What is the revenue and EPS growth rate for Precigen year over year?

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Did Precigen beat or miss consensus estimates last quarter?

- **Q1 Revenue Surges**: Exceeds $18 million, up from $3.4 million in Q4 2025, driven by Papzimeos launch.
- **Payer Coverage**: 90% of U.S. insured lives covered, with J-code streamlining access.
- **European Expansion**: MAA under review, targeting 2026 approval.
- **Financial Health**: $100.4 million cash on hand, on track for 2026 breakeven.

**【CEO Summary Section】**
- **Revenue Growth**: Q4 2025 net product revenue was $3.4 million, with Q1 2026 expected to exceed $18 million, driven by Papzimeos commercial launch.
- **FDA Approval and Expert Endorsement**: Papzimeos received full FDA approval for adult RRP, supported by unmatched efficacy data and a landmark expert consensus paper positioning it as the first-line treatment.
- **Pipeline Updates**: Planning to initiate a pediatric RRP clinical trial in Q4 2026 and advancing PRGN-2009 for HPV-associated cancers.

**【CCO Commercial Update】**
- **Patient Momentum**: Over 300 patients in the Precigen Support Hub as of March 2026, with 90% of U.S. insured lives covered by payers.
- **J-Code Impact**: Permanent J-code effective April 2026 will streamline billing and accelerate patient access.
- **Community Uptake**: Significant interest from community practices, supported by low-cost logistics solutions.

**【CFO Financial Commentary】**
- **2025 Financials**: Total revenue $9.7 million (149% YoY growth), net loss $429.6 million due to non-cash items, ending with $100.4 million in cash.
- **Cost Management**: R&D expenses decreased 22.1%, while SG&A increased 69.8% due to commercial activities.
- **2026 Outlook**: Anticipate cash flow breakeven by year-end, driven by Papzimeos sales.

**【Q&A Highlights】**
- **Patient Conversion**: Over 300 patients in the hub, with most expected to convert to treatment; J-code will accelerate this process.
- **European Launch**: MAA under review; anticipate regulatory decision in 2026.
- **Gross-to-Net Margin**: Expected to remain in the high teens to low 20s percent range.


Precigen Inc (PGEN) Q4 2025 Earnings Call Transcript

- **Breakthrough Therapy Launched**: PAPZIMEOS approved for all adult RRP patients with 51% complete response rate and 3+ years surgery-free durability.
- **Commercial Momentum**: 90% of target institutions engaged, 80M+ lives covered, $123.6M cash to fund 2026 breakeven.
- **Growth Catalysts**: European expansion underway, pediatric trials planned, redosing supported by clinical data.
- **Financial Discipline**: 15-20% gross margin, non-cash losses resolved, no recurring dilution.

**【CEO Summary Section】**
- PAPZIMEOS received FDA approval for all adult RRP patients, driven by 51% complete response rate and 86% reduction in surgeries.
- 15-year development timeline resulted in unmatched durability (3+ years without surgery) and safety profile comparable to flu vaccines.
- EMA submission underway for European expansion, with pediatric trials planned.

**【CFO Financial Commentary】**
- $123.6M cash on hand, with projected cash flow breakeven by end-2026.
- Q3 2025 net loss of $1.06M (non-cash items: $0.95M deemed dividend/warrant liability).
- Gross-to-net revenue adjustment expected at 15-20%, consistent with biotech peers.

**【Q&A Highlights】**
- 90% of target institutions engaged, 100+ patients registered in launch hub.
- Payer coverage exceeds 80M lives, including Medicare/Medicaid.
- Revenue recognized upon shipment, not injection.
- Redosing potential supported by durability data and physician discretion.
- Strong demand from both academic centers and community practices.


Precigen, Inc. (PGEN) Q3 2025 Earnings Call Transcript

- **FDA Fast Track**: PRGN-2012 BLA under priority review with August 2025 PDUFA date; no advisory committee meeting.
- **Clinical Success**: 51% complete response rate, 24-month median durability, 86% surgery reduction; no safety concerns.
- **Commercial Readiness**: 15-20 field reps targeting 500 otolaryngologists; $97.9M cash runway supports 2025 launch.
- **Market Opportunity**: 27,000 U.S. RRP patients; payers recognize value of non-surgical treatment for irreversible damage.

**【CEO Opening Remarks】**
- Submitted BLA for PRGN-2012 in recurrent respiratory papillomatosis (RRP) with FDA acceptance and priority review (PDUFA date: August 27, 2025). No advisory committee meeting planned.
- Pivotal trial met primary endpoint with 51% complete response rate (median durability 24 months), 86% reduction in surgeries, and no dose-limiting toxicities.
- Confirmatory trial enrolling 35 patients, aligned with FDA, to support long-term efficacy and safety.

**【COO Manufacturing Update】**
- Upgraded in-house GMP facility for gorilla adenovirus manufacturing, validated with FDA.
- Partnered with commercial CDMO for fill/finish operations, ensuring end-to-end control and cost efficiency.
- Confident in supply chain readiness for commercial launch with >$97M cash runway.

**【CCO Commercial Strategy】**
- Targeting 500 fellowship-trained otolaryngologists in urban centers, supported by 15-20 field representatives via EVERSANA partnership.
- Estimated 27,000 adult RRP patients in the U.S. (vs. prior 20,000), driven by unmet need for non-surgical treatment.
- Launch expected Q3 2025 with focus on early diagnosis and treatment to prevent irreversible vocal cord damage.

**【CFO Financial Overview】**
- 2024 net loss: $126.2M (incl. $55M non-cash charges), cash burn: $76.8M.
- Raised $79M via preferred stock issuance and $8.5M from IP monetization, ending year with $97.9M cash.
- Anticipated revenue from PRGN-2012 launch, contingent on FDA approval.

**【Q&A Highlights】**
- FDA interactions: Close alignment throughout review; manufacturing inspection expected pre-PDUFA.
- Patient identification: 86% of trial patients reduced surgeries; awareness campaigns targeting undiagnosed cases.
- Payer engagement: Value-based pricing discussions; most payers expect PA to label with treat-to-trial criteria.
- Field force: 15-20 reps focused on high-volume academic centers, complemented by remote engagement.
- Confirmatory trial: Final data expected 2026-2027; interim updates to be shared as appropriate.

Actual												-0.35	-0.26	-0.18	-0.23	-0.11	-0.1	-0.15	-0.13	-0.1	-0.13	-0.04	-0.11	-0.1	-0.08	-0.08	-0.13	-0.1	-0.23	-0.09	-0.0737	-0.18	-0.09	-1.06	-0.07
Forecast												-0.24	-0.135	-0.14	-0.17	-0.13	-0.1242	-0.1467	-0.12	-0.105	-0.145	-0.135	-0.1	-0.0925	-0.1005	-0.08	-0.079	-0.088	-0.0957	-0.0863	-0.0525	-0.13	-0.0867	-0.0939	-0.084
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-45.83%	-92.59%	-28.57%	-35.29%	+15.38%	+19.48%	-2.25%	-8.33%	+4.76%	+10.34%	+70.37%	-10.00%	-8.11%	+20.40%	0.00%	-64.56%	-13.64%	-140.33%	-4.29%	-40.38%	-38.46%	-3.81%	-1028.86%	+16.67%

Actual	--	--	--	--	--	--	--	--	--	--	--	29.84M	30.42M	23.58M	19.33M	24.51M	33.58M	21.60M	24.22M	32.02M	2.91M	16.72M	1.80M	1.85M	1.77M	1.38M	1.23M	1.06M	717.00K	953.00K	1.19M	1.34M	878.00K	2.92M	9.66M
Forecast	--	--	--	--	--	--	--	--	--	--	--	10.50M	16.14M	17.70M	21.20M	24.00M	21.06M	20.94M	24.30M	28.32M	22.54M	2.72M	6.21M	2.23M	2.15M	1.60M	2.13M	1.48M	1.29M	931.40K	3.02M	650.00K	952.00K	500.00K	8.42M
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+184.17%	+88.55%	+33.21%	-8.81%	+2.12%	+59.42%	+3.13%	-0.34%	+13.05%	-87.08%	+514.78%	-71.02%	-16.81%	-17.82%	-13.59%	-42.47%	-28.04%	-44.48%	+2.32%	-60.66%	+106.31%	-7.77%	+484.40%	+14.72%

PGEN

PGEN fundamentals

PGEN Q4 2025 Earnings

Earnings Call

You can ask Aime

PGEN

PGEN fundamentals

PGEN Q4 2025 Earnings

Earnings Call

PGEN Earnings Call Summary for Q4/20254:30 PM on Mar 25, 2026

PGEN Earnings Call Summary for Q3/20254:30 PM on Nov 13, 2025

PGEN Earnings Call Summary for Q2/20254:00 PM on Aug 13, 2025

PGEN Earnings Call Summary for Q1/20254:00 PM on May 13, 2025

PGEN Earnings Call Summary for Q4/20244:30 PM on Mar 19, 2025

You can ask Aime