Glaukos Corporation Q3 FY2025 earnings call

Management Statement and Operational Highlights

• Recorded third quarter consolidated net sales of $133.5 million, a 38% increase on a reported basis or 37% on a constant currency basis compared to the year-ago quarter.
• Raised full-year 2025 net sales guidance to $490 million to $495 million from the prior range of $480 million to $486 million.
• Highlighted the FDA approval of Epioxa, a groundbreaking corneal cross-linking therapy for keratoconus, and discussed the transition from Photrexa to Epioxa, including investments in patient awareness and access.
• Noted the strong commercial momentum of iDose TR, a first-of-its-kind intracameral procedural pharmaceutical for glaucoma, with growing utilization and positive clinical outcomes.
• Broke ground on a new 200,000 square foot research, development, and manufacturing facility in Huntsville, Alabama to support long-term growth and innovation, including Epioxa production.

Segment Performance

• U.S. Glaucoma Franchise: Record third quarter net sales of $80.8 million, up 57% year-over-year. iDose TR generated approximately $40 million in sales during the third quarter.
• International Glaucoma Franchise: Net sales of $29.4 million, up 20% on a reported basis and 17% on a constant currency basis compared to the year-ago quarter.
• Corneal Health Franchise: Net sales of $23.3 million, up 13% year-over-year, with Photrexa net sales totaling $20.3 million.

Guidance

• Raised full-year 2025 net sales guidance to $490 million to $495 million from $480 million to $486 million, reflecting third quarter outperformance and ongoing momentum.
• Introduced a preliminary 2026 revenue guidance range of $600 million to $620 million, factoring in the commercial rollout of iDose TR, Epioxa launch, and performance of the International Glaucoma franchise.
• Plans to refine 2026 guidance and provide more granular details during the fourth quarter 2025 earnings call.

Risks

• Uncertainties surrounding payer coverage and reimbursement for iDose TR and Epioxa, which could impact market access and adoption.
• Challenges in expanding patient access for keratoconus treatments despite Epioxa approval, including hurdles related to awareness, diagnosis, and reimbursement.
• Regulatory and macroeconomic factors, such as foreign currency fluctuations, that may affect business operations and financial results.

Question and Answer

• Q: About the iDose CAC meeting and potential outcomes.

A: Discussed educating Medicare Administrative Contractors (MACs) on iDose's evidence, data, and its role in changing glaucoma treatment paradigms, with various paths for reimbursement adjudication possible.

• Q: On Epioxa pricing, coverage, and 2026 Corneal Health.

A: Expressed confidence in executing with Epioxa pricing through payer education efforts, and noted 2026 involves Epioxa ramping up and Photrexa transitioning off, with initial challenges expected in patient access.

• Q: On iDose performance, ramp, and mix of standalone vs. combo cataract.

A: Talked about iDose's growth, the impact of NGS (National Government Services) on ramp, and the mix of standalone vs. combo cataract utilization being surgeon-specific with some incremental growth in combo settings.

• Q: On Epioxa execution, payer coverage, and capital equipment.

A: Discussed payer education efforts for Epioxa coverage, options for customers to acquire, lease, or swap out capital equipment for Epioxa, and ongoing work to establish the site of care network.

• Q: On iDose reapplications and the CAC meeting.

A: Mentioned the PDUFA date for iDose reapplications is January 28, 2026, and ongoing FDA discussions, with optimism about favorable outcomes and the importance of reimplantation considerations.