BIOMARIN PHARMACEUTICAL INC
For the period ended Sep 30, 2024. Filed Oct 31, 2024.
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.
Sep 30, 2024 · Filed Oct 31, 2024
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 2024-06-30; filed 2024-08-05.
0001048477-24-000126
Item 2. Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-10-31.
0001048477-24-000152
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 88 previous paragraphs and 95 current paragraphs.
57 unchanged; 26 reworded; 11 added; 4 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 16 previous and 16 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
•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 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
Current report
These increases were partially offset by the following:
Current 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:
Current 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.
Current report
These increases were partially offset by the following:
Current report
The decrease was partially offset by the following:
Current report
This increase was partially offset by the following:
Current report
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 report
In August 2024, we entered into an unsecured revolving credit facility providing for $600.0 million in revolving loan commitments. The credit facility is intended to finance ongoing working capital needs and for other general corporate purposes. The credit facility contains financial covenants including a maximum total net leverage ratio and a minimum interest coverage ratio. The credit facility matures in August 2029. As of September 30, 2024, there were no amounts outstanding under the credit facility and we were in compliance with all covenants.
Removed paragraphs (4)
Previous report
•Research and early pipeline: higher spend related to pre-clinical activities for new VOXZOGO indications for idiopathic short stature (ISS) and multiple genetic short stature pathway conditions (PC) and our prioritized pipeline comprised of BMN 333, BMN 349 and BMN 351; and
Previous report
The increase in S&M expense for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 was primarily attributed to continued global expansion of VOXZOGO for achondroplasia and higher partner distribution fees. The increase in S&M expense for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily a result of the continued global expansion of VOXZOGO for achondroplasia.
Previous report
Our 2024 Notes matured on August 1, 2024, subsequent to quarter-end. Substantially all holders of the 2024 Notes were repaid with cash, totaling approximately $495.0 million in cash. No gain or loss was incurred upon the extinguishment.
Reworded paragraphs (26)
Previous wording
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, particularly in the Middle East and Europe.
Current wording
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, particularly in the Middle East;
Previous wording
The increase in Net Product Revenues for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily attributed to the following:
Current wording
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 wording
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, particularly in the Middle East, Europe and Latin America; and
Current wording
•NAGLAZYME: higher sales volume due to timing of orders in countries that place large government orders, particularly in the Middle East.
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, 2024 as compared to the three and six months ended June 30, 2023 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 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.
Previous wording
The change in Royalty and Other Revenues for the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023 was relatively flat. We expect to continue to earn royalties from third parties in the future.
Current 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.
Previous wording
Cost of Sales decreased in the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023, primarily from lower per-unit manufacturing costs partially offset by higher sales volumes. Gross margin increased in the current three and six 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 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.
Previous wording
The increase in R&D expense for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 was primarily due to the following:
Current 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:
Previous wording
•Marketed products: lower spend on ROCTAVIAN and VOXZOGO for achondroplasia as we shift resources to the new VOXZOGO indications and our prioritized pipeline.
Current wording
•Marketed products: lower spend on ROCTAVIAN as we shift resources to the new VOXZOGO indications and our prioritized pipeline.
Previous wording
The increase in R&D expense for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily due to the following:
Current wording
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 wording
•Research and early pipeline: higher spend related to pre-clinical activities for new VOXZOGO indications for ISS and PC and our prioritized pipeline; and
Current wording
•Research and early pipeline: higher spend related to pre-clinical activities for new VOXZOGO indications and our prioritized pipeline.
Previous wording
The increase in G&A expense for the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023 was primarily due to severance and restructuring costs associated with our portfolio strategy review and the associated organizational redesign efforts announced in the second quarter of 2024. The increase in G&A expense for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 also included incremental administrative costs, including consulting and legal fees.
Current wording
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 wording
We expect SG&A expense to increase in future periods as a result of ongoing corporate initiatives and the continued market expansion of our commercial products.
Current wording
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 wording
Amortization of intangible assets – the decrease in expense for the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023 was due to an intangible asset becoming fully amortized during the fourth quarter of 2023.
Current 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.
Previous wording
The increase in Interest Income for the three and six months ended June 30, 2024 compared to the three and six months ended June 30, 2023 was primarily due to higher balances and higher yields on our cash equivalents and investment portfolio. We expect Interest Income to increase moderately over the next 12 months due to anticipated higher overall returns on our cash equivalents and investments.
Current wording
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 wording
Interest Expense for the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023 was relatively flat. We expect Interest Expense to decrease over the next 12 months due to the settlement of our convertible debt that matured on August 1, 2024. See Note 6 to our accompanying Condensed Consolidated Financial Statements for additional information regarding our debt.
Current 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.
Previous wording
Other Expense, Net for the periods presented was as follows:
Current wording
Other Income (Expense), Net for the periods presented was as follows:
Previous wording
The increase in Other Expense, Net for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 was primarily due to a loss on non-marketable securities partially offset by lower foreign currency transaction losses in the comparable period in 2023. The decrease in Other Expense, Net for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was primarily due to the decrease in loss on non-marketable securities partially offset by lower foreign currency transaction losses.
Current wording
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 wording
The increase in Provision for Income Taxes for the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023 was primarily due to higher pre-tax income and a lower tax benefit related to stock option exercises.
Current 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.
Previous wording
The increase in net cash provided by operating activities in the six months ended June 30, 2024 compared to June 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 and payments of income taxes.
Current 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.
Previous wording
The increase in net cash provided by investing activities in the six months ended June 30, 2024 compared to June 30, 2023 was primarily attributable to lower purchases of available-for-sale debt securities net of maturities 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.
Current wording
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 wording
The increase in net cash used in financing activities in the six months ended June 30, 2024 compared to June 30, 2023 was primarily due to lower proceeds from stock option exercises, partially offset by the absence of milestone payments to third parties.
Current wording
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.
Previous wording
Our $1.1 billion (undiscounted) of total convertible debt as of June 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 June 30, 2024, our indebtedness consisted of our 0.599% senior subordinated convertible notes due in 2024 and 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 August 2024 and May 2027, respectively. As of June 30, 2024, the outstanding principal of our convertible notes due in 2024 (2024 Notes) was classified as a current liability.
Current 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.
Previous wording
As of June 30, 2024, we had obligations of approximately $473.0 million, of which $291.1 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 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.
Previous wording
As of June 30, 2024, we were subject to contingent payments considered reasonably possible of $495.6 million, of this amount we may pay up to $10.9 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 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.
Previous wording
There have been no significant changes to our critical accounting estimates during the six months ended June 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 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.
Rearranged current paragraphs (1)
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:
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
•Marketed products: higher spend primarily related to ROCTAVIAN, which was moved to Marketed products following Food and Drug Administration approval in the second quarter of 2023.