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Financial Data and Key Metrics Changes - Q3 2025 was an all-time record revenue quarter for the company, with revenue reaching $11.5 million, up 22% year-over-year and 13% sequentially from Q2 [4][12] - Year-to-date revenue growth for the first nine months of 2025 was 39% compared to the same period last year [4] - Gross margins were 77.9%, slightly down from 78.2% in Q2 but up from 75.5% a year ago [5][13] - Net income for Q3 2025 was $10.3 million, compared to a net loss of $20.7 million for the same period in 2024, representing a $31 million increase [15] Business Line Data and Key Metrics Changes - The company sold 155 Ultimate Systems in Q3, an increase from 124 units sold in the same quarter last year [4] - Applicator revenue reached $6.8 million, up 26% year-over-year and 6% sequentially from Q2 [4] Market Data and Key Metrics Changes - The wound care market experienced uncertainty in Q3 due to changes in reimbursement policies, leading to a cautious approach from practitioners [8][9] - Despite the uncertainty, the company’s reimbursement for the 97610 code remains largely unchanged, potentially slightly increasing for 2026 [8] Company Strategy and Development Direction - The company is focused on driving sustainable, profitable growth and is optimistic about future opportunities as market concerns around reimbursement are alleviating [18] - The company is exploring a rental model for hospitals to navigate capital approval processes, which could enhance market penetration [55] Management's Comments on Operating Environment and Future Outlook - Management noted that the recent changes in reimbursement rules have created a more favorable environment for the company, leading to increased inbound interest from distributors and partners [10][66] - The company is engaged with a promising sales funnel and anticipates significant opportunities in the coming months [11] Other Important Information - The company received a $5 million payment for the exercise of IP licensing related to its intravascular shockwave patent portfolio [7] - The company refinanced its debt, reducing it from $27.5 million to $24 million, which has improved its financial footing [7] Q&A Session Summary Question: Is there inbound interest from resellers due to disruption in skin substitutes? - Yes, there is substantial inbound interest as resellers are looking to realign their offerings in light of significant changes in the market [21][22] Question: How does the company blend distributor channels with direct sales? - The company employs a deconflicting structure to ensure that direct sales and distributor efforts do not overlap [25] Question: What is the current rep headcount and future plans? - The rep headcount remains at 13, with plans to grow based on market conditions and internal assessments [30][34] Question: How does the company handle inventory management with distributors? - The company is cautious about inventory levels in the channel and aims to maintain healthy inventory turns [26] Question: What is the company's approach to international opportunities? - While there is interest in international distribution, the current focus remains on domestic opportunities due to the significant potential in the U.S. market [38] Question: How does the CMS fixed rate affect Ultramist's attractiveness? - The attractiveness of Ultramist has increased as physicians seek to maximize revenue while providing patient care [42] Question: What is the company's strategy regarding capital approval processes in hospitals? - The company is considering a rental model to facilitate easier access to its products in hospitals with strict capital budgets [55]

Core Viewpoint - Sanuwave Health Inc. reported quarterly earnings of $0.46 per share, exceeding the Zacks Consensus Estimate of $0.32 per share, and showing a significant improvement from a loss of $6.49 per share a year ago [1] Financial Performance - The company achieved revenues of $11.45 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 0.18%, and up from $9.36 million in the same quarter last year [2] - Over the last four quarters, Sanuwave Health has exceeded consensus EPS estimates two times and topped consensus revenue estimates twice [2] Stock Performance - Sanuwave Health shares have increased approximately 14.8% since the beginning of the year, compared to a 14.3% gain in the S&P 500 [3] Future Outlook - The company's earnings outlook will be crucial for investors, with current consensus EPS estimates at $0.20 for the coming quarter and $0.34 for the current fiscal year, alongside projected revenues of $13.5 million and $44.44 million respectively [7] - The estimate revisions trend for Sanuwave Health was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Products industry, to which Sanuwave Health belongs, is currently ranked in the bottom 35% of over 250 Zacks industries, suggesting potential challenges ahead [8]

Financial Performance - Q3 2025 revenues reached $11.5 million, a 22% increase from $9.4 million in Q3 2024, marking the highest quarterly revenues in company history [2][7] - Gross margin for Q3 2025 was 77.9%, up from 75.5% in Q3 2024 [3][22] - Operating income for Q3 2025 was $1.5 million, down from $2.0 million in Q3 2024, impacted by $1.4 million in stock-based compensation costs [4][22] - Net income for Q3 2025 was $10.3 million, compared to a net loss of $20.7 million in Q3 2024, primarily due to a non-cash gain of $6.1 million from derivative liabilities [7][22] - Adjusted EBITDA for Q3 2025 was $3.5 million, compared to $2.1 million in Q3 2024 [7][24] - Operating income for the nine months ended September 30, 2025, was $4,330,000, compared to $2,895,000 for the same period in 2024, reflecting a 49.5% increase [29] - Net income for Q3 2025 was $10,325,000, a substantial recovery from a net loss of $20,657,000 in Q3 2024 [29] - Net income for the nine months ended September 30, 2025, was $5,704, compared to a net loss of $18,624 in the same period of 2024 [32] - The company reported a basic earnings per share of $1.20 for Q3 2025, compared to a loss of $6.49 per share in Q3 2024 [29] Sales and Revenue Growth - The company sold 155 UltraMist® systems in Q3 2025, an all-time quarterly record, compared to 124 in Q3 2024 [7][8] - UltraMist® consumables revenue increased by 26% to $6.8 million in Q3 2025, up from $5.4 million in Q3 2024 [7] - The company provides guidance for Q4 2025 revenues of $13-$14 million, representing a 35-39% increase compared to full year 2024 [5][9] - Full year revenue guidance is set at $44-$45 million, reflecting significant growth compared to the previous year [9] - Total revenue for Q3 2025 was $11,451,000, representing a 22.2% increase from $9,360,000 in Q3 2024 [29] Financial Position and Assets - Total assets increased to $35,599,000 as of September 30, 2025, compared to $30,119,000 at the end of 2024, marking an 18.1% growth [25] - Current liabilities decreased to $19,577,000 from $42,345,000, showing a reduction of 53.8% [25] - Total stockholders' deficit improved to $(2,931,000) from $(12,717,000) at the end of 2024, indicating a positive shift in financial health [28] - Cash and cash equivalents were $9,602,000 as of September 30, 2025, down from $10,237,000 at the end of 2024 [25] Expenses and Cash Flow - Research and development expenses increased to $345,000 in Q3 2025 from $161,000 in Q3 2024, reflecting a focus on innovation [29] - Cash flows provided by operating activities decreased to $557, down from $1,714 in the prior year [32] - Cash paid for interest was $3,291, slightly up from $3,189 in the previous year [34] - The company capitalized interest into senior secured debt amounting to $549, compared to $3,850 in the prior year [34] - The net cash flows used in financing activities were $4,346, compared to $119 in the previous year, indicating increased financing outflows [33] Gains and Losses - The company reported a gain on the sale of patents amounting to $5,000, with no comparable figure in 2024 [32] - The change in fair value of derivative liabilities resulted in a loss of $2,186, contrasting with a gain of $17,633 in the prior year [32] - The company reported a loss on extinguishment of debt of $477, compared to a gain of $5,205 in the previous year [32] Future Outlook - The company anticipates a robust sales pipeline and increased inbound interest from customers following the recent CMS reimbursement rule [8]

Core Insights - Sanuwave Health, Inc. reported record revenues of $11.5 million for Q3 2025, marking a 22% increase from $9.4 million in Q3 2024, the highest quarterly revenues in the company's history [1][6][5] - The gross margin for Q3 2025 was 77.9%, up from 75.5% in Q3 2024 [1][6] - The company anticipates Q4 2025 revenues between $13 million and $14 million, projecting full-year revenues of $44 million to $45 million, representing a 35-39% increase compared to the full year 2024 [2][7] Financial Performance - Q3 2025 operating income was $1.5 million, down from $2.0 million in Q3 2024, with stock-based compensation costs of $1.4 million included in Q3 2025 [2][6] - Net income for Q3 2025 was $10.3 million, a significant recovery from a net loss of $20.7 million in Q3 2024, primarily due to a non-cash gain of $6.1 million from the change in fair value of derivative liabilities [6][25] - Adjusted EBITDA for Q3 2025 was $3.5 million, compared to $2.1 million for the same period last year [6][25] Sales and Market Dynamics - The company sold 155 UltraMist® systems in Q3 2025, an all-time quarterly record, compared to 124 in Q3 2024 [5][6] - UltraMist® consumables revenue increased by 26% to $6.8 million in Q3 2025, representing 99% of Sanuwave's overall revenues [6][5] - Despite industry headwinds related to proposed reimbursement changes, Sanuwave's sales pipeline remains robust, with increased inbound interest from customers and distribution partners [5][6] Industry Context - The CEO noted that the industry experienced a cautious approach due to uncertainty regarding reimbursement changes, but the final rule for 2026 Medicare physician fees provided some clarity, which is expected to positively influence market adaptation [5][6] - The company is focused on the research, development, and commercialization of non-invasive medical systems for wound care and regenerative medicine [9][10]

Financial Performance - Revenue for Q3 2025 was $11,451,000, representing a 22.1% increase from $9,360,000 in Q3 2024[15] - Gross margin improved to $8,925,000 in Q3 2025, up from $7,067,000 in Q3 2024, indicating a stronger profitability[15] - Operating income for the nine months ended September 30, 2025, was $4,330,000, compared to $2,895,000 for the same period in 2024, reflecting a 49.5% increase[15] - Net income for Q3 2025 was $10,325,000, a significant recovery from a net loss of $20,657,000 in Q3 2024[15] - For the nine months ended September 30, 2025, the company reported a net income of $5,704,000 compared to a net loss of $18,624,000 in the same period of 2024, indicating a significant turnaround[23] - Total revenue for the three months ended September 30, 2025, was $11.451 million, representing a 22.9% increase from $9.360 million in the same period of 2024[85] - Revenue for the three months ended September 30, 2025, was $11.5 million, a 22% increase compared to $9.4 million in the same period of 2024[114] - For the nine months ended September 30, 2025, revenue totaled $31.0 million, a 39% increase from $22.3 million in the same period of 2024[114] - Operating income for the nine months ended September 30, 2025, was $4.3 million, an improvement of $1.4 million compared to the same period in 2024[116] - The company had a gross margin of $8.9 million for the three months ended September 30, 2025, compared to $7.1 million for the same period in 2024[112] - General and administrative expenses for the three months ended September 30, 2025, were $4.8 million, compared to $2.5 million in the same period of 2024[112] Assets and Liabilities - Total current assets increased to $22,633,000 as of September 30, 2025, compared to $18,397,000 at the end of 2024, marking a 22.3% growth[13] - Total liabilities decreased to $38,530,000 as of September 30, 2025, down from $42,836,000 at the end of 2024, indicating improved financial health[13] - Cash and cash equivalents were $9,602,000 as of September 30, 2025, slightly down from $10,237,000 at the end of 2024[13] - The company reported a total stockholders' deficit of $2,931,000 as of September 30, 2025, an improvement from a deficit of $12,717,000 at the end of 2024[14] - Cash at the end of the period was $9,602,000, up from $3,259,000 at the end of the same period in 2024[25] - The allowance for credit losses increased to $1,259,000 as of September 30, 2025, from $1,056,000 a year earlier, with a provision for credit losses of $153,000 compared to $67,000 in the prior year[54] Cash Flow and Financing Activities - Operating cash flows provided by operating activities were $557,000, a decrease from $1,714,000 in the prior year[23] - The company reported a net cash flow used in financing activities of $4,346,000, compared to $119,000 in the prior year[23] - Cash flows from operating activities for the nine months ended September 30, 2025, were impacted by non-cash charges totaling $3.5 million related to stock-based compensation[141] - Cash provided by investing activities for the same period was $3.2 million, primarily from a patent purchase agreement of $5 million[143] - Cash used in financing activities for the nine months ended September 30, 2025, totaled $4.3 million, mainly for paying off existing debt[145] Debt and Equity - The company executed a comprehensive debt refinancing, extending the maturity of principal debt obligations and providing additional liquidity through a secured revolving credit facility[34] - The Company entered into a new secured term loan of $23 million and a $5 million revolving credit facility, with interest rates based on SOFR plus a margin of 3.50% or CBFR plus a margin of 2.50%[63] - The company recognized a gain on the sale of patents amounting to $5,000,000 during the nine months ended September 30, 2025[23] - The company incurred stock-based compensation expenses of $3,513,000 for the nine months ended September 30, 2025, compared to no such expenses in the prior year[23] - The company recognized a $5.0 million gain on the sale of patents within Other Income for the three and nine months ended September 30, 2025[105] Operational Highlights - Research and development expenses increased to $747,000 for the nine months ended September 30, 2025, compared to $519,000 for the same period in 2024, reflecting a focus on innovation[15] - The quantity of UltraMIST systems sold increased by 54% in the nine months ended September 30, 2025, compared to the same period of 2024[124] - Consumables and parts revenue for the nine months ended September 30, 2025, was $19.806 million, up 33.3% from $14.879 million in the prior year[85] - Revenue for the nine months ended September 30, 2025, was $31.0 million, a 39% increase from $22.3 million in the same period of 2024, driven by a 28% increase in UltraMIST disposables sold[124] Corporate Governance and Compliance - The company is committed to addressing material weaknesses in internal controls and has engaged CliftonLarsonAllen LLP for valuation assistance[157] - The company plans to enhance internal controls and has hired a Director of Internal Audit to oversee these efforts[158] - The company has filed various certificates of amendment to its Articles of Incorporation, with the most recent effective as of October 18, 2024[171] - The ongoing amendments and agreements suggest a proactive approach to corporate governance and strategic partnerships within the healthcare sector[170] - The company has incorporated XBRL (eXtensible Business Reporting Language) for its financial reporting, enhancing transparency and accessibility of financial data[171]

Core Viewpoint - Sanuwave Health, Inc. will present its Q3 2025 financial results in a live conference call on November 7, 2025, at 8:30 AM (ET) [1] Company Overview - Sanuwave Health is a provider of next-generation FDA-approved wound care products, focusing on the research, development, and commercialization of patented, non-invasive medical systems for skin, musculoskeletal tissue, and vascular structure repair and regeneration [2][3] Product Portfolio - The company offers an end-to-end wound care portfolio of regenerative medicine products that aim to restore the body's normal healing processes, utilizing patented energy transfer technologies across various medical conditions including wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular [3]

Core Insights - The final rule for the 2026 Physician Fee Schedule by CMS aligns with the proposed rule and shows minimal changes from 2025 rates [1][2][3] - Reimbursement for the CPT code 97610 related to UltraMIST products remains largely unchanged, with payment rates for various treatment settings staying within $2-4 of 2025 levels [2][3] Summary by Sections Reimbursement Rates - The reimbursement for the 97610 code for UltraMIST products is expected to remain materially unchanged for 2026, with rates for physician offices, home visits, long-term care, and hospitals staying within $2-4 of 2025 rates [2] - Changes for 2026 are anticipated to be less than 1%, with many providers likely to see a slight increase in reimbursement [3] Company Response - In response to inquiries regarding UltraMIST reimbursement rates, the company provided an update confirming that the final 2026 rates are consistent with prior expectations [3] - The company plans to discuss these developments further during its third quarter earnings call [3]

Core Insights - SRK Fund I, LP achieved a return of 46.94% in the first half of 2025, significantly outperforming the S&P 500 and Russell 2000, which returned 6.20% and -1.78% respectively [2][3] - Since its inception on May 1, 2018, the fund has appreciated 1200.66%, compared to 162.30% for the S&P 500 and 55.46% for the Russell 2000 [2][3] - The fund manager emphasizes the importance of long-term performance evaluation rather than short-term results [4] Portfolio Updates - **Innovative Solutions & Support (ISSC)**: Contributed significantly to the fund's performance with a 104% revenue increase and Ebitda margins reaching 35%. The company is expanding through strategic acquisitions and has increased its manufacturing capacity [6][7] - **ImmuCell Corporation (ICCC)**: Reported record first-quarter results with gross margins expanding to 42%. The company is targeting further growth and has received investigational use authorization for its product Re-Tain, which is pending FDA approval [8][9][10] - **Soléance (SLSN)**: Experienced a 53% revenue growth in the first half of the year despite lower margins due to onboarding costs. The company resolved litigation issues and uplisted to Nasdaq, which positively impacted its stock price [11] - **Sanuwave Health, Inc. (SNWV)**: Achieved 51% revenue growth without a national sales presence. The company has now established a national sales force and is pursuing debt refinancing options [12][13] Closing Thoughts - The strong returns in the first half of the year are viewed as a recovery from the previous year's poor performance. The fund has increased its cash reserves to capitalize on future investment opportunities [14]

Core Insights - Sanuwave Health Inc. (SNWV) shares experienced a significant increase of 9.1%, closing at $40.82, following a trading session with higher-than-average volume [1] - The rise in shares is linked to the company reporting record preliminary Q3 2025 revenues between $11.4 million and $11.6 million, indicating a year-over-year increase of 22% to 24% and a sequential increase of 12% to 14% [2] - The company is projected to report quarterly earnings of $0.37 per share, reflecting a year-over-year growth of 105.7%, with expected revenues of $12.37 million, up 32.2% from the previous year [3] Revenue and Earnings Estimates - The consensus EPS estimate for Sanuwave Health has been revised 35.7% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - September marked the highest revenue month in Sanuwave's history, contributing to positive investor sentiment and indicating sustained demand [2] Industry Context - Sanuwave Health is categorized under the Zacks Medical - Products industry, where InMode (INMD) is another player, having closed 0.5% higher at $15.23 [5] - InMode's consensus EPS estimate has remained unchanged at $0.32, representing a decline of 54.3% from the previous year, and it currently holds a Zacks Rank of 3 (Hold) [6]