REGENXBIO(US:RGNX)2025-11-06 12:30Financial Performance - Total revenues for Q3 2025 were $29.733 million, a 23.5% increase from $24.197 million in Q3 2024[18] - License and royalty revenue for Q3 2025 was $23.605 million, slightly down from $23.982 million in Q3 2024[18] - Net loss for Q3 2025 was $61.941 million, compared to a net loss of $59.597 million in Q3 2024, representing a 3.9% increase in loss[18] - The company reported a comprehensive loss of $61.843 million for Q3 2025, compared to a comprehensive loss of $57.913 million in Q3 2024[18] - The company generated a net cash used in operating activities of $71.7 million for the nine months ended September 30, 2025, an improvement from $141.5 million in the prior year[26] - The Company reported revenues of $29.7 million for the three months ended September 30, 2025, compared to $24.2 million for the same period in 2024, representing a 22.5% increase[139] Assets and Liabilities - Total assets increased to $525.203 million as of September 30, 2025, up from $465.989 million at the end of 2024, reflecting a 12.8% growth[17] - Total liabilities rose significantly to $363.751 million as of September 30, 2025, compared to $206.338 million at the end of 2024, marking a 76.2% increase[17] - The accumulated deficit as of September 30, 2025, was $1.058 billion, an increase from $932.149 million at the end of 2024[17] - Cash and cash equivalents increased to $58.802 million as of September 30, 2025, from $57.526 million at the end of 2024[17] - The company had cash, cash equivalents, and marketable securities totaling $302.0 million as of September 30, 2025, which is expected to fund operations for at least the next 12 months[30] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $168.688 million, up from $158.142 million in the same period of 2024[18] - Research and development expenses rose to $56.1 million in Q3 2025, up $1.7 million from $54.4 million in Q3 2024, despite a $3.7 million decrease in clinical trial costs[209] - The increase in research and development expenses was partially offset by a decrease of $4.6 million in costs associated with clinical trials and regulatory activities[215] Revenue Recognition and Agreements - Revenue is recognized in accordance with ASC 606, requiring the transfer of control of goods or services to customers[43] - The transaction price for license and collaboration agreements includes fixed and variable considerations, with milestone payments included if probable[52][54] - The Company received an up-front fee of $370.0 million from AbbVie under the collaboration agreement, with potential milestone payments of up to $1.38 billion[108] - The Company entered into a collaboration and license agreement with Nippon Shinyaku, receiving an up-front fee of $110.0 million and up to $700.0 million in milestone payments[116] - The Company recognized total revenues of $80.4 million under the Nippon Shinyaku Collaboration Agreement for the nine months ended September 30, 2025[123] Stock and Compensation - Stock-based compensation expense for the nine months ended September 30, 2025, was $26.2 million, slightly lower than the $28.9 million reported for the same period in 2024[26] - The total intrinsic value of restricted stock units vested during the nine months ended September 30, 2025, was $5.9 million[132] - The Company had $57.2 million of unrecognized stock-based compensation expense expected to be recognized over a weighted-average period of 2.3 years[128] Collaboration and Licensing - The NAV Technology Platform is being utilized by licensees in one commercial product, Zolgensma®, and in the development of several other licensed products[29] - The Company has selectively licensed its NAV Technology Platform to other biotechnology and pharmaceutical companies, indicating ongoing collaboration and market expansion efforts[29] - The Company retains all rights to any priority review vouchers that may be issued upon potential approvals of RGX-121 and RGX-111[116] Expenses - General and administrative expenses increased to $20.3 million in Q3 2025 from $19.4 million in Q3 2024, driven by higher professional services and consulting costs[210] - Interest expense surged to $13.2 million in Q3 2025, up from $0.8 million in Q3 2024, primarily due to increased interest under royalty monetization liabilities[212] Future Outlook - The company expects general and administrative expenses to increase as it prepares for the potential commercialization of product candidates, particularly RGX-202 and ABBV-RGX-314[186] - Future revenues from licensing agreements are uncertain and may fluctuate significantly due to the contingent nature of payments[175]