Revenue Performance - Product revenue for the three months ended September 30, 2024, was $9,207,586, representing an increase of 83% compared to $5,029,523 in the same period of 2023[101]. - Total revenue for the nine months ended September 30, 2024, was $20,482,742, up 41% from $14,484,775 in the same period of 2023[101]. - Revenues from Medicare Part B beneficiaries represented 55% and 44% of product revenues for the three and nine months ended September 30, 2024, respectively[98]. Profitability Metrics - Gross profit for the three months ended September 30, 2024, was $6,945,555, a 99% increase from $3,488,848 in the same period of 2023[101]. - The gross margin for the three months ended September 30, 2024, was 75.4%, compared to 68.7% in the same period of 2023, reflecting a 6.7% improvement[101]. - The company reported a net loss of approximately $966,409 for the three months ended September 30, 2024, compared to a net loss of $2,029,016 for the same period in 2023[118]. - The company reported a net loss of approximately $5.7 million for the nine months ended September 30, 2023, adjusted for non-cash expenses of about $1.3 million[125]. - Adjusted EBITDA for the three months ended September 30, 2024, was $(584,686), an improvement from $(1,658,648) in the same period of 2023[118]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $7,903,108, a 43% increase from $5,513,217 in the same period of 2023, while for the nine months, they were $20,531,494, up 29% from $15,875,876[1]. - Research and development (R&D) expenses increased by approximately $531,600 (74%) and $1,453,800 (83%) for the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to higher payroll costs from increased headcount[109]. - Selling, clinical, and marketing (SC&M) expenses rose by approximately $1,014,100 (42%) and $1,850,600 (28%) during the three and nine months ended September 30, 2024, respectively, driven by higher payroll costs and increased advertising and travel expenses[110]. - General and administrative (G&A) expenses increased by approximately $844,200 (35%) and $1,351,200 (18%) for the three and nine months ended September 30, 2024, respectively, mainly due to higher payroll costs and increased legal fees[112]. Cash Flow and Liquidity - As of September 30, 2024, the company had cash and cash equivalents of $6,622,675, down from $6,871,306 as of December 31, 2023[119]. - The company utilized approximately $6.7 million in cash for operating activities during the nine months ended September 30, 2024, primarily to fund a net loss of approximately $5.9 million[120]. - Net cash used in operating activities for the nine months ended September 30, 2024, was approximately $6.7 million, compared to $3.8 million in 2023, indicating an increase in cash outflow[126]. - Cash provided by investing activities was $1.6 million for the nine months ended September 30, 2024, compared to cash used of $4.3 million in 2023, reflecting a significant change in investment strategy[127]. - Cash generated from financing activities was $5.4 million in 2024, down from $9.7 million in 2023, primarily due to net proceeds from equity offerings[128]. - The net decrease in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2024, was $126,369, compared to an increase of $1.6 million in 2023[126]. - The company has access to a line of credit of up to $4.0 million, which was undrawn as of the issuance date of the report, with approximately $0.9 million available as of September 30, 2024[121]. Future Outlook - The company expects to achieve operating cash flow breakeven on a quarterly basis in the fourth quarter of 2024, contingent on meeting supply chain requirements and managing advertising expenses[123]. - The joint venture company is expected to begin enrolling patients in a clinical trial for its version of MyoPro by the end of 2024[95]. Investments and Joint Ventures - The company completed a registered direct equity offering on January 19, 2024, generating net proceeds of approximately $5.4 million to expand clinical and manufacturing capacity[96]. - The joint venture in China has committed to invest a minimum of $8 million and up to $20 million over five years to manufacture and sell products in the greater China region[93]. Accounting and Compliance - There have been no material changes to critical accounting policies from those described in the Annual Report for the year ended December 31, 2023[130]. - The company has adopted new accounting standards as detailed in the Quarterly Report[131]. - The company does not have applicable market risk disclosures as a smaller reporting company[132]. - Significant estimates include deferred tax valuation allowances and stock-based compensation, which could impact future financial results[129]. Foreign Exchange Impact - The effect of foreign exchange rate changes on cash was a gain of $6,412 in 2024, compared to a loss of $6,610 in 2023[126].
Myomo(MYO) - 2024 Q3 - Quarterly Report