Financial Performance - Net revenue for the three months ended June 30, 2020, was $3,391,000, a decrease of 40% compared to $5,666,000 for the same period in 2019[20]. - Gross profit for the six months ended June 30, 2020, was $6,769,000, an increase of 15% from $5,906,000 in the same period of 2019[20]. - The net loss for the three months ended June 30, 2020, was $8,497,000, compared to a net loss of $9,195,000 for the same period in 2019, indicating a 7.6% improvement[20]. - For the fiscal six months ended June 30, 2020, the company reported a net loss of $17.3 million, compared to a net loss of $16.1 million for the same period in 2019[33]. - The company reported total net revenue of $3.391 million for the fiscal three months ended June 30, 2020, compared to $5.666 million for the same period in 2019, reflecting a decrease of approximately 40%[74]. - For the fiscal six months ended June 30, 2020, total net revenue was $10.921 million, an increase of about 5.6% compared to $10.342 million for the same period in 2019[74]. Assets and Liabilities - Total assets increased to $163,137,000 as of June 30, 2020, up from $105,299,000 on December 28, 2019, representing a 55% growth[17]. - The company had total liabilities of $49,377,000 as of June 30, 2020, a slight decrease from $50,650,000 on December 28, 2019[17]. - Total stockholders' equity rose to $113,760,000 as of June 30, 2020, up from $54,649,000 at the end of 2019, representing a 108% increase[17]. - Cash and cash equivalents increased to $51,152,000 as of June 30, 2020, compared to $20,092,000 as of December 28, 2019, marking a 154% increase[17]. - As of June 30, 2020, the company had cash, cash equivalents, and marketable securities of $139.4 million[184]. Operating Expenses - Operating expenses totaled $9,770,000 for the three months ended June 30, 2020, down from $11,038,000 in the same period of 2019, reflecting an 11% reduction[20]. - The company incurred significant operating losses since inception, primarily funded by proceeds from sales of preferred stock and common stock[184]. - Total operating expenses for the fiscal six months ended June 30, 2020 increased by $3.1 million to $22.6 million, primarily due to increased research and development costs[171]. Research and Development - Research and development expenses for the six months ended June 30, 2020, were $10,128,000, an increase of 16% from $8,669,000 in the same period of 2019[20]. - Total research, development, and clinical trials expenses decreased by $0.9 million to $3.9 million for the fiscal three months ended June 30, 2020, despite a $0.8 million increase in personnel-related costs[165]. Impact of COVID-19 - OCS product sales were negatively impacted by the COVID-19 pandemic in the second quarter of 2020, with anticipated continued negative effects for the remainder of 2020[45]. - The COVID-19 pandemic has caused disruptions in transplant procedures and clinical trials, negatively impacting revenue and operational activities[44]. - The company has observed a recovery in the frequency of transplant procedures, although not yet at pre-COVID-19 levels, and anticipates ongoing demand for organ transplantations[136]. Financing Activities - The company completed an underwritten public offering of 5,750,000 shares of common stock on May 26, 2020, raising approximately $75.0 million in net proceeds after deducting costs[39]. - Net cash provided by financing activities was $75.7 million for the fiscal six months ended June 30, 2020, compared to $95.4 million for the same period in 2019[192]. Revenue Recognition - The Company recognizes revenue primarily from sales of organ-specific disposable sets and OCS Consoles, with all performance obligations typically satisfied at the same time[57][58]. - The Company recognized revenue for OCS Perfusion Sets and OCS Solutions at the point of title transfer, which typically occurs upon delivery to the customer site[64]. - The Company’s revenue recognition policy applies uniformly whether sales are made directly to end customers or through distributors[76]. Market and Competition - The Company operates in a rapidly changing environment with risks including technological innovations by competitors and regulatory compliance[42]. - The company expects long-term revenue growth from future FDA approvals for OCS Heart and OCS Liver products, as well as increased non-U.S. sales[146]. Stock and Equity - The company has authorized the issuance of up to 25,000,000 shares of preferred stock, all of which is undesignated as of June 30, 2020[100]. - The company granted options for the purchase of 564,836 shares of common stock during the six months ended June 30, 2020, with a weighted average grant fair value of $7.89 per share[105]. Legal and Compliance - The company is not currently subject to any material legal proceedings[214]. - The company is classified as an emerging growth company and has opted to take advantage of an extended transition period for new accounting standards[208].

TransMedics Group, Inc. (NASDAQ:TMDX) Q1 2020 Earnings Conference Call May 6, 2020 4:30 PM ET Company Participants Brian Johnston – Vice President, Investor Relations-Gilmartin Group Waleed Hassanein – President and Chief Executive Officer Stephen Gordon – Chief Financial Officer Conference Call Participants Robbie Marcus – JPMorgan Bryan Bergin – Cowen Suraj Kalia – Oppenheimer Operator Ladies and gentlemen, thank you for standing by, and welcome to the TransMedics Q1 2020 Earnings Conference Call. At this ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38891 TransMedics Group, Inc. (Exact name of registrant as specified in its charter) Massachusetts 83-2181531 ( ...

Regulatory Compliance - The company is subject to extensive regulation by the FDA and comparable authorities in the EU, impacting the development and commercialization of its products [141]. - The company must comply with stringent QSR requirements, including maintaining a device master record and undergoing periodic inspections by the FDA [155]. - Non-compliance with regulatory requirements could lead to sanctions such as product recalls, operating restrictions, or even criminal prosecution [158]. - The company is required to report serious adverse events and provide periodic safety reports under EU regulations, which will become stricter after May 26, 2020 [164]. - The Medical Devices Regulation (MDR) requires recertification of all medical devices by September 19, 2022, with increased evidence for safety and efficacy [162]. - The company’s notified body for CE marking is now based in the Netherlands following Brexit, as UK-issued certificates are no longer recognized [166]. - Compliance with international regulations varies significantly, affecting product registration, marketing, and safety reporting across different countries [168]. - The Anti-Kickback Statute prohibits certain financial interactions with healthcare providers, which could lead to severe penalties if violated [174]. - The company must adhere to evolving healthcare laws and regulations, which may result in significant financial penalties for non-compliance [176]. - The EU's post-market surveillance requirements emphasize active data gathering and analysis to ensure device safety and performance [163]. Financial Performance - The company has a backlog of $0.5 million as of December 28, 2019, down from $1.2 million in the previous year, with expectations to invoice substantially all within the next 12 months [136]. - The company completed its IPO on May 6, 2019, issuing 6,543,500 shares and netting proceeds of $91.4 million after costs [196]. - The company is classified as an "emerging growth company" and will retain this status until it meets certain revenue or market value thresholds [198]. - The Affordable Care Act imposed a 2.3% federal excise tax on medical devices, which was suspended from 2016 to 2019 and is set to be reinstated on January 1, 2020 [190]. - For the fiscal year ended December 28, 2019, 31% of net revenue and 29% of operating costs were generated by subsidiaries with functional currencies other than the U.S. dollar, exposing the company to foreign currency risk [472]. - The company recognized foreign currency transaction losses of $0.2 million during the fiscal year ended December 28, 2019 [470]. - The company recorded a foreign currency translation gain of less than $0.1 million during the fiscal year ended December 28, 2019 [471]. - As of December 28, 2019, the company had cash, cash equivalents, and marketable securities totaling $80.7 million [474]. - Borrowings under the Credit Agreement with OrbiMed totaled $35.0 million as of December 28, 2019, with an interest rate of 10.63% [475]. - An immediate 10% change in LIBOR would not have a material impact on the company's debt-related obligations or financial position [475]. - An immediate 10% change in interest rates would not materially affect the fair market value of the company's investment portfolio [474]. - The company does not believe that inflation has had a material effect on its business or financial condition [476]. - The company does not currently hedge its foreign currency risk [473]. Product Development and Clinical Trials - The company aims to expand clinical evidence for the OCS platform through trials and publications, improve technology and manufacturing efficiency, and develop the next generation OCS [137]. - The company received PMA approval for the OCS Lung in March 2018 and May 2019 for the preservation of donor lungs, with future plans for approvals for donor hearts and livers [145]. - The PMA process requires extensive data from preclinical studies and human clinical trials, with the FDA generally taking about one year for review [146]. - The company is currently conducting pivotal trials for the OCS Liver and OCS Heart under IDEs to investigate their safety and effectiveness [153]. - The company must complete three PMA post-approval studies for the OCS Lung, including the OCS Lung INSPIRE Continuation PAS and the TOP Registry [147]. Manufacturing and Capacity - The company has the capability to significantly increase manufacturing capacity with additional shifts at its facility in Andover, Massachusetts [136]. - The company relies on third parties for service provision, necessitating contractual arrangements to ensure compliance with data privacy laws [188]. Workforce and Employment - As of December 28, 2019, the company employed 109 people globally, primarily full-time employees [194]. Market Position and Relationships - The company has established clinical relationships and brand recognition among leading transplant programs worldwide, enhancing its market position [138]. Risk Factors - The company faces potential delays in obtaining foreign regulatory clearances, which may differ from FDA requirements [169]. - The company is exposed to changes in interest rates and foreign currency exchange rates due to variable rate debt instruments [469]. - The company must ensure compliance with local data protection authorities in jurisdictions where it operates [187]. - The company may face significant fines for non-compliance with GDPR, which includes stringent accountability obligations for data controllers [186]. - Future healthcare reforms in the U.S. could limit reimbursement for procedures associated with the company's products, impacting revenue [189].

Organ Care System (OCS") Redefining What's Possible in Organ Transplantation | --- | --- | |-------|-------| | | | | | | The OCS is the only technology platform addressing lung, heart and liver transplant therapy Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our results of operations, commercial opportunity and the rate of adoption ...

TransMedics Group, Inc. (NASDAQ:TMDX) Q4 2019 Earnings Conference Call March 2, 2020 4:30 PM ET Company Participants Brian Johnston - Managing Director, Gilmartin Group Waleed Hassanein - Founder, President and Chief Executive Officer Stephen Gordon - Chief Financial Officer Conference Call Participants Allen Gong - JPMorgan David Lewis - Morgan Stanley Jason Mills - Canaccord Genuity Group Inc. Operator Good day, ladies and gentlemen, and welcome to the TransMedics Fourth Quarter and Full-Year 2019 Earning ...

Organ Care System (OCS") Redefining What's Possible in Organ Transplantation | --- | --- | |--------------------------------------------------------------------------|-------| | | | | that is transforming organ transplantation to a more dynamic environment | | The OCS is the only technology platform addressing lung, heart and liver transplant therapy Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance ...

Transmedics Group, Inc. (NASDAQ:TMDX) Q2 2019 Earnings Conference Call August 7, 2019 4:30 PM ET Company Participants Gregory Chodaczek - Gilmartin Group Waleed Hassanein - Founder, CEO, President & Director Stephen Gordon - CFO. Treasurer & Secretary Conference Call Participants David Lewis - Morgan Stanley Christian Moore - JPMorgan Chase & Co. Joshua Jennings - Cowen and Company Jason Mills - Canaccord Genuity Corp. Operator Good afternoon, ladies and gentlemen, and welcome to the TransMedics Second Quar ...

Organ Care System (OCS") Redefining What's Possible in Organ Transplantation | --- | --- | |-------|-------| | | | | | | The OCS is the only technology platform addressing lung, heart and liver transplant therapy Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our results of operations, commercial opportunity and the rate of adoption ...

TransMedics, Inc. (NASDAQ:TMDX) Q1 2019 Results Conference Call June 11, 2019 4:30 PM ET Company Participants Greg Chodaczek - IR Waleed Hassanein - President and Chief Executive Officer Stephen Gordon - Chief Financial Officer Conference Call Participants David Lewis - Morgan Stanley Robbie Marcus - JP Morgan Josh Jennings - Cowen Operator Good day, ladies and gentlemen, and welcome to the TransMedics First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Lat ...