UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, ~~2019~~2020

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _____ to _____

Commission File Number: 001-38599

Aquestive Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	30 Technology Drive, Warren, NJ 07059	82-3827296
(State or other jurisdiction of Incorporation or organization)	(908)~~-941-1900~~ 941-1900	(I.R.S. Employer Identification Number)
~~(Address, Zip Code and Telephone Number of Registrant’s Principal Executive Offices)~~

(Address, Zip Code and Telephone Number of Registrant’s Principal Executive Offices)

Securities registered pursuant to Section 12(b) of the Act:

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

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

The number of outstanding shares of the registrant’s common stock, par value of $0.001 per share, as of the close of business on ~~August 2, 2019~~July 31, 2020 was ~~25,026,593.~~33,619,796

AQUESTIVE THERAPEUTICS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED JUNE 30, ~~2019~~2020

TABLE OF CONTENTS

		Page No.
PART I – FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)
	Condensed Consolidated Balance Sheets as of June 30, ~~2019~~2020 and December 31, ~~2018~~2019	23
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the ~~three~~three- and six-month periods ended June 30, ~~2019~~2020 and ~~2018~~2019	34
	Condensed Consolidated Statements of Changes in Stockholders’ Deficit for the ~~three~~three- and six-month periods ended June 30, ~~2019~~2020 and ~~2018~~2019	45
	Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, ~~2019~~2020 and ~~2018~~2019	56
	Notes to Unaudited Condensed Consolidated Financial Statements	67
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2124
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	3440
Item 4.	Controls and Procedures	3440

PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	3641
Item 1A.	Risk Factors	3743
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3744
Item 3.	Defaults Upon Senior Securities	3844
Item 4.	Mine Safety Disclosures	3844
Item 5.	Other Information	3844
Item 6.	Exhibits	3845

SIGNATURES		3946

Table of Contents

PART I – FINANCIAL INFORMATION

Item 1.

FINANCIAL STATEMENTS (Unaudited)

AQUESTIVE THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

	June 30, 2019			December 31, 2018			June 30, 2020			December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	22,165		$	60,599		$	25,422		$	49,326
Trade and other receivables, net		10,150			6,481			12,891			13,130
Inventories, net		4,647			5,441			3,173			2,859
Prepaid expenses and other current assets		2,102			1,680			2,423			2,999
Total current assets		39,064			74,201			43,909			68,314
Property and equipment, net		10,933			12,207			8,457			9,726
Intangible assets, net		178			204
Other assets		233			239
Right-of-use assets, net								3,764			—
Intangible assets, net and other assets								7,416			439
Total assets	$	50,408		$	86,851		$	63,546		$	78,479

Liabilities and shareholders’ (deficit)/equity
Liabilities and stockholders’ deficit
Current liabilities:
Accounts payable and accrued expenses	$	23,479		$	27,631		$	13,390		$	17,749
Lease liabilities, current								689			—
Deferred revenue, current		600			721			803			806
Loans payable, current		550			4,600
Total current liabilities		24,629			32,952			14,882			18,555
Loans payable, net		46,884			42,603			61,505			60,338
Lease liabilities								3,240			—
Deferred revenue, net of current portion		2,266			—			3,867			4,348
Asset retirement obligations		1,286			1,216			1,440			1,360
Total liabilities		75,065			76,771			84,934			84,601
Commitments and contingencies (note 17)
Contingencies (note 18)

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
Stockholders’ deficit:
Common stock, $.001 par value. Authorized 250,000,000 shares; 33,616,601 and 33,562,885 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively								34			34
Additional paid-in capital		74,744			71,431			127,916			124,318
Accumulated deficit		(99,426	)		(61,376	)		(149,338	)		(130,474	)
Total shareholders’ (deficit)/equity		(24,657	)		10,080
Total liabilities and shareholders’ (deficit)/equity	$	50,408		$	86,851
Total stockholders’ deficit								(21,388	)		(6,122	)
Total liabilities and stockholders’ deficit							$	63,546		$	78,479

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

AQUESTIVE THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data amounts)

(Unaudited)

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

~~See accompanying notes to the condensed consolidated financial statements.~~

~~Table of Contents~~

~~AQUESTIVE THERAPEUTICS, INC.~~

~~Condensed Consolidated Statements of Changes in Shareholders’ Deficit~~

~~(In thousands, except share amounts)~~

~~(Unaudited)~~

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
)

* Represents balances as of December 31, 2017 as adjusted for the reorganization from LLC to C corporation business structure effective at the close of business on that date.

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
)

	Three Months Ended June 30,						Six Months Ended June 30,
	2020			2019			2020			2019
Revenues	$	21,675		$	11,129		$	30,440		$	23,772
Costs and expenses:
Manufacture and supply		3,539			5,420			7,198			8,926
Research and development		3,847			8,151			8,201			12,454
Selling, general and administrative		13,894			16,246			28,507			34,154
Total costs and expenses		21,280			29,817			43,906			55,534
Income/(loss) from operations		395			(18,688	)		(13,466	)		(31,762	)
Other income/(expenses):
Interest expense		(2,747	)		(1,937	)		(5,518	)		(3,863	)
Interest income		18			153			120			427
Net loss before income taxes		(2,334	)		(20,472	)		(18,864	)		(35,198	)
Income taxes		-			-			-			-
Net loss	$	(2,334	)	$	(20,472	)	$	(18,864	)	$	(35,198	)
Comprehensive loss	$	(2,334	)	$	(20,472	)	$	(18,864	)	$	(35,198	)

Net loss per share - basic and diluted	$	(0.07	)	$	(0.82	)	$	(0.56	)	$	(1.41	)
Weighted-average number of common shares outstanding - basic and diluted		33,589,174			24,980,861			33,579,434			24,972,280

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

AQUESTIVE THERAPEUTICS, INC.

Condensed Consolidated Statements of ~~Cash Flows~~Changes in Stockholders’ Deficit

(In ~~thousands)~~thousands, except share amounts)

(Unaudited)

					Additional					Total
	Common Stock				Paid-in		Accumulated			Stockholders’
	Shares		Amount		Capital		Deficit			Equity/Deficit

For the periods ended June 30, 2020:
Balance at January 1, 2020		33,562,885	$	34	$	124,318	$	(130,474	)	$	(6,122	)
Share-based compensation		19,811		-		1,823		-			1,823
Net loss		-		-		-		(16,530	)		(16,530	)
Balance at March 31, 2020		33,582,696		34		126,141		(147,004	)		(20,829	)
Shares issued under employee stock purchase plan		14,961		-		73		-			73
Share-based compensation		18,944		-		1,702		-			1,702
Net loss		-		-		-		(2,334	)		(2,334	)
Balance at, June 30, 2020		33,616,601	$	34	$	127,916	$	(149,338	)	$	(21,388	)

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

For the periods ended June 30, 2019:
Balance at January 1, 2019	24,957,309	$	25	$	71,431	$	(61,376	)	$	10,080
Adoption of ASU 2014-09, ASU 2018-07 (Note 3C)	-		-		20		(2,852	)		(2,832	)
Share-based compensation	17,830		-		1,422		-			1,422
Net loss	-		-		-		(14,726	)		(14,726	)
Balance at March 31, 2019	24,975,139		25		72,873		(78,954	)		(6,056	)
Shares issued under employee stock purchase plan	31,393		-		132		-			132
Share-based compensation	16,128		-		1,739		-			1,739
Net loss	-		-		-		(20,472	)		(20,472	)
Balance at, June 30, 2019	25,022,660	$	25	$	74,744	$	(99,426	)	$	(24,657	)

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

AQUESTIVE THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

	Six Months Ended June 30,
	2020			2019
Cash flows used for operating activities:
Net loss	$	(18,864	)	$	(35,198	)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation and amortization		1,684			1,543
Share-based compensation		3,625			3,330
Amortization of debt issuance costs and discounts		1,167			781
All other non-cash expenses		(139	)		520
Changes in operating assets and liabilities:
Trade and other receivables		354			(3,684	)
Inventories, net		(314	)		794
Prepaid expenses and other assets		(6,426	)		(416	)
Accounts payable and accrued expenses		(4,237	)		(1,829	)
Deferred revenue		(484	)		(687	)
Net cash used for operating activities		(23,634	)		(34,846	)
Cash flows used for investing activities:
Capital expenditures		(243	)		(486	)
Net cash used for investing activities		(243	)		(486	)
Cash flows used for financing activities:
Proceeds from shares issued under employee stock purchase plan		62			112
Debt repayment		-			(550	)
Payments for taxes on share-based compensation		(89	)		(2.664	)
Net cash used for financing activities		(27	)		(3,102	)
Net decrease in cash and cash equivalents		(23,904	)		(38,434	)
Cash and cash equivalents:
Beginning of period		49,326			60,599
End of period	$	25,422		$	22,165

Supplemental disclosures of cash flow information:
Cash payments for interest	$	4,375		$	2,577
Net (decrease) in capital expenditures included in accounts payable and accrued expenses		(99	)		(313	)
Net increase in financing costs included in accounts payable and accrued expenses		-			150

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

AQUESTIVE THERAPEUTICS, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited, in thousands, except share and per share information)

~~Note 1.~~

Note 1. Corporate Organization and Company Overview

(A) Company Overview

Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) is a ~~specialty~~ pharmaceutical company focused on identifying, developing and commercializing differentiated products tothat address patients’ unmet medical needs and solving critical healthcare challenges, having been formed effective on January 1, 2018 via the conversion of MonoSol Rx, LLC, a Delaware limited liability company, to a Delaware corporation and a simultaneous name change.solve therapeutic problems. The Company has a ~~late-stage~~commercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and other unmet needs, and is developing orally administered complex molecules as alternatives to more invasive therapies. Aquestive is pursuing its business objectives through ~~commercialization of self-developed proprietary products and through~~both in-licensing and out-licensing ~~arrangements.~~arrangements, as well as the commercialization of its own products. Production facilities are located in Portage, Indiana, and corporate headquarters, sales and commercialization operations and primary research laboratory facilities are based in Warren, New Jersey. The Company’s major customer and primary commercialization licensee has global operations headquartered in the United Kingdom with principal operations in the United States; other customers are principally located in the United States.

~~(B) Corporate Conversion~~Aquestive is subject to risks common to companies in similar industries and ~~Reorganization, Stock Splits~~stages of development, including, but not limited to, competition from larger companies, reliance on revenue from a limited number of products and ~~IPO~~customers, adequacy of existing and availability of additional operating and growth capital as and when required, uncertainty of regulatory approval for marketing its product candidates, reliance on a single manufacturing site, new technological innovations, dependence on key personnel, reliance on third-party service providers and sole source suppliers, dependence on patent-protected proprietary technology, ongoing government regulatory compliance requirements, dependence on the clinical and commercial success of its drug candidates, and uncertainty of broad adoption of its approved products, if any, by physicians and consumers. Aquestive is also subject to risks and uncertainties associated with the COVID-19 pandemic. See Note 4. Risks and Uncertainties for further discussion related to COVID-19.

~~Corporate Conversion and Reorganization~~(B) Equity Transaction

Effective on January 1, 2018, the Company converted from a Delaware limited liability company (LLC) into a Delaware corporation pursuant to a statutory conversion and changed its name from MonoSol Rx, LLC (“MonoSol”) to Aquestive Therapeutics, Inc., having previously operated as an LLC since January 2004. At the time of the statutory conversion, the holders of membership units of MonoSol contributed all of their LLC interests to Aquestive Partners, LLC, or APL, in exchange for identical interests in APL. As a result of the exchange, APL was issued 5,000 shares of voting common stock in Aquestive Therapeutics, Inc. and became the parent and sole stockholder of the Company.

~~Stock Splits~~

~~During 2018, the Board of Directors approved the Amended and Restated Certificate of Incorporation of the Company to:~~

~~(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.

~~The net effect of these stock splits is reflected in these financial statements as if they had occurred on January 1, 2018.~~

~~Initial Public~~Equity Offering of Common Stock ~~and Authorized Number of Capital Stock~~

On ~~July 27, 2018,~~December 17, 2019, Aquestive received net proceeds of $37,835 after deducting underwriting discounts of $2,415 for the ~~Company closed the IPO~~sale of ~~4,500,000~~8,050,000 shares of common stock ~~at an offering price of $15.00 per share. The Company received net proceeds of approximately $57,543 after deducting underwriting discounts, commissions,~~in a public offering. Professional fees and ~~offering-related transaction~~other costs of ~~approximately $9,957. The underwriter’s over-allotment option was exercised~~this offering totaled $540, in August 2018 and the Company issued 425,727 additional shares of common stock at $15.00 per share and the Company received additional net proceeds of approximately $5,939, after deducting underwriter discounts of approximately $447. The IPO and overallotment option resulted in total net proceeds of $63,482. Immediately prioraddition to the ~~consummation of the IPO, all of the Company’s outstanding shares of non-voting common stock were automatically converted to 4,922,353 shares of voting common stock.~~underwriting discounts.

~~Table of Contents~~

~~Note 2.~~

Note 2. Basis of Presentation

The accompanying interim unaudited condensed consolidated financial statements were prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and with Article 10 of Regulation S-X for interim financial reporting. In compliance with those rules, certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes for the fiscal year ended December 31, ~~2018~~2019 included in ~~our~~the Company’s Annual Report on Form 10-K filed with the SEC on March ~~14, 2019~~11, 2020 (the ~~“2018~~“2019 Annual Report on Form 10-K”). As included herein, the condensed consolidated balance sheet at December 31, ~~2018~~2019 is derived from the audited consolidated financial statements as of that date. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the results of interim periods have been included. The accompanying financial statements reflect certain reclassifications from previously issued financial statements to conform to the current presentation. The Company has evaluated subsequent events for disclosure through the date of issuance of the accompanying unaudited condensed financial statements.

Any reference in these notes to applicable guidance refers to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

~~Note 3.~~

Note 3. Summary of Significant Accounting Policies

(A) Principles of Consolidation

The interim condensed consolidated financial statements presented herein include the accounts of Aquestive Therapeutics, Inc. and its wholly owned subsidiary, MonoSol Rx, Inc. Other than corporate formation activities, MonoSol Rx, Inc. has conducted no commercial, developmental or operational activities and has no customers or vendors. The results of operations and cash flows reported in these condensed consolidated financial statements should not be regarded as necessarily indicative of results that may be expected in any other interim period or for the entire fiscal year.

Table of Contents

(B) Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and contingent liabilities, at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to estimates and assumptions include allowances for rebates from proprietary product sales, the allowance for sales returns, the useful lives of fixed assets, valuation of share-based compensation and contingencies.

As an emerging growth company, the Company has elected to take advantage of the extended transition period afforded by the Jumpstart Our Business Startups Act for the implementation of new or revised accounting standards and, as a result, the Company will comply with new or revised accounting standards no later than the relevant dates on which adoption of such standards is required for emerging growth companies.

The Company believes that the impact of recently issued accounting standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

Recently Adopted Accounting Pronouncements:

In February 2016, the Financial Accounting Standards Board issued ASU, 2016-02, Leases (Topic 842), and issued amendments in July 2018 provided by ASU 2018-10. This ASU, as amended, requires lessees to recognize lease assets, termed “right-of-use assets” and related lease liabilities on the balance sheet that had previously been classified as operating leases under prior authoritative guidance. For income statement purposes, leases are now required to be classified as either operating or financing leases under a dual model similar to that specified by ASC 840. Operating leases continue to result in straight-line expense while financing leases result in a front-loaded expense pattern in a manner similar to recognition of capital lease expenses under ASC 840.

The Company adopted and applied ASU 2016-02 on January 1, 2020 using the modified retrospective transition provisions of ASC 842 to leases in effect as of that date of adoption, and recorded right-of-use assets totaling $4,048 and lease liabilities as adjusted for accrued lease payments, in the amount of $4,224 based on an estimated incremental borrowing rate of 16.9%, representing the present value of remaining minimum lease payments. The assets and liabilities thus recorded were primarily those related to the Company’s leased plant, laboratory and corporate administrative facilities. The Company elected to apply the ASU-specified practical expedients and accordingly did not re-assess (i) whether its contracts contained a lease under the new definition of a lease, (ii) the classification of those leases, and (iii) initial direct costs of existing leases. In addition, the Company elected not to apply the hindsight expedient in the assessment of lease renewals and resultant term of leases. The Company also elected not to recognize a right-of-use asset and lease liability for those leases with a remaining lease term of 12 months or less. The adoption of ASU 2016-02 did not require a cumulative-effect adjustment to the opening balance of the accumulated deficit at the time of adoption.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, and subsequently issued a number of amendments to this update. The new standard, as amended in Accounting Standards Codification, or ASC 606, provides a single comprehensive model to be used in accounting for revenue arising from contracts with customers and supersedes previous revenue recognition guidance. The standard’s core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers.

The Company adopted this standard on January 1, 2019, using the modified retrospective method and recorded a cumulative effect adjustment of $2,832 to increase the opening balance of accumulated deficit. The impact was primarily related to deferral of a portion of the original upfront and milestone payments of its collaborative licensing arrangements resulting in a deferral of $3,100 of previously recognized revenue as of the adoption date. The cumulative adjustment also reflects $151 net acceleration of revenue related to feasibility and development arrangements with its customers and acceleration of $117 of revenue recognition of the Company’s manufacturing and supply product sales. Under the modified retrospective method of adoption, the comparative information in the consolidated financial statements has not been revised and continues to be reported under the previously applicable revenue accounting guidance, ASC 605.

~~For additional information regarding the Company’s revenue, see Note 5, Revenues and Trade Receivables, Net.~~

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~~In June 2018, the FASB issued ASU 2018-07,~~ ~~Compensation – Stock Compensation (Topic 718): Improvements to Non-Employee Share-Based Payment Accounting,~~ ~~which more closely aligns accounting for share-based payments to nonemployees to that of employees under existing guidance of Topic 718. This guidance supersedes previous guidance provided by~~ ~~Subtopic 505-50, Equity – Equity-Based Payments to Non-Employees. The Company adopted the new standard~~ effective January 1, ~~2019 and recorded a cumulative effect adjustment of $20 to its Accumulated deficit upon adoption.~~

In January 2016, the FASB issued revised guidance governing accounting and reporting of financial instruments (ASU 2016-01) and in 2018 issued technical corrections (ASU 2018-03). This guidance requires that equity investments with readily determinable fair values that are classified as available-for-sale be measured at fair value with changes in value reflected in current earnings. This guidance also simplifies the impairment testing of equity investments without readily determinable fair values and alters certain disclosure requirements. ASU No. 2016-01, ~~Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities~~, also provides guidance as to classification of the change in fair value of financial liabilities. Adoption of this standard was effective on January 1, 2019 and had no material impact on the financial statements given the lack of any such equity investments during the period presented.

~~In March 2016, the FASB issued ASU 2016-09,~~ ~~Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting~~. This guidance simplifies aspects of accounting for employee share-based payments, including income tax consequences, classification of awards as either equity or liabilities, and classifications within the statement of cash flows. This guidance was effective for annual periods beginning after December 15, 2017, with early adoption permitted. Under the Company’s now-terminated Performance Unit Plans (PUPs), vested grants were unable to be exercised prior to either a change in control of the Company or completion of an IPO, and, as a result, expense recognition related to the settlement of these awards was deferred until the PUPs were formally terminated in April 2018. Because the Company has incurred net operating losses since its incorporation, a full valuation allowance has been provided and, accordingly, there was no financial statement impact of adopting the ASU 2016-09 provisions regarding recognition of tax effects associated with share-based compensation.

~~Recent Accounting Pronouncements Not Adopted as of June 30, 2019:~~

~~In February 2016, the FASB issued ASU 2016-02,~~ ~~Leases (Topic 842),~~ which establishes a comprehensive new lease accounting model. The new standard: (i) clarifies the definition of a lease, (ii) requires a dual approach to lease classification similar to current lease classifications, and (iii) causes lessees to recognize leases on the balance sheet as a lease liability with a corresponding right-of-use asset for leases with a lease-term of more than twelve months. The new standard is effective for the Company for fiscal years and interim periods beginning after December 15, 2019 and requires modified retrospective application. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2016-02 will have on its condensed consolidated financial statements.

~~In June 2016, the FASB issued ASU 2016-13,~~ ~~Financial Instruments – Credit Losses (Topic 326)~~, amending existing guidance on the accounting for credit losses on financial instruments within its scope. The guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for the Company beginning after December 15, 2020. The Company is currently evaluating the impact of the adoption of this guidance on its condensed consolidated financial statements.2019.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, providing guidance on the classification of certain cash receipts and payments in the statement of cash flows intended to reduce diversity in practice, including cash flows related to debt prepayment or extinguishment costs and contingent consideration that may be paid following a business combination. The Company adopted this new guidance ~~is effective for the Company for fiscal years beginning after December 31, 2019. Early adoption is permitted. The Company is currently evaluating the effect of the standard~~on January 1, 2020 without material impact on its ~~Condensed Consolidated Statement~~condensed consolidated financial position or results of ~~Cash Flows.~~operations.

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework. The purpose of the update is to improve the effectiveness of the fair value measurement disclosures that allows for clear communication of information that is most important to the users of financial statements. There were certain required disclosures that have been removed or modified. In addition, the update added the following disclosures: (i) changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and (ii) the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The Company adopted this new guidance on January 1, 2020 without material impact on its condensed consolidated financial position or results of operations.

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In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 when the collaborative arrangement participant is a customer for a promised good or service that is distinct within the collaborative arrangement. The guidance also precludes entities from presenting amounts related to transactions with a collaborative arrangement participant that is not a customer as revenue, unless those transactions are directly related to third-party sales. The Company adopted this new guidance on January 1, 2020 without material impact on its condensed consolidated financial position or results of operations.

Recent Accounting Pronouncements Not Adopted as of June 30, 2020:

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326), amending existing guidance on the accounting for credit losses on financial instruments within its scope. The guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for the Company beginning after December 15, 2022. The Company is currently evaluating the impact of the adoption of this guidance on its condensed consolidated financial statements.

In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other Internal-Use Software (Subtopic 350-40: Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The update provides guidance distinguishing between capitalizable service contract implementation costs and contract costs required to be expensed. In addition, the update requires that the term of the hosting arrangement is to include the non-cancelable period of the arrangement plus periods covered by (i) an option to extend the arrangement if the customer is reasonably certain to exercise that option; (ii) an option to terminate the arrangement if the customer is reasonably certain not to exercise the termination option and (iii) an option to extend (or not to terminate) the arrangement in which exercise of the option is in the control of the vendor. This standard will become effective for the Company ~~for its periods~~ beginning January 1, 2021. The amendments may be applied either retrospectively or prospectively to all implementation costs incurred after ~~December 15, 2019; early adoption is permitted.~~the date of adoption. The Company is currently evaluating the impact of ASU ~~2018-13~~2018-15 on its ~~condensed~~ consolidated financial statements.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, which amends accounting for income taxes during interim periods and makes changes to certain income tax classifications. The new standard allows exceptions to the use of the incremental approach for intra-period tax allocation, when there is a loss from continuing operations and income or a gain from other items, and to the general methodology for calculating income taxes in an interim period, when a year-to-date loss exceeds the anticipated loss for the year. The standard also requires franchise or similar taxes partially based on income to be reported as income tax and the effects of enacted changes in tax laws or rates to be included in the annual effective tax rate computation from the date of enactment. The standard will be effective for the Company beginning January 1, 2022, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2019-12 on its consolidated financial statements

Other pronouncements issued by the FASB or other authoritative accounting standards groups with future effective dates are either not applicable or not significant to the condensed consolidated financial statements of the Company.

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~~Note 4.~~

Note 4. Risks and Uncertainties

The Company’s unaudited interim condensed financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Company’s cash requirements for ~~2019~~2020 and beyond include expenses related to continuing development and clinical evaluation of its products, manufacture and supply costs, costs of regulatory filings, patent prosecution expenses and litigation expenses, expenses related to commercialization of its products, ~~debt service requirements, and~~as well as costs to comply with the requirements of being a public ~~company.~~company operating in a highly regulated industry. As of June 30, ~~2019,~~2020, working capital ~~including~~(current assets minus current liabilities) totaled $29,027, which included $25,422 of cash and cash ~~equivalents, totaled $14,435.~~equivalents.

As of June 30, 2020, Aquestive has experienced a history of net losses and the ~~date~~Company’s accumulated deficits totaled $149,338, which have been partially funded by profits from manufacture and supply operations, licensing revenues and certain other services, with the balance of ~~issuance~~the related funding requirements met by the Company’s equity and debt offerings including its 12.5% Senior Secured Notes due 2025. In 2019, the Company raised funding totaling $52,226, consisting of net proceeds of $13,110 from the refinancing of its debt in July 2019, $37,295 from the public offering of 8,050,000 common shares in December 2019, and $1,821 from the exercise of warrants issued in connection with the aforementioned debt refinancing.

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The characteristics described above provide indications that the Company’s ability to execute its near-term business objectives and achieve profitability over the longer term cannot be assured. Further, management views the impact of COVID-19 on the economy, its industry, its customers and suppliers and its own operations as continuing to rapidly evolve, the future effects of which continue to be highly uncertain and unpredictable. Due to current or future interruptions and possible disruptions in health services, operations of the United States Food and Drug Administration (“FDA”), freight and other transportation services, supply, manufacturing, workforce health, availability of acceptable capital, financial and asset monetization markets, and availability of essential human and business requirements, and unforeseeable financial difficulties of the Company’s customers or vendors, the severity, rapidity of the spread, and the duration of the COVID-19 pandemic may be expected to negatively affect a great number of businesses across various industries, including Aquestive. The Company may experience financial and operational adversity in such areas as pre-clinical, clinical trials, regulatory review and approval of various product candidates, customer demand for products and services, customers’ ability to pay for goods and services, supply of pharmaceutical ingredients and other raw materials from approved vendors, ongoing availability of an appropriate labor force and skilled professionals, and additional capital or other funding from capital, financial or monetization markets.

Subject to and absent any material adverse effect of these ~~unaudited interim condensed financial statements,~~and other possible COVID-19 effects, the Company expects that its anticipated revenues from licensed and proprietary products, ~~including expected milestone payments, other co-development payments and royalties, manufacturing and sale revenues at anticipated levels, anticipated sales of its proprietary products,~~ cash on hand, expense management initiatives, additional debt financing under our existing debt arrangement (subject to satisfaction of all conditions to and ~~the net proceeds from the issuance on July 15, 2019~~requirements for further issuances of ~~its 12.5%~~our Senior Secured ~~Notes due 2025,~~Notes), and access to equity markets, including ~~possible future issuances~~ under ~~the Indenture (see Note 18, Subsequent Event), will~~its shelf registration statement, would be adequate to ~~fund its~~meet expected ~~cash requirements~~operating, investing, and financing needs for ~~at least~~ the next twelve months.

To the extent additional funds are necessary to meet ~~liquidity or other cash~~operating needs as the Company continues to execute its business strategy, ~~the Company will seek to satisfy such~~management believes that additional funding requirements would be obtained through ~~additional~~access to appropriate financial markets for a potential monetization of certain revenue streams for its out-licensed apomorphine product (KYNMOBI™) (subject to all conditions under Senior Secured Notes and acceptable market conditions, timing, structure and terms), and availability of debt or equity financings, ~~monetization of royalty streams, the completion of a licensing transaction for one or more of the Company’s pipeline assets, continuing expense reduction initiatives,~~ or a combination of these potential sources of ~~funds. Although the Company has been successful in raising capital in the past, there is~~funds, although management can provide no assurance that these sources of funding will be ~~sufficient or~~ available or on reasonable terms, if at ~~all, which~~all. In addition, the Company may be required to utilize available financial resources sooner than expected. Management has based its expectation on assumptions that could ~~adversely affect its business prospects.~~change or prove to be inaccurate, either due to the impact of COVID-19 or to unrelated factors including factors arising in the capital markets, asset monetization markets, regulatory approval process, regulatory oversight and other factors.

~~Note 5.~~

Note 5. Revenues and Trade Receivables, Net

~~The Company’s revenues~~Revenue from Contracts with Customers

Revenues to date have been earned from ~~partnered commercialized~~the Company’s manufactured products ~~research~~made to order for licensees, including Suboxone® and Zuplenz®, as well as revenue from its self-developed, self-commercialized proprietary product, Sympazan®. Revenues are also earned from its product development services provided ~~to customers, licensing of patent-protected intellectual property and commercialization of a proprietary product.~~under contracts with customers. These activities generate revenues in four primary categories: manufacturing and supply revenue, co-development and research fees, license and royalty revenue, and proprietary product sales, net.

Revenue Recognition and Performance Obligations

~~A performance obligation is a promise in a contract to transfer a distinct good or service~~Aquestive recognizes revenue pursuant to the ~~customer and is~~five-step model embodied in ASC 606, Revenue from Contracts with Customers, to reflect amounts expected to be collectible in exchange for the ~~unit~~transfer of account in the current revenue standard. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. At contract inception, we assess the goodscontractually promised in our contracts with customers and identify a performance obligation for each promise to transfer to the customer a good that is distinct. When identifying our performance obligations, we consider all goods or services ~~promised~~to its customers, as discussed in additional detail in the Company’s 2019 Annual Report on Form 10-K Accordingly, contractually promised goods or services are assessed at contract ~~regardless~~inception to identify those that constitute distinct performance obligations. Contract revenues are allocated to those distinct performance obligations based on estimated standalone values or expected values, and these allocated revenues are recognized at the point in time, or over the period of ~~whether explicitly stated in the customer contract or implied by customary business practices.~~time, that those distinct obligations are satisfied. The Company’s performance obligations consist ~~mainly~~primarily of transferring control of goods, ~~and~~ services or intellectual property that are identified in the contracts, purchase orders or invoices. Variable, or contingent, revenues which may become due from customers, such as milestone payments due upon acceptance of a regulatory filing, regulatory approval, or sales-based milestone payments, are not recognized until contingencies are met in order to fix the customer’s obligation to meet its contractual payment commitment, thereby reducing any significant probability of a revenue reversal.

Manufacture and supply revenue – includes revenue from products manufactured exclusively for specific customers according to their strictly-defined specifications. These products are not manufactured for inventory, have no alternative use and are required to pass specified quality control inspections. The Company’s single performance obligation pursuant to these arrangements is to provide manufactured product of appropriate quality. Accordingly, revenue, net of available discounts, is recognized and the Company is entitled to receive payments at the point in time when quality control requirements are satisfied.

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Proprietary product sales, net - the Company’s performance obligation with respect to its proprietary product sales is satisfied at a point in time ~~which transfers~~coinciding with delivery and transfer of control ~~upon delivery~~ of the product to its customers. ~~The~~Revenue is recognized at this point in time given that the Company ~~considers control to have transferred upon delivery because~~has no ongoing performance obligations, the customer has legal title ~~to the asset,~~and physical possession of the asset and has ~~been transferred, the customer has~~assumed all significant risks and rewards of ownership, ~~of the asset~~ and the Company has a ~~present~~current right to receive payment. These revenues are subject to payment discounts, wholesaler service fees, volume and prompt payment discounts, rebates and other chargebacks, which are estimated at the time the revenue is recorded and concurrently booked. Once all related variable considerations are resolved and uncertainties as to collectible amounts are eliminated, estimates are adjusted to actual allowance amounts. Provisions for these estimated amounts are reviewed and adjusted on no less than a quarterly basis.

License and royalty revenues – the Company may realize revenue from functional or from symbolic licenses. For functional licenses that time. With respect to manufacturing and supply revenue stream, a quantity is ordered and manufactured according to customer’s specifications and represents a single performance obligation. The products manufactured are exclusively for specific customers and have no alternative use. Underdo not require further development or other ongoing activities by the Company, the customer ~~arrangements,~~is viewed as acquiring the ~~Company is entitled~~right to ~~receive payments for progress made to date once~~use the ~~acceptance requirements surrounding quality control~~license as, and when, transferred and revenues are ~~satisfied. Thus, revenues related to this product stream is recognized~~generally recorded at a point in time, ~~when~~subject to contingencies or constraints, if any. For symbolic licenses providing substantial value only in conjunction with other performance obligations to be provided by the Company, such as manufactured ~~product passes quality control testing.~~

products or development services, revenues are generally recorded over the term of the license agreement. Payments received in excess of amounts earned are deferred and recognized over the term of the license or as contingencies or other performance obligations are met.Royalty revenues are estimated based on the provisions of contracts with customers and recognized in the same period that the royalty-based products are sold to the Company’s strategic partners, as all royalties are directly attributable to the Company’s manufacturing activities, and are therefore recognizable at the same time the manufacturing revenue is recognizable. In addition to usage-based royalties, licensing contracts may contain provisions for one-time payments related to certain license fees and milestone achievements. Revenue recognition of these license fees and milestone payments depend on the nature of the specific contract, typically license and milestone payments are recognized at a point in time in the period they are achieved. However, there are limited instances where upon review of the contract, it is determined that the license is non-distinct and limited in nature and does not provide benefit to the customer without purchasing the product, these upfront licensing fees are recognized over time (typically the length of the contract).

Co-development and research ~~fee~~fees – this revenue is recorded over time based upon the progress of services provided in order to complete the specific performance obligation identified in the related ~~contract.~~development or feasibility services agreement. Invoicing occurs as specified in related agreements and may, or may not, coincide with completion of underlying performance obligations and therefore may give rise to contract assets when the value of services completed exceeds amounts that may be invoiced to the customer. Alternatively, in instances in which the customer has made payments in advance of completion of the underlying performance obligations, deferred revenues result that may only be recognized upon completion of those obligations. The Company does not recognize revenue associated with any milestone or performance obligation until there is not a significant probability of a revenue reversal.

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Revenues from the sale of products and services and the subsequent related payments are evidenced by a contract with the customer, which includes all relevant terms of sale. For manufacturing and supply and proprietary product sales, invoices are generally issued upon the transfer of control and co-development and research revenue is typically invoiced based on the contractual payment schedule, or upon completion of the service. Invoices are typically payable 30 to 60 days after the invoice date, however some payment terms may reach ~~105~~75 days depending on the customer. The Company performs a review of each specific customer’s ~~credit worthiness~~creditworthiness and ability to pay prior to acceptance as a customer. Further, the Company performs periodic reviews of its customers’ creditworthiness prospectively.

Contract Assets

In limited situations, certain customer contractual payment terms ~~require billing to occur~~provide for invoicing in ~~arrears; accordingly,~~arrears. Accordingly, some, ~~portions,~~ or all ~~of the Company’s~~ performance obligations ~~are completed~~may be completely satisfied before ~~we are contractually entitled to bill~~ the ~~customer.~~customer may be invoiced under such agreements. In these situations, billing occurs ~~subsequent to~~after revenue recognition, which results in a contract ~~asset.~~asset supported by the estimated value of the completed portion of the obligation. These contract assets are reflected as a component of other receivables within Trade and other receivables onwithin the Condensed Consolidated Balance Sheet. As of June 30, ~~2019~~2020, and ~~January 1,~~December 31, 2019, such current and non-current contract assets were ~~$295,~~$8,503 and ~~$284, respectively.~~$4,363, respectively, consisting primarily of completed but unshipped products manufactured to specific order by certain licensees.

Contract Liabilities

In other limited situations, certain customer contractual payment terms ~~allow advanced billings; accordingly, customer~~are structured to permit invoicing in advance of delivery of a good or service. In such instances, the customer’s cash ~~payments~~payment may be received before satisfaction of some, or ~~all contractual~~any, performance ~~obligations.~~obligations that are specified. In these situations, billing occurs in advance of revenue recognition, which results in contract liabilities. These contract liabilities are reflected as ~~Deferred~~deferred revenue inwithin the Condensed Consolidated Balance Sheet. As remaining performance obligations are satisfied, aan appropriate portion of the deferred revenue balance is ~~recognized in the Company’s results of operations.~~credited to earnings. As of June 30, ~~2019~~2020, and ~~January 1,~~December 31, 2019, such contract liabilities were ~~$2,866~~$4,670 and ~~$3,762,~~$5,154, respectively. ~~Revenue recognized for the six-month period ended June 30, 2019 that was reflected in the deferred revenue balance as of January 1, 2019 was $940.~~

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The Company’s revenues were comprised of the following:

	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended June 30,				Six Months Ended June 30,
	2019		2018		2019		2018		2020		2019		2020		2019
Manufacture and supply revenue	$	8,915	$	8,684	$	15,584	$	20,244	$	7,259	$	8,915	$	14,175	$	15,584
License and royalty revenue		424		4,532		5,046		14,032		12,928		424		13,354		5,046
Co-development and research fees		1,019		712		1,789		3,063		266		1,019		529		1,789
Proprietary product sales, net		771		-		1,353		-		1,222		771		2,382		1,353
Total revenues	$	11,129	$	13,928	$	23,772	$	37,339	$	21,675	$	11,129	$	30,440	$	23,772

Disaggregation of Revenue

The following table provides disaggregated net revenue by geographic area:

	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended June 30,				Six Months Ended June 30,
	2019			2018			2019			2018			2020		2019		2020		2019
United States		$	10,267		$	13,380		$	22,661		$	36,577	$	21,423	$	10,267	$	28,929	$	22,661
Ex-United States			862			548			1,111			762		252		862		1,511		1,111
Total revenues		$	11,129		$	13,928		$	23,772		$	37,339	$	21,675	$	11,129	$	30,440	$	23,772

Non-United States revenues isare derived primarily from products manufactured for the Australian and Malaysian markets.

Trade and other receivables, net consist of the following:

	June 30, 2019			December 31, 2018			June 30, 2020			December 31, 2019

Trade receivables	$	10,036		$	6,610		$	11,808		$	9,094
Contract and other receivables		290			33			1,452			4,363
Less: allowance for bad debts		(88	)		(58	)		(64	)		(124	)
Less: sales-related allowances		(88	)		(104	)		(305	)		(203	)
Trade and other receivables, net	$	10,150		$	6,481		$	12,891		$	13,130

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~~Contract~~contract and other receivables totaled ~~$290~~$1,452 and $4,363 as of June 30, 2020 and December 31, 2019, ~~consisting~~respectively. The June 30, 2020 balance is comprised primarily of ~~contract assets related to~~$1,000 of minimum royalty revenue due from a licensee and the ~~adoption of ASC 606 and certain reimbursable customer costs. Other receivables totaled $33 as of December 31, 2018, consisting primarily of~~remaining balance represents reimbursable costs incurred on behalf of ~~a customer.~~customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services. The December 31, 2019 balance represents reimbursable costs incurred on behalf of customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services. Sales-related allowances for both periods presented are estimated in relation to revenues recognized for sales of ~~Sympazan® beginning with the launch of this product in December 2018.~~Sympazan.

The following table presents the changes in the allowance for bad debt:

	June 30, 2019		December 31, 2018			June 30, 2020			December 31, 2019

Allowance for doubtful accounts at beginning of year	$	58	$	55		$	124		$	58
Additions charged to bad debt expense		30		53
Reversals/additions charged to bad debt expense							(60	)		66
Write-downs charged against the allowance		-		(50	)		—			—
Allowance for doubtful accounts at end of the period	$	88	$	58		$	64		$	124

Sales Related Allowances and Accruals

Revenues from sales of products are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, rebates and co-pay ~~card redemptions.~~support programs. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. These amounts are treated as variable consideration, estimated and recognized as a reduction of the transaction price at the time of the sale. The Company includes these estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized for such transaction will not occur, or when the uncertainty associated with the variable consideration is resolved. The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts and other related information that may become known in the future. The adequacy of these provisions is reviewed on a quarterly basis.

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The following table provides a summary of activity with respect to ~~our~~ sales related allowances and accruals for the six months ended June 30, ~~2019:~~2020:

	Total Sales Related Allowances and Accruals			Total Sales Related Allowances and Accruals

Balance at December 31, 2018	$	585
Balance at December 31, 2019				$	1,377
Provision		847			2,438
Payments / credits		(535	)		(2,111	)
Balance at June 30, 2019	$	897
Balance at June 30, 2020				$	1,704

Total reductions of gross product sales from sales-related allowances and accruals were ~~$847~~$2,438 for the six months ended June 30, ~~2019.~~2020. Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction to trade receivables and ~~totaled $88 and $104 at June 30, 2019 and December 31, 2018, respectively. Accruals~~accruals for wholesaler fees, co-pay cards and rebates ~~are reflected~~ as current ~~liabilities,~~liabilities. The accrued balances relative to these provisions included in Trade and ~~totaled $809~~other receivables, net and ~~$481~~Accounts payable and accrued expenses were $305 and $1,399, respectively, at June 30, ~~2019~~2020 and $203 and $1,174, respectively, at December 31, ~~2018, respectively. There were no sales related allowances and accruals at June 30, 2018, as Sympazan was launched in December 2018.~~2019.

Concentration of Major Customers

Customers are considered major customers when sales exceed 10% of total net sales for the period or outstanding receivable balances exceed 10% of total receivables. For the year ended at December 31, ~~2018,~~2019, Indivior, Inc. (“Indivior”) provided ~~89%~~86% of the total revenues for the period, and as of that date, the Company’s outstanding receivable balance from Indivior represented approximately ~~78%~~80% of gross receivables. For the six months ended June 30, ~~2019, revenues~~2020, there were two customers exceeding the 10% thresholds. Revenues provided by Indivior and Sunovion Pharmaceuticals, Inc. (“Sunovion”) represented approximately ~~86%~~48% and 39%, respectively of total ~~revenues,~~revenue for the six months ended June 30, 2020, and outstanding accounts receivable due from Indivior and Sunovion represented approximately ~~74%~~40% and 38%, respectively of gross receivables.

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~~Note 6.~~

Note 6. Material Agreements

Commercial Exploitation Agreement with Indivior

In August 2008, the Company entered into a Commercial Exploitation Agreement with Reckitt Benckiser Pharmaceuticals, Inc. (with subsequent amendments collectively, the “Indivior License Agreement”). Reckitt Benckiser Pharmaceuticals, Inc. was later succeeded to in interest by Indivior, Inc. Pursuant to the Indivior License Agreement, the Company agreed to manufacture and supply Indivior’s requirements for Suboxone, a sublingual film formulation, both inside and outside the United States on an exclusive basis.

Under the terms of the Indivior License Agreement, the Company is required to manufacture Suboxone in accordance with current Good Manufacturing Practice standards and according to the specifications and processes set forth in the related quality agreements the Company entered into with Indivior. Additionally, the Company is required to obtain Active Pharmaceutical Ingredients (“API”) for the manufacture of Suboxone directly from Indivior. The Indivior License Agreement specifies a ~~maximum~~minimum annual threshold quantity of Suboxone that the Company is obligated to fill and requires Indivior to provide the Company with a forecast of its requirements at various specified times throughout the year.

The Indivior License Agreement provides for payment by Indivior of a purchase price per unit that is subject to adjustment based on the Company’s ability to satisfy minimum product thresholds. Additionally, in the event Indivior purchases certain large quantities of Suboxone during a specified period, Indivior will be entitled to scaled rebates on ~~rest of the world sales only.~~its purchases.

In addition to the purchase price for the Suboxone supplied, Indivior is required to make certain single digit percentage royalty payments tied to net sales value (as provided for in the Indivior License Agreement) in ~~all countries other than~~each of the United States and in the rest of the world subject to annual maximum amounts and limited to the life of the related United States or international patents. In 2012, Indivior exercised its right to buy out its future royalty obligations in the United States under the Indivior License Agreement. Indivior remains obligated to pay royalties for all sales outside the United States.

The Indivior License Agreement contains customary contractual termination provisions, including ~~those for breach,~~with respect to a filing for bankruptcy or corporate dissolution, an invalidation of the intellectual property surrounding Suboxone, orand commission of a material breach of the Indivior License Agreement by either party. Additionally, Indivior may terminate the Indivior License Agreement if the ~~U.S. Food and Drug Administration (“FDA”)~~FDA or other applicable regulatory authority declares the Company’s manufacturing site to no longer be suitable for the manufacture of Suboxone or Suboxone is no longer suitable to be manufactured due to health or safety reasons. The initial term of the Indivior License Agreement was seven years from the commencement date. Thereafter, the Indivior License Agreement automatically renews for successive one-year periods, unless either party provides the other with written notice of its intent not to renew at least one year prior to the expiration of the initial or renewal term.

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Supplemental Agreement with Indivior

On September 24, 2017, the Company entered into an agreement with Indivior, or the Indivior Supplemental Agreement. Pursuant to the Indivior Supplemental Agreement, wethe Company conveyed to Indivior all ~~of our~~ existing and future rights in the settlement of various ongoing patent enforcement legal actions and disputes related to the Suboxone product. The Company also conveyed to Indivior the right to sublicense manufacturing and marketing capabilities to enable an Indivior licensed generic buprenorphine product to be produced and sold by parties unrelated to Indivior or Aquestive. Under the Indivior Supplemental Agreement, ~~we are~~the Company is entitled to receive certain payments from Indivior commencing on the date of the agreement through January 1, 2023. Once paid, all payments made under the Indivior Supplemental Agreement are ~~non-refundable, and total payments under this agreement are capped at $75,000.~~non-refundable. Through February 20, 2019, the at-risk launch date of the competing generic products of Dr. Reddy’s Labs and Alvogen, wethe Company received an aggregate of $40,750 from Indivior under the Indivior Supplemental Agreement, of which $4,250 was collected during the three months ended March 31, 2019. Further payments under the Indivior Supplemental Agreement ~~are~~were suspended until adjudication of related patent infringement litigation is ~~completed.~~finalized. If such litigation is successful, ~~which cannot be assured,~~ in addition to the amounts already received as described in the foregoing, wethe Company may receive up to an additional $34,250, consisting of (i) up to $33,000 in the aggregate from any combination of (a) performance or event-based milestone payments and (b) single digit percentage royalties on net revenue earned by Indivior on sales of Suboxone and (ii) ~~and~~ an additional $1,250 that was earned through the issuance ~~to the Company~~ of additional process patent ~~rights.~~rights to the Company. The aggregate payments under this Indivior Supplemental Agreement are capped at $75,000.

All payments made by Indivior to the Company pursuant to the Indivior Supplemental Agreement are in addition to, and not in place of, any amounts owed by Indivior to the Company pursuant to the Indivior License Agreement. Indivior’s payment obligations under the Indivior Supplemental Agreement are subject to certain factors affecting the market for Suboxone and may terminate prior to January 1, 2023 in the event certain contingencies relating to such market occur.

License Agreement with Sunovion Pharmaceuticals, Inc.

InOn April 1, 2016, wethe Company entered into a license agreement with Cynapsus Therapeutics Inc. (which was later succeeded to in interest by ~~Sunovion)~~Sunovion Pharmaceuticals, Inc.,), referred to as the Sunovion License Agreement, pursuant to which ~~we granted~~ Sunovion obtained an exclusive, worldwide license (with the right to sub-license) to certain intellectual property, including existing and future patents and patent applications, covering all oral films containing ~~APL-130277 (apomorphine)~~apomorphine for the treatment of off episodes in Parkinson’s disease ~~patients,~~patients. The FDA granted approval of Kynmobi on May 21, 2020, as ~~well as two other fields. Our licensee, Sunovion, as sponsor~~anticipated. This approval has triggered Sunovion’s obligation to remit a payment of ~~APL-130277, submitted an NDA to~~$4,000 (the “FDA Approval Milestone Payment”) due on the earlier of: (a) the first day of product availability at a pharmacy in the United States; or (b) within six months of the FDA ~~on March 29, 2018. According to statements by Sunovion, following~~approval. This amount is included in Trade and other receivables as of June 30, 2020 and in the ~~January 2019 PDUFA date, Sunovion received a Complete Response Letter from~~License and royalty revenues for the ~~FDA which requires additional data, but does not require additional clinical studies.~~three- and six-months ended June 30, 2020.

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In consideration for the rights granted to Sunovion under the Sunovion License Agreement, wethe Company received aggregate payments totaling $18,000 to date. In addition to the upfront payment of $5,000, ~~we have~~the Company also earned an aggregate of ~~$13,000~~$17,000 in connection with specified regulatory and development milestones in the United States and Europe (the “Initial Milestone Payments”), ~~all~~ of which ~~have~~$13,000has been received ~~to date.~~by the Company. No payments were received under the Sunovion License Agreement during the ~~three~~three- and ~~six months~~six-month period ended June 30, ~~2019. We are~~2020. The Company is also entitled to receive certain contingent one-time milestone payments related to product availability and regulatory approval in the United States and Europe, certain one-time milestone payments based on the achievement of specific annual net sales thresholds of ~~APL-130277,~~Kynmobi, and ongoing mid-single digit percentage royalty payments related to the net sales of ~~APL-130277~~Kynmobi (subject to reduction to low-single digit percentage royalty payments in certain circumstances), subject to certain minimum payments. The maximum aggregate milestone payments that may be paid to usthe Company pursuant to the Sunovion License Agreement is equal to $45,000. With the exception of the Initial Milestone Payments and the FDA Approval Milestone Payment, there can be no guarantee that any such milestones will in fact be met or that additional milestone payments will be payable. There is a minimum guaranteed royalty of $1,000 for each of the next eight years. As of June 30, 2020, the Company recorded minimum royalty receivables of $8,000 in aggregate, of which $1,000 is included in Trade and other receivables and $7,000 is included in Intangibles, net and other assets. The Company recognized $8,000 in royalty revenue which is recorded in License and royalty revenues for the three- and six- months ended June 30, 2020.

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Effective March 16, 2020, the Company entered into a first amendment (the “Amendment”) to the Sunovion License Agreement. The Amendment was entered into for the primary purpose of amending the Sunovion License Agreement as follows: (i) including the United Kingdom and any other country currently in the European Union (EU) which later withdraws as a member country in the EU for purpose of determining the satisfaction of the condition triggering the obligation to pay the third milestone due under the Sunovion License Agreement, (ii) extending the date after which Sunovion has the right to terminate the Sunovion License Agreement for convenience from December 31, 2024 to March 31, 2028, (iii) modifying the date the first minimum annual royalty is due to be paid by Sunovion to the Company from January 1, 2020 to April 1, 2020, and (iv) modifying the termination provisions to reflect the Company’s waiver of the right to terminate the Sunovion License Agreement in the event that Kynmobi was not commercialized by January 1, 2020. This Sunovion License Agreement will continue until terminated by ~~us or~~ Sunovion in accordance with the termination provisions of the Amendment to the Sunovion License Agreement. ~~Absent early termination, the~~The Sunovion License Agreement continues (on a country-by-country basis) until the expiration of all applicable licensed patents. Upon termination of the Sunovion License Agreement, all rights to intellectual property granted to Sunovion to develop and commercialize products will revert to the Company and Sunovion must continue to pay royalties to the Company on each sale of ~~Sunovion’s~~Sunovion's remaining inventory of products commercialized by Sunovion which include apomorphine as their API.

Agreement to Terminate CLA with KemPharm

In March 2012, the Company entered into an agreement with KemPharm, Inc. (“KemPharm”) to terminate a Collaboration and License Agreement entered into by the Company and KemPharm in April 2011. Under this termination arrangement, ~~we have~~the Company has the right to participate in any and all value that KemPharm may derive from the commercialization or any other monetization of ~~KP 415~~KemPharm’s KP-415 and ~~KP 484~~KP-484 compounds or their derivatives. Among these monetization transactions are those related to any business combinations involving KemPharm and collaborations, royalty arrangements, or other transactions from which KemPharm may realize value from these compounds. During September 2019, the Company received $1,000 from its 10% share of milestone payments paid to KemPharm under its licensing of KP-415 and KP-484 to a third party. The Company has ~~not~~also received ~~payments~~a payment of $500 under this arrangement during ~~any~~June 2020, which is included in License and royalty revenues for the three- and six-month periods ended June 30, 2020, in connection with the FDA’s acceptance of ~~the periods presented herein,~~an New Drug Application (“NDA”) filing for KP-415. A Prescription Drug User Fee Act (PDUFA) target date for completion of FDA review has been scheduled for early March 2021. The Company’s share of remaining milestone payments associated with KP-415 approval and certain targeted labeling goals within timeframes ending in July 2021 may reach $4,800. However, there can be no guarantee that approvals, goals or any such payments will be ~~made~~achieved or received in the future.

~~Note~~ 7.

Note 7. Financial Instruments – Fair Value Measurements

Certain assets and liabilities are reported on a recurring basis at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ~~To increase consistency and comparability in such measurements, the FASB established a three-level hierarchy which requires maximization of~~Valuation techniques used to measure fair value must maximize the use of observable inputs and ~~minimization of~~minimize the use of unobservable ~~inputs when estimating~~inputs. Financial assets and liabilities carried at fair ~~value. The~~value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, ~~include:~~of which the first two are considered observable and the last is considered unobservable:

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.

The carrying amounts reported in the balance sheets for trade and other receivables, prepaid and other current assets, accounts payable and accrued expenses, and deferred revenue approximate their fair values based on the short-term maturity of these assets and liabilities.

The ~~Company’s Level 1 assets for the periods presented included cash and cash equivalents, including money market funds. The~~ Company ~~held no Level 2 or Level 3 assets or liabilities as~~granted warrants to certain holders of ~~either balance sheet date presented herein. Prior to exercise~~its Notes in connection with ~~the~~its debt refinancing in July ~~2018 IPO, outstanding~~2019. These warrants ~~held by Perceptive Credit Opportunities Fund~~ were ~~categorized as Level 3 liabilities. This warrant liability was estimated at fair value~~valued based primarily on Level 3 inputs and an independent third-party ~~appraisals~~appraisal prepared ~~and reported periodically,~~as of the grant date consistent with generally-accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation. See Note 1314 for further information on ~~the Company’s~~these warrants. In addition, Level 3 inputs provide the basis for estimated fair values of stock options granted during 2018 and 2019, which values were estimated using the Black-Scholes-Merton pricing model based on assumptions disclosed in Note 15.

The carrying amounts reported in the balance sheets for Trade and other receivables, Prepaid and other current assets, Accounts payable and accrued expenses, and deferred revenue approximate fair value based on the short-term maturity of these assets and liabilities.

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~~Note 8.~~

Note 8. Inventories, Net

The components of Inventory, net is as follows:

	June 30, 2019		December 31, 2018		June 30, 2020		December 31, 2019

Raw material	$	1,247	$	1,283	$	1,206	$	1,244
Packaging material		2,366		2,975		1,256		1,096
Finished goods		1,034		1,183		711		519
Total inventory, net	$	4,647	$	5,441	$	3,173	$	2,859

The Company manufactures Suboxone exclusively to order for its major customer subject to strict quality standards and recognizes revenue upon completion of all customary quality control evaluations, which occurs prior to actual shipment.

~~Note 9.~~

~~Property and Equipment, Net~~

Note 9. Property and Equipment, Net

	Useful Lives	June 30, 2019			December 31, 2018			Useful Lives	June 30, 2020			December 31, 2019

Machinery	3-15 yrs	$	20,905		$	20,681		3-15 yrs	$	21,169		$	21,088
Furniture and fixtures	3-15 yrs		1,150			1,150		3-15 yrs		1,209			1,150
Leasehold improvements	(a)		21,333			21,333		(a)		21,333			21,333
Computer, network equipment and software	3-7 yrs		2,657			2,579		3-7 yrs		2,787			2,787
Construction in progress			1,526			1,655				1,417			1,412
			47,571			47,398				47,915			47,770
Less: accumulated depreciation and amortization			(36,638	)		(35,191	)			(39,458	)		(38,044	)
Total property and equipment, net		$	10,933		$	12,207			$	8,457		$	9,726

(a)

Leasehold improvements are amortized over the shorter of the lease term or their estimated useful lives.

Total depreciation and amortization related to property and equipment was ~~$711~~$700 and ~~$765~~$711 for the three-month periods ended June 30, ~~2019~~2020 and ~~2018,~~2019, respectively. For the respective six-month periods, these expenses totaled ~~$1,447~~$1,414 and ~~1,705.~~$1,447.

Note 10. Right-of-Use Assets and Lease Obligations

The Company leases all realty used as its production and warehouse facilities, corporate headquarters, commercialization operations center and research and laboratory facilities. None of these three leases include the characteristics specified in ASC 842, Leases, that require classification as financing leases and, accordingly, these leases are accounted for as operating leases. These leases provide remaining terms between 2.8 years and 6.3 years, including renewal options expected to be exercised to extend the lease periods. Measurement of the operating lease liability reflects an estimated discount rate of 16.9% applied to minimum lease payments, including expected renewals, based on the incremental borrowing rate experienced in the Company’s latest collateralized debt refinancing. Right-of-use assets recorded upon adoption of ASC 842 totaled $4,048. For the three- and six-month periods ended June 30, 2020, total operating lease expenses under these leases totaled $377 and $819, respectively, including variable lease expenses such as common area maintenance and operating costs totaling $60 and $166, respectively. Total payments to these lessors during the six-month period ended June 30, 2020 were $633.

Maturities of the Company’s operating lease liabilities are as follows:

Remainder of 2020	$	641
2021		1,287
2022		1,295
2023		944
2024		565
2025		565
2026		424
Total lease payments		5,721
Less: imputed interest		(1,792	)
Total operating lease liabilities	$	3,929

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~~Note 10.~~

Note 11. Intangible Assets, Net and Other Assets

The following table provides the components of identifiable intangible assets, all of which are finite lived:

	June 30, 2019			December 31, 2018			June 30, 2020			December 31, 2019

Purchased technology-based intangible	$	2,358		$	2,358		$	2,358		$	2,358
Purchased patent		509			509			509			509
		2,867			2,867			2,867			2,867
Less: accumulated amortization		(2,689	)		(2,663	)		(2,740	)		(2,714	)
Total intangible assets, net	$	178		$	204
Intangible assets, net								127			153
Royalty receivable								7,000			-
Other assets, primarily security deposits								289			286
Total intangible assets, net and other assets							$	7,416		$	439

Amortization expense was $12 and $13 ~~and $12~~ for each of the three-month periods ended June 30, ~~2019~~2020 and ~~2018,~~2019, respectively. For the corresponding six-month periods, these expenses totaled ~~$26~~$25 and ~~$25,~~$26, respectively. During the remaining life of the purchased patent, estimated annual amortization expense is $50 for each of the years from ~~2019~~2020 to 2022. Royalty receivable consists of seven annual $1,000 minimum royalty payments due from Sunovion, the last of which is due in March 2028. See Note 6 above.

~~Note 11.~~

Note 12. Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following:

	June 30, 2019		December 31, 2018		June 30, 2020		December 31, 2019

Accounts payable	$	20,034	$	20,436	$	8,787	$	12,274
Accrued compensation		2,282		3,604		2,981		3,758
Accrued withholding tax for share-based compensation		-		2,515
Real estate and personal property taxes		176		388
Accrued distribution expenses		809		481		1,399		1,174
Other		178		207		223		543
Total accounts payable and accrued expenses	$	23,479	$	27,631	$	13,390	$	17,749

Note 13. 12.5 % Senior Secured Notes and Loans Payable

12.5% Senior Secured Notes

On July 15, 2019, the Company completed a private placement of up to $100 million aggregate principal of its 12.5% Senior Secured Notes due 2025 (the “Notes”) and issued warrants for two million shares of common stock (the “Warrants”), $.001 par value per share, through the structuring agent, Morgan Stanley & Co., LLC, and entered into a purchase agreement and related agreements including a Collateral Agreement with U.S. Bank National Association, as trustee and collateral agent, and a Lien Subordination and Intercreditor Agreement for the benefit of Madryn Health Partners, other institutional noteholders and U.S. Bank National Association in dual roles providing terms and governing an asset-based loan facility.

Upon closing of the Indenture for such Notes (“Indenture”), the Company issued $70,000 of the principal of the Notes (the “Initial Notes”) along with the Warrants and rights of first offer (the “First Offer Rights”) to the lenders participating in this transaction for Notes and Warrants (the “Lenders”). Issuance of the Initial Notes and Warrants provided net proceeds of $66,082. In addition to the Initial Notes, the Indenture may provide access to further loans of up to $30,000 that may become available in two tranches of Additional Notes tied to the NDA filing for and FDA U.S. marketing approval of Libervant™, an important part of the Company’s drug candidate pipeline. Subject to approval of the holder of a majority of the outstanding principal amount of the Notes in its discretion, and provided that no events of default exist, the Company may offer to the Lenders participation in a $10,000 additional offering of 12.5% senior secured notes (the “First Additional Offering”) under terms similar to the Initial Notes, on or before March 31, 2021, upon the filing of the Libervant NDA with the FDA. A second identical funding opportunity would allow the Company to obtain, on or before March 31, 2021, an additional $20,000 if the first option has been elected and funded, or, if not elected or funded, an additional $30,000 may be offered for issuance following FDA approval of Libervant for marketing in the U.S. There can be no assurance that any additional financing will be consummated.

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~~Note 12.~~

~~Loans Payable~~

~~On August 16, 2016,~~Proceeds from issuance of the ~~Company entered into a Loan Agreement~~Initial Notes and ~~Guaranty (the “Loan Agreement”) with~~Warrants were used to fully repay the Company’s $56,340 outstanding indebtedness to Perceptive Credit Opportunities Fund, LP ~~(“Perceptive”~~(the “Perceptive Loan”)~~. Upon closing,~~, related early repayment fees and legal and other fees incurred to obtain the ~~Company borrowed $45,000 from Perceptive and was permitted to borrow up to an additional $5,000 within one year~~loan.

The Notes provide a stated fixed rate of 12.5%, payable quarterly in arrears, with the initial quarterly principal repayment of the ~~closing date based upon achievement of a defined milestone which was met in March 2017~~Initial Notes due on September 30, 2021, and the ~~balance~~final quarterly payment due at maturity on June 30, 2025. Principal payments are scheduled to increase annually from 10% of the ~~facility was borrowed at that time. The~~face amount of debt then outstanding during the first four quarters to 40% of the initial loan ~~proceeds were used to pay~~principal during the existing debt obligation of $37,500 due to White Oak Global Advisors, LLC, with the balance available for general business purposes. On July 15, 2019, this loan from Perceptive was repaid in full as part of a refinancing transaction. See Note 18, Subsequent Events.final four quarters.

~~On May 21, 2018,~~A debt maturity table is presented below:

Remainder of 2020	$	-
2021		3,500
2022		10,500
2023		17,500
2024		24,500
2025		14,000
Total	$	70,000

The Company may elect, at its option, to prepay the ~~Company and Perceptive agreed~~Notes at any time at premiums that range from 101.56% of outstanding principal if prepayment occurs on or after the 5^th anniversary of the issue date of the Notes to ~~make certain amendments to~~112.5% if payment occurs during the ~~loan agreement then in effect.~~third year after the issuance of the Notes. In the event that redemption occurs within the two years after the issuance of the Notes, a ~~qualified IPO could~~make-whole fee is required, based on the present value of remaining interest payments using an agreed-upon discount rate linked to the then-current U.S. Treasury rate. The Indenture also includes a change of control provision under which the Company may be ~~consummated~~required to repurchase the Notes at 101% of the remaining principal plus accrued interest at the election of the Lenders.

Collateral for the loan under the Notes consists of a priority lien on ~~or before December 31, 2018,~~substantially all property and assets, including intellectual property, of the Company. This secured obligation provides payment rights that are senior to all existing and future subordinated indebtedness of the Company and ~~Perceptive agreed~~provides Lenders with perfected security interests in substantially all of the Company’s assets. In the event that asset-based loans of up to ~~postpone the initial loan principal payments, delay the loan maturity date~~$10,000 (“ABL Facility”) may be obtained, subject receivables and inventory assets will provide a second priority lien to ~~December 16, 2020 and retain interest rate terms, payable monthly, at one-month LIBOR or approximately 2% plus 9.75%, subject~~senior secured Noteholders. The Company’s license of its IP to a ~~minimum rate~~third-party drug development enterprise (specifically, Sunovion’s Kynmobi product) is one of ~~11.75%. Accordingly, commencing on May 31, 2019, seven monthly loan~~the various assets serving as collateral for the loan. The Indenture permits the Company to monetize this asset while specifying that a portion of the proceeds, up to $40,000 if the First Additional Offering has not been elected or funded, or, $50,000 if it has been elected and funded, must be applied to prepay the Initial Notes, at 112.5% of the principal ~~payments were due in~~amount of the Notes being repurchased, plus accrued and unpaid interest, if any, thereon, to the date of the repurchase, to the extent elected by the Note holders, assuming that such monetization, up to such $40,000 or $50,000 level, as applicable, equals or exceeds those levels and if such monetization does not equal or exceed such level, such prepayment would be pro-rated among the Note holders. To the extent that Lenders do not elect repayment of the debt at the date of the monetization, the amount not elected up to $40,000 (or $50,000 if an additional tranche is issued) will be held in a collateral account until approval of ~~$550. Thereafter, monthly principal payments in~~Libervant by the ~~amount of $750 were due through the maturity date, December 16, 2020,~~FDA for U.S. marketing, at which time the full amount of the remaining outstanding loan balance was due. At June 30, 2019 and December 31, 2018, respectively, $550 and $4,600 was classified as current debt. The Company’s tangible and intangible assets are subjectthis cash collateral is to ~~first priority liens~~be released to the extent of the outstanding debt. Further, under the Loan Agreement, as amended, the Company was permitted, subject to Perceptive’s consent, to monetize the royalty and fees derived from sales of certain apomorphine products and, in connection with such monetization, Perceptive had agreed to release liens related to these royalties and fees. Other significant terms of the Loan Agreement, as amended, included financial covenants, change of control triggers and limitations onCompany. Proceeds more than $40,000 (or $50,000 if an additional ~~indebtedness, asset sales, acquisitions and dividend payments. Financial covenant requirements included (1) minimum liquidity under which a $4,000 minimum cash balance must~~tranche is issued) can be ~~maintained at all times and (2) a minimum revenue requirement under which minimum revenues~~used immediately for ~~the trailing twelve consecutive months, measured at the end of each calendar quarter.~~general corporate purposes. As of June 30, ~~2019,~~2020, the Company ~~was in compliance~~complied with all ~~financial~~of its covenants under the Loan Agreement, as amended. Also, as of that date, the carrying value of the Company’s loan payable approximated its market value. At closing of the Loan Agreement, as amended, Perceptive received a warrant to purchase senior common equity interests representing 4.5% of the fully diluted common units of the Company on an as converted basis, which was automatically exercised in full at the time of the IPO (see Note 13).Indenture.

The Company capitalizes legal and other third-party costs incurred in connection with obtaining debt as deferred debt issuance costs and applies the unamortized portion as a reduction of the outstanding face amount of the related loan in accordance with ASU 2015-03, Interest – Imputation of Interest: Simplifying the Presentation of Debt Issuance Costs. Similarly, the Company amortizes debt discounts, such as those represented by warrants issued to its ~~lenders,~~holders, and offsets those as a direct reduction of its outstanding debt. Amortization ~~expense~~expenses arising from deferred debt issuance costs and debt discounts related to the Notes were $583 and $1,167 for the three- and six-month periods ended June 30, 2020, respectively, while comparative amortization expenses derived from deferred debt issuance costs and debt discounts related to the Perceptive Loan for the three- and six-month periods ended June 30, 2019 were $393 and ~~2018 were $781 and $923, respectively; for the corresponding three-month periods these expenses totaled $392 and $465.~~

$782, respectively. Unamortized deferred debt issuance costs and deferred debt discounts totaled ~~$2,016~~$8,495 and $9,662 as of June 30, ~~2019~~2020 and ~~$2,797 as of~~ December 31, ~~2018.~~2019, respectively.

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~~Note 13.~~

~~Warrants~~

Loans Payable - Perceptive

~~The~~In August 2016, the Company entered into a Loan Agreement and Guaranty with Perceptive Credit Opportunities Fund, LP (“Perceptive”) under which the total available facility of $50,000 had been borrowed as of March 2017. At closing, Perceptive received a warrant ~~issued~~ to Perceptive in connection with the Agreement was, by its terms, set to expire on August 16, 2023 and provided certain rights and preferences including anti-dilution adjustments so that, upon exercise, they would representpurchase senior common equity interests representing 4.5% of the ~~Company’s~~ fully diluted common ~~stock~~units of the Company on an as converted basis, ~~subject to dilution for certain financing including the issuance of shares upon termination of our PUPs. The warrant also provided Perceptive with a put right~~ which ifwas automatically exercised under certain circumstances, would require the Company to purchase the warrant for $3,000 within the first year of the loan or $5,000 thereafter. Because these re-purchase terms could have required net-cash settlement, the appraised value of this warrantin full at the time of ~~issuance~~Aquestive’s IPO. In July 2019, the Perceptive Loan was paid in full in connection with the completion of ~~$5,800 was classified as~~the sale of the Notes and Warrants described above. The early extinguishment of this debt resulted in a ~~liability, rather than as a component~~charge to third quarter 2019 earnings of ~~equity,~~an amount of $4,896, including an early retirement premium of $2,944 and ~~was~~the remaining balances of the unamortized loan discount and loan acquisition costs.

Note 14. Warrants Issued to 12.5% Senior Secured Noteholders

The Warrants that were issued in conjunction with the Notes described above expire on June 30, 2025 and entitle the holders of the Notes to purchase two million shares of the Company’s common stock at $4.25 per share and include specified registration rights. Management estimated the fair value of the Warrants to be $6,800, assisted by an independent third-party appraiser. The fair value of these Warrants is treated as a debt discount, amortizable over the term of the Warrants, with the unamortized loan portion applied to reduce the face amount of the ~~loan~~Notes in the Company’s balance sheet. Additionally, since the Warrants issued do not provide warrant redemption or put rights within the control of the holders that could require the Company to make a payment of cash or other assets to satisfy the obligations under the Warrants, except in the case of a “cash change in control”, the fair value attributed to the Warrants is presented in Additional-paid in capital in the accompanying Condensed Consolidated Balance ~~Sheet.~~Sheets.

~~Immediately prior to pricing~~Certain holders of the ~~Company’s IPO, Perceptive received 863,400~~Notes exercised Warrants for the purchase of 428,571 shares of common stock, ~~issuable pursuant to~~and proceeds therefor totaling $1,821 were received on December 16, 2019. There were no Warrants exercised by the ~~automatic exercise~~holders of ~~warrants at a total price of $116. As a result,~~ the ~~warrant liability of $12,951 was reclassified to Additional paid-in capital~~Notes during the third quarter of 2018. A Level 1 market price of $15.00, the initial price at which the Company’s common stock was publicly offered, was used in determining fair value as of the warrants’ conversion date.six-month period ended June 30, 2020.

During interim periods, the Company used an independent third-party valuation to assist in determining the fair value of these warrants due to the absence of available Level 1 and Level 2 inputs. During the three-months and six months period June 30, 2018, as a result of an increase in the estimated fair value of this warrant liability, net losses included a non-cash loss of $1,859 and $1,162, respectively. No gain or loss was recognizable for any periods subsequent to the date of exercise of the warrants in July 2018. The fair values at both the date of the issuance and the dates of all interim balance sheets prior to exercise were based on unobservable Level 3 inputs. Fair value was based on the aggregate equity of the Company, which was estimated utilizing the income and market valuation approaches. A probability weighted return model was then utilized to allocate the resulting aggregate equity value of the Company to the underlying securities. Estimates and assumptions impacting the fair value measurement included the following factors: the then-current state of development of the Company’s pipeline product candidates, including status of clinical trials; the Company’s progress towards an IPO, including selection of investment bankers, assessment of the IPO marketplace and other funding alternatives and a discount rate of 26.5% and a volatility rate of 90%.

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~~Note 14.~~

Note 15. Net Loss Per Share

Basic net income or loss per share is calculated by dividing net income or loss by the weighted-average number of common ~~shares.~~

Asshares outstanding during the periods. Diluted net income or loss per common share is similarly computed and includes the effect of any additional dilutive potential common shares outstanding during the periods. These potential common shares are excluded from the computation of net loss per share to the extent that their effects are antidilutive, and as a result of the Company’s net losses incurred for the ~~three~~three- and six-month periods ended June 30, 2020 and 2019, ~~and June 30, 2018,~~ respectively, ~~all~~no potentially dilutive ~~instruments outstanding would~~securities have ~~anti-dilutive effects on per-share calculations for these periods. Therefore, basic and~~been included in the computation of diluted net loss per share ~~were~~for the ~~same, as reflected~~periods presented below.

	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended June 30,						Six Months Ended June 30,
	2019			2018			2019			2018			2020			2019			2020			2019
Numerator:
Net loss	$	(20,472	)	$	(36,493	)	$	(35,198	)	$	(32,394	)	$	(2,334	)	$	(20,472	)	$	(18,864	)	$	(35,198	)
Denominator:
Weighted-average number of common shares – basic		24,980,861			19,188,624			24,972,280			17,144,492			33,589,174			24,980,861			33,579,434			24,972,280
Loss per common share - basic	$	(0.82	)	$	(1.90	)	$	(1.41	)	$	(1.89	)
Loss per common share – basic and diluted													$	(0.07	)	$	(0.82	)	$	(0.56	)	$	(1.41	)

~~As of June 30, 2019, the Company’s potentially dilutive instruments included 1,983,142~~The following outstanding stock options, ~~to purchase common shares and 142,852 unvested~~ restricted stock units ~~(“RSUs”) that were~~and warrants are antidilutive and have been excluded from the computation of ~~diluted weighted average shares outstanding because these securities had an anti-dilutive impact due to~~ the loss ~~reported. No such equity securities were issued as of~~per common share for the periods ended June ~~30, 2018.~~30:

	June 30, 2020		June 30, 2019
Options on common shares outstanding		3,167,192		1,983,142
Restricted stock units unvested		14,233		142,852
Warrants on common shares outstanding		1,571,429		—
Total potentially antidilutive derivatives excluded from losses per share		4,752,854		2,125,994

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~~Note 15.~~

Note 16. Share-Based Compensation

The Company recognized share-based compensation in its Condensed Consolidated Statements of Operations and Comprehensive Loss during ~~2019~~2020 and ~~2018~~2019 as follows:

	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended June 30,				Six Months Ended June 30,
Expense classification:	2019		2018		2019		2018
									2020		2019		2020		2019
Manufacture and supply	$	72	$	345	$	116	$	345	$	72	$	72	$	135	$	116
Research and development		140		2,186		348		2,186		183		140		365		348
Selling, general and administrative		1,598		24,774		2,866		24,774		1,510		1,598		3,125		2,866
Total share-based compensation expenses	$	1,810	$	27,305	$	3,330	$	27,305	$	1,765	$	1,810	$	3,625	$	3,330

Share-based compensation from:
Restricted stock units	$	467	$	—	$	930	$	—	$	309	$	467	$	773	$	930
Stock options		1,323		7		2,380		7		1,445		1,323		2,841		2,380
Non-voting common shares		—		27,298		—		27,298
Employee stock purchase plan		20		—		20		—		11		20		11		20
Total share-based compensation expenses	$	1,810	$	27,305	$	3,330	$	27,305	$	1,765	$	1,810	$	3,625	$	3,330

The 2018 expense presented above also include those arising from the Company’s prior incentive plan that was terminated and settled in April 2018 through the issuance of non-voting common shares. Under that Performance Unit Plan, vest grants were not exercisable prior to a change in control or completion of an IPO and accordingly, compensation expenses for these awards were initially recognized in April 2018 upon plan participant and Board approval.

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Share-Based Compensation Equity Awards

The following tables ~~provides~~provide information about the Company’s restricted stock unit and stock option ~~unit~~ activity during the ~~six months~~six-month period ended June 30, ~~2019:~~2020:

Restricted stock units:	Number of Units			Weighted Average Grant Date Fair Value
Restricted Stock Unit Awards (RSUs):						Number of Units			Weighted Average Grant Date Fair Value
	(in thousands)					(in thousands)
Unvested at December 31, 2018		205		$	14.77
Unvested at December 31, 2019							74		$	14.64
Granted		—			—		—			—
Vested		(59	)		15.03		(60	)		15.03
Forfeited		(3	)		13.00		—			—
Unvested at June 30, 2019		143		$	14.70
Unvested at June 30, 2020							14		$	13.00
Grant date fair value of shares vested during the period	$	896				$	896
Unrecognized compensation costs of RSU awards at June 30, 2019	$	1,881
Unrecognized compensation costs at June 30, 2020						$	125

Unrecognized compensation costs related to awards of RSUs are expected to be recognized over a weighted-average period of less than ~~three~~two years.

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

Stock Option Awards:	Number of Options			Weighted Average Exercise Price
	(in thousands)
Outstanding at December 31, 2019		2,231		$	10.42
Granted		966			2.60
Exercised, Forfeited, Expired		(30	)		(3.89	)
		—			—
Outstanding at June 30, 2020		3,167		$	8.10
Vested or expected to vest at June 30, 2020		2,949		$	8.10
Exercisable at June 30, 2020		836		$	11.85

The fair values of stock options granted during ~~2019~~2020 were estimated using the Black-Scholes-Merton pricing model based on the following assumptions:

Expected dividend yield	None		0	%
Expected volatility		~~85 - 95~~ 100	%
Expected term (years)		5.5 - 6.1
Risk-free interest rate		~~1.9 - 2.6~~ 0.4 – 1.7	%

The weighted average grant date fair value of stock options granted during ~~2019~~2020 was ~~$7.51.~~$2.04. During the ~~six months~~six-month period ended June 30, ~~2019,~~2020, stock options were granted with exercise prices ranging from ~~$4.38~~$1.54 to ~~$8.05,~~$5.69, and accordingly, given ~~Aquestive’s~~the Company’s share price of ~~$4.20~~$4.86 at ~~the close of the Company’s second quarter of 2019, these options~~June 30, 2020, certain shares granted during this period provided no intrinsic value at that ~~date. Similarly,~~date totaling $2,646. No intrinsic value was provided by stock options granted ~~in 2018 provided no intrinsic value at~~during the six-month period ended June 30, 2019.

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As of June 30, ~~2019, $11,352~~2020, $8,174 of ~~total~~ unrecognized compensation ~~expenses~~expense related to non-vested stock options is expected to be recognized over a weighted average period of ~~2.3~~1.9 years from the date of grant.

Employee ~~stock purchase plan~~Stock Purchase Plan

The ~~Company’s Board of Directors adopted the~~ Aquestive Therapeutics, Inc. Employee Stock Purchase Plan, or ESPP, ~~in June 2018,~~ as amended and restated effective as of January 1, ~~2019. The Employee Stock Plan,~~2019, features two six-month offering periods per year, running from January 1 to June 30 and July 1 to December 31. Under the ESPP, employees may elect to purchase the Company’s common stock at the lower of 85% of the fair value of shares on either the first or last day of the offering period. During the ~~six months~~six-month periods ended June 30, 2020 and 2019, respectively, 14,961 and 31,393 shares were purchased ~~at a total discount of $20~~ and ~~were~~ issued ~~under~~through the ESPP ~~effective as~~at total discounts of ~~that date.~~$11 and $20.

Note 17. Income Taxes

~~Note 16.~~

~~Income Taxes~~

The Company has accounted for income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts and respective tax bases of existing assets and liabilities, as well as net operating loss carryforwards and research and development credits. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax asset will not be realized. The Company has considered the impact of the CARES Act in relation to the 2020 income tax provision. However, due to the full valuation allowance and no ability or intent to carryback the 2020 net operating loss, no impact is expected.

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The Company’s tax provision for interim periods is determined using an estimate of its annual effective tax rate, adjusted for discrete items. For the three months ended June 30, ~~2019~~2020 and ~~2018,~~2019, the Company recorded no income tax benefit from its pretax losses of ~~$20,472~~$2,334 and ~~$36,493,~~$20,472, respectively, and similarly for the ~~sixth~~six months ended June 30, ~~2019~~2020 and ~~2018,~~2019, the Company recorded no tax benefit from its pretax loss of ~~$35,198~~$18,864 and ~~$32,394,~~$35,198, respectively, due to realization uncertainties.

The Company’s U.S. Federal statutory rate is 21%. The primary factor impacting the effective tax rate for the ~~three~~three- and ~~six months~~six-month periods ended June 30, ~~2019~~2020 is the anticipated full year operating loss which will require full valuation allowances against any associated net deferred tax assets.

~~Note 17.~~

~~Commitments and~~Note 18. Contingencies

~~(A) Operating Leases~~

The Company has entered into various lease agreements for production and research facilities and offices. Most leases contain renewal options. Certain leases contain purchase options and require the Company to pay for taxes, maintenance and operating expenses. All of the Company’s leases are classified as operating leases.

Rent expense for all leased manufacturing facilities and sales, laboratory and office space totaled $399 and $292 for the three-month periods ended June 30, 2019 and 2018, respectively and $771 and $623 for the six-month periods ended June 30, 2019 and 2018, respectively.

~~(B)~~ Litigation and Contingencies

From time to time, the Company has been and may again become involved in legal proceedings arising in the ordinary course of business, including product liability, intellectual property, commercial litigation, or environmental or other regulatory matters. Except as described below, Aquestive is not presently a party to any litigation or other legal proceeding that is believed to be material to its financial condition.

Patent-Related Litigation

Beginning in August 2013, ~~we were~~the Company was informed of ~~ANDA~~abbreviated new drug application (“ANDA”) filings in the United States by Watson Laboratories, Inc. (now Actavis Laboratories, Inc., or “Actavis”), Par Pharmaceutical, Inc.(“Par”), Alvogen Pine Brook, Inc. (“Alvogen”), Teva Pharmaceuticals USA, Inc. (“Teva”), Sandoz Inc. (“Sandoz”), and Mylan Technologies Inc. (“Mylan”), for the approval by the FDA of generic versions of Suboxone Sublingual Film in the United States. ~~The Company~~Aquestive filed patent infringement lawsuits against all six generic companies in the ~~U.S.~~United States District Court for the District of ~~Delaware.~~Delaware (the “Delaware District Court”). After the commencement of the ANDA patent litigation against Teva, Dr. Reddy’s Laboratories (“DRL”) acquired the ANDA filings for Teva’s buprenorphine and naloxone sublingual film that are at issue in these trials.

Of these, cases against three of the six generic companies have been resolved.

Mylan and Sandoz settled without a trial. Sandoz withdrew all challenges and became the distributor of the authorized ~~generic.~~

generic products.

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 Patent No. 8,603,514, or the ~~‘514~~’514 patent, and cannot enter the market until the expiration of the patent in 2024, and the United States Court of Appeals for the Federal Circuit (“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.

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Subsequent to the above, all potential generic competitors without a settlement agreement were also sued for infringement of two additional new patents that contain new claims not adjudicated in the original Delaware District Court case against DRL and Alvogen. On July 12, 2019, the Federal Circuit affirmed the decisions from the previously decided cases. The remaining case against Actavis was dismissed in light of the infringement ruling above, which prevents Actavis from entering the market until 2024. The case(s) against the remaining defendants regarding the additional asserted patents have not been finally resolved. ~~The case~~A Markman hearing in the cases against ~~Actavis,~~Dr. Reddy’s and Alvogen which is pending in the ~~U.S.~~United States District Court for the District of ~~Delaware, is scheduled~~new Jersey (the “New Jersey District Court”) was held on October 17, 2019. On November 5, 2019, District Judge McNulty of the New Jersey District Court issued a Markman opinion construing the disputed terms of the asserted patents. On January 9, 2020, the New Jersey District Court entered a stipulated order of non-infringement of one of the patents, Patent No. 9,931,305, or the ’305 patent, based on the Federal Circuit’s claim construction ruling, and the Company and Indivior preserved available rights to appeal the claim construction ruling. On November 19, 2019, Magistrate Judge Waldor of the New Jersey District Court issued an order granting DRL and Alvogen’s requests to file amended answers to add antitrust counterclaims against Aquestive and Indivior. Aquestive and Indivior appealed the Magistrate Judge’s decision to District Judge McNulty on December 4, 2019, and DRL and Alvogen opposed the appeal. The parties are awaiting further action from the New Jersey District Court on the appeal. On January 17, 2020, the Company filed a motion to dismiss DRL’s and Alvogen’s antitrust counterclaims for ~~trial in December 2019.~~ failure to state a claim, and DRL and Alvogen opposed the motion. The parties are awaiting further action from the New Jersey District Court on the motion to dismiss. On June 3, 2020, the court issued an order setting a schedule for ongoing fact discovery, expert discovery, and dispositive motions. The schedule currently sets the close of fact discovery for October 20, 2020, with expert discovery continuing through the end of April 2021. The schedule also sets the deadline for filing dispositive motions for May 18, 2021. No trial date has been set in those cases. Management is not able to determine or predict the ~~cases against DRL and Alvogen, which are pending~~ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates, of the possible outcome or loss, if any, in ~~the U.S. District Court for the District of New Jersey.~~ this matter.

On February 19, 2019, the Federal Circuit issued its mandate reversing the New Jersey District ~~of New Jersey’s~~Court’s preliminary injunction against ~~DRL.~~Dr. Reddy’s. Following issuance of the mandate, the ~~District of~~ New Jersey District Court vacated preliminary injunctions against both ~~DRL~~Dr. Reddy’s and Alvogen. On February 19, 2019, Indivior launched the authorized generic of Suboxone Sublingual Film, which is manufactured by the Company exclusively for sale and marketing by Sandoz Inc., a sublicensee of Indivior. DRL,Dr. Reddy’s, Alvogen, and Mylan all launched generic versions of Suboxone Sublingual Film, and the launches by ~~DRL~~Dr. Reddy’s and Alvogen are “at risk” because the products are the subject of the ongoing patent infringement litigations.

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On March 22, 2019, Aquestive and Indivior brought suit against Aveva Drug Delivery Systems, Inc., Apotex Corp., and Apotex ~~Inc.~~Inc.in the United States District Court for the Southern District of Florida (the “Southern District of Florida Court”) for infringement of the ~~’150,~~Company’s U. S. Patent Nos. 8,017,150, 9,687,454, the ’514 ~~’454,~~patent and ’305 ~~patents,~~patent, seeking an injunction and potential monetary damages. Following a negotiated settlement between all parties, on December 3, 2019, the parties submitted a Notice of Settlement and a Joint Motion to Approve Consent Judgment. The ~~case is pending in the~~ Southern District of Florida ~~and~~Court entered an order dismissing the defendants filed their answers to the complaint, including counterclaims for non-infringement and invalidity of the asserted patents as well as two other patents that were not asserted in the original complaint.suit on December 18, 2019.

The Company is also seeking to enforce its patent rights in multiple cases against BioDelivery Sciences International, Inc. (“BDSI”). ~~Two~~Three cases are currently pending but stayed in the U.S. District Court for the Eastern District of North ~~Carolina:~~Carolina (the “Eastern District of North Carolina Court”):

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.~~8,475,832. This case is ~~stayed pending final resolution of the above-mentioned appeals on related patents.~~stayed.

The second was filed by usAquestive and Indivior related to BDSI’s infringing Bunavail product, and alleges infringement of ~~the Company’s~~Aquestive’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~~(4) IPR’s challenging the asserted ’167 patent. On March 24, 2016, the United States Patent Trial and Appeal Board ~~or the PTAB,~~(“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. WeThe parties in this matter are awaiting further action from the Court.

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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~~On August 7, 2019, ~~decisions on remand denying institution,~~ the ~~Company submitted a notice~~Eastern District of North Carolina Court granted BDSI’s motion to dismiss the ~~Court on February 15, 2019 notifying the Court that~~Complaint without prejudice and denied BDSI’s motion to stay ~~should be denied~~ as moot. On November 11, 2019, Aquestive filed a new Complaint against BDSI ~~also sent~~in the Eastern District of North Carolina Court. On November 27, 2019, BDSI filed a ~~letter~~motion to stay the ~~Court on February 13, 2019 indicating its intent to~~case pending BDSI’s appeal of the PTAB’s ~~decisions.~~remand decisions, and the Company opposed this motion. The ~~parties are awaiting further action from the Court. BDSI appealed~~Eastern District of North Carolina Court denied BDSI’s motion to stay on April 1, 2020. BDSI’s appeal of the PTAB’s remand decisions to the United States Court of Appeals for the Federal Circuit was docketed on March 13, 2019, and on March 20, 2019, ~~we moved~~and a motion was made to dismiss ~~the~~this appeal for lack of jurisdiction.

On August 29, 2019, the Federal Circuit granted the motion to dismiss BDSI’s appeal. On September 30, 2019, BDSI filed a petition for rehearing in the Federal Circuit en banc, which the Company opposed. The Federal Circuit denied BDSI’s petition for rehearing en banc on January 13, 2020. On June 11, 2020, BDSI filed a petition for writ of certiorari at the Supreme Court of the United States. The petition is scheduled for consideration at the Court’s September 29, 2020 conference, at which time the Court will decide whether to accept BDSI’s petition for review of the Federal Circuit’s dismissal of BDSI’s appeal. After the Federal Circuit denied BDSI’s petition, on January 13, 2020, BDSI filed with the Eastern District of North Carolina Court a motion to dismiss the Complaint, and Aquestive opposed on February 2, 2020. The Eastern District of North Carolina Court denied BDSI’s motion to dismiss and its motion to stay on April 1, 2020. On April 16, 2020, BDSI filed an Answer to the Complaint, including counterclaims for non-infringement, invalidity, and unenforceability of the ’167 patent. On May 7, 2020, Aquestive filed a motion to dismiss BDSI’s unenforceability counterclaim and a motion to strike BDSI’s corresponding affirmative defenses for failure to state a claim for inequitable conduct under the heightened pleading standard applicable to such claims and defenses. Rather than oppose Aquestive’s Motion to Dismiss, on May 28, 2020, BDSI amended its counterclaims and filed an Answer and Amended Counterclaims, which included additional allegations in support of BDSI’s unenforceability counterclaim. On June 25, 2020, Aquestive filed a Motion to Dismiss BDSI’s Amended Counterclaim for unenforceability and a Motion to Strike BDSI’s corresponding affirmative defense of unenforceability again for failure to state a claim under the applicable heightened pleading standard. BDSI’s filed its opposition to Aquestive’s Motion to Dismiss and Strike on July 16, 2020. Aquestive filed its Reply to BDSI’s Opposition on July 30, 2020.

Antitrust Litigation

On September 22, 2016, forty-one states and the District of Columbia, or the States, brought suit against Indivior and usthe Company in the U.S. District Court for the Eastern District of Pennsylvania, alleging violations of federal and state antitrust statutes and state unfair trade and consumer protection laws relating to Indivior’s launch of Suboxone Sublingual Film in 2010 and seeking an injunction, civil penalties, and disgorgement. After filing the suit, the case was consolidated for pre-trial purposes with the In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation, MDL No. 2445, or the Suboxone MDL, a multidistrict litigation relating to putative class actions on behalf of various private plaintiffs against Indivior relating to its launch of Suboxone Sublingual Film. While ~~the Company~~Aquestive was not named as a defendant in the original Suboxone MDL cases, the action brought by the States alleges that the Company participated in an antitrust conspiracy with Indivior in connection with Indivior’s launch of Suboxone Sublingual Film and engaged in related conduct in violation of federal and state antitrust law. ~~The Company~~Aquestive moved to dismiss the States’ conspiracy claims, but by order dated October 30, 2017, the Court denied ~~this~~the motion to dismiss. An answer was filed denying the States’ claims ~~was filed~~ on November 20, 2017. The fact discovery period closed on July 27, 2018, but the parties agreed to conduct certain fact depositions in August 2018. The expert discovery phase closed May 30, 2019, but additional reports and depositions ~~are being~~were conducted through August 1, 2019. ~~Summary judgement motions and~~ Daubert~~motions relating~~ briefing is ongoing. The remainder of the case schedule, including summary judgment briefing, is stayed pending resolution of Indivior’s appeal of the District Court’s class certification ruling in a co-pending multi-district litigation to ~~expert witnesses are due on September 26, 2019. At~~which the Company is not a party. On July 28, 2020, the U.S. Court of Appeals for the Third Circuit issued its opinion affirming the District Court’s order certifying the class. This ruling may result in a resumption of the pre-trial proceedings in this ~~time, management cannot~~case. Management is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates, of the possible outcome or loss, if any, in this matter.

~~Note 18.~~

~~Subsequent Event~~

~~Debt Refinancing & Warrant Issuance~~California Complaint

On ~~July 15,~~December 5, 2019, Neurelis Inc. (“Neurelis”) filed a complaint against Aquestive ~~Therapeutics, Inc. completed~~in the ~~private placement~~Superior Court of upCalifornia, County of San Diego alleging Unfair Competition, Defamation, and Malicious Prosecution related to ~~$100 million aggregate principal~~the Company’s pursuit of ~~its 12.5% Senior Secured Notes due 2025 (the “Notes”) and issued warrants~~FDA approval for ~~two million shares~~Libervant™. Neurelis filed a First Amended Complaint on December 9, 2019, alleging the same three causes of common stock (the “Warrants”), $.001 per value, through its structuring agent, Morgan Stanley & Co., LLC and entered into a purchase agreement and related indenture (the “Purchase Agreement” or “Indenture”) governing these Notes.action. The Company ~~simultaneously entered into related agreements including~~filed a ~~Collateral Agreement with U.S. Bank National Association as trustee and collateral agent, and~~Motion to Strike Neurelis’s Complaint under California’s anti-SLAPP (“strategic lawsuit against public participation”) statute on Friday, January 31, 2020, which Neurelis is expected to oppose. Neurelis filed a ~~Lien Subordination and Intercreditor Agreement~~motion for ~~the benefit of Madryn Health Partners, other institutional noteholders and U.S. Bank National Association in dual roles providing terms governing an asset-based loan facility.~~

~~Upon closing, the Company issued $70 million of the principal of the Notes (the “Initial Notes”) along with the Warrants and rights of first offer (the “First Offer Rights”)~~leave to the lenders participating in this transaction for Notes and Warrants (the “Lenders”). Issuance of the Initial Notes, Warrants and First Offer Rights has provided net proceeds of $66,951. In addition to the Initial Notes, the Indenture may provide access to further loans of up to $30,000 that may become available in two tranches of Additional Notes tied to the NDA filing for and FDA approval of Libervant, an important part of our drug candidate pipeline. Provided that no events of default exist, the Company may elect, subject to majority lenders’ approval, to offer to the Lenders participation infile a ~~$10,000 additional offering of 12.5% senior secured notes (the “First Additional Offering”) under terms similar to the Initial Notes,~~Supplemental Complaint on or before March 31, 2021, upon the filing of the Libervant NDA with the FDA. A second identical funding opportunity would allow, on or before March 31, 2021, the Company to obtain an additional $20,000 if the first option has been elected and funded, or, if not elected or funded, an additional $30,000 may be offered for issuance following FDA approval of Libervant. There can be no assurance that any such additional financingFebruary 5, 2020, which will be ~~consummated.~~opposed. On February 5, 2020, Neurelis filed a Motion for Leave to File a Supplemental Complaint (“Motion”). On June 5, 2020, Neurelis filed a Motion for Limited Discovery related to Aquestive’s anti-SLAPP motion.

1923

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~~Proceeds~~The court previously scheduled a hearing on both Aquestive’s anti-SLAPP Motion and on Neurelis’s Motion for April 24, 2020. However, on April 3, 2020, in response to the COVID-19 pandemic, the court issued an order continuing all hearings scheduled through April 30, 2020. The court ultimately held a telephonic status conference on June 25, 2020 to determine a schedule for hearing the pending motions. During that status conference, the court set Aquestive’s anti-SLAPP motion for hearing on July 24, 2020. The court also declined Neurelis’s request to hear its Motion and its Motion for Limited Discovery. Neurelis filed its response to Aquestive’s anti-SLAPP Motion on July 13, 2020, and we filed our reply on July 17, 2020. The parties are awaiting further action from ~~issuance~~the court regarding a new hearing date. Management is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates, of the Initial Notes and Warrants were used to fully repay the Company’s $52,092 outstanding indebtedness to Perceptive Credit Holdings, LP, related early repayment fees and legal and other fees incurred in executing this Indenture. Remaining proceeds of $14,859 will be used to support the advancement of Aquestive’s late-stage development pipeline, ongoing proprietary product commercialization and for general corporate operations.

The Notes provide a stated fixed rate of 12.5%, payable quarterly in arrears, with the initial quarterly principal repayment of the Initial Notes due on September 30, 2021 and the final quarterly payment due at maturity on June 30, 2025. Principal payments are scheduled to increase annually from 10% of the face amount of the debt then outstanding during the first four quarters to 40% of the initial loan principal during the final four quarters. Aquestive may elect, at its option, to prepay the Notes at any time at premiums that range from 101.56% of outstanding principal if prepayment occurs onpossible outcome or ~~after the 5~~^th anniversary of the issue date of the Notes to 112.5% if redemption occurs during the third year after the issuance of the Notes. In the event that redemption occurs within the two years after the issuance of the Notes, a make-whole fee is required, based on the present value of remaining interest payments using an agreed-upon discount rate linked to the then-current U.S. Treasury rate. The Indenture also includes change of control provisions under which the Company may be required to repurchase the Notes at 101% of remaining principal plus accrued interest at the election of the lenders.

Collateral for the loan consists of a first priority lien on substantially all property and assets, including intellectual property, of the Company. This secured obligation provides payment rights that are senior to all existing and future subordinated indebtedness of the Company and provides Lenders with perfected security interests in substantially all of the Company’s assets. In the event that asset-based loans of up to $10,000 may be obtained, subject receivables and inventory assets will provide a second priority lien to senior secured note holders. The Company’s license of its IP to a third-party drug development enterprise (specifically, Sunovion Pharmaceutical’s APL-130277 product) is one of the various assets serving as collateral for this loan. The loan indenture permits the Company to monetize this asset while specifying that a portion of the proceeds, up to $40,000 if the First Additional Offering has not been elected or funded, or, $50,000 if it has been elected and funded, must be applied to prepay the Initial Notes, at 112.5% of the principal amount of the Notes being repurchased, plus accrued and unpaid interest,loss, if any, thereon to the date of repurchase, to the extent elected by the Note holders, assuming that such monetization , up to such $40,000 or $50,000 level, as applicable, equals or exceeds those levels and if such monetization does not equal or exceed such level, such prepayment would be pro-rated among the Note holders. To the extent that lenders do not elect repayment of the debt at the date of monetization, the amount not elected up to $40,000 (or $50,000 with the first re-opener) will be held in ~~a collateral account until approval of Libervant by the FDA, at which time~~ this ~~cash collateral is to be released to the Company. Proceeds in excess of $40,000 (or $50,000 with the first re-opener) can be used immediately for general corporate purposes.~~matter.

Affirmative and negative covenants specified in the Indenture are considered typical for loans of this nature, including, but not limited to, specifications relating to preservation of corporate existence, publicly traded status, intellectual property and business interests; limitations or prohibitions of dividend payments or other dispositions, repurchases of shares, additional debt, certain equity issuances, asset transfers or dispositions, creation or occurrence of additional liens, entering into licensing or monetization arrangements other than as permitted under the Indenture, and perfection of security interests. Events of default include various commonly specified conditions, including but not limited to, bankruptcy, insolvency, material adverse changes, failure to meet Indenture payment or other obligations, compliance with regulatory requirements and preservation of the corporate existence and business operations.

The Warrants, expiring in June 2025, entitle the Lenders to purchase two million shares of the Company’s common stock, and include registration rights, specify an exercise price of $4.25 and a term of six years.

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Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read this section in conjunction with our unaudited condensed interim consolidated financial statements and related notes included in Part I Item 1 of this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related notes thereto and management’s discussion and analysis of financial condition and results of operations for the years ended December 31, ~~2018~~2019 and ~~2017~~2018 included in our ~~2018~~2019 Annual Report on Form 10-K. All dollar amounts are stated in thousands except for share data.

Forward-Looking Statements

This Quarterly Report on Form 10-Q and certain other communications made by us ~~includes~~include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions are intended to identify forward-looking statements.

These forward-looking statements may include, but are not limited to, statements regarding therapeutic benefits and plans and objectives for regulatory approvals of AQST-108, Libervant™ and our other product candidates; ability to obtain FDA approval and advance AQST-108, Libervant and our other product candidates to the market; statements about our growth and future financial and operating results and financial position, regulatory ~~approvals~~approval and pathways, clinical trial timing and plans, ~~the achievement~~our and our competitors’ orphan drug approval and resulting drug exclusivity for our products or products of ~~clinical and commercial milestones, product orders and fulfillment,~~our competitors; short-term and ~~longer term~~long-term liquidity and cash requirements, cash funding and cash burn, business strategies, market opportunities, ~~financing,~~ and other statements that are not historical facts. These forward-looking statements are also subject to the uncertain impact of the COVID-19 global pandemic on our business including with respect to our clinical trials including site initiation, patient enrollment and timing and adequacy of clinical trials, on regulatory submissions and regulatory reviews and approvals of our product candidates; pharmaceutical ingredients and other raw materials; supply chain, manufacture and distribution and sale of and demand for our products; our liquidity and availability of capital resources; customer demand for our products and services; customers’ ability to pay for goods and services; and ongoing availability of an appropriate labor force and skilled professionals. Given these uncertainties the Company is unable to provide assurance that operations can be maintained as planned prior to the COVID-19 pandemic.

These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and clinical ~~trials; the risks~~trials and plans; risk of delays in FDA approval of Libervant and our other drug candidates or failure to receive approval; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of the FDA regulations of our drug candidate Libervant relative to FDA-approved diazepam rectal gel and nasal spray products, including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product of a competitor in the U.S. and there can be no assurance that we will be successful; risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any other drug products for which we are seeking FDA approval and that such earlier approved competitor orphan drug blocks such other product candidates in the U.S. for seven years for the same indication; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risks and uncertainties concerning any potential monetization of royalty and other revenue streams, including from Kynmobi, including timing, structure, terms and market conditions of any such monetization, and of sufficiency of net proceeds of any such monetization after satisfaction of and compliance with 12.5% Senior Notes obligations, as applicable; risk of development of our sales and marketing capabilities; risk of legal costs associated with and the outcome of our patent litigation challenging ~~third party~~third-party at risk generic sale of our proprietary products; risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and ~~longer term~~longer-term cash requirements and other cash needs, at the times and in the amounts needed; risk of ~~availability of refinancing of existing debt facilities; risk of~~ failure to satisfy all financial and other debt covenants and of any ~~default under our senior secured notes;~~default; risk related to government claims against Indivior for which we license, manufacture and sell ~~Suboxone~~Suboxone® and which accounts for the substantial part of our current operating revenues; risk associated with Indivior’s cessation of production of its authorized generic buprenorphine naloxone film product, including the impacts from loss of orders for the authorized generic product and risk of eroding market share for Suboxone and risk of sunsetting product; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance of our ~~products~~product and product candidates; the success of any competing products, including generics; risk of the size and growth of our product markets; ~~risk of the effectiveness and safety of our products and product candidates; risk~~risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory ~~action~~actions affecting pharmaceutical product pricing, reimbursement or access; claims and ~~concerns~~risks that may arise regarding the safety or efficacy of the Company’s products and product candidates; risk of loss of significant customers; risks related to legal proceedings including patent infringement, investigative and antitrust litigation matters; changes in ~~governmental~~government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other ~~risks and~~ uncertainties affecting the Company ~~including those~~ described in the “Risk Factors” section and in other sections included in ~~the Company’s~~our Annual Report on Form ~~10‑K~~10-K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the ~~SEC on March 14, 2019 and in our quarterly reports on Form 10-Q.~~Securities Exchange Commission (SEC). Given ~~these~~those uncertainties, you should not place undue reliance on these forward-looking statements, which ~~address matters~~speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements, or outlook or guidance, after the date of this ~~report~~Quarterly Report on Form 10-Q whether as a result of new information, future events or otherwise, except as may be required by applicable law. Readers should not rely on the forward-looking statements included in this Quarterly Report on Form 10-Q as representing our views as of any date after the date of the filing of this Quarterly Report on Form 10-Q.

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Overview

We are a ~~specialty~~ pharmaceutical company focused on developing and commercializing differentiated products ~~with~~which leverage our proprietary PharmFilm® technology to meet patients’ unmet medical needs and to solve patients’ therapeutic ~~problems to address unmet medical needs.~~problems. Following the Company’s Initial Public Offering (“IPO”) in July 2018, the Company’s common stock trades on the Nasdaq Global Market under ticker symbol “AQST”. We have three commercial products, ~~on the market,~~ including one ~~that is~~ proprietary product and two out-licensed products, another FDA-approved product that ~~are~~has been out-licensed for commercialization in European markets following applicable regulatory approvals, as well as a late-stage proprietary product pipeline focused on the treatment of central nervous system, or CNS, ~~diseases.~~diseases and an earlier stage pipeline including treatment of anaphylaxis. We have also licensed certain intellectual property rights for use in development and commercialization of oral films containing apomorphine, which were granted FDA approval on May 21, 2020 and are used for the treatment of off episodes in patients suffering from Parkinson’s disease. We believe that our products address the characteristics of these patient populations and the shortcomings of available treatments create opportunities for the development and commercialization of meaningfully differentiated medicines.

Sympazan® (clobazam), an oral ~~soluble~~ film ~~formulation~~for the treatment of ~~clobazam used as an adjunctive therapy for~~ seizures associated with a rare, intractable form of epilepsy known as Lennox-Gastaut ~~Syndrome,~~syndrome, or LGS, was approved by the FDA on November 1, 2018. The Company commercially launched Sympazan in December 2018. Sympazan was launched as a precursor and complement to our product candidate Libervant and continues to progress on key performance metrics including prescriber growth, repeat prescribers, quarterly growth in retail shipments, and covered lives.

21Exservan®, utilizing our proprietary PharmFilm® technology, has been developed for the treatment of amyotrophic lateral sclerosis (ALS). Exservan was approved by the FDA on November 22, 2019. During the fourth quarter of 2019, we announced the granting of a license to Zambon S.p.A. for the development and commercialization of Exservan Oral Film in the European Union (EU) for treatment of ALS. Zambon is exclusively responsible for obtaining regulatory approval and marketing Exservan in the EU and we have sole and exclusive manufacturing rights for the product in the EU. We are seeking an appropriate licensee for the commercialization rights for Exservan in the United States. There can be no assurance that we will be successful in licensing Exservan in the United States.

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~~Our~~Libervant is our most advanced proprietary investigational product ~~candidates include:~~

~~Libervant™,~~candidate, which we intend to self-commercialize, subject to FDA approval for market access in the U.S. Libervant is a ~~buccal~~buccally, or inside of the cheek, administered soluble film formulation of ~~diazepam used~~diazepam. Aquestive is developing Libervant as an alternative to the device-dependent rescue therapies currently available to patients with refractory epilepsy, which are a ~~rescue therapy~~rectal gel and newly approved nasal sprays. The Company filed an NDA for ~~breakthrough epileptic seizures~~Libervant in November 2019 and ~~an adjunctive therapy for use~~the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020. A competitive nasal spray product with seven-year orphan drug U.S. marketing exclusivity was approved in ~~recurrent convulsive seizures, for which a pre-NDA meeting was held~~January 2020. We continue to engage in ~~December 2018~~interactions with the ~~FDA. The meeting resulted in a plan~~FDA related to ~~complete a small single-dose crossover study comparing~~our accepted NDA for Libervant, including providing information to the ~~reference listed drug, Diastat®. This study was initiated~~agency, responding to information requests and working with the agency on inspections of our manufacturing and clinical investigational sites. We are seeking to demonstrate that Libervant will, if approved by the FDA for marketing access in the ~~first quarter~~U.S., represent a “major contribution to patient care” within the meaning of ~~2019,~~FDA regulations 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~~guidance, as compared 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~~available treatment ~~of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDA in~~options, as the first, ~~quarter of 2019;~~non-device delivered, oral diazepam-based product available to manage seizure clusters in epilepsy patients. However, overcoming the ~~PDUFA goal date~~orphan drug marketing exclusivity is difficult to establish, with limited precedent, and there can be no assurance that the FDA will agree with our position seeking to overcome such marketing exclusivity and approve Libervant for ~~FDA approval is November 30, 2019.~~

U.S. marketing access.

We have also developed a proprietary pipeline of complex molecule-based products addressing market opportunities beyond CNS indications, which include:

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AQST-108, a “first of its kind” oral sublingual ~~soluble~~ film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies. Epinephrine is the standard of care for the treatment of anaphylaxis and ~~severe allergic reactions, which~~ is ~~intended~~currently administered via subcutaneous or intramuscular injection. The current market leader is EpiPen®, a single-dose, pre-filled automatic injection device. As a result of its administration via subcutaneous or intra-muscular injection, many patients and their caregivers are reluctant to ~~provide~~use currently available products, resulting in increased hospital visits and overall cost of care to treat anaphylactic events. The data from the previously completed Phase I dose escalation study demonstrated that AQST-108 achieved similar ranges of mean values of maximum concentration (Cmax) and time to reach maximum concentration (Tmax) to that reported for injectables EpiPen and another injection device, Auvi-Q®, provided a greater total exposure (AUC0-t; area under the curve) than that reported for EpiPen and Auvi-Q, had less interpatient variability when compared to degree of variation (CV%) data reported for EpiPen and Auvi-Q, and was well tolerated, with no study participants discontinuing participation due to an ~~adjunct~~adverse event. We believe that, as a result of its sublingual administration, AQST-108 will improve patient compliance and ~~or alternative~~lower the total cost of care. After a constructive face-to-face pre-IND meeting with the FDA in early February 2020, the Company submitted an IND for AQST-108, as expected, to ~~injection treatments such as EpiPen. After~~ the ~~Company’s first human proof of concept trials, a re-formulated~~FDA on June 26, 2020. The FDA confirmed that the drug candidate will be reviewed under the 505(b)(2) regulatory approval pathway, and ~~more advanced prototype~~that no additional studies will be necessary prior to opening the IND application. The IND has been ~~developed, for which we began additional phase 1 proof of concept~~reviewed and was accepted by the FDA on July 23, 2020. We expect to initiate PK clinical trials ~~early in~~during the ~~second~~third quarter of ~~2019;~~2020 in a crossover study to compare the pharmacokinetics and

pharmacodynamics of epinephrine administration as sublingual film to that of epinephrine administration as an injection, subject to any delays resulting from the COVID-19 pandemic.

AQST-305 is a sublingual ~~soluble~~ film formulation of octreotide, a small peptide that has a similar pharmacological profile to natural somatostatin, for the treatment of acromegaly, as well as severe diarrhea and ~~neuroendocrine tumors. As~~flushing associated with carcinoid syndrome. Acromegaly is a hormone disorder that results from the overproduction of growth hormone in middle-aged adults. Octreotide is the standard of care for the treatment of acromegaly. The current market leader, Sandostatin®, is administered via deep subcutaneous or intramuscular injections once a month. This monthly treatment regimen can result in loss of ~~early stage clinical~~efficacy toward the end of the monthly treatment cycle. We are developing AQST-305 as a non-invasive, pain-free alternative to Sandostatin to reduce treatment burden, healthcare costs and the potential loss of efficacy of the treatment cycle. AQST-305 has shown promising preclinical and human proof of concept ~~studies, re-formulation~~results. While we focus our efforts on Libervant and AQST-108 this year, limited formulation work is ~~currently underway.~~being done to prepare AQST-305 for additional research trials.

The COVID-19 pandemic may adversely impact the expected timelines for our clinical trials and studies and could contribute to delay in obtaining regulatory review and approval for our product candidates.

In addition to these product candidates, we have a portfolio of commercialized and development-stage licensed products. Our largest commercialized licensed product to date is Suboxone, a sublingual film formulation of buprenorphine and naloxone, for the treatment of opioid dependence. We have a sole and exclusive worldwide manufacturing agreement with Indivior to deliver ~~both the~~Suboxone.

In early 2019, certain third-party pharmaceutical companies launched, at risk, generic film products for buprenorphine-naloxone. As of mid-July 2020, Suboxone branded ~~Suboxone, globally through~~products retain approximately 40% of film market share as generic film-based products have penetrated this market. Indivior accounted for 48% and ~~the authorized generic sublingual film formulation~~86% of ~~buprenorphine and naloxone, through Sandoz~~our total revenues for the ~~United States market. As~~six-month periods ended June 30, 2020 and 2019, respectively. Our total revenue mix is expected to shift to a higher proportionate share of ~~July 2019, these~~proprietary product sales in future years as we continue to grow Sympazan revenues and pursue the launch of other products ~~account for greater than 75% of the oral film products prescribed~~ in ~~the U.S. for recovery from opioid addiction – a market that continues to grow.~~our pipeline, assuming FDA approvals.

We manufacture all of our licensed and proprietary products at our FDA- and DEA-inspected ~~facilities. There~~facilities and anticipate that our current manufacturing capacity is ~~no guarantee that proprietary or licensed~~sufficient for commercial quantities of our products ~~will necessarily be manufactured by the Company.~~and product candidates currently in development. We have produced over 2 billion doses of Suboxone ~~and other commercial non-pharmaceutical~~since 2006. Not all collaborative or licensed products ~~for all customers since 2006.~~of the Company that may be commercially launched in the future will necessarily be manufactured by the Company, such as Kynmobi. Our products are developed using our proprietary PharmFilm® technology and know-how.

~~On July 27, 2018, we closed the initial public offering (“IPO”)~~ The COVID-19 pandemic could negatively impact our continued commercialization of Sympazan, impact demand for our approved products and ~~on August 15, 2018, the underwriter’s overallotment option was exercised. A total~~development and commercialization of ~~4,925,727 shares of common stock were issued. On July 25, 2018, the Company began trading on the Nasdaq Global Market under ticker symbol “AQST”. The offering and overallotment resulted~~other products in aggregate gross proceeds of $73,886 before underwriting discounts and other costs and expenses of the offering. Total net proceeds to Aquestive after underwriters’ discounts and other costs and expenses of the IPO totaled $63,482.our pipeline.

On July 15, 2019, we completed a private placement of $70,000 of 12.5% Senior Secured Notes due June 2025 (“Notes” or “Senior Secured Notes”) and ~~unregistered~~ warrants ~~and paid off our existing credit facility. The new~~for the purchase of up to 2 million common shares, against which 428,571 common shares were issued in December 2019 upon exercise. This financing provided net proceeds of ~~$66,951~~$66,056 after all offering expenses. The net proceeds of the financing were used to repay all outstanding obligations under the Company’s prior credit facility of ~~$52,092.~~$52,944. We ~~intend to use~~used the remaining ~~balance~~net cash proceeds of ~~$14,859~~$13,110 for the continued commercialization and advancement of our proprietary products and pipeline candidates, and other general corporate purposes. Our Senior Secured Notes are discussed in Note ~~18, Subsequent Event,~~13, 12.5% Senior Secured Notes, to our ~~Consolidated Financial Statements~~condensed consolidated financial statements included herein and in Liquidity and Capital Resources.

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On September 11, 2019, we filed with the SEC a Registration Statement on Form S-3, which was declared effective on September 17, 2019 (File No. 353-233716) (the “S-3 Registration Statement”). Under the S-3 Registration Statement we may sell up to $150 million of our securities including, without limitation, common stock, preferred stock, warrants, and debt securities. On September 11, 2019, we entered into an equity distribution agreement to offer shares of our common stock from time to time in an “at-the-market" offering. We may offer and sell shares of common stock for an aggregate offering price of $25.0 million. No shares have been sold pursuant to this “at-the-market" offering as of the date of this report. The equity distribution agreement does not have an expiration date but can be canceled by us at any time for convenience with 10 days written notice. On December 12, 2019, we sold 8,050,000 common shares for gross proceeds of $40,250 in an underwritten public offering under the S-3 Registration Statement that netted $37,295 after the underwriter discount and offering costs. We have also reserved under the S-3 Registration Statement up to an additional 4,222,082 shares of our common stock for sale by our stockholders and for the exercise of warrants held by the holders of our Senior Secured Notes, of which 428,571 shares have been sold. Under our S-3 Registration Statement we are subject to, among other requirements applicable to our continuing eligibility to offer and sell securities pursuant to that short-form registration statement, the “baby shelf” registration requirements which may limit the amounts available under the registration statement if our public float falls below certain minimum levels at the time of filing our Annual Report on Form 10-K. At this time, the Company is not subject to such limitation.

We generated ~~revenue~~revenues of ~~$11,129~~$30,440 and ~~$13,928~~$23,772 for the ~~three months~~respective six-month periods ended June 30, ~~2019~~2020 and ~~2018, respectively,~~2019. These revenues were derived from manufacturing and ~~$23,772 and $37,339 for the six months ended June 30, 2019 and 2018, respectively, most significantly~~supply revenues from commercial products licensed to our ~~marketing~~collaboration or commercialization licensees. Total revenues also included ~~manufacturing~~licensing, royalty and ~~supply revenue, license fees, royalties,~~ co-development and research fees and our proprietary product sales. Our licensing and royalty revenue is subject to the normally uneven nature of the timing of ~~co-development and~~ licensing milestone payments and to the product volumes ~~of product~~and sales revenues realized by our licensees ~~sell on the market~~ from which we receive ~~royalties and manufacturing revenues.~~royalties. Suboxone, which was launched in 2010, was our first licensed pharmaceutical product to be commercialized, and we have other licensing relationships that contribute to our revenue and future revenue opportunities. Sympazan, which was launched in December 2018, is the first proprietary pharmaceutical product commercialized directly by the Company.

As of June 30, ~~2019,~~2020, we had ~~$22,165~~$25,422 in cash and cash equivalents. As a result of ~~net losses incurred~~our investments in product development, recent investments in commercialization initiatives, share-based compensation expenses surrounding the ~~operations~~2018 initial public offering, among other expenses and legal and other expenses related to patent procurement, protection and prosecution and other matters, as of ~~the Company during the first six months of 2019,~~June 30, 2020, we had an accumulated deficit of $149,338 resulting in a net shareholders’ deficit of ~~$24,657. We incurred net losses~~$21,388 as of ~~$20,472 and $36,493 for~~that date. For the ~~three months~~six-month periods ended June 30, ~~2019~~2020 and ~~2018, respectively. For the six months ended June 30,~~ 2019, ~~and 2018,~~ we incurred net losses of $18,864 and $35,198, ~~and $32,394,~~ respectively. ~~Our working capital, inclusive of cash and cash equivalents, at June 30, 2019 was $14,435.~~

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We expect to continue to incur net losses ~~and negative operating cash flow~~ for at least the ~~foreseeable future~~next few years as we pursue the development, commercialization and marketing of our proprietary product candidates. Our net losses may fluctuate significantly from period to period, depending on regulatory approval developments concerning both our late-stage and earlier stage product candidates, the timing of our planned clinical trials and expenditures on our other research and development, ~~activities,~~ as well as our commercialization activities. ~~Our~~We expect our expenses ~~may fluctuate substantially~~will continue to be substantial in 2020 and future periods over time as ~~we:~~

~~fund commercialization investments for Sympazan (launched in December 2018) and,~~we continue to, 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~~any delay as a result of the coronavirus pandemic:

focus on the approval of Libervant for marketing in the U.S. and, subsequently, if approved, which we cannot assure, its commercialization,

clinically develop AQST-108 along the 505(b)(2) pathway with PK clinical trials expected to begin in the third quarter of 2020, subject to any delay from the coronavirus pandemic, and

grow Sympazan sales as a precursor and complement to an eventual launch of ~~proprietary products~~Libervant, if approved.

We expect to continue to manage the timing and level of expenses in light of the declining revenues related ~~growth.~~

to Suboxone, offset in part by the revenue contribution from Sympazan, while focusing on the development and commercialization of Libervant and AQST-108, if approved by the FDA.

Our business has been financed through a combination of revenue from licensed product and proprietary product activities, proceeds from our IPO and other equity ~~investments from our stockholders~~issuances and ~~debt~~ proceeds from our ~~credit facilities~~debt instruments and facilities. Significant additional funding is expected to be required in order to execute our business strategy and operations.

Until we become profitable, if ever, we expect to need to raise significant additional capital in the future through equity or debt issuances, or both, and to continue to manage our expenses to extend our capital runway, in order to further the development, regulatory approval, commercialization and marketing of our products and product candidates, and to conduct our business. We have no committed sources of additional capital, and there can be no assurance that such needed capital will be available on favorable terms, or at all. We may seek to obtain additional capital in the future through the issuance of our common stock, through other public or private equity or debt financings, through potential non-dilutive capital raising events that may result from royalty streams that may be realizable from our licensed products or licensed intellectual property, and through collaborations or licensing arrangements with other companies or other means, if available. We may not be able to raise additional capital or other funding on terms acceptable to us, or at all, and any failure to raise capital as and when needed could compromise our ability to execute our business plan and cause us to delay or curtail our operations until such funding is received. To the extent that we raise additional funds by issuance of equity securities, our stockholders would experience dilution, and other debt financings, if available (and subject to all of the existing restrictions and conditions under the Indenture for the Senior Secured ~~Notes. Our new 12.5% Senior Secured Notes due 2025~~Notes) may involve increased restrictive covenants and ~~unregistered Warrants issued on July 15, 2019, are discussed in Note 18, Subsequent Event,~~increased fixed payments or may otherwise further constrain our financial flexibility. Any potential monetization transaction is subject to acceptable timing, structure and terms and to acceptable market conditions. To the extent that we raise additional funds through collaborative or licensing arrangements, it may be necessary to relinquish some rights to our ~~Consolidated Financial Statements~~intellectual property or grant licenses on terms that are not favorable to us. In addition, payments made by potential collaborators or licensors generally will depend upon our achievement of negotiated development and regulatory milestones. Failure to achieve these milestones may harm our future capital position. See “Funding Requirements” below for additional information regarding Aquestive’s cash needs.

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Business Update Regarding COVID-19

The current COVID-19 pandemic has presented substantial health and economic risks, uncertainties and challenges to our business, the U.S. and global economies and financial markets. It is not currently possible to predict how long the pandemic will last or the time it will take for the economy to return to prior levels. The extent to which COVID-19 impacts our business, operations, clinical trials, regulatory approval process, capital, financial and monetization markets, financial results and financial condition, and those of our suppliers, distributors, customers and other third parties necessary to our business including those involved in ~~Liquidity~~the regulatory approval process, will depend on future developments, which are highly uncertain and ~~Capital Resources. The Warrants include an obligation~~cannot be predicted with certainty or clarity, including the duration and continuing severity of the ~~Company to use reasonable best efforts to register the Warrant Shares for resale with the Securities and Exchange Commission within 90 days~~outbreak, resurgence of the ~~closing~~outbreak, continued or additional government actions to contain COVID-19, timing or efficacy of any vaccine, and ~~grant customary piggy-back rights~~new information that will emerge concerning the short-term and long-term impact of COVID-19.

To date, we have been able to ~~Warrant holders. As~~continue to manufacture and supply our products and currently do not anticipate any significant interruption in supply, although we continue to monitor this situation closely and there is no assurance that disruptions or delays may not occur as a result of COVID-19. We are also monitoring demand for our products, which could be negatively impacted during the ~~requirement to register~~COVID-19 pandemic, as well as the ~~shares, we will register the warrants and affiliate shares as part~~financial condition of our ~~Universal Shelf Registration that we expect~~customers and licensees, one of whom delayed remittance of certain payments due the Company for development services provided but ultimately made such payments in later Q2 2020.

Our office-based employees have generally been working from home since mid-March 2020, while essential staffing levels in our operations remain on site, and personnel have continued in our laboratories and manufacturing locations. We suspended in-person interactions by our sales and marketing personnel and engaged remotely to ~~file later~~support our commercialization efforts. Sales and marketing practices continue to evolve in accordance with changing local rules and regulations with in-person interactions increasing in recent weeks as restrictions were easing. However, the landscape continues to change as new case rates are rising in certain states and localities and these jurisdictions have or are contemplating reestablishing restrictions. We are expecting to commence our AQST-108 PK clinical trials during the third quarter of ~~2019. The Shelf Registration Statement provides increased capital flexibility as~~2020, although the COVID-19 precautions could directly or indirectly impact timelines, which we will continue to ~~execute our business plan. We do not at this time have any current plans to access the equity capital markets.~~monitor and assess.

~~Aquestive is subject to the same risks common to companies in similar industries and stages of development, including, but not limited to, competition from larger companies, reliance~~For additional information on a very limited number of products and services and dependence on a single customer for the substantial majority of our current revenues, expected incurrence of operating losses and negative operating cash flows for the foreseeable future, reliance on future uncommitted funding sources, which cannot be assured, to satisfy short-term and longer term liquidity and cash requirements, reliance on a single manufacturing site, new technological innovations, dependence on key personnel, reliance on third-party service providers and sole source suppliers, protection of proprietary technology, compliance with government regulations, dependency on the clinical and commercial success of our drug candidates, ability to obtain regulatory approval of our drug candidates, including Libervant, uncertainty of broad adoption of the recently-launched Sympazan or other approved products, if any, by payers, physicians, and consumers, significant competition, untested manufacturing capabilitiesvarious uncertainties and risks ~~related to cybersecurity.~~caused by the COVID-19 pandemic, see Part II, Item 1A, Risk Factors included in this report.

Critical Accounting Policies and Use of Estimates

See Note 3, Summary of Significant Accounting Policies, to our ~~Consolidated Financial Statements,~~condensed consolidated financial statements, included herein for a discussion of recently issued accounting pronouncements and their impact or future potential impact on our financial results, if determinable. For a discussion of critical accounting policies that affect our judgments and estimates used in the preparation of our consolidated financial statements, refer to “Critical Accounting Policies and Use of Estimates” in our ~~2018~~2019 Annual Report on Form 10-K.

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JOBS Act

On April 5, 2012, the Jumpstart Our Business Startups Act, or the JOBS Act, was enacted. The JOBS Act provides that, among other things, an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. As an emerging growth company, we have elected to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards and, as a result, we ~~expect to~~will comply with new or revised accounting standards nonot later than on the relevant dates on which adoption of such standards is required for emerging growth companies.

In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS ~~Act. Subject~~Act, subject to certain conditions ~~set forth in the JOBS Act,~~contained therein and, as ~~an “emerging growth company”,~~a result, we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, ~~and~~ (ii) provide all of the compensation disclosure that ismay be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection ~~Act.~~Act, or (iii) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation. These exemptions will apply for a period of five years following the consummation of our IPO or until we no longer meet the requirements of being an emerging growth company, whichever is earlier.

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We are also a “smaller reporting company,” meaning that we are not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent company that is not a “smaller reporting company,” and have either: (i) a public float of less than $250 million or (ii) annual revenues of less than $100 million during the most recently completed fiscal year and (A) no public float or (B) a public float of less than $700 million. As a “smaller reporting company,” we are subject to reduced disclosure obligations in our SEC filings compared to other issuers, including with respect to disclosure obligations regarding executive compensation in our periodic reports and proxy statements and certain reduced financial disclosures in our periodic reports.

Financial Operations Overview

Revenues

Our revenues to date have been earned from manufactured products made to order for licensees, including Suboxone and Zuplenz, as well as revenue from our ~~commercialized partnered products, licensing and royalty initiatives,~~self-developed, self-commercialized proprietary product, Sympazan. Revenues are also earned from our product development ~~initiatives for third parties and sales of self-developed medicines.~~services provided under contracts with customers. These activities generate revenues in four primary categories: manufacturing and supply revenue, co-development and research fees, license and royalty revenue, and proprietary product sales, net.

Manufacture and Supply Revenue

Currently, we produce two licensed commercialized pharmaceutical products: Suboxone and Zuplenz. We are the exclusive manufacturer for these products. We manufacture based on receipt of purchase orders from our licensees, and our licensees have an obligation to accept these ~~filled~~ orders once quality assurance validates ~~the quality~~compliance of the manufactured ~~product.~~product with agreed upon technical specifications. Under ASC 606, we record revenues once the manufactured product passes quality ~~control.~~control inspections. Our licensees are responsible for all other aspects of commercialization of these products and the Company has no role, either direct or indirect, in ~~or ability~~our customers’ commercialization activities, including those related to ~~participate in commercialization including~~ marketing, pricing, sales and regulatory ~~strategy.~~operations.

We expect future manufacture and supply revenue from licensed ~~activities~~products to be based on volume demand for existing licensed products, and for manufacturing and supply rights under license and supply agreements for existing or new ~~collaborations~~agreements for successful product development ~~and additional licensing of our intellectual property.~~collaborations.

Co-development and Research Fees

We work with our licensees to co-develop pharmaceutical products. In this regard, we earn fees through performance of specific tasks, activities, or completion of stages of development defined within a contractual arrangement with the relevant licensee. The nature and extent of these performance obligations, broadly referred to as milestones or deliverables, are usually dependent on the scope and structure of the project as contracted, as well as the complexity of the product and the specific regulatory approval path necessary for that product.

License and Royalty Revenue

~~Once a viable product opportunity is identified~~We may realize licensing revenue from transfers of our ~~co-development and research~~licenses. For licenses that do not require further development or other ongoing activities ~~with~~by us, our ~~licensees, we may out-license~~licensee has acquired the right to ~~our licensees~~use the ~~rights to utilize our~~licensed intellectual property for self-development of their product candidate, for manufacturing, commercialization or other specified purposes upon the effective transfer of those rights, and related revenues are generally recorded at a point in time, subject to ~~their marketing~~contingencies or constraints, if any. For licenses that may provide substantial value only in conjunction with other performance obligations to be provided by us, such as development services or the manufacture of ~~such products. As a result, we earn revenue from~~specific products, revenues are generally recorded over the term of the license ~~fees received under such license, development and supply agreements.~~ agreement. We also may earn royalties based on our licensees’ sales of products that use our intellectual property that are marketed and sold in the countries where we have patented technology rights.

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Proprietary Product Sales, net

As we commercialize ~~our~~FDA approved proprietary CNS product candidates, ~~beginning with Sympazan, as well as Libervant, subject to regulatory approval,~~ we ~~expect to~~may directly ~~market our~~sell such products to ~~consumers~~distributors of wholesale medical products in the United States, resulting in an additional and growing source of ~~revenue which we refer to as Proprietary Product Sales.~~revenue. We commercialized our first proprietary CNS product, Sympazan, in December 2018. We currently sell Sympazan through wholesalers for distribution ~~primarily~~ through retail pharmacies. Additionally, we may choose to ~~select~~access non-domestic markets by contracting with a collaborator to commercialize our product candidates in certain ~~markets inside and outside of the United States.~~foreign markets. To date, the only revenue generated from our self-developed and self-commercialized pharmaceutical products is from the sale of Sympazan in the United States.

Revenues from sales of ~~products~~proprietary product are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, rebates and co-pay ~~card~~support redemptions, each of which are described in more detail ~~below.~~in our 2019 Annual Report on Form 10-K. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. These amounts are treated as variable consideration, estimated and recognized as a reduction of the transaction price at the time of the sale. The Company ~~includes~~records these estimated amounts in connection with the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized for such transaction will not occur, or when the uncertainty associated with the variable consideration is resolved. The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts and other related information that may become known in the future. The adequacy of these provisions is reviewed on a quarterly basis.

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~~Prompt Pay Discounts~~

The prompt pay reserve is based upon discounts offered to wholesalers as an incentive to meet certain payment terms. We accrue discounts to wholesalers based on contractual terms of agreements. We account for these discounts at the time of sale as a reduction to gross product sales and a reduction to accounts receivable.

~~Wholesaler Service Fees~~

Our customers include major national and regional wholesalers with whom we have contracted a fee for service based on a percentage of gross product sales. This fee for service is recorded as a reduction to gross product sales and an increase to accrued expenses at the time of sale and is recorded based on the contracted percentage.

~~Returns Allowances~~

We allow customers to return product that is damaged or received in error. In addition, we allow Sympazan to be returned beginning six months prior to, and twelve months following, product expiration. We estimate our sales returns reserve based on industry averages until such time that we have accumulated enough data to apply a historical trend analysis. The returns reserve is recorded at the time of sale as a reduction to gross product sales and accounts receivable.

~~Rebates~~

Rebates include third party Managed Care and Medicaid rebates, and Medicare Part D rebates and other government rebates. Rebates are accrued based upon an estimate of claims to be paid for product sold into trade by the Company. The provisions for government rebates was based in part by contractual terms and government regulations. We monitor legislative changes to determine what impact such legislation might have on our Company. We account for these deductions as a reduction of gross products sales and an increase in accrued expenses.

~~Co-Pay Cards~~

Co-pay card redemptions costs represent the costs to help offset a customer’s co-pay or cover a predetermined amount of prescription based on business rules. We account for these deductions as a reduction of gross product sales and an increase in accrued expenses.

Costs and Expenses

Our costs and expenses are primarily the result of the following activities: generation of manufacture and supply revenues; development of our pipeline of proprietary product candidates; and selling, general and administrative expenses, including pre-launch and ~~post-launch~~post launch commercialization efforts related to our CNS product candidates, intellectual property procurement, protection, prosecution and litigation expenses, corporate management functions, medical and clinical affairs administration, public company costs, share-based compensation expenses and interest on our corporate borrowings. We primarily record our costs and expenses in the following categories:

Manufacture and Supply Costs and Expenses

Manufacture and supply costs and expenses are ~~comprised~~ primarily incurred from the manufacture of ~~costs and expenses related to manufacturing~~ our ~~proprietary dissolving film products for our marketed~~commercialized licensed pharmaceutical products and for our ~~newly~~self-developed, self-commercialized approved proprietary ~~products~~product, including raw materials, direct labor and ~~fixed~~ overhead costs, principally in our Portage, Indiana facilities. ~~In 2019, we expect the costs of our proprietary products manufactured to be a greater factor in these expenses, but such costs were minimal in 2018.~~ Our material costs include the costs of raw materials ~~other than the API component of Suboxone,~~ used in the production of our proprietary dissolving film and primary packaging materials. Direct labor costs consist of payroll costs (including taxes and benefits) of employees engaged in production activities. ~~Fixed and semi-fixed overhead~~Overhead costs principally ~~consists~~consist of indirect payroll, facilities rent, utilities and depreciation for leasehold improvements and production machinery and equipment.

Our manufacture and supply costs and expenses are impacted by our customers’ supply requirements. Costs of production reflect the costs of raw materials that are purchased at market prices and production efficiency (measured by the cost of a salable unit). These costs can increase or decrease based on the costs of materials, purchased at market pricing, and the amount of direct labor ~~and materials~~ required to produce a product, ~~and~~along with the allocation of fixed overhead, which is dependent on ~~the levels of production.~~production volume.

We expect to continue to seek to rationalize and manage costs to reflect the declining production volumes of Suboxone. Our unit production costs of manufacturing and supply increased in late 2019, resulting from the declining volume of Suboxone that began in 2019 and that continues to decline in 2020. We expect our manufacture and supply ~~costs and~~ expenses to ~~increase~~decrease over the next several years due to the ~~commercialization~~effects of lower Suboxone volume caused by competing generic products, modestly offset by the costs to manufacture our proprietary products, which began with the launch of Sympazan ~~launched~~ in December ~~2018 and~~2018. In addition to our proprietary products coming online, we may add licensed products which may need additional resources to manufacture. If such growth should occur for higher volume product opportunities such as Suboxone, we ~~commercialize and begin to market, following regulatory approval, our product candidates, including Libervant. Additionally, we may~~would incur increased costs associated with hiring additional personnel to support the increased manufacturing and supply costs arising from ~~our commercialization of these products~~higher manufactured volumes from proprietary and ~~product candidates. As such, we expect our manufacturing and supply costs and expenses to increase as our product candidates receive regulatory approval and production begins.~~licensed products.

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Research and Development Expenses

Since our inception, we have focused significant resources on our research and development activities. Research and development expenses primarily consist of:

employee-related expenses, including compensation, benefits, share-based compensation and travel expenses;

external research and development expenses incurred under arrangements with third ~~parties;~~

parties, such as contract research organizations, investigational sites and consultants, including costs associated with preclinical and clinical activities and regulatory operations;

the cost of acquiring, developing and manufacturing clinical study materials; and

costs associated with preclinical and clinical activities and regulatory ~~operations.~~

operations and activities.

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We expect our research and development expenses to ~~increase~~continue to be significant over the next several years as we ~~expand~~continue to seek to obtain U.S. marketing access for our ~~efforts~~Libervant product candidate and continue to develop existing product candidates such as AQST-108, AQST-305 and others, and we identify and develop or acquire additional product candidates and technologies. We may hire or engage additional skilled colleagues or third-parties to perform these activities, conduct clinical trials and ultimately seek regulatory approvals for any product candidate that successfully completes those clinical trials.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries, benefits, share-based compensation, commercialization and marketing costs, and other related costs for executive, finance, selling and operational personnel. Other significant costs include facility and related costs not otherwise included in research and development expenses such as: professional fees for patent-related and other legal expenses, consulting, tax and accounting services; insurance; selling; market research; advisory board and key opinion leaders; depreciation; ~~unabsorbed factory overhead costs~~ and general corporate expenses, inclusive of IT systems related costs.

~~Historically, our~~A significant portion of selling, general and administrative expenses ~~have been focused primarily on corporate management functions along with unabsorbed factory overhead costs. However, costs related~~relate to ~~commercialization~~the sales and marketing of our ~~CNS~~proprietary product, ~~candidates began~~at this time Sympazan, which was launched in late 2018. Sympazan is the ~~second half of 2017~~precursor and ~~significantly increased in 2018 as we progressed toward the launch of Sympazan in December 2018, and began initial preparations for~~compliment to the launch of Libervant if it is approved and granted U.S. marketing access. We believe there is a very high degree of overlap and correlation between prescribers of Sympazan and the likely prescribers of an ~~additional late-stage~~approved Libervant. While Sympazan continues to grow, we will continue to rationalize its contribution to move towards profitability while continuing to introduce epilepsy ~~product currently subject~~prescribers and patients to ~~FDA approval. These costs are expected to increase~~Aquestive and PharmFilm technology in ~~2019, with a full year effect~~advance of ~~Sympazan’s commercialization. Incremental marketing spending in preparation for~~ the anticipated launch of Libervant. The current commercial organization would begin the launch of Libervant, subject to its approval for U.S. marketing access, which cannot be assured, shortly after its approval. Until any Libervant launch is ~~expected~~certain, we do not plan to ~~be incurred prior to~~increase the ~~PDUFA date for this product~~costs of our commercial organization and will be accordingly planned once the PDUFA date is known. As part of the commercial launch of Sympazan, we entered into contractual arrangements with a third-party logistics provider (3PL) and wholesalers for distribution of our products. We also entered into a contract for our contracted sales force and medical affairs team and have established a market access account team. With this increased activity related to the commercial launch of Sympazan, our sales and marketing expenses have increased and are expectedexpect to continue to ~~increase in subsequent periods as we continue to support our epilepsy franchise. We expect to be able to significantly leverage these now existing relationships for~~improve the ~~future launch, subject to FDA approval,~~efficiency of ~~Libervant.~~ the Sympazan commercial investments.

Our general and administrative costs increased after 2017, at least partially as a result of becoming a public company, including costs related to ~~additional personnel and~~ accounting, audit, legal, regulatory and tax-related services required to maintain compliance with exchange listing and ~~other~~SEC regulations, director and officer insurance costs, and investor and public ~~company~~relations costs. ~~In addition,~~We continue to incur significant costs in ~~order~~seeking to ~~better align~~protect our ~~selling, general and administrative expenses~~intellectual property rights, including significant litigation costs in connection with ~~expected revenue, during the second quarter we reviewed and began initiatives~~seeking to ~~reduce certain expenses in non-core functions, and we~~enforce our rights concerning third parties’ at-risk launch of generic products.

We will continue to ~~review~~manage our costs to appropriately reflect the declining Suboxone revenue, the marketing and ~~assess~~sales costs related to Sympazan and other external factors affecting our ~~selling, general~~business including the continuing impact of the COVID-19 pandemic, as we continue to focus on our core business:

Seeking to obtain the approval and ~~administrative expenses relative~~subsequent launch of Libervant, subject to ~~planned revenues going forward.~~approval by the FDA for marketing in the U.S., which cannot be assured.

The continued development of AQST-108 along the 505(b)(2) pathway with PK clinical trials expected to begin in the third quarter of 2020, subject to any delays associated with the coronavirus pandemic; and

Growing the revenue contribution from Sympazan as a first step to position Aquestive in the epilepsy community.

Interest Expense

Interest expense consists of interest costs at a fixed rate of 12.5%, payable quarterly, related to our currently outstanding debt ~~facility,~~obligation at the face amount of $70,000, as well as amortization of related loan costs and the debt discount. Our ~~interest, which under our Perceptive credit facility was subject to changes~~Senior Secured Notes are discussed in ~~one-month LIBOR, represents a monthly cash payment obligation. Our new~~Note 13, 12.5% Senior Secured Notes, ~~due 2025 issued on July 15, 2019 are discussed in Note 18, Subsequent Event,~~ to our Condensed Consolidated Financial Statements and in Liquidity and Capital Resources. Interest expense ~~is expected to increase~~has increased based on additional borrowings under such ~~new~~Senior Secured Notes.

Interest Income

Interest income consists of earnings derived from an interest-bearing account. ~~We expect to continue generating interest income in 2019 from our interest-bearing cash accounts, albeit on a declining cash balance that~~There is ~~expected~~no minimum amount to be ~~applied to operating costs as needed.~~maintained in the account nor any fixed length of period for which interest is earned.

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~~Change in Fair Value of Warrant~~

Changes in the fair value of warrants resulted from non-cash periodic revaluations of the warrants issued to Perceptive Credit Opportunities Fund in connection with the debt facility. Effective with the automatic exercise of the warrants by Perceptive prior to our IPO in July 2018, these warrants are no longer outstanding and no future related charges to earnings will be incurred. Warrants issued in conjunction with the Notes issued on July 15, 2019 will be valued at market, and revaluations will impact future periods related to the new Warrants.

~~For information concerning the Warrants issued in connection with our 12.5% Senior Secured Notes due 2025, see Note 18, Subsequent Event, to our Consolidated Financial Statements.~~

Results of Operations

Comparison of the ~~Three Months~~Three-Month Periods Ended June 30, ~~2019~~2020 and ~~2018~~2019

We recorded revenue of $21,675 and $11,129 ~~and $13,928 in~~during the ~~three months~~three-month periods ended June 30, ~~2019~~2020 and ~~2018,~~2019, respectively, generating a net ~~loss~~losses of $2,334 and $20,472 ~~and $36,493~~ for ~~the three months ended June 30, 2019 and 2018, respectively.~~those three-month periods.

Revenues:

	Three Months Ended June 30,				Change					Three Months Ended June 30,				Change
(In thousands, except %)	2019		2018		$			%		2020		2019		$				%
Manufacture and supply revenue	$	8,915	$	8,684	$	231		3	%	$	7,259	$	8,915	$	(1,656	)		(19	%)
License and royalty revenue		424		4,532		(4,108	)	(91	%)		12,928		424		12,504		NM
Co-development and research fees		1,019		712		307		43	%		266		1,019		(753	)		(74	%)
Proprietary product sales, net		771		-		771		100	%		1,222		771		451			59	%
Total revenues	$	11,129	$	13,928	$	(2,799	)	(20	%)	$	21,675	$	11,129	$	10,546			95	%

For the ~~three months~~three-month period ended June 30, ~~2019,~~2020, total revenues ~~decreased 20%~~increased 95% or ~~$2,799~~$10,546 to ~~$11,129~~$21,675 compared to revenues of ~~$13,928~~$11,129 for the same period in ~~2018.~~ 2019. The change is primarily attributable to ~~differences~~increases in license and royalty revenue ~~that by nature are variable as to timing~~ and magnitude. Additionally, under the Indivior Supplemental Agreement license fees are currently suspended following the “at risk” launches of several generic buprenorphine/naloxone products into the Suboxone market. These fees are recoverable in ~~the future under certain conditions. These are~~proprietary product sales revenue, offset in part by ~~increases~~decreases in manufacture and supply revenue and co-development and research ~~fees and proprietary product sales revenue from Sympazan, launched in December 2018.~~fees.

Manufacture and supply revenue ~~increased~~decreased approximately 3%19% or ~~$231~~$1,656 to ~~$8,915~~$7,259 for the ~~three months~~three-month period ended June 30, ~~2019~~2020 compared to ~~$8,684 from~~$8,915 realized during the same period in the prior ~~year period.~~year. This ~~increase~~decrease is attributable to ~~slightly higher Suboxone product mix of higher margin dose configurations~~lower volume in 2020 partially offset ~~in part~~ by 1.8 million fewer strips sold period over period. As of the early part of third quarter 2019, Suboxone and its authorized generic maintained a greater than 75% share in the market. While it is uncertain to predict the generic erosion effect onincreased pricing associated with our Suboxone product ~~volumes in future periods,~~affecting the current period. We expect Suboxone to continue to experience market ~~for Suboxone product, including~~share erosion as generic ~~competitor products,~~competition continues to ~~grow and we will~~take more market share. We continue to ~~closely monitor these dynamics in~~plan for the ~~marketplace.~~further erosion of this sunsetting product over time.

License and royalty revenue ~~decreased 91% or $4,108~~increased $12,504 to ~~$424~~$12,928 for the ~~three months~~three-month period ended June 30, ~~2019~~2020 compared to revenues of ~~$4,532~~$424 from the prior year period. This change was primarily related to a $4,000 milestone earned upon the ~~license and new patent fees~~FDA approval on ~~our licensed~~May 21, 2020 of Sunovion’s apomorphine sublingual film product ~~Suboxone. License fees totaled $0 for the three months ended June 30, 2019 compared to $4,250 of license fees~~(KYNMOBI ™). Royalty revenue from Kynmobi aggregating $8,000 was recognized during the prior year period. Suboxone related license fees were $4,250 lower compared to 2018, as a result of the fact that certain license fees due from Indivior have been suspended pending the outcome of litigation related to infringement claims against the generic products launched “at risk.” Royalty revenues earned on Suboxone and Zuplenz were flat year-over-year on similar product sales volumes flowing through our licensees’ sales and distribution channels. License fees are generally driven by transfer of rights, patent performance contingencies, specific FDA or other regulatory achievements, sales levels achievements or other contingencies and milestones, and will likely fluctuate significantly from quarter-to-quarter.

Co-development and research fees increased 43% or $307 to $1,019 for the three months ended June 30, 2019 compared to $712 from the prior year period. The increase was driven by the timing of the achievement of research and development performance obligations on licensed products and related milestones and are normally expected to fluctuate significantly one reporting period to the next.

Product sales, net increased $771 or 100% for the three months ended June 30, 2019 compared to the prior year period, due to the launch of our first proprietary self-developed medicine, Sympazan, in December 2018.

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~~Expenses and Other:~~

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

Manufacture and supply costs and expenses increased 9% or $447 to $5,420 for the three months ended June 30, 2019 compared to $4,973 for the same period in 2018. This increase was primarily driven by lower volumes of Suboxone production and higher production costs associated with other products. Additionally, there was a $110 increase in share-based compensation costs during the three months ended June 30, 2019 as compared to the same period in 2018. These increases were offset in part by $345 in compensation cost associated with the issuance of the non-voting common shares and related withholding taxes allocated to manufacture and supply costs and expense during the three month period ended June 30, 20182020 that did not occur during the ~~three month period ended June 30, 2019.~~

Research and development expenses increased 2% or $157 to $8,151 for the three months ended June 30, 2019 compared to $7,994 in the prior year period. This increase resulted from an increase of clinical trials expenses of $1,625 along with added expenses of organizational growth that was substantially offset by a net reduction of share-based compensation expenses totaling $2,053 that was primarily attributable to the one-time settlement in 2018 of the Company’s obligations arising from its Performance Unit Plan. Clinical trial and other third party product development expenses may be expected to fluctuate based on the schedule of clinical and development activities that are conducted during any reporting period.

Selling, general and administrative expenses decreased 52% or $17,422 to $16,246 for the three months ended June 30, 2019 as compared to $33,668 for the prior year period. This decrease is primarily due to $24,767 in compensation cost associated with the issuance of the non-voting common shares and related withholding taxes allocable to selling, general and administrative expenses during the three month period ended June 30, 2018 that did not occur during the three month period ended June 30, 2019, offset in part by $3,631 of investments in our commercialization, branding and marketing capabilities for Sympazan and in preparation for the expected launch of Libervant. These costs included those for personnel, external consultants and other resources that enabled us to establish key commercial functions such as sales and marketing, market access and medical affairs. We incurred $535 of increased legal fees in connection with the ongoing state anti-trust litigation and other patent related matters, and $1,589 of share-based compensation expense. Further, additional personnel and other external resources have been engaged to further assist us in operations as a public company.

~~Interest expense increased 1% or $10 to $1,937 for the three months ended June 30, 2019 compared to 1,927 for the~~ same period in ~~2018. Our interest expense was subject to fluctuations based on one-month LIBOR. Our new Senior Secured Note due 2025 issued on July 15,~~ 2019, ~~carry a 12.5% fixed interest rate per annum.~~

Interest income increased 100% or $153 for the three months ended June 30, 2019, compared to the prior year period. This increase is a result of investing the net cash proceeds from our IPO in an interest-bearing account.

Change in the fair value of warrants decreased by $1,859 for the three months ended June 30, 2019 compared to the same period in 2018. For periods prior to our IPO, which was effective July 24, 2018, we remeasured the fair value of outstanding warrants each quarter in accordance with the AICPA Practice Aid, Valuation of Privately-Held Company Equity Securities issued as compensation. The Company had no outstanding warrants during the three months ended June 30, 2019. However, for information concerning the warrants issued in connection with our 12.5% Senior Secured Notes due 2025, issued on July 18, 2019, see Note 18, Subsequent Event, to our Consolidated Financial Statements.

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~~Comparison of the Six Months Ended June 30, 2019 and 2018~~

We recorded revenue of $23,772 and $37,339 in the six months ended June 30, 2019 and 2018, respectively, generating a net loss of $35,198 and $32,394 for the six months ended June 30, 2019 and 2018, respectively.

~~Revenues:~~

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
%)

For the six months ended June 30, 2019, total revenues decreased 36% or $13,567 to $23,772 compared to revenues of $37,339 for the same period in 2018. The change is primarily attributable to decreases in manufacture and supply revenue, license andwhile royalty ~~revenue, and in co-development and research fees, offset in part by an increase in proprietary product sales revenue for Sympazan, launched in December 2018.~~

Manufacture and supply revenue decreased approximately 23% or $4,660 to $15,584 for the six months ended June 30, 2019 compared to $20,244 from the prior year period. This decrease is attributable to lower Suboxone production volume. As of the early part of third quarter 2019, Suboxone and its authorized generic maintained a greater than 75% market share. While it is uncertain to predict the generic erosion effect on our Suboxone product volumes in future periods, the market for Suboxone product, including generic competitor products, continues to grow and we will continue to closely monitor these dynamics in the marketplace.

License and royalty revenue decreased 64% or $8,986 to $5,046 for the six months ended June 30, 2019 compared to revenues of $14,032 from the prior year period. This change was primarily related to the license and new patent fees on our licensed product Suboxone. License fees totaled $4,250 for the six months ended June 30, 2019 compared to $13,500 of license fees recognized during the prior year period. Suboxone related license fees were $9,250 lower compared to 2018, as a result of two factors: the uneven timing and magnitude of the various payments owed to the Company by Indivior and the fact that certain license fees due from Indivior have been suspended pending the outcome of litigation related to infringement claims against the generic products launched “at risk.” Milestones from other licensed products such as Sunovion’s APL-130277 product are likely to be earned after 2019 based on the timing of the expected PDUFA date for that product. Royalty revenues earned on Suboxone and Zuplenz remained relatively flat ~~year-over-year on similar product sales volumes flowing through our licensees’ sales and distribution channels.~~year-over-year. License fees are generally driven by transfer of rights, patent performance contingencies, specific FDA or other regulatory achievements, sales levels achievements or other contingencies and milestones, and will likely fluctuate significantly from quarter-to-quarter.

Co-development and research fees decreased ~~42%~~74% or ~~$1,274~~$753 to ~~$1,789~~$266 for the ~~six months~~three-month period ended June 30, ~~2019~~2020 compared to ~~$3,063~~$1,019 from the prior year period. The decrease was driven by the timing of the achievement of research and development performance obligations ~~on licensed products~~and are normally expected to fluctuate significantly from one reporting period to the next.

Proprietary product sales, net increased $451 or 59% to $1,222 for the three-month period ended June 30, 2020 compared to $771 during the prior year period due to increased Sympazan prescriptions written by CNS physicians and improved payor approval rates.

Expenses and Other:

	Three Months Ended June 30,						Change
(In thousands, except %)	2020			2019			$			%
Manufacture and supply	$	3,539		$	5,420		$	(1,881	)	(35	%)
Research and development		3,847			8,151			(4,304	)	(53	%)
Selling, general and administrative		13,894			16,246			(2,352	)	(14	%)
Interest expense		2,747			1,937			810		42	%
Interest income		(18	)		(153	)		(135	)	(88	%)

Manufacture and supply costs and expenses decreased 35% or $1,881 to $3,539 for the three-month period ended June 30, 2020 compared to $5,420 for the same period in 2019. The decrease was driven by lower volumes of Suboxone in the 2020 period compared to 2019

Research and development expenses decreased 53% or $4,304 to $3,847 for the three-month period ended June 30, 2020 compared to $8,151 recorded during the prior year period. Research and development expenses are driven primarily by the timing of clinical trial activities associated with the Company’s pipeline.

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Selling, general and administrative expenses decreased 14% or $2,352 to $13,894 for the three-month period ended June 30, 2020 as compared to $16,246 for the prior year period. The decrease was driven by careful management of expenses primarily in sales and marketing as well as factory overhead costs.

Interest expense increased 42% or $810 to $2,747 for the three-month period ended June 30, 2020 compared to $1,937 for the same period in 2019. This was the result of $20,000 of additional outstanding debt and related ~~milestones,~~higher loan acquisition and discount costs associated with the issuance of our Senior Secured Notes in July 2019. Prior to July 15, 2019, our interest expense was subject to fluctuations based on one-month LIBOR under the prior Perceptive Loan and was approximately 12% to 12.5%. Our new Senior Secured Notes due 2025 issued on July 15, 2019 carry a 12.5% fixed interest rate per annum.

Interest income decreased 88% or $135 for the three-month period ended June 30, 2020, compared to the prior year period. This decrease is a result of lower interest rates and of investing lower net cash balances during 2020 compared to the same period in 2019.

Comparison of the Six-Month Periods Ended June 30, 2020 and 2019

We recorded revenue of $30,440 and $23,772 during the six-month periods ended June 30, 2020 and 2019, respectively, generating a net loss of $18,864 and $35,198 for those periods.

Revenues:

	Six Months Ended June 30,				Change
(In thousands, except %)	2020		2019		$			%
Manufacture and supply revenue	$	14,175	$	15,584	$	(1,409	)	(9	%)
License and royalty revenue		13,354		5,046		8,308		165	%
Co-development and research fees		529		1,789		(1,260	)	(70	%)
Proprietary product sales, net		2,382		1,353		1,029		76	%
Total revenues	$	30,440	$	23,772	$	6,668		28	%

For the six-month period ended June 30, 2020, total revenues increased 28% or $6,668 to $30,440 compared to revenues of $23,772 for the same period in 2019. The change is primarily attributable to increases in license and royalty revenue and proprietary product sales revenue for Sympazan, offset in part by decreases in manufacture and supply revenue and in co-development and research fees.

Manufacture and supply revenue decreased approximately 9% or $1,409 to $14,175 for the six-month period ended June 30, 2020 compared to $15,584 recognized during the prior year period. This decrease is attributable to lower volume in 2020 partially offset by increased pricing associated with our Suboxone product affecting the current period.

License and royalty revenue increased 165% or $8,308 to $13,354 for the six-month period ended June 30, 2020 compared to revenues of $5,046 realized during the comparable prior year period. License fees were approximately even in the comparable periods. The 2020 period included a $4,000 milestone earned upon the FDA approval on May 21, 2020 of Sunovion’s KYNMOBI ™ product whereas the 2019 period included $4,250 in license and new patent fees derived from our licensed product Suboxone. All further license fees due from Indivior have been suspended pending the outcome of litigation related to infringement claims against the generic products that have launched “at risk.” In the 2020 period, royalty revenue increased significantly from $8,000 of Kynmobi royalties recognized upon the approval of Kynmobi while royalty revenues earned on Suboxone and Zuplenz slightly increased year-over-year.

Co-development and research fees decreased 70% or $1,260 to $529 for the six-month period ended June 30, 2020 compared to $1,789 during the prior year period. The decrease was driven by the timing of the achievement of research and development performance obligations, both of which are normally expected to fluctuate significantly one reporting period to the next.

~~Product~~Proprietary product sales, net increased ~~$1,353~~76% or ~~100% for~~$1,029 during the ~~six months~~six-month period ended June 30, ~~2019~~2020 to $2,382, compared to the same prior year period ~~due~~of $1,353. Acceptance within medical and patient communities has steadily continued to ~~the~~improve following Sympazan’s launch ~~of our first proprietary self-developed medicine, Sympazan,~~ in December 2018.

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Expenses and Other:

	Six Months Ended June 30,						Change							Six Months Ended June 30,					Change
(In thousands, except %)	2019			2018			$				%		2020			2019			$			%
Manufacture and supply	$	8,926		$	10,609		$	(1,683	)		(16	)%	$	7,198		$	8,926		$	(1,728	)	(19	%)
Research and development		12,454			12,895			(441	)		(3	)%		8,201			12,454			(4,253	)	(34	%)
Selling, general and administrative		34,154			41,213			(7,059	)		(17	)%		28,507			34,154			(5,643	)	(17	%)
Interest expense		3,863			3,876			(13	)		0	%		5,518			3,863			1,655		43	%
Interest income		(427	)		(22	)		405		NM				(120	)		(427	)		(307	)	(72	%)
Other		-			1,162			(1,162	)	NM

Manufacture and supply costs and expenses decreased ~~16%~~19% or ~~$1,683~~$1,728 to ~~$8,926~~$7,198 for the ~~six months~~six-month period ended June 30, ~~2019~~2020 compared to ~~$10,609~~$8,926 for the same period in ~~2018. This~~2019. The decrease was ~~primarily~~ driven by lower ~~production costs due~~volumes of Suboxone in the 2020 period compared to the lower volume of Suboxone. Further, there was a $110 increase in share-based compensation expenses offset by $345 in compensation cost associated with the issuance of the non-voting common shares and related withholding taxes allocated to manufacturing and supply costs and expenses during the six month period ended June 30, 2018 that did not occur during the six month period ended June 30, 2019.

Research and development expenses decreased 3%34% or ~~$441~~$4,253 to $8.201 for the six-month period ended June 30, 2020 compared to $12,454 for the ~~six months ended June 30, 2019 compared to $12,895 in the~~same prior year period. ~~This net expense reduction was~~Research and development expenses are driven primarily by the ~~result~~timing of ~~a net decrease of share-based compensation expenses of $1,845 due primarily to the one-time settlement in 2018 of~~clinical trial activities associated with the Company’s obligations arising from its Performance Unit Plan, partially offset by $1,404 of expenses arising primarily from organizational growth. Third party clinical expenses and other direct project development expenses remained stable during the two periods. Clinical trial and other third party direct product development expenses may be expected to fluctuate based on the schedule of clinical and development activities that are conducted during and reporting period.pipeline.

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Selling, general and administrative expenses decreased 17% or ~~$7,059~~$5,643 to $28,507 for the six-month period ended June 30, 2020 compared to $34,154 for the ~~six months ended June 30, 2019 as compared to $41,213 for the~~same prior year period. ~~This~~The decrease iswas driven by careful management of expenses primarily ~~due to $24,767~~ in compensation cost associated with the issuance of the non-voting common shares and related withholding taxes allocable to selling, general and administrative expenses offset in part by $7,692 of higher investments in our commercialization, branding and marketing capabilities for Sympazan and in preparation for the expected launch of Libervant. These costs included those for personnel, external consultants and other resources that enabled us to establish key commercial functions such as sales and marketing ~~market access and medical affairs. We incurred $1,885 of increased legal fees in connection with the ongoing state anti-trust litigation and other patent related matters, $2,377 of higher~~as well as factory ~~unabsorbed~~ overhead as a result of lower production of Suboxone period over period and $2,857 of share-based compensation expense. Further, additional personnel and other external resources have been engaged to further assist us in operations as a public company and higher factory unabsorbed overhead as a result of lower production of Suboxone period over period.costs.

Interest expense ~~remained flat~~increased 43% or $1,655 to $5,518 for the ~~six months~~six-month period ended June 30, ~~2019~~2020 compared to $3,863 for the same period in ~~2018. Our~~2019, primarily from higher debt balances starting in the third quarter 2019. Prior to July 15, 2019, our interest expense was subject to fluctuations based on one-month LIBOR. Our new Senior Secured ~~Note~~Notes due 2025 issued on July 15, 2019 carry a 12.5% fixed interest rate per ~~annum.~~annum, with an increased principal amount outstanding thereunder.

Interest income ~~increased $405~~decreased 72% or $307 for the ~~six months~~six-month period ended June 30, ~~2019~~2020, compared to the same prior year period. This decrease is a result of lower interest rates and of investing lower net cash balances during 2020 compared to the same period in ~~2018, as a result of investing the net cash proceeds from our IPO in an interest-bearing account.~~

Change in the fair value of warrants decreased by $1,162 for the six months ended June 30, 2019 compared to the same period in 2018. For periods prior to our IPO, which was effective July 24, 2018, we remeasured the fair value of outstanding warrants each quarter in accordance with the AICPA Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation. The Company had no outstanding warrants during the six months ended June 30, 2019. However, for information concerning the warrants issued in connection with our 12.5% Senior Secured Notes due 2025, issued on July 18, 2019, see Note 18, Subsequent Event, to our Consolidated Financial Statements.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception in January 2004, we have incurred significant losses and ~~expect to incur significant operating losses and negative operating cash flow for the foreseeable future and~~ as of June 30, ~~2019,~~2020, we have a net stockholders’ deficit of ~~$24,657.~~$21,388. We have funded our operations primarily with equity and debt financings, with gross margins from sales of commercialized licensed products, and ~~manufacture and supply revenue as well as~~with milestone and royalty payments from our co-development licensees.

We generate revenue from licensed products and proprietary product sales, net, certain product development and licensing agreements and related activities, but the costs to generate these revenues and the costs and expenses of our proprietary CNS and complex molecule development programs, related commercialization efforts, patent procurement, protection and prosecution initiatives and interest expenses have resulted in the $149,338 deficit we have accumulated from inception.

We had ~~$22,165~~$25,422 in cash and cash equivalents as of June 30, ~~2019 and working capital, including cash and cash equivalents,~~2020. We have no committed sources of ~~$14,435.~~capital.

~~Credit Agreement~~Equity Offering and ~~Guaranty~~Debt Refinancing

On August 16, 2016, we entered into a Credit Agreement and Guarantee with Perceptive Credit Opportunities Fund, LP, which we amended on May 21, 2018, or, as so amended, the Loan Agreement. At closing, we borrowed $45,000 under the Loan Agreement and were permitted to borrow up to an additional $5,000 within one year of the closing date based on achievement of a defined milestone. In March 2017, we met our performance obligations under the terms of the Loan Agreement and received the remaining $5,000 available to us under the Loan Agreement. The loan bore interest, payable monthly, at one-month LIBOR, which at June 30, 2019 was approximately 2.75%, plus 9.75%, subject to a minimum rate of 11.75%. The loan was interest-only through April 2019, as amended. The final payments under this agreement were due December ~~15, 2020, and repayment began on May 31, 2019. However, the agreement and related security interests were terminated with the payoff that occurred on July 15, 2019.~~

~~As of June 30,~~17, 2019, we ~~were compliant with all financial and other covenants under the Perceptive Loan Agreement.~~

~~Upon the closing~~completed an underwritten equity offering of ~~our IPO, Perceptive received 863,400~~8,050,000 shares of common stock ~~issuable~~ pursuant to ~~the automatic~~our S-3 Registration Statement, including exercise of ~~warrants for a total exercise price~~the underwriter’s over-allotment option, resulting in gross proceeds of ~~$116.~~approximately $40,250 before underwriter discounts and other costs and expenses. Net proceeds were $37,835.

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12.5% Senior Secured Notes

On July 15, 2019 we issued $70,000 aggregate principal amount of our 12.5% Senior Secured Notes due 2025 (“Senior Secured Notes”) and Warrants under ~~an Indenture.~~the Indenture for such Senior Secured Notes (“Indenture”). In addition, the Indenture provides opportunity to issue up to $30,000 of additional Notes under certain conditions for a total possible issuance amount of $100,000.

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The net proceeds from the Senior Secured Notes ~~is $66,951,~~were $66,054, after deducting ~~the estimated~~ expenses of the transaction. We used a portion of the net proceeds to repay an aggregate amount of ~~approximately~~ $52,092 of existing Perceptive indebtedness, comprised of the ~~full~~outstanding principal amount, all accrued and unpaid interest and applicable prepayment and end-of-term fees, owed to Perceptive under the Credit Agreement and Guaranty (described ~~above)~~below). We ~~will use~~used the remaining net cash ~~balance~~proceeds of approximately ~~$14,859~~$13,110 for the continued commercialization and advancement of ~~its~~our proprietary products and pipeline candidates, and other general corporate purposes.

The additional ~~notes~~Senior Secured Notes can be issued if ~~the Company satisfies~~we satisfy certain conditions and ~~achieves~~achieve certain milestones related to the filing and approval of ~~its~~our epilepsy product candidate Libervant and there are available purchasers for the additional ~~notes.~~Senior Secured Notes. Specifically, on or prior to March 31, 2021, ~~the Company has the option to~~we may issue an additional $10,000 aggregate principal amount of the Senior Secured Notes if ~~the Company has~~we filed a new drug application for ~~its~~our candidate Libervant with the FDA prior to that date, provided ~~it has~~we have obtained the written consent of the holders of a majority in aggregate principal amount of outstanding under the Notes in their discretion, which cannot be assured (first reopener), and, on or prior to March 31, 2021, up to an additional $30,000 (less the amount of any first reopener additional ~~notes~~Senior Secured Notes issued by us) if the Company obtains approval from the FDA ~~of its product candidate Libervant.~~to market Libervant in the U.S. prior to that date. There can be no assurance that such additional financing will be consummated.

Interest on the Senior Secured Notes accrues at a rate of 12.5% per annum and is payable quarterly in arrears on March 30^th, June 30^th, September 30^th and December 30^th of each year commencing on September 30, 2019. On each payment date commencing on September 30, 2021, we will also pay an installment of principal of the Senior Secured Notes pursuant to a fixed amortization schedule. The stated maturity date of the ~~Notes~~Senior Secured Note is June 30, 2025.

Collateral for the loan consists of a priority lien on substantially all assets, including intellectual property, of the Company.

Under the ~~agreement, the Company has~~Indenture, we have the right to monetize ~~its~~our royalty and milestone interests in ~~Sunovion’s Apomorphine~~our licensed product, ~~APL-130277 once the NDA for such product is approved by the FDA.~~Kynmobi. Upon any such monetization we ~~shall~~are required to offer to purchase each holder’s Notes on a pro rata basis at a repurchase price in cash equal to ~~112.500%~~112.5% of the principal amount of such Notes, plus accrued interest and unpaid interest, if any, thereon to the repurchase ~~date and such offer will be available to be exercised up to the date of the Libervant approval of the NDA by the FDA, unless exercised prior to that~~ date. The maximum amount that can be offered for repurchase is $40,000 or $50,000 if the first reopener has been issued and funded. The amount of Senior Secured Notes repurchased will be at the discretion of the holders of the Notes. See Note 13, 12.5% Senior Secured Notes, to our Condensed Consolidated Financial Statements. To the extent that the holders of the Notes do not elect repayment of the debt in connection with any such monetization, the amount not elected up to $40 million (or $50 million if the first reopener has been funded) is required to be held in a collateral account until Libervant is approved by the FDA to be marketed in the U.S.

The Indenture permits us, upon the continuing satisfaction of certain conditions, including that we (on a consolidated basis) have at least $75,000 of net revenues for the most recently completed twelve calendar month period, to enter into an asset-based borrowing facility (“~~ABL”~~ABL Facility”) ~~facility~~ not to exceed $10,000. The ABL Facility may be collateralized by assets constituting only inventory, accounts receivable and the proceeds thereof of the Company. ~~The Indenture carries customary covenants and restrictions associated with Notes of this nature.~~

Affirmative and negative covenants and restrictions specified in the Indenture are considered typical for loans of this nature, including, but not limited to, ~~specifications~~requirements relating to preservation of corporate existence, publicly traded status, intellectual property and business interests; limitations or prohibitions of dividend payments or other ~~dispositions,~~distributions, repurchases of shares, ~~additional debt, certain equity issuances,~~ asset transfers or dispositions, creation or occurrence of additional liens and security interests, and entering into licensing or monetization arrangements other than as permitted under the Indenture.

The Indenture also restricts the incurrence of additional indebtedness except only such indebtedness as is expressly permitted under the terms of the Indenture (which includes the ABL Facility) on the terms and conditions set forth in the Indenture and ~~perfection~~such indebtedness as may be permitted under limitations set forth in the Indenture. The Indenture also restricts the issuance of ~~security interests. Events of default include various commonly specified conditions,~~any “Disqualified Stock” including, ~~but not limited to, bankruptcy, insolvency, material adverse changes, failure to meet Indenture payment~~generally, mandatorily redeemable securities or ~~other obligations, compliance with regulatory requirements and preservation~~securities redeemable at the option of the ~~corporate existence and business operations~~holder or securities convertible or exchangeable at the option of the ~~Company.~~holder for indebtedness of the Company or for other Disqualified Stock.

In connection with ~~the new~~this financing, we ~~agreed to issue~~issued to the ~~new noteholders unregistered~~holders of the Notes, Warrants to purchase up to an aggregate of 2,000,000 ~~shares~~share of common stock at a price of $4.25 per Warrant. Warrants for 428,571 of common shares were exercised in December 2019 generating proceeds of $1,829. The Company registered the Warrants ~~also contain customary change~~and associated shares as part of ~~control provisions~~our S-3 Registration Statement. There were no Warrants exercised in the six-month period ended June 30, 2020.

Credit Agreement and ~~are exercisable~~Guaranty

On August 16, 2016, we entered into a Credit Agreement and Guaranty with Perceptive Credit Opportunities Fund (“Perceptive”), which we amended on ~~a “cashless” basis. The Warrants include~~May 21, 2018, or, as so amended, the Loan Agreement. At closing of the Loan Agreement, we borrowed $45,000 under the Loan Agreement and were permitted to borrow up to an ~~obligation for the Company to use reasonable best efforts to register the Warrant shares for resale with the Securities and Exchange Commission~~additional $5,000 within ~~90 days~~one year of the closing date based on achievement of a defined milestone. In March 2017, we met our performance obligations under the terms of the Loan Agreement and ~~grant customary piggy-back rights~~received the remaining $5,000 available to us under the Loan Agreement. Proceeds under the Loan Agreement were used to repay an existing debt obligation of $37,500, with the balance available for general corporate purposes. The loan from Perceptive was originally scheduled to mature on August 16, 2020.

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Upon the consummation of our IPO, the maturity date of the Loan Agreement was extended to December 16, 2020. The loan bore interest, payable monthly, at one-month LIBOR plus 9.75%, subject to a minimum rate of 11.75%. The loan was interest-only through April 2019, as amended. Also, upon the closing of the IPO, Perceptive received 863,400 shares of common stock issuable pursuant to the ~~holders~~automatic exercise of warrants for a total exercise price of $116. In July 2019, in connection with out issuance of our Senior Secured Notes (see above) we repaid all outstanding amounts due under the ~~Warrants.~~Loan Agreement with Perceptive.

Federal Paycheck Protection Loan

In April 2020, we received a $4,800 loan under the Federal Paycheck Protection Program (“PPP”) created under the CARES Act. In response to revised eligibility guidelines announced by the U.S. Small Business Administration shortly thereafter, we repaid this loan in full on May 4, 2020.

Cash Flows

~~Six Months~~Six-Month Periods Ended June 30, ~~2019~~2020 and ~~2018~~2019

(In thousands)	2019			2018
Net cash (used for) provided by operating activities	$	(34,846	)	$	1,296
(in thousands)							2020			2019
Net cash (used for) operating activities							$	(23,634	)	$	(34,846	)
Net cash (used for) investing activities		(486	)		(886	)		(243	)		(486	)
Net cash (used for) financing activities		(3,102	)		(7,151	)		(27	)		(3,102	)
Net decrease in cash and cash equivalents	$	(38,434	)	$	(6,741	)	$	(23,904	)	$	(38,434	)

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Net Cash (Used for) ~~Provided by~~ Operating Activities

Net cash used for operating activities for the six-month period ended June 30, 2020 was $23.634. The use of cash can be understood as represented by three major factors: (1) our net loss of $18,864, (2) increase in operating assets and liabilities of $11,107 partially offset by (3) non-cash operating expenses. The non-cash operating expenses of $6,337 primarily resulted from $3,625 of share-based compensation expense recorded in the six months ended June 30, 2020. Other significant components included non-cash charges of $2,712 related to depreciation and amortization of debt issuance costs.

Net cash used for operating activities for the six-month period ended June 30, 2019 was $34,846. The use of cash can be understood as represented by three ~~main~~major factors: (1) our net loss of $35,198, (2) decrease in operating assets and liabilities of $5,822 partially offset by (3) non-cash operating expenses. The non-cash operating expenses of $6,174 primarily resulted from $3,330 of share-based compensation expense recorded in the six months ended June 30, 2019. Other significant components included non-cash charges of $2,844 related to depreciation ~~amortization~~ and amortization of debt issuance costs.

~~Net cash provided~~Cash used by ~~operating activities for the six months ended June 30, 2018 was $1,296. The provision~~operations improved in 2020 compared to 2019 comparable periods due to management of cash can be understood as represented by three main factors: (1) non-cash operating expenses of $31,204, which included $27,305 related to the termination of the Company’s performance unit plans and $3,899 in non-cash charges such as depreciation, amortization, amortization of debt issuance costs and ~~changes~~expenses in ~~warrant valuation, (2) changes~~2020 to focus on key priorities outlined previously in working capital accounts totaling $2,486, primarily through collections of trade receivables and increases in trade payables as management sought to optimize our liquidity, offset in part by (3) our net loss of $32,394.the MD&A.

Net Cash (Used for) Investing Activities

Net cash used for investing activities was $243 for the six-month period ended June 30, 2020 compared to $486 for the ~~six months~~six-month period ended June 30, ~~2019 compared to $886 for the six months ended June 30, 2018.~~2019. This decrease in net cash used for investing activities was primarily attributable to timing of capital expenditures for plant and equipment purchases.

Net Cash (Used for) Financing Activities

Net cash used for financing activities was $27 for the six-month period ended June 30, 2020 compared to $3,102 for the ~~six months~~six-month period ended June 30, ~~2019 compared to $7,151~~2019. The cash used in 2020 is a result of payment for withholding taxes on share-based compensation offset, in part by proceeds received from employees participating in the ~~six months ended June 30, 2018.~~Company’s Employee Stock Purchase Plan. The cash used in 2019 is ~~primarily the~~a result of the payment of ~~$2,664 in~~ withholding taxes associated with tax reimbursement payments from the share-based compensation recorded during 2018 and a $550 loan principal ~~payment made during May 2019 related~~repayment to ~~the~~Perceptive Credit ~~Agreement and Guaranty,~~partially offset ~~in part~~ by $112 of proceeds ~~derived from common stock purchased by eligible employees through~~received under the Company’s employee stock purchase plan. Net cash used for financing activities in the prior year period was the result of $1,528 transaction costs incurred related to our IPO and $5,623 related to the payment of withholding taxes associated with the share-based compensation recorded during the quarter ended June 30, 2018.ESPP program.

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Funding Requirements

We expect that our existing cash and cash equivalents combined with our anticipated revenue from our licensed product activities, including expected milestone payments, other co-development payments and royalty payments, manufacturing and supply revenues at anticipated levels, ~~and anticipated~~ sales of our proprietary product ~~and the net proceeds from the issuance of our 12.5% Senior Secured Notes due 2025 issued~~at anticipated levels, cash on July 15, 2019 and, assuming satisfaction of all conditions and requirements for further senior secured notes issuances of additional senior secured notes, and available purchasers thereof, additional proceeds from future issuances of up to $30,000 of additional Senior Secured Notes, andhand, expense management initiatives at anticipated levels, potential future monetization of certain royalty streams or other license rights ~~such as apomorphine~~for Kynmobi (subject to all conditions and requirements under the ~~indenture)~~Senior Secured Notes Indenture and subject to acceptable market conditions, timing, structure and terms), and subject to satisfaction of all conditions to and requirements for further issuances of our Senior Secured Notes, and assuming available purchasers thereof, potential additional proceeds from future issuances of additional Senior Secured Notes, and, if needed, and available to the Company, further access to the capital markets, including under our shelf registration statement filed with the SEC and declared effective September 17, 2019, will be adequate to fund our expected cash requirements for ~~at least~~ the next 12 months, including investments in the commercialization of our late stage CNS product candidates and other expected costs and expenses, capital expenditures and investments in new product candidates in epilepsy and other CNS diseases.months. We have based this expectation on assumptions that could change, or prove to be inaccurate, and additionally, we could utilize our available financial resources sooner than we currently expect.

In addition, the global coronavirus pandemic continues to rapidly evolve. The extent to which the coronavirus pandemic may impact our business, financial results, liquidity and potential cash resources (including access to debt and equity markets including any potential monetization transaction) will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

The key assumptions underlying ~~this expectation~~our funding expectations for the next 12 months include:

~~continued revenue from our proprietary and licensed products at planned levels;~~

●

current cash balances;

~~cost and expense reductions consistent with our anticipated revenues, and continuing review of our cost structure;~~

●

continued revenue from our proprietary and licensed products at planned levels;

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);

●

our ability to monetize royalty streams related to Kynmobi at anticipated levels, which cannot be assured (and which is subject to conditions and requirements under the Indenture for our 12.5% Senior Secured Notes including note repurchase obligations at 112.5% of principal amount of such repurchased notes and accrued and unpaid interest thereon, at the option of the holders, and cash collateral account requirements (see “12.5% Senior Secured Notes” above) and to acceptable market conditions, timing, structure and terms which cannot be assured);

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);

●

access to the capital markets if and at the time needed for any necessary future funding, including any potential monetization of the Kynmobi royalties;

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~~continued funding~~

●

continuing review of our cost structure and cost and expense reductions consistent with our anticipated revenues and funding;

●

our ability to potentially issue and assuming available purchasers of, additional Senior Secured Notes in an aggregate amount up to $30,000 principal amount under the Indenture, based on satisfying certain conditions related to our Libervant product candidate and other requirements which we cannot assure (see “12.5% Senior Secured Notes” above);

●

continued funding of appropriate commercialization costs for Sympazan, our first proprietary product launched in December 2018 and continued funding of our development and, subject to FDA approval to market Libervant in the U.S., commercialization of our product candidate 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 Senior Secured Notes, and

●

absence of significant unforeseen cash requirements.

We commercially launched our first proprietary product ~~launched~~Sympazan in ~~December~~late 2018, and ~~continued funding~~this product’s net revenue continues to grow as expected. Because of the short duration of time since its initial launch, we currently spend more on commercialization costs then we receive in net revenue for Sympazan, and we expect this to be the case throughout 2020, the second full year after initial launch. Sympazan is our precursor to Libervant and enables the epilepsy and neurology community to become familiar with our Company and our PharmFilm® technology in advance of a launch of Libervant subject to approval by the FDA for U.S. marketing access, which cannot be assured. For our commercialization efforts to continue to be successful we must continue to train, deploy and further develop an effective sales and marketing organization and infrastructure. To become and remain profitable we must continue to develop, obtain timely regulatory approval of, and successfully commercialize or otherwise out-license or monetize, those of our ~~development~~proprietary products and ~~commercialization of CNS~~ product candidates that we believe will have the most market potential and commercial success. We may encounter difficulties and delays in the regulatory approval process for our drug candidates, including Libervant, and our ~~other proprietary product candidates;~~

commercialization efforts may take longer to achieve than planned. Our business or operations may change and we may also encounter unanticipated or unbudgeted events or expenses that may require cash resources more rapidly than planned. We are unable to determine or forecast with certainty when or if we will achieve or sustain profitability. The uncertainties associated with the coronavirus pandemic increase these risks.

~~the infrastructure and administrative~~Table of Contents

We expect to continue to manage business costs to appropriately reflect the declining state of Suboxone revenues, the marketing and sales costs related to Sympazan, the outcome of any Kynmobi monetization and other external factors affecting our business including the uncertainties associated with the coronavirus pandemic, as we continue to focus on the core drivers of value for our stockholders. We will continue to invest and devote financial resources to our ongoing product development activities in support ~~being a public company;~~

of Libervant and AQST-108. We expect to continue to seek to rationalize our costs as Suboxone revenue declines and to extend our capital runway. Additionally, we expect to seek to conservatively manage our pre-launch spending as to both timing and level relating to Libervant, including seeking to rationalize the costs associated with marketing and selling Sympazan. In this regard, absent spending on launch activities for Libervant we expect to spend less on commercialization in 2020 compared to 2019. Even as such, we expect to continue to incur losses and negative cash flows and therefore we expect to be dependent upon external financing and funding to achieve our operating plan.

Number		Description

~~4.1~~		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).
~~4.2~~		~~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).~~
~~10.1~~		~~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).~~
~~10.2~~		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).
31.1		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).
31.2		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).
32.1		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).
32.2		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~~ 4, 2020	/s/ Keith J. Kendall
		Keith J. Kendall
		President and Chief Executive Officer
		(Principal Executive Officer)

Date:	August ~~6, 2019~~ 4, 2020	/s/ John T. Maxwell
		John T. Maxwell
		Chief Financial Officer
		(Principal Financial Officer)

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	)

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