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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
|
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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ANDA
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Abbreviated New Drug Application
|
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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
|
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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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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GRA
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Glucagon receptor antagonist
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Hovione
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Hovione Farmaciencia
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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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Metabasis
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Metabasis Therapeutics, Inc.
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NOLs
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Net Operating Losses
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Novartis
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Novartis AG
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OMT
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OMT, Inc. or Open Monoclonal Technology, Inc.
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Orange Book
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Publication identifying drug products approved by the FDA based on safety and effectiveness
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Q1 2018
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The Company's fiscal quarter ended March 31, 2018
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Q1 2017
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The Company's fiscal quarter ended March 31, 2017
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Retrophin
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Retrophin Inc.
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Roivant
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Roivant Sciences GMBH
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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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|
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March 31, 2018
|
|
December 31, 2017
|
||||
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ASSETS
|
|
|
|
||||
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Current assets:
|
|
|
|
||||
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Cash and cash equivalents
|
$
|
51,024
|
|
|
$
|
20,620
|
|
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Short-term investments
|
213,329
|
|
|
181,041
|
|
||
|
Investment in Viking
|
27,535
|
|
|
—
|
|
||
|
Accounts receivable, net
|
37,108
|
|
|
25,596
|
|
||
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Note receivable from Viking
|
3,877
|
|
|
3,877
|
|
||
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Inventory
|
10,531
|
|
|
4,373
|
|
||
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Other current assets
|
5,647
|
|
|
1,514
|
|
||
|
Total current assets
|
349,051
|
|
|
237,021
|
|
||
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Deferred income taxes
|
69,368
|
|
|
84,422
|
|
||
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Investment in Viking
|
—
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6,438
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|
||
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Intangible assets, net
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225,306
|
|
|
228,584
|
|
||
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Goodwill
|
85,961
|
|
|
85,959
|
|
||
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Commercial license rights, net
|
19,969
|
|
|
19,526
|
|
||
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Property and equipment, net
|
4,119
|
|
|
4,212
|
|
||
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Other assets
|
894
|
|
|
4,859
|
|
||
|
Total assets
|
$
|
754,668
|
|
|
$
|
671,021
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
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|
|
||||
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Current liabilities:
|
|
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|
||||
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Accounts payable
|
$
|
3,407
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$
|
2,259
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Accrued liabilities
|
8,480
|
|
|
7,377
|
|
||
|
Current contingent liabilities
|
7,545
|
|
|
4,703
|
|
||
|
2019 convertible senior notes, net
|
227,547
|
|
|
224,529
|
|
||
|
Total current liabilities
|
246,979
|
|
|
238,868
|
|
||
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Long-term contingent liabilities
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6,376
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|
|
9,258
|
|
||
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Long-term deferred revenue, net
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3,000
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|
|
3,525
|
|
||
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Other long-term liabilities
|
1,135
|
|
|
723
|
|
||
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Total liabilities
|
257,490
|
|
|
252,374
|
|
||
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Commitments and contingencies
|
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|
||||
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Equity component of currently redeemable convertible notes (Note 3)
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16,078
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|
|
18,859
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|
||
|
Stockholders' equity:
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|
||||
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Common stock, $0.001 par value; 33,333,333 shares authorized; 21,301,980 and 21,148,665 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively
|
21
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|
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21
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|
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Additional paid-in capital
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808,765
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798,205
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|
||
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Accumulated other comprehensive (loss) income
|
(286
|
)
|
|
2,486
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|
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Accumulated deficit
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(327,400
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)
|
|
(400,924
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)
|
||
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Total stockholders' equity
|
481,100
|
|
|
399,788
|
|
||
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Total liabilities and stockholders' equity
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$
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754,668
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|
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$
|
671,021
|
|
|
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Three months ended
|
||||||
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March 31,
|
||||||
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|
2018
|
|
2017
|
||||
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Revenues:
|
|
|
|
||||
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Royalties
|
$
|
20,820
|
|
|
$
|
24,230
|
|
|
Material sales
|
4,391
|
|
|
1,121
|
|
||
|
License fees, milestones and other revenues
|
30,946
|
|
|
3,916
|
|
||
|
Total revenues
|
56,157
|
|
|
29,267
|
|
||
|
Operating costs and expenses:
|
|
|
|
||||
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Cost of sales
(1)
|
788
|
|
|
341
|
|
||
|
Amortization of intangibles
|
3,278
|
|
|
2,715
|
|
||
|
Research and development
|
7,407
|
|
|
8,673
|
|
||
|
General and administrative
|
7,643
|
|
|
7,322
|
|
||
|
Total operating costs and expenses
|
19,116
|
|
|
19,051
|
|
||
|
Income from operations
|
37,041
|
|
|
10,216
|
|
||
|
Other (expense) income:
|
|
|
|
||||
|
Interest expense, net
|
(2,605
|
)
|
|
(2,941
|
)
|
||
|
Increase in contingent liabilities
|
(960
|
)
|
|
(140
|
)
|
||
|
Gain (loss) from Viking
|
21,097
|
|
|
(1,083
|
)
|
||
|
Other income, net
|
739
|
|
|
141
|
|
||
|
Total other income (expense), net
|
18,271
|
|
|
(4,023
|
)
|
||
|
Income before income taxes
|
55,312
|
|
|
6,193
|
|
||
|
Income tax expense
|
(10,033
|
)
|
|
(1,114
|
)
|
||
|
Net income
|
$
|
45,279
|
|
|
$
|
5,079
|
|
|
|
|
|
|
||||
|
Basic net income per share
|
$
|
2.13
|
|
|
$
|
0.24
|
|
|
Shares used in basic per share calculations
|
21,209
|
|
|
20,938
|
|
||
|
|
|
|
|
|
|
||
|
Diluted net income per share
|
$
|
1.83
|
|
|
$
|
0.22
|
|
|
Shares used in diluted per share calculations
|
24,800
|
|
|
23,019
|
|
||
|
|
|
|
|
||||
|
|
|
|
|
||||
|
|
Three months ended
|
||||||
|
|
March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
Net income:
|
$
|
45,279
|
|
|
$
|
5,079
|
|
|
Unrealized net gain on available-for-sale securities, net of tax
|
(149
|
)
|
|
(66
|
)
|
||
|
Less: Reclassification of net realized gain included in net income, net of tax
|
—
|
|
|
428
|
|
||
|
Comprehensive income
|
$
|
45,130
|
|
|
$
|
5,441
|
|
|
|
Three months ended
|
||||||
|
|
March 31,
|
||||||
|
|
2018
|
|
2017 (Revised)
|
||||
|
Operating activities
|
|
|
|
||||
|
Net income
|
$
|
45,279
|
|
|
$
|
5,079
|
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
|
Non-cash change in estimated fair value of contingent liabilities
|
960
|
|
|
140
|
|
||
|
Depreciation and amortization
|
3,002
|
|
|
2,979
|
|
||
|
Amortization of debt discount and issuance fees
|
3,018
|
|
|
2,838
|
|
||
|
Stock-based compensation
|
4,555
|
|
|
6,045
|
|
||
|
Deferred income taxes
|
9,862
|
|
|
1,018
|
|
||
|
Change in fair value of the Viking convertible debt receivable and warrants
|
(748
|
)
|
|
(76
|
)
|
||
|
(Gain) / loss from equity investments
|
(21,183
|
)
|
|
1,083
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Payments to CVR holders and other contingency payments
|
—
|
|
|
(4,998
|
)
|
||
|
Royalties recorded in retained earnings upon adoption of ASU 606
|
32,707
|
|
|
—
|
|
||
|
Accounts receivable
|
(11,512
|
)
|
|
7,643
|
|
||
|
Inventory
|
(4,978
|
)
|
|
(1,197
|
)
|
||
|
Accounts payable and accrued liabilities
|
321
|
|
|
(1,963
|
)
|
||
|
Other
|
(522
|
)
|
|
633
|
|
||
|
Net cash provided by operating activities
|
60,761
|
|
|
19,224
|
|
||
|
Investing activities
|
|
|
|
||||
|
Payments to CVR holders and other contingency payments
|
(1,000
|
)
|
|
—
|
|
||
|
Purchase of short-term investments
|
(98,957
|
)
|
|
(73,352
|
)
|
||
|
Proceeds from sale of short-term investments
|
12,291
|
|
|
17,719
|
|
||
|
Proceeds from maturity of short-term investments
|
54,325
|
|
|
30,052
|
|
||
|
Other
|
(240
|
)
|
|
(87
|
)
|
||
|
Net cash used in investing activities
|
(33,581
|
)
|
|
(25,668
|
)
|
||
|
Financing activities
|
|
|
|
||||
|
Net proceeds from stock option exercises and ESPP
|
8,916
|
|
|
355
|
|
||
|
Taxes paid related to net share settlement of equity awards
|
(3,797
|
)
|
|
(2,022
|
)
|
||
|
Share repurchase
|
(1,895
|
)
|
|
—
|
|
||
|
Net cash provided by (used in) provided by financing activities
|
3,224
|
|
|
(1,667
|
)
|
||
|
Net increase (decrease) in cash and cash equivalents
|
30,404
|
|
|
(8,111
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
20,620
|
|
|
18,752
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
51,024
|
|
|
$
|
10,641
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
||||
|
Interest paid
|
$
|
919
|
|
|
$
|
919
|
|
|
Taxes paid
|
$
|
171
|
|
|
$
|
96
|
|
|
Supplemental schedule of non-cash activity
|
|
|
|
||||
|
Accrued inventory purchases
|
$
|
1,180
|
|
|
$
|
3,909
|
|
|
Unrealized gain (loss) on AFS investments
|
$
|
—
|
|
|
$
|
(66
|
)
|
|
|
|
Three months ended
|
||||||
|
|
|
March 31,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
Material Sales
|
|
|
|
|||||
|
|
Captisol
|
$
|
4,391
|
|
|
$
|
1,121
|
|
|
License fees, milestones and other
|
|
|
|
|||||
|
|
License Fees
|
$
|
26,955
|
|
|
$
|
2,872
|
|
|
|
Milestone
|
2,825
|
|
|
1,008
|
|
||
|
|
Other
|
1,166
|
|
|
36
|
|
||
|
|
|
$
|
30,946
|
|
|
$
|
3,916
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||||||||||||||||||||||||
|
|
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
|
$
|
94,855
|
|
|
$
|
5
|
|
|
$
|
(97
|
)
|
|
$
|
94,763
|
|
|
$
|
80,095
|
|
|
$
|
6
|
|
|
$
|
(42
|
)
|
|
$
|
80,059
|
|
|
Corporate bonds
|
73,129
|
|
|
—
|
|
|
(216
|
)
|
|
72,913
|
|
|
55,335
|
|
|
—
|
|
|
(96
|
)
|
|
55,239
|
|
||||||||
|
Commercial paper
|
29,977
|
|
|
—
|
|
|
(26
|
)
|
|
29,951
|
|
|
27,933
|
|
|
—
|
|
|
(20
|
)
|
|
27,913
|
|
||||||||
|
U.S. Government bonds
|
11,964
|
|
|
—
|
|
|
(22
|
)
|
|
11,942
|
|
|
8,939
|
|
|
—
|
|
|
(10
|
)
|
|
8,929
|
|
||||||||
|
Agency bonds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,991
|
|
|
—
|
|
|
(1
|
)
|
|
4,990
|
|
||||||||
|
Municipal bonds
|
2,014
|
|
|
—
|
|
|
(12
|
)
|
|
2,002
|
|
|
2,028
|
|
|
—
|
|
|
(13
|
)
|
|
2,015
|
|
||||||||
|
Corporate equity securities
|
181
|
|
|
1,577
|
|
|
—
|
|
|
1,758
|
|
|
207
|
|
|
1,689
|
|
|
—
|
|
|
1,896
|
|
||||||||
|
|
$
|
212,120
|
|
|
$
|
1,582
|
|
|
$
|
(373
|
)
|
|
$
|
213,329
|
|
|
$
|
179,528
|
|
|
$
|
1,695
|
|
|
$
|
(182
|
)
|
|
$
|
181,041
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
2018
|
|
2017
|
||||
|
Indefinite lived intangible assets
|
|
|
|
||||
|
IPR&D
|
$
|
2,410
|
|
|
$
|
7,923
|
|
|
Goodwill
|
85,961
|
|
|
85,959
|
|
||
|
Definite lived intangible assets
|
|
|
|
||||
|
Complete technology
|
228,413
|
|
|
222,900
|
|
||
|
Less: Accumulated amortization
|
(26,176
|
)
|
|
(23,301
|
)
|
||
|
Trade name
|
2,642
|
|
|
2,642
|
|
||
|
Less: Accumulated amortization
|
(949
|
)
|
|
(916
|
)
|
||
|
Customer relationships
|
29,600
|
|
|
29,600
|
|
||
|
Less: Accumulated amortization
|
(10,634
|
)
|
|
(10,264
|
)
|
||
|
Total goodwill and other identifiable intangible assets, net
|
$
|
311,267
|
|
|
$
|
314,543
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
2018
|
|
2017
|
||||
|
Aziyo and CorMatrix
|
$
|
17,696
|
|
|
$
|
17,696
|
|
|
Selexis
|
8,602
|
|
|
8,602
|
|
||
|
|
$
|
26,298
|
|
|
$
|
26,298
|
|
|
Less: accumulated amortization
|
(6,329
|
)
|
|
(6,772
|
)
|
||
|
Total commercial rights, net
|
$
|
19,969
|
|
|
$
|
19,526
|
|
|
|
|
Three months ended
|
||||||
|
|
|
March 31,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
Condensed Statement of Operations:
|
|
|
|
|
||||
|
Total revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Gross profit
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Loss from operations
|
|
$
|
4,805
|
|
|
$
|
4,968
|
|
|
Net Loss
|
|
$
|
3,551
|
|
|
$
|
5,222
|
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
|
2018
|
|
2017
|
||||
|
Condensed Balance Sheet:
|
|
|
|
|
||||
|
Current assets
|
|
$
|
78,731
|
|
|
$
|
21,852
|
|
|
Noncurrent assets
|
|
240
|
|
|
270
|
|
||
|
|
|
$
|
78,971
|
|
|
$
|
22,122
|
|
|
|
|
|
|
|
||||
|
Current liabilities
|
|
$
|
6,339
|
|
|
$
|
8,657
|
|
|
Noncurrent liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Stockholder's equity
|
|
$
|
72,632
|
|
|
$
|
13,465
|
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
|
2018
|
|
2017
|
||||
|
Compensation
|
|
$
|
1,455
|
|
|
$
|
4,085
|
|
|
Professional fees
|
|
497
|
|
|
430
|
|
||
|
Amounts owed to former licensees
|
|
3,417
|
|
|
396
|
|
||
|
Royalties owed to third parties
|
|
1,043
|
|
|
954
|
|
||
|
Deferred revenue
|
|
75
|
|
|
173
|
|
||
|
Other
|
|
1,993
|
|
|
1,339
|
|
||
|
Total accrued liabilities
|
|
$
|
8,480
|
|
|
$
|
7,377
|
|
|
|
Three months ended
|
||||||
|
|
March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
Stock-based compensation expense as a component of:
|
|
|
|
||||
|
Research and development expenses
|
$
|
1,767
|
|
|
$
|
3,939
|
|
|
General and administrative expenses
|
2,788
|
|
|
2,106
|
|
||
|
|
$
|
4,555
|
|
|
$
|
6,045
|
|
|
|
Three months ended
|
||
|
|
March 31,
|
||
|
|
2018
|
|
2017
|
|
Risk-free interest rate
|
2.7%
|
|
2.1%
|
|
Dividend yield
|
—
|
|
—
|
|
Expected volatility
|
33%
|
|
47%
|
|
Expected term
|
5.7
|
|
6.9
|
|
|
Three months ended
|
||||
|
|
March 31,
|
||||
|
|
2018
|
|
2017
|
||
|
Weighted average shares outstanding:
|
21,208,793
|
|
|
20,937,627
|
|
|
Dilutive potential common shares:
|
|
|
|
||
|
Restricted stock
|
63,959
|
|
|
185,745
|
|
|
Stock options
|
1,119,611
|
|
|
954,509
|
|
|
2019 Convertible Senior Notes
|
1,719,099
|
|
|
941,308
|
|
|
Warrants
|
688,852
|
|
|
—
|
|
|
Shares used to compute diluted income per share
|
24,800,314
|
|
|
23,019,189
|
|
|
Potentially dilutive shares excluded from calculation due to anti-dilutive effect
|
148,404
|
|
|
3,711,067
|
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||||||||||||||||||||||||
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Short-term investments
(1)
|
|
$
|
29,292
|
|
|
$
|
211,572
|
|
|
$
|
—
|
|
|
$
|
240,864
|
|
|
$
|
1,896
|
|
|
$
|
179,145
|
|
|
$
|
—
|
|
|
$
|
181,041
|
|
|
Note receivable Viking
(2)
|
|
—
|
|
|
—
|
|
|
3,877
|
|
|
3,877
|
|
|
—
|
|
|
—
|
|
|
3,877
|
|
|
3,877
|
|
||||||||
|
Investment in warrants
(3)
|
|
4,594
|
|
|
—
|
|
|
—
|
|
|
4,594
|
|
|
3,846
|
|
|
—
|
|
|
—
|
|
|
3,846
|
|
||||||||
|
Total assets
|
|
$
|
33,886
|
|
|
$
|
211,572
|
|
|
$
|
3,877
|
|
|
$
|
249,335
|
|
|
$
|
5,742
|
|
|
$
|
179,145
|
|
|
$
|
3,877
|
|
|
$
|
188,764
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Current portion of contingent liabilities - Crystal
(7)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,618
|
|
|
$
|
3,618
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,618
|
|
|
4,618
|
|
|
|
Current contingent liabilities-CyDex
(4)
|
|
—
|
|
|
—
|
|
|
86
|
|
|
86
|
|
|
—
|
|
|
—
|
|
|
86
|
|
|
86
|
|
||||||||
|
Long-term portion of contingent liabilities - Crystal
(7)
|
|
—
|
|
|
—
|
|
|
3,783
|
|
|
3,783
|
|
|
—
|
|
|
—
|
|
|
3,783
|
|
|
3,783
|
|
||||||||
|
Long-term contingent liabilities-CyDex
(4)
|
|
—
|
|
|
—
|
|
|
1,503
|
|
|
1,503
|
|
|
—
|
|
|
—
|
|
|
1,503
|
|
|
1,503
|
|
||||||||
|
Long-term contingent liabilities-Metabasis
(5)
|
|
—
|
|
|
1,089
|
|
|
—
|
|
|
1,089
|
|
|
—
|
|
|
3,971
|
|
|
—
|
|
|
3,971
|
|
||||||||
|
Liability for amounts owed to former licensees
(6)
|
|
264
|
|
|
—
|
|
|
—
|
|
|
264
|
|
|
284
|
|
|
—
|
|
|
—
|
|
|
284
|
|
||||||||
|
Total liabilities
|
|
$
|
264
|
|
|
$
|
1,089
|
|
|
$
|
8,990
|
|
|
$
|
10,343
|
|
|
$
|
284
|
|
|
$
|
3,971
|
|
|
$
|
9,990
|
|
|
$
|
14,245
|
|
|
(1)
|
Investments in equity securities, which the Company received from Viking and another licensee as upfront and event-based payments, 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 debt 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 approximates the book value since it will mature in May 21, 2018.
|
|
(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. At
March 31, 2018
, the Company has a CVR payable of
$3.8 million
to the Glucagon CVR holders due on July 2, 2018, which is not included in the fair value disclosure.
|
|
(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.
|
|
(7)
|
The fair value of Crystal contingent liabilities was determined using a probability weighted income approach. Most of the contingent payments are based on development or regulatory milestones as defined in the merger agreement with Crystal. The fair value is subjective and is affected by changes in inputs to the valuation model including management’s estimates regarding the timing and probability of achievement of certain developmental and regulatory milestones. At
March 31, 2018
, most of the development and regulatory milestones were estimated to be highly probable of being achieved between 2018 and 2019. Changes in these estimates may materially affect the fair value.
|
|
|
March 31, 2018
|
|
December 31, 2017
|
|
Revenue volatility
|
25%
|
|
25%
|
|
Average probability of commercialization
|
12.5%
|
|
12.5%
|
|
Market price of risk
|
2.9%
|
|
2.9%
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
|
Principal amount outstanding
|
$
|
245,000
|
|
|
$
|
245,000
|
|
|
Unamortized discount (including unamortized debt issuance cost)
|
(17,453
|
)
|
|
(20,471
|
)
|
||
|
Total current portion of notes payable
|
$
|
227,547
|
|
|
$
|
224,529
|
|
|
|
Stock Options
|
|
Restricted Stock Awards
|
||||||||||
|
|
Shares
|
|
Weighted-
Average
Exercise
Price
|
|
Shares
|
|
Weighted-
Average Grant
Date Fair Value
|
||||||
|
Balance as of December 31, 2017
|
1,876,332
|
|
|
$
|
53.17
|
|
|
133,294
|
|
|
$
|
91.60
|
|
|
Granted
|
202,994
|
|
|
159.02
|
|
|
45,203
|
|
|
158.29
|
|
||
|
Options exercised/RSUs vested
|
(133,800
|
)
|
|
64.73
|
|
|
(53,501
|
)
|
|
80.49
|
|
||
|
Balance as of March 31, 2018
|
1,945,526
|
|
|
$
|
63.43
|
|
|
124,996
|
|
|
$
|
120.48
|
|
|
ITEM 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
•
|
Novartis reported first quarter 2018 net sales of Promacta/Revolade (eltrombopag) of $257 million, an $82 million or 47% increase over the same period in 2017.
|
|
•
|
Novartis announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Promacta for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia as a first-line therapy.
|
|
•
|
On April 24, 2018, Amgen reported first quarter net sales of Kyprolis of $222 million, a $32 million or 17% increase over the same period in 2017. On May 9, 2018, Ono Pharmaceutical Company is expected to report Kyprolis sales in Japan for the most recent quarter.
|
|
•
|
On January 17, 2018, Amgen announced that the FDA approved the supplemental New Drug Application to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for Kyprolis.
|
|
•
|
On January 30, 2018, Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) adopted a positive opinion recommending a label variation for Kyprolis to include updated OS data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma.
|
|
•
|
On April 30, 2018, Amgen announced that the CHMP adopted a positive opinion recommending a label variation for Kyprolis to include the final overall survival (OS) data from the Phase 3 ASPIRE trial.
|
|
•
|
Ligand announced the signing of a license agreement granting Roivant Sciences exclusive global rights to develop and commercialize LGD-6972 (now named RVT-1502), Ligand’s glucagon receptor antagonist (GRA). Under the terms of the agreement, Ligand received a $20 million upfront license fee, and is eligible to receive up to an additional $528.8 million of milestone payments and tiered royalties ranging from low double digits to the mid-teens, with the top tier applying to annual net sales above $3 billion. Roivant is responsible for all costs related to the program.
|
|
•
|
Ligand announced worldwide license agreements with venBio Partners, Ferring Pharmaceuticals and Glenmark Pharmaceuticals to use the OmniAb platform technologies to discover fully human antibodies. The agreement with venBio permits the venture capital firm’s portfolio companies to enter into worldwide OmniAb platform agreements under previously agreed-upon terms. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.
|
|
•
|
Sage Therapeutics announced the submission of a New Drug Application to the FDA for an intravenous (IV) formulation of brexanolone for the treatment of postpartum depression.
|
|
•
|
Retrophin announced first patient enrollment in the Phase 3 DUPLEX Study evaluating the long-term nephroprotective potential of sparsentan for the treatment of focal segmental glomerulosclerosis. Topline data from the 36-week interim efficacy endpoint analysis are expected in the second half of 2020.
|
|
•
|
Retrophin announced that the company received regulatory feedback from both the FDA and European Medicines Agency (EMA) on the development pathway for sparsentan in IgA nephropathy and that a single registration-enabling Phase 3 clinical trial is expected to be initiated in the fourth quarter of 2018
|
|
•
|
Melinta Therapeutics announced the U.S. launch of the Captisol-enabled IV formulation of Baxdela for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.
|
|
•
|
Melinta Therapeutics announced that The Menarini Group and Eurofarma Laboratórios submitted regulatory applications for delafloxacin (Baxdela in the U.S.) in the European Union and Argentina, respectively.
|
|
•
|
CASI Pharmaceuticals announced a $50 million private placement to prepare for commercialization in China, including potentially for EVOMELA, which has a regulatory application outstanding under priority review with an Expert Advisory Committee review date of April 25-26, 2018.
|
|
•
|
Aldeyra Therapeutics announced enrollment of the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis and also enrollment of the first patient in a Phase 2b clinical trial of reproxalap for the treatment of dry eye disease.
|
|
•
|
Aldeyra Therapeutics presented the results of a Phase 2a dry eye disease clinical trial of topical ocular reproxalap at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting.
|
|
•
|
Exelixis announced that its partner Daiichi Sankyo had submitted a regulatory application for esaxerenone (CS-3150) in patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency.
|
|
•
|
Takeda Pharmaceuticals highlighted the Phase 3 initiation of pevonedistat and its TAK-020 program during its presentation at the JP Morgan 36
th
Annual Healthcare Conference.
|
|
•
|
Merrimack Pharmaceuticals announced it had dosed the first patient in its Phase 2 SHERBOC study of MM-121 (seribantumab) in patients with heregulin-positive, hormone receptor-positive and HER2-negative post-menopausal metastatic breast cancer.
|
|
•
|
Viking Therapeutics announced the pricing of a $63.3 million public offering of common stock (including over-allotment exercise) with proceeds to fund continued development of VK5211, VK2809 and VK0214.
|
|
•
|
Opthea announced commencing a Phase 1b/2a trial evaluating the safety and efficacy of OPT-302 in patients with center-involved diabetic macular edema.
|
|
•
|
Syros Pharmaceuticals announced new preclinical data showing that Captisol-enabled SY-1365, a first-in-class selective cyclin-dependent kinase 7 inhibitor currently in a Phase 1 trial in patients with advanced solid tumors, demonstrated potent anti-tumor activity in multiple models of heavily pretreated ovarian cancer.
|
|
•
|
Aptevo Therapeutics announced that it had submitted an Investigational New Drug application to the FDA to evaluate APVO436 in a Phase 1 clinical study for the treatment of patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
|
|
•
|
Aptevo Therapeutics presented new data for APVO436 at the American Association for Cancer Research (AACR) 2018 Annual Meeting.
|
|
•
|
OmniAb partner Ferring Pharmaceuticals announced it is expanding its capabilities in biologics by constructing a new CHF30 million biotech center and manufacturing site.
|
|
•
|
Arcus Biosciences presented a poster on OmniAb-derived GLS-010 (AB122) at the AACR 2018 Annual Meeting.
|
|
•
|
Nucorion Pharmaceuticals presented preclinical data for its novel liver-targeting prodrug technology program, NCO-1010, for the potential treatment of hepatitis B at the European Association for the Study of the Liver’s International Liver Congress.
|
|
•
|
Ligand announced initiation of an internally funded program to develop through proof-of-concept contrast agents with reduced renal toxicity for diagnostic imaging procedures. This development program will leverage Ligand’s Captisol technology, as well as intellectual property obtained through its acquisition of Verrow Pharmaceuticals for $2 million in cash plus earn outs.
|
|
•
|
Ligand presented a poster at the National Lipid Association's 2018 Scientific Sessions showing that Ligand’s LTP Technology significantly improves liver targeting of the statin rosuvastatin (Crestor
®
), and may potentially be an effective strategy to increase the therapeutic index of statins and reduce statin intolerance.
|
|
•
|
A paper by Ligand scientists entitled “Chickens with humanized immunoglobulin genes generate antibodies with high affinity and broad epitope coverage to conserved targets” was published in the journal
MAbs
, highlighting the use of OmniChicken in antibody drug discovery.
|
|
(Dollars in thousands)
|
Q1 2018
|
|
Q1 2017
|
|
Change
|
|
% Change
|
|
|
|||||||
|
Royalties
|
$
|
20,820
|
|
|
$
|
24,230
|
|
|
$
|
(3,410
|
)
|
|
(14
|
)%
|
|
|
|
Material sales
|
4,391
|
|
|
1,121
|
|
|
3,270
|
|
|
292
|
%
|
|
|
|||
|
License fees, milestones and other revenue
|
30,946
|
|
|
3,916
|
|
|
27,030
|
|
|
690
|
%
|
|
|
|||
|
Total revenue
|
$
|
56,157
|
|
|
$
|
29,267
|
|
|
$
|
26,890
|
|
|
92
|
%
|
|
|
|
(in millions)
|
Q1 2018 Estimated Partner Product Sales
|
Effective Royalty Rate
|
Q1 2018 Royalty Revenue under ASC 606
|
|
Q4 2017 Partner Product Sales
|
Effective Royalty Rate
|
Q1 2018 Royalty Revenue under ASC 605
(1)
|
|
Q4 2016 Partner Products Sales
|
Effective Royalty Rate
|
Q1 2017 Royalty Revenue under ASC 605
|
|||||||||||||||
|
Promacta
|
$
|
257.0
|
|
6.07
|
%
|
$
|
15.6
|
|
|
$
|
255.3
|
|
9.44
|
%
|
$
|
24.1
|
|
|
$
|
177.0
|
|
9.44
|
%
|
$
|
16.7
|
|
|
Kyprolis
|
234.0
|
|
1.41
|
%
|
3.3
|
|
|
227.0
|
|
2.86
|
%
|
6.5
|
|
|
187.4
|
|
2.45
|
%
|
4.6
|
|
||||||
|
Evomela
|
8.0
|
|
20.00
|
%
|
1.6
|
|
|
8.0
|
|
20.00
|
%
|
1.6
|
|
|
9.4
|
|
20.00
|
%
|
1.9
|
|
||||||
|
Other
|
42.0
|
|
0.71
|
%
|
0.3
|
|
|
41.0
|
|
1.22
|
%
|
0.5
|
|
|
45.0
|
|
2.22
|
%
|
1.0
|
|
||||||
|
Total
|
$
|
541.0
|
|
|
$
|
20.8
|
|
|
$
|
373.8
|
|
|
$
|
32.7
|
|
|
$
|
418.8
|
|
|
$
|
24.2
|
|
|||
|
(Dollars in thousands)
|
Q1 2018
|
|
% of Revenue
|
|
Q1 2017
|
|
% of Revenue
|
||||
|
Costs of sales
|
$
|
788
|
|
|
|
|
$
|
341
|
|
|
|
|
Amortization of intangibles
|
3,278
|
|
|
|
|
2,715
|
|
|
|
||
|
Research and development
|
7,407
|
|
|
|
|
8,673
|
|
|
|
||
|
General and administrative
|
7,643
|
|
|
|
|
7,322
|
|
|
|
||
|
Total operating costs and expenses
|
$
|
19,116
|
|
|
34%
|
|
$
|
19,051
|
|
|
65%
|
|
(Dollars in thousands)
|
Q1 2018
|
|
Q1 2017
|
|
Change
|
||||||
|
Interest expense, net
|
$
|
(2,605
|
)
|
|
$
|
(2,941
|
)
|
|
$
|
336
|
|
|
Increase in contingent liabilities
|
(960
|
)
|
|
(140
|
)
|
|
(820
|
)
|
|||
|
Gain (loss) from Viking
|
21,097
|
|
|
(1,083
|
)
|
|
22,180
|
|
|||
|
Other income, net
|
739
|
|
|
141
|
|
|
598
|
|
|||
|
Total other expense, net
|
$
|
18,271
|
|
|
$
|
(4,023
|
)
|
|
$
|
22,294
|
|
|
(Dollars in thousands)
|
Q1 2018
|
|
Q1 2017
|
|
Change
|
||||||
|
Income before income taxes
|
$
|
55,312
|
|
|
$
|
6,193
|
|
|
$
|
49,119
|
|
|
Income tax expense
|
(10,033
|
)
|
|
(1,114
|
)
|
|
(8,919
|
)
|
|||
|
Income from operations
|
$
|
45,279
|
|
|
$
|
5,079
|
|
|
$
|
40,200
|
|
|
Effective tax rate
|
18.1
|
%
|
|
18.0
|
%
|
|
|
|
|||
|
(Dollars in thousands)
|
Q1 2018
|
|
Q1 2017 Revised
|
||||
|
Net cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
60,761
|
|
|
$
|
19,224
|
|
|
Investing activities
|
(33,581
|
)
|
|
(25,668
|
)
|
||
|
Financing activities
|
3,224
|
|
|
(1,667
|
)
|
||
|
Net increase (decrease) in cash and cash equivalents
|
$
|
30,404
|
|
|
$
|
(8,111
|
)
|
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
|
|
OTHER INFORMATION
|
|
ITEM 1A.
|
RISK FACTORS
|
|
ITEM 6.
|
EXHIBITS
|
|
Date:
|
May 9, 2018
|
|
By:
|
/s/ Matthew Korenberg
|
|
|
|
|
|
Matthew Korenberg
|
|
|
|
|
|
Executive 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.
|
|
|
Amendment No. 5 to Sublicense Agreement, dated March 20, 2018, among the Company, Pharmacopeia, LLC and Retrophin, Inc.
|
|
|
License Agreement, dated March 5, 2018, by and between the Company and Roivant Sciences GmbH†
|
|
|
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 |
|---|