(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
(Address of Principal Executive Offices, including zip code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Date: February 2, 2024 | REGENERON PHARMACEUTICALS, INC. | ||||||||||
By: | /s/ Joseph J. LaRosa | ||||||||||
Name: | Joseph J. LaRosa | ||||||||||
Title: | Executive Vice President, General Counsel and Secretary |
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||||||||||||||||
($ in millions, except per share data) | 2023 | 2022 | % Change | 2023 | 2022 | % Change | ||||||||||||||||||||||||||||||||
Total revenues | $ | 3,434 | $ | 3,414 | 1 | % | $ | 13,117 | $ | 12,173 | 8 | % | ||||||||||||||||||||||||||
Total revenues excluding Ronapreve(a)(b) | $ | 3,436 | $ | 3,018 | 14% | $ | 12,906 | $ | 11,546 | 12% | ||||||||||||||||||||||||||||
GAAP net income | $ | 1,160 | $ | 1,197 | (3 | %) | $ | 3,954 | $ | 4,338 | (9 | %) | ||||||||||||||||||||||||||
GAAP net income per share - diluted | $ | 10.19 | $ | 10.50 | (3 | %) | $ | 34.77 | $ | 38.22 | (9 | %) | ||||||||||||||||||||||||||
Non-GAAP net income(a) | $ | 1,366 | $ | 1,449 | (6 | %) | $ | 5,045 | $ | 5,164 | (2 | %) | ||||||||||||||||||||||||||
Non-GAAP net income per share - diluted(a) | $ | 11.86 | $ | 12.56 | (6 | %) | $ | 43.79 | $ | 44.98 | (3 | %) |
Programs | Milestones | |||||||||||||
Ophthalmology | - | Initiate pivotal retinal vein occlusion (RVO) study of EYLEA HD (mid-2024) to enable FDA submission | ||||||||||||
- | Initiate pivotal studies of pozelimab (C5 antibody) in combination with cemdisiran (siRNA therapy) in geographic atrophy (second half 2024) | |||||||||||||
Immunology & Inflammation | - | EC decision on regulatory submission for Dupixent for EoE in children (1–11 years of age) (second half 2024) | ||||||||||||
- | sBLA acceptance for Dupixent in COPD with type 2 inflammatory phenotype (first quarter 2024) and FDA decision on sBLA (mid/second half 2024); EC decision on regulatory submission (second half 2024) | |||||||||||||
- | Report results from ongoing Phase 3 study for Dupixent in chronic spontaneous urticaria (CSU) in biologic-naïve patients (fourth quarter 2024) | |||||||||||||
- | Initiate Phase 1 study in severe food allergy following transient linvoseltamab treatment (in combination with Dupixent) (2024) | |||||||||||||
- | Complete enrollment of Phase 3 studies of itepekimab (IL-33 antibody) in COPD (second half 2024) | |||||||||||||
Solid Organ Oncology | - | Conduct interim analysis from Phase 3 study of Libtayo in adjuvant cutaneous squamous cell carcinoma (CSCC) (second half 2024) | ||||||||||||
- | Report potentially pivotal initial results from Phase 2/3 study of fianlimab (LAG-3 antibody) in combination with Libtayo in first-line metastatic melanoma and initial combination data in first-line advanced non-small cell lung cancer (NSCLC) (second half 2024) | |||||||||||||
- | Initiate potentially pivotal Phase 2 study for fianlimab (in combination with Libtayo) in perioperative melanoma and Phase 2 study for fianlimab (in combination with Libtayo) in perioperative NSCLC (first half 2024) | |||||||||||||
- | Initiate dose-expansion cohorts of REGN7075 (EGFR and CD28 costimulatory bispecific antibody) in combination with Libtayo in EGFR-high tumors (first half 2024) | |||||||||||||
- | Initiate cohorts combining REGN5678 (PSMA and CD28 costimulatory bispecific antibody) and REGN4336 (PSMA and CD3 bispecific antibody) in metastatic castration-resistant prostate cancer and initiate REGN5678 monotherapy cohort in renal cell carcinoma (first half 2024) | |||||||||||||
Hematology | - | FDA decision on BLA (target action date of March 31, 2024) and EC decision on regulatory submission (second half 2024) for odronextamab in relapsed/refractory FL and DLBCL | ||||||||||||
- | BLA acceptance for linvoseltamab in relapsed/refractory multiple myeloma (first quarter 2024) and FDA decision on BLA (second half 2024) | |||||||||||||
- | Initiate Phase 1 study of linvoseltamab in combination with CD38 and CD28 costimulatory bispecific antibody in multiple myeloma (2024) | |||||||||||||
- | Report Phase 2 results for REGN9933 (Factor XI antibody) in thrombosis (second half 2024) | |||||||||||||
Programs (continued) | Milestones | |||||||||||||
Genetic Medicines | - | Initiate Phase 1 study of Factor 9 gene insertion in hemophilia B (mid-2024) | ||||||||||||
- | Report additional data from Phase 1/2 study for DB-OTO (AAV-based gene therapy) in pediatrics with hearing loss (2024) | |||||||||||||
- | Initiate Phase 1 study of ALN-SOD (SOD1 siRNA) in amyotrophic lateral sclerosis (ALS) (2024) | |||||||||||||
Obesity | - | Initiate Phase 2 study of semaglutide in combination with trevogrumab (anti-myostatin) with and without garetosmab (anti-Activin A) (mid-2024) |
($ in millions) | Q4 2023 | Q4 2022 | % Change | FY 2023 | FY 2022 | % Change | ||||||||||||||||||||||||||||||||
Net product sales: | ||||||||||||||||||||||||||||||||||||||
EYLEA HD - U.S. | $ | 123 | $ | — | * | $ | 166 | $ | — | * | ||||||||||||||||||||||||||||
EYLEA - U.S. | 1,338 | 1,496 | (11 | %) | 5,720 | 6,265 | (9 | %) | ||||||||||||||||||||||||||||||
Total EYLEA HD and EYLEA - U.S. | 1,461 | 1,496 | (2 | %) | 5,886 | 6,265 | (6 | %) | ||||||||||||||||||||||||||||||
Libtayo - Global** | 244 | 152 | 61 | % | 863 | 448 | 93 | % | ||||||||||||||||||||||||||||||
Praluent® - U.S. | 61 | 36 | 69 | % | 182 | 130 | 40 | % | ||||||||||||||||||||||||||||||
Evkeeza - U.S. | 24 | 15 | 60 | % | 77 | 48 | 60 | % | ||||||||||||||||||||||||||||||
Inmazeb® - U.S. | 62 | — | * | 70 | 3 | * | ||||||||||||||||||||||||||||||||
Total net product sales | 1,852 | 1,699 | 9 | % | 7,078 | 6,894 | 3 | % | ||||||||||||||||||||||||||||||
Collaboration revenue: | ||||||||||||||||||||||||||||||||||||||
Sanofi | 993 | 836 | 19 | % | 3,800 | 2,856 | 33 | % | ||||||||||||||||||||||||||||||
Bayer | 377 | 355 | 6 | % | 1,487 | 1,431 | 4 | % | ||||||||||||||||||||||||||||||
Other | — | 396 | (100 | %) | 216 | 627 | (66 | %) | ||||||||||||||||||||||||||||||
Other revenue | 212 | 128 | 66 | % | 536 | 365 | 47 | % | ||||||||||||||||||||||||||||||
Total revenues | $ | 3,434 | $ | 3,414 | 1 | % | $ | 13,117 | $ | 12,173 | 8 | % | ||||||||||||||||||||||||||
* Percentage not meaningful | ||||||||||||||||||||||||||||||||||||||
** Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States. Excluded from the full year 2023 is approximately $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets (Sanofi recorded net product sales in such markets during a transition period). Similarly, excluded from the fourth quarter and full year 2022 is approximately $17 million and $34 million, respectively, of net product sales recorded by Sanofi (see Table 5). |
GAAP | % Change | Non-GAAP(a) | % Change | |||||||||||||||||||||||||||||||||||
($ in millions) | Q4 2023 | Q4 2022 | Q4 2023 | Q4 2022 | ||||||||||||||||||||||||||||||||||
Research and development (R&D) | $ | 1,177 | $ | 1,043 | 13 | % | $ | 1,031 | $ | 911 | 13 | % | ||||||||||||||||||||||||||
Acquired in-process research and development (IPR&D) | $ | 30 | $ | 30 | — | % | * | * | n/a | |||||||||||||||||||||||||||||
Selling, general, and administrative (SG&A) | $ | 738 | $ | 661 | 12 | % | $ | 622 | $ | 579 | 7 | % | ||||||||||||||||||||||||||
Cost of goods sold (COGS) | $ | 307 | $ | 302 | 2 | % | $ | 259 | $ | 126 | 106 | % | ||||||||||||||||||||||||||
Cost of collaboration and contract manufacturing (COCM) | $ | 210 | $ | 238 | (12 | %) | * | * | n/a | |||||||||||||||||||||||||||||
Other operating (income) expense, net | $ | (1) | $ | (7) | (86 | %) | * | * | n/a |
GAAP | % Change | Non-GAAP(a) | % Change | |||||||||||||||||||||||||||||||||||
FY 2023 | FY 2022 | FY 2023 | FY 2022 | |||||||||||||||||||||||||||||||||||
Research and development | $ | 4,439 | $ | 3,593 | 24 | % | $ | 3,919 | $ | 3,169 | 24 | % | ||||||||||||||||||||||||||
Acquired in-process research and development | $ | 186 | $ | 255 | (27 | %) | * | * | n/a | |||||||||||||||||||||||||||||
Selling, general, and administrative | $ | 2,631 | $ | 2,116 | 24 | % | $ | 2,232 | $ | 1,853 | 20 | % | ||||||||||||||||||||||||||
Cost of goods sold | $ | 932 | $ | 800 | 17 | % | $ | 770 | $ | 507 | 52 | % | ||||||||||||||||||||||||||
Cost of collaboration and contract manufacturing | $ | 884 | $ | 760 | 16 | % | * | * | n/a | |||||||||||||||||||||||||||||
Other operating (income) expense, net | $ | (2) | $ | (90) | (98 | %) | * | * | n/a | |||||||||||||||||||||||||||||
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded. |
2024 Guidance | ||||||||
GAAP R&D | $4.820–$5.070 billion | |||||||
Non-GAAP R&D(a) | $4.300–$4.500 billion | |||||||
GAAP SG&A | $2.890–$3.090 billion | |||||||
Non-GAAP SG&A(a) | $2.500–$2.650 billion | |||||||
GAAP gross margin on net product sales(d) | 86%–88% | |||||||
Non-GAAP gross margin on net product sales(a)(d) | 89%–91% | |||||||
COCM(e)* | $850–$910 million | |||||||
Capital expenditures* | $825–$950 million | |||||||
GAAP effective tax rate | 8%–10% | |||||||
Non-GAAP effective tax rate(a) | 10%–12% | |||||||
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded. |
Projected Range | ||||||||||||||
($ in millions) | Low | High | ||||||||||||
GAAP R&D | $ | 4,820 | $ | 5,070 | ||||||||||
Stock-based compensation expense | 510 | 540 | ||||||||||||
Acquisition and integration costs | 10 | 30 | ||||||||||||
Non-GAAP R&D | $ | 4,300 | $ | 4,500 | ||||||||||
GAAP SG&A | $ | 2,890 | $ | 3,090 | ||||||||||
Stock-based compensation expense | 350 | 380 | ||||||||||||
Acquisition and integration costs | 40 | 60 | ||||||||||||
Non-GAAP SG&A | $ | 2,500 | $ | 2,650 | ||||||||||
GAAP gross margin on net product sales | 86% | 88% | ||||||||||||
Stock-based compensation expense | 1% | 1% | ||||||||||||
Intangible asset amortization expense | 1% | 1% | ||||||||||||
Acquisition and integration costs | <1% | <1% | ||||||||||||
Non-GAAP gross margin on net product sales | 89% | 91% | ||||||||||||
GAAP ETR | 8% | 10% | ||||||||||||
Income tax effect of GAAP to non-GAAP reconciling items | 2% | 2% | ||||||||||||
Non-GAAP ETR | 10% | 12% |
(a) | This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, total revenues excluding Ronapreve, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company’s operations' ability to generate cash flows. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. | ||||
(b) | The casirivimab and imdevimab antibody cocktail for COVID-19 is known as REGEN-COV in the United States and Ronapreve in other countries. Roche records net product sales of Ronapreve outside the United States. | ||||
(c) | The Company's 2024 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. | ||||
(d) | Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. | ||||
(e) | Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues. | ||||
(f) | Represents Libtayo global net sales, inclusive of sales outside the United States which were recorded by Sanofi prior to July 1, 2022. |
Contact Information: | ||||||||
Ryan Crowe | Christina Chan | |||||||
Investor Relations | Corporate Affairs | |||||||
914-847-8790 | 914-847-8827 | |||||||
ryan.crowe@regeneron.com | christina.chan@regeneron.com |
December 31, | ||||||||||||||
2023 | 2022 | |||||||||||||
Assets: | ||||||||||||||
Cash and marketable securities | $ | 16,241.3 | $ | 14,334.1 | ||||||||||
Accounts receivable, net | 5,667.3 | 5,328.7 | ||||||||||||
Inventories | 2,580.5 | 2,401.9 | ||||||||||||
Property, plant, and equipment, net | 4,146.4 | 3,763.0 | ||||||||||||
Intangible assets, net | 1,038.6 | 915.5 | ||||||||||||
Deferred tax assets | 2,575.4 | 1,723.7 | ||||||||||||
Other assets | 830.7 | 747.6 | ||||||||||||
Total assets | $ | 33,080.2 | $ | 29,214.5 | ||||||||||
Liabilities and stockholders' equity: | ||||||||||||||
Accounts payable, accrued expenses, and other liabilities | $ | 3,818.6 | $ | 3,301.4 | ||||||||||
Finance lease liabilities | 720.0 | 720.0 | ||||||||||||
Deferred revenue | 585.6 | 547.7 | ||||||||||||
Long-term debt | 1,982.9 | 1,981.4 | ||||||||||||
Stockholders' equity | 25,973.1 | 22,664.0 | ||||||||||||
Total liabilities and stockholders' equity | $ | 33,080.2 | $ | 29,214.5 |
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||
Net product sales | $ | 1,851.8 | $ | 1,699.3 | $ | 7,078.0 | $ | 6,893.7 | ||||||||||||||||||
Collaboration revenue | 1,370.0 | 1,587.4 | 5,503.1 | 4,914.1 | ||||||||||||||||||||||
Other revenue | 212.5 | 127.7 | 536.1 | 365.1 | ||||||||||||||||||||||
3,434.3 | 3,414.4 | 13,117.2 | 12,172.9 | |||||||||||||||||||||||
Expenses: | ||||||||||||||||||||||||||
Research and development | 1,177.2 | 1,043.1 | 4,439.0 | 3,592.5 | ||||||||||||||||||||||
Acquired in-process research and development | 30.0 | 30.0 | 186.1 | 255.1 | ||||||||||||||||||||||
Selling, general, and administrative | 737.7 | 660.5 | 2,631.3 | 2,115.9 | ||||||||||||||||||||||
Cost of goods sold | 306.8 | 302.2 | 932.1 | 800.0 | ||||||||||||||||||||||
Cost of collaboration and contract manufacturing | 210.2 | 238.4 | 883.7 | 760.4 | ||||||||||||||||||||||
Other operating (income) expense, net | (0.5) | (6.6) | (2.1) | (89.9) | ||||||||||||||||||||||
2,461.4 | 2,267.6 | 9,070.1 | 7,434.0 | |||||||||||||||||||||||
Income from operations | 972.9 | 1,146.8 | 4,047.1 | 4,738.9 | ||||||||||||||||||||||
Other income (expense): | ||||||||||||||||||||||||||
Other income (expense), net | 193.0 | 195.3 | 225.2 | 179.3 | ||||||||||||||||||||||
Interest expense | (18.3) | (17.4) | (73.0) | (59.4) | ||||||||||||||||||||||
174.7 | 177.9 | 152.2 | 119.9 | |||||||||||||||||||||||
Income before income taxes | 1,147.6 | 1,324.7 | 4,199.3 | 4,858.8 | ||||||||||||||||||||||
Income tax (benefit) expense | (12.0) | 127.6 | 245.7 | 520.4 | ||||||||||||||||||||||
Net income | $ | 1,159.6 | $ | 1,197.1 | $ | 3,953.6 | $ | 4,338.4 | ||||||||||||||||||
Net income per share - basic | $ | 10.88 | $ | 11.19 | $ | 37.05 | $ | 40.51 | ||||||||||||||||||
Net income per share - diluted | $ | 10.19 | $ | 10.50 | $ | 34.77 | $ | 38.22 | ||||||||||||||||||
Weighted average shares outstanding - basic | 106.6 | 107.0 | 106.7 | 107.1 | ||||||||||||||||||||||
Weighted average shares outstanding - diluted | 113.8 | 114.0 | 113.7 | 113.5 |
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
GAAP R&D | $ | 1,177.2 | $ | 1,043.1 | $ | 4,439.0 | $ | 3,592.5 | ||||||||||||||||||
Stock-based compensation expense | 132.7 | 131.0 | 488.7 | 406.8 | ||||||||||||||||||||||
Acquisition and integration costs | 13.6 | 1.4 | 31.3 | 17.0 | ||||||||||||||||||||||
Non-GAAP R&D | $ | 1,030.9 | $ | 910.7 | $ | 3,919.0 | $ | 3,168.7 | ||||||||||||||||||
GAAP SG&A | $ | 737.7 | $ | 660.5 | $ | 2,631.3 | $ | 2,115.9 | ||||||||||||||||||
Stock-based compensation expense | 82.6 | 78.4 | 307.1 | 256.4 | ||||||||||||||||||||||
Acquisition and integration costs | 33.3 | 3.5 | 91.8 | 6.6 | ||||||||||||||||||||||
Non-GAAP SG&A | $ | 621.8 | $ | 578.6 | $ | 2,232.4 | $ | 1,852.9 | ||||||||||||||||||
GAAP COGS | $ | 306.8 | $ | 302.2 | $ | 932.1 | $ | 800.0 | ||||||||||||||||||
Stock-based compensation expense | 25.1 | 22.6 | 89.2 | 61.8 | ||||||||||||||||||||||
Acquisition and integration costs | 0.9 | — | 2.3 | — | ||||||||||||||||||||||
Intangible asset amortization expense | 21.9 | 19.7 | 80.9 | 34.8 | ||||||||||||||||||||||
Charges related to REGEN-COV | — | 133.7 | (10.0) | 196.6 | ||||||||||||||||||||||
Non-GAAP COGS | $ | 258.9 | $ | 126.2 | $ | 769.7 | $ | 506.8 | ||||||||||||||||||
GAAP other income (expense), net | $ | 174.7 | $ | 177.9 | $ | 152.2 | $ | 119.9 | ||||||||||||||||||
(Gains) losses on investments, net | (58.1) | (80.5) | 266.4 | 36.8 | ||||||||||||||||||||||
Non-GAAP other income (expense), net | $ | 116.6 | $ | 97.4 | $ | 418.6 | $ | 156.7 | ||||||||||||||||||
GAAP net income | $ | 1,159.6 | $ | 1,197.1 | $ | 3,953.6 | $ | 4,338.4 | ||||||||||||||||||
Total of GAAP to non-GAAP reconciling items above | 252.0 | 309.8 | 1,347.7 | 1,016.8 | ||||||||||||||||||||||
Income tax effect of GAAP to non-GAAP reconciling items | (45.3) | (57.9) | (256.8) | (191.3) | ||||||||||||||||||||||
Non-GAAP net income | $ | 1,366.3 | $ | 1,449.0 | $ | 5,044.5 | $ | 5,163.9 | ||||||||||||||||||
Non-GAAP net income per share - basic | $ | 12.82 | $ | 13.54 | $ | 47.28 | $ | 48.22 | ||||||||||||||||||
Non-GAAP net income per share - diluted | $ | 11.86 | $ | 12.56 | $ | 43.79 | $ | 44.98 | ||||||||||||||||||
Shares used in calculating: | ||||||||||||||||||||||||||
Non-GAAP net income per share - basic | 106.6 | 107.0 | 106.7 | 107.1 | ||||||||||||||||||||||
Non-GAAP net income per share - diluted | 115.2 | 115.4 | 115.2 | 114.8 |
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
Revenue reconciliation: | ||||||||||||||||||||||||||
Total revenues | $ | 3,434.3 | $ | 3,414.4 | $ | 13,117.2 | $ | 12,172.9 | ||||||||||||||||||
Global gross profit payment from Roche in connection with sales of Ronapreve | 2.1 | 396.4 | 224.3 | 627.3 | ||||||||||||||||||||||
Other | (3.8) | — | (13.3) | — | ||||||||||||||||||||||
Total revenues excluding Ronapreve | $ | 3,436.0 | $ | 3,018.0 | $ | 12,906.2 | $ | 11,545.6 | ||||||||||||||||||
Effective tax rate reconciliation: | ||||||||||||||||||||||||||
GAAP ETR | (1.0%) | 9.6% | 5.9% | 10.7% | ||||||||||||||||||||||
Income tax effect of GAAP to non-GAAP reconciling items | 3.4% | 1.7% | 3.2% | 1.4% | ||||||||||||||||||||||
Non-GAAP ETR | 2.4% | 11.3% | 9.1% | 12.1% | ||||||||||||||||||||||
Year Ended December 31, | ||||||||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||||
Free cash flow reconciliation: | ||||||||||||||||||||||||||
Net cash provided by operating activities | $ | 4,594.0 | $ | 5,014.9 | ||||||||||||||||||||||
Capital expenditures | (718.6) | (590.1) | ||||||||||||||||||||||||
Free cash flow | $ | 3,875.4 | $ | 4,424.8 |
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
Sanofi collaboration revenue: | ||||||||||||||||||||||||||
Antibody: | ||||||||||||||||||||||||||
Regeneron's share of profits in connection with commercialization of antibodies | $ | 885.9 | $ | 619.0 | $ | 3,136.5 | $ | 2,082.0 | ||||||||||||||||||
Sales-based milestones earned | — | 50.0 | 50.0 | 100.0 | ||||||||||||||||||||||
Reimbursement for manufacturing of commercial supplies | 107.0 | 166.9 | 613.0 | 633.7 | ||||||||||||||||||||||
Other | — | — | — | 28.7 | ||||||||||||||||||||||
Immuno-oncology | — | — | — | 11.3 | ||||||||||||||||||||||
Total Sanofi collaboration revenue | 992.9 | 835.9 | 3,799.5 | 2,855.7 | ||||||||||||||||||||||
Bayer collaboration revenue: | ||||||||||||||||||||||||||
Regeneron's share of profits in connection with commercialization of EYLEA outside the United States | 345.4 | 324.0 | 1,376.4 | 1,317.4 | ||||||||||||||||||||||
Reimbursement for manufacturing of ex-U.S. commercial supplies | 31.4 | 31.1 | 111.1 | 91.4 | ||||||||||||||||||||||
One-time payment in connection with change in Japan arrangement | — | — | — | 21.9 | ||||||||||||||||||||||
Total Bayer collaboration revenue | 376.8 | 355.1 | 1,487.5 | 1,430.7 | ||||||||||||||||||||||
Other collaboration revenue: | ||||||||||||||||||||||||||
Global gross profit payment from Roche in connection with sales of Ronapreve | 2.1 | 396.4 | 224.3 | 627.3 | ||||||||||||||||||||||
Other | (1.8) | — | (8.2) | 0.4 | ||||||||||||||||||||||
Total collaboration revenue | $ | 1,370.0 | $ | 1,587.4 | $ | 5,503.1 | $ | 4,914.1 |
Three Months Ended December 31, | ||||||||||||||||||||||||||||||||||||||||||||
2023 | 2022 | % Change | ||||||||||||||||||||||||||||||||||||||||||
U.S. | ROW(g) | Total | U.S. | ROW | Total | (Total Sales) | ||||||||||||||||||||||||||||||||||||||
EYLEA HD(a) | $ | 123.1 | $ | — | $ | 123.1 | $ | — | $ | — | $ | — | * | |||||||||||||||||||||||||||||||
EYLEA(a) | $ | 1,337.5 | $ | 889.6 | $ | 2,227.1 | $ | 1,496.4 | $ | 838.6 | $ | 2,335.0 | (5 | %) | ||||||||||||||||||||||||||||||
Total EYLEA HD and EYLEA | $ | 1,460.6 | $ | 889.6 | $ | 2,350.2 | $ | 1,496.4 | $ | 838.6 | $ | 2,335.0 | 1 | % | ||||||||||||||||||||||||||||||
Dupixent(b) | $ | 2,486.0 | $ | 730.1 | $ | 3,216.1 | $ | 1,936.3 | $ | 512.6 | $ | 2,448.9 | 31 | % | ||||||||||||||||||||||||||||||
Libtayo(c) | $ | 154.8 | $ | 89.0 | $ | 243.8 | $ | 110.0 | $ | 58.8 | $ | 168.8 | 44 | % | ||||||||||||||||||||||||||||||
Praluent(d) | $ | 61.3 | $ | 125.9 | $ | 187.2 | $ | 35.5 | $ | 97.9 | $ | 133.4 | 40 | % | ||||||||||||||||||||||||||||||
REGEN-COV(e) | $ | — | $ | 5.6 | $ | 5.6 | $ | — | $ | 1,088.4 | $ | 1,088.4 | (99 | %) | ||||||||||||||||||||||||||||||
Kevzara(b) | $ | 66.2 | $ | 46.0 | $ | 112.2 | $ | 46.6 | $ | 34.6 | $ | 81.2 | 38 | % | ||||||||||||||||||||||||||||||
Other products(f) | $ | 86.5 | $ | 18.5 | $ | 105.0 | $ | 16.6 | $ | 15.0 | $ | 31.6 | 232 | % | ||||||||||||||||||||||||||||||
Year Ended December 31, | ||||||||||||||||||||||||||||||||||||||||||||
2023 | 2022 | % Change | ||||||||||||||||||||||||||||||||||||||||||
U.S. | ROW | Total | U.S. | ROW | Total | (Total Sales) | ||||||||||||||||||||||||||||||||||||||
EYLEA HD(a) | $ | 165.8 | $ | — | $ | 165.8 | $ | — | $ | — | $ | — | * | |||||||||||||||||||||||||||||||
EYLEA(a) | $ | 5,719.6 | $ | 3,495.2 | $ | 9,214.8 | $ | 6,264.6 | $ | 3,382.8 | $ | 9,647.4 | (4 | %) | ||||||||||||||||||||||||||||||
Total EYLEA HD and EYLEA | $ | 5,885.4 | $ | 3,495.2 | $ | 9,380.6 | $ | 6,264.6 | $ | 3,382.8 | $ | 9,647.4 | (3 | %) | ||||||||||||||||||||||||||||||
Dupixent(b) | $ | 8,855.6 | $ | 2,732.5 | $ | 11,588.1 | $ | 6,668.0 | $ | 2,013.2 | $ | 8,681.2 | 33 | % | ||||||||||||||||||||||||||||||
Libtayo(c) | $ | 538.8 | $ | 330.0 | $ | 868.8 | $ | 374.5 | $ | 203.5 | $ | 578.0 | 50 | % | ||||||||||||||||||||||||||||||
Praluent(d) | $ | 182.4 | $ | 456.5 | $ | 638.9 | $ | 130.0 | $ | 337.4 | $ | 467.4 | 37 | % | ||||||||||||||||||||||||||||||
REGEN-COV(e) | $ | — | $ | 618.8 | $ | 618.8 | $ | — | $ | 1,769.6 | $ | 1,769.6 | (65 | %) | ||||||||||||||||||||||||||||||
Kevzara(b) | $ | 214.7 | $ | 171.2 | $ | 385.9 | $ | 199.7 | $ | 158.3 | $ | 358.0 | 8 | % | ||||||||||||||||||||||||||||||
Other products(f) | $ | 150.5 | $ | 67.4 | $ | 217.9 | $ | 56.1 | $ | 69.1 | $ | 125.2 | 74 | % | ||||||||||||||||||||||||||||||
* Percentage not meaningful | ||||||||||||||||||||||||||||||||||||||||||||
(a) Regeneron records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States. | ||||||||||||||||||||||||||||||||||||||||||||
(b) Sanofi records global net product sales of Dupixent and Kevzara. The Company records its share of profits in connection with global sales of Dupixent and Kevzara. | ||||||||||||||||||||||||||||||||||||||||||||
(c) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. The parties equally shared profits/losses in connection with global sales of Libtayo. Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States and pays Sanofi a royalty on global sales. Included in this line item for the years ended December 31, 2023 and 2022 is approximately $6 million and $34 million, respectively, and for the fourth quarter of 2022 approximately $17 million, of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 had been sold through to the end customers). | ||||||||||||||||||||||||||||||||||||||||||||
(d) Regeneron records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales. | ||||||||||||||||||||||||||||||||||||||||||||
(e) Roche records net product sales outside the United States; the parties share gross profits from sales based on a pre-specified formula. | ||||||||||||||||||||||||||||||||||||||||||||
(f) Included in this line item are products which are sold by the Company and others. Refer to "Fourth Quarter 2023 Financial Results" section above for a complete listing of net product sales recorded by the Company. | ||||||||||||||||||||||||||||||||||||||||||||
(g) Rest of world (ROW) |
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Cover |
Feb. 02, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Entity Registrant Name | REGENERON PHARMACEUTICALS, INC. |
Document Period End Date | Feb. 02, 2024 |
Entity Incorporation, State or Country Code | NY |
Entity File Number | 000-19034 |
Entity Tax Identification Number | 13-3444607 |
Entity Address, Address Line One | 777 Old Saw Mill River Road |
Entity Address, City or Town | Tarrytown |
Entity Address, State or Province | NY |
Entity Address, Postal Zip Code | 10591-6707 |
City Area Code | 914 |
Local Phone Number | 847-7000 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock - par value $.001 per share |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Trading Symbol | REGN |
Cover |
Feb. 02, 2024 |
---|---|
Cover [Abstract] | |
Entity Central Index Key | 0000872589 |
Amendment Flag | false |
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