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CP

CUMBERLAND PHARMACEUTICALS INC (CPIX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $10.44M, up 11.6% year over year; full-year 2024 revenue was $38.0M, with Q4 product mix led by Kristalose ($4.4M), Sancuso ($2.4M), Vibativ ($2.1M), and Caldolor ($1.4M) .
  • GAAP net loss in Q4 was $(1.90)M or $(0.14) per share vs $(6.29)M or $(0.44) in Q4 2023; adjusted diluted loss per share improved to $(0.02) vs $(0.11) in Q4 2023, reflecting lower operating expenses and amortization/impairment vs prior year .
  • Management guided to double‑digit revenue growth and positive cash flow from operations in 2025; no numerical ranges were provided .
  • Potential catalysts: positive Phase 2 DMD cardiomyopathy results for ifetroban and Vibativ approval in China (with Saudi shipments begun), enhancing pipeline credibility and international growth optionality .

What Went Well and What Went Wrong

  • What Went Well

    • Revenue grew 11.6% YoY in Q4; mix showed healthy contributions from Kristalose ($4.4M) and Sancuso ($2.4M) .
    • New regulatory and geographic milestones: FDA approved an Acetadote sNDA simplifying dosing; Vibativ received China approval and began shipments to Saudi Arabia .
    • Pipeline momentum: “first successful Phase II study specifically targeting the cardiac complications” in DMD (ifetroban) with LVEF improvement signal; CEO: “We expect to deliver double digit revenue growth this year as well as positive cash flow from operations” .

  • What Went Wrong

    • Company remained loss‑making in Q4 (GAAP net loss $(1.90)M; $(0.14) per share), despite YoY improvement; operating loss was $(1.84)M .
    • Sequential operating expenses increased vs Q3 ($12.28M in Q4 vs $10.78M in Q3), partly reflecting amortization timing; interest expense rose YoY ($223k vs $179k) .
    • Guidance remained qualitative (no revenue/EPS ranges); external reimbursement tailwind for Caldolor remains uncertain after earlier CMS developments (NOPAIN) discussed in 2H 2024 updates .

Financial Results

Overall results vs prior quarters (oldest → newest):

MetricQ2 2024Q3 2024Q4 2024
Net Revenues ($)$9,848,849 $9,085,826 $10,435,569
Operating Loss ($)$(1,026,688) $(1,694,432) $(1,842,039)
Total Operating Expenses ($)$10,875,537 $10,780,258 $12,277,608
Net Loss Attributable to Common ($)$(1,085,612) $(1,544,081) $(1,903,814)
Basic EPS ($)$(0.08) $(0.11) $(0.14)
Adjusted Diluted EPS ($)$0.01 $(0.02) $(0.02)

Q4 year-over-year comparison:

MetricQ4 2023Q4 2024
Net Revenues ($)$9,353,066 $10,435,569
Total Operating Expenses ($)$15,532,305 $12,277,608
Operating Loss ($)$(6,179,239) $(1,842,039)
Net Loss Attributable to Common ($)$(6,291,020) $(1,903,814)
Basic EPS ($)$(0.44) $(0.14)
Adjusted Diluted EPS ($)$(0.11) $(0.02)

Segment/product revenue (Q3 vs Q4):

Product Revenue ($)Q3 2024Q4 2024
Kristalose$3.6M $4.4M
Sancuso$2.6M $2.4M
Vibativ$1.0M $2.1M
Caldolor$1.3M $1.4M

KPIs and balance sheet:

KPI9/30/202412/31/2024
Cash & Cash Equivalents ($)$17,464,754 $17,964,184
Total Assets ($)$76,747,513 $75,583,410
Total Liabilities ($)$52,278,121 $53,037,433
Shareholders’ Equity ($)$24,779,086 $22,853,494
Credit Facility Outstanding ($)$16.1M $15.3M
Gross Margin % (reported)85% (Q3) —

Notes:

  • Q4 2024 revenue +11.6% YoY per release; operating expenses and losses improved materially YoY .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue GrowthFY 2025None disclosed“Double‑digit revenue growth” New
Cash From OperationsFY 2025None disclosed“Positive cash flow from operations” New
Product/SegmentFY 2025—No quantitative segment guidance providedMaintained lack of quant detail

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4)Trend
Supply chain/weather impactsQ3: Hurricane Helene caused shipment delays/returns; IV fluid shortages constrained Vibativ usage .Not highlighted in Q4; product volumes recovered (Vibativ $2.1M) .Improving normalization.
International expansionVibativ Saudi approval/launch prep; China approval effort; South Korea updates .Vibativ received China approval; shipping began to Saudi Arabia .Positive acceleration.
Regulatory/labelingExpect NOPAIN implementation; submitted for reimbursement considerations (Caldolor) .FDA approved Acetadote sNDA simplifying dosing .Mixed: Acetadote positive; NOPAIN outcomes uncertain (earlier CMS stance) .
Pipeline (ifetroban)Applied for Orphan & Rare Pediatric Disease designations; multiple Phase II programs; enrollment progress .DMD Phase II showed LVEF improvement signal; Orphan/RPD designations confirmed .Strengthening efficacy/timeline narrative.
Product performanceQ2: revenue +16% seq; Q3: revenue $9.1M; gross margin 85%; Sancuso expansion; Kristalose Medicaid coverage grew .Q4: revenue $10.44M; Kristalose $4.4M lead; Sancuso $2.4M; Vibativ $2.1M; Caldolor $1.4M .Sequential rebound, mix stabilizing.
Financial postureCash ~$17–18M; credit facility ~$16M; share repurchases .Cash $18M; credit facility ~$15.3M; equity $23M .Stable liquidity, modest deleveraging.

Management Commentary

  • “Our portfolio of FDA approved brands delivered strong net revenues of $10,400,000 which represented an 11.6 percent increase over the prior year period.” — A.J. Kazimi, CEO .
  • “We expect to deliver double digit revenue growth this year as well as positive cash flow from operations.” — A.J. Kazimi, CEO .
  • On DMD Phase 2: “This marks a breakthrough… the first successful Phase II study that specifically targeted the cardiac complications of their condition… high dose ifetroban provided a significant improvement in LVEF vs controls.” — A.J. Kazimi .
  • On commercial execution: “We now have a total of 50 individuals across the country interacting with the medical community… supporting our FDA approved medicines.” — Todd Anthony .
  • On international Vibativ: “Vibativ received approval by the regulatory authorities in China… [and] began shipping to Saudi Arabia…” — Company press release .

Q&A Highlights

  • There was no Q&A session; the operator concluded the call without questions, with management offering to schedule private follow‑ups .
  • No incremental guidance clarifications beyond qualitative 2025 targets .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 revenue/EPS was unavailable via our S&P Global tool at the time of analysis; thus, we cannot provide a vs‑consensus comparison. Comparisons are made vs prior year/quarter based on company‑reported results .

Key Takeaways for Investors

  • Q4 marked clean YoY growth (+11.6%) and materially narrower losses vs Q4 2023; product mix indicates resilient demand in Kristalose and recovering Vibativ volumes .
  • International and regulatory catalysts (Vibativ China approval; Saudi shipments; Acetadote sNDA) support incremental revenue opportunities and operational efficiency narratives in 2025 .
  • Ifetroban’s DMD Phase 2 signal and Orphan/RPD designations elevate optionality around a transformative asset; next steps include full data analysis and FDA interactions .
  • Liquidity remains solid (cash ~$18M), with modest reduction in credit facility balance; capacity exists to support growth initiatives .
  • Guidance is directional (double‑digit revenue growth, positive operating cash flow) without numeric ranges; watch for 2025 cadence updates and any reimbursement developments for Caldolor .
  • Near‑term watch items: execution on Sancuso oncology expansion, Vibativ international ramp, and timing for DMD program regulatory discussions .

Appendix: Additional Tables

Full‑year 2024 snapshot (GAAP):

MetricFY 2024
Net Revenues ($)$37,867,945
Total Operating Expenses ($)$44,300,354
Net Loss Attributable to Common ($)$(6,479,770)
Adjusted Earnings (Loss) ($)$(990,865)
Cash & Cash Equivalents (12/31/24) ($)$17,964,184
Total Assets (12/31/24) ($)$75,583,410
Total Liabilities (12/31/24) ($)$53,037,433
Shareholders’ Equity (12/31/24) ($)$22,853,494

Selected Q4 2024 income statement line items:

Line Item (Q4)Q4 2023Q4 2024
Net Revenues ($)$9,353,066 $10,435,569
Cost of Products Sold ($)$1,529,983 $1,976,473
Selling & Marketing ($)$4,759,230 $4,222,554
R&D ($)$1,264,753 $1,292,671
G&A ($)$3,439,184 $3,326,466
Amortization & Impairment ($)$4,539,155 $1,459,444
Operating Loss ($)$(6,179,239) $(1,842,039)
Interest Expense ($)$(178,792) $(223,261)
Net Loss to Common ($)$(6,291,020) $(1,903,814)

Additional context and developments:

  • FDA Orphan Drug and Rare Pediatric Disease designations for ifetroban in DMD (Nov 6, 2024) .
  • Real‑world outcomes study: Caldolor vs ketorolac favored Caldolor on ADRs and healthcare utilization (Nov 5, 2024) .
  • FDA approved simplified dosing regimen for Acetadote (Dec 9, 2024) .