Precigen Reports $3.4M in First PAPZIMEOS Sales, Secures Standard of Care Endorsement
Precigen reported $3.4 million in first commercial sales of PAPZIMEOS in Q4 2025 following FDA approval for recurrent respiratory papillomatosis. The drug has received standard of care endorsement from physician experts and now covers approximately 90% of insured U.S. lives. The company has $100.4 million in cash and is pursuing European regulatory approval.
Precigen has transitioned to a commercial-stage company with the U.S. approval of PAPZIMEOS, generating $3.4 million in net product revenue in the fourth quarter of 2025 from its first partial quarter of commercial sales. The drug, which received full FDA approval in August 2025 for the treatment of adults with recurrent respiratory papillomatosis (RRP), has been recommended as the new standard of care first-line treatment by an expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians.
The U.S. launch continues to build strong momentum, with a significant increase in demand in the first quarter of 2026. PAPZIMEOS patient hub enrollment has surpassed 300 registered patients, reflecting substantial patient and physician demand. Since full deployment of the field team in September 2025, 100% of target medical institutions have been engaged, with prescriptions and active treatment occurring nationwide across both major medical centers and community practices.
Patient access continues to expand, with private health plan coverage now estimated at approximately 215 million U.S. lives, including the significant majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid, with coverage collectively extending to approximately 90% of insured lives in the U.S. The Centers for Medicare and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026, which will streamline the claims process and facilitate broader patient access.
Internationally, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP has been validated by the European Medicines Agency and is under review. The review by the EMA's Committee for Medicinal Products for Human Use is expected to last approximately 210 days, followed by an additional two months for a decision from the European Commission.
The company has initiated an open-label redosing study to evaluate retreatment efficacy of zopapogene imadenovec in adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for adults with RRP, a rare and potentially life-threatening disease of the respiratory tract caused by chronic HPV 6 or HPV 11 infection that can lead to severe voice impairment, airway obstruction and recurrent pneumonias.
Cash, cash equivalents, and investments totaled $100.4 million as of December 31, 2025, which is expected to fund the Company's operations to cash flow break-even. The stock has shown significant movement, with a one-year total shareholder return of 139.39% following the U.S. approval, EMA validation, and physician consensus paper endorsement.