REGN · Q1 2026 Earnings

Cautious

Regeneron Pharmaceuticals

Reported April 29, 2026

30-second summary

Revenue of $3.605B grew 19% YoY and beat consensus by 3.6%, driven by EYLEA HD U.S. (+52%), Libtayo global (+54%), and Dupixent (+33% Sanofi-recorded). Non-GAAP EPS of $9.47 beat by 6.4%. But the FY2026 GAAP gross margin guide was cut to 77–78% (from 79–80%) as a temporary interruption of bulk manufacturing at Regeneron's own Limerick, Ireland facility — due to unanticipated facility repairs that commenced in Q1 — is still unwinding. Production resumed in Q2 with normalization expected by end of Q2. Separately, the EYLEA HD pre-filled syringe PDUFA at third-party filler Catalent missed April, with a decision now expected in Q2. The pipeline catalysts (fianlimab melanoma readout, C5 franchise approval cycle) are intact, but execution risk on the manufacturing supply chain — now spanning both in-house bulk and third-party filling — is a near-term overhang management is openly managing.

Headline numbers

EPS

Q1 FY2026

$9.47

+6.3% vs est.

Revenue

Q1 FY2026

$3.60B

+19.0% YoY

+3.6% vs est.

Gross margin

Q1 FY2026

76.0%

Free cash flow

Q1 FY2026

$0.85B

Operating margin

Q1 FY2026

17.8%

Key financials

Q1 FY2026

Metric	Q1 FY2026	YoY	Q4 FY2025	QoQ
Revenue	$3.60B	+19.0%	$3.88B	-7.2%
EPS	$9.47	—	$11.44	-17.2%
Gross margin	76.0%	—	81.0%	-500bps
Operating margin	17.8%	—	22.6%	-480bps
Free cash flow	$0.85B	—	—	—

Guidance

Significantly raised full-year R&D and capex guidance amid manufacturing disruption and margin headwinds, signaling aggressive R&D investment and facility r

Guidance is issued for the full year only, refreshed each quarter. Prior and new below are the same FY updated this quarter.

Changes to prior guidance

Metric	Period	Prior guide	New guide	Δ	Result
GAAP R&D expense	FY 2026	$5.680–$5.750 billion	$6.450–$6.680 billion	+$0.70–0.93 billion (+12–16% increase)	Raised
Non-GAAP R&D expense	FY 2026	$5.150–$5.200 billion	$5.900–$6.100 billion	+$0.70–0.95 billion (+14–18% increase)	Raised
GAAP SG&A expense	FY 2026	$2.775–$2.845 billion	$2.860–$3.040 billion	+$0.085–0.265 billion (+3–9% increase)	Raised
Non-GAAP SG&A expense	FY 2026	$2.400–$2.450 billion	$2.500–$2.650 billion	+$0.10–0.25 billion (+4–10% increase)	Raised
GAAP gross margin on net product sales	FY 2026	Approximately 82%	79%–80%	-2 to -3 percentage points	Lowered
GAAP COCM	FY 2026	$950 million–$1.000 billion	$940 million–$1.020 billion	Low-end -$10M; high-end +$20M (range widened, midpoint ~-$5M)	Lowered
Capital expenditures	FY 2026	$850–$890 million	$1.100–$1.300 billion	+$0.210–0.450 billion (+24–53% increase)	Raised
GAAP effective tax rate	FY 2026	Approximately 14%	12%–14%	Range introduced; low-end -200 bps vs prior point estimate	Raised
Non-GAAP effective tax rate	FY 2026	Approximately 12%	13%–15%	+1 to +3 percentage points	Lowered

Reaffirmed unchanged this quarter: Non-GAAP gross margin on net product sales (83%–84%), Non-GAAP COCM ($940 million–$1.020 billion)

Segment KPIs

Q1 FY2026

Segment	Q1 FY2026	YoY
EYLEA HD - U.S.	$0.468B	+52.0%
EYLEA (total HD + legacy) - U.S.	$0.941B	-10.0%
Libtayo - Global	$0.438B	+54.0%
Dupixent (recorded by Sanofi)	$4.88B	+33.0%
Praluent - U.S.	$0.067B	+18.0%
Kevzara (recorded by Sanofi)	$0.145B	+24.0%
Sanofi collaboration revenue	$1.605B	+36.0%
Dupixent global net sales growth	+33% YoY	—
EYLEA HD U.S. net sales growth	+52% YoY	—
Libtayo global net sales growth	+54% YoY	—

Other KPIs

Q1 FY2026

Segment	Q1 FY2026
Total revenue growth	+19% YoY
Non-GAAP EPS growth	+15% YoY
Non-GAAP gross margin on net product sales	86%
Free cash flow	$848.3 million
R&D spending (non-GAAP)	$1,408.4 million

Management tone

Narrative arc: Catalent filling delays (Q2 2025) → confident category leadership and 18 Phase III roadmap (Q4 2025) → in-house Limerick bulk manufacturing interruption plus continued Catalent PFS delay, GAAP margin cut, pipeline conviction undimmed (Q1 2026).

The supply chain story this quarter splits into two distinct issues. First, a temporary interruption of bulk manufacturing at Regeneron's own Limerick, Ireland facility due to unanticipated facility repairs that commenced in Q1 drove the GAAP margin cut; this is in-house, not a third-party issue, and management says product availability is unaffected. Second, separately, the EYLEA HD pre-filled syringe PDUFA at third-party filler Catalent's Indiana site was missed in April, with FDA action on one or both PFS applications now expected in Q2 following a site re-inspection. The two issues affect different parts of the supply chain, but together they make manufacturing the dominant near-term risk vector for the franchise.

The pipeline rhetoric did not soften. In Q4 management committed to 18 Phase III initiations and at least four FDA approvals in 2026; this quarter the metastatic melanoma Phase 3 readout for fianlimab + cemiplimab is reaffirmed for Q2 2026, the adjuvant melanoma study continues post-first-interim, and the cemdisiran (C5 siRNA) NDA in myasthenia gravis was submitted with FDA decision expected in Q4. Otarmeni (lunsotogene parvec, formerly DB-OTO) received accelerated FDA approval as the first gene therapy for genetic hearing loss — and Regeneron will provide it for free in the U.S. The catalyst calendar is intact. The contrast — pipeline conviction intact while manufacturing slips — is the central tension this quarter.

The obesity combination moved from concept to commercial framing. Per George's prepared remarks, Hanso reported positive Phase 2 results in China for olatorepatide (in-licensed GLP/GIP agonist) in a 604-patient randomized trial across 33 sites, meeting co-primary endpoints with up to 19% mean body weight loss at week 48 and an encouraging GI tolerability profile. Compared "fairly cross-trial" to a prior Chinese tirzepatide obesity study. Phase 3 starts are planned later in 2026 in obesity and in obesity + T2D, and the first clinical study of the olatorepatide + Praluent weekly combination is initiating shortly. The metabolic franchise is now positioned as a near-term competitive entrant, not optionality.

Q&A highlights

Tyler Van Buren · TD Cowan

Given Dupixent's strong performance trajectory toward exceeding $30 billion in global sales, should Regeneron pursue lifecycle expansion efforts within the Sanofi collaboration versus independently, particularly to capitalize on the Dupixent rebate wall before patent expiration?

Len stated Regeneron is open-minded to transactions and leveraging development and commercial capabilities, whether through collaboration with Sanofi's new CEO Belen Garijo or independently. Management emphasized they can execute lifecycle opportunities themselves but welcomes partnership discussions.

Dupixent approaching $20 billion annualized global net salesSignificant room for further market penetration across indicationsMultiple lifecycle expansion candidates in development (extended-interval Dupixent, IL-13 antibody, IL-4 agents)

Evan Siegerman · BMO Capital Markets

How is Regeneron approaching commercial development of the GLP-1/GIP plus Proluent combination, and what strategies will accelerate development to remain competitive in the rapidly evolving metabolic disease market?

George and Len emphasized the combination would offer weight loss comparable to terzepatide plus >50% LDL-C reduction and cardiovascular outcome benefits, creating a differentiated product. They highlighted China Phase 2 data showing comparable weight loss efficacy, co-formulation plans using auto-injectors, and competitive pricing strategy. George noted GLP-1 alone provides minimal lipid benefit, making the combination a meaningful add-on.

Cross-trial comparison to terzepatide shows comparable or superior weight loss in China Phase 250-60% LDL cholesterol reduction versus GLP-1 alone (few points)Co-formulated auto-injector approach plannedPhase 3 programs planned to initiate later in 2026 for obesity and obesity + type 2 diabetes

David Risinger · Leerink Partners

Given investor skepticism about pipeline candidates' commercial viability versus established competitors, which late-stage development candidates within 18 months have the greatest potential to generate multi-billion dollar peak sales?

Len highlighted C5 franchise (multiple Phase 3 trials with approvals/data coming), Factor XI anticoagulation program (11 Phase 3 trials), Fianlumab plus Liptio in melanoma, Linazific and Ojanextamab bispecifics in myeloma/lymphoma, and obesity combination opportunity. Referenced past success producing two $10B+ blockbusters from internal pipeline as proof of capability.

C5 franchise: multiple Phase 3 trials ongoing with approval actions and data expectedFactor XI: 11 Phase 3 trials in anticoagulation (massive opportunity per management)Fianlumab + Liptio: Phase 3 metastatic melanoma results expected Q2 2026Linazific + Ojanextamab: bispecific programs in myeloma and follicular lymphoma ongoing

Corey Kasimoff · Evercore ISI

Regarding infection risk concerns with bcma bispecifics (Linazific), how does Regeneron's data address physician pushback on adoption, particularly for earlier-stage patients?

George countered infection risk concerns by emphasizing: (1) disease itself carries substantial infectious risk; (2) detailed published data shows infectious risk decreases over time with continued treatment and better disease control/bone marrow function; (3) Linazific's overall side effect and tolerability profile, including infection management, is very promising and competitive/best-in-class; expects bispecifics to become dominant class.

Infectious risk goes down over time with longer treatment and better disease controlImproved bone marrow function with disease control reduces infection riskLinazific positioned as competitive or best-in-class across all safety and efficacy parametersBispecifics expected to become dominant treatment class for multiple myeloma and precursors

Christopher Schott · JP Morgan

What drove Liptio's strong Q1 performance; was there any one-time benefit; how much came from the new adjuvant CSCC indication; and is this a sustainable baseline for growth?

Marion attributed performance to broad advances in skin indications (adjuvant CSCC with strong enthusiasm and clinical differentiation), continued strength in lung cancer (U.S. and international), and noted the quarter benefited from some favorable inventory comparisons versus prior year. Characterized as very strong quarter with some year-over-year timing benefits.

Global Liptio net sales: $438 million (Q1 2026)U.S. net sales: $286 millionStrong uptake in newly-launched adjuvant CSCC indicationSecond-most prescribed first-line immunotherapy in NSCLC

Answers to last quarter's watch list

EYLEA HD trajectory and Q1 combined U.S. retina print — Combined U.S. retina (EYLEA + EYLEA HD) printed $941M, breaching the $1.0B watch line. EYLEA HD now contributes half of net U.S. retina sales (parity crossed), and physician unit demand grew 10% sequentially despite reported sales declining 7% sequentially on wholesaler inventory normalization. Status: Resolved (mixed — demand trajectory healthy, reported revenue softer)

Aflibercept 2mg biosimilar timing detail for 2H26 — Samsung biosimilar entry is now precluded in the U.S. until January 2027 following the February 2026 patent litigation settlement, removing one expected 2H26 entrant. Other biosimilar timing remains undisclosed; Marion flagged "the potential launch of additional biosimilars in the second half of the year" as a Q2 EYLEA demand headwind. Status: Partially resolved

Non-GAAP gross margin actuals vs the new 83–84% guide — Q1 non-GAAP gross margin on net product sales printed 86%, above the 83–84% FY guide — but Q1 only partially captured the Limerick interruption that drove the GAAP cut to 77–78%. Read-across to the FY band is muddy; Q2 will be the cleaner test.

Continue monitoring

Linvoseltamab Phase III initiation pace — Pipeline rhetoric reaffirmed (Kasimoff Q&A reinforced linvoseltamab's competitive positioning vs other BCMA bispecifics); pivotal study results expected by early 2027 in prior-line myeloma and MRD negativity in 2028 in first-line transplant-ineligible patients.

Continue monitoring

Fianlimab + Libtayo melanoma readouts (1H26) — Press release and Q&A both reaffirm metastatic melanoma Phase 3 readout in Q2 2026 (on track, with PFS primary analysis on full enrolled population at minimum six-month follow-up). Adjuvant study continues post-first-interim with second interim and possible final analysis in 2H26. Timeline holds.

Continue monitoring

R&D burn cadence against the $5.9–$6.1B non-GAAP guide — Q1 non-GAAP R&D printed $1.408B, just below the $1.50B/quarter implied midpoint run-rate. The "spending to convert pipeline" narrative is tracking credibly.

Continue monitoring

What to watch into next quarter

EYLEA HD pre-filled syringe FDA decision in Q2 2026 — action on one or both applications expected during Q2 following Catalent Indiana re-inspection. A clean approval validates the Q4 catalyst slate; another slip extends the third-party filler issue.

Limerick bulk manufacturing normalization — management guided full production resumption "by the end of the second quarter of 2026." Watch whether Q2 GAAP gross margin on net product sales prints inside the new 77–78% FY band or below it, and whether non-GAAP GM holds the 83–84% band.

Fianlimab + cemiplimab metastatic melanoma Phase 3 readout (Q2 2026) — the single biggest near-term binary catalyst; PFS primary on full enrolled population with OS powered to detect substantial benefit.

Combined U.S. retina trajectory below $1.0B — with the $1.0B line breached in Q1, EYLEA U.S. demand guided to decline mid- to high-teens in Q2, and Marion calling out ~$20M of Q2 inventory absorption headwind. Watch whether EYLEA HD demand growth offsets enough to stabilize the combined franchise.

Libtayo Q2 organic growth ex-inventory — Q1's +54% included favorable inventory comparisons per Marion's prepared remarks; Q2 sets the clean baseline for whether adjuvant CSCC sustains a step-change or reverts toward the +16% Q4 trajectory.

Sanofi profit-share step-up in Q3 — Sanofi development balance expected fully repaid by end of Q2, after which Regeneron's full share of collaboration profits flows through — a mechanical tailwind to Sanofi collaboration revenue starting Q3.

Sources

Regeneron Q1 2026 press release (Exhibit 99.1): https://www.sec.gov/Archives/edgar/data/872589/000087258926000014/exhibit991q12026.htm
Regeneron Q1 2026 earnings call prepared remarks and Q&A
Tapebrief Q4 2025 REGN brief (prior watch list and trend context)

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