GLAUKOS Corp Q4 FY2024 earnings call

Management Statement and Operational Highlights

• Financial Results: Fourth quarter consolidated net sales reached $105.5 million (up 28% YOY), and full-year 2024 consolidated net sales were $383.5 million (up 22% YOY). 2025 net sales guidance is $475 million to $485 million.
• iDose TR: Celebrated 1-year anniversary of controlled launch, with strong fourth quarter sales, positive clinical outcomes, and growing clinical literature. Progress in reimbursement with 5 of 7 MACs processing the J-code and 3 MACs having professional fee schedules.
• International Operations: Demonstrated strong growth in 2024 but faces challenges in 2025 from FX headwinds, competitive product trialing, and the expiration of a French rebate tailwind.
• Pipeline and Development: NDA submission of Epioxa for keratoconus, plans for Phase 2 trials of iLution Blepharitis and U.S. IDE trial for PRESERFLO MicroShunt in 2025, and progress on a new R&D facility in Huntsville, Alabama.

Segment Performance

• U.S. Glaucoma Franchise: Record fourth quarter net sales of $56.3 million, representing a 45% year-over-year increase, driven primarily by growth from iDose TR.
• International Glaucoma Franchise: Record net sales of $27.9 million, with year-over-year growth of 28% (29% on constant currency basis), reflecting broad-based growth but facing headwinds in 2025 from foreign currency fluctuations, competitive product trialing, and the sunsetting of a French rebate tailwind.
• Corneal Health Franchise: Delivered net sales of $21.4 million, including $18.8 million from Photrexa, impacted by the company's entry into the Medicaid Drug Rebate Program, but with progress on the NDA submission of Epioxa for keratoconus and ongoing pipeline development for cross-linking therapies.

Guidance

• 2025 Net Sales: Management provides a guidance range of $475 million to $485 million.
• U.S. Glaucoma: iDose growth offsets headwinds from LCDs and Hydrus royalty expiration, with non-iDose revenues expected to be flat to low single-digit growth.
• International Glaucoma: Anticipates high single-digit growth, impacted by FX, competitive product trialing, and the expiration of a French rebate tailwind, but with potential upside from MDR approval for iStent Infinite in Europe.

Risks

• Regulatory: Uncertainty around FDA approval for re-administration of iDose, with a post-approval supplement expected to be submitted in the first half of 2025.
• Macroeconomic: Foreign currency fluctuations impacting international financial results.
• Competitive: Potential trialing of competitive products in major international markets.
• Reimbursement: Volatility in MAC coverage and payment for iDose, with ongoing efforts to establish consistent reimbursement.

Question and Answer

• Q: Elaborate on iDose trends and year-to-date performance A: Joe Gilliam discussed iDose TR revenues doubling quarter-over-quarter, growing clinical evidence, expanding trained surgeons, and progress in reimbursement with 5 MACs processing the J-code.
• Q: Components of 2025 revenue guidance A: Joe Gilliam explained iDose growth offsetting headwinds from LCDs and Hydrus royalty expiration, with non-iDose revenues expected flat to low single-digit growth.
• Q: iDose sales potential vs. implantable MIGS procedures A: Joe Gilliam stated iDose could surpass implantable MIGS procedures over the medium to long term, targeting a larger market of glaucoma and ocular hypertension patients.
• Q: iDose re-administration status A: Tom Burns mentioned negotiation with the FDA for a post-approval supplement, expecting submission in the first half of 2025 and a decision by the end of 2025.
• Q: International glaucoma growth outlook A: Joe Gilliam discussed high single-digit growth expected, impacted by FX, competitive product trialing, and the expiration of a French rebate tailwind, with MDR approval for iStent Infinite in Europe as a potential upside.