T2 BIOSYSTEMS, INC. Item 2.02 Results of Operations and Financial Condition.
On
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.
Item 8.01 Other Events.
On
• 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
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independent auditors and they are subject to revision as we prepare our
financial statements as of and for the quarter and fiscal year ended
These statements are neither promises nor guarantees, but involve known and
unknown risks, uncertainties and other important factors that may cause actual
results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking
statements, including, but not limited to, (i) any inability to (a) realize
anticipated benefits from commitments, contracts or products; (b) successfully
execute strategic priorities; (c) bring products to market; (d) expand product
usage or adoption; (e) obtain customer testimonials; (f) accurately predict
growth assumptions; (g) realize anticipated revenues; (h) incur expected levels
of operating expenses; or (i) increase the number of high-risk patients at
customer facilities; (ii) failure of early data to predict eventual outcomes;
(iii) failure to make or obtain anticipated FDA filings or clearances within
expected time frames or at all; or (iv) the factors discussed under Item 1A.
"Risk Factors" in the company's Annual Report on Form 10-K for the year ended
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press release issuedJanuary 11, 2022 announcing preliminary estimated financial results for the fourth quarter and full year endedDecember 31, 2021
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