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Ekso Bionics(EKSO) - 2025 Q1 - Quarterly Report
2025-05-05 20:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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: 001-37854 Ekso Bionics Holdings, Inc. (Exact name of registrant as specified in its charter) Nevada 99-0367049 ...
Ekso Bionics(EKSO) - 2025 Q1 - Quarterly Results
2025-05-05 20:06
Exhibit 99.1 Ekso Bionics Announces First Quarter 2025 Financial Results SAN RAFAEL, Calif., May 5, 2025 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (Nasdaq: EKSO) ("Ekso Bionics" or the "Company"), an industry leader in exoskeleton technology for medical and industrial use, today reported financial results for the three months ended March 31, 2025. Recent Highlights and Accomplishments "Over the past few weeks, we have significantly expanded access to Ekso Indego Personal via potentially transformative ...
Ekso Bionics Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-05 20:05
SAN RAFAEL, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (Nasdaq: EKSO) (“Ekso Bionics” or the “Company”), an industry leader in exoskeleton technology for medical and industrial use, today reported financial results for the three months ended March 31, 2025. Recent Highlights and Accomplishments Strengthened financial position by improving operating cash burn by 43% combined with $3.8 million in net proceeds from the exercise of warrantsNamed National Seating & Mobility (“NSM”) as i ...
Ekso Bionics to Report First Quarter 2025 Financial Results on May 5 – Conference Call to Follow
Globenewswire· 2025-04-28 20:30
SAN RAFAEL, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (Nasdaq: EKSO) (the “Company”), an industry leader in exoskeleton technology for medical and industrial use, today announced that it will release financial and business results for the first quarter of 2025 after the close of trading on Monday, May 5, 2025. Management will host a conference call beginning at 1:30 p.m. PT / 4:30 p.m. ET to review the financial results and discuss recent business developments. To participate in ...
Bionic P&O Chosen as First Distributor of Ekso Indego® Personal Within the Orthotics & Prosthetics Industry
Globenewswire· 2025-04-23 12:16
Alliance marks Ekso Bionics’ first entrance into the O&P spaceSAN RAFAEL, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (Nasdaq: EKSO) (the “Company”), an industry leader in exoskeleton technology for medical and industrial use, today announced that it has named Bionic Prosthetics & Orthotics Group LLC (“Bionic P&O”), a leading national provider of prosthetic and orthotic solutions, as a non-exclusive Ekso Indego® Personal device distributor. Ekso Indego Personal is a wearable lower ...
Ekso Bionics(EKSO) - 2024 Q4 - Earnings Call Transcript
2025-03-04 02:44
Financial Data and Key Metrics Changes - The company recorded revenue of $5.1 million in Q4 2024, an increase of 5% compared to $4.8 million in Q4 2023 [13] - Gross profit for Q4 was $2.7 million, representing a gross margin of approximately 53%, up from a gross profit of $2.4 million and a gross margin of 49% in Q4 2023 [13] - Operating expenses for Q4 2024 were $4.9 million, a 15% decrease from $5.8 million in Q4 2023 [14] - Net loss applicable to common stockholders for Q4 was $3.4 million or $0.14 per share, compared to a net loss of $3.2 million or $0.22 per share in Q4 2023 [14] - Full year 2024 revenue was $17.9 million, down from $18.3 million in 2023 [15] - Full year gross profit was $9.5 million with a gross margin of approximately 53%, compared to $9.1 million and a gross margin of 50% in 2023 [17] - Full year net loss was $11.3 million or $0.56 per share, compared to a net loss of $15.2 million or $1.10 per share in 2023 [19] Business Line Data and Key Metrics Changes - The primary revenue source is from the sale and subscription of the Ekso NR device and the Ekso Indigo therapy device [10] - The company is focusing on expanding the personal health product line, particularly the Ekso Indigo Personal, which is expected to contribute to revenue growth starting in 2025 [31] Market Data and Key Metrics Changes - The company is experiencing growth in the APAC region, particularly with the Ekso NR and Indigo therapy devices [42] - Exceptional growth was noted in Europe, especially within the French hospital systems [44] Company Strategy and Development Direction - The company is shifting its focus to a scalable go-to-market strategy for the Ekso Indigo Personal, supported by partnerships with reimbursement services and market access firms [25][30] - Engaging Priya Healthcare for reimbursement services is seen as a critical move to navigate the complexities of Medicare claims [28] - The company aims to broaden access to the Ekso Indigo Personal through partnerships with National Seating and Mobility and other durable medical equipment suppliers [29][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in securing multi-unit orders in 2025 as procurement cycles return to normal for larger institutions [38] - The company anticipates meaningful growth in claims submissions for Medicare beneficiaries in 2025, with a current pipeline of about twenty-five individuals [39] - Management is optimistic about the overall commercial traction expected in both enterprise and personal markets in 2025 [76] Other Important Information - The company had cash and restricted cash of $6.5 million as of December 31, 2024 [19] Q&A Session Summary Question: Confidence in securing multi-unit orders and volume of Indigo claims - Management expects more multi-unit orders in 2025 and plans to submit claims for about twenty-five individuals this year [38][39] Question: Growth trajectory in Europe and APAC regions - Management projects continued growth in APAC and a return to normal growth rates in Europe after exceptional growth in 2024 [42][44] Question: Patient interest generated via marketing activities - A large number of leads are being processed, with a focus on individuals with spinal cord injuries who meet health requirements [50] Question: Relationship with National Seating and Mobility - The partnership aims to leverage NSM's expertise in the complex rehabilitation technology industry to enhance distribution and reimbursement processes [70]
Ekso Bionics(EKSO) - 2024 Q4 - Annual Report
2025-03-03 21:08
Product Development and Market Strategy - The company designs, develops, and markets exoskeleton products primarily for the healthcare sector, targeting individuals with physical disabilities [14]. - The company operates in two markets: Enterprise Health and Personal Health, generating revenue through device sales and subscription services [24]. - The company continues to explore business development initiatives to fuel growth and long-term value through technology and advanced rehabilitative programs [15]. - The company is developing a scalable go-to-market strategy by building relationships with national and regional Durable Medical Equipment suppliers (DMEs) [36]. - The company aims to expand insurance coverage beyond CMS and seek additional indications of use for its products, which could drive significant growth [36]. - The company continues to invest in research and development to enhance product offerings in the exoskeleton market, responding to evolving demands [121]. Regulatory and Compliance Challenges - The company is subject to various foreign regulations governing clinical trials and commercial sales, which vary significantly by country [65]. - Regulatory compliance costs may increase due to potential changes in FDA policies and foreign regulatory authorities, impacting product approval timelines [71]. - The process of obtaining FDA approval for medical devices can take from several months to over a year for 510(k) clearance and from one to three years or longer for PMA, with PMA generally requiring clinical trials [162]. - Non-compliance with regulatory requirements can lead to severe sanctions, including product recalls, fines, and suspension of manufacturing operations [165]. - The FDA's new QMSR will be enforced starting February 2, 2026, replacing the existing QSR, which may increase compliance costs and operational disruptions [183]. - The company must report adverse events and production problems to the FDA and may face significant penalties for non-compliance with post-market regulatory requirements [169]. Financial Performance and Funding - The company has incurred significant losses to date and anticipates continuing to incur losses in the future, raising concerns about achieving profitability [102]. - The company has significant cash outlays required to support operations and remains largely dependent on capital raised from past and future financings to implement its business plan [139]. - As of December 31, 2024, the company had cash and restricted cash of $6.5 million, which is not sufficient to fund operations for the next 12 months without substantial revenue increases [146]. - The company is seeking additional financing and evaluating alternatives to meet cash requirements for the next 12 months, with uncertainty regarding the availability of such capital [147]. - The company’s current sales and marketing, research and development, and general and administrative expenses are higher as a percentage of sales than needed for profitability, which may hinder margin improvement [148]. Market Opportunities and Reimbursement - In April 2024, CMS approved a reimbursement payment level of approximately $91,000 for the Ekso Indego Personal, effective April 1, 2024, potentially increasing demand among Medicare enrollees with spinal cord injuries (SCI) [36]. - Approximately 57% of individuals with SCI are enrolled in Medicare or Medicaid within five years post-injury, indicating a significant market opportunity for the Ekso Indego Personal [36]. - The reimbursement policy allows individual users who meet FDA-approved indications to purchase the Ekso Indego Personal through authorized DMEs and receive 80% reimbursement of the applicable rate [43]. - The company has faced challenges in the reimbursement process for its Personal Health products, with the first CMS reimbursement claim submitted in May 2024 and reimbursed in July 2024 [104]. - The company anticipates submitting approximately 25 claims for reimbursement to CMS over the next six to nine months [104]. Competition and Market Position - The company faces competition in the medical technology and industrial robotics industries, particularly in exoskeleton technology, which is still in its early stages [72]. - For Enterprise Health products, competition primarily comes from traditional non-robotic therapy by licensed physical therapists and other mechanical or robotic therapy devices [73]. - Personal Health products compete mainly with manual or powered wheelchairs and other traditional mobility aids, with clinical evidence supporting better outcomes for certain users [74]. - The commercial success of the company’s products will depend on adequate reimbursement levels established by governmental and private payers [60]. Intellectual Property and Licensing - The company has established an extensive intellectual property portfolio with 77 issued U.S. patents and 5 pending applications as of December 31, 2024 [81]. - The patent portfolio includes technologies relevant to medical and commercial exoskeletons, with the earliest priority date reaching back to 2003 [83]. - The company entered a license agreement with Vanderbilt University, paying a $100,000 fee and agreeing to royalties of 3.75% on net sales, with minimum annual royalties starting at $75,000 in 2027 [90]. Operational Risks and Challenges - Supply chain disruptions and material shortages, particularly in electronic components and battery cells, may negatively impact the company's future results [112][113]. - The company faces intense competition in the medical devices and industrial robotics markets, which may affect its market position and financial performance [106]. - Future trade policies and potential tariff increases may require the company to adjust sourcing strategies, which could incur substantial costs and operational challenges [114]. - The company faces challenges in reducing manufacturing costs and maintaining high service standards for its products [137]. Employee and Workforce Relations - As of February 28, 2025, the company had 61 full-time employees and five part-time employees, with a good relationship with its workforce [97].
Ekso Bionics(EKSO) - 2024 Q4 - Annual Results
2025-03-03 21:06
Financial Performance - Total revenue for Q4 2024 is estimated to be in the range of $5.0 million to $5.1 million, a record for the company, compared to $4.8 million in Q4 2023[9] - The company used an estimated $1.5 million of net cash in operations for Q4 2024, compared to $1.6 million for the same period in 2023[9] Cash Position - Estimated cash as of December 31, 2024, was $6.5 million, down from $8.6 million as of December 31, 2023[9]
Ekso Bionics Reports Fourth Quarter and Full-Year 2024 Financial Results
Globenewswire· 2025-03-03 21:05
Core Viewpoint - Ekso Bionics Holdings, Inc. reported record revenue for the fourth quarter of 2024, with a focus on expanding patient access and increasing demand for its exoskeleton devices [2][11]. Summary of Fourth Quarter 2024 Financial Results - The company recorded revenue of $5.1 million for Q4 2024, a 5% increase from $4.8 million in Q4 2023 [3]. - Gross profit for Q4 2024 was $2.7 million, up 15% from the previous year, resulting in a gross margin of approximately 53%, compared to 49% in Q4 2023 [4]. - Sales and marketing expenses decreased to $1.9 million from $2.0 million in Q4 2023, attributed to lower headcount and discretionary payroll [5]. - Research and development expenses for Q4 2024 were $845,000, down from $1.3 million in Q4 2023, due to reduced discretionary payroll and consultant costs [5]. - General and administrative expenses fell to $2.2 million from $2.5 million in Q4 2023, primarily due to lower discretionary payroll [6]. - The net loss for Q4 2024 was $3.4 million, or $0.14 per share, compared to a net loss of $3.2 million, or $0.22 per share, in Q4 2023 [6]. Summary of Full Year 2024 Financial Results - For the full year 2024, the company reported revenue of $17.9 million, a 2% decrease from $18.3 million in 2023 [8]. - Gross profit for the full year was $9.5 million, with a gross margin of approximately 53%, compared to $9.1 million and a 50% margin in 2023 [9]. - Sales and marketing expenses for the full year decreased to $7.3 million from $8.5 million in 2023 [10]. - Research and development expenses for the full year were $3.9 million, down from $5.0 million in 2023 [12]. - General and administrative expenses for the full year were $8.8 million, compared to $10.7 million in 2023 [13]. - The net loss for the full year was $11.3 million, or $0.56 per share, a 25% improvement from a net loss of $15.2 million, or $1.10 per share, in 2023 [13]. - The company used $9.8 million of net cash in operations for the full year, down from $12.1 million in 2023 [14]. Additional Highlights - The company named National Seating & Mobility as its exclusive distributor for the Ekso Indego Personal device in the U.S. complex rehabilitation technology industry [11]. - As of December 31, 2024, the company had cash and restricted cash of $6.5 million [14].
Ekso Bionics to Report Fourth Quarter and Full Year 2024 Financial Results on March 3 – Conference Call to Follow
Globenewswire· 2025-02-24 21:30
Core Insights - Ekso Bionics Holdings, Inc. will release its financial and business results for Q4 and full year 2024 on March 3, 2025, after market close [1] - A conference call will be held at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results and recent business developments [1] Company Overview - Ekso Bionics is a leading developer of exoskeleton solutions aimed at enhancing human strength, endurance, and mobility for both medical and industrial applications [3] - The company was founded in 2005 and is recognized for its innovative wearable robots, which assist individuals with paralysis and enhance capabilities in various job sites [3] - Ekso Bionics is headquartered in the San Francisco Bay Area and is publicly traded on the Nasdaq under the symbol "EKSO" [3]