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T2 Biosystems, Inc. (TTOO)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 revenue was $2.0M (all sepsis products), flat year over year as 27% growth in sepsis test panels was offset by lower international instrument sales; operating loss improved 27% y/y to $(9.6)M on lower COGS and opex .
  • Management reiterated FY24 sepsis product revenue guidance of $10–$11M (+49% to +64% y/y) and highlighted 2H weighting (60% of FY) with 6 instruments already contracted in July ($0.4M Q3 revenue contribution) .
  • Strategic catalysts: (1) BD blood culture media shortage through Q4’24 could accelerate adoption of T2’s direct-from-blood tests; (2) potential U.S. distribution partnership with a multibillion-dollar healthcare company; (3) T2Lyme LDT launch planned Q3’24; (4) T2Resistance U.S. 510(k) submission targeted for Q4’24 .
  • Balance sheet/ops: $30M CRG debt converted over the last year (≈80% reduction), $8.0M gross capital raised in Q2, facility consolidation ($1M annual savings) and PEO adoption (~$0.4M annual savings) support cash burn improvements, though quarter-end cash was $4.2M .

What Went Well and What Went Wrong

  • What Went Well
    • Record Q2 and 1H sepsis test revenue; T2Bacteria and T2Resistance drove 27% y/y test-panel growth; cost of product revenue fell 45% y/y, and operating loss improved 27% y/y .
    • Commercial momentum: new distribution agreements in Qatar, Hong Kong, Macau, Malaysia, Indonesia; 2 T2Dx instrument contracts in Q2 and 6 more in July (international) with ~$400K expected in Q3 revenue .
    • CEO tone on catalysts: “We are highly encouraged by the record second quarter… Moving forward, we expect incremental sepsis revenue growth as a result of the recently FDA-cleared expanded T2Bacteria Panel… potential U.S. distribution partnership… and recently signed international distribution agreements” .
  • What Went Wrong
    • Total revenue flat y/y at $2.0M as lower international instrument sales offset strong test growth; net loss was $(9.2)M and cash declined q/q to $4.2M despite capital raise .
    • Instrument sales lighter than expected in Q2; several deals slipped into July (management indicated the rollover and Q3 capture) .
    • T2Resistance internal V&V studies were delayed (manufacturing issues in 2H’23 prioritized supply to customers); U.S. 510(k) submission shifted from Q3 to Q4’24 .

Financial Results

YoY comparison – Q2 2023 vs Q2 2024

Metric (USD, unless noted)Q2 2023Q2 2024
Total Revenue ($000)$1,964 $1,952
Cost of Product Revenue ($000)$4,869 $2,693
Research & Development ($000)$3,850 $3,361
Selling, General & Administrative ($000)$6,296 $5,473
Loss from Operations ($000)$(13,051) $(9,575)
Net Loss ($000)$(6,347) $(9,243)
Diluted EPS$(7.84) $(0.66)
CommentaryTest revenue +27% y/y; total revenue flat due to lower international instruments Material COGS and opex reductions improved operating loss

Sequential comparison – Q1 2024 vs Q2 2024

Metric (USD, unless noted)Q1 2024Q2 2024
Total/Product Revenue ($000)$2,061 $1,952
Cost of Product Revenue ($000)$4,202 $2,693
Research & Development ($000)$3,721 $3,361
Selling, General & Administrative ($000)$6,738 $5,473
Net Loss ($000)$(13,534) $(9,243)
Diluted EPS$(2.66) $(0.66)
Cash & Cash Equivalents (end of period, $000)$6,208 $4,246
CommentarySepsis test panels grew +23% vs Q4’23; $2.2M ATM proceeds; debt reduced ~80% y/y by May 6 Panel sales +12% seq. but lower instruments; operating metrics improved; $8.0M gross raise in Q2

KPIs and operational items

KPIQ1 2024Q2 2024
Sepsis test revenue growth (y/y)+25% (led by T2Candida and strong T2Resistance internationally) +27% (led by T2Bacteria and T2Resistance)
T2Dx Instruments – contracts8 total (5 OUS, 3 U.S.) 2 OUS; +6 OUS in July (Q3 rev ≈ $0.4M)
Distribution agreementsQatar added Qatar, Hong Kong, Macau; Malaysia, Indonesia (announced)
Guidance$10–$11M sepsis revenue (FY24) Reiterated $10–$11M (FY24)

Estimates vs actuals: Wall Street consensus (S&P Global) was unavailable at the time of analysis; we attempted retrieval but did not receive data. As a result, beats/misses vs consensus could not be determined.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Sepsis Product RevenueFY 2024$10.0M–$11.0M (49%–64% y/y) $10.0M–$11.0M (49%–64% y/y) Maintained
NotesGuidance excludes potential T2Biothreat and T2Lyme sales Still excludes T2Biothreat/T2Lyme; 2H weighted

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
Supply chain / market conditionsNo BD shortage; focus on eliminating backorders and improving manufacturing FDA/CDC alerts on critical BD blood culture media shortage through Q4’24; T2’s direct-from-blood tests positioned as alternative Positive adoption tailwind emerging
U.S. commercial strategy / partnershipsExploring partnerships; expanding Vizient agreement (Q1) In negotiations with a multibillion-$ U.S. healthcare company for distribution Potential scale-up catalyst
Product performanceRecord U.S. T2Bacteria in Q4; Q1 test growth +25% y/y Record Q2 and 1H test revenue; +27% y/y test growth; +12% seq. panels Strengthening
International expansionNew distributors: Netherlands, Belgium, Vietnam, Switzerland (Q4); Qatar (Q1) Added Qatar, Hong Kong, Macau; Malaysia, Indonesia; 2 instruments Q2 and 6 in July Broadening footprint
Regulatory / pipelineFDA clearance: expanded T2Bacteria; T2Candida pediatric 510(k) filed (Q4–Q1) T2Resistance U.S. 510(k) shifted to Q4’24; T2Lyme LDT launch planned Q3’24 Near-term catalysts, minor delay
Operations / costsBackorders cleared; ERP cutover planned; debt reduction & covenant relief (Q4) Facility consolidation ($1M/yr), PEO adoption ($0.4M/yr); debt down ~80% y/y Cost structure improving

Management Commentary

  • “We are highly encouraged by the record second quarter and record first half of 2024 sepsis test revenue… we expect incremental sepsis revenue growth as a result of the recently FDA-cleared expanded T2Bacteria Panel… potential U.S. distribution partnership… and recently signed international distribution agreements” – John Sperzel, CEO .
  • “Second quarter 2024 revenues were $2 million, all from sepsis product sales… cost of product revenues were $2.7 million, a 45% decrease… SG&A down 13%… net loss was $9.2 million, $0.66 per share” – John Sprague, CFO .
  • “We believe the BD blood culture media bottle shortage represents an opportunity for T2 Biosystems to increase adoption of our direct-from-blood diagnostics” – CEO .
  • “We plan to submit [T2Resistance] 510(k) during the fourth quarter of 2024” – CEO .
  • “We plan to launch the T2Lyme Panel as a Laboratory Developed Test (LDT) in the third quarter of 2024” – CEO .

Q&A Highlights

  • 2H revenue weighting and visibility: FY guide maintained; mix ~40% 1H / 60% 2H; 6 instruments already contracted in July to contribute ~$400K in Q3 .
  • U.S. distribution partner: Negotiations with a multibillion-$ healthcare company; expected to materially improve commercial scale; details pending .
  • Pipeline timelines: T2Resistance U.S. 510(k) moved to Q4’24 due to prior manufacturing constraints; T2Lyme LDT on track Q3’24 .
  • Commercial organization: U.S. sales force reduced in anticipation of partner; team structured to work with partner .
  • Balance sheet: S-3/ATM in place; management aims to be “smart” about timing capital raises around catalysts .

Estimates Context

  • S&P Global consensus estimates for Q2’24 revenue/EPS and forward periods were unavailable at the time of analysis despite attempted retrieval; as a result, we cannot quantify beats/misses vs consensus. We will update when S&P Global data becomes available.

Key Takeaways for Investors

  • Test-panel momentum is intact with record Q2/1H test revenue and significant y/y COGS/opex reductions driving improved operating loss; the growth algorithm increasingly hinges on test utilization rather than instruments alone .
  • The BD blood culture media shortage through Q4’24 is a unique, time-bound catalyst that directly benefits T2’s culture-independent positioning; proactive outreach is underway .
  • Near-term catalysts (Q3 T2Lyme LDT, potential U.S. distribution partnership, Q4 T2Resistance 510(k) submission) could re-rate adoption expectations and distribution reach .
  • International expansion is accelerating with multiple new distribution agreements and tangible instrument orders rolling from Q2 into Q3; this supports 2H guide weighting .
  • Balance sheet actions (debt-to-equity exchanges, equity capital, facility/PEO savings) reduce cash burn and interest burden; however, liquidity remains a monitoring point with $4.2M cash at Q2-end .
  • Watch the cadence of U.S. partner announcement/launch, Q3 instrument revenue capture (~$0.4M), and regulatory milestones as key stock reaction catalysts in 2H’24 .
  • Risk checks: instrument sales lumpiness; potential pipeline/regulatory slippage; need for timely capital infusions versus catalyst timing .

Additional Relevant Press Releases (context)

  • Earnings press release (July 29, 2024) with full financials and reiterated outlook .
  • 8-K furnishing the press release and call transcript (July 29, 2024) .
  • Q1 2024 8-K and press release for prior-quarter trend analysis (May 6, 2024) .