ELTP

MKT CAP $269.3MP/E 6.3DIV YIELD —FCF YIELD 6.51%REV TTM $141M +33.7%NET INCOME $56.7MNET CASH $5.9M52W 0.22 – 0.68SEC XBRL · TTM TO Invalid Date

How ELTP rewrote its risk factors

10-K ITEM 1A · FY2025 → FY2026

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Patents The Company owns the following patents (as of March 31, 2026): PATENT EXPIRATION DATE U.S. patent 9,056,054 June 2030 U.S. patent 10,213,388 June 2030 We intend to apply for patents for other products in the future; however, there can be no assurance that any of the pending applications or other applications which we may file will be granted.
During the year ended March 31, 2026, a patent related to the Company’s abuse deterrent opioid technology expired before marketing authorization was obtained from the FDA, and therefore all capitalized costs related to the application of this patent were impaired in full during the year ended March 31, 2026.
Refer to Note 4 of our consolidated financial statements for additional information.
On May 12, 2025, President Trump issued an executive order implementing the concept of most-favored nation (“MFN”) pricing.
Under the order, MFN pricing will apply only to brand products without generic or biosimilar competition.
As an alternative to the Affordable Care Act, President Trump announced the Great Healthcare Plan in January 2026.
As presented, the plan is intended to lower drug prices by increasing competition and benchmarking U.S. drug prices to other countries, reduce insurance premiums by redirecting subsidies from insurers to individuals, increase accountability and transparency from insurers, and promote consumer choice by giving individuals more direct control over how healthcare dollars are spent.
Legislative and regulatory action will be required to fully implement the plan.
It is unclear how these proposed changes will impact our business and the pharmaceutical industry in general.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing.
Additional reform measures may be adopted in the future Compliance with Environmental Laws We are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting emissions, waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or past generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor or in possession.
Competition The Company has competition with respect to our principal areas of operation.
We develop, manufacture and distribute generic products.
Elite’s product lines consist of solid oral dose products, both immediate-release and controlled-release, which are marketed under the Elite Labs label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations.
Our Reporting Segments We had previously determined that we operated in two segments, which were (i) products whose marketing approvals were secured via an ANDA and (ii) products whose marketing approvals were secured via an NDA.
During the year ended March 31, 2026, we determined that NDA was no longer a segment as the Company has paused further development of NDAs and has not engaged in business activities for several years and does not intend to engage in business activities related to the development of NDAs for the foreseeable future.
Therefore, as of March 31, 2026, the Company has determined that it operates in a single operating and reportable segment, which is ANDA.
For the years ended March 31, 2026 and 2025, revenue from our ANDA segment was $148.9 million and $84.0 million, respectively.
Segment information is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined to be the Chief Executive Officer, for the purpose of making decisions about allocating resources and assessing performance of the Company.
Employees As of June 25, 2026, we had 65 full-time employees.
Business Related Risks ● The pharmaceutical industry is highly competitive. ● Natural disasters and associated supply chain effects. ● Interruptions in operations at our sole facility could have a material adverse effect on our business. ● We may sell, withdraw or discontinue manufacture of certain products. ● We may fail to successfully identify, develop, and commercialize new products. ● Introduction of generic equivalents of our products by competitors. ● Our operations could be disrupted by failure of our information systems or cyber-attacks. ● Artificial intelligence (“AI”) based platforms may present new risks and challenges to our business. ● Delays in product development may result in failure to achieve adequate return on investment. ● Our business is dependent on market acceptance of our products and social and political pressures, including public concern over the abuse of certain products, including opioids may adversely affect our business. ● Unstable economic conditions may adversely affect our business. ● We depend on qualified scientific and technical personnel and our ability to attract and retained such. ● Unsuccessful collaboration or licensing arrangements could limit revenues and product development. ● Substantial portion of revenues is derived from a limited number of products. ● We depend to a large extent on third-party suppliers and distributors for the raw materials for our products. ● Risks related to incorrect or inadequate provision for price adjustments and sales allowances Financial and Liquidity Related Risks ● We have identified material weaknesses in our internal controls over financial reporting ● While we currently qualify as a smaller reporting company under SEC regulations, we cannot be certain, if we take advantage of the reduced disclosure requirements applicable to these companies, that we will not make our stock less attractive to investors.
Once we lose smaller reporting company status, the costs and demands placed upon our management are expected to increase. ● Our operating results could fluctuate significantly. ● Our ability to fund operations is uncertain and we may require additional financing to meet objectives. ● There is a risk of impairment of significant intangible assets on our balance sheet. ● GAAP requires estimates, judgments and assumptions which inherently contain uncertainties.
Legal and Regulatory Risks ● The pharmaceutical industry is heavily regulated, which creates uncertainty and substantial compliance costs. ● Disruptions at the FDA, the DEA, the SEC, and other government agencies could negatively impact our business. ● Our business may be adversely affected by legislation or healthcare regulatory reform and initiatives. ● Use of generics may be limited through legislative, regulatory or efforts of pharmaceutical companies. ● Our revenues and profits from generic products may decline as a result of changes in regulatory policy. ● New tariffs and evolving trade policy between the US and other countries may adversely affect our business. ● The DEA could limit the availability of active ingredients used in many of our products. ● We received a CRL from the FDA indicating that the SequestOx™ NDA is not ready for approval. ● Regulatory factors may cause us to be unable to manufacture products or face interruptions in our manufacturing process. ● Agreements between branded pharmaceutical companies and generic pharmaceutical companies are facing increased government scrutiny in the United States and internationally. ● Complex reporting and payment obligations under the Medicaid rebate and other governmental programs. ● Investigations and litigation concerning the calculation of average wholesale prices may adversely affect our business Litigation and Liability Related Risks ● We may not be able to obtain or maintain adequate insurance coverages. ● Litigation, product liability claims, product recalls, government investigations and other significant legal proceedings are common in the pharmaceutical industry. ● We are subject to various fraud and abuse laws which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings. ● Our products contain controlled substances which may subject us to increased litigation risk and regulation. ● Mandatory REMS programs could increase the cost, burden, and liability associated with the commercialization of certain products. ● Illegal distribution and third-party sale of counterfeit versions of our products could have a detrimental effect on our reputation and business. ● Competitors or other third parties may allege that we are infringing upon their intellectual property.
Risks Related to our Common Shares ● Dilution from issuance of shares pursuant to the exercise of warrants and options or the perception that dilution may occur could cause the price per share of common stock to fall. ● Our common stock is a penny stock, quoted on the OTC bulletin board, with rules in place that could limit trading and liquidity of our shares, increased transaction costs that could adversely affect our price per share. ● Shareholder activism could negatively affect us. ● Our stock price has been volatile. ● Capital raises through sales of securities may cause substantial dilution to existing shareholders. ● Issuance of shares of common or preferred stock could make achieving a change of control more difficult. ● We have no plans to pay regular dividends or conduct ordinary share purchases.
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 impacted the operation of healthcare systems, global travel, supply and labor markets and other business and economic activity worldwide, had a disruptive and adverse impact on our financial condition and results of operations and on those of many of the third parties on which we rely.
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 condition.
We will also work with our internal teams and the third-parties on which we rely to assess, and seek to mitigate, the potential impacts on our business operations and financial condition of any future outbreaks of contagious diseases or other adverse public health developments that may emerge from time to time.
However, as other generic manufacturers receive regulatory approvals for their own generic versions, that market share, and the price of that product, will typically decline depending on several factors, including, without limitation, the number of competitors, the price of the branded product and the pricing strategy of the new competitors.
We currently hold four approved ANDAs for opioid products.
For the year ended March 31, 2026, our significant product families (defined as the top four products based on active pharmaceutical ingredient) accounted for in excess of 75% of allocated revenues (defined as gross revenues less chargebacks and government rebates processed).
For the year ended March 31, 2026, our six largest customers accounted for in excess of 75% of revenues.
This Annual Report on Form 10-K reports annual revenues for the fiscal year ended March 31, 2026 in excess of $100 million.
We therefore expect to no longer qualify for smaller reporting company status in the near future.
Our operating results could fluctuate significantly.
In addition, we have been in operation since 1990, and were not profitable until the fiscal year ended March 31, 2021.
In certain years prior to the fiscal year ended March 31, 2021, the auditor’s opinion on our financial statements was qualified with respect to there being substantial doubt as to the Company’s ability to continue as a going concern due to continued losses not being sufficiently offset by operating revenues.
There can be no assurances of our ability to sustain current profitability and a failure to generate sufficient revenues to offset related costs of operations will have a material adverse effect on our business, results of operations, financial condition, cash flow and ability to operate.
Our ability to fund and grow operations is uncertain and we may require additional financing to meet objectives.
Our ability to fund current operations, maintain liquidity and execute growth plans is reliant on resources generated from our operations, which are subject to significant risks and uncertainties.

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Gone since FY2025

Patents The Company owns the following patents (as of March 31, 2025): PATENT EXPIRATION DATE U.S. patent 9,056,054 June 2030 U.S. patent 10,213,388 June 2030 We intend to apply for patents for other products in the future; however, there can be no assurance that any of the pending applications or other applications which we may file will be granted.
On May 12, 2025, President Trump issued an executive order implementing the concept of most-favored nation pricing.
Under the order, most-favored nation pricing will apply only to brand products without generic or biosimilar competition.
Compliance with Environmental Laws We are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting emissions, waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or past generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor or in possession.
Competition We have competition with respect to our principal areas of operation.
We develop and manufacture generic products, products using controlled-release drug technology, products utilizing abuse-deterrent technologies, and we develop and market (either on our own or by license to other companies) generic and proprietary controlled-release and abuse-deterrent pharmaceutical products.
In both areas, our competition consists of those companies which develop controlled release, abuse-deterrent drugs and alternative drug delivery systems.
We do not represent a significant presence in the pharmaceutical industry.
An increasing number of pharmaceutical companies have become interested in the development and commercialization of products incorporating advanced or novel drug delivery systems.
Some of the major pharmaceutical companies have invested and are continuing to invest significant resources in the development of their own drug delivery systems and technologies and some have invested funds in such specialized drug delivery companies.
Many of these companies have greater financial and other resources as well as more experience than we do in commercializing pharmaceutical products.
Certain companies have a track record of success in developing controlled-release drugs.
Significant among these are, without limitation, Pfizer, Sandoz (a Novartis company), Mylan Laboratories, Inc., Endo Pharmaceuticals, Inc., Teva Pharmaceuticals Industries Ltd., Amneal Laboratories, Inc., Mallinckrodt Pharmaceuticals plc, and Aurobindo Pharma USA, Inc.
Each of these companies has developed expertise in certain types of drug delivery systems, although such expertise does not carry over to developing a controlled-release version of all drugs.
Such companies may develop new drug formulations and products or may improve existing drug formulations and products more efficiently than we can.
In addition, almost all of our competitors have vastly greater resources than we do.
While our product development capabilities and, if obtained, patent protection may help us to maintain our market position in the field of advanced drug delivery, there can be no assurances that others will not be able to develop such capabilities or alternative technologies outside the scope of our patents, if any, or that even if patent protection is obtained, such patents will not be successfully challenged in the future.
In addition to competitors that are developing products based on drug delivery technologies, there are also companies that have announced that they are developing opioid abuse-deterrent products that might compete directly or indirectly with Elite’s products.
These include, but are not limited to Pfizer Inc., Collegium Pharmaceuticals, Inc., and Purdue Pharma LP.
We also face competition in the generic pharmaceutical market.
Our Reporting Segments We currently operate in two segments, which are (i) products whose marketing approvals were secured via an ANDA and (ii) products whose marketing approvals were secured via an NDA.
For the years ended March 31, 2025 and 2024 revenue from our ANDA segment were $84.0 million and $56.6 million, respectively.
For the years ended March 31, 2025 and 2024 revenue from our NDA segment were $0.0 million and $0.0 million, respectively.
Segment information is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined to be the Chief Executive Officer, for the purposes of making decisions about allocating resources and assessing performance of the Company.
Employees As of June 25, 2025, we had 68 full-time employees.
Business Related Risks ● The pharmaceutical industry is highly competitive. ● Natural disasters and associated supply chain effects. ● Interruptions in operations at our sole facility could have a material adverse effect on our business. ● We may sell, withdraw or discontinue manufacture of certain products. ● We may fail to successfully identify, develop, and commercialize new products. ● Introduction of generic equivalents of our products by competitors. ● Our operations could be disrupted by failure of our information systems or cyber-attacks and artificial. ● Artificial intelligence (“AI”) based platforms may present new risks and challenges to our business. ● Delays in product development may result in failure to achieve adequate return on investment. ● Our business is dependent on market acceptance of our products and social and political pressures, including public concern over the abuse of certain products, including opioids may adversely affect our business. ● Unstable economic conditions may adversely affect our business. ● We depend on qualified scientific and technical personnel and our ability to attract and retained such. ● Unsuccessful collaboration or licensing arrangements could limit revenues and product development. ● Substantial portion of revenues is derived from a limited number of products. ● We depend to a large extent on third-party suppliers and distributors for the raw materials for our products. ● Risks related to incorrect or inadequate provision for price adjustments and sales allowances Financial and Liquidity Related Risks ● We have identified material weaknesses in our internal controls over financial reporting ● While we currently qualify as a smaller reporting company under SEC regulations, we cannot be certain, if we take advantage of the reduced disclosure requirements applicable to these companies, that we will not make our stock less attractive to investors.
Once we lose smaller reporting company status, the costs and demands placed upon our management are expected to increase. ● We have a relatively limited operating history and our operating results could fluctuate significantly. ● Our ability to fund operations is uncertain and we may require additional financing to meet objectives. ● We most likely will require additional financing to meet our business objectives. ● We have substantial indebtedness which may adversely affect our financial condition. ● There is a risk of impairment of significant intangible assets on our balance sheet. ● GAAP requires estimates, judgements and assumptions which inherently contain uncertainties.
Legal and Regulatory Risks ● The pharmaceutical industry is heavily regulated, which creates uncertainty and substantial compliance costs. ● Our business may be adversely affected by legislation or healthcare regulatory reform and initiatives. ● Use of generics may be limited through legislative, regulatory or efforts of pharmaceutical companies. ● Our revenues and profits from generic products may decline as a result of changes in regulatory policy. ● New tariffs and evolving trade policy between the US and other countries may adversely affect our business. ● The DEA could limit the availability of active ingredients used in many of our products. ● We received a CRL from the FDA indicating that the SequestOx™ NDA is not ready for approval. ● Regulatory factors may cause us to be unable to manufacture products or face interruptions in our manufacturing process. ● Agreements between branded pharmaceutical companies and generic pharmaceutical companies are facing increased government scrutiny in the United States and internationally. ● Complex reporting and payment obligations under the Medicaid rebate program. ● Investigations and litigation concerning the calculation of average wholesale prices may adversely affect our business Litigation and Liability Related Risks ● We may not be able to obtain or maintain adequate insurance coverages. ● Litigation, product liability claims, product recalls, government investigations and other significant legal proceedings are common in the pharmaceutical industry. ● We are subject to various fraud and abuse laws which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings. ● Our products contain controlled substances which may subject us to increased litigation risk and regulation. ● Mandatory REMS programs could increase the cost, burden, and liability associated with the commercialization of certain products. ● Illegal distribution and third-party sale of counterfeit versions of our products could have a detrimental effect on our reputation and business. ● Competitors or other third parties may allege that we are infringing upon their intellectual property.
Risks Related to our Common Shares ● Dilution from issuance of shares to Lincoln Park Capital Fund, LLC, Directors, Employees, Consultants or upon exercise of warrants and options or the perception that dilution may occur could cause the price per share of common stock to fall. ● Our common stock is a penny stock, quoted on the OTC bulletin board, with rules in place that could limit trading and liquidity of our shares, increased transaction costs that could adversely affect our price per share. ● Shareholder activism could negatively affect us. ● Our stock price has been volatile. ● Capital raises through sales of securities may cause substantial dilution to existing shareholders. ● Issuance of shares of common or preferred stock could make achieving a change of control more difficult. ● We have no plans to pay regular dividends or conduct ordinary share purchases.
However, as other generic manufacturers receive regulatory approvals for their own generic versions, that market share, and the price of the that product, will typically decline depending on several factors, including, without limitation, the number of competitors, the price of the branded product and the pricing strategy of the new competitors.
We currently hold four approved ANDAs for opioid products, with three of these being commercially sold and one to be commercially launched within a timeframe that is beneficial to the Company’s interests.
For the year ended March 31, 2025, our significant product families (defined as the top four products based on active pharmaceutical ingredient) accounted for in excess of 90% of allocated revenues (defined as gross revenues less chargebacks and government rebates processed).
For the year ended March 31, 2025, our six largest customers accounted for in excess of 80% of revenues.
We have a relatively limited operating history and our operating results could fluctuate significantly.
In addition, although we have been in operation since 1990, we have a relatively short operating history, have only achieved profitability for the first time during the fiscal year ended March 31, 2021 and limited financial data upon which you may evaluate our business and prospects.
There can be no assurances of our ability to sustain current profitability.
Additionally, in certain years prior to the year ended March 31, 2021, the auditor’s opinion on our financials was qualified with respect to there being substantial doubt as to the Company’s ability to continue as a going concern due to continued losses not being sufficiently offset by operating revenues.
A failure to generate sufficient revenues to offset related costs of operations will have a material adverse effect on our business, results of operations, financial condition, cash flow and ability to operate.
Our ability to fund operations is uncertain and we may require additional financing to meet objectives.
Our ability to fund our operations, maintain liquidity and meet our financing obligations is reliant on our operations, which are subject to significant risks and uncertainties.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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