook for LAGEVRIO. The second is we have seen an early entrant of a biosimilar for pembrolizumab in Argentina, which has impacted revenues there.
首先是夏季 COVID 病例水平較低,這影響了我們對 LAGEVRIO 的展望。第二,我們看到阿根廷早期出現了一種 pembrolizumab 生物相似藥,這對那裡的收入產生了影響。
All of that said, we are confident in our ability to drive growth in our business this year of between 1% and 2%. And when you exclude the impact of the headwind of China's GARDASIL, we have underlying growth of between 6% and 8%. So we're confident in our future despite the uncertain macroenvironment that does exist for our industry.
綜上所述,我們有信心今年實現 1% 至 2% 的業務成長。如果排除中國 GARDASIL 疫苗不利因素的影響,我們的潛在成長率將在 6% 至 8% 之間。因此,儘管我們的行業確實存在不確定的宏觀環境,但我們對未來充滿信心。
Peter Dannenbaum - Senior Vice President, Investor Relations
Peter Dannenbaum - Senior Vice President, Investor Relations
Great. Thank you, all, very much for your questions. As always, Investor Relations is available for any follow-ups. Thank you very much.
偉大的。非常感謝大家的提問。與往常一樣,投資者關係部門可以隨時跟進任何事宜。非常感謝。
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Robert Davis - Chairman of the Board, President, Chief Executive Officer
Thank you.
謝謝。
Operator
Operator
Thank you. This concludes today's conference. We thank you for your participation. At this time, you may disconnect your lines.
謝謝。今天的會議到此結束。我們感謝您的參與。此時,您可以斷開線路。