STAAR Surgical Reports Third Quarter 2026 Results

Deborah Andrews, Executive Vice President and Chief Financial Officer of STAAR Surgical Company

“Our record nine-month performance keeps us firmly on track to deliver strong full-year GAAP net income with free cash flow and a debt-free balance sheet. Temporary gross margin pressures are expected to abate beginning in the fourth quarter, while China seasonality should moderate revenue and earnings, but not free cash flow.”

Warren Foust, President and Chief Executive Officer of STAAR Surgical Company

“During the quarter, we advanced our commercial, operational, and product development priorities. I am grateful for the opportunity to reflect on what we have accomplished and discuss what is to come. Earlier this year, we set three goals: Revenue Growth, Profit Expansion, and Innovation Acceleration. Through the first nine months, we progressed against all three. We delivered record revenue for the first nine months of 2026, achieved strong profitability, and laid the groundwork to expand our product offerings. Our strong free cash flow and cash position give us the flexibility to invest in innovation and growth while maintaining a debt-free balance sheet. This financial strength also enabled us to establish a $50 million share buyback program in September, reflecting the Board’s confidence in STAAR’s long-term prospects and its belief that the current share price does not reflect the Company’s intrinsic value. As we look ahead, our results give us the confidence to raise our ambitions. EVO ICL redefined the refractive landscape and is leading a market shift from laser to lens. Now we are applying even greater rigor to how we manufacture, how we go to market, and how we operate, across three strategic focus areas. Advance the Future of Vision, enabled by Product Innovation: Investing in R&D, clinical proof, and regulatory progress to expand beyond our core offering and bring meaningful new products to patients. Grow Adoption, enabled by Commercial Innovation: Expanding ICL adoption worldwide through partnerships, surgeon and patient education, practice enablement, and focused commercial execution. Deliver with Excellence, enabled by Operational Innovation: Supporting profitable growth through advancements in manufacturing and supply chain management. Our ability to execute rests on our mission-driven team, our commitment to quality, and a disciplined, returns-focused approach to capital allocation. STAAR’s lens-based vision correction leadership is built on the differentiated capabilities of EVO ICL and our proprietary Collamer® technology. As the global leader in phakic IOLs and the manufacturer of the most clinically studied phakic IOL, with more than 30 years of clinical evidence, over 100,000 eyes studied, and 4+ million lenses distributed worldwide, STAAR has set the standard in cornea-preserving vision correction. With this strong foundation, we are focused on targeted research and development investments, clinical evidence generation, and regulatory advancement to launch new products and expand beyond our core offering. We are approaching an important milestone in expanding our product offering. We have begun the clinical trial process for our next-generation presbyopia technologies, with first-in-human clinical trials for two products expected to begin patient enrollment in the next few months, subject to receipt of the remaining required regulatory authorizations.(2) These studies represent a tangible step from pipeline to patient, and as our programs advance, we expect to give shareholders greater visibility into their potential to expand our market opportunity and drive long-term growth. On the regulatory front, we are expanding EVO’s reach and commercial potential. Recent label expansions raised the U.S. eligibility age to 60, adding approximately eight million potentially eligible patients, and lowered the minimum prescription in Brazil to −0.5 diopters, adding an estimated 26 million potential patients. As our label harmonization efforts continue to broaden access, our commercial priority is to convert expanded eligibility into adoption. We are focused on growing global ICL adoption to capitalize on the market opportunity that we outlined in our September report entitled The Future of Refractive Surgery (FoRS Report). The FoRS report confirmed what we have seen in our own results: the refractive market is shifting, and EVO ICL is driving that shift. Our job now is to accelerate the shift. We are making changes to how we operate commercially, sharpening our global model, strengthening local execution, and removing the barriers that slow surgeons and patients from choosing EVO. To lead that effort, in September we announced the appointment of David Bailey as Chief Commercial Officer, who has returned to STAAR having previously served as CEO. David built much of what STAAR's commercial engine is today, and he returns with a clear mandate to move surgeons from confidence to conviction. That means better education, stronger evidence programs, smarter use of data, and more targeted patient awareness, market by market, surgeon by surgeon. We also recently named Andrew Pilon, O.D. as Vice President of Business Development, reporting directly to me. Andrew is focused on expanding strategic partnerships and identifying new opportunities to broaden our global market footprint. Across our markets, including China, EVO unit growth is outpacing the broader refractive market, and we are taking share. Surgeons and patients are increasingly asking about lens-based correction over laser, and we intend to make sure EVO ICL is their first and only solution. We are focused on achieving advancements in manufacturing and supply chain management to support continued profit expansion. In the third quarter, we completed the operational transition to allow for all China-bound ICLs to be manufactured in Switzerland, an initiative designed to improve gross margin by reducing U.S.-China tariff-exposure while strengthening supply chain resilience. Our ability to scale Swiss production was further enhanced by recently receiving DEKRA certification of a second clean room at our Nidau facility. Additional efforts underway include targeted initiatives to improve manufacturing yields and expand capacity while maintaining the rigorous quality standards required to produce Collamer. We are expanding machining capacity at our Monrovia facility and evaluating automation opportunities throughout our operations. We estimate that each percentage point improvement in manufacturing yield could generate approximately $750,000 to $1 million in annual incremental gross profit. This year, we implemented a new enterprise resource planning (ERP) system, and we ramped up production to support the launch of EVO+ in China, where demand was stronger than anticipated. In addition, we are strengthening our supply chain planning and inventory management capabilities. Over the past four quarters, we made steady progress in reducing distributor inventory in China, which ended the third quarter below our six-month target. Inventory decreased while in-market volume grew, which tells us demand is outpacing current supply. We are adjusting manufacturing capacity to close that gap. With the channel in balance, we believe company shipments will more closely reflect the growth in underlying demand. What we see in China, our largest market, reinforces what we see globally. EVO ICL is gaining share, and the shift from laser to lens-based correction is accelerating. Through the first nine months of 2026, unit volume shipments by our distributors in China grew 12.4%, a meaningful step up from the mid-single-digit growth in 2025. Year-over-year growth so far in 2026 has come from share gains, with in-market volume again outpacing the broader Chinese refractive market. Because of the mix shift to EVO+ and a higher percentage of toric lenses, the average selling price by our distributors of our lenses in China has risen substantially. China sales grew 31% year over year excluding $25.9 million of previously deferred sales recognized in the third quarter of 2025. The deferred China sales related to an order placed and shipped in 2024. It was recognized in the third quarter of 2025 with no corresponding cost of sales, increasing sales and gross profit margin in the prior-year period and affecting year-over-year comparability. Growth in China sales was led by performance in public hospitals. We are encouraged that hundreds of mid-tier hospitals have begun to close the gap with our largest and longest-established centers, which continue to set the benchmark for ICL productivity. In fact, most of our incremental volume increases came from rising procedures per hospital in the mid-tier category. These hospitals still perform a fraction of the procedures our leading centers do, so we are early in this effort with considerable opportunities to increase volumes. We also saw lower-diopter procedures grow faster than higher-diopter procedures, an encouraging signal for our strategy to move EVO ICL down the diopter curve, where the addressable patient population is substantially larger. The increasing adoption of EVO+ and toric relative to EVO and spherical and the outperformance of public hospital channels are still in their early phases but are creating tailwinds that we believe will allow us to realize materially higher average selling prices with further opportunity to increase the mix of EVO+ in China. Because we were not yet fully able to meet lens demand during the third quarter, all of our sales increase in China during the quarter was attributable to increased average selling prices. We remain focused on the underlying drivers of our significant opportunity in China: increasing adoption of EVO+, expanding the reach of lens-based vision correction, supporting surgeon training, deepening our relationships with key hospital systems, and improving patient education and awareness. We recently elevated Ying Chen to President of STAAR Surgical China, strengthening our leadership in our largest market and reinforcing our focus on execution. We will continue to grow and develop our organization in China to expand our capabilities and support long-term growth. Outside China, APAC net sales increased 4% year-over-year, with growth in India, Taiwan, and other APAC markets, partially offset by declines in Japan, primarily due to currency headwinds, and South Korea, due to overall market weakness. We remain focused on supporting surgeons and patients through commercial investment tailored to local market needs, product availability, and patient-awareness activities. Earlier this week, Pascal Aeschlimann was appointed Vice President of Asia Pacific. During his earlier tenure with STAAR, Pascal spearheaded our expansion across Asia and the Middle East, and his expertise will be vital as we capture the significant opportunity across APAC. EMEA net sales increased 31% year-over-year, or 51% excluding the Middle East. We saw strong double-digit growth in Spain, Germany, the UK, and distributor operations. EMEA’s strong growth benefited from improved conditions and a much smaller decline in revenue in the Middle East compared with the first half. Our commercial efforts have supported this growth by expanding surgeon engagement and strengthening customer relationships. User meetings in France and Poland have broadened our reach among surgeons and provided opportunities to share our clinical evidence, while agreements with key partners in Spain and Germany have deepened important customer relationships. In the Americas, net sales increased 14% year-over-year, led by $6.5 million in U.S. sales, our third consecutive quarter exceeding $6 million. Data provided by the Refractive Surgery Council suggests that in 2026, laser vision correction procedures have declined 5.8% vs. 2025. Our consumer research reinforces that many patients want freedom from glasses and contacts, and that they value choice, reversibility, confidence, and understanding their treatment options. This opportunity is reflected in our business performance and treatment patterns in the U.S. Alongside continued adoption among patients with high myopia, we have seen three consecutive quarters of significant growth among patients with less severe myopia, broadening EVO adoption across a wider range of refractive errors. Our focus in the U.S. market is on helping practices translate patient interest into treatment, creating additional revenue opportunities, and making use of their existing infrastructure to service the growth in demand. Building on record net sales achieved through the first three quarters of 2026, our momentum positions us well to deliver strong full-year results. I am proud of the progress that our team has made and confident in the direction of our business. The ongoing shift from lasers to lenses, EVO+ adoption in China, and opportunities across our global markets give us confidence in continued profitable growth. At the same time, we are investing in an innovation pipeline designed to expand our opportunities and accelerate growth in the years ahead. Our teams remain focused and unified in the effort to unlock the long-term value of our business by converting our efforts and investments into results. We will measure our progress through both financial performance and demonstrable execution against our strategic priorities. We look forward to sharing our progress with you as we continue to build sustainable long-term value for our shareholders. Thank you for your continued support and your belief in STAAR.”