Merit Medical(MMSI)
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First Patient Enrolled in Merit Medical's WRAPSODY (WRAP) North America Registry
GlobeNewswire News Room· 2025-08-18 13:25
Core Insights - Merit Medical Systems, Inc. has successfully enrolled the first patient in the WRAP North America registry, aimed at evaluating the WRAPSODY Cell-Impermeable Endoprosthesis (CIE) for patients on hemodialysis [1][5][8] Group 1: WRAP North America Registry - The WRAP North America registry is designed to enroll up to 250 patients in the US and Canada who are on hemodialysis and experience vascular access obstructions [2][4] - The registry will evaluate clinical outcomes over three years for patients treated with the WRAPSODY CIE [2][4] - The first patient was enrolled by Dr. Omar Davis at Bluff City Vascular, marking a significant milestone for the company [2][5] Group 2: WRAPSODY CIE Device - The WRAPSODY CIE aims to restore vascular access for hemodialysis patients facing obstructions, with promising results demonstrated in the previous WAVE pivotal trial [3][4] - The WAVE trial compared the WRAPSODY CIE with percutaneous transluminal angioplasty (PTA) and historical outcomes of patients treated with previous-generation covered stents [3] - The device received premarket approval from the FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [7] Group 3: Clinical Evidence and Future Prospects - The WRAP North America registry is expected to contribute to a growing portfolio of clinical evidence supporting the WRAPSODY CIE [4] - A parallel WRAP Global registry is also being conducted to enroll up to 500 patients outside North America, with final enrollment expected by the end of 2025 [5] - The company emphasizes the importance of real-world effectiveness data to address critical questions regarding the device's broader impact in clinical practice [4][5]
Merit Medical (MMSI) is a Top-Ranked Momentum Stock: Should You Buy?
ZACKS· 2025-08-14 14:51
Core Insights - Zacks Premium offers tools to enhance investor confidence and market engagement through daily updates, research reports, and stock screens [1][2] Zacks Style Scores - Zacks Style Scores are indicators that rate stocks based on value, growth, and momentum methodologies, helping investors identify stocks likely to outperform the market in the next 30 days [2][3] - Stocks are rated A, B, C, D, or F, with A being the highest score indicating a better chance of outperforming [3] Value Score - The Value Score focuses on identifying undervalued stocks using ratios like P/E, PEG, Price/Sales, and Price/Cash Flow [3] Growth Score - The Growth Score assesses a company's financial health and future outlook by analyzing projected and historical earnings, sales, and cash flow [4] Momentum Score - The Momentum Score identifies stocks with upward or downward trends based on price changes and earnings estimates, aiding in timing purchases of high-momentum stocks [5] VGM Score - The VGM Score combines Value, Growth, and Momentum Scores, serving as a comprehensive indicator alongside the Zacks Rank [6] Zacks Rank - The Zacks Rank utilizes earnings estimate revisions to help investors build successful portfolios, with 1 (Strong Buy) stocks achieving an average annual return of +23.75% since 1988, significantly outperforming the S&P 500 [7][8] - There are over 800 top-rated stocks available, making selection challenging for investors [8] Stock Selection Strategy - Investors should prioritize stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B to maximize potential success [9][10] Company Spotlight: Merit Medical Systems, Inc. (MMSI) - Merit Medical, based in South Jordan, UT, specializes in peripheral and cardiac intervention products [11] - MMSI holds a Zacks Rank of 3 (Hold) with a VGM Score of A and a Momentum Style Score of B, having increased by 2.6% over the past four weeks [11] - Six analysts have raised their earnings estimates for fiscal 2025, with the Zacks Consensus Estimate increasing by $0.25 to $3.60 per share, and an average earnings surprise of +12.9% [12]
Merit Medical Launches the Prelude Wave Hydrophilic Sheath Introducer with SnapFix Technology
Globenewswire· 2025-08-07 13:25
Core Insights - Merit Medical Systems, Inc. has launched the Prelude Wave™ Hydrophilic Sheath Introducer with SnapFix™ Securement Technology, aimed at enhancing radial access procedures and potentially reducing arterial spasm and occlusion [1][2] Product Features - The Prelude Wave is part of Merit's Access portfolio, featuring a low-profile, hydrophilic design that offers best-in-class insertion and sheath retention [2] - The sheath is designed to reduce risks associated with radial artery spasm, which occurs in up to 20% of patients, and occlusion, which affects approximately 4.6% of patients [3][4] - The Prelude Wave provides twice the lubricity, resistance to buckling and kinking, and requires 40% less insertion force compared to leading competitors [6] Clinical Impact - The introduction of SnapFix technology offers twice the adhesive strength, enhancing the performance and ease of use for physicians [6] - The securement devices used for stabilizing hydrophilic sheaths have been linked to procedural inefficiencies in 30% of cases, indicating a significant need for improved solutions [5] Strategic Positioning - Merit Medical aims to support a radial-first approach by complementing existing products and addressing clinical challenges, as demonstrated by its acquisition of StatSeal®, a hemostatic sealant for radial procedures [8] - The company emphasizes its commitment to innovation in its Access portfolio, providing healthcare partners with data-driven treatment solutions [9]
Merit Medical (MMSI) Q2 Revenue Up 13%
The Motley Fool· 2025-08-01 09:36
Core Insights - Merit Medical Systems reported strong Q2 2025 results with GAAP revenue of $382.5 million, a 13.2% increase year-over-year, surpassing analyst expectations of $374.2 million [1][2] - Non-GAAP EPS reached $1.01, exceeding the estimate of $0.85, while GAAP EPS declined 11.6% to $0.54 [1][2] - The company experienced broad-based growth, particularly in the Cardiac Intervention and Endoscopy device lines, and raised its full-year revenue and non-GAAP earnings outlook [1][10] Financial Performance - Q2 2025 Non-GAAP EPS was $1.01, up 9.8% from $0.92 in Q2 2024 [2] - GAAP revenue was $382.5 million, compared to $338.0 million in Q2 2024, reflecting a 13.2% year-over-year increase [2] - Non-GAAP gross margin improved to 53.2%, and operating margin rose to 21.2% [2][7] Product Segment Performance - Cardiovascular devices generated $364.0 million, an 11.0% increase, with Cardiac Intervention products up 23.5% year-over-year [5] - The Endoscopy segment saw an 81.0% rise to $18.4 million, driven by acquisitions [6] Strategic Focus and Investments - The company emphasizes continuous product development, international market expansion, and regulatory compliance [3][4] - R&D investment for the quarter was $24.4 million, indicating a commitment to innovation [7] Acquisition and Compliance Costs - The quarter included significant acquisition and compliance expenses, with $21.5 million in amortization of acquired intangible assets and $1.6 million in MDR compliance costs [8] - Integration costs from recent acquisitions were recognized in non-GAAP adjustments, reflecting the company's growth strategy [8] Cash Flow and Capital Expenditures - Merit generated $89.1 million in free cash flow (non-GAAP) in the first half of 2025, an 8.1% increase year-over-year [9] - Capital expenditures rose to $34.8 million as the company invested in new products and expanded capacity [9] Future Outlook - Management raised FY2025 revenue guidance to $1.495–$1.507 billion and non-GAAP EPS to $3.52–$3.72 [10] - Cardiovascular segment revenue is projected to be $1.423–$1.434 billion, while the Endoscopy segment is expected to reach $72–$73 million [10]
Merit Medical Q2 Earnings Beat Estimates, Gross Margin Expands
ZACKS· 2025-07-31 18:20
Core Insights - Merit Medical Systems, Inc. (MMSI) reported second-quarter 2025 adjusted earnings per share (EPS) of $1.01, reflecting a 9.8% increase year over year and surpassing the Zacks Consensus Estimate by 17.4% [1][9] - The company's total revenues reached $382.5 million, marking a 13.2% year-over-year increase [2][9] Revenue Details - Revenues increased by 12.5% year over year at constant exchange rates (CER), with organic revenues rising 6.7% [2] - U.S. sales were $227.1 million, up 16.7% year over year, while international sales reached $155.4 million, up 8.4% [3][4] Geographic Results - Asia-Pacific (APAC) revenues were $66.6 million, down 0.4% year over year, while revenues from Europe, the Middle East, and Africa were $72.6 million, up 16.5% [4] - Revenues from the Rest of World region were $16.2 million, up 13.9% year over year [5] Segmental Details - The Cardiovascular segment reported revenues of $364 million, up 11% year over year [6] - Within the Cardiovascular unit, Cardiac Intervention (CI) revenues rose 23.5% to $115.3 million, while Peripheral Intervention (PI) revenues increased 6.3% to $142.8 million [7][8] Margin Analysis - Gross profit increased 14.5% year over year to $184.5 million, with a gross margin of 48.2% [11] - Adjusted operating profit totaled $47 million, reflecting a 1.7% increase from the prior year, although the adjusted operating margin contracted to 12.3% [12] Financial Position - At the end of the second quarter, cash and cash equivalents were $341.8 million, down from $395.5 million at the end of the first quarter [13] - Total long-term debt was $731.8 million, slightly up from $730.7 million in the previous quarter [13] Guidance - The company revised its 2025 revenue outlook to between $1.495 billion and $1.507 billion, reflecting a year-over-year increase of 10.2-11.1% [14] - Adjusted EPS for 2025 is now projected to be in the range of $3.52-$3.72, an increase from the previous outlook [17] Strategic Developments - In May, the company acquired Biolife Delaware, L.L.C., enhancing its portfolio [20] - The approval of the Wrapsody Cell-Impermeable Endoprosthesis by Health Canada is expected to positively impact the company [20]
Merit Medical (MMSI) Reports Q2 Earnings: What Key Metrics Have to Say
ZACKS· 2025-07-30 23:31
Core Insights - Merit Medical reported revenue of $382.46 million for the quarter ended June 2025, reflecting a 13.2% increase year-over-year, with EPS at $1.01 compared to $0.92 in the previous year [1] - The reported revenue met the Zacks Consensus Estimate, while the EPS exceeded the consensus estimate by 17.44% [1] Financial Performance Metrics - U.S. sales reached $227.08 million, surpassing the estimated $220.3 million, marking a 16.7% increase from the same quarter last year [4] - International sales amounted to $155.38 million, exceeding the estimated $151.04 million, representing an 8.4% year-over-year growth [4] - Revenue from Cardiovascular-Peripheral Intervention was $142.85 million, slightly below the estimated $144.62 million, with a year-over-year increase of 2.6% [4] - Cardiovascular-Cardiac Intervention revenue was $115.25 million, exceeding the estimated $104.93 million, showing a significant 22.8% increase year-over-year [4] - Endoscopy revenue reached $18.44 million, slightly below the estimated $18.66 million, but reflecting an impressive 81% increase from the previous year [4] - Cardiovascular-OEM revenue was $52.29 million, close to the estimated $52.65 million, with an 18.1% year-over-year increase [4] - Total Cardiovascular revenue was $364.03 million, surpassing the estimated $353.56 million, indicating an 11.1% increase year-over-year [4] - Revenue from Cardiovascular-Custom Procedural Solutions was $53.63 million, exceeding the estimated $51.05 million, with a year-over-year growth of 6.4% [4] Stock Performance - Merit Medical's shares have declined by 11.8% over the past month, contrasting with a 3.4% increase in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]
Merit Medical(MMSI) - 2025 Q2 - Earnings Call Transcript
2025-07-30 22:02
Financial Data and Key Metrics Changes - The company reported total revenue of $382.5 million, up 13% year over year on a GAAP basis and up 12.5% year over year on a constant currency basis, exceeding growth expectations [8][9] - Non-GAAP operating margin increased nearly 109 basis points year over year to 21.2%, representing the highest performance in the company's history as a public company [9] - Non-GAAP EPS grew by 10%, exceeding expectations, and free cash flow increased by 20% year over year to $70 million [9][32] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 10% and endoscopy segment sales increased by 81% [24] - Cardiac intervention product sales rose by 23%, with organic growth of approximately 10% [25] - Peripheral intervention products and custom procedure solutions saw sales increases of 6% and above expectations, respectively [25] Market Data and Key Metrics Changes - U.S. sales increased by 17% on a constant currency basis and 10% on an organic constant currency basis [28] - International sales grew by 7% year over year, with a 2% increase on an organic constant currency basis [28] - Sales in China decreased by 6%, attributed to the broader macro environment [29][80] Company Strategy and Development Direction - The company announced the acquisition of BioLife Delaware LLC for $120 million, aimed at enhancing its product offerings in hemostatic solutions [10][11] - A comprehensive marketing plan for the Rhapsody CIE was launched, focusing on expanding physician relationships and securing reimbursement coverage [15][16] - The company is targeting a premium pricing strategy for the Rhapsody CIE, emphasizing its unique treatment options and clinical benefits [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong execution and revenue growth despite a challenging global macro environment [10] - The company acknowledged a two-quarter delay in securing add-on reimbursement for the Rhapsody CIE in the outpatient setting but maintained long-term growth expectations [22][37] - Management emphasized the importance of their reimbursement strategy and ongoing engagement with CMS to secure necessary approvals [21][56] Other Important Information - The company updated its 2025 financial guidance, expecting GAAP net revenue growth of 10% to 11% and non-GAAP diluted EPS in the range of $3.52 to $3.72 [34][39] - The anticipated impact of tariffs on cost of goods was revised down to approximately $7 million, reflecting better-than-expected performance [38] Q&A Session Summary Question: Clarification on Rhapsody reimbursement process - Management clarified that they applied for a new technology APC assignment but did not receive it, and they plan to submit for TPT by September 1 [46][48] Question: Confidence in securing TPT - Management expressed high confidence in meeting TPT guidelines and emphasized the strength of their product data [55][60] Question: Sales performance in cardiac intervention - Management attributed the sales uplift to internal product development and the strategic acquisition of Cook Medical [100][106]
Merit Medical(MMSI) - 2025 Q2 - Earnings Call Transcript
2025-07-30 22:00
Financial Data and Key Metrics Changes - The company reported total revenue of $382.5 million, up 13% year over year on a GAAP basis and up 12.5% year over year on a constant currency basis [7][9] - Non-GAAP operating margin increased nearly 109 basis points year over year to 21.2%, representing the highest performance in the company's history as a public company [9] - Non-GAAP EPS grew by 10%, exceeding expectations, and free cash flow increased by 20% year over year to $70 million [9][34] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 10% and endoscopy segment sales increased by 81% [26] - Cardiac intervention product sales rose by 23%, with organic growth of approximately 10% [27] - Peripheral intervention products and custom procedure solutions saw sales increases of 6% and 4%, respectively [28] Market Data and Key Metrics Changes - U.S. sales increased by 17% on a constant currency basis, while international sales grew by 7% year over year [30] - Sales in China decreased by 6%, attributed to the broader macro environment [31][75] - The company expects low double-digit growth in EMEA and mid-teens growth in the Rest of the World region, with approximately 2% growth in the APAC region [37] Company Strategy and Development Direction - The company announced the acquisition of BioLife Delaware LLC for $120 million, aimed at enhancing its product offerings in hemostatic solutions [10][11] - A comprehensive marketing plan for the Rhapsody CIE was launched, focusing on raising awareness and expanding physician relationships [14] - The pricing strategy for Rhapsody CIE is based on a premium price relative to competitors, supported by clinical evidence demonstrating its efficacy [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong execution and revenue growth despite a dynamic global macro environment [10] - The company acknowledged a two-quarter delay in securing add-on reimbursement for the outpatient setting but maintained long-term growth expectations for Rhapsody CIE [24][39] - Management emphasized the importance of their reimbursement strategy and ongoing engagement with CMS to secure necessary approvals [23][49] Other Important Information - The company updated its 2025 financial guidance, expecting GAAP net revenue growth of 10% to 11% and non-GAAP diluted EPS in the range of $3.52 to $3.72 [36][40] - The anticipated impact of tariffs on the cost of goods is expected to be significantly lower than previously forecasted [41][42] Q&A Session Summary Question: Clarification on Rhapsody reimbursement process - Management clarified that they applied for a new technology APC assignment but did not receive it, and they plan to submit for TPT by September 1 [49][50] Question: Confidence in securing TPT - Management expressed high confidence in meeting TPT guidelines and emphasized the strength of their product and data [62] Question: Sales performance in cardiac intervention - Management attributed the growth to internal product development and the strategic acquisition of Cook Medical, expecting continued strong performance [94][96]
Merit Medical(MMSI) - 2025 Q2 - Earnings Call Presentation
2025-07-30 21:00
Q2 2025 Financial Performance (GAAP) - Revenue increased by 132% to $3825 million in Q2 2025 compared to $3380 million in Q2 2024[8] - Net income decreased by 88% to $326 million in Q2 2025 from $357 million in Q2 2024[8] - Earnings per share decreased by 116% to $054 in Q2 2025 compared to $061 in Q2 2024[8] Q2 2025 Financial Performance (Non-GAAP) - Revenue increased by 67% to $3606 million in Q2 2025 compared to $3380 million in Q2 2024[9] - Net income increased by 133% to $610 million in Q2 2025 from $538 million in Q2 2024[9] - Earnings per share increased by 98% to $101 in Q2 2025 compared to $092 in Q2 2024[9] Revenue Breakdown (Q2 2025) - US revenue increased by 167% to $227082 thousand in Q2 2025[11] - APAC revenue decreased by 04% to $66566 thousand in Q2 2025[11] - EMEA revenue increased by 165% to $72615 thousand in Q2 2025[11] Fiscal Year 2025 Financial Guidance - Sales Net are projected to be between $1495 billion and $1507 billion, representing a 10%-11% year-over-year change[14] - Non-GAAP earnings per share are expected to be between $352 and $372, representing a 2%-8% year-over-year change[14]
Merit Medical(MMSI) - 2025 Q2 - Quarterly Report
2025-07-30 20:19
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited H1 2025 financials show asset growth, increased sales, and positive operating cash flow, with significant cash used for acquisitions [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, reflects growth in total assets, liabilities, and stockholders' equity, primarily due to acquisitions Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$2,586,045** | **$2,418,603** | | Total Current Assets | $923,072 | $923,774 | | Goodwill | $504,555 | $463,511 | | **Total Liabilities** | **$1,097,997** | **$1,039,244** | | Long-term debt | $731,795 | $729,551 | | **Total Stockholders' Equity** | **$1,488,048** | **$1,379,359** | [Consolidated Statements of Income](index=6&type=section&id=Consolidated%20Statements%20of%20Income) Net sales increased for both Q2 and H1 2025, while net income and diluted EPS experienced slight declines Six Months Ended June 30, (in thousands, except per share data) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net sales | $737,813 | $661,511 | | Gross profit | $356,507 | $312,815 | | Income from operations | $87,913 | $81,868 | | Net income | $62,728 | $63,966 | | Diluted EPS | $1.03 | $1.09 | Three Months Ended June 30, (in thousands, except per share data) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net sales | $382,462 | $338,003 | | Gross profit | $184,487 | $161,100 | | Income from operations | $46,880 | $45,946 | | Net income | $32,581 | $35,726 | | Diluted EPS | $0.54 | $0.61 | [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow increased, but significant cash was used in investing activities, primarily for acquisitions, resulting in a net decrease in cash Cash Flow Summary for Six Months Ended June 30, (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash from operating activities | $123,879 | $104,722 | | Net cash used in investing activities | $(172,986) | $(38,538) | | Net cash from (used in) financing activities | $11,302 | $(14,866) | | **Net (decrease) increase in cash** | **$(34,852)** | **$49,568** | | Cash at end of period | $343,915 | $638,712 | - Cash paid for acquisitions, net of cash acquired, was **$122.6 million** in the first six months of 2025, compared to only **$4.9 million** in the same period of 2024[19](index=19&type=chunk) [Condensed Notes to Consolidated Financial Statements](index=12&type=section&id=Condensed%20Notes%20to%20Consolidated%20Financial%20Statements) Notes detail accounting policies, segment revenue growth driven by acquisitions, increased goodwill, a higher tax rate, and significant debt with available borrowing capacity - On May 20, 2025, Merit acquired Biolife for an upfront payment of **$120 million** plus **$6.3 million** in adjustments. The acquisition added **$92.7 million** in developed technology and **$38.3 million** in goodwill[30](index=30&type=chunk) Revenue by Segment - Six Months Ended June 30, (in thousands) | Segment | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Cardiovascular | $702,738 | $641,189 | +9.6% | | Endoscopy | $35,075 | $20,322 | +72.6% | | **Total** | **$737,813** | **$661,511** | **+11.5%** | - The company is cooperating with an SEC inquiry that began in January 2022 regarding its subsidiary's business activities in China. The outcome and potential loss cannot be reasonably estimated at this time[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses sales growth driven by segment and market demand, improved gross margin, increased operating expenses, a slight net income decline, and strong liquidity [Results of Operations](index=44&type=section&id=Results%20of%20Operations) H1 2025 sales growth was driven by acquisitions and segment performance, with improved gross margin, but increased operating expenses led to a net income decline Sales Growth by Segment - Six Months Ended June 30, 2025 vs 2024 | Segment | % Change | | :--- | :--- | | Cardiovascular | +9.6% | | Endoscopy | +72.6% | | **Total** | **+11.5%** | - The **17.2%** growth in Cardiac Intervention sales for H1 2025 was primarily driven by **$19.4 million** in sales from products acquired from Cook in November 2024[117](index=117&type=chunk) - The **72.6%** growth in Endoscopy sales for H1 2025 was favorably affected by **$14.7 million** in sales of the EsophyX® Z+ device acquired from EGS in July 2024[116](index=116&type=chunk) - SG&A expenses for H1 2025 increased by **16.7%** primarily due to higher labor-related costs from headcount additions, including those from the EGS, Cook, and Biolife acquisitions[124](index=124&type=chunk) [Liquidity and Capital Resources](index=50&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) The company maintains strong liquidity with substantial cash and available credit, despite significant cash usage for acquisitions and capital expenditures - The company holds **$343.9 million** in cash, cash equivalents, and restricted cash as of June 30, 2025, with **$69.7 million** held by foreign subsidiaries[134](index=134&type=chunk) - Capital expenditures are expected to be approximately **$90 million to $100 million** in 2025, partly for the construction of a new distribution facility in South Jordan, Utah[135](index=135&type=chunk) - As of June 30, 2025, the company had no outstanding borrowings under its revolving credit facility and had additional available borrowings of approximately **$697 million**[49](index=49&type=chunk)[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes were reported in market risk disclosures concerning currency exchange rates and interest rates - No material changes to market risk disclosures regarding currency exchange and interest rates were reported for the first six months of 2025[148](index=148&type=chunk) [Controls and Procedures](index=57&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls are effective, with ongoing integration of Biolife's internal controls not expected to cause material changes - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[149](index=149&type=chunk) - The company is in the process of integrating the internal controls of Biolife, acquired on May 20, 2025[151](index=151&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=58&type=section&id=Item%201.%20Legal%20Proceedings) An ongoing SEC inquiry regarding a China subsidiary is noted, with no other material legal proceedings expected - The company is involved in an ongoing SEC inquiry related to its subsidiary in China, as detailed in Note 10 of the financial statements[154](index=154&type=chunk)[69](index=69&type=chunk) [Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors include adverse impacts from changing trade policies and tariffs, alongside challenges associated with leadership succession - The company identifies significant risks from changes in U.S. trade policies, including increased tariffs on raw materials and finished products imported from Mexico, Ireland, and China, which could increase manufacturing costs[157](index=157&type=chunk) - A new President and CEO, Martha Aronson, has been appointed effective October 3, 2025. The company acknowledges that this leadership transition is inherently difficult and could negatively impact relationships with stakeholders or cause operational disruptions[162](index=162&type=chunk) [Other Information](index=60&type=section&id=Item%205.%20Other%20information) No directors or officers reported adopting or terminating Rule 10b5-1 trading arrangements in Q2 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan in the second quarter of 2025[165](index=165&type=chunk) [Exhibits](index=61&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Biolife merger agreement and CEO/CFO certifications - Key exhibits filed include the merger agreement for the Biolife acquisition and CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906[167](index=167&type=chunk)