Precigen Expects Q1 Revenue Above $18M After $3.4M Q4 PAPZIMEOS Sales
Precigen saw net product sales of PAPZIMEOS reach $3.4 million in Q4 2025, with patient hub enrollment surpassing 300 and CMS assigning J-code J3404 effective April 1, 2026. The company expects Q1 2026 revenue to exceed $18 million and plans pediatric trials and a European EMA review.
1. Strong Q4 Results and J-code Assignment
Precigen generated net product sales of $3.4 million for PAPZIMEOS in Q4 2025, with shipments starting in November and patient hub enrollment surpassing 300. On April 1, 2026, CMS assigned J-code J3404 to streamline reimbursement and broaden access for RRP patients.
2. Market Adoption and Standard-of-Care Shift
Since its August 2025 launch, PAPZIMEOS has seen robust uptake as the first approved immunotherapy for recurrent respiratory papillomatosis, significantly reducing surgical interventions. A consensus paper by 16 leading physicians formally endorses PAPZIMEOS as the new first-line standard of care.
3. Commercial Outlook and Revenue Guidance
Leadership forecasts Q1 2026 revenue to exceed $18 million, driven by growing physician and patient demand and streamlined reimbursement. This marks a strategic shift from an R&D-focused biotech to a product revenue-generating company.
4. Pipeline Expansion and European Review
Precigen plans to initiate a pediatric RRP trial in Q4 2026 and a patient redosing study to enhance long-term outcomes. In November 2025, the EMA validated its Marketing Authorization Application, advancing prospects for European approval.