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 first
quarter ended March 31, 2023.
Recent Financial and Operational
Highlights
- Achieved first quarter total
revenue of $2.1 million, including sepsis and related product
revenue of $1.7 million and research contribution revenue of $0.4
million.
- Increased sepsis panel revenue by
11% year over year, driven by increased T2Bacteria® Panel sales of
109% in the U.S. and 55% globally.
- Executed contracts for 5 T2Dx®
Instruments during the first quarter.
-
Secured multi-year pricing agreements with two large U.S. health
systems, representing a total of 69 Hospitals, for T2Dx
Instruments, T2Bacteria Panels and T2Candida® Panels.
-
Announced exploration of strategic alternatives and implemented a
restructuring program completed this past week including an
incremental workforce reduction of nearly 30%.
Recent Pipeline and Clinical
Highlights
- Filed FDA submission for
T2Biothreat™ Panel, a direct-from-blood test that runs on the
FDA-cleared T2Dx Instrument and detects six biothreat pathogens
identified as threats by the CDC.
-
Applied for FDA Breakthrough Device Designation for Candida auris,
a multidrug-resistant fungal pathogen that has been labeled as a
serious global health threat with mortality rate up to 60%.
-
Completed assay development for T2Lyme™ Panel and established
preliminary level of detection (LOD) of 2 CFU/mL.
-
Advanced U.S. clinical trial for T2Resistance® Panel, completing
nearly 90% of patient enrollment.
“In an effort to maximize value, we have engaged
an advisory firm to explore all potential strategic alternatives.
In addition, to preserve capital, decrease quarterly cash usage and
position the Company to explore strategic alternatives, we have
simultaneously implemented a restructuring program,” stated John
Sperzel, Chairman and CEO of T2 Biosystems. “In the first half of
the year, we have made very important advances in our product
pipeline, including FDA 510(k) submission for the T2Biothreat
Panel, FDA Breakthrough Device Designation application for Candida
auris, completion of assay development for the T2Lyme Panel, and
completed nearly 90% of patient enrollment in the T2Resistance
Panel U.S. clinical trial, which position us to expand our
addressable markets in the future.”
First Quarter 2023 Financial
ResultsTotal revenue for the first quarter of 2023 was
$2.1 million, a 71% decrease compared to the prior year period,
driven by a decline in COVID-19 test sales and reduced BARDA
activities. Product revenue was $1.7 million, a decrease of 57%
compared to the prior year period, driven by the expected 98%
decline in COVID-19 test sales and partially offset by increased
sepsis test sales. Research contribution revenues were $0.4
million, an 88% decrease compared to the prior year period, driven
by the level of BARDA contract activities.
Cost of product revenue for the first quarter of
2023 was $4.0 million, a 35% decrease compared to the prior year
period, driven by decreased COVID-19 test sales. Research and
development expenses were $4.5 million, a 33% decrease compared to
the prior year period, driven by decreased BARDA contract
activities. Selling, general and administrative expenses were $7.3
million, a 21% decrease compared to the prior year period driven by
decreased Medical Affairs spending.
Net loss for the first quarter of 2023 was $18.0
million, $1.32 per share, compared to a net loss of $16.5 million,
$4.86 per share, in the prior year period.
Cash and cash equivalents totaled $10.1 million
as of March 31, 2023. The Company raised $1.0 million in net
proceeds through ATM sales in the first quarter of 2023 and in
February 2023, raised $11.0 million, net through a common stock and
warrants sale. The impact of the incremental 30% workforce
reduction is expected to significantly decrease cash usage in the
subsequent quarters.
2023 Financial OutlookThe
Company reiterates its full year 2023 financial outlook and
continues to expect total sepsis and related product revenue of
$11.0 million to $13.0 million, representing growth of 31% to 55%,
compared to $8.4 million in 2022. Given the focus on product
revenue, the Company is not providing guidance on research and
contribution revenue.
Webcast and Conference Call
InformationThe Company’s management team will host a
conference call today, May 23, 2023, beginning at 8:30 am ET.
Investors interested in listening to the call may do so by dialing
877-545-0523 for domestic callers or 973-528-0016 for International
callers and using conference ID 717782 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 T2Cauris™
Panel, 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 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 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; 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
T2 BIOSYSTEMS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands, except share and per share data) |
(Unaudited) |
|
|
March 31,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,117 |
|
|
$ |
10,329 |
|
Accounts receivable |
|
|
1,323 |
|
|
|
2,163 |
|
Inventories |
|
|
4,936 |
|
|
|
4,285 |
|
Prepaid expenses and other current assets |
|
|
2,549 |
|
|
|
2,582 |
|
Total current assets |
|
|
18,925 |
|
|
|
19,359 |
|
Property and equipment, net |
|
|
4,801 |
|
|
|
4,533 |
|
Operating lease right-of-use
assets |
|
|
8,420 |
|
|
|
8,741 |
|
Restricted cash |
|
|
551 |
|
|
|
1,551 |
|
Other assets |
|
|
35 |
|
|
|
143 |
|
Total assets |
|
$ |
32,732 |
|
|
$ |
34,327 |
|
Liabilities and
stockholders’ deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,131 |
|
|
$ |
1,296 |
|
Accrued expenses and other current liabilities |
|
|
5,162 |
|
|
|
7,269 |
|
Operating lease liability |
|
|
1,415 |
|
|
|
1,352 |
|
Warrant liabilities |
|
|
7,972 |
|
|
|
39 |
|
Deferred revenue |
|
|
149 |
|
|
|
172 |
|
Total current liabilities |
|
|
17,829 |
|
|
|
10,128 |
|
Notes payable |
|
|
50,108 |
|
|
|
49,651 |
|
Operating lease liabilities, net
of current portion |
|
|
7,832 |
|
|
|
8,214 |
|
Deferred revenue, net of current
portion |
|
|
74 |
|
|
|
52 |
|
Derivative liability related to
Term Loan |
|
|
1,858 |
|
|
|
1,088 |
|
Accrued interest on term
loan |
|
|
4,917 |
|
|
|
4,849 |
|
Total liabilities |
|
|
82,618 |
|
|
|
73,982 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
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;
20,368,463 and 7,716,519 shares issued and outstanding at
March 31, 2023 and December 31, 2022, respectively |
|
|
21 |
|
|
|
8 |
|
Additional paid-in capital |
|
|
502,277 |
|
|
|
494,556 |
|
Accumulated deficit |
|
|
(552,184 |
) |
|
|
(534,219 |
) |
Total stockholders’ deficit |
|
|
(49,886 |
) |
|
|
(39,655 |
) |
Total liabilities and
stockholders’ deficit |
|
$ |
32,732 |
|
|
$ |
34,327 |
|
T2 BIOSYSTEMS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(In thousands, except share and per share data) |
(Unaudited) |
|
|
Three Months
EndedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
Product revenue |
|
$ |
1,655 |
|
|
$ |
3,844 |
|
Contribution revenue |
|
|
423 |
|
|
|
3,390 |
|
Total revenue |
|
|
2,078 |
|
|
|
7,234 |
|
Costs and expenses: |
|
|
|
|
|
|
Cost of product revenue |
|
|
3,995 |
|
|
|
6,205 |
|
Research and development |
|
|
4,471 |
|
|
|
6,656 |
|
Selling, general and administrative |
|
|
7,299 |
|
|
|
9,230 |
|
Total costs and expenses |
|
|
15,765 |
|
|
|
22,091 |
|
Loss from operations |
|
|
(13,687 |
) |
|
|
(14,857 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest income |
|
|
2 |
|
|
|
3 |
|
Interest expense |
|
|
(1,522 |
) |
|
|
(1,650 |
) |
Change in fair value of derivative related to Term Loan |
|
|
(770 |
) |
|
|
— |
|
Change in fair value of warrant liabilities |
|
|
(1,304 |
) |
|
|
— |
|
Other income |
|
|
— |
|
|
|
11 |
|
Other expense |
|
|
(682 |
) |
|
|
— |
|
Other losses |
|
|
(2 |
) |
|
|
(2 |
) |
Total other expense |
|
|
(4,278 |
) |
|
|
(1,638 |
) |
Net loss and comprehensive
loss |
|
$ |
(17,965 |
) |
|
$ |
(16,495 |
) |
Net loss per share — basic and
diluted |
|
$ |
(1.32 |
) |
|
$ |
(4.86 |
) |
Weighted-average number of common
shares used in computing net loss per share — basic and
diluted |
|
|
13,633,352 |
|
|
|
3,397,103 |
|
T2 Biosystems (NASDAQ:TTOO)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
T2 Biosystems (NASDAQ:TTOO)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024