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, 2023
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
Research and development expenses
|
|
$ |
745,758 |
|
|
$ |
83,855 |
|
|
$ |
— |
|
|
$ |
829,613 |
|
Selling, general and administrative expenses, excluding depreciation and amortization (1)
|
|
|
— |
|
|
|
1,772 |
|
|
|
1,272,926 |
|
|
|
1,274,698 |
|
Depreciation and amortization (2)
|
|
|
9,526 |
|
|
|
— |
|
|
|
17,501 |
|
|
|
27,027 |
|
Loss from operations (3)
|
|
|
(755,284 |
)
|
|
|
(85,627 |
)
|
|
|
(1,290,427 |
)
|
|
|
(2,131,338 |
)
|
Other expense, net (4)
|
|
|
— |
|
|
|
— |
|
|
|
(124,001 |
)
|
|
|
(124,001 |
)
|
Loss from continuing operations
|
|
|
(755,284 |
)
|
|
|
(85,627 |
)
|
|
|
(1,414,428 |
)
|
|
|
(2,255,339 |
)
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
5,130,396 |
|
|
$ |
5,130,396 |
|
International
|
|
|
559,455 |
|
|
|
— |
|
|
|
12,568 |
|
|
|
572,023 |
|
Three Months Ended September 30, 2022
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
Sales revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
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 |
|
Nine Months Ended September 30, 2023
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
Research and development expenses
|
|
$ |
2,973,357 |
|
|
$ |
229,974 |
|
|
$ |
— |
|
|
$ |
3,203,331 |
|
Selling, general and administrative expenses, excluding depreciation and amortization (1)
|
|
|
— |
|
|
|
4,832 |
|
|
|
3,691,525 |
|
|
|
3,696,357 |
|
Depreciation and amortization (2)
|
|
|
28,328 |
|
|
|
— |
|
|
|
53,389 |
|
|
|
81,717 |
|
Loss from operations (3)
|
|
|
(3,001,685 |
)
|
|
|
(234,806 |
)
|
|
|
(3,744,914 |
)
|
|
|
(6,981,405 |
)
|
Other income, net (4)
|
|
|
— |
|
|
|
— |
|
|
|
1,856,552 |
|
|
|
1,856,552 |
|
Loss from continuing operations
|
|
|
(3,001,685 |
)
|
|
|
(234,806 |
)
|
|
|
(1,888,362 |
)
|
|
|
(5,124,853 |
)
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
5,130,396 |
|
|
$ |
5,130,396 |
|
International
|
|
|
559,455 |
|
|
|
— |
|
|
|
12,568 |
|
|
|
572,023 |
|
Capital expenditures
|
|
|
15,068 |
|
|
|
— |
|
|
|
— |
|
|
|
15,068 |
|
Nine Months Ended September 30, 2022
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
Sales revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
(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 ($27,027 and $24,703 for the three-month periods ended September 30, 2023 and 2022, and $81,717 and $69,352 for the nine-month periods ended September 30, 2023 and 2022, 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 gain on contract amendment, gain on sale of non-financial asset, loss on debt extinguishment, adjustment of accrued interest, interest income and interest expense, which are not currently allocated to our individual reportable segments.
|
|