T2 Biosystems Reports Preliminary Fourth Quarter Results and Operational Progress
January 09 2017 - 6:30AM
-- On Track to Meet or Exceed Commercial
Guidance and Regulatory Timelines --
T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative
diagnostic products to improve patient health and deliver a strong
economic return to healthcare institutions, today announced
preliminary results for its 2016 fourth quarter.
Fourth Quarter Preliminary Performance and Recent
Operational 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. The company had set a target of
adding 150,000 new high-risk patients over a 12-month period
beginning on October 1, 2016 or before the targeted launch of the
T2BacteriaTM Panel in the fourth quarter of 2017. Closed
commitments in the quarter represent approximately 67 percent of
the 12-month target.
- 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.
- Estimated preliminary product revenue indicates year-over-year
growth by over 50 percent compared to the 2015 fourth quarter,
driven primarily by an increase in T2Candida® Panel sales due to
increased patient testing across the installed base.
- 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.
- Continued progress with T2Bacteria Panel, remaining on
track for an anticipated mid-2017 FDA filing.
- 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 million with the
potential option to draw an additional $10 million upon the
T2Bacteria Panel achieving FDA clearance.
- Announced a collaboration with Allergan to develop a novel
diagnostic panel that detects bacterial species and gram-negative
resistance for patients at risk for or suffering from sepsis.
Allergan’s physician-facing sales force may cooperatively market T2
Biosystems’ menu of sepsis diagnostics to targeted hospitals around
the world.
- Operating expenses are expected to be within a range of $11.5
million and $12.0 million.
“We are very pleased with our commercial progress and
operational results in the fourth quarter,” said John McDonough,
president and chief executive officer of T2 Biosystems. “During the
quarter, there was growth in testing of patients at many customer
sites and several exciting customer presentations at an infectious
disease conference that demonstrated the economic value of testing
patients with T2Candida. We also expanded our access to high-risk
patients by closing commitments with 18 hospitals that we expect to
become future customer success stories – an important growth driver
for T2.”
T2 Biosystems anticipates providing a complete update on its
fourth quarter and full-year 2016 results in mid-February. A formal
announcement of the date of the earnings release and conference
call will be issued in the coming weeks.
About T2 BiosystemsT2 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 platform, 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.
Forward-Looking StatementsThis 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 T2 Biosystems,
Inc.’s business, please refer to the Company’s Annual Report on
Form 10-K, filed with the Securities and Exchange Commission on
March 9, 2016, under the heading “Risk Factors,” and other filings
the Company makes with the Securities and Exchange Commission from
time to time. 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.
Media Contact:
Susan Heins, Pure Communications
susan@purecommunicationsinc.com
864-346-8336
Investor Contact:
Matt Clawson, Pure Communications
matt@purecommunicationsinc.com
949-370-8500
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