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Item 7. Management’s Discussion and Analysis

2025-03-20 compared with 2024-03-21 · 104 added, 164 removed, 75 unchanged (78% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations provides information management believes to be relevant to understanding the financial condition and results of

operations of the Company.

The discussion focuses on our financial results of operations for the years ended December 31, 2024 and 2023 .

You should read this discussion and analysis in conjunction with our consolidated financial statements and

related notes thereto on December 31, 2023, and 2022, and for years 2023, and 2022, which are presented within Part II Item 8.

You should read this discussion and analysis in conjunction with our consolidated financial statements and related notes thereto for the years ended December 31, 2024 , and 2023 , which are presented within Part II, Item 8.

"Financial Statements and Supplementary Data" in this Annual Report on Form 10-K.

Amounts reported in thousands within this

annual report are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in thousands due to rounding.

Amounts reported in thousands within this annual report

are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in thousands due to rounding.

Executive Summary

We realized significant revenue growth during the year ended December 31, 2024 , with a 60% growth in revenue to $32.6 million for the year ended December 31, 2024 , as compared to $20.4 million in 2023 .

Gross margins

also decreased to 70% from 74% in 2022.

As the Company continues to focus on profitable growth, we have also reduced our operating loss by 94% to $0.5 million for the year ended December 31, 2023.

Net loss for the year ended December 31, 2023, was $25.8 million, or ($0.03) per basic and diluted share, compared to a net loss of $10.3 million, or ($0.02) per basic and diluted share, for the year ended December 31,

2022, a variance of $15.5 million, which was largely driven by a non-cash change in the fair value of derivatives.

Operating loss for the year ended December 31, 2023, was $540 thousand, compared to $9.0 million for the year ended December 31, 2022.

We continue to focus on profitable growth and reduction in operating expenses.

We believe these improvements sets the stage for additional growth as we head into 2024.

Merger Agreement with SEPA

On August 23, 2023, we entered into an Agreement and Plan of Merger (the “ Merger Agreement ”) by and among SEP Acquisition Corp., a Delaware corporation (“ SEPA ”), SEP Acquisition Holdings

Inc., a Nevada corporation, and a wholly owned subsidiary of SEPA (“ Merger Sub ”).

Pursuant to the terms of the Merger Agreement, a business combination between the Company and SEPA (the “ Merger ”) will be affected.

More specifically, and

as described in greater detail below, at the effective time of the Merger (the “ Effective Time ”):

Merger Sub will merge with and into the Company, with the Company being the surviving company following the merger.

Each issued and outstanding share of the Company common stock will automatically be converted into Class A common stock of SEPA, par value $0.0001 per share, at the Conversion Ratio (as defined in the Merger

Outstanding Company convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.

Pursuant to the terms of the Merger Agreement, the holders of (i) Company common stock, (ii) in the money options to purchase Company common stock, (iii) in the money warrants to purchase Company common

stock, and (iv) convertible promissory notes, collectively will be entitled to receive 7,793,000 shares of Class A Common Stock of SEPA.

Out-of-the-money options and out-of-the-money warrants will be assumed by SEPA and converted into options or

warrants, respectively, exercisable for shares of Class A Common Stock based on the Conversion Ratio;

however, such out-of-the-money options and out-of-the-money warrants shall not be reserved for issuance from the Merger Consideration.

Gross margins also increased to 75% from 70% in 2023 .

As the Company continues to focus on profitable growth, we have also increased our operating income by 1103% to $5.4 million for the year ended December 31, 2024, compared to an operating loss of $0.5 million for the year ended December 31, 2023.

Net loss for the year ended December 31, 2024 , was $31.4 million , or $7.03 per basic and diluted share, compared to a net loss of $25.8 million , or $12.19 per basic and diluted share, for the year ended December 31, 2023 , an increase of $5.6 million , which was largely driven by a non-cash change in the fair value of derivatives.

We believe these improvements set the stage for additional growth as we head into 2025.

Recent Developments

On March 7, 2025, our common stock began trading on The Nasdaq Global Market under the ticker symbol “SNWV.”

Non-GAAP Financial Measures

Throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations, we present certain financial measures that facilitate management’s review of the operational

performance of the Company and as a basis for strategic planning;

Throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations, we present certain financial measures that facilitate management’s review of the operational performance of the Company and as a basis for strategic planning;

however, such financial measures are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S.”) (“U.S.

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The Company uses Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) and Adjusted EBITDA to assess its operating performance.

Adjusted EBITDA is Earnings before Interest, Taxes,

Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or non-recurring one-time charges.

EBITDA and Adjusted EBITDA should not be considered as alternatives to net loss as a measure of

financial performance or any other performance measure derived in accordance with GAAP, and they should not be construed as an inference that our future results will be unaffected by unusual or non-recurring items.

These non-GAAP financial measures

are presented in a consistent manner for each period, unless otherwise disclosed.

Adjusted EBITDA is Earnings before Interest, Taxes, Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or non-recurring infrequent charges.

EBITDA and Adjusted EBITDA should not be considered as alternatives to net loss as a measure of financial performance or any other performance measure derived in accordance with U.S.

GAAP, and they should not be construed as an inference that our future results will be unaffected by unusual or infrequent items.

These non-GAAP financial measures are presented in a consistent manner for each period, unless otherwise disclosed.

The Company uses these measures for the purpose of evaluating its historical and prospective financial performance, as well as its performance relative to competitors.

These measures also help the Company to make operational and strategic decisions.

The Company believes that providing this information to investors, in addition to GAAP measures, allows them to see the Company’s results through the eyes of

Management, and to better understand its historical and future financial performance.

These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when

considered alongside other GAAP measures.

EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of our results as reported under GAAP.

Some of these

limitations are that EBITDA and Adjusted EBITDA:

The Company believes that providing this information to investors, in addition to U.S.

GAAP measures, allows them to see the Company’s results through the eyes of management, and to better understand its historical and future financial performance.

These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when considered alongside other U.S.

GAAP measures.

EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of our results as reported under U.S.

Some of these limitations are that EBITDA and Adjusted EBITDA:

• Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments.

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• Do not reflect interest expense, or the amount necessary to service our outstanding debt.

As presented in the GAAP to Non-GAAP Reconciliations section below, our non-GAAP financial measure excludes the impact of certain charges that contribute to our net loss (Non-GAAP Adjustments).

(in thousands)

As presented in the GAAP to Non-GAAP Reconciliations section below, our non-GAAP financial measures exclude the impact of certain charges that contribute to our net loss.

For the year ended

(in thousands) 2024 2023

Net (Loss) Income $ (31,372) $ (25,807)

Non-GAAP Adjustments:

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Depreciation and amortization 1,145 1,028

EBITDA $ (16,590) $ (9,156)

Non-GAAP Adjustments for Adjusted EBITDA:

Change in fair value of derivative liabilities 31,413 9,621

Other non-cash or non-recurring charges:

Other non-cash or infrequent charges:

Gain on extinguishment of debt (6,326) -

Severance agreement and legal settlement 741 -

Release of historical accrued expenses (1,547) (1,866)

Stock-based compensation 1,514 -

Shares issued for services - 224

Loss on issuance of debt

Loss on extinguishment of debt

License and option agreement (2,500) -

Prepaid legal fees expensed from termination of Merger Agreement 457 -

Adjusted EBITDA $ 7,162 $ (1,177)

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The following table sets forth our consolidated statement of operations:

For the Years Ended December 31,

For the Years Ended December 31, Change

(in thousands) 2024 2023 $ %

Revenue $ 32,634 $ 20,398 $ 12,236 60 %

Cost of revenue 8,084 6,035 2,049 34 %

Gross margin 24,550 14,363 10,187 71 %

Gross margin % 75 % 70 %

Operating expenses:

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Depreciation and amortization 789 752 37 5 %

Operating loss

Operating income (loss) 5,417 (540) 5,957 1103 %

Other expense, net (36,762) (25,263) (11,499) 46%

Income tax expense 27 4 23 575 %

Revenues for the year ended December 31, 2023, were $20.4 million, compared to $16.7 million for the same period in 2022, an increase of $3.7 million or 22%.

The increase in net sales was primarily driven by the growth

in quantity of disposables sold, which increased by 9% in 2023 as compared to 2022.

Pricing of the UltraMIST ® system and disposables also showed growth in 2023 as

compared to 2022, disposables average selling price increased over 10% in 2023, and system revenue increased 28% in 2023.

Revenue from UltraMIST totaled 90% of total revenue in 2023 and 2022.

Net loss $ (31,372) $ (25,807) $ (5,565) 22 %

Revenues for the year ended December 31, 2024 were $32.6 million , compared to $20.4 million for 2023 , an increase of $12.2 million or 60% .

The increase in net sales was primarily driven by the growth in quantity of UltraMIST ® disposables

and systems sold.

The quantity of UltraMIST ® disposables sold increased by 37% in 2024 as compared to 2023 .

The quantity of UltraMIST ® systems sold increased by 77% in 2024 as compared to 2023.

Pricing of the UltraMIST ® system and disposables also showed growth in 2024 as compared to 2023;

disposables average selling price increased 21% in 2024 , and systems average selling price increased 10% in 2024 .

Revenue from UltraMIST ® totaled over 98% of total revenue in 2024 and 90% in 2023 .

Cost of Revenue

Cost of revenues for the year ended December 31, 2023, was $6.0 million, compared to $4.3 million for the same period in 2022.

Gross profit as a percentage of revenues was 70% for the year ended December 31, 2023,

compared to 74% for the same period in 2022.

This decrease in gross margin was largely driven by increased one time inventory write offs and costs to support our growth and alleviate our inventory constraint in 2023.

Cost of revenues for the year ended December 31, 2024 was $8.1 million , compared to $6.0 million for 2023 .

Gross profit as a percentage of revenues was 75% for the year ended December 31, 2024 , compared to 70% for the same period in 2023 .

This increase in gross margin was largely driven by increased pricing on our UltraMIST systems and applicators.

General and Administrative

General and administrative expenses for the year ended December 31, 2023, were $8.7 million as compared to $12.6 million for the same period in 2022, a decrease of $3.9 million, or 31%.

The decrease in 2023 as compared

to 2022 was primarily due to the higher legal costs related to patent work and securities work incurred in 2022.

General and administrative expenses for the year ended December 31, 2024 were $11.3 million as compared to $8.7 million for 2023 , an increase of $2.7 million , or 31% .

The increase in 2024 as compared to 2023 was primarily due to increased headcount, severance and legal settlement expenses, and non-cash charges for stock-based compensation expense.

Selling and Marketing

Selling and marketing expenses for the year ended December 31, 2023, were $4.9 million as compared to $7.4 million for the same period in 2022, a decrease of $2.6 million, or 34%.

The year-over-year decrease in sales

and marketing expenses in 2023 was a result of cost saving initiatives taken by management.

Selling and marketing expenses for the year ended December 31, 2024 were $6.3 million as compared to $4.9 million for 2023 , an increase of $1.4 million , or 29% .

The year-over-year increase in sales and marketing expenses in 2024 was largely driven by increased commission expenses due to increased sales.

Research and Development

Research and development expenses for the year ended December 31, 2023, were $0.6 million, compared to $0.6 million for the same period in 2022.

The research and development costs in 2023 remained consistent with the

costs in 2022.

Research and development expenses for the year ended December 31, 2024 were $0.7 million , compared to $0.6 million for 2023 .

The research and development costs in 2024 remained approximately consistent with the costs in 2023 .

Other Income (Expense), net

Other expense, net consists of the following:

For the years ended December 31,

For the years ended December 31, Change

2024 2023 $ %

Interest expense $ (13,637) $ (15,623) $ 1,986 (13 %)

Change in fair value of derivatives

Loss on issuance of debt

Gain/(loss) on extinguishment of debt

Other expense

Other expense, net

Change in fair value of derivatives (31,413) (9,621) (21,792) nm

Gain on extinguishment of debt 6,326 - 6,326 nm

Other expense (893) (19) (874) nm

Other income 2,855 - 2,855 nm

Other expense, net $ (36,762) $ (25,263) $ (11,499) nm

nm - not meaningful

Other expenses totaled $25.2 million for the year ended December 31, 2023, as compared $1.3 million for the same period in 2022, an increase of $23.9 million.

The increase was primarily driven by an increased loss from

the change in the fair value of derivative liability of $26.3 million, offset by a decrease in loss on issuance of debt along with the loss on extinguishment of debt.

The increased interest expense of $1.5 million was the result of higher levels of

debt outstanding during 2023, due to new issuances of convertible debt, compared with 2022.

The change in fair value of the derivative liability relates to warrants issued during 2023 and 2022 with the convertible debt.

Other expenses totaled $36.8 million for the year ended December 31, 2024 , as compared $25.3 million for 2023 , an increase of $11.5 million .

The increase was primarily driven by an increased loss from the change in the fair value of derivative liability of $21.8 million , partially offset by a gain on the extinguishment of debt of $6.3 million and other income of $2.5 million from a license and option agreement.

The change in fair value of the derivative liability mainly relates to warrants issued during 2024, 2023, and 2022 with the convertible debt.

That convertible debt and associated warrants were converted to common stock in October 2024, as further discussed in Note 16 to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data”.

The gain on extinguishment of debt was mainly due to the settlement of outstanding notes to Celularity and HealthTronics, as further discussed in Note 10 to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data”.

Liquidity and Capital Resources

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As of December 31, 2024, we had an accumulated deficit of $251 million .

Historically, our operations have

primarily been funded from the sale of capital stock, notes payable, and convertible debt securities.

In August 2022,November 2022, May 2023 and December 2023, we entered into a Securities Purchase Agreements (the “Purchase Agreements”), for the sale in a private placement of (i) Future Advance

Convertible Promissory Notes (the “Notes”) in an aggregate principal amount of $16.2 million in August 2022,$4.0 million in November 2022, $1.2 million in May 2023, and $1.9 million in December 2023 (ii) Common Stock Purchase Warrants to purchase

an additional 581.6 million shares of common stock with an exercise price of $0.067 per share and (iii) Common Stock Purchase Warrants to purchase an additional 581.6million shares of common stock with an exercise price of $0.04 per share.

Pursuant to the Notes, the Company promised to pay in cash and/or in shares of common stock, at a conversion price of $0.04 (the “Conversion Price”), the principal amount and interest at a rate of 15%

per annum on any outstanding principal.

The Conversion Price of the Notes is subject to adjustment, including if the Company issues or sells shares of common stock for a price per share less than the Conversion Price of the Notes or if the Company

lists its shares of common stock on The Nasdaq Capital Market and the average volume weighted average price of such common stock for the five trading days preceding such listing is less than $0.04 per share;

provided, however, that the Conversion

Price shall never by less than $0.01.

The Notes contain customary events of default and covenants, including limitations on incurrences of indebtedness and liens.

In August 2023 and November 2023, the Company utilized its election to convert the August and November issued 2022 Convertible Notes Payable into shares of common stock upon the Notes’ maturity.

August notes totaling $16.2 million in principal and $2.4 million in interest were converted to 464,440,813 shares of common stock.

The November notes totaling $4.0 million in principal and $0.6 million in interest were converted to 114,481,063

shares of common stock.

In July 2023, we issued Asset-Backed Secured Promissory Notes in an aggregate principal amount of $4.6 million to certain accredited investors at an original issue discount of 33.33%.

bear an interest rate of 0% per annum and matured on January 21, 2024.

We received total proceeds of approximately $3.0 million.

We also entered into a side letter, pursuant to which, we issued Future Advance Convertible Promissory Notes, on

January 21, 2024, with the same principal amount as the principal amount of such Notes, plus any accrued and unpaid interest and two Common Stock Purchase Warrants, substantially in the forms of the Notes and Common Stock Purchase Warrants

disclosed in the previous paragraphs.

In August 2020, the Company issued a Senior Secured Promissory Note Payable (the “Senior Secured Note”) to NH Expansion Credit Fund Holdings L.P.

pursuant to which the Company had outstanding debt of

$21.5 million as of December 31, 2023.

Interest is charged at the greater of the prime rate or 3% plus 9%, paid quarterly.

As of December 31, 2023, the Company is in default of the minimum liquidity provisions on the Senior Secured Note and, as a

result, is accruing interest at the default interest rate of an incremental 5%.

Interest expense on the Senior Secured Note totaled $6.9 million and $5.9 million for the years ended December 31, 2023, and 2022, respectively.

Historically, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities.

See Notes 1, 10, 11, 15, and 16, to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information regarding additional

debt commitments, the convertible notes and accompanying warrants issued in May and December 2023, $4.5 million in asset-backed secured promissory notes, and the Senior Secured Note.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information regarding the Convertible Promissory Notes, Senior Secured Note, Reverse Stock Split, and the October 2024 transaction.

The following table presents summarized cash flow information:

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(in thousands) 2024 2023

Cash flows used by operating activities

Cash flows provided by investing activities

Cash flows provided by (used in) operating activities $ 2,455 $ (4,538)

Cash flows (used in) provided by investing activities $ (490) $ 21

Cash flows provided by financing activities $ 6,354 $ 5,211

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We have improved our cash flow from operations in 2024 as compared to 2023, which was driven by increased emphasis on improved cash management and operating expense management.

We also invested in

our inventory in 2023, increasing our inventory levels by $2 million for the year ended December 31, 2023.

Additional volatility in adjustments of cash flows from operations is the change in fair value of derivative liabilities connected to our

convertible debt and warrants issued with the August and November 2022, and May and December 2023 financings.

The Company recognized a loss on these liabilities of $9.6 million for the year ended December 31, 2023, as compared to a gain of $16.7

million for the year ended December 31, 2022.

Additional volatility in adjustments of cash flows from operations is the change in fair value of derivative liabilities connected to our convertible debt and warrants issued.

The Company recognized a loss on these liabilities of $31.4 million for the year ended December 31, 2024, as compared to a loss of $9.6 million for the year ended December 31, 2023.

Cash Flows Provided by Financing Activities

Cash flows provided by financing activities decreased primarily due to the improvement of operating cash flows which reduced our required cash to fund our growth and operations.

For the year ended

December 31, 2023, we received proceeds of $6.0 million from the issuance of the convertible promissory notes and asset backed secured promissory notes discussed above in this section, Liquidity and Capital Resources, as compared to $16.2 million

for the year ended December 31, 2022.

Cash flows provided by financing activities increased while also paying off outstanding debt.

For the year ended December 31, 2024, we received proceeds of $12.1 million from the issuance of the convertible promissory notes, sales of common stock, and proceeds from promissory note payable as compared to $6.0 million for the year ended December 31, 2023.

In 2024, we paid off outstanding debt owed to Celularity, HealthTronics, and our factoring line of credit for a total of $5.0 million.

Going Concern

The continuation of our business is dependent upon raising additional capital to fund operations.

This, as well as the events of default on various notes payable, raise substantial doubt

about our ability to continue as a going concern for a period of at least twelve months.

Management plans to obtain additional capital in 2024 through the completion of the Merger Agreement.

We could also obtain additional capital through the

conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt.

These possibilities, to the extent available, may be on terms that result in significant dilution

to our existing stockholders.

Although no assurances can be given that our plans to obtain additional capital will be successful or on the terms or timeline we expect, or at all, management believes that potential additional issuances of

equity or other potential financing transactions, as discussed above, should provide the necessary funding for us over the next 12 months.

If these efforts are unsuccessful, we may be required to significantly

curtail or discontinue operations or obtain funds through financing transactions with unfavorable terms.

The Company has incurred recurring operating losses in prior years, has negative working capital, and the Senior Secured Note becomes due in September 2025, which raises substantial doubt about our ability to continue as a going concern for a period of 12 months from the filing of the Form 10-K.

During the current fiscal year, the Company has achieved operating income, reflecting a significant improvement in its financial performance.

The Company is addressing its financial obligations, including the significant portion of debt that is coming due in September 2025.

Management is actively engaged in discussions with lenders and financial institutions to refinance this debt, which will extend the maturity of the debt and provide additional liquidity to support ongoing operations and strategic initiatives.

Although no assurances can be given that our plans to obtain refinancing will be successful or on the terms or timeline we expect, or at all, management believes that the actions taken to date, along with the planned initiatives, will enable the Company to meet its obligations as they become due and to continue as a going concern..

If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or obtain funds through financing transactions with unfavorable terms.

See Note 2 to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information on our ability to continue as a going

Critical Accounting Policies and Estimates

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information on our ability to continue as a going concern.

Critical Accounting Estimates

We consider an accounting estimate to be critical if:

(1) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (2) changes in the estimate are reasonably likely to occur from period to period, or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations.

Management has discussed the development and selection of these critical accounting estimates with the Audit Committee of our Board of Directors.

In addition, there are other items within our consolidated financial statements that require estimation, but are not deemed critical as defined above.

Changes in estimates used in these and other items could have a material impact on our consolidated financial statements.

We have used various accounting policies to prepare the consolidated financial statements in accordance with U.S.

Our significant accounting policies are disclosed in Note 3 to the consolidated financial

statements in Part II Item 8.

Our significant accounting policies are disclosed in Note 3 to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

The preparation of the consolidated financial statements, in conformity with U.S.

GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues,

and expenses.

GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses.

These estimates reflect our best judgment about economic and market conditions and the potential effects on the valuation and/or carrying value of assets and liabilities based upon relevant information available.

We base our estimates

on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent

from other sources.

We base our estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

The following accounting estimates are deemed critical:

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We may be involved in legal actions involving product liability, intellectual property and commercial disputes, tax disputes, and governmental proceedings and investigations.

The outcomes of these legal actions are not

completely within our control and may not be known for prolonged periods of time.

In some actions, the enforcement agencies or private claimants seek damages that could require significant expenditures or result in lost revenues or limit our ability

to conduct business in the applicable jurisdictions.

Estimating probable losses from our litigation and governmental proceedings is inherently difficult, particularly when the matters are in early procedural stages, with incomplete scientific facts

or legal discovery;

The outcomes of these legal actions are not completely within our control and may not be known for prolonged periods of time.

In some actions, the enforcement agencies or private claimants seek damages that could require significant expenditures or result in lost revenues or limit our ability to conduct business in the applicable jurisdictions.

Estimating probable losses from our litigation and governmental proceedings is inherently difficult, particularly when the matters are in early procedural stages, with incomplete scientific facts or legal discovery;

involve unsubstantiated or indeterminate claims for damages;

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or could result in a change in business practice.

The Company records a liability in the consolidated

financial statements for loss contingencies when a loss is known or considered probable, and the amount may be reasonably estimated.

If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better

estimate than any other, the minimum amount of the range is accrued.

The Company records a liability in the consolidated financial statements for loss contingencies when a loss is known or considered probable, and the amount may be reasonably estimated.

If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued.

If a loss is reasonably possible but not known or probable, and may be reasonably estimated, the estimated loss or range of loss is disclosed.

Our significant legal proceedings are

discussed in Note 21 to the consolidated financial statements in Part II Item 8.

The Company has reserved approximately $150 thousand for unasserted claims.

Our significant legal proceedings are discussed in Note 21 to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

Derivative Liabilities from Embedded Conversion Options and Warrants

The Company classified certain convertible instruments as having embedded conversion options which qualified as derivative financial instruments to be separately accounted for.

also determined that certain warrants also qualified as derivative financial instruments.

Various valuation models were used to estimate the fair value of these derivative financial instruments that are classified as derivative liabilities on the

consolidated balance sheets.

Derivative Liabilities from Warrants

The Company determined that certain warrants qualified as derivative financial instruments.

Various valuation models were used to estimate the fair value of these derivative financial instruments that are classified as derivative liabilities on the consolidated balance sheets.

The models include subjective input assumptions that can materially affect the fair value estimates and as such are subject to uncertainty.

Our significant input assumptions are discussed in Note 13 to the

consolidated financial statements in Part II Item 8.

The Company's volatility is the most significant assumption and changes over time with the market.

Our significant input assumptions are discussed in Note 13 to the consolidated financial statements in Part II, Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis