Revenue | Revenue Contract Balances Timing of revenue recognition may differ from timing of invoicing to customers. The Company records an asset when revenue is recognized prior to invoicing a customer (a “contract asset”). Contract assets are included within Prepaid expenses and other current assets in the Company’s Consolidated Balance Sheets and are transferred to accounts receivable when the right to payment becomes unconditional. The balance of contract assets recorded in the Company’s Consolidated Balance Sheets as of September 29, 2024 and December 31, 2023 was $39.5 million and $46.2 million, respectively. The contract asset balance consisted of the following components: • a customer supply agreement under which the difference between the timing of invoicing and revenue recognition resulted in a contract asset of $1.9 million as of December 31, 2023. There was no contract asset remaining as of September 29, 2024; • contractual arrangements with certain customers under which the Company invoices the customers based on reportable results generated by its reagents; however, control of the goods transfers to the customers upon shipment or delivery of the products, as determined under the terms of the contract. Using the expected value method, the Company estimates the number of reagents that will generate a reportable result. The Company records the revenue upon shipment and an associated contract asset, and relieves the contract asset upon completion of the invoicing. The balance of the contract asset related to these arrangements was $39.5 million and $41.8 million as of September 29, 2024 and December 31, 2023, respectively; and • one of the Company’s contract manufacturing agreements that recognizes revenue as the products are manufactured resulted in a contract asset of $2.5 million as of December 31, 2023. There was no contract asset remaining as of September 29, 2024. The Company reviews contract assets for expected credit losses resulting from the collectability of customer accounts. Expected losses are established based on historical losses, customer mix and credit policies, current economic conditions in customers’ country or industry, and expectations associated with reasonable and supportable forecasts. No credit losses related to contract assets were recognized during the three and nine months ended September 29, 2024 and October 1, 2023. The Company recognizes a contract liability when a customer pays an invoice prior to the Company transferring control of the goods or services (“contract liabilities”). The Company’s contract liabilities consist of deferred revenue primarily related to customer service contracts. The Company classifies deferred revenue as current or non-current based on the timing of the transfer of control or performance of the service. The balance of the Company’s current deferred revenue was $41.9 million and $36.8 million as of September 29, 2024 and December 31, 2023, respectively, and was included in Other current liabilities in the Consolidated Balance Sheets. The Company has one arrangement with a customer where the revenue is expected to be recognized beyond one year. The balance of the deferred revenue included in long-term liabilities was $17.4 million and $13.9 million as of September 29, 2024 and December 31, 2023, respectively, and was included in Other liabilities in the Consolidated Balance Sheets. The amount of deferred revenue as of December 31, 2023 that was recorded in Total revenues during the three and nine months ended September 29, 2024 was $4.8 million and $31.8 million, respectively. Joint Business with Grifols The Company has an ongoing Joint Business between Ortho and Grifols, under which Ortho and Grifols agreed to pursue a collaboration relating to Ortho’s Hepatitis and HIV diagnostics business. The governance of the Joint Business is shared through a supervisory board made up of equal representation by Ortho and Grifols, which is responsible for all significant decisions relating to the Joint Business that are not exclusively assigned to either Ortho or Grifols, as defined in the Joint Business agreement. The Company’s portion of the pre-tax net profit shared under the Joint Business was $7.3 million and $24.3 million during the three and nine months ended September 29, 2024, respectively, and $8.9 million and $38.6 million during the three and nine months ended October 1, 2023, respectively. These amounts included the Company’s portion of the pre-tax net profit of $5.3 million and $16.8 million during the three and nine months ended September 29, 2024, respectively, and $7.3 million and $14.0 million during the three and nine months ended October 1, 2023, respectively, on sales transactions with third parties where the Company is the principal. The Company recognized revenues, cost of sales, excluding amortization of intangibles, and operating expenses, on a gross basis on these sales transactions in their respective lines in the Consolidated Statements of Loss. The Company’s portion of the pre-tax net profit also included revenue from collaboration and royalty agreements of $2.0 million and $7.5 million during the three and nine months ended September 29, 2024, respectively, and $1.6 million and $24.6 million during the three and nine months ended October 1, 2023, respectively, which is presented on a net basis within Total revenues. Disaggregation of Revenue The following table summarizes Total revenues by business unit: Three Months Ended Nine Months Ended (In millions) September 29, 2024 October 1, September 29, 2024 October 1, Labs $ 355.9 $ 341.4 $ 1,067.0 $ 1,073.5 Immunohematology (1) 132.0 128.9 385.9 380.1 Donor Screening (1) 28.0 35.0 95.7 103.0 Point of Care 205.6 233.1 509.3 675.4 Molecular Diagnostics 5.6 5.6 17.2 23.2 Total revenues $ 727.1 $ 744.0 $ 2,075.1 $ 2,255.2 (1) For presentation purposes, as a result of the wind-down of the U.S. donor screening portfolio, the previously reported Transfusion Medicine business unit is shown in its two product categories: Immunohematology and Donor Screening. Prior periods have been revised to align with the current period presentation. Concentration of Revenue and Credit Risk For the nine months ended September 29, 2024, one customer represented 11% of Total revenues. For the nine months ended October 1, 2023, no customers individually accounted for more than 10% of Total revenues. Revenue related to the Company’s respiratory products accounted for 23% and 17% of Total revenues for the three and nine months ended September 29, 2024, respectively, and 25% and 24% for the three and nine months ended October 1, 2023, respectively. As of September 29, 2024 and December 31, 2023, customers with a balance due in excess of 10% of Accounts receivable, net totaled $63.0 million and $63.5 million, respectively. |