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BioMarin (BMRN) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

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

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

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%——

Product announcements

ProductTypeDetails
PALYNZIQexpansion

Deals & partnerships

Amicus Therapeutics Acquisition 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.

Dimerix Partnership 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-Lorem Research collaboration.

Mentioned as an example of ongoing research collaborations.

Risks & headwinds

VOXZOGO competitive switching Since 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 outcome Initial 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 underdiagnosis Ongoing

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 analogs Long-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 NAGLAZYME Quarterly

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

ITC case initial determination

August 21st
Current Pending
Target Decision 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

Find out whether BMRN delivers this. Inve re-checks your case every morning.

Q&A highlights

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 read 5 chapters

Detailed narrative

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.

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.

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.

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.

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.

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