Regenxbio 2025 Q1 Earnings Misses Targets as Net Income Swings 109.6%

Regenxbio reported a net income of $6.08 million for Q1 2025, reversing last year's $63.33 million loss. The company missed Wall Street's expectations, with revenues of $89 million falling short of the anticipated $110 million. Despite the earnings miss, Regenxbio maintains its financial guidance, expecting its cash reserves to support operations into the second half of 2026. The company's ongoing clinical programs and strategic developments were highlighted in their earnings call.

Revenue
Regenxbio experienced a significant revenue increase in Q1 2025, reaching $89.01 million, up from $15.62 million in Q1 2024. This growth was primarily driven by license and royalty revenue, which contributed $87.05 million, while service revenue added $1.96 million to the total.

Earnings/Net Income
Regenxbio returned to profitability in Q1 2025, with an EPS of $0.12, a significant improvement from a loss of $1.38 per share in Q1 2024. The net income turnaround, marked by a positive swing of 109.6%, reflects a favorable EPS outcome.

Post-Earnings Price Action Review
The strategy of buying Regenxbio stock when revenues miss expectations and holding for 30 days presents a high-risk, high-reward scenario. The biotechnology sector's inherent volatility means earnings misses can trigger sharp sell-offs. However, historical data show that keeping RGNX shares for 30 days after an earnings miss has, on average, yielded a positive return of 7.2% over the past year. This suggests that despite immediate negative reactions, patient investors might benefit from eventual market corrections, emphasizing the potential for gains in a volatile market.

CEO Commentary
“We have made tremendous progress towards delivering multiple commercial gene therapies, starting this year,” said Curran M. Simpson, President and Chief Executive Officer of REGENXBIO. He emphasized that the company’s late-stage assets show differentiation against standard care, positioning REGENXBIO to offer first- or best-in-class gene therapies for rare and retinal diseases. Simpson noted the advanced clinical programs, in-house commercial-ready manufacturing, and a strong balance sheet, which collectively equip the company to deliver transformative gene therapies to patients in need.

Guidance
REGENXBIO expects to share topline data for RGX-202 in the first half of 2026 and plans to submit a Biologics License Application (BLA) in mid-2026. The company anticipates commercial supply manufacturing for RGX-202 to begin in Q3 2025 and aims for a product launch in 2027. FDA acceptance of the BLA for clemidsogene lanparvovec (RGX-121) is expected in May 2025, with potential approval in the second half of 2025. Additionally, pivotal trial data for surabgene lomparvovec (ABBV-RGX-314) is expected in 2026.

Additional News
Regenxbio is actively participating in several upcoming investor conferences. The company will present at the BofA Securities Health Care Conference in Las Vegas on May 13, RBC Global Healthcare Conference in New York on May 20, and the UBS Spring Biotech Conference in New York on June 24, 2025. These events provide Regenxbio opportunities to showcase their strategic developments and engage with investors. Additionally, Regenxbio has announced presentations at the American Society of Gene & Cell Therapy 28th Annual Meeting in New Orleans from May 13-17, 2025. This meeting will highlight the company's advancements in gene therapy research, including late-stage clinical trial data for treatments targeting MPS II and Duchenne muscular dystrophy.