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EX-99.2 - EX-99.2 - T2 Biosystems, Inc.a17-18988_1ex99d2.htm
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Exhibit 99.1

 

T2 BIOSYSTEMS REPORTS SECOND QUARTER 2017 FINANCIAL RESULTS; PROVIDES COMPANY UPDATE

 

Sequential Quarterly Product Revenue Growth of 16.5%

 

LEXINGTON, MA, August 3, 2017 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, announced today operating highlights and financial results for the second quarter ended June 30, 2017.

 

Second Quarter Business and Financial Performance Highlights:

 

·                  Second quarter product revenue was $735,000, a $584,000 increase from the second quarter of 2016.

·                  Reported sequential quarterly product revenue growth of 16.5%, ahead of the expected 10% revenue growth target projected last quarter.

·                  Exceeded expectations by securing commitments from new hospitals in the United States and Europe that provide access to an estimated 50,000 additional patients annually considered to be at high risk for sepsis infections.

·                  Secured contracts with five new hospitals, including three in the United States and two in Europe.

·                  Obtained European CE Mark for the T2Bacteria Panel allowing for the sale and distribution of the T2Bacteria Panel in Europe and other countries that accept the CE mark.

·                  Closed the first European hospital contract for T2Bacteria that could begin testing patients for clinical purposes later this year.

·                  Closed four contracts with hospitals in the United States for use of the T2Bacteria Panel under a Research Use Only program.

·                  Featured in seven sessions at the American Society for Microbiology (ASM) Conference highlighting the positive impact of T2Candida and T2Bacteria.

·                  Testimonials from three prestigious medical institutions took place at ASM highlighting their experience with T2Candida and T2Bacteria.

·                  Expanded the company’s international partner channel to seven distributors covering more than 20 countries.

·                  Published data in the Journal of Clinical Microbiology showing evidence of the potential superiority of T2MR’s ability to detect Lyme disease-causing bacteria.

 

“We had a terrific quarter and are pleased with both our financial and operational performance through the first six months of 2017,” said John McDonough, T2 Biosystems’ Chief Executive Officer.  “We have made important progress on our strategic priorities, highlighted by the expansion of our T2Sepsis™ Solution with the CE Mark of T2Bacteria® in Europe. T2Candida® continues to expand in its usage in hospitals around the world while customer testimonials continue to grow. Early data for T2Lyme is encouraging and shows the tremendous opportunity for our T2MR®-powered diagnostic product pipeline.  Furthermore, we are pleased to be increasing our 2017 growth targets for the third quarter and we look forward to the FDA filing of T2Bacteria within 4-to-6 weeks which keeps us on track with a potential FDA clearance by the end of 2017.”

 



 

Second Quarter Financial Results

 

Product revenue for the second quarter of 2017 increased by $584,000, from the second quarter of 2016, to $735,000. The increase in product revenue was primarily due to increased usage of the T2Candida panel at existing customer sites, new hospitals beginning to test patients for clinical purposes and sales of T2Dx instruments.  Research revenue in the second quarter of 2017 of $221,000 exceeded our guidance of expected second quarter research revenue of less than $100,000. Research revenue in the second quarter compared to the prior year quarter declined as expected, primarily due to lower revenue recognition from our co-development agreement with Canon US Life Sciences, which decreased $618,000. Operating expenses, excluding cost of product revenue, increased $359,000 to $12.9 million, from $12.5 million in the second quarter of 2016. The increase in operating expense was primarily driven by a $743,000 increase in research and development expenses, offset by a $384,000 reduction in SG&A expenses.

 

Net loss attributable to common shareholders for the second quarter of 2017 was $15.5 million, or $0.50 per basic and diluted share, compared to a net loss of $14.0 million or $0.58 per basic and diluted share in the same period prior year.

 

Outlook for Remainder of 2017

 

The company is updating guidance for 2017, which includes:

 

·                  The T2Bacteria Panel filing with the U.S. FDA is expected within the next 4-to-6 weeks.

·                  Product revenue growth of at least 20% sequentially is projected in third quarter of 2017.

·                  The target for increasing the number of high-risk patients at customer facilities under contract for the 12-month period ending September 30, 2017 is being increased to 220,000 high risk patients (as compared to the initial estimate of 150,000 patients stated in November 2016 which was increased to 200,000 in May 2017).

·                  Operating expenses, excluding cost of product revenue, for the third quarter projected in the range of $12.5 million to $12.9 million.

 

Conference Call

 

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 1-877-407-9208 (U.S.) or 1-201-493-6784 (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 is dedicated to developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx Instrument and T2Candida Panel targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance technology, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost

 



 

of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. 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. 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, 2016, filed with the U.S. Securities and Exchange Commission, or SEC, on March 15, 2017, 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, it disclaims any obligation to do so, even if subsequent events cause its views to change. 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.

 

Company Contact:

Darlene Deptula-Hicks, T2 Biosystems

SVP & Chief Financial Officer

ddeptula@t2biosystems.com

603-553-5803

 

Media Contact:

Matthew McKillip, T2 Biosystems

mmckillip@t2biosystems.com

518-577-3466

 

Investor Contact:

Chris Brinzey, Westwicke Partners

chris.brinzey@westwicke.com

339-970-2843

 



 

T2 BIOSYSTEMS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

June 30, 
2017

 

December 31, 
2016

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

46,134

 

$

73,488

 

Accounts receivable

 

981

 

327

 

Prepaid expenses and other current assets

 

660

 

820

 

Inventories, net

 

1,014

 

803

 

Total current assets

 

48,789

 

75,438

 

Property and equipment, net

 

14,510

 

13,589

 

Restricted cash

 

260

 

260

 

Other assets

 

218

 

281

 

Total assets

 

$

63,777

 

$

89,568

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,660

 

$

962

 

Accrued expenses and other current liabilities

 

4,701

 

4,908

 

Current portion of notes payable

 

1,365

 

1,269

 

Deferred revenue

 

2,494

 

2,445

 

Current portion of lease incentives

 

248

 

301

 

Total current liabilities

 

10,468

 

9,885

 

Notes payable, net of current portion

 

39,908

 

39,504

 

Lease incentives, net of current portion

 

771

 

792

 

Other liabilities

 

305

 

49

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2017 and December 31, 2016

 

 

 

Common stock, $0.001 par value; 200,000,000 shares authorized; 30,763,919 and 30,482,712 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively

 

32

 

30

 

Additional paid-in capital

 

246,141

 

242,997

 

Accumulated deficit

 

(233,848

)

(203,689

)

Total stockholders’ equity

 

12,325

 

39,338

 

Total liabilities and stockholders’ equity

 

$

63,777

 

$

89,568

 

 



 

T2 BIOSYSTEMS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

Revenue:

 

 

 

 

 

 

 

 

 

Product revenue

 

$

735

 

$

151

 

$

1,366

 

$

588

 

Research revenue

 

221

 

839

 

531

 

1,498

 

Total revenue

 

956

 

990

 

1,897

 

2,086

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

1,989

 

1,781

 

3,617

 

2,807

 

Research and development

 

7,112

 

6,369

 

13,697

 

12,958

 

Selling, general and administrative

 

5,759

 

6,143

 

11,633

 

12,347

 

Total costs and expenses

 

14,860

 

14,293

 

28,947

 

28,112

 

Loss from operations

 

(13,904

)

(13,303

)

(27,050

)

(26,026

)

Interest expense, net

 

(1,654

)

(805

)

(3,291

)

(1,540

)

Other income, net

 

102

 

62

 

181

 

94

 

Net loss and comprehensive loss

 

$

(15,456

)

$

(14,046

)

$

(30,160

)

$

(27,472

)

Net loss per share — basic and diluted

 

$

(0.50

)

$

(0.58

)

$

(0.99

)

$

(1.13

)

Weighted-average number of common shares used in computing net loss per share — basic and diluted

 

30,661,200

 

24,321,310

 

30,595,933

 

24,270,041