Regenxbio (RGNX) investor relations material

Commercial and financial highlights

• DUPIXENT achieved $17.8 billion in sales last year, up 32% year-over-year, with continued growth across all nine FDA-approved indications and strong launches in COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis.

• EYLEA HD sales reached $506 million last quarter, up 66% year-over-year, with market share expected to expand due to recent label enhancements and anticipated prefilled syringe approval.

• EYLEA is expected to see sequential double-digit declines due to biosimilar competition, while conversion efforts focus on moving patients to EYLEA HD.

• LYNOZYFIC launched in late-line myeloma with early positive uptake and aims to expand into earlier lines, targeting a significant market opportunity.

• Obesity pipeline includes olatorepatide, showing 19% weight loss in pivotal China data, with US phase III trials planned to start later this year.

Product and pipeline developments

• DUPIXENT maintains a strong competitive position in atopic dermatitis, with life cycle management focused on long-acting IL-4 and IL-13 antibodies and a bispecific targeting both pathways.

• EYLEA HD is positioned as the most flexible anti-VEGF product, with prefilled syringe approval expected to further boost adoption.

• LYNOZYFIC is expanding from fourth-line to earlier lines in myeloma, with best-in-class activity observed in ongoing studies.

• LAG-3 antibody fianlimab plus LIBTAYO is in a pivotal trial for metastatic melanoma, with a near-term readout expected and potential for practice-changing results if median PFS reaches low to mid-teens.

• Geographic atrophy and PNH programs have key readouts expected in the second half of this year, while Factor XI pivotal data is anticipated in 2025.

Strategic outlook and catalysts

• Near-term catalysts include pivotal data for fianlimab plus LIBTAYO in melanoma, geographic atrophy, and PNH.

• Obesity program milestones include the start of phase III trials and co-formulation with PRALUENT to address both weight loss and LDL reduction.

• LYNOZYFIC aims for broader market penetration as clinical data supports earlier line use, with significant market expansion potential.

• Factor XI program is progressing, with pivotal VTE study data expected in the first half of next year.

• Competitive landscape developments, including biosimilar entries and competitor readouts, are being closely monitored for strategic adjustments.