REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION The Company operates in one business segment, which primarily focuses on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The following table disaggregates total Net Product Revenues by product. Three Months Ended Nine Months Ended 2022 2021 2022 2021 Net product revenues by product: VIMIZIM $ 155,470 $ 136,744 $ 511,735 $ 466,697 NAGLAZYME 99,506 71,172 343,320 297,321 PALYNZIQ 66,206 60,729 182,734 173,702 KUVAN 57,038 67,687 173,977 217,257 VOXZOGO 48,289 144 102,321 144 BRINEURA 37,793 32,984 111,691 90,641 Total net product revenues marketed by the Company 464,302 369,460 1,425,778 1,245,762 ALDURAZYME net product revenues marketed by Sanofi 29,046 24,380 90,755 102,517 Total net product revenues 493,348 393,840 1,516,533 1,348,279 Royalty and other revenues 11,996 14,902 41,968 48,186 Total revenues $ 505,344 $ 408,742 $ 1,558,501 $ 1,396,465 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 sold exclusively by Sanofi worldwide. Three Months Ended Nine Months Ended 2022 2021 2022 2021 United States $ 176,552 $ 166,554 $ 497,205 $ 491,028 Europe 162,583 108,568 480,645 424,144 Latin America 60,791 38,958 213,246 140,911 Rest of world 64,376 55,380 234,682 189,679 Total net product revenues marketed by the Company $ 464,302 $ 369,460 $ 1,425,778 $ 1,245,762 ALDURAZYME net product revenues marketed by Sanofi 29,046 24,380 90,755 102,517 Total net product revenues $ 493,348 $ 393,840 $ 1,516,533 $ 1,348,279 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. Three Months Ended Nine Months Ended 2022 2021 2022 2021 Customer A 15 % 20 % 16 % 17 % Customer B 14 % 16 % 12 % 14 % Customer C 10 % 11 % 9 % 10 % Total 39 % 47 % 37 % 41 % On a consolidated basis, two customers accounted for 23% and 15% of the Company’s September 30, 2022 accounts receivable balance, respectively, compared to December 31, 2021, when two customers accounted for 28% and 16% of the accounts receivable balance, respectively. As of September 30, 2022, and December 31, 2021, the accounts receivable balance for Sanofi included $65.3 million and $67.9 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's global revenue sources and its business operations were impacted by the COVID-19 pandemic during the nine months ended September 30, 2022 and 2021, mostly in the form of demand interruptions such as missed patient infusions and delayed treatment starts for new patients, and the Company anticipates a continued impact due to COVID-19 on its financial results in 2022. The extent and duration of such effects remain uncertain and difficult to predict, particularly as virus variants continue to spread. The Company is actively monitoring and managing its response and assessing actual and potential impacts to its operating results and financial condition, as well as developments in its business, which could further impact developments, trends and expectations. The Company is mindful that conditions in the current macroeconomic environment, such as inflation, supply chain disruptions and impacts of the ongoing COVID-19 pandemic, could affect the Company’s ability to achieve its goals. In addition, the Company sells its products in certain 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. |