
Revenue Performance - Total revenue for the three months ended June 30, 2024, was $2,207,000, a 104% increase from $1,081,000 for the same period in 2023[9] - Product revenue increased to $1,396,000 for the three months ended June 30, 2024, compared to $298,000 for the same period in 2023, representing a 368% growth[9] - Total revenue for the six months ended June 30, 2024, reached $3,330 million, compared to $2,057 million for the same period in 2023, marking a 62% increase[39] - Total U.S. revenue for the three months ended June 30, 2024, was $184 thousand, compared to $133 thousand in the same period of 2023, reflecting a 38% increase[39] - Total OUS revenue for the three months ended June 30, 2024, was $2.023 million, significantly higher than $948 thousand in the same period of 2023, indicating a 113% growth[39] Financial Losses - Net loss for the three months ended June 30, 2024, was $(25,749,000), compared to $(20,662,000) for the same period in 2023, indicating a 25% increase in losses[9] - The company reported a comprehensive loss of $(25,922,000) for the three months ended June 30, 2024, compared to $(20,388,000) for the same period in 2023[9] - The company reported a net loss of $48.246 million for the six months ended June 30, 2024, compared to a net loss of $42.880 million for the same period in 2023, indicating an increase in losses[18] - The company had an accumulated deficit of $987.6 million as of June 30, 2024, highlighting ongoing financial challenges[24] Operating Expenses - Total operating expenses for the three months ended June 30, 2024, were $23,090,000, up from $18,870,000 for the same period in 2023, reflecting a 22% increase[9] - Research and development expenses for the six months ended June 30, 2024, were $15,722,000, down from $19,119,000 for the same period in 2023, a decrease of 18%[9] - Stock-based compensation for the six months ended June 30, 2024, was $3.273 million, slightly down from $3.894 million in the same period of 2023[18] Cash and Liquidity - Cash and cash equivalents decreased to $7,782,000 as of June 30, 2024, down from $17,096,000 as of December 31, 2023[11] - The company experienced a net cash used in operating activities of $28.228 million for the six months ended June 30, 2024, compared to $35.204 million for the same period in 2023, indicating improved cash flow management[18] - Cash and cash equivalents at the end of the period were $9.299 million, compared to $9.029 million at the end of the same period in 2023, showing a slight increase[18] Assets and Liabilities - Total current liabilities increased significantly to $39,920,000 as of June 30, 2024, compared to $12,628,000 as of December 31, 2023[11] - The total assets of the company were $38,502,000 as of June 30, 2024, a decrease from $59,086,000 as of December 31, 2023[11] - Total liabilities as of June 30, 2024, amounted to $19,997,000, including warrant liabilities of $5,597,000[49] - Contingent consideration increased significantly from $2,220,000 on December 31, 2023, to $14,400,000 on June 30, 2024, due to the probability-weighted fair value related to a potential merger[57] Merger and Strategic Developments - The company entered into a Merger Agreement with KARL STORZ Endoscopy-America, Inc., where each share of common stock will be converted into $0.35 in cash upon completion of the merger[23] - The company is developing the LUNA™ Surgical System, a next-generation robotic and instrument system aimed at enhancing surgical outcomes through digital technology[21] - The company is focused on the commercialization of the Senhance System, which is the first digital multi-port laparoscopic platform designed to enhance minimally invasive surgery[21] - The company requires additional capital to fund operating losses and continue its business plan, raising concerns about its ability to continue as a going concern[25] Customer Concentration and Revenue Distribution - The Company had three customers accounting for 26%, 13%, and 11% of net accounts receivable as of June 30, 2024[44] - The Company had two customers contributing 43% and 11% of revenue for the three months ended June 30, 2024, compared to no customers exceeding 10% in the same period last year[99] - For the three months ended June 30, 2024, the Company generated 8% of its revenue from the U.S., down from 12% in the same period last year[99] - EMEA accounted for 84% of revenue for the three months ended June 30, 2024, an increase from 67% year-over-year[99] Tax and Regulatory Matters - The company incurred a total tax expense of approximately $0.07 million for the three months ended June 30, 2024, compared to a tax benefit of $0.01 million for the same period in 2023[73] - The effective tax rate for the three months ended June 30, 2024, was (0.3)%, compared to 0.1% for the same period in 2023[72] - The Company is currently evaluating the impact of recently issued accounting standards, including ASU No. 2023-07 and ASU No. 2023-09, which may affect future disclosures[31][34] Stock and Equity - Stock options outstanding increased to 15,886,489 as of June 30, 2024, with a weighted average exercise price of $2.07[82] - The company granted 14,953,974 restricted stock units during the six months ended June 30, 2024, resulting in unvested shares totaling 20,427,833[85] - The total potential common shares not included in the computation of diluted net loss per share increased to 61,144,822 as of June 30, 2024[94] Future Outlook and Risks - The Company anticipates potential risks related to the Merger, including a termination fee of $3.6 million if the agreement is not completed[105] - The Company’s financial performance is subject to various risks and uncertainties that could impact future results, particularly regarding the Merger[105]