TTOO Shareholder/Stockholder Letter Transcript:
2023
ANNUAL REPORT TO STOCKHOLDERS
TO O U R S TO C K H O L D E R S , E M P LOY E E S A N D F R I E N D S :
The T2 Biosystems team continues to make meaningful progress on our mission by
providing clinicians with the tools to enable faster targeted antimicrobial treatment.
We are focused on driving the adoption of our sepsis products including the T2Dx
Instrument, the T2Bacteria Panel, the T2Candida Panel, and the T2Resistance Panel
to improve patient outcomes, reduce the threat of antimicrobial resistance, drive
long-term sustained growth, and enhance the standard of care for treating patients at
risk of sepsis.
Sepsis is the body s overwhelming and often life-threatening response to infection that
can lead to tissue damage, organ failure, and death. Sepsis is the leading cause of
death in U.S. hospitals, claiming the lives of approximately 350,000 Americans annually.
Sepsis also represents the leading cost of U.S. hospitalization, costing our healthcare
system an estimated $62 billion annually. Lastly, sepsis is the leading cause of 30-day
hospital readmission in the U.S., with 19% of sepsis survivors re-hospitalized within 30
days and 40% within 90 days. These statistics serve as a stark reminder of why T2
Biosystems exists to deliver life-saving innovations to achieve targeted antimicrobial
therapy, faster!
The current standard of care for treating patients at risk of sepsis relies on blood
cultures, which can take 1-5 days, and the administration of antimicrobial therapy
following empiric probability-based protocols, which are only optimal in about onehalf of cases. Our aim is to enhance the current standard of care by enabling faster,
targeted antimicrobial therapy through the deployment of our proprietary technology.
T2 Biosystems has the only U.S. Food and Drug Administration (FDA) cleared products
for detecting sepsis-causing pathogens directly from blood, in only 3-5 hours, without
the need to wait days for a positive culture. In the battle against sepsis, speed is
critical to achieving targeted antimicrobial therapy, as each hour of delayed treatment
increases the risk of death by up to eight percent.
2023 MILESTONES
Our team achieved a number of important milestones during the 2023 calendar year
that we expect to further advance our mission and pave the way for future success:
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.
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.
Submitted three FDA 510(k) premarket noti cations, including 1) the T2Biothreat
Panel to detect high-priority bioterrorism pathogens, 2) the T2Bacteria Panel
expansion to include detection of A. baumannii, and 3) the T2Candida Panel
extension 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 in the fourth quarter of 2024.
Executed an agreement with CRG to convert $10 million of the outstanding term loan
into shares of T2 Biosystems common and preferred stock.
Amended term loan agreement with CRG, extending the maturity date and interestonly period to December 31, 2025, and reducing the minimum cash covenant from
$5.0 million to $500,000.
2024 OUTLOOK
We are focused on three corporate priorities: 1) accelerating our sales, 2) enhancing
our operations, and 3) advancing our pipeline. Commercially, we are focused on
expanding the installed base of T2Dx Instruments and increasing the utilization of
our sepsis test panels. Operationally, we are focused on increasing product gross
margins and continuing to scale our manufacturing processes. Finally, our new product
pipeline is focused on expanding the test menu on our FDA-cleared T2Dx Instrument
including the addition of novel direct from blood tests like the T2Resistance Panel, the
T2Lyme Panel, and the expanded T2Candida Panel to add detection of Candida auris.
In closing, I would like to thank our stockholders, customers, and employees for their
support as we continue to execute our mission to improve the lives of patients around
the world.
John J. Sperzel III
Chairman, President, and Chief Executive Officer
11/20/2024 Letter Continued (Full PDF)