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Regeneron Pharmaceuticals, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 30 July 2026: press release. Guidance figures: 2 raised, 3 lowered. The quarter’s numbers.

Key takeaways

  • Revenue rose 17 percent: Total revenues were $4,291 million against $3,676 million. GAAP net income was $1,297 million, down 7%; non-GAAP net income was $1,543 million, up 8%. Source
  • Sanofi Development Balance fully repaid: The Sanofi Development Balance was fully repaid by the end of the second quarter. It will no longer reduce Sanofi collaboration revenue from the third quarter of 2026. Source
  • Dupixent global sales rose 38 percent: Dupixent global net sales, recorded by Sanofi, reached a new all-time high of $6.0 billion. Regeneron records its share of profits in collaboration revenue. Source
  • EYLEA U.S. sales fell 45 percent: EYLEA U.S. net sales were $412 million against $754 million. Total EYLEA HD and EYLEA U.S. sales were $1,008 million, down 12%. Source
  • Gross margin fell on Limerick interruption: GAAP gross margin on net product sales was 78%, against 83%, due to unabsorbed manufacturing costs from the temporary bulk production interruption at Limerick. Non-GAAP gross margin was 87%. Source
  • Cemdisiran accepted for gMG review: FDA will review the cemdisiran NDA under priority review using a Priority Review Voucher. European Commission decision is anticipated in the second half of 2027. Source
  • Fianlimab Phase 3 did not reach significance: The Phase 3 melanoma trial of fianlimab with cemiplimab did not reach statistical significance for progression-free survival against pembrolizumab monotherapy. Source
  • Share repurchases of $1.2 billion: Share repurchases were $1.2 billion in the quarter and $2.0 billion in the first half. $2.5 billion remained available under the repurchase programs at June 30, 2026. Source

“With approximately 50 clinical assets, we remain focused on translating our science into even more successful new medicines across a broad array of diseases.”

Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron

Guidance

AreaPeriodFigureAgainst last quarter
GAAP R&D Sourcefull year 2026$6.500 - $6.635 billion
Non-GAAP R&D Sourcefull year 2026$5.950 - $6.050 billion
GAAP SG&A Sourcefull year 2026$2.830 - $2.960 billionLowered from $2.860 - $3.040 billion
Non-GAAP SG&A Sourcefull year 2026$2.500 - $2.600 billionLowered from $2.500 - $2.650 billion
GAAP gross margin on net product sales Sourcefull year 202678% - 79%Raised from 77% - 78%
Non-GAAP gross margin on net product sales Sourcefull year 202684% - 85%Raised from 83% - 84%
GAAP COCM Sourcefull year 2026$985 million - $1.035 billion
Non-GAAP COCM Sourcefull year 2026$970 million - $1.020 billion
Capital expenditures Sourcefull year 2026$1.030 - $1.100 billionLowered from $1.100 - $1.200 billion
GAAP effective tax rate Sourcefull year 202613% - 14%
Non-GAAP effective tax rate Sourcefull year 202614% - 15%

What changed from last quarter

  • Guidance raised: Gross margin on net product sales guidance raised on both GAAP and non-GAAP bases. Source
  • Guidance lowered: GAAP SG&A guidance lowered at both ends; non-GAAP SG&A high end lowered. Source
  • Guidance lowered: Capital expenditure guidance lowered to $1.030 - $1.100 billion from $1.100 - $1.200 billion. Source
  • Ended: Sanofi Development Balance fully repaid by end of second quarter; it no longer reduces Sanofi collaboration revenue from the third quarter. Source
  • New: Cemdisiran regulatory submissions accepted by FDA and EMA for generalized myasthenia gravis. Source
  • New: Collaboration with Parabilis Medicines entered in May 2026 on the Helicon peptide platform. Source
  • New: Saratoga Springs manufacturing facility selected for FDA PreCheck Pilot Program. Source

Revenue and earnings results

  • Revenue rose 17 percent: Total revenues were $4,291 million against $3,676 million. GAAP net income was $1,297 million, down 7%; non-GAAP net income was $1,543 million, up 8%. Source
  • Non-GAAP EPS rose 11 percent: Non-GAAP diluted EPS was $14.29 against $12.89. GAAP diluted EPS was $12.23 against $12.81. Both figures include IPR&D charges of $1.02 and $0.99 per share. Source

Collaboration revenue and Sanofi

  • Sanofi collaboration revenue rose 51 percent: Sanofi collaboration revenue was $2,174 million against $1,444 million. Regeneron's share of antibody profits rose to $2.033 billion from $1.282 billion. Source
  • Profit share rose on Dupixent: The rise in profit share came mainly from higher profits tied to increased Dupixent sales, which Sanofi records and Regeneron shares through collaboration revenue. Source
  • Sanofi Development Balance fully repaid: The Sanofi Development Balance was fully repaid by the end of the second quarter. It will no longer reduce Sanofi collaboration revenue from the third quarter of 2026. Source
  • Bayer collaboration revenue declined: Bayer collaboration revenue was $276 million, down 33%. Regeneron's profit share on EYLEA 8 mg and EYLEA outside the United States was $227.3 million against $383.4 million. Source

“Second quarter revenues grew 17% and non-GAAP net income per share grew 11%, marking our second consecutive quarter of double-digit growth on both measures,”

Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron

Product sales by drug

  • Dupixent global sales rose 38 percent: Dupixent global net sales, recorded by Sanofi, reached a new all-time high of $6.0 billion. Regeneron records its share of profits in collaboration revenue. Source
  • EYLEA HD sales rose 52 percent: EYLEA HD U.S. net sales were $596 million. Higher volumes driven by increased demand were partly offset by a lower net selling price. Source
  • EYLEA U.S. sales fell 45 percent: EYLEA U.S. net sales were $412 million against $754 million. Total EYLEA HD and EYLEA U.S. sales were $1,008 million, down 12%. Source
  • Libtayo sales rose 30 percent: Global Libtayo net sales were $489 million. U.S. sales were $343 million, up 38%, and rest-of-world sales were $146 million, up 13%. Source
  • Praluent and Evkeeza sales rose: Praluent U.S. net sales were $75 million, up 14%. Evkeeza U.S. net sales were $53 million, up 29%. Source
  • Kevzara and other products: Kevzara global net sales were $206 million, up 35%. Other products were $85 million, up 17%. Lynozyfic global net sales were $17 million. Source

Costs, margins and tax

  • R&D spend rose on pipeline: GAAP R&D was $1,632 million, up 15%. Non-GAAP R&D was $1,500 million, up 17%. Management attributed the increase to the mid- and late-stage clinical pipeline. Source
  • Acquired IPR&D charge rose: Acquired IPR&D expense was $127 million against $10 million. It included up-front and opt-in payments under collaboration and licensing agreements. Source
  • Gross margin fell on Limerick interruption: GAAP gross margin on net product sales was 78%, against 83%, due to unabsorbed manufacturing costs from the temporary bulk production interruption at Limerick. Non-GAAP gross margin was 87%. Source
  • Limerick bulk production back to normal: Bulk manufacturing production at Limerick returned to normal levels by the end of the second quarter. Management said the interruption did not affect availability of any product. Source
  • SG&A and COCM movements: GAAP SG&A was $662 million, up 4%; non-GAAP SG&A was $574 million, up 6%. Cost of collaboration and contract manufacturing was $216 million, down 15%. Source
  • Effective tax rate rose: GAAP effective tax rate was 15.1%, against 8.4%. The prior-year quarter included release of liabilities after an IRS audit settlement, which did not recur. Source
  • Other income fell on securities gains: GAAP other income (expense), net was $245 million against $443 million. Net gains on marketable and other securities were $62 million against $250 million. Source

“we continue to invest confidently in our pipeline, U.S. manufacturing, and external innovation, while returning capital to shareholders”

Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron

Pipeline and regulatory milestones

  • Cemdisiran accepted for gMG review: FDA will review the cemdisiran NDA under priority review using a Priority Review Voucher. European Commission decision is anticipated in the second half of 2027. Source
  • Dupixent approved for CSU in children: FDA and European Commission approved Dupixent for chronic spontaneous urticaria in April 2026. The approval extends to children aged 2 to 11 who remain symptomatic on antihistamines. Source
  • EYLEA HD dosing extended to 20 weeks: In April 2026 the FDA approved longer EYLEA HD dosing intervals, up to every 20 weeks, for wet AMD and DME after one year of successful response. Source
  • Fianlimab Phase 3 did not reach significance: The Phase 3 melanoma trial of fianlimab with cemiplimab did not reach statistical significance for progression-free survival against pembrolizumab monotherapy. Source
  • Otarmeni accepted for EMA review: EMA accepted the Otarmeni marketing application for review under accelerated assessment, for biallelic OTOF variant-associated hearing loss. Source
  • Lynozyfic LINKER-AL2 results presented: Phase 1/2 LINKER-AL2 results for Lynozyfic in second-line-plus systemic AL amyloidosis were presented at ASCO 2026. A Phase 2 portion with registrational intent is underway. Source
  • Factor XI Phase 3 started in PAD: A Phase 3 study began in peripheral artery disease for cenvacibart and amrecibart, each an antibody to Factor XI, compared individually with standard of care. Source

Capital, cash and shareholder returns

  • Share repurchases of $1.2 billion: Share repurchases were $1.2 billion in the quarter and $2.0 billion in the first half. $2.5 billion remained available under the repurchase programs at June 30, 2026. Source
  • Free cash flow lower in first half: First-half free cash flow was $1,421.1 million against $1,741.2 million. Operating cash flow was $1,891.9 million and capital expenditures were $470.8 million. Source
  • Cash and securities declined slightly: Cash and marketable securities were $17,822.9 million at June 30, 2026, against $18,865.8 million at December 31, 2025. Source
  • Quarterly dividend of $0.94 declared: In July 2026 the board declared a cash dividend of $0.94 per share on common stock and Class A stock. Source
  • Nearly $3.0 billion deployed in first half: The CFO said nearly $3.0 billion was deployed in the first half across share repurchases, dividends, capital expenditures and business development. Source
  • Diluted share count declined: Weighted average diluted shares were 106.0 million in the quarter against 108.6 million a year earlier. Source

Strategy, partnerships and corporate updates

  • Parabilis platform collaboration: The company entered a May 2026 collaboration with Parabilis Medicines to discover and develop multiple therapeutic candidates on the Helicon peptide platform. Source
  • Saratoga Springs in FDA PreCheck: The FDA selected the Saratoga Springs, New York manufacturing facility, currently under construction, for the PreCheck Pilot Program supporting new U.S. pharmaceutical manufacturing. Source
  • Named to Dow Jones index: The company was named to the Dow Jones Best-in-Class World Index for corporate sustainability performance, for the seventh consecutive year. Source
  • Pipeline of about 50 candidates: Regeneron has about 50 product candidates in clinical development, including marketed products under investigation for additional indications. Source

Coming up, as management said on 30 July 2026

  • Collaboration profits to step up: Management expects a meaningful step-up in collaboration profits from the third quarter, once the Sanofi Development Balance no longer reduces revenue. Source
  • FDA target action date for cemdisiran: The FDA priority review of the cemdisiran NDA for gMG has a target action date in November 2026. Source
  • European decision on cemdisiran expected: A European Commission decision on cemdisiran for gMG is anticipated in the second half of 2027. Source
  • Dividend payable August 31: The $0.94 per share dividend is payable on August 31, 2026, to shareholders of record on August 18, 2026. Source

Figures management reported

FigureReported
Dupixent global net sales (recorded by Sanofi) Source$6.0 billion, up 38%
EYLEA HD U.S. net sales Source$596 million, up 52%
EYLEA U.S. net sales Source$412 million, down 45%
Libtayo global net sales Source$489 million, up 30%
Praluent U.S. net sales Source$75 million, up 14%
Evkeeza U.S. net sales Source$53 million, up 29%
Kevzara global net sales Source$206 million, up 35%
Lynozyfic global net sales Source$17 million
GAAP R&D expense Source$1,632 million, up 15%
Non-GAAP R&D expense Source$1,500 million, up 17%
Pipeline milestone: cemdisiran NDA SourcePriority review, target action date November 2026
Trial readout: fianlimab Phase 3 melanoma SourcePrimary PFS endpoint not statistically significant

Risks management discussed

  • Operational: The temporary Limerick bulk production interruption led to unabsorbed manufacturing costs that reduced gross margin in the quarter. Source
  • Demand: EYLEA U.S. sales face competitive pressure and patients transitioning to EYLEA HD, lowering EYLEA demand. Source
  • External: A lower net selling price reduced EYLEA HD sales growth, which management identified as offsetting volume gains. Source

Earlier plans management reported on

  • Met: Management states bulk manufacturing production at Limerick returned to normal levels by the end of the second quarter. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.