Segment Reporting Disclosure [Text Block] |
We report information about our operating segments using the “management approach” in accordance with current accounting standards. This information is based on the way management organizes and reports the segments within the enterprise for making operating decisions and assessing performance. Our reportable segments are identified based on differences in products, services and markets served. There were no inter-segment sales. We manage our business based on two primary types of drug products: (i) diagnostic substances, including Tc99m tilmanocept and other diagnostic applications of our Manocept platform, and (ii) therapeutic development programs, including therapeutic applications of our Manocept platform.
The information in the following tables is derived directly from each reportable segment’s financial reporting.
Three Months Ended September 30, 2022 |
|
Diagnostics |
|
|
Therapeutics |
|
|
Corporate |
|
|
Total |
|
Sales revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
International |
|
|
7,516 |
|
|
|
— |
|
|
|
— |
|
|
|
7,516 |
|
Grant and other revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total revenue |
|
|
7,516 |
|
|
|
— |
|
|
|
— |
|
|
|
7,516 |
|
Cost of revenue, excluding depreciation and amortization |
|
|
1,432 |
|
|
|
— |
|
|
|
— |
|
|
|
1,432 |
|
Reserve for expiring inventory |
|
|
133,006 |
|
|
|
— |
|
|
|
— |
|
|
|
133,006 |
|
Research and development expenses |
|
|
1,073,950 |
|
|
|
112,469 |
|
|
|
— |
|
|
|
1,186,419 |
|
Selling, general and administrative expenses, excluding depreciation and amortization (1) |
|
|
— |
|
|
|
745 |
|
|
|
3,612,002 |
|
|
|
3,612,747 |
|
Depreciation and amortization (2) |
|
|
8,532 |
|
|
|
— |
|
|
|
16,171 |
|
|
|
24,703 |
|
Income (loss) from operations (3) |
|
|
(1,209,404 |
) |
|
|
(113,214 |
) |
|
|
(3,628,173 |
) |
|
|
(4,950,791 |
) |
Other expense, net (4) |
|
|
— |
|
|
|
— |
|
|
|
(757,034 |
) |
|
|
(757,034 |
) |
Net loss |
|
|
(1,209,404 |
) |
|
|
(113,214 |
) |
|
|
(4,385,207 |
) |
|
|
(5,707,825 |
) |
Total assets, net of depreciation and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
50,000 |
|
|
$ |
— |
|
|
$ |
5,929,692 |
|
|
$ |
5,979,692 |
|
International |
|
|
271,939 |
|
|
|
— |
|
|
|
6,801 |
|
|
|
278,740 |
|
Capital expenditures |
|
|
14,429 |
|
|
|
— |
|
|
|
— |
|
|
|
14,429 |
|
Three Months Ended September 30, 2021 |
|
Diagnostics |
|
|
Therapeutics |
|
|
Corporate |
|
|
Total |
|
License revenue |
|
$ |
9,116 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,116 |
|
Grant and other revenue |
|
|
87,266 |
|
|
|
— |
|
|
|
— |
|
|
|
87,266 |
|
Total revenue |
|
|
96,382 |
|
|
|
— |
|
|
|
— |
|
|
|
96,382 |
|
Research and development expenses |
|
|
906,677 |
|
|
|
142,109 |
|
|
|
— |
|
|
|
1,048,786 |
|
Selling, general and administrative expenses, excluding depreciation and amortization (1) |
|
|
— |
|
|
|
744 |
|
|
|
1,450,565 |
|
|
|
1,451,309 |
|
Depreciation and amortization (2) |
|
|
6,040 |
|
|
|
— |
|
|
|
12,026 |
|
|
|
18,066 |
|
Loss from operations (3) |
|
|
(816,335 |
) |
|
|
(142,853 |
) |
|
|
(1,462,591 |
) |
|
|
(2,421,779 |
) |
Other expense, net (4) |
|
|
— |
|
|
|
— |
|
|
|
(14 |
) |
|
|
(14 |
) |
Income tax expense |
|
|
(5,763 |
) |
|
|
(824 |
) |
|
|
(9,457 |
) |
|
|
(16,043 |
) |
Net loss |
|
|
(822,098 |
) |
|
|
(143,677 |
) |
|
|
(1,472,062 |
) |
|
|
(2,437,836 |
) |
Total assets, net of depreciation and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
185,205 |
|
|
$ |
— |
|
|
$ |
8,557,398 |
|
|
$ |
8,742,603 |
|
International |
|
|
216,353 |
|
|
|
— |
|
|
|
590 |
|
|
|
216,943 |
|
Capital expenditures |
|
|
— |
|
|
|
— |
|
|
|
18,042 |
|
|
|
18,042 |
|
Nine Months Ended September 30, 2022 |
|
Diagnostics |
|
|
Therapeutics |
|
|
Corporate |
|
|
Total |
|
Sales revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
International |
|
|
14,035 |
|
|
|
— |
|
|
|
— |
|
|
|
14,035 |
|
Grant and other revenue |
|
|
51,007 |
|
|
|
— |
|
|
|
— |
|
|
|
51,007 |
|
Total revenue |
|
|
65,042 |
|
|
|
— |
|
|
|
— |
|
|
|
65,042 |
|
Cost of revenue, excluding depreciation and amortization |
|
|
1,905 |
|
|
|
— |
|
|
|
— |
|
|
|
1,905 |
|
Reserve for expiring inventory |
|
|
133,006 |
|
|
|
— |
|
|
|
— |
|
|
|
133,006 |
|
Research and development expenses |
|
|
3,700,528 |
|
|
|
379,133 |
|
|
|
— |
|
|
|
4,079,661 |
|
Selling, general and administrative expenses, excluding depreciation and amortization (1) |
|
|
— |
|
|
|
3,746 |
|
|
|
6,630,047 |
|
|
|
6,633,793 |
|
Depreciation and amortization (2) |
|
|
20,613 |
|
|
|
— |
|
|
|
48,739 |
|
|
|
69,352 |
|
Loss from operations (3) |
|
|
(3,791,010 |
) |
|
|
(382,879 |
) |
|
|
(6,678,786 |
) |
|
|
(10,852,675 |
) |
Other expense, net (4) |
|
|
— |
|
|
|
— |
|
|
|
(841,853 |
) |
|
|
(841,853 |
) |
Net loss |
|
|
(3,791,010 |
) |
|
|
(382,879 |
) |
|
|
(7,520,639 |
) |
|
|
(11,694,528 |
) |
Total assets, net of depreciation and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
50,000 |
|
|
$ |
— |
|
|
$ |
5,929,692 |
|
|
$ |
5,979,692 |
|
International |
|
|
271,939 |
|
|
|
— |
|
|
|
6,801 |
|
|
|
278,740 |
|
Capital expenditures |
|
|
54,650 |
|
|
|
— |
|
|
|
8,436 |
|
|
|
63,086 |
|
Nine Months Ended September 30, 2021 |
|
Diagnostics |
|
|
Therapeutics |
|
|
Corporate |
|
|
Total |
|
License revenue |
|
$ |
44,665 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
44,665 |
|
Grant and other revenue |
|
|
436,500 |
|
|
|
— |
|
|
|
— |
|
|
|
436,500 |
|
Total revenue |
|
|
481,165 |
|
|
|
— |
|
|
|
— |
|
|
|
481,165 |
|
Research and development expenses |
|
|
3,359,190 |
|
|
|
410,406 |
|
|
|
— |
|
|
|
3,769,596 |
|
Selling, general and administrative expenses, excluding depreciation and amortization (1) |
|
|
— |
|
|
|
3,623 |
|
|
|
5,073,435 |
|
|
|
5,077,058 |
|
Depreciation and amortization (2) |
|
|
18,121 |
|
|
|
— |
|
|
|
37,551 |
|
|
|
55,672 |
|
Loss from operations (3) |
|
|
(2,896,146 |
) |
|
|
(414,029 |
) |
|
|
(5,110,986 |
) |
|
|
(8,421,161 |
) |
Other income, net (4) |
|
|
— |
|
|
|
— |
|
|
|
358,436 |
|
|
|
358,436 |
|
Income tax expense |
|
|
(5,763 |
) |
|
|
(824 |
) |
|
|
(9,457 |
) |
|
|
(16,043 |
) |
Net loss |
|
|
(2,901,909 |
) |
|
|
(414,853 |
) |
|
|
(4,762,007 |
) |
|
|
(8,078,768 |
) |
Total assets, net of depreciation and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
185,205 |
|
|
$ |
— |
|
|
$ |
8,557,398 |
|
|
$ |
8,742,603 |
|
International |
|
|
216,353 |
|
|
|
— |
|
|
|
590 |
|
|
|
216,943 |
|
Capital expenditures |
|
|
— |
|
|
|
— |
|
|
|
20,749 |
|
|
|
20,749 |
|
|
(1) |
General and administrative expenses, excluding depreciation and amortization, represent costs that relate to the general administration of the Company and as such are not currently allocated to our individual reportable segments, other than those expenses directly incurred by Navidea Europe, Navidea UK and MT. |
|
(2) |
Depreciation and amortization are reflected in selling, general and administrative expenses ($24,703 and $18,066 for the three-month periods ended September 30, 2022 and 2021, and $69,352 and $55,672 for the nine-month periods ended September 30, 2022 and 2021, respectively). |
|
(3) |
Loss from operations does not reflect the allocation of certain selling, general and administrative expenses, excluding depreciation and amortization, to our individual reportable segments, other than those expenses directly incurred by Navidea Europe, Navidea UK and MT. |
|
(4) |
Amounts consist primarily of interest income and interest expense, which are not currently allocated to our individual reportable segments. |
|