T2 Biosystems Announces Preliminary Third Quarter 2023 Financial Results and Business Updates
2023年10月13日 - 5:05AM
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, 2023 and business
updates.
Recent Financial and Operational
Highlights
- Achieved preliminary third quarter
2023 total revenue of $1.5 million, comprised entirely of product
revenue, a decrease of 60% compared to the prior year period,
primarily due to a $1.0 million reduction in BARDA revenue.
- Achieved sepsis test panel revenue
of $1.1 million, a decrease of 31% compared to the prior year
period, primarily due to ending the third quarter with a sepsis
test backorder of $380,000.
- Executed contracts for 5 T2Dx
Instruments during the third quarter, including 2 in the U.S. and 3
internationally.
- Completed installation for all
seven initial T2Dx® Instruments sold under a multi-year contract
with a European distributor for T2Dx Instruments and sepsis test
panels for Poland.
- Strengthened balance sheet by
converting $10.0 million, or approximately 20%, of term loan debt
with CRG Servicing LLC in exchange for shares of T2 Biosystems
equity.
- Cash and cash equivalents totaled
$24.3 million as of September 30, 2023, and the Company raised an
additional $21.9 million in net proceeds through ATM sales during
the third quarter.
Recent Pipeline and Clinical
Highlights
- Received FDA 510(k) clearance for
the T2Biothreat™ Panel, a direct-from-blood diagnostic test; only
FDA-cleared multi-target biothreat test developed/manufactured by a
U.S. owned company.
- Received FDA Breakthrough Device
designation for Candida auris test, a direct-from-blood molecular
diagnostic test, marking the third T2 Biosystems’ product to
receive this designation.
- Advanced the T2Resistance Panel
toward FDA 510(k) submission, which we expect to occur during the
first quarter of 2024.
- Filed FDA 510(k) submission to
expand the FDA-cleared T2Bacteria® Panel to include the detection
of Acinetobacter baumannii.
- The Company’s milestone-based
product development contract with BARDA ended on September 15,
2023, upon the completion of Option 3.
“Our third quarter results were highlighted by
the receipt of FDA 510(k) clearance for the T2Biothreat Panel and
510(k) submission to add Acinetobacter baumannii detection to the
FDA-cleared T2Bacteria Panel, which are both intended to create
growth opportunities by expanding the test menu on our FDA-cleared
T2Dx Instrument,” stated John Sperzel, Chairman and CEO of T2
Biosystems. “Operationally, we have taken aggressive measures to
address the sepsis test backorder, we have significantly improved
our balance sheet by raising capital and by reducing our debt, and
we have taken steps to maintain our Nasdaq listing, all of which
will allow the Company to further advance our corporate
priorities.”
Preliminary Third Quarter 2023 Financial
ResultsTotal revenue for the third quarter of 2023 was
$1.5 million, comprised entirely of product sales, a 60% decrease
compared to $3.7 million in the prior year period, driven by a $1.0
million reduction in BARDA revenue, a $0.4 million sepsis test
backorder, a $0.3 million reduction in international T2Dx
Instrument sales, and a $0.3 million reduction in COVID-19 test
sales.
Cash and cash equivalents totaled $24.3 million
as of September 30, 2023. The Company raised $21.9 million in net
proceeds through ATM sales in the third quarter of 2023 and on July
6, 2023, converted $10 million, or approximately 20%, of its term
loan into equity.
The Company’s third quarter 2023 financial
results are preliminary and are subject to the completion of the
review of the Company’s third quarter 2023 financial statements.
Complete third quarter 2023 financial results will be announced in
November.
Updated 2023 Financial
OutlookThe Company expects fourth quarter sepsis and
related product revenue of $2.4 million, representing a sequential
quarterly increase of 60% compared to the third quarter of 2023. As
a result of the sepsis test backorder, the Company now expects full
year total sepsis and related product revenue of $7.5 million,
representing a decline of 10% compared to 2022.
Nasdaq Listing StatusThe
Company regained compliance with Nasdaq market value of listed
securities of $35 million on July 6, 2023 and today effected a 1
for 100 reverse stock split intended to regain compliance with
Nasdaq minimum bid price rule.
Webcast and Conference Call
InformationThe Company’s management team will host a
conference call today, October 12, 2023, beginning at 4:30 pm ET.
Investors interested in listening to the call may do so by dialing
888-506-0062 for domestic callers or 973-528-0011 for International
callers and using conference ID 505931 approximately five minutes
prior to the start time. A live and recorded webcast of the call
will be available on the “Investors” section of the Company’s
website at www.t2biosystems.com.
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, the
T2Biothreat™ 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
expanded T2Bacteria Panel to add Acinetobacter baumannii, the
Candida auris test, and the T2Lyme™ Panel, as well as
next-generation products for the detection of bacterial and fungal
pathogens and associated antimicrobial resistance markers. 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 our
growth opportunities as a result of the receipt of FDA 510(k)
clearance for the T2Biothreat Panel and 510(k) submission to add
Acinetobacter baumannii detection to the FDA-cleared T2Bacteria
Panel, maintenance of our Nasdaq listing, our market opportunity,
revenue results and cash balance, financial outlook, instrument
contracts, timing of completing clinical trials and filing of an
FDA submission, 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; (iv) failure to regain and maintain
compliance with Nasdaq listing requirements and receipt of
shareholder approval at our upcoming annual meeting of a reverse
stock split; or (v) the factors discussed under Item 1A. “Risk
Factors” in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2022, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 31, 2023, 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)
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