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    PGEN
    Earnings call· Jun 2026(Q2 FY26)

    PRECIGEN Q2 FY26 earnings call PGEN

    Aug 4, 2026 Source

    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

    5

    • 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

    3
    CategoryTargetConfidence
    Cash flow breakeven
    By the end of 2026
    high materiality
    High
    Gross margins for PAP-SIMIUS
    High 80 percentages to low 90 percentages
    medium materiality
    High
    R&D expenses
    Increase as the year progresses
    low materiality
    High

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    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%—

    Operational metrics

    20
    PAP-SIMIUS revenue growth (QoQ)
    $31.5 millionincreased
    Q2 FY26 vs Q1 FY26

    PAP-SIMIUS revenue grew by $31.5 million from Q1 to Q2, reflecting continued strong demand.

    Cost of products and services
    $2.8 million
    Q2 FY26

    Total cost of products and services for the second quarter.

    Gross margin
    95%
    Q2 FY26

    Gross margin for the second quarter, driven by PAP-SIMIUS sales.

    Research and development cost
    $7.3 milliondecreased by $4.2 million YoY
    Q2 FY26

    R&D costs decreased year-over-year, primarily due to PAP-SIMIUS manufacturing costs being expensed as R&D prior to FDA approval in the prior year.

    Selling, general, and administrative expenses
    $22.2 millionincreased by $6.1 million YoY
    Q2 FY26

    SG&A expenses increased due to higher commercial activities related to PAP-SIMIUS launch.

    Operating income
    $22.6 million
    Q2 FY26

    Operating income for the second quarter.

    Other expense net
    $2.6 million
    Q2 FY26

    Net other expenses for the second quarter, primarily interest expense offset by interest income.

    Interest expense
    $3 million
    Q2 FY26

    Interest expense on $100 million outstanding debt.

    Interest income on investments
    $400,000
    Q2 FY26

    Interest income generated from investments. (Transcription note: ASR error in transcript stated as '$4 million. $400,000', corrected to $400,000 based on context of offsetting $3M interest expense.)

    Cash, cash equivalents, and investments
    $38.7 million
    Q2 FY26 end

    Balance of cash, cash equivalents, and investments at the end of the second quarter.

    Trade accounts receivable
    $71.9 million
    Q2 FY26 end

    Trade accounts receivable balance at quarter end, expected to be collected over the next four months.

    PAP-SIMIUS market exclusivity
    7 years
    from August 2025

    FDA granted PAP-SIMIUS 7-year market exclusivity for adult RRP patients.

    PAP-SIMIUS patient hub registrations
    over 500steady growth
    as of call date

    Total number of patients registered in the Precision Hub, reflecting steady patient identification.

    PAP-SIMIUS covered lives (Q2 addition)
    18 million
    Q2 FY26

    Additional covered lives secured for PAP-SIMIUS in the second quarter.

    PAP-SIMIUS total covered lives
    315 million
    Q2 FY26 end

    Total commercial and government covered lives for PAP-SIMIUS in the U.S. market.

    PAP-SIMIUS patients treated (at least one dose)
    more than 200
    launch to date

    Number of patients who have received at least one dose of PAP-SIMIUS since launch.

    PAP-SIMIUS patients completed treatment
    over 100
    launch to date

    Number of patients who have completed the full course of PAP-SIMIUS treatment.

    RRP prevalent patient pool
    27,000
    US alone

    Estimated number of prevalent Recurrent Respiratory Papillomatosis (RRP) patients in the United States.

    Initial target institutions
    500
    initial targeting

    Number of institutions initially identified as targets, covering over 90% of the RRP patient population.

    Large hospital systems targeted
    100
    initial targeting

    Number of large hospital systems within the initial target, responsible for over 80% of the patient population.

    Industry KPIs

    6
    MetricValueDetails
    Launch access metrics315 millionlives
    Pipeline read out calendarPRGN 2009 head and neck cancer data update
    Regulatory approvals filingsPAP-SIMIUS MAA under review by EMA
    Peak long term sales guidanceBlockbuster potential
    Clinical trial efficacy safety data83%%
    Cumulative patients uptake since launchMore than 200patients

    What to watch in Q3 FY26

    5

    PAP-SIMIUS revenue growth rate

    Q3 FY26
    Current145.8% QoQ ($53.1M in Q2)
    TargetContinued 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.

    Q&A highlights

    5

    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 read5 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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.

    04

    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.

    05

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.