REGENXBIO(RGNX) - 2023 Q4 - Annual Results

Financial Performance - REGENXBIO reported revenues of $22.2 million for Q4 2023 and $90.2 million for the full year, down from $31.3 million and $112.7 million in the same periods of 2022, respectively[10]. - The company had a net loss of $62.9 million, or $1.43 per share, for Q4 2023, compared to a net loss of $59.9 million, or $1.38 per share, in Q4 2022; the full year net loss was $263.5 million, or $6.02 per share, compared to $280.3 million, or $6.50 per share, in 2022[15]. - Total revenues for the year ended December 31, 2023, were $90,242 thousand, down 20% from $112,724 thousand in 2022[24]. - License and royalty revenue decreased from $31,345 thousand in Q4 2022 to $22,213 thousand in Q4 2023, representing a decline of 29%[24]. - Net loss for the year ended December 31, 2023, was $263,494 thousand, compared to a net loss of $280,321 thousand in 2022, showing an improvement of 6%[24]. - Comprehensive loss for the year ended December 31, 2023, was $252,522 thousand, compared to $293,153 thousand in 2022, indicating a reduction of 13.8%[24]. - Basic and diluted net loss per share improved from $(6.50) in 2022 to $(6.02) in 2023[24]. - The company reported a total operating expense of $358,370 thousand for the year ended December 31, 2023, down from $375,600 thousand in 2022, a decrease of 4.6%[24]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $314.1 million as of December 31, 2023, down from $565.2 million a year earlier, with the current balance expected to fund operations into the second half of 2025[10][16]. - Total assets decreased from $833,268 thousand in December 2022 to $573,970 thousand in December 2023, a decline of approximately 31.2%[23]. - Total liabilities decreased from $317,073 thousand in December 2022 to $262,228 thousand in December 2023, a reduction of approximately 17.3%[23]. - Stockholders' equity fell from $516,195 thousand in December 2022 to $311,742 thousand in December 2023, a decline of about 39.5%[23]. Research and Development - Research and development expenses for Q4 2023 were $55.7 million, down from $62.5 million in Q4 2022; full year R&D expenses were $232.3 million, compared to $242.5 million in 2022[13]. - Research and development expenses for the year ended December 31, 2023, were $232,266 thousand, a decrease of 4.2% compared to $242,453 thousand in 2022[24]. Clinical Trials and Future Plans - ABBV-RGX-314 is being evaluated in nine ongoing clinical trials for wet AMD and diabetic retinopathy, with pivotal trials expected to support regulatory submissions in late 2025 to early 2026[4][6]. - In the AAVIATE trial, patients treated with ABBV-RGX-314 showed an 80% reduction in annualized injection rate, with 50% remaining injection-free at six months[6]. - REGENXBIO plans to file a Biologics License Application (BLA) for RGX-202 in 2024, using microdystrophin expression as a surrogate endpoint[11]. - The company expects to share updates on Duchenne and retinal disease programs starting in March 2024, with pivotal dose determination for RGX-202 anticipated in mid-2024[5][11]. - The company anticipates significant data readouts and milestones across all programs in 2024, marking a potential turning point in its journey[3]. General and Administrative Expenses - General and administrative expenses for Q4 2023 were $19.1 million, compared to $21.2 million in Q4 2022; full year G&A expenses were $88.5 million, up from $85.3 million in 2022[14].