Q2 2024 Earnings Summary
- U.S. glaucoma sales expected to grow nearly 30% in 2024, driven by strong performance of the iStent portfolio and better-than-expected contributions from iDose TR. This is evidenced by a 26% year-over-year growth in the second quarter, indicating robust demand and successful product launches.
- International glaucoma business projected to deliver low to mid-teens growth for 2024, demonstrating successful expansion and execution in international markets. The company is enthusiastic about new product introductions and approvals, contributing to this strong trajectory.
- Margin accretion expected to expand over the course of next year as iDose TR fully launches, potentially leading to improved profitability. Despite initial manufacturing inefficiencies during scale-up, the company anticipates gross margins to improve beyond the current range of 82% to 84%.
- Delays in iDose TR reimbursement and adoption may hinder near-term revenue growth. The company expects iDose TR adoption to increase mainly in the fourth quarter and into 2025 due to reimbursement hurdles and the need for physicians to gain reimbursement confidence. This transition period in the third quarter could impact revenue growth.
- Shifting focus to iDose TR may dampen growth in existing stent portfolio. As the sales force focuses more on iDose TR, the company anticipates some dampening of growth in their stent portfolio, potentially affecting overall revenue.
- Ongoing headwinds from the Medicaid Drug Rebate Program (MDRP) may impact Corneal Health revenues into 2025, affecting profitability. The company expects that MDRP-related headwinds may persist into 2025, and initial inefficiencies in iDose TR manufacturing are currently a headwind to margins.
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iDose TR Launch and Revenue Impact
Q: What's driving iDose TR's launch progress and revenue outlook?
A: Management noted that iDose TR's launch has gone as planned, contributing better-than-expected revenues in Q2 alongside a 26% year-over-year growth in U.S. glaucoma sales. They expect momentum to build as reimbursement hurdles are cleared, particularly with the J-code in place by Q3, leading to increased adoption in Q4 and into 2025. -
Profitability Outlook and Cash Flow Breakeven
Q: When do you expect to reach cash flow breakeven?
A: The company aims to achieve cash flow breakeven and begin generating cash in 2025, as iDose ramps up. While profitability is not the near-term focus due to ongoing investments in a rich pipeline, they anticipate starting to see improvements in cash flow over time. -
iDose Readministration Potential and FDA Decision
Q: Do you need additional trials for iDose readministration approval?
A: Management stated they do not need additional clinical trials for iDose readministration. They have submitted a reconsideration request to the FDA and are hopeful but cautious about approval. If unsuccessful, they are progressing with iDose TREX trials by year-end, which could serve as an alternative. -
Guidance Update and Growth Drivers
Q: How does the updated guidance reflect iDose and other segments?
A: The company raised full-year guidance by $12 million, exceeding the Q2 outperformance of $7 million. This increase is due to strong U.S. glaucoma growth and international glaucoma expectations of low to mid-teens growth. However, they anticipate potential growth headwinds in the stent portfolio as the sales team focuses on iDose TR. -
Stent Portfolio Performance and Potential Headwinds
Q: Should we expect mid-teens growth in stents to continue?
A: While the stent portfolio experienced mid-teens growth in the first half, management is not counting on that pace in the second half due to the sales team's focus shifting to iDose TR. They are preparing for potential growth dampening in the stent business. -
Gross Margin Impact from iDose
Q: How is iDose affecting gross margins?
A: iDose did not significantly drive margin improvement in Q2; in fact, the iDose facility is currently a headwind to margins due to manufacturing inefficiencies during scale-up. They expect margin accretion to expand over the next year as iDose fully launches. -
Sales Force Strategy and Leverage
Q: Are there plans to increase the sales force with iDose launch?
A: The company has no plans for wholesale changes to the sales force size but expects organic additions over time. They anticipate leveraging the existing team, with ophthalmology allowing for significant scalability without extensive hiring. -
International Glaucoma Business Growth
Q: What's driving international glaucoma growth?
A: International glaucoma is expected to deliver low to mid-teens growth for the year, reflecting strong first-half performance. Drivers include new product introductions, market expansion, and focus on interventional glaucoma opportunities. -
Corneal Health Business Outlook
Q: How will the corneal business perform after MDRP headwinds?
A: The corneal business is expected to deliver low single-digit growth for 2024. While MDRP headwinds may persist into 2025, the underlying business is expected to return to or exceed past growth levels as these headwinds subside. -
Seasonality and Revenue Expectations
Q: How should we model revenue progression in coming quarters?
A: Due to seasonality, Q3 is typically softer than Q2, with historical sequential step-downs of several million dollars. iDose growth is likely weighted towards Q4, making it prudent to be conservative for Q3 expectations. -
Adoption Dynamics and Competitive Switches
Q: Are you seeing competitive switches to iDose?
A: It's early to make definitive statements, but management expects iDose to be an early intervention option, potentially leading to shifts in treatment algorithms. They hope to benefit from a halo effect across their product portfolio as iDose adoption grows. -
iStent infinite Performance
Q: Is iStent infinite still larger than iDose?
A: Yes, as of now, the stent portfolio and iStent infinite remain the dominant components of the U.S. glaucoma revenue base. However, this is expected to shift as iDose continues to ramp up. -
Epioxa Launch Timing
Q: When is the Epioxa product expected to launch?
A: The company is preparing for a significant launch of the Epioxa product as they exit 2025 and enter into 2026. -
iDose Availability Outside the U.S.
Q: What's the timeline for iDose launch internationally?
A: The company is cautious about international iDose TR launches due to complex pricing environments and is currently evaluating various markets. -
OpEx Growth Expectations
Q: How is OpEx expected to trend for the remainder of the year?
A: OpEx is expected to grow approximately 10% year-over-year, reaching around $400 million for 2024, consistent with prior guidance.
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