| Segments |
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. Prior to 2015, our products and development programs were all related to diagnostic substances. Our majority-owned subsidiary, Macrophage Therapeutics, Inc., was formed and received initial funding during the first quarter of 2015, which resulted in a re-evaluation of the Company's segment determination. We now manage our business based on two primary types of drug products: (i) diagnostic substances, including Lymphoseek and other diagnostic applications of our Manocept platform, our R-NAV joint venture (terminated on May 31, 2016), NAV4694 and NAV5001 (license terminated in April 2015), and (ii) therapeutic development programs, including therapeutic applications of our Manocept platform and all development programs undertaken by Macrophage Therapeutics, Inc.
The information in the following tables is derived directly from each reportable segment’s financial reporting.
|
Three Months Ended September 30, 2016
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
|
Lymphoseek sales revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States (1)
|
|
$
|
6,670,644
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,670,644
|
|
|
International
|
|
|
19,446
|
|
|
|
—
|
|
|
|
—
|
|
|
|
19,446
|
|
|
Lymphoseek license revenue
|
|
|
1,295,625
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,295,625
|
|
|
Grant and other revenue
|
|
|
501,013
|
|
|
|
10,346
|
|
|
|
—
|
|
|
|
511,359
|
|
|
Total revenue
|
|
|
8,486,728
|
|
|
|
10,346
|
|
|
|
—
|
|
|
|
8,497,074
|
|
|
Cost of goods sold, excluding depreciation and amortization
|
|
|
909,539
|
|
|
|
—
|
|
|
|
—
|
|
|
|
909,539
|
|
|
Research and development expenses, excluding
depreciation and amortization
|
|
|
1,028,389
|
|
|
|
247,664
|
|
|
|
—
|
|
|
|
1,276,053
|
|
|
Selling, general and administrative expenses, excluding
depreciation and amortization (2)
|
|
|
839,410
|
|
|
|
27,758
|
|
|
|
1,974,419
|
|
|
|
2,841,587
|
|
|
Depreciation and amortization (3)
|
|
|
12,278
|
|
|
|
—
|
|
|
|
99,186
|
|
|
|
111,464
|
|
|
Income (loss) from operations (4)
|
|
|
5,697,112
|
|
|
|
(265,076
|
)
|
|
|
(2,073,605
|
)
|
|
|
3,358,431
|
|
|
Other income (expense), excluding equity in the loss of
R-NAV, LLC (5)
|
|
|
—
|
|
|
|
—
|
|
|
|
(3,417,967
|
)
|
|
|
(3,417,967
|
)
|
|
Net income (loss)
|
|
|
5,697,112
|
|
|
|
(265,076
|
)
|
|
|
(5,491,572
|
)
|
|
|
(59,536
|
)
|
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
|
4,673,425
|
|
|
|
9,356
|
|
|
|
6,357,898
|
|
|
|
11,040,679
|
|
|
International
|
|
|
148,224
|
|
|
|
—
|
|
|
|
697
|
|
|
|
148,921
|
|
|
Capital expenditures
|
|
|
—
|
|
|
|
—
|
|
|
|
1,847
|
|
|
|
1,847
|
|
|
Three Months Ended September 30, 2015
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
|
Lymphoseek sales revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States (1)
|
|
$
|
2,942,498
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,942,498
|
|
|
International
|
|
|
10,024
|
|
|
|
—
|
|
|
|
—
|
|
|
|
10,024
|
|
|
Lymphoseek license revenue
|
|
|
550,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
550,000
|
|
|
Grant and other revenue
|
|
|
476,755
|
|
|
|
—
|
|
|
|
—
|
|
|
|
476,755
|
|
|
Total revenue
|
|
|
3,979,277
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,979,277
|
|
|
Cost of goods sold, excluding depreciation and amortization
|
|
|
442,094
|
|
|
|
—
|
|
|
|
—
|
|
|
|
442,094
|
|
|
Research and development expenses, excluding
depreciation and amortization
|
|
|
3,603,501
|
|
|
|
297,137
|
|
|
|
—
|
|
|
|
3,900,638
|
|
|
Selling, general and administrative expenses, excluding
depreciation and amortization (2)
|
|
|
1,063,062
|
|
|
|
42,487
|
|
|
|
2,721,844
|
|
|
|
3,827,393
|
|
|
Depreciation and amortization (3)
|
|
|
17,013
|
|
|
|
—
|
|
|
|
115,216
|
|
|
|
132,229
|
|
|
Loss from operations (4)
|
|
|
(1,146,393
|
)
|
|
|
(339,624
|
)
|
|
|
(2,837,060
|
)
|
|
|
(4,323,077
|
)
|
|
Other income (expense), excluding equity in the loss of
R-NAV, LLC (5)
|
|
|
—
|
|
|
|
—
|
|
|
|
(3,721,242
|
)
|
|
|
(3,721,242
|
)
|
|
Equity in the loss of R-NAV, LLC
|
|
|
—
|
|
|
|
—
|
|
|
|
(26,785
|
)
|
|
|
(26,785
|
)
|
|
Net loss
|
|
|
(1,146,393
|
)
|
|
|
(339,624
|
)
|
|
|
(6,585,087
|
)
|
|
|
(8,071,104
|
)
|
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
|
3,750,702
|
|
|
|
—
|
|
|
|
13,291,939
|
|
|
|
17,042,641
|
|
|
International
|
|
|
440,349
|
|
|
|
—
|
|
|
|
467
|
|
|
|
440,816
|
|
|
Capital expenditures
|
|
|
—
|
|
|
|
—
|
|
|
|
2,788
|
|
|
|
2,788
|
|
|
Nine Months Ended September 30, 2016
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
|
Lymphoseek sales revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States (1)
|
|
$
|
14,660,670
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,660,670
|
|
|
International
|
|
|
43,819
|
|
|
|
—
|
|
|
|
—
|
|
|
|
43,819
|
|
|
Lymphoseek license revenue
|
|
|
1,795,625
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,795,625
|
|
|
Grant and other revenue
|
|
|
2,052,197
|
|
|
|
61,798
|
|
|
|
—
|
|
|
|
2,113,995
|
|
|
Total revenue
|
|
|
18,552,311
|
|
|
|
61,798
|
|
|
|
—
|
|
|
|
18,614,109
|
|
|
Cost of goods sold, excluding depreciation and amortization
|
|
|
1,950,644
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,950,644
|
|
|
Research and development expenses, excluding
depreciation and amortization
|
|
|
5,860,364
|
|
|
|
600,790
|
|
|
|
—
|
|
|
|
6,461,154
|
|
|
Selling, general and administrative expenses, excluding
depreciation and amortization (2)
|
|
|
2,987,074
|
|
|
|
31,590
|
|
|
|
6,594,918
|
|
|
|
9,613,582
|
|
|
Depreciation and amortization (3)
|
|
|
66,842
|
|
|
|
—
|
|
|
|
311,992
|
|
|
|
378,834
|
|
|
Income (loss) from operations (4)
|
|
|
7,687,387
|
|
|
|
(570,582
|
)
|
|
|
(6,906,910
|
)
|
|
|
209,895
|
|
|
Other income (expense), excluding equity in the loss of
R-NAV, LLC (5)
|
|
|
—
|
|
|
|
—
|
|
|
|
(10,621,828
|
)
|
|
|
(10,621,828
|
)
|
|
Equity in the loss of R-NAV, LLC
|
|
|
—
|
|
|
|
—
|
|
|
|
(15,159
|
)
|
|
|
(15,159
|
)
|
|
Net income (loss)
|
|
|
7,687,387
|
|
|
|
(570,582
|
)
|
|
|
(17,543,897
|
)
|
|
|
(10,427,092
|
)
|
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
|
4,673,425
|
|
|
|
9,356
|
|
|
|
6,357,898
|
|
|
|
11,040,679
|
|
|
International
|
|
|
148,224
|
|
|
|
—
|
|
|
|
697
|
|
|
|
148,921
|
|
|
Capital expenditures
|
|
|
—
|
|
|
|
—
|
|
|
|
1,847
|
|
|
|
1,847
|
|
|
Nine Months Ended September 30, 2015
|
|
Diagnostics
|
|
|
Therapeutics
|
|
|
Corporate
|
|
|
Total
|
|
|
Lymphoseek sales revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States (1)
|
|
$
|
6,736,418
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,736,418
|
|
|
International
|
|
|
15,074
|
|
|
|
—
|
|
|
|
—
|
|
|
|
15,074
|
|
|
Lymphoseek license revenue
|
|
|
883,333
|
|
|
|
—
|
|
|
|
—
|
|
|
|
883,333
|
|
|
Grant and other revenue
|
|
|
1,320,816
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,320,816
|
|
|
Total revenue
|
|
|
8,955,641
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,955,641
|
|
|
Cost of goods sold, excluding depreciation and amortization
|
|
|
1,167,141
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,167,141
|
|
|
Research and development expenses, excluding
depreciation and amortization
|
|
|
9,610,012
|
|
|
|
559,888
|
|
|
|
—
|
|
|
|
10,169,900
|
|
|
Selling, general and administrative expenses, excluding
depreciation and amortization (2)
|
|
|
4,634,279
|
|
|
|
120,872
|
|
|
|
8,381,910
|
|
|
|
13,137,061
|
|
|
Depreciation and amortization (3)
|
|
|
207,498
|
|
|
|
—
|
|
|
|
223,870
|
|
|
|
431,368
|
|
|
Loss from operations (4)
|
|
|
(6,663,289
|
)
|
|
|
(680,760
|
)
|
|
|
(8,605,780
|
)
|
|
|
(15,949,829
|
)
|
|
Other income (expense), excluding equity in the loss of
R-NAV, LLC (5)
|
|
|
—
|
|
|
|
—
|
|
|
|
(8,808,202
|
)
|
|
|
(8,808,202
|
)
|
|
Equity in the loss of R-NAV, LLC
|
|
|
—
|
|
|
|
—
|
|
|
|
(295,217
|
)
|
|
|
(295,217
|
)
|
|
Net loss
|
|
|
(6,663,289
|
)
|
|
|
(680,760
|
)
|
|
|
(17,709,199
|
)
|
|
|
(25,053,248
|
)
|
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
|
3,750,702
|
|
|
|
—
|
|
|
|
13,291,939
|
|
|
|
17,042,641
|
|
|
International
|
|
|
440,349
|
|
|
|
—
|
|
|
|
467
|
|
|
|
440,816
|
|
|
Capital expenditures
|
|
|
25,492
|
|
|
|
—
|
|
|
|
4,914
|
|
|
|
30,406
|
|
|
|
(1)
|
All sales to Cardinal Health are made in the United States; Cardinal distributes the product throughout the U.S. through its network of nuclear pharmacies.
|
|
|
(2)
|
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. Marketing and selling expenses are allocated to our individual reportable segments.
|
|
|
(3)
|
Depreciation and amortization is reflected in cost of goods sold ($12,278 and $15,496 for the three-month periods ended September 30, 2016 and 2015, and $66,842 and $72,237 for the nine-month periods ended September 30, 2016 and 2015), research and development ($0 and $1,517 for the three-month periods ended September 30, 2016 and 2015, and $0 and $10,617 for the nine-month periods ended September 30, 2016 and 2015), and selling, general and administrative expenses ($99,186 and $115,216 for the three-month periods ended September 30, 2016 and 2015, and $311,992 and $348,514 for the nine-month periods ended September 30, 2016 and 2015).
|
|
|
(4)
|
Loss from operations does not reflect the allocation of certain selling, general and administrative expenses, excluding depreciation and amortization, to our individual reportable segments.
|
|
|
(5)
|
Amounts consist primarily of interest income, interest expense, changes in fair value of financial instruments, and losses on debt extinguishment, which are not currently allocated to our individual reportable segments.
|
|