Regenxbio | 8-K: FY2025 Q2 Revenue Misses Estimate at USD 21.36 M

Revenue: As of FY2025 Q2, the actual value is USD 21.36 M, missing the estimate of USD 40.87 M.

EPS: As of FY2025 Q2, the actual value is USD -1.38, missing the estimate of USD -0.8965.

EBIT: As of FY2025 Q2, the actual value is USD -63.28 M, missing the estimate of USD -42.27 M.

Segment Revenue

• Total Revenues: $21.4 million for the three months ended June 30, 2025, compared to $22.3 million for the same period in 2024. The decrease was primarily due to a reduction in Zolgensma royalties, which fell from $21.8 million in Q2 2024 to $18.4 million in Q2 2025, partially offset by an increase in service revenues, notably $2.7 million from development service revenue under the Nippon Shinyaku partnership.

Operational Metrics

• Net Loss: $70.9 million for the three months ended June 30, 2025, compared to $53.0 million for the same period in 2024.
• Research and Development Expenses: $59.5 million for the three months ended June 30, 2025, up from $48.9 million for the same period in 2024, primarily due to manufacturing-related expenses and clinical trial costs for sura-vec and RGX-202 pivotal trials.
• General and Administrative Expenses: $19.9 million for the three months ended June 30, 2025, compared to $18.9 million for the same period in 2024, driven by personnel-related costs and consulting expenses.

Cash Flow

• Cash Position: Cash, cash equivalents, and marketable securities totaled $363.6 million as of June 30, 2025, compared to $244.9 million as of December 31, 2024. The increase was mainly due to a $110.0 million upfront payment from the Nippon Shinyaku partnership and $144.5 million from royalty monetization with HCRx.

Unique Metrics

• Royalty Monetization: REGENXBIO closed a non-dilutive, limited recourse royalty bond agreement of up to $250 million with Healthcare Royalty (HCRx), receiving $150 million at closing and eligible for an additional $100 million in two separate $50 million tranches.

Outlook / Guidance

• REGENXBIO expects its cash balance of $363.6 million as of June 30, 2025, to fund operations into early 2027, excluding potential payments from partners or licensees upon achieving development or regulatory milestones, or upon approval or commercialization of product candidates.
• REGENXBIO plans to advance its DR program to late-stage development, aiming to provide a transformative treatment for diabetic retinopathy. The collaboration with AbbVie includes an updated milestone structure, reflecting AbbVie’s continued investment in the sura-vec program.
• AbbVie will pay REGENXBIO $100 million upon the first patient dosed in the Phase IIb/III trial for DR SCS treatment and an additional $100 million upon the first patient dosed in the subsequent Phase III trial.