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Vivani Medical, Inc. (VANI)·Q4 2024 Earnings Summary

Executive Summary

  • Vivani reported Q4 2024 results with no product revenue and a net loss of $6.05M ($0.11 per share); R&D was $4.30M and G&A was $2.16M .
  • Operationally, the company successfully initiated and fully enrolled LIBERATE-1 (first-in-human NPM-115 exenatide implant study) and remains on track for mid-2025 top-line data—management emphasized each implantation to date has been successful .
  • Financing extended runway: an $8.25M equity raise announced March 27, 2025 supported runway into Q2 2026; subsequent $3M insider financing on May 12, 2025 indicated “mid-2026” runway .
  • Strategic update: Cortigent separation path changed from an IPO (S-1) plan to a Form 10 spin-off filing to create two focused public companies, pending listing, regulatory, and financing milestones .

What Went Well and What Went Wrong

  • What Went Well

    • First-in-human execution: “each implantation to date [in LIBERATE-1] having been successful,” with top-line mid-2025; management said the study will “provide key performance data on drug release” informing NPM-139 as well .
    • Pipeline momentum: positive preclinical weight-loss data for NPM-139 (semaglutide implant) comparable to semaglutide injections; Vivani will advance NPM-139 toward clinical development alongside NPM-115 .
    • Balance sheet support: $8.25M equity financing (3/27/25) securing runway into Q2 2026; management is fitting out the Alameda facility to support large-scale clinical and future commercial supply .

  • What Went Wrong

    • Still pre-revenue with recurring losses: Q4 2024 net loss of $6.05M and FY 2024 net loss of $23.49M; no product revenue reported .
    • Q4 operating expense mix: G&A rose 43% YoY to $2.16M (vs. $1.51M), offset by R&D down 9% YoY to $4.30M; overall Opex rose slightly vs Q4’23 .
    • Estimates/data scarcity: No S&P Global consensus for Q4 2024 revenue/EPS; limited external benchmarks imply higher volatility around catalysts and valuation absent near-term revenue visibility (S&P Global estimates unavailable via GetEstimates).

Financial Results

Quarterly comparison (oldest → newest) and YoY where available.

MetricQ2 2024Q3 2024Q4 2024Q4 2023
Revenue ($USD Millions)$0.00 (no revenue line reported) $0.00 (no revenue line reported) $0.00 (no revenue line reported) $0.00 (no revenue line reported)
Research & Development ($M)$3.51 $4.20 $4.30 $4.71
General & Administrative ($M)$2.17 $2.11 $2.16 $1.51
Total Operating Expenses ($M)$5.68 $6.31 $6.46 $6.22
Other Income (Expense), Net ($M)$0.33 $0.27 $0.41 $0.19
Net Income (Loss) ($M)$(5.36) $(6.04) $(6.05) $(6.03)
Diluted EPS ($)$(0.10) $(0.11) $(0.11) $(0.12)
Net Margin (%)N/M (pre-revenue) N/M (pre-revenue) N/M (pre-revenue) N/M (pre-revenue)
Cash, Cash Equivalents and Restricted Cash ($M)$26.26 (6/30/24: $24.92 cash + $1.34 restricted) $20.98 (9/30/24: $19.65 cash + $1.34 restricted) $19.69 (12/31/24: $18.35 cash + $1.34 restricted) $21.99 (12/31/23: $20.65 cash + $1.34 restricted)

Notes: N/M = not meaningful due to no revenue reported (statements presented without a revenue line) .

KPIs (operational and balance sheet)

KPIQ2 2024Q3 2024Q4 2024
Weighted Avg Shares (basic & diluted, millions)55.02 55.25 57.42
Total Assets ($M)$48.22 $42.90 $41.56
Total Liabilities ($M)$24.40 $24.56 $23.95
Stockholders’ Equity ($M)$23.82 $18.33 $17.61

Segment breakdown: Not applicable; the company reports as a single segment with the Cortigent unit consolidated in 2024 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q4 2024 releaseInto Q2 2026 (after $8.25M raise announced Mar 27, 2025) Into mid-2026 (after additional $3M insider financing announced May 12, 2025) Slight extension (maintained/extended)
Cortigent Separation Path2025Initial plan via S-1 IPO Revised to Form 10 spin-off filing to create an independent public company (subject to listing, regulatory, and financing) Strategy revised
Revenue, Margins, OpEx, OI&E, Tax, Dividends2025None provided None provided N/A

No quantitative revenue/EPS guidance was issued in the Q4 release .

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available in our document set (none found) and themes are derived from press releases and investor materials.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
NPM-115 (exenatide implant) clinical progressQ2’24: IND cleared for related NPM-119; plan to start LIBERATE-1 in 4Q24 . Q3’24: reiterated near-term milestones, preclinical support .Successful initial administrations; full enrollment achieved; on track for mid-2025 top-line .Positive execution momentum
NPM-139 (semaglutide implant)Q3’24: pipeline positioning; preclinical work ongoing .Positive preclinical weight-loss data; accelerating toward clinical development .Accelerating
Financing & runwayQ3’24 deck noted $5M private sale on Nov 8, 2024 .$8.25M raise (3/27/25) → runway into Q2’26; May 12 insider $3M → mid-2026 .Improved liquidity
Manufacturing readinessLimited prior detail.Equipping Alameda facility for large-scale clinical and eventual commercial supply .Building capability
Cortigent separationQ3’24 background content on Cortigent .Path revised from IPO to Form 10 spin-off .Strategy refined
Regulatory strategyQ2’24: NPM-119 IND cleared, 505(b)(2) pathway indicated for exenatide .LIBERATE-1 execution in obese/overweight; NPM-139 path discussed .Advancing

Management Commentary

  • “During 2024, we transitioned Vivani to a clinical-stage biotechnology company… Our first-in-human LIBERATE-1 study continues to progress as planned with each implantation to date having been successful and we remain on track for top-line data in mid-2025.” — Adam Mendelsohn, Ph.D., CEO .
  • “By providing key performance data on drug release, the value of LIBERATE-1 extends beyond the NPM-115 program by also informing the NPM-139 program as it advances in parallel.” .
  • “In March, we raised funding to support operations into the second quarter of 2026. Additionally, we continue to equip our dedicated facility in Alameda, California, to support the manufacturing of large-scale clinical trial materials and, ultimately, commercial supply.” .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in our records to extract Q&A; management clarifications and tone are taken from the press release and slides .

Estimates Context

  • S&P Global consensus for Q4 2024 revenue and EPS was unavailable via our estimates query (no values returned). Values retrieved from S&P Global.
  • As a pre-revenue company with no product sales reported in Q4 2024, traditional beat/miss framing vs. Street was not applicable this quarter .

Key Takeaways for Investors

  • Near-term catalyst: mid-2025 LIBERATE-1 top-line in obese/overweight patients is the key value inflection; successful insertions and full enrollment de-risk execution timelines .
  • Dual-track obesity strategy: positive NPM-139 preclinical data supports moving semaglutide implant toward the clinic alongside NPM-115, expanding the potential GLP-1 implant franchise .
  • Liquidity extended: $8.25M raise announced March 27, 2025 (runway into Q2 2026) and $3M insider financing on May 12, 2025 (to mid-2026) reduce near-term financing risk while clinical catalysts approach .
  • Manufacturing scale-up underway: investment in the Alameda facility positions Vivani for larger clinical material production and potential commercial supply if programs advance .
  • Strategic focus sharpened: revising Cortigent’s separation to a Form 10 spin-off aims to unlock value and focus Vivani on GLP-1 implants; execution depends on listing, regulatory and financing conditions .
  • Risk profile remains biotech-typical: no revenue, continuing losses (Q4 net loss $6.05M; FY24 net loss $23.49M) and reliance on successful trial outcomes and capital markets .
  • Trading implications: Expect heightened sensitivity to LIBERATE-1 updates and NPM-139 clinical start timing; financing cadence and spin-off milestones could also be stock catalysts in the interim .

Supporting detail and additional context

  • Prior Quarter Trends: Q2→Q3→Q4 shows Opex rising with clinical execution (Total Opex $5.68M → $6.31M → $6.46M), and steady quarterly net losses around $5.36–$6.05M as the company transitions into the clinic .
  • Cash Bridge: Cash and equivalents trended from $24.92M (6/30/24) to $19.65M (9/30/24) to $18.35M (12/31/24), excluding $1.34M restricted cash; subsequent financings extend runway beyond Q2 2026/mid-2026 .

Sources: Q4 2024 press release and audited financials (Form 8-K filed Mar 31, 2025) ; Q3 2024 investor slides (Nov 13, 2024) ; Q2 2024 press release and financials (Aug 13, 2024) ; May 13, 2025 business update and Q1 2025 results with $3M financing .