T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2023 Financial Results
15 Febrero 2024 - 3:06PM
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 and operational results for the fourth quarter and full
year ended December 31, 2023.
Full Year 2023 and Recent Commercial
Highlights
- Achieved full year 2023 total
revenue of $7.2 million, including sepsis and related product
revenue of $6.8 million and research and contribution revenue of
$0.4 million.
- Achieved fourth quarter 2023 total
revenue of $1.7 million, comprised entirely of product revenue
including record sales of the T2Bacteria Panel in the U.S.
- Executed contracts for 26 T2Dx®
Instruments in 2023, including 19 T2Dx Instruments from outside the
U.S. and 7 T2Dx Instruments from the U.S.
- Expanded international distribution
network to include the Netherlands, Belgium, Vietnam, and the
re-entry into Switzerland.
- Eliminated sepsis test backorder as
of the end of January 2024.
Recent Pipeline and Clinical
Highlights
- Received FDA 510(k) clearance to
add the detection of Acinetobacter baumannii to the
FDA-cleared T2Bacteria Panel.
- Submitted a 510(k) premarket
notification to the U.S. FDA to expand the use of the T2Candida
Panel to include pediatric testing.
- Received Phase 2 award from the
U.S. Department of Health and Human Services and the Steven &
Alexandra Cohen Foundation’s LymeX Diagnostics Prize for the T2Lyme
Panel.
- Advanced the T2Resistance Panel
toward U.S. FDA 510(k) submission, expected to occur during the
third quarter of 2024.
- Presented new clinical data at
IDWeek 2023 demonstrating speed, accuracy, and clinical benefits of
T2Dx Instrument, T2Bacteria Panel, T2Candida Panel, and
T2Resistance Panel.
Financial and Operational
Updates
- Presented a detailed plan to Nasdaq
Listing Qualifications Hearing Panel on February 15, 2024, to
regain compliance with $35 million Market Value of Listed
Securities requirement; response expected in the coming weeks.
- Executed agreement with CRG to
convert an additional $15 million of the outstanding term loan into
shares of common stock and shares of newly designated preferred
stock (to the extent CRG’s beneficial ownership would be above
49.99% of the Company’s outstanding common stock), upon receipt of
shareholder approval.
- Amended term loan agreement with
CRG, extending the maturity date and interest-only period to
December 31, 2025, and reducing the minimum cash covenant from $5.0
million to $500,000.
- Cash and cash equivalents totaled
$15.7 million as of December 31, 2023.
“We made considerable progress across the
business during 2023, increasing our global installed base of T2Dx
Instruments, generating record U.S. sales of our T2Bacteria Panel,
strengthening our supply chain and manufacturing operations,
advancing multiple new product development initiatives, and
strengthening our balance sheet,” stated John Sperzel,
Chairman and CEO of T2 Biosystems. “We are very excited by the
progress on our new product pipeline, which includes the recent FDA
clearances for the T2Biothreat Panel and the expanded T2Bacteria
Panel to include the detection of Acinetobacter baumannii, as well
as the pending FDA clearance to expand the T2Candida Panel to
include pediatric testing. Additionally, we have three pipeline
products that have received FDA Breakthrough Device designation,
including the T2Resistance Panel, the T2Lyme Panel, and the Candida
auris test. We believe we are well-positioned heading into 2024,
and we expect to accelerate our product sales, enhance our
operations, and continue to advance out new product pipeline.”
2024 Financial Outlook The
Company expects full year 2024 total sepsis and related product
revenue of $10.0 million to $11.0 million, representing growth of
49% to 64%, compared to $6.7 million in 2023. The Company’s 2024
revenue guidance consists entirely of sepsis and related product
revenue and does not include potential sales of the T2Biothreat
Panel or the T2Lyme Panel.
Webcast and Conference Call
InformationThe Company’s management team will host a
conference call today, February 15, 2024, 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 106354 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, and the
T2Biothreat™ Panel, and are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the U.S. T2Resistance Panel, the
Candida auris test, and the T2Lyme™ Panel. 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, 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) clearance
to add Acinetobacter baumannii detection to
the FDA-cleared T2Bacteria Panel, maintenance of our Nasdaq
listing, our market opportunity, financial results, 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. The preliminary, estimated financial results for the fourth
quarter and fiscal year ended 2023 contained in this press release
contain forward-looking statements and are subject to the
completion of management’s and the audit committee’s final reviews
and our other financial closing procedures and are therefore
subject to change. You should not place undue reliance on such
preliminary information and estimates because they may prove to be
materially inaccurate. The preliminary information and estimates
have not been compiled or examined by our independent auditors and
they are subject to revision as we prepare our financial statements
as of and for the quarter ended December 31, 2023, including all
disclosures required by U.S. generally accepted accounting
principles. While we believe that such preliminary information and
estimates are based on reasonable assumptions, actual results may
vary, and such variations may be material. 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, 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
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