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 |
Results of Operations and Financial Condition
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Item 9.01 |
Financial Statements and Exhibits
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Exhibit Number
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Description
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Press Release, dated March 11, 2020, announcing the financial results for the quarter and fiscal year ended December 31, 2019.
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Dated: March 11, 2020
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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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• |
Expects to submit IND application for AQST-108 (epinephrine) in second quarter 2020 and commence pharmacokinetics (PK) clinical trials before end of 2020
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• |
FDA sets Libervant™ (diazepam) Buccal Film PDUFA goal date of September 27, 2020
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• |
Reported full year 2019 revenues and adjusted EBITDA that exceeded the top end of guidance range
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• |
Confirms full year 2020 revenue guidance and updates for improved earnings and reduced cash burn
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• |
Hosts investment community conference call at 8:00 am ET on March 12, 2020
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• |
At the constructive face-to-face meeting in February 2020 with the U.S. Food and Drug Administration (FDA) prior to filing Aquestive’s Investigational New Drug (IND) application for AQST-108, the FDA confirmed that the drug candidate
will be reviewed under the 505(b)(2) regulatory approval pathway, and that no additional studies will be necessary prior to opening the proposed IND application. Aquestive is currently preparing the IND application, which is expected
to be submitted in the second quarter 2020 and plans to commence PK clinical trials before year end.
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• |
Following the FDA’s acceptance of the New Drug Application (NDA) for Aquestive’s drug candidate, Libervant™ (diazepam) Buccal Film for the management of seizure clusters, the FDA has assigned a Prescription
Drug User Fee Act (PDUFA) goal date of September 27, 2020. Aquestive believes that Libervant will, if approved by the FDA, represent a “major contribution to patient care”, as compared to available treatment options, and further expand
patient choice as the first orally delivered diazepam-based product available to manage seizure clusters in epilepsy patients. See an explanation of the FDA’s determination of “major contribution to patient care” and its grant of
seven-year orphan drug exclusivity for a competing product in the section below in this press release entitled “Additional Information Regarding Orphan Drug Exclusivity”.
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• |
Sympazan® (clobazam), an oral film for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and launched as a precursor and complement to Libervant, continues to exhibit progress on key
performance metrics including prescriber growth, repeat prescribers, quarterly growth in retail shipments, and covered lives.
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• |
Total revenues of approximately $35 million to $45 million
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o |
Expected revenue from Suboxone® includes branded only, as authorized generic products were discontinued in 2019; branded Suboxone ended 2019 with a 48% film market share and is expected to continue to erode
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o |
Expected revenues from Sympazan® net sales, co-development programs, and license fees and royalties from licensed products
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o |
We did not include any Libervant revenues in our 2020 guidance.
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• |
Non-GAAP adjusted gross margins of approximately 70% to 75% on total revenues
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o |
Reflective of the anticipated higher profitability of Suboxone manufacturing revenues and expected greater mix of higher margin proprietary revenue
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• |
Non-GAAP adjusted EBITDA loss of approximately $45 million to $50 million
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o |
The Company expects to reduce its expenses and to improve adjusted EBITDA losses from previous guidance for 2020 by limiting its near-term focus to Libervant and AQST-108, and managing costs to reflect the declining revenue of
Suboxone and the level of contribution of Sympazan
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• |
Cash burn of approximately $45 million to $50 million after considering revised adjusted EBITDA loss guidance, interest, capital spending and working capital effects, but prior to any additional capital transactions
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• |
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
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• |
Limit dosages and durations to the minimum required.
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• |
Follow patients for signs and symptoms of respiratory depression and sedation.
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Three Months Ended
December 31,
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Year Ended
December 31,
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|||||||||||||||
2019
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2018
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2019
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2018
|
|||||||||||||
Revenues
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$
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16,419
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$
|
16,824
|
$
|
52,609
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$
|
67,430
|
||||||||
Costs and expenses:
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||||||||||||||||
Manufacture and supply
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6,792
|
4,787
|
20,361
|
20,988
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||||||||||||
Research and development
|
3,057
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5,683
|
20,574
|
23,112
|
||||||||||||
Selling, general and administrative
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16,474
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18,710
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64,342
|
72,269
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||||||||||||
Total costs and expenses
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26,323
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29,180
|
105,277
|
116,369
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||||||||||||
Loss from operations
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(9,904
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) |
(12,356
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) |
(52,668
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) |
(48,939
|
)
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||||||||
Other income/(expenses):
|
||||||||||||||||
Interest expense
|
(2,803
|
)
|
(1,902
|
)
|
(9,318
|
)
|
(7,711
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)
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||||||||
Interest income
|
71
|
314
|
636
|
552
|
||||||||||||
Loss on extinguishment of debt
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-
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-
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(4,896
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)
|
-
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|||||||||||
Change in fair value of warrant
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-
|
-
|
-
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(5,278
|
)
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|||||||||||
Loss before income taxes
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(12,636
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) |
(13,944
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) |
(66,246
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)
|
(61,376
|
) | ||||||||
Income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
$ |
(12,636
|
) | $ |
(13,944
|
) | $ |
(66,246
|
)
|
$ |
(61,376
|
) | ||||
Net loss per share - basic and diluted
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$
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(0.48
|
)
|
$
|
(0.56
|
)
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$
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(2.61
|
)
|
$
|
(2.96
|
)
|
||||
Weighted-average number of common shares outstanding - basic and diluted
|
26,435,840
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24,942,185
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25,356,098
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20,725,526
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Assets
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December 31,
2019
|
December 31,
2018
|
||||||
Current assets:
|
||||||||
Cash and cash equivalents
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$
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49,326
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$
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60,599
|
||||
Trade and other receivables, net
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13,130
|
6,481
|
||||||
Inventories, net
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2,859
|
5,441
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||||||
Prepaid expenses and other current assets
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2,999
|
1,680
|
||||||
Total current assets
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68,314
|
74,201
|
||||||
Property and equipment, net
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9,726
|
12,207
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||||||
Intangible assets, net and other assets
|
439
|
443
|
||||||
Total assets
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$
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78,479
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$
|
86,851
|
||||
Liabilities and stockholders’ deficit/equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
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$
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12,274
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$
|
20,436
|
||||
Accrued expenses
|
5,475
|
7,195
|
||||||
Deferred revenue, current
|
806
|
721
|
||||||
Loans payable, current
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-
|
4,600
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||||||
Total current liabilities
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18,555
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32,952
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||||||
Deferred revenue, net of current portion
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4,348
|
-
|
||||||
Loans payable, net
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60,338
|
42,603
|
||||||
Asset retirement obligations
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1,360
|
1,216
|
||||||
Total liabilities
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84,601
|
76,771
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||||||
Commitments and contingencies
|
||||||||
Stockholders’ (deficit)/equity:
|
||||||||
Common stock, $.001 par value. Authorized 250,000,000 shares; 33,562,885 and 24,957,309 shares issued and outstanding at December 31, 2019 and 2018, respecitively
|
34
|
25
|
||||||
Additional paid-in capital
|
124,318
|
71,431
|
||||||
Accumulated deficit
|
(130,474
|
)
|
(61,376
|
)
|
||||
Total stockholders’ (deficit)/equity
|
(6,122
|
)
|
10,080
|
|||||
Total liabilities and stockholders’ (deficit)/equity
|
$
|
78,479
|
$
|
86,851
|
Three Months Ended
December 31,
|
Year Ended
December 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Total costs and expenses
|
$
|
26,323
|
$
|
29,180
|
$
|
105,277
|
$
|
116,369
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based compensation expense
|
(1,873
|
)
|
(1,399
|
)
|
(7,071
|
)
|
(29,940
|
)
|
||||||||
Depreciation and amortization
|
(723
|
)
|
(760
|
)
|
(2,905
|
)
|
(3,236
|
)
|
||||||||
Adjusted costs and expenses
|
$
|
23,727
|
$
|
27,021
|
$
|
95,013
|
$
|
83,193
|
Three Months Ended
December 31,
|
Year Ended
December 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Manufacture and supply expense
|
$
|
6,792
|
$
|
4,787
|
$
|
20,361
|
$
|
20,988
|
||||||||
Gross margin on total revenue
|
59
|
%
|
72
|
%
|
61
|
%
|
69
|
%
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based compensation expense
|
(50
|
)
|
(37
|
)
|
(221
|
)
|
(414
|
)
|
||||||||
Depreciation and amortization
|
(585
|
)
|
(615
|
)
|
(2,350
|
)
|
(2,618
|
)
|
||||||||
Adjusted manufacture and supply expense
|
$
|
6,157
|
$
|
4,135
|
$
|
17,790
|
$
|
17,956
|
||||||||
Non-GAAP gross margin on total revenue
|
63
|
%
|
75
|
%
|
66
|
%
|
73
|
%
|
Three Months Ended
December 31,
|
Year Ended
December 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Research and development expense
|
$
|
3,057
|
$
|
5,683
|
$
|
20,574
|
$
|
23,112
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based compensation expense
|
(185
|
)
|
(205
|
)
|
(720
|
)
|
(2,583
|
)
|
||||||||
Depreciation and amortization
|
(65
|
)
|
(109
|
)
|
(265
|
)
|
(368
|
)
|
||||||||
Adjusted research and development expense
|
$
|
2,807
|
$
|
5,369
|
$
|
19,589
|
$
|
20,161
|
Three Months Ended
December 31,
|
Year Ended
December 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Selling, general and administrative expenses
|
$
|
16,474
|
$
|
18,710
|
$
|
64,342
|
$
|
72,269
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based compensation expense
|
(1,638
|
)
|
(1,157
|
)
|
(6,130
|
)
|
(26,943
|
)
|
||||||||
Depreciation and amortization
|
(73
|
)
|
(36
|
)
|
(290
|
)
|
(250
|
)
|
||||||||
Adjusted selling, general and administrative expenses
|
$
|
14,763
|
$
|
17,517
|
$
|
57,922
|
$
|
45,076
|
Three Months Ended
December 31,
|
Year Ended
December 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Net loss
|
$
|
(12,636
|
)
|
$
|
(13,944
|
)
|
$
|
(66,246
|
)
|
$
|
(61,376
|
)
|
||||
Share-based compensation
|
1,872
|
1,399
|
7,071
|
29,940
|
||||||||||||
Interest expense, net
|
2,732
|
1,588
|
8,682
|
7,159
|
||||||||||||
Loss on extinguishment of debt
|
-
|
-
|
4,896
|
-
|
||||||||||||
Income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Depreciation and amortization
|
723
|
760
|
2,905
|
3,236
|
||||||||||||
Change in fair value of warrant
|
-
|
-
|
-
|
5,278
|
||||||||||||
Adjusted EBITDA
|
$
|
(7,309
|
)
|
$
|
(10,197
|
)
|
$
|
(42,692
|
)
|
$
|
(15,763
|
)
|