2024 Guidance and iDose Impact
Q: How much of iDose is factored into 2024 guidance?
A: Management is pleased with the business momentum and notes that the 2024 guidance implies another year of accelerating growth. While acknowledging the importance of iDose, they state it's too early to provide specific numbers but expect iDose to become an increasingly material driver throughout the year and especially into 2025. "

FDA Re-administration Approval for iDose
Q: Any updates on FDA decision for iDose re-administration?
A: The company is re-petitioning the FDA for re-administration of iDose. They are awaiting changes within the FDA's CDER division before submitting their petition and are hopeful for a successful outcome. If not, they have iDose TREX—containing twice the medication—planned for clinical trials by year-end, targeting commercial approval in 2028. "

iDose Launch Strategy and Rollout
Q: What is the plan for the controlled iDose launch?
A: Currently in an early-access phase with initial procedures completed, the launch will transition from crawling to walking to jogging to running. They will start training doctors gradually, opening up more broadly in the second half, with momentum building into the fourth quarter—aligned with market access milestones like a fully established J-code and published ASP. "

iDose Pricing and Reimbursement Confidence
Q: Are payers and physicians accepting iDose pricing?
A: After extensive research and discussions with payer groups, management is confident they've priced iDose appropriately. Positioned in the median of procedural pharmaceuticals, with examples like RETISERT at $18,000–$19,000 and DURYSTA at around $2,000 for a few months' therapy, they believe surgeons understand the value, and they foresee no impediments to utilization. "

Operating Expenses in 2024
Q: How will operating expenses look in 2024 with investments?
A: Both SG&A and R&D will grow in 2024 due to investments in the iDose launch and pipeline. Starting from a baseline of $360 million in adjusted operating expenses for 2023, they expect about a 10% growth, implying 2024 OpEx just shy of $400 million. "

Gross Margin Expectations with iDose
Q: How will iDose launch affect gross margins?
A: iDose is expected to be accretive to gross margin over time, though there may be modest volatility during the ramp-up and scaling. For 2024, they expect the overall gross margin to land in the upper end of their 83% to 84% range, probably around 84% for the year. "

iDose Impact on Existing Products
Q: Will iDose cannibalize traditional MIGS procedures?
A: In the short term, iDose isn't expected to significantly impact practice dynamics. Over the long term, management anticipates iDose may cannibalize some traditional MIGS procedures as surgeons gain confidence. They expect iDose to become the cornerstone of the interventional glaucoma paradigm, with practices spending more time on minimally invasive solutions. "

Seasonality Shifts Due to iDose
Q: Will seasonality be affected by the iDose launch?
A: Traditional revenue patterns will be disrupted in 2024 due to iDose and the growing infinite business. There's an expected shift of seasonality to the second half, particularly the fourth quarter, driven largely by the iDose launch. "

Medicaid Rebates Headwind
Q: Any headwinds for corneal products in 2024?
A: They anticipate new headwinds in 2024 as the $0 floor for Medicaid rebates expired on December 31, leading to incremental government rebating year-over-year. This will affect the corneal health business, despite strong momentum seen in Q4. "

Epioxa Pipeline Outlook
Q: What's the vision and timing for Epioxa?
A: Results from the second Phase III trial are expected by midyear, with an NDA submission by end of year. They aim for approval in late 2025. Epioxa offers significant benefits by not requiring removal of the corneal epithelium, potentially increasing patient adoption and improving visual rehabilitation. "