Sales and Revenue - STAAR Surgical Company generated approximately 100% of its net sales from implantable Collamer lenses (ICLs) for the fiscal year ended December 27, 2024[18]. - For the fiscal year ended December 27, 2024, 94% of STAAR's worldwide revenue was generated from product sales outside the United States[19]. - Other Products revenue accounted for less than 1% of total sales in fiscal 2024, indicating a strong focus on ICLs[30]. - In fiscal 2024, net sales to China distributors were $161.3 million, accounting for 51.4% of consolidated net sales, a decrease from 57.6% in fiscal 2023[41]. - The company generated approximately 94% of its total sales outside the U.S. in 2024[144]. - Net sales decreased in fiscal 2024 compared to fiscal 2023, but the company intends to return to sales growth[161]. Product Development and Market Position - STAAR has sold more than 3,000,000 ICLs worldwide as of March 2024, marking a significant milestone for the company[25]. - The company plans to continue developing and launching innovative products to meet clinical needs and customer demands[28]. - STAAR's EVO ICL is the only posterior chamber phakic IOL approved by the U.S. FDA, contributing to its position as the world's largest selling phakic IOL[24]. - The incidence of myopia is projected to affect nearly 5 billion people by 2050, driving demand for refractive procedures[27]. - STAAR's marketing programs aim to position ICL products as a premium option for patients, supported by surgeon education and training initiatives[28]. - Future growth depends on timely development of new ophthalmic products that are accepted by physicians and patients[169]. - Extensive clinical trials required for new products are expensive and have uncertain outcomes, potentially delaying market entry[171]. Manufacturing and Inventory - STAAR maintains significant manufacturing capabilities in California and Switzerland, with ongoing expansions to meet forecasted demand[21]. - Finished goods inventory as of December 27, 2024, was $43.3 million, representing 194 Days' Inventory on Hand (DOH)[43]. - The company has increased inventory levels to mitigate risks associated with potential disruptions in manufacturing and production processes[43]. - The company is expanding its manufacturing capabilities in Nidau, Switzerland, which involves significant risks and uncertainties[140]. - The company is vulnerable to disruptions at its principal manufacturing facility in Monrovia, California[140]. Competition and Market Challenges - Competition in the ophthalmic surgical product market is intense, driven by technological innovation and regulatory approvals[45]. - The company’s ICL technology competes with laser vision correction procedures, which are a significant alternative for consumers[46]. - The company faces intense competition from larger companies and low-cost Asian manufacturers in the ICL market[148]. Regulatory Compliance and Risks - Regulatory requirements for medical devices vary widely by country, impacting the time and cost of obtaining market clearance[56]. - The company’s ICL products are classified as Class III devices, requiring a more rigorous PMA approval process to demonstrate safety and effectiveness[62]. - The FDA's review of a PMA application typically takes between six and twelve months, but may extend significantly based on additional information requests[63]. - The company is subject to regular inspections by Notified Bodies in the US and Switzerland to ensure compliance with medical device regulations[74]. - The FDA may impose severe penalties for non-compliance, including revocation of approvals and potential criminal sanctions[69]. - The company is subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (FCPA), which could result in significant penalties for non-compliance[193]. - Changes in U.S. FDA or international regulations could adversely affect the company's competitive position and financial results[187]. Financial and Operational Risks - The company’s pension plans are underfunded by approximately $6.7 million as of December 27, 2024[152]. - The company may incur substantial expenses due to compliance with data protection and privacy regulations[157]. - The company is subject to risks associated with acquisitions, including integration difficulties and unknown liabilities[159]. - The company does not carry insurance for interruptions or potential losses arising from earthquakes or terrorism[143]. - Increased manufacturing, sales, and marketing expenses may exceed expectations, impacting financial condition[162]. - Climate changes and extreme weather conditions could disrupt operations and increase manufacturing costs[166]. - Relationships with healthcare professionals are subject to scrutiny under healthcare compliance laws, which could lead to penalties[182]. - Product recalls could result in lost sales and damage to the company's reputation[184]. Cybersecurity and Risk Management - The company has established policies for assessing and managing material risks from cybersecurity threats, integrated into its overall risk management program[207]. - The Audit Committee is responsible for discussing the company's policies regarding risk assessment and management, including cybersecurity risks[209]. - The company utilizes both internal personnel and external service providers to support its cybersecurity efforts[212]. - The CIO collaborates closely with legal, privacy, and internal audit functions to address cybersecurity and data privacy risks[213]. Investor Relations - The closing price of the company's common stock ranged from $23.93 to $52.25 per share during the year ended December 27, 2024[197]. - The largest investor beneficially owns approximately 22% of the outstanding common stock, while the largest three investors own approximately 51%[202]. - The company has not paid any cash dividends on its common stock since inception and does not expect to declare cash dividends in the foreseeable future[198].

Core Viewpoint - STAAR Surgical Company is under investigation for potential securities fraud and unlawful business practices following disappointing financial results for Q4 and full year 2024 [1][2]. Financial Performance - For Q4 2024, STAAR reported GAAP earnings per share of -$0.69, missing consensus estimates by $0.55 [2]. - The company's revenue for the quarter was $48.95 million, which fell short of consensus estimates by $28.52 million [2]. - The company attributed its poor performance to "fluctuating demand in China" [2]. Market Reaction - Following the announcement of the financial results, STAAR's stock price dropped by $5.40 per share, or 24.68%, closing at $16.48 per share on February 12, 2025 [3].

LOS ANGELES, Feb. 13, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of STAAR Surgical Company ("Staar" or "the Company") (NASDAQ: STAA) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Staar reported disappointing earnings for Q4 2024, blaming the results on wea ...

STAAR Surgical Company (NASDAQ:STAA) Q4 2024 Earnings Call Transcript February 11, 2025 5:00 PM ET Company Participants Brian Moore - VP, Investor Relations and Corporate Development Tom Frinzi - Chair of the Board, President and CEO Patrick Williams - CFO Conference Call Participants Iseult Mcmahon - BTIG Tom Stephan - Stifel Anthony Petrone - Mizuho Macauley Kilbane - William Blair Patrick Wood - Morgan Stanley Steve Lichtman - Oppenheimer Jim Sidoti - Sidoti & Co. Phillip Dantoin - Piper Sandler Jon Youn ...

Fourth Quarter and Fiscal 2024 Earnings Presentation February 11, 2025 NASDAQ: STAA STAAR Surgical Earnings Call and Webcast Fourth Quarter and Fiscal 2024 Chair of the Board, President and CEO Chief Financial Officer TOM FRINZI PATRICK WILLIAMS Today's Speakers Investor Relations http://investors.staar.com Brian Moore VP, Investor Relations and Corporate Development Connie Johnson Director, Investor Relations and High-Performance Management Niko Liu, CFA Director, Investor Relations and Corporate Developme ...

STAAR Surgical (NASDAQ: STAA ) announced Q4 results where Q4 revenue of $49 million was down 36% year over year, and well below management's guidance of $77 million. While global revenue ex-China grew strongly by 17% year over year, revenueAn individual investor primarily focused on undercovered companies, with more than 50 companies on my watchlist. My areas include technology, software, electronics and the energy transition. I have been investing my personal capital for over 7 years in a broad range of co ...

Financial Performance - Net sales for fiscal year 2024 were $313.9 million, a decrease from $322.4 million in the prior year, primarily due to weak performance in China[11]. - ICL sales for fiscal year 2024 totaled $312.5 million, down from $319.4 million in the previous year, with ICL sales excluding China increasing by 13% to $151.6 million[11]. - Fourth quarter net sales were $49.0 million, significantly lower than $76.3 million in the prior year quarter, driven by a decline in China revenue[6]. - ICL sales in the fourth quarter were $46.9 million, compared to $74.6 million in the prior year quarter, with ICL sales excluding China up 17% to $39.5 million[4]. - The company reported a net loss of $(20.2) million for fiscal year 2024, compared to net income of $21.3 million in the prior year, resulting in a net loss per share of $(0.41)[13]. - The company reported a net loss of $34,228,000 for the three months ended December 27, 2024, compared to a net income of $7,756,000 for the same period in 2023[32]. - Net income for Q4 2023 was $7,756, a decrease from $21,347 in Q4 2022, resulting in a net loss of $34,228 for Q1 2024[33]. Gross Margin and Expenses - Gross margin for fiscal year 2024 was 76.3%, down from 78.4% in the previous year, and gross profit margin for the fourth quarter was 64.7%, compared to 79.6% in the prior year quarter[12][7]. - Gross profit margin decreased to 64.7% in Q4 2024 from 79.6% in Q4 2023, reflecting a gross profit of $31,648,000 compared to $60,725,000[32]. - Research and development expenses increased by 10.8% to $12,042,000 in Q4 2024, compared to $10,866,000 in Q4 2023[32]. - Selling, general and administrative expenses increased to $59,558,000 in Q4 2024, representing 121.7% of net sales, compared to $50,320,000 in Q4 2023[32]. Cash Flow and Assets - Cash, cash equivalents, and investments available for sale at the end of fiscal year 2024 totaled $230.5 million, slightly down from $232.4 million at the end of the previous year[14]. - Cash and cash equivalents decreased to $144,159,000 as of December 27, 2024, from $183,038,000 as of December 29, 2023[31]. - The company’s total assets increased to $509,524,000 as of December 27, 2024, compared to $488,692,000 as of December 29, 2023[31]. - Cash provided by operating activities for Q4 2023 was $31,969, compared to $642 in Q1 2024, indicating a significant decline[33]. - The company’s cash flows from investing activities showed a net usage of $(19,495) in Q4 2023, contrasting with a net inflow of $22,402 in Q1 2024[33]. Future Projections - For fiscal year 2025, the company expects ICL sales excluding China to be approximately $165 million to $175 million, representing 9% to 15% growth[16]. - China ICL sales are projected to be less than $5 million in the first half of 2025, with a potential rebound to $75 million to $125 million in the second half[16]. - The company anticipates an adjusted EBITDA loss of approximately $(30) million per quarter in the first half of 2025, followed by a gain of $5 million to $22.5 million per quarter in the second half[16]. - The company’s outlook for Q1 2024 includes a projected net income loss of $(63,000) to $(78,000)[34]. Sales Growth by Region - Global ICL sales reached $319,427,000 in 2023, reflecting an 18% growth compared to 2022[35]. - Americas sales increased to $22,233,000 in 2023, with a growth rate of 11% year-over-year[35]. - EMEA sales grew to $39,318,000 in 2023, marking a 7% increase from the previous year[35]. - APAC sales surged to $257,876,000 in 2023, showing a 21% growth compared to 2022[35]. - China sales amounted to $185,404,000 in 2023, with a growth rate of 25%[35]. - ICL sales excluding China totaled $134,023,000 in 2023, reflecting a 10% increase year-over-year[35]. - The company reported a global ICL sales growth of 27% in 2022, followed by an 18% growth in 2023[35]. - The Americas region experienced a significant sales growth of 43% in 2022, which decreased to 11% in 2023[35]. - The company anticipates a continued focus on market expansion and new product development in the upcoming fiscal year[35]. Liabilities and Stock Information - Total liabilities increased to $112,189,000 as of December 27, 2024, from $102,738,000 as of December 29, 2023[31]. - The weighted average shares outstanding for basic shares increased to 49,266,000 in Q4 2024 from 48,815,000 in Q4 2023[32]. - The company reported a stock-based compensation expense of $27,210 for the year ended 2023, up from $23,516 in 2022[33]. - The company experienced a loss on disposal of property and equipment amounting to $1,694 for the year ended 2023[33]. - The provision for sales returns and bad debts was $(1,661) in Q4 2023, compared to $(1,262) in Q4 2022[33]. - The company’s depreciation expense for Q4 2023 was $1,368, with a total of $6,891 for the year[34].

Shares of STAAR Surgical Company (NASDAQ: STAA ) performed poorly last year, mainly owing to weak consumer demand in its largest market, China. Sales of its EVO lenses as an alternative to LASIK surgery have remained strongAn individual investor primarily focused on undercovered companies, with more than 50 companies on my watchlist. My areas include technology, software, electronics and the energy transition. I have been investing my personal capital for over 7 years in a broad range of companies globally. ...

Financial Data and Key Metrics Changes - Total net sales for Q3 2024 increased 10% to $88.6 million, up from $80.3 million in the prior year quarter, primarily due to a $8 million or 10% increase in ICL sales [23][29] - Gross profit was $68.5 million or 77.3% of net sales, compared to $63.6 million or 79.2% of net sales in the prior year, with the decrease in gross margin attributed to reduced unit production [24] - GAAP net income for Q3 2024 was $10 million or $0.20 earnings per diluted share, up from $4.8 million or $0.10 earnings per diluted share in the prior year quarter [29] Business Line Data and Key Metrics Changes - ICL sales increased by 10% year-over-year, contributing significantly to the overall sales growth [23] - Operating expenses for Q3 2024 increased 10% to $62.8 million, reflecting a shift in the timing of some expenditures expected to occur in Q4 2024 [25] - Research and development expense was $14.5 million for Q3 2024, up from $11.5 million in the prior year quarter, primarily due to purchases of in-process R&D related to external AI tools [28] Market Data and Key Metrics Changes - In the Americas, sales growth was 14% in Q3 2024, with U.S. sales growing 16% year-over-year despite the U.S. refractive market being down 18% [17][18] - EMEA region generated 12% sales growth, driven primarily by the Middle East and European distributor markets [19] - APAC region, the largest market for refractive procedures, saw sales growth of 9%, with China sales up 7% [20] Company Strategy and Development Direction - The company is maintaining its financial outlook for fiscal year 2024, anticipating net sales of approximately $340 million to $345 million [11] - The grand opening of the new EVO ICL Experience Center aims to enhance training and education for surgeons, thereby increasing ICL adoption [12][14] - The company is focused on building surgeon confidence in measurement and lens size selection, which is expected to expand the total addressable market [38] Management's Comments on Operating Environment and Future Outlook - Management noted that the macroeconomic environment in China has softened but remains optimistic about the potential impact of recent fiscal policy changes and stimulus [36] - The company is confident in its long-term growth prospects, emphasizing the growing healthcare issue of myopia and the unique advantages of its polymer material [37][38] - Management believes that the current market dynamics are transitory and that STAAR is well-positioned to weather these challenges [36] Other Important Information - The company incurred a $1.6 million non-cash write-off related to its former EVO Experience Center [27] - Cash, cash equivalents, and investments available for sale were $236 million at the end of Q3 2024, providing significant flexibility for capital allocation [30] Q&A Session Summary Question: 2025 growth outlook - Management stated it is premature to comment on 2025 outlook but expressed confidence in the company's ability to outpace the market [42] Question: Trends in China - Management noted that sales tapered off in the second half of the high season but remains optimistic about the impact of government stimulus [44][45] Question: U.S. market penetration - Management highlighted that despite a challenging U.S. refractive market, the company grew 16% and is well-positioned for sustainable growth [50] Question: Competitive landscape in China - Management acknowledged competition but believes their product advantages will maintain a premium position in the market [68]

Staar Surgical (STAA) came out with quarterly earnings of $0.41 per share, beating the Zacks Consensus Estimate of $0.19 per share. This compares to earnings of $0.30 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 115.79%. A quarter ago, it was expected that this maker of implantable lenses would post earnings of $0.25 per share when it actually produced earnings of $0.33, delivering a surprise of 32%.Over the last four quart ...