REGENXBIO(US:RGNX)2025-05-12 20:11Financial Performance - Revenues for Q1 2025 were $89.0 million, a significant increase from $15.6 million in Q1 2024, primarily due to $71.8 million of license and service revenue from the collaboration with Nippon Shinyaku[13] - Net income for Q1 2025 was $6.1 million, or $0.12 per share, compared to a net loss of $63.3 million, or $1.38 per share, in Q1 2024[17] - Total revenues for Q1 2025 reached $89,012,000, a significant increase of 469% compared to $15,622,000 in Q1 2024[26] - License and royalty revenue surged to $87,049,000, up from $15,344,000 in the same period last year, marking a growth of 467%[26] - Basic net income per share improved to $0.12 in Q1 2025, compared to a loss of $1.38 per share in Q1 2024[26] - The company reported a comprehensive income of $6,062,000 for Q1 2025, compared to a comprehensive loss of $62,130,000 in Q1 2024[26] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $272.7 million as of March 31, 2025, up from $244.9 million at the end of 2024, mainly due to a $110 million upfront payment from the Nippon Shinyaku partnership[12] - Total current assets increased to $313,237,000 as of March 31, 2025, compared to $278,001,000 at the end of 2024, reflecting a growth of 12.7%[25] - Total assets rose to $490,929,000, up from $465,989,000 at the end of 2024, indicating a growth of 5.3%[25] - Total liabilities increased to $216,732,000 from $206,338,000, representing a rise of 5.7%[25] Expenses - Research and development expenses for Q1 2025 were $53.1 million, a decrease from $54.8 million in Q1 2024, primarily due to lower clinical trial expenses[15] - General and administrative expenses increased to $20.3 million in Q1 2025 from $18.3 million in Q1 2024, mainly due to higher personnel-related costs[16] - Total operating expenses decreased to $76,885,000 in Q1 2025 from $79,485,000 in Q1 2024, a reduction of 3.9%[26] Clinical Development - The pivotal trial for RGX-202 in Duchenne muscular dystrophy is more than half enrolled, with completion expected in 2025 and a Biologics License Application (BLA) submission planned for mid-2026[5] - REGENXBIO expects to initiate commercial supply manufacturing for RGX-202 in Q3 2025, with all production sourced in the U.S.[6] - The FDA is expected to accept the BLA for clemidsogene lanparvovec (RGX-121) in May 2025, with potential approval in the second half of 2025[14] Partnerships - The partnership with Nippon Shinyaku includes an upfront payment of $110 million and potential additional payments of up to $700 million upon achieving certain milestones[11] - REGENXBIO's cash runway is expected to fund operations into the second half of 2026, excluding potential milestone payments and monetization of a Priority Review Voucher[18]