What Precigen (PGEN) Said on Its Q3 Earnings Call

Key Points

• PAPZIMEOS sales grew sharply, reaching $72.9 million in Q3, up about 37% from Q2. Precigen reported its second consecutive profitable quarter, with $35.8 million in net income and positive operating cash flow.
• More than 500 patients had started PAPZIMEOS treatment, and coverage agreements represented over 315 million U.S. lives. Precigen expects to compete with a newly approved rival by leveraging its clinical results and established reimbursement and treatment-site network.
• Precigen ended September with $51 million in cash and investments, generated $11.9 million in operating cash, and said it does not currently expect to need additional capital. Development plans include redosing and pediatric studies, with redosing data expected in 2028.

Precigen NASDAQ: PGEN reported $72.9 million in third-quarter 2026 sales of PAPZIMEOS, its treatment for adults with recurrent respiratory papillomatosis, as the company posted a second consecutive profitable quarter and generated positive cash flow ahead of its prior expectations.

Sales of PAPZIMEOS rose approximately 37% from the second quarter, contributing to total revenue of $74.1 million. Net income was $35.8 million for the quarter and $47.9 million for the nine months ended September 30, Chief Financial Officer Harry Thomasian said on the company’s earnings call.

The results come as Precigen prepares for competition in the market for recurrent respiratory papillomatosis, or RRP, an HPV-related disease historically managed through repeated surgeries. Executives said they had anticipated a competing therapy and believe PAPZIMEOS has established a commercial advantage since its U.S. approval in August 2025.

Sales growth and patient uptake

Chief Executive Officer Helen Sabzevari said PAPZIMEOS generated approximately $151 million in net product revenue from launch through the end of the third quarter. Quarterly sales increased from $21.5 million to approximately $53 million and then $72.9 million over the past three quarters, she said.

As of the call, well over 500 patients had begun treatment and more than 300 had completed it, according to Sabzevari. Chief Commercial Officer Phil Tennant said more than 600 patients had registered in the company’s patient-support hub, though that figure does not capture all patients receiving treatment because some institutions manage access and reimbursement independently.

Tennant said patients across the spectrum of disease severity were receiving the drug, including a significant proportion who had undergone fewer than three surgeries in the preceding 12 months. Precigen estimates that 27,000 adults in the United States live with RRP.

The company has secured coverage representing more than 315 million U.S. lives across commercial plans, Medicare and Medicaid, Tennant said. He added that a permanent reimbursement code effective April 1 helped support access. Asked about treatment timing and abandonment, Tennant said the time from prescription intent to treatment was consistent with rare-disease or oncology launches and described abandonment rates as relatively low, without providing specific figures.

Precigen did not provide fourth-quarter revenue guidance. Tennant said indicators including hub registrations, treatment-site activation and new patient starts supported management’s confidence in continued growth.

Competition and clinical data

Sabzevari noted the recent conditional approval of a competing RRP therapy and said Precigen had incorporated competition into its planning. During the question-and-answer session, an analyst said Inovio had indicated it would launch its competing product in the new year.

Precigen executives pointed to PAPZIMEOS’ clinical results, established reimbursement infrastructure and subcutaneous administration as reasons they expect it to remain competitive. Tennant said the company had moved beyond the foundational stage of its launch, while a new entrant would need to build payer access and treatment-site capabilities.

In PAPZIMEOS’ pivotal study, 18 of 35 patients, or 51%, required no surgeries during the 12 months after treatment completion, Sabzevari said. She also cited durable complete responses lasting up to five years and said the study reported no treatment-related adverse events above grade 2. Precigen did not present a head-to-head comparison with the competing therapy on the call.

Asked whether surgery was required during the dosing window, Sabzevari said it was not required and that a procedure to address residual disease was optional, depending on the physician’s assessment. She said Precigen expects to report follow-up data from treated patients when sufficient information is available, but did not give a date.

Cash position and development plans

Precigen ended September with $51 million in cash, cash equivalents and investments, up from $38.7 million at the end of June. Operating activities generated $11.9 million in cash during the quarter. The company also reported $96.5 million in trade receivables, which it expects to collect over the four months following quarter-end, based on customer payment terms.

Thomasian said Precigen has $100 million in outstanding debt and access to an additional $25 million under its debt facility. Considering its cash, receivables and available borrowing capacity, the company does not currently anticipate needing to raise additional capital, he said.

For PAPZIMEOS, Precigen is pursuing a redosing study for partial responders, pediatric development and expansion outside the United States. Sabzevari said the redosing trial is enrolling and the company expects to report data in 2028. Its European marketing application remains under review, and Precigen is evaluating potential partnerships outside the U.S. while also preparing for the possibility of operating independently.

Sabzevari also highlighted the FDA’s September platform technology designation for Precigen’s AdenoVerse platform. The company plans to present new phase II data for PRGN-2009, a candidate being studied in HPV-associated head and neck cancers, at an upcoming research and development day.

About Precigen (NASDAQ:PGEN)

Precigen, Inc is a clinical-stage biotechnology company focused on developing gene and cell therapies for cancer and serious diseases. The company uses its proprietary UltraCAR-T, AdenoVerse, and other gene-engineering platforms to design potential treatments intended to improve the targeting, persistence, and manufacturing of therapeutic cells and genetic medicines.

Precigen's pipeline has included PRGN-2012, an investigational immunotherapy based on a gorilla adenovector for recurrent respiratory papillomatosis, as well as PRGN-2001, an investigational HPV-targeted immunotherapy.

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