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EP

ELITE PHARMACEUTICALS INC /NV/ (ELTP)·Q1 2026 Earnings Summary

Executive Summary

  • Q1 FY2026 revenue surged 114% year over year to $40.21M on Elite-label growth and the lisdexamfetamine (Vyvanse generic) launch; operating income rose to $21.70M, but GAAP net loss of $5.88M reflected a large non-cash warrant liability revaluation and tax expense .
  • Gross margin expanded to 68% (from 45% YoY) on mix shift to higher-margin products and higher proportion of direct Elite-label sales; operating leverage was significant (operating income +$17.8M YoY) .
  • Cash generation was strong: $14.78M operating cash flow in the quarter; working capital increased to $67.10M as AR and inventory grew with orders; related-party loans were repaid in June, strengthening the balance sheet .
  • No formal quantitative guidance was issued; key stock narrative drivers are sustainability of Vyvanse generic share amid heavy competition/DEA quota dynamics and the non-cash derivative warrant swings that distort GAAP EPS optics .

What Went Well and What Went Wrong

  • What Went Well

    • Triple-digit YoY growth with margin expansion: revenue +114% to $40.21M; gross margin 68% vs 45% prior-year quarter; operating income $21.70M vs $3.86M .
    • Mix improvements and Elite-label strategy: management cited higher shares of higher-margin products and more direct sales as the primary drivers .
    • Execution/cash: $14.78M operating cash flow; working capital rose to $67.10M; repayment of $4.0M related-party loans in June improved leverage optics .
    • “We are doing excellent with Lisdex… more than 10 suppliers… Elite currently has about 8–10% of the market” (CEO, Q4 FY2025 call) .
  • What Went Wrong

    • GAAP noise: $22.11M non-cash expense from change in fair value of warrant derivatives drove a GAAP net loss; CFO emphasized this item never uses/produces cash .
    • Material weaknesses in internal controls (segregation of duties, documentation/testing of controls) remained as of June 30, 2025 .
    • Concentration/legal risk: top 3 customers were 76% of revenue; Purdue litigation over OxyContin ANDA continues (motions filed; outcome uncertain) .

Financial Results

MetricQ1 FY2025Q3 FY2025Q1 FY2026
Revenue ($M)$18.80 $14.36 $40.21
Gross Profit ($M)$8.47 $6.12 $27.23
Gross Margin %45% 43% 68%
Operating Income ($M)$3.86 $1.10 $21.70
Net (Loss)/Income ($M)$0.62 $(10.89) $(5.88)
Diluted EPS ($)$0.00 $(0.01) $(0.01)
Change in FV of Warrants ($M)$(2.78) $(11.73) $(22.11)

Revenue mix

Revenue MixQ1 FY2025Q3 FY2025Q1 FY2026
Manufacturing Fees ($M)$18.44 $13.74 $39.78
Licensing Fees ($M)$0.36 $0.63 $0.43

Segment

SegmentQ1 FY2025Q1 FY2026
ANDA Operating Income ($M)$6.31 $25.55
NDA Revenue$0 (paused) $0 (paused)

KPIs/Balance sheet highlights

  • Operating cash flow: $14.78M (Q1 FY2026)
  • Working capital: $67.10M (6/30/25)
  • Warrant derivative liability: $47.31M (6/30/25)
  • Top-3 customer concentration: 76% of revenue (Q1 FY2026)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY2026/Q2+None providedNone providedN/A
Gross MarginFY2026/Q2+None providedNone providedN/A
OpEx/OtherFY2026/Q2+None providedNone providedN/A
Tax RateFY2026/Q2+None providedNone providedN/A
Dividends/Capital ReturnsFY2026/Q2+None providedNone providedN/A

Management did not issue numeric guidance in the quarter and filings contain no forward quantitative outlook .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 FY2025 and Q4 FY2025)Current Period (Q1 FY2026)Trend
Vyvanse generic (lisdexamfetamine)Launch Dec-2024; highly competitive (13 suppliers), price/DEA quota pressure; Elite ~8–10% share; strong margins (CEO/CFO) Primary driver of Q1 growth, mix lift for gross margin Positive contribution; monitor pricing/quotas
Supply/DEA quotasQuota pressure typical for CII products (CFO) Not specifically updated; still an industry factorNeutral; ongoing operational constraint
Tariffs/APIAPIs exempt; minimal tariff impact (CEO) No updateStable
Legal/regulatory (OxyContin ANDA)Case stayed pending appeals; Fed. Cir. affirmed invalidity in Accord I (Dec-2024); stays updated Jan-2025 Purdue filed amended complaints; motions to dismiss filed Jun–Aug 2025; outcome uncertain Ongoing litigation risk
Capacity/operationsNew packaging site approved (Feb-2025) and two packaging lines running (CEO) Supporting higher volumes; margin benefit from insourcing reflected in Q1 Positive
R&D/pipelinePositive BE for undisclosed anticoagulant; ANDA filing targeted; broader pipeline in development (CEO) Positive BE confirmed (Jun-16-2025); preparing ANDA submission Advancing
InternationalIsrael Adderall IR approval; initial orders via Dexcel No updateEarly-stage

Management Commentary

  • “The increase in operating profits was primarily attributed to sales of Elite’s lisdexamfetamine products… as well as overall strong growth in the Elite label product lines” (Q1 FY2026 press release) .
  • “If our stock price increases, we record an expense [for derivative warrants]… this is a noncash expense… we will never pay cash for any expense shown” (CFO) .
  • “Elite currently has about 8–10% of the [Vyvanse generic] market… 13 companies… margins continue to be very attractive” (CEO) .
  • Q1 gross margin expansion “primarily due to [a] greater proportion of higher margin products [and] greater proportion of direct sales” (MD&A) .

Q&A Highlights

  • Capital markets/M&A: Priority on M&A first; potential Nasdaq uplisting considered only if M&A not attractive; valuation work underway with external firm (CEO) .
  • DEA quota/API: Quota remains a constraint typical of CII markets; APIs used by Elite currently tariff-exempt with minimal duty impact (CEO/CFO) .
  • Capacity: Two packaging lines operational at new facility; previous line moved after new line stabilized (CEO) .
  • Pipeline: Positive BE for a large anticoagulant brand (no US generic); ANDA preparation ongoing; additional ANDAs under review (CEO) .
  • Financial optics: CFO reiterated warrant-derivative mechanics and non-cash nature of related P&L swings .

Note: A Q1 FY2026 earnings call was scheduled, but a full transcript was not available in our document set; Q&A themes reflect the most recent (Q4 FY2025) call .

Estimates Context

  • Wall Street consensus (S&P Global/Capital IQ): No published EPS or revenue consensus for ELTP’s Q1 FY2026 was available; coverage appears limited for this microcap. Actual revenue was $40.21M (per 10-Q) .
  • Implication: With no consensus anchor, post-print estimate revisions are unlikely; investor focus should remain on volume/mix sustainability and margin durability rather than a “beat/miss” frame.

(Values related to consensus retrieved from S&P Global; none available for this period.)

Key Takeaways for Investors

  • Core run-rate reset higher: Q1 revenue of $40.21M with 68% gross margin indicates meaningful scale/mix improvement; monitor whether this level is sustainable through competitive cycles in ADHD generics .
  • GAAP optics vs cash reality: Non-cash warrant valuation drove GAAP loss; cash flow from operations was $14.78M, and working capital expanded materially to support growth .
  • Competitive dynamics: CEO flagged 13 competitors and quota pressure in Vyvanse generics; watch pricing and DEA allocation updates—key swing variables for revenue/margins .
  • Balance sheet de-risking: Related-party loans were repaid in June; low traditional debt, improving financial flexibility .
  • Governance/process: Material weaknesses in internal controls persist; remediation progress will matter for uplisting/M&A credibility .
  • Legal overhang: Purdue litigation around OxyContin ANDA continues; outcomes/timeline remain uncertain and could influence optionality in pain portfolio .
  • Pipeline optionality: Positive BE on a large anticoagulant (no current generic) provides medium-term upside if ANDA approval and patent hurdles are navigated .

Appendix: Prior Quarters Reference

  • Q3 FY2025 revenue $14.36M; softness tied to holiday shipment timing; subsequent packaging site approval supported further scale .
  • FY2025 revenue $84.0M (+~48% YoY) with operating income $19.6M (+~81% YoY), establishing momentum into FY2026 .