Full Press Release Details
T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2023 Financial Results
Advanced multiple new products and achieved record fourth quarter U.S. T2Bacteria Panel sales
LEXINGTON, Mass., February 15, 2024 (GLOBE NEWSWIRE) T2 Biosystems, Inc. (NASDAQ:TTOO) (the Company ), a leader in the
rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the fourth quarter and full year ended December 31, 2023.
Full Year 2023 and Recent Commercial Highlights
Recent Pipeline and Clinical Highlights
Financial and Operational Updates
We made considerable progress across the business during 2023, increasing our global installed base of
T2Dx Instruments, generating record U.S. sales of our T2Bacteria Panel, strengthening our supply chain and manufacturing operations, advancing multiple new product development initiatives, and strengthening our balance sheet, stated John
Sperzel, Chairman and CEO of T2 Biosystems. We are very excited by the progress on our new product pipeline, which includes the recent FDA clearances for the T2Biothreat Panel and the expanded T2Bacteria Panel to include the detection of
Acinetobacter baumannii, as well as the pending FDA clearance to expand the T2Candida Panel to include pediatric testing. Additionally, we have three pipeline products that have received FDA Breakthrough Device designation, including the
T2Resistance Panel, the T2Lyme Panel, and the Candida auris test. We believe we are well-positioned heading into 2024, and we expect to accelerate our product sales, enhance our operations, and continue to advance out new product
2024 Financial Outlook
expects full year 2024 total sepsis and related product revenue of $10.0 million to $11.0 million, representing growth of 49% to 64%, compared to $6.7 million in 2023. The Company s 2024 revenue guidance consists entirely of
sepsis and related product revenue and does not include potential sales of the T2Biothreat Panel or the T2Lyme Panel.
Webcast and Conference Call
The Company s management team will host a conference call today, February 15, 2024, beginning at 4:30 pm ET. Investors
interested in listening to the call may do so by dialing 888-506-0062 for domestic callers or
973-528-0011 for International callers and using conference ID 106354 approximately five minutes prior to the start time. A live and recorded webcast of the call will be
available on the Investors section of the Company s website at www.t2biosystems.com.
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, 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, the T2Bacteria Panel, the T2Candida Panel, the T2Resistance Panel, and the T2Biothreat Panel, and are powered by the proprietary T2 Magnetic Resonance (T2MR ) technology. T2 Biosystems has an active pipeline of future
products, including the U.S. T2Resistance Panel, the Candida auris test, and the T2Lyme Panel. For more information, please visit www.t2biosystems.com.
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 growth opportunities as a result of the receipt of FDA 510(k) clearance for the T2Biothreat Panel and 510(k) clearance to add Acinetobacter baumannii detection to the FDA-cleared T2Bacteria Panel, maintenance of our Nasdaq listing, our market opportunity, financial results, 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 for the fourth quarter and fiscal year ended 2023 contained in this press release contain forward-looking statements and are subject to the completion of
management s and the audit committee s final reviews and our other financial closing procedures and are therefore subject to change. You should not place undue reliance on such preliminary information and estimates because they may prove
to be materially inaccurate. The preliminary information and estimates 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 December 31, 2023, including all disclosures required by U.S. generally accepted accounting
principles. While we believe that such preliminary information and estimates are based on reasonable assumptions, actual results may vary, and such variations may be material. 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, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 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 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.
Philip Trip Taylor, Gilmartin Group