T2 Biosystems Announces Preliminary Q4 Revenue Of $1.7M Vs $2.4M Est.; FY23 Revenue Of $7.2M Vs $7.9M Est.; FY24 Revenue Of $10M-$11M Vs $10.8M Est

Author: Benzinga Newsdesk | February 15, 2024 05:24pm

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

• Achieved full year 2023 total revenue of $7.2 million, including sepsis and related product revenue of $6.8 million and research and contribution revenue of $0.4 million.
• Achieved fourth quarter 2023 total revenue of $1.7 million, comprised entirely of product revenue including record sales of the T2Bacteria Panel in the U.S.
• Executed contracts for 26 T2Dx® Instruments in 2023, including 19 T2Dx Instruments from outside the U.S. and 7 T2Dx Instruments from the U.S.
• Expanded international distribution network to include the Netherlands, Belgium, Vietnam, and the re-entry into Switzerland.
• Eliminated sepsis test backorder as of the end of January 2024.
  
   

Recent Pipeline and Clinical Highlights

• Received FDA 510(k) clearance to add the detection of Acinetobacter baumannii to the FDA-cleared T2Bacteria Panel.
• Submitted a 510(k) premarket notification to the U.S. FDA to expand the use of the T2Candida Panel to include pediatric testing.
• Received Phase 2 award from the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation's LymeX Diagnostics Prize for the T2Lyme Panel.
• Advanced the T2Resistance Panel toward U.S. FDA 510(k) submission, expected to occur during the third quarter of 2024.
• Presented new clinical data at IDWeek 2023 demonstrating speed, accuracy, and clinical benefits of T2Dx Instrument, T2Bacteria Panel, T2Candida Panel, and T2Resistance Panel.
  
   

Financial and Operational Updates

• Presented a detailed plan to Nasdaq Listing Qualifications Hearing Panel on February 15, 2024, to regain compliance with $35 million Market Value of Listed Securities requirement; response expected in the coming weeks.
• Executed agreement with CRG to convert an additional $15 million of the outstanding term loan into shares of common stock and shares of newly designated preferred stock (to the extent CRG's beneficial ownership would be above 49.99% of the Company's outstanding common stock), upon receipt of shareholder approval.
• Amended term loan agreement with CRG, extending the maturity date and interest-only period to December 31, 2025, and reducing the minimum cash covenant from $5.0 million to $500,000.
• Cash and cash equivalents totaled $15.7 million as of December 31, 2023.

"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 pipeline."

2024 Financial Outlook

The Company 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.

Posted In: TTOO