Executive Summary

Q4 2024 preliminary product revenue was $2.300M, up 37% year over year, but missed the company’s prior Q4 sepsis product revenue target of $2.5–$3.5M; FY 2024 product revenue was $8.3M, up 23% y/y, below the prior full-year target of $10–$11M .
Commercial execution advanced: 27 T2Dx instruments contracted in 2024 (23 OUS/4 US), exclusive U.S. distribution with Cardinal Health, international distributor adds (Netherlands, Belgium, Qatar, Vietnam, Malaysia, Indonesia), and co-marketing with Prxcision (AI decision support) .
Regulatory pipeline progressed: FDA 510(k) clearance to add Acinetobacter baumannii to T2Bacteria, pediatric claim added for T2Candida; advancing U.S. T2Resistance Panel toward 510(k) submission in Q1 2025 (Breakthrough Device) .
Liquidity remains tight with Q4-end cash of $1.7M; debt load significantly reduced via $30M conversion to equity, cutting quarterly interest by ~80% over the past year .
S&P Global consensus for Q4 2024 revenue/EPS was unavailable at time of access; comparisons vs. Wall Street estimates could not be made. The key stock catalysts remain U.S. distribution ramp (Cardinal), FDA submission/clearances (T2Resistance, Candida auris), and instrument placements .

What Went Well and What Went Wrong

What Went Well

Record product revenue in Q4 ($2.300M), driven by record sepsis test sales; FY 2024 product revenue reached a record $8.3M (+23% y/y) .
Channel leverage established: exclusive U.S. distribution agreement with Cardinal Health and AI co-marketing collaboration with Prxcision to pair direct-from-blood diagnostics with real-time decision support .
Regulatory wins: FDA 510(k) clearances for expanded T2Bacteria (adds A. baumannii) and pediatric indication for T2Candida; T2Resistance U.S. submission targeted for Q1 2025 (Breakthrough Device) .
- CEO quote: “We believe we are well-positioned heading into 2025, and we expect to accelerate our product sales, enhance our operations, and continue to advance our new product pipeline.”

What Went Wrong

Missed company-issued targets: Q4 product revenue ($2.300M) below Q3-issued guidance of $2.5–$3.5M; FY product revenue ($8.3M) below Q2-issued $10–$11M outlook .
Liquidity remains constrained: cash and equivalents fell to $1.7M at 12/31/24, highlighting funding risk despite material debt-for-equity conversion .
Sequential operating loss and margin details for Q4 were not provided in the preliminary update, limiting visibility into product-level profitability improvements that were discussed in Q2/Q3; prior quarters reflected negative gross profit dynamics (e.g., Q3 cost of product revenue $4.101M vs. revenue $1.985M) .

Financial Results

Revenue and EPS vs. Prior Quarters

Metric	Q2 2024	Q3 2024	Q4 2024 (Prelim)
Revenue / Product Revenue ($USD Millions)	$1.952	$1.985	$2.300
Diluted EPS ($)	$(0.66)	$(0.57)	N/A (not disclosed in prelim)

Notes: Q4 figures are preliminary. Management cited 37% y/y growth for Q4 product revenue and 23% y/y for FY product revenue .

Cash and Liquidity

Metric	Q2 2024	Q3 2024	Q4 2024 (Prelim)
Cash & Equivalents ($USD Millions)	$4.2	$2.1	$1.7
Debt Update	Converted $30M term loan to equity (reduces quarterly interest ~80% vs. May 2023) – ongoing	—	$30M conversion reiterated; interest burden reduced ~80% over past year

Operating Expense Reference (for context)

Metric ($USD Millions)	Q2 2024	Q3 2024
Cost of Product Revenue	$2.693	$4.101
R&D	$3.361	$2.667
SG&A	$5.473	$5.378
Net Loss	$(9.243)	$(10.117)
EPS ($)	$(0.66)	$(0.57)

KPIs and Commercial Execution

KPI	Q2 2024	Q3 2024	Q4 2024 / FY 2024
T2Dx Instruments executed (units)	2 (both OUS)	11 (1 US, 10 OUS)	27 in FY 2024 (23 OUS/4 US)
U.S. Distribution	Potential U.S. partner flagged	Exclusive U.S. distribution with Cardinal signed; training/launch underway -	Cardinal training occurring week of Jan 6, 2025
AI Decision Support	—	Co-marketing with Prxcision announced	Confirmed collaboration
Regulatory	T2Candida pediatric 510(k) submitted	T2Candida pediatric 510(k) clearance received	Expanded T2Bacteria (A. baumannii) and T2Candida pediatrics cleared; T2Resistance Q1’25 submission expected

Guidance Changes

Metric	Period	Previous Guidance	Current (Actual/Prelim)	Change
Sepsis product revenue	Q4 2024	$2.5–$3.5M (issued Nov 14, 2024)	$2.300M (prelim)	Lower than guided (miss)
Sepsis product revenue	FY 2024	$10–$11M (reiterated July 29, 2024)	$8.3M (prelim)	Lower than guided (miss)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
U.S. channel expansion	Q2: Exploring U.S. partner ; Q3: Exclusive U.S. distribution signed with Cardinal; access to 90% of U.S. hospitals; training initiated -	Cardinal training scheduled week of Jan 6; expectation it’s a commercial growth driver	Improving
AI / Technology initiatives	Q3: Co-marketing with Prxcision (AI decision support integrated with EHRs)	Collaboration reiterated in prelim results	Stable/Building
Supply chain / Standard of care	Q3: BD BACTEC blood culture shortage underscores need for culture-independent diagnostics; advocacy to change guidelines	Not specifically updated in Q4 prelim	Stable
International expansion	Q2: New distribution in Middle East/Asia ; Q3: 10 OUS instrument contracts	Added distributors (Netherlands, Belgium, Qatar, Vietnam, Malaysia, Indonesia), re-entered Switzerland; sold 4 T2Dx to EU distributor	Improving
Regulatory / R&D	Q2: T2Candida pediatric 510(k) filed; T2Resistance sub pushed to Q4 ; Q3: T2Candida pediatric cleared; T2Resistance sub targeted Q1’25	Expanded T2Bacteria (A. baumannii) cleared; T2Candida pediatric cleared; T2Resistance 510(k) expected Q1’25	Improving
Balance sheet / Capital	Q2: $30M debt converted; ATM usage; focus on cost reductions -	Q3: Cash $2.1M; continued ATM; NASDAQ notice	Q4: Cash $1.7M; interest burden down ~80% from conversion

Management Commentary

“We believe we are well-positioned heading into 2025, and we expect to accelerate our product sales, enhance our operations, and continue to advance our new product pipeline.” — John Sperzel, Chairman & CEO .
On Cardinal Health: “We believe our agreement with Cardinal Health will be transformative… expanding our access to the more than 6,000 U.S. hospitals.” .
On AI collaboration: “By combining our direct-from-blood diagnostics with the AI-driven pRxcision platform, we believe we can empower clinicians… to optimize care and improve outcomes.” .
On regulatory pipeline: Expanded T2Bacteria and pediatric T2Candida clearances; T2Resistance U.S. 510(k) submission planned Q1 2025 (Breakthrough Device) .

Q&A Highlights

Note: No Q4 2024 earnings call transcript was available in our document catalog. Highlights below reflect Q3 2024 Q&A for context.

Cardinal Health ramp: Management expects Cardinal to increase U.S. instrument and consumable sales; initial marketing underway; potential to impact late 2024 but more material in 2025 .
Lyme LDT timing: Targeting a launch in latter half of Q2 2025 to align with seasonality .

Estimates Context

S&P Global consensus for Q4 2024 revenue and EPS was unavailable at the time of access, so we cannot provide an “actual vs. consensus” comparison.
Versus company-issued targets: Q4 product revenue ($2.300M prelim) fell below the $2.5–$3.5M range set on Nov 14, 2024, and FY 2024 product revenue ($8.3M prelim) fell below the $10–$11M range reiterated July 29, 2024 .

Key Takeaways for Investors

Q4 revenue grew 37% y/y to $2.300M but missed the company’s own Q4 target, and FY came in below prior guidance, suggesting a slower-than-expected exit rate into 2025 .
The U.S. distribution agreement with Cardinal Health is the central 2025 growth catalyst, with active training and go-to-market underway; watch for evidence of instrument placements and consumable pull-through in coming quarters - .
Regulatory momentum is positive (expanded T2Bacteria and T2Candida pediatrics cleared; T2Resistance U.S. submission targeted Q1’25), potentially widening the addressable market and enhancing differentiation of direct-from-blood diagnostics .
Liquidity risk persists (Q4 cash $1.7M), albeit with meaningfully reduced interest burden following $30M debt-for-equity conversion; continued access to capital remains critical to fund growth .
International expansion is gaining traction (new distributors and multi-instrument EU sale), diversified away from U.S. timing risk and potentially helping utilization of panels like T2Resistance OUS .
Near-term narrative hinges on execution: proof points should include U.S. deal flow via Cardinal, instrument installs, test utilization growth, and regulatory milestones (T2Resistance 510(k) filing and review) - .
With no available Street consensus, framing will rely on company guidance and sequential KPIs; monitor updated outlook and cash runway disclosures in subsequent filings/communications .

Supporting Documents Cited

Q4/FY 2024 Preliminary Results 8-K and Press Release (Jan 7, 2025):
Q3 2024 Press Release (Nov 14, 2024):
Q3 2024 Earnings Call Transcript (Nov 14, 2024):
Q2 2024 Press Release (Jul 29, 2024):
Other Q4 2024 Press Releases: Dec 18 multi-instrument sale (EU) ; Dec 17 250,000th sepsis test milestone

T2 Biosystems, Inc. (TTOO)·Q4 2024 Earnings Summary