Elite Pharmaceuticals, Inc. filed an 8-K to announce timing for its fiscal year 2026 results and a related conference call. The company will release financial results for the year ended March 31, 2026 on June 29, 2026.
Management will host a live conference call on June 30, 2026 at 11:30 AM EDT to discuss financial and operating results and provide a corporate update. Investors can join using domestic dial-in 1-800-346-7359 or international 1-973-528-0008 with conference number 98840, and are invited to email questions in advance.
Elite Pharmaceuticals reported positive results from a pivotal bioequivalence study for an undisclosed generic anticonvulsant. The study showed the generic is bioequivalent to the branded drug, meaning it delivers the same amount of active ingredient into the bloodstream under the test conditions.
The trial used an open-label, randomized, two-period crossover design in healthy adults under fasting conditions, which is a standard approach for bioequivalence work. Elite is now compiling the data to file an Abbreviated New Drug Application with the US Food and Drug Administration, the key regulatory step needed to market the product in the United States.
IQVIA reported combined branded and generic product sales for this market of $840 million for the twelve months ending April 2026, highlighting the commercial scale of the opportunity if Elite’s generic ultimately secures approval and market access.
Elite Pharmaceuticals, Inc. filed a Current Report to highlight that it has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for a generic drug in the anticoagulant class. The branded reference product generated $26 billion in sales for the twelve months ending March 2026, according to IQVIA, and currently has no generic competition.
The brand still has unexpired patents and regulatory exclusivities listed in the FDA’s Orange Book, so any future generic launch would depend on FDA approval and successfully addressing these protections. The press release with additional details is furnished as an exhibit and is treated as furnished, not filed, under securities laws.
Elite Pharmaceuticals, Inc. has commercially launched its generic methadone hydrochloride 5 mg and 10 mg tablets in the United States under the Elite Laboratories, Inc. label. These tablets are used for severe, persistent pain and for detoxification and maintenance treatment of opioid addiction alongside medical and social support services.
Based on IQVIA data, combined brand and generic methadone tablet products generated approximately $22 million in annual retail sales in 2025, indicating a modest but established market. Elite develops and distributes niche generic, oral controlled-release drugs from its cGMP and DEA-registered facility in Northvale, New Jersey.
Elite Pharmaceuticals, Inc. reported very strong results for the third quarter of fiscal 2026, the three months ended December 31, 2025. Consolidated revenues were $31.6 million, up $17.2 million or about 120% from the same period a year earlier. Income from operations reached $9.0 million, an increase of $7.9 million, roughly 721% higher than the prior-year quarter, driven mainly by sales of Elite’s lisdexamfetamine and naltrexone products and strong growth in Elite label products. Net income for the quarter was $18.6 million. Management will discuss these results and recent business developments on a conference call scheduled for February 18, 2026, at 11:30 EST.
Elite Pharmaceuticals reported sharply improved results for the quarter and nine months ended December 31, 2025. Total revenue reached $31.6 million this quarter and $108.1 million year‑to‑date, up from $14.4 million and $52.0 million a year earlier, driven mainly by higher manufacturing fees.
Net income was $18.6 million for the quarter versus a $10.9 million loss last year, and $26.4 million year‑to‑date versus a $21.3 million loss. Results include a sizeable non‑cash gain from changes in warrant fair value. Basic EPS was $0.02 for both the quarter and nine months.
Cash and restricted cash increased to $21.6 million from $8.7 million year‑earlier, helped by $14.6 million of operating cash flow and repayment of $4.0 million and $1.0 million of related‑party loans. One customer represented 64% of revenue and 70% of receivables, and the company continues ANDA‑focused operations while pursuing new generic launches and managing ongoing patent litigation over a proposed generic OxyContin.
Elite Pharmaceuticals, Inc. filed a current report announcing it will release financial results for the third quarter of fiscal year 2026, ended December 31, 2025, on February 17, 2026. Management will host a conference call on February 18, 2026 at 11:30 EST to discuss the results and provide a corporate update.
Investors can join the call by dialing 1-800-346-7359 (domestic) or 1-973-528-0008 (international) using conference number 98840, and are invited to email general and financial questions in advance to dianne@elitepharma.com by the specified deadlines.
Elite Pharmaceuticals executive Douglas Plassche reported an option exercise. On 01/09/2026, the EVP of Operations exercised stock options covering 2,500,000 shares of Elite Pharmaceuticals common stock at an exercise price of $0.03 per share, converting them into 2,500,000 shares of common stock.
The stock options were fully vested and exercisable as of the transaction date. Following this transaction, Plassche directly beneficially owns 6,000,000 shares of Elite Pharmaceuticals common stock and holds no remaining derivative securities from this reported option grant.
Elite Pharmaceuticals (ELTP) filed an 8-K noting it filed its Form 10‑Q for the quarter ended September 30, 2025 and issued a press release with those results. The company will host a conference call on November 17, 2025 at 11:30 AM EST to provide a business update and answer pre-submitted stockholder questions.
Dial-in: 1-800-346-7359 (domestic) or 1-973-528-0008 (international), conference number 98840. Financial questions may be emailed to dianne@elitepharma.com by 7:00 PM EST on November 14, 2025. An audio replay will be available at https://elite.irpass.com/events_presentations.
Elite Pharmaceuticals (ELTP) reported a strong Q2 FY2026. Total revenue reached $36,321,704 for the quarter, up from $18,880,345 a year ago, driven by manufacturing fees. Gross profit was $14,073,033. Income from operations rose to $8,213,746. A $7,519,649 favorable change in warrant fair value lifted other income, resulting in net income attributable to common shareholders of $13,702,407, or $0.01 per basic and diluted share.
For the six months, revenue was $76,532,801 with income from operations of $29,913,453 and net income of $7,817,692 after $7,308,441 of income tax expense. Cash was $26,617,346 as of September 30, 2025, up from $11,315,385, aided by $19,880,115 net cash from operating activities; related party loans of $4,000,000 were repaid. Accounts receivable rose to $40,871,924, and warrant liabilities were $39,789,081. Shares outstanding were 1,074,496,422 as of November 14, 2025. Subsequent to quarter end, the FDA approved Elite’s ANDA for generic Requip XL (Ropinirole ER tablets) under the Elite Laboratories label.