Core Viewpoint - Bausch + Lomb Corporation is under investigation for potential violations of federal securities laws and unlawful business practices following a product recall and subsequent stock price drop [1][2]. Group 1: Product Recall and Impact - On March 27, 2025, Bausch + Lomb announced a voluntary recall of intraocular lenses from its enVista platform due to reports of toxic anterior segment syndrome (TASS), which is a complication associated with cataract surgery [2]. - The recall has raised short-term concerns regarding product safety and may lead to increased regulatory scrutiny [2]. - Following the recall announcement, Bausch + Lomb's stock price fell by $1.50 per share, representing a 10.6% decrease, closing at $15.00 on the same day [2]. Group 2: Legal Investigation - Bragar Eagel & Squire, P.C. is investigating potential claims against Bausch + Lomb on behalf of its stockholders, focusing on possible violations of federal securities laws [1]. - The law firm is reaching out to long-term stockholders who may have suffered losses or have information related to the claims [3].

Core Viewpoint - The Schall Law Firm is investigating Bausch + Lomb Corporation for potential violations of securities laws, focusing on misleading statements and undisclosed information that may have affected investors [1][2]. Financial Performance - Bausch + Lomb reported an adjusted net loss of $54 million for Q1 2025, a significant decline compared to a net income of $24 million in the same period of the previous year [2]. - The company has lowered its full-year growth outlook, attributing part of this change to the recall of its enVista product [2].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Bausch + Lomb Corporation and its executives [1] Group 1: Product Recall and Stock Impact - On March 27, 2025, Bausch + Lomb announced a voluntary recall of intraocular lenses due to reports of toxic anterior segment syndrome, leading to a stock price drop of $1.54 per share, or 9.83%, closing at $14.13 on March 28, 2025 [3] - Following the recall, on April 30, 2025, Bausch + Lomb reported an adjusted net loss of $54 million for Q1 2025, a significant decline from an adjusted net income of $24 million in Q1 2024 [4] - The company revised its full-year growth outlook down to 4.5% to 6.5%, from a previous estimate of 5.5% to 7.5%, citing the impact of the enVista product recall [4] - On the same day, the stock price fell by $2.16 per share, or 15.74%, closing at $11.56 [5] Group 2: Legal Investigation - Pomerantz LLP, a prominent firm in corporate and securities class litigation, is leading the investigation into Bausch + Lomb's practices, emphasizing its long history of fighting for victims of securities fraud [6]

Core Viewpoint - Bausch + Lomb Corporation is under investigation for potential securities fraud and unlawful business practices following significant financial losses and a product recall [1][3]. Financial Performance - Bausch + Lomb reported an adjusted net loss of $54 million for Q1 2025, a stark contrast to an adjusted net income of $24 million in Q1 2024 [3]. - The company has revised its full-year growth outlook to a range of 4.5% to 6.5% year-over-year, down from a previous guidance of 5.5% to 7.5% [3]. Stock Price Movement - Following the announcement of a voluntary recall of intraocular lenses due to toxic anterior segment syndrome, Bausch + Lomb's stock price dropped by $1.54 per share, or 9.83%, closing at $14.13 on March 28, 2025 [2]. - After the release of Q1 2025 financial results, the stock price fell further by $2.16 per share, or 15.74%, closing at $11.56 on April 30, 2025 [4].

[Financial Information](index=15&type=section&id=Part%20I.%20Financial%20Information) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and detailed notes on key financial areas [Condensed Consolidated Financial Statements (Unaudited)](index=15&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) The company reported a net loss of $211 million on revenues of $1,137 million for Q1 2025, with total assets of $13,428 million and liabilities of $6,995 million [Condensed Consolidated Balance Sheets](index=15&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows total assets of $13,428 million and total liabilities of $6,995 million, with a decrease in cash and cash equivalents Condensed Consolidated Balance Sheets (in millions) | (in millions) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $202 | $305 | | Total current assets | $2,694 | $2,788 | | Intangible assets, net | $3,427 | $3,494 | | Goodwill | $4,567 | $4,523 | | **Total assets** | **$13,428** | **$13,469** | | **Liabilities & Equity** | | | | Total current liabilities | $1,726 | $1,738 | | Long-term debt | $4,789 | $4,744 | | **Total liabilities** | **$6,995** | **$6,925** | | **Total equity** | **$6,433** | **$6,544** | [Condensed Consolidated Statements of Operations](index=17&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, revenues increased to $1,137 million, but the company reported an operating loss of $83 million and a net loss of $212 million due to increased operating expenses Condensed Consolidated Statements of Operations (in millions, except per share) | (in millions, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Revenues** | **$1,137** | **$1,099** | | Cost of goods sold | $481 | $423 | | Selling, general and administrative | $563 | $504 | | Operating (loss) income | ($83) | $6 | | Net loss attributable to B+L | ($212) | ($167) | | Basic and diluted loss per share | ($0.60) | ($0.48) | [Condensed Consolidated Statements of Cash Flows](index=20&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $25 million in Q1 2025, with a net decrease of $101 million in cash and cash equivalents during the quarter Condensed Consolidated Statements of Cash Flows (in millions) | (in millions) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($25) | $41 | | Net cash used in investing activities | ($116) | ($57) | | Net cash provided by financing activities | $31 | $12 | | **Net decrease in cash and cash equivalents** | **($101)** | **($9)** | [Note 5: Acquisitions](index=29&type=section&id=Note%205.%20ACQUISITIONS) The company completed several acquisitions in Q1 2025 and 2024, including Whitecap Biosciences, Elios Vision, and Trukera Medical, to expand its pipeline and product portfolios - On January 3, 2025, the company acquired Whitecap Biosciences for an upfront payment of **~$28 million**, which was expensed as acquired in-process R&D costs[68](index=68&type=chunk)[70](index=70&type=chunk) - In December 2024, the company acquired Elios Vision for **~$99 million** in cash plus potential future milestone payments, adding a minimally invasive glaucoma surgery procedure to its portfolio[72](index=72&type=chunk) - In July 2024, the company acquired Trukera Medical for **~$24 million**, expanding its presence in the dry eye market with the ScoutPro osmolarity measurement device[73](index=73&type=chunk) [Note 10: Financing Arrangements](index=38&type=section&id=Note%2010.%20FINANCING%20ARRANGEMENTS) As of March 31, 2025, the company's total long-term debt was $4,881 million with a weighted average interest rate of 7.92%, and it remained in compliance with all debt covenants Long-Term Debt (in millions) | (in millions) | Principal Amount (Mar 31, 2025) | Maturity | | :--- | :--- | :--- | | Revolving Credit Facility | $160 | May 2027 | | May 2027 Term Facility | $2,431 | May 2027 | | May 2027 Incremental Term Facility | $398 | May 2027 | | September 2028 Term Facility | $492 | Sep 2028 | | October 2028 Secured Notes | $1,400 | Oct 2028 | | **Total long-term debt** | **$4,881** | | - The weighted average stated interest rate for outstanding debt was **7.92%** as of March 31, 2025[103](index=103&type=chunk) - As of March 31, 2025, the company was in compliance with its financial covenants[106](index=106&type=chunk) [Note 16: Legal Proceedings](index=47&type=section&id=Note%2016.%20LEGAL%20PROCEEDINGS) The company is involved in various legal proceedings, including antitrust and intellectual property disputes, and has accrued $6 million for probable loss contingencies as of March 31, 2025 - As of March 31, 2025, the company accrued **$6 million** for current loss contingencies from legal matters that are both probable and reasonably estimable[125](index=125&type=chunk) - The company is a defendant in multidistrict antitrust litigation alleging conspiracy to fix prices for generic pharmaceuticals, with Bausch + Lomb and BHC splitting associated costs and liabilities[127](index=127&type=chunk)[129](index=129&type=chunk) - The company faces ongoing patent infringement proceedings against potential generic competitors for key products including Lumify®, Vyzulta®, and Lotemax SM®[145](index=145&type=chunk)[146](index=146&type=chunk)[148](index=148&type=chunk) [Note 17: Segment Information](index=57&type=section&id=Note%2017.%20SEGMENT%20INFORMATION) In Q1 2025, Vision Care was the largest segment with $656 million in revenue and $176 million in profit, while Pharmaceuticals and Surgical segments saw profit declines Segment Performance (in millions) | (in millions) | Revenue Q1 2025 | Revenue Q1 2024 | Segment Profit Q1 2025 | Segment Profit Q1 2024 | | :--- | :--- | :--- | :--- | :--- | | Vision Care | $656 | $635 | $176 | $178 | | Pharmaceuticals | $267 | $267 | $11 | $53 | | Surgical | $214 | $197 | ($7) | $11 | | **Total** | **$1,137** | **$1,099** | **$180** | **$242** | - The top ten products/franchises represented **55%** of total revenues for the three months ended March 31, 2025, up from **54%** in the prior year period[154](index=154&type=chunk) [Management's Discussion and Analysis (MD&A)](index=59&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 3% revenue increase to $1,137 million for Q1 2025, alongside an operating loss of $83 million due to increased costs and an enVista IOL recall, while maintaining sufficient liquidity [Business Overview and Trends](index=59&type=section&id=Business%20Overview%20and%20Trends) The company's business overview highlights its R&D pipeline, the enVista IOL recall, and the monitoring of geopolitical conflicts and global tax changes, with no material impact to date - The company has a global R&D pipeline of over **60 projects**, including new contact lenses, next-generation cataract equipment, and investigational treatments for dry eye[163](index=163&type=chunk) - On March 27, 2025, the company initiated a voluntary recall of certain enVista IOL products due to TASS, with production resuming after identifying a raw material vendor issue[173](index=173&type=chunk)[174](index=174&type=chunk) - Revenues from Russia, Ukraine, and Belarus were approximately **3%** of total revenues for Q1 2025, while the Middle East accounted for less than **1%**, with neither having a material impact to date[179](index=179&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) - The company expects minimal impact to its 2025 tax rate from the new global minimum tax (Pillar Two) but notes a risk of future increases to its overall effective tax rate[191](index=191&type=chunk) [Results of Operations](index=71&type=section&id=Results%20of%20Operations) Q1 2025 revenues grew 3% to $1,137 million, but operating results shifted to an $83 million loss due to increased Cost of Goods Sold and SG&A expenses, leading to a wider net loss Key Financial Results (in millions) | (in millions) | Q1 2025 | Q1 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **$1,137** | **$1,099** | **$38** | **3%** | | Vision Care | $656 | $635 | $21 | 3% | | Pharmaceuticals | $267 | $267 | $0 | 0% | | Surgical | $214 | $197 | $17 | 9% | | **Operating (loss) income** | **($83)** | **$6** | **($89)** | **N/A** | | **Net loss attributable to B+L** | **($212)** | **($167)** | **($45)** | **27%** | - On a constant currency basis, total revenue grew **5%** YoY[212](index=212&type=chunk) - Cost of goods sold increased by **$58 million (14%)**, including a **$15 million** inventory reserve charge related to the enVista IOL recall[221](index=221&type=chunk) - SG&A expenses increased by **$59 million (12%)**, primarily due to higher selling and promotion costs for MIEBO® and increased business transformation costs[224](index=224&type=chunk) [Liquidity and Capital Resources](index=82&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is supported by cash from operations and its revolving credit facility, with total debt of $4,881 million as of March 31, 2025, and recent credit rating upgrades - Net cash used by operating activities was **$25 million** in Q1 2025, a **$66 million** decrease from cash provided in Q1 2024, primarily due to lower operating results and a **$28 million** payment for acquired in-process R&D[243](index=243&type=chunk)[244](index=244&type=chunk) - As of March 31, 2025, the company had total debt principal of **$4,881 million** and **$304 million** of availability under its Revolving Credit Facility[98](index=98&type=chunk)[250](index=250&type=chunk) - Credit ratings were upgraded by S&P to 'B' (Corporate) in March 2025 and by Fitch to 'B' (Corporate) in April 2025[257](index=257&type=chunk)[258](index=258&type=chunk) - For the remainder of 2025, primary cash requirements include **~$320 million** for interest payments, **$30 million** for mandatory debt amortization, and **~$170 million** for capital expenditures[265](index=265&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=99&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to the company's market risk sensitivity assessment have occurred since the 2024 Annual Report, except for interest rate risk - There have been no material changes to the Company's assessment of its sensitivity to market risks, except for interest rate risk, since its last annual report[285](index=285&type=chunk) [Controls and Procedures](index=99&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[286](index=286&type=chunk) - No material changes to internal controls over financial reporting occurred during the first quarter of 2025[288](index=288&type=chunk) [Other Information](index=100&type=section&id=Part%20II.%20Other%20Information) This section provides additional information on legal proceedings and risk factors, noting no material changes since the last annual report [Legal Proceedings](index=100&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings, but management does not anticipate a material adverse effect on its financial position or operations from their ultimate resolution - The company believes that the ultimate resolution of any known legal proceeding will not have a material adverse effect on its financial position, liquidity, or results of operations[290](index=290&type=chunk) - Detailed information on legal proceedings is provided in Note 16 to the Condensed Consolidated Financial Statements[291](index=291&type=chunk) [Risk Factors](index=100&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K have been reported - There have been no material changes to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K[292](index=292&type=chunk)

Core Viewpoint - Bausch + Lomb reported a revenue of $1.14 billion for the quarter ended March 2025, reflecting a 3.5% increase year-over-year, but an EPS of -$0.07, contrasting with $0.07 in the same quarter last year, indicating challenges in profitability despite revenue growth [1]. Revenue Performance - Vision Care revenues reached $656 million, slightly above the average estimate of $654.55 million, marking a year-over-year increase of 3.3% [4]. - Surgical revenues amounted to $214 million, exceeding the average estimate of $206.66 million, with a year-over-year growth of 8.6% [4]. - Pharmaceuticals revenues were reported at $267 million, below the average estimate of $284.94 million, showing no change year-over-year [4]. - Total product sales were $1.13 billion, compared to the average estimate of $1.15 billion, reflecting a year-over-year increase of 3.6% [4]. - Other revenues were reported at $4 million, below the average estimate of $5 million, indicating a significant year-over-year decline of 20% [4]. Stock Performance - Bausch + Lomb shares have returned -2.7% over the past month, in contrast to the Zacks S&P 500 composite's -0.2% change, suggesting underperformance relative to the broader market [3]. - The stock currently holds a Zacks Rank 2 (Buy), indicating potential for outperformance in the near term [3].

Group 1 - Bausch + Lomb reported a quarterly loss of $0.07 per share, missing the Zacks Consensus Estimate of $0.03, and compared to earnings of $0.07 per share a year ago, representing an earnings surprise of -333.33% [1] - The company posted revenues of $1.14 billion for the quarter ended March 2025, missing the Zacks Consensus Estimate by 0.86%, and this is an increase from year-ago revenues of $1.1 billion [2] - Bausch + Lomb shares have declined approximately 24% since the beginning of the year, while the S&P 500 has decreased by 5.5% [3] Group 2 - The earnings outlook for Bausch + Lomb is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend for estimate revisions for Bausch + Lomb is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is $0.16 on revenues of $1.27 billion, and for the current fiscal year, it is $0.67 on revenues of $5 billion [7] Group 3 - The Medical Services industry, to which Bausch + Lomb belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Financial Performance - Total reported revenue for Q1 2025 was $1.137 billion, a 3% increase from $1.099 billion in Q1 2024, with a 5% increase on a constant currency basis[4] - GAAP net loss attributable to Bausch + Lomb for Q1 2025 was $212 million, compared to a net loss of $167 million in Q1 2024[13] - Adjusted EBITDA excluding Acquired IPR&D for Q1 2025 was $126 million, down from $180 million in Q1 2024, a decrease of $54 million[16] - Adjusted net income (non-GAAP) for Q1 2025 was $24 million, compared to a loss of $54 million in Q1 2024, resulting in an adjusted EPS of $0.07 versus a loss of $0.15[46] - Total revenues for Q1 2025 were $1,137 million, a 3.5% increase from $1,099 million in Q1 2024, driven by product sales of $1,133 million[45] - The net loss attributable to Bausch + Lomb Corporation for Q1 2025 was $212 million, compared to a net loss of $167 million in Q1 2024, with a diluted loss per share of $0.60 versus $0.48[45] - Adjusted EBITDA (non-GAAP) for Q1 2025 was $98 million, down from $180 million in Q1 2024, reflecting a decrease of 45.6%[50] Segment Performance - Vision Care segment revenue was $656 million, a 3% increase from $635 million in Q1 2024, with a 5% increase on a constant currency basis[9] - Surgical segment revenue was $214 million, a 9% increase from $197 million in Q1 2024, with an 11% increase on a constant currency basis[10] - Pharmaceuticals segment revenue remained flat at $267 million, with a 1% increase on a constant currency basis[11] - Vision Care segment revenue increased to $669 million in Q1 2025, up 5% from $635 million in Q1 2024[51] - Surgical segment revenue grew by 11% to $218 million in Q1 2025, compared to $197 million in Q1 2024[51] - Pharmaceuticals segment revenue remained stable at $269 million in Q1 2025, with a slight increase of 1% from $267 million in Q1 2024[51] Operational Costs - Operating loss for Q1 2025 was $83 million, compared to an operating income of $6 million in Q1 2024, a change of $89 million[12] - Cash flow used in operations for Q1 2025 was $25 million, down from $41 million in Q1 2024[14] - Cost of goods sold (excluding amortization and impairments) increased to $481 million in Q1 2025 from $423 million in Q1 2024, reflecting a 13.7% rise[45] - Selling, general and administrative expenses rose to $563 million in Q1 2025, up from $504 million in Q1 2024, marking an increase of 11.7%[45] - Research and development expenses were $86 million in Q1 2025, slightly up from $82 million in Q1 2024, indicating a 4.9% increase[45] - The company incurred $38 million in restructuring, integration, and transformation costs in Q1 2025, compared to $28 million in Q1 2024[50] Guidance and Future Outlook - Full-year 2025 revenue guidance updated to $5.000 billion - $5.100 billion, reflecting a constant currency growth of approximately 4.5% - 6.5%[18] - Bausch + Lomb's 2025 full-year guidance is based on current management expectations and includes anticipated growth in key products like XIIDRA® and MIEBO®[25] - The company is undergoing a separation from Bausch Health Companies Inc., which may involve transferring equity interests to shareholders, contingent on achieving targeted debt leverage ratios[25] - Future business development transactions may lead to recurring costs related to Acquired In-Process Research and Development (IPR&D) as the company continues to pursue growth opportunities[36] Risks and Challenges - Risks associated with the separation include potential business disruptions, regulatory approvals, and market conditions that may affect the transaction's completion[26] - The anticipated impact of tariffs and global supply chain disruptions is a concern for the company's revenue and expenses moving forward[26] - The company is actively managing the expected impact of inflation and interest rate fluctuations on its financial performance[26] - The voluntary recall of certain enVista® IOL products is expected to affect market supply, with enhanced inspection protocols in place to address quality concerns[26] Financial Metrics and Adjustments - The company reported a total of $191 million in non-GAAP adjustments for Q1 2025, compared to $158 million in Q1 2024[46] - Amortization of intangible assets decreased to $67 million in Q1 2025 from $74 million in Q1 2024[47] - The company utilized constant currency revenue growth metrics to assess performance, indicating that foreign exchange fluctuations can obscure underlying business trends[39] - Management emphasized the importance of adjusted financial metrics for evaluating operational performance and making strategic decisions[38] - The company has excluded costs related to share-based compensation and separation activities from its financial measures to provide clearer insights into operational performance[34]

Core Insights - Bausch + Lomb (BLCO) currently presents a better value opportunity compared to Danaher (DHR) based on various financial metrics and rankings [1][7] Valuation Metrics - BLCO has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while DHR has a Zacks Rank of 3 (Hold) [3] - The forward P/E ratio for BLCO is 18.75, significantly lower than DHR's forward P/E of 25.14, suggesting BLCO is undervalued [5] - BLCO's PEG ratio stands at 0.75, while DHR's PEG ratio is 2.46, further indicating BLCO's better value proposition [5] - BLCO has a P/B ratio of 0.67 compared to DHR's P/B of 2.80, reinforcing the notion that BLCO is more undervalued [6] - BLCO's overall Value grade is B, while DHR's Value grade is D, highlighting the relative attractiveness of BLCO [6]

Patent and Regulatory Environment - As of February 12, 2025, the company owns or exclusively licenses approximately 2,584 granted patents worldwide, with about 465 being U.S. patents[52] - Approximately 78% of the company's issued patents will expire within the next 10 years, with 23 patents set to expire in both 2025 and 2026, and 36 patents in 2027[52] - The company relies on a combination of regulatory and patent rights to protect the value of its investment in product development[51] - The U.S. Hatch-Waxman Act provides non-patent regulatory exclusivity for five years from the first FDA approval of a new drug compound[54] - The company has approximately 127 pending U.S. patent applications, indicating ongoing innovation efforts[52] - The FDA may designate a product as an orphan drug if it treats a disease affecting fewer than 200,000 individuals in the U.S., granting seven years of marketing exclusivity[58] - The company is subject to extensive government regulations regarding the research, development, testing, and marketing of pharmaceutical products and medical devices[63] - Compliance with manufacturing regulations, including good manufacturing practices, is enforced by the FDA and Health Canada[67] - The company faces periodic audits of its facilities by regulatory agencies, ensuring adherence to compliance standards[68] - Price control restrictions on pharmaceutical products are present in many countries where the company operates[69] Workforce and Operations - The company operates in approximately 100 countries with a global commercial team of about 4,300 employees[89] - In the United States, the company has around 1,150 employees dedicated to selling and marketing contact lenses, lens care, consumer eye health, surgical, and prescription pharmaceutical products[90] - The international commercial footprint includes approximately 3,150 employees and a network of distribution partners[90] - As of December 31, 2024, the company had approximately 13,500 employees, with 7,200 in production and 4,300 in sales and marketing[104] - The company launched a new global performance management program in 2024 to enhance employee performance monitoring and alignment[113] Financial Performance and Risks - In 2024, customers accounting for 10% or more of total revenues were McKesson Corporation and Cardinal Health, Inc., each contributing 10%[93] - Approximately 37% of product sales for 2024 are produced in total or in part by third-party manufacturers under manufacturing arrangements[102] - The company’s revenues tend to be weighted toward the second half of the year, with first-quarter sales typically lower due to patient co-pays and deductibles resetting[118] - As of December 31, 2024, the company had $3,441 million in variable rate debt and $1,400 million in fixed rate debt[578] - A 100 basis-points increase or decrease in interest rates would have an annualized pre-tax effect of approximately $34 million on earnings and cash flows[578] - The estimated fair value of the company's fixed rate debt as of December 31, 2024, was $1,449 million[578] - A 1% change in foreign currency exchange rates would impact shareholders' equity by approximately $27 million[577] - The company is exposed to multiple foreign currencies, including the Euro, Chinese yuan, Russian ruble, and Japanese yen[577] - Further strengthening of the U.S. dollar or devaluation of foreign currencies will negatively impact reported revenue and results[577] - If interest rates increase by 100 basis-points, the fair value of fixed rate debt would decrease by approximately $35 million[578] - If interest rates decrease by 100 basis-points, the fair value of fixed rate debt would increase by approximately $31 million[578] - Changes in interest rates could adversely affect the company's earnings and cash flows due to its variable rate debt[578] Compliance and Governance - The company is subject to extensive U.S. federal and state health care marketing and fraud regulations, including the federal False Claims Act and Anti-Kickback Statute, which impose significant compliance obligations[70] - The company must comply with the Health Insurance Portability and Accountability Act (HIPAA) and various state laws regarding the privacy and security of health-related information, which may require substantial costs for compliance[73] - The General Data Protection Regulation (GDPR) imposes strict obligations on the processing of personal data, with potential fines of up to 4% of global annual revenue or €20 million for violations[76] - The company is subject to the Personal Information Protection Law (PIPL) in China, which regulates the transfer of personal data outside of China, effective from March 1, 2023[79] - The regulatory framework for data privacy and security is rapidly evolving, which may lead to increased compliance costs and risks for the company[82] - The company is developing an integrated ESG program to comply with evolving regulations related to environmental, social, and governance matters[86] Corporate Social Responsibility - The ONE by ONE Recycling program has collected over 94 million used contact lenses and related items since its launch in November 2016[117] - The company’s commitment to corporate social responsibility includes initiatives aimed at disease prevention and improving patient outcomes globally[116] Supply Chain and Manufacturing - The company operates 23 manufacturing facilities across 10 countries, including the U.S., Ireland, and China, focusing on specific product categories[98] - The company’s global supply team is actively managing inflationary and supply-chain challenges due to ongoing macroeconomic conditions[103] - The company faces pressures from government authorities and third-party payors to limit or regulate the price of medical products, which can result in lower average realized prices[83]