T2 Biosystems Announces Preliminary Third Quarter 2022 Financial Results and Updates 2022 Financial Outlook
12 October 2022 - 11:35PM
T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in
the rapid detection of sepsis-causing pathogens and antibiotic
resistance genes, today announced preliminary unaudited financial
results for the third quarter ended September 30, 2022.
Recent Highlights
(unaudited)
- Achieved estimated third quarter
total revenue of approximately $3.7 million, including estimated
product revenue of approximately $2.6 million, representing
decreases of 50% and 40% respectively, compared to the prior year
period, driven by lower sales of COVID-19 tests and reduced BARDA
revenue offset by increased sepsis test sales.
- Achieved estimated sepsis and
related revenue (non-COVID product revenue) of approximately $2.3
million, representing a record number for a single quarter and an
increase of 24% compared to the prior year period.
- Executed contracts for 11 T2Dx®
Instruments during the third quarter, including 3 in the U.S. and 8
outside the U.S., compared to 8 total instruments in the prior year
period.
- Sold a second T2Dx Instrument to
one of the leading U.S. laboratory service providers in October, to
be deployed for sepsis testing in one of the provider’s
managed-hospital laboratories.
- Received Breakthrough Device
Designation from the U.S. Food and Drug Administration for the
T2Lyme™ Panel and submitted for development funding through the
Lyme Innovation Accelerator (LymeX).
- Completed all milestones for Option
2B of the multiple-year product development contract with BARDA,
including milestones advancing the U.S. clinical trials for the
T2Resistance® Panel and the T2Biothreat™ Panel, and advancing the
development of the next-generation instrument and the comprehensive
sepsis panel.
- Received Option 3 of the contract
with BARDA, valued at $3.7 million, to finalize U.S. clinical
trials and complete FDA submission for the T2Biothreat™ Panel and
the T2Resistance® Panel, which we plan to submit to the FDA in the
fourth quarter of 2022 and early 2023, respectively.
- Expanded commercialization into the
Baltic region, including Lithuania, Latvia, and Estonia, by
entering into a distribution agreement.
- Cash, cash equivalents, marketable
securities, and restricted cash totaled $21.5 million as of
September 30, 2022. Third quarter cash used in operations totaled
$12.1 million, cash used to purchase other working capital and
equipment was $3.6 million, and cash provided by ATM proceeds was
$22.9 million.
“Our third quarter results demonstrate continued
market penetration with our sepsis products, driven by global
adoption of our T2Dx Instrument and increased sales of our sepsis
test panels, including 12% growth from the prior year period and
26% growth from the second quarter of 2022. We have updated our
2022 financial outlook to reflect a moderated but continued growth
in sepsis and related product sales, and reductions in BARDA
revenue and COVID-19 sales. While the conversion of COVID-driven
instruments to sepsis testing has been slower than expected, this
continues to represent a meaningful growth opportunity and is an
area of focus for our U.S. sales team,” stated John Sperzel,
Chairman and CEO of T2 Biosystems. “Our new product pipeline
includes several near-term potential growth drivers that we believe
offer highly-differentiated value to customers, including the
T2Biothreat Panel, the T2Resistance Panel, and the T2Lyme Panel. We
are excited about the future and believe we can drive sustainable
growth by providing clinicians with products that enable faster,
targeted therapy.“
Updated 2022 Financial
OutlookThe Company now expects full year 2022 total
revenue of $22.0 to $23.0 million, including product revenue of
$11.5 to $12.0 million and research contribution revenue of $10.5
to $11.0 million. The Company now expects to close 50 to 55 T2Dx
Instrument contracts in 2022.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, 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, the T2Bacteria®
Panel, the T2Candida® Panel, the T2Resistance® Panel, and the
T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the T2Biothreat™ Panel, the T2Cauris™
Panel, and T2Lyme™ Panel, as well as next-generation products for
the detection of bacterial and fungal pathogens and associated
antimicrobial resistance markers.
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, including, without limitation, statements regarding our
revenue results and cash balance, financial outlook, instrument
contracts, timing of filing of an FDA submission, anticipated
strategic priorities, product demand, commitments or opportunities,
and growth expectations or targets, as well as statements that
include the words “expect,” “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, 2021, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 23, 2022, and other filings
the Company makes with the SEC from time to time, including our
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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.
Investor Contact:Philip Trip Taylor, Gilmartin
Groupir@T2Biosystems.com 415-937-5406
T2 Biosystems (NASDAQ:TTOO)
Historical Stock Chart
From Apr 2024 to May 2024
T2 Biosystems (NASDAQ:TTOO)
Historical Stock Chart
From May 2023 to May 2024