Precigen — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for the three months ended September 30, 2026, were $74.1 million, an increase of $71.2 million compared to $2.9 million in the same period in 2025.
• PAPZIMEOS net product revenue was $72.9 million for the quarter, representing a 37% quarter-over-quarter increase; launch-to-date net product revenue totaled $151 million.
• Net income for the quarter was $35.8 million, or $0.10 per basic share and $0.08 per diluted share, compared to a net loss of $325.3 million ($1.06 per share) in the prior-year period.
• Net income for the nine months ended September 30, 2026, was $47.9 million, or $0.13 per basic share and $0.12 per diluted share, compared to a net loss of $406.1 million ($1.36 per share) in the prior-year period.
• Net cash provided by operating activities was $11.9 million in the third quarter of 2026, achieving positive cash flow a full quarter ahead of guidance.
• Cash, cash equivalents, and investments totaled $51.0 million as of September 30, 2026.
• Long-term debt was $94.3 million as of September 30, 2026, compared to $93.2 million as of December 31, 2025.
• Cost of products and services increased to $6.5 million in the quarter (up from $1.0 million in 2025) and $11.9 million for the nine months (up from $3.2 million in 2025), driven by commercial sales of PAPZIMEOS.
• Research and development expenses decreased to $6.6 million in the quarter (down 46.4% from $12.4 million in 2025) and $19.6 million for the nine months (down 43.1% from $34.3 million in 2025) due to the capitalization of manufacturing costs post-FDA approval.
• Selling, general, and administrative (SG&A) expenses were $22.4 million in the quarter (down 6.8% from $24.0 million in 2025) and $65.7 million for the nine months (up 25.1% from $52.5 million in 2025).
• Total other expense, net decreased to $2.7 million in the quarter (down 97.6% from $111.9 million in 2025) and $7.2 million for the nine months (down 94.8% from $138.3 million in 2025), primarily due to the absence of a prior-year warrant liability fair value charge.
• Trade receivables increased to $96.5 million as of September 30, 2026, from $3.9 million as of December 31, 2025.
• Deferred revenue decreased to $0.2 million as of September 30, 2026, from $0.5 million as of December 31, 2025.

Guidance and Future Outlook:

• The company achieved positive cash flow in the third quarter of 2026, a full quarter ahead of its previous guidance to reach this milestone by year-end.
• Management expects continued revenue momentum as PAPZIMEOS adoption grows.
• The company is advancing a comprehensive lifecycle strategy for PAPZIMEOS, including an ongoing redosing clinical trial, pediatric development, and geographic expansion activities.
• The FDA Platform Technology Designation for the AdenoVerse platform is expected to expedite the development of current and future therapies.
• The European Medicines Agency (EMA) is reviewing the Marketing Authorization Application (MAA) for PAPZIMEOS, which was submitted in November 2025.

Business Segments and Product Lines:

• PAPZIMEOS (zopapogene imadenovec-drba) is the first FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP) and is established as the first-line standard of care.
• Over 500 patients have initiated PAPZIMEOS treatment, with over 300 having completed treatment.
• PAPZIMEOS demonstrated a 51% complete response rate in its pivotal study, with durable complete responses observed for up to five years.
• PAPZIMEOS has broad payer coverage across over 315 million US lives (nearly 100% of insured lives) and a permanent J-code (J3404) effective April 1, 2026.
• An open-label redosing study (NCT06538480) is ongoing to evaluate efficacy in partial responders.
• PRGN-2009, an investigational AdenoVerse immunotherapy, is in Phase 2 trials for newly diagnosed HPV-associated oropharyngeal cancer under a CRADA with the NCI and for recurrent/metastatic cervical cancer in combination with pembrolizumab.
• The company plans to present new Phase 2 clinical data for PRGN-2009 at a forthcoming R&D Day.

Market and Competitive Landscape:

• PAPZIMEOS holds a first-mover advantage as the first FDA-approved therapy for adults with RRP, supported by broad commercial access and adoption across academic and community settings.
• An independent expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) recommends PAPZIMEOS as the preferred first-line treatment.
• PAPZIMEOS is administered subcutaneously without the need for specialized devices, distinguishing it from previous surgical management approaches.

Risks and Challenges:

• Forward-looking statements regarding commercial success, regulatory approvals, safety, efficacy, and financial results are subject to risks and uncertainties that could cause actual results to differ materially.
• Specific risks include the ability to maintain profitability and positive cash flow, the success of foreign regulatory approvals, and the completion of ongoing clinical studies.

Management Commentary and Tone:

• CEO Helen Sabzevari stated the company has established an "exceptional position of strength" with commercial momentum driving the next phase of growth, noting PAPZIMEOS has "blockbuster potential."
• CCO Phil Tennant highlighted a "commanding first-mover advantage" and strong commercial execution, citing growing demand and physician preference.
• CFO Harry Thomasian Jr. described the quarter as a "significant financial milestone," attributing results to strong PAPZIMEOS uptake and disciplined spending.
• Dr. Clark A. Rosen noted the treatment represents a "remarkable advance" moving beyond disease management to sustained disease control.

Other Key Points:

• The FDA granted Platform Technology Designation to the AdenoVerse platform in September 2026.
• PAPZIMEOS received full FDA approval in August 2025 without the requirement for a post-approval confirmatory clinical trial.
• PAPZIMEOS has been granted orphan drug designation by the European Commission.
• All outstanding preferred shares were converted into common shares on September 15, 2025.
• A $179.0 million non-cash deemed dividend on preferred stock was recorded in the prior year periods but had no impact in 2026.
• A $3.9 million goodwill impairment charge was recorded in the nine months ended September 30, 2025, with no comparable charge in 2026.
• Conference call regarding the results was scheduled for 4:30 PM ET on November 4, 2026.