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]

Fourth Quarter 2022 Highlights: InMode Reports Fourth Quarter and Full Year 2022 Financial Results; Record Quarterly Revenue of $133.6M Represents 21% Year-Over-Year Growth YOKNEAM, Israel, Feb. 14, 2023- InMode Ltd. (Nasdaq: INMD) ("InMode"), a leading global provider of innovative medical technologies, today announced its consolidated financial results for the fourth quarter and full year ended December 31, 2022. Exhibit 99.1 ● 29% increase in international (non-U.S.) revenues as compared to 2021 *Please ...

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) | | | ...

InMode Ltd. (NASDAQ:INMD) Q2 2022 Earnings Conference Call July 28, 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 Q - Joseph Conway Q - Jeff Johnson Operator Good morning and welcome to the ...

Exhibit 99.1 InMode Reports Second Quarter 2022 Financial Results; Record Quarterly Revenue of $113.5M, Represents 30% Year-Over-Year Growth YOKNEAM, Israel, July 28, 2022--InMode Ltd. (Nasdaq: INMD) ("InMode"), a leading global provider of innovative medical technologies, today announced its consolidated financial results for the second quarter ended June 30, 2022. Second Quarter 2022 Highlights: | U.S. GAAP Results | | | | --- | --- | --- | | (U.S. dollars in thousands, except for per share data) | | | | ...

InMode Ltd. (NASDAQ:INMD) Q1 2022 Earnings Conference Call May 2, 2022 8:30 AM ET Company Participants Miri Segal - Investor Relations Moshe Mizrahy - Chairman and Chief Executive Officer Michael Kreindel - Co-Founder and Chief Technology Officer Yair Malca - Chief Financial Officer Shakil Lakhani - President, North America Spero Theodorou - Chief Medical Officer Rafael Lickerman - Vice President, Finance Conference Call Participants Mike Matson - Needham & Company Jeff Johnson - Baird Operator Hello and we ...

Exhibit 99.1 InMode Reports First Quarter 2022 Financial Results: Quarterly Revenue of $85.9M, GAAP Net Income of $31M Represent 31% and 16% Year-Over-Year Growth, Respectively YOKNEAM, Israel, May 2, 2022--InMode Ltd. (Nasdaq: INMD) ("InMode"), a leading global provider of innovative medical technologies, today announced its consolidated financial results for the first quarter ended March 31, 2022. First Quarter 2022 Highlights: | U.S. GAAP Results | | | | --- | --- | --- | | (U.S. dollars in thousands, ex ...

InMode Ltd. (NASDAQ:INMD) Q4 2021 Earnings Conference Call February 10, 2022 8:30 AM ET Company Participants Miri Segal - MS-IR Moshe Mizrahy - Chairman & CEO Shakil Lakhani - President, North America Yair Malca - CFO Spero Theodorou - CMO Conference Call Participants Matt Taylor - UBS Kyle Rose - Canaccord Genuity Michael Matson - Needham & Company Jeff Johnson - Robert W. Baird Operator Good day. Welcome to the InMode Ltd.’s Fourth Quarter and Full Year 2021 Earnings Results Conference Call. All participa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...