雷傑納榮製藥 (REGN) 2025 Q3 法說會逐字稿

Welcome to the Regeneron Pharmaceuticals' third-quarter 2025 earnings conference call. My name is Shannon, and I'll be your operator for today's call. (Operator Instructions) Please note that this conference is being recorded.

歡迎參加 Regeneron Pharmaceuticals 2025 年第三季財報電話會議。我叫香農，我將擔任您今天通話的接線生。（操作員說明）請注意，本次會議正在錄音。

I will now turn the call over to Ryan Crowe, Senior Vice President of Investor Relations. You may begin.

現在我將把電話交給投資者關係高級副總裁瑞安·克羅。你可以開始了。

Thank you, Shannon. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our third-quarter 2025 earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes.

謝謝你，香農。全世界的聽眾朋友們，早安、下午好、晚上好。感謝您對 Regeneron 的關注，歡迎參加我們 2025 年第三季財報電話會議。本次電話會議的錄音和文字記錄將在會議結束後不久發佈在 Regeneron 投資者關係網站上。

Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer; Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer; Marion McCourt, Executive and Vice President of Commercial; and Chris Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q&A.

今天與我一起參加電話會議的有：董事會聯席主席、聯合創始人、總裁兼首席執行官 Leonard Schleifer 博士；董事會聯席主席、聯合創始人、總裁兼首席科學官 George Yancopoulos 博士；商業執行副總裁 Marion McCourt；以及執行副總裁兼首席財務官 Chris Fenimore。在我們發言完畢後，剩餘時間將用於問答環節。

I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include but are not limited to those related to Regeneron and its products in business; financial forecast and guidance; development programs and related anticipated milestones; collaborations, finances, regulatory matters, payer coverage and reimbursement, intellectual property, pending litigation and other proceedings; and competition. Each forward-looking statement is subject to risk and uncertainties that could cause actual results and events that differ materially from those projected in that statement.

我想提醒各位，今天電話會議上發表的言論可能包含 Regeneron 的前瞻性陳述。此類聲明可能包括但不限於與 Regeneron 及其業務產品相關的聲明；財務預測和指導；開發計劃及相關預期里程碑；合作、財務、監管事項、支付方覆蓋範圍和報銷、知識產權、未決訴訟和其他程序；以及競爭。每項前瞻性聲明都存在風險和不確定性，可能導致實際結果和事件與該聲明中預測的結果和事件有重大差異。

A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2025, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

有關這些及其他重大風險的更完整描述，請參閱 Regeneron 向美國證券交易委員會提交的文件，包括其截至 2025 年 9 月 30 日的季度 10-Q 表格，該表格已於今天上午提交給美國證券交易委員會。Regeneron不承擔任何更新任何前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。

In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures when a reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be found on the Investor Relations website. Once our call concludes, the IR team will be available to answer any further questions.

此外，請注意，今天的電話會議將討論GAAP和非GAAP財務指標。有關我們使用非公認會計準則財務指標的信息，以及這些指標與公認會計準則的調節表，請參閱我們的季度業績新聞稿和公司演示文稿，這兩份文件均可在投資者關係網站上找到。通話結束後，投資人關係團隊將隨時解答您的任何問題。

With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len?

接下來，我將把電話交給我們的總裁兼執行長倫納德‧施萊弗博士。倫？

Thanks, Ryan. Thanks to everyone for joining today's call. For my remarks today, I will summarize our third quarter top line performance, provide an update on EYLEA HD regulatory matters, briefly discuss our recent pipeline progress, and close with some comments regarding our discussions with the United States government to lower drug costs for American patients while preserving innovation.

謝謝你，瑞恩。感謝各位參加今天的電話會議。今天，我將總結我們第三季度的營收表現，介紹 EYLEA HD 監管事宜的最新進展，簡要討論我們最近的研發管線進展，最後就我們與美國政府就降低美國患者藥品成本、同時保持創新方面的討論發表一些看法。

I'll then hand the call over to George, who will provide more details on our pipeline progress. From there, Marion will review our commercial performance. And finally, Chris will detail our financial results and guidance.

然後我會把電話轉給喬治，他會提供更多關於我們管道進展的詳細資訊。之後，瑪莉安將評估我們的商業業績。最後，克里斯將詳細介紹我們的財務表現和業績展望。

Regeneron delivered a solid third quarter driven by double-digit net sales growth for three of our leading products. Compared to the third quarter of last year, worldwide net product sales for Dupixent increased by 26% and Libtayo by 24% at constant exchange rates, while EYLEA HD in the United States grew by 10%.

再生元公司第三季業績穩健，主要得益於旗下三款領先產品淨銷售額的兩位數成長。與去年第三季相比，以固定匯率計算，Dupixent 的全球淨產品銷售額成長了 26%，Libtayo 成長了 24%，而 EYLEA HD 在美國成長了 10%。

Regeneron had Dupixent global net sales for the third quarter with $4.9 billion as recorded by Sanofi with strong growth continuing across approved indications in geographic regions. In the United States, Dupixent net product sales grew 28% compared to the third quarter of last year while maintaining its leadership position in both new to brand prescription share and total prescription share across all indications approved prior to this year.

根據賽諾菲統計，Regeneron公司旗下Dupixent第三季全球淨銷售額達49億美元，在各地區已獲批准的適應症中均維持強勁成長。在美國，Dupixent 的淨產品銷售額比去年第三季度增長了 28%，同時保持了其在新品牌處方份額和今年之前獲批的所有適應症的總處方份額方面的領先地位。

Dupixent is now approved in the United States to treat eight distinct diseases driven by underlying Type 2 inflammation, including diseases of the skin, gut, and respiratory system, spanning age groups from infants to the elderly, and with more than 1.3 million patients globally being actively treated. Dupixent is one of the most widely used biologic medicines. Dupixent's approved indications could potentially address more than 4 million patients in the United States alone, positioning it to remain a strong growth driver over the near, medium, and long-term.

Dupixent 目前已在美國獲準用於治療八種由 2 型發炎引起的不同疾病，包括皮膚、腸道和呼吸系統疾病，涵蓋從嬰兒到老年人的各個年齡段，全球有超過 130 萬名患者正在接受積極治療。度普利森是應用最廣泛的生物製劑之一。Dupixent 核准的適應症僅在美國就可能惠及超過 400 萬名患者，使其在近期、中期和長期內保持強勁的成長動能。

Global Libtayo net product sales were $365 million, up 24% on a constant currency basis compared to the third quarter of last year. In the US, net product sales grew 12% while Libtayo continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers while building share in lung cancer.

Libtayo 全球淨產品銷售額為 3.65 億美元，以固定匯率計算比去年第三季成長 24%。在美國，淨產品銷售額成長了 12%，Libtayo 繼續保持著晚期非黑色素瘤皮膚癌免疫療法的市場領先地位，同時在肺癌領域也取得了市場份額的成長。

Earlier this month, the FDA approved Libtayo in high-risk adjuvant cutaneous squamous cell carcinoma, making Libtayo the first and only PD-1 antibody indicated for this setting. While it only has been a few weeks since approval, our launch is already off to a great start, and we look forward to treating the up to 10,000 addressable patients in the United States who could benefit from this medicine.

本月初，FDA 批准 Libtayo 用於高風險輔助性皮膚鱗狀細胞癌的治療，使 Libtayo 成為第一個也是唯一一個獲準用於此治療的 PD-1 抗體。雖然距離獲批只有幾週時間，但我們的上市已經取得了良好的開端，我們期待為美國多達 10,000 名可能受益於這種藥物的患者提供治療。

Moving to EYLEA and EYLEA HD. Affordability issues continue to dampen branded anti-VEGF category growth. As announced in June, we initiated a matching program for up to $200 million in contributions to the Good Days Retinal vascular and Neovascular Disease Fund. But I am disappointed to report that the matching of third quarter was under $1 million due to the lack of donations from other potential contributors. We remain committed to matching future donations to this fund through the end of the year.

遷移至 EYLEA 和 EYLEA HD。價格因素持續抑製品牌抗 VEGF 藥物類別的成長。正如我們在 6 月宣布的那樣，我們啟動了一項配捐計劃，為「美好時光視網膜血管和新生血管疾病基金」籌集高達 2 億美元的捐款。但令人失望的是，由於其他潛在捐款者的捐款不足，第三季的配額不到 100 萬美元。我們將繼續承諾，在今年底前，對該基金的未來捐款進行等額配捐。

Despite affordability headwinds, EYLEA HD had a strong performance in the third quarter, with US net product sales reaching $431 million, an all-time high, driven by robust physician unit demand growth, partially offset by a lower net price. We continue to believe that future product enhancements, such as a four-week dosing interval, the inclusion of macular edema filing retinal vein occlusion or RVO, and a pre-filled syringe administration are needed to fully unlock EYLEA HD commercial potential.

儘管面臨價格方面的不利因素，EYLEA HD 在第三季度表現強勁，美國淨產品銷售額達到 4.31 億美元，創歷史新高，這主要得益於醫生單位需求的強勁增長，但部分被較低的淨價格所抵消。我們仍然認為，未來的產品改進，例如四周給藥間隔、納入黃斑水腫填充視網膜靜脈阻塞或 RVO 以及預充式註射器給藥，對於充分釋放 EYLEA HD 的商業潛力是必要的。

Earlier this month, we were notified by Catalent Indiana LLC, an affiliate of Novo Nordisk, that the FDA classified their facility as official action indicated or OAI. And to date, the issues identified during the July 2025 inspection have not been completely resolved. On that basis, the FDA issued a complete response letter yesterday for the pre-filled syringe supplemental BLA with the sole of provability issue relating to unresolved inspection findings at Catalent.

本月初，諾和諾德旗下子公司 Catalent Indiana LLC 通知我們，FDA 已將其工廠列為官方行動指示 (OAI)。截至目前，2025 年 7 月檢查中發現的問題尚未完全解決。基於此，FDA昨天就預灌封注射器補充BLA發布了一封完整的回覆函，其中唯一涉及Catalent公司未解決的檢查結果的可證明性問題。

We continue to execute on our previously announced plan to submit an application to add an alternate pre-filled syringe by January 2026 which would trigger a four-month FDA review.

我們將繼續執行先前宣布的計劃，在 2026 年 1 月之前提交申請，增加一種替代的預填充注射器，這將觸發 FDA 為期四個月的審查。

We have also been diligently working with an alternate vial filler and have already submitted an application to include them in the EYLEA HD BLA with a PDUFA date in late December. This would provide an additional opportunity for the FDA to approve the sBLA for every-four-week dosing in RVO given we believe there are no other outstanding review issues for this application.

我們也一直在努力與另一家小瓶灌裝廠合作，並已提交申請，將其納入 EYLEA HD BLA，PDUFA 日期預計在 12 月底。這將為 FDA 批准每四週一次的 RVO 給藥方案的 sBLA 提供額外的機會，因為我們認為該申請沒有其他未決的審查問題。

Moving briefly to our pipeline which George will soon discuss in more detail. We continue to make significant investments in R&D that have yielded notable progress across several key programs. In just the past three months, we have announced positive Phase 3 or registration-enabling data for six distinct programs spanning immunology, neurology, allergy, and rare diseases.

接下來簡單介紹一下我們的管道系統，喬治稍後會詳細討論。我們持續加大研發投入，並在多個關鍵專案中取得了顯著進展。在過去的三個月裡，我們公佈了六個不同項目的積極 3 期臨床試驗或註冊支持數據，這些項目涵蓋免疫學、神經病學、過敏症和罕見疾病。

Over the next several months, we look forward to rapidly expanding pivotal programs in hematology, oncology, thrombosis, obesity, and other metabolic diseases, as well as allergies, all of which we believe represent an impressive next wave of innovative medicines discovered or developed by Regeneron.

在接下來的幾個月裡，我們期待著迅速擴展血液學、腫瘤學、血栓形成、肥胖症和其他代謝性疾病以及過敏症等關鍵項目，我們相信所有這些都代表了再生元發現或開發的令人矚目的下一波創新藥物。

Finally, I'd like to take a moment to address our ongoing progress toward reaching an agreement with the US government to help lower the cost of medicines for American patients. We are having constructive discussions with the administration, and I'm pleased to share that our priorities are closely aligned.

最後，我想花一點時間談談我們目前在與美國政府達成協議以幫助降低美國患者藥品成本方面的進展。我們正在與政府進行建設性討論，我很高興地告訴大家，我們的工作重點高度一致。

Both Regeneron and the administration are deeply committed to ensuring that American patients have timely and affordable access to ground-breaking medical breakthroughs. We likewise share the goal of Preserving the United States' position as a global leader in biotech innovation and manufacturing.

再生元公司和政府都堅定致力於確保美國患者能夠及時、負擔得起地獲得突破性的醫學成果。我們同樣致力於維護美國在全球生物技術創新和製造領域的領導地位。

For more than a decade, George and I have argued that foreign governments have benefited from American innovation without sharing the burden of its cost. We are hopeful the efforts of this administration can level the playing field and convince high GDP nations to contribute their fair share, rather than relying on the United States to shoulder the vast majority of this responsibility.

十多年來，喬治和我一直認為，外國政府從美國的創新中獲益，卻沒有分擔其成本。我們希望本屆政府的努力能創造公平的競爭環境，並說服高GDP國家貢獻應有的份額，而不是依賴美國承擔絕大部分責任。

By addressing this imbalance, we can ensure a more equitable global system that supports continued advancements in medicine while improving affordability for US patients.

透過解決這種不平衡，我們可以確保建立一個更公平的全球體系，支持醫學的持續進步，同時提高美國病患的醫療負擔能力。

Furthermore, we agreed that investing in US manufacturing is not only vital for creating jobs and strengthening our economy, but for safeguarding national security. In fact, in testimony before Congress in 2014, Regeneron highlighted the importance of prioritizing biotech manufacturing and innovation in the United States.

此外，我們一致認為，投資美國製造業不僅對創造就業機會和增強經濟實力至關重要，而且對維護國家安全也至關重要。事實上，在 2014 年向國會作證時，再生元公司強調了優先發展美國生物技術製造和創新的重要性。

Regeneron has already made significant commitments in this area, including our plans to invest over $7 billion in infrastructure and manufacturing facilities in New York and North Carolina over the coming years.

再生元公司已在該領域做出了重大承諾，包括計劃在未來幾年內向紐約州和北卡羅來納州的基礎設施和製造設施投資超過 70 億美元。

We remain optimistic about finding common ground with the administration that strikes the right balance between achieving our shared priorities while advancing Regeneron's mission of harnessing the power of science to deliver life-changing medicine to patients.

我們仍然樂觀地認為，能夠與政府找到共同點，在實現我們共同的優先事項的同時，推進 Regeneron 利用科學的力量為患者提供改變生命的藥物的使命，從而取得適當的平衡。

In closing, Regeneron's business continues to perform well with impressive commercial execution, driving strong financial results in the third quarter. Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities. The commercial team remains focused on maximizing growth drivers from our inline brands, while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long-term value to shareholders.

綜上所述，Regeneron 的業務持續表現良好，商業執行力強，在第三季取得了強勁的財務表現。我們的研發管線有望帶來科學突破，這些突破有可能幫助治療數百萬患者，並轉化為有意義的商業機會。商業團隊將繼續專注於最大限度地發揮現有品牌的成長動力，同時成功推出新產品和適應症。最後，我們將繼續審慎地運用資本，以期為股東創造長期價值。

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

接下來，我將把電話交給喬治。

Thank you, Len. Over the last few months, as Len just mentioned, we have delivered multiple important data readouts showcasing the strength of our robust pipeline and the potential to drive future growth with positive pivotal data for Dupixent for our C5 program, our cat and birch alergy programs, as well as in our rare disease programs. I will also update progress in oncology, anticoagulation, and other programs.

謝謝你，Len。正如 Len 剛才提到的，在過去的幾個月裡，我們發布了多項重要數據，展示了我們強大的研發管線的實力，以及透過 Dupixent 在我們 C5 專案、貓和樺樹過敏專案以及罕見疾病專案中的積極關鍵數據推動未來成長的潛力。我也會報告腫瘤學、抗凝血治療和其他計畫的進展。

Starting with immunology and inflammation. Dupixent continues to deliver remarkable outcomes in addressing indications driven by Type 2 inflammation, potentially adding to its existing approvals for eight diseases in the United States. We're anticipating the FDA's acceptance of our submission for allergic fungal rhinosinusitis or AFRS in patients age 6 years and older based on positive data that we plan to present shortly. This represents yet another potential opportunity for expanding Dupixent's label.

從免疫學和發炎入手。Dupixent 在治療 2 型發炎引起的疾病方面持續取得顯著療效，有望進一步擴大其在美國已獲批准的八種疾病的適應症。我們預計，根據我們計劃很快公佈的積極數據，FDA 將接受我們針對 6 歲及以上患者過敏性真菌性鼻竇炎 (AFRS) 的申請。這代表Dupixent品牌拓展的另一個潛在機會。

Moving to our IL-33 antibody, itepekimab, which was studied in COPD for which it met its primary endpoint in one of two replicant Phase 3 trials, we and Sanofi are contemplating another Phase 3 trial for itepekimab in COPD, pending feedback from regulators. itepekimab development is also advancing other respiratory diseases, most notably our ongoing Phase 3 studies in chronic rhinosinusitis with nasal polyps, where our genetic evidence is compelling.

接下來談談我們的IL-33抗體itepekimab。該抗體已在慢性阻塞性肺病（COPD）的研究中開展，並在兩項重複性3期臨床試驗中的一項中達到了主要終點。目前，我們和賽諾菲正在考慮進行另一項itepekimab治療COPD的3期臨床試驗，目前正在等待監管機構的回饋。 itepekimab的研發也正在推進其他呼吸系統疾病的治療，其中最值得一提的是我們正在進行的治療慢性鼻竇炎伴鼻息肉的3期臨床試驗，該試驗的基因證據令人信服。

Moving to our innovative and multi-pronged allergy programs. As previously announced, our Phase 3 studies of our antibodies for cat allergy and for birch allergy have yielded statistically significant and clinically meaningful outcomes on primary and key secondary endpoints. These results represent the first proof of principle that targeting allergens with highly specific monoclonal antibody cocktails can achieve improvements in both ocular itch and redness.

接下來介紹我們創新且多管齊下的過敏症防治方案。正如先前宣布的那樣，我們針對貓過敏和樺樹過敏的抗體的 3 期研究在主要終點和關鍵次要終點方面取得了具有統計意義和臨床意義的結果。這些結果首次證明了使用高度特異性的單株抗體混合物來靶向過敏原可以改善眼部搔癢和發紅的原理。

Importantly, in prior clinical trials, our cat and birch allergy approaches have delivered impressive and durable therapeutic benefits across nasal, respiratory, and skin allergy symptoms. In the coming months, we plan to present these results at an upcoming medical meeting and initiate confirmatory Phase 3 studies for these programs. In the US alone, these therapies could help approximately 1.6 million people suffering from severe cat allergies in the approximately 1.4 million people suffering from severe birch allergies.

重要的是，在先前的臨床試驗中，我們的貓和樺樹過敏療法在鼻、呼吸道和皮膚過敏症狀方面取得了顯著且持久的治療效果。在接下來的幾個月裡，我們計劃在即將舉行的醫學會議上公佈這些結果，並啟動這些計畫的驗證性 3 期研究。光是在美國，這些療法就能幫助大約 160 萬患有嚴重貓過敏症的人，以及大約 140 萬患有嚴重樺樹過敏症的人。

Regarding our innovative severe food allergy program, enrollment and dosing are progressing well in our small proof-of-concept trial combining linvoseltamab and Dupixent. The first three patients have responded remarkably with greater than 90% rapid reductions in the allergy-causing immunoglobulin E levels following a short course of linvoseltamab treatment which are then maintained and continued to decrease with ongoing Dupixent maintenance. Full enrollment of this small initial study is still expected over the next few months.

關於我們創新的嚴重食物過敏治療方案，在將 linvoseltamab 和 Dupixent 結合使用的小型概念驗證試驗中，受試者招募和給藥進展順利。前三名患者在接受 linvoseltamab 短期治療後，過敏性免疫球蛋白 E 水平迅速下降超過 90%，之後透過持續的 Dupixent 維持治療，該水平得以維持並繼續下降，療效顯著。預計這項小型初步研究的全部受試者將在未來幾個月內入組。

Based on insights gained from the programs so far, we are advancing the development of next-generation agents designed to specifically and safely deplete allergy-causing plasma cells, the first of which is expected to enter clinical trial next year, alongside several other promising novel candidates in immunology and inflammation.

根據迄今為止從這些項目中獲得的見解，我們正在推進下一代藥物的開發，這些藥物旨在特異性且安全地清除引起過敏的漿細胞，其中第一種藥物預計將於明年進入臨床試驗，同時還有幾種其他有前途的免疫學和炎症領域的新候選藥物。

Moving on to oncology and starting with Libtayo, which was recently FDA approved as the first and only immunotherapy for adjuvant treatment of high-risk cutaneous squamous cell carcinoma following surgery and radiation based on the only successful clinical trial in this setting, the C-POST trial data that showed a notable 68% reduction in risk of disease recurrence or death. This approval expands and extends Libtayo's leading position in non-melanoma skin cancers.

接下來談談腫瘤學，首先是 Libtayo，它最近獲得了 FDA 批准，成為目前唯一一種用於手術和放療後高風險皮膚鱗狀細胞癌輔助治療的免疫療法。該療法的批准是基於該領域唯一成功的臨床試驗——C-POST 試驗的數據，該試驗數據顯示疾病復發或死亡的風險顯著降低了 68%。此次獲準擴大並鞏固了利妥昔單抗在非黑色素瘤皮膚癌領域的領先地位。

Moving to fianlimab, our LAG-3 antibody study in combination with Libtayo, our pivotal trial in metastatic melanoma is ongoing with enrollment for our progression-free survival cohort completing last January. And results are now anticipated in the first half of the coming year due to slower rates of event accrual.

接下來是 fianlimab，我們的 LAG-3 抗體研究與 Libtayo 聯合用於治療轉移性黑色素瘤的關鍵性試驗正在進行中，無進展生存期隊列的招募工作已於去年 1 月完成。由於事件累積速度放緩，預計結果將在明年上半年公佈。

Lynozyfic, our BCMAxCD3 bispecific has been approved in the United States and the EU for relapse refractory multiple myeloma. Lynozyfic has the potential for best-in-class efficacy in this late line setting compared to the other approved BSMAxCD3 bispecifics, with almost double the rates of complete responses as reported in the respective label.

我們的 BCMAxCD3 雙特異性抗體 Lynozyfic 已在美國和歐盟獲準用於治療復發難治性多發性骨髓瘤。與其他已核准的 BSMAxCD3 雙特異性藥物相比，Lynozyfic 在後期治療中具有同類最佳的療效潛力，其完全緩解率幾乎是相應標籤中報告的兩倍。

This is the basis for our enthusiasm for studying Lynozyfic in earlier lines of myeloma and even in precursor settings, as a monotherapy or in limited combinations.

這就是我們熱衷於研究 Lynozyfic 在早期骨髓瘤甚至前驅期骨髓瘤中的應用（作為單藥治療或有限的聯合治療）的原因。

Consistent with this, we've recently presented promising Phase 2 results in high-risk smoldering myeloma patients with Lynozyfic monotherapy, demonstrating a 100% objective response rates in 19 evaluable patients, with all six patients who have been followed for at least one year achieving a molecular complete response.

與此一致，我們最近公佈了 Lynozyfic 單藥治療高風險冒煙型骨髓瘤患者的 2 期臨床試驗的有希望的結果，在 19 名可評估的患者中，客觀緩解率達到 100%，所有 6 名接受至少一年隨訪的患者均達到分子完全緩解。

A Phase 3 head-to-head study against Darzalex is planned to start in the coming months with Darzalex having demonstrated a 9% complete response rate in this setting. In addition, we have observed rapid normalization with Lynozyfic monotherapy in previously-treated light chain amyloidosis patients, including patients who have previously received and failed the Darzalex-containing combination chemotherapy.

一項針對達雷妥尤單抗（Darzalex）的 3 期頭對頭研究計劃在未來幾個月內啟動，達雷妥尤單抗在此類研究中已顯示出 9% 的完全緩解率。此外，我們觀察到，對於先前接受過治療的輕鏈澱粉樣變性患者，包括先前接受過含達雷妥尤單抗的聯合化療但治療失敗的患者，使用 Lynozyfic 單藥治療後病情迅速恢復正常。

Finally, I would like to highlight that Lynozyfic has demonstrated an 83% overall response rate as a monotherapy in newly diagnosed multiple myeloma patients with responses deepening over time. Updated results will be reported at a medical meeting later this year. All together, these data give us confidence in terms of pursuing Lynozyfic as a monotherapy or in simplified combination in early line and precursor settings of myeloma.

最後，我想強調的是，Lynozyfic 作為單藥療法，在初診多發性骨髓瘤患者中已顯示出 83% 的整體緩解率，並且隨著時間的推移，緩解程度會加深。更新後的結果將在今年稍後的醫學會議上公佈。綜上所述，這些數據讓我們有信心在骨髓瘤的早期和前驅期治療中，將 Lynozyfic 作為單藥療法或簡化聯合療法進行研究。

Though I won't go into detail on odronextamab today, I want to highlight there are Phase 3 study evaluating odronextamab as first-line monotherapy against the standard of care in follicular lymphoma patients that's fully enrolled. Similarly to Lynozyfic, odronextamab demonstrated potentially best-in-class efficacy in late-line patients, driving our enthusiasm for this approach in the earlier line settings.

雖然我今天不會詳細介紹 odronextamab，但我想強調的是，目前有一項 3 期研究正在評估 odronextamab 作為濾泡性淋巴瘤患者的一線單藥療法與標準療法的療效，該研究已完成招募。與 Lynozyfic 類似，odronextamab 在後期治療患者中表現出潛在的同類最佳療效，這激發了我們對早期治療中採用這種方法的熱情。

I'd also like to remind you that in the leading cohort for this Phase 3 study in first line follicular lymphoma, odronextamab monotherapy demonstrated a 100% complete response rate, further reinforcing the potential of odronextamab in this setting.

我還想提醒各位，在這項針對一線濾泡性淋巴瘤的 3 期研究的主要隊列中，odronextamab 單藥治療顯示出 100% 的完全緩解率，進一步鞏固了 odronextamab 在此治療中的潛力。

Moving on to our C5 and complement inhibitor programs. Let me remind you that in paroxysmal nocturnal hemoglobinuria or PNH, where deep blockade of C5 seems critical to prevent breakthrough hemolysis and potentially catastrophic events, the leading cohort for our Phase 3 study demonstrated there are once-monthly subcutaneous regimen, combining a C5 antibody with a C5 siRNA, may provide the best-in-class disease control with the best-in-class convenience.

接下來，我們將介紹我們的C5和補體抑制劑專案。讓我提醒您，在陣發性睡眠性血紅蛋白尿症 (PNH) 中，深度阻斷 C5 似乎對預防突破性溶血和潛在的災難性事件至關重要。我們 3 期研究的主要隊列表明，每月一次的皮下注射方案，將 C5 抗體與 C5 siRNA 結合，可能提供一流的疾病控制和一流的便利性。

For PNH patients, we have also just initiated our first-in-human study of our siRNA targeting Complement Factor B, primarily intended for the 20% to 30% of patients who remain anemic despite optimal C5 therapy due to so-called extravascular hemolysis.

對於 PNH 患者，我們也剛啟動了針對補體因子 B 的 siRNA 的首次人體研究，主要針對 20% 至 30% 的患者，儘管接受了最佳 C5 治療，但由於所謂的血管外溶血，他們仍然貧血。

Moving on to our C5 program and generalized myasthenia gravis. In the third quarter, we announced positive Phase 3 results for our C5 siRNA, cemdisiran. This siRNA conveniently dosed subcutaneously every three months, shows statistically significant results for the primary endpoint, improvement in the MG-ADL score compared to placebo, and numerically better results compared to other C5 inhibitor therapies in cross-trial comparisons.

接下來是我們的 C5 項目和全身性重症肌無力。第三季度，我們宣布了 C5 siRNA 藥物 cemdisiran 的積極 3 期臨床試驗結果。這種 siRNA 可方便地每三個月皮下注射一次，在主要終點方面顯示出統計學意義上的顯著結果，與安慰劑相比，MG-ADL 評分有所改善，並且在跨試驗比較中，與其他 C5 抑製劑療法相比，數值上的結果更好。

The convenience advantage for patients currently being treated with regular intravenous infusions, together with its efficacy and safety profile, positions cemdisiran as a potential best-in-class treatment option for the debilitating neuromuscular disorder. We are planning on submitting a US regulatory application for cemdisiran monotherapy in the first quarter of 2026, pending FDA discussions, with global submissions to follow.

對於目前接受定期靜脈輸液治療的患者而言，西地西蘭具有便利的優勢，同時兼具療效和安全性，使其成為治療這種致殘性神經肌肉疾病的潛在最佳治療選擇。我們計劃在 2026 年第一季向美國提交 cemdisiran 單藥療法的監管申請，具體時間取決於 FDA 的討論，之後將向全球提交申請。

Finally, for our C5 program, in terms of our efforts in ophthalmology, we are hoping to complete enrollment in the first quarter of 2026 for the leading cohort of our first Phase 3 study in geographic atrophy, with initial results expected by the end of 2026.

最後，就我們的 C5 計畫而言，在眼科方面，我們希望在 2026 年第一季度完成首個地理萎縮 3 期研究的先導隊列的招募工作，預計在 2026 年底獲得初步結果。

Additionally in ophthalmology, I'd like to note that we are initiating a clinical trial in active non-infectious uveitis of an intravitreally-delivered CD3 monoclonal antibody which is designed to locally block autoimmune T cell activity in the eye, marking the first in a new series of novel ophthalmology targets that we will be progressing to the clinic over the next year.

此外，在眼科方面，我想指出，我們正在啟動一項針對活動性非感染性葡萄膜炎的臨床試驗，試驗採用玻璃體內注射的 CD3 單株抗體，旨在局部阻斷眼內自體免疫 T 細胞的活性。這標誌著我們將在未來一年內推進到臨床的一系列新型眼科標靶中的第一個。

Turning to our anticoagulation efforts and in particular, to our Factor XI program involving two different antibodies designed to tailor anticoagulation therapy for each individual patient's needs. Pivotal studies in post-operative venous thromboembolism following total knee replacement surgery are in progress with data anticipated in 2027. Pivotal studies in other anticoagulation indications are set to launch in the coming months.

接下來談談我們的抗凝血治療工作，特別是我們的因子 XI 項目，該項目涉及兩種不同的抗體，旨在根據每位患者的特定需求量身定制抗凝血治療方案。全膝關節置換術後靜脈血栓栓塞的關鍵性研究正在進行中，預計將於 2027 年獲得數據。針對其他抗凝血適應症的關鍵性研究將於未來幾個月啟動。

On November 10, we will kick off a new investor event series called, The Regeneron Roundtable, which will spotlight our various innovative pipeline programs, starting with our Factor XI story in which we will provide, for the first time, exciting new clinical data in trials exploring the Factor XI antibodies in catheter-associated thrombosis in a provoked subclinical GI bleeding study.

11 月 10 日，我們將啟動一項名為「再生元圓桌會議」的全新投資者活動系列，重點介紹我們各種創新研發管線項目，首先是我們的因子 XI 項目，我們將首次提供令人興奮的新臨床數據，這些數據來自一項誘發亞臨床胃腸道出血研究中探索因子 XI 抗體在導管相關血栓形成中的應用的試驗。

Upcoming Regeneron Roundtables will spotlight our opportunities in hematologic and solid tumor oncology, obesity, and other areas.

即將舉行的 Regeneron 圓桌會議將重點介紹我們在血液腫瘤學和實體腫瘤學、肥胖症及其他領域的機會。

Moving to our growing siRNA portfolio, coming out of our research collaboration with Alnylam. I'd like to highlight our ongoing clinical studies, including our PNPLA3 and CIDEB siRNAs in NASH; our SOD and HTT siRNAs in amyotrophic lateral sclerosis and Huntington's disease; and in addition, we plan to begin clinical trials for alpha-synuclein siRNA for Parkinson's disease and our MAP-tau siRNA for Alzheimer's in the coming months.

接下來，我們將介紹我們不斷成長的 siRNA 產品組合，這是我們與 Alnylam 進行研究合作的成果。我想重點介紹我們正在進行的臨床研究，包括我們針對 NASH 的 PNPLA3 和 CIDEB siRNA；我們針對肌萎縮側索硬化症和亨廷頓病的 SOD 和 HTT siRNA；此外，我們計劃在未來幾個月內開始針對帕金森氏症的 α-突觸核蛋白 siRNA 和針對阿茲海默症的 MAP-tau siRNA 的臨床試驗。

Finally, I'd like to highlight our commitment to developing innovative new approaches in the ultra-rare disease space. In the third quarter, we announced unprecedented clinical benefit using garetosmab in our Phase 3 OPTIMA trial in fibrodysplasia ossificans progressiva or FOP. Individuals suffering from this tragic genetic disorder progressively replaced their muscle and soft tissue with abnormal bone formation, encasing themselves in a horrific osseous cage.

最後，我想強調我們致力於在超罕見疾病領域開發創新方法。第三季度，我們宣佈在進行性骨化性纖維發育不良症（FOP）的 3 期 OPTIMA 試驗中，使用 garetosmab 取得了前所未有的臨床獲益。患有這種悲慘的遺傳疾病的人，其肌肉和軟組織會逐漸被異常的骨骼形成所取代，將自己包裹在一個可怕的骨籠中。

Remarkably, in the OPTIMA trial, we're able to demonstrate a greater than 99% reduction in abnormal bone formation at 56 weeks, offering great hope for this ultra-rare genetic disorder. Regeneron plans a US regulatory submission by the end of 2025.

值得注意的是，在 OPTIMA 試驗中，我們能夠證明在 56 週時異常骨形成減少了 99% 以上，這為這種極其罕見的遺傳疾病帶來了巨大的希望。再生元計劃在 2025 年底前向美國監管機構提交申請。

We are also providing new hope for children suffering from another ultra-rare genetic disorder in which absence of the OTOF gene results in profound genetic hearing loss. As we recently described in the New England Journal of Medicine, our novel gene therapy approach provided meaningful hearing gains in 11 out of 12 treated children, with several achieving normal hearing levels.

我們也為患有另一種極其罕見的遺傳疾病的兒童帶來了新的希望，這是由於 OTOF 基因缺失導致的嚴重遺傳性聽力損失。正如我們最近在《新英格蘭醫學雜誌》上所描述的那樣，我們新的基因治療方法使 12 名接受治療的兒童中的 11 名獲得了有意義的聽力改善，其中幾名兒童的聽力達到了正常水平。

The FDA recently announced that this program was the first new molecular entity selected for a Commissioner's National Priority Voucher, and we are finalizing preparations for a US regulatory submission this year. This program highlights Regeneron's commitment to advancing the leading edge of biotechnology.

美國食品藥物管理局 (FDA) 最近宣布，該計畫是第一個被選為局長國家優先憑證的新分子實體，我們正在完成今年向美國監管機構提交申請的準備工作。此計畫彰顯了再生元公司致力於推動生物技術前沿發展的承諾。

In summary, Regeneron has delivered a quarter filled with positive clinical readouts, advancing our pipeline and reinforcing our leadership and scientific innovation, from groundbreaking advance in addressing some of the most common medical conditions, to transformative innovation in the ultra-rare disease space.

總而言之，Regeneron 在本季度取得了一系列積極的臨床結果，推進了我們的研發管線，鞏固了我們的領導地位和科學創新能力，從在解決一些最常見的疾病方面取得突破性進展，到在超罕見疾病領域進行變革性創新。

With that, let me turn it over to Marion.

接下來，我將把麥克風交給瑪莉安。

Thanks, George. Our third quarter performance highlights the strength of Regeneron's commercial portfolio. Today's results demonstrate our ability to drive growth of inline brands and to accelerate launch opportunities, delivering our transformative medicines to even more patients.

謝謝你，喬治。我們第三季的業績凸顯了Regeneron商業產品組合的實力。今天的業績證明了我們有能力推動現有品牌的成長，並加速產品上市，從而將我們具有變革意義的藥物帶給更多的患者。

Beginning with EYLEA HD and EYLEA, total combined third quarter US net sales were $1.11 billion, comparable on a sequential basis. As the decrease in EYLEA net sales was offset by an increase in EYLEA HD net sales, EYLEA HD net sales grew 10% quarter over quarter to $431 million, again, growing faster than any other innovative medicine in the category.

以 EYLEA HD 和 EYLEA 為例，第三季美國淨銷售額合計達 11.1 億美元，季增。由於 EYLEA 淨銷售額的下降被 EYLEA HD 淨銷售額的成長所抵消，EYLEA HD 淨銷售額環比增長 10%，達到 4.31 億美元，再次超過了該類別中任何其他創新藥物的增長速度。

EYLEA HD unit demand grew 18% quarter over quarter which was partially offset by ongoing competitive pricing pressures within the category. As EYLEA HD grew, EYLEA's third quarter US net sales decreased 10% quarter over quarter to $681 million reflecting a commensurate decline in unit demand driven by the ongoing conversion to EYLEA HD, patient affordability issues, and competitive dynamics. We expect a similar demand decline in the fourth quarter for EYLEA, along with ongoing pricing pressure.

EYLEA HD 設備需求較上季成長 18%，但部分被該品類持續的價格競爭壓力所抵銷。隨著 EYLEA HD 的成長，EYLEA 第三季度美國淨銷售額環比下降 10% 至 6.81 億美元，反映出由於持續向 EYLEA HD 轉換、患者負擔能力問題和競爭動態等因素導致單位需求相應下降。我們預期安樂死第四季需求將出現類似下滑，同時價格壓力也將持續存在。

Together, EYLEA HD and EYLEA lead the branded anti-VEGF category based on best-in-class efficacy, safety, and with EYLEA HD durability. And EYLEA HD now represents approximately 40% of Regeneron's US retina franchise.

EYLEA HD 和 EYLEA 共同引領品牌抗 VEGF 品類，憑藉著一流的功效、安全性和 EYLEA HD 的持久性，成為業界翹楚。EYLEA HD 目前約佔 Regeneron 公司美國視網膜產品線的 40%。

Looking ahead to the fourth quarter for EYLEA HD, we anticipate sequential demand growth to moderate to high single-digits as we await label enhancements. Once approved, we believe these enhancements have the potential to generate a significant positive inflection and demand.

展望安樂死高清產品第四季度，我們預期隨著標籤改進的進行，需求季增將達到中等至較高的個位數。一旦獲得批准，我們相信這些改進措施有可能帶來顯著的正向轉變和需求成長。

Now to Dupixent. Third quarter worldwide net sales reached $4.9 billion, growing 26% on a constant currency basis compared to the prior year. In the US, Dupixent's net sales reached $3.6 billion reflecting 28% year-over-year growth. Dupixent leads the market across all established indications including atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis. In addition, Dupixent is the main beneficiary of competitor market growth efforts based on its proven efficacy, safety, ease of access, and ability to address unmet patient needs.

接下來是Dupixent。第三季全球淨銷售額達 49 億美元，以固定匯率計算比上年成長 26%。在美國，Dupixent 的淨銷售額達到 36 億美元，較去年同期成長 28%。Dupixent 在所有已確立的適應症中均處於市場領先地位，包括異位性皮膚炎、氣喘、鼻息肉和嗜酸性食道炎。此外，由於其療效顯著、安全可靠、易於獲取，並且能夠滿足患者未被滿足的需求，Dupixent 成為競爭對手市場成長努力的主要受益者。

Our recent launches in COPD, chronic spontaneous urticaria, and bullous pemphigoid are progressing very well. Across all launches, Dupixent's differentiated clinical profile and growing physician experience are driving strong uptake. In COPD, prescribers see Dupixent's benefits across a range of appropriate patient types, and recent market research found pulmonologists expected to substantially increase their prescribing of Dupixent over the next 12 months.

我們近期在慢性阻塞性肺病、慢性自發性蕁麻疹和類天皰瘡領域推出的產品進展非常順利。在所有上市產品中，Dupixent 差異化的臨床特性和不斷增長的醫生經驗正在推動其強勁的市場接受度。在 COPD 中，處方醫生看到了 Dupixent 對各種合適患者類型的益處，最近的市場調查發現，肺科醫生預計在未來 12 個月內大幅增加 Dupixent 的處方量。

In lung cancer, additionally, there has been rapid uptake among chronic spontaneous urticaria patients as both dermatologists and allergists embraced Dupixent. In bullous pemphigoid, Dupixent is the first biologic medicine addressing a critical unmet need. Physicians are eager to transition elderly patients off steroid therapy, with Dupixent offering them a safer and more effective alternative.

此外，在肺癌領域，慢性自發性蕁麻疹患者也迅速接受了 Dupixent，因為皮膚科醫生和過敏科醫生都接受了這種藥物。在大皰性類天皰瘡領域，Dupixent 是第一個滿足重大未滿足需求的生物製劑。醫生們渴望幫助老年患者停止類固醇治療，而 Dupixent 為他們提供了更安全、更有效的替代方案。

In summary, Dupixent continues to transform the lives of patients across indications, geographies, and age groups from as young as 6 months. There are currently more than 1.3 million patients worldwide benefiting from Dupixent for multiple Type 2 diseases.

總而言之，Dupixent 持續改變著不同適應症、不同地理、不同年齡層患者的生活，甚至適用於 6 個月大的嬰兒。目前全球有超過 130 萬名患者受惠於 Dupixent，用於治療多種第 2 型糖尿病。

Turning to oncology and hematology, in the third quarter, Libtayo delivered $365 million worldwide net sales, growing 24% on a constant currency basis compared with the prior year. In the US, Libtayo net sales grew 12% year over year to $219 million based on strong demand across all approved indications.

再來看腫瘤和血液學領域，Libtayo 第三季全球淨銷售額為 3.65 億美元，以固定匯率計算比上年增長 24%。在美國，由於所有核准適應症的強勁需求，Libtayo 的淨銷售額年增 12%，達到 2.19 億美元。

In non-melanoma skin cancers, Libtayo's strong performance is based on established market leadership in ongoing category growth. We are making encouraging early progress with US launch in adjuvant CSCC where physicians are already embracing Libtayo as a new treatment option. We estimate that up to 10,000 eligible patients may benefit from Libtayo in this setting.

在非黑色素瘤皮膚癌領域，Libtayo 的強勁表​​現源自於其在持續成長的類別中所建立的市場領導地位。我們在美國輔助治療 CSCC 的上市取得了令人鼓舞的早期進展，醫生們已經開始接受 Libtayo 作為新的治療選擇。我們估計，在這種情況下，可能有多達 10,000 名符合條件的患者會從 Libtayo 中受益。

And now, in lung cancer, Libtayo is now the second most commonly prescribed immunotherapy for newly diagnosed patients. Physicians increasingly recognize Libtayo as an important treatment option based on clinical experience, versatility as a monotherapy or in combination with chemotherapy, and in increasing body of clinical evidence including recent five-year survival data.

現在，在肺癌領域，利妥昔單抗已成為新確診患者第二常用的免疫療法。基於臨床經驗、作為單一療法或與化療聯合使用的多功能性，以及越來越多的臨床證據（包括最近的五年生存數據），醫生們越來越認識到 Libtayo 是一種重要的治療選擇。

Outside the US, Libtayo sales reached $146 million, growing 47% year over year on a constant currency basis, supported by sustained demand and ongoing launches in international markets.

在美國以外，Libtayo 的銷售額達到 1.46 億美元，按固定匯率計算同比增長 47%，這得益於持續的需求以及在國際市場上的不斷推出。

Moving to our new hematology therapy, Lynozyfic, we've made strong early progress in commercializing this important bispecific for fifth line multiple myeloma patients. Positive launch indicators include physician feedback, formulary listings, pathway inclusions, completion of REMs requirements, and payer coverage. While we expect modest revenue contribution in this heavily pre-treated population, Lynozyfic is an important therapeutic advance to the hematology community, and we look forward to additional clinical data supporting its potential use in earlier treatment settings.

轉向我們的新血液疾病療法 Lynozyfic，我們在將這種重要的雙特異性藥物商業化方面取得了強勁的早期進展，該藥物適用於五線多發性骨髓瘤患者。積極的上市指標包括醫生回饋、處方集收錄、路徑納入、完成 REM 要求以及支付方覆蓋範圍。雖然我們預計 Lynozyfic 在這部分接受過大量預治療的人群中帶來的收入貢獻有限，但 Lynozyfic 對血液病學界來說是一項重要的治療進展，我們期待獲得更多臨床數據來支持其在早期治療環境中的潛在應用。

In summary, in the third quarter, Regeneron delivered ongoing growths across EYLEA HD, Dupixent, and Libtayo, and made important progress in several launches. Our commercial portfolio is well-positioned to capitalize on many near-term growth opportunities, enabling us to deliver more treatments to more patients.

總而言之，在第三季度，Regeneron 在 EYLEA HD、Dupixent 和 Libtayo 方面實現了持續成長，並在幾項產品上市方面取得了重要進展。我們的商業產品組合佈局合理，能夠抓住許多近期成長機遇，從而為更多患者提供更多治療方案。

With that, I'll turn the call to Chris.

接下來，我將把電話轉給克里斯。

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis unless otherwise noted.

謝謝你，瑪莉安。除非另有說明，我今天對 Regeneron 的財務業績和展望的評論將以非 GAAP 準則為基礎。

Third-quarter 2025 total revenues of $3.8 billion grew 1% compared to the prior year, reflecting higher Sanofi collaboration revenue driven by strong Dupixent sales growth and continued growth in net sales of Libtayo globally and EYLEA HD in the US, partially offset by lower net sales of EYLEA in the US and lower Bayer collaboration revenue. Third quarter diluted net income per share was $11.83 on net income of $1.3 billion.

2025 年第三季總收入為 38 億美元，比上年同期增長 1%，這主要得益於賽諾菲合作收入的增加，而賽諾菲合作收入的增加則主要得益於 Dupixent 銷售的強勁增長以及 Libtayo 在全球範圍內的淨銷售額和 EYLEA HD 在美國的淨銷售額的持續增長以及 Libtayo 在全球範圍內的淨銷售額和 EYLEA HD 在美國的淨銷售額的持續增長。第三季稀釋後每股淨收益為 11.83 美元，淨收益為 13 億美元。

Beginning with the Sanofi collaboration, revenues were approximately $1.6 billion, of which, $1.5 billion related to our share of collaboration profits. Regeneron's share of profits grew 34% versus the prior year driven by volume growth for Dupixent and improving collaboration margins.

從與賽諾菲的合作開始，收入約為 16 億美元，其中 15 億美元與我們在合作中應得的利潤份額有關。受 Dupixent 銷售成長和合作利潤率提高的推動，Regeneron 的利潤份額比上年增長了 34%。

The Sanofi development balance was approximately $900 million at the end of the third quarter, reflecting a reduction of approximately $300 million since the end of the second quarter and approximately $730 million since the start of the year. Dupixent's continued strength has enabled a rapid reimbursement of the development balance in 2025. And we now expect this balance to be fully reimbursed by no later than the end of the third quarter of 2026.

截至第三季末，賽諾菲的研發資金餘額約為 9 億美元，較第二季末減少了約 3 億美元，較年初減少了約 7.3 億美元。Dupixent 的持續強勁表現使得 2025 年能夠迅速償還研發餘額。我們現在預計，這筆餘額最遲將於 2026 年第三季末全部償還。

Moving to Bayer. Third quarter net sales of EYLEA and EYLEA 8 mg outside the US were $854 million, inclusive of $232 million of EYLEA 8 mg sales. Total Bayer collaboration revenue was $345 million, of which, $312 million related to our share of net profits outside the US.

加入拜耳公司。第三季度，EYLEA 和 EYLEA 8 毫克在美國以外的淨銷售額為 8.54 億美元，其中包括 EYLEA 8 毫克的銷售額 2.32 億美元。拜耳合作總收入為 3.45 億美元，其中 3.12 億美元與我們在美國以外的淨利潤份額有關。

Other revenue in the third quarter was $198 million which included $165 million of profit share and royalties associated with license agreements. The increase from the prior year was driven by higher royalty income from Ilaris and growth and our share of profits from Arcalyst.

第三季其他收入為 1.98 億美元，其中包括 1.65 億美元的利潤分成和與授權協議相關的特許權使用費。與前一年相比，成長主要得益於 Ilaris 更高的特許權使用費收入以及 Arcalyst 的成長和我們分得的利潤份額。

Now to our operating expenses. R&D expense was $1.3 billion in the third quarter, reflecting continued investments to support Regeneron's innovative late-stage pipeline, including our pivotal programs for Lynozyfic and Ordspono in earlier lines of myeloma and lymphoma, our Factor XI program in anticoagulation indications, and our ongoing efforts in other clinical programs.

接下來是我們的營運費用。第三季研發支出為 13 億美元，反映了對 Regeneron 創新後期研發管線的持續投資，包括我們在早期骨髓瘤和淋巴瘤治療中的關鍵項目 Lynozyfic 和 Ordspono、我們在抗凝血適應症中的因子 XI 項目，以及我們在其他臨床項目中的持續努力。

Third quarter SG&A was $541 million down 12% from the prior year, primarily driven by lower charitable contributions to an independent non-profit patient assistance foundation. Third quarter 2025 gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects a changing product mix and higher ongoing investments to support our manufacturing operations.

第三季銷售、一般及行政費用為 5.41 億美元，較上年同期下降 12%，主要原因是向獨立的非營利病患援助基金會的慈善捐款減少。2025年第三季淨產品銷售額毛利率為86%。與前一年相比，毛利率下降反映了產品組合的變化以及為支持我們的生產運營而進行的持續投資增加。

Regeneron generated $3.2 billion in free cash flow through the first nine months of 2025 and ended the quarter with cash and marketable securities, less debt, of approximately $16 billion. Through the first nine months of 2025, we have repurchased approximately $2.8 billion of our shares, the most ever allocated to open market repurchases in any full fiscal year in our history. We continue to be opportunistic buyers of our shares and anticipate returning approximately $4 billion to shareholders through dividends and repurchases in 2025.

2025 年前九個月，Regeneron 產生了 32 億美元的自由現金流，並在季度末持有現金和有價證券（減去債務）約 160 億美元。2025 年前九個月，我們已回購了約 28 億美元的股票，這是我們歷史上任何一個完整財政年度分配給公開市場回購的最大金額。我們將繼續伺機買入我們的股票，並預計在 2025 年透過股利和股票回購向股東返還約 40 億美元。

Moving to guidance for 2025. We have updated and narrowed the ranges across our financial guidance which can be found in our press release issued earlier this morning. Finally, as we turn to 2026, we continue to make significant progress across our innovative pipeline and anticipate advancing multiple large registrational programs in myeloma, lymphoma, anticoagulation, obesity, and other hematology in solid tumor oncology programs, as well as several new assets into the clinic.

轉為2025年指導方針。我們已更新並縮小了財務預期範圍，詳情請參閱今天早上發布的新聞稿。最後，展望 2026 年，我們將繼續在創新產品線中取得重大進展，並預計將推進骨髓瘤、淋巴瘤、抗凝血、肥胖症和其他血液學實體瘤腫瘤項目的多個大型註冊項目，以及將幾個新資產推向臨床。

We believe investing in these programs can drive significant long-term value. And to support these efforts, we currently expect a mid-teens percentage increase in R&D expense in 2026 relative to 2025. We will provide details in 2026 guidance for other line items early next year.

我們相信，投資這些項目可以帶來顯著的長期價值。為了支持這些努力，我們目前預計 2026 年研發支出將比 2025 年成長 15% 左右。我們將於明年年初在 2026 年指導文件中提供其他項目的詳細資訊。

In conclusion, Regeneron's third quarter results demonstrate the ongoing strength of our business and enabled us to continue investing in our differentiated pipeline to deliver significant advances for patients and drive long-term value for shareholders.

總之，Regeneron 第三季的業績顯示了我們業務的持續強勁勢頭，並使我們能夠繼續投資於我們差異化的研發管線，從而為患者帶來重大進展，並為股東創造長期價值。

With that, I'll pass the call back to Ryan.

這樣，我就把電話轉回給瑞恩了。

Thank you, Chris. This concludes our prepared remarks. We will now open the call for Q&A. To ensure we are able to address as many questions as possible, we will answer one question from each caller before moving to the next. Shannon, can we please go to the first question, please?

謝謝你，克里斯。我們的發言稿到此結束。現在開始問答環節。為了確保我們能夠解答盡可能多的問題，我們將在回答每位來電者的一個問題後再進行下一位來電者的問題。香農，我們能直接進入第一個問題嗎？

(Operator Instructions)

（操作說明）

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

Hey. Thanks so much. It seems like your team has retooled your commercial strategy on EYLEA and it seems related to kind of price. What are you doing on a ground level when it comes to volume-based discounts it's allowing you to take share from Roche and Amgen? And are you seeing more price erosion on EYLEA? Are we also seeing that discounting on high dose? And maybe just lastly, should we continue to see volume gains and revenue gains ahead of the label enhancement potentially midyear? Thanks so much.

嘿。非常感謝。看來你們團隊已經調整了安永的商業策略，而且這似乎與價格有關。在基於銷售的折扣方面，你們採取了哪些實際措施來從羅氏和安進手中奪取市場份額？你覺得EYLEA的價格下跌趨勢是否更明顯？高劑量產品也有折扣嗎？最後，我們是否應該在年中標籤升級之前繼續看到銷售和收入的成長？非常感謝。

Well, I think you may have set the record for the number of questions we're not going to answer. Not because we don't want to, Marion would love to, but I think that there's so many competitive issues ongoing there in terms of our strategy on the ground, our rebates, and so forth. So I'm not sure we're able to really help you out there. Marion, I don't know if you want to add anything?

嗯，我想你可能已經創造了我們不打算回答的問題數量紀錄了。並非我們不想去，瑪莉昂很想去，但我認為，就我們的實地策略、回扣等等而言，那裡存在太多競爭問題。所以我不確定我們是否真的能幫助你。瑪莉昂，你還有什麼要補充的嗎？

Well, I think I would just add that when we look at the EYLEA HD performance in the quarter, the safe durability profitability that we're seeing certainly is related to EYLEA HD, the product and the science. And retina specialists see the clinical efficacy, the safety, and now durability with EYLEA HD and that is making a big difference.

我想補充一點，當我們審視本季 EYLEA HD 的表現時，我們看到的安全耐用性盈利能力當然與 EYLEA HD 產品及其科學技術有關。視網膜專家們看到了 EYLEA HD 的臨床療效、安全性和持久性，這帶來了巨大的改變。

We do see that until we get these enhancements in place, we can't, I think, see a significant upswing.

我們認為，在這些改進措施落實到位之前，我們無法看到明顯的成長。

Len, if you like, I can highlight what I shared a moment ago, but just to answer the question a bit more completely, for EYLEA HD, I mentioned we anticipate to sequential demand growth to moderate the high single-digits as we await label enhancements. And we also made a comment on EYLEA that we anticipate similar levels of demand reduction in the coming quarter. And as I noted today, we saw a 10% reduction in EYLEA 2 milligrams, and that was in terms of the lower demand quarter over quarter. I hope that's helpful.

Len，如果你願意，我可以強調一下我剛才分享的內容，但為了更完整地回答這個問題，關於EYLEA HD，我提到過，隨著標籤改進的進行，我們預計需求環比增長將放緩至個位數高位。我們也對安永發表了評論，預計下一季需求下降幅度將與此類似。正如我今天提到的，EYLEA 2 毫克的需求量下降了 10%，這是由於季度環比需求下降所致。希望這能幫到你。

Okay. Thanks, Len and Marion. Let's move to the next question, please, Shannon.

好的。謝謝Len和Marion。香農，我們進入下一個問題吧。

Geoffrey Meacham, Citi.

傑弗瑞‧米查姆，花旗集團。

Morning, guys. Thanks for the question. I guess for Chris or Len, I'm utilizing the balance sheet, you guys haven't historically done larger scale BD and it seems like that's going to be the case going forward. But in manufacturing, what's the appetite to further expand your plans that you've announced just so you own all elements of manufacturing? Obviously, that would be viewed pretty favorably by the Trump administration as well. Thank you.

早上好，各位。謝謝你的提問。我想對 Chris 或 Len 來說，我正在利用資產負債表，你們過去沒有進行過大規模的業務拓展，而且看來未來也會如此。但在製造業方面，你們是否有足夠的意願進一步擴大已經宣布的計劃，從而掌控製造業的所有環節？顯然，川普政府也會對此表示相當贊同。謝謝。

Yeah. Great question, Geoff. Just on whether or not we would use our balance sheet for large deals, we certainly have no allergy to doing that, if we saw the right opportunity. So it's not a question of philosophy there. It's really a question of what would make sense where we think we could create additional value.

是的。問得好，傑夫。至於是否會利用資產負債表進行大宗交易，如果我們遇到適當的機會，我們當然不會排除這樣做。所以這不是哲學問題。實際上，問題在於我們認為在哪些方面可以創造額外價值。

In terms of investing further in manufacturing, and as I said during our (inaudible), we've been talking about the need for domestic manufacturing since 2014, I think, in testimony before Congress. We mentioned the over $7 billion investment plan.

至於進一步投資製造業，正如我在（聽不清楚）中所說，自 2014 年以來，我們一直在談論發展國內製造業的必要性，我想，當時我們在國會作證時也談到了這一點。我們提到了超過70億美元的投資計畫。

But I think you do highlight one piece of the whole puzzle that we do not have adequate positioning in is the filling. But I'm pleased to say that we would expect our filling plant to come, which we've invested quite a bit in, Geoff, it's now ready to go, and we expect it to come online during the coming year. So that's a great question, and it should help us sort of control all aspects of the standard biologics manufacturing.

但我認為你指出了整個難題中我們尚未充分定位的一個環節，那就是填充物。但我很高興地告訴大家，我們投入了相當多資金的灌裝廠已經準備就緒，傑夫，我們預計它將在明年投入使用。這是一個很好的問題，它應該有助於我們控制標準生物製劑生產的各個方面。

Okay. Thanks, Len. Shannon, next question, please.

好的。謝謝你，Len。香農，請問下一個問題。

Chris Raymond, Raymond James.

克里斯·雷蒙德，雷蒙德·詹姆斯。

Thanks for taking the question. It's maybe a question on EYLEA HD, Marion, I think I've heard you talk a lot about the importance of the labeling enhancements and Len, I just heard your comment about share and how important they are. But I think we've come to understand maybe the primary need here and the reason for these enhancements and why they're important is for certain clinics to have dosing flexibility so they can center their inventory around one drug. But just maybe, Marion, as you've seen this market evolve, can you talk about how that clinic inventory policies have evolved over time and especially how private equity in the space may be influencing this? Or is this really more of as you're looking to share with clinics that don't necessarily have relatively aggressive inventory policies.

感謝您回答這個問題。這可能是關於 EYLEA HD 的一個問題，Marion，我想我聽過你多次談到標籤增強功能的重要性，Len，我剛剛聽到你關於分享以及它們的重要性的評論。但我認為我們已經逐漸理解了這裡的主要需求，以及這些改進措施的原因和重要性，那就是某些診所需要劑量靈活性，以便他們可以圍繞一種藥物來儲備庫存。但是，瑪麗昂，鑑於你見證了這個市場的演變，你能否談談診所庫存政策是如何隨著時間推移而演變的，特別是私募股權在該領域可能對此產生的影響？或者，您實際上是想與那些庫存政策沒有那麼激進的診所分享資訊嗎？

Thanks. So Chris, my comment will be that the retina community and certainly, retina KOLs, look for the ability to select the right product for their patients. And I'm not an expert in inventory, but I can share with you that EYLEA HD is a newer branded product in the category two years in the market now, certainly, availability, not only inventory-wise, but payer coverage-wise.

謝謝。所以克里斯，我的看法是，視網膜領域的專家，尤其是視網膜領域的意見領袖，都希望能夠為他們的患者選擇合適的產品。我不是庫存方面的專家，但我可以告訴你，EYLEA HD 是該類別中較新的品牌產品，上市已有兩年，當然，其可用性不僅體現在庫存方面，也體現在支付方的覆蓋範圍方面。

And then as I mentioned a moment ago, the most important characteristics of the product is this element Of profound clinical efficacy, safety that people really can count on. And then, of course, with EYLEA HD, they're getting, for appropriate patients, the ability to have durability that is very, very important for the patients and their caretakers.

正如我剛才提到的，該產品最重要的特點是具有顯著的臨床療效和安全性，這一點值得人們信賴。當然，對於合適的患者來說，EYLEA HD 還能提供非常非常重要的持久性，這對患者及其照護者來說至關重要。

Okay. Thanks, Marion. Next question, please.

好的。謝謝你，瑪莉安。下一個問題。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

Hi. Thanks for taking the question. George, you mentioned, it sounds like, likely, you and Sanofi are going to do another Phase 3 trial here for IL-33 in COPD. Can you just talk about any new insights you might have learned that drove the differential outcome in the prior two Phase 3 trials? And then what you think you can change or optimize in a third trial here to improve the likelihood of success? Thank you.

你好。感謝您回答這個問題。喬治，你剛才提到，聽起來你和賽諾菲很可能會在這裡進行另一項 IL-33 治療 COPD 的 3 期試驗。您能否談談您在前兩次 3 期試驗中獲得的任何新見解，這些見解促成了不同的結果？那麼，您認為在第三次試驗中可以改變或優化哪些方面來提高成功率呢？謝謝。

Well, due to competitive issues, I'm not going to really comment on most of your questions there. And as you said, we're going to have a meeting with the FDA and that's going to help us decide on our strategy going forward.

嗯，由於競爭原因，我不會對你們的大部分問題發表評論。正如您所說，我們將與美國食品藥物管理局 (FDA) 舉行會議，這將有助於我們決定未來的策略。

Okay. Thanks so much, George. Next question, please.

好的。非常感謝你，喬治。下一個問題。

Tyler Van Buren, TD Cowen.

泰勒·範·布倫，TD·考恩。

Good morning. Congratulations on the quarter. Can you elaborate on the probability of the late December decision on the RVO and every-four-week dosing filing with the new filler resulting in an approval? And just a quick follow-up would be, is this the same alternate filler that you use for the recent Libtayo adjuvant cutaneous squamous cell carcinoma approval?

早安.恭喜你本季取得佳績。您能否詳細說明一下，12 月底對 RVO 和每四周一次的給藥方案（使用新的填充劑）做出決定並獲得批准的可能性？還有一個後續問題，這是您最近批准用於輔助治療皮膚鱗狀細胞癌的 Libtayo 所使用的同一種替代填充劑？

No, it's a different filler. It's a complicated sort of timeline here. Because the new filler has to undergo its review and it probably in an inspection and review, and it's unclear when that would be done. Ideally, if that could get done before our November timeline for the approval, for the PDUFA date for the RVO q.4., that would really be perfect, and we could get it all wrapped up in late November.

不，這是另一種填充物。這裡的時間線比較複雜。因為新的填充劑需要經過審查，而且很可能需要進行檢查和審查，目前還不清楚何時會進行審查。理想情況下，如果能在 11 月的審批時間表之前完成，也就是 RVO 第四季的 PDUFA 日期之前完成，那就真的完美了，我們可以在 11 月底完成所有工作。

If it turns out that they have to go to December to get the filler approved, hopefully, that would be as far as they have to go. But of course, the FDA looks at all these things pretty carefully. This filler has a very good track record, but it's got to undergo the inspection and so forth. So I suspect that If they got through that in December, then we could rapidly resubmit or maybe the application would still be on file, we don't know exactly. We're going to have discussions with the FDA. But we believe that there is nothing left to do on that application other than to get the filler in place.

如果最終需要等到 12 月才能獲得填充劑的批准，希望到那時就萬事大吉了。當然，FDA會對所有這些事情進行非常仔細的審查。這種填料的過往記錄非常好，但它必須經過檢驗等等。所以我懷疑，如果他們在 12 月完成了那件事，那麼我們就可以迅速重新提交，或者申請可能仍然保留在檔案中，我們並不確定。我們將與美國食品藥物管理局（FDA）進行討論。但我們認為，除了把填充物放好之外，該申請已經沒有什麼可做的了。

So we think we've had very good discussions about label and indications and all, that's fine. But it's not over until it's over, obviously.

所以我們認為我們已經就標籤、適應症等等方面進行了非常好的討論，這很好。但顯然，不到最後一刻，一切都還沒結束。

But ideally, to summarize, if we could get the filler online before the late November date, it could all be wrapped up then. If not, we would expect and hope that that filler would get approved in December. And then rapidly, we would immediately resubmit and the FDA hopefully could act immediately. That's to-date that we can tell you.

總而言之，理想情況下，如果我們能在 11 月底之前把填充內容上線，那麼所有事情就可以在那之前完成了。否則，我們預計並希望該填充劑能在12月獲得批准。然後我們會迅速重新提交，希望FDA能立即採取行動。目前我們只能告訴你這些。

Yes. Thanks, Len. Complicated situation. Let's move to the next question, please.

是的。謝謝你，Len。情況複雜。我們進入下一個問題吧。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Hi, guys. Thank you so much for taking my question. Just taking a step back, can you walk me through some of the internal changes you've made with your regulatory manufacturing teams to prevent the CRLs that we've seen of recent and ensure that products that should be approved get approved and get the patients as quickly as possible? Thank you.

嗨，大家好。非常感謝您回答我的問題。退一步講，您能否向我介紹一下貴公司監管生產團隊為防止近期出現的完全回复函 (CRL) 而進行的內部改革，並確保應該獲得批准的產品能夠盡快獲得批准並惠及患者？謝謝。

Now that's a very pointed question. And I really want to address it head on. The issues that we have had have not been internal regulatory problems. We have a terrific relationship with the FDA. Our regulatory team includes people who used to work at the FDA or people who've been in the industry doing this for decades. There's no shortage of expertise or relationships on a regulatory front. We've certainly asked that question, the Board always ask that question, and there's no issue there.

這真是一個切中要害的問題。我真的很想正面解決這個問題。我們遇到的問題並非內部監管問題。我們與美國食品藥物管理局（FDA）的關係非常好。我們的監管團隊成員包括在 FDA 工作的人員，以及在該行業從事相關工作數十年的人員。在監管方面，我們不缺乏專業知識和人脈關係。我們當然問過這個問題，董事會也總是問這個問題，而且這方面沒有任何問題。

On the manufacturing front, we recognize that it would be more ideal if we could have our own filling. We would have expected to have that by now, but we got delayed dramatically during COVID because of supply chain issues in manufacturing. As I said, we hope that filling will come online next year.

在生產方面，我們認識到，如果我們能夠擁有自己的餡料，那就更理想了。我們原本預計現在應該已經完成了，但由於新冠疫情期間製造業的供應鏈問題，我們的進度被大大延誤了。正如我所說，我們希望明年就能開始灌裝。

In terms of getting backups and what have you, it's a relatively complicated situation. We've been working on backups for quite a long time now. The problem, as you might imagine, is that, for good reason, the FDA is very finicky about showing where you make, what's going to make the product, literally, what equipment it's going to touch, and then you have to do stability testing, and quality testing. All of that for a given filler. And that takes quite a bit of time, quite a bit of resources.

至於備份等方面，情況較為複雜。我們一直在研究備份方案，已經很久了。問題在於，正如你可能想像的那樣，出於充分的理由，FDA 非常嚴格地要求你展示產品的生產地點、生產過程（包括產品將接觸哪些設備），然後你還必須進行穩定性測試和品質測試。所有這些都是為了找到合適的填充物。這需要花費相當多的時間和資源。

So in summary, I don't want to sound offensive at all. We have looked at this. It is not a regulatory problem for us. It is, in some respects, a manufacturing issue in terms of getting online our own filling. Having backup fillers in place is complicated, we're trying to do that.

總而言之，我完全不想冒犯任何人。我們已經研究過了。對我們來說，這不是監管問題。從某種程度上來說，這是我們自己在線上灌裝過程中的一個製造問題。準備備用填充物很複雜，我們正在努力做到這一點。

But our biggest problem, frankly, is the FDA has now paid quite a bit close attention. And I might point out that the biggest companies in the world have had the same issue with fillers where even with the same filler, and they've called us to know how's it going? But they just don't talk about the CRLs that they get, and we know that they're out there. So I'm not sure that we're worse off in that regard. But wherever we are, I'm not happy about it and we're not happy about it, and we're trying to rectify the situation. I hope that gives you a glimpse into our thinking.

但坦白說，我們最大的問題是，FDA現在已經非常密切地關注此事。我還要指出，世界上最大的公司也遇到同樣的填充劑問題，即使使用同一種填充劑，他們也會打電話詢問情況如何？但他們就是不談論他們收到的 CRL，而我們知道這些 CRL 確實存在。所以我不確定我們在這方面是否處境更糟。但無論我們身處何地，我對此都不滿意，我們都對此不滿意，我們正在努力糾正這種情況。希望這能讓您對我們的想法有所了解。

Okay. Let's move to the next question, please.

好的。我們進入下一個問題吧。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，加拿大皇家銀行資本市場。

Good morning. Thanks for taking my question. Just on the pipeline front on the Factor XI antibody program. I don't want you to front run your roundtable, but I know you guys recently started large Phase 2 study for the antibodies in afib. So I'm just curious what you guys are looking for out of that study and maybe out of other Factor XIs in development to move into registrationals in that and other large indications and really accelerate that program? Thanks.

早安.謝謝您回答我的問題。僅就XI因子抗體計畫的研發管線方面而言。我不想讓你搶在圓桌會議之前發言，但我知道你們最近開始了針對心房顫動抗體的大型二期研究。所以我很好奇，你們希望從這項研究以及其他正在研發的因子XI中獲得什麼，以便推進該療法和其他重要適應症的註冊申請，並真正加快該計畫的進展？謝謝。

Well, the Phase 2 study is a running study into what we anticipate to be our Phase 3 pivotal program there. And we are in pivotal programs in other settings where anticoagulation can be important. And of course, what are we looking at? We're trying to understand as well as we can the benefit risk ratio for our two distinct antibodies.

嗯，第二階段研究是對我們預期的第三階段關鍵性項目的持續研究。我們也在其他一些關鍵領域開展項目，在這些領域，抗凝血治療可能非常重要。當然，我們究竟在看什麼？我們正在努力盡可能地了解我們兩種不同抗體的獲益風險比。

We think, in this program, it's all going to be about benefit risk. We think that frankly in some ways, decreases in bleeding risk are going to be frankly more important than, in some cases, the anticoagulation effect. As long as you have anticoagulant effect, but if you have really a safe way of achieving it, we think there's a plethora of settings where these two antibodies can respectively find their place. And particularly, in patients maybe even much larger than the [staph] indication where, right now, use of anticoagulants is very limited because of the bleeding concerns. That's what's really limiting the utilization of anticoagulants more widely across many, many, many more settings.

我們認為，在這個專案中，一切都將圍繞著收益風險。我們認為，坦白說，在某些方面，降低出血風險的重要性可能比抗凝血作用更重要。只要具有抗凝血作用，而且能夠以安全的方式實現，我們認為這兩種抗體可以在許多情況下分別發揮作用。尤其是一些病情可能比[葡萄球菌感染]嚴重得多的患者，由於出血問題，目前抗凝血劑的使用非常有限。這正是限制抗凝血劑在更多更多場合更廣泛使用的真正原因。

And so we think that our approach using two antibodies is going to allow us to really customize and tailorize how individual patients are treated, where we can optimize, we can pick the antibody perhaps with the least bleeding risk for the patients who are most concerned about that while providing a different antibody with maybe higher anticoagulation capability when that's needed.

因此，我們認為，使用兩種抗體的方法將使我們能夠真正客製化和調整個別患者的治療方式，在可以優化的情況下，我們可以為最關心出血風險的患者選擇出血風險最小的抗體，同時在需要時提供抗凝血能力可能更高的另一種抗體。

So we think there's a lot of opportunities here beyond [staph]. We think that's where the major opportunity is today. We do not think that's where the major opportunity is going to be going forward in the future. We're going to where we think the future is not necessarily where the current is right now.

所以我們認為這裡還有很多其他的機會。[葡萄球菌]。我們認為，這就是目前最大的機會所在。我們認為，未來最大的機會不會在那裡。我們要去的地方，我們認為未來未必是現在所在的地方。

And in the future, we'll be having a roundtable to tell him about that.

未來，我們會召開圓桌會議，向他報告此事。

Correct. November 10. Thanks, George. Let's move to the next question, please.

正確的。11月10日。謝謝你，喬治。我們進入下一個問題吧。

Carter Gould, Cantor.

卡特·古爾德，坎托爾。

Good morning. Thanks for taking the question. Len, you highlighted the sort of the meager matching thus far with the foundation and I guess you framed it remaining committing to that funding until the end of the year, which I guess sort of allude to a potential terminus. At some point, maybe at the start of the year, does it warrant taking a different tact if you don't see any other people match your commitment?

早安.感謝您回答這個問題。Len，你強調了迄今為止與基金會的匹配資金少得可憐，我想你也表示會繼續承諾提供資金直到年底，我想這暗示著資金可能會終止。在某個時候，例如年初，如果你發現沒有人能像你一樣投入，是否應該採取不同的策略？

Yeah. I mean, I'd like not to tell people don't bother to make a commitment because we're going to take care of it. That's not our approach. Our approach will be that we will look at it fresh next year and see what the best strategy is to help patients. Good question though.

是的。我的意思是，我不想告訴大家不必費心承諾，因為我們會處理好一切。這不是我們的做法。我們的做法是，明年我們將以全新的視角審視這個問題，看看幫助患者的最佳策略是什麼。問得好。

Thanks, Len. Let's move to the next question, Shannon.

謝謝你，Len。香農，我們來看下一個問題吧。

Cory Kasimov, Evercore.

Cory Kasimov，Evercore。

Good morning, guys. Thanks for taking the question. So on the heels of your positive Phase 3 data for cemdisiran, can you outline how you see the commercial opportunity evolving for gMG and what your plans are in Europe with this asset? Thank you.

各位早安。感謝您回答這個問題。繼 cemdisiran 的積極 3 期臨床試驗數據之後，您能否概述一下您如何看待 gMG 的商業機會發展，以及您在歐洲對該資產的計劃？謝謝。

Before we get to that, maybe, George, could you just remind everybody what's out there and what the limitations of the current therapies are? Because I'm not sure everybody's on the same page on that.

在我們討論這個問題之前，喬治，你能不能先提醒大家目前有哪些療法以及現有療法的限制？因為我不確定大家在這件事上的看法是否一致。

Well, right now, there are two major classes that are being utilized in this space. One, of course, is the C5 class. The other is the FcRn class. In terms of the C5 class, as we know, most of those are administered using these large intravenous infusions which are very inconvenient for the patients. And in terms of the FCRN class, those are given via also intravenous infusions approaches right now or ultimately, they may move to large-volume subcutaneous approaches that are also somewhat difficult to self-administer. But in any case, the issues also have to do with safety and efficacy.

目前，該領域主要有兩種類型的課程正在使用中。當然，其中之一就是C5級。另一個是 FcRn 類別。就 C5 類藥物而言，我們知道，其中大部分都是透過大量靜脈輸液給藥，這對患者來說非常不方便。至於 FCRN 類藥物，目前也是透過靜脈輸注的方式給藥，或者最終可能會改為大容量皮下給藥，但這種方式也比較難以自行給藥。但無論如何，這些問題也與安全性和有效性有關。

The thing that's exciting about our program is unlike the FcRns which, either when you use weekly treatment, you get less benefits, at least cross-studies, from these standard scores; or with the episodic treatment where you have a U-shaped curve where the patients respond deeply, but then, almost revert back to baseline before you give them their next dose.

我們的項目令人興奮之處在於，它與 FcRns 不同，FcRns 要么在使用每周治療時，從這些標準評分中獲得的益處較少（至少在跨研究中如此）；要么在使用間歇性治療時，會出現 U 形曲線，患者反應強烈，但在給予下一劑之前，幾乎恢復到基線水平。

The C5s allow you to have stable deep control through the entire dosing period. And cross-study comparison, our agent seems to have, in terms of the standard measure that is being used to evaluate these, the best cross-trial efficacy that's stable and continuous throughout the dosing period.

C5s 讓您在整個給藥期間達到穩定的深度控制。從跨研究比較來看，就用於評估這些藥物的標準衡量標準而言，我們的藥物似乎具有最佳的跨試驗療效，並且在整個給藥期間保持穩定和持續。

Now, one important feature of all of these agents, obviously, is they all work by suppressing the immune system through various degrees, either the FcRns or the C5 via their inhibition of the complement cascade, they both result potentially concerns with efficacy, in the case of the C5s mostly, meningococcal infections. As you've probably seen with the FcRn class, with longer usage, they've seen serious infections, for example, resurgence of EBV and even fatal EBV infections. So those are concerns with everything that's available in the class.

現在，所有這些藥物的一個重要特點顯然是它們都透過不同程度地抑制免疫系統來發揮作用，無論是透過抑制補體級聯反應來抑制 FcRns 還是 C5，這兩種藥物都可能導致療效方面的問題，尤其是在 C5 的情況下，主要針對腦膜炎雙球菌感染。正如你可能已經看到的，FcRn 類藥物長期使用會導致嚴重的感染，例如 EBV 的復發，甚至致命的 EBV 感染。所以這些都是課堂上所有可用資源都存在的問題。

The thing that's exciting about our program is not only do we seem to have, at least, potentially best-in-class and stable efficacy with dosing using the most convenient dosing regimen which is subcutaneous once-every-three months. Nothing like that's ever been seen for this class delivering this sort of efficacy. But because we only partially inhibit the complement pathway, there is the potential which we will have to get data to support going forward that may offer certain safety benefits for patients.

我們的計畫最令人興奮的地方不僅在於，我們似乎至少有可能擁有同類最佳且穩定的療效，而且採用最方便的給藥方案，即每三個月皮下注射一次。此類產品從未達到如此高的療效。但由於我們只是部分抑制了補體途徑，因此我們未來需要獲得數據支持，才能為患者帶來一定的安全益處。

So the exciting thing about the program is we certainly have the most convenient dosing regimen, we seem to have the most consistent efficacy with cross-study comparisons, the deepest control. And the fact that we don't completely inhibit the target in this class, there is the long-term opportunity that we may be able to show that we may have better safety for patients as well here.

所以，這個方案最令人興奮的地方在於，我們擁有最方便的給藥方案，在跨研究比較中，我們的療效似乎最穩定，控制也最徹底。而且，由於我們無法完全抑制此類藥物中的靶點，因此從長遠來看，我們或許能夠證明，我們也能為患者提供更好的安全性。

So it's a very exciting profile, I think, potentially be able to deliver for this class of patients who are really needing better treatments in terms of convenience, in terms of efficacy, but also in terms of safety. Marion?

所以我認為這是一個非常令人興奮的前景，它有可能為這類真正需要更好治療的患者提供便利、療效和安全性方面的支持。瑪莉安？

Sure. So everything we're doing in the launch strategy for commercialization is based on the very encouraging clinical profile that George is describing. So we're very excited about this opportunity. We will be launch-ready and we do feel for this really important category in patients with unmet need that we potentially have a very highly differentiated product to bring into the marketplace.

當然。因此，我們商業化上市策略中所做的一切都是基於喬治所描述的非常令人鼓舞的臨床概況。所以我們對這個機會感到非常興奮。我們將做好上市準備，我們確實認為，對於存在未滿足需求的患者這一非常重要的類別而言，我們有可能推出一款高度差異化的產品。

Thanks, George and Marion. Let's move to the next question, please, Shannon.

謝謝喬治和瑪麗昂。香農，我們進入下一個問題吧。

Simon Baker, Rothschild & Company Redburn.

西蒙貝克，羅斯柴爾德公司雷德伯恩分公司。

Thank you very much for taking my question. My first ever question on the call. I just wanted to go back to your comments, George, on intravitreally delivered CD3. You're trying it initially in uveitis. I just wonder what the scope of your ambition was in that setting given the role of T cell infiltration in glaucoma which is, obviously, a much bigger indication. Any thoughts on where this could go will be much appreciated. Thank you.

非常感謝您回答我的問題。這是我在電話會議上提出的第一個問題。喬治，我只是想回到你之前關於玻璃體內注射 CD3 的評論。你最初是嘗試用它來治療葡萄膜炎。我只是想知道，考慮到 T 細胞浸潤在青光眼中的作用（顯然，青光眼是一個更重要的適應症），在這種情況下，你的目標範圍有多大。任何關於此事未來發展方向的想法都將不勝感激。謝謝。

I didn't hear what you said about glaucoma. What glaucoma?

我沒聽到你說的關於青光眼的事。什麼青光眼？

So there's some evidence that glaucoma is caused, greater or less part, by T cell infiltration in the eye. So I just wondered if using CD3 antibodies in this setting would potentially encompass that indication as well as uveitis.

因此，有證據表明，青光眼或多或少是由眼內 T 細胞浸潤引起的。所以我想知道，在這種情況下使用 CD3 抗體是否有可能涵蓋該適應症以及葡萄膜炎。

Yeah. We're very excited about our CD3 antibody program, as you mentioned. We believe that this is the world's first complete blocker of CD3 or T cell function that's ever been evaluated in the clinic. There have been partial blocker, partial agonist to-date. We think that going into the eye in uveitis which a lot of data suggests that most, if not all, of these uveitis are related to T cells.

是的。正如您所提到的，我們對CD3抗體計畫感到非常興奮。我們相信這是世界上第一個在臨床上進行評估的完全阻斷 CD3 或 T 細胞功能的藥物。目前已發現部分阻斷劑和部分激動劑。我們認為，進入眼內治療葡萄膜炎，大量數據表明，即使不是全部，大多數葡萄膜炎也與 T 細胞有關。

If we can block the T cells locally without, because the doses that we're going to be using are very low, they're not going to be having systemic effects, you can have really profound benefits in this high unmet need without subjecting patients to any sort of global or systemic immunosuppression.

如果我們能夠局部阻斷 T 細胞，而且由於我們使用的劑量非常低，不會產生全身性影響，那麼就可以在不讓患者接受任何形式的全身性免疫抑制的情況下，真正有效地滿足這一尚未得到滿足的巨大需求。

So we really think this is a very novel, very different approach to active non-infectious uveitis. We think it's the perfect setting to try our CD3 antibody.

因此，我們認為這是一種非常新穎、非常不同的治療活動性非感染性葡萄膜炎的方法。我們認為這是測試我們 CD3 抗體的完美環境。

We have been working a lot on glaucoma. I'm glad that you brought it up. I believe, based on our Regeneron Genetic Center, which are world leaders in understanding the genetic bases of disease, we've, I think uncovered the most important drivers genetically of glaucoma. And we will be rolling out in the very near future our strategy and our programs in a very near clinical program in glaucoma as well.

我們一直在研究青光眼。很高興你提到了這件事。我認為，基於我們 Regeneron 基因中心（該中心在理解疾病的遺傳基礎方面處於世界領先地位），我們已經發現了青光眼最重要的遺傳驅動因素。在不久的將來，我們也將推出我們的策略和方案，並很快啟動青光眼臨床計畫。

So I'm glad you brought it up. I'm glad you're interested in it. But these are going to be two very different distinct programs. We're going to have our CD3 program for non-infectious uveitis. And we're going to be rolling out a very special and very exciting program in glaucoma based entirely on our internally discovered genetics capabilities. We think that these programs really have the opportunity to create entirely new franchises in ophthalmology. The way we think about it, one could be the EYLEA for uveitis; the other could be the EYLEA for glaucoma. So stay tuned.

所以我很高興你提到了這件事。很高興你對此感興趣。但這將是兩個截然不同的獨立項目。我們將開展針對非感染性葡萄膜炎的 CD3 計畫。我們將推出一項非常特別、非常令人興奮的青光眼治療項目，該項目完全基於我們內部發現的遺傳學能力。我們認為這些項目確實有機會在眼科領域創造全新的品牌。我們認為，其中一種可能是治療葡萄膜炎的 EYLEA；另一種可能是治療青光眼的 EYLEA。敬請期待。

Thank you, George. Very exciting. I think we have time for three more questions, Shannon.

謝謝你，喬治。太令人興奮了。香農，我想我們還有時間再問三個問題。

Alexandria Hammond, Wolfe Research.

亞歷山德里亞·哈蒙德，沃爾夫研究公司。

Thanks for taking the question. On the upcoming Libtayo LAG-3 readout, it seems like the goal is to outperform Opdualag. But could you share your confidence in demonstrating a [staph] safe benefit against Keytruda? And as a follow-up, can you tell us a little bit more about the open-label Phase 3 trial you have ongoing against Opdualag? Is it just another show of confidence that your combo can be more potent than the currently approved option?

感謝您回答這個問題。即將發布的 Libtayo LAG-3 讀數顯示，其目標似乎是超越 Opdualag。但是，您能否分享一下您對證明其在抗葡萄球菌感染方面優於 Keytruda 的信心？作為後續問題，您能否詳細介紹您正在進行的針對 Opdualag 的開放標籤 3 期試驗？這是否只是再次展現了你們的信心，認為你們的組合方案比目前獲準的方案更有效？

A lot of questions in there. But first and most importantly, our study is ongoing. As you said, we are trying our combination versus Keytruda. Our hope is that the Keytruda will behave as it has more or less historically. And our hope is that, remember, we have two arms in the study, a low dose and the high dose, that the two arms, at least one of them, will behave better than the Keytruda arm.

裡面有很多問題。但首先也是最重要的是，我們的研究仍在進行中。正如你所說，我們正在嘗試將我們的組合療法與 Keytruda 進行比較。我們希望 Keytruda 的表現能與它歷史上的表現大致相同。我們希望，記住，這項研究有兩個組，低劑量組和高劑量組，這兩個組，至少其中一個組的表現會比 Keytruda 組更好。

The way we power the study is that we powered it to not only hit PFS and OS. And with the minimal expectation that if we have Opdualag-like activity, we've powered the study so that we can win in both PFS, but also where Opdualag failed in OS.

我們進行這項研究的方式是，我們不僅要達到 PFS 和 OS 的目標，還要努力實現這一目標。我們最低的預期是，如果我們能獲得類似 Opdualag 的活性，那麼我們已經為這項研究提供了足夠的動力，以便我們不僅能在 PFS 方面取得成功，還能在 Opdualag 失敗的 OS 方面取得成功。

If, as you mentioned, we have better data than Opdualag, then obviously, we will significantly win even more than that. So we've powered the study for a minimal of Opdualag-like benefit, but so as to have a large enough OS signal so that we will win with comparable data there.

如您所說，如果我們擁有比 Opdualag 更好的數據，那麼很顯然，我們將贏得更多。因此，我們進行這項研究的目的是為了獲得與 Opdualag 類似的最小益處，但同時也要有足夠大的 OS 訊號，以便我們能夠憑藉可比較數據贏得勝利。

Of course, the data will speak for itself. We'll see whether or not we end up having better efficacy than Keytruda, better efficacy cross-study comparison in Opdualag, and so forth. But we continue to be excited obviously about this program. There's obviously a high need here. There was very exciting earlier trial data using our fianlimab antibody. And so we are anxious but excited about awaiting the data readout next year.

當然，數據本身會說明一切。我們將看看最終療效是否優於 Keytruda，Opdualag 的跨研究療效比較是否更佳等等。但我們顯然仍然對這個項目感到興奮。顯然，這裡的需求非常大。我們先前使用 fianlimab 抗體進行的試驗數據非常令人振奮。因此，我們既焦慮又興奮地期待明年的數據公佈。

Yeah. First half of next year is the timing on that. Shannon, next question, please.

是的。預計明年上半年就能完成。香農，請問下一個問題。

Chris Schott, J.P. Morgan.

克里斯‧肖特，摩根大通。

Great. Thanks so much. Just a quick one on the launch of linvoseltamab. Just how's that progressing versus expectations? And can you just elaborate a bit on the timelines of when you could actually get this product into some of those earlier lines of therapy given the profile that seems to be shaping up here? Is there an ability to pull that forward or accelerate that all in terms of working with FDA, et cetera? Thank you.

偉大的。非常感謝。簡單介紹一下linvoseltamab的上市情況。進展與預期相比如何？鑑於目前看來該產品的發展前景，您能否詳細說明一下，您預計何時才能將其納入一些早期治療方案中？是否有能力在與FDA等機構合作方面推進或加速這項進程？謝謝。

So I can take the first portion on the launch and then I'm sure George will come in on the rest. But certainly, it's early days. But as I mentioned, the progress has been very, very good. We've seen the typical indicators when you have a successful launch ongoing. Physician feedback has been very favorable. Our formulary listings, pathway inclusion, REMS requirements, payer coverage. So we are pleased with that we're seeing so far. And certainly, the enthusiasm of the hematology community for Lynozyfic is high. Keeping in mind this is the fifth line setting for multiple myeloma patients, so a heavily pretreated population. But to George for earlier lines.

所以我可以先負責發射的第一部分，然後我相信喬治會接手剩下的部分。當然，現在下結論還為時過早。但正如我所說，進展非常非常好。我們已經看到了成功發佈時的一些典型指標。醫生們的回饋非常正面。我們的藥品目錄、治療途徑納入、REMS 要求、支付方涵蓋範圍。所以，我們對目前為止看到的情況感到滿意。當然，血液學界對 Lynozyfic 的熱情很高。請記住，這是多發性骨髓瘤患者的第五線治療方案，因此患者群體先前接受過大量治療。但要感謝喬治之前說過的話。

Well, we believe that if one looks at the totality of the data, certainly, if it was me or somebody that I cared about, giving the late-stage patients any of these treatments, I think, Lynozyfic would be the choice based on all the available data out there.

我們認為，如果綜合所有數據來看，如果是我或我關心的人，要給晚期患者選擇任何一種治療方案，根據所有現有數據，我認為 Lynozyfic 將是最佳選擇。

And importantly, what this says, if it looks like it has the potential for impressively more benefit in the late-line patients, that of course suggests that it should have also the best benefit for the earlier-stage patients. Because of that, we've taken on a lot of very aggressive programs in the early stages, not only in first line myeloma and in second line myeloma, but in the pre-malignant settings. As I summarized, we now have data in most of these settings, either as monotherapy or in very limited combinations, most of which we've now presented to varying degrees.

更重要的是，這表明，如果它在晚期患者中顯示出顯著的益處，那麼它當然也應該對早期患者有最大的益處。正因如此，我們在早期階段開展了許多非常積極的項目，不僅包括第一線多發性骨髓瘤和二線多發性骨髓瘤，還包括癌前病變。正如我總結的那樣，我們現在在大多數這些情況下都有數據，無論是作為單一療法還是非常有限的組合療法，其中大部分我們已經在不同程度上進行了展示。

And the data really is stunning and unprecedented. We're having a high rate of seeing molecular complete responses in smoldering in, amyloidosis which is a premalignant condition, but where the protein made by the abnormal cells can cause problems. Once again, unprecedented monotherapy activity in the first line setting, we've described that. And in later-line settings, with new combinations that we're also trying, unprecedented levels of activity.

這些數據確實令人震驚，前所未有。我們發現，在隱匿性澱粉樣變性（一種癌前病變，但異常細胞產生的蛋白質可能會引起問題）中，分子完全緩解率很高。我們已經描述過，單藥治療在一線治療中再次展現出前所未有的療效。在後續的生產線設定中，我們也在嘗試新的組合，達到了前所未有的活躍水準。

So we think that this program really has the potential to change the face of treatment for these disease indications in all of its manifestations, whether it be premalignant precursor settings, whether it's early Lyme disease, whether it's second Lyme disease, or whether it's for the late-stage patients.

因此我們認為，該計畫確實有可能改變這些疾病適應症在所有表現形式中的治療面貌，無論是癌前病變、早期萊姆病、繼發性萊姆病，還是晚期患者。

So I think this is an exciting time for the field. And I just want to remind you that in many ways, our odronextamab program is quite similar in that particular in follicular lymphoma where we look like we have the best late-line data, we're going aggressively in earlier Lyme disease. And once again, we've released the data-leading cohorts of Phase 3s as monotherapy and so forth. Once again, unprecedented efficacy in these small initial cohorts that we're looking at which really get us excited that these bispecifics really have the chance to really change the hematologic oncology space in their respective settings.

所以我認為這對這個領域來說是一個令人興奮的時刻。我只想提醒大家，在很多方面，我們的 odronextamab 計畫與濾泡性淋巴瘤非常相似，尤其是在我們擁有最佳後期治療數據的濾泡性淋巴瘤領域，我們正在積極推進早期萊姆病的治療。我們再次發布了 3 期單藥治療等研究的領先數據隊列。再次，我們在這些小型初始隊列中觀察到了前所未有的療效，這讓我們非常興奮，因為這些雙特異性抗體真的有機會在各自的環境中真正改變血液腫瘤學領域。

Let me just say, before we go to the next question, one is I think inherent to what George is saying there is that all bispecifics are not created equal. The team spends an enormous amount of time with all the technology at hand to select and create bispecifics that we think are different, fundamentally different. And that's why we think we're seeing better data.

在我們討論下一個問題之前，我想先說明一點：我認為喬治所說的內容中固有的一個問題是，並非所有的雙特異性抗體都是平等的。團隊花費大量時間，利用所有現有技術，選擇並創造我們認為與眾不同、本質上不同的雙特異性抗體。這就是為什麼我們認為我們看到了更好的數據。

I just also want to emphasize, we're making a huge commitment here. We expect to conduct as many as 10 registration of trials for Lynozyfic including, as George outlined, a broad registration program in frontline or even earlier myeloma patients, both for transplant eligible and ineligible. This is a big space. It's a $30 billion market potential. Darzalex alone is annualizing at $15 billion. You saw some cross-study data that suggests that we can outperform. We've had some success where Darzalex has already failed in the IgA space. And we've had some success in cross-study comparisons in the smoldering.

我還要強調一點，我們在這裡做出了巨大的承諾。我們預計將進行多達 10 項 Lynozyfic 註冊試驗，其中包括 George 概述的一項針對一線甚至更早期多發性骨髓瘤患者的廣泛註冊計劃，包括適合移植和不適合移植的患者。這是一個很大的空間。這是一個價值300億美元的市場潛力。光是達雷妥尤單藥年銷售額就高達 150 億美元。你看到了一些交叉研究數據，這些數據顯示我們可以做得更好。在IgA領域，Darzalex已經失敗的地方，我們取得了一些成功。我們在陰燃現象的交叉研究比較中取得了一些成功。

So I think this is pretty exciting. As George outlined, it's a huge commitment. You expect us to spend a lot and go very -- as fast as we can. Somebody asks about can we accelerate with the FDA. We're certainly going to talk with the FDA and advise them that we think we have the best program, how can we work together?

所以我覺得這很令人興奮。正如喬治所說，這是一項巨大的投入。你希望我們花很多錢，而且盡可能快地完成任務。有人問我們能否加快向FDA申請審批。我們一定會和FDA談談，告訴他們我們認為我們有最好的方案，該如何合作？

You meant amyloidosis, not IgA.

你說的是澱粉樣變性，不是IgA。

Sorry. I meant amyloidosis. Thank you,

對不起。我指的是澱粉樣變性。謝謝你，

Thank you, Len and George. We also look forward to having a Regeneron roundtable on Lynozyfic in December of this year. So let's move to our final question, Shannon.

謝謝Len和George。我們也期待今年 12 月 Regeneron 公司就 Lynozyfic 舉辦圓桌會議。那麼，香農，讓我們進入最後一個問題。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good morning. Thanks for taking my question. You spoke to novel targets here in I&I and ophthalmology, on the GA program in particular, can you speak to what the FDA may be looking for potential study designs, whether it's slowing (inaudible) lesion growth or vision improvements and whether you need to evaluate against current agents? And just remind us on the I&I side when we might hear about these novel targets. Thank you.

早安.謝謝您回答我的問題。您在這裡談到了免疫和感染以及眼科領域的新靶點，特別是全身性關節炎項目，您能否談談FDA可能在潛在的研究設計中尋找什麼，是減緩（聽不清的）病變生長還是改善視力，以及是否需要與現有藥物進行比較？也請您在研發部門提醒我們，何時會聽到這些新目標的訊息。謝謝。

Well, in terms of GA, we've already designed and planned our pivotal readout study for geographic atrophy. We are able to go against placebo. And we're primarily looking at slowing down of growth together with, of course, vision and control. And as I said, we have data from the cohort A from our Phase 3 trial where we expect readout in the second half of 2026 which really will help inform whether this novel systemic approach, which have a lot of advantages in terms of the issues of having to bilaterally inject two eyes multiple times as opposed to being able to systemically treat, we'll know whether there's a real opportunity there or not from that data.

就地理萎縮而言，我們已經設計並規劃了關鍵的地理萎縮讀出研究。我們能夠對抗安慰劑效應。我們主要著眼於放緩成長速度，當然，也包括遠見卓識和有效管控。正如我所說，我們有來自 3 期試驗 A 組的數據，預計將於 2026 年下半年公佈結果，這將有助於我們了解這種新型全身治療方法是否具有真正的價值。這種方法在解決需要多次雙眼注射的問題方面有很多優勢，而全身性治療則無需如此。我們將從這些數據中知道是否存在真正的機會。

I think that in terms of our I&I programs, I think you'll probably be hearing about one of the first one, additional ones, additionally to the CD3 program, which obviously are related I&I and ophthalmology program, you'll be hearing it roll out over the next couple of months with hopefully a new clinical program initiating next year.

我認為就我們的 I&I 項目而言，你可能會聽到一些消息，其中一部分是首批項目，還有一些是 CD3 項目之外的其他項目，這些項目顯然與 I&I 和眼科項目相關，你會在接下來的幾個月裡聽到這些項目陸續推出，希望明年能啟動一個新的臨床項目。

Okay. I appreciate everyone's patience, we went a little over time; and appreciate your interest in Regeneron. Apologies to those who remained in the Q&A queue who we did not have a chance to hear from today. As always, the Investor Relations team here at Regeneron is available to answer any remaining questions you may have. Thank you once again and have a great day.

好的。感謝大家的耐心，我們稍微超時了一點；也感謝大家對 Regeneron 的關注。對於今天未能與仍在問答隊列中的朋友，我們深表歉意。像往常一樣，Regeneron 的投資者關係團隊隨時準備回答您可能還有的任何問題。再次感謝，祝您今天過得愉快。

This concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。