Sign in

You're signed outSign in or to get full access.

TH

Tivic Health Systems, Inc. (TIVC)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 capped a transformational period: Tivic reported FY24 revenue of $0.78M (down YoY with inventory reserves depressing FY gross profit) and unveiled a new biopharma pillar via the exclusive license to TLR5 agonist Entolimod for ARS while advancing its personalized non-invasive VNS program .
  • Operations tightened materially: FY net loss narrowed 30% YoY to $5.7M; OpEx fell to $5.7M from $8.5M; year-end cash was $2.0M with $2.4M working capital .
  • Financing flexibility improved: a $25M equity line of credit with Mast Hill was executed (95% of VWAP pricing; 4.99% ownership blocker; 19.99% exchange cap without shareholder approval), alongside a 1-for-17 reverse split to regain Nasdaq compliance .
  • Near-term catalysts: Entolimod manufacturing validation initiating toward an estimated ~18-month BLA path and potential first orders in ~2 years; VNS optimization data readout and initiation of disease-specific trials later in 2025; expanding IP estate .

What Went Well and What Went Wrong

What Went Well

  • Strategic pivot to diversified therapeutics: Exclusive license to late-stage TLR5 agonist Entolimod for ARS plus optioned follow-on indications and second-gen molecule (Entolasta), led by former Statera CEO Michael Handley as COO/President of Tivic Biopharma .
  • VNS platform momentum: Personalization of ncVNS showed up to a 400% increase in autonomic effects; optimization study enrollment completed with positive interim signals and data readout expected before moving to disease-specific trials in 2025 .
  • Cost discipline and liquidity: FY24 OpEx cut by ~$2.9M YoY; year-end cash of $2.0M; new $25M equity line to flexibly fund programs; Nasdaq compliance plan advanced with a 1-for-17 split and 10 days above minimum bid price by Mar 21 .

Selected management quotes:

  • “This represents…a diversified therapeutics company, with multiple shots on goal.”
  • “Personalizing the vagus nerve stimulation…offered a 400% increase in the effects that we saw.”
  • “We…fully expect to be hearing from NASDAQ soon that we are in compliance…”

What Went Wrong

  • Revenue decline and inventory clean-up: FY24 revenue fell to $0.78M (from $1.18M) driven by a 41% unit decline amid reduced marketing; inventory reserves of $354k plus disposal costs reduced FY gross profit to $2k .
  • Q4 gross margin headwind: Q4 gross profit negative due to inventory reserve actions; quarterly fundamentals reflect the transition year (see tables) .
  • Limited external estimate coverage: No S&P Global consensus EPS available; revenue consensus not populated—limits traditional “beat/miss” framing this quarter.*

Financial Results

Quarterly trends (Q2–Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($)$140,000*$126,000 $180,000*
Net Income ($)$(1,266,000)*$(1,431,000) $(1,477,000)*
Diluted EPS (Continuing Ops)$(5.37)*$(0.23) $(3.20)*
Gross Profit ($)$30,000 $44,000 $(239,000)*
Gross Margin (%)21.4%*34.9%*(132.8%)*
Total Operating Expenses ($)$1,236,000 $1,475,000 $1,723,000*

Notes: Values marked with * retrieved from S&P Global.

Full-year comparison (FY 2024 vs FY 2023)

MetricFY 2023FY 2024YoY
Revenue ($)$1,176,000 $780,000 (33.7%)
Gross Profit ($)$287,000 $2,000 (99.3%)
Total Operating Expenses ($)$8,532,000 $5,663,000 (33.6%)
Net Loss ($)$(8,244,000) $(5,655,000) +$2.59M
Cash & Equivalents (12/31) ($)$3,395,000 $2,002,000 (41.0%)
Working Capital (12/31) ($)—$2,400,000 —

KPIs (cash and margins trajectory)

KPIQ2 2024Q3 2024Q4 2024
Cash & Equivalents ($)$3,693,000 $2,189,000 $2,002,000
Gross Margin (%)21.4%*34.9%*(132.8%)*
Working Capital ($)——$2,400,000

Notes: Values marked with * retrieved from S&P Global.

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent Guidance/UpdateChange
ncVNS optimization studyQ4’24→Q1’25Enrollment complete; study to complete early Q1’25 Data package completion and reporting expected during 2025; informs disease-specific trials Maintained timeline; expanded personalization insights
Disease-specific ncVNS trials2025Begin Phase 2 in 1H’25 (Q3 call) “Move into disease-specific clinical trials…later this year (2025)” Slightly refined timing (later in 2025)
Entolimod (TLR5) for ARS~18 months to BLAN/AManufacturing validation commencement; bioequiv testing; target BLA submission in ~18 months; potential first orders ~2 years New timeline provided
OpEx/R&D mix2025Cost reductions emphasized in 2024 Plan to increase R&D in VNS and TLR5 programs Increased R&D investment planned
Capital/Listing2025ATM usage (Q3) $25M equity line executed; 1-for-17 split; 10 consecutive days above bid minimum as of Mar 21 Liquidity enhanced; listing compliance strengthened

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2, Q3)Current Period (Q4 2024)Trend
ncVNS clinical efficacy and personalizationPhase 1 showed “best-in-industry” physiological effects; optimization study launched/enrollment completed Personalization delivered ~400% increase in autonomic impact; optimization data expected to guide 2025 trials Strengthening
Commercial ClearUP and marginsSupply chain redesign; ClearUP 2.0; post-transition gross margin “upwards of 70%” net of one-time costs FY inventory reserve ($354k) depressed FY gross profit; logistics switch improving recurring margins Core margin improving; accounting clean-up in FY
Capital and liquidityATM utilized; cash $3.7M (Q2); $2.2M (Q3) $25M equity line; year-end cash $2.0M; reverse split and bid price compliance Improved flexibility
Biopharma strategy (TLR5/Entolimod)N/AExclusive license; ~18-month BLA path; target stockpiling markets (BARDA/DoD history) New growth pillar
IP/RegulatoryExpanding patents; European validations (Q4) 27 total issued/pending; >60 licensed patents from Statera for TLR5 assets Expanding portfolio
Nasdaq listingWatch status1-for-17 split; 10 days above minimum bid by Mar 21 Stabilizing

Management Commentary

  • “We have successfully reshaped the company…by in-licensing a late-stage biologic immunotherapy and advancing our…ncVNS devices.”
  • “By adding a newly licensed TLR5 agonist…this gives us a late-stage drug candidate for treating acute radiation syndrome…foundation for building a biopharmaceutical capacity.”
  • “Our data showed that personalizing the vagus nerve stimulation…offered a 400% increase in the effects…”
  • “Our next step is to move into manufacturing validation…then…a BLA…This particular asset has been significantly de-risked.”
  • “We traded above $1 for ten consecutive days and…expect…Nasdaq…compliance.”

Q&A Highlights

  • Call format: prerecorded remarks; no live Q&A session; operator noted pre-submitted questions to be addressed following remarks .
  • Funding and runway: Introduced a $25M equity line (95% VWAP pricing; 4.99% blocker; 19.99% cap), providing flexible, staged access to capital for VNS and Entolimod programs .
  • Timelines: ncVNS to proceed into disease-specific trials later in 2025; Entolimod to commence manufacturing validation aiming for BLA submission in ~18 months and potential first orders in ~2 years .
  • Listing/compliance: 1-for-17 reverse split implemented; 10 consecutive days above minimum bid as of Mar 21 cited as a milestone toward compliance .

Estimates Context

  • S&P Global consensus coverage: No consensus EPS available for Q4 2024; revenue consensus not populated. Results are thus presented versus prior quarter and prior year rather than “beat/miss” versus Street.*
  • Actuals captured below:
MetricQ4 2024 Actual
Revenue ($)$180,000*
Primary EPS (Continuing Ops)$(3.20)*

Notes: Values marked with * retrieved from S&P Global.

Implications: Absence of formal Street coverage means estimate revisions are unlikely to drive near-term trading; catalysts will skew to clinical/regulatory milestones, liquidity actions, and listing status updates.

Key Takeaways for Investors

  • The investment narrative has shifted to a dual engine: bioelectronics (personalized ncVNS) plus biopharma (Entolimod/Entolasta) targeting immune dysregulation, expanding TAM and potential funding/partnering avenues .
  • 2025 is execution-heavy: ncVNS optimization data, initiation of disease-specific trials, and Entolimod manufacturing validation toward a BLA; these are the likely stock catalysts over the next 6–18 months .
  • Liquidity improved with a $25M equity line, but share issuance is gated by a 19.99% exchange cap absent shareholder approval; expect program pacing to align with financing windows and market conditions .
  • FY24 financial clean-up (inventory reserves, logistics shift) likely obscures underlying margin improvement trajectory in D2C ClearUP; recurring margin benefits should be more visible post-reserve period .
  • Listing risk abated with reverse split and improved bid compliance; maintaining Nasdaq status reduces financing friction and broadens investor access .
  • Valuation sensitivity will hinge on de-risking milestones: VNS clinical efficacy in target indications and clarity on Entolimod’s regulatory path/stockpiling demand (BARDA/DoD precedent) .
  • Watch IP expansion and partnership optionality as potential non-dilutive value levers (27 issued/pending; >60 licensed patents for TLR5 portfolio) .

Additional source materials for prior quarters and Q4-related releases:

  • Q3 2024 results PR and transcript: revenue $126k; OpEx $1.5M; margin commentary; strategy updates -.
  • Q2 2024 results PR: revenue $140k; gross profit $30k; cost actions; Phase 1 ncVNS data -.
  • Q4 operational press releases: ncVNS optimization enrollment complete (Feinstein) ; CEO shareholder letter (Dec 23) -.
  • Q4 earnings press release and 8-K/exhibit: FY24 financials and strategic overview; $25M equity line; reverse split - -.

Footnote: Values marked with * retrieved from S&P Global.