Q1 2025 Earnings Summary
- Accelerated iDose Adoption: Executives highlighted that iDose performance exceeded expectations in Q1, with a $21 million revenue contribution and an implied $85 million run rate annualized, underpinned by strong reimbursement momentum from key MACs like Noridian and emerging improvements with Novitas and First Coast .
- Robust Physician and Market Execution: The call underscored strong physician buy‐in and confidence. Training capacity is not a bottleneck, and both doctors and patients are providing positive feedback on iDose outcomes, which supports continued growth and potential expansion into new payer segments .
- Compelling Pipeline and Dual-Product Opportunity: With the early submission of the post-approval supplement for iDose reimplantation and ongoing studies combining iDose with iStent Infinite, Glaukos is well positioned to capture growth both from its rapidly expanding iDose franchise and its legacy stent business, setting the stage for long-term market share gains .
- LCD restrictions impacting the stent business: The non‐iDose, or stent, business is facing a mid‐single-digit decline due to LCDs removing 10% to 15% of MIGS volumes, which could persist and weigh on overall revenue performance.
- Challenges in achieving streamlined reimbursement: Continued delays and variability in achieving consistent adjudication across multiple MACs (beyond early success with Noridian) create uncertainty for iDose ramp-up, potentially slowing revenue growth.
- Macroeconomic and tariff-related headwinds: Although glaucoma procedures are relatively insulated, an uncertain macroeconomic environment and ongoing tariff concerns could reduce procedural volumes and adversely affect the company’s sales outlook.
| Metric | YoY Change | Reason |
|---|---|---|
Net Sales | Increased ~1% (Q1 2025: $106,664K vs Q4 2024: $105,499K) | Net sales were nearly flat with a modest increase, suggesting that while the company maintained its revenue base from the previous period, there was minimal additional sales volume growth. This stability may reflect mature market penetration and continuation of prior product demand. |
Loss from Operations | Improved by 28% (Q1 2025: –$20,678K vs Q4 2024: –$28,666K) | The improvement in operating performance is likely driven by cost control measures and enhanced efficiency, as evidenced by the better conversion of similar revenue levels into lower operating losses. This suggests that the initiatives implemented in Q4 2024 to streamline operations are starting to pay off in Q1 2025. |
Net Loss | Narrowed by 46% (Q1 2025: –$18,146K vs Q4 2024: –$33,580K) | The significant reduction in net loss reflects the combined effects of improved operating performance and better management of non-operating items. The dramatic decline (46%) compared to Q4 2024 indicates that the company’s measures to reduce expenses and improve margin efficiency have translated into a much lower net loss in the current period. |
Gross Profit | Increased ~7% (Q1 2025: $82,348K vs Q4 2024: $76,864K) | Despite only a 1% increase in net sales, the 7% increase in gross profit strongly points to enhanced cost management and improved operational efficiency, resulting in a higher profit margin. This suggests that even with marginal revenue growth, better management of cost of goods sold helped drive profitability. |
R&D Expenses | Declined ~11% (Q1 2025: $32,353K vs Q4 2024: $36,527K) | The reduction in R&D spending by around 11% indicates a strategic realignment and cost discipline in the company’s innovation efforts. This may be due to a completion or reclassification of major projects from the prior period, alongside tighter budgeting which was likely deliberate after a ramp-up phase in Q4 2024. |
Operating Cash Flow | Improved ~45% (Q1 2025: –$18,521K vs Q1 2024: –$33,870K) | A marked improvement in operating cash flow is attributed to lower net losses and reduced non-cash expenses relative to Q1 2024, along with better working capital management. Despite similar net sales levels, the company generated a significantly lower cash outflow from operations, reflecting efficiencies and effective cost control measures implemented since Q1 2024. |
Liquidity | Declined by 32.6% (Q1 2025: $114,252K vs Q4 2024: $169,626K in cash balances) | The drop in cash and cash equivalents by over 32% indicates that despite operating improvements, substantial cash outflows occurred in financing and/or investing activities. This reduction in liquidity may reflect strategic investments or debt repayments that were prioritized over retaining cash, contrasting with the stronger liquidity position observed in Q4 2024. |
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Full-Year Net Sales | FY 2025 | $475 million to $485 million | Reaffirmed at $475 million to $485 million | no change |
International Glaucoma | FY 2025 | Expected to grow at high single digits, down from >20% in 2024 | Revised to high single-digit to low double-digit growth | raised |
U.S. Glaucoma (Non-iDose) | FY 2025 | Expected to be flat to potentially down low single digits | Anticipated mid-single-digit decline | lowered |
Corneal Health | FY 2025 | Expected to deliver low single-digit growth | Expected to be flat to low single-digit growth | lowered |
iDose Franchise | FY 2025 | Implied to be well north of $100 million with growth in H2 | Modestly increased expectations for the remainder of 2025 | raised |
| Metric | Period | Guidance | Actual | Performance |
|---|---|---|---|---|
Net Sales | Q1 2025 | $475M-$485M for FY 2025, with ~21% in Q1(≈$100M-$102M) | $106.664M | Beat |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
iDose TR Adoption & Performance | Q2, Q3 and Q4 2024 calls consistently highlighted strong clinical outcomes, positive surgeon feedback, and a ramp-up in sales with evidence of mid‐teens growth and doubling trends. | Q1 2025 reported record net sales ($106.7M total, $21M iDose TR sales, and 41% YoY growth), robust training initiatives, and expanding market access that further cement its status as a transformative therapy. | Increasing momentum and bullish outlook |
Reimbursement Challenges & Delays | Earlier periods focused on the shift to a permanent J-code, varied progress across MACs, and complex fee schedules leading to persistent hurdles despite improvements in some regions. | Q1 2025 highlighted streamlining in Noridian along with progress at Novitas and First Coast, yet acknowledged that complexities in MAC adjudication and fee schedules remain a challenge. | Consistent challenge with slight improvement |
Legacy Stent Business & Regulatory Impact | Q2–Q4 2024 discussed LCD restrictions, the expiration of Hydrus royalties, and evolving dynamics for iStent Infinite—resulting in headwinds to legacy stent growth despite some stand-alone gains. | Q1 2025 noted mid-single-digit declines in the stent franchise due to ongoing LCD restrictions (reducing MIGS volume by 10–15%) while some offset was seen with improving iStent Infinite use. | Ongoing regulatory pressures with moderate decline |
International Growth Opportunities & Challenges | Q2–Q4 2024 showcased strong international sales growth driven by new product approvals, infrastructure expansion, and broad-based market execution, though foreign exchange headwinds and competitive pressures were noted. | Q1 2025 demonstrated record international glaucoma net sales ($29M) with 15–19% growth, as the company expanded its global reach even as currency fluctuations and competitive pressures persisted. | Sustained growth with persistent FX and competition challenges |
Pipeline Catalysts & Future Product Innovations | Q2 mentioned progress toward an Epioxa NDA; Q3 and Q4 expanded on a robust pipeline including early Axitinib updates and dual-product strategies across glaucoma and retinal programs. | Q1 2025 provided updates with FDA acceptance for Epioxa NDA review, advancements in Axitinib trials, and broad dual-product strategies that span glaucoma and retinal indications, underscoring a robust innovation pipeline. | Strengthening pipeline with clear near-term milestones |
Manufacturing Inefficiencies & Margin Pressures | Q2 noted scale-up challenges for iDose TR while Q3 described modest manufacturing inefficiencies impacting gross margins (narrowed guidance of 82–83%). | Q1 2025 did not include discussion on these issues, suggesting the focus may be shifting as initial scale‐up challenges are addressed [document not in Q1]. | Improving as production scales up |
Macroeconomic, Currency & Tariff Headwinds | Q3 and Q4 highlighted material FX headwinds and noted uncertainties in the global macro environment; Q2 had minimal discussion on these topics. | Q1 2025 acknowledged an uncertain macroeconomic environment and noted minor currency impacts, while emphasizing domestic manufacturing as a buffer against tariff-related concerns. | Continued uncertainty with modest protective measures |
Medicaid Drug Rebate Program Impact on Corneal Health Revenues | Q2, Q3 and Q4 detailed that entry into the MDRP had pressured Photrexa realized revenues, leading to low-single digit growth and the expectation of a peak headwind around Q4-Q1 transition. | Q1 2025 mentioned that the corneal health franchise (including Photrexa) was impacted by MDRP, resulting in adjusted guidance reflecting flat to low single-digit growth ahead of the anticipated Epioxa launch. | Persistent headwind expected until Epioxa launch |
Shift in Sales Focus | Q2–Q4 indicated a strategic shift toward prioritizing iDose TR—with associated trade-offs resulting in headwinds for the legacy stent portfolio, as seen in mid-teens growth in stent sales slowing in favor of iDose TR expansion. | Q1 2025 continued this focus on ramping iDose TR, as evidenced by strong sales growth, while legacy stent revenues experienced modest declines due to regulatory pressures, confirming continued trade-offs. | Ongoing strategic trade-off favoring iDose TR |
Physician and Market Execution | Q2–Q4 consistently emphasized robust training programs, strong surgeon buy-in, and positive clinical outcomes that drove market adoption, with effective training addressing both surgeons and office staff. | Q1 2025 maintained strong execution with continued robust training, positive clinical outcome feedback, and expanding market access that reinforced strong surgeon adoption and consistent execution. | Consistently strong execution reinforcing growth |
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iDose Ramp
Q: How will iDose ramp to nearly double Q1 revenue?
A: Management expects iDose to build on a strong $21 million run rate from Q1 by leveraging continued monthly progress and expanding payer adjudication in key MACs, driving revenues upward by year's end. -
Guidance Drivers
Q: What components drive full-year guidance?
A: They highlighted record Q1 growth of 25%, balanced by LCD headwinds on stents, with a modest raise in iDose expectations underpinning the full-year guidance range. -
Stent Performance
Q: How is the U.S. stent business performing?
A: U.S. non‑iDose stent revenues declined in the mid‑single digits due to LCD restrictions, offset somewhat by solid iDose gains and gradual market recovery. -
Reimbursement Dynamics
Q: How is iDose reimbursement faring?
A: Management noted strong traction with Noridian and emerging progress with Novitas and First Coast, emphasizing that pricing isn’t the primary impediment to improved reimbursement. -
Economic Sensitivity
Q: How exposed is iDose to economic slowdown?
A: They believe ophthalmology procedures remain relatively insulated, though broader economic pressures could affect scheduling and capital access over the next 6–12 months. -
Commercial Coverage
Q: What progress in commercial iDose coverage?
A: The rollout in commercial and Medicare Advantage is methodical, with current policies covering over 50% of target populations and steady expansion underway. -
Training Capacity
Q: Are training demands met for iDose?
A: There is ample surgeon interest and the sales force is fully capable of meeting training needs across core iStent accounts without capacity constraints. -
iDose Reimplantation
Q: What’s the status on iDose reimplantation efforts?
A: They have already filed the post-approval supplement ahead of schedule and expect FDA feedback within 6 months, likely by year-end. -
Q2 Revenue Outlook
Q: What are the expectations for Q2 revenue?
A: Seasonality and launch dynamics suggest Q2 revenues will modestly improve, with projections around $116 million and iDose revenues near $25 million as the ramp continues. -
Pacing Adjustment
Q: Has iDose guidance been adjusted upward slightly?
A: Yes, management modestly raised iDose expectations—implying a slight overall guidance boost—with continued steady monthly progress reflected in their pacing. -
Combo Procedure Efficacy
Q: Are combo procedure benefits proving meaningful?
A: Clinical evidence increasingly supports the benefits of combining modalities, potentially helping to challenge LCD restrictions through robust data. -
Guidance Assumptions
Q: What assumptions support extra iDose guidance?
A: The outlook is based on streamlined claim adjudication, incremental payer approvals, and gradual commercial roll‐out that collectively drive the revised iDose forecasts. -
Combo Use of iDose
Q: Can iDose be used in combination with MIGS?
A: Yes; since iDose isn’t subject to the recent LCD restrictions, physicians retain full flexibility to use it alongside MIGS procedures. -
Payer Mix Breakdown
Q: What is the expected payer mix for iDose?
A: The emphasis remains on a methodical rollout across both traditional Medicare and commercial/Medicare Advantage, without heavily weighting guidance on any single payer type. -
OpEx Growth Expectation
Q: Will operating expenses grow more than 15% YoY?
A: Management expects OpEx to continue increasing by roughly 15% year‑over‑year, maintaining disciplined investment alongside revenue growth. -
Noridian Utilization
Q: What volumes are seen in the Noridian region?
A: Some sites achieve 15–20 units per month with iDose, though adoption varies as some customers are in the early phase. -
Donut Hole Strategy
Q: How will the donut hole issue be addressed?
A: They plan to leverage the balance sheet to offer a $0 copay program for commercial patients, mitigating out-of-pocket hurdles. -
Legacy iStent Growth
Q: How will legacy iStent grow alongside iDose?
A: Both legacy iStent and iDose are expected to grow in tandem as surgeons shift to a more proactive intervention model, ensuring a long-term market opportunity. -
iStent Infinite Barriers
Q: What challenges remain for iStent Infinite?
A: Adoption is gradually increasing as surgeons adjust their practices, with progress evident from positive industry feedback at recent conferences. -
Patient Conversations
Q: How are doctors discussing iDose with patients?
A: Physicians are increasingly confident about iDose due to its excellent performance, making it an easy and effective value proposition during patient consultations.