x
|
Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934
|
o
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
Delaware
|
77-0160744
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
3911 Sorrento Valley Boulevard, Suite 110 San Diego, CA
|
92121
(Zip Code)
|
(Address of principal executive offices)
|
|
Large Accelerated Filer
|
x
|
|
Accelerated Filer
|
o
|
Non-Accelerated Filer
|
o
|
(Do not check if a smaller reporting company)
|
Smaller Reporting Company
|
o
|
Emerging Growth Company
|
o
|
|
|
|
PART I. FINANCIAL INFORMATION
|
|
|
|
ITEM 1. Financial Statements
(Unaudited)
|
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
PART II. OTHER INFORMATION
|
|
|
|
||
|
||
|
|
|
|
GLOSSARY OF TERMS AND ABBREVIATIONS
|
|
Abbreviation
|
Definition
|
2019 Convertible Senior Notes
|
$245.0 million aggregate principal amount of convertible senior unsecured notes due 2019
|
Amgen
|
Amgen, Inc.
|
ASC
|
Accounting Standards Codification
|
ASU
|
Accounting Standards Update
|
Aziyo
|
Aziyo Med, LLC
|
Company
|
Ligand Pharmaceuticals Incorporated, including subsidiaries
|
CorMatrix
|
CorMatrix Cardiovascular, Inc.
|
CVR
|
Contingent value right
|
CyDex
|
CyDex Pharmaceuticals, Inc.
|
Amended ESPP
|
Employee Stock Purchase Plan, as amended and restated
|
FASB
|
Financial Accounting Standards Board
|
FDA
|
Food and Drug Administration
|
GAAP
|
Generally accepted accounting principles in the United States
|
IPR&D
|
In-Process Research and Development
|
Ligand
|
Ligand Pharmaceuticals Incorporated, including subsidiaries
|
LSA
|
Loan and Security Agreement
|
Metabasis
|
Metabasis Therapeutics, Inc.
|
MLA
|
Master License Agreement
|
NOLs
|
Net Operating Losses
|
OMT
|
OMT, Inc. or Open Monoclonal Technology, Inc.
|
Par
|
Par Pharmaceuticals, Inc.
|
Retrophin
|
Retrophin Inc.
|
Q2 2017
|
The Company's fiscal quarter ended June 30, 2017
|
Q2 2016
|
The Company's fiscal quarter ended June 30, 2016
|
SEC
|
Securities and Exchange Commission
|
Selexis
|
Selexis, SA
|
Viking
|
Viking Therapeutics
|
PART I.
|
FINANCIAL INFORMATION
|
ITEM 1.
|
FINANCIAL STATEMENTS
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
60,223
|
|
|
$
|
18,752
|
|
Short-term investments
|
112,404
|
|
|
122,296
|
|
||
Accounts receivable
|
13,462
|
|
|
14,700
|
|
||
Note receivable from Viking
|
3,207
|
|
|
3,207
|
|
||
Inventory
|
6,809
|
|
|
1,923
|
|
||
Other current assets
|
1,072
|
|
|
2,175
|
|
||
Total current assets
|
197,177
|
|
|
163,053
|
|
||
Deferred income taxes
|
138,837
|
|
|
123,891
|
|
||
Investment in Viking
|
6,014
|
|
|
8,345
|
|
||
Intangible assets, net
|
199,284
|
|
|
204,705
|
|
||
Goodwill
|
72,207
|
|
|
72,207
|
|
||
Commercial license rights, net
|
22,962
|
|
|
25,821
|
|
||
Property and equipment, net
|
1,875
|
|
|
1,819
|
|
||
Other assets
|
1,668
|
|
|
1,744
|
|
||
Total assets
|
$
|
640,024
|
|
|
$
|
601,585
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,799
|
|
|
$
|
2,734
|
|
Accrued liabilities
|
5,325
|
|
|
6,397
|
|
||
Current contingent liabilities
|
86
|
|
|
5,088
|
|
||
2019 Convertible Senior Notes, net
|
218,630
|
|
|
212,910
|
|
||
Total current liabilities
|
225,840
|
|
|
227,129
|
|
||
Long-term contingent liabilities
|
3,860
|
|
|
2,916
|
|
||
Other long-term liabilities
|
915
|
|
|
687
|
|
||
Total liabilities
|
230,615
|
|
|
230,732
|
|
||
Commitments and Contingencies
|
|
|
|
||||
Equity component of currently redeemable convertible notes (Note 5)
|
24,293
|
|
|
29,563
|
|
||
Stockholders' equity:
|
|
|
|
||||
Common stock, $0.001 par value; 33,333,333 shares authorized; 21,049,741 and 20,909,301 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
21
|
|
|
21
|
|
||
Additional paid-in capital
|
784,376
|
|
|
769,653
|
|
||
Accumulated other comprehensive income
|
3,059
|
|
|
2,743
|
|
||
Accumulated deficit
|
(402,340
|
)
|
|
(431,127
|
)
|
||
Total stockholders' equity
|
385,116
|
|
|
341,290
|
|
||
Total liabilities and stockholders' equity
|
$
|
640,024
|
|
|
$
|
601,585
|
|
|
Three months ended
|
|
Six months ended
|
||||||||||||
|
June 30,
|
|
June 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Royalties
|
$
|
14,211
|
|
|
$
|
9,754
|
|
|
$
|
38,441
|
|
|
$
|
24,144
|
|
Material sales
|
5,550
|
|
|
3,886
|
|
|
6,672
|
|
|
9,227
|
|
||||
License fees, milestones and other revenues
|
8,234
|
|
|
5,881
|
|
|
12,151
|
|
|
15,798
|
|
||||
Total revenues
|
27,995
|
|
|
19,521
|
|
|
57,264
|
|
|
49,169
|
|
||||
Operating costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of sales
(1)
|
903
|
|
|
720
|
|
|
1,244
|
|
|
1,675
|
|
||||
Amortization of intangibles
|
2,706
|
|
|
2,681
|
|
|
5,420
|
|
|
5,206
|
|
||||
Research and development
|
4,822
|
|
|
4,914
|
|
|
13,495
|
|
|
8,915
|
|
||||
General and administrative
|
6,549
|
|
|
7,237
|
|
|
13,872
|
|
|
14,309
|
|
||||
Total operating costs and expenses
|
14,980
|
|
|
15,552
|
|
|
34,031
|
|
|
30,105
|
|
||||
Income from operations
|
13,015
|
|
|
3,969
|
|
|
23,233
|
|
|
19,064
|
|
||||
Other (expense) income:
|
|
|
|
|
|
|
|
||||||||
Interest expense, net
|
(2,860
|
)
|
|
(3,051
|
)
|
|
(5,803
|
)
|
|
(6,055
|
)
|
||||
Increase in contingent liabilities
|
(825
|
)
|
|
(332
|
)
|
|
(966
|
)
|
|
(1,638
|
)
|
||||
Loss from Viking
|
(1,248
|
)
|
|
(11,138
|
)
|
|
(2,330
|
)
|
|
(12,743
|
)
|
||||
Other income, net
|
218
|
|
|
501
|
|
|
359
|
|
|
892
|
|
||||
Total other expense, net
|
(4,715
|
)
|
|
(14,020
|
)
|
|
(8,740
|
)
|
|
(19,544
|
)
|
||||
Income before income taxes
|
8,300
|
|
|
(10,051
|
)
|
|
14,493
|
|
|
(480
|
)
|
||||
Income tax (expense) benefit
|
(2,242
|
)
|
|
3,881
|
|
|
(3,356
|
)
|
|
187
|
|
||||
Income (loss) from operations
|
6,058
|
|
|
(6,170
|
)
|
|
11,137
|
|
|
(293
|
)
|
||||
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 (loss)
|
$
|
6,058
|
|
|
$
|
(6,170
|
)
|
|
$
|
11,137
|
|
|
$
|
438
|
|
Per share amounts:
|
|
|
|
|
|
|
|
||||||||
Basic earnings (loss) per share data
(2)
|
|
|
|
|
|
|
|
||||||||
Income (loss) from continuing operations
|
$
|
0.29
|
|
|
$
|
(0.30
|
)
|
|
$
|
0.53
|
|
|
$
|
(0.01
|
)
|
Income from discontinued operations
|
—
|
|
|
—
|
|
|
—
|
|
|
0.04
|
|
||||
Net income (loss)
|
$
|
0.29
|
|
|
$
|
(0.30
|
)
|
|
$
|
0.53
|
|
|
$
|
0.02
|
|
|
|
|
|
|
|
|
|
||||||||
Diluted earnings per share data
(2)
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income (loss) from continuing operations
|
$
|
0.26
|
|
|
$
|
(0.30
|
)
|
|
$
|
0.48
|
|
|
$
|
(0.01
|
)
|
Income from discontinued operations
|
—
|
|
|
—
|
|
|
—
|
|
|
0.04
|
|
||||
Net income (loss)
|
$
|
0.26
|
|
|
$
|
(0.30
|
)
|
|
$
|
0.48
|
|
|
$
|
0.02
|
|
|
|
|
|
|
|
|
|
||||||||
Shares used for computation (in thousands)
|
|
|
|
|
|
|
|
||||||||
Basic
|
21,013
|
|
|
20,832
|
|
|
20,975
|
|
|
20,765
|
|
||||
Diluted
|
23,216
|
|
|
20,832
|
|
|
23,117
|
|
|
20,765
|
|
|
Three months ended
|
|
Six months ended
|
||||||||||||
|
June 30,
|
|
June 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net income (loss) :
|
$
|
6,058
|
|
|
$
|
(6,170
|
)
|
|
$
|
11,137
|
|
|
$
|
438
|
|
Unrealized net gain/(loss) on available-for-sale securities, net of tax
|
90
|
|
|
539
|
|
|
24
|
|
|
(559
|
)
|
||||
Less: Reclassification of net realized (gain)/loss included in net income, net of tax
|
(136
|
)
|
|
(364
|
)
|
|
292
|
|
|
(600
|
)
|
||||
Comprehensive income (loss)
|
$
|
6,012
|
|
|
$
|
(5,995
|
)
|
|
$
|
11,453
|
|
|
$
|
(721
|
)
|
|
Six months ended
|
||||||
|
June 30,
|
||||||
|
2017
|
|
2016
|
||||
Operating activities
|
|
|
|
||||
Net income
|
$
|
11,137
|
|
|
$
|
438
|
|
Less: income from discontinued operations
|
—
|
|
|
731
|
|
||
Income (loss) from continuing operations
|
11,137
|
|
|
(293
|
)
|
||
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
Non-cash change in estimated fair value of contingent liabilities
|
966
|
|
|
1,638
|
|
||
Realized gain on sale of short-term investment
|
(248
|
)
|
|
(602
|
)
|
||
Depreciation and amortization
|
5,564
|
|
|
5,388
|
|
||
Amortization of premium (discount) on investments, net
|
(44
|
)
|
|
331
|
|
||
Amortization of debt discount and issuance fees
|
5,720
|
|
|
5,378
|
|
||
Stock-based compensation
|
10,669
|
|
|
8,766
|
|
||
Deferred income taxes
|
3,224
|
|
|
187
|
|
||
Change in fair value of the Viking convertible debt receivable and warrants
|
77
|
|
|
(310
|
)
|
||
Loss from Viking
|
2,330
|
|
|
12,743
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
1,263
|
|
|
(3,791
|
)
|
||
Inventory
|
(4,286
|
)
|
|
(2,202
|
)
|
||
Other current assets
|
314
|
|
|
(629
|
)
|
||
Accounts payable and accrued liabilities
|
(2,153
|
)
|
|
(3,323
|
)
|
||
Other
|
75
|
|
|
204
|
|
||
Net cash provided by operating activities
|
34,608
|
|
|
23,485
|
|
||
Investing activities
|
|
|
|
||||
Purchase of commercial license rights
|
—
|
|
|
(17,691
|
)
|
||
Payments to CVR holders and other contingency payments
|
(4,998
|
)
|
|
(5,635
|
)
|
||
Purchases of property and equipment
|
(199
|
)
|
|
(1,021
|
)
|
||
Cash paid for acquisition, net of cash acquired
|
—
|
|
|
(92,504
|
)
|
||
Purchase of short-term investments
|
(124,282
|
)
|
|
(49,892
|
)
|
||
Purchase of Viking common stock and warrants
|
—
|
|
|
(700
|
)
|
||
Proceeds received from repayment of Viking note receivable
|
—
|
|
|
300
|
|
||
Proceeds received from repayment of commercial license rights
|
2,859
|
|
|
—
|
|
||
Proceeds from sale of short-term investments
|
83,268
|
|
|
22,077
|
|
||
Proceeds from maturity of short-term investments
|
51,887
|
|
|
83,523
|
|
||
Net cash provided (used) in investing activities
|
8,535
|
|
|
(61,543
|
)
|
||
Financing activities
|
|
|
|
||||
Net proceeds from stock option exercises and ESPP
|
2,370
|
|
|
2,482
|
|
||
Taxes paid related to net share settlement of equity awards
|
(4,042
|
)
|
|
—
|
|
||
Share repurchase
|
—
|
|
|
(502
|
)
|
||
Net cash (used in) provided by financing activities
|
(1,672
|
)
|
|
1,980
|
|
||
Net increase (decrease) in cash and cash equivalents
|
41,471
|
|
|
(36,078
|
)
|
||
Cash and cash equivalents at beginning of period
|
18,752
|
|
|
97,428
|
|
||
Cash and cash equivalents at end of period
|
$
|
60,223
|
|
|
$
|
61,350
|
|
Supplemental disclosure of cash flow information
|
|
|
|
||||
Interest paid
|
$
|
919
|
|
|
$
|
919
|
|
Taxes paid
|
132
|
|
|
36
|
|
||
Supplemental schedule of non-cash activity
|
|
|
|
||||
Stock issued for acquisition, net of issuance cost
|
—
|
|
|
(77,615
|
)
|
||
Stock and warrant received for repayment of Viking notes receivable
|
—
|
|
|
1,200
|
|
||
Unrealized gain (loss) on AFS investments
|
24
|
|
|
(1,198
|
)
|
|
June 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
|
$
|
55,847
|
|
|
$
|
12
|
|
|
$
|
(9
|
)
|
|
$
|
55,850
|
|
|
$
|
40,715
|
|
|
$
|
19
|
|
|
$
|
—
|
|
|
$
|
40,734
|
|
Corporate bonds
|
30,043
|
|
|
2
|
|
|
(24
|
)
|
|
30,021
|
|
|
11,031
|
|
|
—
|
|
|
(5
|
)
|
|
11,026
|
|
||||||||
Commercial paper
|
13,948
|
|
|
—
|
|
|
(3
|
)
|
|
13,945
|
|
|
33,074
|
|
|
2
|
|
|
(9
|
)
|
|
33,067
|
|
||||||||
Agency bonds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,294
|
|
|
1
|
|
|
—
|
|
|
7,295
|
|
||||||||
U.S Government Bonds
|
8,474
|
|
|
—
|
|
|
(8
|
)
|
|
8,466
|
|
|
7,508
|
|
|
—
|
|
|
(1
|
)
|
|
7,507
|
|
||||||||
Municipal Bonds
|
1,784
|
|
|
—
|
|
|
—
|
|
|
1,784
|
|
|
19,624
|
|
|
—
|
|
|
(11
|
)
|
|
19,613
|
|
||||||||
Corporate equity securities
|
287
|
|
|
2,051
|
|
|
—
|
|
|
2,338
|
|
|
1,512
|
|
|
1,542
|
|
|
—
|
|
|
3,054
|
|
||||||||
|
$
|
110,383
|
|
|
$
|
2,065
|
|
|
$
|
(44
|
)
|
|
$
|
112,404
|
|
|
$
|
120,758
|
|
|
$
|
1,564
|
|
|
$
|
(26
|
)
|
|
$
|
122,296
|
|
|
June 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
|
(17,407
|
)
|
|
(12,792
|
)
|
||
Trade name
|
2,642
|
|
|
2,642
|
|
||
Less: Accumulated amortization
|
(850
|
)
|
|
(784
|
)
|
||
Customer relationships
|
29,600
|
|
|
29,600
|
|
||
Less: Accumulated amortization
|
(9,524
|
)
|
|
(8,784
|
)
|
||
Total goodwill and other identifiable intangible assets, net
|
$
|
271,491
|
|
|
$
|
276,912
|
|
|
June 30,
|
|
December 31,
|
||||
|
2017
|
|
2016
|
||||
CorMatrix
|
$
|
14,431
|
|
|
$
|
17,284
|
|
Selexis
|
8,531
|
|
|
8,537
|
|
||
|
22,962
|
|
|
25,821
|
|
|
June 30,
|
|
December 31,
|
||||
|
2017
|
|
2016
|
||||
Compensation
|
$
|
1,878
|
|
|
$
|
2,603
|
|
Professional fees
|
448
|
|
|
829
|
|
||
Amounts owed to former licensees
|
853
|
|
|
899
|
|
||
Royalties owed to third parties
|
908
|
|
|
942
|
|
||
Other
|
1,238
|
|
|
1,124
|
|
||
Total accrued liabilities
|
$
|
5,325
|
|
|
$
|
6,397
|
|
|
Three months ended
|
|
Six months ended
|
||||||||||||
|
June 30,
|
|
June 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Stock-based compensation expense as a component of:
|
|
|
|
|
|
|
|
||||||||
Research and development expenses
|
$
|
1,928
|
|
|
$
|
2,089
|
|
|
$
|
5,867
|
|
|
$
|
3,674
|
|
General and administrative expenses
|
2,696
|
|
|
2,558
|
|
|
4,802
|
|
|
5,092
|
|
||||
|
$
|
4,624
|
|
|
$
|
4,647
|
|
|
$
|
10,669
|
|
|
$
|
8,766
|
|
|
Three months ended
|
|
Six months ended
|
||||
|
June 30,
|
|
June 30,
|
||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Risk-free interest rate
|
2.1%
|
|
1.7%
|
|
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
|
|
Six months ended
|
||||||||
|
June 30,
|
|
June 30,
|
||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||
Weighted average shares outstanding:
|
21,012,611
|
|
|
20,831,809
|
|
|
20,974,738
|
|
|
20,765,053
|
|
Dilutive potential common shares:
|
|
|
|
|
|
|
|
||||
Restricted stock
|
156,054
|
|
|
—
|
|
|
170,900
|
|
|
—
|
|
Stock options
|
967,533
|
|
|
—
|
|
|
961,021
|
|
|
—
|
|
2019 Convertible Senior Notes
|
1,079,702
|
|
|
—
|
|
|
1,010,505
|
|
|
—
|
|
Shares used to compute diluted income per share
|
23,215,900
|
|
|
20,831,809
|
|
|
23,117,164
|
|
|
20,765,053
|
|
Potentially dilutive shares excluded from calculation due to anti-dilutive effect
|
3,811,813
|
|
|
—
|
|
|
3,761,440
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Short-term investments
(1)
|
|
$
|
2,338
|
|
|
$
|
110,066
|
|
|
$
|
—
|
|
|
$
|
112,404
|
|
|
$
|
3,054
|
|
|
$
|
119,242
|
|
|
$
|
—
|
|
|
$
|
122,296
|
|
Note receivable Viking
(2)
|
|
—
|
|
|
—
|
|
|
3,207
|
|
|
3,207
|
|
|
—
|
|
|
—
|
|
|
3,207
|
|
|
3,207
|
|
||||||||
Investment in warrants
(3)
|
|
608
|
|
|
—
|
|
|
—
|
|
|
608
|
|
|
684
|
|
|
—
|
|
|
—
|
|
|
684
|
|
||||||||
Total assets
|
|
$
|
2,946
|
|
|
$
|
110,066
|
|
|
$
|
3,207
|
|
|
$
|
116,219
|
|
|
$
|
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)
|
|
—
|
|
|
2,357
|
|
|
—
|
|
|
2,357
|
|
|
—
|
|
|
1,413
|
|
|
—
|
|
|
1,413
|
|
||||||||
Liability for amounts owed to former licensees
(6)
|
|
351
|
|
|
—
|
|
|
—
|
|
|
351
|
|
|
371
|
|
|
—
|
|
|
—
|
|
|
371
|
|
||||||||
Total liabilities
|
|
$
|
351
|
|
|
$
|
2,357
|
|
|
$
|
1,589
|
|
|
$
|
4,297
|
|
|
$
|
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
June 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.
|
|
June 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%
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
2019 Convertible Senior Notes
|
|
|
|
||||
Principal amount outstanding
|
$
|
245,000
|
|
|
$
|
245,000
|
|
Unamortized discount (including unamortized debt issuance cost)
|
(26,370
|
)
|
|
(32,090
|
)
|
||
Total current portion of notes payable
|
$
|
218,630
|
|
|
$
|
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
|
198,101
|
|
|
101.93
|
|
|
68,151
|
|
|
101.64
|
|
||
Options exercised/RSUs vested
|
(80,872
|
)
|
|
29.11
|
|
|
(100,476
|
)
|
|
81.15
|
|
||
Forfeited
|
—
|
|
|
—
|
|
|
(300
|
)
|
|
97.92
|
|
||
Balance as of June 30, 2017
|
1,871,504
|
|
|
$
|
49.02
|
|
|
276,075
|
|
|
$
|
92.30
|
|
ITEM 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
Novartis reported second quarter 2017 net sales of Promacta/Revolade (eltrombopag) of $210 million, a $52 million or 33% increase over the same period in 2016.
|
•
|
Novartis reported Revolade (eltrombopag) was approved in Canada for the treatment of pediatric (≥1 years to <18 years) chronic immune thrombocytopenia purpura to increase platelet counts in patients who have had an insufficient response to corticosteroids or immunoglobulins.
|
•
|
Novartis announced the publication of a study conducted by the National Institutes of Health demonstrating that 58% of patients with treatment-naïve severe aplastic anemia achieved complete response at six months when treated with eltrombopag at the initiation of and concurrent with standard immunosuppressive treatment. The data are published in the latest issue of
The New England Journal of Medicine
.
|
•
|
On July 25, 2017, Amgen reported second quarter 2017 net sales of Kyprolis (carfilzomib) of $211 million, a $39 million or 23% increase over the same period in 2016. On August 2, 2017, Ono Pharmaceutical Company reported Kyprolis sales in Japan of approximately $10.8 million for the most recent quarter.
|
•
|
On July 14, 2017, Amgen announced the submission of a supplemental New Drug Application to the FDA and a variation to the marketing application to the EMA to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for Kyprolis (carfilzomib).
|
•
|
On July 12, 2017, Amgen announced positive results from the final analysis of the Phase 3 ASPIRE trial, showing the study met the key secondary endpoint of overall survival, demonstrating that Kyprolis (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% over lenalidomide and dexamethasone alone.
|
•
|
On June 4, 2017, a Phase 1b study involving daratumumab in combination with KRd in patients with newly diagnosed multiple myeloma was highlighted in an Oral Abstract Session at the 2017 ASCO Annual Meeting.
|
•
|
Spectrum Pharmaceuticals reported second quarter 2017 net sales of EVOMELA of $10 million.
|
•
|
Melinta Therapeutics announced that the FDA approved both IV and oral Baxdela™ (delafloxacin) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. As a result of the approval, Ligand earned a $1.5 million milestone payment and will earn a 2.5% royalty on Baxdela IV sales. Following approval, Melinta Therapeutics entered into a $90 million loan and securities financing agreement with Oberland Capital Management, LLC to fund commercialization activities and indication expansion of Baxdela.
|
•
|
CorMatrix sold the rights to its commercial pericardial repair and CanGaroo
®
Envelope extracellular matrix (ECM) products to Aziyo Biologics. The transaction included a $10 million payment to Ligand to buy-down the royalty rate and also provided Ligand with an additional $10 million of sales-based milestones tied to the commercial success of the two products.
|
•
|
Retrophin announced that the United States Patent and Trademark Office and the European Patent Office each issued patents covering sparsentan for the treatment of focal segmental glomerulosclerosis.
|
•
|
Sage Therapeutics announced that
The Lancet
published results from a Phase 2, double-blind, randomized and placebo-controlled study of brexanolone in women with severe postpartum depression.
|
•
|
Aldeyra announced the last patient had completed dosing in their multicenter, double-blind, randomized Phase 2b clinical trial of ADX-102 in allergic conjunctivitis.
|
•
|
Aldeyra announced that it enrolled the first patient into a Phase 2a clinical trial of topical ocular ADX-102 for the treatment of Dry Eye Disease.
|
•
|
Novartis announced that it had exercised an option to in-license ECF843 (Lubricin) for ophthalmic indications from Lubris Biopharma. Ligand acquired economic rights to the Lubricin program from Selexis, SA in 2015.
|
•
|
Merrimack announced that it had enrolled the last patient in the ongoing CARRIE study, a Phase 2, double-blind, placebo-controlled, randomized trial evaluating MM-141 (istiratumab) in combination with standard of care in previously untreated patients with metastatic pancreatic cancer.
|
•
|
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 positive topline results from a preclinical study of VK2809 in an
in vivo
model of non-alcoholic steatohepatitis (NASH).
|
•
|
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.
|
•
|
Marinus Pharmaceuticals announced that it had initiated a Phase 2 double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and pharmacokinetics of ganaxolone IV in women diagnosed with severe postpartum depression.
|
•
|
Marinus Pharmaceuticals presented Phase 1 clinical data showing the safety and tolerability of ganaxolone IV at the 6
th
London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures.
|
•
|
Aptevo Therapeutics announced that aspects of its ADAPTIR™ protein therapeutic platform, including APVO436, an OmniAb-discovered antibody, were showcased at the Americas Antibody Congress 2017 and at the 2017 Next Generation Protein Therapeutics Summit.
|
•
|
XTL Biopharmaceuticals announced the receipt of additional preclinical data regarding the role of hCDR1 as a potential treatment for Sjögren's syndrome from Prof. Edna Mozes of The Weizmann Institute of Science and the developer of hCDR1.
|
•
|
Opthea Limited announced positive results from its Phase 1/2a clinical trial of OPT-302 for wet age-related macular degeneration (wet AMD). Opthea is planning to initiate a Phase 2b trial in wet AMD and a Phase 2a trial in diabetic macular edema in the second half of 2017.
|
•
|
Ligand announced worldwide license agreements with Surface Oncology and xCella Biosciences to use the OmniAb platform technologies to discover fully human antibodies. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.
|
•
|
Ligand announced a commercial license and supply agreement with Marinus Pharmaceuticals, granting rights to use Captisol in the formulation of IV ganaxolone. Ligand is eligible to receive milestone payments, royalties and revenue from Captisol material sales related to IV ganaxolone.
|
•
|
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 announced a commercial license and supply agreement with Interventional AnalgesiX granting rights to use Captisol in the formulation of an undisclosed compound. Ligand is eligible to receive milestone payments, tiered royalties of 5%-10% and revenue from Captisol material sales.
|
•
|
Ligand continues to expect to report topline data from the Phase 2 clinical trial with its novel, small-molecule GRA program (LGD-6972) for the treatment of type 2 diabetes mellitus in September 2017.
|
(Dollars in thousands)
|
Q2 2017
|
|
Q2 2016
|
|
Change
|
|
% Change
|
|
|
YTD 2017
|
|
YTD 2016
|
|
Change
|
|
% Change
|
||||||||||||||
Royalties
|
$
|
14,211
|
|
|
$
|
9,754
|
|
|
$
|
4,457
|
|
|
46
|
%
|
|
|
$
|
38,441
|
|
|
$
|
24,144
|
|
|
$
|
14,297
|
|
|
59
|
%
|
Material sales
|
5,550
|
|
|
3,886
|
|
|
1,664
|
|
|
43
|
%
|
|
|
6,672
|
|
|
9,227
|
|
|
(2,555
|
)
|
|
(28
|
)%
|
||||||
License fees, milestones and other revenue
|
8,234
|
|
|
5,881
|
|
|
2,353
|
|
|
40
|
%
|
|
|
12,151
|
|
|
15,798
|
|
|
(3,647
|
)
|
|
(23
|
)%
|
||||||
Total revenue
|
$
|
27,995
|
|
|
$
|
19,521
|
|
|
$
|
8,474
|
|
|
43
|
%
|
|
|
$
|
57,264
|
|
|
$
|
49,169
|
|
|
$
|
8,095
|
|
|
16
|
%
|
(Dollars in thousands)
|
Q2 2017
|
|
% of Revenue
|
|
Q2 2016
|
|
% of Revenue
|
|
YTD 2017
|
|
% of Revenue
|
|
YTD 2016
|
|
% of Revenue
|
||||||||
Costs of sales
|
$
|
903
|
|
|
|
|
$
|
720
|
|
|
|
|
$
|
1,244
|
|
|
|
|
$
|
1,675
|
|
|
|
Amortization of intangibles
|
2,706
|
|
|
|
|
2,681
|
|
|
|
|
5,420
|
|
|
|
|
5,206
|
|
|
|
||||
Research and development
|
4,822
|
|
|
|
|
4,914
|
|
|
|
|
13,495
|
|
|
|
|
8,915
|
|
|
|
||||
General and administrative
|
6,549
|
|
|
|
|
7,237
|
|
|
|
|
13,872
|
|
|
|
|
14,309
|
|
|
|
||||
Total operating costs and expenses
|
$
|
14,980
|
|
|
54%
|
|
$
|
15,552
|
|
|
80%
|
|
$
|
34,031
|
|
|
59%
|
|
$
|
30,105
|
|
|
61%
|
(Dollars in thousands)
|
Q2 2017
|
|
Q2 2016
|
|
Change
|
|
|
YTD 2017
|
|
YTD 2016
|
|
Change
|
||||||||||||
Interest expense, net
|
$
|
(2,860
|
)
|
|
$
|
(3,051
|
)
|
|
$
|
191
|
|
|
|
$
|
(5,803
|
)
|
|
$
|
(6,055
|
)
|
|
$
|
252
|
|
Increase in contingent liabilities
|
(825
|
)
|
|
(332
|
)
|
|
(493
|
)
|
|
|
(966
|
)
|
|
(1,638
|
)
|
|
672
|
|
||||||
Loss from Viking
|
(1,248
|
)
|
|
(11,138
|
)
|
|
9,890
|
|
|
|
(2,330
|
)
|
|
(12,743
|
)
|
|
10,413
|
|
||||||
Other income, net
|
218
|
|
|
501
|
|
|
(283
|
)
|
|
|
359
|
|
|
892
|
|
|
(533
|
)
|
||||||
Total other expense, net
|
$
|
(4,715
|
)
|
|
$
|
(14,020
|
)
|
|
$
|
9,305
|
|
|
|
$
|
(8,740
|
)
|
|
$
|
(19,544
|
)
|
|
$
|
10,804
|
|
(Dollars in thousands)
|
Q2 2017
|
|
Q2 2016
|
|
Change
|
|
|
YTD 2017
|
|
YTD 2016
|
|
Change
|
||||||||||||
Income before income taxes
|
$
|
8,300
|
|
|
$
|
(10,051
|
)
|
|
$
|
18,351
|
|
|
|
$
|
14,493
|
|
|
$
|
(480
|
)
|
|
$
|
14,973
|
|
Income tax expense
|
(2,242
|
)
|
|
3,881
|
|
|
(6,123
|
)
|
|
|
(3,356
|
)
|
|
187
|
|
|
(3,543
|
)
|
||||||
Income from operations
|
$
|
6,058
|
|
|
$
|
(6,170
|
)
|
|
$
|
12,228
|
|
|
|
11,137
|
|
|
(293
|
)
|
|
11,430
|
|
|||
Effective tax rate
|
27.0
|
%
|
|
38.6
|
%
|
|
|
|
|
|
23.2
|
%
|
|
39.0
|
%
|
|
|
|
(Dollars in thousands)
|
YTD 2017
|
|
YTD 2016
|
||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
34,608
|
|
|
$
|
23,485
|
|
Investing activities
|
8,535
|
|
|
(61,543
|
)
|
||
Financing activities
|
(1,672
|
)
|
|
1,980
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
41,471
|
|
|
$
|
(36,078
|
)
|
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
|
PART II.
|
OTHER INFORMATION
|
ITEM 1A.
|
RISK FACTORS
|
ITEM 6.
|
EXHIBITS
|
Date:
|
August 8, 2017
|
|
By:
|
/s/ Matthew Korenberg
|
|
|
|
|
Matthew Korenberg
|
|
|
|
|
Vice President, Finance and Chief Financial Officer
|
|
|
|
|
Duly Authorized Officer and Principal Financial Officer
|
Exhibit Number
|
Description
|
|
|
10.1
|
Royalty Agreement, dated May 31, 2017, by and between Ligand Pharmaceuticals Incorporated and Aziyo Med, LLC
|
10.2
|
Amended and Restated Interest Purchase Agreement, dated May 31, 2017, by and between Ligand Pharmaceuticals Incorporated and Cormatrix Cardiovascular, Inc.
|
31.1
|
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.
|
31.2
|
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.
|
32.1
|
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
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Ligand Pharmaceuticals Incorporated;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ John L. Higgins
|
John L. Higgins
|
Chief Executive Officer
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Ligand Pharmaceuticals Incorporated;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ Matthew Korenberg
|
Matthew Korenberg
|
Vice President, Finance and Chief Financial Officer
|
(Principal Financial Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|||
Date:
|
August 8, 2017
|
|
/s/ John L. Higgins
|
|
|
|
|
John L. Higgins
Chief Executive Officer
(Principal Executive Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|||
|
||||
Date:
|
August 8, 2017
|
|
|
/s/ Matthew Korenberg
|
|
|
|
Matthew Korenberg
Vice President, Finance and Chief Financial Officer
(Principal Financial Officer)
|