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, 2019.

Fourth Quarter and Recent Business and Financial Performance Highlights

  • Achieved fourth quarter total revenue of $3.1 million and product revenue of $1.6 million, representing increases of 71% and 18% respectively, compared to the prior year period
  • Received CE mark for the T2Resistance Panel, allowing commercialization throughout the European Union and other CE mark geographies
  • Secured new contracts for ten T2Dx Instruments during the fourth quarter of 2019
  • Appointed John Sperzel as Chief Executive Officer and Tony Pare as Chief Commercial Officer

Full Year 2019 Business and Financial Performance Highlights

  • Awarded a contract for up to $69 million in milestone-based product development funding from a U.S. government agency; one of the largest grants ever awarded to a diagnostics company
  • Received a New Technology Add-on Payment (NTAP) for the T2Bacteria Panel from the Centers for Medicare and Medicaid Services (CMS); the first in-vitro diagnostic test with this designation
  • Received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for T2Resistance Panel, which is now available for research use only (RUO) in the U.S. market
  • Signed Breakthrough Technology contract with Premier, Inc., a group purchasing organization, providing access and contracted pricing to approximately 4,000 U.S. hospitals
  • Restructured the CRG Term Loan Agreement, extending the interest-only payment period through December 2021 and reducing minimum revenue targets
  • Expanded commercial distribution to include thirty-six countries

“The T2 Biosystems team achieved a number of important clinical and operational milestones in 2019,” said John Sperzel, President and CEO of T2 Biosystems. “According to recent data, sepsis is responsible for the death of nearly 11 million people annually, more than all cancers combined. In the battle against sepsis, speed is critical to achieving targeted therapy. T2 Biosystems has the only FDA cleared system for detecting sepsis-causing pathogens directly from blood, without the need to wait days for a positive culture. I believe we have an opportunity to save lives by becoming the standard of care in the detection of sepsis-causing pathogens, and drive long-term sustained growth.”

Fourth Quarter 2019 Financial Results Total revenue for the fourth quarter of 2019 was $3.1 million, an increase of 71% compared to the prior year period. Product revenue for the fourth quarter of 2019 was $1.6 million, an increase of 18% compared to the prior year period. Research revenue for the fourth quarter of 2019 was $1.5 million, an increase of 200% compared to the prior year period.

Operating expenses for the fourth quarter of 2019 were $11.9 million, an increase of $2.2 million compared to the prior year period.

Net loss for the fourth quarter of 2019 was $14.1 million or a loss of $0.30 per share, compared to a net loss of $15.1 million or a loss of $0.34 per share in the prior year period.

Full Year 2019 Financial ResultsTotal revenue for 2019 was $8.3 million, a decrease of 21%, compared to the prior year period. Product revenue for 2019 was $5.3 million, an increase of 11% compared to the prior year period. Research revenue for 2019 was $3.0 million, a decrease of 47% compared to the prior year period.

Operating expenses for 2019 were $43.6 million, an increase of 8% compared to the prior year period.

Net loss for 2019 was $59.0 million or a loss of $1.30 per share, compared to a net loss of $51.2 million or a loss of $1.26 per share in 2018.

Cash and equivalents as of December 31, 2019 were $11.0 million. This includes $4.8 million in net proceeds from the sale of 3.8 million shares through the ATM facility during the fourth quarter of 2019.

2020 Financial OutlookManagement projects revenue for the full year 2020 to range from $14.0 million to $17.0 million, including product revenue between $8.0 million and $10.0 million and research and grant contribution revenue of $6.0 million to $7.0 million. Management expects to close approximately 30 T2Dx Instrument contracts during 2020.   

Webcast and Conference Call InformationT2’s management team will host a conference call today, February 24, 2020, beginning at 4:30pm ET. Investors interested in listening to the call may do so by dialing 1-877-407-9208 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 Company’s website at www.t2biosystems.com.  

About T2 Biosystems T2 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, and the T2ResistanceTM Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease. 

Media Contact: Gina Kent, Vault Communications gkent@vaultcommunications.com   610-455-2763

Investor Contact: Philip Trip Taylor, Gilmartin Group philip@gilmartinIR.com 415-937-5406

       
T2 Biosystems, Inc.Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited)
       
  December 31,  December 31, 
  2019  2018 
Assets        
Current assets:        
Cash and cash equivalents $11,033  $50,805 
Accounts receivable  2,825   1,786 
Prepaid expenses and other current assets  1,438   1,340 
Inventories  3,599   2,677 
Total current assets  18,895   56,608 
Property and equipment, net  5,845   7,315 
Operating lease right-of-use assets  3,360    
Restricted cash  180   180 
Other assets  206   206 
Total assets $28,486  $64,309 
Liabilities and stockholders’ equity        
Current liabilities:        
Notes payable $42,902  $42,373 
Accounts payable  3,753   744 
Accrued expenses and other current liabilities  11,207   6,073 
Derivative liability  2,425   2,142 
Deferred revenue  285   697 
Current portion of lease incentives     268 
Total current liabilities  60,572   52,297 
Lease incentives, net of current portion     492 
Operating lease liabilities, net of current portion  1,873    
Deferred revenue, net of current portion  46   133 
Commitments and contingencies        
Stockholders’ equity:        
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding      
Common stock, $0.001 par value; 200,000,000 shares authorized; 50,651,535 and 44,175,441 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively  49   44 
Additional paid-in capital  342,123   328,514 
Accumulated deficit  (376,177)  (317,171)
Total stockholders’ equity  (34,005)  11,387 
Total liabilities and stockholders’ equity $28,486  $64,309 

    
T2 Biosystems, Inc.Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited)
    
  Year ended 
  December 31, 
  2019  2018  2017 
Revenue:            
Product revenue $5,327  $4,805  $3,440 
Research revenue  563   5,695   1,226 
Contribution revenue  2,445       
Total revenue  8,335   10,500   4,666 
Costs and expenses:            
Cost of product revenue  16,763   15,404   12,028 
Research and development  16,326   14,489   23,733 
Selling, general and administrative  27,304   25,697   22,757 
Total costs and expenses  60,393   55,590   58,518 
Loss from operations  (52,058)  (45,090)  (53,852)
Interest expense, net  (7,348)  (6,682)  (8,907)
Other income, net  400   619   331 
Net loss and comprehensive loss  (59,006)  (51,153)  (62,428)
Net loss per share — basic and diluted $(1.30) $(1.26) $(1.94)
Weighted-average number of common shares used in computing net loss per share — basic and diluted  45,507,754   40,558,826   32,131,512 

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