默克藥廠 (MRK) 2025 Q3 法說會逐字稿

Welcome to the Merck & Co, Inc. Rahway, New Jersey, USA third quarter sales and earnings conference call. (Operator Instructions) This call is being recorded. If you have any objections, you may disconnect at this time.

歡迎參加美國新澤西州拉威市默克公司第三季銷售和收益電話會議。（操作員指示）本次通話正在錄音。如果您有任何異議，可以立即斷開連接。

I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin.

現在我將把電話交給投資者關係高級副總裁彼得·丹嫩鮑姆先生。先生，您可以開始了。

Thank you, Julie, and good morning, everyone. Welcome to the third quarter 2025 conference call for Merck & Co, Inc., 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，朱莉，大家早安。歡迎參加美國新澤西州拉威市默克公司2025年第三季電話會議。出席今天電話會議的有：董事長兼執行長羅伯戴維斯；財務長卡洛琳利奇菲爾德；以及研究實驗室總裁李迪安博士。

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.

在開始之前，我想指出，我們的 GAAP 結果中包含一些項目，例如收購相關費用、重組成本以及其他一些項目，這些項目已從我們的非 GAAP 結果中排除。我們的新聞稿中已達成和解。

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. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

我還要提醒各位，我們今天所作的一些陳述可能被視為1995年美國私人證券訴訟改革法案安全港條款意義上的前瞻性陳述。此類聲明是基於本公司管理層目前的信念，但存在重大風險和不確定性。如果我們的基本假設被證明是不準確的，或者不確定因素成為現實，則實際結果可能與前瞻性聲明中列出的結果有重大差異。

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 & Co, Inc., Rahway, New Jersey, USA undertakes no obligation to publicly update any forward-looking statements.

我們在提交給美國證券交易委員會的文件，包括 2024 年 10-K 表格中的第 1A 項，列出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業績與我們今天早上發表的任何前瞻性聲明中預測的業績存在重大差異。美國新澤西州拉威市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. These 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.

在今天的電話會議上，我們將配合幻燈片演示，向發言人發表準備好的演講。這些幻燈片，連同盈利報告、今天的準備好的發言稿和我們向美國證券交易委員會提交的文件，都已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.

接下來，我想把電話交給羅布。

Thank you, Peter. Good morning, and thank you for joining today's call. We continue to make meaningful progress in using the power of leading-edge science to save and improve lives around the world. We're delivering value to patients and customers today through our innovative portfolio of medicines and vaccines, and we're securing our future by making important investments in our pipeline, the strongest and deepest in recent memory.

謝謝你，彼得。早安，感謝各位參加今天的電話會議。我們不斷利用尖端科學的力量拯救和改善世界各地人們的生命，並取得了有意義的進展。我們透過創新的藥品和疫苗組合，為患者和客戶創造價值；同時，我們也透過對研發管線進行重要投資，確保我們的未來發展。我們的研發管線是近年來最強大、最深入的。

We now have approximately 80 Phase 3 trials underway across a diverse array of therapeutic areas, with important readouts coming over the next year in cardio-pulmonary, immunology, HIV, ophthalmology and, of course, oncology.

目前，我們在各種治療領域開展了大約 80 項 3 期試驗，未來一年將在心肺、免疫學、愛滋病毒、眼科學以及腫瘤學等領域公佈重要結果。

We're investing behind more than 20 compelling launch opportunities, some already underway. These programs will transform our commercial portfolio and fuel future growth, with over $50 billion of revenue opportunity by the mid-2030s, and we remain committed to the pursuit of disciplined, science- and value-driven business development to further augment our expansive pipeline.

我們正在投資 20 多個極具吸引力的上市機會，其中一些已經開始實施。這些項目將改變我們的商業組合，並推動未來的成長，到 2030 年代中期，將帶來超過 500 億美元的收入機會。我們將繼續致力於以嚴謹的科學和價值為導向的業務發展，以進一步增強我們龐大的產品線。

In the third quarter, we continued to successfully execute on our strategy with important pipeline advancements, significant approvals, and successful new product launches. Additionally, in October, we completed the strategic acquisition of Verona Pharma. This provides us yet another important growth driver with multibillion-dollar commercial potential into the next decade.

第三季度，我們繼續成功執行我們的策略，在產品線方面取得了重要進展，獲得了重大批准，並成功推出了新產品。此外，我們在 10 月完成了對 Verona Pharma 的策略性收購。這為我們提供了一個重要的成長動力，在未來十年內具有數十億美元的商業潛力。

We're making strong progress across the business, and I remain confident in our ability to further broaden our impact to patients and deliver long-term growth and value for shareholders. With respect to US health care policy, as I've said before, we share the administration's goal of decreasing patient out-of-pocket costs for our products in the US while at the same time, realizing greater prices for our medicines and vaccines in countries that have not been paying fair value for the innovation we provide.

我們在整個業務領域都取得了強勁的進展，我對我們進一步擴大對患者的影響並為股東帶來長期增長和價值的能力仍然充滿信心。關於美國醫療保健政策，正如我之前所說，我們與政府的目標一致，即降低美國患者自付我們產品的費用，同時在那些沒有為我們提供創新產品支付合理價值的國家，實現我們藥品和疫苗的更高價格。

We're actively engaged with the administration in an effort to find a path forward that achieves these objectives. We also want to preserve our ability to invest in the breakthrough innovations we intend to bring to patients in the future while ensuring the sustainability of our business long term, and we're optimistic about our ability to do so.

我們正積極與政府溝通，努力尋找實現這些目標的前進道路。我們也希望保持投資能力，以便將來能為患者帶來突破性創新，同時確保業務的長期永續發展，我們對此充滿信心。

We continue to make significant investments in manufacturing in the United States. Last week, we announced a groundbreaking event at our Elkton, Virginia site as part of a broader plan that will result in the investment of more than $70 billion in expanded domestic manufacturing and R&D. These investments will support our plans to drive long-term growth and will strengthen the US as a global leader in biopharmaceutical innovation.

我們將繼續在美國製造業進行大量投資。上週，我們宣佈在維吉尼亞州埃爾克頓工廠舉行破土動工儀式，這是我們更廣泛計劃的一部分，該計劃將投資超過 700 億美元用於擴大國內製造業和研發。這些投資將支持我們推動長期成長的計劃，並將鞏固美國作為全球生物製藥創新領導者的地位。

Turning to our third quarter results. We're pleased to deliver solid performance, with continued strength across Oncology and Animal Health as well as increasing contributions from our new product launches, WINREVAIR, CAPVAXIVE, and most recently, ENFLONSIA.

接下來來看看我們第三季的業績。我們很高興能夠取得穩健的業績，在腫瘤學和動物保健領域持續保持強勁勢頭，同時，我們新產品 WINREVAIR、CAPVAXIVE 以及最近推出的 ENFLONSIA 也做出了越來越大的貢獻。

In research, several notable updates highlight our strong progress. In cardiovascular, we announced positive top line results from the CORALreef Lipids trial, the third and largest Phase 3 study evaluating enlicitide, our investigational oral PCSK9 inhibitor, in the treatment of hyperlipidemia. We look forward to sharing these results at the American Heart Association meeting next week and submitting these data to regulatory authorities.

在研究方面，幾項值得關注的更新突顯了我們取得的巨大進展。在心血管領域，我們發表了 CORALreef Lipids 試驗的積極初步結果，這是評估我們正在研究的口服 PCSK9 抑制劑 enlicitide 治療高血脂症的第三項也是規模最大的 3 期研究。我們期待在下週的美國心臟協會會議上分享這些結果，並將這些數據提交給監管機構。

In pulmonary arterial hypertension, full results from the HYPERION study in recently diagnosed patients reinforce our confidence in the practice-changing potential of WINREVAIR. Additionally, we secured FDA approval for our supplemental BLA for WINREVAIR based on the strong results of the ZENITH trial.

在肺動脈高壓方面，HYPERION 研究對近期確診患者的完整結果增強了我們對 WINREVAIR 改變實踐潛力的信心。此外，基於 ZENITH 試驗的強勁結果，我們獲得了 FDA 對 WINREVAIR 補充生物製品許可申請的批准。

In oncology, we're pleased that the FDA approved subcutaneous pembrolizumab, or KEYTRUDA QLEX, and that the CHMP granted a positive opinion. KEYTRUDA QLEX will provide patients and providers an important new option that can be injected in as little as one minute. We're working relentlessly to continue to develop and deliver new treatment options for patients with cancer. At ESMO, we presented data across a broad range of oncology medicines and candidates, including important findings from breakthrough therapy-designated ADCs.

在腫瘤學領域，我們很高興 FDA 批准了皮下注射帕博利珠單抗（KEYTRUDA QLEX），而 CHMP 也給予了正面評估。KEYTRUDA QLEX 將為患者和醫療服務提供者提供一個重要的全新選擇，注射過程只需短短一分鐘。我們正不懈努力，持續開發和提供新的癌症治療方案。在 ESMO 大會上，我們展示了涵蓋廣泛腫瘤藥物和候選藥物的數據，包括突破性療法指定 ADC 的重要發現。

Finally, we continue to expand our efforts in immunology, including for another of our important late-stage candidates, tulisokibart, where we initiated Phase 2b trials in three immune-mediated inflammatory diseases. These add to the Phase 2 study already underway in SSc-ILD and the ongoing Phase 3s in ulcerative colitis and Crohn's disease.

最後，我們繼續擴大在免疫學領域的努力，包括我們另一個重要的後期候選藥物 tulisokibart，我們已針對三種免疫介導的發炎性疾病啟動了 2b 期試驗。這些研究是對 SSc-ILD 正在進行的 2 期研究以及潰瘍性結腸炎和克羅恩病正在進行的 3 期研究的補充。

We're pleased to welcome our new colleagues from Verona Pharma and look forward to adding our commercial capabilities and scale to accelerate the launch of OHTUVAYRE, a novel, first-in-class maintenance treatment for chronic obstructive pulmonary disease. Strategic business development remains a top priority. We're assessing potential targets with urgency given our desire to make additional compelling investments when both science and value align.

我們很高興歡迎來自 Verona Pharma 的新同事，並期待利用我們的商業能力和規模加速推出 OHTUVAYRE，這是一種用於治療慢性阻塞性肺病的新型首創維持治療藥物。策略性業務發展仍是重中之重。鑑於我們希望在科學與價值相符的情況下進行更多引人注目的投資，我們正在緊急評估潛在目標。

In summary, we remain highly focused on building on the strong clinical and commercial progress we made in the quarter. The investments we're making to advance and expand our pipeline are increasingly translating into positive clinical results and successful new product launches. This is giving us improved line of sight towards the transformation of our portfolio to one with a far more diversified set of growth drivers.

總而言之，我們將繼續高度專注於鞏固本季在臨床和商業方面的強勁進展。我們為推進和擴展產品線所做的投資正日益轉化為積極的臨床結果和成功的新產品上市。這將使我們對投資組合轉型為擁有更多元化成長驅動因素的投資組合有更清晰的認識。

With each milestone we achieved, including compelling strategic business development, my conviction that we're well positioned to drive the next chapter of success for our company increases. I want to recognize the commitment and effort of our teams across the world. Together, I'm confident we'll achieve long-term growth and create sustainable value for both patients and shareholders.

隨著我們所取得的每一個里程碑，包括引人注目的策略性業務發展，我對我們已做好充分準備，推動公司邁向下一個成功篇章的信念也日益增強。我要表彰我們全球團隊的付出和努力。我相信，只要我們齊心協力，就能實現長期成長，並為患者和股東創造可持續的價值。

With that, I'll turn the call over to Caroline.

接下來，我將把電話交給卡羅琳。

Thank you, Rob. Good morning. As Rob noted, we delivered solid performance in the quarter, with growth driven by continued strength in Oncology and Animal Health as well as increasing contributions from our many new product launches. These results reinforce the conviction we have in our science-led strategy and in our outlook for continued growth.

謝謝你，羅布。早安.正如羅布所指出的，本季我們取得了穩健的業績，成長主要得益於腫瘤學和動物保健領域的持續強勁表現，以及眾多新產品上市帶來的貢獻不斷增加。這些結果更加堅定了我們對以科學為導向的策略以及對持續成長前景的信心。

We remain confident in our ability to deliver strong results in the near term and are committed to making disciplined investments in compelling science to drive long-term value for patients, customers and shareholders.

我們仍有信心在短期內取得優異的成績，並致力於對引人注目的科學進行審慎的投資，以創造長期價值，造福患者、客戶和股東。

Now turning to our third quarter results. Total company revenues were $17.3 billion, an increase of 4% or 3% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis. In oncology, sales of KEYTRUDA increased 8% to $8.1 billion, with global growth driven by strong demand from metastatic indications and robust uptake in earlier-stage cancers. Usage in tumors that primarily affects women, including cervical, breast, and endometrial cancers, was a key contributor to growth.

現在來看我們第三季的業績。公司總營收為 173 億美元，成長 4%，若不計匯率影響，則成長 3%。以下收入說明將以除息價格為基礎。在腫瘤領域，KEYTRUDA 的銷售額成長了 8%，達到 81 億美元，全球成長主要得益於轉移性適應症的強勁需求以及早期癌症的廣泛應用。該藥物在主要影響女性的腫瘤（包括子宮頸癌、乳癌和子宮內膜癌）的應用，是其成長的關鍵因素。

In addition, we saw increased use of KEYTRUDA in combination with Padcev in first-line, locally advanced or metastatic urothelial cancer. In the US, growth benefited by approximately $100 million from an extra Tuesday of shipments, partially offset by other channel movements. We are also excited by the recent FDA approval and launch of KEYTRUDA QLEX, which occurred at the end of the quarter.

此外，我們也看到 KEYTRUDA 與 Padcev 合併用於第一線治療局部晚期或轉移性尿路上皮癌的情況增加。在美國，由於週二額外增加了一次出貨量，成長受益約 1 億美元，但部分被其他管道的變動所抵消。我們也對 KEYTRUDA QLEX 近期獲得 FDA 批准並上市感到興奮，這項批准和上市發生在本季結束時。

Our broader oncology portfolio achieved another quarter of strong growth, driven by WELIREG with sales increasing 41% to $196 million, predominantly driven by increased use in certain patients with previously treated advanced renal cell carcinoma in the US as well as continued uptake from ongoing launches in certain international markets.

我們更廣泛的腫瘤產品組合又實現了強勁增長，其中 WELIREG 的銷售額增長了 41%，達到 1.96 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量增加，以及某些國際市場持續推出該產品帶來的持續增長。

In vaccines, GARDASIL sales were $1.7 billion, a decrease of 25%. Excluding China, sales declined 3%, primarily due to lower sales in Japan, reflecting the expiration of reimbursement for the catch-up cohort, partially offset by sales growth of 13% in the US which was attributable to price and CDC purchasing patterns.

在疫苗方面，加衛苗的銷售額為 17 億美元，下降了 25%。除中國外，銷售額下降了 3%，主要原因是日本銷售額下降，反映出補種疫苗的報銷到期，部分被美國 13% 的銷售額增長所抵消，這主要歸因於價格和美國疾病控制與預防中心的採購模式。

In pneumococcal, CAPVAXIVE sales were $244 million, driven by demand from both retail pharmacies and non-retail customers as well as the expected seasonal inventory build. We look forward to helping protect more adults from invasive pneumococcal disease and to driving continued growth of this important product.

在肺炎球菌方面，CAPVAXIVE 的銷售額為 2.44 億美元，這得益於零售藥局和非零售客戶的需求，以及預期的季節性庫存增加。我們期待幫助更多成年人免受侵襲性肺炎球菌疾病的侵害，並推動這項重要產品的持續成長。

VAXNEUVANCE sales decreased 7% due to a competitive preferential recommendation in Japan, which more than offset growth in certain international markets. In the US, sales were roughly flat as competitive pressures were largely offset by favorable CDC stockpile activity. In RSV, ENFLONSIA sales of $79 million reflects initial stocking ahead of expected demand. We look forward to helping protect infants born during or entering their first RSV season.

由於日本市場競爭激烈，VAXNEUVANCE 的銷售額下降了 7%，抵消了某些國際市場的成長。在美國，由於美國疾病管制與預防中心的儲備活動有利於緩解競爭壓力，銷售額基本上持平。RSV 中 ENFLONSIA 的銷售額為 7,900 萬美元，反映了在預期需求之前進行的初步庫存。我們期待著幫助保護在 RSV 流行季期間出生或即將進入第一個流行季的嬰兒。

In cardiovascular, WINREVAIR continued its strong momentum with global sales of $360 million. In the US, approximately 1,500 new patients received the prescription and over 24,000 total prescriptions were dispensed in the quarter, a testament to the continued strong demand for this important treatment option. There was also an approximate $40 million negative impact from the timing of distributor purchases, which fully reversed in October.

在心血管領域，溫瑞華持續保持強勁的成長勢頭，全球銷售額達 3.6 億美元。在美國，大約有 1500 名新患者獲得了處方，該季度共發放了超過 24000 張處方，證明了人們對這種重要治療方案的持續強勁需求。經銷商採購的時間安排也造成了約 4000 萬美元的負面影響，但這種情況在 10 月完全逆轉。

Compelling additional data from ongoing studies, which Dean will speak to in a moment, further support our outlook for steady new patient starts. Over time, we expect an increasing proportion of use in patients whose background therapies do not include a prostacyclin.

迪恩稍後將談到，正在進行的研究提供的更多令人信服的數據進一步支持了我們對穩定新增患者數量的期望。隨著時間的推移，我們預期在背景治療方案中不包括前列環素的患者中，使用比例會越來越高。

Outside the US, we continue to make progress with securing approvals and reimbursement, including the recent launch in Japan, which is off to a good start. Overall, we look forward to positively impacting the lives of more patients with PAH.

在美國以外，我們在獲得批准和報銷方面繼續取得進展，包括最近在日本的上市，目前進展順利。總而言之，我們期待對更多 PAH 患者的生活產生正面影響。

Our Animal Health business again delivered strong growth, with sales increasing 7%. Livestock sales grew 14%, driven by higher demand across all species as well as a benefit from timing of sales. Companion animal sales declined 3% due to a reduction in vet visits and competition in parasiticides, partially offset by price, improved supply and new product launches.

我們的動物保健業務再次實現強勁成長，銷售額成長了 7%。牲畜銷售額成長了 14%，這主要得益於所有品種需求的成長以及銷售時機的有利因素。由於獸醫就診次數減少和殺蟲劑市場競爭加劇，伴侶動物銷售額下降了 3%，但價格上漲、供應改善和新產品上市在一定程度上抵消了這一影響。

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 81.9%, an increase of 1.4 percentage points driven by favorable product mix. Operating expenses decreased to $6.6 billion. There were $300 million in business development charges in the quarter, compared with $2.2 billion in charges a year ago.

接下來，我將帶您了解我們損益表的剩餘部分，我的評論將以非GAAP準則為基礎。毛利率為 81.9%，較前一年成長 1.4 個百分點，主要得益於有利的產品組合。營運支出減少至66億美元。本季業務發展費用為 3 億美元，去年同期為 22 億美元。

Excluding these charges, operating expenses were flat, reflecting an increase in investments in support of our robust early- and late-phase pipeline as well as key growth drivers, offset by the timing of expenses. Other expense was $106 million. Our tax rate of 13.4% benefited from certain discrete items. Taken together, earnings per share were $2.58.

除這些費用外，營運支出持平，這反映出我們為支持強大的早期和後期研發管線以及關鍵成長驅動因素而增加的投資，但被支出的時間安排所抵消。其他支出為1.06億美元。我們的稅率為 13.4%，這得益於某些特定項目。合計，每股收益為 2.58 美元。

Now turning to our 2025 non-GAAP guidance, which now includes the acquisition of Verona Pharma, as well as the restructured agreement for Koselugo. We expect full year revenue to be between $64.5 billion and $65 billion. This range represents growth of 1% to 2%, excluding a negative impact from foreign exchange of approximately 0.5% using mid-October rates.

現在轉向我們的 2025 年非 GAAP 指引，其中現在包括對 Verona Pharma 的收購，以及對 Koselugo 的重組協議。我們預計全年營收將在 645 億美元至 650 億美元之間。此區間代表 1% 至 2% 的成長，不包括使用 10 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%, including an updated estimate of less than $100 million in costs related to the impact of tariffs. Operating expenses are now assumed to be between $25.9 billion and $26.4 billion. This guidance does not assume additional significant potential business development transactions. Other expense is now expected to be between $400 million and $500 million. We now assume a full year tax rate between 14% and 15%. We assume approximately 2.51 billion shares outstanding.

我們的毛利率假設仍約為 82%，其中包括與關稅影響相關的成本更新估計值不到 1 億美元。目前預計營運費用在 259 億美元至 264 億美元之間。本指南不假設存在其他重大的潛在業務發展交易。其他支出預計在 4 億美元至 5 億美元之間。我們現在假設全年稅率在 14% 到 15% 之間。我們假設流通股約為 25.1 億股。

Taken together, our EPS guidance is $8.93 to $8.98. Relative to 2024, this range includes a negative impact from foreign exchange of approximately $0.15, using mid-October rates. Recall, our prior guidance midpoint was $8.92. Our current guidance midpoint of $8.96 reflects a benefit from the restructured agreement for Koselugo of $0.09, partially offset by an estimated negative impact related to the acquisition of Verona of $0.04.

綜合來看，我們的每股盈餘預期為 8.93 美元至 8.98 美元。與 2024 年相比，該範圍包含了約 0.15 美元的匯率負面影響（以 10 月中旬的匯率計算）。回顧一下，我們之前的指導中位數為 8.92 美元。我們目前的指導中位數為 8.96 美元，這反映了 Koselugo 重組協議帶來的 0.09 美元收益，但部分被收購 Verona 帶來的 0.04 美元的預期負面影響所抵消。

As you consider your models, there are a few items to keep in mind. For KEYTRUDA, as previously communicated, year-over-year growth in the US in the fourth quarter is expected to be negatively impacted by approximately $200 million due to the timing of wholesaler purchases. For ENFLONSIA, we are pleased with the initial purchases in the US. Keep in mind that most of this was stocking ahead of expected usage in this RSV season.

在考慮模型時，有幾點需要注意。正如之前所溝通的那樣，由於批發商採購的時間安排，KEYTRUDA在美國第四季度的同比增幅預計將受到約2億美元的負面影響。對於 ENFLONSIA，我們對在美國的初步採購感到滿意。請注意，這大部分是為了應對本呼吸道合胞病毒（RSV）流行季的預期使用量而提前儲備的。

Lastly, as Rob noted, we have one of the most robust pipelines in our recent history. Importantly, all of our major programs are advancing and we are excited about the additional opportunities in front of us. As we have said before, we intend to fully invest behind these opportunities, and as we look to 2026, we expect an acceleration in underlying operating expense growth driven by investments in both R&D and SG&A to fuel our pipeline and new launches, including more than $0.5 billion of investment to maximize the potential of OHTUVAYRE. This will enable us to continue to bring forward innovative medicines and vaccines to make a difference in the lives of patients and drive growth for our company.

最後，正如羅布所指出的那樣，我們擁有近年來最強大的管道系統之一。重要的是，我們所有主要項目都在順利推進，我們對面前更多的機會感到興奮。正如我們先前所說，我們打算全力投資這些機會，展望 2026 年，我們預計研發和銷售、一般及行政費用方面的投資將推動基本營運支出成長加速，以推動我們的產品線和新產品上市，其中包括超過 5 億美元的投資，以最大限度地發揮 OHTUVAYRE 的潛力。這將使我們能夠繼續推出創新藥物和疫苗，從而改善患者的生活，並推動公司的發展。

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 key growth drivers and expansive pipeline of novel candidates, each of which has significant potential to address important unmet medical needs.

現在來說說資本配置，我們的策略維持不變。我們將優先投資於公司業務，以推動近期和長期成長。我們將繼續投資於我們的關鍵成長驅動因素和廣泛的新候選藥物研發管線，每種藥物都具有解決重要未滿足醫療需求的巨大潛力。

We remain committed to our dividend with the goal of increasing it over time. Business development remains a high priority, and we are well positioned to pursue additional science-driven value-enhancing transactions. We are maintaining our increased pace of share repurchases and expect approximately $5 billion for the full year.

我們將繼續致力於派發股息，並計劃隨著時間的推移逐步提高股息水準。業務發展仍然是我們的首要任務，我們已做好充分準備，尋求更多以科學為導向的價值提升交易。我們將繼續加快股票回購步伐，預計全年回購金額約 50 億美元。

To conclude, as we finish the year, we are confident in the outlook of our business driven by global demand for our innovative in-line portfolio, the exciting progress we are seeing with our many product launches and our exceptional pipeline. With continued investment in innovation and our ongoing focus on execution, we remain well positioned to deliver value to patients, customers and shareholders now and well into the future.

總之，在年末之際，我們對公司業務前景充滿信心，這得益於全球對我們創新線上產品組合的需求、眾多產品發布所取得的令人振奮的進展以及我們卓越的產品線。透過持續投資創新和持續專注於執行，我們仍然能夠為患者、客戶和股東創造價值，無論現在或未來。

With that, I'd now like to turn the call over to Dean.

那麼，我現在想把電話交給迪恩。

Thank you, Caroline. Good morning, everyone. The third quarter was marked by several notable clinical and regulatory milestones. I will start with updates in oncology, followed by vaccines and infectious disease, immunology, ophthalmology, and then cover advancements in our cardiovascular and pulmonary programs. I will close by highlighting key upcoming events through the first half of 2026.

謝謝你，卡洛琳。各位早安。第三季取得了多項重要的臨床和監管里程碑。我將首先介紹腫瘤學的最新進展，然後是疫苗和傳染病、免疫學、眼科科學，最後介紹我們在心血管和肺部疾病方面的進展。最後，我將重點介紹 2026 年上半年即將發生的一些重要事件。

Progress continues across our diverse oncology portfolio. Last month, we received FDA approval for KEYTRUDA QLEX injection for subcutaneous administration of pembrolizumab. KEYTRUDA QLEX offers a substantially quicker administration time than intravenous infusion of KEYTRUDA, and can be administered subcutaneously by a health care provider in as little as one minute when given every 3 weeks. It has the potential to provide flexibility in the site of care while helping to increase efficiency in and access to health care systems. We also see opportunity for use in certain patients with earlier stage disease.

我們在多元化的腫瘤產品組合中持續取得進展。上個月，我們獲得了 FDA 批准，KEYTRUDA QLEX 注射液可用於皮下注射帕博利珠單抗。與靜脈輸注 KEYTRUDA 相比，KEYTRUDA QLEX 的給藥時間大大縮短，醫護人員每 3 週皮下注射一次，最快只需 1 分鐘。它有可能在護理地點方面提供靈活性，同時有助於提高醫療保健系統的效率和可及性。我們也看到了這種療法對某些早期患者的潛在應用價值。

To date, KEYTRUDA-based regimens have received FDA approval for 10 indications in the earlier setting. Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use granted a positive opinion for subcutaneous administration of KEYTRUDA. The European Commission has approved KEYTRUDA as part of a perioperative regimen for the treatment of certain adult patients with resectable, locally advanced head and neck squamous cell carcinoma based on the Phase 3 KEYNOTE-689 trial.

迄今為止，基於 KEYTRUDA 的治療方案已獲得 FDA 批准用於 10 種早期適應症。上個月，歐洲藥品管理局人用藥品委員會對皮下注射 KEYTRUDA 給予了正面意見。根據 KEYNOTE-689 3 期試驗，歐盟委員會已批准 KEYTRUDA 作為圍手術期治療方案的一部分，用於治療某些可切除的局部晚期頭頸部鱗狀細胞癌成年患者。

We continue to build upon the extensive body of evidence for KEYTRUDA in multiple indications spanning both earlier and metastatic stages of disease. At the European Society for Medical Oncology Congress, data from the KEYTRUDA program were showcased in two Presidential Symposium sessions. These include progression-free and overall survival results from KEYNOTE-B96 in certain patients with platinum-resistant recurrent ovarian cancer. The FDA has accepted our sBLA for priority review and set a PDUFA date of February 20.

我們不斷累積大量證據，證明 KEYTRUDA 在多種適應症中均有效，涵蓋疾病的早期和轉移階段。在歐洲腫瘤內科學會大會上，KEYTRUDA 計畫的數據在兩場主席專題研討會上進行了展示。其中包括 KEYNOTE-B96 研究中某些鉑金抗藥性復發性卵巢癌患者的無惡化存活期和總存活期結果。FDA 已接受我們的 sBLA 進行優先審查，並將 PDUFA 日期定為 2 月 20 日。

Also at ESMO, event-free and overall survival data from KEYNOTE-905 in patients with muscle-invasive bladder cancer who were ineligible for cisplatin-based chemotherapy, conducted in collaboration with Astellas and Pfizer, were presented. The FDA has also accepted this sBLA for priority review with a PDUFA date of April 7.

在 ESMO 會議上，也發表了與安斯泰來和輝瑞合作開展的 KEYNOTE-905 研究的無事件生存期和總生存期數據，該研究針對的是不適合接受順鉑化療的肌層浸潤性膀胱癌患者。FDA 也已接受該 sBLA 進行優先審查，PDUFA 日期為 4 月 7 日。

The success of KEYTRUDA has enabled us to build a diversified oncology pipeline. At ESMO, data from our growing portfolio of antibody drug conjugate candidates were also presented, including: results for sac-TMT, our TROP2 targeting ADC, from the Phase 3 OptiTROP-Lung04 study in patients with EGFR-mutated non-small cell lung cancer conducted by our collaborator, Kelun.

KEYTRUDA 的成功使我們能夠建立多元化的腫瘤產品線。在 ESMO 上，我們也展示了不斷增長的抗體藥物偶聯物候選藥物組合的數據，其中包括：我們的 TROP2 靶向 ADC 藥物 sac-TMT 的結果，該結果來自我們的合作者 Kelun 開展的針對 EGFR 突變型非小細胞肺癌患者的 3 期 OptiTROP-Lung04 研究。

Findings from Kelun's Phase 3 OptiTROP-Breast02 study evaluating sac-TMT in locally advanced or metastatic HR-positive, HER2-negative breast cancer, as well as results from the Phase 2/3 REJOICE-Ovarian01 study evaluating R-DXd, our CDH6 targeting ADC, in certain patients with platinum-resistant ovarian, primary peritoneal or fallopian tube cancer in collaboration with Daiichi Sankyo.

科倫製藥的 3 期 OptiTROP-Breast02 研究評估了 sac-TMT 在局部晚期或轉移性 HR 陽性、HER2 陰性乳腺癌中的療效，以及與第一三共製藥合作開展的 2/3 期 REJOICE-Ovarian01 研究評估了 R-DXd（我們的 CDH6 標靶 ADC）在細胞內對卵巢的耐藥性免疫活性。

Also, earlier this week, we were pleased to announce positive results for WELIREG, our first-in-class oral HIF-2 alpha inhibitor, across adjuvant and advanced renal cell carcinoma based on 2 Phase 3 trials: LITESPARK-022 in combination with KEYTRUDA, and LITESPARK-011 in combination with Lenvima in collaboration with Eisai.

此外，本週早些時候，我們很高興地宣布，基於兩項 3 期試驗，我們的首創口服 HIF-2 α 抑制劑 WELIREG 在輔助治療和晚期腎細胞癌方面取得了積極結果：LITESPARK-022 與 KEYTRUDA 聯合治療，以及 LITESPARK-011 與 Lenvima 聯合治療（與 Eisai 合作）。

Next, to vaccines and infectious disease. Starting with CAPVAXIVE, our 21 valent pneumococcal conjugate vaccine. Following the approval in the US and EU, in August, the Japanese Ministry of Health, Labor and Welfare granted approval for CAPVAXIVE for the prevention of pneumococcal infections in the elderly and adults at high risk. We are also evaluating the potential of CAPVAXIVE in additional patient types.

接下來是疫苗和傳染病。首先是 CAPVAXIVE，我們的 21 價肺炎鏈球菌結合疫苗。美國和歐盟批准後，日本厚生勞動省於 8 月批准 CAPVAXIVE 用於預防老年人和高風險成年人的肺炎球菌感染。我們也正在評估 CAPVAXIVE 在其他患者類型中的應用潛力。

At the European Society of Clinical Microbiology and Infectious Diseases Conference on vaccines, results of the Phase 3 STRIDE-13 trial, examining the safety, tolerability and immunogenicity in children and adolescents aged 2 to 17 years who are at increased risk of pneumococcal disease were presented. The FDA has accepted for review the sBLA and set a PDUFA date of June 18.

在歐洲臨床微生物學和傳染病學會疫苗會議上，發表了 STRIDE-13 3 期試驗的結果，該試驗旨在檢驗 2 至 17 歲患肺炎球菌疾病風險較高的兒童和青少年的安全性、耐受性和免疫原性。FDA 已受理該補充生物製品許可申請 (sBLA) 的審查，並將處方藥使用者付費法案 (PDUFA) 的審查日期定為 6 月 18 日。

Regarding RSV, following approval in June, ENFLONSIA, our long-acting monoclonal antibody for the prevention of RSV disease in infants entering or during their first RSV season is now available. Earlier this month, we received a positive CHMP opinion from the European Medicines Agency.

關於 RSV，繼 6 月獲得批准後，我們的長效單株抗體 ENFLONSIA 現已上市，用於預防嬰兒在進入或經歷第一個 RSV 流行季時感染 RSV 的疾病。本月初，我們收到了歐洲藥品管理局人用藥品委員會的積極意見。

Turning to HIV. We have development programs spanning both treatment and PrEP settings anchored by our investigational NRTTIs islatravir and MK-8527. Earlier this month, new findings were presented at the European AIDS Conference including: 48-week Phase 3 data for doravirine and islatravir as a once-daily, oral 2-drug regimen for the treatment of adults with virologically suppressed HIV-1 infection on antiretroviral therapy; and 96-week Phase 2 outcomes data for the investigation of once-weekly oral combination of islatravir with lenacapavir for adults with virologically suppressed HIV-1 infection, in collaboration with Gilead.

轉向愛滋病。我們擁有涵蓋治療和 PrEP 領域的研發項目，這些項目以我們正在研究的 NRTTI 藥物 islatravir 和 MK-8527 為核心。本月初，歐洲愛滋病大會上公佈了新的研究結果，其中包括：多拉韋林和伊斯拉曲韋作為每日一次口服雙藥方案治療接受抗逆轉錄病毒治療且病毒學上受到抑制的 HIV-1 感染成人的 48 週 3 期數據；以及與吉利德合作開展的，伊斯拉曲韋與來那卡帕韋 每週上一次感染病毒治療-96 週的成人組合的 196 週上一次。

Moving to immunology, then ophthalmology. Tulisokibart is a humanized monoclonal antibody that targets tumor necrosis factor like cytokine 1A, that is associated with inflammation and fibrosis. The Phase 3 ATLAS trial in ulcerative colitis recently completed enrollment, and the Phase 3 ARES trial in Crohn's disease remains on track. Building on these studies, we recently announced an expansion of the development program evaluating tulisokibart in dermatology and rheumatology indications with the initiation of 3 Phase 2b trials.

轉學免疫學，然後是眼科學。Tulisokibart 是一種人源化單株抗體，靶向腫瘤壞死因子，如細胞因子 1A，與發炎和纖維化有關。潰瘍性結腸炎的 3 期 ATLAS 試驗最近完成了入組，克羅恩病的 3 期 ARES 試驗仍在按計劃進行。基於這些研究，我們最近宣布擴大開發計劃，評估 tulisokibart 在皮膚病學和風濕病學適應症中的療效，並啟動 3 項 2b 期試驗。

Since the acquisition of EyeBio last year, we have made significant progress advancing the Phase 3 clinical development program for MK-3000. Our novel candidate targeting the Wnt pathways for certain retinal diseases. Enrollment in the Phase 3 BRUNELLO study in patients with diabetic macular edema is complete and the study's primary completion date has been accelerated to September 2026. SUPER TUSCAN, a Phase 2 study evaluating MK-3000 in patients with neovascular age-related macular degeneration as well as retinal vein occlusion is currently enrolling.

自去年收購 EyeBio 以來，我們在推動 MK-3000 的 3 期臨床開發專案方面取得了重大進展。我們針對某些視網膜疾病，提出了一種針對 Wnt 路徑的新型候選藥物。針對糖尿病性黃斑水腫患者的 3 期 BRUNELLO 研究的入組工作已經完成，該研究的主要完成日期已提前至 2026 年 9 月。SUPER TUSCAN 是一項 2 期研究，旨在評估 MK-3000 對新生血管性老年黃斑部病變以及視網膜靜脈阻塞患者的療效，目前正在招募患者。

In addition, earlier this month, at the Eyecelerator event hosted by the American Academy of Ophthalmology, we presented promising first-time Phase 1 data from the RIOJA study evaluating MK-8748, our tetravalent bi-specific antibody targeting Tie2 and VEGF, in patients with macular edema secondary to branch retinal vein occlusion and neovascular age-related macular degeneration. Based on these data, we plan to initiate late-stage trials in 2026.

此外，本月初，在美國眼科學會主辦的 Eyecelerator 活動上，我們展示了 RIOJA 研究的初步 1 期數據，該研究評估了 MK-8748（一種靶向 Tie2 和 VEGF 的四價雙特異性抗體）在治療分支視網膜靜脈阻塞和新生血管性老年黃斑水腫性繼發性黃斑水腫患者中的療效。根據這些數據，我們計劃於 2026 年啟動後期試驗。

Next, to our cardiovascular and pulmonary programs. WINREVAIR, the first and only activin signaling inhibitor for the treatment of adults with pulmonary arterial hypertension, continues to generate evidence for benefit across a broad spectrum of patients with PAH.

接下來是我們的心血管和肺部疾病計畫。WINREVAIR 是第一個也是目前唯一用於治療成人肺動脈高壓的激活素訊號抑制劑，它不斷產生證據，證明其對廣泛的 PAH 患者有益。

Results from the Phase 3 HYPERION trial in recently diagnosed adults with PAH were presented at the European Respiratory Society meeting. Adding WINREVAIR on top of background therapy showed a significant 76% reduction in risk of clinical worsening events compared to background therapy alone, despite early termination of the study due to loss of clinical equipoise. The findings were also published in the New England Journal of Medicine.

在歐洲呼吸學會會議上，發表了針對近期確診的 PAH 成年患者的 3 期 HYPERION 試驗結果。儘管由於臨床平衡性喪失而提前終止了研究，但在背景治療的基礎上添加 WINREVAIR 與單獨進行背景治療相比，臨床惡化事件的風險顯著降低了 76%。研究結果也發表在《新英格蘭醫學雜誌》。

The FDA also recently approved an update to the WINREVAIR product label based on the results of the Phase 3 ZENITH trial. With the expanded indication, WINREVAIR is the first PAH therapy to have an indication that includes components of the clinical worsening event, hospitalization for PAH, lung transplantation and death.

根據 3 期 ZENITH 試驗的結果，FDA 最近也批准了 WINREVAIR 產品標籤的更新。隨著適應症的擴大，WINREVAIR 成為首個適應症包括臨床惡化事件、PAH 住院、肺移植和死亡等因素的 PAH 治療藥物。

With the closing of the Verona Pharma acquisition, we welcomed new colleagues to the team. Together, we are well positioned to build upon the success of OHTUVAYRE, a first-in-class dual phosphodiesterase 3 and 4 inhibitor for the maintenance treatment of chronic obstructive pulmonary disease. We plan to advance the ongoing work in bronchiectasis and evaluate utility in additional indications, combination therapies and alternative formulations. Despite advances in the screening and treatment, there continues to be a cardiovascular disease epidemic with ASCVD as the leading cause of death globally.

隨著對 Verona Pharma 的收購完成，我們迎來了新的同事加入團隊。我們攜手並進，完全有能力在 OHTUVAYRE 的成功基礎上再創佳績。 OHTUVAYRE 是第一個用於慢性阻塞性肺病維持治療的雙重磷酸二酯酶 3 和 4 抑制劑。我們計劃推進支氣管擴張症的現有研究，並評估其在其他適應症、聯合療法和替代製劑中的應用價值。儘管篩檢和治療方面取得了進展，心血管疾病仍然流行，動脈粥狀硬化性心血管疾病 (ASCVD) 仍然是全球首要死因。

In September, we announced that enlicitide, our investigational oral PCSK9 inhibitor, met all primary and key secondary end points in the CORALreef Lipids study, demonstrating statistically significant and clinically meaningful reduction in LDL cholesterol for the treatment of adults with hypercholesterolemia on a moderate or high-intensity statin or with documented statin intolerance.

9 月，我們宣布，我們的在研口服 PCSK9 抑制劑 enlicitide 在 CORALreef Lipids 研究中達到了所有主要和關鍵次要終點，證明其在治療服用中等或高強度他汀類藥物或有記錄的他汀類藥物不耐受的高膽固醇血症成年患者時，可顯著降低 LDL 水平，具有統計學意義和臨床意義。

This is the third positive Phase 3 trial for enlicitide. We look forward to presenting the detailed results of the CORALreef Lipid study as well as the CORALreef study focused on familial heterozygous hypercholesterolemia at the American Heart Association Scientific Sessions meeting next week in New Orleans.

這是恩利西肽的第三項積極的3期臨床試驗結果。我們期待在下週於新奧爾良舉行的美國心臟協會科學會議上，發表 CORALreef 脂質研究的詳細結果以及 CORALreef 針對家族性雜合子高膽固醇血症的研究結果。

Please mark your calendars for an investor event at AHA on the evening of Sunday, November 9, where we will highlight these results and provide an overview of our cardiovascular and pulmonary program. We continue to see strong momentum across the pipeline. As Rob noted, there are approximately 80 Phase 3 trials underway across multiple therapeutic areas. We have initiated more than 15 Phase 3 trials this year and expect to have an increasing number in 2026.

請在日曆上標記 11 月 9 日星期日晚上 AHA 的投資者活動，屆時我們將重點介紹這些結果，並概述我們的心血管和肺部項目。我們看到整個產品線持續保持強勁的成長勢頭。正如羅布所指出的，目前在多個治療領域約有 80 項 3 期臨床試驗正在進行中。今年我們已經啟動了超過 15 項 3 期臨床試驗，預計 2026 年試驗數量將會增加。

As we look through the first half of 2026, we anticipate a regular cadence of milestones across therapeutic areas, including: in oncology, the February 20 PDUFA date for certain patients with platinum-resistant recurrent ovarian cancer based on KEYNOTE-B96; the April 7 PDUFA date for certain patients with earlier-stage MIBC based on KEYNOTE-905.

展望 2026 年上半年，我們預計各個治療領域將有規律地取得里程碑式的進展，包括：在腫瘤學領域，基於 KEYNOTE-B96 研究，某些鉑耐藥復發性卵巢癌患者的 PDUFA 日期為 2 月 20 日；基於 KEYNOTE-905 研究，某些早期 MIBC 患者的 PDUFA 日期為 4 月 7 日早期。

In HIV: the April 28 PDUFA date for the combination of doravirine and islatravir, an oral once-daily treatment regimen; and data from the Phase 3 ISLEND-1 and 2 trials evaluating islatravir in combination with lenacapavir, as a once-weekly oral treatment regimen.

在 HIV 領域：多拉韋林和伊斯拉曲韋的組合（每日一次口服治療方案）的 PDUFA 日期為 4 月 28 日；以及評估伊斯拉曲韋與來那卡帕韋聯合使用（每週一次口服治療方案）的 3 期 ISLEND-1 和 2 試驗的數據。

In immunology: Phase 2 data for tulisokibart from the ATHENA study in SSc-ILD; in cardiopulmonary: for WINREVAIR, data from the Phase 2 CADENCE study in pulmonary hypertension due to left heart disease; for enlicitide: presentation of detailed results from 3 Phase 3 trials from the CORALreef development program.

在免疫學領域：來自 ATHENA 研究的 tulisokibart 在 SSc-ILD 中的 2 期數據；在心肺領域：來自 CADENCE 研究的 WINREVAIR 在左心疾病引起的肺動脈高壓中的 2 期數據；對於 enlicitide：來自 CORALreef 開發計劃的 3 項 3 期試驗的詳細結果。

We continue to make progress with a diversified pipeline across multiple therapeutic areas, and I look forward to providing further updates on our programs in 2026.

我們在多個治療領域擁有多元化的產品線，並持續取得進展，我期待在 2026 年向我們提供更多關於我們計畫的最新資訊。

And now I turn the call back to Peter.

現在我把電話轉回給彼得。

Thank you, Dean. Julie, we're now ready for Q&A. (Event Instructions)

謝謝你，院長。朱莉，現在進入問答環節。（活動須知）

(Operator Instructions) Asad Haider, Goldman Sachs.

（操作說明）阿薩德·海德爾，高盛。

Great, thanks for taking the question. Maybe for Rob on BD. I was reassured to hear in the prepared remarks that you are assessing potential targets with urgency. And certainly, your Verona deal seems well received, and it seems that the market wants to see more of those types of transactions from you. So I guess any updated framing on what you're looking for would be helpful.

太好了，謝謝你回答這個問題。或許是為了羅布的BD。我從事先準備好的演講稿中得知，你們正在緊急評估潛在目標，這讓我感到很欣慰。當然，您在維羅納的交易似乎很受歡迎，市場似乎也希望看到您進行更多此類交易。所以，我想任何關於你正在尋找什麼的最新描述都會有所幫助。

And then related, there's also been an ongoing pickup in discussions about the potential reemergence of potentially transformative larger transactions in the industry, just given the external environment. So curious if you could share your updated views there. Thank you.

此外，鑑於外部環境，業界關於可能再次出現具有變革意義的大型交易的討論也持續升溫。很想知道您是否可以分享您最新的看法。謝謝。

Great. Asad, thanks for the question. As it relates to business development, as you point out, we were very excited about getting the closure of the deal with Verona. And as you know, we continue to see OHTUVAYRE as a multibillion-dollar opportunity. So excited about that. But as we've also said, we're not done, we do need to do more.

偉大的。阿薩德，謝謝你的提問。就業務發展而言，正如您所指出的，我們對與維羅納達成交易感到非常興奮。如您所知，我們仍然認為 OHTUVAYRE 是一個價值數十億美元的商機。對此我感到非常興奮。但正如我們之前所說，我們還沒有完成，我們還需要做更多的工作。

We continue to look across all therapeutic areas. I would say, obviously, the areas of focus for us continue to be aligned with what is our key therapeutic areas from the business perspective. Oncology continues to see a lot of opportunities, immunology, cardiometabolic and the like are where we're continuing to focus. As is always the case, science will drive us. And when we see a scientific opportunity where there's an unmet need that we think strategically aligns with our approach, if we see value, we'll move. So no change in our approach.

我們將繼續關注所有治療領域。顯然，從業務角度來看，我們的重點領域仍然與我們的關鍵治療領域保持一致。腫瘤學領域仍有許多機會，免疫學、心血管代謝等領域是我們將持續關注的重點。一如既往，科學將指引我們前進。當我們發現某個科學機會，存在著尚未滿足的需求，並且我們認為該機會在策略上與我們的方法相符時，如果我們認為它有價值，我們就會採取行動。因此，我們的方法不會改變。

And as you think about deal size, we continue to be focused in that $1 billion to $15 billion range as the primary area. But as we've been clear to say in the past, we are willing to go larger than that, but always with the focus on science and always understanding that if we look and see an opportunity, we're going to do it based on that unmet need.

至於交易規模，我們仍主要關注 10 億美元至 150 億美元的區間。但正如我們過去一直明確表示的那樣，我們願意做得更大，但始終以科學為中心，並且始終明白，如果我們發現機會，我們就會根據尚未滿足的需求去做。

As you think forward to your broader question on the reemergence of potential larger scale deals, our view of that has not changed. We do not think that a transformative acquisition, a synergy-driven deal is something that we need to do nor aligns with our future because as you know, we have one of the most robust pipelines we've ever had, and we see large synergy-driven deals as disruptive to that activity. And so our focus will be on bringing in pipeline assets not on those types of deals. But as you think about that, as we've said in the past, we're open to Phase I all the way through Phase III, and where we can find it, commercial opportunities. So we look across the full spectrum.

至於您提出的關於潛在的更大規模交易是否會再次出現這個更廣泛的問題，我們對此的看法並沒有改變。我們認為，我們不需要進行變革性收購，也不需要進行協同效應驅動的交易，因為這與我們的未來發展不符，因為正如您所知，我們擁有有史以來最強大的項目儲備之一，我們認為大型協同效應驅動的交易會破壞這一發展。因此，我們的重點將放在引進管道資產上，而不是那些類型的交易。但正如我們過去所說，我們對從第一階段到第三階段的所有階段都持開放態度，並會盡可能尋找商業機會。所以我們要從各方面來考察。

Geoff Meacham, Citibank.

傑夫‧米查姆，花旗銀行。

Great. Morning, everyone. Thanks for the question. I had a pipeline one for Dean. So on the expanding development of your TLL1 immunology, I'm assuming that a broad development program was already in place surrounding the Prometheus deal. But maybe talk about the selection of the indications that you just announced from a mechanism perspective and maybe what additional development opportunities do you like across the I&I space. Thank you.

偉大的。大家早安。謝謝你的提問。我給迪恩安排了一個管道。因此，關於您不斷擴展的 TLL1 免疫學研究，我假設圍繞 Prometheus 交易已經制定了一項廣泛的開發計劃。但或許可以從機制的角度談談您剛剛宣布的適應症的選擇，以及您在免疫和免疫領域還有哪些其他的發展機會。謝謝。

Yes. Thank you very much for the question. I mean the focus initially was in the GI space, and we're -- our ambition is to be the first and best-in-class TL1A. We've always talked about that expansion. We've always thought about that expansion, and that expansion has been recently sort of outlined with recent Phase 2b studies in rheumatology and dermatology.

是的。非常感謝您的提問。我的意思是，最初的重點是胃腸道領域，我們的目標是成為第一家也是最好的TL1A公司。我們一直在討論擴張的問題。我們一直在考慮這種擴張，而最近在風濕病學和皮膚病學領域開展的 2b 期研究也大致勾勒出了這種擴張的輪廓。

The question is, could we see more? I will always leave that open. I do think that the Phase III for ulcerative colitis and especially for Crohn's disease is very important to me, not just because it's in GI, but in Crohn's, there's an element of fibrosis.

問題是，我們是否還能看到更多？我會一直保留這種可能性。我認為潰瘍性結腸炎，尤其是克隆氏症的 III 期臨床試驗對我來說非常重要，不僅因為它是胃腸道疾病，還因為克隆氏症存在纖維化因素。

And the other one is the Phase 2 in SSc-ILD. I will need to see that because if I see that in Crohn's disease, then you all of a sudden start talking about not just similar to other anti-cytokines, dampening down inflammation, you then have a leverage in terms of fibrosis. And that would steer us in relationship to what we would do next.

另一個是 SSc-ILD 的 2 期臨床試驗。我需要看看，因為如果我在克羅恩病中看到這種情況，那麼你突然開始談論的就不僅僅是類似於其他抗細胞因子，抑制炎症，那麼你在纖維化方面就有了優勢。這將指導我們下一步的行動。

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

Hi, thanks so much. So your team has talked about a 1.0 and 2.0 solid tumor strategy, with 1.0 being sac-TM3 -- sorry, sac-TMT and then 2.0 is combining the ADCs with the PD-1 VEGF. At ESMO, it looked like your TROP2 is showing a 6- to 12-month benefit on overall survival, at least it's trending that way in second line.

您好，非常感謝。所以你們團隊討論了 1.0 和 2.0 實體瘤策略，其中 1.0 是 sac-TM3——抱歉，是 sac-TMT，而 2.0 是將 ADC 與 PD-1 VEGF 結合。在 ESMO 會議上，TROP2 療法似乎能讓整體存活期延長 6 至 12 個月，至少在二線治療中，這種趨勢是成立的。

And that's triple what we're seeing with the PD-1 VEGF. So what gets you more excited? The signal you're seeing with your TROP2 or the PD-1 VEGF class? And how does that impact your appetite to potentially run another round of Phase III combo trials with the LaNova asset? Thank you.

這比我們看到的 PD-1 VEGF 的三倍高。那麼，什麼更能讓你興奮呢？你用 TROP2 或 PD-1 VEGF 類抗體檢測到的訊號是什麼？那麼，這會對您進行另一輪 LaNova 聯合療法 III 期試驗的意願產生怎樣的影響呢？謝謝。

Yes. So I should probably reset. I don't believe that we've said anything in relationship to how you've talked about it in terms of the different phases. We are extremely excited about the TROP2, the sac-TMT, and we've had a productive relationship with Kelun.

是的。所以我可能應該重置一下。我認為我們還沒有就你從不同階段的角度談論過任何事情。我們對 TROP2 和 sac-TMT 感到非常興奮，並且我們與科倫公司建立了富有成效的合作關係。

One of the things I would just emphasize is it's very easy to sit there and say -- oh, this is a TROP2 ADC, and we throw all the TROP2 ADCs in a bucket as if they're not different. I think the recent data suggests that there may be differences, and we're really interested as we move 15 Phase 3 studies, but 10 of them are actually in places where the other TROP2s haven't gone.

我想強調的一點是，很容易坐在那裡說——哦，這是一個 TROP2 ADC，然後我們把所有 TROP2 ADC 都歸為一類，好像他們沒有區別一樣。我認為最近的數據表明可能存在差異，我們對此非常感興趣，因為我們正在推進 15 項 3 期研究，但其中 10 項實際上是在其他 TROP2 尚未涉足的領域。

So we're very interested in pushing the sac-TMT with and in the appropriate place with IO or with other precision targeted. In relationship to the PD-1 VEGF, we're also interested in advancing that and seeing that data just evolve not just with us, but from the outside world. And that will define to us where we would put the PD-1 VEGF in relationship to PD-1.

因此，我們非常有興趣將 sac-TMT 與 IO 或其他精確標靶技術結合使用，並部署到適當的位置。關於 PD-1 VEGF，我們也對推進其研究感興趣，並希望看到相關數據不僅在我們自身領域內發展，而且在外部世界也能持續發展。這將有助於我們確定 PD-1 VEGF 與 PD-1 的關係。

But I just want to just make sure that we're very excited about the sac-TMT. We've shown data, Kelun has shown data. You've highlighted how it's different. We believe that we're eager to see the trials that can drive that in -- not just in the Chinese patient populations, but in the US and globally.

但我只想確保我們對 sac-TMT 感到非常興奮。我們已經展示了數據，科倫也展示了數據。你已經指出了它的不同。我們相信，我們渴望看到能夠推動這一目標實現的試驗——不僅是在中國患者群體中，而且在美國和全球範圍內。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Hi guys, I wanted to just touch on the ENFLONSIA launch in the United States. Heading into RSV season, can you just talk about the initial feedback, say, versus the competition and kind of what you're seeing in terms of potential uptake as we head into RSV season. Thank you.

大家好，我想簡單談談ENFLONSIA在美國的上市情況。眼看 RSV 流行季即將到來，您能否談談初步回饋，例如與競爭對手相比，以及隨著 RSV 流行季的臨近，您認為潛在的市場接受度會如何？謝謝。

Yes. Maybe I'll start, and then if Caroline wants to jump in, she can as well. Overall, we feel good about where we are with ENFLONSIA. If you look at how that launch has progressed, I would point out that while we did receive, obviously, all the full approvals we were a couple of weeks later than initially expected. So that did play into this because it put us a little bit later into the season. We did highlight, as Caroline pointed out in the prepared remarks, there was $75 million -- or $79 million of initial stocking, and that really was the seeding order from the VFC as well as other wholesaler distributor stocking.

是的。也許我可以先開始，如果卡洛琳也想加入，她也可以。總體而言，我們對 ENFLONSIA 目前的進展感到滿意。如果你看看這次發表會的進展情況，我想指出，雖然我們顯然獲得了所有完整的批准，但我們比最初預期的晚了幾個星期。所以這確實對比賽結果產生了一定影響，因為這讓我們在賽季中稍微晚了一些開始。正如卡羅琳在準備好的發言稿中指出的那樣，我們確實強調了，初始庫存為 7500 萬美元，或者說是 7900 萬美元，這實際上是 VFC 以及其他批發分銷商的種子訂單。

So as we sit here right now looking at the season and into next year, we really continue to see an opportunity. I would point out, if you think about the benefits ENFLONSIA brings, there's no weight-based dosing, our ability to look at our total contracted portfolio of vaccines. All of the things we've talked about continue to make us believe this will be a very important vaccine. And as we look forward into '26 and beyond, we continue to see that. We'll see where the rest of '25 plays out, but it's -- all in all, given the timing of when we started, we feel good.

所以，當我們現在展望本賽季和明年時，我們仍然看到很多機會。我想指出的是，如果您考慮 ENFLONSIA 帶來的好處，它沒有基於體重的劑量限制，我們可以查看我們所有已簽約的疫苗組合。我們討論的所有內容都讓我們更加相信，這將是一種非常重要的疫苗。展望 2026 年及以後，我們將繼續看到這種情況。2025 年剩下的時間會如何發展，我們拭目以待，但總的來說，考慮到我們開始的時間，我們感覺很好。

And just to add to Rob's comments, we had the seeding order in the third quarter. We expect that to be utilized during the fourth quarter. Feedback from customers has been very good, and we look forward to having an impact this season and much more of an impact as we go into 2026.

補充一下羅布的評論，我們在第三節確定了種子排名。我們預計這將在第四季度得到利用。顧客的回饋非常好，我們期待在本季產生影響，並期待在 2026 年產生更大的影響。

Daina Graybosch, Leerink Partners.

Daina Graybosch，Leerink Partners。

Hi, thank you for the question. I wonder if you could give us an update on KEYTRUDA and the proportion of the sales that you have from early-stage settings and a breakdown of which of those tumor types of the 10 approved is driving that revenue?

您好，感謝您的提問。我想請您介紹一下 KEYTRUDA 的最新情況，以及早期階段的銷售佔比，並詳細說明在已批准的 10 種腫瘤類型中，哪些腫瘤類型是主要收入來源？

Yes. I'll start, Daina, and then Caroline can jump in as well. So if you recall, if you look at where we are in the earlier-stage setting, we have currently 10 approved indications, now 5 with overall survival, which is important.

是的。我先開始，黛娜，然後卡洛琳也可以加入。所以如果你還記得的話，如果你看看我們在早期階段的情況，我們目前有 10 個獲批適應症，現在有 5 個可以提高總生存率，這很重要。

And if you look at where we are going forward, the drivers of that in that cervical continues to be important, RCC, we continue to see TNBC and non-small cell lung cancer, all are important drivers. We're obviously excited. We don't have approval yet, but you heard that we have yet another potential OS benefit coming, 905, I believe it is, that Dean spoke about earlier. So yet more coming, and that's in muscle invasive bladder cancer.

展望未來，子宮頸癌、腎細胞癌、三陰性乳癌和非小細胞肺癌等都是重要的驅動因素。我們當然很興奮。我們還沒有獲得批准，但你們也聽說了，我們還有另一個潛在的作業系統優勢即將到來，我相信是 905，迪恩之前提到過。所以還有更多內容即將推出，那就是肌肉浸潤性膀胱癌。

So a lot out there, we're excited about where it goes. It's driving over half of our growth. Right now, it's coming from earlier-stage indications. And we achieved -- if you look back to -- we indicated we would be at 25% in 2024, and '25, we're now -- we're exceeding 25%. We have not given specific targets, but we see it growing as a percent overall of total sales, and it's over half of our growth. So it is an important driver, especially as we think about the QLEX launch that is just starting to get underway.

所以有很多東西值得期待，我們對它的發展方向感到興奮。它為我們帶來了超過一半的成長。目前來看，這些跡像都來自早期階段的跡象。我們已經實現了——回顧過去——我們曾表示我們將在 2024 年和 2025 年達到 25%，而現在——我們已經超過了 25%。我們沒有設定具體目標，但我們看到它佔總銷售額的百分比正在成長，而且它占我們成長的一半以上。因此，這是一個重要的驅動因素，尤其是在我們考慮即將開始的 QLEX 系統發布之際。

Chris Schott, JP Morgan.

克里斯‧肖特，摩根大通。

Great. Thanks so much. Just Rob, a question on MFN. I appreciate the color in the prepared remarks. But just following some of the recent deals with the administration, both with Pfizer and Astra, should we be thinking about this type of structure as a reasonable framework for the industry? And just any updates in terms of where Merck is in terms of its discussion with the administration on MFN. Thank you.

偉大的。非常感謝。羅布，我有個關於最惠國待遇的問題。我欣賞準備好的演講稿中所展現出的豐富色彩。但是，鑑於最近政府與輝瑞和阿斯特捷利康達成的一些協議，我們是否應該將這種結構視為該行業的合理框架？還有，關於默克公司與政府就最惠國待遇問題進行的討論，有什麼最新進展嗎？謝謝。

Yes, Chris, thanks for the question. As I said in the prepared remarks, overall, we're aligned with what the administration is trying to achieve, which is to lower the out-of-pocket cost for patients at the pharmacy counter and at the same time, to get foreign prices up to ensure that foreign governments are paying their fair share.

是的，克里斯，謝謝你的提問。正如我在準備好的演講稿中所說，總的來說，我們與政府的目標一致，即降低患者在藥房櫃檯的自付費用，同時提高外國藥品價格，以確保外國政府支付其應盡的份額。

So those broad-based principles, we're aligned with. We are in continuing discussions with the administration. I'm not going to give any specific updates other than to say, I am very optimistic that we're going to have a constructive outcome to those discussions. And the framework, we'll wait until we actually have something to talk about there to be more specific to how we see ours coming out.

所以，我們認同這些廣泛的原則。我們正在與政府部門繼續進行磋商。除了說我對這些討論能夠取得建設性成果非常樂觀之外，我不會透露任何具體細節。至於框架方面，我們會等到真正有了可以討論的內容之後，再更具體地說明我們對框架的想像。

Carter Gould, Cantor.

卡特·古爾德，坎托爾。

Good morning. Thanks for taking the question. You had a pair of good WELIREG data recently. So Dean, I wanted to ask you around your confidence in ultimately hitting on OS in the 022 study and the importance of that in moving the needle on adoption in that setting.

早安.感謝您回答這個問題。您最近獲得了兩份不錯的 WELIREG 數據。所以迪恩，我想問你，你對最終在 022 研究中發現 OS 的信心有多大，以及這在推動該領域採用率方面的重要性。

Yes. So we are equally excited about the WELIREG. It's a first-in-class treatment. We've announced the top line Phase 3 for the second line as well as the adjuvant. And I also think it's important that in one of the trials, the ability of a HIF-2 alpha to do something on top of the VEGF blocking agent is important.

是的。所以我們對 WELIREG 也同樣感到興奮。這是首屈一指的治療方法。我們已經公佈了二線療法以及輔助療法的第三期臨床試驗結果。而且我認為，在其中一項試驗中，HIF-2 α 在 VEGF 阻斷劑的基礎上發揮作用的能力也很重要。

In relationship to OS, I think OS is always really important. It's important for the FDA, but most importantly, it's important for patients. So we are really eagerly awaiting to see if and when we cross that boundary. And so yes, we are excited, and we have a broad portfolio program in WELIREG. And so we'll be anxious to share those results when we get them.

就作業系統而言，我認為作業系統始終非常重要。這對FDA來說很重要，但最重要的是，這對患者來說很重要。所以我們非常熱切地期待著看看我們是否以及何時會跨越那條界限。所以，是的，我們感到很興奮，我們在 WELIREG 中擁有廣泛的投資組合計劃。因此，一旦我們獲得結果，我們將迫不及待地與大家分享。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

Hi, thanks for taking the question. Caroline, I know you commented somewhat on expenses for 2026. I was just wondering if you can give us any comments on the top line in terms of some of the pushes and pulls as we think about that, recognizing you probably don't want to give guidance yet at this point, but just maybe help us think through some of the levers there. Thank you.

您好，感謝您回答這個問題。卡羅琳，我知道你對 2026 年的開支發表了一些評論。我只是想問您能否就一些影響我們決策的因素，例如一些推動和拉動因素，給我們一些建議。我知道您可能不想在這個時候給予指導，但或許可以幫我們理清一些關鍵的槓桿作用。謝謝。

Yes. Of course, Terence. So as we go into 2026, we are expecting solid top line growth for our company, and that growth will increasingly be fueled by the number of new launches that we have. So we're expecting continued patient impact and revenue growth from WINREVAIR. OHTUVAYRE now is also part of the Merck portfolio. We have CAPVAXIVE, which is off to a very strong start, and ENFLONSIA.

是的。當然，特倫斯。因此，展望 2026 年，我們預計公司營收將實現穩健成長，而這種成長將越來越多地由我們推出的新產品數量所推動。因此，我們預計 WINREVAIR 將持續為患者帶來正面影響，並實現收入成長。OHTUVAYRE 現在也是默克公司產品組合的一部分。我們有 CAPVAXIVE，它開局非常強勁，還有 ENFLONSIA。

And on top of that, we have our Animal Health business, where growth will also be driven by new launches, including BRAVECTO QUANTUM, the 12-month injection, as well as NUMELVI, our new dermatology product. We also have the expectation of continued growth in oncology.

除此之外，我們還有動物保健業務，這項業務的成長也將由新產品的推出推動，包括 12 個月注射劑 BRAVECTO QUANTUM 以及我們的新皮膚病產品 NUMELVI。我們也預期腫瘤學領域將持續成長。

To the last question, WELIREG, has strong growth with greater potential ahead of it as we get into other successful studies and treat a broader range of patients. And we do expect continued growth in KEYTRUDA, albeit at a slightly slower pace than we've seen as we are getting to peak penetration in some of the indications, and we do expect some headwind from price in our ex-US markets.

對於最後一個問題，WELIREG 具有強勁的成長勢頭，隨著我們進行其他成功的研究並治療更廣泛的患者群體，其未來發展潛力更大。我們預期 KEYTRUDA 將繼續成長，儘管成長速度會比之前略慢，因為在某些適應症中，我們的滲透率已接近高峰；而且我們預期在美國以外的市場，價格方面會面臨一些不利因素。

The other headwinds that we will face will be related to loss of exclusivity and generic entrants. And that really is DIFICID that's seen generic entrant halfway through 2025 in the US, BRIDION, which will have its LOE partway through 2026. And we also expect the headwind of IRA price setting on the JANUVIA family and the generic entrant for JANUVIA midway through next year. But overall, confident in our ability to continue to positively impact patients and drive solid growth.

我們將面臨的其他不利因素與獨家銷售權的喪失和仿製藥的湧入有關。而真正的 DIFICID 的仿製藥 BRIDION 將於 2025 年中在美國上市，預計將於 2026 年年中上市。我們也預計，明年年中，IRA定價機制將對捷諾維（JANUVIA）系列藥物以及捷諾維的仿製藥上市構成不利影響。但總的來說，我們有信心繼續為患者帶來正面影響，並推動穩健成長。

Umer Raffat, Evercore.

Umer Raffat，Evercore。

Hi guys, thanks for taking my question. I was wondering if I should ask about Organon situation, but I realize it's multiple years removed, stand-alone company. So maybe there's not a whole lot you could say anyways. So let me focus instead on CADENCE trial instead.

大家好，感謝你們回答我的問題。我本來在想是否應該問問 Organon 的情況，但我意識到那已經是很多年前的獨立公司了。所以，或許你也沒什麼好說的了。所以，我還是把重點放在 CADENCE 試驗上吧。

And Dean, my question is, it finished late September. You're indicating first half '26. It sounds to me like that's a little longer than I would have expected to get the readout out there on 150-patient trial. So could you just catch us up on your thought process there?

迪恩，我的問題是，它在九月下旬結束。你指的是 2026 年上半年。聽起來，要得出 150 名患者的試驗結果，所需時間比我預期的要長一些。那麼，您能簡單介紹一下您的思考過程嗎？

Yes. So just as everyone knows, we have ZENITH, HYPERION earlier in disease, those data have come through. We have a primary completion date of CADENCE this year, and we said that we would be presenting it to the data in a meeting. I believe that we will be putting out a top line once we know it as well. So when we talked about the first half of -- or the first quarter or first half of 2026, we were talking about the full data at a medical meeting.

是的。如大家所知，我們在疾病早期階段就有了 ZENITH 和 HYPERION，這些數據已經得到了證實。我們今年已經確定了 CADENCE 的主要完成日期，我們說過會在一次會議上向大家展示數據。我相信一旦我們掌握了相關信息，就會公佈最終結果。所以，當我們談到 2026 年上半年——或者第一季或上半年時，我們是在醫學會議上討論完整的數據。

We are eager to see that result because that result will suggest to us how much we can use WINREVAIR outside of the patient population that's formally PAH. And so we're eager to see those results as well.

我們渴望看到結果，因為該結果將告訴我們，在正式確診為 PAH 的患者群體之外，我們能使用 WINREVAIR 的程度如何。所以我們也迫切希望看到這些結果。

Courtney Breen, Bernstein.

Courtney Breen，Bernstein。

Hi everyone, thanks so much. For taking my question today. Just coming back to some of the White House price policy pressures and comments you've made already. I wanted to ask this in a slightly different way. If we look at kind of Merck's ratio of revenue today, it's about 50/50 inside the US versus outside the US.

大家好，非常感謝。感謝您今天回答我的問題。我再回到您之前提到的一些關於白宮價格政策壓力和評論。我想換個方式問這個問題。如果我們看一下默克公司目前的營收比例，大約是美國境內收入與美國境外收入各佔50%。

How different do you expect that to be in five years' time? And how much of that could be attributed to product mix? And how much down to kind of equalization of price? Thank you so much.

你預計五年後情況會有多大不同？其中有多少可以歸因於產品組合？那麼，價格均衡化究竟能達到什麼程度呢？太感謝了。

Yes, Courtney, thanks for the question. I'm not going to get into specific guidance. Obviously, if you look at where our business is driving, we're excited about the diversity of the pipeline we're bringing. A lot of those opportunities disproportionately will be US based, primarily just because of the nature of the drugs and the uptakes and the value you can assert to the US market.

是的，考特尼，謝謝你的提問。我不會給出具體指導。顯然，從我們業務的發展方向來看，我們對正在引入的多元化產品線感到興奮。許多這樣的機會將不成比例地集中在美國，這主要是因為藥物的性質、市場接受度以及你能夠向美國市場證明的價值。

So mix will affect how we look forward. How MFN or other pricing dynamics change, it's too early to say because we need to see what it is. And so I would leave it at that for right now.

所以，這種混合模式將影響我們展望未來的方式。最惠國待遇或其他定價動態將如何變化，現在下結論還為時過早，因為我們需要觀察其具體情況。所以，我暫時就說到這裡吧。

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Great, thanks for taking my questions. So I appreciate the comments around 2026 and how to think about some of the driver there. I had a question just more on GARDASIL. Maybe it's a good thing that we haven't talked much about GARDASIL on this call, but just obviously a challenging year for that product.

太好了，謝謝你回答我的問題。因此，我很感謝大家對 2026 年的評論，以及如何思考其中的一些驅動因素。我還有一個關於加衛苗的問題。也許我們在這次電話會議上沒有過多討論加衛苗（GARDASIL）是件好事，但很顯然，對於這款產品來說，今年是充滿挑戰的一年。

I'm curious how you think about that product sort of in 2026 and beyond, both in the US, where obviously, there's been sort of evolving sentiment around vaccinations and maybe some -- could be an adjustment to the guidelines around the US recommendations, but also then ex-US, given you'll be annualizing out of the China and Japan impact.

我很好奇您如何看待該產品在 2026 年及以後的發展，包括在美國（顯然，人們對疫苗接種的態度一直在變化，美國的相關建議可能會有所調整），以及在美國以外的地區（考慮到您將逐年消除中國和日本的影響）。

So just any sense of -- I think consensus is expecting a sort of robust return to growth for that product over the next several years. Just curious how you're thinking about that.

所以，我認為普遍的預期是，未來幾年該產品將強勁復甦，實現成長。只是好奇你怎麼想的。

Thank you for the question, Vamil. So GARDASIL still remains a very important product, and we're really proud of the impact that we're having in helping protect people from certain HPV-related cancers. As we look forward, in the United States indeed today, we are seeing growth in our vaccinations in the 9, 10 age group as well as the mid-adult segment. And that's being offset by a lower level in the adolescent segment, and that's really driven by a reduction in the eligible population, and there are some macro factors there.

謝謝你的提問，Vir。因此，加衛苗仍然是一款非常重要的產品，我們為在幫助人們預防某些 HPV 相關癌症方面所發揮的作用感到非常自豪。展望未來，如今在美國，我們看到9歲、10歲年齡層以及中年人口的疫苗接種率都在增加。而青少年群體的低水平抵消了這一影響，這主要是由於符合條件的人口減少所致，其中還有一些宏觀因素。

As we look forward for the United States, we are hopeful for growth. But clearly, as you mentioned, the ACIP recommendation around that dosing schedule will very much impact whether we do or don't grow in the United States. And as we've said before, we will always look at having the appropriate price point in the United States based on the value that we are providing society.

展望美國的未來，我們對發展充滿希望。但很顯然，正如您所提到的，ACIP 關於該給藥方案的建議將對我們是否在美國種植產生很大的影響。正如我們之前所說，我們將始終根據我們為社會提供的價值，在美國設定合適的價格點。

Outside of the United States, you rightly note that we will lap the impact of China as well as the reduction in the cohort for the catch-up in Japan as we go through 2026. So we look forward to protecting more people around the world.

在美國以外，正如您所指出的，隨著我們進入 2026 年，我們將逐漸克服中國的影響以及日本追趕人口減少的影響。因此，我們期待著保護世界各地更多的人。

What we're seeing in countries outside of the United States, some of the public programs have really reached maturity. So we expect a routine cohort to be vaccinated each and every year. The private market is a great opportunity for growth for us. And that's really in the mid-adult segment, age 27 through 45, where we're creating the system to enable people to get vaccinated in many countries around the world.

我們看到，在美國以外的一些國家，一些公共計畫已經真正成熟了。因此，我們預計每年都會有一批常規人群接種疫苗。私人市場對我們來說是一個絕佳的成長機會。而這主要針對的是27歲至45歲的中年族群，我們正在建立一套系統，讓世界各地的人們都能接種疫苗。

And it's also in some countries in the broad age cohort. So we will be working to activate that cohort. It does take time, but we'll be activating that cohort to drive growth in the private segment as we go forward. Overall, we expect modest growth for GARDASIL in the near term.

而且在一些國家，這種現像也出現在更廣泛的年齡層中。因此，我們將努力激活這部分人群。這確實需要時間，但我們將逐步激活這部分人群，以推動私人領域的成長。總體而言，我們預計 GARDASIL 在短期內將達到溫和成長。

Luisa Hector, Berenberg.

路易莎·赫克托，貝倫貝格。

Hello, thank you for taking my question. Just back to KEYTRUDA. Could you just update us on your latest expectations for conversion from IV to subcutaneous and the kind of pace that we could expect? And with that in mind, Caroline, you made a comment on KEYTRUDA growth at a slower pace for '26. So just to check whether that is the overall franchise or IV only? And will you report the sales separately? Thank you.

您好，感謝您回答我的問題。回 KEYTRUDA。能否告知我們您對從靜脈注射轉換為皮下注射的最新預期，以及我們可以預期的進展速度？考慮到這一點，卡羅琳，你曾評論 KEYTRUDA 在 2026 年的成長速度會放緩。所以我想確認一下，這是整個系列的問題，還是只是指第四部？你們會單獨報告銷售嗎？謝謝。

Yes. Luisa, this is Rob. I'll maybe start and then Caroline can address the last part of your question. So if you look at expectations for QLEX, as we've said, it's early in the launch, but everything appears to be on track. And there's no changes to what we previously communicated.

是的。路易莎，這位是羅布。我先來，然後卡洛琳可以回答你問題的最後一部分。所以，正如我們所說，從對 QLEX 的預期來看，雖然現在還處於發布初期，但一切似乎都按計劃進行。我們之前溝通的內容沒有任何改變。

We continue to expect that we're going to achieve 30% to 40% patient adoption and that, that will take us out to 18 to 24 months to achieve that. So nothing has changed there. I would highlight, as we've pointed out in the past, that we will have a permanent J-code, but we won't get that probably for six months. And during that first six-month window, you can anticipate a slower uptick just because with people using temporary J-codes, there can be longer reimbursement windows. And so some people will hesitate to order until they have the permanent J-code.

我們仍然期望達到 30% 到 40% 的患者採用率，而要實現這一目標，我們需要 18 到 24 個月的時間。所以那裡沒有任何變化。正如我們過去指出的那樣，我想強調的是，我們將擁有一個永久的 J 代碼，但我們可能要六個月後才能獲得它。在最初的六個月窗口期內，您可以預期增長速度會放緩，因為使用臨時 J 代碼的人可以獲得更長的報銷窗口期。因此，有些人會猶豫是否要訂購，直到他們獲得永久 J 代碼。

We've done everything we can to learn from the other subcutaneous products that have launched ahead of us. I can tell you that we've put in place, I believe, a commercial contracting strategy that really will make it frictionless to convert patients over, or in the cases of new patients, to adopt the therapy, and that's important to make sure that we are driving this because access and conversion are what is our goal or adoption is the goal we have moving forward.

我們已經盡一切努力從其他先於我們推出的皮下注射產品中學習。我可以告訴大家，我們已經制定了一項商業合約策略，我相信這項策略能夠真正讓患者順利過渡到治療方案，或者對於新患者來說，讓他們接受治療，這一點非常重要，因為獲得治療和轉化是我們的目標，或者說，推廣治療是我們未來發展的目標。

I'll let Caroline speak to her comments about the overall growth next year.

我會讓卡羅琳來談談她對明年整體成長的看法。

Yes. So Luisa, the comments I gave were with regards to KEYTRUDA in its entirety, where we expect KEYTRUDA to slow although it'd be an important contributor to growth for our company. Within that, to Rob's point, we are really excited about the contributions that QLEX can bring as we do provide treatment options for more and more patients as next year unfolds.

是的。所以 Luisa，我之前的評論是針對 KEYTRUDA 整體而言的，我們預計 KEYTRUDA 的成長速度將會放緩，儘管它仍將是我們公司成長的重要貢獻者。正如羅布所說，我們非常高興 QLEX 能為越來越多的患者提供治療選擇，隨著明年的到來，我們將受益匪淺。

And we will anticipate reporting separately in 2026.

我們預計將於 2026 年單獨發布報告。

Alex Hammond, Wolfe Research.

Alex Hammond，Wolfe Research。

Thanks for taking the question. On EyeBio, can you help with the Phase III BRUNELLO result in context? What's the bar to deem the trial a success? And I guess given the competitive nature of this indication, how do you plan to execute commercially?

感謝您回答這個問題。EyeBio，您能幫忙解讀一下 BRUNELLO III 期臨床試驗的結果嗎？如何界定審判的成功？鑑於此適應症的競爭性質，您打算如何進行商業推廣？

Well, let me just say that we're really excited about pushing this first-in-class MK-3000 novel candidate targeting the Wnt pathway. I would just remind, I believe this is the first time a novel mechanism has been pushed through in relationship to having clear human genetic evidence for it, and we plan to evaluate that MK-3000, not just in diabetic macular edema, but also neovascular age-related macular degeneration as well.

嗯，我只想說，我們非常興奮地推進這款針對 Wnt 通路的首創新候選藥物 MK-3000。我只想提醒大家，我相信這是首次有明確的人類遺傳證據支持的新機制被提出，我們計劃評估 MK-3000，不僅用於治療糖尿病性黃斑水腫，還用於治療新生血管性老年黃斑部病變。

In terms of commercial sort of execution, I would hold off until we see the data from these trials, but we're pushing very fast and very forward in relationship to this because this could be one of the first new mechanisms, kind of like the WINREVAIR story, where it's the first generally new mechanism that can make a profound effect on such a broad disease.

就商業執行而言，我會等到看到這些試驗的數據後再做決定，但我們正在非常快速地推進這項工作，因為這可能是首批新機制之一，有點像 WINREVAIR 的故事，它是第一個能夠對如此廣泛的疾病產生深遠影響的全新機制。

Yes. And maybe just to add a little bit on the commercial opportunity. And if you look at where we are today in the United States, there's about 1.6 million patients with diabetic macular edema. So this is the leading cause of vision loss in people with diabetes. And so as you look at that population, still, there's a very large opportunity because 30% to 40% of patients on therapy are not responsive to the current anti-VEGF. So the ability potentially to see conversions is significant. If you look, it's about a $13 billion market today, and we believe that our ability to drive that kind of conversion with this new molecular entity is important.

是的。或許還可以補充一點關於商業機會的內容。如果你看看我們今天在美國的處境，你會發現大約有 160 萬名糖尿病性黃斑水腫患者。所以這是導致糖尿病患者視力喪失的主要原因。因此，當你審視這部分人群時，你會發現仍然有很大的機會，因為 30% 到 40% 的患者在接受治療時對目前的抗 VEGF 藥物沒有反應。因此，能夠看到轉換率是非常重要的。你看，如今這是一個價值約 130 億美元的市場，我們相信，我們利用這種新的分子實體推動這種轉化的能力非常重要。

As far as the commercial infrastructure, we're really combining the EyeBio's leadership strengths and our expertise in ophthalmology and pushing these forward, and I'm quite confident that we will have the global infrastructure to be able to drive this. We're investing pretty heavily behind this.

就商業基礎設施而言，我們正在真正結合 EyeBio 的領導優勢和我們在眼科領域的專業知識，並推動這些優勢向前發展，我很有信心我們將擁有推動這一發展的全球基礎設施。我們在這方面投入了相當多的資金。

And when you look at this and combined with the Tiespectus, this is a multibillion-dollar opportunity for the company. We're very excited. I think this is one of the underappreciated areas of what we have, and I credit Dean and the team, they've advanced these by a couple of years from what we originally anticipated when we did the deal. So this is a win in my book.

當你考慮到這一點，再加上 Tiespectus，這對公司來說是一個價值數十億美元的機會。我們非常興奮。我認為這是我們擁有的領域中被低估的領域之一，我要感謝迪恩和他的團隊，他們使這些領域比我們最初達成交易時預期的提前了幾年。所以在我看來，這是一場勝利。

Great. Thank you Alex. Thank you all for your great questions, and we'll end the call there. Please reach out to the IR team if you have any follow-ups.

偉大的。謝謝你，亞歷克斯。感謝大家提出的精彩問題，我們的通話就到此結束。如有任何後續事宜，請聯絡投資者關係團隊。

Thank you for your participation. Participants, you may disconnect at this time.

感謝您的參與。各位參與者，現在可以斷開連接了。