雷傑納榮製藥 (REGN) 2025 Q2 法說會逐字稿

Welcome to the Regeneron Pharmaceuticals second quarter 2025 earnings conference call. My name is Shannon and I will be your operator for today's call. (Operator Instructions) Please note that this conference call is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President-Investor Relations. You may begin.

歡迎參加再生元製藥 2025 年第二季財報電話會議。我叫香農 (Shannon)，今天我將擔任您的電話接線生。（操作員指示）請注意，本次電話會議正在錄音。現在我將把電話轉給投資者關係資深副總裁 Ryan Crowe。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 second quarter of 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。向全世界聽眾致上最誠摯的問候：早安、下午好、晚上好。感謝您對 Regeneron 的關注，歡迎參加我們 2025 年第二季財報電話會議。電話會議結束後不久，本次電話會議的存檔和記錄將在 Regeneron 投資者關係網站上提供。

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 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.

參加今天電話會議的還有董事會聯席主席、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。在我們準備好發言之後，剩餘的時間將用於問答。

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 and business, financial forecasting guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, intellectual property, pending litigation and other proceedings, and competition.

我想提醒您，今天電話會議的言論可能包括 Regeneron 的前瞻性陳述。此類聲明可能包括但不限於與再生元及其產品和業務、財務預測指南、開發計劃和相關預期里程碑、合作、財務、監管事項、付款人承保和報銷、智慧財產權、未決訴訟和其他程序以及競爭相關的聲明。

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found on Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 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.

每個前瞻性陳述都存在風險和不確定性，可能導致實際結果和事件與該陳述中的預測有重大差異。有關這些風險和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，包括今天上午向美國證券交易委員會提交的截至 2025 年 6 月 30 日的季度 10-Q 表。無論是因為新資訊、未來事件或其他原因，Regeneron 均不承擔更新任何前瞻性聲明的義務。

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 and 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 Regeneron 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 GAAP 財務指標以及這些指標與 GAAP 的調節的信息，請參閱我們的季度業績新聞稿和公司介紹，這兩份文件均可在 Regeneron 投資者關係網站上找到。通話結束後，IR 團隊將隨時解答您的任何進一步的問題。

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

接下來，請允許我將電話轉給我們的總裁兼執行長 Leonard Schleifer 博士。Len，請繼續。

Thanks, Ryan. Thanks for you and everybody else who's joining today's call. For my remarks today, I will review some of our key performance drivers from the second quarter, then briefly discuss some pipeline advances we have made this year, and close with some comments on our capital allocation principles. I will then hand the call over to George, who will provide more details on our pipeline progress, while also highlighting some exciting emerging data from lead-in cohorts for our pivotal programs in myeloma and lymphoma. From there, Marion will review our commercial performance. And finally, Chris will detail our quarterly financial result and provide an update on our 2025 financial guidance.

謝謝，瑞安。感謝您和所有參加今天電話會議的人。在今天的演講中，我將回顧第二季度的一些關鍵業績驅動因素，然後簡要討論我們今年取得的一些進展，最後對我們的資本配置原則發表一些評論。然後，我將把電話交給喬治，他將提供有關我們管道進展的更多細節，同時還將重點介紹我們在骨髓瘤和淋巴瘤方面的關鍵項目的導入隊列中的一些令人興奮的新興數據。從那裡，馬里恩將審查我們的商業表現。最後，克里斯將詳細介紹我們的季度財務業績，並提供 2025 年財務指導的最新資訊。

We turned around and delivered a strong second quarter, driven by durable growth drivers across our commercial portfolio. Worldwide net product sales are Dupixent increased by 21% and Libtayo by 25% at constant exchange rates; while EYLEA HD in the US grew by 29%, compared to the second quarter of last year.

由於商業投資組合的持久成長動力，我們扭轉了頹勢，在第二季度取得了強勁表現。以固定匯率計算，全球淨產品銷售額 Dupixent 成長了 21%，Libtayo 成長了 25%；而美國的 EYLEA HD 成長了 29%，與去年第二季相比。

With respect to EYLEA, second quarter 2025 US net product sales were $754 million, down 39% compared to the second quarter of last year. Sequentially, compared to the first quarter of 2025, physician unit demand declined by 10%, but net product sales were favorably impacted by prior-period inventory dynamics.

就EYLEA而言，2025年第二季美國淨產品銷售額為7.54億美元，與去年第二季相比下降39%。與 2025 年第一季相比，醫生單位需求下降了 10%，但淨產品銷售額受到前期庫存動態的正面影響。

We expect ongoing switches to EYLEA HD competitive pressures, patient affordability issues, and pricing to continue to negatively impact EYLEA US net product sales going forward. EYLEA HD had a very encouraging performance in the second quarter with US net product sales reaching $393 million an all-time high, driven by a notable step-up in physician unit demand.

我們預計，持續轉向 EYLEA HD 的競爭壓力、病患負擔能力問題以及定價將繼續對 EYLEA 美國未來的淨產品銷售產生負面影響。EYLEA HD 在第二季表現非常令人鼓舞，受醫師單位需求顯著增加的推動，美國淨產品銷售額達到 3.93 億美元，創歷史新高。

Future product enhancements, including pre-filled syringe administration, and every four-week dosing interval for proved indications and the addition of macular edema following retinal vein occlusion or RVO are expected to help further realize EYLEA HD commercial opportunity.

未來的產品改進，包括預充式註射器給藥、針對已證實適應症的每四周給藥間隔以及視網膜靜脈阻塞或 RVO 後的黃斑水腫治療，預計將有助於進一步實現 EYLEA HD 的商業機會。

These EYLEA HD enhancements are now likely to be delayed from the August 2025 PDUFA dates as a result of observations from an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana LLC, which was recently acquired by Novo Nordisk A/S.

根據 FDA 對這些監管應用的填充劑 Catalent Indiana LLC（該公司最近被 Novo Nordisk A/S 收購）進行一般現場檢查的觀察結果，這些 EYLEA HD 增強功能現在可能會從 2025 年 8 月的 PDUFA 日期推遲。

Prior to its acquisition, this site was owned and operated by Catalent Inc, a leading contract manufacturer that in their fiscal year 2024 produced nearly 70 billion unit doses and did business with the vast majority of the top biopharmaceutical companies in the world. This inspection was completed in mid-July and was not specific to EYLEA HD. Novo has been in communication with the FDA and expects to file its comprehensive and robust response next week.

在被收購之前，該工廠由 Catalent Inc 公司擁有和運營，該公司是一家領先的合約製造商，在其 2024 財年生產了近 700 億單位劑量，並與世界上絕大多數頂級生物製藥公司開展業務。此次檢查於 7 月中旬完成，並非針對 EYLEA HD。Novo 一直與 FDA 保持溝通，預計下週提交全面而有力的回應。

Based on our review of the observation and Novo's proposed response, along with the progress we have made with alternate third-party fillers, we anticipate an expeditious resolution of our filling issues for EYLEA HD.

根據我們對觀察結果和 Novo 提出的回應的審查，以及我們在替代第三方填充劑方面取得的進展，我們預計 EYLEA HD 的填充問題將迅速解決。

The BLA for odronextamab, a bispecific antibody targeting CD20 and CD3 for relapsed/refractory follicular lymphoma was also impacted by the Catalent Indiana LLC site inspection and resulted in the FDA issuing a CRL earlier this week.

odronextamab 是一種針對復發/難治性濾泡性淋巴瘤的雙特異性抗體，其 BLA 也受到了 Catalent Indiana LLC 現場檢查的影響，並導致 FDA 於本週早些時候發布了 CRL。

Going to Dupixent. Second quarter 2025 global net product sales were $4.3 billion, up 21% on a constant currency basis versus the second quarter of 2024. Now annualizing at over $17 billion, Dupixent global growth continues across all approved indications in all approved age groups and across geographic regions.

前往 Dupixent。2025 年第二季全球淨產品銷售額為 43 億美元，以固定匯率計算比 2024 年第二季成長 21%。Dupixent 的年銷售額目前已超過 170 億美元，其全球成長仍在繼續，涵蓋所有核准適應症、所有核准年齡層和所有地理區域。

In the US, Dupixent net product sales grew 23% to the second quarter of last year and continues its leadership position in both new-to-brand prescription share and total prescription share across all indications approved prior to this year.

在美國，Dupixent 淨產品銷售額截至去年第二季度增長了 23%，並繼續在新品牌處方份額和今年之前批准的所有適應症的總處方份額中保持領先地位。

Over the past 10 months, three new indications, chronic obstructive pulmonary disease or COPD, chronic spontaneous urticaria or CSU, and bullous pemphigoid or BP were approved by the FDA, enabling Dupixent to potentially treat more than 600,000 additional biologic eligible patients. These approvals bring the total addressable population for Dupixent in the US to over 4 million patients, of which, only a small fraction are being actively treated, positioning Dupixent to remain a strong growth driver over the near, medium, and long term.

在過去的 10 個月中，FDA 批准了三種新的適應症，即慢性阻塞性肺病 (COPD)、慢性自發性蕁麻疹 (CSU) 和大皰性類天皰瘡 (BP)，這使得 Dupixent 有可能治療超過 60 萬名額外的生物製劑合格患者。這些批准使 Dupixent 在美國的總目標族群超過 400 萬名患者，其中只有一小部分正在接受積極治療，這使得 Dupixent 將在近期、中期和長期內繼續成為強勁的成長動力。

Global Libtayo net product sales grew 25% on a constant currency basis compared to the second quarter of last year and are now annualizing at $1.5 billion. In the US, where net product sales grew 16%, Libtayo continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers while building share in the lung cancer market.

與去年第二季相比，Libtayo 全球淨產品銷售額以固定匯率計算成長了 25%，目前年銷售額達到 15 億美元。在美國，淨產品銷售額成長了 16%，Libtayo 繼續成為晚期非黑色素瘤皮膚癌市場領先的免疫療法，同時在肺癌市場中佔有份額。

We are looking forward to the FDA decision and potential launch later this year of Libtayo in high-risk adjuvant cutaneous squamous cell carcinoma where Libtayo has the potential to become the standard of care. If approved, Libtayo will be the first and only PD-1 antibody for this setting and would represent a significant advance for the up to 10,000 addressable patients in the US who could benefit from this treatment.

我們期待 FDA 的決定以及 Libtayo 在今年稍後推出用於治療高風險輔助皮膚鱗狀細胞癌的潛力，Libtayo 有可能成為該治療的標準。如果獲得批准，Libtayo 將成為第一個也是唯一一個針對這種情況的 PD-1 抗體，並將為美國多達 10,000 名可從該治療中受益的患者帶來重大進步。

Moving to our pipeline, which now includes approximately 45 product candidates in various stages of clinical development. We continue to make significant investments in R&D that have yielded notable progress across several key programs so far this year, which George will discuss in just a moment.

轉向我們的產品線，目前包括處於不同臨床開發階段的約 45 種候選產品。我們繼續在研發方面進行大量投資，今年到目前為止，幾個關鍵項目已經取得了顯著進展，喬治稍後將對此進行討論。

Over the next six months, we anticipate Phase 3 data for our C5 program in generalized myasthenia gravis for fianlimab, our LAG-3 antibody, in combination with Libtayo in advanced melanoma. For garetosmab, our Activin A antibody in fibrodysplasia ossificans progressiva or FOP. And our programs for birch and cat allergies. We also expect to make a decision on next steps for itepekimab in COPD.

在接下來的六個月中，我們預計將獲得我們的 LAG-3 抗體 fianlimab 與 Libtayo 聯合治療全身性重症肌無力的 C5 項目的第 3 階段數據。對於 garetosmab，我們的 Activin A 抗體可用於治療進行性骨化性纖維發育不良症或 FOP。還有我們針對樺樹和貓過敏的計畫。我們也希望就伊替米單抗治療 COPD 的下一步措施做出決定。

Several differentiated early clinical and preclinical programs spanning hematology, genetic medicines, ophthalmology, oncology, and immunology represent an exciting next wave of innovations at Regeneron.

再生元的幾個差異化的早期臨床和臨床前項目涵蓋血液學、基因藥物、眼科學、腫瘤學和免疫學，代表再生元令人興奮的下一波創新浪潮。

Finally, I'd like to provide an update on how we're thinking about allocating shareholder capital. At our core, we firmly believe that internal investment offers the greatest potential return for shareholders. Therefore, we plan to continue investing heavily in our internal R&D programs, while also making significant capital investments in the United States to support anticipated future growth.

最後，我想介紹一下我們如何考慮分配股東資本。我們始終堅信內部投資能為股東帶來最大的潛在回報。因此，我們計劃繼續大力投資我們的內部研發項目，同時在美國進行大量資本投資以支持預期的未來成長。

We're investing over $7 billion in the US over the coming years to expand our research and development capabilities and our manufacturing network, including a brand new state-of-the-art finished manufacturing facility in Rensselaer, New York. We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends. And we remain committed to funding both for the foreseeable future.

未來幾年，我們將在美國投資超過 70 億美元，以擴大我們的研發能力和製造網絡，包括在紐約州倫斯勒建立一個全新的最先進的成品製造工廠。我們也認為，這些關鍵投資應該透過股票回購和股利直接向股東返還資本來補充。在可預見的未來，我們仍將致力於為這兩項事業提供資金。

Given the strength of a balance sheet, we also have the flexibility to engage in business development, and our focus remains on opportunities that can accelerate or strengthen our existing R&D capabilities. We have historically focused mainly on early-stage assets and innovative platform technologies with significant synergies to our internal R&D efforts, while also considering differentiated later-stage opportunities in areas with high unmet medical need that complement our R&D focus.

鑑於資產負債表的強勁，我們還可以靈活地參與業務發展，我們的重點仍然是可以加速或加強我們現有研發能力的機會。我們歷來主要關注早期資產和創新平台技術，這些技術與我們的內部研發工作具有顯著的協同作用，同時也考慮在未滿足醫療需求較高的領域中尋找差異化的後期機會，以補充我們的研發重點。

In closing, Regeneron's business remains sound with impressive commercial execution, driving strong financial results in the second 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. Finally, we continue to prudently deploy capital with the goal of delivering long-term value to shareholders.

最後，再生元的業務依然穩健，商業執行力令人印象深刻，推動第二季財務業績強勁。我們的研發管線即將帶來科學突破，有可能幫助治療數百萬患者並轉化為有意義的商業機會。商業團隊在成功推出新產品的同時，仍致力於最大限度地發揮我們直列品牌的成長動力。最後，我們繼續審慎地部署資本，目標是為股東創造長期價值。

With that, I'm now turning the call over to George.

現在，我將把電話轉給喬治。

Thanks, Len. I'll start with Dupixent, which continues to set a high bar across multiple Type 2 allergic diseases. Dupixent achieved another recent milestone as the first and only FDA-approved targeted medicine for bullous pemphigoid, a chronic debilitating and relapsing rare skin disease. Dupixent is now approved in the United States to treat eight distinct diseases driven by Type 2 inflammation, including diseases affecting the skin, the gut, and respiratory system. And it can impact a broad range of patients from infants to elderly individuals. And as Len highlighted, Dupixent is the leading biologic treatment in its first six approved indications.

謝謝，Len。我首先要說的是 Dupixent，它在多種 2 型過敏性疾病中繼續設定了高標準。Dupixent 最近取得了另一個里程碑，成為第一個也是唯一一個獲得 FDA 批准的針對大皰性類天皰瘡（一種慢性衰弱性和復發性罕見皮膚病）的標靶藥物。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，包括影響皮膚、腸道和呼吸系統的疾病。它可以影響從嬰兒到老年人的廣泛患者。正如 Len 所強調的，Dupixent 是其前六種核准適應症中領先的生物製劑治療藥物。

We also remain excited about the potential for Dupixent in the elimination and treatment of allergies, as well as a number of other approaches we are pursuing for allergies, such as our cat- and birch-specific allergy programs with updates on these programs expected later this year.

我們也對 Dupixent 在消除和治療過敏方面的潛力以及我們正在針對過敏採取的許多其他方法感到興奮，例如我們針對貓和樺樹的過敏計劃，這些計劃預計將於今年晚些時候更新。

As previously reported, itepekimab, our interleukin-33 antibody, evaluated for COPD and former smokers regardless of eosinophil levels, met the primary endpoint in only one of two replicate studies. Together with Sanofi, we continue to evaluate the data to inform next steps for potential future COPD development. Itepekimab development continues in other respiratory diseases. Most notably, the ongoing Phase 3 studies in chronic rhinosinusitis with nasal polyps as well as Phase 2 proof-of-concept studies in less validated clinical settings.

如前所述，我們的白細胞介素 33 抗體 itepekimab 對 COPD 和既往吸煙者進行了評估，無論嗜酸性粒細胞水平如何，在兩項重複研究中僅一項達到了主要終點。我們與賽諾菲一起繼續評估數據，為未來潛在的 COPD 發展提供指導。Itepekimab 在其他呼吸系統疾病領域的開發仍在繼續。最值得注意的是，目前正在進行的針對伴有鼻息肉的慢性鼻竇炎的 3 期研究以及在驗證較少的臨床環境中進行的 2 期概念驗證研究。

Turning to our oncology efforts. In high-risk adjuvant CSCC where Libtayo became the first immunotherapy to demonstrate a benefit where others had failed, the FDA accepted our supplemental BLA with priority review and assigned a PDUFA date in October of this year. This dataset presented earlier this year at ASCO and published in the New England Journal of Medicine reinforces our belief that Libtayo provides a best-in-class foundation from combination therapies with our other oncology assets.

談談我們的腫瘤學努力。在高風險輔助 CSCC 中，Libtayo 成為第一個在其他療法失敗的情況下證明有益的免疫療法，FDA 接受了我們的補充 BLA 並進行了優先審查，並於今年 10 月指定了 PDUFA 日期。該數據集於今年早些時候在 ASCO 上展示並發表在《新英格蘭醫學雜誌》上，這進一步強化了我們的信念：Libtayo 與我們的其他腫瘤學資產的聯合療法提供了一流的基礎。

And in this context, Libtayo is being tested in combination with fianlimab, our LAG-3 antibody, in the pivotal trial in first-line advanced melanoma, a setting in which this combination has generated compelling preliminary efficacy data when compared cross-trial to PD-1 monotherapy.

在此背景下，Libtayo 正在與我們的 LAG-3 抗體 fianlimab 聯合進行測試，這是一線晚期黑色素瘤的關鍵試驗，與 PD-1 單一療法進行交叉試驗相比，這種組合已產生令人信服的初步療效數據。

The primary endpoint for this study is progression-free survival and KEYTRUDA monotherapy as a control. Enrollment for the PFS cohort was completed in January as expected, but results are now anticipated in late 2025 or early 2026, as the blinded PFS event rate accrual has slowed in recent months.

本研究的主要終點是無惡化存活期並以 KEYTRUDA 單藥治療作為對照。PFS 隊列的招募已於 1 月按預期完成，但由於近幾個月盲法 PFS 事件發生率的增加有所放緩，因此預計結果將在 2025 年末或 2026 年初公佈。

Turning to our CD3 bispecifics. Lynozyfic, our BCMA by CD3 bispecific has now been approved in the United States for relapsed/refractory multiple myeloma. Lynozyfic's label is differentiated compared to other FDA-approved BCMA bispecifics with nearly double the complete response rates. Lynozyfic's label also includes a more favorable profile to cytokine release syndrome, shorter required hospitalization period, and a more convenient dosing regimen with longer intervals between doses for those patients that achieved at least very good partial responses after 24 weeks on therapy.

轉向我們的 CD3 雙特異性抗體。我們的 BCMA by CD3 雙特異性抗體 Lynozyfic 現已在美國獲得批准，用於治療復發/難治性多發性骨髓瘤。Lynozyfic 的標籤與其他 FDA 批准的 BCMA 雙特異性抗體相比有所差異，其完全緩解率幾乎提高了一倍。Lynozyfic 的標籤還包括對細胞激素釋放症候群更有利的概況、更短的住院時間，以及更方便的給藥方案，對於那些在 24 週的治療後達到至少非常好的部分反應的患者，劑量間隔更長。

More broadly, we believe Lynozyfic has the potential to become the backbone for therapeutic approaches across the myeloma treatment landscape. That is from premalignant settings through advanced disease, using both monotherapy and limited novel combination approaches. I've already summarized how Lynozyfic may have best-in-class activity in the most advanced myeloma patients where it was recently approved.

更廣泛地說，我們相信 Lynozyfic 有潛力成為整個骨髓瘤治療領域治療方法的支柱。這是從癌前病變到晚期疾病，採用單一療法和有限的新型組合療法。我已經總結了 Lynozyfic 如何能夠在最近獲得批准的最晚期骨髓瘤患者中發揮最佳活性。

Moving to the premalignant settings, starting with high-risk smoldering myeloma. On the initial cohort of 19 evaluable patients with Lynozyfic monotherapy, we observed 100% overall response rate with a favorable safety profile.

轉向癌前病變，從高風險冒煙型骨髓瘤開始。在最初接受 Lynozyfic 單藥治療的 19 名可評估患者中，我們觀察到整體反應率為 100%，且安全性良好。

Among the first six patients achieving one year of follow-up, five were in complete response and all six were MRD negative. In this regard and recognizing the limitations of cross-trial comparisons, DARZALEX was recently approved in the EU as a monotherapy with a complete response rate of only 8.8% in a similar setting. Based on this early data in high-risk smoldering myeloma patients, which suggests that Lynozyfic could prevent progression to malignant disease, we plan to initiate a Phase 3 head-to-head study against DARZALEX in the fourth quarter.

在前六名獲得一年追蹤的患者中，五名達到完全緩解，六名患者均為 MRD 陰性。在這方面，認識到交叉試驗比較的局限性，DARZALEX 最近在歐盟獲得批准作為單一療法，在類似環境下的完全緩解率僅為 8.8%。根據高風險冒煙型骨髓瘤患者的早期數據，這表明 Lynozyfic 可以防止病情發展為惡性疾病，我們計劃在第四季度啟動針對 DARZALEX 的 3 期頭對頭研究。

In another premalignant plasma cell disorder, light chain amyloidosis, exploratory data with linozyfic monotherapy showed that the average light chain levels were normalized by two weeks in the first 11 treated patients all of whom have failed prior therapies.

在另一種癌前漿細胞疾病輕鏈澱粉樣變性中，使用林可替尼單一療法的探索性數據顯示，在前 11 名接受治療的患者中，平均輕鏈水平在兩週內恢復正常，這些患者之前的治療均失敗了。

For context, while noting the limitations across comparisons, patients taking a 4-drug combination standard containing Darzalex as one of the four components in previously untreated light chain amyloidosis, it took more than five months for patients who approach without achieving normalization.

就背景而言，雖然注意到比較的局限性，但對於先前未接受治療的輕鏈澱粉樣變性患者，服用含有 Darzalex 的 4 種藥物組合標準作為四種成分之一，對於未達到正常化的患者，需要花費五個多月的時間。

Now moving to the second line multiple myeloma setting for patients who have failed or progressed after the initial triplet or quadruple regimen, usually containing Darzalex and two to three other agents. We presented data at ASCO earlier this year showing that linefit combined with carfolzumab (inaudible) strong responses in relapsed or refractory myeloma patients, demonstrating a 90% response rate with 76% complete response rate. We think this novel doublet regimen could potentially offer an important new treatment option for second-line patients who have failed their CD38 containing frontline regimens and anticipate initiating a registrational randomized Phase 3 trial in the fourth quarter of this year to evaluate the Lynozyfic (inaudible) doublet against standard of care in the second-line setting. Importantly, across all of these settings, no new or unexpected safety signals have emerged for Lynozyfic. Based on these collective data sets suggesting that Lynozyfic may have unprecedented ability to address myeloma and premalignant disease and become a new backbone for myeloma therapies, we anticipate conducting as many as 10 registrational trials for Lynozyfic including a broad registrational program in frontline myeloma for transplant eligible and ineligible patients.

目前，該療法已轉為二線治療，適用於初始三聯療法治療失敗或病情進展的多發性骨髓瘤患者，通常包含 Darzalex 和兩至三種其他藥物。我們在今年稍早的 ASCO 上展示了數據，顯示 linefit 與 carfolzumab（聽不清）相結合對復發或難治性骨髓瘤患者有強烈的反應，反應率為 90%，完全反應率為 76%。我們認為，這種新型雙聯療法可能為那些使用含 CD38 的一線療法治療失敗的二線患者提供一種重要的新治療選擇，並預計將於今年第四季度啟動一項註冊隨機 3 期試驗，以評估 Lynozyfic（聽不清）雙聯療法與二線治療標準相比的效果。重要的是，在所有這些環境中，Lynozyfic 都沒有出現新的或意外的安全訊號。基於這些集體數據集，Lynozyfic 可能具有前所未有的治療骨髓瘤和癌前疾病的能力，並成為骨髓瘤治療的新支柱，我們預計將為 Lynozyfic 開展多達 10 項註冊試驗，包括針對移植合格和不合格患者的一線骨髓瘤的廣泛註冊計劃。

On to odronextamab, our CD20xCD3 bispecific which, once again, as with Lynozyfic, we are looking to advance odronextamab into earlier lymphoma settings, and enrollment in these trials is proceeding expeditiously. In first-line follicular lymphoma the Phase 3 Olympia odronextamab monotherapy study has already completed enrollment. As previously reported, in an FDA-mandated lead-in cohort odronextamab monotherapy demonstrated an encouraging 100% complete response rate in the first 12 evaluable patients with a favorable safety profile. For reference, standard of care rituximab plus CHOP and rituximab plus (inaudible) are reported to demonstrate complete responses of approximately 65% on average in these populations.

說到 odronextamab，我們的 CD20xCD3 雙特異性抗體，與 Lynozyfic 一樣，我們希望將 odronextamab 推進到早期淋巴瘤治療領域，這些試驗的招募工作正在迅速進行。在濾泡性淋巴瘤的一線治療中，3 期 Olympia odronextamab 單藥治療研究已經完成招募。如前所述，在 FDA 強制要求的引導組中，odronextamab 單藥療法在前 12 名可評估患者中表現出令人鼓舞的 100% 完全緩解率，且安全性良好。作為參考，據報道，標準治療利妥昔單抗加 CHOP 和利妥昔單抗加（聽不清）在這些人群中平均表現出約 65% 的完全緩解率。

In addition to the potential improved rate of complete responses, we believe a monotherapy chemo-free approach could also provide a favorable safety profile in comparison to these other chemo-based regimens. In first-line diffuse large B-cell lymphoma, the Phase 3 OLYMPIA III study comparing odronextamab plus CHOP or OCHOP to rituximab plus CHOP to the current standard of care has complete enrollment in the FDA mandate leading cohorts. In the first 13 patients treated at the intended odronextamab dose O CHOP demonstrated once again a 100% complete response rate with a favorable safety profile for reference R-CHOP in first-line DLBCL has historically demonstrated a complete response rate of about 75% in the setting.

除了可能提高完全緩解率之外，我們相信，與其他基於化療的方案相比，單一療法無化療方法也能提供良好的安全性。在一線瀰漫大 B 細胞淋巴瘤中，將 odronextamab 加 CHOP 或 OCHOP 與利妥昔單抗加 CHOP 與目前標準治療進行比較的 3 期 OLYMPIA III 研究已在 FDA 授權的領先隊列中完成招募。在以預期的 odronextamab 劑量治療的前 13 名患者中，CHOP 再次顯示出 100% 的完全緩解率，並且具有良好的安全性，作為參考，R-CHOP 在一線 DLBCL 中的歷史顯示完全緩解率約為 75%。

Both Linozyfic and odronextamab represent potential significant treatment advances in their respective disease areas, and we look forward to rapidly advancing these programs. We plan to present to publish many of these early data sets over the coming months.

Linozyfic 和 odronextamab 都代表了各自疾病領域潛在的重大治療進展，我們期待快速推進這些計畫。我們計劃在未來幾個月內發布許多這些早期數據集。

Turning now to thrombosis. Our Factor XI program continues to advance rapidly. The first pivotal study in postoperative venous thromboembolism following total knee replacement surgery, evaluating our Factor XI catalytic domain antibody versus apixaban and enoxaparin has begun enrollment we anticipate data from the short duration study in 2027, which could support a fast-to-market regulatory pathway. Additional pivotal studies in thrombosis indications are set to launch by year-end with more pivotal study starts expected early next year.

現在來談談血栓形成。我們的 XI 因子計劃繼續快速推進。首個針對全膝關節置換術後靜脈血栓栓塞症的關鍵性研究已開始招募，該研究評估了我們的 XI 因子催化域抗體與阿哌沙班和依諾肝素的療效，我們預計這項短期研究的數據將於 2027 年獲得，這可以支持快速上市的監管途徑。更多針對血栓症適應症的關鍵研究預計將於年底啟動，更多關鍵研究預計將於明年初啟動。

Moving now to our obesity efforts. Our recently in-licensed GLP-1 GIP receptor agonist positions us well to expand into the growing obesity market. Regeneron has multiple opportunities in this large and growing therapeutic area including GLP-1 GIP receptor agonist monotherapy, a longer acting agent in preclinical development as well as approaches to enhance the quality of GLP-1-based weight loss through combination therapies with lean mass bearing agents. We also see an opportunity to address common obesity comorbidities with novel combinations. Results from our ongoing Phase 2 COURAGE study which is a valuing combination of trevogrumab, a myostatin antibody with and without garetosmab an active (inaudible) antibody and semaglutide confirmed the potential to enhance GLP-1 mediated weight loss while preserving lean mass.

現在開始討論我們的肥胖問題。我們最近獲得許可的 GLP-1 GIP 受體激動劑使我們能夠很好地擴展到不斷增長的肥胖市場。再生元在這個龐大且不斷增長的治療領域擁有多種機會，包括 GLP-1 GIP 受體激動劑單一療法、處於臨床前開發的長效藥物以及通過與瘦體重承受劑聯合療法來提高基於 GLP-1 的減肥質量的方法。我們也看到了透過新的組合解決常見肥胖合併症的機會。我們正在進行的 2 期 COURAGE 研究的結果證實了 trevogrumab（一種肌肉生長抑制素抗體）與或不與 garetosmab（一種活性（聽不清）抗體）和 semaglutide 的組合具有增強 GLP-1 介導的減肥效果同時保持瘦體重的潛力。

At the interim analysis, our trial confirmed that approximately 35% of semaglutide induced weight loss was due to lean mass loss. An average loss of 7 to 8 pounds of lean mass per patient. Once again highlighting a well-documented concern associated with this therapeutic class. Combining semaglutide with our muscle preserving antibodies reduced lean mass loss by 50% to 80% and while also increasing mass loss at the 26-week time point. The combination of semaglutide with trevogrumab, was generally well tolerated.

在中期分析中，我們的試驗證實，約 35% 的司美格魯肽引起的體重減輕是由於瘦體重減輕造成的。每位患者平均損失7至8磅瘦體重。再次強調了與該治療類別相關的有據可查的擔憂。將司美格魯肽與我們的肌肉保護抗體結合，可減少 50% 至 80% 的瘦體重損失，同時在第 26 週時間點增加體重損失。索馬魯肽與特雷沃格魯單抗的組合通常耐受性良好。

The triplet combination of semaglutide with both antibodies had a higher rate of discontinuations due to tolerability issues and other adverse events, consistent with the safety profile previously observed with garetosmab monotherapy in other disease settings.

由於耐受性問題和其他不良事件，索馬魯肽與兩種抗體的三聯療法的停藥率較高，這與先前在其他疾病環境中觀察到的 Garetosmab 單藥療法的安全性一致。

Emerging data from across this class further validate our approach in this area. Final 26-week efficacy and safety results were consistent with the interim data, and we'll be presenting the late-breaking session at the 61st Annual Meeting of the European Association for the Study of Diabetes in September 2025.

來自該類別的新數據進一步驗證了我們在這一領域的方法。最終 26 週的療效和安全性結果與中期數據一致，我們將在 2025 年 9 月舉行的歐洲糖尿病研究協會第 61 屆年會上展示最新的研究成果。

Concluding with our Regeneron Genetic Medicines pipeline. Our C5 siRNA and antibody combination has shown robust efficacy in patients with Paroxysmal Nocturnal Hemoglobinuria or PNH. These data and PNH support our confidence in this regimen's potential to improve outcomes and reduce treatment burden in generalized myasthenia gravis, where pivotal results for an ongoing Phase 3 study are expected in the third quarter. This study will provide insights into the activity of both the C5 siRNA monotherapy in C5 siRNA antibody combinations. Our ongoing Phase 3 studies in geographic (inaudible) and PNH as well as preclinical efforts in this space further underscore our commitment to advancing this program.

最後以我們的再生元基因藥物管道作為結束。我們的 C5 siRNA 和抗體組合已對陣發性睡眠性血紅蛋白尿症 (PNH) 患者表現出強大的療效。這些數據和 PNH 支持了我們對這種療法改善全身性重症肌無力療效和減輕治療負擔的潛力的信心，正在進行的 3 期研究的關鍵結果預計將在第三季度公佈。這項研究將深入了解 C5 siRNA 單一療法和 C5 siRNA 抗體組合的活性。我們正在進行的地理（聽不清楚）和 PNH 的 3 期研究以及該領域的臨床前工作進一步強調了我們推進該計劃的承諾。

In addition, we also continue to advance our genetic medicines programs in MASH, neurodegenerative disorders and hearing loss and expect to provide updates over the next few months. In summary, Regeneron continues to lead in scientific innovation, delivering results that redefine possibilities in medicine. Our R&D expertise has enabled us to build one of the most dynamic and promising pipelines in the industry and we look forward to several important milestones in the coming months. With that, let me turn it over to Marion.

此外，我們還將繼續推動 MASH、神經退化性疾病和聽力損失的基因藥物項目，並期望在未來幾個月內提供最新進展。總而言之，再生元持續引領科學創新，取得重新定義醫學可能性的成果。我們的研發專業知識使我們能夠建立業內最具活力和前景的管道之一，我們期待在未來幾個月內取得幾個重要的里程碑。說完這些，讓我把話題交給馬里恩。

Thank you, George. Our second quarter performance highlights the strength and resiliency of Regeneron's commercial portfolio, demonstrating our ability to deliver important medicines to patients. We are well positioned to drive growth, fully realizing the potential of our leading brands and capitalizing on emerging opportunities.

謝謝你，喬治。我們第二季的業績凸顯了再生元商業產品組合的實力和彈性，證明了我們為患者提供重要藥物的能力。我們已做好充分準備來推動成長，充分發揮我們領先品牌的潛力並利用新興機會。

Recent launches include Lynozyfic, our first hematology product in the US as well as two Dupixent dermatology launches in chronic pontemias urticaria and bolus pemphigoid further expanding its therapeutic reach. Our robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients.

最近推出的產品包括我們在美國推出的首款血液學產品 Lynozyfic，以及兩款分別用於治療慢性蕁麻疹和大皰性類天皰瘡的 Dupixent 皮膚病學產品，進一步擴大了其治療範圍。我們強大的產品線也為更多患者帶來變革性治療提供了巨大的機會。

Starting with EYLEA HD and EYLEA. In the second quarter, total combined US net sales were $1.15 billion, maintaining our leading position in the anti-VEGF category. Notably, EYLEA HD US net sales grew to $393 million, driven by strong unit demand, which increased 16% sequentially, making EYLEA HD the fastest-growing innovative brand in the category.

從 EYLEA HD 和 EYLEA 開始。第二季度，美國總淨銷售額為 11.5 億美元，維持了我們在抗 VEGF 類別中的領先地位。值得注意的是，受強勁單位需求的推動，EYLEA HD 美國淨銷售額增長至 3.93 億美元，環比增長 16%，使 EYLEA HD 成為該類別中增長最快的創新品牌。

EYLEA HD is a solid foundation for future growth and now contributes 1/3 of total combined US net sales of our retina products. Looking ahead, we expect stable demand and total potential inflection pending FDA approval of enhancement to EYLEA HD's profile.

EYLEA HD 為未來的成長奠定了堅實的基礎，目前占我們視網膜產品美國總淨銷售額的 1/3。展望未來，我們預計需求將保持穩定，整體潛在變化將等待 FDA 批准對 EYLEA HD 進行增強。

EYLEA's second quarter US net sales were $754 million reflecting competitive dynamics from both branded and bio-similar competition as well as the ongoing conversion of patients to EYLEA HD. EYLEA unit demand declined 10% sequentially, and we anticipate comparable demand decline in the second half of the year. Retina practices continue to report a negative impact on the branded anti-VEGF category due to ongoing funding gaps at not-for-profit patient assistance foundations that provide copay support for eligible patients with retina diseases.

EYLEA 第二季度美國淨銷售額為 7.54 億美元，反映了品牌藥和生物仿製藥的競爭動態以及患者向 EYLEA HD 的持續轉變。EYLEA 單位需求將較上季下降 10%，我們預計下半年需求也會出現相應下降。由於為符合條件的視網膜疾病患者提供共付額支持的非營利性患者援助基金會持續存在資金缺口，視網膜治療持續對品牌抗 VEGF 類別產生負面影響。

Next to Dupixent. In the second quarter, global net sales were $4.3 billion and grew 21% on a constant currency basis compared to the prior year. This growth was driven by broad demand across existing and recently launched indications, geographies and age groups. In the US, Dupixent net sales were $3.2 billion, representing 23% year-over-year growth and continuing Dupixent's strong performance and market-leading position. Dupixent is a leader in new-to-brand and total prescriptions for 7 of its FDA-approved indications with our recently launched CSU indication being the only exception.

在 Dupixent 旁邊。第二季度，全球淨銷售額為 43 億美元，以固定匯率計算比上年增長 21%。這一增長是由現有和新推出的適應症、地理和年齡組的廣泛需求所推動的。在美國，Dupixent 淨銷售額為 32 億美元，年成長 23%，延續了 Dupixent 強勁的業績和市場領先地位。Dupixent 在 FDA 批准的 7 種適應症的新品牌和總處方方面處於領先地位，我們最近推出的 CSU 適應症是唯一的例外。

In Atopic Dermatitis, Dupixent continues to strengthen its position as a standard of care. Competitor promotional spend has further accelerated overall market growth. Dupixent remains the primary beneficiary of this expansion. Recent launches in chronic spontaneous urticaria and Bullous pemphigoid are off to a fast start, as CSU launch has gained significant traction with both dermatologists and allergists who are actively prescribing Dupixent and embracing it as a trusted and effective treatment option. The BP launch in late June has also provided another opportunity for Dupixent as the first and only FDA-approved treatment for this debilitating disease.

在異位性皮膚炎領域，Dupixent 繼續加強其作為治療標準的地位。競爭對手的促銷支出進一步加速了整體市場的成長。Dupixent 仍然是此次擴張的主要受益者。最近推出的用於治療慢性自發性蕁麻疹和大皰性類天皰瘡的藥物取得了快速進展，因為 CSU 的推出已經引起了皮膚科醫生和過敏症專科醫生的極大關注，他們積極開具 Dupixent 處方並將其視為一種值得信賴且有效的治療選擇。6 月底 BP 的上市也為 Dupixent 提供了另一個機會，使其成為 FDA 批准的首個也是唯一一個治療這種衰弱性疾病的藥物。

Early launch indicators have been positive with Dupixent as a critical therapeutic option for this previously underserved patient population. Dupixent's respiratory indications, including COPD asthma and nasal polyps continue to drive growth. The COPD launch is progressing very well with rapid physician uptake.

早期上市指標顯示 Dupixent 是這一先前未充分服務的患者群體的關鍵治療選擇，具有積極意義。Dupixent 的呼吸系統適應症，包括 COPD 氣喘和鼻息肉，繼續推動成長。隨著醫生的快速接受，COPD 的推廣進展順利。

Turning to oncology and hematology. In the second quarter, Libtayo delivered global net sales of $377 million growing 25% on a constant currency basis compared to the prior year. In the US, Libtayo net sales grew 36% and year-over-year to $248 million, driven by growth across the non-melanoma skin and lung cancer indications. The quarter was also favorably impacted by the timing of customer shipments by approximately $20 million, which we expect to adversely impact third quarter US net product sales.

轉向腫瘤學和血液學。第二季度，Libtayo 全球淨銷售額達 3.77 億美元，以固定匯率計算比上年增長 25%。在美國，Libtayo 淨銷售額年增 36%，達到 2.48 億美元，這得益於非黑色素瘤皮膚和肺癌適應症的成長。本季也受到客戶出貨時間約 2,000 萬美元的正面影響，我們預計這將對第三季美國淨產品銷售額產生不利影響。

We continue to see robust demand and market leadership Libtayo in non-melanoma skin cancer. We're encouraged by strong key opinion leader interest in the clinical results for our adjuvant CCC program. Regulatory applications were recently accepted in both the US and EU and preparations are underway for a potential launch in the US later this year and in Europe in 2026.

我們繼續看到 Libtayo 在非黑色素瘤皮膚癌領域的強勁需求和市場領導地位。關鍵意見領袖對我們的輔助 CCC 計劃的臨床結果表現出濃厚的興趣，這讓我們感到鼓舞。美國和歐盟最近都接受了監管申請，目前正在為今年稍後在美國和 2026 年在歐洲推出做準備。

If approved, Libtayo has the potential to help more than 10,000 patients in the US and EU in this setting.

如果獲得批准，Libtayo 有可能幫助美國和歐盟的 10,000 多名患者。

In lung cancer, Libtayo is steadily increasing new patient share in (inaudible) with more physicians prescribing Libtayo as a preferred treatment option for their patients and solidifying its position as the #2 most prescribed I/O treatment in newly diagnosed patients. Outside the US Libtayo net sales reached $129 million, growing 8% year-over-year on a constant currency basis, supported by ongoing inches and sustained demand in international markets.

在肺癌領域，Libtayo 正在穩步增加（聽不清楚）新患者的份額，越來越多的醫生將 Libtayo 作為患者的首選治療方案，並鞏固了其作為新診斷患者中第二大最常用的 I/O 治療方法的地位。在美國以外，Libtayo 的淨銷售額達到 1.29 億美元，以固定匯率計算年增 8%，這得益於國際市場的持續成長和持續的需求。

Now to Lynozyfic, which was FDA approved in July in relapsed refractory multiple myeloma, marking a significant milestone for Regeneron. Since then, we've made early launch progress. Importantly Lynozyfic already added to NCCN treatment guidelines as a preferred product on par with other bispecifics in this class. Key opinion leaders recognize Lynozyfic's potential to be best-in-class BCMA bispecific based on its impressive clinical efficacy, safety and convenience response adaptive dosing. At this stage, we expect modest revenue contributions in the second half of 2025 as physicians must satisfy REMS requirements before administering Lynozyfic and formulary and pathway decisions need to be made.

現在來談談 Lynozyfic，該藥物於 7 月獲得 FDA 批准用於治療復發難治性多發性骨髓瘤，這對 Regeneron 來說是一個重要的里程碑。自那時起，我們已取得早期發布進展。重要的是，Lynozyfic 已被添加到 NCCN 治療指南中，成為與同類其他雙特異性藥物相同的首選產品。關鍵意見領袖認為 Lynozyfic 具有成為同類最佳 BCMA 雙特異性藥物的潛力，因為它具有令人印象深刻的臨床療效、安全性和便捷的自適應劑量。在現階段，我們預計 2025 年下半年的收入貢獻將適度，因為醫生在使用 Lynozyfic 之前必須滿足 REMS 要求，並且需要做出處方集和治療途徑決策。

As George highlighted, Regeneron is advancing Lynozyfic into earlier lines of therapy through our differentiated development program, aiming to establish Lynozyfic as a leading agent in the rapidly growing $30 billion market for multiple myeloma and precursor conditions.

正如喬治所強調的，再生元正在透過我們的差異化開發計劃將 Lynozyfic 推進到早期治療領域，旨在使 Lynozyfic 成為快速增長的 300 億美元多發性骨髓瘤和前體疾病市場的領先藥物。

In summary, the quarter has been defined by growth across EYLEA HD, Dupixent and Libtayo, as well as important progress in several ones, including Lynozyfic. Our commercial portfolio is well positioned to capitalize on many near-term growth opportunities, enabling us to deliver treatments to more patients. And with that, I'll turn the call to Chris.

總而言之，本季的特點是 EYLEA HD、Dupixent 和 Libtayo 的成長，以及包括 Lynozyfic 在內的幾個產品的重要進展。我們的商業組合能夠充分利用許多近期的成長機會，使我們能夠為更多患者提供治療。說完這些，我就把電話轉給克里斯。

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis unless otherwise noted. Regeneron's second quarter results demonstrate the strength of our commercial portfolio which enables us to continue investing in our robust pipeline and returning capital to shareholders.

謝謝你，瑪麗安。除非另有說明，我今天對 Regeneron 財務業績和前景的評論將基於非 GAAP 基礎。Regeneron 的第二季業績證明了我們商業組合的實力，這使我們能夠繼續投資於我們強大的產品線並向股東返還資本。

Second quarter 2025 total revenues of $3.7 billion grew 4% compared to the prior year, reflecting higher Sanofi collaboration revenue, primarily driven by Dupixent, higher US net sales of EYLEA HD and growth in global net sales of Libtayo. Second quarter diluted net income per share grew 12% from the prior year to $12.89 on net income of $1.4 billion.

2025 年第二季總營收為 37 億美元，較上年成長 4%，反映了賽諾菲合作收入的增加，主要受 Dupixent 的推動，EYLEA HD 美國淨銷售額的增加以及 Libtayo 全球淨銷售額的成長。第二季每股攤薄淨收益較上年同期成長 12% 至 12.89 美元，淨收益為 14 億美元。

Beginning with the Sanofi collaboration, revenues were approximately $1.4 billion, of which $1.3 billion related to our share of collaboration profits. Regeneron's share of profits grew 30% versus the prior year driven by volume through Dupixent and improving collaboration margins. The Sanofi development (inaudible) was approximately $1.2 billion at the end of the second quarter, reflecting a reduction of approximately $430 million since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year.

從與賽諾菲的合作開始，營收約為 14 億美元，其中 13 億美元與我們的合作利潤份額有關。由於 Dupixent 的銷售成長和合作利潤率的提高，Regeneron 的利潤份額較上年增長了 30%。賽諾菲發展（聽不清楚）在第二季末約為 12 億美元，自年初以來減少了約 4.3 億美元。我們仍然預計餘額將在年底前全額償還。

Moving to Bayer. Second quarter net sales of EYLEA and EYLEA 8 mg outside the US were $978 million, up 4% versus the prior year on a constant currency basis, inclusive of $242 million EYLEA 8 mg sales. Total Bayer collaboration revenue grew 11% to $415 million, of which $383 million related to our share of net profits outside the US Other revenue in the second quarter was $184 million.

轉投拜耳。第二季度，EYLEA 和 EYLEA 8 毫克在美國以外的淨銷售額為 9.78 億美元，以固定匯率計算比上年增長 4%，其中包括 2.42 億美元的 EYLEA 8 毫克銷售額。拜耳合作總收入成長 11% 至 4.15 億美元，其中 3.83 億美元與我們在美國以外的淨利潤份額有關；第二季度的其他收入為 1.84 億美元。

This included $118 million of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from (inaudible) and higher royalty income from Alaris.

其中包括 1.18 億美元的利潤分成和與許可協議相關的特許權使用費，比前一年增長了 70%。這一增長是由我們從（聽不清楚）獲得的利潤份額的增長以及來自 Alaris 的更高的特許權使用費收入所推動的。

Now to our operating expenses. R&D expense was $1.3 billion in the second quarter reflecting continued investments to support Regeneron's innovative mid- to late-stage pipeline, including our obesity, hematology and thrombosis efforts. Second quarter SG&A was $542 million down 19% from the prior year, decline was driven by lower general and administrative expenses. Second quarter 2025 gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects ongoing investments to support our manufacturing operations and higher inventory write-offs in the second quarter of 2025.

現在談談我們的營運費用。第二季的研發費用為 13 億美元，反映了對再生元創新中後期研發管線的持續投資，包括我們的肥胖、血液學和血栓形成研究。第二季銷售、一般及行政開支為 5.42 億美元，較上年下降 19%，下降是由於一般及行政開支下降所致。2025 年第二季淨產品銷售毛利率為 86%。與去年相比，毛利率較低反映了我們為支持製造業務而進行的持續投資以及 2025 年第二季更高的庫存註銷。

Our effective tax rate in the second quarter was 8.3% inclusive of a favorable settlement of an IRS audit, which lowered our tax rate by approximately 4 percentage points.

我們第二季的有效稅率為 8.3%，其中包括對美國國稅局審計的有利和解，這使我們的稅率降低了約 4 個百分點。

Regeneron generated $1.7 billion in free cash flow through the first 6 months of 2025 and ended the quarter with cash and marketable securities of $17.5 billion and debt of approximately $2.7 billion. We repurchased approximately $1.1 billion worth of our shares in the second quarter and approximately $2.2 billion so far in 2025, resulting in a net redundant in our common shares outstanding of 3.2 million shares from the end of 2024. With approximately $2.8 billion still available for share repurchases as of June 30, we remain opportunistic buyers of our shares. We have made some updates to our 2025 financial guidance changes in guidance ranges for SG&A, R&D and COCM expenses result in a combined net decrease of $125 million at the respective midpoints partially offset by slightly lower gross margin guidance. Importantly, the change to our gross margin guidance is unrelated to the recent tariff announcements.

2025 年前 6 個月，Regeneron 產生了 17 億美元的自由現金流，本季末的現金和有價證券為 175 億美元，債務約為 27 億美元。我們在第二季回購了價值約 11 億美元的股票，2025 年迄今回購了價值約 22 億美元的股票，導致從 2024 年底起，我們的流通普通股淨冗餘量為 320 萬股。截至 6 月 30 日，仍有約 28 億美元可用於股票回購，我們仍是股票的機會主義買家。我們對 2025 年財務指導進行了一些更新，對銷售、一般及行政費用、研發費用和主要經營成本費用的指導範圍進行了修改，導致相應中點的淨減少總額為 1.25 億美元，但毛利率指導略有下降，部分抵消了這一影響。重要的是，我們毛利率指引的變化與最近的關稅公告無關。

While many details from the US EU trade agreement have yet to emerge, including winning tariff may go into effect, we do not currently expect a 15% tariff on non-generic pharmaceutical products to have a material impact on our financial results in 2025. As we gain clarity on important details from the trade agreement and other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term.

雖然美國歐盟貿易協定的許多細節尚未公佈，包括可能生效的中標關稅，但我們目前預計，對非仿製藥產品徵收 15% 的關稅不會對我們 2025 年的財務業績產生重大影響。隨著我們逐漸明確貿易協定和其他潛在關稅的重要細節，我們將能夠更好地評估關稅在 2026 年及更長時期內的財務影響。

Finally, while we are continuing to evaluate the impact of recently enacted tax legislation, we currently anticipate limited impact to our effective tax rate in the long term and continue to expect this rate to trend towards the mid-teens over time. A full summary of our latest guidance can be found in our press release issued earlier this morning. In conclusion, Regeneron's second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver break through for patients and long-term value for shareholders. With that, I'll pass the call back to Ryan.

最後，雖然我們正在繼續評估最近頒布的稅收立法的影響，但我們目前預計，從長遠來看，其對我們的有效稅率的影響有限，並預計隨著時間的推移，這一稅率將趨向於十幾歲的水平。我們最新指南的完整摘要可在我們今天早上發布的新聞稿中找到。總之，再生元第二季的業績證明了我們業務的實力，並使我們能夠繼續投資於我們的差異化產品線，為患者帶來突破，為股東帶來長期價值。說完，我會把電話轉回給瑞安。

Before we move to Q&A, I just wanted to make one correction on our remark that Chris made. We anticipate fully reimbursing the Sanofi development balance by the end of 2026, not this year. End of 2026. With that, let's move to Q&A to ensure we are able to address as many questions as possible. We will answer one question from each call before moving to the next.

在我們進入問答環節之前，我只想對克里斯的評論做一個糾正。我們預計將在 2026 年底之前（而不是今年）全額償還賽諾菲開發餘額。2026年底。接下來，讓我們進入問答環節，以確保我們能夠解答盡可能多的問題。在轉到下一個電話之前，我們將回答每個電話中的一個問題。

Shannon, can we go to the first question, please?

香農，我們可以進入第一個問題嗎？

(Operator Instructions)

（操作員指示）

Tim Anderson, Bank of America.

美國銀行的蒂姆·安德森。

Good Q2 results, but I have a policy question that's on MSN and the (inaudible) letters that were sent out. Three of those letters had the CEO names crossed out, replaced with first names that were kind of penciled over. That was Lilly, Pfizer and Regeneron, and it makes me wonder, is there a closer relationship between those CEOs and Trump? I know Lilly and Pfizer have been the (inaudible) a lot to influence policy. So my question is, Len, have you been down there frequently as well?

第二季的業績不錯，但我對 MSN 和發出的（聽不清楚）信件中的政策有一個疑問。其中三封信中的執行長名字被劃掉，取而代之的是一些用鉛筆寫的名字。那是禮來、輝瑞和再生元，這讓我想知道，這些執行長與川普之間是否存在更密切的關係？我知道禮來公司和輝瑞公司對政策產生了很大的影響。所以我的問題是，Len，你也常去那裡嗎？

I asked because of common assumption, is that MSN might play out through a CMMI demo product. EYLEA is a big part -- the drug. Could that get wrapped into it or not because there's a biosimilar. So some visibility. Any (inaudible) on any of this would be appreciated.

我之所以問這個問題，是因為一個普遍的假設是，MSN 可能會透過 CMMI 演示產品發揮作用。EYLEA 是藥物的重要組成部分。由於存在生物相似藥，因此是否可以將其納入其中？因此有一定的可見性。任何（聽不清楚）對此內容的意見都將不勝感激。

Yes. Thanks. I've been down there frequently. I think President probably knows Regeneron and my first name, given that it was Regeneron's cocktail for COVID that may have saved his life. Beyond that, I don't have any great insights to the policies.

是的。謝謝。我常去那裡。我認為總統可能知道 Regeneron 和我的名字，因為 Regeneron 的 COVID 雞尾酒療法可能挽救了他的生命。除此之外，我對這些政策沒有什麼深刻的見解。

I have been and the company has been outspoken that we agree with the President that the Europeans are not paying their fair share of innovation and some way that needs to change. It's complicated and it does have to be done in a trade and policy level because it can't be done at an individual company level. It's very difficult, but we certainly agree that it's not right. The Americans, American consumers should not be paying for all of the innovation. The solution is simply not to lower cost -- prices in the US without some calibrating in Europe because then there'll be no innovation. But the answer to your question is I don't have any unique insight because my first name was used.

我和我的公司一直直言不諱地表示，我們同意總統的觀點，即歐洲人沒有為創新付出應有的份額，這種情況需要改變。這很複雜，必須在貿易和政策層面上進行，因為無法在單一公司層面上完成。這非常困難，但我們當然同意這是不對的。美國人、美國消費者不該為所有的創新買單。解決方案很簡單，不要降低成本——在美國降低價格而不對歐洲進行一些調整，因為那樣就不會有創新。但對於你的問題，答案是，我並沒有任何獨特的見解，因為我的名字被使用。

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

請讓我們進入下一個問題，香農。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

So there's a great quarter-over-quarter rebound in EYLEA HD. So curious to hear what would attribute that to. And regarding the (inaudible) site inspection issue, can you provide additional color on the nature of the issue? And if there's present for how long it might take to resolve it or how long the potential HD approvals will be pushed back by?

因此，EYLEA HD 的季度環比反彈強勁。非常好奇想知道這是什麼原因造成的。關於（聽不清楚）現場檢查問題，您能否提供有關該問題性質的更多詳細資訊？如果存在，那麼需要多長時間才能解決，或者潛在的 HD 批准將被推遲多長時間？

I'll let Marion get into more details about the -- what was driving the quarter for HD. In terms of Catalent, really need to direct those calls to Novo. What we can say in a broad sense that these were not structural changes that are being requested by the FDA. It's not like they have to rebuild something or something of that. They're mainly process procedural, those sorts of things.

我會讓馬里恩更詳細地介紹一下本季 HD 發展的推動因素。就 Catalent 而言，確實需要將這些電話轉接到 Novo。從廣義上講，我們可以說這些並不是 FDA 要求的結構性變化。這並不意味著他們必須重建某些東西或諸如此類的東西。它們主要是流程程序之類的事情。

As we said in our remarks, we do think that they'll provide a robust response. Novo's CEO wrote directly to the FDA and said they're going to elevate all this to the standards of Novo. I believe that we may not be the only (inaudible) because they do -- as I said, they do work for virtually all the bio-pharmaceutical companies. They filled, Catalent filled in its fiscal year '24, something like 70 million or 80 billion unit doses. So I think that this has a good chance of being done expeditiously.

正如我們在評論中所說，我們確實認為他們會做出有力的回應。Novo 的執行長直接寫信給 FDA，表示他們將把所有這些都提升到 Novo 的標準。我相信我們可能不是唯一的（聽不清楚），因為他們確實——正如我所說，他們確實為幾乎所有的生物製藥公司工作。他們在 Catalent 24 財年填充了大約 7000 萬或 800 億單位劑量。因此我認為這項舉措很有可能迅速完成。

But more specifically than that, it's a little early. When we know a little more, we'll get that information out to you. I'll turn it over to Marion to comment on driving of sales for HD.

但更具體地說，現在還為時過早。當我們了解更多時，我們會將這些資訊告知您。我將把話題交給 Marion，請她對 HD 的銷售推動力做出評論。

Thanks, Len. And Tyler, just going back to the numbers, and you were kind of sharing the demand growth in the quarter was impressive. It was a 16% increase, which resulted in our (inaudible) the $393 million in net sales for EYLEA HD in the quarter. We would attribute it to, frankly, physicians appreciation for the product profile that EYLEA HD provides the clinical efficacy, the safety that we've talked about repeatedly and then also the durability that allows patients to have longer periods of time between dosing and the experience with the product has been very, very favorable.

謝謝，Len。泰勒，回到數字上，您說本季的需求成長令人印象深刻。增幅達 16%，導致 EYLEA HD 本季的淨銷售額（聽不清楚）達到 3.93 億美元。坦白說，我們將其歸因於醫生對 EYLEA HD 產品特性的欣賞，該產品提供了臨床療效、我們反复談論的安全性，以及允許患者在服藥之間有更長時間間隔的耐用性，並且該產品的體驗非常非常好。

As I summarize, when we do get the label enhancements, we'll be able to even have more of a trajectory of growth and demand, but certainly very solid performance, and I would attribute it to the product profile and our excellent commercial team.

正如我總結的那樣，當我們確實獲得標籤增強時，我們甚至能夠擁有更多的成長和需求軌跡，但肯定是非常穩健的表現，我將其歸功於產品概況和我們優秀的商業團隊。

Thank you, Len, Marion. Let's move to the next question, please, Shannon.

謝謝你，Len，Marion。請讓我們進入下一個問題，香農。

Chris Schott, J.P. Morgan.

摩根大通的克里斯·肖特。

Just a couple more EYLEA ones as well. Just on the PDUFA beyond the manufacturing dynamics, is there anything else pending with these three filings based on your discussion with FDA? Or are you otherwise confident that once the manufacturing is addressed, we'll be seeing approvals here?

還有幾個 EYLEA 的。除了製造動態之外，關於 PDUFA，根據您與 FDA 的討論，這三份文件還有其他未決事項嗎？或者您有信心，一旦解決了製造問題，我們就會看到批准？

And just the second one, two-part on EYLEA. Just can you talk a little bit about the branded share erosion you're seeing in the category to Avastin? Is that starting to stabilize at all? And how quickly do you expect to recapture some of that lost share once the affordability issues have been addressed. Thank you.

這是第二篇，分為兩部分，關於 EYLEA。您能否稍微談談您在 Avastin 類別中看到的品牌份額侵蝕情況？情況開始穩定了嗎？一旦解決了負擔能力問題，您預計多快能重新奪回部分失去的市場份額。謝謝。

Yes. So I'll comment on the PDUFA and Marion to comment a little bit on the share issues. As far as the PDUFAs go, based on our discussions, we believe that there's nothing significant left to be done. Obviously, some details, but we are expecting once the resolution of the filling issues has occurred to receive favorable action, we hope from the FDA.

是的。因此，我將對 PDUFA 進行評論，而 Marion 則對股票問題發表一些評論。就 PDUFA 而言，根據我們的討論，我們認為已經沒有什麼重大的事情需要做了。顯然，有一些細節，但我們期望，一旦填充問題得到解決，就能得到 FDA 的有利行動。

And then on overall branded dynamic and overall performance, I'll share that -- if you look at total Regeneron EYLEA HD and EYLEA category share, branded share in the quarter was just over 60%. If you look then at growth and what happened in the overall category, anti-VEGF overall category volume did grow the branded anti-VEGF category volume actually decreased by 1.2%, and that would be attributed primarily to the uptick in Avastin based on affordability issues. I don't have a lens into what potential will happen in the future.

然後，關於整體品牌動態和整體表現，我將分享——如果您查看 Regeneron EYLEA HD 和 EYLEA 類別的總份額，本季度的品牌份額略高於 60%。如果你看一下成長情況以及整體類別中發生的情況，你會發現抗 VEGF 整體類別的銷售確實成長了，而品牌抗 VEGF 類別的銷售實際上下降了 1.2%，這主要歸因於基於可負擔性問題的 Avastin 銷量上漲。我無法預見未來可能會發生什麼事。

Right. Next question please, Shannon.

正確的。香農，請問下一個問題。

Geoff Meacham, Citi.

花旗銀行的 Geoff Meacham。

Morning, guys. Long-time listener, first-time caller. Thanks for the question. Len upfront. Internal R&D is really the best use of capital. You got 45 assets already in development. So what's the ROI calculus on how you guys are prioritizing? I wasn't sure if our licensing non-core assets is reasonable, especially given the innovation as a premium now?

早安，大家。長期聽眾，首次來電者。謝謝你的提問。Len 先行。內部研發確實是資本的最佳運用方式。您已擁有 45 項資產正在開發中。那麼你們如何根據投資報酬率計算優先順序呢？我不確定我們的非核心資產許可是否合理，特別是考慮到現在創新已經成為一種溢價？

Geoff, it is for first time, call, it's a good question. I think we certainly have a broad and big pipeline. We have discussed whether or not on occasion, it makes sense to turn over some of those assets. We've done that with our IL-1 blocker and seen pretty good results from our partner who has driven results in pericarditis, which is going very well. We do think there is a potential, but there are some areas where you don't want to do one-offs like oncology, I think what you heard from George, is that part of his original strategy was to have a menu of agents that might be useful to combine. So we probably wouldn't want to do something in that area. But it's a fair point, and we do spend a lot of money on internal R&D, and if it makes sense to partner or out-license, we're certainly not structurally adverse to that.

傑夫，這是第一次打電話，這是個好問題。我認為我們確實擁有廣泛而龐大的管道。我們曾經討論過，有時移交部分資產是否合理。我們已經使用 IL-1 阻斷劑實現了這一點，並且從我們的合作夥伴那裡看到了相當不錯的效果，這對心包炎的治療起到了推動作用，目前進展非常順利。我們確實認為有潛力，但有些領域你不想一次性完成，例如腫瘤學，我想你從喬治那裡聽到的是，他最初的策略的一部分是有一個可能有用的藥物菜單。所以我們可能不想在那個領域做些什麼。但這是一個合理的觀點，我們確實在內部研發上投入了大量資金，如果合作或對外授權是有意義的，我們當然不會從結構上反對這樣做。

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

好的。請讓我們進入下一個問題，香農。

Carter Gould, Cantor.

卡特·古爾德，領唱者。

Good morning. Thanks for taking the question. I know it's only been a month since you formally launched the matching program with Good Days, but can you help us think about if there's been -- if you've delivered any matching fund yet and the extent to which you expect this to, I guess, return as a tailwind to your commercial performance in the back half of the year? Thank you.

早安.感謝您回答這個問題。我知道您與 Good Days 正式啟動配套計劃才一個月，但您能否幫助我們思考一下是否已經——您是否已經交付了任何配套基金，以及您預計這將在多大程度上成為您下半年商業表現的順風？謝謝。

I think it's still early for the program since it's only been in place for about a month. And therefore, I don't think we have any useful information to share. We'll get to that later this quarter or at the end of the quarter. But we haven't heard through the grapevine of any major contributions yet. But we're watching this space very closely. We really do hope that our contribution in a matching form will stimulate others to contribute. But thus far, we don't have a lot to report.

我認為該計劃還為時過早，因為它才實施了一個月左右。因此，我認為我們沒有任何有用的信息可以分享。我們將在本季晚些時候或季度末解決該問題。但我們尚未聽到任何重大捐款的消息。但我們正密切關注這一領域。我們確實希望我們以匹配形式做出的貢獻能激勵其他人做出貢獻。但到目前為止，我們還沒有太多可報告的資訊。

Thanks, Len. Next question, please, Shannon.

謝謝，Len。香農，請問下一個問題。

Cory Kasimov, Evercore ISI.

Cory Kasimov，Evercore ISI。

Good morning, guys. Thanks for taking the question. Curious as to your thoughts on the competitive OX40-ligand data shared thus far and how you believe this potentially competes with Dupixent's overall profile? Thank you.

大家早安。感謝您回答這個問題。好奇您對迄今為止分享的競爭性 OX40 配體數據的看法，以及您認為這可能如何與 Dupixent 的整體概況競爭？謝謝。

George, do you want to cover that?

喬治，你想報道一下嗎？

Well, the data is interesting. Right now, I don't it think suggests that it's offering really any advantages and certainly it'll be a long time before it can approach the comfort of the safety profile. Let me just remind you that Dupixent is one of the only, if not, the only immunomodulator in the world that we've shown largely attacks of this digital pathway, which is largely not necessary to people living in the developed world. Because it's part of the immune system that was designed to attack largely obsolete pathogens that we no longer have to fight in developed countries.

嗯，數據很有趣。目前，我認為它並沒有真正提供任何優勢，而且它還需要很長時間才能達到安全方面的舒適度。我只想提醒你，Dupixent 是世界上僅有的幾種免疫調節劑之一，即使不是唯一的一種，我們已經證明它對這種數字通路的攻擊作用很大，而這對於生活在發達國家的人們來說基本上是沒有必要的。因為它是免疫系統的一部分，其目的是為了攻擊已開發國家不再需要對抗的過時病原體。

Most other approaches, including the OX40 approaches and so forth, are much more general approaches that attack fundamental parts of the immune system that are required very broadly. And so it's going to be a long time before you would feel comfortable that you have the safety profile that you have with Dupixent.

大多數其他方法，包括 OX40 方法等，都是更通用的方法，可以攻擊廣泛需要的免疫系統的基本部分。因此，還需要很長時間，您才能對 Dupixent 的安全性感到放心。

So one of the miracles of Dupixent is its incredible efficacy, which is so far relatively unmatched. But just as if not more importantly, that its an immunomodulator that actually corrects the immune system and does not debilitate it by creating any profound immunosuppression.

因此，Dupixent 的奇蹟之一是其令人難以置信的療效，迄今為止相對無與倫比。但同樣，甚至更重要的是，它是一種免疫調節劑，可以真正糾正免疫系統，而不會透過產生任何嚴重的免疫抑製而削弱免疫系統。

So I think now when you look at other agents, whether you're talking about OX40, you're talking about the JAKs, or anything else, they are much broader at attacking the immune system. And so it's going to take a long time, I think, to develop the sort of comfort that one has with the incredible safety profile of Dupixent, let alone its efficacy.

所以我認為現在當你看其他藥物時，無論你談論的是 OX40、JAK 還是其他任何東西，它們在攻擊免疫系統方面的作用更為廣泛。因此，我認為，要讓人們對 Dupixent 的出色安全性和有效性感到放心，還需要很長時間。

And to correlate, of course, to what George was saying about attacking broadly is that we will deal with patients who have comorbidities. And we can do that in a way that I don't think any other agent has suggested that we'll be able to do. There are so many people who have asthma with atopic dermatitis or asthma with nasal polyps or asthma with eosinophilic esophagitis and so on. And so that fundamental mechanism of attacking this Type 2 pathway that George is referring to, gives us this commercial advantage as well because it attacks so many common diseases that many people have. And that also don't need to get familiar with many different drugs in this allergy spectrum when one like Dupixent can cut across so many. Next question?

當然，與喬治所說的廣泛攻擊相關的是，我們將處理患有合併症的患者。我們可以以一種我認為其他代理商都沒有建議過的方式來做到這一點。有很多人患有伴隨異位性皮膚炎的氣喘、伴隨鼻息肉的氣喘、伴隨嗜酸性食道炎的氣喘等等。因此，喬治提到的攻擊 2 型路徑的基本機制也為我們帶來了商業優勢，因為它可以攻擊許多人患有的許多常見疾病。而且，當像 Dupixent 這樣的藥物可以治療多種過敏症狀時，人們不需要熟悉這種過敏譜中的許多不同藥物。下一個問題？

Next question. Shannon, let's go to the next caller, please.

下一個問題。香農，請接聽下一位來電者。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

Hi guys. Thank you so much for taking my question. I want to touch on some thoughts around MFN. So with some of your key products marketed outside of the United States by partners, specifically European partners, what mechanisms or abilities do you have to impact pricing OUS? Is there anything you can really do to force a higher price from a partner?

嗨，大家好。非常感謝您回答我的問題。我想談談有關最惠國待遇的一些想法。那麼，當您的一些主要產品由合作夥伴（特別是歐洲合作夥伴）在美國以外銷售時，您有什麼機製或能力來影響 OUS 的定價？您能做些什麼來迫使合作夥伴提高價格嗎？

Yeah. It's a great question. I think that one of the issues and that new contracts will -- since this is going to apply mainly to new drugs according to the letter -- Dear Len Letter, as it's being known in the industry now. The Dear Len Letter suggested that you have to do this on new products, it's not an old products. And one of the reasons may be because of that complication.

是的。這是一個很好的問題。我認為其中一個問題是，新合約將——因為根據信中的內容，這將主要適用於新藥——親愛的 Len 的信，正如現在業內所知。親愛的 Len 的信建議您必須對新產品執行此操作，而不是對舊產品執行此操作。其中一個原因可能就是由於這種複雜性。

I suspect a lot of new contracts we'll have to deal with the contingency of what happens when -- if you license something to Europe. But Evan, it's really a great question because, for example, we don't control the pricing of EYLEA outside the United States. That's controlled by Bayer. So these are some of the wrinkles that are going to have to be figured out. Thanks for pointing that out.

我認為，在簽訂許多新合約時，我們都必須應對在向歐洲授權某些產品時可能發生的意外情況。但埃文，這確實是一個很好的問題，因為例如，我們無法控制美國以外地區 EYLEA 的定價。它由拜耳控制。所以這些都是需要解決的一些問題。感謝您指出這一點。

Let's go to the next question, please, Shannon.

請讓我們進入下一個問題，香農。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

Hey. Thanks so much. On Pavblu, we were internally going to see the ASP decline to kind of reflect Amgen's volume-based discounts and we felt like that would then, in turn, drop physician demand like we've seen with Cimerli. Interestingly, the ASP actually hasn't declined that much, suggesting Amgen may be offering deferred discounts. So for the Regeneron team, how does the prolonged run rate for Pavblu impact your outlook for EYLEA? You mentioned continued decline. And number two, are there any options you're exploring here to combat this strategy? Thank you.

嘿。非常感謝。對於 Pavblu，我們內部預計平均售價會下降，這在某種程度上反映了安進的批量折扣，我們覺得這反過來會降低醫生的需求，就像我們在 Cimerli 身上看到的那樣。有趣的是，平均售價實際上並沒有下降那麼多，這表明安進可能正在提供延期折扣。那麼對於 Regeneron 團隊來說，Pavblu 的長期運行率如何影響您對 EYLEA 的前景？您提到了持續下降。第二，您是否正在探索什麼方法來對抗這種策略？謝謝。

I don't want to get into practices that some might deem inappropriate, in terms of deferring of rebates. But that's something we're sort of looking into as to whether that is driving some of their success. At the end of the day, you have a product that globally has probably had something like 100 million injections. It's not just the product, but it's also the surety of how you make it and how doctors trust it and so on and so forth. But Pavblu is a competitor, and we're out there. We think that HD is the real answer to that. And as many people has experienced with it, we think that's going to be a much preferred drug than EYLEA or Pavblu.

我不想採取一些人認為不恰當的延遲回扣的做法。但我們正在研究這是否是他們成功的原因。最終，你的產品在全球範圍內可能已經注射了大約 1 億次。它不僅僅是產品，也是如何製造產品的保證、醫生如何信任產品等等。但 Pavblu 是我們的一個競爭對手，而且我們也在競爭。我們認為 HD 才是真正的答案。而且正如許多人體驗過的那樣，我們認為它將是一種比 EYLEA 或 Pavblu 更受歡迎的藥物。

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

請讓我們進入下一個問題，香農。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

Great. Thanks for taking the question. You mentioned in the fianlimab first line melanoma study that the event rate is slowing. So just wondering if you could speculate on reasons there and just speak to your confidence level in showing a positive readout here and remind us what the efficacy bars that you're looking for and hoping to show. Thank you.

偉大的。感謝您回答這個問題。您在 fianlimab 一線黑色素瘤研究中提到，事件發生率正在放緩。所以只是想知道您是否可以推測一下其中的原因，並談談您對在這裡顯示積極讀數的信心水平，並提醒我們您正在尋找並希望顯示的功效條。謝謝。

Well, I think that you can make a lot of speculations on what it means when you have less events than you might have planned or powered for. That said, what we're powering for is having minimally the sort of effect that the competitors have shown. Of course, with room to show perhaps even a better effect. And as we said, because of the slowing of the event rates, it has now delayed when we're going to get these results.

嗯，我認為你可以對當你舉辦的活動比你計劃或準備的少時意味著什麼做出很多推測。話雖如此，我們全力以赴所取得的效果卻遠遠不及競爭對手。當然，如果有空間展示也許效果會更好。正如我們所說，由於事件發生率的下降，我們獲得這些結果的時間已經被推遲。

This way you do a blinded study. We've looked at hundreds of studies over the years. We have engaged in speculations. George probably has the most insight of anybody. But the bottom line is we just have to wait until the unblinding.

這樣你就完成了盲法研究。多年來，我們已經研究了數百項研究。我們進行了猜測。喬治可能是最有洞察力的人。但底線是我們必須等待，直到揭開謎底。

Move to the next question, please, Shannon.

請進入下一個問題，香農。

Dave Risinger, Leerink Partners.

Dave Risinger，Leerink Partners。

Thanks very much and thanks for all the updates. I guess my question is for Len and George. So there's a tremendous disconnect between Regeneron management's view of its pipeline and Wall Street's views. I think that the company is spending about $5 billion a year on R&D and 2032 consensus pipeline estimates are about $3.5 billion. So maybe you could share some light on the event path ahead for Regeneron to shine better light on the commercial value of its pipeline? Thank you.

非常感謝，感謝所有的更新。我想我這個問題是針對 Len 和 George 的。因此，再生元管理層對其管道的看法與華爾街的看法之間存在巨大差異。我認為該公司每年在研發上的花費約為 50 億美元，而 2032 年的一致預期研發投入約為 35 億美元。那麼，也許您可以分享一些有關 Regeneron 未來事件路徑的信息，以更好地展現其管道的商業價值？謝謝。

Sure. David, thanks for your question. It's a fair question. I think I would say two things before turning it over to George. First, I would say that history frequently is a good indicator. Our research organization has produced two of the most important drugs in the history of the industry, including EYLEA and Dupixent. And I think that that's the first thing I would say.

當然。大衛，謝謝你的提問。這是一個公平的問題。在將話題交給喬治之前，我想說兩件事。首先，我想說歷史通常是一個很好的指標。我們的研究機構生產了該行業歷史上最重要的兩種藥物，包括EYLEA和Dupixent。我想這是我要說的第一件事。

The second thing I would say is that you should perhaps listen very carefully and maybe George can reiterate some of what he said on the call today about just as an example of one area of our pipeline, which was really new and exciting on these data in early-stage myeloma, (inaudible) myeloma and early-stage DLBCL lymphoma are really quite, quite encouraging for us and we are going full steam ahead into myeloma. We're going to probably have somewhere in the neighborhood of eight different Phase 3s going by next year. That's a $30 billion market. And it will grow substantially as it moves into the premalignant stage. Big opportunities. So George, you want to add anything there?

我想說的第二件事是，你也許應該非常仔細地聽，也許喬治可以重申一下他在今天電話會議上所說的一些內容，作為我們產品線一個領域的例子，這些領域在早期骨髓瘤、（聽不清）骨髓瘤和早期 DLBCL 淋巴瘤方面的數據確實是新穎和令人興奮的，這對我們來說確實非常令人鼓舞，我們將全力以赴地進入骨髓瘤領域。到明年，我們可能會啟動大約八個不同的第三階段專案。這是一個價值300億美元的市場。當它進入癌前階段時，它會大幅成長。巨大的機會。那麼喬治，你想添加什麼嗎？

Well, I think we all have to understand and acknowledge that probably the valuation or view of the pipeline is, in many ways, being capped by concerns about what's going on with our existing mega products. And whether they're going to show growth above and beyond what's going to be happening with those products.

嗯，我認為我們都必須理解並承認，在許多方面，對現有大型產品的擔憂可能限制了對管道的估值或觀點。以及它們是否將表現出超越這些產品的成長。

I think if one was independently looking at any one of these various new opportunities, like Len said, we believe that our BCMA bispecific, which right now has the best data in one of the most exciting new classes in the entire industry, has a chance to become another one of the most important drugs in the industry. Based on certainly a lot of the data that I described today in terms of run-in portions of many of our Phase 3 programs with it. And we have several such programs.

我認為，如果一個人獨立地看待這些新機會中的任何一個，就像 Len 所說的那樣，我們相信我們的 BCMA 雙特異性藥物有機會成為該行業中另一個最重要的藥物，它目前擁有整個行業中最令人興奮的新類別之一中的最佳數據。這當然是基於我今天描述的大量數據，這些數據涉及我們許多第三階段專案的運行部分。我們有幾個這樣的項目。

But I think right now, the excitement and enthusiasm of those has always been limited by people who want to know, well, what's going to happen with EYLEA and so forth. So I think that our pipeline would be viewed very differently if it was viewed in isolation because of the incredible potential opportunities. And as Len said, one of the best predictors of whether people can really do something important is whether they've repeatedly done that in the past.

但我認為現在，人們的興奮和熱情一直受到限制，因為他們想知道 EYLEA 等會發生什麼。因此，我認為，如果孤立地看待我們的管道，人們會對我們的管道有非常不同的看法，因為它蘊藏著巨大的潛在機會。正如倫所說，判斷人們是否真的能夠做一些重要的事情的最佳指標之一是他們過去是否反覆做過這件事。

So one other thing I would just add, David, is that if you think about where the big opportunities are, lymphoma, myeloma, all the complement-mediated diseases, geographic atrophy, myasthenia gravis, PNH, where we think we have best-in-class (inaudible). On top of that, all of the thrombotic diseases with our two different offerings in that. We've got a lot to do, but we've got a lot of exciting things. We're going to have some updates, hopefully, in the near future for our allergy program for birch and for cat allergy and our broad general allergy program. This is, I would say, an investment that is really going to have strong returns.

因此，大衛，我還要補充一點，如果你想想哪裡有大的機會，淋巴瘤、骨髓瘤、所有補體介導的疾病、地圖狀萎縮、重症肌無力、陣發性肺結核 (PNH)，我們認為我們擁有一流的（聽不清楚）。除此之外，我們還提供兩種不同的產品來治療所有血栓性疾病。我們有很多事情要做，但也有很多令人興奮的事情。希望在不久的將來，我們能對樺木過敏、貓過敏以及廣泛的一般過敏計劃進行一些更新。我想說，這是一項確實會帶來豐厚回報的投資。

And it is hard for any one analyst or anyone analyst team to look at 45 programs or if you've got 10 different companies and the other nine have two programs each, you could consume all the time. And that's maybe why it doesn't get as much attention as we would like, but we're really excited about it. And I would encourage all of you to go back and listen very carefully to what George said today as a hint on what could happen in this mega, mega space of myeloma.

對於任何一位分析師或任何一位分析師團隊來說，查看 45 個項目都是很困難的，或者如果你有 10 家不同的公司，而其他 9 家公司各有兩個項目，那麼你就可以一直消耗它們。這也許就是為什麼它沒有得到我們所希望的那麼多關注，但我們對此感到非常興奮。我鼓勵大家回去仔細聽聽喬治今天所說的話，以了解在骨髓瘤這個巨型空間中可能發生的情況。

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

請讓我們進入下一個問題，香農。

Alexandria Hammond, Wolfe Research.

亞歷山大‧哈蒙德，沃爾夫研究公司。

Thanks for taking the question. And I got a lot of focus on the pipeline, to Len's point. So one of the lesser talked about programs is Regeneron's (inaudible) readout in gMG. So as that readout approaches, can you just remind us again of the bar for success? I guess, what do you think you need to be commercially successful there? Thank you.

感謝您回答這個問題。正如 Len 所說，我非常關注管道。因此，較少被談論的項目之一是 Regeneron 在 gMG 的讀數（聽不清楚）。那麼，隨著讀數的臨近，您能否再次提醒我們成功的標準？我想，您認為您需要做什麼才能在那裡取得商業上的成功？謝謝。

Well, I can speak to what we need to be clinically successful. And maybe I'll leave it for Marion for speculation about what we need to be commercially successful. We are setting the bar pretty much at the bar that has been achieved with all other agents that are now being utilized in this class. But what we think we may have to offer is one of the more convenient dosing regimens.

好吧，我可以談談我們需要做些什麼才能取得臨床成功。或許我應該讓馬里恩來猜測我們需要什麼才能取得商業上的成功。我們設定的標準與目前同類產品中使用的所有其他代理商所達到的標準基本一致。但我們認為我們可以提供的是一種更方便的給藥方案。

In myasthenia gravis, we don't necessarily think that the sort of extent of blockade and so forth is going to be as important as it is in other diseases in order to demonstrate better efficacy. So the play in myasthenia gravis is to show similar benefit, but with a much more convenient dosing regimen.

對於重症肌無力，我們不認為阻斷的程度等會像其他疾病一樣重要，以便顯示出更好的療效。因此，該藥物在重症肌無力治療中顯示了類似的益處，但給藥方案卻更方便。

Let me just remind you, we have a monthly self-administered subcutaneous regimen which, compared to other dosing regimens which tend to be IV infusions, often administered much more frequently or even subcutaneous daily injections, we think that those could have a lot of advantages for patients if they demonstrated similar types of efficacy.

我只想提醒您，我們有一個每月自行注射皮下藥物的方案，與其他給藥方案（往往是靜脈輸液，通常給藥更頻繁，甚至是每日皮下注射）相比，我們認為，如果這些方案表現出類似的療效，那麼它們可以為患者帶來很多好處。

But the approach also can better control complement activity. And in several other diseases that we're exploring, we think that that can translate to actually an efficacy improvement as well.

但這種方法也能更好地控制補體活性。對於我們正在研究的其他幾種疾病，我們認為這實際上也可以轉化為療效的改善。

And I would add to George's comments that this is a large indication. There's a lot of unmet need. And then on top of that, if we're able to have a differentiated product that offers the conveniences that George has mentioned, that would be very, very important. Any additional efficacy benefit is always meaningful. And to this point, the safety profile looks very good. So we look forward to participating in this market.

我想補充喬治的評論，這是一個很大的跡象。還有很多需求尚未滿足。除此之外，如果我們能夠擁有一款能夠提供喬治所提到的便利的差異化產品，那將非常非常重要。任何額外的功效益處總是有意義的。到目前為止，安全性看起來非常好。所以我們期待參與這個市場。

We have time for two more questions, please, Shannon.

香農，我們還有時間回答另外兩個問題。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Hey. Good morning. Thanks for taking my question and, congrats on the quarter. On itepekimab, just wondering if you had any new insights on why the AERIFY-2 study didn't hit its primary endpoint and the feasibility of mitigating that in future studies? And then maybe any potential adjustments you may consider to the ongoing studies in other indications? Thanks.

嘿。早安.感謝您回答我的問題，並祝賀本季取得佳績。關於 itepekimab，我只是想知道您是否對 AERIFY-2 研究為何未達到其主要終點以及在未來的研究中緩解這種情況的可行性有什麼新的見解？那麼，您是否會考慮對正在進行的其他適應症研究進行一些潛在的調整？謝謝。

Yeah. That's a great question. I mean it's interesting that, of course, we just saw two studies from a competitor that, in general, on average, had lower efficacy than we saw. But the two studies were quite similar in what the two studies showed in contrast to what we saw.

是的。這是一個很好的問題。我的意思是，有趣的是，當然，我們剛剛看到競爭對手的兩項研究，總體而言，平均而言，其功效低於我們所看到的。但與我們所看到的結果相比，這兩項研究的結果非常相似。

Let me remind you. Our two studies look quite similar at the six-month time point. And one of the studies just turned south at that point. We've been looking at it, trying to figure it out. We have some ideas. Of course, one of the major factors was the study was primarily carried out during a very unusual time in the world for clinical trials and the height of the pandemic and so forth.

讓我提醒你。我們的兩項研究在六個月的時間點上看起來非常相似。其中一項研究就在那時出現了結果不佳的情況。我們一直在觀察它，試著弄清楚。我們有一些想法。當然，其中一個主要因素是，這項研究主要是在世界上臨床試驗非常不尋常的時期以及疫情最嚴重的時候進行的。

And there was a lot of things happened at that time. The rates of exacerbations drop precipitously because people avoided going outside and therefore, there were less exacerbations as noted worldwide, let alone in the study, and so forth. There were a lot of other associated events. And so we are trying to figure it out. And as I said, we're discussing how to go forward and the possibility of carrying out an additional Phase 3.

當時發生了很多事。由於人們避免外出，疾病發作率急劇下降，因此，全球範圍內的疾病發作次數減少，更不用說研究中的疾病發作次數了，等等。還有很多其他相關事件。所以我們正在努力解決這個問題。正如我所說，我們正在討論如何推進以及進行第三階段的可能性。

Thanks, George. Shannon, last question, please.

謝謝，喬治。香農，請問最後一個問題。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good morning. Thanks for taking my question. With regard to business development, you spoke to the flexibility today and the fact that you're considering differentiated later-stage opportunities in areas with high unmet need. Can you just help us understand how you think about that in the context of your overall business?

早安.感謝您回答我的問題。關於業務發展，您今天談到了靈活性，以及您正在考慮在未滿足需求較高的領域提供差異化的後期機會。您能否幫助我們了解您在整個業務背景下對此的看法？

Yeah. We spent a lot of time looking at a lot of things. And one of the metrics that we're developing, which we hope maybe some analysts will adopt and investors might adopt, is combining the money spent by a company in research and development and acquiring research and development through a variety of deals, transactions, acquisitions, licensing, milestones and so forth.

是的。我們花了很多時間觀察很多事情。我們正在開發的指標之一是將公司在研發上花費的資金與透過各種交易、收購、授權、里程碑等方式獲得的研發資金相結合，我們希望一些分析師和投資者可能會採用這個指標。

And I think you might find out and you might be surprised that we don't spend that much more, perhaps, on overall acquisition of products through research. We just spend more of it internally because our research efforts are so productive.

我想你可能會發現，你可能會感到驚訝，也許我們在透過研究整體來獲取產品上花費的錢並沒有那麼多。由於我們的研究工作非常富有成效，所以我們在內部投入了更多資金。

But once again, we want the best stuff for patients. And so we go outside and look and look and look. And occasionally, we do find stuff. And if we have to do it, we have a lot of flexibility to do it, Salveen. But we don't -- to us, it's not a lifeline like it is for so many companies. And even though people think it's their lifeline, I think more often, they're pulling on threads and it's not really pulling them up anywhere because it's very hard to be successful buying things from the outside where you really don't know all the nitty-gritty, warts, and so forth.

但再次強調，我們希望為患者提供最好的治療。於是我們就到外面去看看。偶爾，我們確實能找到一些東西。如果我們必須這麼做，我們有很大靈活性，薩爾文。但我們不這麼認為——對我們來說，它不像對許多公司那樣是一條生命線。儘管人們認為這是他們的生命線，但我認為更多的時候，他們只是在拉線，而並沒有真正起到什麼作用，因為從外部購買東西很難成功，因為你真的不了解所有的細節、缺點等等。

But having said all that, every day, we approach it with an open mind, and look at tons of stuff.

但話雖如此，每天我們都以開放的心態去對待它，並觀察大量的事物。

Okay. Thank you, Len. And thanks to everyone who joined today's call and for your interest in Regeneron. We apologize to those that are remaining in the Q&A queue. We simply ran out of time and not have a chance to hear from you today. But as always, the Investor Relations team is available to answer any remaining questions you may have. Thank you once again and have a great day and a great weekend.

好的。謝謝你，Len。感謝今天參加電話會議的所有人以及你們對 Regeneron 的關注。我們向仍在問答隊列中的人們表示歉意。我們只是沒有時間，今天沒有機會聽取您的意見。但與往常一樣，投資者關係團隊可以回答您可能有的任何其他問題。再次感謝您，祝您有個愉快的一天和週末。

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。