Glaukos (GKOS) Q1 FY26 earnings call: guidance and Q&A

How are initial experiences with Epioxa's claims and prior authorization processes going, and what does early demand look like based on the patient portal?

The claims process is slower due to the miscellaneous J-code, but the company is encouraged by patient flow into the portal and positive claims adjudication. The site of care network and payer pathways are foundational, and the funnel of clinical demand is developing positively.

“But I will say that we've been very encouraged by those sites of care who come online, as Tom referenced. And the patient flow that's coming from that and into our portal in the hub, as you say, as a leading indicator of what it can mean for the clinical demand associated with an Epi-On therapy like Epioxa.”

asked by Thomas Stephan · answered by Joseph Gilliam

What are the drivers of iDose's strong performance, and how do Noridian/Novitas compare to other MACs in terms of volume?

iDose strength was broad-based, with continued expansion in established MACs (Noridian, Novitas, First Coast) and early signs of adoption in NGS and Palmetto. Commercial and Medicare Advantage patient flow also increased. Established MACs accounted for 73% of overall regional volumes in Q1, down from 78% in Q4, indicating growth in newer MACs.

“But now you start to see NGS in particular, turning on the early signs of Palmetto turning on as well as we've more recently achieved a professional fee formally in that region. And I think also is encouraging was a real increase certainly in the funnel into our hub associated with commercial and Medicare Advantage patient flow.”

asked by Thomas Stephan · answered by Joseph Gilliam

With critical mass in iDose reimbursement, what new initiatives are planned, such as growing the commercial team or direct-to-consumer marketing?

The company plans to drive increased awareness for iDose and interventional glaucoma through education for patients and providers. Significant investments are being made in reimbursement and business teams to maximize patient access. More offensive investments, including DTC, will be considered in the second half of the year as confidence in the reimbursement foundation grows.

“So we have been making significant investments for some time now in more of our reimbursement and business teams that surround the traditional sales force to really try to make sure that we can maximize both patient access and that broader awareness initiative.”

asked by Adam Maeder · answered by Joseph Gilliam

How has engagement with MACs progressed since the CAC meeting, and what are the updated thoughts on the likelihood and timing of an LCD this year?

Engagement with MACs continues through education on technology and utilization. Momentum is seen in conversations with CGS and WPS to establish professional fees. No signs of an LCD have been observed, and it is believed to be premature at this stage of clinical adoption, though unpredictable.

“At this point, we've not seen any signs of an LCD, and we continue to believe it would be premature at this stage of the clinical adoption curve. And having said that, obviously, by nature, these things could be unpredictable and opaque.”

asked by Larry Biegelsen · answered by Joseph Gilliam

How confident is the company in Epioxa returning to peak Photrexa levels (18,000-19,000 eyes) by the end of the decade, and what does the ramp look like?

The company views Epioxa as a potential $1 billion-plus franchise and aims to treat far more than peak Photrexa volumes. Investments in awareness and detection are intended to grow the overall market volume. Future generations of customized algorithms for keratoconus are expected to further expand the market beyond the current planning period.

“I think we have been on record of saying we view this as a potential $1 billion-plus franchise and the pace in which we get there, we'll continue to monitor as we get into the actual true commercialization, especially as we get towards the second half of this year.”

asked by Larry Biegelsen · answered by Joseph Gilliam

How does the company view operating expense guidance and the timeline to profitability, especially with Epioxa commercialization?

The company's near-term focus is cash flow breakeven and operating leverage. There is a clear line of sight to profitability in the next few years, dependent on commercial launch ramps. Operating expenses are expected to grow in the high teens for the year, slightly up from initial plans due to Q1 overachievement, reflecting reinvestment in commercial launches while maintaining operating leverage.

“So you should see the operating expenses tick up slightly and modestly from what we talked about at the beginning of the year, but still in the high teens and still showing that operating leverage overall as we progress throughout the year.”

asked by Ryan Zimmerman · answered by Alex Thurman

Given the strong Q1 performance in core U.S. Glaucoma, why is the forecast for flat sales in Q2 and for the full year? Is it conservatism or real challenges?

The strong performance in Q1 and Q4 FY25 indicates stabilization and restoration of growth in the non-iDose U.S. Glaucoma market. However, the company is not yet ready to call this the 'new normal' and maintains a conservative 'flat' outlook until sustained performance is proven. Some Q1 benefit from competitor supply chain disruptions is noted, which is expected to subside.

“I think it's still safer for us and for investor expectations to be in that sort of more, I'll call it, flat year-over-year basis until we've proven otherwise on a sustained basis.”

asked by K. Gong · answered by Joseph Gilliam

What is the true TAM for keratoconus patients in the U.S., and what is the diagnostic pathway to increase patient funnel?

The company believes the current 18,000-20,000 eyes treated annually is a fraction of the true potential. Estimates suggest 50,000-100,000 keratoconus eyes per year should be diagnosed and treated. Investments in awareness and detection initiatives are aimed at growing the overall market, believing it is more a 'rarely diagnosed' than a 'rare disease'.

“I think our best estimates here suggest that there should be between 50,000 and 100,000 keratoconus eyes a year at a minimum that are getting diagnosed and treated with Epioxa cross-linking.”

asked by Anthony Petrone · answered by Joseph Gilliam