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GLAUKOS Corp (GKOS)·Q3 2025 Earnings Summary

Executive Summary

  • Record Q3 revenue and raised outlook: Net sales $133.5M (+38% y/y, +7.6% q/q), with non-GAAP gross margin ~84%; FY25 revenue guidance raised to $490–$495M and preliminary FY26 guide introduced at $600–$620M .
  • iDose TR momentum: U.S. Glaucoma revenue hit a record $80.8M (+57% y/y) with iDose TR contributing ~$40M; management framed iDose as creating a new category and highlighted expanding MAC coverage and pending CAC discussions .
  • Epioxa approved and priced: FDA approved Epioxa (epi-on cross-linking) with wholesale acquisition cost of $78,500; commercial launch targeted for Q1’26 with staged transition away from Photrexa; management emphasized access programs and payer education .
  • Beat vs S&P Global consensus: Revenue $133.5M vs $122.5M consensus; non-GAAP EPS ($0.16) vs ($0.26) consensus; strong top-line beat driven by iDose TR adoption and broader IG initiatives; see Estimates Context section (S&P Global) .
  • Key stock catalysts: iDose TR reimbursement trajectory (CAC/LCD outcomes), early Epioxa launch execution and payer coverage, FY26 growth path across glaucoma and corneal franchises, and iDose TR re-administration PDUFA (Jan 28, 2026) .

What Went Well and What Went Wrong

  • What Went Well

    • Strong growth and guidance raise: Q3 net sales +38% y/y to $133.5M; FY25 revenue guide raised to $490–$495M; preliminary FY26 $600–$620M introduced .
    • iDose TR traction: U.S. Glaucoma $80.8M (+57% y/y) supported by ~$40M iDose TR sales; “we are pioneering a brand new therapeutic category that has the potential to reshape glaucoma management” (Tom Burns) .
    • Epioxa FDA approval: First incision-free topical therapy for keratoconus; launch planned Q1’26 with robust access and awareness investments; management calls it a “reset moment” for keratoconus care .
  • What Went Wrong

    • Corneal Health near-term headwinds: Q4 guide commentary implies a “fairly material” y/y decline as business transitions from Photrexa to Epioxa; early signs of patients deferring Photrexa post-approval .
    • International glaucoma and U.S. stent dynamics: International facing competitive trialing in key markets; U.S. stent business stabilizing but expected low single-digit decline in Q4 on tougher comps and LCD impacts .
    • Non-GAAP add-backs notable: Non-GAAP margin relies on recurring amortization (Avedro/Mobius) and a non-recurring inventory write-down ($1.3M) in Q3; investors should account for differential vs GAAP .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($M)$96.7 $124.1 $133.5
Gross Margin (GAAP)76.6% 78.3% 78.4%
Gross Margin (Non-GAAP)82.4% 83.0% 83.9%
Diluted EPS (GAAP)($0.39) ($0.34) ($0.28)
Diluted EPS (Non-GAAP)($0.28) ($0.24) ($0.16)

Notes on adjustments: Non-GAAP gross margin excludes amortization of developed technology (Avedro) ~$5.5M, Mobius IP amortization, and a non-recurring inventory write-down of ~$1.3M in Q3 2025 .

Segment breakdown (sales, $M)

SegmentQ1 2025Q2 2025Q3 2025
U.S. Glaucoma$59.1 $72.3 $80.8
International Glaucoma$29.009 $31.251 $29.443
Corneal Health$23.3
Glaucoma Total$88.1 $103.5 $110.2

KPIs and other metrics

KPIQ3 2025
iDose TR Sales (approx.)~$40.0M
Cash, ST investments & restricted cash~$277.5M; no debt
Capital Expenditures~$1.6M
Non-GAAP Operating Loss($9.3)M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Sales (Revenue)FY 2025$480–$486M (as of Q2’25) $490–$495M Raised
Net Sales (Revenue)FY 2026$600–$620M (preliminary) Introduced

Management also flagged Q4 dynamics: mid-40% y/y growth for U.S. glaucoma; low double-digit growth for International; “fairly material” y/y decline for Corneal Health during the Photrexa→Epioxa transition; iDose TR growth continues but tempered sequentially given surgeon schedules and timing of NGS professional-fee tailwind .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
iDose TR adoption & reimbursementScaling adoption with FY25 guide increases; strong U.S. glaucoma growth in Q1/Q2 press releases ~$40M iDose TR sales; 70% of Medicare lives with professional fees incl. NGS; CAC/LCD education underway Accelerating adoption; reimbursement advancing; policy overhang in focus
Epioxa (epi-on CXL)Not approved yet in Q1/Q2 FDA approval; WAC $78,500; Q1’26 launch; access/awareness build; staged Photrexa discontinuation Major new growth vector; near-term corneal headwind as transition begins
Regulatory & policyFY25 guide framework included LCD/MAC considerations (implied); MIGS LCDs impacted U.S. stents earlier in year CAC on iDose TR; LCD coverage vs payment nuance; re-administration PDUFA 1/28/26; EU MDR iStent infinite launch in EU Policy path clearer but still key variable
International glaucomaGrowth with competitive dynamics emerging +20% y/y in Q3; notes of competitive trialing headwinds in 2025 Solid but moderating vs competitive backdrop
Tariffs & supply chainNot highlightedMinimal direct tariff exposure given U.S. manufacturing/sourcing Low direct risk currently
R&D executionPipeline advancing across glaucoma/corneal/retina Broad pipeline updates; iDose TREX ph2b/3, iStent infinite trials, Retina XR FIH; Huntsville facility groundbreaking Sustained investment and milestones ahead

Management Commentary

  • “Record third quarter consolidated net sales of $133.5 million… We are raising our full year 2025 net sales guidance… Our results… driven by growing iDose TR adoption and utilization, along with broader IG initiatives globally.” – Tom Burns .
  • “We have established a wholesale acquisition cost for Epioxa of $78,500… unique as a single administration therapy… we anticipate Epioxa will be commercially available in the first quarter of 2026 under a miscellaneous J code…” – Management .
  • “PDUFA date… January 28, 2026… we are hopeful, but we’re not counting on the FDA giving us the nod to move forward with re-administration.” – Management on iDose TR re-administration .
  • “We commenced commercial launch activities for iStent infinite in our key European markets at the ESCRS… interest levels… very high.” – Management .
  • “We expect minimal direct exposure to the most recently implemented tariff-related policies… we manufacture and source primarily within the U.S.” – Company quarterly summary .

Note: The transcript references “Votrexa,” which corresponds to Photrexa in the press materials .

Q&A Highlights

  • iDose TR reimbursement/CAC: Management views the CAC process as education to support appropriate coverage; highlighted robust clinical evidence and growing MAC coverage; LCDs affect coverage while separate work continues on payment levels .
  • Epioxa pricing and access: WAC $78,500; management expects a phased access ramp in 2026 (miscellaneous code 1H26, J-code by July 2026), with significant investments in payer education, patient support, and site-of-care buildout .
  • iDose TR ramp shape: Early-phase trajectory described as “pretty solid linear”; potential for broader utilization as reimbursement stabilizes; NGS effect to show later .
  • 2026 guide composition: Company deferred franchise splits to Q4 call but indicated multiple paths across U.S./International Glaucoma and corneal health to achieve $600–$620M .
  • Clinical timelines: Level 1 studies (iDose + cataract vs cataract alone; iDose + iStent infinite vs infinite alone) enrolling; potential readouts late 2026 to 2027 .

Estimates Context

Results vs S&P Global Wall Street consensus (Q3 2025):

MetricActualConsensusSurprise
Revenue ($M)$133.537 $122.548*+$10.989M
Adj. EPS (Non-GAAP)($0.16) ($0.259)*+$0.10

Values marked with * are retrieved from S&P Global.
S&P Global consensus inputs: 15 estimates for revenue and EPS; GetEstimates shows consensus means and actuals aligned to reported quarter.

Implications: Significant top-line beat driven by iDose TR adoption and broader IG execution; non-GAAP EPS beat benefited from scale, gross margin accretion and controlled opex while still investing in commercial and R&D .

Key Takeaways for Investors

  • Glaucoma engine accelerating: iDose TR delivered ~$40M in Q3 with expanding MAC coverage; U.S. Glaucoma up 57% y/y; continued momentum into 2026 underpins raised FY25 and new FY26 guides .
  • Epioxa transforms corneal franchise: FDA approval with premium WAC and Q1’26 launch should reset growth trajectory, but near-term (Q4) corneal headwinds as patients/providers await Epioxa; watch payer coverage cadence and J-code timing .
  • Policy/reimbursement is the swing factor: CAC/LCD outcomes and professional fee progression can drive utilization mix and uptake for iDose TR; management expects more stability over time .
  • Non-GAAP vs GAAP quality: Non-GAAP margins exclude sizable amortization and a one-time inventory write-down; track GAAP-to-Non-GAAP reconciliation as scale improves .
  • 2026 road map credible but execution-heavy: Multiple levers (iDose TR, EU iStent infinite, Epioxa) support $600–$620M target; execution on site-of-care buildout, payer education, and regulatory milestones is critical .
  • Watch clinical catalysts: iDose TR re-administration PDUFA (Jan 28, 2026) and Level 1 combo studies (late 2026–2027) could expand labels/usage and support longer-term penetration .
  • International competitiveness: Good base but monitor competitive trialing impacts in key markets; balanced expectations set by management .

Appendix: Additional Data and Disclosures

  • Balance sheet strength: ~$277.5M in cash/ST investments/restricted cash; no debt at quarter end .
  • Sequential trends: Total net sales +16.4% q/q in Q2 and +7.6% q/q in Q3; international glaucoma declined q/q in Q3 due to mix/competitive dynamics .
  • Non-GAAP reconciliation references: Detailed add-backs include Avedro/Mobius intangible amortization and one-time inventory write-down; see press release and 8-K exhibits .

References

  • Q3 2025 8-K and exhibits (press release and quarterly summary): .
  • Q3 2025 press release (Business Wire): .
  • Q3 2025 earnings call transcript: .
  • Epioxa FDA approval press release: .
  • Prior quarters press releases for trend analysis: Q2 2025 ; Q1 2025 .

S&P Global Consensus Disclaimer

  • Asterisked values in Estimates Context are retrieved from S&P Global via GetEstimates.