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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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for the quarterly period ended June 30, 2018
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OR
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
(State of incorporation)
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45-0705648
(I.R.S. Employer Identification No.)
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400 E. Pratt Street, Suite 606
Baltimore, Maryland 21202
(Address of principal executive offices)
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(410) 522‑8707
(Registrant’s telephone number,
including area code)
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Large accelerated filer
¨
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Accelerated filer
¨
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Non-accelerated filer
¨
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(Do not check if a smaller reporting company)
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Smaller reporting company
þ
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Emerging growth company
þ
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June 30, 2018
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December 31, 2017
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(unaudited)
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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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2,179,775
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$
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2,472,187
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Accounts receivable, net
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3,308,324
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2,935,025
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Other receivables
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88,020
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427,241
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Escrowed cash receivable
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3,757,677
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3,752,390
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Inventory, net
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1,540,534
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382,153
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Prepaid expenses and other current assets
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954,454
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703,225
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Restricted cash-current portion
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9,527
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1,959
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Total current assets
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11,838,311
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10,674,180
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Property and equipment, net
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58,417
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44,612
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Intangibles assets, net
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32,003,161
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17,664,480
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Goodwill
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18,070,283
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14,292,282
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Restricted cash, net of current portion
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175,042
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131,353
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Total assets
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$
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62,145,214
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$
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42,806,907
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Liabilities and stockholders’ equity
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Current liabilities:
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Accounts payable
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$
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2,939,939
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$
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1,298,980
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Accrued expenses and other current liabilities
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10,334,695
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7,531,122
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Income taxes payable
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2,171,048
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2,259,148
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Long-term debt- current portion
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1,050,000
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—
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Contingent consideration-current portion
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2,549,638
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—
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Total current liabilities
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19,045,320
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11,089,250
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Long term debt, net of current portion
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14,376,566
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—
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Contingent consideration, net of current portion
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8,223,003
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2,576,633
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Deferred tax liability, net
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30,908
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7,144
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License obligations
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1,250,000
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1,250,000
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Other long-term liabilities
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—
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24,272
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Total liabilities
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42,925,797
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14,947,299
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Stockholders’ equity:
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Preferred stock—$0.001 par value; 5,000,000 shares authorized at June 30, 2018 and December 31, 2017; zero shares issued and outstanding at June 30, 2018 and December 31, 2017
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—
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—
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Common stock—$0.001 par value; 200,000,000 shares authorized at June 30, 2018 and December 31, 2017; 33,790,686 and 31,266,989 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively
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33,792
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31,268
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Additional paid-in capital
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87,241,204
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83,338,136
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Contingently issuable shares
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—
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2,655,464
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Accumulated deficit
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(68,055,579
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)
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(58,165,260
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)
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Total stockholders’ equity
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19,219,417
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27,859,608
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Total liabilities and stockholders’ equity
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$
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62,145,214
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$
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42,806,907
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Three Months Ended
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Six Months Ended
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June 30,
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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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Revenues
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Product revenue, net
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$
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4,710,919
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$
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—
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$
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8,971,038
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$
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—
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Sales force revenue
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74,219
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—
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296,875
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—
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||||
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Grant revenue
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—
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157,800
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—
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542,006
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Total revenues, net
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4,785,138
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157,800
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9,267,913
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542,006
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Operating expenses:
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Cost of product sales
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1,422,957
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—
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2,286,582
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—
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Research and development
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1,082,698
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493,649
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2,732,475
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1,446,719
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General and administrative
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3,041,955
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1,439,146
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5,949,318
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2,769,410
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Sales and marketing
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2,042,015
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—
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3,578,378
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—
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Amortization expense
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1,233,035
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—
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2,250,444
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—
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||||
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Impairment of intangible assets
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1,701,875
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—
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1,701,875
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—
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||||
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Total operating expenses
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10,524,535
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1,932,795
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18,499,072
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4,216,129
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||||
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Loss from operations
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(5,739,397
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)
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(1,774,995
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)
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(9,231,159
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)
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(3,674,123
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)
|
||||
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Other (expense) income:
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||||||||
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Change in fair value of contingent consideration, warrant liability and unit purchase option liability
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(9,321
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)
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2,111
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(295,340
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)
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(1,650
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)
|
||||
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Other income
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—
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—
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18,654
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—
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||||
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Interest expense, net
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(242,407
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)
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(25,631
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)
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(342,810
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)
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(83,379
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)
|
||||
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Total other expense, net
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(251,728
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)
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(23,520
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)
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(619,496
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)
|
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(85,029
|
)
|
||||
|
Net loss before taxes
|
|
(5,991,125
|
)
|
|
(1,798,515
|
)
|
|
(9,850,655
|
)
|
|
(3,759,152
|
)
|
||||
|
Income tax expense
|
|
16,351
|
|
|
—
|
|
|
39,664
|
|
|
—
|
|
||||
|
Net loss
|
|
$
|
(6,007,476
|
)
|
|
$
|
(1,798,515
|
)
|
|
$
|
(9,890,319
|
)
|
|
$
|
(3,759,152
|
)
|
|
Net loss per share of common stock, basic and diluted
|
|
$
|
(0.19
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.32
|
)
|
|
Weighted-average shares of common stock outstanding, basic and diluted
|
|
32,245,281
|
|
|
13,265,877
|
|
|
31,783,875
|
|
|
11,697,535
|
|
||||
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
Operating activities
|
|
|
|
|
||||
|
Net loss
|
|
$
|
(9,890,319
|
)
|
|
$
|
(3,759,152
|
)
|
|
Adjustments to reconcile net loss provided by (used in) to net cash used in operating activities:
|
|
|
|
|
||||
|
Depreciation and amortization
|
|
2,262,570
|
|
|
11,689
|
|
||
|
Impairment of Intangible assets
|
|
1,701,875
|
|
|
|
|||
|
Stock-based compensation expense
|
|
851,255
|
|
|
587,963
|
|
||
|
Deferred taxes
|
|
23,764
|
|
|
—
|
|
||
|
Amortization of inventory fair value associated with acquisition of TRx and Avadel
|
|
177,238
|
|
|
—
|
|
||
|
Non-cash interest expense
|
|
351,566
|
|
|
21,352
|
|
||
|
Change in fair value of warrant liability and unit purchase option liability
|
|
19,333
|
|
|
1,650
|
|
||
|
Change in fair value of contingent consideration
|
|
276,008
|
|
|
—
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
|
||||
|
Accounts receivable, net
|
|
(373,299
|
)
|
|
—
|
|
||
|
Grants receivable
|
|
—
|
|
|
57,230
|
|
||
|
Other receivables
|
|
339,221
|
|
|
—
|
|
||
|
Inventory, net
|
|
(617,619
|
)
|
|
—
|
|
||
|
Prepaid expenses and other assets
|
|
318,771
|
|
|
(11,040
|
)
|
||
|
Escrowed cash receivable
|
|
(5,287
|
)
|
|
—
|
|
||
|
Accounts payable
|
|
1,640,959
|
|
|
(682,907
|
)
|
||
|
Income taxes payable
|
|
(88,100
|
)
|
|
—
|
|
||
|
Accrued expenses and other liabilities
|
|
2,397,968
|
|
|
(222,303
|
)
|
||
|
Net cash used in operating activities
|
|
(614,096
|
)
|
|
(3,995,518
|
)
|
||
|
Investing activities
|
|
|
|
|
||||
|
Acquisition of business
|
|
(1
|
)
|
|
—
|
|
||
|
Purchase of property and equipment
|
|
(25,931
|
)
|
|
(1,801
|
)
|
||
|
Net cash used in investing activities
|
|
(25,932
|
)
|
|
(1,801
|
)
|
||
|
Financing activities
|
|
|
|
|
||||
|
Proceeds from option and warrant exercises
|
|
390,473
|
|
|
—
|
|
||
|
Proceeds from sale of shares pursuant to private placement, net
|
|
—
|
|
|
4,650,000
|
|
||
|
Proceeds from sales of common stock under employee stock purchase plan
|
|
8,400
|
|
|
35,431
|
|
||
|
Proceeds from sale of shares under common stock purchase agreement
|
|
—
|
|
|
1,693,498
|
|
||
|
Principal payments on term debt
|
|
—
|
|
|
(1,767,421
|
)
|
||
|
Payment of offering costs
|
|
—
|
|
|
(279,246
|
)
|
||
|
Net cash provided by financing activities
|
|
398,873
|
|
|
4,332,262
|
|
||
|
(Decrease) increase in cash, cash equivalents and restricted cash
|
|
(241,155
|
)
|
|
334,943
|
|
||
|
Cash, cash equivalents, and restricted cash at beginning of period
|
|
2,605,499
|
|
|
5,201,897
|
|
||
|
Cash, cash equivalents, and restricted cash at end of period
|
|
$
|
2,364,344
|
|
|
$
|
5,536,840
|
|
|
Supplemental disclosures of cash flow information
|
|
|
|
|
||||
|
Cash paid for interest
|
|
$
|
—
|
|
|
$
|
70,180
|
|
|
|
June 30,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
2,179,775
|
|
|
$
|
5,460,699
|
|
|
Restricted cash, current
|
9,527
|
|
|
13,300
|
|
||
|
Restricted cash, non-current
|
175,042
|
|
|
62,841
|
|
||
|
Total cash, cash equivalents and restricted cash
|
$
|
2,364,344
|
|
|
$
|
5,536,840
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||
|
Prescribed dietary supplements
|
|
$1,925,543
|
|
$
|
—
|
|
|
$3,669,791
|
|
$
|
—
|
|
||
|
Prescription drugs
|
|
2,785,376
|
|
|
—
|
|
|
5,301,247
|
|
|
—
|
|
||
|
Sales force revenue
|
|
74,219
|
|
|
—
|
|
|
296,875
|
|
|
—
|
|
||
|
Grant revenue
|
|
—
|
|
|
157,800
|
|
|
—
|
|
|
542,006
|
|
||
|
Total revenue
|
|
$4,785,138
|
|
$157,800
|
|
$9,267,913
|
|
$542,006
|
||||||
|
•
|
the shelf life or expiration date of each product;
|
|
•
|
historical levels of expired product returns;
|
|
•
|
external data with respect to inventory levels in the wholesale distribution channel;
|
|
•
|
external data with respect to prescription demand for the Company’s products; and
|
|
•
|
the estimated returns liability to be processed by year of sale based on analysis of lot information related to actual historical returns.
|
|
•
|
Portfolio approach - contracts within each revenue stream have similar characteristics and the Company believes this approach would not differ materially than if applying Topic 606 to each individual contract.
|
|
•
|
Modified retrospective approach - the Company applied Topic 606 only to contracts with customers which were not completed at the date of initial application, January 1, 2018.
|
|
•
|
Significant financing component - the Company does not adjust the promised amount of consideration for the effects of a significant financing component as the Company expects, at contract inception, that the period between when the Company transfers a promised good or service to a customer and when the customer pays for that good or service will be one year or less.
|
|
•
|
Shipping and handling activities - the Company considers any shipping and handling costs that are incurred after the customer has obtained control of the product as a cost to fulfill a promise and will account for them as an expense.
|
|
•
|
Contract costs - the Company recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less.
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
Net loss per share, basic and diluted calculation
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Basic and diluted loss per share:
|
|
|
|
|
|
|
|
|
||||||||
|
Net loss
|
|
$
|
(6,007,476
|
)
|
|
$
|
(1,798,515
|
)
|
|
$
|
(9,890,319
|
)
|
|
$
|
(3,759,152
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Weighted average shares, basic and diluted
|
|
|
|
|
|
|
|
|
||||||||
|
Common stock
|
|
32,245,281
|
|
|
13,265,877
|
|
|
31,783,875
|
|
|
11,697,535
|
|
||||
|
Participating warrants
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
|
|
32,245,281
|
|
|
13,265,877
|
|
|
31,783,875
|
|
|
11,697,535
|
|
||||
|
Basic and diluted loss per share:
|
|
|
|
|
|
|
|
|
||||||||
|
Common stock
|
|
$
|
(0.19
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.32
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||
|
|
|
June 30,
|
|
June 30,
|
||||||||
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
|
Stock options
|
|
4,104,574
|
|
2,198,630
|
|
4,104,574
|
|
2,198,630
|
||||
|
Warrants on common stock
|
|
18,986,559
|
|
19,001,143
|
|
18,986,559
|
|
19,001,143
|
||||
|
Restricted Stock Awards
|
|
400,000
|
|
—
|
|
|
400,000
|
|
—
|
|
||
|
Underwriters' unit purchase option
|
|
40,000
|
|
40,000
|
|
40,000
|
|
40,000
|
||||
|
Convertible preferred shares
|
|
—
|
|
|
11,940,000
|
|
—
|
|
|
11,940,000
|
||
|
|
|
|
|
|
||||||
|
|
|
|
|
|
||||||
|
|
|
At February 16,
2018 (preliminary)
|
Measurement Period Adjustments
|
At February 16,
2018 (as adjusted)
|
||||||
|
|
|
|
|
|
||||||
|
Inventory
|
|
$
|
2,549,000
|
|
$
|
(1,831,000
|
)
|
$
|
718,000
|
|
|
Prepaid assets
|
|
—
|
|
570,000
|
|
570,000
|
|
|||
|
Intangible assets
|
|
16,453,000
|
|
1,838,000
|
|
18,291,000
|
|
|||
|
Accrued expenses
|
|
—
|
|
(362,000
|
)
|
(362,000
|
)
|
|||
|
Fair value of debt assumed
|
|
(15,272,303
|
)
|
197,303
|
|
(15,075,000
|
)
|
|||
|
Fair value of contingent consideration and deferred payments
|
|
(7,875,165
|
)
|
(44,835
|
)
|
(7,920,000
|
)
|
|||
|
Total net liabilities assumed
|
|
(4,145,468
|
)
|
367,468
|
|
(3,778,000
|
)
|
|||
|
Consideration exchanged
|
|
241,000
|
|
(240,999
|
)
|
1
|
|
|||
|
Goodwill
|
|
$
|
4,386,468
|
|
$
|
(608,467
|
)
|
$
|
3,778,001
|
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
|
|
|
At February 16,
2018 (preliminary)
|
Measurement Period Adjustments
|
At February 16,
2018 (as adjusted)
|
Useful Life
|
||||||
|
|
|
|
|
|
|
||||||
|
Acquired Product Marketing Rights - Karbinal
|
|
$
|
6,221,000
|
|
$
|
(21,000
|
)
|
$
|
6,200,000
|
|
16 years
|
|
Acquired Product Marketing Rights - AcipHex
|
|
2,520,000
|
|
283,000
|
|
2,803,000
|
|
10 years
|
|||
|
Acquired Product Marketing Rights - Cefaclor
|
|
6,291,000
|
|
1,320,000
|
|
7,611,000
|
|
7 years
|
|||
|
Acquired Developed Technology - Flexichamber
|
|
1,131,000
|
|
546,000
|
|
1,677,000
|
|
10 years
|
|||
|
Acquired IPR&D - LiquiTime formulations
|
|
290,000
|
|
(290,000
|
)
|
—
|
|
Indefinite
|
|||
|
Total
|
|
$
|
16,453,000
|
|
$
|
1,838,000
|
|
$
|
18,291,000
|
|
|
|
Cash
|
|
$
|
18,900,000
|
|
|
Common stock (including contingently issuable shares)
|
|
8,514,419
|
|
|
|
Contingent payments
|
|
2,576,633
|
|
|
|
Total consideration transferred
|
|
$
|
29,991,052
|
|
|
|
|
Amounts Recognized
|
||
|
|
|
as of Acquisition Date
|
||
|
|
|
(as previously reported)
|
||
|
Fair value of assets acquired:
|
|
|
||
|
Cash and cash equivalents
|
|
$
|
11,068
|
|
|
Accounts receivable, net
|
|
2,872,545
|
|
|
|
Inventory
|
|
495,777
|
|
|
|
Prepaid expenses and other current assets
|
|
134,281
|
|
|
|
Identifiable Intangible Assets:
|
|
|
|
|
|
Acquired product marketing rights - Metafolin
|
|
10,465,000
|
|
|
|
PAI sales and marketing agreement
|
|
2,334,000
|
|
|
|
Acquired product marketing rights - Millipred
|
|
4,714,000
|
|
|
|
Acquired product marketing rights - Ulesfia
|
|
555,000
|
|
|
|
Total assets acquired
|
|
$
|
21,581,671
|
|
|
|
|
|
||
|
Fair value of liabilities assumed:
|
|
|
||
|
Accounts payable
|
|
$
|
192,706
|
|
|
Accrued expenses and other current liabilities
|
|
4,850,422
|
|
|
|
Deferred tax liability
|
|
839,773
|
|
|
|
Total liabilities assumed
|
|
5,882,901
|
|
|
|
Total identifiable net assets
|
|
15,698,770
|
|
|
|
Fair value of consideration transferred
|
|
29,991,052
|
|
|
|
Goodwill
|
|
$
|
14,292,282
|
|
|
|
|
|
|
|
|
||||||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||
|
|
2018
|
2017
|
|
2018
|
2017
|
||||||||
|
|
Pro forma
|
Pro forma
|
|
Pro forma
|
Pro forma
|
||||||||
|
|
|
|
|
|
|
||||||||
|
Total revenues, net
|
$
|
4,785,138
|
|
$
|
5,250,190
|
|
|
$
|
10,972,913
|
|
$
|
10,310,980
|
|
|
Net loss
|
$
|
(5,991,125
|
)
|
$
|
(4,541,967
|
)
|
|
$
|
(10,935,919
|
)
|
$
|
(8,375,360
|
)
|
|
Diluted net loss per share
|
$(0.19)
|
$(0.25)
|
|
$(0.34)
|
$(0.50)
|
||||||||
|
|
|
|
|
|
|
||||||||
|
•
|
Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.
|
|
•
|
Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model‑derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.
|
|
•
|
Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.
|
|
|
|
June 30, 2018
|
||||||||||
|
|
|
Fair Value Measurements Using
|
||||||||||
|
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
|
Assets
|
|
|
|
|
|
|
||||||
|
Investments in money market funds*
|
|
$
|
52,589
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
||||||
|
Contingent consideration
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,772,641
|
|
|
Warrant liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,330
|
|
|
Unit purchase option liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
40,179
|
|
|
|
|
December 31, 2017
|
||||||||||
|
|
|
Fair Value Measurements Using
|
||||||||||
|
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
|
Assets
|
|
|
|
|
|
|
||||||
|
Investments in money market funds*
|
|
$
|
471,183
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
||||||
|
Contingent consideration
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,576,633
|
|
|
Warrant liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,185
|
|
|
Unit purchase option liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
26,991
|
|
|
|
|
Warrant liability
|
|
Unit purchase option liability
|
|
Contingent Consideration
|
|
Total
|
||||||||
|
Balance at December 31, 2017
|
|
$
|
8,185
|
|
|
$
|
26,991
|
|
|
$
|
2,576,633
|
|
|
$
|
2,611,809
|
|
|
Issuance of contingent consideration
|
|
—
|
|
|
—
|
|
|
7,920,000
|
|
|
7,920,000
|
|
||||
|
Change in fair value
|
|
6,145
|
|
|
13,188
|
|
|
276,008
|
|
|
295,341
|
|
||||
|
Balance at June 30, 2018
|
|
$
|
14,330
|
|
|
$
|
40,179
|
|
|
$
|
10,772,641
|
|
|
$
|
10,827,150
|
|
|
|
|
Warrant
|
|
Unit purchase
|
|
|
||||||
|
|
|
liability
|
|
option liability
|
|
Total
|
||||||
|
Balance at December 31, 2016
|
|
$
|
5,501
|
|
|
$
|
51
|
|
|
$
|
5,552
|
|
|
Change in fair value
|
|
(4,906
|
)
|
|
6,556
|
|
|
1,650
|
|
|||
|
Balance at June 30, 2017
|
|
$
|
595
|
|
|
$
|
6,607
|
|
|
$
|
7,202
|
|
|
|
|
As of
|
||||||
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
|
Sales returns and allowances
|
|
$
|
6,069,938
|
|
|
$
|
3,829,030
|
|
|
Compensation and benefits
|
|
1,447,418
|
|
|
1,401,514
|
|
||
|
General and administrative
|
|
555,238
|
|
|
1,001,454
|
|
||
|
Royalties payable
|
|
846,251
|
|
|
743,010
|
|
||
|
Minimum sales commitment
|
|
819,375
|
|
|
—
|
|
||
|
Research and development expenses
|
|
224,496
|
|
|
299,480
|
|
||
|
Other
|
|
371,979
|
|
|
256,634
|
|
||
|
Total accrued expenses and other current liabilities
|
|
$
|
10,334,695
|
|
|
$
|
7,531,122
|
|
|
Number of shares
|
|
Exercise price
|
|
Expiration
|
||
|
underlying warrants
|
|
per share
|
|
date
|
||
|
80,966
|
|
$
|
28.00
|
|
|
August 2018
|
|
4,551,600
|
|
$
|
4.55
|
|
|
October 2018
|
|
40,000*
|
|
$
|
5.23
|
|
|
October 2018
|
|
3,571
|
|
$
|
28.00
|
|
|
December 2018
|
|
22,328*
|
|
$
|
8.40
|
|
|
October 2020
|
|
2,380*
|
|
$
|
8.68
|
|
|
May 2022
|
|
14,285,714
|
|
$
|
0.40
|
|
|
June 2022
|
|
18,986,559
|
|
|
|
|
||
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Research and development
|
|
$
|
20,379
|
|
|
$
|
33,217
|
|
|
$
|
31,876
|
|
|
$
|
80,783
|
|
|
General and administrative
|
|
549,199
|
|
|
222,526
|
|
|
756,581
|
|
|
507,180
|
|
||||
|
Sales and marketing
|
|
38,853
|
|
|
—
|
|
|
62,798
|
|
|
—
|
|
||||
|
Total stock-based compensation
|
|
$
|
608,431
|
|
|
$
|
255,743
|
|
|
$
|
851,255
|
|
|
$
|
587,963
|
|
|
|
|
Options Outstanding
|
|||||||||||
|
|
|
Number of shares
|
|
Weighted average exercise price
|
|
Grant date fair value of options
|
|
Weighted average remaining contractual term (in years)
|
|||||
|
Balance at December 31, 2017
|
|
2,823,489
|
|
|
$
|
3.93
|
|
|
|
|
|
7.29
|
|
|
Granted
|
|
1,286,622
|
|
|
$
|
3.80
|
|
|
$
|
2,904,560
|
|
|
|
|
Exercised
|
|
(153,431
|
)
|
|
$
|
2.54
|
|
|
|
|
|
||
|
Forfeited
|
|
(352,106
|
)
|
|
$
|
2.07
|
|
|
|
|
|
|
|
|
Balance at June 30, 2018
|
|
3,604,574
|
|
|
$
|
4.12
|
|
|
|
|
|
7.97
|
|
|
Exercisable at June 30, 2018
|
|
1,784,750
|
|
|
$
|
4.88
|
|
|
|
|
|
6.59
|
|
|
|
|
Options Outstanding
|
|||||||||
|
|
|
Number of shares
|
|
Weighted average exercise price
|
|
Weighted average remaining contractual term (in years)
|
|
Aggregate intrinsic value (1)
|
|||
|
Balance at December 31, 2017
|
|
—
|
|
|
|
|
|
|
|
||
|
Granted
|
|
500,000
|
|
|
$
|
4.24
|
|
|
|
|
|
|
Exercised
|
|
—
|
|
|
|
|
|
|
|
||
|
Forfeited
|
|
—
|
|
|
|
|
|
|
|
||
|
Balance at June 30, 2018
|
|
500,000
|
|
|
$
|
4.24
|
|
|
9.74
|
|
$50,000
|
|
Exercisable at June 30, 2018
|
|
—
|
|
|
|
|
|
|
|
||
|
Service-based options
|
|
|
|
Expected dividend yield
|
|
—%
|
|
Expected volatility
|
|
55 - 65%
|
|
Expected life (in years)
|
|
5.0 - 6.25
|
|
Risk-free interest rate
|
|
2.53 - 2.93%
|
|
|
|
|
|
Market-based options
|
|
|
|
Expected dividend yield
|
|
—%
|
|
Expected volatility
|
|
60%
|
|
Expected life (in years)
|
|
10
|
|
Risk-free interest rate
|
|
2.84%
|
|
|
|
Non-vested RSAs Outstanding
|
|||||
|
|
|
Number of shares
|
|
Weighted average grant date fair value
|
|||
|
Non-vested RSAs at December 31, 2017
|
|
—
|
|
|
$
|
—
|
|
|
Granted
|
|
400,000
|
|
|
$
|
4.24
|
|
|
Vested
|
|
—
|
|
|
$
|
—
|
|
|
Forfeited
|
|
—
|
|
|
$
|
—
|
|
|
Non-vested RSAs at June 30, 2018
|
|
400,000
|
|
|
|
||
|
•
|
CERC-301:
Orphan Neurological Indication
.
CERC‑301 belongs to a class of compounds known as antagonists of the N‑methyl‑D‑aspartate, or NMDA, receptor, a receptor subtype of the glutamate neurotransmitter system that is responsible for controlling neurologic adaptation. We believe CERC‑301 selectively blocks the NMDA receptor subunit 2B, or NR2B (also called GluN2B). Given its specific mechanism of action and demonstrated tolerability profile, we believe CERC-301 may be well suited to address unmet medical needs in neurologic indications. We initiated a Phase I study in 2018 for neurogenic orthostatic hypotension (“nOH”), a condition that is part of a larger category called orthostatic hypotension (OH), which is also known as postural hypotension. nOH is caused by dysfunction in the autonomic nervous system and causes people to feel faint when they stand or sit up. We will continue to explore the use of CERC-301 in orphan neurologic conditions in preclinical and clinical studies.
|
|
•
|
CERC-611:
Adjunctive Treatment of Partial-Onset Seizures in Epilepsy.
CERC-611 is a potent and selective antagonist of transmembrane alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor regulatory protein (“TARP”)-ã8-dependent AMPA receptor in preclinical development. TARPs are a recently discovered family of proteins that have been found to associate with, and modulate the activity of, AMPA receptors. TARP y8-dependent AMPA receptors are localized primarily in the hippocampus, a region of the brain with importance in complex partial seizures and particularly relevant to seizure origination and/or propagation. We believe CERC-611 is the first drug candidate to selectively target and functionally block region-specific AMPA receptors after oral dosing, which we believe may improve the efficacy and side effect profile of CERC-611 over current anti-epileptics. Research also suggests that selectively targeting individual TARPs may enable selective modulation of specific brain circuits without globally affecting synaptic transmission. We intend to develop CERC-611 as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy.
|
|
•
|
CERC-406 and CERC-425:
Residual Motoric and Cognitive Impairment.
CERC-406 and CERC-425 are preclinical candidates from our proprietary platform of compounds that inhibit catechol-O-methyltransferase, or COMT, within the brain, which we refer to as our COMTi platform. We believe they may have the potential to be developed for the treatment of residual cognitive impairment symptoms such as Parkinson’s disease.
|
|
•
|
Growing sales of the existing commercial products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;
|
|
•
|
Acquiring or licensing rights to clinically meaningful and differentiated products that are already on the market for pediatric use or in late-stage development for pediatric indications that are near market launch; and
|
|
•
|
Pursuing targeted, differentiated clinical stage product candidates for rare disorders or orphan diseases.
|
|
•
|
the shelf life or expiration date of each product;
|
|
•
|
historical levels of expired product returns;
|
|
•
|
external data with respect to inventory levels in the wholesale distribution channel;
|
|
•
|
external data with respect to prescription demand for our products; and
|
|
•
|
the estimated returns liability to be processed by year of sale based on analysis of lot information related to actual historical returns.
|
|
•
|
declining sales trends based on prescription demand;
|
|
•
|
regulatory approvals that could shorten the shelf life of our products, which could result in a period of higher returns related to older product still in the distribution channel;
|
|
•
|
introduction of new product or generic competition; and
|
|
•
|
increasing price competition from generic competitors.
|
|
•
|
Portfolio approach - contracts within each revenue stream have similar characteristics and we believe this approach would not differ materially than if applying Topic 606 to each individual contract.
|
|
•
|
Modified retrospective approach - we applied Topic 606 only to contracts with customers which were not completed at the date of initial application, January 1, 2018.
|
|
•
|
Significant financing component - we did not adjust the promised amount of consideration for the effects of a significant financing component as we expect, at contract inception, that the period between when we transfer a promised good or service to a customer and when the customer pays for that good or service will be one year or less.
|
|
•
|
Shipping and handling activities - we consider any shipping and handling costs that are incurred after the customer has obtained control of the product as a cost to fulfill a promise and will account for them as an expense.
|
|
•
|
Contract costs - we recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that we otherwise would have recognized is one year or less.
|
|
•
|
expenses incurred under agreements with third‑party contract research organizations and investigative sites that conduct our clinical trials, preclinical studies and regulatory activities;
|
|
•
|
payments made to contract manufacturers for drug substance and acquiring, developing and manufacturing clinical trial materials;
|
|
•
|
payments related to acquisitions of our product candidates and preclinical platform; and
|
|
•
|
milestone payments, and fees associated with the prosecution and maintenance of patents.
|
|
•
|
personnel‑related expenses, including salaries, benefits and stock‑based compensation expense and travel expenses;
|
|
•
|
consulting costs related to our internal research and development programs; allocated facilities, depreciation and other expenses, which include rent and utilities, as well as other supplies and licensing fees;
|
|
•
|
software licensing;
|
|
•
|
questionnaire costs; and
|
|
•
|
product liability insurance.
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
(in thousands)
|
||||||||||||||
|
GAAP Net loss
|
|
$
|
(6,007
|
)
|
|
$
|
(1,799
|
)
|
|
$
|
(9,890
|
)
|
|
$
|
(3,759
|
)
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
||||||||
|
Income tax expense
|
|
16
|
|
|
—
|
|
|
40
|
|
|
—
|
|
||||
|
Interest expense, net
|
|
242
|
|
|
26
|
|
|
343
|
|
|
83
|
|
||||
|
Amortization of intangible assets
|
|
1,233
|
|
|
—
|
|
|
2,250
|
|
|
—
|
|
||||
|
Depreciation
|
|
6
|
|
|
6
|
|
|
12
|
|
|
6
|
|
||||
|
Inventory step-up adjustment recorded in earnings
|
|
132
|
|
|
—
|
|
|
177
|
|
|
—
|
|
||||
|
EBITDA
|
|
$
|
(4,378
|
)
|
|
$
|
(1,767
|
)
|
|
$
|
(7,068
|
)
|
|
$
|
(3,670
|
)
|
|
Non-GAAP Adjustments:
|
|
|
|
|
|
|
|
|
||||||||
|
Share based compensation
|
|
608
|
|
|
256
|
|
|
851
|
|
|
588
|
|
||||
|
Change in fair value of contingent consideration, warrant liability and unit purchase option liability
|
|
9
|
|
|
(2
|
)
|
|
295
|
|
|
2
|
|
||||
|
Restructuring costs
|
|
—
|
|
|
—
|
|
|
213
|
|
|
—
|
|
||||
|
Acquisition and integration related expenses
|
|
361
|
|
|
—
|
|
|
678
|
|
|
—
|
|
||||
|
Impairment of intangible assets
|
|
1,702
|
|
|
—
|
|
|
1,702
|
|
|
—
|
|
||||
|
Lachlan legal arbitration costs
|
|
437
|
|
|
—
|
|
|
860
|
|
|
—
|
|
||||
|
Total Non-GAAP Adjustments
|
|
3,117
|
|
|
254
|
|
|
4,599
|
|
|
590
|
|
||||
|
Adjusted EBITDA
|
|
$
|
(1,261
|
)
|
|
$
|
(1,513
|
)
|
|
$
|
(2,469
|
)
|
|
$
|
(3,080
|
)
|
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Product revenue, net
|
|
$
|
4,711
|
|
|
$
|
—
|
|
|
Sales force revenue
|
|
$
|
74
|
|
|
$
|
—
|
|
|
Grant revenue
|
|
$
|
—
|
|
|
$
|
158
|
|
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Preclinical expenses
|
|
$
|
396
|
|
|
$
|
24
|
|
|
Clinical expenses
|
|
351
|
|
|
186
|
|
||
|
CMC expenses
|
|
33
|
|
|
27
|
|
||
|
Internal expenses not allocated to programs:
|
|
|
|
|
|
|
||
|
Salaries, benefits and related costs
|
|
236
|
|
|
199
|
|
||
|
Stock-based compensation expense
|
|
20
|
|
|
34
|
|
||
|
Other
|
|
47
|
|
|
24
|
|
||
|
|
|
$
|
1,083
|
|
|
$
|
493
|
|
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Salaries, benefits and related costs
|
|
$
|
836
|
|
|
$
|
589
|
|
|
Legal, consulting and other professional expenses
|
|
1,543
|
|
|
523
|
|
||
|
Stock-based compensation expense
|
|
549
|
|
|
222
|
|
||
|
Other
|
|
114
|
|
|
105
|
|
||
|
|
|
$
|
3,042
|
|
|
$
|
1,439
|
|
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Salaries, benefits and related costs
|
|
$
|
1,424
|
|
|
$
|
—
|
|
|
Logistics, insurance and other commercial operations expenses
|
|
75
|
|
|
—
|
|
||
|
Stock-based compensation expense
|
|
39
|
|
|
—
|
|
||
|
Advertising and marketing expense
|
|
136
|
|
|
—
|
|
||
|
Contract related expenses
|
|
342
|
|
|
—
|
|
||
|
Other
|
|
26
|
|
|
—
|
|
||
|
|
|
$
|
2,042
|
|
|
$
|
—
|
|
|
|
|
|
Three Months Ended June 30,
|
||||||
|
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
(in thousands)
|
||||||
|
Amortization of intangible assets
|
|
$
|
1,233
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Product revenue, net
|
|
$
|
8,971
|
|
|
$
|
—
|
|
|
Sales force revenue
|
|
$
|
297
|
|
|
$
|
—
|
|
|
Grant revenue
|
|
$
|
—
|
|
|
$
|
542
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Preclinical expenses
|
|
$
|
1,282
|
|
|
$
|
71
|
|
|
Clinical expenses
|
|
649
|
|
|
361
|
|
||
|
CMC expenses
|
|
140
|
|
|
319
|
|
||
|
Internal expenses not allocated to programs:
|
|
|
|
|
|
|
||
|
Salaries, benefits and related costs
|
|
485
|
|
|
549
|
|
||
|
Stock-based compensation expense
|
|
32
|
|
|
83
|
|
||
|
Other
|
|
144
|
|
|
64
|
|
||
|
|
|
$
|
2,732
|
|
|
$
|
1,447
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Salaries, benefits and related costs
|
|
$
|
1,475
|
|
|
$
|
922
|
|
|
Legal, consulting and other professional expenses
|
|
3,527
|
|
|
1,103
|
|
||
|
Stock-based compensation expense
|
|
757
|
|
|
505
|
|
||
|
Other
|
|
190
|
|
|
239
|
|
||
|
|
|
$
|
5,949
|
|
|
$
|
2,769
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Salaries, benefits and related costs
|
|
$
|
2,629
|
|
|
$
|
—
|
|
|
Logistics, insurance and other commercial operations expenses
|
|
168
|
|
|
—
|
|
||
|
Stock-based compensation expense
|
|
63
|
|
|
—
|
|
||
|
Advertising and marketing expense
|
|
312
|
|
|
—
|
|
||
|
Contract related expenses
|
|
342
|
|
|
—
|
|
||
|
Other
|
|
64
|
|
|
—
|
|
||
|
|
|
$
|
3,578
|
|
|
$
|
—
|
|
|
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
(in thousands)
|
||||||
|
Amortization of intangible assets
|
|
$
|
2,250
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
Deerfield Obligation
|
|
$
|
15,426,566
|
|
|
$
|
—
|
|
|
Less: debt discount
|
|
—
|
|
|
—
|
|
||
|
Deerfield Obligation, net of debt discount
|
|
15,426,566
|
|
|
—
|
|
||
|
Less: current portion
|
|
1,050,000
|
|
|
—
|
|
||
|
Long term debt, net of current portion and debt discount
|
|
$
|
14,376,566
|
|
|
$
|
—
|
|
|
|
|
|
|
|
||||
|
|
|
Six Months Ended June 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Net cash provided by (used in):
|
|
|
|
|
||||
|
Operating activities
|
|
$
|
(614
|
)
|
|
$
|
(3,996
|
)
|
|
Investing activities
|
|
(26
|
)
|
|
(2
|
)
|
||
|
Financing activities
|
|
399
|
|
|
4,332
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
|
$
|
(241
|
)
|
|
$
|
335
|
|
|
•
|
profits of our marketed products
|
|
•
|
the progress of clinical trials for CERC-301 and any changes to our development plan with respect to CERC-301 or our other developmental compounds, if any;
|
|
•
|
our plan and ability to enter into collaborative agreements for the development and commercialization of our product candidates;
|
|
•
|
the scope, progress, results and costs of researching and developing our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
|
•
|
the costs, timing and outcome of regulatory review of our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
|
•
|
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution for any of our product candidates for which we receive marketing approval;
|
|
•
|
the costs and timing of any product candidate acquisition or in‑licensing opportunities;
|
|
•
|
any product liability or other lawsuits related to our products;
|
|
•
|
the expenses needed to attract and retain skilled personnel;
|
|
•
|
the profits, if any, received from commercial sales of our product candidates for which we receive marketing approval; and
|
|
•
|
the costs involved in preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending our intellectual property‑related claims, both in the United States and in territories outside the United States
|
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
|
|
|
|
3.1
|
|
|
|
|
|
|
|
|
|
3.2
|
|
|
|
|
|
|
|
|
|
10.1#
|
|
|
|
|
|
|
|
|
|
10.2#
|
|
|
|
|
|
|
|
|
|
10.3#
|
|
|
|
|
|
|
|
|
|
10.4#
|
|
|
|
|
|
|
|
|
|
31.1
|
|
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
|
|
|
|
101.INS
|
|
|
XBRL Instance Document.
|
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101.SCH
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XBRL Taxonomy Extension Schema Document.
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document.
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document.
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101.LAB
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XBRL Taxonomy Extension Label Linkbase Document
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SIGNATURES
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Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Cerecor Inc.
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Date: August 9, 2018
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/s/ Peter Greenleaf
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Peter Greenleaf
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Chief Executive Officer
(on behalf of the registrant and as the registrant’s Principal Executive Officer)
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Date: August 9, 2018
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/s/ Joseph M. Miller
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Joseph M. Miller
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Chief Financial Officer
(Principal Financial Officer)
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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 |
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| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
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No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|