Regeneron Q1 2026 Financial Results: Growth and Strategic Progress

Key highlights from Regeneron’s First Quarter 2026 financial and operating results

1) Strong top- and bottom-line growth (non-GAAP)

• Total revenues: $3.6 billion, up 19% year over year (vs. Q1 2025). ¹
• Diluted net income per share (non-GAAP basis): $9.47, up 15%, on net income of $1.0 billion. ¹
• Management emphasized double-digit growth on both the top and bottom line. ¹

2) Collaboration revenues and profit share stepped up

• Total Sanofi collaboration revenues: $1.6 billion in the quarter, including $1.5 billion related to Regeneron’s share of collaboration profits. ¹
• Sanofi share of collaboration profits: up 42% year over year, attributed to DUPIXENT sales growth and improving collaboration margins. ¹
• Sanofi development balance repayment expectation: management stated it expects the Sanofi development balance to be fully repaid by the end of Q2 2026, implying Sanofi collaboration revenue should step up starting in Q3 2026 to reflect the full share of collaboration profits. ¹

3) Product performance: DUPIXENT, EYLEA HD, and Libtayo drove growth

DUPIXENT

• Global DUPIXENT net sales: $4.9 billion, up 31% on a constant currency basis. ²
• Commentary also framed growth as broad-based across indications and geographies. ²

EYLEA HD / EYLEA

• EYLEA and EYLEA 8 mg (outside U.S.) net sales: $729 million, including $333 million of EYLEA 8 mg. ¹
• EYLEA HD (U.S.) net product sales: $468 million, up 52% year over year. ²
• EYLEA HD physician adoption: management cited encouraging adoption and 10% sequential demand growth for EYLEA HD during the quarter, notwithstanding typical seasonality. ³
• EYLEA (U.S.) net sales: $473 million, down 36% year over year, attributed to conversion to EYLEA HD, competitive pressures, and patient affordability issues, with expectations for ongoing negative impact from inventory dynamics into Q2. ³

Libtayo

• Global Libtayo product sales: $438 million, up 54% year over year. ⁴
• In the U.S., Libtayo net sales: $286 million, with management describing it as continuing a strong trajectory and noting growth drivers including adjuvant CSCC launch momentum. ⁵

4) Other revenue surged (non-product/royalty and profit-share items)

• Other revenue: up 109% to $171 million in Q1, including $101 million from Regeneron’s share of profits from ARCALYST and royalty income from Ilaris. ¹

5) Operating expense profile: continued heavy R&D investment and targeted SG&A spending

• R&D expense: $1.4 billion, reflecting ongoing investments in the pipeline, including late-stage programs in hematology/oncology and complement-mediated diseases. ¹
• SG&A: $560 million, reflecting investments to support the launch of Libtayo and adjuvant CSCC, and to drive EYLEA HD growth. ¹

6) Gross margin: GAAP pressured by a manufacturing interruption; non-GAAP remains strong

• Non-GAAP gross margin on net product sales: 86%. ⁶
• GAAP gross margin: 76%, negatively impacted by costs tied to a temporary interruption in bulk manufacturing at the Limerick, Ireland site. ⁶
• Manufacturing status and outlook: management said it resumed initial production and expects full production by end of Q2, and therefore anticipates GAAP gross margin will continue to be negatively impacted in Q2 as production returns to normal. ⁶
• Management updated GAAP gross margin guidance to 77%–78%, reflecting actual/expected costs from the manufacturing interruption. ⁶

7) Cash generation and capital allocation were notable

• Free cash flow: $848 million in Q1. ⁶
• Ending cash and marketable securities less debt: $15.8 billion at quarter end. ⁶
• Share repurchases: $800 million repurchased in the quarter. ⁶
• New authorization: board authorized an additional $3 billion share repurchase program, leaving about $3.4 billion available for repurchases “as of today.” ⁶

8) Operating updates: regulatory and market execution points

EYLEA HD regulatory / manufacturing

• Management noted resubmission for FDA approval for the EYLEA HD prefilled syringe (Catalent Indiana), after an FDA site reinspection. ²
• Also noted a pending regulatory application regarding a second contract manufacturer for PFS, with management expecting a decision on one or both applications during the quarter. ²

Capital-market “operating tone”

• The company highlighted a disciplined approach to capital allocation alongside strong commercial execution in key growth products and pipeline progress. ²

9) Select pipeline and clinical milestones referenced during the quarter

While the question is focused on financial/operating results, management also connected operating momentum to clinical progress:

• Otarmeni received FDA approval for genetic hearing loss, and management stated Regeneron is committed to offering it for free. ⁴
• Positive Phase III data for cemdisiran in generalized myasthenia gravis was presented, and management said it anticipates an FDA decision in Q4 after submission using a priority review voucher. ⁴
• Lynozyfic and odronextamab clinical progress continued as described, including ongoing Phase III programs and enrollment status for first-line follicular lymphoma. ⁷

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Bottom line

Regeneron’s Q1 2026 featured 19% revenue growth to $3.6B and 15% growth in diluted EPS to $9.47 (non-GAAP framing), supported by strong commercial momentum in DUPIXENT, EYLEA HD/EYLEA conversion dynamics, and Libtayo growth, plus higher Sanofi collaboration profit share. ¹² Operating execution also showed strong free cash flow ($848M) and continued aggressive share repurchases (including a new $3B authorization), while GAAP gross margin was pressured by a temporary manufacturing interruption in Ireland with an expected normalization path by end of Q2. ⁶