{"schema_version":"secwatch.filing_event.v1","accession":"0001804220-25-000020","form_type":"8-K","ticker":"REGN","cik":"0000872589","company_name":"REGENERON PHARMACEUTICALS, INC.","filed_at":"2025-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.531525+00:00","generated_at":"2026-05-23T04:30:00.226492+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Regeneron Q1 revenue down 4%, non-GAAP EPS falls 14%; lowers gross margin guidance","bullets":["Q1 2025 revenue $3.03B (-4% YoY); GAAP EPS $7.27 (+16%), non-GAAP EPS $8.22 (-14%).","Dupixent global net sales (Sanofi) up 19% to $3.67B; EYLEA HD US up 54% but total EYLEA franchise down 26% to $1.04B.","FDA issued CRL for EYLEA HD pre-filled syringe (non-safety, third-party supplier issue) and separate CRL denying extended dosing beyond every 16 weeks.","Lowers 2025 GAAP gross margin guidance to 83%-84%, non-GAAP to 86%-87% (prior 84%-85% and 87%-88%).","Settled EYLEA biosimilar litigation with Biocon; launch precluded until H2 2026; entered 10-year manufacturing agreement with Fujifilm."],"urls":{"canonical":"https://secwatch.observer/filing/0001804220-25-000020","json":"https://secwatch.observer/filing/0001804220-25-000020.json","markdown":"https://secwatch.observer/filing/0001804220-25-000020.md","text":"https://secwatch.observer/filing/0001804220-25-000020.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/872589/000180422025000020/0001804220-25-000020-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/872589/000180422025000020/regn-20250429.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T04:30:00.226492+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}