STAAR Surgical Reports First Quarter 2025 Results

China ICL Procedure Trends Improving

Tariff Mitigation Activities Implemented

Cost Controls and Restructuring Initiated to Reduce SG&A Run Rate

Earnings Call and Webcast Today at 5:15 p.m. Eastern

STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today reported results for the first quarter ended March 28, 2025.

First Quarter 2025 Financial Overview

• Net sales of $42.6 million down 45% Y/Y due to planned reduction of channel inventory in China
• Net Sales Excluding China of $42.2 million up 9% Y/Y reflecting growth in all key markets
• Gross margin at 65.8% vs. 78.9% year ago due to intentional reduction in U.S. production volumes and readiness for manufacturing in Switzerland
• Net loss of $(54.2) million or $(1.10) per share vs. $(3.3) million or $(0.07) per share year ago
• Adjusted EBITDA¹ loss of $(26.4) million or $(0.53) per share vs. earnings of $5.3 million or $0.11 per share year ago

“STAAR’s first quarter sales were in line with expectations, but we can and will do better,” said STAAR Surgical CEO, Stephen C. Farrell. “Our results do not reflect the earnings power of our business or the strength of our brand. We are making progress working through transitory challenges in our China business, and importantly, we believe that EVO ICL procedure volumes in China are improving compared to the first quarter last year, despite the macroeconomic headwinds. As our distributors in China continue to consume channel inventory to meet this demand, we are on track to resume normalized sales in China in the third quarter. Our ability to drive growth this quarter in all key markets outside of China further demonstrates the potential and opportunity for STAAR to grow EVO ICL adoption.”

Mr. Farrell continued, “In addition, we have made excellent progress on our cost controls and restructuring activities to better align our expenses with our sales. As a result, we are confident that we will resume growth in revenue and Adjusted EBITDA for the full second half of the year. STAAR has outstanding technology, a consistent history of market share gains, a large addressable market supported by the expanding incidence of myopia, a strong balance sheet, and a demonstrated ability to drive profitability and cash flow. We are rapidly turning the corner, and our long-term prospects are excellent.”

First Quarter 2025 Highlights

• Distributor Inventory in China – The Company’s distributors in China have continued to consume channel inventory to support EVO ICL procedural demand and are on track to reduce excess distributor inventory to contracted levels by the end of the second quarter. The Company is actively working with its distributors to better forecast forward demand so that purchases by distributors more closely align with in-market procedure volume and to maintain adequate inventory to meet patient demand without creating excess inventory in the channel.

• Tariff Mitigation – In order to mitigate the potential impact of tariffs on exports to China, the Company negotiated and implemented consignment agreements with its two distributors in China and delivered consigned inventory in advance of the implementation of tariffs. The Company believes it now has sufficient levels of product in country to meet most of its demand through the beginning of 2026, and it is taking steps to ramp up manufacturing capabilities at its Switzerland site to further mitigate potential long-term impacts of China tariffs.

• Cost Controls – The Company is meaningfully cutting costs and is undertaking restructuring activities to reduce its SG&A run rate. For fiscal 2024, the Company recorded SG&A expenses of $252.2 million, which were planned to grow in 2025 due to commitments to investments in human capital and facilities. The Company has identified spend reductions related to facilities, marketing, and staff that are expected to reduce the annualized SG&A run rate significantly below fiscal 2024 to approximately $225 million as the Company exits fiscal 2025. The majority of the restructuring activities are focused on U.S. operations. The Company is also assessing other areas of potential savings, but those incremental savings may be redeployed to fund strategic investments to drive future growth.

• Regulatory Approvals – The Company received EVO/EVO+ ICL approval from the Taiwan FDA during the first quarter. In April, the Company received approval in Brazil for the expansion of its EVO/EVO+ ICL labeling to include spherical power down to -0.5 diopters from -6.0 diopters previously. The Company is pursuing labeling changes in other key markets around the globe and believes that this approval further evidences the growing clinical support for EVO ICL at lower diopter levels. Finally, the Company continues to believe it will receive mid-year approval for its EVO+ (V5) lenses in China.

"We are proud of the great team effort to rapidly ship additional inventory into China and proactively seek ways to navigate the evolving tariff environment to support our growth plans,” said STAAR Surgical President and Chief Operating Officer, Warren Foust. “Not only did our internal teams jump into action, but our distributors in China were great partners as we worked through the logistics of the consignment. We believe this consigned inventory plus distributor-owned inventory already in country will be sufficient to meet most surgeon and patient needs for fiscal 2025 and the beginning of fiscal 2026. In parallel, we are readying our Switzerland manufacturing facility for additional production of EVO ICLs for the China market when we obtain the final validations and approvals, which we expect this summer.”

First Quarter 2025 Financial Results

Net sales were $42.6 million for the first quarter of 2025 compared to $77.4 million in the prior year quarter. The decrease was primarily due to a significant decline in China revenue, as purchases by the Company’s China distributors were minimal in the quarter as they consumed existing in-country inventory to satisfy procedural demand. The decline was partially offset by growth in other geographies. Excluding China, net sales were $42.2 million, an increase of 9% as compared to the prior year period.

Gross profit margin for the first quarter of 2025 was 65.8% of total net sales compared to the prior year quarter of 78.9% of total net sales. The decrease in gross profit margin was primarily due to higher manufacturing costs per unit due to reduced production volumes at the Company’s U.S. manufacturing site and period costs associated with the expansion of the Company’s manufacturing capabilities at its Switzerland site, which reduced gross margin by approximately 6 points. In addition, gross margin was negatively impacted by higher excess and obsolete inventory reserves, which reduced gross margin by approximately 4 points.

Total SG&A expenses for the first quarter of 2025 were $62.7 million compared to $63.3 million in the prior year quarter. The decrease in SG&A is the result of cost savings initiatives that were implemented towards that latter half of the quarter, partially offset by a higher run rate at the beginning of the quarter. General and administrative expenses were $24.5 million compared to $23.2 million in the prior year quarter, primarily due to increased compensation related expenses and facilities costs. Selling and marketing expenses were $24.6 million compared to $26.7 million in the prior year quarter due to lower marketing, promotional and advertising activities. Research and development expenses were $13.7 million compared to $13.4 million in the prior year quarter.

In the first quarter of 2025, the Company also incurred $22.7 million for restructuring, impairment and related charges, primarily for asset write-offs, closed facility charges, and severance associated with the realignment of the Company’s leadership structure and its cost control initiatives. Including these charges, operating loss for the first quarter of 2025 was $(57.4) million as compared to $(2.3) million for the first quarter of 2024. Net loss for the first quarter of 2025 was $(54.2) million or $(1.10) per diluted share compared with a net loss of $(3.3) million or $(0.07) per diluted share for the prior year quarter. The year over year decrease in net income was primarily attributable to lower net sales and restructuring charges.

Cash, cash equivalents and investments available for sale at March 28, 2025, totaled $222.8 million, compared to $230.5 million at the end of the fourth quarter of 2024.

Mr. Foust concluded, “We believe there is a significant opportunity for STAAR to continue to drive adoption of our EVO ICLs. The global myopia epidemic is increasing, and patients are looking for safe and effective long-term vision correction solutions. Our proprietary Collamer® material provides a sustainable competitive advantage in refractive vision correction, and patients and surgeons are increasingly turning to EVO ICL as they look to get rid of their glasses and contact lenses. We also believe in the potential of Collamer for use in other therapeutic applications, especially within the eye.”

Outlook

The Company announced that it is withdrawing the financial outlook previously provided on February 11, 2025.

“Global economic uncertainty and evolving tariff policy make it more challenging to forecast. As a result, despite confidence in our recent efforts to mitigate tariff exposure and our optimism regarding both short-term and long-term business trends, we are withdrawing the Company’s previous financial outlook,” concluded Mr. Farrell.

Earnings Conference Call and Webcast

The Company will host an earnings conference call and webcast today, Wednesday, May 7 at 5:15 p.m. Eastern / 2:15 p.m. Pacific to discuss its financial results and operational progress. To access the webcast please use the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=VN5Skdjp

In addition to live questions, participants may submit questions by email to ir@staar.com

¹ Adjusted EBITDA and Adjusted EBITDA per share are non-GAAP financial measures. For further information on non-GAAP financial measures, please refer to the “Use of Non-GAAP Financial Measures” section of this press release. Please also refer to the tables at the end of this press release for a reconciliation of non-GAAP financial measures to the most directly comparable GAAP measure.

Use of Non-GAAP Financial Measures

To supplement the Company’s financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this press release and the accompanying tables include certain non-GAAP financial measures, including Adjusted EBITDA. Management uses these non-GAAP financial measures in its evaluation of Company operating performance and believes investors will find them useful in evaluating the Company’s operating performance, including cash flow generation, and in analyzing period-to-period financial performance of core business operations and underlying business trends. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income and expense, net; provision for income taxes; and depreciation and amortization to net income. In calculating Adjusted EBITDA and Adjusted EBITDA per diluted share, the Company further adjusts for stock-based compensation expense and for restructuring, impairment and related charges. As stock-based compensation is a non-cash expense that can vary significantly based on the timing, size and nature of awards granted, the Company believes that the exclusion of stock-based compensation expense can assist investors in comparisons of Company operating results with other peer companies because (i) the amount of such expense in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expense can vary significantly between periods as a result of the timing of grants of new stock-based awards, including inducement grants in connection with hiring. Additionally, the Company believes that excluding stock-based compensation from Adjusted EBITDA and Adjusted EBITDA per diluted share assists management and investors in making meaningful comparisons between the Company’s operating performance and the operating performance of other companies that may use different forms of employee compensation or different valuation methodologies for their stock-based compensation. Investors should note that stock-based compensation is a key incentive offered to employees whose efforts contributed to the operating results in the periods presented and are expected to contribute to operating results in future periods. Investors should also note that such expenses will recur in the future. The Company believes that restructuring, impairment and related charges are not indicative of the underlying operating expense profile for the Company. These charges, which include costs related to severance, reduction in force and consulting expenses, impairment expenses on leasehold improvements and machinery and equipment, impairment on real property right-of use assets, and impairment of internally developed software, are anticipated to be completed within a finite period of time and can vary significantly in any specific period. The Company believes that excluding restructuring, impairment and related charges from Adjusted EBITDA allows investors to more consistently analyze period-to-period financial performance of its core business operations and better assess the Company’s current and future continuing operations.

The Company also presents certain financial information on a constant currency basis, which is intended to exclude the effects of foreign currency fluctuations. The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on the Company’s results when reported in U.S. dollars. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the “constant currency” rate to sales or expenses in the current period as well.

In the tables provided below, the Company has included a reconciliation of Adjusted EBITDA and Adjusted EBITDA per diluted share to net income (loss) and net income (loss) per diluted share, the most directly comparable GAAP financial measure, as well as supplemental financial information with net sales expressed in constant currency.

About STAAR Surgical

STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR ICL’s are clinically-proven to deliver safe long-term vision correction without removing corneal tissue or the eye’s natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 3 million ICLs in over 75 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit www.EVOICL.com. To learn more about STAAR, visit www.staar.com.

We intend to use our website as a means of disclosing material non-public information about the Company and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections at investors.staar.com. Accordingly, investors should monitor such portion of our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the Email Alerts section at investors.staar.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: financial projections and forecasts; plans, strategies, and objectives of management for 2025 and beyond or prospects for achieving such plans; expectations for sales, revenue, margin, earnings, expenses, and cost controls; estimates regarding procedural demand, inventory levels, and tariff impacts; expectations regarding regulatory approvals, uses of Collamer, manufacturing and production; use of cash and cash flows; and any statements of assumptions underlying any of the foregoing, including those relating to expected or future financial performance or results. These forward-looking statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from what is expressed or implied by the forward-looking statements, including, but not limited to: our ability to continue our growth and profitability trajectory; our reliance on independent distributors in international markets; a slowdown or disruption to the Chinese economy; global economic conditions; disruptions in our supply chain; fluctuations in foreign currency exchange rates; international trade disputes (including involving tariffs) and substantial dependence on demand from Asia; changes in effective tax rate or tax laws; any loss of use of our principal manufacturing facility; competition; potential losses due to product liability claims; our exposure to environmental liability; data corruption, cyber-based attacks or network security breaches and/or noncompliance with data protection and privacy regulations; acquisitions of new technologies; climate changes; the willingness of surgeons and patients to adopt a new or improved product and procedure; extensive clinical trials and resources devoted to research and development; compliance with government regulations; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; laws pertaining to healthcare fraud and abuse; changes in FDA or international regulations related to product approval; product recalls or failures; and other important factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 27, 2024 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission (the “SEC”) and available in the “Investor Information” section of the Company’s website under the heading “SEC Filings,” as any such factors may be updated from time to time in the Company’s other filings with the SEC. Forward-looking statements speak only as of the date they are made and, except as may be required under applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

We intend to use our website as a means of disclosing material non-public information about the Company and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections at investors.staar.com. Accordingly, investors should monitor such portion of our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the Email Alerts section at investors.staar.com.

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"STAAR’s first quarter sales were in line with expectations, but we can and will do better. We are rapidly turning the corner, and our long-term prospects are excellent.”