REGENXBIO(US:RGNX)2023-05-03 20:16Financial Performance - Total revenues for the three months ended March 31, 2023, were $19.1 million, down 13.9% from $22.2 million in the same period of 2022[19]. - The net loss for the first quarter of 2023 was $66.7 million, compared to a net loss of $76.7 million for the same period in 2022, reflecting an improvement of approximately 13.4%[19]. - The company reported a comprehensive loss of $62.9 million for Q1 2023, compared to a comprehensive loss of $86.1 million in Q1 2022, showing a reduction of approximately 26.9%[19]. - Total revenues for Q1 2023 were $19.1 million, a decrease of $3.1 million (approximately 14%) from $22.2 million in Q1 2022[126]. - The net loss for Q1 2023 was $66.7 million, an improvement of $10.0 million compared to a net loss of $76.7 million in Q1 2022[126]. Assets and Cash Position - As of March 31, 2023, REGENXBIO Inc. reported total assets of $747.8 million, a decrease from $833.3 million as of December 31, 2022, representing a decline of approximately 10.3%[18]. - Cash, cash equivalents, and marketable securities totaled $473.5 million as of March 31, 2023, which is expected to fund operations for at least the next 12 months[29]. - The total stockholders' equity decreased to $465.1 million as of March 31, 2023, down from $516.2 million at the end of 2022, a decline of approximately 9.9%[18]. - As of March 31, 2023, cash and cash equivalents totaled $70,091,000, down from $191,873,000 as of March 31, 2022, representing a decrease of approximately 63.5%[35]. - Total cash and cash equivalents and restricted cash amounted to $72,121,000 as of March 31, 2023, compared to $193,903,000 in the previous year, indicating a decline of about 62.8%[35]. Research and Development - Research and development expenses increased to $58.5 million in Q1 2023, up from $55.6 million in Q1 2022, indicating a rise of about 3.4%[19]. - Research and development expenses for Q1 2023 totaled $58.5 million, compared to $55.6 million in Q1 2022, reflecting ongoing investment in product development[119]. - Direct expenses for ABBV-RGX-314 in Q1 2023 were $5.0 million, down from $7.5 million in Q1 2022, indicating a reduction in spending[119]. - The Company has developed ABBV-RGX-314, currently in nine ongoing clinical trials for the treatment of wet AMD and diabetic retinopathy, with pivotal trials expected to expand enrollment to 540 and 660 patients respectively[96][97]. - Enrollment in Cohorts 4 and 5 of the ALTITUDE® trial for ABBV-RGX-314 has been completed, with interim data expected in the second half of 2023[102]. Revenue Sources - Zolgensma royalties for Q1 2023 were $16,125,000, down 25.3% from $21,539,000 in Q1 2022[59]. - Total license and royalty revenue for Q1 2023 was $19,138,000, a decrease of 13.4% compared to $22,218,000 in Q1 2022[59]. - License and royalty revenue decreased by $3.1 million, primarily due to a $5.4 million decline in Zolgensma royalty revenues, which fell from $21.5 million in Q1 2022 to $16.1 million in Q1 2023[127]. - Revenue from commercial sales of Zolgensma and royalties paid to HCR are key financial metrics for the company[145]. Liabilities and Expenses - The accumulated deficit reached $508.2 million as of March 31, 2023, increasing from $441.6 million at the end of 2022[29]. - The company had a net cash used in operating activities of $80.9 million for Q1 2023, compared to $55.9 million for Q1 2022, indicating an increase in cash outflow[24]. - The allowance for credit losses increased to $4.3 million as of March 31, 2023, from $4.2 million at the end of 2022, related solely to accounts receivable from Abeona Therapeutics[66]. - Stock-based compensation expense totaled $11,206 thousand for the three months ended March 31, 2023, an increase from $10,800 thousand in 2022[81]. - The Company recorded accrued expenses and other current liabilities of $31,709 thousand as of March 31, 2023, down from $46,794 thousand at December 31, 2022[90]. Collaborations and Agreements - The Company entered into a collaboration agreement with AbbVie, receiving an upfront fee of $370 million and potential milestone payments totaling up to $1.38 billion[75]. - The Company recorded $18.2 million due from AbbVie for net reimbursement of costs incurred under the collaboration agreement as of March 31, 2023[77]. - The collaboration agreement with AbbVie for ABBV-RGX-314 may significantly impact future revenues and operating expenses[114]. Market and Regulatory Considerations - The pivotal trials are expected to support regulatory submissions to the FDA and EMA in late 2025 through the first half of 2026[97]. - RGX-202 received Fast Track designation from the FDA in April 2023 for the treatment of Duchenne muscular dystrophy, aimed at expediting its development[103]. - The CAMPSIITE™ trial for RGX-121 is ongoing, with enrollment of 10 patients expected to complete in the first half of 2023 to support a BLA filing in 2024[104]. - Initial data from the CAMPSIITE™ trial showed RGX-121 was well-tolerated, with significant reductions in CSF glycosaminoglycans observed[105]. Internal Controls and Risk Management - As of March 31, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[149]. - There were no changes in internal control over financial reporting that materially affected the company during the quarter ended March 31, 2023[150]. - The company does not believe it is currently party to any pending legal actions that could materially affect its business or financial condition[154]. - There have been no material changes to the company's exposure to market risk during the three months ended March 31, 2023[147].