What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-03 compared with 2025-02-21 · 149 added, 119 removed, 213 unchanged (56% of the section changed)

26 unchanged sentences

As the Company has focused its business and strategy on its ICL product offerings, we have phased out our cataract IOL product line.

For the fiscal year ended December 27, 2024, approximately 100% our net sales were generated from sales of ICLs.

For the fiscal year ended January 2, 2026, approximately 100% our net sales were generated from sales of ICLs.

Termination of Alcon Merger Agreement

As previously disclosed, on August 4, 2025, STAAR entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Alcon Research, LLC, a Delaware limited liability company (“Alcon”), and Rascasse Merger Sub, Inc., a Delaware corporation and a wholly owned direct subsidiary of Alcon (“Merger Sub”).

The Merger Agreement provided, among other things, that subject to the satisfaction or waiver of the conditions set forth therein, Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly owned subsidiary of Alcon.

The Company and Alcon entered into two amendments to the Merger Agreement, on November 7, 2025 and December 9, 2025, and the Company held a special meeting of stockholders (the “Special Meeting”) to vote on the Merger on January 6, 2026.

At the Special Meeting, the Company’s stockholders voted against the Merger, and the Merger Agreement was terminated in accordance with its terms effective January 6, 2026.

None of the Company, Alcon or Merger Sub was required to pay any termination fee as a result of the termination of the Merger Agreement, and the parties are responsible for their respective costs and expenses related to the Merger Agreement and the transactions contemplated thereby.

During fiscal 2025, we incurred $17.1 million in professional fees and expenses related to the Merger, which are recorded as Merger transaction and related costs on the Consolidated

Statement of Operations.

Following the termination of the Merger Agreement, on January 14, 2026, STAAR entered into a letter agreement (the “Cooperation Agreement”) with Broadwood Partners, L.P.

and its affiliates (“Broadwood”), the Company’s largest stockholder.

The Cooperation Agreement provided for certain governance and leadership changes, as well as reimbursement by the Company of approximately $7.0 million in expenses incurred by Broadwood and other stockholders in connection with their engagement with the Company, including the Special Meeting.

See Note 1 – Organization and Description of Business and Accounting Policies – Termination of Alcon Merger Agreement and Note 19 – Subsequent Events to the Consolidated Financial Statements for information about the Merger Agreement and the Cooperation Agreement.

Business Environment and Factors Affecting Comparability

Given the size of the Company’s business in China relative to its net sales in the rest of the world, macroeconomic conditions in China have a significant impact on the Company’s business, operations, and financial results.

For the fiscal year ended December 27, 2024, we reported $313.9 million of net sales, a decrease of 3% compared to $322.4 million in fiscal 2023, and we incurred a net loss of $20.2 million compared to net income of $21.3 million in fiscal 2023.

We reported net sales of $239.4 million, $313.9 million, and $322.4 million for fiscal years 2025, 2024, and 2023, respectively.

The significant decreases in net sales were primarily due to the dynamics within our business in China where the continued sluggish economy and weak consumer consumption contributed to fluctuating demand for ICL procedures.

We incurred net losses of $80.4 million and $20.2 million for fiscal years 2025 and 2024, respectively.

Prior to fiscal 2024, we had reported over ten years of annual net sales growth, and we had delivered net income profitability since 2018.

Our results in fiscal 2024 were negatively impacted by a significant decline in ICL sales in China in the fourth quarter ended December 27, 2024, where the sluggish economy and weak consumer consumption contributed to fluctuating demand for ICL procedures.

During the fourth quarter ended December 27, 2024, we shipped a $27.5 million order of ICLs to one of our distributors in China.

After the shipment was received, the distributor raised concerns about the ongoing fluctuations in procedural volumes in China and forecasted demand for fiscal 2025.

Following discussions with the distributor, the distributor requested extended payment terms for the order, and we agreed.

From time to time, we agree to extended

payment terms with our distributors, but given that these payment terms were significantly longer than the terms included in our distributor agreement, we determined that under accounting principles generally accepted in the U.S.

(“GAAP”), collectability was not probable, and we did not recognize the revenue associated with the shipment in the quarter ended December 27, 2024.

As the shipment was received by the distributor, and control of the product passed to the distributor, the product is no longer recorded in our inventory.

Ordinarily, we recognize revenue upon shipment of product, and we record cost of sales when we recognize revenue based on the matching principle under GAAP.

In this instance, we did not recognize the revenue, but we did recognize costs of sales associated with this order of $3.9 million, which had a negative impact on our gross profit and gross profit margin for the fourth quarter and fiscal year ended December 27, 2024.

As the control of the inventory transferred to the distributor, accounting rules require us to record the costs of sales upon such transfer, even if revenue is not recognized until a future period.

Under the extended payment terms, the distributor agreed to pay for the $27.5 million order by the end of the quarter ending September 26, 2025.

Revenue for the order will not be recognized until payments are received from the distributor, at which point the collectability concern is alleviated.

Because the cost of sales associated with this order was recognized in the quarter ended December 27, 2024, there will be no associated cost of sales for this order when the revenue is recognized, resulting in a 100% gross profit in the period payments are received.

While we did not recognize revenue on this order upon shipment, we believe that having these ICLs in-country in China can help address challenges and delays associated with importation and logistics and can mitigate potential impacts from geopolitical risk and tariff changes.

Our agreements with our distributors in China provide for minimum inventory requirements based on forecasted demand.

During fiscal 2024, our distributors purchased lenses above such minimums in anticipation of higher procedural volumes during what is typically a summer “high season” in China.

Aggregate net sales to our two distributors in China were $77.8 million for fiscal year 2025, compared to $162.3 million for fiscal year 2024.

China net sales for fiscal year 2025 included $27.5 million related to the previously disclosed December 2024 ICL shipment that was subject to extended payment terms, and which was paid in full in fiscal 2025 pursuant to such payment terms (the “December China Shipment”).

As previously disclosed, we shipped $27.5 million of ICLs in December 2024 to one of our distributors in China for which the distributor requested extended payment terms through September 2025.

Given the extended payment terms, net sales for the shipment were not recognized by us until payments were received.

As the cost of sales associated with the December China Shipment was recognized in December 2024, the payments, when made, were recognized at 100% gross margin in the applicable quarter.

During fiscal 2025, our distributors in China purchased fewer ICLs, as they were able to satisfy procedural demand largely from their existing inventory.

Our distributors in China have historically purchased products from us in bulk shipments in advance of anticipated demand, which they use to satisfy orders from hospital customers based on scheduled surgeries.

During fiscal 2024, our distributors in China purchased lenses above contracted minimums in anticipation of higher procedural volumes during what is typically a summer “high season” in China.

Due to dynamic macroeconomic conditions and other factors, the number of ICL procedures performed during the high season and the second half of 2024 overall was lower than expected.

Accordingly, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory.

We believe that volatility in surgical procedure volumes will continue until consumer confidence stabilizes and ultimately improves in China.

As a result, we believe that the level of ICL inventory held by our distributors in China is sufficient to meet currently expected procedure volumes for at least the first half of fiscal 2025.

We therefore anticipate we will report minimal China ICL sales in the first half of fiscal 2025.

As China in-country inventory is reduced during the first half of fiscal 2025, we would expect our China revenue to normalize.

However, our ability to successfully address these challenges will depend on a number of factors, including the risk of a prolonged slowdown or disruption in China and the institution of trade tariffs both globally and between the U.S.

and China, as set forth in Item 1A.

“Risk Factors.”

The level of inventory owned by our distributors in China has decreased substantially since December 27, 2024, and has returned to contractual levels.

As anticipated, we reported lower China ICL sales in fiscal 2025 compared to fiscal 2024.

In April 2025, in response to the announcement of tariffs by the United States on Chinese goods, China announced retaliatory tariffs on U.S.-origin goods.

In order to mitigate potential financial exposure from such tariffs, we negotiated and implemented consignment agreements with our two distributors in China, and we delivered consigned inventory to China in advance of the implementation of tariffs and delivered additional consignment inventory throughout fiscal 2025.

While the tariff situation is evolving, we believe that these efforts to increase the amount of ICLs in China reduce the Company’s tariff risk in China in the near-term.

In addition, we are rapidly ramping up our production capabilities in Switzerland to supplement our manufacturing capacity in the United States to provide optionality under multiple tariff scenarios.

Given that we maintained consigned inventory in China in 2025, purchases by our distributors were satisfied in part from our consigned inventory, rather than through bulk purchases.

As our China distributor inventory levels have normalized, we intend to reduce our consigned inventory levels in China going forward.

We reduced our China inventory levels in 2025, and we have taken steps to mitigate the risk of elevated inventory buildup by our distributors, while at the same time maintaining sufficient ICL inventory in China to support quick and efficient delivery and fulfillment for surgical procedures.

In 2025, we expanded our manufacturing capabilities for our ICL products in our Nidau, Switzerland facility.

As we ramp up ICL manufacturing in Nidau, Switzerland, our costs are expected to increase given the expense of operating two sites and lower site utilization impacts cost absorption.

The on-going operation of two manufacturing

sites will create pressure on gross margins.

Over the longer term, as we grow revenue and align sales with manufacturing production, we would expect our gross margin to improve.

We also expect the operation of two manufacturing sites will lead to higher inventory levels in the near-term.

During fiscal 2026, we will continue to assess appropriate inventory levels, both inventory held by us and inventory held by our distributors.

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In addition, our distributors hold their own inventory in-country based on forecasted demand.

During fiscal 2024, we increased our inventory levels to meet the significant level of anticipated demand for our ICL lenses, to support quick and efficient delivery and fulfillment for surgical procedures, and to mitigate risks associated with potential disruptions to our manufacturing and production process.

During fiscal 2026, we expect to adjust our production output based on forecasted demand and optimize the level of inventory held by us and held by our distributors.

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We want to be the first choice for doctors and for patients seeking visual freedom from wearing eyeglasses or contact lenses.

A key focus in 2025 will be supporting our business in China as we work to navigate the macroeconomic challenges and position the Company for growth once the market recovers.

Across our markets, we

recognize the need to further educate and train ophthalmic surgeons about our ICLs and our ICL procedure.

In 2025, we intend to increase the number of strategic collaborations with leading refractive surgeons and practices in the U.S.

to collaborate on marketing, training and education activities.

We also plan to leverage our new EVO Experience Center at our headquarters in Lake Forest, CA, to conduct additional hands-on training and education in lens-based vision correction.

The Company is navigating market headwinds, geopolitical factors and a dynamic environment in key regions, including China.

In 2026, we are aligned around three focused priorities to allow us to advance around this goal.

Focused growth – we are focused on revenue growth in our key markets, with a strong emphasis on execution.

This includes sharpening commercial focus, prioritizing where we can win, and improving consistency across markets.

Across markets, we intend to maximize the impact of our strategic customer agreements and develop relationships with customers that position EVO ICLs to treat refractive error more broadly.

Focused investment – we believe growth must be sustainable.

In 2026, we will continue to prioritize investments that support long-term value creation, with a clear focus on what drives results and expands profits by investing wisely in key markets.

Across our markets, we recognize the need to further educate and train ophthalmic surgeons about our ICLs and our ICL procedure.

We also plan to leverage the EVO Experience Center at our headquarters in Lake Forest, California, to conduct additional hands-on training and education in lens-based vision correction.

In addition, we are continuing to invest in enhanced systems and tools to make ordering and fulfillment faster and easier.

In 2026, we will also continue to drive awareness of the ICL procedure to reach even more potential patients and effectively communicate the clinical benefits of our ICLs.

While we work to launch our existing product portfolio in attractive global markets, we also intend to continue to invest in product innovation in 2025.

Focused innovation – innovation remains central to the Company’s future.

We are focused on accelerating our innovation pipeline with rigor, prioritizing programs that deliver meaningful clinical and commercial impact.

We are driving innovation through focused development, execution with key milestones, and innovative thinking around market needs.

Our innovation pipeline footprint will be expanded in 2026 with the full launch of EVO+ in China to allow more patients to have access to this premium, larger optic lens.

We also intend to expand our product offering with the launch of additional lens sizes to allow for greater surgeon flexibility.

Results of Operations

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Percentage of Net Sales

Net sales (1)

Cost of sales (1)

Gross profit (1)

General and administrative

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Research and development

Merger transaction and related costs

Restructuring, impairment and related charges

Total selling, general and administrative

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Income (loss) before income taxes

Provision for income taxes

Provision (benefit) for income taxes

Net income (loss)

The following table presents our net sales, by product for the fiscal years presented (dollars in thousands):

Other product sales

Cataract IOLs

Other surgical products

Total other product sales

(1) For fiscal 2025, amounts include $27.5 million of net sales related to December China Shipment.

As the associated cost of sales was recognized upon shipment in December 2024, these amounts were recognized at 100% gross margin for fiscal 2025.

The following table presents our net sales (dollars in thousands):

Percentage Change

Net sales for 2025 decreased 23.7% from 2024.

The decrease in net sales was due to decreased ICL sales of $6.9 million and decreased other product sales of $1.6 million.

Net sales for 2023 increased 13% from 2022.

The increase in net sales was due to increased ICL sales of $49.7 million, partially offset by a decrease in other product sales of $11.7 million.

Total ICL sales for 2024 decreased 2% from 2023, with units down 6%.

The sales decrease was driven by the APAC region, which decreased 6% with units down 9%.

The decrease in the APAC region was driven by decreased sales in China, primarily related to the $27.5 million order in December 2024 for which we did not recognize revenue discussed above, partially offset by sales growth in India, other APAC Distributors, Japan and Korea.

The Europe, Middle East and Africa region sales increased 10% with unit growth up 17%, due primarily to sales increases in our distributor markets.

The Americas region sales increased 16%, with unit increase of 17%, due primarily to sales growth in the U.S.

Changes in foreign currency unfavorably impacted ICL sales by $2.7 million, which impacted our Japan and Europe, Middle East and Africa markets.

ICL sales represented 99.6% of our total sales for fiscal year 2024.

Total ICL sales for 2023 increased 18% from 2022, with unit growth up 19%.

The sales increase was driven by the APAC region, which grew 21% with unit growth of 22%, primarily due to sales growth in China, other APAC Distributors, India, Japan and Korea.

The Europe, Middle East and Africa region sales increased 7% with units similar to prior year, due to sales growth in our distributor markets and direct markets.

The Americas region sales increased

11%, with unit increase of 9%, due primarily to sales growth in the U.S.

Changes in foreign currency unfavorably impacted ICL sales by $1.8 million, which impacted our Japan and Europe, Middle East and Africa markets.

ICL sales represented 99.1% of our total sales for fiscal year 2023.

Other product sales include cataract IOLs, delivery systems and normal recurring sales adjustments such as sales return allowances.

As a result of third-party materials and supply chain challenges that affected our cataract IOLs and associated delivery devices, we have phased out sales of our cataract IOLs as we focus on growing our ICL business.

During 2023, we stopped manufacturing cataract IOLs, and we did not sell any cataract IOLs in 2024.

Other product sales for 2024 decreased 55% from 2023, mainly due to decreased sales of cataract IOLs and cataract IOL injector parts, partially offset by increased sales of delivery systems.

Changes in foreign currency unfavorably impacted other product sales by $0.1 million.

Other product sales represented less than 1.0% of our total sales for fiscal year 2024.

Other product sales in 2023 decreased 80% from 2022, mainly due to decreased sales of cataract IOLs and cataract IOL injector parts and increased sales returns reserves related to cataract IOLs.

Changes in foreign currency unfavorably impacted other product sales by $0.3 million.

Other product sales represented 1.0% of our total sales for fiscal year 2023.

Net sales for 2025 included $27.5 million of sales related to the previously disclosed December China Shipment, of which payment was received during 2025.

The composition of our net sales is primarily related to ICL sales.

Net sales also include sales of delivery system sales and normal recurring sales adjustments such as sales return allowances, and for fiscal 2023, IOL sales.

The sales decrease was driven by decreased sales in China.

The Asia Pacific (“APAC”) region, decreased 32% with ICL units down 35%.

The decrease in the APAC region was driven by decreased sales in China, partially offset by sales growth in Japan and Korea.

The Europe, Middle East and Africa (“EMEA”) region sales increased 3% with ICL unit growth up 10%, due primarily to sales increases in our distributor markets partially offset by an increase in sales return allowances in our distributor markets.

The Americas region sales increased 14%, with ICL unit increase of 10%, due primarily to sales growth in the U.S.

Changes in foreign currency favorably impacted net sales by $2.0 million, which impacted our Japan and EMEA markets.

Net sales for 2024 decreased 2.6% from 2023.

The sales decrease was driven by the APAC region, which decreased 6%, with ICL units down 9%.

This decrease was driven by decreased sales in China, primarily related to the $27.5 million December China Shipment, partially offset by sales growth in India, Japan and Korea.

The EMEA region sales increased 9% with ICL unit growth of 17%, due to sales growth in our distributor markets.

The Americas region sales increased 13%, with ICL unit increase of 17%, due primarily to sales growth in the U.S.

Changes in foreign currency unfavorably impacted net sales by $2.8 million, which impacted our Japan and EMEA markets.

The following table presents our gross profit and gross profit margin for the fiscal years presented (dollars in thousands):

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Gross profit for 2025 decreased 23.9% from 2024.

Gross profit margin decreased to 76.2% of revenue for 2025 compared to 76.3% of revenue for 2024, due to higher manufacturing costs per unit due to lower production volume and increased excess and obsolete inventory reserves, offset by decreased period costs as a result of our cost reductions implemented in the quarter ended March 28, 2025 and timing and recognition of the cost of sales associated with the December China Shipment.

Gross profit for 2024 decreased 5.2% from 2023.

Gross profit margin decreased to 76.3% of revenue for 2024 compared to 78.4% of revenue for 2023.

The decrease in gross profit and gross profit margin was primarily due to the recognition of $3.9 million of cost of sales associated with our shipment of $27.5 million of ICLs to one of our distributors in China in the quarter ended December 27, 2024, for which we did not recognize revenue due to extended payment terms with the distributor.

Gross profit and gross profit margin for fiscal 2024 were also negatively impacted by period costs associated with the expansion of the Company’s manufacturing capabilities in its Nidau, Switzerland facility, as well as the temporary idling of its U.S.

The decrease in gross profit margin was primarily due to the recognition of $3.9 million of cost of sales associated with our shipment of $27.5 million of ICLs to one of our distributors in China in the quarter ended December 27, 2024, for which we did not recognize revenue due to extended payment terms with the distributor.

Gross profit margin for fiscal 2024 were also negatively impacted by period costs associated with the expansion of the Company’s manufacturing capabilities in its Nidau, Switzerland facility, as well as the temporary idling of its U.S.

manufacturing facility during the holiday season and for facility upgrades.

Gross profit for 2023 increased 13.1% from 2022.

Gross profit margin increased to 78.4% of revenue for 2023 compared to 78.5% of revenue for 2022, due to reserves related to cataract IOLs and increased period costs associated with manufacturing expansion projects, offset by an increased mix of ICL sales, which carry a higher margin.

General and Administrative Expense

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Percentage of sales

General and administrative expenses for 2025 decreased 4.6% from 2024, due to decreased outside services partially offset by increased bonus and stock-based compensation expenses, salary-related and payroll tax expenses and facilities costs.

General and administrative expenses for 2024 increased 24.3% from 2023, due to increased outside services, facilities costs, salary-related and payroll tax expenses and bonus and stock-based compensation expenses.

General and administrative expenses for 2023 increased 32.1% from 2022, due to increased salary-related and payroll tax expenses, outside services, facilities costs, bonus and stock-based compensation expenses and Japan one-time employee benefits.

Selling and Marketing Expense

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Percentage of sales

Selling and marketing expenses for 2024 increased 0.5% from 2023, due to increased salary-related payroll tax expenses, trade shows and sales meeting expenses, costs and charges associated with the opening of our new EVO Experience Center, sales commission expenses and travel expenses, offset by decreased advertising and promotional activities.

Selling and marketing expenses for 2023 increased 21.4% from 2022, due to increased advertising and promotional activities, salary-related payroll tax expenses, sales commission expenses and travel expenses, partially offset by bonus and stock-based compensation expenses.

Selling and marketing expenses for 2025 decreased 12.4% from 2024, due to decreased advertising and promotional activities, travel expenses and trade shows and sales meetings and as a result of costs and charges in the prior year period associated with the opening of our new experience center, partially offset by increased bonus and stock-based compensation expenses.

Selling and marketing expenses for 2024 increased 4.7% from 2023, due to increased salary-related payroll tax expenses, trade shows and sales meeting expenses, travel expenses, costs and charges associated with the opening of our new experience enter and sales commission expenses, offset by decreased advertising and promotional activities.

Research and Development Expense

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Percentage of sales

Research and development expenses for 2024 increased 21.6% from 2023 due to increased salary-related and payroll tax expenses, purchases of in-process research and development related to external AI tools for measurement and lens size selection and outside services related to professional and medical education, partially offset by decreased clinical expenses associated with our U.S.

post-approval clinical trials.

Research and development expenses for 2023 increased 23.4% from 2022 due to increased salary-related and payroll tax expenses and clinical expenses associated with our U.S.

Research and development expenses for 2025 decreased 11.6% from 2024 due to purchases of in-process research and development in the prior year period related to external AI tools for measurement and lens size selection and decreased clinical expenses associated with our U.S.

post-approval clinical trials and outside services related to regulatory and medical affairs, partially offset by increased bonus and stock-based compensation expenses.

Research and development expenses for 2024 increased 12.0% from 2023 due to increased salary-related and payroll tax expenses, purchases of in-process research and development related to external AI tools for measurement and lens size selection and outside services related to medical affairs, partially offset by decreased clinical expenses associated with our U.S.

post-approval clinical trials.

Research and development expense consist primarily of compensation and related costs for personnel responsible for the research and development of new and existing products, the regulatory and clinical activities required to acquire and maintain product approvals globally and medical affairs expenses.

These costs are expensed as incurred.

Research and development expenses consist primarily of compensation and related costs for personnel responsible for the research and development of new and existing products, quality assurance and post-market surveillance activities, the regulatory and clinical activities required to acquire and maintain product approvals globally and medical affairs expenses.

Research and development expenses associated with the development of new and existing products were $9.6 million, $12.8 million and $8.9 million for fiscal 2025, 2024 and 2023, respectively.

All research and development costs are expensed as incurred.

Merger Transaction and Related Costs

The following table presents professional service expenses we incurred in connection with our proposed Merger with Alcon for the fiscal years presented (dollars in thousands):

Percentage Change

Merger transaction and related costs

Percentage of sales

* Denotes change is greater than + 100%.

During fiscal year 2025, we incurred costs related to our proposed Merger with Alcon, including fees and expenses for legal, financial, communications and proxy advisory services.

At the Special Meeting, the Company’s stockholders voted against the Merger, and the Merger Agreement was terminated in accordance with its terms effective January 6, 2026.

We did not incur any merger transaction and related costs in fiscal years 2024 or 2023.

Restructuring, Impairment and Related Charges

The following table presents our restructuring, impairment and related charges for the fiscal years presented (dollars in thousands):

Percentage Change

Restructuring, impairment and related charges

Percentage of sales

* Denotes change is greater than + 100%.

In the first half of 2025, we took a number of steps to change our leadership team, realign our leadership structure to better address market needs, reduce costs and discretionary spending, and better position the Company to return to sustainable growth.

As part of this leadership realignment and related efforts, during fiscal 2025, we recognized costs

related to severance and reduction in workforce of $12.4 million;

consulting expenses of $0.9 million;

impairment expenses on leasehold improvements and machinery and equipment of $7.7 million, as we will no longer be using these assets;

and impairment on real property right-of-use assets of $4.9 million, as we are actively pursuing subleasing opportunities for two of our leased properties.

In addition, we also recognized impairment of $2.7 million during fiscal 2025, for internally developed software that we will no longer be using as we will transition to a cloud-based software solution.

The restructuring effort was substantially completed as of June 27, 2025.

Other Income, Net

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* Denotes change is greater than + 100%.

Other income, net, increased for 2025 due to foreign exchange gains (primarily euro and Japanese Yen) and a recovery of a previously impaired deposit of $1.5 million, partially offset by decreased interest income as a result of lower balances of investments available for sale and overall lower interest rates.

The change in other income, net for 2024 was due to increased foreign exchange losses (primarily Japanese Yen and euro) and lower interest income as a result of lower balances of investments available for sale.

The change in other income, net for 2023 was due to increased interest income as a result of higher interest rates during 2023.

Other income, net generally relates to interest income earned on cash, cash equivalents and investments available for sale, interest expense on finance lease obligations, gains or losses on foreign currency transactions, and royalty income.

The table below summarizes the year over year changes in other income, net (in thousands):

The table below summarizes the year over year changes in other income, net (dollars in thousands):

Favorable (Unfavorable)

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Net change in other income, net

Provision for Income Taxes

Provision (Benefit) for Income Taxes

The following table presents our provision for income taxes for the fiscal years presented (in thousands):

Percentage Change

Provision for income taxes

Provision (benefit) for income taxes

Effective tax rate

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federal statutory rate of 21% for 2025, 2024 and 2023 respectively, primarily due to the income taxes generated in foreign jurisdictions and realizability of deferred tax assets.

Also impacting our effective tax rates was a $4.5 million recapture of our U.S.

valuation allowance in 2024, $3.3 million recapture of our U.S.

valuation allowance in 2023 and a $0.9 million release of our U.S.

valuation allowance in 2022.

Also during 2024, we recognized $1.5 million of unrecognized benefits, including interest, related to uncertain tax positions taken by us.

There were no unrecognized benefits related to uncertain tax positions taken by us in 2023 or 2022.

Tax benefits of $1.8 million generated in 2025 is mainly due to the loss recognized in the Company’s operation at Switzerland and a favorable uncertain tax position adjustment.

The Company’s operation in Switzerland was profitable in 2024 and 2023 contributing to the majority of tax expense of $11.2 million and $12.3 million, respectively.

The Company has maintained a full valuation allowance position on its U.S.

operation as of fiscal year 2025.

Liquidity and Capital Resources

Our principal sources of liquidity are cash, cash equivalents, investments available for sale and cash flow from operating activities.

Our principal sources of liquidity are cash, cash equivalents, investments available for sale (“AFS”) and cash flow from operating activities.

We believe these sources of liquidity will be sufficient to meet our anticipated cash needs, including working capital needs, capital expenditures and contractual obligations for at least 12 months from the issuance date of the financial statements included in this Annual Report.

We expect that cash flow from operating activities may fluctuate in future periods as a result of a number of factors, including fluctuations in our operating results, working capital needs, capital expenditures, and capital deployment decisions.

We expect that cash flow from operating activities may fluctuate in future periods as a result of a number of factors, including fluctuations in our operating

results, working capital needs, capital expenditures, and capital deployment decisions.

In addition, future capital requirements will depend on many factors including our growth rate in net sales, the timing and extent of spending to support our growth strategy, the expansion of selling and marketing activities, the timing of introductions of new products, as well as global macroeconomic factors.

If our anticipated future cash flow from operating activities is insufficient to satisfy our future capital requirements in the long-term, we may need to seek additional capital.

Our financial condition at December 27, 2024, December 29, 2023 and December 30, 2022 included the following (in thousands):

Our financial condition at January 2, 2026, December 27, 2024 and December 29, 2023 included the following (in thousands):

Cash and cash equivalents

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Cash and cash equivalents include cash and balances in deposits and money market accounts held at banks and financial institutions.

Our investment policy primary objective is capital preservation while maximizing our return on investment.

Our investment policy’s primary objective is capital preservation while maximizing our return on investment.

Investments available for sale may include U.S.

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We do not have any off-balance sheet arrangements.

Our current liquidity and capital resources, as discussed above, will enable us to meet our known contractual obligations as of December 27, 2024 (in thousands):

Our current liquidity and capital resources, as discussed above, will enable us to meet our known contractual obligations as of January 2, 2026 (in thousands):

Payments Due by Period

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More than 5 Years

Finance lease obligations (Note 8)*

Operating lease obligations (Note 9)*

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Overview of changes in cash and cash equivalents and other working capital accounts

The following table presents a summary of cash flows for the fiscal years presented (dollars in thousands):

The following table presents a summary of cash flows for the fiscal years presented (in thousands):

Cash flows from:

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Cash and cash equivalents, at end of year

For 2025, cash provided by operating activities consisted of a net loss of $80.4 million and $16.3 million in working-capital charges primarily related to the capitalization of cloud-based software and changes in inventories and accounts receivable;

partially offset by $62.5 million in non-cash items primarily related to stock-based compensation expenses and impairment of fixed assets and operating lease right-of-use assets.

For 2024, cash provided by operating activities consisted of $44.9 million in non-cash items primarily related to stock-based compensation expenses, partially offset by a $20.2 million net loss and $9.0 million in working-capital changes primarily related to the capitalization of cloud-based software and changes in inventories, partially offset by changes in accounts receivable.

For 2023, cash provided by operating activities consisted of $34.1 million in non-cash items primarily related to stock-based compensation expenses and $21.3 million in net income, offset by $40.8 million in working-capital changes primarily related to changes in accounts receivable and inventories, partially offset by changes in other current liabilities.

For 2022, cash provided by operating activities consisted of $39.7 million in net income and $24.9 million in non-cash items primarily related to stock-based compensation expenses, offset by $28.9 million in working-capital changes primarily related to changes in accounts receivable.

Since 2022 we decided to invest our cash in investments available for sale, in accordance with our investment policy.

For 2023, cash provided by operating activities consisted of $37.3 million in non-cash items primarily related to stock-based compensation expenses and $21.3 million in net income, offset by $44.0 million in working-capital changes primarily related to changes in accounts receivable and inventories.

For 2025, cash provided by investing activities resulted from $124.1 million in proceeds from the maturity of investments available for sale used to supplement working capital, partially offset by $75.4 million in purchases of investments available for sale and $5.8 million in purchases of property, plant and equipment.

For 2024, cash used in investing activities resulted from $80.2 million in purchases of investments available for sale and $23.4 million in purchases of property, plant and equipment, partially offset from proceeds from the sale or maturity of investments available for sale of $43.1 million that was used to supplement working-capital.

For 2023, cash provided by investment activities resulted from proceeds from the sale or maturity of investments available for sale of $143.5 million that was used to supplement working-capital, partially offset by $52.3 million in purchases of investments available for sale and $18.2 million in purchases of property, plant and equipment.

For 2022, cash used in investment activities resulted from $155.7 million in purchases of investments available for sale and $18.1 million in purchases of property, plant and equipment, partially offset by $17.5 million of proceeds from the maturity of investments available for sale.

Our investment in property, plant and equipment during 2025, 2024 and 2023, was primarily due to investments in manufacturing facilities.

For 2025, cash used in financing activities of $4.6 million consisted of $6.5 million of repurchases of common stock pursuant to our share repurchase program and $1.5 million to repurchase employee common stock for taxes withheld, partially offset by proceeds from the exercise of stock options of $3.5 million.

For 2024, cash provided by financing activities of $5.7 million consisted primarily from the exercise of stock options of $7.4 million, partially offset by $1.5 million to repurchase employee common stock for taxes withheld.

For 2023, cash provided by financing activities of $7.4 million consisted primarily from the exercise of stock options of $9.7 million, partially offset by $2.1 million to repurchase employee common stock for taxes withheld.

For 2022, cash provided by financing activities of $8.3 million consisted primarily of proceeds from the exercise of stock options.

Accounts receivable, net was $77.9 million and $94.7 million at December 27, 2024 and December 29, 2023, respectively.

Accounts receivable, net was $50.1 million and $77.9 million at January 2, 2026 and December 27, 2024, respectively.

Days’ Sales Outstanding (DSO) was 85 and 145 days for 2025 and 2024, respectively.

As of December 27, 2024 and December 29, 2023, the Company’s China distributors accounted for 58% and 70%, respectively, of the Company’s consolidated trade receivables.

During fiscal 2024, the Company’s China distributors increased their purchases in anticipation of higher procedural volumes during what is typically a summer “high

season” in China.

As of January 2, 2026 and December 27, 2024, the Company’s China distributors accounted for 33% and 58%, respectively, of the Company’s consolidated trade receivables.

Our DSO is at a normalized level for 2025.

During fiscal 2024, the Company’s China distributors increased their purchases in anticipation of higher procedural volumes during what is typically a summer “high season” in China.

Due to dynamic macroeconomic conditions and other factors, the number of ICL procedures performed during the high season and the second half of 2024 overall was lower than expected.

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Our DSO was higher in 2024, in part, due to the higher levels of purchases by our China distributors during the year and the lower than anticipated procedural volumes.

Our China distributors have made additional payments since December 27, 2024.

Prior to adding a second China distributor in fiscal 2024, we had one distributor in China.

The increase in DSO in 2023 was due to extended payment terms with our China distributor due to unfavorable foreign currency conditions at such time.

We have solid relationships with our distributors in China, and we believe collectability for such accounts receivable balances are reasonably assured.

We do not believe the increases in net accounts receivable reflect a trend, nor that it would have a material impact on cash flows as our available liquidity and capital resources had sufficient working capital despite the increases in net accounts receivable.

Inventories, net was $43.3 million and $35.1 million at December 27, 2024 and December 29, 2023, respectively.

Days’ Inventory on Hand (DOH) was 194 and 142 days for 2024 and 2023, respectively, for finished goods, including consignment inventory.

Inventories, net was $55.5 million and $43.3 million at January 2, 2026 and December 27, 2024, respectively.

Effective in the fourth quarter of 2025, we changed our methodology for calculating Days’ Inventory on Hand (DOH), from using actual cost of sales for the quarter to using the next quarter’s projected cost of sales.

DOH was 219 and 367 days for 2025 and 2024, respectively, for finished goods, including consignment inventory.

In fiscal 2023 and fiscal 2024, we increased our production and inventory to support anticipated sales growth of ICL products and to support quick and efficient delivery and fulfillment for surgical procedures.

In fiscal 2024, due to the macroeconomic and other conditions in China, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory, and accordingly, we reported minimal China ICL sales in the first half of fiscal 2025.

In fiscal 2025, we expanded our manufacturing capabilities for our ICL products in our Nidau, Switzerland facility, which contributed to an increase in inventory.

We also increased inventory in fiscal 2025 to supply consignment inventory in China, to reduce the Company’s tariff risk in China in the near-term.

Increasing our inventory levels also helps mitigate risks associated with potential disruptions to our manufacturing and production process.

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Critical Accounting Estimates

Our accounting policies are more fully described in Note 1 of the Consolidated Financial Statements.

As disclosed in Note 1, the preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make significant estimates and assumptions about future events that affect the amounts reported in the financial statements and accompanying notes.

Our accounting policies are more fully described in Note 1– Organization and Description of Business and Accounting Policies of the Consolidated Financial Statements.

As disclosed in Note 1 – Organization and Description of Business and Accounting Policies, the preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make significant estimates and assumptions about future events that affect the amounts reported in the financial statements and accompanying notes.

Actual results may differ, significantly at times, from these estimates if actual conditions differ from our assumptions.

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In evaluating our ability to recover the deferred tax assets within a jurisdiction from which they arise, we consider all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax-planning strategies, and results of recent operations.

In projecting future taxable income, we begin with historical results and incorporate assumptions including overall current and projected business and industry

conditions, projected sales growth, margins, costs and income by jurisdiction, the amount of future federal, state, and foreign pretax operating income, the reversal of temporary differences and the successful implementation of feasible and prudent tax-planning strategies.

In projecting future taxable income, we begin with historical results and incorporate assumptions including overall current and projected business and industry conditions, projected sales growth, margins, costs and income by jurisdiction, the amount of future federal, state, and foreign pretax operating income, the reversal of temporary differences and the successful implementation of feasible and prudent tax-planning strategies.

These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates management uses to manage its businesses.

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Quantitative and Qualitative Disclosures About Market Risk.

No assurance can be given that adverse currency exchange rate fluctuations will not occur in the future, which could significantly affect our operating results.

can be given that adverse currency exchange rate fluctuations will not occur in the future, which could significantly affect our operating results.

We do not currently hedge transactions to offset changes in foreign currency.

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Activities outside the U.S.

accounted for approximately 94% of our total sales during 2024.

accounted for approximately 91% of our total sales during fiscal 2025.

The results of operations and the financial position of our Japanese subsidiary are reported in Japanese yen and then translated into U.S.

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In addition, we are exposed to transaction risk because we incur some of our sales and expenses in currencies other than the U.S.

Our most significant currency exposures are

to the Japanese yen, the euro, and the Swiss franc, and the exchange rates between these currencies and the U.S.

Our most significant currency exposures are to the Japanese yen, the euro, and the Swiss franc, and the exchange rates between these currencies and the U.S.

dollar may fluctuate substantially.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis