Sanara MedTech(SMTI)

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Sanara MedTech(SMTI) - 2023 Q3 - Quarterly Report
2023-11-13 21:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 001-39678 SANARA MEDTECH INC. (Exact name of Registrant as specified in its charter) Texas 59-2219994 (State or other jurisdict ...
Sanara MedTech(SMTI) - 2023 Q2 - Earnings Call Transcript
2023-08-15 17:51
Sanara Medtech, Inc. (NASDAQ:SMTI) Q2 2023 Earnings Conference Call August 15, 2023 9:00 AM ET Company Participants Callon Nichols - VP, Corporate Operations Ron Nixon - Executive Chairman Zach Fleming - CEO Mike McNeil - CFO Conference Call Participants Ross Osborn - Cantor Fitzgerald Ian Cassel - MicroCap Club Operator Greetings. Welcome to the Sanara MedTech Inc. Second Quarter 2023 Results and Business Update Conference Call. [Operator Instructions]. Please note that this conference is being recorded. I ...
Sanara MedTech(SMTI) - 2023 Q2 - Quarterly Report
2023-08-14 20:02
☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 001-39678 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q SANARA MEDTECH INC. (Exact name of Registrant as specified in its charter) Texas 59-2219994 (State or other jurisdiction o ...
Sanara MedTech(SMTI) - 2023 Q1 - Earnings Call Transcript
2023-05-16 17:46
Sanara MedTech Inc. (NASDAQ:SMTI) Q1 2023 Earnings Conference Call May 16, 2023 9:00 AM ET Company Participants Callon Nichols - Director, Investor Relations Ron Nixon - Chairman Zach Fleming - Chief Executive Officer Mike McNeil - Chief Financial Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Ian Cassel - IFCM Operator Good morning. And welcome to the Sanara MedTech Inc. First Quarter 2023 Results and Business Update Conference Call. [Operator Instructions] I’d now like to turn the ca ...
Sanara MedTech(SMTI) - 2023 Q1 - Quarterly Report
2023-05-15 20:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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 001-39678 SANARA MEDTECH INC. (Exact name of Registrant as specified in its charter) | Texas | 59-2219994 | | --- | --- | | (State ...
Sanara MedTech(SMTI) - 2022 Q4 - Earnings Call Transcript
2023-03-21 16:43
Financial Data and Key Metrics Changes - The company generated $45.8 million in net revenue for 2022, representing a 90% increase from $24.1 million in 2021 [58][89] - The net loss for 2022 was $8.1 million, slightly higher than the $8 million loss in 2021, impacted by increased SG&A costs and R&D expenses [21][64][90] Business Line Data and Key Metrics Changes - Cellerate sales continued to show strong growth, contributing significantly to the revenue increase [18][66] - Sales at Scendia remained flat from Q3 to Q4 due to supply issues with the Allocyte product [21][82] Market Data and Key Metrics Changes - CellerateRX was sold in 700 hospitals and ASCs across 29 states, with approval to be sold in over 1700 facilities [2] - The company is focusing on existing accounts rather than new facility approvals to maximize product introduction [3] Company Strategy and Development Direction - The company aims to raise capital for acquisitions and partnerships, enhance liquidity, and fund product development and clinical studies [1] - A strategic focus on comprehensive wound care solutions is being pursued, with partnerships being sought to enhance offerings [5][7] Management's Comments on Operating Environment and Future Outlook - Management expects improvements in supply issues for the Allocyte product in the second half of 2023 [4][19] - The company believes it will be the first to market with its comprehensive wound care strategy, which is anticipated to be well received [30][67] Other Important Information - The company dissolved Sanara Pulsar in December 2022 due to minimal sales and lack of reimbursement code [22][63] - R&D expenses increased significantly to $3.4 million in 2022, primarily due to costs related to the Precision Healing diagnostic imager [62] Q&A Session Summary Question: Can you provide insights on cross-selling abilities in Q4? - Management noted that cross-selling is going well, with products being complementary and gaining traction [70] Question: What is the commercialization plan for Precision? - The company anticipates a lease program for marketing Precision and highlighted its differentiation from the predicate device [72][73] Question: How does the company view private market valuations for acquisitions? - Management indicated that valuations do not significantly impact their acquisition strategy, focusing instead on alignment of interests [76][78] Question: What are the challenges to continuing growth for Cellerate? - Challenges include ensuring field presence and establishing a research base to support product efficacy [26] Question: What is the status of clinical studies with Cellerate? - The company has several studies underway, with positive results expected to be published soon [125][126]
Sanara MedTech(SMTI) - 2022 Q4 - Annual Report
2023-03-20 20:02
Medical Technology Development - The company focuses on developing transformative medical technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical, chronic wound, and skincare markets [20]. - The company has a robust pipeline of products under development, including next-generation CellerateRX Surgical and a sterile antimicrobial wound solution [37]. - The company is actively developing proprietary products and technologies, with a focus on patent protection to safeguard innovations in the surgical and chronic wound markets [69]. - The company is developing an autolytic debrider product and a sterile antimicrobial surgical wash product, with discussions ongoing regarding the best path for seeking clearance and approval [105]. - The company plans to launch WounDerm services to gather patient data, aiming to improve product effectiveness and reduce healthcare costs [79]. Market Opportunities - The annual treatment cost for all wounds in the U.S. is approximately $28 billion, with surgical site infections costing between $3.5 billion and $10 billion annually [32]. - Approximately 15% of the Medicare beneficiary population has chronic nonhealing wounds, indicating a significant market opportunity for wound care products [49]. - Over 34 million people in the U.S., or approximately 10% of the population, suffer from diabetes, which can lead to diabetic foot ulcers (DFUs) that are difficult to heal [50]. - Venous leg ulcers (VLUs) affect approximately 600,000 people annually in the U.S., highlighting a substantial patient base for targeted treatments [51]. - Annually, 2.5 million pressure ulcers are treated in acute care facilities in the U.S., representing a critical area for intervention [52]. Acquisitions and Partnerships - The company acquired Precision Healing Inc. in April 2022, which is developing a diagnostic imager and lateral flow assay for wound assessment, with 510(k) submissions planned for 2023 [23]. - Following the acquisition of Scendia in July 2022, the company expanded its product offerings to include regenerative and orthobiologic technologies [24]. - The company plans to establish partnerships with Medicare Advantage and other healthcare at-risk models to improve outcomes and lower wound care costs [43]. - The company acquired certain assets from Rochal in July 2021, including eight issued U.S. patents and over 100 issued patents in foreign jurisdictions, expanding its patent portfolio significantly [70]. Regulatory Compliance - The company’s operations are subject to comprehensive federal, state, and local laws and regulations, which are frequently changing and may impact profitability [97]. - The FDA has 180 days to complete its review of a PMA application, although the review often takes significantly longer [104]. - The company must comply with federal truth-in-advertising laws enforced by the FTC, which can result in penalties for non-compliance [112]. - The PMA process requires extensive data, including preclinical studies and clinical trials, to demonstrate that a device is safe and effective [104]. - Non-compliance with regulatory requirements can lead to severe consequences, including fines, product seizures, and injunctions against manufacturing or distributing products [195]. Financial Performance and Risks - The company has a history of losses, which may continue as it expands its selling efforts [134]. - Revenue growth for a particular period is difficult to predict, and a shortfall in forecasted revenues may harm operating results [134]. - The company relies heavily on research and development partners to design, manufacture, and supply licensed products, and any failure could incur significant costs and delays [135]. - Economic conditions, including inflation and changes in reimbursement rates, could affect the ability of surgical facilities to purchase products, impacting revenue [142]. - The company faces competition from larger companies in the wound care market, including Smith & Nephew plc and 3M Company, which have greater financial resources [80]. Intellectual Property and Licensing - The company relies on patents and other legal protections for its technologies, but these may not provide sufficient competitive advantages or prevent competitors from entering the market [174]. - The company relies heavily on licensed technologies and products from third parties, and failure to comply with licensing agreements could halt the development and commercialization of its products [180]. - There is no assurance that existing licensing agreements will be extended on reasonable terms, which could impact the company's ability to generate revenue and meet payment obligations [181]. - CellerateRX Surgical currently has no patent protection, which may expose the company to competition from equivalent products, potentially adversely affecting its business and financial condition [179]. Telehealth and Virtual Services - The U.S. teledermatology market is projected to grow from $5 billion in 2019 to $45 billion by 2027 [32]. - The anticipated launch of wound and skincare virtual consult services may face competition from other telehealth providers, impacting financial performance [146]. - The company's telehealth business expansion is dependent on maintaining relationships with affiliated professional entities, and disruptions in these relationships could adversely affect operations [171]. - Recent state legislative changes regarding telemedicine may impose additional compliance costs and operational impacts, potentially affecting service availability [173]. Supply Chain and Manufacturing - The company experienced supply issues with the ALLOCYTE product line during Q3 2022, which negatively impacted sales, but anticipates resolution in the second half of 2023 [76]. - The company relies on contract manufacturing to avoid high capital outlays and fixed costs associated with establishing its own manufacturing facilities [75]. - Disruptions in the supply of tissues are negatively impacting the inventory of ALLOCYTE, which could materially affect the company's financial condition and results of operations [163]. - Increased prices or unavailability of raw materials could adversely affect profitability, as the company may not be able to pass on cost increases to customers [168]. Employee and Operational Structure - As of December 31, 2022, the company had a total of 101 full-time employees and 2 part-time employees [130]. - As of December 31, 2022, the company employed 39 field sales representatives and continuously evaluates new markets and sales opportunities [72]. - The company plans to increase the scope of operations rapidly, which may strain internal resources and require effective management of growth [144].
Sanara MedTech(SMTI) - 2022 Q3 - Earnings Call Transcript
2022-11-15 18:59
Sanara Medtech, Inc. (NASDAQ:SMTI) Q3 2022 Earnings Conference Call November 15, 2022 9:00 AM ET Company Participants Callon Nichols - Director, IR Ronald Nixon - Executive Chairman Zachary Fleming - CEO Michael McNeil - CFO & Corporate Secretary Conference Call Participants Christopher Plahm - Tall Pines Capital Ian Cassel - MicroCapClub Operator Good day, ladies and gentlemen, and welcome to the Sanara MedTech Inc. Q3 2022 Earnings and Business Update. [Operator Instructions]. It is now my pleasure to tur ...
Sanara MedTech(SMTI) - 2022 Q3 - Quarterly Report
2022-11-14 21:03
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or For the transition period from ________ to ________ Commission File Number 001-39678 SANARA MEDTECH INC. (Exact name of Registrant as specified in its charter) | Texas | 59-2219994 | | --- | --- | | (St ...
Sanara MedTech(SMTI) - 2022 Q2 - Earnings Call Transcript
2022-08-16 17:28
Sanara MedTech Inc. (NASDAQ:SMTI) Q2 2022 Earnings Conference Call August 16, 2022 9:00 AM ET Company Participants Callon Nichols - Director of IR Ron Nixon - Executive Chairman Zachary Fleming - CEO Michael McNeil - CFO Conference Call Participants Ross Osborn - Cantor Fitzgerald Ian Cassel - IFCM Operator Good morning, ladies and gentlemen, and welcome to the Sanara MedTech Inc. Second Quarter 2022 Earnings and Business Update. At this time, all participants have been placed on a listen-only mode and the ...