What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-19 compared with 2025-11-12 · 51 added, 78 removed, 67 unchanged (66% of the section changed)

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IRIDEX is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures used to treat sight-threatening eye conditions, including glaucoma and retinal diseases.

Our propriety MicroPulse ® Technology and Endpoint Management Technology are used for the treatment of glaucoma and retina disorders.

Our proprietary MicroPulse ® Technology and Endpoint Management Technology are used for the treatment of glaucoma and retina disorders.

Both technologies are offered as optional treatment modes in select laser consoles in addition to the standard continuous-wave (“CW”) treatment mode.

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CW laser photocoagulation can stabilize vision over the long term but can also result in varying degrees of vision loss.

Both MicroPulse and Endpoint Management technologies have demonstrated clinical efficacy with a safer profile compared to standard high-energy CW laser for the treatment of both retinal diseases and glaucoma.

Both MicroPulse and Endpoint Management technologies have demonstrated clinical efficacy with a safer profile compared to standard high-energy CW laser for the treatment of retinal diseases and glaucoma.

Our products consist of laser consoles, delivery devices and consumable probes.

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In the offices and clinics, ophthalmologists use our laser systems with either an indirect laser ophthalmoscope or a slit-lamp adapter.

Our proprietary MicroPulse® and Continuous Wave laser therapies for glaucoma have been adopted by physicians around the globe as effective tools for managing and slowing the progression of glaucoma.

Our products are sold in the United States and Germany predominantly through a direct sales force and internationally (aside from Germany, Italy, UK (Glaucoma), India, and other smaller markets) primarily through Topcon Corporation (“Topcon”) and other independent distributors.

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Sales to direct end users transacted through our German office are denominated in Euros and are subject to risks associated with currency fluctuations.

Our overall manufacturing strategy is to continuously develop and refine our processes to achieve our objectives of continuity of supply, quality of supply and margin enhancement.

Over time, this may lead to in-sourcing or outsourcing certain functions in various geographic locations to achieve our objectives.

Cost of revenues consists primarily of our direct manufacturing costs which include the cost of components and sub-systems, assembling, packaging, shipping and testing components at our facility, direct labor and associated overhead, warranty, royalty and amortization of intangible assets and depot service costs.

For certain of the Company ’ s products, the Company is responsible for the cost of the fully assembled product that is manufactured by a third-party.

For certain of our products, we are responsible for the cost of the fully assembled product that is manufactured by a third-party.

Research and development expenses consist primarily of personnel costs, materials to support new product development and research support provided to clinicians at medical institutions developing new applications which utilize our products and regulatory expenses.

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Impact of Macroeconomic Conditions to our Business

Current macroeconomic conditions exhibit challenges that can affect capital equipment purchasing demand and timing, including recessionary fears, inflation concerns, tariffs and retaliatory responses, trade wars, lapse in government funding, healthcare reform initiatives, heightened interest rates as a result of government actions to combat inflation, and uncertainty in the global banking and financial services market, as well as other geopolitical developments, have impacted and may continue to impact business spending and the economy as a whole.

As a result, the Company has seen customers extend purchase decision cycles.

dollar strengthens again, the Company could experience some demand softness due to pricing effects from the strength of the U.S.

Current macroeconomic conditions exhibit challenges that can affect capital equipment purchasing demand and timing, including recessionary fears, tariffs and retaliatory responses, trade wars, conflicts in the Middle East, lapse in government funding, healthcare reform initiatives, unexpected changes in taxes or policies, inflation concerns, changing interest rates, as well as other geopolitical developments and uncertainty, have impacted and may continue to impact business spending and the economy as a whole.

As a result, we have seen customers extend purchase decision cycles.

The macroeconomic conditions on our business and operations remain uncertain, and it is not possible for us to predict the duration and extent to which they will affect our business, future results of operations, and financial condition.

For more information on risks associated with the current macroeconomic conditions, see the sections titled “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 28, 2024.

Results of Operations

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Three Months Ended

Nine Months Ended

September 27, 2025

September 28, 2024

September 27, 2025

September 28, 2024

April 4, 2026

March 29, 2025

Cost of revenues

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Provision for income taxes

The following comparisons are between the three months ended September 27, 2025 and September 28, 2024 (in thousands):

The following comparisons are between the three months ended April 4, 2026 and March 29, 2025 (in thousands):

Three Months Ended

September 27, 2025

September 28, 2024

Total revenues

Our total revenues increased by $0.9 million, or 7.8%, from $11.6 million to $12.5 million.

All of our product groups increased, led by probe sales in the glaucoma product group and system sales in the retina product groups.

While we believe that the market for our products remains strong, the overall capital expenditure landscape within hospitals, surgical centers and physician offices may continue to be negatively impacted by persistent macroeconomic concerns, including those from ongoing geopolitical uncertainty, tariffs and trade wars.

Gross Profit and Gross Margin

Gross profit decreased $0.3 million, or 7.2% from $4.3 million to $4.0 million.

Gross margin decreased by 5.2% from 37.3% to 32.1%.

The decrease in gross margin was driven by a $0.8 million loss on inventory write down, partially offset by shift to more favorable geographic and product mix.

Gross margins may fluctuate due to changes in the relative proportion of domestic and international sales, the product mix of sales, introduction of new products, manufacturing variances, total unit volume changes, responses to the evolving macroeconomic and geopolitical uncertainty, including tariffs and trade wars, and other factors.

Research and Development

Research and development expenses decreased by $0.3 million, or 25.2% from $1.3 million to $1.0 million.

The decrease was related to our cost savings measures we implemented, resulting in lower headcount expenses.

Spending on investment in new and expanded products was also curtailed.

Sales and Marketing

Sales and marketing expenses remained relatively flat, though we continued realizing cost savings from lower headcount and being disciplined with our expenses.

General and Administrative

General and administrative expenses decreased by $0.4 million, or 20.2% from $2.2 million to $1.8 million.

The decrease was a primarily due to a decrease in consulting costs.

Other Expense, Net

Other expense, net was $158 thousand for the three months ended September 27, 2025 compared to $46 thousand for the three months ended September 28, 2024.

Other expense, net, consisted primarily of interest income or expense and foreign currency gain or loss.

The Company recorded an income tax provision of $4 thousand and $17 thousand for the three months ended September 27, 2025 and September 28, 2024, respectively.

The following comparisons are between the nine months ended September 27, 2025 and September 28, 2024 (in thousands):

Nine Months Ended

September 27, 2025

September 28, 2024

April 4, 2026

March 29, 2025

Total revenues

Our total revenues increased by $2.0 million, or 5.5%, from $36.0 million to $38.0 million.

All of our product groups increased, led by probe sales in the glaucoma product group and system sales in the retina product groups.

Our total revenues decreased by $0.1 million, or 0.8%, from $11.9 million to $11.8 million.

Revenue in our glaucoma and other revenue product groups increased, partially offset by a decrease in our retina products.

Gross Profit and Gross Margin

Gross profit decreased $0.1 million, or 1.2%, from $13.9 million to $13.8 million.

Gross profit decreased by $0.3 million, or 6.2% from $5.0 million to $4.7 million.

Gross margin decreased by 2.3% from 42.5% to 40.2%.

The decrease in gross margin was driven by a $0.8 million loss on inventory write down, partially offset by shift to more favorable geographic and product mix.

The decrease in gross margin was primarily due to higher manufacturing costs and increased product costs related to recent tariff developments as the Company continues its transition to lower-cost contract manufacturers.

Gross margins may fluctuate due to changes in the relative proportion of domestic and international sales, the product mix of sales, introduction of new products, manufacturing variances, total unit volume changes, responses to the evolving macroeconomic and geopolitical uncertainty, conflicts in the Middle East, including tariffs and trade wars, and other factors.

Research and Development

Research and development expenses decreased by $1.6 million, or 37.3%, from $4.3 million to $2.7 million.

The decrease was related to our cost savings measures we implemented, resulting in lower headcount expenses.

Spending on investment in new and expanded products was also curtailed.

Research and development expenses remained relatively flat at $0.9 million.

This reflects management’s continued focus on cost saving initiatives, including reduced spending on new and expanded product investments.

Sales and Marketing

Sales and marketing expenses decreased by $2.2 million, or 22.6%, from $9.9 million to $7.6 million.

The decrease was related to our cost savings measures, resulting in lower headcount expenses, consulting expenses, travel expenses, tradeshows and public relations expenses, and clinical studies expenses.

Sales and marketing expenses remained relatively flat at $2.5 million.

This also reflects management’s continued focus on cost saving initiatives and maintaining stable spending levels within this function.

General and Administrative

General and administrative expenses decreased by $0.3 million, or 16.0% from $1.9 million to $1.6 million.

The decrease was a primarily due to a decrease in consulting costs and deal related legal expenses.

Other Expense, Net

Other expense, net, was $1.7 million for the nine months ended September 27, 2025, driven primarily by the costs associated with the settlement of the Lind Note.

Other expense, net, was $0.2 million for the nine months ended September 28, 2024, consisting of interest and amortization of loan expenses related to the Lind Note transaction and foreign currency loss.

The Company recorded an income tax provision of $37 thousand and $74 thousand for the nine months ended September 27, 2025 and September 28, 2024, respectively.

The decrease was primarily attributable to lower consulting costs, reduced deal related legal expenses, and cost savings realized from the general and administrative function transfer initiative announced in prior periods.

Other Income (Expense), Net

Other expense, net, was $0.1 million for the three months ended April 4, 2026, primarily consisting of interest and amortization of loan expenses.

Other expense, net, was $1.5 million for the three months ended March 29, 2025, driven primarily by the costs associated with the Lind Note payable settlement.

We recorded an income tax provision of $58 thousand and $12 thousand for the three months ended April 4, 2026 and March 29, 2025, respectively.

Liquidity, Capital Resources and Management Plans

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In addition, liquidity includes the ability to obtain appropriate financing or to raise capital.

As of September 27, 2025, the Company had cash and cash equivalents of $5.6 million and working capital of $11.7 million compared to cash and cash equivalents of $2.4 million and working capital of $7.0 million as of December 28, 2024.

Net cash used in operating activities was $2.7 million in the nine months ended September 27, 2025 compared to net cash used in operating activities of $6.0 million in the nine months ended September 28, 2024.

The decrease in net cash used in operating activities was primarily due to reduction in net loss and reduction in inventory, offset by decreases in collections of accounts receivable and a paydown of liabilities.

For the nine months ended September 27, 2025 and September 28, 2024, net cash used in investing activities was $37 thousand and $4 thousand, respectively, which consisted of capital expenditures.

For the nine months ended September 27, 2025, net cash provided by financing activities was $6.0 million.

The Company received $10 million in issuance of convertible preferred shares and convertible debt, offset by $4.0 million in early prepayment of convertible debt and taxes paid related to net share settlements of equity awards.

For the nine months ended September 28, 2024, net cash $2.8 million was provided by financing activities of issuance of convertible notes, net.

The Company has historically funded our operations primarily through sales of our products to customers, sales of our common stock and borrowing arrangements.

As of September 27, 2025, our principal sources of liquidity consisted of cash and cash equivalents of $5.6 million.

The Company has incurred net losses over the last several years, and as of September 27, 2025, have an accumulated deficit of approximately $92.3 million.

The Company’s purchase commitments consist primarily of non-cancellable purchase commitments with vendors to manufacture certain components and ophthalmic instrumentation.

As of September 27, 2025, the Company’s future minimum payments through fiscal year 2027 for its purchase commitments were approximately $20.7 million, with $12.4 million committed for the next 12 months.

As of April 4, 2026, we had cash and cash equivalents of $4.6 million and working capital of $11.8 million compared to cash and cash equivalents of $6.0 million and working capital of $12.0 million as of January 3, 2026.

Net cash used in operating activities was $1.3 million in the three months ended April 4, 2026 compared to net cash used in operating activities of $1.1 million in the three months ended March 29, 2025.

The increase in net cash used in operating activities was primarily due to increase in loss from operations.

For the three months ended April 4, 2026, net cash used in investing activities was $0.1 million, which consisted of capital expenditures.

For the three months ended March 29, 2025, net cash used in investing activities was $11 thousand, which consisted of capital expenditures.

For the three months ended April 4, 2026, net cash used in financing activities was $1 thousand, primarily related to taxes paid to net share settlement of equity awards.

For the three months ended March 29, 2025, net cash from financing activities was $6.0 million.

In the first fiscal quarter of 2025, we received $10 million in issuance of convertible preferred shares and convertible debt, offset by $4.0 million in early prepayment of convertible debt.

We have historically funded our operations primarily through sales of our products to customers, sales of our common stock and borrowing arrangements.

As of April 4, 2026, our principal sources of liquidity consisted of cash and cash equivalents of $4.6 million.

We have incurred net losses over the last several years, and as of April 4, 2026, have an accumulated deficit of approximately $92.9 million.

On March 19, 2025, the Company entered into the Novel Securities Agreement and the Novel Note Purchase Agreement with Novel.

Pursuant to the Novel Securities Agreement and the Novel Note Purchase Agreement, Novel has the right to purchase additional convertible promissory notes (the “Growth Notes”) in an aggregate principal amount of $10,000,000.

The Growth Notes are

issuable in three installments, with one third of the aggregate principal amount issuable upon each yearly anniversary after March 19, 2025.

The Company believes its existing cash and cash equivalents will be sufficient to meet its anticipated cash needs over the next 12 months.

The Company’s future capital requirements will depend on many factors, including its growth rate, the timing and extent of its spending to support research and development activities, the timing and cost of establishing additional sales and marketing capabilities, the introduction of new and enhanced products and its costs to implement new manufacturing technologies.

Any debt financing obtained by the Company in the future could also involve restrictive covenants relating to its capital-raising activities and other financial and operational matters, which may make it more difficult for the Company to obtain additional capital and to pursue business opportunities, including potential acquisitions.

Additionally, if the Company raises additional funds through further issuances of equity, its existing stockholders could suffer significant dilution in their percentage ownership of the Company, and any new equity securities the Company issues could have rights, preferences and privileges senior to those of holders of our common stock.

The Growth Notes are issuable in three installments, with one third of the aggregate principal amount issuable upon each yearly anniversary after March 19, 2025.

We have not issued any Growth Notes, but may do so in the future.

We believe our existing cash and cash equivalents will be sufficient to meet our anticipated cash needs over the next 12 months.

Our future capital requirements will depend on many factors, including our growth rates, the timing and extent of our spending to support research and development activities, the timing and cost of establishing additional sales and marketing capabilities, the introduction of new and enhanced products and our costs to implement new manufacturing technologies.

In the event that additional financing is required from outside sources, we may not be able to raise it on terms acceptable to us or at all.

Any debt financing obtained by us in the future could also involve restrictive covenants relating to our capital-raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.

Additionally, if we raise additional funds through further issuances of equity, our existing stockholders could suffer significant dilution in their percentage ownership of our company, and any new equity securities we issue could have rights, preferences and privileges senior to those of holders of our common stock.

If we are unable to obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability to continue to grow or support our business and to respond to business challenges could be significantly limited.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Quantitative and Qualitat ive Disclosure about Market Risk

As a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act, the Company is not required to provide the information called for by this Item.

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Quantitative and Qualitat ive Disclosures about Market Risk

As a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act, we are not required to provide the information called for by this Item.

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-Q

Item 2. Management’s Discussion and Analysis