Segment Information | 15. SEGMENT INFORMATION During the three months ended June 30, 2023 and 2022, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 68 % and 61 % of the Company’s consolidated product revenues, respectively. During the six months ended June 30, 2023 and 2022, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 63 % and 60 % of the Company’s consolidated product revenues, respectively. These same two customers within the U.S. segment accounted for approximately 71 % of the Company’s consolidated accounts receivable at June 30, 2023 and at December 31, 2022 The Chief Executive Officer (CEO), who is the Company’s chief operating decision maker, has determined that the Company’s operations are managed as three operating segments: U.S., International and Operating Cost. The Company determined that each of these operating segments represented a reportable segment. In monitoring performance, aligning strategies and allocating resources, the chief operating decision maker manages and evaluates the Company’s U.S., International and Operating Cost segments based on segment income or loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. Therefore, the Company classifies within Other (a) the non-cash expenses included in research, development and medical affairs expenses; general and administrative expenses; and sales and marketing expenses; and (b) depreciation and amortization. The Company’s U.S. and International segments represent the sales and marketing, general and administrative and research and development activities dedicated to the respective geographies. The Operating Cost segment primarily represents the general and administrative and research and development activities not specifically associated with the U.S. or International segments and includes expenses such as executive management; information technology administration and support; legal; compliance; clinical studies; and business development. Each of the Company’s U.S., International and Operating Cost segments is separately managed and is evaluated primarily upon segment income or loss from operations. Other is presented to reconcile to the Company’s consolidated totals. The Company does not report balance sheet information by segment because the chief operating decision maker does not review that information. The Company allocates certain operating expenses among its reporting segments based on activity-based costing methods. These activity-based costing methods require the Company to make estimates that affect the amount of each expense category that is attributed to each segment. Changes in these estimates will directly affect the amount of expense allocated to each segment and therefore the operating profit of each reporting segment. The following tables present a summary of the Company’s reporting segments for the three months ended June 30, 2023 and 2022: Three Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 11,876 $ 5,662 $ — $ — $ 17,538 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,290 ) ( 1,135 ) — — ( 2,425 ) GROSS PROFIT 10,586 4,527 — — 15,113 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,748 842 1,033 25 3,648 GENERAL AND ADMINISTRATIVE EXPENSES 1,101 510 2,619 143 4,373 SALES AND MARKETING EXPENSES 4,781 1,379 225 49 6,434 DEPRECIATION AND AMORTIZATION — — — 1,866 1,866 OPERATING EXPENSES 7,630 2,731 3,877 2,083 16,321 SEGMENT INCOME (LOSS) FROM OPERATIONS 2,956 1,796 ( 3,877 ) ( 2,083 ) ( 1,208 ) OTHER INCOME AND EXPENSES, NET — — — ( 8,796 ) ( 8,796 ) NET LOSS BEFORE TAXES $ ( 10,004 ) Three Months Ended June 30, 2022 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 8,943 $ 5,661 $ — $ — $ 14,604 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,060 ) ( 1,106 ) — — ( 2,166 ) GROSS PROFIT 7,883 4,555 — — 12,438 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,281 807 1,799 45 3,932 GENERAL AND ADMINISTRATIVE EXPENSES 195 468 2,112 170 2,945 SALES AND MARKETING EXPENSES 4,568 2,112 133 52 6,865 DEPRECIATION AND AMORTIZATION — — — 670 670 OPERATING EXPENSES 6,044 3,387 4,044 937 14,412 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,839 1,168 ( 4,044 ) ( 937 ) ( 1,974 ) OTHER INCOME AND EXPENSES, NET — — — ( 1,124 ) ( 1,124 ) NET LOSS BEFORE TAXES $ ( 3,098 ) The following tables present a summary of the Company’s reporting segments for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 19,456 $ 11,628 $ — $ — $ 31,084 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 2,195 ) ( 2,258 ) — — ( 4,453 ) GROSS PROFIT 17,261 9,370 — — 26,631 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,910 1,589 3,266 47 7,812 GENERAL AND ADMINISTRATIVE EXPENSES 2,205 1,227 4,814 298 8,544 SALES AND MARKETING EXPENSES 9,056 2,794 291 97 12,238 DEPRECIATION AND AMORTIZATION — — — 2,547 2,547 OPERATING EXPENSES 14,171 5,610 8,371 2,989 31,141 SEGMENT INCOME (LOSS) FROM OPERATIONS 3,090 3,760 ( 8,371 ) ( 2,989 ) ( 4,510 ) OTHER INCOME AND EXPENSES, NET — — — ( 10,462 ) ( 10,462 ) NET LOSS BEFORE TAXES $ ( 14,972 ) Six Months Ended June 30, 2022 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 15,863 $ 10,639 $ — $ — $ 26,502 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,875 ) ( 1,971 ) — — ( 3,846 ) GROSS PROFIT 13,988 8,668 — — 22,656 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,451 1,723 3,259 82 7,515 GENERAL AND ADMINISTRATIVE EXPENSES 511 892 4,393 389 6,185 SALES AND MARKETING EXPENSES 9,242 4,116 250 110 13,718 DEPRECIATION AND AMORTIZATION — — — 1,359 1,359 OPERATING EXPENSES 12,204 6,731 7,902 1,940 28,777 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,784 1,937 ( 7,902 ) ( 1,940 ) ( 6,121 ) OTHER INCOME AND EXPENSES, NET — — — ( 2,932 ) ( 2,932 ) NET INCOME BEFORE TAXES $ ( 9,053 ) |