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Myomo(MYO) - 2023 Q4 - Annual Report
2024-03-08 02:38
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 (State or other jurisdiction of incorporation or organization) 137 Portland St., 4 Floor, Boston, Massachusetts 02114 (Address of principal executive offices) (Zip Code) th Delaware 47-0944526 (I.R.S. Employer Identification No.) Registrant's telephone number, including ...
Myomo(MYO) - 2023 Q4 - Earnings Call Transcript
2024-03-08 01:10
Myomo, Inc. (NYSE:MYO) Q4 2023 Earnings Conference Call March 7, 2024 4:30 PM ET Company Participants Kim Golodetz - Investor Relations, LHA Paul Gudonis - Chairman & Chief Executive Officer Dave Henry - Chief Financial Officer Conference Call Participants Anthony Vendetti - Maxim Group Edward Woo - Ascendant Capital Ben Haynor - Alliance Global Partners Operator Hello, and welcome to the Myomo Fourth Quarter 2023 Earnings Call. All participants will be in a listen-only mode. [Operator Instructions] Please ...
Myomo(MYO) - 2023 Q3 - Quarterly Report
2023-11-07 22:29
Revenue Growth - Product revenue for the three months ended September 30, 2023, was $5,029,523, a 27% increase from $3,968,201 in the same period of 2022[110] - Total revenue for the nine months ended September 30, 2023, reached $14,484,775, reflecting a 26% increase compared to $11,513,702 in the prior year[110] - The company recorded a license revenue of $1,764,920 for the nine months ended September 30, 2023, a 76% increase from $1,000,000 in the previous year[110] Gross Margin and Expenses - Gross margin improved to 68.7% for the three months ended September 30, 2023, up from 66.5% in the same period of 2022[114] - Research and development expenses increased by approximately $26,800, or 4%, for the three months ended September 30, 2023, compared to the same period in 2022[118] - Operating expenses for the nine months ended September 30, 2023, were $15,875,870, a slight decrease of 1% compared to $16,068,330 in the same period of 2022[116] - Selling, general and administrative expenses (SG&A) increased by approximately $30,700, or 1%, during the three months ended September 30, 2023, compared to the same period in 2022[121] Cash Flow and Financial Position - As of September 30, 2023, cash and cash equivalents were $6,911,747, and working capital was approximately $10.3 million[130] - The net cash used in operating activities for the nine months ended September 30, 2023, was $(3,817,019), compared to $(7,769,321) for the same period in 2022[140] - Adjusted EBITDA for the three months ended September 30, 2023, was $(1,658,648), compared to $(2,468,910) for the same period in 2022[129] Strategic Initiatives - The company has submitted six claims to CMS, with five claims already receiving rental payments, indicating progress in reimbursement efforts[107] - A joint venture in China has been established, with a minimum investment commitment of $8 million and up to $20 million over five years[104] - The company plans to continue expanding sales and marketing efforts, particularly in international markets, while developing a pediatric version of the MyoPro[108] Reimbursement Changes - The company expects a change in CMS reimbursement policy to allow lump-sum payments for MyoPro sales starting January 1, 2024, which may improve cash flow[106] - CMS issued a final rule effective January 1, 2024, changing the reimbursement approach for MyoPro from rental to a lump sum[133] Workforce and Cost Management - The company reduced its workforce by approximately 12% in January 2023 as part of cost reduction activities[132] - In August 2023, the company completed a public equity offering generating proceeds of approximately $3.9 million[131] Going Concern - The company believes there is substantial doubt regarding its ability to continue as a going concern due to cash flow uncertainties[131]
Myomo(MYO) - 2023 Q2 - Quarterly Report
2023-08-09 20:18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of Registrant as Specified in its Charter) Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-38109 MYOMO, INC. Delaware 47-0944526 (State or Other Jurisdiction of (I ...
Myomo(MYO) - 2023 Q1 - Earnings Call Transcript
2023-05-11 22:20
Myomo, Inc. (NYSE:MYO) Q1 2023 Results Conference Call May 10, 2023 4:30 PM ET Company Participants Kim Golodetz - Investor Relations, LHA Paul Gudonis - Chief Executive Officer Dave Henry - Chief Financial Officer Conference Call Participants Ben Haynor - Alliance Global Partners Scott Henry - ROTH Capital Jim Sidoti - Sidoti & Company Edward Woo - Ascendant Capital Operator Good afternoon, and welcome to the Myomo First Quarter 2023 Earnings Conference Call. All participants will be in a listen-only mode. ...
Myomo(MYO) - 2023 Q1 - Quarterly Report
2023-05-10 20:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-38109 MYOMO, INC. (Exact name of Registrant as Specified in its Charter) Delaware 47-0944526 (State or Other Jurisdiction of ( ...
Myomo(MYO) - 2022 Q4 - Annual Report
2023-03-13 19:49
Financial Performance and Concerns - The company reported a history of operating losses, raising substantial doubt about its ability to continue as a going concern[13]. - The company reduced its workforce by 12% in January 2023, aiming to save approximately $2 million in 2023[55]. - The company has approximately $5.3 million in unrestricted cash and cash equivalents as of December 31, 2022, held for working capital purposes[327]. - The company’s future success is dependent on navigating healthcare regulations and reimbursement challenges that could materially affect its financial condition[89]. Product Development and Innovation - The company expects to introduce the MyoPal device for pediatric use during calendar year 2024[25]. - The MyoPro is a myoelectric-controlled upper limb brace designed to support patients with neuromuscular disorders, enabling improved functional activities of daily living[20]. - The MyoPro device is currently listed as a Class II (510(k)-exempt) device by the FDA, and it is believed to be the only device that helps neuromuscular-impaired individuals regain function using their muscle signals[22]. - The MyoPro 2, introduced in June 2017, features improvements in control technology and a longer-lasting battery[49]. - The company is committed to investing in R&D to enhance products and support clinical research studies[48]. - The company plans to continue filing additional patent applications over time to protect its innovations[67]. Market and Reimbursement - The addressable market in the U.S. for products aimed at individuals with upper extremity paralysis is estimated at 3 million existing cases, with approximately 250,000 new patients added annually due to strokes and other afflictions[26]. - The market for myoelectric braces is new, and the rate of adoption remains uncertain, with potential inaccuracies in market assumptions[13]. - The MyoPro devices are typically reimbursed by various health insurance plans, including Medicare and Medicaid, but reimbursement levels may not cover the costs associated with the device and services[81][84]. - The company is working with CMS to publish reimbursement guidelines for the MyoPro, with a request made in June 2022 to change its benefit category to a brace[83]. - As of December 31, 2022, the reimbursement pipeline included 1,153 patients, a 43% increase from 808 patients in the previous year[55]. - The backlog of MyoPro units was 164, with an estimated revenue value of $7.6 million, reflecting a 9% increase from the previous year[55]. - The company plans to focus on patients in the Adjusted Pipeline, which was 794 patients as of December 31, 2022, a 50% increase from 528 patients in the previous year[55]. Intellectual Property and Regulatory Compliance - The company holds 20 issued patents in the U.S. and various countries, with multiple pending applications, extending its patent portfolio to 2039[30]. - Myomo holds two core patents licensed from MIT, with the first patent expiring on December 1, 2023, and the second on November 21, 2023[64]. - Myomo's quality system has been certified to the Medical-Device-Single-Audit-Program (MDSAP) for compliance in multiple countries[73]. - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute and the False Claims Act[75]. - Myomo's operations are regulated by the FDA and other governmental agencies, affecting product development and market availability[72]. Partnerships and Distribution - The company has established relationships with major rehabilitation facilities, including the Mayo Clinic and Cleveland Clinic, to evaluate and refer patients for the MyoPro[32]. - The company has entered into distribution agreements in the UK, Denmark, Germany, Italy, and Australia, receiving orders from providers outside the U.S. in 2022[56]. Employee and Organizational Strategy - As of December 31, 2022, the company employed a total of 100 full-time employees and 6 part-time employees, with a headcount reduction of 12% in January 2023[93]. - The company aims to attract and retain skilled employees through competitive salaries, bonuses, and equity ownership opportunities[94].
Myomo(MYO) - 2022 Q4 - Earnings Call Transcript
2023-03-13 16:32
Myomo, Inc (NYSE:MYO) Q4 2022 Earnings Conference Call March 13, 2023 10:00 AM ET Company Participants Kim Golodetz - Investor Relations, LHA Paul Gudonis - Chief Executive Officer Dave Henry - Chief Financial Officer Conference Call Participants Jim Sidoti - Sidoti & Company Edward Woo - Ascendiant Capital Ben Haynor - Alliance Global Partners Jeremy Pearlman - Maxim Group Operator Good morning, and welcome to the Myomo, Inc. Fourth Quarter and Full Year 2022 Earnings Conference Call. All participants will ...
Myomo(MYO) - 2022 Q3 - Earnings Call Transcript
2022-11-11 01:08
Myomo, Inc. (NYSE:MYO) Q3 2022 Earnings Conference Call November 10, 2022 4:30 AM ET Company Participants Kim Golodetz - Investor Relations, LHA Paul Gudonis - Chief Executive Officer Dave Henry - Chief Financial Officer Conference Call Participants Ben Haynor - Alliance Global Partners Jim Sidoti - Sidoti & Company Edward Woo - Ascendiant Capital Operator Welcome to the Myomo Incorporated Third Quarter 2022 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Af ...
Myomo(MYO) - 2022 Q3 - Quarterly Report
2022-11-10 21:28
Revenue Performance - Product revenue for the three months ended September 30, 2022, decreased by approximately $415,800 or 9% compared to the same period in 2021, while total revenue for the nine months increased by approximately $1,689,000 or 17%[102]. - The company reported a gross profit of $2,636,984 for the three months ended September 30, 2022, down from $3,273,753 in the same period of 2021, reflecting a decrease of $636,769 or 19%[99]. - The company received $1 million in licensing revenue from its joint venture partner in China during the nine months ended September 30, 2022[102]. Expenses - Gross margin for the three months ended September 30, 2022, was 66.5%, down from 74.7% in the same period of 2021, primarily due to higher component costs and increased warranty reserves[104]. - Research and development expenses increased by approximately $49,200 or 8% for the three months ended September 30, 2022, and by $213,100 or 12% for the nine months ended September 30, 2022, compared to the same periods in 2021[108]. - Total operating expenses for the three months ended September 30, 2022, were $5,455,625, an increase of $151,601 or 3% compared to the same period in 2021[106]. - Selling, general and administrative expenses (SG&A) increased by approximately $102,400 (2%) and $1,103,100 (8%) for the three and nine months ended September 30, 2022, respectively, compared to the same periods in 2021[112]. - Adjusted EBITDA for the three months ended September 30, 2022, was $(2,463,911), compared to $(1,691,598) for the same period in 2021, and for the nine months ended September 30, 2022, it was $(7,381,985) compared to $(6,636,050) in 2021[119]. Cash Flow and Capital - Cash and cash equivalents decreased to $7,420,020 as of September 30, 2022, from $15,524,378 as of December 31, 2021[120]. - The company used approximately $7.8 million in cash for operating activities during the nine months ended September 30, 2022[120]. - The net cash used in operating activities for the nine months ended September 30, 2022, was primarily to fund a net loss of approximately $8.6 million[126]. - The company expects that the available cash will fund operations into the third quarter of 2023, after which further capital will be needed[122]. - The company entered into a Common Stock Purchase Agreement with Keystone Capital Partners, establishing an equity line facility with a maximum amount of $5.0 million[121]. Strategic Initiatives - The company has been focusing on expanding sales and marketing efforts, particularly in the German and other international markets, and developing a pediatric version of the MyoPro, named MyoPal[98]. - The joint venture in China, established in August 2021, has a minimum purchase commitment of $10.75 million in MyoPro Control System units over the next ten years[96]. - The company expects to continue increasing R&D costs annually as it develops additional products and enhances existing ones[107]. Going Concern - The company recorded an income tax expense for the three and nine months ended September 30, 2022, due to higher taxable income driven by increased revenue[114]. - The company reported a loss on investment in minority interest of $49,860 for the nine months ended September 30, 2022[119]. - The company plans to mitigate concerns about its ability to continue as a going concern by raising additional capital and increasing patient pipeline[124].