T2 Biosystems Announces Preliminary Second Quarter 2023 Financial Results
12 Julho 2023 - 9:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection
of sepsis-causing pathogens and antibiotic resistance genes, today
announced preliminary unaudited financial and operational results
for the second quarter 2023.
Recent Financial and Operational
Highlights (unaudited)
- Achieved second quarter total
revenue of $2.0 million, comprised entirely of product
revenue.
- Achieved sepsis test panel revenue
of $1.3 million, representing an increase of 7% compared to the
prior year period, despite ending the second quarter with a $0.4
million sepsis test backorder.
- Executed contracts for 11 T2Dx®
Instruments during the second quarter, including 4 in the U.S. and
7 internationally.
- Secured multi-year contract with a
European distributor for 7 T2Dx Instruments and sepsis test panels
for Poland – including T2Bacteria® Panel, T2Candida® Panel, and
T2Resistance® Panel.
- Implemented a restructuring program
in May 2023, including a workforce reduction of nearly 30%.
- Strengthened balance sheet by
converting $10.0 million, or approximately 20%, of term loan debt
with CRG Servicing LLC (“CRG”) in exchange for 48,345,798 shares of
T2 Biosystems common stock and Series B Convertible Preferred Stock
convertible into 93,297,259 shares of common stock.
- Completed Nasdaq listing compliance
hearing and a response is expected within 30 days.
- Cash and cash equivalents totaled
$16.1 million as of June 30, 2023, including $18.5 million of net
proceeds from the sale of shares through the ATM facility in the
second quarter.
Recent Pipeline and Clinical
Highlights
- Completed patient enrollment in the
U.S. clinical trial for the T2Resistance Panel.
- Filed FDA submission for
T2Biothreat™ Panel, a direct-from-blood diagnostic test that runs
on the FDA-cleared T2Dx Instrument and detects six biothreat
pathogens identified as threats by CDC.
- Submitted for FDA Breakthrough
Device Designation for a direct-from-blood diagnostic test to
detect Candida auris, a multidrug-resistant fungal pathogen
identified by CDC as an urgent threat.
- Established a clinical
collaboration with Vanderbilt University Medical Center to
implement the T2Bacteria Panel and assess its impact on antibiotic
usage and clinical interventions.
“We achieved a number of significant milestones
during the second quarter, including record demand for our sepsis
test panels, the second largest sepsis-driven instrument order in
company history, the FDA 510(k) submission for the T2Biothreat
Panel, and the FDA Breakthrough Device Designation application for
our Candida auris test,” stated John Sperzel, Chairman and CEO
of T2 Biosystems. “In addition, we recently strengthened our
balance sheet through sales of common stock and the conversion of
$10 million of debt to equity, extending our cash runway to pursue
strategic initiatives.”
The Company’s second quarter 2023 financial
results are preliminary and are subject to the completion of the
audit of the Company’s second quarter 2023 financial statements.
Complete second quarter 2023 financial results will be announced in
August.
2023 Financial Outlook
The Company now expects full year 2023 total
sepsis and related product revenue of $9.5
million to $10.5 million, representing growth of 13% to
25%, compared to $8.4 million 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 Company’s proprietary T2
Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active
pipeline of future products, including the Candida auris test, the
T2Lyme™ Panel, the T2Biothreat™ Panel, as well as additional
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, cost
improvement measures, timing of completion of clinical trials,
anticipated strategic priorities, status of product development
pipeline, product demand, commitments or opportunities, and growth
expectations or targets, as well as statements that include the
words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”,
“estimate,” “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, 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. 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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