TransMedics(TMDX)
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TransMedics Receives FDA IDE Approval to Initiate Next-Generation OCS Heart Trial
Prnewswire· 2025-08-04 12:00
Core Insights - TransMedics Group, Inc. has received conditional approval from the FDA for its Investigational Device Exemption (IDE) to initiate the Next-Generation OCS ENHANCE Heart trial, which aims to transform organ transplant therapy for patients with end-stage organ failure [1][3] Group 1: Trial Details - The ENHANCE trial consists of two parts: Part A focuses on prolonged heart perfusion using the OCS™ Heart System, while Part B aims to demonstrate the superiority of OCS Heart perfusion in donation after brain death (DBD) cases compared to static cold storage methods [2] - The total sample size for the ENHANCE trial is expected to exceed 650 patients, potentially making it the largest heart preservation trial for transplant globally [2] Group 2: Company Overview - TransMedics is a leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation, headquartered in Andover, Massachusetts [4] - The company was founded to address the unmet need for better organ transplantation solutions and has developed technologies to preserve organ quality and assess organ viability prior to transplant [4]
TMDX Stock Gains Post Q2 Earnings & Revenue Beat, Margins Up
ZACKS· 2025-08-01 17:11
Core Insights - TransMedics Group, Inc. (TMDX) reported a significant increase in earnings per share (EPS) of 92 cents for Q2 2025, marking a 162.9% year-over-year growth and exceeding the Zacks Consensus Estimate by 91.7% [1][6] Revenue Performance - TMDX achieved revenues of $157.4 million in Q2 2025, reflecting a 37.7% increase year-over-year and surpassing the Zacks Consensus Estimate by 6.8% [2][6] - The revenue growth was attributed to higher utilization of the Organ Care System (OCS), particularly in liver and heart transplants, and additional income from TransMedics logistics services [2][6] - Net product revenues reached $96.1 million, up 33.9% year-over-year, driven by increased organ utilization [4][6] - Service revenues totaled $61.3 million, a 43.9% increase year-over-year, primarily due to logistics services [7][6] Margin and Profitability - Operating profit for the quarter was $36.6 million, representing a 192.3% increase from the previous year, with an operating margin expansion of 1230 basis points to 23.2% [9][6] - Gross profit increased by 39.4% year-over-year to $96.6 million, with a gross margin of 61% [8][6] Financial Position - At the end of Q2 2025, TransMedics had cash reserves of $400.6 million, up from $310.1 million at the end of Q1 2025, while total long-term debt remained relatively stable at $59.5 million [10] - Cumulative net cash provided by operations was $88.8 million, significantly higher than $22.3 million at the end of Q2 2024 [10] Future Outlook - The company has raised its revenue guidance for 2025, now expecting revenues between $585 million and $605 million, indicating a 35% growth at the midpoint compared to 2024 [11] - Management highlighted ongoing expansion plans, including the upcoming OCS Kidney launch and the growth of the NOP logistics network, positioning the company for future growth [14][13]
TransMedics: Continued Strength Suggests Further Upside
Seeking Alpha· 2025-08-01 10:25
Core Insights - TransMedics (TMDX) reported strong results in the second quarter, aiding in the recovery of its share price despite ongoing concerns about seasonal weakness and competition [1] - The company's next-generation heart and lung programs are expected to provide a significant growth boost [1] Company Overview - TransMedics is focused on innovative medical solutions, particularly in organ transplantation, which positions it well for future growth opportunities [1] - The company is navigating a competitive landscape but is leveraging its unique product offerings to differentiate itself [1] Market Context - The investment landscape is characterized by an aging population, low population growth, and stagnating productivity, which may create new investment opportunities [1] - There is a trend towards asset-light businesses, leading to a decline in the need for infrastructure investments, which is affecting capital allocation in various industries [1] - A large pool of capital is pursuing a limited set of investment opportunities, resulting in rising asset prices and compressed risk premiums over time [1]
TransMedics (TMDX) Q2 Revenue Jumps 38%
The Motley Fool· 2025-07-31 09:16
Core Insights - TransMedics Group reported strong Q2 2025 earnings, exceeding Wall Street expectations with GAAP revenue of $157.4 million and GAAP EPS of $0.92, reflecting a year-over-year revenue increase of 38% [1][2] - The company raised its full-year revenue guidance to $585 million to $605 million, indicating approximately 35% growth over the previous year [14] Financial Performance - Q2 2025 GAAP revenue was $157.4 million, surpassing the estimate of $147.7 million and up from $114.3 million in Q2 2024, marking a 37.7% year-over-year increase [2] - GAAP EPS reached $0.92, significantly higher than the estimated $0.45 and up 162.9% from $0.35 in Q2 2024 [2] - Net income soared to $34.9 million, a 186.1% increase from $12.2 million in the prior year, representing 22% of revenue [2][6] Business Operations - The company focuses on two main areas: expanding the adoption of its FDA-approved Organ Care System (OCS) and scaling the National OCS Program (NOP) for organ transport logistics [4][3] - The OCS technology allows for better preservation of donor organs, leading to more successful transplants, particularly in liver and heart transplants [3][9] Revenue Breakdown - Product revenue grew by 34% year-over-year, while service revenue surged by 44%, with service revenue accounting for $61.3 million [5] - Gross margin remained stable at 61%, despite an increase in lower-margin service revenue [6] Strategic Developments - The company is investing in R&D and logistics, with cash reserves at $400.6 million and plans to expand its aircraft fleet to 22 by year-end [7][8] - The launch of the NOP ACCESS digital platform aims to enhance operational efficiency and automate billing processes [10] Regulatory and Market Position - TransMedics received conditional Investigational Device Exemption (IDE) clearance for next-generation OCS Lung trials, expected to start in the second half of 2025 [11] - The company is also expanding its manufacturing infrastructure in Italy to support international growth and ensure supply continuity [12] Reimbursement Strategies - The company emphasizes reimbursement for both the OCS device and NOP logistics services through U.S. Medicare and commercial insurers, assisting transplant centers with billing [13] Future Outlook - Management anticipates at least 400 basis points of operating margin improvement in 2025, driven by efficiency gains and scaling effects [8][14] - Increased investment in R&D and upcoming clinical trials for next-generation OCS devices are expected to contribute to long-term growth [15]
TransMedics (TMDX) Reports Q2 Earnings: What Key Metrics Have to Say
ZACKS· 2025-07-31 00:01
Core Insights - TransMedics reported a revenue of $157.37 million for the quarter ended June 2025, marking a 37.7% increase year-over-year and exceeding the Zacks Consensus Estimate of $147.37 million by 6.79% [1] - The company's EPS for the quarter was $0.92, significantly higher than the $0.35 reported in the same quarter last year, resulting in an EPS surprise of 91.67% against the consensus estimate of $0.48 [1] Revenue Performance - Geographic revenues from the United States reached $152.19 million, surpassing the average estimate of $142.05 million by four analysts, reflecting a year-over-year increase of 40.3% [4] - Revenue from all other countries was $4.16 million, slightly below the estimated $4.47 million, representing an 11.8% decline compared to the previous year [4] Product Revenue Breakdown - OCS Lung net revenue was reported at $4.15 million, which was below the average estimate of $4.5 million, indicating an 11.5% decrease year-over-year [4] - OCS Liver net revenue reached $115.86 million, exceeding the estimated $108.56 million, with a notable year-over-year increase of 50.4% [4] - OCS Heart net revenue was $32.17 million, slightly below the estimated $32.38 million, showing a modest year-over-year increase of 2.3% [4] Stock Performance - Over the past month, TransMedics' shares have returned -19.4%, contrasting with the Zacks S&P 500 composite's increase of 3.4% [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]
TransMedics (TMDX) Q2 Earnings and Revenues Surpass Estimates
ZACKS· 2025-07-30 23:06
Company Performance - TransMedics reported quarterly earnings of $0.92 per share, exceeding the Zacks Consensus Estimate of $0.48 per share, and up from $0.35 per share a year ago, representing an earnings surprise of +91.67% [1] - The company posted revenues of $157.37 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 6.79%, compared to $114.31 million in the same quarter last year [2] - Over the last four quarters, TransMedics has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times as well [2] Stock Performance - TransMedics shares have increased approximately 68.1% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.32 on revenues of $139.52 million, and for the current fiscal year, it is $1.89 on revenues of $580.37 million [7] Industry Outlook - The Medical - Instruments industry, to which TransMedics belongs, is currently ranked in the bottom 35% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of TransMedics' stock may be influenced by the overall outlook for the industry, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]
TransMedics(TMDX) - 2025 Q2 - Earnings Call Transcript
2025-07-30 21:32
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $157.4 million, representing approximately 38% year-over-year growth and about 10% sequential growth from Q1 2025 [11][40] - Gross margin for Q2 was steady at 61.4%, similar to Q1 [13] - Operating profit was approximately $36.6 million in Q2, representing more than 23% of total revenue, up from $27.4 million or 19% of total revenue in Q1 2025 [13] - Net income for Q2 was $35 million, representing a 186% year-over-year increase and 36% sequentially [44] Business Line Data and Key Metrics Changes - U.S. transplant revenue was approximately $152 million, up 40% year-over-year and 10% sequentially, with liver contributing $116 million, heart $32 million, and lung $4 million [40] - Product revenue for Q2 reached $96 million, up 34% year-over-year and 9% sequentially, driven by increasing organ utilization in liver and OCS adoption across both liver and heart [41] - Service revenue for Q2 reached $61 million, up 44% year-over-year and 11% sequentially, primarily driven by logistics revenue, which grew 56% year-over-year and 14% sequentially [41] Market Data and Key Metrics Changes - OCS Lung experienced approximately 14% sequential growth in Q2 [12] - Transplant logistics service revenue for Q2 was $29.8 million, representing 56% year-over-year and 14% sequential growth [16] Company Strategy and Development Direction - The company aims to grow OCS NOP volumes beyond the 10,000 planned for 2028 and is exploring options for international expansion [14][15] - The company is focused on expanding its infrastructure footprint and investing in R&D to advance its product pipeline, including the OCS kidney platform [33][46] - The company plans to capitalize on national modernization initiatives in the U.S. transplant system [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the evolving transplant landscape and emphasized the importance of their unique technology and logistics capabilities [70][72] - The company raised its full-year 2025 revenue guidance to between $585 million and $605 million, reflecting approximately 35% growth over 2024 at the midpoint [38][45] - Management acknowledged potential seasonality impacts in Q3 but expects a strong finish to the year [37][38] Other Important Information - The company received FDA conditional approval for the OCS Lung IDE in July and is planning to begin trial initiation activities after the summer [18] - Management addressed concerns regarding DCD donations, stating that utilization remains unchanged and that DCD is a critical part of the organ donation landscape [86][90] Q&A Session Summary Question: What are the expectations for seasonality in Q3? - Management noted some signs of seasonality in July but indicated it may be less pronounced than the previous year [54] Question: Concerns about oversight over OPOs and DCD usage? - Management believes that increased oversight could benefit the transplant market and emphasized their collaborative approach with OPOs [56][58] Question: Updates on the lung trial design? - Management confirmed that there were no substantive changes to the clinical trial design as agreed with the FDA [60] Question: Insights on the U.S. heart market? - Management indicated that the heart market has experienced fluctuations but expects normalization with the introduction of next-gen technology [64] Question: Any headwinds anticipated with the modernization of the U.S. transplant network? - Management does not foresee headwinds, citing clear data supporting their growth and alignment with stakeholder goals [72][74] Question: Feedback on NOP access? - Early feedback has exceeded expectations, and the NOP Access and NOP Connect systems are designed to work seamlessly together [100][101]
TransMedics(TMDX) - 2025 Q2 - Earnings Call Transcript
2025-07-30 21:30
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $157.4 million, representing approximately 38% year-over-year growth and about 10% sequential growth from Q1 2025 [10] - Operating profit for Q2 was approximately $36.6 million, representing more than 23% of total revenue, up from $27.4 million or 19% of total revenue in Q1 2025 [12] - Net income for Q2 was $35 million, representing a 186% year-over-year increase and 36% sequentially [43] - The company ended Q2 with over $400 million in cash, an increase of approximately $90 million from Q1 2025 [12][43] Business Line Data and Key Metrics Changes - U.S. transplant revenue was approximately $152 million, up 40% year-over-year and 10% sequentially, with liver contributing $116 million, heart $32 million, and lung $4 million [39] - Product revenue for Q2 reached $96 million, up 34% year-over-year and 9% sequentially, driven by increasing organ utilization in liver and OCS adoption across both liver and heart [40] - Service revenue for Q2 reached $61 million, up 44% year-over-year and 11% sequentially, primarily driven by logistics revenue, which grew 56% year-over-year and 14% sequentially [40] Market Data and Key Metrics Changes - OCS Lung experienced approximately 14% sequential growth in Q2 [11] - The company covered 79% of its NOP missions requiring air transport in Q2, nearly reaching its target of 80% to 85% [15] Company Strategy and Development Direction - The company aims to grow OCS NOP volumes beyond the planned 10,000 for 2028 and is exploring options for international expansion, particularly in Europe [13][14] - The company is focused on expanding its infrastructure footprint, delivering on its OCS platform pipeline, and capitalizing on national modernization initiatives [32][34] - The company plans to invest in R&D to advance its pipeline and improve operational efficiencies [45][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving and surpassing the target of 10,000 U.S. NOP transplants by 2028, with plans to exceed that in subsequent years [13] - The company raised its full-year 2025 revenue guidance to between $585 million and $605 million, reflecting approximately 35% growth over 2024 at the midpoint [36][44] - Management acknowledged the potential for seasonality in Q3 but expects a strong finish to the year [35][36] Other Important Information - The company received FDA conditional approval for the OCS Lung IDE in July and is close to reaching an agreement for the OCS Heart IDE [16] - Management emphasized the importance of transparency and collaboration with stakeholders in the U.S. transplant ecosystem [27][28] Q&A Session Summary Question: What are the signs of seasonality observed in July? - Management noted some signs of seasonality in July, but the impact appears slightly less than last year, and it is still early to establish a trend [54] Question: Concerns about oversight over OPOs and DCD usage? - Management believes that increased oversight could benefit the transplant market, especially in DCD, and sees it as an opportunity rather than a concern [56][58] Question: Updates on the lung trial and any changes in design? - Management confirmed that there were no substantive changes to the clinical trial design as agreed with the FDA [60] Question: Thoughts on the U.S. heart market and its growth? - Management indicated that the heart market has experienced fluctuations but expects normalization with the introduction of next-gen technology [64] Question: Any headwinds anticipated as the U.S. transplant network evolves? - Management does not foresee headwinds, citing clear data supporting the success of their NOP and OCS initiatives [71][72] Question: Status of DCD donations and utilization? - Management reported that DCD donation remains stable and is an essential part of the organ transplantation renaissance [85] Question: Revenue generation from the cold storage arm of the clinical trials? - Management indicated that there may be some revenue generated from logistics in the control arm, but specifics will be clarified once the trial starts [91]
TransMedics Sees Its Earnings Soar
The Motley Fool· 2025-07-30 21:06
Core Viewpoint - TransMedics reported significantly better-than-expected second-quarter financial results and raised its guidance for full-year 2025, indicating strong growth potential in the organ transplant sector [1][5]. Financial Performance - Total revenue for Q2 2025 reached $157.4 million, a 38% increase from $114.3 million in Q2 2024, exceeding expectations [2][3]. - Earnings per share rose to $0.92, a 163% increase from $0.35 in the same quarter last year, also beating projections [2][3]. - Gross margin remained stable at 61%, reflecting effective cost management in production [2][3]. - Operating expenses increased by only 6% to $60 million, allowing profits to surge to nearly $35 million, up from just over $12 million a year earlier [2][4]. Guidance and Market Reaction - TransMedics raised its sales guidance for 2025 to a range of $585 million to $605 million, an increase of $20 million from previous estimates [5]. - Following the announcement, TransMedics' stock rose over 8% in after-hours trading, indicating strong investor confidence [6]. Long-term Outlook - CEO Waleed Hassanein expressed optimism about the company's long-term prospects, aiming to surpass a target of 10,000 transplants by 2028, supported by strategic investments for expansion [8].
TransMedics(TMDX) - 2025 Q2 - Quarterly Report
2025-07-30 20:29
PART I [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Q2 2025, showing significant revenue and net income growth, alongside balance sheet expansion [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $890.5 million, driven by cash and property, while stockholders' equity grew significantly to $318.1 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $558,129 | $497,216 | | **Total Assets** | $890,522 | $804,076 | | **Total Current Liabilities** | $56,620 | $59,913 | | **Total Liabilities** | $572,421 | $575,473 | | **Total Stockholders' Equity** | $318,101 | $228,603 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company achieved strong Q2 2025 performance with total revenue growing 37.7% year-over-year to $157.4 million, resulting in net income of $34.9 million Q2 and H1 2025 vs 2024 Performance (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $157,370 | $114,305 | $300,907 | $211,155 | | **Gross Profit** | $96,589 | $69,261 | $184,817 | $129,223 | | **Income from Operations** | $36,567 | $12,508 | $64,010 | $24,929 | | **Net Income** | $34,907 | $12,194 | $60,589 | $24,391 | | **Diluted EPS** | $0.92 | $0.35 | $1.62 | $0.70 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities significantly improved to $88.8 million in H1 2025, while investing activities used $36.1 million, primarily for capital expenditures Six Months Ended June 30 Cash Flow Summary (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $88,754 | $22,283 | | **Net cash used in investing activities** | ($36,113) | ($67,935) | | **Net cash provided by financing activities** | $10,117 | $13,826 | | **Net increase (decrease) in cash** | $63,925 | ($32,061) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, revenue disaggregation, debt, legal contingencies, and subsequent events, including land purchase for a new facility - The company is a medical technology firm focused on transforming organ transplants with its Organ Care System (OCS) and National OCS Program (NOP)[26](index=26&type=chunk) U.S. OCS Transplant Revenue by Organ (in thousands) | Organ | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Lung | $4,154 | $4,243 | | Heart | $32,171 | $27,173 | | Liver | $115,862 | $77,039 | - A class action lawsuit was filed in February 2025 against the company, alleging misstatements related to business practices, with the outcome and potential losses currently unpredictable[79](index=79&type=chunk) - In July 2025, the company purchased land in Mirandola, Italy, for **$2.6 million** to build a new manufacturing and R&D facility[91](index=91&type=chunk)[100](index=100&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong financial performance driven by OCS platform adoption, particularly in U.S. liver and heart transplants, and outlines strategic initiatives including a new Italian facility - The company's growth is driven by its OCS platform, which includes FDA-approved products for heart, lung, and liver transplants, and its National OCS Program (NOP), providing a turnkey organ procurement and logistics solution[94](index=94&type=chunk)[95](index=95&type=chunk) - A strategic plan was announced to build a design and manufacturing facility in Mirandola, Italy, to support the development of the next-generation OCS platform and expand international supply capabilities[100](index=100&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) In Q2 2025, total revenue grew 37.7% year-over-year to $157.4 million, leading to a surge in operating income to $36.6 million as revenue growth outpaced expense increases Q2 2025 vs Q2 2024 Results of Operations (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $157,370 | $114,305 | $43,065 | | **Gross Profit** | $96,589 | $69,261 | $27,328 | | **Income from Operations** | $36,567 | $12,508 | $24,059 | | **Net Income** | $34,907 | $12,194 | $22,713 | - U.S. OCS transplant revenue increased by **$43.7 million** in Q2 2025 compared to Q2 2024, driven by higher sales volumes of OCS Liver and OCS Heart disposable sets and increased NOP usage[119](index=119&type=chunk) - R&D expenses increased by **$2.1 million** in Q2 2025, primarily due to higher headcount and material costs for the next-generation OCS program[123](index=123&type=chunk) - SG&A expenses increased by **$1.2 million** in Q2 2025, driven by higher stock-based compensation and professional fees, partially offset by lower NOP support and tradeshow costs[124](index=124&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$400.6 million** in cash, with operations generating **$88.8 million** in cash for the first half of the year, sufficient to fund future needs - The company's principal source of liquidity was cash of **$400.6 million** at June 30, 2025[139](index=139&type=chunk) Cash Flow Summary - Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $88,754 | $22,283 | | Net cash used in investing activities | ($36,113) | ($67,935) | | Net cash provided by financing activities | $10,117 | $13,826 | - A conditional conversion feature of the Convertible Senior Notes was triggered on June 30, 2025, making the notes convertible at the holders' option during Q3 2025 as the stock price exceeded 130% of the conversion price[150](index=150&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from interest rate changes on variable-rate debt and foreign currency fluctuations, with no material changes since the 2024 Form 10-K - The company's primary market risks are related to interest rate changes on its variable rate debt and foreign currency exchange rate fluctuations[162](index=162&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of June 30, 2025, due to a material weakness in internal control over financial reporting related to inventory movement - A material weakness was identified in internal control over financial reporting because the company has not designed and maintained effective controls over inventory movement within its manufacturing network[165](index=165&type=chunk) - Despite the material weakness, management concluded that the condensed consolidated financial statements included in the report are fairly presented in all material respects[165](index=165&type=chunk) - Management is in the process of finalizing a remediation plan to address the material weakness, which will involve designing and implementing new controls for inventory movement[166](index=166&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending against a consolidated class action lawsuit filed in early 2025, alleging misstatements regarding business practices and billing activities - A class action lawsuit (Jewik v. TransMedics Group, Inc., et al.) was filed on February 14, 2025, and later consolidated with a similar suit[170](index=170&type=chunk) - The complaint alleges violations of the Securities Exchange Act based on purported misstatements and omissions regarding coercive business tactics, anticompetitive conduct, and fraudulent billing[170](index=170&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section refers investors to the company's 2024 Form 10-K for a comprehensive discussion of risks and uncertainties affecting the business - For a detailed discussion of risk factors, the report refers to "Item 1A. Risk Factors" in the company's 2024 Form 10-K[173](index=173&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of its equity securities during the reporting period - None[174](index=174&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) During the fiscal quarter ended June 30, 2025, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement - No director or officer adopted or terminated a Rule 10b5-1 trading plan during the quarter[175](index=175&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the 10-Q report, including CEO and CFO certifications and Inline XBRL financial data files - The exhibits filed with this report include CEO and CFO certifications pursuant to Sarbanes-Oxley Act rules and XBRL data files[176](index=176&type=chunk)