PRECIGEN, INC. Q3 FY2025 earnings call

• Papcemias approval in August is a landmark for RRP, addressing the root cause by targeting HPV 6 and 11 infected cells, with 51% of patients achieving complete response and 86% reducing surgical burden. - Commercial progress: Sales team of 18 key account managers deployed, 90% of target institutions engaged, shipping to prescribers, over 100 patients registered in hub, payer coverage advancing. - Manufacturing: Dedicated in-house cGMP facility for Papcemias drug substance manufacturing, operational since prior to approval, supporting current and future demand. - Financials: Expected cash and Papcemias revenues to fund operations to cash breakeven, gross to net revenue adjustment anticipated in high teens to low 20%.

The key segment is Papcemias, the first and only treatment for adults with recurrent respiratory papillomatosis (RRP). Financials: As of September 30, 2025, cash, cash equivalents, and investments were $123.6 million. Inventory was approximately $3 million. SG&A costs increased by ~$14 million in the quarter due to Papcemias launch. Net loss included non-cash items like change in warrant liability and deemed dividend from preferred share conversion.

• Expect cash flow breakeven with current cash balance and projected revenues from Papcemias. - Anticipate gross to net revenue adjustment in the high teens to low 20%, consistent with industry peers.

No detailed discussion of specific risks in the transcript, but general risks related to clinical trial outcomes and market adoption could exist.

Q: Any color on patients receiving reimbursement approvals or being dosed with Papcemias, and cadence of pull-through from registered patients.

A: Started shipping Papcemias to institutions, payer coverage advancing; patients in hub are waiting for benefit verification and prior authorization, with pull-through expected to pick up in Q4.

Q: Assumptions for cash flow breakeven.

A: Not guiding on revenue, but expect to be cash flow breakeven by 2026.

Q: Duration of pent-up demand for Papcemias.

A: Lasts for quite a while, similar to rare disease uptake, and broad label covers all adult RRP.

Q: How Papcemias revenue is recorded.

A: Recognize revenue when title transfers to entities like specialty pharmacies or hospitals upon receipt.

Q: Size and trajectory of registered patient population.

A: Rapid recruitment, high urgency, vast majority of registered patients expected to receive Papcemias over time.