Shares of Elite Pharmaceuticals, Inc. ELTP have lost 15.7% since the company reported its earnings for the fiscal year ended March 31, 2025. This compares to the S&P 500 Index’s 0.9% gain over the same time frame. Over the past month, however, the stock rebounded with an increase of 7.2%, outperforming the S&P 500’s 4.4% rise.
ELTP’s Revenue and Profit Surge in Fiscal 2025
Elite Pharmaceuticals posted a significant jump in revenues and operating income for the fiscal year ended March 31, 2025. Total revenues climbed to $84 million, a 48.4% increase from $56.6 million in the previous year. This surge was largely fueled by the strong market performance of its existing Elite label generics and the launch of its lisdexamfetamine product line — an authorized generic for Vyvanse — during the final quarter of the fiscal year.
Operating income also witnessed a steep rise, reaching $19.6 million, up 81.7% from $10.8 million in the prior year. Despite reporting a pretax loss of $52,140 due to a non-cash expense related to a derivative liability adjustment, the company’s underlying operational performance remained robust. Elite Pharmaceuticals recorded breakeven earnings per share (EPS) for fiscal 2025, compared with $0.02 in fiscal 2024. The decline was driven by an $18.9 million non-cash expense linked to the fair value adjustment of warrants, triggered by a tripling in ELTP’s stock price during the year. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
Elite Pharmaceuticals’ Strong Commercial Momentum
Elite Pharmaceuticals entered the competitive lisdexamfetamine (Vyvanse generic) market in early 2025 and quickly captured an estimated 8–10% market share despite competing with more than a dozen suppliers. While pricing pressures persist, management noted that the product’s contribution has been substantial and margin-accretive. The Attention Deficit Hyperactivity Disorder treatment category remains large and growing, particularly as branded prescriptions continue transitioning to generics.
Elite Pharmaceuticals’ existing amphetamine-based generics also continued to generate solid returns. The company holds about 20% market share in mixed amphetamine immediate-release (IR) tablets, a $400 million market. For extended-release amphetamine capsules, it commands a 16% share — 11% under the Elite label and 5% through Burel Pharma (Prasco). Notably, Prasco’s non-exclusive license expired in March 2025, positioning ELTP to market this product exclusively going forward.
Legacy products such as Isradipine and Trimipramine continue to yield favorable margins despite modest market sizes. Elite Pharmaceuticals holds around 50% market share in both. Additionally, generic naltrexone and phentermine products currently under a licensing arrangement with Precision Dose are expected to transition fully to ELTP’s label in September 2025.
Elite Pharmaceuticals Inc. Price, Consensus and EPS Surprise
Elite Pharmaceuticals Inc. price-consensus-eps-surprise-chart | Elite Pharmaceuticals Inc. Quote
ELTP’s Business Drivers and Commentary
Elite Pharmaceuticals reported operating cash flow of $7.5 million in fiscal 2025 against the $3.2 million operating cash usage in the prior year. This improvement stemmed from operational profitability and a more modest increase in working capital compared to the previous year. Working capital rose to $45.9 million as of March 31, 2025 (from $27 million as of March 31, 2024), while current liabilities declined to $11.8 million as of March 31, 2025, from $13 million as of March 31, 2024. Importantly, loans from key executives, including CEO Nasrat Hakim, were fully repaid after the fiscal year-end, reflecting a reduction in debt burden.
Elite Pharmaceuticals’ Management’s Outlook and Tone
CEO Nasrat Hakim highlighted the company’s consistent growth trajectory, noting a compound increase in revenue and operating income since 2021. Hakim attributed ELTP’s success to the strategic expansion of the Elite label, the judicious use of capital and the operational readiness of its packaging infrastructure to support continued scale.
Elite Pharmaceuticals is also weighing strategic options, including mergers, acquisitions, and a potential uplisting to NASDAQ, though no specific actions have been announced.
ELTP’s Pipeline and Forward Strategy
Elite Pharmaceuticals did not provide formal forward-looking revenue or EPS guidance. However, management expressed confidence in sustained growth from its Lisdexamfetamine and amphetamine franchises, coupled with incremental gains from new launches such as methadone and pain-relief generics (Oxy/APAP and Hydro/APAP).
Elite Pharmaceuticals maintains a measured approach to research and development investment. It has two ANDAs under FDA review, including a Paragraph IV filing for generic OxyContin and a dopamine agonist for Parkinson’s disease. A motion to dismiss a patent suit related to Purdue’s OxyContin has been filed, although management anticipates eventual legal proceedings.
A particularly noteworthy development is the successful bioequivalence (BE) study for an undisclosed anticoagulant product, which has reported brand sales of $27 billion. The ANDA filing is expected in the first quarter of fiscal 2026. Several other products are in the formulation and stability testing phase ahead of BE studies.
Factors Influencing Elite Pharmaceuticals’ Financial Outcomes
The sharp increase in operating income and revenue was powered by internal label expansion and successful product launches. However, external factors such as quota constraints on controlled substances and intense price competition in the generic space tempered the outlook. The Lisdexamfetamine market, though lucrative, is under pressure from numerous suppliers, making price erosion a notable risk going forward.
Additionally, the non-cash accounting charge related to derivative valuation distorted net profitability, although it had no impact on cash or operational strength.
ELTP’s Other Developments
During the year, Elite Pharmaceuticals acquired several new products ANDAs via an asset purchase agreement with Nostrum Laboratories. These include generic APAP/Codeine, APAP/Hydrocodone, and Oxy/APAP products. Among them, the Oxy/APAP (generic for Percocet) was launched in April 2025. While ELTP is still building market share in these large but low-margin segments, management has indicated that resources are being prioritized toward higher-margin opportunities, such as Lisdexamfetamine and amphetamines.
Furthermore, Elite Pharmaceuticals’ Israeli partner Dexcel has initiated commercialization preparations for Amphetamine IR tablets, having received regulatory approval in Israel. A second order has already been placed, and ELTP will manufacture the product under a three-year renewable agreement.
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Elite Pharmaceuticals Inc. (ELTP): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).