NEW YORK, March 3, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of TransMedics Group, Inc. (NASDAQ: TMDX).Shareholders who purchased shares of TMDX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/transmedics-group-inc-loss-submission-form-2/?id=132977&from=4 CLASS PERIOD: Febr ...

Core Viewpoint - A securities class action lawsuit has been filed against TransMedics Group, Inc. for alleged misconduct during the class period from February 28, 2023, to January 10, 2025, with a lead plaintiff deadline set for April 15, 2025 [1]. Allegations Against TransMedics - The complaint alleges that TransMedics engaged in unethical practices, including the use of kickbacks, fraudulent overbilling, and coercive tactics to generate business and revenue [3]. - It is claimed that TransMedics engaged in unsafe practices, concealed safety issues, and lacked proper safety oversight, which increased the company's regulatory risk [3]. Lead Plaintiff Process - Investors in TransMedics have until April 15, 2025, to seek appointment as a lead plaintiff representative, which involves directing the litigation on behalf of all class members [4]. - The lead plaintiff is typically the investor or small group of investors with the largest financial interest in the case [4].

Core Viewpoint - A class action lawsuit has been filed against TransMedics Group, Inc. for alleged violations of securities laws, claiming the company made false and misleading statements regarding its business practices and safety issues [1][4]. Group 1: Lawsuit Details - The lawsuit pertains to securities purchased between February 28, 2023, and January 10, 2025, and investors are encouraged to contact the Schall Law Firm before April 15, 2025, to participate [2]. - The complaint alleges that TransMedics generated revenue through kickbacks, overbilling, and coercive tactics, while concealing safety issues and engaging in unsafe practices [4]. Group 2: Investor Representation - The class in this case has not yet been certified, meaning that until certification occurs, investors are not represented by an attorney [3]. - Investors who suffered losses are invited to join the case to recover their damages [4]. Group 3: Law Firm Information - The Schall Law Firm specializes in securities class action lawsuits and represents investors globally [5]. - Contact information for the Schall Law Firm is provided for investors seeking to discuss their rights [6].

Core Insights - TransMedics Group, Inc. (TMDX) reported fourth-quarter 2024 earnings per share (EPS) of 19 cents, exceeding the Zacks Consensus Estimate of 18 cents by 5.6% and up from 12 cents in the same period last year [1] - The company achieved revenues of $121.6 million, reflecting a year-over-year increase of 49.8% and surpassing the Zacks Consensus Estimate by 10.2% [2] Financial Performance - For the full year 2024, TMDX recorded total sales of $441.5 million, an increase of 83% compared to 2023, with an EPS of $1.01 compared to a loss of 77 cents in 2023 [9] - Gross profit for the fourth quarter improved by 50.3% to $72 million, with a gross margin of 59.2%, slightly up from 59% in the fourth quarter of 2023 [10] - Operating income totaled $8.6 million, compared to $2.6 million in the year-ago period [12] Revenue Breakdown - Net product revenues, which include sales of OCS Perfusion Sets, OCS Solutions, and OCS Consoles, reached $74.9 million, up 44.5% year over year [5] - Service revenues, generated from logistics services supporting transplant programs, improved by 59.3% year over year to $46.7 million during the fourth quarter [8] Operational Highlights - TransMedics has three FDA-approved OCS products for heart, lung, and liver transplantations, representing the only FDA-approved portable, multi-organ, warm perfusion technology platform [4] - The company operates a National OCS Program, providing outsourced organ retrieval and management services, enhancing the efficiency of donor organ procurement [5][6] Market Reaction - Following the strong quarterly performance, TMDX shares rose by 6.9% in after-hours trading on February 27, although the shares have declined by 56.8% over the past six months [3] Future Guidance - For 2025, TransMedics expects revenues to be in the range of $530-$552 million, indicating a growth of 20-25% from 2024 levels, with the Zacks Consensus Estimate at $523.4 million [14]

TransMedics Group, Inc. (NASDAQ:TMDX) Q4 2024 Earnings Conference Call February 27, 2025 4:30 PM ET Company Participants Laine Morgan - Gilmartin Group, Investor Relations Waleed Hassanein - President and Chief Executive Officer Gerardo Hernandez - Chief Financial Officer Conference Call Participants Allen Gong - JPMorgan Josh Jennings - TD Cowen Bill Plovanic - Canaccord Suraj Kalia - Oppenheimer Chris Pasquale - Nephron Research Matthew O'Brien - Piper Sandler David Rescott - Baird Mike Matson - Needham & ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $121.6 million, representing approximately 50% growth year-over-year and 12% sequential growth from Q3 2024 [17][40] - Full year 2024 total revenue reached $441.5 million, representing approximately 83% growth over full year 2023 [19][49] - Overall gross margin for Q4 improved to 59%, up from 56% in Q3 2024 [18] - Operating profit for Q4 was $8.6 million, representing approximately 7.1% of total revenue, up from $3.9 million or 4% of total revenue in Q3 2024 [18][47] - Full year gross margin was 59.4%, down from 63.8% in 2023 due to a higher contribution of service revenue [20][52] Business Line Data and Key Metrics Changes - TransMedics transplant logistics service revenue for Q4 was $21.7 million, up from $9.2 million in Q4 2023 and up from $20.1 million in Q3 2024, representing approximately 8% sequential growth [18][40] - Product revenue for Q4 increased to $74.9 million, reflecting a 44.5% year-over-year growth [40] - Service revenue reached $46.7 million, growing 59.3% year-over-year [41] Market Data and Key Metrics Changes - U.S. revenue grew 11% sequentially to $117 million, while OUS revenue grew approximately 51% sequentially to $4 million [17] - For the full year 2024, U.S. revenue grew to $422 million, representing approximately 91% growth over the full year 2023 [19] - Overall U.S. liver transplant volume grew 9% over 2023 to 10,393 [23] Company Strategy and Development Direction - The company aims to expand the utilization of available donor organs for transplantation while delivering the best possible clinical outcomes [8] - Future growth will be driven by the launch of next-gen heart and lung clinical programs targeted for H2 2025 [27][33] - The company plans to strategically invest in business infrastructure to ensure scalability while maintaining quality and reducing supply chain risks [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2025, expecting revenue guidance between $530 million and $552 million, representing a 20% to 25% growth over 2024 [36][55] - Management acknowledged operational challenges, including unexpected aircraft maintenance impacting availability and variability in organ transplantation volume [35] - The company remains committed to its mission of expanding access and improving clinical outcomes for patients in need of organ transplants [60] Other Important Information - The company conducted an independent investigation regarding allegations raised in a short report, which found no evidence of fraud or misconduct [10][12] - The company reported a significant step towards sustained financial strength with positive cash flow from operating activities for the first time in 2024, generating $48.8 million compared to a $13 million outflow in 2023 [48][53] Q&A Session Summary Question: How should we think about the quarter-to-quarter cadence implied in your guide? - Management does not issue quarter-to-quarter guidance but acknowledges variability in the transplant market, particularly in Q3 and Q4 due to seasonal factors [64][65] Question: Should we assume liver will continue to drive the majority of growth? - Management believes liver will continue to lead growth until contributions from heart and lung clinical programs become significant [68] Question: What is the confidence level regarding high-volume customers in 2025? - Management has not seen any attrition among high-volume customers and remains confident in their customer base [72] Question: How does the New York Times article on organ allocation impact the business? - Management does not foresee a meaningful impact on business from the article and emphasizes the need for public education on organ transplant challenges [83] Question: What are the expectations for R&D spending growth in 2025? - Management expects to continue strong investment in R&D while achieving modest gains in operating leverage [117]

Core Insights - TransMedics reported a revenue of $121.62 million for the quarter ended December 2024, marking a 49.8% increase year-over-year, and an EPS of $0.19 compared to $0.12 in the same quarter last year [1] - The revenue exceeded the Zacks Consensus Estimate of $110.38 million by 10.19%, and the EPS also surpassed the consensus estimate of $0.18 by 5.56% [1] Revenue Breakdown - Geographic Revenues from the United States reached $116.65 million, exceeding the average estimate of $108.16 million, representing a year-over-year increase of 55.1% [4] - Geographic Revenues from all other countries totaled $3.89 million, surpassing the estimated $3 million, reflecting a 10.7% increase year-over-year [4] - OCS Liver net revenue was reported at $88.98 million, significantly above the average estimate of $76.93 million, indicating a year-over-year growth of 64.3% [4] - OCS Heart net revenue was $28.14 million, slightly below the estimated $28.81 million, but still showing a 35.2% increase compared to the previous year [4] - OCS Lung net revenue was $3.42 million, which is below the average estimate of $3.83 million, but represents a 6.8% increase year-over-year [4] Stock Performance - TransMedics shares have returned +12.6% over the past month, contrasting with a -2.2% change 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]

分组1 - TransMedics reported quarterly earnings of $0.19 per share, exceeding the Zacks Consensus Estimate of $0.18 per share, and up from $0.12 per share a year ago, representing an earnings surprise of 5.56% [1] - The company achieved revenues of $121.62 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 10.19%, compared to $81.17 million in the same quarter last year [2] - TransMedics has outperformed the S&P 500, with shares increasing about 18.3% since the beginning of the year, while the S&P 500 gained 1.3% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is $0.29 on revenues of $120.59 million, and for the current fiscal year, it is $1.43 on revenues of $523.37 million [7] - The Medical - Instruments industry, to which TransMedics belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook [8]

Core Insights - TransMedics Group significantly exceeded Wall Street's estimates in Q4 2024, reporting diluted EPS of $0.19 and revenue of $121.6 million, surpassing analyst forecasts of $0.16 and $109 million respectively [1][2] Financial Performance - Q4 2024 diluted EPS was $0.19, a 58.3% increase from $0.12 in Q4 2023 [2] - Revenue for Q4 2024 reached $121.6 million, reflecting a 49.8% year-over-year growth from $81.2 million in Q4 2023 [2] - Gross margin improved slightly to 59.2% from 59.0% [2] - Net income for the quarter was $6.9 million, up 70.1% from $4.0 million in Q4 2023 [2][6] Business Overview - TransMedics specializes in organ transplantation technology, particularly through its Organ Care System (OCS), which enhances organ preservation compared to traditional methods [3] - The National OCS Program supports the company's technology by improving the organ retrieval process [3] Strategic Focus - The company is concentrating on expanding its logistical capabilities and increasing the number of procedures facilitated by the OCS [4] - Key success factors include growing market share in the U.S. and obtaining FDA approvals for wider adoption and reimbursement arrangements [4] Market Growth - Revenue growth in Q4 was driven by increased adoption of the OCS in heart, lung, and liver transplants, alongside growth in logistics service revenue [5] - The number of U.S. OCS uses surged by 58% in 2024, increasing the company's market share in the transplant space to 20.9% from 13.8% in 2023 [5] Operational Developments - Operating expenses rose to $63.4 million from $45.3 million due to increased investments in research and development [6] - As of the end of the quarter, the company owned 19 aircraft to support organ transportation [7] Future Outlook - For 2025, TransMedics anticipates revenue growth of 20% to 25%, projecting revenues between $530 million and $552 million [8] - Management aims to enhance logistics and technological offerings to capture more market share and improve efficiencies [8]

Financial Performance - The company generated a net income of $35.5 million for the year ended December 31, 2024, but has an accumulated deficit of $468.2 million[159]. - A significant portion of revenue is generated from a limited number of customers, and any loss or reduction in demand from these customers could materially affect financial results[187]. - The company recognized foreign currency transaction losses of $0.7 million during the year ended December 31, 2024[428]. - A foreign currency translation loss of $0.2 million was recorded during the year ended December 31, 2024[429]. - For the year ended December 31, 2024, 3% of the company's revenue and 2% of operating costs were generated by subsidiaries with functional currencies other than the U.S. dollar[430]. Operating Challenges - The company expects operating and capital expenditures to continue increasing as it focuses on growing commercial sales and expanding its product offerings[160]. - The company may face challenges in recruiting and retaining qualified personnel necessary for its operations, impacting its ability to expand its organ procurement services[166]. - The company faces challenges in maintaining adequate inventory levels to meet customer demand, which could impact operations and reputation[176]. - The company may face challenges in obtaining flight services for its NOP, potentially leading to increased costs and limited capacity due to the number of available aircraft and pilots[193]. - The company must continue to demonstrate the clinical benefits of the OCS to encourage adoption among surgeons and payors[180]. Regulatory and Compliance Risks - Regulatory compliance is critical, as failure to meet FDA requirements could lead to enforcement actions, including recalls and withdrawal of product approvals[259]. - The company is subject to federal, state, and foreign fraud and abuse laws, which could result in substantial penalties if violated[300]. - Compliance with FDA's Quality System Regulation (QSR) is mandatory, and failure to comply could result in enforcement actions that harm business operations[283]. - The company must navigate complex foreign regulatory requirements, which can be time-consuming and expensive, affecting international sales[285]. - The company faces risks related to data privacy laws, including GDPR, which impose stringent requirements and could lead to significant fines for non-compliance[308]. Product Development and Market Risks - The company’s ability to maintain profitability is uncertain due to significant operating losses in recent years and reliance on customer utilization of its services[159]. - The company’s long-term growth depends on successfully developing the next generation of its products and expanding into new indications[170]. - The clinical trial process for regulatory approvals is lengthy and expensive, with uncertain outcomes that could delay product commercialization[198]. - The company has received PMA approvals from the FDA for three OCS products, but future commercialization success is uncertain[179]. - The company may face significant delays or failures in obtaining necessary regulatory approvals for modified products, impacting market introduction[281]. Financial Position and Funding - The company may need to raise additional funding, which could lead to shareholder dilution and may not be available on favorable terms[164]. - As of December 31, 2024, the company had cash of $336.7 million, with interest income sensitive to changes in interest rates[432]. - Borrowings under the CIBC Credit Agreement totaled $60.0 million as of December 31, 2024, with an interest rate of 6.4%[434]. - In May 2023, the company issued Notes with an aggregate principal amount of $460.0 million, with a fixed annual interest rate of 1.50%[435]. Supply Chain and Operational Risks - The company relies on third-party vendors for sterilization of its products, and any disruption in these services could harm its business operations[174]. - The company relies on single-source suppliers for many components used in the OCS, which poses risks if these suppliers cannot meet demand[189]. - The company depends on third parties for transportation of donor organs, and any limitations in this area could hinder growth and operations[192]. - Supply chain disruptions and inflation may lead to increased costs for raw materials, impacting operating results and margins[195]. - The company faces competition from a range of medical device and pharmaceutical companies that could limit demand for organ transplantation and its OCS products[196]. Intellectual Property and Legal Risks - The company is exposed to risks related to intellectual property, including potential infringement claims that could adversely affect its competitive position[239]. - The company may face claims regarding the misappropriation of third-party intellectual property, which could lead to costly litigation and operational disruptions[256]. - The company relies on trade secret protection and non-disclosure agreements to safeguard its proprietary information, but these measures may not be sufficient against misappropriation[255]. - The company may encounter significant challenges in protecting its proprietary rights in foreign countries compared to the United States[249]. - The company may face significant harm if it is unable to obtain patent term extensions under the Hatch-Waxman Act, which allows for a maximum of five years of patent restoration for approved products[252]. Aviation and Operational Risks - The operation of aircraft involves unique risks, including safety concerns that could impact customer retention and revenue[206]. - Reliance on a single aircraft manufacturer poses risks related to parts availability and service disruptions, potentially affecting operations[208]. - The FAA's oversight could lead to operational restrictions if mechanical problems or safety issues arise, impacting business continuity[210]. - The company faces a limited availability of qualified pilots, which may negatively impact operations and financial condition due to increased labor costs and stringent FAA qualification standards[211]. - Significant increases in aviation fuel costs could materially affect the company's operating expenses and overall financial condition[216]. Market and Competitive Environment - New technologies developed by competitors could render the OCS obsolete, affecting demand and market position[197]. - There is significant pricing pressure on the company's products, which could adversely affect gross margins and the ability to invest in business growth[194]. - Future healthcare policies may limit coverage or reimbursement for the company's products, impacting demand and pricing pressure[312]. - Legislative changes in the U.S. healthcare system could adversely affect the company's business, financial condition, and results of operations[311]. - The company’s revenue and profitability heavily depend on adequate reimbursement from Medicare and other payors for OCS purchases and transplant procedures[273]. Management and Governance - The company emphasizes the importance of retaining key personnel, including the CEO, for achieving research and commercialization objectives[236]. - Effective management of growth is crucial, necessitating enhancements in manufacturing, IT infrastructure, and financial systems[238]. - The company has adopted anti-takeover provisions that may frustrate attempts to change control or management[318]. - Investigations into the company's practices could divert management's attention and resources, potentially harming business operations[303]. - The company has implemented compliance policies to mitigate risks associated with anti-corruption and export control laws, but cannot guarantee complete protection[306].