Core Viewpoint - Iridex Corporation is set to release its financial results for Q2 2025 and provide a business update on August 12, 2025, indicating ongoing developments in the company's operations and financial performance [1]. Company Overview - Iridex Corporation is a leader in the development, manufacturing, and marketing of innovative laser-based medical systems and devices for the ophthalmology market [3]. - The company specializes in products for treating glaucoma and diabetic macular edema (DME), utilizing its proprietary MicroPulse® technology for effective laser treatments [3]. - Iridex's products are distributed in over 100 countries, with sales in the U.S. conducted through a direct sales force and international sales through independent distributors [3]. Upcoming Events - A conference call will be held on August 12, 2025, at 2:00 p.m. PT / 5:00 p.m. ET for investors to discuss the financial results and business updates [2]. - Investors can access the call by dialing +1-888-596-4144 with the passcode 2197032, and a live and recorded webcast will be available on the company's website [2].

Core Insights - Iridex Corporation has announced the successful enrollment of the first patient in the DAME Trial, which aims to evaluate the efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments to anti-VEGF therapy for severe diabetic macular edema (DME) [1][2] Company Overview - Iridex Corporation is a leader in developing and marketing innovative laser-based medical systems for ophthalmology, including treatments for glaucoma and retinal diseases [7][8] - The company's proprietary MicroPulse technology minimizes tissue damage while delivering therapeutic benefits, making it a safe and effective treatment option [7] Trial Details - The DAME Trial is an independent, investigator-led study involving at least 20 clinical sites and 264 participants across the UK, focusing on patients with severe DME [2][5] - The trial aims to establish a new treatment pathway by assessing the addition of subthreshold MicroPulse laser therapy after anti-VEGF treatment, specifically when central retinal thickness (CRT) is below 400 μm [2][5] Expected Outcomes - The primary goal of the DAME Trial is to demonstrate equivalence in best-corrected visual acuity outcomes between the two treatment arms over a 24-month period [5] - Secondary outcomes will include quality of life, cost-effectiveness, treatment burden, and patient-reported experiences [5] Significance of the Trial - The DAME Trial could potentially transform the management of DME by reducing the frequency of anti-VEGF injections, thereby lowering associated risks, costs, and patient burden [3][4] - The trial builds on the success of the DIAMONDS study, which previously demonstrated the safety and effectiveness of subthreshold MicroPulse laser treatment for DME [6]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $11,900,000, a slight increase from $11,800,000 in Q1 2024 [17] - Adjusted EBITDA for Q1 2025 was $400,000, an improvement of $2,900,000 compared to an adjusted EBITDA loss of $2,500,000 in Q1 2024 [9][20] - Net loss for Q1 2025 was $1,700,000 or $0.10 per share, compared to a net loss of $3,500,000 or $0.21 per share in the same period last year [20] Business Line Data and Key Metrics Changes - Revenue from the Cyclo G6 glaucoma product family increased by 8% year over year to $3,200,000, driven by higher probe sales [19] - Retina product revenue decreased by 3% to $6,600,000, primarily due to lower PASCAL system sales, partially offset by higher medical and surgical retina system sales [17][18] - Surgical retina sales exceeded expectations, with notable increases in TX product sales, marking the highest volume since Q3 2023 [12] Market Data and Key Metrics Changes - EMEA remains the most stable revenue generator with strong growth potential in the glaucoma segment [14] - In Asia, regulatory approvals for the IRIDEX PASCAL system are driving strong capital equipment sales, particularly in India and Japan [14] - Latin America is stabilizing with clear growth momentum following the approval of IRIDEX PASCAL systems in key markets [14] Company Strategy and Development Direction - The company is focused on innovation and long-term value creation in partnership with Novel Inspiration, aiming to leverage its global customer base and improve operations [15] - Future strategies include optimizing gross margins and exploring partnerships, distribution agreements, or small acquisitions to expand the product portfolio [16] - The company aims to achieve cash flow breakeven and positive adjusted EBITDA results in 2025, contingent on current conditions [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's improved financial condition and operational efficiency, highlighting the positive trajectory towards profitability [6][23] - The company anticipates minimal direct exposure to new tariff policies due to its manufacturing and sourcing primarily within the United States [22] - Management emphasized the importance of maintaining financial discipline and continuing to reduce costs while driving revenue growth [28] Other Important Information - A strategic investment of $10,000,000 from Novel Inspiration was made in March 2025, strengthening the company's balance sheet [7][21] - The company has implemented significant cost reduction measures, resulting in a decrease in operating expenses from $7,800,000 in Q1 2024 to $5,300,000 in Q1 2025 [20] Q&A Session Summary Question: Impact of tariffs on the company - The company expects minimal direct exposure to recent tariff policies as most products are sourced and manufactured in the U.S., providing a pricing and supply chain advantage [24][25] Question: Product extension discussions with Novel - The company is exploring opportunities to expand its product portfolio through distribution agreements, partnerships, or small acquisitions, supported by Novel [26][27] Question: Change in cash burn and achieving cash flow breakeven - Management confirmed that the company is on track to end cash burn, with a significant reduction in operating expenses and a plan to achieve positive adjusted EBITDA and cash flow breakeven this year [28][29]

Financial Data and Key Metrics Changes - The company reported total revenues of $11,900,000 for Q1 2025, a slight increase from $11,800,000 in Q1 2024 [16] - Adjusted EBITDA for Q1 2025 was $400,000, an improvement of $2,900,000 compared to an adjusted EBITDA loss of $2,500,000 in Q1 2024 [19] - The net loss for Q1 2025 was $1,700,000 or $0.10 per share, compared to a net loss of $3,500,000 or $0.21 per share in the same period last year [19] Business Line Data and Key Metrics Changes - Revenue from the Cyclo G6 glaucoma product family increased by 8% year over year to $3,200,000, driven by higher probe sales [16][18] - Retina product revenue decreased by 3% to $6,600,000, primarily due to lower PASCAL system sales, although medical and surgical retina system sales increased [16][18] - Surgical retina sales exceeded expectations, with notable increases in TX product sales, marking the highest volume since Q3 2023 [12] Market Data and Key Metrics Changes - In the EMEA region, strong growth potential in the glaucoma segment was noted, with robust sales of PASCAL systems driving revenue expansion [13] - In Asia, regulatory approvals for the IRIDEX PASCAL system have led to strong capital equipment sales, particularly in India and Japan [13] - The Latin American market is stabilizing with clear growth momentum following the approval of IRIDEX PASCAL systems in key markets [13] Company Strategy and Development Direction - The company is focused on innovation and long-term value creation in partnership with Novel Inspiration, aiming to leverage its global customer base while improving operations [14] - Future strategies include optimizing gross margins in light of new tariff policies and exploring partnerships, distribution agreements, or small acquisitions to expand the product portfolio [15] - The company aims to achieve cash flow breakeven and positive adjusted EBITDA results in 2025, contingent on maintaining current conditions [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's improved financial condition and operational efficiency, highlighting the positive indicators in the business [5][7] - The management team emphasized the importance of driving adoption of differentiated glaucoma and retina technology platforms to create shareholder value [22] - The company expects minimal direct exposure to recent tariff policies due to its manufacturing and sourcing strategy primarily within the United States [21] Other Important Information - A strategic investment of $10,000,000 from Novel Inspiration was made in March 2025, strengthening the company's balance sheet [6][20] - The gross profit for Q1 2025 was $5,100,000, with a gross margin of 42.5%, an increase from 37.9% in Q1 2024 [18] Q&A Session Summary Question: Impact of tariffs on the company - The company expects minimal direct exposure to recent tariff policies as most products are sourced and manufactured in the U.S., providing a pricing and supply chain advantage [23][24] Question: Product extension discussions with Novel - The company is exploring opportunities to expand its product portfolio through distribution agreements, partnerships, or small acquisitions, supported by Novel [25][26] Question: Change in cash burn and achieving cash flow breakeven - The company confirmed it is on track to end cash burn, with a net cash used in operating activities of $1,100,000 in Q1 2025, a decrease of 31% compared to the previous year [27][28]

Core Insights - Iridex Corporation reported a return to year-over-year revenue growth and achieved positive adjusted EBITDA for the first two quarters of 2025, indicating a transformation in operations [3][7] - The company aims to achieve cash flow breakeven and positive adjusted EBITDA in 2025, maintaining revenue generation consistent with 2024 [10] Financial Performance - Total revenue for Q1 2025 was $11.9 million, slightly up from $11.8 million in Q1 2024 [4][9] - Retina product revenue decreased by 3% to $6.6 million, while Cyclo G6 Glaucoma product revenue increased by 8% to $3.2 million [4][9] - Gross profit for Q1 2025 was $5.1 million, representing a gross margin of 42.5%, an increase from 37.9% in Q1 2024 [5] - Operating expenses were reduced by 32% to $5.3 million compared to $7.8 million in Q1 2024 [5][9] - The net loss for Q1 2025 was $1.7 million, or $0.10 per share, an improvement from a net loss of $3.5 million, or $0.21 per share, in the same period of the prior year [7][9] Strategic Developments - The company received a strategic investment of $10 million from Novel Inspiration, which helped to strengthen its balance sheet and settle a note payable [8][9] - Iridex is exploring additional partnerships and distribution agreements to leverage its global customer base [3]

Core Insights - The strategic review process of IRIDEX ended disappointingly, contrary to initial market excitement [1] - The announcement of the strategic review on August 29, 2023, led to a temporary increase in the company's share price [1] Company Analysis - The company has been under scrutiny for its fundamental business and potential upcoming catalysts [1] - The strategic review was anticipated to uncover new opportunities for the company, but the outcome did not meet expectations [1] Market Reaction - There was a notable appreciation in IRIDEX's share price leading up to the strategic review announcement, indicating investor optimism [1]

Company Overview - Iridex Corporation is a global leader in developing, manufacturing, and marketing innovative laser-based medical systems, delivery devices, and consumable instrumentation for the ophthalmology market [3] - The company's proprietary MicroPulse® technology offers a differentiated laser treatment that is safe, effective, and proven for targeted sight-threatening eye conditions [3] - Iridex's product line is utilized for treating glaucoma, diabetic macular edema (DME), and other retinal diseases [3] - Products are sold in the U.S. through a direct sales force and internationally via a network of independent distributors in over 100 countries [3] Upcoming Financial Results - The company plans to release its financial results for the first quarter of 2025 and provide a business update after the close of trading on May 13, 2025 [1] - A conference call will be hosted by the management team at 2:00 p.m. PT / 5:00 p.m. ET on the same day [2] - Investors can access the conference call by dialing +1-888-596-4144 and using conference ID: 698002, with a live and recorded webcast available on the company's website [2]

Group 1 - The conference call is hosted by Trip Taylor, Investor Relations for IRIDEX, with participation from CEO Patrick Mercer and Board member Will Moore, who is one of two new directors appointed after a strategic investment by Novel Inspiration International [3][4]. - The call includes forward-looking statements regarding the company's strategic goals, product development, and market sales trends, which are protected under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 [4][5].

[IRIDEX Corporation Form 8-K Report (April 14, 2025)](index=1&type=section&id=IRIDEX%20Corporation%20Form%208-K) This Form 8-K reports IRIDEX Corporation's preliminary unaudited financial results for the first fiscal quarter of 2025 - IRIDEX Corporation filed this Form 8-K on April 14, 2025, to report preliminary financial results for **Q1 2025**[1](index=1&type=chunk)[4](index=4&type=chunk) - The company's common stock is traded on the Nasdaq Capital Market under the symbol **IRIX**[3](index=3&type=chunk) [Item 2.02. Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) This section announces IRIDEX Corporation's preliminary unaudited financial results for Q1 2025, detailed in an accompanying press release - On April 14, 2025, IRIDEX Corporation announced its preliminary, unaudited operational and financial results for the first fiscal quarter ended **March 29, 2025**[4](index=4&type=chunk) - The press release containing the results is furnished as **Exhibit 99.1** and is incorporated by reference[4](index=4&type=chunk) - The information provided under this item is not considered "filed" for purposes of Section 18 of the Securities Exchange Act of 1934[5](index=5&type=chunk) [Item 9.01. Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits.) This section lists the exhibits filed with the Form 8-K, including the press release detailing financial results and an interactive data file Exhibits Filed with Form 8-K | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release dated April 14, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

Core Insights - Iridex Corporation has announced preliminary unaudited operational and financial results for Q1 2025, indicating a stabilization of the business and improved financial condition following a strategic investment by Novel Inspiration International Co., Ltd [1][3] Financial Performance - Total revenue for Q1 2025 is expected to be between $11.8 million and $12.0 million, consistent with $11.8 million in the same quarter of 2024 [7] - The company sold approximately 13,900 Cyclo G6 probes in Q1 2025, an increase from 13,300 in the prior year quarter [7] - The sales of Cyclo G6 Laser Systems rose to approximately 24 units in Q1 2025, compared to 22 units in the prior year quarter [7] - Cash and cash equivalents as of March 29, 2025, were reported at $7.2 million [7] Strategic Outlook - The company aims to achieve breakeven or better performance at historical revenue levels despite external factors such as changes in tariff policies [3] - An investor call is scheduled for April 16, 2025, to discuss Iridex and Novel's strategic vision for the company [3] Company Overview - Iridex Corporation specializes in developing, manufacturing, and marketing laser-based medical systems and devices for the ophthalmology market, particularly for treating glaucoma and retinal diseases [4] - The company's proprietary MicroPulse® technology offers a differentiated laser treatment for sight-threatening eye conditions [4] - Iridex products are distributed in over 100 countries, primarily through independent distributors [4]