再生元 (REGN) 2026年第三季度业绩电话会议：营收增长36%

核心要点

• 再生元制药（NASDAQ: REGN）公布2026年第三季度营收为51亿美元，同比增长36%；Non-GAAP摊薄后每股收益（EPS）增长70%至20.07美元。
• 据赛诺菲报告，达必妥（Dupixent）全球净销售额创下65亿美元的历史新高，按固定汇率计算同比增长35%。美国市场销售额增长40%至51亿美元。
• 美国市场EYLEA HD销售额增长62%至6.99亿美元；但由于一代EYLEA销售额下降41%，EYLEA HD与EYLEA在美国的合计销售额微降1%至11亿美元。
• Libtayo全球销售额按固定汇率计算增长51%至5.50亿美元，其中美国市场销售额增长81%至3.96亿美元。
• 再生元预计将在2026年第四季度将赛诺菲的10亿美元首付款确认为合作收入。
• 管理层预计，随着公司推进骨髓瘤、抗凝、肥胖症、体位性心动过速综合征（POTS）和代谢功能障碍相关脂肪性肝炎（MASH）的注册临床项目，2027年研发费用将增长十几百分点中段（15%左右）。

核心财务业绩

业务与运营表现

Dupixent

Dupixent仍是再生元最大的增长驱动力。第三季度全球销售额突破65亿美元，全球接受治疗的患者已超过150万人。管理层将美国市场的增长归因于所有适应症的需求，以及赛诺菲报告的有利的总额至净额（gross-to-net）调整。

该药物已获批用于九种2型炎症性疾病。再生元和赛诺菲还在推进四种下一代长效单抗和双特异性抗体，旨在保持类似Dupixent疗效和安全性的同时减少给药频率。其中主导的IL-13抗体目标为每三至六个月给药一次。

EYLEA产品线

美国市场EYLEA HD与EYLEA合计销售额为11亿美元，下降1%。在医生端单位需求环比增长20%的支撑下，EYLEA HD占该系列销售额的近三分之二。

一代EYLEA销售额下降41%至4.00亿美元，医生端需求环比下降高单数字百分比。管理层指出，新增的阿柏西普（aflibercept）2毫克生物类似药上市和价格压力是主要挑战。

公司对其EYLEA HD预充式注射器将在2026年底前获得FDA批准保持乐观。

Libtayo

Libtayo创造了5.50亿美元的全球销售额新高，年化运行率达到约22亿美元。增长主要受非黑色素瘤皮肤癌和非小细胞肺癌驱动，包括在皮肤鳞状细胞癌辅助治疗中的应用。

预计FDA将于2027年3月前就更新的6周给药方案（输注时间可短至15分钟）做出裁决。

研发管线进展

预计FDA将于2026年11月就cemdisiran用于全身型重症肌无力作出裁决。如果获得批准，管理层表示这将成为该疾病的首款siRNA疗法，也是唯一提供每季度皮下给药一次的疗法。

在MASH方面，Side B siRNA的首次人体研究纳入了40名受试者。管理层报告称，单次给药使肝脏脂肪平均减少约70%，疗效可持续至24周，并伴有肝酶改善。再生元计划快速推进该项目进入注册性临床研究。

据公司称，Ubamatamab单药疗法在晚期低级别浆液性卵巢癌中实现了约70%的客观缓解率。目前正在招募潜在的注册队列，并计划于2027年中期开展确认性III期试验。

再生元还预计将在2026年底前获得cemdisiran联合pozelimab治疗阵发性睡眠性血红蛋白尿症（PNH）的关键结果。地图状萎缩的中期数据预计将于2027年初公布。

管理层业绩指引

• 管理层预计2026年第四季度EYLEA HD医生端单位需求将环比增长约10%，部分被价格压力抵消。预计全年EYLEA HD销售额相比2025年增长将超过50%。
• 一代EYLEA需求预计在第四季度将环比下降十几百分点低段至中段（约10%—15%）。
• 再生元预计将在2026年第四季度将赛诺菲全部10亿美元首付款确认为合作收入。
• 2026全年股票回购总额预计约为30亿美元。
• 管理层目前预计2027年研发费用将较2026年增长十几百分点中段（15%左右）。
• 与2026年相比，2027年有效税率预计将面临约100至200个基点的上行压力。
• 再生元预计2026年第四季度不会产生Inmazeb收入。根据新BARDA（生物医学高级研究与发展局）拨款提供的供应预计将于2027年底开始，并持续至2031年。

风险与关注事项

• EYLEA产品线面临着来自更多阿柏西普生物类似药日益加剧的竞争、持续的价格压力以及一代EYLEA需求下滑的风险。
• 若干管线突破仍取决于监管裁决，包括cemdisiran和EYLEA HD预充式注射器。
• 再生元不断扩大的后期管线将需要更高的研发支出，管理层预测2027年费用增长为十几百分点中段。
• MASH、POTS和卵巢癌方面的早期临床结果需要在更大规模的注册性或III期研究中加以确认。
• 管理层承认在广泛治疗领域的项目研发和商业化存在执行风险。

分析师问答亮点

MASH差异化：管理层表示，Side B项目直接针对与肝脏脂肪及更广泛肝病相关的且经基因验证的通路。公司将该方法与间接减少肝脏脂肪的疗法进行了对比，同时强调注册细节将另行讨论。

业务拓展：再生元表示，从研究平台到商业化产品，对处于任何研发阶段的外部资产均持开放态度。管理层强调的是科学契合度与估值，而非针对特定的管线阶段。

下一代抗炎产品组合：这四款长效候选药物可能会针对不同适应症量身定制，而非作为可互换的资产。管理层突出了每年给药2至4次的潜在便利性，但未透露更广泛的产品线策略。

肥胖症策略：再生元计划启动olatorepatide的全球III期研发，并认为将其与Praluent（波立达）联合使用具有差异化优势，可同时针对肥胖症或2型糖尿病以及高胆固醇血症和心血管风险。

PNH商业潜力：管理层将cemdisiran与pozelimab联合用药的早期数据描述为令人鼓舞，但表示在评估换药潜力前仍需要更多临床差异化证据。

业绩电话会议完整文字记录

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完整财报电话会议逐字稿

管理层陈述

Operator

Welcome to the Regeneron Pharmaceuticals Third Quarter 2026 Earnings Conference Call. My name is Shannon, and I'll 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.

Ryan Crowe

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 2026 Earnings Conference Call. An archived and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes.

Joining me on today's call are Dr. Leonard Schleifer, Co-Founder, Board Co-Chair, President and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, Board Co-Chair, President and Chief Scientific Officer; Marion McCourt, Executive Vice President, Commercial; and Chris Fenimore, Executive Vice President Finance and Chief Financial Officer. For our call today, Len will briefly review key third quarter performance drivers and highlight a few emerging pipeline programs. George will then detail our recent pipeline progress, followed by Marion, who will review our commercial performance and finally, Chris will discuss our financial results and outlook.

After our prepared remarks, the remaining time will be available for Q&A. 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 forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement changes to drug pricing regulations and requirements and our drug pricing strategy, intellectual property, pending litigation and other proceedings and competition. 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 in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2026 and 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. 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.

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

Leonard Schleifer

Thank you, Ryan, and welcome to everyone joining our call today. We're pleased to report another quarter of strong performance, driven by outstanding commercial execution and a large and diverse pipeline that is continuing to deliver on its promise. Total revenue grew 36% and non-GAAP earnings per share grew 70% compared to the third quarter of 2025. This marks our third consecutive quarter of double-digit growth on both the top and bottom lines. Our commercial teams continue to execute at a very high level. Dupixent, EYELEA HD and Libtayo each set new all-time highs for quarterly net sales for the second quarter in a row. Dupixent Global net sales in the third quarter as reported by Sanofi, reached a record $6.5 billion, up 35% year-over-year at constant currency which is truly remarkable for a medicine approaching 10 years on the market.

In the U.S., where Dupixent is the leading biologic in 8 of its 9 approved FDA-approved indications quarterly net sales grew 40% and exceeded $5 billion for the first time, primarily driven by robust demand across all indications as well as gross to net favorability as disclosed by Sanofi. EYLEA HD quarterly net sales in the U.S. reached a new all-time high of approximately $700 million, up 62% from a year ago and now represent nearly 2/3 of our U.S. retinal franchise. Physician unit demand grew 20% sequentially, reflecting the value retinal specialists and their patients in extended dosing intervals as well as last year's label enhancements, which added the retinal vein occlusion indication and greater dosing flexibility. We remain optimistic for approval of the prefilled syringe before the end of the year, and we expect it to drive even further adoption, if approved. Libtayo is making important differences for patients with skin and lung cancers, and it continues to build clinical and commercial momentum. In the U.S., it is the leading immunotherapy in non-melanoma skin cancers and the second most prescribed immunotherapy in non-small cell lung cancer, global net sales reached a record $550 million, up 51% in constant currency and U.S. net sales grew 81% to nearly $400 million.

Last week at ESMO, we presented longer-term data from our Phase III C-POST trial showing an increase in overall survival benefit with adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma, where it is the first and only approved immunotherapy. Libtayo is now on an annual run rate of approximately $2.2 billion and remains the foundation for our broader oncology strategy. Beyond our strong commercial execution, our pipeline is poised to deliver several potential blockbuster opportunities over the next several years. Let me highlight new advances in 4 of our pipeline programs, while George will discuss in more detail, along with other late-stage clinical programs including Factor XI Lynozyfic and olatorepatide. In neuromuscular disease, we expect an FDA decision in November for cemdisiran in generalized myasthenia gravis. If approved, cemdisiran would be the first siRNA therapy for general myasthenia gravis and the only treatment that can offer quarterly subcutaneous dosing.

Early in my career as a neurologist, I cared for many patients with this difficult-to-treat condition so it is particularly gratifying to see us bring forward and potential new treatment option for them. In metabolic disease, MASH affects millions of people and treatment options are limited. Our Side B program is a great example of our genetics driven scientific process. Regeneron Genetics Center discovered that people with naturally occurring loss of function variants of the Side B gene have markedly lower risk of fatty liver disease and cirrhosis, which led us to develop a first-in-class siRNA that targets Side B. We are encouraged by the initial clinical data would suggest best-in-class, best-in-disease potential, and we are rapidly advancing this program into registration-enabling studies. I'd also like to highlight our program for postural orthostatic tachycardia syndrome or POTS. This is an increasingly recognized debilitating condition that affects many young people often disrupting school, work and daily life with very few effective treatment options and no FDA-approved medicines.

Recent estimates suggest that between 500,000 and several million people in the U.S. alone suffer from POTS. We believe the initial clinical data that George will highlight supports our antibody's potential to become the first FDA approved treatment for this disease, and we plan to initiate a potentially pivotal study next year pending regulatory feedback. In oncology, we recently shared encouraging data for the ubamatamab, our MUC16xCD3 bispecific antibody and advanced low-grade serous ovarian carcinoma. This is a rare and difficult-to-treat form of ovarian cancer that often affects younger women who urgently need better treatment options. We saw durable responses in heavily pretreated patients at rates well above those historically seen with available therapies. We are already enrolling a dedicated potentially registrational cohort and plan to start a confirmatory Phase III study next year. Each of these programs is supported by compelling clinical data, human genetic validation or both. It is no accident that they expand 4 distinct therapeutic areas and that each has first-in-class or best-in-disease potential. That reflects our disease-agnostic enterprise approach to R&D.

Rather than confining ourselves to a few therapeutic areas we apply our core technologies wherever the science leads us. These technology platforms, including our Velocimmune antibody and bispecific engines, Regeneron Genetic Center and siRNA and gene editing technologies that allow us to translate genetic discoveries like Side B into potential medicines. Today, that approach supports approximately 50 clinical programs, spanning immunology, oncology, ophthalmology, hematology, cardiovascular and metabolic diseases, neurology and rare diseases. Our commercial organization has been built the same way. Our teams already call on ophthalmologists, dermatologists, pulmonologists, allergists, gastroenterologists, ENT specialists, oncologists, cardiologists and hematologists. And if cemdisiran is approved, we will begin to call on neurologists as well. That means many of our pipeline medicines, including several of the programs I just mentioned, can launch into specialties where we already have deep relationships and expertise and can leverage our existing infrastructure and capabilities.

Briefly on business development. Historically, we have been a net out licensor of innovation with the most recent example being the expansion of our alliance with Sanofi. We are contributing to the alliance for next-generation long-acting antibodies or invented at Regeneron that target the same pathways that made Dupixent so successful. Regeneron will lead research and development, and Sanofi will lead global commercialization now with greater transparency and increased participation by Regeneron. If approved, these medicines can also benefit from Dupixent's commercial leadership and the strong market access position it has established an advantage neither company could capture on its own. At the same time, our financial strength positions us to bring differentiated external innovation into Regeneron. We've done this effectively to date, primarily through early-stage research collaborations, including those that built our emerging genetic medicines pipeline across siRNA therapeutic gene therapy and gene editing. We continue to evaluate a wide range of opportunities from early clinical programs and platforms to commercial-stage products with a sharp focus on valuation and strategic fit.

In closing, this was an exceptional quarter by every measure. Our 3 core growth brands are performing at record levels and our expanded alliance with Sanofi positions us to lead the next era of type 2 inflammation medicines. Our pipeline is poised to deliver additional potential blockbusters across a broad range of diseases and our commercial organization is built to bring them to patients. Our future is bright, and we remain focused on translating our science into new medicines that can make a meaningful difference for patients and create long-term value for shareholders. With that, let me turn the call over to George.

George Yancopoulos

Thanks, Len. For my remarks today, I'll first provide further details on the 4 programs that Len highlighted then cover other key updates from our pipeline. Beginning with our C5 program. Regulatory submissions are under review for cemdisiran or C5 siRNA for generalized myasthenia gravis or gMG. An FDA decision is expected next month, and the European Commission decision is anticipated in the second half of 2027. If approved, cemdisiran will be the first and only siRNA therapy approved for gMG. It will be distinguished by a combination of rapid onset, consistent efficacy throughout the dosing interval, manageable safety and convenient subcutaneous dosing just 4 times per year.

Our C5 program also includes a co-formulation of cemdisiran with pozelimab, our C5 antibody that's already FDA approved for protein using enteropathy. Together, they are being evaluated as a combination therapy for paroxysmal nocturnal hemoglobinuria, or PNH, where we expect to report pivotal results by the end of the year. Initial results from a lead-in cohort of the Phase III trial suggest that our novel combination approach could provide best-in-class control of intravascular hemolysis. Our C5 program further includes evaluating cemdisiran with and without pozelimab in geographic atrophy, or GA, via systemic administration. We now expect to report interim 26-week data from an exploratory cohort of our ongoing Phase II/III study in early 2027 where we hope to see a trend towards slowing of lesion growth comparable to the approved agents at a similar time point. A potential advantage of our systemic approach is the ability to treat bilateral disease, which affects many patients while avoiding the potentially devastating ocular safety events seen with certain FDA-approved agents that are delivered intravitreally.

In addition, we are exploring our own intravitreal administration of pozelimab which might also offer safety advantage over currently approved therapies. Moving to MASH. At the upcoming Liver Meeting in November, we will present first-in-human data for our siRNA for Side B. This target was discovered by our Regeneron Genetics Center, which identified Side B's unprecedented ability to protect against liver fat and liver disease through our large-scale human genetics database. In the initial data from 40 participants, a single dose was well tolerated and reduced liver fat by approximately 70% on average from baseline in just 2 weeks -- 12 weeks, bringing mean liver fat to near or below upper limit of normal at every dose level tested. This effect was durable through 24 weeks of follow-up and was accompanied by improvements in liver enzymes, consistent with reduced liver cell injury. These results not only clinically validate beside the discovery from the Regeneron Genetic Center, but suggests that we have a breakthrough new approach that directly addresses a genetic driver of MASH and could benefit the millions of MASH patients underserved by current approaches. We are working to rapidly advance to registrational trials and look forward to sharing more about this agent that our next Regeneron roundtable investor event scheduled for November 10.

Moving to postural orthostatic tachycardia syndrome or POTS. This disease appears to be driven by chronic pathological depletion of intravascular volume. Current treatments include salt and fluid administration, which provide only short-term relief. There are no FDA-approved therapies and all label treatments are generally unsatisfactory. At the American Autonomic Society Congress in November, we will be reporting results -- initial results from our Phase II study. After a single treatment with high-dose [indiscernible] , we saw improvements in the 2 key endpoints for this disease, tachycardia and orthostatic symptoms, sustained over 4 weeks from a single dose. These improvements appear to be associated with durable restoration of intravascular volume. We are planning to initiate a potentially registrational study in the first half of next year pending regulatory feedback, and we believe this could be a game-changing treatment for a debilitating disease with significant unmet need.

Next, turning to ubamatamab, our MUC16xC3 bispecific antibody in development for ovarian cancer, which was featured in a late-breaking plenary session at the International Gynecological Cancer Society Meeting. The data presented there, along with additional data indicate that ubamatamab monotherapy has an approximately 70% objective response rate with prolonged progression-free survival in women with advanced low-grade serous ovarian cancer with an acceptable safety profile and no biomarker selection required. To put this in context, chemotherapy and endocrine therapy have historically delivered response rates below 15% in this setting and the only approved therapy achieved a 44% response rate, but only in the roughly 30% of patients with low-grade serous ovarian cancer with tumor carry a specific biomarker.

Based on these encouraging early results for ubamatamab, we're enrolling a potentially registrational cohort and plan to start a confirmatory Phase III trial in mid-2027. Turning now to our larger late-stage programs and starting with Lynozyfic or BCMAxCD3 bispecific. We believe Lynozyfic is differentiated not only by the efficacy demonstrated in late-line multiple myeloma, but also by our development strategy, which creates important new opportunities in first and second-line settings and even in premalignant disease, with pivotal readouts beginning next year. In 2027, we expect initial results from our confirmatory trial of lynozyfic monotherapy versus standard of care in patients with multiple myeloma who received at least one prior line of therapy. In 2028, we expect initial results from our first-line study in transplant ineligible patients as well as from our lynozyfic, carfilzamib combination study in patients who received at least one prior line of therapy.

We're also enrolling potentially registrational cohort in second-line light chain amyloidosis and plan to start a Phase III study in first-line light chain amyloidosis by early 2027. In addition, we are actively enrolling a Phase III trial in high-risk smoldering myeloma. We also have a differentiated development strategy for odronextamab, our CD20xCD3 bispecific. We have a regulatory application under FDA review for relapsed/refractory diffuse large B-cell lymphoma with the February 2027 target action date. Importantly, we expect results in 2028 from our fully enrolled Phase III study of odronextamab monotherapy in first-line follicular lymphoma, which could provide these patients who have high unmet need with the first bispecific and chemo-free immunotherapy option.

Moving to anticoagulation. For Factor XI inhibition, we continue to favor our antibody approach over small molecules because antibodies may enable more potent and specific inhibition, with the potential to improve anti-thrombotic activity without increasing bleeding risk or introducing off-target safety issues. Our program features cenvacibart, our catalytic domain antibody and amrecibart, our AT domain antibody. I'm pleased to report that all but one of the planned Phase III studies are now enrolling patients. These studies span venous thromboembolism prevention after total knee replacement, stroke prevention in patients with atrial fibrillation, cancer associated with thrombosis, peripheral artery disease and most recently, venous thromboembolism prevention in patients with peripherally inserted central catheters. The one remaining Phase III study yet to initiate in secondary stroke prevention is expected to begin enrollment by year-end.

We expect pivotal results from our new replacement program starting next year with other pivotal studies expected to read out in 2028 and beyond. Turning to olatorepatide, our dual GLP-1/GIP receptor agonist in license from Hansoh. Recently, Hansoh presented encouraging efficacy, safety and tolerability data from their Phase III trial in patients with obesity in China at the European Association for the Study of Diabetes Conference, we look forward to starting our global Phase III program, which is differentiated by our ability to co-formulate olatorepatide with praluent, our PCSK9 antibody we believe this could provide an important new treatment option for the many patients with obesity and type 2 diabetes who comorbidities also suffer from hypercholesterolemia and increased cardiovascular risk and we plan to begin registrational studies of this combination next year.

As Len discussed, we recently announced an expansion of our alliance with Sanofi. Building on the success of Dupixent in the validation of the IL-4 and IL-13 pathways as safety drivers of type 2 inflammation, the alliance is advancing Regeneron's 4 fully human Velocimmune-derived long-acting antibodies and bispecifics. These candidates are designed to preserve Dupixent like efficacy and safety while enabling substantially less frequent dosing. All 4 candidates avoid the heavy engineering that tends to compromise biopharmaceutical properties or raise the risk of antidrug antibodies. Our candidates, which are fully human and non-engineered, also share important molecular properties. So learnings from one should carry over to the others and potentially support an expedited development. Our first in-human trial for our lead IL-13 antibody, which has a target dosing interval of every 3 to 6 months, is currently enrolling with patients with atopic dermatitis with registrational trials expected to begin in late 2027 and 2028.

Three additional programs a long-acting IL-13 bispecific, a long-acting IL-413 bispecific, a long-acting antibody to IL-4 receptor alpha and an IL-4 ligand antibody are expected to enter the clinic next year. Relevant to these programs, I want to end by reminding you that we have previously shared early clinical results for our BCMAxCD3 bispecific in combination with Dupixent in severe food allergy. These results strongly supported our hypothesis that fluid alleges could potentially be cured by rapidly and completely depleting plasma cells, which produce immunoglobin including the allergy-causing IgEs and then continuously suppressing the return of IgE antibodies by blocking IL-4 and IL-13. While the BCMA by CD3 eliminates plasma cells producing all classes of immunoglobin, we have invented a new bispecific antibody that selectively eliminates only the IgE-producing and allergy-causing plasma cells.

We plan to build on our groundbreak results combining our BCMA bispecific with Dupixent by expeditiously pursuing this more targeted approach. With clinical studies of this new bispecific antibodies to start in the first half of 2027. In summary, we have strong momentum across our broad and diverse pipeline that we believe that has the potential to change the practice of medicine across many diseases with high unmet need. With that, let me turn it over to Marion.

Marion McCourt

Thank you, George. Our third quarter results reflect strong commercial execution across our portfolio with our largest brands achieving new all-time highs in net sales. Our team is also focused on recent and upcoming launches with pasatru, now approved in the U.S. for ultra-rare FOP and we are preparing for the November PDUFA for cemdisiran in generalized myasthenia gravis. Starting with Dupixent, which continues to deliver transformative benefits to patients across 9 type 2 inflammatory diseases with more than 1.5 million patients currently treated worldwide.

In the U.S., Dupixent remains the most prescribed branded biologic among dermatologists, pulmonologists, allergists and ENTs. Third quarter worldwide net sales exceeded $6.5 billion, reflecting 35% growth on a constant currency basis. U.S. net sales grew 40% year-over-year to $5.1 billion driven by continued growth across all indications and age groups, as well as favorable gross to net adjustments as reported by Sanofi. Dupixent is the leading biologic across our blockbuster indications of atopic dermatitis as a nasal polyps and the synepholic esophagitis reported by its best-in-class clinical efficacy and safety profile. Uptake is also strong in our more recently launched indications of COPD, Pragaagelaris, chronic spontaneous urticaria, bolospempheloid and allergic fungal rhinositis with continued growth in new-to-brand prescriptions.

With significant opportunity for future growth across all 9 indications, Dupixent is well positioned over both the near and long term. Additionally, we are excited about the recently announced expansion of the Regeneron Sanofi Alliance, and to continue building on the strong foundation we've laid together with Dupixent. Turning to our retinal franchise. In the third quarter, combined EYLEA HG and EYLEA U.S. net sales were $1.1 billion, down 1% compared to last year with EYLEA HD now comprising nearly 2/3 of the franchise net sales. Third quarter EYLEA HD net sales in the U.S. were $699 million, up 62% versus prior year. These results demonstrate strong physician unit demand, which grew 20% from the second quarter.

This growth is driven by the ongoing benefit of recent label enhancements and which have increased adoption and broadened use of EYLEA HD across the spectrum of retinal practices, physicians increasingly recognize EYLEA HD as the best-in-class product in the anti-VEGF category based on its efficacy, safety and durability. EYLEA U.S. net sales were $400 million for the quarter, a 41% decrease versus the prior year. Sequential physician unit demand declined by a high single-digit percentage compared to the second quarter, with this decline partially offset by favorable gross to net adjustments. Both EYLEA HD and EYLEA benefited modestly from the timing of end of quarter shipments. Looking ahead to the fourth quarter, we expect continued EYLEA HD momentum with sequential physician unit demand growth of approximately 10% and partially offset by ongoing pricing pressure, resulting in full year net sales growth of over 50% compared with 2025. For EYLEA, we expect a sequential demand decline in the low to mid-teens in the fourth quarter.

Overall, the franchise remains in a strong position despite increasing competition from additional Aflibercept 2-milligram biosimilar launches and we look forward to potential FDA approval of the EYLEA HD prefilled syringe to help sustain EYELEA HD momentum in 2027 and beyond. Turning to Libtayo, which delivered worldwide net sales of $550 million, up 51% year-over-year on a constant currency basis, and the U.S. net sales were $396 million, up 81%. In non-melanoma skin cancer Lota continues its strong trajectory as the leading immunotherapy. In the U.S., the recent approval in adjuvant CSC is helping to drive growth and is changing the treatment paradigm. Libtayo remains the only NCCN Category 1 preferred immunotherapy option for eligible patients and ongoing formulary wins are driving increased usage. In non-small cell lung cancer, Libtayo remains the second most prescribed immunotherapy as physicians increasingly recognize its strong clinical profile. We continue to build on Libtayo's strong momentum by enhancing the patient experience through extended dosing and shorter infusion times across all approved indications.

We recently received a positive CHMP opinion for every 6-week dosing for Libtayo, along with an infusion time as short as 15 minutes. And SBLA for this updated dosing regimen is under review with the FDA with a decision expected by March 2027. We expect continued growth for Libtayo as we gained incremental share in lung cancer and drive uptake in adjuvant CSCC. Onto lenzific in multiple myeloma, physician feedback on the currently approved late line setting remains positive based on Linac's differentiated efficacy and safety profiles, lower hospitalization requirements and convenient dosing despite its strong profile, we expect Lenses growth to remain modest as we work to advance into earlier lines of therapy. We are also building Regeneron's ever disease portfolio, serving patients with significant unmet need.

Evkeeza continues to grow in its sixth year on the market with U.S. net sales of $55 million, up 28% versus the prior year. We have also expanded our portfolio with the recent launches of Otarmeni for genetic hearing loss and pasatru for FOP. Initial progress for both brands is promising, and we look forward to helping patients suffering from these devastating diseases Finally, in neurology, we are preparing for the potential launch of cemdisiran and generalized myasthenia gravis, which has in November PDUFA date. We see significant commercial opportunity for cemdisiran based on 3 key factors: its novel siRNA modality, rapid onset and durable efficacy without the waning treatment effect observed with many other approved therapies, and convenient 4x per year subcutaneous dosing.

In closing, our third quarter results reflect strong commercial capability across therapeutic areas. We've built an effective commercial infrastructure that enables us to execute across both in-line brands and new launches. As Len mentioned earlier, our commercialization platform currently spans nearly every relevant specialty, and this market experience positions us well for the many potential new products from our pipeline, whether a common or rare disease medicine, specialty or internal medicine prescriber, medical or pharmacy benefit product, we are confident in the capabilities of our commercial organization in both the near and longer term. And with that, I'll turn it over to Chris.

Christopher Fenimore

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis unless otherwise noted. Regeneron delivered a strong third quarter, once again reaching double-digit growth on both the top and bottom line driven by some sustained momentum across our key growth drivers and solid execution throughout the business. Third quarter total revenue increased 36% from the prior year to $5.1 billion, driven primarily by higher Sanofi collaboration revenue, along with strong growth from both Libtayo and EYLEA HD.

Third quarter diluted net income per share grew 70% to $20.07 and on net income of $2.2 billion. Beginning with the Sanofi collaboration, third quarter collaboration revenues reached an all-time high of $2.7 billion, including $2.6 billion from our share of collaboration profits. Our share of profits increased 77% versus the prior year, primarily driven by continued Dupixent net sales growth and the repayment of the Sanofi development balance, which was completed in the second quarter. Consequently, in the third quarter, we recorded our full share of collaboration profits for the first time. Under the recently amended antibody collaboration, Regeneron and Sanofi will share equally the development and commercialization costs of 4 next-generation antibodies. Since R&D costs will be co-funded as they are incurred, there will be no R&D development balance. Global profits from these antibodies will also be shared 50-50, while the existing economic terms for Dupixent and KEVZARA remain unchanged.

Regeneron expects to record the full $1 billion upfront payment as Sanofi collaboration revenue in the fourth quarter with any future milestone payments recognized in full in the period achieved. Moving to Bayer. Third quarter net sales of EYLEA 8 mg and EYLEA outside the U.S. were $643 million, inclusive of $384 million of EYLEA AMX sales. Total Bayer collaboration revenue was $267 million, of which $212 million related to our share of net profits outside the U.S. Other revenues in the third quarter increased 57% year-over-year to $310 million, including $253 million from our share of Alaris profits and Alaris royalties. Third quarter Alaris royalty revenue included an approximately $60 million cumulative catch-up adjustment reflecting the application of the highest royalty tier on year-to-date sales. This cumulative catch-up will not recur in the fourth quarter.

Now to our operating expenses. Third quarter R&D expense was $1.7 billion, driven by continued advancement of our broad clinical pipeline as well as the timing of related clinical manufacturing. Third quarter SG&A was $588 million, an increase of 9% year-over-year reflecting investments across our commercial organization and broader business. Our third quarter effective tax rate was 15%. The year-over-year increase was primarily due to a shift in the geographic mix of our pretax income driven by higher Sanofi collaboration revenue. Regeneron generated $2.9 billion of free cash flow through the first 9 months of 2026 and ended the quarter with $16.2 billion of cash and marketable securities net of debt. In the first 9 months of 2026, we deployed nearly $3 billion across share repurchases, business development and dividends. This included $2.3 billion to repurchase 3.2 million shares. We expect full year share repurchases to total approximately $3 billion. And as of September 30, we had $2.2 billion remaining under our repurchase authorization.

Moving to guidance. We made modest refinements to our 2026 financial guidance as we enter the last quarter of the year. A full summary of our guidance can be found in our earnings press release published earlier this morning. As we look to 2027, Len and George discuss the meaningful progress we are making across our innovative pipeline. We expect to advance multiple large registrational programs in myeloma anticoagulation, obesity and emerging mid-stage opportunities with significant revenue potential such as our programs in pots and mesh. This year alone, we are on pace to initiate more than 15 Phase III trials. We believe these investments can create substantial long-term value. To support this progress, we currently expect 2027 R&D expense to increase by a mid-teens percentage compared with 2026. Regarding our 2027 effective tax rate, we expect approximately 100 to 200 basis points of upward pressure relative to 2026, consistent with our prior long-term tax rate commentary.

Finally, turning to the new BARDA grant for Inmazeb. Beginning in late 2027, we expect to supply additional treatment doses to the U.S. government through 2031. Therefore, we do not anticipate recording any revenue in the fourth quarter of 2026 for Inmazeb. In conclusion, we delivered another outstanding quarter and remain well positioned to invest in our differentiated pipeline, delivering important medicines to patients and create durable long-term value for shareholders. With that, I'll pass the call back to Ryan.

Ryan Crowe

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

Operator

Our first question comes from the line of Salveen Richter with Goldman Sachs.

分析师问答

Elizabeth Webster

This is Elizabeth Webster on for Salveen. Just ahead of AASLD, could you further frame the clinical data from Side B we've seen to date in the context of the competitive landscape and expand upon where Regeneron would position this asset? And in your view, what are the key aspects of differentiation. Also noting you will speak about this at the roundtable. But any color you can share now would be appreciated.

George Yancopoulos

The other approach is to MASH and reducing liver fat are all somewhat indirect in that they are not directly addressing the fundamental genetic pathway that's underlying or driving this disease. They work, for example, by trying to decrease body weight for example, semaglutide or GLP, which lowers body weight, which then indirectly lowers liver fat. Similarly, the product from [indiscernible] works by a separate mechanism as well. This is the first pathway that directly involves a genetically validated target that is central to protecting the liver against multiple liver diseases including liver fat generated diseases.

Reflecting the genetics and the specificity and importance of this pathway the liver fat reductions that one is seeing here are unprecedented in the rapidity of onset and the depth of the liver fat reductions. As we said, they're on the order of 70% achieved in just a few weeks. And this is with a single dose lasting for a very long period of time. These are really game-changing results. And of course, highly supported with the genetics. So of course, we've reproduced now the genetic effects on liver fat. This gives us even more confidence that we're going to reduce the genetic effects on benefits in terms of liver disease. So this is really game-changing, unprecedented. There's nothing like this before for this disease.

And I think it's reflective of our approach to using large-scale human genetics to actually define the underlying mechanism of disease and not just come up with drugs that sort of accidentally or by chance, also benefited disease of interest but actually defining the underlying genetic pathway causing the disease directly targeting with one of our signature platforms, in this case, the siRNA approach and producing unprecedented results in these early stage data.

Ryan Crowe

Thanks, George. And we try look forward to highlighting that in a couple of weeks at our roundtable event on November 10.

Operator

Our next question comes from the line of Brian Abrahams with RBC Capital Markets.

Brian Abrahams

Wonder if you could talk a little bit more about the [indiscernible] and prelaunch activities, just kind of some of the learnings there as you prepare for the launch, now that you're closer to the approval and a potential label? And just how you're thinking about the initial target audience and uptake?

Marion McCourt

Sure. Very happy to make come in. So we certainly have a very talented neurology team at Regeneron. Very pleased with the caliber experience that the team has in neurology with other programs, and now we're really excited to bring that to Regeneron. As we mentioned, PDUFA date in November, very exciting. So launch activities, preparation are well underway. I'm not going to say a lot about launch strategy, but delighted to talk about it in the future. But I'm certainly sure everyone that we are launch ready. We look forward to the label and certainly bringing some distant into the marketplace is a really important enhancement for patients who need this treatment.

Ryan Crowe

Thanks, Marion. Let's move to the next question,.

Operator

Our next question comes from the line of Akash Tewari with Jefferies.

Akash Tewari

I noticed that your Sanofi collaboration allows you to add another early-stage Sanofi asset. Can we revisit static if the STAT6 oral start to deliver efficacy, not better, but let's just say, similar to Dupixent, would that be an asset that your team would be interested in adding to the ongoing collaboration with Sanofi?

Leonard Schleifer

Yes. So look, the alliance is open to doing anything and everything that makes sense to build on our expertise. I think the oral agents are an interesting class, but they're a long way from giving the efficacy and safety that Dupixent pathway blockers would get. You're talking -- as you further get away from the membrane and downstream, you always have to deal with other potential activities.

And frankly, when you get into longer dosing intervals, a daily pill doesn't afford much of an advantage in convenience and maybe even have to take it more than once compared to something that you might take once a quarter, once every 6 months. So the bottom line is, I think the alliance is open. We have a very good relationship now with Sanofi. I think we're back on a very strong track. [ Baylin Garijo ] has been really clear cut in helping us frame that we want to continue to build on DUPIXENT for a long time.

George Yancopoulos

Yes. I think we should add that certainly, there may be room for multiple treatment option and ways at dealing with the patients with so much high unmet need out there. But certainly, as Len said, an injectable that can be given 2 or 4 times a year, will certainly be an incredibly attractive option for so many patients whereas, of course, there may also be room for an oral pending, of course, dealing with the efficacy and, of course, safety issues that Len raised.

Operator

Our next question comes from the line of Tyler Van Buren with TD Cowen.

Tyler Van Buren

Congratulations on a very, very impressive quarter. So is it fair to say that Regeneron will become even more aggressive on the business development front than it was a year ago given the long-term new product revenue incentives stretching up to $30 billion to $40 billion/ And what stage of development is the ideal time to acquire external assets in your view? Is it post Phase II, so you can have a hand in operating the Phase III? Or is it post Phase III when you're closer to commercialization?

Leonard Schleifer

Yes. So Tyler, that's a great question. We do appreciate the 2 varies in your introductory remarks. I think our record show you've only given us one [indiscernible] in the past. So thank you for that. In terms of business development, look, we look at the overall spend on an investment, if you will, on research and development. And when you add up what other companies spend on external innovation and internal innovation and what we spend on internal and external innovation, these numbers, we're not out of line at all.

It's just that we have this incredibly productive research effort that George detailed a little bit that is producing things where some of the things we haven't even talked about and in the clinic yet are still even more exciting than you can imagine. So we are open to any and all opportunities at all stages. But as I said in my remarks, we're focused on the science. Does it really make sense? We love platforms if we can get platforms. But we have the firepower to do an advanced product or in early stage. So we are sort of agnostic. We don't really manage our BD that, hey, we need to fill a Phase II slot or a Phase III slot. We're looking for things that can make a difference to patients and build, and interact and be better with us than they might be by themselves.

George Yancopoulos

I think to add to what Len just said, I think that every company looks internally and externally and tries to evaluate which are the best opportunities for them to take on. And unfortunately, for most companies, they end up deciding that they have to look outside for the best opportunities compared to what's coming through the pipeline. As Len just described, most of the time, when we compare almost all external opportunities to what we have coming internally from our R&D engine we choose to focus to spend our resources on the internal opportunities when we compare them to what we get from the outside.

If you evaluate the track history of the industry in licensing outside opportunities, I think you would realize that our track record tends to outperform the industry standards for in-license by far.

Operator

Our next question comes from the line of June Lee with UBS.

Unknown Analyst

Congrats on a very strong quarter. You have 4 very promising next-gen dBs based on patent filings. Do you need just want to succeed? Or do you have plans -- different plans for different antibodies for different indications?

George Yancopoulos

That's a great question. I think that one of the reasons that we have these 4 assets is that we can actually imagine as you say, that some might be better tailored for one setting versus another setting. And so our development plan is certainly anticipating that possibility.

Operator

Our next question comes from the line of Tazeen Ahmad with Bank of America.

Tazeen Ahmad

I just wanted to get your updated view on the competitive landscape in AB, especially as it relates to next gen assets -- you've talked about the importance of having long-acting treatment. Do you think that's going to be sufficient to be competitive in the long run, just getting that others might also try to have similar dosing frequencies? Or do you think showing improved efficacy over due is also going to be needed?

Leonard Schleifer

I'll let [indiscernible] comment on the commercial side, but showing efficacy over due reminds me of the number of people that have tried to show efficacy over EYLEA over the last 15 years. Very difficult to do. And I think the same will be true for our Side B and other things that George talked about, because when you get to the heart of a problem, it's tough to really improve on mechanism. That said, I think while others might be able to do long acting as we are, there's room for multiple entries in this space, but very few will have the experience, the leverage, the capabilities that Sanofi and Regeneron put together with their experience with Dupi and [indiscernible] if you like...

George Yancopoulos

Well, let me just add one point to the competition. So -- and I think it's a really, really important point. In order to achieve long acting. If you look at the competition, they're using heavily human engineered versions of previously existing old antibodies that were generated decades ago. And when history shows, if you look across the industry, human engineering generally results in more problems than advances in terms of issues, for example, with and drug antibodies and so forth.

So our approach is, remember, depend on a very natural system, all derived naturally from our almost magical genetically engineered mouse that's fully humanized that delivers these requiring almost no human intervention and engineering. So history shows based on our own track record that our naturally derived antibodies tend to outperform heavily engineered antibodies. So while others are trying to do what we're doing, we'll have to see how these heavily engineered versions will compare to what we've historically delivered and tend to perform very well in patients. Go ahead, Marion.

Marion McCourt

So from commercialization, it's the platform that George and Len described on the differentiation of our science, which results in efficacy, safety and potential advancements on dosing frequency. But today, it starts with Dupixent. We're across 9 indications, age groups, geographies Dupixent time and time again has shown itself to be the product with best efficacy across type 2 diseases. Remarkable safety and tremendous results for patients. So from a commercialization standpoint, we look forward to these next programs. As George described, it all starts with the differentiation of our science.

Operator

Our next question comes from the line of Ellie Merle with Barclays.

Eliana Merle

Congrats on the quarter. MASH program, interesting on the 70% leverage at reduction, and we certainly agree that MASH is a very large opportunity curious your perspective on the antifibrotic mechanism that you might be seeing here? And how are you thinking about this in the context of the FGF21 class I guess from your look at the genetics, you point to a mechanistic rationale and [indiscernible] for cirrhosis or would you be focused more on the F2, F3 fibrosis setting.

And then you alluded to moving into registrational studies here. I know there's been an evolving discussion at the FDA on noninvasive markers versus histologic endpoints. Just curious your perspective and strategy here and thinking about the target patient population and potential next steps.

George Yancopoulos

It was a little hard to hear you, and there was a lot of questions in there. But the bottom line, and you can read our published data on the gene. In terms this pathway seems to protect against multiple aspects of liver disease, including that driven by fat, but by other mechanisms as well, with the effects represented in all facets of the resulting subsequent liver disease. So we feel that this mechanism may be getting at the heart and driving of many aspects of the liver disease that the world would like to be preventing and no other pathway has shown this sort of genetic protection profile.

So that's what makes it so exciting, together with the fact that the early clinical data actually are mirroring what we see genetically, which is giving us even more confidence in the genetics. In terms of registrational trials, as we said, we are moving aggressively forward in this program, and we'll be talking more at the November 10 roundtable where we can give you a lot more details.

Operator

Our next question comes from the line of Gregory Renza with Truth Securities.

Gregory Renza

Len, you certainly touched on along with the team, the advantageous breadth of your presence across specialties, therapeutic areas. Just my question is, at what stage do you see that versatility perhaps presenting a challenge or even a risk to the execution and the depth that you want Regeneron to have? And maybe relatedly, as you talk about [indiscernible] and opening up a 3,000-patient trial. To what extent are you and the team willing to make an investment in the vast obesity space and the resources enter in demand for winning there?

Leonard Schleifer

Very good question, Greg. It seems as though you may have been sitting in on some of our internal discussions. This is something that concerns us a lot. How do we make sure that are best-in-class opportunities and drugs get adequately developed, compete well, both in the development as well as commercialization. I can tell you we are very focused on that. But our experience matters. As I think we tried to get across, we have developed drugs for eye diseases, for cancer, for endocrinology, for ENT, for gastroenterology, for allergists and so forth, pulmonologists.

We have this experience of working with the specialists that we need to. We have a great diverse group that George leads internally. I think we can do it. It doesn't mean we're going to be perfect, but we are going to strive to anything we take on to hardly. And I think we do now have the experience that it's going to take. George, do you want to add to that?

George Yancopoulos

Yes. I remind you, not only are we working with all these specialists across these areas, in many, if not most of those cases, we have the world's leading biologic that's utilized by the specialists. And the reason why is a combination of the fact that we are providing what we believe is best-in-class, often first-in-class medicines for our commercial team to then explain and deliver to these various specialists. So when you talk about, for example, obesity, we don't want to just compete with just another obesity agent, where we're maybe fighting that we might have 1% or 2% more weight loss or something like that, we want to deliver once again something that's truly differentiated, and that's what we're striving to do.

For example, a weight loss agent that not only causes a similar weight loss -- or the other way loss agents, but also by a completely different mechanism of action dramatically lowers your lipids and your cardiovascular risk. We also have other approaches that we're combining with our obesity agent to prevent the profound loss of muscle that's caused by many of these obesity agents and on and on. So if we're entering the space, our goal is not to just compete commercially with the [indiscernible] . But to give our commercial group an agent that really makes a difference for patients, which they can then convey to the specialists that we're already dealing with, who have already seen our ability to deliver game-changing best-in-class medicines to their patients.

Ryan Crowe

Okay. Thank you. I think we have time for 2 more questions, Shannon.

Operator

Our next question comes from the line of Evan Seigerman with BMO Capital Markets.

Evan Seigerman

So the expanded Sanofi alliance, as I think for next-gen antibodies, focused on type 2 inflammation. What is the unmet need you're trying to solve that Dupixent cannot? And should we think about these programs primarily as franchise expansion, life cycle protection or ultimately replacement products?

Leonard Schleifer

Good question, Evan. I don't think this is the format where we really want to unveil our strategy. I think the alliance has some very interesting ideas. And I think you'll hear about them over time. Sorry to put that off, but I do think there's a better format for us to discuss this with Sanofi.

Ryan Crowe

Okay. Let's move to our final question, please, Shannon.

Operator

Our last question comes from the line of Alexandria Hammond with Wolf Research.

Alexandria Hammond

So on PNH, the [indiscernible] NGO Heart extension data versus ULTOMIRIS show some really strong data. If you continue to replicate those efficacy results in the upcoming readout against Solaris. What are your expectations on patients switching in the near term and steady state? I guess are there any nuances to this patient population, we've heard them being characterized as sticky.

Leonard Schleifer

Marion, do you want to take that?

Marion McCourt

Happy to. So I do think that the early clinical results have been very, very exciting and very compelling. But to the point, we'll have to see additional clinical data differentiation. But certainly, we will look forward to bringing this particular product and indication into the marketplace.

Ryan Crowe

Okay. Thanks, Marion. And thank you to everyone who dialed in for today's call. We apologize for those remaining in the Q&A queue who do not have a chance to ask their questions today. As always, the Investor Relations team is available to answer any questions that may remain. Thank you once again, and have a great day.

Operator

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