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Ireland
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000-28508
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98-1341933
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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Large accelerated filer
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¨
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Accelerated filer
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þ
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Non-accelerated
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¨
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(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Emerging growth company
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¨
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Page #
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Item 1.
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Item 2.
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Item 3.
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Item 4.
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Item 1.
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Item 1A.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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Three Months Ended June 30,
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Six Months Ended June 30,
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||||||||||||
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2017
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2016
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2017
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2016
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||||||||
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Revenues:
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||||||
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Product sales and services
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$
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47,105
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$
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38,165
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|
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$
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98,862
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|
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$
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73,518
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License and research revenue
|
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(794
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)
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693
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(44
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)
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1,556
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||||
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Total
|
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46,311
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38,858
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98,818
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75,074
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||||
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Operating expenses:
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||||
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Cost of products and services sold
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4,561
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3,907
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8,463
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|
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7,813
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||||
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Research and development expenses
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6,792
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7,604
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13,998
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12,992
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||||
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Selling, general and administrative expenses
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12,429
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11,290
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24,241
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20,751
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||||
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Intangible asset amortization
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564
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3,702
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1,128
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7,216
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||||
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Changes in fair value of related party contingent consideration
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(13,230
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)
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23,898
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(20,201
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)
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32,141
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||||
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Restructuring costs
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1,069
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—
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3,722
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—
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Total operating expenses
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12,185
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50,401
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31,351
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80,913
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||||
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Operating income (loss)
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34,126
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(11,543
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)
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67,467
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(5,839
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)
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||||
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Investment income, net
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527
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|
390
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1,579
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|
590
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||||
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Interest expense, net
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(263
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)
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(263
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)
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(526
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)
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(438
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)
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||||
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Other income (expense) - changes in fair value of related party payable
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1,670
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(2,773
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)
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2,220
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(4,307
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)
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||||
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Foreign exchange gain (loss)
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237
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1,680
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6
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(1,261
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)
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Income (loss) before income taxes
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36,297
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(12,509
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)
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70,746
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(11,255
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)
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Income tax provision
|
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7,370
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7,449
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15,909
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14,761
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Net income (loss)
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$
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28,927
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$
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(19,958
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)
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$
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54,837
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$
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(26,016
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)
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Net income (loss) per share - basic
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$
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0.70
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$
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(0.48
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)
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$
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1.33
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$
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(0.63
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)
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Net income (loss) per share - diluted
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0.68
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(0.48
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)
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1.29
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(0.63
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)
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Weighted average number of shares outstanding - basic
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41,091
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41,241
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41,233
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41,241
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Weighted average number of shares outstanding - diluted
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42,487
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41,241
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42,625
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41,241
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Three Months Ended June 30,
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Six Months Ended June 30,
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||||||||||||
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2017
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2016
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2017
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2016
|
||||||||
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Net income (loss)
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$
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28,927
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$
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(19,958
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)
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$
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54,837
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$
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(26,016
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)
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Other comprehensive income (loss), net of tax:
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Foreign currency translation gain (loss)
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117
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(2,457
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)
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247
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2,360
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Net other comprehensive income, net of ($26), ($73), ($92) and $(158) tax, respectively
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594
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528
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638
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1,447
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||||
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Total other comprehensive income (loss), net of tax
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711
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(1,929
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)
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885
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3,807
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||||
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Total comprehensive income (loss)
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$
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29,638
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$
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(21,887
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)
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$
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55,722
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|
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$
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(22,209
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)
|
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|
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June 30, 2017
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|
December 31, 2016
|
||||
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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43,507
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$
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39,215
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Marketable securities
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130,290
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|
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114,980
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|
||
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Accounts receivable
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19,285
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|
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17,839
|
|
||
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Inventories
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5,747
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3,258
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|
||
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Prepaid expenses and other current assets
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5,522
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|
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5,894
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|
||
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Total current assets
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204,351
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181,186
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|
||
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Property and equipment, net
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3,328
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3,320
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|
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Goodwill
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18,491
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18,491
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|
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Intangible assets, net
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21,709
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|
|
22,837
|
|
||
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Research and development tax credit receivable
|
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3,039
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|
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1,775
|
|
||
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Income tax deferred charge
|
|
—
|
|
|
10,342
|
|
||
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Other
|
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8,242
|
|
|
7,531
|
|
||
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Total assets
|
|
$
|
259,160
|
|
|
$
|
245,482
|
|
|
|
|
|
|
|
||||
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
||
|
Current liabilities:
|
|
|
|
|
|
|
||
|
Current portion of long-term debt
|
|
$
|
291
|
|
|
$
|
268
|
|
|
Current portion of long-term related party payable
|
|
40,615
|
|
|
34,177
|
|
||
|
Accounts payable
|
|
12,321
|
|
|
7,105
|
|
||
|
Deferred revenue
|
|
2,455
|
|
|
2,223
|
|
||
|
Accrued expenses
|
|
30,339
|
|
|
17,222
|
|
||
|
Income taxes
|
|
1,455
|
|
|
1,200
|
|
||
|
Other
|
|
1,233
|
|
|
226
|
|
||
|
Total current liabilities
|
|
88,709
|
|
|
62,421
|
|
||
|
Long-term debt, less current portion
|
|
594
|
|
|
547
|
|
||
|
Long-term related party payable, less current portion
|
|
86,844
|
|
|
135,170
|
|
||
|
Other
|
|
6,285
|
|
|
5,275
|
|
||
|
Total liabilities
|
|
182,432
|
|
|
203,413
|
|
||
|
|
|
|
|
|
||||
|
Shareholders' equity:
|
|
|
|
|
|
|
||
|
Preferred shares, $0.01 nominal value; 50,000 shares authorized; none issued or outstanding at June 30, 2017 and December 31, 2016, respectively
|
|
—
|
|
|
—
|
|
||
|
Ordinary shares, nominal value of $0.01; 500,000 shares authorized; 41,435 and 41,371 issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
|
414
|
|
|
414
|
|
||
|
Treasury shares, at cost, 1,351 and 0 shares held at June 30, 2017 and December 31, 2016, respectively
|
|
(14,338
|
)
|
|
—
|
|
||
|
Additional paid-in capital
|
|
389,451
|
|
|
385,020
|
|
||
|
Accumulated deficit
|
|
(276,119
|
)
|
|
(319,800
|
)
|
||
|
Accumulated other comprehensive loss
|
|
(22,680
|
)
|
|
(23,565
|
)
|
||
|
Total shareholders' equity
|
|
76,728
|
|
|
42,069
|
|
||
|
Total liabilities and shareholders' equity
|
|
$
|
259,160
|
|
|
$
|
245,482
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
|
||||
|
Cash flows from operating activities:
|
|
|
|
|
|
|
||
|
Net income (loss)
|
|
$
|
54,837
|
|
|
$
|
(26,016
|
)
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
|
||
|
Depreciation and amortization
|
|
1,611
|
|
|
7,681
|
|
||
|
Loss on disposal of property and equipment
|
|
—
|
|
|
110
|
|
||
|
Loss (gain) on sale of marketable securities
|
|
(81
|
)
|
|
455
|
|
||
|
Foreign exchange loss
|
|
1,304
|
|
|
1,261
|
|
||
|
Grants recognized in research and development expenses
|
|
—
|
|
|
(70
|
)
|
||
|
Remeasurement of related party acquisition-related contingent consideration
|
|
(20,201
|
)
|
|
32,141
|
|
||
|
Remeasurement of related party financing-related contingent consideration
|
|
(2,220
|
)
|
|
4,307
|
|
||
|
Change in deferred tax and income tax deferred charge
|
|
322
|
|
|
(5,028
|
)
|
||
|
Stock-based compensation expense
|
|
4,055
|
|
|
4,913
|
|
||
|
Increase (decrease) in cash from:
|
|
|
|
|
|
|
||
|
Accounts receivable
|
|
(1,446
|
)
|
|
(1,689
|
)
|
||
|
Inventories
|
|
(2,489
|
)
|
|
2,345
|
|
||
|
Prepaid expenses and other current assets
|
|
(264
|
)
|
|
546
|
|
||
|
Research and development tax credit receivable
|
|
(1,175
|
)
|
|
(1,630
|
)
|
||
|
Accounts payable & other current liabilities
|
|
4,931
|
|
|
(348
|
)
|
||
|
Deferred revenue
|
|
232
|
|
|
(1,461
|
)
|
||
|
Accrued expenses
|
|
12,747
|
|
|
777
|
|
||
|
Accrued income taxes
|
|
255
|
|
|
6,285
|
|
||
|
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value
|
|
(16,515
|
)
|
|
(7,769
|
)
|
||
|
Royalty payments for related party payable in excess of original fair value
|
|
(2,287
|
)
|
|
(1,159
|
)
|
||
|
Other long-term assets and liabilities
|
|
(80
|
)
|
|
270
|
|
||
|
Net cash provided by operating activities
|
|
33,536
|
|
|
15,921
|
|
||
|
|
|
|
|
|
||||
|
Cash flows from investing activities:
|
|
|
|
|
|
|
||
|
Purchases of property and equipment
|
|
(321
|
)
|
|
(760
|
)
|
||
|
Acquisitions of businesses
|
|
—
|
|
|
161
|
|
||
|
Proceeds from sales of marketable securities
|
|
51,820
|
|
|
26,013
|
|
||
|
Purchases of marketable securities
|
|
(67,743
|
)
|
|
(75,528
|
)
|
||
|
Net cash used in investing activities
|
|
(16,244
|
)
|
|
(50,114
|
)
|
||
|
|
|
|
|
|
||||
|
Cash flows from financing activities:
|
|
|
|
|
|
|
||
|
Earn-out payments for related party contingent consideration
|
|
(665
|
)
|
|
(6,572
|
)
|
||
|
Royalty payments for related party payable
|
|
—
|
|
|
(816
|
)
|
||
|
Reimbursement of loans
|
|
12
|
|
|
—
|
|
||
|
Cash proceeds from issuance of ordinary shares and warrants
|
|
376
|
|
|
—
|
|
||
|
Share repurchases
|
|
(13,081
|
)
|
|
—
|
|
||
|
Net cash used in financing activities
|
|
(13,358
|
)
|
|
(7,388
|
)
|
||
|
|
|
|
|
|
||||
|
Effect of foreign currency exchange rate changes on cash and cash equivalents
|
|
358
|
|
|
416
|
|
||
|
|
|
|
|
|
||||
|
Net increase (decrease) in cash and cash equivalents
|
|
4,292
|
|
|
(41,165
|
)
|
||
|
Cash and cash equivalents at January 1,
|
|
39,215
|
|
|
65,064
|
|
||
|
Cash and cash equivalents at June 30,
|
|
$
|
43,507
|
|
|
$
|
23,899
|
|
|
•
|
the development of differentiated, patent protected products through application of the Company’s proprietary patented drug delivery platforms, Micropump® and LiquiTime®, that target high-value solid, liquid oral and alternative dosage forms through the U.S. Food and Drug Administration (FDA) 505(b)(2) approval process, which allows a sponsor to submit an application that doesn’t depend on efficacy, safety, and toxicity data created by the sponsor. In addition to Micropump® and LiquiTime®, the Company has two other proprietary drug delivery platforms, Medusa™ (hydrogel depot technology for use with large molecules and peptides) and Trigger Lock™ (controlled release of opioid analgesics with potential abuse deterrent properties).
|
|
•
|
the identification of Unapproved Marketed Drugs (“UMDs”), which are currently sold in the U.S., but unapproved by the FDA, and the pursuit of approval for these products via a 505(b)(2) New Drug Application (NDA). To date, the Company has received three drug approvals through this “unapproved-to-approved” strategy, including: Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection) and Akovaz® (ephedrine sulfate injection). As a potential source of near-term revenue growth, Avadel is working on the development of a fourth product for potential NDA submission and seeks to identify additional product candidates for development with this strategy.
|
|
•
|
the acquisition of commercial and or late-stage products or businesses. The Company markets three branded pediatric-focused pharmaceutical products in the primary care space, and a 510(k) approved device all of which were purchased through the acquisition of FSC Laboratories and FSC Pediatrics ("FSC") on February 5, 2016. We will consider further acquisitions and the Company continues to look for assets that could fit strategically into our current or potential future commercial sales force.
|
|
•
|
Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel.
|
|
•
|
our authorized share capital is
$5,500
divided into
500,000
ordinary shares with a nominal value of
$0.01
each and
50,000
preferred shares with a nominal value of
$0.01
each
|
|
◦
|
all outstanding ordinary shares of Flamel,
€0.122
nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company,
$0.01
nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying
$5,937
on our balance sheet from ordinary shares to additional paid-in capital
|
|
◦
|
our Board of Directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point it may be renewed by shareholders. The Board of Directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation.
|
|
•
|
all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company.
|
|
•
|
Income approach, which is based on the present value of a future stream of net cash flows.
|
|
•
|
Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.
|
|
•
|
Level 1 - Quoted prices for identical assets or liabilities in active markets.
|
|
•
|
Level 2 - Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means.
|
|
•
|
Level 3 - Unobservable inputs that reflect estimates and assumptions.
|
|
|
|
As of June 30, 2017
|
|
As of December 31, 2016
|
||||||||||||||||||||
|
Fair Value Measurements:
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Marketable securities (see Note 4)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Equity securities
|
|
$
|
12,307
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,033
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Money market funds
|
|
1,503
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Corporate bonds
|
|
—
|
|
|
67,706
|
|
|
—
|
|
|
—
|
|
|
57,348
|
|
|
—
|
|
||||||
|
Government securities - U.S.
|
|
—
|
|
|
37,546
|
|
|
—
|
|
|
—
|
|
|
42,814
|
|
|
—
|
|
||||||
|
Government securities - Non-U.S.
|
|
—
|
|
|
243
|
|
|
—
|
|
|
—
|
|
|
233
|
|
|
—
|
|
||||||
|
Other fixed-income securities
|
|
—
|
|
|
10,985
|
|
|
—
|
|
|
—
|
|
|
10,471
|
|
|
—
|
|
||||||
|
Other securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
81
|
|
|
—
|
|
||||||
|
Total assets
|
|
$
|
13,810
|
|
|
$
|
116,480
|
|
|
$
|
—
|
|
|
$
|
4,033
|
|
|
$
|
110,947
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Related party payables (see Note 7)
|
|
—
|
|
|
—
|
|
|
127,459
|
|
|
—
|
|
|
—
|
|
|
169,347
|
|
||||||
|
Total liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
127,459
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
169,347
|
|
|
|
|
As of June 30, 2017
|
||||||||||||||
|
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Equity securities
|
|
$
|
11,413
|
|
|
$
|
1,109
|
|
|
$
|
(215
|
)
|
|
$
|
12,307
|
|
|
Money market funds
|
|
1,500
|
|
|
3
|
|
|
—
|
|
|
1,503
|
|
||||
|
Corporate bonds
|
|
67,797
|
|
|
232
|
|
|
(323
|
)
|
|
67,706
|
|
||||
|
Government securities - U.S.
|
|
37,964
|
|
|
30
|
|
|
(448
|
)
|
|
37,546
|
|
||||
|
Government securities - Non-U.S.
|
|
246
|
|
|
—
|
|
|
(3
|
)
|
|
243
|
|
||||
|
Other fixed-income securities
|
|
11,004
|
|
|
2
|
|
|
(21
|
)
|
|
10,985
|
|
||||
|
Total
|
|
$
|
129,924
|
|
|
$
|
1,376
|
|
|
$
|
(1,010
|
)
|
|
$
|
130,290
|
|
|
|
|
As of December 31, 2016
|
||||||||||||||
|
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Equity securities
|
|
$
|
3,689
|
|
|
$
|
409
|
|
|
$
|
(65
|
)
|
|
$
|
4,033
|
|
|
Corporate bonds
|
|
57,871
|
|
|
89
|
|
|
(612
|
)
|
|
57,348
|
|
||||
|
Government securities - U.S.
|
|
43,049
|
|
|
515
|
|
|
(750
|
)
|
|
42,814
|
|
||||
|
Government securities - Non-U.S.
|
|
247
|
|
|
—
|
|
|
(14
|
)
|
|
233
|
|
||||
|
Other fixed-income securities
|
|
10,281
|
|
|
221
|
|
|
(31
|
)
|
|
10,471
|
|
||||
|
Other securities
|
|
81
|
|
|
—
|
|
|
—
|
|
|
81
|
|
||||
|
Total
|
|
$
|
115,218
|
|
|
$
|
1,234
|
|
|
$
|
(1,472
|
)
|
|
$
|
114,980
|
|
|
|
|
Maturities
|
||||||||||||||||||
|
Marketable Debt Securities:
|
|
Less than 1 Year
|
|
1-5 Years
|
|
5-10 Years
|
|
Greater than 10 Years
|
|
Total
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Corporate bonds
|
|
18,194
|
|
|
44,855
|
|
|
4,280
|
|
|
377
|
|
|
67,706
|
|
|||||
|
Government securities - U.S.
|
|
1,001
|
|
|
26,706
|
|
|
1,189
|
|
|
8,650
|
|
|
37,546
|
|
|||||
|
Government securities - Non-U.S.
|
|
—
|
|
|
—
|
|
|
243
|
|
|
—
|
|
|
243
|
|
|||||
|
Other fixed-income securities
|
|
—
|
|
|
8,919
|
|
|
2,066
|
|
|
—
|
|
|
10,985
|
|
|||||
|
Total
|
|
$
|
19,195
|
|
|
$
|
80,480
|
|
|
$
|
7,778
|
|
|
$
|
9,027
|
|
|
$
|
116,480
|
|
|
Inventory:
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
|
|
|
|
|
||||
|
Finished goods
|
|
$
|
4,059
|
|
|
$
|
2,429
|
|
|
Raw materials
|
|
1,688
|
|
|
829
|
|
||
|
Total
|
|
$
|
5,747
|
|
|
$
|
3,258
|
|
|
|
|
As of June 30, 2017
|
|
As of December 31, 2016
|
||||||||||||||||||||
|
Goodwill and Intangible Assets:
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Acquired developed technology - Vazculep
|
|
$
|
12,061
|
|
|
$
|
(9,207
|
)
|
|
$
|
2,854
|
|
|
$
|
12,061
|
|
|
$
|
(8,801
|
)
|
|
$
|
3,260
|
|
|
Acquired product marketing rights
|
|
16,600
|
|
|
(1,576
|
)
|
|
15,024
|
|
|
16,600
|
|
|
(1,019
|
)
|
|
15,581
|
|
||||||
|
Acquired developed technology
|
|
4,300
|
|
|
(469
|
)
|
|
3,831
|
|
|
4,300
|
|
|
(304
|
)
|
|
3,996
|
|
||||||
|
Total amortizable intangible assets
|
|
$
|
32,961
|
|
|
$
|
(11,252
|
)
|
|
$
|
21,709
|
|
|
$
|
32,961
|
|
|
$
|
(10,124
|
)
|
|
$
|
22,837
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Unamortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Goodwill
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
Total unamortizable intangible assets
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
Estimated Amortization Expense:
|
|
Amount
|
||
|
|
|
|
||
|
2017
|
|
$
|
2,258
|
|
|
2018
|
|
2,258
|
|
|
|
2019
|
|
2,258
|
|
|
|
2020
|
|
2,258
|
|
|
|
2021
|
|
1,443
|
|
|
|
|
|
Activity during the Three Months Ended June 30, 2017
|
|
|
|||||||||||||||
|
|
|
|
|
|
Changes in Fair Value of
Related Party Payable
|
|
|
||||||||||||
|
Long-Term Related Party Payable:
|
Balance,
March 31, 2017
|
|
Payments
to Related Parties
|
|
Operating
Expense / (Income)
|
|
Other
Expense / (Income)
|
|
Balance, June 30, 2017
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Warrants - Éclat Pharmaceuticals (a)
|
$
|
8,188
|
|
|
$
|
—
|
|
|
$
|
2,212
|
|
|
$
|
—
|
|
|
$
|
10,400
|
|
|
Earn-out payments - Éclat Pharmaceuticals (b)
|
109,931
|
|
|
(9,349
|
)
|
|
(16,488
|
)
|
|
—
|
|
|
84,094
|
|
|||||
|
Royalty agreement - FSC (c)
|
7,185
|
|
|
(221
|
)
|
|
1,046
|
|
|
—
|
|
|
8,010
|
|
|||||
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Royalty agreement - Deerfield (d)
|
8,743
|
|
|
(869
|
)
|
|
—
|
|
|
(1,131
|
)
|
|
6,743
|
|
|||||
|
Royalty agreement - Broadfin (e)
|
4,166
|
|
|
(415
|
)
|
|
—
|
|
|
(539
|
)
|
|
3,212
|
|
|||||
|
Long-term liability - FSC (f)
|
15,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15,000
|
|
|||||
|
Total related party payable
|
153,213
|
|
|
$
|
(10,854
|
)
|
|
$
|
(13,230
|
)
|
|
$
|
(1,670
|
)
|
|
127,459
|
|
||
|
Less: Current portion
|
(43,699
|
)
|
|
|
|
|
|
|
|
|
|
|
(40,615
|
)
|
|||||
|
Total long-term related party payable
|
$
|
109,514
|
|
|
|
|
|
|
|
|
|
|
|
$
|
86,844
|
|
|||
|
|
|
Activity during the Six Months Ended June 30, 2017
|
|
|
|||||||||||||||
|
|
|
|
|
|
Changes in Fair Value of
Related Party Payable
|
|
|
||||||||||||
|
Long-Term Related Party Payable:
|
Balance, December 31, 2016
|
|
Payments to
Related Parties
|
|
Operating
Expense / (Income)
|
|
Other
Expense / (Income)
|
|
Balance, June 30, 2017
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Warrants - Éclat Pharmaceuticals (a)
|
$
|
11,217
|
|
|
$
|
—
|
|
|
$
|
(817
|
)
|
|
$
|
—
|
|
|
$
|
10,400
|
|
|
Earn-out payments - Éclat Pharmaceuticals (b)
|
121,377
|
|
|
(16,515
|
)
|
|
(20,768
|
)
|
|
—
|
|
|
84,094
|
|
|||||
|
Royalty agreement - FSC (c)
|
7,291
|
|
|
(665
|
)
|
|
1,384
|
|
|
—
|
|
|
8,010
|
|
|||||
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Royalty agreement - Deerfield (d)
|
9,794
|
|
|
(1,548
|
)
|
|
—
|
|
|
(1,503
|
)
|
|
6,743
|
|
|||||
|
Royalty agreement - Broadfin (e)
|
4,668
|
|
|
(739
|
)
|
|
—
|
|
|
(717
|
)
|
|
3,212
|
|
|||||
|
Long-term liability - FSC (f)
|
15,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15,000
|
|
|||||
|
Total related party payable
|
169,347
|
|
|
$
|
(19,467
|
)
|
|
$
|
(20,201
|
)
|
|
$
|
(2,220
|
)
|
|
127,459
|
|
||
|
Less: Current portion
|
(34,177
|
)
|
|
|
|
|
|
|
|
|
|
|
(40,615
|
)
|
|||||
|
Total long-term related party payable
|
$
|
135,170
|
|
|
|
|
|
|
|
|
|
|
|
$
|
86,844
|
|
|||
|
(a)
|
As part of the consideration for the Company’s acquisition of Éclat on March 13, 2012, the Company issued
two
warrants to a related party with a
six
-year term which allow for the purchase of a combined total of
3,300
ordinary shares of Avadel. One warrant is exercisable for
2,200
shares at an exercise price of
$7.44
per share, and the other warrant is exercisable for
1,100
shares at an exercise price of
$11.00
per share.
|
|
Assumptions for the Warrant Valuation:
|
|
June 30, 2017
|
|
June 30, 2016
|
||||
|
|
|
|
|
|
||||
|
Stock price
|
|
$
|
11.03
|
|
|
$
|
10.74
|
|
|
Weighted average exercise price per share
|
|
8.63
|
|
|
8.63
|
|
||
|
Expected term (years)
|
|
0.75
|
|
|
1.75
|
|
||
|
Expected volatility
|
|
42.80
|
%
|
|
69.70
|
%
|
||
|
Risk-free interest rate
|
|
1.19
|
%
|
|
0.55
|
%
|
||
|
Expected dividend yield
|
|
—
|
|
|
—
|
|
||
|
(b)
|
In March 2012, the Company acquired all of the membership interests of Éclat from Breaking Stick Holdings, L.L.C. (“Breaking Stick”, formerly Éclat Holdings), an affiliate of Deerfield. Breaking Stick is majority owned by Deerfield, with a minority interest owned by the Company’s CEO, and certain other current and former employees. As part of the consideration, the Company committed to provide quarterly earn-out payments equal to
20%
of any gross profit generated by certain Éclat products. These payments will continue in perpetuity, to the extent gross profit of the related products also continue in perpetuity.
|
|
(c)
|
In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part included a commitment to pay quarterly a
15%
royalty on the net sales of certain FSC products, up to
$12,500
for a period not exceeding
ten
years.
|
|
(d)
|
As part of a February 2013 debt financing transaction conducted with Deerfield, the Company received cash of
$2,600
in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a
1.75%
royalty on the net sales of certain Éclat products until December 31, 2024. In connection with such debt financing transaction, the Company granted Deerfield a security interest in the product registration rights of the Eclat products.
|
|
(e)
|
As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund, a related party and current shareholder, the Company received cash of
$2,200
in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a
0.834%
royalty on the net sales of certain Éclat products until December 31, 2024.
|
|
(f)
|
In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part consists of payments totaling
$1,050
annually for
five
years with a final payment in January 2021 of
$15,000
. Substantially all of FSC's, and its subsidiaries, assets are pledged as collateral under this agreement.
|
|
Related Party Payable Rollforward:
|
|
Balance
|
|
|
|
|
|
|
|
Balance at December 31, 2015
|
|
122,693
|
|
|
Additions
(2)
|
|
22,695
|
|
|
Payment of related party payable
|
|
(16,315
|
)
|
|
Fair value adjustments
(1)
|
|
36,448
|
|
|
Balance at June 30, 2016
|
|
165,521
|
|
|
|
|
|
|
|
Balance at December 31, 2016
|
|
169,347
|
|
|
Payment of related party payable
|
|
(19,467
|
)
|
|
Fair value adjustments
(1)
|
|
(22,421
|
)
|
|
Balance at June 30, 2017
|
|
127,459
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Income (Loss) Before Income Taxes:
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Ireland
|
|
$
|
2,300
|
|
|
$
|
(8,034
|
)
|
|
$
|
8,035
|
|
|
$
|
(13,928
|
)
|
|
United States
|
|
34,651
|
|
|
(2,187
|
)
|
|
66,661
|
|
|
11,762
|
|
||||
|
France
|
|
(1,038
|
)
|
|
(2,288
|
)
|
|
(5,263
|
)
|
|
(9,089
|
)
|
||||
|
Other
|
|
384
|
|
|
—
|
|
|
1,313
|
|
|
—
|
|
||||
|
Total income before income taxes
|
|
$
|
36,297
|
|
|
$
|
(12,509
|
)
|
|
$
|
70,746
|
|
|
$
|
(11,255
|
)
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Income Tax Rate Reconciliation:
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Statutory tax rate
|
|
12.5
|
%
|
|
33.3
|
%
|
|
12.5
|
%
|
|
33.3
|
%
|
||||
|
International tax rates differential
|
|
20.4
|
%
|
|
(13.2
|
)%
|
|
18.7
|
%
|
|
(27.7
|
)%
|
||||
|
Change in valuation allowance
|
|
0.6
|
%
|
|
(11.9
|
)%
|
|
1.3
|
%
|
|
(34.8
|
)%
|
||||
|
Nondeductible change in fair value of contingent consideration
|
|
(13.1
|
)%
|
|
(64.2
|
)%
|
|
(10.2
|
)%
|
|
(96.0
|
)%
|
||||
|
Other
|
|
(0.1
|
)%
|
|
(3.6
|
)%
|
|
0.2
|
%
|
|
(6.1
|
)%
|
||||
|
Effective income tax rate
|
|
20.3
|
%
|
|
(59.6
|
)%
|
|
22.5
|
%
|
|
(131.3
|
)%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Income tax provision - at statutory tax rate
|
|
$
|
4,537
|
|
|
$
|
(4,165
|
)
|
|
$
|
8,843
|
|
|
$
|
(3,748
|
)
|
|
International tax rates differential
|
|
7,399
|
|
|
1,647
|
|
|
13,259
|
|
|
3,115
|
|
||||
|
Change in valuation allowance
|
|
230
|
|
|
1,485
|
|
|
914
|
|
|
3,913
|
|
||||
|
Nondeductible change in fair value of contingent consideration
|
|
(4,757
|
)
|
|
8,029
|
|
|
(7,232
|
)
|
|
10,800
|
|
||||
|
Other
|
|
(39
|
)
|
|
453
|
|
|
125
|
|
|
681
|
|
||||
|
Income tax provision - at effective income tax rate
|
|
$
|
7,370
|
|
|
$
|
7,449
|
|
|
$
|
15,909
|
|
|
$
|
14,761
|
|
|
Prepaid Expenses and Other Current Assets:
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
|
|
|
|
|
||||
|
Valued-added tax recoverable
|
|
$
|
1,059
|
|
|
$
|
736
|
|
|
Prepaid expenses
|
|
3,061
|
|
|
3,442
|
|
||
|
Advance to suppliers and other current assets
|
|
814
|
|
|
1,265
|
|
||
|
Income tax receivable
|
|
588
|
|
|
451
|
|
||
|
Total
|
|
$
|
5,522
|
|
|
$
|
5,894
|
|
|
Other Non-Current Assets:
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
|
|
|
|
|
||||
|
Deferred tax assets
|
|
$
|
7,110
|
|
|
$
|
7,432
|
|
|
Other
|
|
1,132
|
|
|
99
|
|
||
|
Total
|
|
$
|
8,242
|
|
|
$
|
7,531
|
|
|
Accrued Expenses:
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
|
|
|
|
|
||||
|
Accrued compensation
|
|
$
|
3,170
|
|
|
$
|
3,291
|
|
|
Accrued social charges
|
|
924
|
|
|
794
|
|
||
|
Accrued employee severance (see Note 10)
|
|
3,922
|
|
|
—
|
|
||
|
Customer allowances
|
|
20,496
|
|
|
7,981
|
|
||
|
Accrued amounts due to contract research organization
|
|
—
|
|
|
1,764
|
|
||
|
Other
|
|
1,827
|
|
|
3,392
|
|
||
|
Total
|
|
$
|
30,339
|
|
|
$
|
17,222
|
|
|
Other Non-Current Liabilities:
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
|
|
|
|
|
|
||||
|
Provision for retirement indemnity
|
|
$
|
2,577
|
|
|
$
|
2,431
|
|
|
Customer allowances
|
|
1,074
|
|
|
905
|
|
||
|
Unrecognized tax benefits
|
|
2,456
|
|
|
1,565
|
|
||
|
Other
|
|
178
|
|
|
374
|
|
||
|
Total
|
|
$
|
6,285
|
|
|
$
|
5,275
|
|
|
Severance Obligation:
|
|
2017
|
||
|
|
|
|
||
|
Balance of accrued costs at January 1,
|
|
$
|
—
|
|
|
Charges for employee severance, benefits and other
|
|
3,722
|
|
|
|
Payments
|
|
—
|
|
|
|
Foreign currency impact
|
|
200
|
|
|
|
Balance of accrued costs at June 30,
|
|
$
|
3,922
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Net Income (Loss) Per Share:
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss)
|
|
$
|
28,927
|
|
|
$
|
(19,958
|
)
|
|
$
|
54,837
|
|
|
$
|
(26,016
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic shares
|
|
41,091
|
|
|
41,241
|
|
|
41,233
|
|
|
41,241
|
|
||||
|
Effect of dilutive securities—options and warrants outstanding
|
|
1,396
|
|
|
—
|
|
|
1,392
|
|
|
—
|
|
||||
|
Diluted shares
|
|
42,487
|
|
|
41,241
|
|
|
42,625
|
|
|
41,241
|
|
||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss) per share - basic
|
|
$
|
0.70
|
|
|
$
|
(0.48
|
)
|
|
$
|
1.33
|
|
|
$
|
(0.63
|
)
|
|
Net income (loss) per share - diluted
|
|
$
|
0.68
|
|
|
$
|
(0.48
|
)
|
|
$
|
1.29
|
|
|
$
|
(0.63
|
)
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Accumulated Other Comprehensive Loss:
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency translation adjustment:
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Beginning balance
|
|
$
|
(23,206
|
)
|
|
$
|
(17,495
|
)
|
|
$
|
(23,336
|
)
|
|
$
|
(22,312
|
)
|
|
Net other comprehensive income (loss)
|
|
117
|
|
|
(2,457
|
)
|
|
247
|
|
|
2,360
|
|
||||
|
Balance at June 30,
|
|
$
|
(23,089
|
)
|
|
$
|
(19,952
|
)
|
|
$
|
(23,089
|
)
|
|
$
|
(19,952
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Unrealized gain (loss) on marketable securities, net
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Beginning balance
|
|
$
|
(185
|
)
|
|
$
|
574
|
|
|
$
|
(229
|
)
|
|
$
|
(345
|
)
|
|
Net other comprehensive income, net of ($26), ($73), ($92) and ($158) tax, respectively
|
|
594
|
|
|
528
|
|
|
638
|
|
|
1,447
|
|
||||
|
Balance at June 30,
|
|
$
|
409
|
|
|
$
|
1,102
|
|
|
$
|
409
|
|
|
$
|
1,102
|
|
|
Accumulated other comprehensive loss at June 30,
|
|
$
|
(22,680
|
)
|
|
$
|
(18,850
|
)
|
|
$
|
(22,680
|
)
|
|
$
|
(18,850
|
)
|
|
Shareholders' Equity:
|
|
2017
|
||
|
|
|
|
||
|
Shareholders' equity - January 1,
|
|
$
|
42,069
|
|
|
Net income
|
|
54,837
|
|
|
|
Adjustment to accumulated deficit (see Note 2)
|
|
(11,156
|
)
|
|
|
Other comprehensive income
|
|
885
|
|
|
|
Stock option exercised
|
|
376
|
|
|
|
Stock-based compensation expense
|
|
4,055
|
|
|
|
Share repurchases
|
|
(14,338
|
)
|
|
|
Shareholders' equity - June 30,
|
|
$
|
76,728
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Revenues by Product:
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Bloxiverz
|
|
$
|
13,719
|
|
|
$
|
25,620
|
|
|
$
|
27,621
|
|
|
$
|
50,367
|
|
|
Vazculep
|
|
10,154
|
|
|
10,421
|
|
|
20,334
|
|
|
19,827
|
|
||||
|
Akovaz
|
|
20,912
|
|
|
—
|
|
|
46,549
|
|
|
—
|
|
||||
|
Other
|
|
2,320
|
|
|
2,124
|
|
|
4,358
|
|
|
3,324
|
|
||||
|
Total product sales and services
|
|
47,105
|
|
|
38,165
|
|
|
98,862
|
|
|
73,518
|
|
||||
|
License and research revenue
|
|
(794
|
)
|
|
693
|
|
|
(44
|
)
|
|
1,556
|
|
||||
|
Total revenues
|
|
$
|
46,311
|
|
|
$
|
38,858
|
|
|
$
|
98,818
|
|
|
$
|
75,074
|
|
|
•
|
the development of differentiated, patent protected products through application of the Company’s proprietary patented drug delivery platforms, Micropump® and LiquiTime®, that target high-value solid and liquid oral and alternative dosages forms through the U.S. Food and Drug Administration (FDA) 505(b)(2) approval process, which allows a sponsor to submit an application that doesn’t depend on efficacy, safety, and toxicity data created by the sponsor. In addition to Micropump® and LiquiTime®, the Company has two other proprietary drug delivery platforms, Medusa™ (hydrogel depot technology for use with large molecules and peptides) and Trigger Lock™ (controlled release of opioid analgesics with potential abuse deterrent properties).
|
|
•
|
the identification of Unapproved Marketed Drugs (“UMDs”), which are currently sold in the U.S., but unapproved by the FDA, and the pursuit of approval for these products via a 505(b)(2) New Drug Application (NDA). To date, the Company has received approvals through this “unapproved-to-approved” avenue for three products: Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection) and Akovaz® (ephedrine sulfate injection). As a potential source of near-term revenue growth, Avadel is working on the development of a fourth product for potential NDA submission and seeks to identify additional product candidates for development with this strategy.
|
|
•
|
the acquisition of commercial and or late-stage products or businesses. The Company markets three branded pediatric-focused pharmaceutical products in the primary care space, and a 510(k) approved device that launched in the second quarter of 2017, all of which were purchased through the acquisition of FSC Laboratories and FSC Pediatrics on February 5, 2016. We will consider further acquisitions and the Company continues to look for assets that could fit strategically into our current or potential future commercial sales force.
|
|
•
|
Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel.
|
|
•
|
our authorized share capital is $5,500 divided into 500,000 ordinary shares with a nominal value of $0.01 each and 50,000 preferred shares with a nominal value of $0.01 each
|
|
◦
|
all outstanding ordinary shares of Flamel, €0.122 nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company, $0.01 nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying $5,937 on our balance sheet from ordinary shares to additional paid-in capital
|
|
◦
|
our Board of Directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point it may be renewed by shareholders. The Board of Directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation.
|
|
•
|
all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company.
|
|
•
|
Unapproved Marketed Drug Development
: The Company derives a majority of our sales and cash flow from our UMD products. During the three months ended
June 30, 2017
the Company generated
$44,785
of sales from the UMD products compared to
$36,041
in the same period of
2016
, respectively. During the
six
months ended
June 30, 2017
the Company generated
$94,504
of sales from the UMD products compared to
$70,194
in the same period of
2016
, respectively.
|
|
◦
|
The first UMD product, Bloxiverz, which had sales of
$13,719
and
$27,621
for the three and
six
months ended
June 30, 2017
, respectively, was approved by the FDA on May 31, 2013, and is currently being marketed in the U.S.
|
|
◦
|
The second UMD product, Vazculep, which had sales of
$10,154
and
$20,334
for the three and
six
months ended
June 30, 2017
, respectively, was approved by the FDA on September 27, 2014 and launched in October 2014 in the U.S.
|
|
◦
|
The third UMD product, Akovaz, which had sales of
$20,912
and
$46,549
for the three and
six
months ended
June 30, 2017
, respectively, was approved by the FDA April 29, 2016. The Company began marketing this product in August 2016.
|
|
•
|
Development and Commercialization of the Company’s Drug Delivery Pipeline Products
: In addition to the UMD strategy, the Company is continuing to advance the development of our innovative drug delivery platforms. We have enhanced our ability to identify new product candidates and to pursue commercial opportunities associated with our drug delivery platforms. The Company’s drug delivery platforms allow the creation of competitive and differentiated drug product profiles (e.g., with improved pharmacokinetics, efficacy and/or safety). We own and develop drug delivery platforms that address key formulation challenges, leading to the development of differentiated drug products for administration in various forms (e.g., capsules, tablets, sachets or liquid suspensions for oral use; or injectables for subcutaneous administration) and can be applied to a broad range of drugs (novel, already-marketed, or off-patent). Application of these technologies to pharmaceuticals allows us to protect our potential products through patent protection and product differentiation. As a result of developing our own drug delivery platforms our business is now less dependent on the development activities performed by partners, and relies more on the development of our own, self-funded, products. Our proprietary drug delivery platforms include:
|
|
◦
|
Micropump®
is a microparticulate system that allows the development and marketing of modified and/or controlled release solid oral dosage formulations of drugs (Micropump®-carvedilol and Micropump®-aspirin formulations have been approved in the U.S. and in the E.U., respectively).
|
|
◦
|
LiquiTime®
allows development of modified/controlled release oral products in a liquid suspension formulation particularly suited to children or patients having issues swallowing tablets or capsules. Unlike most liquid pharmaceuticals, LiquiTime® technology is not limited to ionic drugs as with resin-complex based technologies and can be applied to the development of combination products.
|
|
◦
|
Trigger Lock™
allows development of abuse-deterrent modified/controlled release formulations of narcotic/opioid analgesics and other drugs susceptible to abuse.
|
|
◦
|
Medusa™
allows the development of extended/modified release of injectable dosage formulations of drugs (
e.g.,
peptides, polypeptides, proteins, and small molecules).
|
|
◦
|
Continuing to build commercially successful products utilizing Micropump;
|
|
◦
|
Identifying opportunities and optimizing time-to-market for our LiquiTime drug delivery platform;
|
|
◦
|
Maximizing the technical potential of our existing drug delivery platforms for developing new and proprietary products; and
|
|
◦
|
Developing and validating improved and complementary drug delivery platforms related to our current drug delivery capabilities.
|
|
•
|
Inorganic growth through Acquisitions and/or Partnerships:
The Company maintains a strong balance sheet with substantial liquidity and no long-term debt with fixed maturities. As part of our overall enterprise strategy, the Company expects to explore and pursue appropriate inorganic growth opportunities that complement our drug delivery platforms or to acquire proprietary products that enhance profitability and cash flow. This was evidenced in early 2016 with the acquisition of FSC, a specialty pharmaceutical company dedicated to providing innovative solutions to unmet medical needs for pediatric patients. Additionally, the Company will leverage the capabilities of our existing and future proprietary products and/or drug delivery platforms with pharmaceutical and biotechnology partnerships or licensing transactions. In 2015, the Company completed a licensing transaction for exclusive U.S. rights to our LiquiTime technology-based Over-the-Counter ("OTC") products which was licensed to Elan Pharma International Limited.
|
|
•
|
Divestitures and out licensing:
We have a stated objective to narrow our focus to our two most developed platforms, Micropump® and LiquiTime®. As a result, we are pursuing the divestiture or out licensing of Trigger Lock™ for abuse deterrence, and Medusa™ for extended-release subcutaneous injection. We believe both platforms are robust and well protected from an IP standpoint; however, their development and FDA approval will likely require substantial investments in clinical work and infrastructure, which we are not currently prepared to support.
|
|
•
|
Healthcare and Regulatory Reform
: Various health care reform laws in the U.S. may impact our ability to successfully commercialize our products and technologies. The success of our commercialization efforts may depend on the extent to which the government health administration authorities, the health insurance funds in the E.U. Member States, private health insurers and other third party payers in the U.S. will reimburse consumers for the cost of healthcare products and services.
|
|
•
|
Competition and Technological Change:
Competition in the pharmaceutical and biotechnology industry continues to be intense and is expected to increase. We compete with academic laboratories, research institutions, universities, joint ventures, and other pharmaceutical and biotechnology companies, including other companies developing niche branded or generic specialty pharmaceutical products or drug delivery platforms. Furthermore, major technological changes can happen quickly in the pharmaceutical and biotechnology industries. Such rapid technological change, or the development by our competitors of technologically improved or differentiated products, could render our drug delivery platforms obsolete or noncompetitive.
|
|
•
|
Pricing Environment for Pharmaceuticals
: The pricing environment continues to be in the political spotlight in the U.S. As a result, the need to obtain and maintain appropriate pricing and reimbursement for our products may become more challenging due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the U.S. and worldwide.
|
|
•
|
Generics Playing a Larger Role in Healthcare
: Generic pharmaceutical products will continue to play a large role in the U.S. healthcare system. Specifically, we have seen, or likely will see, additional generic competition to our current and future products and we continue to expect generic competition in the future.
|
|
•
|
Access to and Cost of Capital
: The cost of raising capital has recently become more expensive. If the need were to arise to raise more capital our cost will be more expensive and may create challenges for the Company. Currently, the Company has no need to raise capital.
|
|
•
|
Revenue was
$46,311
and
$98,818
for the three and
six
months ended
June 30, 2017
, compared to
$38,858
and
$75,074
in the same period last year, respectively. This increase was primarily the result of additional Akovaz revenue which was launched in August 2016, partially offset by a decrease in Bloxiverz sales volume and net selling price as a result of additional competition.
|
|
•
|
Operating income was
$34,126
and
$67,467
for the three and
six
months ended
June 30, 2017
, compared to operating loss of
$11,543
and
$5,839
for the same period last year, respectively. The primary reasons for the increase in operating income for the three months ended June 30, 2017 were changes in the fair value of related party contingent consideration and the gross margin on $8,940 of higher product sales and services. The company recognized a
$13,230
gain resulting
|
|
•
|
Net income was
$28,927
and
$54,837
for the three and
six
months ended
June 30, 2017
, compared to a net loss of
$19,958
and
$26,016
in the same period last year, respectively.
|
|
•
|
Diluted net income per share was
$0.68
and
$1.29
for the three and
six
months ended
June 30, 2017
, compared to a diluted net loss per share of
$0.48
and
$0.63
in the same period last year, respectively.
|
|
•
|
Cash and marketable securities increased
$19,602
to
$173,797
at
June 30, 2017
, from
$154,195
at
December 31, 2016
.
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Comparative Statements of Income (Loss)
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Product sales and services
|
|
$
|
47,105
|
|
|
$
|
38,165
|
|
|
$
|
8,940
|
|
|
23.4
|
%
|
|
License and research revenue
|
|
(794
|
)
|
|
693
|
|
|
(1,487
|
)
|
|
(214.6
|
)%
|
|||
|
Total revenues
|
|
46,311
|
|
|
38,858
|
|
|
7,453
|
|
|
19.2
|
%
|
|||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
Cost of products and services sold
|
|
4,561
|
|
|
3,907
|
|
|
654
|
|
|
16.7
|
%
|
|||
|
Research and development expenses
|
|
6,792
|
|
|
7,604
|
|
|
(812
|
)
|
|
(10.7
|
)%
|
|||
|
Selling, general and administrative expenses
|
|
12,429
|
|
|
11,290
|
|
|
1,139
|
|
|
10.1
|
%
|
|||
|
Intangible asset amortization
|
|
564
|
|
|
3,702
|
|
|
(3,138
|
)
|
|
(84.8
|
)%
|
|||
|
Changes in fair value of related party contingent consideration
|
|
(13,230
|
)
|
|
23,898
|
|
|
(37,128
|
)
|
|
(155.4
|
)%
|
|||
|
Restructuring costs
|
|
1,069
|
|
|
—
|
|
|
1,069
|
|
|
n/a
|
|
|||
|
Total operating expenses
|
|
12,185
|
|
|
50,401
|
|
|
(38,216
|
)
|
|
(75.8
|
)%
|
|||
|
Operating income (loss)
|
|
34,126
|
|
|
(11,543
|
)
|
|
45,669
|
|
|
(395.6
|
)%
|
|||
|
Investment income
|
|
527
|
|
|
390
|
|
|
137
|
|
|
35.1
|
%
|
|||
|
Interest expense
|
|
(263
|
)
|
|
(263
|
)
|
|
—
|
|
|
—
|
%
|
|||
|
Other income (expense) - changes in fair value of related party payable
|
|
1,670
|
|
|
(2,773
|
)
|
|
4,443
|
|
|
160.2
|
%
|
|||
|
Foreign exchange loss
|
|
237
|
|
|
1,680
|
|
|
(1,443
|
)
|
|
(85.9
|
)%
|
|||
|
Income (loss) before income taxes
|
|
36,297
|
|
|
(12,509
|
)
|
|
48,806
|
|
|
390.2
|
%
|
|||
|
Income tax provision
|
|
7,370
|
|
|
7,449
|
|
|
(79
|
)
|
|
(1.1
|
)%
|
|||
|
Net income (loss)
|
|
$
|
28,927
|
|
|
$
|
(19,958
|
)
|
|
$
|
48,885
|
|
|
244.9
|
%
|
|
Income (loss) per share - diluted
|
|
$
|
0.68
|
|
|
$
|
(0.48
|
)
|
|
$
|
1.16
|
|
|
241.7
|
%
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Comparative Statements of Income (Loss)
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Product sales and services
|
|
$
|
98,862
|
|
|
$
|
73,518
|
|
|
$
|
25,344
|
|
|
34.5
|
%
|
|
License and research revenue
|
|
(44
|
)
|
|
1,556
|
|
|
(1,600
|
)
|
|
(102.8
|
)%
|
|||
|
Total revenues
|
|
98,818
|
|
|
75,074
|
|
|
23,744
|
|
|
31.6
|
%
|
|||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Cost of products and services sold
|
|
8,463
|
|
|
7,813
|
|
|
650
|
|
|
8.3
|
%
|
|||
|
Research and development expenses
|
|
13,998
|
|
|
12,992
|
|
|
1,006
|
|
|
7.7
|
%
|
|||
|
Selling, general and administrative expenses
|
|
24,241
|
|
|
20,751
|
|
|
3,490
|
|
|
16.8
|
%
|
|||
|
Intangible asset amortization
|
|
1,128
|
|
|
7,216
|
|
|
(6,088
|
)
|
|
(84.4
|
)%
|
|||
|
Changes in fair value of related party contingent consideration
|
|
(20,201
|
)
|
|
32,141
|
|
|
(52,342
|
)
|
|
(162.9
|
)%
|
|||
|
Restructuring costs
|
|
3,722
|
|
|
—
|
|
|
3,722
|
|
|
n/a
|
|
|||
|
Total operating expenses
|
|
31,351
|
|
|
80,913
|
|
|
(49,562
|
)
|
|
(61.3
|
)%
|
|||
|
Operating income (loss)
|
|
67,467
|
|
|
(5,839
|
)
|
|
73,306
|
|
|
(1,255.5
|
)%
|
|||
|
Investment income
|
|
1,579
|
|
|
590
|
|
|
989
|
|
|
167.6
|
%
|
|||
|
Interest expense
|
|
(526
|
)
|
|
(438
|
)
|
|
(88
|
)
|
|
20.1
|
%
|
|||
|
Other income (expense) - changes in fair value of related party payable
|
|
2,220
|
|
|
(4,307
|
)
|
|
6,527
|
|
|
151.5
|
%
|
|||
|
Foreign exchange loss
|
|
6
|
|
|
(1,261
|
)
|
|
1,267
|
|
|
(100.5
|
)%
|
|||
|
Income (loss) before income taxes
|
|
70,746
|
|
|
(11,255
|
)
|
|
82,001
|
|
|
728.6
|
%
|
|||
|
Income tax provision
|
|
15,909
|
|
|
14,761
|
|
|
1,148
|
|
|
7.8
|
%
|
|||
|
Net income (loss)
|
|
$
|
54,837
|
|
|
$
|
(26,016
|
)
|
|
$
|
80,853
|
|
|
310.8
|
%
|
|
Income (loss) per share - diluted
|
|
$
|
1.29
|
|
|
$
|
(0.63
|
)
|
|
$
|
1.92
|
|
|
304.8
|
%
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Revenues:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Bloxiverz
|
|
$
|
13,719
|
|
|
$
|
25,620
|
|
|
$
|
(11,901
|
)
|
|
(46.5
|
)%
|
|
Vazculep
|
|
10,154
|
|
|
10,421
|
|
|
(267
|
)
|
|
(2.6
|
)%
|
|||
|
Akovaz
|
|
20,912
|
|
|
—
|
|
|
20,912
|
|
|
n/a
|
|
|||
|
Other
|
|
2,320
|
|
|
2,124
|
|
|
196
|
|
|
9.2
|
%
|
|||
|
Total product sales and services
|
|
47,105
|
|
|
38,165
|
|
|
8,940
|
|
|
23.4
|
%
|
|||
|
License and research revenue
|
|
(794
|
)
|
|
693
|
|
|
(1,487
|
)
|
|
(214.6
|
)%
|
|||
|
Total revenues
|
|
$
|
46,311
|
|
|
$
|
38,858
|
|
|
$
|
7,453
|
|
|
19.2
|
%
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Revenues:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Bloxiverz
|
|
$
|
27,621
|
|
|
$
|
50,367
|
|
|
(22,746
|
)
|
|
(45.2
|
)%
|
|
|
Vazculep
|
|
20,334
|
|
|
19,827
|
|
|
507
|
|
|
2.6
|
%
|
|||
|
Akovaz
|
|
46,549
|
|
|
—
|
|
|
46,549
|
|
|
n/a
|
|
|||
|
Other
|
|
4,358
|
|
|
3,324
|
|
|
1,034
|
|
|
31.1
|
%
|
|||
|
Total product sales and services
|
|
98,862
|
|
|
73,518
|
|
|
25,344
|
|
|
34.5
|
%
|
|||
|
License and research revenue
|
|
(44
|
)
|
|
1,556
|
|
|
(1,600
|
)
|
|
(102.8
|
)%
|
|||
|
Total revenues
|
|
$
|
98,818
|
|
|
$
|
75,074
|
|
|
$
|
23,744
|
|
|
31.6
|
%
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Cost of Products and Services Sold:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Cost of products and services sold
|
|
$
|
4,561
|
|
|
$
|
3,907
|
|
|
$
|
654
|
|
|
16.7
|
%
|
|
Percentage of sales
|
|
9.8
|
%
|
|
10.1
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Cost of Products and Services Sold:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Cost of products and services sold
|
|
$
|
8,463
|
|
|
$
|
7,813
|
|
|
$
|
650
|
|
|
8.3
|
%
|
|
Percentage of sales
|
|
8.6
|
%
|
|
10.4
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Research and Development Expenses:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Research and development expenses
|
|
$
|
6,792
|
|
|
$
|
7,604
|
|
|
$
|
(812
|
)
|
|
(10.7
|
)%
|
|
Percentage of sales
|
|
14.7
|
%
|
|
19.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Research and Development Expenses:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Research and development expenses
|
|
$
|
13,998
|
|
|
$
|
12,992
|
|
|
$
|
1,006
|
|
|
7.7
|
%
|
|
Percentage of sales
|
|
14.2
|
%
|
|
17.3
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Selling, General and Administrative Expenses:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Selling, general and administrative expenses
|
|
$
|
12,429
|
|
|
$
|
11,290
|
|
|
$
|
1,139
|
|
|
10.1
|
%
|
|
Percentage of sales
|
|
26.8
|
%
|
|
29.1
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Selling, General and Administrative Expenses:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Selling, general and administrative expenses
|
|
$
|
24,241
|
|
|
$
|
20,751
|
|
|
$
|
3,490
|
|
|
16.8
|
%
|
|
Percentage of sales
|
|
24.5
|
%
|
|
27.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Intangibles Asset Amortization:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Intangible asset amortization
|
|
$
|
564
|
|
|
$
|
3,702
|
|
|
$
|
(3,138
|
)
|
|
(84.8
|
)%
|
|
Percentage of sales
|
|
1.2
|
%
|
|
9.5
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Intangibles Asset Amortization:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Intangible asset amortization
|
|
$
|
1,128
|
|
|
$
|
7,216
|
|
|
$
|
(6,088
|
)
|
|
(84.4
|
)%
|
|
Percentage of sales
|
|
1.1
|
%
|
|
9.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Changes in Fair Value of Related Party Contingent Consideration:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Changes in fair value of related party contingent consideration
|
|
$
|
(13,230
|
)
|
|
$
|
23,898
|
|
|
$
|
(37,128
|
)
|
|
(155.4
|
)%
|
|
Percentage of sales
|
|
(28.6
|
)%
|
|
61.5
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Changes in Fair Value of Related Party Contingent Consideration:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Changes in fair value of related party contingent consideration
|
|
$
|
(20,201
|
)
|
|
$
|
32,141
|
|
|
$
|
(52,342
|
)
|
|
(162.9
|
)%
|
|
Percentage of sales
|
|
(20.4
|
)%
|
|
42.8
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
||||||||||
|
|
|
|
2017 vs. 2016
|
|||||||||||
|
Restructuring Costs
|
|
2017
|
|
2016
|
|
$
|
|
%
|
||||||
|
|
|
|
|
|
|
|
|
|
||||||
|
Restructuring costs
|
|
$
|
1,069
|
|
|
$
|
—
|
|
|
$
|
1,069
|
|
|
n/a
|
|
Percentage of sales
|
|
2.3
|
%
|
|
—
|
%
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||
|
Restructuring Costs
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||
|
|
|
|
|
|
|
|
|
|
|||||
|
Restructuring costs
|
|
$
|
3,722
|
|
|
$
|
—
|
|
|
3,722
|
|
|
n/a
|
|
Percentage of sales
|
|
3.8
|
%
|
|
—
|
%
|
|
|
|
|
|
||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Other Income (Expense) - Changes in Fair Value of Related Party Payable
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Changes in fair value of related party contingent consideration
|
|
$
|
1,670
|
|
|
$
|
(2,773
|
)
|
|
$
|
4,443
|
|
|
160.2
|
%
|
|
Percentage of sales
|
|
3.6
|
%
|
|
(7.1
|
)%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Other Income (Expense) - Changes in Fair Value of Related Party Payable
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Changes in fair value of related party contingent consideration
|
|
$
|
2,220
|
|
|
$
|
(4,307
|
)
|
|
$
|
6,527
|
|
|
151.5
|
%
|
|
Percentage of sales
|
|
2.2
|
%
|
|
(5.7
|
)%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Income Tax Provision:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Income tax provision
|
|
$
|
7,370
|
|
|
$
|
7,449
|
|
|
$
|
(79
|
)
|
|
(1.1
|
)%
|
|
Percentage of income (loss) before income taxes
|
|
(20.3
|
)%
|
|
59.5
|
%
|
|
|
|
|
|
|
|||
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
|
||||
|
Statutory tax rate
|
|
12.5
|
%
|
|
33.3
|
%
|
||
|
International tax rates differential
|
|
20.4
|
%
|
|
(13.2
|
)%
|
||
|
Valuation allowance on net operating losses
|
|
0.6
|
%
|
|
(11.9
|
)%
|
||
|
Nondeductible contingent consideration
|
|
(13.1
|
)%
|
|
(64.2
|
)%
|
||
|
Other
|
|
(0.1
|
)%
|
|
(3.6
|
)%
|
||
|
Effective income tax rate
|
|
20.3
|
%
|
|
(59.6
|
)%
|
||
|
|
|
|
|
|
||||
|
Income tax provision - at statutory tax rate
|
|
$
|
4,537
|
|
|
$
|
(4,165
|
)
|
|
International tax rates differential
|
|
7,399
|
|
|
1,647
|
|
||
|
Valuation allowance on net operating losses
|
|
230
|
|
|
1,485
|
|
||
|
Nondeductible contingent consideration
|
|
(4,757
|
)
|
|
8,029
|
|
||
|
Other
|
|
(39
|
)
|
|
453
|
|
||
|
Income tax provision - at effective income tax rate
|
|
$
|
7,370
|
|
|
$
|
7,449
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Income Tax Provision:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Income tax provision
|
|
$
|
15,909
|
|
|
$
|
14,761
|
|
|
$
|
1,148
|
|
|
7.8
|
%
|
|
Percentage of income (loss) before income taxes
|
|
(22.5
|
)%
|
|
131.2
|
%
|
|
|
|
|
|
|
|||
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2017
|
|
2016
|
||||
|
|
|
|
|
|
||||
|
Statutory tax rate
|
|
12.5
|
%
|
|
33.3
|
%
|
||
|
International tax rates differential
|
|
18.7
|
%
|
|
(27.7
|
)%
|
||
|
Valuation allowance on net operating losses
|
|
1.3
|
%
|
|
(34.8
|
)%
|
||
|
Nondeductible contingent consideration
|
|
(10.2
|
)%
|
|
(96.0
|
)%
|
||
|
Other
|
|
0.2
|
%
|
|
(6.1
|
)%
|
||
|
Effective income tax rate
|
|
22.5
|
%
|
|
(131.3
|
)%
|
||
|
|
|
|
|
|
||||
|
Income tax provision - at statutory tax rate
|
|
$
|
8,843
|
|
|
$
|
(3,748
|
)
|
|
International tax rates differential
|
|
13,259
|
|
|
3,115
|
|
||
|
Valuation allowance on net operating losses
|
|
914
|
|
|
3,913
|
|
||
|
Nondeductible contingent consideration
|
|
(7,232
|
)
|
|
10,800
|
|
||
|
Other
|
|
125
|
|
|
681
|
|
||
|
Income tax provision - at effective income tax rate
|
|
$
|
15,909
|
|
|
$
|
14,761
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2017 vs. 2016
|
||||||||||||
|
Net cash provided by (used in):
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Operating activities
|
|
$
|
33,536
|
|
|
$
|
15,921
|
|
|
$
|
17,615
|
|
|
110.6
|
%
|
|
Investing activities
|
|
(16,244
|
)
|
|
(50,114
|
)
|
|
33,870
|
|
|
67.6
|
%
|
|||
|
Financing activities
|
|
(13,358
|
)
|
|
(7,388
|
)
|
|
(5,970
|
)
|
|
(80.8
|
)%
|
|||
|
ITEM 1.
|
LEGAL PROCEEDINGS.
|
|
|
|
Total Number of Shares Purchased
|
|
Average Price Paid Per Share
|
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Number (or Approximate Dollar Value) of Shares That May Yet Be Purchased Under Plans or Programs
|
||||||
|
|
|
|
|
|
|
|
|
|
||||||
|
April 2017
|
|
—
|
|
|
$
|
—
|
|
|
|
|
$
|
25,000
|
|
|
|
May 2017
|
|
316
|
|
|
9.94
|
|
|
316
|
|
|
21,864
|
|
||
|
June 2017
|
|
1,035
|
|
|
10.82
|
|
|
1,035
|
|
|
10,662
|
|
||
|
Total
|
|
1,351
|
|
|
|
|
|
|
|
|||||
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
31.1*
|
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) promulgated under the Exchange Act.
|
|
31.2*
|
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) promulgated under the Exchange Act.
|
|
32.1**
|
|
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2**
|
|
Certification of the 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
|
|
|
AVADEL PHARMACEUTICALS PLC
|
|
|
|
(Registrant)
|
|
|
|
|
|
|
Date: August 9, 2017
|
By:
|
/s/ Michael F. Kanan
|
|
|
|
Michael F. Kanan
|
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
|
(Duly Authorized Officer
and
Principal Financial Officer)
|
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 |
|---|