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Tonix Pharmaceuticals Holding Corp. (TNXP)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results missed Wall Street consensus: revenue $2.58M vs $3.35M consensus (miss $0.77M) and GAAP EPS $(9.77) vs $(6.23) consensus (miss $(3.54)); gross margin expanded sequentially to ~54% on lower cost of sales. Values retrieved from S&P Global for consensus; reported figures from company press release [S&P Global].
  • Cash and equivalents were $98.8M at December 31, 2024; management guided runway beyond the August 15, 2025 PDUFA date and into Q1 2026, and the company noted it is now debt-free following a February 2025 mortgage repayment .
  • Regulatory progress continued: FDA accepted the TNX-102 SL NDA (Dec 17) and assigned an Aug 15, 2025 PDUFA goal date (Dec 23); Tonix is preparing for a potential Q4 2025 fibromyalgia launch contingent on approval .
  • R&D spend fell YoY due to pipeline prioritization; SG&A rose on TNX-102 SL NDA-related costs and commercial build-out. Net product revenue softened YoY (migraine brands Zembrace/Tosymra), but gross margin improved QoQ as Q2 inventory write-downs did not repeat .
  • Additional potential catalysts: TNX-1500 Phase 1 topline positive (Feb 2025) supporting monthly dosing in planned Phase 2; mpox program TNX-801 advanced with WHO-aligned profile and new grant; DoD antiviral program TNX-4200 received initial payments and AI/ML collaboration with X-Chem .

What Went Well and What Went Wrong

What Went Well

  • Regulatory de-risking: FDA accepted the TNX-102 SL NDA and set an Aug 15, 2025 PDUFA date; CEO: “we believe we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of this year if approved” .
  • Balance sheet strength: $98.8M year-end cash; runway into Q1 2026; “Tonix is debt free” post-February 2025 repayment .
  • Pipeline momentum: TNX-1500 Phase 1 met objectives with favorable safety and 34–38 day half-life supporting monthly dosing; TNX-801 gained grant support and demonstrated single-dose protective efficacy in preclinical models .

What Went Wrong

  • Top-line miss and YoY decline: Q4 product revenue $2.58M vs $3.78M YoY; revenue missed consensus ($3.35M*) [S&P Global].
  • EPS miss: GAAP loss per share $(9.77) vs $(6.23) consensus*, reflecting higher SG&A tied to NDA submission and commercial prep; consensus coverage is thin (EPS estimates count = 1*) [S&P Global].
  • Prior-quarter headwind: Q2 included a ~$58.96M non-cash asset impairment for the migraine brands driven by delayed sales investment—depressing year-to-date profitability; though not repeated in Q4, it elevated full-year loss metrics .

Financial Results

Quarterly Financials vs Prior Periods

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Net Product Revenue ($USD Millions)$3.779 $2.208 $2.822 $2.582
Cost of Revenue ($USD Millions)$2.367 $3.367 $1.555 $1.183
Gross Profit ($USD Millions)$1.412 -$1.159 $1.267 $1.399
Gross Margin %37.4% -52.5% 44.9% 54.2%
R&D Expense ($USD Millions)$17.120 $9.698 $9.114 $8.297
SG&A Expense ($USD Millions)$11.621 $7.502 $7.707 $15.582
GAAP Net Loss ($USD Millions)$(27.322) $(78.776) $(14.213) $(22.108)
GAAP EPS (Basic & Diluted, $)$(2,179.83) $(19.28) $(0.23) $(9.77)
Weighted Avg Shares (Basic & Diluted)12,534 4,085,132 62,122,283 2,263,535

Notes: Gross profit and margin are derived from reported revenue and cost of revenue (citations provided).

Estimates vs Reported (Q4 2024)

MetricConsensus (S&P Global)*Reported
Revenue ($USD)$3,350,000*$2,582,000
Primary EPS ($)$(6.23)*$(9.77)

Values retrieved from S&P Global. Coverage counts: EPS estimates = 1*, Revenue estimates = 2*.

Balance Sheet and Cash KPIs

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Cash & Equivalents ($USD Millions)$24.948 $4.156 $28.233 $98.776
Total Assets ($USD Millions)$154.457 $70.307 $94.989 $162.890
Total Liabilities ($USD Millions)$48.932 $28.204 $20.778 $23.332
Stockholders’ Equity ($USD Millions)$105.525 $42.103 $74.211 $139.558

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
TNX-102 SL regulatory timeline2025FDA acceptance pending (Q3 commentary); PDUFA date expected in December NDA accepted (Dec 17); PDUFA goal date Aug 15, 2025; potential Q4 2025 launch if approved Raised visibility; timeline set
Cash runwayThrough launch“Sufficient cash to fund operations through PDUFA target date and anticipated Q4 2025 launch” “Sufficient to fund into Q1 2026,” including ~$46.3M ATM proceeds in Q1 2025 Extended
Capital structureN/AMortgage outstanding in 2024“Following repayment… in Feb 2025, the Company is now debt-free” Improved
Share repurchaseN/AN/A250,000 shares repurchased under 2024 program (post year-end) Initiated

No formal revenue/EPS/OpEx guidance was provided in Q4 materials .

Earnings Call Themes & Trends

Note: No published Q4 2024 earnings call transcript was found in the document catalog or via public internet sources; the press release indicates the report date and financial details. MarketBeat lists a call scheduling detail (Mar 18, 2025, 4:00 PM ET) but no transcript was available .

TopicPrevious Mentions (Q2, Q3)Current Period (Q4 2024)Trend
Regulatory (TNX-102 SL)Pre-NDA alignment with FDA; Fast Track granted; NDA submission (Oct 2024) NDA accepted (Dec 17) and PDUFA date set (Dec 23); active FDA engagement; launch prep underway Progressing; de-risking
R&D execution (TNX-1500)Phase 1 clinical stage completed; PK modeling supports monthly dosing Positive Phase 1 topline: 34–38 day half-life; monthly dosing supported; favorable safety Advancing to Phase 2
Infectious disease (TNX-801)WHO PHEIC context; manufacturing collaboration; vaccine data presented Grant award; KEMRI sponsored research; tolerability publication; alignment with WHO TPP Building validation
Broad-spectrum antivirals (TNX-4200)DoD/DTRA $34M OTA award First payments received; AI/ML collaboration with X-Chem to accelerate discovery Funded; accelerated
Commercialization prepEVERSANA market assessment; physician intent to use TNX-102 SL (40%) Added marketing, medical affairs, market access leadership; expanded commercial team Scaling go-to-market
Marketed products performanceQ2 inventory write-down impacted margins; Q3 stabilization Q4 revenue down YoY; cost of sales reduced; gross margin improved QoQ Stabilizing margins

Management Commentary

  • CEO Seth Lederman: “we believe we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of this year if approved by the U.S. Food and Drug Administration” .
  • CEO on balance sheet: “Tonix is debt free and expects to have sufficient cash to fund operations through the PDUFA target date… and the anticipated commercial launch” .
  • On TNX-1500: “All objectives were met and support proceeding to a Phase 2 trial… mean half-life of 34–38 days… generally well-tolerated with a favorable safety profile” .

Q&A Highlights

  • No Q4 earnings call transcript was available; the press release provides clarifications on cash runway, debt status, and launch preparations . MarketBeat listed a call time for Mar 18, 2025, but no transcript text was accessible .

Estimates Context

  • Q4 2024 outcome vs consensus: revenue $2.58M vs $3.35M consensus*; GAAP EPS $(9.77) vs $(6.23) consensus*; both misses likely driven by softer migraine brand sales and elevated SG&A tied to NDA/commercial prep [S&P Global].
  • Coverage is limited (EPS estimates count = 1*, revenue estimates count = 2*), suggesting future estimate dispersion may widen as TNX-102 SL progresses toward potential approval and commercialization [S&P Global].

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory timeline is firm: NDA accepted and PDUFA set for Aug 15, 2025; launch prep in Q4 2025 positions TNXP for a potential new class entrant in fibromyalgia if approved .
  • Liquidity improved materially ($98.8M YE cash); runway into Q1 2026 and debt-free status reduce near-term financing risk ahead of PDUFA .
  • Near-term financials: Q4 miss vs consensus on both revenue and EPS, but gross margin expanded QoQ (~54%) absent Q2 inventory charges—watch for continued margin stabilization in marketed migraine brands .
  • Pipeline optionality: TNX-1500 positive Phase 1 supports Phase 2 monthly dosing; TNX-801 is aligned with WHO TPP and received a new grant; TNX-4200 is funded by DoD and AI-collaboration may accelerate lead optimization .
  • Estimate revisions: Expect Street models to reflect higher SG&A into PDUFA and potentially re-base revenue for migraine brands; upside hinges on TNX-102 SL approval and launch trajectory [S&P Global].
  • Trading implications: Regulatory milestones (any FDA communications pre-PDUFA) and commercial build-out updates are key stock catalysts; balance sheet strength may mitigate dilution risk near term .
  • Medium-term thesis: If approved, TNX-102 SL could address a large unmet need in fibromyalgia with non-opioid profile; watch payer/access strategy and initial launch metrics given physician dissatisfaction with current options .