Delaware
|
|
31-1080091
|
(State or other jurisdiction of incorporation or
organization)
|
|
(I.R.S. Employer Identification No.)
|
|
|
|
5600 Blazer Parkway, Suite 200, Dublin, Ohio
|
|
43017-7550
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Common Stock, par value $.001 per share
|
|
NYSE MKT
|
(Title of Class)
|
|
(Name of Each Exchange on Which Registered)
|
Large
accelerated filer
|
☐
|
|
Accelerated
filer
|
☒
|
Non-accelerated
filer
|
☐
|
|
Smaller reporting
company
|
☐
|
|
High
|
Low
|
Fiscal Year 2016:
|
|
|
First Quarter
|
$1.35
|
$0.75
|
Second Quarter
|
1.51
|
0.51
|
Third Quarter
|
1.14
|
0.26
|
Fourth Quarter
|
1.16
|
0.57
|
|
|
|
Fiscal Year 2015:
|
|
|
First Quarter
|
$1.96
|
$1.55
|
Second Quarter
|
1.67
|
1.22
|
Third Quarter
|
2.50
|
1.28
|
Fourth Quarter
|
2.40
|
1.32
|
|
Cumulative Total Return as of December 31,
|
|||||
|
2011
|
2012
|
2013
|
2014
|
2015
|
2016
|
Navidea Biopharmaceuticals
|
$100.00
|
$108.02
|
$79.01
|
$72.14
|
$50.76
|
$24.43
|
Russell 3000
|
100.00
|
113.98
|
149.25
|
164.85
|
162.42
|
179.34
|
NASDAQ Biotechnology
|
100.00
|
131.91
|
218.45
|
292.93
|
326.39
|
255.62
|
(Amounts in thousands, except per share data)
|
Years Ended December 31,
|
||||
|
2016
|
2015
|
2014
|
2013
|
2012
|
Statement of Operations Data:
|
|
|
|
|
|
Revenue
|
$21,970
|
$13,249
|
$6,275
|
$1,131
|
$79
|
Cost of goods sold
|
2,297
|
1,755
|
1,586
|
333
|
—
|
Research and development expenses
|
8,883
|
12,788
|
16,780
|
23,710
|
16,890
|
Selling, general and administrative expenses
|
13,013
|
17,257
|
15,542
|
15,526
|
11,178
|
Loss from operations
|
(2,223)
|
(18,551)
|
(27,633)
|
(38,438)
|
(27,989)
|
|
|
|
|
|
|
Other expenses, net
|
(12,086)
|
(10,208)
|
(8,094)
|
(4,261)
|
(1,168)
|
|
|
|
|
|
|
Benefit from income taxes
|
—
|
436
|
—
|
—
|
—
|
|
|
|
|
|
|
Loss from continuing operations
|
(14,309)
|
(28,323)
|
(35,727)
|
(42,699)
|
(29,157)
|
Discontinued operations, net of tax effect
|
—
|
759
|
—
|
—
|
—
|
|
|
|
|
|
|
Net loss
|
(14,309)
|
(27,564)
|
(35,727)
|
(42,699)
|
(29,157)
|
Less loss attributable to noncontrolling interest
|
(1)
|
(1)
|
—
|
—
|
—
|
Deemed dividend
|
—
|
(46)
|
—
|
—
|
—
|
Preferred stock dividends
|
—
|
—
|
—
|
—
|
(43)
|
|
|
|
|
|
|
Loss attributable to common stockholders
|
$(14,308)
|
$(27,609)
|
$(35,727)
|
$(42,699)
|
$(29,200)
|
|
|
|
|
|
|
(Loss) income per common share (basic and diluted):
|
|
|
|
|
|
Continuing operations
|
$(0.09)
|
$(0.19)
|
$(0.24)
|
$(0.35)
|
$(0.29)
|
Discontinued operations
|
$—
|
$0.01
|
$—
|
$—
|
$—
|
Loss attributable to common stockholders
|
$(0.09)
|
$(0.18)
|
$(0.24)
|
$(0.35)
|
$(0.29)
|
|
|
|
|
|
|
Shares used in computing (loss) income per common
share: (1)
|
|
|
|
|
|
Basic and diluted
|
155,422
|
151,180
|
148,748
|
121,809
|
99,060
|
|
As of December 31,
|
||||
|
2016
|
2015
|
2014
|
2013
|
2012
|
Balance Sheet Data:
|
|
|
|
|
|
Total assets$
|
12,462
|
$14,965
|
$11,830
|
$39,626
|
$11,677
|
Long-term liabilities
|
10,266
|
62,616
|
32,573
|
32,703
|
7,107
|
Accumulated deficit
|
(394,855)
|
(380,547)
|
(352,984)
|
(317,257)
|
(274,558)
|
Development Program *
|
2016
|
2015
|
2014
|
Tc 99m
tilmanocept
|
$2,002,449
|
$2,365,128
|
$995,511
|
Manocept platform
|
1,045,102
|
767,431
|
503,587
|
Macrophage Therapeutics
|
679,961
|
538,813
|
—
|
NAV4694
|
1,590,607
|
3,448,724
|
6,788,286
|
NAV5001
|
97,602
|
385,344
|
1,441,442
|
|
Payments Due By Period
|
||||||
Contractual Cash Obligations
|
Total
|
2017
|
2018
|
2019
|
2020
|
2021
|
Thereafter
|
Purchase obligations
|
$1,088,154
|
$1,088,154
|
$—
|
$—
|
$—
|
$—
|
$—
|
Operating lease obligation
|
1,707,871
|
277,946
|
284,246
|
290,734
|
297,405
|
304,201
|
253,339
|
Principal and interest on
short-term debt
|
315,610
|
315,610
|
—
|
—
|
—
|
—
|
—
|
Principal and interest on
long-term debt
(1)(2)
|
66,896,551
|
57,408,729
|
—
|
—
|
—
|
9,487,822
|
—
|
Total contractual cash
obligations
|
$70,008,186
|
$59,090,439
|
$284,246
|
$290,734
|
$297,405
|
$9,792,023
|
$253,339
|
Name
|
|
Age
|
|
Committee(s)
|
Anthony S.
Fiorino, M.D., Ph.D.
|
|
49
|
|
Audit
|
Michael M.
Goldberg, M.D.
|
|
58
|
|
—
|
Mark
I. Greene, M.D., Ph.D., FRCP
|
|
68
|
|
Compensation,
Nominating and Governance
|
Y.
Michael Rice
|
|
52
|
|
Audit
(Chairman); Compensation, Nominating and Governance
|
Eric
K. Rowinsky, M.D.
|
|
60
|
|
Audit;
Compensation, Nominating and Governance (Chairman)
|
Name
|
|
Age
|
|
Position
|
Frederick O. Cope,
Ph.D.
|
|
70
|
|
Senior
Vice President and Chief Scientific Officer
|
Jed A.
Latkin
|
|
42
|
|
Interim Chief
Operating Officer, Chief Financial Officer, Treasurer and
Secretary
|
William J.
Regan
|
|
65
|
|
Senior
Vice President and Chief
Compliance Officer
|
Sangamo
Biosciences, Inc.
|
|
ArQule,
Inc.
|
Inovio
Pharmaceuticals, Inc.
|
|
Galena
Biopharma, Inc.
|
Geron
Corporation
|
|
Keryx
Biopharmaceuticals, Inc.
|
Rigel
Pharmaceuticals, Inc.
|
|
BioTime,
Inc.
|
OncoMed
Pharmaceuticals, Inc.
|
|
Omeros
Corporation
|
CTI
BioPharma Corp.
|
|
Immunomedics,
Inc.
|
Unilife
Corporation
|
|
Nymox
Pharmaceutical Corporation
|
Named Executive Officer
|
Fiscal 2016
Base Salary(a)
|
Fiscal 2015
Base Salary
|
Change(b)
|
Michael M.
Goldberg, M.D. (c)
|
$400,000
|
$—
|
N/A
|
Ricardo J.
Gonzalez (d)
|
375,000
|
375,000
|
0.0%
|
Frederick O. Cope,
Ph.D.
|
279,130
|
279,130
|
0.0%
|
Thomas
J. Klima (e)
|
270,000
|
270,000
|
0.0%
|
Brent
L. Larson (f)
|
260,000
|
260,000
|
0.0%
|
Jed A.
Latkin (g)
|
300,000
|
—
|
N/A
|
William J.
Regan
|
250,000
|
250,000
|
0.0%
|
Named Executive Officer
|
Target Cash Bonus (% of Salary)
|
Target Cash Bonus ($ Amount)
|
Michael M.
Goldberg, M.D. (a)
|
75.0%
|
$300,000
|
Ricardo J.
Gonzalez (b)
|
50.0%
|
187,500
|
Frederick O. Cope,
Ph.D.
|
35.0%
|
97,696
|
Thomas
J. Klima (c)
|
35.0%
|
94,500
|
Brent
L. Larson (d)
|
35.0%
|
91,000
|
Jed A.
Latkin (e)
|
0.0%
|
—
|
William J.
Regan
|
35.0%
|
87,500
|
|
For Cause
|
Resignation
|
Death
|
Disability
|
End of Term
|
Without Cause
|
Change in Control
|
Cash
payments:
|
|
|
|
|
|
|
|
Severance
(a)
|
$—
|
$—
|
$—
|
$—
|
$800,000
|
$800,000
|
$1,100,000
|
Disability
supplement (b)
|
—
|
—
|
—
|
197,600
|
—
|
—
|
—
|
Paid
time off (c)
|
7,692
|
7,692
|
7,692
|
7,692
|
7,692
|
7,692
|
7,692
|
Continuation of
benefits (d)
|
—
|
—
|
26,858
|
26,858
|
—
|
—
|
—
|
Total
|
$7,692
|
$7,692
|
$36,750
|
$234,350
|
$807,692
|
$807,692
|
$1,107,692
|
|
For Cause
|
Resignation
|
Death
|
Disability
|
End of Term
|
Without Cause
|
Change in Control
|
Cash
payments:
|
|
|
|
|
|
|
|
Severance
(a)
|
$—
|
$—
|
$—
|
$—
|
$245,000
|
$245,000
|
$367,500
|
Disability
supplement (b)
|
—
|
—
|
—
|
137,165
|
—
|
—
|
—
|
Paid
time off (c)
|
5,368
|
5,368
|
5,368
|
5,368
|
5,368
|
5,368
|
5,368
|
2016
401(k) match (d)
|
5,300
|
5,300
|
5,300
|
5,300
|
5,300
|
5,300
|
5,300
|
Continuation of
benefits (e)
|
—
|
—
|
20,166
|
20,166
|
—
|
20,166
|
20,166
|
Stock
option vesting acceleration (f)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Restricted stock
vesting acceleration (g)
|
—
|
—
|
—
|
—
|
—
|
—
|
31,950
|
Total
|
$10,668
|
$10,668
|
$30,834
|
$167,999
|
$255,668
|
$275,834
|
$430,284
|
|
For Cause
|
Resignation
|
Death
|
Disability
|
End of Term
|
Without Cause
|
Change in Control
|
Cash
payments:
|
|
|
|
|
|
|
|
Disability
supplement (a)
|
$—
|
$—
|
$—
|
$132,600
|
$—
|
$—
|
$—
|
Paid
time off (b)
|
5,192
|
5,192
|
5,192
|
5,192
|
5,192
|
5,192
|
5,192
|
Continuation of
benefits (c)
|
—
|
—
|
14,529
|
14,529
|
—
|
—
|
—
|
Stock
option vesting acceleration (d)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Total
|
$5,192
|
$5,192
|
$19,721
|
$152,321
|
$5,192
|
$5,192
|
$5,192
|
|
For Cause
|
Resignation
|
Death
|
Disability
|
End of Term
|
Without Cause
|
Change in Control
|
Total
|
$—
|
$—
|
$—
|
$—
|
$—
|
$—
|
$—
|
|
For Cause
|
Resignation
|
Death
|
Disability
|
End of Term
|
Without Cause
|
Change in Control
|
Cash
payments:
|
|
|
|
|
|
|
|
Severance
(a)
|
$—
|
$—
|
$—
|
$—
|
$250,000
|
$250,000
|
$375,000
|
Disability
supplement (b)
|
—
|
—
|
—
|
122,600
|
—
|
—
|
—
|
Paid
time off (c)
|
4,808
|
4,808
|
4,808
|
4,808
|
4,808
|
4,808
|
4,808
|
2016
401(k) match (d)
|
5,036
|
5,036
|
5,036
|
5,036
|
5,036
|
5,036
|
5,036
|
Continuation of
benefits (e)
|
—
|
—
|
1,150
|
1,150
|
—
|
1,150
|
1,150
|
Stock
option vesting acceleration (f)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Total
|
$9,844
|
$9,844
|
$10,993
|
$133,593
|
$259,844
|
$260,993
|
$385,993
|
|
The
Compensation, Nominating
|
|
and
Governance Committee
|
|
|
|
Eric
K. Rowinsky, M.D. (Chairman)
|
|
Mark
I. Greene, M.D., Ph.D., FRCP
|
|
Y.
Michael Rice
|
Named Executive Officer
|
Year
|
Salary
|
(a)
Stock
Awards
|
(b)
Option
Awards
|
(c)
Non-Equity
Incentive Plan
Compensation
|
(d)
All Other
Compensation
|
TotalCompensation
|
Michael M.
Goldberg (e)
|
2016
|
$83,077
|
$—
|
$—
|
$—
|
$436
|
$83,513
|
President
and
|
2015
|
—
|
—
|
—
|
—
|
—
|
—
|
Chief
Executive Officer
|
2014
|
—
|
—
|
—
|
—
|
—
|
—
|
|
|
|
|
|
|
|
|
Ricardo J.
Gonzalez (f)
|
2016
|
$137,981
|
$—
|
$—
|
$—
|
$3,352
|
$141,333
|
President
and
|
2015
|
375,000
|
—
|
—
|
105,001
|
7,692
|
487,693
|
Chief
Executive Officer
|
2014
|
82,452
|
—
|
768,247
|
16,241
|
—
|
866,940
|
|
|
|
|
|
|
|
|
Frederick O. Cope,
Ph.D.
|
2016
|
$279,130
|
$—
|
$—
|
$54,710
|
$6,735
|
$340,575
|
Senior
Vice President and
|
2015
|
279,130
|
—
|
155,026
|
54,709
|
6,657
|
495,522
|
Chief
Scientific Officer
|
2014
|
279,130
|
—
|
144,067
|
27,913
|
6,173
|
457,283
|
|
|
|
|
|
|
|
|
Thomas
J. Klima (g)
|
2016
|
$270,000
|
$—
|
$—
|
$52,920
|
$2,326
|
$325,246
|
Senior
Vice President and
|
2015
|
270,000
|
192,900
|
112,163
|
52,921
|
3,114
|
631,098
|
Chief
Commercial Officer
|
2014
|
—
|
—
|
—
|
—
|
—
|
—
|
|
|
|
|
|
|
|
|
Brent
L. Larson (h)
|
2016
|
$188,393
|
$—
|
$—
|
$—
|
$5,826
|
$194,219
|
Executive Vice
President
|
2015
|
260,000
|
—
|
144,499
|
50,960
|
7,692
|
463,151
|
and
Chief Financial Officer
|
2014
|
260,000
|
—
|
134,318
|
17,875
|
6,727
|
418,920
|
|
|
|
|
|
|
|
|
Jed A.
Latkin (i)
|
2016
|
$163,309
|
$—
|
$39,992
|
$—
|
$—
|
$203,301
|
Interim Chief
Operating
|
2015
|
—
|
—
|
—
|
—
|
—
|
—
|
Officer and Chief
Financial
|
2014
|
—
|
—
|
—
|
—
|
—
|
—
|
Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
William J.
Regan
|
2016
|
$250,000
|
$—
|
$—
|
$49,000
|
$6,142
|
$305,142
|
Senior
Vice President and
|
2015
|
250,000
|
—
|
157,896
|
49,001
|
6,410
|
463,307
|
Chief
Compliance Officer
|
2014
|
250,000
|
—
|
113,587
|
25,000
|
6,280
|
394,867
|
Named Executive Officer
|
|
Year
|
|
(a)
Reimbursement
of Additional
Tax Liability
Related to
Insurance
Premiums
|
|
|
(b)
401(k) Plan
Employer
Matching
Contribution
|
|
|
|
(c)
Opt-Out Bonus
|
|
|
Total
All Other
Compensation
|
|
|||||
Michael M.
Goldberg, M.D.
|
|
2016
|
|
$
|
436
|
|
|
$
|
—
|
|
|
|
$
|
—
|
|
|
$
|
436
|
|
|
|
|
2015
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
2014
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ricardo J.
Gonzalez
|
|
2016
|
|
$
|
836
|
|
|
$
|
2,516
|
|
|
|
$
|
—
|
|
|
$
|
3,352
|
|
|
|
|
2015
|
|
|
2,392
|
|
|
|
5,300
|
|
|
|
|
—
|
|
|
|
7,692
|
|
|
|
|
2014
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Frederick O. Cope,
Ph.D.
|
|
2016
|
|
$
|
1,435
|
|
|
$
|
5,300
|
|
|
|
$
|
—
|
|
|
$
|
6,735
|
|
|
|
|
2015
|
|
|
1,357
|
|
|
|
5,300
|
|
|
|
|
—
|
|
|
|
6,657
|
|
|
|
|
2014
|
|
|
973
|
|
|
|
5,200
|
|
|
|
|
—
|
|
|
|
6,173
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thomas
J. Klima
|
|
2016
|
|
$
|
2,326
|
|
|
$
|
—
|
|
|
|
$
|
—
|
|
|
$
|
2,326
|
|
|
|
|
2015
|
|
|
1,310
|
|
|
|
1,804
|
|
|
|
|
—
|
|
|
|
3,114
|
|
|
|
|
2014
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brent
L. Larson
|
|
2016
|
|
$
|
2,007
|
|
|
$
|
3,819
|
|
|
|
$
|
—
|
|
|
$
|
5,826
|
|
|
|
|
2015
|
|
|
2,392
|
|
|
|
5,300
|
|
|
|
|
—
|
|
|
|
7,692
|
|
|
|
|
2014
|
|
|
1,527
|
|
|
|
5,200
|
|
|
|
|
—
|
|
|
|
6,727
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jed A.
Latkin
|
|
2016
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
2015
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
2014
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
William J.
Regan
|
|
2016
|
|
$
|
106
|
|
|
$
|
5,036
|
|
|
|
$
|
1,000
|
|
|
$
|
6,142
|
|
|
|
|
2015
|
|
|
110
|
|
|
|
5,300
|
|
|
|
|
1,000
|
|
|
|
6,410
|
|
|
|
|
2014
|
|
|
80
|
|
|
|
5,200
|
|
|
|
|
1,000
|
|
|
|
6,280
|
|
|
|
Estimated Future
Payouts Under
Non-Equity Incentive
Plan Awards (a)
|
Estimated Future
Payouts Under
Equity Incentive
Plan Awards
|
All Other
Stock
Awards:
Number
of Shares
|
All Other
Option
Awards:
Number of
Securities
Underlying
|
Exercise
Price of
Option
|
Grant Date
Fair Value
of Stock
and Option
|
|
||
Named Executive Officer
|
Grant Date
|
Threshold
|
Maximum
|
Threshold
|
Maximum
|
of Stock
|
Options
|
Awards
|
Awards
|
|
Michael M.
Goldberg, M.D. (d)
|
N/A
|
$—
|
$83,013
|
—
|
—
|
—
|
—
|
$—
|
$—
|
(a)
|
|
|
|
|
|
|
|
|
|
|
|
Ricardo J.
Gonzalez
|
N/A
|
$—
|
$187,500
|
—
|
—
|
—
|
—
|
$—
|
$—
|
(a)
|
|
|
|
|
|
|
|
|
|
|
|
Frederick O. Cope,
Ph.D.
|
N/A
|
$—
|
$97,696
|
—
|
—
|
—
|
—
|
$—
|
$—
|
(a)
|
|
|
|
|
|
|
|
|
|
|
|
Thomas
J. Klima
|
N/A
|
$—
|
$94,500
|
—
|
—
|
—
|
—
|
—
|
$—
|
(a)
|
|
|
|
|
|
|
|
|
|
|
|
Brent
L. Larson
|
N/A
|
$—
|
$91,000
|
—
|
—
|
—
|
—
|
$—
|
$—
|
(a)
|
|
|
|
|
|
|
|
|
|
|
|
Jed A.
Latkin
|
4/20/2016
|
$—
|
$—
|
—
|
—
|
—
|
45,000
|
$1.50
|
$29,339
|
(b)
|
|
10/14/2016
|
$—
|
$—
|
—
|
—
|
—
|
20,000
|
$1.00
|
$10.653
|
(c)
|
|
|
|
|
|
|
|
|
|
|
|
William J.
Regan
|
N/A
|
$—
|
$87,500
|
—
|
—
|
—
|
—
|
$—
|
$—
|
(a)
|
|
Option Awards
|
Stock Awards
|
||||||||
|
Number of Securities Underlying Unexercised Options
(#)
|
|
|
|
|
|
Equity Incentive Plan Awards
|
|||
Named Executive
Officer
|
Exercisable
|
Unexercisable
|
Option
Exercise
Price
|
Option
Expiration
Date
|
Note
|
Number
of Shares of Stock that Have Not Vested
|
Market Value of Shares of Stock That Have Not Vested
|
Number of Unearned Shares
|
Market Value of Unearned Shares (v)
|
Note
|
Michael M. Goldberg, M.D.
|
—
|
5,000,000
|
$1.00
|
9/22/2026
|
(p)
|
|
|
28,000
|
$17,920
|
(r)
|
|
|
|
|
|
|
|
|
|
|
|
Ricardo J. Gonzalez (s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Frederick O. Cope, Ph.D.
|
50,000
|
—
|
$0.65
|
2/16/2019
|
(c)
|
|
|
50,000
|
$32,000
|
(q)
|
|
75,000
|
—
|
$1.10
|
10/30/2019
|
(d)
|
|
|
|
|
|
|
120,000
|
—
|
$1.90
|
12/21/2020
|
(e)
|
|
|
|
|
|
|
127,000
|
—
|
$3.28
|
2/17/2022
|
(g)
|
|
|
|
|
|
|
108,750
|
36,250
|
$3.08
|
2/15/2023
|
(h)
|
|
|
|
|
|
|
66,500
|
66,500
|
$1.77
|
1/28/2024
|
(i)
|
|
|
|
|
|
|
54,000
|
108,000
|
$1.65
|
3/26/2025
|
(l)
|
|
|
|
|
|
|
58,510
|
—
|
$0.98
|
2/25/2026
|
(m)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thomas J. Klima (t)
|
25,000
|
75,000
|
$1.89
|
1/1/2025
|
(k)
|
|
|
|
|
|
|
56,598
|
—
|
$0.98
|
2/25/2026
|
(m)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brent L. Larson (u)
|
50,000
|
—
|
$0.36
|
1/3/2018
|
(a)
|
|
|
|
|
|
|
25,000
|
—
|
$0.59
|
1/5/2019
|
(b)
|
|
|
|
|
|
|
75,000
|
—
|
$1.10
|
10/30/2019
|
(d)
|
|
|
|
|
|
|
95,000
|
—
|
$1.90
|
12/21/2020
|
(e)
|
|
|
|
|
|
|
88,000
|
—
|
$3.28
|
2/17/2022
|
(g)
|
|
|
|
|
|
|
106,500
|
—
|
$3.08
|
2/15/2023
|
(h)
|
|
|
|
|
|
|
62,000
|
—
|
$1.77
|
1/28/2024
|
(i)
|
|
|
|
|
|
|
50,334
|
—
|
$1.65
|
3/26/2025
|
(l)
|
|
|
|
|
|
|
54,501
|
—
|
0.98
|
2/25/2026
|
(m)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jed A. Latkin
|
45,000
|
—
|
$1.50
|
4/20/2026
|
(n)
|
|
|
|
|
|
|
20,000
|
—
|
$1.00
|
10/14/2026
|
(o)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
William J. Regan
|
20,000
|
—
|
$3.29
|
7/1/2021
|
(f)
|
|
|
|
|
|
|
84,000
|
—
|
$3.28
|
2/17/2022
|
(g)
|
|
|
|
|
|
|
75,000
|
25,000
|
$3.08
|
2/15/2023
|
(h)
|
|
|
|
|
|
|
42,500
|
42,500
|
$1.77
|
1/28/2024
|
(i)
|
|
|
|
|
|
|
12,500
|
12,500
|
$1.50
|
12/17/2024
|
(j)
|
|
|
|
|
|
|
55,000
|
110,000
|
$1.65
|
3/26/2025
|
(l)
|
|
|
|
|
|
|
52,405
|
—
|
$0.98
|
2/25/2026
|
(m)
|
|
|
|
|
|
|
Option Awards
|
Stock Awards
|
|
||
Named Executive Officer
|
Number of
Shares
Acquired
on Exercise
|
Value
Realized on
Exercise (a)
|
Number of
Shares
Acquired
on Vesting
|
Value
Realized
on
Vesting (a)
|
Note
|
Michael M.
Goldberg, M.D.
|
—
|
$—
|
22,000
|
$21,098
|
(b)
|
Ricardo J.
Gonzalez
|
—
|
$—
|
—
|
$—
|
|
Frederick O. Cope,
Ph.D.
|
—
|
$—
|
—
|
$—
|
|
Thomas
J. Klima
|
—
|
$—
|
—
|
$—
|
|
Brent
L. Larson
|
50,000
|
$23,000
|
—
|
$—
|
(c)
|
Jed A.
Latkin
|
—
|
$—
|
—
|
$—
|
|
William J.
Regan
|
—
|
$—
|
—
|
$—
|
|
Name
|
(a)
Fees
Earned or
Paid in
Cash or Stock
|
(b),(c)
Option
Awards
|
(d),(e)
Stock
Awards
|
All Other
Compensation
|
Total
Compensation
|
Anthony S.
Fiorino, M.D., Ph.D. (f)
|
$40,714
|
$—
|
$36,652
|
$—
|
$67,394
|
Brendan A. Ford
(g)
|
14,251
|
—
|
—
|
—
|
97,448
|
Michael M.
Goldberg, M.D. (h)
|
56,439
|
—
|
36,652
|
—
|
86,300
|
Mark
I. Greene, M.D., Ph.D., FRCP (f)
|
40,714
|
—
|
36,652
|
—
|
|
Anton
Gueth (i)
|
22,060
|
—
|
—
|
—
|
83,013
|
Y.
Michael Rice (j)
|
38,322
|
—
|
17,665
|
—
|
66,042
|
Eric
K. Rowinsky, M.D.
|
65,273
|
—
|
36,652
|
—
|
86,742
|
Gordon
A. Troup (k)
|
17,761
|
—
|
36,652
|
—
|
107,523
|
|
(1)
Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options, Warrants
and Rights
|
(2)
Weighted-Average
Exercise Price of
Outstanding
Options, Warrants
and Rights
|
(3)
Number of
Securities
Remaining Available
for Issuance Under
Equity
Compensation Plans
(Excluding
Securities Reflected
in Column (1))
|
Equity compensation plans approved by
security holders (a)
|
3,380,615
|
$2.00
|
3,250,817
|
|
|
|
|
Equity compensation plans not approved by
security holders (b)
|
—
|
—
|
—
|
|
|
|
|
Total
|
3,380,615
|
$2.00
|
3,250,817
|
Beneficial Owner
|
|
Number of Shares
Beneficially Owned (*)
|
|
|
|
Percent
of Class (**)
|
|
|
||
Frederick O. Cope,
Ph.D.
|
|
|
963,853
|
|
(a)
|
|
|
—
|
|
(n)
|
Anthony S.
Fiorino, M.D., Ph.D.
|
|
|
28,000
|
|
(b)
|
|
|
—
|
|
(n)
|
Michael M.
Goldberg, M.D.
|
|
|
5,815,002
|
|
(c)
|
|
|
3.6
|
%
|
|
Ricardo J.
Gonzalez
|
|
|
—
|
|
(d)
|
|
|
—
|
|
(n)
|
Mark
I. Greene, M.D., Ph.D., FRCP
|
|
|
57,244
|
|
(e)
|
|
|
—
|
|
(n)
|
Thomas
J. Klima
|
|
|
158,533
|
|
(f)
|
|
|
—
|
|
(n)
|
Brent
L. Larson
|
|
|
979,619
|
|
(g)
|
|
|
—
|
|
(n)
|
Jed A.
Latkin
|
|
|
65,000
|
|
(h)
|
|
|
|
|
(n)
|
William J.
Regan
|
|
|
565,867
|
|
(i)
|
|
|
|
|
(n)
|
Y.
Michael Rice
|
|
|
—
|
|
(j)
|
|
|
—
|
|
(n)
|
Eric
K. Rowinsky, M.D.
|
|
|
298,210
|
|
(k)
|
|
|
—
|
|
(n)
|
All
directors and executive officers as a group (9
persons)
|
|
|
7,951,709
|
|
(l)(o)
|
|
|
4.9
|
%
|
|
Platinum-Montaur
Life Sciences, LLC
|
|
|
16,173,644
|
|
(m)
|
|
|
9.9
|
%
|
|
Report of Independent Registered Public
Accounting Firm –
Marcum LLP
|
F-2
|
|
|
Report of Independent Registered Public
Accounting Firm –
BDO USA, LLP
|
F-4
|
|
|
Consolidated Balance Sheets as of December
31, 2016 and 2015
|
F-6
|
|
|
Consolidated Statements of Operations for the years ended December
31, 2016, 2015 and 2014
|
F-7
|
|
|
Consolidated Statements of Stockholders’ Deficit for the
years ended December 31, 2016, 2015 and 2014
|
F-7
|
|
|
Consolidated Statements of Cash Flows for the years ended December
31, 2016, 2015 and 2014
|
F-9
|
|
|
Notes to the Consolidated
Financial Statements
|
F-11
|
Exhibit
Number
|
|
Exhibit Description
|
|
|
|
3.1
|
|
Amended and
Restated Certificate of Incorporation of Navidea
Biopharmaceuticals, Inc., as corrected February 18, 1994, and
amended June 27, 1994, July 25, 1995, June 3, 1996, March 17, 1999,
May 9, 2000, June 13, 2003, July 29, 2004, June 22, 2005, November
20, 2006, December 26, 2007, April 30, 2009, July 27, 2009, August
2, 2010, January 5, 2012, June 26, 2013 and August 18,
2016).*
|
|
|
|
3.2
|
|
Amended and
Restated By-Laws dated July 21, 1993, as amended July 18, 1995, May
30, 1996, July 26, 2007, and November 7, 2013 (filed as Exhibit 3.2
to the Company’s Quarterly Report on Form 10-Q filed November
12, 2013, and incorporated herein by reference).
|
|
|
|
4.1
|
|
Amended and
Restated Certificate of Designations, Voting Powers, Preferences,
Limitations, Restrictions, and Relative Rights of Series B
Cumulative Convertible Preferred Stock (incorporated by reference
to Exhibit 4.1 to the Company’s Current Report on Form 8-K
filed June 26, 2013).
|
|
|
|
10.1
|
|
Supply
and Distribution Agreement, dated November 15, 2007, between the
Company and Cardinal Health 414, LLC (portions of this Exhibit have
been omitted pursuant to a request for confidential treatment and
have been filed separately with the Commission) (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed November 21, 2007).
|
|
|
|
10.2
|
|
Manufacture and
Supply Agreement, dated November 30, 2009, between the Company and
Reliable Biopharmaceutical Corporation (portions of this Exhibit
have been omitted pursuant to a request for confidential treatment
and have been filed separately with the Commission) (incorporated
by reference to Exhibit 10.1 to the Company’s June 30, 2010
Form 10-Q).
|
|
|
|
10.3
|
|
Asset
Purchase Agreement, dated May 24, 2011, between Devicor Medical
Products, Inc. and the Company (portions of this Exhibit have been
omitted pursuant to a request for confidential treatment and have
been filed separately with the SEC) (incorporated by reference to
Exhibit 10.1 to the Company’s Current Report on Form 8-K/A
filed July 19, 2011).
|
|
|
|
10.4
|
|
License Agreement,
dated December 9, 2011, between AstraZeneca AB and the Company
(portions of this Exhibit have been omitted pursuant to a request
for confidential treatment and have been filed separately with the
United States Securities and Exchange Commission) (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K/A filed April 11, 2012).
|
|
|
|
10.5
|
|
Loan
Agreement, dated July 25, 2012, between the Company and
Platinum-Montaur Life Sciences LLC (incorporated by reference to
Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed July 31, 2012).
|
|
|
|
10.6
|
|
Promissory Note,
dated July 25, 2012, made by Navidea Biopharmaceuticals, Inc. in
favor of Platinum-Montaur Life Sciences LLC (incorporated by
reference to Exhibit 10.2 to the Company’s Current Report on
Form 8-K filed July 31, 2012).
|
|
|
|
10.7
|
|
Form
of Employment Agreement between the Company and each of Dr.
Frederick O. Cope and Mr. Brent L. Larson. This agreement is one of
two substantially identical employment agreements and is
accompanied by a schedule which identifies material details in
which each individual agreement differs from the form filed
herewith (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed January 7, 2013).
^
|
|
|
|
10.8
|
|
Schedule
identifying material differences between the employment agreements
incorporated by reference as Exhibit 10.4 to this Annual Report on
Form 10-K (incorporated by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K filed January 7, 2013).
^
|
|
|
|
10.9
|
|
Amendment to Loan
Agreement, dated June 25, 2013, between Navidea Biopharmaceuticals,
Inc. and Platinum-Montaur Life Sciences LLC (incorporated by
reference to Exhibit 10.4 to the Company’s Current Report on
Form 8-K filed June 28, 2013).
|
|
|
|
10.10
|
|
Amended and
Restated Promissory Note, dated June 25, 2013, made by Navidea
Biopharmaceuticals, Inc. in favor of Platinum-Montaur Life Sciences
LLC (incorporated by reference to Exhibit 10.6 to the
Company’s Current Report on Form 8-K filed June 28,
2013).
|
|
|
|
10.11
|
|
Series
HH Warrant to purchase common stock of Navidea Biopharmaceuticals,
Inc. issued to GE Capital Equity Investments, Inc., dated June 25,
2013 (incorporated by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K filed June 28,
2013).
|
|
|
|
10.12
|
|
Series
HH Warrant to purchase common stock of Navidea Biopharmaceuticals,
Inc. issued to MidCap Financial SBIC, LP, dated June 25, 2013
(incorporated by reference to Exhibit 10.3 to the Company’s
Current Report on Form 8-K filed June 28, 2013).
|
|
|
|
10.13
|
|
Office
Lease, dated August 29, 2013, by and between Navidea
Biopharmaceuticals, Inc. and BRE/COH OH LLC (portions of this
Exhibit have been omitted pursuant to a request for confidential
treatment and have been filed separately with the United States
Securities and Exchange Commission) (incorporated by reference to
Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed September 5, 2013).
|
|
|
|
10.14
|
|
Manufacturing
Services Agreement, dated September 9, 2013, by and between Navidea
Biopharmaceuticals, Inc. and OSO BioPharmaceuticals Manufacturing,
LLC (portions of this Exhibit have been omitted pursuant to a
request for confidential treatment and have been filed separately
with the United States Securities and Exchange Commission)
(incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed September 12, 2013).
|
|
|
|
10.15
|
|
Director
Agreement, dated November 13, 2013, by and between Navidea
Biopharmaceuticals, Inc. and Michael M. Goldberg, M.D.
(incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed November 19, 2013).
|
|
|
|
10.16
|
|
Second
Amendment to Loan Agreement, dated March 4, 2014, between Navidea
Biopharmaceuticals, Inc. and Platinum-Montaur Life Sciences LLC
(incorporated by reference to Exhibit 10.3 to the Company’s
Current Report on Form 8-K filed March 7, 2014).
|
|
|
|
10.17
|
|
Second
Amended and Restated Promissory Note, dated March 4, 2014, made by
Navidea Biopharmaceuticals, Inc. in favor of Platinum-Montaur Life
Sciences LLC (incorporated by reference to Exhibit 10.4 to the
Company’s Current Report on Form 8-K filed March 7,
2014).
|
|
|
|
10.18
|
|
Form
of Series KK Warrants to purchase common stock of Navidea
Biopharmaceuticals, Inc. issued to Oxford Finance LLC on March 4,
2014 (incorporated by reference to Exhibit 10.5 to the
Company’s Current Report on Form 8-K filed March 7,
2014).
|
|
|
|
10.19
|
|
Amended and
Restated License Agreement, dated July 14, 2014, between the
Company and the Regents of the University of California (portions
of this Exhibit have been omitted pursuant to a request for
confidential treatment and have been filed separately with the
United States Securities and Exchange Commission) (incorporated by
reference to Exhibit 10.1 to the Company’s Quarterly Report
on Form 10-Q filed August 11, 2014).
|
|
|
|
10.20
|
|
Termination of
License Agreement, dated July 14, 2014, between the Company and the
Regents of the University of California (incorporated by reference
to Exhibit 10.2 to the Company’s Quarterly Report on Form
10-Q filed August 11, 2014).
|
|
|
|
10.21
|
|
License Agreement,
dated July 14, 2014, between the Company and the Regents of the
University of California (portions of this Exhibit have been
omitted pursuant to a request for confidential treatment and have
been filed separately with the United States Securities and
Exchange Commission) (incorporated by reference to Exhibit 10.3 to
the Company’s Quarterly Report on Form 10-Q filed August 11,
2014).
|
|
|
|
10.22
|
|
Navidea
Biopharmaceuticals, Inc. 2014 Stock Incentive Plan, adopted July
17, 2014 and amended March 3, 2015 (incorporated by reference to
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q
filed May 11, 2015). ^
|
|
|
|
10.23
|
|
Form
of Stock Option Agreement under the Navidea Biopharmaceuticals,
Inc. 2014 Stock Incentive Plan (incorporated by reference to
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q
filed November 10, 2014). ^
|
|
|
|
10.24
|
|
Form
of Restricted Stock Award and Agreement under the Navidea
Biopharmaceuticals, Inc. 2014 Stock Incentive Plan (incorporated by
reference to Exhibit 10.2 to the Company’s Quarterly Report
on Form 10-Q filed November 10, 2014). ^
|
|
|
|
10.25
|
|
Employment
Agreement, dated October 13, 2014, between Navidea
Biopharmaceuticals, Inc. and Ricardo J. Gonzalez (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed October 15, 2014). ^
|
|
|
|
10.26
|
|
Stock
Option Agreement, dated October 13, 2014, between Navidea
Biopharmaceuticals, Inc. and Ricardo J. Gonzalez (incorporated by
reference to Exhibit 10.2 to the Company’s Current Report on
Form 8-K filed October 15, 2014). ^
|
|
|
|
10.27
|
|
Securities
Exchange Agreement, dated November 12, 2014, by and between Navidea
Biopharmaceuticals, Inc. and Platinum Partners Value Arbitrage
Fund, L.P. (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed November 13,
2014).
|
|
|
|
10.28
|
|
Employment
Agreement between the Company and Thomas J. Klima, dated January 1,
2015 (incorporated by reference to Exhibit 10.1 to the
Company’s Quarterly Report on Form 10-Q filed August 10,
2015).^
|
|
|
|
10.29
|
|
Employment
Agreement between the Company and Michael Tomblyn, M.D., dated
January 1, 2015 (incorporated by reference to Exhibit 10.2 to the
Company’s Quarterly Report on Form 10-Q filed August 10,
2015).^
|
|
|
|
10.30
|
|
Securities
Exchange Agreement dated as of March 11, 2015 among Macrophage
Therapeutics, Inc., Platinum-Montaur Life Sciences, LLC and Michael
Goldberg, M.D. (incorporated by reference to Exhibit 10.2 to the
Company’s Quarterly Report on Form 10-Q filed May 11,
2015).
|
|
|
|
10.31
|
|
Navidea
Biopharmaceuticals, Inc. 2015 Cash Bonus Plan adopted March 26,
2015 (incorporated by reference to the Company’s Current
Report on Form 8-K filed April 1, 2015). ^
|
|
|
|
10.32
|
|
Termination
Agreement, dated April 21, 2015, by and between Navidea
Biopharmaceuticals, Inc. and Alseres Pharmaceuticals, Inc.
(portions of this Exhibit have been omitted pursuant to a request
for confidential treatment and have been filed separately with the
United States Securities and Exchange Commission) (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed April 27, 2015).
|
|
|
|
10.33
|
|
Term
Loan Agreement, dated as of May 8, 2015, by and among Navidea
Biopharmaceuticals, Inc., as borrower, Macrophage Therapeutics,
Inc. as guarantor, and Capital Royalty Partners II L.P., Capital
Royalty Partners II – Parallel Fund “A” L.P. and
Parallel Investment Opportunities Partners II L.P., as lenders
(incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K/A filed October 9, 2015).
|
|
|
|
10.34
|
|
Security
Agreement, dated as of May 15, 2015 among Navidea
Biopharmaceuticals, Inc., as borrower, Macrophage Therapeutics,
Inc. as guarantor, and Capital Royalty Partners II L.P., Capital
Royalty Partners II – Parallel Fund “A” L.P. and
Parallel Investment Opportunities Partners II L.P., as lenders, and
Capital Royalty Partners II L.P., as control agent (incorporated by
reference to Exhibit 10.2 to the Company’s Current Report on
Form 8-K filed May 15, 2015).
|
|
|
|
10.35
|
|
Subordination
Agreement, dated as of May 8, 2015, among Platinum-Montaur Life
Sciences, LLC, as subordinated creditor, Capital Royalty Partners
II L.P., Capital Royalty Partners II – Parallel Fund
“A” L.P. and Parallel Investment Opportunities Partners
II L.P., as senior creditors, and Capital Royalty Partners II L.P.,
as senior creditor agent, and consented to by Navidea
Biopharmaceuticals, Inc. as borrower (incorporated by reference to
Exhibit 10.3 to the Company’s Current Report on Form 8-K
filed May 15, 2015).
|
|
|
|
10.36
|
|
Third
Amendment to Loan Agreement, dated as of May 8, 2015, by and
between Navidea Biopharmaceuticals, Inc, as borrower, and
Platinum-Montaur Life Sciences, LLC, as lender (incorporated by
reference to Exhibit 10.4 to the Company’s Current Report on
Form 8-K filed May 15, 2015).
|
|
|
|
10.37
|
|
Third
Amended and Restated Promissory Note, dated May 8, 2015, made by
Navidea Biopharmaceuticals, Inc. in favor of Platinum-Montaur Life
Sciences LLC (incorporated by reference to Exhibit 10.5 to the
Company’s Current Report on Form 8-K filed May 15,
2015).
|
|
|
|
10.38
|
|
Securities
Exchange Agreement, dated as of August 20, 2015, among the Company,
Montsant Partners LLC and Platinum Partners Value Arbitrage Fund,
L.P. (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed August 26,
2015).
|
|
|
|
10.39
|
|
Form
of Series LL Warrant issued to Montsant Partners LLC and Platinum
Partners Value Arbitrage Fund, L.P. (incorporated by reference to
Exhibit 10.2 to the Company’s Current Report on Form 8-K
filed August 26, 2015).
|
|
|
|
10.40
|
|
Amendment 1 to
Term Loan Agreement by and among Navidea Biopharmaceuticals, Inc.,
as borrower, and Capital Royalty Partners II L.P., Capital Royalty
Partners II – Parallel Fund “A” L.P. and Parallel
Investment Opportunities Partners II L.P., as lenders, dated as of
December 23, 2015 (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed January 11,
2016).
|
|
|
|
10.41
|
|
Agreement dated as
of March 14, 2016 by and among the Company, Platinum Partners Value
Arbitrage Fund L.P., Platinum Partners Liquid Opportunity Master
Fund L.P., Platinum-Montaur Life Sciences, LLC, Platinum Management
(NY) LLC, Platinum Liquid Opportunity Management (NY) LLC and Mark
Nordlicht (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed March 18,
2016).
|
|
|
|
10.42
|
|
Director
Agreement, dated March 15, 2016, by and between Navidea
Biopharmaceuticals, Inc. and Mark I. Greene, M.D., Ph.D., FRCP
(incorporated by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K filed March 29, 2016).
|
|
|
|
10.43
|
|
Director
Agreement, dated March 17, 2016, by and between Navidea
Biopharmaceuticals, Inc. and Anthony S. Fiorino, M.D., Ph.D.
(incorporated by reference to Exhibit 10.3 to the Company’s
Current Report on Form 8-K filed March 29, 2016).
|
|
|
|
10.44
|
|
Form
of Director Agreement (incorporated by reference to Exhibit 10.1 to
the Company’s Current Report on Form 8-K filed May 10,
2016).
|
|
|
|
10.45
|
|
Employment
Agreement, dated May 9, 2016 and effective as of April 21, 2016,
between Navidea Biopharmaceuticals, Inc. and Jed A. Latkin
(incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K/A filed May 10, 2016). ^
|
|
|
|
10.46
|
|
Settlement
Agreement, dated June 16, 2016, by and among Navidea
Biopharmaceuticals, Inc., Platinum Partners Value Arbitrage Fund,
L.P. and Platinum-Montaur Life Sciences, LLC, Cody Christopherson,
and Hunter & Kmiec (incorporated by reference to Exhibit 10.1
to the Company?s Current Report on Form 8-K filed June 29,
2016).
|
|
|
|
10.47
|
|
Employment
Agreement, dated September 22, 2016, between Navidea
Biopharmaceuticals, Inc. and Michael M. Goldberg, M.D.
(incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed September 27, 2016).
^
|
|
|
|
10.48
|
|
Asset
Purchase Agreement, dated November 23, 2016, between Navidea
Biopharmaceuticals, Inc. and Cardinal Health 414, LLC (incorporated
by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed November 30, 2016).
|
|
|
|
10.49
|
|
Global
Settlement Agreement dated March 3, 2017 by and among Navidea
Biopharmaceuticals, Inc., Cardinal Health 414, LLC, Macrophage
Therapeutics, Inc., Capital Royalty Partners II L.P., Capital
Royalty Partners II (Cayman), L.P., Capital Royalty Partners II
– Parallel Fund “A” L.P., Parallel Investment
Opportunities Partners II L.P. and Capital Royalty Partners II
– Parallel Fund “B” (Cayman) L.P. (incorporated
by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed March 8, 2017).
|
|
|
|
10.50
|
|
License-Back
Agreement, dated March 3, 2017, between Navidea Biopharmaceuticals,
Inc. and Cardinal Health 414, LLC (incorporated by reference to
Exhibit 10.3 to the Company’s Current Report on Form 8-K
filed March 8, 2017).
|
|
|
|
10.51
|
|
Warrant, dated
March 3, 2017, issued to Cardinal Health 414, LLC (incorporated by
reference to Exhibit 10.4 to the Company’s Current Report on
Form 8-K filed March 8, 2017).
|
|
|
|
10.52
|
|
Warrant, dated
March 3, 2017, issued to The Regents of the University of
California (San Diego) (incorporated by reference to Exhibit 10.5
to the Company’s Current Report on Form 8-K filed March 8,
2017).
|
|
|
|
10.53
|
|
Amended and
Restated License Agreement, dated March 3, 2017, between Navidea
Biopharmaceuticals, Inc. and The Regents of the University of
California (San Diego) (portions of this Exhibit have been omitted
pursuant to a request for confidential treatment and have been
filed separately with the Securities and Exchange Commission)
(incorporated by reference to Exhibit 10.6 to the Company’s
Current Report on Form 8-K filed March 8, 2017).
|
|
|
|
21.1
|
|
Subsidiaries of
the registrant.*
|
|
|
|
23.1
|
|
Consent of Marcum
LLP.*
|
|
|
|
23.2
|
|
Consent of BDO
USA, LLP.*
|
|
|
|
24.1
|
|
Power
of Attorney.*
|
|
|
|
31.1
|
|
Certification of
Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
|
|
|
31.2
|
|
Certification of
Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
|
|
|
32.1
|
|
Certification of
Chief Executive Officer of Periodic Financial Reports pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section
1350.*
|
|
|
|
32.2
|
|
Certification of
Chief Financial Officer of Periodic Financial Reports pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section
1350.*
|
|
|
|
101.INS
|
|
XBRL
Instance Document *
|
|
|
|
101.SCH
|
|
XBRL
Taxonomy Extension Schema Document *
|
|
|
|
101.CAL
|
|
XBRL
Taxonomy Extension Calculation Linkbase Document *
|
|
|
|
101.DEF
|
|
XBRL
Taxonomy Extension Definition Linkbase Document *
|
|
|
|
101.LAB
|
|
XBRL
Taxonomy Extension Label Linkbase Document *
|
|
|
|
101.PRE
|
|
XBRL
Taxonomy Extension Presentation Linkbase Document *
|
Dated:
March 31, 2017
|
|
|
|
NAVIDEA BIOPHARMACEUTICALS, INC.
|
|
|
(the
Company)
|
|
|
|
|
|
By:
|
/s/
Michael M. Goldberg
|
|
|
Michael M.
Goldberg, M.D.
|
|
|
President and
Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/
Michael M. Goldberg
|
|
Director,
President and
Chief
Executive Officer
(principal
executive officer)
|
|
March
31, 2017
|
Michael M.
Goldberg, M.D.
|
|
|
|
|
|
|
|
|
|
/s/
Jed A. Latkin*
|
|
Interim Chief
Operating Officer and
Chief
Financial Officer
(principal
financial officer and
principal
accounting officer)
|
|
March
31, 2017
|
Jed A.
Latkin
|
|
|
|
|
|
|
|
|
|
/s/
Eric K. Rowinsky*
|
|
Chairman,
Director
|
|
March
31, 2017
|
Eric
K. Rowinsky, M.D.
|
|
|
|
|
|
|
|
|
|
/s/
Anthony S. Fiorino*
|
|
Director
|
|
March
31, 2017
|
Anthony S.
Fiorino, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/
Mark I. Greene*
|
|
Director
|
|
March
31, 2017
|
Mark
I. Greene, M.D., Ph.D., FRCP
|
|
|
|
|
|
|
|
|
|
/s/ Y.
Michael Rice*
|
|
Director
|
|
March
31, 2017
|
Y.
Michael Rice
|
|
|
|
|
*By:
|
/s/
Michael M. Goldberg
|
|
|
Michael M.
Goldberg, M.D., Attorney-in-fact
|
|
Consolidated Financial Statements of Navidea Biopharmaceuticals,
Inc.
|
|
|
|
Report of Independent Registered Public
Accounting Firm –
Marcum LLP
|
F-2
|
|
|
Report of Independent Registered Public
Accounting Firm –
BDO USA, LLP
|
F-4
|
|
|
Consolidated Balance Sheets as
of December 31, 2016 and 2015
|
F-6
|
|
|
Consolidated Statements of Operations for the years ended December
31, 2016, 2015 and 2014
|
F-7
|
|
|
Consolidated Statements of
Stockholders’ Deficit for the years ended December 31, 2016,
2015 and 2014
|
F-7
|
|
|
Consolidated Statements of Cash Flows for
the years ended December 31, 2016, 2015 and 2014
|
F-9
|
|
|
Notes to the Consolidated
Financial Statements
|
F-11
|
ASSETS
|
December 31,
2016
|
December 31,
2015
|
Current assets:
|
|
|
Cash
|
$1,539,325
|
$7,166,260
|
Restricted cash
|
5,001,253
|
—
|
Accounts and other receivables
|
1,802,010
|
3,703,186
|
Inventory, net
|
1,470,826
|
652,906
|
Prepaid expenses and other
|
1,012,855
|
1,054,822
|
Total current assets
|
10,826,269
|
12,577,174
|
Property and equipment
|
3,584,628
|
3,871,035
|
Less accumulated depreciation and amortization
|
2,333,070
|
1,943,427
|
|
1,251,558
|
1,927,608
|
Patents and trademarks
|
202,194
|
233,596
|
Less accumulated amortization
|
21,227
|
47,438
|
|
180,967
|
186,158
|
Other assets
|
202,882
|
273,573
|
Total assets
|
$12,461,676
|
$14,964,513
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
|
Current liabilities:
|
|
|
Accounts payable
|
$7,123,323
|
$1,767,523
|
Accrued liabilities and other
|
8,465,515
|
3,038,713
|
Deferred revenue, current
|
2,315,037
|
1,044,281
|
Notes payable, current
|
51,957,913
|
333,333
|
Total current liabilities
|
69,861,788
|
6,183,850
|
Deferred revenue
|
26,061
|
192,728
|
Notes payable, net of current portion and discounts of $0 and
$2,033,506, respectively
|
9,641,179
|
60,746,002
|
Other liabilities
|
598,861
|
1,677,633
|
Total liabilities
|
80,127,889
|
68,800,213
|
Commitments and contingencies (Note 13)
|
|
|
Stockholders’ deficit:
|
|
|
Preferred stock; $.001 par value; 5,000,000 shares authorized; no
shares
issued or outstanding at December 31, 2016 and
2015, respectively
|
—
|
—
|
Common stock; $.001 par value; 300,000,000 shares authorized;
155,762,729
and 155,649,665 shares issued and outstanding at
December 31, 2016 and
2015, respectively
|
155,763
|
155,650
|
Additional paid-in capital
|
326,564,148
|
326,085,743
|
Accumulated deficit
|
(394,855,034)
|
(380,546,651)
|
Total Navidea stockholders' deficit
|
(68,135,123)
|
(54,305,258)
|
Non-controlling interest
|
468,910
|
469,558
|
Total stockholders’ deficit
|
(67,666,213)
|
(53,835,700)
|
Total liabilities and stockholders’ deficit
|
$12,461,676
|
$14,964,513
|
|
Years Ended December 31,
|
||
|
2016
|
2015
|
2014
|
Revenue:
|
|
|
|
Lymphoseek sales revenue
|
$17,037,098
|
$10,254,352
|
$4,233,953
|
Lymphoseek license revenue
|
1,795,625
|
1,133,333
|
300,000
|
Grant and other revenue
|
3,136,983
|
1,861,622
|
1,740,896
|
Total revenue
|
21,969,706
|
13,249,307
|
6,274,849
|
Cost of goods sold
|
2,297,040
|
1,754,763
|
1,586,145
|
Gross profit
|
19,672,666
|
11,494,544
|
4,688,704
|
Operating expenses:
|
|
|
|
Research and development
|
8,882,576
|
12,787,733
|
16,779,589
|
Selling, general and administrative
|
13,013,565
|
17,257,329
|
15,542,071
|
Total operating expenses
|
21,896,141
|
30,045,062
|
32,321,660
|
Loss from operations
|
(2,223,475)
|
(18,550,518)
|
(27,632,956)
|
Other income (expense):
|
|
|
|
Interest expense, net
|
(14,861,270)
|
(6,873,736)
|
(3,690,068)
|
Equity in loss of R-NAV, LLC
|
(15,159)
|
(305,253)
|
(523,809)
|
Loss on disposal of investment in R-NAV, LLC
|
(39,732)
|
—
|
—
|
Change in fair value of financial instruments
|
2,858,524
|
(614,782)
|
(1,342,389)
|
Loss on extinguishment of debt
|
—
|
(2,440,714)
|
(2,610,196)
|
Other, net
|
(27,919)
|
26,808
|
72,749
|
Total other expense, net
|
(12,085,556)
|
(10,207,677)
|
(8,093,713)
|
Loss before income taxes
|
(14,309,031)
|
(28,758,195)
|
(35,726,669)
|
Benefit from income taxes
|
—
|
436,051
|
—
|
Loss from continuing operations
|
(14,309,031)
|
(28,322,144)
|
(35,726,669)
|
Income from discontinued operations, net of tax effect
|
—
|
758,609
|
—
|
Net loss
|
(14,309,031)
|
(27,563,535)
|
(35,726,669)
|
Less loss attributable to noncontrolling interest
|
(648)
|
(855)
|
—
|
Deemed dividend on beneficial conversion feature of MT Preferred
Stock
|
—
|
(46,000)
|
—
|
Net loss attributable to common stockholders
|
$(14,308,383)
|
$(27,608,680)
|
$(35,726,669)
|
(Loss) income per common share (basic and diluted):
|
|
|
|
Continuing operations
|
$(0.09)
|
$(0.19)
|
$(0.24)
|
Discontinued operations
|
$—
|
$0.01
|
$—
|
Attributable to common stockholders
|
$(0.09)
|
$(0.18)
|
$(0.24)
|
Weighted average shares outstanding (basic and
diluted)
|
155,422,384
|
151,180,222
|
148,748,396
|
|
Preferred Stock
|
Common Stock
|
Additional
Paid-In
|
Accumulated
|
Non-
controlling
|
Total
Stockholders'
|
||
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Interest
|
Deficit
|
Balance, January 1, 2014
|
7,565
|
$8
|
135,919,423
|
$135,919
|
$313,111,788
|
$(317,257,302)
|
$—
|
$(4,009,587)
|
Issued stock upon exercise of
stock options, net
|
—
|
—
|
299,360
|
300
|
(51,669)
|
—
|
—
|
(51,369)
|
Issued restricted stock
|
—
|
—
|
380,250
|
380
|
—
|
—
|
—
|
380
|
Canceled stock to pay employee
tax obligations
|
—
|
—
|
(6,582)
|
(6)
|
(8,813)
|
—
|
—
|
(8,819)
|
Canceled forfeited restricted stock
|
—
|
—
|
(300,000)
|
(300)
|
—
|
—
|
—
|
(300)
|
Issued stock to 401(k) plan
|
—
|
—
|
36,455
|
36
|
100,007
|
—
|
—
|
100,043
|
Conversion of Series B Preferred
Stock to common stock, net
|
(3,046)
|
(4)
|
9,960,420
|
9,960
|
(9,956)
|
—
|
—
|
—
|
Issued warrants in connection with
debt issuance
|
—
|
—
|
—
|
—
|
464,991
|
—
|
—
|
464,991
|
Issued stock upon exchange of warrants
|
—
|
—
|
3,843,223
|
3,843
|
7,682,930
|
—
|
—
|
7,686,773
|
Issued stock in payment of
Board retainers
|
—
|
—
|
67,710
|
68
|
89,307
|
—
|
—
|
89,375
|
Recovery of shareholder short
swing profits
|
—
|
—
|
—
|
—
|
17,554
|
—
|
—
|
17,554
|
Stock compensation expense
|
—
|
—
|
—
|
—
|
1,634,162
|
—
|
—
|
1,634,162
|
Net loss
|
—
|
—
|
—
|
—
|
—
|
(35,726,669)
|
—
|
(35,726,669)
|
Balance, December 31, 2014
|
4,519
|
4
|
150,200,259
|
150,200
|
323,030,301
|
(352,983,971)
|
—
|
(29,803,466)
|
Issued stock upon exercise of
stock options, net
|
—
|
—
|
124,238
|
124
|
54,206
|
—
|
—
|
54,330
|
Issued restricted stock
|
—
|
—
|
354,000
|
354
|
—
|
—
|
—
|
354
|
Canceled forfeited restricted stock
|
—
|
—
|
(158,000)
|
(158)
|
158
|
—
|
—
|
—
|
Canceled stock to pay employee
tax obligations
|
—
|
—
|
(7,645)
|
(7)
|
(12,607)
|
—
|
—
|
(12,614)
|
Issued stock in payment of
Board retainers
|
—
|
—
|
90,977
|
91
|
172,878
|
—
|
—
|
172,969
|
Issued stock to 401(k) plan
|
—
|
—
|
68,157
|
68
|
117,031
|
—
|
—
|
117,099
|
Exchanged Series B Preferred
Stock for warrants
|
(4,519)
|
(4)
|
—
|
—
|
4
|
—
|
—
|
—
|
Extension of warrant expiration date
|
—
|
—
|
—
|
—
|
149,615
|
—
|
—
|
149,615
|
Issued warrants in connection with
advisory services agreement
|
—
|
—
|
—
|
—
|
256,450
|
—
|
—
|
256,450
|
Issued stock upon exercise of warrants
|
—
|
—
|
4,977,679
|
4,978
|
(4,978)
|
—
|
—
|
—
|
Stock compensation expense
|
—
|
—
|
—
|
—
|
2,368,685
|
—
|
—
|
2,368,685
|
Net loss
|
—
|
—
|
—
|
—
|
—
|
(27,562,680)
|
(855)
|
(27,563,535)
|
Issuance of MT Preferred Stock,
net of deemed dividend
|
—
|
—
|
—
|
—
|
(46,000)
|
—
|
470,413
|
424,413
|
Balance, December 31, 2015
|
—
|
—
|
155,649,665
|
155,650
|
326,085,743
|
(380,546,651)
|
469,558
|
(53,835,700)
|
Issued restricted stock
|
—
|
—
|
168,000
|
168
|
—
|
—
|
—
|
168
|
Canceled forfeited restricted stock
|
—
|
—
|
(256,000)
|
(256)
|
228
|
—
|
—
|
(28)
|
Issued stock in payment of
Board retainers
|
—
|
—
|
84,062
|
84
|
66,455
|
—
|
—
|
66,539
|
Issued stock to 401(k) Plan
|
—
|
—
|
67,002
|
67
|
120,733
|
—
|
—
|
120,800
|
Issued stock upon exercise of
stock options, net
|
—
|
—
|
50,000
|
50
|
13,450
|
—
|
—
|
13,500
|
Stock compensation expense
|
—
|
—
|
—
|
—
|
277,539
|
—
|
—
|
277,539
|
Net loss
|
—
|
—
|
—
|
—
|
—
|
(14,308,383)
|
(648)
|
(14,309,031)
|
Balance, December 31, 2016
|
—
|
$—
|
155,762,729
|
$155,763
|
$326,564,148
|
$(394,855,034)
|
$468,910
|
$(67,666,213)
|
|
Year Ended December 31,
|
||
|
2016
|
2015
|
2014
|
Cash flows from operating activities:
|
|
|
|
Net loss
|
$(14,309,031)
|
$(27,563,535)
|
$(35,726,669)
|
Adjustments to reconcile net loss to net cash provided by (used
in)
operating activities:
|
|
|
|
Depreciation and amortization of property and
equipment
|
496,178
|
562,468
|
487,906
|
Amortization of patents and trademarks
|
5,191
|
8,951
|
12,277
|
Loss on disposal and abandonment of assets
|
136,719
|
33,184
|
31,794
|
Gain on forgiveness of accounts payable
|
(85,355)
|
—
|
—
|
Change in inventory reserve
|
43,354
|
143,493
|
539,027
|
Amortization of debt discount and issuance costs
|
77,964
|
492,963
|
844,250
|
Debt discount and issuance costs written off
|
1,955,541
|
—
|
—
|
Prepayment premium and debt collection fees related to long term
debt
|
2,923,271
|
—
|
—
|
Compounded interest on long term debt
|
1,561,568
|
2,048,960
|
—
|
Stock compensation expense
|
277,539
|
2,368,685
|
1,634,162
|
Equity in loss of R-NAV, LLC
|
15,159
|
305,253
|
523,809
|
Loss on disposal of investment in R-NAV, LLC
|
39,732
|
—
|
—
|
Change in fair value of financial instruments
|
(2,858,524)
|
614,782
|
1,342,389
|
Loss on extinguishment of debt
|
—
|
2,440,714
|
2,610,196
|
Issued stock to 401(k) plan for employer matching
contributions
|
120,800
|
117,099
|
100,043
|
Extension of warrant expiration date
|
—
|
149,615
|
—
|
Issued warrants in connection with advisory services
agreement
|
—
|
256,450
|
—
|
Value of restricted stock issued to directors
|
66,539
|
172,969
|
89,375
|
Other
|
(15,159)
|
(63,677)
|
(38,657)
|
Changes in operating assets and liabilities:
|
|
|
|
Accounts and other receivables
|
1,882,855
|
(2,808,696)
|
334,082
|
Inventory
|
(861,274)
|
135,986
|
761,024
|
Prepaid expenses and other assets
|
187,379
|
263,915
|
(476,860)
|
Accounts payable
|
5,441,155
|
290,024
|
(944,850)
|
Accrued liabilities and other liabilities
|
5,351,090
|
(282,642)
|
(1,250,047)
|
Deferred revenue
|
1,104,089
|
1,237,009
|
—
|
Net cash provided by (used in) operating activities
|
3,556,780
|
(19,076,030)
|
(29,126,749)
|
Cash flows from investing activities:
|
|
|
|
Purchases of equipment
|
(1,847)
|
(39,001)
|
(1,114,448)
|
Proceeds from sales of equipment
|
45,000
|
38,265
|
—
|
Patent and trademark costs
|
—
|
(27,092)
|
(77,184)
|
Investment in R-NAV, LLC
|
—
|
—
|
(333,334)
|
Payments on disposal of investment in R-NAV, LLC
|
(110,000)
|
—
|
—
|
Proceeds from disposal of investment in R-NAV, LLC
|
27,623
|
—
|
—
|
Net cash used in investing activities
|
(39,224)
|
(27,828)
|
(1,524,966)
|
Cash flows from financing activities:
|
|
|
|
Proceeds from issuance of MT Preferred Stock and
warrants
|
—
|
500,000
|
—
|
Payment of preferred stock issuance costs
|
—
|
(12,587)
|
—
|
Proceeds from issuance of common stock, net
|
13,640
|
65,975
|
87,984
|
Payment of tax withholdings related to stock-based
compensation
|
—
|
(23,906)
|
(130,537)
|
Proceeds from notes payable
|
—
|
54,500,000
|
30,000,000
|
Payment of debt-related costs
|
(3,923,271)
|
(3,902,487)
|
(1,763,526)
|
Principal payments on notes payable
|
(231,453)
|
(30,333,333)
|
(25,000,000)
|
Restricted cash held for payment against debt
|
(5,001,253)
|
—
|
—
|
Payments under capital leases
|
(2,154)
|
(2,550)
|
(2,226)
|
Net cash (used in) provided by financing activities
|
(9,144,491)
|
20,791,112
|
3,191,695
|
Net (decrease) increase in cash
|
(5,626,935)
|
1,687,254
|
(27,460,020)
|
Cash, beginning of period
|
7,166,260
|
5,479,006
|
32,939,026
|
Cash, end of period
|
$1,539,325
|
$7,166,260
|
$5,479,006
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
|||
Expected volatility
|
|
59%-75%
|
|
|
61%-64%
|
|
|
61%-67%
|
|
|||
Weighted-average volatility
|
|
|
60%
|
|
|
|
62%
|
|
|
|
65%
|
|
Expected dividends
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Expected term (in years)
|
|
5.0-6.0
|
|
|
5.1-6.3
|
|
|
5.3-7.4
|
|
|||
Risk-free rate
|
|
1.2%-1.8%
|
|
|
1.5%-1.9%
|
|
|
1.6%-2.0%
|
|
Liabilities Measured at Fair Value on a Recurring Basis as of
December 31, 2016
|
||||
|
Quoted Prices
in Active
Markets for
Identical
Assets and
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs (a)(b)
|
Balance as of
December 31,
|
Description
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
2016
|
Platinum notes payable
|
$—
|
$—
|
$9,641,179
|
$9,641,179
|
Liability related to MT warrants
|
—
|
—
|
63,000
|
63,000
|
Liabilities Measured at Fair Value on a Recurring Basis as of
December 31, 2015
|
||||
|
Quoted Prices
in Active
Markets for
Identical
Assets and
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs (a)(b)
|
Balance as of
December 31,
|
Description
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
2015
|
Platinum notes payable
|
$—
|
$—
|
$11,491,253
|
$11,491,253
|
Liability related to MT warrants
|
—
|
—
|
63,000
|
63,000
|
|
2016
|
2015
|
Estimated volatility
|
76%
|
58%
|
Expected term (in years)
|
4.75
|
5.75
|
Debt rate
|
8.125%
|
14.125%
|
Beginning stock price
|
$0.64
|
$1.33
|
|
Year Ended December 31, 2016
|
|||
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
|
Aggregate
Intrinsic
Value
|
Outstanding at beginning of year
|
5,437,064
|
$1.96
|
|
|
Granted
|
479,457
|
1.05
|
|
|
Exercised
|
(50,000)
|
0.27
|
|
|
Canceled and forfeited
|
(2,186,906)
|
1.69
|
|
|
Expired
|
(299,000)
|
2.42
|
|
|
Outstanding at end of year
|
3,380,615
|
$2.00
|
6.5 years
|
$16,013
|
Exercisable at end of year
|
2,548,681
|
$2.07
|
6.1 years
|
$16,013
|
|
Year Ended
December 31, 2016
|
|
|
Number of
Shares
|
Weighted
Average
Grant-Date
Fair Value
|
Unvested at beginning of year
|
361,000
|
$1.69
|
Granted
|
168,000
|
1.20
|
Forfeited
|
(206,000)
|
1.77
|
Expired
|
(50,000)
|
1.93
|
Vested
|
(66,000)
|
1.65
|
Unvested at end of year
|
207,000
|
$1.17
|
|
Years Ended December 31,
|
||
|
2016
|
2015
|
2014
|
Net loss
|
$(14,039,031)
|
$(27,563,535)
|
$(35,726,669)
|
Less loss attributable to noncontrolling interest
|
(648)
|
(855)
|
—
|
Deemed dividend on beneficial conversion feature
of MT Preferred Stock
|
—
|
(46,000)
|
—
|
Net loss attributable to common stockholders
|
$(14,308,383)
|
$(27,608,680)
|
$(35,726,669)
|
|
|
|
|
Weighted average shares outstanding (basic and
diluted)
|
155,422,384
|
151,180,222
|
148,748,396
|
Loss per common share (basic and diluted)
|
$(0.09)
|
$(0.18)
|
$(0.24)
|
|
2016
|
2015
|
Trade
|
$1,617,414
|
$2,498,087
|
Other
|
184,596
|
1,205,099
|
|
$1,802,010
|
$3,703,186
|
|
2016
|
2015
|
Materials
|
$658,650
|
$330,000
|
Work-in-process
|
616,522
|
392,457
|
Finished goods
|
195,654
|
275,168
|
Reserves
|
—
|
(344,719)
|
|
$1,470,826
|
$652,906
|
|
Useful Life
|
2016
|
2015
|
Production machinery and equipment
|
5 years
|
$1,163,252
|
$1,427,472
|
Other machinery and equipment, primarily computers and
research equipment
|
3 – 5 years
|
407,201
|
421,318
|
Furniture and fixtures
|
7 years
|
645,922
|
648,131
|
Software
|
3 years
|
470,669
|
476,530
|
Leasehold improvements*
|
Term of Lease
|
897,584
|
897,584
|
|
$3,584,628
|
$3,871,035
|
|
2016
|
2015
|
Interest
|
$5,756,519
|
$478
|
Contracted services
|
1,341,601
|
1,887,281
|
Compensation
|
945,787
|
873,726
|
Royalties
|
139,957
|
175,679
|
Other
|
281,651
|
101,549
|
|
$8,465,515
|
$3,038,713
|
|
Exercise
Price
|
Number of
Warrants
|
Expiration Date
|
Series BB
|
$2.00
|
300,000
|
July 2018
|
Series HH
|
2.49
|
301,205
|
June 2023
|
Series II
|
3.04
|
275,000
|
June 2018
|
Series KK
|
1.918
|
391,032
|
March 2021
|
Series LL
|
0.01
|
9,777,130
|
August 2035
|
Series MM
|
2.50
|
150,000
|
September 2019
|
Series MM
|
2.50
|
150,000
|
October 2019
|
|
$0.33*
|
11,344,367
|
|
|
As of December 31,
|
|
|
2016
|
2015
|
Deferred tax assets:
|
|
|
Net operating loss carryforwards
|
$66,150,646
|
$60,129,827
|
R&D credit carryforwards
|
9,729,673
|
9,465,900
|
Stock compensation
|
1,368,458
|
1,898,394
|
Intangibles
|
1,720,761
|
1,921,934
|
Temporary differences
|
132,475
|
801,002
|
Deferred tax assets before valuation allowance
|
79,102,014
|
74,217,057
|
Valuation allowance
|
(79,102,014)
|
(74,217,057)
|
Net deferred tax assets
|
$—
|
$—
|
|
|
As of December 31, 2016
|
|
Generated
|
Expiration
|
U.S. Net
Operating
Loss
Carryforwards
|
U.S. R&D
Credit
Carryforwards
|
1998
|
2018
|
$17,142,781
|
$1,173,387
|
1999
|
2019
|
—
|
130,359
|
2000
|
2020
|
—
|
71,713
|
2001
|
2021
|
—
|
39,128
|
2002
|
2022
|
1,282,447
|
5,350
|
2003
|
2023
|
337,714
|
2,905
|
2004
|
2024
|
1,237,146
|
22,861
|
2005
|
2025
|
2,999,083
|
218,332
|
2006
|
2026
|
3,049,735
|
365,541
|
2007
|
2027
|
2,842,078
|
342,898
|
2008
|
2028
|
2,777,503
|
531,539
|
2009
|
2029
|
13,727,950
|
596,843
|
2010
|
2030
|
5,397,680
|
1,094,449
|
2011
|
2031
|
1,875,665
|
1,950,744
|
2012
|
2032
|
28,406,659
|
468,008
|
2013
|
2033
|
37,450,522
|
681,772
|
2014
|
2034
|
34,088,874
|
816,116
|
2015
|
2035
|
25,073,846
|
492,732
|
2016
|
2036
|
15,581,209
|
358,404
|
Total carryforwards
|
$193,270,891
|
$9,363,081
|
|
Years Ended December 31,
|
|||||
|
2016
|
2015
|
2014
|
|||
|
Amount
|
%
|
Amount
|
%
|
Amount
|
%
|
Benefit at statutory rate
|
$(4,864,851)
|
(34.0)%
|
$(9,777,786)
|
(34.0)%
|
$(12,147,068)
|
(34.0)%
|
Adjustments to valuation allowance
|
4,838,082
|
33.8%
|
9,728,667
|
33.8%
|
12,925,380
|
36.2%
|
Adjustments to R&D credit
carryforwards
|
(239,049)
|
(1.6)%
|
(612,087)
|
(2.1)%
|
(340,886)
|
(1.0)%
|
Disqualified debt interest
|
188,060
|
1.3%
|
438,007
|
1.5%
|
—
|
0.0%
|
Permanent items and other
|
77,758
|
0.5%
|
(212,852)
|
(0.7)%
|
(437,426)
|
(1.2)%
|
Benefit per financial statements
|
$—
|
|
$(436,051)
|
|
$—
|
|
Year Ended December 31, 2016
|
Diagnostics
|
Therapeutics
|
Corporate
|
Total
|
Lymphoseek sales revenue:
|
|
|
|
|
United States (a)
|
$16,982,234
|
$—
|
$—
|
$16,982,234
|
International
|
54,864
|
—
|
—
|
54,864
|
Lymphoseek license revenue
|
1,795,625
|
—
|
—
|
1,795,625
|
Grant and other revenue
|
3,012,217
|
124,766
|
—
|
3,136,983
|
Total revenue
|
21,844,940
|
124,766
|
—
|
21,969,706
|
Cost of goods sold, excluding depreciation and
amortization
|
2,192,902
|
—
|
—
|
2,192,902
|
Research and development expenses,
excluding depreciation and
amortization
|
8,120,425
|
762,151
|
—
|
8,882,576
|
Selling, general and administrative expenses,
excluding depreciation and
amortization (b)
|
3,652,154
|
63,158
|
8,901,022
|
12,616,334
|
Depreciation and amortization
(c)
|
104,138
|
—
|
397,231
|
501,369
|
Income (loss) from operations
(d)
|
7,775,321
|
(700,543)
|
(9,298,253)
|
(2,223,475)
|
Other income (expense), excluding
equity in the loss of
R-NAV, LLC (e)
|
—
|
—
|
(12,070,397)
|
(12,070,397)
|
Equity in the loss of R-NAV, LLC
|
—
|
—
|
(15,159)
|
(15,159)
|
Net income (loss)
|
7,775,321
|
(700,543)
|
(21,383,809)
|
(14,309,031)
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
United States
|
$3,610,354
|
$15,075
|
$8,703,714
|
$12,329,143
|
International
|
131,752
|
—
|
781
|
132,533
|
Capital expenditures
|
—
|
—
|
1,847
|
1,847
|
Year Ended December 31, 2015
|
Diagnostics
|
Therapeutics
|
Corporate
|
Total
|
Lymphoseek sales revenue:
|
|
|
|
|
United States (a)
|
$10,229,659
|
$—
|
$—
|
$10,229,659
|
International
|
24,693
|
—
|
—
|
24,693
|
Lymphoseek license revenue
|
1,133,333
|
—
|
—
|
1,133,333
|
Grant and other revenue
|
1,861,622
|
—
|
—
|
1,861,622
|
Total revenue
|
13,249,307
|
—
|
—
|
13,249,307
|
Cost of goods sold, excluding depreciation and
amortization
|
1,654,800
|
—
|
—
|
1,654,800
|
Research and development expenses,
excluding depreciation and
amortization
|
12,046,221
|
730,895
|
—
|
12,777,116
|
Selling, general and administrative expenses,
excluding depreciation and
amortization (b)
|
5,852,214
|
123,884
|
10,820,392
|
16,796,490
|
Depreciation and amortization
(c)
|
281,314
|
—
|
290,105
|
571,419
|
Loss from operations (d)
|
(6,585,242)
|
(854,779)
|
(11,110,497)
|
(18,550,518)
|
Other income (expense), excluding
equity in the loss of
R-NAV, LLC (e)
|
—
|
—
|
(9,902,424)
|
(9,902,424)
|
Equity in the loss of R-NAV, LLC
|
—
|
—
|
(305,253)
|
(305,253)
|
Benefit from income taxes
|
—
|
—
|
436,051
|
436,051
|
Net loss from continuing operations
|
(6,585,242)
|
(854,779)
|
(20,882,123)
|
(28,322,144)
|
Income from discontinued operations, net of
tax effect (f)
|
—
|
—
|
758,609
|
758,609
|
Net loss
|
(6,585,242)
|
(854,779)
|
(20,123,514)
|
(27,563,535)
|
Total assets, net of depreciation and amortization:
|
|
|
|
|
United States
|
$3,948,971
|
$—
|
$10,603,863
|
$14,552,834
|
International
|
410,666
|
—
|
1,013
|
411,679
|
Capital expenditures
|
26,589
|
—
|
12,412
|
39,001
|
|
Operating
Leases
|
2017
|
$277,946
|
2018
|
284,246
|
2019
|
290,734
|
2020
|
297,405
|
2021
|
304,201
|
Thereafter
|
253,339
|
|
$1,707,871
|
|
For the Quarter Ending
|
|||
|
March 31
|
June 30
|
September 30
|
December 31
|
2016:
|
|
|
|
|
Lymphoseek sales revenue
|
$3,783
|
$4,232
|
$6,690
|
$2,332
|
Lymphoseek license revenue
|
254
|
246
|
1,296
|
—
|
Grant and other revenue
|
686
|
917
|
511
|
1,023
|
Gross profit
|
4,188
|
4,834
|
7,575
|
3,076
|
Operating expenses
|
6,756
|
5,414
|
4,217
|
5,509
|
Operating income (loss)
|
(2,568)
|
(580)
|
3,358
|
(2,433)
|
Net loss attributable to common stockholders
|
(3,686)
|
(6,681)
|
(59)
|
(3,883)
|
Basic and diluted net loss per share
(1)
|
$(0.02)
|
$(0.04)
|
$(0.00)
|
$(0.03)
|
|
|
|
|
|
2015:
|
|
|
|
|
Lymphoseek sales revenue
|
$1,835
|
$1,964
|
$2,953
|
$3,503
|
Lymphoseek license revenue
|
83
|
250
|
550
|
250
|
Grant and other revenue
|
190
|
654
|
477
|
541
|
Gross profit
|
1,659
|
2,535
|
3,522
|
3,778
|
Operating expenses
|
9,475
|
6,346
|
7,845
|
6,379
|
Operating loss
|
(7,816)
|
(3,811)
|
(4,323)
|
(2,601)
|
Net loss attributable to common stockholders
|
(7,337)
|
(9,691)
|
(8,071)
|
(2,510)
|
Basic and diluted net loss per share
(1)
|
$(0.05)
|
$(0.06)
|
$(0.05)
|
$(0.02)
|
Subsidiaries
|
Jurisdiction of
Incorporation
|
Percentage Owned
by Registrant
|
|
Cardiosonix
Ltd.
|
Israel
|
100%
|
|
Navidea
Biopharmaceuticals Limited
|
United
Kingdom
|
100%
|
|
Macrophage
Therapeutics, Inc.
|
Delaware, United
States
|
99.9%
|
|
|
Signature
|
|
Title
|
|
|
/s/
Michael M. Goldberg
|
|
President,
Chief Executive Officer and Director
(principal
executive officer)
|
|
|
Michael
M. Goldberg, M.D.
|
|
|
||
|
|
|
|
|
/s/ Jed
A. Latkin
|
|
Interim
Chief Operating Officer and Chief Financial Officer
(principal
financial officer and principal accounting officer)
|
|
|
Jed A.
Latkin
|
|
|
||
|
|
|
|
|
/s/
Eric K. Rowinsky
|
|
Chairman
of the Board of Directors
|
|
|
Eric K.
Rowinsky, M.D.
|
|
|
||
|
|
|
|
|
/s/
Anthony S. Fiorino
|
|
Director
|
|
|
Anthony
S. Fiorino, M.D., Ph.D.
|
|
|
||
|
|
|
|
|
/s/
Mark I. Greene
|
|
Director
|
|
|
Mark I.
Greene, M.D., Ph.D., FRCP
|
|
|
||
|
|
|
|
|
/s/ Y.
Michael Rice
|
|
Director
|
|
|
Y.
Michael Rice
|
|
|
|
|
|
|
/s/
Michael M. Goldberg
|
|
|
Michael
M. Goldberg, M.D.
|
|
President and Chief
Executive Officer
|
|
|
|
|
March
31, 2017
|
/s/ Jed
A. Latkin
|
|
Jed A.
Latkin
|
|
March
31, 2017
|
/s/
Michael M. Goldberg
|
|
|
|
President and Chief
Executive Officer
|
March
31, 2017
|
/s/ Jed
A. Latkin
|
|
Jed A.
Latkin
|
|
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Document and Entity Information - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Mar. 01, 2017 |
Jun. 30, 2016 |
|
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Entity Registrant Name | NAVIDEA BIOPHARMACEUTICALS, INC. | ||
Trading Symbol | NAVB | ||
Entity Central Index Key | 0000810509 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2016 | ||
Document Fiscal Period Focus | FY | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 161,898,338 | ||
Entity Public Float | $ 84,031,238 |
Consolidated Balance Sheets (Parenthetical) - USD ($) |
Dec. 31, 2016 |
Dec. 31, 2015 |
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Statement of Financial Position [Abstract] | ||
Notes payable, discounts | $ 0 | $ 2,033,506 |
Preferred Stock, Par Value | $ .001 | $ 0.001 |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par Value | $ .001 | $ .001 |
Common Stock, Shares Authorized | 300,000,000 | 200,000,000 |
Common Stock, Shares, Issued | 155,762,729 | 155,649,665 |
Common Stock, Shares Outstanding | 155,762,729 | 155,649,665 |
Consolidated Statements of Operations - USD ($) |
12 Months Ended | ||
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Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
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Revenue: | |||
Lymphoseek sales revenue | $ 17,037,098 | $ 10,254,352 | $ 4,233,953 |
Lymphoseek license revenue | 1,795,625 | 1,133,333 | 300,000 |
Grant and other revenue | 3,136,983 | 1,861,622 | 1,740,896 |
Total revenue | 21,969,706 | 13,249,307 | 6,274,849 |
Cost of goods sold | 2,297,040 | 1,754,763 | 1,586,145 |
Gross profit | 19,672,666 | 11,494,544 | 4,688,704 |
Operating expenses: | |||
Research and development | 8,882,576 | 12,787,733 | 16,779,589 |
Selling, general and administrative | 13,013,565 | 17,257,329 | 15,542,071 |
Total operating expenses | 21,896,141 | 30,045,062 | 32,321,660 |
Loss from operations | (2,223,475) | (18,550,518) | (27,632,956) |
Other income (expense): | |||
Interest expense, net | (14,861,270) | (6,873,736) | (3,690,068) |
Equity in loss of R-NAV, LLC | (15,159) | (305,253) | (523,809) |
Loss on disposal of investment in R-NAV, LLC | (39,732) | 0 | 0 |
Change in fair value of financial instruments | 2,858,524 | (614,782) | (1,342,389) |
Loss on extinguishment of debt | 0 | (2,440,714) | (2,610,196) |
Other, net | (27,919) | 26,808 | 72,749 |
Total other expense, net | (12,085,556) | (10,207,677) | (8,093,713) |
Loss before income taxes | (14,309,031) | (28,758,195) | (35,726,669) |
Benefit from income taxes | 0 | 436,051 | 0 |
Loss from continuing operations | (14,309,031) | (28,322,144) | (35,726,669) |
Income from discontinued operations, net of tax effect | 0 | 758,609 | 0 |
Net loss | (14,309,031) | (27,563,535) | (35,726,669) |
Less loss attributable to noncontrolling interest | (648) | (855) | 0 |
Deemed dividend on beneficial conversion feature of MT Preferred Stock | 0 | (46,000) | 0 |
Net loss attributable to common stockholders | $ (14,308,383) | $ (27,608,680) | $ (35,726,669) |
(Loss) income per common share (basic and diluted): | |||
Continuing operations | $ (0.09) | $ (0.19) | $ (0.24) |
Discontinued operations | 0.00 | 0.01 | 0.00 |
Attributable to common stockholders | $ (0.09) | $ (0.18) | $ (0.24) |
Weighted average shares outstanding (basic and diluted) | 155,422,384 | 151,180,222 | 148,748,396 |
Organization and Summary of Significant Accounting Policies |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization and Summary of Significant Accounting Policies | a. Organization and Nature of Operations: Navidea Biopharmaceuticals, Inc. (“Navidea,” the “Company,” or “we”), a Delaware Corporation (NYSE MKT: NAVB), is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on our Manocept™ platform to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Lymphoseek® (technetium Tc 99m tilmanocept) injection, the first product developed and commercialized by Navidea based on the platform. Building on the success of Tc 99m tilmanocept, the flexible and versatile Manocept platform acts as an engine for the design of purpose-built molecules offering the potential to be utilized across a range of diagnostic modalities, including single photon emission computed tomography (“SPECT”), positron emission tomography (“PET”), intra-operative and/or optical-fluorescence detection in a variety of disease states. On March 3, 2017, pursuant to an Asset Purchase Agreement dated November 23, 2016, (the “Purchase Agreement”), the Company completed its previously announced sale to Cardinal Health 414, LLC (“Cardinal Health 414”) of its assets used, held for use, or intended to be used in operating its business of developing, manufacturing and commercializing a product used for lymphatic mapping, lymph node biopsy, and the diagnosis of metastatic spread to lymph nodes for staging of cancer (the “Business”), including the Company’s radioactive diagnostic agent marketed under the Lymphoseek® trademark for current approved indications by the U.S. Food and Drug Administration (“FDA”) and similar indications approved by the FDA in the future (the “Product”), in Canada, Mexico and the United States (the “Territory”) (giving effect to the License-Back described below and excluding certain assets specifically retained by the Company) (the “Asset Sale”). Such assets sold in the Asset Sale consist primarily of, without limitation, (i) intellectual property used in or reasonably necessary for the conduct of the Business, (ii) inventory of, and customer, distribution, and product manufacturing agreements related to, the Business, (iii) all product registrations related to the Product, including the new drug application approved by the FDA for the Product and all regulatory submissions in the United States that have been made with respect to the Product and all Health Canada regulatory submissions and, in each case, all files and records related thereto, (iv) all related clinical trials and clinical trial authorizations and all files and records related thereto, and (v) all right, title and interest in and to the Product, as specified in the Purchase Agreement (the “Acquired Assets”). Upon closing of the Asset Sale, the Supply and Distribution Agreement, dated November 15, 2007 (as amended, the “Supply and Distribution Agreement”), between Cardinal Health 414 and the Company was terminated and, as a result, the provisions thereof are of no further force or effect (other than any indemnification, payment, notification or data sharing obligations which survive the termination). The Asset Sale to Cardinal Health 414 in March 2017 significantly improved our financial condition and our ability to continue as a going concern. The Company also continues working to establish new sources of non-dilutive funding, including collaborations and grant funding that can augment the balance sheet as the Company works to reduce spending to levels that can be supported by our revenues. Other than Tc 99m tilmanocept, which the Company has a license to distribute outside of Canada, Mexico and the United States, none of the Company’s drug product candidates have been approved for sale in any market. In January 2015, Macrophage Therapeutics, Inc. (“MT”), a majority-owned subsidiary, was formed specifically to explore immuno-therapeutic applications for the Manocept platform. From our inception through August 2011, we also manufactured a line of gamma detection systems called the neoprobe® GDS system (the “GDS Business”). We sold the GDS Business to Devicor Medical Products, Inc. (“Devicor”) in August 2011. In exchange for the assets of the GDS Business, Devicor made net cash payments to us totaling $30.3 million, assumed certain liabilities of the Company associated with the GDS Business, and agreed to make royalty payments to us of up to an aggregate maximum amount of $20 million based on the net revenue attributable to the GDS Business through 2017. We recorded income of $759,000, net of taxes, in 2015 related to royalty amounts earned based on 2015 GDS Business revenue. The royalty amount of $1.2 million was offset by $436,000 in estimated taxes which were allocated to discontinued operations, but were fully offset by the tax benefit from our net operating loss for 2015. We did not earn or receive any such royalty payments prior to 2015 or in 2016. In December 2001, we acquired Cardiosonix Ltd. (“Cardiosonix”), an Israeli company with a blood flow measurement device product line in the early stages of commercialization. In August 2009, the Company’s Board of Directors decided to discontinue the operations and attempt to sell Cardiosonix. However, we were obligated to continue to service and support the Cardiosonix devices through 2013. The Company has not received significant expressions of interest in the Cardiosonix business and as such, we continue to wind down our activities in this area until a final shutdown of operations is completed.
In July 2011, we established a European business unit, Navidea Biopharmaceuticals Limited, to address international development and commercialization needs for our technologies, including Tc 99m tilmanocept. Navidea owns 100% of the outstanding shares of Navidea Biopharmaceuticals Limited.
b. Principles of Consolidation: Our consolidated financial statements include the accounts of Navidea and our wholly-owned subsidiaries, Navidea Biopharmaceuticals Limited and Cardiosonix Ltd, as well as those of our majority-owned subsidiary, Macrophage Therapeutics, Inc. (“MT”). All significant inter-company accounts were eliminated in consolidation. Prior to termination of Navidea’s joint venture with R-NAV, LLC (“R-NAV”), Navidea's investment in R-NAV was being accounted for using the equity method of accounting and was therefore not consolidated. See Note 10.
c. Use of Estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
d. Financial Instruments and Fair Value: In accordance with current accounting standards, the fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value, giving the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:
Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and
Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In determining the appropriate levels, we perform a detailed analysis of the assets and liabilities whose fair value is measured on a recurring basis. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. See Note 3.
The following methods and assumptions were used to estimate the fair value of each class of financial instruments:
e. Stock-Based Compensation: At December 31, 2016, we have instruments outstanding under two stock-based compensation plans; the Fourth Amended and Restated 2002 Stock Incentive Plan (the “2002 Plan”) and the 2014 Stock Incentive Plan (the “2014 Plan”). Currently, under the 2014 Plan, we may grant incentive stock options, nonqualified stock options, and restricted stock awards to full-time employees and directors, and nonqualified stock options and restricted stock awards may be granted to our consultants and agents. Total shares authorized under each plan are 12 million shares and 5 million shares, respectively. Although instruments are still outstanding under the 2002 Plan, the plan has expired and no new grants may be made from it. Under both plans, the exercise price of each option is greater than or equal to the closing market price of our common stock on the date of the grant.
Stock options granted under the 2002 Plan and the 2014 Plan generally vest on an annual basis over one to four years. Outstanding stock options under the plans, if not exercised, generally expire ten years from their date of grant or up to 90 days following the date of an optionee’s separation from employment with the Company. We issue new shares of our common stock upon exercise of stock options.
In September 2016, the Board of Directors approved the 2016 Stock Incentive Plan (the “2016 Plan”), authorizing a total of 10 million shares. The 2016 Plan has not yet been approved by Navidea’s stockholders. In connection with Dr. Goldberg’s appointment as Chief Executive Officer of the Company in September 2016, the Board of Directors awarded options to purchase 5,000,000 shares of our common stock to Dr. Goldberg, subject to stockholder approval of the 2016 Plan. If approved, these stock options will vest 100% when the average closing price of the Company’s common stock over a period of five consecutive trading days equals or exceeds $2.50 per share, and expire on the tenth anniversary of the date of grant.
Stock-based payments to employees and directors, including grants of stock options, are recognized in the consolidated statement of operations based on their estimated fair values. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Expected volatilities are based on the Company’s historical volatility, which management believes represents the most accurate basis for estimating expected future volatility under the current circumstances. Navidea uses historical data to estimate forfeiture rates. The expected term of stock options granted is based on the vesting period and the contractual life of the options. The risk-free rate is based on the U.S. Treasury yield in effect at the time of the grant. The assumptions used to calculate the fair value of stock option awards granted during the years ended December 31, 2016, 2015 and 2014 are noted in the following table:
The portion of the fair value of stock-based awards that is ultimately expected to vest is recognized as compensation expense over either (1) the requisite service period or (2) the estimated performance period. Restricted stock awards are valued based on the closing stock price on the date of grant and amortized ratably over the estimated life of the award. Restricted stock may vest based on the passage of time, or upon occurrence of a specific event or achievement of goals as defined in the grant agreements. In such cases, we record compensation expense related to grants of restricted stock based on management’s estimates of the probable dates of the vesting events. Stock-based awards that do not vest because the requisite service period is not met prior to termination result in reversal of previously recognized compensation cost. See Note 4.
f. Cash and Cash Equivalents: Cash equivalents are highly liquid instruments such as U.S. Treasury bills, bank certificates of deposit, corporate commercial paper and money market funds which have maturities of less than 3 months from the date of purchase.
g. Accounts and Other Receivables: Accounts and other receivables are recorded net of an allowance for doubtful accounts. We estimate an allowance for doubtful accounts based on a review and assessment of specific accounts and other receivables and write off accounts when deemed uncollectible. See Note 6.
h. Inventory: All components of inventory are valued at the lower of cost (first-in, first-out) or market. We adjust inventory to market value when the net realizable value is lower than the carrying cost of the inventory. Market value is determined based on estimated sales activity and margins. We estimate a reserve for obsolete inventory based on management’s judgment of probable future commercial use, which is based on an analysis of current inventory levels, estimated future sales and production rates, and estimated shelf lives. See Note 7.
i. Property and Equipment: Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is generally computed using the straight-line method over the estimated useful lives of the depreciable assets. Depreciation and amortization related to equipment under capital leases and leasehold improvements is recognized over the shorter of the estimated useful life of the leased asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized. See Note 8.
j. Intangible Assets: Intangible assets consist primarily of patents and trademarks. Intangible assets are stated at cost, less accumulated amortization. Patent costs are amortized using the straight-line method over the estimated useful lives of the patents of approximately 5 to 15 years. Patent application costs are deferred pending the outcome of patent applications. Costs associated with unsuccessful patent applications and abandoned intellectual property are expensed when determined to have no recoverable value. We evaluate the potential alternative uses of all intangible assets, as well as the recoverability of the carrying values of intangible assets, on a recurring basis.
k. Impairment or Disposal of Long-Lived Assets: Long-lived assets and certain identifiable intangibles are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. No impairment was recognized during the years ended December 31, 2016, 2015 or 2014. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell.
l. Leases: Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet. See Note 20.
m. Derivative Instruments: Derivative instruments embedded in contracts, to the extent not already a free-standing contract, are bifurcated from the debt instrument and accounted for separately. All derivatives are recorded on the consolidated balance sheet at fair value in accordance with current accounting guidelines for such complex financial instruments. Derivative liabilities with expiration dates within one year are classified as current, while those with expiration dates in more than one year are classified as long term. We do not use derivative instruments for hedging of market risks or for trading or speculative purposes.
n. Revenue Recognition: Prior to the Asset Sale to Cardinal Health 414 in March 2017, we generated revenue primarily from sales of Lymphoseek. Our standard shipping terms are free on board (FOB) shipping point, and title and risk of loss passes to the customer upon delivery to a carrier for shipment. We generally recognize sales revenue related to sales of our products when the products are shipped. Our customers have no right to return products purchased in the ordinary course of business, however, we may allow returns in certain circumstances based on specific agreements.
We earned additional revenues based on a percentage of the actual net revenues achieved by Cardinal Health 414 on sales to end customers made during each fiscal year. The amount we charged Cardinal Health 414 related to end customer sales of Lymphoseek was subject to a retroactive annual adjustment. To the extent that we could reasonably estimate the end-customer prices received by Cardinal Health 414, we recorded sales based upon these estimates at the time of sale. If we were unable to reasonably estimate end customer sales prices related to products sold, we recorded revenue related to these product sales at the minimum (i.e., floor) price provided for under our distribution agreement with Cardinal Health 414. During the years ended December 31, 2016 and 2015, approximately 99% of Lymphoseek sales were made to Cardinal Health 414.
We also earn revenues related to our licensing and distribution agreements. The terms of these agreements may include payment to us of non-refundable upfront license fees, funding or reimbursement of research and development efforts, milestone payments if specified objectives are achieved, and/or royalties on product sales. We evaluate all deliverables within an arrangement to determine whether or not they provide value on a stand-alone basis. We recognize a contingent milestone payment as revenue in its entirety upon our achievement of a substantive milestone if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. We received a non-refundable upfront cash payment of $2.0 million from SpePharm AG upon execution of the SpePharm License Agreement in March 2015. We have determined that the license and other non-contingent deliverables do not have stand-alone value because the license could not be deemed to be fully delivered for its intended purpose unless we perform our other obligations, including specified development work. Accordingly, they do not meet the separation criteria, resulting in these deliverables being considered a single unit of account. As a result, revenue relating to the upfront cash payment was deferred and was being recognized on a straight-line basis over the estimated obligation period of two years. However, the remaining deferred revenue of $417,000 was recognized upon obtaining European approval of a reduced-mass vial in September 2016, several months earlier than originally anticipated.
We generate additional revenue from grants to support various product development initiatives. We generally recognize grant revenue when expenses reimbursable under the grants have been paid and payments under the grants become contractually due. Lastly, we recognized revenues from the provision of services to R-NAV and its subsidiaries through the termination of the R-NAV joint venture on May 31, 2016. See Note 10.
o. Research and Development Costs: Research and development (?R&D?) expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits, and stock-based compensation, as well as travel, supplies, and other costs to support our R&D staff. External contracted services include clinical trial activities, manufacturing and control-related activities, and regulatory costs. R&D expenses are charged to operations as incurred. We review and accrue R&D expenses based on services performed and rely upon estimates of those costs applicable to the stage of completion of each project.
p. Income Taxes: Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Due to the uncertainty surrounding the realization of the deferred tax assets in future tax returns, all of the deferred tax assets have been fully offset by a valuation allowance at December 31, 2016 and 2015.
Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no liability for uncertain tax positions was recorded as of December 31, 2016 or 2015 and we do not expect any significant changes in the next twelve months. Should we need to accrue interest or penalties on uncertain tax positions, we would recognize the interest as interest expense and the penalties as a selling, general and administrative expense. As of December 31, 2016, tax years 2013-2016 remained subject to examination by federal and state tax authorities. See Note 17.
q. Change in Accounting Principle: In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-03, Simplifying the Presentation of Debt Issuance Costs. ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability rather than as an asset. The recognition and measurement guidance for debt issuance costs are not affected by ASU 2015-03. ASU 2015-03 was effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption was permitted. Entities must apply the amendments in ASU 2015-03 on a retrospective basis. In 2015, the Company adopted ASU 2015-03. We have reflected all remaining unamortized costs as a reduction of the debt on the balance sheets as of December 31, 2016 and 2015, and will continue to do so in future periods. The adoption of ASU 2015-03 had no impact on the consolidated statements of operations, stockholders' deficit or cash flows. In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes. ASU 2015-17 eliminates the requirement to bifurcate deferred taxes between current and noncurrent on the balance sheet and requires that deferred tax assets and liabilities be classified as noncurrent on the balance sheet. ASU 2015-17 may be applied retrospectively or prospectively and early adoption is permitted. We early-adopted ASU 2015-17 as of December 31, 2015 and the statement of financial position as of this date reflects the revised classification of current deferred tax assets and liabilities as noncurrent. Adoption of ASU 2015-17 resulted in a retrospective reclassification between current deferred tax assets and noncurrent deferred tax assets.
r. Recent Accounting Developments: In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 defines when and how companies are required to disclose going concern uncertainties, which must be evaluated each interim and annual period. ASU 2014-15 requires management to determine whether substantial doubt exists regarding the entity's going concern presumption. Substantial doubt about an entity's ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued (or available to be issued). If substantial doubt exists, certain disclosures are required; the extent of those disclosures depends on an evaluation of management's plans (if any) to mitigate the going concern uncertainty. ASU 2014-15 is effective prospectively for annual periods ending after December 15, 2016, and to annual and interim periods thereafter. Early adoption was permitted. The adoption of ASU 2014-15 did not have any effect on our consolidated financial statements, however it does affect disclosures.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). ASU 2016-02 requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. We expect the adoption of ASU 2016-02 to result in an increase in right-of-use assets and lease liabilities on our consolidated statement of financial position related to our leases that are currently classified as operating leases, primarily for office space. Management is currently evaluating the impact that the adoption of ASU 2016-02 will have on our consolidated financial statements.
In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers – Principal versus Agent Considerations (Reporting Revenue Gross versus Net). ASU 2016-08 does not change the core principle of the guidance, rather it clarifies the implementation guidance on principal versus agent considerations. ASU 2016-08 clarifies the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-08 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2014-09 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation. ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Some of the simplified areas apply only to nonpublic entities. ASU 2016-09 is effective for public business entities for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period. If an entity early adopts ASU 2016-09 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. Methods of adoption vary according to each of the amendment provisions. Management is currently evaluating the impact that the adoption of ASU 2016-09 will have on our consolidated financial statements.
In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers – Identifying Performance Obligations and Licensing. ASU 2016-10 does not change the core principle of the guidance, rather it clarifies the identification of performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. ASU 2016-10 clarifies the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-10 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016-120 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers – Narrow-Scope Improvements and Practical Expedients. ASU 2016-12 does not change the core principle of the guidance, rather it affects only certain narrow aspects of Topic 606, including assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. ASU 2016-12 affects the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-12 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016-12 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 addresses certain specific cash flow issues with the objective of reducing the existing diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement cash flows. ASU 2016-15 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted in any interim or annual period. If an entity early adopts ASU 2016-15 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. ASU 2016-15 should be applied using a retrospective transition method to each period presented, with certain exceptions. We adopted ASU 2016-15 upon issuance, which resulted in debt prepayment costs being classified as financing costs rather than operating costs on the statement of cash flows for the year ended December 31, 2016.
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows – Restricted Cash. ASU 2016-18 requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and restricted cash or equivalents. Therefore, restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption in permitted, including adoption in an interim period. If an entity early adopts ASU 2016-18 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes the interim period. Following the payoff of our CRG debt and release of our restricted cash in March 2017, we do not expect the adoption of ASU 2016-18 to have a material effect on our consolidated financial statements.
In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. ASU 2016-20 does not change the core principle of the guidance, rather it affects only certain narrow aspects of Topic 606, including loan guarantee fees, contract cost impairment testing, provisions for losses on construction- and production-type contracts, clarification of the scope of Topic 606, disclosure of remaining and prior-period performance obligations, contract modification, contract asset presentation, refund liability, advertising costs, fixed-odds wagering contracts in the casino industry, and cost capitalization for advisors to private and public funds. ASU 2016-20 affects the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-12 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016-20 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business. ASU 2017-01 provides a screen to determine when a set of assets and activities (collectively, a “set”) is not a business. The screen requires that when substantially all of the fair market value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. If the screen is not met, ASU 2017-01 (1) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output, and (2) removes the evaluation of whether a market participant could replace missing elements. ASU 2017-01 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those periods. ASU 2017-01 should be applied prospectively on or after the effective date. No disclosures are required at transition. Early adoption is permitted for certain transactions as described in ASU 2017-01. Management is currently evaluating the impact that the adoption of ASU 2017-01 will have on our consolidated financial statements. |
Liquidity |
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Dec. 31, 2016 | |
Liquidity [Abstract] | |
Liquidity | Prior to the Asset Sale to Cardinal Health 414 in March 2017, all of our material assets, except our intellectual property, were pledged as collateral for our borrowings under the Term Loan Agreement (the “CRG Loan Agreement”) with CRG. In addition to the security interest in our assets, the CRG Loan Agreement carried covenants that imposed significant requirements on us, including, among others, requirements that we (1) pay all principal, interest and other charges on the outstanding balance of the borrowed funds when due; (2) maintain liquidity of at least $5 million during the term of the CRG Loan Agreement; and (3) meet certain annual EBITDA or revenue targets ($22.5 million of Tc 99m tilmanocept sales revenue in 2016) as defined in the CRG Loan Agreement. The events of default under the CRG Loan Agreement also included a failure of Platinum-Montaur Life Sciences LLC, an affiliate of Platinum Management (NY) LLC, Platinum Partners Value Arbitrage Fund L.P., Platinum Partners Liquid Opportunity Master Fund L.P., Platinum Liquid Opportunity Management (NY) LLC, and Montsant Partners LLC (collectively, “Platinum”) to perform its funding obligations under the Platinum Loan Agreement (as defined below) at any time as to which the Company had negative EBITDA for the most recent fiscal quarter, as a result either of Platinum’s repudiation of its obligations under the Platinum Loan Agreement, or the occurrence of an insolvency event with respect to Platinum. An event of default would have entitled CRG to accelerate the maturity of our indebtedness, increase the interest rate from 14% to the default rate of 18% per annum, and invoke other remedies available to it under the loan agreement and the related security agreement.
During the course of 2016, CRG alleged multiple claims of default on the CRG Loan Agreement, and filed suit in the District Court of Harris County, Texas. On June 22, 2016, CRG exercised control over one of the Company’s primary bank accounts and took possession of $4.1 million that was on deposit.
On March 3, 2017, the Company entered into a Global Settlement Agreement with MT, CRG, and Cardinal Health 414 to effectuate the terms of the settlement previously entered into by the parties on February 22, 2017. In accordance with the Global Settlement Agreement, on March 3, 2017, the Company repaid $59 million (the “Deposit Amount”) of its alleged indebtedness and other obligations outstanding under the CRG Term Loan. Concurrently with payment of the Deposit Amount, CRG released all liens and security interests granted under the CRG Loan Documents and the CRG Loan Documents were terminated and are of no further force or effect; provided, however, that, notwithstanding the foregoing, the Company and CRG agreed to continue with their proceeding pending in The District Court of Harris County, Texas to fully and finally determine the actual amount owed by the Company to CRG under the CRG Loan Documents (the “Final Payoff Amount”). The Company and CRG further agreed that the Final Payoff Amount would be no less than $47 million (the “Low Payoff Amount”) and no more than $66 million (the “High Payoff Amount”). In addition, concurrently with the payment of the Deposit Amount and closing of the Asset Sale, (i) Cardinal Health 414 agreed to post a $7 million letter of credit in favor of CRG (at the Company’s cost and expense to be deducted from the closing proceeds due to the Company, and subject to Cardinal Health 414’s indemnification rights under the Purchase Agreement) as security for the amount by which the High Payoff Amount exceeds the Deposit Amount in the event the Company is unable to pay all or a portion of such amount, and (ii) CRG agreed to post a $12 million letter of credit in favor of the Company as security for the amount by which the Deposit Amount exceeds the Low Payoff Amount. If, on the one hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents exceeds the Deposit Amount, the Company will pay such excess amount, plus the costs incurred by CRG in obtaining CRG’s letter of credit, to CRG and if, on the other hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents is less than the Deposit Amount, CRG will pay such difference to the Company and reimburse Cardinal Health 414 for the costs incurred by Cardinal Health 414 in obtaining its letter of credit. Any payments owing to CRG arising from a final determination that the Final Payoff Amount is in excess of $59 million shall first be paid by the Company without resort to the letter of credit posted by Cardinal Health 414, and such letter of credit shall only be a secondary resource in the event of failure of the Company to make payment to CRG. The Company will indemnify Cardinal Health 414 for any costs it incurs in payment to CRG under the settlement, and the Company and Cardinal Health 414 further agree that Cardinal Health 414 can pursue all possible remedies, including offset against earnout payments (guaranteed or otherwise) under the Purchase Agreement, warrant exercise, or any other payments owed by Cardinal Health 414, or any of its affiliates, to the Company, or any of its affiliates, if Cardinal Health 414 incurs any cost associated with payment to CRG under the settlement. The Company and CRG also agreed that the $2 million being held in escrow pursuant to court order in the Ohio case and the $3 million currently being held in escrow pursuant to court order in the Texas case would be released to the Company at closing of the Asset Sale. On March 3, 2017, Cardinal Health 414 posted a $7 million letter of credit, and on March 7, 2017, CRG posted a $12 million letter of credit, each as required by the Global Settlement Agreement. See Notes 12 and 24(b).
In addition, our Loan Agreement with Platinum (the “Platinum Loan Agreement”) carries standard non-financial covenants typical for commercial loan agreements, many of which are similar to those contained in the CRG Loan Agreement, that impose significant requirements on us. Our ability to comply with these provisions may be affected by changes in our business condition or results of our operations, or other events beyond our control. The breach of any of these covenants would result in a default under the Platinum Loan Agreement, permitting Platinum to terminate our ability to obtain additional draws under the Platinum Loan Agreement and accelerate the maturity of the debt, subject to the limitations of the Subordination Agreement with CRG. Such actions by Platinum could materially adversely affect our operations, results of operations and financial condition, including causing us to substantially curtail our product development activities.
The Platinum Loan Agreement includes a covenant that results in an event of default on the Platinum Loan Agreement upon default on the CRG Loan Agreement. As discussed above, the Company is maintaining its position that CRG’s alleged claims do not constitute events of default under the CRG Loan Agreement and believes it has defenses against such claims. The Company has obtained a waiver from Platinum confirming that we are not in default under the Platinum Loan Agreement as a result of the alleged default on the CRG Loan Agreement and as such, we are currently in compliance with all covenants under the Platinum Loan Agreement.
In connection with the closing of the Asset Sale to Cardinal Health 414, the Company repaid to Platinum Partners Credit Opportunities Master Fund, LP (“PPCO”) an aggregate of approximately $7.7 million in partial satisfaction of the Company’s liabilities, obligations and indebtedness under the Platinum Loan Agreement between the Company and Platinum-Montaur Life Sciences, LLC (“Platinum-Montaur”), which, to the extent of such payment, were transferred by Platinum-Montaur to PPCO. The Company was informed by Platinum Partners Value Arbitrage Fund LP (“PPVA”) that it was the owner of the balance of the Platinum-Montaur loan. Such balance of approximately $1.9 million was due upon closing of the Asset Sale but withheld by the Company and not paid to anyone as it is subject to competing claims of ownership by both Dr. Michael Goldberg, the Company’s President and Chief Executive Officer, and PPVA. See Notes 12 and 24(c).
Post-closing and after paying off our outstanding indebtedness and transaction-related expenses, Navidea has approximately $15.6 million in cash and $3.7 million in payables, a large portion of which is tied to the 4694 program which Navidea is seeking to divest in the near term. Following the completion of the Asset Sale to Cardinal Health 414 and the repayment of a majority of our indebtedness, we believe that substantial doubt about the Company’s financial position and ability to continue as a going concern has been removed. Although we could still be required to pay up to an additional $7 million to CRG depending upon the outcome of the Texas litigation, the Company believes that the Company will be able to continue as a going concern for at least twelve months following the issuance of this Annual Report on Form 10-K. |
Fair Value |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value |
Platinum has the right to convert into common stock all or any portion of the unpaid principal or unpaid interest accrued on all draws under the Platinum credit facility, under certain circumstances. Platinum’s debt instrument, including the embedded option to convert such debt into common stock, is recorded at fair value on the consolidated balance sheets and deemed to be a derivative instrument as the amount of shares to be issued upon conversion is indeterminable. The estimated fair value of the Platinum notes payable is $9.6 million and $11.5 million at December 31, 2016 and 2015, respectively.
MT issued warrants to purchase MT Common Stock with certain characteristics including a net settlement provision that require the warrants to be accounted for as a derivative liability at fair value on the consolidated balance sheets. The estimated fair value of the MT warrants is $63,000 at both December 31, 2016 and 2015, and will continue to be measured on a recurring basis. See Notes 1(m) and 9.
The following tables set forth, by level, financial liabilities measured at fair value on a recurring basis:
a. Valuation Processes-Level 3 Measurements: The Company utilizes third-party valuation services that use complex models such as Monte Carlo simulation to estimate the value of our financial liabilities. Each reporting period, the Company provides significant unobservable inputs to the third-party valuation experts based on current internal estimates and forecasts. The assumptions used in the Monte Carlo simulation as of December 31, 2016 and 2015 are summarized in the following table:
In addition, as of December 31, 2016 the Company estimated a 95% chance that the majority of the Platinum debt would be repaid in connection with the closing of the Asset Sale to Cardinal Health 414 during the first quarter of 2017.
b. Sensitivity Analysis-Level 3 Measurements: Changes in the Company’s current internal estimates and forecasts are likely to cause material changes in the fair value of certain liabilities. The significant unobservable inputs used in the fair value measurement of the liabilities include the amount and timing of future draws expected to be taken under the Platinum Loan Agreement based on current internal forecasts, management’s estimate of the likelihood of actually making those draws as opposed to obtaining other sources of financing, and management’s estimate of the likelihood of paying off the debt prior to maturity. Significant increases (decreases) in any of the significant unobservable inputs would result in a higher (lower) fair value measurement. A change in one of the inputs would not necessarily result in a directionally similar change in the others.
There were no Level 1 or Level 2 liabilities outstanding at any time during the years ended December 31, 2016 and 2015. There were no transfers in or out of our Level 1 or Level 2 liabilities during the years ended December 31, 2016 and 2015. Changes in the estimated fair value of our Level 3 liabilities relating to unrealized gains (losses) are recorded as changes in fair value of financial instruments in the consolidated statements of operations. The change in the estimated fair value of our Level 3 liabilities during the years ended December 31, 2016, 2015 and 2014 was a decrease of $2.9 million and increases of $615,000 and $1.3 million, respectively.
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Stock-Based Compensation |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | For the years ended December 31, 2016, 2015 and 2014, our total stock-based compensation expense, which includes reversals of expense for certain forfeited or cancelled awards, was approximately $278,000, $2.4 million and $1.6 million, respectively. We have not recorded any income tax benefit related to stock-based compensation for the years ended December 31, 2016, 2015 and 2014.
A summary of the status of our stock options as of December 31, 2016, and changes during the year then ended, is presented below:
The weighted average grant-date fair value of options granted in 2016, 2015, and 2014 was $0.53, $1.67 and $1.56, respectively. During 2016, 50,000 stock options with an aggregate intrinsic value of $23,000 were exercised in exchange for issuance of 50,000 shares of our common stock, resulting in gross proceeds of $13,500. During 2015, 146,625 stock options with an aggregate intrinsic value of $144,000 were exercised in exchange for issuance of 124,238 shares of our common stock, resulting in gross proceeds of $66,000. During 2014, 468,000 stock options with an aggregate intrinsic value of $582,000 were exercised in exchange for issuance of 299,360 shares of our common stock, resulting in gross proceeds of $70,000. In 2016, 2015, and 2014, the aggregate fair value of stock options vested during the year was $3,000, $277,000 and $4,000, respectively.
A summary of the status of our unvested restricted stock as of December 31, 2016, and changes during the year then ended, is presented below:
During 2016, 2015 and 2014, 66,000, 333,250 and 216,250 shares, respectively, of restricted stock vested with aggregate vesting date fair values of $63,000, $511,000 and $387,000, respectively.
In February 2016, 100,000 shares of restricted stock held by an executive officer with an aggregate fair value of $96,000 were forfeited in connection with his separation from employment. During 2016, 66,000 shares of restricted stock held by non-employee directors with an aggregate fair value of $63,000 vested as scheduled according to the terms of the restricted stock agreements. Also during 2016, 106,000 shares of restricted stock held by non-employee directors with an aggregate fair value of $118,000 were forfeited as a result of their departures from the Board.
During 2015, 120,000 shares of restricted stock held by non-employee directors with an aggregate fair value of $193,000 vested as scheduled according to the terms of the restricted stock agreements. Also during 2015, 193,250 shares of restricted stock held by employees with an aggregate fair value of $286,000 vested as scheduled according to the terms of the restricted stock agreements. During 2015, 27,000 shares of restricted stock held by employees with an aggregate fair value of $50,000 were forfeited in connection with their separation from employment. In April 2015, 20,000 shares of restricted stock held by an executive officer with an aggregate fair value of $32,000 vested upon reaching a milestone as defined by the terms of the restricted stock agreement. In May 2015, 20,000 shares of restricted stock held by an executive officer with an aggregate fair value of $25,000 were forfeited in connection with his separation from employment. In July 2015, 61,000 shares of restricted stock held by non-employee directors with an aggregate fair value of $107,000 were forfeited as a result of their departures from the Board.
During 2014, 61,250 shares of restricted stock held by non-employee directors with an aggregate fair value of $111,000 vested as scheduled according to the terms of the restricted stock agreements. Also during 2014, 40,000 shares of restricted stock held by executive officers with an aggregate fair value of $52,000 vested upon reaching certain milestones as defined by the terms of the restricted stock agreements. In March 2014, 100,000 shares of restricted stock with an aggregate fair value of $205,000 vested as scheduled according to the terms of the restricted stock agreement. In May 2014, 175,000 shares of restricted stock held by our former CEO with an aggregate fair value of $278,000 were forfeited in connection with his separation from employment. In September 2014, 125,000 shares of restricted stock held by our former CEO with an aggregate fair value of $166,000 were forfeited in connection with termination of his Consulting Agreement. In December 2014, 15,000 shares of restricted stock held by our former CEO with an aggregate fair value of $19,000 vested as scheduled in accordance with the terms of the restricted stock agreement.
During 2015 and 2014, we paid minimum tax withholdings related to stock options exercised and restricted stock vested of $24,000 and $131,000, respectively. No such tax withholdings were paid related to stock options exercised or restricted stock vested during 2016. As of December 31, 2016, there was approximately $223,000 of total unrecognized compensation cost related to stock option and restricted stock awards, which we expect to recognize over remaining weighted average vesting terms of 1.2 years. See Note 1(e).
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Earnings Per Share |
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Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share | Basic (loss) earnings per share is calculated by dividing net (loss) income attributable to common stockholders by the weighted-average number of common shares and, except for periods with a loss from operations, participating securities outstanding during the period. Diluted (loss) earnings per share reflects additional common shares that would have been outstanding if dilutive potential common shares had been issued. Potential common shares that may be issued by the Company include convertible debt, convertible preferred stock, options and warrants.
The following table sets forth the calculation of basic and diluted (loss) earnings per share for the years ended December 31, 2016, 2015 and 2014:
Diluted (loss) earnings per common share for the years ended December 31, 2016, 2015 and 2014 excludes the effects of 14.1 million, 14.6 million and 19.0 million common share equivalents, respectively, since such inclusion would be anti-dilutive. The excluded shares consist of common shares issuable upon exercise of outstanding stock options and warrants, and upon the conversion of convertible debt and convertible preferred stock.
The Company’s unvested stock awards contain nonforfeitable rights to dividends or dividend equivalents, whether paid or unpaid (referred to as “participating securities”). Therefore, the unvested stock awards are required to be included in the number of shares outstanding for both basic and diluted earnings per share calculations. However, due to our loss from continuing operations, 207,000, 361,000 and 498,250 shares of unvested restricted stock for the years ended December 31, 2016, 2015 and 2014, respectively, were excluded in determining basic and diluted loss per share because such inclusion would be anti-dilutive.
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Accounts and Other Receivables and Concentrations of Credit Risk |
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Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||
Accounts and Other Receivables and Concentrations of Credit Risk | Accounts and other receivables at December 31, 2016 and 2015 consist of the following:
At December 31, 2016 and 2015, approximately 89% and 67%, respectively, of net accounts and other receivables were due from Cardinal Health 414. In addition, at December 31, 2015, approximately 32% of net accounts and other receivables were due from Devicor related to royalty amounts earned based on 2015 GDS Business revenue. As of December 31, 2016 and 2015, there was no allowance for doubtful accounts. We do not believe we are exposed to significant credit risk related to Cardinal Health 414 or Devicor based on the overall financial strength and credit worthiness of the entities. We believe that we have adequately addressed other credit risks in estimating the allowance for doubtful accounts.
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Inventory |
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Inventory | The components of net inventory at December 31, 2016 and 2015, net of reserves of $0 and $345,000, respectively, are as follows:
During 2016 and 2015, we utilized $131,000 and $446,000, respectively, of Tc 99m tilmanocept inventory for clinical study and product development purposes. Also during 2016 and 2015, we recorded obsolescence reserves of $43,000 and $52,000 of Tc 99m tilmanocept inventory related to specific lots that expired or were nearing product expiry and therefore were no longer expected to be sold. During 2016 and 2015, we wrote off $0 and $120,000, respectively, of materials related to production issues.
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Property and Equipment |
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Property, Plant and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment | The major classes of property and equipment are as follows:
* We amortize leasehold improvements over the term of the lease, which in all cases is shorter than the estimated useful life of the asset.
Property and equipment includes $9,000 of equipment under capital leases with accumulated amortization of $7,000 at December 31, 2015. No property or equipment was under capital lease at December 31, 2016. During 2016, 2015 and 2014, we recorded $496,000, $562,000 and $488,000, respectively, of depreciation and amortization related to property and equipment.
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Investment in Macrophage Therapeutics, Inc. |
12 Months Ended |
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Dec. 31, 2016 | |
Investments in and Advances to Affiliates, Schedule of Investments [Abstract] | |
Investment in Macrophage Therapeutics, Inc. | In March 2015, MT, our previously wholly-owned subsidiary, entered into a Securities Purchase Agreement to sell up to 50 shares of its Series A Convertible Preferred Stock (“MT Preferred Stock”) and warrants to purchase up to 1,500 common shares of MT (“MT Common Stock”) to Platinum and Dr. Michael Goldberg (collectively, the “MT Investors”) for a purchase price of $50,000 per unit. A unit consists of one share of MT Preferred Stock and 30 warrants to purchase MT Common Stock. Under the agreement, 40% of the MT Preferred Stock and warrants are committed to be purchased by Dr. Goldberg, and the balance by Platinum. The full 50 shares of MT Preferred Stock and warrants that may be sold under the agreement are convertible into, and exercisable for, MT Common Stock representing an aggregate 1% interest on a fully converted and exercised basis. Navidea owns the remainder of the MT Common Stock. On March 11, 2015, definitive agreements with the MT Investors were signed for the sale of the first 10 shares of MT Preferred Stock and warrants to purchase 300 shares of MT Common Stock to the MT Investors, with gross proceeds to MT of $500,000. The MT Common Stock held by parties other than Navidea is reflected on the consolidated balance sheets as a noncontrolling interest.
The warrants have certain characteristics including a net settlement provision that require the warrants to be accounted for as a derivative liability at fair value, with subsequent changes in fair value included in earnings. The fair value of the warrants was estimated to be $63,000 at issuance and at December 31, 2015. See Notes 1(m) and 3. In addition, the MT Preferred Stock was immediately available for conversion upon issuance and includes a beneficial conversion feature, resulting in a deemed dividend of $46,000 related to the beneficial conversion feature. Finally, certain provisions of the Securities Purchase Agreement obligate the MT Investors to acquire the remaining MT Preferred Stock and related warrants for $2.0 million at the option of MT. The estimated relative fair value of this put option was $113,000 at issuance based on the Black-Scholes option pricing model and is classified within stockholders' equity.
In addition, we entered into a Securities Exchange Agreement with the MT Investors providing them an option to exchange their MT Preferred Stock for our common stock in the event that MT has not completed a public offering with gross proceeds to MT of at least $50 million by the second anniversary of the closing of the initial sale of MT Preferred Stock, at an exchange rate per share obtained by dividing $50,000 by the greater of (i) 80% of the twenty-day volume weighted average price per share of our common stock on the second anniversary of the initial closing or (ii) $3.00. To the extent that the MT Investors do not timely exercise their exchange right, MT has the right to redeem their MT Preferred Stock for a price equal to $58,320 per share. We also granted MT an exclusive license for certain therapeutic applications of the Manocept technology.
In December 2015 and May 2016, Platinum contributed a total of $200,000 to MT. MT was not obligated to provide anything in return, although it was considered likely that the MT Board would ultimately authorize some form of compensation to Platinum. During the year ended December 31, 2016, the Company recorded the entire $200,000 as a current liability pending determination of the form of compensation.
In July 2016, MT’s Board of Directors authorized modification of the original investments of $300,000 by Platinum and $200,000 by Dr. Goldberg to a convertible preferred stock with a 10% paid-in-kind (“PIK”) coupon retroactive to the time the initial investments were made. The conversion price of the preferred will remain at the $500 million initial market cap but a full ratchet was added to enable the adjustment of conversion price, warrant number and exercise price based on the valuation of the first institutional investment round. In addition, the MT Board authorized issuance of additional convertible preferred stock with the same terms to Platinum as compensation for the additional $200,000 of investments made in December 2015 and May 2016. As of the date of filing of this Form 10-K, final documents related to the above transactions authorized by the MT Board have not been completed. |
Investment in R-NAV, LLC |
12 Months Ended |
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Dec. 31, 2016 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Investment in R-NAV, LLC | In July 2014, Navidea formed a joint enterprise with Essex Woodlands-backed Rheumco, LLC, to develop and commercialize radiolabeled diagnostic and therapeutic products for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, LLC, combined Navidea’s proprietary Manocept CD206 macrophage targeting platform and Rheumco’s proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need, including the detection and treatment of RA and veterinary osteoarthritis.
Both Rheumco and Navidea contributed licenses for intellectual property and technology to R-NAV in exchange for common units in R-NAV. The contributions of these licenses were recorded using the carryover basis. R-NAV was initially capitalized through a $4.0 million investment from third-party private investors, and the technology contributions from Rheumco and Navidea. Navidea committed an additional $1.0 million investment to be paid over three years, with $333,334 in cash contributed at inception and a promissory note in the principal amount of $666,666, payable in two equal installments on the first and second anniversaries of the transaction. A principal payment of $333,333 was made on the note payable to R-NAV in July 2015. In exchange for its capital and in-kind investment, the Company received 3,500,000 Common Units and 1,000,000 Series A preferred units of R-NAV (“Series A Units”). The Company was to receive an additional 500,000 Series A Units for management and technical services associated with the programs described above performed by the Company for R-NAV pursuant to a services agreement.
Navidea initially owned approximately 33.7% of the combined entity. At December 31, 2015, Navidea owned approximately 27.3% of R-NAV. Joint oversight over certain aspects of R-NAV was shared between Navidea and the other investors; Navidea did not control the operations of R-NAV. Navidea had three-year call options to acquire, at its sole discretion, all of the equity of R-NAV’s TcRA Imaging, Inc. subsidiary (“TcRA”) for $10.5 million prior to the launch of a Phase 3 clinical trial for its development program, and all of the equity of R-NAV’s SnRA Theragnostics, Inc. subsidiary at fair value upon completion of radiochemistry and biodistribution studies for its development program.
Effective May 31, 2016, Navidea terminated its joint venture with R-NAV. Under the terms of the agreement, Navidea (1) transferred all of its shares of R-NAV, consisting of 1,500,000 Series A Preferred Units and 3,500,000 Common Units, to R-NAV; and (2) paid $110,000 in cash to R-NAV. In exchange, R-NAV (1) transferred all of its shares of TcRA to Navidea, thereby returning the technology licensed to TcRA to Navidea; and (2) forgave the $333,333 remaining on the promissory note. Neither Navidea nor R-NAV has any further obligations of any kind to either party. As a result of this transaction, the Company recognized a loss on disposal of the investment in R-NAV of $39,732 during 2016.
Navidea’s investment in R-NAV was being accounted for using the equity method of accounting. In accordance with current accounting guidance, the Company's initial contributions of cash and note payable totaling $1.0 million were allocated between the investment in R-NAV and the call option on TcRA based on the relative fair values of the assets. As a result, we recorded an initial equity investment in R-NAV of $727,000 and a call option asset of $273,000 as non-current assets at the time of the initial investment. Navidea's equity in the loss of R-NAV was $15,159, $305,253 and $523,809 for the years ended December 31, 2016, 2015 and 2014, respectively. Navidea’s equity in the loss of R-NAV exceeded our initial investment in R-NAV. As such, the carrying value of the Company’s investment in R-NAV was $0 as of May 31, 2016.
The Company’s obligation to provide $500,000 of in-kind services to R-NAV was being recognized as those services were provided. The Company provided $15,000, $64,000 and $39,000 of in-kind services during the years ended December 31, 2016, 2015 and 2014, respectively. As of May 31, 2016, the Company had $383,000 of in-kind services remaining to provide under this obligation. This obligation ceased on May 31, 2016 under the terms of the agreement.
Navidea provided additional services to R-NAV in support of its development activities. Such services were immaterial to Navidea’s overall operations. See Note 12. |
Accounts Payable, Accrued Liabilities and Other |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Accrued Liabilities and Other Liabilities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounts Payable, Accrued Liabilities and Other |
Accounts payable at December 31, 2016 and 2015 includes an aggregate of $116,000 and $7,000, respectively, due to related parties related to director fees and MT scientific advisory board fees.
Accrued liabilities and other, including an aggregate of $106,000 and $83,000 due to related parties related to director fees and MT scientific advisory board fees, at December 31, 2016 and 2015, respectively, consist of the following:
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Notes Payable |
12 Months Ended |
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Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Notes Payable |
Platinum
In July 2012, we entered into an agreement with Platinum to provide us with a credit facility of up to $50 million. Following the approval of Tc 99m tilmanocept, Platinum was committed under the terms of the agreement to extend up to $35 million in debt financing to the Company. The agreement also provided for Platinum to extend an additional $15 million on terms to be negotiated. Through June 25, 2013, we drew a total of $8.0 million under the original facility.
In June 2013, in connection with entering into the GECC/MidCap Loan Agreement (discussed below), the Company and Platinum entered into an Amendment to the Platinum Loan Agreement (the “First Platinum Amendment”). Concurrent with the execution of the First Platinum Amendment, the Company delivered an Amended and Restated Promissory Note (the “First Amended Platinum Note”) to Platinum, which amended and restated the original promissory note issued to Platinum, in the principal amount of up to $35 million. The First Amended Platinum Note also adjusted the interest rate to the greater of (a) the U.S. Prime Rate as reported in the Wall Street Journal plus 6.75%; (b) 10%; or (c) the highest rate of interest then payable pursuant to the GECC/MidCap Loan Agreement plus 0.125%. In addition, the First Platinum Amendment granted Platinum the right, at Platinum’s option subject to certain conditions, to convert all or any portion of the unpaid principal or unpaid interest accrued on any future draw (the “Conversion Amount”), beginning on a date two years from the date the draw is advanced, into the number of shares of Navidea’s common stock computed by dividing the Conversion Amount by a conversion price equal to the lesser of (i) 90% of the lowest VWAP for the 10 trading days preceding the date of such conversion request, or (ii) the average VWAP for the 10 trading days preceding the date of such conversion request. The First Platinum Amendment also provided a conversion right on the same terms with respect to the amount of any mandatory repayment due following the Company achieving $2.0 million in cumulative revenues from sales or licensing of Tc 99m tilmanocept. Platinum’s option to convert future draws into common stock was determined to meet the definition of a liability. The estimated fair value of the embedded conversion option is included in the carrying value of the new debt.
Also in connection with the First Platinum Amendment, the Company and Platinum entered into a Warrant Exercise Agreement (“Exercise Agreement”), pursuant to which Platinum exercised its Series X Warrant and Series AA Warrant. The warrants were exercised on a cashless basis by canceling a portion of the indebtedness outstanding under the Platinum Loan Agreement equal to $4.8 million, the aggregate exercise price of the warrants. Pursuant to the Exercise Agreement, in lieu of common stock, Platinum received on exercise of the warrants 2,364.9 shares of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), convertible into 7,733,223 shares of our common stock in the aggregate (3,270 shares of common stock per preferred share).
In March 2014, in connection with entering into the Oxford Loan Agreement (discussed below), we repaid all amounts outstanding under the GECC/MidCap Loan agreement and entered into a second amendment to the Platinum Loan Agreement (the “Second Platinum Amendment”). Concurrent with the execution of the Second Platinum Amendment, the Company delivered an Amended and Restated Promissory Note (the “Second Amended Platinum Note”) to Platinum, which amended and restated the First Amended Platinum Note. The Second Amended Platinum Note adjusted the interest rate to the greater of (i) the United States prime rate as reported in The Wall Street Journal plus 6.75%, (ii) 10.0%, and (iii) the highest rate of interest then payable by the Company pursuant to the Oxford Loan Agreement plus 0.125%.
In May 2015, in connection with the execution of the CRG Loan Agreement (discussed below), the Company amended the existing Platinum credit facility to allow this facility to remain in place in a subordinated role to the CRG Loan (the “Third Platinum Amendment”). Among other things, the Third Platinum Amendment (i) extended the term of the Platinum Loan Agreement until a date six months following the maturity date or earlier repayment of the CRG Term Loan; (ii) changes the interest rate to the greater of (a) the United States prime rate as reported in The Wall Street Journal plus 6.75%, (b) 10.0% and (c) the highest rate of interest then payable pursuant to the CRG Term Loan plus 0.125%; (iii) requires such interest to compound monthly; and (iv) changes the provisions of the Platinum Loan Agreement governing Platinum’s right to convert advances into common stock of the Company. The Third Platinum Amendment provides for the conversion of all principal and interest outstanding under the Platinum Loan Agreement, but not until such time as the average daily volume weighted average price of the Company’s common stock for the ten preceding trading days exceeds $2.53 per share. The Third Platinum Amendment became effective upon initial funding of the CRG Loan Agreement.
The Platinum Note is reflected on the consolidated balance sheets at its estimated fair value, which includes the estimated fair value of the embedded conversion option of $153,000 at December 31, 2016. During the years ended December 31, 2016, 2015 and 2014, changes in the estimated fair value of the Platinum debt liability were a decrease of $2.9 million, an increase of $615,000 and an increase of $1.3 million, respectively, and were recorded as non-cash changes in the fair value of financial instruments. The estimated fair value of the Platinum Note was $9.6 million and $11.5 million as of December 31, 2016 and 2015, respectively.
The Platinum Loan Agreement carries standard non-financial covenants typical for commercial loan agreements, many of which are similar to those contained in the CRG Loan Agreement, that impose significant requirements on us. Our ability to comply with these provisions may be affected by changes in our business condition or results of our operations, or other events beyond our control. The breach of any of these covenants would result in a default under the Platinum Loan Agreement, permitting Platinum to terminate our ability to obtain additional draws under the Platinum Loan Agreement and accelerate the maturity of the debt, subject to the limitations of the Subordination Agreement with CRG. Such actions by Platinum could materially adversely affect our operations, results of operations and financial condition, including causing us to substantially curtail our product development activities. The Platinum Loan Agreement includes a covenant that results in an event of default on the Platinum Loan Agreement upon default on the CRG Loan Agreement. As discussed below, the Company is maintaining its position that CRG’s alleged claims do not constitute events of default under the CRG Loan Agreement and believes it has defenses against such claims. The Company has obtained a waiver from Platinum confirming that we are not in default under the Platinum Loan Agreement as a result of the alleged default on the CRG Loan Agreement and as such, we are currently in compliance with all covenants under the Platinum Loan Agreement.
The Platinum Loan Agreement, as amended, provides us with a credit facility of up to $50 million. We drew a total of $4.5 million and $4.0 million under the credit facility in each of the years ended December 31, 2015 and 2013. We did not make any draws under the credit facility during the years ended December 31, 2016 and 2014. In addition, $1.0 million and $761,000 of interest was compounded and added to the balance of the Platinum Note during the years ended December 31, 2016 and 2015, respectively. In accordance with the terms of a Section 16(b) Settlement Agreement, Platinum agreed to forgive interest owed on the credit facility in an amount equal to 6%, effective July 1, 2016. As of December 31, 2016, the remaining outstanding principal balance of the Platinum Note was approximately $9.5 million, consisting of $7.7 million of draws and $1.8 million of compounded interest, with $27.3 million still available under the credit facility. An additional $15 million is potentially available under the credit facility on terms to be negotiated. However, based on Platinum’s recent filing for Chapter 15 bankruptcy protection, Navidea has substantial doubt about Platinum’s ability to fund future draw requests under the credit facility.
In connection with the closing of the Asset Sale to Cardinal Health 414 in March 2017, the Company repaid to PPCO an aggregate of approximately $7.7 million in partial satisfaction of the Company’s liabilities, obligations and indebtedness under the Platinum Loan Agreement between the Company and Platinum-Montaur, which, to the extent of such payment, were transferred by Platinum-Montaur to PPCO. The Company was informed by PPVA that it was the owner of the balance of the Platinum-Montaur loan. Such balance of approximately $1.9 million was due upon closing of the Asset Sale but withheld by the Company and not paid to anyone as it is subject to competing claims of ownership by both Dr. Michael Goldberg, the Company’s President and Chief Executive Officer, and PPVA.
Capital Royalty Partners II, L.P.
In May 2015, Navidea and MT, as guarantor, executed a Term Loan Agreement (the “CRG Loan Agreement”) with Capital Royalty Partners II L.P. (“CRG”) in its capacity as a lender and as control agent for other affiliated lenders party to the CRG Loan Agreement (collectively, the “Lenders”) in which the Lenders agreed to make a term loan to the Company in the aggregate principal amount of $50 million (the “CRG Term Loan”), with an additional $10 million in loans to be made available upon the satisfaction of certain conditions stated in the CRG Loan Agreement. Closing and funding of the CRG Term Loan occurred on May 15, 2015 (the “Effective Date”). The principal balance of the CRG Term Loan bore interest from the Effective Date at a per annum rate of interest equal to 14.0%. Through March 31, 2019, the Company had the option of paying (i) 10.00% of the per annum interest in cash and (ii) 4.00% of the per annum interest as compounded interest which is added to the aggregate principal amount of the CRG Term Loan. During 2016 and 2015, $553,000 and $1.3 million of interest was compounded and added to the balance of the CRG Term Loan. In addition, the Company began paying the cash portion of the interest in arrears on June 30, 2015. Principal was due in eight equal quarterly installments during the final two years of the term. All unpaid principal, and accrued and unpaid interest, was due and payable in full on March 31, 2021.
Pursuant to a notice of default letter sent to Navidea by CRG in April 2016, the Company stopped compounding interest in the second quarter of 2016 and began recording accrued interest. As of December 31, 2016 and 2015, $5.8 million and $0, respectively, of accrued interest related to the CRG Term Loan is included in accrued liabilities and other on the consolidated balance sheets. As of December 31, 2016 and 2015, the outstanding principal balance of the CRG Term Loan was $51.7 million and $51.3 million, respectively.
In connection with the CRG Loan Agreement, the Company recorded a debt discount related to lender fees and other costs directly attributable to the CRG Loan Agreement totaling $2.2 million, including a $1.0 million facility fee which is payable at the end of the term or when the loan is repaid in full. A long-term liability was recorded for the $1.0 million facility fee. The debt discount was being amortized as non-cash interest expense using the effective interest method over the term of the CRG Loan Agreement. As further described below, the facility fee was fully paid off and the debt discount was accelerated and fully amortized in the second quarter of 2016.
The CRG Term Loan was collateralized by a security interest in substantially all of the Company's assets. In addition, the CRG Loan Agreement required that the Company adhere to certain affirmative and negative covenants, including financial reporting requirements and a prohibition against the incurrence of indebtedness, or creation of additional liens, other than as specifically permitted by the terms of the CRG Loan Agreement. The Lenders could accelerate the payment terms of the CRG Loan Agreement upon the occurrence of certain events of default set forth therein, which include the failure of the Company to make timely payments of amounts due under the CRG Loan Agreement, the failure of the Company to adhere to the covenants set forth in the CRG Loan Agreement, and the insolvency of the Company. The covenants of the CRG Loan Agreement included a covenant that the Company shall have EBITDA of no less than $5 million in each calendar year during the term or revenues from sales of Tc 99m tilmanocept in each calendar year during the term of at least $22.5 million in 2016, with the target minimum revenue increasing in each year thereafter until reaching $45 million in 2020. However, if the Company were to fail to meet the applicable minimum EBITDA or revenue target in any calendar year, the CRG Loan Agreement provided the Company a cure right if it raised 2.5 times the EBITDA or revenue shortfall in equity or subordinated debt and deposited such funds in a separate blocked account. Additionally, the Company was required to maintain liquidity, defined as the balance of unencumbered cash and permitted cash equivalent investments, of at least $5 million during the term of the CRG Term Loan. The events of default under the CRG Loan Agreement also included a failure of Platinum to perform its funding obligations under the Platinum Loan Agreement at any time as to which the Company had negative EBITDA for the most recent fiscal quarter, as a result either of Platinum’s repudiation of its obligations under the Platinum Loan Agreement, or the occurrence of an insolvency event with respect to Platinum. An event of default would entitle CRG to accelerate the maturity of our indebtedness, increase the interest rate from 14% to the default rate of 18% per annum, and invoke other remedies available to it under the loan agreement and the related security agreement.
During the course of 2016, CRG alleged multiple claims of default on the CRG Loan Agreement, and filed suit in the District Court of Harris County, Texas. On June 22, 2016, CRG exercised control over one of the Company’s primary bank accounts and took possession of $4.1 million that was on deposit, applying $3.9 million of the cash to various fees, including collection fees, a prepayment premium and an end-of-term fee. The remaining $189,000 was applied to the principal balance of the debt. Multiple motions, actions and hearings followed over the remainder of 2016 and into 2017.
On March 3, 2017, the Company entered into a Global Settlement Agreement with MT, CRG, and Cardinal Health 414 to effectuate the terms of a settlement previously entered into by the parties on February 22, 2017. In accordance with the Global Settlement Agreement, on March 3, 2017, the Company repaid the $59 million Deposit Amount of its alleged indebtedness and other obligations outstanding under the CRG Term Loan. Concurrently with payment of the Deposit Amount, CRG released all liens and security interests granted under the CRG Loan Documents and the CRG Loan Documents were terminated and are of no further force or effect; provided, however, that, notwithstanding the foregoing, the Company and CRG agreed to continue with their proceeding pending in The District Court of Harris County, Texas to fully and finally determine the Final Payoff Amount. The Company and CRG further agreed that the Final Payoff Amount would be no less than $47 million and no more than $66 million. In addition, concurrently with the payment of the Deposit Amount and closing of the Asset Sale, (i) Cardinal Health 414 agreed to post a $7 million letter of credit in favor of CRG (at the Company’s cost and expense to be deducted from the closing proceeds due to the Company, and subject to Cardinal Health 414’s indemnification rights under the Purchase Agreement) as security for the amount by which the High Payoff Amount exceeds the Deposit Amount in the event the Company is unable to pay all or a portion of such amount, and (ii) CRG agreed to post a $12 million letter of credit in favor of the Company as security for the amount by which the Deposit Amount exceeds the Low Payoff Amount. If, on the one hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents exceeds the Deposit Amount, the Company will pay such excess amount, plus the costs incurred by CRG in obtaining CRG’s letter of credit, to CRG and if, on the other hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents is less than the Deposit Amount, CRG will pay such difference to the Company and reimburse Cardinal Health 414 for the costs incurred by Cardinal Health 414 in obtaining its letter of credit. Any payments owing to CRG arising from a final determination that the Final Payoff Amount is in excess of $59 million shall first be paid by the Company without resort to the letter of credit posted by Cardinal Health 414, and such letter of credit shall only be a secondary resource in the event of failure of the Company to make payment to CRG. The Company will indemnify Cardinal Health 414 for any costs it incurs in payment to CRG under the settlement, and the Company and Cardinal Health 414 further agree that Cardinal Health 414 can pursue all possible remedies, including offset against earnout payments (guaranteed or otherwise) under the Purchase Agreement, warrant exercise, or any other payments owed by Cardinal Health 414, or any of its affiliates, to the Company, or any of its affiliates, if Cardinal Health 414 incurs any cost associated with payment to CRG under the settlement. The Company and CRG also agreed that the $2 million being held in escrow pursuant to court order in the Ohio case and the $3 million being held in escrow pursuant to court order in the Texas case would be released to the Company at closing of the Asset Sale. On March 3, 2017, Cardinal Health 414 posted a $7 million letter of credit, and on March 7, 2017, CRG posted a $12 million letter of credit, each as required by the Global Settlement Agreement. The Texas hearing is currently set for July 3, 2017. See Notes 3, 13 and 24(b).
Oxford Finance, LLC
In March 2014, we executed a Loan and Security Agreement (the “Oxford Loan Agreement”) with Oxford Finance, LLC (“Oxford”), providing for a loan to the Company of $30 million. Pursuant to the Oxford Loan Agreement, we issued Oxford: (1) Term Notes in the aggregate principal amount of $30 million, bearing interest at 8.5% (the Oxford Notes), and (2) Series KK warrants to purchase an aggregate of 391,032 shares of our common stock at an exercise price of $1.918 per share, expiring in March 2021 (the “Series KK Warrants”). The Company recorded a debt discount related to the issuance of the Series KK Warrants and other fees to the lenders totaling $3.0 million. Debt issuance costs directly attributable to the Oxford Loan Agreement, totaling $120,000, were recorded as an additional debt discount on the consolidated balance sheet on the closing date. The debt discounts were being amortized as non-cash interest expense using the effective interest method over the term of the Oxford Loan Agreement. The final payment fee of $2.4 million was recorded in other non-current liabilities on the consolidated balance sheet on the closing date.
We began making monthly payments of interest only on April 1, 2014, and monthly payments of principal and interest beginning April 1, 2015. In May 2015, in connection with the consummation of the CRG Loan Agreement, the Company repaid all amounts outstanding under the Oxford Loan Agreement. The payoff amount of $31.7 million included payments of $289,000 as a pre-payment fee and $2.4 million as an end-of-term final payment fee. As of December 31, 2015, the Oxford Notes were no longer outstanding. The Series KK warrants remained outstanding as of December 31, 2016.
General Electric Capital Corporation/MidCap Financial SBIC, LP
In June 2013, we executed a Loan and Security Agreement (the “GECC/MidCap Loan Agreement”) with General Electric Capital Corporation (“GECC”) and MidCap Financial SBIC, LP (“MidCap”), pursuant to which we issued GECC and MidCap: (1) Term Notes in the aggregate principal amount of $25 million, bearing interest at 9.83%, (the “GECC/MidCap Notes”), and (2) Series HH warrants to purchase an aggregate of 301,205 shares of our common stock at an exercise price of $2.49 per share, expiring in June 2023 (the “Series HH Warrants”). The GECC/MidCap Loan Agreement provided for an interest-only period beginning on June 25, 2013 and expiring on June 30, 2014. The principal and interest was to be repaid in 30 equal monthly installments, payable on the first of each month following the expiration of the interest-only period, and one final payment in an amount equal to the entire remaining principal balance of the GECC/MidCap Notes on the maturity date. The outstanding balance of the debt was due December 23, 2016. On the date upon which the outstanding principal amount of the loan was paid in full, the Company was required to pay a non-refundable end-of-term fee equal to 4.0% of the original principal amount of the loan.
The Company recorded a debt discount related to the issuance of the Series HH Warrants and other fees to the lenders totaling $1.9 million. Debt issuance costs directly attributable to the GECC/MidCap Loan Agreement totaled $881,000. The debt discount and debt issuance costs were being amortized as non-cash interest expense using the effective interest method over the term of the GECC/MidCap Loan Agreement. The final payment fee of $1.0 million was recorded in other non-current liabilities on the consolidated balance sheet on the closing date.
In March 2014, in connection with the consummation of the Oxford Loan Agreement, we repaid all amounts outstanding under the GECC/MidCap Notes for a payoff amount of $26.7 million, which included payments of $500,000 as a pre-payment fee and $1.0 million as an end-of-term final payment fee, resulting in a loss on extinguishment of $2.6 million. As of December 31, 2014, the GECC/MidCap Notes were no longer outstanding. The Series HH Warrants remained outstanding as of December 31, 2016.
R-NAV, LLC
In July 2014, in connection with entering into the R-NAV joint enterprise, Navidea executed a promissory note in the principal amount of $666,666, payable in two equal installments on July 15, 2015 and July 15, 2016, the first and second anniversaries of the R-NAV transaction. The note bore interest at 0.31% per annum, compounded annually. A principal payment of $333,333 was made on the note payable to R-NAV in July 2015.
Effective May 31, 2016, Navidea terminated its joint venture with R-NAV. Under the terms of the agreement, Navidea (1) transferred all of its shares of R-NAV, consisting of 1,500,000 Series A Units and 3,500,000 Common Units, to R-NAV; and (2) paid $110,000 in cash to R-NAV. In exchange, R-NAV (1) transferred all of its shares of TcRA to Navidea, thereby returning the technology licensed to TcRA to Navidea; and (2) forgave the $333,333 remaining on the promissory note. Neither Navidea nor R-NAV has any further obligations of any kind to either party. See Note 10.
IPFS Corporation
In December 2016, we prepaid $348,000 of insurance premiums through the issuance of a note payable to IPFS Corporation (“IPFS”) with an interest rate of 8.99%. The note is payable in eight monthly installments of $45,000, with the final payment due on July 10, 2017. The note is included in notes payable, current in the December 31, 2016 consolidated balance sheet.
Summary
During the years ended December 31, 2016, 2015 and 2014, we recorded interest expense of $14.9 million, $6.9 million and $3.7 million, respectively, related to our notes payable. Of those amounts, $2.0 million, $493,000 and $844,000, respectively, was non-cash in nature related to amortization of the debt discounts and deferred financing costs related to our notes payable. An additional $1.6 million and $2.0 million, respectively, of this interest expense was compounded and added to the balance of our notes payable during the years ended December 31, 2016 and 2015.
Annual principal maturities of our notes payable are $52.0 million, $0, $0, $0, $9.5 million and $0 in 2017, 2018, 2019, 2020, 2021 and thereafter, respectively.
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Commitments and Contingencies |
12 Months Ended |
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Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies |
We are subject to legal proceedings and claims that arise in the ordinary course of business.
Section 16(b) Action
On August 12, 2015, a Navidea shareholder filed an action in the United States District Court for the Southern District of New York against two funds managed by Platinum alleging violations of Section 16(b) of the Securities Exchange Act of 1934, as amended, in connection with purchases and sales of the Company’s common stock by the Platinum funds, and seeking disgorgement of the short-swing profits realized by the funds (the “Litigation”). The Company was named as a nominal defendant in the Litigation.
The Litigation was resolved on the terms set forth in a settlement agreement (the “Settlement Agreement”). The Settlement Agreement was subject to a pending joint motion for approval. The Court approved the settlement on Friday, July 1, 2016. In accordance with the terms of the Settlement Agreement, the interest rate on the Platinum credit facility was reduced by 6% to 8.125% effective July 1, 2016. In addition, Platinum assumed the obligation to pay the legal costs associated with the Litigation.
Sinotau Litigation – NAV4694
On August 31, 2015, Hainan Sinotau Pharmaceutical Co., Ltd. (“Sinotau”) filed a suit for damages, specific performance, and injunctive relief against the Company in the United States District Court for the District of Massachusetts alleging breach of a letter of intent for licensing to Sinotau of the Company’s NAV4694 product candidate and technology. The Company believed the suit was without merit and filed a motion to dismiss the action. In September 2016, the Court denied the motion to dismiss. The Company filed its answer to the complaint and the case is currently in the discovery phase. At this time it is not possible to determine with any degree of certainty the ultimate outcome of this legal proceeding, including making a determination of liability. The Company intends to vigorously defend the case.
In July 2016, the Company executed a term sheet with Cerveau Technologies, Inc. (“Cerveau”) as a designated party for the rights resulting from the relationship between Navidea and Sinotau. The term sheet outlined the terms of a potential agreement between the parties to sublicense NAV4694 to Cerveau in return for license fees, milestone payments and royalties. With the exception of certain provisions, the term sheet was non-binding and was subject to the agreement of AstraZeneca, from whom the Company has licensed the NAV4694 technology. The Company had 60 days to execute a definitive agreement, however no definitive agreement was reached. Discussions related to the potential licensure or divestiture of NAV4694 are ongoing.
CRG Litigation
During the course of 2016, CRG alleged multiple claims of default on the CRG Loan Agreement, and filed suit in the District Court of Harris County, Texas. On June 22, 2016, CRG exercised control over one of the Company’s primary bank accounts and took possession of $4.1 million that was on deposit, applying $3.9 million of the cash to various fees, including collection fees, a prepayment premium and an end-of-term fee. The remaining $189,000 was applied to the principal balance of the debt. Multiple motions, actions and hearings followed over the remainder of 2016 and into 2017.
On March 3, 2017, the Company entered into a Global Settlement Agreement with MT, CRG, and Cardinal Health 414 to effectuate the terms of a settlement previously entered into by the parties on February 22, 2017. In accordance with the Global Settlement Agreement, on March 3, 2017, the Company repaid the $59 million Deposit Amount of its alleged indebtedness and other obligations outstanding under the CRG Term Loan. Concurrently with payment of the Deposit Amount, CRG released all liens and security interests granted under the CRG Loan Documents and the CRG Loan Documents were terminated and are of no further force or effect; provided, however, that, notwithstanding the foregoing, the Company and CRG agreed to continue with their proceeding pending in The District Court of Harris County, Texas to fully and finally determine the Final Payoff Amount. The Company and CRG further agreed that the Final Payoff Amount would be no less than $47 million and no more than $66 million. In addition, concurrently with the payment of the Deposit Amount and closing of the Asset Sale, (i) Cardinal Health 414 agreed to post a $7 million letter of credit in favor of CRG (at the Company’s cost and expense to be deducted from the closing proceeds due to the Company, and subject to Cardinal Health 414’s indemnification rights under the Purchase Agreement) as security for the amount by which the High Payoff Amount exceeds the Deposit Amount in the event the Company is unable to pay all or a portion of such amount, and (ii) CRG agreed to post a $12 million letter of credit in favor of the Company as security for the amount by which the Deposit Amount exceeds the Low Payoff Amount. If, on the one hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents exceeds the Deposit Amount, the Company will pay such excess amount, plus the costs incurred by CRG in obtaining CRG’s letter of credit, to CRG and if, on the other hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents is less than the Deposit Amount, CRG will pay such difference to the Company and reimburse Cardinal Health 414 for the costs incurred by Cardinal Health 414 in obtaining its letter of credit. Any payments owing to CRG arising from a final determination that the Final Payoff Amount is in excess of $59 million shall first be paid by the Company without resort to the letter of credit posted by Cardinal Health 414, and such letter of credit shall only be a secondary resource in the event of failure of the Company to make payment to CRG. The Company will indemnify Cardinal Health 414 for any costs it incurs in payment to CRG under the settlement, and the Company and Cardinal Health 414 further agree that Cardinal Health 414 can pursue all possible remedies, including offset against earnout payments (guaranteed or otherwise) under the Purchase Agreement, warrant exercise, or any other payments owed by Cardinal Health 414, or any of its affiliates, to the Company, or any of its affiliates, if Cardinal Health 414 incurs any cost associated with payment to CRG under the settlement. The Company and CRG also agreed that the $2 million being held in escrow pursuant to court order in the Ohio case and the $3 million being held in escrow pursuant to court order in the Texas case would be released to the Company at closing of the Asset Sale. On March 3, 2017, Cardinal Health 414 posted a $7 million letter of credit, and on March 7, 2017, CRG posted a $12 million letter of credit, each as required by the Global Settlement Agreement. The Texas hearing is currently set for July 3, 2017. See Notes 3, 12 and 24(b).
Former CEO Arbitration
On May 12, 2016 the Company received a demand for arbitration through the American Arbitration Association, Columbus, Ohio, from Ricardo J. Gonzalez, the Company’s then Chief Executive Officer, claiming that he was terminated without cause and, alternatively, that he resigned in accordance with Section 4G of his Employment Agreement pursuant to a notice received by the Company on May 9, 2016. On May 13, 2016, the Company notified Mr. Gonzalez that his failure to undertake responsibilities assigned to him by the Board of Directors and otherwise work after being ordered to do so on multiple occasions constituted an effective resignation, and the Company accepted that resignation. The Company rejected the resignation of Mr. Gonzalez pursuant to Section 4G of his Employment Agreement. Also, the Company notified Mr. Gonzalez that, alternatively, his failure to return to work after the expiration of the cure period provided in his Employment Agreement constituted cause for his termination under his Employment Agreement. Mr. Gonzalez is seeking severance and other amounts claimed to be owed to him under his Employment Agreement. In addition, the Company filed counterclaims against Mr. Gonzalez alleging malfeasance by Mr. Gonzalez in his role as Chief Executive Officer. Mr. Gonzalez has withdrawn his claim for additional severance pursuant to Section 4G of his Employment Agreement, and the Company has withdrawn its counterclaims. Mr. Gonzalez has made settlement demands but the Company has made no counteroffers to date. A three-person arbitration board has been chosen and a hearing is set for April 3-7, 2017 in Columbus, Ohio.
Former Director Litigation
On August 12, 2016, the Company commenced an action in the Superior Court of California for damages and injunctive relief against former Navidea Chairman and MT Board Member Anton Gueth. The Complaint alleges, in part, that Mr. Gueth intentionally failed to disclose his prior existing relationship with CRG, in addition to multiple breaches including duty, loyalty and contract, interference and misappropriation. The litigation was dismissed without prejudice on December 19, 2016.
FTI Consulting, Inc. Litigation
On October 11, 2016, FTI Consulting, Inc. (“FTI”) commenced an action against the Company in the Supreme Court of the State of New York, County of New York, seeking damages in excess of $782,600 comprised of: (i) $730,264 for investigative and consulting services FTI alleges to have provided to the Company pursuant to an Engagement Agreement, and (ii) in excess of $52,337 for purported interest due on unpaid invoices, plus attorneys’ fees, costs and expenses. On November 14, 2016, the Company filed an Answer and Counterclaim denying the allegations of the Complaint and seeking damages on its Counterclaim, in an amount to be determined at trial, for intentional overbilling by FTI. On February 7, 2017, a preliminary conference was held by the Court at which time a scheduling order governing discovery was issued. The Court set August 31, 2017 as the deadline for FTI to file a Note of Issue and Certificate of Readiness for trial. Discovery will commence within the next few weeks. The Company intends to vigorously defend the action.
Sinotau Litigation – Tc 99m Tilmanocept
On February 1, 2017, Navidea filed suit against Sinotau in the U.S. District Court for the Southern District of Ohio. The Company's complaint included claims seeking a declaration of the rights and obligations of the parties to an agreement regarding rights for the Tc 99m tilmanocept product in China and other claims. The complaint sought a temporary restraining order ("TRO") and preliminary injunction to prevent Sinotau from interfering with the Company’s Asset Sale to Cardinal Health 414. On February 3, 2017, the Court granted the TRO and extended it until March 6, 2017. The Asset Sale closed on March 3, 2017. On March 6, the Court dissolved the TRO as moot. The Ohio case remains open because all issues raised in the complaint have not been resolved.
Sinotau also filed a suit against the Company and Cardinal Health 414 in the U.S. District Court for the District of Delaware on February 2, 2017. On February 18, 2017, the Company and Cardinal Health 414 moved to stay the case pending the outcome of the Ohio case. The Court granted the motion on March 1, 2017, and the stay remains in effect.
In accordance with ASC Topic 450, Contingencies, we make a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Although the outcome of any litigation is uncertain, in our opinion, the amount of ultimate liability, if any, with respect to these actions will not materially affect our financial position.
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Preferred Stock |
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Dec. 31, 2016 | |
Equity [Abstract] | |
Preferred Stock | As discussed in Note 12, in June 2013, the Company and Platinum entered into a Warrant Exercise Agreement, pursuant to which Platinum exercised its Series X warrant and Series AA warrant for 2,364.9 shares of the Company's Series B Preferred Stock, convertible into 7,733,223 shares of our common stock in the aggregate.
During 2013, Platinum converted 1,737.9 shares of the Series B Preferred Stock into 5,682,933 shares of our common stock under the terms of the Series B Preferred Stock. During 2014, Platinum converted 4,422 shares of the Series B Preferred Stock into 14,459,940 shares of our common stock under the terms of the Series B Preferred Stock. In November 2014, we entered into a second Securities Exchange Agreement with Platinum, pursuant to which Platinum exchanged 4,499,520 shares of our common stock owned by Platinum for 1,376 shares of our Series B Preferred Stock.
In August 2015, we entered into a Securities Exchange Agreement with two investment funds managed by Platinum to exchange the 4,519 shares of Series B Preferred Stock held by them for twenty-year warrants to purchase common stock of the Company (the “Series LL Warrants”). The Series B Preferred Stock was convertible into common stock at a conversion rate of 3,270 shares of common stock per share of Series B Preferred Stock resulting in an aggregate number of shares of common stock into which the Series B Preferred Stock was convertible of 14,777,130 shares. The exercise price of the Series LL Warrants is $0.01 per share, and the total number of shares of common stock for which the Series LL Warrants are exercisable is 14,777,130 shares. The Series LL Warrants contain cashless exercise provisions, and the other economic terms are comparable to those of the Series B Preferred Stock, except that there is no liquidation preference associated with the Series LL Warrants or shares issuable on the exercise thereof. The Securities Exchange Agreement also contains certain provisions that prohibit the payment of dividends, distributions of common stock or issuances of common stock at effective prices less than $1.35. There was no other consideration paid or received for the exchange. No gain or loss was recognized in our consolidated financial statements as a result of the exchange. The exchange transaction was entered into in connection with the filing of an application to list the Company’s common stock on the Tel Aviv Stock Exchange (“TASE”) in order to comply with a listing requirement of the TASE requiring that listed companies have only one class of equity securities issued and outstanding. Following the exchange, the Company has no shares of preferred stock outstanding.
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Equity Instruments |
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Equity Instruments | a. Stock Warrants: At December 31, 2016, there are 11.3 million warrants outstanding to purchase our common stock. The warrants are exercisable at prices ranging from $0.01 to $3.04 per share with a weighted average exercise price per share of $0.33. See Note 24(d).
The following table summarizes information about our outstanding warrants at December 31, 2016:
* Weighted average exercise price.
In addition, at December 31, 2016, there are 300 warrants outstanding to purchase MT Common Stock. The warrants are exercisable at $2,000 per share.
In March 2014, in connection with the Oxford Loan Agreement, the Company issued Series KK Warrants to purchase an aggregate of 391,032 shares of our common stock at an exercise price of $1.918 per share, expiring in March 2021.
In November 2014, an outside investor exchanged their Series JJ warrants for 3,843,223 shares of our common stock in accordance with the terms of the Series JJ warrant agreement. As a result of the exchange of the Series JJ warrants, we reclassified $7.7 million in derivative liabilities related to those warrants to additional paid-in capital.
In July 2015, we extended the expiration date of our outstanding Series BB warrants by three years to July 2018. The modification of the Series BB warrant expiry resulted in recording a non-cash selling, general and administrative expense of approximately $150,000 during the third quarter of 2015.
In September 2015, we issued four-year Series MM warrants to purchase 150,000 shares of our common stock at an exercise price of $2.50 per share pursuant to an advisory services agreement with Chardan Capital Markets, LLC (“Chardan”). In October 2015, we issued additional four-year Series MM warrants to purchase 150,000 shares of our common stock at an exercise price of $2.50 per share pursuant to the advisory services agreement with Chardan. The fair value of the warrants issued to Chardan of $256,000 was recorded as a non-cash selling, general and administrative expense during the third quarter of 2015.
In October 2015, 5,000,000 Series LL Warrants were exercised on a cashless basis in exchange for the issuance of 4,977,679 shares of our common stock.
b. Common Stock Reserved: As of December 31, 2016, we have reserved 18,641,776 shares of authorized common stock for the exercise of all outstanding stock options and warrants, and upon the conversion of convertible debt and convertible preferred stock.
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Reductions in Force |
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Dec. 31, 2016 | |
Restructuring and Related Activities [Abstract] | |
Reductions in Force |
In May 2014, the Company’s Board of Directors made the decision to refocus the Company's resources to better align the funding of our pipeline programs with the expected growth in Tc 99m tilmanocept revenue. As a part of the realignment, the Company terminated a total of 11 employees, including the Chief Executive Officer, Dr. Mark J. Pykett.
Effective May 30, 2014, the Company and Dr. Pykett entered into a Separation Agreement and Release. Following the termination date, Dr. Pykett was entitled to receive a $750,000 severance payment, payable in two equal installments on June 9, 2014, and January 2, 2015, respectively; a single payment for accrued vacation and personal days; and reimbursement for certain other expenses and fees. Certain of Dr. Pykett's equity awards terminated upon separation, while others were modified in conjunction with the Separation Agreement and the Consulting Agreement described below.
Effective June 1, 2014, the Company and Dr. Pykett entered into a Consulting Agreement pursuant to which Dr. Pykett was to serve as an independent consultant to the Company until December 31, 2014 with respect to clinical-regulatory activities, commercial activities, program management, and business development, among other services. Dr. Pykett was entitled to a consulting fee of $27,500 per month plus reimbursement of reasonable expenses. The Consulting Agreement also provided for a grant of 40,000 shares of restricted stock which were to vest upon certain service and performance conditions.
Dr. Pykett terminated the Consulting Agreement effective September 8, 2014. Certain of Dr. Pykett's equity awards were forfeited upon termination of the Consulting Agreement, while others vested on December 1, 2014 due to achievement of certain goals during the period of the Consulting Agreement, in accordance with the terms of the award agreements. The Company recognized expenses of $94,000 under the Consulting Agreement during the year ended December 31, 2014.
During the year ended December 31, 2014, the Company recognized approximately $557,000 of net expense as a result of the reduction in force, which included separation costs, incremental expense related to the modification of certain equity awards, and the reversal of stock compensation expense for certain equity awards for which the requisite service was not rendered.
The Company appointed Michael M. Goldberg, M.D., as interim Chief Executive Officer effective May 30, 2014. Dr. Goldberg then served as a member of the Board of Directors of the Company and did not receive any salary for his service as interim Chief Executive Officer, although the Company agreed to pay Montaur Capital Partners, LLC (“Montaur”), where Dr. Goldberg was principal, $15,000 per month to cover additional costs and resources Montaur expected to incur or redirect due to the unavailability of Dr. Goldberg's services resulting from his service as interim Chief Executive Officer of Navidea. During the year ended December 31, 2014, the Company paid Montaur a total of $53,000. Dr. Goldberg's service as interim Chief Executive Officer terminated with the appointment of Ricardo J. Gonzalez as the Company's Chief Executive Officer effective October 13, 2014.
In March 2015, the Company initiated a second reduction in force that included seven staff members and three executives. The executives continued as employees during transition periods of varying lengths, depending upon the nature and extent of responsibilities transitioned or wound down.
During the year ended December 31, 2015, the Company recognized approximately $1.3 million of net expense as a result of the reduction in force, which included actual and estimated separation costs as well as the impact of accelerated vesting or forfeiture of certain equity awards resulting from the separation of $273,000.
The remaining accrued separation costs of $0 and $9,000 at December 31, 2016 and 2015, respectively, related to the Company's reductions in force represent the estimated cost of continuing healthcare coverage and separation payments, and are included in accrued liabilities and other on the consolidated balance sheets.
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Income Taxes | As of December 31, 2016 and 2015, our deferred tax assets were approximately $79.1 million and $74.2 million, respectively. The components of our deferred tax assets are summarized as follows:
Current accounting standards require a valuation allowance against deferred tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets may not be realized. Due to the uncertainty surrounding the realization of these deferred tax assets in future tax returns, all of the deferred tax assets have been fully offset by a valuation allowance at December 31, 2016 and 2015.
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities (including the impact of available carryback and carryforward periods), projected future taxable income, and tax-planning strategies in making this assessment. Based upon the level of historical taxable income and projections for future taxable income over the periods in which the deferred tax assets are deductible, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences or tax carryforwards as of December 31, 2016.
As of December 31, 2016 and 2015, we had U.S. net operating loss carryforwards of approximately $193.3 million and $177.6 million, respectively. Of those amounts, $15.3 million relates to stock-based compensation tax deductions in excess of book compensation expense (“APIC NOLs”) as of both December 31, 2016 and 2015, that will be credited to additional paid-in capital when such deductions reduce taxes payable as determined on a "with-and-without" basis. Accordingly, these APIC NOLs will reduce federal taxes payable if realized in future periods, but NOLs related to such benefits are not included in the table above.
As of December 31, 2016 and 2015, we also had state net operating loss carryforwards of approximately $28.2 million and $24.7 million, respectively. The state net operating loss carryforwards will begin expiring in 2032.
At December 31, 2016 and 2015, we had U.S. R&D credit carryforwards of approximately $9.4 million and $9.1 million, respectively.
There were no expirations of U.S. net operating loss carryforwards or R&D credit carryforwards during 2016 or 2015. The details of our U.S. net operating loss and federal R&D credit carryforward amounts and expiration dates are summarized as follows:
The credit for certain research and experimentation expenses expired at the end of 2014. The Protecting Americans From Tax Hikes Act of 2015 (the “Act”) was signed into law by President Obama on December 18, 2015. The Act extends the credit permanently.
During the years ended December 31, 2016, 2015 and 2014, Cardiosonix recorded losses for financial reporting purposes of $13,000, $11,000 and $15,000, respectively. As of December 31, 2016 and 2015, Cardiosonix had tax loss carryforwards in Israel of approximately $7.7 million and $7.6 million, respectively. Under current Israeli tax law, net operating loss carryforwards do not expire. Due to the uncertainty surrounding the realization of the related deferred tax assets in future tax returns and the Company’s intent to dissolve Cardiosonix in the near term, all of the deferred tax assets have been fully offset by a valuation allowance at December 31, 2016 and 2015.
Under Sections 382 and 383 of the IRC of 1986, as amended, the utilization of U.S. net operating loss and R&D tax credit carryforwards may be limited under the change in stock ownership rules of the IRC. The Company previously completed a Section 382 analysis in 2013 and does not believe a Section 382 ownership change has occurred since then that would impact utilization of the Company?s net operating loss and R&D tax credit carryforwards.
Reconciliations between the statutory federal income tax rate and our effective tax rate for continuing operations are as follows:
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Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 Tc 99m tilmanocept 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.
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Agreements |
12 Months Ended |
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Dec. 31, 2016 | |
Significant Agreements Disclosure [Abstract] | |
Agreements | a. Supply Agreements: In November 2009, we entered into a manufacture and supply agreement with Reliable Biopharmaceutical Corporation (Reliable) for the manufacture and supply of the Tc 99m tilmanocept drug substance. The initial ten-year term of the agreement expires in November 2019, with options to extend the agreement for successive three-year terms. Either party had the right to terminate the agreement upon mutual written agreement, or upon material breach by the other party if not cured within 60 days from the date of written notice of the breach. Total purchases under the manufacture and supply agreement were $1.1 million, $225,000 and $300,000 for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we had issued a purchase order under the manufacture and supply agreement with Reliable for $525,000 of Tc 99m tilmanocept drug substance for delivery during 2017. Upon closing of the Asset Sale to Cardinal Health 414, our contract and open purchase order with Reliable were transferred to Cardinal Health 414.
In May 2013, we entered into a clinical supply agreement with Nordion (Canada), Inc. (Nordion) for the manufacture and supply of NAV5001 clinical trial material. The initial three-year term expired in May 2016. In August 2014, in connection with the Company’s decision to refocus its resources, the Nordion agreement was amended to provide for a suspension period during which the Company was to pay a monthly fee to maintain production space at Nordion’s facility until such time as manufacture resumed. In March 2016, the Nordion agreement was terminated. Total purchases under the clinical supply agreement were $43,000, $244,000 and $505,000 for the years ended December 31, 2016, 2015 and 2014, respectively.
In August 2013, we entered into a manufacturing services agreement with PETNET Solutions, Inc. (PETNET) for the manufacture and distribution of NAV4694. The initial three-year term of the agreement expired in August 2016 and the agreement was not renewed. Total purchases under the manufacturing agreement were $826,000, $855,000 and $2.2 million for the years ended December 31, 2016, 2015 and 2014, respectively.
In September 2013, we entered into a manufacturing services agreement with OSO BioPharmaceuticals Manufacturing, LLC (OsoBio) for contract pharmaceutical development, manufacturing, packaging and analytical services for Tc 99m tilmanocept. Either party had the right to terminate the agreement upon mutual written agreement, or upon material breach by the other party if not cured within 60 days from the date of written notice of the breach. During the term of agreement, OsoBio was the primary supplier of manufacturing services for Tc 99m tilmanocept. In consideration for these services, the Company paid a unit pricing fee. In addition, the Company also paid OsoBio a fee for regulatory and other support services. Total purchases under the manufacturing services agreement were $1.2 million, $472,000 and $96,000 for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we had issued purchase orders under the agreement with OsoBio for $562,000 of our products for delivery during 2017. Upon closing of the Asset Sale to Cardinal Health 414, our contract and open purchase orders with OsoBio were transferred to Cardinal Health 414.
Also in September 2013, we completed a service and supply master agreement with Gipharma S.r.l. (Gipharma) for process development, manufacturing and packaging of reduced-mass vials to be sold in the EU. The agreement has an initial term of three years and automatically renews for an additional one-year periods unless written notice is provided at least six months prior to the expiration of the current term. Navidea may terminate the agreement for any reason by providing 60 days prior written notice. Either party may terminate the agreement upon material breach if not cured within 30 days from the date of written notice of the breach, or upon written notice following the other party’s dissolution or cessation of normal business. In consideration for these services, the Company will pay fees as defined in the agreement. Total purchases under the service and supply master agreement were $149,000, $677,000 and $272,000 for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we had issued purchase orders under the agreement with Gipharma for $1,500 of services for delivery during 2017. Following the transfer of the Tc 99m tilmanocept Marketing Authorization to SpePharm, our contract with Gipharma will be transferred to SpePharm.
b. Research and Development Agreements: In January 2002, we completed a license agreement with the University of California, San Diego (UCSD) for the exclusive world-wide rights to Tc 99m tilmanocept. The license agreement was effective until the later of the expiration date of the longest-lived underlying patent. In July 2014, we amended the license agreement to extend the agreement until the third anniversary of the expiration date of the longest-lived underlying patent. Under the terms of the license agreement, UCSD granted us the exclusive rights to make, use, sell, offer for sale and import licensed products as defined in the agreement and to practice the defined licensed methods during the term of the agreement. We could also sublicense the patent rights, subject to certain sublicense terms as defined in the agreement. In consideration for the license rights, we agreed to pay UCSD a license issue fee of $25,000 and license maintenance fees of $25,000 per year. We also agreed to make payments to UCSD upon successfully reaching certain clinical, regulatory and cumulative sales milestones, and a royalty on net sales of licensed products subject to a $25,000 minimum annual royalty. In addition, we agreed to reimburse UCSD for all patent-related costs and to meet certain diligence targets. Total costs related to the UCSD license agreement for Tc 99m tilmanocept were $955,000, $777,000 and $353,000 in 2016, 2015 and 2014, respectively. Royalties on net sales of Tc 99m tilmanocept were recorded in cost of goods sold, license maintenance fees and patent-related costs were recorded in research and development expenses, and sublicense fees were recorded in selling, general and administrative expenses.
In connection with the March 2017 closing of the Asset Sale to Cardinal Health 414, the Company amended and restated its Tc 99m tilmanocept license agreement with UCSD pursuant to which UCSD granted a license to the Company to exploit certain intellectual property rights owned by UCSD and, separately, Cardinal Health 414 entered into a license agreement with UCSD pursuant to which UCSD granted a license to Cardinal Health 414 to exploit certain intellectual property rights owned by UCSD for Cardinal Health 414 to sell the Product in the Territory. Pursuant to the Purchase Agreement, the Company granted to UCSD a five (5)-year warrant to purchase up to 1 million shares of the Company’s common stock, par value $.001 per share, at an exercise price of $1.50 per share. See Note 24(a).
In April 2008, we completed a second license agreement with UCSD for an expanded field of use allowing Tc 99m tilmanocept to be developed as an optical or ultrasound agent. The license agreement was effective until the expiration date of the longest-lived underlying patent. Under the terms of the license agreement, UCSD granted us the exclusive rights to make, use, sell, offer for sale and import licensed products as defined in the agreement and to practice the defined licensed methods during the term of the agreement. We could also sublicense the patent rights, subject to certain sublicense terms as defined in the agreement. In consideration for the license rights, we agreed to pay UCSD a license issue fee of $25,000 and license maintenance fees of $25,000 per year. We also agreed to make payments to UCSD upon successfully reaching certain clinical, regulatory and cumulative sales milestones, and a royalty on net sales of licensed products subject to a $25,000 minimum annual royalty. In addition, we agreed to reimburse UCSD for all patent-related costs and to meet certain diligence targets. Total costs related to the UCSD license agreement for the use of Tc 99m tilmanocept as an optical or ultrasound agent were $25,000 in 2014, and were recorded in research and development expenses. The license agreement for the use of Tc 99m tilmanocept as an optical or ultrasound agent was canceled in July 2014.
In July 2014, the Company replaced the license agreement for the use of Tc 99m tilmanocept as an optical or ultrasound agent with an expanded license agreement for the exclusive world-wide rights to all diagnostic and therapeutic uses of tilmanocept (other than Tc 99m tilmanocept). The license agreement is effective until the third anniversary of the expiration date of the longest-lived underlying patent. Under the terms of the license agreement, UCSD has granted us the exclusive rights to make, use, sell, offer for sale and import licensed products as defined in the agreement and to practice the defined licensed methods during the term of the agreement. We may also sublicense the patent rights, subject to certain sublicense terms as defined in the agreement. In consideration for the license rights, we agreed to pay UCSD a license issue fee of $25,000 and license maintenance fees of $25,000 per year. We also agreed to make payments to UCSD upon successfully reaching certain clinical, regulatory and cumulative sales milestones, and a royalty on net sales of licensed products subject to a $25,000 minimum annual royalty. In addition, we agreed to reimburse UCSD for all patent-related costs and to meet certain diligence targets. Total costs related to the UCSD license agreement for tilmanocept were $199,000, $152,000 and $25,000 in 2016, 2015 and 2014, respectively, and were recorded in research and development expenses.
In December 2011, we executed a license agreement with AstraZeneca AB for NAV4694, a proprietary compound that is primarily intended for use in diagnosing Alzheimer’s disease and other CNS disorders. The license agreement is effective until the later of the tenth anniversary of the first commercial sale of NAV4694 or the expiration of the underlying patents. Under the terms of the license agreement, AstraZeneca granted us an exclusive worldwide royalty-bearing license for NAV4694 with the right to grant sublicenses. In consideration for the license rights, we paid AstraZeneca a license issue fee of $5.0 million upon execution of the agreement. We also agreed to pay AstraZeneca up to $6.5 million in contingent milestone payments based on the achievement of certain clinical development and regulatory filing milestones, and up to $11.0 million in contingent milestone payments due following receipt of certain regulatory approvals and the initiation of commercial sales of the licensed product. In addition, we agreed to pay AstraZeneca a royalty on net sales of licensed and sublicensed products. Total costs related to the AstraZeneca license agreement were $116,000, $80,000 and $81,000 in 2016, 2015 and 2014, respectively, and were recorded in research and development expenses.
In July 2012, we entered into an agreement with Alseres Pharmaceuticals, Inc. (Alseres) to sublicense NAV5001, an Iodine-123 radiolabeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders, with a potential use as a diagnostic aid in dementia. Under the terms of the sublicense agreement, Alseres granted Navidea an exclusive, worldwide sublicense to research, develop and commercialize NAV5001. The terms of the agreement required Navidea to make a one-time sublicense execution payment to Alseres equal to (i) $175,000 in cash and (ii) 300,000 shares of our common stock. The sublicense agreement also provided for contingent milestone payments of up to $2.9 million, $2.5 million of which would have principally occurred at the time of product registration or upon commercial sales, and the issuance of up to an additional 1.15 million shares of Navidea common stock, 950,000 shares of which would have been issuable at the time of product registration or upon commercial sales. In addition, the sublicense terms anticipated royalties on annual net sales of the approved product which were consistent with industry-standard terms and certain sublicense extension fees, payable in cash and shares of common stock, in the event certain diligence milestones were not met. In April 2015, the Company entered into an agreement with Alseres to terminate the Alseres sublicense agreement. Under the terms of this agreement, Navidea transferred all regulatory, clinical and manufacturing-related data related to NAV5001 to Alseres. Alseres agreed to reimburse Navidea for any incurred maintenance costs of the contract manufacturer retroactive to March 1, 2015. In addition, Navidea has supplied clinical support services for NAV5001 on a cost-plus reimbursement basis. However, to this point, Alseres has been unsuccessful in raising the funds necessary to restart the program and reimburse Navidea. As a result, we have taken steps to end our obligations under the agreement and notified Alseres that we consider them in breach of the agreement. We are in the process of trying to recover the funds we expended complying with our obligations under the termination agreement. Total costs related to the Alseres sublicense agreement were $5,000 and $42,000 in 2015 and 2014, respectively, and were recorded in research and development expenses.
c. Employment Agreements: As of December 31, 2016, we had employment agreements with two of our senior officers. In addition, although certain employment agreements expired on or before December 31, 2016, the terms of the agreements provide for continuation of certain terms of the employment agreements as long as the senior officers continue to be employees of the Company following expiration of the agreements. The employment agreements contain termination and/or change in control provisions that would entitle each of the officers to 1.3 to 2.75 times their annual salaries, vest outstanding restricted stock and options to purchase common stock, and continue certain benefits if there is a termination without cause or change in control of the Company (as defined) and their employment terminates. As of December 31, 2016, our maximum contingent liability under these agreements in such an event is approximately $1.9 million. The employment agreements generally also provide for severance, disability and death benefits.
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Leases |
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Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases | We lease office space in Ohio under an operating lease that expires in October 2022. Beginning in March 2017, we also lease office space in New Jersey under an operating lease that expires in March 2018.
As of December 31, 2016, the future minimum lease payments for the years ending December 31 are as follows:
Total rental expense was $187,000, $217,000 and $357,000 for the years ended December 31, 2016, 2015 and 2014, respectively.
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Employee Benefit Plan |
12 Months Ended |
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Dec. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plan | We maintain an employee benefit plan under Section 401(k) of the Internal Revenue Code. The plan allows employees to make contributions and we may, but are not obligated to, match a portion of the employee’s contribution with our common stock, up to a defined maximum. We also pay certain expenses related to maintaining the plan. We recorded expenses related to our 401(k) plan of $101,000, $124,000 and $125,000 during 2016, 2015 and 2014, respectively.
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Supplemental Disclosure for Statements of Cash Flows |
12 Months Ended |
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Dec. 31, 2016 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental Disclosure for Statements of Cash Flows | During 2016, 2015 and 2014, we paid interest aggregating $5.5 million, $4.6 million and $2.9 million, respectively. Interest paid during 2016 included collection fees of $778,000 and a prepayment premium of $2.1 million, both of which were withdrawn by CRG from a bank account under their control. During 2016, 2015, and 2014, we issued 67,002, 68,157 and 36,455 shares of our common stock, respectively, as matching contributions to our 401(k) Plan which were valued at $121,000, $117,000 and $100,000, respectively. In December 2016, we prepaid $348,000 of insurance premiums through the issuance of a note payable to IPFS with an interest rate of 8.99%. During 2015 and 2014, we recorded $1.0 million and $2.4 million, respectively, of end-of-term fees associated with our notes payable to CRG and Oxford.
In connection with their initial investment in March 2015, the investors in MT were issued warrants that have been determined to be derivative liabilities with an estimated fair value of $63,000. A $46,000 deemed dividend related to the beneficial conversion feature within the MT Preferred Stock was also recorded at the time of the initial investment in MT. See Note 9.
During 2014, in connection with the Oxford Loan Agreement, we issued warrants with an estimated relative fair value of $465,000. Also during 2014, in connection with entering into the R-NAV joint enterprise, Navidea executed a promissory note in the principal amount of $666,666, payable in two equal installments on July 15, 2015 and July 15, 2016, the first and second anniversaries of the R-NAV transaction. See Note 10.
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Selected Quarterly Financial Data |
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Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) | Quarterly financial information for fiscal 2016 and 2015 are presented in the following table, in thousands, except per share data:
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Subsequent Events |
12 Months Ended | ||||||||||||
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Dec. 31, 2016 | |||||||||||||
Subsequent Events [Abstract] | |||||||||||||
Subsequent Events |
In exchange for the Acquired Assets, Cardinal Health 414 (i) made a cash payment to the Company at closing of approximately $80.6 million after adjustments based on inventory being transferred and an advance of $3 million of guaranteed earnout payments as part of the CRG settlement described below, (ii) assumed certain liabilities of the Company associated with the Product as specified in the Purchase Agreement, and (iii) agreed to make periodic earnout payments (to consist of contingent payments and milestone payments which, if paid, will be treated as additional purchase price) to the Company based on net sales derived from the purchased Product subject, in each case, to Cardinal Health 414’s right to off-set. In no event will the sum of all earnout payments, as further described in the Purchase Agreement, exceed $230 million over a period of ten years, of which $20.1 million are guaranteed payments for the three years immediately after closing of the Asset Sale. At the closing of the Asset Sale, $3 million of such earnout payments were advanced by Cardinal Health 414 to the Company, and paid to CRG as part of the Deposit Amount paid to CRG described below.
Upon closing of the Asset Sale, the Supply and Distribution Agreement between Cardinal Health 414 and the Company was terminated and, as a result, the provisions thereof are of no further force or effect (other than any indemnification, payment, notification or data sharing obligations which survive the termination). At the closing of the Asset Sale, Cardinal Health 414 paid to the Company $1.2 million, as an estimate of the accrued revenue sharing payments owed to the Company as of the closing date, net of prior payments.
In connection with the closing of the Asset Sale, the Company entered into a License-Back Agreement (the “License-Back”) with Cardinal Health 414. Pursuant to the License-Back, Cardinal Health 414 granted to the Company a sublicensable (subject to conditions) and royalty-free license to use certain intellectual property rights included in the Acquired Assets (as defined below) and owned by Cardinal Health 414 as of the closing of the Asset Sale to the extent necessary for the Company to (i) on an exclusive basis, subject to certain conditions, develop, manufacture, market, sell and distribute new pharmaceutical and other products that are not Competing Products (as defined in the License-Back), and (ii) on a non-exclusive basis, develop, manufacture, market, sell and distribute the Product (as defined below) throughout the world other than in the Territory. Subject to the Company’s compliance with certain restrictions in the License-Back, the License-Back also restricts Cardinal Health 414 from using the intellectual property rights included in the Acquired Assets to develop, manufacture, market, sell, or distribute any product other than the Product or other product that (a) accumulates in lymphatic tissue or tumor-draining lymph nodes for the purpose of (1) lymphatic mapping or (2) identifying the existence, location or staging of cancer in a body, or (b) provides for or facilitates any test or procedure that is reasonably substitutable for any test or procedure provided for or facilitated by the Product. Pursuant to the License-Back and subject to rights under existing agreements, Cardinal Health 414 was given a right of first offer to market, sell and/or market any new products developed from the intellectual property rights licensed by Cardinal Health 414 to the Company by the License-Back.
As part of the Asset Sale, the Company and Cardinal Health 414 also entered into ancillary agreements providing for transitional services and other arrangements. The Company amended and restated its Tc 99m tilmanocept license agreement with UCSD pursuant to which UCSD granted a license to the Company to exploit certain intellectual property rights owned by UCSD and, separately, Cardinal Health 414 entered into a license agreement with UCSD pursuant to which UCSD granted a license to Cardinal Health 414 to exploit certain intellectual property rights owned by UCSD for Cardinal Health 414 to sell the Product in the Territory.
Pursuant to the Purchase Agreement, the Company granted to each of Cardinal Health 414 and UCSD a five (5)-year warrant to purchase up to 10 million shares and 1 million shares, respectively, of the Company’s common stock, par value $.001 per share, at an exercise price of $1.50 per share, each of which warrant is subject to anti-dilution and other customary terms and conditions.
Prior to the Asset Sale, the Company had no material relationships with Cardinal Health 414 or its affiliates except that Cardinal Health 414 was the Company’s primary distributor of the Product throughout the United States pursuant to the Supply and Distribution Agreement which, as set forth above, was terminated as of the closing of the Asset Sale.
Post-closing and after paying off our outstanding indebtedness and transaction-related expenses, Navidea has approximately $15.6 million in cash and $3.7 million in payables, a large portion of which is tied to the 4694 program which Navidea is seeking to divest in the near term. Following the completion of the Asset Sale to Cardinal Health 414 and the repayment of a majority of our indebtedness, we believe that substantial doubt about the Company’s financial position and ability to continue as a going concern has been removed.
By letter dated February 21, 2017 (the “Letter”), CRG notified the Company that, in further exercise of its remedies under the CRG Loan Documents, including, without limitation, pursuant to Sections 4.01 through 4.13 and Section 5.04 of the Security Agreement and Sections 11.02 and 12.03 of the CRG Loan Agreement, CRG Servicing LLC, CRG’s representative, would sell (or lease or license, as applicable), at a public sale, (A) the stock of MT owned by the Company and pledged to CRG pursuant to the CRG Loan Documents and (B) the U.S. Collateral (as defined in the Security Agreement) related to Tc 99m tilmanocept on March 13, 2017. CRG claimed that, as of January 31, 2017, the outstanding obligations due under the CRG Loan Documents, including outstanding principal, interest, fees, and expenses, aggregated $63,198,774.46 (the “Asserted Payoff Amount”). CRG claimed that interest, fees and expenses would continue to accrue and CRG reserved the right to adjust or supplement the Asserted Payoff Amount prior to the date of the public sale. The Asserted Payoff Amount was also calculated by CRG to include costs incurred by CRG through January 31, 2017 in respect of indemnity obligations of the Company under Sections 12.03(a)(ii) and 12.03(b) of the CRG Loan Agreement (the “Indemnity Obligations”), which CRG claimed were secured obligations under the Security Agreement. CRG claimed that, unless and until all Indemnity Obligations (inclusive of costs incurred by CRG subsequent to January 31, 2017) are indefeasibly paid in full, in cash, as contemplated by the Security Agreement, such Indemnity Obligations would continue to be secured by the liens created by and perfected in accordance with the Security Agreement in all collateral not sold in the public sale, including any cash proceeds of the public sale in excess of the Asserted Payoff Amount, which cash proceeds would be deposited into an escrow account and would be subject to CRG’s continuing lien. CRG also noted that payment of the Asserted Payoff Amount (as such amount may be adjusted or supplemented immediately prior to the public sale) would not result in the indefeasible payment in full of the Secured Obligations unless payment of the Asserted Payoff Amount, as adjusted or supplemented, was concurrently accompanied by a general release by the Company, MT, as guarantor, and the successful bidder(s) of all present and future claims and counterclaims against CRG.
On March 3, 2017, the Company entered into a Global Settlement Agreement with MT, CRG, and Cardinal Health 414 to effectuate the terms of the settlement previously entered into by the parties on February 22, 2017. In accordance with the Global Settlement Agreement, on March 3, 2017, the Company repaid the $59 million Deposit Amount of its alleged indebtedness and other obligations outstanding under the CRG Term Loan. Concurrently with payment of the Deposit Amount, CRG released all liens and security interests granted under the CRG Loan Documents and the CRG Loan Documents were terminated and are of no further force or effect; provided, however, that, notwithstanding the foregoing, the Company and CRG agreed to continue with their proceeding pending in The District Court of Harris County, Texas to fully and finally determine the Final Payoff Amount. The Company and CRG further agreed that the Final Payoff Amount, inclusive of the $59 million repaid on March 3, 2017, would be no less than $47 million and no more than $66 million. In addition, concurrently with the payment of the Deposit Amount and closing of the Asset Sale, (i) Cardinal Health 414 agreed to post a $7 million letter of credit in favor of CRG (at the Company’s cost and expense to be deducted from the closing proceeds due to the Company, and subject to Cardinal Health 414’s indemnification rights under the Purchase Agreement) as security for the amount by which the High Payoff Amount exceeds the Deposit Amount in the event the Company is unable to pay all or a portion of such amount, and (ii) CRG agreed to post a $12 million letter of credit in favor of the Company as security for the amount by which the Deposit Amount exceeds the Low Payoff Amount. If, on the one hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents exceeds the Deposit Amount, the Company will pay such excess amount, plus the costs incurred by CRG in obtaining CRG’s letter of credit, to CRG and if, on the other hand, it is finally determined by the Texas Court that the amount the Company owes to CRG under the Loan Documents is less than the Deposit Amount, CRG will pay such difference to the Company and reimburse Cardinal Health 414 for the costs incurred by Cardinal Health 414 in obtaining its letter of credit. Any payments owing to CRG arising from a final determination that the Final Payoff Amount is in excess of $59 million shall first be paid by the Company without resort to the letter of credit posted by Cardinal Health 414, and such letter of credit shall only be a secondary resource in the event of failure of the Company to make payment to CRG. The Company will indemnify Cardinal Health 414 for any costs it incurs in payment to CRG under the settlement, and the Company and Cardinal Health 414 further agree that Cardinal Health 414 can pursue all possible remedies, including offset against earnout payments (guaranteed or otherwise) under the Purchase Agreement, warrant exercise, or any other payments owed by Cardinal Health 414, or any of its affiliates, to the Company, or any of its affiliates, if Cardinal Health 414 incurs any cost associated with payment to CRG under the settlement. The Company and CRG also agreed that the $2 million being held in escrow pursuant to court order in the Ohio case and the $3 million being held in escrow pursuant to court order in the Texas case would be released to the Company at closing of the Asset Sale. On March 3, 2017, Cardinal Health 414 posted a $7 million letter of credit, and on March 7, 2017, CRG posted a $12 million letter of credit, each as required by the Global Settlement Agreement. The trial date is currently set for July 3, 2017. See Note 12.
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Organization and Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization and Nature of Operations | Organization and Nature of Operations: Navidea Biopharmaceuticals, Inc. (“Navidea,” the “Company,” or “we”), a Delaware Corporation (NYSE MKT: NAVB), is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on our Manocept™ platform to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Lymphoseek® (technetium Tc 99m tilmanocept) injection, the first product developed and commercialized by Navidea based on the platform. Building on the success of Tc 99m tilmanocept, the flexible and versatile Manocept platform acts as an engine for the design of purpose-built molecules offering the potential to be utilized across a range of diagnostic modalities, including single photon emission computed tomography (“SPECT”), positron emission tomography (“PET”), intra-operative and/or optical-fluorescence detection in a variety of disease states. On March 3, 2017, pursuant to an Asset Purchase Agreement dated November 23, 2016, (the “Purchase Agreement”), the Company completed its previously announced sale to Cardinal Health 414, LLC (“Cardinal Health 414”) of its assets used, held for use, or intended to be used in operating its business of developing, manufacturing and commercializing a product used for lymphatic mapping, lymph node biopsy, and the diagnosis of metastatic spread to lymph nodes for staging of cancer (the “Business”), including the Company’s radioactive diagnostic agent marketed under the Lymphoseek® trademark for current approved indications by the U.S. Food and Drug Administration (“FDA”) and similar indications approved by the FDA in the future (the “Product”), in Canada, Mexico and the United States (the “Territory”) (giving effect to the License-Back described below and excluding certain assets specifically retained by the Company) (the “Asset Sale”). Such assets sold in the Asset Sale consist primarily of, without limitation, (i) intellectual property used in or reasonably necessary for the conduct of the Business, (ii) inventory of, and customer, distribution, and product manufacturing agreements related to, the Business, (iii) all product registrations related to the Product, including the new drug application approved by the FDA for the Product and all regulatory submissions in the United States that have been made with respect to the Product and all Health Canada regulatory submissions and, in each case, all files and records related thereto, (iv) all related clinical trials and clinical trial authorizations and all files and records related thereto, and (v) all right, title and interest in and to the Product, as specified in the Purchase Agreement (the “Acquired Assets”). Upon closing of the Asset Sale, the Supply and Distribution Agreement, dated November 15, 2007 (as amended, the “Supply and Distribution Agreement”), between Cardinal Health 414 and the Company was terminated and, as a result, the provisions thereof are of no further force or effect (other than any indemnification, payment, notification or data sharing obligations which survive the termination). The Asset Sale to Cardinal Health 414 in March 2017 significantly improved our financial condition and our ability to continue as a going concern. The Company also continues working to establish new sources of non-dilutive funding, including collaborations and grant funding that can augment the balance sheet as the Company works to reduce spending to levels that can be supported by our revenues. Other than Tc 99m tilmanocept, which the Company has a license to distribute outside of Canada, Mexico and the United States, none of the Company’s drug product candidates have been approved for sale in any market. In January 2015, Macrophage Therapeutics, Inc. (“MT”), a majority-owned subsidiary, was formed specifically to explore immuno-therapeutic applications for the Manocept platform. From our inception through August 2011, we also manufactured a line of gamma detection systems called the neoprobe® GDS system (the “GDS Business”). We sold the GDS Business to Devicor Medical Products, Inc. (“Devicor”) in August 2011. In exchange for the assets of the GDS Business, Devicor made net cash payments to us totaling $30.3 million, assumed certain liabilities of the Company associated with the GDS Business, and agreed to make royalty payments to us of up to an aggregate maximum amount of $20 million based on the net revenue attributable to the GDS Business through 2017. We recorded income of $759,000, net of taxes, in 2015 related to royalty amounts earned based on 2015 GDS Business revenue. The royalty amount of $1.2 million was offset by $436,000 in estimated taxes which were allocated to discontinued operations, but were fully offset by the tax benefit from our net operating loss for 2015. We did not earn or receive any such royalty payments prior to 2015 or in 2016. In December 2001, we acquired Cardiosonix Ltd. (“Cardiosonix”), an Israeli company with a blood flow measurement device product line in the early stages of commercialization. In August 2009, the Company’s Board of Directors decided to discontinue the operations and attempt to sell Cardiosonix. However, we were obligated to continue to service and support the Cardiosonix devices through 2013. The Company has not received significant expressions of interest in the Cardiosonix business and as such, we continue to wind down our activities in this area until a final shutdown of operations is completed.
In July 2011, we established a European business unit, Navidea Biopharmaceuticals Limited, to address international development and commercialization needs for our technologies, including Tc 99m tilmanocept. Navidea owns 100% of the outstanding shares of Navidea Biopharmaceuticals Limited. |
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Principles of Consolidation | Principles of Consolidation: Our consolidated financial statements include the accounts of Navidea and our wholly-owned subsidiaries, Navidea Biopharmaceuticals Limited and Cardiosonix Ltd, as well as those of our majority-owned subsidiary, Macrophage Therapeutics, Inc. (“MT”). All significant inter-company accounts were eliminated in consolidation. Prior to termination of Navidea’s joint venture with R-NAV, LLC (“R-NAV”), Navidea's investment in R-NAV was being accounted for using the equity method of accounting and was therefore not consolidated. See Note 10. |
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Use of Estimates | Use of Estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
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Financial Instruments and Fair Value | Financial Instruments and Fair Value: In accordance with current accounting standards, the fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value, giving the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:
Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and
Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In determining the appropriate levels, we perform a detailed analysis of the assets and liabilities whose fair value is measured on a recurring basis. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. See Note 3.
The following methods and assumptions were used to estimate the fair value of each class of financial instruments:
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Stock-Based Compensation | Stock-Based Compensation: At December 31, 2016, we have instruments outstanding under two stock-based compensation plans; the Fourth Amended and Restated 2002 Stock Incentive Plan (the “2002 Plan”) and the 2014 Stock Incentive Plan (the “2014 Plan”). Currently, under the 2014 Plan, we may grant incentive stock options, nonqualified stock options, and restricted stock awards to full-time employees and directors, and nonqualified stock options and restricted stock awards may be granted to our consultants and agents. Total shares authorized under each plan are 12 million shares and 5 million shares, respectively. Although instruments are still outstanding under the 2002 Plan, the plan has expired and no new grants may be made from it. Under both plans, the exercise price of each option is greater than or equal to the closing market price of our common stock on the date of the grant.
Stock options granted under the 2002 Plan and the 2014 Plan generally vest on an annual basis over one to four years. Outstanding stock options under the plans, if not exercised, generally expire ten years from their date of grant or up to 90 days following the date of an optionee’s separation from employment with the Company. We issue new shares of our common stock upon exercise of stock options.
In September 2016, the Board of Directors approved the 2016 Stock Incentive Plan (the “2016 Plan”), authorizing a total of 10 million shares. The 2016 Plan has not yet been approved by Navidea’s stockholders. In connection with Dr. Goldberg’s appointment as Chief Executive Officer of the Company in September 2016, the Board of Directors awarded options to purchase 5,000,000 shares of our common stock to Dr. Goldberg, subject to stockholder approval of the 2016 Plan. If approved, these stock options will vest 100% when the average closing price of the Company’s common stock over a period of five consecutive trading days equals or exceeds $2.50 per share, and expire on the tenth anniversary of the date of grant.
Stock-based payments to employees and directors, including grants of stock options, are recognized in the consolidated statement of operations based on their estimated fair values. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Expected volatilities are based on the Company’s historical volatility, which management believes represents the most accurate basis for estimating expected future volatility under the current circumstances. Navidea uses historical data to estimate forfeiture rates. The expected term of stock options granted is based on the vesting period and the contractual life of the options. The risk-free rate is based on the U.S. Treasury yield in effect at the time of the grant. The assumptions used to calculate the fair value of stock option awards granted during the years ended December 31, 2016, 2015 and 2014 are noted in the following table:
The portion of the fair value of stock-based awards that is ultimately expected to vest is recognized as compensation expense over either (1) the requisite service period or (2) the estimated performance period. Restricted stock awards are valued based on the closing stock price on the date of grant and amortized ratably over the estimated life of the award. Restricted stock may vest based on the passage of time, or upon occurrence of a specific event or achievement of goals as defined in the grant agreements. In such cases, we record compensation expense related to grants of restricted stock based on management’s estimates of the probable dates of the vesting events. Stock-based awards that do not vest because the requisite service period is not met prior to termination result in reversal of previously recognized compensation cost. See Note 4.
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Cash and Cash Equivalents | Cash and Cash Equivalents: Cash equivalents are highly liquid instruments such as U.S. Treasury bills, bank certificates of deposit, corporate commercial paper and money market funds which have maturities of less than 3 months from the date of purchase. |
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Accounts and Other Receivables | Accounts and Other Receivables: Accounts and other receivables are recorded net of an allowance for doubtful accounts. We estimate an allowance for doubtful accounts based on a review and assessment of specific accounts and other receivables and write off accounts when deemed uncollectible. See Note 6. |
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Inventory | Inventory: All components of inventory are valued at the lower of cost (first-in, first-out) or market. We adjust inventory to market value when the net realizable value is lower than the carrying cost of the inventory. Market value is determined based on estimated sales activity and margins. We estimate a reserve for obsolete inventory based on management’s judgment of probable future commercial use, which is based on an analysis of current inventory levels, estimated future sales and production rates, and estimated shelf lives. See Note 7. |
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Property and Equipment | Property and Equipment: Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is generally computed using the straight-line method over the estimated useful lives of the depreciable assets. Depreciation and amortization related to equipment under capital leases and leasehold improvements is recognized over the shorter of the estimated useful life of the leased asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized. See Note 8. |
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Intangible Assets | Intangible Assets: Intangible assets consist primarily of patents and trademarks. Intangible assets are stated at cost, less accumulated amortization. Patent costs are amortized using the straight-line method over the estimated useful lives of the patents of approximately 5 to 15 years. Patent application costs are deferred pending the outcome of patent applications. Costs associated with unsuccessful patent applications and abandoned intellectual property are expensed when determined to have no recoverable value. We evaluate the potential alternative uses of all intangible assets, as well as the recoverability of the carrying values of intangible assets, on a recurring basis. |
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Impairment or Disposal of Long-Lived Assets | Impairment or Disposal of Long-Lived Assets: Long-lived assets and certain identifiable intangibles are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. No impairment was recognized during the years ended December 31, 2016, 2015 or 2014. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. |
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Leases | Leases: Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet. See Note 20. |
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Derivative Instruments | Derivative Instruments: Derivative instruments embedded in contracts, to the extent not already a free-standing contract, are bifurcated from the debt instrument and accounted for separately. All derivatives are recorded on the consolidated balance sheet at fair value in accordance with current accounting guidelines for such complex financial instruments. Derivative liabilities with expiration dates within one year are classified as current, while those with expiration dates in more than one year are classified as long term. We do not use derivative instruments for hedging of market risks or for trading or speculative purposes. |
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Revenue Recognition | Revenue Recognition: Prior to the Asset Sale to Cardinal Health 414 in March 2017, we generated revenue primarily from sales of Lymphoseek. Our standard shipping terms are free on board (FOB) shipping point, and title and risk of loss passes to the customer upon delivery to a carrier for shipment. We generally recognize sales revenue related to sales of our products when the products are shipped. Our customers have no right to return products purchased in the ordinary course of business, however, we may allow returns in certain circumstances based on specific agreements.
We earned additional revenues based on a percentage of the actual net revenues achieved by Cardinal Health 414 on sales to end customers made during each fiscal year. The amount we charged Cardinal Health 414 related to end customer sales of Lymphoseek was subject to a retroactive annual adjustment. To the extent that we could reasonably estimate the end-customer prices received by Cardinal Health 414, we recorded sales based upon these estimates at the time of sale. If we were unable to reasonably estimate end customer sales prices related to products sold, we recorded revenue related to these product sales at the minimum (i.e., floor) price provided for under our distribution agreement with Cardinal Health 414. During the years ended December 31, 2016 and 2015, approximately 99% of Lymphoseek sales were made to Cardinal Health 414.
We also earn revenues related to our licensing and distribution agreements. The terms of these agreements may include payment to us of non-refundable upfront license fees, funding or reimbursement of research and development efforts, milestone payments if specified objectives are achieved, and/or royalties on product sales. We evaluate all deliverables within an arrangement to determine whether or not they provide value on a stand-alone basis. We recognize a contingent milestone payment as revenue in its entirety upon our achievement of a substantive milestone if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. We received a non-refundable upfront cash payment of $2.0 million from SpePharm AG upon execution of the SpePharm License Agreement in March 2015. We have determined that the license and other non-contingent deliverables do not have stand-alone value because the license could not be deemed to be fully delivered for its intended purpose unless we perform our other obligations, including specified development work. Accordingly, they do not meet the separation criteria, resulting in these deliverables being considered a single unit of account. As a result, revenue relating to the upfront cash payment was deferred and was being recognized on a straight-line basis over the estimated obligation period of two years. However, the remaining deferred revenue of $417,000 was recognized upon obtaining European approval of a reduced-mass vial in September 2016, several months earlier than originally anticipated.
We generate additional revenue from grants to support various product development initiatives. We generally recognize grant revenue when expenses reimbursable under the grants have been paid and payments under the grants become contractually due. Lastly, we recognized revenues from the provision of services to R-NAV and its subsidiaries through the termination of the R-NAV joint venture on May 31, 2016. See Note 10. |
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Research and Development Costs | Research and Development Costs: Research and development (?R&D?) expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits, and stock-based compensation, as well as travel, supplies, and other costs to support our R&D staff. External contracted services include clinical trial activities, manufacturing and control-related activities, and regulatory costs. R&D expenses are charged to operations as incurred. We review and accrue R&D expenses based on services performed and rely upon estimates of those costs applicable to the stage of completion of each project. |
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Income Taxes | Income Taxes: Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Due to the uncertainty surrounding the realization of the deferred tax assets in future tax returns, all of the deferred tax assets have been fully offset by a valuation allowance at December 31, 2016 and 2015.
Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no liability for uncertain tax positions was recorded as of December 31, 2016 or 2015 and we do not expect any significant changes in the next twelve months. Should we need to accrue interest or penalties on uncertain tax positions, we would recognize the interest as interest expense and the penalties as a selling, general and administrative expense. As of December 31, 2016, tax years 2013-2016 remained subject to examination by federal and state tax authorities. See Note 17. |
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Change in Accounting Principle and Recent Accounting Developments |
Change in Accounting Principle: In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-03, Simplifying the Presentation of Debt Issuance Costs. ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability rather than as an asset. The recognition and measurement guidance for debt issuance costs are not affected by ASU 2015-03. ASU 2015-03 was effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption was permitted. Entities must apply the amendments in ASU 2015-03 on a retrospective basis. In 2015, the Company adopted ASU 2015-03. We have reflected all remaining unamortized costs as a reduction of the debt on the balance sheets as of December 31, 2016 and 2015, and will continue to do so in future periods. The adoption of ASU 2015-03 had no impact on the consolidated statements of operations, stockholders' deficit or cash flows. In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes. ASU 2015-17 eliminates the requirement to bifurcate deferred taxes between current and noncurrent on the balance sheet and requires that deferred tax assets and liabilities be classified as noncurrent on the balance sheet. ASU 2015-17 may be applied retrospectively or prospectively and early adoption is permitted. We early-adopted ASU 2015-17 as of December 31, 2015 and the statement of financial position as of this date reflects the revised classification of current deferred tax assets and liabilities as noncurrent. Adoption of ASU 2015-17 resulted in a retrospective reclassification between current deferred tax assets and noncurrent deferred tax assets.
Recent Accounting Developments: In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 defines when and how companies are required to disclose going concern uncertainties, which must be evaluated each interim and annual period. ASU 2014-15 requires management to determine whether substantial doubt exists regarding the entity's going concern presumption. Substantial doubt about an entity's ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued (or available to be issued). If substantial doubt exists, certain disclosures are required; the extent of those disclosures depends on an evaluation of management's plans (if any) to mitigate the going concern uncertainty. ASU 2014-15 is effective prospectively for annual periods ending after December 15, 2016, and to annual and interim periods thereafter. Early adoption was permitted. The adoption of ASU 2014-15 did not have any effect on our consolidated financial statements, however it does affect disclosures.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). ASU 2016-02 requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. We expect the adoption of ASU 2016-02 to result in an increase in right-of-use assets and lease liabilities on our consolidated statement of financial position related to our leases that are currently classified as operating leases, primarily for office space. Management is currently evaluating the impact that the adoption of ASU 2016-02 will have on our consolidated financial statements.
In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers – Principal versus Agent Considerations (Reporting Revenue Gross versus Net). ASU 2016-08 does not change the core principle of the guidance, rather it clarifies the implementation guidance on principal versus agent considerations. ASU 2016-08 clarifies the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-08 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2014-09 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation. ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Some of the simplified areas apply only to nonpublic entities. ASU 2016-09 is effective for public business entities for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period. If an entity early adopts ASU 2016-09 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. Methods of adoption vary according to each of the amendment provisions. Management is currently evaluating the impact that the adoption of ASU 2016-09 will have on our consolidated financial statements.
In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers – Identifying Performance Obligations and Licensing. ASU 2016-10 does not change the core principle of the guidance, rather it clarifies the identification of performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. ASU 2016-10 clarifies the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-10 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016-120 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers – Narrow-Scope Improvements and Practical Expedients. ASU 2016-12 does not change the core principle of the guidance, rather it affects only certain narrow aspects of Topic 606, including assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. ASU 2016-12 affects the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-12 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016-12 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 addresses certain specific cash flow issues with the objective of reducing the existing diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement cash flows. ASU 2016-15 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted in any interim or annual period. If an entity early adopts ASU 2016-15 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. ASU 2016-15 should be applied using a retrospective transition method to each period presented, with certain exceptions. We adopted ASU 2016-15 upon issuance, which resulted in debt prepayment costs being classified as financing costs rather than operating costs on the statement of cash flows for the year ended December 31, 2016.
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows – Restricted Cash. ASU 2016-18 requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and restricted cash or equivalents. Therefore, restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption in permitted, including adoption in an interim period. If an entity early adopts ASU 2016-18 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes the interim period. Following the payoff of our CRG debt and release of our restricted cash in March 2017, we do not expect the adoption of ASU 2016-18 to have a material effect on our consolidated financial statements.
In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. ASU 2016-20 does not change the core principle of the guidance, rather it affects only certain narrow aspects of Topic 606, including loan guarantee fees, contract cost impairment testing, provisions for losses on construction- and production-type contracts, clarification of the scope of Topic 606, disclosure of remaining and prior-period performance obligations, contract modification, contract asset presentation, refund liability, advertising costs, fixed-odds wagering contracts in the casino industry, and cost capitalization for advisors to private and public funds. ASU 2016-20 affects the guidance in ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective. The effective date and transition requirements for ASU 2016-12 are the same as for ASU 2014-09, which was deferred by one year by ASU No. 2015-14, Revenue from Contracts with Customers – Deferral of the Effective Date. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016-20 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business. ASU 2017-01 provides a screen to determine when a set of assets and activities (collectively, a “set”) is not a business. The screen requires that when substantially all of the fair market value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. If the screen is not met, ASU 2017-01 (1) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output, and (2) removes the evaluation of whether a market participant could replace missing elements. ASU 2017-01 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those periods. ASU 2017-01 should be applied prospectively on or after the effective date. No disclosures are required at transition. Early adoption is permitted for certain transactions as described in ASU 2017-01. Management is currently evaluating the impact that the adoption of ASU 2017-01 will have on our consolidated financial statements. |
Organization and Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assumptions Used |
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Fair Value (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Liabilities Measured on Recurring Basis |
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Favir Value Assumptions Used |
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Stock-Based Compensation (Tables) |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock Options Activity |
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Schedule of Nonvested Restricted Stock Activity |
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Earnings Per Share (Tables) |
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Schedule of Weighted Average Number of Shares |
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Accounts and Other Receivables and Concentrations of Credit Risk (Tables) |
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Schedule of Accounts and Other Receivables Net of Allowance for Doubtful Accounts |
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Inventory (Tables) |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory |
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Property and Equipment (Tables) |
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Property, Plant and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property and Equipment |
* We amortize leasehold improvements over the term of the lease, which in all cases is shorter than the estimated useful life of the asset. |
Accounts Payable, Accrued Liabilities and Other (Tables) |
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Schedule ofAccounts Payable, Accrued Liabilities and Other |
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Equity Instruments (Tables) |
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Summary of Outstanding Warrant Activity |
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Income Taxes (Tables) |
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Schedule of Deferred Tax Assets |
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Schedule of NOL and Credit Carryforward Amounts |
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Schedule of Effective Income Tax Rate Reconciliation |
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Segments (Tables) |
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Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of segment reporting information |
|
Leases (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Lease Payments |
|
Selected Quarterly Financial Data (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Quarterly Financial Data |
|
Organization and Summary of Significant Accounting Policies (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, minimum | 59.00% | 61.00% | 61.00% |
Expected volatility, maximum | 75.00% | 64.00% | 67.00% |
Weighted-average volatility | 60.00% | 62.00% | 65.00% |
Expected dividends | 0.00% | 0.00% | 0.00% |
Risk-free rate, minimum | 1.20% | 1.50% | 1.60% |
Risk-free rate, maximum | 1.80% | 1.90% | 2.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years | 5 years 1 month 6 days | 5 years 3 months 18 days |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years | 6 years 3 months 18 days | 7 years 4 months 24 days |
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Organization And Summary Of Accounting Policies [Line Items] | |||
Fair value of notes payable | $ 61,600,000 | $ 64,000,000 | |
Derivative liabilities | 63,000 | 63,000 | |
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 |
Minimum [Member] | |||
Organization And Summary Of Accounting Policies [Line Items] | |||
Estimated useful lives, patent costs | 5 years | ||
Maximum [Member] | |||
Organization And Summary Of Accounting Policies [Line Items] | |||
Estimated useful lives, patent costs | 15 years |
Fair Value (Details 1) - $ / shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Fair Value Details 1 | ||
Estimated volatility | 76.00% | 58.00% |
Expected term (in years) | 4 years 9 months | 5 years 9 months |
Debt rate | 8.125% | 14.125% |
Beginning stock price | $ .64 | $ 1.33 |
Fair Value (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Fair Value Disclosures [Abstract] | |||
Platinum notes payable | $ 9,600,000 | $ 11,500,000 | |
Derivative liabilities | 63,000 | 63,000 | |
Increase in fair value of Level 3 liabilities | $ (2,900,000) | $ 615,000 | $ 1,300,000 |
Stock-Based Compensation (Details) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Number of Options | |||
Outstanding at beginning of year | 5,437,064 | ||
Granted | 479,457 | ||
Exercised | (50,000) | (146,625) | (468,000) |
Canceled and forfeited | (2,186,906) | ||
Expired | (299,000) | ||
Outstanding at end of year | 3,380,615 | 5,437,064 | |
Exercisable at end of year | 2,548,681 | ||
Weighted Average Exercise Price | |||
Outstanding at beginning of period | $ 1.96 | ||
Granted, | 1.05 | ||
Exercised | .27 | ||
Canceled and Forfeited | 1.69 | ||
Expired | 2.42 | ||
Outstanding at end of period | 2.00 | $ 1.96 | |
Exercisable at end of period | $ 2.07 | ||
Weighted Average Remaining Contractual Life (years) | |||
Outstanding at end of year | 6 years 6 months | ||
Exercisable at end of year | 6 years 1 month 6 days | ||
Aggregate Intrinsic Value | |||
Outstanding at end of year | $ 1,601,300 | ||
Exercisable at end of year | $ 1,601,300 |
Stock-Based Compensation (Details 1) - $ / shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Number of Shares | |||
Unvested at beginning of period, shares | 361,000 | ||
Granted, shares | 168,000 | ||
Forfeited, shares | (206,000) | ||
Expired, shares | (50,000) | ||
Vested, shares | (66,000) | (33,250) | (216,250) |
Unvested at end of period, shares | 207,000 | 361,000 | |
Weighted Average Grant-Date Fair Value | |||
Unvested at beginning of period | $ 1.69 | ||
Granted | 1.20 | ||
Forfeited | 1.77 | ||
Expired | 1.93 | ||
Vested | 1.65 | ||
Unvested at end of period | $ 1.17 | $ 1.69 |
Earnings Per Share (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2016 |
Sep. 30, 2016 |
Jun. 30, 2016 |
Mar. 31, 2016 |
Dec. 31, 2015 |
Sep. 30, 2015 |
Jun. 30, 2015 |
Mar. 31, 2015 |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||
Net loss | $ (14,309,031) | $ (27,563,535) | $ (35,726,669) | ||||||||||||||||||
Less loss attributable to noncontrolling interest | (648) | (855) | 0 | ||||||||||||||||||
Deemed dividend on beneficial conversion feature of MT Preferred Stock | 0 | (46,000) | 0 | ||||||||||||||||||
Net loss attributable to common stockholders | $ (3,883,000) | $ (59,000) | $ (6,681,000) | $ (3,686,000) | $ (8,071,000) | $ (2,510,000) | $ (9,691,000) | $ (7,337,000) | $ (14,308,383) | $ (27,608,680) | $ (35,726,669) | ||||||||||
Weighted average shares outstanding (basic and diluted), in shares | 155,422,384 | 151,180,222 | 148,748,396 | ||||||||||||||||||
Loss per common share (basic and diluted), in dollars per share | $ (0.03) | [1] | $ (0.00) | [1] | $ (0.04) | [1] | $ (0.02) | [1] | $ (0.05) | [1] | $ (0.02) | [1] | $ (0.06) | [1] | $ (0.05) | [1] | $ (0.09) | $ (0.18) | $ (0.24) | ||
|
Earnings Per Share (Details Narrative) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Stock Options Warrants Convertible Debt And Convertible Preferred Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Shares excluded in determining basic and diluted loss per share | 14,100,000 | 14,600,000 | 19,000,000 |
Restricted Stock Units R S U [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Shares excluded in determining basic and diluted loss per share | 207,000 | 361,000 | 498,250 |
Accounts and Other Receivables and Concentrations of Credit Risk (Details) - USD ($) |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and other receivables net of allowance for doubtful accounts | $ 1,802,010 | $ 3,703,186 |
Trade Accounts Receivable [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and other receivables net of allowance for doubtful accounts | 1,617,414 | 2,498,087 |
Other Accounts Receivable [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and other receivables net of allowance for doubtful accounts | $ 184,596 | $ 1,205,099 |
Accounts and Other Receivables and Concentrations of Credit Risk (Details Narrative) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Accounts Receivable And Concentrations Of Credit Risk [Line Items] | ||
Allowance for doubtful accounts receivable | $ 0 | $ 0 |
Accounts And Other Receivable [Member] | Cardinal Health Inc [Member] | ||
Accounts Receivable And Concentrations Of Credit Risk [Line Items] | ||
Percentage of net accounts and other receivables | 89.00% | 67.00% |
Accounts And Other Receivable [Member] | Devicor Medical Products Inc [Member] | ||
Accounts Receivable And Concentrations Of Credit Risk [Line Items] | ||
Percentage of net accounts and other receivables | 32.00% |
Inventory (Details) - USD ($) |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw Materials | $ 658,650 | $ 330,000 |
Work in Process | 616,522 | 392,457 |
Finished Goods | 195,654 | 275,168 |
Reserves | 0 | (344,719) |
Total | $ 1,470,826 | $ 652,906 |
Inventory (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Inventory [Line Items] | |||
Inventory reserves | $ 0 | $ 344,719 | |
Inventory write-down | 43,354 | 143,493 | $ 539,027 |
Production [Member] | |||
Inventory [Line Items] | |||
Inventory write-down | $ 0 | $ 120,000 |
Property and Equipment (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Property, Plant and Equipment [Line Items] | |||
Property and equipment | $ 3,584,628 | $ 3,871,035 | |
Accumulated amortization | 2,333,070 | 1,943,427 | |
Depreciation and amortization of property and equipment | $ 496,178 | 562,468 | $ 487,906 |
Assets Held Under Capital Leases [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment | 9,000 | ||
Accumulated amortization | $ 7,000 |
Investment in R-NAV, LLC (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Equity Method Investments and Joint Ventures [Abstract] | |||
Equity in loss of R-NAV, LLC | $ 15,159 | $ 305,253 | $ 523,809 |
Cost of services provided | $ 15,000 | $ 64,000 | $ 39,000 |
Accounts Payable, Accrued Liabilities and Otherr (Details) - USD ($) |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Accrued Liabilities and Other Liabilities [Abstract] | ||
Interest | $ 5,756,519 | $ 478 |
Contracted services | 1,341,601 | 1,887,281 |
Compensation | 945,787 | 873,726 |
Royalties | 139,957 | 175,679 |
Other | 281,651 | 101,549 |
Accrued liabilities and other, Total | $ 8,465,515 | $ 3,038,713 |
Notes Payable (Details Narrative) - USD ($) |
12 Months Ended | |||
---|---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
|
Debt Disclosure [Abstract] | ||||
Platinum notes payable | $ 9,600,000 | $ 11,500,000 | ||
Increase in fair value of Level 3 liabilities | (2,900,000) | 615,000 | $ 1,300,000 | |
Line of credit draw down | 0 | 4,500,000 | 0 | $ 4,000,000 |
Interest expense | 14,900,000 | 6,900,000 | 3,700,000 | |
Interest expense recorded related to amortization | 2,000,000 | 493,000 | $ 8,440,000 | |
Term loan | $ 51,700,000 | $ 51,300,000 |
Equity Instruments (Details) |
12 Months Ended | |||
---|---|---|---|---|
Dec. 31, 2016
$ / shares
shares
| ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ .33 | [1] | ||
Number of Warrants | shares | 11,344,367 | |||
Series BB Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ 2.00 | |||
Number of Warrants | shares | 300,000 | |||
Expiration Date | Jul. 16, 2018 | |||
Series HH Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ 2.49 | |||
Number of Warrants | shares | 301,205 | |||
Expiration Date | Jun. 25, 2023 | |||
Series II Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ 3.04 | |||
Number of Warrants | shares | 275,000 | |||
Expiration Date | Jun. 25, 2018 | |||
Series KK Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ 1.918 | |||
Number of Warrants | shares | 391,032 | |||
Expiration Date | Mar. 04, 2021 | |||
Series LL Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ .01 | |||
Number of Warrants | shares | 9,777,130 | |||
Expiration Date | Aug. 20, 2035 | |||
Series MM Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ 2.50 | |||
Number of Warrants | shares | 150,000 | |||
Expiration Date | Sep. 08, 2019 | |||
Series MM Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise Price | $ / shares | $ 2.50 | |||
Number of Warrants | shares | 150,000 | |||
Expiration Date | Oct. 19, 2019 | |||
|
Equity Instruments (Details Narrative) |
Dec. 31, 2016
shares
|
---|---|
Equity Instruments Details Narrative | |
Warrants outstanding | 11,344,367 |
Common stock reserved for future issuance | 18,641,776 |
Reductions in Force (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2016 |
|
Restructuring Reserve [Abstract] | |||
Restructuring costs | $ 1,300,000 | $ 557,000 | |
Accrued separation costs | $ 9,000 | $ 0 |
Income Taxes (Details) - USD ($) |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Deferred tax assets: | ||
Net operating loss carryforwards | $ 66,150,646 | $ 60,129,827 |
R&D credit carryforwards | 9,729,673 | 9,465,900 |
Stock compensation | 1,368,458 | 1,898,394 |
Intangibles | 1,720,761 | 1,921,934 |
Temporary differences | 132,475 | 801,002 |
Deferred tax assets before valuation allowance | 79,102,014 | 74,217,057 |
Valuation allowance | (79,102,014) | (74,217,057) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details 1) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Operating Loss Carryforwards [Line Items] | ||
U.S. Net Operating Loss Carryforwards | $ 193,270,891 | $ 177,600,000 |
U.S. R&D Credit Carryforwards | $ 9,729,673 | $ 9,465,900 |
Nineteen Ninety Eight [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2018 | |
U.S. Net Operating Loss Carryforwards | $ 17,142,781 | |
U.S. R&D Credit Carryforwards | $ 1,173,387 | |
Nineteen Ninety Nine [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2019 | |
U.S. Net Operating Loss Carryforwards | $ 0 | |
U.S. R&D Credit Carryforwards | $ 130,359 | |
Two Thousand [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2020 | |
U.S. Net Operating Loss Carryforwards | $ 0 | |
U.S. R&D Credit Carryforwards | $ 71,713 | |
Two Thousand One [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2021 | |
U.S. Net Operating Loss Carryforwards | $ 0 | |
U.S. R&D Credit Carryforwards | $ 39,128 | |
Two Thousand Two [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2022 | |
U.S. Net Operating Loss Carryforwards | $ 1,282,447 | |
U.S. R&D Credit Carryforwards | $ 5,350 | |
Two Thousand Three [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2023 | |
U.S. Net Operating Loss Carryforwards | $ 337,714 | |
U.S. R&D Credit Carryforwards | $ 2,905 | |
Two Thousand Four [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2024 | |
U.S. Net Operating Loss Carryforwards | $ 1,237,146 | |
U.S. R&D Credit Carryforwards | $ 22,861 | |
Two Thousand Five [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2025 | |
U.S. Net Operating Loss Carryforwards | $ 2,999,083 | |
U.S. R&D Credit Carryforwards | $ 218,332 | |
Two Thousand Six [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2026 | |
U.S. Net Operating Loss Carryforwards | $ 3,049,735 | |
U.S. R&D Credit Carryforwards | $ 365,541 | |
Two Thousand Seven [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2027 | |
U.S. Net Operating Loss Carryforwards | $ 2,842,078 | |
U.S. R&D Credit Carryforwards | $ 342,898 | |
Two Thousand Eight [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2028 | |
U.S. Net Operating Loss Carryforwards | $ 2,777,503 | |
U.S. R&D Credit Carryforwards | $ 531,539 | |
Two Thousand Nine [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2029 | |
U.S. Net Operating Loss Carryforwards | $ 13,727,950 | |
U.S. R&D Credit Carryforwards | $ 596,843 | |
Twenty Ten [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2030 | |
U.S. Net Operating Loss Carryforwards | $ 5,397,680 | |
U.S. R&D Credit Carryforwards | $ 1,094,449 | |
Twenty Eleven [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2031 | |
U.S. Net Operating Loss Carryforwards | $ 1,875,665 | |
U.S. R&D Credit Carryforwards | $ 1,950,744 | |
Twenty Twelve [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2032 | |
U.S. Net Operating Loss Carryforwards | $ 28,406,659 | |
U.S. R&D Credit Carryforwards | $ 468,008 | |
Twenty Thirteen [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2033 | |
U.S. Net Operating Loss Carryforwards | $ 37,450,522 | |
U.S. R&D Credit Carryforwards | $ 681,772 | |
Twenty Fourteen [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2034 | |
U.S. Net Operating Loss Carryforwards | $ 34,088,874 | |
U.S. R&D Credit Carryforwards | $ 816,116 | |
Twenty Fifteen [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2035 | |
U.S. Net Operating Loss Carryforwards | $ 25,073,846 | |
U.S. R&D Credit Carryforwards | $ 492,732 | |
Twenty Sixteen [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration dates | Dec. 31, 2036 | |
U.S. Net Operating Loss Carryforwards | $ 15,581,209 | |
U.S. R&D Credit Carryforwards | $ 358,404 |
Income Taxes (Details 2) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Amount | |||
Benefit at statutory rate | $ (4,864,851) | $ (9,777,786) | $ (12,147,068) |
Adjustments to valuation allowance | 4,838,082 | 9,728,667 | 12,925,380 |
Adjustments to R&D credit carryforwards | (239,049) | (612,087) | (340,886) |
Disqualified debt interest | 188,060 | 438,007 | 0 |
Permanent items and other | 77,758 | (212,852) | (437,426) |
Benefit per financial statements | $ 0 | $ (436,051) | $ 0 |
Percent | |||
Benefit at statutory rate | (34.00%) | (34.00%) | (34.00%) |
Adjustments to valuation allowance | 33.80% | 33.80% | 36.20% |
Adjustments to R&D credit carryforwards | (1.60%) | (2.10%) | (1.00%) |
Disqualified debt interest | 1.30% | 1.50% | 0.00% |
Permanent items and other | 0.50% | (0.70%) | (1.20%) |
Income Taxes (Details Narrative) - USD ($) |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Operating Loss Carryforwards [Line Items] | ||
Deferred tax assets before valuation allowance | $ 79,102,014 | $ 74,217,057 |
Net operating loss carryforwards | 193,270,891 | 177,600,000 |
Operating loss carryforwards due to stock-based compensation tax deductions in excess of book compensation expense | 15,300,000 | 15,300,000 |
R&D credit carryforwards | 9,729,673 | 9,465,900 |
State And Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 28,200,000 | $ 24,700,000 |
Segments (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2016 |
Sep. 30, 2016 |
Jun. 30, 2016 |
Mar. 31, 2016 |
Dec. 31, 2015 |
Sep. 30, 2015 |
Jun. 30, 2015 |
Mar. 31, 2015 |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | $ 2,332,000 | $ 6,690,000 | $ 4,232,000 | $ 3,783,000 | $ 2,953,000 | $ 3,503,000 | $ 1,964,000 | $ 1,835,000 | $ 17,037,098 | $ 10,254,352 | $ 4,233,953 |
Lymphoseek license revenue | 0 | 1,296,000 | 246,000 | 254,000 | 550,000 | 250,000 | 250,000 | 83,000 | 1,795,625 | 1,133,333 | 300,000 |
Grant and other revenue | 1,023,000 | 511,000 | 917,000 | 686,000 | 477,000 | 541,000 | 654,000 | 190,000 | 3,136,983 | 1,861,622 | 1,740,896 |
Total revenue | 21,969,706 | 13,249,307 | 6,274,849 | ||||||||
Cost of goods sold, excluding depreciation and amortization | 2,192,902 | 1,654,800 | |||||||||
Research and development expenses, excluding depreciation and amortization | 8,882,576 | 12,777,116 | |||||||||
Selling, general and administrative expenses, excluding depreciation and amortization | 12,616,334 | 16,796,490 | |||||||||
Depreciation and amortization | 501,369 | 571,419 | |||||||||
Income (loss) from operations | (2,433,000) | $ 3,358,000 | $ (580,000) | $ (2,568,000) | (4,323,000) | $ (2,601,000) | $ (3,811,000) | $ (7,816,000) | (2,223,475) | (18,550,518) | (27,632,956) |
Other income (expense), excluding equity in the loss of R-NAV, LLC | (12,070,397) | (9,902,424) | |||||||||
Equity in the loss of R-NAV, LLC | (15,159) | (305,253) | (523,809) | ||||||||
Benefit from income taxes | 0 | 436,051 | 0 | ||||||||
Net loss from continuing operations | (28,322,144) | ||||||||||
Income from discontinued operations, net of tax effect | 0 | 758,609 | 0 | ||||||||
Net income (loss) | (14,309,031) | (27,563,535) | (35,726,669) | ||||||||
Total assets, net of depreciation and amortization | 12,461,676 | 14,964,513 | 12,461,676 | 14,964,513 | |||||||
Payments to Acquire Property, Plant, and Equipment | 1,847 | 39,001 | $ 1,114,448 | ||||||||
U S | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 16,982,234 | 10,229,659 | |||||||||
Total assets, net of depreciation and amortization | 12,329,143 | 14,552,834 | 12,329,143 | 14,552,834 | |||||||
Non Us [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 54,864 | 24,693 | |||||||||
Total assets, net of depreciation and amortization | 132,533 | 411,679 | 132,533 | 411,679 | |||||||
Diagnostics Segment [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek license revenue | 1,795,625 | 1,133,333 | |||||||||
Grant and other revenue | 3,012,217 | 1,861,622 | |||||||||
Total revenue | 21,844,940 | 13,249,307 | |||||||||
Cost of goods sold, excluding depreciation and amortization | 2,192,902 | 1,654,800 | |||||||||
Research and development expenses, excluding depreciation and amortization | 8,120,425 | 12,046,221 | |||||||||
Selling, general and administrative expenses, excluding depreciation and amortization | 3,652,154 | 5,852,214 | |||||||||
Depreciation and amortization | 104,138 | 281,314 | |||||||||
Income (loss) from operations | 7,775,321 | (6,585,242) | |||||||||
Other income (expense), excluding equity in the loss of R-NAV, LLC | 0 | 0 | |||||||||
Equity in the loss of R-NAV, LLC | 0 | 0 | |||||||||
Benefit from income taxes | 0 | ||||||||||
Net loss from continuing operations | (6,585,242) | ||||||||||
Income from discontinued operations, net of tax effect | 0 | ||||||||||
Net income (loss) | 7,775,321 | (6,585,242) | |||||||||
Payments to Acquire Property, Plant, and Equipment | 0 | 26,589 | |||||||||
Diagnostics Segment [Member] | U S | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 16,982,234 | 10,229,659 | |||||||||
Total assets, net of depreciation and amortization | 3,610,354 | 3,948,971 | 3,610,354 | 3,948,971 | |||||||
Diagnostics Segment [Member] | Non Us [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 54,864 | 24,693 | |||||||||
Total assets, net of depreciation and amortization | 131,752 | 410,666 | 131,752 | 410,666 | |||||||
Therapeutics Segment [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek license revenue | 0 | 0 | |||||||||
Grant and other revenue | 124,766 | 0 | |||||||||
Total revenue | 124,766 | 0 | |||||||||
Cost of goods sold, excluding depreciation and amortization | 0 | 0 | |||||||||
Research and development expenses, excluding depreciation and amortization | 762,151 | 730,895 | |||||||||
Selling, general and administrative expenses, excluding depreciation and amortization | 63,158 | 123,884 | |||||||||
Depreciation and amortization | 0 | 0 | |||||||||
Income (loss) from operations | (700,543) | (854,779) | |||||||||
Other income (expense), excluding equity in the loss of R-NAV, LLC | 0 | 0 | |||||||||
Equity in the loss of R-NAV, LLC | 0 | 0 | |||||||||
Benefit from income taxes | 0 | ||||||||||
Net loss from continuing operations | (854,779) | ||||||||||
Income from discontinued operations, net of tax effect | 0 | ||||||||||
Net income (loss) | (700,543) | (854,779) | |||||||||
Payments to Acquire Property, Plant, and Equipment | 0 | 0 | |||||||||
Therapeutics Segment [Member] | U S | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 0 | 0 | |||||||||
Total assets, net of depreciation and amortization | 15,075 | 0 | 15,075 | 0 | |||||||
Therapeutics Segment [Member] | Non Us [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 0 | 0 | |||||||||
Total assets, net of depreciation and amortization | 0 | 0 | 0 | 0 | |||||||
Corporate Non Segment [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek license revenue | 0 | 0 | |||||||||
Grant and other revenue | 0 | 0 | |||||||||
Total revenue | 0 | 0 | |||||||||
Cost of goods sold, excluding depreciation and amortization | 0 | 0 | |||||||||
Research and development expenses, excluding depreciation and amortization | 0 | 0 | |||||||||
Selling, general and administrative expenses, excluding depreciation and amortization | 8,901,022 | 10,820,392 | |||||||||
Depreciation and amortization | 397,231 | 290,105 | |||||||||
Income (loss) from operations | (9,298,253) | (11,110,497) | |||||||||
Other income (expense), excluding equity in the loss of R-NAV, LLC | (12,070,397) | (9,902,424) | |||||||||
Equity in the loss of R-NAV, LLC | (15,159) | (305,253) | |||||||||
Benefit from income taxes | 436,051 | ||||||||||
Net loss from continuing operations | (20,882,123) | ||||||||||
Income from discontinued operations, net of tax effect | 758,609 | ||||||||||
Net income (loss) | (21,383,809) | (20,123,514) | |||||||||
Payments to Acquire Property, Plant, and Equipment | 1,847 | 12,412 | |||||||||
Corporate Non Segment [Member] | U S | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 0 | 0 | |||||||||
Total assets, net of depreciation and amortization | 8,703,714 | 10,603,863 | 8,703,714 | 10,603,863 | |||||||
Corporate Non Segment [Member] | Non Us [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Lymphoseek sales revenue | 0 | 0 | |||||||||
Total assets, net of depreciation and amortization | $ 781 | $ 1,013 | $ 781 | $ 1,013 |
Agreements (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Agreements [Line Items] | |||
Purchases under manufacture and supply agreement | $ 1,100,000 | $ 225,000 | $ 300,000 |
Purchases under clinical supply agreement | 43,000 | 244,000 | 505,000 |
Purchases under manufacturing agreement | 826,000 | 855,000 | 2,200,000 |
Purchases under manufacturing services agreement | 1,200,000 | 472,000 | 96,000 |
Purchases under service and supply master agreement | 149,000 | 677,000 | 272,000 |
Total costs related to the license agreement | 8,882,576 | 12,777,116 | |
Maximum contingent liability | 1,900,000 | ||
Tc 99m Tilmanocept | |||
Agreements [Line Items] | |||
Total costs related to the license agreement | 955,000 | 777,000 | 353,000 |
Tilmanocept | |||
Agreements [Line Items] | |||
Total costs related to the license agreement | 199,000 | 152,000 | 25,000 |
AstraZeneca | |||
Agreements [Line Items] | |||
Total costs related to the license agreement | $ 116,000 | 80,000 | 81,000 |
Alseres | |||
Agreements [Line Items] | |||
Total costs related to the license agreement | $ 5,000 | $ 42,000 |
Leases (Details) |
Dec. 31, 2016
USD ($)
|
---|---|
Operating Leases | |
2017 | $ 277,946 |
2018 | 284,246 |
2019 | 290,734 |
2020 | 297,405 |
2021 | 304,201 |
Thereafter | 253,339 |
Total future payments of operating leases | $ 1,707,871 |
Leases (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Leases [Abstract] | |||
Rent expense | $ 187,000 | $ 217,000 | $ 357,000 |
Employee Benefit Plan (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Compensation and Retirement Disclosure [Abstract] | |||
Expenses related to employee benefits plan | $ 101,000 | $ 124,000 | $ 125,000 |
Supplemental Disclosure for Statements of Cash Flows (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Supplemental Cash Flow Elements [Abstract] | |||
Cash paid during the period for interest | $ 5,500,000 | $ 4,600,000 | $ 2,900,000 |
Collection fees | 778,000 | ||
Prepayment premium | $ 2,100,000 | ||
Issued stock to 401(k) plan, shares | 67,002 | 68,157 | 36,455 |
Issued stock to 401(k) plan for employer matching contributions | $ 120,800 | $ 117,099 | $ 100,043 |
Prepaid insurance premiums | $ 348,000 | ||
Notes payable end of term fees | $ 1,000,000 | $ 2,400,000 |
Selected Quarterly Financial Data (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2016 |
Sep. 30, 2016 |
Jun. 30, 2016 |
Mar. 31, 2016 |
Dec. 31, 2015 |
Sep. 30, 2015 |
Jun. 30, 2015 |
Mar. 31, 2015 |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|||||||||||
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||
Lymphoseek sales revenue | $ 2,332,000 | $ 6,690,000 | $ 4,232,000 | $ 3,783,000 | $ 2,953,000 | $ 3,503,000 | $ 1,964,000 | $ 1,835,000 | $ 17,037,098 | $ 10,254,352 | $ 4,233,953 | ||||||||||
Lymphoseek license revenue | 0 | 1,296,000 | 246,000 | 254,000 | 550,000 | 250,000 | 250,000 | 83,000 | 1,795,625 | 1,133,333 | 300,000 | ||||||||||
Grant and other revenue | 1,023,000 | 511,000 | 917,000 | 686,000 | 477,000 | 541,000 | 654,000 | 190,000 | 3,136,983 | 1,861,622 | 1,740,896 | ||||||||||
Gross profit | 3,076,000 | 7,575,000 | 4,834,000 | 4,188,000 | 3,522,000 | 3,778,000 | 2,535,000 | 1,659,000 | 19,672,666 | 11,494,544 | 4,688,704 | ||||||||||
Operating expenses | 5,509,000 | 4,217,000 | 5,414,000 | 6,756,000 | 7,845,000 | 6,379,000 | 6,346,000 | 9,475,000 | 21,896,141 | 30,045,062 | 32,321,660 | ||||||||||
Operating income (loss) | (2,433,000) | 3,358,000 | (580,000) | (2,568,000) | (4,323,000) | (2,601,000) | (3,811,000) | (7,816,000) | (2,223,475) | (18,550,518) | (27,632,956) | ||||||||||
Net loss attributable to common stockholders | $ (3,883,000) | $ (59,000) | $ (6,681,000) | $ (3,686,000) | $ (8,071,000) | $ (2,510,000) | $ (9,691,000) | $ (7,337,000) | $ (14,308,383) | $ (27,608,680) | $ (35,726,669) | ||||||||||
Basic and diluted net loss per share | $ (0.03) | [1] | $ (0.00) | [1] | $ (0.04) | [1] | $ (0.02) | [1] | $ (0.05) | [1] | $ (0.02) | [1] | $ (0.06) | [1] | $ (0.05) | [1] | $ (0.09) | $ (0.18) | $ (0.24) | ||
|
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