T2 Biosystems Announces First Quarter 2023 Financial Results
Recent Financial and Operational Highlights
- Achieved first quarter total revenue of
$2.1 million , including sepsis and related product revenue of$1.7 million and research contribution revenue of$0.4 million . - Increased sepsis panel revenue by 11% year over year, driven by increased T2Bacteria® Panel sales of 109% in the
U.S. and 55% globally. - Executed contracts for 5 T2Dx® Instruments during the first quarter.
- Secured multi-year pricing agreements with two large
U.S. health systems, representing a total of 69 Hospitals, for T2Dx Instruments, T2Bacteria Panels and T2Candida® Panels. - Announced exploration of strategic alternatives and implemented a restructuring program completed this past week including an incremental workforce reduction of nearly 30%.
Recent Pipeline and Clinical Highlights
- Filed FDA submission for T2Biothreat™ Panel, a direct-from-blood test that runs on the FDA-cleared T2Dx Instrument and detects six biothreat pathogens identified as threats by the
CDC . - Applied for FDA Breakthrough Device Designation for Candida auris, a multidrug-resistant fungal pathogen that has been labeled as a serious global health threat with mortality rate up to 60%.
- Completed assay development for T2Lyme™ Panel and established preliminary level of detection (LOD) of 2 CFU/mL.
- Advanced
U.S. clinical trial for T2Resistance® Panel, completing nearly 90% of patient enrollment.
“In an effort to maximize value, we have engaged an advisory firm to explore all potential strategic alternatives. In addition, to preserve capital, decrease quarterly cash usage and position the Company to explore strategic alternatives, we have simultaneously implemented a restructuring program,” stated
First Quarter 2023 Financial Results
Total revenue for the first quarter of 2023 was
Cost of product revenue for the first quarter of 2023 was
Net loss for the first quarter of 2023 was
Cash and cash equivalents totaled
2023 Financial Outlook
The Company reiterates its full year 2023 financial outlook and continues to expect 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
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
2023 |
2022 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,117 | $ | 10,329 | ||||
| Accounts receivable | 1,323 | 2,163 | ||||||
| Inventories | 4,936 | 4,285 | ||||||
| Prepaid expenses and other current assets | 2,549 | 2,582 | ||||||
| Total current assets | 18,925 | 19,359 | ||||||
| Property and equipment, net | 4,801 | 4,533 | ||||||
| Operating lease right-of-use assets | 8,420 | 8,741 | ||||||
| Restricted cash | 551 | 1,551 | ||||||
| Other assets | 35 | 143 | ||||||
| Total assets | $ | 32,732 | $ | 34,327 | ||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,131 | $ | 1,296 | ||||
| Accrued expenses and other current liabilities | 5,162 | 7,269 | ||||||
| Operating lease liability | 1,415 | 1,352 | ||||||
| Warrant liabilities | 7,972 | 39 | ||||||
| Deferred revenue | 149 | 172 | ||||||
| Total current liabilities | 17,829 | 10,128 | ||||||
| Notes payable | 50,108 | 49,651 | ||||||
| Operating lease liabilities, net of current portion | 7,832 | 8,214 | ||||||
| Deferred revenue, net of current portion | 74 | 52 | ||||||
| Derivative liability related to Term Loan | 1,858 | 1,088 | ||||||
| Accrued interest on term loan | 4,917 | 4,849 | ||||||
| Total liabilities | 82,618 | 73,982 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ deficit | ||||||||
| Preferred stock, |
— | — | ||||||
| Common stock, 7,716,519 shares issued and outstanding at |
21 | 8 | ||||||
| Additional paid-in capital | 502,277 | 494,556 | ||||||
| Accumulated deficit | (552,184 | ) | (534,219 | ) | ||||
| Total stockholders’ deficit | (49,886 | ) | (39,655 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 32,732 | $ | 34,327 | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended |
||||||||
| 2023 | 2022 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 1,655 | $ | 3,844 | ||||
| Contribution revenue | 423 | 3,390 | ||||||
| Total revenue | 2,078 | 7,234 | ||||||
| Costs and expenses: | ||||||||
| Cost of product revenue | 3,995 | 6,205 | ||||||
| Research and development | 4,471 | 6,656 | ||||||
| Selling, general and administrative | 7,299 | 9,230 | ||||||
| Total costs and expenses | 15,765 | 22,091 | ||||||
| Loss from operations | (13,687 | ) | (14,857 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 2 | 3 | ||||||
| Interest expense | (1,522 | ) | (1,650 | ) | ||||
| Change in fair value of derivative related to Term Loan | (770 | ) | — | |||||
| Change in fair value of warrant liabilities | (1,304 | ) | — | |||||
| Other income | — | 11 | ||||||
| Other expense | (682 | ) | — | |||||
| Other losses | (2 | ) | (2 | ) | ||||
| Total other expense | (4,278 | ) | (1,638 | ) | ||||
| Net loss and comprehensive loss | $ | (17,965 | ) | $ | (16,495 | ) | ||
| Net loss per share — basic and diluted | $ | (1.32 | ) | $ | (4.86 | ) | ||
| Weighted-average number of common shares used in computing net loss per share — basic and diluted |
13,633,352 | 3,397,103 | ||||||
Source: T2 Biosystems, Inc.