Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth

Rhea-AI Summary

Precigen (Nasdaq: PGEN) reported second quarter 2026 net product revenue of $53.1 million from PAPZIMEOS, more than double the prior quarter, driving total revenue to $55.0 million and net income of $20.1 million ($0.05 diluted EPS) versus a prior-year net loss of $26.6 million.

For the first six months of 2026, total revenue reached $78.2 million, including $74.7 million from PAPZIMEOS, generating net income of $12.1 million compared with a $80.8 million loss a year earlier. Cash, cash equivalents and investments totaled $38.7 million at June 30, 2026, and, according to Precigen, together with anticipated PAPZIMEOS revenue are expected to fund operations through cash flow break-even by year-end 2026.

PAPZIMEOS adoption includes well over 500 patient hub enrollments, payer coverage across about 315 million US lives, a permanent J-code (J3404), and seven-year FDA market exclusivity. An EMA marketing application is under review and a redosing study is enrolling.

Positive

• PAPZIMEOS Q2 2026 revenue $53.1M, more than double prior quarter
• Total Q2 2026 revenue $55.0M vs $0.9M prior-year quarter
• Q2 2026 net income $20.1M vs $26.6M net loss in 2025
• First-half 2026 revenue $78.2M vs $2.2M prior-year period
• First-half 2026 net income $12.1M vs $80.8M net loss in 2025
• Seven-year FDA market exclusivity for PAPZIMEOS and EMA MAA under review

Negative

• Q2 2026 SG&A expenses $22.2M, up $6.1M year over year
• First-half 2026 SG&A expenses $43.3M, up $14.8M year over year
• Interest expense first-half 2026 $5.9M, up from near-zero prior-year period
• Long-term debt $93.9M outstanding as of June 30, 2026
• Cash and investments $38.7M at June 30, 2026 vs about $100.4M at year-end 2025

Market Reaction – PGEN

+12.10% $7.32 2.1x vol

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$7.32 Last Price

$6.37 $7.50 Day Range

$2.61B Market Cap

2.1x Rel. Volume

Following this news, PGEN has gained 12.10%, reflecting a significant positive market reaction. Our momentum scanner has triggered 3 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $7.32. Trading volume is elevated at 2.1x the average, suggesting notable buying interest.

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Market Context

The stock is surging +11.6% following this news. Historical earnings event 1057076 produced a 10.84%...

Analysis

The stock is surging +11.6% following this news. Historical earnings event 1057076 produced a 10.84% 24-hour reaction. This report adds quarterly profitability and accelerating PAPZIMEOS revenue, while insider_context recorded Net Selling and an S-3 resale registration was not effective.

Key Figures

PAPZIMEOS net revenue: $53.1 million Cash, equivalents and investments: $38.7 million Patient hub enrollment: Well over 500 patients +5 more

8 metrics

PAPZIMEOS net revenue $53.1 million Second quarter of 2026; more than double the prior quarter

Cash, equivalents and investments $38.7 million As of June 30, 2026

Patient hub enrollment Well over 500 patients Across major centers and community practices

Market exclusivity Seven years Granted by the FDA for PAPZIMEOS

Total revenues $55.0 million Three months ended June 30, 2026

Net income $20.1 million Second quarter of 2026; $0.06 basic and $0.05 diluted per share

Six-month net income $12.1 million Six months ended June 30, 2026; $0.03 basic and diluted per share

Payer coverage Approximately 315 million US lives Nearly 100% of insured lives nationwide

Previous Earnings Reports

5 past events · Latest: May 13 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 13	1Q26 earnings report	Positive	+10.8%	PAPZIMEOS launch revenue increased while net loss narrowed year over year
Mar 25	FY25 earnings report	Positive	+25.5%	PAPZIMEOS commercialization advanced alongside improved market protection and cash runway
Nov 13	3Q25 earnings report	Positive	+25.6%	FDA approval supported commercialization, patient enrollment, and durable clinical response disclosures
May 14	1Q25 earnings report	Positive	+2.3%	PRGN-2012 clinical results and FDA priority review supported development progress
Mar 19	FY24 earnings report	Positive	+0.6%	PRGN-2012 regulatory progress and clinical response data accompanied financing disclosures

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

The five tag-specific earnings events all aligned with positive 24-hour price reactions, averaging 12.97%.

Key Terms

market exclusivity, permanent j-code, marketing authorization application, cooperative research and development agreement, +1 more

5 terms

market exclusivity regulatory

"PAPZIMEOS was granted seven years of market exclusivity by the FDA"

Market exclusivity is a limited legal protection that prevents rivals from selling the same drug or product for a set time, even if others could otherwise make a copy. It’s like a temporary shop window reserved for one seller, giving that company sole access to customers for that product. For investors, exclusivity can mean predictable sales and higher profit margins during the protected period, and the impending end of exclusivity is a key risk factor.

permanent j-code regulatory

"The Centers for Medicare and Medicaid Services assigned permanent J-code"

Permanent J-code is a standardized billing code in the HCPCS Level II system assigned by the Centers for Medicare & Medicaid Services to identify a specific injectable drug or biologic for use in claims and reimbursement. It replaces temporary or miscellaneous codes and creates a consistent label—like giving a medicine a permanent SKU—that insurers and providers use to bill and track use. For investors, a permanent J-code can make revenue forecasts, market uptake and reimbursement comparisons clearer because it improves coding stability and pricing transparency.

marketing authorization application regulatory

"The European Medicines Agency (EMA) has validated and is reviewing the Marketing Authorization Application"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

cooperative research and development agreement regulatory

"under a cooperative research and development agreement (CRADA) with the National Cancer Institute"

A cooperative research and development agreement (CRADA) is a formal partnership between a government research lab and a private company to jointly develop technology or products, with each side contributing staff, facilities, or funding while agreeing on how results and patents are shared. For investors, a CRADA can speed development, lower costs and give a company access to specialized government expertise or facilities—similar to renting a well-equipped workshop with shared ownership of whatever is built—potentially improving the odds of commercial success.

open-label study medical

"The Company's open-label study to evaluate redosing efficacy"

An open-label study is a type of research where both the participants and the researchers know which treatment or intervention is being administered. This transparency can influence the results, making it important for investors to consider potential biases or limitations when evaluating the study’s findings. Understanding this helps assess the reliability of evidence supporting new products or therapies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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., Aug. 4, 2026 /PRNewswire/ -- 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

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SOURCE Precigen, Inc.

FAQ

How did PAPZIMEOS revenue impact Precigen (PGEN) Q2 2026 financial results?

PAPZIMEOS generated $53.1 million in net revenue in Q2 2026, more than double the prior quarter. According to Precigen, this revenue drove total quarterly revenue to $55.0 million and helped the company achieve net income of $20.1 million for the period.

Did Precigen (PGEN) report profitability in the second quarter of 2026?

Yes, Precigen reported net income of $20.1 million in Q2 2026. According to Precigen, this compares with a net loss of $26.6 million in the prior-year quarter and was primarily driven by strong commercial sales of PAPZIMEOS in the United States.

What were Precigen (PGEN) total revenues for the first half of 2026?

Precigen reported $78.2 million in total revenues for the six months ended June 30, 2026. According to Precigen, PAPZIMEOS sales accounted for $74.7 million of this amount, compared with total revenues of $2.2 million in the same period of 2025.

What is Precigen’s cash position and outlook for cash flow break-even in 2026?

Precigen held $38.7 million in cash, cash equivalents and investments as of June 30, 2026. According to Precigen, this balance, together with anticipated PAPZIMEOS revenue, is expected to fund operations through cash flow break-even by the end of 2026.

What regulatory advantages does PAPZIMEOS provide for Precigen (PGEN) as of Q2 2026?

PAPZIMEOS has seven-year FDA market exclusivity and orphan drug designation in Europe. According to Precigen, the EMA has validated and is reviewing a Marketing Authorization Application, and PAPZIMEOS also benefits from a permanent J-code (J3404) to support reimbursement.

How broad is PAPZIMEOS market access and adoption in the United States?

PAPZIMEOS has payer coverage across approximately 315 million US insured lives and over 500 patient hub enrollments. According to Precigen, it is being adopted across major medical centers and community practices, supported by a permanent J-code and growing physician consensus.

What were the main expense trends for Precigen (PGEN) in Q2 2026?

In Q2 2026, SG&A expenses rose to $22.2 million, up $6.1 million year over year, while R&D declined. According to Precigen, higher SG&A reflected commercialization activities for PAPZIMEOS, and the company expects R&D expenses to increase as the year progresses.