TransMedics(US:TMDX)2025-10-29 20:23Financial Performance - Total revenue for the three and nine months ended September 30, 2025, was $143.8 million and $444.7 million, respectively, with net income of $24.3 million and $84.9 million[101]. - Net product revenue for the three months ended September 30, 2025, was $87.7 million, an increase of $21.8 million (33.1%) compared to $65.9 million in 2024[121]. - Total revenue for the three months ended September 30, 2025, reached $143.8 million, up $35.1 million (32.3%) from $108.8 million in 2024[121]. - Gross profit increased by $23.7 million (38.9%) to $84.6 million for the three months ended September 30, 2025, compared to $60.8 million in 2024[121]. - Net income for the three months ended September 30, 2025, was $24.3 million, a significant increase of $20.1 million (476.5%) compared to $4.2 million in 2024[121]. - For the nine months ended September 30, 2025, net income was $84.9 million, an increase of $56.3 million (197.3%) compared to $28.6 million in 2024[134]. - Total OCS transplant revenue for the nine months ended September 30, 2025, was $441.7 million, an increase of $125.0 million (39.4%) compared to $316.6 million for the same period in 2024[135]. - Gross profit increased by $79.3 million (approximately 25.0%) to $379.0 million for the nine months ended September 30, 2025, compared to $299.7 million in 2024[139]. - Overall gross margin improved to 61% for the nine months ended September 30, 2025, compared to 59% in the same period of 2024[140]. Expenses and Costs - Operating expenses for the three months ended September 30, 2025, totaled $61.3 million, an increase of $4.4 million (7.7%) from $56.9 million in 2024[121]. - Research, development, and clinical trials expenses are anticipated to rise as the company continues product development and regulatory approval efforts[116]. - Research, development, and clinical trials expenses increased by $1.0 million (7.0%) to $15.3 million for the three months ended September 30, 2025, compared to $14.3 million in 2024[128]. - Total research, development, and clinical trials expenses rose by $8.9 million (22.5%) to $48.4 million in 2025 from $39.5 million in 2024[141]. - Selling, general, and administrative expenses are expected to increase as the company expands its commercial team and infrastructure to support sales growth[117]. - Selling, general, and administrative expenses rose by $3.4 million (7.9%) to $46.0 million for the three months ended September 30, 2025, compared to $42.7 million in 2024[130]. - Selling, general, and administrative expenses increased by $12.0 million (9.9%) to $133.7 million for the nine months ended September 30, 2025, compared to $121.7 million in 2024[142]. Liquidity and Financing - The company has an accumulated deficit of $383.3 million as of September 30, 2025[101]. - The company has entered into a credit agreement borrowing $60.0 million and issued $460.0 million in aggregate principal amount of Notes to finance operations[118]. - Cash balance as of September 30, 2025, was $466.2 million, serving as the principal source of liquidity[145]. - Net cash provided by operating activities was $158.3 million for the nine months ended September 30, 2025, significantly up from $29.1 million in 2024[146]. - Interest expense decreased slightly to $10.4 million for the nine months ended September 30, 2025, from $10.8 million in 2024[143]. - The company issued $460.0 million in convertible senior notes on May 11, 2023, with a 1.5% interest rate and a maturity date of June 1, 2028[153]. - The company entered into a credit agreement with CIBC, borrowing $60.0 million, with amendments made on May 8, 2023, June 23, 2023, and November 9, 2023[158]. - The company is required to maintain a minimum liquidity amount of either the consolidated adjusted EBITDA loss for the trailing four months or $10.0 million, and total net revenue must be at least 75% of the revenue plan presented to CIBC[161]. - As of September 30, 2025, the company was in compliance with all financial covenants of the CIBC Credit Agreement[161]. - The company believes existing cash will fund operating expenses and capital requirements for at least 12 months following the filing of the Quarterly Report[163]. Growth and Expansion - The company expects operating and capital expenditures to increase as it focuses on growing commercial sales and expanding its transplant logistics capabilities[101]. - The company plans to construct a new manufacturing facility in Mirandola, Italy, to support the next generation OCS technology platform and enhance international supply capabilities[105]. - In July 2025, the company purchased land in Mirandola, Italy, for future research and development and manufacturing facilities[164]. Technology and Products - The OCS technology platform includes three FDA-approved products for heart, lung, and liver transplantations, representing a significant advancement in organ preservation[99]. - Service revenue from transplant logistics services increased following the acquisition of Summit Aviation, contributing $1.2 million and $3.1 million for the three and nine months ended September 30, 2025, respectively[108]. - Total OCS transplant revenue for the three months ended September 30, 2025, was $142.6 million, an increase of $35.1 million (32.6%) from $107.5 million in 2024[122]. - Revenue from OCS transplant in the United States was $429.8 million, up $124.6 million (40.0%) from $305.2 million in the prior year, driven by higher sales volumes of OCS Liver and OCS Heart disposable sets[137]. Risk Factors - The company is exposed to interest rate and foreign currency exchange rate risks due to variable rate debt instruments and transactions in various foreign currencies[168]. - The company expects costs and expenses to increase as it expands its commercial team, manufacturing, and regulatory approval efforts for new products[162].