Guardant Health(GH) - 2025 Q4 - Annual Report
2026-02-19 22:14
Financial Performance - The company has incurred significant losses since inception and may continue to do so, with uncertainty about achieving and maintaining profitability[22]. - The reimbursement landscape is variable and unpredictable, which may lead to revenue adjustments and impact future financial guidance[74]. - The company anticipates ongoing proposals at federal and state levels to reduce healthcare costs and improve coverage, which may impact pricing and reimbursement for its tests[162]. Product Offerings - The Guardant360 CDx test is a 74-gene liquid biopsy test approved by the FDA, providing tumor mutation profiling for cancer patients, and is the market leader in its category[33]. - The Shield blood test is the first FDA-approved blood test for primary colorectal cancer screening, meeting Medicare coverage requirements, and included in the National Comprehensive Cancer Network guidelines[25]. - The company expects to expand its Shield platform into lung cancer screening and multi-cancer detection (MCD), with the Shield MCD test receiving Breakthrough Device designation from the FDA[41]. - The Guardant Reveal test has been expanded to include late-stage therapy response monitoring, leveraging proprietary technology to predict therapy response across all classes[35]. - The Guardant360 Liquid test measures over 740 genes and supports guideline-recommended biomarkers, providing advanced cancer patients with personalized therapy options[34]. - GuardantINFINITY test provides a comprehensive molecular profile of tumors with genotyping coverage of over 800 genes, enhancing biomarker discovery and clinical research[43]. - GuardantOMNI test covers 500 genes and has achieved superior sensitivity for detecting clinically actionable biomarkers compared to the Guardant360 Liquid test[45]. - GuardantINFORM database offers longitudinal biological insights into tumor evolution and clinical outcomes, supporting drug discovery and clinical research[46]. - The Smart Platform enhances research and development efficiencies, driving faster turnaround times and cost savings while providing industry-leading sensitivity[48]. Market Expansion and Partnerships - The company aims to strengthen relationships with biopharmaceutical companies to enhance revenue prospects and support product adoption[27]. - The company is focused on expanding global market access through strategic partnerships and investments in clinical utility[30]. - The company has expanded its international commercial efforts, establishing partnerships in Europe and Asia, including a CE mark for the Guardant360 CDx test[57][58]. - In Japan, the Guardant360 CDx test received national reimbursement approval for patients with advanced or metastatic solid tumor cancers[58]. - The company is actively working to expand coverage among commercial payers, which may lead to increased average revenue per test performed[64][65]. Regulatory Environment - The company currently markets its Guardant360 CDx test and the Shield test under an approved PMA, which is more demanding than the 510(k) premarket notification process[110]. - The PMA process generally takes between one and three years, but may take significantly longer depending on the complexity of the application[112]. - The FDA has 180 days to review a filed PMA, although the review often occurs over a longer period[112]. - The FDA may require post-approval studies or post-market surveillance as a condition of PMA approval to ensure ongoing safety and effectiveness[114]. - The 510(k) clearance process requires manufacturers to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device[104]. - The FDA is required to complete its review of a 510(k) notification within 90 days, but clearance often takes longer[105]. - Class III devices, which pose the greatest risk, are subject to the more rigorous PMA process, which is generally more costly and time-consuming than the 510(k) process[103]. - The FDA may impose significant regulatory fines or penalties for failure to submit the requisite applications for device modifications[108]. - The FDA has proposed reforms to the 510(k) clearance process, which could include increased requirements for clinical data and a longer review period[109]. - The FDA's Breakthrough Devices Program aims to expedite the development and review of medical devices that provide more effective treatment for life-threatening conditions, allowing for more timely access to qualifying devices[120]. - The FDA may require simultaneous approval of companion diagnostics with therapeutic products, ensuring that diagnostics are adequately evaluated for safety and effectiveness[125]. - The EU's new In Vitro Diagnostic Regulation (IVDR) will strengthen market placement rules and enhance post-market surveillance, becoming applicable five years after its publication on May 26, 2022[139]. - Compliance with the essential requirements of the EU In Vitro Diagnostic Medical Devices Directive (IVDD) is necessary for obtaining the CE mark, which is required for marketing in the EU[132]. - The FDA has broad post-market regulatory enforcement powers, including unannounced inspections and potential sanctions for non-compliance, which can significantly impact operational costs[127]. - Legislative proposals regarding the regulation of laboratory developed tests (LDTs) may lead to increased regulatory requirements, potentially affecting the development and commercialization of new tests[122]. - The FDA's enforcement discretion generally applies to in vitro diagnostics used within a single laboratory, but future regulations could impose additional compliance costs[121]. - The EU medical device vigilance system mandates reporting of incidents and corrective actions to mitigate risks associated with in vitro diagnostic medical devices already on the market[134]. - The IVDR introduces a unique identification number for medical devices to improve traceability and facilitate efficient recalls in case of safety risks[139]. Employee and Workforce Diversity - As of December 31, 2025, the company had 2,506 employees, with 2,490 being full-time and approximately 2,278 located in the U.S.[163]. - The workforce was approximately 51% racially/ethnically diverse and 53% female as of December 31, 2025[165]. - For leadership positions, 32% self-identified as racially/ethnically diverse and 40% self-identified as women[165]. - Women held 33% of the independent director seats on the company's Board as of December 31, 2025[165]. - The company is committed to recruiting and retaining a diverse team aligned with its values[166]. Compliance and Legal Matters - The company is subject to federal fraud and abuse laws, including the Anti-Kickback Statute and the False Claims Act, which impose significant compliance obligations[150][154]. - In January 2022, the company received a civil investigative demand from the U.S. Attorney for the Northern District of California regarding billing for its genetic tests[157]. - The company is subject to evolving data privacy and security laws that govern the collection and protection of health-related personal information[158]. Financial Position - As of December 31, 2025, the company had cash, cash equivalents, restricted cash, and marketable debt securities totaling $1.3 billion[535]. - The majority of the company's revenue is generated in the United States, with an insignificant amount from foreign currencies as of December 31, 2025[536]. - A hypothetical 10% change in foreign currency exchange rates would not be material to the company's financial condition or results of operations[536]. - The company has not entered into any hedging arrangements regarding foreign currency risk to date[536]. - A hypothetical 100 basis point increase or decrease in interest rates would have resulted in an immaterial decline or increase in the fair value of the company's investments[535]. Employee Engagement and Compensation - Employee engagement surveys are regularly utilized to assess the effectiveness of employee development and compensation programs[166]. - The company offers a comprehensive total rewards package, including market-competitive pay, equity grants, and various insurance benefits[167]. - The compensation programs are evaluated with an independent consultant to ensure competitiveness and fairness across the workforce[166]. - The company maintains a focus on strategic alignment of talent and performance rewards while managing costs[167].
Tenaris S.A.(TS) - 2025 Q4 - Annual Report
2026-02-20 00:30
FORM 6 - K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Report of Foreign Private Issuer Pursuant to Rule 13a - 16 or 15d - 16 of the Securities Exchange Act of 1934 As of February 18, 2026 TENARIS, S.A. (Translation of Registrant's name into English) 26, Boulevard Royal, 4th floor L-2449 Luxembourg (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or 40-F. Form 20-F ✓ Form 40-F ___ Date: February 18, 2 ...
Mirion Technologies(MIR) - 2025 Q4 - Annual Report
2026-02-19 22:06
Table of Contents Mirion Technologies, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 1218 Menlo Drive Atlanta, Georgia 30318 (Address of Principal Executive Office) (770) 432-2744 (Registrant's telephone number, including area code) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended Decembe ...
CSG Systems International(CSGS) - 2025 Q4 - Annual Report
2026-02-19 22:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____ TO _____ Commission File Number 0-27512 CSG SYSTEMS INTERNATIONAL, INC. (Exact name of registrant as specified in its charter) Delaware 47-0783182 (State or ...
LKQ (LKQ) - 2025 Q4 - Annual Report
2026-02-19 21:59
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ———————————————————— FORM 10-K ———————————————————— (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-42002 ________________________________________ LKQ CORPORATION (Exact name ...
DT Midstream(DTM) - 2025 Q4 - Annual Report
2026-02-19 21:54
Operational Performance - The LEAP phase 4 expansion was placed into service in September 2025, increasing system capacity to approximately 2.1 Bcf/d[48] - For the year ended December 31, 2025, average throughput from the Gathering segment was 3.1 Bcf/d, up from 2.9 Bcf/d in 2024[52] - Revenue from the Gathering segment accounted for approximately 45% of consolidated revenue for the year ended December 31, 2025[52] - Approximately 57% of Gathering segment revenue was generated under firm revenue contracts, while 36% came from flowing gas for the year ended December 31, 2025[51] - The company gathered record high volumes on the Haynesville System during the year ended December 31, 2025, and completed expansions on Blue Union Gathering and Tioga Gathering[55] Capital Expenditures and Investments - Capital expenditure investments for ongoing expansion projects are included in the forecasted capital expenditures discussed in the Form 10-K[56] Regulatory Compliance and Environmental Impact - The company operates natural gas storage facilities in Michigan, regulated by PHMSA, and must comply with federal safety standards[92] - PHMSA's new regulations may expand requirements for underground natural gas storage facilities, with a final rule expected in January 2025[92] - The company incurs significant costs for compliance with U.S. federal and state pipeline safety laws, but does not expect these costs to materially affect its financial condition[88] - Civil penalties for pipeline safety violations can reach up to approximately $272,926 per day, with a maximum of $2.73 million for a series of violations[89] - The company is subject to various environmental laws and regulations, which require compliance and can lead to significant costs for pollution control and remediation[94][97] - Future expenditures related to environmental compliance are difficult to estimate due to changing regulations and potential new contamination sites[99] - The company has implemented programs to ensure compliance with environmental laws, incurring significant costs in the process[97] - New PHMSA rules could lead to increased operational costs, but some initiatives may be deregulatory in nature[86] - The company is in substantial compliance with existing environmental laws, but future regulations may impose additional costs[100] - The company may face civil and criminal fines for leaks or ruptures in its pipeline system, which could also lead to operational shutdowns[91] - The company generates materials classified as "hazardous substances" under CERCLA, potentially leading to joint and several liability for cleanup costs[102] - The company is subject to strict requirements under RCRA for the generation, storage, and disposal of hazardous wastes, which may increase future capital expenditures and operating expenses[103] - The company may incur significant costs for air pollution control equipment to comply with the Clean Air Act and state regulations, impacting operational costs[105] - Legislative measures addressing climate change and GHG emissions could increase environmental compliance costs, potentially affecting the company's financial condition[107] - The EPA's final rule regulating GHG emissions from oil and gas production includes performance standards and emission guidelines, with compliance deadlines extended to December 3, 2025[107] - The company is not currently aware of any facts that could materially adversely affect its business related to hazardous waste cleanup requirements[104] - Compliance with the Clean Water Act and state laws may result in delays and increased costs for obtaining necessary permits for discharges into regulated waters[113] - The company believes that compliance with existing and foreseeable new permit requirements will not materially adversely affect its financial condition[114] - The Endangered Species Act may impose additional costs and operational restrictions if new species are designated as endangered, but current compliance has not posed material costs[119] - The company is subject to OSHA regulations aimed at protecting worker health and safety, with new requirements potentially increasing compliance costs[120] - The company is in substantial compliance with all applicable laws and regulations relating to worker health and safety, but future compliance costs may materially affect financial condition and results of operations[121] Financial Performance and Asset Management - The company monitors estimates and assumptions regarding future cash flows and may need to write down goodwill if projected results are revised downward due to market factors[287] - No indicators of impairment were identified for long-lived assets during 2025, indicating stable asset performance[289] - Depreciation and amortization are based on estimated useful lives, which may change due to economic conditions and supply and demand[290] - The company assesses equity method investments for impairment and did not identify any indicators of impairment during 2025[291] Regulatory Operations - Regulatory operations are subject to rate regulation by FERC, with rates set to recover costs based on demand and competition[292] - Regulatory accounting is followed for certain transactions, and the company believes all regulatory assets and liabilities are recoverable in the current environment[292]
Bunge SA(BG) - 2025 Q4 - Annual Report
2026-02-19 21:53
TABLE OF CONTENTS INDEX TO CONSOLIDATED FINANCIAL STATEMENTS ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 Or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ____________________________________________________________________________ FORM 10-K Commission File Number 000-56607 BU ...
Lakeside Holding Limited(LSH) - 2026 Q2 - Quarterly Report
2026-02-19 21:52
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 001-42140 Lakeside Holding Limited (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...
Gentherm(THRM) - 2025 Q4 - Annual Report
2026-02-19 21:52
Revenue and Customer Base - Gentherm's revenues from its two largest customers, Lear Corporation and Adient plc, were $234 million and $164 million, representing 16% and 11% of total product revenues, respectively[46]. - In 2025, the top two customers, Lear and Adient, accounted for 16% and 11% of product revenues, respectively, while General Motors and Volkswagen each represented 12% of product revenues[63]. - Product revenues by OEM for 2025 show Volkswagen and General Motors at 12%, BMW at 9%, and Ford at 8%, reflecting a competitive landscape[47]. - In 2025, 66% of product revenue was generated from sales to customers outside the United States, including Europe and Asia[85]. - Over 15% of 2025 product revenue was generated from sales to customers in China, amid ongoing U.S.-China trade tensions[86]. Business Segments and Strategy - The company is organized into two reportable segments: Automotive and Medical, focusing on climate and comfort solutions in automotive and patient temperature management in the medical sector[18][19]. - Gentherm's automotive products include Climate Control Seats, Climate Control Interiors, and Lumbar and Massage Comfort Solutions, which are designed to enhance passenger comfort[14][27]. - Gentherm's strategy emphasizes profitable growth, operational excellence, and financial performance, leveraging core technologies to expand into new markets such as home and office, power-sports, and commercial vehicles[36][39]. - The automotive segment represents 97% of product revenues for the years ended December 31, 2025, 2024, and 2023, indicating a strong reliance on the automotive industry[73]. Financial Performance - For the year ended December 31, 2025, product revenues increased by 2.9% to $1,498,602 thousand compared to $1,456,124 thousand in 2024[191]. - Operating income for the year ended December 31, 2025, was $82,700 thousand, a decrease of $24,315 thousand from $107,015 thousand in 2024[191]. - The company reported a net income of $18,285 thousand for 2025, down from $64,947 thousand in 2024, reflecting a decline of $46,662 thousand[191]. - The cost of sales increased to $1,136,426 thousand in 2025 from $1,089,693 thousand in 2024, resulting in a gross margin decrease to $362,176 thousand[191]. - The company’s net research and development expenses rose to $94,759 thousand in 2025, compared to $88,697 thousand in 2024[191]. Operational Challenges - The company is subject to intense competition, particularly from Chinese-based component suppliers, which could impact pricing and margins[62]. - Seasonal fluctuations in automotive vehicle production are expected, particularly during summer and December, affecting operational performance[52]. - The global automotive supply chain has been adversely impacted by raw material shortages and manufacturing disruptions, which are expected to continue affecting profitability[77]. - The company’s ability to manage new product launches effectively is critical, as delays or quality issues could lead to significant financial penalties[70]. Research and Development - The company is committed to research and development, focusing on innovative products and partnerships to enhance energy utilization and production efficiencies[20][21]. - Gentherm's core technologies include thermal management, air moving devices, pneumatic solutions, and advanced valve systems, which are applicable across various end markets[22][23][25][26]. Mergers and Acquisitions - The company is pursuing a Reverse Morris Trust transaction with Modine Manufacturing Company, which involves the transfer of Modine's Performance Technologies business and the merger of SpinCo into Gentherm[16][17]. - The Modine Transaction is subject to conditions including shareholder approval and regulatory approvals, and failure to complete it could adversely impact the market price of the company's Common Stock[131]. - The integration of Performance Technologies following the Modine Transaction may present significant challenges, potentially affecting the combined company's business and financial condition[134]. Risks and Compliance - The company faces risks related to data privacy and security laws, which could lead to significant penalties and operational costs if not complied with[106]. - Regulatory changes, including tariffs and trade policies, could materially affect the company's operations and financial results, particularly in relation to supply chain costs and demand[104]. - The company is subject to extensive regulation in its patient temperature management business, with potential costs associated with compliance and inspections[116]. Capital Structure and Liquidity - As of December 31, 2025, the company's total consolidated indebtedness was $189.1 million, with $307.9 million available for additional borrowings under the Second Amended and Restated Credit Agreement[122]. - The company expects to incur significant one-time costs related to the Modine Transaction, which may include transaction-related fees and expenses, potentially impacting liquidity and cash flows[137]. - The company utilizes strategies to manage global liquidity needs, with $103.1 million in cash and cash equivalents held by non-U.S. subsidiaries as of December 31, 2025[126]. Shareholder Information - Current shareholders will experience substantial dilution in the Merger, with pre-Merger shareholders owning approximately 60% of the issued and outstanding shares of Common Stock on a fully diluted basis post-Merger[141]. - The company has not paid any cash dividends since formation and does not expect to pay any in the foreseeable future[161]. - The company authorized a stock repurchase program of up to $150.0 million over a three-year period, expiring June 30, 2027, with $10.0 million repurchased in 2025[162].
Fidelity National Financial(FNF) - 2025 Q4 - Annual Results
2026-02-19 21:50
FNF Reports Fourth Quarter and Full Year 2025 Financial Results Jacksonville, Fla. – (February 19, 2026) - Fidelity National Financial, Inc. (NYSE:FNF) (FNF or the Company), a leading provider of title insurance and transaction services to the real estate and mortgage industries and a leading provider of insurance solutions serving retail annuity and life customers and institutional clients through its majority-owned, publicly traded subsidiary F&G Annuities & Life, Inc. (NYSE:FG) (F&G), today reported fina ...