Financial Performance - For the three months ended September 30, 2024, the company reported a net loss of approximately $6.0 million, compared to a net income of $1.6 million for the same period in 2023[146]. - The accumulated deficit as of September 30, 2024, was $277.5 million, up from $257.2 million as of December 31, 2023[146]. - The company expects to continue incurring net losses for the foreseeable future, driven by ongoing research and development and regulatory approval efforts[146]. - The company incurred a net loss of approximately $16.2 million for the nine months ended September 30, 2024, adjusted for non-cash expenses of approximately $2.2 million[190]. Revenue and Sales - Revenue is currently derived primarily from the sale of the Esteem FI-AMEI implants, with new implantations expected to be minimal, potentially as low as zero per year[152]. - Upon commercialization of the Acclaim CI, the company expects revenues to exceed those from the Esteem FI-AMEI[153]. - Net revenues decreased by $24 thousand (30.0%) for the three months and $38 thousand (17.2%) for the nine months ended September 30, 2024, primarily due to a decrease in battery replacements caused by supply chain issues[173]. Expenses - Research and development expenses are primarily focused on the development of the Acclaim CI, with significant increases expected as the product progresses[146]. - Research and development expenses increased by $907 thousand (49.0%) for the three months and $1.8 million (30.6%) for the nine months ended September 30, 2024, driven by increased headcount and contractors in engineering and clinical departments[175]. - General and administrative expenses rose by $665 thousand (64.8%) for the three months and $1.2 million (27.3%) for the nine months ended September 30, 2024, mainly due to increased personnel-related costs and professional fees[178]. - Sales and marketing expenses decreased by $5 thousand (1.3%) for the three months but increased by $63 thousand (5.5%) for the nine months ended September 30, 2024, attributed to higher legal and professional fees[176]. - Total costs and operating expenses increased by $1.6 million (45.2%) for the three months and $3.1 million (25.8%) for the nine months ended September 30, 2024, driven by higher R&D and administrative costs[172]. Operating Loss - Operating loss increased by $1.6 million (46.9%) for the three months and $3.1 million (26.6%) for the nine months ended September 30, 2024, reflecting higher costs and lower revenues[172]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024 was $(13,561) thousand, compared to $(5,946) thousand for the same period in 2023[189]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $15,284 thousand, driven by $15 million proceeds from 2024 Term Loans and $1.7 million from the sale of common stock[192]. - The company had $4.4 million in cash as of September 30, 2024, compared to $4.2 million as of December 31, 2023[186]. - Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $1.5 million, primarily for purchases of property and equipment[191]. Regulatory and Product Development - The Acclaim CI, the company's lead product candidate, received FDA approval for an Investigational Device Exemption in October 2024, allowing a staged clinical trial to begin[145]. - The company anticipates obtaining FDA's decision on the Premarket Approval for the Acclaim CI in 2027, although this timeline is uncertain[145]. - The company expects to incur significant operating losses for the foreseeable future as it advances clinical development and funds FDA trials[186]. Market Conditions - Macroeconomic conditions, including inflation and market uncertainty, have impacted the company's financial performance and ability to raise capital[149]. - The company may seek additional capital through public or private equity offerings, debt financings, and strategic alliances, with no assurance of success[188].
ANZU SPECIAL(ANZU) - 2024 Q3 - Quarterly Report