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x
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Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934
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o
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Delaware
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77-0160744
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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3911 Sorrento Valley Boulevard, Suite 110 San Diego, CA
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92121
(Zip Code)
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(Address of principal executive offices)
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Large Accelerated Filer
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x
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Accelerated Filer
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o
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Non-Accelerated Filer
|
o
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(Do not check if a smaller reporting company)
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Smaller Reporting Company
|
o
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Emerging Growth Company
|
o
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PART I. FINANCIAL INFORMATION
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ITEM 1. Financial Statements
(Unaudited)
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PART II. OTHER INFORMATION
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GLOSSARY OF TERMS AND ABBREVIATIONS
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Abbreviation
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Definition
|
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2019 Convertible Senior Notes
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$245.0 million aggregate principal amount of convertible senior unsecured notes due 2019
|
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Amgen
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Amgen, Inc.
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ASC
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Accounting Standards Codification
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ASU
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Accounting Standards Update
|
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Aziyo
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Aziyo Med, LLC
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CEO
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Chief Executive Officer
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Company
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Ligand Pharmaceuticals Incorporated, including subsidiaries
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CorMatrix
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CorMatrix Cardiovascular, Inc.
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CVR
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Contingent value right
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Crystal
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Crystal Bioscience, Inc.
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CyDex
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CyDex Pharmaceuticals, Inc.
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Amended ESPP
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Employee Stock Purchase Plan, as amended and restated
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FASB
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Financial Accounting Standards Board
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FDA
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Food and Drug Administration
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GAAP
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Generally accepted accounting principles in the United States
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IPR&D
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In-Process Research and Development
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Ligand
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Ligand Pharmaceuticals Incorporated, including subsidiaries
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LSA
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Loan and Security Agreement
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Metabasis
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Metabasis Therapeutics, Inc.
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MLA
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Master License Agreement
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NOLs
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Net Operating Losses
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OMT
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OMT, Inc. or Open Monoclonal Technology, Inc.
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Retrophin
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Retrophin Inc.
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Q3 2017
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The Company's fiscal quarter ended September 30, 2017
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Q3 2016
|
The Company's fiscal quarter ended September 30, 2016
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SEC
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Securities and Exchange Commission
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Selexis
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Selexis, SA
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Viking
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Viking Therapeutics
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FINANCIAL INFORMATION
|
|
ITEM 1.
|
FINANCIAL STATEMENTS
|
|
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September 30, 2017
|
|
December 31, 2016
|
||||
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ASSETS
|
|
|
|
||||
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Current assets:
|
|
|
|
||||
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Cash and cash equivalents
|
$
|
32,739
|
|
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$
|
18,752
|
|
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Short-term investments
|
169,520
|
|
|
122,296
|
|
||
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Accounts receivable
|
12,816
|
|
|
14,700
|
|
||
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Note receivable from Viking
|
3,007
|
|
|
3,207
|
|
||
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Inventory
|
5,007
|
|
|
1,923
|
|
||
|
Other current assets
|
1,112
|
|
|
2,175
|
|
||
|
Total current assets
|
224,201
|
|
|
163,053
|
|
||
|
Deferred income taxes
|
134,939
|
|
|
123,891
|
|
||
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Investment in Viking
|
5,137
|
|
|
8,345
|
|
||
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Intangible assets, net
|
196,578
|
|
|
204,705
|
|
||
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Goodwill
|
72,207
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|
|
72,207
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|
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Commercial license rights, net
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23,721
|
|
|
25,821
|
|
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Property and equipment, net
|
3,526
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|
|
1,819
|
|
||
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Other assets
|
2,028
|
|
|
1,744
|
|
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Total assets
|
$
|
662,337
|
|
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$
|
601,585
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
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Current liabilities:
|
|
|
|
||||
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Accounts payable
|
$
|
3,617
|
|
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$
|
2,734
|
|
|
Accrued liabilities
|
6,423
|
|
|
6,397
|
|
||
|
Current contingent liabilities
|
86
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|
|
5,088
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|
||
|
2019 Convertible Senior Notes, net
|
221,557
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|
|
212,910
|
|
||
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Total current liabilities
|
231,683
|
|
|
227,129
|
|
||
|
Long-term contingent liabilities
|
5,196
|
|
|
2,916
|
|
||
|
Other long-term liabilities
|
695
|
|
|
687
|
|
||
|
Total liabilities
|
237,574
|
|
|
230,732
|
|
||
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Commitments and Contingencies
|
|
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|
||||
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Equity component of currently redeemable convertible notes (Note 3)
|
21,597
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|
|
29,563
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|
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|
Stockholders' equity:
|
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|
||||
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Common stock, $0.001 par value; 33,333,333 shares authorized; 21,094,836 and 20,909,301 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively
|
21
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21
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Additional paid-in capital
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793,724
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769,653
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|
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Accumulated other comprehensive income
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3,335
|
|
|
2,743
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|
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Accumulated deficit
|
(393,914
|
)
|
|
(431,127
|
)
|
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Total stockholders' equity
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403,166
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|
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341,290
|
|
||
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Total liabilities and stockholders' equity
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$
|
662,337
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$
|
601,585
|
|
|
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Three months ended
|
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Nine months ended
|
||||||||||||
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September 30,
|
|
September 30,
|
||||||||||||
|
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2017
|
|
2016
|
|
2017
|
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2016
|
||||||||
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Revenues:
|
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|
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|
||||||||
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Royalties
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$
|
21,931
|
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$
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15,698
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|
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$
|
60,372
|
|
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$
|
39,842
|
|
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Material sales
|
7,664
|
|
|
4,219
|
|
|
14,336
|
|
|
13,445
|
|
||||
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License fees, milestones and other revenues
|
3,780
|
|
|
1,702
|
|
|
15,930
|
|
|
17,500
|
|
||||
|
Total revenues
|
33,375
|
|
|
21,619
|
|
|
90,638
|
|
|
70,787
|
|
||||
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
||||||||
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Cost of sales
(1)
|
2,385
|
|
|
999
|
|
|
3,628
|
|
|
2,674
|
|
||||
|
Amortization of intangibles
|
2,706
|
|
|
2,706
|
|
|
8,126
|
|
|
7,912
|
|
||||
|
Research and development
|
4,759
|
|
|
5,898
|
|
|
18,254
|
|
|
14,813
|
|
||||
|
General and administrative
|
7,032
|
|
|
6,550
|
|
|
20,904
|
|
|
20,858
|
|
||||
|
Total operating costs and expenses
|
16,882
|
|
|
16,153
|
|
|
50,912
|
|
|
46,257
|
|
||||
|
Income from operations
|
16,493
|
|
|
5,466
|
|
|
39,726
|
|
|
24,530
|
|
||||
|
Other (expense) income:
|
|
|
|
|
|
|
|
||||||||
|
Interest expense, net
|
(2,822
|
)
|
|
(3,116
|
)
|
|
(8,625
|
)
|
|
(9,172
|
)
|
||||
|
Increase in contingent liabilities
|
(1,336
|
)
|
|
(958
|
)
|
|
(2,302
|
)
|
|
(2,595
|
)
|
||||
|
Loss from Viking
|
(1,019
|
)
|
|
(1,396
|
)
|
|
(3,350
|
)
|
|
(14,139
|
)
|
||||
|
Other income, net
|
755
|
|
|
1,215
|
|
|
1,117
|
|
|
2,107
|
|
||||
|
Total other expense, net
|
(4,422
|
)
|
|
(4,255
|
)
|
|
(13,160
|
)
|
|
(23,799
|
)
|
||||
|
Income before income taxes
|
12,071
|
|
|
1,211
|
|
|
26,566
|
|
|
731
|
|
||||
|
Income tax (expense) benefit
|
(3,645
|
)
|
|
(160
|
)
|
|
(7,000
|
)
|
|
28
|
|
||||
|
Income from operations
|
8,426
|
|
|
1,051
|
|
|
19,566
|
|
|
759
|
|
||||
|
Discontinued operations:
|
|
|
|
|
|
|
|
||||||||
|
Gain on sale of Oncology Product Line before income taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
1,139
|
|
||||
|
Income tax expense on discontinued operations
|
—
|
|
|
—
|
|
|
—
|
|
|
(408
|
)
|
||||
|
Income from discontinued operations
|
—
|
|
|
—
|
|
|
—
|
|
|
731
|
|
||||
|
Net income
|
$
|
8,426
|
|
|
$
|
1,051
|
|
|
$
|
19,566
|
|
|
$
|
1,490
|
|
|
Per share amounts:
|
|
|
|
|
|
|
|
||||||||
|
Basic earnings per share data
(2)
|
|
|
|
|
|
|
|
||||||||
|
Income from continuing operations
|
$
|
0.40
|
|
|
$
|
0.05
|
|
|
$
|
0.93
|
|
|
$
|
0.04
|
|
|
Income from discontinued operations
|
—
|
|
|
—
|
|
|
—
|
|
|
0.04
|
|
||||
|
Net income
|
$
|
0.40
|
|
|
$
|
0.05
|
|
|
$
|
0.93
|
|
|
$
|
0.07
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Diluted earnings per share data
(2)
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Income from continuing operations
|
$
|
0.36
|
|
|
$
|
0.05
|
|
|
$
|
0.84
|
|
|
$
|
0.03
|
|
|
Income from discontinued operations
|
—
|
|
|
—
|
|
|
—
|
|
|
0.03
|
|
||||
|
Net income
|
$
|
0.36
|
|
|
$
|
0.05
|
|
|
$
|
0.84
|
|
|
$
|
0.07
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Shares used for computation (in thousands)
|
|
|
|
|
|
|
|
||||||||
|
Basic
|
21,071
|
|
|
20,887
|
|
|
21,007
|
|
|
20,806
|
|
||||
|
Diluted
|
23,551
|
|
|
22,997
|
|
|
23,262
|
|
|
22,742
|
|
||||
|
|
Three months ended
|
|
Nine months ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Net income:
|
$
|
8,426
|
|
|
$
|
1,051
|
|
|
$
|
19,566
|
|
|
$
|
1,490
|
|
|
Unrealized net gain on available-for-sale securities, net of tax
|
605
|
|
|
978
|
|
|
628
|
|
|
367
|
|
||||
|
Less: Reclassification of net realized gain included in net income, net of tax
|
(329
|
)
|
|
(1,071
|
)
|
|
(36
|
)
|
|
(1,670
|
)
|
||||
|
Comprehensive income
|
$
|
8,702
|
|
|
$
|
958
|
|
|
$
|
20,158
|
|
|
$
|
187
|
|
|
|
Nine months ended
|
||||||
|
|
September 30,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Operating activities
|
|
|
|
||||
|
Net income
|
$
|
19,566
|
|
|
$
|
1,490
|
|
|
Less: income from discontinued operations
|
—
|
|
|
731
|
|
||
|
Income from continuing operations
|
19,566
|
|
|
759
|
|
||
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
|
Non-cash change in estimated fair value of contingent liabilities
|
2,302
|
|
|
2,595
|
|
||
|
Realized gain on sale of short-term investment
|
(371
|
)
|
|
(1,776
|
)
|
||
|
Gain on disposal of assets
|
—
|
|
|
183
|
|
||
|
Depreciation and amortization
|
7,581
|
|
|
8,322
|
|
||
|
Amortization of premium (discount) on investments, net
|
88
|
|
|
510
|
|
||
|
Amortization of debt discount and issuance fees
|
8,647
|
|
|
8,130
|
|
||
|
Stock-based compensation
|
15,917
|
|
|
13,690
|
|
||
|
Deferred income taxes
|
6,855
|
|
|
347
|
|
||
|
Change in fair value of the Viking convertible debt receivable and warrants
|
(426
|
)
|
|
(464
|
)
|
||
|
Loss from equity method investment
|
3,350
|
|
|
14,139
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable
|
1,909
|
|
|
(411
|
)
|
||
|
Inventory
|
(1,985
|
)
|
|
(2,394
|
)
|
||
|
Other current assets
|
399
|
|
|
(9
|
)
|
||
|
Other long-term assets
|
—
|
|
|
(31
|
)
|
||
|
Accounts payable and accrued liabilities
|
(2,649
|
)
|
|
(3,079
|
)
|
||
|
Other
|
1,075
|
|
|
1,497
|
|
||
|
Net cash provided by operating activities
|
62,258
|
|
|
42,008
|
|
||
|
Investing activities
|
|
|
|
||||
|
Purchase of commercial license rights
|
—
|
|
|
(17,695
|
)
|
||
|
Payments to CVR holders and other contingency payments
|
(4,998
|
)
|
|
(7,055
|
)
|
||
|
Purchases of property and equipment
|
(220
|
)
|
|
(1,783
|
)
|
||
|
Cash paid for acquisition, net of cash acquired
|
—
|
|
|
(92,504
|
)
|
||
|
Purchase of short-term investments
|
(205,121
|
)
|
|
(73,109
|
)
|
||
|
Purchase of common stock in equity method investment
|
—
|
|
|
(1,000
|
)
|
||
|
Purchase of Viking common stock and warrants
|
—
|
|
|
(700
|
)
|
||
|
Proceeds received from repayment of Viking note receivable
|
200
|
|
|
300
|
|
||
|
Proceeds received from repayment of commercial license rights
|
2,859
|
|
|
—
|
|
||
|
Proceeds from sale of short-term investments
|
83,390
|
|
|
23,387
|
|
||
|
Proceeds from maturity of short-term investments
|
75,887
|
|
|
113,694
|
|
||
|
Net cash used in investing activities
|
(48,003
|
)
|
|
(56,465
|
)
|
||
|
Financing activities
|
|
|
|
||||
|
Net proceeds from stock option exercises and ESPP
|
3,864
|
|
|
4,608
|
|
||
|
Taxes paid related to net share settlement of equity awards
|
(4,132
|
)
|
|
(999
|
)
|
||
|
Net cash (used in) provided by financing activities
|
(268
|
)
|
|
3,609
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
13,987
|
|
|
(10,848
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
18,752
|
|
|
97,428
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
32,739
|
|
|
$
|
86,580
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
||||
|
Interest paid
|
$
|
1,838
|
|
|
$
|
1,838
|
|
|
Taxes paid
|
145
|
|
|
36
|
|
||
|
Supplemental schedule of non-cash activity
|
|
|
|
||||
|
Stock issued for acquisition, net of issuance cost
|
—
|
|
|
(77,330
|
)
|
||
|
Unsettled repurchase of common stock
|
—
|
|
|
(1,554
|
)
|
||
|
Stock and warrant received for repayment of Viking notes receivable
|
—
|
|
|
1,200
|
|
||
|
Accrued fixed asset purchases
|
1,700
|
|
|
—
|
|
||
|
Accrued inventory purchases
|
499
|
|
|
—
|
|
||
|
Unrealized gain (loss) on AFS investments
|
628
|
|
|
(271
|
)
|
||
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
|
Amortized cost
|
|
Gross unrealized
gains
|
|
Gross unrealized
losses
|
|
Estimated
fair value
|
|
Amortized cost
|
|
Gross unrealized
gains
|
|
Gross unrealized
losses
|
|
Estimated
fair value
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Bank deposits
|
$
|
77,307
|
|
|
$
|
12
|
|
|
$
|
(5
|
)
|
|
$
|
77,314
|
|
|
$
|
40,715
|
|
|
$
|
19
|
|
|
$
|
—
|
|
|
$
|
40,734
|
|
|
Corporate bonds
|
50,833
|
|
|
3
|
|
|
(34
|
)
|
|
50,802
|
|
|
11,031
|
|
|
—
|
|
|
(5
|
)
|
|
11,026
|
|
||||||||
|
Commercial paper
|
23,176
|
|
|
3
|
|
|
(2
|
)
|
|
23,177
|
|
|
33,074
|
|
|
2
|
|
|
(9
|
)
|
|
33,067
|
|
||||||||
|
U.S. Government bonds
|
8,490
|
|
|
2
|
|
|
(6
|
)
|
|
8,486
|
|
|
7,508
|
|
|
—
|
|
|
(1
|
)
|
|
7,507
|
|
||||||||
|
Agency bonds
|
4,977
|
|
|
—
|
|
|
—
|
|
|
4,977
|
|
|
7,294
|
|
|
1
|
|
|
—
|
|
|
7,295
|
|
||||||||
|
Municipal bonds
|
2,020
|
|
|
—
|
|
|
(8
|
)
|
|
2,012
|
|
|
19,624
|
|
|
—
|
|
|
(11
|
)
|
|
19,613
|
|
||||||||
|
Corporate equity securities
|
254
|
|
|
2,498
|
|
|
—
|
|
|
2,752
|
|
|
1,512
|
|
|
1,542
|
|
|
—
|
|
|
3,054
|
|
||||||||
|
|
$
|
167,057
|
|
|
$
|
2,518
|
|
|
$
|
(55
|
)
|
|
$
|
169,520
|
|
|
$
|
120,758
|
|
|
$
|
1,564
|
|
|
$
|
(26
|
)
|
|
$
|
122,296
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Indefinite lived intangible assets
|
|
|
|
||||
|
IPR&D
|
$
|
12,246
|
|
|
$
|
12,246
|
|
|
Goodwill
|
72,207
|
|
|
72,207
|
|
||
|
Definite lived intangible assets
|
|
|
|
||||
|
Complete technology
|
182,577
|
|
|
182,577
|
|
||
|
Less: Accumulated amortization
|
(19,710
|
)
|
|
(12,792
|
)
|
||
|
Trade name
|
2,642
|
|
|
2,642
|
|
||
|
Less: Accumulated amortization
|
(883
|
)
|
|
(784
|
)
|
||
|
Customer relationships
|
29,600
|
|
|
29,600
|
|
||
|
Less: Accumulated amortization
|
(9,894
|
)
|
|
(8,784
|
)
|
||
|
Total goodwill and other identifiable intangible assets, net
|
$
|
268,785
|
|
|
$
|
276,912
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
CorMatrix
|
$
|
15,190
|
|
|
$
|
17,284
|
|
|
Selexis
|
8,531
|
|
|
8,537
|
|
||
|
|
$
|
23,721
|
|
|
$
|
25,821
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Compensation
|
$
|
2,479
|
|
|
$
|
2,603
|
|
|
Professional fees
|
634
|
|
|
829
|
|
||
|
Amounts owed to former licensees
|
457
|
|
|
899
|
|
||
|
Royalties owed to third parties
|
1,000
|
|
|
942
|
|
||
|
Deferred revenue
|
1,075
|
|
|
—
|
|
||
|
Other
|
778
|
|
|
1,124
|
|
||
|
Total accrued liabilities
|
$
|
6,423
|
|
|
$
|
6,397
|
|
|
|
Three months ended
|
|
Nine months ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Stock-based compensation expense as a component of:
|
|
|
|
|
|
|
|
||||||||
|
Research and development expenses
|
$
|
2,394
|
|
|
$
|
2,845
|
|
|
$
|
8,260
|
|
|
$
|
6,112
|
|
|
General and administrative expenses
|
2,854
|
|
|
2,486
|
|
|
7,657
|
|
|
7,578
|
|
||||
|
|
$
|
5,248
|
|
|
$
|
5,331
|
|
|
$
|
15,917
|
|
|
$
|
13,690
|
|
|
|
Three months ended
|
|
Nine months ended
|
||||
|
|
September 30,
|
|
September 30,
|
||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
Risk-free interest rate
|
2.0%
|
|
1.3%
|
|
2.1%
|
|
1.5%
|
|
Dividend yield
|
—
|
|
—
|
|
—
|
|
—
|
|
Expected volatility
|
47%
|
|
49%
|
|
47%
|
|
50%
|
|
Expected term
|
6.5
|
|
6.7
|
|
6.8
|
|
6.6
|
|
|
Three months ended
|
|
Nine months ended
|
||||||||
|
|
September 30,
|
|
September 30,
|
||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||
|
Weighted average shares outstanding:
|
21,070,678
|
|
|
20,886,705
|
|
|
21,006,718
|
|
|
20,805,604
|
|
|
Dilutive potential common shares:
|
|
|
|
|
|
|
|
||||
|
Restricted stock
|
79,222
|
|
|
134,008
|
|
|
140,340
|
|
|
102,282
|
|
|
Stock options
|
1,019,342
|
|
|
792,474
|
|
|
980,461
|
|
|
788,106
|
|
|
2019 Convertible Senior Notes
|
1,334,357
|
|
|
1,184,092
|
|
|
1,118,456
|
|
|
1,046,257
|
|
|
Warrants
|
47,646
|
|
|
—
|
|
|
15,882
|
|
|
—
|
|
|
Shares used to compute diluted income per share
|
23,551,245
|
|
|
22,997,279
|
|
|
23,261,857
|
|
|
22,742,249
|
|
|
Potentially dilutive shares excluded from calculation due to anti-dilutive effect
|
255,101
|
|
|
3,540,806
|
|
|
2,531,219
|
|
|
3,522,063
|
|
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Short-term investments
(1)
|
|
$
|
2,753
|
|
|
$
|
166,767
|
|
|
$
|
—
|
|
|
$
|
169,520
|
|
|
$
|
3,054
|
|
|
$
|
119,242
|
|
|
$
|
—
|
|
|
$
|
122,296
|
|
|
Note receivable Viking
(2)
|
|
—
|
|
|
—
|
|
|
3,007
|
|
|
3,007
|
|
|
—
|
|
|
—
|
|
|
3,207
|
|
|
3,207
|
|
||||||||
|
Investment in warrants
(3)
|
|
1,110
|
|
|
—
|
|
|
—
|
|
|
1,110
|
|
|
684
|
|
|
—
|
|
|
—
|
|
|
684
|
|
||||||||
|
Total assets
|
|
$
|
3,863
|
|
|
$
|
166,767
|
|
|
$
|
3,007
|
|
|
$
|
173,637
|
|
|
$
|
3,738
|
|
|
$
|
119,242
|
|
|
$
|
3,207
|
|
|
$
|
126,187
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Current contingent liabilities-CyDex
(4)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
86
|
|
|
$
|
86
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
101
|
|
|
$
|
101
|
|
|
Long-term contingent liabilities-CyDex
(4)
|
|
—
|
|
|
—
|
|
|
1,503
|
|
|
1,503
|
|
|
—
|
|
|
—
|
|
|
1,503
|
|
|
1,503
|
|
||||||||
|
Long-term contingent liabilities-Metabasis
(5)
|
|
—
|
|
|
3,693
|
|
|
—
|
|
|
3,693
|
|
|
—
|
|
|
1,413
|
|
|
—
|
|
|
1,413
|
|
||||||||
|
Liability for amounts owed to former licensees
(6)
|
|
413
|
|
|
—
|
|
|
—
|
|
|
413
|
|
|
371
|
|
|
—
|
|
|
—
|
|
|
371
|
|
||||||||
|
Total liabilities
|
|
$
|
413
|
|
|
$
|
3,693
|
|
|
$
|
1,589
|
|
|
$
|
5,695
|
|
|
$
|
371
|
|
|
$
|
1,413
|
|
|
$
|
1,604
|
|
|
$
|
3,388
|
|
|
(1)
|
Investments in equity securities, which the Company received as a result of event-based and upfront payments from licensees, are classified as level 1 as the fair value is determined using quoted market prices in active markets for the same securities. Short-term investments in marketable securities with maturities greater than 90 days are classified as level 2 of the fair value hierarchy, as these investment securities are valued based upon quoted prices for identical or similar instruments in markets that are not active, and model-based valuation techniques for which all significant assumptions are observable in the market.
|
|
(2)
|
The fair value of the convertible note receivable from Viking was determined using a probability weighted option pricing model using a lattice methodology. The fair value is subjective and is affected by certain significant input to the valuation model such as the estimated volatility of the common stock, which was estimated to be
75%
at
September 30, 2017
. Changes in these assumptions may materially affect the fair value estimate.
|
|
(3)
|
Investment in warrants, which the Company received as a result of Viking’s partial repayment of the Viking note receivable and the Company’s purchase of Viking common stock and warrants in
April 2016
, are classified as level 1 as the fair value is determined using quoted market prices in active markets for the same securities. The change of the fair value is recorded in the other income or expenses in the Company's condensed consolidated statement of operations.
|
|
(4)
|
The fair value of the liabilities for CyDex contingent liabilities were determined based on the income approach. To the extent the estimated future income may vary significantly given the long-term nature of the estimate, the Company utilizes a Monte Carlo model. The fair value is subjective and is affected by changes in inputs to the valuation model including management’s estimates of timing and probability of achievement of certain revenue thresholds and developmental and regulatory milestones which may be achieved and affect amounts owed to former license holders. Changes in these assumptions can materially affect the fair value estimate.
|
|
(5)
|
The liability for CVRs for Metabasis are determined using quoted prices in a market that is not active for the underlying CVR.
|
|
(6)
|
The liability for amounts owed to former licensees are determined using quoted market prices in active markets for the underlying investment received from a partner, a portion of which is owed to former licensees.
|
|
|
September 30, 2017
|
|
December 31, 2016
|
|
Revenue volatility
|
25%
|
|
25%
|
|
Average probability of commercialization
|
12.5%
|
|
12.5%
|
|
Market price of risk
|
0.03
|
|
0.03
|
|
Credit rating
|
BB
|
|
BB
|
|
Equity risk premium
|
6%
|
|
6%
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
|
2019 Convertible Senior Notes
|
|
|
|
||||
|
Principal amount outstanding
|
$
|
245,000
|
|
|
$
|
245,000
|
|
|
Unamortized discount (including unamortized debt issuance cost)
|
(23,443
|
)
|
|
(32,090
|
)
|
||
|
Total current portion of notes payable
|
$
|
221,557
|
|
|
$
|
212,910
|
|
|
|
Stock Options
|
|
Restricted Stock Awards
|
||||||||||
|
|
Shares
|
|
Weighted-
Average
Exercise
Price
|
|
Shares
|
|
Weighted-
Average Grant
Date Fair Value
|
||||||
|
Balance as of December 31, 2016
|
1,754,275
|
|
|
$
|
42.12
|
|
|
308,700
|
|
|
$
|
86.61
|
|
|
Granted
|
202,553
|
|
|
102.43
|
|
|
69,064
|
|
|
101.97
|
|
||
|
Options exercised/RSUs vested
|
(120,823
|
)
|
|
31.85
|
|
|
(102,810
|
)
|
|
81.74
|
|
||
|
Forfeited
|
(3,044
|
)
|
|
79.74
|
|
|
(966
|
)
|
|
89.01
|
|
||
|
Balance as of September 30, 2017
|
1,832,961
|
|
|
$
|
49.41
|
|
|
273,988
|
|
|
$
|
92.30
|
|
|
ITEM 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
•
|
Novartis reported third quarter 2017 net sales of Promacta/Revolade (eltrombopag) of $227 million, a $59 million or 35% increase over the same period in 2016.
|
|
•
|
Novartis announced long-term study results supporting the positive safety and efficacy of Revolade (eltrombopag) in adults with chronic/persistent (6 or more months from diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published online in
Blood
. The EXTEND study found that a majority of patients maintained a substantial clinical response and many no longer needed concomitant ITP medications.
|
|
•
|
Novartis highlighted the product in abstracts for the upcoming 59th American Society of Hematology (ASH) annual meeting.
|
|
•
|
On October 25, 2017, Amgen reported third quarter net sales of Kyprolis (carfilzomib) of $207 million, a $24 million or 13% increase over the same period in 2016. On November 6, 2017, Ono Pharmaceutical Company reported Kyprolis sales in Japan of approximately $13.1 million for the most recent quarter.
|
|
•
|
On October 23, 2017, Amgen announced top-line results of the Phase 3 ARROW trial, which showed Kyprolis administered once-weekly at the 70 mg/m2 dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than Kyprolis administered twice-weekly at the 27 mg/m2 dose with dexamethasone.
|
|
•
|
On August 30, 2017, Amgen announced that the FDA accepted a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that Kyprolis and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade® (bortezomib)
|
|
•
|
On July 12, 2017, Amgen announced positive results from final analysis of the Phase 3 ASPIRE trial, showing the study met the key secondary endpoint of OS, demonstrating that Kyprolis, lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% over lenalidomide and dexamethasone alone.
|
|
•
|
Sage Therapeutics announced positive top-line results from two Phase 3 trials of brexanolone in severe postpartum depression (PPD) and in moderate PPD. Sage plans to file a New Drug Application (NDA) with the FDA in 2018.
|
|
•
|
Spectrum Pharmaceuticals reported third quarter 2017 net sales of EVOMELA of $10.5 million.
|
|
•
|
CASI Pharmaceuticals announced that China’s Food and Drug Administration granted priority review for CASI’s import drug registration clinical trial application for EVOMELA.
|
|
•
|
Melinta Therapeutics announced a merger with NASDAQ-listed Cempra, Inc. to form a company focused on developing and commercializing important anti-infective therapies including recently-approved Baxdela.
|
|
•
|
Melinta Therapeutics announced that its commercialization and distribution agreement with Eurofarma Laboratórios for delafloxacin (Baxdela in the U.S.) had been expanded to include 19 countries in South and Central America and the Caribbean.
|
|
•
|
Zydus Cadila announced that it received approval to market its bevacizumab biosimilar in India and subsequently launched the drug, which is marketed as Bryxta.
|
|
•
|
Exelixis announced that Daiichi Sankyo reported positive top-line results from a phase 3 pivotal trial of esaxerenone in patients with essential hypertension in Japan and that a Japanese regulatory application is expected to be submitted in the first quarter of 2018.
|
|
•
|
Retrophin announced that it presented new data from the open label extension portion of the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology Kidney Week 2017.
|
|
•
|
Aldeyra Therapeutics announced positive results from a Phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease.
|
|
•
|
Aldeyra Therapeutics announced it will present data from its Phase 2 clinical trial in noninfectious anterior uveitis at the American Uveitis Society Fall Meeting.
|
|
•
|
Viking Therapeutics announced enrollment completion in the ongoing Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture.
|
|
•
|
Viking Therapeutics announced results of gene expression analysis from its
in vivo
study of VK2809 in Non-Alcoholic Steatohepatitis (NASH) and presented data at the Annual Meeting of the American Association for the Study of Liver Diseases.
|
|
•
|
Viking Therapeutics announced presentation of data from an
in vivo
proof-of-concept study of VK2809 in Glycogen Storage Disease Ia at the 13th International Congress of Inborn Errors of Metabolism.
|
|
•
|
Viking Therapeutics announced positive top-line results from a 25-week proof-of-concept study of VK0214 in an in vivo model of X-linked adrenoleukodystrophy (X-ALD) and presented data at the 87th Annual Meeting of the American Thyroid Association.
|
|
•
|
Sermonix Pharmaceuticals announced completion of a financing round to fund a Phase 2 clinical trial of lasofoxifene in Estrogen Receptor Positive (ER+) Metastatic Breast Cancer.
|
|
•
|
Opthea announced further positive results from its Phase 1/2a clinical trial of OPT-302 for wet age-related macular degeneration (wet AMD).
|
|
•
|
CStone Pharmaceuticals announced that it received Clinical Trial Application approval from the China Food and Drug Administration to conduct clinical trials in China with CS1001, an OmniAb-derived full-length anti-PDL1 monoclonal antibody.
|
|
•
|
Aptevo Therapeutics announced that it had presented new preclinical data on OmniAb-derived APVO436 at the World Bispecific Summit and also at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics 2017 annual meeting.
|
|
•
|
HanAll Biopharma, an OmniAb partner, announced entering into a strategic collaboration with Harbour BioMed to develop novel biologic therapies in greater China.
|
|
•
|
ARMO BioSciences, an OmniAb partner, announced a $67 million Series C-1 financing to fund their immunotherapy pipeline.
|
|
•
|
Immunoprecise Antibodies, an OmniAb Contract Research Organization (CRO), announced recent success in conducting OmniAb antibody-generation projects for Aptevo Therapeutics and Tizona Therapeutics.
|
|
•
|
A paper was published by Ligand scientists in the journal MAbs, entitled "Chickens with humanized immunoglobulin genes generate antibodies with high affinity and broad epitope coverage to conserved targets", highlighting the use of OmniChicken in antibody drug discovery.
|
|
•
|
In September 2017, Ligand presented positive top-line results from its Phase 2 clinical study evaluating the efficacy and safety of LGD-6972, as an adjunct to diet and exercise, in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin monotherapy. The study achieved statistical significance (p < 0.0001) in the primary endpoint of change from baseline in hemoglobin A1c (HbA1c) after 12 weeks of treatment at all doses tested, demonstrating a robust, dose-dependent reduction in HbA1c of 0.90%, 0.92% and 1.20% with 5 mg, 10 mg and 15 mg of LGD-6972, respectively, compared to a 0.15% reduction with placebo. LGD-6972 was safe and well tolerated, with no drug-related serious adverse events and no dose dependent changes in lipids (including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides), body weight or blood pressure after 12 weeks of treatment.
|
|
•
|
Ligand announced receipt of a $2 million payment from WuXi Biologics subsequent to their licensing of exclusive rights to the anti-PD-1 antibody GLS-010 to Arcus Biosciences in North America, Europe, Japan and certain other territories. Ligand is also entitled to future milestones and royalties from this antibody.
|
|
•
|
Ligand announced a commercial license and supply agreement with Amgen granting rights to use Captisol in the formulation of AMG 330, an anti-CD33 x anti-CD3 (BiTE®) bispecific antibody construct. Ligand is eligible to receive milestone payments, royalties and revenue from Captisol material sales related to AMG 330.
|
|
•
|
Ligand entered into Captisol Clinical Use Agreements with both Syros Pharmaceuticals and Vaxxas Inc.
|
|
•
|
In October 2017, Ligand acquired Crystal Bioscience and its OmniChicken antibody discovery technology for $25 million cash at closing, up to $10.5 million of success-based milestones and revenue sharing from existing licensees for a defined period. The acquisition initially added four Shots on Goal to Ligand’s portfolio, and the OmniChicken technology may be utilized by multiple current OmniAb partners as they seek to develop antibodies for difficult-to-address epitopes.
|
|
(Dollars in thousands)
|
Q3 2017
|
|
Q3 2016
|
|
Change
|
|
% Change
|
|
|
YTD 2017
|
|
YTD 2016
|
|
Change
|
|
% Change
|
||||||||||||||
|
Royalties
|
$
|
21,931
|
|
|
$
|
15,698
|
|
|
$
|
6,233
|
|
|
40
|
%
|
|
|
$
|
60,372
|
|
|
$
|
39,842
|
|
|
$
|
20,530
|
|
|
52
|
%
|
|
Material sales
|
7,664
|
|
|
4,219
|
|
|
3,445
|
|
|
82
|
%
|
|
|
14,336
|
|
|
13,445
|
|
|
891
|
|
|
7
|
%
|
||||||
|
License fees, milestones and other revenue
|
3,780
|
|
|
1,702
|
|
|
2,078
|
|
|
122
|
%
|
|
|
15,930
|
|
|
17,500
|
|
|
(1,570
|
)
|
|
(9
|
)%
|
||||||
|
Total revenue
|
$
|
33,375
|
|
|
$
|
21,619
|
|
|
$
|
11,756
|
|
|
54
|
%
|
|
|
$
|
90,638
|
|
|
$
|
70,787
|
|
|
$
|
19,851
|
|
|
28
|
%
|
|
(Dollars in thousands)
|
Q3 2017
|
|
% of Revenue
|
|
Q3 2016
|
|
% of Revenue
|
|
YTD 2017
|
|
% of Revenue
|
|
YTD 2016
|
|
% of Revenue
|
||||||||
|
Costs of sales
|
$
|
2,385
|
|
|
|
|
$
|
999
|
|
|
|
|
$
|
3,628
|
|
|
|
|
$
|
2,674
|
|
|
|
|
Amortization of intangibles
|
2,706
|
|
|
|
|
2,706
|
|
|
|
|
8,126
|
|
|
|
|
7,912
|
|
|
|
||||
|
Research and development
|
4,759
|
|
|
|
|
5,898
|
|
|
|
|
18,254
|
|
|
|
|
14,813
|
|
|
|
||||
|
General and administrative
|
7,032
|
|
|
|
|
6,550
|
|
|
|
|
20,904
|
|
|
|
|
20,858
|
|
|
|
||||
|
Total operating costs and expenses
|
$
|
16,882
|
|
|
51%
|
|
$
|
16,153
|
|
|
75%
|
|
$
|
50,912
|
|
|
56%
|
|
$
|
46,257
|
|
|
65%
|
|
(Dollars in thousands)
|
Q3 2017
|
|
Q3 2016
|
|
Change
|
|
|
YTD 2017
|
|
YTD 2016
|
|
Change
|
||||||||||||
|
Interest expense, net
|
$
|
(2,822
|
)
|
|
$
|
(3,116
|
)
|
|
$
|
294
|
|
|
|
$
|
(8,625
|
)
|
|
$
|
(9,172
|
)
|
|
$
|
547
|
|
|
Increase in contingent liabilities
|
(1,336
|
)
|
|
(958
|
)
|
|
(378
|
)
|
|
|
(2,302
|
)
|
|
(2,595
|
)
|
|
293
|
|
||||||
|
Loss from Viking
|
(1,019
|
)
|
|
(1,396
|
)
|
|
377
|
|
|
|
(3,350
|
)
|
|
(14,139
|
)
|
|
10,789
|
|
||||||
|
Other income, net
|
755
|
|
|
1,215
|
|
|
(460
|
)
|
|
|
1,117
|
|
|
2,107
|
|
|
(990
|
)
|
||||||
|
Total other expense, net
|
$
|
(4,422
|
)
|
|
$
|
(4,255
|
)
|
|
$
|
(167
|
)
|
|
|
$
|
(13,160
|
)
|
|
$
|
(23,799
|
)
|
|
$
|
10,639
|
|
|
(Dollars in thousands)
|
Q3 2017
|
|
Q3 2016
|
|
Change
|
|
|
YTD 2017
|
|
YTD 2016
|
|
Change
|
||||||||||||
|
Income before income taxes
|
$
|
12,071
|
|
|
$
|
1,211
|
|
|
$
|
10,860
|
|
|
|
$
|
26,566
|
|
|
$
|
731
|
|
|
$
|
25,835
|
|
|
Income tax expense
|
(3,645
|
)
|
|
(160
|
)
|
|
(3,485
|
)
|
|
|
(7,000
|
)
|
|
28
|
|
|
(7,028
|
)
|
||||||
|
Income from operations
|
$
|
8,426
|
|
|
$
|
1,051
|
|
|
$
|
7,375
|
|
|
|
$
|
19,566
|
|
|
$
|
759
|
|
|
$
|
18,807
|
|
|
Effective tax rate
|
30.2
|
%
|
|
13.2
|
%
|
|
|
|
|
|
26.3
|
%
|
|
(3.8
|
)%
|
|
|
|
||||||
|
(Dollars in thousands)
|
YTD 2017
|
|
YTD 2016
|
||||
|
Net cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
62,258
|
|
|
$
|
42,008
|
|
|
Investing activities
|
(48,003
|
)
|
|
(56,465
|
)
|
||
|
Financing activities
|
(268
|
)
|
|
3,609
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
$
|
13,987
|
|
|
$
|
(10,848
|
)
|
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
|
•
|
engagement of additional independent third party tax experts to assist or review in the tax accounting for non-routine, complex transactions or provide any acceptable alternative practice on the same transaction
|
|
•
|
additional training for staff involved in the tax accounting for non-routine, complex transactions
|
|
|
OTHER INFORMATION
|
|
ITEM 1A.
|
RISK FACTORS
|
|
ITEM 6.
|
EXHIBITS
|
|
Date:
|
November 9, 2017
|
|
By:
|
/s/ Matthew Korenberg
|
|
|
|
|
|
Matthew Korenberg
|
|
|
|
|
|
Vice President, Finance and Chief Financial Officer
|
|
|
|
|
|
Duly Authorized Officer and Principal Financial Officer
|
|
Exhibit Number
|
Description
|
|
|
|
|
Certification by Principal Executive Officer, Pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
Certification by Principal Financial Officer, Pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
Certifications by Principal Executive Officer and Principal Financial Officer, Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
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
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|