What the changes say
- Fiscal 2026 sales fell 16% to $4.453 million, with distributor ordering and international shipment timing contributing.
- Cash is insufficient for the next 12 months, and auditors continue substantial doubt about going concern.
- New risks emphasize AI-enabled diagnostics, outsourced ERP and cybersecurity failures, and a Nasdaq $5 million MVLS rule.
- Distributor concentration, tariffs, product acceptance, regulatory authorizations, and financing-related dilution remain important exposures.
What changed since the prior 10-K
New
- NewRISKS RELATED TO OUR BUSINESS
Our revenues have declined, and there is no assurance that we will reverse this trend
Sales declined 16% to $4.453 million, increasing risks of operating losses, cash use, financing dependence, and competitive pressure.
- NewRISKS RELATED TO OUR BUSINESS
Advances in artificial intelligence and competing diagnostic technologies could reduce demand for our products
AI-enabled diagnostics and competing technologies could reduce demand, while evolving regulation and intellectual-property claims may raise adaptation and litigation costs.
- NewRISKS RELATED TO OUR BUSINESS
Failures in our information technology and storage systems or data security breaches could significantly disrupt our business or force us to expend excessive costs
Outsourced ERP and other information systems could disrupt orders, shipments, invoicing, payments, customer support, and operations, including through cyberattacks.
- NewRISKS RELATED TO OUR BUSINESS
Nasdaq ’s recently adopted minimum Market Value of Listed Securities requirement of $5 million could result in the suspension and delisting of our common stock from Nasdaq
Nasdaq’s new $5 million MVLS rule could suspend and delist the stock after 30 business days below the threshold, although the rule is stayed.
Dropped
- DroppedRISKS RELATED TO OUR BUSINESS
Failures in our information technology and storage systems, many of which are outsourced to third parties, could significantly disrupt our business and incur excessive costs
Reworded
- 94% rewrittenRISKS RELATED TO OUR BUSINESS
If our competitors’ products prove to be more effective or capture market share through superior marketing or competitive pricing, our sales and margins could suffer. This intense competition could materially and adversely affect our operating results
The intellectual-property and third-party claims discussion was removed; the risk now focuses on industry consolidation and competitive pressure.
- 75% rewrittenRISKS RELATED TO OUR BUSINESS
Our ability to use our net operating loss carry forwards in the future may be subject to limitation
Federal carryforwards increased to $32.381 million and California carryforwards to $30.381 million, with limitations and expiration provisions now emphasized.
- 68% rewrittenRISKS RELATED TO OUR BUSINESS
Although our financial statements have been prepared on a going concern basis, our current level of cash and cash equivalents is not sufficient to meet our operating plans for the next 12 months, raising substantial doubt regarding our ability to continue as a going concern
The risk now states that existing cash cannot fund the next 12 months and highlights recurring losses, negative operating cash flow, and auditor doubt.
Was: Although our financial statements have been prepared on a going concern basis, our current level of cash and cash equivalents available to us is not sufficient to meet our operating plans for the next 12 months, raising substantial doubt regarding our ability to continue as a going concern
- 67% rewrittenRISKS RELATED TO OUR BUSINESS
Tariffs and trade dynamics may affect order timing
Tariffs and trade uncertainty now include order cancellations by foreign vendors or customers, affecting total revenue as well as shipment timing.
- 63% rewrittenRISKS RELATED TO OUR BUSINESS
Our net sales were approximately $4,453,000 for the fiscal year ended May 31, 2026, compared to $5,311,000 for the fiscal year ended May 31, 2025. For each of the fiscal years ended May 31, 2026 and 2025, our largest distributor accounted for 31% of our net sales
Receivables concentration declined to three distributors representing 59%, while two North American distributors account for 34%; fiscal 2026 sales were $4.453 million.
Was: Our net sales were approximately $5,311,000 for fiscal year ended May 31, 2025, compared to $5,415,000 for fiscal year eneded May 31, 2024. For the fiscal years ended May 31, 2025 and 2024, the Company had one distributor each year that accounted for 31% and 33% of our net sales, respectively
- 62% rewrittenRISKS RELATED TO OUR BUSINESS
Sales of our common stock in the public market could lower the market price for our common stock and adversely impact the trading price of our securities
The $20 million shelf registration is now described as replacing the expiring prior registration, with effectiveness and filing history clarified.
- 59% rewrittenRISKS RELATED TO OUR BUSINESS
There is also no guarantee that our new products, including our inFoods® IBS product and hp+detect ™ , will be well accepted into the marketplace
Specific inFoods IBS, hp+detect, and EU IVDR concerns were replaced by broader risks around obtaining and maintaining regulatory authorizations.
- 58% rewrittenRISKS RELATED TO OUR BUSINESS
Fluctuations in our operating results, for any reason, could cause increased operating losses as a result of significant fixed expenses
The wording was lightly updated from expected revenue shortfalls to possible shortfalls; the fixed-cost and operating-loss risk is materially unchanged.
Was: Fluctuations in our operating results, for any reason, could cause operating losses as a result of significant fixed expenses
- 54% rewrittenRISKS RELATED TO OUR BUSINESS
We also have supply agreements with foreign vendors that involve sharing foreign currency exchange fluctuation risks. We may enter into similar arrangements in the future
- 53% rewrittenRISKS RELATED TO OUR BUSINESS
Our operating results may fluctuate adversely as a result of many factors that are outside our control, which could adversely affect our business and the market price of our common stock
Was: Our operating results may fluctuate adversely as a result of many factors that are outside our control, which may negatively impact our stock price
- 43% rewrittenRISKS RELATED TO OUR BUSINESS
We have a history of operating losses and negative cash flows from operations
Was: We have a history of operating losses
- 43% rewrittenRISKS RELATED TO OUR BUSINESS
Our total revenue could be affected by third-party reimbursement policies and potential cost constraints
- 35% rewrittenRISKS RELATED TO OUR BUSINESS
Our business could be negatively affected by the loss of or the inability to hire key personnel
- 34% rewrittenRISKS RELATED TO OUR BUSINESS
We also have a number of stockholders who own large blocks of our common stock. If one or more of these stockholders were to sell large portions of their holdings in a relatively short time, for liquidity or other reasons, the prevailing market price of shares of our common stock could be negatively affected
- 30% rewrittenRISKS RELATED TO OUR BUSINESS
We maintain a manufacturing plant in Mexico which presents risks to us including risks associated with doing business outside the United States
Was: The Company maintains a manufacturing plant in Mexico which presents risks to the Company including risks associated with doing business outside the United States
- 27% rewrittenRISKS RELATED TO OUR BUSINESS
If one or more of our products is claimed to be defective or does not meet the performance criteria we claim in our marketing materials, we could be subject to product recalls, claims of liability, harm to patients or users of our products, or harm to our reputation that could adversely affect our business
- 23% rewrittenRISKS RELATED TO OUR BUSINESS
We face risks relating to our international sales, including inherent economic, political, and regulatory risks, which could impact our financial performance, cause interruptions in our current business operations and impede our growth strategy
Was: We face risks relating to our international sales, including economic, political, and regulatory challenges, which could impact our financial performance, disrupt our business operations, and hinder our growth strategy
- 22% rewrittenRISKS RELATED TO OUR BUSINESS
We need to continue to raise additional funds to finance our future capital or operating needs, which could have adverse consequences on our operations and the interests of our stockholders
All 35 risk factors
Headings as the filing states them, in filing order.
RISKS RELATED TO OUR BUSINESS
- 01We have a history of operating losses and negative cash flows from operations43% rewritten
- 02Although our financial statements have been prepared on a going concern basis, our current level of cash and cash equivalents is not sufficient to meet our operating plans for the next 12 months, raising substantial doubt regarding our ability to continue as a going concern68% rewritten
- 03Our operating results may fluctuate adversely as a result of many factors that are outside our control, which could adversely affect our business and the market price of our common stock53% rewritten
- 04Fluctuations in our operating results, for any reason, could cause increased operating losses as a result of significant fixed expenses58% rewritten
- 05Our revenues have declined, and there is no assurance that we will reverse this trendNew
- 06To remain competitive, we must expend considerable resources to research new technologies and products and develop new markets, and there is no assurance our efforts to develop new technologies, products, or markets will be successful or such technologies, products, or markets will be commercially viable
- 07There is also no guarantee that our new products, including our inFoods® IBS product and hp+detect ™ , will be well accepted into the marketplace59% rewritten
- 08We maintain a manufacturing plant in Mexico which presents risks to us including risks associated with doing business outside the United States30% rewritten
- 09We use hazardous materials in our research and production that may result in unexpected and substantial claims against us relating to handling, storage, or disposal
- 10Our net sales were approximately $4,453,000 for the fiscal year ended May 31, 2026, compared to $5,311,000 for the fiscal year ended May 31, 2025. For each of the fiscal years ended May 31, 2026 and 2025, our largest distributor accounted for 31% of our net sales63% rewritten
- 11We face risks relating to our international sales, including inherent economic, political, and regulatory risks, which could impact our financial performance, cause interruptions in our current business operations and impede our growth strategy23% rewritten
- 12We also have supply agreements with foreign vendors that involve sharing foreign currency exchange fluctuation risks. We may enter into similar arrangements in the future54% rewritten
- 13Tariffs and trade dynamics may affect order timing67% rewritten
- 14Our results of operations and financial conditions may be adversely affected by the financial soundness of our customers, distributors, and suppliers
- 15We extend credit to customers outside the United States which can be difficult to collect
- 16If we are not able to manage our growth strategy our operating results may be adversely affected
- 17The industry and market segments in which we operate are highly competitive, and intense competition with other providers of diagnostic products may reduce our sales and margins
- 18If our competitors’ products prove to be more effective or capture market share through superior marketing or competitive pricing, our sales and margins could suffer. This intense competition could materially and adversely affect our operating results94% rewritten
- 19Advances in artificial intelligence and competing diagnostic technologies could reduce demand for our productsNew
- 20We need to continue to raise additional funds to finance our future capital or operating needs, which could have adverse consequences on our operations and the interests of our stockholders22% rewritten
- 21Changes in government policy could adversely affect our business and potential profitability
- 22We are subject to numerous government regulations in addition to FDA regulations, and compliance with laws, including changed or new laws, could increase our costs and adversely affect our operations. There is also the risk that our facilities could fail to get the proper licensing at our next inspection or renewal
- 23Our total revenue could be affected by third-party reimbursement policies and potential cost constraints43% rewritten
- 24Unexpected increases in, or inability to meet, demand for our products could require us to spend considerable resources to meet the demand or harm our reputation and customer relationships if we are unable to meet demand
- 25If one or more of our products is claimed to be defective or does not meet the performance criteria we claim in our marketing materials, we could be subject to product recalls, claims of liability, harm to patients or users of our products, or harm to our reputation that could adversely affect our business27% rewritten
- 26We are exposed to business risks which, if not covered by insurance, could have an adverse effect on our results of operations. We face potential product liability exposure, and, if claims brought against us are successful, we could incur substantial liabilities
- 27Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of studies and trials may not be predictive of future trial results
- 28We may rely on third parties to conduct or be part of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to seek or obtain regulatory approval for or commercialize our product candidates
- 29Failures in our information technology and storage systems or data security breaches could significantly disrupt our business or force us to expend excessive costsNew
- 30Our business could be negatively affected by the loss of or the inability to hire key personnel35% rewritten
- 31Sales of our common stock in the public market could lower the market price for our common stock and adversely impact the trading price of our securities62% rewritten
- 32We also have a number of stockholders who own large blocks of our common stock. If one or more of these stockholders were to sell large portions of their holdings in a relatively short time, for liquidity or other reasons, the prevailing market price of shares of our common stock could be negatively affected34% rewritten
- 33The price of our stock may fluctuate unpredictably in response to factors unrelated to our operating performance
- 34Nasdaq ’s recently adopted minimum Market Value of Listed Securities requirement of $5 million could result in the suspension and delisting of our common stock from NasdaqNew
- 35Our ability to use our net operating loss carry forwards in the future may be subject to limitation75% rewritten
Other Biomerica 10-Ks
- FY2025 10-K risk factors32 risks
Auditor issued a going concern doubt as cash does not cover the next 12 months of operations. Net sales were $5,311,000 for fiscal 2025, down from $5,415,000 in fiscal 2024. A single distributor accounted for 31 percent of net sales in fiscal 2025. Federal net operating loss carryforwards total approximately $28,378,000.
Filed Aug 29, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.