Precigen (NASDAQ:PGEN) executives said the company is seeing a rapid ramp in early commercial demand for PAPZIMEOS, its newly approved therapy for adult recurrent respiratory papillomatosis (RRP), as management discussed fourth-quarter and full-year 2025 results and provided a near-term update on first-quarter 2026 sales trends.
PAPZIMEOS launch ramps from partial Q4 to first full quarter in Q1
President and CEO Helen Sabzevari said PAPZIMEOS received “early and full approval” in August and is now positioned as the standard-of-care first-line treatment for adults with RRP. With commercial shipments beginning in November, the company reported Q4 2025 net product revenue of $3.4 million.
During Q&A, CFO Harry Thomasian Jr. clarified that the “exceed $18 million” expectation refers to PAPZIMEOS product revenue only, excluding other revenue sources.
Company highlights broad FDA label and physician endorsement
Sabzevari attributed early uptake to what she described as transformative clinical data and a broad FDA label for adult RRP with “no restriction based on the number of prior surgeries.” She said the pivotal study was powered by a prospectively defined primary endpoint of complete response rate and emphasized the durability of responses with more than three years of follow-up.
She also pointed to a January publication of an expert consensus paper sponsored by the RRP Foundation and authored by 16 U.S. physicians, published in Laryngoscope. According to Sabzevari and Chief Commercial Officer Phil Tennant, the paper recommends PAPZIMEOS as the first immunotherapy and the preferred first-line treatment for adults with RRP.
Early commercial indicators: patient hub growth, payer coverage, and community adoption
Tennant said the company’s Q4 efforts focused on building a platform for accelerated uptake, including payer coverage expansion and account activation. He provided several launch indicators:
- Patient support hub enrollment: Tennant said the company had over 200 patients in its support hub in mid-January and that the total is now “well over 300.” He described the growth as reflecting pent-up demand.
- Payer coverage: Tennant said covered lives increased from about 170 million in early January to about 215 million currently, including “nearly all major payers across commercial, Medicare, and Medicaid.” He added that including Medicare and Medicaid fee-for-service brings coverage to roughly 90% of insured lives in the U.S.
- Utilization breadth: Tennant said utilization is accelerating at large institutions, academic centers, and community practices, and across a range of disease severities, which he said aligns with the broad label.
On community uptake, Tennant said the company expected community practices to be part of the strategy and was encouraged by what he called “extreme interest” soon after approval. Another executive, Rutul, added that Precigen has implemented end-to-end cold-chain logistics and provides options for community practices that may lack cold storage, including low-cost solutions and “just-in-time shipments” to avoid storage needs.
Reimbursement workflow and J-code expected to streamline access
Analysts asked about the flow of patients from the company’s hub to reimbursed treatment. Tennant said the Precigen Support Hub does not capture the full picture because patients are also treated through other channels, including hubs at large centers. He said the company’s goal is to convert “the vast majority, if not all” hub patients onto treatment, but timing can vary by institution and patient.
Tennant said once institutional activation is in place, prior authorization “should only take a matter of weeks,” with institutional readiness sometimes being the limiting factor. Sabzevari added that hub enrollment is continuous as patients move through treatment while new patients enter.
Management also repeatedly highlighted the assignment of a permanent J-code effective April 1, which Tennant said should simplify provider workflow and billing, increase certainty for payers, and improve speed of processing into Q2.
Regarding ordering patterns, Tennant said he has seen “very little stocking” by institutions. He said orders can range from one to four vials at a time, with most orders being for single vials.
Financial results and cash runway
Thomasian reported 2025 revenue of $9.7 million, up from $3.8 million in 2024, driven primarily by the start of PAPZIMEOS product revenue, which totaled $3.4 million in 2025 following the first recorded sale in November.
On expenses, he said:
- R&D expense decreased $11.7 million (22.1%) year over year, primarily due to a $9.4 million reduction tied to the pipeline prioritization announced in 2024. He also noted that after FDA approval, manufacturing-related costs for PAPZIMEOS began being classified to inventory rather than R&D.
- SG&A expense increased $28.8 million (69.8%), primarily due to a $27.3 million increase related to PAPZIMEOS commercial activities.
Precigen posted a net loss attributable to common shareholders of $429.6 million, or $1.37 per share, for 2025. Thomasian said results included two large non-cash items related to preferred stock and warrants totaling $318.5 million, or $1.02 per share, and said these items will not recur because the preferred stock was converted to common shares and the warrants were reclassified to equity.
The company ended 2025 with $100.4 million in cash, equivalents, and investments. Thomasian said management believes existing funds plus anticipated PAPZIMEOS sales will fund operations through cash-flow breakeven, which the company currently expects by the end of 2026.
In Q&A, Tennant said the payer mix is tracking as expected at about 60% to 65% commercial with the remainder in government channels. Thomasian reiterated the company expects gross-to-net in the high teens to low 20% range and said it has been consistent with revenue recognized to date.
Beyond the adult RRP launch, Sabzevari said Precigen is advancing plans to initiate a pediatric RRP clinical trial for PAPZIMEOS, which the company hopes to start in Q4 of this year. She also said the company is pursuing geographic expansion, noting validation of a marketing authorization application to the EMA for PAPZIMEOS and reporting positive feedback from European thought leaders. In addition, she said the company plans to sponsor activities around the third annual RRP Awareness Day in June.
Sabzevari also briefly discussed PRGN-2009, a program using the same adenovirus technology designed to target HPV 16 and 18, which is being studied with pembrolizumab in multiple Phase 2 trials in head and neck and cervical cancer.
Management said it expects to provide final Q1 results and additional commercial updates during a call in May.
About Precigen (NASDAQ:PGEN)
Precigen, Inc (NASDAQ: PGEN) is a biotechnology company focused on the discovery, development and commercialization of genetic medicines. The company leverages proprietary gene and cell therapy platforms to design targeted therapies for oncology, infectious diseases and rare conditions. Precigen’s approach combines synthetic biology, immuno-oncology and microbiome engineering to create precision treatments intended to enhance efficacy while minimizing off-target effects.
The centerpiece of Precigen’s technology is its OmniCAR platform, which enables the rapid generation of adaptable chimeric antigen receptor (CAR) T-cell products.
