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SEGMENT INFORMATION (Tables) | 12 Months Ended
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Dec. 31, 2024
SEGMENT INFORMATION |
Schedule of segment information | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Years ended | ​
​ | ​ | December 31, | ​
​ | ​ | 2024 | ​ | 2023 | ​
​ |  | ​ | ​ | As Restated* | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Product revenue | ​ | $ | 35,594,520 | ​ | $ | 31,084,953 | ​
Gross Profit | ​ | $ | 25,125,991 | ​ | $ | 21,953,237 | ​
Gross Margin | ​ | ​ | 71 | % |  | 71 | %
Total Operating Expenses | ​ | $ | 41,911,930 | ​ | $ | 53,901,857 | ​
EBITDA and Adjusted EBITDA (both non-GAAP measures): | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss | ​ | $ | (20,718,957) | ​ | $ | (29,246,760) | ​
Interest expense | ​ |  | 1,399,092 | ​ |  | (157,891) | ​
Benefits from income taxes | ​ | ​ | (1,690,825) | ​ | ​ | 813,739 | ​
Depreciation and amortization expense | ​ | ​ | 1,570,104 | ​ | ​ | 1,459,066 | ​
Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure | ​ | ​ | (19,440,586) | ​ | ​ | (28,443,541) | ​
Stock-based compensation | ​ | ​ | 3,759,534 | ​ | ​ | 4,155,342 | ​
Gain (loss) on foreign currency transactions | ​ | ​ | 4,224,721 | ​ | ​ | (1,949,257) | ​
Adjusted EBITDA, a non-GAAP measure | ​ | $ | (11,456,331) | ​ | $ | (26,237,456) | ​
Adjusted net loss, a non-GAAP measure: | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss | ​ | $ | (20,718,957) | ​ | $ | (29,246,760) | ​
Stock-based compensation | ​ | ​ | 3,759,534 | ​ | ​ | 4,155,342 | ​
Gain (loss) on foreign currency transactions | ​ | ​ | 4,224,721 | ​ | ​ | (1,949,257) | ​
Adjusted net loss, a non-GAAP measure | ​ | $ | 12,734,702 | ​ | $ | 27,040,675 | ​
Total cash used in operating and investing activities | ​ | $ | (15,097,239) | ​ | $ | (22,591,372) | ​
Total Assets | ​ | $ | 47,675,811 | ​ | $ | 52,956,322 | ​
* See Note 12 – Restatement of Previously Issued financial information for details. ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Years ended December 31,
​ | ​ | 2024 |  | 2023
​ |  | ​ | ​ | As Restated*
​ | ​ | ​ | ​ | ​ | ​ | ​
Research and development: | ​ | ​ | ​ | ​ | ​ | ​
Clinical expenses | ​ | $ | 4,482,691 | ​ | $ | 11,329,684
Other research and development expenses | ​ |  | 2,433,490 | ​ |  | 4,264,758
Total research and development | ​ | $ | 6,916,181 | ​ | $ | 15,594,442
​ | ​ | ​ | ​ | ​ | ​ | ​
Selling, general and administrative | ​ |  |  | ​ |  |
Commission expense | ​ | $ | 2,903,705 | ​ | $ | 2,289,773
Royalty expense | ​ |  | 1,869,016 | ​ |  | 2,156,323
Stock-based compensation | ​ |  | 3,759,534 | ​ |  | 4,155,341
Legal, financial and consulting | ​ |  | 3,178,787 | ​ |  | 4,272,296
Other general and administrative | ​ |  | 23,244,707 | ​ |  | 25,433,682
Total selling, general and administrative | ​ | $ | 34,995,749 | ​ | $ | 38,307,415
* See Note 12 – Restatement of Previously Issued financial information for details.

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- Definition Tabular disclosure of the profit or loss and total assets for each reportable segment. An entity discloses certain information on each reportable segment if the amounts (a) are included in the measure of segment profit or loss reviewed by the chief operating decision maker or (b) are otherwise regularly provided to the chief operating decision maker, even if not included in that measure of segment profit or loss. + References Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef -Name Accounting Standards Codification -Topic 280 -SubTopic 10 -Section 50 -Paragraph 25 -Publisher FASB -URI https://asc.fasb.org/1943274/2147482810/280-10-50-25 Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef -Name Accounting Standards Codification -Topic 280 -SubTopic 10 -Section 50 -Paragraph 22 -Publisher FASB -URI https://asc.fasb.org/1943274/2147482810/280-10-50-22 Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef -Name Accounting Standards Codification -Topic 280 -SubTopic 10 -Section 50 -Paragraph 30 -Publisher FASB -URI https://asc.fasb.org/1943274/2147482810/280-10-50-30 + Details
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