BioMarin Reports First Quarter 2025 Results and Reaffirms Full-year Guidance
- Strong Q1 revenue growth of 15% Y/Y to $745 million
- VOXZOGO revenue surged 40% Y/Y to $214 million
- GAAP Net Income increased 109% Y/Y to $186 million
- Significant margin expansion with GAAP Operating Margin up 16.4 points to 30.0%
- Operating cash flow increased 271% to $174 million
- Positive Phase 3 PALYNZIQ study results for adolescent treatment
- Strong cash position of $1.8 billion
- KUVAN revenue declined 31% Y/Y due to generic competition
- VIMIZIM revenue decreased 3% Y/Y
- Discontinuation of BMN 370 program for von Willebrand disease
Insights
Strong Q1 results with 15% revenue growth and 107% EPS increase demonstrate BioMarin's operational efficiency and commercial momentum across key product lines.
BioMarin delivered exceptional Q1 2025 financial performance across all key metrics. Total revenues reached
The profitability improvements are particularly noteworthy. GAAP operating margin expanded by 16.4 percentage points to 30.0%, while non-GAAP operating margin increased by 11.9 percentage points to 35.7%. This substantial margin expansion stems from both revenue growth and meaningful cost discipline, evidenced by year-over-year reductions in R&D expenses (down 22.6% to
Cash generation has dramatically improved, with operating cash flow of
Management's reaffirmation of full-year guidance (
BioMarin's diversified pipeline advances with VOXZOGO expansion opportunities and positive PALYNZIQ data, while enzyme portfolio shows resilience despite competition.
BioMarin's Q1 results underscore the company's successful execution of its two-pillar strategy focused on Skeletal Conditions and Enzyme Therapies. VOXZOGO continues its impressive commercial trajectory with 40% year-over-year growth to
The VOXZOGO franchise expansion strategy represents a textbook approach to indication expansion. The completed enrollment in the pivotal hypochondroplasia study positions BioMarin for a potential 2027 launch, while the broader CANOPY program targeting idiopathic short stature, Noonan syndrome, Turner syndrome, and SHOX deficiency creates multiple shots on goal. This leverages established commercial infrastructure and scientific expertise in skeletal growth disorders.
The Enzyme Therapies portfolio demonstrated resilience with 8% overall growth despite generic erosion of KUVAN (down 31%). PALYNZIQ's 22% growth and positive Phase 3 data in adolescents support regulatory submissions for label expansion in H2 2025, potentially extending the product's growth runway. The advancement agreement with FDA for BMN 333 (long-acting CNP) creates regulatory clarity for a 2030 approval target.
BioMarin's pipeline prioritization is evident in the discontinuation of BMN 370 for von Willebrand disease, allowing resource reallocation to programs with higher probability of technical and commercial success. The company's R&D strategy appears increasingly focused on leveraging established expertise in rare diseases while pruning programs that don't meet internal thresholds for continued investment.
First Quarter 2025 Total Revenues of
First Quarter 2025 GAAP Diluted Earnings Per Share (EPS) of
First Quarter 2025 Non-GAAP Diluted EPS of
Conference Call and Webcast Scheduled Today at 4:30 p.m. ET
"During the first quarter, we saw continued high demand for our innovative medicines resulting in strong revenue growth and profitability," said Alexander Hardy, President and Chief Executive Officer of BioMarin. "Products in our pipeline also advanced according to plan. In April, we shared positive top-line results from the Phase 3 PALYNZIQ® study for the treatment of adolescents with phenylketonuria between the ages of 12 and 17. Also in April, we were pleased to conclude enrollment in the pivotal study in hypochondroplasia with VOXZOGO, keeping us on track to launch in 2027, should data be supportive."
Mr. Hardy continued, "For the remainder of 2025, we look forward to continued momentum in our global expansion of VOXZOGO® for achondroplasia. Across our Enzyme Therapies, we plan to build upon strong PALYNZIQ performance in the quarter, as well as initiatives to drive uptake of our other therapies to reach an even greater number of patients around the world. In addition to our strong financial outlook, we expect to advance multiple new indications with VOXZOGO in our CANOPY clinical program, share early clinical results from both BMN 351 for Duchenne Muscular dystrophy and BMN 333, our long-acting C-type natriuretic peptide, as well as execute on our business development strategy. We are delivering strong growth and profitability while we continue to implement BioMarin's new strategy and operating model. We look forward to seeing the benefits of this transformation flow through our results in the coming quarters and beyond."
First Quarter 2025 Financial Highlights
- Total Revenues for the first quarter of 2025 were
$745 million 15% compared to the same period in 2024, driven by strong40% year-over-year VOXZOGO revenue growth from new patients initiating therapy across all regions. In the quarter, revenues from BioMarin's Enzyme Therapies (ALDURAZYME®, BRINEURA®, NAGLAZYME®, PALYNZIQ and VIMIZIM®) increased8% compared to the first quarter of 2024, driven by a combination of increased patient demand and the timing of large government orders in all regions. The increase was partially offset by lower KUVAN® product revenues attributed to continued generic competition as a result of the loss of market exclusivity. - GAAP Net Income increased by
$97 million $186 million 109% , primarily attributed to higher gross profit driven by the factors noted above. The increase was also attributed to lower operating expenses following the termination of certain early stage development programs following the company's 2024 strategic portfolio review and focused ROCTAVIAN strategy announced in the second half of 2024. These increases were partially offset by higher tax provision primarily due to increase in taxable income. - Non-GAAP Income increased by
$81 million $221 million 58% growth. The increase in Non-GAAP Income was primarily due to the factors noted above.
First Quarter 2025 Business Highlights
Innovation
- Skeletal Conditions: In March 2025, BioMarin presented new data demonstrating favorable safety and strong adherence in real-world clinical practice with VOXZOGO in children with achondroplasia under the age of 3 years old at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Meeting. No treatment-related adverse events nor any dose interruptions were reported among 63 children followed for up to 23.7 months. These real-world findings further validate VOXZOGO's established safety profile and reinforce the therapeutic benefit seen in clinical studies. The study's safety results, including in infants as young as 1 month old, add to the growing body of evidence supporting early treatment initiation with VOXZOGO, consistent with new international treatment guidelines published in the journal Nature Reviews Endocrinology earlier this year.
- In April 2025, BioMarin completed enrollment in its pivotal Phase 3 study with VOXZOGO in hypochondroplasia and the company is on track to share topline data in 2026, with a potential launch in 2027. BioMarin plans to leverage its multiyear track record treating children with achondroplasia, a related condition, to raise awareness and treat children with hypochondroplasia across the globe. The CANOPY clinical program is continuing to advance VOXZOGO in additional new indications, including idiopathic short stature, Noonan syndrome, Turner syndrome, and SHOX deficiency.
- With BMN 333, BioMarin's long-acting C-type natriuretic peptide (CNP), the company enrolled multiple cohorts of healthy volunteers in its first-in-human study, with initial pharmacokinetic (PK) data expected by year-end. Detailed data from this study is expected to be presented at a scientific forum in the first half of 2026. Pre-clinical data with BMN 333 demonstrated sustained 100 pM concentrations for free CNP, representing an approximate 2-3 fold increase versus published data in an analogous pre-clinical model for other long-acting CNP analogs.
- Additionally, BioMarin recently met with FDA and reached agreement on an overall clinical development plan for BMN 333 in achondroplasia. Assuming the Phase 1 data are supportive, the company plans to initiate a registration-enabling study in 2026, supporting a previously disclosed target for 2030 approval. BioMarin plans to seek similar agreements with additional global regulators in the coming months.
- The company announced in April that its pivotal study with PALYNZIQ for the treatment of adolescents between the ages of 12 and 17 met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels. These data will support the planned submission of applications in the second half of 2025 to expand PALYNZIQ age eligibility in
the United States andEurope . - Other Clinical Pipeline Programs: BMN 351, BioMarin's next generation oligonucleotide for Duchenne Muscular Dystrophy, and BMN 349, an oral therapeutic for Alpha-1 antitrypsin deficiency (AATD)-associated liver disease, continue to advance. Initial data for BMN 351 is anticipated to be presented at a scientific congress in the second half of 2025 (including muscle dystrophin levels from the 6 mg/kg cohort after 25 weeks of dosing).
- During a recent strategic portfolio assessment of R&D programs, BioMarin determined that the evolving profile for BMN 370, a pre-clinical candidate for the treatment of von Willebrand disease, did not meet its threshold for further development and commercialization. The program has been discontinued and impacted employees have been redeployed within BioMarin.
Growth
- Total VOXZOGO revenue in the first quarter increased
40% compared to the same period in 2024, representing continued strong global demand since its commercial launch in 2021. As of the end of the quarter, children with achondroplasia in 49 countries around the world were being treated with VOXZOGO. - In the U.S., BioMarin is investing in focused initiatives to drive continued expansion. These efforts include increasing field personnel to broaden the prescriber base and adding awareness platforms to drive adoption of VOXZOGO treatment. This is expected to begin increasing the rate of
U.S. expansion in the second half of the year. Outside of theU.S. (OUS), from where the majority of VOXZOGO revenue is generated, uneven ordering patterns, consistent with BioMarin's other brands, were observed. This OUS dynamic is expected to result in VOXZOGO full-year revenues being more weighted towards the second half of 2025. - Enzyme Therapies revenues grew
8% in the first quarter Y/Y, driven by strong continued demand for PALYNZIQ. Strong PALYNZIQ performance as well as solid growth from BioMarin's other enzyme treatments are expected to continue throughout 2025.
Value Commitment
- In the first quarter of 2025, BioMarin delivered strong results across the business. Total revenues for the first quarter grew
15% Y/Y. First quarter GAAP Operating Margin of30.0% expanded 16.4 percentage points Y/Y while GAAP Diluted EPS of$0.95 107% Y/Y. First quarter Non-GAAP Operating Margin of35.7% expanded 11.9 percentage points Y/Y while Non-GAAP Diluted EPS of$1.13 59% Y/Y. These measures of profitability increased at rates faster than revenue growth, representing the company's focus on operational efficiency. - During the quarter, BioMarin continued to realize the benefits of cost transformation initiatives implemented in 2024, resulting in a decrease in GAAP and Non-GAAP R&D and SG&A expenses Y/Y. Throughout the remainder of 2025, BioMarin expects to increase investments in VOXZOGO indication expansion, clinical pipeline development, and commercialization initiatives supporting the company's Skeletal Conditions and Enzyme Therapies business units.
- The company generated operating cash flows totaling
$174 million 271% compared to first quarter 2024. Total cash and investments at the end of the first quarter were approximately$1.8 billion - Today, the company reaffirmed its previously communicated 2025 full-year financial guidance, which reflects the impact of tariffs that have already been enacted but does not reflect the impact of potential future pharmaceutical tariffs. BioMarin has immaterial exposure to
U.S. tariffs forChina ,Mexico andCanada across its global supply chain operations and product sales.
Financial Highlights (in millions of | ||||||
Three Months Ended March 31, | ||||||
2025 | 2024 | % Change | ||||
Total Revenues | 15 % | |||||
Net Product Revenues by Product: | ||||||
VOXZOGO | 40 % | |||||
Enzyme Therapies: | ||||||
VIMIZIM | (3) % | |||||
NAGLAZYME | 114 | 106 | 8 % | |||
PALYNZIQ | 93 | 76 | 22 % | |||
ALDURAZYME | 49 | 35 | 40 % | |||
BRINEURA | 40 | 39 | 3 % | |||
Total Enzyme Therapies Revenue | 8 % | |||||
KUVAN | (31) % | |||||
ROCTAVIAN® | 1,000 % | |||||
GAAP Net Income | 109 % | |||||
Non-GAAP Income (1) | 58 % | |||||
GAAP Operating Margin % (2) | 30.0 % | 13.6 % | ||||
Non-GAAP Operating Margin % (1) | 35.7 % | 23.8 % | ||||
GAAP Diluted Earnings per Share (EPS) | 107 % | |||||
Non-GAAP Diluted EPS (1) | 59 % | |||||
March 31, | December 31, | ||
Total cash, cash equivalents & investments | $ 1,779 | $ 1,659 |
(1) | Refer to Non-GAAP Information beginning on page 10 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 |
(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
BioMarin does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the company is unable to predict with reasonable certainty the financial impact of changes resulting from its strategic portfolio and business operating model reviews; potential future asset impairments; gains and losses on investments; and other unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. As such, any reconciliations provided would imply a degree of precision that could be confusing or misleading to investors.
2025 Full-Year Financial Guidance (in millions, except % and EPS amounts)
Item | 2025 Guidance Reaffirmed | |||||
Total Revenues (1) | to | |||||
Non-GAAP Operating Margin % (2) | 32 % | to | 33 % | |||
Non-GAAP Diluted EPS (2)(3) | to | |||||
(1) | VOXZOGO contribution to full-year 2025 Total Revenues expected to be in the range of |
(2) | Refer to Non-GAAP Information beginning on page 10 of this press release for definitions of Non-GAAP Operating Margin and Non-GAAP Diluted EPS. |
(3) | Non-GAAP Diluted EPS guidance assumes approximately 200 million Weighted-Average Diluted Shares Outstanding. |
BioMarin will host a conference call and webcast to discuss first quarter 2025 financial results today, Thursday, May 1, 2025, at 4:30 p.m. ET. This event can be accessed through this link or on the investor section of the BioMarin website at www.biomarin.com.
Replay Dial-in Number: 800-770-2030 | |
International Dial-in Number: 646-968-2525 | Replay International Dial-in Number: 609-800-9909 |
Conference ID: 4327591 | Conference ID: 4327591 |
About BioMarin
BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The
Forward-Looking Statements
This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: future financial performance, including the expectations of Total Revenues, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS and Operating Cash Flow for, in certain instances, the full-year 2025 and future periods, as well as profitability growth in 2025, and the underlying drivers of those results, such as the revenue opportunity represented by treatments for Skeletal Conditions, namely VOXZOGO, the expected demand and continued growth of BioMarin's Enzyme Therapies portfolio, including PALYNZIQ, and the expectation regarding the full realization of the benefits of BioMarin's cost transformation program; plans regarding BioMarin's revamped corporate strategy and operating model in 2025 and beyond, including expected growth in the Skeletal Conditions business unit and execution of BioMarin's business development strategy, and its anticipated benefits; the timing of orders for commercial products; BioMarin's ability to meet product demand; the timing of BioMarin's clinical development and commercial prospects, including announcements of data from clinical studies and trials; the clinical development and commercialization of BioMarin's product candidates and commercial products, including (i) expected advancements of pipeline candidates, including BMN 333, BMN 349 and BMN 351, the anticipated initial data read-out for BMN 351 in the second half of 2025, the expected data and data presentation for BMN 333 in the first half of 2026 and plans to initiate a registration-enabling study for BMN 333 in 2026, as well as plans to seek similar agreements with additional global regulators in the coming months; (ii) plans to submit applications to expand PALYNZIQ age eligibility for the treatment of adolescents with phenylketonuria between the ages of 12 and 17 in the
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: BioMarin's success in the commercialization of its commercial products; impacts of macroeconomic and other external factors on BioMarin's operations, such as trade wars and potential future pharmaceutical tariffs; results and timing of current and planned preclinical studies and clinical trials and the release of data from those trials; BioMarin's ability to successfully manufacture its commercial products and product candidates; the content and timing of decisions by the
BioMarin®, BRINEURA®, KUVAN®, NAGLAZYME®, PALYNZIQ®, ROCTAVIAN®, VIMIZIM® and VOXZOGO® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. ALDURAZYME® is a registered trademark of BioMarin/Genzyme LLC. All other brand names and service marks, trademarks and other trade names appearing in this release are the property of their respective owners.
Contact: | ||
Investors: | Media: | |
Traci McCarty | Marni Kottle | |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
(415) 455-7558 | (650) 374-2803 |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||
Three Months Ended March 31, 2025 and 2024 | |||
(In thousands of | |||
(Unaudited) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
REVENUES: | |||
Net product revenues | $ 734,644 | $ 637,815 | |
Royalty and other revenues | 10,501 | 11,018 | |
Total revenues | 745,145 | 648,833 | |
OPERATING EXPENSES: | |||
Cost of sales | 151,558 | 125,180 | |
Research and development | 158,731 | 204,987 | |
Selling, general and administrative | 206,116 | 225,906 | |
Intangible asset amortization | 4,847 | 14,298 | |
Gain on sale of nonfinancial assets | — | (10,000) | |
Total operating expenses | 521,252 | 560,371 | |
INCOME FROM OPERATIONS | 223,893 | 88,462 | |
Interest income | 19,013 | 19,365 | |
Interest expense | (2,863) | (3,547) | |
Other income (expense), net | (1,954) | 1,267 | |
INCOME BEFORE INCOME TAXES | 238,089 | 105,547 | |
Provision for income taxes | 52,403 | 16,885 | |
NET INCOME | $ 185,686 | $ 88,662 | |
EARNINGS PER SHARE, BASIC | $ 0.97 | $ 0.47 | |
EARNINGS PER SHARE, DILUTED | $ 0.95 | $ 0.46 | |
Weighted average common shares outstanding, basic | 190,967 | 188,866 | |
Weighted average common shares outstanding, diluted | 196,474 | 199,262 | |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
March 31, 2025 and 2024 | |||
(In thousands of | |||
(Unaudited) | |||
March 31, 2025 | December 31, 2024 ⁽¹⁾ | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 1,048,803 | $ 942,842 | |
Short-term investments | 223,532 | 194,864 | |
Accounts receivable, net | 739,177 | 660,535 | |
Inventory | 1,274,848 | 1,232,653 | |
Other current assets | 181,545 | 201,533 | |
Total current assets | 3,467,905 | 3,232,427 | |
Noncurrent assets: | |||
Long-term investments | 506,724 | 521,238 | |
Property, plant and equipment, net | 1,032,613 | 1,043,041 | |
Intangible assets, net | 247,346 | 255,278 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,460,566 | 1,489,366 | |
Other assets | 235,654 | 251,391 | |
Total assets | $ 7,147,007 | $ 6,988,940 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 628,213 | $ 606,988 | |
Total current liabilities | 628,213 | 606,988 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 595,650 | 595,138 | |
Other long-term liabilities | 129,685 | 128,824 | |
Total liabilities | 1,353,548 | 1,330,950 | |
Stockholders' equity: | |||
Common stock, | 192 | 191 | |
Additional paid-in capital | 5,794,302 | 5,802,068 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (11,177) | (11,227) | |
Accumulated other comprehensive income (loss) | 19,151 | 61,653 | |
Accumulated deficit | (9,009) | (194,695) | |
Total stockholders' equity | 5,793,459 | 5,657,990 | |
Total liabilities and stockholders' equity | $ 7,147,007 | $ 6,988,940 | |
(1) | December 31, 2024 balances were derived from the audited Consolidated Financial Statements included in the company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 24, 2025. |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
Three Months Ended March 31, 2025 and 2024 | |||
(In thousands of | |||
(Unaudited) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income | $ 185,686 | $ 88,662 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 22,069 | 27,350 | |
Non-cash interest expense | 660 | 990 | |
Accretion of discount on investments | (1,362) | (2,502) | |
Stock-based compensation | 37,700 | 58,249 | |
Gain on sale of nonfinancial assets | — | (10,000) | |
Impairment of assets | 2,967 | — | |
Deferred income taxes | 28,429 | 285 | |
Unrealized foreign exchange gain | (10,026) | (10,804) | |
Other | (1,267) | 127 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (57,590) | (3,386) | |
Inventory | (24,335) | (16,820) | |
Other current assets | (6,327) | (17,353) | |
Other assets | (1,624) | (12,130) | |
Accounts payable and accrued liabilities | (2,655) | (59,006) | |
Other long-term liabilities | 2,069 | 3,309 | |
Net cash provided by operating activities | 174,394 | 46,971 | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (16,768) | (26,104) | |
Maturities and sales of investments | 77,804 | 131,533 | |
Purchases of investments | (89,274) | (121,665) | |
Proceeds from sale of nonfinancial assets | — | 10,000 | |
Purchase of intangible assets | — | (8,000) | |
Net cash used in investing activities | (28,238) | (14,236) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | — | 7,197 | |
Taxes paid related to net share settlement of equity awards | (38,779) | (49,948) | |
Other | — | (42) | |
Net cash used in financing activities | (38,779) | (42,793) | |
Effect of exchange rate changes on cash | (1,416) | 1,927 | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 105,961 | (8,131) | |
Cash and cash equivalents: | |||
Beginning of period | $ 942,842 | $ 755,127 | |
End of period | $ 1,048,803 | $ 746,996 | |
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 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 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 and convertible debt in periods when they are dilutive under Non-GAAP. The company's presentation of percentage changes in total revenues at Constant Currency rates, which is computed using current period local currency sales at the prior period's foreign exchange rates, is also a Non-GAAP financial measure. This measure provides information about growth (or declines) in the company's total revenue as if foreign currency exchange rates had not changed between the prior period and the current period.
BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities: the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income, Non-GAAP R&D expenses, Non-GAAP SG&A expenses, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS, Non-GAAP Weighted-Average Diluted Shares Outstanding and Constant Currency are important internal measurements for BioMarin, the company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's principal business. BioMarin also uses Non-GAAP Income internally to understand, manage and evaluate its business and to make operating decisions, and compensation of executives is based in part on this measure.
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 BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following tables present the reconciliation of GAAP reported to Non-GAAP adjusted financial information:
Reconciliation of GAAP Reported Information to Non-GAAP Information (1) | |||
(In millions of | |||
(unaudited) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
GAAP Reported Net Income | $ 186 | $ 89 | |
Adjustments | |||
Stock-based compensation expense - COS | 2 | 3 | |
Stock-based compensation expense - R&D | 12 | 21 | |
Stock-based compensation expense - SG&A | 23 | 34 | |
Amortization of intangible assets | 5 | 14 | |
Gain on sale of nonfinancial assets (2) | — | (10) | |
Severance and restructuring costs (3) | — | 3 | |
Loss on investments (4) | 3 | — | |
Income tax effect of adjustments | (10) | (15) | |
Non-GAAP Income | $ 221 | $ 140 | |
Three Months Ended March 31, | |||||||
2025 | 2024 | ||||||
Dollar | Percentage | Dollar | Percentage | ||||
GAAP Change in Total Revenues | $ 96 | 15 % | $ 52 | 9 % | |||
Adjustment for unfavorable impact of foreign currency exchange rates on product sales denominated in currencies other than | 14 | 23 | |||||
Non-GAAP change in Total Revenues at Constant Currency | $ 110 | 17 % | $ 75 | 13 % | |||
Three Months Ended March 31, | |||||||
2025 | 2024 | ||||||
R&D | SG&A | R&D | SG&A | ||||
GAAP expenses | $ 159 | $ 206 | $ 205 | $ 226 | |||
Adjustments | |||||||
Stock-based compensation expense | (12) | (23) | (21) | (34) | |||
Severance and restructuring costs (3) | — | — | — | (3) | |||
Non-GAAP expenses | $ 147 | $ 183 | $ 184 | $ 188 | |||
Three Months Ended March 31, | ||||
2025 | Percent | 2024 | Percent | |
GAAP Income from Operations | $ 224 | 30.0 % | $ 88 | 13.6 % |
Adjustments | ||||
Stock-based compensation expense | 37 | 5.0 | 58 | 9.0 |
Amortization of intangible assets | 5 | 0.7 | 14 | 2.2 |
Gain on sale of nonfinancial assets (2) | — | — | (10) | (1.5) |
Severance and restructuring costs (3) | — | — | 3 | 0.5 |
Non-GAAP Income from Operations | $ 266 | 35.7 % | $ 154 | 23.8 % |
Three Months Ended March 31, | |||
2025 | 2024 | ||
GAAP Diluted EPS | $ 0.95 | $ 0.46 | |
Adjustments | |||
Stock-based compensation expense | 0.19 | 0.29 | |
Amortization of intangible assets | 0.03 | 0.07 | |
Gain on sale of nonfinancial assets (2) | — | (0.05) | |
Severance and restructuring costs (3) | — | 0.02 | |
Loss on investments (4) | 0.02 | — | |
Income tax effect of adjustments | (0.05) | (0.08) | |
Non-GAAP Diluted EPS (5) | $ 1.13 | $ 0.71 | |
(1) | Certain amounts may not sum or recalculate due to rounding. |
(2) | Represents a payment triggered by a third party's attainment of a regulatory approval milestone related to previously sold intangible assets. |
(3) | These amounts were included in SG&A and represent severance and restructuring costs related to the Company's 2024 corporate initiatives and the associated organizational redesign efforts. |
(4) | Represents an impairment loss on non-marketable equity securities recorded in Other income (expense), net. |
(5) | Non-GAAP Weighted-Average Diluted Shares Outstanding were 196.5 million and 199.3 million shares for the three months ended March 31, 2025 and 2024, respectively, which were equal to the respective GAAP Weighted-Average Diluted Shares Outstanding in the periods presented. |
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SOURCE BioMarin Pharmaceutical Inc.
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