T2 Biosystems Announces First Quarter 2024 Financial Results
07 5월 2024 - 5:34AM
T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in
the rapid detection of sepsis-causing pathogens and antibiotic
resistance genes, today announced unaudited financial and
operational results for the first quarter ended March 31, 2024.
Recent Financial and Operational
Highlights
- Achieved first quarter 2024 sepsis
product revenue of $2.1 million, representing growth of 25%
compared to the prior year period and sequential growth of 23%
compared to the fourth quarter of 2023, led by T2Candida Panel
sales and strong T2Resistance Panel sales internationally.
- Executed contracts for 8 T2Dx®
Instruments during the first quarter, including 5 T2Dx Instruments
from outside the U.S. and 3 T2Dx Instruments from the U.S.
- Strengthened balance sheet by
converting $30.0 million of term loan debt with CRG Servicing LLC
(“CRG”) in exchange for shares of T2 Biosystems equity, reducing
both total debt and quarterly interest payments to CRG by
approximately 80% percent from the balance as of May of 2023.
- Extended multi-year capital
equipment supplier agreement with Vizient, Inc., the largest
member-driven health care performance improvement company in the
U.S., through March 31, 2025.
- Signed an international
distribution agreement in Qatar to further expand commercialization
in the Middle East.
- Cash and cash equivalents totaled
$6.2 million as of March 31, 2024.
Recent Pipeline and Clinical
Highlights
- Received FDA 510(k) clearance for
the expanded T2Bacteria Panel to include the detection of
Acinetobacter baumannii.
- Advanced discussions with potential
LDT partners to initiate commercialization the T2Lyme Panel in the
third quarter of 2024 as a laboratory developed test (LDT).
- Submitted a 510(k) premarket
notification to the U.S. FDA to expand the use of the T2Candida
Panel to include pediatric testing.
- Advanced the T2Resistance Panel
toward U.S. FDA 510(k) submission, expected to occur during the
third quarter of 2024.
- Engaged Dr. Robin Robinson, former Director of BARDA and former
Deputy Assistant Secretary for ASPR, as a strategic advisor to aid
in commercialization of the T2Biothreat Panel.
- Real-world use of the T2Resistance
Panel in the EU published in the Journal of Clinical Microbiology,
demonstrated the T2Resistance Panel’s high sensitivity and
specificity, reductions in the time to detect resistance by
approximately 90% compared to standard methodology and positive
impacts to clinical decisions for antimicrobial therapy.
- New data presented at the ECCMID
2024 conference found improved patient outcomes with T2Candida
compared to conventional blood culture testing and the ability for
T2Bacteria to detect persistent S. aureus infections better than
blood culture.
“We believe T2 Biosystems has reached an
inflection point, having achieved double digit sepsis product sales
growth in the first quarter, made significant advances across the
product pipeline that we anticipate will drive further growth in
2024, and transformed the Company’s balance sheet to better support
the continued advancement of our corporate priorities,”
stated John Sperzel, Chairman and CEO of T2 Biosystems.
“Looking ahead, we plan to launch T2Lyme Panel and file the FDA
submission for the T2Resistance Panel during the third quarter of
2024. We are extremely excited about the future of T2Biosystems and
believe the Company is well positioned for growth.”
First Quarter 2024 Financial
ResultsSepsis product revenue for the first quarter of
2024 was $2.1 million, representing a 25% increase compared to the
prior year period, led by T2Candida Panel sales and strong
T2Resistance Panel sales internationally.
Cost of product revenue for the first quarter of
2024 was $4.2 million, a 5% increase compared to the prior year
period driven by increased sales volume. Research and development
expenses were $3.7 million, a 17% decrease compared to the prior
year period, driven by decreased BARDA contract activities.
Selling, general and administrative expenses were $6.7 million, an
8% decrease compared to the prior year period driven by decreased
headcount.
Net loss for the first quarter of 2024 was $13.5
million, $2.66 per share, compared to a net loss of $18.0 million,
or $131.77 per share, in the prior year period.
Cash and cash equivalents totaled $6.2 million
as of March 31, 2024, compared to $15.7 million as of December 31,
2023. The Company raised $2.2 million in net proceeds through ATM
sales in the first quarter of 2024. In the past 12 months the
Company has reduced its total outstanding indebtedness from $50.5
million to $10.5 million as of May 6, 2024, a 79% reduction.
Reiterated 2024 Financial
OutlookThe Company continues to expect full year 2024
total sepsis 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 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, May 6, 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 160751 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 the
likelihood that commercialization of the T2Lyme Panel will occur in
the third quarter of 2024, the ability of the Company to provide
T2Lyme results to U.S. reference laboratories nationwide, the
Company’s ability to expand the use of the T2Candida Panel to
include pediatric testing, the timeline for the U.S. FDA 510(k)
submission for the T2Resistance Panel in the third quarter of 2024,
management’s expectations for future growth of the Company, the
likelihood that the growing dataset for T2Resistance will be a
catalyst for increased adoption in countries where the T2Resistance
Panel is currently available for purchase, and , 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; (i) continue as a
going concern; 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, 2023,
filed with the U.S. Securities and Exchange Commission, or SEC, on
April 1, 2024, 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.Consolidated Balance
Sheets(In thousands, except share and per share
data)(Unaudited) |
|
|
|
March 31,2024 |
|
|
December 31,2023 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,208 |
|
|
$ |
15,689 |
|
Accounts receivable, net |
|
|
1,588 |
|
|
|
1,420 |
|
Inventories |
|
|
4,670 |
|
|
|
4,819 |
|
Prepaid expenses and other current assets |
|
|
3,094 |
|
|
|
3,261 |
|
Total current assets |
|
|
15,560 |
|
|
|
25,189 |
|
Property and equipment,
net |
|
|
1,611 |
|
|
|
1,658 |
|
Operating lease right-of-use
assets |
|
|
7,031 |
|
|
|
7,395 |
|
Restricted cash |
|
|
551 |
|
|
|
551 |
|
Other assets |
|
|
2 |
|
|
|
4 |
|
Total assets |
|
$ |
24,755 |
|
|
$ |
34,797 |
|
Liabilities and
stockholders’ deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Notes payable to related party |
|
$ |
41,666 |
|
|
$ |
41,284 |
|
Accounts payable |
|
|
1,887 |
|
|
|
1,527 |
|
Accrued expenses and other current liabilities |
|
|
4,231 |
|
|
|
4,905 |
|
Accrued final payment fee on Term Loan with related party |
|
|
4,767 |
|
|
|
4,807 |
|
Operating lease liability |
|
|
1,651 |
|
|
|
1,616 |
|
Derivative liability related to Term Loan with related party |
|
|
1,662 |
|
|
|
1,554 |
|
Warrant liabilities |
|
|
207 |
|
|
|
235 |
|
Deferred revenue |
|
|
185 |
|
|
|
224 |
|
Total current liabilities |
|
|
56,256 |
|
|
|
56,152 |
|
Operating lease liabilities,
net of current portion |
|
|
6,180 |
|
|
|
6,598 |
|
Deferred revenue, net of
current portion |
|
|
92 |
|
|
|
83 |
|
Total liabilities |
|
|
62,528 |
|
|
|
62,833 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ deficit |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized:
Series B Convertible Preferred Stock, 10,875 shares designated on
March 31, 2024, 10,875 and 93,297 shares issued and outstanding on
March 31, 2024 and December 31, 2023, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 400,000,000 shares authorized;
5,512,332 and 4,058,381 shares issued and outstanding on
March 31, 2024 and December 31, 2023, respectively |
|
|
6 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
560,051 |
|
|
|
556,256 |
|
Accumulated deficit |
|
|
(597,830 |
) |
|
|
(584,296 |
) |
Total stockholders’ deficit |
|
|
(37,773 |
) |
|
|
(28,036 |
) |
Total liabilities and
stockholders’ deficit |
|
$ |
24,755 |
|
|
$ |
34,797 |
|
|
T2 Biosystems, Inc.Consolidated Statements
of Operations and Comprehensive Loss(In thousands,
except share and per share
data)(Unaudited) |
|
|
|
Three Months
EndedMarch 31, |
|
|
|
2024 |
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
Product revenue |
|
$ |
2,061 |
|
|
$ |
1,655 |
|
Contribution revenue |
|
|
— |
|
|
|
423 |
|
Total revenue |
|
|
2,061 |
|
|
|
2,078 |
|
Costs and expenses: |
|
|
|
|
|
|
Cost of product revenue |
|
|
4,202 |
|
|
|
3,995 |
|
Research and development |
|
|
3,721 |
|
|
|
4,471 |
|
Selling, general and administrative |
|
|
6,738 |
|
|
|
7,299 |
|
Total costs and expenses |
|
|
14,661 |
|
|
|
15,765 |
|
Loss from operations |
|
|
(12,600 |
) |
|
|
(13,687 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest expense to related party |
|
|
(1,179 |
) |
|
|
(1,522 |
) |
Change in fair value of derivative related to Term Loan with
related party |
|
|
(108 |
) |
|
|
(770 |
) |
Change in fair value of warrant liabilities |
|
|
28 |
|
|
|
(1,304 |
) |
Other, net |
|
|
325 |
|
|
|
(682 |
) |
Total other income
(expense) |
|
|
(934 |
) |
|
|
(4,278 |
) |
Net loss |
|
$ |
(13,534 |
) |
|
$ |
(17,965 |
) |
Net loss per share — basic and
diluted |
|
$ |
(2.66 |
) |
|
$ |
(131.77 |
) |
Weighted-average number of
common shares used in computing net loss per share — basic and
diluted |
|
|
5,094,809 |
|
|
|
136,333 |
|
|
|
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(13,534 |
) |
|
$ |
(17,965 |
) |
Total other comprehensive
income, net of taxes |
|
|
— |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(13,534 |
) |
|
$ |
(17,965 |
) |
T2 Biosystems (NASDAQ:TTOO)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
T2 Biosystems (NASDAQ:TTOO)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024