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Tivic Health Systems, Inc. (TIVC)·Q1 2025 Earnings Summary

Executive Summary

  • Tivic’s Q1 2025 was an execution-heavy transition quarter: revenue fell to $0.07M as advertising for ClearUP was intentionally reduced 92%, while gross margin improved to 72% and net loss remained flat at $(1.5)M year over year . The quarter focused on advancing the new biopharma program (Entolimod/Entolasta) and the ncVNS device optimization .
  • The company secured multiple financing sources: a $25M equity line of credit, an $8.4M strategic purchase agreement, and raised $1.7M net proceeds under its ATM post-quarter, with no debt; management believes liquidity is sufficient through GMP validation and upcoming VNS data readouts .
  • Biopharma catalysts advanced: Tivic entered a GMP manufacturing validation agreement (valued at ~$4.1M) with Scorpius for Entolimod ahead of a BLA filing; Entolimod has FDA Fast Track and Orphan Drug status for ARS, with positive signals from recent White House/FDA briefings on expedited pathways and military/defense applications .
  • Device pipeline catalysts: ncVNS optimization study expanded based on positive signals; full data readouts expected over the summer, with the program aiming to deliver clinically validated, non-invasive alternatives to implanted VNS systems .
  • No Wall Street EPS/Revenue consensus was available to benchmark Q1 results. Expect estimates to adjust toward lower DTC revenue near-term, with attention shifting to biopharma readiness and ncVNS trial milestones (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • “Defining time for the company”: Strategic pivot executed—exclusive worldwide licensing of Entolimod/Entolasta and initiation of manufacturing validation; FDA Fast Track/Orphan Drug for ARS and constructive briefings with senior leadership at the White House and FDA on expedited pathways .
  • Financing runway: $25M equity line, $8.4M purchase agreement, and $1.7M raised via ATM post-quarter; no balance sheet debt—management expects this to fund GMP validation and VNS readouts .
  • Margin improvement: Q1 gross margin expanded to 72% as product support/fulfillment costs fell, despite sales reductions; gross profit was $0.05M .

What Went Wrong

  • Revenue compression: Q1 revenue fell to $0.07M (from $0.334M YoY) due to a deliberate 92% reduction in advertising and an 81% decrease in unit sales of ClearUP; management deprioritized DTC near-term to reallocate capital .
  • Cash declined during quarter: cash and equivalents fell to $0.669M at March 31, 2025 (from $2.0M at year-end), necessitating reliance on post-quarter financing actions .
  • Limited quantitative guidance: No explicit ranges for revenue, margins, or OpEx were provided, increasing uncertainty on near-term DTC contribution; investors must anchor on pipeline milestones rather than near-term financial guideposts .

Financial Results

MetricQ1 2024Q3 2024Q4 2024Q1 2025
Revenue ($USD)$0.334M $0.126M $0.180M $0.070M
Gross Profit ($USD)$0.167M $0.044M $(0.239M)*$0.050M
Gross Margin %50.0% 35.0% (132.8%)*72.0%
Total Operating Expenses ($USD)$1.648M $1.476M $1.723M*$1.556M
Net Income (Loss) ($USD)$(1.481M) $(1.431M) $(1.477M)*$(1.502M)
Diluted EPS ($USD)$(17.15) $(0.23) $(3.20)*$(2.52)
Cash & Equivalents ($USD)—$2.189M $2.002M $0.669M

Notes: Asterisk denotes values retrieved from S&P Global without document citations. Values retrieved from S&P Global.

Segment breakdown: Not applicable; revenue primarily from ClearUP device (no segment reporting) .

KPIs and Balance Sheet

KPIQ1 2025Context
Working Capital ($USD)$0.520M As of March 31, 2025
Advertising Spend Change(92%) Strategic reallocation (biopharma/VNS)
Unit Sales Change(81%) Lower ClearUP units due to ad reductions
Financing$25M ELOC; $8.4M purchase agreement; $1.7M ATM post-Q1 Liquidity for GMP & ncVNS execution
Debt$0 No debt on balance sheet

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY 2025Not providedNot providedMaintained (no quantitative guidance)
Gross MarginFY 2025Not providedNot providedMaintained (no quantitative guidance)
Operating ExpensesFY 2025Not providedPlan to increase R&D in ncVNS and TLR5 programs (directional only) Directional increase (no numeric range)
Biopharma milestones2025–2026Not providedGMP validation underway; post-validation bioequivalence and 1-year stability prior to BLA filing New milestones articulated
ncVNS milestonesSummer 2025Not providedFull optimization study readout expected over the summer; pursue disease-specific trials later in 2025 New milestones articulated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
ncVNS R&D executionPhase I showed strong autonomic/cardiac/neurologic effects; optimization study enrollment completed; margins improved post supply-chain redesign Optimization study expanded; readout expected over the summer; emphasis on personalization and IP expansion Positive momentum; approaching data catalysts
Supply chain & gross marginSupply chain redesign completed; onetime costs in Q3; post-transition gross margin >70% for ClearUP Gross margin 72% in Q1; support/fulfillment costs reduced Sustained margin improvement
Regulatory/militaryNoneWhite House/FDA briefings indicated positive interest; expedited pathways for Entolimod/Entolasta; defense community interest including PTSD for ncVNS Accelerating regulatory engagement
Biopharma pipeline (Entolimod/Entolasta)License announced in Feb 2025; ARS focus with prior gov funding; plan for GMP/BLA; multi-indication options (neutropenia, immunosenescence, lymphocyte exhaustion) GMP validation agreement signed; neutropenia Phase II option exercised; FDA Fast Track & Orphan Drug reiterated Advancing toward commercialization steps
Financing/liquidityATM usage; cash $2.2M at 9/30/24; ELOC and capital planning $25M ELOC; $8.4M agreement; $1.7M ATM; cash $0.669M at quarter-end; no debt Liquidity bolstered; funding aligned to milestones
Nasdaq complianceReverse split planned/executed; intent to regain compliance Regained compliance with minimum bid price rule Completed

Management Commentary

  • CEO on strategic pivot: “This is a defining time for the company… we initiated a significant strategic shift, dramatically expanding Tivic's clinical pipeline for restoring immune system health” .
  • COO/President Biopharma on Entolimod efficacy: A single injection 25 hours after lethal radiation improved survival nearly threefold in nonhuman primates; 75% survival vs. 27.5% placebo at 60 days; human safety data across >230 subjects; transient adverse effects observed .
  • CEO on regulatory path: “Once the manufacturing process is validated, we will then need to secure bioequivalency data and 1 year of stability data before filing the complete BLA with the FDA” .
  • CFO on capital: “We believe these funds… will be sufficient to fund the company through GMP manufacturing validation for Entolimod, a key value inflection point” .

Q&A Highlights

  • ClearUP prioritization: Management is allowing ClearUP to grow organically, exploring alternative monetization (licensing/white labeling), while capital is focused on higher-value ncVNS indications .
  • VNS resourcing & funding: Team expects to expand clinical resources and use a mix of nondilutive grants, selective ATM usage, and partnerships to progress into Phase II/III; payer/provider feedback on indications is “strongly positive” per market work with FSI .
  • Note: The Q1 2025 call was pre-recorded and primarily prepared remarks; guidance clarifications occurred via CFO commentary on financing/milestones rather than numeric ranges .

Estimates Context

  • S&P Global Wall Street consensus for Q1 2025 EPS and Revenue was unavailable, preventing beat/miss analysis versus consensus. Expect analysts to adjust near-term revenue assumptions lower given deliberate ad reductions and to focus on biopharma/ncVNS milestone timing (S&P Global data unavailable).

Key Takeaways for Investors

  • Near-term DTC revenue is intentionally compressed while margins improved; investors should reframe the story around biopharma and ncVNS milestones rather than quarterly sales growth .
  • Liquidity appears adequate to reach key value inflection points (Entolimod GMP validation; ncVNS optimization readouts), supported by $25M ELOC, $8.4M purchase agreement, and ATM proceeds; no debt reduces execution risk .
  • Entolimod’s ARS profile (Fast Track/Orphan, robust nonhuman primate efficacy, complementary human safety) plus White House/FDA engagement supports potential expedited pathways and biodefense stockpile demand .
  • The ncVNS program is positioned to deliver differentiated, personalized, non-invasive neuromodulation, with summer data readouts and disease-specific trials targeted later in 2025—catalysts for sentiment .
  • Cash dipped to $0.669M at quarter-end, but post-quarter financings mitigated; monitor execution against GMP milestones and the timing of ELOC drawdowns .
  • Absence of quantitative guidance and limited consensus coverage increases headline uncertainty; price action likely to be driven by regulatory/manufacturing updates, ncVNS data quality, and financing cadence .
  • Strategic narrative is shifting from a single OTC device to a diversified immunotherapeutics platform; relative valuation may re-rate on credible progress toward BLA and clinical device endpoints .