- Fourth quarter 2024 revenues increased 10% to $3.79 billion versus fourth quarter 2023
- Full year 2024 revenues increased 8% to $14.20 billion versus 2023; excluding RonapreveTM(a)(b), revenues increased 10%
- Fourth quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 15% to $3.70 billion versus fourth quarter 2023; full year 2024 Dupixent global net sales increased 22% to $14.15 billion versus 2023
- Fourth quarter 2024 U.S. net sales for EYLEA HD® and EYLEA® increased 2% versus fourth quarter 2023 to $1.50 billion, including $305 million from EYLEA HD; full year 2024 U.S. net sales for EYLEA HD and EYLEA increased 1% versus 2023 to $5.97 billion versus 2023, including $1.20 billion from EYLEA HD
- Fourth quarter 2024 Libtayo® global net sales increased 50% to $367 million versus fourth quarter 2023; full year 2024 Libtayo global net sales increased 40% to $1.22 billion versus 2023
- Fourth quarter 2024 GAAP diluted EPS of $8.06 and non-GAAP diluted EPS(a) of $12.07; fourth quarter 2024 includes unfavorable $0.11 impact from acquired IPR&D charge
- Initiation of quarterly cash dividend program, $0.88 dividend declared; additional $3.0 billion share repurchase program authorized, bringing current repurchase capacity to ~$4.5 billion
- Regulatory applications submitted to FDA for EYLEA HD pre-filled syringe, Dupixent in bullous pemphigoid, odronextamab in follicular lymphoma, and linvoseltamab in multiple myeloma
- Positive Phase 3 results reported for EYLEA HD in retinal vein occlusion (RVO) and Libtayo in high-risk adjuvant cutaneous squamous cell carcinoma (CSCC)
"Regeneron's financial and commercial strength allows for continued investment in our industry-leading R&D pipeline, while simultaneously returning capital to our shareholders through our newly initiated dividend program and increased share repurchase capacity," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "In 2025, we will continue to focus on our four blockbuster medicines as we progress our approximately 40 investigational candidates covering dozens of disease states with expansive market potential."
Financial Highlights
| ($ in millions, except per share data) | Q4 2024 | Q4 2023 | % Change | FY 2024 | FY 2023 | % Change | ||||||||||||
| Total revenues | $ | 3,789 | $ | 3,434 | 10 | % | $ | 14,202 | $ | 13,117 | 8 | % | ||||||
| GAAP net income | $ | 918 | $ | 1,160 | (21 | %) | $ | 4,413 | $ | 3,954 | 12 | % | ||||||
| GAAP net income per share - diluted | $ | 8.06 | $ | 10.19 | (21 | %) | $ | 38.34 | $ | 34.77 | 10 | % | ||||||
| Non-GAAP net income(a) | $ | 1,390 | $ | 1,366 | 2 | % | $ | 5,319 | $ | 5,045 | 5 | % | ||||||
| Non-GAAP net income per share - diluted(a) | $ | 12.07 | $ | 11.86 | 2 | % | $ | 45.62 | $ | 43.79 | 4 | % | ||||||
Business Highlights
Key Pipeline Progress
Regeneron has approximately 40 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
- The Company announced that the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD for the treatment of patients with macular edema following RVO, including those with central, branch, and hemiretinal vein occlusions. In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA, the current standard of care. The Company plans to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025.
- A regulatory application for a pre-filled syringe was submitted to the FDA, with an FDA decision expected by mid-2025.
- In November 2024, the European Commission (EC) approved Dupixent to treat eosinophilic esophagitis (EoE) in children aged 1 to 11 years, making Dupixent the first and only medicine indicated to treat these young patients.
- The FDA accepted for review the resubmission of an sBLA for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment, with a target action date of April 18, 2025.
- An sBLA for Dupixent in bullous pemphigoid was submitted to the FDA.
- A Phase 3 study in lichen simplex chronicus was initiated.
- The Company announced positive results from a Phase 3 trial of Libtayo, 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.
- A Phase 3 study of Libtayo administered intralesionally in patients with early-stage CSCC was initiated.
- In January 2025, the Company resubmitted to the FDA the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in relapsed/refractory (R/R) multiple myeloma following resolution of third-party manufacturing issues.
- In January 2025, the Company resubmitted to the FDA the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma.
- The Company presented new and updated data for odronextamab spanning several B-cell non-Hodgkin lymphoma (B-NHL) subtypes across earlier lines of treatment at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
- The Company announced positive Phase 2 results for two antibodies targeting distinct domains of Factor XI. REGN7508 (catalytic domain) is designed to maximize anticoagulant activity while minimizing bleeding risk, and REGN9933 (A2 domain) is designed to provide an additional option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Per the Phase 2 results, there was a robust antithrombotic effect for each antibody, and no clinically relevant bleeding was observed.
- The Company announced positive updated data from a Phase 3 study of pozelimab (C5 antibody), in combination with cemdisiran (siRNA therapy), against ravulizumab, a standard-of-care C5 inhibitor, in patients with paroxysmal nocturnal hemoglobinuria (PNH). The study showed that the combination treatment helped patients achieve and maintain greater disease control, compared to ravulizumab. These results were presented at the 66th ASH Annual Meeting and Exposition.
- The EC approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR) and polyarticular juvenile idiopathic arthritis (pJIA).
- A Phase 3 study for mibavademab, an agonist antibody to leptin receptor (LEPR), in generalized lipodystrophy was initiated.
- Enrollment was completed in a Phase 2 study in obesity for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide with and without garetosmab, an antibody to Activin A.
- A Phase 2 study for itepekimab, an antibody to IL-33, in chronic rhinosinusitis without nasal polyposis (CRSsNP) was initiated.
- A Phase 2 study for REGN7544, an antagonist antibody to NPR1, in postural orthostatic tachycardia syndrome (POTS) was initiated.
- The Company shared initial data from the first patient in a Phase 1 study of linvoseltamab, in combination with Dupixent, in severe food allergy at the 43rd Annual J.P. Morgan Healthcare Conference.
- In February 2025, the Company's board of directors approved the initiation of a quarterly cash dividend program and declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on March 20, 2025 to shareholders of record as of February 20, 2025. The Company intends to pay a cash dividend on a quarterly basis going forward, subject to market conditions and approval by the Company's board of directors in its sole discretion.
- In February 2025, the Company's board of directors also authorized an additional $3.0 billion share repurchase program, bringing the total current capacity to approximately $4.5 billion. 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.
- In January 2025, the Company entered into an agreement with Truveta Inc. pursuant to which the Company will sequence exomes and conduct genotyping and imputation of up to ten million de-identified consented volunteers using biospecimens provided by Truveta health system members across the United States.
- The Company announced its inclusion on the Dow Jones Sustainability World Index (DJSI World) for the sixth consecutive year, as well as its fifth consecutive inclusion on the Dow Jones Sustainability North America Index (DJSI North America).
| Programs | Milestones | |||
| EYLEA HD | - | Submit sBLA in RVO (first quarter 2025) and FDA decision on sBLA (second half 2025) | ||
| - | FDA decision for pre-filled syringe (mid-2025) | |||
| - | FDA decision on sBLA with two-year data for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) (target action date of April 20, 2025) | |||
| - | Submit sBLA for every 4-week dosing regimen (first quarter 2025) and FDA decision on sBLA (second half 2025) | |||
| Immunology & Inflammation | - | Report results from Phase 3 study for itepekimab (IL-33 antibody) in chronic obstructive pulmonary disease (COPD) (second half 2025) and submit BLA (second half 2025) | ||
| - | FDA decision on sBLA for Dupixent in CSU (target action date of April 18, 2025) | |||
| - | sBLA acceptance for Dupixent in bullous pemphigoid (first half 2025) and FDA decision on sBLA (second half 2025); regulatory submission in European Union (EU) (first half 2025) | |||
| - | Initiate additional Phase 3 studies for itepekimab (IL-33 antibody) (first half 2025) | |||
| - | Report additional data from Phase 1 study for linvoseltamab (BCMA and CD3 bispecific antibody) in combination with Dupixent in severe food allergies | |||
| Solid Organ Oncology | - | Submit sBLA for Libtayo in adjuvant CSCC (first half 2025) | ||
| - | Report results from Phase 3 study of fianlimab (LAG-3 antibody), in combination with Libtayo, versus pembrolizumab in first-line metastatic melanoma (second half 2025) and submit BLA (second half 2025) | |||
| - | Report initial Phase 2 data for fianlimab (LAG-3 antibody) in combination with Libtayo in first-line advanced non-small cell lung cancer (NSCLC) (first half 2025) | |||
| - | Report additional data for ubamatamab (MUC16 and CD3 bispecific antibody) in ovarian cancer | |||
| - | Report additional data from solid tumor costimulatory bispecific antibody programs | |||
| Hematology | - | FDA decision on BLA for odronextamab (CD20 and CD3 bispecific antibody) in R/R follicular lymphoma (second half 2025) | ||
| - | FDA decision on BLA for linvoseltamab (BCMA and CD3 bispecific antibody) in R/R multiple myeloma (mid-2025) | |||
| - | Initiate Phase 3 program for Factor XI antibodies (REGN9933 and REGN7508) | |||
| Genetic Medicines | - | Report additional data from Phase 1/2 study for DB-OTO (AAV-based gene therapy) in patients with hearing deficit due to variants of the otoferlin gene (mid-2025) | ||
| - | Report results from Phase 3 study for pozelimab (C5 antibody) in combination with cemdisiran in myasthenia gravis (second half 2025) | |||
| Internal Medicine | - | Report results from Phase 2 study for semaglutide in combination with trevogrumab (myostatin antibody) with and without garetosmab (Activin A antibody) in obesity (second half 2025) | ||
| - | Report results from Phase 2 study for mibavademab (LEPR agonist antibody) in combination with tirzepatide in obesity (second half 2025) | |||
| - | Report results from Phase 3 study for garetosmab (Activin A antibody) in fibrodysplasia ossificans progressiva (FOP) (second half 2025) |
Fourth Quarter and Full Year 2024 Financial Results
Revenues
| ($ in millions) | Q4 2024 | Q4 2023 | % Change | FY 2024 | FY 2023 | % Change | ||||||||||||
| Net product sales: | ||||||||||||||||||
| EYLEA HD - U.S. | $ | 305 | $ | 123 | 148 | % | $ | 1,201 | $ | 166 | * | |||||||
| EYLEA - U.S. | 1,190 | 1,338 | (11 | %) | 4,767 | 5,720 | (17 | %) | ||||||||||
| Total EYLEA HD and EYLEA - U.S. | 1,495 | 1,461 | 2 | % | 5,968 | 5,886 | 1 | % | ||||||||||
| Libtayo - Global | 367 | 244 | 50 | % | 1,217 | 863 | 41 | % | ||||||||||
| Praluent®- U.S. | 63 | 61 | 3 | % | 242 | 182 | 33 | % | ||||||||||
| Evkeeza®- U.S. | 38 | 24 | 58 | % | 126 | 77 | 64 | % | ||||||||||
| Inmazeb®- U.S. | 40 | 62 | (35 | %) | 76 | 70 | 9 | % | ||||||||||
| Total net product sales | 2,003 | 1,852 | 8 | % | 7,629 | 7,078 | 8 | % | ||||||||||
| Collaboration revenue: | ||||||||||||||||||
| Sanofi | 1,213 | 993 | 22 | % | 4,531 | 3,800 | 19 | % | ||||||||||
| Bayer | 377 | 377 | - | % | 1,499 | 1,487 | 1 | % | ||||||||||
| Other | 17 | - | * | 28 | 216 | (87 | %) | |||||||||||
| Other revenue | 179 | 212 | (16 | %) | 515 | 536 | (4 | %) | ||||||||||
| Total revenues | $ | 3,789 | $ | 3,434 | 10 | % | $ | 14,202 | $ | 13,117 | 8 | % | ||||||
| Total revenues excluding Ronapreve(a) | $ | 3,789 | $ | 3,436 | 10 | % | $ | 14,201 | $ | 12,906 | 10 | % | ||||||
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