Q1 2024 Earnings Summary
- Glaukos is experiencing strong growth and positive adoption of its new products, particularly iStent infinite and iDose TR, with iStent infinite contributing to mid-teens growth in the U.S. glaucoma franchise in Q1 2024, and expectations that iDose TR will drive significant growth in the second half of 2024 and beyond.
- The company raised its full-year 2024 revenue guidance, reflecting confidence in business momentum and strong execution, particularly with iDose TR set to become a material driver of results in the second half of 2024.
- Gross margins are expected to be accretive over time with the ramp-up of iDose TR, leading to improved profitability starting next year, as the company manages expenses effectively and anticipates margin improvements from new product launches.
- Growth is expected to slow down in Q2-Q4 due to tougher year-over-year comparisons and currency headwinds, with Joseph Gilliam noting "we see an incremental 200 basis points of growing headwind on that international growth number" and that "the comp... starts to get a little bit more difficult."
- The launch of iDose TR may cause operational inefficiencies, leading to potential volatility in gross margins. According to Alex Thurman, "there should be or could be some volatility as we go through the next couple of quarters and iDose gets ramped up."
- Adoption of iDose TR may be slower than anticipated due to reimbursement challenges, as some physicians may "wait for payment to adopt" until the J-code becomes effective on July 1, 2024, potentially limiting near-term revenue growth.
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iDose Ramp and Revenue Outlook
Q: How will iDose adoption drive revenue growth?
A: The company expects iDose to become a significant revenue driver in the second half, especially in Q4 when the J-code and ASP are established. Early access has expanded beyond the initial 15 surgeons, and excitement is high. However, the initial contribution in Q1 was small, as most adoption is expected after reimbursement mechanisms are in place. -
Guidance and Conservative Raise
Q: Why not raise guidance more given the Q1 beat?
A: Despite a strong start, the company maintained a conservative approach, noting that much of iDose's contribution will occur in the second half. Factors such as foreign exchange headwinds and tougher comps ahead also influenced guidance. -
Profitability and Gross Margins with iDose
Q: Will iDose affect margins and profitability?
A: Gross margins may fluctuate between 82% and 84% due to iDose launch inefficiencies. Over time, iDose is expected to be accretive to margins, boosting profitability into next year. -
Patient Co-pay and Reimbursement
Q: How will you address patient co-pays in Medicare and commercial plans?
A: For Medicare, most patients have supplemental coverage reducing out-of-pocket costs. In the commercial segment, the company plans to offer full co-pay assistance to minimize patient financial burden. -
iDose Label and FDA Discussions
Q: Any updates on getting a replacement label from the FDA?
A: The company plans to propose moving towards readministration and hopes for a positive FDA response soon, though timing is uncertain. They expect the TREX clinical trial to regain by year-end, aiming for commercial availability around 2027-2028. -
Impact of iDose on Base Business
Q: Is iDose affecting your core business and market share?
A: The iDose launch is enhancing the base business, contributing to mid-teens growth in the stent portfolio. The company believes it is both growing the market and taking share due to increased enthusiasm and portfolio expansion. -
Surgeon Training Capacity
Q: How will surgeon training progress going forward?
A: Training will expand methodically, with aggressive targets set for the commercial team. While past training peaked at 700-800 surgeons per year, the focus now is on surgeons already experienced with angle-based surgery, potentially increasing training efficiency. -
iStent Infinite Performance
Q: How is iStent Infinite performing?
A: iStent Infinite is a key growth driver, contributing to mid-teens growth in the stent portfolio. The company expects sequential growth to continue and remains confident it can become a several hundred million dollar product over time. -
Rollout Constraints for iDose
Q: Are there any constraints in iDose adoption?
A: No significant supply constraints are expected. Adoption ahead of the J-code may vary based on surgeons' experience with miscellaneous codes and reimbursement confidence. -
Specialty Pharmacy Channel
Q: What's the plan for the specialty pharmacy channel?
A: The specialty pharmacy setup is ready, leveraging experience from Photrexa. The channel will be utilized more as commercial payer coverage for iDose expands. -
Gross Margin Expectations
Q: Will gross margins change next quarter?
A: Gross margins may show volatility due to iDose ramp-up but are expected to remain in the 82%-84% range this year. -
U.S. Glaucoma Business and MACs
Q: What's the impact of MAC movements on the glaucoma business?
A: The impact has been minimal, with a modest benefit to the stent side. The company expects to hear more from MACs but continues to support physicians' clinical decision rights. -
Operating Expense Growth
Q: Is OpEx growth still expected at 10%?
A: Yes, the company anticipates about a 10% year-over-year increase in operating expenses. -
iDose Surgeon Adoption Patterns
Q: How quickly are surgeons adopting iDose?
A: Adoption varies; some surgeons proceed after initial cases, while others wait for reimbursement confirmation. -
Reimbursement with MACs
Q: Any updates on professional fee coverage from MACs?
A: Educational efforts are ongoing; coverage typically takes 6 to 9 months to become consistent and usually occurs gradually, not all at once. -
iStent Infinite Market Potential
Q: Are you confident iStent Infinite can be a $50-100M business?
A: The company remains confident, seeing strong results and early penetration indicating significant future potential. -
Training Rate for Reps
Q: Can reps train more surgeons given prior experience?
A: While many surgeons are already experienced, reps also balance multiple products, so training rates will be assessed as the rollout progresses. -
Early iDose Utilization
Q: How is iDose being used initially?
A: Early use focuses on stand-alone procedures, with some use in combination based on clinical needs. Patient selection varies, and utilization patterns differ among surgeons.
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