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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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Smaller reporting company
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¨
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(Do not check if a smaller reporting company)
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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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2018
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2017
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2018
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2017
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||||||||
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Revenues:
|
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||||||
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Product sales
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$
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29,116
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$
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47,105
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|
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$
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62,277
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|
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$
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98,862
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License revenue
|
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114
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(794
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)
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246
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|
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(44
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)
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||||
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Total revenues
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29,230
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46,311
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62,523
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98,818
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||||
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Operating expenses:
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||||
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Cost of products
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3,512
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4,561
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10,104
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8,463
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||||
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Research and development expenses
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11,890
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6,792
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21,841
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13,998
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||||
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Selling, general and administrative expenses
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27,843
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12,429
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52,330
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24,241
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||||
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Intangible asset amortization
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1,609
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564
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3,376
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1,128
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Gain - changes in fair value of related party contingent consideration
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(12,889
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)
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(13,230
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)
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(9,921
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)
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(20,201
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)
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||||
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Restructuring costs
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50
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1,069
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203
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3,722
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||||
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Total operating expenses
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32,015
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12,185
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77,933
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31,351
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Operating (loss) income
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(2,785
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)
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34,126
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(15,410
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)
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67,467
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||||
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Investment and other income (expense), net
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583
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764
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637
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1,585
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||||
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Interest expense, net
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(2,980
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)
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(263
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)
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(4,577
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)
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(526
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)
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||||
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Other income - changes in fair value of related party payable
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1,402
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1,670
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1,007
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2,220
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(Loss) income before income taxes
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(3,780
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)
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36,297
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(18,343
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)
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70,746
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||||
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Income tax (benefit) provision
|
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(342
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)
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7,370
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(2,669
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)
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15,909
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||||
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Net (loss) income
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$
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(3,438
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)
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$
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28,927
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$
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(15,674
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)
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$
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54,837
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Net (loss) income per share - basic
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$
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(0.09
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)
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$
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0.70
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$
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(0.42
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)
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$
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1.33
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Net (loss) income per share - diluted
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(0.09
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)
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0.68
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(0.42
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)
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1.29
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||||
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Weighted average number of shares outstanding - basic
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36,772
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41,091
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37,666
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41,233
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Weighted average number of shares outstanding - diluted
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36,772
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42,487
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37,666
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42,625
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Three Months Ended June 30,
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Six Months Ended June 30,
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2018
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2017
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2018
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2017
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||||||||
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Net (loss) income
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$
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(3,438
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)
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$
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28,927
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$
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(15,674
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)
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$
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54,837
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Other comprehensive (loss) income, net of tax:
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Foreign currency translation (loss) gain
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(482
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)
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117
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(233
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)
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247
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||||
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Net other comprehensive income (loss), net of ($11), ($26), ($70) and ($92) tax, respectively
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78
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594
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(160
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)
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638
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||||
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Total other comprehensive (loss) income, net of tax
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(404
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)
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711
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(393
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)
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885
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||||
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Total comprehensive (loss) income
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$
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(3,842
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)
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$
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29,638
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$
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(16,067
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)
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$
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55,722
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June 30, 2018
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December 31, 2017
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||||
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ASSETS
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|
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Current assets:
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Cash and cash equivalents
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$
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12,477
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$
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16,564
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Marketable securities
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134,629
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77,511
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Accounts receivable
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14,940
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14,785
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Inventories
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5,724
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6,157
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|
||
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Prepaid expenses and other current assets
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7,206
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|
|
8,958
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|
||
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Total current assets
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174,976
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|
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123,975
|
|
||
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Property and equipment, net
|
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2,439
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|
3,001
|
|
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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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70,962
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|
|
92,289
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|
||
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Research and development tax credit receivable
|
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6,124
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5,272
|
|
||
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Other non-current assets
|
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22,244
|
|
|
10,249
|
|
||
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Total assets
|
|
$
|
295,236
|
|
|
$
|
253,277
|
|
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|
||||
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LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
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|
||
|
Current liabilities:
|
|
|
|
|
|
|
||
|
Current portion of long-term debt
|
|
$
|
108
|
|
|
$
|
111
|
|
|
Current portion of long-term related party payable
|
|
14,067
|
|
|
25,007
|
|
||
|
Accounts payable
|
|
11,169
|
|
|
7,477
|
|
||
|
Deferred revenue
|
|
1,724
|
|
|
2,007
|
|
||
|
Accrued expenses
|
|
21,493
|
|
|
50,926
|
|
||
|
Other current liabilities
|
|
3,052
|
|
|
1,011
|
|
||
|
Total current liabilities
|
|
51,613
|
|
|
86,539
|
|
||
|
Long-term debt, less current portion
|
|
113,038
|
|
|
156
|
|
||
|
Long-term related party payable, less current portion
|
|
38,050
|
|
|
73,918
|
|
||
|
Other non-current liabilities
|
|
13,989
|
|
|
7,084
|
|
||
|
Total liabilities
|
|
216,690
|
|
|
167,697
|
|
||
|
|
|
|
|
|
||||
|
Shareholders’ equity:
|
|
|
|
|
|
|
||
|
Preferred shares, $0.01 nominal value; 50,000 shares authorized at June 30, 2018 and December 31, 2017, respectively; none issued or outstanding at June 30, 2018 and December 31, 2017, respectively
|
|
—
|
|
|
—
|
|
||
|
Ordinary shares, nominal value of $0.01; 500,000 shares authorized; 42,148 issued and 36,740 outstanding at June 30, 2018 and 41,463 issued and 39,346 outstanding at December 31, 2017
|
|
421
|
|
|
414
|
|
||
|
Treasury shares, at cost, 5,408 and 2,117 shares held at June 30, 2018 and December 31, 2017, respectively
|
|
(49,998
|
)
|
|
(22,361
|
)
|
||
|
Additional paid-in capital
|
|
430,141
|
|
|
393,478
|
|
||
|
Accumulated deficit
|
|
(278,359
|
)
|
|
(262,685
|
)
|
||
|
Accumulated other comprehensive loss
|
|
(23,659
|
)
|
|
(23,266
|
)
|
||
|
Total shareholders’ equity
|
|
78,546
|
|
|
85,580
|
|
||
|
Total liabilities and shareholders’ equity
|
|
$
|
295,236
|
|
|
$
|
253,277
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
Cash flows from operating activities:
|
|
|
|
|
|
|
||
|
Net (loss) income
|
|
$
|
(15,674
|
)
|
|
$
|
54,837
|
|
|
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
|
|
|
|
|
|
|
||
|
Depreciation and amortization
|
|
3,810
|
|
|
1,611
|
|
||
|
Amortization of premiums on marketable securities
|
|
1,693
|
|
|
34
|
|
||
|
Foreign exchange loss
|
|
(160
|
)
|
|
1,304
|
|
||
|
Remeasurement of related party acquisition-related contingent consideration
|
|
(9,921
|
)
|
|
(20,201
|
)
|
||
|
Remeasurement of related party financing-related contingent consideration
|
|
(1,007
|
)
|
|
(2,220
|
)
|
||
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Amortization of debt discount and debt issuance costs
|
|
2,019
|
|
|
—
|
|
||
|
Change in deferred tax and income tax deferred charge
|
|
(3,247
|
)
|
|
322
|
|
||
|
Stock-based compensation expense
|
|
4,358
|
|
|
4,055
|
|
||
|
Other adjustments
|
|
251
|
|
|
(115
|
)
|
||
|
Net changes in assets and liabilities
|
|
|
|
|
|
|
||
|
Accounts receivable
|
|
(157
|
)
|
|
(1,446
|
)
|
||
|
Inventories
|
|
(242
|
)
|
|
(2,489
|
)
|
||
|
Prepaid expenses and other current assets
|
|
1,587
|
|
|
(264
|
)
|
||
|
Research and development tax credit receivable
|
|
(1,003
|
)
|
|
(1,175
|
)
|
||
|
Accounts payable & other current liabilities
|
|
5,206
|
|
|
4,931
|
|
||
|
Accrued expenses
|
|
(9,831
|
)
|
|
12,747
|
|
||
|
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value
|
|
(11,113
|
)
|
|
(16,515
|
)
|
||
|
Royalty payments for related party payable in excess of original fair value
|
|
(1,618
|
)
|
|
(2,287
|
)
|
||
|
Other assets and liabilities
|
|
(2,893
|
)
|
|
407
|
|
||
|
Net cash (used in) provided by operating activities
|
|
(37,942
|
)
|
|
33,536
|
|
||
|
|
|
|
|
|
||||
|
Cash flows from investing activities:
|
|
|
|
|
|
|
||
|
Purchases of property and equipment
|
|
(99
|
)
|
|
(321
|
)
|
||
|
Purchase of intangible asset
|
|
(20,000
|
)
|
|
—
|
|
||
|
Proceeds from sales of marketable securities
|
|
253,525
|
|
|
51,820
|
|
||
|
Purchases of marketable securities
|
|
(312,638
|
)
|
|
(67,743
|
)
|
||
|
Net cash used in investing activities
|
|
(79,212
|
)
|
|
(16,244
|
)
|
||
|
|
|
|
|
|
||||
|
Cash flows from financing activities:
|
|
|
|
|
|
|
||
|
Earn-out payments for related party contingent consideration
|
|
(645
|
)
|
|
(665
|
)
|
||
|
Proceeds from debt issuance
|
|
143,750
|
|
|
—
|
|
||
|
Payments for debt issuance costs
|
|
(5,760
|
)
|
|
—
|
|
||
|
Share repurchases
|
|
(27,637
|
)
|
|
(13,081
|
)
|
||
|
Cash proceeds from the issuance of ordinary shares and warrants
|
|
3,446
|
|
|
376
|
|
||
|
Other financing activities, net
|
|
6
|
|
|
12
|
|
||
|
Net cash provided by (used in) financing activities
|
|
113,160
|
|
|
(13,358
|
)
|
||
|
|
|
|
|
|
||||
|
Effect of foreign currency exchange rate changes on cash and cash equivalents
|
|
(93
|
)
|
|
358
|
|
||
|
|
|
|
|
|
||||
|
Net change in cash and cash equivalents
|
|
(4,087
|
)
|
|
4,292
|
|
||
|
Cash and cash equivalents at January 1,
|
|
16,564
|
|
|
39,215
|
|
||
|
Cash and cash equivalents at June 30,
|
|
$
|
12,477
|
|
|
$
|
43,507
|
|
|
|
|
|
|
|
||||
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
||||
|
Interest paid
|
|
$
|
394
|
|
|
$
|
525
|
|
|
Income taxes paid
|
|
$
|
409
|
|
|
$
|
9,605
|
|
|
•
|
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.
|
|
◦
|
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, 2018
|
|
As of December 31, 2017
|
||||||||||||||||||||
|
Fair Value Measurements:
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Marketable securities (see
Note 5
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Equity securities
|
|
$
|
10,312
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
468
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Money market funds
|
|
66,430
|
|
|
—
|
|
|
—
|
|
|
44,481
|
|
|
—
|
|
|
—
|
|
||||||
|
Corporate bonds
|
|
—
|
|
|
35,038
|
|
|
—
|
|
|
—
|
|
|
9,262
|
|
|
—
|
|
||||||
|
Government securities - U.S.
|
|
—
|
|
|
14,899
|
|
|
—
|
|
|
—
|
|
|
19,050
|
|
|
—
|
|
||||||
|
Other fixed-income securities
|
|
—
|
|
|
7,950
|
|
|
—
|
|
|
—
|
|
|
4,250
|
|
|
—
|
|
||||||
|
Total assets
|
|
$
|
76,742
|
|
|
$
|
57,887
|
|
|
$
|
—
|
|
|
$
|
44,949
|
|
|
$
|
32,562
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Related party payable (see
Note 8
)
|
|
—
|
|
|
—
|
|
|
52,177
|
|
|
—
|
|
|
—
|
|
|
98,925
|
|
||||||
|
Total liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
52,177
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
98,925
|
|
|
|
|
June 30, 2018
|
||||||||||||||
|
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Equity securities
|
|
$
|
10,498
|
|
|
$
|
35
|
|
|
$
|
(221
|
)
|
|
$
|
10,312
|
|
|
Money market funds
|
|
66,343
|
|
|
87
|
|
|
—
|
|
|
66,430
|
|
||||
|
Corporate bonds
|
|
35,271
|
|
|
7
|
|
|
(240
|
)
|
|
35,038
|
|
||||
|
Government securities - U.S.
|
|
15,027
|
|
|
5
|
|
|
(133
|
)
|
|
14,899
|
|
||||
|
Other fixed-income securities
|
|
7,970
|
|
|
4
|
|
|
(24
|
)
|
|
7,950
|
|
||||
|
Total
|
|
$
|
135,109
|
|
|
$
|
138
|
|
|
$
|
(618
|
)
|
|
$
|
134,629
|
|
|
|
|
December 31, 2017
|
||||||||||||||
|
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Equity securities
|
|
$
|
443
|
|
|
$
|
31
|
|
|
$
|
(6
|
)
|
|
$
|
468
|
|
|
Money market funds
|
|
44,525
|
|
|
—
|
|
|
(44
|
)
|
|
44,481
|
|
||||
|
Corporate bonds
|
|
9,285
|
|
|
1
|
|
|
(24
|
)
|
|
9,262
|
|
||||
|
Government securities - U.S.
|
|
19,080
|
|
|
—
|
|
|
(30
|
)
|
|
19,050
|
|
||||
|
Other fixed-income securities
|
|
4,259
|
|
|
—
|
|
|
(9
|
)
|
|
4,250
|
|
||||
|
Total
|
|
$
|
77,592
|
|
|
$
|
32
|
|
|
$
|
(113
|
)
|
|
$
|
77,511
|
|
|
|
|
Maturities
|
||||||||||||||||||
|
Marketable Debt Securities:
|
|
Less than 1 Year
|
|
1-5 Years
|
|
5-10 Years
|
|
Greater than 10 Years
|
|
Total
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Corporate bonds
|
|
$
|
20,673
|
|
|
$
|
14,365
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
35,038
|
|
|
Government securities - U.S.
|
|
—
|
|
|
13,909
|
|
|
—
|
|
|
990
|
|
|
14,899
|
|
|||||
|
Other fixed-income securities
|
|
51
|
|
|
7,899
|
|
|
—
|
|
|
—
|
|
|
7,950
|
|
|||||
|
Total
|
|
$
|
20,724
|
|
|
$
|
36,173
|
|
|
$
|
—
|
|
|
$
|
990
|
|
|
$
|
57,887
|
|
|
Inventory:
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
|
|
|
|
|
||||
|
Finished goods
|
|
$
|
4,425
|
|
|
$
|
4,774
|
|
|
Raw materials
|
|
1,299
|
|
|
1,383
|
|
||
|
Total
|
|
$
|
5,724
|
|
|
$
|
6,157
|
|
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||||||||||||||||||
|
Goodwill and Intangible Assets:
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Acquired developed technology - Noctiva
|
|
$
|
73,111
|
|
|
$
|
(4,186
|
)
|
|
$
|
68,925
|
|
|
$
|
73,111
|
|
|
$
|
(1,401
|
)
|
|
$
|
71,710
|
|
|
Acquired developed technology - Vazculep
|
|
12,061
|
|
|
(10,024
|
)
|
|
2,037
|
|
|
12,061
|
|
|
(9,616
|
)
|
|
2,445
|
|
||||||
|
Acquired product marketing rights
(1)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16,600
|
|
|
(2,132
|
)
|
|
14,468
|
|
||||||
|
Acquired developed technology
(1)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,300
|
|
|
(634
|
)
|
|
3,666
|
|
||||||
|
Total amortizable intangible assets
|
|
$
|
85,172
|
|
|
$
|
(14,210
|
)
|
|
$
|
70,962
|
|
|
$
|
106,072
|
|
|
$
|
(13,783
|
)
|
|
$
|
92,289
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
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
|
||
|
|
|
|
||
|
2018
|
|
$
|
6,619
|
|
|
2019
|
|
6,439
|
|
|
|
2020
|
|
6,439
|
|
|
|
2021
|
|
5,624
|
|
|
|
2022
|
|
5,624
|
|
|
|
|
|
|
Activity during the Six Months Ended
June 30, 2018
|
|
|
||||||||||||||||||||||
|
|
|
|
|
|
Changes in Fair Value of Related Party Payable
|
|
|
|
|
|
|
||||||||||||||||
|
Long-Term Related Party Payable:
|
Balance,
December 31, 2017
|
|
Payments to
Related Parties
|
|
Operating
Expense
|
|
Other
Expense
|
|
Warrant Exercise
|
|
Disposal
|
|
Balance,
June 30, 2018 |
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Warrants - Éclat Pharmaceuticals (a)
|
$
|
2,479
|
|
|
$
|
—
|
|
|
$
|
(312
|
)
|
|
$
|
—
|
|
|
$
|
(2,167
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Earn-out payments - Éclat Pharmaceuticals (b)
|
67,744
|
|
|
(11,113
|
)
|
|
(9,851
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46,780
|
|
|||||||
|
Royalty agreement - FSC (c)
|
5,740
|
|
|
(645
|
)
|
|
242
|
|
|
—
|
|
|
—
|
|
|
(5,337
|
)
|
|
—
|
|
|||||||
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|||||||||
|
Royalty agreement - Deerfield (d)
|
5,392
|
|
|
(1,096
|
)
|
|
—
|
|
|
(682
|
)
|
|
—
|
|
|
—
|
|
|
3,614
|
|
|||||||
|
Royalty agreement - Broadfin (e)
|
2,570
|
|
|
(522
|
)
|
|
—
|
|
|
(325
|
)
|
|
—
|
|
|
—
|
|
|
1,723
|
|
|||||||
|
Long-term liability - FSC (f)
|
15,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,000
|
)
|
|
—
|
|
|||||||
|
Total related party payable
|
98,925
|
|
|
$
|
(13,376
|
)
|
|
$
|
(9,921
|
)
|
|
$
|
(1,007
|
)
|
|
$
|
(2,167
|
)
|
|
$
|
(20,337
|
)
|
|
52,117
|
|
||
|
Less: Current portion
|
(25,007
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14,067
|
)
|
|||||||||
|
Total long-term related party payable
|
$
|
73,918
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
38,050
|
|
|||||||
|
|
|
|
Activity during the Three Months Ended June 30, 2018
|
|
|
||||||||||||||
|
|
|
|
|
|
Changes in Fair Value of Related Party Payable
|
|
|
||||||||||||
|
Long-Term Related Party Payable:
|
Balance,
March 31, 2018 |
|
Payments to
Related Parties
|
|
Operating
Expense
|
|
Other
Expense
|
|
Balance, June 30, 2018
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Earn-out payments - Éclat Pharmaceuticals (b)
|
$
|
64,983
|
|
|
$
|
(5,323
|
)
|
|
$
|
(12,880
|
)
|
|
$
|
—
|
|
|
$
|
46,780
|
|
|
Royalty agreement - FSC (c)
|
252
|
|
|
(243
|
)
|
|
(9
|
)
|
|
—
|
|
|
—
|
|
|||||
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Royalty agreement - Deerfield (d)
|
5,101
|
|
|
(537
|
)
|
|
—
|
|
|
(950
|
)
|
|
3,614
|
|
|||||
|
Royalty agreement - Broadfin (e)
|
2,431
|
|
|
(256
|
)
|
|
—
|
|
|
(452
|
)
|
|
1,723
|
|
|||||
|
Total related party payable
|
72,767
|
|
|
$
|
(6,359
|
)
|
|
$
|
(12,889
|
)
|
|
$
|
(1,402
|
)
|
|
52,117
|
|
||
|
Less: Current portion
|
(21,121
|
)
|
|
|
|
|
|
|
|
|
|
|
(14,067
|
)
|
|||||
|
Total long-term related party payable
|
$
|
51,646
|
|
|
|
|
|
|
|
|
|
|
|
$
|
38,050
|
|
|||
|
(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 was exercisable for
2,200
shares at an exercise price of
$7.44
per share, and the other warrant was exercisable for
1,100
shares at an exercise price of
$11.00
per share. On February 23, 2018, the related party exercised in full the warrant to purchase
2,200
ordinary shares. These warrants were settled by delivering to the related party cash of
$2,911
and approximately
603
ADS. On March 12, 2018, the remaining warrants to purchase
1,100
ordinary shares expired.
|
|
Assumptions for the Warrant Valuation:
|
|
December 31, 2017
|
||
|
|
|
|
||
|
Stock price
|
|
$
|
8.20
|
|
|
Weighted average exercise price per share
|
|
8.63
|
|
|
|
Expected term (years)
|
|
0.25
|
|
|
|
Expected volatility
|
|
37.90
|
%
|
|
|
Risk-free interest rate
|
|
1.39
|
%
|
|
|
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. This obligation was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See
Note
12
:
Divestiture of the Pediatric Assets
.
|
|
(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 to Deerfield. This obligation was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See
Note
12
:
Divestiture of the Pediatric Assets
.
|
|
Related Party Payable Rollforward:
|
|
Balance
|
||
|
|
|
|
||
|
Balance, December 31, 2016
|
|
$
|
169,347
|
|
|
Payments of related party payable
|
|
(19,467
|
)
|
|
|
Fair value adjustments
(1)
|
|
(22,421
|
)
|
|
|
Balance, June 30, 2017
|
|
$
|
127,459
|
|
|
|
|
|
||
|
Balance, December 31, 2017
|
|
$
|
98,925
|
|
|
Payments of related party payable
|
|
(13,376
|
)
|
|
|
Fair value adjustments
(1)
|
|
(10,928
|
)
|
|
|
Warrant exercise
|
|
(2,167
|
)
|
|
|
Disposition of the pediatrics products
|
|
(20,337
|
)
|
|
|
Balance, June 30, 2018
|
|
$
|
52,117
|
|
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
Principal amount of 4.50% exchangeable senior notes due 2023
|
|
$
|
143,750
|
|
|
$
|
—
|
|
|
Less: debt discount and issuance costs, net
|
|
30,869
|
|
|
—
|
|
||
|
Net carrying amount of liability component
|
|
112,881
|
|
|
—
|
|
||
|
Other
|
|
265
|
|
|
267
|
|
||
|
Subtotal
|
|
113,146
|
|
|
267
|
|
||
|
Less: current maturities
|
|
(108
|
)
|
|
(111
|
)
|
||
|
Long-term debt
|
|
$
|
113,038
|
|
|
$
|
156
|
|
|
|
|
|
|
|
||||
|
Equity component:
|
|
|
|
|
||||
|
Equity component of exchangeable notes, net of issuance costs
|
|
$
|
26,699
|
|
|
$
|
—
|
|
|
•
|
Prior to the close of business on the business day immediately preceding August 1, 2022, a holder of the 2018 Notes may surrender all or any portion of its 2018 Notes for exchange at any time during the
five
business day period immediately after any
five
consecutive trading day period (the “Measurement Period”) in which the trading price per $1 principal amount of 2018 Notes, as determined following a request by a holder of the 2018 Notes, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the ADSs and the exchange rate on each such trading day.
|
|
•
|
If a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs prior to the close of business on the business day immediately preceding August 1, 2022, regardless of whether a holder of the 2018 Notes has the right to require the Company to repurchase the 2018 Notes, or if Avadel is a party to a merger event that
|
|
•
|
Prior to the close of business on the business day immediately preceding August 1, 2022, a holder of the 2018 Notes may surrender all or any portion of its 2018 Notes for exchange at any time during any calendar quarter commencing after the calendar quarter ending on June 30, 2018 (and only during such calendar quarter), if the last reported sale price of the ADSs for at least
20
trading days (whether or not consecutive) during the period of
30
consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to
130%
of the exchange price on each applicable trading day.
|
|
•
|
If the Company calls the 2018 Notes for redemption pursuant to Article 16 prior to the close of business on the business day immediately preceding August 1, 2022, then a holder of the 2018 Notes may surrender all or any portion of its 2018 Notes for exchange at any time prior to the close of business on the second business day prior to the redemption date, even if the 2018 Notes are not otherwise exchangeable at such time. After that time, the right to exchange shall expire, unless the Company defaults in the payment of the redemption price, in which case a holder of the 2018 Notes may exchange its 2018 Notes until the redemption price has been paid or duly provided for.
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Income (Loss) Before Income Taxes:
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Ireland
|
|
$
|
(10,962
|
)
|
|
$
|
2,684
|
|
|
$
|
(15,889
|
)
|
|
$
|
9,348
|
|
|
United States
|
|
7,019
|
|
|
34,651
|
|
|
(2,816
|
)
|
|
66,661
|
|
||||
|
France
|
|
163
|
|
|
(1,038
|
)
|
|
362
|
|
|
(5,263
|
)
|
||||
|
Total income (loss) before income taxes
|
|
$
|
(3,780
|
)
|
|
$
|
36,297
|
|
|
$
|
(18,343
|
)
|
|
$
|
70,746
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Income Tax Rate Reconciliation:
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Statutory tax rate
|
|
12.5
|
%
|
|
12.5
|
%
|
|
12.5
|
%
|
|
12.5
|
%
|
||||
|
International tax rates differential
|
|
(1.5
|
)%
|
|
20.4
|
%
|
|
6.8
|
%
|
|
18.7
|
%
|
||||
|
Change in valuation allowance
|
|
(39.4
|
)%
|
|
0.6
|
%
|
|
(11.9
|
)%
|
|
1.3
|
%
|
||||
|
Change in fair value of nondeductible contingent consideration
|
|
67.6
|
%
|
|
(13.1
|
)%
|
|
10.9
|
%
|
|
(10.2
|
)%
|
||||
|
Nondeductible stock-based compensation
|
|
(4.7
|
)%
|
|
—
|
%
|
|
(1.8
|
)%
|
|
—
|
%
|
||||
|
Unrecognized tax benefits
|
|
(7.6
|
)%
|
|
—
|
%
|
|
(2.8
|
)%
|
|
—
|
%
|
||||
|
State and local income taxes, net of federal
|
|
1.0
|
%
|
|
—
|
%
|
|
0.3
|
%
|
|
—
|
%
|
||||
|
Change in U.S. tax law
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
||||
|
Other
|
|
(18.9
|
)%
|
|
(0.1
|
)%
|
|
0.6
|
%
|
|
0.2
|
%
|
||||
|
Effective income tax rate
|
|
9.0
|
%
|
|
20.3
|
%
|
|
14.6
|
%
|
|
22.5
|
%
|
||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Income tax (benefit) provision - at statutory tax rate
|
|
$
|
(473
|
)
|
|
$
|
4,537
|
|
|
$
|
(2,293
|
)
|
|
$
|
8,843
|
|
|
International tax rates differential
|
|
57
|
|
|
7,399
|
|
|
(1,241
|
)
|
|
13,259
|
|
||||
|
Change in valuation allowance
|
|
1,491
|
|
|
230
|
|
|
2,181
|
|
|
914
|
|
||||
|
Change in fair value of nondeductible contingent consideration
|
|
(2,556
|
)
|
|
(4,757
|
)
|
|
(2,005
|
)
|
|
(7,232
|
)
|
||||
|
Nondeductible stock-based compensation
|
|
176
|
|
|
—
|
|
|
336
|
|
|
—
|
|
||||
|
Unrecognized tax benefits
|
|
288
|
|
|
—
|
|
|
508
|
|
|
—
|
|
||||
|
State and local income taxes, net of federal
|
|
(38
|
)
|
|
—
|
|
|
(57
|
)
|
|
—
|
|
||||
|
Change in U.S. tax law
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
Other
|
|
713
|
|
|
(39
|
)
|
|
(98
|
)
|
|
125
|
|
||||
|
Income tax (benefit) provision - at effective income tax rate
|
|
$
|
(342
|
)
|
|
$
|
7,370
|
|
|
$
|
(2,669
|
)
|
|
$
|
15,909
|
|
|
Prepaid Expenses and Other Current Assets:
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
|
|
|
|
|
||||
|
Valued-added tax recoverable
|
|
$
|
888
|
|
|
$
|
1,206
|
|
|
Prepaid and other expenses
|
|
4,837
|
|
|
7,106
|
|
||
|
Guarantee from Armistice (see
Note 12
)
|
|
489
|
|
|
—
|
|
||
|
Income tax receivable
|
|
868
|
|
|
518
|
|
||
|
Other
|
|
124
|
|
|
128
|
|
||
|
Total
|
|
$
|
7,206
|
|
|
$
|
8,958
|
|
|
Other Non-Current Assets:
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
|
|
|
|
|
||||
|
Deferred tax assets
|
|
$
|
6,464
|
|
|
$
|
3,877
|
|
|
Long-term deposits
|
|
4,827
|
|
|
3,350
|
|
||
|
Guarantee from Armistice (see
Note 12
)
|
|
5,964
|
|
|
—
|
|
||
|
Right of use assets at contract manufacturing organizations
|
|
4,876
|
|
|
2,909
|
|
||
|
Other
|
|
113
|
|
|
113
|
|
||
|
Total
|
|
$
|
22,244
|
|
|
$
|
10,249
|
|
|
Accrued Expenses
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
|
|
|
|
|
||||
|
Accrued compensation
|
|
$
|
3,115
|
|
|
$
|
3,157
|
|
|
Accrued social charges
|
|
923
|
|
|
1,204
|
|
||
|
Accrued employee severance (see
Note 13
)
|
|
633
|
|
|
1,000
|
|
||
|
Customer allowances
|
|
7,813
|
|
|
10,613
|
|
||
|
Accrued Exclusive License and Assignment Agreement (ELAA) payment
|
|
—
|
|
|
20,000
|
|
||
|
Accrued contract manufacturing organization charges
|
|
1,076
|
|
|
2,327
|
|
||
|
Accrued contract sales organization and marketing costs
|
|
3,999
|
|
|
7,641
|
|
||
|
Other
|
|
3,934
|
|
|
4,984
|
|
||
|
Total
|
|
$
|
21,493
|
|
|
$
|
50,926
|
|
|
Other Non-Current Liabilities:
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
|
|
|
|
|
||||
|
Provision for retirement indemnity
|
|
$
|
1,271
|
|
|
$
|
1,303
|
|
|
Customer allowances
|
|
1,764
|
|
|
1,636
|
|
||
|
Unrecognized tax benefits
|
|
4,229
|
|
|
3,954
|
|
||
|
Guarantee to Deerfield (see
Note 12
)
|
|
5,985
|
|
|
—
|
|
||
|
Other
|
|
740
|
|
|
191
|
|
||
|
Total
|
|
$
|
13,989
|
|
|
$
|
7,084
|
|
|
•
|
Avadel Ireland will provide Cerecor with four product formulations utilizing Avadel Ireland’s LiquiTime™ technology, and will complete pilot bioequivalence studies for such product formulations within 18 months;
|
|
•
|
Cerecor will reimburse Avadel Ireland for development costs of the four LiquiTime™ products in excess of
$1,000
in the aggregate;
|
|
•
|
Upon transfer of the four product formulations, Cerecor will assume all remaining development costs and responsibilities for the product development, clinical studies, NDA applications and associated filing fees; and
|
|
•
|
Upon regulatory approval and commercial launch of any LiquiTime™ products, Cerecor will pay Avadel Ireland quarterly royalties based on a percentage of net sales of any such products in the mid-single digit range.
|
|
Severance Obligation:
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
Balance of restructuring accrual at January 1,
|
|
$
|
1,000
|
|
|
$
|
—
|
|
|
Charges for employee severance, benefits and other
|
|
203
|
|
|
3,722
|
|
||
|
Payments
|
|
(515
|
)
|
|
—
|
|
||
|
Foreign currency impact
|
|
(55
|
)
|
|
200
|
|
||
|
Balance of restructuring accrual at June 30,
|
|
$
|
633
|
|
|
$
|
3,922
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Net (Loss) Income Per Share:
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net (loss) income
|
|
$
|
(3,438
|
)
|
|
$
|
28,927
|
|
|
$
|
(15,674
|
)
|
|
$
|
54,837
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic shares
|
|
36,772
|
|
|
41,091
|
|
|
37,666
|
|
|
41,233
|
|
||||
|
Effect of dilutive securities—options, RSU’s and warrants outstanding
|
|
—
|
|
|
1,396
|
|
|
—
|
|
|
1,392
|
|
||||
|
Diluted shares
|
|
36,772
|
|
|
42,487
|
|
|
37,666
|
|
|
42,625
|
|
||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net (loss) income per share - basic
|
|
$
|
(0.09
|
)
|
|
$
|
0.70
|
|
|
$
|
(0.42
|
)
|
|
$
|
1.33
|
|
|
Net (loss) income per share - diluted
|
|
$
|
(0.09
|
)
|
|
$
|
0.68
|
|
|
$
|
(0.42
|
)
|
|
$
|
1.29
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Accumulated Other Comprehensive Income (Loss):
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency translation adjustment:
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Beginning balance
|
|
$
|
(22,953
|
)
|
|
$
|
(23,206
|
)
|
|
$
|
(23,202
|
)
|
|
$
|
(23,336
|
)
|
|
Net other comprehensive income
|
|
(482
|
)
|
|
117
|
|
|
(233
|
)
|
|
247
|
|
||||
|
Balance at June 30,
|
|
$
|
(23,435
|
)
|
|
$
|
(23,089
|
)
|
|
$
|
(23,435
|
)
|
|
$
|
(23,089
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Unrealized gain (loss) on marketable securities, net
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Beginning balance
|
|
$
|
(302
|
)
|
|
$
|
(185
|
)
|
|
$
|
(64
|
)
|
|
$
|
(229
|
)
|
|
Net other comprehensive income, net of ($11), ($26), ($70) and ($92) tax, respectively
|
|
78
|
|
|
594
|
|
|
(160
|
)
|
|
638
|
|
||||
|
Balance at June 30,
|
|
$
|
(224
|
)
|
|
$
|
409
|
|
|
$
|
(224
|
)
|
|
$
|
409
|
|
|
Accumulated other comprehensive loss at June 30,
|
|
$
|
(23,659
|
)
|
|
$
|
(22,680
|
)
|
|
$
|
(23,659
|
)
|
|
$
|
(22,680
|
)
|
|
Shareholders’ Equity:
|
|
2018
|
||
|
|
|
|
||
|
Shareholders’ equity - January 1,
|
|
$
|
85,580
|
|
|
Net loss
|
|
(15,674
|
)
|
|
|
Other comprehensive income
|
|
(393
|
)
|
|
|
Exercise of stock options
|
|
535
|
|
|
|
Stock-based compensation expense
|
|
4,358
|
|
|
|
Share repurchases
|
|
(27,637
|
)
|
|
|
Exercise of warrants (see
Note 8
)
|
|
2,911
|
|
|
|
Expiration of warrants (see
Note 8
)
|
|
2,167
|
|
|
|
Equity component of 2018 Notes (see
Note 9)
|
|
26,699
|
|
|
|
Shareholders’ equity - June 30,
|
|
$
|
78,546
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
Revenues by Product:
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
Bloxiverz
|
|
$
|
5,544
|
|
|
$
|
13,719
|
|
|
$
|
13,035
|
|
|
$
|
27,621
|
|
|
Vazculep
|
|
11,377
|
|
|
10,154
|
|
|
24,338
|
|
|
20,334
|
|
||||
|
Akovaz
|
|
11,875
|
|
|
20,912
|
|
|
22,092
|
|
|
46,549
|
|
||||
|
Noctiva
|
|
289
|
|
|
—
|
|
|
955
|
|
|
—
|
|
||||
|
Other
|
|
31
|
|
|
2,320
|
|
|
1,857
|
|
|
4,358
|
|
||||
|
Total product sales
|
|
29,116
|
|
|
47,105
|
|
|
62,277
|
|
|
98,862
|
|
||||
|
License revenue
|
|
114
|
|
|
(794
|
)
|
|
246
|
|
|
(44
|
)
|
||||
|
Total revenues
|
|
$
|
29,230
|
|
|
$
|
46,311
|
|
|
$
|
62,523
|
|
|
$
|
98,818
|
|
|
Purchase Commitment
|
|
Balance
|
||
|
|
|
|
||
|
2018
|
|
$
|
660
|
|
|
2019
|
|
1,082
|
|
|
|
2020
|
|
1,320
|
|
|
|
2021
|
|
1,320
|
|
|
|
2022
|
|
1,320
|
|
|
|
Thereafter
|
|
220
|
|
|
|
Total
|
|
$
|
5,922
|
|
|
•
|
Being first-to-file New Drug Applications (“NDAs”) for established products that are being marketed in the United States without approval from the U.S. Food and Drug Administration (“FDA”). We strive to seek FDA approval through the FDA’s 505 B-2 regulatory pathway. We refer to these products as Unapproved Marketed Drugs (“UMDs”)
|
|
•
|
In-licensing and acquiring commercial-stage products in our therapeutic areas of focus
|
|
•
|
Developing products that use our Micropump®- or Liquitime®- based drug delivery technologies
|
|
•
|
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.
|
|
◦
|
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.
|
|
•
|
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 Large 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 process of raising capital and associated cost of such capital for a company of our financial profile can be difficult and potentially expensive. If the need were to arise to raise additional capital, access to that capital may be difficult and/or expensive and, as a result, could create liquidity challenges for the Company.
|
|
•
|
Revenue was
$29,230
and
$62,523
for the three and
six
months ended
June 30, 2018
, compared to
$46,311
and
$98,818
in the same period last year, respectively. This year over year decrease was primarily the result of competition as noted above in our discussion of
Key Business Trends and Highlights
.
We experienced declines in unit volumes across all our UMD products due to additional competition.
|
|
•
|
Operating loss was
$2,785
and
$15,410
for the three and
six
months ended
June 30, 2018
, compared to operating income of
$34,126
and
$67,467
for the same period last year, respectively. The decrease in operating income for the three months ended June 30, 2018 was largely driven by the lower gross margin (sales minus cost of goods sold) of
$16,032
and higher selling, general and administrative (SG&A) expenses of
$15,414
driven primarily by the 2018 launch of Noctiva. The
|
|
•
|
Net loss was
$3,438
and
$15,674
for the three and
six
months ended
June 30, 2018
, respectively, compared to net income of
$28,927
and
$54,837
in the same period last year, respectively.
|
|
•
|
Diluted net loss per share was
$(0.09)
and
$(0.42)
for the three and
six
months ended
June 30, 2018
, compared to diluted net income per share of
$0.68
and
$1.29
in the same period last year, respectively.
|
|
•
|
Cash and marketable securities increased
$53,031
to
$147,106
at
June 30, 2018
, from
$94,075
at
December 31, 2017
. This increase was largely driven from
$137,560
in net proceeds from the February 2018 issuance of our 2018 Notes, offset by
$37,942
use of cash in operations,
$27,637
in share buybacks and a
$20,000
milestone payment paid to Serenity Pharmaceuticals, LLC associated with the ELAA.
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Comparative Statements of Income (Loss)
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Product sales
|
|
$
|
29,116
|
|
|
$
|
47,105
|
|
|
$
|
(17,989
|
)
|
|
(38.2
|
)%
|
|
License revenue
|
|
114
|
|
|
(794
|
)
|
|
908
|
|
|
114.4
|
%
|
|||
|
Total revenues
|
|
29,230
|
|
|
46,311
|
|
|
(17,081
|
)
|
|
(36.9
|
)%
|
|||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
Cost of products
|
|
3,512
|
|
|
4,561
|
|
|
(1,049
|
)
|
|
(23.0
|
)%
|
|||
|
Research and development expenses
|
|
11,890
|
|
|
6,792
|
|
|
5,098
|
|
|
75.1
|
%
|
|||
|
Selling, general and administrative expenses
|
|
27,843
|
|
|
12,429
|
|
|
15,414
|
|
|
124.0
|
%
|
|||
|
Intangible asset amortization
|
|
1,609
|
|
|
564
|
|
|
1,045
|
|
|
185.3
|
%
|
|||
|
Gain - changes in fair value of related party contingent consideration
|
|
(12,889
|
)
|
|
(13,230
|
)
|
|
341
|
|
|
2.6
|
%
|
|||
|
Restructuring costs
|
|
50
|
|
|
1,069
|
|
|
(1,019
|
)
|
|
(95.3
|
)%
|
|||
|
Total operating expenses
|
|
32,015
|
|
|
12,185
|
|
|
19,830
|
|
|
162.7
|
%
|
|||
|
Operating (loss) income
|
|
(2,785
|
)
|
|
34,126
|
|
|
(36,911
|
)
|
|
(108.2
|
)%
|
|||
|
Investment and other income (expense), net
|
|
583
|
|
|
764
|
|
|
(181
|
)
|
|
(23.7
|
)%
|
|||
|
Interest expense, net
|
|
(2,980
|
)
|
|
(263
|
)
|
|
(2,717
|
)
|
|
(1,033.1
|
)%
|
|||
|
Other income - changes in fair value of related party payable
|
|
1,402
|
|
|
1,670
|
|
|
(268
|
)
|
|
(16.0
|
)%
|
|||
|
(Loss) income before income taxes
|
|
(3,780
|
)
|
|
36,297
|
|
|
(40,077
|
)
|
|
(110.4
|
)%
|
|||
|
Income tax (benefit) provision
|
|
(342
|
)
|
|
7,370
|
|
|
(7,712
|
)
|
|
(104.6
|
)%
|
|||
|
Net (loss) income
|
|
$
|
(3,438
|
)
|
|
$
|
28,927
|
|
|
$
|
(32,365
|
)
|
|
(111.9
|
)%
|
|
Net (loss) income per share - diluted
|
|
$
|
(0.09
|
)
|
|
$
|
0.68
|
|
|
$
|
(0.77
|
)
|
|
(113.2
|
)%
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Comparative Statements of Income (Loss)
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Product sales
|
|
$
|
62,277
|
|
|
$
|
98,862
|
|
|
$
|
(36,585
|
)
|
|
(37.0
|
)%
|
|
License revenue
|
|
246
|
|
|
(44
|
)
|
|
290
|
|
|
659.1
|
%
|
|||
|
Total revenues
|
|
62,523
|
|
|
98,818
|
|
|
(36,295
|
)
|
|
(36.7
|
)%
|
|||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Cost of products
|
|
10,104
|
|
|
8,463
|
|
|
1,641
|
|
|
19.4
|
%
|
|||
|
Research and development expenses
|
|
21,841
|
|
|
13,998
|
|
|
7,843
|
|
|
56.0
|
%
|
|||
|
Selling, general and administrative expenses
|
|
52,330
|
|
|
24,241
|
|
|
28,089
|
|
|
115.9
|
%
|
|||
|
Intangible asset amortization
|
|
3,376
|
|
|
1,128
|
|
|
2,248
|
|
|
199.3
|
%
|
|||
|
Loss (gain) - changes in fair value of related party contingent consideration
|
|
(9,921
|
)
|
|
(20,201
|
)
|
|
10,280
|
|
|
50.9
|
%
|
|||
|
Restructuring costs
|
|
203
|
|
|
3,722
|
|
|
(3,519
|
)
|
|
(94.5
|
)%
|
|||
|
Total operating expenses
|
|
77,933
|
|
|
31,351
|
|
|
46,582
|
|
|
148.6
|
%
|
|||
|
Operating (loss) income
|
|
(15,410
|
)
|
|
67,467
|
|
|
(82,877
|
)
|
|
(122.8
|
)%
|
|||
|
Investment income and other income (expense), net
|
|
637
|
|
|
1,585
|
|
|
(948
|
)
|
|
(59.8
|
)%
|
|||
|
Interest expense, net
|
|
(4,577
|
)
|
|
(526
|
)
|
|
(4,051
|
)
|
|
(770.2
|
)%
|
|||
|
Other income - changes in fair value of related party payable
|
|
1,007
|
|
|
2,220
|
|
|
(1,213
|
)
|
|
(54.6
|
)%
|
|||
|
(Loss) income before income taxes
|
|
(18,343
|
)
|
|
70,746
|
|
|
(89,089
|
)
|
|
(125.9
|
)%
|
|||
|
Income tax (benefit) provision
|
|
(2,669
|
)
|
|
15,909
|
|
|
(18,578
|
)
|
|
(116.8
|
)%
|
|||
|
Net (loss) income
|
|
$
|
(15,674
|
)
|
|
$
|
54,837
|
|
|
$
|
(70,511
|
)
|
|
(128.6
|
)%
|
|
Net (loss) income per share - diluted
|
|
$
|
(0.42
|
)
|
|
$
|
1.29
|
|
|
$
|
(1.71
|
)
|
|
(132.6
|
)%
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Revenues:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Bloxiverz
|
|
$
|
5,544
|
|
|
$
|
13,719
|
|
|
$
|
(8,175
|
)
|
|
(59.6
|
)%
|
|
Vazculep
|
|
11,377
|
|
|
10,154
|
|
|
1,223
|
|
|
12.0
|
%
|
|||
|
Akovaz
|
|
11,875
|
|
|
20,912
|
|
|
(9,037
|
)
|
|
(43.2
|
)%
|
|||
|
Noctiva
|
|
289
|
|
|
—
|
|
|
289
|
|
|
n/a
|
|
|||
|
Other
|
|
31
|
|
|
2,320
|
|
|
(2,289
|
)
|
|
(98.7
|
)%
|
|||
|
Product sales
|
|
29,116
|
|
|
47,105
|
|
|
(17,989
|
)
|
|
(38.2
|
)%
|
|||
|
License revenue
|
|
114
|
|
|
(794
|
)
|
|
908
|
|
|
114.4
|
%
|
|||
|
Total revenues
|
|
$
|
29,230
|
|
|
$
|
46,311
|
|
|
$
|
(17,081
|
)
|
|
(36.9
|
)%
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Revenues:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Bloxiverz
|
|
$
|
13,035
|
|
|
$
|
27,621
|
|
|
$
|
(14,586
|
)
|
|
(52.8
|
)%
|
|
Vazculep
|
|
24,338
|
|
|
20,334
|
|
|
4,004
|
|
|
19.7
|
%
|
|||
|
Akovaz
|
|
22,092
|
|
|
46,549
|
|
|
(24,457
|
)
|
|
(52.5
|
)%
|
|||
|
Noctiva
|
|
955
|
|
|
—
|
|
|
955
|
|
|
n/a
|
|
|||
|
Other
|
|
1,857
|
|
|
4,358
|
|
|
(2,501
|
)
|
|
(57.4
|
)%
|
|||
|
Product sales
|
|
62,277
|
|
|
98,862
|
|
|
(36,585
|
)
|
|
(37.0
|
)%
|
|||
|
License revenue
|
|
246
|
|
|
(44
|
)
|
|
290
|
|
|
659.1
|
%
|
|||
|
Total revenues
|
|
$
|
62,523
|
|
|
$
|
98,818
|
|
|
$
|
(36,295
|
)
|
|
(36.7
|
)%
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Cost of Products:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Cost of products
|
|
$
|
3,512
|
|
|
$
|
4,561
|
|
|
$
|
(1,049
|
)
|
|
(23.0
|
)%
|
|
Percentage of total revenues
|
|
12.0
|
%
|
|
9.8
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Cost of Products:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Cost of products
|
|
$
|
10,104
|
|
|
$
|
8,463
|
|
|
$
|
1,641
|
|
|
19.4
|
%
|
|
Percentage of total revenues
|
|
16.2
|
%
|
|
8.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Research and Development Expenses:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Research and development expenses
|
|
$
|
11,890
|
|
|
$
|
6,792
|
|
|
$
|
5,098
|
|
|
75.1
|
%
|
|
Percentage of total revenues
|
|
40.7
|
%
|
|
14.7
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Research and Development Expenses:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Research and development expenses
|
|
$
|
21,841
|
|
|
$
|
13,998
|
|
|
$
|
7,843
|
|
|
56.0
|
%
|
|
Percentage of total revenues
|
|
34.9
|
%
|
|
14.2
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Selling, General and Administrative Expenses:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Selling, general and administrative expenses
|
|
$
|
27,843
|
|
|
$
|
12,429
|
|
|
$
|
15,414
|
|
|
124.0
|
%
|
|
Percentage of total revenues
|
|
95.3
|
%
|
|
26.8
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Selling, General and Administrative Expenses:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Selling, general and administrative expenses
|
|
$
|
52,330
|
|
|
$
|
24,241
|
|
|
$
|
28,089
|
|
|
115.9
|
%
|
|
Percentage of total revenues
|
|
83.7
|
%
|
|
24.5
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Intangibles Asset Amortization:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Intangible asset amortization
|
|
$
|
1,609
|
|
|
$
|
564
|
|
|
$
|
1,045
|
|
|
185.3
|
%
|
|
Percentage of total revenues
|
|
5.5
|
%
|
|
1.2
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Intangibles Asset Amortization:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Intangible asset amortization
|
|
$
|
3,376
|
|
|
$
|
1,128
|
|
|
$
|
2,248
|
|
|
199.3
|
%
|
|
Percentage of total revenues
|
|
5.4
|
%
|
|
1.1
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Gain - Changes in Fair Value of Related Party Contingent Consideration:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Gain - changes in fair value of related party contingent consideration
|
|
$
|
(12,889
|
)
|
|
$
|
(13,230
|
)
|
|
$
|
341
|
|
|
2.6
|
%
|
|
Percentage of total revenues
|
|
(44.1
|
)%
|
|
(28.6
|
)%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Gain - Changes in Fair Value of Related Party Contingent Consideration:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Gain - changes in fair value of related party contingent consideration
|
|
$
|
(9,921
|
)
|
|
$
|
(20,201
|
)
|
|
$
|
10,280
|
|
|
50.9
|
%
|
|
Percentage of total revenues
|
|
(15.9
|
)%
|
|
(20.4
|
)%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Restructuring Costs
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Restructuring costs
|
|
$
|
50
|
|
|
$
|
1,069
|
|
|
$
|
(1,019
|
)
|
|
(95.3
|
)%
|
|
Percentage of total revenues
|
|
0.2
|
%
|
|
2.3
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Restructuring Costs
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Restructuring costs
|
|
$
|
203
|
|
|
$
|
3,722
|
|
|
$
|
(3,519
|
)
|
|
(94.5
|
)%
|
|
Percentage of total revenues
|
|
0.3
|
%
|
|
3.8
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Investment Income and Other Income (Expense), net
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Investment income and other income (expense), net
|
|
$
|
583
|
|
|
$
|
764
|
|
|
$
|
(181
|
)
|
|
(23.7
|
)%
|
|
Percentage of total revenues
|
|
2.0
|
%
|
|
1.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Investment Income and Other Income (Expense), net
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Investment income and other income (expense), net
|
|
$
|
637
|
|
|
$
|
1,585
|
|
|
$
|
(948
|
)
|
|
(59.8
|
)%
|
|
Percentage of total revenues
|
|
1.0
|
%
|
|
1.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Interest Expense, net
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Interest expense, net
|
|
$
|
2,980
|
|
|
$
|
263
|
|
|
$
|
2,717
|
|
|
1,033.1
|
%
|
|
Percentage of total revenues
|
|
10.2
|
%
|
|
0.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Interest Expense, net
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Interest expense, net
|
|
$
|
4,577
|
|
|
$
|
526
|
|
|
$
|
4,051
|
|
|
770.2
|
%
|
|
Percentage of total revenues
|
|
7.3
|
%
|
|
0.5
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Other Income - Changes in Fair Value of Related Party Payable
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Other income - changes in fair value of related party payable
|
|
$
|
1,402
|
|
|
$
|
1,670
|
|
|
$
|
(268
|
)
|
|
(16.0
|
)%
|
|
Percentage of total revenues
|
|
4.8
|
%
|
|
3.6
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Other Income - Changes in Fair Value of Related Party Payable
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Other income - changes in fair value of related party payable
|
|
$
|
1,007
|
|
|
$
|
2,220
|
|
|
$
|
(1,213
|
)
|
|
(54.6
|
)%
|
|
Percentage of total revenues
|
|
1.6
|
%
|
|
2.2
|
%
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Income Tax (Benefit) Provision:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Income tax (benefit) provision
|
|
$
|
(342
|
)
|
|
$
|
7,370
|
|
|
$
|
(7,712
|
)
|
|
(104.6
|
)%
|
|
Percentage of income (loss) before income taxes
|
|
(9.0
|
)%
|
|
(20.3
|
)%
|
|
|
|
|
|
|
|||
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
Statutory tax rate
|
|
12.5
|
%
|
|
12.5
|
%
|
||
|
International tax rates differential
|
|
(1.5
|
)%
|
|
20.4
|
%
|
||
|
Change in valuation allowance
|
|
(39.4
|
)%
|
|
0.6
|
%
|
||
|
Change in fair value of nondeductible contingent consideration
|
|
67.6
|
%
|
|
(13.1
|
)%
|
||
|
Nondeductible stock-based compensation
|
|
(4.7
|
)%
|
|
—
|
%
|
||
|
Unrecognized tax benefits
|
|
(7.6
|
)%
|
|
—
|
%
|
||
|
State and local income taxes, net of federal
|
|
1.0
|
%
|
|
—
|
%
|
||
|
Change in U.S. tax law
|
|
—
|
%
|
|
—
|
%
|
||
|
Other
|
|
(18.9
|
)%
|
|
(0.1
|
)%
|
||
|
Effective income tax rate
|
|
9.0
|
%
|
|
20.3
|
%
|
||
|
|
|
|
|
|
||||
|
Income tax (benefit) provision - at statutory tax rate
|
|
$
|
(473
|
)
|
|
$
|
4,537
|
|
|
International tax rates differential
|
|
57
|
|
|
7,399
|
|
||
|
Change in valuation allowance
|
|
1,491
|
|
|
230
|
|
||
|
Change in fair value of nondeductible contingent consideration
|
|
(2,556
|
)
|
|
(4,757
|
)
|
||
|
Nondeductible stock-based compensation
|
|
176
|
|
|
—
|
|
||
|
Unrecognized tax benefits
|
|
288
|
|
|
—
|
|
||
|
State and local income taxes, net of federal
|
|
(38
|
)
|
|
—
|
|
||
|
Change in U.S. tax law
|
|
—
|
|
|
—
|
|
||
|
Other
|
|
713
|
|
|
(39
|
)
|
||
|
Income tax (benefit) provision - at effective income tax rate
|
|
$
|
(342
|
)
|
|
$
|
7,370
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Income Tax (Benefit) Provision:
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Income tax (benefit) provision
|
|
$
|
(2,669
|
)
|
|
$
|
15,909
|
|
|
$
|
(18,578
|
)
|
|
(116.8
|
)%
|
|
Percentage of income (loss) before income taxes
|
|
(14.6
|
)%
|
|
(22.5
|
)%
|
|
|
|
|
|
|
|||
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
Statutory tax rate
|
|
12.5
|
%
|
|
12.5
|
%
|
||
|
International tax rates differential
|
|
6.8
|
%
|
|
18.7
|
%
|
||
|
Change in valuation allowance
|
|
(11.9
|
)%
|
|
1.3
|
%
|
||
|
Nondeductible change in fair value of contingent consideration
|
|
10.9
|
%
|
|
(10.2
|
)%
|
||
|
Nondeductible stock-based compensation
|
|
(1.8
|
)%
|
|
—
|
%
|
||
|
Unrecognized tax benefits
|
|
(2.8
|
)%
|
|
—
|
%
|
||
|
State and local income taxes, net of federal
|
|
0.3
|
%
|
|
—
|
%
|
||
|
Change in U.S. tax law
|
|
—
|
%
|
|
—
|
%
|
||
|
Other
|
|
0.6
|
%
|
|
0.2
|
%
|
||
|
Effective income tax rate
|
|
14.6
|
%
|
|
22.5
|
%
|
||
|
|
|
|
|
|
||||
|
Income tax (benefit) provision - at statutory tax rate
|
|
$
|
(2,293
|
)
|
|
$
|
8,843
|
|
|
International tax rates differential
|
|
(1,241
|
)
|
|
13,259
|
|
||
|
Change in valuation allowance
|
|
2,181
|
|
|
914
|
|
||
|
Nondeductible change in fair value of contingent consideration
|
|
(2,005
|
)
|
|
(7,232
|
)
|
||
|
Nondeductible stock-based compensation
|
|
336
|
|
|
—
|
|
||
|
Unrecognized tax benefits
|
|
508
|
|
|
—
|
|
||
|
State and local income taxes, net of federal
|
|
(57
|
)
|
|
—
|
|
||
|
Change in U.S. tax law
|
|
—
|
|
|
—
|
|
||
|
Other
|
|
(98
|
)
|
|
125
|
|
||
|
Income tax (benefit) provision - at effective income tax rate
|
|
$
|
(2,669
|
)
|
|
$
|
15,909
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
|
2018 vs. 2017
|
||||||||||||
|
Net cash provided by (used in):
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Operating activities
|
|
$
|
(37,942
|
)
|
|
$
|
33,536
|
|
|
$
|
(71,478
|
)
|
|
(213.1
|
)%
|
|
Investing activities
|
|
(79,212
|
)
|
|
(16,244
|
)
|
|
(62,968
|
)
|
|
(387.6
|
)%
|
|||
|
Financing activities
|
|
113,160
|
|
|
(13,358
|
)
|
|
126,518
|
|
|
947.1
|
%
|
|||
|
Purchase Commitment
|
|
Balance
|
||
|
|
|
|
||
|
2018
|
|
$
|
660
|
|
|
2019
|
|
1,082
|
|
|
|
2020
|
|
1,320
|
|
|
|
2021
|
|
1,320
|
|
|
|
2022
|
|
1,320
|
|
|
|
Thereafter
|
|
220
|
|
|
|
Total
|
|
$
|
5,922
|
|
|
ITEM 1.
|
LEGAL PROCEEDINGS.
|
|
Issuer Purchases of Equity Securities
|
||||||||||||||
|
Second Quarter 2018
|
||||||||||||||
|
(in thousands, except per share data)
|
||||||||||||||
|
Period
|
|
Total Number of Shares Purchased
|
|
Average Price Paid Per Share
|
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs
|
||||||
|
April 1 - April 30, 2018
|
|
984
|
|
|
$
|
7.55
|
|
|
984
|
|
|
$
|
—
|
|
|
May 1 - May 31, 2018
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||
|
June 1 - June 30, 2018
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||
|
Total
|
|
984
|
|
|
$
|
7.55
|
|
|
984
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
31.1*
|
|
|
|
31.2*
|
|
|
|
32.1**
|
|
|
|
32.2**
|
|
|
|
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 7, 2018
|
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 |
|---|