Regeneron's CD38 Inhibitor Pipeline Momentum: Can REGN Beat Q4 Expectations?

Regeneron Pharmaceuticals faces a critical earnings moment on January 30, 2026, when the biotech giant reports its fourth-quarter 2025 results. Investors will scrutinize whether the company’s diversified product portfolio—spanning respiratory therapeutics, ophthalmology, and emerging oncology assets including CD38 inhibitor candidates—can deliver the expected earnings beat.

The consensus expectations paint an optimistic picture: Wall Street projects revenues of $3.82 billion and earnings per share of $10.56. Regeneron has historically beaten earnings estimates in three of the past four quarters, posting an average surprise margin of 21.81%. Most recently, the company crushed earnings expectations by 25.32%, signaling strong operational momentum heading into 2026.

Our proprietary forecasting model suggests another earnings beat is in the cards. With an Earnings ESP of +0.82% (consensus estimate at $10.56 versus the most accurate estimate at $10.65 per share) combined with a Zacks Rank #1 (Strong Buy), the probability of outperforming leans decidedly in Regeneron’s favor.

Dupixent Profits and Eylea HD Surge: The Revenue Drivers

The profit engine for Regeneron continues to run on two cylinders: soaring Dupixent royalties and accelerating Eylea HD adoption.

Dupixent, developed in partnership with Sanofi, has become a blockbuster in its own right. The asthma and dermatology drug’s reach spans multiple approved indications—atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous pemphigoid. Regeneron recognizes its share of profits from global Dupixent sales through the collaboration agreement, and preliminary results suggest Q4 marked another quarter of solid profit growth. Strong demand across all therapeutic applications is expected to have bolstered Regeneron’s bottom line.

Eylea, the company’s flagship ophthalmology drug co-developed with Bayer, faced mounting competitive pressures in recent quarters due to rival therapies like Vabysmo. U.S. Eylea sales dropped to $577 million in Q4. However, Regeneron’s counter-strategy is paying dividends. The newly formulated Eylea HD (higher dose) captured $506 million in U.S. sales during the same period, suggesting a seamless patient transition and offsetting much of the franchise’s revenue headwinds.

In November 2025, regulators expanded Eylea HD’s therapeutic utility. The FDA approved the 8 mg injection formulation for macular edema following retinal vein occlusion, with flexible dosing intervals extending to every eight weeks. This regulatory tailwind should continue supporting Eylea HD uptake into 2026 and beyond.

Oncology Expansion: CD38-Targeting Drugs Power New Growth

Beyond respiratory and ophthalmology, Regeneron is aggressively building an oncology franchise designed to reduce reliance on Eylea and create new revenue streams. The company’s immunology expertise positions it well in hematologic malignancies, particularly through CD38-directed therapeutics.

Lynozyfic (linvoseltamab-gcpt), a novel CD38 inhibitor targeting relapsed/refractory multiple myeloma, represents the cutting edge of Regeneron’s oncology strategy. The drug garnered FDA accelerated approval and is also authorized in the European Union to treat adults with multiple myeloma after at least three prior therapy lines. CD38 inhibitors have emerged as a critical pillar in modern myeloma treatment paradigms, and Regeneron’s entry into this space underscores its commitment to hematologic cancers. The CD38-targeting mechanism offers synergistic potential when combined with existing myeloma therapeutics, positioning Lynozyfic as a meaningful addition to treatment arsenals.

Ordspono (odronextamab), addressing relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, has also gained EU approval, further strengthening the oncology portfolio. Meanwhile, Libtayo continues its ascent in non-melanoma skin cancer indications. Recent label expansions in Europe for adjuvant cutaneous squamous cell carcinoma (CSCC) therapy mirror earlier FDA approvals, broadening the drug’s market potential. Analysts estimate Libtayo will generate approximately $482 million in Q4 sales, driven by mounting demand and geographic expansion.

Earnings Forecast and Investment Signals

Regeneron’s bottom-line performance will also benefit from disciplined capital allocation. In February 2025, management authorized a fresh $3.0 billion share repurchase program, with $2.156 billion remaining available as of September 30, 2025. This buyback initiative should provide a modest tailwind to per-share earnings, offsetting any potential margin compression from rising R&D investments tied to pipeline advancement.

Operating expenses are anticipated to have climbed in Q4 due to accelerated drug development efforts, yet the combination of higher Dupixent profits, strong Eylea HD adoption, and emerging oncology revenue should more than compensate. Over the past 12 months, Regeneron shares have appreciated 12.2%, slightly trailing the broader pharmaceutical industry’s 17.1% gain—suggesting potential upside if earnings meet or exceed expectations.

Investors monitoring CD38 inhibitor developments and oncology market trends will be watching closely. For a company in transition from a single-franchise dependency to a diversified pharmaceutical powerhouse, Q4 2025 results will signal whether Regeneron’s strategic pivot is gaining traction.

Comparative Peer Momentum

Several peers also exhibit the favorable combination of positive Earnings ESP and strong Zacks rankings:

Veracyte (VCYT) boasts an Earnings ESP of +7.98% and Zacks Rank #1. The diagnostic company has beaten earnings in all four trailing quarters, averaging a 45.12% surprise. Veracyte shares have surged 62.6% over the past six months.

Amneal Pharmaceuticals (AMRX) carries an Earnings ESP of +11.77% and Zacks Rank #2. The company beat earnings in three of four trailing quarters with an average 22.4% surprise. AMRX shares have climbed 71% in the past six months.

Novartis (NVS), reporting results on February 4, 2026, posts an Earnings ESP of +1.16% and Zacks Rank #3, having beaten earnings in three of four trailing quarters with a 4.55% average surprise.