Precigen’s leadership team outlined rapid early commercialization progress for its recently approved therapy PAPZIMEOS during a Wednesday, March 25, 2026, update call covering fourth-quarter and full-year 2025 results. Management said the company has shifted from being primarily an R&D organization to a product revenue-generating commercial biotechnology company, driven by the launch of PAPZIMEOS as a first-line treatment for adult recurrent respiratory papillomatosis (RRP).
Early commercial ramp highlighted by Q1 revenue expectation
President and CEO Helen Sabzevari said PAPZIMEOS was granted early and full approval in August with a “broad label” for adult RRP, with no restriction tied to the number of prior surgeries. The company began commercial shipments in November, resulting in net product revenue of $3.4 million in Q4 2025, according to management.
Chief Financial Officer Harry Thomasian later clarified on the call that the more-than-$18 million figure refers only to PAPZIMEOS revenue and does not include collaboration or service revenue.
Launch indicators: patient hub growth, payer coverage, and utilization
Chief Commercial Officer Phil Tennant pointed to several “leading indicators” he said support a strong launch trajectory. He reported that the company’s patient support hub has continued to grow, with more than 200 patients in the hub by mid-January and “well over 300” as of the call date. Tennant emphasized, however, that the hub is not the only source of utilization, saying the company is also seeing patients treated outside of Precigen’s hub, including through large centers that operate their own systems.
On the reimbursement front, Tennant said covered lives increased from about 170 million in early January to approximately 215 million as of the call, spanning commercial insurance, Medicare, and Medicaid. He added that including Medicare and Medicaid fee-for-service brings total coverage to about 90% of insured lives in the U.S., which he characterized as strong progress for a rare disease drug.
Tennant also said PAPZIMEOS utilization is accelerating across the country, both at large institutions and in community practices, and that uptake is occurring “across a range of patient severities,” which he tied to the FDA label. Management cited a January expert consensus paper, sponsored by the RRP Foundation and published in Laryngoscope, that recommends PAPZIMEOS as the preferred first-line immunotherapy for adults with RRP.
Operational details: conversion timing, J-code, and ordering patterns
In Q&A, management addressed patient flow from hub enrollment to reimbursed treatment. Tennant said the company’s goal is to convert “the vast majority, if not all” hub patients to treatment, but timing can vary by patient and institution. He said once institutional readiness is established and payer coverage is in place, prior authorization should typically take “a matter of weeks,” though activation of integrated delivery networks (IDNs) can be a rate-limiting step.
Sabzevari added that the hub is a “continuous process,” with new patients entering as others move through preparation and treatment. She also said patients are advancing through the regimen, including receiving subsequent doses, and some who started last year have progressed through later treatments.
The company also expects a workflow benefit from a permanent J-code assignment effective April 1. Tennant said the J-code should simplify billing for providers and payers, reduce hesitancy among some payers, and improve administrative certainty and speed. He later noted it should streamline the process from benefit verification to institutional readiness to payer authorization, helping into Q2.
Asked about potential stocking effects behind the Q1 revenue expectation, Tennant said the company is seeing “very little stocking.” He said institutions can order one vial at a time or multiple vials, and while the company sees a mix of order sizes, orders are “predominantly” for single vials.
Management did not provide a specific count of prescribing physicians, but Tennant said the number of prescribers is rising consistently as the launch progresses.
Financial results reflect launch investment and non-cash items
Thomasian reported full-year 2025 revenue of $9.7 million, up from $3.8 million in 2024, attributing the increase primarily to the start of PAPZIMEOS product revenue, which totaled $3.4 million in 2025 due to the late-year launch.
He said R&D expense decreased by $11.7 million year over year, driven largely by a reduction in pipeline spending following a 2024 strategic prioritization. He also noted that after FDA approval, manufacturing-related costs began being classified into inventory rather than R&D expense, to be recognized later in cost of products and services when inventory is sold.
SG&A expense increased by $28.8 million year over year, which Thomasian said was primarily due to increased commercial activity for PAPZIMEOS.
The company reported a net loss attributable to common shareholders of $429.6 million, or $1.37 per share, which management said included $318.5 million of non-cash items related to preferred stock conversion and warrant reclassification that “will not recur in the future.”
Precigen ended 2025 with $100.4 million in cash, cash equivalents, and investments. Thomasian said the company believes that cash, along with anticipated PAPZIMEOS sales, will fund operations through cash-flow breakeven, which the company expects by the end of 2026.
In additional Q&A, Tennant said the company’s payer mix is tracking as previously communicated at roughly 60% to 65% commercial, with the remainder across Medicare, Medicaid, and other government channels. Thomasian said the company continues to anticipate a gross-to-net in the high teens to low 20s, and said results to date have been consistent with that range.
Pipeline and geographic expansion updates
Beyond the adult RRP launch, Sabzevari said Precigen is advancing plans for a pediatric RRP clinical trial for PAPZIMEOS and hopes to initiate it in the fourth quarter of the year. She also said the company has begun geographic expansion efforts, including validation of a Marketing Authorization Application to the EMA. Sabzevari noted positive feedback from European thought leaders and said the company will share updates when European authorities reach a decision.
Sabzevari also provided an update on PRGN-2009, describing it as an adenoviral program designed to target HPV 16 and HPV 18 and being studied in combination with pembrolizumab in multiple Phase II trials in head and neck and cervical cancers.
Management said it plans to provide full first-quarter results and additional commercial detail on its next earnings call in May.
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