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Confirms 2019 Guidance of a Doubling of Revenue and Securing 70 – 80 T2Dx Instrument Contracts
LEXINGTON, Mass., May 02, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, announced today the operating highlights and financial results for the first quarter ended March 31, 2019.
First Quarter and Recent Business and Financial Performance Highlights:
“We delivered a strong start to 2019 with revenue and new system contracts that surpassed our guidance,” said John McDonough, president and chief executive officer. “Our commercial team is building momentum with ongoing and new customers alike, and we are pleased to be engaging on a more regular basis with motivated institutions that understand T2Bacteria® Panels’ unique value proposition and potential to improve clinical outcomes. During the quarter we also helped several of the first T2Bacteria® Panel customers in the U.S. complete their training and validation process and begin testing patients. We are pleased with the initial feedback and testing volumes and look forward to bringing more customers online in growing numbers throughout the coming quarters.”
Additional Financial Results:
Weighted average shares outstanding were 44.3 million for the first quarter, compared to 36.0 million in the same period last year.
The company is reiterating its full year 2019 financial guidance and providing second quarter 2019 financial guidance as follows:
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 1-855-327-6838 (U.S.) or 1-631-891-4304 (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.
About T2 Biosystems:
T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, 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, and T2Bacteria® 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.
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, 2018, filed with the U.S. Securities and Exchange Commission, or SEC, on March 14, 2019, 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.
Gina Kent, Vault Communications
Zack Kubow, W2O Group
T2 BIOSYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|Three Months Ended|
|Grant contribution revenue||329||—|
|Costs and expenses:|
|Cost of product revenue||4,388||3,273|
|Research and development||3,901||4,718|
|Selling, general and administrative||7,055||5,755|
|Total costs and expenses||15,344||13,746|
|Loss from operations||(13,559||)||(11,435||)|
|Interest expense, net||(1,782||)||(1,568||)|
|Other income, net||194||90|
|Net loss and comprehensive loss||$||(15,147||)||$||(12,913||)|
|Net loss per share — basic and diluted||$||(0.34||)||$||(0.36||)|
|Weighted-average number of common shares used in computing|
net loss per share — basic and diluted
T2 BIOSYSTEMS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
|Cash and cash equivalents||$||37,400||$||50,805|
|Prepaid expenses and other current assets||1,741||1,340|
|Total current assets||43,578||56,608|
|Property and equipment, net||7,128||7,315|
|Operating lease assets||4,463||—|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||7,784||6,073|
|Current portion of lease incentives||—||268|
|Total current liabilities||53,735||52,297|
|Lease incentives, net of current portion||—||492|
|Operating lease liabilities, net of current portion||3,259||—|
|Deferred revenue, net of current portion||141||133|
|Commitments and contingencies|
|Stockholders’ (deficit) equity:|
|Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and|
outstanding at March 31, 2019 and December 31, 2018
|Common stock, $0.001 par value; 200,000,000 shares authorized; 44,339,243 and 44,175,441 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively||44||44|
|Additional paid-in capital||330,694||328,514|
|Total stockholders’ (deficit) equity||(1,580||)||11,387|
|Total liabilities and stockholders’ equity||$||55,555||$||64,309|
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