T2 Biosystems Reports First Quarter 2017 Results and Corporate Update
Recent Operational and First Quarter Performance Highlights:
- Secured commitments from new hospitals in the U.S. and
Europe that will provide access to an estimated 30,000 additional patients annually considered to be at high risk for sepsis infections. - Secured contracts with 2 hospitals: 1 in the U.S. and 1 in
Europe . - Streamlined placements of instruments at hospital locations in the U.S. by reallocating instruments from small hospitals with little to low T2Candida® patient testing volumes to more productive locations.
- Ended the quarter with contracts in place representing 126 hospitals in the U.S., providing access to approximately 420,000 patients at high risk of infections that could be tested with T2Candida or in the future, T2Bacteria™.
- Reported revenue of
$941,000 , including$631,000 of product revenue. Product revenue grew nearly 45% compared to the first quarter of 2016, driven primarily by instrument sales and increased patient testing across the installed base. - Continued progress with development of T2Bacteria, which remains on track for an anticipated mid-2017
FDA filing. - Expanded European presence now includes 10 countries where the T2 platform is marketed through international distributors.
- Presentations by T2 users on the performance and economic and clinical impact of the T2Sepsis™ Solution at ECCMID (
April 22-25 ;Vienna, Austria ); including Patricia Muñoz MD, PhD, from Hospital General Universitario Gregorio Marañón inMadrid, Spain ,Giulia De Angelis , M.D. from Policlinico Universitario Agostino Gemelli inRome, Italy , andSandy Estrada , Pharm.D., BCPS fromLee Memorial Health System inFort Myers, FL. - Total operating expenses for the first quarter of 2017 were
$12.5 million , compared to$12.8 million for the first quarter of 2016. Research and development expenses remained consistent year over year, while a reduction in SG&A expenses was due to strong cost management. - Ended the first quarter with approximately
$58.8 million in cash and cash equivalents.
“We continued to execute against our strategic priorities in the first quarter,” said
Financial Results
Total revenue in the first quarter of 2017 was
Total operating expenses for the first quarter of 2017 were
The net loss applicable to common shareholders for the first quarter of 2017 was
The Company’s balance sheet as of
Anticipated Upcoming Corporate Milestones
- Completing the clinical trial for T2Bacteria and filing for market clearance with the
FDA by mid-2017. - Obtaining a CE mark that will enable the launch of T2Bacteria in
Europe in the second half of 2017. - Commercially launching T2Bacterial in
Europe in the second half of 2017 through the established European distributor channel. - Publication of additional customer success stories that highlight the benefit of T2MR technology to patient health and hospital economics. Presentations will include data from hospitals on use of T2Bacteria and T2Candida.
- Completing pre-clinical studies for the T2Lyme™ Panel in 2017, which is expected to lead to an
FDA clinical trial in 2018, in partnership withCanon U.S.A. - Commencing pre-clinical studies for the Gram-negative resistance panel in 2018 in partnership with
Allergan . - Expanding our commercial efforts in European countries beyond our current footprint.
Outlook
The Company continues to target an increase in the number of high-risk patients at customer facilities under contract by 200,000 patients for the 12-month period ending
Additionally, the Company anticipates continued growth of product revenue in the second quarter of 2017 from an increase in
The Company anticipates total operating expenses for the second quarter of 2017 to be between
The Company anticipates research revenue to be below
The Company is forecasting weighted average shares for the second quarter of 2017 to be 30.7 million.
Conference Call
T2 Biosystems’ management will discuss the Company’s financial results for the first quarter ended
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. These forward-looking statements are based on management's 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, the performance of the Company's diagnostic products and the ability to bring such products to market. 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. For more information on risk factors for
T2 Biosystems, Inc. | ||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
(In thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
Three Months Ended March 31, |
||||||||
2017 | 2016 | |||||||
Revenue: | ||||||||
Product revenue | $ | 631 | $ | 437 | ||||
Research revenue | 310 | 659 | ||||||
Total revenue | 941 | 1,096 | ||||||
Costs and expenses: | ||||||||
Cost of product revenue | 1,627 | 1,026 | ||||||
Research and development expenses | 6,585 | 6,589 | ||||||
Selling, general and administrative expenses | 5,874 | 6,204 | ||||||
Total costs and expenses | 14,086 | 13,819 | ||||||
Loss from operations | (13,145 | ) | (12,723 | ) | ||||
Interest expense, net | (1,637 | ) | (735 | ) | ||||
Other income, net | 79 | 32 | ||||||
Net loss and comprehensive loss | $ | (14,703 | ) | $ | (13,426 | ) | ||
Net loss per share - basic and diluted | $ | (0.48 | ) | $ | (0.55 | ) | ||
Weighted-average number of common shares used in computing net loss per share - basic and diluted | 30,531,180 | 24,218,767 | ||||||
T2 Biosystems, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(In thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
March 31, | December 31, | |||||||
2017 | 2016 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 58,822 | $ | 73,488 | ||||
Accounts receivable | 409 | 327 | ||||||
Prepaid expenses and other current assets | 931 | 820 | ||||||
Inventories, net | 489 | 803 | ||||||
Total current assets | 60,651 | 75,438 | ||||||
Property and equipment, net | 14,468 | 13,589 | ||||||
Restricted cash | 260 | 260 | ||||||
Other assets | 280 | 281 | ||||||
Total assets | $ | 75,659 | $ | 89,568 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,161 | $ | 962 | ||||
Accrued expenses and other current liabilities | 4,060 | 4,908 | ||||||
Current portion of notes payable | 1,316 | 1,269 | ||||||
Deferred revenue | 2,127 | 2,445 | ||||||
Current portion of lease incentives | 249 | 301 | ||||||
Total current liabilities | 8,913 | 9,885 | ||||||
Notes payable, net of current portion | 39,750 | 39,504 | ||||||
Lease incentives, net of current portion | 791 | 792 | ||||||
Other liabilities | 175 | 49 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2017 and December 31, 2016 |
- | - | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2017 and December 31, 2016; 30,594,342 and 30,482,712 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively |
31 | 30 | ||||||
Additional paid-in capital | 244,391 | 242,997 | ||||||
Accumulated deficit | (218,392 | ) | (203,689 | ) | ||||
Total stockholders’ equity | 26,030 | 39,338 | ||||||
Total liabilities and stockholders’ equity | $ | 75,659 | $ | 89,568 | ||||
Media Contact:Matthew McKillip ,T2 Biosystems mmckillip@t2biosystems.com 518-577-3466 Investor Contact:Tucker Elcock , Teneo Strategy Tucker.Elcock@teneostrategy.com 212-886-9319