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SEGMENT INFORMATION | 12 Months Ended
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Dec. 31, 2024
Segment Reporting [Abstract] |
SEGMENT INFORMATION | SEGMENT INFORMATION The Company operates and is managed as one operating segment which derives revenue from activities related to the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company’s commercial organization is responsible for marketing our approved products worldwide. The Company’s R&D organization is responsible for research and discovery of new product candidates and supporting the development and registration efforts for potential new products. The Company’s technical operations group is responsible for the development of manufacturing processes, supplying clinical drug product, and the manufacturing and distribution of our commercial products. The Company is also supported by corporate staff functions. The Company’s Chief Executive Officer as the CODM manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals. In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. The key measure of segment profit or loss used by the CODM to allocate resources and assess the Company's performance is its consolidated Net Income, as reported on the Consolidated Statements of Income. The CODM's analysis includes a comparison to budgeted results. Segment assets provided to the CODM are consistent with those reported on the Consolidated Balance Sheets with particular emphasis on the Company's available liquidity including cash, cash equivalents, investments, accounts receivable and inventory. The following table includes information about segment revenue, significant segment expenses, and segment measure of profitability:
|  |  | Twelve Months Ended December 31,
|  |  |  |  | 2024 |  | 2023 |  | 2022
Total revenues |  |  |  |  | $ | 2,853,915 |  |  | $ | 2,419,226 |  |  | $ | 2,096,039 |
Less: |  |  |  |  |  |  |  |  |
Cost of sales |  |  |  |  | 580,235 |  |  | 532,062 |  |  | 503,023 |
R&D expenses |  |  |  |  |  |  |  |  |
Research and early pipeline |  |  |  |  | 434,023 |  |  | 393,078 |  |  | 313,915 |
Later-stage clinical programs |  |  |  |  | 27,581 |  |  | 62,604 |  |  | 119,015 |
Marketed products |  |  |  |  | 285,580 |  |  | 291,091 |  |  | 216,676 |
SG&A expenses |  |  |  |  |  |  |  |  |
S&M expenses |  |  |  |  | 476,739 |  |  | 488,442 |  |  | 450,349 |
G&A expenses |  |  |  |  | 532,286 |  |  | 403,964 |  |  | 372,894 |
Other segment expense (income), net (1) |  |  |  |  | 90,612 |  |  | 80,340 |  |  | (21,394) |
Net income |  |  |  |  | $ | 426,859 |  |  | $ | 167,645 |  |  | $ | 141,561 |
(1)Other segment expense (income), net during the years ended December 31, 2024, 2023 and 2022 include Intangible asset amortization, Interest income and expense, Other expense, net and the Provision for income taxes. The years ended December 31, 2024 and 2022 also include Gain on sale of nonfinancial assets. The following table presents Total Revenues and disaggregates Net Product Revenues by product.
| Years Ended December 31,
| 2024 |  | 2023 |  | 2022
VIMIZIM | $ | 739,784 |  |  | $ | 701,053 |  |  | $ | 663,739 |
VOXZOGO | 735,092 |  |  | 469,881 |  |  | 169,128 |
NAGLAZYME | 479,584 |  |  | 420,292 |  |  | 443,794 |
PALYNZIQ | 355,047 |  |  | 303,919 |  |  | 255,032 |
ALDURAZYME | 183,887 |  |  | 131,248 |  |  | 128,422 |
BRINEURA | 169,083 |  |  | 161,889 |  |  | 154,333 |
KUVAN | 120,902 |  |  | 180,767 |  |  | 227,577 |
ROCTAVIAN | 26,066 |  |  | 3,489 |  |  | — |
Total net product revenues | 2,809,445 |  |  | 2,372,538 |  |  | 2,042,025 |
Royalty and other revenues | 44,470 |  |  | 46,688 |  |  | 54,014 |
Total revenues | $ | 2,853,915 |  |  | $ | 2,419,226 |  |  | $ | 2,096,039 |
The Company considers there to be revenue concentration risks for regions where Net Product Revenues exceed 10% of consolidated Net Product Revenues. The concentration of the Company’s Net Product Revenues within the regions below may have a material adverse effect on the Company’s revenues and results of operations if sales in the respective regions experience difficulties. The table below disaggregates total Net Product Revenues by geographic region, which is based on patient location for Company's commercial products sold directly by the Company, except for ALDURAZYME, which is distributed, marketed and sold exclusively by Sanofi worldwide.
| Years Ended December 31,
| 2024 |  | 2023 |  | 2022
United States | $ | 924,810 |  |  | $ | 771,314 |  |  | $ | 684,284 |
Europe | 829,031 |  |  | 669,331 |  |  | 650,952 |
Latin America | 378,084 |  |  | 332,437 |  |  | 266,801 |
Rest of world | 493,633 |  |  | 468,208 |  |  | 311,566 |
Total net product revenues marketed by the Company | 2,625,558 |  |  | 2,241,290 |  |  | 1,913,603 |
ALDURAZYME net product revenues marketed by Sanofi | 183,887 |  |  | 131,248 |  |  | 128,422 |
Total net product revenues | $ | 2,809,445 |  |  | $ | 2,372,538 |  |  | $ | 2,042,025 |
The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the periods presented.
| Years Ended December 31,
| 2024 |  | 2023 |  | 2022
Customer A | 13 | % |  | 14 | % |  | 16 | %
Customer B | 12 | % |  | 12 | % |  | 12 | %
Total | 25 | % |  | 26 | % |  | 28 | %
Long-lived assets, which consist of net property, plant and equipment and ROU assets are summarized by geographic region in the following table.
| December 31,
| 2024 |  | 2023
Long-lived assets by geography: |  |  |
United States | $ | 755,069 |  |  | $ | 788,590 |
Ireland | 308,123 |  |  | 306,542 |
Rest of world | 13,600 |  |  | 17,075 |
Total long-lived assets | $ | 1,076,792 |  |  | $ | 1,112,207 |
Concentration Information On a consolidated basis, two customers accounted for 20% and 11% of the Company’s December 31, 2024 accounts receivable balance, respectively, compared to December 31, 2023 when two customers accounted for 15% and 12% of the accounts receivable balance, respectively. As of December 31, 2024 and 2023, the accounts receivable balance for Sanofi included $96.8 million and $63.4 million, respectively, of unbilled accounts receivable, which becomes payable to the Company when the product is sold through by Sanofi. The Company does not require collateral from its customers, but does perform periodic credit evaluations of its customers’ financial condition and requires prepayments in certain circumstances. The Company is mindful that conditions in the current macroeconomic environment, such as inflation, changes in interest and foreign currency exchange rates, natural disasters and supply chain disruptions, could affect the Company’s ability to achieve its goals. In addition, the Company sells its products in countries that face economic volatility and weakness. Although the Company has historically collected receivables from customers in certain countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to delay payment or be unable to pay for the Company’s products. The Company believes that the allowances for doubtful accounts related to these countries, if any, are adequate based on its analysis of the specific business circumstances and expectations of collection for each of the underlying accounts in these countries. The Company will continue to monitor these conditions and will attempt to adjust its business processes, as appropriate, to mitigate macroeconomic risks to its business.

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- Definition The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments. + References Reference 1: http://www.xbrl.org/2003/role/exampleRef -Topic 280 -SubTopic 10 -Name Accounting Standards Codification -Section 55 -Paragraph 48 -Publisher FASB -URI https://asc.fasb.org/1943274/2147482785/280-10-55-48 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Topic 280 -SubTopic 10 -Name Accounting Standards 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