Core Viewpoint - TransMedics (TMDX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system tracks earnings estimate revisions, which are strongly correlated with stock price movements, particularly due to institutional investors' reliance on these estimates for valuation [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations for stocks, prompting institutional buying or selling, which subsequently affects stock prices [4]. Company Performance Indicators - For the fiscal year ending December 2025, TransMedics is projected to earn $1.90 per share, reflecting an 88.1% increase from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for TransMedics has risen by 32.4%, indicating a positive trend in earnings expectations [8]. Zacks Rating System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, suggesting superior earnings estimate revisions [9][10]. - The upgrade of TransMedics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating potential for market-beating returns in the near term [10].

Group 1: TransMedics Group - TransMedics Group has developed an innovative Organ Care System (OCS) that significantly improves organ storage before transplants, achieving an 81% usage rate for hearts compared to 32% for traditional cold storage [4] - The company has faced challenges, including slowed revenue growth and disappointing guidance, alongside serious allegations from an activist short-seller [5] - Despite recent issues, TransMedics Group's stock rose approximately 20% following stronger-than-expected first-quarter results, although shares are still down 11% over the past year, indicating potential for significant upside in the next five years [6][7] Group 2: Exact Sciences - Exact Sciences specializes in cancer diagnostic tests, notably Cologuard, a non-invasive test for colorectal cancer, which is the second leading cause of cancer death globally [8] - The company has made substantial progress in the screening market, with Cologuard being used to screen 10 million patients by 2022 since its U.S. clearance in 2014 [9] - Recent advancements include the approval of Cologuard Plus, which is more effective and cheaper to manufacture, and the launch of Oncodetect for cancer recurrence checks, with plans for a multicancer-detecting test called Cancerguard later this year [10][11][12]

Core Insights - TransMedics Group's stock experienced a significant increase of approximately 81% from the end of 2024 to May 12, 2025, following a strong first-quarter earnings report that exceeded investor expectations [1][2] - The company faced challenges in late 2024 due to downward revenue guidance and scrutiny from short-sellers, but recent developments indicate a positive outlook [1][4] Financial Performance - In 2024, TransMedics reported an annual revenue growth of 83%, but management projected a slowdown to 20% to 25% growth for the current year [4] - The first-quarter results showed a 62% year-over-year increase in liver revenue, which is crucial as liver transplantation accounts for 76% of the company's total revenue [6][7] Market Position and Competition - TransMedics' organ care system (OCS) is the only FDA-approved device for transporting multiple organs, although it faces competition from OrganOx, which has raised $160 million to enhance its liver device [5][6][7] - Despite the competitive threat, TransMedics raised its revenue guidance for the year to between $565 million and $585 million, indicating a potential 30% gain at the midpoint [8] Industry Trends - The total number of heart, lung, and liver transplants in the U.S. increased by 20% over the past two years, with TransMedics contributing significantly to this growth [9] - The company has increased its market share for hearts, lungs, and livers from 7% in 2022 to 21% in 2024, suggesting strong potential for continued growth [11] Valuation Considerations - TransMedics' stock is currently trading at 8.5 times its trailing-12-month sales, which is considered high for a medical device company, but may be justified if the company can sustain a growth rate of around 20% annually in the coming decade [12]

Core Insights - TransMedics Group, Inc. (TMDX) reported a significant increase in earnings per share (EPS) of 70 cents for Q1 2025, marking a 100% year-over-year growth and exceeding the Zacks Consensus Estimate by 141.4% [1] - The company's revenues reached $143.5 million in Q1 2025, reflecting a 48.2% increase year-over-year and surpassing the Zacks Consensus Estimate by 16.2% [1] Revenue Breakdown - TMDX's revenue sources include Net product revenue and Service revenue, with Net product revenues totaling $88.2 million, up 43.9% year-over-year, driven by increased organ utilization in liver and heart [3] - Service revenues amounted to $55.3 million, up 55.7% year-over-year, primarily due to logistics services [3] - Transplant Logistics services revenues were $26.1 million, representing an 80% year-over-year increase, attributed to the expansion of TransMedics' aviation fleet [4] Margin and Profitability - Gross profit for the quarter increased by 47.1% year-over-year to $88.2 million, although gross margin contracted by 45 basis points to 61.5% [5] - Operating profit reached $27.4 million, reflecting a 120.9% increase from the prior-year quarter, with the operating margin expanding by 629 basis points to 19.1% [6] Financial Position - At the end of Q1 2025, TransMedics had cash reserves of $310.1 million, down from $336.7 million at the end of 2024, with total long-term debt remaining stable at $59.4 million [7] - Net cash used in operating activities was $2.9 million, a slight decrease from $3.4 million a year ago [7] Future Outlook - TransMedics has raised its revenue guidance for 2025, now expecting revenues between $565 million and $585 million, which reflects a 30% growth at the midpoint compared to 2024 figures [9] - The previous revenue outlook was between $530 million and $552 million, indicating a growth of 20-25% from 2024 [9] Strategic Developments - The company plans to open a new disposables manufacturing facility in Mirandola, Italy, to ensure business continuity and is set to launch two new heart and lung clinical programs later in the year [11]

Group 1 - TransMedics (TMDX) reported extremely strong Q1 results, reflecting the positive trends in transplant volumes and flight activity [1] - Growth may show volatility on a quarterly basis, and competition is expected to increase in the near future [1] Group 2 - Narweena, an asset manager, focuses on identifying market dislocations due to misunderstandings of long-term business prospects [1] - The firm aims for excess risk-adjusted returns by targeting businesses with secular growth opportunities in markets with entry barriers [1] - Narweena's investment strategy emphasizes company and industry fundamentals to uncover unique insights, with a preference for smaller cap stocks [1] Group 3 - The aging population, low population growth, and stagnating productivity growth are expected to create new investment opportunities [1] - Some industries may face stagnation or secular decline, which could paradoxically enhance business performance due to reduced competition [1] - The economy is increasingly influenced by asset-light businesses, leading to a declining need for infrastructure investments [1] Group 4 - A large pool of capital is pursuing a limited set of investment opportunities, resulting in rising asset prices and compressed risk premia over time [1] - Richard Durant, the leader of Narweena, holds degrees in engineering and finance, along with an MBA, and has passed the CFA exams [1]

Financial Performance - For the quarter ended March 2025, TransMedics reported revenue of $143.54 million, reflecting a 48.2% increase year-over-year [1] - The earnings per share (EPS) was $0.70, up from $0.35 in the same quarter last year [1] - The reported revenue exceeded the Zacks Consensus Estimate of $123.56 million by 16.17% [1] - The company delivered an EPS surprise of 141.38%, with the consensus EPS estimate being $0.29 [1] Key Metrics - TransMedics' shares returned 27.1% over the past month, outperforming the Zacks S&P 500 composite's 11.3% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market [3] Geographic Revenue Breakdown - Revenue from the United States was $138.62 million, surpassing the average estimate of $119.11 million, representing a year-over-year increase of 50.9% [4] - Revenue from all other countries was $4.07 million, slightly below the average estimate of $4.21 million, showing a year-over-year decline of 0.6% [4] OCS Product Revenue - OCS Lung net revenue was $4.01 million, below the average estimate of $5.19 million, reflecting a year-over-year decrease of 29.2% [4] - OCS Liver net revenue reached $108.86 million, exceeding the average estimate of $87.87 million, marking a 62.7% increase year-over-year [4] - OCS Heart net revenue was $29.82 million, slightly below the average estimate of $30.01 million, indicating a year-over-year increase of 27.8% [4]

分组1 - TransMedics reported quarterly earnings of $0.70 per share, exceeding the Zacks Consensus Estimate of $0.29 per share, and showing an increase from $0.35 per share a year ago, resulting in an earnings surprise of 141.38% [1] - The company achieved revenues of $143.54 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 16.17%, compared to $96.85 million in the same quarter last year [2] - TransMedics has outperformed the S&P 500, with shares increasing approximately 53.7% since the beginning of the year, while the S&P 500 has declined by 4.3% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is $0.38 on revenues of $133.93 million, and for the current fiscal year, it is $1.56 on revenues of $543.97 million [7] - The Medical - Instruments industry, to which TransMedics belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $143.5 million, representing approximately 48% year-over-year growth and 18% sequential growth from Q4 2024 [9] - TransMedics transplant services revenue for Q1 was approximately $55.3 million, up from $35.5 million in Q1 2024, representing approximately 56% year-over-year growth [10] - Operating profit for Q1 was $27.4 million, representing approximately 19% of total revenue, up from $8.6 million or 7% of total revenue in Q4 2024 [10][26] - Net income for the quarter was $25.7 million, representing a 111% year-on-year increase and 275% sequentially [26] Business Line Data and Key Metrics Changes - U.S. transplant revenue was $139 million, up 51% year-over-year and 19% sequentially, with liver contributing $109 million, heart $26 million, and lung $4 million [21] - Product revenue for Q1 reached $88 million, up 44% year-over-year and 18% sequentially, driven by increased organ utilization in liver and continued OCS adoption [22] - Transplant logistics services revenue for Q1 was $26.1 million, representing approximately 80% year-over-year and 20% sequential growth [11] Market Data and Key Metrics Changes - The company achieved a new high watermark for overall case volume in Q1 2025, indicating strong market penetration and utilization of OCS technology [9] - Daily average aircraft availability was approximately 15.4, up from 14 in Q4 2024, covering 78% of NOP emissions requiring air transport [11] Company Strategy and Development Direction - The company plans to launch two new heart and lung clinical programs later in the year to catalyze growth in 2026 and beyond [12] - A strategic plan to open a disposable design center of excellence and a new manufacturing facility in Mirandola, Italy, aims to leverage local expertise and ensure business continuity [17][96] - The company is focused on vertically integrating critical technology blocks to minimize supply chain risks [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining momentum throughout 2025, despite potential quarterly variability and seasonality [19] - The company raised its full-year 2025 revenue guidance to between $565 million and $585 million, representing approximately 28% to 32% growth over 2024 [19][27] - Management believes organ transplantation is largely insulated from economic cycles, reinforcing confidence in the business model [18] Other Important Information - Total operating expenses for Q1 were approximately $61 million, up 28% year-over-year, driven by increased R&D and SG&A expenses [25] - The company ended the quarter with $310 million in cash, down $26.5 million from the end of 2024 [26] Q&A Session Summary Question: What are the main drivers of growth in liver? - Management highlighted confidence in the liver platform, noting growth across both DVD and DCD organ utilization and gaining market share [35][36] Question: What is the outlook for April and beyond? - Management indicated that while they expect continued momentum, they are cautious about potential headwinds in Q2 or Q3 [38] Question: How will the next-gen products impact margins during trials? - Management expressed confidence in incurring product revenue during the trials but remained cautious about service revenue until trial designs are finalized [42][43] Question: What is the impact of competitors entering the liver market? - Management emphasized the superior results of their liver platform and the need for competitors to prove their value [44][46] Question: What is the reason for the increase in receivables? - Management attributed the increase to the timing of billing and expected recovery in Q2 [53][54] Question: How does the company view pricing in a competitive environment? - Management stated that the focus should be on the value delivered rather than pricing, emphasizing the economic efficiencies provided by their technology [63][65] Question: What are the expectations for operating margin expansion? - Management indicated that the majority of operating margin increases will come from gains in operating leverage, with planned investments later in the year [69] Question: What is the rationale for opening a facility in Mirandola, Italy? - Management noted that Mirandola is a hub for perfusion technologies and offers significant engineering talent necessary for their products [95][96]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $143.5 million, representing approximately 48% year-over-year growth and 18% sequential growth from Q4 2024 [7] - TransMedics' transplant services revenue for Q1 was approximately $55.3 million, up from $35.5 million in Q1 2024, reflecting approximately 56% year-over-year growth and 18.5% sequential growth [8] - Operating profit for Q1 was $27.4 million, representing approximately 19% of total revenue, up from $8.6 million or 7% of total revenue in Q4 2024 [8][22] - Net income for the quarter was $25.7 million, representing a 111% year-on-year increase and 275% sequentially [23] - Earnings per share were $0.76, and diluted earnings per share were $0.70 for Q1 2025 [25] Business Line Data and Key Metrics Changes - U.S. transplant revenue was $139 million, up 51% year-over-year and 19% sequentially, with liver contributing $109 million, heart $26 million, and lung $4 million [19] - Product revenue for Q1 reached $88 million, up 44% year-over-year and 18% sequentially, driven by increased organ utilization in liver and continued OCS adoption [20] - Transplant logistics services revenue for Q1 was $26.1 million, representing approximately 80% year-over-year and 20% sequential growth [9] Market Data and Key Metrics Changes - The company achieved a new high watermark for overall case volume in Q1 2025, indicating strong market demand [7] - The average daily aircraft availability was approximately 15.4, up from 14 in Q4 2024, covering 78% of NOP emissions requiring air transport [9] Company Strategy and Development Direction - The company plans to launch two new heart and lung clinical programs later in 2025 to catalyze growth in 2026 and beyond [10] - A strategic plan to open a disposable design center of excellence and a new manufacturing facility in Mirandola, Italy, aims to leverage local expertise and ensure business continuity [14][95] - The company is focused on vertically integrating critical technology blocks to minimize supply chain risks [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining momentum throughout 2025, despite potential quarterly variability and seasonality [17][26] - The company raised its full-year 2025 revenue guidance to between $565 million and $585 million, reflecting approximately 28% to 32% growth over 2024 [17][25] - Management believes organ transplantation is largely insulated from economic cycles due to its lifesaving nature and cost-effectiveness [16] Other Important Information - Total operating expenses for Q1 were approximately $61 million, up 28% year-over-year, primarily driven by a 51% increase in R&D [22] - The company ended the quarter with $310 million in cash, down $26.5 million from the end of 2024 [24] Q&A Session Summary Question: What are the main drivers of growth in liver? - Management highlighted increased utilization of deceased donors across both DVD and DCD, gaining share and momentum in the liver platform [34][36] Question: What is the outlook for April and beyond? - Management indicated confidence in maintaining momentum but acknowledged potential variability between quarters [37][38] Question: How will clinical trials impact product and service margins? - Management expressed confidence in incurring product revenue during trials but remained cautious about service revenue on the control arm [42] Question: What is the impact of competitors entering the liver market? - Management emphasized the superior results of the OCS Liver platform and the need for competitors to prove their value [44][46] Question: What is the reason for the increase in receivables? - Management attributed the increase to the timing of billing and expected recovery in Q2 [53][54] Question: How does the company view pricing in a competitive environment? - Management stated that the focus should be on the value delivered rather than pricing, emphasizing the economic efficiency of their technology [62][65] Question: What are the expectations for operating margin expansion? - Management indicated that the majority of operating margin increases would be driven by gains in operating leverage, with planned investments for later in the year [69] Question: What is the rationale for opening a facility in Mirandola, Italy? - Management noted that Mirandola is a hub for perfusion technologies and offers significant engineering talent necessary for their products [95][96]

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents TransMedics Group's unaudited condensed consolidated financial statements and explanatory notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Total Assets | $837,530 | $804,076 | | Total Liabilities | $571,222 | $575,473 | | Total Stockholders' Equity | $266,308 | $228,603 | | Cash | $310,143 | $336,650 | | Accounts receivable | $142,026 | $97,722 | | Inventory | $43,380 | $46,554 | | Property, plant and equipment, net | $311,244 | $285,970 | | Convertible senior notes, net | $450,650 | $449,939 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations Highlights (Three Months Ended March 31, in thousands, except per share amounts) | Metric | 2025 | 2024 | Change (YoY) | % Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | :------------- | | Total revenue | $143,537 | $96,850 | $46,687 | 48.2% | | Gross profit | $88,228 | $59,962 | $28,266 | 47.1% | | Income from operations | $27,443 | $12,421 | $15,022 | 120.9% | | Net income | $25,682 | $12,197 | $13,485 | 110.5% | | Diluted Net income per share | $0.70 | $0.35 | $0.35 | 100.0% | [Condensed Consolidated Statements of Comprehensive Income](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) Condensed Consolidated Statements of Comprehensive Income Highlights (Three Months Ended March 31, in thousands) | Metric | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | Net income | $25,682 | $12,197 | $13,485 | | Foreign currency translation adjustment | $37 | $17 | $20 | | Comprehensive income | $25,719 | $12,214 | $13,505 | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) - Total stockholders' equity increased to **$266,308 thousand** as of March 31, 2025, from **$228,603 thousand** at December 31, 2024, primarily driven by net income of **$25,682 thousand** and stock-based compensation expense of **$8,958 thousand**[21](index=21&type=chunk) - The number of common stock shares issued and outstanding increased to **33,827,880 shares** as of March 31, 2025, from **33,617,972 shares** as of December 31, 2024[16](index=16&type=chunk)[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows Highlights (Three Months Ended March 31, in thousands) | Metric | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | Net cash used in operating activities | $(2,855) | $(3,435) | $580 | | Net cash used in investing activities | $(27,038) | $(44,172) | $17,134 | | Net cash provided by financing activities | $3,028 | $3,185 | $(157) | | Net decrease in cash and restricted cash | $(26,507) | $(44,595) | $18,088 | | Cash and restricted cash, end of period | $310,643 | $350,717 | $(40,074) | - The decrease in net cash used in investing activities was primarily due to lower purchases of property, plant and equipment, specifically transplant aircraft[127](index=127&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes on the company's business, accounting policies, and specific financial line items [Note 1. Nature of the Business and Basis of Presentation](index=10&type=section&id=Note%201.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) This note describes TransMedics' medical technology business, OCS platform, NOP services, and liquidity outlook - TransMedics Group, Inc. is a medical technology company focused on transforming organ transplant therapy for end-stage organ failure patients using its Organ Care System (OCS) and National OCS Program (NOP)[26](index=26&type=chunk) - The OCS technology replicates the organ's natural living environment outside the body, enabling organ optimization and assessment[26](index=26&type=chunk) - The NOP provides outsourced organ procurement, OCS perfusion management, and transplant logistics services, including aviation and ground transportation[26](index=26&type=chunk) - The Company believes its existing cash of **$310.1 million** as of March 31, 2025, will be sufficient to fund operations, capital expenditures, and debt service for at least the next **12 months**[27](index=27&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the accounting principles, management estimates, supplier dependencies, and impact of new accounting pronouncements - The unaudited interim financial statements are prepared in conformity with GAAP, with certain information condensed or omitted per SEC rules for interim reporting[30](index=30&type=chunk) - Management makes significant estimates and assumptions, including for revenue recognition, inventory valuation, business combinations, and stock-based awards, which are evaluated on an ongoing basis[31](index=31&type=chunk) - The Company relies on sole, single, or limited sources for certain product components, subassemblies, and sterilization services, posing a risk of adverse impact if these sources are lost[33](index=33&type=chunk) - The Company is assessing the impact of recently issued accounting pronouncements: ASU 2023-09 (Income Tax Disclosures, effective FY2025) and ASU 2024-03 (Expense Disaggregation Disclosures, effective FY2026/2027)[40](index=40&type=chunk)[41](index=41&type=chunk) [Note 3. Inventory](index=12&type=section&id=Note%203.%20Inventory) This note details the composition of inventory, including raw materials, work-in-process, and finished goods Inventory Composition (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :--------------- | :------------- | :---------------- | | Raw materials | $24,949 | $28,027 | | Work-in-process | $3,791 | $3,274 | | Finished goods | $14,640 | $15,253 | | **Total Inventory** | **$43,380** | **$46,554** | - Spare parts inventory of **$4.0 million** is included within prepaid expenses and other current assets for both periods, with no allowance for excess and obsolescence[37](index=37&type=chunk) [Note 4. Property, Plant and Equipment, Net](index=13&type=section&id=Note%204.%20Property,%20Plant%20and%20Equipment,%20Net) This note provides a breakdown of property, plant, and equipment, including transplant aircraft and OCS Consoles Property, Plant and Equipment, Net (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Transplant aircraft | $280,768 | $252,090 | | OCS Consoles | $20,478 | $19,193 | | Manufacturing equipment | $11,076 | $10,496 | | Construction-in-progress | $7,438 | $6,658 | | Less: Accumulated depreciation and amortization | $(46,891) | $(40,714) | | **Total Property, Plant and Equipment, Net** | **$311,244** | **$285,970** | - Total depreciation and amortization expense was **$6.1 million** for the three months ended March 31, 2025, up from **$4.3 million** in the prior year period[44](index=44&type=chunk) - The Company capitalized **$1.8 million** in costs associated with internal use software development in Q1 2025, included in construction-in-progress[44](index=44&type=chunk) [Note 5. Goodwill and Intangible Assets](index=13&type=section&id=Note%205.%20Goodwill%20and%20Intangible%20Assets) This note details the company's goodwill and acquired intangible assets, including customer relationships and amortization expenses - Goodwill remained at **$11.5 million** as of March 31, 2025, with no impairments recorded to date[46](index=46&type=chunk) Acquired Intangible Assets, Net (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Customer relationship | $2,006 | $2,055 | | Other | $95 | $97 | | **Total** | **$2,101** | **$2,152** | - Amortization expense for intangible assets was **$0.1 million** for both the three months ended March 31, 2025, and 2024[48](index=48&type=chunk) - Future amortization expense is projected to be **$152 thousand** for the remaining nine months of 2025, and **$203 thousand** annually from 2026 to 2029[48](index=48&type=chunk) [Note 6. Accrued Expenses and Other Current Liabilities](index=14&type=section&id=Note%206.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note provides a breakdown of accrued expenses and other current liabilities, including payroll and transportation costs Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :---------------- | | Accrued payroll and related expenses | $13,846 | $22,523 | | Accrued transportation costs | $3,650 | $3,818 | | Accrued research, development and clinical trials expenses | $4,863 | $4,179 | | Accrued professional fees | $4,003 | $2,445 | | Accrued other | $13,777 | $12,187 | | **Total** | **$40,139** | **$45,152** | [Note 7. Long-Term Debt and Financing Arrangements](index=14&type=section&id=Note%207.%20Long-Term%20Debt%20and%20Financing%20Arrangements) This note details the company's convertible senior notes, long-term debt, and associated capped call transactions - The Company has **$460.0 million** aggregate principal amount of **1.50%** convertible senior notes due 2028, with an initial conversion price of approximately **$94.00 per share**[50](index=50&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - The estimated fair value of the convertible senior notes was **$504.9 million** as of March 31, 2025[50](index=50&type=chunk) - The Company also has **$60.0 million** in long-term debt under a credit agreement with CIBC, bearing a variable interest rate (**6.3%** as of March 31, 2025)[59](index=59&type=chunk)[60](index=60&type=chunk)[63](index=63&type=chunk) - The Company was in compliance with all financial covenants of the CIBC Credit Agreement as of March 31, 2025[62](index=62&type=chunk) - In connection with the convertible notes, the Company entered into capped call transactions costing **$52.1 million**, intended to reduce potential dilution, with an initial cap price of **$141.88 per share**[57](index=57&type=chunk)[58](index=58&type=chunk) [Note 8. Stock-Based Compensation](index=16&type=section&id=Note%208.%20Stock-Based%20Compensation) This note details stock-based compensation expense, available shares under incentive plans, and unrecognized compensation costs - Total stock-based compensation expense increased to **$8,958 thousand** for the three months ended March 31, 2025, from **$6,870 thousand** in the prior year period[70](index=70&type=chunk) - As of March 31, 2025, **436,485 shares** were available under the 2019 Stock Incentive Plan and **427,410 shares** under the 2021 Inducement Plan[65](index=65&type=chunk)[66](index=66&type=chunk) - During Q1 2025, the Company granted options for **286,732 shares** (weighted average grant-date fair value of **$49.16**) and **325,064 Restricted Stock Units** (weighted average grant-date fair value of **$75.18**)[68](index=68&type=chunk)[69](index=69&type=chunk) - Total unrecognized compensation cost related to unvested share-based awards was **$83.4 million** as of March 31, 2025, to be recognized over a weighted average period of **2.5 years**[70](index=70&type=chunk) [Note 9. Net Income (Loss) per Share](index=19&type=section&id=Note%209.%20Net%20Income%20(Loss)%20per%20Share) This note presents basic and diluted net income per share, including weighted average shares outstanding and dilutive securities Net Income per Share (Three Months Ended March 31) | Metric | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Basic Net income per share | $0.76 | $0.37 | | Diluted Net income per share | $0.70 | $0.35 | | Weighted average basic common shares outstanding | 33,721,603 | 32,760,190 | | Weighted average dilutive common shares outstanding | 39,914,487 | 34,678,895 | - Dilutive securities for Q1 2025 included **4,893,805 shares** from convertible senior notes, **1,200,858 shares** from options, and **98,221 shares** from restricted stock units[73](index=73&type=chunk) - Anti-dilutive securities excluded from diluted EPS calculation for Q1 2025 totaled **1,109,401 shares**, including options, ESPP, RSUs, and restricted stock awards[73](index=73&type=chunk) [Note 10. Commitments and Contingencies](index=20&type=section&id=Note%2010.%20Commitments%20and%20Contingencies) This note outlines the company's 401(k) contributions, purchase commitments, and pending class action lawsuits - The Company's 401(k) savings plan employer matching contributions were **$1.1 million** for Q1 2025, up from **$0.6 million** in Q1 2024[76](index=76&type=chunk) - An unconditional purchase commitment for goods has a remaining obligation of **$5.0 million** as of March 31, 2025, extending through December 2029[79](index=79&type=chunk) - Two class action lawsuits were filed in Q1 2025 (Jewik v. TransMedics Group, Inc., et al., and Collins v. TransMedics Group, Inc., et al.) alleging misstatements, coercive business tactics, anticompetitive conduct, and fraudulent billing; motions for consolidation are pending[80](index=80&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - The Company is currently unable to predict the outcome of the class action litigation or reasonably estimate a range of possible losses[81](index=81&type=chunk) [Note 11. Revenue and Segment Information](index=21&type=section&id=Note%2011.%20Revenue%20and%20Segment%20Information) This note provides OCS transplant revenue by organ and country, and discusses the company's single operating segment OCS Transplant Revenue by Organ and Country (Three Months Ended March 31, in thousands) | Category | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | **United States** | | | | | Lung total revenue | $3,636 | $4,706 | $(1,070) | | Heart total revenue | $26,266 | $20,224 | $6,042 | | Liver total revenue | $108,715 | $66,926 | $41,789 | | **Total United States OCS transplant revenue** | **$138,617** | **$91,856** | **$46,761** | | **All other countries** | | | | | Lung revenue | $375 | $960 | $(585) | | Heart revenue | $3,550 | $3,131 | $419 | | Liver revenue | $140 | $0 | $140 | | **Total all other countries OCS transplant revenue** | **$4,065** | **$4,091** | **$(26)** | | **Total OCS transplant revenue** | **$142,682** | **$95,947** | **$46,735** | - The Company manages its operations as a single segment, with the Chief Executive Officer serving as the chief operating decision maker[85](index=85&type=chunk) - Operating expenses related to post-approval studies or existing standard-of-care protocols were **$1.3 million** for Q1 2025, down from **$1.5 million** in Q1 2024[84](index=84&type=chunk) [Note 12. Related Party Transactions](index=22&type=section&id=Note%2012.%20Related%20Party%20Transactions) This note discloses compensation paid to a related party for services as Product Director for the OCS Lung program - Dr. Amira Hassanein, sister of the CEO, received **$0.4 million** in total compensation for her services as Product Director for the OCS Lung program in Q1 2025, up from **$0.1 million** in Q1 2024[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results of operations for Q1 2025 versus Q1 2024 [Overview](index=23&type=section&id=Overview) This section provides an overview of TransMedics' business, OCS technology, NOP, and future expenditure expectations - TransMedics is a medical technology company focused on transforming organ transplant therapy with its FDA-approved, portable, multi-organ, warm perfusion technology platform (OCS) for heart, lung, and liver, and its National OCS Program (NOP)[91](index=91&type=chunk)[92](index=92&type=chunk) - The Company recently achieved profitability, reporting net income of **$25.7 million** on total revenue of **$143.5 million** for the three months ended March 31, 2025[94](index=94&type=chunk) - Future operating and capital expenditures are expected to increase due to commercial sales growth, NOP expansion, manufacturing scaling, next-gen OCS development, and regulatory efforts[94](index=94&type=chunk) - The impact of HRSA initiatives and the U.S. Organ Procurement and Transplantation Network Act on the Company's business, including the NOP, is currently uncertain[96](index=96&type=chunk) [Economic Impacts](index=24&type=section&id=Economic%20Impacts) This section discusses potential adverse impacts from inflation, trade policies, tariffs, and global economic volatility - Inflation, changes in trade policies, and tariffs could adversely impact raw material prices, component availability, and shipping costs, with tariffs expected to moderately increase cost of revenue in 2025[97](index=97&type=chunk) - Global economic volatility, including in commodity, material, and labor costs, and supply chain interruptions, creates risks for demand, pricing, and inventory forecasting[97](index=97&type=chunk) [Key Components of Our Results of Operations](index=24&type=section&id=Key%20Components%20of%20Our%20Results%20of%20Operations) This section outlines the primary drivers of revenue, cost of revenue, gross profit, operating expenses, and other income/expense [Revenue](index=24&type=section&id=Revenue) This section details revenue sources from OCS disposable sets and NOP services, including international sales and growth drivers - Net product revenue is primarily generated from sales of single-use OCS disposable sets, while service revenue comes from outsourced organ procurement, OCS perfusion management, and transplant logistics services under the NOP[98](index=98&type=chunk) - The acquisition of Summit Aviation, Inc. in August 2023 has increased service revenue from transplant logistics[98](index=98&type=chunk) - International sales are dependent on maintaining CE mark certifications (recertified for OCS Heart, Lung, and Liver in 2022/2023) and Health Canada licenses (OCS Liver in October 2023)[101](index=101&type=chunk) - Long-term revenue growth is anticipated from continued NOP expansion in the U.S. and increased non-U.S. sales driven by reimbursement, higher OCS utilization, and broader adoption by transplant centers[102](index=102&type=chunk) [Cost of Revenue, Gross Profit and Gross Margin](index=25&type=section&id=Cost%20of%20Revenue,%20Gross%20Profit%20and%20Gross%20Margin) This section explains the components of cost of revenue for products and services, and factors influencing gross margin - Cost of net product revenue includes components of OCS Consoles, disposable sets, direct materials, labor, and manufacturing overhead[103](index=103&type=chunk) - Cost of service revenue primarily consists of labor and overhead for organ procurement, OCS perfusion management, and transportation/logistics costs, including aviation-related expenses[103](index=103&type=chunk) - Overall gross margin is influenced by the mix of product and service revenue, as they have different margin profiles[104](index=104&type=chunk) - The Company expects product gross margin to moderately increase over the long term due to economies of scale, product enhancements, and improved manufacturing efficiency, with modest improvements also expected in service gross margin[105](index=105&type=chunk) [Operating Expenses](index=26&type=section&id=Operating%20Expenses) This section discusses trends in research, development, clinical trials, and selling, general, and administrative expenses - Research, development, and clinical trials expenses are expensed as incurred and are expected to increase long-term due to ongoing product development, next-generation OCS efforts, and regulatory approval activities[106](index=106&type=chunk)[107](index=107&type=chunk) - Selling, general, and administrative expenses are expected to increase long-term as the Company expands its headcount to support continued sales growth of OCS products and the NOP[108](index=108&type=chunk) [Other Income (Expense)](index=26&type=section&id=Other%20Income%20(Expense)) This section covers interest expense from debt, interest income from cash, and foreign currency transaction gains/losses - Interest expense includes costs associated with the **$60.0 million** CIBC loan and the **$460.0 million** convertible senior notes[109](index=109&type=chunk) - Interest income and other income (expense), net, comprises interest earned on cash balances and realized/unrealized foreign currency transaction gains and losses[110](index=110&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the company's financial performance for Q1 2025 versus Q1 2024 [Comparison of the Three Months Ended March 31, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20March%2031,%202025%20and%202024) - Total revenue increased by **$46.7 million** (**48.2%**) to **$143.5 million** in Q1 2025, primarily driven by higher sales volumes of OCS Liver and OCS Heart disposable sets and increased usage of the NOP in the United States[112](index=112&type=chunk)[115](index=115&type=chunk) - Net income increased by **$13.5 million** (**110.5%**) to **$25.7 million** in Q1 2025[112](index=112&type=chunk) - Overall gross margin decreased from **62%** in Q1 2024 to **61%** in Q1 2025, mainly due to a relative increase in lower-margin service revenue[118](index=118&type=chunk) - Research, development, and clinical trials expenses increased by **$5.8 million** (**50.8%**) to **$17.2 million**, driven by increased headcount, laboratory supplies, and consulting for the next-generation OCS program[112](index=112&type=chunk)[119](index=119&type=chunk) - Selling, general, and administrative expenses increased by **$7.5 million** (**20.6%**) to **$43.6 million**, primarily due to team expansion, higher stock-based compensation, and increased professional/legal fees related to an independent review[112](index=112&type=chunk)[120](index=120&type=chunk) - Interest income decreased by **$1.5 million** to **$2.3 million** in Q1 2025, attributed to lower yields and cash balances[122](index=122&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section analyzes the company's cash flows, debt, funding requirements, and material contractual obligations [Cash Flows](index=29&type=section&id=Cash%20Flows) Cash Flow Summary (Three Months Ended March 31, in thousands) | Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(2,855) | $(3,435) | | Net cash used in investing activities | $(27,038) | $(44,172) | | Net cash provided by financing activities | $3,028 | $3,185 | | Net decrease in cash and restricted cash | $(26,507) | $(44,595) | - Operating activities used **$2.9 million** in Q1 2025, primarily due to a **$44.4 million** increase in operating assets and liabilities (mainly accounts receivable), partially offset by net income and non-cash charges[125](index=125&type=chunk) - Investing activities used **$27.0 million** in Q1 2025, mainly for purchases of transplant aircraft, a decrease from **$44.2 million** in Q1 2024[127](index=127&type=chunk) - Financing activities provided **$3.0 million** in Q1 2025, primarily from common stock issuance upon stock option exercise and the employee stock purchase plan[128](index=128&type=chunk) [Convertible Senior Notes](index=31&type=section&id=Convertible%20Senior%20Notes) This section details the company's $460.0 million convertible senior notes, their conversion price, and redemption terms - The Company issued **$460.0 million** aggregate principal amount of **1.50%** convertible senior notes in May 2023, maturing on June 1, 2028[130](index=130&type=chunk)[131](index=131&type=chunk) - The initial conversion price is approximately **$94.00 per share**, representing a **32.5%** premium over the common stock's closing price on May 8, 2023[131](index=131&type=chunk) - The notes are not redeemable before June 8, 2026, but may be redeemed thereafter if the common stock price meets certain thresholds[133](index=133&type=chunk) [Long-Term Debt](index=32&type=section&id=Long-Term%20Debt) This section describes the $60.0 million credit agreement with CIBC, its variable interest rate, and compliance with covenants - The Company has a **$60.0 million** credit agreement with CIBC, entered into in July 2022, with borrowings bearing a variable interest rate[134](index=134&type=chunk)[135](index=135&type=chunk) - All obligations under the CIBC Credit Agreement are secured by substantially all of the Company's and its guarantors' assets, including intellectual property[136](index=136&type=chunk) - The Company was in compliance with all financial covenants, including minimum liquidity and total net revenue requirements, as of March 31, 2025[136](index=136&type=chunk) [Funding Requirements](index=32&type=section&id=Funding%20Requirements) This section outlines expected increases in operating and capital expenditures and the company's liquidity outlook - Operating and capital expenditures are expected to increase due to expansion of the commercial team, NOP growth, scaling manufacturing, R&D, regulatory approvals, and greater control of air and ground transport[137](index=137&type=chunk) - The Company believes existing cash will fund operating expenses, capital expenditures, and debt service for at least **12 months** following the filing of this report[138](index=138&type=chunk) - Additional funding may be required, which might not be available on favorable terms or at all, potentially leading to delays or discontinuation of product development and commercialization efforts[138](index=138&type=chunk) [Material Contractual Obligations](index=33&type=section&id=Material%20Contractual%20Obligations) This section confirms no material changes to the company's cash requirements since the 2024 Form 10-K - There have been no material changes to the Company's cash requirements from those disclosed in its 2024 Form 10-K[139](index=139&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section confirms no material changes to critical accounting policies and estimates since the 2024 Form 10-K - No material changes have occurred to the Company's critical accounting policies and estimates from those disclosed in its 2024 Form 10-K[141](index=141&type=chunk) [Recently Issued Accounting Pronouncements](index=33&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section refers to Note 2 for details on recently issued accounting pronouncements and their potential impact - A description of recently issued accounting pronouncements that may impact financial position, results of operations, or cash flows is provided in Note 2 to the condensed consolidated financial statements[142](index=142&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to interest rate and foreign currency exchange rate risks - The Company is exposed to market risks from changes in interest rates (due to variable rate debt) and foreign currency exchange rates (due to transactions in various foreign currencies)[143](index=143&type=chunk) - These risks are managed through normal operating and financing activities[143](index=143&type=chunk) - There has been no material change in the foreign currency exchange risk or interest rate risk discussed in the 2024 Form 10-K[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluates disclosure controls, identifies a material weakness, outlines remediation, and confirms no other changes [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management concluded that the Company's disclosure controls and procedures were not effective as of March 31, 2025, due to a material weakness in internal control over financial reporting[147](index=147&type=chunk) - The identified material weakness relates to the lack of effective controls over inventory movement within the manufacturing network for interim financial statements[147](index=147&type=chunk) - Despite the material weakness, management concluded that the condensed consolidated financial statements fairly present the financial position, results of operations, and cash flows in all material respects[147](index=147&type=chunk) [Remediation Plan](index=34&type=section&id=Remediation%20Plan) - Management is assessing and finalizing a plan to remediate the material weakness by designing internal controls to ensure timely and accurate recording of inventory movements throughout the year[148](index=148&type=chunk) - Remediation will be considered complete only after the controls have been in place, operated for a sufficient period, and tested effectively[148](index=148&type=chunk) [Changes in Internal Control over Financial Reporting](index=34&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No changes in internal control over financial reporting occurred during the three months ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[149](index=149&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) Two class action lawsuits were filed in Q1 2025 alleging misstatements, anticompetitive conduct, and fraudulent billing - Two class action lawsuits, Jewik v. TransMedics Group, Inc., et al., and Collins v. TransMedics Group, Inc., et al., were filed in the United States District Court for the District of Massachusetts in Q1 2025[152](index=152&type=chunk)[153](index=153&type=chunk) - The complaints allege purported misstatements and omissions in risk disclosures, coercive business and marketing tactics, anticompetitive conduct, and fraudulent billing activities[152](index=152&type=chunk) - Motions seeking to consolidate the actions and appoint a lead plaintiff are currently pending[153](index=153&type=chunk) - The Company notes that such proceedings could adversely impact its reputation, business, and financial condition, and divert management attention[154](index=154&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the 2024 Form 10-K for a comprehensive discussion of investment risks - Investing in the Company's common stock involves a high degree of risk[155](index=155&type=chunk) - A detailed discussion of the risks affecting the business can be found in the 'Item 1A. Risk Factors' section of the Company's 2024 Form 10-K[155](index=155&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds occurred during the reporting period - No unregistered sales of equity securities or use of proceeds occurred during the fiscal quarter ended March 31, 2025[156](index=156&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the fiscal quarter ended March 31, 2025[157](index=157&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including certifications and XBRL documents - The exhibits include certifications from the Principal Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1, 32.2) and XBRL-related documents (101.INS, 101.SCH, 104)[158](index=158&type=chunk) [Signatures](index=37&type=section&id=Signatures) This section contains official signatures of principal executive and financial officers, certifying report accuracy - The report was duly signed on May 8, 2025, by Waleed H. Hassanein, M.D., President and Chief Executive Officer, and Gerardo Hernandez, Chief Financial Officer and Treasurer[162](index=162&type=chunk)[163](index=163&type=chunk)