Full Press Release Details
T2 Biosystems Reports First Quarter 2018 Financial Results and Provides Corporate Update
Quarterly Product Revenue Up 66% Year-Over-Year
On Track for Potential FDA Clearance of T2Bacteria Panel in the Second Quarter 2018
LEXINGTON, Mass., May 8, 2018 (GLOBE NEWSWIRE) T2 Biosystems, Inc. (NASDAQ:TTOO) an emerging leader in the development and commercialization of
innovative medical diagnostic products for critical unmet needs in healthcare, announced today operating highlights and financial results for the first quarter ended March 31, 2018.
First Quarter Business and Financial Performance Highlights:
The first quarter was a positive start to the year for our core business, highlighted by 66% year-over-year product revenue growth, the expansion of our
installed base and prudent expense management. There continues to be positive momentum in the market for our technology, with several new peer-reviewed publications demonstrating our superior performance and our new collaboration with CARB-X focused on a broad-based diagnostic panel for sepsis-causing bacterial infections, said president and chief executive officer John McDonough. Perhaps most importantly, there is robust and growing
customer interest in the T2Bacteria Panel, which remains on track for potential FDA clearance in the second quarter of 2018. We anticipate this will be an inflection point for our business based on a significant expansion of our market opportunity
and a positive shift in our growth trajectory.
Additional Financial Results:
Weighted average shares outstanding were 36.0 million this quarter compared to 35.9 million last
quarter and 30.6 million in last year s first quarter.
The company provides the following guidance for the second quarter 2018:
The company expects to provide full-year 2018 financial guidance
upon FDA clearance of the T2Bacteria Panel.
Management will host a conference call today with the investment community at 4:30 p.m. Eastern Time to discuss the financial results and other business
developments. Interested parties may access the live call via telephone by dialing 1-877-300-8521 (U.S.) or 1-412-317-6026 (International). To listen to the live call via T2 Biosystems website, go to www.t2biosystems.com, in the
Investors/Events & Presentations section. A webcast replay of the call will be available following the conclusion of the call, also in the Investors/Events & Presentations section of the website.
T2 Biosystems, an emerging
leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, improves patient care and reduces the cost of healthcare by helping clinicians effectively treat patients faster than
ever before. T2 Biosystems products include the T2Dx Instrument, T2Candida Panel, and the T2Bacteria Panel and are powered by the proprietary T2 Magnetic Resonance technology,
or T2MR . T2Bacteria Panel is commercially available in Europe and other countries that accept the CE Mark and is available for research use only in the U.S. T2 Biosystems has
an active pipeline of future products including additional species and antibiotic resistance for detection of sepsis pathogens, as well as tests for Lyme disease. For more information, please visit www.t2biosystems.com.
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 FDA filings or clearances and anticipated operating expenses, as well as statements that include the words expect, intend,
plan , believe , project , forecast , estimate, may, should, anticipate, and similar statements of a future or forward looking nature. 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, (i) any inability to (a) realize anticipated benefits from
commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth
assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes;
(iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. Risk Factors in the company s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission, or SEC, on March 19, 2018, and other filings the company makes with the SEC from time to time. 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. Any such forward-looking statements represent management s estimates as of the date of
this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one
should assume that the Company s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the
company s views as of any date subsequent to the date of this press release.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 1,048 | $ | 631 | ||||
| Research revenue | 1,263 | 310 | ||||||
| Total revenue | 2,311 | 941 | ||||||
| Costs and expenses: | ||||||||
| Cost of product revenue | 3,273 | 1,627 | ||||||
| Research and development | 4,718 | 6,585 | ||||||
| Selling, general and administrative | 5,755 | 5,874 | ||||||
| Total costs and expenses | 13,746 | 14,086 | ||||||
| Loss from operations | (11,435 | ) | (13,145 | ) | ||||
| Interest expense, net | (1,568 | ) | (1,637 | ) | ||||
| Other income, net | 90 | 79 | ||||||
| Net loss and comprehensive loss | $ | (12,913 | ) | $ | (14,703 | ) | ||
| Net loss per share basic and diluted | $ | (0.36 | ) | $ | (0.48 | ) | ||
| Weighted-average number of common shares used in computing net loss per share basic and diluted | 35,978,306 | 30,531,180 |
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share
| March 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,733 | $ | 41,799 | ||||
| Accounts receivable | 582 | 467 | ||||||
| Prepaid expenses and other current assets | 626 | 708 | ||||||
| Inventories | 2,082 | 1,344 | ||||||
| Total current assets | 33,023 | 44,318 | ||||||
| Property and equipment, net | 8,710 | 10,015 | ||||||
| Restricted cash | 180 | 260 | ||||||
| Other assets | 206 | 268 | ||||||
| Total assets | $ | 42,119 | $ | 54,861 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 779 | $ | 648 | ||||
| Accrued expenses and other current liabilities | 5,606 | 6,218 | ||||||
| Derivative liability | 2,096 | 2,238 | ||||||
| Notes payable | 41,303 | 40,696 | ||||||
| Deferred revenue | 887 | 1,736 | ||||||
| Current portion of lease incentives | 251 | 246 | ||||||
| Total current liabilities | 50,922 | 51,782 | ||||||
| Notes payable, net of current portion | 609 | 1,008 | ||||||
| Lease incentives, net of current portion | 675 | 731 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2018 and December 31, 2017 | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized; 36,019,883 and 35,948,900 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 36 | 36 | ||||||
| Additional paid-in capital | 268,807 | 267,421 | ||||||
| Accumulated deficit | (278,930 | ) | (266,117 | ) | ||||
| Total stockholders (deficit) equity | (10,087 | ) | 1,340 | |||||
| Total liabilities and stockholders equity | $ | 42,119 | $ | 54,861 |
Tom Langford, Feinstein Kean Healthcare
Matthew Clawson, W2O Group