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Tivic Health Systems, Inc. (TIVC)·Q3 2025 Earnings Summary

Executive Summary

  • Tivic reported Q3 2025 revenue of $0.146M, a sequential increase vs Q2 ($0.086M) and up 15.9% year over year; EPS improved to $(1.97) from $(3.93) in Q3 2024 as the company executed the wind-down of its consumer business and advanced its biologics pipeline .
  • Reported gross profit was $(0.145)M due to a $0.230M inventory reserve tied to the consumer exit; on an adjusted basis, gross margin was 42% vs 35% a year ago, indicating underlying product margin improvement despite restructuring charges .
  • Management confirmed completion of Entolimod cell line verification (a key cGMP milestone) and transfer of two INDs, while noting delays at a contract manufacturer; BARDA engagement is advancing via a requested TechWatch meeting—key near-term catalysts for stockpile/commercial readiness .
  • Guidance: board-approved wind-down of ClearUP with advertising discontinued Oct 1; company expects minimal to no revenue until regulatory approvals are obtained; incremental exit costs of $20–$50k anticipated by year-end .
  • Liquidity strengthened: cash rose to $3.45M at quarter-end with $3.8M net proceeds from financing tranches and ~$3.5M committed remaining under a preferred equity agreement; zero debt maintained .

What Went Well and What Went Wrong

What Went Well

  • Completed Entolimod cell line verification—“a critical first step to establishing reproducibility and scalability in our drug manufacturing,” advancing cGMP readiness for the future BLA .
  • Strategic pipeline expanded: two INDs transferred from Statera to Tivic, enabling clinical trials in neutropenia and cancer-related conditions; management expects ability to move directly into Phase 2 in certain indications based on existing safety data .
  • Positive VNS Optimization findings uncovered parameters affecting autonomic activity, informing personalization and new IP, potentially enabling clinical outcomes comparable or better than implanted devices .

What Went Wrong

  • Contract manufacturing partner experienced financial stress, causing schedule delays; Tivic is working with the team and alternative partners to stabilize timelines .
  • Gross loss driven by $0.230M inventory reserve tied to ClearUP exit; net loss widened to $(2.596)M vs $(1.431)M YoY as OpEx increased with biopharma build-out and consumer wind-down actions .
  • Near-term revenue headwind: company expects minimal to no revenue post consumer exit until other product candidates receive approvals and are commercialized .

Financial Results

Income Statement and EPS Trend

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD)$126,000 $70,000 $86,000 $146,000
Gross Profit ($USD)$44,000 $50,000 $54,000 $(145,000)
Gross Margin % (ex inventory reserve)35% 72% 63% 42%
Operating Expenses ($USD)$1,475,000 $1,556,000 $1,988,000 $2,338,000
Net Loss ($USD)$(1,431,000) $(1,502,000) $(1,931,000) $(2,596,000)
Diluted EPS ($USD)$(3.93) $(2.52) $(2.19) $(1.97)

Notes:

  • Q3 2025 gross loss reflects $230,000 inventory reserve related to consumer exit; underlying gross margin improved to 42% YoY vs 35% .

Balance Sheet and Liquidity

MetricDec 31, 2024Jun 30, 2025Sep 30, 2025
Cash And Equivalents ($USD)$2,002,000 $1,184,000 $3,450,000
Total Assets ($USD)$2,807,000 $4,508,000 $6,229,000
Total Stockholders’ Equity ($USD)$2,535,000 $3,687,000 $5,591,000
Total Current Liabilities ($USD)$272,000 $821,000 $638,000
Total Debt ($USD)$0 $0 $0

Operational and Financing KPIs

KPIQ3 2025Q2 2025Q1 2025
Inventory Reserve (Exit) ($USD)$230,000 ——
Other Exit Write-offs ($USD)$117,000 ——
Financing Proceeds ($USD)$3,800,000 net tranches closed $1,400,000 preferred tranches; $547,000 ELOC net $1,700,000 ATM net post-quarter
Preferred Equity Remaining Commitment ($USD)~$3,500,000 at 9/30 ~$7,000,000 remaining Up to $8,400,000 capacity

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue trajectoryQ4 2025 onwardNone explicit“Minimal to no revenue until regulatory approval and commercialization of other product candidates” Lowered
Consumer business wind-downBy year-end 2025Plan to exit by end-of-year Board-determined wind-down and exit substantially complete by year-end Maintained/confirmed
Advertising for ClearUPEffective Oct 1, 2025Ongoing marketingDiscontinued all advertising and marketing initiatives Lowered
Exit-related expendituresQ4 2025Not previously quantifiedAdditional $20,000–$50,000 expected by year-end New
Exit-related charges recognizedQ3 2025N/A$230,000 inventory reserve (COGS) and $117,000 other expense New commentary
Liquidity outlookNear term~$7.0M remaining committed (Q2) ~$3.5M committed remaining at 9/30; cash $3.45M; no debt Updated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Biologics manufacturing readinessEntered GMP validation agreement post Q1; planning Type B FDA meeting (Q2) Completed Entolimod cell line verification; CM partner stress causing delays; engaging alternates Progressing with mitigation
Government/BARDA engagementWhite House and FDA briefings; MHSRS interest (Q2) Requested BARDA TechWatch meeting to discuss stockpiling Deepening engagement
Clinical pipeline (INDs, indications)Option exercised to license neutropenia; planning IND transfer (Q1/Q2) Two INDs transferred to Tivic; potential to move directly to Phase 2 in neutropenia/lymphocyte exhaustion Expanding programs
VNS programCompleted study visits; results later this year (Q2) Optimization trial findings: sympathetic and parasympathetic parameters; additional IP filed Advancing insights
Consumer businessShift away; plan to exit by year-end (Q2) Board-approved wind-down; advertising stopped; inventory/write-offs recorded Accelerated exit
Financing/capital$25M ELOC; up to $8.4M purchase agreement (Q1); tranches raised in Q2 $3.8M net proceeds in Q3; ~$3.5M committed remaining; cash improved to $3.45M; no debt Strengthened liquidity

Management Commentary

  • “Following our discussions at the Military Health System Research Symposium and continued engagement with key government agencies, we are encouraged by the interest in our lead product candidate, Entolimod for acute radiation syndrome (ARS), as a military medical countermeasure and stockpile drug.” — Jennifer Ernst, CEO .
  • “Starting the cGMP manufacturing process with successful cell line verification was a critical first step to establishing reproducibility and scalability in our drug manufacturing.” — Jennifer Ernst, CEO .
  • “Subsequent to the quarter’s end, we also reported the compelling findings from Tivic’s VNS Optimization Trial… intended to protect Tivic’s prescription device development for commercialization and licensing.” — Jennifer Ernst, CEO .
  • “During the third quarter, we recorded reserves for excess and obsolete inventory of $230,000… We also wrote off certain assets related to ClearUP with a net book value of $117,000.” — Lisa Wolf, CFO .
  • “We do not expect to incur additional significant costs associated with our exit from the consumer device business.” — Lisa Wolf, CFO .

Q&A Highlights

  • The call was pre-recorded; no live Q&A session was conducted .
  • Management clarified exit accounting (inventory reserves and write-offs) and indicated no further significant exit costs expected, while reiterating that funding plus remaining commitments should support progress to CGMP validation for Entolimod .
  • CEO addressed manufacturing delays at the CM partner and contingency plans with other manufacturers to maintain timelines .

Estimates Context

  • Wall Street consensus estimates from S&P Global were unavailable for EPS and revenue for Q3 2025; therefore, no beat/miss versus consensus can be determined at this time. Values retrieved from S&P Global.*
  • Actuals for Q3 2025 (from company filings): Revenue $0.146M, EPS $(1.97) .

Key Takeaways for Investors

  • Near-term revenue will likely trough to minimal levels as Tivic exits consumer sales and pivots fully to prescription therapeutics; watch for BARDA TechWatch and stockpile developments as the primary commercial catalyst path .
  • Manufacturing progress is tangible (cell line verified) but timelines carry execution risk due to CM financial stress; management is pursuing parallel partners to de-risk the path to CGMP and BLA readiness .
  • Underlying product margin quality remains constructive (42% adjusted GM vs 35% YoY) even as restructuring charges depress reported gross profit; operating expense growth reflects biopharma build-out .
  • Liquidity improved (cash $3.45M; $3.8M raised; ~$3.5M committed remaining; no debt), supporting manufacturing validation milestones—monitor further tranche closings and potential non-dilutive funding tied to government programs .
  • Clinical optionality is expanding (IND transfers enabling Phase 2 in neutropenia/lymphocyte exhaustion; oncology adjunctive potential), providing multiple shots on goal alongside ARS stockpile opportunity .
  • VNS platform advances and newly filed IP may open alternative commercial opportunities; however, management is prioritizing biologics resource allocation near term .
  • With no consensus coverage, trading may be catalyst-driven; upcoming regulatory/manufacturing milestones and government engagement updates are likely to dominate narrative and price action .

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