T2 Biosystems Announces Fourth Quarter and Full Year 2022 Financial Results
Recent Commercial and Financial Highlights
- Achieved full year 2022 total revenue of $22.3 million, including product revenue of $11.3 million and research contribution revenue of
$11.0 million . - Achieved record full year 2022 sepsis and related product revenue of
$8.4 million , representing growth of 17% compared to 2021, and record fourth quarter sepsis test revenue in theU.S. - Achieved record full year 2022 sepsis-driven T2Dx® Instrument placements, totaling 51 contracts, consisting of 27 from the U.S. and 24 from outside the U.S.
- Achieved fourth quarter total revenue of
$5.5 million , including product revenue of $2.2 million and research contribution revenue of$3.3 million . - Strengthened the balance sheet in
February 2023 by completing a public offering generating$12.0 million of gross proceeds.
Recent Pipeline and Clinical Highlights
- Advanced
U.S. clinical trial for the T2Resistance® Panel and completed theU.S. clinical trial for the T2Biothreat™ Panel, demonstrating high sensitivity and specificity exceeding target performance requirements. - Initiated studies to expand the T2Bacteria® Panel to include detection of Acinetobacter baumannii, the tenth most common sepsis causing pathogen that has a crude ICU mortality rate of 34.0% to 43.4%.
- Received FDA Breakthrough Device Designation and the LymeX Award for the T2Lyme™ Panel, and announced plans to complete the development of, and commercialize, the
T2Lyme Panel .
“Throughout 2022, the
Fourth Quarter 2022 Financial Results
Total revenue for the fourth quarter of 2022 was
Product costs for the fourth quarter of 2022 were
Net loss for the fourth quarter of 2022 was
Full Year 2022 Financial Results
Total revenue for 2022 was
Operating expenses for 2022 were
Net loss for 2022 was
Cash, equivalents, and restricted cash were
2023 Financial Outlook
The Company expects full year 2023 total sepsis and related product revenue of
Webcast and Conference Call Information
The Company’s management team will host a conference call today,
About
Forward-Looking Statements
This 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
Investor Contact:
ir@T2Biosystems.com
415-937-5406
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,329 | $ | 22,245 | ||||
| Marketable securities | — | 9,996 | ||||||
| Accounts receivable | 2,163 | 5,134 | ||||||
| Inventories | 4,349 | 3,909 | ||||||
| Prepaid expenses and other current assets | 2,582 | 3,110 | ||||||
| Total current assets | 19,423 | 44,394 | ||||||
| Property and equipment, net | 4,533 | 4,675 | ||||||
| Operating lease right-of-use assets | 8,741 | 9,766 | ||||||
| Restricted cash | 1,551 | 1,551 | ||||||
| Other assets | 143 | 153 | ||||||
| Total assets | $ | 34,391 | $ | 60,539 | ||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,296 | $ | 2,832 | ||||
| Accrued expenses and other current liabilities | 7,647 | 8,338 | ||||||
| Operating Lease Liability | 1,352 | — | ||||||
| Warrant Liability | 39 | — | ||||||
| Deferred revenue | 172 | 518 | ||||||
| Total current liabilities | 10,506 | 11,688 | ||||||
| Notes payable | 49,651 | 47,790 | ||||||
| Operating lease liabilities, net of current portion | 8,214 | 9,359 | ||||||
| Deferred revenue, net of current portion | 52 | 28 | ||||||
| Derivative liability | 1,088 | — | ||||||
| Other liabilities | 4,849 | 4,577 | ||||||
| Total liabilities | 74,360 | 73,442 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ deficit: | ||||||||
| Preferred stock, issued and outstanding |
— | — | ||||||
| Common stock, and 3,328,017 shares issued and outstanding at |
8 | 166 | ||||||
| Additional paid-in capital | 494,556 | 459,151 | ||||||
| Accumulated other comprehensive (loss) income | — | (4 | ) | |||||
| Accumulated deficit | (534,533 | ) | (472,216 | ) | ||||
| Total stockholders’ deficit | (39,969 | ) | (12,903 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 34,391 | $ | 60,539 | ||||
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
| Year ended | ||||||||
| 2022 | 2021 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 11,259 | $ | 16,646 | ||||
| Contribution revenue | 11,046 | 11,412 | ||||||
| Total revenue | 22,305 | 28,058 | ||||||
| Costs and expenses: | ||||||||
| Cost of product revenue | 21,139 | 20,703 | ||||||
| Research and development | 25,932 | 21,801 | ||||||
| Selling, general and administrative | 30,744 | 28,527 | ||||||
| Total costs and expenses | 77,815 | 71,031 | ||||||
| Loss from operations | (55,510 | ) | (42,973 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 8 | 112 | ||||||
| Interest expense | (6,084 | ) | (7,596 | ) | ||||
| Change in fair value of derivative instrument | (1,088 | ) | 1,010 | |||||
| Change in fair value of warrant liability | 326 | — | ||||||
| Other income | 125 | 218 | ||||||
| Other expense | (15 | ) | — | |||||
| Other gains/losses | (79 | ) | (12 | ) | ||||
| Total other expense | (6,807 | ) | (6,268 | ) | ||||
| Net loss | $ | (62,317 | ) | $ | (49,241 | ) | ||
| Deemed dividend on Series A redeemable convertible preferred stock | $ | (330 | ) | $ | - | |||
| Net loss attributable to common stockholders | $ | (62,647 | ) | $ | (49,241 | ) | ||
| Net loss per share — basic and diluted | $ | (12.28 | ) | $ | (15.50 | ) | ||
| Weighted-average number of common shares used in computing net loss per share — basic and diluted |
5,100,395 | 3,177,228 | ||||||
| Other comprehensive loss: | ||||||||
| Net loss | $ | (62,317 | ) | $ | (49,241 | ) | ||
| Net unrealized (loss) gain on marketable securities arising during the period | 2 | (4 | ) | |||||
| Less: net realized (gain) loss on marketable securities included in net loss | 2 | (9 | ) | |||||
| Total other comprehensive (loss) gain, net of taxes | 4 | (13 | ) | |||||
| Comprehensive loss | $ | (62,313 | ) | $ | (49,254 | ) | ||
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
| Three Months ended | ||||||||
| 2022 | 2021 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 2,215 | $ | 4,012 | ||||
| Contribution revenue | 3,268 | 2,968 | ||||||
| Total revenue | 5,483 | 6,980 | ||||||
| Costs and expenses: | ||||||||
| Cost of product revenue | 3,768 | 5,362 | ||||||
| Research and development | 4,876 | 5,353 | ||||||
| Selling, general and administrative | 6,673 | 6,544 | ||||||
| Total costs and expenses | 15,317 | 17,259 | ||||||
| Loss from operations | (9,834 | ) | (10,279 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 2 | 94 | ||||||
| Interest expense | (1,528 | ) | (944 | ) | ||||
| Change in fair value of derivative instrument | 704 | (1,010 | ) | |||||
| Change in fair value of warrant liability | 147 | — | ||||||
| Other income | 100 | (5 | ) | |||||
| Other gains/losses | (4 | ) | — | |||||
| Total other expense | (579 | ) | (1,865 | ) | ||||
| Net loss | $ | (10,413 | ) | $ | (12,144 | ) | ||
| Deemed dividend on Series A redeemable convertible preferred stock | — | — | ||||||
| Net loss attributable to common stockholders | $ | (10,413 | ) | $ | (12,144 | ) | ||
| Net loss per share — basic and diluted | $ | (1.41 | ) | $ | (3.65 | ) | ||
| Weighted-average number of common shares used in computing net loss per share — basic and diluted |
7,405,889 | 3,323,451 | ||||||
| Other comprehensive loss: | ||||||||
| Net loss | $ | (10,413 | ) | $ | (12,144 | ) | ||
| Net unrealized (loss) gain on marketable securities arising during the period | — | (13 | ) | |||||
| Less: net realized (gain) loss on marketable securities included in net loss | — | 5 | ||||||
| Total other comprehensive (loss) gain, net of taxes | — | (8 | ) | |||||
| Comprehensive loss | $ | (10,413 | ) | $ | (12,152 | ) | ||
Source: T2 Biosystems, Inc.