01—Abstract
Summary
Summary of the 10-K filed February 4, 2026. Cited figures are marked; the original filing is the authoritative source.
Regeneron's FY2025 10-K shows revenue of $14.34Ba (up about 1% from $14.20B in 2024) and net income of $4.50B, with diluted EPS of $41.48 versus $38.34.
Growth came from collaboration revenue, especially Sanofi (up 30% to $5.88Bb, driven by Dupixent), which offset a 17% decline in net product sales to $6.31B. Net product sales fell because U.S. EYLEA sales dropped 42% to $2.75B on biosimilar competition, compounded bevacizumab substitution, and patient migration to EYLEA HD. Operating income fell to $3.58B from $3.99B as R&D rose 14% to $5.85B, partly due to a $155M priority review voucher expense.
Net income was lifted by $1.65Bc in other income, mainly $946M of securities gains and $717M of interest income. Concentration risk is high. EYLEA HD and EYLEA made up 31% of 2025 revenue, down from 42% in 2024, and Dupixent-related Sanofi revenue made up 41%, up from 32%.
Two distributor customers accounted for 77% of gross product revenue. The balance sheet is strong, with $18.9Bd in cash and marketable securities against $2.7B of debt and finance leases. The company initiated a quarterly dividend of $0.88 in 2025, raised it to $0.94 for 2026, and repurchased $3.46B of stock.
Near-term catalysts include FDA decisions on the EYLEA HD pre-filled syringe (Q2 2026) after an October 2025 CRL tied to a third-party filler, and on the Dupixent AFRS sBLA (February 2026). Additional items include the bullous pemphigoid EC decision, the cemdisiran myasthenia gravis NDA, and readouts for fianlimab and garetosmab. Biosimilar EYLEA entries are being settled ex-U.S. on dated timelines, and the Sanofi and Amgen litigation remains unresolved.
02—Key points
Key Highlights
- Revenue grew 1% to $14.34B, but mix shifted: net product sales fell 17% to $6.31B while collaboration revenue rose 21% to $7.33B, led by Sanofi (+30%) on Dupixent.
- U.S. EYLEA sales fell 42% to $2.75B on biosimilar competition and compounded bevacizumab substitution, while EYLEA HD U.S. sales rose 36% to $1.64B.
- Operating income fell 10% to $3.58B as R&D grew 14% to $5.85B and SG&A fell 9% to $2.70B. Net income rose 2% to $4.50B, helped by $1.70B of other income.
- Diluted EPS was $41.48 versus $38.34, helped by a lower share count after buybacks ($3.46B in 2025) and a 2025 effective tax rate of 13.9% versus 7.7%.
- Concentration is high: EYLEA HD and EYLEA were 31% of revenue, Sanofi collaboration revenue was 41%, and two distributors accounted for 77% of gross product revenue.
- Balance sheet is strong, with $18.9B in cash and marketable securities against about $2.7B of debt and finance leases. Quarterly dividend raised to $0.94 for 2026.
- Near-term catalysts include the FDA decision on the EYLEA HD pre-filled syringe (Q2 2026), the Dupixent AFRS decision (February 2026), and the cemdisiran NDA for myasthenia gravis (Q1 2026).
03—One dollar
04—Financials
Financial Highlights
Figures from 10-KFY2025filed February 4, 2026Financial Statements
FY2025 against FY2024
| Line item | FY2025FY2024 | Change |
|---|---|---|
| Revenue | $14.34B$14.20B | +1.0% |
| R&D Expenses | $5.85B$5.13B | +14.0% |
| SG&A Expenses | $2.70B$2.95B | −8.6% |
| Operating Expenses | $10.77B$10.21B | +5.4% |
| Operating Income | $3.58B$3.99B | −10.3% |
| Net Income | $4.50B$4.41B | +2.1% |
| EPS (Basic) | $43.07$40.90 | +5.3% |
| EPS (Diluted) | $41.48$38.34 | +8.2% |
| Shares Outstanding (Basic) | 104.60M107.90M | −3.1% |
| Shares Outstanding (Diluted) | 108.60M115.10M | −5.6% |
05—Questions
Frequently Asked Questions
Why did total revenue barely grow while product sales dropped sharply?
Product sales fell $1.32B, mainly from U.S. EYLEA (down $2.02B). Collaboration revenue rose $1.27B, mostly from Sanofi's $1.35B increase, which reflects Regeneron's share of Dupixent profits. The shift means revenue now depends more on partner-reported sales and less on products Regeneron records directly.
How much of the company's revenue depends on a few products or partners?
Very heavily. EYLEA HD and EYLEA U.S. sales were 31% of 2025 revenue, down from 42%. Sanofi collaboration revenue, mostly from Dupixent, was 41%, up from 32%. Two distributors accounted for 77% of gross product revenue, and Bayer handles ex-U.S. EYLEA commercialization and can terminate on six to twelve months' notice.
What are the key near-term regulatory and pipeline events?
The EYLEA HD pre-filled syringe FDA decision is expected in Q2 2026 after a 2025 CRL tied to Catalent's inspection, and the company submitted with a new filler. The Dupixent AFRS sBLA decision is due February 2026. The cemdisiran NDA for myasthenia gravis is planned for Q1 2026. Phase 3 data for fianlimab in melanoma and the garetosmab FOP filing decisions are expected in 2026. Itepekimab's COPD program is mixed after one Phase 3 trial failed.
Is the dividend sustainable, and how much capital is returned?
The company began paying a quarterly dividend in 2025 at $0.88 per share, raised it to $0.94 for 2026, and paid $370M in dividends in 2025. It also repurchased $3.46B of stock in 2025, leaving $1.49B under the $3.0B authorization. Operating cash flow was $4.98B and capital expenditures were $0.90B. Payouts are at the board's discretion, and the filing warns they could be reduced.
What are the main legal and biosimilar risks to EYLEA?
U.S. EYLEA lost exclusivity in May 2024 and faces additional biosimilar launches in the second half of 2026 under settlements. Ex-U.S. settlements with several biosimilar makers set launch dates between January and May 2026. Regeneron also faces a Department of Justice False Claims Act and Anti-Kickback case over patient-assistance support, along with RICO and securities class actions. Amgen has counterclaimed alleging antitrust violations, and the Sanofi collaboration litigation is pending.
06—Continue