Precigen (PGEN) investor relations material

Executive summary

• Achieved quarterly profitability in Q2 2026, driven by PAPZIMEOS revenue of $53.1 million, more than doubling sequentially and marking the first FDA-approved therapy for adults with RRP.

• PAPZIMEOS is establishing itself as the new standard of care for adults with RRP, with over 500 patient hub enrollments, broadening patient access, and expanding use across major medical centers and community practices.

• FDA granted PAPZIMEOS seven-year market exclusivity for adult RRP patients, extending protection through August 2032.

• EMA review ongoing for PAPZIMEOS marketing authorization in Europe; Orphan Drug Designation granted by European Commission.

• Strategic pipeline prioritization led to pausing enrollment in certain clinical trials and the shutdown of ActoBio operations.

Financial highlights

• Total Q2 2026 revenues were $55 million, with $53.1 million from PAPZIMEOS; H1 2026 revenues reached $78.2 million.

• Gross margin for Q2 was $52.2 million, or 95%, expected to stabilize in the high 80%-low 90% range after pre-launch inventory is sold.

• Net income for Q2 2026 was $20.1 million ($0.05 per diluted share, $0.06 per basic share); H1 2026 net income was $12.1 million.

• Operating income for Q2 2026 was $22.6 million, compared to a loss of $31.8 million in Q2 2025.

• Cash, cash equivalents, and investments totaled $38.7 million as of June 30, 2026; long-term debt was $93.9 million.

Outlook and guidance

• Gross margins for PAPZIMEOS expected to stabilize between high 80% and low 90% after pre-launch inventory is sold.

• R&D expenses are expected to increase as pipeline advances, with pipeline updates including PRGN-2009 in HPV-driven cancers expected by year-end.

• Current financial forecast indicates operations will be funded through cash flow breakeven by end of 2026.

• Continued growth anticipated, supported by payer coverage, account activation, and patient demand.

• Majority of future revenues expected from PAPZIMEOS as commercial activities expand.