Precigen Q2 Earnings Call Highlights

PAPZIMEOS drove a major commercial acceleration: Second-quarter revenue reached $53.1 million, up more than 145% from the first quarter, helping Precigen achieve $20.1 million in net income and $22.6 million in operating income. Adoption and reimbursement expanded: More than 200 patients had received treatment, over 100 completed the four-dose regimen, and payer coverage reached approximately 315 million U.S. lives. Precigen said the permanent J-code is helping additional institutions begin using the therapy. Management expects continued growth and pipeline expansion: PAPZIMEOS has FDA market exclusivity through August 2032, while trials are evaluating redosing and pediatric use. The company expects its cash, investments and receivables to fund operations through cash-flow breakeven by the end of 2026.

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.

“Q2 represented exceptional growth from Q1,” Sabzevari said, adding that PAPZIMEOS revenue increased by more than 145% sequentially. She said the product’s launch-to-date revenue exceeded $78 million at the end of the quarter.

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.

Sabzevari highlighted long-term PAPZIMEOS data presented at ASCO, stating...