Glaukos Corp. Reports Record Sales and FDA Approval

Glaukos Corp. ((GKOS)) has held its Q3 earnings call. Read on for the main highlights of the call.

Glaukos Corp. recently held its earnings call, revealing a strong financial performance marked by record sales and significant product approvals. The sentiment was generally positive, with the FDA approval of Epioxa being a notable highlight. However, challenges remain, particularly in transitioning the Corneal Health franchise and establishing market access for new products.

Record Third Quarter Sales

Glaukos reported record third quarter consolidated net sales of $133.5 million, representing a 38% increase on a reported basis and 37% on a constant currency basis compared to the previous year. This impressive growth underscores the company’s robust market performance and strategic execution.

iDose TR Adoption

The U.S. Glaucoma franchise achieved record third quarter net sales of $80.8 million, with iDose TR contributing approximately $40 million. This strong adoption highlights the product’s market acceptance and its role in driving the company’s sales growth.

Epioxa FDA Approval

A significant milestone for Glaukos was the FDA approval of Epioxa for corneal cross-linking for keratoconus. This approval marks Epioxa as the first and only FDA-approved topical drug therapy that does not require the removal of the corneal epithelium, setting a new standard in treatment.

Raised Full-Year 2025 Guidance

Glaukos raised its full-year 2025 net sales guidance to a range of $490 million to $495 million, up from the previous range of $480 million to $486 million. This adjustment reflects the company’s confidence in its growth trajectory and market opportunities.

Strong International Growth

The International Glaucoma franchise reported net sales of $29.4 million, marking a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis. This growth indicates Glaukos’s expanding global footprint and successful international strategies.

Corneal Health Franchise Transition

The transition from Photrexa to Epioxa may lead to a material year-over-year decline in the fourth quarter for the Corneal Health franchise. This transition poses a challenge as the company navigates changes in its product lineup.

Reimbursement and Market Access Challenges

Glaukos faces challenges in establishing professional fees in some MAC regions and requires extensive payer education for Epioxa. These hurdles could impact the company’s ability to secure market access and reimbursement.

Epioxa Pricing Concerns

The wholesale acquisition cost for Epioxa is set at $78,500, which may pose challenges in payer coverage and patient access. Pricing strategies will be crucial in ensuring the product’s market success.

Forward-Looking Guidance

Glaukos has raised its full-year 2025 net sales guidance to between $490 million and $495 million, reflecting strong third-quarter performance and the anticipated launch of Epioxa. The company also introduced a preliminary 2026 revenue guidance range of $600 million to $620 million, driven by ongoing momentum and strategic product launches.

In summary, Glaukos Corp.’s earnings call highlighted a strong financial performance with record sales and strategic product approvals. While the sentiment was positive, challenges remain in transitioning product lines and establishing market access. The company’s forward-looking guidance suggests confidence in continued growth and market expansion.