Precigen (PGEN) Q4 2025 earnings summary

Executive summary

• Achieved commercial stage with FDA approval and US launch of PAPZIMEOS for adult RRP, transitioning from R&D to revenue generation.

• PAPZIMEOS recognized as the new standard of care, with unmatched efficacy, strong physician and patient demand, and broad payer coverage in the US.

• Marketing Authorization Application for PAPZIMEOS under review by the EMA, with orphan drug designation and strong European interest.

• Initiated open-label redosing study for PAPZIMEOS and advanced PRGN-2009 immunotherapy clinical trials for HPV-associated cancers.

• Strong initial uptake and enthusiasm from patients and physicians, with rapid expansion in payer coverage and institutional activation.

Financial highlights

• 2025 revenue totaled $9.7 million, up 149% from $3.8 million in 2024, driven by PAPZIMEOS launch.

• Q4 2025 net product revenue was $3.4 million, with shipments starting in November.

• Q1 2026 revenue expected to exceed $18 million, reflecting robust sales ramp.

• Net loss attributable to common shareholders was $429.6 million or $1.37 per share for 2025, including $318.5 million in non-cash items from preferred stock and warrants.

• Ended 2025 with $100.4 million in cash equivalents and investments.

Outlook and guidance

• No regular revenue guidance planned, but Q1 2026 revenue expected to exceed $18 million.

• Anticipated cash and PAPZIMEOS sales expected to fund operations through cash flow breakeven by end of 2026.

• Continued expansion expected with permanent J-code from April, further streamlining reimbursement.

• EMA application for PAPZIMEOS under review, with strong interest from European physicians.

• Continued strong commercial momentum for PAPZIMEOS anticipated in 2026, with expanded patient access and payer coverage.