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 third
quarter ended September 30, 2022.
Recent Commercial and Financial
Highlights
- Achieved third quarter total
revenue of $3.7 million, including product revenue of $2.6
million.
- Achieved sepsis and related revenue
(non-COVID product revenue) of $2.4 million, representing a record
number for a single quarter and an increase of 24% compared to the
prior year period.
- Executed contracts for 11 T2Dx®
Instruments during the third quarter, including 3 in the U.S. and 8
outside the U.S., increasing the totals through the first nine
months of 2022, to 20 in the U.S. and 18 internationally.
- Amended term loan agreement with
CRG, extending both the interest-only period and the maturity date
to December 30, 2024
Recent Pipeline and Clinical
Highlights
- Completed all milestones for Option
2B of the multiple-year product development contract with BARDA and
received Option 3 of the contract, valued at $3.7 million, to
finalize U.S. clinical trials and complete FDA submission for the
T2Biothreat™ Panel and the T2Resistance® Panel.
- Announced plans to complete the
development of and commercialize the T2Lyme Panel, recently awarded
FDA Breakthrough Device Designation, with the goal to initiate
marketing and sales in the U.S. as a Laboratory Developed Test in
2023.
- Received Phase 1 LymeX Diagnostics
prize from U.S. Department of Health and Human Services (HHS) and
Steven & Alexandra Cohen Foundation to advance the T2Lyme
Panel.
- Initiated studies to expand the
T2Bacteria® Panel to include detection of Acinetobacter baumannii,
the tenth most common pathogen that has a crude ICU mortality rate
of 34.0% to 43.4%.
- Announced publication of three peer
review studies conducted in Europe in the Journal of Clinical
Microbiology, Microbiology Spectrum and the Journal of Fungi
demonstrating the clinical value of T2’s Biosystems’ sepsis
products for improved rapid detection.
“During the third quarter, the T2 Biosystems
team generated a quarterly record of $2.4 million of sepsis and
related product revenue. We are very excited by the progress with
our near-term product pipeline, including the T2Biothreat,
T2Resistance, T2Lyme, and expanded T2Bacteria panels. Each new
product represents a differentiated solution to rapidly identify
harmful pathogens and allow clinicians to achieve faster targeted
therapy,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
“To close the year, we will remain focused on our three corporate
priorities, accelerating our sales, enhancing our operations, and
advancing our pipeline to support long term growth and sustained
value creation.”
Third Quarter 2022 Financial
ResultsTotal revenue for the third quarter of 2022 was
$3.7 million, including product revenue of $2.6 million,
representing decreases of 50% and 39% respectively, compared to the
prior year period, primarily driven by an 88% decline in sales of
COVID-19 tests from $2.4 million and reduced BARDA revenue offset
by increased sepsis test sales. Research contribution revenue for
the third quarter of 2022 was $1.0 million, a decrease of 67%
compared to the prior year period primarily due to extensions
required to increase enrollment in the T2Resistance trial.
Research and development expenses were $6.4
million, flat compared to the prior year period. Selling, general
and administrative expenses were $7.0 million, a decrease of $1.5
million compared to the prior year period driven by reduced medical
affairs expenses.
Net loss for the third quarter of 2022 was $17.4
million, $2.95 per share, compared to a net loss of $14.0 million,
$4.21 per share, in the prior year period.
Cash, cash equivalents and restricted cash were
$21.5 million as of September 30, 2022 and cash provided by the ATM
was $22.9 million.
2022 Financial OutlookThe
Company expects full year 2022 total revenue of $22.0 to $23.0
million, including product revenue of $11.5 to $12.0 million and
research contribution revenue of $10.5 to $11.0 million. The
Company expects to close 50 to 55 T2Dx Instrument contracts in
2022.
Webcast and Conference Call
InformationThe Company’s management team will host a
conference call today, November 10, 2022, beginning at 4:30 pm ET.
Investors interested in listening to the call may do so by dialing
888-272-8703 for domestic callers or 832-553-1663 for International
callers. 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 filing of an FDA submission, impact of
operating expense reductions, plans to develop a diagnostic test
for monkeypox, 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, 2021, filed
with the U.S. Securities and Exchange Commission, or SEC, on March
23, 2022, 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)
|
|
|
|
|
|
|
September 30,2022 |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
20,366 |
|
|
$ |
22,245 |
|
Marketable securities |
|
— |
|
|
|
9,996 |
|
Accounts receivable |
|
1,578 |
|
|
|
5,134 |
|
Inventories |
|
4,242 |
|
|
|
3,909 |
|
Prepaid expenses and other current assets |
|
2,690 |
|
|
|
3,110 |
|
Total current assets |
|
28,876 |
|
|
|
44,394 |
|
Property and equipment, net |
|
4,734 |
|
|
|
4,675 |
|
Operating lease right-of-use
assets |
|
9,058 |
|
|
|
9,766 |
|
Restricted cash |
|
1,131 |
|
|
|
1,551 |
|
Other assets |
|
153 |
|
|
|
153 |
|
Total assets |
$ |
43,952 |
|
|
$ |
60,539 |
|
Liabilities, Series A
convertible redeemable preferred stock and stockholders’
deficit |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
2,063 |
|
|
$ |
2,832 |
|
Accrued expenses and other current liabilities |
|
8,531 |
|
|
|
8,338 |
|
Derivative warrant liability |
|
186 |
|
|
|
— |
|
Deferred revenue |
|
163 |
|
|
|
518 |
|
Total current liabilities |
|
10,943 |
|
|
|
11,688 |
|
Notes payable |
|
49,188 |
|
|
|
47,790 |
|
Operating lease liabilities, net
of current portion |
|
8,569 |
|
|
|
9,359 |
|
Deferred revenue, net of current
portion |
|
8 |
|
|
|
28 |
|
Derivative liability |
|
1,792 |
|
|
|
— |
|
Other liabilities |
|
4,791 |
|
|
|
4,577 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A convertible redeemable
preferred stock; $0.001 par value; 3,000 shares designated; 3,000
shares issued and outstanding at September 30, 2022; liquidation
value of $330,000; 0 shares issued and outstanding at December 31,
2021 |
330 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Stockholders’ deficit |
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no
shares issued and outstanding at September 30, 2022 and
December 31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 400,000,000 shares authorized;
7,050,854 and 3,328,017 shares issued and outstanding at
September 30, 2022 and December 31, 2021,
respectively |
|
7 |
|
|
|
3 |
|
Additional paid-in capital |
|
492,444 |
|
|
|
459,314 |
|
Accumulated other comprehensive loss |
|
— |
|
|
|
(4 |
) |
Accumulated deficit |
|
(524,120 |
) |
|
|
(472,216 |
) |
Total stockholders’ deficit |
|
(31,669 |
) |
|
|
(12,903 |
) |
Total liabilities, Series A
convertible redeemable preferred stock and stockholders’
deficit |
$ |
43,952 |
|
|
$ |
60,539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
T2 BIOSYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (In thousands, except share and per share
data) (Unaudited)
|
|
|
|
|
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
$ |
2,641 |
|
|
$ |
4,306 |
|
|
$ |
9,044 |
|
|
$ |
12,634 |
|
Contribution revenue |
|
1,036 |
|
|
|
3,122 |
|
|
|
7,778 |
|
|
|
8,444 |
|
Total revenue |
|
3,677 |
|
|
|
7,428 |
|
|
|
16,822 |
|
|
|
21,078 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
6,085 |
|
|
|
4,720 |
|
|
|
17,371 |
|
|
|
15,341 |
|
Research and development |
|
6,375 |
|
|
|
6,384 |
|
|
|
21,056 |
|
|
|
16,448 |
|
Selling, general and administrative |
|
7,017 |
|
|
|
8,536 |
|
|
|
24,071 |
|
|
|
21,983 |
|
Total costs and expenses |
|
19,477 |
|
|
|
19,640 |
|
|
|
62,498 |
|
|
|
53,772 |
|
Loss from operations |
|
(15,800 |
) |
|
|
(12,212 |
) |
|
|
(45,676 |
) |
|
|
(32,694 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
1 |
|
|
|
6 |
|
|
|
6 |
|
|
|
18 |
|
Interest expense |
|
(1,560 |
) |
|
|
(1,919 |
) |
|
|
(4,556 |
) |
|
|
(5,642 |
) |
Change in fair value of derivative instrument |
|
(117 |
) |
|
|
— |
|
|
|
(1,792 |
) |
|
|
1,010 |
|
Change in fair value of derivative warrant liability |
|
179 |
|
|
|
— |
|
|
|
179 |
|
|
|
— |
|
Other income, net |
|
(78 |
) |
|
|
163 |
|
|
|
(65 |
) |
|
|
211 |
|
Total other expense |
|
(1,575 |
) |
|
|
(1,750 |
) |
|
|
(6,228 |
) |
|
|
(4,403 |
) |
Net loss |
$ |
(17,375 |
) |
|
$ |
(13,962 |
) |
|
$ |
(51,904 |
) |
|
$ |
(37,097 |
) |
Deemed dividend on Series A
redeemable convertible preferred stock |
$ |
(330 |
) |
|
$ |
— |
|
|
$ |
(330 |
) |
|
$ |
— |
|
Net loss attributable to common
stockholders |
$ |
(17,705 |
) |
|
$ |
(13,962 |
) |
|
$ |
(52,234 |
) |
|
$ |
(37,097 |
) |
Net loss per share — basic and
diluted |
$ |
(2.95 |
) |
|
$ |
(4.21 |
) |
|
$ |
(12.08 |
) |
|
$ |
(11.86 |
) |
Weighted-average number of common
shares used in computing net loss per share — basic and
diluted |
|
6,008,819 |
|
|
|
3,317,646 |
|
|
|
4,323,452 |
|
|
|
3,127,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(17,375 |
) |
|
$ |
(13,962 |
) |
|
$ |
(51,904 |
) |
|
$ |
(37,097 |
) |
Net unrealized gain on marketable securities arising during the
period |
|
— |
|
|
|
— |
|
|
|
2 |
|
|
|
9 |
|
Net realized (gain) loss on marketable securities included in net
loss |
|
— |
|
|
|
— |
|
|
|
2 |
|
|
|
(14 |
) |
Total other comprehensive (loss)
income, net of taxes |
|
— |
|
|
|
— |
|
|
|
4 |
|
|
|
(5 |
) |
Comprehensive loss |
$ |
(17,375 |
) |
|
$ |
(13,962 |
) |
|
$ |
(51,900 |
) |
|
$ |
(37,102 |
) |
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