Y-mAbs(US:YMAB)2024-11-08 12:18Financial Performance - Product revenue for the three months ended September 30, 2023, was $18.461 million, a decrease from $19.954 million in the same period last year, representing a decline of approximately 7.5%[17] - Total revenues for the nine months ended September 30, 2023, were $61.190 million, compared to $61.456 million for the same period last year, indicating a slight decrease of about 0.4%[17] - The net loss for the three months ended September 30, 2023, was $6.998 million, compared to a net loss of $7.747 million in the same period last year, showing an improvement of approximately 9.7%[17] - The comprehensive loss for the three months ended September 30, 2023, was $8.081 million, compared to a comprehensive loss of $6.941 million in the same period last year, indicating a decline of about 16.4%[17] - The company reported a net loss per share of $0.16 for the three months ended September 30, 2023, compared to a net loss per share of $0.18 in the same period last year[17] - The net loss for the nine months ended September 30, 2024, was $22,876,000, an increase from a net loss of $20,439,000 for the same period in 2023[22] - The net loss for the three months ended September 30, 2024, was $6,998,000, compared to a net loss of $7,747,000 for the same period in 2023, indicating an improvement of 9.7%[52] - The net loss for the nine months ended September 30, 2024, was $22.8 million, compared to a net loss of $20.4 million in 2023, reflecting a 12% increase in losses[159] Expenses - Research and development expenses for the three months ended September 30, 2023, were $11.168 million, down from $15.358 million in the prior year, reflecting a decrease of approximately 27%[17] - Selling, general, and administrative expenses increased to $13.613 million for the three months ended September 30, 2023, compared to $10.200 million in the same period last year, marking an increase of about 33.6%[17] - Research and development expenses decreased by $4.2 million, or 27%, to $11.2 million for the three months ended September 30, 2024, compared to $15.4 million in 2023[145] - Selling, general, and administrative expenses increased by $3.4 million, or 33%, to $13.6 million for the three months ended September 30, 2024[145] - Total operating costs and expenses increased to $86.4 million for the nine months ended September 30, 2024, from $83.9 million in 2023, an increase of 3%[159] Cash and Liquidity - Cash and cash equivalents decreased to $68,122,000 as of September 30, 2024, from $78,637,000 as of December 31, 2023[29] - The company expects that its cash and cash equivalents will be sufficient to fund operating expenses and capital expenditures for at least the next 12 months[29] - Cash and cash equivalents were $68.1 million as of September 30, 2024, down from $78.6 million as of December 31, 2023[176] - Net cash used in operating activities decreased by $5.4 million, or 28%, to $13.84 million for the nine months ended September 30, 2024, compared to $19.2 million for the same period in 2023[178] - Net cash provided by financing activities was $3.3 million for the nine months ended September 30, 2024, resulting from proceeds from exercised stock options[182] Equity and Stock - Total stockholders' equity decreased to $92.429 million as of September 30, 2023, down from $100.985 million at the end of the previous year, representing a decline of approximately 8.4%[15] - The Company has authorized a total of 105,500,000 shares, with 44,766,802 shares of common stock issued as of September 30, 2024[83][84] - The Company had 10,043,999 stock options outstanding, with a weighted average exercise price of $17.55[95] - Total stock-based compensation expense for the three months ended September 30, 2024 was $4,195,000, an increase of 74% compared to $2,410,000 for the same period in 2023[88] Revenue Sources - The company has funded operations primarily through proceeds from sales of common stock and revenue from DANYELZA sales[28] - Royalty revenue from distribution partners was $1,133,000 for the three months ended September 30, 2024, compared to $427,000 in the same period of 2023, marking a significant increase of 165%[48] - License revenue was $0 for the three months ended September 30, 2024, compared to $0.5 million in the same period of 2023[148] - License revenue remained flat at $0.5 million for both the nine months ended September 30, 2024, and 2023, related to regulatory-based milestone payments[164] Inventory and Assets - Total inventories increased to $27,048,000 as of September 30, 2024, from $17,013,000 as of December 31, 2023, representing a 59.3% increase[53] - The company did not record any inventory write-offs during the three and nine months ended September 30, 2024, contrasting with write-offs of $375,000 and $831,000 for the same periods in 2023[56] - Intangible assets related to DANYELZA amounted to $2,366,000 net as of September 30, 2024, down from $2,631,000 as of December 31, 2023, reflecting a decrease of 10.1%[58] Strategic Developments - The company completed a strategic restructuring plan in May 2023, resulting in a 35% reduction in workforce and recognizing restructuring expenses of $4,482,000 for the nine months ended September 30, 2023[14] - The company has deprioritized the development of radiolabeled omburtamab for CNS-LM and other pipeline programs to focus on DANYELZA and the SADA PRIT platform[123] - A license agreement with Nobelpharma Co., Ltd. for DANYELZA in Japan was signed on October 29, 2024, entitling the company to a non-refundable payment of $2,000,000 and up to $31,000,000 in milestone payments[15] Clinical Trials and Product Development - DANYELZA received accelerated approval from the FDA in November 2020 and is currently being commercialized in the United States, with a patent extension achieved through February 2034[110] - The ongoing pivotal-stage multicenter trial for DANYELZA is designed to satisfy FDA's accelerated approval confirmatory study requirements[111] - The company has 22 active sites in a multi-center Phase 2 trial evaluating naxitamab in combination with standard induction therapy for newly diagnosed high-risk neuroblastoma patients[113] Regulatory and Compliance - The company evaluated the effectiveness of its disclosure controls and procedures as of September 30, 2024, concluding they were effective at a reasonable assurance level[193] - There were no changes in internal control over financial reporting during the quarter ended September 30, 2024, that materially affected or are likely to materially affect internal control over financial reporting[195]