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InMode(INMD) - 2023 Q2 - Earnings Call Transcript
2023-07-27 15:13
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]
InMode(INMD) - 2023 Q2 - Quarterly Report
2023-07-27 11:00
Exhibit 99.1 InMode Reports Second Quarter 2023 Financial Results; Record Quarterly Revenue of $136.1M Represents 20% Year-Over-Year Growth YOKNEAM, Israel, July 27, 2023- 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, 2023. "We are pleased to report a record quarter with revenue of $136.1 million, as sales from our platforms and disposables were the strongest they'v ...
InMode(INMD) - 2023 Q1 - Earnings Call Transcript
2023-05-02 15:16
InMode Ltd. (NASDAQ:INMD) Q1 2023 Earnings Conference Call May 2, 2023 8:30 AM ET Conference Call Participants I'd now like to turn the conference over to Miri Segal, CEO of MS-IR. Please go ahead. Miri Segal - Investor Relations, MS-IR LLC Moshe Mizrahy - Chairman and CEO Shakil Lakhani - President, North America Yair Malca - Chief Financial Officer Spero Theodorou - Chief Medical Officer Operator Miri Segal Before we begin, I would like to remind our listeners that certain information provided on this cal ...
InMode(INMD) - 2023 Q1 - Quarterly Report
2023-05-02 11:00
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]
InMode(INMD) - 2022 Q4 - Earnings Call Transcript
2023-02-14 16:44
InMode Ltd. (NASDAQ:INMD) Q4 2022 Results Conference Call February 14, 2023 8:30 AM ET Company Participants Miri Segal - Investor Relations, MS-IR LLC Moshe Mizrahy - Chairman and Chief Executive Officer Dr. Michael Kreindel - Co-Founder and Chief Technology Officer Yair Malca - Chief Financial Officer Shakil Lakhani - President, North America Dr. Spero Theodorou - Chief Medical Officer Rafael Lickerman - VP of Finance Conference Call Participants Matt Miksic - Barclays Jon Lee - Jefferies Kyle Rose - Canac ...
InMode(INMD) - 2022 Q4 - Annual Report
2023-02-14 12:03
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]
InMode(INMD) - 2022 Q4 - Annual Report
2023-02-14 12:00
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(INMD) - 2022 Q3 - Earnings Call Transcript
2022-10-27 16:33
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 ...
InMode(INMD) - 2022 Q3 - Quarterly Report
2022-10-27 11:00
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(INMD) - 2022 Q2 - Earnings Call Transcript
2022-07-28 15:58
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 ...