默克藥廠 (MRK) 2024 Q2 法說會逐字稿

內容摘要

默克公司 2024 年第二季電話會議強調了公司​​的財務表現和研發策略重點。他們報告稱,腫瘤學和疫苗等關鍵領域成長強勁,提高了收入指引。高層討論了 GARDASIL 疫苗在中國市場的挑戰和機遇,表達了對公司前景的信心以及對創新和拯救生命的承諾。

提供了有關管道開發和業務策略的最新信息,重點是正在進行的臨床試驗和未來的成長機會。高層強調,他們致力於尋求與其投資組合和技能相匹配的科學機會,並展示了他們對研究和開發的強烈關注。

總體而言,電話會議展示​​了默克在 2024 年第二季度的強勁業績以及他們對未來的戰略願景。在整個討論過程中,他們對創新、拯救生命以及在腫瘤學和疫苗等關鍵領域尋求成長機會的關注顯而易見。該公司對持續臨床試驗、商業策略和科學機會的承諾凸顯了他們致力於推動醫療保健產業取得成功並產生積極影響。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Thank you for standing by. Welcome to the Merck & Company Q2 sales and earnings conference call. (Operator Instructions)

    謝謝你的支持。歡迎參加默克公司第二季銷售和收益電話會議。 (操作員說明)

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

    我現在想將電話轉給投資者關係資深副總裁 Peter Dannenbaum 先生。先生,您可以開始了。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Thank you, Brad, and good morning, everyone. Welcome to Merck's second-quarter 2024 conference call. 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 Merck Research Labs.

    謝謝布拉德,大家早安。歡迎參加默克 2024 年第二季電話會議。董事長兼執行長 Rob Davis 將在今天的電話會議上發表演說;卡洛琳‧利奇菲爾德,財務長;以及默克研究實驗室總裁 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, and that we have excluded these 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 業績中有一些項目,例如收購相關費用、重組成本和某些其他項目,並且我們已將這些項目從非 GAAP 業績中排除。我們的新聞稿中有一個和解。

  • 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 Merck'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.

    我還要提醒您,我們今天發表的一些聲明可能被視為 1995 年美國私人證券訴訟改革法案安全港條款含義內的前瞻性聲明。的管理層面臨重大風險和不確定性。如果我們的基本假設被證明不準確或存在不確定性,實際結果可能與前瞻性陳述中提出的結果有重大差異。

  • Our SEC filings, including Item 1A in the 2023 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 undertakes no obligation to publicly update any forward-looking statements.

    我們向SEC 提交的文件(包括2023 年10-K 中的第1A 項)確定了某些風險因素和警示性聲明,這些因素可能導致公司的實際結果與我們今天上午做出的任何前瞻性聲明中的預測存在重大差異。默克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 Merck's website.

    在今天的電話會議中,我們的演講者準備好的演講將附有幻燈片演示。這些幻燈片以及收益發布、今天準備好的評論以及我們向 SEC 提交的文件均發佈在默克網站的投資者關係部分。

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

    有了這個,我想把電話轉給羅布。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

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

    謝謝彼得。早安,感謝您參加今天的電話會議。

  • Our business is demonstrating strong momentum as we exit the first half of the year. We remain guided by our purpose of harnessing the power of leading-edge science to save and improve lives around the world. Our ambitious and dedicated teams are working tirelessly to reach more patients with our broad commercial portfolio and advance our deep pipeline with the goal of delivering future innovations that solve for additional unmet medical needs.

    隨著上半年的結束,我們的業務表現出強勁的勢頭。我們始終遵循利用尖端科學的力量拯救和改善世界各地生命的目標。我們雄心勃勃、敬業的團隊正在不懈地努力,透過我們廣泛的商業產品組合接觸到更多患者,並推進我們的深層產品線,目標是提供未來的創新,解決更多未滿足的醫療需求。

  • Through excellent scientific, commercial, and operational execution, we're achieving significant milestones for our company and for patients. This quarter, we're proud to have successfully launched WINREVAIR, which has introduced a novel mechanism to treat adults suffering with pulmonary arterial hypertension. We're also pleased by the recent FDA approval of CAPVAXIVE, the first approved pneumococcal conjugate vaccine specifically designed for adults, as well as the subsequent ACIP recommendation. Both of these important innovations demonstrate our unwavering commitment to creating value for patients and shareholders.

    透過出色的科學、商業和營運執行,我們正在為公司和患者實現重要的里程碑。本季度,我們很自豪地成功推出了 WINREVAIR,它引入了一種治療患有肺動脈高壓的成年人的新機制。我們也對最近 FDA 批准 CAPVAXIVE(第一個批准的專為成人設計的肺炎球菌結合疫苗)以及隨後的 ACIP 建議感到高興。這兩項重要的創新都體現了我們堅定不移地致力於為患者和股東創造價值的承諾。

  • And we remain committed to the execution of strategic business development to further augment our pipeline. We recently announced and have now closed the acquisition of EyeBio, which expands our effort in ophthalmology and brings to Merck a novel, late-phase candidate for the treatment of retinal diseases. This promising new mechanism adds another substantial potential commercial opportunity to our expanding pipeline in an area of significant unmet medical need.

    我們仍然致力於執行策略性業務發展,以進一步擴大我們的管道。我們最近宣布並現已完成對 EyeBio 的收購,這擴大了我們在眼科領域的努力,並為默克帶來了一種治療視網膜疾病的新型後期候選藥物。這種有前景的新機制為我們在醫療需求未被滿足的領域不斷擴大的產品線增加了另一個巨大的潛在商業機會。

  • In addition, our animal health business closed the acquisition of Elanco's aqua business, which establishes Merck as a leader in this important production animal category.

    此外,我們的動物保健業務完成了對 Elanco 水產業務的收購,這使默克成為這一重要生產動物類別的領導者。

  • Three years ago, I was honored to step into the role of CEO, and it remains my top priority to uphold and build on Merck's legacy as a premier science-driven, patient-focused biopharmaceutical company. At that time, I affirmed Merck's strategic commitment to the research and development of innovative medicines and vaccines as a source of long-term value creation. I communicated our intention to be appropriately aggressive in making the necessary investments to both advance our broad internal pipeline and augment it with the best external science through business development.

    三年前,我很榮幸擔任首席執行官,而我的首要任務仍然是維護和發揚默克作為一家一流的科學驅動、以患者為中心的生物製藥公司的傳統。當時,我肯定了默克對創新藥物和疫苗研發的策略承諾,將其作為長期價值創造的來源。我表達了我們的意圖,即適當積極地進行必要的投資,以推進我們廣泛的內部管道,並透過業務發展用最好的外部科學來增強它。

  • Since then, we've made substantial progress in expanding and evolving our pipeline for the benefit of future patients. We have the potential to bring as many new drugs to market in the next five years, as we launched over the last ten years, across a greater number of therapeutic areas and modalities and with a significant proportion having blockbuster-plus potential.

    從那時起,我們在擴大和發展我們的產品線以造福未來患者方面取得了實質進展。我們有潛力在未來五年內向市場推出與過去十年一樣多的新藥,涵蓋更多的治療領域和模式,其中很大一部分具有重磅炸彈的潛力。

  • We've made tremendous progress building on our past successes, enabling the creation of a sustainable engine that will drive future innovations for patients. And we continue to leverage our scientific prowess to identify new therapeutic targets where we can add value through our expertise in clinical development and regulatory affairs and our global commercial scale.

    在過去成功的基礎上,我們取得了巨大的進步,創造了一個可持續的引擎,為患者推動未來的創新。我們繼續利用我們的科學實力來確定新的治療靶點,透過我們在臨床開發和監管事務方面的專業知識以及我們的全球商業規模來增加價值。

  • I'm also proud of the substantial improvements we've made across our sustainability focus areas. We're reaching more people with our medicines and vaccines across a greater number of countries globally than ever before and doing so with a dedicated, highly talented, and diverse employee base.

    我也為我們在永續發展重點領域的重大進步感到自豪。我們透過敬業、高素質且多元化的員工基礎,在全球比以往更多的國家/地區為更多的人提供我們的藥物和疫苗。

  • Finally, we're driving increased innovation and productivity through widespread integration of data, digital, and analytics in all areas of our business. Going forward, I'm committed to ensuring our actions remain aligned with our strategy, and I'm confident that we are well positioned to deliver value to patients and shareholders long into the future.

    最後,我們透過在所有業務領域廣泛整合數據、數位化和分析來推動創新和生產力的提高。展望未來,我致力於確保我們的行動與我們的策略保持一致,我相信我們有能力在未來很長一段時間內為患者和股東創造價值。

  • Turning to our second-quarter results, we achieved strong growth, reflecting continued demand across our broad portfolio, which is reflected in our updated full-year guidance, which Caroline will speak to in just a moment.

    談到我們第二季度的業績,我們實現了強勁的成長,反映出我們廣泛的投資組合的持續需求,這反映在我們更新的全年指導中,卡羅琳稍後將談到這一點。

  • Turning to our broader research efforts and new launches, in cardiometabolic, we've seen very favorable reception by physicians, patients, and payors to the availability of WINREVAIR. While still early, the US launch has gone very well, in line with our own high expectations. We've deployed a focused, customer-centric rare disease model and are pleased to see an increasing number of prescriptions being written and patients obtaining access.

    談到我們在心臟代謝領域的更廣泛的研究工作和新產品的推出,我們看到醫生、患者和付款人對 WINREVAIR 的可用性感到非常滿意。雖然還為時過早,但美國的發布進展順利,符合我們自己的高期望。我們部署了一個專注的、以客戶為中心的罕見疾病模型,並很高興看到越來越多的處方被開出並且患者獲得使用權。

  • We've also received a positive CHMP opinion and look forward to potential regulatory approval in Europe in the near future. We continue to see a tremendous opportunity to positively impact the lives of patients living with this devastating disease.

    我們也收到了 CHMP 的積極意見,並期待在不久的將來獲得歐洲監管部門的批准。我們繼續看到巨大的機會來積極影響患有這種毀滅性疾病的患者的生活。

  • In vaccines, we continue to bring forward innovations for both adults and children. We are proud of the recent FDA approval of CAPVAXIVE for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults and the unanimous ACIP recommendation. Given its compelling clinical profile, we expect that CAPVAXIVE will achieve a majority market share in the adult setting.

    在疫苗方面,我們繼續為成人和兒童帶來創新。我們對 FDA 最近批准 CAPVAXIVE 用於預防成人侵襲性肺炎球菌疾病和肺炎球菌肺炎以及 ACIP 的一致推薦感到自豪。鑑於其引人注目的臨床概況,我們預計 CAPVAXIVE 將在成人環境中獲得大部分市場份額。

  • We were also pleased to announce positive topline results from the Phase 2b/3 clinical trial for clesrovimab, our investigational monoclonal antibody for the prevention of RSV in infants, and we are moving swiftly to bring this important option to market.

    我們也很高興地宣布clesrovimab 的2b/3 期臨床試驗取得了積極的頂線結果,clesrovimab 是我們用於預防嬰兒RSV 的研究性單株抗體,我們正在迅速採取行動,將這一重要選擇推向市場。

  • Finally, at our ASCO investor event, we highlighted the significant broadening of our oncology pipeline and the progress we've made in building on the success of KEYTRUDA. We presented data for multiple novel candidates, demonstrating our commitment to advancing standards of care and maintaining leadership over the long term. As a company, we remain highly focused and continue to work with urgency to bring forward these innovations and others for the patients we serve.

    最後,在我們的 ASCO 投資者活動中,我們強調了我們的腫瘤產品線的顯著拓寬以及我們在 KEYTRUDA 成功的基礎上取得的進展。我們提供了多個新候選人的數據,證明了我們對提高護理標準和長期保持領先地位的承諾。作為一家公司,我們仍然高度專注,並繼續緊迫地工作,為我們服務的患者帶來這些創新和其他創新。

  • In summary, I want to again recognize the tremendous efforts of our global team. Together, we've made significant progress across our diverse pipeline and portfolio. As a company, we've been advancing science for the benefit of patients for over 130 years, and I'm confident that Merck is well positioned to deliver value to patients, shareholders, and to all of our stakeholders well into the future.

    總之,我想再次認可我們全球團隊的巨大努力。我們共同在多元化的產品線和產品組合中取得了重大進展。作為一家公司,130 多年來,我們一直致力於推動科學進步,造福患者,我相信默克有能力在未來為患者、股東和所有利益相關者創造價值。

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

    這樣,我就把電話轉給卡洛琳。

  • Caroline Litchfield - Chief Financial Officer, Executive Vice President

    Caroline Litchfield - Chief Financial Officer, Executive Vice President

  • Thank you, Rob. Good morning.

    謝謝你,羅布。早安.

  • As Rob noted, we delivered another excellent quarter, with growth driven by robust global demand across our innovative portfolio. These results are enabled by the excellent execution of our teams and reinforce the conviction we have in our science-led strategy. We remain confident in our ability to continue 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.

    正如羅布所指出的那樣,我們又交付了一個出色的季度,成長是由我們的創新產品組合強勁的全球需求所推動的。這些成果得益於我們團隊的優秀執行力,並增強了我們對科學主導策略的信念。我們對在短期內持續取得強勁成果的能力充滿信心,並致力於對引人注目的科學進行嚴格的投資,為患者、客戶和股東帶來長期價值。

  • Now turning to our second-quarter results, total company revenues were $16.1 billion, an increase of 7%, or 11% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis. Our human health business sustained its momentum with double-digit growth of 11%, primarily driven by oncology. Our animal health business also delivered solid performance, with sales increasing 6%, driven by growth in livestock products.

    現在來看我們第二季的業績,公司總營收為 161 億美元,成長 7%,排除外匯影響則成長 11%。以下收入評論將以換算為基礎。我們的人類健康業務保持成長勢頭,實現 11% 的兩位數成長,這主要是由腫瘤學推動的。我們的動物保健業務也取得了穩健的業績,在畜牧產品成長的推動下,銷售額成長了 6%。

  • Turning to the performance of our key brands, in oncology, sales of KEYTRUDA grew 21% to $7.3 billion, driven by increased uptake from earlier stage cancers and continued strong global demand from metastatic indications. In the US, KEYTRUDA grew across a broad range of tumors.

    談到我們主要品牌的表現,在腫瘤學領域,由於早期癌症的使用增加以及轉移適應症的全球持續強勁需求,KEYTRUDA 的銷售額增長了 21% 至 73 億美元。在美國,KEYTRUDA 在多種腫瘤中生長。

  • In the earlier-stage setting, the increase was largely attributable to uptake from KEYNOTE-671 and KEYNOTE-091 in non-small cell lung cancer. KEYTRUDA has now achieved market leadership in the neoadjuvant and adjuvant settings, building on its existing leadership position as adjuvant therapy.

    在早期階段,這種增加主要歸因於非小細胞肺癌中 KEYNOTE-671 和 KEYNOTE-091 的吸收。 KEYTRUDA 憑藉其作為輔助治療的現有領導地位,現已在新輔助和輔助治療領域取得市場領導地位。

  • In metastatic disease, we saw continued strong uptake in first-line advanced urothelial cancer following the recent launch of KEYNOTE-A39. KEYTRUDA plus Padcev has now surpassed platinum chemotherapy-based regimens in new patient starts.

    在轉移性疾病方面,繼最近推出 KEYNOTE-A39 後,我們看到第一線晚期尿路上皮癌的使用持續強勁。 KEYTRUDA 加 Padcev 現已在新患者入組中超過了基於鉑類化療的治療方案。

  • Outside the US, KEYTRUDA growth was driven by increased use in certain earlier-stage cancers, including high-risk, early-stage triple negative breast cancer and intermediate-high or high-risk renal cell carcinoma, as well as continued strong demand from patients with metastatic disease. Inflation-related price increases, consistent with market practice in Argentina, also contributed to growth.

    在美國以外,KEYTRUDA 的成長是由某些早期癌症(包括高風險、早期三陰性乳癌和中高或高風險腎細胞癌)的使用增加以及患者持續強勁的需求推動的患有轉移性疾病。與阿根廷市場慣例一致的與通貨膨脹相關的價格上漲也促進了成長。

  • Alliance revenue from Lynparza and Lenvima each grew 4%. WELIREG sales more than doubled to $126 million, driven by increased uptake in certain patients with previously treated advanced renal cell carcinoma.

    Lynparza 和 Lenvima 的聯盟收入分別成長 4%。由於某些先前接受過治療的晚期腎細胞癌患者的使用量增加,WELIREG 的銷售額增長了一倍多,達到 1.26 億美元。

  • Our vaccines portfolio delivered solid growth. GARDASIL sales increased 4% to $2.5 billion. In the US, sales benefitted from price, as well as demand, and favorable CDC purchasing patterns. Outside the US, higher demand across many international markets was partially offset by the timing of shipments to China.

    我們的疫苗產品組合實現了穩健成長。 GARDASIL 銷售額成長 4%,達到 25 億美元。在美國,銷售受益於價格、需求以及 CDC 有利的採購模式。在美國以外,許多國際市場的較高需求被運往中國的時間部分抵消。

  • In pneumococcal, VAXNEUVANCE sales increased 16% to $189 million. Growth was driven by ongoing launches in international markets.

    在肺炎球菌領域,VAXNEUVANCE 銷售額成長 16%,達到 1.89 億美元。成長是由國際市場上不斷推出的產品所推動的。

  • As Rob noted, we are very excited by the opportunity to positively impact the lives of adult patients with pulmonary arterial hypertension following the recent US launch of WINREVAIR. Recall, we received FDA approval on March 26, with the first patients receiving therapy about one month later.

    正如 Rob 指出的那樣,繼最近在美國推出 WINREVAIR 後,我們非常高興有機會對成年肺動脈高壓患者的生活產生積極影響。回想一下,我們於 3 月 26 日獲得 FDA 批准,大約一個月後第一批患者接受了治療。

  • Initial patient and physician feedback has been favorable, and we recorded $70 million of sales in the quarter. We estimate that approximately 40% of sales were attributable to doses administered to patients, with the remainder due to distributors building inventory in support of increasing demand.

    患者和醫生的初步回饋非常積極,本季我們的銷售額達到 7000 萬美元。我們估計,大約 40% 的銷售額來自給患者服用的劑量,其餘部分來自分銷商建立庫存以支持不斷增長的需求。

  • The launch is off to a strong start. As of the end of June, more than 2,000 patients received a prescription for WINREVAIR. Our experience to date with those prescriptions would suggest that approximately 75% to 80% will receive commercial product. Of those, more than 1,000 patients started treatment in the quarter, largely reflecting prescriptions written in April and May, as it currently takes approximately one month to complete the steps necessary to commence therapy.

    這次發射有一個好的開始。截至6月底,已有2,000多名患者收到了WINREVAIR的處方。我們迄今為止使用這些處方的經驗表明,大約 75% 至 80% 將接受商業產品。其中,超過 1,000 名患者在本季度開始接受治療,主要反映了 4 月和 5 月開出的處方,因為目前完成開始治療所需的步驟大約需要一個月的時間。

  • More than 500 physicians have written at least one prescription, with many looking to gain experience with the product as they prioritize treating the most advanced patients who are in greatest need of additional therapy. Most prescribers are from either large academic centers or larger private practices.

    超過 500 名醫生至少開出了一份處方,其中許多人希望獲得該產品的經驗,因為他們優先治療最需要額外治療的最晚期患者。大多數處方醫生來自大型學術中心或大型私人診所。

  • We are pleased that payors are recognizing the value of WINREVAIR and are already providing access to patients. Many payors have established coverage policies consistent with the label or STELLAR study criteria, while others are in the process of developing their policies. In summary, we are pleased with the strong start and look forward to continued progress in enabling access for appropriate patients over the coming months.

    我們很高興付款人認識到 WINREVAIR 的價值,並且已經為患者提供了使用機會。許多付款人已經制定了符合標籤或 STELLAR 研究標準的承保政策,而其他付款人正在製定其政策。總之,我們對良好的開端感到高興,並期待在未來幾個月為適當的患者提供服務方面繼續取得進展。

  • Our animal health business delivered another solid quarter, with sales increasing 6%. Livestock sales grew 11%, driven by higher demand for poultry and ruminant products, as well as price. Companion animal sales grew 1%, reflecting price partially offset by a reduction in distributor inventory. We are also excited to have launched a long-acting BRAVECTO injectable in a number of international markets during June.

    我們的動物保健業務在本季再次表現強勁,銷售額成長了 6%。由於對家禽和反芻動物產品的需求增加以及價格上漲,牲畜銷售額增加了 11%。伴侶動物銷售成長 1%,反映價格被經銷商庫存的減少部分抵銷。我們也很高興在 6 月在多個國際市場推出了長效 BRAVECTO 注射。

  • 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 80.9%, an increase of 4.3 percentage points, driven by reduced royalty rates for KEYTRUDA and GARDASIL, as well as favorable product mix.

    現在我將向您介紹我們損益表的其餘部分,我的評論將基於非公認會計原則。毛利率為 80.9%,成長 4.3 個百分點,主要得益於 KEYTRUDA 和 GARDASIL 特許權使用費降低以及有利的產品組合。

  • Operating expenses decreased to $6.2 billion. There were no significant business development expenses in the quarter, compared with a $10.2 billion charge a year ago. Excluding this charge, operating expenses grew 8%, reflecting strategic investments to realize the promise of our robust early and late-phase pipeline and support the promotion of our key growth drivers.

    營運費用減少至 62 億美元。與一年前的 102 億美元費用相比,本季沒有重大的業務開發費用。扣除此項費用,營運費用成長了 8%,反映出策略性投資,以實現我們強大的早期和後期產品線的承諾,並支持促進我們的關鍵成長動力。

  • Other expense was $108 million. Our tax rate was 14.1%. Taken together, earnings per share were $2.28.

    其他費用為 1.08 億美元。我們的稅率是14.1%。合計每股收益為 2.28 美元。

  • Now, turning to our 2024 non-GAAP guidance, the continued operational strength of our business has enabled us to raise and narrow our full-year revenue guidance. We now expect revenue to be between $63.4 billion and $64.4 billion, an increase of approximately $200 million at the midpoint. Our increased guidance range represents strong year-over-year revenue growth of 5% to 7%, including an approximate 3-percentage-point negative impact from foreign exchange using mid-July rates. Our gross margin assumption remains approximately 81%.

    現在,轉向我們的 2024 年非 GAAP 指導,我們業務的持續營運實力使我們能夠提高和縮小全年收入指引。我們現在預計收入將在 634 億美元至 644 億美元之間,中間增加約 2 億美元。我們提高的指導範圍意味著營收年增 5% 至 7%,其中包括使用 7 月中旬匯率計算的外匯帶來的約 3 個百分點的負面影響。我們的毛利率假設仍約為 81%。

  • We now expect operating expenses to be between $26.8 billion and $27.6 billion. This range reflects an incremental $1.5 billion of charges related to the one-time cost to acquire EyeBio and ongoing expenses to advance the assets, as well as investments to progress our innovative pipeline. As a reminder, our guidance does not assume additional significant potential business development transactions.

    我們目前預計營運支出將在 268 億美元至 276 億美元之間。這一範圍反映了與收購 EyeBio 的一次性成本和推進資產的持續費用以及推進我們的創新管道的投資相關的 15 億美元增量費用。提醒一下,我們的指導意見並未假設額外的重大潛在業務發展交易。

  • Other expense is expected to be approximately $350 million, which now includes financing costs for the acquisitions of EyeBio and Elanco's aqua business.

    其他費用預計約為 3.5 億美元,其中包括收購 EyeBio 和 Elanco 水產品業務的融資成本。

  • Our full-year tax rate is now expected to be between 15.5% and 16.5%, which includes an unfavorable impact related to the EyeBio acquisition that is not tax deductible. We assume approximately 2.54 billion shares outstanding.

    目前,我們的全年稅率預計在 15.5% 至 16.5% 之間,其中包括與 EyeBio 收購相關的不可免稅的不利影響。我們假設流通股約為 25.4 億股。

  • Taken together, we expect EPS of $7.94 to $8.04. This range includes a negative impact from foreign exchange of more than $0.30 using mid-July rates.

    綜合來看,我們預計每股收益為 7.94 美元至 8.04 美元。該範圍包括以 7 月中旬匯率計算超過 0.30 美元的外匯負面影響。

  • Recall, our prior guidance range was $8.53 to $8.65. Including the one-time charge of $1.3 billion, or $0.51 per share, related to the acquisition of EyeBio and an estimated $0.09 to advance the assets as well as finance the EyeBio and Elanco aqua business transactions, our prior guidance range would have been $7.93 to $8.05, with a midpoint of $7.99. Our current guidance midpoint remains the same, as our higher revenue estimate is being offset by increased investments to support our business.

    回想一下,我們之前的指導範圍是 8.53 美元至 8.65 美元。包括與收購EyeBio 相關的13 億美元一次性費用,即每股0.51 美元,以及用於推進資產以及為EyeBio 和Elanco aqua 業務交易提供資金的估計0.09 美元,我們之前的指導範圍為7.93 美元至7.93 美元。我們目前的指導中點保持不變,因為我們較高的收入預期被增加的投資支持我們的業務所抵消。

  • As you consider your models, there are a few items to keep in mind. We look forward to the opportunity to help protect certain adults from invasive pneumococcal disease and pneumococcal pneumonia following the recent FDA approval and ACIP recommendation of CAPVAXIVE. We are now working toward the achievement of certain milestones that will enable commercial uptake. These milestones include publication in the Morbidity and Mortality Weekly Report, which typically lags an ACIP recommendation by a few months, as well as obtaining payor coverage and contracting with customers.

    當您考慮模型時,需要記住一些事項。在 CAPVAXIVE 最近獲得 FDA 批准和 ACIP 推薦後,我們期待有機會幫助保護某些成年人免受侵襲性肺炎球菌疾病和肺炎球菌肺炎的侵害。我們現在正在努力實現某些里程碑,以實現商業應用。這些里程碑包括在發病率和死亡率每週報告中發布(該報告通常比 ACIP 的建議滯後幾個月),以及獲得付款人保險並與客戶簽訂合約。

  • For GARDASIL, over the past few years, we've benefitted from extremely strong demand in China, including from the expanded indication for GARDASIL 9 to the 9- to 45-year age cohort in late 2022. In the second quarter however, there was a significant step down in shipments from our distributor and commercialization partner, Zhifei, into the points of vaccination, compared with prior quarters, resulting in above normal inventory levels at Zhifei.

    對於 GARDASIL 來說,過去幾年,我們受益於中國極其強勁的需求,包括 2022 年底將 GARDASIL 9 的適應症擴大到 9 至 45 歲年齡組。 ,我們的經銷商和商業化合作夥伴智飛向疫苗接種點的出貨量大幅下降,導致智飛的庫存水準高於正常水準。

  • We are working closely with them to more fully understand the dynamics that caused this change. As we learn more, we will assess future shipments to our partner and work to bring their inventory back to more normal levels. If shipments from Zhifei into the points of vaccination do not increase, it is likely that we will ship less than our full-year 2024 contracted doses by the end of this year.

    我們正在與他們密切合作,以更全面地了解導致這一變化的動力。隨著我們了解更多,我們將評估未來向合作夥伴發貨的情況,並努力將他們的庫存恢復到更正常的水平。如果從智飛到疫苗接種點的出貨量不增加,到今年年底,我們的出貨量可能會低於 2024 年全年合約劑量。

  • We believe the opportunity in China remains very attractive as there are more than 120 million females in the addressable population living in Tier 1 to Tier 5 cities who have not yet received the protection of an HPV vaccine. As we said before, it will take increasing efforts to educate and activate the next wave of patients. Together with Zhifei, we are focused on and committed to investing in additional resources and patient education on the value of GARDASIL given the important benefits it provides.

    我們相信,中國的機會仍然非常有吸引力,因為居住在 1 至 5 線城市的目標人群中,有超過 1.2 億女性尚未獲得 HPV 疫苗的保護。正如我們之前所說,需要加強教育和激活下一波患者。鑑於 GARDASIL 提供的重要益處,我們與智飛一起專注於並致力於投資額外的資源和病患教育,以了解 GARDASIL 的價值。

  • We also look forward to the potential approval for males which, we believe, represents a meaningful opportunity. More broadly, we remain confident in the opportunity for GARDASIL globally based on the protection it provides against HPV-related cancers and low immunization levels overall and continue to believe we will achieve sales of over $11 billion by 2030.

    我們也期待男性的潛在批准,我們相信,這代表著一個有意義的機會。更廣泛地說,我們對GARDASIL 在全球範圍內的機會充滿信心,因為它提供了針對HPV 相關癌症的保護作用,且整體免疫水平較低,並繼續相信到2030 年我們的銷售額將超過110 億美元。

  • Our initial launch of WINREVAIR is having a positive impact for patients. We are very pleased with its performance and look forward to supporting more patients in the US and across the globe.

    我們首次推出 WINREVAIR 對患者產生了正面影響。我們對其表現非常滿意,並期待為美國和全球更多的患者提供支持。

  • Outside the US, we are pleased with the positive CHMP opinion and potential near-term launch in Europe. Following EU approval, we will need to obtain reimbursement, which should occur in 2025 in most major markets, but expect that Germany will receive reimbursement and launch this year. We remain confident in the successful launch of WINREVAIR, consistent with our high expectations, and look forward to providing further updates on our progress.

    在美國以外,我們對 CHMP 的正面意見以及近期可能在歐洲推出感到高興。在歐盟批准後,我們將需要獲得報銷,這應該在 2025 年在大多數主要市場發生,但預計德國將在今年獲得報銷並推出。我們對 WINREVAIR 的成功推出仍然充滿信心,這符合我們的高期望,並期待提供有關我們進展的進一步更新。

  • 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 expansive pipeline of novel candidates, each of which has significant potential to address important unmet medical needs.

    現在,轉向資本配置,我們的策略保持不變,我們將優先投資於我們的業務,以推動近期和長期成長。我們將繼續投資於我們廣泛的新候選藥物管道,每一個都具有解決重要的未滿足的醫療需求的巨大潛力。

  • We remain committed to our dividend and plan to increase it over time. Business development remains a priority, and we are well positioned to pursue additional science-driven, value-enhancing transactions. We will continue to execute a modest level of share repurchases.

    我們仍然致力於支付股息,並計劃隨著時間的推移增加股息。業務發展仍然是首要任務,我們有能力追求更多科學驅動、增值的交易。我們將繼續進行適度的股票回購。

  • To conclude, as we enter the second half of the year, there is continued strength in our business, driven by global demand and commercial execution. We remain confident in our outlook, driven by our unwavering commitment to leverage leading-edge science to save and improve the lives of patients. With investment in innovation and our ongoing focus on execution, we are well positioned to deliver value to patients, customers, and shareholders now and well into the future.

    總而言之,隨著進入下半年,在全球需求和商業執行的推動下,我們的業務持續強勁。我們對我們的前景仍然充滿信心,我們堅定不移地致力於利用尖端科學來拯救和改善患者的生活。透過對創新的投資和對執行的持續關注,我們有能力為現在和未來的患者、客戶和股東創造價值。

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

    有了這個,我現在想把電話轉給迪恩。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Thank you, Caroline.

    謝謝你,卡洛琳。

  • Momentum continued in the second quarter with several clinical and regulatory milestones, as well as progress in our science-led business development strategy. Today, I will speak first to programs in vaccines, then cover oncology, followed by cardiometabolic disease.

    第二季繼續保持勢頭,實現了多個臨床和監管里程碑,以及我們以科學為主導的業務發展策略的進展。今天,我將首先談論疫苗項目,然後討論腫瘤學,然後是心臟代謝疾病。

  • As Rob noted, last month, the FDA approved CAPVAXIVE, our 21-valent pneumococcal conjugate vaccine, and we subsequently received a unanimous recommendation from the CDC’s Advisory Committee of Immunization Practices for its use in certain adult populations. CAPVAXIVE is the first vaccine specifically designed to help protect adults against pneumococcal pneumonia and invasive pneumococcal disease and, as such, provides an important new public health option.

    正如 Rob 所指出的那樣,上個月,FDA 批准了我們的 21 價肺炎鏈球菌結合疫苗 CAPVAXIVE,隨後我們收到了 CDC 免疫實踐諮詢委員會的一致建議,建議將其用於某些成年人群。 CAPVAXIVE 是第一種專門設計用於幫助保護成年人免受肺炎球菌肺炎和侵襲性肺炎球菌疾病的疫苗,因此提供了一種重要的新公共衛生選擇。

  • It has been designed to address those serotypes responsible for approximately 85% of the incidence of invasive pneumococcal disease in individuals 65 years and older based on CDC-generated surveillance data. The CAPVAXIVE marketing authorization application is also under review by the European Medicines Agency's Committee for Medicinal Products for Human Use.

    根據 CDC 產生的監測數據,它旨在針對 65 歲及以上人群中約 85% 的侵襲性肺炎球菌疾病發生率負責的血清型。 CAPVAXIVE 行銷授權申請也正在接受歐洲藥品管理局人用藥品委員會的審查。

  • We continue to evaluate novel approaches to alleviate the burden of infectious disease. Recently, we announced positive topline results for clesrovimab, our investigational respiratory syncytial virus-preventative antibody, a single, fixed-dose option to help protect infants from birth through their first full RSV season. In the Phase 2b/3 trial, clesrovimab met its primary efficacy and safety endpoints, as well as its secondary endpoint regarding RSV-associated hospitalization. Detailed findings of the study will be presented at an upcoming scientific congress, and we plan to file these data with global regulatory authorities.

    我們繼續評估減輕傳染病負擔的新方法。最近,我們宣布了 clesrovimab 的積極頂線結果,這是我們正在研究的呼吸道合胞病毒預防抗體,它是一種單一固定劑量選擇,可幫助保護嬰兒從出生到第一個完整的 RSV 季節。在 2b/3 期試驗中,clesrovimab 達到了其主要療效和安全性終點,以及有關 RSV 相關住院治療的次要終點。研究的詳細結果將在即將召開的科學會議上公佈,我們計劃向全球監管機構提交這些數據。

  • Globally, RSV infection is a leading cause of hospitalization for otherwise healthy infants under one year of age. The historically high surge in incidence in the 2022-2023 season reinforced the need for more effective preventative measures.

    在全球範圍內,RSV 感染是一歲以下健康嬰兒住院的主要原因。 2022-2023 年季節發病率創歷史新高,凸顯了採取更有效預防措施的必要性。

  • Now, to oncology, during the investor event at ASCO, we detailed how we have leveraged our foundational position with KEYTRUDA to create a diverse pipeline by executing on our three-pillared strategy comprised of immuno-oncology, precision molecular targeting, and tissue-targeting candidates. This quarter, tangible progress has been made across each of these pillars.

    現在,對於腫瘤學,在ASCO 的投資者活動期間,我們詳細介紹了我們如何利用我們在KEYTRUDA 的基礎地位,透過執行我們的三大支柱策略(包括免疫腫瘤學、精準分子靶向和組織靶向)來創建多樣化的產品線候選人。本季度,每個支柱都取得了實際進展。

  • In immuno-oncology, we received FDA approval for the combination of KEYTRUDA and chemotherapy for the treatment of primary advanced or recurrent endometrial cancer, regardless of mismatch repair status, based on the Phase 3 KEYNOTE-868 study. Data continues to flow from KEYTRUDA clinical development program, including from studies which achieve an overall survival benefit, the gold standard for many oncology trials.

    在免疫腫瘤學方面,基於 3 期 KEYNOTE-868 研究,我們獲得了 FDA 批准 KEYTRUDA 與化療聯合治療原發性晚期或復發性子宮內膜癌,無論錯配修復狀態如何。 KEYTRUDA 臨床開發計畫持續提供數據,包括實現整體存活獲益的研究,這是許多腫瘤學試驗的黃金標準。

  • We announced an overall survival benefit in high-risk, early-stage triple negative breast cancer based on the KEYNOTE-522 study. KEYTRUDA is the only PD-1 or PD-L1 to date to receive approval for nine earlier-stage indications, of which four have now demonstrated a statistically significant overall survival benefit, including in non-small cell lung cancer, renal cell carcinoma, cervical cancer and, most recently, triple negative breast cancer.

    根據 KEYNOTE-522 研究,我們宣布了高風險早期三陰性乳癌的整體存活獲益。 KEYTRUDA 是迄今為止唯一獲得9 種早期適應症批准的PD-1 或​​ PD-L1,其中4 種現已證明具有統計學上顯著的總體生存獲益,包括非小細胞肺癌、腎細胞癌、子宮頸癌癌症,以及最近的三陰性乳癌。

  • We were pleased to announce that KEYNOTE-811 met its overall survival dual primary endpoint for the first-line treatment of patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. These results build on the previously reported positive data that formed the basis for the FDA approval last year. A similar approval was received from the National Medical Products Administration in China this quarter.

    我們很高興地宣布,KEYNOTE-811 達到了 HER2 陽性晚期胃或胃食道交界腺癌患者一線治療的總體生存雙重主要終點。這些結果建立在先前報告的積極數據的基礎上,這些數據構成了 FDA 去年批准的基礎。本季中國國家藥品監督管理局也獲得了類似的批准。

  • Also in immuno-oncology, the FDA granted priority review for KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma, based on the overall survival benefit demonstrated in the KEYNOTE-483 trial. The FDA has set a target action date of September 25. KEYTRUDA has now received approval for 40 distinct indications in the US and has demonstrated statistically significant overall survival in 25 trials.

    同樣在免疫腫瘤學領域,基於 KEYNOTE-483 試驗中證明的總體生存獲益,FDA 優先審查了 KEYTRUDA 與化療聯合用於不可切除的晚期或轉移性惡性胸膜間皮瘤患者的一線治療。 FDA 已將目標行動日期定為 9 月 25 日。

  • Next, to precision molecular targeting, we exercised the exclusive development option to advance the program for opevesostat, an oral non-steroidal inhibitor of CYP11A1, through our collaboration with Orion. Two pivotal Phase 3 trials evaluating opevesostat in combination with hormone replacement therapy for the treatment of certain patients with metastatic prostate cancer, OMAHA-1 and OMAHA-2, are ongoing.

    接下來,為了精確的分子靶向,我們透過與 Orion 的合作,行使了獨家開發選擇權來推進 opevesostat(一種 CYP11A1 口服非甾體抑製劑)項目。兩項評估 opevesostat 合併荷爾蒙替代療法治療某些轉移性前列腺癌患者 OMAHA-1 和 OMAHA-2 的關鍵 3 期試驗正在進行中。

  • Lastly, in the tissue-targeting space, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval for KEYTRUDA in combination with Padcev for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

    最後,在組織靶向領域,歐洲藥品管理局人用醫藥產品委員會採納了積極意見,建議批准 KEYTRUDA 與 Padcev 聯合用於不可切除或轉移性尿路上皮癌成年患者的一線治療。

  • We are also advancing a broad portfolio of diverse antibody-drug conjugates with Kelun-Biotech and Daiichi Sankyo, as well as our own internal programs. Last month, together with Daiichi Sankyo, we announced receipt of a Complete Response Letter from the FDA for the biologics license application for patritumab deruxtecan for the treatment of certain adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies.

    我們也與 Kelun-Biotech 和 Daiichi Sankyo 合作,以及我們自己的內部項目,推進廣泛的多樣化抗體藥物偶聯物產品組合。上個月,我們與第一三共公司一起宣布收到FDA 的關於patritumab deruxtecan 生物製劑許可申請的完整回复信,該藥物用於治療某些先前接受過治療的局部晚期或轉移性EGFR 突變非小細胞肺癌成年患者合併兩種或多種全身性療法。

  • The letter was issued based on findings from an inspection of a third-party manufacturing site. We are working with Daiichi Sankyo to provide appropriate support as they work with the FDA and the manufacturer to address the feedback in a timely manner. Of note, the findings identified in the CRL have no bearing on either ifinatamab deruxtecan nor raludotatug deruxtecan.

    這封信是根據對第三方生產場地的檢查結果發出的。我們正在與第一三共公司合作,提供適當的支持,因為他們與 FDA 和製造商合作,及時處理回饋。值得注意的是,CRL 中確定的結果對 ifinatamab deruxtecan 和 raludotatug deruxtecan 均沒有影響。

  • Turning to cardiometabolic disease, as Caroline indicated, there is strong interest from physicians and patients for WINREVAIR in the US. Building on this momentum, we were pleased to receive a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending the approval of WINREVAIR as a treatment option for certain patients with pulmonary arterial hypertension. The European Commission's decision on the marketing authorization application is expected in the third quarter.

    談到心臟代謝疾病,正如 Caroline 指出的那樣,美國的醫生和患者對 WINREVAIR 表現出濃厚的興趣。在此勢頭的基礎上,我們很高興收到歐洲藥品管理局人用藥品委員會的積極意見,建議批准 WINREVAIR 作為某些肺動脈高壓患者的治療選擇。歐盟委員會預計將在第三季對上市許可申請做出決定。

  • Finally, we continue to execute on our science-led business development strategy with a focus on seamlessly integrating efforts across our internal pipeline with the best external science through our One Pipeline approach. We recently closed the acquisition of EyeBio that includes Restoret, MK-3000, an investigational, late-phase, potentially first-in-class tetravalent, tri-specific Wnt antibody candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as additional preclinical assets targeting retinal diseases. There remains a significant medical need in this space and our teams are eager to work alongside the talented EyeBio team to advance these promising candidates.

    最後,我們繼續執行以科學為主導的業務發展策略,重點是透過我們的「單一管道」方法將我們內部管道的工作與最佳的外部科學無縫整合。我們最近完成了對EyeBio 的收購,其中包括Restoret、MK-3000,這是一種研究性、後期、可能首創的四價、三特異性Wnt 候選抗體,用於治療糖尿病性黃斑水腫和新生血管性老年性黃斑部病變。該領域仍然存在巨大的醫療需求,我們的團隊渴望與才華橫溢的 EyeBio 團隊合作,以推進這些有前途的候選人。

  • In closing, over the past three-plus years, we have successfully built on the solid foundation established by the previous leadership team to assemble one of the strongest pipelines in recent memory. We have diversified in oncology while strengthening and expanding in other therapeutic areas, including cardiometabolic, immunology, infectious diseases, neuroscience, and vaccines. We have strong momentum, and I look forward to providing further updates on our progress.

    最後,在過去三年多的時間裡,我們成功地建立了前領導團隊所奠定的堅實基礎,組成了近年來最強大的管道之一。我們在腫瘤學領域多元化,同時加強和擴展其他治療領域,包括心臟代謝、免疫學、傳染病、神經科學和疫苗。我們勢頭強勁,我期待提供有關我們進展的進一步更新。

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

    現在,我把電話轉回給彼得。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Thank you, Dean. Brad, we're ready for Q&A now. And I request that analysts limit themselves to one question today. Thank you.

    謝謝你,迪恩。布拉德,我們現在準備好進行問答了。我請求分析師今天只回答一個問題。謝謝。

  • Operator

    Operator

  • (Operator Instructions) Chris Schott, JPMorgan.

    (操作員指示)Chris Schott,摩根大通。

  • Chris Schott - Analyst

    Chris Schott - Analyst

  • Great. Thanks so much for the question, and congrats on the progress. I just want to kick off with just a question on GARDASIL dynamics in China. Maybe just a two-part question here. First, can you quantify what percent of your international sales are coming from China, and just any additional color on what drove the step down in 2Q? I'm trying to get my hands around this.

    偉大的。非常感謝您的提問,並祝賀您的進展。我想先問一個有關 GARDASIL 在中國動態的問題。也許這裡只是一個由兩個部分組成的問題。首先,您能否量化一下您的國際銷售額中有多少百分比來自中國,以及推動第二季銷售額下降的任何其他資訊?我正在努力解決這個問題。

  • And maybe as part of that, the 2024 guidance update, is the potential for shipments to come below the 2024 contracted dosage now reflected in that guidance? Or would that represent an incremental headwind to numbers to the extent that played out? Thank you.

    也許作為 2024 年指導更新的一部分,該指導中現在是否反映了出貨量低於 2024 年合約劑量的可能性?或者說,這是否代表數字的逆風增加到了所發生的程度?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Great. Thanks, Chris, and thanks for the question. And I'll maybe take the first part and then ask Caroline to comment on guidance.

    偉大的。謝謝克里斯,也謝謝你的提問。我可能會先聽第一部分,然後請卡洛琳對指導意見發表評論。

  • To your question, China represents, for GARDASIL, about 60% to 70% of the number, so that kind of gives you a sense of it. But maybe to give some context on what we saw in the quarter, and as we look to the full year and where we see things going, so let me start maybe by talking a little bit about the dynamics.

    對於你的問題,對於 GARDASIL 來說,中國約佔總數的 60% 到 70%,所以這讓你有一種感覺。但也許是為了介紹我們在本季度看到的情況以及我們展望全年以及我們看到的情況的一些背景,所以讓我先談談動態。

  • The opportunity that exists for GARDASIL in China remains very attractive, with more than 120 million eligible females in China yet to be protected against HPV, which represents about 60% to 70% of the eligible population. And I think we all recognize the benefits of protection against HPV-related disease is clear and importantly aligns with China's Healthy 2030 initiative. So the underlying support, we continue to believe, is there.

    GARDASIL 在中國的機會仍然非常有吸引力,中國有超過 1.2 億符合條件的女性尚未獲得 HPV 保護,約佔符合條件人口的 60% 至 70%。我認為我們都認識到預防 HPV 相關疾病的好處是顯而易見的,並且重要的是符合中國的「健康 2030」倡議。因此,我們仍然相信,潛在的支持是存在的。

  • In addition, we have filed for the male indication, which has been accepted and represents another significant opportunity. So as we think about China, I just want to set the context, because I think it's important to understand, we continue to have a very meaningful opportunity in the China market.

    此外,我們還申請了男性適應症,該適應症已被接受,這代表著另一個重大機會。因此,當我們考慮中國時,我只想設定背景,因為我認為了解這一點很重要,我們在中國市場仍然擁有非常有意義的機會。

  • What's unclear to us, and what we're trying to understand, is that during the second quarter, we saw a significant step down in shipments from Zhifei to the points of vaccination. The reductions during the second quarter was surprising, and I would point out, was a meaningful departure from prior trends we've seen both throughout really all of 2023 and into the first quarter of 2024.

    我們不清楚也是我們試圖了解的是,在第二季度,我們看到從智飛到疫苗接種點的出貨量大幅下降。第二季的減少令人驚訝,我想指出的是,這與我們在 2023 年全年和 2024 年第一季看到的先前趨勢有很大的不同。

  • So as we look at this, we're wanting to understand what would cause the trend break we saw. And I can tell you, what we know as of now is we believe there could be multiple factors that may be contributing to this dynamic, and we're working closely with our partner to try to tease out what exactly is happening.

    因此,當我們研究這個問題時,我們想要了解是什麼導致了我們所看到的趨勢突破。我可以告訴你,目前我們所知道的是,我們相信可能有多種因素導致了這種動態,我們正在與我們的合作夥伴密切合作,試圖弄清楚究竟發生了什麼。

  • But overall, the data we track indicates that the whole HPV market in China experienced this step down. So this is not a Merck-specific event. And importantly, we see the market share for GARDASIL as stable -- or actually increasing right now in the marketplace. We don't believe this step down, therefore, represents any change in the competitive dynamic, and GARDASIL remains by far the market leader.

    但總體而言,我們追蹤的數據表明,中國整個 HPV 市場經歷了這一下降。所以這不是默克特有的活動。重要的是,我們認為 GARDASIL 的市場份額穩定,或者目前在市場上實際上正在增​​加。因此,我們認為此次降級並不代表競爭動態發生任何變化,而 GARDASIL 迄今為止仍然是市場領導者。

  • We do believe, however, that based on the intelligence we've gathered, activity in the HPV vaccine area has been recently impacted by China's anti-bribery and anti-corruption drive, which, as you know, started really last year. And up to that point, we really haven't seen much impact, but we do believe we are starting to see it now. And this is really driven by the fact that, in the healthcare industry, there has been as a result of this, a reduction in scientific engagement, primarily in the CDC within China and fewer immunizations. So we need to tease that out more.

    然而,我們確實相信,根據我們收集到的情報,HPV 疫苗領域的活動最近受到了中國反賄賂和反腐敗運動的影響,正如你所知,中國的反賄賂和反腐敗運動實際上是從去年開始的。到目前為止,我們確實還沒有看到太大的影響,但我們確實相信我們現在已經開始看到它了。這實際上是由這樣一個事實驅動的:在醫療保健行業,科學參與減少,主要是在中國疾病預防控制中心,免疫接種也減少了。所以我們需要進一步整理這一點。

  • And in addition, we did see reduced levels of promotional support for HPV vaccination at the same time that our distribution partner, Zhifei, broadened its portfolio, so we'll need to get more into that. But obviously, we have a very strong relationship with Zhifei, and we already have started to put in place a robust plan to invest in increased promotional efforts really designed to drive awareness, education, and activation of the remaining female opportunity. And this includes both resources at Zhifei and more selling resources and promotional resources, as well as promotional resources being deployed directly from Merck.

    此外,我們確實看到,在我們的分銷合作夥伴智飛擴大其產品組合的同時,對 HPV 疫苗接種的促銷支持水平有所下降,因此我們需要在這方面投入更多。但顯然,我們與智飛有著非常牢固的關係,我們已經開始製定一項強有力的計劃,加大投資力度,真正旨在提高意識、教育和激活剩餘的女性機會。這既包括智飛的資源,也包括更多的銷售資源和促銷資源,以及默克直接部署的促銷資源。

  • So as we look forward, we will have to see how all of these activities impact shipments to the point of vaccination. And as we learn more, we'll assess future shipments to China with our partner. So hopefully, that gives you a sense of what we're seeing.

    因此,展望未來,我們必須了解所有這些活動如何影響疫苗接種的運輸。隨著我們了解更多,我們將與合作夥伴一起評估未來對中國的出貨。希望這能讓您了解我們所看到的情況。

  • But I just would reiterate one other point, and that's that as we look to the long term, given both the opportunity in China I mentioned for the 120 million remaining females, as well as the potential for the male indication, outside of China, we saw double-digit growth across all regions in the quarter. So we continue to be on track, doing well, and driving growth in this important vaccine. And that's why you heard Caroline, in our prepared comments, reiterate our confidence in the $11 billion number by 2030, even taking into account what we saw happening in China this quarter.

    但我只想重申另一點,那就是,從長遠來看,考慮到我提到的中國為剩餘 1.2 億女性提供的機會,以及中國以外男性適應症的潛力,我們本季度所有地區均實現兩位數增長。因此,我們繼續走上正軌,表現良好,並推動這項重要疫苗的成長。這就是為什麼你聽到 Caroline 在我們準備好的評論中重申我們對 2030 年達到 110 億美元這一數字的信心,甚至考慮到我們本季在中國看到的情況。

  • So with that, maybe I'll turn it over to Caroline, and she can address your guidance-specific question. Caroline?

    因此,也許我會將其轉交給卡羅琳,她可以解決您的具體指導問題。卡洛琳?

  • Caroline Litchfield - Chief Financial Officer, Executive Vice President

    Caroline Litchfield - Chief Financial Officer, Executive Vice President

  • Thank you, Rob. So Chris, in terms of our guidance, we've assumed a range of scenarios, from providing the fully contracted 2024 doses during this year to providing something less than that. If I anchor to the midpoint of our guidance, we have been measured in assuming a scenario that has less than the contracted 2024 GARDASIL doses shipped to China.

    謝謝你,羅布。因此,克里斯,根據我們的指導,我們假設了一系列情景,從今年提供完全合約規定的 2024 年劑量到提供少於該劑量的劑量。如果我錨定我們指導的中點,我們是在假設的情況下進行衡量的,該情況的數量少於合約規定的 2024 年運往中國的 GARDASIL 劑量。

  • And even with that, we were able to raise our guidance at the midpoint by $200 million. And that's really as a result of the underlying momentum that we have in the rest of our business, including oncology with KEYTRUDA and WELIREG. It includes in animal health, with the launch of BRAVECTO in injectable, as well as the acquisition of the Elanco aqua business. And we remain confident in our outlook for WINREVAIR and the opportunities to drive patient impact and growth, consistent with our high expectations.

    即便如此,我們還是能夠將中點指引提高 2 億美元。這實際上是我們其他業務的潛在動力的結果,包括 KEYTRUDA 和 WELIREG 的腫瘤學業務。其中包括動物健康領域,推出注射劑 BRAVECTO,以及收購 Elanco aqua 業務。我們對 WINREVAIR 的前景以及推動患者影響和成長的機會仍然充滿信心,這符合我們的高期望。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Chris. Next question, please, Brad.

    偉大的。謝謝你,克里斯。請下一個問題,布拉德。

  • Operator

    Operator

  • Umer Raffat, Evercore.

    烏默·拉法特,Evercore。

  • Umer Raffat - Analyst

    Umer Raffat - Analyst

  • Hi, guys. Thanks for taking my question. Can I just dial down the GARDASIL point just a little more? Rob, I know you mentioned there's an anti-bribery, anti-corruption drive going on in China which started last year. But it also feels like some of the shipment delays are happening perhaps a few months ahead of potential competition hitting the market as well. So could you speak to whether there's any future contracting happening and whether your long-term price integrity will stay intact on GARDASIL in China? Thank you.

    嗨,大家好。感謝您提出我的問題。我可以將 GARDASIL 分數再調低一點嗎?羅布,我知道你提到中國去年開始進行反賄賂、反貪腐運動。但也感覺有些出貨延遲可能是在潛在競爭進入市場前幾個月發生的。那麼您能否談談未來是否會發生任何合約以及您在中國的 GARDASIL 上的長期價格完整性是否會保持不變?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. No, thanks for the question. So everything we're seeing in the marketplace, I would just reiterate, would point to dynamics that we don't see in the competition -- the future potential competition. I think you're referring to the fact that we very well could see a 9-valent sometime next year come into the marketplace. So I don't believe, from anything we've heard in the marketplace, from competitive intelligence, as well as what we're hearing from Zhifei, that that is what's happening here.

    是的。不,謝謝你的提問。因此,我想重申一下,我們在市場上看到的一切都將指向我們在競爭中看不到的動態——未來的潛在競爭。我認為您指的是這樣一個事實:我們很可能會在明年某個時候看到 9 價商品進入市場。因此,從我們在市場上聽到的任何資訊、競爭情報以及我們從智飛那裡聽到的資訊來看,我不相信這裡正在發生這種情況。

  • As we look forward, and Caroline can comment specifically, we have always expected that as we see the peak move through from the indication we got for the expansion of the age cohort, that you would see a flattening out over time of the demand in China. And then that, for women specifically, and then we would bring on the male indications, that should allow us then to continue to drive the business forward from there.

    在我們展望未來時,卡羅琳可以具體評論,我們一直預計,當我們從年齡組擴張的跡像中看到高峰期過去時,您會看到中國的需求隨著時間的推移而趨於平緩。然後,特別是針對女性,然後我們將引入男性適應症,這將使我們能夠繼續推動業務向前發展。

  • Nothing has changed in that dynamic and what we're seeing right now. So as we look forward, our belief in China being a significant contributor is unchanged. But I'll let -- maybe Caroline can speak specifically as we're thinking about some of the guidance around how we think about next year.

    這種動態和我們現在所看到的一切都沒有改變。因此,展望未來,我們對中國作為重要貢獻者的信念並沒有改變。但我會讓——也許卡羅琳可以具體發言,因為我們正在考慮一些關於我們如何看待明年的指導。

  • Caroline Litchfield - Chief Financial Officer, Executive Vice President

    Caroline Litchfield - Chief Financial Officer, Executive Vice President

  • So what I would add is we have always contemplated that we would have a 9-valent competitor within the Chinese market. As such, the current contracted doses with Zhifei for 2025 are less than what the contract is for 2024, as we would expect to participate in that market, but understand a competitor would likely gain share in that market.

    所以我要補充的是,我們一直在考慮在中國市場上會有一個九價競爭對手。因此,目前與智飛簽訂的 2025 年合約劑量低於 2024 年合約劑量,因為我們預計會參與該市場,但了解競爭對手可能會在該市場獲得份額。

  • We also, though, as was said in the prepared remarks, have the potential opportunity of a male launch in China. And we are hopeful for an approval with GARDASIL 4 and 9 by the first half of next year and be coming to the market at that stage. So we are confident that China will remain an important part of our GARDASIL business as we move forward and, more importantly, are confident in the opportunity to drive GARDASIL longer term to the $11 billion that we've stated.

    不過,正如在準備好的發言中所說,我們也有可能在中國推出男性產品。我們希望 GARDASIL 4 和 9 能夠在明年上半年獲得批准並在該階段上市。因此,我們有信心,隨著我們的前進,中國仍將是我們 GARDASIL 業務的重要組成部分,更重要的是,我們有信心有機會將 GARDASIL 長期推向我們​​所說的 110 億美元。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. And maybe, Umer, just to give one little bit of color, because it's probably worth pointing out, I'm assuming people understand when we talk about the anti-bribery and anti-corruption, what is happening. And one question that could be there is this has been going on since late last year, and we did not see impacts early on. What's changed, and how do we see it evolving?

    是的。也許,烏默,只是為了提供一點顏色,因為可能值得指出,我假設人們理解當我們談論反賄賂和反腐敗時,正在發生的事情。可能存在的一個問題是,這種情況自去年年底以來一直在發生,而且我們很早就沒有看到影響。發生了什麼變化,我們如何看待它的演變?

  • What I would point out, first of all, one, just to reiterate, as we think about what's happening in China around the anti-bribery and anti-corruption, we very much support those activities because it means we have a fair, open, and transparent market. So we're very supportive of what the Chinese government is trying to do there.

    我要指出的是,首先,我想重申一下,當我們思考中國在反賄賂和反腐敗方面正在發生的事情時,我們非常支持這些活動,因為這意味著我們有一個公平、公開、和透明的市場。因此,我們非常支持中國政府在那裡所做的努力。

  • But as we see how this is impacting us, at the CDC, we have seen some dampening in them engaging in scientific discussions and driving for vaccination. We believe some of this could be due to the fact that there was criminal charges brought against a senior scientific representative, one of the local players, related to a COVID vaccine that we believe has had a dampening effect overall. And how long this lasts, how it will continue to play out, we'll have to see. But I thought I'd provide additional color because I don't want to assume that you all are aware of what really is happening there.

    但當我們看到這對我們有何影響時,在疾病預防控制中心,我們看到他們參與科學討論和推動疫苗接種的熱情有所減弱。我們認為,部分原因可能是由於一名高級科學代表(當地參與者之一)受到刑事指控,該指控與我們認為總體上具有抑製作用的新冠疫苗有關。這種情況會持續多久,將如何繼續發揮作用,我們拭目以待。但我想我應該提供額外的顏色,因為我不想假設你們都知道那裡到底發生了什麼事。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thanks, Umer. Next question, please, Brad.

    偉大的。謝謝,烏默。請下一個問題,布拉德。

  • Operator

    Operator

  • Carter Gould, Barclays.

    卡特·古爾德,巴克萊銀行。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • Good morning. Thanks for taking the questions. Maybe just switch gears and talk about WINREVAIR a bit, can you maybe characterize, or maybe go into -- in terms of the pace of new starts, do you see that sort of as sustainable or surpassable? And as we think about sort of that one-month delayed timeline from prescription to start, can you maybe characterize how much of that is sort of payer versus sort of the nurse training driven and if there's a chance that might evolve? Thank you.

    早安.感謝您提出問題。也許只是換個話題,談談 WINREVAIR,您能否描述一下,或者探討一下——就新啟動的步伐而言,您認為這種情況是可持續的還是可超越的?當我們考慮從處方到開始延遲一個月的時間表時,您能否描述其中有多少是付款人驅動的,而不是護士培訓驅動的,以及是否有可能發展的機會?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. No, thanks for the question. So to give you a sense of what we've seen as of the end of June, we've had more than 2,000 patients receive a prescription for WINREVAIR. So that's -- obviously, we feel very good about that. And right now, what our experience would tell us is that about 75% to 80% of those receiving a prescription will convert to commercial product. So that gives you a sense of what's happening.

    是的。不,謝謝你的提問。因此,為了讓您了解截至 6 月底我們所看到的情況,我們已經有 2,000 多名患者收到了 WINREVAIR 處方。顯然,我們對此感覺非常好。目前,我們的經驗告訴我們,大約 75% 到 80% 的處方藥患者會轉而使用商業產品。這樣您就可以了解正在發生的事情。

  • Right now, actually, in the quarter, driving the revenue you saw was about 1,000 patients actually on treatment -- had started treatment. So as we sit here today, you have 1,000 patients who have started treatment in the quarter, the 2,000 total scripts, and we would expect that the 75% to 80% of those 2,000 scripts will ultimately convert to be commercial sales.

    實際上,在本季度,目前推動收入成長的是大約 1,000 名實際接受治療的患者 - 已經開始治療。因此,當我們今天坐在這裡時,本季有 1,000 名患者開始接受治療,總共 2,000 個腳本,我們預計這 2,000 個腳本中的 75% 到 80% 最終將轉化為商業銷售。

  • And so if you look at what's driving that difference, some of that is due to access, but also some of it is due to patient dropout, and the fact that you will have some patients who, despite getting a script, after they go through blood work and go through the medical evaluations, don't qualify. So you have all of those dynamics happening.

    因此,如果你看看是什麼導致了這種差異,其中一些是由於訪問,但也有一些是由於患者退出,事實上,您將有一些患者,儘管獲得了腳本,但在他們完成之後抽血並進行醫療評估,不合格。所以所有這些動態都會發生。

  • If you look at the 30 days specifically that you're referring to, we think that probably the total period from when a person gets a script to when they get their approval from an access perspective is about two weeks to three weeks. So there is obviously opportunity to improve that. But just remember that in addition to going and getting a blood test, getting your insurance approval, you then have to schedule to have a nurse come to your home to go through the initiation and training around self-administration of WINREVAIR. So all of those elements are contributing to that timeframe. How much that tightens over time, we'll have to see.

    如果您具體查看您所指的 30 天,我們認為從一個人獲得腳本到從訪問角度獲得批准的總時間可能約為兩週到三週。所以顯然有機會改進這一點。但請記住,除了進行血液檢查、獲得保險批准之外,您還必須安排護理師到您家中進行有關 WINREVAIR 自我管理的啟動和培訓。因此,所有這些因素都對這個時間框架做出了貢獻。隨著時間的推移,這種情況會收緊多少,我們拭目以待。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Carter. Next question, please, Brad.

    偉大的。謝謝你,卡特。請下一個問題,布拉德。

  • Operator

    Operator

  • Tim Anderson, Wolfe Research.

    蒂姆·安德森,沃爾夫研究中心。

  • Tim Anderson - Analyst

    Tim Anderson - Analyst

  • Thank you very much. Just going back to GARDASIL, I know you're reiterating your $11 billion figure, at least $11 billion in 2030. The shape of the curve over that time in China specifically, which is only a part of that number, are there likely to be periods where year-on-year sales actually contract beyond 2024 in the inventory issue?

    非常感謝。回到 GARDASIL,我知道您重申了 110 億美元的數字,到 2030 年至少為 110 億美元。 ,哪些時期的年比銷售額實際上會收縮?

  • Because it does seem like pricing is really going to be at risk here. The way pricing works with vaccines in China and some of these other offsetting indications like males are going to take time to launch. So it seems like there may be periods there where you could have year-on-year declines in sales over the next, let's say, five or six years. So if you could just describe the shape of that curve, please.

    因為看起來定價確實會面臨風險。中國疫苗的定價方式以及其他一些抵銷指標(例如男性)需要時間才能推出。因此,在接下來的一段時間內,比如說五、六年,銷售額可能會比去年同期下降。所以請您描述一下該曲線的形狀。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah, sure. So as we look at it, we do expect you will see a flattening of the curve as we see the female indication be more fully penetrated. Obviously, more to go there, given what we believe is still the addressable population. And then it will ramp back to growth as the male population comes on in full. So that is what we're expecting to happen.

    好,當然。因此,當我們看到它時,我們確實希望您會看到曲線變平,因為我們看到女性適應症被更充分地滲透。顯然,考慮到我們認為仍然是可尋址人群,還有更多的工作要做。然後,隨著男性人口的全面增長,這一數字將恢復增長。這就是我們期望發生的事情。

  • And on the pricing point, I think it's just important to understand the way this market works and how we operate in the market. We sell into Zhifei. Zhifei then is responsible for doing the bidding with the provinces and actually then determining ultimately that end sale to the point of vaccination. As we look forward, I think it's important to understand that GARDASIL, as we think about the addressable population, we continue to believe will be a highly sought after vaccine, even in the face of competition.

    在定價方面,我認為了解這個市場的運作方式以及我們如何在市場中運作非常重要。我們賣成智飛。然後,智飛負責與各省進行招標,並最終確定疫苗接種的最終銷售。當我們展望未來時,我認為了解 GARDASIL 很重要,當我們考慮目標族群時,我們仍然相信,即使面對競爭,GARDASIL 也將是一種備受追捧的疫苗。

  • And we're dealing in an overall population when we quote the 200 million total females, of which we would say we're 30% to 40% penetrated today. That's really in the Tier 1 to 5 cities that we think can afford a cash pay market. The total population accessible in China is much bigger. And so I don't think we should assume we're all competing for that small slice. There's a much bigger slice. We've chosen not to go for that bigger piece because obviously we can't get into the local vaccination program because we don't produce GARDASIL in China. Our competitors will be able to do that.

    當我們引用 2 億女性總數時,我們所處理的是總體人口,我們可以說我們今天的滲透率為 30% 到 40%。這實際上是在我們認為可以承受現金支付市場的一到五線城市。中國的總人口多得多。所以我認為我們不應該假設我們都在爭奪這一小塊份額。還有更大的一塊。我們選擇不做更大的事情,因為顯然我們無法參與當地的疫苗接種計劃,因為我們在中國不生產 GARDASIL。我們的競爭對手將能夠做到這一點。

  • So I think I would just caution all to not view it as a zero-sum game. I think there's still market expansion opportunity in China that will benefit both us and the competitors.

    所以我想我只是提醒大家不要將其視為零和遊戲。我認為中國仍然存在市場擴張機會,這將使我們和競爭對手都受益。

  • And frankly, the other thing we have to see is how quickly will the male indication be given to others beyond us. We believe there's a chance we could be sitting alone with that as well. So the dynamics need to play themselves out. But I think we need to first understand is what we're seeing, in the quarter specific, a short-term event or something else. And that's still not clear because I would just point that the trend break was pretty significant. It's not what we've seen in any other market that you would expect. And that's why we're a little hesitant to say this is just demand in China.

    坦白說,我們必須看到的另一件事是,男性的跡象將以多快的速度傳遞給我們以外的其他人。我們相信我們也有可能獨自面對這個問題。因此,動態需要發揮作用。但我認為我們首先需要了解我們在特定季度中看到的情況、短期事件或其他情況。這仍然不清楚,因為我只想指出趨勢突破非常顯著。這不是您所期望的我們在任何其他市場中看到的情況。這就是為什麼我們有點猶豫地說這只是中國的需求。

  • And also, I would also bring back the fact that actually, if you separated out what happened in China, we had one of our strongest quarters in every other market around the world with strong double-digit growth. So those are all dynamics that will have to play themselves out.

    而且,我還要回顧一個事實,實際上,如果你把中國發生的事情分開,我們在全球所有其他市場中都經歷了最強勁的季度之一,並實現了強勁的兩位數增長。因此,這些都是必須自行發揮作用的動力。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Tim. Next question, please, Brad.

    偉大的。謝謝你,提姆。請下一個問題,布拉德。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD·考恩。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Thank you. How does clesrovimab compare on hospitalizations to Beyfortus, which has 85% to 90% effectiveness on hospitalizations? I appreciate you're not going to give out data specifics. But for instance, would you say your product is highly competitive? And I'm just curious, how does it achieve longer durability given that it has a shorter half-life than Beyfortus? Thank you.

    謝謝。 clesrovimab 在住院治療方面與 Beyfortus 相比如何,後者的住院有效率為 85% 至 90%?我很高興你不打算透露數據細節。但舉例來說,你會說你的產品具有很強的競爭力嗎?我只是很好奇,鑑於它的半衰期比 Beyfortus 短,它如何實現更長的耐用性?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yeah. So this is Dean. Thanks for the question. As you point out, there is a significant global unmet need, both for the healthy and at-risk infant. And as we've said, from the PK/PD studies as such, this is something that can be given as a single dose. It's not weight-based, so single dose broadly. And we are very comfortable in relationship to the PK/PD, in relationship to the half-life, in relationship to the affinity that the prevention which was studied would cover the entire RSV season, which is five to six months.

    是的。這就是迪恩。謝謝你的提問。正如您所指出的,全球健康嬰兒和高風險嬰兒的需求均未滿足。正如我們所說,從 PK/PD 研究來看,這是可以單劑量給藥的。它不是基於體重的,因此廣泛為單劑量。我們對 PK/PD、半衰期、親和力感到非常滿意,所研究的預防措施將涵蓋整個 RSV 季節,即五到六個月。

  • We did announce the top line. We're not going to get ahead of the public presentation of these that we hope to have at some session in the second half. I do point out that what you highlight is really important, which is the RSV-associated hospitalization will be a really important point in relationship to looking at this vaccine versus others. And we are very confident in that profile.

    我們確實宣布了頂線。我們不會提前公開這些內容,我們希望在下半年的某個會議上公開這些內容。我確實指出,您強調的內容非常重要,即與 RSV 相關的住院將是比較這種疫苗與其他疫苗的一個非常重要的點。我們對此非常有信心。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Steve. Next question, please, Brad.

    偉大的。謝謝你,史蒂夫。請下一個問題,布拉德。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    莫希特·班薩爾,富國銀行。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Great. Thank you very much for taking my question. And just to try to understand the long-term growth path for GARDASIL, it seems like, and correct me if I'm wrong, a lot of it would depend on raising awareness in those Tier 1 to 5 cities and male vaccinations. So the question is, of those Tier 1 to 5 cities, where do you think there is bigger opportunity, because going to Tier 4 and 5 could be challenging? And then based on your male vaccination experience in the developed world, how should we think about China in that context? Thank you.

    偉大的。非常感謝您回答我的問題。為了嘗試了解 GARDASIL 的長期成長路徑,如果我錯了,請糾正我,這很大程度上取決於提高 1 至 5 線城市的意識和男性疫苗接種。那麼問題是,在這些 1 到 5 線城市中,您認為哪裡有更大的機會,因為去 4 和 5 線可能會具有挑戰性?然後根據您在已開發國家的男性疫苗接種經驗,我們該如何看待中國?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. So if you look across the Tier 1 to 5 cities, we're actually -- when we quote that we're 30% to 40% penetrated, and again, this is just to the females, so this is -- we're only speaking to females right now. We're 30% to 40% penetrated. We're a little bit less penetrated. I think we're around kind of say 30%-ish in the 4 and 5 Tier cities, and we're around 40% in the 1 to 3. So there's not a huge spread between the Tier 1 to 3 and the 4 to 5. So we will continue to focus efforts across all of those areas as we have been to date.

    是的。所以,如果你看看 1 到 5 線城市,我們實際上——當我們引用我們的滲透率是 30% 到 40% 時,再說一次,這只是針對女性,所以這是——我們現在只和女性說話。我們的滲透率為 30% 到 40%。我們的滲透力稍差一些。我認為我們在 4 和 5 線城市的比例約為 30%,而在 1 至 3 線城市的比例約為 40%。 5. 因此,我們將一如既往,繼續在所有這些領域集中努力。

  • And then it's a whole different exercise to activate the male population across that same area, which frankly isn't there today because of the fact that we don't yet have the indication. As you think about how all of this fits into the broader global picture, I think it's also important just to remind everyone that the total penetration of GARDASIL on a global basis to the eligible population is approximately 10%. So our opportunity to activate patients globally as we bring on additional capacity is significant.

    然後,激活同一地區的男性人口是一項完全不同的活動,坦白說,今天還沒有這種活動,因為我們還沒有跡象。當您思考所有這些如何適應更廣泛的全球情況時,我認為提醒大家也很重要,GARDASIL 在全球範圍內對符合條件的人群的總滲透率約為 10%。因此,隨著我們增加能力,我們在全球範圍內激活患者的機會是巨大的。

  • And as we've talked about in the past, we are going to continue to look to activate the mid-adult segment in the private market. We're doing that today in Europe, and that's part of when I comment that we're driving double-digit growth across the rest of the world outside of China. Part of it is we are starting to see uptake in that private market activation, both in Europe and across parts of Latin America and Asia Pacific more broadly. We're going to continue to drive into the low and middle income markets. We see that as a meaningful opportunity going forward, and we are well on our way to getting our costs in a position to be able to compete in that space quite effectively. We will continue to drive that.

    正如我們過去談到的,我們將繼續尋求激活私人市場的中成人市場。我們今天在歐洲正在這樣做,這也是我評論說我們正在推動中國以外的世界其他地區實現兩位數增長的一部分。部分原因是我們開始看到私人市場的激活,無論是在歐洲還是拉丁美洲和亞太地區的部分地區。我們將繼續進軍中低收入市場。我們認為這是一個有意義的未來機會,我們正在努力降低成本,以便能夠在該領域非常有效地競爭。我們將繼續推動這項進程。

  • And then obviously, while China is the best example of where we need to get a male indication to drive for gender-neutral vaccination if we truly want to eliminate cervical cancer and increasingly address the other cancers we know related to people with HPV, including head and neck cancers, which are very prominent, especially if you look across the Asia Pacific area, that is work we will continue to do, but not only in China and across Asia, but also across Europe and other parts of the world where there still is a lot of opportunity to drive for gender-neutral. And then lastly, Japan is a market where we are continuing to see growth driven by the fact that we've had a renewed NIP program there, with both an initial NIP and a catch-up phase and, longer term, an opportunity for males there as well.

    顯然,如果我們真的想消除子宮頸癌並越來越多地解決我們所知道的與HPV 感染者相關的其他癌症,包括頭頸癌,那麼我們需要獲得男性適應症來推動性別中立的疫苗接種,而中國是最好的例子。地區,仍然存在著有許多機會推動性別中立。最後,我們在日本市場繼續看到成長,因為我們在那裡實施了更新的 NIP 計劃,包括初始 NIP 和追趕階段,從長遠來看,這為男性提供了機會那裡也有。

  • So the opportunities are significant. The context of how we will drive growth has multiple levers for us to look at to do that. And that's why we are confident in the $11 billion number long term. And I think that's important as we shape the overall context of the discussion.

    所以機會是巨大的。我們如何推動成長的背景有多種槓桿可供我們考慮來實現這一目標。這就是為什麼我們對 110 億美元的長期數字充滿信心。我認為這很重要,因為我們塑造了討論的整體背景。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thanks, Mohit. We have availability to go a bit past 10:00, so we'll continue on with questions. Next question, please, Brad.

    偉大的。謝謝,莫希特。 10:00 以後我們還有空,所以我們將繼續提問。請下一個問題,布拉德。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    路易莎·赫克托,貝倫貝格。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Good morning. Thanks for taking my question. I wanted to follow up on RSV antibody, please. Can you confirm that you can file in all major markets this year? And then I just wondered about China in this context. Is that a market where you'll be filing soon? And what the opportunity is there? How much education is required to access the private market? Thank you.

    早安.感謝您提出我的問題。我想跟進 RSV 抗體的情況。您能否確認今年可以在所有主要市場提交申請?然後我就想知道在這種背景下的中國。這是您即將提交申請的市場嗎?還有什麼機會呢?進入私人市場需要多少教育程度?謝謝。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yeah. So let me just level set in relationship to clesrovimab and the RSV antibody. So we have the data, and that data will be presented sometime in the second half of this year as the different plenary sessions of different conferences occur.

    是的。因此,讓我簡單介紹一下 clesrovimab 和 RSV 抗體的關係。所以我們有數據,這些數據將在今年下半年的某個時候隨著不同會議的不同全體會議的召開而公佈。

  • In relationship to filing, our plan is to file such that it would be available not for this season, but for the next season within the United States. And so that's the sort of next wave in relationship. So I want to make sure that there's no concept that this is coming out this RSV season. We're targeting next RSV season in relationship to when we're seeking approval and licensure.

    關於歸檔,我們的計劃是歸檔,以便它不會在本季可用,而是在美國境內的下一季可用。這就是關係中的下一波浪潮。所以我想確保沒有人知道這會在這個 RSV 賽季推出。我們的目標是下一個 RSV 季節,與我們尋求批准和許可的時間有關。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. And maybe just on the broader question, could this be an opportunity in China, we are continuing to look at all global markets. And I would point out, as Dean points out, we're looking at the '25, 26 RSV season, so next year. And then beyond that, we will go globally thereafter, and China is the market we are looking at.

    是的。也許只是在更廣泛的問題上,這在中國是否是一個機會,我們正在繼續關注所有全球市場。我想指出,正如 Dean 指出的那樣,我們正在關注 25、26 RSV 賽季,所以明年。除此之外,我們之後還會走向全球,中國就是我們關注的市場。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Luisa. Next question, please, Brad.

    偉大的。謝謝你,路易莎。請下一個問題,布拉德。

  • Operator

    Operator

  • Daina Graybosch, Leerink.

    戴娜·格雷博斯,萊林克。

  • Daina Graybosch - Analyst

    Daina Graybosch - Analyst

  • Hi. Thank you for the question. I want to ask about the recent ODAC that was on periadjuvant development in lung cancer. I wonder -- let's assume FDA takes a hard line on requiring the contribution of the neoadjuvant and adjuvant phases and you look forward to the current KEYTRUDA development program, do you see any risk to that hard line to any of your label extension plans? And how are you going back to looking at your development, especially of novel combos in the early stage, given that discussion? Thank you.

    你好。感謝你的提問。我想詢問最近關於肺癌輔助治療期間發展的 ODAC。我想知道 - 讓我們假設 FDA 對新輔助和輔助階段的貢獻採取強硬立場,並且您期待當前的 KEYTRUDA 開發計劃,您認為這種強硬路線對您的任何標籤擴展計劃有任何風險嗎?鑑於討論,您將如何回顧自己的發展,尤其是早期階段的新穎組合?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Thank you very much. So just to provide some context, the recent AdCom talked about how much of a PD-1 or a PD-L1 is put in earlier stage, especially in the resectable. And there's giving it before the surgery, there's giving it after the surgery, and it's giving it before and after the surgery. And the issue that comes up is, in this curative setting, what's the sort of relative benefit risk because it's different than in the metastatic.

    非常感謝。因此,為了提供一些背景信息,最近的 AdCom 討論了有多少 PD-1 或​​ PD-L1 被置於早期階段,特別是在可切除階段。有手術前給予,手術後給予,手術前及手術後給予。出現的問題是,在這種治療環境中,相對獲益風險是什麼,因為它與轉移中不同。

  • What I would just emphasize is we track and we are in discussions with the FDA in relationship to our clinical trials and as such. But I do want to emphasize the ability to show OS, especially in the earlier-stage cancers, is very difficult. And that's why we always emphasize we have nine earlier stage approvals, but we highlight that four of them have overall survival. And we, at this point, do not know anyone else who has four overall survivals.

    我想強調的是,我們正在追蹤並與 FDA 就我們的臨床試驗等進行討論。但我確實想強調顯示 OS 的能力,特別是在早期癌症中,是非常困難的。這就是為什麼我們總是強調我們有九個早期階段的批准,但我們強調其中四個具有總體生存期。目前,我們還不知道還有誰有四次總生存期。

  • I do want to point out that in two of those overall survivals, in TNBC and in lung, it is perioperative. So I think the future studies need to consider what the FDA has said. But the FDA has also been very clear that overall survival is the gold standard, especially in earlier stage. And as we build our program, we consider both the recent AdCom, but also the recent -- the continuing interest of the FDA to show contribution of components of a new agent on top of a PD-1 and showing overall survival and using platforms that have overall survival to show that when you add something even more, you continue to have increasing benefit in terms of overall survival.

    我確實想指出,其中兩項總存活率(TNBC 和肺部)是圍手術期的。所以我認為未來的研究需要考慮 FDA 的說法。但 FDA 也非常明確,整體存活率是黃金標準,尤其是在早期階段。當我們建立我們的計劃時,我們既考慮了最近的 AdCom,也考慮了最近的 FDA 的持續興趣,以顯示新藥物成分在 PD-1 之上的貢獻,並顯示總體生存率和使用平台總體生存率表明,當您添加更多東西時,您在總體生存率方面將繼續獲得越來越多的好處。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Daina. Next question, please, Brad.

    偉大的。謝謝你,戴娜。請下一個問題,布拉德。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    阿卡什·特瓦里,杰弗里斯。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Hey. Thanks so much. And really helpful color on GARDASIL, just one more here. Looking at the latest Zhifei contract, it looks like there's around $4.5 billion in potential sales for 2024. That's projected to decline in 2025 and 2026 to around $2.5 billion. Historically, however, it looks like you've always exceeded that contracted figure.

    嘿。非常感謝。還有 GARDASIL 上非常有用的顏色,這裡還有一種。從最新的智飛合約來看,2024 年的潛在銷售額約為 45 億美元。然而,從歷史上看,你似乎總是超過這個合約數字。

  • So just to be clear, does the contracted decline in sales over the next two years bake in the upside for potential male approval? And should we expect the Zhifei contract to get renegotiated as we get further clarity on demand? Thanks so much.

    那麼,需要澄清的是,未來兩年合約銷售額的下降是否會為潛在的男性認可帶來好處?隨著我們對需求的進一步明確,我們是否應該期望智飛合約重新談判?非常感謝。

  • Caroline Litchfield - Chief Financial Officer, Executive Vice President

    Caroline Litchfield - Chief Financial Officer, Executive Vice President

  • Thank you for the question. So the Zhifei contract that we have at this stage is focused on the current approval that we have in the market. So it's really focused on the female population in the age cohort 9 through 45. As we move forward and we have a male indication, we will, of course, be working with our partner to have the appropriate doses so that we can protect as many males as possible.

    感謝你的提問。所以我們現階段的智飛合約主要是針對我們目前在市場上獲得的認可。因此,它真正關注的是9 至45 歲年齡層的女性族群。可能多的人男性盡可能。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Akash. Next question, please.

    偉大的。謝謝你,阿卡什。請下一個問題。

  • Operator

    Operator

  • Trung Huynh, UBS.

    Trung Huynh,瑞銀。

  • Trung Huynh - Analyst

    Trung Huynh - Analyst

  • Hi, guys. Thanks for taking my question. Just one on CAPVAXIVE, during the ACIP at the end of June, there was a big discussion on the plus 50 population for the product. They never got around to reviewing it, though. So is it possible we can get that looked at in October for a potential updated recommendation?

    嗨,大家好。感謝您提出我的問題。就CAPVAXIVE上的一個,6月底的ACIP期間,針對該產品的+50人群進行了大討論。但他們從來沒有抽出時間來審查它。那麼我們是否可以在 10 月進行審查,以獲得潛在的更新建議?

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Thank you so much for bringing that up. There was a lot of discussion. There were a lot of points that the ACIP working group had to vote on. And what they had said is that they were very interested in revisiting this in October.

    非常感謝你提出這個問題。大家進行了很多討論。 ACIP 工作小組必須對許多要點進行投票。他們表示,他們非常有興趣在 10 月重新審視這個問題。

  • I want to be very clear that we have not had a formal confirmation of that reevaluation. But we did listen to the discussion, and the discussion was very clear that there was an interest in revisiting that in 50 to 64. And the data presented at the June ACIP meeting demonstrated or actually reinforced the ongoing burden of pneumococcal disease, especially in the 50 to 64 age group, most notably in the racial disparities.

    我想明確表示,我們尚未對重新評估進行正式確認。但我們確實聽取了討論,而且討論非常清楚,有興趣在 50 至 64 年內重新審視這一點。 64歲年齡段,最明顯的是種族差異。

  • Then I went back to the comments that were made by different individuals, but I focused on some of the points that those who actually vote in the ACIP, one resonated with me when that member said, the burden in 50 to 64-year-old black individuals is comparable to greater than 65 when we're all endorsing universal recommendation for over 65. And that member wondered whether we, which is the ACIP, was missing something too by not deciding and that we, the ACIP, needed to decide at some point, and I hope we get there pretty soon, in part because of the racial and ethnic disparities in the invasive disease.

    然後我回到了不同個人發表的評論,但我重點關注了那些真正在 ACIP 中投票的人的一些觀點,當那位成員說“50 至 64 歲的負擔”時,我產生了共鳴。在支持65 歲以上的普遍建議時,黑人相當於65 歲以上。我希望我們很快就能實現這一目標,部分原因是因為這種侵襲性疾病存在種族和民族差異。

  • So we are very confident in our data, and we look forward to the ACIP considering this expanded age-based recommendation, potentially in October. And we hope to find out at some appropriate time that they're going to formally confirm that reevaluation.

    因此,我們對我們的數據非常有信心,我們期待 ACIP 可能在 10 月考慮這一擴大的基於年齡的建議。我們希望在某個適當的時間發現他們將正式確認重新評估。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thanks, Trung. Next question, please, Brad.

    偉大的。謝謝,特朗。請下一個問題,布拉德。

  • Operator

    Operator

  • Louise Chen, Cantor.

    路易絲·陳,康托爾。

  • Louise Chen - Analyst

    Louise Chen - Analyst

  • Hi. Thank you for taking my question here. I wanted to ask you on WINREVAIR. How do you think about sales in the third quarter of '24, given some stocking that we saw this quarter? Thank you.

    你好。感謝您在這裡提出我的問題。我想在 WINREVAIR 上問你。考慮到本季我們看到的一些庫存,您如何看待 24 年第三季的銷售情況?謝謝。

  • Caroline Litchfield - Chief Financial Officer, Executive Vice President

    Caroline Litchfield - Chief Financial Officer, Executive Vice President

  • So thank you for the question, Louise. We feel that we're off to a really strong start with WINREVAIR. As we've described, as at the end of the quarter, we have 2,000 patients who now have the prescription for WINREVAIR, of which 75% to 80% historically have been receiving commercial products.

    謝謝你的提問,路易絲。我們認為 WINREVAIR 為我們帶來了一個非常強勁的開端。正如我們所描述的,截至本季末,我們有 2,000 名患者現在持有 WINREVAIR 處方,其中 75% 至 80% 歷史上一直在接受商業產品。

  • So we're confident in what we expect for the profile for WINREVAIR in the third quarter, and we actually expect that the stock level should increase as more patients are prescribed the product. So we remain confident in the outlook for WINREVAIR, consistent with the high expectations that we have.

    因此,我們對 WINREVAIR 第三季度的業績充滿信心,而且我們實際上預計,隨著更多患者使用該產品,庫存水準應該會增加。因此,我們對 WINREVAIR 的前景仍然充滿信心,這與我們的高期望一致。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Louise. Next question, please, Brad.

    偉大的。謝謝你,路易絲。請下一個問題,布拉德。

  • Operator

    Operator

  • Chris Shibutani, Goldman Sachs.

    克里斯·澀谷,高盛。

  • Chris Shibutani - Analyst

    Chris Shibutani - Analyst

  • Thank you. On business development, this is typically a question that you get posed, in June, you did comment that the company does have an expressed interest in the cardiometabolic space, thinking about second- and third-generation opportunities potentially in weight management. Can you just provide us with the latest health views in terms of appetite, size, therapeutic area and, particularly noting, obesity? Thank you.

    謝謝。在業務發展方面,這通常是您提出的一個問題,六月份,您確實評論說該公司確實對心臟代謝領域表達了興趣,並考慮了體重管理方面潛在的第二代和第三代機會。您能否提供我們關於食慾、體型、治療範圍,特別是肥胖的最新健康觀點?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. No, Chris, thanks for the question. Obviously, we discussed what we did in the quarter with EyeBio and Elanco aqua business, we're going to continue to follow the same strategy we've been looking at, which is really focusing on the science and looking at how can we best continue to drive where we see a scientific opportunity that matches our portfolio and our skill set to bring that in more in the earlier-stage settings and with some mid-late but clearly not commercialized products more to build the pipeline.

    是的。不,克里斯,謝謝你的提問。顯然,我們討論了本季度與 EyeBio 和 Elanco aqua 業務所做的事情,我們將繼續遵循我們一直在考慮的相同策略,即真正關注科學並研究如何最好地繼續下去推動我們看到與我們的產品組合和技能相匹配的科學機會,將其更多地引入早期階段,並與一些中後期但顯然尚未商業化的產品更多地建立管道。

  • So the continuation of the strategy we've been following, we continue to have the financial flexibility to consider deals of all sizes. But as we've pointed out in the past, we tend to look in that $1 billion to $15 billion, a good indication of where we would most likely play.

    因此,為了延續我們一直遵循的策略,我們繼續擁有財務靈活性來考慮各種規模的交易。但正如我們過去指出的那樣,我們傾向於關注 10 億至 150 億美元,這很好地表明了我們最有可能在哪裡進行投資。

  • And to the obesity question specifically, our view continues to be that if we can find opportunities to look at next-generation plays in that space, those will be things we will continue to evaluate and consider. We don't believe going after today's first generation is the place to play. So it will continue to be looking at second- and third-generation waves and innovation, whether it be around oral delivery, looking for where there's high tolerability, combinability, and/or preservation of muscle mass. Those are the areas of focus for us. And if we see something, we continue to have the capacity and the interest to act.

    具體到肥胖問題,我們仍然認為,如果我們能找到機會研究該領域的下一代遊戲,這些將是我們將繼續評估和考慮的事情。我們不認為追隨今天的第一代是可行的。因此,它將繼續關注第二代和第三代浪潮和創新,無論是圍繞口服給藥,尋找具有高耐受性、可組合性和/或保留肌肉質量的地方。這些都是我們關注的領域。如果我們看到了什麼,我們仍然有能力和興趣採取行動。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Chris. Next question, please, Brad.

    偉大的。謝謝你,克里斯。請下一個問題,布拉德。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    特倫斯‧弗林,摩根士丹利。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Great. Thanks for taking the question. Just a two-part on WINREVAIR for me. I was just wondering if you think you've already worked through the initial bolus of patients and kind of late line, or if there's more to go here for the second half. And then any color on background therapy in terms of the patients that have already started on sotatercept? Thank you.

    偉大的。感謝您提出問題。對我來說,關於 WINREVAIR 的內容只有兩個部分。我只是想知道你是否認為你已經完成了最初的病人推注和後期排隊,或者下半年是否還有更多工作要做。那麼對於已經開始使用 sotatercept 的病人來說,背景治療有什麼顏色嗎?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. Maybe I'll start on the second part, and then I'll come back to the first part. So on background therapy, you are seeing the vast majority of patients, as you would expect, are some of the sicker patients or who doctors are putting on the drug first.

    是的。也許我會從第二部分開始,然後再回到第一部分。因此,在背景治療中,正如您所預料的那樣,您看到的絕大多數患者都是病情較重的患者,或者是醫生首先給予藥物的患者。

  • So there is a large amount on triple therapy or double therapy, and you are seeing uses with prostacyclin. So that is -- and frankly consistent with what you would have seen in STELLAR as well, so we are seeing that pretty much as you'd expect. And then over time, we would expect to move into the earlier lines of therapy as we go.

    因此,三聯療法或雙重療法的用量很大,您正在看到前列環素的用途。坦白說,這也與您在 STELLAR 中看到的一致,因此我們所看到的與您所期望的幾乎一致。然後隨著時間的推移,我們預計會進入早期的治療方案。

  • As it relates to what we see going forward with the bolus, I would say that it's not necessary that we think the bolus has been worked through. What I would tell you more broadly is we're seeing a continued growth in both the breadth and the depth of prescribers who are prescribing, which we're at a little over 500 doctors now prescribing.

    由於這與我們對推注的進展有關,我想說,我們沒有必要認為推注已經完成。我想更廣泛地告訴您的是,我們看到開處方的醫生的廣度和深度都在持續增長,目前有 500 多名醫生正在開處方。

  • We think there's probably somewhere in the 800 to 900 range of doctors that are doing the vast majority of prescribing out there. So we still have a ways to go to get to what I would consider to be heavy prescribers of the medicine. And as we see that group continuing to come in, and as we continue to see access being granted, because the other thing I would point out, that one, we feel very good.

    我們認為,絕大多數處方可能由 800 至 900 名醫生負責。因此,我們還有很長的路要走,才能找到我認為的重度處方者。當我們看到該群體繼續進來時,當我們繼續看到訪問被授予時,因為我要指出的另一件事,我們感覺非常好。

  • We have about a third of all lives are covered today under a medical plan with a protocol in place for reimbursement related to WINREVAIR. We expect that to continue to grow, because I would remind you that a lot of plans actually put in place just by the rule that they will wait 90 to 120 days-ish to put in place a plan, a coverage plan, after a drug is launched.

    今天,我們約有三分之一的生命受到醫療計畫的保障,並制定了與 WINREVAIR 相關的報銷協議。我們預計這一數字會繼續增長,因為我想提醒您,許多計劃實際上只是按照規則制定的,即在服用藥物後要等待 90 到 120 天左右才能製定計劃、承保計劃已推出。

  • So you have a lot of plans still yet to come. So because of the fact you're going to see increasing access, you're going to see the fact that we have increasing number of physicians, and we're going to continue to see the breadth of patients grow, I think you're going to see continued trend for growth upward.

    所以你還有很多計劃尚未實現。因此,由於您將看到越來越多的訪問機會,您將看到我們擁有越來越多的醫生,並且我們將繼續看到患者的範圍不斷擴大,我認為您是將看到持續向上的成長趨勢。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Terence. Next question, please.

    偉大的。謝謝你,特倫斯。請下一個問題。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    Evan Seigerman,BMO 資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Hi, guys. Thank you so much for the update today. So given the interest in the schizophrenia space with the number of readouts coming in the second half of the year, can you characterize what we should expect from your Phase 2b trial of MK-8189? It looks like the study completed back in June. Just wondering when we might see the data and kind of how we should be comping this to the novel developments in the space.

    嗨,大家好。非常感謝您今天的更新。因此,考慮到人們對精神分裂症領域的興趣以及今年下半年的讀數數量,您能否描述一下我們對 MK-8189 2b 期試驗的預期?看起來這項研究早在六月就完成了。只是想知道我們什麼時候可以看到這些數據,以及我們應該如何將其與該領域的新穎發展進行比較。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • Yeah. So this is Dean. Thank you very much for that neuroscience question for MK-8189. I should just point out that I believe it was just in May that we published the Phase 2a, and it shows its efficacy in relationship to schizophrenia.

    是的。這就是迪恩。非常感謝您提出 MK-8189 的神經科學問題。我想指出的是,我相信我們在 5 月發布了 2a 期臨床試驗,它顯示了它在治療精神分裂症方面的功效。

  • But what was also interesting was that there was a reduction in body weight of around 6 pounds over just four weeks. And the reason why that's important is that, oftentimes, it's not simply how efficacious the drug is; it's whether a patient will stay on and what are the adverse effects that will drive a patient not to take the drug. So that Phase 2a was really important. That triggered the Phase 2b. So I'll just lay out that if we see things that are comparable to that Phase 2a and our Phase 2b, we would be eager to see such results.

    但同樣有趣的是,短短 4 週內體重就減少了約 6 磅。這之所以重要是因為,通常情況下,這不僅僅是藥物的有效性;而是藥物的有效性。問題在於患者是否會繼續用藥,以及哪些不良反應會導致患者不服藥。所以第 2a 階段非常重要。這觸發了階段 2b。因此,我只想指出,如果我們看到與第 2a 階段和第 2b 階段類似的東西,我們會渴望看到這樣的結果。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, Evan. Brad, one more question, please.

    偉大的。謝謝你,埃文。布拉德,還有一個問題。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    詹姆斯‧辛,德意志銀行。

  • James Shin - Analyst

    James Shin - Analyst

  • Good morning. Thank you for the question. For WINREVAIR, is the conversion of the 75% to 80% of scripts into commercial embedded within fiscal year '24 guide? And quickly, is there any timeline on the INTerpath filing? Thank you.

    早安.感謝你的提問。對於 WINREVAIR,是否將 75% 到 80% 的腳本轉換為嵌入在 24 財年指南中的廣告?請問 INTERpath 備案有時間表嗎?謝謝。

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • So the answer to your first question is yes. And the answer to the second question, I would let Dean address.

    所以你的第一個問題的答案是肯定的。第二個問題的答案,我會讓迪恩來回答。

  • Dean Li - Executive Vice President, President - Merck Research Laboratories

    Dean Li - Executive Vice President, President - Merck Research Laboratories

  • So in relationship to our collaboration with Moderna, in relationship to the INT, that's something that we're focused on getting the Phase 3 fully enrolled and to move forward, as that's really important in relationship to how we will see the program and how the FDA will see that program.

    因此,就我們與 Moderna 的合作以及與 INT 的關係而言,我們的重點是讓第 3 階段完全註冊並向前推進,因為這對於我們如何看待該計劃以及如何看待該計劃非常重要。到該計劃。

  • Peter Dannenbaum - IR

    Peter Dannenbaum - IR

  • Great. Thank you, James, and thank you all for your good questions today. As always, the IR team is available for any follow-up questions.

    偉大的。謝謝詹姆斯,也謝謝大家今天提出的好問題。像往常一樣,投資者關係團隊可以解答任何後續問題。

  • Rob, any closing comments that you'd like to make?

    羅布,您想發表任何結束語嗎?

  • Robert Davis - Chairman of the Board, President, Chief Executive Officer

    Robert Davis - Chairman of the Board, President, Chief Executive Officer

  • Yeah. No, I just want to thank you for your interest this morning. Hopefully, you appreciate the transparency with which we tried to bring.

    是的。不,我只是想感謝您今天早上的關注。希望您能欣賞我們努力帶來的透明度。

  • But I maybe would close by just bringing back the confidence we see in the business, both in the short term and the long term. Obviously, we'll work through what we see happening with GARDASIL in China. But the fact that we see strengthening, and I would call them green shoots, around GARDASIL everywhere else in the world gives us confidence in the $11 billion for that, as we've talked about.

    但我也許會以恢復我們對業務的短期和長期信心作為結束語。顯然,我們將解決我們所看到的 GARDASIL 在中國發生的情況。但事實上,我們看到 GARDASIL 在世界其他地方的實力不斷增強,我稱之為萌芽,這一事實讓我們對 110 億美元的資金充滿信心,正如我們所討論的那樣。

  • But then beyond that, the growing breadth of our pipeline, obviously, KEYTRUDA continues to deliver meaningfully for the business and for patients. But I am growing in my own excitement for the breadth and depth of the pipeline we have coming. Hopefully, it wasn't lost on everyone that we pointed out we would be launching more drugs in the next five years than we've launched in the last 10, many, many of which will be blockbuster plus opportunities.

    但除此之外,我們的產品線不斷擴大,顯然 KEYTRUDA 繼續為企業和患者提供有意義的服務。但我對我們即將推出的管道的廣度和深度感到越來越興奮。希望每個人都沒有忘記,我們指出,我們將在未來五年內推出比過去 10 年推出更多的藥物,其中許多將是重磅炸彈和機會。

  • So the pipeline is maturing, and we're starting to see the green shoots of opportunity that continue to grow our confidence as we look to 2028 and to the 2030s and beyond. And that's where we will continue to focus. But we will not take our eye off the short term, where we are equally confident in the guidance. We raised revenue today. Obviously, we kind of were neutral on earnings, but that's because of the investment we're making into the business, bringing in even more opportunities like EyeBio.

    因此,管道正在成熟,我們開始看到機會的萌芽,當我們展望 2028 年、2030 年代及以後時,這些機會將繼續增強我們的信心。這就是我們將繼續關注的地方。但我們不會將目光從短期上移開,我們對這指引同樣充滿信心。我們今天增加了收入。顯然,我們對獲利持中性態度,但這是因為我們對業務進行了投資,帶來了更多像 EyeBio 這樣的機會。

  • So there's a lot out there, and I just want to leave you with that note of what's driving my confidence and my appreciation for your support of the stock. Thank you.

    因此,有很多東西,我只想給你們留下一句話,說明是什麼推動了我的信心,並感謝你們對股票的支持。謝謝。