T2 Biosystems Reports Third Quarter 2017 Financial Results and Provides Company Update
Submitted 510(k) Application to the FDA Requesting Market Clearance for
Year over Year Quarterly Product Revenue Growth of 27.4%
Third Quarter Business and Financial Performance Highlights:
- Reported third quarter total revenue of
$1.1 million , in line with guidance. Product revenue of$739,000 , was a$159,000 or 27.4% increase from the third quarter of 2016. - Submitted 510(k) application to the
FDA requesting market clearance for T2Bacteria® Panel; continue to plan forFDA clearance as early as year-end. - Secured contracts with seven new hospitals internationally primarily for initial implementation of the T2Candida® Panel and three hospitals in the US for the
T2Bacteria Research Use Only Panel , that could provide access to an estimated 58,000 additional patients annually considered to be at high risk for sepsis infections. - Featured in seven sessions at IDWeek 2017 highlighting the positive impact of T2Candida and potential impact of T2Bacteria, including a session highlighting the potential benefits of the
T2Bacteria Panel within the emergency department. Henry Ford Health System published a study in theJournal of Antimicrobial Stewardship assessing the benefit and value of the rapid diagnostic result obtained with theT2Candida Panel .- Announced a partnership with the
Centers for Disease Control and Prevention (CDC) describing a new effort to use the T2Dx® Instrument and the Candida aurisInvestigational Use Only Panel to rapidly detect the superbug Candida auris. - Commenced a partnership with the biotechnology company
Cidara Therapeutics to use the T2Dx Instrument along with theT2Candida Panel as a means of accelerating patient enrollment in their Phase 3 clinical trial evaluating its lead antifungal compound. - Closed equity financing raising
$20.1 million in gross proceeds to fund continued research and development ofT2 Biosystems pipeline and commercialization of the T2Sepsis SolutionTM.
“Our operating progress in the third quarter was one of the best we have had,” said
Third Quarter Financial Results:
Total revenue for the third quarter of
Operating expenses, excluding cost of product revenue, in the third quarter decreased sequentially from the second quarter of 2017 by
Net loss attributable to common shareholders for the third quarter of 2017 was
Cash and cash equivalents as of
Outlook for Remainder of 2017:
The company is updating guidance for 2017, as follows:
- The company reaffirms expectations regarding the timeframe for
FDA clearance of theT2Bacteria Panel and continues to prepare for the commercial launch of theT2Bacteria Panel in the U.S. as early as year-end, pending market clearance by theFDA . - Total revenue in the fourth quarter is expected to be in the range of
$1.1 million to $1.3 million . Fourth quarter 2017 product revenue is expected to be in the range of$1.0 million to $1.2 million which would be a growth rate of 36% to 63% over the third quarter of 2017. Research revenue is expected to be in the range of$100,000 in the fourth quarter. - The target for increasing the number of high-risk patients at customer facilities under contract in the fourth quarter is 35,000 high risk patients, including additional contracts in
the United States for the use of theT2Bacteria Research Use Only Panel . - Operating expenses, excluding cost of product revenue, for the fourth quarter are projected to be in the range of
$11.4 million to $11.8 million .
Conference Call
Management will host a conference call today with the investment community at
About T2 Biosystems
Forward-Looking Statements
This 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 additional patients, timing of testing patients, anticipated product benefits, strategic priorities, product expansion or opportunities, growth expectations or targets, timing of
T2 BIOSYSTEMS, INC. | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue: | ||||||||||||||||
Product revenue | $ | 739 | $ | 580 | $ | 2,105 | $ | 1,168 | ||||||||
Research revenue | 369 | 504 | 900 | 2,003 | ||||||||||||
Total revenue | 1,108 | 1,084 | 3,005 | 3,171 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenue | 2,106 | 1,894 | 5,722 | 4,701 | ||||||||||||
Research and development | 5,880 | 5,200 | 19,577 | 18,160 | ||||||||||||
Selling, general and administrative | 5,559 | 5,935 | 17,192 | 18,282 | ||||||||||||
Total costs and expenses | 13,545 | 13,029 | 42,491 | 41,143 | ||||||||||||
Loss from operations | (12,437 | ) | (11,945 | ) | (39,486 | ) | (37,972 | ) | ||||||||
Interest expense, net | (1,718 | ) | (876 | ) | (5,008 | ) | (2,416 | ) | ||||||||
Other income, net | 79 | 38 | 260 | 133 | ||||||||||||
Net loss and comprehensive loss | $ | (14,076 | ) | $ | (12,783 | ) | $ | (44,234 | ) | $ | (40,255 | ) | ||||
Net loss per share — basic and diluted | $ | (0.45 | ) | $ | (0.51 | ) | $ | (1.43 | ) | $ | (1.64 | ) | ||||
Weighted-average number of common shares used in computing net loss per share — basic and diluted | 31,420,726 | 25,027,751 | 30,873,930 | 24,524,508 |
T2 BIOSYSTEMS, INC. | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
(In thousands, except share and per share data) | |||||||||
(Unaudited) | |||||||||
September 30, 2017 | December 31, 2016 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 52,897 | $ | 73,488 | |||||
Accounts receivable | 442 | 327 | |||||||
Prepaid expenses and other current assets | 754 | 820 | |||||||
Inventories, net | 1,254 | 803 | |||||||
Total current assets | 55,347 | 75,438 | |||||||
Property and equipment, net | 13,854 | 13,589 | |||||||
Restricted cash | 260 | 260 | |||||||
Other assets | 218 | 281 | |||||||
Total assets | $ | 69,679 | $ | 89,568 | |||||
Liabilities and stockholders’ equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 993 | $ | 962 | |||||
Accrued expenses and other current liabilities | 5,513 | 4,908 | |||||||
Current portion of notes payable | 1,416 | 1,269 | |||||||
Deferred revenue | 2,076 | 2,445 | |||||||
Current portion of lease incentives | 247 | 301 | |||||||
Total current liabilities | 10,245 | 9,885 | |||||||
Notes payable, net of current portion | 40,089 | 39,504 | |||||||
Lease incentives, net of current portion | 751 | 792 | |||||||
Other liabilities | 467 | 49 | |||||||
Stockholders’ equity: | |||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2017 and December 31, 2016 | — | — | |||||||
Common stock, $0.001 par value; 200,000,000 shares authorized; 35,796,322 and 30,482,712 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 36 | 30 | |||||||
Additional paid-in capital | 266,014 | 242,997 | |||||||
Accumulated deficit | (247,923 | ) | (203,689 | ) | |||||
Total stockholders’ equity | 18,127 | 39,338 | |||||||
Total liabilities and stockholders’ equity | $ | 69,679 | $ | 89,568 | |||||
Company Contact:
Darlene Deptula-Hicks, T2 Biosystems
SVP & Chief Financial Officer
ddeptula@t2biosystems.com
603-553-5803
Media Contact:
Amy Phillips, Feinstein Kean Healthcare
amy.phillips@fkhealth.com
412-327-9499
Investor Contact:
Chris Brinzey, Westwicke Partners
chris.brinzey@westwicke.com
339-970-2843