Sensus Healthcare(SRTS)
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Sensus Healthcare(SRTS) - 2023 Q1 - Earnings Call Transcript
2023-05-04 02:40
Financial Data and Key Metrics Changes - Revenues for Q1 2023 were $3.4 million, down from $10.3 million in Q1 2022, primarily due to a lower number of SRT units sold and inflation impacts on medical practices [31][32] - Gross profit for Q1 2023 was $1.6 million, or 47.1% of revenues, compared to $7.1 million, or 68.9% of revenues in the previous year, reflecting lower unit sales and higher vendor costs [32] - Net loss for Q1 2023 was $1.9 million, or $0.12 per share, compared to net income of $16.1 million, or $0.97 per diluted share in Q1 2022, which included a $12.8 million gain on the sale of a non-core asset [36][37] Business Line Data and Key Metrics Changes - Selling and marketing expenses increased to $2.1 million in Q1 2023 from $1.2 million in Q1 2022, attributed to higher advertising expenses and increased participation in targeted tradeshows [33] - Research and development expenses rose to $1.1 million in Q1 2023 from $0.7 million in the same quarter last year, mainly due to ongoing aesthetic project expenses [35] Market Data and Key Metrics Changes - The compounded annual growth rate for SRT reimbursement has been 27% year-over-year for the past six years, while Mohs surgery has only grown at 5% during the same period [20] - The company is witnessing increased interest in its SRT systems in Asian markets, having shipped its first system to Taiwan and two systems to China in Q1 2023 [19] Company Strategy and Development Direction - The company is focusing on addressing customer hesitancies due to inflation by building inventory and prepaying for components, expecting to ship over 60 systems in 2023 [10][11] - Sensus Healthcare is expanding its presence in smaller regional conferences to connect more closely with customers and is also targeting the radiation oncology segment for skin cancer treatments [14][15][24] Management's Comments on Operating Environment and Future Outlook - Management views the current hesitancy in purchasing decisions as a temporary operating environment influenced by inflation affecting dermatology practices [10][12] - The company remains optimistic about future growth, emphasizing the importance of its proprietary Sentinel IT solutions and the potential for increased sales as the market adjusts to current economic conditions [42][48] Other Important Information - Cash and cash equivalents were $19.3 million as of March 31, 2023, down from $25.5 million at the end of 2022, while inventory increased to $6.3 million from $3.5 million [38][39] - The company is actively engaging in discussions to open new international territories, particularly in Asia and South America, with Brazil identified as a significant market opportunity [27][28] Q&A Session Summary Question: How is inflation impacting customer purchasing decisions? - Management explained that inflation is affecting consumers' discretionary spending on elective procedures, leading to hesitancy in purchasing SRT systems [53][56] Question: What were the service revenues in the quarter? - Service revenue accounted for approximately 28% of total revenue in the quarter [63] Question: What is the outlook for Q2? - Management anticipates Q2 to be another challenging quarter, but expects gradual improvement as customers adapt to the inflationary environment [71][80] Question: What is the company's strategy for international expansion? - The company is focusing on regulatory approvals and engaging the right distributors to expand into Asian markets, with specific targets on Korea and Japan [27][126] Question: What are the plans for the drug delivery system? - The drug delivery system is close to submission for FDA approval, with expectations for submission within the current quarter [99]
Sensus Healthcare(SRTS) - 2022 Q4 - Annual Report
2023-03-23 18:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2022 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: 001-37714 Sensus Healthcare, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1647271 (State or ot ...
Sensus Healthcare(SRTS) - 2022 Q4 - Earnings Call Transcript
2023-02-10 03:00
Sensus Healthcare, Inc. (NASDAQ:SRTS) Q4 2022 Earnings Conference Call February 9, 2023 4:30 PM ET Company Participants Kim Golodetz - Lippert/Heilshorn & Associates Joseph Sardano - Co-Founder, Chairman & CEO Michael Sardano - President & General Counsel Javier Rampolla - CFO Conference Call Participants Benjamin Haynor - Alliance Global Partners Alexander Nowak - Craig-Hallum Scott Henry - ROTH MKM Partners Anthony Vendetti - Maxim Group Operator Welcome to the Sensus Healthcare Fourth Quarter 2022 Earnin ...
Sensus Healthcare(SRTS) - 2022 Q3 - Quarterly Report
2022-11-10 19:22
PART I – Financial Information [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended September 30, 2022, reflect significant growth in assets, revenue, and profitability, including a $21.4 million net income driven by an asset sale [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2022, the balance sheet shows a 70% increase in total assets to $54.8 million, driven by a surge in cash and a substantial rise in stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Financial Metric | Sep 30, 2022 (unaudited) | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,577 | $14,519 | | Total current assets | $51,530 | $31,245 | | Total assets | $54,759 | $32,240 | | **Liabilities & Equity** | | | | Total current liabilities | $6,584 | $5,963 | | Total liabilities | $7,635 | $6,225 | | Retained earnings (Accumulated deficit) | $3,473 | $(17,942) | | Total stockholders' equity | $47,124 | $26,015 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations reveal substantial revenue growth and a significant profitability turnaround for the three and nine months ended September 30, 2022, largely due to an asset sale Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | 9 Months 2022 | 9 Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $9,010 | $5,525 | $31,428 | $14,017 | | Gross Profit | $5,874 | $3,201 | $21,278 | $8,132 | | Income (loss) from operations | $2,161 | $195 | $10,659 | $(1,199) | | Gain on sale of assets | - | - | $12,779 | - | | Net income (loss) | $1,829 | $195 | $21,415 | $(1,199) | | Diluted EPS | $0.11 | $0.01 | $1.28 | $(0.07) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased by $23.1 million for the nine months ended September 30, 2022, driven by strong operating cash flow and a significant asset sale Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $8,701 | $1,494 | | Net cash provided by investing activities | $14,851 | $167 | | Net cash used in financing activities | $(494) | $(177) | | **Net increase in cash and cash equivalents** | **$23,058** | **$1,484** | - The primary driver of investing cash flow was the **$15.0 million** received from the sale of the Sculptura assets[20](index=20&type=chunk)[51](index=51&type=chunk) - Financing activities included a **$1.0 million repurchase** of common stock and **$0.7 million in proceeds** from the exercise of stock options[20](index=20&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on accounting policies, significant events including a $15 million asset sale, revenue concentration, and an ongoing Department of Justice investigation - On February 25, 2022, the Company sold its Sculptura assets for **$15 million in cash**, recognizing a **$12.8 million gain**[51](index=51&type=chunk) - The U.S. market is the primary source of revenue, accounting for **95% of total revenue** for the nine months ended September 30, 2022, with a single U.S. customer accounting for **73% of revenue** in the same period[36](index=36&type=chunk) - The company is cooperating with a **Department of Justice investigation** into billing practices by a physician who used the company's SRT-100 device, disputing any wrongdoing and unable to estimate potential costs[67](index=67&type=chunk) - In Q1 2022, the company released a **$3.7 million valuation allowance** against its deferred tax assets, concluding it is more likely than not that these assets will be realized[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong financial performance for the first nine months of 2022, driven by increased sales, expanded gross margins, and enhanced liquidity from an asset sale [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Results of operations show significant revenue growth and gross margin expansion for both the third quarter and nine months ended September 30, 2022, driven by higher unit sales Q3 2022 vs Q3 2021 Performance (in millions) | Metric | Q3 2022 | Q3 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $9.0 | $5.5 | +63.6% | | Gross Profit | $5.9 | $3.2 | +84.4% | | Gross Margin | 65.6% | 57.9% | +7.7 p.p. | | Selling & Marketing Expense | $1.8 | $1.2 | +50.0% | Nine Months 2022 vs 2021 Performance (in millions) | Metric | 9M 2022 | 9M 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $31.4 | $14.0 | +124.3% | | Gross Profit | $21.3 | $8.1 | +163.0% | | Gross Margin | 67.8% | 58.0% | +9.8 p.p. | | Selling & Marketing Expense | $4.8 | $3.5 | +37.1% | [Financial Condition, Liquidity and Capital Resources](index=21&type=section&id=Financial%20Condition%2C%20Liquidity%20and%20Capital%20Resources) The company's financial condition and liquidity significantly improved, with cash and cash equivalents increasing by $23.1 million, supported by strong operating cash flow and an asset sale - Cash and cash equivalents increased by **$23.1 million** from December 31, 2021, to September 30, 2022[103](index=103&type=chunk) - Net cash provided by operating activities was **$8.7 million** for the nine months ended September 30, 2022, compared to **$1.5 million** in the prior year period[108](index=108&type=chunk) - Net cash from investing activities was **$14.9 million**, primarily from the sale of assets[109](index=109&type=chunk) - There were **no borrowings** under the revolving line of credit as of September 30, 2022[105](index=105&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable for the company as a smaller reporting company - The company stated that this section is not applicable[114](index=114&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2022, with no significant changes to internal control over financial reporting - Based on an evaluation as of September 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective**[116](index=116&type=chunk) - **No significant changes** were made to the internal control over financial reporting during the third quarter of 2022[117](index=117&type=chunk) PART II – Other Information [Item 1. Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in ordinary course legal proceedings and refers to the financial statement notes for details on commitments and contingencies, including a DOJ investigation - The company is involved in **ordinary course legal proceedings** and directs readers to the Commitments and Contingencies note in the financial statements for more details[67](index=67&type=chunk)[120](index=120&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) No new risk factors are presented in this report, with investors directed to previously disclosed risks in the 2021 Annual Report and subsequent filings - The company refers to the risk factors disclosed in its 2021 Annual Report and subsequent quarterly reports, with **no new additions** in this filing[121](index=121&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities, no use of proceeds from registered sales, and no equity security purchases during the nine months ended September 30, 2022 - There were **no unregistered sales** of securities during the nine months ended September 30, 2022[122](index=122&type=chunk) [Item 3. Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[124](index=124&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205.%20Other%20Information) No other information required to be disclosed under this item was reported - None[126](index=126&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - The exhibits filed include **certifications from the CEO and CFO**, along with **XBRL data files**[127](index=127&type=chunk)
Sensus Healthcare(SRTS) - 2022 Q3 - Earnings Call Transcript
2022-11-06 16:56
Sensus Healthcare, Inc. (NASDAQ:SRTS) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Kim Golodetz - Investor Relations Joe Sardano - Chairman and Chief Executive Officer Michael Sardano - President and General Counsel Javier Rampolla - Chief Financial Officer Conference Call Participants Scott Henry - Roth Capital Yi Chen - H.C. Wainwright Benjamin Haynor - Alliance Global Partners Anthony Vendetti - Maxim Group Operator Hello and welcome to the Sensus Healthcare Third Qua ...
Sensus Healthcare(SRTS) - 2022 Q2 - Quarterly Report
2022-08-12 17:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 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: 001-37714 Sensus Healthcare, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1647271 (State o ...
Sensus Healthcare(SRTS) - 2022 Q2 - Earnings Call Transcript
2022-08-07 12:02
Sensus Healthcare, Inc. (NASDAQ:SRTS) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Kim Golodetz - Senior Vice President and Principal, Lippert/Heilshorn & Associates Inc. Joe Sardano - Chairman & Chief Executive Officer Javier Rampolla - Chief Financial Officer Conference Call Participants Scott Henry - ROTH Capital Anthony Vendetti - Maxim Group Operator Good day ladies and gentlemen and welcome to the Sensus Healthcare Second Quarter 2022 Earnings Conference Call. [Opera ...
Sensus Healthcare(SRTS) - 2022 Q1 - Quarterly Report
2022-05-12 20:23
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 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: 001-37714 Sensus Healthcare, Inc. (Exact name of registrant as specified in its charter) | Delaware | 27-1647271 | | ...
Sensus Healthcare(SRTS) - 2022 Q1 - Earnings Call Transcript
2022-05-08 13:23
Financial Data and Key Metrics Changes - Revenues for Q1 2022 were $10.3 million, more than three times the $3.1 million reported in Q1 2021 [6][28] - Net income for Q1 2022 was $16.1 million or $0.97 per diluted share, compared to a net loss of $1.1 million or $0.07 per share in Q1 2021 [31] - Gross profit for Q1 2022 was $7.1 million, representing 69.1% of revenues, up from $1.6 million or 51.6% of revenues in Q1 2021 [29] Business Line Data and Key Metrics Changes - A total of 33 units were shipped in Q1 2022, including 26 SRT systems and 7 TransDermal Infusion Systems [9][28] - Approximately 50% of customers purchased extended warranty service agreements, up from 25% a few years ago [14] Market Data and Key Metrics Changes - One SRT unit was delivered to China, and regulatory approval was received to treat non-melanoma skin cancer and keloids with SRT in Taiwan [23] - The company hired nine sales representatives and two service engineers, returning the sales organization to pre-pandemic levels [24] Company Strategy and Development Direction - The company is focusing on expanding its product portfolio and has initiated a $3 million share repurchase program [15][34] - An exclusive US distribution agreement for a non-invasive drug delivery system, branded as Transdermal Infusion Systems, was established [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued profitability for the year, citing a robust backlog of orders and effective expense management [27] - The company is aware of potential threats such as inflation and geopolitical turmoil but remains confident in its sales and earnings trajectory [26] Other Important Information - The company emphasized the importance of in-person meetings for solidifying customer relationships and generating sales leads [22] - The management highlighted the positive impact of improved CMS reimbursement codes on patient access to care [9] Q&A Session Summary Question: What contributed to the acceleration in demand for SRT? - Management indicated that the increase was due to a combination of better reimbursement, fair market value leasing, and best practice conversion [41][42][43] Question: How aware are sales reps of the reimbursement changes? - Management stated that all salespeople are thoroughly trained on reimbursement changes and are actively educating doctors [44][45] Question: What additional products are being considered for expansion? - Management mentioned that targets for new products will be those that can be easily integrated into existing sales discussions with dermatology practices [46][47] Question: Can the growth from the Transdermal System be quantified? - Management noted that seven units shipped in Q1 represented about 20-22% of overall shipments, indicating strategic placement with key opinion leaders [48][49] Question: What is the business model for the Transdermal System? - Management confirmed that the selling price is expected to be around $32,000 to $35,000, with consumables available for patient-specific use [53][54] Question: How was the traffic and interest at recent conferences? - Management reported high interest and positive feedback from attendees at the AAD and ASLMS conferences, with many customers looking to purchase additional units [55][56] Question: When were the new hires made? - Most of the hiring occurred after Q1, with a focus on expanding the sales force throughout the year [59]
Sensus Healthcare(SRTS) - 2021 Q4 - Annual Report
2022-03-25 20:03
Part I [Business](index=5&type=section&id=Item%201.%20Business) Sensus Healthcare specializes in superficial radiation therapy (SRT) for skin conditions, selling SRT-100 products and services, and sold Sculptura assets for $15 million - The company's core business provides non-invasive treatments for oncological and non-oncological skin conditions using proprietary superficial radiation therapy (SRT) technology[22](index=22&type=chunk) - On February 25, 2022, the company sold its Sculptura product assets for **$15 million** in cash[23](index=23&type=chunk) - Primary revenue derives from the sale of its SRT-100 product line, including SRT-100, SRT-100+, and SRT-100 Vision models[25](index=25&type=chunk) - As of December 31, 2021, Sensus had an installed base of **564 units** across **18 countries**, primarily in the United States[39](index=39&type=chunk) [Our Products and Services](index=5&type=section&id=Our%20Products%20and%20Services) The company's portfolio centers on SRT devices (SRT-100, Vision, 100+), complemented by a 'Sentinel' service program, aesthetic laser rentals, and consumables - The SRT-100 is a photon x-ray low energy superficial radiotherapy system, offering a surgical alternative for non-melanoma skin cancers and keloids[25](index=25&type=chunk) - The SRT-100 Vision enhances the base model with integrated high-frequency ultrasound imaging for precise treatment planning and tumor analysis[27](index=27&type=chunk) - In August 2020, the company acquired two mobile aesthetic laser companies, now SLAS, to offer in-office laser rental services in Florida[31](index=31&type=chunk) [Sales and Marketing](index=7&type=section&id=Sales%20and%20Marketing) Sensus uses a multi-tier sales strategy with a direct U.S. force and international dealers, targeting dermatology and radiation oncology markets, with growth potential in plastic surgery - The company utilizes a multi-tier sales model with a direct U.S. sales force and international dealers/distributors[35](index=35&type=chunk) - Primary target markets are private dermatology practices and radiation oncologists, with SRT products enabling dermatologists to retain patients[35](index=35&type=chunk)[36](index=36&type=chunk) - The company is expanding into the plastic surgery market, leveraging FDA clearance for treating keloids with SRT[38](index=38&type=chunk) [Manufacturing and Supply](index=8&type=section&id=Manufacturing%20and%20Supply) Sensus outsources SRT-100 manufacturing to RbM Services, LLC in the U.S., minimizing capital investment, and relies on a single preferred supplier for key components - Sensus uses a third-party manufacturer, RbM Services, LLC, in the U.S. to produce SRT-100 products under a fixed-price per unit agreement[40](index=40&type=chunk) - The company has a single preferred supplier for x-ray tubes and other major components, but believes adequate alternate suppliers exist, mitigating supply risk[43](index=43&type=chunk) [Intellectual Property](index=8&type=section&id=Intellectual%20Property) Sensus protects its technology with U.S. and international patents expiring until 2038, 22 pending applications, seven U.S. trademarks, and confidentiality agreements - The company holds multiple U.S. and international patents for its technology, with some expiring as late as **2038**[46](index=46&type=chunk)[50](index=50&type=chunk) - As of December 31, 2020, the company had **22 pending patent applications** and **seven registered U.S. trademarks**[47](index=47&type=chunk) [Government Regulation](index=10&type=section&id=Government%20Regulation) Sensus operates under extensive FDA (Class II, 510(k) clearance, QSR, MDR) and international regulations (CE mark), plus federal and state anti-kickback, false claims, and HIPAA laws - The company's medical devices are classified as **Class II** by the FDA, with marketing authorization via **510(k) clearance**[53](index=53&type=chunk)[55](index=55&type=chunk) - Sensus is subject to extensive ongoing FDA regulation, including Quality System Regulation (QSR), labeling, and Medical Device Reporting (MDR) for adverse events[56](index=56&type=chunk) - The company has obtained regulatory approvals to sell products in numerous international markets, including Australia, Canada, China, and Europe (CE mark)[61](index=61&type=chunk) - The business must comply with federal and state anti-kickback laws, false claims acts, and physician self-referral laws (Stark Law)[62](index=62&type=chunk)[63](index=63&type=chunk)[68](index=68&type=chunk) [Employees and Human Capital](index=14&type=section&id=Employees%20and%20Human%20Capital) As of December 31, 2021, Sensus had **37 employees**, primarily in the U.S., with no union representation, and implemented COVID-19 safety measures - At the end of 2021, the company had **37 employees**, primarily based in the U.S. (**33**) and Israel (**4**)[73](index=73&type=chunk) - In response to the COVID-19 pandemic, the company implemented safety protocols including remote work and facemasks[76](index=76&type=chunk) [Risk Factors](index=15&type=section&id=Item%201A.%20Risk%20Factors) The company faces multiple risks in business operations, regulatory compliance, intellectual property, and stock ownership [Risks Related to our Business](index=15&type=section&id=Risks%20Related%20to%20our%20Business) Business risks include dependence on third-party payor reimbursement, COVID-19 impacts, reliance on the SRT-100 product line, significant customer concentration, and a single preferred supplier - The business is highly dependent on coverage and adequate reimbursement from third-party payors like Medicare and private insurers[80](index=80&type=chunk) - The COVID-19 pandemic has impacted sales and could continue to adversely affect business operations and supply chains[84](index=84&type=chunk) - The company has significant customer concentration, with one U.S. customer accounting for approximately **57% of revenues in 2021** and **40% in 2020**[94](index=94&type=chunk) - Sensus relies on a single preferred supplier for x-ray tubes and other major components, and its loss could hinder production[92](index=92&type=chunk) [Risks Related to our Regulatory Environment](index=19&type=section&id=Risks%20Related%20to%20our%20Regulatory%20Environment) Regulatory risks include compliance with federal and state healthcare laws (Anti-Kickback, Sunshine, False Claims), medical device reporting, and potential adverse impacts from healthcare policy changes - The company is subject to various healthcare laws, including the Federal Anti-Kickback Statute, 'Sunshine' Act, and False Claims laws, with potential significant penalties for violations[100](index=100&type=chunk)[103](index=103&type=chunk) - Sensus must comply with medical device reporting regulations in the U.S. and Europe for malfunctions, deaths, or serious injuries[105](index=105&type=chunk) - Changes in healthcare policy, including Medicare reimbursement reforms or cost-containment measures, could materially adversely affect the business[107](index=107&type=chunk)[108](index=108&type=chunk) [Risks Related to our Intellectual Property](index=21&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) IP risks include inadequate patent protection, challenges to validity, competitor circumvention, costly patent litigation, and potential injunctions against product sales - The company's success relies on protecting proprietary technology through patents and IP rights, which may not sufficiently prevent competition[110](index=110&type=chunk) - The medical device industry is prone to extensive patent litigation, potentially leading to high costs, significant damages, and sales injunctions for Sensus[114](index=114&type=chunk) [Risks Related to the Ownership of Sensus's Securities](index=22&type=section&id=Risks%20Related%20to%20the%20Ownership%20of%20Sensus%27s%20Securities) Securities ownership risks include a history of net losses, uncertain future profitability, limited trading volume, no anticipated dividends, substantial influence from executive officers, and anti-takeover provisions - The company had net losses through 2020, and despite 2021 net income, maintaining profitability is not assured[116](index=116&type=chunk) - The company does not anticipate paying dividends, requiring investors to rely on stock price appreciation for returns[118](index=118&type=chunk) - As of March 9, 2022, executive officers and directors beneficially owned approximately **17%** of common stock, exerting substantial influence[126](index=126&type=chunk) - Anti-takeover provisions in the company's charter and bylaws may discourage or prevent favorable mergers or acquisitions[128](index=128&type=chunk) [Properties](index=26&type=section&id=Item%202.%20Properties) Sensus's corporate headquarters is a leased **8,926 sq. ft.** facility in Boca Raton, Florida, with manufacturing outsourced - The company's corporate headquarters is a leased **8,926 sq. ft.** facility in Boca Raton, Florida, with the lease expiring in September 2022[133](index=133&type=chunk) [Legal Proceedings](index=26&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in ordinary course legal proceedings but does not anticipate a material effect on its financial position or operations - Sensus is involved in ordinary course legal proceedings but does not expect a material impact on its financial condition[134](index=134&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=27&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Sensus Healthcare's common stock trades on NASDAQ under 'SRTS'; no dividends are anticipated due to business needs and credit facility restrictions - The company's common stock trades on the NASDAQ Capital Market under the symbol **'SRTS'**[137](index=137&type=chunk) - Sensus has never paid dividends and anticipates retaining all future earnings for business use, with payments also restricted by its revolving line of credit[138](index=138&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2021, Sensus achieved profitability with revenues surging **182%** to **$27.0 million**, resulting in **$4.1 million** net income, a significant turnaround [Results of Operations](index=29&type=section&id=Results%20of%20Operations) In 2021, revenues surged **182%** to **$27.0 million** from **$9.6 million** in 2020, driving gross profit to **$17.0 million** and resulting in **$4.1 million** income from operations Consolidated Statements of Operations (in thousands) | | 2021 | 2020 | | :--- | :--- | :--- | | **Revenues** | **$27,042** | **$9,577** | | Cost of sales | $10,054 | $4,328 | | **Gross profit** | **$16,988** | **$5,249** | | Selling and marketing | $4,838 | $5,336 | | General and administrative | $4,594 | $3,989 | | Research and development | $3,436 | $4,158 | | **Total operating expenses** | **$12,868** | **$13,483** | | **Income (loss) from operations** | **$4,120** | **($8,234)** | | Other income (expense), net | ($1) | $1,398 | | **Net income (loss)** | **$4,119** | **($6,836)** | - Revenues in 2021 increased by **$17.5 million**, or **182%**, from 2020, reflecting a strong recovery in units sold as COVID-19 restrictions eased[148](index=148&type=chunk) - Research and development expenses decreased by **$0.7 million** (**17.4%**) from 2020, primarily due to lower spending as the Sculptura project entered production[150](index=150&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and cash equivalents were **$14.5 million** at year-end 2021, a slight decrease from **$14.9 million** in 2020, with no outstanding borrowings on the **$10 million** revolving credit facility Summary of Cash Flows (in thousands) | | For the Year Ended Dec 31, 2021 | For the Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash provided by (used in): | | | | Operating activities | $(286) | $(434) | | Investing activities | $129 | $7,030 | | Financing activities | $(231) | $211 | | **Increase (decrease) in cash** | **$(388)** | **$6,807** | - The company's cash and cash equivalent balance decreased slightly to **$14.5 million** at year-end 2021 from **$14.9 million** at year-end 2020[152](index=152&type=chunk) - In 2020, the company received a PPP loan of **$1,022,785**, with **$757,782** forgiven and a remaining balance of **$51,021** by year-end 2021[154](index=154&type=chunk) [Financial Statements and Supplementary Data](index=32&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements for 2021 and 2020, with an unqualified auditor's opinion and detailed notes [Note 1 — Organization and Summary of Significant Accounting Policies](index=38&type=section&id=Note%201%20%E2%80%94%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) Sensus manufactures and sells radiation therapy devices globally; 2021 revenue included **$22.2 million** product and **$4.8 million** service, with high U.S. and customer concentration Disaggregated Revenue (in thousands) | | 2021 | 2020 | | :--- | :--- | :--- | | Product revenue | $22,217 | $5,449 | | Service revenue | $4,825 | $4,128 | | **Total revenue** | **$27,042** | **$9,577** | - The company has significant credit risk and revenue concentration, with **95% of 2021 revenue from the U.S.** and one U.S. customer accounting for approximately **57% of revenue** and **94% of accounts receivable**[198](index=198&type=chunk) [Note 2 — ACQUISITIONS](index=43&type=section&id=Note%202%20%E2%80%94%20ACQUISITIONS) The August 2020 acquisition of two mobile aesthetic laser companies resulted in a **$588,000** bargain purchase gain, but a 2021 asset sale led to an **$88,000** impairment and **$47,000** loss - The August 2020 acquisition of two mobile aesthetic laser companies resulted in a bargain purchase gain of **$588,000** in 2020[220](index=220&type=chunk) - In 2021, an asset sale back to an acquired party resulted in an **$88,000** impairment charge on intangible assets and a **$47,000** loss on property and equipment sale[222](index=222&type=chunk) [Note 5 — DEBT](index=44&type=section&id=Note%205%20%E2%80%94%20DEBT) Sensus has a **$10 million** revolving credit facility, unused as of year-end 2021 and 2020, and a 2020 PPP loan of **$1,022,785** had **$757,782** forgiven, with **$51,000** remaining - The company maintains a revolving credit facility with a **$10 million** commitment, unused as of December 31, 2021 and 2020[227](index=227&type=chunk) - The company received a PPP loan of **$1,022,785** in April 2020, with **$757,782** forgiven and a remaining balance of **$51,000** at year-end 2021[228](index=228&type=chunk) [Note 11 — Subsequent Events](index=50&type=section&id=Note%2011%20%E2%80%94%20Subsequent%20Events) On February 25, 2022, Sensus sold its Sculptura product assets for **$15 million** in cash, with a net book value of approximately **$1.6 million** - On February 25, 2022, the company sold its Sculptura product assets for **$15 million** in cash, with a net book value of approximately **$1.6 million**[259](index=259&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2021 - Management concluded that as of December 31, 2021, the company's disclosure controls and procedures and internal control over financial reporting were effective[262](index=262&type=chunk)[263](index=263&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=52&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2022 Annual Meeting Proxy Statement - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the 2022 Annual Meeting Proxy Statement[270](index=270&type=chunk) [Executive Compensation](index=52&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive compensation is incorporated by reference from the company's Proxy Statement for its 2022 Annual Meeting - Information regarding executive compensation is incorporated by reference from the 2022 Annual Meeting Proxy Statement[271](index=271&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=52&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details equity compensation plans, with **229,334** securities issuable upon exercise at a weighted-average price of **$5.55**, and **135,973** securities remaining for future issuance Equity Compensation Plan Information | Plan Category | Securities to be issued upon exercise (a) | Weighted-average exercise price (b) | Securities remaining available for future issuance (c) | | :--- | :--- | :--- | :--- | | Equity Compensation Plans Approved by Securities Holders | 229,334 | $5.55 | 135,973 | | Total | 229,334 | $5.55 | 135,973 | [Certain Relationships and Related Transactions, and Director Independence](index=52&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2022 Annual Meeting Proxy Statement - Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the 2022 Annual Meeting Proxy Statement[274](index=274&type=chunk) [Principal Accountant Fees and Services](index=52&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information on principal accountant fees and services is incorporated by reference from the company's Proxy Statement for its 2022 Annual Meeting - Information regarding principal accountant fees and services is incorporated by reference from the 2022 Annual Meeting Proxy Statement[275](index=275&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=53&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all documents filed as part of the Form 10-K report, including consolidated financial statements and an index of exhibits required by Regulation S-K - This section contains the list of financial statements and all exhibits filed with the annual report, including material agreements and certifications[278](index=278&type=chunk)