Regeneron Reports Second Quarter 2025 Financial and Operating Results
- Second quarter 2025 revenues increased 4% to
$3.68 billion versus second quarter 2024 - Dupixent® global net sales (recorded by Sanofi) increased 22% to
$4.34 billion - EYLEA HD®
U.S. net sales increased 29% to $393 million; total EYLEA HD and EYLEA®U.S. net sales decreased 25% to$1.15 billion - GAAP EPS increased 3% to
$12.81 ; non-GAAP EPS(a) increased 12% to$12.89 - FDA approved Lynozyfic™ (linvoseltamab) for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria (CSU)
- FDA accepted for priority review Libtayo® sBLA for adjuvant cutaneous squamous cell carcinoma (CSCC)
- In-licensed rights to late-stage dual GLP-1/GIP receptor agonist; reported interim 26-week data from Phase 2 COURAGE trial in obesity
"
Financial Highlights
| ($ in millions, except per share data) | Q2 2025 | Q2 2024 | % Change | |||||||||
| Total revenues | $ | 3,676 | $ | 3,547 | 4 | % | ||||||
| GAAP net income | $ | 1,392 | $ | 1,432 | (3 | %) | ||||||
| GAAP net income per share - diluted | $ | 12.81 | $ | 12.41 | 3 | % | ||||||
| Non-GAAP net income(a) | $ | 1,424 | $ | 1,351 | 5 | % | ||||||
| Non-GAAP net income per share - diluted(a) | $ | 12.89 | $ | 11.56 | 12 | % | ||||||
"We are pleased with our second quarter financial performance, which reflects strong momentum across our business, highlighted by 4% revenue growth and 12% non-GAAP earnings growth," said
Business Highlights
Key Pipeline Progress
Dupixent (dupilumab)
- In
June 2025 , the FDA approved Dupixent for the treatment of adults with bullous pemphigoid. Regulatory applications are under review in theEuropean Union (EU) andJapan . - In
April 2025 , the FDA approved Dupixent for the treatment of adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment. Regulatory applications were submitted to the FDA and in the EU for CSU in children aged 2 to 11 years.
EYLEA HD (aflibercept) 8 mg
- The
European Commission (EC) approved EYLEA 8 mg with extended dosing intervals of up to 6 months (24 weeks) for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). - The Company now expects regulatory approvals to be delayed for its currently pending FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have PDUFA dates in
August 2025 . The anticipated delay is related to observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications,Catalent Indiana LLC (recently acquired by Novo Nordisk A/S). This inspection was completed in mid-July and was not specific to EYLEA HD. Novo has been in communication with the FDA and expects to submit its response next week. Based on the Company's review of the observations and Novo's proposed response to the FDA, along with the progress the Company has made with alternate third-party fillers, the Company anticipates an expeditious resolution of the filling issues for EYLEA HD.
Oncology Programs
- In
July 2025 , the FDA granted accelerated approval for Lynozyfic (linvoseltamab) to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Additionally, the EC granted conditional marketing approval of Lynozyfic to treat adults with relapsed or refractory multiple myeloma who have received at least three prior therapies. - In
July 2025 , Lynozyfic was added to the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of multiple myeloma. - The FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab) in adjuvant CSCC, with a target action date in
October 2025 . - The Company announced detailed analyses from a Phase 3 trial of Libtayo in adjuvant CSCC. The results, presented at the 2025
American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in theNew England Journal of Medicine , included additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes. - On
July 30, 2025 , the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by theCatalent Indiana LLC site inspection (as described above).
Other Programs
- The Company announced interim 26-week results from the ongoing Phase 2 COURAGE trial investigating combinations of semaglutide and trevogrumab (myostatin antibody) with or without garetosmab (Activin A antibody) for the treatment of obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab preserved lean mass while increasing loss of fat mass. Final 26-week efficacy and safety results were consistent with the interim data and will be presented at the 61st Annual Meeting of the
European Association for the Study of Diabetes (EASD) inSeptember 2025 . - A Phase 3 study for REGN7508, an antibody to Factor XI (catalytic domain), was initiated to evaluate the prevention of venous thromboembolism after total knee replacement surgery. Initiation of additional Phase 3 studies is planned for later this year and the first half of 2026.
- The Company and Sanofi announced that a Phase 3 trial, AERIFY-1, for itepekimab, an antibody to IL-33, in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The Company and Sanofi continue to evaluate the data to inform next steps for potential future COPD development.
Corporate and Business Development Updates
- In
July 2025 , the Company's license agreement withHansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainlandChina ,Hong Kong , andMacau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development inChina ) became effective. In-licensing a late-stage GLP1/GIP agonist enables the Company to study combinations with its products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. - A jury verdict in the
U.S. District Court for the District of Delaware found that Amgen Inc. violated antitrust and tort laws by creating an anticompetitive bundling scheme which was designed to exclude Praluent from the market. - In
June 2025 , the Company announced the launch of a matching program for donations to Good Days, an independent national non-profit charitable organization, to support theirRetinal Vascular and Neovascular Disease Fund . The Company has committed to matching donations up to a total of$200 million at a one-to-one rate through the end of 2025, with the goal of enabling more patients to affordably access essential medicines that help protect their vision. - The Company acquired an FDA Rare Pediatric Disease Priority Review Voucher from a third party for
$155 million .
Second Quarter 2025 Financial Results
Revenues
| ($ in millions) | Q2 2025 | Q2 2024 | % Change | |||||||||
| Net product sales: | ||||||||||||
| EYLEA HD - |
$ | 393 | $ | 304 | 29 | % | ||||||
| EYLEA - |
754 | 1,231 | (39 | %) | ||||||||
| Total EYLEA HD and EYLEA - |
1,147 | 1,535 | (25 | %) | ||||||||
| Libtayo - |
248 | 182 | 36 | % | ||||||||
| Libtayo - ROW* | 129 | 115 | 12 | % | ||||||||
| Total Libtayo - Global | 377 | 297 | 27 | % | ||||||||
| Praluent® - |
66 | 56 | 18 | % | ||||||||
| Evkeeza® - |
41 | 31 | 32 | % | ||||||||
| Total net product sales | 1,631 | 1,919 | (15 | %) | ||||||||
| Collaboration revenue: | ||||||||||||
| Sanofi | 1,444 | 1,146 | 26 | % | ||||||||
| Bayer | 415 | 375 | 11 | % | ||||||||
| Other | 2 | 3 | (33 | %) | ||||||||
| Other revenue | 184 | 104 | 77 | % | ||||||||
| Total revenues | $ | 3,676 | $ | 3,547 | 4 | % | ||||||
| * Rest of world (ROW) | ||||||||||||
Net product sales of EYLEA HD increased in the second quarter of 2025, compared to the second quarter of 2024, due to higher sales volumes driven by increased demand.
Net product sales of EYLEA in the second quarter of 2025, compared to the second quarter of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, 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.
Sanofi collaboration revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in the Company's share of profits from the commercialization of antibodies, which were
Refer to Table 4 for a summary of collaboration revenue.
Other revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $118 million and $69 million for the second quarter of 2025 and 2024, respectively.
Operating Expenses
| GAAP | % Change |
Non-GAAP(a) | % Change |
|||||||||||||||||||||
| ($ in millions) | Q2 2025 | Q2 2024 | Q2 2025 | Q2 2024 | ||||||||||||||||||||
| Research and development (R&D) | $ | 1,422 | $ | 1,200 | 19% | $ | 1,283 | $ | 1,072 | 20% | ||||||||||||||
| Acquired in-process research and | ||||||||||||||||||||||||
| development (IPR&D) | $ | 10 | $ | 24 | (58%) | * | * | n/a | ||||||||||||||||
| Selling, general, and administrative | ||||||||||||||||||||||||
| (SG&A) | $ | 634 | $ | 759 | (16%) | $ | 542 | $ | 667 | (19%) | ||||||||||||||
| Cost of goods sold (COGS) | $ | 276 | $ | 258 | 7% | $ | 222 | $ | 214 | 4% | ||||||||||||||
| Gross margin on net product sales(c) | 83% | 87% | 86% | 89% | ||||||||||||||||||||
| Cost of collaboration and contract | ||||||||||||||||||||||||
| manufacturing (COCM)(d) | $ | 255 | $ | 222 | 15% | * | * | n/a | ||||||||||||||||
| Other 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 second quarter of 2025, compared to the second quarter of 2024, driven by the advancement of the Company's mid- and late-stage clinical pipeline.
- GAAP and non-GAAP SG&A expenses decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.
- GAAP and non-GAAP gross margin on net product sales decreased in the second quarter of 2025, compared to the second quarter of 2024, partly due to ongoing investments to support the Company's manufacturing operations and higher inventory write-offs and reserves in the second quarter of 2025 compared to the second quarter of 2024.
Other Financial Information
GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of
In the second quarter of 2025, the Company's GAAP effective tax rate (ETR) was 8.4%, compared to 12.0% in the second quarter of 2024. The GAAP ETR decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to the net change in uncertain tax positions, partly offset by lower tax benefits from less stock option exercises. During the second quarter of 2025, the release of liabilities for uncertain tax positions recognized upon the effective settlement of an
A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
Capital Allocation
During the second quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or
In
2025 Financial Guidance(b)
The Company's full year 2025 financial guidance consists of the following components:
| 2025 Guidance | ||||
| Prior | Updated | |||
| GAAP R&D | ||||
| Non-GAAP R&D(a) | ||||
| GAAP SG&A | ||||
| Non-GAAP SG&A(a) | ||||
| GAAP gross margin on net product sales | 83%–84% | Approximately 83% | ||
| Non-GAAP gross margin on net product sales(a) | 86%–87% | Approximately 86% | ||
| COCM* | ||||
| Capital expenditures* | $850–$950 million | $880–$950 million | ||
| GAAP effective tax rate | 9%–11% | 11%–13% | ||
| Non-GAAP effective tax rate(a) | 11%–13% | Unchanged | ||
| * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded | ||||
A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below:
| ($ in millions) | Low | High | ||||||
| GAAP R&D | $ | 5,660 | $ | 5,790 | ||||
| Stock-based compensation expense | 560 | 590 | ||||||
| Non-GAAP R&D | $ | 5,100 | $ | 5,200 | ||||
| GAAP SG&A | $ | 2,810 | $ | 2,940 | ||||
| Stock-based compensation expense | 360 | 390 | ||||||
| Non-GAAP SG&A | $ | 2,450 | $ | 2,550 | ||||
| GAAP gross margin on net product sales | 83% | 83% | ||||||
| Intangible asset amortization expense | 2% | 2% | ||||||
| Stock-based compensation expense | 1% | 1% | ||||||
| Non-GAAP gross margin on net product sales | 86% | 86% | ||||||
| GAAP ETR | 11% | 13% | ||||||
| Income tax effect of GAAP to non-GAAP | ||||||||
| reconciling items | <1% | <1% | ||||||
| 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 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
About
For more information, please visit www.regeneron.com or follow
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
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
| Contact Information: | ||
| Investor Relations | Corporate Affairs | |
| 914-847-8790 | 914-847-8827 | |
| ryan.crowe@regeneron.com | christina.chan@regeneron.com | |
TABLE 1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In millions) |
||||||||
| 2025 | 2024 | |||||||
| Assets: | ||||||||
| Cash and marketable securities | $ | 17,527.8 | $ | 17,912.6 | ||||
| Accounts receivable, net | 5,610.0 | 6,211.9 | ||||||
| Inventories | 3,205.6 | 3,087.3 | ||||||
| Property, plant, and equipment, net | 4,840.7 | 4,599.7 | ||||||
| Intangible assets, net | 1,351.7 | 1,148.6 | ||||||
| Deferred tax assets | 3,572.2 | 3,314.1 | ||||||
| Other assets | 2,111.2 | 1,485.2 | ||||||
| Total assets | $ | 38,219.2 | $ | 37,759.4 | ||||
| Liabilities and stockholders' equity: | ||||||||
| Accounts payable, accrued expenses, and other liabilities | $ | 4,887.0 | $ | 4,888.0 | ||||
| Finance lease liabilities | 720.0 | 720.0 | ||||||
| Deferred revenue | 688.2 | 813.4 | ||||||
| Long-term debt | 1,985.1 | 1,984.4 | ||||||
| Stockholders' equity | 29,938.9 | 29,353.6 | ||||||
| Total liabilities and stockholders' equity | $ | 38,219.2 | $ | 37,759.4 | ||||
TABLE 2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In millions, except per share data) |
||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product sales | $ | 1,631.0 | $ | 1,918.6 | $ | 3,046.6 | $ | 3,679.9 | ||||||||
| Collaboration revenue | 1,860.7 | 1,524.0 | 3,391.9 | 2,790.8 | ||||||||||||
| Other revenue | 183.9 | 104.5 | 265.8 | 221.4 | ||||||||||||
| 3,675.6 | 3,547.1 | 6,704.3 | 6,692.1 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | 1,421.7 | 1,200.0 | 2,749.1 | 2,448.4 | ||||||||||||
| Acquired in-process research and development | 10.0 | 23.9 | 22.3 | 31.0 | ||||||||||||
| Selling, general, and administrative | 634.2 | 758.8 | 1,267.2 | 1,447.8 | ||||||||||||
| Cost of goods sold | 275.6 | 257.8 | 541.1 | 498.2 | ||||||||||||
| Cost of collaboration and contract manufacturing | 254.6 | 222.4 | 453.4 | 415.8 | ||||||||||||
| Other operating expense (income), net | — | 14.6 | — | 29.9 | ||||||||||||
| 2,596.1 | 2,477.5 | 5,033.1 | 4,871.1 | |||||||||||||
| Income from operations | 1,079.5 | 1,069.6 | 1,671.2 | 1,821.0 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Other income (expense), net | 442.8 | 573.3 | 764.8 | 538.7 | ||||||||||||
| Interest expense | (3.6 | ) | (14.8 | ) | (12.3 | ) | (30.9 | ) | ||||||||
| 439.2 | 558.5 | 752.5 | 507.8 | |||||||||||||
| Income before income taxes | 1,518.7 | 1,628.1 | 2,423.7 | 2,328.8 | ||||||||||||
| Income tax expense | 127.1 | 195.8 | 223.4 | 174.5 | ||||||||||||
| Net income | $ | 1,391.6 | $ | 1,432.3 | $ | 2,200.3 | $ | 2,154.3 | ||||||||
| Net income per share - basic | $ | 13.24 | $ | 13.25 | $ | 20.78 | $ | 19.95 | ||||||||
| Net income per share - diluted | $ | 12.81 | $ | 12.41 | $ | 20.02 | $ | 18.68 | ||||||||
| Weighted average shares outstanding - basic | 105.1 | 108.1 | 105.9 | 108.0 | ||||||||||||
| Weighted average shares outstanding - diluted | 108.6 | 115.4 | 109.9 | 115.3 | ||||||||||||
TABLE 3
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (In millions, except per share data) |
||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| GAAP R&D | $ | 1,421.7 | $ | 1,200.0 | $ | 2,749.1 | $ | 2,448.4 | ||||||||
| Stock-based compensation expense | 139.0 | 122.4 | 280.0 | 245.4 | ||||||||||||
| Acquisition and integration costs | — | 5.3 | — | 9.1 | ||||||||||||
| Non-GAAP R&D | $ | 1,282.7 | $ | 1,072.3 | $ | 2,469.1 | $ | 2,193.9 | ||||||||
| GAAP SG&A | $ | 634.2 | $ | 758.8 | $ | 1,267.2 | $ | 1,447.8 | ||||||||
| Stock-based compensation expense | 91.8 | 82.6 | 187.0 | 168.8 | ||||||||||||
| Acquisition and integration costs | — | 9.7 | 0.8 | 28.5 | ||||||||||||
| Non-GAAP SG&A | $ | 542.4 | $ | 666.5 | $ | 1,079.4 | $ | 1,250.5 | ||||||||
| GAAP COGS | $ | 275.6 | $ | 257.8 | $ | 541.1 | $ | 498.2 | ||||||||
| Stock-based compensation expense | 20.9 | 18.2 | 40.4 | 39.1 | ||||||||||||
| Acquisition and integration costs | — | 0.8 | — | 1.2 | ||||||||||||
| Intangible asset amortization expense | 32.4 | 25.1 | 61.1 | 48.3 | ||||||||||||
| Non-GAAP COGS | $ | 222.3 | $ | 213.7 | $ | 439.6 | $ | 409.6 | ||||||||
| GAAP other operating expense (income), net | $ | — | $ | 14.6 | $ | — | $ | 29.9 | ||||||||
| Change in fair value of contingent consideration | — | 14.6 | — | 29.9 | ||||||||||||
| Non-GAAP other operating expense (income), net | $ | — | $ | — | $ | — | $ | — | ||||||||
| GAAP other income (expense), net | $ | 439.2 | $ | 558.5 | $ | 752.5 | $ | 507.8 | ||||||||
| Gains on investments, net | (250.0 | ) | (392.6 | ) | (389.9 | ) | (196.5 | ) | ||||||||
| Non-GAAP other income (expense), net | $ | 189.2 | $ | 165.9 | $ | 362.6 | $ | 311.3 | ||||||||
| GAAP net income | $ | 1,391.6 | $ | 1,432.3 | $ | 2,200.3 | $ | 2,154.3 | ||||||||
| Total of GAAP to non-GAAP reconciling items above | 34.1 | (113.9 | ) | 179.4 | 373.8 | |||||||||||
| Income tax effect of GAAP to non-GAAP reconciling items | (2.1 | ) | 32.8 | (27.7 | ) | (61.0 | ) | |||||||||
| Non-GAAP net income | $ | 1,423.6 | $ | 1,351.2 | $ | 2,352.0 | $ | 2,467.1 | ||||||||
| Non-GAAP net income per share - basic | $ | 13.55 | $ | 12.50 | $ | 22.21 | $ | 22.84 | ||||||||
| Non-GAAP net income per share - diluted | $ | 12.89 | $ | 11.56 | $ | 21.06 | $ | 21.09 | ||||||||
| Shares used in calculating: | ||||||||||||||||
| Non-GAAP net income per share - basic | 105.1 | 108.1 | 105.9 | 108.0 | ||||||||||||
| Non-GAAP net income per share - diluted | 110.4 | 116.9 | 111.7 | 117.0 | ||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) | |||||||||||||||
| Three Months Ended |
Six Months Ended |
||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Effective tax rate reconciliation: | |||||||||||||||
| GAAP ETR | 8.4 | % | 12.0 | % | 9.2 | % | 7.5 | % | |||||||
| Income tax effect of GAAP to non-GAAP reconciling items | (0.1 | %) | (1.2 | %) | 0.4 | % | 1.2 | % | |||||||
| Non-GAAP ETR | 8.3 | % | 10.8 | % | 9.6 | % | 8.7 | % | |||||||
| Gross margin on net product sales reconciliation: | |||||||||||||||
| GAAP gross margin on net product sales | 83 | % | 87 | % | 82 | % | 86 | % | |||||||
| Intangible asset amortization expense | 2 | % | 1 | % | 2 | % | 2 | % | |||||||
| Stock-based compensation expense | 1 | % | 1 | % | 2 | % | 1 | % | |||||||
| Non-GAAP gross margin on net product sales | 86 | % | 89 | % | 86 | % | 89 | % | |||||||
| Six Months Ended |
|||||||||||||||
| 2025 | 2024 | ||||||||||||||
| Free cash flow reconciliation: | |||||||||||||||
| Net cash provided by operating activities | $ | 2,189.5 | $ | 1,866.5 | |||||||||||
| Capital expenditures | (448.3 | ) | (314.4 | ) | |||||||||||
| Free cash flow | $ | 1,741.2 | $ | 1,552.1 | |||||||||||
TABLE 4
COLLABORATION REVENUE (Unaudited) (In millions) |
||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Sanofi collaboration revenue: | ||||||||||||||||
| commercialization of antibodies | $ | 1,282.1 | $ | 988.3 | $ | 2,300.2 | $ | 1,792.3 | ||||||||
| Reimbursement for manufacturing of commercial supplies | 161.5 | 157.3 | 326.6 | 263.1 | ||||||||||||
| Total Sanofi collaboration revenue | 1,443.6 | 1,145.6 | 2,626.8 | 2,055.4 | ||||||||||||
| Bayer collaboration revenue: | ||||||||||||||||
| commercialization of EYLEA 8 mg and EYLEA outside the |
||||||||||||||||
| 383.4 | 353.0 | 700.7 | 686.9 | |||||||||||||
| Reimbursement for manufacturing of commercial supplies | 31.6 | 22.1 | 58.2 | 44.2 | ||||||||||||
| Total Bayer collaboration revenue | 415.0 | 375.1 | 758.9 | 731.1 | ||||||||||||
| Other collaboration revenue | 2.1 | 3.3 | 6.2 | 4.3 | ||||||||||||
| Total collaboration revenue | $ | 1,860.7 | $ | 1,524.0 | $ | 3,391.9 | $ | 2,790.8 | ||||||||
TABLE 5
NET PRODUCT SALES OF (In millions) |
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| Three Months Ended |
||||||||||||||||||||||||||||
| 2025 | 2024 | % Change | ||||||||||||||||||||||||||
| ROW | Total | ROW | Total | (Total Sales) | ||||||||||||||||||||||||
| EYLEA HD(a) | $ | 393.2 | $ | 241.7 | $ | 634.9 | $ | 304.2 | $ | 59.1 | $ | 363.3 | 75 | % | ||||||||||||||
| EYLEA(a) | $ | 754.3 | $ | 736.0 | $ | 1,490.3 | $ | 1,230.5 | $ | 848.7 | $ | 2,079.2 | (28 | %) | ||||||||||||||
| Total EYLEA HD and EYLEA | $ | 1,147.5 | $ | 977.7 | $ | 2,125.2 | $ | 1,534.7 | $ | 907.8 | $ | 2,442.5 | (13 | %) | ||||||||||||||
| Dupixent(b) | $ | 3,205.0 | $ | 1,139.6 | $ | 4,344.6 | $ | 2,610.2 | $ | 946.2 | $ | 3,556.4 | 22 | % | ||||||||||||||
| Libtayo(c) | $ | 247.8 | $ | 128.7 | $ | 376.5 | $ | 182.4 | $ | 115.0 | $ | 297.4 | 27 | % | ||||||||||||||
| Praluent(d) | $ | 65.8 | $ | 156.2 | $ | 222.0 | $ | 56.1 | $ | 135.8 | $ | 191.9 | 16 | % | ||||||||||||||
| Kevzara(b) | $ | 95.7 | $ | 56.5 | $ | 152.2 | $ | 65.1 | $ | 44.6 | $ | 109.7 | 39 | % | ||||||||||||||
| Other products(e) | $ | 42.1 | $ | 30.0 | $ | 72.1 | $ | 30.9 | $ | 21.9 | $ | 52.8 | 37 | % | ||||||||||||||
| Six Months Ended |
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| 2025 | 2024 | % Change | ||||||||||||||||||||||||||
| ROW | Total | ROW | Total | (Total Sales) | ||||||||||||||||||||||||
| EYLEA HD(a) | $ | 700.0 | $ | 388.1 | $ | 1,088.1 | $ | 504.2 | $ | 74.3 | $ | 578.5 | 88 | % | ||||||||||||||
| EYLEA(a) | $ | 1,490.3 | $ | 1,447.4 | $ | 2,937.7 | $ | 2,432.1 | $ | 1,682.9 | $ | 4,115.0 | (29 | %) | ||||||||||||||
| Total EYLEA HD and EYLEA | $ | 2,190.3 | $ | 1,835.5 | $ | 4,025.8 | $ | 2,936.3 | $ | 1,757.2 | $ | 4,693.5 | (14 | %) | ||||||||||||||
| Dupixent(b) | $ | 5,834.4 | $ | 2,175.8 | $ | 8,010.2 | $ | 4,828.2 | $ | 1,805.0 | $ | 6,633.2 | 21 | % | ||||||||||||||
| Libtayo(c) | $ | 440.3 | $ | 221.3 | $ | 661.6 | $ | 341.6 | $ | 219.7 | $ | 561.3 | 18 | % | ||||||||||||||
| Praluent(d) | $ | 122.6 | $ | 292.7 | $ | 415.3 | $ | 126.1 | $ | 267.1 | $ | 393.2 | 6 | % | ||||||||||||||
| Kevzara(b) | $ | 168.5 | $ | 100.1 | $ | 268.6 | $ | 115.1 | $ | 88.7 | $ | 203.8 | 32 | % | ||||||||||||||
| Other products(e) | $ | 73.2 | $ | 53.5 | $ | 126.7 | $ | 56.2 | $ | 40.8 | $ | 97.0 | 31 | % | ||||||||||||||
| Note: The table above includes net product sales of |
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| (a) The Company records net product sales of EYLEA HD and EYLEA in |
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| (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 |
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| (e) Included in this line item are products which are sold by the Company and others. Refer to "Second 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. | ||||||||||||||||||||||||||||
Source: Regeneron Pharmaceuticals, Inc.