Vanda Pharmaceuticals(US:VNDA)2025-10-30 11:23Financial Performance - Total revenues for the three months ended September 30, 2025, were $56,258,000, an increase of 18% compared to $47,651,000 for the same period in 2024[15] - Net product sales for the nine months ended September 30, 2025, reached $158,889,000, up from $145,587,000 in 2024, reflecting a growth of 9%[15] - The net loss for the three months ended September 30, 2025, was $22,586,000, compared to a net loss of $5,324,000 for the same period in 2024[15] - The company reported a comprehensive loss of $22,442,000 for the three months ended September 30, 2025, compared to a comprehensive loss of $4,292,000 in 2024[17] - For the nine months ended September 30, 2025, total revenue was $158,889,000, an increase of 9.5% from $145,587,000 in 2024[78] Expenses - Research and development expenses for the three months ended September 30, 2025, were $22,563,000, a 35% increase from $16,776,000 in 2024[15] - Selling, general and administrative expenses for the nine months ended September 30, 2025, totaled $174,973,000, compared to $107,132,000 in 2024, marking a significant increase of 63%[15] - Selling, general and administrative expenses rose significantly to $60,273,000 for the three months ended September 30, 2025, compared to $37,573,000 in 2024, marking a 60.5% increase[78] - Stock-based compensation expense for the nine months ended September 30, 2025, was $7.189 million, compared to $9.569 million for the same period in 2024, showing a decrease of approximately 25.5%[23] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $70,022,000, down from $102,316,000 as of December 31, 2024[14] - Total assets decreased to $601,140,000 as of September 30, 2025, from $656,204,000 as of December 31, 2024[14] - The total stockholders' equity decreased to $465.999 million as of September 30, 2025, down from $544.910 million at the end of 2024, reflecting a decline of approximately 14.4%[21] - Cash and cash equivalents decreased to $70.491 million at the end of September 2025, down from $102.785 million at the beginning of the period, representing a decrease of 31.4%[23] Inventory and Sales - Inventory as of September 30, 2025, totaled $10.039 million, an increase from $9.513 million as of December 31, 2024[45] - HETLIOZ net product sales for the nine months ended September 30, 2025, were $55.042 million, a decrease of 2.8% from $56.631 million in 2024[34] - The company recognized $5.8 million of net product sales during the nine months ended September 30, 2025, related to changes in estimates on variable consideration for performance obligations satisfied in previous periods[35] - Major customers accounted for 77% of total revenues for the nine months ended September 30, 2025, indicating a high concentration of revenue sources[36] Legal Matters - The company is involved in ongoing patent infringement lawsuits against Teva and Apotex regarding HETLIOZ, with a trial scheduled for August 3, 2026[79] - The company filed a lawsuit against the FDA challenging the approval of Teva's ANDA for its generic version of HETLIOZ, which is currently pending[80] - The company has filed multiple lawsuits against the FDA to compel the production of records under FOIA, with nine cases resolved in its favor[82] - The company is appealing a ruling against its request for Fast Track designation for tradipitant, with the case currently pending in the U.S. Supreme Court[82] Future Developments - The company is focused on obtaining FDA approvals for several products, including Bysanti and PONVORY, to expand its market presence[12] - Vanda is actively developing several new therapies, including a long-acting injectable formulation of Fanapt for schizophrenia and Tradipitant for various conditions, indicating ongoing innovation[29] - The Company has remaining milestone obligations of $10.0 million and $5.0 million for tradipitant's first approval in the U.S. and E.U., respectively[51] Shareholder Information - The weighted average shares outstanding for the three months ended September 30, 2025, were 59,091,478, compared to 58,261,961 for the same period in 2024[15] - As of September 30, 2025, there were 7,975,115 shares subject to outstanding options and RSUs under the equity incentive plans[61] - The Company granted 1,966,625 RSUs during the nine months ended September 30, 2025, with a weighted average grant date fair value of $4.46[68] Tax and Income - The Company recorded an income tax benefit of $21.4 million for the nine months ended September 30, 2025, compared to $2.4 million for the same period in 2024[71] - The company reported comprehensive income of $540 thousand for the nine months ended September 30, 2025, compared to a comprehensive loss of $30 thousand for the same period in 2024[23]