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01/11 08:26
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents strong financial performance with significant growth in key franchises, a robust balance sheet, and positive guidance. The Q&A highlights confidence in iDose and Epioxa, despite some uncertainties in payer coverage and FDA decisions. The raised guidance and promising pipeline developments further support a positive sentiment. However, some caution is warranted due to potential market headwinds and unclear responses in the Q&A.
Consolidated Net Sales $133.5 million, up 38% on a reported basis or 37% on a constant currency basis year-over-year. The growth was driven by growing iDose TR adoption and utilization, along with broader Interventional Glaucoma initiatives globally.
U.S. Glaucoma Franchise Net Sales $80.8 million, a year-over-year growth of 57%. This was driven by growing contributions from iDose TR, which generated sales of approximately $40 million in the third quarter.
International Glaucoma Franchise Net Sales $29.4 million, a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis. The growth was broad-based as the company scaled its international infrastructure and executed plans to drive MIGS forward as the standard of care globally.
Corneal Health Franchise Net Sales $23.3 million, a year-over-year growth of 13%, including Photrexa net sales of $20.3 million. The growth reflects the continued impact of Photrexa realized revenues as a result of the company's entry into the Medicaid Drug Rebate Program.
Gross Margin Continued gross margin accretion was observed, though specific figures were not provided. This reflects strong execution against strategic priorities and operational efficiency.
Cash and Debt $278 million in cash and no debt, indicating a strong balance sheet.
Epioxa Approval: FDA approved Epioxa, a groundbreaking advancement in corneal cross-linking for keratoconus treatment. It is the first and only FDA-approved topical drug therapy that does not require removal of the corneal epithelium.
iDose TR: iDose TR, a first-of-its-kind intracameral pharmaceutical for glaucoma, generated $40 million in Q3 sales and is gaining commercial momentum.
International Glaucoma Franchise: Net sales of $29.4 million, with 20% year-over-year growth. Commercial launch activities for iStent infinite commenced in key European markets.
Revenue Growth: Record Q3 consolidated net sales of $133.5 million, up 38% year-over-year. Full-year 2025 revenue guidance raised to $490-$495 million.
Operational Efficiency: Gross margin accretion and a strong balance sheet with $278 million in cash and no debt.
Transition to Epioxa: Photrexa will be discontinued in 2026, transitioning to Epioxa as the primary treatment for keratoconus.
New Facility: Groundbreaking of a 200,000 square foot research, development, and manufacturing facility in Huntsville, Alabama.
Regulatory hurdles: The company faces challenges related to regulatory approvals and compliance, as evidenced by the detailed discussion of FDA approvals and the transition from Photrexa to Epioxa. These processes are time-consuming and resource-intensive, potentially delaying product launches and impacting revenue.
Market adoption and patient access: Despite the approval of Epioxa, the company acknowledges significant barriers to patient access, including underdiagnosis, misdiagnosis, and reimbursement hurdles. These factors could limit the adoption of new therapies and affect revenue growth.
Competitive pressures: The company operates in a competitive market, particularly in the glaucoma and corneal health segments. The need to maintain and grow market share while introducing new products like Epioxa and iDose TR adds pressure.
Economic uncertainties: Macroeconomic conditions, including foreign currency fluctuations, could impact the company's financial performance and operational costs.
Supply chain and operational risks: The company is investing in a new manufacturing facility, which introduces risks related to construction delays, cost overruns, and operational inefficiencies during the transition.
Strategic execution risks: The transition from Photrexa to Epioxa involves significant strategic and operational changes, including patient education, awareness campaigns, and the establishment of new care networks. Any missteps could impact the success of Epioxa's launch and overall strategic objectives.
Revenue Guidance for 2025: The company has raised its full-year 2025 net sales guidance range to $490 million to $495 million, up from the previous range of $480 million to $486 million.
Preliminary Revenue Guidance for 2026: The company has introduced a preliminary 2026 revenue guidance range of $600 million to $620 million, factoring in expectations for the continued commercial rollout of iDose TR, the surgical MIGS landscape, the International Glaucoma franchise, and the Corneal Health franchise with the launch of Epioxa.
Epioxa Launch and Transition: Epioxa, a new treatment for keratoconus, is expected to be commercially available in Q1 2026, with a permanent J-code established by July 2026. The company plans to discontinue Photrexa commercial availability following a staged transition process in 2026, prioritizing Epioxa as the primary treatment option.
Investment in Patient Access and Awareness: The company plans to substantially increase investments in patient awareness and access for keratoconus treatment, including enhanced education campaigns, development of a handheld KC screening device, and expanded advocacy partnerships.
Infrastructure Expansion: The company has broken ground on a new 200,000 square foot research, development, and manufacturing facility in Huntsville, Alabama, to support long-term growth and innovation, including the production of Epioxa.
The selected topic was not discussed during the call.
The earnings call presents strong financial performance with significant growth in key franchises, a robust balance sheet, and positive guidance. The Q&A highlights confidence in iDose and Epioxa, despite some uncertainties in payer coverage and FDA decisions. The raised guidance and promising pipeline developments further support a positive sentiment. However, some caution is warranted due to potential market headwinds and unclear responses in the Q&A.
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