| Item 2.02 | Results of Operations and Financial Condition. |
On January 11, 2022, T2 Biosystems, Inc. (the “Company”) issued a press release announcing preliminary estimated financial results for its fiscal quarter and full year ended December 31, 2021. A copy of the Company’s press release is furnished with this report as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 of this Current Report on Form 8-K is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Furthermore, such information, including Exhibit 99.1 attached hereto, shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), except as expressly stated by specific reference in such a filing.
On January 11, 2022, the Company reported the following preliminary unaudited fourth quarter and full year 2021 financial and operational results:
| | • | | Achieved full year 2021 total revenue of $27.7 million, including product revenue of $16.7 million, representing an increase of 53% and 43%, respectively, compared to the prior year. |
| | • | | Achieved fourth quarter total revenue of $6.6 million, including fourth quarter product revenue of $4.0 million. |
| | • | | Executed contracts for 32 T2Dx® Instruments in 2021, including 17 T2Dx Instrument contracts during the fourth quarter, consisting of 3 from the U.S. and 14 from outside the U.S. |
| | • | | Generated fourth quarter U.S. sepsis test panel revenue of $5.1 million, representing growth of 46% compared to the prior year period. |
| | • | | Hired a veteran Chief Commercial Officer and significantly expanded the Company’s sales, marketing, clinical and medical affairs teams. |
| | • | | Initiated clinical trials for the T2Resistance® Panel and T2Biothtreat® Panel in December, enabling potential filing of FDA submissions for both products during 2022. |
| | • | | Expanded commercialization in the Asia Pacific and Latin America regions by entering into distributor agreements in Taiwan, Singapore, South Korea and Mexico. |
| | • | | Cash, cash equivalents, marketable securities and restricted cash totaled $33.7 million as of December 31, 2021. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the T2Biothreat Panel’s results, the T2Resistance Panel’s results, the Company’s plans to file FDA submissions, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. The preliminary, estimated financial results for the fourth quarter and fiscal year 2021 contained in this Current Report on Form 8-K contain forward-looking statements and are subject to the completion of management’s and the audit committee’s final reviews and our other financial closing procedures and are therefore subject to change. You should not place undue reliance on such preliminary information and estimates because they may prove to be materially inaccurate. The preliminary information and estimates have not been compiled or examined by our
