Financial Performance - Net revenue for the three months ended September 30, 2020, was $7,091,000, a slight decrease of 1.6% compared to $7,205,000 for the same period in 2019[20]. - Gross profit for the nine months ended September 30, 2020, was $11,807,000, an increase of 17% from $10,122,000 in the same period of 2019[20]. - The net loss for the three months ended September 30, 2020, was $5,088,000, an improvement from a net loss of $8,280,000 in the same period of 2019, indicating a reduction of 38.5%[22]. - For the fiscal nine months ended September 30, 2020, the net loss was $22,437 thousand, compared to a net loss of $24,370 thousand for the same period in 2019, indicating a reduction in losses[31]. - The Company generated net revenue of $18.0 million and incurred a net loss of $22.4 million for the fiscal nine months ended September 30, 2020, compared to a net revenue of $23.6 million and a net loss of $33.5 million for the fiscal year ended December 28, 2019[123]. Assets and Liabilities - Total assets increased to $159,322,000 as of September 30, 2020, up from $105,299,000 on December 28, 2019, representing a growth of 51.3%[17]. - The company had total liabilities of $49,772,000 as of September 30, 2020, a slight decrease from $50,650,000 on December 28, 2019, indicating a reduction of 1.7%[17]. - Total stockholders' equity rose to $109,550,000 as of September 30, 2020, compared to $54,649,000 on December 28, 2019, marking an increase of 100%[17]. - As of September 30, 2020, the company had cash, cash equivalents, and marketable securities totaling $132.7 million, expected to fund operations for at least the next 12 months[39]. Revenue Sources - The Company’s revenue is primarily generated from sales of organ-specific disposable sets and OCS Consoles, with additional revenue from rentals[54]. - OCS Heart net revenue increased to $5.427 million for the fiscal three months ended September 30, 2020, compared to $3.739 million in the same period in 2019, reflecting a growth of approximately 45.2%[71]. - Net revenue from customers in the United States increased by $1.579 million to $5.920 million for the fiscal three months ended September 30, 2020, while revenue from outside the U.S. decreased by $1.693 million to $1.171 million[157]. Operating Expenses - Operating expenses totaled $9,648,000 for the three months ended September 30, 2020, down from $11,458,000 in the same period of 2019, reflecting a decrease of 15.8%[20]. - Total operating expenses for the fiscal nine months ended September 30, 2020, were $32.295 million, an increase of $1.264 million compared to $31.031 million in 2019[165]. - Selling, general, and administrative expenses increased by $0.6 million to $18.0 million for the nine months ended September 30, 2020, mainly due to higher personnel costs[173]. Research and Development - Research and development expenses for the nine months ended September 30, 2020, were $14,283,000, an increase of 4.9% from $13,608,000 in the same period of 2019[20]. - Total research, development, and clinical trials expenses rose by $0.7 million to $14.3 million for the nine months ended September 30, 2020, driven by increased personnel and clinical trial costs[172]. Impact of COVID-19 - The COVID-19 pandemic has negatively impacted OCS product sales since Q2 2020, with anticipated continued effects for the remainder of 2020[42]. - The impact of the COVID-19 pandemic has resulted in significant disruptions to the company’s operations, including delays in clinical trials and transplant procedures[128]. - Recovery in transplant procedures has been observed, but activity levels have not yet returned to pre-pandemic levels[131]. Financing and Capital Structure - Proceeds from the issuance of common stock in the public offering, net of underwriting discounts and commissions, amounted to $75,670 thousand, compared to $97,367 thousand in the previous year[31]. - The Company completed an underwritten public offering on May 26, 2020, resulting in net proceeds of approximately $75.0 million after deducting offering costs[126]. - The company has authorized up to 150 million shares of common stock, with no dividends declared or paid as of September 30, 2020[97]. Future Outlook - The company expects long-term net revenue growth driven by FDA approvals for OCS products and increased non-U.S. sales[141]. - The company expects costs and expenses to increase as it expands its sales and clinical adoption team, scales manufacturing operations, and continues research and development efforts[193]. - The company believes existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditures for at least 12 months following the filing of the Quarterly Report[195].
TransMedics(TMDX) - 2020 Q3 - Quarterly Report