Financial Performance - Sanara MedTech Inc. reported a quarterly loss of $0.41 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.31, and compared to a loss of $0.21 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $23.43 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 5.32%, and showing an increase from year-ago revenues of $18.54 million [2] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $25.35 million, and for the current fiscal year, it is -$1.78 on revenues of $107.2 million [7] - The estimate revisions trend for Sanara MedTech is mixed, leading to a Zacks Rank 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Market Performance - Sanara MedTech shares have increased by approximately 5.7% since the beginning of the year, outperforming the S&P 500, which gained only 0.1% [3] - The outlook for the industry, specifically the Medical - Products sector, is currently in the bottom 31% of over 250 Zacks industries, which may impact the stock's performance [8]

Financial Data and Key Metrics Changes - Sonera Surgical segment delivered net revenue of $23.4 million, representing a 26% year-over-year growth, driven primarily by a 28% increase in sales of soft tissue repair products to $20.5 million [5][6] - Gross profit increased by $5 million or 30% to $21.6 million, with gross margin rising approximately 240 basis points to 92% of net revenue [21][22] - Net loss for the first quarter was $3.5 million or $0.41 per diluted share, compared to a net loss of $1.8 million or $0.21 per diluted share last year [23][24] - Adjusted EBITDA for the first quarter was $700,000, an increase of 111% year-over-year [24] Business Line Data and Key Metrics Changes - In the Tissue Health Plus segment, the company continues to invest in developing a value-based wound care strategy, preparing to launch a pilot program with a wound care provider later in the second quarter [6][20] - The Synera Surgical segment generated operating income of $800,000 in the first quarter, an increase of $1 million year-over-year [22][24] - Tissue Health Plus segment generated a net loss of $2.9 million compared to a net loss of $1.4 million last year [24] Market Data and Key Metrics Changes - The company expanded its distributor network to over 400 partners, up from over 250 in the first quarter of 2024, enhancing sales coverage in key markets across the US [10][11] - Products were sold in over 1,300 healthcare facilities, compared to over 1,080 facilities in the prior year period [11][12] Company Strategy and Development Direction - The company is focused on three commercial initiatives: advancing distributor relationships, selling into new healthcare facilities, and increasing penetration in existing facilities [10][12] - The company aims to onboard and train additional distributor representatives to increase sales within existing distributor relationships [14][15] - The company is also pursuing financial partners to invest in the execution of its Tissue Health Plus strategy [7][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong start to 2025 and remains focused on delivering net revenue growth, particularly in the Synera Surgical segment [26] - The company does not anticipate a material impact from tariffs on its operations in 2025, as most products are manufactured in the US [27] Other Important Information - The company amended the terms of its debt facility to provide increased financial flexibility [8] - The THP CoPilot software platform was released, designed to standardize wound care and reduce administrative burdens for clinicians [17][18] Q&A Session Summary Question: Can you provide more insight into penetration rates and strategies for improvement? - Management indicated a coupled approach between territory managers and distributor expansion to penetrate existing accounts deeper [30][31] Question: Are there any reorder rates available for the products? - Management noted that while specific reorder rates are not disclosed, once surgeons gain comfort with the products, they tend to continue using them for more procedures [32] Question: How should gross margin be viewed for the remainder of 2025? - Management suggested that while there may not be significant additional leverage on gross margin, consistency in modeling is advisable [36][37] Question: What metrics will define success for the initial pilot program in Tissue Health Plus? - Success will be measured through clinician adherence to protocols, reduction in post-encounter time, staff productivity, and user satisfaction metrics [41][44]

Financial Data and Key Metrics Changes - The company reported net revenue of $23.4 million for Q1 2025, representing a 26% year-over-year growth, driven primarily by a 28% increase in sales of soft tissue repair products to $20.5 million [5][6] - Gross profit increased by $5 million or 30% to $21.6 million, with gross margin rising approximately 240 basis points to 92% of net revenue [22] - The net loss for Q1 2025 was $3.5 million or $0.41 per diluted share, compared to a net loss of $1.8 million or $0.21 per diluted share in the previous year [24] Business Line Data and Key Metrics Changes - In the Synera Surgical segment, adjusted EBITDA increased by $1.5 million year-over-year to $2.7 million, while the net loss increased by $200,000 to $600,000 [6][24] - The Tissue Health Plus segment reported a net loss of $2.9 million, up from a net loss of $1.4 million in the previous year, with a segment adjusted EBITDA loss of $2 million compared to a loss of $900,000 last year [24] Market Data and Key Metrics Changes - The company expanded its distributor network to over 400 partners, up from over 250 in Q1 2024, enhancing sales coverage in key markets across the U.S. [10] - The number of healthcare facilities served increased to over 1,300, compared to over 1,080 facilities in the prior year [11] Company Strategy and Development Direction - The company is focused on enhancing its new product pipeline and has secured distribution rights to two additional technologies [7] - The strategy includes investing in the Tissue Health Plus segment and launching a pilot program with a wound care provider later in Q2 2025 [6][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth opportunities ahead, particularly in the Synera Surgical segment, and expects improvements in profitability for 2025 [27] - The company is actively seeking financial partners to support the execution of its Tissue Health Plus strategy [27] Other Important Information - The company amended the terms of its debt facility to provide increased financial flexibility [7] - As of March 31, 2025, the company had $20.7 million in cash and $42.8 million in principal debt obligations outstanding [25] Q&A Session Summary Question: Can you provide more details on your penetration rates and strategy for improving penetration at existing facilities? - The company employs a coupled approach between regional sales managers and distributor expansion to penetrate existing accounts deeper [31] Question: Are there any signals on reorder rates for your products? - The company has not provided specific reorder rates but noted that once surgeons gain comfort with their products, they tend to continue using them across more procedures [33] Question: How should we think about gross margin cadence through the remainder of 2025? - Management indicated that while there may not be significant further leverage on gross margins, consistency with past modeling is advisable [38] Question: What metrics will define success for the pilot program in Tissue Health Plus? - Success will be measured through clinician-facing metrics, operational metrics, and adoption metrics, including protocol adherence and clinician satisfaction [41][45]

Financial Performance - Net revenue for Q1 2025 increased by 26% year-over-year to $23.4 million, up from $18.5 million in Q1 2024[5] - Gross profit for Q1 2025 was $21.6 million, a 30% increase from $16.6 million in Q1 2024, with a gross margin of 92%[9] - Net revenue for the three months ended March 31, 2025, was $23,434,096, representing a 26.5% increase from $18,536,638 in the same period of 2024[24] - Gross profit for the same period was $21,599,129, up from $16,646,592, indicating a gross margin improvement[24] - Segment Adjusted EBITDA for the total was $657,969 for Q1 2025, compared to $311,421 in Q1 2024, reflecting an increase of approximately 111%[32] - Segment Adjusted EBITDA as a percentage of Net Revenue for Q1 2025 was 2.8%, up from 1.7% in Q1 2024, showing improved operational efficiency[32] Expenses and Losses - Operating expenses increased by 30% to $23.7 million, driven by a 32% rise in selling, general and administrative expenses[10] - Net loss for Q1 2025 was $3.5 million, compared to a net loss of $1.8 million in Q1 2024[13] - Operating loss increased to $2,080,029 for Q1 2025 compared to a loss of $1,531,707 in Q1 2024[24] - Net loss attributable to Sanara MedTech shareholders was $3,527,177 for Q1 2025, compared to $1,764,184 in Q1 2024, reflecting a significant increase in losses[24] - The net loss for the three months ended March 31, 2025, was $(3,527,383), compared to $(1,799,043) in the prior year, indicating a significant increase in losses[32] - Net Loss as a percentage of Net Revenue for Q1 2025 was (15.1)%, compared to (9.7)% in Q1 2024, indicating a worsening loss margin[32] Cash and Debt Management - As of March 31, 2025, the company had $20.7 million in cash and $42.8 million in principal debt obligations[15] - Total current assets rose to $36,842,548 as of March 31, 2025, compared to $33,305,988 at the end of 2024, driven by an increase in cash and inventory[22] - Long-term debt increased to $43,402,223 as of March 31, 2025, up from $30,689,290 at the end of 2024, indicating higher leverage[22] - Cash at the end of the period was $20,687,806, a significant increase from $15,878,295 at the end of 2024, reflecting improved cash flow management[26] - Total liabilities increased to $59,711,004 as of March 31, 2025, compared to $49,180,030 at the end of 2024, indicating a rise in financial obligations[22] Product Sales and Initiatives - Sales of soft tissue repair products rose by 28% to $20.5 million, while bone fusion products increased by 18% to $2.9 million[8] - Sanara plans to launch its first pilot program for the Tissue Health Plus initiative in Q2 2025 and is seeking financial partners for this strategy[6] - The company aims to address the large surgical greenfield opportunity and improve profitability in its Sanara Surgical segment throughout 2025[6] Research and Development - Research and development expenses for Q1 2025 were $1,114,138, compared to $946,298 in Q1 2024, highlighting continued investment in innovation[24] Other Financial Metrics - Adjusted EBITDA for Q1 2025 was $0.7 million, up from $0.3 million in Q1 2024, with the Sanara Surgical segment contributing $2.7 million[14] - Interest expense for Q1 2025 was $1,317,092, compared to $267,336 in Q1 2024, highlighting a significant increase in financing costs[32] - Noncash share-based compensation for Q1 2025 totaled $1,304,904, compared to $803,386 in Q1 2024, indicating an increase of approximately 62%[32] - Acquisition costs for Q1 2025 amounted to $308,684, reflecting ongoing investment in growth strategies[32] - Depreciation and amortization expenses for Q1 2025 were $1,124,410, compared to $1,105,420 in Q1 2024, showing a slight increase[32] - The share of losses from equity method investments was $143,608 for Q1 2025, with no losses reported in Q1 2024, indicating new challenges in equity investments[32]

Core Insights - Sanara MedTech Inc. reported a 26% year-over-year increase in net revenue for Q1 2025, reaching $23.4 million compared to $18.5 million in Q1 2024 [6][10][15] - The company experienced a net loss of $3.5 million in Q1 2025, which is an increase from a net loss of $1.8 million in the same period last year [15][27] - Adjusted EBITDA improved to $0.7 million in Q1 2025, up from $0.3 million in Q1 2024, indicating better operational performance [16][32] Financial Performance - Net revenue increased by $4.9 million, driven by a $4.5 million (28%) rise in soft tissue repair products and a $0.4 million (18%) increase in bone fusion products [10][11] - Gross profit for Q1 2025 was $21.6 million, a 30% increase from $16.6 million in Q1 2024, with a gross margin of 92% compared to 90% in the previous year [11][12] - Operating expenses rose to $23.7 million, a 30% increase from $18.2 million in Q1 2024, primarily due to higher selling, general, and administrative expenses [12][13] Operational Developments - The company executed an exclusive license and distribution agreement with Biomimetic Innovations Ltd, acquiring U.S. marketing rights for a new bone void filler product [7][8] - Sanara expanded its executive leadership team with new appointments, including a new Chief Financial Officer [7][8] - The company is preparing to launch a pilot program for its Tissue Health Plus initiative in collaboration with a wound care provider group [8] Cash and Debt Position - As of March 31, 2025, Sanara had $20.7 million in cash and $42.8 million in principal debt obligations, with an additional borrowing capacity of $12.25 million [17][24] - The company borrowed $12.25 million under its term loan agreement, which may be used for acquisitions and working capital [7][17] Market Focus - Sanara MedTech is focused on developing transformative technologies in the surgical, chronic wound, and skincare markets, aiming to improve clinical outcomes and reduce healthcare costs [20][21] - The company markets a range of products in the advanced wound care and surgical tissue repair markets, with a strong emphasis on expanding its distribution network [20][21]

Core Viewpoint - Sanara MedTech Inc. is set to report its first quarter 2025 financial results on May 14, 2025, before U.S. markets open, indicating ongoing developments in its financial performance and business strategy [1]. Group 1: Financial Reporting - The company will host a conference call and webcast on May 14, 2025, at 8:00 a.m. Eastern Time to discuss the financial results for the quarter ended March 31, 2025, followed by a Q&A session [2]. - A telephonic replay of the conference call will be available until May 28, 2025, providing access to the discussion for those unable to attend live [2]. Group 2: Company Overview - Sanara MedTech Inc. focuses on developing and commercializing transformative technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical, chronic wound, and skincare markets [4]. - The company markets and distributes a range of surgical, wound, and skincare products primarily in the North American advanced wound care and surgical tissue repair markets [4]. - Key products include CellerateRX Surgical Activated Collagen, FORTIFY TRG Tissue Repair Graft, and various advanced biologic products, indicating a diverse product portfolio [4]. - The company is actively seeking long-term strategic partnerships to enhance product offerings that improve outcomes at a lower overall cost [4].

Core Viewpoint - Sanara MedTech Inc. is set to present at the Planet MicroCap Showcase: VEGAS 2025, highlighting its focus on developing transformative medical technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical, chronic wound, and skincare markets [1] Company Overview - Sanara MedTech Inc. specializes in medical technology, focusing on the development and commercialization of innovative products to enhance clinical outcomes and lower healthcare expenditures [3] - The company markets and distributes a range of surgical, wound, and skincare products primarily in the North American advanced wound care and surgical tissue repair markets [3] - Key products include CellerateRX® Surgical Activated Collagen®, FORTIFY TRG® Tissue Repair Graft, and various advanced biologic products such as ACTIGEN® Verified Inductive Bone Matrix and BIASURGE® Advanced Surgical Solution [3] - Sanara also offers telemedicine services for wound care and dermatology consultations, aiming to improve patient outcomes while managing costs [3] Upcoming Presentation - Management will present to investors on April 23, 2025, at approximately 3:30 p.m. Pacific Time during the Planet MicroCap Showcase [1] - Presentation materials will be available on the company's investor relations website prior to the event, along with a live audio webcast and an archive for later access [2]

Company Overview - Sanara MedTech Inc. (SMTI) shares increased by 8.1% to $29.20 in the last trading session, following a significant volume of trading, contrasting with a 15.5% loss over the past four weeks [1] - The recent stock price increase is attributed to a relief rally in global markets due to a 90-day pause on tariff hikes announced by the United States [1] Earnings Expectations - Sanara MedTech is projected to report a quarterly loss of $0.31 per share, reflecting a year-over-year decline of 47.6% [2] - Expected revenues for the upcoming quarter are $22.25 million, which represents a 20% increase compared to the same quarter last year [2] Earnings Estimate Revisions - The consensus EPS estimate for Sanara MedTech has been revised down by 16% over the last 30 days [3] - A negative trend in earnings estimate revisions typically does not lead to price appreciation, indicating potential caution for future stock performance [3] Industry Context - Sanara MedTech operates within the Zacks Medical - Products industry, where another company, Perrigo (PRGO), saw its shares rise by 5.4% to $25.87, despite a -11.9% return over the past month [3] - Perrigo's consensus EPS estimate has decreased by 9.2% over the past month to $0.53, which is an increase of 82.8% compared to the previous year [4]

Business Segments and Strategy - The company operates through two reportable segments: Sanara Surgical and Tissue Health Plus (THP) to enhance resource allocation and management focus [20]. - Sanara Surgical segment includes products like CellerateRX Surgical and BIASURGE, with CellerateRX Surgical primarily used for surgical wound management and BIASURGE launched in November 2023 [21][28]. - THP aims to introduce a value-based wound care program targeting Medicare Advantage payers, expected to launch a pilot program in Q2 2025 [24][33]. - THP's contracts are anticipated to have three-to-five-year terms, incorporating value-based pricing methodologies to align with payer financial goals [34]. - The company established a joint venture, SI Healthcare Technologies, with InfuSystem to enhance wound care solutions and improve patient outcomes [37]. - The company seeks partnerships and acquisitions to enhance its product and service offerings, particularly in value-based care models [41][42]. - The company plans to expand its geographic footprint and deepen market penetration in the surgical, wound, and skincare markets [39]. - New innovative products are under development to improve surgical site outcomes and treat chronic wounds, focusing on efficacy and cost-effectiveness [40]. Market Opportunities - Approximately 15% of the Medicare beneficiary population has chronic nonhealing wounds, indicating a significant market opportunity for the company's products [49]. - Over 34 million people in the U.S., or about 10% of the population, suffer from diabetes, which is associated with poor wound healing and presents a substantial market for diabetic foot ulcer treatments [50]. - Venous leg ulcers affect approximately 600,000 people annually in the U.S., highlighting another critical area for the company's wound care solutions [51]. - The surgical and wound care markets are expected to grow due to demographic trends and increasing healthcare costs, with the company positioned to benefit from this growth [44]. Product Development and Innovation - The company has a robust pipeline of surgical, wound, and skincare products expected to be marketed soon, with a focus on statistically significant clinical and health economic outcomes data to drive adoption and lower costs for payors [47]. - The company has demonstrated a 59% reduction in surgical site infection rates when using CellerateRX Surgical collagen in elective multispecialty surgical procedures, with a 69% decrease in clean cases [55]. - The company has a pipeline of product candidates aimed at addressing opportunistic pathogens and wound healing, but successful commercialization is uncertain [127]. - Future success relies on the ability to educate healthcare practitioners on the benefits and proper use of the company's products, which is critical for market acceptance [129]. Regulatory Environment - Medical devices must obtain FDA marketing clearance through the 510(k) premarket notification process, de novo classification, or PMA process, unless exempt [71]. - Class II devices generally require a 510(k) premarket notification, while most Class I devices are exempt from this requirement [72]. - The FDA must classify a de novo classification request within 120 days, and manufacturers must propose special controls for Class II devices [73]. - Class III devices require PMA approval, which involves extensive data demonstrating safety and effectiveness, and the FDA has 180 days to review the application [74]. - Clinical trials are often required for PMAs and sometimes for 510(k) submissions, with significant risk devices needing an IDE application [75]. - The company is subject to various governmental regulations that could impact the commercialization of new products, including delays in FDA approvals [116]. - The company faces significant challenges in complying with FDA regulations and maintaining good manufacturing practices, which could jeopardize product commercialization [124]. - Regulatory compliance is costly and time-consuming, impacting the development and marketing of products [146]. Financial Performance and Risks - The company has incurred net losses in most years since 2004 and plans to continue significant investments in its THP operating segment, which will substantially increase operating expenses [102]. - The company faces challenges in predicting revenue growth, and a shortfall in forecasted revenues may harm operating results [99]. - The company has experienced fluctuations in revenue and operating results, making future revenue growth difficult to predict [104]. - The company’s indebtedness could adversely affect its financial condition and limit its ability to fund operations and growth [117]. - The company anticipates that economic conditions and changes in reimbursement rates could impact its ability to sell products [108]. - The company expects pricing pressures due to increasing efforts by payors to limit healthcare costs, which may affect profitability [166]. Compliance and Legal Issues - The company is subject to extensive healthcare fraud and abuse laws, and noncompliance could result in substantial penalties [169]. - The company must comply with HIPAA regulations, which impose strict privacy and security standards for protected health information [90]. - The company may face civil and criminal penalties for violations of HIPAA, with significant repercussions for breaches affecting more than 500 individuals [91]. - The company faces risks from potential litigation related to intellectual property rights, which could divert resources and impact operations [145]. Corporate Governance and Shareholder Matters - The company has provisions in its Certificate of Formation that may limit shareholder actions against directors for breaches of fiduciary duties [198]. - The company has anti-takeover provisions that could delay or discourage favorable takeover attempts [199]. - A significant percentage of voting stock is controlled by a few shareholders, which may lead to conflicts of interest and affect corporate governance [195]. - The company has not paid cash dividends and does not plan to in the near future, limiting returns for shareholders [194]. Cybersecurity and Technology - The company has invested in cybersecurity measures, including growing its internal technology team and obtaining cybersecurity insurance [207]. - The company has not experienced any material adverse effects from cybersecurity threats to date [209].

Financial Performance and Key Metrics - The company generated net revenue of $86.7 million for the full-year 2024, representing growth of 33% year-over-year [7] - Adjusted EBITDA for 2024 was $2.7 million, an increase of $2.6 million compared to 2023 [8] - As of December 31, 2024, the company had $15.9 million in cash and $24.5 million available for future borrowings [9] Business Segment Performance - In the Sanara Surgical segment, net revenue increased by 39% year-over-year to $76.1 million, while bone fusion products saw a 6% increase to $10.5 million [7] - The Tissue Health Plus segment continued to incur losses as investments were made in preparation for commercialization [8][9] - Fourth quarter net revenue for the Sanara Surgical segment was $23.5 million, a 56% increase year-over-year [15] Market Data and Key Metrics - The company expanded its distributor network to over 350 partners by year-end 2024, up from more than 250 in 2023 [18] - Products were sold in over 1,300 facilities by year-end 2024, an increase from over 1,000 in 2023 [21] Company Strategy and Industry Competition - The company is focused on empowering physicians to improve patient outcomes while reducing healthcare costs, aiming for long-term growth and shareholder value [12] - A strategic partnership with Biomimetic Innovations was announced, which includes exclusive rights to market innovative products in the U.S. [29] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to enhance sales coverage and market penetration in 2025 [12] - The company plans to launch its first pilot program in the Tissue Health Plus segment during the second quarter of 2025 [27] Other Important Information - The company submitted 11 provisional patent applications in 2024, covering innovations in antimicrobial technologies and hydrolyzed collagen [11] - The company amended the terms of its CRG term loan to provide more flexibility for future borrowings [44] Q&A Session Summary Question: What is the game plan for ChemoMouthpiece in 2025? - Management indicated that the ChemoMouthpiece is being introduced to the market, with health economics and clinical study results expected soon [50][51] Question: How will success be measured for the THP pilot launch? - Success will be measured by the integration with the pilot customer's systems and the standardization of clinical workflows [56] Question: What business development efforts are in place beyond the initial pilot? - Significant efforts have been made in commercial development, including creating a value-based pricing model and recruiting a sales team [66]