Soleno Therapeutics(US:SLNO)2025-11-04 22:01Revenue and Sales Performance - Product revenue, net was $66.0 million for the three months ended September 30, 2025, due to sales of VYKAT XR after FDA approval, compared to zero for the same period in 2024 [121] - Product revenue, net for the nine months ended September 30, 2025, was $98.7 million, attributed to VYKAT XR sales post-FDA approval, compared to zero for the same period in 2024 [129] - Cost of goods sold was $1.1 million for the three months ended September 30, 2025, due to VYKAT XR sales, compared to zero for the same period in 2024 [122] - Cost of goods sold for the nine months ended September 30, 2025, was $1.8 million, compared to zero for the same period in 2024, following FDA approval of VYKAT XR in March 2025 [130] Operating Income and Expenses - Operating income for the three months ended September 30, 2025, was $22.1 million, a significant increase of $102.3 million compared to an operating loss of $80.2 million in the same period of 2024 [120] - Total operating expenses for the nine months ended September 30, 2025, were $128.8 million, a slight increase of 0% compared to $128.6 million in the same period of 2024 [128] - Research and development expenses decreased by 72% to $8.4 million for the three months ended September 30, 2025, compared to $30.1 million in the same period of 2024 [123] - Research and development expenses decreased to $31.1 million for the nine months ended September 30, 2025, from $57.1 million in the same period of 2024, with a notable reduction in costs related to NDA submission and clinical activities [131] - Selling, general and administrative expenses were $33.8 million for the three months ended September 30, 2025, down 31% from $49.2 million in the same period of 2024 [124] - Selling, general and administrative expenses increased to $91.3 million for the nine months ended September 30, 2025, from $68.6 million in the same period of 2024, driven by hiring for commercial launch and increased marketing activities [132] Net Loss and Financial Position - Net loss for the nine months ended September 30, 2025, was $22.5 million, a reduction of $97.4 million compared to a net loss of $119.9 million in the same period of 2024 [128] - The company reported a net loss of $22.5 million for the nine months ended September 30, 2025, with an accumulated deficit of $474.7 million [136] Cash and Securities - Cash and cash equivalents totaled $246.7 million, with marketable securities at $309.4 million, as of September 30, 2025 [136] - The company raised $230.0 million in a public offering of common stock in July 2025, with gross proceeds before expenses [138] - Net cash used in operating activities was $1.9 million for the nine months ended September 30, 2025, a significant decrease from $45.1 million in the same period of 2024 [141] - The company used $267.9 million for purchases of marketable securities during the nine months ended September 30, 2025, compared to $308.9 million in the same period of 2024 [145] - The company believes existing cash and marketable securities will be sufficient to meet working capital needs for the next twelve months, depending on the success of VYKAT XR commercialization [140] Fair Value of Contingent Consideration - The fair value of contingent consideration payable was estimated at $19.5 million as of September 30, 2025, reflecting a $0.6 million increase from the previous quarter [125] - The fair value of contingent consideration related to VYKAT XR sales milestones increased to $19.5 million as of September 30, 2025, up $4.7 million from December 31, 2024, due to the product's FDA approval [133] Interest Income - Interest income increased by 36% to $11.8 million for the nine months ended September 30, 2025, compared to $8.7 million in the same period of 2024 [128]