Segment Information | 15. SEGMENT INFORMATION During the three months ended September 30, 2021 and 2020, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 57 % and 56 %, respectively, of the Company’s consolidated product revenues. During the nine months ended September 30, 2021 and 2020, these two customers within the U.S. segment accounted for 54 % and 47 %, respectively, of the Company’s consolidated product revenues. These same two customers within the U.S. segment accounted for approximately 64 % and 67 % of the Company’s consolidated accounts receivable at September 30, 2021 and at December 31, 2020, respectively. During the first quarter of 2021, the Chief Executive Officer (CEO), who is the chief operating decision maker (CODM), changed the manner in which the CODM monitors performance, aligns strategies and allocates resources, which resulted in a change in the operating segments. The Company’s operations are now managed as three operating segments: U.S., International and Operating Cost. The Company determined that each of these operating segments represented a reportable segment. Previously, the Company was managed as two operating segments: U.S. and International. The Company’s U.S. and International segments represent the sales and marketing, general and administrative and research & development activities dedicated to the respective geographies. The Operating Cost segment primarily represents the general & administrative and research & 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 Company’s CODM 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 and nine months ended September 30, 2021 and 2020: Three Months Ended September 30, 2021 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 6,917 $ 5,236 $ — $ — $ 12,153 LICENSE REVENUE — — — — — NET REVENUE 6,917 5,236 — — 12,153 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 830 ) ( 859 ) — — ( 1,689 ) GROSS PROFIT 6,087 4,377 — — 10,464 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,042 979 1,221 36 3,278 GENERAL AND ADMINISTRATIVE EXPENSES 224 6 2,429 149 2,808 SALES AND MARKETING EXPENSES 3,943 1,610 138 60 5,751 DEPRECIATION AND AMORTIZATION — — — 649 649 OPERATING EXPENSES 5,209 2,595 3,788 894 12,486 SEGMENT INCOME (LOSS) FROM OPERATIONS 878 1,782 ( 3,788 ) ( 894 ) ( 2,022 ) OTHER INCOME AND EXPENSES, NET — — — ( 2,330 ) ( 2,330 ) NET LOSS BEFORE TAXES $ ( 4,352 ) Three Months Ended September 30, 2020 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 6,962 $ 5,511 $ — $ — $ 12,473 LICENSE REVENUE — — — — — NET REVENUE 6,962 5,511 — — 12,473 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 746 ) ( 791 ) — — ( 1,537 ) GROSS PROFIT 6,216 4,720 — — 10,936 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 864 805 752 48 2,469 GENERAL AND ADMINISTRATIVE EXPENSES 168 97 1,964 192 2,421 SALES AND MARKETING EXPENSES 3,328 1,425 132 77 4,962 DEPRECIATION AND AMORTIZATION — — — 677 677 OPERATING EXPENSES 4,360 2,327 2,848 994 10,529 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,856 2,393 ( 2,848 ) ( 994 ) 407 OTHER INCOME AND EXPENSES, NET — — — ( 1,018 ) ( 1,018 ) NET LOSS BEFORE TAXES $ ( 611 ) Nine Months Ended September 30, 2021 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 18,352 $ 15,670 $ — $ — $ 34,022 LICENSE REVENUE — 11,048 — — 11,048 NET REVENUE 18,352 26,718 — — 45,070 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 2,285 ) ( 2,779 ) — — ( 5,064 ) GROSS PROFIT 16,067 23,939 — — 40,006 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,641 3,005 4,343 69 10,058 GENERAL AND ADMINISTRATIVE EXPENSES 694 1,064 7,311 508 9,577 SALES AND MARKETING EXPENSES 10,889 4,407 423 181 15,900 DEPRECIATION AND AMORTIZATION — — — 1,920 1,920 OPERATING EXPENSES 14,224 8,476 12,077 2,678 37,455 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,843 15,463 ( 12,077 ) ( 2,678 ) 2,551 OTHER INCOME AND EXPENSES, NET — — — ( 2,346 ) ( 2,346 ) NET INCOME BEFORE TAXES $ 205 Nine Months Ended September 30, 2020 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 17,449 $ 19,597 $ — $ — 37,046 LICENSE REVENUE — — — — — NET REVENUE 17,449 19,597 — — 37,046 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,928 ) ( 3,021 ) — — ( 4,949 ) GROSS PROFIT 15,521 16,576 — — 32,097 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,720 2,236 2,042 164 7,162 GENERAL AND ADMINISTRATIVE EXPENSES 689 1,139 5,708 658 8,194 SALES AND MARKETING EXPENSES 10,580 4,200 367 252 15,399 DEPRECIATION AND AMORTIZATION — — — 2,016 2,016 OPERATING EXPENSES 13,989 7,575 8,117 3,090 32,771 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,532 9,001 ( 8,117 ) ( 3,090 ) ( 674 ) OTHER INCOME AND EXPENSES, NET — — — ( 3,633 ) ( 3,633 ) NET LOSS BEFORE TAXES $ ( 4,307 ) |