T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in
the rapid detection of sepsis-causing pathogens and antibiotic
resistance genes, today announced financial results for the second
quarter ended June 30, 2023.
Recent Financial and Operational
Highlights
- Achieved second quarter total revenue of $2.0 million, a
decrease of 67% compared to the prior year period primarily due to
a $3.4 million reduction in BARDA research contribution
revenues.
- Achieved sepsis test panel revenue
of $1.3 million, representing an increase of 7% compared to the
prior year period, despite ending the quarter with a $350 thousand
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.
- Strengthened balance sheet by converting $10.0 million, or
approximately 20%, of term loan debt with CRG Servicing LLC (“CRG”)
in exchange for shares of T2 Biosystems equity.
- Cash and cash equivalents totaled $16.1 million as of June 30,
2023, and the Company raised an additional $10.9 million in net
proceeds through ATM sales during the third quarter.
- Received extension to comply with Nasdaq listing requirements
through November 20, 2023.
Recent Pipeline and Clinical
Highlights
- Received FDA Breakthrough Device
designation for Candida auris direct-from-blood molecular
diagnostic test, marking the third T2 Biosystems’ product to
receive this designation.
- 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.
- Established a clinical
collaboration with Vanderbilt University Medical Center to
implement the T2Bacteria Panel and assess its impact on antibiotic
usage and clinical interventions.
“Our second quarter results were highlighted by
record quarterly sepsis test panel orders and the second largest
sepsis-driven instrument order in company history, demonstrating
increasing demand for our life-saving direct-from-whole blood
sepsis pathogen detection products,” stated John Sperzel, Chairman
and CEO of T2 Biosystems. “Progressing each of our corporate
priorities, the implementation of our strategic restructuring
program, which has led to a reduction in operating costs and the
strengthening of the balance sheet, positions T2 Biosystems to
continue the exploration of strategic alternatives and execute on
our product development and growth initiatives.”
Second Quarter 2023 Financial
ResultsTotal revenue for the second quarter of 2023 was
$2.0 million, a 67% decrease compared to the prior year period,
driven primarily by reduced BARDA contribution revenues and de
minimus COVID-19 test sales. Product revenue was $2.0 million, a
decrease of 23% compared to the prior year period, driven by the
decline in COVID-19 test sales and partially offset by increased
sepsis test sales.
Cost of product revenue for the second quarter
of 2023 was $4.9 million, a 4% decrease compared to the prior year
period, driven by decreased COVID-19 test sales. Research and
development expenses were $3.9 million, a 52% decrease compared to
the prior year period, driven by decreased BARDA contract
activities. Selling, general and administrative expenses were $6.3
million, a 20% decrease compared to the prior year period driven by
decreased Medical Affairs spending.
Net loss for the second quarter of 2023 was $6.3
million, $0.08 per share, compared to a net loss of $18.0 million,
$5.10 per share, in the prior year period.
Cash and cash equivalents totaled $16.1 million
as of June 30, 2023. The Company raised $18.5 million in net
proceeds through ATM sales in the second quarter of 2023 and on
July 6, 2023, converted $10 million, or approximately 20%, of its
term loan into equity.
Updated 2023 Financial
OutlookThe Company now expects full year total sepsis and
related product revenue of $9.5 million to $10.5 million,
representing growth of 13% to 25%, compared to 2022.
Webcast and Conference Call
InformationThe Company’s management team will host a
conference call today, August 7, 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 420267 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
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 Candida
auris test, and 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
revenue results and cash balance, financial outlook, instrument
contracts, timing of completing clinical trials and filing of an
FDA submission, impact of operating expense reductions, 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; (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, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (In
thousands, except share and per share data) (Unaudited)
|
|
June 30,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,084 |
|
|
$ |
10,329 |
|
Accounts receivable |
|
|
1,349 |
|
|
|
2,163 |
|
Inventories |
|
|
4,337 |
|
|
|
4,285 |
|
Prepaid expenses and other current assets |
|
|
2,100 |
|
|
|
2,582 |
|
Total current assets |
|
|
23,870 |
|
|
|
19,359 |
|
Property and equipment, net |
|
|
4,572 |
|
|
|
4,533 |
|
Operating lease right-of-use
assets |
|
|
8,088 |
|
|
|
8,741 |
|
Restricted cash |
|
|
551 |
|
|
|
1,551 |
|
Other assets |
|
|
49 |
|
|
|
143 |
|
Total assets |
|
$ |
37,130 |
|
|
$ |
34,327 |
|
Liabilities and
stockholders’ deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Notes payable |
|
$ |
50,571 |
|
|
$ |
49,651 |
|
Accounts payable |
|
|
2,234 |
|
|
|
1,296 |
|
Accrued expenses and other current liabilities |
|
|
10,400 |
|
|
|
7,269 |
|
Operating lease liability |
|
|
1,480 |
|
|
|
1,352 |
|
Derivative liability related to Term Loan |
|
|
836 |
|
|
|
— |
|
Warrant liabilities |
|
|
270 |
|
|
|
39 |
|
Deferred revenue |
|
|
265 |
|
|
|
172 |
|
Total current liabilities |
|
|
66,056 |
|
|
|
59,779 |
|
Operating lease liabilities, net
of current portion |
|
|
7,433 |
|
|
|
8,214 |
|
Deferred revenue, net of current
portion |
|
|
64 |
|
|
|
52 |
|
Derivative liability related to
Term Loan, net of current portion |
|
|
— |
|
|
|
1,088 |
|
Accrued interest on term
loan |
|
|
— |
|
|
|
4,849 |
|
Total liabilities |
|
|
73,553 |
|
|
|
73,982 |
|
Commitments and contingencies
(see Note 13) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ deficit |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no
shares issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 400,000,000 shares authorized;
241,849,922 and 7,716,519 shares issued and outstanding at
June 30, 2023 and December 31, 2022, respectively |
|
|
242 |
|
|
|
8 |
|
Additional paid-in capital |
|
|
521,866 |
|
|
|
494,556 |
|
Accumulated deficit |
|
|
(558,531 |
) |
|
|
(534,219 |
) |
Total stockholders’ deficit |
|
|
(36,423 |
) |
|
|
(39,655 |
) |
Total liabilities and
stockholders’ deficit |
|
$ |
37,130 |
|
|
$ |
34,327 |
|
|
T2 BIOSYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (In thousands, except share and per share
data) (Unaudited)
|
|
Three Months
EndedJune 30, |
|
|
Six Months
EndedJune 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
1,964 |
|
|
$ |
2,559 |
|
|
$ |
3,619 |
|
|
$ |
6,403 |
|
Contribution revenue |
|
|
— |
|
|
|
3,352 |
|
|
|
423 |
|
|
|
6,742 |
|
Total revenue |
|
|
1,964 |
|
|
|
5,911 |
|
|
|
4,042 |
|
|
|
13,145 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
4,869 |
|
|
|
5,081 |
|
|
|
8,864 |
|
|
|
11,286 |
|
Research and development |
|
|
3,850 |
|
|
|
8,025 |
|
|
|
8,321 |
|
|
|
14,681 |
|
Selling, general and administrative |
|
|
6,296 |
|
|
|
7,824 |
|
|
|
13,595 |
|
|
|
17,054 |
|
Total costs and expenses |
|
|
15,015 |
|
|
|
20,930 |
|
|
|
30,780 |
|
|
|
43,021 |
|
Loss from operations |
|
|
(13,051 |
) |
|
|
(15,019 |
) |
|
|
(26,738 |
) |
|
|
(29,876 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2 |
|
|
|
2 |
|
|
|
4 |
|
|
|
5 |
|
Interest expense |
|
|
(1,541 |
) |
|
|
(1,346 |
) |
|
|
(3,063 |
) |
|
|
(2,996 |
) |
Change in fair value of derivative related to Term Loan |
|
|
1,022 |
|
|
|
(1,675 |
) |
|
|
252 |
|
|
|
(1,675 |
) |
Change in fair value of warrant liabilities |
|
|
7,192 |
|
|
|
— |
|
|
|
5,888 |
|
|
|
— |
|
Other income |
|
|
37 |
|
|
|
4 |
|
|
|
37 |
|
|
|
13 |
|
Other expense |
|
|
— |
|
|
|
— |
|
|
|
(682 |
) |
|
|
— |
|
Other losses |
|
|
(8 |
) |
|
|
— |
|
|
|
(10 |
) |
|
|
— |
|
Total other income (expense) |
|
|
6,704 |
|
|
|
(3,015 |
) |
|
|
2,426 |
|
|
|
(4,653 |
) |
Net loss |
|
$ |
(6,347 |
) |
|
$ |
(18,034 |
) |
|
$ |
(24,312 |
) |
|
$ |
(34,529 |
) |
Net loss per share — basic and
diluted |
|
$ |
(0.08 |
) |
|
$ |
(5.10 |
) |
|
$ |
(0.51 |
) |
|
$ |
(9.96 |
) |
Weighted-average number of common
shares used in computing net loss per share — basic and
diluted |
|
|
80,916,888 |
|
|
|
3,535,763 |
|
|
|
47,460,986 |
|
|
|
3,466,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,347 |
) |
|
$ |
(18,034 |
) |
|
$ |
(24,312 |
) |
|
$ |
(34,529 |
) |
Net unrealized gain on marketable securities arising during the
period |
|
|
— |
|
|
|
9 |
|
|
|
— |
|
|
|
2 |
|
Net realized loss on marketable securities included in net
loss |
|
|
— |
|
|
|
2 |
|
|
|
— |
|
|
|
2 |
|
Total other comprehensive income,
net of taxes |
|
|
— |
|
|
|
11 |
|
|
|
— |
|
|
|
4 |
|
Comprehensive loss |
|
$ |
(6,347 |
) |
|
$ |
(18,023 |
) |
|
$ |
(24,312 |
) |
|
$ |
(34,525 |
) |
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