EX-99.1 2 d865709dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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T2 Biosystems Announces Fourth Quarter and Full Year 2019 Financial Results

LEXINGTON, Mass., February 24, 2020 (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, 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.


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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 Results

Total 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 Outlook

Management 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 Information

T2’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


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T2 Biosystems, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 

     December 31,
2019
    December 31,
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  
  

 

 

   

 

 

 


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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