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Precigen (PGEN) FY2025 results: revenue $10 million, up 146.7% on the year

Precigen, Inc. (PGEN) reported revenue of $10 million for fiscal 2025, the year ended 31 December 2025, up 146.7% on the year before. Net income was -$251 million, and diluted earnings per share $-1.37. The figures are the company's own, from the 10-K it filed with the SEC on 25 March 2026.

Revenue
$10 million
+146.7% on the year
FY2018FY2025
Operating margin
-1141.1%
-3440.2% a year earlier
FY2018FY2025
Net income
-$251 million
FY2018FY2025
Diluted EPS
-$1.37
FY2018FY2025

this yearthe year beforeHover a bar for its figure.

The year in brief

What management said about the year

Guidance figures: 2 new.

  • First PAPZIMEOS sales recorded in Q4: The company reported PAPZIMEOS net product revenue of $3.4 million in the fourth quarter of 2025, its first partial quarter of US commercial sales as payer policies took effect.
  • Full-year revenue rose $5.8 million: Total revenues were $9.7 million in 2025 against $3.9 million in 2024, with PAPZIMEOS product revenue as the main driver of the increase.
  • Net loss was $1.37 per share: Net loss attributable to common shareholders was $429.6 million, or $1.37 per basic and diluted share, against a net loss of $126.2 million, or $0.47 per share, in 2024.
  • Patient hub passes 300 registrations: Hub enrollment has surpassed 300 registered patients, and the company said further patients have been identified through field engagement outside the hub.
  • SG&A rose $28.8 million on launch: SG&A expenses rose $28.8 million, or 69.8%, mainly from a $27.3 million increase in PAPZIMEOS commercial readiness costs, including sales force expansion and marketing.
Read the Q4 FY2025 earnings call summary

From this 10-K

Precigen is a commercial-stage biopharmaceutical company that works on precision medicines in immuno-oncology, autoimmune disorders and infectious diseases. Its one approved product is Papzimeos (zopapogene imadenovec-drba, PRGN-2012), which the FDA approved in August 2025 for adults with recurrent respiratory papillomatosis (RRP). At 31 December 2025 it had 160 employees, 140 of them in healthcare operations.

Precigen, Inc., the 10-K for 2025

Precigen is a commercial-stage biopharmaceutical company that works on precision medicines in immuno-oncology, autoimmune disorders and infectious diseases. Its one approved product is Papzimeos (zopapogene imadenovec-drba, PRGN-2012), which the FDA approved in August 2025 for adults with recurrent respiratory papillomatosis (RRP). At 31 December 2025 it had 160 employees, 140 of them in healthcare operations.

What it sells

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen made from selected regions of human papillomavirus (HPV) types 6 and 11 proteins. It is given as four subcutaneous injections over a 12-week interval. RRP is a rare disease caused by chronic HPV 6 or HPV 11 infection. It causes recurrent benign tumors in the respiratory tract and has mostly been managed with repeated surgeries. The company says Papzimeos is the first and only FDA-approved therapy for adults with RRP, and it estimates about 27,000 adults in the United States live with the disease.

In the pivotal study, 18 of 35 patients (51%) needed no surgeries in the 12 months after treatment. Papzimeos has Breakthrough Therapy Designation and Orphan Drug designation from the FDA. It also has Orphan Drug Designation from the European Commission. A Marketing Authorization Application was submitted to the EMA in November 2025, has been validated and is under review.

The company sells in the United States with a field sales team, Medical Science Liaisons and a patient support program called Papzimeos Support. It selected Eversana to support launch strategy and commercialization. It reports private health plan coverage of about 215 million lives, and Papzimeos is also covered under Medicare and Medicaid. Sales began in the fourth quarter of 2025. Revenue is recognized when product is delivered to the site of care or a specialty pharmacy.

How its technology works

AdenoVerse is a library of engineered adenovectors, including gorilla adenovectors, used to deliver therapeutic genes and vaccine antigens. The company says these vectors can carry a genetic payload of up to 12kb and can be given repeatedly. It reports that the gorilla variant GC46 has a seroprevalence of less than 6 percent in the United States, against an estimated 58 percent for Ad5.

UltraCAR-T uses the Sleeping Beauty non-viral system, licensed from the University of Texas MD Anderson Cancer Center, to build CAR-T cells that carry a CAR, a kill switch and membrane-bound interleukin-15 (mbIL15). The company describes a process in which cells are made overnight at a medical center's cGMP facility and returned to the patient the next day. The UltraPorator electroporation device supports this process, and the FDA has cleared it as a manufacturing device for clinical trials of the company's UltraCAR-T therapies. The company also owns the RheoSwitch gene switch system, which responds to an orally available activator ligand.

Its pipeline

PRGN-2009 is an AdenoVerse immunotherapy for HPV-associated cancers. It is in two Phase 2 trials in newly diagnosed HPV-associated oropharyngeal cancer, and in a randomized Phase 2 trial with pembrolizumab in recurrent or metastatic cervical cancer. All are run with the National Cancer Institute under a cooperative research and development agreement.

PRGN-3006 targets CD33 in relapsed or refractory acute myeloid leukemia. Enrollment in its Phase 1b trial is complete, and the FDA has granted it Orphan Drug designation in AML and Fast Track Designation in relapsed or refractory AML. The company says it plans to focus on strategic partnerships to advance this program. Enrollment is paused in the trials of PRGN-3005 (ovarian cancer, MUC16) and PRGN-3007 (ROR1), a decision announced in August 2024. The company shut down the operations of ActoBio in 2024 and says its intellectual property is available for prospective transactions.

Precigen Exemplar

Exemplar provides MiniSwine Yucatan miniature pig research models and services. The models are genetically engineered to show human disease states. Its customers are industry and academic researchers developing small molecule, gene and cell therapies. Exemplar had 20 employees at 31 December 2025 and works from about 57,711 square feet of production, lab and office space in Sioux County and Johnson County, Iowa.

Where it works and its people

The main research, development and production site is in Germantown, Maryland. The company built cGMP manufacturing capability for AdenoVerse-based products there and expanded drug substance capacity to support the Papzimeos launch. Of the 160 employees, 47 support research and development, and 35 of those have advanced degrees, including 17 PhDs. None are covered by a collective bargaining agreement.

Competition and patents

The company says many competitors have greater financial, technical and human resources. For RRP it names INOVIO Pharmaceuticals as its main competitor, whose INO-3107 BLA is under FDA review. For PRGN-2009 it lists several HPV immunotherapy developers, including BioNTech SE and PDS Biotechnology. In cell therapy it names companies such as Regeneron Pharmaceuticals, Anixa Biosciences and Allogene Therapeutics.

The company relies on patents, trade secrets and confidentiality agreements. Its last-to-expire patents run to 2032 for switch technologies, 2044 for genetic componentry and 2046 for gene delivery technologies.

From Precigen's annual report on Form 10-K for the year ended 31 December 2025. The filing

Written from the 10-K filed 25 March 2026: read the full 10-K.

The four quarters: Q1 FY2025 · Q2 FY2025 · Q3 FY2025 · Q4 FY2025

Income statement (profit and loss)

$ millionFY2025FY2024FY2023On the yearLast 8 years
Revenue9.73.96.2+146.7%
Research and development41.353.148.6-22.1%
Selling, general and administrative70.141.340.4+69.8%
Operating income-111-135-99.8
Operating margin-1141.1%-3440.2%-1602.5%
Interest expense3.90.00.5+64,350.0%
Pre-tax income-251-128-96.4
Income tax0.0-1.8-0.5
Net income-251-126-95.9
Net margin-2588.2%-3216.2%-1540.6%
Diluted EPS-$1.37-$0.47-$0.39
$ million except per share.
Read moreFree cash flow is operating cash flow less capital expenditure; the effective tax rate is income tax over pre-tax income; margins are the line over revenue. Gross profit is revenue less cost of revenue, and operating income is revenue less the company's own total costs, where the statement does not print those lines. Those four are arithmetic on the filed numbers; everything else is as filed. Money is in $ million as the company files it, or in $ billion by the switch above the tables; per share figures and share counts are as they are.

Cash flow

$ millionFY2025FY2024FY2023On the yearLast 8 years
Operating cash flow-87.8-68.2-66.9
Capital expenditure2.08.61.5-76.8%
Free cash flow-89.8-76.8-68.5
Free cash flow margin-927.6%-1955.6%-1099.9%
Cash from investing-1.5-20.7-3.1
Cash from financing90.011129.6-18.6%
Depreciation and amortisation3.24.56.7-29.3%
Share-based compensation10.99.59.9+14.7%
Diluted shares, weighted313m268m245m+16.9%
Shares outstanding at period end354m107m249m+230.4%

Balance sheet

$ millionFY2025FY2024FY2023On the yearLast 8 years
Shareholders' equity20.938.5118-45.7%
Redeemable equity0.028.20.0
Debt93.20.00.0
Operating lease liabilities4.04.55.9-12.5%
Other liabilities37.474.026.6-49.4%
Total liabilities and equity156145151+7.0%
Fixed assets13.813.87.1-0.5%
Goodwill15.219.126.6-20.4%
Intangible assets3.24.540.7-28.6%
Investments70.168.455.3+2.5%
Cash and equivalents30.229.57.6+2.4%
Receivables3.90.90.9+322.9%
Other assets19.09.012.9+111.5%
Total assets156145151+7.0%

10-K for the year ended 31 December 2025, filed 25 March 2026: the filing.