EKSO BIONICS HOLDINGS INC
For the period ended Dec 31, 2023. Filed Mar 4, 2024.
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FY2023 · Filed Mar 4, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
| Part I | ||
|---|---|---|
| Item 1 | Business | 4 |
| Item 1A | Risk Factors | 11 |
| Item 1B | Unresolved Staff Comments | 29 |
| Item 1C | Cybersecurity | 29 |
| Item 2 | Properties | 29 |
| Item 3 | Legal Proceedings | 29 |
| Item 4 | Mine Safety Disclosures | 29 |
| Part II | ||
| Item 5 | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 30 |
| Item 6 | Reserved | 30 |
| Item 7 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 31 |
| Item 7A | Quantitative and Qualitative Disclosures About Market Risk | 38 |
| Item 8 | Financial Statements and Supplementary Data | 39 |
| Item 9 | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 75 |
| Item 9A | Controls and Procedures | 75 |
| Item 9B | Other Information | 75 |
| Item 9C | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 75 |
| Part III | ||
| Item 10 | Directors, Executive Officers and Corporate Governance | 76 |
| Item 11 | Executive Compensation | 76 |
| Item 12 | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 76 |
| Item 13 | Certain Relationships and Related Transactions and Director Independence | 76 |
| Item 14 | Principal Accountant Fees and Services | 76 |
| Part IV | ||
| Item 15 | Exhibits, Financial Statements and Financial Statement Schedules | 77 |
| Item 16 | 10-K Summary | 81 |
| Signatures | 82 | |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, or this Annual Report, contains forward-looking statements, including, without limitation, in the sections captioned “Business,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere. Any and all statements contained in this Annual Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future,” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Annual Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of exoskeleton products for humans, (ii) the manufacturing of our products and strengthening our supply chain, and potential opportunities for strategic partnerships, (iii) beliefs regarding regulatory path for our products, including potential approvals required and timing of approvals, (iv) statements regarding the financial and operational impacts on our business following the completion of the integration of our acquisition from Parker Hannifin Corporation of certain assets related to Parker Hannifin Corporation's human motion control business, and software applications, support services and cloud environments related to such business in December 2022 (the "HMC Acquisition"), (v) our future financial performance, including any statement contained in a discussion and analysis of our financial condition by management or in the results of operations included pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"), (vi) our beliefs regarding the potential for commercial opportunities, including for exoskeleton technology and, our exoskeleton products, and for strategic partnerships, (vii) our beliefs regarding potential clinical and other health benefits of our medical devices, (viii) the actions we will take in seeking a reimbursement from Centers for Medicare and Medicaid Services ("CMS") and the success of such actions, the timing and amounts of potential CMS reimbursement, (ix) our ability to obtain CE certificates registered by Ekso Bionics, Inc. for our Ekso Indego Therapy and Ekso Indego Personal devices (x) the impact and effects of global health events and other risk factors on our business, results of operations or prospects, and (xi) the assumptions underlying or relating to any statement described in points (i) through (x) above.
The forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon our current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which we have no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's ability to obtain reimbursement from CMS at acceptable levels or at all and the effect and timing of CMS decisions with respect thereto, the highly competitive markets in which the Company’s products are sold, the Company's significant losses to date and anticipated future losses, the new and unproven nature of the market for the Company’s products, the long, cyclical and variable sales cycles for the Company’s products, the factors outside the Company’s control that affect the production and sales of its products, which include but are not limited to disruptions in the global supply chain, the costs related to and impacts of potential failure of the Company to obtain or maintain protection for the Company's intellectual property rights, the inability to successfully consummate and integrate acquisitions, including the HMC Acquisition, the failure of the Company to obtain or maintain regulatory approval to market the Company's medical devices, risks related to product liability, recall and warranty claims, the volatility of the market price of and limited trading in our common stock. A description of some of the risks and uncertainties that could cause our actual results to differ materially from those described by the forward-looking statements in this Annual Report appears in the section captioned “Risk Factors” and elsewhere in this Annual Report.
Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We disclaim any obligation to update the forward-looking statements contained in this Annual Report to reflect any new information or future events or circumstances or otherwise.
Readers should read this Annual Report in conjunction with the discussion under the caption “Risk Factors,” our financial statements and the related notes thereto in this Annual Report, and other documents which we may file from time to time with the SEC.
Notes regarding references to Ekso Bionics
In this Annual Report, the “Company”, “we”, “its” and “our” refers to Ekso Bionics Holdings, Inc. and its wholly owned subsidiaries, and “Ekso Bionics” refers to Ekso Bionics, Inc. as it existed prior to the January 15, 2014 merger of our wholly owned subsidiary, Ekso Acquisition Corp., with and into Ekso Bionics, Inc., or the Merger. Ekso Bionics was the surviving corporation in the Merger and became our wholly owned subsidiary, and all of the outstanding Ekso Bionics stock was converted into shares of our common stock. Ekso®, Ekso Bionics®, EksoWorks®, EksoZeroG®, EksoNR™, EksoZeroG™, EVO™, EksoPulse™, Indego®, and Nomad® are registered and unregistered trademarks of the Company. All other trademarks that may appear in this Annual Report are the property of their respective owners.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.