T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens, today announced financial
results for the three months ended March 31, 2021.
Recent Highlights
- Achieved first quarter 2021 revenue of $7.0 million, including
product revenue of $4.7 million, representing growth of 173% and
345%, respectively, compared to the prior year period
- Increased U.S. sepsis test utilization by 85% compared to the
prior year period, resulting in a first quarter annualized test run
rate of approximately $111,000 per legacy sepsis instrument
- Sold 4 T2Dx® Instruments during the first quarter, including 1
in the U.S. and 3 internationally
- Expanded U.S. salesforce to 9 Regional Account Managers
- Announced newly published independent study concluding the use
of T2 sepsis panels provides faster time to detection, faster time
to targeted therapy, and shortened length-of-stay
- Confirmed the T2SARS-CoV-2TM Panel is capable of detecting the
India B.1.617 variant of the SARS-CoV-2 virus based on sequence
alignments and in silico analysis
- Modified terms of existing BARDA contract to add T2Resistance®
Panel and accelerate development of comprehensive sepsis panel,
next generation instrument, and biothreat panel
“Entering 2021, we set three corporate priorities: accelerating
our sales, improving our operations, and advancing our pipeline. We
are very pleased with our progress during the first quarter, which
included 173% total revenue growth, 345% product revenue growth and
85% sepsis test revenue growth,” stated John Sperzel, President and
CEO of T2 Biosystems. “We have rebuilt a clinically focused U.S.
sales team to drive greater adoption of our novel sepsis products
and we are strengthening our medical and clinical affairs teams to
support our customers. We remain excited about our product
pipeline, including the T2Resistance Panel, and our opportunity to
lead the change in the standard of care for the management of
patients suspected of sepsis.”
First Quarter 2021 Financial Results Total
revenue for the first quarter of 2021 was $7.0 million, an increase
of 173% compared to the prior year period. Product revenue for the
first quarter of 2021 was $4.7 million, an increase of 345%
compared to the prior year period, driven by increased test panel
and instrument sales. Research and contribution revenue for the
first quarter of 2021 was $2.3 million, an increase of 54% compared
to the prior year period, driven by increased BARDA contract
activity.
Operating expenses for the first quarter of 2021 were $10.9
million, a decrease of $0.6 million compared to the prior year
period, driven by increased BARDA contract research and development
activity offset by lower selling, general and administrative
headcount.
Net loss for the first quarter of 2021 was $(10.7) million,
$(0.07) per share, compared to a net loss of $(14.9) million,
$(0.22) per share, in the prior year period.
Cash, equivalents, marketable securities and restricted cash
were $43.9 million as of March 31, 2021.
2021 Financial OutlookThe Company continues to
expect revenue for the full year 2021 to be between $24.0 million
and $26.0 million, including product revenue between $16.0 million
and $18.0 million and research and contribution revenue of $8.0
million. The Company continues to expect to close at least 30 T2Dx
Instrument contracts in 2021.
Webcast and Conference Call InformationT2’s
management team will host a conference call today, May 6, 2021,
beginning at 4:30pm ET. Investors interested in listening to the
call may do so by dialing 1-800-496-4125 for domestic callers or
1-856-344-9209 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, 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, T2Candida®
Panel, the T2Bacteria® 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 T2Cauris™ Panel, and T2Lyme™
Panel, as well as additional products for the detection of
bacterial and fungal pathogens and associated antimicrobial
resistance markers, and biothreat pathogens.
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, anticipated strategic
priorities, 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, 2020, filed with the U.S.
Securities and Exchange Commission, or SEC, on March 31, 2021,
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.
Media Contact:Gina Kent, Vault
Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact:Philip Trip Taylor, Gilmartin
Groupphilip@gilmartinIR.com 415-937-5406
T2 BIOSYSTEMS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (In
thousands, except share and per share data) (Unaudited)
|
March 31, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
10,691 |
|
|
$ |
16,793 |
|
Marketable securities |
|
22,617 |
|
|
|
25,396 |
|
Accounts receivable |
|
4,034 |
|
|
|
5,099 |
|
Inventories |
|
4,525 |
|
|
|
3,636 |
|
Prepaid expenses and other current assets |
|
2,720 |
|
|
|
2,660 |
|
Total current assets |
|
44,587 |
|
|
|
53,584 |
|
Property and equipment,
net |
|
4,202 |
|
|
|
3,771 |
|
Operating lease right-of-use
assets |
|
10,606 |
|
|
|
11,034 |
|
Restricted cash |
|
551 |
|
|
|
551 |
|
Marketable securities |
|
10,002 |
|
|
|
10,002 |
|
Other assets |
|
104 |
|
|
|
136 |
|
Total assets |
$ |
70,052 |
|
|
$ |
79,078 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’
(deficit) equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
3,907 |
|
|
$ |
2,058 |
|
Accrued expenses and other current liabilities |
|
6,094 |
|
|
|
7,512 |
|
Deferred revenue |
|
400 |
|
|
|
230 |
|
Total current liabilities |
|
10,401 |
|
|
|
9,800 |
|
Notes payable |
|
45,855 |
|
|
|
45,235 |
|
Operating lease liabilities,
net of current portion |
|
10,255 |
|
|
|
10,533 |
|
Deferred revenue, net of
current portion |
|
281 |
|
|
|
424 |
|
Derivative liability |
|
181 |
|
|
|
1,010 |
|
Other liabilities |
|
3,645 |
|
|
|
3,350 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’ (deficit)
equity: |
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no
shares issued and outstanding at March 31, 2021 and
December 31, 2020 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized;
148,491,673 and 148,078,974 shares issued and outstanding at
March 31, 2021 and December 31, 2020, respectively |
|
148 |
|
|
|
148 |
|
Additional paid-in capital |
|
432,905 |
|
|
|
431,544 |
|
Accumulated other comprehensive income |
|
16 |
|
|
|
9 |
|
Accumulated deficit |
|
(433,635 |
) |
|
|
(422,975 |
) |
Total stockholders’ (deficit) equity |
|
(566 |
) |
|
|
8,726 |
|
Total liabilities and
stockholders’ (deficit) equity |
$ |
70,052 |
|
|
$ |
79,078 |
|
T2 BIOSYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (In thousands, except share and per share
data) (Unaudited)
|
Three Months Ended |
|
|
March 31, |
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
Product revenue |
$ |
4,650 |
|
|
$ |
1,045 |
|
Contribution revenue |
|
2,306 |
|
|
|
1,500 |
|
Total revenue |
|
6,956 |
|
|
|
2,545 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Cost of product revenue |
|
5,790 |
|
|
|
4,671 |
|
Research and development |
|
4,665 |
|
|
|
4,780 |
|
Selling, general and administrative |
|
6,203 |
|
|
|
6,655 |
|
Total costs and expenses |
|
16,658 |
|
|
|
16,106 |
|
Loss from operations |
|
(9,702 |
) |
|
|
(13,561 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
6 |
|
|
|
— |
|
Interest expense |
|
(1,013 |
) |
|
|
(1,417 |
) |
Other income, net |
|
49 |
|
|
|
29 |
|
Total other expense |
|
(958 |
) |
|
|
(1,388 |
) |
Net loss |
$ |
(10,660 |
) |
|
$ |
(14,949 |
) |
Net loss per share — basic and
diluted |
$ |
(0.07 |
) |
|
$ |
(0.22 |
) |
Weighted-average number of
common shares used in computing |
|
|
|
|
|
|
|
net loss per share — basic and diluted |
|
148,231,412 |
|
|
|
68,637,322 |
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
Net loss |
$ |
(10,660 |
) |
|
$ |
(14,949 |
) |
Change in net unrealized gain
on marketable securities, net of taxes: |
|
|
|
|
|
|
|
Net unrealized gain on marketable securities arising during the
period |
|
9 |
|
|
|
— |
|
Less: net realized gain on marketable securities included in net
loss |
|
(2 |
) |
|
|
— |
|
Net unrealized gain on
marketable securities |
|
7 |
|
|
|
— |
|
Comprehensive loss |
$ |
(10,653 |
) |
|
$ |
(14,949 |
) |
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