NEPHROS INC
For the period ended Dec 31, 2023. Filed Mar 15, 2024.
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FY2023 · Filed Mar 15, 2024
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Item 8. Financial Statements and Supplementary Data
To the Board of Directors and Stockholders of
Nephros, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Nephros, Inc. (the “Company”) as of December 31, 2023 and 2022, and the related statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Inventory Valuation
Critical Audit Matter Description
As described in Note 2 to the financial statements, inventory consists of finished goods and raw materials and is valued at the lower of cost or net realizable value using the first-in, first-out method. The Company’s inventory reserve requirements are based on various factors including product expiration date and estimates for the future sales of the product. Reserve assessments include inventory obsolescence based upon expiration date, damaged or rejected product, slow-moving products, and other considerations.
We identified the assessment of the excess and obsolete inventory reserve as a critical audit matter. The principal consideration for our determination that this is a critical audit matter is the significant judgment by management to estimate the excess and obsolete inventory reserve, which led to a high degree of auditor judgment, subjectivity and effort in performing procedures to evaluate management’s significant assumptions.
How We Addressed the Matter in Our Audit
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial statements. The primary procedures we performed to address this critical audit matter included:
| ● | testing management’s process for estimating the excess and obsolete inventory reserve, including evaluating the appropriateness of the approach utilized and underlying assumptions |
| ● | testing the mathematical accuracy of the excess and obsolete inventory reserve calculation |
| ● | testing the completeness and accuracy of underlying data used in the analysis, including historical usage and inventory age |
/s/ Baker Tilly US, LLP
We have served as the Company’s auditor since 2015.
Tewksbury, Massachusetts
March 15, 2024
(In thousands, except share and per share amounts)
| December 31, 2023 · December 31, 2022 | |||
|---|---|---|---|
| ASSETS | |||
| Current assets: | |||
| Cash and cash equivalents | $4,307 | $3,634 | |
| Accounts receivable, net | 1,496 | 1,286 | |
| Inventory | 2,470 | 3,153 | |
| Prepaid expenses and other current assets | 132 | 188 | |
| Total current assets | 8,405 | 8,261 | |
| Property and equipment, net | 152 | 116 | |
| Lease right-of-use assets | 1,807 | 984 | |
| Intangible assets, net | 381 | 423 | |
| Goodwill | 759 | 759 | |
| License and supply agreement, net | 271 | 402 | |
| Other assets | 86 | 54 | |
| TOTAL ASSETS | $11,861 | $10,999 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||
| Current liabilities: | |||
| Current portion of secured note payable | $ | - | $71 |
| Accounts payable | 873 | 740 | |
| Accrued expenses | 794 | 285 | |
| Current portion of lease liabilities | 446 | 316 | |
| Total current liabilities | 2,113 | 1,412 | |
| Equipment financing, net of current portion | - | 1 | |
| Lease liabilities, net of current portion | 1,390 | 705 | |
| TOTAL LIABILITIES | 3,503 | 2,118 | |
| COMMITMENTS AND CONTINGENCIES (Note 17) | - | - | |
| STOCKHOLDERS’ EQUITY: | |||
| Preferred stock, $.001 par value; 5,000,000 shares authorized at December 31, 2023 and 2022; no shares issued and outstanding at December 31, 2023 and 2022 | - | - | |
| Common stock, $.001 par value; 40,000,000 shares authorized at December 31, 2023 and 2022; 10,543,675 and 10,297,429 shares issued and outstanding at December 31, 2023 and 2022, respectively | 10 | 10 | |
| Additional paid-in capital | 152,754 | 148,413 | |
| Accumulated deficit | (144,406) | (142,831) | |
| Subtotal | 8,358 | 5,592 | |
| Noncontrolling interest | - | 3,289 | |
| TOTAL STOCKHOLDERS’ EQUITY | 8,358 | 8,881 | |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $11,861 | $10,999 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
| Years Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Net revenue: | ||
| Product revenues | $14,110 | $9,929 |
| Royalty and other revenues | 128 | 46 |
| Total net revenues | 14,238 | 9,975 |
| Cost of goods sold | 5,833 | 5,244 |
| Gross Margin | 8,405 | 4,731 |
| Operating expenses: | ||
| Research and development | 873 | 1,255 |
| Depreciation and amortization | 214 | 218 |
| Selling, general and administrative | 8,911 | 7,593 |
| Total operating expenses | 9,998 | 9,066 |
| Operating loss from continuing operations | (1,593) | (4,335) |
| Other (expense) income: | ||
| Interest expense | (2) | (20) |
| Interest income | 64 | 14 |
| Other (expense) income, net | (44) | 64 |
| Total other income: | 18 | 58 |
| Loss from continuing operations | (1,575) | (4,277) |
| Net loss from discontinued operations | - | (2,829) |
| Net loss | (1,575) | (7,106) |
| Less: undeclared deemed dividend attributable to noncontrolling interest | - | (276) |
| Net loss attributable to Nephros, Inc. shareholders | (1,575) | (7,382) |
| Net loss per common share, basic and diluted from continuing operations | $(0.15) | $(0.42) |
| Net loss per common share, basic and diluted from discontinued operations | - | (0.28) |
| Net loss per common share, basic and diluted | $(0.15) | $(0.70) |
| Net loss per common share, basic and diluted, attributable to continuing noncontrolling interest | - | (0.03) |
| Net loss per common share, basic and diluted, attributable to Nephros, Inc, shareholders | $(0.15) | $(0.73) |
| Weighted average common shares outstanding, basic and diluted | 10,386,018 | 10,297,134 |
| Comprehensive loss: | ||
| Net loss | $(1,575) | $(7,106) |
| Other comprehensive loss, foreign currency translation adjustments, net of tax | - | (14) |
| Comprehensive loss | (1,575) | (7,120) |
| Comprehensive loss attributable to continuing noncontrolling interest | - | (276) |
| Comprehensive loss attributable to Nephros, Inc. shareholders | $(1,575) | $(7,396) |
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(In thousands, except share amounts)
| Common Stock · Additional Paid-in · Accumulated Other Comprehensive · Accumulated · Noncontrolling · Total Stockholders’ | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Shares · Amount · Capital · Income · Deficit · Subtotal · Interest · Equity | ||||||||||
| Balance, December 31, 2021 | 10,198,712 | $10 | $147,346 | $64 | $(135,725) | $11,695 | $3,054 | $14,749 | ||
| Net loss | - | - | - | - | (7,106) | (7,106) | (7,106) | |||
| Change in non-controlling interest | 188 | 188 | ||||||||
| Restricted stock vesting | 44,732 | - | - | - | - | - | - | |||
| Elimination of cumulative translation adjustment, upon closing of wholly owned foreign subsidiary | - | - | (64) | - | (64) | - | (64) | |||
| Exercise of warrants | 60,374 | - | 163 | - | - | 163 | - | 163 | ||
| Restricted shares withheld for employee taxes | (6,389) | - | (31) | - | - | (31) | - | (31) | ||
| Stock-based compensation | - | - | 935 | - | - | 935 | 47 | 982 | ||
| Balance, December 31, 2022 | 10,297,429 | $10 | $148,413 | $ | - | $(142,831) | $5,592 | $3,289 | $8,881 | |
| Net loss | - | - | - | - | (1,575) | (1,575) | - | (1,575) | ||
| Change in non-controlling interest | - | - | 3,262 | - | - | 3,262 | (3,262) | - | ||
| Cashless exercise of stock options | 16,576 | - | - | - | ||||||
| Restricted stock vesting | 187,503 | - | - | - | - | - | - | - | ||
| Stock-based compensation | - | - | 1,079 | - | - | 1,079 | (27) | 1,052 | ||
| Balance, December 31, 2023 | 10,501,508 | $10 | $152,754 | $ | - | $(144,406) | $8,358 | $ | - | $8,358 |
(In thousands)
| Years Ended December 31, | ||||
|---|---|---|---|---|
| 2023 · 2022 | ||||
| OPERATING ACTIVITIES: | ||||
| Net loss | $(1,575) | $(7,106) | ||
| Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||||
| Depreciation of property and equipment | 39 | 93 | ||
| Amortization of intangible assets, license and supply agreement and finance lease right-of-use asset | 175 | 258 | ||
| Stock-based compensation | 1,052 | 982 | ||
| Inventory impairments and writeoffs | 295 | 773 | ||
| Increase (Decrease) in provision for bad debt | 11 | (1) | ||
| Impairment of assets held for sale | - | 1,395 | ||
| Gain (Loss) on foreign currency transactions | - | (60) | ||
| Decrease (Increase) in operating assets: | ||||
| Accounts receivable | (221) | 357 | ||
| Inventory | 387 | 765 | ||
| Prepaid expenses and other current assets | 56 | 26 | ||
| Change in right-of-use asset | (342) | 353 | ||
| Other assets | (31) | 29 | ||
| (Decrease) Increase in operating liabilities: | ||||
| Accounts payable | 133 | (593) | ||
| Accrued expenses | 506 | (150) | ||
| Lease liabilities | 342 | (355) | ||
| Net cash provided by (used in) operating activities | 827 | (3,234) | ||
| INVESTING ACTIVITIES: | ||||
| Purchase of property and equipment | (75) | (137) | ||
| Net cash used in investing activities | (75) | (137) | ||
| FINANCING ACTIVITIES: | ||||
| Proceeds from sale of subsidiary preferred shares to noncontrolling interest | - | 188 | ||
| Payments on secured note payable | (71) | (271) | ||
| Principal payments on finance lease liability | (7) | (12) | ||
| Principal payments on equipment financing | (1) | (3) | ||
| Payments to employee taxes on restricted stock | - | (31) | ||
| Proceeds from exercise of warrants | - | 163 | ||
| Net cash provided by (used in) financing activities | (79) | 34 | ||
| Effect of exchange rates on | - | (2) | ||
| Net increase (decrease) in cash and cash equivalents | 673 | (3,339) | ||
| Cash and cash equivalents, beginning of year | 3,634 | 6,973 | ||
| Cash and cash equivalents, end of year | $4,307 | $3,634 | ||
| Supplemental disclosure of cash flow information | ||||
| Cash paid for interest expense | $2 | $19 | ||
| Cash paid for income taxes | $ | - | $ | - |
| Supplemental disclosure of noncash investing and financing activities | ||||
| Right-of-use asset obtained in exchange for operating lease liability | $1,164 | $743 | ||
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1 -Organization and Nature of Operations
Nephros, Inc. (“Nephros” or the “Company”) was incorporated under the laws of the State of Delaware on April 3, 1997. The Company was founded by health professionals, scientists and engineers affiliated with Columbia University to develop advanced end stage renal disease (“ESRD”) therapy technology and products.
Beginning in 2009, Nephros introduced high performance liquid purification filters to meet the demand for water purification in certain medical markets. The Company’s filters, generally classified as ultrafilters, are primarily used in hospitals for the prevention of infection from waterborne pathogens, such as legionella and pseudomonas, and in dialysis centers for the removal of biological contaminants from water and bicarbonate concentrate. The Company also develops and sells water filtration products for commercial applications, focusing on the hospitality and food service markets. The water filtration business is a reportable segment, referred to as the Water Filtration segment.
On October 4, 2022, the Company entered into a definitive asset purchase agreement with a third party for the sale of substantially all of the Company’s Pathogen Detection Systems (“PDS”) business, which had been previously reported as a separate reportable operating segment. As a result of the sale of the PDS business, we completely exited the PDS business. As a result, we determined that our PDS business had met the criteria for discontinued operations as of September 30, 2022. We no longer separately report the PDS business as a separate reportable segment in our financial statements including in this Annual Report for any of the periods presented.
In July 2018, the Company formed a subsidiary, Specialty Renal Products, Inc. (“SRP”), to drive the development of its second-generation hemodiafiltration system and other products focused on improving therapies for patients with renal disease. After SRP’s formation, the Company assigned to SRP all of the Company’s rights to three patents relating to the Company’s hemodiafiltration technology, which were carried at zero book value. On March 9, 2023, the SRP Stockholders approved a plan of dissolution to wind down SRP’s operations, liquidate SRP’s remaining assets and dissolve SRP. Pursuant to such plan, SRP filed a certificate of dissolution with the State of Delaware on April 13, 2023. As a result of the SRP Stockholders’ approval of the plan of dissolution and provisions therein and after satisfying all of SRP’s liabilities, there are no assets available for distribution to the holders of any of SRP’s capital stock, including its Series A Preferred Stock. As such, the value recorded to non-controlling interest was written to zero and the impact reclassified to the Company’s additional paid-in capital as the Company retained control of SRP.
The Company’s primary U.S. facility is located at 380 Lackawanna Place, South Orange, New Jersey 07079. This location along with our Whippany, NJ facility, houses the Company’s corporate headquarters, research, manufacturing, and distribution facilities.
Note 2 -Summary of Significant Accounting Policies
Principles of Consolidation and Basis of Presentation
The accompanying consolidated financial statements include the accounts of Nephros, Inc. and its subsidiaries, including the Company’s wholly owned subsidiary Nephros International, which was dissolved during the quarter ended June 30, 2022, and SRP, which was dissolved pursuant to a plan of dissolution adopted by its stockholders on March 9, 2023 and the subsequent filing of a certificate of dissolution with the State of Delaware on April 13, 2023. All intercompany accounts and transactions were eliminated in the preparation of the accompanying consolidated financial statements.
Discontinued Operations
See Note 3, Discontinued Operations, for a discussion of the Company’s significant accounting policy surrounding the sale of substantially all of the Company’s PDS business.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amount of revenues and expenses, during the reporting period. Actual results could differ materially from those estimates. Included in these estimates are assumptions about the collection of accounts receivable, value of inventories, useful life of fixed assets and intangible assets, the assessment of expected cash flows used in evaluating goodwill and other long-lived assets, the assessment of the ability to continue as a going concern and assumptions used in determining stock compensation such as expected volatility and risk-free interest rate.
Reclassifications
Certain reclassifications were made to the prior year’s amounts to conform to the 2023 presentation. On the Consolidated Statements of Cash Flows, Inventory impairments and writeoffs reported as $623,000 for the year ended December 31, 2022, was increased to $773,000, and Inventory reported as $915,000 for the year ended December 31, 2022 was decreased to $765,000, to accurately reflect the non-cash portion of the change in inventories for the year ended December 31, 2022.
Liquidity
In February 2022, pursuant to a First Amendment to Series A Preferred Stock Purchase Agreement (the “Amendment”) among SRP and the holders of SRP’s outstanding shares of Series A Preferred Stock, SRP issued and sold an additional 100,003 shares of its Series A Preferred Stock at a price of $5.00 per share, resulting in total gross proceeds of $500,015. See “Note 15 – Stockholders’ Equity – Noncontrolling Interest,” below. In addition to the funds provided by the sale of these additional shares of Series A Preferred Stock, the Company and SRP also maintained a loan agreement under which the Company loaned $1.3 million to SRP, of which $1.0 million had been loaned during the year ended December 31, 2020. These loaned funds were used to fund SRP’s operating activities through the FDA 510(k) clearance process of SRP’s second-generation hemodiafiltration system, which was initially submitted to the FDA on February 24, 2021, and which received 510(k) clearance on May 13, 2022. In connection with SRP’s plan of dissolution and pursuant to an agreement between the Company and SRP entered into on May 24, 2023, SRP assigned substantially all of its remaining assets to the Company in satisfaction of the entire loan balance. Accordingly, as of December 31, 2023, there wasno outstanding balance of this loan.
The Company has sustained operating losses every quarter through December 31, 2023, generating an accumulated deficit of $144.4 million as of December 31, 2023. Throughout 2023, however, the Company’s operating cash flows have been positive due to increased sales, improved gross margins, careful expense management, and the dispositions of the PDS and SRP businesses. These actions resulted in the Company generating cash from operations of approximately $0.8 million through the twelve months ended December 31, 2023. Based on these positive cash flows, the Company believes that its cash balances are sufficient to fund its current operating plan through at least the next 12 months from the date of issuance of the accompanying consolidated financial statements. However, in the event that the Company’s operating results do not meet its expectations, the Company may need to further reduce discretionary expenditures such as headcount, R&D projects, and other variable costs.
Concentration of Credit Risk
The Company deposits its cash in financial institutions. At times, such deposits may be in excess of insured limits. To date, the Company has not experienced any impairment losses on its cash. The Company also limits its credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary.
Major Customers
For the years ended December 31, 2023 and 2022, the following customers accounted for the following percentages of our revenues, respectively:
| Customer | 2023 | 2022 |
|---|---|---|
| A | 23% | 26% |
| B | 11% | 10% |
| Total | 34% | 36% |
As of December 31, 2023 and 2022, the following customers accounted for the following percentages of our accounts receivable, respectively:
| Customer | 2023 | 2022 |
|---|---|---|
| A | 12% | 21% |
| B | 6% | 10% |
| C | 3% | 10% |
| Total | 21% | 41% |
Cash and Cash Equivalents
The Company considers all highly liquid money market instruments with an original maturity of three months or less when purchased to be cash equivalents. The company also classifies, as cash equivalents, certificates of deposit with an original maturity of greater than three months for which there is no cost to withdrawal funds prior to maturity date. At December 31, 2023 and 2022, cash and cash equivalents were deposited in financial institutions and consisted entirely of immediately available fund balances. The Company maintains its cash deposits and cash equivalents with financial institutions it believes to be well-known and stable.
Accounts Receivable
The Company recognizes an allowance that reflects a current estimate of credit losses expected to be incurred over the life of a financial asset, including trade receivables. The Company continuously monitors collections and payments from its customers and maintains a provision for estimated credit losses. The Company determines its allowance for credit losses by considering a number of factors, including the length of time balances are past due, the Company’s previous loss history, the customer’s current ability to pay its obligations to the Company and the expected condition of the general economy and the industry as a whole. The Company writes off accounts receivable when they are determined to be uncollectible. The allowance for doubtful accounts was approximately $11,000 and $0 as of December 31, 2023 and 2022, respectively.
Inventory
For all medical device products and some commercial products, the Company engages third parties to manufacture and package its finished goods, which are shipped to the Company for warehousing, until sold to distributors or end customers. Some commercial products are manufactured at Company facilities. Inventory consists of finished goods and raw materials and is valued at the lower of cost or net realizable value using the first-in, first-out method.
Our inventory reserve requirements are based on various factors including product expiration date and estimates for the future sales of the product. Reserve assessments include inventory obsolescence based upon expiration date, damaged, or rejected product, slow-moving products, and other considerations.
License and Supply Rights
The Company’s rights under the License and Supply Agreement with Medica are capitalized and stated at cost, less accumulated amortization, and are amortized using the straight-line method over the term of the License and Supply Agreement, which is from April 23, 2012 through December 31, 2028. The Company determines amortization periods for licenses based on its assessment of various factors impacting estimated useful lives and cash flows of the acquired rights. Such factors include the expected launch date of the product, the strength of the intellectual property protection of the product and various other competitive, developmental, and regulatory issues, and contractual terms. See Note 9 – License and Supply Agreement, net for further discussion.
Leases
The Company determines if an arrangement contains a lease at inception. Leases are included in lease right-of-use (“ROU”) assets and lease liabilities on the consolidated balance sheet.
Lease ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset includes any lease payments made and initial direct costs incurred and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
The Company has elected as an accounting policy not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term.
The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component.
Property and Equipment, net
Property and equipment, net is stated at cost less accumulated depreciation. These assets are depreciated over their estimated useful lives ofthree toseven years using the straight-line method.
The Company adheres to ASC 360 and periodically evaluates whether current facts or circumstances indicate that the carrying value of its depreciable assets to be held and used may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived assets, or the appropriate grouping of assets, is compared to the carrying value to determine whether impairment exists. If an asset is determined to be impaired, the loss is measured based on the difference between the asset’s fair value and its carrying value. For long-lived assets, the estimate of fair value is based on various valuation techniques, including a discounted value of estimated future cash flows. The Company reports an asset to be disposed of at the lower of its carrying value or its fair value less costs to sell. For the year ended December 31, 2022, See Note 3 Discontinued Operations, for a discussion of the Company’s significant accounting policy surrounding the sale of substantially all of the Company’s PDS business and related impairment charge. There wereno impairment losses for long-lived assets recorded for the year ended December 31, 2023.
Intangible Assets
The Company’s intangible assets include finite lived assets. Finite lived intangible assets, consisting of customer relationships, tradenames, service marks and domain names are amortized on a straight-line basis over the estimated useful lives of the assets.
Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Impairment testing requires management to estimate the future undiscounted cash flows of an intangible asset using assumptions believed to be reasonable, but which are unpredictable and inherently uncertain. Actual future cash flows may differ from the estimates used in the impairment testing.
Goodwill
Goodwill represents the excess of purchase price over the fair value of net assets acquired. In accordance with ASC 350, “Goodwill and Other Intangibles,” rather than recording periodic amortization, goodwill is subject to an annual assessment for impairment by applying a fair value-based test. If the fair value of the reporting unit exceeds the reporting unit’s carrying value, including goodwill, then goodwill is considered not impaired, making further analysis not required. The Company reviews goodwill for possible impairment annually during the fourth quarter, or whenever events or circumstances indicate that the carrying amount may not be recoverable.
Fair Value Measurements
The Company measures certain financial instruments and other items at fair value.
To determine the fair value, the Company uses the fair value hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs based on assumptions about the factors market participants would use to value an asset or liability.
To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
*Level 2 -*Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and also includes instruments for which the determination of fair value requires significant judgment or estimation.
Revenue Recognition
The Company recognizes revenue under ASC 606, “Revenue from Contracts with Customers.” ASC 606 prescribes a five-step model for recognizing revenue, which includes (i) identifying contracts with customers; (ii) identifying performance obligations; (iii) determining the transaction price; (iv) allocating the transaction price; and (v) recognizing revenue. See Note 4 – Revenue Recognition for further discussion.
Shipping and Handling Costs
Shipping and handling costs charged to customers are recorded as revenue and as cost of goods sold and were approximately $107,000 and $98,000 for the years ended December 31, 2023 and 2022, respectively.
Research and Development Costs
Research and development costs represent a significant part of our business. Costs included in research and development are expensed as incurred and relate to the processes of discovering, testing and developing new products, improving existing products and regulatory compliance prior to FDA approval. Research and development costs include, but are not limited to, personnel expenses, consulting costs and equipment depreciation.
Stock-Based Compensation
The fair value of stock options is recognized as stock-based compensation expense in the Company’s consolidated statement of operations and comprehensive loss. The Company calculates stock-based compensation expense in accordance with ASC 718. The fair value of the Company’s stock option awards is estimated using a Black-Scholes option valuation model. This model requires the input of highly subjective assumptions and elections including expected stock price volatility and the estimated life of each award. The fair value of stock-based awards is amortized over the vesting period of the award. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the condition will be met.
Warrants
The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement.
Other Income and Expense, net
Other expense of approximately $44,000 for the year ended December 31, 2023, is primarilya result of losses on foreign currency transactions. Other income of approximately $64,000 for the year ended December 31, 2022, isprimarily related to the release of the cumulative translation adjustment from accumulated other comprehensive income (loss) on the liquidation of a foreign entity andof gains on foreign currency transactions related to the closure in the second quarter of 2022 of Nephros International, a wholly owned subsidiary of Nephros, Inc.
Income Taxes
The Company accounts for income taxes in accordance with ASC 740, which requires accounting for deferred income taxes under the asset and liability method. Deferred income taxes are recognized for the tax consequences of temporary differences by applying enacted statutory tax rates applicable in future years to differences between the financial statement carrying amounts and the tax basis of existing assets and liabilities.
For financial reporting purposes, the Company has incurred a loss in each period since its inception. Based on available objective evidence, including the Company’s history of losses, management believes it is more likely than not that the net deferred tax assets will not be fully realizable. Accordingly, the Company provided for a full valuation allowance against its net deferred tax assets at December 31, 2023 and 2022.
ASC 740 prescribes, among other things, a recognition threshold and measurement attributes for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in a company’s income tax return. ASC 740 utilizes a two-step approach for evaluating uncertain tax positions. Step one, or recognition, requires a company to determine if the weight of available evidence indicates a tax position is more likely than not to be sustained upon audit, including resolution of related appeals or litigation processes, if any. Step two, or measurement, is based on the largest amount of benefit that is more likely than not to be realized on settlement with the taxing authority. The Company is subject to income tax examinations by major taxing authorities for all tax years subsequent to 2016. During the years ended December 31, 2023 and 2022, the Company recognized no adjustments for uncertain tax positions. However, management’s conclusions regarding this policy may be subject to review and adjustment at a later date based on factors including, but not limited to, on-going analyses of and changes to tax laws, regulation and interpretations, thereof.
See Note 13 – Income Taxes for further discussion.
Net Loss per Common Share
Basic loss per common share is calculated by dividing net loss available to common shareholders by the number of weighted average common shares issued and outstanding. Diluted loss per common share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares issued and outstanding for the period, plus amounts representing the dilutive effect from the exercise of stock options and warrants and unvested restricted stock, as applicable. The Company calculates dilutive potential common shares using the treasury stock method, which assumes the Company will use the proceeds from the exercise of stock options and warrants to repurchase shares of common stock to hold in its treasury stock reserves.
The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be antidilutive:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Shares underlying options outstanding | 1,789,206 | 1,365,365 |
| Unvested restricted stock | 42,167 | - |
Foreign Currency Translation
Foreign currency translation is recognized in accordance with ASC 830. The functional currency of Nephros International Limited, the Company’s Irish subsidiary is the Euro, and its translation gains and losses are included in accumulated other comprehensive income. The balance sheet is translated at the year-end rate. The consolidated statements of operations and comprehensive loss are translated at the weighted average rate for the year.
Transactions denominated in a currency other than an entity’s functional currency may give rise to transaction gains and losses. The Company recognizes transaction gains and losses within other (expense) income, net, within the consolidated statements of operations and comprehensive loss.
Comprehensive Loss
Comprehensive loss, as defined in ASC 220, is the total of net loss and all other non-owner changes in equity (or other comprehensive loss). The Company’s other comprehensive loss consists only of foreign currency translation adjustments.
Segment Reporting
The Company operates in only one business segment from which the Company’s chief operating decision maker evaluates the financial performance of the Company.
Recent Accounting Pronouncements, Not Yet Effective
In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures,” which enhances the transparency and decision usefulness of income tax disclosures. The guidance is effective for the Company’s annual reporting period ending December 31, 2025. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, “Improvements to Reportable Segment Disclosures,” which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The guidance is effective for the Company beginning in the annual reporting period ending December 31, 2024 and interim periods beginning in fiscal year 2025. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.
Note 3 –Discontinued Operations
In accordance with ASC 205-20, Presentation of Financial Statements: Discontinued Operations, a disposal of a component of an entity or a group of components of an entity (disposal group) is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results when the disposal group meets the criteria to be classified as held-for-sale. The consolidated statements of operations reported for current and prior periods report the results of operations of the discontinued operations, including the impairment loss recognized as a component of net income (loss) separate from the net income (loss) from continuing operations.
All discontinued operations relate to the Company’s previously reported PDS segment, for the year ended December 31, 2022.
| (In thousands) | Year Ended December 31, |
|---|---|
| Total net revenues | $110 |
| Gross margin | (259) |
| Research and development expenses | 637 |
| Depreciation and amortization expense | - |
| Selling, general and administrative expenses | 535 |
| Total operating expenses | 1,175 |
| Operating loss from discontinued operations | (1,434) |
| Impairment of assets held for sale | (1,395) |
| Loss from discontinued operations | $(2,829) |
On October 4, 2022, the Company entered into a definitive asset purchase agreement with a third party pursuant to which the Company agreed to sell substantially all of the assets used in the Company’s PDS business. In consideration for the sale of these assets, the Company received $1,000 in cash at the closing, and will receive potential royalties payable to Nephros for aseven-year period commencing on January 1, 2023 subject to a minimum gross margin threshold. As such, the potential royalties payable to the Company are a gain contingency as they pertain to an uncertain event that will be resolved in future reporting periods. As a result, the Company will recognize the gain contingency when it is probable the contingency will be resolved, which is ultimately when settled. The Company determined all of the required criteria for held-for-sale and discontinued operations classification were met as of September 30, 2022. Additionally, the Company evaluated the disposal group including the relevant intangible assets and recorded an impairment loss of $1,395,000. Based upon the selling price less the costs of sale, the Company determined the net carrying value of the assets held for sale were impaired, and the value of the asset group to be sold was $0.
The following items related to discontinued operations were included in the consolidated statement of cash flows:
| (in thousands) | For the Year ended December 31, 2022 |
|---|---|
| Depreciation | $42 |
| Amortization | 82 |
| Stock compensation | 38 |
| Impairment of assets held-for-sale | 1,395 |
| Operating lease right-of-use assets | 33 |
| Purchases of property and equipment | (34) |
During year ended December 31, 2022, $49,000 of right-of-use assets related to discontinuing operations were obtained in exchange for operating lease liabilities.
Note 4 –Revenue Recognition
The Company recognizes revenue related to product sales when product is shipped via external logistics providers and the other criteria of ASC 606 are met. Product revenue is recorded net of returns and allowances. There was no allowance for sales returns at December 31, 2023 or 2022. In addition to product revenue, the Company recognizes revenue related to royalty and other agreements in accordance with the five-step model in ASC 606. Royalty and other revenues recognized for the years ended December 31, 2023 and 2022 (in thousands) is comprised of:
| Years Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Other revenue | $97 | $46 |
| Royalty revenue under the Sublicense Agreement with CamelBak (1) | 31 | - |
| Total royalty and other revenues | $128 | $46 |
| (1) | In May 2015, the Company entered into a Sublicense Agreement (the “Sublicense Agreement”) with CamelBak Products, LLC (“CamelBak”). Under this Sublicense Agreement, the Company granted CamelBak an exclusive, non-transferable, worldwide (with the exception of Italy) sublicense and license, in each case solely to market, sell, distribute, import and export the IWTD. In exchange for the rights granted to CamelBak, CamelBak agreed, through December 31, 2022, to pay the Company a percentage of the gross profit on any sales made to a branch of the U.S. military, subject to certain exceptions, and to pay a fixed per-unit fee for any other sales made. CamelBak was also required to meet or exceed certain minimum annual fees payable to the Company, and, if such fees are not met or exceeded, the Company was able to convert the exclusive sublicense to a non-exclusive sublicense with respect to non-U.S. military sales. In the first quarter of 2019, the Sublicense Agreement was amended to eliminate the minimum fee obligations starting May 6, 2018 and, as such, CamelBak has no further minimum fee obligations. The Sublicense Agreement expired on December 31, 2022, though we and CamelBak thereafter orally agreed to continue operating under the terms of the Sublicense agreement. In March 2024, we entered into a further written amendment to the Sublicense Agreement, which was made effective December 31, 2022, that extended the term of the Sublicense Agreement through December 31, 2025. |
Other Revenue – Other revenues are derived from sales of services to customers, which primarily include installation, training and testing on product and equipment sold to certain customers.
Note 5 –Fair Value Measurements
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification for each reporting period.
At December 31, 2023 and December 31, 2022, the Company’s cash equivalents consisted of money market funds. The Company values its cash equivalents using observable inputs that reflect quoted prices for securities with identical characteristics and classify the valuation techniques that use these inputs as Level 1.
At December 31, 2023 and December 31, 2022, the fair value measurements of the Company’s assets and liabilities measured on a recurring basis were as follows:
| Fair Value Measurements at Reporting Date Using | |||||
|---|---|---|---|---|---|
| Quoted Prices in Active Markets for Identical Assets (Level 1) · Significant Other Observable Inputs (Level 2) · Significant Unobservable Inputs (Level 3) | |||||
| (in thousands) | |||||
| Cash | $274 | $ | - | $ | - |
| Money market funds | 2,515 | - | - | ||
| Certificate of deposit | 1,518 | ||||
| Cash and cash equivalents | $4,307 | $ | - | $ | - |
| Cash | $1,598 | - | - | ||
| Money market funds | 2,036 | - | - | ||
| Cash and cash equivalents | $3,634 | $ | - | $ | - |
Assets and Liabilities Not Measured at Fair Value on a Recurring Basis
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value as of December 31, 2023 and 2022 due to the short-term maturity of these instruments.
The carrying amounts of the secured long-term note payable, lease liabilities and equipment financing approximate fair value as of December 31, 2023 and 2022 because those financial instruments bear interest at rates that approximate current market rates for similar agreements with similar maturities and credit.
Note 6 -Inventory
Inventory is stated at the lower of cost or net realizable value using the first-in, first-out method and consists of raw materials and finished goods. The Company’s inventory components as of December 31, 2023 and December 31, 2022, were as follows:
| (In thousands) | December 31, | |
|---|---|---|
| 2023 | 2022 | |
| Finished goods | $2,144 | $2,709 |
| Raw material | 326 | 422 |
| Work in process | - | 22 |
| Total inventory | $2,470 | $3,153 |
Note 7 -Property and Equipment, Net
Property and equipment as of December 31, 2023 and 2022 was as follows (in thousands):
| Estimated Useful · December 31, | |||
|---|---|---|---|
| Life | 2023 | 2022 | |
| Manufacturing and research equipment | 3-7 years | $843 | $843 |
| Capitalized internal use software and website development | 5 years | 103 | 103 |
| Computer equipment | 3-4 years | 43 | 43 |
| Furniture and fixtures | 7 years | 37 | 37 |
| Leasehold improvements | Life of lease | 88 | 13 |
| Property and equipment, gross | 1,114 | 1,039 | |
| Less: accumulated depreciation | (962) | (923) | |
| Property and equipment, net | $152 | $116 | |
Depreciation related to equipment utilized in the manufacturing process is recognized in cost of goods sold on the consolidated statements of operations and comprehensive loss. Depreciation expense for the years ended December 31, 2023 and 2022 was approximately $39,000 and $93,000, respectively. Approximately $3,000 of depreciation expense has been recognized in cost of goods sold for the year ended December 31, 2023. Approximately $22,000 of depreciation expense has been recognized in cost of goods sold for the year ended December 31, 2022.
Note 8 –Intangible Assets and Goodwill
Intangible Assets
Intangible assets at December 31, 2023 and December 31, 2022 are set forth in the table below. Gross carrying values and accumulated amortization of the Company’s intangible assets by type are as follows:
| December 31, 2023 · December 31, 2022 | |||||||
|---|---|---|---|---|---|---|---|
| Cost · Accumulated Amortization · Net · Cost · Accumulated Amortization · Net | |||||||
| (in thousands) | |||||||
| Tradenames, service marks and domain names | $50 | $(50) | $ | - | $50 | $(40) | $10 |
| Customer relationships | 540 | (159) | 381 | 540 | (127) | 413 | |
| Total intangible assets | $590 | $(209) | $381 | $590 | $(167) | $423 | |
The Company recognized amortization expense of approximately $42,000 for the years ended December 31, 2023 and December 31, 2022 in selling, general and administrative expenses on the accompanying consolidated statement of operations and comprehensive loss.
As of December 31, 2023, future amortization expense for each of the next five years is (in thousands):
| Fiscal Years | |
|---|---|
| 2024 | $32 |
| 2025 | 32 |
| 2026 | 32 |
| 2027 | 32 |
| 2028 | 32 |
The Company recognized approximately $1.0 million in intangible asset impairment charges during the year ended December 31, 2022, related to the fair value of assets held for sale. (See Note 3–Discontinued Operations).
Goodwill
Goodwill had a carrying value on the Company’s consolidated balance sheets of $0.8 million at December 31, 2023 and 2022, respectively. The Company concluded the carrying value of goodwill was not impaired as of December 31, 2023, or 2022 as the Company determined that it was not more likely than not that the fair value of goodwill was less than its carrying value.
Note 9 –License and Supply Agreement, net
On April 23, 2012, the Company entered into a License and Supply Agreement (as thereafter amended, the “License and Supply Agreement”) with Medica S.p.A. (“Medica”), an Italy-based medical product manufacturing company, for the marketing and sale of certain filtration products based upon Medica’s proprietary Medisulfone ultrafiltration technology in conjunction with the Company’s filtration products, and for an exclusive supply arrangement for the filtration products. Under the License and Supply Agreement, Medica granted to the Company an exclusive license, with right of sublicense, to market, promote, distribute, offer for sale and sell the filtration products worldwide, with certain limitations on territory, during the term of the License and Supply Agreement. In addition, the Company granted Medica an exclusive license under the Company’s intellectual property to make the filtration products during the term of the License and Supply Agreement. The filtration products covered under the License and Supply Agreement include both certain products based on Medica’s proprietary Versatile microfiber technology and certain filtration products based on Medica’s proprietary Medisulfone ultrafiltration technology. In December 2023, the Company signed a new agreement with Medica which extends the term until December 31, 2028, unless earlier terminated by either party in accordance with the terms of the License and Supply Agreement.
In exchange for the license, the gross value of the intangible asset capitalized was $2.3 million. License and supply agreement, net, on the consolidated balance sheet is $0.3 million and $0.4 million as of December 31, 2023 and 2022, respectively. Accumulated amortization is $2.0 million and $1.9 million as of December 31, 2023 and 2022, respectively. The intangible asset is being amortized as an expense over the life of the License and Supply Agreement. Amortization expense of $0.1 million was recognized in each of the years ended December 31, 2023 and 2022 on the consolidated statement of operations and comprehensive loss.
As of December 11, 2023, the Company contractually has agreed to pay interest per month at the EURIBOR 360-day rate plus 500 basis points calculated on the principal amount of any outstanding invoices that are overdue by more than 15 days beyond the original payment terms. There was no interest recognized for the years ended December 31, 2023 or 2022.
In addition, for the period beginning April 23, 2014 through December 31, 2023, the Company paid Medica a royalty rate of 3% of net sales of the filtration products sold, subject to reduction as a result of a supply interruption pursuant to the terms of the License and Supply Agreement. Royalty expense of $0.4 million and $0.3 million for the years ended December 31, 2023 and 2022, respectively, was recognized and is included in cost of goods sold on the consolidated statement of operations and comprehensive loss. Approximately $90,000 and $71,000 of this royalty expense was included in accounts payable as of December 31, 2023 and 2022, respectively.
Note 10 –Secured Note Payable
On March 27, 2018, the Company entered into a Secured Promissory Note Agreement (the “Secured Note”) with Tech Capital for a principal amount of $1.2 million. During the year ended December 31, 2023, the principal balance of the Secured Note was paid off. As of December 31, 2022, the principal balance of the Secured Note was $0.1 million.
The Secured Note has a maturity date of April 1, 2023. The unpaid principal balance accrues interest at a rate of 8% per annum. Principal and interest payments are due on the first day of each month commencing on May 1, 2018. The Secured Note is subject to terms and conditions of and is secured by security interests granted by the Company in favor of Tech Capital under the Loan and Security Agreement entered into on August 17, 2017 and subsequently amended on December 20, 2019 (the “Loan Agreement”). An event of default under such Loan Agreement is an event of default under the Secured Note and vice versa.
During each of the years ended December 31, 2023 and 2022, the Company made payments under the Secured Note of approximately $71,000 and $289,000 respectively. Included in the total payments made, approximately $1,000 and $18,000 was recognized as interest expense on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023 and 2022, respectively.
Note 11 –Leases
The Company has operating leases for corporate offices, warehouse space, an automobile and office equipment. The leases have remaining lease terms of 1 year to 5 years.
Lease cost, as presented below, includes costs associated with leases for which right-of-use (“ROU”) assets have been recognized as well as short-term leases.
The components of total lease costs were as follows (in thousands):
| Year ended December 31, 2023 | Year ended December 31, 2022 | |
|---|---|---|
| Operating lease cost | $334 | $351 |
| Finance lease cost: | ||
| Amortization of right-of-use assets | 7 | 12 |
| Interest on lease liabilities | 2 | 2 |
| Total finance lease cost | 9 | 14 |
| Variable lease cost | 44 | 53 |
| Total lease cost | $387 | $418 |
Supplemental cash flow information related to leases was as follows (in thousands):
| Year ended December 31, 2023 | Year ended December 31, 2022 | |
|---|---|---|
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows from operating leases | $408 | $365 |
| Financing cash flows from finance leases | $7 | $12 |
Supplemental balance sheet information related to leases was as follows (in thousands except years):
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Operating lease right-of-use assets | $1,803 | $972 |
| Finance lease right-of-use assets | $4 | $12 |
| Current portion of operating lease liabilities | $442 | $309 |
| Operating lease liabilities, net of current portion | 1,390 | 700 |
| Total operating lease liabilities | $1,832 | $1,009 |
| Current portion of finance lease liabilities | $4 | $8 |
| Finance lease liabilities, net of current portion | - | 4 |
| Total finance lease liabilities | $4 | $12 |
| Weighted average remaining lease term | ||
| Operating leases | 4.3 years | 3.9 years |
| Finance leases | 0.6 years | 1.5 years |
| Weighted average discount rate | ||
| Operating leases | 8.0% | 8.0% |
| Finance leases | 8.0% | 8.0% |
As of December 31, 2023, maturities of lease liabilities were as follows (in thousands):
| Operating Leases · Finance Leases | ||
|---|---|---|
| 2024 | $562 | $4 |
| 2025 | 435 | - |
| 2026 | 450 | - |
| 2027 | 450 | - |
| 2028 | 251 | - |
| Total future minimum lease payments | 2,148 | 4 |
| Less imputed interest | (316) | - |
| Total | $1,832 | $4 |
Note 12 -Accrued Expenses
Accrued expenses as of December 31, 2023 and 2022 were as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued bonus | $537 | $76 |
| Accrued directors’ fees | - | 126 |
| Accrued legal | 10 | 4 |
| Accrued sales commission | 117 | 36 |
| Accrued sales tax payable | 22 | 7 |
| Accrued franchise tax | 14 | 10 |
| Accrued other | 94 | 26 |
| Accrued expenses | $794 | $285 |
Note 13 -Income Taxes
There wasno income tax current or deferred tax benefit or expense recognized during the years ended December 31, 2023 and 2022.
A reconciliation of the income tax benefit computed at the statutory tax rate to the Company’s effective tax rate for the years ended December 31, 2023, and 2022 is as follows:
| Years Ended December 31, | ||||
|---|---|---|---|---|
| 2023 · 2022 | ||||
| U.S. federal statutory rate | 21.00% | 21.00% | ||
| State taxes | 12.22% | 4.79% | ||
| Expired NOLs and credits | (115.56)% | (12.78)% | ||
| Stock-based compensation | (4.54)% | (2.43)% | ||
| Federal research and development credits | - | % | 0.62% | |
| Foreign Rate Differential | - | % | 9.15% | |
| Other | 0.12% | 3.44% | ||
| Non-taxable Cancelation of Indebtedness | 19.14% | - | % | |
| Valuation allowance | 67.62% | (23.78)% | ||
| Effective tax rate | - | % | - | % |
Significant components of the Company’s deferred tax assets (liabilities) as of December 31, 2023 and 2022 are as follows (in thousands):
| December 31, | ||||
|---|---|---|---|---|
| 2023 · 2022 | ||||
| Deferred tax assets: | ||||
| Net operating loss carry forwards | $16,700 | $17,672 | ||
| Research and development credits | 1,087 | 1,401 | ||
| Nonqualified stock option compensation expense | 613 | 543 | ||
| Lease liabilities | 449 | 243 | ||
| Capital loss carryforwards | 2,072 | 1,946 | ||
| Fixed and intangible basis difference | - | 328 | ||
| Other temporary book - tax differences | 713 | 243 | ||
| Total deferred tax assets | 21,634 | 22,376 | ||
| Deferred tax liabilities: | ||||
| Lease right-of-use assets | (442) | (234) | ||
| Fixed and intangible asset basis difference | (116) | - | ||
| Total deferred tax liabilities | (558) | (234) | ||
| Deferred tax assets, net | 21,076 | 22,142 | ||
| Valuation allowance for deferred tax assets | (21,076) | (22,142) | ||
| Net deferred tax assets after valuation allowance | $ | - | $ | - |
A valuation allowance has been recognized to offset the Company’s net deferred tax asset as it is more likely than not that such net asset will not be realized. The Company primarily considered its historical loss and potential Internal Revenue Code Section 382 limitations to arrive at its conclusion that a valuation allowance was required. The Company’s valuation allowance decreased approximately $1.1 million from December 31, 2022 to December 31, 2023.
At December 31, 2023, the Company had Federal income tax net operating loss carryforwards of $77.3 million and State income tax net operating loss carryforwards of $6.8 million. The Company had Federal research and development tax credit carryforwards of $1.1 million at December 31, 2023. The Company’s net operating losses and research and development tax credits may ultimately be limited by Section 382 of the Internal Revenue Code and, as a result, the Company may be unable to offset future taxable income (if any) with losses, or its tax liability with credits, before such losses and credits expire. Included in the Federal net operating loss carryforwards are $14 million of losses generated from 2018 onward that have an indefinite carryover period. The remaining Federal and New Jersey net operating loss carryforwards and Federal and New Jersey tax credit carryforwards will expire at various times between 2024 and 2041 unless utilized.
The Company has analyzed the tax positions taken or expected to be taken in its tax returns and concluded it has no liability related to uncertain tax positions. The Company is subject to income tax examinations by major taxing authorities for all tax years subsequent to 2018 and does not anticipate a change in its uncertain tax positions within the next twelve months. The Company’s policy is to report interest and penalties, if any, related to unrecognized tax benefits in income tax expense.
Note 14 -Stock Plans and Share-Based Payments
The fair value of stock options and restricted stock is recognized as stock-based compensation expense in the Company’s consolidated statement of operations and comprehensive loss. The Company calculates stock-based compensation expense in accordance with ASC 718. The fair value of stock-based awards is amortized over the vesting period of the award.
Stock Plans
In 2015, the Board of Directors adopted the Nephros, Inc. 2015 Equity Incentive Plan (“2015 Plan”). As of December 31, 2023, including amendments approved by the Board of Directors,2,547,400 shares of common stock were approved for issuance pursuant to stock options, restricted stock and other equity incentive awards to the Company’s employees, directors and consultants. The maximum contractual term for stock options granted under the 2015 Plan is 10 years.
As of December 31, 2023, options to purchase 1,774,819 shares of common stock had been issued to employees under the 2015 Plan and were outstanding. The options issued to employees expire on various dates between April 15, 2025 and December 27, 2033. Taking into account all options and restricted stock granted under the 2015 Plan, there are 65,580 shares available for future grant under the 2015 Plan. Generally, grants vest based on a service condition only and vest betweentwo tofour years.
The Company’s previously adopted and approved plan, the 2004 Stock Incentive Plan (“2004 Plan”), expired in the year ended December 31, 2014. As of December 31, 2023, options to purchase 14,387 shares of common stock had been issued to employees under the 2004 Plan and were outstanding. The options expire on various dates between February 5, 2024 and March 26, 2024. No shares are available for future grants under the 2004 Plan. Options currently outstanding are fully vested.
On November 1, 2023, the Company issued 122,524 stock options outside of the 2015 Plan to the Company’s new Chief Financial Officer. The terms for these options are identical to those issued to employees under the 2015 Plan.
Stock Options
The Company has elected to recognize forfeitures as they occur. Stock-based compensation expense recognized for the years ended December 31, 2023 and 2022 was $1.0 million and $0.9 million, respectively.
For the year ended December 31, 2023, $1.0 million and approximately $39,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying consolidated statement of operations and comprehensive loss. For the year ended December 31, 2022, $0.8 million and approximately $63,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying consolidated statement of operations and comprehensive loss.
The following table issued summarizes the option activity for the years ended December 31, 2023 and 2022:
| Shares | Weighted Average Exercise Price | |
|---|---|---|
| Outstanding at December 31, 2021 | 1,426,510 | $6.29 |
| Options granted | 279,115 | 1.91 |
| Options forfeited or expired | (340,260) | 6.88 |
| Options exercised | - | - |
| Outstanding at December 31, 2022 | 1,365,365 | $5.25 |
| Options granted | 583,089 | 1.47 |
| Options forfeited or expired | (102,722) | 5.87 |
| Options exercised (1) | (56,526) | 2.47 |
| Outstanding at December 31, 2023 | 1,789,206 | $4.07 |
| (1) | 56,526 options were exercised via cashless exercise which resulted in 16,576 shares issued. |
The following table summarizes the options exercisable and vested and expected to vest as of December 31, 2023 and 2022.
| Shares | Weighted Average Exercise Price | |
|---|---|---|
| Exercisable at December 31, 2022 | 968,441 | $5.55 |
| Vested and expected to vest at December 31, 2022 | 1,342,342 | $5.26 |
| Exercisable at December 31, 2023 | 1,171,824 | $5.25 |
| Vested and expected to vest at December 31, 2023 | 1,753,398 | $4.12 |
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model. The below assumptions for the risk-free interest rates, expected dividend yield, expected lives and expected stock price volatility were utilized for the stock options granted during the year ended December 31, 2023.
| Assumption for Option Grants | 2023 | 2022 |
|---|---|---|
| Stock Price Volatility | 72.40% | 75.44% |
| Risk-Free Interest Rates | 3.71% | 2.74% |
| Expected Life (in years) | 6.22 | 5.64 |
| Expected Dividend Yield | 0% | 0% |
Expected volatility is based on historical volatility of the Company’s common stock at the time of grant. The risk-free interest rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected life of the options. For the expected life, the Company is using the simplified method as described in the SEC Staff Accounting Bulletin 107. This method assumes that stock option grants will be exercised based on the average of the vesting periods and the option’s life.
The weighted-average fair value of options granted in 2023 and 2022 is $0.99 and $1.25, respectively. The aggregate intrinsic values of stock options outstanding and stock options vested or expected to vest as of December 31, 2023 was approximately $1.4 million and $0 respectively. A stock option has intrinsic value, at any given time, if and to the extent that the exercise price of such stock option is less than the market price of the underlying common stock at such time. The weighted-average remaining contractual life of options vested or expected to vest as of December 31, 2023 was approximately 6.4 years.
The intrinsic values of stock options exercised was approximately $58,000 for the year ended December 31, 2023. No stock options were exercised for the year ended December 31, 2022.
As of December 31, 2023, there was $0.6 million of total unrecognized compensation cost related to unvested share-based compensation awards granted under the equity compensation plans which will be amortized over the weighted average remaining requisite service period of 2.97 years.
There wasno tax benefit related to expense recognized in the twelve months ended December 31, 2023 and 2022, as the Company is in a net operating loss position.
Restricted Stock
The Company has issued restricted stock as compensation for the services of certain employees and non-employee directors. The grant date fair value of restricted stock is based on the fair value of the common stock on the date of grant, and compensation expense is recognized based on the period in which the restrictions lapse.
The following table summarizes restricted stock activity for the years ended December 31, 2023 and 2022:
| Shares | Weighted Average Grant Date Fair Value | |
|---|---|---|
| Nonvested at December 31, 2021 | 59,732 | $8.07 |
| Granted | - | - |
| Vested | (44,732) | 7.87 |
| Forfeited | (15,000) | 8.66 |
| Nonvested at December 31, 2022 | - | - |
| Granted | 299,670 | 1.47 |
| Vested | (187,503) | 1.08 |
| Nonvested at December 31, 2023 | 42,167 | $3.18 |
The total fair value of restricted stock that vested during the years ended December 31, 2023 and 2022 was approximately $0.2 million and $0.4 million, respectively.
Total stock-based compensation expense for restricted stock was approximately $322,000 and $42,000 for the year ended December 31, 2023 and 2022, respectively and is recognized in selling, general and administrative expenses on the accompanying consolidated statement of operations and comprehensive loss.
Approximately $154,000 of stock compensation expense was recognized in the year ended December 31, 2022 related to restricted stock granted to board members and employees for the year ended December 31, 2023 to settle liabilities for services incurred in the respective prior fiscal year.
As of December 31, 2023, there was approximately $15,000 of unrecognized compensation expense related to restricted stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining requisite service period of 0.4 years. As of December 31, 2022, there wasno unrecognized compensation expense related to the restricted stock awards.
The aggregate shares of common stock legally issued and outstanding as of December 31, 2023 is greater than the aggregate shares of common stock outstanding for accounting purposes by the amount of unvested restricted shares.
SRP Equity Incentive Plan
SRP’s 2019 Equity Incentive Plan was approved on May 7, 2019 under which 150,000 shares of SRP’s common stock are reserved for the issuance of options and other awards. This plan is no longer operational, due to the wind down of SRP’s operations and its April 2023 dissolution.
Due to the Company’s deemed acquisition of the non-controlling interest in SRP during the year ended December 31, 2023, all remaining equity-based awards have been forfeited and no further expense will be incurred related to these awards. There were no SRP stock options or other equity awards granted during the year ended December 31, 2023. For the year ended December 31, 2023, a credit of approximately ($27,000) was recognized for expense related to the SRP equity-based awards. Stock-based compensation expense related to the SRP stock grants was approximately $47,000 during the year ended December 31, 2022. Stock-based compensation expense related to the SRP equity-based awards is included in selling, general and administrative expenses on the accompanying consolidated statement of operations and comprehensive loss. Stock-based compensation expense related to the SRP stock options is presented by the Company as noncontrolling interest on the consolidated balance sheet as of December 31, 2022.
**Note 15 -Stockholders’ Equity **
Noncontrolling Interest
Pursuant to the terms and conditions of a Series A Preferred Stock Purchase Agreement, dated September 9, 2018, among SRP and the purchasers identified therein (the “SRP Purchase Agreement”), SRP sold to such purchasers an aggregate of 600,000 shares of its Series A Preferred Stock (the “Series A Preferred”) at a price of $5.00 per share resulting in total gross proceeds of $3.0 million. On February 1, 2022, SRP and such purchasers amended the SRP Purchase Agreement to allow for the sale of an additional 100,003 shares of Series A Preferred, all of which were sold on February 4, 2022, for aggregate gross proceeds of $500,015 and otherwise on the same terms and conditions as set forth in the SRP Purchase Agreement. Approximately $188,000 of the proceeds from the February 2022 sales were recorded as an increase to the equity of the non-controlling interests. The Company purchased 62,500 shares of SRP’s Series A Preferred at such closing and, as a result, maintained its 62.5% stock ownership position in SRP. The other purchasers at the February 2022 closing included the Company’s Chief Executive Officer, who purchased 313 shares, and Lambda Investors LLC (“Lambda”), an affiliate of Wexford Capital, which together with its affiliates owns approximately 36% of the Company’s common stock, which purchased 25,938 shares of the Series A Preferred in February 2022. Such purchases were made on the same terms as all other purchasers. In addition to the funds provided by the SRP Purchase Agreement, the Company loaned to SRP to the principal amount of $1.3 million, $1.0 million of which was advanced during the year ended December 31, 2020.
As of December 31, 2022, the non-controlling interest in SRP held by holders of the Series A Preferred was classified as equity on the accompanying consolidated balance sheet, as the non-controlling interest is redeemable only upon the occurrence of events that are within the control of the Company. As a result of the adoption of the plan of liquidation and dissolution by SRP’s stockholders and the subsequent filing of a certificate of dissolution of SRP with the State of Delaware, the redemption feature related to the Series A Preferred Stock effectively terminated. As such, the value of the Series A Preferred Stock previously presented in non-controlling interest was reclassified to additional paid in capital as the Company retained control of SRP.
In March 2023, the board of directors of SRP adopted, and the stockholders of SRP approved, a plan to wind down SRP’s operations and dissolve, and in April 2023, SRP filed a certificate of dissolution with the State of Delaware. In accordance with its plan of dissolution, after SRP satisfied its other outstanding liabilities, SRP assigned to the Company all of its remaining assets, including its intellectual property rights, in satisfaction of outstanding indebtedness owed to the Company in the approximate amount of $1.5 million. No other assets are available for distribution to any of SRP’s stockholders, including the Company, in respect of their shares of SRP capital stock, including the Series A Preferred. As a result of the dissolution described above, it was determined approximately $24,000 of inventory likely had no value, and was written off in the period ended March 31, 2023.
Warrants
The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. The company hadno outstanding warrants at December 31, 2023 and December 31, 2022.
Warrants Exercised During 2022
During the year ended December 31, 2022, warrants to purchase 60,374 shares of the Company’s common stock were exercised, resulting in proceeds of $0.2 million and the issuance of 60,374 shares of the Company’s common stock. Of the warrants exercised during the year ended December 31, 2022, warrants to purchase 14,815 shares of the Company’s common stock were exercised by members of management, resulting in proceeds of approximately $40,000. Warrants to purchase 63,102 shares of the Company’s common stock expired unexercised during the year ended December 31, 2022.
Note 16 –Savings Incentive Match Plan
On January 1, 2017, the Company established a Savings Incentive Match Plan for Employees Individual Retirement Account (SIMPLE IRA), which covers all employees. The SIMPLE IRA Plan provides for voluntary employee contributions up to statutory IRA limitations. The Company matches 100% of employee contributions to the SIMPLE IRA Plan, up to 3% of each employee’s salary. The Company contributed and expensed approximately $91,000 and $104,000 to the SIMPLE IRA in 2023 and 2022, respectively.
Note 17 -Commitments and Contingencies
Purchase Commitments
In exchange for the rights granted under the License and Supply Agreement with Medica (see Note 9 – License and Supply Agreement, net), the Company agreed to make certain minimum annual aggregate purchases from Medica over the term of the License and Supply Agreement. For the year ended December 31, 2023, the Company agreed to make minimum annual aggregate purchases from Medica of €3.8 million (approximately $4.1 million). For the year ended December 31, 2023, aggregate purchase commitments totaled €4.9 million (approximately $5.3 million). All minimum purchase requirements were met.
Future purchase commitments under the License and Supply Agreement with Medica are as follows:
| ● | 2024: €4,208,000 |
| ● | 2025: €4,629,000 |
| ● | 2026: €4,976,000 |
| ● | 2027: €5,349,000 |
| ● | 2028: €5,750,000 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.