PRECIGEN, INC. Q4 FY2025 earnings call

• Papzimia received full FDA approval with broad label for adult RRP with no prior surgery restrictions, driven by transformative clinical data including unmatched efficacy. • Commenced commercial sales in Q4 2025, transitioning from R&D to product revenue-generating commercial biotech. • Q1 2026 revenues expected to exceed $18 million due to strong momentum in commercial activity. • Actively advancing pediatric RRP clinical trial to commence in Q4 2026, and geographic expansion with EMA marketing authorization application for Papsenia. • Sponsoring RRP Awareness Day in June to spread global awareness. • PRGN-2009 program utilizing AdenoVerse technology for HPV 16 and 18, in Phase 2 clinical trials with pembro.

For the year ended 12/31/2025, revenue totaled $9.7 million versus $3.2 million in 2024, an increase of $5.8 million or 149%, primarily driven by the commencement of Papsimius' product revenue which totaled $3.4 million in 2025. Q4 2025 net product revenue was $3.4 million with shipments commencing in November. Based on commercial activity to date, expected Q1 2026 revenues to exceed $18 million. Research and development expenses decreased by $11.7 million, or 22.1%, due to strategic pipeline prioritization. Selling, general, and administrative expenses increased by $28.8 million, or 69.8%, due to costs related to Papsimius' commercial activities. Net loss attributable to common shareholders was $429.6 million, or $1.37 per share, with noncash items related to preferred stock-related warrants. Ended the year with $100.4 million of cash, cash equivalents, and investments.

• Expect revenues in Q1 2026 to exceed $18 million based on commercial activity to date. • Do not plan regular revenue guidance but provided Q1 2026 guidance as it's first full quarter of Papsimius commercial sales. • Believe current funds plus anticipated cash from Papsimius sales will fund operations through cash flow breakeven by 2026. • Expect trends of launch to continue assisted by permanent J-code from April 1 and continued durability of response.

Q: Can you help us think about how you guys are planning the flow of patients from the hub to receiving reimbursed drug? Do you expect the majority of the 300 patients to ultimately get reimbursed treatment? And then what kind of time frame, understanding it's still early in the launch? And then second question, are you now at the point where patients are starting to get their second dose in the treatment regimen? And can you give us any color about, like, you know, the proportion of patients that are that are eligible or are getting the second treatment?

A: Helen Sabzevari defers to Phil Tennant. Phil Tennant says patients are being converted from the hub, conversion speed varies by patient and institution, prior authorization with payers takes weeks, and patients are moving through treatments.

Q: Having said that, just trying to understand a little bit more of of the of the nuances. Especially with the you know, with with the flow of patients. Through the through the hub into the into the conversion And, also, how is the J-code you know, how how is that helping out in terms of adding more patients? You know, not only in the in the the in in this quarter, but also getting them up for the next quarter. I would think that it takes a certain amount of time between the patient coming into the into the clinic and then getting the the therapy.

A: Phil Tennant says J-code simplifies workflow and billing process, streamlining administrative process and increasing certainty and speed. Helen Sabzevari adds on the importance of payers' approval and the number of payers covered contributing to the trajectory.

Q: Thinking about the MAA and also the European potentially, European launch. You know, in terms of your discussions with the with the regulatory body there, you know, where are things now? And do you do you expect the approval you know, in the '27, or should we assume it is going to be later? And also, in terms of of of the launch, you know, so should we send the Phil back to Europe and, you know, get that launch going over there?

A: Helen Sabzevari says EMA application is under review, and they look forward to the European authorities' decision, will share with market when communicated.

Q: Can you clarify on the 18,000,000 revenue guidance here? Is the 18,000,000 guidance inclusive of collaboration and service revenues? In addition of Pepsi news product revenue. It's 18 only referring to Pepsi meals product revenue? And then maybe just on top of that, can you talk about the number of doctors that are now actively prescribing a Pepsi And how effective is the conversion rate from your patient hub compared to the academic hub?

A: Harry Thomasian says $18 million includes only Papsimius product revenue. Phil Tennant talks about little stocking, increasing number of prescribers, and conversion from both hub and non-hub patients.

Q: You called out community uptake as a pleasant surprise, like I know it is early, but as the community channel develops, what have you learned about what different differentiates community sites that become repeat prescribers versus those that adopt more of a wait and see approach? And then follow-up on gross to net cadence for the balance of the year?

A: Phil Tennant says community is a significant contributor with low cost logistics and multiple solutions. Rutul Shah adds on end-to-end cold chain validated logistics and solutions for community practices. Phil Tennant talks about payer mix being about 60-65% commercial. Harry Thomasian says gross to net will be in high teens, low twenties.