Quarterly report pursuant to Section 13 or 15(d)

Segments

v3.5.0.2
Segments
6 Months Ended
Jun. 30, 2016
Segment Reporting [Abstract]  
Segments

13.

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 June 30, 2016

 

Diagnostics

 

 

Therapeutics

 

 

Corporate

 

 

Total

 

Lymphoseek sales revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States (1)

 

$

4,218,606

 

 

$

 

 

$

 

 

$

4,218,606

 

International

 

 

13,113

 

 

 

 

 

 

 

 

 

13,113

 

Lymphoseek license revenue

 

 

245,950

 

 

 

 

 

 

 

 

 

245,950

 

Grant and other revenue

 

 

865,359

 

 

 

51,452

 

 

 

 

 

 

916,811

 

Total revenue

 

 

5,343,028

 

 

 

51,452

 

 

 

 

 

 

5,394,480

 

Cost of goods sold, excluding depreciation and amortization

 

 

546,466

 

 

 

 

 

 

 

 

 

546,466

 

Research and development expenses,

   excluding depreciation and amortization

 

 

2,414,255

 

 

 

111,326

 

 

 

 

 

 

2,525,581

 

Selling, general and administrative expenses,

   excluding depreciation and amortization (2)

 

 

1,135,558

 

 

 

4,430

 

 

 

1,644,649

 

 

 

2,784,637

 

Depreciation and amortization (3)

 

 

14,274

 

 

 

 

 

 

103,504

 

 

 

117,778

 

Income (loss) from operations (4)

 

 

1,232,475

 

 

 

(64,304

)

 

 

(1,748,153

)

 

 

(579,982

)

Other income (expense), excluding

   equity in the loss of R-NAV, LLC (5)

 

 

 

 

 

 

 

 

(6,098,405

)

 

 

(6,098,405

)

Equity in the loss of R-NAV, LLC

 

 

 

 

 

 

 

 

(2,920

)

 

 

(2,920

)

Net income (loss)

 

 

1,232,475

 

 

 

(64,304

)

 

 

(7,849,478

)

 

 

(6,681,307

)

Total assets, net of depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

4,621,738

 

 

 

36,841

 

 

 

3,701,620

 

 

 

8,360,199

 

International

 

 

321,359

 

 

 

 

 

 

591

 

 

 

321,950

 

Capital expenditures

 

 

 

 

 

 

 

 

1,847

 

 

 

1,847

 

 

Three Months Ended June 30, 2015

 

Diagnostics

 

 

Therapeutics

 

 

Corporate

 

 

Total

 

Lymphoseek sales revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States (1)

 

$

1,962,898

 

 

$

 

 

$

 

 

$

1,962,898

 

International

 

 

650

 

 

 

 

 

 

 

 

 

650

 

Lymphoseek license revenue

 

 

250,000

 

 

 

 

 

 

 

 

 

250,000

 

Grant and other revenue

 

 

654,360

 

 

 

 

 

 

 

 

 

654,360

 

Total revenue

 

 

2,867,908

 

 

 

 

 

 

 

 

 

2,867,908

 

Cost of goods sold, excluding depreciation and amortization

 

 

304,495

 

 

 

 

 

 

 

 

 

304,495

 

Research and development expenses,

   excluding depreciation and amortization

 

 

2,115,786

 

 

 

176,738

 

 

 

 

 

 

2,292,524

 

Selling, general and administrative expenses,

   excluding depreciation and amortization (2)

 

 

1,529,042

 

 

 

64,018

 

 

 

2,339,207

 

 

 

3,932,267

 

Depreciation and amortization (3)

 

 

32,785

 

 

 

 

 

 

116,532

 

 

 

149,317

 

Loss from operations (4)

 

 

(1,114,200

)

 

 

(240,756

)

 

 

(2,455,739

)

 

 

(3,810,695

)

Other income (expense), excluding

   equity in the loss of R-NAV, LLC (5)

 

 

 

 

 

 

 

 

(5,874,019

)

 

 

(5,874,019

)

Equity in the loss of R-NAV, LLC

 

 

 

 

 

 

 

 

(6,205

)

 

 

(6,205

)

Net loss

 

 

(1,114,200

)

 

 

(240,756

)

 

 

(8,335,963

)

 

 

(9,690,919

)

Total assets, net of depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

4,035,926

 

 

 

 

 

 

17,690,779

 

 

 

21,726,705

 

International

 

 

470,033

 

 

 

 

 

 

1,851

 

 

 

471,884

 

Capital expenditures

 

 

25,492

 

 

 

 

 

 

2,126

 

 

 

27,618

 

 

Six Months Ended June 30, 2016

 

Diagnostics

 

 

Therapeutics

 

 

Corporate

 

 

Total

 

Lymphoseek sales revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States (1)

 

$

7,990,026

 

 

$

 

 

$

 

 

$

7,990,026

 

International

 

 

24,373

 

 

 

 

 

 

 

 

 

24,373

 

Lymphoseek license revenue

 

 

500,000

 

 

 

 

 

 

 

 

 

500,000

 

Grant and other revenue

 

 

1,551,184

 

 

 

51,452

 

 

 

 

 

 

1,602,636

 

Total revenue

 

 

10,065,583

 

 

 

51,452

 

 

 

 

 

 

10,117,035

 

Cost of goods sold, excluding depreciation and amortization

 

 

1,041,105

 

 

 

 

 

 

 

 

 

1,041,105

 

Research and development expenses,

   excluding depreciation and amortization

 

 

4,831,975

 

 

 

353,126

 

 

 

 

 

 

5,185,101

 

Selling, general and administrative expenses,

   excluding depreciation and amortization (2)

 

 

2,147,664

 

 

 

3,832

 

 

 

4,620,499

 

 

 

6,771,995

 

Depreciation and amortization (3)

 

 

54,564

 

 

 

 

 

 

212,806

 

 

 

267,370

 

Income (loss) from operations (4)

 

 

1,990,275

 

 

 

(305,506

)

 

 

(4,833,305

)

 

 

(3,148,536

)

Other income (expense), excluding

   equity in the loss of R-NAV, LLC (5)

 

 

 

 

 

 

 

 

(7,203,861

)

 

 

(7,203,861

)

Equity in the loss of R-NAV, LLC

 

 

 

 

 

 

 

 

(15,159

)

 

 

(15,159

)

Net income (loss)

 

 

1,990,275

 

 

 

(305,506

)

 

 

(12,052,325

)

 

 

(10,367,556

)

Total assets, net of depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

4,621,738

 

 

 

36,841

 

 

 

3,701,620

 

 

 

8,360,199

 

International

 

 

321,359

 

 

 

 

 

 

591

 

 

 

321,950

 

Capital expenditures

 

 

 

 

 

 

 

 

1,847

 

 

 

1,847

 

 

Six Months Ended June 30, 2015

 

Diagnostics

 

 

Therapeutics

 

 

Corporate

 

 

Total

 

Lymphoseek sales revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States (1)

 

$

3,793,920

 

 

$

 

 

$

 

 

$

3,793,920

 

International

 

 

5,050

 

 

 

 

 

 

 

 

 

5,050

 

Lymphoseek license revenue

 

 

333,333

 

 

 

 

 

 

 

 

 

333,333

 

Grant and other revenue

 

 

844,061

 

 

 

 

 

 

 

 

 

844,061

 

Total revenue

 

 

4,976,364

 

 

 

 

 

 

 

 

 

4,976,364

 

Cost of goods sold, excluding depreciation and amortization

 

 

725,046

 

 

 

 

 

 

 

 

 

725,046

 

Research and development expenses,

   excluding depreciation and amortization

 

 

6,006,510

 

 

 

262,752

 

 

 

 

 

 

6,269,262

 

Selling, general and administrative expenses,

   excluding depreciation and amortization (2)

 

 

3,571,217

 

 

 

78,384

 

 

 

5,660,068

 

 

 

9,309,669

 

Depreciation and amortization (3)

 

 

65,841

 

 

 

 

 

 

233,298

 

 

 

299,139

 

Loss from operations (4)

 

 

(5,392,250

)

 

 

(341,136

)

 

 

(5,893,366

)

 

 

(11,626,752

)

Other income (expense), excluding

   equity in the loss of R-NAV, LLC (5)

 

 

 

 

 

 

 

 

(5,086,960

)

 

 

(5,086,960

)

Equity in the loss of R-NAV, LLC

 

 

 

 

 

 

 

 

(268,432

)

 

 

(268,432

)

Net loss

 

 

(5,392,250

)

 

 

(341,136

)

 

 

(11,248,758

)

 

 

(16,982,144

)

Total assets, net of depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

4,035,926

 

 

 

 

 

 

17,690,779

 

 

 

21,726,705

 

International

 

 

470,033

 

 

 

 

 

 

1,851

 

 

 

471,884

 

Capital expenditures

 

 

25,492

 

 

 

 

 

 

2,126

 

 

 

27,618

 

 

 

(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 ($14,274 and $28,235 for the three-month periods ended June 30, 2016 and 2015, and $54,564 and $56,741 for the six-month periods ended June 30, 2016 and 2015), research and development ($0 and $4,550 for the three-month periods ended June 30, 2016 and 2015, and $0 and $9,100 for the six-month periods ended June 30, 2016 and 2015), and selling, general and administrative expenses ($103,504 and $116,532 for the three-month periods ended June 30, 2016 and 2015, and $212,806 and $233,298 for the six-month periods ended June 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.