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EP

ELITE PHARMACEUTICALS INC /NV/ (ELTP)·Q2 2026 Earnings Summary

Executive Summary

  • Q2 FY2026 revenue was $36.3M, up 92% year over year, driven primarily by lisdexamfetamine (generic Vyvanse) and continued growth of Elite-label amphetamine products .
  • Operating income rose 136% YoY to $8.2M, but margins compressed sequentially versus Q1 due to competitive price pressure and one-time wholesaler stocking fees on lisdexamfetamine; volumes increased but ASPs fell as DEA quota expanded industry supply .
  • Six-month revenue reached $76.5M, nearly matching all of FY2025’s $84M, with working capital strengthening to $75M and low, declining debt—key balance sheet positives .
  • No formal quantitative guidance was issued; management expects pricing to stabilize next quarter and continued brand-to-generic conversion tailwinds for lisdexamfetamine and steady share in amphetamine IR/ER .
  • Potential catalysts: M&A exploration (site visits by suitors), pipeline progress (Oxycodone ER Paragraph IV, undisclosed anticoagulant ANDA in Q1/Q2 CY2026), and international expansion via Dexcel in Israel .

What Went Well and What Went Wrong

What Went Well

  • Lisdexamfetamine commercial ramp: “We have maintained an 8% market share according to our internal data…lisdex volume grew 6% this quarter compared to last quarter according to IQVIA” .
  • Elite-label momentum: IR amphetamine market share ~19% and total amphetamine ~12%, with attractive margins and reliable supply positioning .
  • Balance sheet strength: “Working capital…was $75M…current assets increased from $58M to $86M while current liabilities decreased from $11.8M to $10.7M…Elite has low debt” .

What Went Wrong

  • Margin compression QoQ: Expanded DEA quota increased market supply for Vyvanse generics, pressuring price—plus one-time wholesaler stocking fees elevated COGS in the quarter .
  • Higher G&A: Scaling sales administration and compliance across 50 states and Puerto Rico drove G&A to $4.0M vs. $2.3M YoY and $3.4M in Q1 .
  • Inventory timing noise: Inventory declined $1.2M QoQ due to quarter-end shipment timing and raw materials in transit; not a demand signal .

Financial Results

Results vs Prior Periods (USD)

MetricQ3 2025 (oldest)Q1 2026Q2 2026 (newest)
Revenue ($M)$14.36 $40.21 $36.32
Gross Profit ($M)$6.12*$27.23*$14.07*
Gross Margin (%)42.6%*67.7%*38.7%*
Operating Income ($M)$1.10*$21.70 $8.20
EBIT Margin (%)7.6%*54.0%*22.6%*
Net Income ($M)$(10.89)*$(5.88)*$13.70*
Diluted EPS (Continuing Ops)$(0.010)*$(0.010)*$0.01*
EBITDA ($M)$1.53*$22.09*$8.61*
EBITDA Margin (%)10.7%*54.9%*23.7%*

Notes:

  • Revenue and operating income align with company disclosures; Q2 press release cites $36.3M revenue and $8.2M operating income ; Q1 press release cites $40.2M revenue and $21.7M operating income ; Q3 revenue per 8-K was $14.4M .
  • Values marked with * retrieved from S&P Global.

Year-over-Year Comparison (USD)

MetricQ2 2025Q2 2026
Revenue ($M)$18.88*$36.32
Gross Profit ($M)$8.20*$14.07*
Operating Income ($M)$3.48*$8.20
Net Income ($M)$(11.04)*$13.70*
Diluted EPS (Continuing Ops)$(0.0103)*$0.01*
EBITDA ($M)$3.91*$8.61*

Notes:

  • Q2 2026 growth primarily reflects lisdexamfetamine launch and Elite-label strength .
  • Values marked with * retrieved from S&P Global.

KPIs and Balance Sheet Highlights

KPIQ3 2025Q1 2026Q2 2026
Working Capital ($M)$33.36*$67.10*$75.12
Operating Cash Flow ($M, YTD)—$14.78*$19.90 (six months)
Lisdexamfetamine Market Share——~8% (internal), +6% QoQ volume (IQVIA)
Amphetamine IR Market Share~17–20%~20%~19%
Amphetamine Total Share——~12%

Notes:

  • Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueNext QuarterNoneNone (no formal quantitative guidance)Maintained (no guidance)
Pricing/MarginsNext Quarter—Pricing expected steady; margins stabilizing with normalization after stocking fees Directional steady
OpEx (G&A)FY2026—Elevated due to scale and compliance; no numeric guide Informational
Cash/Working CapitalFY2026—Working capital increasing; low/decreasing debt Positive trajectory

No formal numerical guidance ranges were provided this quarter .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2025, Q4 2025)Current Period (Q2 2026)Trend
DEA Quota & SupplyQuota tightness managed; impact on launch pacing DEA relaxed quotas broadly; increased supply pressured prices More supply → price pressure
Pricing & MarginsAnticipated margin compression as generics scale Lower ASPs on lisdex; one-time stocking fees depressed margins Near-term compression; stabilization expected
Lisdexamfetamine RampJanuary launch; strong volumes; share 8–10% early ~8% share; +6% QoQ volume; continued conversion Sustained ramp
Amphetamine IR/ER ShareIR ~17–20%; ER ~13–16% (incl. Prasco) IR ~19%; total amphetamine ~12% Stable/high share
Compliance/State FilingsFacility approvals; packaging expansion G&A up on compliance across 50 states + PR Higher fixed costs
Pipeline (Oxy ER, Anticoagulant)Oxy ER Paragraph IV; anticoagulant BE success; ANDA planned Oxy ER litigation stayed; anticoagulant ANDA in Q1/Q2 CY2026 Advancing filings
M&A/UplistingExploring M&A first, then possible uplisting Site visits; several interested parties; M&A primary focus M&A momentum

Management Commentary

  • “We have maintained an 8% market share [for lisdexamfetamine]…lisdex volume grew 6% this quarter compared to last quarter according to IQVIA…pricing for the next quarter should be steady” — Nasrat Hakim, CEO .
  • “There are more than 10 suppliers…increase in quota…we increased our volumes, but we sold at lower prices…one-time stocking fees…resulted in higher COGS and lower margins” — Carter Ward, CFO .
  • “Working capital…$75M…current assets increased…current liabilities decreased…Elite has low debt” — Carter Ward, CFO .
  • “Our primary focus is M&A…several showed interest…at least one [visitor] this year” — Nasrat Hakim, CEO .

Q&A Highlights

  • Margins and pricing: Management highlighted competitive pricing pressure from expanded quota and >10 Vyvanse generic suppliers; stocking fees are one-time and behind them .
  • G&A drivers: Growth in sales administration and compliance across 50 states plus Puerto Rico increased G&A to $4.0M for the quarter .
  • Pipeline timing: Oxycodone ER Paragraph IV litigation remains stayed; undisclosed anticoagulant ANDA targeted for Q1/Q2 CY2026 filing .
  • Product strategy: Focus remains on higher-margin CNS products (lisdexamfetamine, amphetamine IR/ER); lower-margin opioids remain secondary until capacity increases .
  • M&A: Several suitors have engaged with site visits; valuation work underway; uplisting remains a secondary path if M&A does not materialize .

Estimates Context

  • S&P Global consensus estimates were not available for ELTP this quarter (no published “Primary EPS Consensus Mean” or “Revenue Consensus Mean”/# of estimates), so results could not be benchmarked to Street expectations [GetEstimates].
  • Given missing coverage, any post-report estimate revisions are unlikely to be a near-term catalyst; focus shifts to narrative (pricing stabilization, quota/supply normalization) and M&A optionality .

Key Takeaways for Investors

  • YoY growth remains strong (+92% revenue, +136% operating income), but sequential margin compression reflects early-stage generic dynamics and one-time stocking costs; watch for stabilization next quarter .
  • Balance sheet strength (rising working capital, low/decreasing debt) provides flexibility to navigate competitive pricing and fund pipeline/working capital .
  • Strategic focus on higher-margin CNS portfolio with established shares (IR ~19%, amphetamine ~12%) supports resilience despite broader price competition .
  • Pipeline and legal milestones (Oxy ER litigation developments; anticoagulant ANDA filing in Q1/Q2 CY2026) are potential medium-term catalysts .
  • M&A interest and site visits introduce optionality; outcomes could drive valuation re-rating independent of quarterly noise .
  • Near-term trading: Expect sensitivity to commentary around pricing stabilization and quota/supply; absence of Street estimates means narrative/operational updates may dominate stock reaction .
  • Medium-term thesis: Continued brand-to-generic conversion, Elite-label penetration, and disciplined product prioritization support earnings durability, with upside from pipeline launches and corporate actions .

References:

  • Q2 FY2026 8-K press release with financials and call info .
  • Q2 FY2026 earnings call transcript (financials, market shares, margins, pipeline, M&A) .
  • Prior quarter Q1 FY2026 press release ; Q3 FY2025 press release ; Q4 FY2025 call (historical context) .

Footnote: Values marked with * in tables were retrieved from S&P Global.