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- **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

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

PGEN

PGEN fundamentals

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