ELTP 最新10-K变化

相对上期新增的文字 · 来源:10-K · 2026-06-29

• Methadone Hydrochloride 5mg and 10mg tablets (“Methadone 5mg” and “Methadone 10mg”) Dolophine® Pain April 2026

• Sales and marketing rights for Phentermine 37.5mg relating to the approved ANDA acquired in 2010 were licensed under an agreement between the Company and Precision Dose Inc. (“Precision Dose”) dated September 10, 2010 (the “Precision Dose License Agreement”) and the Precision Dose License Agreement …

• Phentermine 15mg and Phentermine 30mg are currently commercial products being manufactured at the Northvale Facility and distributed by Elite Labs.

• Naltrexone 50mg is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite Labs.

• On December 6, 2021, the Company executed a license and distribution agreement with Dexcel Ltd (or Akiva, Israel) (“Dexcel”), pursuant to which the Company manufactures and supplies Amphetamine IR Tablets to Dexcel and Dexcel is granted exclusive distribution rights for the Israeli market for this p…

相对上期删除的文字 · 来源:10-K · 2025-06-30

• Product Branded Product Equivalent Therapeutic Category Launch Date

• Vigabatrin Powder 500mg (“Vigabatrin 500mg”) Sabril® Anti-epileptic January 2024

• Oxycodone Hydrochloride and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325” and “Oxy APAP 10/325”) Percocet® Pain April 2025 (Subsequent to year-end)

• Sales and marketing rights for Phentermine 37.5mg relating to the approved ANDA acquired in 2010 are included in the licensing agreement between the Company and Precision Dose Inc. (“Precision Dose”) dated September 10, 2010 (the “Precision Dose License Agreement”). Please see the section below titl…

• During the year ended March 31, 2025, the Company withdrew the ANDA for Phentermine 37.5mg capsules from the market as it did not intend to engage in commercial operations with this product. As a result, the Company recognized an impairment on this product.

相对上期新增的文字 · 来源:10-K · 2026-06-29

• ● Disruptions at the FDA, the DEA, the SEC, and other government agencies could negatively impact our business.

• In addition, outbreaks of contagious diseases and other adverse public health developments affecting us and/or the third parties on which we rely could have a material and adverse effect on our business, financial condition and results of operations. For example, the COVID-19 pandemic, which impacte…

• Although the acute COVID-19 public health emergency has lapsed, we will continue to monitor its long-term impacts, including impacts on market practices and on the labor market, and adjust our policies and practices as needed to mitigate any adverse impacts to our business operations and financial c…

• As of March 31, 2026, we had cash on hand of approximately $30 million and a working capital of approximately $95 million, and for the year ended March 31, 2026, we generated income from operations totaling approximately $49 million, net other income totaling approximately $8 million and a net tax e…

• Disruptions at the FDA, the DEA, the SEC and other government agencies could negatively impact our business.

相对上期删除的文字 · 来源:10-K · 2025-06-30

• ● We have a relatively limited operating history and our operating results could fluctuate significantly.

• ● We most likely will require additional financing to meet our business objectives.

• ● We have substantial indebtedness which may adversely affect our financial condition.

• We have a relatively limited operating history and our operating results could fluctuate significantly.

• We most likely will require additional financing to meet our business objectives.

相对上期新增的文字 · 来源:10-K · 2026-06-29

• On August 17, 2023, Elite filed a Paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November 14, 2023, a patent i…

• Elite’s launch of a generic Oxycontin will depend on approval by the FDA and the outcome of various litigation involving Purdue or the expiry of the patents listed on the Orange Book.

相对上期删除的文字 · 来源:10-K · 2025-06-30

• On August 17, 2023, Elite filed a Paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November 14, 2023, a patent i…

相对上期新增的文字 · 来源:10-K · 2026-06-29

• Total revenues for the year ended March 31, 2026 increased by $64.8 million or 77%, to $148.9 million, as compared to $84.0 million, for the comparable period of the prior year. This increase is primarily due to revenue from sales of Oxy APAP tablets launched during the current fiscal year, Naltrexo…

• Our gross profit margin was 50% during the year ended March 31, 2026 as compared to 48% during the prior fiscal year. The increase is due to product mix in the current fiscal year including greater proportion of higher margin products.

• Impairment of intangible assets for the year ended March 31, 2026 was $0.8 million as compared to $1.6 million for the prior fiscal year, a decrease of $0.8 million or approximately 47%. This decrease is related to impairments of ANDAs for Loxapine Capsules and patent development costs during the cu…

• Other income (expense) for the year ended March 31, 2026 was an other income of $7.7 million, an increase in net other income (expense) of $27.4 million from other (expense) of $19.7 million for the comparable period of the prior year. The increase was primarily due to increases in other income of $…

• Income tax expense for the year ended March 31, 2026 was $11.9 million as compared to $4.3 million for the year ended March 31, 2025, an increase of $7.6 million or 180%. The increase was due to the Company’s net income before income taxes being approximately $56.9 million greater this year than the…

相对上期删除的文字 · 来源:10-K · 2025-06-30

• Total revenues for the year ended March 31, 2025 increased by $27.4 million or 48%, to $84.0 million, as compared to $56.6 million, for the comparable period of the prior year. This increase is primarily due to four product launches during the current fiscal year combined with increased sales from t…

• Our gross profit margin was 48% during the year ended March 31, 2025 as compared to 47% during the prior fiscal year. The increase is due to increased manufacturing volumes resulting in decreased unit costs due to efficiencies of scale being achieved on the increased manufacturing volume as well as …

• Impairment of intangible assets for the year ended March 31, 2025 was $1.6 million related to the impairment of the Dantrolene intangible asset, an ANDA product, as a result of the Company choosing to abandon the Dantrolene capsules based on reassessments of the expected future cash flows for these …

• Other income (expense) for the year ended March 31, 2025 was an other expense of $19.7 million, an increase in net other (expense) of $9.3 million from other (expense) of $10.3 million for the comparable period of the prior year. The increase was primarily due to increases in other expenses of $13.1…

• The Company considers cash and working capital balances as several of the factors the Company uses in evaluating its performance. As of March 31, 2025, the Company had cash on hand of $11.3 million and accounts receivable to be collected within expected operating cycles of $29.2 million. The Company…