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Citius Pharmaceuticals, Inc. (CTXR)·Q2 2025 Earnings Summary

Executive Summary

  • Citius reported no revenue and a wider net loss in Q2 FY25 as it readied LYMPHIR for launch; EPS of -$1.27 missed S&P Global consensus EPS of $0.11, while revenue matched a $0.0 consensus as the company remains pre-revenue . EPS consensus from S&P Global shown with an asterisk; see disclaimer.*
  • Management emphasized imminent commercialization of LYMPHIR (J-code effective April 1, 2025) and continued financing needs; cash was $26,410 at quarter-end, and the company stated it needs additional capital to support operations beyond May 2025 .
  • Strategic actions included amending the Eisai license to align payments with the commercialization timeline and retaining Jefferies to evaluate strategic alternatives for Citius Oncology (CTOR) .
  • Stock reaction: CTXR fell 11.7% the trading day after the Q2 release (5/14/25), reflecting the miss and liquidity concerns .

What Went Well and What Went Wrong

What Went Well

  • LYMPHIR reimbursement readiness advanced: permanent HCPCS J-code (J9161) effective April 1, 2025, which facilitates billing and payer coverage, a key launch enabler .
  • Launch preparations progressed: first-year launch supply produced; healthcare provider education, market access groundwork, and patient support infrastructure underway .
  • Clarified next steps for pipeline: preparing an FDA submission based on feedback for Mino-Lok after Phase 3 met primary endpoints, indicating a pathway toward a future NDA .

What Went Wrong

  • Earnings miss and continued losses: Q2 EPS -$1.27 vs S&P Global consensus $0.11*, driven by higher G&A and R&D and a year-ago benefit from selling New Jersey NOLs; no revenue yet to offset expenses .*
  • Liquidity risk escalated: only $26,410 cash at 3/31/25; management stated additional capital is needed to support operations beyond May 2025, implying urgency and dilution risk .
  • Increased LYMPHIR-related R&D costs (six-month basis) due to drug substance batch for pre-license inspection, contributing to elevated spend ahead of commercialization .

Financial Results

MetricQ2 2024 (YoY)Q1 2025 (QoQ)Q2 2025 (Current)Consensus (Q2 2025)
Revenue ($)$0 $0 $0 $0.0*
Total Operating Expenses ($)$10,970,201 $10,039,614 $11,260,678
Operating Loss ($)$(10,970,201) $(10,039,614) $(11,260,678)
Net Loss ($)$(8,544,154) $(10,281,246) $(11,511,505)
Diluted EPS ($)$(1.34) $(1.30) $(1.27) $0.11*

Notes:

  • No margins are presented as revenue was $0 in all periods.
  • Q2 2024 benefited from $2.39M gain on sale of NJ NOLs, boosting other income YoY .
  • S&P Global estimates marked with asterisk; see disclaimer.*

Operating expense detail and KPIs:

KPI / ExpenseQ2 2024Q1 2025Q2 2025
R&D Expense ($)$3,605,898 $2,127,038 $3,766,525
G&A Expense ($)$4,285,911 $5,387,752 $4,792,122
Stock-based Comp – G&A ($)$3,078,392 $2,524,824 $2,702,031
Cash & Equivalents (end of period, $)$1,100,079 (12/31/24) $26,410 (3/31/25)
Inventory (end of period, $)$14,381,369 $15,339,253
Accounts Payable (end of period, $)$7,364,120 $9,368,234
License Payable (end of period, $)$28,400,000 $28,400,000
Weighted Avg Shares (basic/diluted)6,362,890 7,492,460 8,581,207

Balance sheet snapshot (oldest → newest):

MetricSep 30, 2024Dec 31, 2024Mar 31, 2025
Cash & Equivalents ($)$3,251,880 $1,100,079 $26,410
Inventory ($)$8,268,766 $14,381,369 $15,339,253
Total Current Liabilities ($)$35,814,803 $44,805,958 $49,876,642
Total Equity ($)$74,101,830 $68,919,459 $63,575,792
Common Shares Outstanding (period-end)7,247,243 7,727,243 8,760,649

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
LYMPHIR Launch TimingFY1H25“Launch in the first half of 2025” (FY24 update, Dec-2024) Launch preparations ongoing; J-code effective Apr 1, 2025; first-year supply produced Maintained; execution milestones achieved
R&D Expense TrendFY2025Expect R&D to decrease in FY2025 (Q1 FY25) Expect R&D to continue decreasing in FY2025 as focus shifts to LYMPHIR commercialization Maintained
Liquidity/RunwayNear-termRaise additional capital to support operations (FY24) Needs additional capital to support operations beyond May 2025 Worsened (timing more urgent)
CTOR Strategic Actions2025Distribute CTOR shares by end-2025 subject to conditions (FY24) CTOR retained Jefferies to evaluate strategic alternatives Evolving (strategic review underway)
Mino-Lok Regulatory Path2025Continued FDA engagement post-Phase 3 Preparing FDA submission based on agency feedback to support future NDA Clarified next step

No quantitative revenue, margin, OpEx, or tax rate guidance was provided in Q2 materials .

Earnings Call Themes & Trends

No Q2 FY25 earnings call transcript was found in our document system or via open web search; analysis below leverages company press releases and filings. We searched for “earnings-call-transcript” for CTXR (2025-01-01 to 2025-11-20) and found none; also checked PR Newswire/company IR pages .

TopicPrevious Mentions (Q-2 & Q-1)Current Period (Q2 FY25)Trend
LYMPHIR launch readinessFY24: launch in 1H25; commercial prep ongoing . Q1: progressing toward 1H25 launch .J-code effective 4/1/25; first-year supply produced; HCP education, access, and support in place .Execution progressing; launch infrastructure in place
ReimbursementQ1: CMS permanent J-code secured, effective 4/1/25 .J-code goes live in Q2 period; coding clarity for payers/providers .Positive catalyst realized
Financing/capitalFY24: planned capital raises . Q1: raised $6.5M gross; ongoing needs .April 2025 direct offering (~$1.735M net); company needs capital beyond May 2025 .Urgency increased; dilution risk elevated
CTOR strategic pathFY24: CTOR distribution targeted by YE25, conditions permitting .CTOR retained Jefferies to evaluate strategic alternatives .Strategy under active review
Mino-Lok regulatoryFY24: continued FDA engagement post-Phase 3 .Preparing FDA submission per feedback to support future NDA .More concrete next step
Manufacturing/supply chainFirst-year LYMPHIR launch supply produced; CMOs secured .Launch readiness improved

Management Commentary

  • “We are actively engaged in securing the necessary financing to advance our launch strategy in the coming months, as well as exploring strategic partners for Citius Oncology.” — Leonard Mazur, Chairman & CEO .
  • “We are also in the process of preparing a submission to the FDA… a key step toward supporting a future New Drug Application (NDA) for our Mino-Lok program… our Phase 3 Trial… met its primary endpoints.” — Leonard Mazur .
  • “We… amended our license agreement with Eisai to align our payment obligations with our commercialization timeline.” — Leonard Mazur .
  • On reimbursement: “The establishment of a permanent J-code marks a critical milestone in supporting patient access to LYMPHIR… facilitating reimbursement.” — Leonard Mazur .

Q&A Highlights

  • No Q2 FY25 earnings call transcript was available; the company’s commentary is limited to the press release and filings .
  • As such, there were no published analyst Q&A clarifications on launch pacing, initial LYMPHIR demand, or cash runway beyond the disclosed “beyond May 2025” statement .

Estimates Context

  • EPS: Actual -$1.27 vs S&P Global consensus $0.11*; a significant miss driven by higher operating expenses and lack of one-time other income vs prior year .*
  • Revenue: Actual $0 vs S&P Global consensus $0.0*, consistent with pre-revenue status .*
  • We note other aggregators showed different EPS consensus for Q2 FY25; for consistency, this recap anchors on S&P Global consensus per instruction .*

Actual vs. consensus (current quarter):

MetricActualConsensus
Revenue ($)$0 $0.0*
EPS ($)$(1.27) $0.11*

Key Takeaways for Investors

  • Near-term catalyst is LYMPHIR’s commercial start with reimbursement infrastructure in place (J-code live 4/1/25); inventory build suggests readiness, but timing of initial orders remains the key swing factor for CTXR .
  • Liquidity is the principal risk: $26,410 cash at 3/31/25 and explicit need for additional capital beyond May 2025 point to ongoing dilution or partnering as likely funding paths .
  • Strategic optionality via CTOR: Jefferies-led review could lead to financing, partnerships, or structural changes; outcome may influence capital needs at the parent (CTXR) .
  • Pipeline clarity improved: upcoming FDA submission for Mino-Lok (post-Phase 3 success) offers a second value driver beyond LYMPHIR, though timelines are not guided .
  • Expense profile should moderate in FY25 per management (R&D decline as commercialization focus intensifies), aiding burn once revenue begins, but near-term losses persist absent sales .
  • Stock traded down 11.7% post-print, reflecting the miss vs consensus and runway concerns; upside scenario hinges on clean early launch execution and financing on acceptable terms .
  • Monitor: first commercial LYMPHIR sales, payer uptake, any CTOR strategic outcomes, and details of the Eisai license payment alignment to the launch timeline .


*Values retrieved from S&P Global.