GlobeNewswire Inc | Mar 4, 2021 04:05PM EST

March 04, 2021

LEXINGTON, Mass., March 04, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc.(NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced financial results for the fourth quarter and full year ended December 31, 2020.

Recent Highlights

-- Achieved 2020 revenue of $18.1 million, including product revenue of $11.7 million, representing growth of 118% and 119%, respectively, compared to the prior year period -- Achieved record quarterly revenue of $7.8 million, including product revenue of $5.8 million, representing growth of 154% and 273%, respectively, compared to the prior year period -- Sold 57 T2Dx Instruments in 2020, including 47 in the U.S., more than doubling the U.S. installed base -- Sold 21 T2Dx Instruments in the fourth quarter, including 19 in the U.S. -- Increased U.S. sepsis test utilization by 72%, resulting in a fourth quarter annualized run rate of approximately $86,000 per legacy sepsis instrument and achieved U.S. COVID test utilization growth resulting in a fourth quarter annualized run rate of approximately $265,000 per instrument sold in 2020 -- Determined the T2SARS-CoV-2Panel is capable of detecting SARS-CoV-2 virus variants including those identified in the United Kingdom, South Africa and Brazil, along with 99.99% of all currently identified variants based on sequence alignments and in silico analysis -- Appointed Aparna Ahuja, MD as Chief Medical Officer to drive clinical programs and raise Company visibility within the medical laboratory community

We made considerable progress across the business during 2020, including building strong demand for our products. Total product sales increased by 119%, including 284% in the U.S. market. We sold 57 new T2Dx Instruments, including 47 in the U.S., which more than doubled our U.S. instrument installed base, and increased sepsis test utilization in the U.S. by 72% compared to the prior year, stated John Sperzel, President and CEO of T2 Biosystems. Heading into 2021, we will continue to focus on three corporate priorities accelerating our commercialization, improving our operations, and advancing our product pipeline which we believe positions the company for sustained growth and long-term success.

Fourth Quarter 2020 Financial Results Total revenue for the fourth quarter of 2020 was $7.8 million, an increase of 154% compared to the prior year period. Product revenue for the fourth quarter of 2020 was $5.8 million, an increase of 273% compared to the prior year period, driven by increased test panel and instrument sales. Research and contribution revenue for the fourth quarter of 2020 was $2.0 million, an increase of 30% compared to the prior year period, driven by increased activity under the BARDA contract.

Operating expenses for the fourth quarter of 2020 were $8.7 million, a decrease of $3.2 million compared to the prior year period, driven by lower selling, general and administrative headcount and spending.

Net loss for the fourth quarter of 2020 was $9.9 million or a loss of $0.07 per share, compared to a net loss of $14.0 million, or a loss of $0.29 per share, in the prior year period.

Full Year 2020 Financial ResultsTotal revenue for 2020 was $18.1 million, an increase of 118%, compared to the prior year period. Product revenue for 2020 was $11.7 million, an increase of 119% compared to the prior year period. Research and contribution revenue for 2020 was $6.5 million, an increase of 115% compared to the prior year period.

Operating expenses for 2020 were $38.2 million, a decrease of $5.4 million compared to the prior year period driven primarily by lower selling, general and administrative headcount and spending.

Net loss for 2020 was $46.8 million, or a loss of $0.39 per share, compared to a net loss of $59.0 million, or a loss of $1.30 per share, in 2019.

Cash, equivalents, marketable securities and restricted cash were $52.7 million as of December 31, 2020.

2021 Financial OutlookThe Company expects full year 2021 total revenue to be between $24.0 million and $26.0 million, including product revenue between $16.0 million and $18.0 million and research and contribution revenue of $8.0 million. The Company expects to close at least 30 T2Dx Instrument contracts in 2021.

Webcast and Conference Call InformationT2s management team will host a conference call today, March 4, 2021, beginning at 4:30pm ET. Investors interested in listening to the call may do so by dialing 877-407-9208 for domestic callers or 1-201-493-6784 for International callers. A live and recorded webcast of the call will be available on the Investors section of the Companys website at www.t2biosystems.com.

AboutT2 BiosystemsT2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems products include the T2Dx Instrument, T2Candida Panel, the T2Bacteria Panel, the T2Resistance Panel, and the T2SARS-CoV-2 Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris Panel, and T2Lyme Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our revenue results and cash balance, financial outlook, anticipated strategic priorities, product demand, commitments or opportunities, and growth expectations or targets, 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. Furthermore, statements contained in this document relating to the recent global outbreak of the novel coronavirus disease(COVID-19),the impact of which remains inherently uncertain on our financial results, are forward-looking statements. These forward-looking statements are based on managements current expectations. 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 companys Annual Report on Form10-Kfor the year ended December31, 2019, filed with the U.S. Securities and Exchange Commission, or SEC, on March16, 2020, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Companys silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the companys views as of any date subsequent to the date of this press release.

Media Contact:Gina Kent,Vault Communicationsgkent@vaultcommunications.com610-455-2763

Investor Contact:Philip Trip Taylor, Gilmartin Groupphilip@gilmartinIR.com415-937-5406

T2 Biosystems,Inc.Consolidated Balance Sheets(Unaudited, in thousands, except share and per share data)

December December 31, 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 16,793 $ 11,033 Marketable securities 25,396 ? Accounts receivable 5,099 2,825 Inventories 3,636 3,599 Prepaid expenses and other current assets 2,660 1,438 Total current assets 53,584 18,895 Property and equipment, net 3,771 5,845 Operating lease right-of-use assets 11,034 3,360 Restricted cash 551 180 Marketable securities 10,002 ? Other assets 136 206 Total assets $ 79,078 $ 28,486 Liabilities and stockholders? (deficit) equity Current liabilities: Notes payable $ ? $ 42,902 Accounts payable 2,058 3,753 Accrued expenses and other current liabilities 7,512 11,207 Derivative liability ? 2,425 Deferred revenue 230 285 Total current liabilities 9,800 60,572 Notes payable, net of current portion 45,235 ? Operating lease liabilities, net of current portion 10,533 1,873 Deferred revenue, net of current portion 424 46 Derivative liability 1,010 ? Other liabilities 3,350 ? Commitments and contingencies (see Notes 13) Stockholders? (deficit) equity: Preferred stock, $0.001 par value; 10,000,000 ? ? shares authorized; no shares issued and outstandingCommon stock, $0.001 par value; 200,000,000 sharesauthorized; 148,078,974 and 50,651,535 shares 147 51 issued and outstanding at December 31, 2020 andDecember 31, 2019, respectivelyAdditional paid-in capital 431,545 342,121 Accumulated other comprehensive loss 9 ? Accumulated deficit (422,975 ) (376,177 )Total stockholders? (deficit) equity 8,726 (34,005 )Total liabilities and stockholders? (deficit) $ 79,078 $ 28,486 equity

T2 Biosystems,Inc.Consolidated Statements of Operations and Comprehensive Loss(Unaudited, in thousands, except share and per share data)

Year ended December 31, 2020 2019 Revenue: Product revenue $ 11,677 $ 5,327 Research revenue 11 563 Contribution revenue 6,442 2,445 Total revenue 18,130 8,335 Costs and expenses: Cost of product revenue 21,280 16,763 Research and development 16,919 16,326 Selling, general and administrative 21,287 27,304 Total costs and expenses 59,486 60,393 Loss from operations (41,356 ) (52,058 )Interest expense, net (5,504 ) (7,348 )Other income, net 62 400 Net loss and comprehensive loss (46,798 ) (59,006 )Net loss per share ? basic and diluted $ (0.39 ) $ (1.30 )Weighted-average number of common shares usedin computing net loss per share ? basic and 121,331,464 45,507,754 diluted

T2 Biosystems,Inc.Consolidated Statements of Operations and Comprehensive Loss(Unaudited, in thousands, except share and per share data)

Q4 2020 Q4 2019 Revenue: Product revenue $ 5,834 $ 1,562 Research revenue - 294 Contribution revenue 1,954 1,213 Total revenue 7,788 3,069 Costs and expenses: Cost of product revenue 7,476 3,611 Research and development 4,036 4,279 Selling, general and administrative 4,596 7,546 Total costs and expenses 16,108 15,436 Loss from operations (8,320 ) (12,367 )Interest expense, net (1,598 ) (1,690 )Other income, net 9 16 Net loss and comprehensive loss (9,909 ) (14,041 )Net loss per share ? basic and diluted $ (0.07 ) $ (0.29 )Weighted-average number of common shares usedin computing net loss per share ? basic and 148,018,044 47,870,662 diluted