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Sanara MedTech(SMTI) - 2021 Q4 - Earnings Call Transcript
2022-03-31 15:51
Financial Data and Key Metrics Changes - In Q4 2021, the company generated $7 million in revenue with a net loss of $3.6 million. For the full year, revenues reached $24.1 million, marking a 55% increase from the previous year. The net loss for 2021 was $8 million, compared to a net loss of $4.4 million in 2020 [6][14][17]. Business Line Data and Key Metrics Changes - The surgical team achieved record sales in both Q4 and the full year, with Cellerate being sold in 471 hospitals and ASCs across 26 states by the end of Q4 2021. The company was approved to sell in approximately 1,100 facilities during the year [10][11]. - Two new products, FORTIFY TRG Tissue Repair Graft and FORTIFY FLOWABLE Extracellular Matrix, were launched, with initial sales of FORTIFY TRG occurring in Q4 [11]. Market Data and Key Metrics Changes - The company reported strong demand for its products, with December 2021 being a record sales month. The expansion of geographic coverage and penetration into more hospitals contributed to this performance [11][28]. Company Strategy and Development Direction - The company is focusing on expanding its sales force and distribution network in both new and existing U.S. markets. The WounDerm platform is being integrated with Homecare Homebase, the largest EHR provider in the home health market [12][14]. - The Precision Healing Imager is being prepared for FDA submission, with a strategic decision made to file with the commercial unit design [12]. Management's Comments on Operating Environment and Future Outlook - Management indicated that the operating environment is returning to normal, with no unusual disruptions affecting business operations. The strategy is being executed effectively, and the company is optimistic about future growth [31][32]. Other Important Information - The company made leadership changes, promoting Zach Fleming to CEO and adding new board members to strengthen the team [7][8]. - Cash on hand at the end of 2021 was $18.7 million, with cash used in operating activities for the full year amounting to $4.8 million [17]. Q&A Session Summary Question: Was there anything abnormal about Q4 that positively skewed the results? - Management confirmed there was nothing unusual, attributing the performance to an increase in surgeries as COVID-related restrictions eased [24]. Question: What is the normal cadence in the year regarding sales? - Management noted that Q4 tends to be strong due to patients reaching their deductibles, while Q3 is typically weaker due to vacations [26]. Question: Did COVID impact January's performance? - Management stated that they did not see any significant disruptions in January, indicating business as usual [29]. Question: Can you explain the expansion of the WounDerm pilot? - An agency refers to the location of a home healthcare company, typically covering a 50-mile radius for patient populations [34]. Question: Can you comment on January, February, March trends? - Management avoided giving forward-looking statements but reiterated that they are continuing to execute their strategy without disruptions [37]. Question: How does Precision Healing fit into the long-term strategy? - Precision Healing is seen as critical for developing precise treatment protocols and is expected to be reimbursed under existing codes [42]. Question: Is there potential for licensing Precision Healing internationally? - Management indicated that they have not explored licensing yet but see potential opportunities for partnerships [44]. Question: Can you explain the partnership with Scendia Biologics? - The partnership aims to offer complementary products that enhance surgical outcomes, with a joint venture established for growth [46]. Question: Which product in development excites you the most? - Management expressed excitement about both BIASURGE and Precision Healing, viewing them as potential game changers in their respective markets [48][49]. Question: How does the acquisition of a home health provider by a major insurer affect your business? - Management sees every home healthcare provider as a potential partner, and the trend of vertical integration is viewed positively for their strategy [52].
Sanara MedTech(SMTI) - 2021 Q4 - Annual Report
2022-03-30 23:50
Market Opportunity - Approximately 8.2 million patients in the U.S. suffer from surgical and chronic wounds annually, with total treatment costs estimated at $28 billion[20] - The U.S. teledermatology market is projected to grow from $5 billion in 2019 to $45 billion by 2027, indicating significant market expansion opportunities[20] - Chronic wounds affect approximately 15% of the Medicare beneficiary population, highlighting a significant target market for the company's products[31] - Over 34 million people in the U.S., approximately 10% of the population, suffer from diabetes, leading to complications such as diabetic foot ulcers (DFUs)[32] Product Development and Pipeline - The company focuses on developing transformative technologies for surgical and chronic wound care, aiming to improve clinical outcomes and reduce healthcare costs[16] - The company is developing a robust pipeline of products for chronic and surgical wound care, including antimicrobial skin protectants and next-generation offerings[25] - The company acquired assets from Rochal, including four FDA 510(k) clearances, enhancing its product pipeline for wound care[19] - The company plans to fully commercialize three products with Cook Biotech in 2022, which are already cleared for surgical wound care[24] - The product pipeline includes candidates for mitigating opportunistic pathogens, wound re-epithelialization, and necrotic tissue debridement[144] Clinical Efficacy - A study showed that using CellerateRX Surgical powder resulted in a 0% rate of wound dehiscence or infection in neurosurgery cases, compared to infection rates as high as 24% in similar surgeries[35] - The BIAKŌS system demonstrated a >99.99% reduction in biofilm burden within 24 hours, outperforming commercial controls[42] Regulatory Compliance - The company’s medical products are regulated by the FDA, requiring marketing clearance or approval before introduction into the U.S. market[80] - The PMA process requires manufacturers to demonstrate safety and effectiveness through extensive data, including preclinical studies and clinical trials, with a review period that can take up to several years[85] - Compliance with FDA's current good manufacturing practices (cGMP) is essential, and any failure could jeopardize product commercialization[141] - The company is subject to comprehensive federal, state, and local laws and regulations, which are subject to frequent change[79] Financial Performance and Risks - The company has a history of losses, which may continue as it expands its selling efforts[116] - The company’s revenue growth is difficult to predict, and a shortfall in forecast revenues may harm its operating results[116] - The company has incurred net losses in most years since 2004 and plans to continue significant investments in its sales force and clinical programs, which will increase operating expenses[120] - The company may need to seek additional financing to meet capital requirements[125] Competition and Market Challenges - The company faces competition from large, established medical device manufacturers and telehealth providers, which could adversely affect its financial condition[116] - The company faces significant competition in the wound care sector, with many competitors having greater resources and established collaborations[148] - The company’s planned expansion into wound and skin care virtual consult services will require entering markets with little or no experience[117] Telehealth and Technology Integration - A pilot program for telehealth services conducted in Q4 2021 showed positive results, with plans to expand to six more agencies in Q1 2022[30] - The company is developing a comprehensive service offering through WounDerm, which includes an EMR software platform and virtual consultation services, expected to be commercially available in mid-2022[49][50] - The Precision Healing product platform, designed for wound assessment, is anticipated to be commercially available in 2023 and will integrate with the WounDerm EMR[53] Compliance and Legal Risks - The company is subject to various healthcare fraud and abuse laws, and failure to comply could result in substantial penalties[121] - Non-compliance with healthcare fraud and abuse laws could result in substantial penalties for the company[191] - The company must comply with HIPAA regulations regarding the protection of personally identifiable information (PII) and protected health information (PHI), with mandatory penalties for violations[197] Operational and Management Challenges - The company’s ability to manage growth effectively is critical, as future expansion efforts may strain internal resources[128] - The company may face challenges in attracting and retaining key personnel, which could adversely affect its business[127] - Effective management of product inventory is crucial, as products have a shelf life of 18 months to three years, impacting profitability[150] Reimbursement and Financial Viability - A significant portion of the company's wound care products are reimbursed under Medicare Part B, making reimbursement policies critical for market opportunities[184] - Changes in reimbursement policies by third-party payors could adversely affect the company's ability to market products and generate revenue[183] Future Outlook and Strategic Initiatives - The company is exploring new indications of use and improved formulas for next-generation products, including CellerateRX and HYCOL[86] - The company’s comprehensive wound and skin care strategy involves growth through acquisitions and investments, which requires incurring substantial costs[116]
Sanara MedTech(SMTI) - 2021 Q3 - Earnings Call Transcript
2021-11-15 19:16
Sanara MedTech Inc. (NASDAQ:SMTI) Q3 2021 Earnings Conference Call November 15, 2021 9:00 AM ET Company Participants Callon Nichols - Director of IR Ron Nixon - Chairman of our Board Zachary Fleming - President of Surgical Mike McNeil - CFO Conference Call Participants Ian Cassel - MicroCapClub Evan Claar - CBI Capital Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio s ...
Sanara MedTech(SMTI) - 2021 Q3 - Quarterly Report
2021-11-12 21:01
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, 2021 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) (State or other jurisdiction of incorporat ...
Sanara MedTech(SMTI) - 2021 Q2 - Earnings Call Transcript
2021-08-17 21:25
Sanara MedTech Inc. (NASDAQ:SMTI) Q2 2021 Earnings Conference Call August 17, 2021 9:00 AM ET Company Participants Callon Nichols - Director of Investor Relations Ron Nixon - Chairman of our Board Mike McNeil - Chief Financial Officer Zack Fleming - President of Surgical Conference Call Participants Brandon Folkes - Cantor Fitzgerald Neil Cataldi - Blueprint Capital Management Operator Good day, ladies and gentlemen, and welcome to the Sanara MedTech Inc. Second Quarter 2021 Results and Business Update Con ...
Sanara MedTech(SMTI) - 2021 Q2 - Quarterly Report
2021-08-16 20:02
☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-39678 SANARA MEDTECH INC. For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation o ...
Sanara MedTech(SMTI) - 2021 Q1 - Quarterly Report
2021-05-14 20:02
Financial Performance - For the three months ended March 31, 2021, the company generated revenues of $5,009,436, a 42% increase from $3,524,331 for the same period in 2020[122] - Surgical product sales amounted to $4,711,613 for the three months ended March 31, 2021, compared to $3,272,892 in the prior year[116] - The company reported a net loss of $1,183,376 for the three months ended March 31, 2021, an improvement from a net loss of $1,841,012 in the same period of 2020[127] - Cost of goods sold for the three months ended March 31, 2021, was $474,433, up from $330,188 in the same period of 2020, primarily due to higher sales volume[123] - For the three months ended March 31, 2021, net cash used in operating activities was $1,261,604, a decrease from $2,032,019 for the same period in 2020, primarily due to higher sales revenue[134] - Net cash provided by financing activities for the three months ended March 31, 2021 was $28,739,257, compared to $0 for the same period in 2020, driven by proceeds from an underwritten public offering of 1,265,000 shares at $25.00 per share, resulting in gross proceeds of $31,625,000[136] Research and Development - Research and development expenses increased to $118,212 for the three months ended March 31, 2021, from $4,387 in the same period of 2020, due to new studies and development projects[125] - The company has multiple products in its pipeline and intends to begin marketing two biologic products for surgical and wound care applications in 2021[108] Cash and Financing - Cash on hand at March 31, 2021, was $27,328,628, a significant increase from $455,366 at December 31, 2020[129] - The company anticipates using net proceeds from a public offering of 1,265,000 shares at $25.00 per share to expand its salesforce and further develop its product pipeline[129] Expenses and Costs - The company expects SG&A expenses to increase in absolute dollars but decrease as a percentage of revenue as the commercial organization grows[119] - The company incurred $148,521 in costs for technical services provided by Rochal for the three months ended March 31, 2021[142] - The company recorded inventory obsolescence expense of $7,312 for the three months ended March 31, 2021, compared to $20,116 for the same period in 2020[152] Licensing and Agreements - The company has an exclusive world-wide license to market and sell antimicrobial products under the BIAKŌS License Agreement, with a payment of $750,000 made in March 2021 through the issuance of 20,834 shares of common stock[133] - The company amended the CellerateRX sublicense agreement to extend the term to May 17, 2050, with minimum royalties of $400,000 per year for the first five years[137] - The company acquired Catalyst's 50% interest in Cellerate, LLC in exchange for 1,136,815 shares of Series F Convertible Preferred Stock[139] Other Information - Royalties due under the CellerateRX sublicense agreement for the three months ended March 31, 2021 totaled $192,586, up from $100,000 for the same period in 2020[137] - As of March 31, 2021, there were no related party promissory notes or accrued interest outstanding following the conversion of a $1,500,000 promissory note into common stock[140] - The company does not anticipate that inflation and changing prices will have a material impact on future results of operations[145]
Sanara MedTech(SMTI) - 2020 Q4 - Annual Report
2021-03-30 20:48
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☑ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 ------------------------------------------------------ Commission File Number 001-39678 SANARA MEDTECH INC. (Exact name of Registrant as specified in its charter) | Texas | | 59-2219994 | | --- | --- | --- | | (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identificat ...
Sanara MedTech(SMTI) - 2020 Q3 - Quarterly Report
2020-11-13 21:33
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2020 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 No. 001-39678 SANARA MEDTECH INC. (Exact name of registrant as specified in its charter) Texas 59-2219994 (State or ot ...
Sanara MedTech(SMTI) - 2020 Q2 - Quarterly Report
2020-08-13 13:31
U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (State or other jurisdiction of incorporation or FORM 10-Q (Mark One) [X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2020 or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 0-11808 SANARA MEDTECH INC. (Exact name of registrant as specified in its charter) Texas 59-2219994 organization) (I.R.S. Employer ...