BIOMARIN PHARMACEUTICAL INC
For the period ended Mar 31, 2025. Filed May 2, 2025.
View on SEC.govAbout 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.
Mar 31, 2025 · Filed May 2, 2025
BMRN$56.03-0.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-10-31.
0001048477-24-000152
Item 2. Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-02.
0001048477-25-000051
Item 2. Results of OperationsThe 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 95 previous paragraphs and 72 current paragraphs.
41 unchanged; 19 reworded; 11 added; 28 removed; 7 previous and 1 current paragraphs rearranged.
Tables are not compared: 16 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 (11)
Current report
•ROCTAVIAN: higher sales volume from new patients in the U.S. and Europe; and
Current report
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, primarily in Latin America.
Current report
With respect to KUVAN, see also the risk factor “If we fail to compete successfully with respect to product sales, we may be unable to generate sufficient sales to recover our expenses related to the development of a product program or to justify continued marketing of a product and our revenues could be adversely affected.” in “Risk Factors” included in Part II, Item 1Aof this Quarterly Report for additional information on risks we face.
Current report
With respect to VOXZOGO, see also the risk factor “Our success depends on our ability to manage our growth and execute our corporate strategy.” in "Risk Factors" in Part II, Item 1A of this Quarterly Report for additional information on risk factors that could impact our business and operations.
Current report
The decrease in G&A expense for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to lower employee-related costs and administrative expenses.
Current report
The decrease in Other Income (Expense), Net for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to impairment loss on non-marketable equity securities, partially offset by higher foreign currency transaction gains.
Current report
The increase in net cash used in investing activities in the three months ended March 31, 2025 compared to March 31, 2024 was primarily attributable to higher net purchases of available-for-sale securities, partially offset by the absence of proceeds received in the first quarter of 2024 related to a sale of nonfinancial asset.
Current report
The decrease in net cash used in financing activities in the three months ended March 31, 2025 compared to March 31, 2024 was primarily due to lower taxes paid related to net share settlement of equity awards and absence of proceeds from stock option exercises.
Removed paragraphs (28)
Previous report
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, particularly in the Middle East;
Previous report
•VIMIZIM: higher sales volume due to timing of orders in countries that place large government orders, particularly in Latin America and the Middle East; and
Previous report
The increase in Net Product Revenues for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily attributed to the following:
Previous report
•ALDURAZYME: higher sales volume due to timing of order fulfillment to Sanofi as we recognize ALDURAZYME revenues when the product is released and control is transferred to Sanofi:
Previous report
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, particularly in the Middle East.
Previous report
•VIMIZIM: higher sales volume due to new patients initiating therapy in the U.S. and timing of orders in countries that place large government orders, particularly in Latin America.
Previous report
With respect to KUVAN, see also the risk factor “The sale of generic versions of KUVAN by generic manufacturers has adversely affected and will continue to adversely affect our revenues and may cause a decline in KUVAN revenues faster than expected” in “Risk Factors” included in Part II, Item 1Aof this Quarterly Report for additional information on risks we face.
Previous report
Strong demand for VOXZOGO in certain markets had outpaced our projections in recent quarters and we anticipated challenges meeting our estimated VOXZOGO demand during the first half of 2024. We have recently increased fill-finish capacity to meet this demand and continue to implement actions to manage growth and minimize patient impact. While supply constraints have eased in the second quarter of 2024 and we expect to have the ability to meet estimated demand and support ongoing clinical programs, if actual demand continues to exceed estimates, the supply constraint could be prolonged. We do not expect a material impact on our revenues if we successfully execute our manufacturing plans. See "Risk Factors" in Part II, Item 1A of this Quarterly Report for additional information on risk factors that could impact our business and operations.
Previous report
Royalty and Other Revenues include royalties earned on net sales of products sold by third parties, up-front licensing fees and milestones achieved by licensees or sublicensees.
Previous report
We expect gross margin to increase modestly as our product mix is expected to shift, with increasing sales volumes for our higher margin commercial products.
Previous report
•Marketed products: lower spend on ROCTAVIAN as we shift resources to the new VOXZOGO indications and our prioritized pipeline.
Previous report
•Later-stage clinical programs: higher spend on clinical activities related to VOXZOGO for the treatment of hypochondroplasia.
Previous report
The increase in R&D expense for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to the following:
Previous report
•Research and early pipeline: higher spend related to pre-clinical activities for new VOXZOGO indications and our prioritized pipeline.
Previous report
This increase was partially offset by the following:
Previous report
•Later-stage clinical programs: lower spend on ROCTAVIAN, which was moved to Marketed products following Food and Drug Administration approval in the second quarter of 2023, partially offset by higher spend on the new VOXZOGO indication for hypochondroplasia.
Previous report
We expect R&D expense to increase in future periods, primarily due to increased spending for the new VOXZOGO indications and research and early pipeline programs.
Previous report
The increase in G&A expense for the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023 was primarily due to severance and restructuring costs associated with our portfolio strategy review and the associated organizational redesign efforts announced in 2024. The increase in G&A expense for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 also included incremental administrative costs, including consulting and legal fees.
Previous report
We expect SG&A expense to remain relatively consistent in future periods as continued market expansion of our commercial products is partially offset by the benefits of our ongoing corporate initiatives.
Previous report
The increase in Interest Income for the three and nine months ended September 30, 2024 compared to the three and nine months ended September 30, 2023 was primarily due to higher balances and higher yields on our cash equivalents and investment portfolio. We expect Interest Income to decrease moderately over the next 12 months due to anticipated interest rates and yields on our cash equivalents and investments.
Previous report
The increase in Other Income (Expense), Net for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was primarily due to lower foreign currency transaction losses and the absence of the fiscal 2022 refundable tax credits received in 2023 with no comparable credits in 2024. The increase in Other Income (Expense), Net for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily due to the lower foreign currency transaction losses and decreased loss on non-marketable securities.
Previous report
There was no material impact resulting from the adoption of Pillar Two of the Organisation for Economic Co-operation and Development (OECD) Base Erosion and Profit Shifting Project on our financial statements.
Previous report
The increase in net cash provided by investing activities in the nine months ended September 30, 2024 compared to September 30, 2023 was primarily attributable to lower net purchases of investments and a $10.0 million milestone received in connection with the sale of previously sold intangible assets, partially offset by an increase in purchases of intangible assets.
Previous report
The increase in net cash used in financing activities in the nine months ended September 30, 2024 compared to September 30, 2023 was primarily due to the $495.0 million settlement of the 2024 Notes, which matured in August 2024.
Reworded paragraphs (19)
Previous wording
•PALYNZIQ: higher sales volume from new patients initiating therapy, primarily in the U.S.; and
Current wording
•PALYNZIQ: higher sales volume from new patients initiating therapy, primarily in the U.S.;
Previous wording
•ALDURAZYME: higher sales volume due to timing of order fulfillment to Sanofi as we recognize ALDURAZYME revenues when the product is released and control is transferred to Sanofi;
Current wording
•ALDURAZYME: higher sales volume due to timing of order fulfillment to Sanofi;
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
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 Quarterly Report for additional information. The following table shows our Net Product Revenues denominated in USD and foreign currencies:
Previous wording
The unfavorable impact for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 was relatively flat. The unfavorable impact for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was driven by the weakening of the Argentine Peso, Japanese Yen and Brazilian Real, partially offset by strengthening of the Euro.
Current wording
The unfavorable impact for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily driven by weakening of the Brazilian Real, Euro, Colombian Peso, and Argentine Peso.
Previous wording
Cost of Sales includes raw materials, personnel and facility and other costs associated with manufacturing our commercial products. These costs include production materials, production costs at our manufacturing facilities, third-party manufacturing costs, amortization of technology transfer intangible assets and internal and external final formulation and packaging costs. Cost of Sales also includes royalties payable to third parties based on sales of our products, idle plant costs and charges for inventory valuation reserves.
Current wording
Cost of Sales includes raw materials, personnel and facility and other costs associated with manufacturing our commercial products. These costs include production materials, production costs at our manufacturing facilities, third-party manufacturing costs, amortization of technology transfer intangible assets and internal and external final formulation and packaging costs. Cost of
Previous wording
Cost of Sales increased in the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023, primarily from higher sales volumes and increased ROCTAVIAN inventory reserves, partially offset by lower per-unit manufacturing costs. Gross margin decreased in the current three-month period due to higher sales volumes for products with lower margin, driven by ALDURAZYME sales volume and ROCTAVIAN inventory reserves. Gross margin increased in the current nine-month period due to higher sales volumes for products with higher margin, driven by VOXZOGO sales volume.
Current wording
Cost of Sales increased in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily from higher sales volume and excess and obsolete inventory reserves recorded in the period. Gross margin decreased marginally during the three months ended March 31, 2025 as compared to three months ended March 31, 2024, primarily due to excess and obsolete inventory reserves recorded in the period and higher sales volume for products with lower margin.
Previous wording
The decrease in R&D expense for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 was primarily due to the following:
Current wording
The decrease in R&D expense for the three months ended March 31, 2025 as compared to the three months ended March 31, 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 new VOXZOGO indication for hypochondroplasia which is now a Later-stage clinical program.
Previous wording
The decrease in S&M expense for the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023 was primarily attributed 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.
Current wording
The decrease in S&M expense for the three months ended March 31, 2025 as compared to the three months ended March 31, 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 second half of 2024. The decrease was also attributable to lower spend on Enzyme Therapies following the organizational redesign announced in 2024 and lower distributor fees in 2025. These increases were partially offset by increased spending related to global expansion of VOXZOGO for achondroplasia.
Previous wording
Amortization of intangible assets – the decrease in expense for the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023 was due to the increase in the estimated useful life of an intangible asset and an intangible asset becoming fully amortized during the fourth quarter of 2023.
Current wording
The decrease in Amortization of intangible assets for the three months ended March 31, 2025 as compared to the three months ended March 31, 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 Royalty and Other Revenues for the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023 was relatively flat. We expect to continue to earn royalties from third parties in the future.
Current wording
The change in Interest Income for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was relatively flat.
Previous wording
The decrease in Interest Expense for the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023 was attributed to the maturity of our convertible debt that matured on August 1, 2024 (the 2024 Notes). We expect Interest Expense to decrease over the next 12 months due to the settlement of our 2024 Notes. 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 months ended March 31, 2025 as compared to the three months ended March 31, 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 nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023 was primarily due to higher year-to-date pre-tax income, a lower tax benefit related to stock option exercises, and a discrete benefit for a valuation allowance release in the third quarter of 2023.
Current wording
The increase in Provision for income taxes for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to higher year-to-date taxable income and tax expense related to expiration of unexercised options in the first quarter of 2025.
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, 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, 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 nine months ended September 30, 2024 compared to September 30, 2023 was primarily attributed to the improved operating performance and timing of cash receipts from our customers, partially offset by the timing of payments to vendors, increased personnel-related payments resulting from our ongoing organizational redesign efforts and payment of income taxes.
Current wording
The increase in net cash provided by operating activities in the three months ended March 31, 2025 compared to March 31, 2024 was primarily attributed to increase in net income and timing of payments to vendors, partially offset by the timing of cash receipts from our customers.
Previous wording
Our $600.0 million (undiscounted) of convertible debt as of September 30, 2024 will impact our liquidity due to the semi-annual cash interest payments as well as the repayment of the principal amount, if not converted. As of September 30, 2024, our indebtedness consisted of our 1.25% senior subordinated convertible notes due in 2027, which, if not converted, will be required to be repaid in cash at maturity in May 2027.
Current wording
Our $600.0 million (undiscounted) of convertible debt as of March 31, 2025 will impact our liquidity due to the semi-annual cash interest payments as well as the repayment of the principal amount, if not converted. As of March 31, 2025, our indebtedness consisted of our 1.25% senior subordinated convertible notes due in 2027, which, if not converted, will be required to be repaid in cash at maturity in May 2027. For additional information related to our convertible debt, see Note 6 to our accompanying Condensed Consolidated Financial Statements and Note 10 -Debt to the Consolidated Financial Statements accompanying our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
As of September 30, 2024, we had obligations of approximately $474.1 million, of which $269.8 million is expected to be paid in 2024. 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 March 31, 2025, we had obligations of approximately $586.6 million, of which $299.8 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 September 30, 2024, we were subject to contingent payments considered reasonably possible of $196.1 million, of this amount we may pay up to $4.1 million over the next 12 months if certain contingencies are met. See Note 12 to our accompanying Condensed Consolidated Financial Statements for additional discussion on our contingent obligations.
Current wording
As of March 31, 2025, we were subject to contingent payments considered reasonably possible of $234.1 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.
Previous wording
Our lease and unrecognized tax benefits as of September 30, 2024 have not materially changed from those discussed in “Financial Condition, Liquidity and Capital Resources” in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
Our lease commitments and unrecognized tax benefits as of March 31, 2025 have not materially changed from those discussed in “Financial Condition, Liquidity and Capital Resources” in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
There have been no significant changes to our critical accounting estimates during the nine months ended September 30, 2024, 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, 2023, filed with the SEC on February 26, 2024.
Current wording
There have been no significant changes to our critical accounting estimates during the three months ended March 31, 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 (1)
Current report — wording carried from elsewhere
Sales also includes royalties payable to third parties based on sales of our products, idle plant costs and charges for inventory valuation reserves.
Rearranged previous paragraphs (7)
Previous report — wording carried elsewhere
•PALYNZIQ: higher sales volume due to new patients initiating therapy, primarily in the U.S.
Previous report — wording carried elsewhere
•VOXZOGO: higher sales volume from new patients initiating therapy across all regions;
Previous report — wording carried elsewhere
These increases were partially offset by the following:
Previous report — wording carried elsewhere
•KUVAN: lower product revenues attributed to increasing generic competition as a result of the loss of market exclusivity.
Previous report — wording carried elsewhere
Quarterly Report for additional information. The following table shows our Net Product Revenues denominated in USD and foreign currencies:
Previous report — wording carried elsewhere
The decrease was partially offset by the following:
Previous report — wording carried elsewhere
For additional information related to our convertible debt, see Note 6 to our accompanying Condensed Consolidated Financial Statements and Note 10 -Debt to the Consolidated Financial Statements accompanying our Annual Report on Form 10-K for the year ended December 31, 2023.