☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
30 Technology Drive, Warren, NJ 07059
|
82-3827296
|
(State or other jurisdiction of Incorporation
or organization)
|
(908)-941-1900
|
(I.R.S. Employer Identification Number)
|
(Address, Zip Code and Telephone Number of Registrant’s Principal Executive Offices)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.001 per share
|
AQST
|
NASDAQ Global Market
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
Non-accelerated filer ☒
|
Smaller reporting company ☒
|
Emerging growth company ☒
|
Page No.
|
||
PART I – FINANCIAL INFORMATION
|
||
Item 1.
|
Financial Statements (Unaudited)
|
|
2
|
||
3
|
||
4
|
||
5
|
||
6
|
||
Item 2.
|
21 | |
Item 3.
|
34 | |
Item 4.
|
34 | |
PART II – OTHER INFORMATION
|
||
Item 1.
|
36 | |
Item 1A.
|
37 | |
Item 2.
|
37 | |
Item 3.
|
38 | |
Item 4.
|
38 | |
Item 5.
|
38 | |
Item 6.
|
38 | |
39 |
June 30,
2019
|
December 31,
2018
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
22,165
|
$
|
60,599
|
||||
Trade and other receivables, net
|
10,150
|
6,481
|
||||||
Inventories, net
|
4,647
|
5,441
|
||||||
Prepaid expenses and other current assets
|
2,102
|
1,680
|
||||||
Total current assets
|
39,064
|
74,201
|
||||||
Property and equipment, net
|
10,933
|
12,207
|
||||||
Intangible assets, net
|
178
|
204
|
||||||
Other assets
|
233
|
239
|
||||||
Total assets
|
$
|
50,408
|
$
|
86,851
|
||||
Liabilities and shareholders’ (deficit)/equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
23,479
|
$
|
27,631
|
||||
Deferred revenue, current
|
600
|
721
|
||||||
Loans payable, current
|
550
|
4,600
|
||||||
Total current liabilities
|
24,629
|
32,952
|
||||||
Loans payable, net
|
46,884
|
42,603
|
||||||
Deferred revenue, net of current portion
|
2,266
|
—
|
||||||
Asset retirement obligations
|
1,286
|
1,216
|
||||||
Total liabilities
|
75,065
|
76,771
|
||||||
Commitments and contingencies (note 17)
|
||||||||
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
|
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
|
|||||||||||||
Revenues
|
$
|
11,129
|
$
|
13,928
|
$
|
23,772
|
$
|
37,339
|
||||||||
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
|
33,668
|
34,154
|
41,213
|
||||||||||||
Total costs and expenses
|
29,817
|
46,635
|
55,534
|
64,717
|
||||||||||||
Loss from operations
|
(18,688
|
)
|
(32,707
|
)
|
(31,762
|
)
|
(27,378
|
)
|
||||||||
Other income/(expenses):
|
||||||||||||||||
Interest expense
|
(1,937
|
)
|
(1,927
|
)
|
(3,863
|
)
|
(3,876
|
)
|
||||||||
Interest income
|
153
|
-
|
427
|
22
|
||||||||||||
Change in fair value of warrant
|
-
|
(1,859
|
)
|
-
|
(1,162
|
)
|
||||||||||
Net loss before income taxes
|
(20,472
|
)
|
(36,493
|
)
|
(35,198
|
)
|
(32,394
|
)
|
||||||||
Income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
$
|
(20,472
|
)
|
$
|
(36,493
|
)
|
$
|
(35,198
|
)
|
$
|
(32,394
|
)
|
||||
Comprehensive loss
|
$
|
(20,472
|
)
|
$
|
(36,493
|
)
|
$
|
(35,198
|
)
|
$
|
(32,394
|
)
|
||||
Net loss per share - basic and diluted
|
$
|
(0.82
|
)
|
$
|
(1.90
|
)
|
$
|
(1.41
|
)
|
$
|
(1.89
|
)
|
||||
Weighted-average number of common shares outstanding - basic and diluted
|
24,980,861
|
19,188,624
|
24,972,280
|
17,144,492
|
Additional
|
Total
|
|||||||||||||||||||
Common Stock
|
Paid-in
|
Accumulated
|
Shareholders’
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Deficit
|
||||||||||||||||
For the periods ended June 30, 2018:
|
||||||||||||||||||||
Balance January 1, 2018*
|
5,000
|
$
|
-
|
$
|
(26,495
|
)
|
$
|
-
|
$
|
(26,495
|
)
|
|||||||||
Effect of stock split
|
15,072,647
|
15
|
(15
|
)
|
-
|
|||||||||||||||
Net income
|
-
|
-
|
-
|
4,099
|
4,099
|
|||||||||||||||
Balance, March 31, 2018
|
15,077,647
|
15
|
(26,510
|
)
|
4,099
|
(22,396
|
)
|
|||||||||||||
Common Stock issued to performance unit plan participants
|
4,922,353
|
5
|
19,929
|
-
|
19,934
|
|||||||||||||||
Share-based compensation
|
-
|
-
|
7
|
-
|
7
|
|||||||||||||||
Net loss
|
-
|
-
|
-
|
(36,493
|
)
|
(36,493
|
)
|
|||||||||||||
Balance, June 30, 2018
|
20,000,000
|
$
|
20
|
$
|
(6,574
|
)
|
$
|
(32,394
|
)
|
$
|
(38,948
|
)
|
For the periods ended June 30, 2019:
|
||||||||||||||||||||
Balance January 1, 2019
|
24,957,309
|
$
|
25
|
$
|
71,431
|
$
|
(61,376
|
)
|
$
|
10,080
|
||||||||||
Adoption of ASU 2014-09, ASU 2018-07 (note 3.C.)
|
-
|
-
|
20
|
(2,852
|
)
|
(2,832
|
)
|
|||||||||||||
Share-based compensation
|
17,830
|
-
|
1,422
|
-
|
1,422
|
|||||||||||||||
Net loss
|
-
|
-
|
-
|
(14,726
|
)
|
(14,726
|
)
|
|||||||||||||
Balance, March 31, 2019
|
24,975,139
|
25
|
72,873
|
(78,954
|
)
|
(6,056
|
)
|
|||||||||||||
Share-based compensation
|
16,128
|
-
|
1,739
|
-
|
1,739
|
|||||||||||||||
Shares issued under employee stock purchase plan
|
31,393
|
132
|
132
|
|||||||||||||||||
Net loss
|
-
|
-
|
-
|
(20,472
|
)
|
(20,472
|
)
|
|||||||||||||
Balance, June 30, 2019
|
25,022,660
|
$
|
25
|
$
|
74,744
|
$
|
(99,426
|
)
|
$
|
(24,657
|
)
|
Six Months Ended
June 30,
|
||||||||
2019
|
2018
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(35,198
|
)
|
$
|
(32,394
|
)
|
||
Adjustments to reconcile net loss to net cash (used for)/provided by operating activities:
|
||||||||
Depreciation and amortization
|
1,447
|
1,705
|
||||||
Change in fair value of warrant
|
—
|
1,162
|
||||||
Share-based compensation
|
3,330
|
27,305
|
||||||
Asset retirement obligation accretion
|
70
|
69
|
||||||
Amortization of intangible
|
26
|
25
|
||||||
Amortization of debt issuance costs and discounts
|
781
|
923
|
||||||
Non-cash interest expense
|
505
|
(16
|
)
|
|||||
Bad debt provision
|
30
|
31
|
||||||
Other, net
|
(15
|
)
|
—
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Trade receivables and other receivables
|
(3,684
|
)
|
(481
|
)
|
||||
Inventories, net
|
794
|
(334
|
)
|
|||||
Prepaid expenses and other current assets
|
(416
|
)
|
(179
|
)
|
||||
Accounts payable and accrued expenses
|
(1,829
|
)
|
3,593
|
|||||
Deferred revenue
|
(687
|
)
|
(113
|
)
|
||||
Net cash (used for)/provided by operating activities
|
(34,846
|
)
|
1,296
|
|||||
Cash flows from investing activities:
|
||||||||
Capital expenditures
|
(486
|
)
|
(886
|
)
|
||||
Net cash used for investing activities
|
(486
|
)
|
(886
|
)
|
||||
Cash flows used for financing activities:
|
||||||||
Proceeds from common stock issued under employee stock purchase plan
|
112
|
—
|
||||||
Debt repayment
|
(550
|
)
|
—
|
|||||
Payments for deferred financing costs
|
—
|
(1,528
|
)
|
|||||
Payments for taxes on share-based compensation
|
(2,664
|
)
|
(5,623
|
)
|
||||
Net cash used for financing activities
|
(3,102
|
)
|
(7,151
|
)
|
||||
Net decrease in cash and cash equivalents
|
(38,434
|
)
|
(6,741
|
)
|
||||
Cash and cash equivalents:
|
||||||||
Beginning of period
|
60,599
|
17,379
|
||||||
End of period
|
$
|
22,165
|
$
|
10,638
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Cash payments for interest
|
$
|
2,577
|
$
|
2,970
|
||||
Net (decrease)/increase in accrued capital expenditures
|
(313
|
)
|
125
|
|||||
Net increase in financing costs included in accounts payable and accrued expenses
|
150
|
-
|
||||||
Net increase in offering costs included in accounts payable and accrued expenses
|
-
|
1,694
|
||||||
Accrued withholding tax for share based compensation
|
-
|
1,741
|
Note 1. |
Corporate Organization and Company Overview
|
(i) |
increase the authorized number of shares of capital stock from 25,000 to 350,000,000 shares, and subsequently reduced that authorized total to 250,000,000,
|
(ii) |
authorize certain non-voting common stock for use in settlement of performance incentive obligations, and
|
(iii) |
effect a stock split of the Company’s common stock, par value $0.001 per share, such that each share be subdivided and reclassified into 37,212 shares of voting common stock, par value $0.001 per share. Subsequent to this split, and in
connection to pricing considerations related to the Company’s initial public offering (“IPO”), a reverse split was executed such that each 12.34 shares outstanding converted into one share of common stock, par value $0.001 per share.
|
Note 2. |
Basis of Presentation
|
Note 3. |
Summary of Significant Accounting Policies
|
Note 4. |
Risks and Uncertainties
|
Note 5. |
Revenues and Trade Receivables, Net
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Manufacture and supply revenue
|
$
|
8,915
|
$
|
8,684
|
$
|
15,584
|
$
|
20,244
|
||||||||
License and royalty revenue
|
424
|
4,532
|
5,046
|
14,032
|
||||||||||||
Co-development and research fees
|
1,019
|
712
|
1,789
|
3,063
|
||||||||||||
Proprietary product sales, net
|
771
|
-
|
1,353
|
-
|
||||||||||||
Total revenues
|
$
|
11,129
|
$
|
13,928
|
$
|
23,772
|
$
|
37,339
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
United States
|
$
|
10,267
|
$
|
13,380
|
$
|
22,661
|
$
|
36,577
|
||||||||
Ex-United States
|
862
|
548
|
1,111
|
762
|
||||||||||||
Total revenues
|
$
|
11,129
|
$
|
13,928
|
$
|
23,772
|
$
|
37,339
|
June 30,
2019
|
December 31,
2018
|
|||||||
Trade receivables
|
$
|
10,036
|
$
|
6,610
|
||||
Contract and other receivables
|
290
|
33
|
||||||
Less: allowance for bad debts
|
(88
|
)
|
(58
|
)
|
||||
Less: sales-related allowances
|
(88
|
)
|
(104
|
)
|
||||
Trade and other receivables, net
|
$
|
10,150
|
$
|
6,481
|
June 30,
2019
|
December 31,
2018
|
|||||||
Allowance for doubtful accounts at beginning of year
|
$
|
58
|
$
|
55
|
||||
Additions charged to bad debt expense
|
30
|
53
|
||||||
Write-downs charged against the allowance
|
-
|
(50
|
)
|
|||||
Allowance for doubtful accounts at end of the period
|
$
|
88
|
$
|
58
|
Total Sales Related
Allowances and Accruals
|
||||
Balance at December 31, 2018
|
$
|
585
|
||
Provision
|
847 |
|||
Payments / credits |
(535
|
)
|
||
Balance at June 30, 2019
|
$
|
897
|
Note 6. |
Material Agreements
|
Note 7.
|
Financial Instruments – Fair Value Measurements
|
• |
Level 1 — Observable quoted prices in active markets for identical assets or liabilities.
|
• |
Level 2 — Observable prices that are based on inputs not quoted on active markets but corroborated by market data.
|
• |
Level 3 — Unobservable inputs that are supported by little or no market activity, such as pricing models, discounted cash flow methodologies and similar techniques.
|
Note 8. |
Inventories, Net
|
June 30,
2019
|
December 31,
2018
|
|||||||
Raw material
|
$
|
1,247
|
$
|
1,283
|
||||
Packaging material
|
2,366
|
2,975
|
||||||
Finished goods
|
1,034
|
1,183
|
||||||
Total inventory, net
|
$
|
4,647
|
$
|
5,441
|
Note 9. |
Property and Equipment, Net
|
Useful
Lives
|
June 30,
2019
|
December 31,
2018
|
||||||||
Machinery
|
3-15 yrs
|
$
|
20,905
|
$
|
20,681
|
|||||
Furniture and fixtures
|
3-15 yrs
|
1,150
|
1,150
|
|||||||
Leasehold improvements
|
(a)
|
21,333
|
21,333
|
|||||||
Computer, network equipment and software
|
3-7 yrs
|
2,657
|
2,579
|
|||||||
Construction in progress
|
1,526
|
1,655
|
||||||||
47,571
|
47,398
|
|||||||||
Less: accumulated depreciation and amortization
|
(36,638
|
)
|
(35,191
|
)
|
||||||
Total property and equipment, net
|
$
|
10,933
|
$
|
12,207
|
(a) |
Leasehold improvements are amortized over the shorter of the lease term or their estimated useful lives.
|
Note 10. |
Intangible Assets
|
June 30,
2019
|
December 31,
2018
|
|||||||
Purchased technology-based intangible
|
$
|
2,358
|
$
|
2,358
|
||||
Purchased patent
|
509
|
509
|
||||||
2,867
|
2,867
|
|||||||
Less: accumulated amortization
|
(2,689
|
)
|
(2,663
|
)
|
||||
Total intangible assets, net
|
$
|
178
|
$
|
204
|
Note 11. |
Accounts Payable and Accrued Expenses
|
June 30,
2019
|
December 31,
2018
|
|||||||
Accounts payable
|
$
|
20,034
|
$
|
20,436
|
||||
Accrued compensation
|
2,282
|
3,604
|
||||||
Accrued withholding tax for share-based compensation
|
-
|
2,515
|
||||||
Real estate and personal property taxes
|
176
|
388
|
||||||
Accrued distribution expenses
|
809
|
481
|
||||||
Other
|
178
|
207
|
||||||
Total accounts payable and accrued expenses
|
$
|
23,479
|
$
|
27,631
|
Note 12. |
Loans Payable
|
Note 13. |
Warrants
|
Note 14. |
Net Loss Per Share
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Numerator:
|
||||||||||||||||
Net loss
|
$
|
(20,472
|
)
|
$
|
(36,493
|
)
|
$
|
(35,198
|
)
|
$
|
(32,394
|
)
|
||||
Denominator:
|
||||||||||||||||
Weighted-average number of common shares – basic
|
24,980,861
|
19,188,624
|
24,972,280
|
17,144,492
|
||||||||||||
Loss per common share - basic
|
$
|
(0.82
|
)
|
$
|
(1.90
|
)
|
$
|
(1.41
|
)
|
$
|
(1.89
|
)
|
Note 15. |
Share-Based Compensation
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
Expense classification:
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Manufacture and supply
|
$
|
72
|
$
|
345
|
$
|
116
|
$
|
345
|
||||||||
Research and development
|
140
|
2,186
|
348
|
2,186
|
||||||||||||
Selling, general and administrative
|
1,598
|
24,774
|
2,866
|
24,774
|
||||||||||||
Total share-based compensation expenses
|
$
|
1,810
|
$
|
27,305
|
$
|
3,330
|
$
|
27,305
|
||||||||
Share-based compensation from:
|
||||||||||||||||
Restricted stock units
|
$
|
467
|
$
|
—
|
$
|
930
|
$
|
—
|
||||||||
Stock options
|
1,323
|
7
|
2,380
|
7
|
||||||||||||
Non-voting common shares
|
—
|
27,298
|
—
|
27,298
|
||||||||||||
Employee stock purchase plan
|
20
|
—
|
20
|
—
|
||||||||||||
Total share-based compensation expenses
|
$
|
1,810
|
$
|
27,305
|
$
|
3,330
|
$
|
27,305
|
Restricted stock units:
|
Number of
Units
|
Weighted Average
Grant Date Fair
Value
|
||||||
(in thousands)
|
||||||||
Unvested at December 31, 2018
|
205
|
$
|
14.77
|
|||||
Granted
|
—
|
—
|
||||||
Vested
|
(59
|
)
|
15.03
|
|||||
Forfeited
|
(3
|
)
|
13.00
|
|||||
Unvested at June 30, 2019
|
143
|
$
|
14.70
|
|||||
Grant date fair value of shares vested during the period
|
$
|
896
|
||||||
Unrecognized compensation costs of RSU awards at June 30, 2019
|
$
|
1,881
|
Stock options:
|
Number of
Options
|
Weighted Average
Exercise Price
|
||||||
(in thousands)
|
||||||||
Outstanding at December 31, 2018
|
1,033
|
$
|
14.72
|
|||||
Granted
|
975
|
7.51
|
||||||
Forfeited
|
(25
|
)
|
7.77
|
|||||
Exercised, expired
|
—
|
—
|
||||||
Outstanding at June 30, 2019
|
1,983
|
$
|
11.26
|
|||||
Vested or expected to vest at June 30, 2019
|
1,868
|
$
|
11.12
|
|||||
Exercisable at June 30, 2019
|
223
|
$
|
14.32
|
Expected dividend yield
|
0
|
%
|
||
Expected volatility
|
85 - 95
|
%
|
||
Expected term (years)
|
5.5 - 6.1
|
|||
Risk-free interest rate
|
1.9 - 2.6
|
%
|
Note 16. |
Income Taxes
|
Note 17. |
Commitments and Contingencies
|
• |
Mylan and Sandoz settled without a trial. Sandoz withdrew all challenges and became the distributor of the authorized generic.
|
• |
All cases against Par were resolved pursuant to a May 2018 settlement agreement between the Company, Indivior, and Par and certain of its affiliates.
|
• |
Actavis was found to infringe the ‘514 patent and cannot enter the market until the expiration of the patent in 2024, and the Federal Circuit affirmed that ruling on July 12, 2019.
|
• |
DRL and Alvogen were found not to infringe under a different claim construction analysis, and the Federal Circuit affirmed that ruling on July 12,
2019. Teva has agreed to be bound by all DRL adjudications.
|
•
|
The first, a declaratory judgment action brought by BDSI against Indivior and Aquestive, seeks declarations of invalidity and non-infringement of U.S. Patents Nos. 7,897,080, or the ’080 patent, 8,652,378, or
the ’378 patent, and 8,475,832, or the ’832 patent. This case is stayed pending final resolution of the above-mentioned appeals on related patents.
|
•
|
The second was filed by us and Indivior related to BDSI’s infringing Bunavail product, and alleges infringement of the Company’s patent, U.S. Patent No. 8,765,167, or the ’167 patent, and seeks an injunction
and potential monetary damages. Shortly after the case was filed, BDSI filed four IPRs challenging the asserted ’167 patent. On March 24, 2016, the Patent Trial and Appeal Board, or the PTAB, issued a final written decision finding that
all claims of the ’167 patent were valid. The case was stayed in May 2016 pending the final determination of the appeals on those decisions. Following the PTAB’s February 7, 2019 decisions on remand denying institution, Aquestive and
Indivior submitted a notice to the Court on February 15, 2019 notifying the Court that the stay should be lifted as a result of the PTAB’s decisions. We are awaiting further action from the Court.
|
• |
On January 13, 2017, the Company also sued BDSI asserting infringement of the ’167 patent by BDSI’s Belbuca product and seeking an injunction and potential monetary damages. Following the PTAB’s February 7, 2019 decisions on remand
denying institution, the Company submitted a notice to the Court on February 15, 2019 notifying the Court that BDSI’s motion to stay should be denied as moot. BDSI also sent a letter to the Court on February 13, 2019 indicating its
intent to appeal the PTAB’s decisions. The parties are awaiting further action from the Court. BDSI appealed the PTAB’s remand decisions to the Federal Circuit, and on March 20, 2019, we moved to dismiss the appeal for lack of
jurisdiction.
|
Note 18. |
Subsequent Event
|
• |
Libervant™, a buccal soluble film formulation of diazepam used as a rescue therapy for breakthrough epileptic seizures and an adjunctive therapy for use in recurrent convulsive seizures, for which a pre-NDA meeting was held in
December 2018 with the FDA. The meeting resulted in a plan to complete a small single-dose crossover study comparing Libervant to the reference listed drug, Diastat®. This study was initiated in the first quarter of 2019, and
enrollment into the study was completed in May 2019. The Company also began a rolling NDA submission process during the second quarter of 2019. Subsequent to the close of the period, the Company completed the crossover study and is
evaluating the data generated.
|
• |
Exservan™, an oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDA in the first quarter of 2019; the PDUFA goal date for FDA approval is November 30,
2019.
|
• |
AQST-108, a sublingual soluble film formulation for the treatment of anaphylaxis and severe allergic reactions, which is intended to provide an adjunct and or alternative to injection treatments such as EpiPen. After the Company’s
first human proof of concept trials, a re-formulated and more advanced prototype has been developed, for which we began additional phase 1 proof of concept trials early in the second quarter of 2019; and
|
• |
AQST-305, a sublingual soluble film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors. As a result of early stage clinical proof of concept studies, re-formulation work is currently underway.
|
• |
fund commercialization investments for Sympazan (launched in December 2018) and, subject to FDA approval, Libervant, our epilepsy products;
|
• |
continue clinical development of our complex molecules, AQST-108 and AQST-305;
|
•
|
identify and evaluate new pipeline candidates in CNS diseases and other indications; and
|
• |
fund working capital requirements and expected capital expenditures as a result of the launch of proprietary products and related growth.
|
• |
employee-related expenses;
|
• |
external research and development expenses incurred under arrangements with third parties;
|
• |
the cost of acquiring, developing and manufacturing clinical study materials; and
|
• |
costs associated with preclinical and clinical activities and regulatory operations.
|
Three Months Ended
June 30,
|
Change
|
|||||||||||||||
(In thousands, except %)
|
2019
|
2018
|
$
|
%
|
||||||||||||
Manufacture and supply revenue
|
$
|
8,915
|
$
|
8,684
|
$
|
231
|
3
|
%
|
||||||||
License and royalty revenue
|
424
|
4,532
|
(4,108
|
)
|
(91
|
%)
|
||||||||||
Co-development and research fees
|
1,019
|
712
|
307
|
43
|
%
|
|||||||||||
Proprietary product sales, net
|
771
|
-
|
771
|
100
|
%
|
|||||||||||
Total revenues
|
$
|
11,129
|
$
|
13,928
|
$
|
(2,799
|
)
|
(20
|
%)
|
Three Months Ended
June 30,
|
Change
|
|||||||||||||||
(In thousands, except %)
|
2019
|
2018
|
$
|
%
|
||||||||||||
Manufacture and supply
|
$
|
5,420
|
$
|
4,973
|
$
|
447
|
9
|
%
|
||||||||
Research and development
|
8,151
|
7,994
|
157
|
2
|
%
|
|||||||||||
Selling, general and administrative
|
16,246
|
33,668
|
(17,422
|
)
|
(52
|
)%
|
||||||||||
Interest expense
|
1,937
|
1,927
|
10
|
1
|
%
|
|||||||||||
Interest income
|
(153
|
)
|
-
|
153
|
NM
|
|||||||||||
Other
|
-
|
1,859
|
(1,859
|
)
|
NM
|
Six Months Ended
June 30,
|
Change
|
|||||||||||||||
(In thousands, except %)
|
2019
|
2018
|
$
|
%
|
||||||||||||
Manufacture and supply revenue
|
$
|
15,584
|
$
|
20,244
|
$
|
(4,660
|
)
|
(23
|
%)
|
|||||||
License and royalty revenue
|
5,046
|
14,032
|
(8,986
|
)
|
(64
|
%)
|
||||||||||
Co-development and research fees
|
1,789
|
3,063
|
(1,274
|
)
|
(42
|
%)
|
||||||||||
Proprietary product sales, net
|
1,353
|
-
|
1,353
|
100
|
%
|
|||||||||||
Total revenues
|
$
|
23,772
|
$
|
37,339
|
$
|
(13,567
|
)
|
(36
|
%)
|
Six Months Ended
June 30,
|
Change
|
|||||||||||||||
(In thousands, except %)
|
2019
|
2018
|
$
|
%
|
||||||||||||
Manufacture and supply
|
$
|
8,926
|
$
|
10,609
|
$
|
(1,683
|
)
|
(16
|
)%
|
|||||||
Research and development
|
12,454
|
12,895
|
(441
|
)
|
(3
|
)%
|
||||||||||
Selling, general and administrative
|
34,154
|
41,213
|
(7,059
|
)
|
(17
|
)%
|
||||||||||
Interest expense
|
3,863
|
3,876
|
(13
|
)
|
0
|
%
|
||||||||||
Interest income
|
(427
|
)
|
(22
|
)
|
405
|
NM
|
||||||||||
Other
|
-
|
1,162
|
(1,162
|
)
|
NM
|
(In thousands)
|
2019
|
2018
|
||||||
Net cash (used for) provided by operating activities
|
$
|
(34,846
|
)
|
$
|
1,296
|
|||
Net cash (used for) investing activities
|
(486
|
)
|
(886
|
)
|
||||
Net cash (used for) financing activities
|
(3,102
|
)
|
(7,151
|
)
|
||||
Net decrease in cash and cash equivalents
|
$
|
(38,434
|
)
|
$
|
(6,741
|
)
|
• |
continued revenue from our proprietary and licensed products at planned levels;
|
• |
cost and expense reductions consistent with our anticipated revenues, and continuing review of our cost structure;
|
• |
our ability to issue on or before March 31, 2021, and available purchasers of, additional senior secured notes in an aggregate amount up to $30,000 principal amount under the indenture for our 12.5% Senior Secured Notes due 2025,
based on satisfying certain conditions including approval of our Libervant proprietary product, and approval of the first reopener by a majority of the holders of the Senior Secured Notes, (see “12.5% Senior Secured Notes” above);
|
• |
potential monetization of royalty streams or other license or proprietary rights for our product Apomorphine at anticipated levels, which cannot be assured (and which are subject to conditions and requirements under the indenture for
our new 12.5% Senior Secured Notes including note repurchase obligations at 112.500% of principal amount of such repurchased notes and accrued and unpaid interest thereon, at the option of the holders) (see “12.5% Senior Secured Notes”
above);
|
• |
continued funding of our commercialization costs for Sympazan, our first proprietary product launched in December 2018, and continued funding of our development and commercialization of CNS product Libervant, and our other
proprietary product candidates;
|
• |
the infrastructure and administrative costs to support being a public company;
|
• |
continued compliance with all covenants under our 12.5% Senior Secured Notes; and
|
• |
absence of significant unforeseen cash requirements.
|
• |
Mylan and Sandoz settled without a trial. Sandoz withdrew all challenges and became the distributor of the authorized generic.
|
• |
All cases against Par were resolved pursuant to a May 2018 settlement agreement between us, Indivior, and Par and certain of its affiliates.
|
• |
Actavis was found to infringe the ‘514 patent and cannot enter the market until the expiration of the patent in 2024, and the Federal Circuit affirmed that ruling on July 12, 2019.
|
• |
DRL and Alvogen were found not to infringe under a different claim construction analysis, and the Federal Circuit affirmed that ruling on July 12,
2019. Teva has agreed to be bound by all DRL adjudications.
|
• |
The first, a declaratory judgment action brought by BDSI against Indivior and Aquestive, seeks declarations of invalidity and non-infringement of U.S. Patents Nos. 7,897,080, or the ’080 patent, 8,652,378, or the ’378 patent, and
8,475,832, or the ’832 patent. This case is stayed pending final resolution of the above-mentioned appeals on related patents.
|
• |
The second was filed by us and Indivior related to BDSI’s infringing Bunavail product, and alleges infringement of our patent, U.S. Patent No. 8,765,167, or the ’167 patent, and seeks an injunction and potential monetary damages.
Shortly after the case was filed, BDSI filed four IPRs challenging the asserted ’167 patent. On March 24, 2016, the Patent Trial and Appeal Board, or the PTAB, issued a final written decision finding that all claims of the ’167 patent
were valid. The case was stayed in May 2016 pending the final determination of the appeals on those decisions. Following the PTAB’s February 7, 2019 decisions on remand denying institution, we and Indivior submitted a notice to the
Court on February 15, 2019 notifying the Court that the stay should be lifted as a result of the PTAB’s decisions. We are awaiting further action from the Court.
|
• |
On January 13, 2017, we also sued BDSI asserting infringement of the ’167 patent by BDSI’s Belbuca product and seeking an injunction and potential monetary damages. Following the PTAB’s February 7, 2019 decisions on remand denying
institution, the Company submitted a notice to the Court on February 15, 2019 notifying the Court that BDSI’s motion to stay should be denied as moot. BDSI also sent a letter to the Court on February 13, 2019 indicating its intent to
appeal the PTAB’s decisions. The parties are awaiting further action from the Court. BDSI appealed the PTAB’s remand decisions to the Federal Circuit, and on March 20, 2019, we moved to dismiss the appeal for lack of jurisdiction.
|
Number
|
Description
|
|
Indenture Dated as of July 15, 2019, among Aquestive Therapeutics, Inc, as Issuer, any Guarantor that becomes party thereto and U.S. Bank National Association, as Trustee and Collateral Agent, (incorporated by reference to Exhibit 4.1 to
the Current Report on Form 8-K filed by Aquestive Therapeutics, Inc. on July 16, 2019).
|
||
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed by Aquestive Therapeutics, Inc. in July 16, 2019).
|
||
Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Aquestive Therapeutics, Inc. in July 16, 2019).
|
||
Collateral Agreement dated as of July 15, 2019, among Aquestive Therapeutics, Inc., as Issuer, the Other Grantors for time to time party thereto, U.S. Bank National Association, as Trustee, and U.S. Bank National Association, as
Collateral Agent (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed by Aquestive Therapeutics, Inc. on July 16, 2019).
|
||
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a), as amended, under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
|
||
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a), as amended, under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
|
||
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
||
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
||
101.INS
|
XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document.
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
Aquestive Therapeutics, Inc.
(REGISTRANT)
|
||
Date:
|
August 6, 2019
|
/s/ Keith J. Kendall
|
Keith J. Kendall
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
||
Date:
|
August 6, 2019
|
/s/ John T. Maxwell
|
John T. Maxwell
|
||
Chief Financial Officer
|
||
(Principal Financial Officer)
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Aquestive Therapeutics, Inc.;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made,
not misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, consolidated results of operations and consolidated
cash flows of the registrant as of, and for, the periods presented in this report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial
reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or
persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ KEITH J. KENDALL
|
|
Keith J. Kendall
|
|
Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Aquestive Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made,
not misleading with respect to the period covered by this annual report;
|
3.
|
Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, consolidated results of operations and consolidated
cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial
reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors
(or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ JOHN T. MAXWELL
|
|
John T. Maxwell
|
|
Chief Financial Officer
(Principal Financial Officer)
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2019, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of
the Exchange Act; and
|
2.
|
The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Quarterly Report and the results of operations of the Company
for the period covered by the Quarterly Report.
|
/s/ KEITH J. KENDALL
|
|
Keith J. Kendall
|
|
Chief Executive Officer
(Principal Executive Officer)
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2019, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of
the Exchange Act; and
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2.
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The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Quarterly Report and the results of operations of the Company
for the period covered by the Quarterly Report.
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/s/ JOHN T. MAXWELL
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John T. Maxwell
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Chief Financial Officer
(Principal Financial Officer)
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