Release Date: March 19, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Precigen Inc (PGEN, Financial) is on the verge of commercializing its lead asset, PRGN-2012, with a PDUFA date set for August 27, 2025.
- PRGN-2012 has demonstrated a 51% complete response rate in clinical trials, with durable responses lasting up to 24 months.
- The company has built a dedicated GMP facility for in-house manufacturing, ensuring better control over production and costs.
- Precigen Inc (PGEN) has established a comprehensive commercialization strategy, including a partnership with a proven leader in rare disease launches.
- The company has a strong financial position, with cash reserves expected to support operations well into 2026.
Negative Points
- Precigen Inc (PGEN) reported a net loss of $126.2 million for 2024, an increase from the previous year's loss.
- The confirmatory trial for PRGN-2012 will not be completed by the PDUFA date, with results expected in 2026 or 2027.
- There is uncertainty regarding the FDA's pre-approval inspection timing, which is part of the regulatory process.
- The company faces challenges in ensuring payer access and pricing strategies for PRGN-2012, with potential utilization management by payers.
- Precigen Inc (PGEN) has yet to publish data from its Phase I study of PRGN-3006, with no specific timeline provided for its release.
Q & A Highlights
Q: Can you provide an update on interactions with the FDA regarding PRGN-2012 and your commercial launch plans?
A: Helen Sabzevari, CEO, stated that Precigen has maintained close interactions with the FDA, receiving priority review for their BLA submission. Phil Tennant, Chief Commercial Officer, mentioned that they plan to deploy a field force of 15 to 20 representatives targeting around 500 otolaryngologists concentrated in urban academic centers.
Q: Are there any updates on FDA pre-licensing inspections and labeling discussions?
A: Helen Sabzevari, CEO, noted that inspections are part of the regulatory process, especially for GMP facilities, and they remain in close alignment with the FDA as they approach the PDUFA date.
Q: How do you plan to address the anticipated demand for PRGN-2012 upon approval?
A: Phil Tennant, Chief Commercial Officer, expects a significant demand due to the lack of existing treatments. They plan to ensure timely access by deploying their team to reach as many patients as possible.
Q: What is the status of the confirmatory trial for PRGN-2012, and when can we expect data from the PRGN-3006 Phase I study?
A: Helen Sabzevari, CEO, stated that the confirmatory trial for PRGN-2012 has begun enrolling patients, with completion expected in 2026-2027. Updates on the PRGN-3006 data will be provided after discussions with the FDA.
Q: Can you elaborate on your pricing strategy and payer access for PRGN-2012?
A: Phil Tennant, Chief Commercial Officer, mentioned ongoing discussions with payers, aiming for a price point that reflects the drug's value. They are exploring value-based agreements but expect straightforward pricing aligned with payer expectations.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
