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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
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o
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(Do not check if a smaller reporting company)
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Smaller Reporting Company
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o
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Emerging growth company
|
o
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PART I. FINANCIAL INFORMATION
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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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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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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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Par
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Par Pharmaceuticals, Inc.
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Retrophin
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Retrophin Inc.
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Q1 2017
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The Company's fiscal quarter ended March 31, 2017
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Q1 2016
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The Company's fiscal quarter ended March 31, 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
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ITEM 1.
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FINANCIAL STATEMENTS
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March 31, 2017
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December 31, 2016
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||||
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ASSETS
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|
||||
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Current assets:
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||||
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Cash and cash equivalents
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$
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10,641
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$
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18,752
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Short-term investments
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148,733
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122,296
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Accounts receivable
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7,057
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14,700
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|
||
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Note receivable from Viking
|
—
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3,207
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|
||
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Inventory
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7,629
|
|
|
1,923
|
|
||
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Other current assets
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641
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|
|
2,175
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|
||
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Total current assets
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174,701
|
|
|
163,053
|
|
||
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Deferred income taxes
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141,007
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|
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123,891
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Investment in Viking
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7,262
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8,345
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|
||
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Note receivable from Viking
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3,207
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|
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—
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Intangible assets, net
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201,990
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204,705
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Goodwill
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72,207
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72,207
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Commercial license rights, net
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25,630
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25,821
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Property and equipment, net
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1,898
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1,819
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Other assets
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1,821
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1,744
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Total assets
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$
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629,723
|
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$
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601,585
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|
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
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|
||||
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Current liabilities:
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|
||||
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Accounts payable
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$
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6,456
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$
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2,734
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Accrued liabilities
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4,680
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6,397
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|
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Current contingent liabilities
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111
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5,088
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|
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2019 Convertible Senior Notes, net
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215,748
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212,910
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Total current liabilities
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226,995
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227,129
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Long-term contingent liabilities
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3,035
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|
2,916
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|
||
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Other long-term liabilities
|
915
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|
|
687
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|
||
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Total liabilities
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230,945
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|
|
230,732
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|
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Commitments and Contingencies
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||||
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Equity component of currently redeemable convertible notes (Note 5)
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26,948
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29,563
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Stockholders' equity:
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|
||||
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Common stock, $0.001 par value; 33,333,333 shares authorized; 20,996,049 and 20,909,301 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively
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21
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21
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Additional paid-in capital
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777,102
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769,653
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Accumulated other comprehensive income
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3,105
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2,743
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|
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Accumulated deficit
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(408,398
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)
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(431,127
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)
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Total stockholders' equity
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371,830
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341,290
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|
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Total liabilities and stockholders' equity
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$
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629,723
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$
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601,585
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Three months ended
|
||||||
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March 31,
|
||||||
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2017
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2016
|
||||
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Revenues:
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|
||||
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Royalties
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$
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24,230
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$
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14,390
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Material sales
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1,121
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|
|
5,341
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|
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License fees, milestones and other revenues
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3,916
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|
|
9,917
|
|
||
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Total revenues
|
29,267
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|
|
29,648
|
|
||
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Operating costs and expenses:
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|
|
||||
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Cost of sales
(1)
|
341
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|
|
955
|
|
||
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Amortization of intangibles
|
2,715
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|
|
2,524
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|
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Research and development
|
8,673
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4,004
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|
||
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General and administrative
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7,322
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|
|
7,069
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|
||
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Total operating costs and expenses
|
19,051
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|
|
14,552
|
|
||
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Income from operations
|
10,216
|
|
|
15,096
|
|
||
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Other (expense) income:
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|
||||
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Interest expense, net
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(2,941
|
)
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(3,005
|
)
|
||
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Increase in contingent liabilities
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(140
|
)
|
|
(1,306
|
)
|
||
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Loss from Viking
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(1,083
|
)
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(1,605
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)
|
||
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Other income, net
|
141
|
|
|
391
|
|
||
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Total other expense, net
|
(4,023
|
)
|
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(5,525
|
)
|
||
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Income before income taxes
|
6,193
|
|
|
9,571
|
|
||
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Income tax expense
|
(1,114
|
)
|
|
(3,694
|
)
|
||
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Income from operations
|
5,079
|
|
|
5,877
|
|
||
|
Discontinued operations:
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|
|
|
||||
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Gain on sale of Oncology Product Line before income taxes
|
—
|
|
|
1,139
|
|
||
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Income tax expense on discontinued operations
|
—
|
|
|
(408
|
)
|
||
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Income from discontinued operations
|
—
|
|
|
731
|
|
||
|
Net income
|
$
|
5,079
|
|
|
$
|
6,608
|
|
|
Per share amounts attributable to Ligand common shareholders:
|
|
|
|
||||
|
Basic earnings per share data
(2)
|
|
|
|
||||
|
Income from continuing operations
|
$
|
0.24
|
|
|
$
|
0.28
|
|
|
Income from discontinued operations
|
—
|
|
|
0.04
|
|
||
|
Net income
|
$
|
0.24
|
|
|
$
|
0.32
|
|
|
|
|
|
|
||||
|
Diluted earnings per share data
(2)
|
|
|
|
|
|
||
|
Income from continuing operations
|
$
|
0.22
|
|
|
$
|
0.26
|
|
|
Income from discontinued operations
|
—
|
|
|
0.03
|
|
||
|
Net income
|
$
|
0.22
|
|
|
$
|
0.30
|
|
|
|
|
|
|
||||
|
Shares used for computation (in thousands)
|
|
|
|
||||
|
Basic
|
20,938
|
|
|
20,708
|
|
||
|
Diluted
|
23,019
|
|
|
22,284
|
|
||
|
|
Three months ended
|
||||||
|
|
March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Net income:
|
$
|
5,079
|
|
|
$
|
6,608
|
|
|
Unrealized net gain on available-for-sale securities, net of tax
|
(66
|
)
|
|
(1,098
|
)
|
||
|
Less: Reclassification of net realized (gain)/loss included in net income, net of tax of $202
|
428
|
|
|
(236
|
)
|
||
|
Comprehensive income
|
$
|
5,441
|
|
|
$
|
5,274
|
|
|
|
Three months ended
|
||||||
|
|
March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Operating activities
|
|
|
|
||||
|
Net income
|
$
|
5,079
|
|
|
$
|
6,608
|
|
|
Less: income from discontinued operations
|
—
|
|
|
731
|
|
||
|
Income from continuing operations
|
5,079
|
|
|
5,877
|
|
||
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
|
Non-cash change in estimated fair value of contingent liabilities
|
140
|
|
|
1,306
|
|
||
|
Realized gain on sale of short-term investment
|
(66
|
)
|
|
(406
|
)
|
||
|
Depreciation and amortization
|
2,979
|
|
|
2,575
|
|
||
|
Amortization of premium (discount) on investments, net
|
(46
|
)
|
|
320
|
|
||
|
Amortization of debt discount and issuance fees
|
2,838
|
|
|
2,668
|
|
||
|
Stock-based compensation
|
6,045
|
|
|
4,118
|
|
||
|
Deferred income taxes
|
1,018
|
|
|
4,101
|
|
||
|
Change in fair value of the Viking convertible debt receivable and warrants
|
(76
|
)
|
|
15
|
|
||
|
Loss from Viking
|
1,083
|
|
|
1,605
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable
|
7,643
|
|
|
(5,604
|
)
|
||
|
Inventory
|
(1,197
|
)
|
|
853
|
|
||
|
Other current assets
|
745
|
|
|
16
|
|
||
|
Accounts payable and accrued liabilities
|
(1,963
|
)
|
|
(4,302
|
)
|
||
|
Other
|
—
|
|
|
(28
|
)
|
||
|
Net cash provided by operating activities
|
24,222
|
|
|
13,114
|
|
||
|
Investing activities
|
|
|
|
||||
|
Payments to CVR holders and other contingency payments
|
(4,998
|
)
|
|
(5,446
|
)
|
||
|
Purchases of property and equipment
|
(87
|
)
|
|
(238
|
)
|
||
|
Cash paid for acquisition, net of cash acquired
|
—
|
|
|
(92,855
|
)
|
||
|
Purchase of short-term investments
|
(73,352
|
)
|
|
(49,892
|
)
|
||
|
Proceeds from sale of short-term investments
|
17,719
|
|
|
20,270
|
|
||
|
Proceeds from maturity of short-term investments
|
30,052
|
|
|
48,401
|
|
||
|
Net cash used in investing activities
|
(30,666
|
)
|
|
(79,760
|
)
|
||
|
Financing activities
|
|
|
|
||||
|
Net proceeds from stock option exercises and ESPP
|
355
|
|
|
1,013
|
|
||
|
Taxes paid related to net share settlement of equity awards
|
(2,022
|
)
|
|
—
|
|
||
|
Share repurchase
|
—
|
|
|
(502
|
)
|
||
|
Net cash (used in) provided by financing activities
|
(1,667
|
)
|
|
511
|
|
||
|
Net decrease in cash and cash equivalents
|
(8,111
|
)
|
|
(66,135
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
18,752
|
|
|
97,428
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
10,641
|
|
|
$
|
31,293
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
||||
|
Interest paid
|
$
|
919
|
|
|
$
|
919
|
|
|
Taxes paid
|
96
|
|
|
1
|
|
||
|
Supplemental schedule of non-cash activity
|
|
|
|
||||
|
Stock issued for acquisition, net of issuance cost
|
—
|
|
|
(77,615
|
)
|
||
|
Accrued inventory purchases
|
3,909
|
|
|
600
|
|
||
|
Unrealized loss on AFS investments
|
(66
|
)
|
|
(1,834
|
)
|
||
|
|
March 31, 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
|
$
|
61,605
|
|
|
$
|
23
|
|
|
$
|
(10
|
)
|
|
$
|
61,618
|
|
|
$
|
40,715
|
|
|
$
|
19
|
|
|
$
|
—
|
|
|
$
|
40,734
|
|
|
Corporate bonds
|
32,237
|
|
|
2
|
|
|
(17
|
)
|
|
32,222
|
|
|
11,031
|
|
|
—
|
|
|
(5
|
)
|
|
11,026
|
|
||||||||
|
Commercial paper
|
23,328
|
|
|
1
|
|
|
(5
|
)
|
|
23,324
|
|
|
33,074
|
|
|
2
|
|
|
(9
|
)
|
|
33,067
|
|
||||||||
|
Agency bonds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,294
|
|
|
1
|
|
|
—
|
|
|
7,295
|
|
||||||||
|
U.S Government Bonds
|
11,020
|
|
|
—
|
|
|
(6
|
)
|
|
11,014
|
|
|
7,508
|
|
|
—
|
|
|
(1
|
)
|
|
7,507
|
|
||||||||
|
Municipal Bonds
|
18,143
|
|
|
2
|
|
|
(1
|
)
|
|
18,144
|
|
|
19,624
|
|
|
—
|
|
|
(11
|
)
|
|
19,613
|
|
||||||||
|
Corporate equity securities
|
300
|
|
|
2,111
|
|
|
—
|
|
|
2,411
|
|
|
1,512
|
|
|
1,542
|
|
|
—
|
|
|
3,054
|
|
||||||||
|
|
$
|
146,633
|
|
|
$
|
2,139
|
|
|
$
|
(39
|
)
|
|
$
|
148,733
|
|
|
$
|
120,758
|
|
|
$
|
1,564
|
|
|
$
|
(26
|
)
|
|
$
|
122,296
|
|
|
|
March 31,
|
|
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
|
(15,104
|
)
|
|
(12,792
|
)
|
||
|
Trade name
|
2,642
|
|
|
2,642
|
|
||
|
Less: Accumulated amortization
|
(817
|
)
|
|
(784
|
)
|
||
|
Customer relationships
|
29,600
|
|
|
29,600
|
|
||
|
Less: Accumulated amortization
|
(9,154
|
)
|
|
(8,784
|
)
|
||
|
Total goodwill and other identifiable intangible assets, net
|
$
|
274,197
|
|
|
$
|
276,912
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
CorMatrix
|
$
|
17,696
|
|
|
$
|
17,696
|
|
|
Selexis
|
8,602
|
|
|
8,602
|
|
||
|
|
26,298
|
|
|
26,298
|
|
||
|
Less: accumulated amortization
|
(668
|
)
|
|
(477
|
)
|
||
|
Total commercial license rights, net
|
$
|
25,630
|
|
|
$
|
25,821
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Compensation
|
$
|
1,356
|
|
|
$
|
2,603
|
|
|
Professional fees
|
799
|
|
|
829
|
|
||
|
Amounts owed to former licensees
|
890
|
|
|
899
|
|
||
|
Royalties owed to third parties
|
989
|
|
|
942
|
|
||
|
Other
|
646
|
|
|
1,124
|
|
||
|
Total accrued liabilities
|
$
|
4,680
|
|
|
$
|
6,397
|
|
|
|
Three months ended
|
||||||
|
|
March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Stock-based compensation expense as a component of:
|
|
|
|
||||
|
Research and development expenses
|
$
|
3,939
|
|
|
$
|
1,585
|
|
|
General and administrative expenses
|
2,106
|
|
|
2,533
|
|
||
|
|
$
|
6,045
|
|
|
$
|
4,118
|
|
|
|
Three months ended
|
||
|
|
March 31,
|
||
|
|
2017
|
|
2016
|
|
Risk-free interest rate
|
2.1%
|
|
1.5%
|
|
Dividend yield
|
—
|
|
—
|
|
Expected volatility
|
47%
|
|
50%
|
|
Expected term
|
6.9
|
|
6.6
|
|
|
Three months ended
|
||||
|
|
March 31,
|
||||
|
|
2017
|
|
2016
|
||
|
Weighted average shares outstanding:
|
20,937,627
|
|
|
20,707,926
|
|
|
Dilutive potential common shares:
|
|
|
|
||
|
Restricted stock
|
185,745
|
|
|
66,736
|
|
|
Stock options
|
954,509
|
|
|
759,581
|
|
|
2019 Convertible Senior Notes
|
941,308
|
|
|
749,736
|
|
|
Shares used to compute diluted income per share
|
23,019,189
|
|
|
22,283,979
|
|
|
Potentially dilutive shares excluded from calculation due to anti-dilutive effect
|
3,711,067
|
|
|
3,493,425
|
|
|
|
|
|
|
||
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Short-term investments
(1)
|
|
$
|
2,410
|
|
|
$
|
146,323
|
|
|
$
|
—
|
|
|
$
|
148,733
|
|
|
$
|
3,054
|
|
|
$
|
119,242
|
|
|
$
|
—
|
|
|
$
|
122,296
|
|
|
Note receivable Viking
(2)
|
|
—
|
|
|
—
|
|
|
3,207
|
|
|
3,207
|
|
|
—
|
|
|
—
|
|
|
3,207
|
|
|
3,207
|
|
||||||||
|
Investment in warrants
(3)
|
|
760
|
|
|
—
|
|
|
—
|
|
|
760
|
|
|
684
|
|
|
—
|
|
|
—
|
|
|
684
|
|
||||||||
|
Total assets
|
|
$
|
3,170
|
|
|
$
|
146,323
|
|
|
$
|
3,207
|
|
|
$
|
152,700
|
|
|
$
|
3,738
|
|
|
$
|
119,242
|
|
|
$
|
3,207
|
|
|
$
|
126,187
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Current contingent liabilities-CyDex
(4)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
111
|
|
|
$
|
111
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
101
|
|
|
$
|
101
|
|
|
Long-term contingent liabilities-CyDex
(4)
|
|
—
|
|
|
—
|
|
|
1,503
|
|
|
1,503
|
|
|
—
|
|
|
—
|
|
|
1,503
|
|
|
1,503
|
|
||||||||
|
Long-term contingent liabilities-Metabasis
(5)
|
|
—
|
|
|
1,532
|
|
|
—
|
|
|
1,532
|
|
|
—
|
|
|
1,413
|
|
|
—
|
|
|
1,413
|
|
||||||||
|
Liability for amounts owed to former licensees
(6)
|
|
362
|
|
|
—
|
|
|
—
|
|
|
362
|
|
|
371
|
|
|
—
|
|
|
—
|
|
|
371
|
|
||||||||
|
Total liabilities
|
|
$
|
362
|
|
|
$
|
1,532
|
|
|
$
|
1,614
|
|
|
$
|
3,508
|
|
|
$
|
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
March 31, 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.
|
|
|
March 31, 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%
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
|
2019 Convertible Senior Notes
|
|
|
|
||||
|
Principal amount outstanding
|
$
|
245,000
|
|
|
$
|
245,000
|
|
|
Unamortized discount
|
(29,252
|
)
|
|
(32,090
|
)
|
||
|
Total current portion of notes payable
|
$
|
215,748
|
|
|
$
|
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
|
180,765
|
|
|
100.81
|
|
|
64,155
|
|
|
100.91
|
|
||
|
Exercised
|
(29,412
|
)
|
|
17.42
|
|
|
(96,744
|
)
|
|
79.68
|
|
||
|
Forfeited
|
—
|
|
|
—
|
|
|
(300
|
)
|
|
97.92
|
|
||
|
Balance as of March 31, 2017
|
1,905,628
|
|
|
$
|
48.07
|
|
|
275,811
|
|
|
$
|
92.36
|
|
|
ITEM 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
•
|
Novartis reported first quarter 2017 net sales of Promacta/Revolade (eltrombopag) of $175 million, a $44 million or 34% 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 April 26, 2017, Amgen reported first quarter 2017 net sales of Kyprolis (carfilzomib) of $190 million, a $36 million or 23% increase over the same period in 2016.
|
|
•
|
On February 28, 2017, Amgen announced positive results from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial. The study met the key secondary endpoint of OS, demonstrating that patients with relapsed or refractory multiple myeloma treated with Kyprolis (carfilzomib) and dexamethasone (Kd) lived 7.6
|
|
•
|
On March 1, 2017, Amgen announced that new data from the Kyprolis (carfilzomib) clinical development program would be presented at the 16
th
International Myeloma Workshop, March 1-4, 2017, in New Delhi.
|
|
•
|
Melinta Therapeutics announced that the new drug applications (NDAs) for IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) were accepted for filing by the Food and Drug Administration (FDA) and were granted a Prescription Drug User Fee Act (PDUFA) date of June 19, 2017. Additionally, Melinta announced that the FDA does not plan to hold an Advisory Committee meeting for the NDAs. If approved, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela and a $1.5 million approval milestone payment.
|
|
•
|
Melinta Therapeutics announced signing a development and commercialization agreement with Menarini Group, granting Menarini exclusive rights to commercialize delafloxacin under its own brands in 68 countries in Europe, Asia-Pacific including China, South Korea and Australia (excluding Japan), and the Commonwealth of Independent States including Russia.
|
|
•
|
Retrophin announced plans to initiate a single Phase 3 clinical trial to enable an NDA filing for sparsentan for the treatment of focal segmental glomerulosclerosis. The trial will include an interim analysis of proteinuria as a surrogate endpoint to serve as the basis for an NDA filing for Subpart H accelerated approval of sparsentan. Retrophin expects to initiate the trial in the second half of 2017.
|
|
•
|
Sage Therapeutics presented brexanolone data at the American Academy of Neurology 2017 annual meeting.
|
|
•
|
Aldeyra provided an update on its Phase 3 clinical program of ADX-102 in noninfectious anterior uveitis and anticipates beginning the Phase 3 trial in the second quarter of 2017.
|
|
•
|
Aldeyra announced the last patient had completed dosing in Aldeyra's multicenter, double-blind, randomized Phase 2b clinical trial of ADX-102 in allergic conjunctivitis.
|
|
•
|
Biocad announced receiving marketing authorization from the Ministry of Health of the Russian Federation for its interferon beta-1a biosimilar of Merck’s Rebif
®
.
|
|
•
|
Merck announced it stopped the Phase 2/3 EPOCH study evaluating verubecestat in people with mild-to-moderate Alzheimer’s disease due to the conclusion that the efficacy endpoint could not be achieved. No safety concerns were noted. Results from EPOCH will be analyzed and presented at an upcoming scientific meeting. The external Data Monitoring Committee recommended that the ongoing Phase 3 APECS study, which is evaluating verubecestat in people with prodromal Alzheimer’s disease, continue unchanged. Results from the APECS study are expected in February 2019.
|
|
•
|
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.
|
|
•
|
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.
|
|
•
|
Viking Therapeutics announced positive initial results from a proof-of-concept study of VK2809 in an
in vivo
model of glycogen storage disease 1a (GSD 1a) and announced funding of initial clinical development of VK2809 for treatment of GSD 1a with plans to file an investigational new drug (IND) application in the second half of 2017.
|
|
•
|
Janssen filed an IND application for an antibody discovered using Ligand’s OmniAb technology. The IND filing resulted in a $1 million milestone payment to Ligand. Janssen has a royalty-free license to the OmniAb technology (entered into with OMT in October of 2013), but will potentially pay Ligand further development and commercial milestones upon clinical success and regulatory approval of any therapeutic developed using the OmniAb technology.
|
|
•
|
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.
|
|
•
|
Merck KGaA announced it licensed rights to develop Captisol-enabled VX-970 from Vertex Pharmaceuticals. Economic terms of the original agreement between Ligand and Vertex remained unchanged.
|
|
•
|
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.
|
|
•
|
Ligand announced a worldwide platform license agreement with bluebird bio, Inc. Under the license, bluebird will be able to use the OmniRat
®
, OmniMouse
®
and OmniFlic
®
platforms to discover fully human mono- and bispecific antibodies and antibody fragments. Ligand is eligible to receive annual platform access payments, development milestone payments
|
|
•
|
Ligand announced an expansion of its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world. Ligand is entitled to commercial milestones and royalties on net sales ranging from 6-10% upon commercialization of oral lasofoxifene.
|
|
•
|
Ligand announced a commercial license and supply agreement with Marinus Pharmaceuticals granting rights to use Captisol in the formulation of IV ganaxolone. Ligand is entitled to milestone payments, royalties and revenue from Captisol material sales related to IV ganaxolone.
|
|
•
|
Ligand entered into a Captisol Clinical Use/Supply Agreement with Eisai.
|
|
•
|
Ligand announced the completion of enrollment in the Company’s Phase 2 clinical trial with its novel, small-molecule GRA program (LGD-6972) for the treatment of type 2 diabetes mellitus. The Company expects to report topline results in September 2017.
|
|
(Dollars in thousands)
|
Q1 2017
|
|
Q1 2016
|
|
Change
|
|
% Change
|
|
|||||||
|
Royalties
|
$
|
24,230
|
|
|
$
|
14,390
|
|
|
$
|
9,840
|
|
|
68
|
%
|
|
|
Material sales
|
1,121
|
|
|
5,341
|
|
|
(4,220
|
)
|
|
(79
|
)%
|
|
|||
|
License fees, milestones and other revenue
|
3,916
|
|
|
9,917
|
|
|
(6,001
|
)
|
|
(61
|
)%
|
|
|||
|
Total revenue
|
$
|
29,267
|
|
|
$
|
29,648
|
|
|
$
|
(381
|
)
|
|
(1
|
)%
|
|
|
(Dollars in thousands)
|
Q1 2017
|
|
Q1 2016
|
|
Change
|
||||||
|
Costs of sales
|
$
|
341
|
|
|
$
|
955
|
|
|
$
|
(614
|
)
|
|
Amortization of intangibles
|
2,715
|
|
|
2,524
|
|
|
191
|
|
|||
|
Research and development
|
8,673
|
|
|
4,004
|
|
|
4,669
|
|
|||
|
General and administrative
|
7,322
|
|
|
7,069
|
|
|
253
|
|
|||
|
Total operating costs and expenses
|
$
|
19,051
|
|
|
$
|
14,552
|
|
|
$
|
4,499
|
|
|
(Dollars in thousands)
|
Q1 2017
|
|
Q1 2016
|
|
Change
|
||||||
|
Interest expense, net
|
$
|
(2,941
|
)
|
|
$
|
(3,005
|
)
|
|
$
|
64
|
|
|
Increase in contingent liabilities
|
(140
|
)
|
|
(1,306
|
)
|
|
1,166
|
|
|||
|
Loss from Viking
|
(1,083
|
)
|
|
(1,605
|
)
|
|
522
|
|
|||
|
Other income, net
|
141
|
|
|
391
|
|
|
(250
|
)
|
|||
|
Total other expense, net
|
$
|
(4,023
|
)
|
|
$
|
(5,525
|
)
|
|
$
|
1,502
|
|
|
(Dollars in thousands)
|
Q1 2017
|
|
Q1 2016
|
|
Change
|
||||||
|
Income before income taxes
|
$
|
6,193
|
|
|
$
|
9,571
|
|
|
$
|
(3,378
|
)
|
|
Income tax expense
|
(1,114
|
)
|
|
(3,694
|
)
|
|
2,580
|
|
|||
|
Income from operations
|
$
|
5,079
|
|
|
$
|
5,877
|
|
|
$
|
(798
|
)
|
|
Effective tax rate
|
18.0
|
%
|
|
38.6
|
%
|
|
|
|
|||
|
(Dollars in thousands)
|
Q1 2017
|
|
Q1 2016
|
|
Change
|
||||||
|
Net cash provided by (used in):
|
|
|
|
|
|
|
|||||
|
Operating activities
|
24,222
|
|
|
13,114
|
|
|
$
|
11,108
|
|
||
|
Investing activities
|
(30,666
|
)
|
|
(79,760
|
)
|
|
49,094
|
|
|||
|
Financing activities
|
(1,667
|
)
|
|
511
|
|
|
(2,178
|
)
|
|||
|
Net decrease in cash and cash equivalents
|
$
|
(8,111
|
)
|
|
$
|
(66,135
|
)
|
|
$
|
(2,178
|
)
|
|
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:
|
May 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
|
|
|
|
|
10.1
|
Third Amendment to Loan and Security Agreement with Viking
|
|
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
|
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 |
|---|