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Recent Operational and Fourth Quarter Performance Highlights:
- Secured commitments in the fourth quarter that will provide access to an estimated 100,000 additional patients annually considered to be at high risk for sepsis infections across 18 new hospitals in the U.S. and Europe.
- Secured eight new contracts covering those 18 hospitals in the quarter; four contracts, representing 14 hospitals in the U.S. and four with European institutions.
- Expanded European presence to eight countries via contracts with international distributors.
- Continued progress with T2Bacteria™ Panel, remaining on track for an anticipated mid-2017
- Recently received issuance of a key patent related to T2 Magnetic Resonance (T2MR®) in the field of hemostasis that enables multiple measurements from small samples of blood to determine patients’ risks of bleeding and clotting.
- Reported revenue of
$910,000, including $579,000of product revenue. Product revenue grew nearly 69% from the fourth quarter of 2015 driven primarily by an increase in T2Candida® Panel sales due to increased patient testing across the installed base.
- Executed a debt refinancing that positively impacts cash flow with a minimum of three years of interest-only payments while extending the company’s borrowing limit to
$40 millionwith the potential option to draw an additional $10 millionupon the T2Bacteria Panelachieving FDAclearance.
- Ended 2016 with approximately
$73.5 millionin cash and cash equivalents.
Full-Year Operational and Performance Highlights:
- Increased worldwide installed base to include 143 hospitals with access to the T2Dx® Instrument, representing an estimated 445,000 high risk patients annually who are considered to be at high risk of sepsis infections – an approximate 95% percent year-over-year increase in high-risk patients.
- Announced a collaboration with
Allerganto develop a novel diagnostic panel to detect bacterial species and gram-negative resistance for patients at risk for or suffering from sepsis. Allerganis granted an option to cooperatively market T2 Biosystems’ menu of sepsis focused diagnostics to targeted hospitals around the world through Allergan’s leading physician-facing institutional sales force.
- Signed a multi-year agreement with Bayer to provide T2MR for research and development efforts in blood coagulation disorders. This collaboration will focus on developing tools and evaluating assays to help drive drug discovery and biomarker research for select Bayer hemostasis-related programs.
- Announced a
$40 millioncommon stock equity investment by Canon U.S.A.
- Welcomed four positive
T2Candida Panelcustomer poster presentations at IDWeek ( October 26-30; New Orleans, LA); including Henry Ford Hospital, which reported savings of approximately $2 millionover a 12-month period, after implementing widespread T2Candida Paneltesting.
- Grew revenue to
$4.1 millionin calendar year 2016, including $1.75 millionof product revenue. Product revenue grew 191% compared to full-year 2015.
“2016 was a transformative year for T2. We are especially encouraged by our overall performance in the second half of 2016 and expect that momentum to continue into 2017,” said
McDonough continued, “Looking ahead, 2017 is poised to be a year of growth and expansion. We expect growth to be driven by continued customer success stories that drive adoption and patient testing with T2Candida along with an expanded menu of diagnostic tests with the expected
Total revenue in the fourth quarter of 2016 was
Total revenue for the full-year of 2016 was
Total operating expenses increased for calendar 2016 due to an expansion of commercial activities in continued investments in the product pipeline, including T2Bacteria and T2Lyme.
The Company’s balance sheet as of
Anticipated Upcoming Corporate Milestones
- Completing the clinical trial for the
T2Bacteria Paneland filing for market clearance with the FDAby mid-2017.
- Earning a CE mark that will enable the launch of the
T2Bacteria Panelin Europein the second half of 2017.
- Collaborating with European distributors to enable the commercial launch of the
T2Bacteria Panelin the second half of 2017.
- Completing preclinical studies for the T2Lyme™ Panel in 2017, which will lead to an expected
FDAclinical trial in 2018.
- Commencing pre-clinical studies for the
Gram Negative Resistance Panel, in 2018.
- Publication of additional customer success stories that highlight the benefit of T2MR technology to patient health and hospital economics.
- Expanding our presence to additional countries beyond our current European footprint.
Previously, the Company targeted an increase in the number of high-risk patients at customer facilities by 150,000 patients for the 12-month period ended
Additionally, the Company anticipates higher product revenue in the first quarter of 2017 from an increase in
The Company anticipates total operating expenses for the first quarter of 2017 to be between
The Company is forecasting weighted average shares for the first quarter of 2017 to be 30.6 million and, for the full-year 2017, the Company is forecasting weighted average shares of 31 million.
T2 Biosystems’ management will discuss the Company’s financial results for the fourth quarter and year ended
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products 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 unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.
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
Matthew McKillip, T2 Biosystemsmmckillip@t2biosystems.com 518-577-3466 Investor Contact: Tucker Elcock, Teneo Strategy Tucker.Elcock@teneostrategy.com 212-886-9319