10-Q: Ekso Bionics Reports Steep Revenue Decline, Raises Going Concern Doubts Amid Liquidity Crunch

Ekso Bionics Holdings, Inc. reported a significant drop in second-quarter revenue and an increased operating loss, leading management to express substantial doubt about its ability to continue as a going concern without further financing.

Summary

• Revenue for the three months ended June 30, 2025, decreased by 58% to $2.057 million, down from $4.950 million in the same period of 2024, primarily due to short-term delays in closing two multiple-device sale contracts.
• For the six months ended June 30, 2025, revenue decreased by 38% to $5.432 million, compared to $8.706 million in the prior year period.
• Gross profit for the second quarter of 2025 fell by 69% to $0.819 million, with gross margin declining to 40% from 53% in Q2 2024.
• Operating loss for the three months ended June 30, 2025, increased by 70% to $(3.975) million, compared to $(2.335) million in Q2 2024.
• Net loss for the second quarter of 2025 was $(2.709) million, an increase from $(2.416) million in Q2 2024.
• As of June 30, 2025, cash and restricted cash stood at $5.242 million, down from $6.493 million at December 31, 2024.
• The company reported an accumulated deficit of $256.301 million as of June 30, 2025.
• Unrestricted cash of approximately $3.242 million as of June 30, 2025, is estimated to fund operations only into the fourth quarter of 2025.
• A 1-for-15 reverse stock split was effected on June 2, 2025, and the company regained Nasdaq compliance on June 13, 2025.
• CMS approved a payment level of approximately $91,000 for Medicare reimbursement of the Ekso Indego Personal device, effective April 1, 2024, with the first claim reimbursed in July 2024 and a second in April 2025 after an appeal.
• An impairment loss of $180,000 was recognized on an intangible asset due to the termination of a Knee License Agreement with Vanderbilt University on April 16, 2025.

Sentiment

Score: 3

Explanation: The company faces severe liquidity challenges, explicitly stating "substantial doubt" about its ability to continue as a going concern. Revenue has significantly declined, gross margins are compressed, and operating losses are increasing. While there are positive developments in CMS reimbursement for a key product, the overall financial health is precarious, heavily reliant on uncertain future capital raises, and subject to significant dilution risk. The current financial position indicates a high risk of capital impairment.

Positives

• Net cash used in operating activities decreased by $0.7 million for the six months ended June 30, 2025, compared to the same period of 2024, due to higher collections of accounts receivable, cost savings on supply chain, reduction in service costs, and other operating efficiencies.
• Net loss for the six months ended June 30, 2025, decreased by $0.2 million compared to the same period of 2024, primarily due to a significant unrealized gain on foreign exchange.
• Successfully regained compliance with Nasdaq's minimum bid price requirement on June 13, 2025, following a 1-for-15 reverse stock split.
• CMS approved a payment level of approximately $91,000 for Medicare reimbursement of the Ekso Indego Personal device, effective April 1, 2024, creating potential for increased demand.
• The first Ekso Indego Personal CMS reimbursement claim was received in July 2024, and a second in April 2025 after a favorable Administrative Law Judge response.
• Building a sales backlog for the Ekso Indego Personal device, with approximately 45 individuals believed to qualify for reimbursement in the coming months.
• Signed distribution agreements with National Seating & Mobility and Bionic Prosthetics & Orthotics Group to expand sales of Ekso Indego Personal.
• Research and development expenses decreased by 24% for the three months and 18% for the six months ended June 30, 2025, primarily due to lower headcount and reduced use of product development consultants.
• Sales and marketing expenses decreased by 8% for the three months and 7% for the six months ended June 30, 2025, due to lower discretionary payroll expense.

Negatives

• Revenue decreased significantly by 58% for the three months ended June 30, 2025, and 38% for the six months ended June 30, 2025, compared to the prior year periods, primarily due to short-term delays in completing two multiple-device sale contracts in the Americas region.
• Gross profit decreased by 69% for the three months and 43% for the six months ended June 30, 2025.
• Gross margin decreased to 40% for the three months and 48% for the six months ended June 30, 2025, from 53% in both prior periods, driven by fixed costs of goods, lower margin sales related to increased volume through distribution, and an increase in shipping costs.
• Loss from operations increased by 70% for the three months and 33% for the six months ended June 30, 2025.
• Net loss increased by 12% for the three months ended June 30, 2025.
• Accumulated deficit increased to $256.3 million as of June 30, 2025.
• Cash and restricted cash decreased to $5.2 million as of June 30, 2025, from $6.5 million at December 31, 2024.
• Unrestricted cash of approximately $3.2 million as of June 30, 2025, is estimated to fund operations only into the fourth quarter of 2025.
• Substantial doubt exists about the ability to continue as a going concern for at least 12 months from the issuance date of the financial statements.
• General and administrative expenses increased by 12% for the three months and 13% for the six months ended June 30, 2025, partly due to a $180,000 impairment loss on an intangible asset and higher legal and audit costs.
• The company had three customers with accounts receivable balances totaling 10% or more of total accounts receivable as of June 30, 2025 (15%, 14%, and 13%).
• During the three months ended June 30, 2025, three customers accounted for 10% or more of total revenue (18%, 13%, and 10%).
• During the six months ended June 30, 2025, one customer accounted for 14% of total revenue.

Risks

• Ability to obtain adequate financing to fund operations and develop or enhance technology.
• Ability to generate sufficient cash flow to service debt obligations.
• Ability to obtain or maintain regulatory approval to market medical devices.
• Ability to complete clinical trials on a timely basis and ensure completed clinical trials are sufficient to support commercialization.
• Uncertainty regarding the timing, cost, and progress of new product development and improvements, and related impacts on profitability and cash position.
• Ability to effectively market and sell products and expand business, both in unit sales and product diversification.
• Ability to achieve broad customer adoption of products and services.
• Existing or increased competition in the market.
• Accuracy of estimates regarding current or future addressable market.
• Ability to sell additional units and recognize expected margins and revenue using the reimbursement code for the Ekso Indego Personal device with CMS.
• Ability to obtain reimbursement from CMS in a timely manner and at expected reimbursement levels.
• Ability to obtain insurance coverage beyond CMS.
• Ability to obtain additional indications of use for devices.
• Rapid changes in technological solutions available to markets.
• Volatility within the business, including long and variable sales cycles, which could negatively impact quarterly results.
• Changes to domestic or international sales and operations.
• Ability to obtain or maintain patent protection for intellectual property.
• Scope, validity, and enforceability of intellectual property rights, both the company's and third-party.
• Significant government regulation of medical devices and the healthcare industry.
• Ability to receive regulatory clearance from certain government authorities, including any conditions, limitations, or restrictions placed on such approvals.
• Customers' ability to get third-party reimbursement for products and services, and the company's ability to manage the complex and lengthy reimbursement process.
• Potential for products to be subject to voluntary or involuntary recall.
• Product liability insurance may not adequately cover potential claims.
• Warrant claims and the accelerated maintenance program may result in additional operating costs.
• Failure to implement the business plan or strategies, including the expectation that CMS reimbursements will be a significant source of revenue.
• Ability to successfully consummate acquisitions on acceptable terms and to integrate any such acquisitions.
• Early termination of leases, difficulty filling vacancies, or negotiating improved lease terms.
• Ability to retain or attract key employees.
• Impacts of foreign currency price fluctuations.
• Overall economic and market conditions.
• Certain customers utilize federal funding, and recent federal policy changes have disrupted, and could continue to disrupt, that funding.
• Coverage policies and reimbursement levels of third-party payors, including Veteran's Administration, Medicare, Medicaid, and commercial payors, may impact sales growth of products.
• Dilution from future issuances of equity securities, including in future financings or strategic transactions, from compensatory equity awards and exercises of outstanding warrants, and the perception of such issuances, could depress the market price of common stock.
• Inability to achieve profitability in the near term or at all, and historical lack of profitability.
• Inability to reduce the cost to manufacture or service products as planned.
• Inability to continue as a going concern.
• Shortages in the materials used to manufacture products and supply chain disruptions, including as a result of changes in trade policies, could impact future results.
• International sales of products are subject to factors outside of control, such as local laws, protectionist practices, expense of facilities, language and cultural differences, legal regulations, foreign tax consequences, currency fluctuations, political and economic instability, and export/import restrictions.

Future Outlook

Management expects to aggressively increase CMS reimbursement submissions for the Ekso Indego Personal device once the process is optimized, anticipating that many of the approximately 45 qualified individuals will have their claims submitted by partners in 2025 and early 2026. The majority of 2025 revenue is still expected to come from Enterprise Health sales, but with Personal Health product sales contributing more quarter over quarter. The company believes Personal Health products have significant growth potential with expanded insurance coverage and indications of use. General commercialization for the Nomad product is expected to begin in 2026, subject to clinical and patient feedback. Unrestricted cash is estimated to fund operations into the fourth quarter of 2025, and the company expects to continue relying on external financing (equity and debt) to meet long-term cash requirements. If unable to secure sufficient additional financing, plans include delaying or abandoning certain product development projects, cost reduction efforts, and refocused sales efforts.

Management Comments

• "Management intends to raise funds through one or more financings in the near term in order to meet our cash requirements for the next 12 months."
• "We have concluded the likelihood that our plan to successfully reduce expenses to align with our available cash, while reasonably possible, is less than probable."
• "Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least 12 months from the date of issuance of these condensed consolidated financial statements."
• "Management currently estimates that the Company's unrestricted cash will fund its operations into the fourth quarter of 2025."
• "Once we have optimized this process [CMS reimbursement], we expect to more aggressively increase our CMS reimbursement submissions."
• "Given this ramp, we expect the majority of our revenue in 2025 will continue to come from Enterprise Health sales, but with Personal Health product sales contributing more quarter over quarter."
• "We believe that sales of our Personal Health products have the potential to be a significant growth driver for us as we work to gain coverage by other insurance providers, expand the products' indications of use beyond SCI and optimize our reimbursement submission processes."
• "Subject to clinical and patient feedback from clinical trials, we expect to begin the general commercialization process for Nomad in 2026."
• "We do not expect, nor do our historical operating results suggest, that cash flows generated from operations will be sufficient to meet our material cash requirements in the long term."
• "Management expects that our historical reliance on external financing, from both equity and debt financings, will continue to provide the capital necessary to meet our material cash requirements in the long term."

Industry Context

Ekso Bionics operates in the specialized healthcare exoskeleton market, serving physical rehabilitation and mobility needs for conditions like stroke, acquired brain injury, multiple sclerosis, and spinal cord injury, as well as industrial ergonomic challenges. The market demand is highly sensitive to awareness of robotic exoskeleton rehabilitation, the levels of third-party reimbursement (including from CMS and private insurers), and broader economic conditions. The recent CMS approval for the Ekso Indego Personal device's reimbursement is a critical development, potentially opening up a larger U.S. patient population, though the company is still refining its processes within this new reimbursement environment. The industry faces increasing price-based competition and cost containment initiatives from governmental and private payors, which could limit coverage and reimbursement for new products and impact pricing. Supply chain disruptions and changes in trade policies also pose ongoing challenges to manufacturing costs and operations.

Corporate Governance

Legal Proceedings

• Subject to various legal matters and claims arising in the ordinary course of business.
• Management believes the resolution of such matters will not have a material adverse effect on the condensed consolidated financial statements.
• The results of any litigation cannot be predicted with certainty, and an unfavorable resolution could materially affect future business, results of operations, or financial condition.
• Litigation can have an adverse impact due to defense and settlement costs, diversion of management resources, and other factors.

Related Party Transactions

• No related party transactions occurred during the six months ended June 30, 2025.
• A mutual release and settlement agreement with an entity affiliated with a board member, related to a July 2017 consulting agreement, was fully paid in April 2024 for a total settlement amount of $325,000.

Stakeholder Impact

• Shareholders face significant dilution risk from potential future equity issuances and a high risk of capital impairment due to the company's going concern issues and precarious financial health.
• Employees may be impacted by potential delays or abandonment of product development projects and cost reduction efforts if additional financing is not secured, affecting job security or growth opportunities.
• Customers may experience delays in product delivery due to supply chain issues, and their purchasing decisions could be affected by uncertain reimbursement policies.
• Patients and end-users stand to benefit from continued development and commercialization of exoskeleton products for improved physical rehabilitation and mobility, particularly those with spinal cord injuries.
• Suppliers and creditors face risks of delayed payments or the company's inability to fulfill obligations if severe liquidity issues persist.

Next Steps

• Complete two multiple-device sale contracts in the Americas region, expected to close in the third quarter of 2025.
• Optimize the CMS reimbursement process for Ekso Indego Personal.
• Aggressively increase CMS reimbursement submissions for Ekso Indego Personal once the process is optimized.
• Partners to submit claims for approximately 45 individuals believed to qualify for Ekso Indego Personal reimbursement in 2025 and early 2026.
• Continue to develop partnerships and pilots with other regional and national O&P suppliers.
• Ramp up direct marketing efforts and continue to grow a sales backlog for the Ekso Indego Personal device.
• Seek insurance coverage beyond CMS for Personal Health products.
• Seek additional indications of use for products.
• Begin general commercialization process for Nomad in 2026, subject to clinical and patient feedback.
• Raise additional funds through one or more financings in the near term.
• Potentially delay or abandon certain product development projects, implement cost reduction efforts, and refocus sales efforts if unable to secure sufficient financing.
• Actively monitor developments in trade policies and take necessary actions to mitigate risks from supply chain disruptions and tariffs.

Key Dates

Recommendation

The company faces severe liquidity challenges, explicitly stating "substantial doubt" about its ability to continue as a going concern. Revenue has significantly declined, gross margins are compressed, and operating losses are increasing. While there are positive developments in CMS reimbursement for a key product, the overall financial health is precarious, heavily reliant on uncertain future capital raises, and subject to significant dilution risk. The current financial position indicates a high risk of capital impairment, making it an unfavorable investment at this time.

Keywords

Exoskeleton, Medical Devices, Rehabilitation, Spinal Cord Injury, SCI, Ekso Indego Personal, EksoNR, Ekso Indego Therapy, Robotics, Healthcare Technology, Nasdaq, SEC Filing, 10-Q, Quarterly Report, Financial Results, Going Concern, CMS Reimbursement, Capital Raise, Warrant, Reverse Stock Split, Supply Chain, Intellectual Property, Biomedical Engineering