Regeneron's Sanofi Profit Share Now Flows in Full as Dupixent Tops $6.5 Billion, While CIDEB siRNA Shows 70% Liver Fat Reduction
Third quarter 2026 earnings call, October 30, 2026
Regeneron reported third quarter revenue of $5.1 billion, up 36%, and non-GAAP EPS of $20.07, up 70%. The quality of the beat deserves scrutiny. A meaningful part of the earnings leverage came from the Sanofi collaboration, where Regeneron booked its full share of profits for the first time after Sanofi's development balance was repaid in the second quarter. The result is a step-change in the earnings base rather than a pure operating surprise, and it is one that should persist as long as Dupixent keeps growing.
Sanofi Economics Reset, With a $1 Billion Upfront Payment Coming
Collaboration revenue reached an all-time high of $2.7 billion, including $2.6 billion from Regeneron's share of profits, which rose 77% year-over-year. Dupixent global net sales, as reported by Sanofi, reached $6.5 billion, up 35% at constant currency, with U.S. sales up 40% to $5.1 billion. Management acknowledged that gross-to-net favorability contributed to the U.S. figure, so the underlying demand growth is somewhat lower than the headline. For a product nearly 10 years on the market, the trajectory remains exceptional.
The recently amended alliance adds four next-generation long-acting antibodies, all invented at Regeneron, with development and commercialization costs and global profits shared 50-50. Because R&D costs will be co-funded as incurred, no new development balance will accrue. Existing economics on Dupixent and Kevzara are unchanged. Regeneron will record the full $1 billion upfront payment as collaboration revenue in the fourth quarter, and future milestones will be recognized in full when achieved. Regeneron leads R&D, Sanofi leads commercialization, with what CEO Leonard Schleifer described as "greater transparency and increased participation by Regeneron." He also credited Sanofi leadership for helping reset the relationship: "We have a very good relationship now with Sanofi. I think we're back on a very strong track."
The four candidates are a lead IL-13 antibody with a target dosing interval of every 3 to 6 months, a long-acting IL-4/13 bispecific, a long-acting IL-4 receptor alpha antibody and an IL-4 ligand antibody. The IL-13 antibody is in a first-in-human atopic dermatitis study, with registrational trials expected in late 2027 and 2028. The other three should enter the clinic next year. Chief Scientific Officer George Yancopoulos positioned the programs against competitors, arguing that rivals "are using heavily human engineered versions of previously existing old antibodies that were generated decades ago," and that "human engineering generally results in more problems than advances," citing antidrug antibodies. That is a pointed claim, and it remains untested head to head. Management declined to say whether these assets are lifecycle protection, franchise expansion or replacement for Dupixent, with Schleifer saying the call was not the format to "unveil our strategy."
CIDEB siRNA: Striking Early MASH Data, Still Small and Early
The most notable new clinical disclosure was first-in-human data for the CIDEB siRNA in MASH, to be presented at the Liver Meeting in November. In 40 participants, a single dose reduced liver fat by approximately 70% on average from baseline at 12 weeks, bringing mean liver fat to near or below the upper limit of normal at every dose level tested. The effect was durable through 24 weeks of follow-up, with improvements in liver enzymes. The target came from the Regeneron Genetics Center, which found that loss-of-function CIDEB variants protect against fatty liver disease and cirrhosis.
Yancopoulos argued that existing approaches act indirectly, through weight loss in the case of semaglutide or through separate mechanisms in the case of Madrigal's product, whereas this is "the first pathway that directly involves a genetically validated target." He called the liver fat reductions "unprecedented in the rapidity of onset and the depth." Investors should note that liver fat is a surrogate, and the data set is small. Management did not address questions on antifibrotic activity, F4 versus F2/F3 populations, or regulatory endpoints, deferring to a Regeneron Roundtable on November 10. The company is moving rapidly toward registration-enabling studies.
New Mid-Stage Franchises in POTS and Ovarian Cancer
Regeneron also highlighted postural orthostatic tachycardia syndrome, with no FDA-approved therapies and an estimated 500,000 to several million U.S. patients. Phase II data for baloncibart showed that a single high-dose treatment improved tachycardia and orthostatic symptoms for 4 weeks, apparently through durable restoration of intravascular volume. A potentially registrational study is planned for the first half of 2027, pending regulatory feedback. Full data come in November at the American Autonomic Society Congress.
In low-grade serous ovarian cancer, ubamatamab, a MUC16xCD3 bispecific, showed an approximately 70% objective response rate with prolonged progression-free survival and no biomarker selection. Historical chemotherapy and endocrine therapy response rates are below 15%, and the only approved therapy achieved 44%, limited to the roughly 30% of patients with a specific biomarker. A potentially registrational cohort is enrolling, and a confirmatory Phase III is planned for mid-2027. This is a rare indication, so the commercial scale is modest, but the activity signal supports the broader MUC16 platform.
Core Brands: EYLEA HD Accelerates, Legacy EYLEA Erodes
EYLEA HD U.S. net sales were $699 million, up 62%, with physician unit demand up 20% sequentially, helped by the retinal vein occlusion indication and greater dosing flexibility. The franchise overall was less impressive: combined EYLEA HD and EYLEA U.S. sales were $1.1 billion, down 1%. Legacy EYLEA fell 41% to $400 million, with unit demand down by a high single-digit percentage and partially cushioned by favorable gross-to-net adjustments. Both products also benefited modestly from end-of-quarter shipment timing, which flatters the quarter.
For the fourth quarter, management guided to roughly 10% sequential EYLEA HD unit demand growth, partly offset by ongoing pricing pressure, for full-year growth of over 50%. EYLEA unit demand is expected to decline in the low to mid-teens sequentially, amid additional aflibercept 2 mg biosimilar launches. A decision on the EYLEA HD prefilled syringe is expected before year-end, and management sees it as important to sustaining 2027 momentum.
Libtayo set another record at $550 million globally, up 51% at constant currency, with U.S. sales up 81% to $396 million, supported by the adjuvant cutaneous squamous cell carcinoma approval. The annualized run rate is about $2.2 billion. An every-6-week dosing regimen with infusions as short as 15 minutes has a positive CHMP opinion, and an FDA decision is due by March 2027. Lynozyfic, by contrast, was described plainly: "we expect Lynozyfic growth to remain modest" until it moves into earlier lines, with pivotal readouts starting in 2027.
Near-Term Catalysts and Pipeline Timing
An FDA decision on cemdisiran for generalized myasthenia gravis is due in November, which would make it the first siRNA in the indication, with quarterly subcutaneous dosing. Management said the company is "launch ready" but offered little on strategy or target audience. Pivotal PNH results for the cemdisiran and pozelimab combination are expected by year-end, and the company characterized lead-in cohort data as suggesting best-in-class control of hemolysis. Asked about switching dynamics in a patient population described as sticky, Marion McCourt said additional clinical differentiation data will be needed. The geographic atrophy interim readout from the systemic C5 program was pushed to early 2027.
The Factor XI antibody program now has all but one Phase III study enrolling, with the final secondary stroke prevention trial due to start by year-end. Pivotal knee replacement data begin next year, with others in 2028 and beyond. Odronextamab has a February 2027 FDA action date in relapsed/refractory DLBCL. Olatorepatide, in-licensed from Hansoh, will enter a global Phase III program, including a co-formulation with Praluent, with registrational studies of the combination planned next year. Yancopoulos stressed differentiation beyond weight loss, saying Regeneron does not want to compete with "a me-too." A new IgE-selective plasma cell bispecific for food allergy is expected to enter the clinic in the first half of 2027, following earlier work combining a BCMA bispecific with Dupixent.
Spending Rises, and Business Development Stays Opportunistic
CFO Christopher Fenimore guided 2027 R&D expense up by a mid-teens percentage, reflecting more than 15 Phase III starts this year across myeloma, anticoagulation and obesity. He also guided 100 to 200 basis points of upward pressure on the 2027 tax rate. Third quarter R&D was $1.7 billion and SG&A $588 million, up 9%. Other revenue included roughly $60 million of one-time Ilaris royalty catch-up that will not recur in the fourth quarter. No Inmazeb revenue is expected in the fourth quarter ahead of BARDA supply beginning in late 2027. Those items temper fourth quarter comparisons.
The balance sheet remains a strategic asset, with $16.2 billion of cash and marketable securities net of debt and $2.9 billion of free cash flow over nine months. The company repurchased $2.3 billion of stock in that period, expects about $3 billion for the year and has $2.2 billion of authorization remaining. On business development, management said it is open at all stages, from platforms to commercial-stage products, with a "sharp focus on valuation and strategic fit." Yancopoulos was blunt that most external opportunities compare unfavorably to the internal pipeline. Asked about breadth risk, Schleifer conceded the concern: "It doesn't mean we're going to be perfect, but we are going to strive to." With roughly 50 clinical programs and a rising R&D budget, execution across so many specialties is the main risk to a otherwise strong set of results.