雷傑納榮製藥 (REGN) 2024 Q3 法說會逐字稿

Good morning, and welcome to the Regeneron Pharmaceuticals third-quarter 2024 earnings conference call. My name is Shannon, and I will be your operator for today's call. (Operator Instructions)

早安，歡迎參加再生元製藥 2024 年第三季財報電話會議。我叫香農，我將擔任今天通話的接線生。 （操作員說明）

Please note that this conference call is being recorded. I will now turn the call over to Ryan Crowe, Senior President, Investor Relations. You may begin.

請注意，本次電話會議正在錄音。我現在將電話轉給投資者關係高級總裁 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 third-quarter 2024 earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after the call ends.

謝謝你，香農。世界各地的聽眾早安、下午好、晚上好。感謝您對再生元的關注，歡迎參加我們的 2024 年第三季財報電話會議。通話結束後不久，再生元投資者關係網站將提供本次通話的檔案和文字記錄。

Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair 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, Senior Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for your questions.

與我一起參加今天電話會議的還有董事會聯合主席、創辦人、總裁兼執行長 Leonard Schleifer 博士； George Yancopoulos 博士，董事會聯合主席、共同創辦人、總裁兼首席科學官； Marion McCourt，商務執行副總裁；以及資深副總裁兼財務長 Chris Fenimore。在我們準備好發言後，剩下的時間將用於回答您的問題。

I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron.

我想提醒您，今天電話會議的言論可能包括有關再生元的前瞻性陳述。

Such statements may include, but are not limited to, those related to Regeneron and its products 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.

此類聲明可能包括但不限於與再生元及其產品業務、財務預測和指導、開發計劃和相關預期里程碑、合作、財務、監管事項、付款人覆蓋範圍和報銷、智慧財產權、未決訴訟和其他程序和競爭。

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.

每項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。

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, 2024, which was filed with the SEC this morning.

有關這些風險和其他重大風險的更完整描述可以在 Regeneron 向美國證券交易委員會提交的文件中找到，其中包括今天上午向 SEC 提交的截至 2024 年 9 月 30 日的季度的 10-Q 表。

Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

再生元不承擔任何更新任何前瞻性陳述的義務，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.

此外，請注意，今天的電話會議將討論公認會計原則和非公認會計原則財務指標。

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 accessed on the Regeneron Investor Relations website.

有關我們使用非公認會計準則財務指標以及這些指標與公認會計準則的調節的信息，請參閱我們的季度業績新聞稿和公司演示文稿，這兩者都可以在再生元投資者關係網站上訪問。

Once our call concludes, Chris and the IR team will be available to answer any further questions you may have.

在我們的通話結束後，Chris 和 IR 團隊將可以回答您可能提出的任何進一步問題。

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

接下來，讓我將電話轉給我們的總裁兼執行長 Leonard Schleifer 博士。

Len?

萊恩？

Thank you, Wayne, and thanks to everyone for joining today's call.

謝謝你，韋恩，也謝謝大家參加今天的電話會議。

We generally had a strong quarter, highlighted by 11% revenue growth and 8% non-GAAP earnings growth along with continued investments and advances across our broad pipeline.

我們的季度整體表現強勁，主要表現在 11% 的營收成長和 8% 的非 GAAP 獲利成長，以及我們廣泛管道的持續投資和進步。

For my remarks today, I'd like to review some of our key performance drivers and then briefly discuss near-term pipeline opportunities.

在今天的演講中，我想回顧我們的一些關鍵績效驅動因素，然後簡要討論近期的管道機會。

After my remarks, George will provide further updates on our pipeline.

在我發言後，喬治將提供有關我們管道的進一步更新。

Marion will then review our commercial performance.

然後，馬里昂將審查我們的商業表現。

And finally, Chris will detail our quarterly financial results.

最後，克里斯將詳細介紹我們的季度財務表現。

Third-quarter 2024 total revenues grew 11% to $3.72 billion, primarily driven by higher Sanofi collaboration revenues, reflecting the continued strong performance of Dupixent continued growth for Libtayo and growth for combined EYLEA HD and EYLEA in the United States.

2024 年第三季總營收成長 11%，達到 37.2 億美元，主要受到賽諾菲合作收入增加的推動，反映出 Dupixent 的持續強勁業績以及 Libtayo 的持續成長以及 EYLEA HD 和 EYLEA 在美國的合併成長。

DUPIXENT had another strong quarter with global revenues up 24% on a constant currency basis to $3.8 billion.

DUPIXENT 又一個強勁的季度，以固定匯率計算，全球營收成長 24%，達到 38 億美元。

With this latest quarterly result, global DUPIXENT revenues are annualizing at over $15 billion, with over 1 million patients currently on treatment around the world across seven approved indications in patients as young as six months.

根據最新的季度業績，全球 DUPIXENT 收入年化超過 150 億美元，目前全球有超過 100 萬名患者正在接受七種已批准適應症的治療，患者年齡最小為 6 個月大。

In September, the FDA and Chinese regulators, both approved DUPIXENT for patients with uncontrolled COPD and an eosinophilic phenotype.

9月，FDA和中國監管機構均批准DUPIXENT用於治療未受控制的慢性阻塞性肺病和嗜酸性粒細胞表型患者。

These approvals, along with the approval in Europe in June, enabled DUPIXENT to address several hundred thousand patients that are currently uncontrolled on maximum inhaled triple therapy.

這些批准，加上 6 月在歐洲的批准，使 DUPIXENT 能夠解決目前接受最大吸入性三聯療法無法控制的數十萬名患者的問題。

As Marion will discuss, early launch indicators have been positive with span physician interest and initial favorable US coverage decisions.

正如馬里昂將討論的那樣，早期推出指標一直積極，跨度醫生的興趣和最初有利的美國核保決定。

As the only approved biologic for COPD, we anticipate these ongoing launches where we represent a meaningful driver for DUPIXENT continued growth in 2025 and beyond.

作為唯一獲得批准的慢性阻塞性肺病生物製劑，我們預計這些持續的上市將成為 DUPIXENT 在 2025 年及以後持續增長的有意義的推動力。

Net product sales for EYLEA HD and EYLEA combined were $1.54 billion, up 3% compared to the prior year.

EYLEA HD 和 EYLEA 的產品淨銷售額合計為 15.4 億美元，比上年增長 3%。

EYLEA HD generated $392 million in its fourth full quarter on the US market.

EYLEA HD 在美國市場的第四個完整季度創造了 3.92 億美元的收入。

EYLEA HD and EYLEA maintained anti-VEGF category leadership with combined share of approximately 44% compared to 45% in the second quarter of 2024.

EYLEA HD 和 EYLEA 保持了抗 VEGF 類別的領先地位，總計份額約為 44%，而 2024 年第二季為 45%。

As Marion will discuss, we are focused on increasing EYLEA HD share while reserving share for EYLEA in an increasingly competitive category, including a near-term biosimilar aflibercept 2-milligram launch and the recent launch of a branded prefilled sewage.

正如Marion 將討論的那樣，我們的重點是增加EYLEA HD 份額，同時為EYLEA 在競爭日益激烈的類別中保留份額，包括近期推出的生物仿製藥阿柏西普2 毫克以及最近推出的品牌預裝污水。

The EYLEA HD clinical profile continues to look differentiated relative to EYLEA and other anti-VEGF products.

相對於 EYLEA 和其他抗 VEGF 產品，EYLEA HD 的臨床特徵看起來仍然有所不同。

As George will soon detail, results from the recently reported Photon extension study in DME further underscore EYLEA HD's unprecedented durability while achieving vision gains and the safety profile typically seen with EYLEA.

正如 George 很快就會詳細介紹的那樣，最近報導的 DME 光子延伸研究的結果進一步強調了 EYLEA HD 前所未有的耐用性，同時實現了 EYLEA 常見的視力增益和安全性。

Moving to our pipeline.

轉向我們的管道。

We are excited about several upcoming readouts later this year and in 2025 to further inform programs that could support significant long-term growth opportunities.

我們對今年稍後和 2025 年即將發布的幾份報告感到興奮，這些報告將進一步為可支持重大長期成長機會的計畫提供資訊。

By year-end, we expect to share interim Phase II lung cancer data for the combination of fianlamab, our LAG-3 antibody plus Libtayo as well as proof of concept data for our Factor XI antibodies in thrombosis both of which will inform our Phase III plans.

到年底，我們預計將分享fianlamab、我們的LAG-3 抗體加Libtayo 組合的中期II 期肺癌數據，以及我們的XI 因子抗體在血栓形成中的概念驗證數據，這兩者都將為我們的III 期臨床研究提供資訊計劃。

Looking ahead to 2025, we expect to read out the results of our pivotal ERP studies for itepekimab our IL-33 antibody in former smokers with COPD.

展望 2025 年，我們預計將公佈針對患有慢性阻塞性肺病 (COPD) 的前吸煙者的 itepekimab（我們的 IL-33 抗體）的關鍵 ERP 研究結果。

We will also learn more about potential opportunity to improve the quality of weight loss in obese patients on semiglutide by blocking myostatin and or Activin A. Pivotal data for the fianlimab-libtayo combination in first-line metastatic melanoma are also anticipated, which could support regulatory filings in this setting.

我們還將了解更多關於透過阻斷肌生長抑制素和/或激活素A 來改善接受半魯肽的肥胖患者減肥品質的潛在機會。數據，這可以支援監管在此設定下提交的文件。

In addition, we expect to provide periodic updates on our novel treatment approach for reversing severe food allergies involving linvoseltamab, our BCMA by CD3 bispecific and DUPIXENT.

此外，我們希望定期更新我們用於逆轉嚴重食物過敏的新治療方法，包括 linvoseltamab、我們的 CD3 雙特異性 BCMA 和 DUPIXENT。

In closing, our pipeline continues to generate innovative and differentiated opportunities and now had approximately 40 programs in clinical development spanning many distinct therapeutic areas.

最後，我們的產品線繼續創造創新和差異化的機會，目前擁有約 40 個臨床開發項目，涵蓋許多不同的治療領域。

We view our pipeline as the key to driving medium- and long-term shareholder value and our antibody platform technologies and the Regeneron Genetics centered database of over 2.5 million sequenced exomes linked to the de-identified health records is expected to provide an enduring competitive advantage that we will continue to invest in.

我們將我們的管道視為推動中長期股東價值的關鍵，我們的抗體平台技術和以Regeneron Genetics 為中心的資料庫（包含與去識別化健康記錄相關的超過250 萬個已測序外顯子組）預計將提供持久的競爭優勢我們將繼續投資。

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

現在我將把電話轉給喬治。

Thanks, Leonard.

謝謝，倫納德。

I'll start with EYLEA HD and the data from the Photon extension study in diabetic macular edema, that were recently presented at the American Academy of Ophthalmology Annual Meeting.

我將從 EYLEA HD 和來自糖尿病黃斑水腫的光子擴展研究的數據開始，這些數據最近在美國眼科學會年會上發表。

In addition to demonstrating that the vision gains and anatomic achievements or improvements with EYLEA HD over two years could be sustained over a third year of treatment at EYLEA HD, the results of the extension study provided the first data for patients who switched from EYLEA to EYLEA HD.

In addition to demonstrating that the vision gains and anatomic achievements or improvements with EYLEA HD over two years could be sustained over a third year of treatment at EYLEA HD, the results of the extension study provided the first data for patients who switched from EYLEA to EYLEA高畫質.

For these switch patients who were dosed for 88 weeks with EYLEA every eight weeks following five initial loading doses, retinal fluid reaccumulation was substantially slower after a single EYLEA HD injection at week 96 as compared to these patients' previous rate of fluid accumulation with our EYLEA HD 2 milligram.

對於這些在五次初始負荷劑量後每八週接受EYLEA 治療88 週的轉換患者，與這些患者之前使用我們的EYLEA 時的液體積聚率相比，在第96 週單次EYLEA HD 注射後，視網膜液體再積聚速度明顯減慢高清2毫克。

In addition, after one year of EYLEA HD treatment, 83% of these switch patients had a last assigned dosing interval of at least 12 weeks.

此外，在接受 EYLEA HD 治療一年後，83% 的轉換患者的最後指定給藥間隔至少為 12 週。

Importantly, mean visual and anatomic achievement improvements achieved with EYLEA were sustained following the switch to longer dosing intervals with EYLEA HD.

重要的是，在使用 EYLEA HD 改用更長的給藥間隔後，使用 EYLEA 實現的平均視覺和解剖學成績的改善得以持續。

For Photon, patients assigned to EYLEA HD treatment groups at baseline, visual games and anatomic improvements achieved in the first two years were all sustained in three years, but many of these patients were able to meaningfully extend the dosing interval.

對於 Photon，在基線時分配到 EYLEA HD 治療組的患者在前兩年實現的視覺遊戲和解剖學改善均在三年內得以維持，但其中許多患者能夠有意義地延長給藥間隔。

At the end of three years of treatment, nearly half were signed the final dosing interval of at least 20 weeks.

三年治療結束時，近一半患者簽署了至少 20 週的最終給藥間隔。

In summary, EYLEA HD achieved consistently longer dosing intervals as well as notably slower fluid reaccumulation as compared to EYLEA, a first for the category.

總之，與 EYLEA 相比，EYLEA HD 始終實現更長的給藥間隔以及顯著較慢的液體再蓄積，這是該類別的首例。

When all other anti-VGEF agents were compared to EYLEA and head-to-head studies, these agents did not demonstrate slow fluid reclamation.

當所有其他抗 VGEF 藥物與 EYLEA 和頭對頭研究進行比較時，這些藥物並未表現出緩慢的液體回收。

The safety profile of EYLEA HD has continued to be similar to EYLEA through three years and remain generally consistent with the known set profile of EYLEA HD in its pivotal trials.

三年來，EYLEA HD 的安全性一直與 EYLEA 相似，並且與 EYLEA HD 在其關鍵試驗中已知的設定總體保持一致。

Altogether, these data support our belief that our EYLEA HD has a best-in-class profile.

總而言之，這些數據支持了我們的信念：我們的 EYLEA HD 擁有一流的配置。

Now moving to DUPIXENT, which achieved several first and only clinical and regulatory milestones since our second quarter earnings call in early August.

現在轉向 DUPIXENT，自 8 月初的第二季財報電話會議以來，該公司實現了幾個第一個也是唯一的臨床和監管里程碑。

First, we are pleased to receive US regulatory approval for DUPIXENT as an add-on maintenance treatment of adult patients with inadequately controlled COPD and the eosinophilic phenotype marking the first ever biologic approved to treat this disease and represent to PIX 6 indications approved in the United States.

首先，我們很高興獲得美國監管機構批准DUPIXENT 作為COPD 控制不充分的成年患者的附加維持治療，嗜酸性粒細胞表型標誌著第一個被批准用於治療這種疾病的生物製劑，並代表了美國批准的PIX 6 適應症國家。

Also in COPD, as Leon mentioned, we're looking forward to pivotal results in the second half of next year for idapicumab, our interleukin-33 antibody.

同樣在慢性阻塞性肺病方面，正如 Leon 所提到的，我們期待明年下半年我們的白細胞介素 33 抗體 idapicumab 取得關鍵結果。

If approved in the United States, EU and Japan, itepekimab could address approximately 1 million former smokers with COPD regardless of ectopic phenotypes.

如果在美國、歐盟和日本獲得批准，itepekimab 可以治療約 100 萬名患有慢性阻塞性肺病的前吸菸者，無論其異位表型為何。

In terms of potential future indications for DUPIXENT, the Phase III DET trial in moderate to severe bullous pemphigoid patients met the primary and all key secondary endpoints.

就 DUPIXENT 未來的潛在適應症而言，針對中度至重度大皰性類天皰瘡患者的 III 期 DET 試驗滿足了主要終點和所有關鍵次要終點。

Five time more Dupixent patients achieved sustained disease remission at 36 weeks compared to those on placebo.

與服用安慰劑的患者相比，Dupixent 患者在 36 週時獲得持續疾病緩解的患者數量增加了五倍。

DUPIXENT patients were far less likely than patients on placebo to relapse following steroid taper or need rescue therapy during the treatment period.

與服用安慰劑的患者相比，DUPIXENT 患者在類固醇逐漸減少後復發或在治療期間需要挽救治療的可能性要小得多。

Based on these data, DUPIXENT is the first and only biologic to achieve significant improvements in disease remission and symptoms in listened is the first medicine to show significant steroid sparing in this disease.

基於這些數據，DUPIXENT 是第一個也是唯一一個在疾病緩解和症狀方面取得顯著改善的生物製劑，也是第一個在這種疾病中顯示出顯著節省類固醇的藥物。

We anticipate this Phase III ADEPT trial will support regulatory approvals around the world with the U.S. supplementary BLA submission expected by the end of the year.

我們預計該 III 期 ADEPT 試驗將支持世界各地監管機構的批准，預計今年底提交美國補充 BLA。

We also announced results of a second Phase III study of DUPIXENT in biologic-naive patients with chronic spontaneous or ceria, or CSU, confirming the results of a prior Phase III study in the same population.

我們也發表了DUPIXENT 的第二項III 期研究的結果，該研究的對像是患有慢性自發性或二氧化鈰或CSU 的未接受過生物製劑治療的患者，證實了先前在同一人群中進行的III 期研究的結果。

In this most recent study, treatment with DUPIXENT met the primary endpoint and in addition, resulted in a nearly 50% reduction in inch and the carrier activity citim baseline with 30% of DUPIXENT treated patients reporting a complete response or no carrier by week 24 compared to only 18% of those on placebo.

在這項最新研究中，DUPIXENT 治療達到了主要終點，此外，與相比，英寸和載體活動 citim 基線降低了近 50%，其中 30% 的 DUPIXENT 治療患者在第 24 週報告完全緩解或沒有載體。安慰劑組中只有18% 的人出現這種情況。

These data, along with the data generated in the first CSU study evaluating biologically naive patients supported our supplementary BLA resubmission earlier this month, and we look forward to a potential FDA approval early next year which would mark the first targeted therapy for CSU in a decade.

這些數據以及評估生物學上未接受過治療的患者的第一項CSU 研究中產生的數據支持了我們本月早些時候重新提交的補充BLA，我們期待明年初FDA 的潛在批准，這將標誌著CSU 十年來的第一個標靶治療。

Moving to oncology, starting with Libtayo, which provides a best-in-class foundation for combinations with our other oncology assets.

轉向腫瘤學，從 Libtayo 開始，它為與我們其他腫瘤學資產的組合提供了一流的基礎。

At the World Conference on Lung Cancer, we announced five-year results from the final prespecified overall survival analysis of the Phase III EMPOWER LNG 1 trial, which evaluated the entire monotherapy as a first-line treatment for adults with advanced non-small cell lung cancer with more than 50% PD-L1 expression.

在世界肺癌大會上，我們宣布了 III 期 EMPOWER LNG 1 試驗的最終預先指定總體生存分析的五年結果，該試驗評估了整個單一療法作為晚期非小細胞肺成人患者的一線治療PD-L1 表達超過50% 的癌症。

The late-breaking data showed that at five years, Libtayo monotherapy nearly doubled median overall survival and reduced the risk of death by 41% compared to chemotherapy.

最新數據顯示，五年後，與化療相比，Libtayo 單藥治療使中位總存活率幾乎翻倍，死亡風險降低了 41%。

There were also no new safety signals observed their five years among those patients.

五年來，在這些患者中也沒有觀察到新的安全訊號。

These five-year outcomes data in advanced non-small cell lung cancer compare favorably cross trial to other PD-1 or PD-L1 antibodies and further support Libtayo's position as the anti-PD-1 backbone for Regeneron's ongoing oncology efforts.

這些晚期非小細胞肺癌的五年結果數據與其他 PD-1 或​​ PD-L1 抗體的交叉試驗相比較，進一步支持 Libtayo 作為 Regeneron 正在進行的腫瘤學工作的抗 PD-1 支柱的地位。

Moving on to one such Libtayo combination.

繼續討論這樣一種 Libtayo 組合。

At the recent ESMO meeting, we presented updated results of alafeanumab, or lag antibody in combination with Libtayo in adults with advanced melanoma across three independent expansion cohorts of our first-in-human multi-CAR trial.

在最近的 ESMO 會議上，我們在首次人體多 CAR 試驗的三個獨立擴展隊列中展示了 alafeanumab 或滯後抗體與 Libtayo 聯合治療晚期黑色素瘤成人患者的最新結果。

With longer follow-up, these latest results showed persistent and deepening tumor responses across all cohorts.

經過更長時間的隨訪，這些最新結果顯示所有隊列中的腫瘤反應持續且加深。

In a post hot pooled analysis, 50% -- 57% of patients responded with 25% of these patients achieving a complete response.

在熱合併後分析中，50% - 57% 的患者有反應，其中 25% 的患者達到完全反應。

Median progression-free survival was 24 months.

中位無惡化存活期為 24 個月。

Median OS was not reaching any of the individual cohorts on when the results were pooled.

在匯總結果時，中位 OS 並未達到任何單一佇列。

These fianlimab-libtayo proof-of-concept data showed nearly double the complete response rate with more than 5 times greater median PS than previously reported for anti-PD-1 monotherapies.

這些 fianlimab-libtayo 概念驗證數據顯示，與先前報導的抗 PD-1 單一療法相比，完全緩解率幾乎翻倍，中位 PS 高出 5 倍以上。

The fianlimab-libtayo combination also showed robust clinical activity in subpopulations where there is currently no established standard of care, such as in patients previously treated with the anti-PD-1 therapy in the adjuvant or neoadjuvant setting.

fianlimab-libtayo 組合在目前尚無既定護理標準的亞人群中也表現出強大的臨床活性，例如先前在輔助或新輔助環境中接受過抗 PD-1 治療的患者。

Of the 13 patients in this subgroup, 6 patients or 46% response to therapy.

在該亞組的 13 名患者中，有 6 名患者或 46% 對治療有反應。

Among patients receiving any adjuvant or neoadjuvant systemic therapy 11 of 23 or 48% respond to the therapy, including six complete responses.

在接受任何輔助或新輔助全身治療的患者中，23 名患者中的 11 名或 48% 對治療有反應，其中 6 名完全反應。

The safety profile of the fianlimab-libtayo combination was generally consistent with the safety profile of the libtayo monotherapy and other anti-PD-1 agents, except for higher rates of treatment-related adrenal insufficiency.

fianlimab-libtayo 組合的安全性總體上與 libtayo 單藥治療和其他抗 PD-1 藥物的安全性一致，但治療相關的腎上腺功能不全的發生率較高。

Ever since the exciting early data with individual checkpoint inhibitors were presented more than a decade ago, it's been widely hypothesized that combining multiple classes of checkpoint inhibitors might meaningfully enhance antitumor activity without exacerbating safety issues.

自從十多年前公佈了有關單獨檢查點抑制劑的令人興奮的早期數據以來，人們廣泛假設組合多種類型的檢查點抑制劑可能會有意義地增強抗腫瘤活性，而不會加劇安全問題。

We have progress to date has been broadly disappointed.

迄今為止我們所取得的進展普遍令人失望。

We believe the results generated so far in advanced melanoma for fianlimab and Libtayo suggests it might be the first checkpoint inhibitor combination to demonstrate meaningful additive clinical benefit without significantly exacerbating safety.

我們相信，迄今為止，fianlimab 和 Libtayo 在晚期黑色素瘤中產生的結果表明，它可能是第一個在不顯著惡化安全性的情況下證明有意義的附加臨床益處的檢查點抑制劑組合。

Our ongoing randomized Phase III trial of the fianlimab-libtayo versus [pembrolizumab] monotherapy in preciously treated, unresectable, locally advanced or metastatic melanoma is ongoing with pivotal data expected to read next year.

我們正在進行 fianlimab-libtayo 與 [pembrolizumab] 單藥治療治療珍貴治療、不可切除、局部晚期或轉移性黑色素瘤的隨機 III 期試驗，預計將於明年公佈關鍵數據。

In addition to melanoma, we're exploring this combination in a variety of other cancer settings that have historically been responsive to anti-PD-1 therapy, including lung cancer, initial Phase II data for which are expected to read out under this year.

除了黑色素瘤之外，我們還在歷史上對抗 PD-1 療法有反應的各種其他癌症環境中探索這種組合，包括肺癌，其初始 II 期數據預計將在今年公佈。

Next, to our bispecifics for hematology oncology.

接下來是我們用於血液腫瘤學的雙特異性藥物。

We are pleased that the European Commission approved Ordspono or odronextamab, or CD20xCD3 bispecific for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, marking the first regulatory approval of our bispecific antibody platform.

我們很高興歐盟委員會批准Ordspono 或odronextamab 或CD20xCD3 雙特異性藥物用於治療復發/難治性濾泡性淋巴瘤和瀰漫性大B 細胞淋巴瘤，這標誌著我們的雙特異性抗體平台首次獲得監管機構批准。

We continue to work on enrollment of our confirmatory studies to support resubmission of our BLA for follicular lymphoma, which we now expect to even in the first half of 2025.

我們繼續努力招募驗證性研究，以支持重新提交濾泡性淋巴瘤 BLA，我們現在預計甚至在 2025 年上半年完成。

Linvoseltamab are BCMAxCD3 bispecific for myeloma, data from the ongoing linker MM1 study in patients with relapsed/refractory myeloma continue to mature with responses continuing to do recall that 14 months of median follow-up among 117 patients, linvoseltamab continues to demonstrate a potentially best-in-class profile in terms of efficacy, safety, dosing as well as hospitalization burden with 71% of patients respond to therapy and 50% achieving a complete response or better.

Linvoseltamab 是針對骨髓瘤的BCMAxCD3 雙特異性藥物，來自正在進行的複發/難治性骨髓瘤患者的接頭MM1 研究的數據繼續成熟，反應繼續回想起，在117 名患者中進行的14 個月的中在位追蹤中，linvoseltamab 繼續證明了潛在的​​最佳-在療效、安全性、劑量以及住院負擔方面均處於同類水平，71% 的患者對治療有反應，50% 的患者達到完全緩解或更好。

Perhaps the most differentiating about our clinical development program for both our [danexinab] and linvoseltamab, in earlier line settings is our plan to evaluate each agent as monotherapy as well as in limited combinations.

也許我們的 [danexinab] 和 linvoseltamab 臨床開發計劃在早期的生產線設置中最與眾不同的是我們計劃評估每種藥物的單一療法以及有限的組合療法。

While competing -- can bispecifics are evaluating combinations with linvoseltamab and plus rituximab in first-line follicular lymphoma regardless of tumor burden, our Phase II OLYMPIA 1 study is evaluating [agenexinib] monotherapy compared to R-CHOP.

儘管競爭性雙特異性藥物正在評估一線濾泡性淋巴瘤中與linvoseltamab 和加利妥昔單抗的聯合治療（無論腫瘤負荷如何），但我們的II 期OLYMPIA 1 研究正在評估[agenexiib] 單一療法與R-CHOP 的比較。

Similarly, in first-line multiple myeloma, our ongoing Phase I/II linker MM4 study is available in linvoseltamab monotherapy.

同樣，在一線多發性骨髓瘤中，我們正在進行的 I/II 期接頭 MM4 研究可用於 linvoseltamab 單藥治療。

Furthermore, we are also conducting Phase II studies for livosemuab monotherapy in precursor conditions such as smoldering myeloma and monoclonal gammopathy of undetermined significance or MGUs in an attempt to prevent progression to myeloma.

此外，我們也正在進行針對先兆病症（例如冒煙性骨髓瘤和意義未明的單克隆丙種球蛋白病或 MGU）的 livosemuab 單藥治療的 II 期研究，以試圖預防進展為骨髓瘤。

Now to our non-oncology hematology pipeline, starting with our C5 program, which is the first combination of an antibody and siRNA that targets the same protein.

現在我們的非腫瘤血液學管道，從我們的 C5 計畫開始，這是針對相同蛋白質的抗體和 siRNA 的第一個組合。

We expect to present updated results for one potential indication paroxysmal, maternal hemoglobinuria later this year and expect to read out pivotal results and generalize myelogenic graphs in the second half of next year.

我們預計將在今年稍後提出陣發性母體血紅蛋白尿這一潛在適應症的最新結果，並預計在明年下半年讀出關鍵結果並概括骨髓生成圖。

We also initiated our Phase III program in geographic atrophy in dry age-related macro degeneration with initial patient screening now underway.

我們也啟動了針對乾性老年性宏觀退化的地理萎縮的 III 期項目，目前正在進行初步患者篩檢。

We believe that our systemic approach has several significant advantages over currently approved agents.

我們相信，我們的系統方法比目前核准的藥物有幾個顯著的優勢。

First, it may avoid the risk of rare but severe eye inflammation irreversible vision loss that has been observed with currently approved intravitreal treatments.

首先，它可以避免在目前批准的玻璃體內治療中觀察到的罕見但嚴重的眼部發炎和不可逆的視力喪失的風險。

And our systemic approach is the potential to offer convenient treatment of bilateral disease as well.

我們的系統方法也有可能為雙側疾病提供便捷的治療。

Regarding our Factor XI antibodies, we remain on track to report top line results by year-end of our proof-of-concept studies for our A2 domain targeting and our catalytic domain targeting antibodies in the setting of prevention of venous thromboembolism following the new replacement surgery.

Regarding our Factor XI antibodies, we remain on track to report top line results by year-end of our proof-of-concept studies for our A2 domain targeting and our catalytic domain targeting antibodies in the setting of prevention of venous thromboembolism following the new replacement手術.

Results of these studies will inform whether to proceed to registration-enabling studies with one or both of these antibodies with the possibility that both antibodies will advance to Phase III, but in different thrombosis indications or in patient different biotin populations.

這些研究的結果將決定是否對這些抗體中的一種或兩種進行註冊研究，兩種抗體有可能進入 III 期，但適用於不同的血栓形成適應症或患者不同的生物素群體。

In summary, we continue to drive forward our innovative development pipeline and anticipate reading out several pivotal concept data sets in oncology, immunology, obesity hematology and genetic medicines over the next 12 to 18 months while our early research engine has never been more productive with multiple novel programs potentially advancing into the clinic over the same time frame.

總之，我們將繼續推進我們的創新開發管道，並預計在未來12 至18 個月內讀出腫瘤學、免疫學、肥胖血液學和遺傳醫學方面的幾個關鍵概念數據集，而我們的早期研究引擎從未如此高效，擁有多個新穎的項目有可能在同一時間範圍內進入臨床。

And with that, I will turn the call over to Marion.

接下來，我會將電話轉給馬里昂。

Thank you, George.

謝謝你，喬治。

Our third quarter performance demonstrates Regeneron's ongoing leadership across therapeutic categories.

我們第三季的業績證明了再生元在治療領域的持續領先地位。

We continue to advance the strength and diversity of our product portfolio.

我們持續提高產品組合的實力和多樣性。

And as George described, our pipeline is advancing with several potential regulatory filings and approvals on the horizon, creating both near and longer-term opportunities.

正如喬治所描述的，我們的管道正在推進，即將有幾項潛在的監管備案和批准，創造了近期和長期的機會。

I'll begin with EYLEA HD and EYLEA.

我將從 EYLEA HD 和 EYLEA 開始。

In the third quarter, combined US net sales were $1.54 billion, a 3% year-over-year increase.

第三季度，美國淨銷售額合計為 15.4 億美元，較去年同期成長 3%。

EYLEA HD and EYLEA net sales were favorably impacted by approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD at the end of the third quarter partially offset by lower inventory levels for EYLEA.

由於第三季末 EYLEA HD 批發商庫存水準較高，部分被 EYLEA 庫存水準較低所抵消，EYLEA HD 和 EYLEA 淨銷售額受到約 4,000 萬美元的有利影響。

As a result, we expect fourth quarter EYLEA HD net sales to be negatively impacted as this increase in wholesaler inventory is absorbed.

因此，我們預計第四季度 EYLEA HD 淨銷售額將受到負面影響，因為批發商庫存的增加被吸收。

Together, EYLEA HD and EYLEA captured 44% of the total anti-VEGF category in the third quarter, demonstrating retina specialists experience and confidence in both brands.

第三季度，EYLEA HD 和 EYLEA 合計佔抗 VEGF 類別總量的 44%，展現了視網膜專家的經驗和對這兩個品牌的信心。

EYLEA HD net sales grew 29% sequentially in the quarter to $392 million, driven by ongoing adoption across treatment experienced and treatment-naive patients as treatment Experience grows retina specialists reporting to EYLEA HD's durability, coupled with its efficacy and safety as important clinical differentiators.

EYLEA HD 本季淨銷售額環比增長29%，達到3.92 億美元，這是由於治療經驗不斷增長，視網膜專家將EYLEA HD 的耐用性、有效性和安全性作為重要的臨床差異化因素，在有治療經驗和未接受過治療的患者中持續採用，從而推動了EYLEA HD 的淨銷售額成長。

Recent late-breaking data presented at American Academy of Ophthalmology's annual meeting highlighted EYLEA HD's potential best-in-class profile.

美國眼科學會年會上公佈的最新數據凸顯了 EYLEA HD 潛在的同類最佳特徵。

As George highlighted, diabetic macular edema patients who switched to EYLEA HD consistently achieved longer dosing intervals and slower retinal fluid reaccumulation.

正如 George 所強調的那樣，改用 EYLEA HD 的糖尿病黃斑水腫患者始終能夠實現更長的給藥間隔和更慢的視網膜液體再積聚。

While we anticipate the anti-VEGF category to continue to be highly competitive with both branded and biosimilar products in the marketplace, we plan to further strengthen the EYLEA HD product profile through the anticipated launch of our differentiated prefilled syringe by mid-2025 and a potential approval of the RVO indication, which is registration-enabling data are expected by the end of this year.

雖然我們預計抗 VEGF 類別將繼續與市場上的品牌產品和生物仿製藥產品競爭激烈，但我們計劃透過預計在 2025 年中期推出我們的差異化預充式註射器以及潛在的RVO 適應症預計將在今年年底獲得批准，這是可註冊的數據。

In the first year since launch, positive physician and patient experience has propelled EYLEA HD to achieve billion-dollar brand status.

自推出以來的第一年，積極的醫生和患者體驗推動 EYLEA HD 達到了十億美元的品牌地位。

With additional growth catalysts expected in 2025, our team is focused on helping even more patients benefit from EYLEA HD.

預計 2025 年將出現更多成長催化劑，我們的團隊致力於幫助更多患者從 EYLEA HD 中受益。

Turning to Libtayo.

轉向利布塔約。

We continue to make significant progress in the third quarter with global net sales increasing 24% year-over-year on a constant currency basis to $289 million the US net sales grew 35% to $195 million in non-melanoma skin cancer, our work to expand the immunotherapy market has resulted in an even greater number of Libtayo patients.

我們在第三季持續取得重大進展，以固定匯率計算，全球淨銷售額年增24%，達到2.89 億美元，美國非黑色素瘤皮膚癌淨銷售額成長35%，達到1.95 億美元，我們的工作是免疫療法市場的擴大導致了更多的 Libtayo 患者。

And in lung cancer, we continue to gain market share.

在肺癌領域，我們繼續獲得市場份額。

Outside the US, net sales were $94 million, which does not include $20 million in distributor purchases that shifted to the fourth quarter.

美國以外地區的淨銷售額為 9,400 萬美元，其中不包括轉移至第四季度的 2,000 萬美元分銷商採購。

We continue to see opportunities to increase Libtayo demand in 2025 with new launches in several markets.

我們繼續看到 2025 年 Libtayo 需求增加的機會，在多個市場推出新產品。

And finally, to DUPIXENT, which continues its remarkable growth trajectory.

最後是 DUPIXENT，它繼續保持驚人的成長軌跡。

In addition to the positive data readouts and regulatory updates that George mentioned, we've reached an impressive milestone.

除了喬治提到的積極的數據讀數和監管更新之外，我們還達到了一個令人印象深刻的里程碑。

DUPIXENT has now surpassed 1 million patients on therapy across seven indications worldwide.

DUPIXENT 現已在全球接受超過 100 萬名患者的七種適應症治療。

In the quarter, DUPIXENT achieved global net sales of $3.8 billion, a 24% year-over-year increase on a constant currency basis, driven by uptake across all indications, age groups and geographies.

本季度，DUPIXENT 的全球淨銷售額達到 38 億美元，以固定匯率計算年增 24%，這得益於所有適應症、年齡組和地區的吸收。

In the US, net sales grew 19% year over year to $2.8 billion, and DUPIXENT continues to be the number one prescribed biologic for new-to-brand patients in all of its approved indications.

在美國，淨銷售額年增 19%，達到 28 億美元，DUPIXENT 繼續成為新品牌患者在其所有核准適應症中排名第一的處方生物製劑。

It's widely recognized by prescribers that DUPIXENT's differential dual mechanism of action targeting IL-4 and IL-13 addresses the underlying cause of these type 2 diseases.

處方醫生廣泛認識到，DUPIXENT 針對 IL-4 和 IL-13 的差異雙重作用機制解決了這些 2 型疾病的根本原因。

Demand is strong across the blockbuster indications of atopic dermatitis, asthma and nasal polyps, and there is opportunity for ongoing market penetration based on unmet patient need.

異位性皮膚炎、氣喘和鼻息肉等重磅適應症的需求強勁，並且基於未滿足的患者需求，存在持續市場滲透的機會。

Uptake is also increasing across our recent US launches, new-to-brand prescriptions for prurigo nodularis are up approximately 30% compared to the prior year and EOE new-to-brand prescriptions, including the pediatric indication, are up approximately 40%.

我們最近在美國推出的產品的使用率也在增加，結節性癢疹的新品牌處方量比前一年增加了約 30%，EOE 新品牌處方藥（包括兒科適應症）增加了約 40%。

In September, DUPIXENT's label was expanded to include patients as young as 12 years of age who have inadequately controlled chronic rhinosinusitis with nasal polyps, and we estimate approximately 9,000 additional US patients can now benefit from DUPIXENT.

9 月份，DUPIXENT 的標籤範圍擴大到包括年僅 12 歲、伴有鼻息肉的慢性鼻竇炎控制不佳的患者，我們估計大約還有 9,000 名美國患者現在可以從 DUPIXENT 中受益。

In recent months, DUPIXENT has been approved to treat COPD in more than 30 countries.

近幾個月來，DUPIXENT已在30多個國家被批准用於治療慢性阻塞性肺病。

We are excited about the opportunity to extend DUPIXENT's leadership in respiratory KR, which we estimate may benefit more than 300,000 patients in the US alone with inadequately controlled COPD and an eosinophilic phenotype.

我們很高興有機會擴大 DUPIXENT 在呼吸 KR 領域的領先地位，我們估計僅在美國就有超過 300,000 名 COPD 控制不充分和嗜酸性粒細胞表型的患者受益。

In the first weeks of the US launch, we've been encouraged by the enthusiasm from physicians and patients for DUPIXENT as a treatment option in this underserved population.

在美國上市的頭幾週，醫生和患者對 DUPIXENT 作為這一服務不足人群的治療選擇的熱情令我們深受鼓舞。

Educational efforts are underway to highlight the importance of type 2 inflammation in COPD and supporting patient identification by prescribers and motivating patients to speak with their physician about DUPIXENT.

目前正在進行教育工作，以強調 2 型發炎在 COPD 中的重要性，並支持處方者識別患者並鼓勵患者與醫生討論 DUPIXENT。

We've made significant progress in securing access and reimbursement for patients, many of whom are covered under Medicare.

我們在確保患者獲得醫療服務和報銷方面取得了重大進展，其中許多患者都享有醫療保險。

With DUPIXENT's unique clinical profile and first biologic to market advantage, we anticipate the COPD indication will drive meaningful growth for DUPIXENT.

憑藉 DUPIXENT 獨特的臨床特徵和第一個生物製劑上市的優勢，我們預計 COPD 適應症將推動 DUPIXENT 的有意義的成長。

In summary, DUPIXENT continues to transform standard of care in lives of patients worldwide.

總之，DUPIXENT 繼續改變全世界病患生活的照護標準。

In addition to current approvals, we look forward to future potential launches in diseases, including COPD in Japan, pediatric EOE in the EU, and chronic spontaneous urticaria in the US, as well as global regulatory filings for bullous pemphigoid.

除了目前的批准外，我們還期待未來可能在疾病領域上市，包括日本的慢性阻塞性肺病、歐盟的兒科 EOE 和美國的慢性自發性蕁麻疹，以及大皰性類天皰瘡的全球監管申請。

In conclusion, our commercial team continues to deliver on our goal to provide Regeneron medicines to an ever-expanding number of patients worldwide.

總之，我們的商業團隊將繼續實現我們的目標，為全球不斷增加的患者提供再生元藥物。

There is significant growth potential within the current and future indications of our medicines and our pipeline provides meaningful opportunities for growth.

我們的藥物當前和未來的適應症具有巨大的成長潛力，我們的管道提供了有意義的成長機會。

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

這樣，我會將電話轉給克里斯。

Thank you, Marion.

謝謝你，馬里昂。

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

除非另有說明，我今天對再生元財務表現和前景的評論將基於非公認會計原則。

Regeneron delivered strong financial performance in the third quarter with continued execution driving top and bottom-line growth.

再生元在第三季度實現了強勁的財務業績，持續的執行力推動了營收和利潤的成長。

Total revenues increased 11% year over year to $3.7 billion, primarily driven by higher Sanofi collaboration revenue, continued growth for Libtayo and US growth of total EYLEA HD and EYLEA.

總營收年增 11%，達到 37 億美元，主要是由於賽諾菲合作收入增加、Libtayo 持續成長以及 EYLEA HD 和 EYLEA 在美國的總收入成長。

Third-quarter net income per share grew 8% from the prior year to $12.46 on net income of $1.5 billion. Third-quarter

第三季每股淨利較上年同期成長 8%，達到 12.46 美元，淨利為 15 億美元。第三季

revenues from our Sanofi collaboration were $1.3 billion inclusive of $1.1 billion related to our share of collaboration profits.

我們與賽諾菲的合作帶來的收入為 13 億美元，其中包括與我們的合作利潤份額相關的 11 億美元。

Regeneron's share of profits grew 26% versus the prior year driven by volume growth for DUPIXENT and improving collaboration margins, with collaboration profitability reaching another all-time high in the third quarter.

在 DUPIXENT 銷售成長和協作利潤提高的推動下，Regeneron 的利潤份額較上年增長了 26%，協作盈利能力在第三季度再創歷史新高。

The Sanofi development balance was approximately $1.8 billion at the end of the third quarter, reflecting a reduction of approximately $200 million from the end of the second quarter and approximately $520 million from the end of 2023.

截至第三季末，賽諾菲開發餘額約18億美元，較第二季末減少約2億美元，較2023年底減少約5.2億美元。

Moving to Bayer.

搬到拜耳。

Third quarter ex-US net sales of EYLEA and EYLEA 8 mg were $932 million, up 9% on a constant currency basis versus the prior year.

第三季 EYLEA 和 EYLEA 8 mg 在美國以外的淨銷售額為 9.32 億美元，以固定匯率計算比上年增長 9%。

Total buyer collaboration revenue was $391 million, of which $368 million related to our share of net profits outside the US.

買家合作總收入為 3.91 億美元，其中 3.68 億美元與我們在美國以外的淨利潤份額有關。

We recorded $35 million of sales for Inmazeb, our antibody cocktail for Ebola in the third quarter related to deliveries to the US government under our existing agreement.

我們第三季針對伊波拉病毒的抗體混合物 Inmazeb 的銷售額為 3500 萬美元，與根據我們現有協議向美國政府交付有關。

We still expect 2024 Inmazeb sales to be in line with 2023 sales of approximately $70 million.

我們仍預期 2024 年 Inmazeb 的銷售額將與 2023 年約 7,000 萬美元的銷售額持平。

Other revenue in the third quarter was $114 million.

第三季其他收入為1.14億美元。

We expect other revenue will increase sequentially in the fourth quarter of 2024, but on a full year basis, is expected to be lower than 2023.

我們預計其他收入將在 2024 年第四季環比成長，但從全年來看，預計將低於 2023 年。

Now to our operating expenses.

現在我們的營運費用。

R&D expense was $1.1 billion in the third quarter.

第三季研發費用為11億美元。

The increase in R&D expense versus the prior year was driven by ongoing investments in our pipeline, including late-stage oncology programs and increased clinical manufacturing costs to support ongoing programs.

研發費用與前一年相比的增加是由於我們管道的持續投資，包括後期腫瘤學計畫和支持正在進行的計畫的臨床製造成本增加。

SG&A grew 15% from the prior year to $613 million in the third quarter, primarily reflecting ongoing investment to support the launch of EYLEA HD.

第三季銷售、管理及行政費用比上年同期成長 15%，達到 6.13 億美元，主要反映了為支持 EYLEA HD 推出而進行的持續投資。

Third-quarter 2024 gross margin on net product sales declined to 89% compared to 90% in the prior year, primarily reflecting higher start-up costs for our fill/finish manufacturing facility.

2024 年第三季產品淨銷售毛利率下降至 89%，而前一年為 90%，主要反映了我們的灌裝/成品製造廠的啟動成本較高。

Now to cash flow and the balance sheet.

現在來看看現金流量和資產負債表。

Regeneron generated approximately $2.6 billion in free cash flow through the first nine months of 2024 and ended the quarter with cash and marketable securities less debt of approximately $15.6 billion.

Regeneron 在 2024 年前 9 個月產生了約 26 億美元的自由現金流，本季末現金和有價證券減去債務約為 156 億美元。

Through the first nine months of 2024, we have repurchased over $1.6 billion of our shares, including $738 million in the third quarter.

截至 2024 年前 9 個月，我們回購了超過 16 億美元的股票，其中第三季回購了 7.38 億美元。

Given our long-term growth potential, we continue to see share repurchases as an efficient use of capital and had approximately $2.9 billion available for repurchases as of the end of the third quarter.

鑑於我們的長期成長潛力，我們繼續將股票回購視為資本的有效利用，截至第三季末，可用於回購的資金約為 29 億美元。

Finally, we made some minor changes to our full year 2021 financial guidance based on our year-to-date results, narrowing ranges across most guidance items.

最後，我們根據年初至今的業績對 2021 年全年財務指引進行了一些細微調整，縮小了大多數指引項目的範圍。

A complete summary of our latest full year 2024 guidance is available in our press release issued earlier this morning.

今天早上早些時候發布的新聞稿中提供了我們最新的 2024 年全年指導的完整摘要。

In summary, Regeneron delivered strong financial results in the third quarter, and our focused investments continue to position us to drive long-term growth.

總之，再生元在第三季取得了強勁的財務業績，我們的重點投資繼續使我們能夠推動長期成長。

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

這樣，我會將電話轉回給 Ryan。

Thank you, Chris.

謝謝你，克里斯。

This concludes our prepared remarks.

我們準備好的演講到此結束。

We will now open the call for Q&A.

我們現在將開始問答徵集。

(Operator Instructions).

（操作員說明）。

Shannon, can we please go into our first question.

香農，我們可以回答第一個問題嗎？

(Operator Instructions) Chris Schott, JPMorgan.

（操作員指示）Chris Schott，摩根大通。

This is Taylor Hanley on for Chris Schott.

我是泰勒漢利 (Taylor Hanley)，替克里斯肖特 (Chris Schott) 發言。

We just had a question on EYLEA.

我們剛剛有一個關於 EYLEA 的問題。

So with Alnylam launching their biosimilar, how are you thinking about EYLEA going forward?

隨著 Alnylam 推出生物相似藥，您對 EYLEA 的未來有何看法？

And what levels can you pull to potentially accelerate conversion to high-dose EYLEA?

您可以達到什麼水平才能加速向高劑量 EYLEA 的轉換？

And how are you thinking about pricing for the franchise more broadly?

您如何考慮更廣泛的特許經營定價？

So Mary may have some extra comments on that.

所以瑪麗可能對此有一些額外的評論。

But look, EYLEA is a fantastic product.

但你看，EYLEA 是一款非常棒的產品。

We have delivered probably somewhere in the neighborhood of around $100 million or more injections with EYLEA.

我們已經透過 EYLEA 進行了大約 1 億美元或更多的注射。

And so the performance and safety of the product, our transparency with safety issues that may arise over the past decade, I think, has given physicians and their patients, a lot of comfort with EYLEA, and you see some stickiness of that product.

因此，我認為，產品的性能和安全性，以及我們對過去十年中可能出現的安全問題的透明度，讓醫生及其患者對 EYLEA 感到非常放心，並且您會看到該產品的一些粘性。

Nonetheless, we think that EYLEA HD is a differentiated product, and we are continuing to work on using the standard approaches of education and informing the doctors about the potential use in patients, providing them with more data, as George referred to, some of the long-term data is rather striking.

儘管如此，我們認為EYLEA HD 是一款差異化產品，我們正在繼續致力於使用標準的教育方法，並向醫生通報其在患者中的潛在用途，為他們提供更多數據，正如George 所提到的，一些長期數據相當驚人。

We know that there is a biosimilar in the market for EYLEA, not for EYLEA HD, and we know it will be competitive, but we think we'll be able to compete well.

我們知道市場上有 EYLEA 的生物相似藥，而不是 EYLEA HD，我們知道它將具有競爭力，但我們認為我們將能夠很好地競爭。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

Maybe we'll come back to Evan.

也許我們會回到埃文。

Shannon, why don't we go to the next.

香農，我們為什麼不去下一個呢？

Tyler Van Buren, TD Cowen.

泰勒·範布倫，TD·考恩。

Congrats on the quarterly results and all the progress.

恭喜季度業績和所有進展。

Can you reiterate your confidence in EYLEA HD quarter-over-quarter growth going into Q4 despite the negative impact due to wholesaler inventory?

儘管批發商庫存造成了負面影響，您能否重申您對 EYLEA HD 進入第四季度環比增長的信心？

And are you seeing a tailwind with the overall franchise yet due to the removal of product from a major supplier of linvoseltamab?

由於林沃司他單抗主要供應商取消了產品，您是否看到了整個特許經營權的順風車？

So let me take both of those, Tyler.

所以讓我把這兩個都拿走，泰勒。

First, as I described to you the performance in the quarter showed growth for EYLEA and EYLEA HD?

首先，正如我向您描述的，該季度的業績顯示 EYLEA 和 EYLEA HD 有所增長？

And then more specifically to your comment related to EYLEA HD, we have very strong confidence in the product profile, the interest of the retina community, the quality of our safety, clinical data durability are all being seen.

然後更具體地說，對於您對 EYLEA HD 的評論，我們對產品概況、視網膜界的興趣、我們的安全品質、臨床數據耐久性都非常有信心。

But I did want to call out that we did see an inventory matter take place in the quarter that I wanted to comment on.

但我確實想指出，我們確實看到我想評論的季度發生了庫存問題。

We're not going to give fourth quarter guidance.

我們不會提供第四季的指導。

But specifically, I wanted to be an awareness related to the favorable impact of approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD.

但具體而言，我希望認識到 EYLEA HD 批發商庫存水準較高所帶來的約 4000 萬美元的有利影響。

At the end of the third quarter, partially offset by wholesaler inventory levels that were lower -- a bit lower on EYLEA.

第三季末，批發商庫存水準較低（EYLEA 略低）部分抵消了這一影響。

So we wanted to share that information, but certainly we have every confidence in EYLEA HD performance, but that inventory obviously will be used in the fourth quarter of this year.

所以我們想分享這些信息，但當然我們對 EYLEA HD 的性能充滿信心，但該庫存顯然將在今年第四季度使用。

Looking forward, Tyler, to next year, I think Mary may have mentioned that bringing our prefilled syringe to market around -- by the middle of the year, I think, will be a nice catalyst for acceleration I think that we've taken a lot of pain to make sure that when we bring something to the market, it's going to withstand the test of millions and millions of injections our competition may have brought something forth that, for example, needs a cloth needle because they must be trying to filter something out, we presume.

展望明年，泰勒，我認為瑪麗可能已經提到，到今年年中，將我們的預充式註射器推向市場，我認為，這將是加速的良好催化劑，我認為我們已經採取了我們付出了很多努力，以確保當我們將某些東西推向市場時，它能夠經受住數百萬次注射的考驗，我們的競爭對手可能會帶來一些東西，例如，需要布針，因為他們必須試圖過濾我們推測，有什麼事發生了。

We are hoping to not have to have that issue and we are looking very carefully to make sure that we bring something that really will not result in inflammation.

我們希望不會有這個問題，我們正在非常仔細地尋找，以確保我們帶來的東西確實不會導致發炎。

Remember that in this marketplace, products have been really killed if you have too much inflammation, which leads to potential for retinal vasculitis and even occlusive retinal vasculitis with loss of vision.

請記住，在這個市場上，如果您有太多炎症，產品就真的被淘汰了，這會導致潛在的視網膜血管炎，甚至閉塞性視網膜血管炎並導致視力喪失。

So we are very sensitive to all that.

所以我們對這一切都非常敏感。

I think doctors will be sensitive to that with any new launch despite biosimilars.

我認為，儘管有生物相似藥，但任何新產品的推出，醫生都會對此敏感。

They're going to probably want to look carefully and they know EYLEA and EYLEA is something I think they can trust in.

他們可能會想仔細看看，他們知道 EYLEA 和 EYLEA 是我認為他們可以信任的。

So we will be methodical about how we do this, and we're in this for the long game.

因此，我們將有條不紊地思考如何做到這一點，並且我們將長期致力於此。

Tyler, I also want to cover your question related to pine and they are coming away from support of Avastin in the marketplace.

泰勒，我還想回答您與松樹相關的問題，他們正在擺脫市場上阿瓦斯汀的支持。

So we're very well aware of that.

所以我們非常清楚這一點。

And certainly, our teams are actively involved in retina offices supporting staff and working with them on any challenges that present I would share that at this point, there still is Avastin inventory from pine in the market.

當然，我們的團隊積極參與視網膜辦公室，為員工提供支持，並與他們合作應對任何挑戰。

I think it's anticipated to run out within a couple of weeks.

我認為預計將在幾週內用完。

So we haven't seen a material uptake in EYLEA HD or EYLEA related to that yet, but we're staying very close to that situation and support to our customers.

因此，我們還沒有看到 EYLEA HD 或 EYLEA 與此相關的實質吸收，但我們非常接近這種情況並為我們的客戶提供支援。

Brian Abrahams, RBC Capital Markets.

布萊恩‧亞伯拉罕斯 (Brian Abrahams)，加拿大皇家銀行資本市場部。

On the HD prefilled syringe, can you talk about the potential inflection in use that, that could catalyze next year, including how the differentiation of that prefilled string might resonate.

關於 HD 預填充注射器，您能否談談使用中可能會催化明年的潛在變化，包括預填充注射器的差異化可能如何產生共鳴。

And maybe also elaborate on some of the gating factors to development there, timeline sounds like they've been pushed out a little bit.

也許還詳細說明了那裡發展的一些限制因素，時間表聽起來像是被推遲了一點。

Yes.

是的。

As I said, we anticipate bringing that to the market by the middle of next year.

正如我所說，我們預計在明年年中將其推向市場。

I believe already or almost immediately, EYLEA will be bringing the same device to the market with EYLEA HD outside of the United States.

我相信 EYLEA 已經或幾乎立即將透過 EYLEA HD 將相同的設備推向美國以外的市場。

So we have a high degree of confidence.

所以我們有高度的信心。

There are some additional requirements that you have to do inside the United States, which we're working through.

您在美國境內還必須滿足一些額外的要求，我們正在解決這些要求。

And as I said, we think we'll have a differentiated product opportunity there.

正如我所說，我們認為我們將在那裡擁有差異化的產品機會。

So you're right, Brian, it's possible that there could be an inflection when that comes to market because there is a preference for the prefilled syringe.

所以你是對的，布萊恩，當進入市場時可能會出現變化，因為人們更喜歡預充式註射器。

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

Maybe for Leonard and Chris, just now in the wake of Amgen potentially being on the market has driven any sort of change in conservative conceptually how you're thinking about the pace of R&D investments going forward or your capital allocation priorities, you're potentially leaning into buybacks or further rolling out or delaying a potential dividend?

也許對於倫納德和克里斯來說，在安進可能上市之後，保守派概念上發生了任何形式的變化，你如何思考未來研發投資的步伐或你的資本分配優先事項，你可能會傾向於回購或進一步推出或延後潛在股利？

Any color on that front would be helpful.

前面的任何顏色都會有幫助。

Well, we're -- they say imitation is the best form of flattery.

嗯，我們——他們說模仿是最好的奉承。

So we're glad to be flattered by Amgen that they're spending their time imitating our products.

因此，我們很高興安進公司花時間模仿我們的產品。

We're spending our money trying to bring new products to market which where we think is what this industry really is built for.

我們正在花錢嘗試將新產品推向市場，我們認為這才是這個產業真正的目的。

It's really not built -- biosimilars are fine, but we think the industry is best built and Regeneron is best built to bring innovative products to market.

它實際上還沒有建成——生物相似藥很好，但我們認為這個行業最好的建設，再生元最好的建設是將創新產品推向市場。

As I mentioned, we have over 40 products in clinical development, many of which are in Phase III.

正如我所提到的，我們有 40 多種產品處於臨床開發階段，其中許多產品處於 III 期。

As George detailed, there are a lot of exciting programs in there with lots of data readouts.

正如喬治所詳述的，其中有許多令人興奮的程序以及大量的數據讀數。

We're not going to gate spending based upon a biosimilar entry, we're going to spend what's appropriate based upon the opportunities that we see.

我們不會根據生物相似藥進入來限制支出，我們將根據我們看到的機會進行適當的支出。

We have a strong balance sheet.

我們擁有強大的資產負債表。

We have good earnings.

我們有很好的收入。

We have the capability to make significant investments.

我們有能力進行重大投資。

And George has built, I think, the most olipic research and development organization in the industry.

我認為，喬治建立了業界最開放的研發組織。

So it would be full hardy not to invest in that, and you'll probably see some investments to go up.

因此，不投資於此是完全困難的，而且您可能會看到一些投資會增加。

The big question in this game always is, will these investments pay off I think our past performance will not guarantee to anything in the future, the more than 10 or 12 products that George and gang have bought market there's a good harbinger of things to come.

這個遊戲中最大的問題始終是，這些投資會得到回報嗎？ 。

And as I said, with more than 40 things in development, we couldn't be more excited about our future product profiles.

正如我所說，有 40 多項產品正在開發中，我們對未來的產品概況感到非常興奮。

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

Great.

偉大的。

I know you have some upcoming factor readouts here before the end of the year.

我知道今年年底前你們將發布一些即將發布的因子讀數。

Maybe you could just tell us what you're looking for to make the decision about whether to advance those into a Phase III program and how you're considering them versus each other and also versus the standard of care.

也許您可以告訴我們您正在尋找什麼來決定是否將這些項目推進到第三階段計劃，以及您如何考慮它們之間的對比以及護理標準。

Yes.

是的。

This is George.

這是喬治。

We're very excited about our Factor XI program because we think it's very different from anything else that's out there. we chose to take a different approach where we attack Factor XI in two different ways, what we call our A2 domain antibody or catalytic domain antibody.

我們對 Factor XI 計劃感到非常興奮，因為我們認為它與現有的任何其他計劃都非常不同。我們選擇採取不同的方法，以兩種不同的方式攻擊因子 XI，我們稱之為 A2 結構域抗體或催化結構域抗體。

Our A2 domain antibody is not a complete blocker of Fact it actually is more like a complete Factor 1 blocker.

我們的 A2 結構域抗體並不是 Fact 的完全阻斷劑，它實際上更像是完全的 Factor 1 阻斷劑。

It's expected to not have as profound effect on the coagulation pathways, but to have a much milder safety profile.

預計它不會對凝血途徑產生那麼深遠的影響，但安全性要溫和得多。

In contrast, we believe that our coagulation domain antibody is the best-in-class blocker of Factor it will come with the best ability to control coagulation among all agents that are attacking this pathway.

相較之下，我們相信我們的凝血域抗體是同類中最好的因子阻斷劑，它將在所有攻擊該途徑的藥物中具有最佳的控制凝血的能力。

But of course, it will also have presumably a higher safety load than our A2 domain antibody.

但當然，它也可能比我們的 A2 域抗體具有更高的安全負荷。

So we think it's very exciting to have these two parallel but very distinguished approaches.

因此，我們認為擁有這兩種並行但又截然不同的方法是非常令人興奮的。

We actually hope to be able to show that both of these substantially controlled thrombo formation in the clinical trials that we now have running.

實際上，我們希望能夠在我們現在正在進行的臨床試驗中證明這兩種方法基本上都能控制血栓形成。

And we hope to then in the future, decide based on how well they each control and their expected safety profile, we expect the ability to consider multiple indications that we can evaluate each one for different potential indications for one versus the other.

我們希望在未來，根據它們各自的控製程度和預期的安全狀況來決定，我們希望能夠考慮多種跡象，以便我們可以評估每種跡象的不同潛在跡象。

So these are sort of a pipeline in and of themselves able to attack, we believe, a variety of different coagulation settings, and each one of them can be used differentially and provide a different profile of efficacy versus safety as might be needed in the different clinical settings.

因此，我們相信，這些本身就是一種管道，能夠攻擊各種不同的凝血設置，並且它們中的每一個都可以有區別地使用，並根據不同的情況可能需要提供不同的功效與安全性。環境。

One second.

一秒鐘。

I just wanted to add to that.

我只是想補充一點。

What George has taught me over the years is that not all antibodies are created equal.

多年來，喬治告訴我的是，並非所有抗體都是一樣的。

And I would not -- not all blockers of the pathway are created equal.

我不會——並非所有阻礙該途徑的因素都是一樣的。

And we have in-house pharmacodynamic data, which suggests that the antibodies that Regeneron has created and selected, we really have a competitive advantage in how we do that outperform other Factor XI antibodies or small molecule competitors.

我們擁有內部藥效學數據，這表明再生元創建和選擇的抗體在優於其他因子 XI 抗體或小分子競爭對手方面確實具有競爭優勢。

Of course, with the small molecule competitors, it's hard to get to the high dose because you have off-target problems.

當然，對於小分子競爭對手來說，很難達到高劑量，因為有脫靶問題。

And with the antibodies, people can't always get the best antibodies.

而有了抗體，人們並不總是可以獲得最好的抗體。

We think we have the technology and these things are not all created equal.

我們認為我們擁有技術，但這些東西並非都是生而平等的。

So the proof of the pudding will be in the meeting when we get the data and see how that performed.

因此，當我們獲得數據並查看其表現時，布丁的證明將在會議上進行。

Chris Raymond, Piper Sandler.

克里斯·雷蒙德，派珀·桑德勒。

Maybe just a follow-up on the last and supply issue with Pine and potentially others exiting the market.

也許只是 Pine 和其他可能退出市場的最後一個供應問題的後續行動。

Maybe just stepping back, compounded Avastin has seen supply and quality issues before.

也許退一步來說，複雜的阿瓦斯丁以前就遇到供應和品質問題。

Do you see this episode as different from prior disruptions?

您認為這事件與先前的中斷有何不同？

We had a KOL tell us that he believes this marks sort of the beginning of the end for Avastin.

一位 KOL 告訴我們，他認為這標誌著阿瓦斯汀終結的開始。

I'd love to hear your thoughts on that.

我很想聽聽你對此的想法。

And maybe as a follow-up, if Avastin is likely to play less of a role here, does this not provide more of an opening for a biosimilar option?

也許作為後續行動，如果阿瓦斯汀可能在這裡發揮較小的作用，這是否不會為生物相似藥的選擇提供更多的機會？

So Chris, let me take the impact and the situation with Pine and say that I think that probably what we're hearing is that because of the prior Avastin shortages last year around this time that the same thing occurred, offices and practices are getting used to how to deal with the situation.

克里斯，讓我來談談 Pine 的影響和情況，我認為我們可能聽到的是，由於去年阿瓦斯汀短缺，大約在這個時候發生了同樣的事情，辦公室和診所正在被使用如何處理這種情況。

And obviously, the confidence in Avastin goes down in the supply.

顯然，人們對阿瓦斯汀的信心隨著供應量的增加而下降。

So certainly, it's important.

所以當然，這很重要。

And I see -- I think the evolution that you're hearing is because it's a situation that has been dealt with before.

我明白了——我認為你所聽到的演變是因為這是一個以前已經處理過的情況。

We certainly want physicians to have choice in prescribing the anti-VEGF category product brand that they think is best for their patients.

我們當然希望醫師可以選擇他們認為最適合患者的抗 VEGF 類別產品品牌。

And certainly, I think it is a competitive marketplace, but as we show in growth of our franchise, this quarter, we did last quarter as well, we certainly think that both EYLEA HD and EYLEA are both positioned very well in this competitive marketplace.

當然，我認為這是一個競爭激烈的市場，但正如我們在本季和上季的特許經營成長中所展示的那樣，我們當然認為EYLEA HD 和EYLEA 在這個競爭激烈的市場中都處於非常有利的位置。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Can you just elaborate on the drivers for the pricing pressure noted for EYLEA HD and whether these pressures are going to be ongoing on the Ford?

您能否詳細說明 EYLEA HD 定價壓力的驅動因素以及這些壓力是否會持續存在於福特汽車上？

And just in that context, maybe just kind of your outlook for overall growth of the branded anti-VEGF market in the context of the biosimilars.

正是在這種背景下，也許只是您對生物相似藥背景下品牌抗 VEGF 市場整體成長的展望。

So as we reflect on anti-VEGF category pricing pressure, that is something, Salveen, has an impact on all products in the category, branded products, biosimilar products as well, and it's not inconsistent with other competitive categories.

因此，當我們反思抗 VEGF 類別的定價壓力時，Salveen 對該類別中的所有產品、品牌產品、生物相似藥產品都有影響，並且與其他競爭類別並不矛盾。

What's really important to note though is what often prevails is the product that physicians most often want to prescribe, meaning what has been their experience, what is the safety profile of the product, what is the efficacy?

但真正要注意的是，通常流行的是醫生最常開處方的產品，這意味著他們的經驗是什麼，產品的安全性是什麼，功效是什麼？

And now in the case of bringing EYLEA HD to the marketplace, the durability.

現在，在將 EYLEA HD 推向市場的情況下，耐用性。

So we think those factors are very important and allow us to compete successfully in the anti-VEGF category.

因此，我們認為這些因素非常重要，使我們能夠在抗 VEGF 領域的競爭中取得成功。

As to overall category growth, I would say that it's probably roughly in -- and this is overall, not just branded, it's roughly in the mid-single-digit range.

至於整體類別的成長，我想說，它可能大致在 - 這是整體的成長，而不僅僅是品牌成長，它大致在中個位數範圍內。

And then come back again just to say a little bit more about the pricing pressure.

然後再回來談談定價壓力。

Obviously, that's something that's been more apparent for EYLEA and probably the product now having been on the marketplace for over a decade is understandable.

顯然，這一點對於 EYLEA 來說更為明顯，而且該產品現在已經上市十多年了，這可能是可以理解的。

The differentiation for EYLEA HD is the clinical profile, the product that is giving physicians the opportunity not only for the confidence in clinical aspects, results and safety as they have with EYLEA, but also now this really demonstrated durability that we're seeing more and more of.

EYLEA HD 的差異化在於臨床概況，該產品不僅為醫生提供了機會，讓他們對EYLEA 的臨床方面、結果和安全性充滿信心，而且現在也真正證明了我們看到的更多和更持久的耐用性。

And obviously, our clinical data is supporting in the longer term as well.

顯然，從長遠來看，我們的臨床數據也提供了支持。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

I just want to understand how high does EYLEA uptake so far is tracking versus your own internal expectations, given that, I mean, it seems like about 25% conversion has happened yet at point.

我只是想了解 EYLEA 到目前為止的吸收率與您自己的內部預期相比有多高，因為我的意思是，目前似乎已經發生了大約 25% 的轉換。

And at the same time, compared to -- this has been growing really rapidly.

同時，相較之下，這一數字成長得非常迅速。

So just trying to understand what are the dynamics that we need to look at here and if there are any levers you can pull going forward to help increase uptake?

那麼，我們只是想了解我們需要關注的動態是什麼，以及您是否可以採取任何槓桿來幫助提高採用率？

So let's answer the question.

那我們來回答一下這個問題吧。

Obviously, we don't give specific guidance on conversion or the size of the market, but we do talk about what we think the catalyst can be -- and I do feel that we have a bunch of catalysts next year, the potential approval and data for RVO, more importantly, perhaps the prefilled syringe by mid-year.

顯然，我們沒有就轉化或市場規模提供具體指導，但我們確實討論了我們認為催化劑可以是什麼——我確實覺得明年我們有很多催化劑，潛在的批准和RVO 的數據，更重要的是，也許是年中的預充式註射器的數據。

So I think that next year, we could see a little bit of an acceleration.

所以我認為明年我們可能會看到一些加速。

Obviously, we're working very hard.

顯然，我們正在非常努力地工作。

It's a great product.

這是一個很棒的產品。

But there are -- these things don't happen overnight because people do love EYLEA.

但這些事情不會在一夜之間發生，因為人們確實喜歡 EYLEA。

And it is more sticky than one might have anticipated but I think the progress is solid and we expect it to keep going.

它比人們預期的更有黏性，但我認為進展是堅實的，我們希望它能夠繼續下去。

Trung Huynh, UBS.

Trung Huynh，瑞銀。

This Kim for Trung from UBS.

這位來自瑞銀的 Kim for Trung。

So we want to switch gears to the obesity program aand about the ongoing Phase 2 (inaudible) and GP1 study.

因此，我們希望將重點轉向肥胖計劃以及正在進行的 2 期（聽不清楚）和 GP1 研究。

Seems like you recently increased the linvoseltamab from 620 plus to 1,000 with three new arms added.

看來您最近將 linvoseltamab 從 620 plus 增加到 1,000，並添加了三個新手臂。

And now the study has to investigational arm does seem like you want to very comprehensive to hear.

現在這項研究已經進入調查部門，看起來確實像你想要非常全面地聽到的那樣。

Could you provide more granularity why the protocol changes here are necessary?

您能否更詳細地說明為什麼需要更改此處的協議？

And why would you like to further expand the trial.

以及為什麼您想進一步擴大試驗範圍？

Can we have somebody to repeat that question because I really couldn't understand it at all -- Go ahead.

我們能否請某人重複一下這個問題，因為我真的完全聽不懂——請繼續。

Definitely.

確實。

Yes.

是的。

Just the ongoing first obesity study of [travelocituzumab] and itepekimab without P1.

這只是正在進行的第一個關於 [travelocituzumab] 和 itepekimab 的肥胖研究，沒有 P1。

So you recently increased the trial size to nearly 1,000.

因此，您最近將試驗規模增加到近 1,000 個。

Previously, I think it was 620-plus.

以前我以為是620以上。

You also added three new arms.

您還添加了三個新手臂。

So why do you think like those protocol changes are necessary?

那麼您為什麼認為這些協定變更是必要的呢？

And why would you like to further expand the trial?

為什麼要進一步擴大試驗範圍？

Yes.

是的。

I think what you're probably referring to is that we added additional dosing arms in our trial to expand different doses of the, hopefully, muscle-enhancing treatments.

我想你可能指的是我們在試驗中增加了額外的劑量組，以擴大不同劑量的肌肉增強治療。

And that's the major reason that the trial was enlarged.

這就是擴大審判範圍的主要原因。

So that we would have broader information on different doses and their effects on muscle preservation.

這樣我們就能獲得有關不同劑量及其對肌肉保存影響的更廣泛資訊。

Right.

正確的。

And just to remember, we didn't see any -- in the healthy volunteer study, we were able to do that because we didn't see any new safety signals.

請記住，我們沒有看到任何 - 在健康志願者研究中，我們之所以能夠做到這一點，是因為我們沒有看到任何新的安全信號。

So I think it's just a matter of exploring additional.

所以我認為這只是一個額外探索的問題。

Trying to find the right mix of antibodies with semaglutide to maximize the quality of the weight loss.

試圖找到抗體與索馬魯肽的正確組合，以最大限度地提高減肥品質。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

Sorry about the earlier mishap.

對先前的事故深表歉意。

Just a follow-up on it.

只是後續行動。

I know, George, you've spoken a lot about the really need for quality of weight loss, and I think that's very important.

我知道，喬治，你已經談了很多關於減肥品質的真正需要，我認為這非常重要。

Maybe talk to the regulatory environment for muscle or preservation or muscle building assets.

也許可以談談肌肉或保存或肌肉建設資產的監管環境。

I know FDA has been kind of hesitant there.

我知道 FDA 對此一直有些猶豫。

And they're really focused on weight loss, but maybe how you talk about how those will evolve in the coming years.

他們確實專注於減肥，但也許你如何談論這些在未來幾年將如何發展。

Yes.

是的。

I guess what you're referring to is obviously we all know, and it's been widely noted and acknowledged that in the setting of the very rapid weight loss that can be caused by these GLP related agents, you get significant lean body and muscle loss up to 30%, 40% of the weight loss, especially because most of these patients actually go off these treatments and then often cycle, this can actually lead to cumulative loss of muscle over time, which can actually be quite catastrophic.

我想你所指的顯然是我們都知道的，並且已經被廣泛注意到和承認，在這些 GLP 相關藥物可能導致體重快速減輕的情況下，你會得到顯著的瘦身和肌肉損失30%、40 % 的體重減輕，特別是因為大多數患者實際上停止了這些治療，然後經常騎自行車，這實際上會導致隨著時間的推移肌肉逐漸減少，這實際上可能是相當災難性的。

We may be creating a secondary problem here over time as people cycle on and off these treatments.

隨著時間的推移，隨著人們循環使用和停止這些治療，我們可能會在這裡產生一個次要問題。

So our approaches are intended to maintain the muscle.

所以我們的方法就是要維持肌肉。

That said, the agents because they're promoting muscle.

也就是說，這些藥物是因為它們可以促進肌肉。

Remember, muscle is the major nonessential spender of energy that is renowned for its ability to expand energy.

請記住，肌肉是主要的非必需能量消耗者，以其擴展能量的能力而聞名。

We've seen in the animal models that it can also cause our approaches when you maintain muscle, you're increasing the metabolic rate.

我們在動物模型中看到，當你保持肌肉時，它也會導致我們的方法，你會增加新陳代謝率。

So you're actually expending more calories, so you actually can lose more weight while you're gaining the muscle or preserving the muscle because the muscle itself is eating up the calories or using up the calories.

所以你實際上消耗了更多的卡路里，所以你實際上可以在增加肌肉或保留肌肉的同時減輕更多的體重，因為肌肉本身正在消耗卡路里或消耗卡路里。

So the easiest regulatory path will be if our approach is, as has been seen in the preclinical studies actually result in more weight loss but a better composition of that weight loss.

因此，最簡單的監管途徑將是，正如臨床前研究中所見，我們的方法實際上會導致更多的體重減輕，但體重減輕的成分會更好。

So that one won't even have to actually rely on a muscle regulatory end point, just on the increased weight loss itself.

因此，人們甚至不必真正依賴肌肉調節終點，只需依賴體重減輕本身的增加即可。

Of course, one will then hopefully be able to describe, and this is all part of ongoing discussions with regulatory agencies that not only might you be seeing increased weight loss, but the body composition results will be better.

當然，人們希望能夠進行描述，這都是與監管機構正在進行的討論的一部分，您不僅可能會看到體重減輕，而且身體組成結果也會更好。

So the simplest regulatory path will be just by increasing the actual weight loss, and then you'll be able to show secondary end points that you're doing better on composition of the weight loss as well.

因此，最簡單的監管途徑就是增加實際體重減輕，然後您將能夠向次要終點表明您在體重減輕的組成方面也做得更好。

That said, we are going to be measuring metabolic parameters.

也就是說，我們將測量代謝參數。

And we're also going to be measuring functional assets as well.

我們也將衡量功能性資產。

And those are, of course, regulatory paths as well that will be more complicated and probably require a larger and longer studies than just the weight loss studies themselves.

當然，這些監管途徑也將更加複雜，並且可能需要比減肥研究本身更大規模、更長期的研究。

So of course, we expect to be improving metabolic endpoints.

因此，我們當然希望改善代謝終點。

We expect to be improving functional endpoints whether we're going to be needing those as exploratory or descriptive endpoints or whether we're going to end up relying on them for approval remains an open story.

我們希望改進功能端點，無論我們是否需要這些端點作為探索性或描述性端點，或者我們是否最終依賴它們來獲得批准仍然是一個懸而未決的故事。

But the goal, of course, is to show these benefits in the setting of maintenance of the muscle while maintaining or actually getting greater weight loss.

但當然，我們的目標是在維持或實際上獲得更大的減肥效果的同時，在維持肌肉的情況下展示這些好處。

I should also point out that in our pipeline, we have a variety of what we call unimolecular solutions, a whole series of molecules that have the ability all within the same molecule to do all of these things.

我還應該指出，在我們的管道中，我們有各種所謂的單分子解決方案，即一系列分子，它們都具有在同一個分子內完成所有這些事情的能力。

And obviously, those will all have their own indifferent regulatory path, some of which might be much more expedient in terms of what endpoints you can use for approval and so forth.

顯然，這些都會有自己的冷漠監管路徑，其中一些在您可以使用哪些端點進行批准等方面可能更為方便。

David Risinger, Leerink Partners.

大衛‧瑞辛格 (David Risinger)，Leerink 合夥人。

So I have -- I'll just keep it to one question, please. regarding next-gen product development.

所以我——請只回答一個問題。關於下一代產品開發。

So clearly, Regeneron was extremely successful in creating EYLEA HD.

顯然，Regeneron 在創建 EYLEA HD 方面非常成功。

Could you talk about your efforts to develop a next-gen Dupixent, including whether it would be a less frequently administered product?

您能否談談您在開發下一代 Dupixent 方面所做的努力，包括它是否會成為一種管理頻率較低的產品？

All we can say is that we are constantly working on both improving approaches for something where we already have important products such as in the DUPIXENT class as well as coming up with entirely new and different products and approaches as well.

我們只能說，我們正在不斷致力於改進我們已經擁有重要產品（例如 DUPIXENT 類）的方法，並提出全新的、不同的產品和方法。

And as you might imagine, we delivered with HD, I mean, this is what we're trying to do all the time.

正如您可能想像的那樣，我們提供了高清，我的意思是，這就是我們一直在努力做的事情。

We're trying to improve the current approaches but we're also trying to come up with an entirely different next-gen approach as well.

我們正在努力改進目前的方法，但我們也在嘗試提出一種完全不同的下一代方法。

That's what we do here at Regeneron.

這就是我們在再生元所做的事情。

Thanks, George.

謝謝，喬治。

There's time for two more questions, Shannon.

還有時間問兩個問題，香農。

William Pickering, Bernstein.

威廉‧皮克林，伯恩斯坦。

Do you think that the rate of biosimilar erosion for Lucentis is a good proxy for what we can expect for EYLEA.

您認為 Lucentis 的生物相似藥侵蝕率可以很好地代表我們對 EYLEA 的預期嗎？

I think they saw about 25% of volume switch over in the first 12 months.

我認為他們在前 12 個月內看到了大約 25% 的交易量發生了變化。

And are there any important differences in the commercial dynamics to keep in mind?

商業動態方面是否有任何需要記住的重要差異？

Just would say that it's very -- and way too early to comment.

只是想說現在發表評論還為時過早。

And I think that through the conversation today, we've gone through the factors that create such confidence in EYLEA, the demonstrated use of the product on a worldwide basis, but very early to try to make any comment about a product that hasn't been used in the real-world setting yet.

我認為，透過今天的談話，我們已經了解了對 EYLEA 產生如此信心的因素，以及該產品在全球範圍內的使用情況，但很早就嘗試對尚未獲得認可的產品做出任何評論。在環境中使用。

Well, I think it's also important.

嗯，我認為這也很重要。

The situation is very different because at the same time, there are patients on EYLEA who might have a choice of going to a bio similar staying and EYLEA are actually moving to a differentiated product profile, which is EYLEA HD.

情況非常不同，因為與此同時，EYLEA 上的患者可能可以選擇生物類似的住宿，而 EYLEA 實際上正在轉向差異化的產品配置，即 EYLEA HD。

So that's a very different sort of situation than you had with just the Lucentis erosion situation.

因此，這是一種與 Lucentis 侵蝕情況截然不同的情況。

Shannon, let's take our last question.

香農，讓我們來回答最後一個問題。

Cory Kasimov, Evercore ISI.

科里·卡西莫夫，Evercore ISI。

I wanted to follow up on Carter's question earlier about capital allocation priorities.

我想跟進卡特早些時候關於資本配置優先事項的問題。

I'm sure you're pretty frustrated by the market reaction to recent developments around EYLEA.

我確信您對 EYLEA 近期發展的市場反應感到非常沮喪。

I know you have nearly $3 billion left in your authorized share repo.

我知道您的授權股票回購中還剩下近 30 億美元。

But have you given any thoughts to an ASR?

但您有考慮過 ASR 嗎？

And what are your evolving views around a dividend given that you already have over $15 billion in net cash on hand?

鑑於您手頭上已經擁有超過 150 億美元的淨現金，您對股息的看法有何變化？

And obviously have another significant inflection in additional cash generation not too far down the road.

顯然，在不久的將來，額外的現金產生也會出現另一個重大變化。

So we have lots of discussions on this.

所以我們對此進行了很多討論。

We don't really have anything more to add than we've said publicly, which is perhaps the best opportune time to think about the dividend is when we have paid off the development balance to Sanofi, which we anticipate should be somewhere around the end of 2026.

除了我們公開表示的以外，我們實際上沒有什麼要補充的，這也許是考慮股息的最佳時機，就是我們向賽諾菲支付了開發餘額的時候，我們預計應該在年底左右完成2026 年。

But beyond that, how we repurchase stock, when weather, et cetera, et cetera, is something that we really don't discuss until it's happening.

但除此之外，我們如何回購股票，當天氣等因素發生時，我們實際上不會在事情發生之前討論。

Okay.

好的。

Thank you, Glen, and thanks to everyone who dialed in for your interest in Regeneron.

謝謝你，格倫，也感謝所有對再生元有興趣的人。

We apologize to those remaining in the Q&A queue that we did not have a chance to hear from.

我們向那些留在問答隊列中但我們沒有機會收到訊息的人表示歉意。

As always, the Investor Relations team here.

一如既往，投資者關係團隊在這裡。

Regeneron is available to answer any remaining questions you may have.

再生元可以回答您可能有的任何剩餘問題。

Thank you once again.

再次感謝您。

Happy Halloween.

萬聖節快樂。

Happy Diwali.

排燈節快樂。

Have a great day.

祝你有美好的一天。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。