Product Development and Innovation - The company has introduced two new product platforms in 2023, Define and Envision, expanding its offerings to a total of 12 product platforms[32]. - The company launched two new products, Define and Envision, in 2023, expanding its portfolio of innovative, energy-based, minimally invasive surgical medical treatment solutions[180]. - Since 2010, the company has launched 12 product platforms, demonstrating a strong track record of sustained new and next-generation product development[180]. - The company is developing additional RF energy-based platforms and applicators targeted towards several medical specialties to enhance its offerings[183]. - The proprietary Simultaneous Fat Destruction and Skin Tightening technology is claimed to be the first RF-based, non-invasive body contouring technology that permanently kills adipose tissue[194]. - The Triton product for permanent hair reduction is noted as the only FDA-cleared, single-pulse, dual wavelength product in the market[198]. - The BodyTite handpiece, introduced in 2010, utilizes directional RF energy for minimally invasive treatments, allowing treatment depth up to 50mm[211]. - The Morpheus8 handpiece, launched in 2021, offers programmable RF energy for subdermal adipose tissue remodeling with treatment depth up to 7mm[215]. - The company intends to leverage its existing technology to develop new minimally and non-invasive applications targeting various medical conditions[205]. Market Strategy and Customer Base - The company aims to expand its customer base beyond traditional markets, targeting non-traditional customers such as ENTs and general practitioners[34]. - The company is in the early stages of developing new platforms for ENT and urology, focusing on treatments for snoring and erectile dysfunction, respectively[188]. - The company plans to expand its direct sales presence in the United States and Canada, and establish sales organizations in Europe and Latin America[203]. - The company aims to satisfy unmet market demand by targeting patients who are averse to surgical procedures due to costs, downtime, and safety risks[179]. - The company offers extensive post-sales support, including training and marketing assistance, to enhance the utilization of its products by physicians[199]. Financial Performance - Revenue for the year ended December 31, 2023, increased to approximately $492.0 million, up from $454.3 million in 2022, representing a growth of 8.5% year-over-year[186]. - Gross margin for 2023 remained stable at approximately 84%, compared to 84% in 2022 and 85% in 2021[186]. - Net income for 2023 was approximately $197.9 million, an increase from $161.5 million in 2022, reflecting a growth of 22.5%[186]. - U.S. revenue for 2023 was approximately $307.8 million, up from $298.6 million in 2022, with minimally invasive platforms contributing approximately $264.7 million, or 86% of total U.S. revenue[187]. - International sales accounted for approximately 37% of total revenue for the year ended December 31, 2023[60]. Regulatory Compliance and Risks - The company is subject to extensive regulatory compliance obligations, and failure to meet these could adversely affect its operations[31]. - Regulatory compliance is critical, as failure to obtain necessary FDA clearances could harm commercial operations[116]. - The FDA's 510(k) clearance process typically takes 3 to 12 months, while premarket approval can take 1 to 3 years or longer, impacting product launch timelines[118]. - The company must ensure that promotional materials comply with FDA regulations to avoid penalties and reputational damage[127]. - The company faces increased scrutiny from regulatory authorities as it grows, which may lead to higher compliance costs and potential legal liabilities[84]. - The company may face significant costs in obtaining and maintaining international regulatory approvals for its products[138]. - The company is subject to evolving healthcare laws and regulations, which could materially affect its business operations and result in significant penalties if not complied with[92]. Competitive Landscape - The competitive landscape in the medical aesthetics market is characterized by rapid innovation, necessitating ongoing product development to maintain market position[49]. - The company faces intense competition from both public and private companies, which could impact market share and profit margins[51]. - The company acknowledges that competitors may exploit jurisdictions where it lacks patent protection, potentially harming its competitive position[98]. Supply Chain and Operational Risks - The company faces significant risks including market acceptance of its products, reliance on a limited number of suppliers, and potential product liability suits[31]. - There is a risk of supply shortages and price fluctuations due to reliance on a limited number of suppliers for components[68]. - The company outsources almost all manufacturing to subcontractors, which may lead to delivery delays if operations are interrupted[65]. - The company’s financial results may fluctuate due to reliance on anticipated orders and a limited number of contract manufacturers, which increases operational risks[47]. Economic and Geopolitical Factors - The ongoing Israel-Hamas conflict could disrupt operations and delay shipments, adversely affecting business and financial results[62]. - Political, economic, and military conditions in Israel, including the recent Israel-Hamas conflict, could directly affect the company's business operations[157]. - Global economic conditions, including the ongoing war in Ukraine and rising interest rates, may adversely affect customer purchasing power and demand for aesthetic procedures[78]. - The intensity and duration of the current war against Hamas are unpredictable, which may have significant economic implications for the company and Israel's economy[160]. Intellectual Property and Litigation - The company has issued 10 U.S. patents and one Korean patent, with seven pending patent applications in the U.S., indicating a focus on protecting its proprietary technology[99]. - The company’s ability to protect its intellectual property is critical for maintaining its competitive position in the market[97]. - The company may incur substantial costs related to litigation over intellectual property rights, which could adversely affect its financial condition and operational capabilities[106]. - The company may indemnify customers and distributors against claims related to third-party intellectual property rights, which could lead to costly litigation[110]. - There is a risk of compromising confidential information during intellectual property litigation, potentially affecting the company's share price[111]. Cybersecurity and Data Protection - Cyber-attacks and data breaches could result in significant liabilities and harm the company's reputation, impacting financial performance[82]. - Compliance with evolving data protection laws, such as GDPR, could impose additional costs and operational challenges for the company[86]. - The invalidation of the EU-US Privacy Shield Framework may complicate personal data transfers, leading to potential regulatory investigations and fines[87]. - The company may incur substantial liabilities if customer confidential information is misappropriated or disclosed due to security breaches[90]. Management and Corporate Governance - The management team has an average of over 15 years of experience in the medical aesthetics industry, with a proven track record in developing innovative technologies[203]. - The company is a "foreign private issuer," which allows it to follow home country corporate governance practices, potentially resulting in less investor protection compared to U.S. domestic issuers[156]. - The company may face increased regulatory and compliance costs if it loses its foreign private issuer status, requiring more detailed reporting and governance practices[155].

Revenue Performance - Fourth quarter 2023 revenue was $126.8 million, a decrease of 5.4% from $133.6 million in Q4 2022[6] - Full year 2023 revenue reached a record $492 million, representing an 8% year-over-year increase from $454.3 million in 2022[6] - Revenues for Q4 2023 were $126,781,000, a decrease of 5.9% compared to $133,571,000 in Q4 2022[36] - For the full year 2023, revenues reached $492,048,000, an increase of 8.3% from $454,271,000 in 2022[39] - International revenues increased by 18% year-over-year, contributing to overall revenue growth[6] Profitability - GAAP net income for Q4 2023 was $55.2 million, or $0.64 per diluted share, compared to $37.7 million, or $0.44 per diluted share in Q4 2022[10] - Non-GAAP net income for Q4 2023 was $61.5 million, or $0.71 per diluted share, down from $66.4 million, or $0.78 per diluted share in Q4 2022[10] - Net income for Q4 2023 increased to $55,165 thousand, a 46.3% rise from $37,708 thousand in Q4 2022[26] - Net income for Q4 2023 was $61,487,000, compared to $66,370,000 in Q4 2022, representing a decrease of 7.4%[36] - Net income for the year 2023 was $221,519,000, compared to $207,486,000 in 2022, reflecting an increase of 6.8%[39] Gross Margin - Gross margins for both GAAP and non-GAAP were 84% for Q4 2023, consistent with the previous year[8] - Gross profit for the year ended December 31, 2023, was $411,340 thousand, up 8.0% from $380,786 thousand in 2022[26] - Gross profit for Q4 2023 was $107,090,000, down from $113,122,000 in Q4 2022, reflecting a decline of 5.3%[36] - Gross profit for the year ended December 31, 2023, was $413,386,000, up from $382,703,000 in 2022, indicating an increase of 8.0%[39] - Non-GAAP gross margin for 2024 is projected to be between 83% and 85%[14] Operating Expenses - Operating expenses for the year increased to $215,680 thousand, up 17.9% from $182,932 thousand in 2022, primarily driven by sales and marketing expenses[26] - Operating expenses totaled $49,524,000 in Q4 2023, an increase of 7.5% from $46,076,000 in Q4 2022[36] - Operating expenses for the year were $194,126,000, a rise of 20.9% compared to $160,397,000 in 2022[39] Cash Position and Assets - As of December 31, 2023, the total cash position was $741.6 million, including cash and cash equivalents, marketable securities, and short-term bank deposits[11] - Cash and cash equivalents at the end of Q4 2023 were $144,411 thousand, compared to $97,540 thousand at the end of Q4 2022, reflecting a 47.9% increase[31] - Total assets as of December 31, 2023, were $863,286 thousand, up 34.1% from $644,409 thousand in 2022[28] - Total liabilities decreased to $75,914 thousand as of December 31, 2023, down from $89,791 thousand in 2022, a reduction of 15.5%[28] Future Outlook - The company plans to launch 2 new platforms in 2024 to enhance market share in minimally invasive aesthetics treatments[5] - Management expects 2024 revenue to be between $495 million and $505 million[14] - The company plans to continue investing in research and development, with R&D expenses for the year totaling $13,410 thousand, an increase from $12,425 thousand in 2022[26]

Financial Performance - Quarterly revenue of $123.1 million, representing a 2% year-over-year growth compared to $121.2 million in Q3 2022[5] - GAAP net income of $46.5 million, down from $48.8 million in Q3 2022, with diluted earnings per share of $0.54 compared to $0.58[10] - Non-GAAP net income of $53.1 million, compared to $56.6 million in Q3 2022, with non-GAAP diluted earnings per share of $0.61 versus $0.66[10] - Total net revenue for the three months ended September 30, 2023, was $123.11 million, a slight increase of 1.5% from $121.23 million in the same period of 2022[32] - Net income for the three months ended September 30, 2023, was $46.52 million, a decrease of 4.6% compared to $48.79 million in the same period of 2022[30] - Revenues for the nine months ended September 30, 2023, increased to $365.267 million, up from $320.700 million in the same period of 2022, representing a growth of 13.9%[37] - Net income for the nine months ended September 30, 2023, reached $160.032 million, up from $141.116 million in 2022, indicating an increase of 13.4%[37] - Basic net income per share for the nine months ended September 30, 2023, was $1.71, compared to $1.50 in 2022, reflecting a growth of 14.0%[37] - Diluted net income per share for the nine months ended September 30, 2023, was $1.66, up from $1.45 in 2022, representing an increase of 14.5%[37] Revenue Breakdown - Revenues from consumables and services increased by 28% year-over-year, totaling $17.9 million[5] - Capital equipment revenues in the United States for the three months ended September 30, 2023, were $67.97 million, accounting for 55% of total revenues, compared to 60% in the same period of 2022[32] - Consumables and service revenues increased to $17.87 million, representing 15% of total revenues, compared to 12% in the same period of 2022[32] Margins and Expenses - Gross margins for Q3 2023 were 84%, a slight decrease from 85% in Q3 2022[8] - Total operating expenses rose to $144.602 million for the nine months ended September 30, 2023, from $114.321 million in 2022, marking an increase of 26.5%[37] - Research and development expenses for the nine months ended September 30, 2023, were $7.950 million, slightly down from $6.916 million in 2022, indicating a focus on cost management[37] - Sales and marketing expenses increased to $131.035 million for the nine months ended September 30, 2023, from $101.331 million in 2022, a rise of 29.3%[37] Cash and Assets - Total cash position as of September 30, 2023, was $675.8 million, including cash and cash equivalents, marketable securities, and short-term bank deposits[5] - Cash and cash equivalents at the end of the period were $133.73 million, up from $97.54 million at the beginning of the period[30] - Total assets increased to $793.53 million in September 2023, up from $644.41 million in December 2022, representing a growth of 23.2%[27] - Total current liabilities decreased to $62.19 million in September 2023, down from $82.02 million in December 2022, a reduction of 24.2%[27] - Total shareholders' equity increased to $723.50 million in September 2023, up from $554.62 million in December 2022, reflecting a growth of 30.5%[27] Future Outlook - Management expects full-year 2023 revenue to be between $500 million and $510 million, with non-GAAP gross margin projected between 83% and 85%[14] - The soft launch of the Envision platform is gaining traction among ophthalmologists and optometrists in the U.S.[6] - The company is developing new minimally invasive technologies and upgrading existing platforms like Morpheus8 and Evolve[6] Shareholder Information - The company reported a basic net income per share of $0.56 for the three months ended September 30, 2023, compared to $0.59 in the same period of 2022[34] - The weighted average number of diluted shares outstanding increased to 86,154 thousand for the nine months ended September 30, 2023, compared to 85,667 thousand in 2022[37]

Financial Data and Key Metrics Changes - InMode reported record revenue of $136.1 million for Q2 2023, a 20% increase compared to Q2 2022 [3][13] - Gross margin was 84% on a GAAP basis, with GAAP operating margin at 42%, slightly down from 43% in Q2 2022 [17] - Non-GAAP diluted earnings per share reached a record $0.72, compared to $0.59 in Q2 2022 [17] - The company ended the quarter with cash and cash equivalents of $629.4 million [17] Business Line Data and Key Metrics Changes - Revenue from consumables and services grew nearly 44% year-over-year, indicating increased usage of platforms [11] - Capital equipment sales represented 84% of total revenue, while consumables and service revenues accounted for 16% [14] - Sales outside the US reached $49.5 million, up from $41.2 million in Q2 2022 [13] Market Data and Key Metrics Changes - InMode established two new subsidiaries in Japan and Germany to enhance direct sales capabilities [8] - Sales from Asia hit a new record, contributing to overall growth [13] - The company operates in 92 countries with over 264 direct sales representatives and 81 distributors [14] Company Strategy and Development Direction - InMode plans to invest heavily in product development, launching new technologies and platforms over the next 12 months [4] - The company aims to secure additional FDA indications, with eight studies currently in process [10] - InMode's strategy includes direct sales in markets where it previously relied on distributors, enhancing market presence and revenue recognition [67] Management's Comments on Operating Environment and Future Outlook - Management noted strong demand for consumables, with expectations for continued growth despite seasonal trends [25] - The competitive landscape remains challenging, but InMode's brand awareness and innovation are seen as advantages [50] - Management expressed confidence in the sustainability of growth, particularly in the ophthalmology market [12] Other Important Information - InMode became part of the Russell 2000 Index, enhancing its visibility among investors [10] - The company is focused on maintaining a strong balance sheet while exploring M&A opportunities [101] Q&A Session Summary Question: Sustainability of consumables demand amid macroeconomic headwinds - Management indicated strong demand continues into July, with expectations for Q3 and Q4 to be higher than current levels [25] Question: Trends in capital equipment demand and financing - Management noted that while financing conditions have tightened, demand remains strong, and they are adapting to the environment [28][30] Question: Seasonal cadence for system sales in the back half of the year - Management acknowledged typical seasonality but noted that demand in North America remains strong [42][44] Question: Competitive environment and market dynamics - Management stated that competition is strong, but their focus on brand awareness and innovation helps maintain their market position [50] Question: Updates on Empower platform and hiring - Management confirmed growth in Empower sales and ongoing discussions with the FDA regarding new indications [54] Question: Capital allocation priorities and potential M&A - Management is open to acquiring more IP and exploring M&A opportunities, but no immediate deals are confirmed [101] Question: Leasing dynamics and technology upgrades for customers - Management reported that leasing remains stable, and they provide upgrades for software at no cost when possible [104]

Financial Performance - Record quarterly revenue of $136.1 million, representing a 20% year-over-year growth compared to Q2 2022[5] - Total net revenue for Q2 2023 reached $136.1 million, a 20% increase from $113.5 million in Q2 2022[29] - Revenues for the six months ended June 30, 2023, increased to $242,155,000, up from $199,468,000 in the same period of 2022, representing a growth of 21.4%[33] - Net income for Q2 2023 was $55.7 million, up 26% from $44.0 million in Q2 2022[31] - Net income for the six months ended June 30, 2023, was $106,948,000, compared to $84,470,000 in 2022, which is an increase of 26.7%[33] - Basic net income per share increased to $1.28 for the first half of 2023, up from $1.02 in the same period of 2022, representing a growth of 25.5%[33] - Diluted net income per share rose to $1.24 in the first half of 2023, compared to $0.98 in 2022, reflecting a year-over-year increase of 26.5%[33] Profitability Metrics - GAAP net income reached $55.7 million, up from $44.0 million in Q2 2022; non-GAAP net income was $62.2 million, compared to $50.4 million in Q2 2022[9] - GAAP diluted earnings per share of $0.65, an increase from $0.52 in Q2 2022; non-GAAP diluted earnings per share of $0.72, up from $0.59 in Q2 2022[5] - GAAP gross margin for Q2 2023 was 84%, compared to 83% in Q2 2022; non-GAAP gross margin remained at 84%[7] - The company reported a gross profit of $114.0 million for Q2 2023, representing a gross margin of 84%[31] - Gross profit for the first half of 2023 was $202,748,000, compared to $166,560,000 in 2022, reflecting a year-over-year increase of 21.7%[33] Cash and Assets - Total cash position as of June 30, 2023, was $629.4 million, including cash and cash equivalents, marketable securities, and short-term bank deposits[5] - Cash and cash equivalents increased to $159.9 million as of June 30, 2023, compared to $97.5 million at the end of June 2022[27] - Total current assets rose to $719.2 million, a 14% increase from $629.4 million in the previous year[24] Expenses and Liabilities - Operating expenses totaled $94,028,000 for the six months ended June 30, 2023, compared to $72,902,000 in 2022, marking an increase of 28.9%[33] - Research and development expenses for Q2 2023 were $3.6 million, slightly up from $3.2 million in Q2 2022[31] - Research and development expenses were $5,411,000 for the first half of 2023, compared to $4,607,000 in 2022, an increase of 17.4%[33] - Sales and marketing expenses increased to $85,003,000 in the first half of 2023, up from $64,148,000 in 2022, representing a growth of 32.5%[33] - Total liabilities decreased to $67.9 million, down 24% from $89.8 million in June 2022[24] Future Outlook - Management expects full-year 2023 revenue to be between $530 million and $540 million[13] - Non-GAAP earnings per diluted share guidance for 2023 is projected to be between $2.62 and $2.66[13] - The company plans to continue expanding its market presence and investing in new technologies to drive future growth[31] Sales Growth - Revenue from consumables and services grew nearly 44% year-over-year, reaching a record level of $21.6 million[4] - Significant international sales growth reached a record level of $49.5 million in Q2 2023[7] - Capital equipment revenues in the U.S. grew by 17% to $73.8 million, while international revenues increased by 14% to $40.6 million[29] Operating Performance - GAAP operating margin for Q2 2023 was 42%, slightly down from 43% in Q2 2022; non-GAAP operating margin was 47%, compared to 49% in Q2 2022[8] - Operating cash flow for Q2 2023 was $53.0 million, compared to $47.0 million in Q2 2022[27] - Income from operations rose to $108,720,000 in the first half of 2023, up from $93,658,000 in 2022, indicating a growth of 16.0%[33]

Revenue and Growth - Quarterly revenue of $106.1 million, representing a 23.5% year-over-year growth[2][6] - Total net revenue grew to $106,074 thousand in Q1 2023, a 23.5% increase compared to $85,921 thousand in Q1 2022[30] - Record quarterly revenues from consumables and service of $20 million, a 43% increase compared to the first quarter of 2022[6] - Capital Equipment revenues in the United States reached $49,751 thousand, accounting for 47% of total revenue in Q1 2023, up from $44,760 thousand (52%) in Q1 2022[30] - International Capital Equipment revenues increased to $36,373 thousand (34% of total revenue) in Q1 2023, compared to $27,183 thousand (32%) in Q1 2022[30] - Consumables and service revenues grew to $19,950 thousand (19% of total revenue) in Q1 2023, up from $13,978 thousand (16%) in Q1 2022[30] - Minimally Invasive technology accounted for 83% of total revenues by technology in Q1 2023, compared to 80% in Q1 2022[30] Net Income and Profitability - GAAP net income of $40.5 million, compared to $31 million in the first quarter of 2022[6][11] - Non-GAAP net income of $44.7 million, compared to $34.1 million in the first quarter of 2022[6][11] - Net income increased to $40,505 thousand in Q1 2023, up from $30,975 thousand in Q1 2022, representing a 30.8% year-over-year growth[28] - Non-GAAP net income was $44,714 thousand in Q1 2023, compared to $34,069 thousand in Q1 2022, representing a 31.2% increase[33] Gross and Operating Margins - GAAP gross margin for the first quarter of 2023 and 2022 was 83%[9] - Non-GAAP gross margin for the first quarter of 2023 and 2022 was 83%[9] - GAAP operating margin for the first quarter of 2023 was 39%, compared to 41% in the first quarter of 2022[10] - Non-GAAP operating margin for the first quarter of 2023 was 43%, compared to 44% in the first quarter of 2022[10] Cash Position and Cash Flow - Total cash position of $574.5 million as of March 31, 2023[6] - Net cash provided by operating activities decreased to $21,113 thousand in Q1 2023, down from $31,853 thousand in Q1 2022[28] - Net cash used in investing activities increased to $27,556 thousand in Q1 2023, compared to $12,692 thousand in Q1 2022[28] - Cash and cash equivalents at the end of Q1 2023 stood at $92,961 thousand, up from $44,670 thousand at the end of Q1 2022[28] Financial Outlook - 2023 financial outlook: revenue between $525 million and $530 million, non-GAAP gross margin between 83% and 85%, non-GAAP income from operations between $236 million and $238 million, non-GAAP earnings per diluted share between $2.58 and $2.60[15]

Revenue and Financial Performance - Revenue from minimally invasive platforms grew by $112.7 million (44%) in 2022 compared to 2021, contributing 81% of total revenue[362] - Revenue from hands-free platforms decreased by $27.3 million (38%) in 2022, contributing 10% of total revenue[362] - Revenue from non-invasive platforms grew by $11.3 million (39%) in 2022, contributing 9% of total revenue[362] - Total revenue for 2022 was $454.3 million, a 27% increase from $357.6 million in 2021[397] - Gross profit for 2022 was $380.8 million (84% of revenue), compared to $304.0 million (85% of revenue) in 2021[397] - Net income for 2022 was $161.5 million (36% of revenue), compared to $165.1 million (46% of revenue) in 2021[397] - Income taxes increased significantly to $39.9 million (9% of revenue) in 2022 from $2.9 million (1% of revenue) in 2021[397] - Revenues increased by $96.7 million (27%) to $454.3 million in 2022, driven by a $112.7 million increase in minimal invasive platform sales, offset by a $27.3 million decrease in hand-free platform sales[398] - U.S. revenues grew by $61.3 million (26%) to $298.6 million in 2022, primarily due to an $85.4 million increase in minimal invasive platform sales and growth in consumable sales[399] - International revenues increased by $35.4 million (29%) to $155.7 million in 2022, driven by growth in Europe ($12.7 million), Canada ($9.6 million), and Latin America ($5.1 million)[400] - Consumables and extended warranty revenues grew by 57% in 2022, supported by a 5,400-unit increase in installed platform base[401] - Gross margin decreased to 84% in 2022 from 85% in 2021, primarily due to higher material costs[402] - Net cash provided by operating activities was $181.6 million in 2022, driven by a net profit of $161.5 million[413] Expenses and Investments - Research and development expenses increased to $12.4 million (3% of revenue) in 2022 from $9.5 million (3% of revenue) in 2021[397] - Sales and marketing expenses increased to $160.6 million (35% of revenue) in 2022 from $119.4 million (33% of revenue) in 2021[397] - Research and development expenses increased to $12.4 million in 2022, up from $9.5 million in 2021, driven by higher salary and share-based compensation[403] - Sales and marketing expenses rose by $41.2 million (35%) to $160.6 million in 2022, primarily due to increased salary and marketing costs[404] Market and Product Performance - Global installed base of approximately 17,000 product platforms as of December 31, 2022[359] - InMode's product platforms include BodyTite, Optimas, Votiva, Contoura, Triton, EmbraceRF, EvolveX, Evoke, Morpheus8, and EmpowerRF, with EmpowerRF and EvolveX introduced in 2021[32] - The InMode RF Multi-System with Fractional Applicators employs RF energy for dermatological and general surgical procedures, including skin ablation, resurfacing, and hemostasis[297] - InMode's EmFace (Evoke) device with Cheek and Chin applicators is FDA-cleared for temporary relief of minor muscle aches, pain, and improvement of local blood circulation[299] - InMode's EmBody (Evolve) platform with EmBodyPlus and EmBodyFX applicators is FDA-cleared for temporary relief of muscle aches, pain, and reduction in the appearance of cellulite[299] Regulatory and Compliance - InMode must obtain and maintain FDA clearances for its products to avoid harm to commercial operations[33] - The company's products are subject to extensive regulatory compliance, including FDA requirements for modifications, which may necessitate new 510(k) clearances or PMA applications[291] - InMode's products are subject to FDA regulations, including 510(k) clearance, labeling, advertising, and post-market surveillance requirements[313] - The company is subject to FDA inspections to ensure compliance with Quality System Regulations (QSR) and other regulatory requirements[310] - FDA clearance process for new medical devices typically takes 3 to 12 months, with premarket approval potentially taking 1 to 3 years or longer[122] - FDA may revoke 510(k) clearances, requiring changes to promotional materials or cessation of marketing for certain devices[123] - Modifications to existing devices may require new FDA clearances, potentially leading to recalls or marketing halts[124] - FDA's potential modernization of the 510(k) pathway could impose additional regulatory requirements, increasing costs and delaying new clearances[125] - Regulatory compliance failures could result in fines, product recalls, or shutdowns of production facilities[138] - Regulatory clearances or approvals for products can be withdrawn due to non-compliance or unforeseen issues, potentially leading to fines, recalls, or criminal sanctions[126] - Misuse or off-label use of products may harm the company's reputation, lead to product liability suits, or result in costly investigations and fines[127] - Most of the company's products are classified as Class I or Class II medical devices, exempt from premarketing authorization or subject to the 510(k) clearance process[128] - The FDA may enforce actions if promotional materials are deemed to promote off-label uses, potentially leading to fines, seizures, or criminal penalties[129] - Physicians' off-label use of products may increase the risk of injury, harm the company's reputation, and lead to costly product liability claims[130] - Failure to comply with post-marketing regulatory requirements could result in enforcement actions, including penalties, recalls, or product withdrawals[131] - Non-compliance with FDA's Quality System Regulation (QSR) or laser performance standards could halt manufacturing operations and harm the business[134] - Adverse medical events or product malfunctions must be reported to the FDA, and failure to do so could result in sanctions, including fines or product seizures[136] Intellectual Property and Legal Risks - The company's success depends on protecting its proprietary technology and intellectual property rights[33] - The company's patent portfolio is subject to uncertainty, with potential risks including invalidation, unenforceability, or limitations in scope, which could adversely affect its business[265] - The company's intellectual property strategy relies on patents, trademarks, and confidentiality agreements, but these measures may not fully prevent unauthorized disclosure or infringement[105] - The company may face litigation or licensing challenges from third parties claiming patent infringement, which could result in substantial damages or product redesigns[106] - The company's intellectual property rights may not provide complete protection against competitors, as third parties could develop technologies outside its patent scope[103] - The company's patent portfolio includes 6 issued U.S. patents, 1 issued Korean patent, and 14 pending U.S. patent applications, with additional filings under the Patent Cooperation Treaty and in Europe[103] - The company generates most of its revenue from the U.S., where it has patent protection, with no significant revenue from countries where patent protection is not sought[102] - The company faces risks from competitors potentially replicating its technology in jurisdictions without patent protection, which could harm its competitive position[102] - The company's trademarks and trade names are critical for market recognition, but they may face challenges, infringement, or genericization, impacting its competitive position[116] - The company may need to participate in costly legal proceedings, such as interference or opposition cases, to defend its patent rights against competitors[110] - Settled patent infringement claims with Syneron-Candela and MGH in January 2019, involving a one-time cash payment and a non-exclusive, royalty-free sublicense agreement[111] - Potential future litigation risks related to intellectual property infringement, which could result in substantial monetary liability, product redesign, or loss of intellectual property rights[109][111] - Risks of litigation related to trademark disputes, which could lead to brand name changes, customer confusion, and reduced sales[112] - Potential for confidential information disclosure during intellectual property litigation, which could adversely affect the company's stock price[115] Market Expansion and Strategy - The company's ability to increase revenues depends on identifying and penetrating new markets for its products[21] - The company aims to innovate, develop, and commercialize existing and new products beyond its traditional customer base[21] - InMode's commercialization, marketing, and manufacturing capabilities are key to its strategy[21] - The company's estimates of expenses, future revenue, and capital requirements are critical to its financial planning[21] - The company's international sales accounted for 34% of total revenues in both 2022 and 2021, with a focus on expanding into markets such as Canada, the UK, Spain, Portugal, France, Belgium, Luxembourg, Italy, Australia, and India[250] - The company's growth strategy includes expanding its customer base to non-traditional markets such as ENT physicians, ophthalmologists, general practitioners, and aesthetic clinicians[34] - The company's success depends on maintaining strong relationships with physicians and healthcare professionals, as well as attracting and retaining key personnel to drive product development and sales[37][45] - The company's financial results may fluctuate due to factors such as customer adoption, regulatory compliance, supply chain disruptions, and the impact of global health crises like COVID-19[48][49] - Regulatory risks in international markets, including delays, additional costs, and uncertainty in obtaining and maintaining foreign regulatory approvals[141] - Delays in obtaining international qualifications or approvals could prevent the company from effectively marketing products in certain global markets[142] Operational Risks and Challenges - InMode faces risks from rapid technological development and competition in the surgical aesthetic solutions market[33] - The company relies on a limited number of contract manufacturers and suppliers, with primary facilities located in Israel, making it vulnerable to disruptions such as natural disasters, epidemics, or COVID-19-related interruptions[49] - The company faces risks related to product liability claims, which could result in expensive litigation, damage awards, and increased insurance premiums, potentially impacting financial results[40] - The company's products are used in elective procedures, with demand influenced by factors such as patient affordability and economic conditions[35] - Exchange rate fluctuations may decrease earnings if currency exchange risks are not successfully hedged, with a majority of revenues and substantial expenses denominated in U.S. dollars, while some revenues and costs are incurred in NIS, Canadian dollars, and Euros[85] - Cyber-attacks and improper disclosure of personal information could result in liability, harm reputation, and adversely affect business and results of operations, with increasing frequency and sophistication of attacks[86] - The global data protection landscape is rapidly evolving, subjecting the company to numerous state, federal, and foreign laws, which may create uncertainty, affect operations, and impose additional costs[87] - The CCPA and CPRA in California increase compliance costs and potential liability, with the CPRA imposing additional data protection obligations and creating a new California data protection agency[89] - The GDPR imposes strict requirements for processing personal data within the EEA, with potential fines of up to €20 million or 4% of annual global revenues for non-compliance[90] - The UK GDPR mirrors the GDPR fines, with potential fines up to the greater of €20 million (£17.5 million) or 4% of global turnover, and uncertainty remains regarding data transfers between the UK and EU[91] - The CJEU invalidated the EU-US Privacy Shield Framework, requiring case-by-case assessment of standard contractual clauses for personal data transfers, potentially leading to additional costs and regulatory investigations[92][93] - Failure to comply with foreign, federal, and state healthcare statutes and regulations could result in significant civil, criminal, and administrative penalties, adversely affecting the company's ability to operate[97][98] - The company is subject to anti-bribery, corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act, with potential civil or criminal penalties for non-compliance[99][100] - Future sales of ordinary shares by shareholders could reduce the share price and impair the company's ability to raise capital or acquire other companies[148] Research and Development - InMode has 27 R&D staff based in Israel, focusing on developing new products and extending existing ones in the minimally and non-invasive medical aesthetic markets[260] - The company received three 510(k) FDA clearances for its Sub-Necrotic Thermal Tissue Remodeling technology in 2014, 2016, and 2017, with applications targeting fat and larger body areas at depths of up to 6mm[244] - The company outsources manufacturing to subcontractors who comply with ISO 13485:2016, CE, and FDA quality standards, with quality control employees stationed at subcontractor facilities[256] Share Repurchase and Capital Management - The company repurchased 2,557,829 shares for $95.2 million under its share repurchase programs as of December 31, 2022[409] - Working capital stood at $547.4 million as of December 31, 2022, with liquidity primarily from cash, cash equivalents, and marketable securities[410] - InMode Ltd. has 82,544,991 ordinary shares outstanding as of December 31, 2022[5] - The company repurchased 1,975,003 ordinary shares held as treasury shares by the end of 2022[11] Legal and Regulatory Compliance - As a foreign private issuer, InMode is exempt from certain U.S. securities laws and Nasdaq corporate governance rules[33] - The company is subject to U.S. federal and state data privacy laws, including HIPAA, CCPA, and CPRA, which regulate the handling of consumer and health information[88] - The company is subject to anti-bribery, corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act, with potential civil or criminal penalties for non-compliance[99][100]

Revenue Performance - Record quarterly revenue of $133.6 million, an increase of 21% year-over-year[7] - Full year 2022 revenues reached $454.3 million, representing a 27% increase compared to 2021[16] - Revenues for Q4 2022 reached $133,571,000, a 20.8% increase from $110,540,000 in Q4 2021[31] - Revenues for the three months ended December 31, 2022, were $133,571 thousand, an increase of 20.8% compared to $110,540 thousand for the same period in 2021[41] - For the year ended December 31, 2022, total revenues reached $454,271 thousand, a 27.1% increase from $357,565 thousand in 2021[44] Profitability Metrics - GAAP net income for Q4 2022 was $37.7 million, down from $52.7 million in Q4 2021; non-GAAP net income reached a record $66.4 million[15] - Net income for Q4 2022 was $37,708,000, compared to $52,685,000 in Q4 2021, indicating a decrease of 28.5%[31] - Net income for the three months ended December 31, 2022, was $66,370 thousand, a significant increase from $55,193 thousand in the prior year, marking a 20.2% growth[41] - Net income for the year ended December 31, 2022, was $207,486 thousand, compared to $176,420 thousand in 2021, showing an increase of 17.6%[44] Margins and Expenses - Gross margin for Q4 2022 was 84%, compared to 85% in Q4 2021; non-GAAP gross margin remained at 85%[13] - GAAP operating margin for 2022 was 44%, down from 47% in 2021; non-GAAP operating margin was 49%[17] - Gross profit for the year ended December 31, 2022, was $380,786,000, up from $303,973,000 in 2021, reflecting a 25.3% growth[31] - Operating expenses for the year ended December 31, 2022, totaled $182,932,000, compared to $136,496,000 in 2021, reflecting a 33.9% increase[31] - Operating expenses for the three months ended December 31, 2022, totaled $46,076 thousand, compared to $37,521 thousand in the same period of 2021, representing a 22.7% increase[41] - Operating expenses for the year ended December 31, 2022, were $160,397 thousand, up from $126,442 thousand in 2021, representing a 26.8% increase[44] Cash and Assets - Cash and cash equivalents as of December 31, 2022, totaled $547.4 million[19] - Cash and cash equivalents at the end of Q4 2022 were $97,540,000, up from $68,136,000 at the end of Q4 2021, a 43.2% increase[36] - Total current assets increased to $629,371,000 as of December 31, 2022, from $470,114,000 in 2021, representing a 33.8% growth[33] - Total liabilities increased to $89,791,000 as of December 31, 2022, from $62,739,000 in 2021, a 43.0% increase[33] Future Outlook - Management expects 2023 revenue between $525 million and $530 million, with non-GAAP earnings per diluted share projected between $2.58 and $2.60[22] - The Empower RF platform exceeded expectations, with ongoing clinical studies addressing various health issues for women[9] - InMode plans to launch the Envision platform for ophthalmology in the first half of 2023 and a second-generation hands-free platform later in the year[9] Research and Development - Research and development expenses for Q4 2022 were $3,261,000, up from $2,528,000 in Q4 2021, a 29.0% increase[31]

InMode Ltd. (NASDAQ:INMD) Q3 2022 Results Conference Call October 27, 2022 8:30 AM ET Company Participants Miri Segal - Investor Relations, MS-IR LLC Moshe Mizrahy - Chairman and Chief Executive Officer Michael Kreindel - Chief Technology Officer & Director Yair Malca - Chief Financial Officer Shakil Lakhani - President, North America Spero Theodorou - Chief Medical Officer Rafael Lickerman - VP of Finance Conference Call Participants Kyle Rose - Canaccord Genuity Matt Taylor - Jefferies Jeff Johnson - Bair ...

Exhibit 99.1 InMode Reports Third Quarter 2022 Financial Results; Record Quarterly Revenue of $121.2 M, Represents 29% Year-Over-Year Growth YOKNEAM, Israel, Oct. 27, 2022--InMode Ltd. (Nasdaq: INMD) ("InMode"), a leading global provider of innovative medical technologies, today announced its consolidated financial results for the third quarter ended September 30, 2022. Third Quarter 2022 Highlights: | U.S. GAAP Results | | | | --- | --- | --- | | (U.S. dollars in thousands, except for per share data) | | | ...