REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATIONThe 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 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 following table disaggregates Total Revenues from external customers and collaborative partners by geographic region. Net product revenues by geographic region are based on patient location for the Company’s commercial products, except for Aldurazyme, which is sold exclusively to Sanofi Genzyme (Genzyme) who markets and sells Aldurazyme world-wide. Aldurazyme revenues earned by the Company are included in the U.S. region as the transactions are with Genzyme, whose headquarters is located in the U.S. Three Months Ended Nine Months Ended 2020 2019 2020 2019 Total revenues by geographic region: United States $ 252,948 $ 201,874 $ 729,672 $ 562,217 Europe 121,158 125,485 375,453 369,585 Latin America 44,064 83,799 141,852 164,132 Rest of world 58,614 49,939 161,361 153,671 Total revenues $ 476,784 $ 461,097 $ 1,408,338 $ 1,249,605 The following table disaggregates Net Product Revenues by product. Three Months Ended Nine Months Ended 2020 2019 2020 2019 Net product revenues by product: Vimizim $ 147,891 $ 163,466 $ 401,789 $ 411,953 Kuvan 123,993 120,524 368,604 340,771 Naglazyme 76,323 94,408 271,585 279,462 Palynziq 46,092 24,142 121,354 55,250 Brineura 25,455 19,840 75,223 46,815 Firdapse — 5,668 1,316 16,262 Total net product revenues marketed by the Company $ 419,754 $ 428,048 $ 1,239,871 $ 1,150,513 Aldurazyme net product revenues marketed by Genzyme 40,987 22,852 $ 128,945 $ 73,945 Total net product revenues $ 460,741 $ 450,900 $ 1,368,816 $ 1,224,458 The table below disaggregates total Net Product Revenues based on patient location for products sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Three Months Ended Nine Months Ended 2020 2019 2020 2019 United States $ 203,892 $ 175,127 $ 582,734 $ 480,330 Europe 115,548 121,363 360,718 358,041 Latin America 44,064 83,799 141,852 164,132 Rest of world 56,250 47,759 154,567 148,010 Total net product revenues marketed by the Company 419,754 428,048 1,239,871 1,150,513 Aldurazyme net product revenues marketed by Genzyme 40,987 22,852 128,945 73,945 Total net product revenues $ 460,741 $ 450,900 $ 1,368,816 $ 1,224,458 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 2020 2019 2020 2019 Customer A 16 % 16 % 15 % 17 % Customer B 14 % 13 % 14 % 12 % Customer C 11 % 10 % 12 % 11 % Customer D 1 % 12 % 3 % 6 % Total 42 % 51 % 44 % 46 % On a consolidated basis, two customers accounted for 33% and 15% of the September 30, 2020 accounts receivable balance, respectively, compared to December 31, 2019, when two customers accounted for 24% and 16% of the accounts receivable balance, respectively. As of September 30, 2020, and December 31, 2019, the accounts receivable balance for Genzyme included $106.5 million and $60.2 million, respectively, of unbilled accounts receivable, which becomes payable to the Company when the product is sold by Genzyme. 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 outbreak of COVID-19 continues to affect economies and business around the world. The Company experienced a modest impact on its global revenue sources, mostly in the form of demand interruptions such as missed patient infusions and delayed treatment starts for new patients, in the three and nine months ended September 30, 2020 and the Company anticipates a continued impact on its financial results for the remainder of 2020 and into fiscal year 2021. The extent and duration of such effects are highly uncertain and difficult to predict. 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. See the risk factor related to the impact of the coronavirus pandemic, “The coronavirus, or COVID-19, pandemic could materially adversely affect our business, results of operations and financial condition.” described in “Risk Factors” in Part II, Item 1A of this Quarterly Report, for additional details on the impact of the COVID-19 pandemic. The Company is mindful that conditions in the current macroeconomic environment could affect the Company’s ability to achieve its goals. 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 and effects of the impact of the ongoing COVID-19 pandemic 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. |