Thomas Stephan

Thomas Stephan asked about the U.S. spine surgery environment for 2026, including market-related headwinds and tailwinds, and the general outlook on U.S. surgical volumes given changes in CMS reimbursement and site of care.

Answer

Keith Pfeil, President and CEO, believes the overall market is growing low single digits, with Globus growing 'well above the market.' He sees competitive dynamics but maintains the ability to grow, noting the company is well-positioned for market evolution, including migration to ASC settings, with a complete suite of products. He doesn't foresee current initiatives having a long-term impact.

Thomas Stephan of Stifel asked for Keith Pfeil's outlook on the U.S. spine surgery environment in 2026, considering changes in CMS reimbursement and site of care, and how these factors might impact surgical volumes and Globus Medical's business.

Answer

Keith Pfeil, President and CEO, believes the overall U.S. spine market is growing at low single digits, and Globus Medical continues to grow well above market. He acknowledged competitive dynamics but emphasized the company's ability to grow. Pfeil sees Globus Medical as well-positioned to respond to market evolution, including the migration of procedures to ASC settings, with a complete suite of spine implants and enabling technologies. He does not foresee current initiatives having a long-term negative impact on the business.

Thomas Stephan asked about early positive coverage determinations for Epioxa from commercial and Medicaid payers, seeking elaboration on key highlights and inquiring about any payer pushback on Epioxa pricing or the discontinuation of Photrexa. He also asked about the factors contributing to the sequential deceleration in iDose TR revenue in Q4 2025 and confidence in continued sequential growth for iDose TR in Q1 2026 and throughout the year.

Answer

Joe Gilliam, President and COO, Glaukos, explained that early positive coverage for Epioxa from Medicaid societies and a large Blue plan was surprising given the pre-drug launch phase, noting that conversations have been clinical with no formal pushback on pricing. Regarding iDose TR, Mr. Gilliam attributed the Q4 sequential growth (north of 10%) to a mix shift towards Medicare Advantage and some rep incentive pull-forward, expressing confidence in continued sequential growth for iDose TR in Q1 2026 and throughout the year.

Thomas Stephan asked about early positive coverage determinations for Epioxa from commercial and Medicaid payers, inquiring about key highlights and any payer pushback on pricing or the discontinuation of Photrexa. He also questioned the sequential deceleration in iDose TR revenue in Q4 and the confidence in continued sequential growth for Q1 and throughout 2026.

Answer

Joe Gilliam, President and COO, explained that early positive coverage for Epioxa from Medicaid and a large blue plan was surprising given the pre-drug launch phase, with no formal or informal pushback on pricing. Regarding iDose TR, he attributed Q4 deceleration to a mix shift towards Medicare Advantage and rep incentive dynamics, expressing confidence in continued sequential growth for Q1 and throughout 2026.

Thomas Stephan of Stifel Financial questioned why the full-year 2025 revenue guidance was raised by less than the Q2 beat and asked for a breakdown of the guidance components. He also inquired about the broader state of the interventional glaucoma (IG) market 18 months into the iDose TR launch.

Answer

President & COO Joe Gilliam explained the guidance reflects headwinds in international glaucoma and corneal health (due to the Epioxa transition), which offset the strong iDose TR performance. Gilliam also expressed bullishness on the IG market, noting a pronounced shift in momentum towards proactive treatment, comparing its potential to the size of the cataract surgery market.

Thomas Stephan asked for the U.S. stent growth rate in the quarter, how physicians are reacting to the recent LCD restrictions, and whether the Noridian MAC region serves as a reliable indicator for future iDose adoption.

Answer

President and COO Joseph Gilliam explained that the U.S. stent franchise saw a mid-single-digit year-over-year decline due to LCD impacts, which was more than offset by iDose TR's strong uptake. He confirmed that the Noridian region, with its streamlined reimbursement, is a key case study and its iDose contribution is nearly double its share of covered lives, suggesting it is a strong analog for other MACs.

Thomas Stephan inquired about the key trends observed for iDose TR in the fourth quarter and year-to-date, asking about any new emerging factors or deviations from the initial launch plan. He also requested a breakdown of the 2025 revenue guidance by business segment, with specific interest in the core U.S. iStent business growth.

Answer

President and COO Joe Gilliam characterized the iDose TR launch as having a strong quarter of execution, with revenues roughly doubling from Q3. He highlighted positive real-world clinical outcomes, expanding surgeon training, and significant reimbursement progress, with 5 of 7 MACs now processing the J-code efficiently. Regarding guidance, Gilliam noted that headwinds from new LCDs and the expiration of the Hydrus royalty are expected to lead to flat to low-single-digit down growth for the non-iDose U.S. business in 2025, implying a very healthy contribution from iDose.

Thomas Stephan asked about the key learnings from the iDose TR launch nearly a year post-approval and the primary qualitative factors that will influence its revenue outlook for Q4 2024 and into 2025.

Answer

President and COO Joseph Gilliam highlighted that the most important learning has been the positive clinical outcomes and strong surgeon receptivity. He emphasized that gaining reimbursement confidence is the critical gate to broader adoption. Looking ahead, Gilliam noted that key milestones for 2025 include normalizing payment processes across all MACs, establishing consistent professional fees, and methodically expanding into Commercial and Medicare Advantage coverage.

Thomas Stephan of Stifel inquired about the company's international expansion strategy, including timelines for approvals and launches, and when OUS revenue might become more meaningful. He also asked about the key drivers that would result in performance at the high or low end of the second-half revenue guidance.

Answer

CEO Ron Kurtz detailed the OUS strategy, noting recent MDR certification in Europe and launches in South Korea and Singapore, while mentioning longer regulatory cycles for Japan and China. He expects modest revenue contributions over the next year. CFO Shelley Thunen explained that the low end of the guidance would likely be driven by lower LDD sales, while the high end would be supported by stronger Q4 seasonality for LAL sales.

Thomas Stephan from Stifel raised the investor concern about the U.S. market potentially nearing a saturation point for LAL adoption and also asked about the technological feasibility of developing a multifocal or accommodative LAL.

Answer

President and CEO Dr. Ron Kurtz dismissed saturation concerns, pointing to the low overall market penetration (10-12%) and the LAL's role in growing the premium category. Regarding the pipeline, he affirmed that adjustability is a platform technology that could be applied to all IOL types, including multifocal and accommodative lenses, with development guided by clinical and financial opportunity.

Thomas Stephan asked for more detail on the nature of future LAL advancements, and questioned the confidence in maintaining or reaccelerating LAL utilization growth in 2025 based on the guidance.

Answer

CEO Dr. Ron Kurtz stated that future advancements would be 'all of the above,' including improvements to optics, lens functionality, and ancillary products, driven by customer collaboration. CFO Shelley Thunen addressed utilization by emphasizing that the absolute number of LALs implanted is the key metric, and while the LALs-per-LDD figure may vary quarterly, the company expects it to grow over time in line with overall revenue growth.

Thomas Stephan of Stifel noted that the Q4 guidance seems to imply a deceleration in year-over-year LAL utilization growth and asked for the underlying factors. He also inquired about the strategy for long-term market share gains and how RxSight works to overcome barriers in practices where adoption may have stalled.

Answer

CFO Shelley Thunen responded that as the installed base and absolute numbers grow larger, percentage growth rates will naturally moderate. She emphasized that the focus is on growing the absolute number of LALs per practice. CEO Dr. Ron Kurtz added that utilization continues to grow over time and the field team works on a practice-by-practice basis to drive adoption, often by engaging additional surgeons within a single practice. Both executives highlighted continuous innovation, like LAL+ and new low-diopter lenses, as a key tool to re-engage existing customers and expand usage.

Thomas Stephan of Stifel Financial Corp. asked about year-to-date MIGS market share dynamics following the LCD impact and inquired about underlying procedure volume growth in the market, and how that informs the outlook for 2026.

Answer

Chief Commercial Officer Matt Link stated the company believes it is winning over 50% of procedures where OMNI was previously used in combination, indicating share gains, supported by a record number of active accounts. CFO Ali Bauerlein noted that market estimates for MIGS procedure growth are in the high-single-digits. CEO Paul Badawi added that the company is focused on capitalizing on the market's expected return to growth in 2026.

Thomas Stephan inquired about year-to-date MIGS market trends, OMNI's performance against expectations, and market share dynamics now that surgeons are often forced to choose a single device. He also asked about efforts to reverse Medicare's procedure 'stacking' restrictions and the competitive impact from new entrants like New World's via 360.

Answer

Chief Commercial Officer Matthew Link stated that while overall procedure volume has declined due to reimbursement changes, OMNI's performance is in line with expectations, retaining its position due to its comprehensive efficacy. CEO Paul Badawi added that OMNI's multi-modal design is a strong competitive fit in a 'one MIGS' environment. Regarding competition, Badawi noted that Sight Sciences continues to innovate with OMNI Edge and has not seen a truly disruptive new technology emerge.

Thomas Stephan asked about year-to-date trends in the Surgical Glaucoma market following the disruptive Medicare LCD changes and whether surgeon behavior was normalizing. He also questioned the physician feedback on TearCare's transition from a lucrative cash-pay model to a reimbursed procedure.

Answer

CFO Alison Bauerlein confirmed that Q1 Surgical Glaucoma trends were tracking as expected, with more clarity emerging around physician practice patterns post-LCD restrictions. Executive Matthew Link and CEO Paul Badawi explained that the move to reimbursement for TearCare was a strategic partnership with providers to access the vast majority of patients who cannot afford cash-pay procedures, positioning it as a way to unlock a much larger market.

Thomas Stephan asked about the investment plan for TearCare commercialization, specifically how spending would ramp before and after securing payer wins. He also questioned the company's confidence in its previously stated double-digit surgical glaucoma growth target for 2025, given recent market shifts.

Answer

CFO Alison Bauerlein explained that a base infrastructure for TearCare already exists with over 1,000 trained customers, so incremental investment will be disciplined and follow payer wins rather than precede them. Regarding 2025, she stated that while they expect a return to growth, they are not providing specific targets at this time as they are still finalizing plans. CEO Paul Badawi emphasized that the existing trained provider base significantly de-risks the future commercial launch.

Thomas Stephan asked about the expected performance of legacy contact lenses for the rest of the year and other potential drivers for reacceleration beyond PRECISION7. He also questioned Alcon's confidence in its U.S. IOL share given recent competitive momentum.

Answer

Chief Executive Officer David Endicott explained that while legacy brands are a drag, the strategic shift to newer, higher-margin products is beneficial for the portfolio's profitability. Regarding U.S. IOLs, he stated that while share has come down from a peak of 85%, their current position is durable due to the strength of PanOptix and Vivity, a strong operating room presence, and offsetting share gains in international markets.

Thomas Stephan inquired about the size and outlook for the Hydrus MIGS business amid recent LCD changes and asked for Alcon's view on the contact lens market's 'trade-up' dynamic for 2025.

Answer

CEO David Endicott estimated the Hydrus business at 'a little under 100' million and noted that while they hope to reverse the LCD, the product's efficacy is a key strength. OUS expansion depends on securing reimbursement. For contact lenses, he expects the trade-up from reusables to dailies to remain 'really steady,' as it's a consistent, long-term trend driven by patient preference for comfort and convenience.

Thomas Stephan asked about Alcon's tunable accommodative IOL offering, specifically whether the post-operative adjustments could potentially be performed using existing lasers already in surgeons' clinics.

Answer

CEO David Endicott confirmed that Alcon has several projects in the tunable and adjustable IOL space. He mentioned that one concept involves a laser-based adjustment, which he believes is likely a better long-term technological approach than methods that use UV light to adjust the lens material. He indicated they are actively working on multiple next-generation ideas for both accommodation and tuning.

Thomas Stephan of Stifel inquired about the sell-out trends for ICLs in China during Q1 2025, including any monthly variations and early Q2 trends. He also asked about the competitive impact of Eybrite on ICL adoption and any potential revenue implications for 2025.

Answer

President and COO Warren Foust responded that end-market sales in China were consistent and pleasing throughout Q1, helping distributors reduce inventory. He characterized the competitive impact from Eybrite as 'immaterial thus far.' CEO Stephen Farrell added that competition can be beneficial in the long run by increasing overall market awareness for lens-based procedures.

Thomas Stephan of Stifel Financial Corp. inquired about the sell-out trends for ICLs in China during Q1 2025, seeking monthly details and insights into Q2 and the upcoming summer season. He also asked about the competitive impact of Eybrite.

Answer

President and COO Warren Foust responded that Q1 end-market sales in China were consistently paced across all three months, which was a pleasing start to the year. Regarding competition, Foust stated that the impact from Eybrite has been immaterial so far, with limited uptake despite promotional efforts. CEO Steve Farrell added that increased competition could be beneficial in the long run by raising overall awareness of surgical vision correction options.

Thomas Stephan of Stifel sought a high-level explanation for the China inventory issues and the resulting accounting impact, asking for assurance that these problems would be remediated and not pose a future risk. He also asked for clarification on Q4 China sales figures and the potential impact of competitor iBright on guidance and distributor behavior.

Answer

CFO Patrick Williams explained the inventory issue was a timing problem related to a single order from one distributor, and the company is now shifting its focus to incentivizing sell-through rather than sell-in to prevent recurrence. CEO Tom Frinzi asserted that the distributor's actions were not influenced by the iBright launch, emphasizing STAAR's market leadership, broader product portfolio (including toric lenses), and extensive clinical history. Patrick Williams also confirmed the $7.5 million in Q4 China sales occurred in October and November.

Thomas Stephan of Stifel inquired about the 2025 growth outlook, asking for context relative to the Q4 exit rate, and sought details on the intra-quarter trends in China that led to the revised guidance.

Answer

Tom Frinzi, Chair, President and CEO, stated it was premature to provide a 2025 outlook but reiterated the company's history of outpacing the market. Regarding China, he noted that the high season tapered off in August and September but emphasized that STAAR continued to gain market share and that the headwinds are viewed as transitory, with positive signs from recent government stimulus.

Thomas Stephan of Stifel inquired about the potential for growth to accelerate in 2025 to meet the 'Vision 2026' target of a 15% CAGR. He also questioned the timing and motivation for potential M&A, given the stock's valuation and the early stage of the U.S. market.

Answer

Executive Patrick Williams addressed the growth outlook, reiterating the 'Vision 2026' goal and pointing to the reacceleration expected in the second half of 2024, noting new initiatives need time to take effect. Regarding M&A, Executive Thomas G. Frinzi stated the company is focused on execution and growing its business, dismissing rumors.