GKOS Q2 2025: iDose Drives $124M Sales; FY Guidance to $486M
- Strong iDose Momentum: Management highlighted that over 80% of iDose sales in Q2 originated from regions with fully established professional fee schedules—indicating robust physician adoption and increasing utilization that could drive further growth in key Medicare and commercial segments.
- Pipeline Catalysts and Regulatory Milestones: The near-term potential from the upcoming FDA decision on iDose reimplantation (targeted for early 2026) and the planned clinical trial for the enhanced iDose Trio product supports expanding the addressable market, including a shift toward in-office procedures with higher margin potential.
- Margin Accretion and Operational Discipline: With gross margins around 83% and disciplined investments driving cash flow improvements (evidenced by raised full-year guidance and positive underlying cash generation in Q2), Glaukos is well-positioned for sustained profitability and growth.
- Regulatory & Clinical Uncertainty: The FDA’s reclassification of the iDose reimplantation petition as an NDA supplement—with a PDUFA date now set to 01/28/2026—underscores the uncertainty of a positive outcome. Management explicitly noted they are “not at all counting on a positive outcome” for reimplantation, highlighting a significant regulatory risk.
- Reimbursement and Pricing Headwinds: Ongoing challenges in establishing consistent professional fee schedules across all MAC regions—especially in areas like Palmetto, WPS, and CGS, where progress is slower—suggest potential revenue and margin pressures. Declining fees and headwinds from legacy MIGS procedures (e.g., iStent business facing high single-digit declines) add to the risk.
- Transitional Revenue Disruption: The transition from Photrexa to Epioxa in the corneal health franchise may lead to near-term revenue and market share disruptions, as patients and sites adjust to the new treatment and the rollout of the new cross-linking machine, creating execution uncertainty and potential short-term financial impact.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Full-Year 2025 Net Sales Guidance | FY 2025 | $475 million to $485 million | $480 million to $486 million | raised |
Corneal Health Business | FY 2025 | flat to low single-digit growth | no current guidance | no current guidance |
International Glaucoma | FY 2025 | revised expectations to high single-digit to low double-digit growth | no current guidance | no current guidance |
U.S. Glaucoma (Non-iDose Revenues) | FY 2025 | anticipated mid-single-digit decline | no current guidance | no current guidance |
iDose Franchise | FY 2025 | modestly increased expectations | no current guidance | no current guidance |
Full-Year 2025 OpEx | FY 2025 | no prior guidance | approximately $460 million with mid‑teens growth | no prior guidance |
Full-Year 2025 Gross Margin | FY 2025 | no prior guidance | 82% to 84% | no prior guidance |
Full-Year 2025 Cash Flow | FY 2025 | no prior guidance | targeting cash flow breakeven or small cash generation | no prior guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
iDose Adoption and Growth | Discussed in Q3 2024 with strong uptake and doubling sales , in Q4 2024 with record U.S. glaucoma franchise sales driven by iDose TR , and in Q1 2025 with robust revenue contribution and momentum in adoption | Q2 2025 highlighted record U.S. glaucoma franchise sales with iDose TR generating $31 million and strong clinical feedback amid ongoing reimbursement challenges | Consistently strong performance with expanding adoption and revenue, with ongoing efforts to address reimbursement challenges. |
Reimbursement Dynamics and Professional Fee Schedule | Q3 2024 addressed MAC adjudication and progress toward normalized J-code and professional fee payments ; Q4 2024 noted streamlined processing in most MACs ; Q1 2025 detailed progress with Noridian and other MACs plus continued challenges | Q2 2025 acknowledged ongoing turbulence related to LCDs and professional fee challenges, with progress on J-code processing and targeted advocacy efforts | Ongoing progress with familiarity and slight improvement in standardized reimbursement even as challenges persist. |
Regulatory and Clinical Milestones | Q3 2024 discussed discussions on reimplantation and NDA supplement approaches ; Q4 2024 mentioned submission plans and anticipated PDUFA timelines ; Q1 2025 provided updates on the iDose reimplantation supplement and Epioxa NDA acceptance | Q2 2025 updated milestones with an FDA PDUFA date for iDose reimplantation (January 28, 2026), completed Epioxa pre-approval milestones, and adjusted timelines for iDose Trio approval (targeted end of 2027) | Consistent regulatory activity with evolving timelines, reflecting both maturity in submission processes and new testing requirements. |
Pipeline Innovation and New Product Development | Q3 2024 featured positive signals on iDose TR, integration with iStent Infinite, and initiation of Phase I trials for Axitinib in wet AMD ; Q4 2024 emphasized iDose Trio’s modifications and integration updates ; Q1 2025 focused on iDose TR performance and combination therapy evidence | Q2 2025 introduced the development of iDose Trio with enhanced applicator design, emphasized ongoing integration with iStent Infinite in pivotal trials, and advanced first-in-human work on Axitinib for wet AMD | Continued emphasis on pipeline innovation, exemplified by new product developments and integration strategies to enhance glaucoma care. |
Margin Performance and Operational Efficiency | Q3 2024 reported robust gross margins (82–83%) that were partially offset by manufacturing inefficiencies related to the iDose launch | Q2 2025 did not mention margin performance or operational efficiency | A notable topic in Q3 2024 that is currently less emphasized, indicating a possible shift in focus from short‐term manufacturing issues. |
International Market Dynamics and Competitive Pressures | Q3 2024 cited international sales growth (e.g. $24.5 million with 21% growth) and favorable regulatory setups (e.g. French CEPS) ; Q4 2024 noted record international sales with FX headwinds and competitive product trialing ; Q1 2025 described record international franchise performance and discussed forex and competitive headwinds | Q2 2025 reported record international glaucoma franchise sales ($31.3 million), highlighted EU MDR clearance for iStent Infinite, and acknowledged forex challenges plus emerging competitive pressures | Consistent growth internationally despite forex headwinds and competitive pressures, with potential upside from European approvals. |
Legacy Glaucoma Business Challenges | Q3 2024 mentioned transient turbulence in the stent business due to LCD adjustments ; Q4 2024 detailed mid-single digit declines in non-iDose stent sales and the Hydrus royalty headwind ; Q1 2025 reported mid-single digit declines from LCD restrictions and Hydrus royalty expiration impacts | Q2 2025 outlined continued challenges: LCD restrictions causing market turbulence, anticipated stent business declines, and impacts from the expired Hydrus royalty | Persistent headwinds in the legacy business with similar patterns of LCD restrictions and royalty expiration issues continuing into the current period. |
Macroeconomic and Tariff Headwinds | Q1 2025 described potential macroeconomic slowdown and limited tariff exposure due to U.S.-based manufacturing ; Q4 2024 mentioned FX headwinds and competitive product launches | Q2 2025 did not mention macroeconomic or tariff headwinds | A shift away from discussing these external factors in the current period, suggesting they are less emphasized now. |
Corneal Health Franchise Transition | Q3 2024 highlighted the impact of Photrexa revenue pressures due to the Medicaid Drug Rebate Program and presented promising Phase III outcomes for Epioxa ; Q4 2024 discussed Photrexa headwinds and an expected Epioxa NDA with a launch in 2026 ; Q1 2025 mentioned Photrexa revenue impact and FDA acceptance for Epioxa NDA to optimize patient access | Q2 2025 noted anticipated revenue disruption as patients defer Photrexa in favor of Epioxa pending its expected October approval, indicating temporary warehousing of patients | Consistent focus on the transition from Photrexa to Epioxa, with current period emphasizing near-term revenue disruption before eventual commercial upside. |
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Revenue Guidance
Q: What drove raised full year guidance?
A: Management pointed to record Q2 net sales of $124M driven largely by strong iDose performance, which underpinned the raise of full-year guidance to $480–486M, despite some market headwinds. -
Interventional Opportunity
Q: Why is the interventional glaucoma market attractive?
A: Leaders emphasized that the growing adoption of procedures like iDose and iStent Infinite signals entry into a transformative market—with millions of patients possibly needing proactive interventions—and expects long-term significant growth. -
iDose Reimplantation & Trio
Q: What are iDose reimplantation and Trio timelines?
A: Management noted that the FDA has classified the reimplantation petition as an NDA supplement, setting a PDUFA date of 01/28/2026, while enhanced iDose Trio trials are slated to start by year’s end with approval targeted by end 2027. -
MAC Adoption for iDose
Q: Will all MACs pay the proper iDose code?
A: Management explained that most MACs are now paying the proper J code with established professional fees, and efforts continue with the few laggards to achieve uniform reimbursement across regions. -
Epioxa Rollout
Q: Is the new Epioxa cross-linking machine a trade-in?
A: They clarified it will be a new purchase with a phased rollout starting in Q4, as practices transition from Photrexa to Epioxa, expecting some patient warehousing until sites are fully ready. -
iDose and EVRIOXA Guidance
Q: What are the outlooks for iDose and EVRIOXA?
A: Guidance was raised based on robust iDose adoption in regions with strong pro fee schedules, and while there’s anticipation for EVRIOXA following approval, no formal wait list exists yet as discussions with payers continue. -
Reimbursement & SG&A
Q: How will fee changes impact margins and SG&A?
A: Management noted that proposed facility fee uplifts largely offset lower physician fees, and although SG&A increased partly due to a $4M stock comp hit, underlying growth remains in the mid-teens, supporting stable margins. -
Regional Utilization
Q: Are MAC regions showing different utilization?
A: It was highlighted that regions with long-established professional fees—like those served by Novitas, Meridian, and First Coast—contributed over 80% of iDose volumes, reflecting faster physician adoption and deeper utilization compared to others. -
iStent Performance & Cash Flow
Q: What trends are expected for US iStent and cash flow?
A: Despite a near 10% decline in the legacy iStent business due to transitional headwinds, management expects the drop to moderate, while underlying cash generation improved after factoring in onetime investments such as the building purchase and acquisition. -
iDose Margin Accretion
Q: When will iDose boost overall margins?
A: The high-margin nature of iDose, already contributing to a gross margin around 83%, is expected to gradually accrete to overall corporate margins as volume grows and reimbursement becomes more favorable. -
Managed Care Coverage
Q: Is managed care starting to cover iDose?
A: Early signs indicate that while many managed care policies remain silent, positive shifts are emerging as early adopters expand into commercial and Medicare Advantage segments, supporting future growth. -
Physician Choice
Q: How do docs choose iDose versus iStent?
A: Physicians are adopting iDose as a foundational therapy for glaucoma, turning to iStent or iStent Infinite for more advanced cases, creating a complementary treatment pathway that supports long-term patient management.
Research analysts covering GLAUKOS.