T2 Biosystems Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
Secured 14 New Instrument Contracts in the Fourth Quarter and 39 total New Instrument Contracts in 2018 that are expected to drive growth in Recurring Test Revenue
Confirms Guidance of a Doubling of Revenue in 2019; Provides Guidance of Securing 70 – 80 T2Dx Instruments Contracts in 2019
Fourth Quarter and Recent Business and Financial Performance Highlights:
- Reported fourth quarter total revenue of
$1.8 million, up 6% year-over-year.
- Reported fourth quarter product revenue of
$1.3 millionreflecting increased testing volume and stable capital sales as more new customers selected the reagent rental model.
- Secured a record 14 new contracts of T2Dx® Instruments in the fourth quarter, which was at the high end of 2H18 guidance.
- Increased targeted high-risk patients at newly contracted hospitals by over 80,000.
- In February, ranked in top ten of Fast Company’s 2019 Most Innovative Companies, Biotech Sector.
Full Year Business and Financial Performance Highlights:
- Reported full year total revenue of
$10.5 million, up 123% year-over-year.
- Reported full year product revenue of
$4.8 million, up 41% year-over-year.
- Launched the
T2Bacteria Panel, the flagship product in the T2Direct Diagnostics Portfolio™, following U.S. FDAclearance in May 2018.
- Secured 39 new contracts of T2Dx® Instruments for the full year, with 25 contracts in 2H18 following the T2Bacteria Panel FDA clearance.
- Increased targeted high-risk patients at contracted hospitals by 250,000.
- Closed equity financing raising
$52.6 millionin gross proceeds to support commercialization of the T2Direct Diagnostics™ product portfolio, including the ongoing launch of the T2Bacteria Panel.
“2018 was a year of major achievements for the Company highlighted by the
Mr. McDonough added, “In 2019 we expect to further expand our market opportunity with the
Additional Financial Results:
- Research revenues were
$0.5 millionin the fourth quarter, up 67% compared to $0.3 millionin last year’s fourth quarter. Research revenues were $5.7 millionin the full year, up 375% compared to $1.2 millionlast year.
- Costs and expenses in the fourth quarter, excluding cost of product revenue, were
$9.8 million, compared to last year’s fourth quarter costs and expenses of $9.7 million. Total costs and expenses include depreciation and non-cash stock compensation from stock options and performance-based restricted stock grants (RSUs) of $3.0 millioncompared to $1.8 millionin last year’s fourth quarter, an increase primarily due to the vesting of RSUs. Costs and expenses in the full year, excluding cost of product revenue, were $40.2 million, a 14% decrease over last year’s costs and expenses of $46.5 million. Total costs and expenses include depreciation and non-cash stock compensation from stock options and performance-based restricted stock grants (RSUs) of $12.3 millioncompared to $7.8 millionin last year, an increase primarily due to the vesting of RSUs.
- Operating margins in the fourth quarter were a loss of
$13.6 million, a 6% decrease over last year’s fourth quarter operating margin loss of $14.4 million. Operating margins in full year were a loss of $45.1 million, a 16% decrease over last year’s operating margin loss of $53.9 million.
Weighted average shares outstanding were 44.1 million for the fourth quarter and 40.6 million for the full year, compared to 35.7 million and 32.1 million in the same periods last year.
The company is providing the following full year 2019 financial guidance:
- Total revenue is expected to double in 2019 compared to
$10.5 millionin 2018. First quarter 2019 revenue is expected to be in the range of $1.3 million to $1.5 million, reflecting continuing adoption of T2Bacteria and T2Candida Paneltest sales and expanding T2Dx® Instruments reagent rentals and sales in the U.S. and internationally.
- The company expects to secure contracts of 70 to 80 T2Dx® Instruments in 2019, including 8 to 10 contracts in the first quarter 2019, which follows the historical seasonal pattern of contracts in the fourth quarter being greater than the first quarter.
- Operating expenses, excluding cost of product revenue, are expected to be
$10.5 million to $11.5 millionin the first quarter 2019. Total costs and expenses will include non-cash depreciation and stock based compensation expenses from stock options and RSUs of approximately $3.0 million.
Management will host a conference call today with the investment community at
About T2 Biosystems:
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.
Gina Kent, Vault Communications
Zack Kubow, W2O Group
T2 Biosystems, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Costs and expenses:|
|Cost of product revenue||15,404||12,028||6,872|
|Research and development||14,489||23,733||24,009|
|Selling, general and administrative||25,697||22,757||24,077|
|Total costs and expenses||55,590||58,518||54,958|
|Loss from operations||(45,090||)||(53,852||)||(50,878||)|
|Interest expense, net||(6,682||)||(8,907||)||(4,098||)|
|Other income, net||619||331||172|
|Net loss and comprehensive loss||(51,153||)||(62,428||)||(54,804||)|
|Net loss per share — basic and diluted||$||(1.26||)||$||(1.94||)||$||(2.11||)|
|Weighted-average number of common shares used in computing net loss per share — basic and diluted||40,558,826||32,131,512||26,015,751|
T2 Biosystems, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share data)
|December 31,||December 31,|
|Cash and cash equivalents||$||50,805||$||41,799|
|Prepaid expenses and other current assets||1,340||708|
|Total current assets||56,608||44,318|
|Property and equipment, net||7,315||10,015|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||6,073||6,218|
|Current portion of lease incentives||268||246|
|Total current liabilities||52,297||51,782|
|Notes payable, net of current portion||—||1,008|
|Lease incentives, net of current portion||492||731|
|Deferred revenue, net of current portion||133||—|
|Commitments and contingencies|
|Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding||—||—|
|Common stock, $0.001 par value; 200,000,000 shares authorized; 44,175,441 and 35,948,900 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively||44||36|
|Additional paid-in capital||328,514||267,421|
|Total stockholders’ equity||11,387||1,340|
|Total liabilities and stockholders’ equity||$||64,309||$||54,861|
Source: T2 Biosystems, Inc.