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BIOMARIN PHARMACEUTICAL INC

For the period ended Sep 30, 2025. Filed Oct 28, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Oct 28, 2025

BMRN$56.03-0.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-05.

0001048477-25-000090

Item 2. Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-10-28.

0001048477-25-000107

Item 2. Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 72 previous paragraphs and 76 current paragraphs.

47 unchanged; 20 reworded; 5 added; 5 removed; 0 previous and 4 current paragraphs rearranged.

Tables are not compared: 15 previous and 15 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

•VOXZOGO and PALYNZIQ: higher sales volume from new patients initiating therapy across all regions.

Current report

Cost of Sales decreased in the three months ended September 30, 2025 as compared to the three months ended September 30, 2024, primarily due to favorable product mix resulting from lower per-unit manufacturing costs and reduced ROCTAVIAN inventory reserves. Gross margin increased during the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024, primarily due to higher sales volume for products with higher margin in our Enzyme Therapies portfolio.

Current report

Other Income, Net

Current report

Other Income, Net for the periods presented was as follows:

Current report

The increase in Other Income, Net for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily due to proceeds from insurance related to damaged goods. The change in Other Income, Net for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 was relatively flat.
Removed paragraphs (5)

Previous report

•ROCTAVIAN: higher sales volume from new patients in the U.S. and Europe.

Previous report

Cost of Sales increased in the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024, primarily from higher sales volume.

Previous report

Other Income (Expense), Net

Previous report

Other Income (Expense), Net for the periods presented was as follows:

Previous report

The increase in Other Income (Expense), Net for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was primarily due to higher foreign currency transaction gains and decrease in impairment loss on non-marketable equity securities.
Reworded paragraphs (20)

Previous wording

The increase in Net Product Revenues for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was primarily attributed to the following:

Current wording

The increase in Net Product Revenues for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 was primarily attributed to the following:

Previous wording

•ALDURAZYME: higher sales volume due to timing of order fulfillment to Sanofi; and

Current wording

•ALDURAZYME: lower sales volume due to timing of order fulfillment to Sanofi; and

Previous wording

•PALYNZIQ: higher sales volume from new patients initiating therapy, primarily in the U.S.;

Current wording

•PALYNZIQ: higher sales volume from new patients initiating therapy, primarily in the U.S.; and

Previous wording

We face exposure to movements in foreign currency exchange rates, which we expect to continue in future periods. We use foreign currency exchange forward contracts to hedge a percentage of our foreign currency exposure, primarily the Euro. Certain currencies are not included in our hedging program, such as the Argentine Peso. With respect to the risks posed by fluctuations of both hedged and unhedged currencies against the U.S. dollar, see the risk factor “Our international operations pose currency risks, which may adversely affect our operating results and net income” in “Risk Factors” included in Part II, Item 1Aof this Quarterly Report for additional information. The following table shows our Net Product Revenues denominated in USD and foreign currencies:

Current wording

We face exposure to movements in foreign currency exchange rates, which we expect to continue in future periods. We use foreign currency exchange forward contracts to hedge a percentage of our foreign currency exposure, primarily the Euro. Certain currencies are not included in our hedging program, such as the Argentine Peso. With respect to the risks posed by fluctuations of both hedged and unhedged currencies against the U.S. dollar, see the risk factor “Our international operations pose currency risks, which may adversely affect our operating results and net income” in “Risk Factors” included in Part II, Item 1Aof this

Previous wording

The unfavorable impact for the three and six months ended June 30, 2025 was primarily driven by weakening of the Argentine Peso, Brazilian Real and Mexican Peso. The unfavorable impact for the three and six months ended June 30, 2024 was primarily driven by weakening of Argentine Peso and Japanese Yen, partially offset by strengthening of the Euro.

Current wording

The unfavorable impact for the three and nine months ended September 30, 2025 was primarily driven by weakening of the Argentine Peso, Brazilian Real and Mexican Peso, partially offset by strengthening of the Euro. The unfavorable impact for the three and nine months ended September 30, 2024 was primarily driven by weakening of Argentine Peso, Japanese Yen and Brazilian Real, partially offset by strengthening of the Euro.

Previous wording

The decrease in R&D expense for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was primarily due to lower spend on ROCTAVIAN and the Research and early pipeline programs that were discontinued in 2024. The decrease was partially offset by increased spend on Later-stage clinical programs due to continued progression of VOXZOGO indication for hypochondroplasia.

Current wording

The increase in R&D expense for the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024 was primarily due to acquired In-Process Research and Development (IPR&D) related to a phase 3 clinical program from Inozyme acquisition and increased spend related to the continued progression of VOXZOGO indication for hypochondroplasia. These increases were partially offset by lower spend on Research and early pipeline due to discontinued programs and lower spend on ROCTAVIAN.

Previous wording

The decrease in S&M expense for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was primarily due to reduced activities related to ROCTAVIAN as we focused commercial efforts in the U.S., Germany and Italy to align with our updated ROCTAVIAN strategy announced during the second half of 2024. The decrease in S&M expense for the six months ended June 30, 2025 as compared to the six months ended June 30, 2025 was also attributable to lower spend on Enzyme Therapies following the organizational redesign announced in 2024. These increases were partially offset by increased spending related to global expansion of VOXZOGO for achondroplasia and pre-launch activities of VOXZOGO for hypochondroplasia.

Current wording

The increase in S&M expense for the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024 was primarily due to increased spending related to global expansion of VOXZOGO for achondroplasia and pre-launch activities of VOXZOGO for hypochondroplasia, partially offset by reduced activities related to ROCTAVIAN as we focused commercial efforts in the U.S., Germany and Italy to align with our updated ROCTAVIAN strategy announced during the second half of 2024.

Previous wording

The decrease in G&A expense for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was primarily due to severance and restructuring costs incurred in 2024 associated with our portfolio strategy review and the associated organizational redesign efforts announced in 2024. The decrease was partially offset by incremental administrative costs related to ongoing support of business initiatives.

Current wording

The decrease in G&A expense for the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024 was primarily due to severance and restructuring costs incurred in 2024 associated with our portfolio strategy review and the associated organizational redesign efforts that did not occur in 2025. The decrease in G&A expense was partially offset by post-acquisition severance charges related to Inozyme in 2025 and incremental administrative costs related to ongoing support of business initiatives during the year.

Previous wording

The decrease in Amortization of Intangible Assets for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was due to the increase in the estimated useful life of an intangible asset as a result of the extension of a patent during the second half of 2024 and an intangible asset becoming fully amortized during the fourth quarter of 2024.

Current wording

The decrease in Amortization of Intangible Assets for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was due to the increase in the estimated useful life of an intangible asset as a result of the extension of a patent during the second half of 2024 and an intangible asset becoming fully amortized during the fourth quarter of 2024.

Previous wording

The change in Interest Income for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was relatively flat.

Current wording

The change in Interest Income for the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024 was relatively flat.

Previous wording

The change in Interest Expense for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was relatively flat. See Note 6 to our accompanying Condensed Consolidated Financial Statements for additional information regarding our debt.

Current wording

The change in Interest Expense for the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024 was relatively flat. See Note 6 to our accompanying Condensed Consolidated Financial Statements for additional information regarding our debt.

Previous wording

The increase in Provision for Income Taxes for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 was primarily due to higher pre-tax income and tax expense related to expiration of unexercised options in 2025.

Current wording

The decrease in Provision for Income Taxes for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 was primarily due to lower pre-tax income, partially offset by unfavorable tax impact of a non-deductible acquired IPR&D charge in 2025. The increase in Provision for Income Taxes for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily due to higher pre-tax income and tax expense related to expiration of unexercised options in 2025.

Previous wording

On July 4, 2025, the One Big Beautiful Bill (OBBB) Act, which includes a broad range of tax reform provisions, was signed into law in the United States. The Company is currently assessing the impact of the OBBB Act on the Company’s Consolidated Financial Statements.

Current wording

On July 4, 2025, the One Big Beautiful Bill (OBBB) Act, which includes a broad range of tax reform provisions, was signed into law in the United States. We have estimated the tax effects of the OBBB Act enacted during the quarter and included the related income tax benefit impact in our provision for income taxes. We will continue to evaluate the full impact of these legislative changes as additional guidance becomes available.

Previous wording

We are mindful that conditions in the current macroeconomic environment, such as inflation, changes in interest and foreign currency exchange rates, natural disasters, geopolitical instability, impact of new or increased tariffs and escalating trade tensions, and supply chain disruptions could affect our ability to achieve our goals. In addition, we sell our products in certain countries that face economic volatility and weakness. Although we have historically collected receivables from customers in such countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for our products. We will continue to monitor these conditions and will attempt to adjust our business processes, as appropriate, to mitigate macroeconomic risks to our business.

Current wording

We are mindful that conditions in the current macroeconomic environment, such as inflation, changes in interest and foreign currency exchange rates, natural disasters, geopolitical instability, impact of new or increased tariffs and escalating trade tensions, regulatory uncertainty, and supply chain disruptions could affect our ability to achieve our goals. In addition, we sell our products in certain countries that face economic volatility and weakness. Although we have historically collected receivables from customers in such countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for our products. We will continue to monitor these conditions and will attempt to adjust our business processes, as appropriate, to mitigate macroeconomic risks to our business.

Previous wording

The increase in net cash provided by operating activities in the six months ended June 30, 2025 compared to June 30, 2024 was primarily attributed to an increase in net income and timing of payments to vendors, partially offset by the timing of cash receipts from our customers.

Current wording

The increase in net cash provided by operating activities in the nine months ended September 30, 2025 compared to September 30, 2024 was primarily attributed to an increase in net income adjusted for non-cash items, and timing of payments to vendors and cash receipts from our customers.

Previous wording

The decrease in net cash provided by investing activities in the six months ended June 30, 2025 compared to June 30, 2024 was primarily attributable to lower net maturities of available-for-sale securities and absence of proceeds received in 2024 related to a sale of nonfinancial asset. The decrease was partially offset by fewer purchases of fixed assets and intangible assets.

Current wording

The decrease in net cash provided by investing activities in the nine months ended September 30, 2025 compared to September 30, 2024 was primarily attributable to approximately $285 million net cash paid for acquisition of Inozyme and lower net maturities of available-for-sale securities. The decrease was partially offset by fewer purchases of fixed assets and intangible assets.

Previous wording

The increase in net cash used in financing activities in the six months ended June 30, 2025 compared to June 30, 2024 was primarily due to decreased proceeds from exercises of equity awards offset by lower tax payments related to net share settlement of equity awards.

Current wording

The decrease in net cash used in financing activities in the nine months ended September 30, 2025 compared to September 30, 2024 was primarily due to $495 million settlement of the 2024 Notes that matured in August 2024. The decrease was also attributable to lower proceeds from exercises of equity awards in 2025.

Previous wording

As of June 30, 2025, we had obligations of approximately $585.7 million, of which $236.5 million is expected to be paid in 2025. Our purchase obligations are primarily related to firm purchase commitments entered into in the normal course of business to procure active pharmaceutical ingredients, certain inventory-related items, certain third-party R&D services, production services and facility construction services. The amount also includes hosting fees and other enterprise resource planning (ERP) system implementation costs for which we are committed.

Current wording

As of September 30, 2025, we had obligations of approximately $549.0 million, of which $199.1 million is expected to be paid in 2025. Our purchase obligations are primarily related to firm purchase commitments entered into in the normal course of business to procure active pharmaceutical ingredients, certain inventory-related items, certain third-party R&D services, production services and facility construction services. The amount also includes hosting fees and other enterprise resource planning (ERP) system implementation costs for which we are committed.

Previous wording

As of June 30, 2025, we were subject to contingent payments considered reasonably possible of $229.1 million, of this amount we may pay up to $2.1 million over the next 12 months if certain contingencies are met. See Note 11 to our accompanying Condensed Consolidated Financial Statements for additional discussion on our contingent obligations.

Current wording

As of September 30, 2025, we were subject to contingent payments considered reasonably possible of $231.1 million, and the related contingencies are not expected to be met over the next 12 months. See Note 11 to our accompanying Condensed Consolidated Financial Statements for additional discussion on our contingent obligations.

Previous wording

There have been no significant changes to our critical accounting estimates during the six months ended June 30, 2025, compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 24, 2025.

Current wording

There have been no significant changes to our critical accounting estimates during the nine months ended September 30, 2025, compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 24, 2025.
Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

•NAGLAZYME: lower sales volume due to timing of orders in countries that place large government orders, primarily in Latin America.

Current report — wording carried from elsewhere

The increase in Net Product Revenues for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily attributed to the following:

Current report — wording carried from elsewhere

These increases were partially offset by the following:

Current report — wording carried from elsewhere

Quarterly Report for additional information. The following table shows our Net Product Revenues denominated in USD and foreign currencies: