Pozelimab

Oral presentation to highlight activity of REGN7075 in combination with Libtayo from dose-escalation portion of trial in patients with microsatellite stable colorectal cancer, which has historically proven unresponsive to immunotherapy Ongoing REGN7075 Phase 1/2 trial is investigating a potentially first-in-class combination across a range of advanced solid tumors TARRYTOWN, N.Y., May 23, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive new results from an ongoing Phase 1/2 trial evaluating its first-in-class costimulatory bispecific antibody, REGN7075 (EGFRxCD28), in combination with Libtayo® (cemiplimab) in patients with advanced solid tumors. Data from the dose-escalation portion of the trial showed the investigational combination led to anti-tumor responses in patients with microsatellite stable colorectal cancer (MSS CRC). REGN7075 is one of the first immunotherapies to demonstrate clinical activity in MSS CRC, including in a patient with liver metastases. The results will be shared during an oral session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago. “Microsatellite stable colorectal cancer has historically been unresponsive to immunotherapy,” said Neil H. Segal, M.D., Ph.D., Medical Oncologist and Research Director in the Division of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center, and a trial investigator. “The early results for this novel investigational EGFRxCD28 costimulatory bispecific in combination with Libtayo are encouraging, showing anti-tumor responses in a highly difficult-to-treat cancer. This combination is one of the first immunotherapy regimens to show clinical activity in microsatellite stable colorectal cancer, and we are excited to advance this trial in additional tumor types.” In the dose-escalation portion of the trial, patients with metastatic and locally advanced solid tumors – who had exhausted standard treatment options, and most of whom also had liver metastases – received combination therapy with REGN7075 and Libtayo, following a REGN7075 monotherapy lead-in dose. Among 94 patients treated as of data cutoff, 65% (n=61) had MSS CRC, of which 51 MSS CRC patients were treated at an active dose level. Efficacy results among these 51 patients were as follows: 6% (n=3) overall response rate (ORR) and 29% (n=15) disease control rate (DCR). This included one complete response (CR), two partial responses (PR), and 12 patients with stable disease. At data cutoff, all responders were without liver metastases.Among the subset of 15 patients without liver metastases, there was a 20% ORR (n=3) and 80% DCR (n=12).Among the subset of 36 patients with liver metastases, three patients had stable disease as of data cutoff, and one patient achieved a PR following data cutoff. Safety was assessed in 84 patients across multiple solid tumor types at a variety of doses of REGN7075. REGN7075 and Libtayo showed an acceptable safety profile, and the maximum tolerated dose was not reached. Treatment-emergent adverse events (TEAEs) of any grade occurred in 98% of patients; Grade 3 and 4 TEAEs occurred in 35% of patients. Treatment-related adverse events (TRAEs) occurred in 90% of patients, with 7% of cases reported as grade 3 or 4. The majority of TRAEs were Grade 1 to 2 (83%), with the most common being infusion-related reactions (58%) that were manageable with premedication and dosing adjustments. TRAEs led to discontinuation in 5% of patients, and three patients discontinued treatment due to Grade 2 infusion-related reactions. As of data cutoff, there have been no dose-limiting toxicities, no reports of cytokine release syndrome, and no treatment-related deaths. “Regeneron is focused on developing a unique investigational portfolio of oncology medicines including checkpoint inhibitors, CD3 bispecifics and CD28 costimulatory bispecifics. Over the past several years, we have made progress in our programs across checkpoint inhibitors and the CD3 class and are now showing promising activity with two costimulatory bispecific antibodies,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Oncology at Regeneron. “Our costimulatory bispecifics were designed with the goal of turning cancer cells into antigen presenting cells, thereby converting historically immunotherapy unresponsive tumors from ‘cold’ to ‘hot’. These early data speak to the potential of REGN7075 in combination with Libtayo and add to a growing body of evidence supporting novel costimulatory bispecifics that are in clinical trials for a range of solid tumors and blood cancers.” The combination of REGN7075 and Libtayo is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority. While the dose escalation portion of the trial across multiple solid tumor types including non-small cell lung cancer, colorectal cancer, head and neck cancer and other tumor types is ongoing, expansion cohorts in several tumor types have also been initiated. About the Phase 1/2 TrialThe Phase 1/2, first-in-human, open-label trial investigating REGN7075 in combination with Libtayo is currently enrolling patients with metastatic and locally advanced solid tumors who have exhausted standard treatment options. The trial includes an ongoing Phase 1 dose-escalation portion and a Phase 2 dose-expansion period. In the Phase 1 dose-escalation portion, patients first receive a weekly lead-in dose of REGN7075 monotherapy for three weeks to assess its safety and efficacy alone. This is followed by treatment with combination therapy, with Libtayo dosed once every three weeks and REGN7075 dosed either every week or every three weeks. The primary endpoints are assessing safety and tolerability, while the secondary endpoints are assessing efficacy, pharmacokinetics and immunogenicity. Expansion cohorts in several tumor types have been initiated. For more information, visit the Regeneron clinical trials website, or contact via clinicaltrials@regeneron.com or 844-734-6643. About Regeneron in Cancer We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. About LibtayoLibtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in the European Union, Canada and Brazil. Libtayo is developed and marketed globally by Regeneron. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved IndicationsLibtayo is a prescription medicine used to treat: People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. It is not known if Libtayo is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS What is the most important information I should know about LIBTAYO?LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems: cough, shortness of breath, or chest painIntestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tendernessLiver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normalHormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulnessKidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetiteSkin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodesProblems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruisingInfusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swellingRejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have hadComplications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects. Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupushave received an organ transplanthave received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)have received radiation treatment to your chest areahave a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndromeare pregnant or plan to become pregnant. LIBTAYO can harm your unborn babyare breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatmentYou should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this timeTell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of LIBTAYO when used alone include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296. Please see full Prescribing Information, including Medication Guide. About Regeneron's VelocImmune TechnologyRegeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spend decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Dr. Segal has financial interests related to Regeneron Pharmaceuticals. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation REGN7075 in combination with Libtayo® (cemiplimab) and other of Regeneron’s Product Candidates discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as REGN7075 in combination with Libtayo in patients with advanced solid tumors and the other clinical programs discussed or referenced in the press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as REGN7075 in combination with Libtayo); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as REGN7075 in combination with Libtayo) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended March 31, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:Media RelationsTaylor SkottTel: +1 914-409-2381taylor.ramsey@regeneron.comInvestor RelationsVesna TosicTel: +1 914-847-5443vesna.tosic@regeneron.com

First quarter 2024 revenues decreased 1% to $3.15 billion versus first quarter 2023; excluding RonapreveTM(a)(b), revenuesincreased 7% First quarter 2024 Dupixent® global net sales(recorded by Sanofi) increased 24% to $3.08 billion versus first quarter 2023 First quarter 2024 U.S. net sales for EYLEA® HD and EYLEA® were $1.40 billion, including $200 million from EYLEA HD First quarter 2024 Libtayo® global net sales increased 45% to $264 million versus first quarter 2023 First quarter 2024 GAAP diluted EPS of $6.27 and non-GAAP diluted EPS(a) of $9.55 New $3.0 billion share repurchase program authorized in April 2024 TARRYTOWN, N.Y., May 02, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the first quarter of 2024 and provided a business update. "The Regeneron team has already made substantial progress this year, delivering our approved medicines to more patients around the globe, advancing our pipeline consisting of dozens of clinical-stage programs, and relentlessly pursuing cutting-edge science," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We had a strong quarter of EYLEA HD uptake, and we are well positioned to continue our leadership in retinal diseases. Dupixent continues to grow at a remarkable pace seven years into its launch and is currently treating over 850,000 patients across a variety of diseases characterized by type 2 inflammation. Our promising oncology franchise is strengthening, driven by strong global growth in Libtayo sales and potential regulatory approvals later this year for linvoseltamab in relapsed/refractory multiple myeloma." Financial Highlights ($ in millions, except per share data) Q1 2024 Q1 2023 % Change Total revenues $ 3,145 $ 3,162 (1% ) Total revenues excluding Ronapreve(a)(b) $ 3,145 $ 2,940 7% GAAP net income $ 722 $ 818 (12% ) GAAP net income per share - diluted $ 6.27 $ 7.17 (13% ) Non-GAAP net income(a) $ 1,116 $ 1,168 (4% ) Non-GAAP net income per share - diluted(a) $ 9.55 $ 10.09 (5% ) "We are off to a strong start in 2024 as reflected in our solid first quarter financial results and the progress we have made across our growing pipeline," said Christopher Fenimore, Senior Vice President, Finance and Chief Financial Officer of Regeneron. "While investing in innovation remains our top capital allocation priority, the recent authorization by Regeneron's board of directors of a new $3.0 billion share repurchase program provides us with additional flexibility to continue returning capital to shareholders over time." Business Highlights Key Pipeline Progress Regeneron has over 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: EYLEA HD (aflibercept) 8 mg In January 2024, the European Commission (EC) and Japan's Ministry of Health, Labour and Welfare (MHLW) each approved EYLEA 8 mg (known as EYLEA HD in the United States) for the treatment of patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). In January 2024, the United States Centers for Medicare & Medicaid Services (CMS) assigned a permanent and product-specific J-code (J0177) for EYLEA HD, which became effective on April 1, 2024. J-codes simplify and streamline the billing and reimbursement processes for Medicare Part B treatments, allowing for efficient claims processing. Dupixent (dupilumab) The U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. A regulatory application is also under review in the European Union (EU) and Japan. A Phase 3 study for Dupixent in asthma for children aged 2 to 5 years was initiated. In February 2024, the MHLW in Japan approved Dupixent for the treatment of chronic spontaneous urticaria (CSU) in adults and children aged 12 years and older whose disease is not adequately controlled with existing therapy. A regulatory application has also been submitted in the EU. Oncology Programs The FDA accepted the BLA seeking accelerated approval for linvoseltamab, a bispecific antibody targeting BCMA and CD3, to treat adult patients with relapsed/refractory (R/R) multiple myeloma that has progressed after at least three prior therapies, and the BLA was granted priority review with a target action date of August 22, 2024. A Phase 3 confirmatory trial is currently enrolling patients. A regulatory application is also under review in the EU. In April 2024, the Company presented positive pivotal data from the Phase 1/2 trial of linvoseltamab in patients with R/R multiple myeloma at the American Association for Cancer Research (AACR) Annual Meeting 2024. The linvoseltamab data reinforced previously shared findings and included a 71% objective response rate (ORR), with 46% of patients achieving a complete response (CR) or better. In March 2024, the FDA issued Complete Response Letters (CRLs) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). The only approvability issue cited in the CRLs is related to the enrollment status of the confirmatory trials. The CRLs (one for R/R FL and one for R/R DLBCL) did not identify any approvability issues with the clinical efficacy or safety, trial design, labeling, or manufacturing. A regulatory application for R/R DLBCL and R/R FL remains under review in the EU. In 2023, the Company initiated a Phase 2/3 study of the combination of fianlimab, an antibody to LAG-3, and Libtayo (cemiplimab) in first-line metastatic melanoma. This study is enrolling faster than expected and will be conducted solely as a Phase 3 study with the final analysis to be reported during 2025. Other Programs The FDA has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). A Phase 2 study for itepekimab, an antibody to IL-33, for non-cystic fibrosis bronchiectasis (NCFB) was initiated. A Phase 2 study for ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP), was initiated by the Company's collaborator Alnylam Pharmaceuticals, Inc. in patients with cerebral amyloid angiopathy (CAA). Corporate and Business Development Updates In April 2024, the Company acquired full development and commercialization rights to 2seventy bio, Inc.'s oncology and autoimmune preclinical and clinical stage cell therapy pipeline. Under the terms of the agreement, the Company made a $5 million up-front payment, and has assumed ongoing program, infrastructure, and personnel costs related to the product candidates acquired. In addition, the Company is obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product; and, with respect to any approved product, a low single-digit percent royalty on sales. In April 2024, the Company and Mammoth Biosciences, Inc. entered into a collaboration agreement to research, develop, and commercialize in vivo CRISPR-based gene editing therapies for multiple tissues and cell types. Under the terms of the agreement, the Company purchased an aggregate of $95 million of Mammoth preferred stock and is obligated to make a $5 million up-front payment. The parties will jointly select and research collaboration targets, and then Regeneron will lead development and commercialization. In April 2024, the Company's board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the Company's common stock. Repurchases may be made from time to time at management's discretion through a variety of methods. The program has no time limit and can be discontinued at any time. First Quarter 2024 Financial Results Revenues ($ in millions) Q1 2024 Q1 2023 % Change Net product sales: EYLEA HD - U.S. $ 200 $ — * EYLEA - U.S. 1,202 1,434 (16% ) Total EYLEA HD and EYLEA - U.S. 1,402 1,434 (2% ) Libtayo - Global 264 177 49% Praluent - U.S. 70 40 75% Evkeeza® - U.S. 24 15 60% Inmazeb® - Global 1 2 * Total net product sales 1,761 1,668 6% Collaboration revenue: Sanofi 910 798 14% Bayer 356 357 —% Other 1 223 (100% ) Other revenue 117 116 1% Total revenues $ 3,145 $ 3,162 (1% ) * Percentage not meaningful Net product sales of EYLEA in the U.S. decreased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to changing market dynamics, resulting in lower volumes and a lower net selling price. In addition, aggregate net product sales of EYLEA and EYLEA HD in the first quarter of 2024 were negatively impacted by approximately $40 million due to a sequential net reduction in wholesaler inventory. Sanofi collaboration revenue increased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to the Company's share of profits from commercialization of antibodies, which were $804 million in the first quarter of 2024, compared to $637 million in the first quarter of 2023. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales. The decrease in other collaboration revenue in the first quarter of 2024, compared to the first quarter of 2023, was due to lower sales of Ronapreve. Under the Company's Roche collaboration agreement, the Company records collaboration revenue in connection with payments from Roche attributable to gross profits from sales of Ronapreve; however, the Company does not expect any additional Roche collaboration revenue from Ronapreve in future periods. Refer to Table 4 for a summary of collaboration revenue. Operating Expenses GAAP % Change Non-GAAP(a) % Change ($ in millions) Q1 2024 Q1 2023 Q1 2024 Q1 2023 Research and development (R&D) $ 1,248 $ 1,101 13% $ 1,122 $ 960 17% Acquired in-process research and development (IPR&D) $ 7 $ 56 (88% ) * * n/a Selling, general, and administrative (SG&A) $ 689 $ 601 15% $ 584 $ 515 13% Cost of goods sold (COGS) $ 240 $ 208 15% $ 196 $ 168 17% Cost of collaboration and contract manufacturing (COCM) $ 193 $ 249 (22% ) * * n/a Other operating expense (income), net $ 15 $ (1 ) ** $ — * ** * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded. ** Percentage not meaningful GAAP and non-GAAP R&D expenses increased in the first quarter of 2024, compared to the first quarter of 2023, driven by the advancement of the Company's late-stage oncology programs, and higher headcount and headcount-related costs. Acquired IPR&D for first quarter of 2023 included a $45 million up-front payment in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc. GAAP and non-GAAP SG&A expenses increased in the first quarter of 2024, compared to the first quarter of 2023, due to higher commercialization-related expenses to support the Company's launch of EYLEA HD and higher headcount and headcount-related costs primarily related to the international expansion in support of Libtayo and hematology product launch preparations. GAAP and non-GAAP COGS increased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to higher start-up costs for the Company's Rensselaer, New York fill/finish facility. COCM decreased in the first quarter of 2024, compared to the first quarter of 2023, primarily due to lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process. GAAP other operating expense (income), net, for the first quarter of 2024 reflects a charge related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with the Company's 2023 acquisition of Decibel Therapeutics, Inc. Other Financial Information GAAP other income (expense) included the recognition of net unrealized losses on equity securities of $196 million in the first quarter of 2024, compared to $165 million of net unrealized losses in the first quarter of 2023. GAAP and Non-GAAP other income (expense) also included interest income of $162 million in the first quarter of 2024, compared to $95 million in the first quarter of 2023. In the first quarter of 2024, the Company's GAAP effective tax rate (ETR) was (3.0%), compared to 4.7% in the first quarter of 2023. The GAAP ETR in the first quarter of 2024, compared to the first quarter of 2023, included a higher benefit from stock-based compensation. In the first quarter of 2024, the non-GAAP ETR was 6.1%, compared to 9.7% in the first quarter of 2023. GAAP net income per diluted share was $6.27 in the first quarter of 2024, compared to $7.17 in the first quarter of 2023. Non-GAAP net income per diluted share was $9.55 in the first quarter of 2024, compared to $10.09 in the first quarter of 2023. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. During the first quarter of 2024, the Company repurchased shares of its common stock and recorded the cost of the shares, or $298 million, as Treasury Stock. As of March 31, 2024, $1.2 billion remained available for share repurchases under the Company's share repurchase program then in effect (excluding the additional $3.0 billion share repurchase program authorized in April 2024). 2024 Financial Guidance(c) The Company's full year 2024 financial guidance consists of the following components: 2024 Guidance Prior Updated GAAP R&D $4.820–$5.070 billion $4.920–$5.170 billion** Non-GAAP R&D(a) $4.300–$4.500 billion $4.400–$4.600 billion** GAAP SG&A $2.890–$3.090 billion $2.940–$3.090 billion Non-GAAP SG&A(a) $2.500–$2.650 billion $2.550–$2.650 billion GAAP gross margin on net product sales(d) 86%–88% Unchanged Non-GAAP gross margin on net product sales(a)(d) 89%–91% Unchanged COCM(e)* $850–$910 million Unchanged Capital expenditures* $825–$950 million $780–$880 million GAAP effective tax rate 8%–10% 7%–9% Non-GAAP effective tax rate(a) 10%–12% Unchanged * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded. ** Updates to GAAP and non-GAAP amounts reflect ongoing program, infrastructure, and personnel costs assumed in connection with the acquisition of 2seventy bio's preclinical and clinical pipeline as described above. A reconciliation of full year 2024 GAAP to non-GAAP financial guidance is included below: Projected Range ($ in millions) Low High GAAP R&D $ 4,920 $ 5,170 Stock-based compensation expense 510 540 Acquisition and integration costs 10 30 Non-GAAP R&D $ 4,400 $ 4,600 GAAP SG&A $ 2,940 $ 3,090 Stock-based compensation expense 350 380 Acquisition and integration costs 40 60 Non-GAAP SG&A $ 2,550 $ 2,650 GAAP gross margin on net product sales 86% 88% Stock-based compensation expense 1% 1% Intangible asset amortization expense 1% 1% Acquisition and integration costs <1% <1% Non-GAAP gross margin on net product sales 89% 91% GAAP ETR 7% 9% Income tax effect of GAAP to non-GAAP reconciling items 3% 3% Non-GAAP ETR 10% 12% (a) This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other operating (income) expense, net, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, total revenues excluding Ronapreve, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. (b) The casirivimab and imdevimab antibody cocktail for COVID-19 is known as REGEN-COV in the United States and Ronapreve in other countries. Roche records net product sales of Ronapreve outside the United States. (c) The Company's 2024 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. (d) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. (e) Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2024 financial and operating results on Thursday, May 2, 2024, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron's website at Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Regeneron Pharmaceuticals, Inc. Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook, or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA® HD (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, NTLA-2001, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2023 and its Form 10-Q for the quarterly period ended March 31, 2024. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( ) and its LinkedIn page ( ). Non-GAAP Financial Measures This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures. Contact Information: Ryan Crowe Christina Chan Investor Relations Corporate Affairs 914-847-8790 914-847-8827 ryan.crowe@regeneron.com christina.chan@regeneron.com TABLE 1 REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In millions) March 31, December 31, 2024 2023 Assets: Cash and marketable securities $ 17,498.3 $ 16,241.3 Accounts receivable, net 5,222.2 5,667.3 Inventories 2,714.9 2,580.5 Property, plant, and equipment, net 4,225.5 4,146.4 Intangible assets, net 1,058.7 1,038.6 Deferred tax assets 2,764.9 2,575.4 Other assets 885.1 830.7 Total assets $ 34,369.6 $ 33,080.2 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $ 3,972.7 $ 3,818.6 Finance lease liabilities 720.0 720.0 Deferred revenue 702.5 585.6 Long-term debt 1,983.3 1,982.9 Stockholders' equity 26,991.1 25,973.1 Total liabilities and stockholders' equity $ 34,369.6 $ 33,080.2 TABLE 2 REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In millions, except per share data) Three Months Ended March 31, 2024 2023 Revenues: Net product sales $ 1,761.3 $ 1,668.0 Collaboration revenue 1,266.8 1,378.1 Other revenue 116.9 116.0 3,145.0 3,162.1 Expenses: Research and development 1,248.4 1,101.2 Acquired in-process research and development 7.1 56.1 Selling, general, and administrative 689.0 601.1 Cost of goods sold 240.4 208.4 Cost of collaboration and contract manufacturing 193.4 249.1 Other operating expense (income), net 15.3 (0.5 ) 2,393.6 2,215.4 Income from operations 751.4 946.7 Other income (expense): Other (expense) income, net (34.6 ) (70.7 ) Interest expense (16.1 ) (18.0 ) (50.7 ) (88.7 ) Income before income taxes 700.7 858.0 Income tax (benefit) expense (21.3 ) 40.2 Net income $ 722.0 $ 817.8 Net income per share - basic $ 6.70 $ 7.64 Net income per share - diluted $ 6.27 $ 7.17 Weighted average shares outstanding - basic 107.8 107.1 Weighted average shares outstanding - diluted 115.1 114.0 TABLE 3 REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (In millions, except per share data) Three Months Ended March 31, 2024 2023 GAAP R&D $ 1,248.4 $ 1,101.2 Stock-based compensation expense 123.0 139.5 Acquisition and integration costs 3.8 1.6 Non-GAAP R&D $ 1,121.6 $ 960.1 GAAP SG&A $ 689.0 $ 601.1 Stock-based compensation expense 86.2 76.8 Acquisition and integration costs 18.8 9.6 Non-GAAP SG&A $ 584.0 $ 514.7 GAAP COGS $ 240.4 $ 208.4 Stock-based compensation expense 20.9 22.4 Acquisition and integration costs 0.4 — Intangible asset amortization expense 23.2 18.5 Non-GAAP COGS $ 195.9 $ 167.5 GAAP other operating expense (income), net $ 15.3 $ (0.5 ) Change in fair value of contingent consideration 15.3 — Non-GAAP other operating expense (income), net $ — $ (0.5 ) GAAP other income (expense), net $ (50.7 ) $ (88.7 ) Losses on investments, net 196.1 166.6 Non-GAAP other income (expense), net $ 145.4 $ 77.9 GAAP net income $ 722.0 $ 817.8 Total of GAAP to non-GAAP reconciling items above 487.7 435.0 Income tax effect of GAAP to non-GAAP reconciling items (93.8 ) (85.3 ) Non-GAAP net income $ 1,115.9 $ 1,167.5 Non-GAAP net income per share - basic $ 10.35 $ 10.90 Non-GAAP net income per share - diluted $ 9.55 $ 10.09 Shares used in calculating: Non-GAAP net income per share - basic 107.8 107.1 Non-GAAP net income per share - diluted 116.8 115.7 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) Three Months Ended March 31, 2024 2023 Revenue reconciliation: Total revenues $ 3,145.0 $ 3,162.1 Global gross profit payment from Roche in connection with sales of Ronapreve 0.5 222.2 Total revenues excluding Ronapreve $ 3,144.5 $ 2,939.9 Effective tax rate reconciliation: GAAP ETR (3.0% ) 4.7% Income tax effect of GAAP to non-GAAP reconciling items 9.1% 5.0% Non-GAAP ETR 6.1% 9.7% Free cash flow reconciliation: Net cash provided by operating activities $ 1,512.5 $ 1,367.6 Capital expenditures (133.9 ) (178.2 ) Free cash flow $ 1,378.6 $ 1,189.4 TABLE 4 REGENERON PHARMACEUTICALS, INC. COLLABORATION REVENUE (Unaudited) (In millions) Three Months Ended March 31, 2024 2023 Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $ 804.0 $ 636.5 Reimbursement for manufacturing of commercial supplies 105.8 161.9 Total Sanofi collaboration revenue 909.8 798.4 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 333.9 331.6 Reimbursement for manufacturing of ex-U.S. commercial supplies 22.1 25.3 Total Bayer collaboration revenue 356.0 356.9 Other collaboration revenue: Global gross profit payment from Roche in connection with sales of Ronapreve 0.5 222.2 Other 0.5 0.6 Total collaboration revenue $ 1,266.8 $ 1,378.1 TABLE 5 REGENERON PHARMACEUTICALS, INC. NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions) Three Months Ended March 31, 2024 2023 % Change U.S. ROW(g) Total U.S. ROW Total (Total Sales) EYLEA HD and EYLEA(a) $ 1,401.6 $ 849.4 $ 2,251.0 $ 1,433.8 $ 847.1 $ 2,280.9 (1 %) Dupixent(b) $ 2,218.0 $ 858.8 $ 3,076.8 $ 1,898.1 $ 586.9 $ 2,485.0 24 % Libtayo(c) $ 159.2 $ 104.7 $ 263.9 $ 109.7 $ 72.9 $ 182.6 45 % Praluent(d) $ 70.0 $ 131.3 $ 201.3 $ 40.2 $ 105.7 $ 145.9 38 % Kevzara(b) $ 50.0 $ 44.1 $ 94.1 $ 39.2 $ 39.3 $ 78.5 20 % REGEN-COV(e) $ — $ 1.2 $ 1.2 $ — $ 613.2 $ 613.2 (100 %) Other products(f) $ 25.3 $ 17.7 $ 43.0 $ 18.1 $ 16.5 $ 34.6 24 % (a) Regeneron records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States. (b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products. (c) Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States and pays Sanofi a royalty on global sales. Included in this line item for the first quarter of 2023 is approximately $6 million of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period). (d) Regeneron records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales. (e) Roche records net product sales outside the United States and the parties share gross profits from sales based on a pre-specified formula. (f) Included in this line item are products which are sold by the Company and others. Refer to "First Quarter 2024 Financial Results" section above for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST®, which are recorded by Kiniksa; net product sales of ARCALYST were $71 million for the fourth quarter of 2023. (g) Rest of world (ROW)