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Assertio Holdings, Inc. (ASRT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 total revenues were $26.49M and net product sales were $26.00M, tracking the company’s full-year outlook but down year-over-year on Indocin generic pressure and Rolvedon pricing; GAAP loss per share was $(0.14), Adjusted EPS $(0.04) .
  • Versus S&P Global consensus, revenue of $26.49M missed the $27.52M estimate, while Primary EPS of $(0.04) beat the $(0.06) estimate; 5 estimates for both metrics. Values retrieved from S&P Global.*
  • Guidance was maintained: FY 2025 net product sales $108–$123M and Adjusted EBITDA $10–$19M; management expects Rolvedon sales to increase through the year as payer coverage expands and Q4 stocking normalizes .
  • Strategic execution highlights: legal exposure reduced via settlements and subsidiary transfer; focus sharpened on growth assets Rolvedon and Sympazan; potential strategic transaction targeted for 2025 (not included in guidance) .

What Went Well and What Went Wrong

What Went Well

  • Rolvedon demand remains strong with expanding payer coverage (e.g., Cigna) and expected net sales growth through 2025; stocking dynamics from Q4 supported customer expansion in Q1 .
  • Gross margin improved to 70% (reported) from 65% YoY, driven by lower inventory write-downs and completion of Rolvedon inventory step-up amortization .
  • Sympazan revised promotion is working: total prescriptions up 6.5% YoY; Q1 Sympazan sales $2.2M vs $2.6M prior year, with in-person promotion showing responsiveness .
    • “Our revised Sympazan promotional strategy is proving effective, with total Sympazan prescriptions up 6.5% year-over-year in the first quarter.” — CEO Brendan O’Grady .

What Went Wrong

  • Total revenues declined YoY to $26.49M (from $32.45M) and Adjusted EBITDA fell to $0.16M (from $7.38M), reflecting Indocin generic erosion and Rolvedon pricing headwinds .
  • Rolvedon net product sales of $13.1M decreased from $14.5M YoY due to lower pricing, partly offset by higher volume; management cited competitive ASP pressure in the long-acting G-CSF market .
  • SG&A rose to $22.0M from $18.5M YoY, driven by net higher legal charges and settlements ($2.8M shareholder matter); base adjusted OpEx was $18.5M with expected legal burden to decline over time .

Financial Results

MetricQ1 2024Q4 2024Q1 2025
Total Revenues ($USD Millions)$32.45 $32.18 $26.49
Net Product Sales ($USD Millions)$31.86 $29.59 $25.99
Gross Margin % (reported)65% 61% 70%
GAAP EPS ($)$(0.05) $(0.11) $(0.14)
Adjusted EPS ($)$0.04 $(0.03) $(0.04)
Adjusted EBITDA ($USD Millions)$7.38 $(0.53) $0.16
SG&A ($USD Millions)$18.52 $21.42 $21.98

Segment Net Product Sales

Segment ($USD Millions)Q1 2024Q4 2024Q1 2025
Rolvedon$14.5 $15.4 $13.1
Indocin$8.7 $5.5 $5.5
Sympazan$2.6 —$2.2

KPIs and Balance Sheet Highlights

KPIQ1 2024Q4 2024Q1 2025
Cash, Cash Equivalents & Short-Term Investments ($USD Millions)—$100.1 $87.3
Cash from Operations ($USD Millions)$7.51 $11.50 $(12.54)
Debt ($USD Millions)—$40.0 $40.0

Estimate Comparison (S&P Global)

MetricQ1 2025 ConsensusQ1 2025 ActualSurprise
Total Revenue ($USD)$27,519,600*$26,488,000 Miss (~$1.03M)*
Primary EPS ($)$(0.06)*$(0.04) Beat (2c)*
EPS Normalized ($)$(0.01)*$(0.04) Miss (3c)*
Primary EPS - # of Estimates5*——
Revenue - # of Estimates5*——

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Product Sales (GAAP)FY 2025$108.0M–$123.0M Maintained Maintained
Adjusted EBITDA (Non-GAAP)FY 2025$10.0M–$19.0M Maintained Maintained

Management commentary: guidance ranges maintained with intent to reassess in August if needed .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3/Q4 2024)Current Period (Q1 2025)Trend
Rolvedon demand, ASP, payer coverageQ4: Rolvedon $15.4M; stocking in Q4 to pull through Q1; published ASP up ~2% sequentially; competitive pricing dynamics Demand strong; payer coverage expanding (e.g., Cigna); net sales expected to increase through year; ASP managing erosion Gradual improvement; volume growth offsets pricing headwinds
Same-day dosing trial/NCCNQ4: Trial completed; presented Dec and Mar; commercial impact not yet visible Manuscript targeted mid-summer; approach NCCN for 2026 inclusion; awareness-building continues Building awareness; potential guideline catalyst in 2026
Indocin genericizationQ4: Two generics + compounder in market; expecting 1–2 more in 2025 Plan assumed two more generics in 2025; decline with each entrant; tracking to plan Continued decline; managed optimization
Sympazan promotionQ4: Pilot showed promotional sensitivity; added small field team Prescriptions +6.5% YoY; $2.2M Q1 sales; considering optimal field FTE and options Positive momentum
Legal exposure/OpExQ4: Focus to reduce exposure; contingency in Q4 not opioid-related Multiple settlements; subsidiary transfer removes opioid litigation from current entities; base adjusted OpEx $18.5M; legacy legal burden expected to decline $2–$3M annually Improving; OpEx tailwind over time
Macro/tariffs/drug pricing—Tariff exposure limited near term due to U.S. inventory; minimal current risk from drug pricing changes; monitor developments Neutral near term

Management Commentary

  • “Net sales came in slightly ahead of plan at $26 million, and we are tracking to our full year net product sales and adjusted EBITDA outlook.” — CEO Brendan O’Grady .
  • “We have settled multiple prior legal matters… and obtained a dismissal of the Company’s Edwards securities class action… As a result… neither Assertio Holdings nor any of its current subsidiaries are defendants in any opioid-related litigation.” .
  • “Our strategy includes… reduce legal exposure; simplify our corporate structure… prioritize investment in growth assets; divest non-core assets; and use the strength of our balance sheet to close a strategic transaction.” .
  • “Cash flow from operations during the first quarter was impacted by the timing of approximately $12 million of accounts receivable collected in early April.” — CFO Ajay Patel .

Q&A Highlights

  • Legal/OpEx: Base adjusted OpEx ~$18.5M; legacy legal mitigation expected to benefit $2–$3M annually; shareholder litigation burden declines over time .
  • Rolvedon growth levers: Expand payer coverage (Cigna live; more in H2 2025), further share gains in Medicare Part B clinics, hospital penetration contingent on commercial coverage .
  • Indocin generics: Expect ~two additional entrants in 2025; each entrant pressures volume and price; optimization ongoing .
  • Guidance: No change to ranges; revisit in August if warranted .
  • Same-day dosing/NCCN: Manuscript targeted for mid-summer; plan to approach NCCN for 2026 guidelines inclusion; commercial impact to build gradually .

Estimates Context

  • Q1 2025 revenue missed consensus ($26.49M vs $27.52M), while Primary EPS beat ($(0.04) vs $(0.06)); Normalized EPS missed ($(0.04) vs $(0.01)). Values retrieved from S&P Global.*
  • Expect Street to focus on: Rolvedon trajectory into Q2/Q3 as stocking normalizes and payer coverage expands; gross margin sustainability at ~70% given volume mix; SG&A/legal trendline; and any color on BD timing in 2025 .

Key Takeaways for Investors

  • Rolvedon pacing: Watch Q2/Q3 net sales for sequential growth as Q4 stocking pull-through normalizes and payer coverage expands; management expects increases through 2025 .
  • Margin dynamics: Reported gross margin reached 70% on lower write-downs and step-up amortization completion; monitor mix impact from higher Rolvedon volumes .
  • Legal tailwinds: Settlements and structural transfer remove opioid litigation from current entities; expect $2–$3M annual OpEx benefit from legacy legal reduction over time .
  • Indocin headwinds: Continued genericization likely to pressure revenue and price; plan assumes more entrants; treat any slower-than-expected erosion as upside .
  • Liquidity and cash timing: Cash & investments $87.3M at quarter-end, ~$(12.5)M operating cash flow driven by AR timing; ~$12M collected in April — follow working capital normalization .
  • Guidance unchanged: FY 2025 net product sales $108–$123M and Adjusted EBITDA $10–$19M; update possible in August .
  • Potential BD catalyst: Numerous ongoing conversations; management optimistic about closing a strategic transaction in 2025; current guidance excludes any deal .