Financial Data and Key Metrics Changes - Revenue for Q4 2023 totaled $7 million, a 27% increase compared to $5.5 million for the same period in 2022, slightly exceeding previous guidance of 20% to 24% growth [11] - Fiscal year 2023 revenue reached $20.4 million, up 22% from $16.7 million in 2022 [11] - Gross margin for Q4 2023 was 69.1%, down from 78.1% in Q4 2022, primarily due to non-recurring inventory write-offs [12] - Adjusted EBITDA for Q4 2023 was $700,000, an improvement of $2 million from negative $1.3 million in Q4 2022 [13] Business Line Data and Key Metrics Changes - Ultramist systems sold increased by 44% from Q3 2023, with total placements for the quarter reaching 98, compared to 55 in Q3 [6] - Applicators revenue grew by 16% sequentially, accounting for 51% of overall revenues in the quarter [7] - The number of active systems in the field rose by 14% sequentially, indicating strong growth in the core business [9] Market Data and Key Metrics Changes - The company is focusing on expanding its user base, with 47% of systems sold in Q4 2023 going to new customers [7] - The company is targeting high usage environments and physician practices to increase applicator usage per active system [10] Company Strategy and Development Direction - The company aims to improve operational profitability and manage expenses while expanding its commercial operations and clinical training teams [10] - A merger with SEPA is ongoing, which is expected to simplify the capital structure and eliminate complexities in financial reporting [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2024 as a breakout year, expecting revenue growth of 50% compared to 2023, with revenues projected to exceed $30 million [18] - Gross margins are anticipated to recover to the mid-seventies range in 2024 [17] Other Important Information - Total current assets as of December 31, 2023, were $9.8 million, up from $6.6 million a year earlier [13] - Cash totaled $1.8 million as of December 31, 2023 [13] Q&A Session Summary Question: Status of patents and talks with Shockwave - Management confirmed an intellectual property deal was announced earlier in the month, emphasizing the value of its intellectual property portfolio [22] Question: Timeline for the merger and listing - Management indicated that finalizing the exchange listing depends on factors outside their control, but they hope it will not take long [26] Question: Legal matters regarding the merger - Management clarified that there are no legal matters holding up the merger, only the completion of pro forma SEC filings [31] Question: Contact for doctors interested in trials - Interested parties can contact Tim Hendrix, the head of sales, through the company's website for product trials [32]

Merger and Financial Condition - The Company has entered into a Merger Agreement with SEP Acquisition Corp., which will result in the issuance of 7,793,000 shares of Class A Common Stock of SEPA to holders of Company common stock and other securities[17]. - Approximately 95% of outstanding warrants and 100% of convertible notes have committed to exchange for an aggregate of 1,217,222,186 shares and 219,841,980 shares of common stock, respectively, prior to the Closing[18]. - The Merger Agreement includes a Minimum Cash Condition of at least $12,000,000, which must be satisfied for the Business Combination to be consummated[93]. - SEPA Stockholders elected to redeem 495,067 shares of Class A Common Stock, necessitating PIPE Investment to satisfy the Minimum Cash Condition[94]. - As of the filing date, no commitments have been made for the proposed financing from the PIPE Investment, creating uncertainty regarding the amount raised[95]. - The company is required to raise additional funds to finance operations and remain a going concern, indicating substantial doubt about its ability to continue for at least twelve months from the filing date[111]. - The company has a history of losses, raising concerns about the Combined Company's ability to achieve or maintain profitability[106]. - The company incurred a net loss of $25.8 million and $10.3 million for the years ended December 31, 2023, and 2022, respectively[112]. - The operating loss was reduced by 94% to $0.5 million for the year ended December 31, 2023, compared to $9.0 million in 2022[209]. - The net loss for 2023 was $25.8 million, or ($0.03) per share, compared to a net loss of $10.3 million, or ($0.02) per share, in 2022[209]. - Management aims to secure additional capital in early 2024 primarily through the merger, but current private placements restrict the ability to incur new debt[116][123]. Product Development and Technology - The dermaPACE system has received FDA approval and is aimed at treating diabetic foot ulcers, which are a leading cause of hospitalization among diabetic patients, leading to billions in healthcare expenditures annually[24]. - The UltraMIST system is FDA approved for treating various wound types, including diabetic foot ulcers and pressure ulcers, by promoting healing below the skin surface[21]. - The PACE technology is designed to activate healing through acoustic pressure shockwaves, promoting angiogenesis and tissue regeneration[22]. - The Company is focused on the commercialization of its patented, non-invasive medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures[27]. - The Company has established a network of scientific advisors to assist in clinical and pre-clinical study design and product development[28]. - The Company has a manufacturing supply agreement with Minnetronix Medical for the generator and treatment wand components, ensuring compliance with quality standards[33]. - The Company’s facility in Eden Prairie, MN is FDA registered and ISO 13485:2016 certified, providing office, product development, quality control, and warehouse space[36]. - The company entered into a license agreement with HealthTronics in August 2005, acquiring certain assets and intellectual property related to orthopedic and other medical conditions[40]. - In August 2020, the company acquired all assets related to the MIST Therapy System and UltraMIST System from Celularity, including intellectual property and trademarks[44]. - The company has a perpetual, non-exclusive and royalty-free license to nine issued foreign patents, with some patents expiring as late as 2038[43][49]. - The company holds a diverse patent portfolio, including shockwave devices and ultrasound technologies, with expiration dates extending into the 2040s[48][52]. Regulatory Compliance and Risks - Medical devices require FDA authorization prior to marketing, either through a 510(k) clearance or a PMA approval, with 510(k) submissions needing to demonstrate substantial equivalence to legally marketed devices[65]. - The company must comply with extensive post-approval regulations, including quality systems regulation and specific controls based on device classification[68]. - The company is subject to various international regulations and product registration requirements, which may differ significantly from FDA requirements[75]. - The company is registered as a Small Business Manufacturer with the FDA, which subjects it to reduced fees; however, exceeding a certain revenue threshold may result in losing this status[67]. - The company is subject to extensive governmental regulation, including FDA approval, which could affect the commercialization of its products[106]. - The company faces significant transaction and transition costs related to the Business Combination, which may impact future financial performance[103]. - The company is subject to periodic reviews and audits from governmental and private payors, which could result in significant costs and adverse effects on business operations[157]. - Regulatory compliance is extensive, with potential consequences including fines, product recalls, and operational restrictions[139][140]. - The company anticipates increased operational costs due to compliance with HIPAA regulations as it expands its business[155][156]. - The company may face increased restrictions on reimbursement for its products, impacting market acceptance and future revenues[146]. - Non-compliance with the Federal Anti-Kickback Statute and False Claims Act could lead to severe penalties and exclusion from federal healthcare programs[151][152]. Competition and Market Environment - The advanced wound care market is competitive, with major players including Acelity and Organogenesis, but the company believes its PACE technology offers superior value[58]. - The company faces competition from various companies in the extracorporeal shockwave device market, but believes its PACE systems have a competitive advantage[59]. - The medical device industry is highly competitive, with significant risks from established companies with greater resources and rapid technological changes[126]. - The company may seek to expand operations through acquisitions, which would likely increase capital requirements[125]. - Less than 5% of the company's revenue comes from international sources, with no current plans for significant international expansion[137]. Financial Performance and Stock Information - The company achieved a revenue growth of 22%, reaching $20.4 million for the year ended December 31, 2023, compared to $16.7 million in 2022[208]. - Gross margins decreased to 70% in 2023 from 74% in 2022[208]. - The company has not paid dividends in 2023 or 2022 and does not anticipate paying any in the foreseeable future[205]. - As of December 31, 2023, there were 1,140,559,527 shares of common stock outstanding[204]. - The stock price is volatile, influenced by operating results, financing ability, and market fluctuations[178]. - There is currently a limited trading market for the company's common stock, affecting liquidity[181]. Internal Controls and Cybersecurity - The Company has identified material weaknesses in internal controls over financial reporting, which could lead to misstatements in financial statements if not remediated[119][120]. - The company has experienced cybersecurity breaches, including email spoofing, despite investments in data protection[135]. - The company has not experienced any material cybersecurity breaches, but acknowledges potential future risks[196]. - The company relies heavily on information technology systems, facing risks from cybersecurity breaches and data leakage[134]. Supply Chain and Operational Risks - The company faces supply chain risks, as many product components are sourced from single suppliers, which could disrupt production if issues arise[127][128]. - There are potential liabilities from product use that could result in financial loss, with current insurance coverage possibly insufficient to cover claims[133]. - The company may incur significant costs due to compliance with federal, state, and local environmental laws and regulations[159]. - The company faces potential liabilities related to the use of hazardous materials in its operations, which could exceed its resources[159].

Sanuwave Health (SNWV) FY 2024 Annual General Meeting February 21, 2024 11:00 AM ET Speaker0 Good morning, ladies and gentlemen. Welcome, and thank you for attending this special meeting of stockholders of SANUWAVE Health Inc. Throughout this meeting, I will refer to SANUWAVE Health Inc, either as SANUWAVE or as the company. This meeting will please come to order. My name is Morgan Frank, chief executive officer of SANUWAVE. I will act as chairman of the meeting, and Tony Reno, the chief financial officer a ...

Financial Data and Key Metrics Changes - Revenue for Q3 2023 totaled $5 million, an increase of 19% compared to $4.2 million for the same period in 2022, falling within the guidance range of 15% to 25% [11] - Gross margin for Q3 2023 was 71%, slightly down from 72% in the same period last year [11][12] - Operating loss for Q3 2023 was $500,000, an improvement of $2 million compared to the same period last year [12] - Net loss for Q3 2023 was $23.7 million, compared to a net loss of $1.1 million for the same period in 2022, primarily due to noncash losses on derivative liabilities [13] Business Line Data and Key Metrics Changes - 55 UltraMist units were sold in Q3 2023, with over 40% of those sales to new customers [17] - Ultramist revenues grew over 25% year-on-year in Q3 2023, with consumables revenue growing 11% from Q2 and 24% compared to Q3 2022 [22] - Consumables for Ultramist constituted 62% of overall revenues in the quarter [22] Market Data and Key Metrics Changes - The company ended Q3 2023 with 581 active systems in the field, up from 526 at the end of Q2 [22] - The company is focusing on engaging new customers, particularly in busy practices with high utilization rates [21] Company Strategy and Development Direction - The company is developing a new business model allowing customers to bundle payments for UltraMist into a monthly operating cost, which is expected to generate predictable recurring revenue [7][9] - The company aims to increase production capacity for systems to two to three times the 2023 levels in 2024 [39] - The merger with Sweat Equity Partners is anticipated to enhance capital and capabilities, with plans to move to NASDAQ [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about eliminating production constraints and achieving a stable manufacturing cadence of double-digit rates per week [5] - The company anticipates revenue growth in the range of 15% to 25% for Q4 2023, with no significant production capacity constraints expected [25] Other Important Information - The company closed an additional financing round in July 2023, raising approximately $3 million to support operations [13] - Management emphasized the importance of pricing discipline and the positive market response to it [18] Q&A Session Summary Question: What is the state of dermaPACE and its future? - Management indicated that dermaPACE was slow in Q3 and is currently assessing its direction, focusing on international channels and potential long-term studies for reimbursement [28][30] Question: Update on merger approval and potential hurdles? - Management stated that they filed an amended S-4 and are awaiting SEC comments, with a good chance of closing the deal this year [32][34] Question: Capacity for devices and applicators going forward? - Management confirmed that production capacity has reached a double-digit cadence weekly and plans to significantly increase capacity in 2024, including redesigning applicators for better manufacturability [39][40]

Financial Performance - Total revenue for Q3 2023 was $4,953,000, representing a 19% increase from $4,166,000 in Q3 2022[18] - Gross margin improved to $3,541,000 in Q3 2023, up from $3,009,000 in Q3 2022, indicating a stronger operational efficiency[18] - Operating loss decreased to $531,000 in Q3 2023 compared to $2,485,000 in Q3 2022, reflecting improved cost management[18] - Net loss for Q3 2023 was $23,700,000, significantly higher than the $1,139,000 loss in Q3 2022, primarily due to increased interest expenses and changes in fair value of derivative liabilities[18] - For the nine months ended September 30, 2023, the company reported a net loss of $44,042,000, compared to a net loss of $4,596,000 for the same period in 2022[27] - Net cash used in operating activities was $3,253,000, a significant improvement from $13,176,000 in the prior year[27] - The company reported a basic and diluted loss per share of $0.03 for Q3 2023, compared to a loss of $0.00 in Q3 2022[18] - EBITDA for the three months ended September 30, 2023, was $(19.589) million, compared to $2.917 million in the same period of 2022[96] - Adjusted EBITDA for the three months ended September 30, 2023, was $(0.264) million, compared to $(2.249) million in the same period of 2022[96] Assets and Liabilities - Total current assets increased to $7,394,000 as of September 30, 2023, compared to $6,620,000 at the end of 2022, driven by higher inventory levels[14] - Total liabilities rose to $86,296,000 as of September 30, 2023, up from $60,883,000 at the end of 2022, largely due to increased senior secured debt[14] - The company’s accumulated deficit increased to $238,284,000 as of September 30, 2023, compared to $194,242,000 at the end of 2022[16] - Cash balance decreased to $1,095,000 as of September 30, 2023, down from $1,153,000 at the end of 2022, indicating liquidity challenges[14] Shareholder Information - The number of shares outstanding increased to 1,026,078,464 as of September 30, 2023, from 548,737,651 at the end of 2022, reflecting shares issued for debt settlement[21] - The merger agreement involves SEPA acquiring 100% of the company's issued and outstanding equity securities, with the company's stockholders expected to hold approximately 69-70% of the combined company[47] - The merger consideration will consist of 7,793,000 shares of Class A Common Stock, allocated pro rata based on ownership after the conversion of outstanding convertible notes[48] Merger and Capital Resources - The company expects to devote substantial resources for the commercialization of UltraMIST and PACE systems, which will require additional capital resources[34] - The company plans to obtain additional capital primarily through closing a merger, which is expected to provide necessary funding[35] - The company has deferred $732,000 in merger costs until the closing of the merger[44] - Management plans to obtain additional capital primarily through the closure of the merger, which is expected to add approximately $12 million of additional capital[107] - The Merger Agreement includes a Minimum Cash Condition of $12 million, which must be satisfied for the Business Combination to be completed[130] Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting as of September 30, 2023, which management is actively working to remediate[120] - The company is working with an external vendor to improve internal controls and ensure compliance with U.S. GAAP[121] - The company has not made any changes to its internal control over financial reporting that materially affect its operations during the quarter ended September 30, 2023[126] Risks and Uncertainties - The company faces risks related to the Business Combination, including conditions that may not be satisfied in a timely manner[129] - The company cannot assure that the shares of the Combined Company's Class A Common Stock will be approved for listing on Nasdaq following the Closing[137] - The Combined Company must maintain a minimum market capitalization of $50,000,000 and at least 300 public shareholders to continue listing on Nasdaq[138] - Significant transaction and transition costs are expected due to the Business Combination, including legal, accounting, and consulting fees, which will be paid by the Combined Company after closing[141] - Uncertainty surrounding the Business Combination may disrupt relationships with customers, suppliers, and business partners, potentially affecting future operations[139] - The Company is subject to contractual restrictions that may limit its ability to pursue business opportunities until the Business Combination is completed[140] - There is a risk that employees may experience uncertainty about their future roles, impacting the ability to retain and hire key personnel[143] Expenses and Financial Management - General and administrative expenses decreased by $0.8 million or 23% for the three months ended September 30, 2023, compared to the same period in 2022[101] - Selling and marketing expenses decreased by $0.6 million or 37% for the three months ended September 30, 2023, compared to the same period in 2022[102] - Other expense, net increased by $24.5 million to $23.2 million for the three months ended September 30, 2023, compared to the same period for 2022[105] - Cash provided by financing activities was $3.4 million for the nine months ended September 30, 2023, primarily due to new bridge notes payable and convertible lending activities[109]

Financial Data and Key Metrics Changes - Revenue for Q2 2023 totaled $4.7 million, a 20% increase compared to $3.9 million in Q2 2022, falling within the guidance range of 15% to 25% [8] - Gross margins increased to 74% in Q2 2023 from 72% in the same period last year, primarily due to stronger pricing initiatives [9] - Operating income improved to $1 million in Q2 2023, aligning with the initiative to drive profitable growth [10] - Net loss for Q2 2023 was $7.3 million, compared to a net income of $1.6 million in Q2 2022, primarily due to noncash losses on derivative liabilities [10] - Adjusted EBITDA for Q2 2023 was $171,000, compared to negative $1.9 million in the prior year period [11] Business Line Data and Key Metrics Changes - The company is focusing on consumables, with Ultramist consumables accounting for 59% of overall revenues in Q2 [17] - The attach rate, which measures the number of active systems in the field and their consumable usage, is expected to rise significantly in future years [20] Market Data and Key Metrics Changes - Fastest growing sales channels are private offices, nursing homes, and mobile wound care groups, indicating a shift towards treating patients outside of hospitals [13] - Proposed changes by Medicare contractors could significantly impact the marketplace for advanced skin substitutes, potentially benefiting Ultramist as a viable treatment option [14] Company Strategy and Development Direction - The company aims for rapid profitable growth and to create a self-sustaining business model, reducing reliance on capital markets [7] - Key hires and partnerships, such as with Pacific Medical, are intended to expand market reach and professionalize operations [6][15] Management's Comments on Operating Environment and Future Outlook - Management anticipates revenue growth of 15% to 25% year-over-year for Q3 2023, despite production capacity constraints [22] - The company is optimistic about the future of the wound care market and is focused on increasing the number of active systems and consumables revenue [23] Other Important Information - Total current assets as of June 30, 2023, were $6.1 million, down from $6.6 million at the end of 2022 [11] - The company closed an additional financing round in July 2023, raising approximately $3 million to support operations [11] Q&A Session Summary Question: Comments on the dermaPACE product - Management stated that dermaPACE units are still being sold actively, but it represents a small portion of revenue, with a renewed focus expected in coming quarters [26][27]

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, 2023 For the transition period from ________ to Commission File Number 000-52985 SANUWAVE Health, Inc. (Exact name of registrant as specified in its charter) Nevada 20-1176000 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 11495 Valley ...

Financial Data and Key Metrics Changes - In Q1 2023, revenue amounted to $3.8 million, representing an 18% increase compared to the same period last year, aligning with the guidance of 14% to 20% growth [9][10] - Gross margin decreased to 67% in Q1 2023 from 72% in Q1 2022 due to cost increases associated with servicing refurbished equipment [7][10] - Operating expenses increased by 4.7% year over year, totaling $4.5 million, primarily due to higher general and administrative expenses [9][10] Business Line Data and Key Metrics Changes - The number of treatments reached a record 43,000 in Q1 2023, indicating continued adoption of Ultramist [7] - Units shipped achieved the highest level for the first quarter in company history, reflecting robust demand despite supply chain challenges [7] Market Data and Key Metrics Changes - Demand for products remains strong, with over 20 new accounts added to the pipeline following recent conferences [6] - The company is on track to receive over 400 devices in 2023, compared to 217 sold last year, although it is uncertain if all will be sold [5] Company Strategy and Development Direction - The company is focused on addressing supply chain issues to balance supply and demand, with initiatives aimed at improving automation and reducing costs [8][16] - Management plans to leverage existing infrastructure for profitable growth and aims to achieve record revenue growth and profitability in 2023 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming supply constraints, indicating that the issues are primarily related to Ultramist production [23] - The company anticipates revenue growth of 15% to 25% in Q2 2023, contingent on supply chain improvements [15] Other Important Information - The company closed an additional private placement in May 2023, raising $1.2 million to support operations [10] - Management emphasized the importance of strong reimbursement channels for Ultramist across various service settings, enhancing market opportunities [20] Q&A Session Summary Question: Can you expand on the reimbursement situation for Ultramist? - Ultramist has strong reimbursement in multiple settings, including hospitals, private offices, home health, assisted living facilities, and nursing homes, providing diverse channels for growth [20] Question: Are the supply constraints expected to be prolonged? - Supply constraints are primarily around Ultrimist, but management is confident that these issues will not last a year and are working to ensure a consistent supply [23] Question: Will operating cost increases be a recurring issue? - The increase in operating costs is largely due to one-time professional service fees related to SEC initiatives, and overall operating expenses are increasing at a slower rate compared to revenue [29]

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 March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification ...

Financial Data and Key Metrics Changes - Q4 2022 revenues amounted to $5,500,000, representing a 29% increase year-over-year [13] - Total revenues for the twelve months ending 12/31/2022 reached $16,700,000, an increase of 28.7% year-over-year [13] - Gross margins improved to 75% for 2022 compared to 62% for 2021, with Q4 gross margins reaching 78% [13] - Operating expenses for 2022 decreased by 4% year-over-year, while Q4 operating expenses increased by 9% [14] Business Line Data and Key Metrics Changes - The company achieved record levels in units shipped and treatments, driven by the adoption of Ultramist [6] - Operating expenses decreased year-over-year due to automation and reduced headcount [6] Market Data and Key Metrics Changes - The chronic wound care market is valued at $45 billion, with SANUWAVE positioned favorably due to strong clinical evidence and reimbursement support [5] - The biological skin substitute market is experiencing turmoil, with reimbursement cuts expected to reach 80-90% by next year [18] Company Strategy and Development Direction - The company aims for sustainable, profitable growth in 2023, focusing on leveraging existing infrastructure [8] - Plans to enhance investor relations and marketing strategies to increase awareness and adoption of products [17] - Participation in industry trade shows to promote products and educate potential customers [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the supply chain but expressed optimism about achieving record revenue growth and profitability in 2023 [21] - Anticipated first-quarter revenue growth of 14-20% year-over-year, with expectations for acceleration in Q2 [22] Other Important Information - The company successfully relisted on the OTCQB on January 30, 2023, after addressing accounting issues [8] - Key additions to the management team were made to drive profitable growth [10] Q&A Session Summary Question: What might peak production look like in the next couple of quarters? - The company is currently at a pace of 40 new products per month, scheduled to ramp to 100 by the end of the year [29] - The applicator side is running 20% ahead of demand, with plans to increase production by 70-80% by year-end [31]