T2 Biosystems (TTOO) Status Update summary

Business developments and partnerships

• Entered a multiyear exclusive U.S. distribution agreement with Cardinal Health for the T2Dx instrument and sepsis test panels, aiming to accelerate revenue growth and expand access to over 6,000 U.S. hospitals.

• Announced a co-marketing collaboration with Precision Inc. to integrate rapid diagnostics with an AI-powered decision support platform for antibiotic stewardship, targeting improved patient outcomes and reduced antimicrobial resistance.

• Maintains a small internal sales team to support existing customers and drive growth alongside Cardinal Health.

Product and regulatory updates

• Received FDA clearance to market the T2Candida Panel for pediatric patients, expanding the addressable market to over 200 U.S. children's hospitals.

• Advanced the T2Resistance Panel toward a planned FDA 510(k) submission in Q4 2024, with the panel already CE-marked and marketed in Europe.

• Plans to launch the T2Lyme Panel as a laboratory-developed test by early 2025, with an in-house laboratory strategy for higher margins and control.

• T2Biothreat Panel, FDA-cleared for six biothreat pathogens, is positioned for government and public health sales, supported by recent legislative and budgetary references.

Financial and operational highlights

• Achieved Q3 2024 total revenue of $2 million, up 35% year-over-year, with sepsis test panel revenue up 42%.

• Executed contracts for 11 T2Dx instruments in Q3, expanded international distribution to Malaysia and Indonesia.

• Projected Q4 2024 sepsis product revenue of $2.5–$3.5 million, representing 49%–109% growth over Q4 2023, and full-year 2024 revenue of $8.5–$9.5 million, up 18%–32%.

• 2024 revenue guidance includes only sepsis products, excluding potential T2Biothreat and T2Lyme sales.