Key Highlights

  • Revenue was USD 74.15 million against a USD 71.55 million estimate, and diluted EPS was USD 0.08 against USD 0.06.
  • Product revenues were USD 72.96 million, and Net Income was USD 35.77 million against a loss of USD 146.34 million.
  • Cash and equivalents were USD 15.0 million and investments USD 36.0 million, with customer payment terms of 127 days.
  • The FDA granted platform technology designation to AdenoVerse in September 2026, and an EMA application is under review.

Precigen, Inc. (NASDAQ:PGEN) gave no numeric guidance with its third quarter results, so its outlook rests on stated priorities: expanding Papzimeos sales in recurrent respiratory papillomatosis and advancing regulatory steps in Europe. Revenue was USD 74.15 million, against an estimate of USD 71.55 million, and diluted EPS was USD 0.08, against an estimate of USD 0.06.

Outlook and Priorities Management Described

The company stated that the majority of its future revenues for the foreseeable future come from Papzimeos sales as commercial activities expand. It said its transition to sustained profitability depends on continued commercialization of Papzimeos and potential commercialization of other candidates. It reported profitability from continuing operations beginning in the second quarter of 2026, the first since its 2020 transformation into a healthcare company, and positive Operating Cash Flow of USD 11.9 million in the third quarter.

The company estimates approximately 27,000 adult patients in the United States live with the disease. The FDA granted seven-year Orphan Drug exclusivity through August 14, 2032, and a Marketing authorization application for zopapogene imadenovec-drba has been validated by the European Medicines Agency and is under review. A redosing trial is enrolling, and in September 2026 the FDA granted platform technology designation to the AdenoVerse immunotherapy platform.

The Quarter in Detail

Total revenues were USD 74.15 million against USD 2.92 million a year earlier. Product revenues were USD 72.96 million, as the company recorded commercial Papzimeos sales that had not begun in the prior-year quarter, and service revenues were USD 1.19 million. Collaboration and licensing revenues were nil, against USD 1.82 million a year earlier.

Cost of products and services was USD 6.51 million against USD 1.04 million. Research and Development expenses were USD 6.63 million against USD 12.38 million, which the company linked to production costs for Papzimeos now flowing through inventory and cost of sales, and to lower performance-based pay. SG&A expenses were USD 22.36 million against USD 23.99 million. Operating Income was USD 38.65 million against an operating loss of USD 34.48 million. Net other expense was USD 2.68 million against USD 111.86 million, a year that included a charge for Warrant liabilities.

Net income was USD 35.77 million. Nine-month revenue was USD 152.38 million and nine-month net income was USD 47.9 million.

Cash, Debt and Pipeline

Cash and cash equivalents were USD 15.0 million and investments were USD 36.0 million at September 30. Nine-month Operating Activities used USD 49.75 million, which management tied to growth in Accounts Receivable and inventory with the Papzimeos launch. The company holds a term Loan from Pharmakon Advisors-managed entities that matures in 2030, and its accumulated Deficit was USD 2.3 billion.

In the pipeline, PRGN-2009 is in Phase 2 trials in HPV-associated oropharyngeal cancer and cervical cancer. The company has completed enrollment in the Phase 1b trial of PRGN-3006 and paused enrollment in the PRGN-3005 and PRGN-3007 trials under a pipeline prioritization announced in August 2024.

Dates and Milestones Named

Revenue of USD 74.15 million sits alongside net income of USD 35.77 million, cash of USD 15.0 million and investments of USD 36.0 million. Papzimeos product revenue of USD 72.96 million compares with total operating expenses of USD 35.50 million.

Management named dated items: orphan drug exclusivity through August 14, 2032, the term loan maturing in 2030, and the pending European review. It also named priorities of continued Papzimeos commercial expansion, the redosing trial and advancement of PRGN-2009.