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GLAUKOS Corp (GKOS)·Q1 2025 Earnings Summary

Executive Summary

  • Record Q1 2025 net sales of $106.7M (+25% YoY; +26% constant currency) with U.S. Glaucoma $59.1M (+41% YoY) and International Glaucoma $29.0M (+15% YoY; +19% cc); non-GAAP gross margin ~82% .
  • Results beat Wall Street consensus: Revenue $106.7M vs $102.8M*, and non-GAAP EPS ($0.22) vs ($0.35); EBITDA also better than consensus, driving guidance reaffirmation of FY25 net sales $475–$485M . Values retrieved from S&P Global.*
  • Management highlighted strong early adoption of iDose TR, broadening MAC reimbursement, and methodical rollout to commercial/Medicare Advantage; reiterated iDose ramp as a key 2025 growth driver .
  • Headwinds: MIGS LCDs continue to pressure U.S. stents (non‑iDose revenues guide to down mid‑single digits), FX and emerging competition internationally, and MDRP impact in corneal health .
  • Stock reaction catalysts: iDose TR reimbursement milestones (additional MACs adding professional fees), Epioxa NDA acceptance with Oct 20, 2025 PDUFA, and PRESERFLO 510(k) pivotal study initiation .

What Went Well and What Went Wrong

What Went Well

  • Strong top-line beat and broad-based growth: Q1 net sales $106.7M (+25% YoY), record U.S. Glaucoma $59.1M (+41% YoY), International Glaucoma $29.0M (+15% YoY) .
  • iDose TR momentum: “We are pioneering a brand-new therapeutic category that has the potential to reshape glaucoma management” — Tom Burns; iDose J-code payment streamlining in multiple MACs and professional fee schedules expanding .
  • Non-GAAP profitability trajectory improved: operating loss ($15.2M) vs ($32.8M) prior year; non-GAAP EPS ($0.22) vs ($0.70) prior year; benefited from lower amortization and absence of prior IPR&D charge .

What Went Wrong

  • U.S. stent franchise impacted by LCDs: “modestly more pronounced than expected... we saw a mid-single-digit decline year-over-year” in Q1; full-year non-iDose revenues expected down mid-single digits .
  • International FX and competitive trialing headwinds expected to increase through 2025, moderating growth vs 2024’s strong performance .
  • Corneal Health pressured by MDRP: Q1 corneal health $18.5M (+1% YoY) but ongoing realized revenue impact; management guides to flat–low single-digit growth in 2025 .

Financial Results

MetricQ1 2024Q4 2024Q1 2025
Revenue ($USD Millions)$85.6 $105.5 $106.7
GAAP Diluted EPS ($USD)($0.82) ($0.60) ($0.32)
Non-GAAP Diluted EPS ($USD)($0.70) ($0.40) ($0.22)
Gross Margin % (GAAP)~76% ~73% ~77%
Gross Margin % (Non-GAAP)~83% ~82% ~82%
Loss from Operations ($USD Millions, GAAP)($39.1) ($28.7) ($20.7)
Net Loss ($USD Millions, GAAP)($40.8) ($33.6) ($18.1)

Segment breakdown

Segment ($USD Millions)Q4 2024Q1 2025
U.S. Glaucoma$56.3 $59.1
International Glaucoma$27.9 $29.0
Corneal Health$21.4 $18.5
YoY Growth CommentaryU.S. Glaucoma +41% YoY; International +15% (+19% cc); Corneal +1% YoY

KPIs

KPIQ1 2024Q4 2024Q1 2025
SG&A (Non-GAAP, $M)$61.3 $68.6 $70.7
R&D (Non-GAAP, $M)$30.7 $36.5 $32.4
Cash & ST Inv. + Restricted ($M)$323.6 (12/31/24) $303.4 (3/31/25)
CapEx ($M)$1.0 $1.7 $1.9
Weighted Avg. Diluted Shares (M)49.6 55.6 56.6

Estimates comparison (S&P Global)

MetricConsensusActual
Revenue ($USD Millions), Q1 2025$102.8*$106.7
EPS (Non-GAAP, $USD), Q1 2025($0.35)*($0.22)
Values retrieved from S&P Global.*

Narrative: Revenue beat driven by iDose TR adoption and broader glaucoma execution; EPS beat reflects revenue leverage and lower amortization (no IPR&D charge vs prior year) while opex growth remained controlled .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net SalesFY 2025$475–$485M (introduced Q4 2024) $475–$485M (reaffirmed) Maintained
U.S. Non‑iDose RevenuesFY 2025Flat to down low single digits (Q4 call) Down mid‑single digits Lowered
International Glaucoma GrowthFY 2025High single digit (Q4 call) High single‑digit to low double‑digit Slightly Raised
Corneal Health GrowthFY 2025Low single-digit (post MDRP lap) Flat to low single digit Slightly Lowered
OpEx Growth (Non‑GAAP)FY 2025~15% YoY off 2024 base ~15% YoY Maintained
Seasonality for Net SalesFY 2025~23–24% Q2, 24–25% Q3, 28–30% Q4; Q1 ~22% actual New Color

Underlying assumptions include MIGS LCD headwinds, Hydrus royalty expiration on Apr 26, 2025, continued MDRP impact, and FX headwinds; iDose TR ramp and broader IG initiatives expected to offset .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
iDose TR reimbursement & MAC coverageJ-code effective; initial MACs streamlining; 3 MACs adding pro fees Noridian solid; Novitas/First Coast “operating as expected”; Palmetto/WPS paying J-code; working toward consistent pro fees across MACs Improving
U.S. MIGS LCD impactFinal LCDs effective Nov 2024; turbulence anticipated Mid-single-digit YoY decline in stents; full-year non‑iDose down mid‑single digits Headwind persists
International growth & FXStrong 28% YoY; FX headwinds emerging Broad-based growth Q1; guide HSD–LDD amid FX and new competitive trialing Moderating
Corneal Health/MDRPQ4 corneal -2% YoY; MDRP headwind peaked in Q4 Q1 corneal +1% YoY; 2025 guide flat–LSD Stabilizing
R&D execution (Epioxa, PRESERFLO, iDose TREX)NDA submitted; TREX Phase 3 start; PRESERFLO IDE prep FDA accepted Epioxa NDA (PDUFA Oct 20, 2025); PRESERFLO pivotal started; TREX Phase 2b/3 advancing; iDose readministration PAS filed Advancing
Tariffs/macro2025 OPPS/ASC rules steady Minimal direct tariff exposure given U.S.-based sourcing; macro caution embedded in guidance Cautious but insulated

Management Commentary

  • “We are reaffirming our full year 2025 net sales guidance range of $475 million to $485 million…with strong performance driven by iDose TR adoption” — Tom Burns .
  • “Professional fee schedules…Noridian first, and now Novitas and First Coast…we are seeing continued solid and expanding growth” — Joe Gilliam .
  • “We successfully advanced execution of our detailed launch plans for iDose TR…growing number of trained surgeons and accounts…market access among MACs, commercial, and Medicare Advantage payors” — Prepared remarks .
  • “We manufacture and source primarily within the U.S., and as such, expect minimal direct exposure to the most recently implemented tariff-related policies” — Quarterly Summary .

Q&A Highlights

  • U.S. stent headwinds: mid‑single‑digit YoY decline in Q1; guide to non‑iDose down mid‑single digits for 2025 as LCD restrictions persist, offset by stand‑alone iStent infinite .
  • iDose pacing: Q1 implied ~$21M run-rate; momentum supported by MACs turning on pro fees (Noridian, Novitas, First Coast), broadening J-code payment consistency; methodical rollout to commercial/Medicare Advantage .
  • Guidance components: International glaucoma HSD–LDD; corneal health flat–LSD; modestly higher iDose expectations embedded; seasonality skewed to H2 .
  • Readministration & next-gen: iDose PAS filed with 6‑month FDA timeline; TREX advancing as de facto reimplantation path if needed .
  • OpEx: ~15% YoY growth in 2025 off 2024 base; path to margin accretion from iDose volumes by late 2025 .

Estimates Context

  • Q1 2025: Revenue beat ($106.7M vs $102.8M*), non-GAAP EPS beat (($0.22) vs ($0.35)), EBITDA ahead of consensus; strength from iDose ramp and glaucoma execution. Values retrieved from S&P Global.*
  • Near-term expectations: Management indicated Q2 quarter weighting ~23–24% with continued iDose progress and expanding MAC reimbursement .

Where estimates may need to adjust:

  • Raise iDose trajectories modestly given expanding MAC pro fees and consistent J-code payment in more regions .
  • Temper U.S. stent (non‑iDose) revenues to down mid‑single digits for 2025 given LCDs and Hydrus royalty expiration .
  • Moderate international growth for FX and competitive trialing; maintain HSD–LDD .

Key Takeaways for Investors

  • Q1 print demonstrated durable revenue momentum and a clear beat; reaffirmed FY25 guide anchors the iDose-led growth narrative .
  • The iDose reimbursement cadence is improving across MACs; watch for additional professional fee schedules and J-code consistency—key near-term stock catalysts .
  • Expect non‑iDose U.S. stent pressure through 2025 (LCDs, Hydrus royalty expiry), but stand‑alone iStent infinite utilization and combo cataract iDose use should partially offset .
  • International growth normalizing from 2024 highs; FX and competitive trialing warrant conservative models (HSD–LDD) .
  • Corneal health is stabilizing (flat–LSD) ahead of potential Epioxa approval; PDUFA Oct 20, 2025 provides optionality for 2026 growth and portfolio balance .
  • Margin trajectory improving; management targets ~15% OpEx growth and sees iDose manufacturing scaling as the path to margin accretion late 2025 .
  • Tactical: Near term, the stock is likely to trade on iDose reimbursement milestones and monthly utilization trends; medium term, pipeline events (Epioxa, PRESERFLO, TREX) expand optionality and support multiple .

Additional Relevant Press Releases (Q1 2025)

  • FDA acceptance of Epioxa NDA; PDUFA Oct 20, 2025 .
  • Collaboration with RadiusXR and Topcon to expand patient access to vision diagnostics (Inspire platform) .