BioMarin Reports First Quarter 2026 Financial and Operating Results
First Quarter 2026 Total Revenues Increased Year-over-year to
Increased Full-year 2026 Total Revenues Guidance to between
Conference Call and Webcast Scheduled Today at
"With the acquisition of Amicus Therapeutics complete, the addition of GALAFOLD and POMBILITI + OPFOLDA to our commercial portfolio allows us to reach patients with Fabry and Pompe diseases and meaningfully strengthens and accelerates our near-to-mid-term growth rates," said
2026 Business and Pipeline Highlights
Innovation
- In February,
U.S. FDA approved PALYNZIQ® for adolescents 12 years of age and older with phenylketonuria (PKU); EU approval for adolescents 12 years of age and older is expected in 2026. - In March, the company presented initial Phase 1/2 data for BMN 351 at the
Muscular Dystrophy Association (MDA) Clinical & Scientific Congress demonstrating dose-dependent increases in dystrophin expression at Week 25 biopsy in both the 6 and 9 mg/kg dose cohorts. Clinical biomarkers, including decreases in creatine kinase, suggested improvements in overall muscle health beyond the Week 25 time point, and longer-term outcomes from both NSAA and 6MWT suggested a prevention of functional decline when compared to historical matched controls. The 12 mg/kg dose cohort continues to enroll, with a data update expected by year-end. - In April, the first patient was enrolled in the registration-enabling Phase 2/3 study of BMN 333,
BioMarin's long-acting C-type natriuretic peptide (CNP) for achondroplasia. A data update from this study is expected in 2027. - In April, the company submitted its
U.S. supplemental new drug application (sNDA) for full approval of VOXZOGO® for achondroplasia. The company expects to be notified of sNDA acceptance by Q3 2026. - In May, at the
Pediatric Endocrine Society's (PES) annual meeting,BioMarin reported new data demonstrating the benefits of long-term treatment with VOXZOGO, including improvements in arm span, bone health, and quality of life. Data from ongoing long-term extension clinical trials showed that children who initiated VOXZOGO treatment after age 5 achieved mean height gains of +10.60cm after six years and +13.59cm (p<0.0001 for both) after eight years of treatment, as compared to natural history data. - In the second quarter,
BioMarin expects to share BMN 401 Phase 3 topline data in children ages 1-to-12 year-old with ENPP1 deficiency. Regulatory submissions are anticipated in 2H'26 should the data be supportive, with a potential first-in-disease launch in 2027. - In the second quarter, the company expects to share Phase 3 topline data for VOXZOGO for hypochondroplasia. Regulatory submissions are anticipated in 2H'26 should the data be supportive, with a potential first-in-class launch in 2027. Enrollment is progressing in the Phase 2 study of VOXZOGO in children under 3 years old with hypochondroplasia.
Growth
- Increased full-year 2026 Total Revenues guidance, accelerating anticipated growth rate to 20% Y/Y, as a result of the addition of GALAFOLD for Fabry disease and POMBILITI + OPFOLDA to
BioMarin's commercial portfolio. - Enzyme Therapies revenue grew 6% Y/Y in the first quarter, driven by revenue growth for VIMIZIM®, NAGLAZYME®, and BRINEURA®. Continued underlying patient demand in Q1 for PALYNZIQ was driven by an increase in enrollments and new starts in the under-18-year age group following label expansion in February. PALYNZIQ revenue is expected to increase over time with continued patient demand and as new adult and adolescent patients titrate up to maintenance dosing. As a result, full-year 2026 PALYNZIQ revenue is expected to increase year-over-year.
- The number of children being treated with VOXZOGO increased by more than 20% Y/Y in the first quarter. As expected, large VOXZOGO orders in fourth quarter of 2025 resulted in modest Y/Y growth of 3% in the first quarter of 2026.
Value Commitment
- During the first quarter, the company secured financing of approximately
$3.7 billion of non-convertible debt to support the Amicus acquisition, achieving favorable pricing across the capital structure. -
BioMarin generated operating cash flows totaling$221 million in first quarter 2026. Total cash was approximately$2 billion as of the end of the quarter, and continued increasing operating cash flow is expected to support sustained investment in innovation and future growth.
First Quarter 2026 Financial Highlights
-
Total Revenues for the first quarter of 2026 were
$766 million , an increase of $21 million compared to the same period in 2025, primarily driven by timing of large government orders outside theU.S. and increase in patient demand for Enzyme Therapies (ALDURAZYME®, BRINEURA, NAGLAZYME, PALYNZIQ and VIMIZIM) as well as new patients initiating VOXZOGO therapy across all regions. The increase was partially offset by lower ROCTAVIAN® revenue attributed to voluntary withdrawal of the product from the market announced in the first quarter of 2026. -
GAAP Net Income for the first quarter of 2026 decreased to
$106 million compared to$186 million for the same period in 2025. The decrease in GAAP Net Income was primarily attributed to the following:- higher Selling, General & Administrative (SG&A) spend primarily due to incremental administrative costs related to ongoing support of corporate initiatives and pre-close costs for Amicus acquisition, and higher sales and marketing spend on VOXZOGO, PALYNZIQ and VIMIZIM;
- higher Cost of Sales primarily due to a
$31 million charge associated with an unsuccessful process qualification campaign to expand NAGLAZYME manufacturing capabilities; - higher Research and Development spend to support BMN 401, a late-stage clinical program acquired in the third quarter of 2025;
- partially offset by revenue growth as mentioned above.
-
Non-GAAP Income for the first quarter of 2026 decreased to
$149 million compared to$221 million for the same period in 2025. The decrease in Non-GAAP Income was primarily due to the factors noted above. -
GAAP Diluted Earnings per Share (EPS) and Non‑GAAP Diluted EPS for the first quarter of 2026 decreased compared to the same period in 2025, primarily reflecting the discrete items and higher operating expenses described above. The $31 million charge in Cost of Sales related to the NAGLAZYME campaign reduced EPS by approximately
$0.12 year‑over‑year. In addition, pre‑close integration preparation costs recorded in SG&A and interest expense associated with the Amicus transaction reduced EPS by approximately$0.07 .
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Financial Highlights (in millions of |
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Three Months Ended
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2026 |
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2025 |
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% Change |
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Total Revenues |
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3 % |
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Net Product Revenues by Product: |
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VOXZOGO |
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3 % |
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Enzyme Therapies: |
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VIMIZIM |
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12 % |
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NAGLAZYME |
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130 |
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114 |
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14 % |
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PALYNZIQ |
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90 |
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93 |
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(3) % |
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BRINEURA |
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47 |
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40 |
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18 % |
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ALDURAZYME |
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37 |
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49 |
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(24) % |
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Total Enzyme Therapies Revenue |
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6 % |
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KUVAN ® |
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(4) % |
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ROCTAVIAN |
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(73) % |
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GAAP Net Income |
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(43) % |
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Non-GAAP Income (1) |
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(33) % |
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GAAP Operating Margin % (2) |
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16.9 % |
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30.0 % |
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Non-GAAP Operating Margin % (1) |
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24.3 % |
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35.7 % |
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GAAP Diluted EPS |
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(43) % |
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Non-GAAP Diluted EPS (1) |
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(33) % |
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(1) |
Refer to Non-GAAP Information beginning on page 9 of this press release for definitions of Non-GAAP Income, Non-GAAP Operating Margin percentage and Non-GAAP Diluted EPS along with the related reconciliations to the comparable information reported under |
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(2) |
GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations divided by Total Revenues. |
Forward-Looking Non-GAAP Financial Information
Updated 2026 Full-Year Financial Guidance (in millions, except EPS amounts)
- Updated guidance reflects post-close contributions from Amicus beginning
April 27, 2026 . - As previously communicated, the acquisition of Amicus is expected to be slightly dilutive to full-year 2026 Non‑GAAP Diluted EPS; historical BioMarin Non-GAAP Diluted EPS guidance is unchanged.
- The Amicus acquisition will be accounted for as a business combination, which will result in intangible amortization impacting GAAP results over future periods and excluded from Non‑GAAP results.
BioMarin will continue to include interest expense related to the Amicus financing in both GAAP and Non‑GAAP financial results. Guidance is subject to change based on various factors including finalization of purchase accounting. - The company expects approximately two-thirds of 2026 Non-GAAP Diluted EPS to be recognized in the second half of 2026, primarily due to the anticipated timing of revenue (more than 55% of 2026 Total Revenues is expected in 2H). Non-GAAP Diluted EPS in Q2 is expected to be modestly higher than in Q1.
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Item |
Provided on |
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Updated May 4, 2026 |
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Total Revenues |
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to |
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to |
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Enzyme Therapies |
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to |
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to |
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VOXZOGO |
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to |
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Unchanged |
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Other Revenues(1) |
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to |
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Unchanged |
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Non-GAAP Diluted EPS (2)(3)(4) |
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to |
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to |
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(1) |
Other Revenues includes KUVAN, ROCTAVIAN, and royalties. |
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(2) |
Refer to Non-GAAP Information beginning on page 9 of this press release for definition of Non-GAAP Diluted EPS. |
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(3) |
Non-GAAP Diluted EPS guidance assumes approximately 200 million Weighted-Average Diluted Shares Outstanding. |
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(4) |
Non-GAAP Diluted EPS guidance assumes a combined company tax rate of 22%, which is subject to change as the company completes its integration activities and purchase accounting. |
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International Dial-in Number: 646-307-1963 |
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Conference ID: 3424435 |
Conference ID: 3424435 |
About
Forward-Looking Statements
This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of
These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others:
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
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Three Months Ended |
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(In thousands of |
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(Unaudited) |
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Three Months Ended
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2026 |
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2025 |
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REVENUES: |
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Net product revenues |
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$ 760,078 |
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$ 734,644 |
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Royalty and other revenues |
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6,130 |
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10,501 |
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Total revenues |
|
766,208 |
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745,145 |
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OPERATING EXPENSES: |
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Cost of sales |
|
194,999 |
|
151,558 |
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Research and development |
|
178,796 |
|
158,731 |
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Selling, general and administrative |
|
258,290 |
|
206,116 |
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Intangible asset amortization |
|
4,483 |
|
4,847 |
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Total operating expenses |
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636,568 |
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521,252 |
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INCOME FROM OPERATIONS |
|
129,640 |
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223,893 |
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|
|
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Interest income |
|
22,560 |
|
19,013 |
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Interest expense |
|
(14,958) |
|
(2,863) |
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Other income (expense), net |
|
3,961 |
|
(1,954) |
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INCOME BEFORE INCOME TAXES |
|
141,203 |
|
238,089 |
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Provision for income taxes |
|
35,676 |
|
52,403 |
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NET INCOME |
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$ 105,527 |
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$ 185,686 |
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EARNINGS PER SHARE, BASIC |
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$ 0.55 |
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$ 0.97 |
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EARNINGS PER SHARE, DILUTED |
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$ 0.54 |
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$ 0.95 |
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Weighted average common shares outstanding, basic |
|
192,497 |
|
190,967 |
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Weighted average common shares outstanding, diluted |
|
197,671 |
|
196,474 |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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March 31, 2026 and 2025 |
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(In thousands of |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ 2,222,435 |
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$ 1,311,679 |
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Short-term investments |
— |
|
248,930 |
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Accounts receivable, net |
903,914 |
|
908,214 |
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Inventory |
1,273,221 |
|
1,298,883 |
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Other current assets |
205,500 |
|
185,784 |
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Total current assets |
4,605,070 |
|
3,953,490 |
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Noncurrent assets: |
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Long-term investments |
— |
|
492,242 |
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Property, plant and equipment, net |
958,071 |
|
952,508 |
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Intangible assets, net |
204,662 |
|
213,837 |
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|
196,199 |
|
196,199 |
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Deferred tax assets |
1,500,598 |
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1,508,697 |
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Restricted cash equivalents |
850,000 |
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— |
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Other assets |
276,416 |
|
277,049 |
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Total assets |
$ 8,591,016 |
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$ 7,594,022 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
$ 793,152 |
|
$ 759,031 |
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Total current liabilities |
793,152 |
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759,031 |
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Noncurrent liabilities: |
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Long-term debt, net |
1,430,282 |
|
597,176 |
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Other long-term liabilities |
155,475 |
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150,816 |
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Total liabilities |
2,378,909 |
|
1,507,023 |
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Stockholders' equity: |
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Common stock, |
193 |
|
192 |
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Additional paid-in capital |
5,966,868 |
|
5,956,582 |
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Company common stock held by the Nonqualified Deferred Compensation Plan |
(10,450) |
|
(10,508) |
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Accumulated other comprehensive income (loss) |
(4,237) |
|
(13,473) |
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Retained earnings |
259,733 |
|
154,206 |
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Total stockholders' equity |
6,212,107 |
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6,086,999 |
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Total liabilities and stockholders' equity |
$ 8,591,016 |
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$ 7,594,022 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
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Three Months Ended |
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(In thousands of |
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(Unaudited) |
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Three Months Ended |
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2026 |
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2025 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net income |
$ 105,527 |
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$ 185,686 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
16,411 |
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22,069 |
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Non-cash interest expense |
6,086 |
|
660 |
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Accretion of discount on investments |
(455) |
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(1,362) |
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Stock-based compensation |
43,458 |
|
37,700 |
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Impairment of assets |
— |
|
2,967 |
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Deferred income taxes |
9,220 |
|
28,429 |
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Unrealized foreign exchange losses (gains) |
6,710 |
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(10,026) |
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Other |
(5,374) |
|
(1,267) |
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Changes in operating assets and liabilities: |
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|
|
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Accounts receivable, net |
(7,159) |
|
(57,590) |
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Inventory |
44,490 |
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(24,335) |
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Other current assets |
(11,551) |
|
(6,327) |
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Other assets |
1,484 |
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(1,624) |
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Accounts payable and accrued liabilities |
3,100 |
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(2,655) |
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Other long-term liabilities |
8,704 |
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2,069 |
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Net cash provided by operating activities |
220,651 |
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174,394 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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|
|
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Purchases of property, plant and equipment |
(20,923) |
|
(16,768) |
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Maturities and sales of investments |
767,277 |
|
77,804 |
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Purchases of investments |
(25,792) |
|
(89,274) |
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Other |
4,966 |
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— |
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Net cash provided by (used in) investing activities |
725,528 |
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(28,238) |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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|
|
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Taxes paid related to net share settlement of equity awards |
(28,180) |
|
(38,779) |
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Proceeds from issuance of debt |
850,000 |
|
— |
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Payments of debt issuance costs |
(8,653) |
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— |
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Net cash provided by (used in) financing activities |
813,167 |
|
(38,779) |
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Effect of exchange rate changes on cash |
1,410 |
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(1,416) |
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NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
1,760,756 |
|
105,961 |
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Cash, cash equivalents and restricted cash equivalents: |
|
|
|
|
Beginning of period |
$ 1,311,679 |
|
$ 942,842 |
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End of period |
$ 3,072,435 |
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$ 1,048,803 |
Non-GAAP Information
The results presented in this press release include both GAAP information and Non-GAAP information. Non-GAAP Income is defined by the company as GAAP Net Income (Loss) excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items, as detailed below when applicable. The company also includes a Non-GAAP adjustment for the estimated tax impact of the reconciling items. Non-GAAP R&D expenses and Non-GAAP SG&A expenses are defined by the company as GAAP R&D expenses and GAAP SG&A expenses, respectively, excluding stock-based compensation expense and, in certain periods, certain other specified items, as detailed below when applicable. Non-GAAP Operating Margin percentage is defined by the company as GAAP Income (Loss) from Operations, excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items, divided by GAAP Total Revenues. Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income divided by Non-GAAP Weighted-Average Diluted Shares Outstanding. Non-GAAP Weighted-Average Diluted Shares Outstanding is defined by the company as GAAP Weighted-Average Diluted Shares Outstanding, adjusted to include any common shares issuable under the company's equity plans or convertible debt in periods when they are dilutive under Non-GAAP.
Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its Non-GAAP financial measures; likewise, the company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Because of the non-standardized definitions, the Non-GAAP financial measure as used by
The following tables present the reconciliation of GAAP reported to Non-GAAP adjusted financial information:
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Reconciliation of GAAP Reported Information to Non-GAAP Information (1) |
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(In millions of |
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(unaudited) |
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Three Months Ended
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2026 |
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2025 |
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GAAP Reported Net Income |
$ 106 |
|
$ 186 |
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Adjustments |
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Stock-based compensation expense - COS |
4 |
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2 |
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Stock-based compensation expense - R&D |
12 |
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12 |
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Stock-based compensation expense - SG&A |
28 |
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23 |
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Amortization of intangible assets |
4 |
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5 |
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Severance costs (2) |
8 |
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— |
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Loss on investments (3) |
— |
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3 |
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Income tax effect of adjustments |
(13) |
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(10) |
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Non-GAAP Income |
$ 149 |
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$ 221 |
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Three Months Ended
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2026 |
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2025 |
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R&D |
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SG&A |
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R&D |
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SG&A |
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GAAP expenses |
$ 179 |
|
$ 258 |
|
$ 159 |
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$ 206 |
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Adjustments |
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Stock-based compensation expense |
(12) |
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(28) |
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(12) |
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(23) |
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Severance costs (2) |
— |
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(8) |
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— |
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— |
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Non-GAAP expenses |
$ 167 |
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$ 222 |
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$ 147 |
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$ 183 |
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Three Months Ended
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2026 |
Percent |
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2025 |
Percent |
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GAAP Income from Operations |
$ 130 |
16.9 % |
|
$ 224 |
30.0 % |
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Adjustments |
|
|
|
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Stock-based compensation expense |
44 |
5.7 |
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37 |
5.0 |
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Amortization of intangible assets |
4 |
0.5 |
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5 |
0.7 |
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Severance costs (2) |
8 |
1.0 |
|
— |
— |
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Non-GAAP Income from Operations |
$ 186 |
24.3 % |
|
$ 266 |
35.7 % |
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Three Months Ended
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2026 |
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2025 |
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GAAP Diluted EPS |
$ 0.54 |
|
$ 0.95 |
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Adjustments |
|
|
|
|
Stock-based compensation expense |
0.22 |
|
0.19 |
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Amortization of intangible assets |
0.02 |
|
0.03 |
|
Severance costs (2) |
0.04 |
|
— |
|
Loss on investments (3) |
— |
|
0.02 |
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Income tax effect of adjustments |
(0.07) |
|
(0.05) |
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Non-GAAP Diluted EPS(4) |
$ 0.76 |
|
$ 1.13 |
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(1) |
Certain amounts may not sum or recalculate due to rounding. |
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(2) |
These amounts were included in SG&A and represent charges for severance in connection with the company's plan to simplify its organizational design and strategic initiatives in the first quarter of 2026. |
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(3) |
Represents impairment loss on non-marketable equity securities recorded in Other income (expense), net, in the first quarter of 2025. |
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(4) |
Both GAAP and Non-GAAP Weighted-Average Diluted Shares Outstanding were 197.7 million and 196.5 million shares for the three months ended |
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Contact: |
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Investors: |
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Media: |
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(415) 455-7558 |
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(650) 374-2803 |
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