默克藥廠 (MRK) 2026 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)

歡迎參加美國新澤西州拉威市默克公司（Merck & Co., Inc.）第三季銷售與盈餘電話會議。（接線員指示）

This call is being recorded. If you have any objections, you may disconnect at this time.

本通話將被錄音。如您有任何異議，請於此時中斷連線。

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

現在我想將電話交給投資人關係資深副總裁 Peter Dannenbaum 先生。先生，您可以開始了。

Thank you, Julie, and good morning, everyone. Welcome to the third-quarter 2026 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 Laboratories.

謝謝你，Julie，各位早安。歡迎參加美國新澤西州拉威市默克公司（Merck & Co., Inc.）2026 年第三季電話會議。今天出席並發言的有董事長兼執行長 Rob Davis；財務長 Caroline Litchfield；以及研究實驗室總裁 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.

在開始之前，我想指出，我們的 GAAP 業績中包含若干項目，例如與併購相關的費用、重組成本及其他特定項目；我們已將這些項目自非 GAAP 業績中排除。我們的新聞稿中提供了對帳表。

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.

我也要提醒各位，我們今天所做的部分陳述，可能構成 1995 年《美國私人證券訴訟改革法》安全港條款所定義的前瞻性陳述。此類陳述係基於本公司管理階層目前的信念作出，並受重大風險與不確定性影響。若我們的基本假設被證明不正確或不確定性成真，實際結果可能與前瞻性陳述所載內容有重大差異。

Our SEC filings, including Item 1A and the 2025 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.

我們向 SEC 提交的文件（包括第 1A 項及 2025 年 10-K）載明若干風險因素與警示性聲明，可能導致公司實際結果與我們今早任何前瞻性陳述所預期者有重大差異。美國新澤西州拉威市默克公司（Merck & Co., Inc.）不承擔公開更新任何前瞻性陳述之義務。

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.

在今天的電話會議中，我們的講者預先準備的發言將搭配投影片簡報。這些投影片、盈餘新聞稿、今日的預備講稿以及我們向 SEC 提交的文件，均已張貼於本公司網站的投資人關係專區。

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

接下來，我想把電話交給 Rob。

Thank you, Peter. Good morning and thank you for joining today's call.

謝謝你，Peter。各位早安，感謝各位參加今天的電話會議。

2026 continues to be a year of substantial progress for our company. We're executing well on all fronts, demonstrated particularly by the many new product launches now successfully underway and the important clinical milestones we're achieving that are further de-risking the substantial long-term opportunity of our late phase pipeline. This momentum extends across multiple therapeutic areas and modalities and there is much more to come with numerous significant readouts still to occur over the coming years.

2026 年對我們公司而言仍是取得重大進展的一年。我們在各方面執行良好，尤其體現在多項新產品上市已成功展開，以及我們達成的重要臨床里程碑，進一步降低了我們後期研發管線所蘊含龐大長期機會的風險。這股動能橫跨多個治療領域與技術平台；未來仍有更多進展可期，且在未來數年仍將有多項重要讀出結果陸續公布。

I'm very pleased that the disciplined execution of our strategy over the past several years is increasingly translating into meaningful clinical, regulatory, and commercial results. The breadth of these achievements strengthens my confidence in the future of our company and our ability to deliver long-term value for patients and shareholders.

我非常高興，過去數年我們對策略的紀律性執行，正日益轉化為具意義的臨床、法規與商業成果。這些成就的廣度強化了我對公司未來以及我們為病患與股東創造長期價值能力的信心。

Turning to our third-quarter results, we delivered solid performance with revenue of $18.1 billion, reflecting increased contributions from new products as well as strength in Oncology and Animal Health. Caroline will discuss our results and the full-year outlook in greater detail in a moment.

談到第三季業績，我們交出穩健表現，營收為 181 億美元，反映新產品貢獻提升，以及腫瘤與動物保健業務的強勁表現。Caroline 稍後將更詳細說明我們的業績與全年展望。

We also achieved several important clinical and regulatory milestones. In Oncology, last weekend's ESMO meeting showcased potential practice-changing advances for several innovative programs highlighted by the first positive Phase 3 results from our expansive global TroFuse program for sac-TMT in advanced or recurrent endometrial cancer. Additional data shared at the meeting from our partner Kelun further support the potential of sac-TMT in lung cancer and other tumor types.

我們也達成數項重要的臨床與法規里程碑。在腫瘤領域，上週末的 ESMO 會議展示了多項可能改變臨床實務的創新進展，其中亮點包括我們規模龐大的全球 TroFuse 計畫中，針對晚期或復發性子宮內膜癌之 sac-TMT 首次取得正向的第三期結果。會議中亦分享了合作夥伴科倫（Kelun）的更多數據，進一步支持 sac-TMT 在肺癌及其他腫瘤類型的潛力。

And we are encouraged by the landmark validation of a therapeutic cancer vaccine with positive Phase 3 data presented for intismeran autogene as an adjuvant treatment for certain patients with melanoma. This new approach may offer a tangible opportunity to change the trajectory of a patient's cancer.

此外，我們也受到鼓舞：作為治療性癌症疫苗的里程碑式驗證，intismeran autogene 以輔助治療用於特定黑色素瘤病患的第三期正向數據已對外發表。這種新方法可能為改變病患癌症病程帶來具體機會。

In Ophthalmology. We presented results from the BRUNELLO study evaluating remigromig in diabetic macular edema, a significant milestone for our rapidly advancing retinal disease portfolio.

在眼科領域。我們公布了 BRUNELLO 研究結果，評估 remigromig 用於糖尿病黃斑水腫，這是我們快速推進的視網膜疾病產品組合的一項重要里程碑。

And finally, in Immunology, we presented encouraging Phase 2b results in HS and look forward to advancing our TL1A development program.

最後，在免疫學領域，我們公布了 HS 的令人鼓舞的 2b 期結果，並期待推進我們的 TL1A 開發計畫。

This year's clinical and commercial progress underlines the ongoing transformation of our business and provides us with greater visibility into the trajectory of our emerging and expansive new product portfolio. The opportunity we have to drive strong long-term growth beyond the KEYTRUDA LOE period is becoming increasingly clear as we achieve these scientific and commercial milestones.

今年在臨床與商業上的進展，凸顯我們業務持續轉型，並讓我們對新興且規模龐大的新產品組合發展軌跡有更高的能見度。隨著我們達成這些科學與商業里程碑，我們在 KEYTRUDA 專利到期（LOE）期間之後推動強勁長期成長的機會正變得愈發清晰。

As we look ahead, we'll remain focused on successfully executing our launches, broadening and advancing our pipeline, and making meaningful investments to realize the full potential of these opportunities. I want to recognize and thank our dedicated global teams for their ongoing commitment to delivering value for patients, shareholders, and all of our stakeholders.

展望未來，我們將持續專注於成功推進產品上市、擴大並推進研發管線，並進行具意義的投資，以充分實現這些機會的全部潛力。我也要表揚並感謝我們全球團隊的投入與承諾，持續為病患、股東以及所有利害關係人創造價值。

And now I'll turn the call over to Caroline.

現在我把電話交給 Caroline。

Thank you, Rob. Good morning. As Rob noted, we delivered solid performance in the quarter, driven by increasing contributions from our compelling array of important new products and continued strength in Oncology and Animal Health.

謝謝你，Rob。各位早安。如 Rob 所提，我們本季表現穩健，主要受惠於一系列具吸引力的重要新產品貢獻提升，以及腫瘤與動物保健業務持續強勁。

Strong commercial and operational execution continues to propel our near-term performance while we invest to optimize our launches and advance our broad and deep pipeline to create long-term value for patients, customers, and shareholders.

強勁的商業與營運執行持續推動我們的短期表現；同時我們也投入資源以最佳化上市推進，並推動我們廣度與深度兼具的研發管線，為病患、客戶與股東創造長期價值。

Now turning to our third-quarter results. Total company revenues were $18.1 billion, an increase of 5 percent or 4 percent excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis.

接著說明第三季業績。公司合併營收為 181 億美元，成長 5%，若排除匯率影響則成長 4%。以下營收評論將以排除匯率影響（ex-exchange）為基礎。

In Oncology, sales of the KEYTRUDA family of products, which includes KEYTRUDA and KEYTRUDA QLEX, increased 6 percent to $8.6 billion. With global growth driven by strong uptake in earlier-stage cancers and continued robust demand for metastatic indications.

在腫瘤領域，KEYTRUDA 產品家族（包含 KEYTRUDA 與 KEYTRUDA QLEX）銷售額成長 6% 至 86 億美元。全球成長主要由早期癌症的強勁採用，以及對轉移性適應症持續旺盛的需求所帶動。

Key contributors to growth included strong utilization in tumors that primarily affect women, particularly cervical and breast cancers, as well as increased use of KEYTRUDA plus Padcev in urothelial cancer. We also saw continued uptake in earlier-stage head and neck cancer.

成長的主要貢獻因素包括：在主要影響女性的腫瘤（尤其是子宮頸癌與乳癌）中的強勁使用量，以及 KEYTRUDA 與 Padcev 聯合用於尿路上皮癌的使用增加。我們也看到在早期頭頸癌的採用持續提升。

As expected, the timing of US customer purchases last year created a headwind to growth, but this was largely offset by an increase in channel inventory, which we expect to unwind in the fourth quarter. Sales of KEYTRUDA QLEX were $830 million. We continue to see adoption increase, which supports our confidence in the trajectory of the product.

如預期，去年美國客戶採購時點對成長造成逆風，但大部分已被通路庫存增加所抵銷；我們預期該影響將在第四季回轉。KEYTRUDA QLEX 銷售額為 8.30 億美元。我們持續看到採用率上升，這也支持我們對該產品發展軌跡的信心。

In our broader Oncology portfolio, WELIREG sales increased 58 percent to $307 million, driven by increased use in previously treated patients and as adjuvant treatments for certain patients with renal cell carcinoma in the US, as well as continued uptake from ongoing launches in international markets.

在我們更廣泛的腫瘤產品組合中，WELIREG 銷售額成長 58% 至 3.07 億美元，主要受惠於在既往治療過的病患中使用增加，以及在美國作為特定腎細胞癌病患的輔助治療使用提升，並且國際市場持續上市推進帶來的採用成長。

In Vaccines and Infectious Diseases, GARDASIL sales were $2 billion, an increase of 14 percent. In the US, sales grew 18 percent, benefiting from a significant CDC purchase and price, while international markets increased 6 percent.

在疫苗與傳染病領域，GARDASIL 銷售額為 20 億美元，成長 14%。在美國，受惠於 CDC 的大額採購與價格因素，銷售成長 18%；國際市場則成長 6%。

In Pneumococcal, CAPVAXIVE sales were $263 million, an increase of 7 percent, driven by ongoing launches in certain international markets. In the US, sales declined 13 percent as increased market share was more than offset by lower adult pneumococcal vaccination rates.

在肺炎鏈球菌領域，CAPVAXIVE 銷售額為 2.63 億美元，成長 7%，主要由部分國際市場持續上市推動。在美國，儘管市占率提升，但被成人肺炎鏈球菌疫苗接種率下降所抵銷，銷售下滑 13%。

In RSV, ENFLONSIA sales of $187 million reflect seasonal demand and associated inventory build.

在 RSV 領域，ENFLONSIA 銷售額 1.87 億美元，反映季節性需求及相關庫存建立。

In Cardiometabolic and Respiratory, WINREVAIR continued its momentum with global sales of $694 million, an increase of 94 percent, reflecting strong demand from adults with pulmonary arterial hypertension, as well as a benefit from channel inventory. In the US, nearly 1,600 new patients received a prescription, approximately 30 percent of whom were on background therapies that did not include a prostacyclin. Outside the US, we continue to progress with ongoing launches.

在心臟代謝與呼吸領域，WINREVAIR 延續成長動能，全球銷售額為 6.94 億美元，成長 94%，反映肺動脈高壓成人患者的強勁需求，並受惠於通路庫存因素。在美國，近 1,600 名新患者獲得處方，其中約 30% 的患者正在使用不包含前列環素（prostacyclin）的背景治療。在美國以外地區，我們持續推進各地上市進度。

OHTUVAYRE sales were $184 million, reflecting continued demand from adults with COPD. Partially offset by a small headwind from the timing of specialty pharmacy purchases.

OHTUVAYRE 銷售額為 1.84 億美元，反映成人 COPD 患者的持續需求；但部分被專科藥局採購時點帶來的小幅逆風所抵銷。

While early, we are encouraged by the initial launch of LIPFENDRA. Prescription trends and physician feedback has been positive. Additionally, we have established programs to support access and affordability for eligible patients. As expected, broad access will take time to build, and we remain confident in the long-term opportunity for this important treatment option for adults with elevated LDL cholesterol.

雖然仍在早期階段，我們對 LIPFENDRA 的初期上市表現感到鼓舞。處方趨勢與醫師回饋皆為正向。此外，我們已建立相關計畫，以協助符合資格的患者取得用藥並提升可負擔性。如預期所示，廣泛的可近性需要時間建立；我們仍對此一重要治療選項在 LDL 膽固醇偏高成人族群的長期機會充滿信心。

Our Animal Health business delivered growth of 3 percent. Companion animal sales increased 6 percent driven by new product launches. Livestock sales grew 2 percent due to higher demand for poultry products.

我們的動物保健業務實現 3% 的成長。伴侶動物銷售成長 6%，主要由新產品上市帶動。畜牧業務銷售成長 2%，源於家禽產品需求提升。

I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin decreased slightly to 81.4 percent. Operating expenses increased 12 percent to $7.4 billion, reflecting increased investments to support our launches and advance our diverse early and late phase pipeline. This increase was partially offset by benefits from our ongoing multi-year optimization effort and the recognition of a portion of the external funding for sac-TMT development.

接下來我將帶各位看損益表其餘部分，我的評論將以非 GAAP 基礎說明。毛利率小幅下降至 81.4%。營業費用增加 12% 至 74 億美元，反映我們加大投資以支持產品上市，並推進多元的早期與後期研發管線。此增幅部分被我們持續多年的最佳化計畫所帶來的效益，以及 sac-TMT 開發外部資金部分認列所抵銷。

There was also a $400 million upfront charge related to the license agreement with SciBrunch compared with a $300 million business development charge a year ago. Other expense increased to $420 million, primarily reflecting financing costs related to recent business development transactions. Our tax rate was 10.9 percent, reflecting a benefit from certain discrete items. Taken together, earnings per share were $2.49, which includes a charge of $0.12 per share related to the SciBrunch license agreement.

此外，與 SciBrunch 授權協議相關的一次性預付費用為 4 億美元；相較之下，去年同期為 3 億美元的業務開發費用。其他費用增加至 4.20 億美元，主要反映近期業務開發交易相關的融資成本。我們的稅率為 10.9%，反映若干一次性項目的稅務利益。綜合而言，每股盈餘為 2.49 美元，其中包含與 SciBrunch 授權協議相關、每股 0.12 美元的費用。

Now turning to our 2026 non-GAAP guidance. We have narrowed the range and raised the midpoint of both our full-year revenue and EPS guidance. We now expect revenue to be between $66.8 billion and $67.3 billion, representing growth of 3 percent to 4 percent, including a positive impact from foreign exchange of approximately 1 percentage point using mid-October rates.

接著談 2026 年非 GAAP 財測指引。我們已縮小區間，並上調全年營收與 EPS 指引的中位數。我們目前預期營收介於 668 億至 673 億美元，代表成長 3% 至 4%；其中包含以 10 月中旬匯率計算、外匯帶來約 1 個百分點的正面影響。

Our gross margin assumption remains approximately 81 percent. Operating expenses are expected to be between $42.4 billion and $42.9 billion. Other expense is still expected to be approximately $1.4 billion. We now expect a full year tax rate between 32 percent and 33 percent. We assume approximately 2.48 billion shares outstanding.

我們對毛利率的假設仍約為 81%。預期營業費用介於 424 億至 429 億美元。其他費用仍預期約為 14 億美元。我們目前預期全年稅率介於 32% 至 33%。我們假設流通在外股數約 24.8 億股。

Taken together, we expect EPS of $2.77 to $2.82, including a positive impact from foreign exchange of approximately $0.15 using mid-October rates. This range also includes the SciBrunch charge.

綜合而言，我們預期 EPS 為 2.77 至 2.82 美元，其中包含以 10 月中旬匯率計算、外匯帶來約 0.15 美元的正面影響。此區間亦包含 SciBrunch 的相關費用。

As you consider your models, there are a few items to keep in mind. Third-quarter sales benefited by approximately $550 million from favorable purchase timing in the US. We expect the benefit related to KEYTRUDA and WINREVAIR to fully unwind in the fourth quarter, while the majority of the benefit to vaccines, primarily related to GARDASIL, is expected to unwind next year.

在各位建立模型時，有幾點需要留意。第三季銷售受惠於美國有利的採購時點，約帶來 5.50 億美元的助益。我們預期與 KEYTRUDA 與 WINREVAIR 相關的助益將在第四季完全回轉；而疫苗（主要與 GARDASIL 相關）的多數助益，預期將於明年回轉。

As we look forward to 2027, we recently noted an expectation for modest revenue growth. For KEYTRUDA, moderating growth reflects the success we have had in reaching the eligible patients as we now approach peak revenues for certain approved indications. Additionally, we expect the German market to be impacted by policy dynamics.

展望 2027 年，我們近期指出預期營收將呈現溫和成長。就 KEYTRUDA 而言，成長趨緩反映我們在觸及符合資格患者方面已取得成效，且部分已核准適應症正接近營收高峰。此外，我們預期德國市場將受到政策動態影響。

For BRIDION, we expect competition from multiple generics that have now entered the market. For vaccines, we are watching broader market trends given increased hesitancy and reduced utilization.

就 BRIDION 而言，我們預期將面臨多個已進入市場的學名藥競爭。就疫苗而言，鑑於猶豫情緒上升與使用率下降，我們正關注更廣泛的市場趨勢。

Finally, we also expect underlying operating expenses to increase at a mid to high single-digit rate, reflecting our conviction in the significant opportunity from our expanding pipeline and the growing portfolio of new product launches.

最後，我們也預期基礎營業費用將以中到高個位數的速度成長，反映我們對擴大中的研發管線所帶來重大機會，以及新產品上市組合持續增加的信心。

Now turning to capital allocation, where our priorities remain unchanged. We will continue to invest in value-creating opportunities that drive both near and long-term growth. We remain committed to the dividend with the goal of increasing it over time. Business development remains an important priority, and we retain financial flexibility within a strong investment-grade credit rating to pursue additional science-driven value-enhancing transactions. We remain on track for approximately $3 billion in share repurchases this year.

接著談資本配置，我們的優先順序維持不變。我們將持續投資於能創造價值的機會，以推動短期與長期成長。我們仍致力於股利政策，目標是隨時間逐步提高股利。業務開發仍是重要優先事項；在強健的投資級信用評等下，我們保有財務彈性，以進一步推動以科學為驅動、提升價值的交易。我們仍按計畫在今年進行約 30 億美元的庫藏股回購。

To conclude, as we head into the fourth quarter, we remain confident in the outlook for our business. Demand for our diverse portfolio of human and animal health products remains strong, and our recent launches are making increasingly meaningful contributions to growth. Our compelling, innovative portfolio of pipeline assets continues to progress, leaving us very well positioned to deliver outstanding value for patients, customers and shareholders now and into the future.

總結而言，邁入第四季之際，我們對業務前景仍具信心。我們多元的人用與動物保健產品組合需求依然強勁，近期上市產品對成長的貢獻也日益顯著。我們具吸引力且創新的研發管線資產組合持續推進，使我們在現在與未來都處於極佳位置，能為患者、客戶與股東創造卓越價值。

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

接下來，我想把電話會議交給 Dean。

Thank you, Caroline. Good morning, everyone. The third quarter was marked by a number of significant clinical and regulatory milestones. Today, I will provide updates in Oncology, Cardiometabolic and Respiratory, Immunology, and Ophthalmology. I will close by highlighting upcoming milestones.

謝謝你，Caroline。各位早安。第三季出現多項重要的臨床與監管里程碑。今天我將就腫瘤、心臟代謝與呼吸、免疫學，以及眼科領域提供最新進展。最後我會重點說明即將到來的里程碑。

Starting with oncology, as Rob noted, data from several pivotal studies were presented at ESMO, which exemplify our clinical development approach and reflect how KEYTRUDA is informing our pipeline progress. ESMO marked the first presentation of detailed Phase 3 findings from our expansive TroFuse development program for sac-TMT, our TROP2-directed ADC with a unique bifunctional linker.

先從腫瘤領域開始。如 Rob 所提，在 ESMO 上發表了多項關鍵性研究的數據，展現我們的臨床開發方法，也反映 KEYTRUDA 如何推動我們的研發管線進展。ESMO 亦是我們 sac-TMT 的大型 TroFuse 開發計畫中，首次對多項第三期（Phase 3）結果進行詳細發表；sac-TMT 為一款以 TROP2 為標的、具獨特雙功能連接子（bifunctional linker）的 ADC。

The TroFuse program is guided by a two-prong development strategy. First, we are moving with speed and rigor to establish early leadership in multiple disease and treatment settings. Many of these first-mover opportunities are in gynecologic cancers, where there remains significant unmet need.

TroFuse 計畫採取雙軌並進的開發策略。第一，我們以速度與嚴謹並重的方式推進，力求在多種疾病與治療情境中建立早期領先地位。其中許多先行者機會位於婦科癌症領域，該領域仍存在顯著未被滿足的醫療需求。

The TroFuse-005 study presented at ESMO evaluated sac-TMT in patients with endometrial cancer whose disease has progressed following platinum chemotherapy and anti-PD-L1 immunotherapy, demonstrating a remarkable near-seven-month improvement in median overall survival compared to chemotherapy alone.

在 ESMO 發表的 TroFuse-005 研究評估了 sac-TMT 用於子宮內膜癌患者（其疾病在接受鉑類化療與抗 PD-L1 免疫治療後仍進展），結果顯示相較於單純化療，其中位總生存期有顯著、接近 7 個月的改善。

Endometrial cancer is one of the few cancers with increasing incidence and mortality rates worldwide. These patients currently face a very poor prognosis, and we look forward to continuing to work with the FDA to deliver this potential new option as quickly as possible.

子宮內膜癌是全球少數發生率與死亡率仍在上升的癌症之一。這些患者目前面臨非常不佳的預後，我們期待持續與 FDA 合作，盡可能快速地提供這項潛在的新治療選擇。

Second, we are exploring the potential of sac-TMT in certain types of breast and lung cancers where we believe we can be differentiated. In first line, PD-L1 negative nonsquamous non-small cell lung cancer results from the OptiTROP-Lung06 study conducted by our partner, Kelun, showed a meaningful improvement in progression-free survival for sac-TMT plus KEYTRUDA over KEYTRUDA plus chemotherapy, raising the possibility that novel may improve upon the high bar set by KEYTRUDA plus chemotherapy.

第二，我們正在探索 sac-TMT 在某些乳癌與肺癌類型中的潛力，我們相信在這些領域可形成差異化。在第一線治療方面，由合作夥伴科倫（Kelun）進行的 OptiTROP-Lung06 研究顯示，於 PD-L1 陰性的非鱗狀非小細胞肺癌中，sac-TMT 合併 KEYTRUDA 相較於 KEYTRUDA 合併化療，在無惡化存活期方面有具意義的改善，並提出一種可能性：此新方案或可在 KEYTRUDA 合併化療所建立的高標準之上再進一步提升。

Our global TroFuse program includes various non-small cell lung cancer settings. We plan to investigate sac-TMT in combination with MK-2010, our PD-1/VEGF bispecific antibody in first-line non-small cell lung cancer. Engagement with the FDA has been productive, and we anticipate Phase 3 studies in this setting in the first half of 2027.

我們的全球 TroFuse 計畫涵蓋多種非小細胞肺癌治療情境。我們計畫在第一線非小細胞肺癌中，研究 sac-TMT 與 MK-2010（我們的 PD-1/VEGF 雙特異性抗體）之合併療法。與 FDA 的互動富有成效，我們預期在 2027 年上半年於此情境啟動第 3 期研究。

Now, turning to intismeran. Our deep understanding of tumor biology continues to inform the next generation of our oncology pipeline, including the development of an mRNA therapeutic cancer vaccine based on the unique mutational signature of a patient's tumor.

接著談 intismeran。我們對腫瘤生物學的深入理解，持續推動下一代腫瘤產品線的發展，包括開發一種以患者腫瘤獨特突變特徵為基礎的 mRNA 治療性癌症疫苗。

ESMO marked the unveiling of landmark results for intismeran, an investigational individualized neoantigen therapy developed in collaboration with Moderna plus KEYTRUDA as adjuvant therapy for melanoma. Results of the INTerpath-001 study demonstrated clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival for intismeran plus KEYTRUDA over standard-of-care KEYTRUDA in patients with completely resected stage 2b to 4 melanoma.

ESMO 公布了 intismeran 的里程碑式結果；intismeran 是與 Moderna 合作開發的研究性個人化新抗原療法，並與 KEYTRUDA 併用作為黑色素瘤的輔助治療。INTerpath-001 研究結果顯示，對於已完全切除之第 2b 期至第 4 期黑色素瘤患者，intismeran 合併 KEYTRUDA 相較於標準治療 KEYTRUDA，在無復發存活期與無遠端轉移存活期方面帶來具臨床意義的改善。

These results, building on the body of evidence from the Phase 2b study, strengthen our confidence in the curative potential of intismeran. When given in combination with KEYTRUDA. We are actively engaged with the FDA on regulatory submission.

這些結果在第 2b 期研究證據基礎上更進一步，強化了我們對 intismeran 治癒潛力的信心。當其與 KEYTRUDA 併用時。我們正積極與 FDA 就法規申請進行溝通。

Additionally, we are progressing a robust INTerpath clinical development program across a range of immune-sensitive tumors, including indications in earlier stages of the disease where KEYTRUDA has established efficacy.

此外，我們正推進一項強健的 INTerpath 臨床開發計畫，涵蓋多種對免疫治療敏感的腫瘤，包括疾病較早期、且 KEYTRUDA 已建立療效的適應症。

Phase 3 studies are ongoing in melanoma and non-small cell lung cancer, which are characterized by high mutational burden. Ongoing Phase 2 studies are also evaluating tumors with lower mutational burden, including certain bladder and renal cancers, to inform potential future expansion. I look forward to sharing further updates on these and other oncology programs.

黑色素瘤與非小細胞肺癌的第 3 期研究正在進行中，這兩者皆以高突變負荷為特徵。同時，進行中的第 2 期研究也在評估突變負荷較低的腫瘤，包括某些膀胱癌與腎癌，以作為未來可能擴展的依據。我期待就這些及其他腫瘤計畫分享更多更新。

Now to a few regulatory updates. Subcutaneous pembrolizumab and berahyaluronidase alfa was approved by regulatory authorities in Japan and China. In Europe, we received approval for KEYTRUDA-PADCEV as a perioperative treatment for resectable muscle-invasive bladder cancer. And in the US, the FDA approved WELIREG-LENVIMA for the treatment of patients with previously treated renal cell carcinoma.

接下來是幾項法規更新。皮下給藥的 pembrolizumab 與 berahyaluronidase alfa 已獲日本與中國主管機關核准。在歐洲，我們取得 KEYTRUDA-PADCEV 作為可切除之肌層浸潤性膀胱癌圍手術期治療的核准。在美國，FDA 核准 WELIREG-LENVIMA 用於治療既往接受治療之腎細胞癌患者。

Regarding ifinatamab deruxtecan, together with Daiichi Sankyo, we made the decision to withdraw the biologic license application seeking accelerated approval. Multiple studies of I-DXd are ongoing in small cell lung cancer, prostate cancer, and other tumor types.

關於 ifinatamab deruxtecan，我們與第一三共（Daiichi Sankyo）共同決定撤回尋求加速核准的生物製劑許可申請（BLA）。I-DXd 於小細胞肺癌、前列腺癌及其他腫瘤類型的多項研究仍在進行中。

Next, in cardiometabolic and respiratory, recently the FDA approved the label update for WINREVAIR incorporating results from the Phase 3 HYPERION study. Providing further evidence to support its use earlier in the treatment journey for adults with pulmonary arterial hypertension.

接著在心臟代謝與呼吸領域，FDA 近期核准 WINREVAIR 的標籤更新，納入第 3 期 HYPERION 研究結果。這提供了更多證據，支持其可在成人肺動脈高壓治療流程中更早使用。

With WINREVAIR, we introduced activin signaling inhibition, a novel mechanism targeting the underlying vascular, building on the findings from the Phase 2 CADENCE trial remodeling that drives disease progression [built]. We are taking an important step to extend the application of activin signaling inhibition beyond group 1 PAH.

透過 WINREVAIR，我們導入 activin 訊號抑制這一新穎機制，以針對血管的根本病理；此乃建立在第 2 期 CADENCE 試驗所揭示之血管重塑驅動疾病進展的發現之上 [built]。我們正採取重要一步，將 activin 訊號抑制的應用擴展至第 1 群 PAH 之外。

The upcoming Phase 3 Core study will evaluate patients with combined post and precapillary pulmonary hypertension associated with heart failure with preserved ejection fraction. This distinct population within group 2 pulmonary hypertension has similar vascular characteristics to PAH and no currently approved treatment options.

即將進行的第 3 期 Core 研究將評估一類患者：與射出分率保留之心衰竭相關、同時具有後毛細血管與前毛細血管成分的肺高壓。此為第 2 群肺高壓中的一個獨特族群，具有與 PAH 類似的血管特徵，且目前尚無核准的治療選項。

Next, in Immunology, last month at EADV, positive Phase 2b results were presented for tulisokibart in patients with hidradenitis suppurativa, making it the first anti-TL1A antibody to demonstrate positive clinical data in a dermatology indication. The study demonstrated promising clinical responses and encouraging safety profile. Based on these findings, we plan to advance tulisokibart into Phase 3 development in HS.

接著在免疫學領域，上月於 EADV 發表了 tulisokibart 用於化膿性汗腺炎（hidradenitis suppurativa）患者的正向第 2b 期結果，使其成為首個在皮膚科適應症中展現正向臨床數據的抗 TL1A 抗體。該研究顯示具前景的臨床反應與令人鼓舞的安全性概況。基於這些發現，我們計畫推進 tulisokibart 於 HS 的第 3 期開發。

Finally, to Ophthalmology, as Rob mentioned, earlier this month, results were presented from the Phase 2b/3 BRUNELLO study, the first of two pivotal studies evaluating remigromig, a novel Wnt agonist in adults with DME.

最後談眼科。如 Rob 所提，本月稍早公布了第 2b/3 期 BRUNELLO 研究結果；這是兩項關鍵性研究中的第一項，用於評估 remigromig（新型 Wnt 致效劑）在成人糖尿病黃斑水腫（DME）中的療效。

BRUNELLO achieved its primary endpoint with both doses of monthly remigromig, demonstrating non-inferior best-corrected visual acuity compared to monthly 0.5 milligram ranibizumab at one year. While anti-VEGF therapies have transformed the treatment of DME, disease activity persists in many patients, highlighting the need for new therapeutic options.

BRUNELLO 以每月給藥的兩種 remigromig 劑量皆達成主要終點，顯示在一年時的最佳矯正視力（BCVA）相較於每月 0.5 毫克 ranibizumab 具非劣效性。儘管抗 VEGF 療法已改變 DME 的治療格局，仍有許多患者的疾病活動度持續存在，凸顯對新治療選項的需求。

BRUNELLO provides clinical evidence that activation of the Wnt pathway can achieve non-inferior efficacy to an anti-VEGF agent in DME. If confirmed in the companion BAROLO trial, remigromig could introduce a promising new and orthogonal mechanism and help advance the field of ophthalmology towards therapeutic strategies involving multiple pathways.

BRUNELLO 提供臨床證據，顯示在 DME 中活化 Wnt 路徑可達到不劣於抗 VEGF 藥物的療效。若在配套的 BAROLO 試驗中獲得確認，remigromig 可能引入一項具前景且正交的新作用機制，並有助於推動眼科領域朝向涉及多重路徑的治療策略發展。

In closing, the breadth of these milestones reflects our progress in translating novel advances in the understanding of disease biology into potentially significant medicines across diverse therapeutic areas. Over the next 12 months, we anticipate several important clinical and regulatory milestones, including in Immunology for tulisokibart, we are compiling data from the Phase 3 ATLAS-UC study and expect to share the results in the near term.

總結而言，這些里程碑的廣度反映了我們在將對疾病生物學理解的創新進展，轉化為跨多個治療領域之潛在重大藥物方面所取得的進展。在未來 12 個月內，我們預期將迎來數項重要的臨床與法規里程碑；其中在免疫學方面，針對 tulisokibart，我們正在彙整第 3 期 ATLAS-UC 研究數據，並預期在近期分享結果。

In Ophthalmology, the readout of the BAROLO study of remigromig. In Cardiometabolic and Respiratory, the initiation of the Phase 3 Core study.

在眼科方面，將公布 remigromig 的 BAROLO 研究讀出結果。在心臟代謝與呼吸領域，將啟動第 3 期 Core 研究。

In Infectious Disease, anticipated regulatory filings for islatravir plus lenacapavir, the potential first once-weekly oral two-drug treatment regimen for HIV, data from the Phase 3 ANCHOR study evaluating MK-1406, our investigational long-acting and strain-agnostic antiviral designed to prevent influenza, and the data from the Phase 3 EXPrESSIVE program of our investigational once-monthly oral HIV PrEP option, alimatravir.

在感染性疾病方面，預期將就 islatravir 合併 lenacapavir 進行法規申請；該方案可能成為 HIV 首個每週一次口服的雙藥治療療程。此外，還包括第 3 期 ANCHOR 研究的數據（評估 MK-1406；此為我們的研究性長效、且不受病毒株影響的抗病毒藥物，旨在預防流感），以及我們研究性每月一次口服 HIV 暴露前預防（PrEP）選項 alimatravir 的第 3 期 EXPrESSIVE 計畫數據。

And finally, in Oncology, the potential approval of sac-TMT in endometrial cancer and additional Phase 3 readouts, the anticipated regulatory filing of intismeran and additional readouts in multiple other programs.

最後在腫瘤學方面，包括 sac-TMT 於子宮內膜癌的潛在核准與其他第 3 期讀出結果、intismeran 的預期法規申請，以及多個其他計畫的額外讀出結果。

And now, I will turn the call back to Peter.

現在，我將把電話交回給 Peter。

Thanks, Dean. Before we get started with Q&A, I'm very pleased to introduce Jannie Oosthuizen and Brian Foard who are with us this morning to help address questions. And as a reminder, Jannie serves as President of our Oncology business unit as well as MSD International; and Brian serves as President of our Specialty Pharma and Infectious Diseases business unit.

謝謝你，Dean。在開始問答之前，我很高興介紹今天早上與我們同在、協助回應問題的 Jannie Oosthuizen 與 Brian Foard。提醒一下，Jannie 擔任我們腫瘤事業部以及 MSD International 的總裁；Brian 則擔任我們專科藥品與傳染病事業部的總裁。

I'd also like to request that analysts limit themselves to a single question today so that we can get to as many different questioners as possible in the time that we have.

我也想請分析師今天每人僅限提一個問題，這樣我們才能在有限時間內讓更多不同的提問者發言。

So Julie, if you could please start the Q&A session. Thank you.

所以 Julie，麻煩你開始問答環節。謝謝。

(Operator Instructions) Chris Schott, JPMorgan.

(接線員指示) Chris Schott，摩根大通。

Great. Thanks so much for the question and congrats on all the progress. I guess my question, you recently made some comments on 2027, both top line and spend. And maybe just a two-part question. I'm just interested, do you feel that that's now appropriately reflected in consensus estimates?

太好了。非常感謝讓我提問，也恭喜你們取得的所有進展。我想我的問題是，你們最近對 2027 年（無論是營收端或支出端）發表了一些評論。也許分成兩個部分。我想了解的是，你們覺得這些內容現在是否已經在市場一致預估中得到適當反映？

And then just given the R&D spend we are seeing for the company in the near term as well as the longer-term pipeline derisking we've seen. Is it now fair to think about earnings growing off of this type of level as we move through the KEYTRUDA LOE, I guess, asked a different way, does this R&D spend effectively pull forward your trough earnings so we can think more about earnings growth from Merck as we look out to the 2030s?

另外，考量公司短期的研發支出水準，以及我們看到的長期管線去風險化進展。當我們走過 KEYTRUDA 專利到期（LOE）時，現在是否可以合理地認為獲利將從目前這種水準開始成長？換個方式問，這樣的研發支出是否等於把你們的獲利谷底提前，讓我們在展望 2030 年代時，可以更多地以默克的獲利成長來思考？

Chris, thank you for the question. First, if I can maybe provide everybody the headlines around our comments on 2027, and then I'll answer the specific questions.

Chris，謝謝你的問題。首先，我先為大家整理一下我們對 2027 年評論的重點，然後再回答你具體的問題。

For 2027, we see it as another year of investment as we invest behind our expansive pipeline and our new product launches to drive long-term growth. Specifically in 2027, we expect moderate top-line growth, and that's as a result of the strong contributions we expect from our new product launches as well as animal health that will be partially offset by more than $2 billion of headwinds as a result of generic competition and LOE, impacting BRIDION, JANUVIA family of products, as well as ADEMPAS.

對於 2027 年，我們視其為另一個投資年度，因為我們將持續投入於我們廣泛的研發管線以及新產品上市，以推動長期成長。具體而言，2027 年我們預期營收將呈現溫和成長，主要來自新產品上市以及動物保健的強勁貢獻；但這將部分被超過 20 億美元的不利因素所抵銷，該不利因素來自學名藥競爭與專利到期（LOE），影響 BRIDION、JANUVIA 產品家族以及 ADEMPAS。

We do expect KEYTRUDA to continue to be an important contributor to our overall revenues, although we do see growth moderating. And that's as we've reached peak penetration in a number of indications. While we also expect headwinds to price in our ex-US market, and we are watching the policy dynamics in Germany.

我們預期 KEYTRUDA 仍將是整體營收的重要貢獻者，儘管我們確實看到其成長將趨於放緩。這是因為在多個適應症上已達到滲透率高峰。同時，我們也預期在美國以外市場將面臨價格面的逆風，並且我們正在關注德國的政策動態。

From a vaccines perspective, we have seen a benefit of a CDC buy-in 2026 of approximately $250 million that will unwind in 2027. Now, as we look at the rest of the P&L, gross margin will increase given the roll-off of a royalty on KEYTRUDA. As you've noted, we expect expenses to increase because we are fully investing behind our strong pipeline as well as our launches. And we do expect slightly higher interest expense and a slightly higher tax rate.

在疫苗方面，我們在 2026 年因 CDC 一次性採購（buy-in）而受益約 2.5 億美元，該效益將在 2027 年回轉（unwind）。接著看損益表其他項目，由於 KEYTRUDA 的權利金到期（roll-off），毛利率將上升。正如你所提到的，我們預期費用將增加，因為我們將全力投資於強勁的研發管線以及產品上市。我們也預期利息費用略為提高，稅率也略為上升。

But all in all, 2027 marks a year of investment for strong growth in our future, which is all in part to drive our strategy of how our company grows beyond the KEYTRUDA LOE. Now, as we look at that, we see the KEYTRUDA LOE as really more of a hill on the overall revenues of our company, as we will, in short order, then return to strong growth.

總體而言，2027 年標誌著為未來強勁成長而投資的一年，這也是我們推動公司在 KEYTRUDA 專利到期（LOE）之後仍能成長之策略的一部分。就此而言，我們將 KEYTRUDA 的 LOE 視為公司整體營收曲線上的一座「小丘」，因為在短時間內我們就會回到強勁成長。

As we look at consensus estimates for 2027, there are a number of different estimates from the different analysts and some have incorporated the messaging that we've given, many have not yet. So hopefully, this will provide clarity as to our expectations for 2027.

至於 2027 年的一致預估，來自不同分析師的估計有不少差異；有些已納入我們傳達的訊息，但也有許多尚未。因此，希望這些說明能讓大家更清楚我們對 2027 年的預期。

And as we look at earnings as we move forward, we do expect to see our company have earnings as we move towards the LOE period grow. We do expect, as I've noted, a shallow dip in revenues in the initial period post the price setting through IRA and the LOE but to quickly return to growth. And we would expect the earnings profile to probably mirror that given the expansive pipeline that we have and the continued studies that we will be doing and supporting, as well as the launches that are coming through year over year.

而在展望未來獲利時，我們確實預期公司在走向 LOE 期間，獲利仍會成長。如我所提到的，我們預期在 IRA 下的定價設定以及 LOE 之後的初期，營收會出現幅度不深的下滑，但會很快回到成長。考量我們廣泛的研發管線、我們將持續進行並支持的研究，以及逐年推出的產品上市，我們預期獲利走勢大致也會呈現相同的型態。

So headline, confident in our future, confident in our pipeline that will drive long-term growth and patient benefit and enable us to offset over time the KEYTRUDA LOE.

總結來說，我們對未來有信心，對能驅動長期成長與病患受益、並使我們隨時間推移得以抵銷 KEYTRUDA 專利到期（LOE）影響的研發管線也有信心。

Great. Thank you, Chris. Next question, please, Julie.

很好。謝謝你，Chris。Julie，請進行下一個問題。

Vamil Divan, Guggenheim Securities.

Vamil Divan，Guggenheim Securities。

Thanks for taking the question and congrats on the progress with the pipeline. Maybe just on WINREVAIR, if I could ask a couple. One of you could quickly just quantify the one-time benefit you saw specifically for WINREVAIR this quarter. I know you kind of grouped it into the $550 million overall for the pharma business.

謝謝讓我提問，也恭喜你們在研發管線上的進展。我想針對 WINREVAIR 問幾個問題。你們其中一位能否快速量化一下本季你們在 WINREVAIR 上看到的一次性效益？我知道你們把它與製藥事業整體的 5.5 億美元一起合併說明了。

And then, Dean, I specifically wanted to ask you on the CHORUS trial, we did go through the listing there. Could you discuss how it's similar or different than what you did with the Phase 2 CADENCE trial in terms of the endpoint, in terms of the inclusion criteria, just to give us a sense of how the patients and the study will compare to each other?

另外，Dean，我特別想問 CHORUS 試驗。我們確實看過試驗登錄資訊。你能否談談它在終點指標、納入標準等方面，與你們在第二期 CADENCE 試驗所做的設計有何相同或不同，讓我們了解兩者的病人族群與研究將如何相互對照？

Thank you, Vamil, for the question. In terms of the timing benefits that we saw in the quarter, if I may give the full picture inclusive of WINREVAIR so that we have it out there for all. We had a benefit in the third quarter of $550 million as a result of the timing of purchases.

謝謝你，Vamil，提出這個問題。關於本季我們看到的時點性效益，如果可以的話，我想把包含 WINREVAIR 在內的完整情況一併說明，讓大家都清楚。第三季我們因採購時點而有 5.5 億美元的效益。

$200 million of that relates to KEYTRUDA, which we will expect to unwind in full in the fourth quarter. $50 million relates to WINREVAIR, which we expect to unwind in the fourth quarter. A further $300 million relates to our vaccines business, which is predominantly GARDASIL. We expect $50 million to unwind in the fourth quarter and the remaining $250 million to unwind in 2027.

其中 2 億美元與 KEYTRUDA 有關，我們預期第四季將全部回轉（unwind）。5,000 萬美元與 WINREVAIR 有關，我們預期也會在第四季回轉。另外 3 億美元與我們的疫苗事業有關，主要是 GARDASIL。我們預期其中 5,000 萬美元將在第四季回轉，其餘 2.5 億美元將在 2027 年回轉。

Yeah, Vamil, thank you very much for the questions. I'll just answer it in two parts. The first is I just want to call out for PAH group 1, not group 2, that the field is increasingly moving to a concept of, with activin signaling inhibitor, the potential of remission. And you've seen that in the European guidelines that have come out, and we're hopeful that the similar sort of standard will take. This is really important because it suggests similar to ACE inhibition in left heart failure, that in this right heart failure with PAH group 1, that physicians in the field can think differently about the treatment paradigm.

是的，Vamil，非常感謝你的問題。我分兩部分回答。第一，我想特別指出，針對 PAH 第 1 群（不是第 2 群），在該領域中，對於使用 activin 訊號抑制劑達到「緩解（remission）」的可能性，正越來越朝這個概念發展。你已經在近期發布的歐洲指引中看到這點，我們也希望類似的標準能被採納。這非常重要，因為它意味著，類似於左心衰竭中的 ACE 抑制，在 PAH 第 1 群的右心衰竭情境下，臨床醫師可以用不同的方式思考治療典範。

The reason I want to bring that up is that you've asked me now about group 2, which is a heart failure study. We have the CADENCE study. And what we're going to be doing in the CHORUS study, I just wanted to be pretty clear, we're not expanding the patient population in any substantive way. There are details in relationship to how we're going to execute on the trial. But we really think that this patient population that was seen in the CADENCE has an incredibly high unmet need, there's no approved treatment. It's really poor prognosis, and it's also an orphan indication.

我之所以先提這點，是因為你現在問的是第 2 群，也就是一項心衰竭研究。我們有 CADENCE 研究。而在 CHORUS 研究中我們將要做的事情，我想說得很清楚：我們並不會以任何實質方式擴大病人族群。在試驗執行方式上會有一些細節差異。但我們確實認為，在 CADENCE 中所見到的這個病人族群存在極高的未被滿足醫療需求，且目前沒有核准的治療。其預後非常差，同時這也是一個罕見疾病（orphan）適應症。

And so from the CADENCE, we met primary endpoints, reduction in PVR and important secondary endpoints. And we're going to initiate the Phase 3 course this year with a 0.3 milligram per kilogram dose and with time to clinical worsening in the endpoints. And we expect that this will be a very attractive trial for patients with group 2 pulmonary hypertension.

因此，從 CADENCE 試驗來看，我們達成了主要終點——PVR 的降低——以及重要的次要終點。我們將在今年以 0.3 毫克/公斤的劑量啟動第 3 期試驗，並將「至臨床惡化時間」納入終點。我們預期這將會是一項對第 2 群肺高壓患者非常具吸引力的試驗。

Great. Thanks, Vamal. Next question, please.

很好。謝謝你，Vamal。請下一題。

Michael Yee, UBS.

Michael Yee，瑞銀（UBS）。

Maybe, Dean, if I could just follow-up on, obviously, the very busy ESMO conference. Maybe here you could offer a view about the fact that you have greater confidence in China studies being further replicated across all of your global TroFuse studies. And since I think we've discussed lung cancer enough, maybe you could just comment on where the one or two other sac-TMT indications you think are most notable and that you may not be paying attention to.

Dean，也許我可以追問一下，顯然 ESMO 大會非常忙碌。也許你可以談談，你對中國研究結果能在你們所有全球 TroFuse 研究中進一步被複現這件事，為何更有信心。另外，既然我想我們對肺癌已經討論得夠多了，也許你可以評論一下，除了肺癌之外，你認為另外一到兩個最值得關注、但可能尚未被充分注意的 sac-TMT 適應症在哪裡。

Okay, so I had a hard time hearing, but I think the gist of your question relates to the TROP2 ADC that we have, our sac-TMT. And I would just highlight what was said in the remarks, which is we've always had a two-part strategy.

好的，我剛剛有點聽不清楚，但我想你問題的重點是我們的 TROP2 ADC，也就是 sac-TMT。我想強調我們在發言中提到的內容：我們一直採取兩部分的策略。

The first part is we had recognized that when we got into this field that there were two TROP2 ADCs. That were ahead of us, but we were actually surprised that they did not move quickly to indications outside of breast and lung, and we thought that there would be an enormous opportunity to do so. And you see that in our clinical trials as we move very fast outside of lung and breast. There are trials that we have in lung and breast, but we've moved very fast outside of that. And this most recent TroFuse-005 is an evidence of that.

第一部分是，我們進入這個領域時就認知到，當時有兩個 TROP2 ADC 走在我們前面。但我們其實很驚訝它們沒有快速拓展到乳癌與肺癌以外的適應症，而我們認為這裡存在巨大的機會。你也可以從我們的臨床試驗看到，我們非常快速地把布局延伸到肺癌與乳癌之外。我們在肺癌與乳癌確實有試驗，但我們也很快地往其他領域推進。而最近的 TroFuse-005 就是這一點的證明。

The reason why that's important is if you look at that TroFuse-005 as a proof point, I would just call your attention to, I think it was a presentation, I think in 2025 or 2026, with MK-2870-001 or Kelun 264-01. That's the Phase 1/2 endometrial cohort. That was the informative information for us looking at Chinese data that allowed us to figure out how to translate that in TroFuse-005.

之所以重要，是因為如果你把 TroFuse-005 當作一個驗證點，我想提醒你注意，我記得是在 2025 或 2026 年的一個報告，關於 MK-2870-001 或科倫 264-01。那是第 1/2 期的子宮內膜癌隊列。那份中國數據對我們很有啟發，讓我們得以思考如何把它轉化並應用到 TroFuse-005。

So the bottom line is that experience working closely with Kelun, it isn't like you're going to translate them exactly, but it gives you the signal as to how. Might translate it into the global. So that gives us confidence that the Kelun data is a really important signal for us and that we are confident that we can translate into the global trials. And we hope to replicate that in other indications outside of lung and breast. But clearly, as Marjorie and Eliav have talked recently, we plan to go quite aggressively in lung.

所以結論是，與科倫密切合作的經驗，並不是說你會把它們一模一樣地照搬，但它會提供一個訊號，告訴你該如何——把它轉化到全球試驗中。因此，這讓我們有信心：科倫的數據對我們而言是一個非常重要的訊號，而且我們有信心能把它轉化到全球試驗。我們也希望在肺癌與乳癌以外的其他適應症中複現這一點。不過很明顯地，正如 Marjorie 和 Eliav 最近談到的，我們計畫在肺癌領域相當積極地推進。

Great. Thanks, Mike. Next question, please.

很好。謝謝你，Mike。請下一題。

Courtney Breen, Bernstein.

Courtney Breen，Bernstein。

Hi, Merck team. Thanks so much for taking the question today. I just wanted to zoom into the subcutaneous or KEYTRUDA QLEX litigation that is ongoing around the hyaluronidase component of that product. We're seeing kind of obviously reports out of Europe and kind of infringement claims that are being made.

嗨，默沙東團隊。非常感謝今天讓我提問。我想聚焦在皮下劑型或 KEYTRUDA QLEX 的訴訟議題，目前正圍繞該產品中的透明質酸酶（hyaluronidase）成分進行。我們看到歐洲那邊有一些報導，以及提出的侵權主張。

Can you just contextualize where we're at in Europe relative to the US? Is this a definitive call? Are there likely paths to moving back towards the launch in these European countries? And is there any risk in the US as we move forward given that the path and the intentions and the litigation that is ongoing?

你們能否說明一下，相較於美國，目前在歐洲的情況進展到哪裡？這是否已是定案？在這些歐洲國家，是否可能有途徑讓產品重新朝上市方向推進？另外，考量目前的路徑、意圖以及仍在進行的訴訟，未來在美國推進時是否存在任何風險？

Maybe I'll start, Courtney, and then I'll turn it over to Jannie.

Courtney，也許我先回答，然後再交給 Jannie。

Overall, I just want to emphasize, we feel very strongly that we have IP that gives us freedom to operate as it relates to QLEX. That's why we actually pursued action against others in the field to ensure we could do that. So nothing has changed to our confidence we see long term. The injunction you're seeing in Europe is just an injunction until the hearing is held. It doesn't speak to the merits of our belief. We continue to feel very good that we have a position both in the US and in Europe.

整體而言，我想強調，我們非常堅信我們擁有與 QLEX 相關、足以讓我們具備自由實施（freedom to operate）的智慧財產權。這也是為什麼我們實際上對該領域的其他方採取行動，以確保我們能做到這一點。因此，我們對長期的信心沒有任何改變。你們在歐洲看到的禁制令，只是在聽證會舉行前的暫時性禁制令。它並不代表對我們主張的實體理由作出判斷。我們仍然非常有信心，無論在美國或歐洲，我們都具備有利的立場。

But maybe I'll let Jannie speak specifically to the implications of Europe and how we see that potentially resolving.

不過，關於歐洲的影響以及我們認為可能如何解決，我讓 Jannie 來具體說明。

Thank you, Rob, and thank you for the question, Courtney. In relation to the US, as Rob said, we feel really strong about our position in the US. And in fact, you saw the number $830 million of QLEX in the quarter or KEYTRUDA QLEX subcu in the quarter, which is the majority is the US. Since we received the permanent J-Code on April 1, it's really been a very positive trajectory and we feel good about the objective of getting to that 30 percent to 40 percent adoption in the United States by the end of 2027.

謝謝你，Rob，也謝謝你的提問，Courtney。就美國而言，如 Rob 所說，我們對在美國的立場非常有信心。事實上，你也看到本季 QLEX（或 KEYTRUDA QLEX 皮下劑型）的金額是 8.30 億美元，其中大部分來自美國。自從我們在 4 月 1 日取得永久性的 J-Code 之後，整體走勢非常正向；我們也對在 2027 年底前於美國達到 30% 到 40% 的採用率目標感到樂觀。

So the United States, we're really on a good path. In terms of ex-US, we've always talked about a range of adoption from high-adoption markets to much lower adoption. In our high-adoption markets, which is the UK, Canada, Austria, we're actually able to supply, we're waiting for the launch in Canada, but these are the high-adoption markets and we actually see a high level of adoption in the UK already, so that is also very positive and not challenged by the injunction out of The Netherlands.

所以在美國，我們確實走在一條很好的路徑上。至於美國以外（ex-US），我們一直談到採用率會有一個區間，從高採用市場到採用率低得多的市場都有。在我們的高採用市場——英國、加拿大、奧地利——我們其實能夠供貨；加拿大方面我們正等待上市，但這些都是高採用市場。而我們在英國已經看到很高的採用程度，因此也非常正面，且不受荷蘭禁制令的影響。

In terms of Japan and China, also no issue from a supply and launch perspective and we're waiting to launch in those two markets where there's significant volume and we have an ambition to get a high level of subcutaneous use.

至於日本與中國，在供應與上市層面也沒有問題；我們正等待在這兩個具有顯著量體的市場上市，而且我們的目標是在皮下使用率方面達到較高水準。

In Europe, where the Dutch ruling is valid for now, as Rob said, we do not agree with the Dutch court and we will continue to work to overturn this. So for now, we will not supply in Italy, Denmark, the Netherlands, France, Belgium, and Ireland. These in general are smaller volume markets, so it's immaterial in terms of our overall volume of subcutaneous. But again, given that we have longer IP. If we would turn this decision positive, we will have time to get back and make this convenient formulation available to patients in these markets as well.

在歐洲，目前荷蘭的裁定暫時有效；如 Rob 所說，我們不同意荷蘭法院的判決，並將持續努力推翻該裁定。因此，目前我們不會在義大利、丹麥、荷蘭、法國、比利時與愛爾蘭供貨。整體而言，這些多屬於較小量體市場，因此就我們皮下劑型的整體量體而言影響不大。但再次強調，鑑於我們擁有更長期的 IP 保護，如果我們能讓這項決定朝正面方向翻轉，我們仍有時間回到這些市場，讓患者也能使用這種更便利的劑型。

So overall, we feel we're in a really good place in terms of subcutaneous adoption and trajectory of where we want to be.

總體而言，就皮下劑型的採用率與我們希望達成的成長軌跡來看，我們認為目前處於非常良好的位置。

Excellent. Thank you, Courtney.

非常好。謝謝你，Courtney。

Next question please.

請下一題。

Akash Tewari, Jefferies.

Akash Tewari，Jefferies。

Hey, thanks so much. It looks like the primary endpoint for your KANDLELIT-004 first-line NSCLC trial was changed from PFS and OS to PFS only back in September, which cut your target enrollment and moved up your primary completion.

嗨，謝謝你們。看起來你們的 KANDLELIT-004 一線 NSCLC 試驗的主要終點在 9 月時從 PFS 與 OS 改為僅 PFS，這也降低了你們的目標入組人數，並提前了主要完成時間。

Do you think this is a part of a larger stance that maybe the FDA is taking here where hitting on OS is important, but not gating toward initial filing? And how could that maybe apply to the design for your first-line sac-TMT PD-1/VEGF bispecific antibody trial you're aiming to start first half of next year?

您認為這是否是 FDA 在此採取的更大立場的一部分，也就是說強調 OS（總生存期）很重要，但不會作為初次申報的門檻（gating）？以及這可能會如何影響您計畫於明年上半年啟動的第一線 sac‑TMT PD‑1/VEGF 雙特異性抗體試驗之設計？

Yeah, thank you very much for actually calling out calderasib. I just step back so that other people who are listening understand. That's our KRAS G12C inhibitor, and we think that MK-1084 or calderasib is a very important molecule. It has the profile that we wish that any RAS molecule would have. It's extremely potent, it's extremely selective, and it can be well combined, for example, with KEYTRUDA in the situation and with something like cetuximab in the CRC, and we've seen really strong data.

是的，非常感謝您特別點名 calderasib。我先退一步說明，讓其他正在收聽的人也能理解。那是我們的 KRAS G12C 抑制劑，我們認為 MK‑1084（或 calderasib）是一個非常重要的分子。它具備我們希望任何 RAS 分子都能擁有的特性。它效力極強、選擇性極高，而且可很好地進行聯合用藥，例如在相關情境下與 KEYTRUDA 併用，以及在結直腸癌（CRC）中與 cetuximab 這類藥物併用，我們也看到了非常強勁的數據。

In relationship to our moving forward in relationship to this, I think part of that is discussions and feedback with the FDA. I do believe that all of those endpoints will be important. PFS, OS eventually will all be important. But yes, we are moving with speed and rigor to get this calderasib in first-line lung with KEYTRUDA, but especially subcutaneous KEYTRUDA QLEX moving quite fast.

關於我們如何推進這件事，我認為其中一部分來自與 FDA 的討論與回饋。我確實相信所有這些終點都會很重要。PFS（無惡化存活期）、OS（總生存期）最終都會很重要。

I should also emphasize that there is a difference of how we might have a philosophy in terms of clinical development versus others in this space. And for us, what's really important is, again, this is a place where we're thinking about KEYNOTE-189, KEYNOTE-407, and asking ourselves, well, how do we displace that with those patients who have a KRAS G12C mutation, which is the dominant mutation for RAS in that patient population. And our strategy is not to add it on top of pembrolizumab plus chemo, but to use a pembrolizumab plus that inhibitor by itself without the chemo so that we can create a chemo-free option for patients.

我也要強調，我們在臨床開發理念上，可能與這個領域的其他公司有所不同。對我們而言，真正重要的是——再次強調——這裡我們會想到 KEYNOTE‑189、KEYNOTE‑407，並問自己：對於帶有 KRAS G12C 突變的患者（這是該患者族群中 RAS 最主要的突變），我們要如何取代那樣的治療方案？而我們的策略不是把它加在 pembrolizumab 加化療之上，而是僅使用 pembrolizumab 加上該抑制劑、不使用化療，從而為患者創造一個無化療（chemo‑free）的選項。

Great. Thanks, Akash.

很好。謝謝你，Akash。

Next question, please.

下一個問題，請。

Daina Graybosch, Leerink Partners.

Daina Graybosch，Leerink Partners。

You might have a follow-up just right on RAS. You have two other RAS assets, one that you licensed out of China. I wonder if you could just step back, Dean, and talk about how you're thinking about the full portfolio across indications and combinations beyond calderasib assets.

我想就 RAS 再追問一下。你們還有另外兩個 RAS 資產，其中一個是從中國授權引進的。我想請您退一步談談，Dean，您如何看待整體產品組合在不同適應症與聯合用藥上的布局，除了 calderasib 之外的那些資產。

Yeah, so thank you very much for that question. I think it shares a lot of similarities. So our interest in, for example, a KRAS G12D is whether we could, for example, replicate what we see in lung with a KRAS G12D in a very similar strategy. But as I said, we're using calderasib and 1084 as a way to sort of measure what we do.

好的，非常感謝這個問題。我認為它們有很多相似之處。例如，我們對 KRAS G12D 的興趣在於：我們是否能以非常類似的策略，在肺癌中用 KRAS G12D 複製我們所看到的成果。但如我所說，我們把 calderasib 和 1084 作為某種衡量標準，來評估我們要怎麼做。

The other place that we have, we think, quite good data is calderasib in relationship to CRC, especially in first-line CRC. Now in calderasib in CRC, KRAS G12C is a really important target, but it's the minority. It's the distinct minority of RAS mutations. KRAS G12D is the sort of more dominant mutation.

另外一個我們認為數據相當不錯的領域，是 calderasib 在結直腸癌（CRC）上的表現，尤其是在第一線 CRC。

And so our hope is that this KRAS G12D, that we should have important clinical data in the next year or so will replicate what we've done in KRAS G12C in, for example, lung and CRC. And also, we would clearly look to see what it does in pancreas. But our focus has been how do we use calderasib and how do we look at the other isoforms of RAS or the other subtypes of RAS and how do we recreate what we believe is a really good profile for KRAS G12C and how do we replicate it for the other subtypes.

因此，我們希望這個 KRAS G12D——我們預期在未來一年左右會有重要的臨床數據——能夠複製我們在 KRAS G12C 上於例如肺癌與 CRC 所做出的成果。同時，我們也會明確地觀察它在胰臟方面的表現。

Great. Next question, please.

很好。下一個問題，請。

Mohit Bansal, Wells Fargo.

Mohit Bansal，Wells Fargo。

Great. Thank you very much for taking my question and congrats on all the progress. So just trying to speak to IBD or tulisokibart. So it does look like the field of IBD is moving towards combinations as we try to push remission rates higher in earlier lines of settings. So in that backdrop, how are you thinking about building a combination strategy around TL1A? Do you think it is strategically important to have all the complementary mechanisms in-house? Or would you be comfortable partnering with some established market -- marketed products at this point to find the best combination?

很好。非常感謝讓我提問，也恭喜你們取得的所有進展。我想談談 IBD 或 tulisokibart。看起來 IBD 領域正朝向聯合療法發展，因為我們希望在更早線別的治療情境中把緩解率推得更高。在這樣的背景下，你們如何思考圍繞 TL1A 建立聯合策略？你們是否認為策略上必須把所有互補機制都放在內部（in‑house）？或者你們是否願意在此階段與一些已在市場上的成熟產品合作，以找到最佳的聯合方案？

Thank you. So you broke up a little bit, but I'll just answer in a more general way because I think you're asking a question that's a broader question in immunology, how do you think about combinations and the such.

謝謝。你剛剛的聲音有點斷斷續續，但我會用更一般性的方式回答，因為我認為你問的是免疫學領域更廣泛的問題：如何看待聯合療法等等。

Combinations have been done quite a lot in immunology. They were done back, I think, in the 2018 -- I can't remember, 2020 range, and those combinations have not generally given that much benefit. So you do not see that combination strategy play out. I do have to give our credit to a company who's more recently advanced sort of combinations, and we'll see how that data comes through.

在免疫學領域，聯合療法其實已經做過很多。我記得大概在 2018 年——我不太確定，可能到 2020 年那段期間——做過不少聯合，而這些聯合通常並沒有帶來那麼多的效益。因此你並沒有看到聯合策略普遍地真正落地。不過我也必須肯定一家近來推進某些聯合策略的公司，我們會看看那些數據最後會如何呈現。

But the bottom line is, combinations could be important. We believe combinations, for example, in oncology, are really important. We think combinations of different mechanisms in ophthalmology is really important, and combinations could be really important throughout immunology.

但歸根結底，聯合療法可能很重要。我們相信例如在腫瘤學中，聯合療法非常重要。我們認為在眼科領域，不同機制的聯合也非常重要；而在免疫學的各個領域，聯合療法也可能非常重要。

However, I think each indication and each sort of compounds that are there will have to play out and we'll to all do as a field the work to determine how important and how effective combination therapies are throughout immunology and the different indications.

然而，我認為每個適應症、以及每一類化合物的情況都需要逐步驗證；作為整個領域，我們都必須做功課，去判斷在免疫學及不同適應症中，聯合療法到底有多重要、以及有多有效。

And maybe I'd just add because I think you had a business development angle to that question as well. So starting with -- we have several assets coming through early development in-house. So we actually have a range of internal assets that could be potential combination partners, but we also remain open on the business development front, both in terms of products and development as well as commercialized products.

另外我也補充一下，因為我認為你的問題也包含商務開發（business development）的角度。首先——我們有數個資產正在內部早期開發中。因此我們其實有一系列內部資產，可能成為聯合用藥的合作夥伴；但同時我們在商務開發面也保持開放，不論是開發中產品，或是已商業化的產品。

So we're looking at all fronts and remain confident that we are positioned to move depending on how we see the field. Evolve, as Dean said.

所以我們在各個面向都在評估，並且仍然有信心：我們已經處於一個可以依據我們對領域發展的觀察而推進的有利位置。如 Dean 所說，隨著領域演進（evolve）。

Thank you. Next question, please, Julie.

謝謝。Julie，下一個問題，請。

Steve Scala, TD Cowen.

Steve Scala，TD Cowen。

Thank you very much. I'm curious what LIPFENDRA sales were in the quarter and what percent of prescriptions are free drug? Despite lots of competitors, LIPITOR generated over $800 million in its first year on the market, and I can't think of any reasons why LIPFENDRA shouldn't do at least that well, and I'm wondering if you agree.

非常感謝。我想了解本季度 LIPFENDRA 的銷售額是多少，以及處方中有多少百分比是免費用藥（free drug）？儘管競爭者眾多，LIPITOR 在上市第一年仍創造超過 8 億美元的銷售額；我想不出有什麼理由 LIPFENDRA 不應該至少做到同樣的表現，因此想請問你是否同意。

So appreciate the question. We are, as we highlighted in the opening comments as Caroline laid out, we are focused on affordability and access and the way we structured this. So we are using couponing and other means. I'll let Brian speak to it.

非常感謝這個問題。正如我們在開場評論中強調、Caroline 也已說明的，我們聚焦在可負擔性與可近性，以及我們為此所採取的架構方式。因此我們正在使用折價券等方式，以及其他手段。我讓 Brian 來補充說明。

I think what you're going to see right now is the script date is quite strong. We're not going to get specifics on our revenue forecast at the moment, but I'll let Brian maybe give comments so she can get a sense of how we're seeing the scripts evolve.

我認為你們現在會看到的是，處方量（script）日期的表現相當強勁。我們目前不會提供營收預測的具體細節，但我會請 Brian 也許補充一些評論，讓你能感受到我們如何看待處方量的演變。

Yes, Steve, thank you so much for your question. It sounds like you have similar excitement as we do in this particular space as well. We are seeing really early positive uptake, actually, and I'll speak to a couple of the numbers.

是的，Steve，非常感謝你的提問。聽起來你在這個領域也跟我們一樣感到興奮。我們確實看到非常早期的正向採用動能，我會談幾個數字。

In spite of the fact that we know that this is a marketplace, that there is a significant amount of inertia, and we said that it will be a gradual ascent as the prescriptions come in. But I'll give you a couple of metrics to think about.

儘管我們知道這是一個市場，有相當程度的慣性，而且我們也說過，隨著處方進來會是逐步上升。不過我給你幾個指標作為參考。

So in the third quarter, we saw more than 11,000 prescriptions. And this is coming from over 6,500 prescribers. And those prescribers are broken down. We're actually seeing not just in cardiologists but also in general practitioners, which is really encouraging.

第三季我們看到超過 11,000 張處方。而這些處方來自超過 6,500 位開立處方者。這些開立處方者的組成也很值得注意。我們不只在心臟科醫師中看到，也在一般科醫師中看到，這非常令人鼓舞。

But probably what's even a little bit more encouraging than that is we're seeing then signs that actually expanding beyond the PCSK9 marketplace. The vast majority of prescriptions are coming from patients on other background lipid-lowering therapies rather than switches off of injectable PCSK9s, which is exactly what we had hoped for.

但可能更令人鼓舞的是，我們看到一些跡象顯示，實際上正在擴展到 PCSK9 市場之外。絕大多數處方來自於原本就在使用其他背景降脂治療的病人，而不是從可注射的 PCSK9 藥物轉換過來，這正是我們所希望看到的。

Now, keep in mind. I think as Rob had mentioned, we have sampling and coupon programs that are out there today that will affect revenue in the short-term. But we're also actively in discussions with payers, and the whole goal there is to get as rapid access as possible. Commercial, we expect, as we had mentioned before, large coverage of the access in the commercial space in the 2027 timeframe. And then for Medicare, it's actually in the 2028 timeframe as well.

另外請記住。我想如 Rob 提到的，我們目前有提供試用（sampling）與折價券方案，短期內會影響營收。但我們也正積極與支付方（payers）討論，整體目標是盡可能快速取得給付與可近性。在商業保險方面，如同先前提到的，我們預期在 2027 年左右於商業端取得大範圍的給付覆蓋。至於 Medicare，則大約是在 2028 年的時間點。

Now our teams are working really diligently to expedite that and bring it forward. But as we said before, this is a place that there is natural inertia in the marketplace. And so we're cautious about the early uptake, but early signs are positive for us and we see this again, as we said, as a meaningful growth driver for us in the future, a multibillion opportunity.

我們的團隊正非常努力地加速這個進程並把時程往前拉。但如同我們之前所說，這個市場本來就存在自然的慣性。因此我們對早期採用保持審慎，但早期訊號對我們而言是正向的；而且我們再次強調，我們認為這會是未來重要的成長驅動因素，是一個數十億美元規模的機會。

Great. Thank you, Steve.

很好。謝謝你，Steve。

Next question, please, Julie.

Julie，請下一題。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

Morning, guys. Thanks for taking my question. Dean, I was thinking about the recently presented melanoma data for the cancer vaccine. And my question is, how does that efficacy break down for patients that had a lower number of neoantigens, and perhaps even more importantly, patients that did not have a major driver mutation like NRAS or BRAF, et cetera? I'm just trying to think through the implications for the upcoming RCC readout.

早安，各位。謝謝讓我提問。Dean，我在想最近發表的癌症疫苗黑色素瘤數據。我的問題是：對於新抗原（neoantigens）數量較少的病人，療效拆分（efficacy breakdown）是怎麼樣？以及或許更重要的是，對於沒有像 NRAS 或 BRAF 等主要驅動突變（driver mutation）的病人，療效表現如何？我只是想推敲這對即將公布的 RCC 讀出（readout）有何意涵。

Yeah, so I want to be a little bit cautious of getting ahead of the data that was presented and the data that we are examining and will likely provide in some time. I think some people have said in the next year or so. So I don't want to get ahead of that.

是的，所以我想稍微謹慎一點，不要超前於已呈現的數據，以及我們正在檢視、並可能在一段時間後提供的數據。我想有些人說可能在接下來一年左右。所以我不想在那之前就先做過多解讀。

But I would just emphasize, and if you don't mind, I'm going to take a little bit of time here in relationship to that, which is there was a press conference or investor meeting that Moderna sponsored. And I would just call out the two really important experts that they had there, which was Georgina Long, who was important for this trial; and Antonio Ribas.

但我想強調的是——如果你不介意，我在這裡會花一點時間談相關背景——Moderna 曾主辦一場記者會或投資人會議。我想特別點出他們邀請的兩位非常重要的專家：一位是 Georgina Long，她在這項試驗中扮演重要角色；另一位是 Antonio Ribas。

And the reason I want to call that out is I've seen some reports about melanoma and all of this. I just want to call out that Georgina Long was a senior investigator of NADINA; and Antonio Ribas was the senior author of SWOG 1801. And I would just quote Antoni Ribas saying, this is a landmark in cancer drug development.

我之所以要特別提，是因為我看到一些關於黑色素瘤及相關議題的報告。我想指出的是：Georgina Long 是 NADINA 的資深研究者（senior investigator）；而 Antonio Ribas 是 SWOG 1801 的資深作者（senior author）。我引用 Antonio Ribas 的話：這是癌症藥物開發的一個里程碑。

And so we are eager to present that to the FDA. And I do think the data as interpreted by those people who are scientific leaders is that this is a landmark study in its own right. And because of that, we would expect that, or we would hope, I should say, that upon approval that the NCCN guidelines would potentially define this as a new standard of care.

因此我們也很期待把這些資料提交給 FDA。而且我確實認為，從那些科學領袖的解讀來看，這本身就是一項具里程碑意義的研究。

So that's the melanoma question. The other question is, melanoma itself. You can have a spectrum of TMB within melanoma, but in general, the spectrum of TMB in melanoma is just shifted. It's just shifted totally in favor of being high TMB. So, I would be a little bit cautious for me to over-interpret any data in, for example, lower TMB in melanoma as a signal for RCC.

我認為根本的問題在於，你所看到的是——至少在我們的經驗中——免疫檢查點抑制劑與免疫腫瘤（IO）藥物不只是我們的，甚至例如 IL-2，在 RCC 這個腫瘤類型上是有效的；RCC 一直是你所謂「免疫反應性」（immunoresponsive）較好的腫瘤。我認為 TMB 很重要，但我也認為 TMB 並不是決定免疫反應性的唯一因素。如果你採取這樣的觀點，這就是我看待我們即將進行的 RCC 研究的方式。

I think the fundamental issue is that what you've seen is that, at least in our hand, checkpoint inhibitors and IO agents, not just ours, but, for example, IL-2, have worked that has been a place that RCC has been a good tumor in relationship to what you would call immunoresponsive. And I think TMB is important, but I also think TMB is not the only determinant of immune responsiveness. And if you take that view, that's how I look at our upcoming study with RCC.

我不太確定，在黑色素瘤內去細分（parsing）TMB，是否會讓我對 RCC 的信心增加或降低。

I'm not so sure that parsing the TMB within melanoma will give me any increased or decreased confidence in relationship to RCC.

Thank you, Umer.

謝謝你，Umer。

Next question, please.

請下一題。

Asad Haider, Goldman Sachs.

Asad Haider，Goldman Sachs。

Great. Thanks for taking the question. A lot of mine have been asked, but maybe one big picture zooming out for you, Rob, just given the developments over the course of this year, it would be great to get any updated framing on how you see the $70 billion revenue opportunity you've talked about by the mid-2030s. You've obviously had a lot of pipeline success over the course of the year. The company continues to transform its portfolio. Things are moving in the right direction to de-risk that number.

很好。謝謝讓我提問。我很多問題已經被問過了，但也許我想從更宏觀的角度請教你，Rob：考量今年以來的各項進展，能否更新一下你對於你曾提到在 2030 年代中期可達 700 億美元營收機會的看法與框架？你們今年在研發管線上顯然有很多成功。公司也持續轉型其產品組合。各項進展正朝著降低該數字風險的方向前進。

So maybe just double-click on the pushes and pulls that have occurred to influence that and remind us on what wasn't incorporated into that framing and what surprised you to the positive side and what's still underappreciated.

所以也許可以再深入一點談談，哪些推力與拉力（pushes and pulls）影響了這個判斷，並提醒我們：當初那個框架中哪些內容尚未納入？有哪些正向驚喜？以及哪些部分仍被低估？

Yeah, no, I appreciate that. So overall, my -- the pride I have in what we've done as a company and how we're moving forward, given the fact that we've seen so much of our clinical data readout positive to date. Obviously, these are studies, so every card is a new card and you have to wait until the next card is overturned.

是的，我很感謝這個問題。整體而言，我——對於我們公司所做的事情以及我們如何向前推進——感到非常自豪，尤其是考量到截至目前我們看到許多臨床數據讀出（readout）都是正向的。當然，這些都是研究試驗，所以每翻一張牌都是新的一張牌，你必須等到下一張牌被翻開。

But that said, what we've seen so far gives me great confidence and increased confidence in that $70 billion. And as such, as we've indicated, we expect now to be raising that number, not only because what we're seeing confidence in what we have, but what wasn't included, which is, I think, part of your question.

不過話說回來，我們目前所看到的一切，讓我對那 700 億美元更有信心、信心也進一步提升。因此，如同我們先前所指出的，我們現在預期會上調那個數字；不僅因為我們對既有內容更有把握，也因為還有先前未納入的部分——我想這也是你問題的一部分。

And I would just remind you that when we gave that number, we did not have the Terns acquisition included. That is going to be addition to that number. In addition to that, we really put nothing in for the PD-1/VEGF, which now given what you've heard coming out of several different conferences and other meetings. We have growing confidence in that as a combination agent for us as we think about that with sac-TMT and with everything else. So a lot of excitement there. Sac-TMT itself, it's probably going to have broader indications as we look forward, given the fact that we're kicking off new studies there as well.

我也想提醒各位，當我們提出那個數字時，並未把 Terns 的收購納入。那將會是在該數字之上的增量。此外，我們在 PD-1/VEGF 上幾乎沒有納入任何貢獻；但就你們在數個不同會議與其他場合所聽到的最新進展來看，我們對其作為組合用藥的信心正在提升，並且會把它與 sac-TMT 以及其他所有項目一併納入思考。因此那裡有很多令人振奮之處。而 sac-TMT 本身，隨著我們也將啟動新的研究，往前看它很可能會有更廣泛的適應症。

And then lastly and importantly, intismeran, we had intismeran was in our initial expectation, but it was based on a product profile that frankly, given the data we have seen. We actually see a better commercial profile than what we expected. So the targeted product profile now is stronger and so that in and of itself would drive some upside.

最後也很重要的是 intismeran。我們最初的預期中確實包含 intismeran，但那是基於一個產品特性（product profile）；坦白說，依據我們目前看到的數據，我們實際上看到的商業化特性比原先預期更好。因此目前的目標產品特性更強，而這本身就會帶來一些上行空間。

So as we look across the portfolio, I feel very good about where we are and our ability to navigate the KEYTRUDA LOE. And importantly, we have a lot more catalysts coming as you look out over the next 12 to 24 months. So I think we need to continue to see those cards, but I feel very good about where we're sitting right now.

因此，從整體產品組合來看，我對我們目前的位置以及我們因應 KEYTRUDA 專利到期（LOE）的能力感到非常有信心。更重要的是，展望未來 12 到 24 個月，我們還會有更多催化劑出現。所以我認為我們需要持續看到這些牌面逐步翻開，但我對我們現在所處的位置感覺非常好。

Great. Thank you.

很好。謝謝。

Next question, please.

下一個問題，請。

Terence Flynn, Morgan Stanley.

摩根士丹利（Morgan Stanley）的 Terence Flynn。

Great. Thanks for taking the question. Maybe a follow-up to a prior one. Dean, I recognize your comments on melanoma and what it means for other tumor types. What about the implications of the INT PDAC poster that were presented at ESMO? We could just help put that into context for us and the importance of that as you think about other tumor types.

很好。謝謝讓我提問。也許接續前面的一個問題。Dean，我理解你對黑色素瘤以及其對其他腫瘤類型意涵的評論。那麼，在 ESMO 上發表的 INT PDAC 海報，其意涵又是什麼？能否請你幫我們把它放在脈絡中，並談談當你思考其他腫瘤類型時，這件事的重要性。

I did not enjoy the balmy weather in Spain, and I had Eliav and Marjorie out there. But I listened very carefully to some of the questions that were placed before them and also to our Moderna colleagues.

我沒有去享受西班牙宜人的天氣，而是讓 Eliav 和 Marjorie 去了。但我非常仔細地聽了大家向他們提出的一些問題，也聽了我們 Moderna 同事的回應。

So, I will just answer just in a more broad way. We have like four Phase 3 INTerpaths and we have five Phase 2s. There is a strategy to broaden it from melanoma to lung to bladder to RCC within the conservative point of view in relationship of where we know that those are immunoresponsive and specifically our checkpoint inhibitor responsive and specifically, our KEYTRUDA responsive and specifically, KEYTRUDA responsive in early stage.

所以，我會用比較宏觀的方式來回答。我們大概有四個第三期（Phase 3）的 INTerpath 試驗，還有五個第二期（Phase 2）。我們的策略是在相對保守的觀點下，將範圍從黑色素瘤擴展到肺癌、膀胱癌以及腎細胞癌（RCC），因為我們知道這些腫瘤對免疫治療有反應，特別是對檢查點抑制劑有反應，特別是對 KEYTRUDA 有反應，而且更具體地說，是在早期病程中對 KEYTRUDA 有反應。

When you look at our trials, I think it's very important because people have asked different questions. And I'll get to your pancreatic study, but we have laid it out that what could it do without an IO agent? And so you see in stage 1 non-small cell lung cancer, in INTerpath-014, that's what we're doing. In NMIBC, we're asking what happens in metastatic, that's first-line melanoma, that's INTerpath-012, asking in the absence of checkpoint inhibitor, we're asking. And first-line squamous non-small cell lung cancer INTerpath-013.

當你看我們的試驗設計時，我認為這點非常重要，因為大家問了不同的問題。我會談到你的胰臟研究，但我們已經把框架鋪陳出來：如果沒有 IO 藥物，它能做到什麼？因此你會看到在第一期非小細胞肺癌的 INTerpath-014，我們就是在做這件事。在 NMIBC，我們在問轉移性情境下會如何；在一線黑色素瘤，也就是 INTerpath-012，我們在問在沒有檢查點抑制劑的情況下會如何。以及一線鱗狀非小細胞肺癌的 INTerpath-013。

Specifically, your question of something that's IO non-responsive, that's not where we've placed most of our Phase 3, Phase 2, but there are data from our other people moving field that suggests that we should look at it. And that's -- we're testing whether or not with a checkpoint inhibitor or even IO non-responsive tumors, how to think about it.

就你特別問到的、屬於 IO 不反應的情境而言，這並不是我們大多數第三期、第二期試驗所聚焦的地方，但從其他同業推進的領域資料來看，顯示我們應該去研究它。而這就是——我們正在測試：不論是搭配檢查點抑制劑，甚至是在 IO 不反應的腫瘤中，該如何思考這件事。

But I also just want to make sure that everyone understands that there were questions in relationship to perioperative and all of this for melanoma. We also have questions of perioperative. We're not asking that question so much in melanoma, but we're asking that in non-small cell lung cancer, which is INTerpath-009.

但我也想確保大家理解：有人就黑色素瘤的圍手術期（perioperative）以及相關議題提出問題。我們也有圍手術期的問題要回答。我們在黑色素瘤上不太是在問這個問題，但我們在非小細胞肺癌上有在問，也就是 INTerpath-009。

So I just want to give a sense that some of the questions that were asked that I've seen, we don't have every trial, but I hope that gives you a general sense of we have melanoma and we're trying to broaden the scope, and we're trying to do the experiments that will teach us not just what tumor type, but how to think about the indication and the mechanism of action.

所以我只是想讓大家感受到：我看到的一些被提出的問題，我們不可能每一個問題都有對應的試驗，但希望這能讓你對整體方向有個概念——我們有黑色素瘤，並且正嘗試擴大範圍；同時我們也在做一些實驗，來教會我們的不只是「是哪一種腫瘤類型」，也包括如何思考適應症以及作用機轉。

Great. Thank you, Terence.

很好。謝謝你，Terence。

And we know it's a busy day for all of you, and we're at the top of the hour, so we're going to end it there. Thank you all for the very good questions, and please follow-up with the IR team for any follow-ups.

我們知道今天大家都很忙，而現在也到整點了，所以我們就到此結束。謝謝各位提出非常好的問題；若有任何後續問題，請與投資人關係（IR）團隊聯繫。

Thank you for your participation. You may disconnect at this time.

感謝各位的參與。您現在可以斷線。