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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended: June 30, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from: _______ to _______
Commission
File Number: 001-32288
NEPHROS,
INC.
(Exact
name of registrant as specified in its charter)
delaware |
|
13-3971809 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
380
Lackawanna Place
South
Orange, NJ |
|
07079 |
(Address of principal executive
offices) |
|
(Zip Code) |
(201)
343-5202
Registrant’s
telephone number, including area code
N/A
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
symbol |
|
Name
of exchange on which registered |
Common stock, par value
$0.001 per share |
|
NEPH |
|
The Nasdaq Stock Market
LLC |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ YES ☐ NO
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ YES ☐ NO
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
Large accelerated filer ☐ |
Accelerated filer ☐ |
Non-accelerated filer ☒ |
Smaller reporting company ☒ |
|
Emerging growth company ☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ YES ☒ NO
As
of August 5, 2024, 10,544,139 shares of the registrant’s common stock, $0.001 par value per share, were outstanding.
NEPHROS,
INC. AND SUBSIDIARIES
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements.
NEPHROS,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share and per share amounts)
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 3,080 | | |
$ | 4,307 | |
Accounts receivable, net | |
| 1,878 | | |
| 1,496 | |
Inventory | |
| 2,803 | | |
| 2,470 | |
Prepaid expenses and other current assets | |
| 165 | | |
| 132 | |
Total current assets | |
| 7,926 | | |
| 8,405 | |
Property and equipment, net | |
| 186 | | |
| 152 | |
Lease right-of-use assets | |
| 1,551 | | |
| 1,807 | |
Intangible assets, net | |
| 365 | | |
| 381 | |
Goodwill | |
| 759 | | |
| 759 | |
License and supply agreement, net | |
| 243 | | |
| 271 | |
Other assets | |
| 70 | | |
| 86 | |
TOTAL ASSETS | |
$ | 11,100 | | |
$ | 11,861 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,159 | | |
$ | 873 | |
Accrued expenses | |
| 435 | | |
| 794 | |
Current portion of lease liabilities | |
| 358 | | |
| 446 | |
Total current liabilities | |
| 1,952 | | |
| 2,113 | |
Lease liabilities, net of current portion | |
| 1,222 | | |
| 1,390 | |
TOTAL LIABILITIES | |
| 3,174 | | |
| 3,503 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES (Note 13) | |
| - | | |
| - | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Preferred stock, $.001 par value; 5,000,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023. | |
| - | | |
| - | |
Common stock, $.001 par value; 40,000,000 shares authorized at June 30, 2024 and December 31, 2023; 10,544,139 and 10,543,675 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively. | |
| 11 | | |
| 10 | |
Additional paid-in capital | |
| 152,779 | | |
| 152,754 | |
Accumulated deficit | |
| (144,864 | ) | |
| (144,406 | ) |
TOTAL STOCKHOLDERS’ EQUITY | |
| 7,926 | | |
| 8,358 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 11,100 | | |
$ | 11,861 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
NEPHROS,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except share and per share amounts)
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Net revenue: | |
| | | |
| | | |
| | | |
| | |
Product revenues | |
$ | 3,208 | | |
$ | 3,537 | | |
$ | 6,714 | | |
$ | 7,199 | |
Royalty and other revenues | |
| 44 | | |
| 8 | | |
| 60 | | |
| 43 | |
Total net revenues | |
| 3,252 | | |
| 3,545 | | |
| 6,774 | | |
| 7,242 | |
Cost of goods sold | |
| 1,340 | | |
| 1,466 | | |
| 2,675 | | |
| 3,052 | |
Gross margin | |
| 1,912 | | |
| 2,079 | | |
| 4,099 | | |
| 4,190 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
| 1,941 | | |
| 2,239 | | |
| 4,083 | | |
| 4,363 | |
Research and development | |
| 254 | | |
| 221 | | |
| 466 | | |
| 460 | |
Depreciation and amortization | |
| 34 | | |
| 54 | | |
| 67 | | |
| 108 | |
Total operating expenses | |
| 2,229 | | |
| 2,514 | | |
| 4,616 | | |
| 4,931 | |
Operating loss | |
| (317 | ) | |
| (435 | ) | |
| (517 | ) | |
| (741 | ) |
Other (expense) income: | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| - | | |
| - | | |
| (1 | ) | |
| (1 | ) |
Interest income | |
| 21 | | |
| 13 | | |
| 46 | | |
| 25 | |
Other income (expense), net | |
| 7 | | |
| (11 | ) | |
| 14 | | |
| (22 | ) |
Total other expense: | |
| 28 | | |
| 2 | | |
| 59 | | |
| 2 | |
Net loss | |
| (289 | ) | |
| (433 | ) | |
| (458 | ) | |
| (739 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share, basic and diluted | |
$ | (0.03 | ) | |
$ | (0.04 | ) | |
$ | (0.04 | ) | |
$ | (0.07 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 10,509,937 | | |
| 10,297,429 | | |
| 10,505,833 | | |
| 10,297,429 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
NEPHROS,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(In
thousands, except share amounts)
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | |
|
Deficit | | |
Subtotal | | |
Interest | | |
Equity | |
| |
Three and six months ended June 30, 2024 | |
| |
| |
| |
Common Stock | | |
Additional Paid-in | |
|
Accumulated | | |
| | |
Noncontrolling | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | |
|
Deficit | | |
Subtotal | | |
Interest | | |
Equity | |
Balance, December 31, 2023 | |
| 10,501,508 | | |
$ | 10 | | |
$ | 152,754 | |
|
$ | (144,406 | ) | |
$ | 8,358 | | |
$ | - | | |
$ | 8,358 | |
Net loss | |
| - | | |
| - | | |
| - | |
|
| (169 | ) | |
| (169 | ) | |
| - | | |
| (169 | ) |
Stock option exercises | |
| 464 | | |
| - | | |
| - | |
|
| - | | |
| - | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| (9 | ) |
|
| - | | |
| (9 | ) | |
| - | | |
| (9 | ) |
Balance, March 31, 2024 | |
| 10,501,972 | | |
$ | 10 | | |
$ | 152,745 | |
|
$ | (144,575 | ) | |
$ | 8,180 | | |
$ | - | | |
$ | 8,180 | |
| |
| | | |
| | | |
| | |
|
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
$ | - | | |
$ | - | |
|
$ | (289 | ) | |
$ | (289 | ) | |
$ | - | | |
$ | (289 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| 35 | |
|
| - | | |
| 35 | | |
| - | | |
| 35 | |
Restricted stock vesting | |
| 42,167 | | |
| 1 | | |
| (1 | ) |
|
| - | | |
| - | | |
| - | | |
| - | |
Balance, June 30, 2024 | |
| 10,544,139 | | |
$ | 11 | | |
$ | 152,779 | |
|
$ | (144,864 | ) | |
$ | 7,926 | | |
$ | - | | |
$ | 7,926 | |
| |
Three and six months ended June 30, 2023 | |
| |
| |
| |
Common Stock | | |
Additional Paid-in | |
|
Accumulated | | |
| | |
Noncontrolling | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | |
|
Deficit | | |
Subtotal | | |
Interest | | |
Equity | |
Balance, December 31, 2022 | |
| 10,297,429 | | |
$ | 10 | | |
$ | 148,413 | |
|
$ | (142,831 | ) | |
$ | 5,592 | | |
$ | 3,289 | | |
$ | 8,881 | |
Net loss | |
| - | | |
| - | | |
| - | |
|
| (306 | ) | |
| (306 | ) | |
| - | | |
| (306 | ) |
Change in non-controlling interest | |
| - | | |
| - | | |
| 3,262 | |
|
| - | | |
| 3,262 | | |
| (3,262 | ) | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| 346 | |
|
| - | | |
| 346 | | |
| (27 | ) | |
| 319 | |
Balance, March 31, 2023 | |
| 10,297,429 | | |
$ | 10 | | |
$ | 152,021 | |
|
$ | (143,137 | ) | |
$ | 8,894 | | |
$ | - | | |
$ | 8,894 | |
Balance | |
| 10,297,429 | | |
$ | 10 | | |
$ | 152,021 | |
|
$ | (143,137 | ) | |
$ | 8,894 | | |
$ | - | | |
$ | 8,894 | |
| |
| | | |
| | | |
| | |
|
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
$ | - | | |
$ | - | |
|
$ | (433 | ) | |
$ | (433 | ) | |
$ | - | | |
$ | (433 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| 194 | |
|
| - | | |
| 194 | | |
| - | | |
| 194 | |
Balance, June 30, 2023 | |
| 10,297,429 | | |
$ | 10 | | |
$ | 152,215 | |
|
$ | (143,570 | ) | |
$ | 8,655 | | |
$ | - | | |
$ | 8,655 | |
Balance | |
| 10,297,429 | | |
$ | 10 | | |
$ | 152,215 | |
|
$ | (143,570 | ) | |
$ | 8,655 | | |
$ | - | | |
$ | 8,655 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
NEPHROS,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
| |
2024 | | |
2023 | |
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (458 | ) | |
$ | (739 | ) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |
| | | |
| | |
Depreciation of property and equipment | |
| 22 | | |
| 19 | |
Amortization of intangible assets, license and supply agreement and finance lease right-of-use asset | |
| 47 | | |
| 88 | |
Stock-based compensation | |
| 26 | | |
| 513 | |
Inventory impairments and writeoffs | |
| 180 | | |
| 106 | |
Gain on foreign currency transactions | |
| (5 | ) | |
| - | |
Gain on disposal of equipment | |
| (5 | ) | |
| - | |
Decrease (increase) in operating assets: | |
| | | |
| | |
Accounts receivable | |
| (382 | ) | |
| (290 | ) |
Inventory | |
| (513 | ) | |
| 920 | |
Prepaid expenses and other current assets | |
| (33 | ) | |
| 35 | |
Right-of-use assets | |
| 252 | | |
| 160 | |
Other assets | |
| 17 | | |
| 2 | |
(Decrease) increase in operating liabilities: | |
| | | |
| | |
Accounts payable | |
| 289 | | |
| (437 | ) |
Accrued expenses | |
| (358 | ) | |
| 285 | |
Lease liabilities | |
| (252 | ) | |
| (160 | ) |
Net cash (used in) provided by operating activities | |
| (1,173 | ) | |
| 502 | |
INVESTING ACTIVITIES: | |
| | | |
| | |
Proceeds from sale of equipment | |
| 5 | | |
| - | |
Purchase of property and equipment | |
| (55 | ) | |
| - | |
Net cash used in investing activities | |
| (50 | ) | |
| - | |
FINANCING ACTIVITIES: | |
| | | |
| | |
Principal payments on finance lease liability | |
| (4 | ) | |
| (4 | ) |
Principal payments on equipment financing | |
| - | | |
| (1 | ) |
Payments on secured note payable | |
| - | | |
| (71 | ) |
Net cash (used in) financing activities | |
| (4 | ) | |
| (76 | ) |
Net (decrease) increase in cash and cash equivalents | |
| (1,227 | ) | |
| 426 | |
Cash and cash equivalents, beginning of period | |
| 4,307 | | |
| 3,634 | |
Cash and cash equivalents, end of period | |
$ | 3,080 | | |
$ | 4,060 | |
Supplemental disclosure of cash flow information | |
| | | |
| | |
Cash paid for interest | |
$ | 1 | | |
$ | 2 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated interim financial statement
NEPHROS,
INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (unaudited)
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.
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, and 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 – Basis of Presentation and Liquidity
Interim
Financial Information
The
accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting
principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 and Article 10
of Regulation S-X. The condensed consolidated balance sheet as of December 31, 2023 was derived from the Company’s audited financial
statements. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. Results
as of and for the six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024.
The
condensed consolidated interim financial statements and notes thereto should be read in conjunction with the consolidated financial statements
and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
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.
Consolidation
The
accompanying condensed consolidated financial statements include the accounts of Nephros, Inc. and its subsidiary, 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
condensed consolidated financial statements.
Use
of Estimates
The
preparation of consolidated financial statements in conformity with 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.
Liquidity
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. See “Note 11
– Stockholders’ Equity – Noncontrolling Interest” Accordingly, as of June 30, 2024, there was no outstanding
balance of this loan.
The
Company has sustained operating losses every quarter through June 30, 2024, generating an accumulated deficit of $144.9 million as of
June 30, 2024. However, in 2023, the Company’s operating cash flow was positive due to increased sales, improved gross margins,
careful expense management, a reduction in inventory, and the dispositions of the Pathogen Detection Systems and SRP businesses. These
actions resulted in the Company generating cash from operations of approximately $0.8 million for the twelve months ended December 31,
2023. Conversely, net cash from operations was negative for the six months ended June 30, 2024 due to an operating loss, payment of prior
year annual bonuses, and an increase in inventory and accounts receivable. The Company continues to focus on growth in sales and managing
tight expenses with the goal of turning cash flow positive from operations. The investment in inventory in the first quarter of 2024 was preparing
for higher volumes of key products in the future. The Company believes that the tight focus on operations and its current 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 condensed
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.
Recent
Accounting Pronouncements, Not Yet Effective
In
March 2024, the FASB issued ASU 2024-01, “ASC 718-Scope Application of Profits Interest and Similar Awards,” which provides
guidance to assist entities in determining whether profits interest and similar awards should be accounted for in accordance with Topic
718, Compensation—Stock Compensation. The guidance is effective for the Company’s fiscal year 2025, including interim periods.
Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its condensed consolidated financial statements.
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 condensed 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.
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 three months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Schedule of Revenues and Accounts Receivable Percentage of Major Customers
Customer | |
2024 | | |
2023 | |
A | |
| 22 | % | |
| 18 | % |
B | |
| 8 | % | |
| 11 | % |
D | |
| 3 | % | |
| 11 | % |
Total | |
| 33 | % | |
| 40 | % |
For
the six months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 27 | % | |
| 19 | % |
B | |
| 7 | % | |
| 10 | % |
C | |
| 2 | % | |
| 13 | % |
Total | |
| 36 | % | |
| 42 | % |
As
of June 30, 2024, and December 31, 2023, the following customers accounted for the following percentages of the Company’s accounts
receivable, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 16 | % | |
| 12 | % |
E | |
| 12 | % | |
| - | |
Total | |
| 28 | % | |
| 12 | % |
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 doubtful accounts 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 credit losses was approximately $11,000 as of each of the
periods ended June 30, 2024, and December 31, 2023.
Note
3 – 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 for the three and
six months ended June 30, 2024, or 2023. In addition to product revenue, the Company recognizes revenue related to services to customers,
royalties, and other agreements in accordance with the five-step model in ASC 606. Other revenues recognized for the three and six months
ended June 30, 2024, were approximately $44,000 and $60,000, respectively. Other revenues recognized for the three and six months ended
June 30, 2023 were approximately $8,000 and $43,000, respectively.
Note
4 – 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.
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
June 30, 2024 the Company’s cash equivalents consisted of money market funds. At December 31,2023 the Company’s cash equivalents
consisted of money market funds and a certificate of deposit. 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
June 30, 2024 and December 31, 2023, the fair value measurements of the Company’s assets and liabilities measured on a recurring
basis were as follows:
Schedule
of Assets and Liabilities Measured at Fair Value on Recurring Basis
(in thousands) | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | | |
Significant Other Observable Inputs (Level 2) | | |
Significant Unobservable Inputs (Level 3) | |
| |
| |
June 30, 2024 | |
| | | |
| | | |
| | |
Cash | |
$ | 1,403 | | |
$ | - | | |
$ | - | |
Money market funds | |
| 1,677 | | |
| - | | |
| - | |
| |
| - | | |
| | | |
| | |
Cash and cash equivalents | |
$ | 3,080 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Cash | |
$ | 274 | | |
$ | - | | |
$ | - | |
Money market funds | |
| 2,515 | | |
| - | | |
| - | |
Certificate of deposit | |
| 1,518 | | |
| - | | |
| - | |
Cash and cash equivalents | |
$ | 4,307 | | |
$ | - | | |
$ | - | |
Assets
and Liabilities Not Measured at Fair Value on a Recurring Basis
The
carrying amounts of accounts receivable, accounts payable and accrued expenses approximate fair value due to their short-term nature.
The
carrying amounts of the lease liabilities and equipment financing approximate fair value as of June 30, 2024 and December 31, 2023 because
those financial instruments bear interest at rates that approximate current market rates for similar agreements with similar maturities
and quality.
Note
5 – 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 June 30, 2024 and December 31, 2023, were as follows:
Schedule
of Inventory, Net
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(in thousands) | |
Finished goods | |
$ | 2,413 | | |
$ | 2,144 | |
Raw materials | |
| 390 | | |
| 326 | |
Total inventory | |
$ | 2,803 | | |
$ | 2,470 | |
Note
6 – Intangible Assets and Goodwill
Intangible
Assets
Intangible
assets as of June 30, 2024 and December 31, 2023 are set forth in the table below. Gross carrying values and accumulated amortization
of the Company’s intangible assets by type are as follows:
Schedule
of Intangible Assets
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Cost | | |
Accumulated Amortization | | |
Net | | |
Cost | | |
Accumulated Amortization | | |
Net | |
| |
(in thousands) | |
Customer relationships | |
$ | 540 | | |
| (175 | ) | |
$ | 365 | | |
$ | 540 | | |
| (159 | ) | |
| 381 | |
Total intangible assets | |
$ | 540 | | |
$ | (175 | ) | |
$ | 365 | | |
$ | 540 | | |
$ | (159 | ) | |
$ | 381 | |
The
Company recognized amortization expense of approximately $8,000 and $11,000 for the three months ended June 30, 2024 and June 30, 2023,
respectively. All were recognized in selling, general and administrative expenses on the accompanying condensed consolidated statement
of operations.
As
of June 30, 2024, future amortization expense for each of the next five years is (in thousands):
Schedule
of Future Amortization Expense
Fiscal Years | |
| |
2024 (excluding the six months ended June 30, 2024) | |
$ | 16 | |
2025 | |
| 32 | |
2026 | |
| 32 | |
2027 | |
| 32 | |
2028 | |
| 32 | |
2029 | |
| 32 | |
Goodwill
Goodwill
has a carrying value on the Company’s condensed consolidated balance sheets of approximately $0.8 million at June 30, 2024 and
December 31, 2023.
Note
7 – 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 to 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 includes 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 condensed consolidated balance sheet is $0.2 million and $0.3 million as of June 30, 2024 and December 31, 2023, respectively. Accumulated
amortization is $2.0 and $1.9 million as of June 30, 2024 and December 31, 2023, respectively. The intangible asset is being amortized
as an expense over the life of the License and Supply Agreement. Amortization expense of approximately $14,000 and $33,000 was recognized
in each of the three months ended June 30, 2024 and 2023, respectively on the condensed consolidated statement of operations.
As
of December 11, 2023, the Company has agreed with Medica 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 six months ended June 30, 2024 or June 30, 2023.
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. Approximately $95,000 for the three months ended June 30, 2023 was recognized as royalty expense and is included in cost of
goods sold on the condensed consolidated statement of operations. Approximately $191,000 for the six months ended
June 30, 2023 was recognized as royalty expense and is included in cost of goods sold on the condensed consolidated statement of operations. Approximately $95,000 of this royalty expense was included in accounts payable as of June 30, 2023. Starting
in 2024, the Company is no longer required to pay Medica royalties.
Note
8 – 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. As of June 30, 2023, the principal balance of the Secured Note was paid off.
The
Secured Note had a maturity date of April 1, 2023. The unpaid principal balance accrued interest at a rate of 8% per annum. Principal
and interest payments were due on the first day of each month commencing on May 1, 2018. The Secured Note was subject to terms and conditions
of and was 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 was an event of default under the Secured Note and vice versa.
During
the three months ended June 30, 2023, no payments were made under the Secured Note, as the Note was repaid in full at March 31, 2023.
During
the six months ended June 30, 2023, the Company made payments under the Secured Note of approximately $71,000. Included in the total
payments made, approximately $1,000 was recognized as interest expense on the condensed consolidated statements of operations for the six months ended June 30, 2023.
Note
9 – Leases
The
Company has operating leases for corporate offices 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:
Schedule of Components of Lease Cost
| |
Three
months ended June 30, 2024 | | |
Three
months ended June 30, 2023 | |
| |
(in thousands) | |
Operating lease cost | |
$ | 127 | | |
$ | 90 | |
Finance lease cost: | |
| | | |
| | |
Amortization of right-of-use assets | |
| 2 | | |
| 2 | |
Interest on lease liabilities | |
| 1 | | |
| 1 | |
Total finance lease cost | |
| 3 | | |
| 3 | |
Variable lease cost | |
| 14 | | |
| 3 | |
Total lease cost | |
$ | 144 | | |
$ | 96 | |
| |
Six months ended June 30, 2024 | | |
Six months ended June 30, 2023 | |
| |
(in thousands) | |
Operating lease cost | |
$ | 252 | | |
$ | 182 | |
Finance lease cost: | |
| | | |
| | |
Amortization of right-of-use assets | |
| 4 | | |
| 4 | |
Interest on lease liabilities | |
| 2 | | |
| 2 | |
Total finance lease cost | |
| 6 | | |
| 6 | |
Variable lease cost | |
| 25 | | |
| 7 | |
Total lease cost | |
$ | 283 | | |
$ | 195 | |
Supplemental
cash flow information related to leases was as follows:
Schedule of Supplemental Cash Flow Information Related to Leases
| |
Six months ended June 30, 2024 | | |
Six months ended June 30, 2023 | |
| |
(in thousands) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 316 | | |
$ | 160 | |
Financing cash flows from finance leases | |
$ | 4 | | |
$ | 4 | |
Supplemental
balance sheet information related to leases was as follows:
Schedule of Supplemental Balance Sheet Information Related to Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(in thousands) | |
Operating lease right-of-use assets | |
$ | 1,550 | | |
$ | 1,803 | |
Finance lease right-of-use assets | |
$ | 1 | | |
$ | 4 | |
| |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 357 | | |
$ | 442 | |
Operating lease liabilities, net of current portion | |
| 1,222 | | |
| 1,390 | |
Total operating lease liabilities | |
$ | 1,579 | | |
$ | 1,832 | |
| |
| | | |
| | |
Current portion of finance lease liabilities | |
$ | 1 | | |
$ | 4 | |
Finance lease liabilities, net of current portion | |
| - | | |
| - | |
Total finance lease liabilities | |
$ | 1 | | |
$ | 4 | |
| |
| | | |
| | |
Weighted average remaining lease term | |
| | | |
| | |
Operating leases | |
| 4.0 years | | |
| 4.3 years | |
Finance leases | |
| 0.1 years | | |
| 0.6 years | |
| |
| | | |
| | |
Weighted average discount rate | |
| | | |
| | |
Operating leases | |
| 8.0 | % | |
| 8.0 | % |
Finance leases | |
| 8.0 | % | |
| 8.0 | % |
As
of June 30, 2024, maturities of lease liabilities were as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | | |
Finance Leases | |
| |
(in thousands) | |
2024 (excluding the six months ended June 30, 2024) | |
$ | 246 | | |
$ | 1 | |
2025 | |
| 435 | | |
| - | |
2026 | |
| 450 | | |
| - | |
2027 | |
| 450 | | |
| - | |
2028 | |
| 251 | | |
| - | |
Total future minimum lease payments | |
| 1,832 | | |
| 1 | |
Less imputed interest | |
| (253 | ) | |
| - | |
Total | |
$ | 1,579 | | |
$ | 1 | |
Note
10 – 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 condensed consolidated
statement of operations. 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
Options
The
Company granted stock options to purchase 85,198 shares of common stock to employees during the three and six months ended June 30, 2024.
These stock options are being expensed over the respective vesting period, which is based on a service condition. The fair value of the
stock options granted during the three and six months ended June 30, 2024, was approximately $0.1 million.
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 six months ended June 30, 2024.
Schedule of Fair Value Assumptions
Assumptions for Option Grants | |
| |
Stock Price Volatility | |
| 70.34 | % |
Risk-Free Interest Rate | |
| 4.45 | % |
Expected Life (in years) | |
| 6.08 | |
Expected Dividend Yield | |
| - | % |
Stock-based
compensation expense related to stock options was approximately $28,000 and $169,000 for the three months ended June 30, 2024 and 2023,
respectively. For the three months ended June 30, 2024, approximately $27,000 and $2,000 are included in selling, general and administrative
expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations. Stock-based compensation expense for the three months ended June 30, 2024 consisted of $62,000 expense for shares
vested during the quarter, partially offset by a credit of $33,000 due to the reversal of expense related to an immaterial error associated
with the forfeiture of unvested options for employee terminations that occurred in prior fiscal periods. For the three months ended June
30, 2023, approximately $156,000 and $13,000 are included in selling, general and administrative expenses and research and development
expenses, respectively, on the accompanying condensed consolidated statement of operations.
Stock-based
compensation expense related to stock options was $11,000 and $349,000 for the six months ended June 30, 2024 and 2023, respectively.
For the six months ended June 30, 2024, approximately $8,000 and $3,000 are included in selling, general and administrative expenses
and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations. Stock-based compensation expense for the six months ended June 30, 2024 consisted of $120,000 expense for shares vested during
the quarter, partially offset by a credit of $109,000 due to the reversal of expense related to an immaterial error associated with the
forfeiture of unvested options for employee terminations that occurred in prior fiscal periods. For the six months ended June 30, 2023,
approximately $315,000 and $34,000 are included in selling, general and administrative expenses and research and development expenses,
respectively, on the accompanying condensed consolidated statement of operations.
There
was no tax benefit related to expense recognized in the three or six months ended June 30, 2024 and 2023, as the Company is in a net
operating loss position. As of June 30, 2024, there was approximately $625,000 of total unrecognized compensation expense related to
unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining
requisite service period of 2.7 years.
Restricted
Stock
Total
stock-based compensation expense for restricted stock on the Company’s condensed consolidated statement of operations was approximately
$7,000 and $25,000 for the three months ended June 30, 2024 and 2023, respectively. Stock-based compensation expense for restricted stock
is included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations.
Total
stock-based compensation expense for restricted stock was approximately $ and $38,000 for the six months ended June 30, 2024, and
2023, respectively. During the six months ended June 30, 2023, 23,781 shares of restricted stock were issued to employees, 133,722 shares
of restricted stock were issued to board members all related to services rendered during the year ended December 31, 2022. In addition,
30,000 shares of restricted stock were issued to contractors during the six months ended June 30, 2023. All restricted shares issued
during the six months ended June 30, 2023, have a vesting period of six months.
As
of June 30, 2024, there was no unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation
plans.
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 acquisition of the non-controlling interest in SRP during the six months ended June 30, 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 six months ended June 30, 2023. For the six months ended June 30, 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 equity-based awards
is included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations.
Note
11 – Stockholders’ Equity
Noncontrolling
Interest
In
separate transactions in September 2018 and February 2022, SRP issued and sold an aggregate of 700,003 shares of its Series A Preferred
Stock for aggregate gross proceeds of approximately $3.5 million. Of such shares, the Company purchased 62,500 shares in the February
2022 transaction, maintaining a 62.5% ownership stake in SRP. Approximately $188,000 of the proceeds from the February 2022 sales were
recorded as an increase to the equity of the non-controlling interests. In addition to the Company’s purchase of Series A Preferred
Stock from SRP, the Company also loaned to SRP the principal amount of $1.3 million, $1.0 million of which was advanced during the year
ended December 31, 2020.
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.
Note
12 – 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:
Schedule
of Antidilutive Securities Excluded from Computation of Earnings Per Share
| |
June 30, | |
| |
2024 | | |
2023 | |
Shares underlying options outstanding | |
| 1,249,354 | | |
| 1,765,853 | |
Unvested restricted stock | |
| - | | |
| 187,503 | |
Note
13 – Commitments and Contingencies
Purchase
Commitments
In
exchange for the rights granted under the License and Supply Agreement with Medica (see Note 7 – 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, 2024, the Company has agreed to make minimum annual aggregate purchases from Medica of €4.2 million
(approximately $4.5 million). As of June 30, 2024, the Company’s aggregate purchase commitments totaled €3.6 million (approximately
$3.9 million).
Contractual
Obligations
See
Note 9 – Leases for a discussion of the Company’s contractual obligations.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion should be read in conjunction with our condensed consolidated 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
We
are a commercial-stage company that develops and sells high performance water solutions to the medical and commercial markets.
Our
medical water filters, mostly classified as ultrafilters, are used primarily by 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. Because our ultrafilters capture contaminants as small as 0.005 microns in size, they minimize exposure to a wide variety
of bacteria, viruses, fungi, parasites, and endotoxins.
Our
commercial water filters improve the taste and odor of water and reduce biofilm, cysts, particulates, and scale build-up in downstream
equipment. Our products are marketed primarily to the food service, hospitality, convenience store, and health care markets, and also
sold to medical institutions to supplement our medical filters.
We
previously held a majority stake in Specialty Renal Products, Inc. (“SRP”), a development-stage medical device company that
was focused primarily on developing hemodiafiltration (“HDF”) technology. In May 2022, SRP received 510(k) clearance from
the FDA for SRP’s second-generation model of the OLpūrH2H Hemodiafiltration System, which enables nephrologists to provide
HDF treatment to patients with end stage renal disease. In January 2023, SRP management began exploring strategic partnerships to support
a commercial launch of the HDF product but was unsuccessful in identifying a partner. By late February 2023, SRP had nearly exhausted
its capital resources and, due to its limited capital and lack of prospects for securing a strategic partnership or additional financing,
the board of directors of SRP adopted a plan on March 6, 2023 to wind down SRP operations, liquidate its remaining assets and dissolve
the company. That plan was approved by SRP’s stockholders on March 9, 2023, and on April 13, 2023, SRP filed a certificate of dissolution
with the State of Delaware. SRP’s cash resources were sufficient to satisfy all of its outstanding liabilities other than its obligations
to us under a loan with an outstanding balance of approximately $1.5 million. Accordingly, SRP assigned to Nephros all of its remaining
assets, including its intellectual property rights in the HDF2 device, in satisfaction of its outstanding loan balance. Although we have
no current plans to do so, we may re-evaluate opportunities for HDF in the future.
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 value-added resellers (“VARs”). Leveraging VARs has enabled
us to expand rapidly 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
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 signed an agreement with a partner to be the exclusive
distributor to resell select water filters and related products to customers in the commercial food and beverage markets subject to meeting
certain minimum thresholds.
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. |
|
● |
Military and Outdoor Recreation:
Individual water purification devices used by soldiers and backpackers to produce drinking water in the field, as well as filters
customized to remote water processing systems. |
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. 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” configurations. |
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 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 this commercial partner, which superseded the March 2022 agreement. Under
the January 2023 agreement, we engaged this commercial partner to be our exclusive distributor to the food, beverage and hospitality
industries. We continue 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, 2024, 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, 2023.
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 Condensed Consolidated
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 progress 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, 2024 Compared to the Three Months Ended June 30, 2023
The
following table sets forth our summarized, consolidated results of operations for the three months ended June 30, 2024 and 2023 (in thousands,
except percentages):
| |
| | |
| | |
$ | | |
% | |
| |
| | |
| | |
Increase | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | | |
(Decrease) | |
Total net revenues | |
$ | 3,252 | | |
$ | 3,545 | | |
$ | (293 | ) | |
| (8 | )% |
Cost of goods sold | |
| 1,340 | | |
| 1,466 | | |
| (126 | ) | |
| (9 | )% |
Gross margin | |
| 1,912 | | |
| 2,079 | | |
| (167 | ) | |
| (8 | )% |
Gross margin % | |
| 59 | % | |
| 59 | % | |
| - | | |
| - | % |
Selling, general and administrative expense | |
| 1,941 | | |
| 2,239 | | |
| (298 | ) | |
| (13 | )% |
Research and development expense | |
| 254 | | |
| 221 | | |
| 33 | | |
| 15 | % |
Depreciation and amortization expense | |
| 34 | | |
| 54 | | |
| (20 | ) | |
| (37 | )% |
Operating loss | |
| (317 | ) | |
| (435 | ) | |
| 118 | | |
| (27 | )% |
Interest expense | |
| - | | |
| - | | |
| - | | |
| - | % |
Interest income | |
| 21 | | |
| 13 | | |
| 8 | | |
| 62 | % |
Other income (expense), net | |
| 7 | | |
| (11 | ) | |
| 18 | | |
| 164 | % |
Net loss | |
$ | (289 | ) | |
$ | (433 | ) | |
$ | 144 | | |
| (33 | )% |
Revenue
Overall,
net revenues decreased by $0.3 million, or 8%, for the three months ended June 30, 2024, compared to the same period in 2023. This decrease
was primarily driven by decreased revenue from emergency response orders, which were unusually large in the second quarter of 2023 but
not repeated to the same degree in the comparable 2024 period. We believe that one contributor to this decline is the reduced stringency
of waterborne risk response in territories previously committed to both proactive filtration measures and robust corrective actions.
Consequently, we experienced the effects of a relaxation of requirements for emergency relief and remediation. However, the decrease
in emergency response orders was partially offset by increased revenue from programmatic or recurring sales, which were 8% more than
the same period in 2023. This increase in programmatic sales was due to the development of our newer sales personnel hired in 2023.
Gross
Profit Margin
Consolidated
gross margin was approximately 59% for each of the three month periods ended June 30, 2024, and June 30, 2023.
Selling,
General and Administrative Expenses
Consolidated
selling, general and administrative expenses decreased $298,000, or 13%, primarily due to
a decrease in bonus accrual, sales commission expense, stock compensation expense, and professional fees.
Research
and Development Expenses
Consolidated
research and development expenses increased approximately $33,000 due to an increase in headcount.
Depreciation
and Amortization Expense
Depreciation
and amortization expenses were approximately $34,000 and $54,000, respectively, for the three months ended June 30, 2024, and 2023.
Interest
Income
Interest
income was approximately $21,000 for the three months ended June 30, 2024 compared to approximately $13,000 for the three months ended
June 30, 2023.
Other
Income (Expense), net
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.
Other expense of approximately $11,000 for the three months ended June 30, 2023 is primarily a result of losses on foreign currency transactions.
Six
Months Ended June 30, 2024 Compared to the Six Months Ended June 30, 2023
The
following table sets forth our summarized, consolidated results of operations for the six months ended June 30, 2024 and 2023 (in thousands,
except percentages):
| |
| | |
| | |
$ | | |
% | |
| |
| | |
| | |
Increase | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | | |
(Decrease) | |
Total net revenues | |
$ | 6,774 | | |
$ | 7,242 | | |
$ | (468 | ) | |
| (6 | )% |
Cost of goods sold | |
| 2,675 | | |
| 3,052 | | |
| (377 | ) | |
| (12 | )% |
Gross margin | |
| 4,099 | | |
| 4,190 | | |
| (91 | ) | |
| (2 | )% |
Gross margin % | |
| 61 | % | |
| 58 | % | |
| - | | |
| 3 | % |
Selling, general and administrative expense | |
| 4,083 | | |
| 4,363 | | |
| (280 | ) | |
| (6 | )% |
Research and development expense | |
| 466 | | |
| 460 | | |
| 6 | | |
| 1 | % |
Depreciation and amortization expense | |
| 67 | | |
| 108 | | |
| (41 | ) | |
| (38 | )% |
Operating loss | |
| (517 | ) | |
| (741 | ) | |
| 224 | | |
| (30 | )% |
Interest expense | |
| (1 | ) | |
| (1 | ) | |
| - | | |
| - | % |
Interest income | |
| 46 | | |
| 25 | | |
| 21 | | |
| 84 | % |
Other (expense) income, net | |
| 14 | | |
| (22 | ) | |
| 36 | | |
| 164 | % |
Net loss | |
$ | (458 | ) | |
$ | (739 | ) | |
$ | 281 | | |
| (38 | )% |
Revenue
Overall,
net revenues decreased by $0.5 million, or 6% for the six months ended June 30, 2024, compared to the same period in 2023. This decrease
was primarily driven by decreased revenue from emergency response orders, which were unusually large in the first half of 2023 but not
repeated to the same degree in the comparable 2024 period. We believe that one contributor to this decline is the reduced stringency
of waterborne risk response in territories previously committed to both proactive filtration measures and robust corrective actions.
Consequently, we experienced the effects of a relaxation of requirements for emergency relief and remediation. However, the decrease
in emergency response orders was partially offset by increased revenue from programmatic or recurring sales, which were 10% more than
the same period in 2023. This increase in programmatic sales was due to the development of our newer sales personnel hired in 2023.
Gross
Profit Margin
Consolidated
gross margin was approximately 61% for the six months ended June 30, 2024, compared to approximately 58% for the six months ended June
30, 2023. The increase of approximately 3 percentage points, was driven by more favorable pricing terms with our largest supplier and
reduced shipping expenses in the first quarter of 2024.
Selling,
General and Administrative Expenses
Consolidated
selling, general and administrative expenses decreased $280,000 or 6% primarily due to a decrease in bonus accrual, sales commission
expense, stock compensation expense, and professional fees offset in part by an increase in salary expense.
Research
and Development Expenses
Consolidated
research and development expenses increased $6,000 primarily due to an increase in headcount offset by the wind down of our SRP division.
Depreciation
and Amortization Expense
Depreciation
and amortization expenses were approximately $67,000 and $108,000, respectively, for the six months ended June 30, 2024, and 2023.
Interest
Expense
Interest
expense was approximately $1,000 for the six months ended June 30, 2024 and June 30, 2023.
Interest
Income
Interest
income was approximately $46,000 for the six months ended June 30, 2024 compared to approximately $25,000 for the six months ended June
31, 2023.
Other
Income (Expense), net
Other
income was approximately $14,000 for the six months ended June 30, 2024, and is primarily a result
of losses on foreign currency transactions and a sale of a fully depreciated asset. Other expense was approximately $22,000 for
the six months ended June 30, 2023 and is primarily a result of losses on foreign currency transactions.
Liquidity
and Capital Resources
The
following table summarizes our liquidity and capital resources as of June 30, 2024 and December 31, 2023 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 | |
2024 | | |
2023 | |
Cash and cash equivalents | |
$ | 3,080 | | |
$ | 4,307 | |
Other current assets | |
| 4,846 | | |
| 4,098 | |
Working capital | |
| 5,974 | | |
| 6,292 | |
Stockholders’ equity | |
| 7,926 | | |
| 8,358 | |
At
June 30, 2024, we had an accumulated deficit of $144.9 million and we may incur additional operating losses from operations until such
time, if ever, that we are able to increase product sales and/or licensing revenue to achieve profitability.
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 condensed consolidated financial statements in this Quarterly Report on Form 10-Q. Additionally, our operating plans are designed
to help control operating costs, to increase revenue, and to raise additional capital until such time as we 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 used in operating activities was $1.2 million for the six months ended June 30, 2024, compared to net cash provided by operating
activities of approximately $0.5 million for the six months ended June 30, 2023. 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. Net cash provided
by operating activities in 2023 was primarily due to a decline in inventory of approximately $0.9 million, an increase in accrued expenses
of approximately $0.3 million offset by a decrease in accounts payable of approximately $0.4 million and an increase in accounts receivable
of approximately $0.3 million.
Net
cash used in investing activities was approximately $55,000 in the six months ended June 30, 2024, due to purchases of property and equipment.
We had no investing activities for the six months ended June 30, 2023.
Net
cash used in financing activities was approximately $4,000 for the six months ended June 30, 2024, primarily due to payments on finance
lease. Net cash used in financing activities was approximately $0.1 million for the six months ended June 30, 2023, primarily due to
principal payments on debt.
Off-Balance
Sheet Arrangements
We
did not have any off-balance sheet arrangements as of June 30, 2024.
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 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, 2023 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.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
required for smaller reporting companies.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
maintain a system of disclosure controls and procedures, as defined in Rule 13a-15(e) or Rule 15d-15(e) under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), which is designed to provide reasonable assurance that information required
to be disclosed in our reports filed pursuant to the Exchange Act is accumulated and communicated to management in a timely manner. Management
recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance
of achieving their objectives. Because there are inherent limitations in all control systems, no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud have been or will be detected.
At
the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the
participation of our management, including our Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of our
disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Chief Executive Officer and
Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were
effective.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1A. Risk Factors
As
a smaller reporting company, we are not required to provide disclosure pursuant to this item. However, in addition to other information
set forth in this Quarterly Report on Form 10-Q, including the important information in the section entitled “Forward Looking Statements,”
you should carefully consider the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December
31, 2023 for a discussion of important factors that could cause actual results to differ materially from the results described in or
implied by the forward-looking statements contained in this Quarterly Report on Form 10-Q. Additional risks and uncertainties not currently
known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or
operating results.
Item
5. Other Information.
During
the three months ended June 30, 2024, none of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement”
or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
Item
6. Exhibits
EXHIBIT
INDEX
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
NEPHROS, INC. |
|
|
|
Date: August 8, 2024 |
By: |
/s/ Robert
Banks |
|
Name: |
Robert Banks |
|
Title: |
President, Chief Executive Officer (Principal Executive
Officer) |
|
|
|
Date: August 8, 2024 |
By: |
/s/ Judy
Krandel |
|
Name: |
Judy Krandel |
|
Title: |
Chief Financial Officer (Principal Financial and Accounting
Officer) |
Exhibit
31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
UNDER
SECTION 302 OF THE SARBANES-OXLEY ACT
I,
Robert Banks, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Nephros, Inc.
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: August
8, 2024 |
By: |
/s/
Robert Banks |
|
Name: |
Robert Banks |
|
Title: |
President, Chief Executive Officer (Principal Executive
Officer) |
Exhibit
31.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
UNDER
SECTION 302 OF THE SARBANES-OXLEY ACT
I,
Judy Krandel, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Nephros, Inc.
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: August
8, 2024 |
By: |
/s/
Judy Krandel |
|
Name: |
Judy Krandel |
|
Title: |
Chief Financial Officer (Principal Financial and Accounting
Officer) |
Exhibit
32.1
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In
connection with the Quarterly Report on Form 10-Q of Nephros, Inc. (the “Company”) for the period ended June 30, 2024 as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Robert Banks, President, Chief Executive Officer of the Company,
certifies that:
1. |
the Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
2. |
the information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
By: |
/s/
Robert Banks |
|
Name: |
Robert Banks |
|
Title: |
President, Chief Executive Officer (Principal Executive
Officer) |
|
|
|
|
Dated: August 8, 2024 |
Exhibit
32.2
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In
connection with the Quarterly Report on Form 10-Q of Nephros, Inc. (the “Company”) for the period ended June 30, 2024 as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Judy Krandel, Chief Financial Officer of the Company, certifies
that:
1. |
the Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
2. |
the information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
By: |
/s/
Judy Krandel |
|
Name: |
Judy Krandel |
|
Title: |
Chief Financial Officer (Principal Financial and Accounting
Officer) |
|
|
|
|
Date: |
August 8, 2024 |
|
v3.24.2.u1
Cover - $ / shares
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6 Months Ended |
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Jun. 30, 2024 |
Aug. 05, 2024 |
Cover [Abstract] |
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Current Fiscal Year End Date |
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|
|
Entity File Number |
001-32288
|
|
Entity Registrant Name |
NEPHROS,
INC.
|
|
Entity Central Index Key |
0001196298
|
|
Entity Tax Identification Number |
13-3971809
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Entity Incorporation, State or Country Code |
DE
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380
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07079
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City Area Code |
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Local Phone Number |
343-5202
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Title of 12(b) Security |
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NEPH
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NASDAQ
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 3,080
|
$ 4,307
|
Accounts receivable, net |
1,878
|
1,496
|
Inventory |
2,803
|
2,470
|
Prepaid expenses and other current assets |
165
|
132
|
Total current assets |
7,926
|
8,405
|
Property and equipment, net |
186
|
152
|
Lease right-of-use assets |
1,551
|
1,807
|
Intangible assets, net |
365
|
381
|
Goodwill |
759
|
759
|
License and supply agreement, net |
243
|
271
|
Other assets |
70
|
86
|
TOTAL ASSETS |
11,100
|
11,861
|
Current liabilities: |
|
|
Accounts payable |
1,159
|
873
|
Accrued expenses |
435
|
794
|
Current portion of lease liabilities |
358
|
446
|
Total current liabilities |
1,952
|
2,113
|
Lease liabilities, net of current portion |
1,222
|
1,390
|
TOTAL LIABILITIES |
3,174
|
3,503
|
COMMITMENTS AND CONTINGENCIES (Note 13) |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, $.001 par value; 5,000,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023. |
|
|
Common stock, $.001 par value; 40,000,000 shares authorized at June 30, 2024 and December 31, 2023; 10,544,139 and 10,543,675 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively. |
11
|
10
|
Additional paid-in capital |
152,779
|
152,754
|
Accumulated deficit |
(144,864)
|
(144,406)
|
TOTAL STOCKHOLDERS’ EQUITY |
7,926
|
8,358
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 11,100
|
$ 11,861
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
40,000,000
|
40,000,000
|
Common stock, shares issued |
10,544,139
|
10,543,675
|
Common stock, shares outstanding |
10,544,139
|
10,543,675
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Net revenue: |
|
|
|
|
Total net revenues |
$ 3,252
|
$ 3,545
|
$ 6,774
|
$ 7,242
|
Cost of goods sold |
1,340
|
1,466
|
2,675
|
3,052
|
Gross margin |
1,912
|
2,079
|
4,099
|
4,190
|
Operating expenses: |
|
|
|
|
Selling, general and administrative |
1,941
|
2,239
|
4,083
|
4,363
|
Research and development |
254
|
221
|
466
|
460
|
Depreciation and amortization |
34
|
54
|
67
|
108
|
Total operating expenses |
2,229
|
2,514
|
4,616
|
4,931
|
Operating loss |
(317)
|
(435)
|
(517)
|
(741)
|
Other (expense) income: |
|
|
|
|
Interest expense |
|
|
(1)
|
(1)
|
Interest income |
21
|
13
|
46
|
25
|
Other income (expense), net |
7
|
(11)
|
14
|
(22)
|
Total other expense: |
28
|
2
|
59
|
2
|
Net loss |
$ (289)
|
$ (433)
|
$ (458)
|
$ (739)
|
Net loss per common share, basic |
$ (0.03)
|
$ (0.04)
|
$ (0.04)
|
$ (0.07)
|
Net loss per common share, diluted |
$ (0.03)
|
$ (0.04)
|
$ (0.04)
|
$ (0.07)
|
Weighted average common shares outstanding, basic |
10,509,937
|
10,297,429
|
10,505,833
|
10,297,429
|
Weighted average common shares outstanding, diluted |
10,509,937
|
10,297,429
|
10,505,833
|
10,297,429
|
Product [Member] |
|
|
|
|
Net revenue: |
|
|
|
|
Total net revenues |
$ 3,208
|
$ 3,537
|
$ 6,714
|
$ 7,199
|
Royalty and Other Revenues [Member] |
|
|
|
|
Net revenue: |
|
|
|
|
Total net revenues |
$ 44
|
$ 8
|
$ 60
|
$ 43
|
X |
- DefinitionThe aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities.
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v3.24.2.u1
Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Parent [Member] |
Noncontrolling Interest [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 10
|
$ 148,413
|
$ (142,831)
|
$ 5,592
|
$ 3,289
|
$ 8,881
|
Balance, shares at Dec. 31, 2022 |
10,297,429
|
|
|
|
|
|
Net loss |
|
|
(306)
|
(306)
|
|
(306)
|
Stock-based compensation |
|
346
|
|
346
|
(27)
|
319
|
Change in non-controlling interest |
|
3,262
|
|
3,262
|
(3,262)
|
|
Balance at Mar. 31, 2023 |
$ 10
|
152,021
|
(143,137)
|
8,894
|
|
8,894
|
Balance, shares at Mar. 31, 2023 |
10,297,429
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 10
|
148,413
|
(142,831)
|
5,592
|
3,289
|
8,881
|
Balance, shares at Dec. 31, 2022 |
10,297,429
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(739)
|
Balance at Jun. 30, 2023 |
$ 10
|
152,215
|
(143,570)
|
8,655
|
|
8,655
|
Balance, shares at Jun. 30, 2023 |
10,297,429
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 10
|
152,021
|
(143,137)
|
8,894
|
|
8,894
|
Balance, shares at Mar. 31, 2023 |
10,297,429
|
|
|
|
|
|
Net loss |
|
|
(433)
|
(433)
|
|
(433)
|
Stock-based compensation |
|
194
|
|
194
|
|
194
|
Balance at Jun. 30, 2023 |
$ 10
|
152,215
|
(143,570)
|
8,655
|
|
8,655
|
Balance, shares at Jun. 30, 2023 |
10,297,429
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 10
|
152,754
|
(144,406)
|
8,358
|
|
8,358
|
Balance, shares at Dec. 31, 2023 |
10,501,508
|
|
|
|
|
|
Net loss |
|
|
(169)
|
(169)
|
|
(169)
|
Stock option exercises |
|
|
|
|
|
|
Balance, shares |
464
|
|
|
|
|
|
Stock-based compensation |
|
(9)
|
|
(9)
|
|
(9)
|
Balance at Mar. 31, 2024 |
$ 10
|
152,745
|
(144,575)
|
8,180
|
|
8,180
|
Balance, shares at Mar. 31, 2024 |
10,501,972
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 10
|
152,754
|
(144,406)
|
8,358
|
|
8,358
|
Balance, shares at Dec. 31, 2023 |
10,501,508
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(458)
|
Balance at Jun. 30, 2024 |
$ 11
|
152,779
|
(144,864)
|
7,926
|
|
7,926
|
Balance, shares at Jun. 30, 2024 |
10,544,139
|
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 10
|
152,745
|
(144,575)
|
8,180
|
|
8,180
|
Balance, shares at Mar. 31, 2024 |
10,501,972
|
|
|
|
|
|
Net loss |
|
|
(289)
|
(289)
|
|
(289)
|
Stock-based compensation |
|
35
|
|
35
|
|
35
|
Restricted stock vesting |
$ 1
|
(1)
|
|
|
|
|
Balance, shares |
42,167
|
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 11
|
$ 152,779
|
$ (144,864)
|
$ 7,926
|
|
$ 7,926
|
Balance, shares at Jun. 30, 2024 |
10,544,139
|
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
Net loss |
$ (289)
|
$ (169)
|
$ (433)
|
$ (306)
|
$ (458)
|
$ (739)
|
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
Depreciation of property and equipment |
|
|
|
|
22
|
19
|
|
Amortization of intangible assets, license and supply agreement and finance lease right-of-use asset |
|
|
|
|
47
|
88
|
|
Stock-based compensation |
|
|
|
|
26
|
513
|
|
Inventory impairments and writeoffs |
|
|
|
|
180
|
106
|
|
Gain on foreign currency transactions |
|
|
|
|
(5)
|
|
|
Gain on disposal of equipment |
|
|
|
|
(5)
|
|
|
Decrease (increase) in operating assets: |
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
(382)
|
(290)
|
|
Inventory |
|
|
|
|
(513)
|
920
|
|
Prepaid expenses and other current assets |
|
|
|
|
(33)
|
35
|
|
Right-of-use assets |
|
|
|
|
252
|
160
|
|
Other assets |
|
|
|
|
17
|
2
|
|
(Decrease) increase in operating liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
289
|
(437)
|
|
Accrued expenses |
|
|
|
|
(358)
|
285
|
|
Lease liabilities |
|
|
|
|
(252)
|
(160)
|
|
Net cash (used in) provided by operating activities |
|
|
|
|
(1,173)
|
502
|
$ 800
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
Proceeds from sale of equipment |
|
|
|
|
5
|
|
|
Purchase of property and equipment |
|
|
|
|
(55)
|
|
|
Net cash used in investing activities |
|
|
|
|
(50)
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
Principal payments on finance lease liability |
|
|
|
|
(4)
|
(4)
|
|
Principal payments on equipment financing |
|
|
|
|
|
(1)
|
|
Payments on secured note payable |
|
|
|
|
|
(71)
|
|
Net cash (used in) financing activities |
|
|
|
|
(4)
|
(76)
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
|
|
(1,227)
|
426
|
|
Cash and cash equivalents, beginning of period |
|
$ 4,307
|
|
$ 3,634
|
4,307
|
3,634
|
3,634
|
Cash and cash equivalents, end of period |
$ 3,080
|
|
$ 4,060
|
|
3,080
|
4,060
|
$ 4,307
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
Cash paid for interest |
|
|
|
|
$ 1
|
$ 2
|
|
X |
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
|
|
Net Income (Loss) |
$ (289)
|
$ (169)
|
$ (433)
|
$ (306)
|
$ (458)
|
$ (739)
|
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v3.24.2.u1
Organization and Nature of Operations
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Nature of Operations |
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.
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, and 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.
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v3.24.2.u1
Basis of Presentation and Liquidity
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation and Liquidity |
Note
2 – Basis of Presentation and Liquidity
Interim
Financial Information
The
accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting
principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 and Article 10
of Regulation S-X. The condensed consolidated balance sheet as of December 31, 2023 was derived from the Company’s audited financial
statements. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. Results
as of and for the six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024.
The
condensed consolidated interim financial statements and notes thereto should be read in conjunction with the consolidated financial statements
and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
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.
Consolidation
The
accompanying condensed consolidated financial statements include the accounts of Nephros, Inc. and its subsidiary, 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
condensed consolidated financial statements.
Use
of Estimates
The
preparation of consolidated financial statements in conformity with 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.
Liquidity
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. See “Note 11
– Stockholders’ Equity – Noncontrolling Interest” Accordingly, as of June 30, 2024, there was no outstanding
balance of this loan.
The
Company has sustained operating losses every quarter through June 30, 2024, generating an accumulated deficit of $144.9 million as of
June 30, 2024. However, in 2023, the Company’s operating cash flow was positive due to increased sales, improved gross margins,
careful expense management, a reduction in inventory, and the dispositions of the Pathogen Detection Systems and SRP businesses. These
actions resulted in the Company generating cash from operations of approximately $0.8 million for the twelve months ended December 31,
2023. Conversely, net cash from operations was negative for the six months ended June 30, 2024 due to an operating loss, payment of prior
year annual bonuses, and an increase in inventory and accounts receivable. The Company continues to focus on growth in sales and managing
tight expenses with the goal of turning cash flow positive from operations. The investment in inventory in the first quarter of 2024 was preparing
for higher volumes of key products in the future. The Company believes that the tight focus on operations and its current 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 condensed
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.
Recent
Accounting Pronouncements, Not Yet Effective
In
March 2024, the FASB issued ASU 2024-01, “ASC 718-Scope Application of Profits Interest and Similar Awards,” which provides
guidance to assist entities in determining whether profits interest and similar awards should be accounted for in accordance with Topic
718, Compensation—Stock Compensation. The guidance is effective for the Company’s fiscal year 2025, including interim periods.
Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its condensed consolidated financial statements.
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 condensed 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.
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 three months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Schedule of Revenues and Accounts Receivable Percentage of Major Customers
Customer | |
2024 | | |
2023 | |
A | |
| 22 | % | |
| 18 | % |
B | |
| 8 | % | |
| 11 | % |
D | |
| 3 | % | |
| 11 | % |
Total | |
| 33 | % | |
| 40 | % |
For
the six months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 27 | % | |
| 19 | % |
B | |
| 7 | % | |
| 10 | % |
C | |
| 2 | % | |
| 13 | % |
Total | |
| 36 | % | |
| 42 | % |
As
of June 30, 2024, and December 31, 2023, the following customers accounted for the following percentages of the Company’s accounts
receivable, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 16 | % | |
| 12 | % |
E | |
| 12 | % | |
| - | |
Total | |
| 28 | % | |
| 12 | % |
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 doubtful accounts 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 credit losses was approximately $11,000 as of each of the
periods ended June 30, 2024, and December 31, 2023.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.2.u1
Revenue Recognition
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
Revenue Recognition |
Note
3 – 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 for the three and
six months ended June 30, 2024, or 2023. In addition to product revenue, the Company recognizes revenue related to services to customers,
royalties, and other agreements in accordance with the five-step model in ASC 606. Other revenues recognized for the three and six months
ended June 30, 2024, were approximately $44,000 and $60,000, respectively. Other revenues recognized for the three and six months ended
June 30, 2023 were approximately $8,000 and $43,000, respectively.
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v3.24.2.u1
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
Note
4 – 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.
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
June 30, 2024 the Company’s cash equivalents consisted of money market funds. At December 31,2023 the Company’s cash equivalents
consisted of money market funds and a certificate of deposit. 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
June 30, 2024 and December 31, 2023, the fair value measurements of the Company’s assets and liabilities measured on a recurring
basis were as follows:
Schedule
of Assets and Liabilities Measured at Fair Value on Recurring Basis
(in thousands) | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | | |
Significant Other Observable Inputs (Level 2) | | |
Significant Unobservable Inputs (Level 3) | |
| |
| |
June 30, 2024 | |
| | | |
| | | |
| | |
Cash | |
$ | 1,403 | | |
$ | - | | |
$ | - | |
Money market funds | |
| 1,677 | | |
| - | | |
| - | |
| |
| - | | |
| | | |
| | |
Cash and cash equivalents | |
$ | 3,080 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Cash | |
$ | 274 | | |
$ | - | | |
$ | - | |
Money market funds | |
| 2,515 | | |
| - | | |
| - | |
Certificate of deposit | |
| 1,518 | | |
| - | | |
| - | |
Cash and cash equivalents | |
$ | 4,307 | | |
$ | - | | |
$ | - | |
Assets
and Liabilities Not Measured at Fair Value on a Recurring Basis
The
carrying amounts of accounts receivable, accounts payable and accrued expenses approximate fair value due to their short-term nature.
The
carrying amounts of the lease liabilities and equipment financing approximate fair value as of June 30, 2024 and December 31, 2023 because
those financial instruments bear interest at rates that approximate current market rates for similar agreements with similar maturities
and quality.
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v3.24.2.u1
Inventory
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Inventory |
Note
5 – 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 June 30, 2024 and December 31, 2023, were as follows:
Schedule
of Inventory, Net
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(in thousands) | |
Finished goods | |
$ | 2,413 | | |
$ | 2,144 | |
Raw materials | |
| 390 | | |
| 326 | |
Total inventory | |
$ | 2,803 | | |
$ | 2,470 | |
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v3.24.2.u1
Intangible Assets and Goodwill
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets and Goodwill |
Note
6 – Intangible Assets and Goodwill
Intangible
Assets
Intangible
assets as of June 30, 2024 and December 31, 2023 are set forth in the table below. Gross carrying values and accumulated amortization
of the Company’s intangible assets by type are as follows:
Schedule
of Intangible Assets
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Cost | | |
Accumulated Amortization | | |
Net | | |
Cost | | |
Accumulated Amortization | | |
Net | |
| |
(in thousands) | |
Customer relationships | |
$ | 540 | | |
| (175 | ) | |
$ | 365 | | |
$ | 540 | | |
| (159 | ) | |
| 381 | |
Total intangible assets | |
$ | 540 | | |
$ | (175 | ) | |
$ | 365 | | |
$ | 540 | | |
$ | (159 | ) | |
$ | 381 | |
The
Company recognized amortization expense of approximately $8,000 and $11,000 for the three months ended June 30, 2024 and June 30, 2023,
respectively. All were recognized in selling, general and administrative expenses on the accompanying condensed consolidated statement
of operations.
As
of June 30, 2024, future amortization expense for each of the next five years is (in thousands):
Schedule
of Future Amortization Expense
Fiscal Years | |
| |
2024 (excluding the six months ended June 30, 2024) | |
$ | 16 | |
2025 | |
| 32 | |
2026 | |
| 32 | |
2027 | |
| 32 | |
2028 | |
| 32 | |
2029 | |
| 32 | |
Goodwill
Goodwill
has a carrying value on the Company’s condensed consolidated balance sheets of approximately $0.8 million at June 30, 2024 and
December 31, 2023.
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v3.24.2.u1
License and Supply Agreement, net
|
6 Months Ended |
Jun. 30, 2024 |
License And Supply Agreement Net |
|
License and Supply Agreement, net |
Note
7 – 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 to 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 includes 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 condensed consolidated balance sheet is $0.2 million and $0.3 million as of June 30, 2024 and December 31, 2023, respectively. Accumulated
amortization is $2.0 and $1.9 million as of June 30, 2024 and December 31, 2023, respectively. The intangible asset is being amortized
as an expense over the life of the License and Supply Agreement. Amortization expense of approximately $14,000 and $33,000 was recognized
in each of the three months ended June 30, 2024 and 2023, respectively on the condensed consolidated statement of operations.
As
of December 11, 2023, the Company has agreed with Medica 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 six months ended June 30, 2024 or June 30, 2023.
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. Approximately $95,000 for the three months ended June 30, 2023 was recognized as royalty expense and is included in cost of
goods sold on the condensed consolidated statement of operations. Approximately $191,000 for the six months ended
June 30, 2023 was recognized as royalty expense and is included in cost of goods sold on the condensed consolidated statement of operations. Approximately $95,000 of this royalty expense was included in accounts payable as of June 30, 2023. Starting
in 2024, the Company is no longer required to pay Medica royalties.
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v3.24.2.u1
Secured Note Payable
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
Secured Note Payable |
Note
8 – 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. As of June 30, 2023, the principal balance of the Secured Note was paid off.
The
Secured Note had a maturity date of April 1, 2023. The unpaid principal balance accrued interest at a rate of 8% per annum. Principal
and interest payments were due on the first day of each month commencing on May 1, 2018. The Secured Note was subject to terms and conditions
of and was 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 was an event of default under the Secured Note and vice versa.
During
the three months ended June 30, 2023, no payments were made under the Secured Note, as the Note was repaid in full at March 31, 2023.
During
the six months ended June 30, 2023, the Company made payments under the Secured Note of approximately $71,000. Included in the total
payments made, approximately $1,000 was recognized as interest expense on the condensed consolidated statements of operations for the six months ended June 30, 2023.
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v3.24.2.u1
Leases
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
Leases |
Note
9 – Leases
The
Company has operating leases for corporate offices 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:
Schedule of Components of Lease Cost
| |
Three
months ended June 30, 2024 | | |
Three
months ended June 30, 2023 | |
| |
(in thousands) | |
Operating lease cost | |
$ | 127 | | |
$ | 90 | |
Finance lease cost: | |
| | | |
| | |
Amortization of right-of-use assets | |
| 2 | | |
| 2 | |
Interest on lease liabilities | |
| 1 | | |
| 1 | |
Total finance lease cost | |
| 3 | | |
| 3 | |
Variable lease cost | |
| 14 | | |
| 3 | |
Total lease cost | |
$ | 144 | | |
$ | 96 | |
| |
Six months ended June 30, 2024 | | |
Six months ended June 30, 2023 | |
| |
(in thousands) | |
Operating lease cost | |
$ | 252 | | |
$ | 182 | |
Finance lease cost: | |
| | | |
| | |
Amortization of right-of-use assets | |
| 4 | | |
| 4 | |
Interest on lease liabilities | |
| 2 | | |
| 2 | |
Total finance lease cost | |
| 6 | | |
| 6 | |
Variable lease cost | |
| 25 | | |
| 7 | |
Total lease cost | |
$ | 283 | | |
$ | 195 | |
Supplemental
cash flow information related to leases was as follows:
Schedule of Supplemental Cash Flow Information Related to Leases
| |
Six months ended June 30, 2024 | | |
Six months ended June 30, 2023 | |
| |
(in thousands) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 316 | | |
$ | 160 | |
Financing cash flows from finance leases | |
$ | 4 | | |
$ | 4 | |
Supplemental
balance sheet information related to leases was as follows:
Schedule of Supplemental Balance Sheet Information Related to Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(in thousands) | |
Operating lease right-of-use assets | |
$ | 1,550 | | |
$ | 1,803 | |
Finance lease right-of-use assets | |
$ | 1 | | |
$ | 4 | |
| |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 357 | | |
$ | 442 | |
Operating lease liabilities, net of current portion | |
| 1,222 | | |
| 1,390 | |
Total operating lease liabilities | |
$ | 1,579 | | |
$ | 1,832 | |
| |
| | | |
| | |
Current portion of finance lease liabilities | |
$ | 1 | | |
$ | 4 | |
Finance lease liabilities, net of current portion | |
| - | | |
| - | |
Total finance lease liabilities | |
$ | 1 | | |
$ | 4 | |
| |
| | | |
| | |
Weighted average remaining lease term | |
| | | |
| | |
Operating leases | |
| 4.0 years | | |
| 4.3 years | |
Finance leases | |
| 0.1 years | | |
| 0.6 years | |
| |
| | | |
| | |
Weighted average discount rate | |
| | | |
| | |
Operating leases | |
| 8.0 | % | |
| 8.0 | % |
Finance leases | |
| 8.0 | % | |
| 8.0 | % |
As
of June 30, 2024, maturities of lease liabilities were as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | | |
Finance Leases | |
| |
(in thousands) | |
2024 (excluding the six months ended June 30, 2024) | |
$ | 246 | | |
$ | 1 | |
2025 | |
| 435 | | |
| - | |
2026 | |
| 450 | | |
| - | |
2027 | |
| 450 | | |
| - | |
2028 | |
| 251 | | |
| - | |
Total future minimum lease payments | |
| 1,832 | | |
| 1 | |
Less imputed interest | |
| (253 | ) | |
| - | |
Total | |
$ | 1,579 | | |
$ | 1 | |
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v3.24.2.u1
Stock Plans and Share-Based Payments
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Plans and Share-Based Payments |
Note
10 – 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 condensed consolidated
statement of operations. 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
Options
The
Company granted stock options to purchase 85,198 shares of common stock to employees during the three and six months ended June 30, 2024.
These stock options are being expensed over the respective vesting period, which is based on a service condition. The fair value of the
stock options granted during the three and six months ended June 30, 2024, was approximately $0.1 million.
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 six months ended June 30, 2024.
Schedule of Fair Value Assumptions
Assumptions for Option Grants | |
| |
Stock Price Volatility | |
| 70.34 | % |
Risk-Free Interest Rate | |
| 4.45 | % |
Expected Life (in years) | |
| 6.08 | |
Expected Dividend Yield | |
| - | % |
Stock-based
compensation expense related to stock options was approximately $28,000 and $169,000 for the three months ended June 30, 2024 and 2023,
respectively. For the three months ended June 30, 2024, approximately $27,000 and $2,000 are included in selling, general and administrative
expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations. Stock-based compensation expense for the three months ended June 30, 2024 consisted of $62,000 expense for shares
vested during the quarter, partially offset by a credit of $33,000 due to the reversal of expense related to an immaterial error associated
with the forfeiture of unvested options for employee terminations that occurred in prior fiscal periods. For the three months ended June
30, 2023, approximately $156,000 and $13,000 are included in selling, general and administrative expenses and research and development
expenses, respectively, on the accompanying condensed consolidated statement of operations.
Stock-based
compensation expense related to stock options was $11,000 and $349,000 for the six months ended June 30, 2024 and 2023, respectively.
For the six months ended June 30, 2024, approximately $8,000 and $3,000 are included in selling, general and administrative expenses
and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations. Stock-based compensation expense for the six months ended June 30, 2024 consisted of $120,000 expense for shares vested during
the quarter, partially offset by a credit of $109,000 due to the reversal of expense related to an immaterial error associated with the
forfeiture of unvested options for employee terminations that occurred in prior fiscal periods. For the six months ended June 30, 2023,
approximately $315,000 and $34,000 are included in selling, general and administrative expenses and research and development expenses,
respectively, on the accompanying condensed consolidated statement of operations.
There
was no tax benefit related to expense recognized in the three or six months ended June 30, 2024 and 2023, as the Company is in a net
operating loss position. As of June 30, 2024, there was approximately $625,000 of total unrecognized compensation expense related to
unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining
requisite service period of 2.7 years.
Restricted
Stock
Total
stock-based compensation expense for restricted stock on the Company’s condensed consolidated statement of operations was approximately
$7,000 and $25,000 for the three months ended June 30, 2024 and 2023, respectively. Stock-based compensation expense for restricted stock
is included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations.
Total
stock-based compensation expense for restricted stock was approximately $ and $38,000 for the six months ended June 30, 2024, and
2023, respectively. During the six months ended June 30, 2023, 23,781 shares of restricted stock were issued to employees, 133,722 shares
of restricted stock were issued to board members all related to services rendered during the year ended December 31, 2022. In addition,
30,000 shares of restricted stock were issued to contractors during the six months ended June 30, 2023. All restricted shares issued
during the six months ended June 30, 2023, have a vesting period of six months.
As
of June 30, 2024, there was no unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation
plans.
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 acquisition of the non-controlling interest in SRP during the six months ended June 30, 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 six months ended June 30, 2023. For the six months ended June 30, 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 equity-based awards
is included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations.
|
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Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
11 – Stockholders’ Equity
Noncontrolling
Interest
In
separate transactions in September 2018 and February 2022, SRP issued and sold an aggregate of 700,003 shares of its Series A Preferred
Stock for aggregate gross proceeds of approximately $3.5 million. Of such shares, the Company purchased 62,500 shares in the February
2022 transaction, maintaining a 62.5% ownership stake in SRP. Approximately $188,000 of the proceeds from the February 2022 sales were
recorded as an increase to the equity of the non-controlling interests. In addition to the Company’s purchase of Series A Preferred
Stock from SRP, the Company also loaned to SRP the principal amount of $1.3 million, $1.0 million of which was advanced during the year
ended December 31, 2020.
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.
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v3.24.2.u1
Net Loss per Common Share
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Net Loss per Common Share |
Note
12 – 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:
Schedule
of Antidilutive Securities Excluded from Computation of Earnings Per Share
| |
June 30, | |
| |
2024 | | |
2023 | |
Shares underlying options outstanding | |
| 1,249,354 | | |
| 1,765,853 | |
Unvested restricted stock | |
| - | | |
| 187,503 | |
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v3.24.2.u1
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note
13 – Commitments and Contingencies
Purchase
Commitments
In
exchange for the rights granted under the License and Supply Agreement with Medica (see Note 7 – 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, 2024, the Company has agreed to make minimum annual aggregate purchases from Medica of €4.2 million
(approximately $4.5 million). As of June 30, 2024, the Company’s aggregate purchase commitments totaled €3.6 million (approximately
$3.9 million).
Contractual
Obligations
See
Note 9 – Leases for a discussion of the Company’s contractual obligations.
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v3.24.2.u1
Basis of Presentation and Liquidity (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Interim Financial Information |
Interim
Financial Information
The
accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting
principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 and Article 10
of Regulation S-X. The condensed consolidated balance sheet as of December 31, 2023 was derived from the Company’s audited financial
statements. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. Results
as of and for the six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024.
The
condensed consolidated interim financial statements and notes thereto should be read in conjunction with the consolidated financial statements
and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
|
Segment Reporting |
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.
|
Consolidation |
Consolidation
The
accompanying condensed consolidated financial statements include the accounts of Nephros, Inc. and its subsidiary, 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
condensed consolidated financial statements.
|
Use of Estimates |
Use
of Estimates
The
preparation of consolidated financial statements in conformity with 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.
|
Liquidity |
Liquidity
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. See “Note 11
– Stockholders’ Equity – Noncontrolling Interest” Accordingly, as of June 30, 2024, there was no outstanding
balance of this loan.
The
Company has sustained operating losses every quarter through June 30, 2024, generating an accumulated deficit of $144.9 million as of
June 30, 2024. However, in 2023, the Company’s operating cash flow was positive due to increased sales, improved gross margins,
careful expense management, a reduction in inventory, and the dispositions of the Pathogen Detection Systems and SRP businesses. These
actions resulted in the Company generating cash from operations of approximately $0.8 million for the twelve months ended December 31,
2023. Conversely, net cash from operations was negative for the six months ended June 30, 2024 due to an operating loss, payment of prior
year annual bonuses, and an increase in inventory and accounts receivable. The Company continues to focus on growth in sales and managing
tight expenses with the goal of turning cash flow positive from operations. The investment in inventory in the first quarter of 2024 was preparing
for higher volumes of key products in the future. The Company believes that the tight focus on operations and its current 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 condensed
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.
|
Recent Accounting Pronouncements, Not Yet Effective |
Recent
Accounting Pronouncements, Not Yet Effective
In
March 2024, the FASB issued ASU 2024-01, “ASC 718-Scope Application of Profits Interest and Similar Awards,” which provides
guidance to assist entities in determining whether profits interest and similar awards should be accounted for in accordance with Topic
718, Compensation—Stock Compensation. The guidance is effective for the Company’s fiscal year 2025, including interim periods.
Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its condensed consolidated financial statements.
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 condensed 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.
|
Concentration of Credit Risk |
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 |
Major
Customers
For
the three months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Schedule of Revenues and Accounts Receivable Percentage of Major Customers
Customer | |
2024 | | |
2023 | |
A | |
| 22 | % | |
| 18 | % |
B | |
| 8 | % | |
| 11 | % |
D | |
| 3 | % | |
| 11 | % |
Total | |
| 33 | % | |
| 40 | % |
For
the six months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 27 | % | |
| 19 | % |
B | |
| 7 | % | |
| 10 | % |
C | |
| 2 | % | |
| 13 | % |
Total | |
| 36 | % | |
| 42 | % |
As
of June 30, 2024, and December 31, 2023, the following customers accounted for the following percentages of the Company’s accounts
receivable, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 16 | % | |
| 12 | % |
E | |
| 12 | % | |
| - | |
Total | |
| 28 | % | |
| 12 | % |
|
Accounts Receivable |
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 doubtful accounts 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 credit losses was approximately $11,000 as of each of the
periods ended June 30, 2024, and December 31, 2023.
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v3.24.2.u1
Basis of Presentation and Liquidity (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Revenues and Accounts Receivable Percentage of Major Customers |
For
the three months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Schedule of Revenues and Accounts Receivable Percentage of Major Customers
Customer | |
2024 | | |
2023 | |
A | |
| 22 | % | |
| 18 | % |
B | |
| 8 | % | |
| 11 | % |
D | |
| 3 | % | |
| 11 | % |
Total | |
| 33 | % | |
| 40 | % |
For
the six months ended June 30, 2024, and 2023, the following customers accounted for the following percentages of the Company’s
revenues, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 27 | % | |
| 19 | % |
B | |
| 7 | % | |
| 10 | % |
C | |
| 2 | % | |
| 13 | % |
Total | |
| 36 | % | |
| 42 | % |
As
of June 30, 2024, and December 31, 2023, the following customers accounted for the following percentages of the Company’s accounts
receivable, respectively:
Customer | |
2024 | | |
2023 | |
A | |
| 16 | % | |
| 12 | % |
E | |
| 12 | % | |
| - | |
Total | |
| 28 | % | |
| 12 | % |
|
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v3.24.2.u1
Fair Value Measurements (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis |
At
June 30, 2024 and December 31, 2023, the fair value measurements of the Company’s assets and liabilities measured on a recurring
basis were as follows:
Schedule
of Assets and Liabilities Measured at Fair Value on Recurring Basis
(in thousands) | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | | |
Significant Other Observable Inputs (Level 2) | | |
Significant Unobservable Inputs (Level 3) | |
| |
| |
June 30, 2024 | |
| | | |
| | | |
| | |
Cash | |
$ | 1,403 | | |
$ | - | | |
$ | - | |
Money market funds | |
| 1,677 | | |
| - | | |
| - | |
| |
| - | | |
| | | |
| | |
Cash and cash equivalents | |
$ | 3,080 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Cash | |
$ | 274 | | |
$ | - | | |
$ | - | |
Money market funds | |
| 2,515 | | |
| - | | |
| - | |
Certificate of deposit | |
| 1,518 | | |
| - | | |
| - | |
Cash and cash equivalents | |
$ | 4,307 | | |
$ | - | | |
$ | - | |
|
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- DefinitionTabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process.
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v3.24.2.u1
Intangible Assets and Goodwill (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Assets |
Intangible
assets as of June 30, 2024 and December 31, 2023 are set forth in the table below. Gross carrying values and accumulated amortization
of the Company’s intangible assets by type are as follows:
Schedule
of Intangible Assets
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Cost | | |
Accumulated Amortization | | |
Net | | |
Cost | | |
Accumulated Amortization | | |
Net | |
| |
(in thousands) | |
Customer relationships | |
$ | 540 | | |
| (175 | ) | |
$ | 365 | | |
$ | 540 | | |
| (159 | ) | |
| 381 | |
Total intangible assets | |
$ | 540 | | |
$ | (175 | ) | |
$ | 365 | | |
$ | 540 | | |
$ | (159 | ) | |
$ | 381 | |
|
Schedule of Future Amortization Expense |
As
of June 30, 2024, future amortization expense for each of the next five years is (in thousands):
Schedule
of Future Amortization Expense
Fiscal Years | |
| |
2024 (excluding the six months ended June 30, 2024) | |
$ | 16 | |
2025 | |
| 32 | |
2026 | |
| 32 | |
2027 | |
| 32 | |
2028 | |
| 32 | |
2029 | |
| 32 | |
|
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v3.24.2.u1
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
Schedule of Components of Lease Cost |
The
components of total lease costs were as follows:
Schedule of Components of Lease Cost
| |
Three
months ended June 30, 2024 | | |
Three
months ended June 30, 2023 | |
| |
(in thousands) | |
Operating lease cost | |
$ | 127 | | |
$ | 90 | |
Finance lease cost: | |
| | | |
| | |
Amortization of right-of-use assets | |
| 2 | | |
| 2 | |
Interest on lease liabilities | |
| 1 | | |
| 1 | |
Total finance lease cost | |
| 3 | | |
| 3 | |
Variable lease cost | |
| 14 | | |
| 3 | |
Total lease cost | |
$ | 144 | | |
$ | 96 | |
| |
Six months ended June 30, 2024 | | |
Six months ended June 30, 2023 | |
| |
(in thousands) | |
Operating lease cost | |
$ | 252 | | |
$ | 182 | |
Finance lease cost: | |
| | | |
| | |
Amortization of right-of-use assets | |
| 4 | | |
| 4 | |
Interest on lease liabilities | |
| 2 | | |
| 2 | |
Total finance lease cost | |
| 6 | | |
| 6 | |
Variable lease cost | |
| 25 | | |
| 7 | |
Total lease cost | |
$ | 283 | | |
$ | 195 | |
|
Schedule of Supplemental Cash Flow Information Related to Leases |
Supplemental
cash flow information related to leases was as follows:
Schedule of Supplemental Cash Flow Information Related to Leases
| |
Six months ended June 30, 2024 | | |
Six months ended June 30, 2023 | |
| |
(in thousands) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 316 | | |
$ | 160 | |
Financing cash flows from finance leases | |
$ | 4 | | |
$ | 4 | |
|
Schedule of Supplemental Balance Sheet Information Related to Leases |
Supplemental
balance sheet information related to leases was as follows:
Schedule of Supplemental Balance Sheet Information Related to Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(in thousands) | |
Operating lease right-of-use assets | |
$ | 1,550 | | |
$ | 1,803 | |
Finance lease right-of-use assets | |
$ | 1 | | |
$ | 4 | |
| |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 357 | | |
$ | 442 | |
Operating lease liabilities, net of current portion | |
| 1,222 | | |
| 1,390 | |
Total operating lease liabilities | |
$ | 1,579 | | |
$ | 1,832 | |
| |
| | | |
| | |
Current portion of finance lease liabilities | |
$ | 1 | | |
$ | 4 | |
Finance lease liabilities, net of current portion | |
| - | | |
| - | |
Total finance lease liabilities | |
$ | 1 | | |
$ | 4 | |
| |
| | | |
| | |
Weighted average remaining lease term | |
| | | |
| | |
Operating leases | |
| 4.0 years | | |
| 4.3 years | |
Finance leases | |
| 0.1 years | | |
| 0.6 years | |
| |
| | | |
| | |
Weighted average discount rate | |
| | | |
| | |
Operating leases | |
| 8.0 | % | |
| 8.0 | % |
Finance leases | |
| 8.0 | % | |
| 8.0 | % |
|
Schedule of Maturities of Lease Liabilities |
As
of June 30, 2024, maturities of lease liabilities were as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | | |
Finance Leases | |
| |
(in thousands) | |
2024 (excluding the six months ended June 30, 2024) | |
$ | 246 | | |
$ | 1 | |
2025 | |
| 435 | | |
| - | |
2026 | |
| 450 | | |
| - | |
2027 | |
| 450 | | |
| - | |
2028 | |
| 251 | | |
| - | |
Total future minimum lease payments | |
| 1,832 | | |
| 1 | |
Less imputed interest | |
| (253 | ) | |
| - | |
Total | |
$ | 1,579 | | |
$ | 1 | |
|
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Stock Plans and Share-Based Payments (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Fair Value Assumptions |
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 six months ended June 30, 2024.
Schedule of Fair Value Assumptions
Assumptions for Option Grants | |
| |
Stock Price Volatility | |
| 70.34 | % |
Risk-Free Interest Rate | |
| 4.45 | % |
Expected Life (in years) | |
| 6.08 | |
Expected Dividend Yield | |
| - | % |
|
X |
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v3.24.2.u1
Basis of Presentation and Liquidity (Details Narrative) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
Accumulated deficit |
$ 144,864,000
|
|
$ 144,406,000
|
Net cash (used in) provided by operating activities |
(1,173,000)
|
$ 502,000
|
800,000
|
Allowance for doubtful accounts receivable |
$ 11,000
|
|
$ 11,000
|
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v3.24.2.u1
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash |
$ 1,403
|
$ 274
|
Money market funds |
1,677
|
2,515
|
Certificate of deposit |
|
1,518
|
Cash and cash equivalents |
3,080
|
4,307
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash and cash equivalents |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash and cash equivalents |
|
|
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License and Supply Agreement, net (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
|
Dec. 11, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Capitalized intangible assets, gross |
|
$ 2,300,000
|
|
$ 2,300,000
|
|
|
Capitalized intangible assets, net |
|
243,000
|
|
243,000
|
|
$ 271,000
|
Accumulated amortization |
|
(175,000)
|
|
(175,000)
|
|
(159,000)
|
Amortization expense |
|
8,000
|
$ 11,000
|
|
|
|
Interest rate, description |
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
|
|
|
|
|
|
Accounts Payable and Accrued Liabilities [Member] |
|
|
|
|
|
|
Royalty expense |
|
|
|
|
$ 95,000
|
|
Cost of Sales [Member] |
|
|
|
|
|
|
Royalty expense |
|
|
95,000
|
|
$ 191,000
|
|
License and Supply Agreement [Member] |
|
|
|
|
|
|
Capitalized intangible assets, net |
|
200,000
|
|
200,000
|
|
300,000
|
Accumulated amortization |
|
2,000,000.0
|
|
$ 2,000,000.0
|
|
$ 1,900,000
|
Amortization expense |
|
$ 14,000
|
$ 33,000
|
|
|
|
License and Supply Agreement [Member] | April 23, 2014 through December 31, 2023 [Member] | Medica [Member] |
|
|
|
|
|
|
Royalty rate |
|
|
|
3.00%
|
|
|
X |
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Secured Note Payable (Details Narrative) - USD ($)
|
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 27, 2018 |
Secured Note [Member] |
|
|
|
Short-Term Debt [Line Items] |
|
|
|
Repayments of notes payable |
|
$ 71,000
|
|
Interest expense |
|
$ 1,000
|
|
Secured Promissory Note Agreement [Member] | Tech Capital, LLC [Member] |
|
|
|
Short-Term Debt [Line Items] |
|
|
|
Principal amount of secured note payable |
|
|
$ 1,200,000
|
Debt maturity date |
Apr. 01, 2023
|
|
|
Debt interest rate |
8.00%
|
|
|
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Principal
and interest payments were due on the first day of each month commencing on May 1, 2018
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|
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Schedule of Supplemental Balance Sheet Information Related to Leases (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases |
|
|
Operating lease right-of-use assets |
$ 1,550
|
$ 1,803
|
Finance lease right-of-use assets |
1
|
4
|
Current portion of operating lease liabilities |
357
|
442
|
Operating lease liabilities, net of current portion |
1,222
|
1,390
|
Total operating lease liabilities |
1,579
|
1,832
|
Current portion of finance lease liabilities |
1
|
4
|
Finance lease liabilities, net of current portion |
|
|
Total finance lease liabilities |
$ 1
|
$ 4
|
Weighted average remaining lease term, Operating leases |
4 years
|
4 years 3 months 18 days
|
Weighted average remaining lease term, Finance leases |
1 month 6 days
|
7 months 6 days
|
Operating leases |
8.00%
|
8.00%
|
Finance leases |
8.00%
|
8.00%
|
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v3.24.2.u1
Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
|
Operating Leases, 2024 |
$ 246
|
|
Operating Leases, 2025 |
435
|
|
Operating Leases, 2026 |
450
|
|
Operating Leases, 2027 |
450
|
|
Operating Leases, 2028 |
251
|
|
Operating Leases, Total future minimum lease payments |
1,832
|
|
Operating Leases, Less imputed interest |
(253)
|
|
Operating Leases, Total |
1,579
|
$ 1,832
|
Finance Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
|
Finance Leases, 2024 |
1
|
|
Finance Leases, 2025 |
|
|
Finance Leases, 2026 |
|
|
Finance Leases, 2027 |
|
|
Finance Leases, 2028 |
|
|
Finance Leases, Total future minimum lease payments |
1
|
|
Finance Leases, Less imputed interest |
|
|
Finance Leases, Total |
$ 1
|
$ 4
|
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v3.24.2.u1
Stock Plans and Share-Based Payments (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
May 07, 2019 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Share based compensation expense |
|
|
$ 26,000
|
$ 513,000
|
|
Income tax benefit |
$ 0
|
$ 0
|
0
|
0
|
|
Unrecognized compensation expense |
625,000
|
|
$ 625,000
|
|
|
Unrecognized compensation expense, period for recognition |
|
|
2 years 8 months 12 days
|
|
|
SRP Equity Incentive Plan [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Allocated share based compensation expense |
|
|
|
27,000
|
|
Number of shares reserved and authorized for awards |
|
|
|
|
150,000
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Allocated share based compensation expense |
28,000
|
169,000
|
$ 11,000
|
349,000
|
|
Share based compensation expense |
62,000
|
|
120,000
|
|
|
Unvested stock options employee termination expense |
33,000
|
|
109,000
|
|
|
Share-Based Payment Arrangement, Option [Member] | Selling, General and Administrative Expenses [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Allocated share based compensation expense |
27,000
|
156,000
|
8,000
|
315,000
|
|
Share-Based Payment Arrangement, Option [Member] | Research and Development Expense [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Allocated share based compensation expense |
2,000
|
13,000
|
3,000
|
34,000
|
|
Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Allocated share based compensation expense |
7,000
|
$ 25,000
|
15,000
|
$ 38,000
|
|
Unvested Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Unrecognized compensation expense |
$ 0
|
|
$ 0
|
|
|
Employees [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Stock options, granted |
85,198
|
|
85,198
|
|
|
Fair value of stock options, granted |
$ 100,000
|
|
$ 100,000
|
|
|
Employees [Member] | Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Number of shares issued |
|
|
|
23,781
|
|
Board [Member] | Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Number of shares issued |
|
|
|
133,722
|
|
Contractors [Member] | Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Number of shares issued |
|
|
|
30,000
|
|
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Mar. 31, 2023 |
Feb. 28, 2022 |
Sep. 30, 2018 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2020 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
Inventory write down |
|
|
|
|
$ 180,000
|
$ 106,000
|
|
Specialty Renal Products, Inc. [Member] |
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
Outstanding indebtness |
$ 1,500,000
|
|
|
|
|
|
|
Inventory write down |
|
|
|
$ 24,000,000
|
|
|
|
SRP Purchase Agreement Closing [Member] |
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
Sale of stock |
|
$ 188,000
|
|
|
|
|
|
Loan Agreement [Member] | Specialty Renal Products, Inc. [Member] |
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
$ 1,300,000
|
Proceeds from Loans |
|
|
|
|
|
|
$ 1,000,000.0
|
Specialty Renal Products, Inc. [Member] |
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
Number of shares purchase |
|
62,500
|
|
|
|
|
|
Ownership percentage |
|
62.50%
|
|
|
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
Issuance of shares |
|
700,003
|
700,003
|
|
|
|
|
Proceeds from sale of preferred stock |
|
$ 3,500,000
|
$ 3,500,000
|
|
|
|
|
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