Precigen (NASDAQ:PGEN) reported a sharp increase in second-quarter revenue from its PAPZIMEOS launch, with the company reaching quarterly profitability less than a year after the therapy’s August 2025 FDA approval for adults with recurrent respiratory papillomatosis, or RRP.
PAPZIMEOS revenue totaled $53.1 million in the second quarter, up from $21.6 million in the first quarter. Total revenue was $55 million. Chief Executive Officer Helen Sabzevari said the result reflected broadening patient access, physician adoption and use at both major medical centers and community practices.
PAPZIMEOS Adoption and Access
The company said PAPZIMEOS is the first and only approved therapy for adult RRP and that its FDA label does not require patients to undergo a minimum number of prior surgeries before treatment. Sabzevari said physicians are using the drug across a broad range of patients, rather than only in the most severe cases.
Precigen Chief Commercial Officer Phil Tennant said the company’s patient-support hub had registered well over 500 patients as of the call. However, he noted that hub data do not capture all treated patients because a meaningful number of patients are being treated at institutions that do not use the hub.
The company said it had treated more than 200 patients with at least one PAPZIMEOS dose, while more than 100 patients had completed the four-treatment course. PAPZIMEOS is administered as a four-injection regimen over 12 weeks. Tennant said some patient doses carry into subsequent quarters, but that new demand is expected to drive the bulk of revenue over the next several quarters.
Commercial and government payer coverage reached approximately 315 million lives after the addition of about 18 million covered lives during the quarter, according to Tennant. He said the coverage represents nearly all potential covered lives in the U.S. market.
Management also cited the April 1 implementation of a permanent J-code as an important factor in adoption. Tennant said the code provides a standard reimbursement pathway and has helped bring additional institutions on board, including some that had been waiting for the code before beginning patient identification and treatment.
Precigen initially identified approximately 500 institutions that it said cover more than 90% of the RRP patient population, including about 100 large hospital systems responsible for more than 80% of patients. Tennant did not disclose how many of those accounts have ordered PAPZIMEOS, but said activated accounts are becoming repeat users.
Durability, Exclusivity and Development Plans
Sabzevari highlighted long-term PAPZIMEOS data presented at ASCO, stating that as of an April 30 cutoff, 83% of patients in ongoing complete response remained surgery-free beyond three years. Some patients were beyond four years without surgery, she said. Sabzevari added that these complete responders had not received further RRP treatment after PAPZIMEOS.
The FDA granted PAPZIMEOS seven years of market exclusivity for adult RRP, extending into August 2032, the company said.
Precigen is also evaluating PAPZIMEOS redosing in an actively enrolling clinical trial and remains on track to begin a pediatric PAPZIMEOS trial this year. Its marketing authorization application is under review by the European Medicines Agency, and the therapy has received Orphan Drug Designation from the European Commission.
In its broader pipeline, the company said PRGN-2009 is being studied in multiple Phase II trials in combination with pembrolizumab for head and neck cancer and cervical cancer. The investigational immunotherapy is designed to target tumor cells associated with HPV16 and HPV18. Sabzevari said Precigen expects to provide updated head and neck cancer data later this year.
Financial Results and Outlook
Precigen reported a gross margin of $52.2 million, or 95%, during the second quarter, as cost of products and services totaled $2.8 million. Chief Financial Officer Harry Thomasian said the margin reflected the sale of pre-launch inventory. Following the anticipated sale of the remaining pre-launch inventory in the third quarter, the company expects PAPZIMEOS gross margins to stabilize in the high-80% to low-90% range.
- Research and development expense was $7.3 million, down $4.2 million from the prior-year quarter.
- Selling, general and administrative expense was $22.2 million, up $6.1 million year over year, driven largely by PAPZIMEOS commercial activities.
- Operating income was $22.6 million.
- Net income was $20.1 million, or $0.05 per diluted share.
At June 30, Precigen had $38.7 million in cash equivalents and investments, as well as $71.9 million in trade accounts receivable. Thomasian said the company expects to collect those receivables over the four months following quarter-end based on customer payment terms.
Management reiterated that its cash equivalents and investments, together with expected collection of PAPZIMEOS receivables, are expected to fund operations through cash-flow breakeven by the end of 2026. While executives said PAPZIMEOS growth is continuing into the third quarter, they did not provide a specific revenue forecast, noting that growth rates typically diminish over time as a launch matures.
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.
