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ILMN Stock to Gain From the Launch of Illumina Protein Prep Assay
ZACKS· 2025-09-09 13:05
Core Insights - Illumina, Inc. has launched Illumina Protein Prep, an assay aimed at enhancing next-generation sequencing (NGS)-based proteomics discovery, now available globally for researchers [1][2] - The launch follows Illumina's agreement to acquire SomaLogic, which strengthens its position in the proteomics market and supports its multiomics strategy [2][8] - Following the announcement, ILMN shares increased by 2.2%, indicating positive market reception and potential for continued upward momentum [3] Company Developments - Illumina Protein Prep utilizes SomaLogic's SOMAmer technology to measure 9,500 unique human protein targets, facilitating large-scale proteomics studies [5][8] - The company has processed approximately 30,000 samples with the Illumina Protein Prep 6K assay and over 6,000 samples with the 9.5K assay since early access began [6] - Illumina's market capitalization stands at $15.21 billion, with an earnings yield of 4.5%, significantly higher than the industry's -21.7% yield [4] Industry Context - The global proteomics market was valued at $27.8 billion in 2024 and is projected to grow at a CAGR of 12.9% by 2030, driven by the increasing prevalence of chronic diseases and demand for advanced diagnostics [10] - Researchers in the 100,000 Genomes Project have reported a 7.5% increase in diagnostic yield using Illumina Protein Prep, showcasing its effectiveness in improving diagnostic capabilities [9] Stock Performance - Over the past six months, ILMN shares have risen by 14.2%, contrasting with a 1.7% decline in the industry [12]
舶望制药与诺华深化合作;国内首款全人群四价流感亚单位疫苗获批
Group 1: Industry Developments - Hainan Province is focusing on accelerating the development of the biopharmaceutical industry through enhanced government efficiency and strategic initiatives [1] - Jiangsu Zhonghui Yuantong Biotech's quadrivalent influenza subunit vaccine has received approval from NMPA, expanding its target population to include infants and the elderly [2] - Eisai and Biogen have submitted a rolling supplemental biologics license application for lecanemab to the FDA, aimed at early Alzheimer's disease patients [3] Group 2: Clinical Trials and Approvals - Lepu Medical's MWN105 injection has entered Phase II clinical trials, marking a significant step in its development [4] - Heng Rui Medicine has received approval for clinical trials of HRS-4729 injection, a novel peptide drug targeting multiple receptors [5] Group 3: Investment Activities - Sichuan Portong Medical plans to invest 150 million yuan in the Chengdu Rongchuang Fund, focusing on high-end medical devices and AI healthcare [7] - Shenzhen Mindray Technology has increased its stake in Huatai Medical to 25% through a block trade [8] - Best Idea International Limited has reduced its stake in Mengke Pharmaceutical to 8.91% due to financial needs [9] Group 4: Strategic Collaborations - Bewang Pharmaceutical and Novartis have deepened their collaboration to develop multiple cardiovascular products, including exclusive rights for certain drug candidates [10] Group 5: Product Launches - Illumina has launched Illumina Protein Prep, a product designed to enhance protein analysis in large-scale genomic studies [11] Group 6: Regulatory Actions - Sainuo Medical has received administrative regulatory measures from Tianjin Securities Regulatory Bureau due to inaccurate disclosures [12][13] Group 7: Mergers and Acquisitions - Aopu Mai is facing dissent regarding its 1.4 billion yuan acquisition plan for Chengli Bio, with concerns raised about its alignment with the company's strategic goals [14][15]
被禁售,Illumina大中华区Q2财报反超预期
仪器信息网· 2025-08-20 03:55
Core Viewpoint - Illumina reported a second-quarter revenue of $1.06 billion, a year-on-year decline of 3%, while adjusting its full-year revenue forecast to $4.23 billion to $4.31 billion, indicating a strategic shift towards multi-omics [2][4][6]. Financial Performance - The second-quarter revenue was $1.06 billion, down 2.8% year-on-year but up 1.7% quarter-on-quarter [4]. - Gross margin was 65.6%, down from 68.0% in the same period last year [4]. - Operating cash flow was $234 million, and free cash flow was $204 million [4]. - The company repurchased 4.5 million shares at an average price of approximately $85, with about $800 million remaining in the authorization [4]. Regional Revenue Breakdown - Revenue from Greater China was $63 million, a year-on-year decline of 16% [4]. - Instrument sales in Greater China fell by 40%, while reagent services decreased by 5% [4]. - European revenue was $310 million, a year-on-year increase of 7.3% [4]. - Americas revenue was $586 million, down 5.5% year-on-year [4]. - AMEA revenue was $100 million, down 7.4% year-on-year [4]. Product Sales and Strategic Initiatives - Sequencing instrument sales were approximately $96 million, with NovaSeq X shipments declining to around 50 units [5]. - Sequencing consumables revenue was $740 million, flat year-on-year but up 6% quarter-on-quarter [5]. - Since the new strategy was announced in August 2025, Illumina has been transitioning from single sequencing to integrated solutions in multi-omics, clinical, and data/software [5]. - The acquisition of SomaLogic was announced in June to expand into the proteomics field, further binding customers around sequencing as a core [5]. Updated Financial Guidance - The company raised its full-year revenue guidance from $4.18 billion to $4.26 billion to a new range of $4.23 billion to $4.31 billion [6].
KMDA vs. ILMN: Which Stock Is the Better Value Option?
ZACKS· 2025-08-14 16:40
Core Viewpoint - Kamada (KMDA) is currently positioned as a more attractive investment option compared to Illumina (ILMN) based on valuation metrics and earnings outlook [1][3][6] Valuation Metrics - KMDA has a forward P/E ratio of 21.09, while ILMN's forward P/E is 22.89 [5] - KMDA's PEG ratio stands at 0.84, indicating better value relative to its expected earnings growth, compared to ILMN's PEG ratio of 2.32 [5] - KMDA's P/B ratio is 1.68, significantly lower than ILMN's P/B ratio of 6.88, suggesting KMDA is undervalued relative to its book value [6] Earnings Outlook - KMDA has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while ILMN holds a Zacks Rank of 3 (Hold) [3][6] - The positive earnings estimate revisions for KMDA suggest a stronger improvement in earnings outlook compared to ILMN [3][6] Value Grades - KMDA has received a Value grade of A, while ILMN has a Value grade of C, further supporting the conclusion that KMDA is the superior value option [6]
跨国医疗器械企业布局“中国造”
Xin Hua Wang· 2025-08-12 05:48
Group 1 - Major multinational medical device companies are increasingly investing in local production in China, indicating a deepening localization strategy [1] - Illumina, a global leader in gene sequencing, has completed the delivery of its first series of products from its manufacturing base in China, which was established last year [1] - Siemens Healthineers has invested over 1 billion yuan in its Shenzhen production base, with 75% of products sold in China being locally produced in the second quarter of fiscal year 2023 [1] Group 2 - The Chinese medical device industry is experiencing rapid growth, with revenue reaching 1.3 trillion yuan in 2022, making it the second-largest market globally, and an average annual growth rate of 10.54% over the past five years [1] - It is projected that by 2030, China will become the largest medical device market in the world [1] - The competitive landscape is intensifying as both domestic and international companies improve product quality, prompting a focus on localization and supply chain resilience [1] Group 3 - The production capabilities in the Chinese market have significantly improved, facilitating multinational companies in establishing and strengthening local production [2] - Varian Medical established its R&D and production base in Beijing in 2007, initially producing only components due to a lack of local supply chain capabilities [2] - Siemens Healthineers emphasizes the need for skilled and well-educated talent in China, particularly in Shenzhen, which has influenced their decision to invest in new R&D and manufacturing facilities there [2]
Science:使用AI模型预测哪些启动子突变会改变基因表达
生物世界· 2025-08-11 04:02
Core Viewpoint - The article discusses the development of PromoterAI, an AI model by Illumina researchers, which accurately predicts expression-altering mutations in non-coding promoter regions, highlighting its significance in understanding genetic mutations and their impact on human health and rare diseases [3][4][6]. Group 1: PromoterAI Development and Functionality - PromoterAI is a deep learning model designed to predict the effects of promoter mutations on gene expression by evaluating genomic sequences in promoter regions [6]. - The model was trained at single nucleotide resolution to predict histone modifications, DNA accessibility, transcription factor binding, and gene expression around transcription start sites [6][9]. - The research team constructed a training dataset containing thousands of rare promoter mutations associated with abnormal gene expression across various tissues, controlling for confounding variables [6][9]. Group 2: Research Findings and Implications - The study found that predicted expression-altering promoter mutations were significantly enriched in clinically relevant genes of rare disease patients, contributing to 6% of the genetic burden associated with rare diseases [4][9]. - Analysis of population allele frequency spectra showed a significant depletion of predicted harmful mutations, indicating natural selection's role in removing deleterious mutations [7]. - PromoterAI's predictions were strongly correlated with protein abundance and quantitative trait measurements, enhancing the understanding of genetic contributions to rare diseases [7][9]. Group 3: Clinical Applications and Future Directions - The model was applied to undiagnosed rare disease patients in the Genomics England cohort, revealing a specific enrichment of predicted mutations in the promoter regions of Mendelian disease genes [7][9]. - PromoterAI fills a critical gap in genomic interpretation by accurately detecting promoter mutations that affect gene expression, which is often overlooked in current clinical genomic analyses focused on coding region mutations [9].
Illumina (ILMN) Reliance on International Sales: What Investors Need to Know
ZACKS· 2025-08-05 14:16
Core Insights - The performance of Illumina's international operations is crucial for understanding its financial strength and growth potential [1][2] - The company's reliance on international markets is a key factor in determining its financial success and growth trajectory [2][3] International Revenue Analysis - For the quarter ending June 2025, Illumina's total revenue was $1.06 billion, a decline of 4.8% year over year [4] - Europe contributed $310 million, accounting for 29.3% of total revenue, exceeding analyst expectations of $293.21 million [5] - Greater China accounted for 6% of total revenue, translating to $63 million, slightly above the expected $62.52 million [6] Revenue Projections - Analysts project Illumina's revenues for the ongoing fiscal quarter to be $1.06 billion, a decline of 1.8% from the previous year, with expected contributions from Europe at 27.9% ($296.38 million) and Greater China at 4% ($42.13 million) [7] - For the full year, total revenue is projected to be $4.27 billion, a decrease of 2.4% from last year, with Europe expected to contribute $1.19 billion (27.8%) and Greater China $219.82 million (5.2%) [8] Conclusion on International Revenue Trends - Illumina's reliance on international markets presents both opportunities and challenges, making it essential to track international revenue trends for future projections [9][10]
Illumina: The Stock Is Still Undervalued
Seeking Alpha· 2025-08-04 08:23
Group 1 - The article discusses the investment focus on growth companies, particularly in mid-cap segments, with an emphasis on sectors such as biotechnology, computer chips, cloud technology, energy, and commodities [1] - It highlights the importance of analyzing regulatory risks in both China and the US, which could impact companies like Illumina [1] - A systematic balance sheet analysis will be conducted to assess the financial health of growing businesses, as many may struggle with funding [1] Group 2 - The investment strategy prioritizes long-term capital appreciation over short-term speculation, indicating a preference for sustainable growth [1] - The article mentions the use of stress tests to evaluate the robustness of investment theses and the safety of business models [1] - The author expresses a commitment to providing extensive coverage on relevant themes and welcomes feedback to improve the analysis [1]
Illumina (ILMN) Q2 EPS Jumps 9%
The Motley Fool· 2025-08-01 23:23
Core Insights - Illumina reported strong second quarter results for fiscal 2025, exceeding analyst expectations for both non-GAAP EPS and GAAP revenue, with non-GAAP EPS at $1.19 and GAAP revenue at $1.06 billion, despite a 3% decline from the previous year [1][5][11] - The company raised its full-year guidance, expecting non-GAAP EPS in the range of $4.45–$4.55 and non-GAAP operating margin at approximately 22%–22.5%, driven by better performance in clinical markets and strong adoption of NovaSeq X consumables [1][11][12] Financial Performance - Non-GAAP EPS reached $1.19, surpassing the consensus estimate of $1.01, marking a year-over-year increase of 9.2% [2] - GAAP revenue was $1.06 billion, slightly above the estimate of $1.05 billion, but down 3% from Q2 2024 [2][5] - Non-GAAP operating margin improved to 23.8%, up 1.6 percentage points year-over-year, reflecting effective cost control measures [2][6] - Net income (non-GAAP) was $187 million, a 7.5% increase from $174 million in the previous year [2] - Free cash flow was $204 million, down from $213 million year-over-year, indicating strong cash conversion despite a slight decline [2][10] Business Overview - Illumina specializes in DNA sequencing equipment, software, and supplies, serving clinical laboratories, research centers, and healthcare providers [3] - The company’s product portfolio includes high-throughput sequencers like NovaSeq X and lower-throughput options such as MiSeq i100, along with consumables and software solutions [3] Innovation and Market Strategy - Continuous investment in R&D is crucial for Illumina to develop advanced, cost-effective sequencing technologies [4] - The company aims to expand its presence in clinical markets while facing challenges in research funding [4] - Key success factors include successful commercialization of new products, regulatory compliance, international expansion (excluding China), and partnerships in emerging fields like multi-omics and AI [4] Operational Developments - The clinical market experienced mid-single-digit growth, which helped offset declines in research revenues, expected to drop by approximately 15% for the remainder of the year [7][12] - The company launched new products and upgrades, including TruSight Oncology 500 v2 and PromoterAI software, enhancing its product offerings [8][9] - Service and other revenue decreased by 20.5% due to the absence of one-off partnership revenue from the previous year [9] Future Outlook - Management anticipates a smaller decline in total company constant currency revenue, now expecting a range of 0.5% to 2.5% [11] - The improved outlook is primarily based on cost control and margin improvement rather than organic revenue growth, with continued challenges in the research segment and low revenue contribution from China [12]
Illumina(ILMN) - 2026 Q2 - Quarterly Report
2025-08-01 21:24
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Illumina's unaudited interim financial statements for the quarter ended June 29, 2025, detailing financial position, performance, and cash flows, along with explanatory notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 29, 2025, total assets, liabilities, and stockholders' equity all decreased compared to year-end 2024, primarily influenced by changes in cash and treasury stock purchases Condensed Consolidated Balance Sheets (In millions) | | June 29, 2025 (Unaudited) | December 29, 2024 | | :--- | :--- | :--- | | **Total current assets** | $2,641 | $2,746 | | **Total assets** | $6,087 | $6,303 | | **Total current liabilities** | $1,461 | $1,547 | | **Total liabilities** | $3,829 | $3,930 | | **Total stockholders' equity** | $2,258 | $2,373 | | **Total liabilities and stockholders' equity** | $6,087 | $6,303 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, total revenue decreased, but the company achieved a significant net income turnaround from a prior-year loss, which was impacted by a goodwill impairment charge Q2 and Six Months Ended Financial Performance (In millions, except per share amounts) | | Three Months Ended June 29, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 29, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total revenue** | $1,059 | $1,112 | $2,100 | $2,188 | | **Gross profit** | $695 | $721 | $1,378 | $1,388 | | **Income (loss) from operations** | $214 | $(1,637) | $378 | $(1,749) | | **Net income (loss)** | $235 | $(1,988) | $366 | $(2,114) | | **Diluted EPS** | $1.49 | $(12.48) | $2.31 | $(13.28) | [Condensed Consolidated Statements of Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%20%28Loss%29) Total comprehensive income for Q2 2025 was $206 million, a significant improvement from a prior-year loss, primarily driven by net income offset by unrealized losses on cash flow hedges Comprehensive Income (Loss) Summary (In millions) | | Three Months Ended June 29, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 29, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net income (loss)** | $235 | $(1,988) | $366 | $(2,114) | | **Unrealized (loss) gain on cash flow hedges, net of deferred tax** | $(29) | $2 | $(43) | $15 | | **Total comprehensive income (loss)** | $206 | $(1,986) | $323 | $(2,099) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased as of June 29, 2025, primarily due to share repurchases that more than offset net income for the first six months - Key changes in stockholders' equity for the six months ended June 29, 2025 include a net income of **$366 million**, offset by share repurchases and an unrealized loss on cash flow hedges[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 29, 2025, operating cash flow significantly increased, while cash used in financing activities, primarily share repurchases, led to a net decrease in cash and cash equivalents Cash Flow Summary (Six Months Ended, In millions) | | June 29, 2025 | June 30, 2024 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $474 | $157 | | **Net cash used in investing activities** | $(112) | $(89) | | **Net cash used in financing activities** | $(566) | $(191) | | **Net decrease in cash and cash equivalents** | $(193) | $(128) | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the company's accounting policies and financial results, covering significant events like the GRAIL spin-off, pending acquisitions, and segment performance [Management's Discussion & Analysis](index=27&type=section&id=MANAGEMENT%27S%20DISCUSSION%20%26%20ANALYSIS) [Management's Overview and Outlook](index=27&type=section&id=Management%27s%20Overview%20and%20Outlook) Management discusses business trends, including macroeconomic challenges and the GRAIL spin-off, while focusing on returning to revenue growth in 2025 through cost reduction and strategic acquisitions - On June 22, 2025, Illumina agreed to acquire SomaLogic for **$350 million** in cash, plus potential royalties and up to **$75 million** in milestone payments, to expand into the proteomics market. The deal is expected to close in the first half of 2026[124](index=124&type=chunk) - The company is facing headwinds from macroeconomic factors, competitive challenges in China, and reduced NIH funding. In response, it implemented an incremental **$100 million** cost reduction program for 2025[126](index=126&type=chunk)[127](index=127&type=chunk) - For the first six months of 2025, revenue decreased **4%** to **$2.1 billion**, while income from operations was **$378 million**, a significant improvement from a loss of **$1.749 billion** in the same period of 2024, which included a **$1.886 billion** goodwill impairment for GRAIL[129](index=129&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of Illumina's financial performance, breaking down changes in revenue, gross margin, and operating expenses, attributing shifts to various business and accounting factors [Revenue](index=32&type=section&id=Revenue_MD%26A) Consolidated revenue decreased in Q2 and YTD 2025, primarily due to the GRAIL spin-off and a decline in Core Illumina instrument revenue driven by capital constraints Revenue by Segment (In millions) | | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Core Illumina Revenue** | $1,059 | $1,092 | (3)% | $2,100 | $2,148 | (2)% | | *Instruments* | $101 | $120 | (16)% | $213 | $234 | (9)% | | *Consumables* | $811 | $815 | —% | $1,580 | $1,584 | —% | | **GRAIL Revenue** | — | $29 | (100)% | — | $55 | (100)% | | **Total Consolidated Revenue** | $1,059 | $1,112 | (5)% | $2,100 | $2,188 | (4)% | [Gross Margin](index=32&type=section&id=Gross%20Margin_MD%26A) Consolidated gross margin increased due to the GRAIL spin-off, but Core Illumina's gross margin declined in Q2 2025 due to an intangible asset impairment, higher tariffs, and increased service costs - Core Illumina's gross margin declined in Q2 and YTD 2025 due to a **$23 million** intangible asset impairment, increased tariff-related costs, and higher field service expenses[135](index=135&type=chunk) [Operating Expense](index=33&type=section&id=Operating%20Expense_MD%26A) Total operating expenses significantly decreased in Q2 2025 primarily due to the absence of a large prior-year goodwill impairment charge related to GRAIL, despite an increase in Core Illumina's SG&A expense - The significant decrease in total operating expense YoY is due to the absence of the **$1.886 billion** goodwill and intangible impairment charge related to GRAIL that was recorded in Q2 2024[136](index=136&type=chunk)[139](index=139&type=chunk) - Core Illumina's SG&A expense increased in Q2 2025 primarily because of a smaller gain recognized on contingent consideration liabilities (**$21 million** in Q2 2025 vs. **$271 million** in Q2 2024)[137](index=137&type=chunk) [Other Income (Expense)](index=34&type=section&id=Other%20Income%20%28Expense%29_MD%26A) Total other income in Q2 2025 showed a sharp reversal from a prior-year expense, primarily driven by net gains on strategic investments compared to significant losses in Q2 2024 - The fluctuation in other income was mainly due to recognizing a **$101 million** gain on strategic investments in Q2 2025, versus a **$335 million** loss in Q2 2024. The prior year loss was primarily related to the retained investment in GRAIL[140](index=140&type=chunk) [Provision for Income Taxes](index=34&type=section&id=Provision%20for%20Income%20Taxes_MD%26A) The effective tax rate for Q2 and YTD 2025 was positive, a significant change from 2024, and was above the U.S. federal statutory rate primarily due to the tax impact of capitalizing R&D expenses - The effective tax rate for Q2 2025 was **23.4%**, higher than the U.S. statutory rate of **21%**, mainly due to the income tax expense impact of capitalizing R&D expenses for tax purposes[141](index=141&type=chunk) - The company anticipates its effective tax rate will decrease starting in Q3 2025 due to recent U.S. tax legislation that no longer requires the capitalization of U.S.-based R&D expenses[143](index=143&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 29, 2025, cash and equivalents decreased primarily due to share repurchases, with key capital commitments including the SomaLogic acquisition and ongoing share repurchase programs Cash Flow Summary (YTD 2025, In millions) | | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $474 | $157 | | **Net cash used in investing activities** | $(112) | $(89) | | **Net cash used in financing activities** | $(566) | $(191) | | **Net decrease in cash and cash equivalents** | $(193) | $(128) | - The company has a commitment to acquire SomaLogic for **$350 million** in cash, plus potential milestones. A termination fee of **$14.5 million** is payable by Illumina under certain circumstances[147](index=147&type=chunk) - A new share repurchase program of **$1.5 billion** was authorized in August 2024. As of June 29, 2025, **$804 million** remained available under this authorization[149](index=149&type=chunk) [Critical Accounting Policies and Estimates](index=36&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There were no material changes to the company's critical accounting policies and estimates during the first half of 2025, despite ongoing macroeconomic and regulatory uncertainties - There were no material changes to the company's critical accounting policies and estimates during YTD 2025[157](index=157&type=chunk) [Recent Accounting Pronouncements](index=36&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to Note 1 of the financial statements for a summary of recent accounting pronouncements applicable to the company - For a summary of recent accounting pronouncements, see Note 1 in the Condensed Consolidated Financial Statements section[158](index=158&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no substantial changes to its market risks during the first half of 2025 compared to the disclosures in its 2024 Annual Report on Form 10-K - There were no substantial changes to market risks in YTD 2025 compared to the disclosures in the 2024 Form 10-K[159](index=159&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Controls and Procedures](index=36&type=section&id=Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the quarter-end, with no material changes in internal control over financial reporting during Q2 2025 - The CEO and CFO concluded that the company's disclosure controls and procedures are effective to provide reasonable assurance[162](index=162&type=chunk) - No changes in internal control over financial reporting occurred in Q2 2025 that materially affected or are reasonably likely to materially affect internal controls[161](index=161&type=chunk) [Legal Proceedings](index=37&type=section&id=Legal%20Proceedings) This section refers to Note 8 for detailed legal proceedings, including ongoing shareholder lawsuits related to the GRAIL acquisition and a recent settlement with the Department of Justice - The company is involved in multiple shareholder derivative and class action lawsuits related to the GRAIL acquisition, which it intends to vigorously defend[93](index=93&type=chunk)[104](index=104&type=chunk)[106](index=106&type=chunk) - On July 22, 2025, the company settled a False Claims Act investigation with the Department of Justice for a one-time payment of **$9.8 million** plus interest, resolving allegations of misrepresenting cybersecurity compliance[107](index=107&type=chunk) [Risk Factors](index=37&type=section&id=Risk%20Factors) The company directs readers to the Risk Factors sections in its Annual Report on Form 10-K for the fiscal year ended December 29, 2024, and its Q1 2025 Form 10-Q for a description of business risks - The company's business is subject to various risks as described in its 2024 Form 10-K and Q1 2025 Form 10-Q[164](index=164&type=chunk) [Share Repurchases and Sales](index=37&type=section&id=Share%20Repurchases%20and%20Sales) The company continued its share repurchase program in Q2 2025, repurchasing 4.489 million shares for approximately $380 million, with substantial authorization remaining Share Repurchases in Q2 2025 (in thousands, except price) | Period | Total Shares Purchased | Average Price Paid per Share | Approx. Dollar Value Remaining | | :--- | :--- | :--- | :--- | | March 31 - April 27, 2025 | — | $— | $1,184,405 | | April 28 - May 25, 2025 | 1,384 | $81.31 | $1,071,906 | | May 26 - June 29, 2025 | 3,105 | $86.15 | $804,406 | | **Total** | **4,489** | **$84.66** | **$804,406** | [Adoptions, Modifications or Terminations of Trading Plans](index=37&type=section&id=Adoptions%2C%20Modifications%20or%20Terminations%20of%20Trading%20Plans) During the second quarter of 2025, none of the company's directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - No director or officer adopted, modified, or terminated a trading plan during Q2 2025[167](index=167&type=chunk) [Exhibits](index=38&type=section&id=Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Stock Purchase Agreement with Standard BioTools, certifications by the CEO and CFO, and XBRL data files