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    BMRN
    Earnings call· Jun 2026(Q2 FY26)

    BIOMARIN PHARMACEUTICAL Q2 FY26 earnings call BMRN

    Aug 6, 2026 Source

    Executive summary

    BioMarin Q2 FY26 — Strong Growth, Amicus Integration Exceeds Expectations, VOXZOGO Guidance Raised

    BioMarin delivered a standout second quarter, marked by robust revenue growth and the successful integration of Amicus, which is exceeding initial expectations for peak revenue and synergies. The company raised its full-year guidance for total revenue, VOXZOGO, and non-GAAP EPS, signaling strong momentum into the second half of the year. Strategic pipeline advancements, including a rapid sNDA submission for VOXZOGO in hypochondroplasia, underscore BioMarin's commitment to expanding its leadership in genetic conditions and driving future growth.

    Highlights

    5

    • Total revenue grew 20% year-over-year to nearly $1 billion, driven by a diversified portfolio.

    • VOXZOGO revenue guidance was increased, putting it on a path to become BioMarin's first $1 billion product.

    • Amicus integration is outperforming, with estimated peak revenues of $1.4 billion for Galafold and $1.2 billion for Pombiliti and Opfolda.

    • Significant cost synergies of approximately $220 million annual run rate are expected by 2028 from the Amicus acquisition.

    • Submitted sNDA for VOXZOGO to treat hypochondroplasia in a record 79 days from database lock.

    Concerns

    3

    • Approximately 10% of U.S. VOXZOGO patients switched to a competitor product since its February approval, representing less than 100 patients.

    • Interest expense increased year-over-year due to acquisition debt financing, estimated at approximately $200 million annually.

    • Interest income decreased due to liquidated investments to fund the acquisition.

    Guidance & targets

    18
    CategoryTargetConfidence
    Full-year total revenues
    Raised
    high materiality
    High
    VOXZOGO revenue
    Raised to over $1 billion
    high materiality
    High
    Non-GAAP diluted earnings per share
    Raised
    high materiality
    High
    Galafold peak revenue
    $1.4 billion
    high materiality
    High
    Pombiliti and Opfolda peak revenue
    $1.2 billion
    high materiality
    High
    Amicus annual cost synergies
    $220 million
    high materiality
    High
    Galafold CAGR
    Approximately 10%
    medium materiality
    High
    Pombiliti and Opfolda CAGR
    Greater than or equal to 20%
    medium materiality
    High
    Combined Galafold and Pombiliti and Opfolda non-GAAP operating margin
    Over 60%
    medium materiality
    High
    Deleveraging target
    Approximately 1 year sooner
    medium materiality
    High
    Non-GAAP diluted EPS accretion from Amicus
    Substantial accretion
    high materiality
    High
    BMN 820 Phase III data
    Expected in 2028
    medium materiality
    High
    BMN 333 Phase II enrollment completion
    Expected in 2027
    medium materiality
    High
    Third quarter revenue
    Slightly higher than Q2
    low materiality
    High
    Fourth quarter revenue
    Significantly higher than Q3
    low materiality
    High
    Third quarter non-GAAP EPS
    Slightly higher than Q2
    low materiality
    High
    Fourth quarter non-GAAP EPS
    Significantly higher than Q3
    low materiality
    High
    Amicus synergies realized in 2027
    Half to slightly more than half
    medium materiality
    High

    Segment performance

    5
    SegmentRevenueYoYQoQMargin
    Metabolic Conditions Business Unit
    Total revenue for the newly named business unit, inclusive of Galafold and Pombiliti and Opfolda. Patient numbers grew across all marketed brands year-over-year and sequentially.
    		$695 million25%——
    Galafold (pro forma)
    Pro forma revenue growth year-over-year, driven by increased diagnosis, patient identification, family cascade screening, newborn screening, and reimbursed access.
    		—Approximately 10%——
    Pombiliti and Opfolda (pro forma)
    Pro forma revenue growth year-over-year, driven by patient additions in the U.S. and newly launched geographies, supported by its differentiated clinical profile.
    		—Over 65%——
    PALYNZIQ
    Revenue growth year-over-year, driven by continued patient demand and benefiting from order timing in the U.S. Also benefited from European approval to broaden label to adolescents.
    		—27%——
    VOXZOGO
    Revenue growth driven by double-digit growth in both U.S. and OUS markets. Maintained leadership despite U.S. competitor, with strong traction in the under two age group.
    Global patients treated: >20% year-over-year growthRevenue generated outside U.S.: Approximately 3/4U.S. new patient starts (under two age group): >50%
    		—14%——

    Operational metrics

    12
    Non-GAAP operating margin
    36.4%
    Q2 FY26

    Reported for the second quarter.

    Non-GAAP diluted earnings per share
    $1.20
    Q2 FY26

    Reported for the second quarter.

    Amicus 2025 non-GAAP operating expenses
    $432 million
    FY25

    Baseline for calculating the 50% reduction from synergies.

    Interest expense (annualized)
    $200 million
    Annualized

    Estimated interest expense associated with the acquisition debt financing.

    Interest expense (quarterly)
    $50 million
    Per quarter

    Estimated quarterly interest expense associated with the acquisition debt financing.

    GAAP transaction and integration-related charges
    $84 million
    Q2 FY26

    Included in GAAP SG&A results, excluded from non-GAAP results.

    VOXZOGO sNDA submission time
    79 days
    Q2 FY26

    Time from database lock to filing for VOXZOGO sNDA for hypochondroplasia, noted as easily within top quartile for industry benchmarks.

    FSGS addressable patients
    30,000
    Current

    Estimated addressable patient population for BMN 820 in focal segmental glomerulosclerosis.

    VOXZOGO U.S. patient retention rate
    90%
    As of end of July

    Percentage of U.S. children treated with VOXZOGO who remained on therapy since competitor launch in February.

    Hypochondroplasia global total addressable patient population
    14,000
    Current

    Estimated total addressable patient population for VOXZOGO in hypochondroplasia.

    Achondroplasia U.S. births
    150
    Annual

    Estimated annual births of infants with achondroplasia in the U.S.

    Fabry diagnostic activities and programs
    Almost 50
    Current

    Number of diagnostic activities and programs ongoing globally to improve Fabry diagnosis.

    Industry KPIs

    8
    MetricValueDetails
    Pipeline read out calendarBMN 820 Phase III data in 2028; BMN 333 Phase II completion in 2027
    Product franchise net salesOver $1 billionUSD
    Regulatory approvals filingsVOXZOGO sNDA submitted for hypochondroplasia; PALYNZIQ label expanded in Europe
    Peak long term sales guidanceGalafold $1.4 billion; Pombiliti and Opfolda $1.2 billion; VIMIZIM $1 billionUSD
    Therapeutic drug market share90%%
    Prescription volume new startsOver 50%%
    Clinical trial efficacy safety dataAGV exceeded expectations; statistical significance on height and arm span
    Cumulative patients uptake since launchOver 20%%

    Product announcements

    1
    ProductTypeDetails
    PALYNZIQexpansion

    Deals & partnerships

    3
    Amicus TherapeuticsAcquisition of Amicus Therapeutics to expand BioMarin's portfolio in genetic conditions.

    The acquisition closed in April. Integration is well underway and on track, with the majority of enabling decisions made and operating plans in place. Amicus' commercialization team was retained.

    DimerixPartnership for BMN 820 (formerly DMX-200) for FSGS.

    BioMarin holds exclusive U.S. commercialization rights for BMN 820, while Dimerix remains responsible for operationalizing the Phase III study.

    n-LoremResearch collaboration.

    Mentioned as an example of ongoing research collaborations.

    Risks & headwinds

    5
    VOXZOGO competitive switchingSince February 2026

    Approximately 10% of U.S. patients (less than 100 patients) switched to a competitor since February.

    Mitigation: Focus on VOXZOGO's strong evidence base, safety, efficacy, and exclusive ability to treat patients from birth worldwide. Emphasizing surround sound services and trusted relationships with patients and families.

    ITC case outcomeInitial determination August 21st, final decision December 21st, presidential review until February 21st, 2027.

    Potential for an exclusion order if the commission affirms the initial determination.

    Mitigation: Awaiting the legal process; upon completion, BioMarin expects to enforce its patent in Federal District Court where monetary damages are available.

    Fabry disease underdiagnosisOngoing

    Only approximately 40% of Fabry patients are actually diagnosed; 7-10 years to diagnosis.

    Mitigation: Leveraging BioMarin's diagnostic capabilities, including AI-enabled patient identification, expanded genetic testing, newborn screening, family cascade screening, electronic health record work, and reclassification of variants to shorten time to diagnosis.

    Growth hormone combination with CNP analogsLong-term (3+ years data needed)

    Growth hormone alone causes temporary increases in AGV but not major increases in final adult height; concern that growth hormone may close growth plates early.

    Mitigation: Monitoring data closely and making evidence-based decisions. Emphasizing that the question of long-term health and wellness benefits remains unanswered for combinations.

    Quarterly revenue fluctuations for VIMIZIM and NAGLAZYMEQuarterly

    Order timing was a headwind for VIMIZIM and a slight tailwind for NAGLAZYME in Q2.

    Mitigation: Management emphasizes that full-year metabolic conditions guidance remains the best indicator of expected underlying performance, as patient demand continues to grow.

    What to watch in Q3 FY26

    5

    ITC case initial determination

    August 21st
    CurrentPending
    TargetDecision delivered

    Why it matters

    The initial determination could indicate the potential for an exclusion order, impacting competitive landscape and future legal strategy.

    on the 21st of this month, the 21st of August, the administrative law judge will deliver their initial determination

    Q&A highlights

    6

    Can you provide more detail on the Amicus synergies, especially milestones for 2027, and explain how the deleveraging target was pulled forward?

    Management confirmed the $220 million synergy target for 2028, noting that decisions are made and execution is underway. They expect half to slightly more than half of the synergies to be realized in 2027, contributing to exceeding initial expectations and pulling forward the deleveraging target by approximately one year.

    “next year, we're expecting half to slightly more than half of the synergies to be realized.”

    asked by Christopher Raymond · answered by Brian Mueller

    2 min read5 chapters

    Detailed Narrative

    01

    Amicus Acquisition and Integration Progress

    BioMarin successfully closed and integrated Amicus, with the acquisition demonstrating the company's ability to leverage its scale for rapid integration of high-growth assets. The combined peak revenue potential for Galafold and Pombiliti and Opfolda is estimated at $2.6 billion, alongside significant annual cost synergies of $220 million expected by 2028. These synergies are primarily from G&A, representing a 50% reduction from Amicus' 2025 non-GAAP operating expenses, and are expected to drive substantial non-GAAP EPS accretion starting in 2027 and accelerate deleveraging by approximately one year.

    02

    VOXZOGO Performance and Competitive Dynamics

    VOXZOGO delivered 14% year-over-year revenue growth in Q2, with global patient numbers increasing over 20%. The company raised its full-year VOXZOGO revenue guidance, projecting it to exceed $1 billion. Despite the entry of a U.S. competitor in February, approximately 90% of U.S. VOXZOGO patients remained on therapy as of July. New U.S. patient starts were significantly driven by the under-two age group, where BioMarin holds exclusive approval, reinforcing its leadership in skeletal conditions.

    03

    Metabolic Conditions Business Unit Growth

    The newly named Metabolic Conditions Business Unit, encompassing enzyme therapies and the acquired Amicus medicines, reported $695 million in revenue, growing 25% year-over-year. Galafold and Pombiliti and Opfolda showed strong pro forma growth of approximately 10% and over 65% year-over-year, respectively. PALYNZIQ revenue grew 27% year-over-year, benefiting from order timing and a recent European label expansion for adolescents. Patient demand continues to grow across the portfolio, despite quarterly revenue fluctuations due to order timing for VIMIZIM and NAGLAZYME.

    04

    Pipeline Advancements and Future Growth Drivers

    BioMarin made significant pipeline progress, including the rapid submission of an sNDA for VOXZOGO for hypochondroplasia, shrinking the time from database lock to filing to 79 days. The company also added BMN 820 (formerly DMX-200), a late-stage oral CCR2 inhibitor in Phase III development for focal segmental glomerulosclerosis (FSGS), with data expected in 2028. Enrollment for BMN 333, a gene therapy for achondroplasia, is ongoing, with Phase II completion anticipated in 2027, highlighting BioMarin's commitment to expanding its clinical-stage pipeline.

    05

    Financial Outlook and Capital Allocation

    Second quarter non-GAAP operating margin was 36.4%, with non-GAAP diluted EPS of $1.20. The company expects Q3 revenue to be slightly higher than Q2, and Q4 to be the strongest quarter of the year, driven by Amicus contributions and ordering dynamics. Interest expense increased due to acquisition debt, estimated at $200 million annually. BioMarin plans to expand its clinical-stage pipeline through business development over the next 12 to 18 months, leveraging its strengthened financial profile and cash flow generation.

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