Follicular Lymphoma

18 presentations across five cancer types include new insights on the potential of checkpoint inhibitors and bispecific antibodies TARRYTOWN, N.Y. , May 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, IL. Eighteen presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. “Our broad oncology and hematology programs are uniquely designed to investigate regimens that could provide meaningful impact for people living with difficult-to-treat cancers across all stages of the treatment paradigm,” said George D. Yancopoulos , M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron . “Our PD-1 inhibitor Libtayo is the standard of care in advanced cutaneous squamous cell carcinoma, and in clinical trials, our investigational BCMAxCD3 bispecific antibody linvoseltamab has demonstrated a compelling profile in relapsed or refractory multiple myeloma. At ASCO, our presentations showcase how we are seeking to further transform the treatment of these diseases with updates from two key programs – our Phase 3 trial exploring adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma and early data from investigational combinations of linvoseltamab and different proteasome inhibitors in third-line or higher multiple myeloma.” Notable presentations at ASCO on Regeneron’s oncology pipeline include detailed efficacy and safety findings from the Phase 3 C-POST trial evaluating the adjuvant use of the PD-1 inhibitor Libtayo in post-surgical high-risk cutaneous squamous cell carcinoma (CSCC). The results will be presented in an oral session on Saturday, May 31 . In hematology, Regeneron will debut results from two cohorts of the LINKER-MM2 trial, which is exploring combinations of linvoseltamab, Regeneron’s investigational BCMAxCD3 bispecific antibody. These include combinations of linvoseltamab with carfilzomib or bortezomib in relapsed/refractory (R/R) multiple myeloma (MM) after at least two lines of therapy, which will be featured in two rapid oral presentations on Monday, June 2 . In addition, the results of a cooperative group study reporting on the primary analysis of a randomized Phase 2 trial of vidutolimod in combination with an anti-PD-1 versus anti-PD-1 as neoadjuvant therapy in stage 3 resectable melanoma will be presented in an oral session on Tuesday, June 3 . Vidutolimod is a toll like receptor 9 antagonist that was acquired by Regeneron in 2022. The full list of Regeneron presentations at ASCO includes: The potential uses of Libtayo in adjuvant CSCC, fianlimab, REGN7075, vidutolimod, and the combinations with linvoseltamab described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. Fianlimab, REGN7075 and vidutolimod are not currently approved for use in any indication. Odronextamab is conditionally approved as Ordspono™ in the European Union for the treatment of R/R follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority. Linvoseltamab is conditionally approved as Lynozyfic™ in the European Union for the treatment of adult patients with R/R multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority. The U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Applications for linvoseltamab and odronextamab with respective target action dates for FDA decisions of July 10, 2025 and July 30, 2025 . 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. Libtayo 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. 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 pain Intestinal 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 tenderness Liver 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 normal Hormone 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 forgetfulness Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite Skin 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 nodes Problems 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 bruising Infusion 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 swelling Rejection 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 had Complications, 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 lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatment You 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 time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO are 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 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 Technology Regeneron '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 spent 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 Dupixent® (dupilumab), Libtayo, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. About RegeneronRegeneron (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. 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 Libtayo® (cemiplimab) and Regeneron’s Product Candidates discussed or referenced in this press release (such as linvoseltamab, REGN7075, fianlimab, and odronextamab); 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 adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma, linvoseltamab (as a monotherapy or in combination with other cancer treatments discussed or referenced in this press release) in relapsed/refractory (“R/R”) multiple myeloma, REGN7075 in combination with Libtayo and chemotherapy in non-small cell lung cancer (“NSCLC”), fianlimab in combination with Libtayo in perioperative melanoma or NSCLC, odronextamab in R/R follicular lymphoma, 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 those referenced above); 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 and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) 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 or copay assistance for Regeneron’s Products from third-party payors and other third parties, 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 payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); 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 on Regeneron 's business; and risks associated with 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 ), 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), 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, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025 . 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). Source: Regeneron Pharmaceuticals, Inc.

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today reports 2025 first quarter financial results, and provides a status update on the Company’s clinical development portfolio. "The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We also continued to advance our innovative pipeline, which will be critical for driving long-term growth. The positive Phase 3 results for povorcitinib in hidradenitis suppurativa in addition to the proof-of-concept in chronic spontaneous urticaria, strengthens the potential of povorcitinib as a multibillion-dollar product addressing patient needs across the five indications currently in development.” Key Commercial Highlights Jakafi® (ruxolitinib): Net product revenues for the first quarter 2025 of $709 million (+24% Y/Y): Opzelura® (ruxolitinib) cream: Net product revenues for the first quarter 2025 of $119 million (+38% Y/Y): Pipeline Updates Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights MPN and GVHD Programs Indication and status Ruxolitinib XR (QD) (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD Ruxolitinib + INCB57643 (JAK1/JAK2 + BETi) Myelofibrosis: Phase 2 Ruxolitinib + axatilimab1 (JAK1/JAK2 + anti-CSF-1R) Chronic GVHD: Phase 2 Steroids + axatilimab1 (Steroids + anti-CSF-1R) Chronic GVHD: Phase 3 INCA33989 (mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1 INCB160058 (JAK2V617Fi) Myelofibrosis: Phase 1 1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. Other Hematology/Oncology – key highlights Heme/Oncology Programs Indication and status Tafasitamab (Monjuvi®/Minjuvi®) (CD19) Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory follicular lymphoma (FL): Phase 3 (inMIND) Retifanlimab (Zynyz®)1 (PD-1) Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) INCB123667 (CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1 INCB161734 (KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1 INCA33890 (TGFßR2×PD-1)2 Advanced or metastatic solid tumors: Phase 1 1 Retifanlimab licensed from MacroGenics. 2 Development in collaboration with Merus. Inflammation and Autoimmunity (IAI) – key highlights Ruxolitinib Cream Povorcitinib (INCB54707) IAI and Dermatology Programs Indication and status Ruxolitinib cream (Opzelura)1 (JAK1/JAK2) Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3) Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025 Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2) Povorcitinib (JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 3 (STOP-V1, STOP-V2) Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2) Chronic spontaneous urticaria: Phase 2 Asthma: Phase 2 INCA034460 (anti-CD122) Vitiligo: Phase 1 1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration. Other - key highlights In February 2025, Incyte and Genesis Therapeutics, Inc. (Genesis) entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte. Incyte receives exclusive rights to develop and commercialize collaboration products leveraged through Genesis’ GEMS artificial intelligence (AI) platform. Other Program Indication and Phase Zilurgisertib (ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2 2025 First Quarter Financial Results The financial measures presented in this press release for the three months ended March 31, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 Total GAAP revenues $ 1,052,898 $ 880,889 Total GAAP operating income 205,168 91,898 Total Non-GAAP operating income 283,641 161,183 GAAP net income 158,203 169,548 Non-GAAP net income 229,459 132,719 GAAP basic EPS $ 0.82 $ 0.76 Non-GAAP basic EPS $ 1.18 $ 0.59 GAAP diluted EPS $ 0.80 $ 0.75 Non-GAAP diluted EPS $ 1.16 $ 0.58 Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended March 31, % Change (as reported) % Change (constant currency)1 2025 2024 Net product revenues: Jakafi $ 709,412 $ 571,839 24 % NA Opzelura 118,705 85,724 38 % 39 % Iclusig 29,544 30,343 (3 %) — % Pemazyre 18,440 17,676 4 % 6 % Minjuvi/ Monjuvi 29,551 23,874 24 % 25 % Niktimvo 13,613 — NM NA Zynyz 3,009 467 544 % NA Total net product revenues 922,274 729,923 26 % 27 % Royalty revenues: Jakavi 92,145 89,595 3 % 6 % Olumiant 30,800 30,589 1 % 6 % Tabrecta 6,413 5,234 23 % NA Other 1,266 548 131 % NM Total royalty revenues 130,624 125,966 4 % Total net product and royalty revenues 1,052,898 855,889 23 % Milestone and contract revenues — 25,000 — % — % Total GAAP revenues $ 1,052,898 $ 880,889 20 % NM = not meaningful NA = not applicable 1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results. Product and Royalty Revenues Total net product and royalty revenues for the quarter ended March 31, 2025 increased 23% over the prior year comparative period. Total net product revenues for the quarter ended March 31, 2025 increased 26% over the prior year comparative period primarily driven by the following: Jakafi net product revenue increased 24% versus the prior year comparable period, driven by an increase in paid demand of 10% reflecting continued demand growth in all indications, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and 7% favorable impact from less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025. Opzelura net product revenue increased 38% due to continued growth in new patient starts and refills in the U.S. with U.S. paid demand up 24% versus the first quarter of 2024, partially offset by a reduction in channel inventory, and increased contribution from ex-U.S. driven by continued uptake in Germany and France, as well as growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the first quarter of 2025. Minjuvi/Monjuvi net product revenue increased 24% as a result of the first quarter of 2025 reflecting three months of net product revenues in the U.S., compared to two months of net product revenue in the first quarter of 2024 due to the acquisition of U.S. rights to Monjuvi, which closed in February 2024. Niktimvo net product revenue driven by the commercial launch of the product during the first quarter of 2025. Operating Expenses Operating Expense Summary (unaudited, in thousands) Three Months Ended March 31, % Change 2025 2024 GAAP cost of product revenues $ 73,188 $ 60,956 20 % Non-GAAP cost of product revenues1 66,945 54,959 22 % GAAP research and development 437,279 429,260 2 % Non-GAAP research and development2 400,020 388,437 3 % GAAP selling, general and administrative 325,691 300,256 8 % Non-GAAP selling, general and administrative3 302,292 277,335 9 % GAAP loss (gain) on change in fair value of acquisition-related contingent consideration 11,572 (456 ) NM Non-GAAP loss (gain) on change in fair value of acquisition-related contingent consideration — — — % GAAP (profit) and loss sharing under collaboration agreements — (1,025 ) — % 1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. 2 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient severance payments. 3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient severance payments. Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended March 31, 2025 increased 20% and 22% respectively, compared to the same period in 2024 primarily due to increased royalty expense. Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2025 increased 2% and 3%, respectively, compared to the same period in 2024, reflecting continued investment in our late stage development assets and timing of certain expenses. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2025 increased 8% and 9%, respectively, compared to the same period in 2024 primarily due to timing of consumer marketing activities and of certain other expenses. Other Financial Information Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended March 31, 2025, compared to the same period in 2024, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig. Operating income GAAP and Non-GAAP operating income for the three months ended March 31, 2025 increased 123% and 76%, respectively, compared to the same period in 2024, driven primarily by growth in net product revenue. Cash, cash equivalents and marketable securities position As of March 31, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.4 billion and $2.2 billion, respectively. 2025 Financial Guidance Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its full year 2025 Jakafi revenue guidance. Guidance for Opzelura includes net product revenue for pediatric atopic dermatitis which has an anticipated approval in the second half of 2025. Guidance for other oncology net product revenues include net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma. Approvals for these indications are anticipated in the second half of 2025. Guidance for research and development excludes the $15 million of expense for the full year 2025 related to our recently announced collaboration with Genesis. Current Previous Jakafi net product revenues $2,950 - $3,000 million $2,925 - $2,975 million Opzelura net product revenues Unchanged $630 - $670 million Other oncology net product revenues(1) Unchanged $415 - $455 million GAAP Cost of product revenues Unchanged 8.5% - 9.0% of net product revenues Non-GAAP Cost of product revenues(2) Unchanged 7.5% - 8.0% of net product revenues GAAP Research and development expenses Unchanged $1,930 - $1,960 million Non-GAAP Research and development expenses(3) Unchanged $1,780 - $1,805 million GAAP Selling, general and administrative expenses Unchanged $1,280 - $1,310 million Non-GAAP Selling, general and administrative expenses(3) Unchanged $1,160 - $1,185 million 1Pemazyre in the U.S., EU and Japan; Niktimvo, Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU. 2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation. 3Adjusted to exclude the estimated cost of stock-based compensation. Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13753168. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13753168. The conference call will also be webcast live and can be accessed at investor.incyte.com. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. About Jakafi® (ruxolitinib) Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Monjuvi® (tafasitamab-cxix) Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. Following accelerated approval by the U.S. Food and Drug Administration in July 2020, Monjuvi® (tafasitamab-cxix) is being commercialized in the United States by Incyte. In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in August 2021. XmAb® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are (registered) trademarks of Incyte. About Pemazyre® (pemigatinib) Pemazyre® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre is a trademark of Incyte. About Iclusig® (ponatinib) tablets Iclusig® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Zynyz® (retifanlimab-dlwr) Zynyz® (retifanlimab) is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a trademark of Incyte. About Niktimvo™ (axatilimab-csfr) Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s potential for continued performance and growth; Incyte’s ability to achieve both its full-year and long-term objectives; Incyte’s financial guidance for 2025, including its expectations regarding sales of and demand for Jakafi and Opzelura; expected revenue contribution from Niktimvo and additional near-term launches; the potential of povorcitinib to be a multibillion-dollar product; the possibility for 2025 to be a transformational year for Incyte in terms of launches, phase 3 study initiations, pivotal readouts and proof of concept readouts; Incyte’s potential to have more than 10 high impact launches by 2030; the potential and progress of programs in our pipeline; ongoing clinical trials and clinical trials that may be initiated; expectations regarding discussions with regulators, regulatory submissions and regulatory approvals; plans to present data at upcoming medical conferences; Incyte’s exposure to potential tariffs; and 2025 newsflow items. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA, EMA and other regulatory agencies; Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte’s products and the products of Incyte’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products and the products of Incyte’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 GAAP Revenues: Product revenues, net $ 922,274 $ 729,923 Product royalty revenues 130,624 125,966 Milestone and contract revenues — 25,000 Total revenues 1,052,898 880,889 Costs, expenses and other: Cost of product revenues (including definite-lived intangible amortization) 73,188 60,956 Research and development 437,279 429,260 Selling, general and administrative 325,691 300,256 Loss (gain) on change in fair value of acquisition-related contingent consideration 11,572 (456 ) (Profit) and loss sharing under collaboration agreements — (1,025 ) Total costs, expenses and other 847,730 788,991 Income from operations 205,168 91,898 Interest income 22,929 46,770 Interest expense (660 ) (430 ) (Loss) gain on equity investments (1,343 ) 99,947 Other, net 8,096 (2,026 ) Income before provision for income taxes 234,190 236,159 Provision for income taxes 75,987 66,611 Net income $ 158,203 $ 169,548 Net income per share: Basic $ 0.82 $ 0.76 Diluted $ 0.80 $ 0.75 Shares used in computing net income per share: Basic 193,712 224,484 Diluted 198,197 227,219 INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) March 31, 2025 December 31, 2024 ASSETS Cash, cash equivalents and marketable securities $ 2,408,658 $ 2,158,092 Accounts receivable 823,134 853,154 Property and equipment, net 765,359 763,411 Finance lease right-of-use assets, net 29,892 30,803 Inventory 429,286 407,199 Prepaid expenses and other assets 243,470 181,382 Equity investments 17,463 18,814 Other intangible assets, net 107,611 113,803 Goodwill 155,593 155,593 Deferred income tax asset 768,899 762,071 Total assets $ 5,749,365 $ 5,444,322 LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable, accrued expenses and other liabilities $ 1,849,681 $ 1,765,733 Finance lease liabilities 37,121 37,961 Acquisition-related contingent consideration 195,000 193,000 Stockholders’ equity 3,667,563 3,447,628 Total liabilities and stockholders’ equity $ 5,749,365 $ 5,444,322 INCYTE CORPORATION RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 GAAP Net Income $ 158,203 $ 169,548 Adjustments1: Non-cash stock compensation from equity awards (R&D)2 36,724 36,792 Non-cash stock compensation from equity awards (SG&A)2 23,399 22,373 Non-cash stock compensation from equity awards (COGS)2 859 613 Non-cash interest3 82 108 Loss (gain) on equity investments4 1,343 (99,947 ) Amortization of acquired product rights5 5,384 5,384 Loss (gain) on change in fair value of contingent consideration6 11,572 (456 ) MorphoSys transition costs7 — 4,579 Escient acquisition related compensation expense8 535 — Tax effect of Non-GAAP pre-tax adjustments9 (8,642 ) (6,275 ) Non-GAAP Net Income $ 229,459 $ 132,719 Non-GAAP net income per share: Basic $ 1.18 $ 0.59 Diluted $ 1.16 $ 0.58 Shares used in computing Non-GAAP net income per share: Basic 193,712 224,484 Diluted 198,197 227,219 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2025 are milestones of $0 earned from our collaborative partners, as compared to $25,000 of milestones earned for the three months ended March 31, 2024. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2025 and 2024 are upfront consideration and milestones of $15,500 and $1,000, respectively, related to our collaborative partners. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the (Loss) gain on equity investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the Loss (gain) on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $4,031 for the three months ended March 31, 2024, and $548 is included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2024. MorphoSys transition costs primarily represent employee related costs to transition research and development and selling, general and administrative activities to us under the former collaboration agreement with MorphoSys. 8 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $535 for the three months ended March 31, 2025. Escient acquisition related compensation expense represents non-recurring charges associated with severance payments to former Escient employees. 9 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. The Non-GAAP net income for the three months ended March 31, 2024 should have been $132,719 compared to the $145,269 previously disclosed to correct a transposition error in the tax effect of Non-GAAP pre-tax adjustments. For the three months ended March 31, 2024, the tax effect of Non-GAAP pre-tax adjustments should have been ($6,275) instead of $6,275. This correction is reflected in the table above.

First quarter 2025 revenues of $3.0 billion; GAAP diluted EPS of $7.27 and non-GAAP diluted EPS(a) of $8.22First quarter 2025 Dupixent® global net sales (recorded by Sanofi) increased 19% to $3.67 billion versus first quarter 2024First quarter 2025 EYLEA HD® U.S. net sales increased 54% to $307 million versus first quarter 2024; total EYLEA HD and EYLEA® U.S. net sales decreased 26% to $1.04 billion Dupixent approved for chronic spontaneous urticaria (CSU) in U.S.; approved for chronic obstructive pulmonary disease (COPD) in JapanFDA accepted for priority review EYLEA HD sBLA for both retinal vein occlusion (RVO) and for monthly dosing in approved indications; update provided on FDA review of EYLEA HD pre-filled syringe submissionLynozyfic™ (linvoseltamab) approved in EU for relapsed/refractory multiple myelomaRegulatory applications submitted for Libtayo® in adjuvant cutaneous squamous cell carcinoma (CSCC) in U.S. and EUAnnounced ongoing and planned investments in New York and North Carolina infrastructure and manufacturing expected to total more than $7 billion TARRYTOWN, N.Y., April 29, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the first quarter of 2025 and provided a business update. "Regeneron has one of the most exciting pipelines in the industry, with unmatched diversity, scientific distinction, and potential to help millions of patients," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We are laser focused on fulfilling the promise of this pipeline by advancing our clinical programs, and expect several important data readouts this year. We are also working to ensure our four blockbuster medicines reach even more patients who could benefit, with year-to-date progress including regulatory approvals for Dupixent in CSU in the U.S. and COPD in Japan." Financial Highlights ($ in millions, except per share data) Q1 2025 Q1 2024 % ChangeTotal revenues $3,029 $3,145 (4%)GAAP net income $809 $722 12%GAAP net income per share - diluted $7.27 $6.27 16%Non-GAAP net income(a) $928 $1,116 (17%)Non-GAAP net income per share - diluted(a) $8.22 $9.55 (14%) "We have made meaningful progress across our pipeline so far in 2025, including four regulatory approvals, nine regulatory submissions, and are poised to report pivotal or proof-of-concept data across programs in immunology, oncology, hematology, internal medicine, and rare diseases later this year," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We continue to deploy capital with the goal of maximizing long-term shareholder value, with a focus on internal investment in our research, development, and commercial capabilities, along with returning capital directly to our shareholders through opportunistic share repurchases and our dividend program, which we initiated earlier this year." Business Highlights Key Pipeline ProgressRegeneron has approximately 45 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent (dupilumab) In April 2025, the U.S. Food and Drug Administration (FDA) approved Dupixent for the treatment of adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment.In March 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) approved Dupixent for the treatment of patients with COPD.The Company and Sanofi presented positive results from the pivotal Phase 2/3 trial in adults with moderate-to-severe bullous pemphigoid at the 2025 American Academy of Dermatology (AAD) Annual Meeting. In February 2025, the FDA accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent in bullous pemphigoid, with a target action date of June 20, 2025. A regulatory application has also been submitted in the European Union (EU). EYLEA HD (aflibercept) 8 mg In April 2025, the FDA accepted for priority review an sBLA for both the treatment of macular edema following RVO, and broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA target action date is August 19, 2025, following the use of a priority review voucher.The FDA issued a Complete Response Letter (CRL) for the EYLEA HD pre-filled syringe on April 23, 2025. The Company held several teleconferences with the FDA to better understand the contents of the CRL, and believes the key outstanding issue relates to a question posed by the FDA to a third-party component supplier. This component supplier has expeditiously responded to FDA requests for information. The CRL did not identify any issues with the safety or efficacy of EYLEA HD, the usability of the device, proposed labelling, or pre-approval inspection findings.In April 2025, the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals. The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks. The Company is evaluating the FDA’s decision.The Company presented positive results from the Phase 3 QUASAR trial for the treatment of patients with macular edema following RVO, including those with central, branch, and hemiretinal vein occlusions, at the Angiogenesis, Exudation, and Degeneration (Angiogenesis) 2025 annual meeting.The Company announced positive three-year (156-week) results from an extension study of the Phase 3 PULSAR trial in patients with wet age-related macular degeneration (wAMD). Similar to the three-year results for the pivotal PHOTON trial in diabetic macular edema (DME), the longer-term wAMD data demonstrated the vast majority of patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year, while also achieving substantially longer treatment intervals. The results were presented at the Angiogenesis 2025 annual meeting. Oncology Programs The Company submitted an sBLA to the FDA and a regulatory application in the EU for Libtayo (cemiplimab) in adjuvant CSCC based upon data from a Phase 3 trial which demonstrated that adjuvant treatment with Libtayo was the first and only immunotherapy that led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk CSCC after surgery.The FDA accepted for review the resubmission of the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory (R/R) follicular lymphoma, with a target action date of July 30, 2025.The FDA accepted for review the resubmission of the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in R/R multiple myeloma, with a target action date of July 10, 2025.The European Commission (EC) granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with R/R multiple myeloma. The indication is specific to those who have received at least three prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.Enrollment was completed in a Phase 3 confirmatory trial (LINKER-MM3) for linvoseltamab in R/R multiple myeloma. Other Programs The Company presented updated data from the Phase 1/2 trial of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene at the Association for Research in Otolaryngology’s (ARO) 48th Annual MidWinter Meeting. The data showed that 11 out of 12 children treated demonstrated a notable response, with improved hearing at various decibel hearing levels. This included updated results from the first child dosed, who received treatment at 10 months of age and at 48 weeks post-treatment showed continued near-normal levels of hearing, as well as formal speech perception improvements between 48- and 72-weeks post-treatment.A Phase 3 study for itepekimab, an antibody to IL-33, in chronic rhinosinusitis with nasal polyposis (CRSwNP) was initiated.A Phase 2 study for REGN5381, an agonist antibody to NPR1, in uncontrolled hypertension was initiated.A Phase 2 study for REGN7544, an antagonist antibody to NPR1, in sepsis-induced hypotension was initiated.The FDA granted Orphan Drug designation for mibavademab, an agonist antibody to leptin receptor (LEPR), in generalized lipodystrophy; a Phase 3 study is ongoing. Corporate Updates The Company reached resolution of its patent infringement litigation related to Biocon’s EYLEA (aflibercept) Injection 2 mg biosimilar product. The settlement precludes Biocon from launching its biosimilar product in the United States until the second half of 2026. All intellectual property-related litigation with Biocon in the United States has been dismissed.The Company announced a 10-year agreement with FUJIFILM Diosynth Biotechnologies (Fujifilm) to manufacture and supply Regeneron's commercial bulk drug product at Fujifilm's North Carolina campus. The agreement is anticipated to nearly double the Company's large-scale manufacturing capacity in the United States. First Quarter 2025 Financial Results Revenues ($ in millions) Q1 2025 Q1 2024 % ChangeNet product sales: EYLEA HD - U.S. $307 $200 54%EYLEA - U.S. 736 1,202 (39%)Total EYLEA HD and EYLEA - U.S. 1,043 1,402 (26%)Libtayo - U.S. 192 159 21%Libtayo - ROW** 93 105 (11%)Total Libtayo - Global 285 264 8%Praluent® - U.S. 57 70 (19%)Evkeeza® - U.S. 31 24 29%Inmazeb® - ROW — 1 (100%)Total net product sales 1,416 1,761 (20%) Collaboration revenue: Sanofi 1,183 910 30%Bayer 344 356 (3%)Other 4 1 *Other revenue 82 117 (30%)Total revenues $3,029 $3,145 (4%) * Percentage not meaningful** Rest of world (ROW) Net product sales of EYLEA HD increased in the first quarter of 2025, compared to the first quarter of 2024, primarily due to higher sales volumes. Net product sales of EYLEA in the first quarter of 2025, compared to the first quarter of 2024, were negatively impacted by (i) lower volume as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price. In addition, total EYLEA and EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2025 compared to the end of the fourth quarter of 2024. Total EYLEA and EYLEA HD net product sales decreased 30% on a sequential basis; however, physician unit demand decreased sequentially by 11%. EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents. Sanofi collaboration revenue increased in the first quarter of 2025, compared to the first quarter of 2024, due to an increase in the Company's share of profits from the commercialization of antibodies, which were $1.018 billion and $804 million in the first quarter of 2025 and 2024, respectively. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales. Refer to Table 4 for a summary of collaboration revenue. Operating Expenses GAAP % Change Non-GAAP(a) % Change($ in millions) Q1 2025 Q1 2024 Q1 2025 Q1 2024 Research and development (R&D) $1,327 $1,248 6% $1,186 $1,122 6%Acquired in-process research and development (IPR&D) $12 $7 71% * * n/aSelling, general, and administrative (SG&A) $633 $689 (8%) $537 $584 (8%)Cost of goods sold (COGS) $266 $240 11% $217 $196 11%Gross margin on net product sales(c) 81% 86% 85% 89% Cost of collaboration and contract manufacturing (COCM) $199 $193 3% * * n/aOther operating expense (income), net $— $15 (100%) * $— —% * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded GAAP and non-GAAP R&D expenses increased in the first quarter of 2025, compared to the first quarter of 2024, driven by the advancement of the Company's clinical pipeline and higher personnel-related costs.GAAP and non-GAAP gross margin on net product sales was adversely impacted by higher inventory write-offs and reserves in the first quarter of 2025 compared to the first quarter of 2024. Other Financial Information GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of $140 million in the first quarter of 2025, compared to $196 million of net unrealized losses in the first quarter of 2024. In the first quarter of 2025, the Company's GAAP effective tax rate (ETR) was 10.6%, compared to (3.0%) in the first quarter of 2024. The GAAP ETR increased in the first quarter of 2025, compared to the first quarter of 2024, due to lower tax benefits from less stock option exercises. In the first quarter of 2025, the non-GAAP ETR was 11.6%, compared to 6.1% in the first quarter of 2024. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. Capital Allocation In February 2025, 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. During the first quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $1.052 billion, as Treasury Stock. As of March 31, 2025, an aggregate of $3.874 billion remained available for share repurchases under the Company's share repurchase programs. In April 2025, the Company's board of directors declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on June 6, 2025 to shareholders of record as of May 20, 2025. 2025 Financial Guidance(b) The Company's full year 2025 financial guidance consists of the following components: 2025 Guidance Prior UpdatedGAAP R&D $5.560–$5.795 billion UnchangedNon-GAAP R&D(a) $5.000–$5.200 billion UnchangedGAAP SG&A $2.910–$3.095 billion UnchangedNon-GAAP SG&A(a) $2.550–$2.700 billion UnchangedGAAP gross margin on net product sales 84%–85% 83%–84%Non-GAAP gross margin on net product sales(a) 87%–88% 86%–87%COCM(d)* $1.000–$1.150 billion UnchangedCapital expenditures* $850–$975 million $850–$950 millionGAAP effective tax rate 9%–11% UnchangedNon-GAAP effective tax rate(a) 11%–13% Unchanged * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below: Projected Range($ in millions) Low HighGAAP R&D $5,560 $5,795 Stock-based compensation expense 560 590 Acquisition and integration costs — 5 Non-GAAP R&D $5,000 $5,200 GAAP SG&A $2,910 $3,095 Stock-based compensation expense 360 390 Acquisition and integration costs — 5 Non-GAAP SG&A $2,550 $2,700 GAAP gross margin on net product sales 83% 84% Intangible asset amortization expense 2% 2% Stock-based compensation expense 1% 1% Non-GAAP gross margin on net product sales 86% 87% GAAP ETR 9% 11% Income tax effect of GAAP to non-GAAP reconciling items 2% 2% Non-GAAP ETR 11% 13% (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, 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 flow, 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, the non-GAAP measures presented are intended to 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 Company's 2025 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. (c)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. (d)Corresponding reimbursements from collaborators and others for manufacturing product is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2025 financial and operating results on Tuesday, April 29, 2025, 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 www.regeneron.com. 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 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 www.regeneron.com 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, competing drugs and product candidates that may be superior to, or more cost effective than, 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") (including biosimilar versions of Regeneron's Products); 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 or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and 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), Ordspono™ (odronextamab), Lynozyfic™ (linvoseltamab), itepekimab, fianlimab, garetosmab, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), REGN5713-5715, nexiguran ziclumeran (nex-z, NTLA-2001), REGN1908-1909, mibavademab, 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; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; 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 or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor 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 payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; 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 on Regeneron's business; and risks associated with 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), 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), 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, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. 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). 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 ChanInvestor Relations Corporate Affairs914-847-8790 914-847-8827ryan.crowe@regeneron.com christina.chan@regeneron.com TABLE 1 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In millions) March 31, December 31, 2025 2024Assets: Cash and marketable securities $17,625.7 $17,912.6Accounts receivable, net 5,561.0 6,211.9Inventories 3,192.4 3,087.3Property, plant, and equipment, net 4,694.2 4,599.7Intangible assets, net 1,167.0 1,148.6Deferred tax assets 3,442.9 3,314.1Other assets 1,862.0 1,485.2Total assets $37,545.2 $37,759.4 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $4,621.7 $4,888.0Finance lease liabilities 720.0 720.0Deferred revenue 831.1 813.4Long-term debt 1,984.8 1,984.4Stockholders' equity 29,387.6 29,353.6Total liabilities and stockholders' equity $37,545.2 $37,759.4 TABLE 2 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In millions, except per share data) Three Months Ended March 31, 2025 2024 Revenues: Net product sales $1,415.6 $1,761.3 Collaboration revenue 1,531.2 1,266.8 Other revenue 81.9 116.9 3,028.7 3,145.0 Expenses: Research and development 1,327.4 1,248.4 Acquired in-process research and development 12.3 7.1 Selling, general, and administrative 633.0 689.0 Cost of goods sold 265.5 240.4 Cost of collaboration and contract manufacturing 198.8 193.4 Other operating expense (income), net — 15.3 2,437.0 2,393.6 Income from operations 591.7 751.4 Other income (expense): Other income (expense), net 322.0 (34.6)Interest expense (8.7) (16.1) 313.3 (50.7) Income before income taxes 905.0 700.7 Income tax expense (benefit) 96.3 (21.3) Net income $808.7 $722.0 Net income per share - basic $7.58 $6.70 Net income per share - diluted $7.27 $6.27 Weighted average shares outstanding - basic 106.7 107.8 Weighted average shares outstanding - diluted 111.2 115.1 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, 2025 2024 GAAP R&D $1,327.4 $1,248.4 Stock-based compensation expense 141.0 123.0 Acquisition and integration costs — 3.8 Non-GAAP R&D $1,186.4 $1,121.6 GAAP SG&A $633.0 $689.0 Stock-based compensation expense 95.2 86.2 Acquisition and integration costs 0.8 18.8 Non-GAAP SG&A $537.0 $584.0 GAAP COGS $265.5 $240.4 Stock-based compensation expense 19.5 20.9 Acquisition and integration costs — 0.4 Intangible asset amortization expense 28.7 23.2 Non-GAAP COGS $217.3 $195.9 GAAP other operating expense (income), net $— $15.3 Change in fair value of contingent consideration — 15.3 Non-GAAP other operating expense (income), net $— $— GAAP other income (expense), net $313.3 $(50.7)(Gains) losses on investments, net (139.9) 196.1 Non-GAAP other income (expense), net $173.4 $145.4 GAAP net income $808.7 $722.0 Total of GAAP to non-GAAP reconciling items above 145.3 487.7 Income tax effect of GAAP to non-GAAP reconciling items (25.6) (93.8)Non-GAAP net income $928.4 $1,115.9 Non-GAAP net income per share - basic $8.70 $10.35 Non-GAAP net income per share - diluted $8.22 $9.55 Shares used in calculating: Non-GAAP net income per share - basic 106.7 107.8 Non-GAAP net income per share - diluted 113.0 116.8 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) Three Months Ended March 31, 2025 2024 Effective tax rate reconciliation: GAAP ETR 10.6% (3.0%)Income tax effect of GAAP to non-GAAP reconciling items 1.0% 9.1%Non-GAAP ETR 11.6% 6.1% Gross margin on net product sales reconciliation: GAAP gross margin on net product sales 81% 86%Intangible asset amortization expense 2% 2%Stock-based compensation expense 2% 1%Non-GAAP gross margin on net product sales 85% 89% Free cash flow reconciliation: Net cash provided by operating activities $1,045.1 $1,512.5 Capital expenditures (229.3) (133.9)Free cash flow $815.8 $1,378.6 TABLE 4 REGENERON PHARMACEUTICALS, INC.COLLABORATION REVENUE (Unaudited)(In millions) Three Months Ended March 31, 2025 2024Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $1,018.2 $804.0Reimbursement for manufacturing of commercial supplies 165.0 105.8Total Sanofi collaboration revenue 1,183.2 909.8 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 317.3 333.9Reimbursement for manufacturing of commercial supplies 26.6 22.1Total Bayer collaboration revenue 343.9 356.0 Other collaboration revenue 4.1 1.0 Total collaboration revenue $1,531.2 $1,266.8 TABLE 5 REGENERON PHARMACEUTICALS, INC.NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)(In millions) Three Months Ended March 31, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales)EYLEA HD(a) $306.8 $146.4 $453.2 $200.0 $15.2 $215.2 111%EYLEA(a) $736.0 $711.4 $1,447.4 $1,201.6 $834.2 $2,035.8 (29%)Total EYLEA HD and EYLEA $1,042.8 $857.8 $1,900.6 $1,401.6 $849.4 $2,251.0 (16%)Dupixent(b) $2,629.4 $1,036.2 $3,665.6 $2,218.0 $858.8 $3,076.8 19%Libtayo(c) $192.5 $92.6 $285.1 $159.2 $104.7 $263.9 8%Praluent(d) $56.8 $136.5 $193.3 $70.0 $131.3 $201.3 (4%)Kevzara(b) $72.8 $43.6 $116.4 $50.0 $44.1 $94.1 24%Other products(e) $31.1 $23.5 $54.6 $25.3 $18.9 $44.2 24% Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below.(a) The Company 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 within Collaboration revenue.(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 within Collaboration revenue(c) The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales(d) The Company 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, which is recorded within Other revenue.(e) Included in this line item are products which are sold by the Company and others. Refer to "First Quarter 2025 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.