08/07/2025 | Press release | Distributed by Public on 08/07/2025 14:39
Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion should be read in conjunction with our condensed financial statements and notes thereto included in Item 1 of Part I of this Quarterly Report on Form 10-Q. This discussion includes forward-looking statements about our business, financial condition and results of operations including discussions about management's expectations for our business. These statements represent projections, beliefs and expectations based on current circumstances and conditions and in light of recent events and trends, and these statements should not be construed either as assurances of performances or as promises of a given course of action. Instead, various known and unknown factors are likely to cause our actual performance and management's actions to vary, and the results of these variances may be both material and adverse.
Business Overview
Nephros is a commercial-stage company that develops and markets high-performance water filtration solutions, with a core focus on medical-grade water filtration. Our portfolio includes two primary product lines: infection control and dialysis water. The infection control segment features both microfilters (0.1 micron) and ultrafilters (0.005 micron), used to help prevent infections from waterborne pathogens such as Legionella and Pseudomonas. The dialysis segment consists exclusively of ultrafilters designed to remove biological contaminants, particularly endotoxins, from water and bicarbonate concentrate used in dialysis treatment. All of our medical-grade filters are FDA 510(k)-cleared as Class II medical devices-a distinguishing feature that affirms their validated safety and performance in critical-use environments. While these filters are widely used in healthcare settings, they have also been adopted across a range of other industries-including manufacturing, laboratories, aviation, and federal facilities-where water quality is essential to operational safety and compliance.
In addition, we offer a line of commercial water filters that improve taste and odor, reduce biofilm formation and scale buildup, and remove cysts, particulates, and soluble lead from water systems. These products are broadly applicable across industries and are especially valuable when used in tandem with our medical-grade filters to deliver comprehensive water-quality protection. Whether in clinical care, industrial operations, or public infrastructure, Nephros solutions support the universal need for safe, high-quality water.
Our Products
Water Filtration Products
We develop and sell water filtration products used in both medical and commercial applications. Our water filtration products employ multiple filtration technologies, as described below.
In medical markets, our primary filtration mechanism is to pass liquids through the pores of polysulfone hollow fiber. Our filters' pores are significantly smaller than those of competing products, resulting in highly effective elimination of waterborne pathogens, including legionella bacteria (the cause of Legionnaires disease) and viruses, which are not eliminated by most other microbiological filters on the market. Additionally, the fiber structure and pore density in our hollow fiber enables significantly higher flow rates than in other polysulfone hollow fiber.
Our primary sales strategy in medical markets is to sell through distributors (also termed as value-added resellers, or "VARs"). Leveraging VARs has enabled us to rapidly expand our access to target customers with limited sales staff expansion. In addition, while we are currently focused on medical markets, the VARs that support these customers also support a wide variety of commercial and industrial customers. We believe that our VAR relationships have and will continue to facilitate growth in filter sales outside of the medical industry. In addition to VARs, we also utilize a direct salesforce that targets key geographic regions throughout the country, as well as focuses on the hospital and dialysis markets.
In commercial markets, we develop and sell our filters, for which carbon-based absorption is the primary filtration mechanism. These products allow us to improve water's odor and taste, to reduce scale and heavy metals, and to reduce other water contaminants for customers who are primarily in the food service, convenience store, and hospitality industries. These commercial products are also sold into medical markets, as supplemental filtration to our medical filters.
In commercial markets, our model combines both direct and indirect sales. Through our employee sales staff, we have sold products directly to a number of convenience stores, hotels, casinos, and restaurants. We have also engaged a non-exclusive distributor to resell certain of our water filters and related products to end customers in the commercial food and beverage markets.
Target Markets
Our ultrafiltration products currently target the following markets:
| ● | Hospitals and Other Healthcare Facilities: Filtration of water for washing and drinking as an aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures, and washing of surgeons' hands. | |
| ● | Dialysis Centers and Home/Portable Dialysis Machines: Filtration of water or bicarbonate concentrate used in hemodialysis. | |
| ● | Commercial Facilities: Filtration and purification of water for consumption, including for use in ice machines and soft drink dispensers. |
Hospitals and Other Healthcare Facilities. Nephros filters are a leading tool used to provide proactive protection to patients in high-risk areas (e.g., ice machines, surgical rooms, NICUs) and reactive protection to patients in broader areas during periods of water pathogen outbreaks. Our products are used in hundreds of medical facilities to aid in infection control, both proactively and reactively.
As of 2023, according to the American Hospital Association, there are approximately 6,129 hospitals in the U.S., with approximately 920,000 beds. Over 34 million patients were admitted to these hospitals. The U.S. Centers for Disease Control and Prevention ("CDC") estimates that healthcare associated infections ("HAI") occur in approximately 1 out of every 31 hospital patients, which calculates to over one million patients in 2023. HAIs affect patients in hospitals or other healthcare facilities and are not present or incubating at the time of admission. They also include infections acquired by patients in the hospital or facility, but appearing after discharge, and occupational infections among staff. Many HAIs are caused by waterborne bacteria and viruses that can thrive in aging or complex plumbing systems often found in healthcare facilities.
In January 2022, the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services ("CMS") expanded its requirements - originally implemented in 2017 - for facilities to develop policies and procedures that inhibit the growth and spread of legionella and other opportunistic pathogens in building water systems. In this 2022 update, CMS requires teams to be assigned to the development of formal water management plans ("WMPs"), as well as detailed documentation regarding the development of the WMPs and their execution. CMS surveyors regularly review policies, procedures, and reports documenting water management implementation results to verify that facilities are compliant with these requirements. These policies must be in accordance with The American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 188-2015 and the CDC toolkit. Facilities must regularly monitor water systems and take corrective actions when needed to ensure safe water for patients, residents and visitors. We believe that these CMS regulations may have a positive impact on the sale of our HAI-inhibiting ultrafilters.
We currently have FDA 510(k) clearance on the following portfolio of medical device products for use in the hospital setting to aid in infection control:
| ● | The DSU-H and SSU-H are in-line, 0.005-micron ultrafilters that provide dual- and single-stage protection, respectively, from waterborne pathogens. They are primarily used to filter potable water feeding ice machines, sinks, and medical equipment, such as endoscope washers and surgical room humidifiers. The DSU-H has an up to 6-month product life in a typical hospital setting, while the SSU-H has an up to 3-month product life. |
| ● | The S100 is a point-of-use, 0.01-micron microfilter that provides protection from waterborne pathogens. The S100 is primarily used to filter potable water feeding sinks and showers. The S100 has an up to 3-month product life when used in a hospital setting. |
| ● | The HydraGuardTM and HydraGuardTM - Flush are 0.005-micron cartridge ultrafilters that provide single-stage protection from waterborne pathogens. The HydraGuard ultrafilters are primarily used to filter potable water feeding ice machines and medical equipment, such as endoscope washers and surgical room humidifiers. The HydraGuard has an up to 6-month product life and the HydraGuard - Flush has an up to 12-month product life when used in a hospital setting. |
Our complete hospital infection control product line, including in-line, and point-of-use can be viewed on our website at https://www.nephros.com/infection-control/. We are not including the information on our website as a part of, nor incorporating it by reference into, this Quarterly Report on Form 10-Q.
Dialysis Centers - Water/Bicarbonate.In the dialysis water market, Nephros ultrafiltration products are among the highest performing products on the market. The DSU-D, SSU-D and the SSUmini have become the standard endotoxin filter in many portable reverse osmosis systems. The EndoPur®, our large-format ultrafilter targeted at dialysis clinic water systems, provides the smallest pore size available.
To perform hemodialysis, all dialysis clinics have dedicated water purification systems to produce water and bicarbonate concentrate, two essential ingredients for making dialysate, the liquid that removes waste material from the blood. According to the American Journal of Kidney Diseases, there are approximately 7,100 dialysis clinics in the United States servicing approximately 500,000 patients annually. We estimate that there are over 100,000 hemodialysis machines in operation in the United States.
We currently have FDA 510(k) clearance on the following portfolio of medical device products for use in the dialysis setting to aid in bacteria, virus, and endotoxin retention:
| ● | The DSU-D, SSU-D and SSUmini are in-line, 0.005-micron ultrafilters that provide protection from bacteria, viruses, and endotoxins. All of these products have an up to 12-month product life in the dialysis setting and are used to filter water following treatment with a reverse osmosis ("RO") system, and to filter bicarbonate concentrate. These ultrafilters are primarily used in the water lines and bicarbonate concentrate lines leading into dialysis machines, and as a polish filter for portable RO machines. | |
| ● | The EndoPur is a 0.005-micron cartridge ultrafilter that provides single-stage protection from bacteria, viruses, and endotoxins. The EndoPur has an up to 12-month product life in the dialysis setting and is used to filter water following treatment with an RO system. More specifically, the EndoPur is used primarily to filter water in large RO systems designed to provide ultrapure water to an entire dialysis clinic. The EndoPur is a cartridge-based, "plug and play" market entry that requires no plumbing at installation or replacement. The EndoPur is available in 10", 20", and 30" configuration. |
Commercial and Industrial Facilities.Our commercial NanoGuard® product line accomplishes ultrafiltration via small pore size (0.005 micron) technology, filtering bacteria and viruses from water. In addition, our commercial filtration offerings include technologies that are primarily focused on improving odor and taste and on reducing scale and heavy metals from filtered water.
Our commercial market focus is on the hotel, restaurant, and convenience store markets. In March 2022, we entered into an agreement with Donastar LLC to provide water filtration systems to an organization that services approximately 3,000 Quick Service Restaurants ("QSR"). Effective January 1, 2023, we entered into a new supply agreement with Donastar, which superseded the March 2022 agreement. Under the January 2023 agreement, we engaged Donastar to be our exclusive distributor to the food, beverage and hospitality industries. Effective September 2024, we ended our exclusive relationship with Donastar. Although Donastar continues to distribute our products on a non-exclusive basis, we are expanding our distribution in the commercial market in order to pursue other national accounts, which, over time, may result in step-change increases in commercial market revenue.
Over time, we believe that the same water safety management programs currently underway at medical facilities may migrate to commercial markets. As the epidemiology of waterborne pathogens expands, links to contamination sources will become more efficient and the data more readily available. In cases where those sources are linked to restaurants, hotels, office buildings and residential complexes, the corporate owners of those facilities will likely face increasing liability exposure. We expect that building owners will come to understand ASHRAE-188, which outlines risk factors for buildings and their occupants, and provides water safety management guidelines. We believe, in time, most commercial buildings will need to follow the basic requirements of ASHRAE-188: create a water management plan, perform routine testing, and establish a plan to treat the building in the event of a positive test.
As demand for water testing and microbiological filtration grows, we will be ready to deploy our expertise and solutions based on years of experience servicing the medical market. We believe that we have an opportunity to offer unique expertise and products to the commercial market, and that our future revenue from the commercial market could even surpass our infection control revenue.
We currently market the following portfolio of proprietary products for use in the commercial, industrial, and food service settings:
| ● | The NanoGuard set of products are in-line, 0.005-micron ultrafilter that provides dual-stage retention of any organic or inorganic particle larger than 15,000 Daltons. NanoGuard products are designed to fit a variety of existing plumbing configurations, including 10" and 20" standard housings, and Nephros and Everpure® manifolds. Included in the NanoGuard product line are both conventional and flushable filters. | |
| ● | The Nephros line of commercial filters provide a variety of technology solutions that improve water quality in food service, convenience store, hospitality, and industrial applications. Nephros filters improve water taste and odor, and reduce sediment, dirt, rust particles and other solids, chlorine and heavy minerals, lime scale build-up, and both particulate lead and soluble lead. |
Nephros commercial products combine effectively with NanoGuard ultrafiltration technologies to offer full-featured solutions to the commercial water market, including to existing users of Everpure filter manifolds.
Critical Accounting Policies
For the six-month period ended June 30, 2025, there were no significant changes to our critical accounting policies as identified in our Annual Report on Form 10-K for the year ended December 31, 2024.
Revenue Recognition
A majority of our revenue is product sales which is recognized at a point-in-time when the product is shipped via external logistics providers and the other criteria of ASC 606 are met. Product revenue is recorded net of variable consideration which includes prompt pay discounts, other discounts, and returns and allowances.
In addition to product revenue, the Company recognizes revenue related to royalty, service, and other agreements in accordance with the five-step model in ASC 606. Sales-based royalties, for which the license is the predominant item to which the royalties relate, are recognized (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Service revenue is recognized at a point in time. the Company is not entitled to payment until the point at which the service is completed.
To recognize revenue for contracts that include a combination of products and services, we allocate the transaction price for the contract among the identified performance obligations on a relative standalone selling price basis. We establish standalone selling price basis for our products based on the observable price of the respective product. For services where the standalone selling price is not directly observable through historical transactions, we estimate standalone selling price using expected cost-plus margin based on management judgment by considering available data, such as labor cost of providing the services and internal margin objectives which include market and competitive conditions. Standalone selling prices for our products and services are reassessed periodically.
Recent Accounting Pronouncements
We are subject to recently issued accounting standards, accounting guidance and disclosure requirements. For a description of these new accounting standards, see Note 2, "Basis of Presentation and Liquidity," of the Notes to our Unaudited Interim Financial Statements contained in Item 1 of Part I of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.
Results of Operations
Fluctuations in Operating Results
Our results of operations have fluctuated significantly from period to period in the past, including recently, and are likely to continue to do so in the future. We anticipate that our annual results of operations will be impacted in the foreseeable future by several factors, including market acceptance of our products, expense management, and continued ability to achieve positive operating cash flow. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a good indication of our future performance.
Three Months Ended June 30, 2025 Compared to the Three Months Ended June 30, 2024
The following table sets forth our summarized, results of operations for the three months ended June 30, 2025 and 2024 (in thousands, except percentages):
| $ | % | |||||||||||||||
| Increase | Increase | |||||||||||||||
| 2025 | 2024 | (Decrease) | (Decrease) | |||||||||||||
| Total net revenues | $ | 4,419 | $ | 3,252 | $ | 1,167 | 36 | % | ||||||||
| Cost of goods sold | 1,624 | 1,340 | 284 | 21 | % | |||||||||||
| Gross margin | 2,795 | 1,912 | 883 | 46 | % | |||||||||||
| Gross margin % | 63 | % | 59 | % | - | 4 | % | |||||||||
| Selling, general and administrative expense | 2,201 | 1,941 | 260 | 13 | % | |||||||||||
| Research and development expense | 311 | 254 | 57 | 22 | % | |||||||||||
| Depreciation and amortization expense | 35 | 34 | 1 | 3 | % | |||||||||||
| Operating income (loss) | 248 | (317 | ) | 565 | 178 | % | ||||||||||
| Interest expense | (1 | ) | - | (1 | ) | 0 | % | |||||||||
| Interest income | 31 | 21 | 10 | 48 | % | |||||||||||
| Other income (expense), net | (32 | ) | 7 | (39 | ) | (557 | )% | |||||||||
| Income (loss) before income taxes | 246 | (289 | ) | 535 | 185 | % | ||||||||||
| Income tax expense | (9 | ) | - | (9 | ) | 0 | % | |||||||||
| Net income (loss) | $ | 237 | $ | (289 | ) | $ | 526 | 182 | % | |||||||
Revenue
Net revenue increased by $1.2 million, or 36%, in the second quarter of 2025 compared to the same period in 2024. This increase was primarily driven by increased revenue in both programmatic and emergency response. The growth in programmatic revenue reflects strong reorders, and a number of new active sites. The growth in emergency response sales reflects increased opportunities in 2025 compared to limited opportunities in the prior-year period.
Gross Profit Margin
Gross profit margin was approximately 63% for the three months ended June 30, 2025, compared to approximately 59% for the same period in 2024. The increase of approximately 4 percentage points was primarily driven by a reduction in shipping costs, and inventory reserve adjustments, both of which contributed to lower cost of goods sold.
Selling, General and Administrative Expenses
Selling, general and administrative expense increased by approximately $260,000, or 13%, for the three months ended June 30, 2025, compared to the same period in the prior year. The increase was primarily driven by higher sales commissions, higher accrual for employee bonuses, and increased stock-based compensation expense.
Research and Development Expenses
Research and development expenses increased approximately $57,000 due to higher salary expense, and higher accrual for employee bonuses.
Depreciation and Amortization Expense
Depreciation and amortization expenses were approximately $35,000 and $34,000, respectively, for the three months ended June 30, 2025, and 2024.
Interest Income
Interest income was approximately $31,000 for the three months ended June 30, 2025 compared to approximately $21,000 for the three months ended June 30, 2024.
Other Income (Expense), net
Other expense of approximately $32,000 for the three months ended June 30, 2025 is primarily a result of losses on foreign currency transactions. Other income of approximately $7,000 for the three months ended June 30, 2024, is primarily a result of a sale of a fully depreciated asset.
Six Months Ended June 30, 2025 Compared to the Six Months Ended June 30, 2024
The following table sets forth our summarized results of operations for the six months ended June 30, 2025 and 2024 (in thousands, except percentages):
| $ | % | |||||||||||||||
| Increase | Increase | |||||||||||||||
| 2025 | 2024 | (Decrease) | (Decrease) | |||||||||||||
| Total net revenues | $ | 9,296 | $ | 6,774 | $ | 2,522 | 37 | % | ||||||||
| Cost of goods sold | 3,347 | 2,675 | 672 | 25 | % | |||||||||||
| Gross margin | 5,949 | 4,099 | 1,850 | 45 | % | |||||||||||
| Gross margin % | 64 | % | 61 | % | - | 3 | % | |||||||||
| Selling, general and administrative expense | 4,455 | 4,083 | 372 | 9 | % | |||||||||||
| Research and development expense | 606 | 466 | 140 | 30 | % | |||||||||||
| Depreciation and amortization expense | 74 | 67 | 7 | 10 | % | |||||||||||
| Operating income (loss) | 814 | (517 | ) | 1,331 | 257 | % | ||||||||||
| Interest expense | (1 | ) | (1 | ) | - | - | % | |||||||||
| Interest income | 44 | 46 | (2 | ) | (4 | )% | ||||||||||
| Other income (expense), net | (53 | ) | 14 | (67 | ) | (479 | )% | |||||||||
| Income (loss) before income taxes | $ | 804 | $ | (458 | ) | $ | 1,262 | 276 | % | |||||||
| Income tax expense | (9 | ) | - | (9 | ) | - | % | |||||||||
| Net income (loss) | $ | 795 | $ | (458 | ) | $ | 1,253 | 274 | ||||||||
Revenue
Overall, net revenues increased by $2.5 million, or 37% for the six months ended June 30, 2025, compared to the same period in 2024. This increase was primarily driven by increased revenue in both programmatic and emergency response. The growth in programmatic revenue reflects strong reorders, and a number of new active sites. The growth in emergency response sales reflects more opportunities in the first half of 2025 compared to limited opportunities in the prior year period.
Gross Profit Margin
Gross margin was approximately 64% for the six months ended June 30, 2025, compared to approximately 61% for the same period in 2024. The increase of approximately 3 percentage points was primarily driven by lower product costs resulting from a more favorable product mix and a reduction in inventory reserve adjustments, both of which contributed to lower cost of goods sold.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased $372,000, or 9%, for the six months ended June 30, 2025, compared to the same period in the prior year. The increase was primarily driven by higher sales commission expense, increase employee bonus accruals, and higher stock-based compensation expense.
Research and Development Expenses
Research and development expenses increased $140,000 primarily due to an increase in headcount.
Depreciation and Amortization Expense
Depreciation and amortization expenses were approximately $74,000 and $67,000, respectively, for the six months ended June 30, 2025, and 2024.
Interest Income
Interest income was approximately $44,000 for the six months ended June 30, 2025 compared to approximately $46,000 for the six months ended June 30, 2024.
Other Income (Expense), net
Other expense was approximately $53,000 for the six months ended June 30, 2025, and is primarily a result of losses on foreign currency transactions. Other income was approximately $14,000 for the six months ended June 30, 2024, and is primarily a result of gains on foreign currency transactions and a sale of a fully depreciated asset.
Liquidity and Capital Resources
The following table summarizes our liquidity and capital resources as of June 30, 2025 and December 31, 2024 and is intended to supplement the more detailed discussion that follows. The amounts stated are expressed in thousands.
| June 30, | December 31, | |||||||
| Liquidity and Capital Resources | 2025 | 2024 | ||||||
| Cash and cash equivalents | $ | 5,074 | $ | 3,760 | ||||
| Other current assets | 4,504 | 4,538 | ||||||
| Working capital | 7,806 | 6,736 | ||||||
| Stockholders' equity | 9,599 | 8,585 | ||||||
As of June 30, 2025, we had an accumulated deficit of $143.5 million. Although we were profitable in the quarter ended June 30, 2025, the six months ended June 30, 2025, and the full year ended December 31, 2024, we may incur future operating losses if we are unable to maintain or increase our revenue.
Based on cash that is available for our operations and projections of our future operations, we believe that our cash balances will be sufficient to fund our current operating plan through at least the next 12 months from the date of issuance of the financial statements in this Quarterly Report on Form 10-Q. Additionally, our operating plans are designed to help control operating costs and to increase revenue so we can continue to generate sufficient cash flows to fund operations. If there were a decrease in the demand for our products due to either economic or competitive conditions, or if we are otherwise unable to achieve our plan or achieve our anticipated operating results, there could be a significant reduction in liquidity due to our possible inability to cut costs sufficiently. In such event, the Company may need to take further actions to reduce its discretionary expenditures, including further reducing headcount, reducing spending on R&D projects, and reducing other variable costs.
Our future liquidity sources and requirements will depend on many other factors, including:
| ● | the market acceptance of our products, and our ability to effectively and efficiently produce, market and sell our products; | |
| ● | the costs involved in filing and enforcing patent claims and the status of competitive products; and | |
| ● | the cost of litigation, including potential patent litigation and any other actual or threatened litigation. |
We expect to put our current capital resources toward the development, marketing, and sales of our water filtration products and working capital purposes.
Net cash provided by operating activities was $1.3 million for the six months ended June 30, 2025, compared to net cash used by operating activities of approximately $1.2 million for the six months ended June 30, 2024. Net cash provided by operating activities in 2025 was primarily due to the net income of approximately $0.8 million, a decrease in inventory of approximately $0.3 million, offset by an increase in accounts receivable of approximately $0.3 million. Net cash used in operating activities in 2024 was primarily due to the net loss of approximately $0.5 million, an increase in inventory of approximately $0.5 million, an increase in accounts receivable of approximately $0.4 million and a decrease in accrued expenses of approximately $0.4 million, offset by an increase in accounts payable of approximately $0.3 million, and an increase in inventory impairments and write offs of approximately $0.2 million.
We had no investing activities for the six months ended June 30, 2025. Net cash used in investing activities was approximately $50,000 in the six months ended June 30, 2024, due to purchases of property and equipment.
Net cash used in financing activities was approximately $2,000 and $4,000 for the six months ended June 30, 2025 and June 30, 2024, respectively, primarily due to payments on finance lease
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of June 30, 2025.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain statements in this Quarterly Report on Form 10-Q constitute "forward-looking statements." Such statements include statements regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing such products to market, the timeline for regulatory review and approval of our products, the availability of funding sources for continued development of such products, and other statements that are not historical facts, including statements which may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guaranties of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include, but are not limited to, the risks that:
| ● | we face significant challenges in obtaining market acceptance of our products, which, if not obtained, could adversely affect our potential sales and revenues; | |
| ● | product-related deaths or serious injuries or product malfunctions could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products; | |
| ● | we face potential liability associated with the production, marketing and sale of our products, and the expense of defending against claims of product liability could materially deplete our assets and generate negative publicity, which could impair our reputation; |
| ● | to the extent our products or marketing materials are found to violate any provisions of the U.S. Food, Drug and Cosmetic Act (the "FDC Act") or any other statutes or regulations, we could be subject to enforcement actions by the U.S. Food and Drug Administration (the "FDA") or other governmental agencies; | |
| ● | we may not be able to obtain funding when needed or on terms favorable to us in order to continue operation; | |
| ● | we may not have sufficient capital to successfully implement our business plan; | |
| ● | we may not be able to effectively market our products; | |
| ● | we may not be able to sell our water filtration products at competitive prices or profitably; |
| ● | we may encounter problems with our suppliers, manufacturers, and distributors; | |
| ● | we may experience increased costs and/or disruptions in our supply chain due to the imposition of U.S. tariffs; | |
| ● | we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures; | |
| ● | we may not be able to obtain appropriate or necessary regulatory approvals to achieve our business plan; | |
| ● | we may not be able to secure or enforce adequate legal protection, including patent protection, for our products; and | |
| ● | we may not be able to achieve sales growth in key geographic markets. |
More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Quarterly Report on Form 10-Q, is set forth in our filings with the U.S. Securities and Exchange Commission (the "SEC"), including our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our Quarterly Report on Form 10-Q for the period ended March 31, 2025 and our other reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC's web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.