Delaware
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001-38599
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82-3827296
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.001 per share
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AQST
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Nasdaq Global Market
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Item 2.02
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Results of Operations and Financial Condition
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Item 9.01
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Financial Statements and Exhibits
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(d)
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Exhibits.
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Exhibit Number
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Description
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|
Press Release, dated November 5, 2019, announcing financial results for the three and nine months ended September 30, 2019 and 2018, respectively.
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Dated: November 5, 2019
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Aquestive Therapeutics, Inc.
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By:
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/s/ John T. Maxwell
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Name: John T. Maxwell
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||
Title: Chief Financial Officer
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● |
Increased full year 2019 revenue and earnings guidance
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● |
Expected to complete its rolling New Drug Application (NDA) submission for Libervant™ (diazepam) Buccal Film around the end of November 2019
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● |
Reported successful completion of its Phase 1 dose escalation proof-of-concept study in healthy subjects for AQST-108, oral sublingual film formulation delivering systemic epinephrine for the treatment of
allergic reactions including anaphylaxis
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● |
Hosts investment community conference call at 8:00 a.m. ET on November 6, 2019
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● |
Aquestive is expected to complete its rolling NDA submission for Libervant (diazepam) Buccal Film around the end of November 2019, after having filed the CMC portion in September 2019. Libervant has the
potential to be the first oral therapy approved by the FDA for the management of seizure clusters in the population of 1.2 million refractory epilepsy patients and the first diazepam based treatment usable by and delivering a consistent
predictable dose to virtually all patients to whom it is prescribed.
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● |
Positive data reported from Phase 1 dose escalation proof-of-concept study in healthy subjects for AQST-108, a “first in class” oral sublingual film formulation of epinephrine, demonstrated the ability to
deliver systemic epinephrine using Aquestive’s proprietary PharmFilm formulation.
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● |
Sympazan® (clobazam) Oral Film for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) continues to grow, with shipments to retailers increasing over 50% as compared to the quarter
ended in June.
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● |
Total revenues of $45 million to $47 million;
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● |
Non-GAAP gross margins of 67% to 69% on total revenues;
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● |
Non-GAAP Adjusted EBITDA loss of $49 million to $50 million; and
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● |
Cash burn of approximately $60 million to $65 million after considering interest, capital spending and working capital effects, but prior to any additional non-dilutive capital transactions.
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• |
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
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• |
Limit dosages and durations to the minimum required.
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• |
Follow patients for signs and symptoms of respiratory depression and sedation.
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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|||||||||||||||
2019
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2018
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2019
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2018
|
|||||||||||||
Revenues
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$
|
12,418
|
$
|
13,267
|
$
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36,190
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$
|
50,606
|
||||||||
Costs and Expenses:
|
||||||||||||||||
Manufacture and supply
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4,643
|
5,592
|
13,569
|
16,201
|
||||||||||||
Research and development
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5,063
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4,534
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17,517
|
17,429
|
||||||||||||
Selling, general and administrative
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13,714
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12,346
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47,868
|
53,559
|
||||||||||||
Total costs and expenses
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23,420
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22,472
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78,954
|
87,189
|
||||||||||||
(Loss) from operations
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(11,002
|
)
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(9,205
|
)
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(42,764
|
)
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(36,583
|
)
|
||||||||
Other income/(expenses):
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||||||||||||||||
Interest expense
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(2,652
|
)
|
(1,933
|
)
|
(6,515
|
)
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(5,809
|
)
|
||||||||
Interest income
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138
|
216
|
565
|
238
|
||||||||||||
Loss on extinguishment of debt
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(4,896
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)
|
-
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(4,896
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)
|
-
|
||||||||||
Change in fair value of warrant
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-
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(4,116
|
)
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-
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(5,278
|
)
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||||||||||
Net (loss) before income taxes
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(18,412
|
)
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(15,038
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)
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(53,610
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)
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(47,432
|
)
|
||||||||
Income taxes
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-
|
-
|
-
|
-
|
||||||||||||
Net (loss)
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(18,412
|
)
|
(15,038
|
)
|
(53,610
|
)
|
(47,432
|
)
|
||||||||
Comprehensive (loss)
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$
|
(18,412
|
)
|
$
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(15,038
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)
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$
|
(53,610
|
)
|
$
|
(47,432
|
)
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||||
Net (loss) per share - basic and diluted
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$
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(0.74
|
)
|
$
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(0.64
|
)
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$
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(2.15
|
)
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$
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(2.45
|
)
|
||||
Weighted-average number of common shares outstanding - basic and diluted
|
25,031,478
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23,646,192
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24,992,229
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19,335,541
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September 30,
2019
|
December 31,
2018
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|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
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$
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20,914
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$
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60,599
|
||||
Accounts receivable, net
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10,316
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6,481
|
||||||
Inventories, net
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4,124
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5,441
|
||||||
Prepaid expenses and other current assets
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2,706
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1,680
|
||||||
Total current assets
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38,060
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74,201
|
||||||
Property and equipment, net
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10,351
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12,207
|
||||||
Intangible assets, net
|
165
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204
|
||||||
Other assets
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242
|
239
|
||||||
Total assets
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$
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48,818
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$
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86,851
|
||||
Liabilities and shareholders’ (deficit)/equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
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$
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19,218
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$
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27,631
|
||||
Deferred revenue, current
|
835
|
721
|
||||||
Loans payable, current
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-
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4,600
|
||||||
Total current liabilities
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20,053
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32,952
|
||||||
Loans payable, net
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59,775
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42,603
|
||||||
Deferred revenue, net of current portion
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2,127
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-
|
||||||
Asset retirement obligations
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1,322
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1,216
|
||||||
Total liabilities
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83,277
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76,771
|
||||||
Commitments and contingencies
|
||||||||
Shareholders’ (deficit)/equity:
|
||||||||
Common stock, $.001 par value. Authorized 250,000,000 shares; 25,042,964 and 24,957,309 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively
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25
|
25
|
||||||
Additional paid-in capital
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83,354
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71,431
|
||||||
Accumulated deficit
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(117,838
|
)
|
(61,376
|
)
|
||||
Total shareholders’ (deficit)/equity
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(34,459
|
)
|
10,080
|
|||||
Total liabilities and shareholders’ (deficit) /equity
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$
|
48,818
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$
|
86,851
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Total Costs and Expenses
|
$
|
23,420
|
$
|
22,472
|
$
|
78,954
|
$
|
87,189
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(1,869
|
)
|
(1,236
|
)
|
(5,199
|
)
|
(28,541
|
)
|
||||||||
Depreciation and Amortization
|
(707
|
)
|
(746
|
)
|
(2,182
|
)
|
(2,476
|
)
|
||||||||
Adjusted Costs and Expenses
|
$
|
20,844
|
$
|
20,490
|
$
|
71,573
|
$
|
56,172
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Manufacture and Supply Expense
|
$
|
4,643
|
$
|
5,592
|
$
|
13,569
|
$
|
16,201
|
||||||||
Gross Margin on total revenue
|
63
|
%
|
58
|
%
|
63
|
%
|
68
|
%
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(60
|
)
|
(32
|
)
|
(176
|
)
|
(377
|
)
|
||||||||
Depreciation and Amortization
|
(572
|
)
|
(602
|
)
|
(1,765
|
)
|
(2,003
|
)
|
||||||||
Adjusted Manufacture and Supply Expense
|
$
|
4,011
|
$
|
4,958
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$
|
11,628
|
$
|
13,821
|
||||||||
Non-GAAP Gross Margin on total revenue
|
68
|
%
|
63
|
%
|
68
|
%
|
73
|
%
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Research and Development Expense
|
$
|
5,063
|
$
|
4,534
|
$
|
17,517
|
$
|
17,429
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(187
|
)
|
(192
|
)
|
(535
|
)
|
(2,378
|
)
|
||||||||
Depreciation and Amortization
|
(79
|
)
|
(117
|
)
|
(200
|
)
|
(259
|
)
|
||||||||
Adjusted Research and Development Expense
|
$
|
4,797
|
$
|
4,225
|
$
|
16,782
|
$
|
14,792
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Selling, General and Administrative Expenses
|
$
|
13,714
|
$
|
12,346
|
$
|
47,868
|
$
|
53,559
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(1,622
|
)
|
(1,012
|
)
|
(4,488
|
)
|
(25,786
|
)
|
||||||||
Depreciation and Amortization
|
(57
|
)
|
(27
|
)
|
(217
|
)
|
(214
|
)
|
||||||||
Adjusted Selling, General and Administrative Expenses
|
$
|
12,035
|
$
|
11,307
|
$
|
43,163
|
$
|
27,559
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Net loss
|
$
|
(18,412
|
)
|
$
|
(15,038
|
)
|
$
|
(53,610
|
)
|
$
|
(47,432
|
)
|
||||
Share-based Compensation Expense
|
1,869
|
1,236
|
5,199
|
28,541
|
||||||||||||
Interest Expense, net
|
2,514
|
1,717
|
5,950
|
5,571
|
||||||||||||
Income Taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Depreciation and Amortization
|
707
|
746
|
2,182
|
2,476
|
||||||||||||
Loss on Extinguishment of Debt
|
4,896
|
-
|
4,896
|
-
|
||||||||||||
Change in Fair Value of Warrant
|
-
|
4,116
|
-
|
5,278
|
||||||||||||
Adjusted EBITDA
|
$
|
(8,426
|
)
|
$
|
(7,223
|
)
|
$
|
(35,383
|
)
|
$
|
(5,566
|
)
|