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 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 T2Resistance 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.
Gina Kent, Vault Communications
Philip Trip Taylor, Gilmartin Group
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