T2 Biosystems(TTOO) - 2021 Q1 - Quarterly Report

PART I FINANCIAL INFORMATION Financial Statements (unaudited) Unaudited Q1 2021 financial statements reveal increased revenue, ongoing net losses, and a stockholders' deficit, raising substantial doubt about going concern Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | Total current assets | $44,587 | $53,584 | | Total assets | $70,052 | $79,078 | | Total current liabilities | $10,401 | $9,800 | | Total liabilities | $70,618 | $70,352 | | Total stockholders' (deficit) equity | ($566) | $8,726 | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :--- | :--- | :--- | | Total revenue | $6,956 | $2,545 | | Product revenue | $4,650 | $1,045 | | Contribution revenue | $2,306 | $1,500 | | Loss from operations | ($9,702) | ($13,561) | | Net loss | ($10,660) | ($14,949) | | Net loss per share | ($0.07) | ($0.22) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,708) | ($14,740) | | Net cash provided by (used in) investing activities | $2,553 | ($67) | | Net cash provided by financing activities | $53 | $40,097 | - Management has concluded that substantial doubt exists about the Company's ability to continue as a going concern for at least 12 months from the financial statement issuance date due to a history of net losses, cash outflows, and reliance on future funding not considered probable[29] - The company's T2SARS-CoV-2 Panel, a COVID-19 molecular diagnostic test, received Emergency Use Authorization (EUA) from the FDA in August 2020[20] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Q1 2021 performance, highlighting significant revenue growth driven by product sales, while reiterating substantial doubt about the company's ability to continue as a going concern Results of Operations (in thousands) | | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Total revenue | $6,956 | $2,545 | $4,411 | | Cost of product revenue | $5,790 | $4,671 | $1,119 | | Research and development | $4,665 | $4,780 | ($115) | | Selling, general and administrative | $6,203 | $6,655 | ($452) | | Loss from operations | ($9,702) | ($13,561) | $3,859 | | Net loss | ($10,660) | ($14,949) | $4,289 | - Product revenue increased by $3.6 million, primarily driven by $3.3 million in higher consumables sales from the T2SARS-CoV-2 Panel, which began selling in Q3 2020[173] - The company again states that conditions raise substantial doubt about its ability to continue as a going concern for one year, as its plans to raise sufficient funding or reduce expenditures are considered less than probable[149][193] - In March 2021, the company entered into a new Sales Agreement with Canaccord Genuity LLC for an 'at the market' offering to sell up to $75.0 million of common stock[184] - Net cash used in operating activities decreased to $8.7 million in Q1 2021 from $14.7 million in Q1 2020, primarily due to a lower net loss and favorable changes in working capital, including a significant increase in accounts payable[196][197] Quantitative and Qualitative Disclosures about Market Risk The company, as a smaller reporting company, is not required to provide the information requested under this item - As a smaller reporting company, T2 Biosystems is not required to provide quantitative and qualitative disclosures about market risk[211] Controls and Procedures Management, including CEO and CFO, affirmed the effectiveness of disclosure controls and procedures as of March 31, 2021, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2021[214] - There were no changes to the company's internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, its internal controls[215] PART II OTHER INFORMATION Legal Proceedings The company states that it is not currently involved in any legal proceedings that would have a material adverse effect on its financial condition or results of operations - There are currently no claims or legal actions that would have a material adverse effect on the company's results of operations or financial condition[218] Risk Factors This section refers to risk factors detailed in the Annual Report on Form 10-K, confirming no material changes to previously disclosed risks - There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2020[219] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the reporting period - The company reported 'None' for this item[220] Defaults Upon Senior Securities This item is not applicable to the company for the reporting period - The company reported this item as 'Not applicable.'[221] Mine Safety Disclosures This item is not applicable to the company - The company reported this item as 'Not applicable.'[222] Other Information The company reported no other information required to be disclosed under this item - The company reported 'None' for this item[223] Exhibits, Financial Statement Schedules This section lists exhibits filed with the Form 10-Q, including amendments to the BARDA contract and CRG Term Loan Agreement, plus required officer certifications - Key exhibits filed include an amendment to the BARDA contract, an amendment to the CRG Term Loan Agreement, and required CEO/CFO certifications[225]