Precigen (PGEN) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 4, 2026

Source: earnings call transcript

Executive summary

Precigen Q2 FY26 — Strong PAP-SIMIUS Launch Drives Profitability

Precigen delivered an exceptional quarter, driven by the strong commercial momentum of PAP-SIMIUS, which propelled the company to profitability ahead of its first FDA approval anniversary. The launch continues to benefit from broad patient access, growing physician adoption across care settings, and favorable payer coverage, reinforcing confidence in its durable growth trajectory. The company is also advancing its pipeline, with updates expected for PRGN 2009 later this year.

Highlights

PAP-SIMIUS revenue grew by over 145% QoQ to $53.1 million in Q2 FY26.
Company achieved quarterly net profit of $20.1 million, a significant milestone prior to the first anniversary of FDA approval.
PAP-SIMIUS secured 7-year market exclusivity for adult RRP patients until August 2032.
Payer coverage for PAP-SIMIUS reached approximately 315 million lives, representing nearly all potential covered lives in the U.S. market.
PAP-SIMIUS durability data shows 83% of patients in ongoing complete response beyond three years, with some beyond four years surgery-free.

Guidance & targets

Category	Target	Timeline	Confidence
Cash flow breakeven	By the end of 2026 high materiality	FY26	High
Gross margins for PAP-SIMIUS	High 80 percentages to low 90 percentages medium materiality	Ongoing	High
R&D expenses	Increase as the year progresses low materiality	H2 FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
PAP-SIMIUS PAP-SIMIUS revenue showed significant acceleration, growing by $31.5 million from Q1 to Q2, driven by strong demand and continued build-up throughout the quarter. This product is the primary driver of the company's recent profitability. Q1 FY26 Revenue: $21.6 millionLaunch to date revenue (end of Q2 FY26): $78 million	$53.1 million	—	145.8%	—

What to watch in Q3 FY26

PAP-SIMIUS revenue growth rate

Q3 FY26

Current 145.8% QoQ ($53.1M in Q2)

Target Continued growth, level to be determined

Why it matters

To assess the sustainability of PAP-SIMIUS's commercial momentum and its contribution to overall financial performance.

The growth story will continue, the level at which we continue to grow will be determined when we get to the end of Q3.

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Q&A highlights

What growth rate should be expected from Q2 to Q3, and how many physicians/institutions are using the drug, particularly regarding hub vs. non-hub patients?

Management expects continued growth, though mathematically the rate may diminish over time compared to early launch. All leading indicators (payer coverage, J-code, account activation) support this. A high proportion of targeted accounts are using the drug, including IDNs and community settings. Many treated patients come from non-Hub institutions, indicating broad demand.

“The growth story will continue, the level at which we continue to grow will be determined when we get to the end of Q3. But all of the things that we've spoken about in terms of the leading indicators, the payer coverage, the account activation, the patients that are coming into play, the permanent J code, all of these things are leading to a continued growth story.”

asked by Jason Butler · answered by Phil Tennant

2 min read 5 chapters

Detailed narrative

PAP-SIMIUS Commercial Momentum

PAP-SIMIUS continues to demonstrate strong commercial momentum, with Q2 FY26 revenue reaching $53.1 million, a 145% increase from Q1 FY26. This performance is driven by broadening patient access, growing physician adoption across major medical centers and community practices, and increasing utilization. The full FDA approval and broad label, which does not impose a minimum number of prior surgeries, allows physicians to consider PAP-SIMIUS earlier in the treatment paradigm, leading to use across a wide range of RRP patients, not just severe cases.

PAP-SIMIUS Durability and Market Exclusivity

The clinical profile of PAP-SIMIUS, including its transformative efficacy, durability, and favorable safety, continues to resonate strongly. Long-term follow-up data shows 83% of patients in ongoing complete response beyond three years, with some beyond four years surgery-free, having received no other RRP treatment after PAP-SIMIUS. The FDA has granted PAP-SIMIUS seven-year market exclusivity for adult RRP patients, extending to August 2032, which provides important protection against future competition and supports the long-term commercial value.

Payer Coverage and J-Code Impact

Payer coverage for PAP-SIMIUS remains exceptional, with an additional 18 million covered lives in Q2 FY26, bringing the total commercial and government coverage to approximately 315 million lives in the U.S. The permanent J-code, effective April 1st, has been particularly important in accelerating adoption, providing a standard reimbursement pathway, streamlining claims processing, and reducing uncertainty for sites. This has helped activate additional accounts and supported continued adoption across academic centers and community practices.

PRGN 2009 and Adenovirus Platform

Precigen is advancing PRGN 2009, an investigational immunotherapy using the same adenovirus platform as PAP-SIMIUS, targeting HPV 16 and HPV 18-related cancers (head and neck, cervical cancers). HPV-related malignancies account for nearly 5% of all cancer cases worldwide. PRGN 2009 is currently in multiple Phase 2 clinical trials in combination with PEMBRO, with updated data for head and neck cancer expected later this year. The success of PAP-SIMIUS and progress of PRGN 2009 establish proof of principle for the Ad-Verse platform, which the company aims to maximize across various indications.

RRP Patient Population and Treatment Approach

The prevalent RRP patient pool in the U.S. is estimated at 27,000. The disease tends to worsen over time, as surgeries do not address the underlying HPV infection. PAP-SIMIUS, by targeting the HPV 6 or 11 driver, offers a differentiated approach. Physicians are increasingly prescribing PAP-SIMIUS earlier in the disease course to prevent irreversible damage, treating patients across all severities, not just the most severe cases, indicating a significant runway for continued growth.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.