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]

Core Insights - Iridex Corporation will host a special call on April 16, 2025, to discuss its strategic vision following a recent investment from Novel [1] - The conference call will begin at 2:00 p.m. PT / 5:00 p.m. ET, and investors can participate by dialing 888-596-4144 with conference ID: 9584140 [2] - Iridex is a leader in developing laser-based medical systems for ophthalmology, focusing on treatments for glaucoma and retinal diseases [3] Company Overview - Iridex Corporation specializes in 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 for sight-threatening eye conditions [3] - Iridex's products are marketed in over 100 countries, with a direct sales force in the United States and independent distributors internationally [3]

IRIDEX (IRIX) Q4 2024 Earnings Call March 27, 2025 10:46 PM ET Company Participants Philip Trip Taylor - Investor RelationsPatrick Mercer - CEO & PresidentRomeo Dizon - CFO Operator Hello, and welcome to the Fourth Quarter twenty twenty four Iridex Earnings Conference Call. At this time, all lines have been placed on mute to prevent any background noise. I would now like to turn the call to Trey Taylor of the Investor Relations department. Please go ahead. Philip Trip Taylor Thank you, and thank you all for ...

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $12.7 million, a year-over-year increase from $12.5 million, and a sequential increase of 10% from $11.6 million in Q3 2024 [27] - Gross profit for Q4 2024 was $5.6 million, representing a gross margin of 44.0%, up from $4.9 million and a 39.2% gross margin in the prior year [29] - Net loss for Q4 2024 was $0.8 million or $0.05 per share, compared to a net loss of $3.0 million or $0.18 per share in the same period of the prior year [30] - Total adjusted EBITDA for Q4 2024 was $0.4 million, an improvement of $2.4 million compared to negative $2.0 million in the prior year [30] Business Line Data and Key Metrics Changes - Total product revenue from the Cyclo G6 glaucoma product family was $3.3 million, a 9% increase compared to Q4 2023, with sales of 13,300 probes, up from 12,700 [28] - Retina product revenue was $7.3 million, a decrease of 3% compared to the prior year, attributed to deferral of capital purchases internationally [29] - Other revenue, including royalties and services, was $2.1 million, up from $2.0 million in the prior year, driven by higher service revenue [29] Market Data and Key Metrics Changes - The company noted an improving macroeconomic environment contributing to good sales momentum entering 2025 [27] - The implementation of the LCD in November 2024 has significantly altered the landscape for physicians, limiting the use cases for mixed devices, which is expected to drive increased utilization for IRIDEX [22] Company Strategy and Development Direction - The company is focusing on modernizing its manufacturing process to decrease costs and increase product supply capacity [21] - The strategic investment by Novel Innovations is seen as a recommitment to extend IRIDEX's leadership in ophthalmology, with plans to leverage this investment for business improvement and strategic goals [23][24] - The company aims to capitalize on opportunities created by the LCD and is not planning to return to aggressive spending patterns of the past [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about stabilization and a positive outlook for the business, particularly in the glaucoma segment [8] - The successful implementation of the cost-reduction program has positioned the company to generate positive cash flow from operations [14] - Management indicated that the strategic review process has been well-timed with increased activity in the ophthalmology sector [12] Other Important Information - The company plans to pre-announce Q1 2025 results in April to address insider trading concerns and highlight the undervaluation of the business [35] - The strategic investment by Novel Innovations was made at a price of $2 per share, reflecting a significant premium to the public market pricing [15] Summary of Q&A Session - There was no question-and-answer session during this call [8]

Market Growth and Demand - The global ophthalmology market is experiencing significant growth, driven by an aging population and increasing prevalence of chronic diseases, particularly in glaucoma and retinal disease markets [27]. - There are an estimated 80-100 million candidates for glaucoma treatment worldwide, highlighting a substantial unmet medical need due to limitations of traditional treatment options [28]. - The number of people with diabetes is expected to rise from 463 million in 2019 to 578 million by 2030, with 28.5% of diabetic patients potentially developing diabetic retinopathy [29]. Product Development and Technology - The company’s MicroPulse technology has been clinically proven to be effective and safe for treating glaucoma and retinal diseases, with a growing body of clinical evidence supporting its use [32]. - The Cyclo G6 laser system and MicroPulse P3 delivery device are designed to treat glaucoma by increasing outflow via the uveoscleral pathway [33]. - The PASCAL laser system offers rapid, precise, and minimally traumatic treatments for reducing intraocular pressure (IOP) in open-angle glaucoma [40]. - The EndoProbe family of products is used for endophotocoagulation procedures, addressing conditions such as proliferative diabetic retinopathy and retinal detachments [50]. - The product line includes laser consoles, delivery devices, and single-use disposable probes, allowing for expanded therapeutic capabilities over time [37]. Business Strategy and Growth - The company aims to promote MicroPulse as a credible treatment option while commercializing products that enhance therapeutic outcomes and reduce costs [35]. - The company completed an asset acquisition with a subsidiary of Topcon, indicating a strategy of pursuing organic growth supplemented by acquisitions [36]. - The company has made substantial investments in improving treatments for serious eye diseases, aiming to expand the patient population and reduce treatment side effects [54]. - The company utilizes various marketing programs, including trade shows and collaborations with key opinion leaders, to identify new product ideas and applications [61][62]. Regulatory and Compliance Challenges - The introduction of products in foreign markets requires compliance with various regulatory clearances, which may impose substantial additional costs and burdens [84]. - The company is subject to significant costs to comply with FDA regulations and other laws, which may adversely affect its business and financial condition [86]. - The company has transferred its Canadian Medical Device Licenses to Salient Medical Solutions, which is certified under the Medical Device Single Audit Program, to comply with new Canadian regulations [85]. - The company is subject to unannounced inspections by the FDA to ensure compliance with quality system regulations, which may include subcontractors' manufacturing facilities [81]. - The company’s products are regulated under the Radiation Control provisions, requiring compliance with performance standards and regular reporting to the FDA [82]. - The recent U.S. Supreme Court decision may lead to increased litigation against the FDA, potentially resulting in uncertainties in the regulatory environment affecting the company [83]. Financial and Operational Overview - In 2024, international sales accounted for 53.4% of the company's revenues, indicating a strong global market presence [59]. - The company has received FDA 510(k) clearance for multiple laser systems, including the Iridex IQ laser systems and Cyclo G6 Laser, enhancing its product portfolio [65][77]. - The company holds 68 active United States patents and 94 active international patents, with 12 pending applications in the U.S. and 20 internationally, reflecting a robust intellectual property strategy [70]. - The company has a current R&D team of 10 engineers and regulatory professionals focused on innovative medical products and applications [52]. - The company has a total of 93 full-time equivalent employees as of December 28, 2024, with 45 in operations, 24 in sales and marketing, 10 in research and development, and 14 in finance and administration [91]. - The company has a total of 18 employees engaged in manufacturing activities, ensuring quality control and assurance before product shipment [64]. Competitive Landscape - The company competes with major players in the ophthalmic laser market, including Alcon Inc. and Bausch Health Companies Inc., highlighting the competitive landscape [69]. - The company does not maintain a material level of backlog, and its quarterly results are affected by seasonal factors, particularly lower European sales in the third quarter due to summer vacations [90]. - The company’s ophthalmology products are typically purchased by healthcare providers who bill third-party payers, and government-imposed limits on reimbursement have significantly affected spending budgets for new equipment [87]. - Changes in government regulations or private third-party payers' policies may limit or eliminate reimbursement for procedures using the company's products, potentially impacting its financial condition [88]. - The company relies on third-party suppliers for most components, which may pose risks related to availability and regulatory compliance [68].

MOUNTAIN VIEW, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and procedure probes for the treatment of glaucoma and retinal diseases, today reported financial results for the fourth quarter and full year ended December 28, 2024. Fourth Quarter 2024 Results & Recent Highlights Achieved positive adjusted EBITDA in the fourth quarter of 2024Successfully implemented previously ann ...

Core Viewpoint - Iridex Corporation has successfully closed a strategic investment transaction with Novel Inspiration International Co., Ltd., resulting in $10 million in gross proceeds, with an option for an additional $10 million for future growth initiatives [1][2]. Group 1: Transaction Details - The transaction includes the sale of $6 million in new Series B Preferred Stock and $4 million in convertible notes [2]. - The Series B Preferred and convertible notes were priced at a common stock equivalent of $2.00 per share, with the convertible notes having a three-year term and bearing 12% interest, payable quarterly in common stock [3]. - Iridex and Novel will collaborate on growth initiatives, which may lead to the issuance of an additional $10 million in convertible notes [2][3]. Group 2: Management and Strategic Direction - The transaction concludes a strategic review process, enhancing Iridex's ability to pursue opportunities in advanced laser-based treatments, particularly for glaucoma [4]. - William Moore, a former CEO and board member, will join Iridex's board of directors as part of the transaction [4]. - Romeo Dizon has been appointed as the new Chief Financial Officer, replacing Fuad Ahmad [5]. Group 3: Financial Outlook and Future Plans - Iridex plans to release its fourth quarter and full year 2024 financial results on March 27, 2025, with a special call for investors scheduled for April 2025 [6]. - The proceeds from the transaction will be used to repay a Senior Convertible Promissory Note and for general corporate purposes [4].

MOUNTAIN VIEW, Calif., March 14, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (NASDAQ:IRIX), a worldwide leader providing innovative and versatile laser-based medical systems and delivery devices for the treatment of glaucoma and retinal diseases, today commented on its recent stock price volatility. The company is not aware of any material developments or changes to its operating or financial condition that precipitated the volume and price movements that occurred on March 13, 2025. There have been no mater ...