Analyst Conference Summary

Biotechnology

conference date: October 30, 2026 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2026 (Q3, third quarter 2026)

Forward-looking statements

Overview: Great quarter propelled by rapid Dupixent ramp.

Basic data (GAAP):

Revenue was $5.11 billion, up 19% sequentially from $4.29 billion and up 36% from $3.75 billion in the year-earlier quarter.

Net income was $1.95 billion, up 50% sequentially from $1.30 billion, and up 34% from $1.46 billion year-earlier.

Diluted Earnings Per Share (EPS) was $18.45, up 51% sequentially from $12.23 and up 35% from $13.62 year-earlier.

Guidance:

Slightly changed 2026 guidance, which is for expenses, not revenue or profit, to higher R&D expanse with lower SG&A expense. Resulting in slightly higher gross margins.

Conference Highlights:

Leonard S. Schleifer, CEO, said "This was an outstanding quarter for Regeneron, with Dupixent, EYLEA HD, and Libtayo each achieving record net sales. Our pipeline of about 50 product candidates is rapidly advancing. We expect an FDA decision for cemdisiran in generalized myasthenia gravis next month; our Phase 3 programs in multiple myeloma, lymphoma, anticoagulation, and obesity continue to advance; and we have generated encouraging early data in MASH, POTS, and ovarian cancer. Finally, we expanded our alliance with Sanofi to include four Regeneron-invented, next-generation, long-acting antibodies designed to build on the success of Dupixent." Strong commercial execution across the portfolio, together with the anticipated step-up in Sanofi collaboration revenue, drove a 36% increase in total revenues and a 70% increase in non-GAAP EPS.

Declared dividend of $0.94, payable November 31, 2026, of record November 18, 2026.

Boasted of large, diverse sales force ready to bring new products to market.

In Q3 Libtayo (cemiplimab) received Japanese approval for adjuvant treatment for cutaneous squamous cell carcinoma (CSCC) and for the treatment of metastatic or locally advanced CSCC. The EU CHMP adopted a posive opinion re alternative dosing schedule across already approved indications.

In Q3 Ordspono (odronextamab) was accepted for FDA review for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), PDUFA in February 2027.

In Q3 2026 Regeneron said that ubamatamab (MUC16 and CD3 bispecific antibody) showed a high rate of durable responses in an initial study in patients with advanced low-grade serous ovarian cancer (LGSOC). Regeneron is now enrolling a single-arm, potentially registrational LGSOC trial and is planning a confirmatory Phase 3 trial.

In Q3 2026 the FDA approved Pasatru (garetosmab) for symptoms of FOP (fibrodysplasia ossificans progressiva). 84-week results from the Phase 3 trial for Pasatru in adults with FOP demonstrated sustained efficacy in halting new, rogue bone growth and in significantly reducing disease flare-ups.

Regeneron is conducting a Phase 1/2 sutdy for an RNAi therapy for CIDEB/MASLD, with positive interim results. Greatly reduces liver fat. Presentation planned at ASSLD in November. Will initiate a Phase 3 study in metabolic dysfunction-associated steatohepatitis (MASH)/MASLD in Q4 2026.

Results from the Phase 2 study for baloncibart (NPR1 antagonist antibody) in postural orthostatic tachycardia syndrome (POTS) will be released in November 2026.

In Q3 2026 positive results were announced from the Phase 2 trial evaluating trevogrumab (myostatin antibody) for its potential to prevent lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in people living with obesity.

In October 2026, Regeneron and Sanofi amended their antibody collaboration, adding multiple next-generation, long-acting Regeneron-invented antibodies to the alliance. Regeneron received an up-front payment of $1.0 billion, and could receive up to an additional $7.0 billion upon the achievement of certain development, regulatory, and sales-based milestones. The companies will equally share development and commercialization costs, and share any future profits equally on a global basis.

In Q2 2026 cemdisiran was accepted for review by the FDA and EU for gMG. FDA decision due in November.

Working on an Eylea HD pre-filled syringe, which might become available before the end of 2026.

Hopes will report results from Phase 3 study for pozelimab (C5 antibody) in combination with cemdisiran (C5 siRNA therapy) in paroxysmal nocturnal hemoglobinuria (PNH) in Q4 2026 or Q1 2027 such that it will be best in class for PNH.

Regeneron is testing several potential cancer agents, including in combo with Libtayo and 8 different bispecifics, plus one CAR-T therapy. Continues to pursue siRNA therapies generated by Alnylam.

Future growth will be fueled by the breadth and depth of the pipeline. Genetic medicines portfolio pipeline has high potential future value.

Revenue by type: product sales $1.81 billion. Collaboration revenue $3.00 billion, including Dupixent sold by Sanofi. Other income $310 million.

Non-GAAP results: net income $2.15 billion, up 40% sequentially from $1.54 billion and up 67% from $1.29 billion year earlier. Diluted EPS was $20.07, up 40% sequentially from $14.29 and up 70% from $11.83 year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $18.9 billion, up sequentially from $17.8 billion. $2 billion long-term debt. Cash from operations, was $ billion, free cash flow $ million. Cap ex $ million. $ billion was used for shares repurchased in the quarter; $ billion authorization remains.

GAAP expenses of $3.07 billion consisted of: cost of goods sold $322 million; research and development $1.79 billion; acquired in-process R&D $22 million; selling, general and administrative $678 million; collaboration manufacturing costs $253 million. Leaving income from operations of $2.05 billion. Other income was $246 million. Interest expense $11 million. Income tax $335 million.

Q&A selective summary:

ASLD clinical data, competition? The other approaches to MASH are indirect. We address the genetic pathway. Protects against multiple liver diseases. Liver fat reductions from our siRNA are unprecedented. Confident can benefit in other liver diseases. Used large scale human genetics to target disease directly.

Cemdisiran launch? Preparation is well underway. More in November after the decision.

Would you be interested in an asset similar to Dupixent with Sanofi? Sure, open to anything, but the oral agents are a long way from the efficacy of Dupixent. Alliance is open, we will continue to build on Dupixent for a long time.

BD? We look at overall investment spend, internal and external, we are very productive. We have exciting preclinical programs. We are open to opportunities, prefer platforms, we are agnostic re early stage v. late stage. We think most of our best opportunities are internal.

AD competitive landscape? Hard to show better efficacy than Dupixent. It is hard to improve on mechanism. But there will be entries in the market. Human engineering of antibodies usually results in more problems than mouse antibodies. We will need to see the data.

MASH mechanism for fibrosis, other details? Bottom line is this pathway protects about multiple aspects of liver disease. No other pathway has shown this good of profile. Early clinical data are confirming out hypothesis. In November we will give more details on future trials.

Investment in vast obesity space? It does concern us, how to compete well in development and commercialization. We have vast experience and work with specialist. In obesity we don't want to have just another agent, we want to deliver something truly differentiated, perhaps lowering lipids and other risks.

PNH data, competition? Early results are exciting, but we need to see more data.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: