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 7.01 |
Other Events.
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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 August 6, 2019, announcing financial results for the three and six months ended June 30, 2019 and 2018, respectively.
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Press Release, dated August 6, 2019, announcing topline results from LibervantTM (Diazepam) Buccal Film Single Dose Crossover Study.
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Dated: August 6, 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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• |
Reported positive topline data from single dose crossover pharmacokinetic (PK) trial for Libervant™ (diazepam) Buccal Film and expects to complete its rolling New Drug Application (NDA) submission in fourth
quarter 2019
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• |
Reported a 250% increase in Sympazan® shipments compared to the end of the first quarter (Q1)
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• |
Completed debt refinancing in July 2019, with a $100 million total facility that provided $70 million at closing and an opportunity for up to an additional $30 million subject to certain conditions
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• |
Raises full year guidance for Suboxone-related manufacturing revenue
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• |
Hosts investment community conference call at 8:00 a.m. ET on August 7, 2019
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• |
The Company reported positive topline data from the single dose crossover study, which compared the pharmacokinetic responses in a common set of patients receiving a dose of LibervantTM (diazepam) Buccal Film and a dose of diazepam rectal gel. Preliminary analyses show that the overall diazepam exposure achieved from the buccal film was the
same as for gel based on the patient dosing algorithm and there was no difference between buccal film and gel in the effect of enzyme induction from taking concurrent anti-epileptic medications. Additionally, there were no instances of
low or non-responders observed after Libervant administration, while over 10% of those same patients failed to achieve adequate exposure following gel administration.
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• |
The rolling NDA submission for Libervant commenced in the second quarter 2019 and we expect it to be completed in in the fourth quarter 2019. Libervant has the potential to be the first oral therapy
approved by the U.S. Food and Drug Administration (FDA) for the management of seizure clusters or breakthrough seizures in the population of 1.2 million refractory epilepsy patients.
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• |
The launch of Sympazan® (clobazam) Oral Film for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older, with the potential we believe has the potential to
reach $65 million in peak net revenue within 5 years and driving market understanding about the value of Aquestive’s PharmFilm® technology. Sympazan shipment volume has grown over 250% since the end of the first quarter and the
prescribing base has grown over 125%, with over 80% of prescribers writing multiple scripts.
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• |
An optimized product formulation of AQST-108, a sublingual film formulation of epinephrine for the treatment of anaphylaxis and severe allergic reactions, is being evaluated in a Phase I Proof of Concept
study. Data from this trial is expected in late third quarter 2019.
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• |
Suboxone® and the authorized generic buprenorphine-naloxone film continue to retain approximately 75% of the market for film treatments as of July 2019, despite the at risk launches of several generic
products in the U.S. Aquestive has a strong order book through the first ten months of 2019, based on the slow erosion of brand market share, strong uptake of the authorized generic, and trusted product quality.
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• |
Total revenues of $38 million to $45 million, including Suboxone and Sandoz authorized generic manufacturing revenue of $29 million to $32 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 $50 million to $52 million; and
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• |
Cash burn of approximately $60 to $65 million after considering non-GAAP Adjusted EBITDA, net interest expense and principal paid on debt prior to refinancing.
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• |
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
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• |
Limit dosages and durations to the minimum required.
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• |
Follow patients for signs and symptoms of respiratory depression and sedation.
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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|||||||||||||||
2019
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2018
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2019
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2018
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|||||||||||||
Revenues
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$
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11,129
|
$
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13,928
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$
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23,772
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$
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37,339
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||||||||
Costs and Expenses:
|
||||||||||||||||
Manufacture and supply
|
5,420
|
4,973
|
8,926
|
10,609
|
||||||||||||
Research and development
|
8,151
|
7,994
|
12,454
|
12,895
|
||||||||||||
Selling, general and administrative
|
16,246
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33,668
|
34,154
|
41,213
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||||||||||||
Total costs and expenses
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29,817
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46,635
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55,534
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64,717
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||||||||||||
Loss from operations
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(18,688
|
)
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(32,707
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)
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(31,762
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)
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(27,378
|
)
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||||||||
Other income/(expenses):
|
||||||||||||||||
Interest expense
|
(1,937
|
)
|
(1,927
|
)
|
(3,863
|
)
|
(3,876
|
)
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||||||||
Interest income
|
153
|
-
|
427
|
22
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||||||||||||
Change in fair value of warrant
|
-
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(1,859
|
)
|
-
|
(1,162
|
)
|
||||||||||
Net loss before income taxes
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(20,472
|
)
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(36,493
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)
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(35,198
|
)
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(32,394
|
)
|
||||||||
Income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
(20,472
|
)
|
(36,493
|
)
|
(35,198
|
)
|
(32,394
|
)
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||||||||
Comprehensive loss
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$
|
(20,472
|
)
|
$
|
(36,493
|
)
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$
|
(35,198
|
)
|
$
|
(32,394
|
)
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||||
Net loss per share - basic and diluted
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$
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(0.82
|
)
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$
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(1.90
|
)
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$
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(1.41
|
)
|
$
|
(1.89
|
)
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||||
Weighted-average number of common shares outstanding - basic and diluted
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24,980,861
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19,188,624
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24,972,280
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17,144,492
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June 30,
2019
|
December 31,
2018
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|||||||
Assets
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||||||||
Current assets:
|
||||||||
Cash and cash equivalents
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$
|
22,165
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$
|
60,599
|
||||
Trade and other receivables, net
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10,150
|
6,481
|
||||||
Inventories, net
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4,647
|
5,441
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||||||
Prepaid expenses and other current assets
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2,102
|
1,680
|
||||||
Total current assets
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39,064
|
74,201
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||||||
Property and equipment, net
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10,933
|
12,207
|
||||||
Intangible assets, net
|
178
|
204
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||||||
Other assets
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233
|
239
|
||||||
Total assets
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$
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50,408
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$
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86,851
|
||||
Liabilities and shareholders' (deficit)/equity
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||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
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$
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23,479
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$
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27,631
|
||||
Deferred revenue, current
|
600
|
721
|
||||||
Loans payable, current
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550
|
4,600
|
||||||
Total current liabilities
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24,629
|
32,952
|
||||||
Loans payable, net
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46,884
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42,603
|
||||||
Deferred revenue, net of current portion
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2,266
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-
|
||||||
Asset retirement obligations
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1,286
|
1,216
|
||||||
Total liabilities
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75,065
|
76,771
|
||||||
Commitments and contingencies
|
||||||||
Shareholders’ (deficit)/equity:
|
||||||||
Common stock, $.001 par value. Authorized 250,000,000 shares; 25,022,660 and 24,957,309 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
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25
|
25
|
||||||
Additional paid-in capital
|
74,744
|
71,431
|
||||||
Accumulated deficit
|
(99,426
|
)
|
(61,376
|
)
|
||||
Total shareholders' (deficit)/equity
|
(24,657
|
)
|
10,080
|
|||||
Total liabilities and shareholders' (deficit) /equity
|
$
|
50,408
|
$
|
86,851
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Total Costs and Expenses
|
$
|
29,817
|
$
|
46,635
|
$
|
55,534
|
$
|
64,717
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(1,810
|
)
|
(27,305
|
)
|
(3,330
|
)
|
(27,305
|
)
|
||||||||
Depreciation and Amortization
|
(724
|
)
|
(777
|
)
|
(1,473
|
)
|
(1,730
|
)
|
||||||||
Adjusted Costs and Expenses
|
$
|
27,283
|
$
|
18,553
|
$
|
50,731
|
$
|
35,682
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Manufacture and Supply Expense
|
$
|
5,420
|
$
|
4,973
|
$
|
8,926
|
$
|
10,609
|
||||||||
Gross Margin on total revenue
|
51
|
%
|
64
|
%
|
62
|
%
|
72
|
%
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(72
|
)
|
(345
|
)
|
(116
|
)
|
(345
|
)
|
||||||||
Depreciation and Amortization
|
(586
|
)
|
(629
|
)
|
(1,193
|
)
|
(1,401
|
)
|
||||||||
Adjusted Manufacture and Supply Expense
|
$
|
4,762
|
$
|
3,999
|
$
|
7,617
|
$
|
8,863
|
||||||||
Non-GAAP Gross Margin on total revenue
|
57
|
%
|
71
|
%
|
68
|
%
|
76
|
%
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Research and Development Expense
|
$
|
8,151
|
$
|
7,994
|
$
|
12,454
|
$
|
12,895
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(140
|
)
|
(2,186
|
)
|
(348
|
)
|
(2,186
|
)
|
||||||||
Depreciation and Amortization
|
(60
|
)
|
(64
|
)
|
(121
|
)
|
(142
|
)
|
||||||||
Adjusted Research and Development Expense
|
$
|
7,951
|
$
|
5,744
|
$
|
11,985
|
$
|
10,567
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Selling, General and Administrative Expenses
|
$
|
16,246
|
$
|
33,668
|
$
|
34,154
|
$
|
41,213
|
||||||||
Non-GAAP adjustments:
|
||||||||||||||||
Share-based Compensation Expense
|
(1,598
|
)
|
(24,774
|
)
|
(2,866
|
)
|
(24,774
|
)
|
||||||||
Depreciation and Amortization
|
(78
|
)
|
(84
|
)
|
(159
|
)
|
(187
|
)
|
||||||||
Adjusted Selling, General and Administrative Expenses
|
$
|
14,570
|
$
|
8,810
|
$
|
31,129
|
$
|
16,252
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Net loss
|
$
|
(20,472
|
)
|
$
|
(36,493
|
)
|
$
|
(35,198
|
)
|
$
|
(32,394
|
)
|
||||
Share-based Compensation Expense
|
1,810
|
27,305
|
3,330
|
27,305
|
||||||||||||
Interest Expense
|
1,937
|
1,927
|
3,863
|
3,876
|
||||||||||||
Interest Income
|
(153
|
)
|
-
|
(427
|
)
|
(22
|
)
|
|||||||||
Depreciation and Amortization
|
724
|
777
|
1,473
|
1,730
|
||||||||||||
Income Taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Change in Fair Value of Warrant
|
-
|
1,859
|
-
|
1,162
|
||||||||||||
Adjusted EBITDA
|
$
|
(16,154
|
)
|
$
|
(4,625
|
)
|
$
|
(26,959
|
)
|
$
|
1,657
|
• |
The study confirms the dosing algorithm developed for Libervant (diazepam) buccal film, a potentially first in class oral treatment for breakthrough or cluster seizures
|
• |
Libervant adult rolling New Drug Application (NDA) submission expected to be completed in the fourth quarter of 2019
|
• |
Diazepam exposure following the buccal film was comparable to the rectal gel as assessed by maximal plasma concentration (Cmax ratio of buccal film to rectal gel = 103%; 90% CI = 76%-141%). Across the four weight classes,
buccal film demonstrated more consistent Cmax values than was observed in this study for rectal gel.
|
• |
The bioavailability of diazepam administered as the buccal film, assessed by AUC, was the same or higher than rectal gel for the study population overall and also within each of the four weight categories. This finding suggests that
any effect of enzyme induction from concomitant medications acted with equal effect on the film and the gel.
|
• |
The Tmax of diazepam film administration in patients under fed conditions (moderate fat) was comparable to the results from previous studies of healthy volunteers who were under fasting conditions (Tmax ~1 hour).
|