MOUNTAIN VIEW, Calif., Dec. 18, 2024 (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 announced the publication of a landmark peer-reviewed study in Ophthalmology Therapy. This study highlights the sustained safety and efficacy of MicroPulse Transscleral Laser Therapy (TLT) (also referred to as Transscleral Cyclophotocoagulation) in managing b ...

Core Viewpoint - Iridex Corporation's new Local Coverage Determination (LCD) L37531, effective November 17, 2024, is expected to enhance physician interest in its laser-based glaucoma treatments, as it clarifies that Iridex's products are not classified as Micro-Invasive Glaucoma Surgery (MIGS) procedures, thus exempting them from new reimbursement limitations [1][2][3]. Group 1: Company Overview - Iridex Corporation is a leader in developing and marketing innovative laser-based medical systems for treating glaucoma and retinal diseases [5][6]. - The company sells over 50,000 Cyclo G6 probes annually, indicating strong market penetration and product adoption [2]. Group 2: Impact of the New LCD - The new LCD clarifies that treatments using Iridex's laser consoles and probes are not classified as MIGS, allowing the Cyclo G6 product family to remain unaffected by reimbursement limitations [2][3]. - The LCD is expected to create reimbursement advantages for Iridex's glaucoma treatments, potentially increasing the adoption of its MicroPulse Transscleral Laser Therapy (MPTLT) among physicians [3][4]. - The LCD outlines specific reimbursement limitations, including that MIGS is not a first-line treatment for mild to moderate glaucoma and prohibits simultaneous procedures involving MIGS and aqueous shunts [4]. Group 3: Physician Perspectives - Physicians have expressed the importance of having coverage for various glaucoma treatments, emphasizing the value of Transscleral Cyclophotocoagulation (TSCPC) as a versatile therapy [3]. - Feedback from the recent American Academy of Ophthalmology conference indicates a growing interest among physicians in increasing the use of Iridex's MicroPulse and Continuous Wave therapies [4].

MOUNTAIN VIEW, Calif., Nov. 04, 2024 (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 announced the Company will release financial results for the third quarter 2024 and provide a business update after the close of trading on Tuesday, November 12, 2024. The Company’s management team will host a corresponding conference call ...

Leadership Changes - Iridex Corporation appointed Patrick Mercer as the new Chief Executive Officer and President effective October 1, 2024, succeeding David Bruce [1] - Scott Shuda was appointed as Executive Chairman of the board of directors, having previously served as Chairman [1] Strategic Review Process - The board believes that the leadership change could accelerate progress towards a transaction under the strategic review process initiated last year [2] - The company is currently engaged in discussions with multiple entities regarding potential transactions [2] Company Overview - Iridex is a leader in developing and marketing laser-based medical systems for ophthalmology, focusing on treatments for glaucoma and retinal diseases [4] - The company's proprietary MicroPulse® technology offers safe and effective treatments for sight-threatening eye conditions [4] - Iridex products are distributed in over 100 countries, with a direct sales force in the United States and independent distributors internationally [4]

Strategic Review and Asset Sale - The company initiated a strategic review a year ago to unlock shareholder value, with the ultimate goal of selling its assets [1] - Despite initial expectations, no asset sale agreements have been reached as of late August 2024 [1] - The company remains committed to selling its assets, as evidenced by management restructuring to focus on strategic alternatives [5] Challenges and Investor Concerns - A major hurdle was a reimbursement issue, which was resolved in the company's favor but delayed the asset sale process [1] - Investor concerns include impatience with management's ability to close a deal, potential equity issuance for capital, and doubts about finding interested buyers [3][4] - The stock price has fallen back to pre-strategic review levels, reflecting investor frustration [2] Financial Sustainability and Recent Developments - The company's glaucoma business is a money-loser, while its retina business is profitable [6] - In early August, the company secured a convertible note financing, providing $3.5M in immediate liquidity and an additional $1.5M if needed, ensuring financial stability during the strategic review [6] - The financing strengthens the company's bargaining position with potential acquirers [6] Potential Asset Sale Scenarios - Selling the entire company at once could result in a quicker sale but potentially at a lower total share price [9] - Selling the profitable retina business first could significantly increase the share price, while retaining the glaucoma business for future potential [9] - Selling the glaucoma business first would provide immediate financial stability, as the retina business is cash-flow positive [9] Valuation and Expectations - The retina business is estimated to generate an annual net profit of $10M, with a potential valuation of $60-80M (6-8x multiple) [10] - The glaucoma business is estimated to have a $10M annual revenue run rate, with a potential valuation of $25M, though this may decrease due to delays in the strategic review [10] - Initial expectations for a total sale price of $6.00/share or more have been revised to $3.50-$4.50/share, reflecting the prolonged strategic review process [10] Conclusion and Outlook - The company remains serious about selling its assets, with management restructuring and financial measures in place to support the process [11] - The CEO expects an agreement for the sale of certain assets by the end of 2024 [7] - Patient investors could see a doubling of the current share price within the next 3-6 months, driven by the underlying value of the retina division [11]

Financial Performance - Iridex reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.12, representing an earnings surprise of -33.33% [1] - The company posted revenues of $12.63 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 1.32%, and down from $12.86 million a year ago [2] - Over the last four quarters, Iridex has surpassed consensus EPS estimates only once and has not beaten consensus revenue estimates during the same period [2] Stock Performance - Iridex shares have declined approximately 35.2% since the beginning of the year, contrasting with the S&P 500's gain of 9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.10 on revenues of $12.6 million, and for the current fiscal year, it is -$0.49 on revenues of $50.4 million [7] Industry Outlook - The Lasers Systems and Components industry, to which Iridex belongs, is currently ranked in the bottom 17% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Iridex's stock may be influenced by the overall outlook for the industry, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

MOUNTAIN VIEW, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- IRIDEX Corporation ("Iridex", or the "Company") (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 announced it has executed definitive agreements related to a private placement financing (the "Financing") of a senior convertible promissory note (the "Initial Note") with Lind Global Asset Management IX LLC, an ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2024 was $11.8 million, down $1.9 million from the prior year period, primarily due to loss of royalty revenue and continued softness in capital equipment purchases [34][38] - Gross profit for Q1 2024 was $4.5 million, compared to $5.9 million in the prior year, with a gross margin of 37.9%, down from 43.3% [21][22] - The net loss for Q1 2024 was $3.5 million or $0.25 per share, compared to a net loss of $2.1 million or $0.13 per share for the same period in 2023 [22] Business Line Data and Key Metrics Changes - In the glaucoma segment, Cyclo G6 revenue was $3.0 million, down from $3.7 million in Q1 2023, with 13,300 G6 probes sold, representing a 4% sequential growth from Q4 2023 [6][9] - Retina product revenue was $6.8 million, a decrease of 6% compared to Q1 2023, driven by lower medical and surgical system sales, partially offset by higher PASCAL system revenue [7][20] Market Data and Key Metrics Changes - The company experienced longer sales cycles and capital equipment purchase deferrals, impacting overall revenue [5][34] - There was a noted softness in U.S. probe sales, with concerns over potential reimbursement changes affecting new system purchases [32][41] Company Strategy and Development Direction - The company is focused on executing business line growth strategies to drive adoption of both retina and glaucoma technologies, with a refreshed product portfolio generating customer interest [14][15] - IRIDEX is actively engaged in a strategic review process, exploring potential transactions to unlock value for stockholders [29][13] Management Comments on Operating Environment and Future Outlook - Management acknowledged ongoing market headwinds but expressed confidence in the company's strong market position and the potential for revenue recovery driven by stabilized reimbursement for glaucoma procedures [15][17] - There are expectations for continued improvement in environmental factors affecting the business, with indications of firming orders in the second quarter [31][17] Other Important Information - Operating expenses in Q1 2024 were $7.8 million, down from $8.3 million in the same period last year, due to planned cost reduction initiatives [37] - Cash and cash equivalents totaled $5.4 million as of March 30, 2024, with a net cash reduction of $1.6 million in the quarter [38] Q&A Session Summary Question: Inquiry about future potential transactions and M&A appetite - Management confirmed that discussions with other parties are ongoing following the termination of a previous asset sale process, focusing on uncovering strategic value [24] Question: Clarification on G6 probe utilization and international strength - Management noted strength in international sales of G6 probes, with a stabilization in U.S. probe sales, but acknowledged lingering concerns over reimbursement affecting new adoption [25][27] Question: Outlook for 2024 revenue guidance - Management indicated that while they are not providing specific revenue guidance, there is an expectation of recovery and growth if current trends continue [43][45] Question: Cash balance and accounts payable outlook - Management expects cash burn to be materially lower in 2024 compared to 2023, with a typical cash usage of $1.5 million to $2 million per quarter [48][49]

Iridex (IRIX) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.12. This compares to loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -75%. A quarter ago, it was expected that this medical laser company would post a loss of $0.05 per share when it actually produced a loss of $0.18, delivering a surprise of -260%. Over the last four quarters, the company has surp ...

[First Quarter 2024 Financial Results Overview](index=1&type=section&id=1.%20First%20Quarter%202024%20Financial%20Results%20Overview) This section provides an overview of Iridex Corporation's Q1 2024 financial performance, including key highlights and CEO commentary [Executive Summary and Key Highlights](index=1&type=section&id=1.1.%20Executive%20Summary%20and%20Key%20Highlights) Iridex Corporation reported its financial results for the first quarter ended March 30, 2024, showing a decrease in total revenue and specific product lines compared to the prior year, alongside a reduction in cash and cash equivalents Q1 2024 Financial Highlights (YoY Comparison) | Metric | Q1 2024 | Q1 2023 | Change | Source | | :-------------------------------- | :------ | :------ | :----- | :----- | | Total Revenue | $11.8M | $13.7M | -13.9% | chunk_6 | | Cyclo G6 Product Family Revenue | $3.0M | $3.7M | -18.9% | chunk_6 | | Cyclo G6 Probes Sold | 13,300 | 13,800 | -3.6% | chunk_6 | | Cyclo G6 Glaucoma Laser Systems Sold | 22 | 61 | -63.9% | chunk_6 | | Retina Product Revenue | $6.8M | ~$7.2M | -5.6% | chunk_6, chunk_7 | | Cash and Cash Equivalents (as of March 30, 2024) | $5.4M | N/A | -$1.6M (QoQ) | chunk_6 | [CEO Commentary and Business Update](index=1&type=section&id=1.2.%20CEO%20Commentary%20and%20Business%20Update) CEO David Bruce noted continued longer sales cycles and capital equipment purchase deferrals in Q1, anticipating Q2 firming, highlighting new retina product interest and ongoing strategic review - Longer sales cycles and end-of-quarter capital equipment purchase deferrals continued into Q1 2024, impacting revenue[4](index=4&type=chunk) - Expectations for Q2 include additional firming and shipment of queued orders, indicating potential recovery[4](index=4&type=chunk) - Solid growth from Pascal® scanning laser systems and G6 probes internationally was offset by deferrals and revenue declines in other products[5](index=5&type=chunk) - New Iridex 532® and 577® single spot laser platforms for retina are generating customer interest, expected to convert into revenue in upcoming quarters[5](index=5&type=chunk) - The company is continuing an active strategic review process, with discussions ongoing with multiple parties for specific product lines and the entire company, following a failed initial asset sale transaction[5](index=5&type=chunk) [Detailed First Quarter 2024 Financial Performance](index=2&type=section&id=2.%20Detailed%20First%20Quarter%202024%20Financial%20Performance) This section provides a detailed analysis of Iridex Corporation's revenue, gross profit, operating expenses, net loss, and cash position for Q1 2024 [Revenue Analysis](index=2&type=section&id=2.1.%20Revenue%20Analysis) Total revenue for Q1 2024 decreased by **13.9%** year-over-year, primarily due to lower system sales and reduced royalties from expired patents Q1 2024 Revenue Breakdown (YoY Comparison) | Revenue Category | Q1 2024 ($M) | Q1 2023 ($M) | YoY Change (%) | Primary Drivers | | :--------------- | :----------- | :----------- | :------------- | :-------------- | | Total Revenues | 11.8 | 13.7 | -13.9% | Lower system sales, decreased royalties | | Retina Product Revenue | 6.8 | 7.2 | -5.6% | Lower medical/surgical system sales, partially offset by higher Pascal system sales | | Cyclo G6 Product Group Revenue | 3.0 | 3.7 | -18.9% | Lower system sales, lower U.S. probe sales partially offset by international probe sales rebound | | Other Revenue | 2.0 | 2.8 | -28.6% | Decreased royalties (patent expiration), lower service revenue | [Gross Profit and Operating Expenses](index=2&type=section&id=2.2.%20Gross%20Profit%20and%20Operating%20Expenses) Gross profit and margin declined in Q1 2024 due to lower revenue, while operating expenses decreased overall, despite increased legal costs from the strategic review Q1 2024 Gross Profit and Margin (YoY Comparison) | Metric | Q1 2024 | Q1 2023 | Change | Driver | | :----------- | :------ | :------ | :----- | :----- | | Gross Profit | $4.5M | $5.9M | -23.7% | Lower overhead absorption across reduced revenue base | | Gross Margin | 37.9% | 43.3% | -5.4 pp | Lower overhead absorption across reduced revenue base | Q1 2024 Operating Expenses (YoY Comparison) | Metric | Q1 2024 ($M) | Q1 2023 ($M) | YoY Change ($M) | Primary Drivers | | :-------------------- | :----------- | :----------- | :-------------- | :-------------- | | Total Operating Expenses | 7.8 | 8.3 | -0.5 | Cost reduction initiatives, partially offset by increased legal expenses | | Legal Expenses (increase) | N/A | N/A | +0.4 | Related to strategic review process | [Net Loss and Earnings Per Share](index=2&type=section&id=2.3.%20Net%20Loss%20and%20Earnings%20Per%20Share) Iridex reported an increased net loss of **$(3.5) million** and a higher net loss per share of **$(0.21)** for Q1 2024 compared to the prior year Q1 2024 Net Loss and EPS (YoY Comparison) | Metric | Q1 2024 | Q1 2023 | Change | | :------------- | :------ | :------ | :----- | | Net Loss | $(3.5)M | $(2.1)M | $(1.4)M | | Net Loss Per Share | $(0.21) | $(0.13) | $(0.08) | [Cash and Cash Equivalents](index=2&type=section&id=2.4.%20Cash%20and%20Cash%20Equivalents) The company's cash and cash equivalents decreased by **$1.6 million** during the first quarter of 2024, reaching **$5.4 million** Cash and Cash Equivalents | Metric | As of March 30, 2024 | Cash Use in Q1 2024 | | :-------------------- | :------------------- | :------------------ | | Cash and Cash Equivalents | $5.4M | N/A | | Cash Use | N/A | $1.6M | [Condensed Consolidated Financial Statements](index=4&type=section&id=3.%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated statements of operations and balance sheets for Iridex Corporation [Statements of Operations](index=4&type=section&id=3.1.%20Statements%20of%20Operations) The unaudited condensed consolidated statements of operations show decreased total revenues and gross profit, leading to an increased net loss for Q1 2024 Condensed Consolidated Statements of Operations (Unaudited) | (In thousands, except per share data) | Three Months Ended March 30, 2024 | Three Months Ended April 1, 2023 | | :------------------------------------ | :-------------------------------- | :------------------------------- | | Total revenues | $11,761 | $13,706 | | Cost of revenues | 7,303 | 7,768 | | Gross profit | 4,458 | 5,938 | | Operating expenses: | | | | Research and development | 1,536 | 1,749 | | Sales and marketing | 3,747 | 4,283 | | General and administrative | 2,468 | 2,250 | | Total operating expenses | 7,751 | 8,282 | | Loss from operations | (3,293) | (2,344) | | Other income (expense), net | (133) | 266 | | Loss from operations before provision for income taxes | (3,426) | (2,078) | | Provision for income taxes | 38 | 12 | | Net loss | $(3,464) | $(2,090) | | Net loss per share: | | | | Basic | $(0.21) | $(0.13) | | Diluted | $(0.21) | $(0.13) | | Weighted average shares used in computing net loss per common share: | | | | Basic | 16,253 | 16,001 | | Diluted | 16,253 | 16,001 | [Balance Sheets](index=5&type=section&id=3.2.%20Balance%20Sheets) The unaudited condensed consolidated balance sheets show a slight decrease in total assets and stockholders' equity, with increased total liabilities from Q4 2023 to Q1 2024 Condensed Consolidated Balance Sheets (Unaudited) | (In thousands) | March 30, 2024 | December 30, 2023 | | :------------------------------------ | :------------- | :---------------- | | **ASSETS** | | | | Current assets: | | | | Cash and cash equivalents | $5,419 | $7,034 | | Accounts receivable, net | 9,146 | 9,654 | | Inventories | 11,003 | 9,906 | | Prepaid expenses and other current assets | 2,010 | 856 | | Total current assets | 27,578 | 27,450 | | Property and equipment, net | 265 | 351 | | Intangible assets, net | 1,558 | 1,642 | | Goodwill | 965 | 965 | | Operating lease right-of-use assets, net | 2,402 | 2,632 | | Other long-term assets | 1,324 | 1,396 | | **Total assets** | **$34,092** | **$34,436** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Current liabilities: | | | | Accounts payable | $7,991 | $4,727 | | Accrued compensation | 2,256 | 1,619 | | Accrued expenses | 1,112 | 1,996 | | Other current liabilities | 1,265 | 1,233 | | Deferred revenue, current | 2,447 | 2,404 | | Operating lease liabilities, current | 995 | 995 | | Total current liabilities | 16,066 | 12,974 | | Long-term liabilities: | | | | Deferred revenue | 9,708 | 10,025 | | Operating lease liabilities | 1,526 | 1,751 | | Other long-term liabilities | 304 | 164 | | **Total liabilities** | **27,604** | **24,914** | | Stockholders' equity: | | | | Common stock | 172 | 172 | | Additional paid-in capital | 88,838 | 88,444 | | Accumulated other comprehensive loss | (16) | (52) | | Accumulated deficit | (82,506) | (79,042) | | **Total stockholders' equity** | **6,488** | **9,522** | | **Total liabilities and stockholders' equity** | **$34,092** | **$34,436** | [Additional Company Information](index=2&type=section&id=4.%20Additional%20Company%20Information) This section provides background on Iridex Corporation, details on its Q1 2024 webcast, a safe harbor statement, and investor relations contact information [About Iridex Corporation](index=2&type=section&id=4.1.%20About%20Iridex%20Corporation) Iridex Corporation is a global leader in laser-based medical systems for ophthalmology, specializing in glaucoma and retinal diseases, utilizing its proprietary MicroPulse® technology - Iridex Corporation develops, manufactures, and markets innovative laser-based medical systems, delivery devices, and consumable instrumentation for the ophthalmology market[11](index=11&type=chunk) - The company's proprietary MicroPulse® technology provides safe, effective, and proven treatment for sight-threatening eye conditions[11](index=11&type=chunk) - Current product lines treat glaucoma, diabetic macular edema (DME), and other retinal diseases, sold directly in the U.S. and through distributors internationally in over 100 countries[11](index=11&type=chunk) [Webcast and Conference Call Details](index=2&type=section&id=4.2.%20Webcast%20and%20Conference%20Call%20Details) Iridex hosted a conference call and webcast on May 14, 2024, to discuss its Q1 2024 financial results - A conference call was hosted on May 14, 2024, at 2:00 p.m. PT / 5:00 p.m. ET[10](index=10&type=chunk) - Investors can access the live and recorded webcast on the 'Event Calendar' page of the 'Investors' section of the Company's website at www.iridex.com[10](index=10&type=chunk) [Safe Harbor Statement](index=2&type=section&id=4.3.%20Safe%20Harbor%20Statement) This statement cautions that forward-looking statements are not guarantees of future performance, and actual results may differ materially due to various risks - The announcement contains forward-looking statements concerning clinical expectations, commercial trends, market adoption, value-maximizing transactions, and product demand[13](index=13&type=chunk)[14](index=14&type=chunk) - These statements are not guarantees of future performance, and actual results may differ materially due to various risks[14](index=14&type=chunk) - The company cannot provide assurance that it will complete any value-maximizing transactions for its stockholders[14](index=14&type=chunk) - A detailed description of risks is available in the Annual Report on Form 10-K filed on March 29, 2024[14](index=14&type=chunk) [Investor Relations](index=3&type=section&id=4.4.%20Investor%20Relations) Contact information for investor relations inquiries is provided - Investor Relations Contact: Philip Taylor, Gilmartin Group, investors@iridex.com[15](index=15&type=chunk)