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Operator
Operator
Good day, and thank you for standing by. Welcome to the Moderna third quarter 2025 conference call. (Operator Instructions)
您好,感謝您的耐心等待。歡迎參加 Moderna 2025 年第三季業績電話會議。(操作說明)
Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.
請注意,今天的會議正在錄影。現在我謹將會議交給今天的演講嘉賓拉維娜·塔盧克達爾。請繼續。
Lavina Talukdar - Head of Investor Relations
Lavina Talukdar - Head of Investor Relations
Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's third quarter 2025 and financial results and business updates. You can access the press release issued this morning as well as the slides that we will be reviewing by going to the Investors section of our website. On today's call are Stephane Bancel, our Chief Executive Officer; Stephen Hoge, our President; and Jamey Mock, our Chief Financial Officer.
謝謝你,凱文。各位早安,感謝各位參加今天的電話會議,共同討論 Moderna 2025 年第三季及財務業績和業務最新進展。您可以透過造訪我們網站的「投資者」版塊,查看今天早上發布的新聞稿以及我們將要審查的幻燈片。今天參加電話會議的有:執行長 Stephane Bancel;總裁 Stephen Hoge;以及財務長 Jamey Mock。
Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.
在會議開始之前,請注意,本次電話會議將包含根據 1995 年《私人證券訴訟改革法案》安全港條款所做的前瞻性陳述。請參閱隨附簡報的第 2 頁以及我們向美國證券交易委員會提交的文件,以了解可能導致我們的實際業績和結果與這些前瞻性聲明中明示或暗示的內容存在重大差異的重要風險因素。
With that, I will turn the call over to Stephane.
接下來,我將把電話交給史蒂芬。
Stephane Bancel - Chief Executive Officer, Director
Stephane Bancel - Chief Executive Officer, Director
Thank you, Lavina. Hello, everyone. Thank you for joining us today. I will start with a quick review of the quarter. Jamey will present our financial results and outlook, Stephen will review our commercial progress, and clinical programs and then I will share our key value drivers as we look ahead before we take your questions.
謝謝你,拉維娜。大家好。感謝您今天蒞臨。我將首先對本季度進行簡要回顧。Jamey 將介紹我們的財務表現和展望,Stephen 將回顧我們的商業進展和臨床項目,然後我將分享我們展望未來的關鍵價值驅動因素,之後我們將回答大家的問題。
In the third quarter, our revenue were $1 billion, driven by sales of our free approved vaccines, Spikevax (inaudible). The net loss for the quarter was $200 million. We ended the quarter with $6.6 billion in cash and investments. We remain highly focused on financial discipline. I'm pleased to announce that continued cost reduction efforts across the company in the third quarter of 2025 led to a 34% reduction of cost of sales, R&D and SG&A combined compared to the third quarter of 2024.
第三季度,我們的營收達到10億美元,主要得益於我們免費核准疫苗Spikevax的銷售。(聽不清楚)本季淨虧損為2億美元。本季末,我們擁有66億美元的現金和投資。我們始終高度重視財務紀律。我很高興地宣布,公司在 2025 年第三季持續推進成本削減工作,使得銷售成本、研發成本和銷售、管理及行政費用合計比 2024 年第三季降低了 34%。
During the quarter, we made good progress across our three strategic priorities. Our first priority is driving use of our commercial products. For Spikevax, our original COVID vaccine, we received approval in 40 countries for the seasonal 2025-2026 train update. And (inaudible), our new COVID vaccine was approved this year by the FDA. We also filed and received approval for the 2025-2026 strand update in the US, making this the first season that mNEXSPIKE is available in the United States. We also received approval for mNEXSPIKE in Canada.
本季度,我們在三大戰略重點領域均取得了良好進展。我們的首要任務是推動我們商業產品的使用。對於我們最初的 COVID 疫苗 Spikevax,我們已在 40 個國家/地區獲得批准,用於 2025-2026 年的季節性疫苗更新。(聽不清楚)我們的新冠疫苗今年獲得了美國食品藥物管理局的批准。我們也向美國提交了 2025-2026 年的品種更新申請,並獲得了批准,這使得 mNEXSPIKE 首次在美國上市。mNEXSPIKE 也獲得了加拿大的批准。
For (inaudible) vaccine, mRESVIA will continue to gain regulatory approval and mRESVIA is now approved in 40 countries. We have a strategic partnership with three countries, Canada, the UK and Australia, where we have established manufacturing facilities and secured a multiyear offtake agreements. In each of these countries, we have achieved important milestones. In Canada, we delivered the first made in Canada, mRNA vaccines to the Canadian government for used this season. In the UK and Australia, our facilities were granted licenses by their respective regulatory agencies.
對於(聽不清楚)疫苗,mRESVIA 將繼續獲得監管部門的批准,目前 mRESVIA 已在 40 個國家獲得批准。我們與加拿大、英國和澳洲三個國家建立了戰略合作夥伴關係,在這些國家我們建立了生產設施並簽訂了多年承購協議。在這些國家,我們都取得了重要的里程碑式成就。在加拿大,我們向加拿大政府交付了首批加拿大製造的mRNA疫苗,供本季使用。在英國和澳大利亞,我們的設施均已獲得各自監管機構頒發的許可證。
Second priority, advancing pipeline to grab sales growth. We announced in July, positive Phase III full efficacy data which we believe will advance both our flu vaccine program, mRNA-1010 and our flu plus COVID combination program, mRNA-1083. For the flu plus COVID combination program, our filing continues to be under review by the European Medicines Agency.
第二要務,推動銷售通路建設,以實現銷售成長。我們在 7 月公佈了積極的 III 期完全療效數據,我們相信這將推進我們的流感疫苗計畫 mRNA-1010 和流感加 COVID 聯合疫苗計畫 mRNA-1083。對於流感加新冠聯合療法項目,我們的申請仍在接受歐洲藥品管理局的審查。
In Oncology portfolio at the European Society of Medical Oncology, ESMO, Congress in October, we presented encouraging Phase Ib data for cancer antigen therapy, mRNA-4359. Unfortunately, we also announced recently that despite the progress made by the Safety Community in understanding the CMV virus, our CMV program did not meet its primary efficacy endpoints for (inaudible). We will discontinue the development of our CMV vaccine in this indication.
在 10 月舉行的歐洲腫瘤內科學會 (ESMO) 大會上,我們在腫瘤產品組合中展示了癌症抗原療法 mRNA-4359 的令人鼓舞的 Ib 期數據。不幸的是,我們最近也宣布,儘管安全界在了解鉅細胞病毒 (CMV) 方面取得了進展,但我們的 CMV 計畫並未達到其主要療效終點。(聽不清楚)我們將停止針對該適應症的 CMV 疫苗的研發。
Third priority, executing with financial discipline. The team continues to diligently advance our cost improvement program. Over the last four quarters, Q4 2024 to Q3 2025, we delivered a $2.1 billion improvement in costs across cost of goods, SG&A and R&D versus the prior four quarters. I want to thank the entire Moderna team for this great achievement, and we continue to work on prioritizing our ID pipeline, growing productivity equaling by the use of more digital tools including a large number of GPs, also better pricing with our suppliers across the entire company.
第三要務,嚴格執行財務紀律。團隊將繼續努力推進成本改進計劃。從 2024 年第四季到 2025 年第三季度,在過去的四個季度中,我們在商品成本、銷售、一般及行政費用和研發費用方面實現了 21 億美元的成本改善,與前四個季度相比。我要感謝 Moderna 團隊的這項偉大成就,我們將繼續努力,優先發展我們的 ID 流程,透過使用更多數位工具(包括大量全科醫生)來提高生產力,並在全公司範圍內與供應商協商更優惠的價格。
Thanks to this good progress and momentum, we've reduced projected 2025 cash cost by approximately $500 million since just the last quarter investor call in August 2025, and by approximately $900 million since the beginning of the year.
由於取得了良好的進展和勢頭,自 2025 年 8 月上一次季度投資者電話會議以來,我們已將 2025 年預計現金成本減少了約 5 億美元,自年初以來已減少了約 9 億美元。
With this, I will hand over to Jamey.
接下來,我會把工作交給傑米。
James Mock - Chief Financial Officer
James Mock - Chief Financial Officer
Thanks, Stephane, and hello, everyone. Today, I will provide an overview of our financial results for the third quarter and share our outlook for the remainder of 2025. Let's start by reviewing our commercial performance, which you can follow on slide 7.
謝謝斯蒂芬,大家好。今天,我將概述我們第三季的財務業績,並分享我們對 2025 年剩餘時間的展望。讓我們先來回顧一下我們的商業業績,您可以在第 7 頁投影片中查看。
Year-to-date, total revenue was approximately $1.3 billion, with $900 million from the US and the remainder from international markets. In addition to product sales, revenue also includes collaboration, grant and stand ready revenue associated with our strategic partnerships.
今年迄今為止,總收入約為 13 億美元,其中 9 億美元來自美國,其餘則來自國際市場。除了產品銷售收入外,收入還包括與我們的策略合作夥伴關係相關的合作收入、撥款收入和現貨收入。
For the third quarter of 2025, our total revenue was $1 billion, US revenue was $800 million in the third quarter, the vast majority of which was from our COVID vaccines, which included the successful launch of our new COVID vaccine, mNEXSPIKE. Stephen will give more detail on the US COVID vaccination season at a moment.
2025 年第三季度,我們的總收入為 10 億美元,美國收入為 8 億美元,其中絕大部分來自我們的新冠疫苗,包括成功推出我們的新新冠疫苗 mNEXSPIKE。史蒂芬稍後將詳細介紹美國新冠疫苗接種季的情況。
Revenue outside the US was $200 million. Approximately half of international revenue in Q3 was delivered to Canada. -- where we began executing on our strategic partnership through our in-country manufacturing facility. As a reminder, we have similar strategic partnerships with the Australian and UK governments and expect to begin shipping locally manufactured product in 4Q '25 and 1Q '26, respectively.
美國以外的收入為2億美元。第三季國際收入約有一半來自加拿大——我們已開始透過我們在加拿大的本土製造工廠落實我們的戰略合作夥伴關係。再次提醒大家,我們與澳洲和英國政府建立了類似的戰略合作夥伴關係,預計將分別於 2025 年第四季和 2026 年第一季開始交付本地製造的產品。
For the full year 2025 outlook, we are narrowing our revenue range to $1.6 billion to $2 billion from our previous guidance of $1.5 billion to $2.2 billion. For the US market, we expect fourth quarter sales of $100 million to $400 million. This would bring our updated full year US revenue guidance to $1 billion to $1.3 billion versus our prior guidance of $1 billion to $1.5 billion.
對於 2025 年全年展望,我們將營收範圍從先前的 15 億美元至 22 億美元下調至 16 億美元至 20 億美元。對於美國市場,我們預計第四季銷售額為 1 億美元至 4 億美元。這將使我們更新後的全年美國營收預期從先前的 10 億美元至 15 億美元調整為 10 億美元至 13 億美元。
Our original guidance assumed year-over-year revenue to be flat to down 33%, excluding onetime items. Our updated guidance now assumes a year-over-year decline of 15% to 33%. COVID vaccination rates remain the largest variable to this range, which Stephen will walk through in a moment.
我們最初的預期是,不計一次性項目,年比收入將持平或下降 33%。我們更新後的預期是年減 15% 至 33%。新冠疫苗接種率仍然是影響這一範圍的最大變量,史蒂芬稍後會詳細講解。
For international markets, we now expect revenue to be between $300 million and $400 million in the fourth quarter, bringing the full year to $600 million to $700 million versus our previous guidance of $500 million to $700 million. We have a tighter range on our international sales as most of these sales are for contracted volumes leaving delivery timing and file vaccination rates as the only remaining variables. Moving to slide 8, I will review our 3Q financial results in more detail.
對於國際市場,我們現在預計第四季營收將在 3 億至 4 億美元之間,使全年營收達到 6 億至 7 億美元,而我們先前的預期為 5 億至 7 億美元。由於國際銷售大多是按合約數量進行的,因此我們的國際銷售範圍更窄,剩下的唯一變數就是交貨時間和疫苗接種率。接下來,我將在第 8 張投影片中更詳細地回顧我們第三季的財務表現。
Total revenue was $1 billion in the quarter, as I just discussed on the prior page. We had net product sales of $973 million and other revenue of $43 million from grants, collaborations, royalties and stand ready fees. The 45% year-over-year decline in revenue was expected and primarily reflects lower COVID vaccine demand.
正如我在上一頁中提到的,該季度總收入為 10 億美元。我們的淨產品銷售額為 9.73 億美元,其他收入為 4,300 萬美元,包括撥款、合作、版稅和備貨費。營收年減 45% 在意料之中,主要反映出新冠疫苗需求下降。
It's also worth noting that last year's third quarter included approximately $140 million from a true-up adjustment to prior period sales provisions. That benefit did not repeat in Q3 this year. Cost of sales for the third quarter was $207 million, representing 21% net product sales for the quarter. This was a 60% year-over-year decrease in our cost of sales from $514 million in Q3 last year.
值得注意的是,去年第三季包含了約 1.4 億美元的前期銷售準備金的調整。今年第三季度,這一優勢並未再次出現。第三季的銷售成本為 2.07 億美元,佔該季淨產品銷售額的 21%。與去年第三季的 5.14 億美元相比,我們的銷售成本年減了 60%。
The improvement was driven by lower inventory write-downs, reduced unutilized manufacturing capacity and lower volume. Overall, these results reflect the productivity gains and the efficiency improvements we've achieved in our manufacturing operations.
績效改善的驅動因素包括庫存減損減少、閒置產能降低和銷售下降。整體而言,這些結果反映了我們在生產營運中所取得的生產力提升和效率提升。
R&D expenses in the third quarter were $801 million, a 30% decrease from last year. The reduction mainly reflects lower clinical trial costs as we completed several large Phase III studies in our vaccine portfolio as well as efficiency gains across the organization. Last year's results also included an expense related to the purchase of a priority review voucher.
第三季研發支出為 8.01 億美元,比去年同期下降 30%。成本降低主要反映了臨床試驗成本的降低,因為我們完成了疫苗產品組合中的幾項大型 III 期研究,以及整個組織效率的提升。去年的業績還包括與購買優先審核券相關的支出。
SG&A expenses were $268 million in the third quarter, a 5% decrease year over year. The decline mainly reflects lower consulting and external service costs across multiple functions, along with reduced digital and facility spending. These savings reflect the cost discipline we've built into the organization and our continued focus on streamlining how we operate.
第三季銷售、一般及行政費用為 2.68 億美元,較去年同期下降 5%。這一下降主要反映了多個職能部門的諮詢和外部服務成本降低,以及數位化和設施支出減少。這些節省反映了我們在組織內部建立的成本控制意識,以及我們對簡化營運方式的持續關注。
Our income tax provision for the quarter was immaterial, consistent with the prior year. We continue to maintain a global valuation allowance against the majority of our deferred tax assets, which limits our ability to recognize tax benefits from losses.
本季我們的所得稅準備金微不足道,與去年同期一致。我們繼續對大部分遞延所得稅資產提列全球估值準備,這限制了我們從虧損中確認稅收優惠的能力。
Net loss for the quarter was $200 million compared to net income of $13 million in Q3 2024. Loss per share was $0.51 compared to earnings per share of $0.03 last year. We ended Q3 with cash and investments of $6.6 billion, down from $7.5 billion at the end of Q2. The decrease was primarily driven by seasonal impact to working capital. With that, let me take a minute to share the progress we've made on our cost reduction goals.
本季淨虧損為 2 億美元,而 2024 年第三季淨利為 1,300 萬美元。本年度每股虧損0.51美元,去年同期每股獲利0.03美元。第三季末,我們的現金和投資為 66 億美元,低於第二季末的 75 億美元。下降的主要原因是季節性因素對營運資金的影響。接下來,請容許我花一分鐘時間向大家介紹我們在降低成本目標方面的進展。
As a reminder, our original target this year was to reduce our GAAP operating expenses from $7.2 billion in 2024 to $6.4 billion in 2025. On a cash cost basis, excluding stock-based compensation, depreciation and other non-cash charges, that represented a decrease from $6.3 billion in 2024 to $5.5 billion. I'm happy to report that we are now on track to beat our 2025 cost plan by over $1 billion on a GAAP basis and by $900 million on a cash cost basis, both at the midpoint of our projections.
提醒一下,我們今年的原定目標是將 GAAP 營運費用從 2024 年的 72 億美元減少到 2025 年的 64 億美元。以現金成本計算,不包括股票選擇權費用、折舊和其他非現金支出,這意味著從 2024 年的 63 億美元減少到 55 億美元。我很高興地報告,我們現在預計將按 GAAP 準則將 2025 年的成本計劃節省超過 10 億美元,按現金成本計算則節省 9 億美元,這兩個數字均取我們預測的中點。
During our previous 2Q call, we have lowered our GAAP and cash cost by $400 million each, with GAAP costs lowered from $6.4 billion to $6 billion, and cash costs lowered from $5.5 billion to $5.1 billion. Today, we are further lowering our 2025 expense guidance due to additional progress across the company to drive efficiency gains and continued investment prioritization.
在我們先前第二季的電話會議上,我們將 GAAP 成本和現金成本分別降低了 4 億美元,其中 GAAP 成本從 64 億美元降至 60 億美元,現金成本從 55 億美元降至 51 億美元。今天,由於公司在提高效率和持續優先投資方面取得了進一步進展,我們進一步下調了 2025 年的支出預期。
Our GAAP operating expense guidance is being reduced by another $700 million from $6 billion to $5.3 billion at the midpoint. This reduction is $500 million of cash costs, plus $200 million of non-cash reductions in stock-based compensation and depreciation.
根據美國通用會計準則 (GAAP),我們的營運費用預期將再減少 7 億美元,從 60 億美元降至 53 億美元(中位數)。此次削減包括 5 億美元的現金成本,以及 2 億美元的非現金削減,包括股票選擇權費用和折舊。
The $700 million GAAP reduction from prior guidance is split evenly between cost of sales and R&D. We are lowering our cost of sales forecast by $300 million to $400 million from $1.2 billion to a range of $0.8 billion to $0.9 billion, which reflects an acceleration of the efficiency programs we are targeting as part of our multiyear cost-out plan. We are also lowering our R&D expense range to $3.3 billion to $3.4 billion and approximately $350 million improvement due to continued investment prioritization and efficiency gains in the execution of our clinical trials.
與先前的預期相比,GAAP 準則下的 7 億美元減少額平均分配給了銷售成本和研發成本。我們將銷售成本預測從 12 億美元下調 3 億美元至 4 億美元,降至 8 億美元至 9 億美元之間,這反映出我們正在加速推進的效率提升計劃,這是我們多年成本削減計劃的一部分。我們同時將研發支出範圍下調至 33 億至 34 億美元,由於持續的投資優先排序和臨床試驗執行效率的提高,節省了約 3.5 億美元。
In just two years, we expect to reduce our cash cost by approximately 50% from nearly $9 billion in 2023 and to $4.6 billion in 2025. We are now ahead of our plans, and we'll update improvements to our 2026 and 2027 targets at our upcoming Analyst Day on November 20.
我們預計在短短兩年內,現金成本將減少約 50%,從 2023 年的近 90 億美元降至 2025 年的 46 億美元。我們現在的進度已經超過了計劃,我們將在 11 月 20 日舉行的分析師日上更新 2026 年和 2027 年目標的改進情況。
Importantly, we continue to target cash breakeven in 2028. I would like to take this moment to thank all my Moderna colleagues for their hard work and commitment to improve the financial profile of our company. Moving to Slide 10. I will share our updated 2025 financial framework.
重要的是,我們仍將目標設定為在 2028 年實現現金收支平衡。我想藉此機會感謝所有 Moderna 的同事們,感謝他們為改善我們公司的財務狀況所付出的辛勤努力和奉獻精神。切換到第10張投影片。我將分享我們更新的2025年財務架構。
For total revenue, as I mentioned in my earlier remarks, we are narrowing our range to $1.6 billion to $2 billion from our previous guidance of $1.5 billion to $2.2 billion. For cost of sales, our updated guidance is $0.8 billion to $0.9 billion, an improvement from our previous guidance of $1.2 billion. This updated range assumes a higher cost of sales in 4Q versus 3Q, which factors in similar sales volume and higher unutilized manufacturing charges. Newly introduced tariffs are not expected to have a material impact on our business, but we continue to monitor changes to global tariffs.
至於總收入,正如我之前提到的,我們將預期範圍從先前的 15 億美元至 22 億美元縮小到 16 億美元至 20 億美元。對於銷售成本,我們更新後的預期為 8 億美元至 9 億美元,比我們先前預期的 12 億美元有所改善。此次更新後的預測範圍假設第四季度的銷售成本高於第三季度,這考慮到了相似的銷售量和更高的未利用製造費用。新推出的關稅預計不會對我們的業務產生實質影響,但我們會繼續關注全球關稅的變化。
Our revised R&D range of $3.3 billion to $3.4 billion, projects an increase in 4Q spend due to the seasonality of vaccine trial spend as well as studies in support of regulatory approvals. SG&A expenses are expected to be $1.1 billion. Similar to last year, we expect SG&A expenses in the fourth quarter to increase primarily due to commercial related activity. We expect taxes to be negligible in 2025. We expect our capital expenditures are also supposed to be approximately $300 million.
我們修訂後的研發預算範圍為 33 億美元至 34 億美元,預計第四季度支出將增加,原因是疫苗試驗支出具有季節性,以及為獲得監管部門批准而進行的研究。預計銷售、管理及行政費用為11億美元。與去年類似,我們預期第四季銷售、一般及行政費用將增加,主要原因是商業相關活動。我們預計到 2025 年稅收將微乎其微。我們預計資本支出也約為 3 億美元。
We are increasing our year-end cash guidance to $6.5 billion to $7 billion, an increase of $0.5 billion to $1 billion from our prior guidance of approximately $6 billion. This increase is projected to increase year-end cash due to the reduction in our operating expense for the year.
我們將年底現金流預期上調至 65 億至 70 億美元,比先前預期的約 60 億美元增加了 5 億至 10 億美元。由於本年度營運費用減少,預計這一增長將增加年末現金流。
In summary, we have made strong financial progress against our 2025 financial objectives. We have tightened our sales range because of increased visibility into our seasonal sales. And we have lowered our 2025 cash cost estimate by $900 million from $5.5 billion to $4.6 billion, resulting in a higher projected year-end cash balance of $6.5 billion to $7 billion.
總而言之,我們在實現 2025 年財務目標方面取得了顯著的財務進展。由於季節性銷售情況更加明朗,我們收緊了銷售範圍。我們將 2025 年現金成本估算從 55 億美元下調了 9 億美元至 46 億美元,使預計年末現金餘額增加到 65 億美元至 70 億美元。
With that, I will now turn the call over to Stephen.
接下來,我將把電話交給史蒂芬。
Stephen Hoge - President
Stephen Hoge - President
Thank you, Jamey, and good morning or good afternoon, everyone. Today, I'll review our current commercial positioning in the US as well as our progress across our pipeline. As you know, COVID vaccine sales still represent the vast majority of our revenues. And as Jamey pointed out earlier, the US is our largest market in 2025.
謝謝你,傑米,大家早安/下午好。今天,我將回顧我們目前在美國的商業定位以及我們在產品線中的進展。如您所知,新冠疫苗的銷售額仍占我們收入的絕大部分。正如傑米之前指出的那樣,到 2025 年,美國將成為我們最大的市場。
Slide 12 reviews the US COVID vaccination market during the fall of '24 and the cumulative vaccinations to date for the retail channel for the fall of '25 as reported by IQVIA. As a reminder, the retail channel represented 72% of the total vaccinations in the fall of 2024. We expect this segment will represent a similar proportion of the market in 2025.
第 12 張投影片回顧了 2024 年秋季美國新冠疫苗市場的情況,以及 IQVIA 報告的 2025 年秋季零售通路的累積疫苗接種情況。提醒大家,2024 年秋季,零售通路佔疫苗總接種量的 72%。我們預計到 2025 年,這一細分市場將佔市場份額的類似比例。
As Jamey noted earlier, our US revenue guidance is $1.0 billion to $1.3 billion. This range is based on our pre-season expectation for a 20% to 40% decline from fall 2024 retail vaccinations of approximately $26 million. As of October 24, of this year, cumulative retail vaccinations were $13.2 million, down approximately 30% year over year and well within the 20% to 40% decline we had assumed in our 2025 U.S. revenue outlook. Moving to Slide 13.
正如 Jamey 之前提到的,我們對美國市場的收入預期為 10 億美元至 13 億美元。這一範圍是基於我們季前預期,即 2024 年秋季零售疫苗接種額將下降 20% 至 40%,約 2,600 萬美元。截至今年 10 月 24 日,累計零售疫苗收入為 1,320 萬美元,年減約 30%,遠低於我們在 2025 年美國收入展望中假設的 20% 至 40% 的降幅。切換到第13張投影片。
Our COVID retail market share is 42%, up 2 percentage points from last year. We are most pleased by the strong market uptake for mNEXSPIKE even given a midyear launch. mNEXSPIKE now makes up 55% of our COVID vaccination volume.
我們的新冠疫情零售市場佔有率為 42%,比去年增長了 2 個百分點。我們對mNEXSPIKE在年中上市後依然取得的強勁市場反應感到非常滿意。目前,mNEXSPIKE已占我們新冠疫苗接種總量的55%。
Slide 14 is a summary of our prioritized pipeline. This pipeline now consists of 3 approved products, 2 programs with positive Phase III results and 5 more candidates in clinical studies with registrational potential. Moving to Slide 15, which outlines the latest developments in our late-stage respiratory portfolio, I think to start with our COVID vaccines.
第 14 張投影片總結了我們優先考慮的流程。目前該研發管線包括 3 款已獲批准的產品、2 個具有積極 III 期試驗結果的項目以及 5 個正在進行臨床研究且具有註冊潛力的候選產品。接下來是第 15 張投影片,其中概述了我們後期呼吸系統產品組合的最新進展,我認為應該從我們的 COVID 疫苗開始。
As mentioned earlier, Spikevax updated 2025, 2026 formula is now approved in 40 countries. For mNEXSPIKE, we received approval for the '25, '26 formula in the US And we are also approved in Canada. We have also applied for approval in Europe, Australia, Taiwan and Japan and would expect to launch in those countries in the '26, '27 seasons.
如前所述,Spikevax 更新後的 2025 年、2026 年配方現已在 40 個國家獲得批准。mNEXSPIKE 的 '25、'26 配方已在美國獲得批准,並且在加拿大也獲得了批准。我們也向歐洲、澳洲、台灣和日本申請了批准,預計將在 2026 年和 2027 年賽季在這些國家推出。
For mRESVIA, our RSV vaccine, it has been approved for adult age 60 and older in 40 countries and also approved for high-risk adults aged 18 to 59 in 31 of those 40 countries. We recently presented multiple data sets from the mRESVIA clinical program at ID Week.
我們的 RSV 疫苗 mRESVIA 已在 40 個國家獲準用於 60 歲及以上成年人,並在其中 31 個國家獲準用於 18 至 59 歲的高危險群成年人。我們最近在 ID Week 上展示了來自 mRESVIA 臨床專案的多個資料集。
For our flu vaccine candidate, mRNA-1010, we expect to complete regulatory submissions for approval in the United States, Canada, Australia and Europe by January 2026. The positive results from our Phase III vaccine efficacy trial were presented at both ID Week and the European Scientific Working Group on influenza or as we, this past month. Moving on to mRNA-1083, our combination flu covid vaccine candidate.
對於我們的流感疫苗候選產品 mRNA-1010,我們預計將於 2026 年 1 月完成在美國、加拿大、澳洲和歐洲的監管批准申請。上個月,我們在 ID Week 和歐洲流感科學工作小組會議上公佈了我們 III 期疫苗有效性試驗的正面結果。接下來是mRNA-1083,我們的流感新冠聯合疫苗候選產品。
Our filing for approval is under review with the European Medicines Agency. And we expect to refile with Health Canada by the end of 2025. In the US, we are awaiting further guidance from the FDA on our plans to refile. We presented Phase III immunogenicity subanalysis for our flu COVID combination program at (inaudible). Now turning to our non-respiratory vaccine and rare disease portfolios.
我們的審批申請正在接受歐洲藥品管理局的審查。我們預計將於 2025 年底前向加拿大衛生部重新提交申請。在美國,我們正在等待FDA就我們的重新申請計劃提供進一步指導。我們展示了流感-COVID聯合療法計畫的III期免疫原性亞組分析結果。(聽不清楚)現在讓我們來看看我們的非呼吸道疫苗和罕見疾病產品組合。
Our ongoing Phase III norovirus study has not yet accrued sufficient cases needed to conduct the interim analysis after the first season. And as a result, we will proceed to enroll a second Northern Hemisphere season this winter. As before, the timing of the Phase III readout will be dependent upon accruing sufficient cases to trigger the interim analysis.
我們正在進行的諾羅病毒 III 期研究尚未累積到足夠的病例,因此無法在第一季結束後進行中期分析。因此,我們將繼續推動今年冬季北半球第二季的招生工作。與先前一樣,第三階段結果公佈的時間將取決於是否累積了足夠的病例來觸發中期分析。
For mRNA-1647, as we announced in late October, we did not meet the primary endpoint for prevention of infection in our Phase III CMV efficacy study. We are discontinuing development in congenital CMV. However, we will continue to evaluate mRNA-1647 in an ongoing Phase II trial in patients who are undergoing bone marrow transplantation.
正如我們在 10 月下旬宣布的那樣,mRNA-1647 在 III 期 CMV 療效研究中並未達到預防感染的主要終點。我們將停止先天性鉅細胞病毒的研發。但是,我們將繼續在正在進行的 II 期試驗中評估 mRNA-1647 對接受骨髓移植患者的療效。
In rare diseases, I'm happy to announce that we have reached target enrollment of the registrational study for our propionic acidemia or PA program. We also had the opportunity to present data from our ongoing Phase I/II study at the International Congress of Inborn Errors of Metabolism Medical Meeting during the quarter. For methamolonic acidemia, or MMA, we presented interim data from the Phase I/II trial at that same meeting, and we expect our MMA registrational trial to start in 2026. Turning now to our oncology portfolio.
在罕見疾病領域,我很高興地宣布,我們的丙酸血症(PA)計畫註冊研究已達到目標入組人數。本季度,我們還有機會在國際先天性代謝缺陷醫學會議上展示了我們正在進行的 I/II 期研究的數據。對於甲氧氯酸血症(MMA),我們在同一次會議上公佈了 I/II 期試驗的中期數據,我們預計 MMA 註冊試驗將於 2026 年開始。接下來我們來看看我們的腫瘤產品組合。
We continue to make significant progress in advancing our programs. For (inaudible), which is partnered with Merck, we have several late-stage studies underway. Our Phase III trial in adjuvant melanoma is fully enrolled and accruing events towards its interim analysis. Our Phase II adjuvant renal cell carcinoma trial is also fully enrolled. And as we have disclosed previously, we have 2 Phase III studies in non-small cell lung cancer and multiple randomized Phase II studies, including a Phase II study in high-risk muscle-invasive bladder cancer and a Phase II study in high-risk non-muscle invasive bladder cancer, all of which are still enrolling.
我們在推動各項計劃方面持續取得顯著進展。對於(聽不清楚),我們與默克公司合作,目前正在進行幾項後期研究。我們針對黑色素瘤輔助治療的 III 期試驗已完成全部受試者招募,並正在累積事件數據以進行中期分析。我們的 II 期輔助性腎細胞癌試驗也已完成全部受試者招募。正如我們之前所揭露的那樣,我們目前有 2 項針對非小細胞肺癌的 III 期研究和多項隨機 II 期研究,包括一項針對高危險肌肉層浸潤性膀胱癌的 II 期研究和一項針對高危險群非肌肉層浸潤性膀胱癌的 II 期研究,所有這些研究都仍在招募患者。
We've also expanded our (inaudible) program into the metastatic study with a Phase II study in first-line metastatic melanoma and a recently opened Phase II study in first-line metastatic squamous non-smelter cell lung cancer. Both these studies are randomized trials. Neoantigen from neoantigen analysis from our Phase II adjuvant melanoma trial was presented at the Society for Melanoma Research meeting in October.
我們也擴大了(聽不清楚)項目,進行了轉移性研究,包括一線轉移性黑色素瘤的 II 期研究和最近啟動的一線轉移性鱗狀非熔化細胞肺癌的 II 期研究。這兩項研究均為隨機對照試驗。我們在 II 期輔助黑色素瘤試驗中透過新抗原分析得到的新抗原已於 10 月在黑色素瘤研究學會會議上發表。
Now moving to mRNA-4359, which is enrolling a Phase II study in first-line metastatic melanoma and first-line metastatic non-small cell lung cancer patients. The decision to proceed to that phase into those Phase II was based on encouraging Phase Ib data, some of which was presented at the recent ESMO Medical Congress.
現在轉向 mRNA-4359,該藥物正在招募一線轉移性黑色素瘤和一線轉移性非小細胞肺癌患者進行 II 期研究。決定進入第二階段是基於令人鼓舞的第一階段數據,其中一些數據已在最近的 ESMO 醫學大會上公佈。
In early-stage oncology, we are dosing patients in a Phase I trial for our cancer antigen therapy program, mRNA-4106. For our T-cell engager program, mRNA-2808, I'm happy to announce that the first patient was dosed in the Phase I trial during the quarter.
在早期腫瘤學領域,我們正在對癌症抗原療法計畫 mRNA-4106 進行 I 期試驗,並給予患者。我很高興地宣布,我們的 T 細胞銜接器計畫 mRNA-2808 的首位患者已在本季度接受了 I 期試驗的給藥。
Finally, the IND for our cell therapy enhancer, mRNA-4203, is open, and we look forward to enrolling and dosing the first patient in that study. We're pleased by the growth and breadth of our clinical stage oncology pipeline and the continued strong momentum of the multiple Phase III and randomized Phase II trials within our (inaudible) clinical trial program conducted in partnership with Merck.
最後,我們的細胞治療增強劑 mRNA-4203 的 IND 申請已開放,我們期待招募並給該研究中的第一位患者用藥。我們對臨床階段腫瘤產品線的成長和廣度感到滿意,與默克公司合作進行的(聽不清楚)臨床試驗計畫中的多項 III 期和隨機 II 期試驗也持續保持強勁勢頭。
With that, I will hand the call over to Stephane.
接下來,我將把電話交給史蒂芬。
Stephane Bancel - Chief Executive Officer, Director
Stephane Bancel - Chief Executive Officer, Director
Thank you, Stephen and Jamey. Looking at the three value drivers of our business: commercial, pipeline and financial. Commercially, we are seeing the benefit from market share gains of mNEXSPIKE, which we believe will continue in 2026 and beyond. Next year, our commercial business will benefit from the full year contribution from our strategic partnership in Canada, UK and Australia.
謝謝史蒂芬和傑米。我們檢視業務的三大價值驅動因素:商業、通路和財務。從商業角度來看,我們已經看到了 mNEXSPIKE 市場份額成長帶來的好處,我們相信這種成長勢頭將在 2026 年及以後繼續保持。明年,我們的商業業務將受益於我們在加拿大、英國和澳洲的策略夥伴全年的貢獻。
From a pipeline standpoint, we look forward to potential approvals of our combination of flu plus COVID vaccine in Europe. The file is currently being reviewed and in Canada, where we expect to revise soon. In the US, we look forward to refiling further guidance from the FDA.
從研發管線的角度來看,我們期待我們的流感疫苗加新冠疫苗組合在歐洲獲得潛在批准。該文件目前正在加拿大接受審核,我們預計很快就會進行修改。在美國,我們期待向FDA重新提交進一步的指導意見。
Later this year, we filed our seasonal pro vaccine mRNA-1010 for approval in the US, Canada, Australia and the EU. We also expect to see two critical milestones from our (inaudible) program. First, the five-year follow-up data from our Phase II adjuvant melanoma study; and second, the efficacy data from our Phase III adjuvant animal study. We look forward to the Phase II data from our cancer (inaudible), we have to look forward to a Phase III efficacy data from norovirus vaccine and the restriction an efficacy study data for PA program propylitic acidemia in rare disease.
今年晚些時候,我們向美國、加拿大、澳洲和歐盟提交了季節性疫苗 mRNA-1010 的批准申請。我們也期待看到我們的(聽不清楚)計畫取得兩個關鍵里程碑。首先,我們發表了 II 期輔助黑色素瘤研究的五年追蹤數據;其次,我們發表了 III 期輔助動物研究的療效數據。我們期待癌症(聽不清楚)的 II 期數據,我們期待諾羅病毒疫苗的 III 期療效數據,以及 PA 項目丙酸血症在罕見疾病中的限制和療效研究數據。
We have exercised strong financial disciplines so far this year. We have ahead of our initial 2025 cash cost production by $900 million. We will continue to improve our cost structure and drive productivity.
今年以來,我們一直奉行嚴格的財務紀律。我們目前的現金生產成本比 2025 年的初始成本高出 9 億美元。我們將持續優化成本結構,提高生產效率。
For (inaudible) cash balance projection, we have increased our year-end projection to a range from $6.5 billion to $7 billion, up $500 million to $1 billion from our prior guidance of around $6 billion. We know that a higher cash balance to exit 2025 and a much ecostructure when we enter 2025 is the right strategy as we transition from a single pandemic product company to a large, diversified portfolio of commercial products in seasonal vaccines, oncology medicines and rare disease medicines.
對於(聽不清楚)現金餘額預測,我們將年末預測範圍上調至 65 億美元至 70 億美元,比我們之前約 60 億美元的指導值增加了 5 億美元至 10 億美元。我們知道,在 2025 年底擁有更高的現金餘額,並在 2025 年初擁有更完善的生態系統,才是正確的策略,因為我們正在從一家單一的疫情產品公司轉型為一家擁有大型多元化商業產品組合的公司,這些產品包括季節性疫苗、腫瘤藥物和罕見疾病藥物。
In closing, I want to recognize the entire Moderna team for their net less dedication to our mission. For our progress, scientific, clinical, commercial and operational is focused on our mission, delivering the greatest possible impact to people for mRNA medicines.
最後,我要感謝 Moderna 團隊全體成員對我們使命的無私奉獻。為了取得進展,我們在科學、臨床、商業和營運方面都專注於我們的使命,為mRNA藥物帶來盡可能大的影響。
With this, operator, we'll be happy to take questions.
操作員,有了它,我們很樂意回答您的問題。
Operator
Operator
(Operator Instructions) Salveen Richter, Goldman Sachs.
(操作說明)薩爾文·里希特,高盛。
Salveen Richter - Analyst
Salveen Richter - Analyst
Good morning. Thanks for taking my questions. As we look to the expense management on the forward here, can you help us understand what's being deprioritized or change to allow for these changes? And then secondly, in accordance with kind of Roivant and the IP dynamics that are playing out here, can you just frame your strategy here on the Board as we look into 2026? Thank you.
早安.謝謝您回答我的問題。展望未來的費用管理,您能否幫助我們了解哪些項目被降低優先順序或需要做出哪些改變以適應這些變化?其次,根據 Roivant 的現狀以及這裡正在上演的 IP 動態,您能否在展望 2026 年之際,為董事會制定您的策略?謝謝。
James Mock - Chief Financial Officer
James Mock - Chief Financial Officer
Sure. Thanks for the questions. I'll take the first one. So it depends on your reference point in terms of what you talk about from a cost-out perspective over the last few years, as I mentioned, we're down 50% from a cash cost basis. But a more recent in our recent $500 million to $700 million reduction, that split evenly across R&D and cost of sales.
當然。謝謝大家的提問。我選第一個。所以,這取決於你從成本角度來看的參考點。正如我所提到的,過去幾年,我們的現金成本下降了 50%。但最近我們削減了 5 億至 7 億美元的開支,其中研發成本和銷售成本各佔一半。
So cost of sales is purely driving efficiencies, everything that the teams are hard at work and have been hard at work doing. They're just accelerating and getting it done faster. So that's unutilized manufacturing capacity that is all the waste that we saw in materials. They're doing a great job reducing that, driving productivity within the labor force. So that's not really a deprioritized investment.
因此,銷售成本完全取決於效率的提升,而這正是團隊一直以來努力的目標。他們只是加快了速度,更快地完成了任務。所以,我們看到的所有材料浪費都是未經利用的生產能力所造成的。他們在降低失業率、提高勞動生產力方面做得非常出色。所以這其實並不是一項被降級的投資。
On R&D, it's a bit of both. It is -- the execution of our clinical trials has been much more efficient. We've talked in the past about the fact that we were operating for speed. And this time, we are operating for cost as well in efficiency. So a lot of this is just the execution of our trials. But we are making decisions here and there to not continue to advance to Phase II or Phase III or even out of Phase I here and there.
在研發方面,兩者兼具。確實如此——我們的臨床試驗執行效率大大提高。我們過去曾討論過,我們當時追求的是速度。這一次,我們不僅要考慮成本,還要考慮效率。所以,這其中很多都只是我們試驗的執行過程。但是,我們有時會做出一些決定,不再繼續前進到第二階段或第三階段,甚至有些時候不再進入第一階段。
Broadly, we're taking down our just big picture story from the last couple of years. Our large Phase III vaccine trials are really running down and winding down, including CMV recently and flu combination vaccine. And after that, we are moving into oncology, which is a different amount of patients that are under those trials.
總的來說,我們將回顧過去幾年的大局故事。我們的大型 III 期疫苗試驗真的正在接近尾聲,包括最近的 CMV 疫苗和流感聯合疫苗。之後,我們將進入腫瘤學領域,該領域涉及不同數量的患者參與試驗。
So there is some prioritization in there, as we've always said, but a lot of it is also execution. But we still have prioritized our pipeline. So we are excited about the 9 or 10 late-stage programs that we have that Stephen highlighted in his prepared remarks, and we look forward to continuing to take out additional costs, and we do see that coming down over the coming years, and we'll update you more at the Analyst Day.
所以,正如我們一直所說,這裡面確實存在一些優先排序,但很多時候也取決於執行力。但我們仍然優先發展我們的產品線。因此,我們對史蒂芬在準備好的發言稿中重點提到的 9 或 10 個後期項目感到興奮,我們期待繼續削減額外成本,並且我們確實看到未來幾年成本會下降,我們將在分析師日上向您提供更多信息。
Stephane Bancel - Chief Executive Officer, Director
Stephane Bancel - Chief Executive Officer, Director
And good morning, Salveen. On (inaudible), the trial in the US is scheduled for March 9, 2026. We remain confident in the groundbreaking technology with Pioneer, including our lipid-nanoparticle delivery system were vigorously defending the case and responding to new filings outside the US. We believe that our technology does not infringe any valid patents asserted by (inaudible).
早上好,薩爾文。(聽不清楚)美國的審判定於 2026 年 3 月 9 日舉行。我們對 Pioneer 的突破性技術仍然充滿信心,包括我們的脂質奈米顆粒輸送系統,我們正在積極捍衛這一案件,並回應美國境外的新訴訟。我們相信,我們的技術不侵犯任何有效專利。(聽不清楚)
Operator
Operator
Gena Wang, Barclays.
吉娜·王,巴克萊銀行。
Gena Wang - Analyst
Gena Wang - Analyst
Thank you for taking my questions. Maybe two very quick questions. First one is regarding the US COVID revenue, $781 million, that I assume majority of this basically is the inventory build-up delivery to the pharmacists. So maybe how often do you track pharmacies to maintain their inventory? And what are additional color you can share regarding your estimate of the revenue for the remaining of this year?
謝謝您回答我的問題。也許可以問兩個很簡單的問題。首先是關於美國 COVID 收入,7.81 億美元,我估計其中大部分基本上是向藥劑師提供的庫存積累和交付。那麼,你們多久會追蹤一次藥局的庫存情況呢?關於您今年剩餘時間收入的預測,您還能透露哪些資訊?
And then second question is regarding the CMS -- sorry, CMV vaccine. So what is the learning there? Why immunogenicity data did not translate to clinical benefit?
第二個問題是關於 CMS——抱歉,是 CMV 疫苗。那麼,我們能從中學到什麼呢?為什麼免疫原性數據未能轉化為臨床效益?
James Mock - Chief Financial Officer
James Mock - Chief Financial Officer
Okay. So thanks, Gena. Good to hear from you. I'll take the US sales. So ultimately, the end measure is vaccinations in the US that shots and arms. And so in the third quarter, yes, we ship a lot of our product into wholesalers and then they take it down to our pharmacists, whether that's a retail pharmacy or an IDN network, a doctor, a physician's office. And so we track that almost daily.
好的。謝謝你,吉娜。很高興收到你的來信。我負責美國市場的銷售。所以歸根究底,美國的最終措施是接種疫苗,也就是注射和武裝。因此,在第三季度,是的,我們會將大量產品運送給批發商,然後他們再將產品分發給我們的藥劑師,無論是零售藥局還是 IDN 網路、醫生或診所。因此,我們幾乎每天都會追蹤這些數據。
And really, what we put what Stephen shared with you on the screen is that's why we show shots and arms. We believe that's the ultimate measure. And if you look at season to date through October 24, shots and arms are down in the US, 30%. There's a lot of reasons for that, some of which we anticipated.
實際上,我們把史蒂芬分享的內容呈現在螢幕上,這就是我們展示射擊和手臂動作的原因。我們認為這是最終的衡量標準。如果從截至 10 月 24 日的賽季至今來看,美國的注射次數和手臂數量下降了 30%。造成這種情況的原因有很多,其中一些是我們預料到的。
And if I take this back to our guidance, -- when we originally guided at the beginning of the year, we said $1.5 billion in the US sales, $1 billion to $1.5 billion. The $1.5 billion was essentially flat year-over-year for all aspects, whether it's market share, competitive dynamics, vaccination rates, et cetera, excluding a onetime item from the prior year. And the $1 billion, as I said, is down 33%. So we obviously anticipated that the vaccination rate, which is the largest variable here, could go down. And so now we've seen that go down and we've reduced our range. So we said that we believe vaccination rates will now be down 20% to 40%.
如果我回顧一下我們年初的業績預期,我們當時預測美國銷售額將達到 15 億美元,即 10 億至 15 億美元。15 億美元與去年同期基本持平,無論是市場份額、競爭動態、疫苗接種率等等,不包括上年的一次性項目。正如我所說,這10億美元下降了33%。因此,我們顯然預料到疫苗接種率(這是這裡最大的變數)可能會下降。所以現在我們看到這種情況有所下降,我們也縮小了我們的範圍。因此我們預測,疫苗接種率將下降 20% 至 40%。
And we are in the heart of the vaccination season. We're probably half to 2/3 of the way through. So we have good visibility to this. We are measuring shots in arms. We talked about our share as well. And we also look at every single day and every single week is there more pull down? Is it more pull down to the physicians? Is it more pull down to retail -- are there more shipments even in the fourth quarter. So -- and we feel very comfortable with our range now of $1 billion to $1.3 billion, but we do not see vaccination rates in the US getting back to flat, which is the change from the high end, from going from $1.5 billion to $1.3 billion.
現在正值疫苗接種季的關鍵時期。我們大概已經完成一半到三分之二了。所以我們對此有很清晰的了解。我們正在用手臂來衡量射擊次數。我們也談到了我們各自的份額。我們還要查看每一天、每一周,看看是否有更多下滑的情況出現?是否更多地將權力下放給醫生了?零售通路的拉動效應是否更強-即使在第四季度,出貨量是否也更多?所以——我們現在對10億至13億美元的範圍感到非常滿意,但我們不認為美國的疫苗接種率會恢復到平穩水平,這與之前15億至13億美元的上限有所不同。
Stephen Hoge - President
Stephen Hoge - President
Great. And Gena, I'll take the CMV question. So first, we really only have, at this point, the top line data from that trial. And over the coming weeks and months, we will get a tremendous amount of more information, including detailed information on a bunch of other immunogenicity and potentially even correlate production and have the ability to generate hypotheses on what maybe didn't work.
偉大的。吉娜,我來回答關於改變我的觀點(CMV)的問題。所以首先,目前我們只有該試驗的主要數據。在接下來的幾周和幾個月裡,我們將獲得大量更多信息,包括許多其他免疫原性的詳細信息,甚至有可能將生產與免疫原性聯繫起來,並能夠對可能失敗的原因提出假設。
What I can say at this point is, as you know, going into the trial, we and the field had high hopes that a Pentamer neutralizing antibody response, which had not been a part -- a strong (inaudible) response, which had not been a part of previous attentive vaccine was going to be the missing piece for being able to prevent infection with a CMV vaccine. Prevention of infection with the herpes virus or in CMV was an incredibly high bar. It was a difficult bar to go after. But ultimately, the only one we thought that we could test that had a chance at meeting our target product profile for prevention of congenital CMV.
我現在能說的是,正如你們所知,在進行試驗之前,我們和業內人士都寄予厚望,認為五聚體中和抗體反應(以前任何疫苗都沒有這種反應)將成為CMV疫苗預防感染的關鍵所在。預防皰疹病毒或鉅細胞病毒感染是一項極為艱鉅的任務。那是一家很難去的酒吧。但最終,我們認為唯一能夠測試並有可能達到我們預防先天性 CMV 目標產品特性的產品。
So I guess what we can say at this point until we get that additional data is it looks like and Pentamer neutralizing antibodies weren't the missing piece and that it wasn't sufficient by itself to drive a dramatic improvement in the prevention of infection with CMV. Now we'll dig into the data as we get it over the coming months, obviously, look forward to publishing and sharing it at medical conferences. And hopefully, the entire field can learn where vaccine development in CMV might need to go next. But ultimately, Pentamer wasn't enough.
所以,在獲得更多數據之前,我們目前可以這麼說:五聚體中和抗體似乎不是缺失的那一塊,它本身並不足以顯著改善 CMV 感染的預防。接下來幾個月,我們將逐步深入研究所得的數據,顯然,我們期待在醫學會議上發表並分享這些研究成果。希望整個領域都能從中了解鉅細胞病毒疫苗研發的下一步。但最終,五聚體還不夠。
Operator
Operator
Cory Kasimov, Evercore.
Cory Kasimov,Evercore。
Cory Kasimov - Analyst
Cory Kasimov - Analyst
Good morning, guys. Thanks for taking the questions. I shift gears over to the pipeline. I want to ask about your norovirus program. Are you surprised at all by the low case accruals here? Or is this kind of anticipated? And do you believe this offers any sort of reflection on the commercial opportunity or potential demand for the product should it be approved? Thank you.
各位早安。謝謝您回答問題。我把注意力轉移到管道上。我想諮詢一下你們的諾羅病毒防治程序。您對這裡病例數少感到驚訝嗎?還是這是意料之中的事?您認為這是否反映了該產品如果獲得批准後的商業機會或潛在需求?謝謝。
Unidentified Company Representative
Unidentified Company Representative
Thanks for the question, Cory. So predicting epidemiology and norovirus is still an early space. And so we had always designed the study as a potential 2-season study. In fact, we're we'd always expected that it was possibly going to be necessary, that happens in flu vaccines, that has happened in other respiratory vaccines, other vaccines based on case accrual, happened to us here.
謝謝你的提問,科里。因此,流行病學和諾羅病毒的預測仍處於起步階段。因此,我們一直將這項研究設計為可能持續兩個季度的研究。事實上,我們一直都預料到可能會出現這種情況,流感疫苗就是如此,其他呼吸道疫苗也是如此,其他疫苗都是根據病例累積情況而定的,現在這種情況也發生在我們這裡。
I think we believe we're getting better at predicting where that epidemiology will be, where we cite the trials and ultimately being able to recruit cases that are matched to the vaccine come position. And I think we are hopeful that with this additional second season, which was always a possibility that we'll be able to show -- or accrue enough cases to conduct that and ultimately demonstrate the efficacy of the vaccine.
我認為我們相信,我們在預測流行病學走向、引用試驗以及最終招募與疫苗接種時機相匹配的病例方面,正在取得進展。我認為我們有信心,透過這額外的第二季試驗(這始終是一種可能性),我們將能夠展示——或者累積足夠的病例來進行試驗,並最終證明疫苗的有效性。
The impact on commercial target product profile we forward, I would say we don't believe that there's been a change to that. At the end of the day, what matters here is hopefully a highly effective vaccine against preventing norovirus. It is a well-established burden of disease globally. And we do believe that the health economic benefit of prevention of severe to moderate infections with norovirus will be clear, particularly those that are at highest risk, including those that live in long-term care facilities or for other occupational reasons might be at risk. So we still feel strongly about that target product profile and think that the epidemiology challenges of the last season will be addressable with the second season of enrollment.
就我們展望的商業目標產品概況的影響而言,我認為我們並不認為這方面發生了變化。歸根究底,最重要的是希望能夠研發出一種高效率的諾羅病毒疫苗。它已成為全球公認的疾病負擔。我們相信,預防諾羅病毒中度至重度感染的健康經濟效益是顯而易見的,尤其是對於那些風險最高的人群,包括長期照護機構的居民或因其他職業原因可能面臨風險的人群。因此,我們仍然對該目標產品概況充滿信心,並認為上一季的流行病學挑戰將在第二季的招募中得到解決。
Operator
Operator
Luca Issi, RBC
Luca Issi,RBC
Luca Issi - Analyst
Luca Issi - Analyst
Great. Thanks so much for taking my questions. Congrats on the progress.
偉大的。非常感謝您回答我的問題。恭喜你取得進展。
Maybe, Jamey, can you just talk about what gives you confidence that you can reiterate your cash breakeven guide for 2028? I appreciate you're making some fantastic progress in terms of like managing the OpEx and the CapEx, but still the cash cost at the midpoint this year is $4.6 billion. So I think in order to break even in 2028, you really need your top line to reinflect quite materially from here. So can you just talk about that?
Jamey,或許你可以談談是什麼讓你有信心重申你對 2028 年現金損益平衡點的預測?我很欣賞你們在營運支出和資本支出管理方面取得的巨大進步,但今年年中現金成本仍高達 46 億美元。所以我認為,為了在 2028 年實現收支平衡,你的營收真的需要比現在有相當大的提升。所以你能談談這個嗎?
I mean, it looks like COVID is still declining. RSV, maybe it's one and done for now. CMV did not make it. IMP initially, it's going to be just for adjuvant melanoma. So what are the near-term product that you think can really inflect the top line in the foreseeable future?
我的意思是,看起來新冠疫情仍在下降。RSV,也許這次就到此為止了。CMV沒能存活下來。IMP最初將僅用於輔助治療黑色素瘤。那麼,您認為在可預見的未來,哪些近期產品能真正影響營收?
And then maybe second, Stephane, quickly. I think a few media outlets have reported in Moderna is working on potential large deals with pharma. So wondering if you can comment on that. And then maybe bigger picture, what's your latest thinking on (inaudible) these days. Thanks so much.
然後,也許第二個,史蒂芬,快點。我認為有些媒體已經報導過,Moderna正在與製藥公司洽談潛在的大型交易。所以想問您是否可以對此發表一下看法。那麼,從更宏觀的角度來看,你最近對(聽不清楚)有什麼想法?非常感謝。
James Mock - Chief Financial Officer
James Mock - Chief Financial Officer
Thanks, Luca. There's a lot in there. And I -- we recognize it's on everybody's mind, and we're going to lay this out at the Analyst Day, just so you know. So -- but I'll mention a couple of things here.
謝謝你,盧卡。裡面內容很多。而且——我們知道這是每個人都在關心的問題,我們將在分析師日上詳細說明,讓大家知道。所以——但我在這裡要提幾點。
When we say and we all commit to breaking even, it is both a mix to your point of revenue growth and cost reduction. And so on the cost reduction side, as I mentioned earlier, to Salveen's question, we see ample opportunity. And I mentioned that we will update our 2026 and 2027 framework at the Analyst Day, but there's still plenty to do on that front.
當我們說並且我們都致力於實現收支平衡時,這不僅是收入成長的目標,也是成本降低的目標。因此,在降低成本方面,正如我之前提到的,對於 Salveen 的問題,我們看到了充足的機會。我曾提到,我們將在分析師日上更新我們的 2026 年和 2027 年框架,但在這方面仍有許多工作要做。
On the revenue side, we have -- we see a lot through geographic expansion through our strategic partnerships that I mentioned in my prepared remarks, through new product introductions. We'll get them to lay that out in a more fulsome way at Analyst Day, but we remain committed. But yes, it is a mix of both the revenue side growing as well as the cost side reducing, and we still feel confident in our plan.
在收入方面,我們看到了許多成長——透過我在準備好的發言稿中提到的策略合作夥伴關係實現的地域擴張,以及透過新產品的推出。我們會讓他們在分析師日上更詳細地闡述這一點,但我們仍然致力於此。是的,這既包括收入成長,也包括成本降低,我們仍然對我們的計劃充滿信心。
Stephane Bancel - Chief Executive Officer, Director
Stephane Bancel - Chief Executive Officer, Director
Thank you, Jamey. And on the deal side, as we spoke about in several of our last calls, we really want to get products like the latent vaccine like EBV, for example, to patients. As we've said, part of our privatization of our portfolio, we do not want to fund a Phase III by ourselves. And so we are talking to our companies. We are talking to financial sponsors. As you know, we have a partnership with Blackstone that we did on flu, mRNA-1010. So those discussions are ongoing. And when we have something to communicate, we will.
謝謝你,傑米。在交易方面,正如我們在最近幾次電話會議中談到的那樣,我們真的希望將像 EBV 這樣的潛伏疫苗等產品送到患者手中。正如我們所說,作為我們投資組合私有化的一部分,我們不想獨自承擔第三階段的資金。所以我們正在和各公司溝通。我們正在與投資者洽談。如您所知,我們與黑石集團在流感 mRNA-1010 方面建立了合作關係。所以這些討論仍在進行中。如果有任何事情需要溝通,我們會進行的。
Operator
Operator
Tyler Van Buren, TD Cowen.
泰勒·範·布倫,TD·考恩。
Unidentified Participant
Unidentified Participant
Thanks for taking my question. This is Greg on for Tyler. It looks like mNEXSPIKE is already taking the slight majority of your COVID vaccinations over Spikevax. So how do you expect the split between these 2 vaccines to continue to evolve? And I'd also be interested to hear what feedback you're hearing from pharmacists and other clinicians about mNEXSPIKE so far. Thank you.
謝謝您回答我的問題。這是格雷格替泰勒發言。看來 mNEXSPIKE 已經比 Spikevax 佔據了新冠疫苗接種市場的大部分份額。那麼,您認為這兩種疫苗之間的差距將如何繼續演變?我也很想聽聽您目前從藥劑師和其他臨床醫生那裡得到的關於 mNEXSPIKE 的回饋。謝謝。
Stephen Hoge - President
Stephen Hoge - President
Thanks for the questions. So we're obviously really pleased with that launch. It has become our leading product in the overall COVID franchise. And that's been, frankly, exceeded our expectations in a positive way. It really speaks to the profile. We think the clinical data as well as the overall sort of momentum in the market towards higher risk populations. Some of that is a result of changes in recommendation in this country, towards in the United States towards higher risk individuals and those over the age of 65.
謝謝大家的提問。所以,我們對這次發表會非常滿意。它已成為我們整個新冠肺炎產品系列中的領導產品。坦白說,這已經遠遠超出了我們的預期,而且是朝著好的方向發展。這確實很符合個人形象。我們認為臨床數據以及市場整體上向高風險族群發展的趨勢都支持這一觀點。部分原因是由於美國國內的建議發生了變化,更加關注高風險族群和 65 歲以上的人。
We're continuing to build out that medical story, and the data has been shared obviously at ACIP, but in medical meetings. And we hope to continue to build momentum behind the mNEXSPIKE brand as our leading product in the franchise.
我們正在繼續完善這個醫學故事,相關數據顯然已經在 ACIP 和其他醫學會議上分享過了。我們希望繼續鞏固 mNEXSPIKE 品牌作為我們特許經營中領先產品的地位。
Now Spikevax will always have a place. And as you know, Spikevax is the only approved product in pediatrics down to six months to four-year olds. And that is an important population, particularly for those with high risk factors, those with lung disease or those with underlying comorbidities, even in the young population. So we will always expect some portion to be at Spikevax, but over time, we would hope that the older adults and higher risk populations might migrate to mNEXSPIKE. That's consistent with the feedback we've been getting.
如今,Spikevax 將永遠佔有一席之地。如您所知,Spikevax 是唯一獲準用於 6 個月至 4 歲兒童的兒科產品。這是一個重要的群體,特別是對於那些有高危險因子的人、患有肺部疾病或有潛在合併症的人,即使是年輕族群也是如此。因此,我們始終期望有一部分人會選擇 Spikevax,但隨著時間的推移,我們希望老年人和高風險族群能夠遷移到 mNEXSPIKE。這與我們收到的回饋一致。
And in fact, if you look at many of our large customers, both health systems and pharmacies, that is how they are thinking about the products and using them. We'll be working with governments around the world as we move to not launch mNEXSPIKE -- sorry, as we move to launch mNEXSPIKE outside of the US for the next season, and we hope to continue to see growth in that brand as a part of our overall franchise.
事實上,如果你看看我們的許多大客戶,包括醫療系統和藥房,你會發現他們就是這樣看待和使用產品的。我們將與世界各國政府合作,逐步停止在美國以外地區推出 mNEXSPIKE——抱歉,更正為在下一季停止在美國以外地區推出 mNEXSPIKE,我們希望該品牌作為我們整體特許經營的一部分,能夠繼續保持增長勢頭。
But as I said, we will always have both. I don't have specific guidance on the split because at the end of the day, this is a decision made by health care providers and customers about what's the most appropriate choice for their patients.
但正如我所說,我們永遠都會兩者兼得。我沒有關於拆分的具體指導意見,因為歸根結底,這是醫療保健提供者和客戶根據對他們的患者而言最合適的選擇而做出的決定。
Operator
Operator
Jessica Fye, JPMorgan.
潔西卡費伊,摩根大通。
Unidentified Participant
Unidentified Participant
Good morning. Thanks for taking my question. (inaudible) for Jessica. How is the US COVID vaccine, demand tracking disease relative to your projections? And what about the ex-US season? And also, can you orient us around the potential annual revenue contribution tied to the manufacturing sites in the UK, Canada and Australia? Thank you.
早安.謝謝你回答我的問題。 (聽不清楚)代表傑西卡。美國新冠疫苗的需求量與疫情發展相比,與您的預測有何不同?那麼前美國隊賽季的情況如何呢?另外,您能否介紹一下英國、加拿大和澳洲的生產基地每年可能帶來的收入貢獻?謝謝。
Unidentified Company Representative
Unidentified Company Representative
Yes. So yeah, I'll break it down, the US, so US and then the manufacturing contribution. So -- it's track. I think I mentioned this a little bit already. So our revised guidance is $1 billion to $1.3 billion in the US. We anticipate the vaccination rates are -- could be in the range of down 20% to down 40%. And -- that's not too different than what we thought at the outset of the year that it could be flat to down. We definitely incorporated a scenario where vaccination rates going to be down, but we feel good about it. We are mostly we're halfway through the season and feel good about and have confidence in our U.S. range.
是的。是的,我會詳細分析一下,先是美國,然後是美國,最後是製造業的貢獻。所以——這是賽道。我想我之前已經稍微提過這一點了。因此,我們修訂後的預期是美國市場營收為10億至13億美元。我們預計疫苗接種率可能會下降 20% 到 40%。而且——這和我們年初認為的走勢可能持平或下跌並沒有太大區別。我們確實考慮過疫苗接種率下降的情況,但我們對此感到樂觀。我們現在基本上已經完成了賽季的一半,對我們在美國的業務範圍感到滿意和有信心。
Outside the United States, we actually raised the bottom end of our revenue guidance. So we used to be $0.5 billion to $700 billion, now it's $600 million to $700 million. That's due to -- everything is now contracted. A lot of it has been delivered. And as we look to the last couple of months of this year, what's really coming down with the only variables left or delivery timing, whether some of these falls into the first quarter of 2026 or in remains in 4Q '25. And then there are a couple of markets that are predicated upon vaccination rate. So the demand is still tied vaccination rates. So we feel very comfortable with our range outside the United States as well.
在美國以外,我們實際上提高了營收預期下限。以前我們的規模是 5 億到 7,000 億美元,現在是 6 億到 7 億美元。這是因為——現在一切都已簽訂合約。大部分貨物已經交付。展望今年最後幾個月,剩下的唯一變數就是交付時間,其中一些產品是否會在 2026 年第一季交付,或者是否會在 2025 年第四季交付,這些都將成為現實。此外,還有一些市場是建立在疫苗接種率之上的。所以需求仍與疫苗接種率掛鉤。因此,我們對在美國以外的市場也充滿信心。
Then in terms of the strategic partnerships, if you remember in, I think, the second quarter, we said that the deliveries for our UK strategic partnership has already shifted outside the year, which was the reason we dropped the high end from $2.5 billion at that time to $2.2 billion. So we do not expect any revenue inside this year. That will be pure growth in the year 2026.
至於戰略合作夥伴關係,如果你還記得的話,我想是在第二季度,我們說過,我們與英國的戰略合作夥伴關係的交付已經轉移到年外,這也是我們將當時的最高預期從 25 億美元下調至 22 億美元的原因。因此,我們預計今年不會有任何收入。2026年將實現純粹的成長。
I mentioned in my prepared remarks that half of our international revenue was in Canada in the third quarter. So Canada is up and running. We believe Australia will be up and running from a revenue perspective, that is in the fourth quarter, and then the UK in the first quarter of next year. So we feel good heading into next year that we should be able to see some revenue growth from our strategic partnerships.
我在事先準備好的演講稿中提到,第三季我們國際收入的一半來自加拿大。所以加拿大已經恢復正常運作了。我們相信,從收入角度來看,澳洲將在第四季度恢復正常運營,而英國將在明年第一季恢復正常運作。因此,我們對明年充滿信心,相信能夠從策略夥伴關係中獲得一些收入成長。
Operator
Operator
Geoffrey Meacham, Citigroup.
傑弗瑞‧米查姆,花旗集團。
Geoffrey Meacham - Analyst
Geoffrey Meacham - Analyst
Hey, guys. Thanks so much for the question. I have two for you. So the first one on the cost reduction and just looking at the 2028 breakeven target, I was curious if your pipeline evaluation process has evolved, just to look at maximizing ROI on your R&D investments.
嘿,夥計們。非常感謝你的提問。我這裡有兩個給你。首先,關於降低成本,以及著眼於 2028 年的損益平衡目標,我很好奇你們的研發管線評估流程是否有所改進,以便最大限度地提高研發投資報酬率。
And then on the rare disease platform, what's the capacity in this TA to add more programs? It does seem like it could be quicker to get the proof-of-concept data, but I just maybe wanted to compare that to oncology and how you guys are thinking about it. Thank you.
那麼,在罕見疾病平台上,該技術援助部門是否有能力增加更多項目?看起來獲取概念驗證數據的速度可能會更快,但我只是想把它和腫瘤學進行比較,看看你們是怎麼考慮的。謝謝。
Stephen Hoge - President
Stephen Hoge - President
Thanks for both those questions. So first on R&D, I think it was a couple of years ago and reiterated last year that we said as far as large Phase III programs in our infectious disease pipeline, that we would defer further Phase III investments until we crossed breakeven -- cash breakeven in 2028. And then as a result of that, there would be this substantial downshifting in our R&D expenditures over last year and this year and the next year ahead as the large Phase IIIs for flu, (inaudible) COVID, for CMV and even norovirus runoff. And so we've maintained that position all the way through how we've been constructing our pipeline, which I would say is not necessarily ROI maximizing. It is cash and investment optimizing.
謝謝您提出的這兩個問題。首先說說研發方面,我想大概是幾年前,去年我們重申過,對於傳染病研發管線中的大型 III 期項目,我們將推遲進一步的 III 期投資,直到我們實現盈虧平衡——即 2028 年實現現金盈虧平衡。因此,與去年、今年以及未來一年相比,我們的研發支出將大幅下降,因為針對流感、(聽不清楚)COVID、CMV 甚至諾羅病毒的大型 III 期臨床試驗計畫將停止。因此,我們在建立產品線的過程中一直堅持這一立場,但我認為這並不一定能實現投資回報率最大化。它能優化現金流和投資。
We do believe we have several compelling Phase II programs. EBV is one example of a vaccine against (inaudible) and perhaps multiple sclerosis, but one that we are not moving forward with in terms of investment. I believe that ROI is attractive and positive we do, but we will wait to make investments until we've shown we can break even based on the current products. And so that's the way our portfolio has been evolving from a construction perspective.
我們相信我們有幾個很有前景的二期臨床試驗項目。EBV 是針對(聽不清楚)和或許多發性硬化症的疫苗的一個例子,但我們不會在投資方面推進這種疫苗的研發。我相信投資回報率很有吸引力,而且是正面的,但我們會等到證明我們能夠根據現有產品實現收支平衡後才會進行投資。因此,從建築角度來看,我們的投資組合就是這樣演變的。
Now there are instances and for instance, in our oncology space, where we do see an opportunity to make cash investments within our prior guidance, whether that's with the Intisar in program or with 435 that we think are -- have a very attractive ROI and again, can fit within our breakeven guidance for '28. And so those are instances of where we will continue to move forward.
現在,例如在我們的腫瘤領域,我們看到了一些機會,可以在我們之前的指導範圍內進行現金投資,無論是 Intisar 項目還是我們認為具有非常有吸引力的投資回報率的 435,並且同樣可以符合我們 2028 年的盈虧平衡指導。因此,在這些方面,我們將繼續前進。
And maybe that's a natural segue to the last part of your question, which is that is also true, to some extent, in the rare disease space. We have the two programs, PA and MMA, that are moving towards or in the case of PA fully enrolled in their potential registrational studies. And it is a platform where we do believe we can do much more.
也許這自然而然地引出了你問題的最後一部分,那就是,在某種程度上,這在罕見疾病領域也是成立的。我們有 PA 和 MMA 兩個項目,它們正在朝著註冊研究的方向發展,或者 PA 項目已經完全註冊。我們相信,在這個平台上,我們可以做得更多。
There is a very large number of diseases for which we think the technology can work. But again, we want to demonstrate discipline. And so we are not prioritizing making further investments in the rare disease space. until we have PA and MMA through those registrational studies and ideally until we also achieve our breakeven targets for '28. It is a lower cash investment to move those programs forward.
我們認為這項技術可以用於治療多種疾病。但我們再次強調,我們要展現紀律。因此,在PA和MMA的註冊研究取得進展之前,並且理想情況下,在我們實現2028年的盈虧平衡目標之前,我們不會優先考慮在罕見疾病領域進行進一步投資。推進這些項目所需的現金投入較少。
And so as you alluded to, it might be a place that naturally as we get more comfortable over the next year or two that we start moving perhaps a third or a fourth program through, but that will have to be balanced against further investments in oncology like the (inaudible) programs or potentially the re-initiation of pivotal investments in our infectious disease portfolio. And at this point, we'll make those decisions in the future and haven't got a strategic view one way or the other right now.
正如您所提到的,隨著我們在未來一兩年內逐漸適應,我們可能會開始推進第三個或第四個項目,但這必須與進一步投資腫瘤學(如(聽不清楚)項目)或重新啟動傳染病組合的關鍵投資相平衡。目前,我們將在未來做出這些決定,現在還沒有明確的策略方向。
Operator
Operator
Courtney Breen, Bernstein.
Courtney Breen,Bernstein。
Courtney Breen - Equity Analyst
Courtney Breen - Equity Analyst
Hey, guys. Thanks so much for taking my questions. Just wanted to probe a little bit more on the R&D cut. Perhaps kind of and contrasted Salveen's question, perhaps a little bit more forward-looking. As you think about kind of the efficiencies that you've garnered and the new approach, are there more cuts that you can make going forward to that R&D plan? Or would that require actually stopping of programs or changing kind of your prioritized list of assets that you have in the pipe? Thank you so much.
嘿,夥計們。非常感謝您回答我的問題。想再深入了解研發經費削減的情況。或許與薩爾文的問題有些不同,或許更具前瞻性。考慮到已經取得的效率提升和新方法,在推動研發計畫的過程中,是否還有進一步削減成本的空間?或者,這是否需要實際停止某些項目,或改變你正在進行的項目優先事項清單?太感謝了。
Stephen Hoge - President
Stephen Hoge - President
Thank you for the question. So we do expect further reductions in costs. We've previously communicated how we were moving towards breakeven. And so today's cash costs for 2025, while they are better than our guidance, they are not done. And we expect further reductions in our GAAP cost for R&D over the coming year and two purely based on the sunsetting of our existing prioritized investments.
謝謝你的提問。因此,我們預計成本會進一步降低。我們之前已經說明過我們如何朝著損益平衡點邁進。因此,儘管目前公佈的 2025 年現金成本比我們之前的預期要好,但還沒有最終確定。我們預計,未來一兩年內,由於現有優先投資項目的逐步終止,我們的 GAAP 研發成本將進一步降低。
And so we believe that those reductions will happen without further stops. And we will continue to do investment in the early-stage space as well, which as you know, is a less cash-intensive, capital-intensive area. So at this point, we believe we can continue to drive efficiencies and further cost reductions in our R&D investment in the coming years simply by completing the work that we had started several years ago in our infection disease vaccines portfolio.
因此我們相信,這些減產措施將在不會再有阻礙的情況下實現。我們將繼續投資早期階段領域,如您所知,這是一個現金密集度較低、資本密集度較低的領域。因此,我們相信,在未來幾年裡,只要完成我們幾年前在傳染病疫苗組合方面開始的工作,我們就可以繼續提高研發投資的效率並進一步降低成本。
Operator
Operator
Myles Minter, William Blair.
邁爾斯·明特,威廉·布萊爾。
Unidentified Participant
Unidentified Participant
This is John on for Myles. Thanks so much for taking my question. So maybe a follow-up to an earlier question on the CMV program. I know that you're still going through the data, but I was wondering if you could speak to any read-through from the CMV trial missing to any of your other latent vaccine studies or if you view the CMV miss as an isolated event?
這是約翰替邁爾斯報道。非常感謝您回答我的問題。所以,這或許是對先前關於 CMV 計畫的問題的後續提問。我知道您仍在分析數據,但我很想知道,您是否可以談談 CMV 試驗的結果是否對您其他任何潛伏疫苗研究有所影響,或者您是否認為 CMV 試驗的漏報是一個孤立事件?
Stephen Hoge - President
Stephen Hoge - President
Thanks for the question. So CMV was unique in our pipeline in that it is the only pivotal study, a Phase III study that we were running against a latent virus and the only one that was going after a prevention of infection. So we do believe that prevention of infection was unfortunately the only way to try and demonstrate a potential for the vaccine against congenital CMV, but it was by far the highest bar.
謝謝你的提問。因此,CMV 在我們研發管線中是獨一無二的,因為它是唯一一項關鍵性研究,一項針對潛伏病毒的 III 期研究,也是唯一一項旨在預防感染的研究。因此,我們認為,不幸的是,預防感染是嘗試證明疫苗對先天性鉅細胞病毒有潛力的唯一方法,但這無疑是最高的門檻。
Vaccines generally don't prevent infections, they prevent diseases from the viruses. And even in the case of CMV, we still believe that there's an opportunity for mRNA-1647 to have an impact in patients undergoing bone marrow transplant, where they are already infected, but they see a reactivation of their CMV that can have serious potential morbidity and mortality. And for that reason, we think there's an opportunity for a vaccine to help control that reactivation even a vaccine against CMV.
疫苗通常不能預防感染,只能預防由病毒引起的疾病。即使對於 CMV 而言,我們仍然相信 mRNA-1647 有機會對接受骨髓移植的患者產生影響,這些患者已經感染了 CMV,但他們的 CMV 可能會再次激活,從而導致嚴重的潛在發病率和死亡率。因此,我們認為有機會研發出一種疫苗來幫助控制這種病毒的再次激活,即使是針對鉅細胞病毒的疫苗。
So I guess I would say we don't have other programs in our late stage or prioritized pipeline that have a similar read-through or read-through from the CMV results because we are not trying to prevent infection with any of them. We're trying to prevent diseases. And even in the case of CMV, we see a potential opportunity in an indication like bone marrow transplant, CMV reactivation, where, again, target product profile is going against prevention of a disease prevention of infection.
所以我想說,在我們後期或優先研發的專案中,沒有其他專案會像 CMV 結果那樣進行類似的解讀或解讀,因為我們並沒有試圖預防任何感染。我們正在努力預防疾病。即使是 CMV,我們也看到了骨髓移植、CMV 再活化等適應症的潛在機會,在這些適應症中,目標產品的特性再次與預防疾病、預防感染的目標背道而馳。
Operator
Operator
(Operator Instructions)
(操作說明)
I'm not showing any further questions at this time. I'd like to turn the call back over to Stephane for any further remarks.
我目前不再提出其他問題。我想把電話轉回給史蒂芬,讓他再補充一些內容。
Stephane Bancel - Chief Executive Officer, Director
Stephane Bancel - Chief Executive Officer, Director
Well, thank you, everybody, for joining today. We look forward to talking to many of you in the coming days and weeks. And we look forward to seeing many of you here on campus on November 20 for Investor Day. Have a great day. Thank you.
謝謝大家今天到場。我們期待在接下來的幾天和幾週內與你們中的許多人進行交流。我們期待在11月20日投資者日當天在校園裡見到各位。祝你有美好的一天。謝謝。
Operator
Operator
Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.
女士們、先生們,今天的演講到此結束。感謝您的參與。現在您可以斷開連接了,祝您度過美好的一天。