Quarterly report pursuant to Section 13 or 15(d)

Segments

v3.5.0.2
Segments
9 Months Ended
Sep. 30, 2016
Segment Reporting [Abstract]  
Segments

14.

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.