InMode(INMD)
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InMode(INMD) - 2021 Q4 - Annual Report
2022-02-10 12:05
Product Development and Innovation - The company has developed ten product platforms, including BodyTite, Optimas, and Morpheus8, with two additional platforms introduced in 2021[36]. - The company emphasizes the importance of developing new products and identifying new markets to avoid obsolescence and maintain revenue growth[54]. - The company relies on its ability to enhance existing products and develop new ones for long-term growth, which is expensive and time-consuming[55]. - The company is developing additional RF energy-based platforms and handpieces for various medical specialties, including ophthalmology and ENT[195][196]. - The EmpowerRF platform targets women's health indications, while EvolveX replaces the previous Evolve platform, enhancing the product offerings[194]. - The company’s proprietary RF energy technologies allow for minimally invasive procedures with reduced risks compared to traditional surgical options[190]. - The company aims to satisfy unmet market demand by targeting patients who are averse to surgical procedures due to costs and risks[191]. - The company has a robust R&D pipeline focused on new minimally and non-invasive applications, targeting conditions such as cellulite and erectile dysfunction[219]. - The company has developed a modular product platform that allows for complementary treatments using a single system, increasing treatment versatility[218]. Market Dynamics and Competition - The surgical aesthetic solutions market is highly competitive, with rapid technological development and the need for continuous innovation to remain competitive[54]. - The company faces intense competition from both public and private companies, which could result in reduced prices and profit margins[56]. - The aesthetics market is characterized by rapid technological changes and evolving customer requirements, necessitating timely product introductions[59]. - The company aims to expand its customer base beyond traditional markets, targeting non-traditional customers such as ENTs and general practitioners[40]. Financial Performance and Risks - Revenue increased to approximately $357.6 million for the year ended December 31, 2021, up from $206.1 million in 2020 and $156.4 million in 2019, representing a growth of 73% year-over-year[199]. - Gross margin for the years ended December 31, 2021, 2020, and 2019 was approximately 85%, 85%, and 87%, respectively, with net income of approximately $165.1 million in 2021, up from $75.0 million in 2020 and $61.2 million in 2019[199]. - The company’s financial results may fluctuate due to various factors, including customer adoption rates and regulatory compliance[51][52]. - Economic uncertainty may lead to reduced demand for premium products, as customers may delay or reduce purchases during tight credit markets[87]. - The company is monitoring the creditworthiness of customers, as economic weakness could negatively affect cash flows and delay revenue recognition[88]. Regulatory and Compliance Challenges - The company’s products are subject to extensive FDA regulations, and failure to obtain necessary clearances could harm commercial operations[130]. - The FDA's 510(k) clearance process typically takes from three to 12 months, while premarket approval can take one to three years or longer, impacting product launch timelines[132]. - Regulatory changes or delays in obtaining clearances could adversely affect the company’s ability to introduce new products, impacting revenue and profitability[136]. - The company must maintain compliance with FDA's Quality System Regulation and laser performance standards, with inspections potentially impacting manufacturing operations[146]. - The company is subject to evolving healthcare laws and regulations, which could materially affect its business and operations[102]. Supply Chain and Operational Risks - The company faces significant risks, including reliance on a limited number of suppliers and contract manufacturers, which could impact product delivery and operational efficiency[53]. - The company outsources almost all manufacturing to a small number of subcontractors, which may lead to delivery issues if operations are interrupted or if orders exceed capacity[65]. - The company’s growth may be limited by challenges in managing operations and maintaining quality standards as it scales[48][49]. Customer Relationships and Sales Strategy - The company relies heavily on sales professionals to market and sell products worldwide, emphasizing the need for effective hiring and training to improve productivity[44]. - The success of the company's products depends on market acceptance and the ability to maintain strong relationships with healthcare professionals[36][43]. - The company has launched ten product platforms since 2010, including BodyTite, Optimas, and Morpheus8, which utilize RF energy technology for various aesthetic procedures[192]. - The company offers one of the most extensive training and ongoing support programs available to physicians in the aesthetic solutions market[198]. International Operations and Risks - International sales accounted for approximately 34% of total revenue for the year ended December 31, 2021, with expectations for increased future revenue from international markets[62]. - The company must navigate various risks associated with international sales, including political instability and regulatory compliance[64]. - Political, economic, and military instability in Israel may adversely affect the company's operations and financial results[173]. - Several Middle Eastern countries impose restrictions on doing business with Israel, which may limit the company's market opportunities[176]. Intellectual Property and Legal Matters - The company has issued six U.S. patents and one Korean patent, with fourteen pending patent applications in the U.S.[109]. - The company relies on a combination of patents and trademarks to protect its proprietary technology, but there is no guarantee these protections will be sufficient[107]. - The company may face substantial litigation costs related to intellectual property infringement claims, which could adversely affect its financial position[121]. - The company acknowledges that competitors may exploit jurisdictions where it lacks patent protection, potentially harming its competitive position[108]. Economic and Market Conditions - The ongoing COVID-19 pandemic has caused significant disruptions to global financial markets, potentially reducing the company's ability to access capital on favorable terms[85]. - The pandemic has led to restrictions on elective procedures in healthcare facilities, which may adversely affect sales and marketing efforts for products used in aesthetic procedures[80]. - The company has experienced challenges in maintaining customer relationships due to travel restrictions, impacting sales efforts and customer success initiatives[81]. - Exchange rate fluctuations pose a risk to earnings, particularly as a portion of revenues and expenses are incurred in currencies other than U.S. dollars[89]. - Cybersecurity risks have increased due to remote work arrangements, potentially exposing the company to liability and reputational harm[90].
InMode(INMD) - 2021 Q4 - Annual Report
2022-02-10 12:00
Exhibit 99.1 InMode Reports Record Fourth Quarter and Full Year 2021 Financial Results: Quarterly Revenue of $110.5M, 47% Year-Over-Year Growth GAAP Net Income of $52.7M, 46% Increase Compared to Q4 2020 YOKNEAM, Israel, Feb. 10, 2022, 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 Dec. 31, 2021. Fourth Quarter 2021 Highlights: Full Year 2021 Highlights: | U.S. ...
InMode(INMD) - 2021 Q3 - Earnings Call Transcript
2021-10-26 17:38
InMode Ltd. (NASDAQ:INMD) Q3 2021 Earnings Conference Call October 26, 2021 8:30 AM ET Company Participants Miri Segal - President, MS-IR Moshe Mizrahy - Chairman and CEO Shakil Lakhani - President, North America Yair Malca - CFO Dr. Spero Theodorou - CMO Conference Call Participants Travis Steed - Barclays Matthew Taylor - UBS Kyle Rose - Canaccord Genuity Mike Matson - Needham & Company Jeff Johnson - Robert W. Baird Operator Hello and welcome to the InMode Limited Third Quarter 2021 Earnings Conference C ...
InMode(INMD) - 2021 Q2 - Earnings Call Transcript
2021-07-28 18:19
InMode Ltd. (NASDAQ:INMD) Q2 2021 Earnings Conference Call July 28, 2021 8:30 AM ET Company Participants Miri Segal - Investor Relations Moshe Mizrahy - Chairman of Board and Chief Executive Officer Shakil Lakhani - President, North America Yair Malca - Chief Financial Officer Spero Theodorou - Chief Medical Officer Conference Call Participants Travis Steed - Barclays Matt Taylor - UBS Kyle Rose - Canaccord Genuity Mike Matson - Needham & Company Jeff Johnson - Baird Operator Good morning, and welcome to th ...
InMode(INMD) - 2021 Q1 - Earnings Call Transcript
2021-05-05 18:41
InMode Ltd (NASDAQ:INMD) Q1 2021 Earnings Conference Call May 5, 2021 8:30 AM ET Company Participants Miri Segal - MS-IR Moshe Mizrahy - Chairman & CEO Shakil Lakhani - President, North America Yair Malca - CFO Spero Theodorou - Chief Medical Officer Conference Call Participants Matt Taylor - UBS Kyle Rose - Canaccord Genuity Asaf Chandali - Oppenheimer Operator Good day, and welcome to the InMode Ltd. First Quarter 2021 Earnings Conference Call. [Operator Instructions]. I would now like to turn the confere ...
InMode(INMD) - 2020 Q4 - Earnings Call Transcript
2021-02-10 17:28
InMode Ltd. (NASDAQ:INMD) Q4 2020 Earnings Conference Call February 10, 2021 8:30 AM ET Company Participants Miri Segal - MS, IR Moshe Mizrahy - CEO & Chairman Michael Kreindel - Co-Founder & CTO Yair Malca - CFO Spero Theodorou - CMO Shakil Lakhani - President, North America Rafi Lickerman - VP, Finance Conference Call Participants Matt Taylor - UBS Kyle Rose - Canaccord Jeff Johnson - Baird Asaf Barel Chandali - Oppenheimer Operator Good day and welcome to the InMode Limited Fourth Quarter and Full-Year 2 ...
InMode(INMD) - 2020 Q4 - Annual Report
2021-02-10 12:19
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, 2020 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 ...
InMode(INMD) - 2020 Q3 - Earnings Call Transcript
2020-11-12 20:04
Financial Data and Key Metrics Changes - InMode generated record revenue of $59.7 million in Q3 2020, a 49% increase from Q3 2019 [8] - Net income on a GAAP basis was $23.9 million, and on a non-GAAP basis, it was $26.6 million [8] - GAAP diluted earnings per share were $0.57, compared to $0.42 in Q3 2019, while non-GAAP diluted earnings per share were $0.63, up from $0.42 [20] - The company increased its full-year 2020 revenue guidance range to $192 million to $195 million [12] Business Line Data and Key Metrics Changes - Approximately 58% of revenue came from surgical platforms, 35% from hands-free platforms, and 7% from traditional laser and non-invasive RF platforms [8] - International revenue grew 109% year-over-year, driven by marketing and sales activities in various countries [9][17] Market Data and Key Metrics Changes - The company reported strong demand in North America for minimally invasive and hands-free devices, confirming the effectiveness of their sales strategy during the pandemic [13] - The international market doubled year-over-year in Q3, with significant growth in China, Brazil, Mexico, and Korea [44] Company Strategy and Development Direction - InMode plans to introduce two new platforms targeting gynecology, ENT, and ophthalmology markets in 2021 and beyond [11] - The company is committed to investing in R&D, expanding its sales force, and enhancing marketing efforts despite the pandemic [12][27] - A share repurchase program of up to 1 million shares was announced, reflecting confidence in the company's future [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued demand for their technologies, citing a shift in consumer spending towards aesthetic procedures due to reduced travel and entertainment expenses [37] - The company remains focused on maintaining operations and growth despite the ongoing challenges posed by COVID-19 [45] Other Important Information - The company has a strong balance sheet with cash and cash equivalents totaling $234.3 million as of September 30, 2020 [20] - Operating expenses increased by 42.4% year-over-year, primarily due to sales and marketing investments [18] Q&A Session Summary Question: About the commercial organization and growth plans - Management confirmed ongoing investments in R&D and sales force, including expansion in France and China [27] Question: On the share buyback strategy - The company plans to repurchase shares opportunistically, starting with the approved 1 million shares [29] Question: Importance of recent peer-reviewed studies - Management emphasized the role of studies in supporting marketing efforts and differentiating from competitors [31] Question: Insights on market demand and consumer behavior - There is observed pent-up demand for aesthetic procedures, with clinics reporting busier operations than usual [37][41] Question: Update on international market performance - The international market is expected to continue growing, with specific focus on China and South America despite challenges [44][45] Question: Installed base split and platform utilization - Out of 6,400 systems installed worldwide, 3,500 are in the US, with an increase in the number of platforms per office [52] Question: Revenue growth expectations for 2021 - Management indicated that revenue growth trends could continue similarly to previous years, with guidance to be provided in the next earnings call [54]
InMode(INMD) - 2020 Q2 - Earnings Call Transcript
2020-08-05 16:47
InMode Ltd. (NASDAQ:INMD) Q2 2020 Earnings Conference Call August 5, 2020 8:30 AM ET Company Participants Miri Segal - MS, IR Moshe Mizrahy - CEO & Chairman Michael Kreindel - Co-Founder and CTO Shakil Lakhani - President of InMode, North America Yair Malca - CFO Spero Theodorou - Chief Medical Officer Conference Call Participants Matt Taylor - UBS Kristen Stewart - Barclays Kyle Rose - Canaccord Jeff Johnson - Baird Operator Good morning and welcome to the InMode Second Quarter 2020 Earnings Conference Cal ...
InMode(INMD) - 2020 Q1 - Earnings Call Transcript
2020-05-06 20:20
InMode Ltd. (NASDAQ:INMD) Q1 2020 Earnings Conference Call May 6, 2020 8:30 AM ET Prepared Remarks provided By The Company Company Participants Miri Segal - MS, Investor Relations Moshe Mizrahy - Chief Executive Officer & Chairman Shakil Lakhani - President of InMode, North America Yair Malca - Chief Financial Officer Spero Theodorou - Chief Medical Officer Conference Call Participants Matt Taylor - UBS Kristen Stewart - Barclays Kyle Rose - Canaccord Jeff Johnson - Baird Operator Welcome to the InMode Limi ...