Regeneron Pharmaceuticals (NASDAQ: REGN) just posted a third quarter that bordered on defiant. Revenue climbed 36% to $5.1 billion, clearing the $4.56 billion consensus by nearly $550 million. Non-GAAP EPS hit $20.07, a 70% year-over-year jump that beat the $16.42 estimate by $3.65. This marks the third straight quarter of double-digit growth in both revenue and non-GAAP EPS. The portfolio is working.
Dupixent is the engine. Global net sales recorded by Sanofi rose 35% to a record $6.5 billion, with uptake continuing across approved indications. That growth fed straight into Regeneron's collaboration revenue: the company's share of profits from antibody commercialization jumped to $2.575 billion from $1.456 billion a year ago. The Sanofi Development Balance was fully repaid at the end of Q2, so Regeneron's profit share no longer carries that reduction. This structural shift added roughly $1.1 billion to collaboration revenue in the quarter. It's permanent now.
EYLEA HD is cannibalizing its predecessor, but the net effect is stabilizing. U.S. net sales of EYLEA HD rose 62% to $699 million, while standard EYLEA fell 41% to $400 million. Combined U.S. sales of the two products were essentially flat at $1.099 billion versus $1.112 billion a year ago. The transition is tracking to management's expectations: higher volumes of the higher-priced HD formulation are offsetting the decline in original EYLEA. The 62% growth rate for HD suggests patient conversion is accelerating, not stalling.
Libtayo global net sales reached $550 million, up 51% year over year, with U.S. sales surging 81% to $396 million. The oncology franchise is building momentum on label expansions, including recent Japanese approval for adjuvant CSCC and a positive CHMP opinion supporting less frequent dosing. The European Commission decision on the every-six-week regimen is expected in coming months.
The quarter also brought a $1.0 billion upfront payment from Sanofi, part of an expanded collaboration covering four next-generation long-acting immunology antibodies. Regeneron will recognize that payment as collaboration revenue in Q4. The deal includes up to $7.0 billion in future milestones, with costs and profits shared equally. This extends the Dupixent franchise's economic model into a new generation of assets. It also signals Sanofi's confidence in Regeneron's discovery engine.
Guidance updates back up the numbers. Regeneron raised its full-year GAAP gross margin on net product sales to approximately 80% from 78-79%, and non-GAAP gross margin to 86% from 84-85%. The improvement reflects favorable product mix as higher-margin EYLEA HD and Libtayo account for a growing share of sales. R&D guidance was raised by $100 million at both ends, to $6.60-$6.735 billion (GAAP) and $6.05-$6.15 billion (non-GAAP), reflecting pipeline advancement. SG&A guidance was lowered by $100 million, to $2.73-$2.86 billion (GAAP) and $2.40-$2.50 billion (non-GAAP). Operating leverage is improving.
Regeneron is entering a phase where top-line growth and margin expansion reinforce each other. The gross margin guidance raise is particularly telling: it stems not from cost cuts but from a structural shift toward higher-value products. Combined with the Sanofi Development Balance tailwind and the $1.0 billion upfront payment coming in Q4, the company has multiple levers pulling earnings higher. The $2.3 billion in share repurchases year-to-date (with $2.2 billion remaining) adds further EPS support.
What to watch: the FDA decision on cemdisiran in generalized myasthenia gravis, expected in November, and the planned initiation of a Phase 3 study in MASH/MASLD in Q4. Regeneron's pipeline of approximately 50 clinical candidates is advancing. Early data in MASH (70% average liver fat reduction at 12 weeks) and ovarian cancer (durable responses with ubamatamab) suggest the company is building its next wave of growth. For now, the current portfolio is delivering at a level that few large-cap biotechs can match.