Precigen (Nasdaq: PGEN) turns profitable as PAPZIMEOS Q2 2026 sales hit $53.1M
Rhea-AI Filing Summary
Precigen, Inc. reported a historic second quarter 2026, with total revenues of $55.0 million driven largely by PAPZIMEOS sales of $53.1 million for recurrent respiratory papillomatosis. The company generated net income of $20.1 million, or $0.06 per basic share, versus a $26.6 million loss a year earlier.
For the first six months of 2026, revenues reached $78.2 million and net income was $12.1 million, compared with an $80.8 million loss in the prior-year period, largely reflecting commercial PAPZIMEOS sales. R&D expenses declined due to capitalization of PAPZIMEOS manufacturing costs, while SG&A increased with launch-related spending. As of June 30, 2026, balance sheet figures (amounts in thousands) included cash and cash equivalents of $16,329, short-term investments of $21,879, long-term debt of $93,880, and shareholders' equity of $43,576, and management expects existing cash and PAPZIMEOS cash flows to fund operations through cash flow break-even by the end of 2026.
Positive
- Returned to profitability with Q2 2026 net income of $20.1 million and six-month net income of $12.1 million, compared with significant net losses in the prior-year periods.
- Strong PAPZIMEOS commercialization, generating $53.1 million of Q2 revenue and $74.7 million in the first half of 2026, driving rapid top-line growth.
- Balance sheet improvement as shareholders' equity increased to $43,576 thousand at June 30, 2026 from $20,911 thousand at December 31, 2025.
Negative
- None.
Insights
Analyzing...
8-K Event Classification
Key Figures
Key Terms
recurrent respiratory papillomatosis (RRP) medical
AdenoVerse medical
orphan drug designation regulatory
warrant liabilities financial
right-of-use assets financial
Earnings Snapshot
Management stated that based on current revenue trajectory and forecast, cash and anticipated PAPZIMEOS sales are expected to fund operations through cash flow break-even by the end of 2026, and R&D expenses are expected to increase as the year progresses.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
How did Precigen (PGEN) perform financially in Q2 2026?
What were PAPZIMEOS revenues for Precigen (PGEN) in Q2 and the first half of 2026?
Did Precigen (PGEN) achieve profitability for the first half of 2026?
What is Precigen’s (PGEN) cash, investment, and debt position as of June 30, 2026?
How did operating expenses change for Precigen (PGEN) with the PAPZIMEOS launch?
What outlook did Precigen (PGEN) provide on future profitability and cash flow?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip code)
(
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
Trading |
Name
of each exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
Attached as Exhibit 99.1 is a copy of a press release of Precigen, Inc., dated August 4, 2026, reporting its financial results for the quarter ended June 30, 2026.
This information, including the Exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description |
| 99.1 | Press release dated August 4, 2026 |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Precigen, Inc. | ||
| By: | /s/ Donald P. Lehr | |
| Donald P. Lehr | ||
| Chief Legal Officer | ||
Dated: August 4, 2026
Exhibit 99.1
Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth
| · | PAPZIMEOS® net revenue of $53.1 million in the second quarter of 2026, more than double the prior quarter, reflects accelerating commercial momentum and broad US adoption |
| · | PAPZIMEOS revenue propelled the Company to quarterly profitability |
| · | Cash, cash equivalents, and investments totaled $38.7 million as of June 30, 2026, which together with proceeds from PAPZIMEOS revenue, is expected to support cash flow break-even by the end of 2026 |
| · | PAPZIMEOS patient hub enrollment reached well over 500 patients across major centers and community practices, demonstrating expanding reach and ease of administration across treatment settings |
| · | FDA granted PAPZIMEOS seven-year market exclusivity, providing long-term protection against prospective competition |
| · | Conference call scheduled for 4:30 PM ET today |
GERMANTOWN, MD, August 4, 2026 – Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced second quarter 2026 financial results and business updates.
“We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy,” said Helen Sabzevari, PhD, President and CEO of Precigen. “This momentum provides a strong foundation for our next phase of growth as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform’s ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders.”
“We continue to see the key elements of the PAPZIMEOS commercial launch drive revenue growth: 100% field engagement with our initial target accounts, active patient and HCP campaigns, a permanent J-code supporting access and site activations, payer coverage across nearly all insured US lives, growing physician consensus reflected in a RRP position paper, and continued patient hub enrollments,” said Phil Tennant, Chief Commercial Officer of Precigen. “This progress translated into strong quarterly revenue growth and increasing adoption across major medical centers and community practices as PAPZIMEOS becomes established as a new standard of care for adults with RRP. We remain focused on converting demand into treated patients and further expanding access to PAPZIMEOS across the RRP community.”
KEY PROGRAM HIGHLIGHTS
PAPZIMEOS®: First-line Standard of Care for the Treatment of Adults with RRP
PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug Administration (FDA) for the treatment of adults with RRP.
| · | Broad US adoption: Well over 500 patients have registered through Precigen’s patient hub, with additional patients outside of the hub being identified and receiving treatment as institutions support patient access directly and independently. |
| · | Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity by the FDA, providing long-term protection against prospective competition. PAPZIMEOS remains the first and only approved therapy for adults with RRP and the only treatment designed to target the underlying cause of the disease. |
| · | Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315 million US lives through private health plans, Medicare, and Medicaid, representing nearly 100% of insured lives nationwide. |
| · | Permanent J-code: The Centers for Medicare and Medicaid Services assigned permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code provides a standard pathway for reimbursement, helps institutions process claims more efficiently, and reduces uncertainty for sites that are still building PAPZIMEOS into their workflows. |
| · | First-line standard of care: An expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians recommended PAPZIMEOS as the first-line standard of care for adults with RRP in the United States. |
| · | Redosing study enrolling patients: The Company’s open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480). |
| · | MAA under review by the EMA: The European Medicines Agency (EMA) has validated and is reviewing the Marketing |
Authorization Application (MAA) submitted in November 2025 for zopapogene imadenovec for the treatment of adults with RRP. PAPZIMEOS has been granted orphan drug designation from the European Commission.
PRGN-2009 AdenoVerse® Immunotherapy in HPV-associated Cancers
PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.
| · | PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing. |
| · | A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing. |
| · | The Company plans to provide an update on progress across the AdenoVerse portfolio, including PRGN-2009, by the end of the year. |
FINANCIAL RESULTS
“We are thrilled to report that Precigen achieved profitability in the second quarter, marking a significant milestone for the company. Net income was driven by strong PAPZIMEOS revenue of $53.1 million. As we progress through the third quarter of 2026, we are seeing continued growth in PAPZIMEOS demand," said Harry Thomasian Jr., Chief Financial Officer of Precigen. “Based upon our current revenue trajectory and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026.”
Second Quarter 2026 Financial Results Compared to Prior Year Period
Total revenues were $55.0 million for the three months ended June 30, 2026, an increase of $54.1 million compared to the three months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the three months ended June 30, 2026 were $53.1 million.
Cost of products and services increased by $1.7 million, compared to the three months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.
R&D expenses decreased by $4.2 million, compared to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.
SG&A expenses increased by $6.1 million, compared to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.
In the three months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the second quarter of 2026.
Total other expense, net was $2.6 million for the three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7 million. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change primarily relates to an increase of $3.0 million in interest expense related to long term debt that originated in the third quarter of 2025.
Net income was $20.1 million, or $0.06 per basic and $0.05 per diluted share for the three months ended June 30, 2026, compared to a net loss of $26.6 million, or $(0.09) per basic and diluted share, for the three months ended June 30, 2025.
First Six Months 2026 Financial Results Compared to Prior Year Period
Total revenues were $78.2 million for the six months ended June 30, 2026, an increase of $76.0 million compared to the six months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the six months ended June 30, 2026 were $74.7 million.
Cost of products and services increased by $3.2 million, compared to the six months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.
R&D expenses decreased by $9.0 million, compared to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.
SG&A expenses increased by $14.8 million, compared to the six months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.
In the six months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the six months ended June 30, 2026.
Total other expense, net decreased by $21.9 million, compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $5.9 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.
Net income was $12.1 million, or $0.03 per basic and diluted share for the six months ended June 30, 2026, compared to a net loss of $80.8 million, or $(0.27) per basic and diluted share, for the six months ended June 30, 2025.
###
Precigen: Advancing Medicine with Precision®
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube.
Trademarks
Precigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what the Company expects. Examples of forward-looking statements include, among others, information relating to the Company’s business and business plans, the success of efforts to commercialize PAPZIMEOS® (zopapogene imadenovec-drba) for the treatment of recurrent respiratory papillomatosis (RRP) in adults including the revenue that the Company expects to realize from such efforts, the Company’s ability to successfully obtain foreign regulatory approvals for PAPZIMEOS, expectations about the safety and efficacy of PAPZIMEOS, the ability of PAPZIMEOS to treat RRP, the Company’s future financial and operational results including the Company’s ability to reach quarterly profitability and cash flow break-even, and the Company’s ability to commence clinical studies or complete ongoing clinical studies for the Company’s clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.
Investor Contact:
Steven M. Harasym
Tel: +1 (202) 365-2563
investors@precigen.com
Media Contact:
Donelle M. Gregory
press@precigen.com
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
| (Amounts in thousands) | June 30, 2026 | December 31, 2025 | |
| Assets | |||
| Current assets | |||
| Cash and cash equivalents | $ 16,329 | $ 30,234 | |
| Short-term investments | 21,879 | 67,624 | |
| Receivables | |||
| Trade, net | 71,866 | 3,916 | |
| Other | 178 | 446 | |
| Inventory | 20,245 | 9,581 | |
| Prepaid expenses and other | 3,887 | 3,434 | |
| Total current assets | 134,384 | 115,235 | |
| Long-term investments | 490 | 2,511 | |
| Property, plant and equipment, net | 12,802 | 13,758 | |
| Intangible assets, net | 2,545 | 3,182 | |
| Goodwill | 15,232 | 15,232 | |
| Right-of-use assets | 4,135 | 4,679 | |
| Other assets | 708 | 908 | |
| Total assets | $ 170,296 | $ 155,505 | |
| Liabilities and Shareholders' Equity | |||
| Current liabilities | |||
| Accounts payable | $ 5,304 | $ 11,985 | |
| Accrued compensation and benefits | 6,498 | 10,199 | |
| Other accrued liabilities | 16,212 | 10,993 | |
| Indemnification accruals | — | 2,476 | |
| Deferred revenue | 284 | 517 | |
| Current portion of lease liabilities | 1,055 | 1,136 | |
| Total current liabilities | 29,353 | 37,306 | |
| Long-term debt | 93,880 | 93,174 | |
| Lease liabilities, net of current portion | 3,410 | 3,980 | |
| Other long-term liabilities | 77 | 134 | |
| Total liabilities | 126,720 | 134,594 | |
| Shareholders' equity | |||
| Additional paid-in capital | 2,372,811 | 2,362,252 | |
| Accumulated deficit | (2,329,206) | (2,341,348) | |
| Accumulated other comprehensive (loss) income | (29) | 7 | |
| Total shareholders' equity | 43,576 | 20,911 | |
| Total liabilities and shareholders' equity | $ 170,296 | $ 155,505 |
Precigen, Inc. and Subsidiaries
Consolidated Statement of Operations
(Unaudited)
| (Amounts in thousands, except share |
Three Months Ended June 30, |
Six Months Ended June 30, | |||||
| and per share data) | 2026 | 2025 | 2026 | 2025 | |||
| Revenues | |||||||
| Product revenues, net | $ 53,262 | $ 41 | $ 75,090 | $ 244 | |||
| Service revenues | 1,716 | 815 | 3,140 | 1,953 | |||
| Total revenues | 54,978 | 856 | 78,230 | 2,197 | |||
| Operating Expenses | |||||||
| Cost of products and services | 2,805 | 1,092 | 5,364 | 2,192 | |||
| Research and development | 7,282 | 11,488 | 12,920 | 21,966 | |||
| Selling, general and administrative | 22,249 | 16,133 | 43,298 | 28,492 | |||
| Impairment of goodwill | — | 3,907 | — | 3,907 | |||
| Total operating expenses | 32,336 | 32,620 | 61,582 | 56,557 | |||
| Operating income (loss) | 22,642 | (31,764) | 16,648 | (54,360) | |||
| Other Income (Expense), Net | |||||||
| Change in fair value of warrant liabilities | — | 4,460 | — | (28,021) | |||
| Interest expense | (2,953) | — | (5,861) | (1) | |||
| Interest income | 366 | 696 | 1,049 | 1,614 | |||
| Other income (expense), net | 16 | (31) | 306 | (24) | |||
| Total other income (expense), net | (2,571) | 5,125 | (4,506) | (26,432) | |||
| Income (loss) before income taxes | 20,071 | (26,639) | 12,142 | (80,792) | |||
| Income tax expense | — | (3) | — | (3) | |||
| Net income (loss) | $ 20,071 | $ (26,642) | $ 12,142 | $ (80,795) | |||
| Net income (loss) per share | |||||||
| Net income (loss) per share, basic | $ 0.06 | $ (0.09) | $ 0.03 | $ (0.27) | |||
| Net income (loss) per share, diluted | $ 0.05 | $ (0.09) | $ 0.03 | $ (0.27) | |||
| Weighted average shares outstanding, basic | 356,893,568 | 296,434,726 | 355,599,477 | 295,164,303 | |||
| Weighted average shares outstanding, diluted | 413,686,865 | 296,434,726 | 412,552,647 | 295,164,303 | |||