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Citius Pharmaceuticals, Inc. (CTXR)·Q4 2024 Earnings Summary

Executive Summary

  • FY24 ended with no revenue and a wider annual net loss: $(39.4M), or $(5.97) EPS, driven by higher G&A and stock-based comp; cash fell to $3.3M at year-end, with new inventory ($8.27M) and license payable ($28.4M) reflecting commercialization prep for LYMPHIR .
  • Strategic milestones: FDA approval of LYMPHIR in August, constructive FDA Type C meeting outlining an NDA path for Mino-Lok, and completion of the oncology spin-off (CTOR), positioning 2025 as an execution year .
  • Management targets LYMPHIR launch in H1 2025 and expects R&D to decrease in FY25; it also plans to distribute CTOR shares to Citius Pharma shareholders by year-end 2025, pending market conditions .
  • Financing and listing actions: reverse stock split (1-for-25) to regain Nasdaq bid-price compliance and stated intent to raise additional capital to fund operations—key stock catalysts alongside the commercial launch timeline .

What Went Well and What Went Wrong

  • What Went Well

    • FDA approval of LYMPHIR for relapsed/refractory CTCL; management emphasized it as the first FDA-approved product and a portfolio inflection point .
    • Mino-Lok Phase 3 met primary and secondary endpoints; FDA Type C meeting provided clear, actionable guidance on a pathway to NDA submission .
    • Spin-off executed: Citius Oncology began trading as CTOR; plan to distribute CTOR shares to CTXR holders in 2025, broadening investor access for the oncology asset .
    • Quote: “It was a transformative year, marked by our first FDA approval and significant clinical milestones… exploring strategic partnerships and licensing opportunities to maximize the potential of our portfolio” — Leonard Mazur, CEO .

  • What Went Wrong

    • Liquidity tightened: year-end cash fell to $3.25M from $26.48M a year ago; management expects to raise additional capital to support operations .
    • Annual net loss widened to $(39.4M); G&A rose to $18.2M and stock-based comp to $11.8M, diluting EPS to $(5.97) vs $(5.57) in FY23 .
    • Share count/communications inconsistency in Q3 narrative vs table (158.9M vs 180.7M outstanding at June 30) suggests a disclosure discrepancy to monitor for future reporting clarity .

Financial Results

  • FY results versus prior year
MetricFY 2023FY 2024
Revenue ($USD Millions)$0.0 $0.0
Operating Loss ($USD Millions)$(36.7) $(42.0)
Net Loss ($USD Millions)$(32.5) $(39.4)
EPS ($USD)$(5.57) $(5.97)
G&A Expense ($USD Millions)$15.3 $18.2
Stock-based Comp ($USD Millions)$6.6 $11.8
  • Quarterly P&L progression (company did not disclose standalone Q4 quarterly P&L; Q1–Q3 shown)
MetricQ1 2024Q2 2024Q3 2024Q4 2024
Operating Loss ($USD Millions)$(9.34) $(10.97) $(10.63) Not disclosed (annual only)
Net Loss ($USD Millions)$(9.23) $(8.54) $(10.57) Not disclosed (annual only)
EPS ($USD)$(0.06) $(0.05) $(0.06) Not disclosed (annual only)
  • KPIs and balance sheet items
KPIQ1 2024Q2 2024Q3 2024FY 2024
Cash & Equivalents ($USD Millions)$20.35 $12.56 $17.91 $3.25
Shares Outstanding (period-end)158,966,576 159,094,781 180,725,407 (table); 158,857,798 (narrative) 7,247,243 (post 1-for-25)
Inventory ($USD Millions)———$8.27
License Payable ($USD Millions)———$28.4
Deferred Tax Liability ($USD Millions)$6.28 $6.43 $6.57 $6.71

Note: Q4 standalone metrics were not disclosed; the company provided annual statements only .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
LYMPHIR launch timingH1 2025N/A (pre-approval, pre-launch)Launch targeted in H1 2025 via majority-owned CTOR subsidiary New timing (operational)
R&D expensesFY 2025Stabilize at FY24 levels (earlier commentary) Expected to decrease as commercialization focus increases and Mino-Lok Phase 3 completed Lowered
Capital actionsFY 2025Cash runway through Dec 2024; seek additional capital Expects to raise additional capital to support operations Maintained (explicit)
CTOR share distributionFY 2025CTOR listed Aug 2024 Plan to distribute CTOR shares to CTXR shareholders by year-end 2025, subject to market conditions New shareholder action
Mino-Lok regulatory pathFY 2025Topline P3 results; FDA engagement planned FDA Type C meeting provided actionable NDA pathway guidance Clarified pathway

Earnings Call Themes & Trends

(Company did not furnish an earnings call transcript for Q4; themes tracked using successive earnings and corporate press releases.)

TopicPrevious Mentions (Q-2: Q3 FY24 press release; Q-1: Q2 FY24 press release)Current Period (Q4 FY24 press release)Trend
Regulatory – LYMPHIRBLA accepted; PDUFA 8/13/24; pre-launch prep FDA approval achieved; H1’25 launch targeted Positive progression
Mino-Lok Phase 3Topline results anticipated; endpoints later met FDA Type C meeting with clear NDA guidance Advancing toward submission
Halo-LidoEnd-of-Phase 2 FDA engagement planned Continuing FDA engagement; next steps clarified Steady regulatory work
Capital/Runway$15M offering; runway extended to Dec’24 Liquidity tightened; intends to raise capital Deteriorated liquidity
Corporate structureOncology spin-off progressing CTOR listed; shareholder distribution eyed 2025 Execution milestone
Listing complianceN/A1-for-25 reverse split to regain compliance Addressed

Management Commentary

  • “It was a transformative year, marked by our first FDA approval and significant clinical milestones… exploring strategic partnerships and licensing opportunities to maximize the potential of our portfolio” — Leonard Mazur, Chairman and CEO .
  • “Looking ahead… launching LYMPHIR… driving the clinical and regulatory strategies for Mino-Lok and Halo-Lido, fortifying our financial position… We expect to launch LYMPHIR in the first half of 2025 and distribute CTOR shares… by the end of the year” — Mazur .
  • “The completion of our Phase 3 Pivotal Trial for Mino-Lok… highly statistically significant topline results… secured $15 million in additional funding to extend our runway… completed the spin-off” — Mazur (Q3 update) .
  • “The FDA’s comprehensive feedback supports our commitment to advancing [Mino-Lok]… guidance provides a strong framework for completing the remaining steps toward an NDA submission” — Mazur (Type C meeting) .

Q&A Highlights

  • No Q4 earnings call transcript was available in the company document set; analysis relies on the 8-K and associated press releases .

Estimates Context

  • Wall Street consensus estimates (S&P Global/Capital IQ) for Q4 2024 EPS and revenue were unavailable at retrieval due to SPGI request limits; CTXR reported no revenue and did not furnish standalone Q4 EPS, preventing a beat/miss assessment vs consensus. Values would be retrieved from S&P Global if available.*

Key Takeaways for Investors

  • 2025 is an execution year: LYMPHIR commercial launch in H1 with CTOR infrastructure; inventory and license payable entries indicate manufacturing/launch readiness .
  • Regulatory de-risking for Mino-Lok: Phase 3 success plus FDA Type C guidance frames an NDA path—watch for submission timing and label specifics .
  • Liquidity is a near-term overhang: year-end cash $3.25M; stated intent to raise capital—monitor financing terms, dilution risk, and any non-dilutive options .
  • Operating expense mix shifted: G&A and stock-based comp elevated in FY24; management guides R&D lower in FY25 as programs transition—track expense discipline through launch .
  • Corporate actions: reverse split to maintain listing and potential distribution of CTOR shares in 2025—both can influence shareholder value and trading dynamics .
  • Narrative catalysts: launch trajectory, initial LYMPHIR uptake/coverage, Mino-Lok NDA progress, and capital raises are likely primary stock movers in the near term .

*Values retrieved from S&P Global.