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
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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 .
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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
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)
KPIs and other metrics
Guidance Changes
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
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):
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.