T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens, today announced financial
results for the third quarter ended September 30, 2020.
Recent Highlights
- Achieved record quarterly revenue of $5.2 million, including
product revenue of $3.8 million, representing growth of 213% and
219% respectively, compared to the prior year period
- Sold record 32 T2Dx® Instruments in the third quarter,
including 28 instruments in the U.S., an increase of 167% compared
to the prior year period
- Increased T2Bacteria® and T2Candida® Panel revenue by 70% and
38% respectively, compared to the prior year, demonstrating
significant growth in the sepsis portfolio
- Received Emergency Use Authorization (EUA) for the
T2SARS-CoV-2® Panel molecular diagnostic test run on the
FDA-cleared T2Dx Instrument to detect the virus responsible for
COVID-19
- Completed all milestones in the base phase of the product
development contract awarded by BARDA, leading to the subsequent
exercise of the first contract option valued at $10.5 million
- Received New Technology Add-on Payment (NTAP) extension for the
T2Bacteria Panel from the U.S. Centers for Medicare & Medicaid
Services (CMS) for fiscal year 2021
“The third quarter was transformational for T2 Biosystems as we
continue our growth as a commercially driven, customer-focused
company. We achieved record sales during the quarter, grew our U.S.
installed base of T2Dx Instruments by nearly 70 percent, saw strong
demand at U.S. hospitals for our COVID-19 diagnostic test, and have
commitments from new customers to adopt our products that have
positioned us for long-term success,” stated John Sperzel,
President and CEO of T2 Biosystems. “We remain committed to our
three corporate priorities – accelerating sales, improving
operations, and advancing our pipeline – and look to build on our
momentum during the fourth quarter of 2020.”
Third Quarter 2020 Financial Results Total
revenue for the third quarter of 2020 was $5.2 million, an increase
of 213% compared to the prior year period. Product revenue for the
third quarter of 2020 was $3.8 million, an increase of 219%
compared to the prior year period, driven by increased test panel
and instrument sales. Research and contribution revenue for the
third quarter of 2020 was $1.5 million, an increase of 198%
compared to the prior year period, driven by increased activity
under the BARDA contract.
Costs and operating expenses for the third quarter of 2020 were
$15.9 million, an increase of $1.9 million compared to the prior
year period, driven by increased cost of product revenue from
increased sales and offset by lower research and development and
selling, general and administrative expenses.
Net loss for the third quarter of 2020 was $11.3 million or a
loss of $0.08 per share, compared to a net loss of $14.2 million or
a loss of $0.31 per share in the prior year period.
Total cash, cash equivalents, current and long-term marketable
securities, and restricted cash were $61.8 million as of September
30, 2020.
2020 Financial OutlookThe Company has increased
its expectation of full year 2020 total revenue to be between $19.0
million to $20.0 million, including product revenue between $13.0
million to $14.0 million and research and contribution revenue of
approximately $6.0 million. In the U.S., a minimum of 60 T2Dx
Instrument are expected to be sold in the second half of 2020.
Fourth Quarter 2020 Financial OutlookThe
Company expects fourth quarter 2020 total revenue to be between
$8.7 million to $9.7 million, including product revenue between
$7.2 million to $8.2 million and research and contribution revenue
of approximately $1.5 million. In the U.S., a minimum 32 T2Dx
Instruments are expected to be sold in the fourth quarter of
2020.
Webcast and Conference Call InformationT2’s
management team will host a conference call today, November 4,
2020, beginning at 4:30pm ET. Investors interested in listening to
the call may do so by dialing 877-407-9208 for domestic callers or
1-201-493-6784 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 Biosystems T2 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. Furthermore,
statements contained in this document relating to the recent global
outbreak of the novel coronavirus disease (COVID-19), the
impact of which remains inherently uncertain on our financial
results, are forward-looking statements. 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, 2019, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 16, 2020, 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
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share
and per share data) (Unaudited) |
|
|
|
September 30,2020 |
|
|
December 31,2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,059 |
|
|
$ |
11,033 |
|
Marketable securities |
|
|
21,990 |
|
|
|
— |
|
Accounts receivable |
|
|
3,860 |
|
|
|
2,825 |
|
Inventories |
|
|
3,569 |
|
|
|
3,599 |
|
Prepaid expenses and other current assets |
|
|
2,969 |
|
|
|
1,438 |
|
Total current assets |
|
|
51,447 |
|
|
|
18,895 |
|
Property and equipment,
net |
|
|
3,585 |
|
|
|
5,845 |
|
Operating lease right-of-use
assets |
|
|
1,729 |
|
|
|
3,360 |
|
Restricted cash |
|
|
551 |
|
|
|
180 |
|
Marketable securities |
|
|
20,186 |
|
|
|
— |
|
Other assets |
|
|
133 |
|
|
|
206 |
|
Total assets |
|
$ |
77,631 |
|
|
$ |
28,486 |
|
Liabilities and
stockholders’ equity (deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
— |
|
|
$ |
42,902 |
|
Accounts payable |
|
|
2,407 |
|
|
|
3,753 |
|
Accrued expenses and other current liabilities |
|
|
7,654 |
|
|
|
11,207 |
|
Derivative liability |
|
|
— |
|
|
|
2,425 |
|
Deferred revenue |
|
|
290 |
|
|
|
285 |
|
Total current liabilities |
|
|
10,351 |
|
|
|
60,572 |
|
Notes payable, net of current
portion |
|
|
44,612 |
|
|
|
— |
|
Operating lease liabilities,
net of current portion |
|
|
479 |
|
|
|
1,873 |
|
Deferred revenue, net of
current portion |
|
|
300 |
|
|
|
46 |
|
Derivative liability |
|
|
1,235 |
|
|
|
— |
|
Other liabilities |
|
|
3,080 |
|
|
|
— |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no
shares issued and outstanding at September 30, 2020 and
December 31, 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized;
147,954,385 and 50,651,535 shares issued and outstanding at
September 30, 2020 and December 31, 2019,
respectively |
|
|
147 |
|
|
|
51 |
|
Additional paid-in capital |
|
|
430,529 |
|
|
|
342,121 |
|
Accumulated other comprehensive loss |
|
|
(36 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(413,066 |
) |
|
|
(376,177 |
) |
Total stockholders’ equity (deficit) |
|
|
17,574 |
|
|
|
(34,005 |
) |
Total liabilities and
stockholders’ equity (deficit) |
|
$ |
77,631 |
|
|
$ |
28,486 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
3,757 |
|
|
$ |
1,177 |
|
|
$ |
5,843 |
|
|
$ |
3,765 |
|
Research revenue |
|
|
— |
|
|
|
56 |
|
|
|
11 |
|
|
|
269 |
|
Contribution revenue |
|
|
1,488 |
|
|
|
444 |
|
|
|
4,488 |
|
|
|
1,232 |
|
Total
revenue |
|
|
5,245 |
|
|
|
1,677 |
|
|
|
10,342 |
|
|
|
5,266 |
|
Costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
6,833 |
|
|
|
3,944 |
|
|
|
13,804 |
|
|
|
13,153 |
|
Research and development |
|
|
3,965 |
|
|
|
4,098 |
|
|
|
12,883 |
|
|
|
12,047 |
|
Selling, general and administrative |
|
|
5,083 |
|
|
|
5,981 |
|
|
|
16,691 |
|
|
|
19,756 |
|
Total
costs and expenses |
|
|
15,881 |
|
|
|
14,023 |
|
|
|
43,378 |
|
|
|
44,956 |
|
Loss
from operations |
|
|
(10,636 |
) |
|
|
(12,346 |
) |
|
|
(33,036 |
) |
|
|
(39,690 |
) |
Interest
expense, net |
|
|
(646 |
) |
|
|
(1,876 |
) |
|
|
(3,906 |
) |
|
|
(5,658 |
) |
Other
income, net |
|
|
27 |
|
|
|
51 |
|
|
|
53 |
|
|
|
383 |
|
Net
loss |
|
$ |
(11,255 |
) |
|
$ |
(14,171 |
) |
|
$ |
(36,889 |
) |
|
$ |
(44,965 |
) |
Net loss
per share — basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.01 |
) |
Weighted-average number of common shares used in computing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
net loss per share — basic and diluted |
|
|
147,793,891 |
|
|
|
45,413,215 |
|
|
|
112,371,006 |
|
|
|
44,711,463 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(11,255 |
) |
|
$ |
(14,171 |
) |
|
$ |
(36,889 |
) |
|
$ |
(44,965 |
) |
Net
unrealized gain (loss) on marketable securities |
|
|
(36 |
) |
|
|
— |
|
|
|
(36 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(11,291 |
) |
|
$ |
(14,171 |
) |
|
$ |
(36,925 |
) |
|
$ |
(44,965 |
) |
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