UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition |
On July 29, 2024, the Company issued a press release announcing its financial results for its fiscal quarter ended June 30, 2024, and held a conference call to discuss those results. A copy of the Company’s press release and a copy of the transcript of the conference call are furnished with this report as Exhibits 99.1 and 99.2, respectively.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. Furthermore, such information, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly stated by specific reference in such a filing.
| Item 8.01 | Other Events |
On July 29, 2024, the Company reported the following financial, operational and clinical updates for the quarter ended June 30, 2024:
| • | Achieved second quarter 2024 total revenue of $2.0 million, flat compared to the prior year period. |
| • | Achieved record quarterly and first half sepsis test revenue, representing growth of 27% and 25% respectively compared to the prior year periods, led by T2Bacteria® and T2Resistance® panel sales. |
| • | Loss from operations was $9.6 million in the second quarter of 2024, a 27% improvement compared to $13.1 million in the second quarter of 2023. |
| • | Net loss for the second quarter of 2024 was $9.2 million, $0.66 per share, compared to a net loss of $6.3 million, or $7.84 per share, in the prior year period |
| • | Cash and cash equivalents totaled $4.2 million as of June 30, 2024, compared to $6.2 million as of March 31, 2024. |
| • | Executed contracts for 2 T2Dx® Instruments during the second quarter, both from outside the U.S. and have executed contracts for 6 additional instruments in July 2024. |
| • | Signed multiple international distribution agreements in the Middle East and Asia, including Qatar, Hong Kong, Malaysia, Indonesia, and Macau. |
| • | Converted $30.0 million of term loan debt with CRG Servicing LLC (“CRG”) in exchange for T2 Biosystems equity, reducing both total debt and quarterly interest payments to CRG by approximately 80% percent from May 2023 amounts. |
| • | Completed clinical studies required to launch the T2Lyme Panel as a laboratory developed test (LDT) in the third quarter of 2024. |
| • | 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, now expected to occur during the fourth quarter of 2024. |
| • | Presented new data at the American Society for Microbiology (ASM) Microbe 2024 conference demonstrates the clinical benefits of the culture-independent T2Candida Panel. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our growth opportunities as a result of the receipt of FDA 510(k) clearance for the T2Candida® Panel to include pediatric testing and development for the T2Resistance Panel, financial results and cash balance, financial outlook, instrument contracts, timing of completing clinical trials and filing of an FDA submission, 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. The [preliminary], estimated financial results contained in this current report on Form 8-K have not been compiled or examined by our independent auditors and they are subject to revision as we prepare our financial statements as of and for the quarter ended June 30, 2024, including all disclosures required by U.S. generally accepted accounting principles. While we believe that such information and estimates are based on reasonable assumptions, actual results may vary, and such variations may be material. You should not place undue reliance on such preliminary information and estimates because they may prove to be materially inaccurate. 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, 2023, 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 Current Report on Form 8-K. Any such forward-looking statements represent management’s estimates as of the date of this Current Report on Form 8-K. 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 Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release issued July 29, 2024 | |
| 99.2 | Transcript of conference call held on July 29, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| T2 BIOSYSTEMS, INC. | ||||||
| Date: July 29, 2024 | By: | /s/ John Sprague | ||||
| John Sprague | ||||||
| Chief Financial Officer | ||||||