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, 2019March 31, 2020

OR

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

For the transition period from _____ to
For the transition period from _____  to _____

Commission File Number: 001-38599

Aquestive Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)

Delaware30 Technology Drive, Warren, NJ 0705982-3827296
(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)

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

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001 per shareAQSTNASDAQ 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, 2019May 1, 2020 was 25,026,593.33,582,696.



AQUESTIVE THERAPEUTICS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED JUNE 30,MARCH 31, 2019
TABLE OF CONTENTS

  Page No.
PART I – FINANCIAL INFORMATION
 
  
Item 1.
Financial Statements (Unaudited)
 
 21
 32
 43
 54
 65
Item 2.
2122
Item 3.
3437
Item 4.
3437
   
PART II – OTHER INFORMATION
 
  
Item 1.
3638
Item 1A.
3740
Item 2.
3741
Item 3.
3841
Item 4.
3841
Item 5.
3841
Item 6.
3842
   
3943

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
  
March 31,
2020
  
December 31,
2019
 
Assets           
Current assets:           
Cash and cash equivalents $22,165  $60,599  $35,521  $49,326 
Trade and other receivables, net  10,150   6,481  9,536  13,130 
Inventories, net  4,647   5,441  3,087  2,859 
Prepaid expenses and other current assets  2,102   1,680   2,944   2,999 
Total current assets  39,064   74,201  51,088  68,314 
Property and equipment, net  10,933   12,207  9,059  9,726 
Intangible assets, net  178   204 
Other assets  233   239 
Right-of-use assets, net 3,912   
Intangible assets, net and other assets  428   439 
Total assets $50,408  $86,851  $64,487  $78,479 
              
Liabilities and shareholders’ (deficit)/equity        
Liabilities and stockholders’ deficit      
Current liabilities:              
Accounts payable and accrued expenses $23,479  $27,631  $14,090  $17,749 
Lease liabilities, current 609   
Deferred revenue, current  600   721   663   806 
Loans payable, current  550   4,600 
Total current liabilities  24,629   32,952  15,362  18,555 
Loans payable, net  46,884   42,603  60,922  60,338 
Lease liabilities 3,424   
Deferred revenue, net of current portion  2,266     4,209  4,348 
Asset retirement obligations  1,286   1,216   1,399   1,360 
Total liabilities  75,065   76,771   85,316   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; 33,582,696 and 33,562,885 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively 34  34 
Additional paid-in capital  74,744   71,431  126,141  124,318 
Accumulated deficit  (99,426)  (61,376)  (147,004)  (130,474)
Total shareholders’ (deficit)/equity  (24,657)  10,080 
Total liabilities and shareholders’ (deficit)/equity $50,408  $86,851 
Total stockholders’ deficit  (20,829)  (6,122)
Total liabilities and stockholders’ deficit $64,487  $78,479 

See accompanying notes to the condensed consolidated financial statements.

AQUESTIVE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data amounts)
(Unaudited)

  
Three Months Ended
March 31,
 
  2020  2019 
Revenues 
$
8,765
  
$
12,643
 
Costs and expenses:        
Manufacture and supply  
3,659
   
3,506
 
Research and development  
4,354
   
4,303
 
Selling, general and administrative  
14,613
   
17,908
 
Total costs and expenses  
22,626
   
25,717
 
Loss from operations  
(13,861
)
  
(13,074
)
Other income/(expenses):        
Interest expense  
(2,771
)
  
(1,926
)
Interest income  
102
   
274
 
Net loss before income taxes  
(16,530
)
  
(14,726
)
Income taxes      
Net loss 
$
(16,530
)
 
$
(14,726
)
Comprehensive loss 
$
(16,530
)
 
$
(14,726
)
Net loss per share - basic and diluted 
$
(0.49
)
 
$
(0.59
)
Weighted-average number of common shares outstanding - basic and diluted  
33,569,694
   
24,963,603
 

See accompanying notes to the condensed consolidated financial statements.

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.

AQUESTIVE THERAPEUTICS, INC.
Condensed Consolidated Statements of Changes in Shareholders’Stockholders’ 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
)
  Common Stock  
Additional
Paid-in
  Accumulated  
Total
Stockholders'
 
  Shares  Amount  Capital  Deficit  Deficit/Equity 
                
                
Balance December 31, 2019
  
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, March 31, 2020  
33,582,696
  
$
34
  
$
126,141
  
$
(147,004
)
 
$
(20,829
)
                     
Balance December 31, 2018
  
24,957,309
  
$
25
  
$
71,431
  
$
(61,376
)
 
$
10,080
 
Adoption of ASU 2014-09 and ASU 2018-07        
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
)

* Represents balances as of December 31, 2017 as adjusted forSee accompanying notes to the reorganization from LLC to C corporation business structure effective at the close of business on that date.condensed consolidated financial statements

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
)
AQUESTIVE THERAPEUTICS, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)

  
Three Months Ended
March 31,
 
  2020  2019 
Cash flows from operating activities:      
Net loss $(16,530) $(14,726)
Adjustments to reconcile net loss to net cash used for operating activities:        
Depreciation and amortization  887   783 
Share-based compensation  1,860   1,520 
Amortization of debt issuance costs and discounts  584   389 
Non-cash interest expense  -   527 
All other non-cash expenses  (144)  (45)
Changes in operating assets and liabilities:        
Trade receivables and other receivables  3,738   (963)
Inventories, net  (228)  304 
Prepaid expenses and other current assets  53   (1,715)
Accounts payable and accrued expenses  (3,575)  (3,306)
Deferred revenue  (282)  (448)
Net cash used for operating activities  (13,637)  (17,680)
Cash flows from investing activities:        
Capital expenditures  (131)  (376)
Net cash used for investing activities  (131)  (376)
Cash flows used for financing activities:        
Payments for taxes on share-based compensation  (37)  (2,609)
Net cash used for financing activities  (37)  (2,609)
Net decrease in cash and cash equivalents  (13,805)  (20,665)
Cash and cash equivalents:        
Beginning of period  49,326   60,599 
End of period $35,521  $39,934 
         
Supplemental disclosures of cash flow information:        
Cash payments for interest $2,188  $1,009 
Net (decrease) in accrued capital expenditures  (84)  (253)
Net increase in financing costs included in accounts payable and accrued expenses  -   311 
         
Accrued withholding tax for share based compensation  (1)
  (4)

See accompanying notes to the condensed consolidated financial statements.

AQUESTIVE THERAPEUTICS, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)

  
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 

See accompanying notes to the condensed consolidated financial statements.

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 to address unmet medical needs and solvingsolve 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.challenges.  The Company has a late-stagecommercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, 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 throughboth 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 ConversionAquestive is subject to risks common to companies in similar industries and Reorganization, Stock Splitsstages of development, including, but not limited to, competition from larger companies, reliance on revenue from a limited number of products and IPOcustomers, 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 the 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 PublicEquity 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 IPOsale of 4,500,0008,050,000 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 transactionother costs of approximately $9,957. The underwriter’s over-allotment option was exercisedthis 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.

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, 20182019 included in our Annual Report on Form 10-K filed with the SEC on March 14, 201911, 2020 (the “2018“2019 Annual Report on Form 10-K”). As included herein, the condensed consolidated balance sheet at December 31, 20182019 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 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.

(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.

 (C) Recent Accounting Pronouncements

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 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 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 lease liabilities and right-of-use assets, 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 newamended the standard as amended, orin ASC 606 which 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.

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 effecton January 1, 2020 without material impact on our condensed consolidated financial position or results of the standard on its Condensed Consolidated Statement 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 our condensed consolidated financial position or results of operations.

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 our condensed consolidated financial position or results of operations.

Recent Accounting Pronouncements Not Adopted as of March 31, 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, 2020. 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 expense. 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 2018-132018-15 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.

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 20192020 and beyond include expenses related to continuing development and clinical evaluation of its products, costs of regulatory filings, patent prosecution expenses and litigation expenses, expenses related to commercialization of its products, debt service requirements, andas well as costs to comply with the requirements of being a public company. As of June 30, 2019,March 31, 2020, working capital including(current assets minus current liabilities) totaled $35,726, which included $35,521 of cash and cash equivalents, totaled $14,435.equivalents.

As of March 31, 2020, Aquestive has experienced a history of net losses and the dateCompany’s accumulated deficits totaled $147,004, which have been partially funded by profits from manufacture and supply operations, licensing revenues and certain other services, with the balance of issuancethe related funding requirements met by the Company’s equity and debt securities offerings and 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, $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.

In addition to the characteristics described above, the nature of which provide indications that the Company’s ability to execute its near-term business objectives and achieve profitability over the longer term cannot be assured, management views the impact of COVID-19 on the economy, its industry and its own operations as rapidly evolving, the future effects of which are highly uncertain and currently unpredictable. Due to current or future interruptions and possible disruptions in health services, FDA operations, freight and other transportation services, supply, manufacturing, workforce health, availability of favorable financial markets and other essential human and business requirements, the possibility exists that the severity, rapidity of the spread, and the duration of the COVID-19 pandemic may be expected to negatively affect such areas as pre-clinical and clinical trials of our product candidates, regulatory review and approval of our product candidates, customer demand for our products and services, our customers’ ability to pay for goods and services, uninterrupted supply of pharmaceutical ingredients and other raw materials from our approved vendors, ongoing availability of an appropriate labor force and skilled professionals, and additional capital from debt or equity investors.

Subject to and absent any material adverse effect of these unaudited interim condensed financial statements,and other possible COVID-19 effects, the Company expectsexpects 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 and the net proceedsfunds received from the issuance on July 15, 2019equity offering,potential monetization of its 12.5% Senior Secured Notes due 2025, including possible future issuancesout-licensed apomorphine product candidate, subject to regulatory approval which cannot be assured, and access to the capital markets under the Indenture (see Note 18, Subsequent Event), willits shelf registration statement, would be adequate to fund itsmeet expected cash requirementsoperating, investing, and financing needs for at least the next twelve months.

To the extent additional funds are necessary to meet liquidity or other cash needs as the Company continues to execute its business strategy, the Company will seek to satisfy suchanticipates that additional funding requirements will be obtained through monetization of certain royalty streams or through availability of additional debt or equity financings, monetization of  royalty streams, the completion of a licensing transaction for one or more of the Company’s pipeline assets,and continuing expense reduction initiatives, or a combination of these potential sources of funds. Althoughfunds, although the Company has been successful in raising capital in the past, there iscan provide no assurance that these sources of funding will be sufficient or available or on reasonable terms, if at all which, and we could adversely affect its business prospects.be required to utilize available financial resources sooner than expected.  We have based this expectation on assumptions that could 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’sOur revenues to date have been earned from partnered commercialized products, researchour product development pipeline, marketed product activities and development services provided to customers, licensing of patent-protected intellectual property and commercialization of a proprietary product.self-developed medicines. 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.

Performance Obligations

A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit 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 goods 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 in the contract regardless of whether explicitly stated in the customer contract or implied by customary business practices. The Company’s performance obligations consist mainly of transferring control of goods and services identified in the contracts, purchase orders or invoices.

The Company’s performance obligation with respect to its proprietary product sales is satisfied at a point in time which transfers control upon delivery of the product to its customers. The Company considers control to have transferred upon delivery because the customer has legal title to the asset, physical possession of the asset has been transferred, the customer has significant risks and rewards of ownership of the asset and the Company has a present right to payment at 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. Under the customer arrangements, the Company is entitled to receive payments for progress made to date once the acceptance requirements surrounding quality control are satisfied.  Thus, revenues related to this product stream isare recognized at athe point in time when the manufactured product passes quality control testing.control.

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,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 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.

Revenues from 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 days depending on the customer. The Company performs a review of each specific customer’s credit worthinesscreditworthiness 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 billingus to occurbill in arrears; accordingly,thus, we satisfy some, portions, or all, of the Company’sour performance obligations are completed before we are contractually entitled to bill the customer. In these situations, billing occurs subsequent to revenue recognition, which results in a contract asset. TheseWe reflect these contract assets are reflected as a component of other receivables within Trade and other receivables on the Condensed Consolidated Balance Sheet. As of June 30, 2019March 31, 2020, and January 1,December 31, 2019, such contract assets were $295,$1,458, and $284,$4,363, respectively.

Contract Liabilities

In other limited situations, certain customer contractual payment terms allow advanced billings; accordingly,us to bill in advance; thus, we receive customer cash payments may be receivedpayment before satisfaction ofsatisfying some or all contractualof our performance obligations. In these situations, billing occurs in advance of revenue recognition, which results in contract liabilities. TheseWe reflect these contract liabilities are reflected as Deferreddeferred revenue in theon our Consolidated Balance Sheet. As we satisfy our remaining performance obligations, are satisfied,we release a portion of the deferred revenue balance is recognized in the Company’s results of operations.balance. As of June 30, 2019March 31, 2020, and January 1,December 31, 2019, such contract liabilities were $2,866$4,872 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.

The Company’s revenues were comprised of the following:

 
Three Months Ended
June 30,
  
Six Months Ended
June 30,
  
Three Months Ended
March 31,
 
 2019  2018  2019  2018  2020  2019 
Manufacture and supply revenue 
$
8,915
  
$
8,684
  
$
15,584
  
$
20,244
  
$
6,916
  
$
6,669
 
License and royalty revenue 
424
  
4,532
  
5,046
  
14,032
  
426
  
4,622
 
Co-development and research fees 
1,019
  
712
  
1,789
  
3,063
  
263
  
770
 
Proprietary product sales, net  
771
   
-
   
1,353
   
-
   
1,160
   
582
 
Total revenues 
$
11,129
  
$
13,928
  
$
23,772
  
$
37,339
  
$
8,765
  
$
12,643
 

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
March 31,
 
2019 2018 2019 2018  2020  2019 
United States 
$
10,267
  
$
13,380
  
$
22,661
  
$
36,577
  
$
7,506
  
$
12,394
 
Ex-United States  
862
   
548
   
1,111
   
762
   
1,259
   
249
 
Total revenues 
$
11,129
  
$
13,928
  
$
23,772
  
$
37,339
  
$
8,765
  
$
12,643
 

Non-United States revenues is 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
  March 31,  December 31, 
       2020  2019 
Trade receivables 
$
10,036
  
$
6,610
  
$
8,470
  
$
9,094
 
Contract and other receivables 
290
  
33
  
1,406
  
4,363
 
Less: allowance for bad debts 
(88
)
 
(58
)
Less: allowance for bad debt
 
(84
)
 
(124
)
Less: sales-related allowances  
(88
)
  
(104
)
  
(256
)
  
(203
)
Trade and other receivables, net 
$
10,150
  
$
6,481
  
$
9,536
  
$
13,130
 

Contract and other receivables totaled $290 as of June 30, 2019, consisting primarily of contract assets related to the adoption of ASC 606 and certain reimbursable customer costs.  Other receivables totaled $33$1,406 and $4,363 as of March 31, 2020 and December 31, 2018,2019, respectively, consisting primarily of 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. 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..

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

  
June 30,
2019
  
December 31,
2018
 
       
Allowance for doubtful accounts at beginning of year 
$
58
  
$
55
 
Additions charged to bad debt expense  
30
   
53
 
Write-downs charged against the allowance  
-
   
(50
)
Allowance for doubtful accounts at end of the period 
$
88
  
$
58
 
  March 31,  December 31, 
  2020  2019 
Allowance for doubtful accounts at beginning of period
 
$
124
  
$
58
 
(Reversals)/additions charged to bad debt expense
  
(40
)
  
66
 
Recoveries from amounts previously reserved
  
--
    
Allowance for doubtful accounts at end of period
 
$
84
  
$
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.

The following table provides a summary of activity with respect to our sales related allowances and accruals for the sixthree months ended June 30, 2019:March 31, 2020:

  
Total Sales Related
Allowances and Accruals
 
    
Balance at December 31, 2018 
$
585
 
Provision  847
 
Payments / credits
  
(535
)
Balance at June 30, 2019 
$
897
 
  
Total Sales Related
Allowances and Accruals
 
Balance at December 31, 2019 
$
1,377
 
Provision related to sales during the period
  
1,157
 
Credits and payments
  
(867
)
Balance at March 31, 2020 
$
1,667
 

Total reductions of gross product sales from sales-relatedsale-related allowances and accruals were $847$1,157 for the sixthree months ended June 30, 2019.March 31, 2020.  Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction to trade receivables,receivable and totaled $88 and $104 at June 30, 2019 and December 31, 2018, respectively. Accrualsaccruals 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 $809other receivables, net and $481Accounts payable and accrued expenses were $256 and $1,411, respectively, at June 30, 2019March 31, 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 sixthree months ended June 30, 2019,March 31, 2020, revenues provided by Indivior represented approximately 86%79% of total revenues,revenue, and outstanding accounts receivable due from Indivior represented approximately 74%63% of gross receivables.

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,amendment 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 maximumminimum 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 our 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 thaneach 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, or 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”) 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.

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 arethe 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 arewere 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.

In April 2016, we entered into a license agreement with Cynapsus Therapeutics Inc. (which was later succeeded to in interest by Sunovion)Sunovion Pharmaceuticals, Inc., or “Sunovion”) referred to as the Sunovion License Agreement, pursuant to which we granted Sunovion 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) for the treatment of off episodes in Parkinson’s disease patients, as well as two other fields. Our licensee, Sunovion, as sponsor of APL-130277, submitted an NDAa New Drug Application (“NDA”) to the FDA on March 29, 2018. According to public statements by Sunovion, following the January 2019 PDUFA date, Sunovion received a Complete Response Letter from the FDA which requires additional data, but does not require additional clinical studies.  In the 2019 fourth quarter, Sunovion announced that it had received from the FDA a Prescription Drug User Fee Act (PDUFA) date of May 21, 2020 after the submission of its NDA.

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 havethe Company also earned an aggregate of $13,000 in connection with specified regulatory and development milestones in the United States and Europe (the “Initial Milestone Payments”), all of which haveof which has been received to date. No payments were received during the threethree-month period ended March 31, 2020 and six months ended June 30, 2019. We are2019, respectively. 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, and ongoing mid-single digit percentage royalty payments related to the net sales of APL-130277, (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, there can be no guarantee that any such milestones will in fact be met or that additional milestone payments will be payable.

Effective March 16, 2020, the Company entered into a first amendment (the “Amendment”) to the License Agreement (the “Agreement”) dated as of April 1, 2016.  The Amendment was entered into for the primary purpose of amending the 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 Agreement, (ii) extending the date after which Sunovion has the right to terminate the Agreement for convenience from December 31, 2024 to May 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 Agreement in the event that the licensed product 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, theThe 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’sSunovion'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 inby the Company and KemPharm during April 2011. Under this termination arrangement, we havethe Company has the right to participate in any and all value that KemPharm may derive from the commercialization or any other monetization of KP 415KemPharm’s KP-415 and KP 484KP-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. TheDuring September 2019, the Company has not received $1,000 from its 10% share of milestone payments paid to KemPharm under this arrangement during anyits licensing of the periods presented herein,KP-415 and thereKP-484 to a third party.  There can be no guarantee that any such payments will be made in the future.
  The Company has not received payments under this arrangement during the three-month periods ended at March 31, 2020 and 2019, respectively.

Note 7.
12

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 ofValuation techniques used to measure fair value must maximize the use of observable inputs and minimization ofminimize the use of unobservable inputs when estimatinginputs.  Financial assets and liabilities carried at fair value. Thevalue 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– Quoted prices in active markets for identical assets or liabilities.
  Cash and cash equivalents consisted of cash in bank checking accounts and money market funds which are all Level 1 assets.

Level 2 Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are based onnot active for identical or similar assets or liabilities, or other inputs not quoted on active markets butthat are observable or can be corroborated by observable market data.
  The Company currently has no Level 2 assets or liabilities.

Level 3 Unobservable inputs that are supported by little or no market activity such asand that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
  As of March 31, 2020 and 2019, respectively, the Company has no Level 3 assets or liabilities.

The Company’s Level 1carrying amounts reported in the balance sheets for trade and other receivables, prepaid and other current assets, foraccounts payable and accrued expenses, and deferred revenue approximate fair value based on the periods presented included cashshort-term maturity of these assets and cash equivalents, including money market funds. liabilities.

The Company held no Level 2 or Level 3 assets or liabilities asgranted warrants to certain holders of either balance sheet date presented herein. Prior to exerciseits Notes in connection with the July 2018 IPO, outstandingits debt refinancing during 2019.  These warrants held by Perceptive Credit Opportunities Fund were categorized asvalued based on Level 3 liabilities. This warrant liability was estimated atinputs and their fair value was based primarily on an independent third-party appraisalsappraisal 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’sthese 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.
Note 8.
Note 8.  Inventories, Net

The components of Inventory, net is as follows:

 
June 30,
2019
  
December 31,
2018
  March 31,  December 31, 
       2020  2019 
Raw material
 
$
1,247
  
$
1,283
  
$
1,285
  
$
1,244
 
Packaging material
 
2,366
  
2,975
  
1,101
  
1,096
 
Finished goods
  
1,034
   
1,183
   
701
   
519
 
Total inventory, net
 
$
4,647
  
$
5,441
 
Total inventories, net
 
$
3,087
  
$
2,859
 

Note 9.Property and Equipment, Net
Note 9.  Property and Equipment, Net


 
Useful
Lives
 
June 30,
2019
  
December 31,
2018
    March 31,  December 31, 
        Useful Lives 2020  2019 
Machinery
 3-15 yrs 
$
20,905
  
$
20,681
 3-15 yrs 
$
21,088
  
$
21,088
 
Furniture and fixtures
 3-15 yrs 
1,150
  
1,150
 3-15 yrs 
1,203
  
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 
2,790
  
2,787
 
Construction in progress
    
1,526
   
1,655
    
1,403
   
1,412
 
   
47,571
  
47,398
    
47,817
   
47,770
 
Less: accumulated depreciation and amortization
    
(36,638
)
  
(35,191
)
   
(38,758
)
  
(38,044
)
Total property and equipment, net
   
$
10,933
  
$
12,207
   
$
9,059
  
$
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$714 and $765$736 for the three-month periods ended June 30,at March 31, 2020 and 2019, and 2018, respectively. For the respective six-month periods, these expenses totaled $1,447 and 1,705.

Note 10.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 3.0 years and 6.5 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. For the three months ended March 31, 2020, total operating lease expenses under these leases was $442, including variable lease expenses such as common area maintenance and operating costs totaling $106.

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

Remainder of 2020 $910 
2021  1,287 
2022  1,295 
2023  944 
2024  565 
2025  565 
2026  424 
Total lease payments  5,990 
Less: imputed interest  (1,957)
Total operating lease liabilities $4,033 

Note 11.  Intangible Assets, Net and Other Assets

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

 
June 30,
2019
  
December 31,
2018
  March 31,  December 31, 
       2020  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
)
 
(2,727
)
 
(2,714
)
Total intangible assets, net
 
$
178
  
$
204
 
Intangible assets, net
  
140
   
153
 
Other assets, primarily security deposits
  
288
   
286
 
Total Intangible assets, net and other assets
 
$
428
  
$
439
 

Amortization expense was $13 and $12 for each of the three-month periods ended June 30,March 31, 2020 and 2019, and 2018, respectively. For the corresponding six-month periods, these expenses totaled $26 and $25, respectively. During the remaining life of the purchased patent, estimated annual amortization expense is $50 for each of the years from 20192020 to 2022.

Note 11.
Note 12.  Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following:

 
June 30,
2019
  
December 31,
2018
  March 31,  December 31, 
       2020  2019 
Accounts payable
 
$
20,034
  
$
20,436
  
$
10,283
  
$
12,274
 
Accrued compensation
 
2,282
  
3,604
  
1,929
  
3,758
 
Accrued withholding tax for share-based compensation
 
-
  
2,515
 
Real estate and personal property taxes
 
176
  
388
  
370
  
300
 
Accrued distribution expenses
 
809
  
481
  
1,411
  
1,174
 
Other
  
178
   
207
   
97
   
243
 
Total accounts payable and accrued expenses
 
$
23,479
  
$
27,631
  
$
14,090
  
$
17,749
 

Note 12.Note 13.  12.5% Senior Secured Notes and Loans Payable

12.5% Senior Secured Notes

On August 16, 2016,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 Loanpurchase agreement and related agreements including a Collateral Agreement with U.S. Bank National Association, as trustee and Guarantycollateral 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 “Loan Agreement”“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 our drug candidate pipeline.  Provided that no events of default exist, the Company may elect to, and subject to approval of the holder of a majority of the outstanding principal amount of the Notes, in its discretion, to 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.

Proceeds from issuance of the Initial Notes and 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 yearloan.

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 2017Initial Notes due on September 30, 2021, and the balancefinal 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. Theface amount of debt then outstanding during the first four quarters to 40% of the initial loan proceeds were used to payprincipal 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 agreedNotes at any time at premiums that range from 101.56% of outstanding principal if prepayment occurs on or after the 5th anniversary of the issue date of the Notes to make certain amendments to112.5% 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 couldmake-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 consummatedrequired 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 agreedprovides 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%, subjectsenior secured Noteholders. The Company’s license of its IP to a minimum ratethird-party drug development enterprise (specifically, Sunovion’s APL-130277 product) is one of 11.75%. Accordingly, commencing on May 31, 2019, seven monthly loanthe 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 inamount 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 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 inLibervant 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 liensbe released to the extentCompany.  Proceeds in excess 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 on$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 musttranche is issued) can be maintained at all times and (2) a minimum revenue requirement under which minimum revenuesused immediately for the trailing twelve consecutive months, measured at the end of each calendar quarter.general corporate purposes. As of June 30, 2019,March 31, 2020, the Company was in compliance with all financial 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).covenants.

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,leaders, and offsets those as a direct reduction of its outstanding debt.  Amortization expenseexpenses arising from deferred debt issuance costs and debt discounts related to the  Notes were $584 for the six-month periodsthree months ended June 30, 2019March 31, 2020, while comparative amortization expenses derived from deferred debt issuance costs and 2018 were $781 and $923, respectively;debt discounts related to the Perceptive Loan for the corresponding three-month periods these expenses totaled $392 and $465.

three months ended March 31, 2019 were $389.  Unamortized deferred debt issuance costs and deferred debt discounts totaled $2,016total $9,078 and $9,662 as of June 30,March 31, 2020 and December 31, 2019, respectively.

Loans Payable - Perceptive

In August 2016, the Company entered into a Loan Agreement and $2,797Guaranty with Perceptive Credit Opportunities Fund, LP (“Perceptive”) under which the total available facility of $50,000 had been borrowed as of December 31, 2018.

Note 13.Warrants

TheMarch 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 stockunits 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 issuanceAquestive’s IPO.  In May 2018, the Company and Perceptive agreed to make certain amendments to the loan agreement then in effect that provided for: (1) the postponement of $5,800the initial loan principal payment to May 2019, (2) a delay of the loan maturity date to December 16, 2020 and (3) with Perceptive’s consent, an agreement to permit monetization of the royalties and fees that may be derived from sales of certain apomorphine products and a concurrent agreement for the release of the liens related to these royalties and fees.

In July 2019, the Perceptive Loan was classified aspaid in full in connection with the completion of the sale of the 12.5% Notes and Warrants described above.  The early extinguishment of this debt resulted in a liability, rather than as a componentcharge to third quarter 2019 earnings of equity,an amount of $4,896, including an early retirement premium of $2,944 and wasthe 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 12.5% Senior Secured Notes (the “Notes”) 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 loanNotes 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 pricingCertain holders of the Company’s IPO, Perceptive received 863,400Notes exercised Warrants for the purchase of 428,571 shares of common stock, issuable pursuant toand proceeds totaling $1,821 were received on December 16, 2019. There were no Warrants exercised by the automatic exerciseholders of warrants at a total price of $116.  As a result, the warrant liability of $12,951 was reclassified to Additional paid-in capitalNotes during the third quarter of 2018.  A Level 1 market price of $15.00, the initial pricethree-month period ended at which the Company’s common stock was publicly offered, was used in determining fair value as of the warrants’ conversion date.March 31, 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%.

Note 14.
Note 15.  Net Loss Per Share

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

As a result of the Company’s net losses incurred for the three and six-monththree-month periods ended June 30,at March 31, 2020 and 2019, and June 30, 2018, respectively, all potentially dilutive instruments outstanding would have anti-dilutive effects on per-share calculations for these periods.this period.  Therefore, basic and diluted net loss per share were the same, as reflected below.

 
Three Months Ended
June 30,
  
Six Months Ended
June 30,
  
Three Months Ended
at March 31,
 
 2019  2018  2019  2018  2020  2019 
Numerator:                  
Net loss 
$
(20,472
)
 
$
(36,493
)
 
$
(35,198
)
 
$
(32,394
)
 
$
(16,530
)
 
$
(14,726
)
Denominator:                  
Weighted-average number of common shares – basic 
24,980,861
  
19,188,624
  
24,972,280
  
17,144,492
 
Loss per common share - basic 
$
(0.82
)
 
$
(1.90
)
 
$
(1.41
)
 
$
(1.89
)
Weighted-average number of common shares – basic and diluted  
33,569,694
  
24,963,603
 
Net loss per common share – basic and diluted 
$
(0.49
)
 
$
(0.59
)

As of June 30,March 31, 2020 and 2019, respectively, the Company’s potentially dilutive instruments included 1,983,1422,947,192, and 1,732,426 options to purchase common shares and 142,85244,036 and 172,655 unvested restricted stock units (“RSUs”)RSUs that were excluded from the computation of diluted weighted average shares outstanding because these securities had an anti-dilutive impact due to the losslosses reported.  Similarly excluded as of March 31, 2020 were potentially dilutive warrants for the purchase of 1,571,429 common shares.  No such equity securitiesdilutive warrants were issued as of June 30, 2018.March 31, 2019.

Note 15.
Note 16.  Share-Based Compensation

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

 
Three Months Ended
June 30,
  
Six Months Ended
June 30,
  
Three Months Ended
March 31,
 
Expense classification:
 2019  2018  2019  2018  2020  2019 
Manufacture and supply
 
$
72
  
$
345
  
$
116
  
$
345
  
$
63
  
$
44
 
Research and development
 
140
  
2,186
  
348
  
2,186
  
182
  
208
 
Selling, general and administrative
  
1,598
   
24,774
   
2,866
   
24,774
   
1,615
   
1,268
 
Total share-based compensation expenses
 
$
1,810
  
$
27,305
  
$
3,330
  
$
27,305
  
$
1,860  
$
1,520
 
                  
Share-based compensation from:
                  
Restricted stock units
 
$
467
  
$
  
$
930
  
$
  
$
464
  
$
463
 
Stock options
 
1,323
  
7
  
2,380
  
7
  
1,396
  
1,057
 
Non-voting common shares
 
  
27,298
  
  
27,298
 
Employee stock purchase plan
  
20
   
   
20
   
   
   
 
Total share-based compensation expenses
 
$
1,810
  
$
27,305
  
$
3,330
  
$
27,305
  
$
1,860
  
$
1,520
 

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.

Share-Based Compensation Equity Awards

The following tables providesprovide information about the Company’s restricted stock units and stock option unit activity during the sixthree months ended June 30, 2019:March 31, 2020:

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

  
Number
of Units
  
Weighted Average
Grant Date Fair
Value Per Share
 
  (In thousands)    
Unvested at December 31, 2019
  
74
  
$
14.64 
Granted
  
   
 
Vested
  
(30
)
  
15.03
 
Forfeited
  
   
 
Unvested at March 31, 2020
  
44
  
$
14.38 
Grant date fair value of shares vested during the period
 
$
448
     
Unrecognized compensation costs at March 31, 2020
 
$
435     

Unrecognized compensation costs related to awards of RSUs are expected to be recognized over a weighted-average period of less than threetwo 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
  
716
  
$
1.60
 
Exercised, Forfeited, Expired
  
     
Outstanding at March 31, 2020
  
2,947
  
$
8.27
 
Vested or expected to vest at March 31, 2020
  
2,739
  
$
8.28
 
Exercisable at March 31, 2020
  666  
$
12.75
 

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

Expected dividend yield
0
%
Expected volatility
85 - 95
%
Expected term (years)
5.5 - 6.1
Risk-free interest rate
1.9 - 2.6
%

The weighted average grant date fair value of stock options granted during 20192020 was $7.51. $1.26. The fair value of stock options granted were estimated using the Black-Scholes-Merton pricing model based upon the following assumptions:

Three Months Ended
March 31, 2020
Expected dividend yield
None
Expected volatility
100%

Expected term (years)
6.1
Risk-free interest rate
0.6% - 1.7%


During the sixthree months ended June 30, 2019,March 31, 2020, options were granted with exercise prices ranging from $4.38$1.54 to $8.05,$4.17, and accordingly, given Aquestive’s share price of $4.20$2.19 at the close of the Company’s secondfirst quarter of 2019, these options2020, certain shares granted in 2020 provided no intrinsic value of $456 at that date. Similarly, options granted in 2018 provided no intrinsic value at June 30, 2019.March 31, 2020.

As of June 30, 2019, $11,352March 31, 2020, $8,693 of total unrecognized compensation expenses related to non-vested stock options is expected to be recognized over a weighted average period of 2.32.1 years from the date of grant.

Employee stock purchase plan

The Company’s Board of Directors adopted the Aquestive Therapeutics, Inc. Employee Stock Purchase Plan or ESPP(“ESPP”) in June 2018, as amended and restated effective as of January 1, 2019. The Employee Stock Plan, features two six-month offering periods per year, running from January 1 to June 30 and July 1 to December 31. UnderRollout of the ESPP employeesbegan in late 2018, and initial employee purchases are expected to be made in 2019. The Company may elect tooffer common stock purchase rights biannually under offerings that allow for the Company’spurchase of 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 ended June 30, 2019, 31,393 shares were purchased at a total discount of $20 and were issuedNo purchases under the ESPP effective as of that date.occurred in the three months ended March 31, 2020 and 2019, respectively.

Note 16.Note 17.  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, there is no impact.

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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,March 31, 2020 and 2019, and 2018, the Company recorded no income tax benefit from its pretax losses of $20,472$16,530 and $36,493, respectively, and similarly for the sixth months ended June 30, 2019 and 2018, the Company recorded no tax benefit from its pretax loss of $35,198 and $32,394,$14,726, 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 and six months ended June 30, 2019March 31, 2020 is the anticipated full year operating loss which will require full valuation allowances against any associated net deferred tax assets.

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Note 17.Commitments andNote 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 legal proceedings that is believed to be material.

Patent-Related Litigation

Beginning in August 2013, we were informed of ANDAabbreviated 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 CompanyWe 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 Third Circuit (“Federal CircuitCircuit”) 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.

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 caseA 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 schedulednew 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 we and Indivior preserved our 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 us and Indivior.  We 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, we 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.  No trial date has been set in those cases.  We are not able to determine or predict the cases against DRL and Alvogen, which are pendingultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates, of the possible outcomes 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’sCourt’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 DRLDr. 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 DRLDr. Reddy’s and Alvogen are “at risk” because the products are the subject of the ongoing patent infringement litigations.

1819

On March 22, 2019, Aquestivewe 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 andCourt 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 isWe are also seeking to enforce itsour patent rights in multiple cases against BioDelivery Sciences International, Inc. (“BDSI”). TwoThree 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.

The second was filed by us and Indivior related to BDSI’s infringing Bunavail product, and alleges infringement of the Company’sour 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, Aquestivewe and Indivior submitted a notice to the Court on February 15, 2019 notifying the Court that the stay should be lifted as a result of the PTAB’s decisions. We are awaiting further action from the Court.

On January 13, 2017, the Companywe 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 FebruaryOn August 7, 2019, decisions on remand denying institution, the Company submitted a noticeEastern District of North Carolina Court granted BDSI’s motion to dismiss the Court on February 15, 2019 notifying the Court thatComplaint without prejudice and denied BDSI’s motion to stay should be denied as moot.  On November 11, 2019, we filed a new Complaint against BDSI also sentin the Eastern District of North Carolina Court.  On November 27, 2019, BDSI filed a lettermotion to stay the Court on February 13, 2019 indicating its intent tocase pending BDSI’s appeal of the PTAB’s decisions.remand decisions, and we opposed the motion. The parties are awaiting further action from the Court.  BDSI appealedEastern 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 FederalUnited States Court of Appeals for the Fourth Circuit (the “Federal Fourth Circuit Court”) was docketed on March 13, 2019, and on March 20, 2019, we moved to dismiss the appeal for lack of jurisdiction.
  On August 29, 2019, the Federal Fourth Circuit Court granted the motion to dismiss BDSI’s appeal.  On September 30, 2019, BDSI filed a petition for rehearing in the Federal Fourth Circuit Court en banc, which we opposed.  The Federal Fourth Circuit Court denied BDSI’s petition for rehearing en banc on January 13, 2020. After the Federal Fourth Circuit Court 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 we opposed on February 2, 2020.  The Eastern District of North Carolina Court denied BDSI’s motion to dismiss 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.  Our response to BDSI’s counterclaims is due May 7, 2020.

Antitrust Litigation

On September 22, 2016, forty-one states and the District of Columbia, or the States, brought suit against Indivior and us 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 waswe were not named as a defendant in the original Suboxone MDL cases, the action brought by the States alleges that the Companywe 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 CompanyWe moved to dismiss the States’ conspiracy claims, but by order dated October 30, 2017, the Court denied thisour motion to dismiss. AnWe filed an answer 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 beingwere conducted through August 1, 2019.  Summary judgement motions and Daubertmotions 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 witnesseswhich we are due on September 26, 2019.  At this time, management cannotnot a party. We are 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.

20

California Complaint

On December 5, 2019, Neurelis Inc. (“Neurelis”) filed a complaint against Aquestive in the Superior Court of California, County of San Diego alleging Unfair Competition, Defamation, and Malicious Prosecution related to the Company’s pursuit of FDA approval for Libervant™. Neurelis filed a First Amended Complaint on December 9, 2019, alleging the same three causes of action.  The Company filed a 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 motion for leave to file a Supplemental Complaint on February 5, 2020, which we will oppose.  A hearing on our anti-SLAPP motion and Neurelis’s motion for leave was scheduled for April 24, 2020 but was postponed as a result of court closures in San Diego County, California resulting from the COVID-19 pandemic.  The parties are awaiting further action from the court regarding a new hearing date.  We are 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.
Note 19. Subsequent Event

Debt Refinancing & Warrant IssuanceFederal Paycheck Protection Loan

On July 15, 2019, Aquestive Therapeutics, Inc. completedApril 17, 2020, the private placement of upCompany was awarded a loan under the federal Paycheck Protection Program (“PPP”) created under the CARES Act in response 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 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.the global COVID-19 pandemic.  The Company simultaneously entered into related agreements includingreceived a Collateral Agreement with$4.8 million loan (the “PPP Loan”) which carried a 1% interest rate payable in 2.5 years.  On April 23, 2020, the U.S. Bank National AssociationSmall Business Administration issued revised guidelines which we view as trusteeestablishing a strong presumption that publicly traded companies are not eligible to receive funding under the PPP.  Despite qualifying under the PPP program rules and collateral agent,having been granted the loan, given the revised guidance and a Lien Subordination and Intercreditor Agreementthe implications of possibly not meeting changing criteria 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”) 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 ofqualification, we returned 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 in a $10,000 additional offering of 12.5% senior secured notes (the “First Additional Offering”) under terms similar to the Initial Notes,PPP Loan 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 financing will be consummated.May 4, 2020.

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Proceeds from issuance 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 on or after the 5th 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, 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.

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, 2019 and 2018, and 2017respectively, included in our 20182019 Annual Report on Form 10-K. All dollar amounts are in thousands except for share data.

Forward-Looking Statements

This Quarterly Report on Form 10-Q and certain other communications made by us includesinclude 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 approvalsapproval and pathways, clinical trial timing and plans, the achievementour 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 termlong-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 also are subject to the uncertain impact of the COVID-19 global pandemic on our clinical trials including site initiation, patient enrollment and timing and adequacy of clinical trials, on regulatory submission and regulatory reviews and approvals of our product candidates; pharmaceutical ingredient and other raw materials; on supply chain, manufacture and distribution and sale of and demand of our products and 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.

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, costcosts and success of our product development activities and clinical trials; the riskstrials 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 risksFDA “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 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 of our 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); risk of development of our sales and marketing capabilities; risk of legal costs associated with and the outcome of our patent litigation challenging third partythird-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 termlonger-term cash requirements and other cash needs, at the timestime 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; risk relateddefault; risk-related to government claims against Indivior for which we license, manufacture and sell SuboxoneSuboxone® 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 impacted 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 productsproduct 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; riskrisks 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 actionactions affecting pharmaceutical product pricing, reimbursement or access; claims and concernsrisks 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 governmentalgovernment 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’sour Annual Report on Form 10‑K10-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 thesethose uncertainties, you should not place undue reliance on these forward-looking statements, which address mattersspeak 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 reportQuarterly 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 withwhich leverage our proprietary PharmFilm® technology to meetsolve patients’ unmet needs and solve therapeutic problems and to addressmeet patients’ unmet medical needs. We have three commercial products, on the market, including one that is proprietary product and two out-licensed products, another FDA-approved product that arehas 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 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 formulationfor 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 2019 fourth quarter, 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.


Table of Contents
Our most advanced proprietary investigational product candidates include:candidate, which we intend to self-commercialize, subject to FDA approval for market access in the U.S., is Libervant.

Libervant™,Libervant is a buccalbuccally, or inside of the cheek, administered soluble film formulation of diazepam useddiazepam.   Aquestive is developing Libervant as aan alternative to the historical device-dependent standard of care rescue therapy for breakthroughpatients with refractory epilepsy, which is a rectal gel. As a result of this route of administration, a large portion of the patient population has not received adequate treatment or has forgone treatment altogether.  We believe that Libervant, if approved by the FDA, will enable a larger share of these patients to receive treatment by providing a non-invasive and innovative treatment form for epileptic seizuresseizures.   The Company filed an NDA for Libervant in November 2019 and an adjunctive therapy for usethe FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020.  A competitive nasal spray product with orphan drug exclusivity was approved in recurrent convulsive seizures, for which a pre-NDA meeting was heldJanuary 2020.  We continue to engage in December 2018the normal course of business interactions, inclusive of responding to information requests, with the FDA. The meeting resulted in a planFDA ahead of the September PDUFA date.  We will seek to complete a small single-dose crossover study comparingdemonstrate that Libervant towill, if approved by the reference listed drug, Diastat®.  This study was initiatedFDA for marketing access in the U.S., represent a “major contribution to patient care” within the meaning of FDA regulations and guidance, as compared to available treatment options,  as the first quarter of 2019,orally non-device delivered diazepam-based product available to manage seizure clusters in epilepsy patients.  However, overcoming the orphan drug marketing exclusivity is difficult to establish, with limited precedent, and enrollment intothere can be no assurance that the study was completed in May 2019.  The Company also began a rolling NDA submission process during the second quarter of 2019. Subsequent to the close of the period, the Company completed the crossover studyFDA will agree with our position and is evaluating the data generated.

Exservan™, an oral soluble film formulation of riluzoleapprove Libervant for the treatment of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDAmarket access in the first quarter of 2019; the PDUFA goal date for FDA approval is November 30, 2019.
U.S.

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

AQST-108, a “first of its kind” oral sublingual soluble film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis and severe allergic reactions, whichusing Aquestive’s proprietary PharmFilm® technologies.  Epinephrine is intended to provide an adjunct and or alternative to injection treatments such as EpiPen.  After the Company’s first human proofstandard of concept trials, a re-formulated and more advanced prototype has been developed, for which we began additional phase 1 proof of concept trials earlycare in the second quartertreatment of 2019;anaphylaxis and
is 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 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 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 another injection device, Auvi-Q, and was well tolerated, with no study participants discontinuing participation due to an adverse event.  We believe that, as a result of its sublingual administration, AQST-108 will improve patient compliance and lower the total cost of care. After a constructive face-to-face pre-IND meeting with FDA in early February 2020, the Company is in the process of preparing the IND for AQST-108 expected to be submitted to the FDA in late June 2020, subject to any delays resulting from the COVID-19 pandemic.  The FDA confirmed that the drug candidate will be reviewed under the 505(b)(2) regulatory approval pathway, and that no additional studies will be necessary prior to opening the proposed IND application.  We expect to begin PK clinical trials later in 2020, subject to any delays resulting from the COVID-19 pandemic.

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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. Asflushing 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 clinicalefficacy 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 results.  We have completed an initial human proof of concept study, and we are further optimizing the formulation.

The COVID-19 pandemic may adversely impact the expected timelines for our clinical trials and studies re-formulation work is currently underway.
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 bothSuboxone.

In early 2019, certain third-party pharmaceutical companies launched, at risk, generic film products for buprenorphine-naloxone.  Also, in early 2019, Indivior, through Sandoz Inc. (“Sandoz”), began to market and sell an authorized generic sublingual film product for Suboxone, which we also exclusively manufactured and supplied.  On October 15, 2019, Indivior publicly announced that, in order to mitigate the impact from the recent passage of H.R. 438- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019, which came into effect on October 1, 2019, and which includes changes to the methodology for calculating average manufacturer price for branded Suboxone, globally throughdrugs, Indivior andhad given notice to Sandoz of Indivior’s intention to cease production of the authorized generic sublingual film formulationproduct.  As of buprenorphinemid-April 2020, Suboxone branded products retain approximately 40% of film market share.  Indivior accounted for 79% and naloxone, through Sandoz88% of our total revenues for the United States market. Asthree-month periods ended at March 31, 2020 and 2019, respectively. Our total revenue mix is expected to shift to a higher proportionate share of July 2019, theseproprietary product sales in future years as we continue to grow Sympazan revenues and pursue the launch of other products accountin our pipeline, assuming FDA approval.  While revenues are expected to decrease in 2020 for greater than 75% of the oral film products prescribedSuboxone, our manufacturing price for Suboxone increased in the U.S. for recoveryfirst quarter of 2020 which is expected to positively impact gross margin contribution from opioid addiction – a market that continues to grow.manufacturing and supply revenue throughout the year.

We manufacture all of our licensed and proprietary products at our FDA- and DEA-inspected facilities. Therefacilities and anticipate that our current manufacturing capacity is no guarantee that proprietary or licensedsufficient 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-pharmaceuticalsince 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. Our products are developed using our proprietary PharmFilm® technology and know-how.  The COVID-19 pandemic could negatively impact our continued commercialization of Symapazan, impact demand for our approved products and development and commercialization of other products in our pipeline.

On July 27, 2018, we closed the initial public offering (“IPO”) and on August 15, 2018, the underwriter’s overallotment option was exercised. A total of 4,925,727 shares of common stock were issued.  On July 25, 2018, theThe Company began tradingtrades on the Nasdaq Global Market under ticker symbol “AQST”. The after having completed its initial public offering and overallotment resulted 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.July 2018.

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.for the purchase of up to 2 million common shares, against which 428,571 common shares were issued in December 2019 upon exercise.  The new financing provided net proceeds of $66,951$66,056 after 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 useused the remaining balancenet 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 Notes are discussed in Note 18, Subsequent Event,13, 12.5% Senior Secured Notes, to our Consolidated Financial Statementscondensed consolidated financial statements included herein and in Liquidity and Capital Resources.

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 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 12.5% Senior Secured Notes. 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-term registration statement, the “baby shelf” registration requirements which may limit the amounts available under the registration statement if its public float falls below certain minimum levels at the time of filing our Annual Report on 10-K.  At this time, the Company is not subject to any such limitation.

We generated revenue of $11,129$8,765 and $13,928$12,643 for the three months ended June 30,March 31, 2020 and 2019, respectively, largely from manufacturing and 2018, respectively, and $23,772 and $37,339 for the six months ended June 30, 2019 and 2018, respectively, most significantlysupply revenues from commercial products licensed to our marketingcollaboration or commercialization licensees. Total revenues also included manufacturinglicensing, royalty and supply revenue, license fees, royalties, co-development and research fees and our proprietary product sales.  Our licensed revenue is subject to the normally uneven nature of the timing of co-development and licensing milestone payments, and to the volumes of product our licensees sell on the market from which we receive royalties and manufacturing revenues. 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,March 31, 2020, we had $22,165$35,521 in cash and cash equivalents. As a result of net losses incurredour investments in product development, recent investments in commercialization initiatives and share-based compensation expenses surrounding the operations2018 initial public offering, among other expenses, as of the Company during the first six months of 2019,March 31, 2020, we had an accumulated deficit of $147,004 resulting in a net shareholders’ deficit of $24,657. We incurred net losses$20,829 as of $20,472 and $36,493 forthat date. For the three months ended June 30,March 31, 2020 and 2019, and 2018, respectively.  For the six months ended June 30, 2019 and 2018, we incurred net losses of $35,198$16,530 and $32,394,$14,726, respectively.  Our working capital, inclusive of cash and cash equivalents, at June 30, 2019 was $14,435.

We expect to continue to incur net losses and negative operating cash flow for at least the foreseeable futurenext 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. OurWe expect our expenses may fluctuate substantiallywill continue to be substantial in 2020 and future periods over time as we:

fundFocus on the approval of Libervant for marketing in the U.S. and, subsequently, if approved, which we cannot assure, its commercialization, investments for Sympazan (launched in December 2018) and, subject to FDA approval, Libervant, our epilepsy products;

continueContinue to clinically develop AQST-108 along the 505(b)(2) pathway with PK clinical development of our complex molecules, AQST-108 and AQST-305;

identify and evaluate new pipeline candidatestrials expected to begin in CNS diseases and other indications; and

fund working capital requirements and expected capital expenditureslate 2020, subject to any delay as a result of the coronavirus pandemic, and

Continue to grow Sympazan sales as a precursor and complement to the eventual launch of proprietary productsLibervant, if approved.

We will 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.

Our business has been financed through a combination of revenue from licensed product and proprietary product activities, proceeds from our IPO, equity investments from our stockholders and debtother equity issuances and proceeds from our credit facilitiesdebt instruments and issuance of our Senior Secured Notes. Our new 12.5% Senior Secured Notes due 2025 and unregistered Warrants issued on July 15, 2019, are discussedfacilities. Significant additional funding is expected to be required in Note 18, Subsequent Event, to our Consolidated Financial Statements and in Liquidity and Capital Resources.  The Warrants include an obligation of the Company to use reasonable best efforts to register the Warrant Shares for resale with the Securities and Exchange Commission within 90 days of the closing and grant customary piggy-back rights to Warrant holders.  As a result of the requirement to register the shares, we will register the warrants and affiliate shares as part of our Universal Shelf Registration that we expect to file later in the third quarter of 2019. The Shelf Registration Statement provides increased capital flexibility as we continueorder to execute our business plan.strategy and operations.

Until we become profitable, if ever, we expect to need to raise significant additional capital through equity or debt issuances, or both, in the future 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 have options to 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 partnered 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) may involve increased restrictive covenants and increased fixed payments or may otherwise further constrain our financial flexibility.  To the extent that we raise additional funds through collaborative or licensing arrangements, it may be necessary to relinquish some rights to our 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 Aquestive’s cash needs.

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. economy 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, financial results and financial condition, and those of our suppliers, distributors, customers and other third parties necessary to our business including those involved in the regulatory approval process, will depend on future developments, which are highly uncertain and cannot be predicted with certainty or clarity, including the duration and continuing severity of the outbreak, additional government actions to contain COVID-19, and new information that will emerge concerning the short-term and long-term impact.

To date, we have been able to continue to manufacture and supply our products and currently do not atanticipate any interruption in supply, although we continue to monitor this time have any current plans to accesssituation 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 equity capital markets.COVID-19 pandemic.

Aquestive is subject to the same risks common to companies
Our office-based employees have generally been working from home since mid-March 2020, while essential staffing levels in similar industries and stages of development,our operations remain on site, including but not limited to, competition from larger companies, reliance 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 reliancein our laboratories and manufacturing locations.  We have also suspended in-person interactions by our sales and marketing personnel and we are engaging remotely to support our commercialization efforts. We are currently expecting to commence our AQST-108 clinical trial in late 2020, although the COVID-19 precautions could directly or indirectly impact timelines, which we will continue to monitor and assess.  For additional information 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.posed 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 20182019 Annual Report on Form 10-K.

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 towill 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 to certain conditions set forth in the JOBS Act, as an “emerging growth company”, we intend to rely on such exemptions and as 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.

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 our commercialized partnered products, licensingproduct development pipeline, marketed product activities and royalty initiatives, development initiatives for third parties and sales of self-developed medicines. 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 of the manufactured product. 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 in or ability to participate in commercialization including marketing, pricing, sales and regulatory strategy.

We expect future manufacture and supply revenue from licensed activitiesproducts to be based on volume demand for such licensed products and manufacturing and supply rights under new collaborations for product development and additional licensing of our intellectual property.

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 from our co-development and research activities, including with our licensees, we may out-license to our licensees the rights to utilize our intellectual property related to their marketing of such products. As a result, we earn revenue from license fees received under such license, development and supply agreements. 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.

Proprietary Product Sales

As we commercialize our proprietary CNS product candidates for which we receive regulatory approval to market such product beginning with Sympazan, as well as Libervant, subject to regulatory approval, we expect tomay directly market our productssell such product to consumers in the United States, resulting in an additional source of revenue which we refer to as Proprietary Product Sales.proprietary product sales. 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 a collaborator to commercialize our product candidates in certain markets inside and outside of the United States. 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 are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, rebates and co-pay cardsupport redemptions, each of which are described in more detail below. 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 includesrecords 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.

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 suchwhich 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 andthird-party managed care, 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 waswere based in part byon 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 CardsSupport Programs

Co-pay card redemptionssupport 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 and the regulatory approval process for our pipeline of proprietary product candidates; and selling, general and administrative expenses, including pre-launch and post-launchpost launch commercialization efforts related to our CNS product candidates, intellectual property procurement, protection, prosecution and litigation expenses, corporate management functions, 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 of costs and expenses related to manufacturing our proprietary dissolving film products for our marketed licensed pharmaceutical products and for our newly approved proprietary products including raw materials, direct labor and fixed overhead 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 principally consists 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 amount of direct labor and materials required to produce a product and the allocation of fixed overhead, which is dependent on the levels of production.

We will continue to seek to rationalize and reduce costs to reflect the declining production volumes of Suboxone. Our production cost of manufacturing and supply increased in late 2019 resulting from declining volume of Suboxone that began in 2019 and continues to decline in 2020.We expect our manufacture and supply costs and expenses to increasedecrease over the next several years due to the decline in Suboxone volumes as the generics in that market continue to take market share, modestly offset by the commercialization of our proprietary products, starting with the launch of Sympazan launched in December 2018 and2018.  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 maywould incur increased costs associated with hiring additional personnelpersonal to support the increased manufacturing and supply costs arising from our commercialization of these productshigher 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.

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;
third-parties, such as contract research organizations, investigational sites and consultants;

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

costs associated with preclinical and clinical activities and regulatory operations.

We expect our research and development expenses to increasecontinue to be significant over the next several years as we continue to develop existing product candidates such as AQST-108 and we expand our efforts to 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 legal, 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 selling, general and administrative expenses have been focused primarily on corporate management functions along with unabsorbed factory overhead costs. However, costsCosts related to the commercialization of our CNS product candidatesproducts began in the second half of 2017 and significantly increased in 2018 as we progressed towardleading up to the launch of Sympazan in December 2018,2018. Significant investments in commercialization were made in 2019.  We will continue to invest in the commercialization of Sympazan in 2020 but those costs will be rationalized to the expected near-term opportunity Sympazan represents.  In the later part of the year we would expect additional expenses to occur in order to launch Libervant should it be approved.

Sympazan is the precursor and began initial preparations forcompliment to the launch of Libervant if it is approved and granted access to market.  There is a very high degree of overlap and correlation between prescribers of Sympazan and the likely prescribers of an additional late-stageapproved Libervant.  While Sympazan continues to grow, we will continue to rationalize its contribution as a product and its value as a way to introduce prescribers to the epilepsy product currentlymarket, to Aquestive and PharmFilm® technology and the investment we are making in this form of commercialization and marketing spend supporting it. The current commercial organization would launch Libervant, subject to FDA approval.  Theseits approval, without expecting to immediately add significant internal personnel costs are expectedalthough marketing and selling expenses will increase if Libervant is approved and ready to be marketed.  Until any Libervant launch is clear, we do not plan to increase in 2019, with a full year effectthe costs of Sympazan’s commercialization.  Incremental marketing spending in preparation for theour commercial launch of Libervant is expected to be incurred prior to the PDUFA date for this productorganization and will be accordingly planned oncecontinue to improve the PDUFA date is known. As partefficiency of the Sympazan 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 expected 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 the future launch, subject to FDA approval, of Libervant.  investments.

Our general and administrative costs increased after 2017 as a result of becoming a public company, including costs related to additional personnel and accounting, audit, legal, regulatory and tax-related services with maintaining compliance with exchange listing and otherSEC requirements, director and officer insurance costs, and investor and public companyrelations costs.  In addition,We continue to incur significant costs in orderseeking to better alignprotect our selling, general and administrative expensesintellectual property rights, including significant litigation costs in connection with expected revenue, during the second quarter we reviewed and began initiativesseeking to reduce certain expenses in non-core functions, and weenforce our rights concerning third parties’ at-risk launch of generic products.

We will continue to reviewmanage the business costs to appropriately reflect the declining Suboxone revenue, the marketing and assesssales costs related to Sympazan and other external factors affecting our selling, generalbusiness including the continuing impact of the COVID-19 pandemic, as we continue to focus on the core drivers of value to our stockholders:

Seeking to obtain the approval and administrative expenses relativesubsequent launch of Libervant, subject to planned revenues going forward.approval for marketing in the U.S.;

The continued, accelerated development of AQST-108 along the 505(b)(2) pathway with PK clinical trials expected to begin in late 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 related to our debt facility, as well as amortization of loan costs and debt discount. Our interest cost, which under our Perceptive credit facility was subject to changes in one-month LIBOR, representsrepresented a monthly cash payment obligation.  Our newSenior Secured Notes are discussed in 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 increasehas increased based on additional borrowings under such new Notes.  Under the new facility, interest is fixed at 12.5% and is payable quarterly.

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 thatThere is expectedno minimum amount to be applied to operating costs as needed.

Change in Fair Value of Warrant

Changesmaintained in the fair valueaccount nor any fixed length 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.period for which interest is earned.

Results of Operations

Comparison of the Three Months Ended June 30,March 31, 2020 and 2019 and 2018

We recorded revenue of $11,129$8,765 and $13,928$12,643 in the three months ended June 30,March 31, 2020 and 2019, and 2018, respectively, generating a net losslosses of $20,472$16,530 and $36,493$14,726 for the three months ended June 30, 2019 and 2018,each of those periods, respectively.

Revenues:

 
Three Months Ended
June 30,
 Change  
Three Months Ended
March 31,
  Change 
(In thousands, except %) 2019 2018 $  
% 
 2020  2019  $  
% 
(in thousands, except %)            
Manufacture and supply revenue $8,915  $8,684  $231   3% 
$
6,916
  
$
6,669
  
$
247
  
4%

License and royalty revenue  424   4,532   (4,108)  (91%) 
426
  
4,622
  
(4,196
)
 
(91%
)
Co-development and research fees  1,019   712   307   43% 
263
  
770
  
(507
)
 
(66%
)
Proprietary product sales, net  771   -   771   100%  
1,160
   
582
   
578
  
99%

Total revenues $11,129  $13,928  $(2,799)  (20
%)
Revenues
 
$
8,765
  
$
12,643
  
$
(3,878
)
 
(31%
)

For the three months ended June 30, 2019,March 31, 2020, total revenues decreased 20%31% or $2,799$3,878 to $11,129$8,765 compared to revenues of $13,928$12,643 for the same period in 2018.2019. The change is primarily attributable to differencesdecreases in license and royalty revenue that by nature are variable as to timing and magnitude.  Additionally, under the Indivior Supplemental Agreement licensein co-development and research 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 offset in part by increasesincrease in manufacture and supply revenue co-development and research fees and proprietary product sales revenue from Sympazan, launched in December 2018.revenue.

Manufacture and supply revenue increased approximately 3%4% or $231$247 to $8,915$6,916 for the three months ended June 30, 2019March 31, 2020 compared to $8,684$6,669 from the prior year period. This increase is attributable to slightly higherincreased pricing associated with our Suboxone product mix of higher margin dose configurationsaffecting the current period offset in part by 1.8 million fewer strips sold28% total lower volumes of Suboxone and the Suboxone authorized generic period over period.  As discussed above, Indivior announced in the fourth quarter 2019 the cessation of the early partsale and marketing of third quarter 2019, Suboxone and itsthe authorized generic, maintained a greater than 75% sharewhich has impacted our manufacturing and supply revenue in the market.  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 growthree months ended March 31, 2020 and wethis decision will continue to closely monitor these dynamicsimpact revenues throughout 2020.  The branded Suboxone products, currently holding approximately 40% of the film market, have continued to experience market share erosion as generic competition continues to take more market share following the U.S. court of appeals lifting a preliminary injunction in February 2019 allowing generic competitors into the marketplace.U.S. Suboxone market “at risk” while patent infringement cases against those generic manufactures are tried to conclusion.  We continue to plan for the further erosion of this sunsetting product over time.

License and royalty revenue decreased 91% or $4,108$4,196 to $424$426 for the three months ended June 30, 2019March 31, 2020 compared to revenues of $4,532$4,622 from the prior year period. This change was primarily related to the timing of license and new patent fees on our licensed product Suboxone.  LicenseThe Company did not record any license fees totaled $0from Indivior for the three months ended June 30, 2019March 31, 2020 compared to $4,250 of license fees recognized during the prior year comparative period. Suboxone related license fees were $4,250 lower compared to 2018, as a result of2019, primarily due to the fact that certainall 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 wereremained 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 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.

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, 2018 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.

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 and 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 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 decreased 42%66% or $1,274$507 to $1,789$263 for the sixthree months ended June 30, 2019March 31, 2020 compared to $3,063$770 from the prior year period. The decrease was driven by the timing of the achievement of research and development performance obligations on licensed productsresearch and development projects and related milestones both of whichand are normally expected to fluctuate significantly one reporting period to the next.

ProductProprietary product sales, net increased $1,353$578 or 100%99% to $1,160 for the sixthree months ended June 30, 2019March 31, 2020 compared to $582 from the prior year period, due to the launch of our first proprietary self-developed medicine,increased Sympazan in December 2018.prescriptions written by CNS physicians and improved payor approval rates.

Expenses and Other:
 
Six Months Ended
June 30,
  Change  
Three Months Ended
March 31,
  Change 
(In thousands, except %) 2019  2018  $  
% 
Manufacture and supply 
$
8,926
  
$
10,609
  
$
(1,683
)
 
(16
)%
 2020  2019  $  
% 
(in thousands, except %)            
Manufacturing and supply
 
$
3,659
  
$
3,506
  
$
153
  
4
%
Research and development 
12,454
  
12,895
  
(441
)
 
(3
)%
 
4,354
  
4,303
  
51
  
1
%
Selling, general and administrative 
34,154
  
41,213
  
(7,059
)
 
(17
)%
 
14,613
  
17,908
  
(3,295
)
 
(18
%)
Interest expense 
3,863
  
3,876
  
(13
)
 
0
%
 
2,771
  
1,926
  
845
  
44
%
Interest income 
(427
)
 
(22
)
 
405
  NM  
(102
)
 
(274
)
 
(172
)
 
(63
%)
Other 
-
  
1,162
  
(1,162
)
 NM 

ManufactureManufacturing and supply costs and expenses decreased 16%increased 4% or $1,683$153 to $8,926$3,659 for the sixthree months ended June 30, 2019March 31, 2020 compared to $10,609$3,506 for the same period in 2018.2019. This decreaseincrease was primarily driven by lower productionhigher standard product costs due to theper unit offset in part by 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.Suboxone production.

Research and development expenses decreased 3%increased 1% or $441$51 to $12,454$4,354 for the sixthree months ended June 30, 2019March 31, 2020 compared to $12,895$4,303 in the prior year period. This net expense reduction wasResearch and development expenses are driven primarily by the resulttiming of a net decrease of share-based compensation expenses of $1,845 due primarily to the one-time settlement in 2018 ofclinical 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.

Selling, general and administrative expenses decreased 17%18% or $7,059$3,295 to $34,154$14,613 for the sixthree months ended June 30, 2019March 31, 2020 as compared to $41,213$17,908 for the prior year period. The decrease was from two primary areas:  commercial expenses and unabsorbed factory overhead expenses.  Commercial expenses are lower in the first quarter of 2020 by approximately $2.2 million as the first quarter of 2019 included significant initial launch expenses for Sympazan that did not repeat in 2020, and from the company’s efforts to manage costs and capital runway.  Unabsorbed factory overhead expenses are lower by about $2 million reflecting the company’s efforts to reduce the costs of plant operations while production volumes decline as a result of Suboxone erosion.  These reductions were partially offset by higher insurance premiums and share-based compensation expense.

Interest expense increased 44% or $845 to $2,771 for the three months ended March 31, 2020 as compared to $1,926 for the same period in 2019. This decrease is primarily due to $24,767 in compensation costthe result of $20,000 of additional outstanding debt and related higher loan acquisition costs and debt discount associated with the issuance of the non-voting common shares and related withholding taxes allocableour Senior Secured Notes.  Prior to selling, general and administrative expenses offset in part by $7,692 of higher investments inJuly 15, 2019, 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 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.

Interest expense remained flat for the six months ended June 30, 2019 compared to the same period in 2018. Our interest expense was subject to fluctuations based on one-month LIBOR.LIBOR and was approximately 12% to 12.5%.  Our new Senior Secured NoteNotes due 2025 issued on July 15, 2019 carry a 12.5% fixed interest rate per annum.

Interest income increased $405decreased 63% or $172 to $102 for the sixthree months ended June 30, 2019March 31, 2020, compared to $274 of interest income for the same period in 2019. This decrease is a result of investing lower net cash balance in the first quarter of 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,March 31, 2020, we have a net stockholders’ deficit of $24,657.$20,829. We have funded our operations primarily with equity and debt financings and manufacture and supply revenue as well as milestone and royalty payments from our licensees.collaboration licensees and manufacturing and supply revenue.

We generate revenue from licensed products and proprietary product sales, net 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 and interest expenses have resulted in the $147,004 deficit we have accumulated from inception.

We had $22,165$35,521 in cash and cash equivalents as of June 30, 2019 and working capital, including cash and cash equivalents,March 31, 2020. We have no committed sources of $14,435.capital.

Credit Agreement and GuarantyEquity Offering

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 closingcompleted an underwritten equity offering of our IPO, Perceptive received 863,4008,050,000 shares of common stock issuable pursuant to the automaticour S-3 Registration Statement, including exercise of warrants for a total exercise pricethe underwriter’s over-allotment option, resulting in gross proceeds of $116.approximately $40,250 before underwriter discounts and other costs and expenses and net proceeds were $37,295.

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.

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 fulloutstanding 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 useused the remaining net cash balanceproceeds of approximately $14,859$13,110 for the continued commercialization and advancement of itsour proprietary products and pipeline candidates, and other general corporate purposes.

The additional notesSenior Secured Notes can be issued if the Company satisfieswe satisfy certain conditions and achievesachieve certain milestones related to the filing and approval of itsour 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 haswe have the option to issue an additional $10,000 aggregate principal amount of the Senior Secured Notes if the Company haswe filed a new drug application for itsour candidate Libervant with the FDA prior to that date, provided it haswe 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 notesSenior 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 30th, June 30th, September 30th and December 30th 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 NotesSenior 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 hasIndenture, we have the right to monetize itsour royalty and milestone interests in Sunovion’sour licensed product, Apomorphine product APL-130277, oncewhich would not be expected prior to the NDA for such product is approved byanticipated May 21, 2020, FDA approval of the FDA.product.  Upon any such monetization we shallare 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 a majority in aggregate principal amount outstanding under the Notes.  See Note 13, 12.5% Senior Secured Notes, to our Condensed Consolidated Financial Statements.  To the extent that the holders of the Note 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 are specified in the Indenture are considered typical for loans of this nature, including, but not limited to, specificationsrequirements 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 perfectionsuch 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 paymentgenerally, mandatorily redeemable securities or other obligations, compliance with regulatory requirements and preservationsecurities redeemable at the option of the corporate existence and business operationsholder 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 newthis financing, we agreed to issueissued to the new noteholders unregisteredholders of the Notes, Warrants to purchase up to an aggregate of 2,000,000 sharesshare 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 changeand associated shares as part of control provisionsour S-3 Registration.  The were no Warrants exercised in the three-month period ended at March 31, 2020.

Credit Agreement and are exercisableGuaranty

On August 16, 2016, we entered into a Credit Agreement and Guarantee with Perceptive Credit Opportunities Fund (“Perceptive”), which we amended on a “cashless” basis.  The Warrants includeMay 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 Commissionadditional $5,000 within 90 daysone 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 rightsreceived 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.

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.

Upon the closing of the IPO, Perceptive received 863,400 shares of common stock issuable pursuant to the holdersautomatic exercise of warrants from APL’s ownership interests 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.

Cash Flows

Six
Three Months Ended June 30,March 31, 2020 and 2019 and 2018

(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
 
$
(13,637
)
 
$
(17,680
)
Net cash (used for) investing activities 
(486
)
 
(886
)
 (131
)
 
(376
)
Net cash (used for) financing activities 
(3,102
)
 
(7,151
)
  
(37
)
  
(2,609
)
Net decrease in cash and cash equivalents 
$
(38,434
)
 
$
(6,741
)
 
$
(13,805
)
 
$
(20,665
)

Net Cash (Used for) Provided by Operating Activities

Net cash used for operating activities for the sixthree months ended June 30, 2019March 31, 2020 was $34,846.$13,637.  The use of cash can be understood as represented by three mainmajor factors: (1) our net loss of $35,198,$16,530, (2) decrease in operating assets and liabilities of $5,822,$294 partially offset by (3) non-cash operating expenses. The non-cash operating expenses of $6,174$3,187 primarily resulted from $3,330$1,860 of share-based compensation expense recorded in the six months ended June 30, 2019.first quarter of 2020.  Other significant components included non-cash charges of $2,844$1,327 related to non-cash charges such as depreciation, amortization and amortization of debt issuance costs.

Net cash provided byused for operating activities for the sixthree months ended June 30, 2018March 31, 2019 was $1,296.$17,680.  The provisionuse of cash can be understood as represented by three mainmajor factors: (1) our net loss $14,726, (2) decrease in operating assets and liabilities of $6,128 partially offset by (3) non-cash operating expenses.  The non-cash operating expenses of $31,204, which$3,174 primarily resulted from $1,520 of share-based compensation expense recorded in the first quarter of 2019.  Other significant components included $27,305non-cash charges of $1,654 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 in warrant valuation, (2) changes in working capital accounts totaling $2,486, primarily through collectionscosts.

33


Net Cash (Used for) Investing Activities

Net cash used for investing activities was $486$131 for the sixthree months ended June 30, 2019March 31, 2020 compared to $886$376 for the sixthree months ended June 30, 2018.at March 31, 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 $3,102$37 for the sixthree months ended June 30, 2019March 31, 2020 compared to $7,151$2,609 for the sixthree months ended June 30, 2018.at March 31, 2019.  The cash used in 2020 is a result of payment for withholding taxes on share-based compensation.  The cash used in 2019 is primarily thea 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 principal payment made during May 2019 related to the Credit Agreement and Guaranty, offset in part by $112 of proceeds derived from common stock purchased by eligible employees through 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.

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 at anticipated levels, cash on hand, and, the net proceeds from the issuance of our 12.5% Senior Secured Notes due 2025 issued on July 15, 2019 and, assumingsubject to satisfaction of all conditions to and requirements for further senior secured notes issuances of additional senior secured notes,our Senior Secured Notes, and assuming available purchasers thereof, potential additional proceeds from future issuances of up to $30,000 of additional Senior Secured Notes, andthe net proceeds from our equity offering of common stock in December 2019,  potential future monetization of certain royalty streams or other license rights such as apomorphinefor Apomorphine (subject to all conditions and requirements under the indenture),Senior Secured Notes Indenture and market conditions which may be impacted by the COVID-19 pandemic) and if needed and available to the Company, further access to the capital markets 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 will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

The key assumptions underlying this expectationour funding expectations for the next 12 months include:

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

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

our ability to issue on or before March 31, 2021, and available purchasers of, additional senior secured notes in an aggregate amount up to $30,000 principal amount under the indenture for our 12.5% Senior Secured Notes due 2025, based on satisfying certain conditions including approval of our Libervant proprietary product, and approval of the first reopener by a majority of the holders of the Senior Secured Notes, (see “12.5% Senior Secured Notes” above);

potential monetization ofmonetize royalty streams or other license or proprietary rights for our product candidate Apomorphine at anticipated levels, which cannot be assured (and which areis subject to conditions and requirements under the indentureIndenture for our new 12.5% Senior Secured Notes including note repurchase obligations at 112.500%112.5% of principal amount of such repurchased notes and accrued and unpaid interest thereon, at the option of the holders)holders (see “12.5% Senior Secured Notes” above)) and which monetization would not be expected prior to FDA approval of this drug candidate;
access to the capital markets if and at the time needed for any necessary future funding;
continuing review of our cost structure and cost and expense reductions consistent with our anticipated revenues and funding;
our ability to 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 which we cannot assure (see “12.5% Senior Secured Notes” above);

continued funding of ourappropriate 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 CNSour 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 12.5% Senior Secured Notes;Notes, and

absence of significant unforeseen cash requirements.
We commercially launched our first proprietary product Sympazan in late 2018, and 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 the anticipated launch of Libervant after approval by the FDA.  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 proprietary products and 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 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.
We will continue to manage business costs to appropriately reflect the declining state of Suboxone revenues, the marketing and sales costs related to Sympazan 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 of Libervant and AQST-108, research and development activities, pre-clinical activities, clinical trials, regulatory approval activities and commercialization activities.  We will continue to seek to rationalize our costs as Suboxone revenue declines.  Additionally, we will 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.
Our cash resources on hand are not sufficient by themselves to fund our expected development, commercialization and other operations and activities, and we expect to continue to require external sources of funding and capital to develop and seek regulatory approval of our product candidates and for the commercialization of our approved products.  The amount and timing of our future requirements, both short-term and long-term, will depend on many factors, including:
Our ability to achieve successful commercialization growth of our proprietary product Sympazan and the cost and timing of our future commercialization activities;

Continued revenues at planned levels from our manufacture and sale of branded Suboxone to Indivior and continued market acceptance of such branded product, without any sales of the authorized generic version of Suboxone;

Sunovion Pharmaceuticals, Inc (“Sunovion”), to whom we out-licensed our technology, achieving regulatory approval of Apomorphine on May 21, 2020 which is expected to provide the opportunity for a significant non-dilutive capital source for us;
Achieving U.S. marketing regulatory approval in the time period we have anticipated of our product candidate Libervant which has been part of our business plan and strategy.  We completed the filing of our NDA for Libervant with the FDA in the fourth quarter of 2019, and the FDA has granted a PDUFA goal date of September 27, 2020, although there can be no assurance we will obtain such approval;
Continuing significant costs in seeking to protect our intellectual property rights, including significant litigation costs in connection with seeking to enforce our rights concerning third parties’ at-risk launch of generic products;
Patient and doctor acceptance of and our ability to obtain adequate reimbursement for our products which we commercialize;
The effect of competing products, including generic products, on our commercialized and licensed products, including Suboxone;
All other costs of executing our business plan and absence of unforeseen cash requirements; and
The risks and uncertainties associated with the coronavirus pandemic.
The sufficiency of our short-term and longer-term liquidity is directly impacted by our level of operating revenues and our ability to achieve our operating plan for revenues, regulatory approval in the time period planned of our late-stage proprietary products and our ability to monetize in the time planned our royalty streams or other license rights such as apomorphine.Apomorphine.  We also are entitled to further potential milestones, royalty and other payments under our Indivior Supplemental Agreement, which are suspended and may only be reinstated if Indivior successfully adjudicates or settles the related patent infringement litigation. Therelitigation, and there is no assurance when or if any such payments may be due.  Our operating revenues have fluctuated in the past and can be expected to fluctuate in the future.  We expect to incur significant operating losses and negative operating cash flowflows for the foreseeable future, and we have a significant level of debt on which we have substantial ongoing debt repayment and debt service obligations.  A substantial portion of our current and past revenues has been dependent upon our licensing, manufacturing and sales with one customer, Indivior, which is expected to continue while we commercialize our own proprietary products and whichit could take significantly longer than planned to achieve anticipated levels of cash flows to help fund our operations and cash needs from sales levels.of our proprietary products other than Suboxone.

Management will continue to monitor the Company’s cash requirements and liquidity, and, if management believes operating results, including expected revenue from manufacture and supply sales and proprietary sales, expected license and milestone revenues, any available proceeds from any future issuances of additional Notes under the Indenture for our Senior Secured Notes and from any monetization of royalty streams or other license rights, reductionsany future potential issuances of additional Senior Secured Notes under the Indenture, reduction in cash spend, other availablenet proceeds of future debt or equity financing, if needed and available to it, which cannot be assured, or other future access to the capital markets under our shelf registration statement filed with the SEC and effective September 17, 2019 or other potential available sources of liquidity and, if management believes operating results and the above funding sources are not sufficient or available for existing or projected cash requirements, management will seek to take further steps intended to improve the Company’s financial position and liquidity, such as by modifying our operating plan, adjusting the timing and scope of our development activities, seeking to further to reduce costs and adjusting cash spend and evaluating and pursuing other potential opportunities or alternatives to obtain additional liquidity.

On July 15, 2019 we issued $70,000 aggregate principal amount of our 12.5% Senior Secured Notes due 2025 and related Warrants, resulting in approximately $66,951 in note proceeds, after transaction expenses.  In connection with the issuance of the Senior Secured Notes, we repaid approximately $52,092 representing all amounts outstanding or due under our Perceptive debt facility.  In addition, the indenture governing the senior secured notes provides opportunity to potentially issue in the future up to an aggregate of $30,000 of additional Senior Secured Notes based on our satisfaction of certain conditions and requirements under the indenture and having available purchasers of such additional Senior Secured Notes.  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 not to exceed $10,000 (the “ABL Facility”).  The ABL Facility may be collateralized by assets constituting only inventory, accounts receivable and the proceeds of the Company.  See “12.5% Senior Secured Notes” above.

In the future we may attempt to pursue additional capital financing if deemed appropriate or if needed for liquidity requirements, or when strategic opportunities might become available.  UntilUnless and until we become profitable, if ever, we expect towill continue to need to raise additional capital and/or incur debt in the futureother financing or funding, any of which could be material, to further the commercialization of Sympazan and advance the development of our other product candidates, most importantly Libervant and AQST-108, which are subject to regulatory approval, and commercialization of our CNS products including Libervant, and of our other product candidates and to meet our other cash requirements, including debt service.  We do not currently have any committed external sources of financing.
Our ability to secure additional equity financing could be significantly impacted by numerous factors including our operating performance and prospects, positive or negative developments in the regulatory approval process for our proprietary products, timely achievement of regulatory approval of our late-stage proprietary products, our existing level of debt which is secured by substantially all of our assets, restriction under our Senior Secured Note Indenture, and general market conditions, and there can be no assurance that such neededwe will continue to be successful in raising capital or debtthat any such needed financing will be available, available on favorable or acceptable terms or at the times or in the amounts needed.  Additionally, while the potential economic impact brought on by and the duration of the coronavirus pandemic is difficult to assess or predict, the significant impact of the coronavirus pandemic on the global financial markets, and on our own stock trading price, may reduce our ability to access additional capital, which would negatively impact our short-term and longer-term liquidity.
We may also seek to obtain additional funding in the future through the monetization of royalty streams from our product Apomorphine, subject to our licensing agreement withregulatory approval thereof, which product candidate is licensed to Sunovion Pharmaceuticals, Inc. (and subject to the conditions and requirements under the indentureIndenture for our 12.5% Senior Secured Notes due 2025 including our note repurchase obligations at the option of the holders), but we cannot be assuredassure of any such royalty streams or monetization.
Our ability to obtain any additional indebtedness or other debt financing is limited by the terms of the Indenture and the Indenture also restricts or prohibits certain types of equity financing (see “12.5% Senior Secured Notes” above).  To the extent we are able to obtain needed funding through additional debt financing, any such debt financing may be coupled with an equity component, such as warrants for our shares, which could also result in dilution to our stockholders.  The incurrence of additional debt would also result in increased fixed payment obligations.

We may also seek to obtain additional funding through the issuance of our common stock, and, subject to restrictions under the indenture for the Senior Secured Notes, other public or private equity or debt financings, third-party funding, marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches.  We may not be able to raise additional capital or financingother funding on terms acceptable to us, or at all, and any failure to raise additional capital or financingother funding as and when needed for our cash requirements would likely compromisehave a negative impact on our business prospects and financial condition and our ability to execute onand achieve 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 maywould experience dilution.further dilution and the terms of these securities could include liquidation or other preferences (if and to the extent permitted under the Indenture) that would adversely affect our stockholders’ rights.  To the extent that we raise additional funds through collaborative, strategic alliances or licensing arrangements with third -parties, it may be necessary to relinquish some(subject to required consent under our Indenture for the disposition or transfer of assets other than Apomorphine) valuable rights to our intellectual property or future revenue or grant licenses on terms that are not favorable to us.us or that we may not otherwise consider relinquishing or granting, including rights to future product candidates.  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 liquidity and funding position.

If adequate funds are not available for our short-term or longer-term liquidity needs and cash requirements as and when needed, we may be required to reduce staff, delay, reduce the scopesignificantly scale back, or even discontinue some or all of or eliminate our research and development programs and clinical and other product development activities, or reduce our planned commercialization efforts orand otherwise significantly reduce our other spend and adjust our operating plan, and we would need to seek to take other steps intended to improve our liquidity.  We also may be required to evaluate additional licensing opportunities, if any become available, of our proprietary product candidate programs that we currently plan to self-commercialize or explore other potential liquidity opportunities or other alternativesalternative or options or strategic alternatives, although we cannot assure that any of these actions would be available or available on reasonable terms.

Our costs associated with operating as a new public company have increased, and we expect to incur additional costs to support the obligation of a public company to various regulatory agencies, to investors and in order to comply with certain legislation and regulations.  These expenditures include the costs of additional employees, with specific skills and experiences such as SEC reporting, higher insurance expense and internal controls as well as additional costs to outside service providers such as audit, tax, and legal fees.

See also Part II.II, Item 1A, Risk Factors below concerning Indiviorthe significant risks and recent criminal proceedings in connectionuncertainties concerning the Company’s business, operations, financial results and capital resources associated with it allegedly and deceptive and misleading practices related to its marketing and distributionthe impact of its Suboxone film product, dating back a number of years.  We have to date not experienced any significant reduction in purchase orders from Indivior for the manufacture and supply of Suboxone film products, other than what we believe it attributable to the entry of at-risk generics.global coronavirus pandemic.

Off-Balance Sheet Arrangements

During the period presented, there were nowe did not have any material changes in our operating leases, our only off-balanceoff balance sheet arrangements, nor do we have any relationships with unconsolidated entities or financial partnerships, such as defined in the rules and regulations of the SEC.entries often referred to as structured finance or special purpose entities.

Item 3.
Quantitative and Qualitative Disclosures about Market Risk

Prior to July 15, 2019, our exposure to market risk due to changes in interest rates relatesrelated primarily to the increase or decrease in the amount of interest expense from fluctuations in one-month LIBOR associated with our debt facility.  For each 1% increase in one-month LIBOR in excess of the floor of 2%, our annual interest expense would increasehave increased by approximately $500,000.  However, our new Senior Secured Notes due 2025 issued on July 15, 2019, carry a 12.5% fixed interest rate per annum, thereby eliminating market risk due to changes in interest rates.  Our cash and cash equivalents are maintained in FDIC protected accounts with no exposure to material changes in interest rates. At March 31, 2020, our interest rate on deposited cash was 0.35%.  We do not purchase, sell or hold derivatives or other market risk sensitive instruments to hedge interest rate risk or for trading purposes.  We areFurther, we do not invest in any common stock or debt instruments that have been affected by the process of developing a comprehensive investment strategy for our cash and cash equivalents whose underlying premise would be to preserve principal while atglobal COVID-19 outbreak which has resulted in material market movements during the same time maximizing the income that we received from our investments without significantly increasing risk.quarter ended March 31, 2020.

Our accounts receivables are concentrated predominantly with Indivior.  See Quarterly Report on Form 10-Q forWith the period ending June 30, 2019, Part III, Item 1A, Risk Factors concerning Indivior.

With ourrecent launch of Sympazan, in December 2018, our concentration with three large national wholesalers of pharmaceutical products is not significant presently but may become so in future periods should Sympazan sales increase and should other pipeline products become approved by the FDA and become distributed through these three national,regional, or other, wholesalers. In the event of non-performance or non-payment by either Indivior or the wholesalers, there may be a material adverse impact on our financial condition, results of operations or net cash flow.

Item 4.
Controls and Procedures.

Management’s Evaluation of our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in ourthe reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is(2) accumulated and communicated to us,our management, including to our Chief Executive Officerprincipal executive officer and Chief Financial Officer, as appropriate,principal financial officer, to allow timely decisions regarding required disclosure.  In designing

As of March 31, 2020, our management, with the participation of our principal executive officer and evaluatingprincipal financial officer, evaluated the effectiveness of our disclosure controls and procedures we recognize(as defined in Rules 13a-15(b) and 13a-15(e) under the Exchange Act).  Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired controltheir objectives, as ours are designed to do, and wemanagement necessarily were required to apply ourapplies its judgment in evaluating whether the benefitscost-benefit relationship of thepossible controls and proceduresprocedures.  Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, we adopt outweigh their costs.

As required by Rule 13a-15(b) of the Exchange Act, an evaluation as of June 30, 2019 was conducted under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness ofMarch 31, 2020, our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures, as of June 30, 2019, were effective forat the purposes stated above.reasonable assurance level.

Internal Control Over Financial Reporting

There waswere no changechanges in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act), identified in connection with the evaluation of such internal control that occurred during our most recentlast fiscal quarter, that hashave materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitation on Effectiveness of Controls

Our management, including the Chief Executive Officer and Chief Financial Officer, believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the control system are met.  Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.  Because of the inherent limitations in all control systems, they cannot provide absolute assurance that all control issues and instances of fraud, if any, within Aquestive have been prevented or detected.  These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes.  Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by unauthorized override of the control.  The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.  Accordingly, because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and many not be detected.

PART II – OTHER INFORMATION

Item 1.
Legal Proceedings

From time to time, we have been and may again become involved in legal proceedings arising in the course of our business.

Patent-Related Litigation

Beginning in August 2013, we were informed of ANDAabbreviated 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. We 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 us,the Company, Indivior, and Par and certain of its affiliates.

Actavis was found to infringe Patent No. 6,603,514, 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 Third Circuit (“Federal CircuitCircuit”) 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.

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 caseA 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 scheduledNew 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 Court’s claim construction ruling, and we and Indivior preserved our 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 us and Indivior.  We 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, we 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.  No trial date has been set in those cases.  We are not able to determine or predict the cases against DRL and Alvogen, which are pendingultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcomes or losses, is any, in the U.S. District Court for the Districtthis matter.

On February 19, 2019, the Federal Circuit issued its mandate reversing the District of New Jersey’s preliminary injunction against DRL.Dr. Reddy’s.  Following issuance of the mandate, the District of New Jersey vacated preliminary injunctions against both DRLDr. Reddy’s and Alvogen.  On February 19, 2019, Indivior launched the authorized generic of Suboxone Sublingual Film, which we manufacture 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 DRLDr. Reddy’s and Alvogen are “at risk” because the products are the subject of the ongoing patent infringement litigations.

On March 22, 2019, we and Indivior brought suit against Aveva Drug Delivery Systems, Inc., Apotex Corp., and Apotex 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. Patents Nos.  8,017,150, 9,687,454, the ’514 ’454,patent and the ’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 andCourt 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.

We are also seeking to enforce our patent rights in multiple cases against BioDelivery Sciences International, Inc. (“BDSI”). TwoThree 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.

The second was filed by us and Indivior related to BDSI’s infringing Bunavail product, and alleges infringement of our patent, U.S. Patent No. 8,765,167, or the ’167 patent, and seeks an injunction and potential monetary damages. Shortly after the case was filed, BDSI filed four IPRs(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, we and Indivior submitted a notice to the Court on February 15, 2019 notifying the Court that the stay should be lifted as a result of the PTAB’s decisions. We are awaiting further action from the Court.

On January 13, 2017, we also sued BDSI asserting infringement of the ’167 patent by BDSI’s Belbuca product and seeking an injunction and potential monetary damages.  Following the PTAB’s FebruaryOn August 7, 2019, decisions on remand denying institution, the Company submitted a noticeEastern District of North Carolina Court granted BDSI’s motion to dismiss the Court on February 15, 2019 notifying the Court thatComplaint without prejudice and denied BDSI’s motion to stay should be denied as moot.  On November 11, 2019, we filed a new Complaint against BDSI also sentin the Eastern District of North Carolina Court.  On November 27, 2019, BDSI filed a lettermotion to stay the Court on February 13, 2019 indicating its intent tocase pending BDSI’s appeal of the PTAB’s decisions.remand decisions, and we opposed the motion.   The parties are awaiting further action from the Court.  BDSI appealedEastern 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 FederalUnited State Court of Appeals for the Fourth Circuit (the “Federal Fourth Circuit Court”) was docketed on March 13, 2019, and on March 20, 2019, we moved to dismiss the appeal for lack of jurisdiction.
  On August 29, 2019, the Federal Fourth Circuit Court granted the motion to dismiss BDSI’s appeal.  On September 30, 2019, BDSI filed a petition for rehearing in the Federal Fourth Circuit Court en banc, which we opposed.  The Federal Fourth Circuit Court denied BDSI’s petition for rehearing en banc on January 13, 2020. After the Federal Fourth Circuit Court 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 we opposed the motion on February 2, 2020.   The Eastern District of North Carolina Court denied BDSI’s motion to dismiss 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.  Our response to BDSI’s counterclaims is due May 7, 2020.

Antitrust Litigation

On September 22, 2016, forty-one states and the District of Columbia, or the States, brought suit against Indivior and us 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 we were not named as a defendant in the original Suboxone MDL cases, the action brought by the States alleges that we 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. We moved to dismiss the States’ conspiracy claims, but by order dated October 30, 2017, the Court denied our motion to dismiss. We filed an answer denying the States’ claims 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 beingwere conducted through August 1, 2019.  Summary judgement motions and Daubertmotions 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 witnesseswhich we are due on September 26, 2019.not a party. We are not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates,estimate, of the possible outcome or loss, if any, in this matter.

California Complaint

On December 5, 2019, Neurelis Inc. (“Neurelis”) filed a complaint against Aquestive in the Superior Court of California, County of San Diego alleging Unfair Competition, Defamation, and Malicious Prosecution related to the Company’s pursuit of FDA approval for Libervant™. Neurelis filed a First Amended Complaint on December 9, 2019, alleging the same three causes of action.  The Company filed a Motion to Strike Neurelis’s Complaint under California’s anti-SLAPP (“strategic lawsuit against public participation”) statute on January 31, 2020, which Neurelis is expected to oppose.  Neurelis filed a motion for leave to file a Supplemental Complaint on February 5, 2020, which we will oppose.  A hearing on our anti-SLAPP motion and Neurelis’s motion for leave was scheduled for April 24, 2020 but was postponed as a result of court closures in San Diego County, California resulting from the COVID-19 pandemic.  The parties are awaiting further action from the court regarding a new hearing date.  We are not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimate, of the possible outcome or loss, if any, in this matter.
Item 1A.
Risk Factors

OurIn light of recent developments relating to the COVID-19 global pandemic, the Company is supplementing the risk factors have not changed materially from those describedpreviously disclosed in “Part I, Item 1A. Risk Factors”1A of our 2018its Annual Report on Form 10-K exceptfor the year ended December 31, 2019, as set forthfiled with the Securities and Exchange Commission on March 11, 2020, to include the following risk factor under the heading “Risks Related to our Business Operations and Industry”:

Our business may be adversely affected by the ongoing coronavirus pandemic.

Beginning in late 2019, the outbreak of a novel strain of a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes coronavirus disease 2019, or COVID-19, has evolved into a global pandemic.  Depending upon the length and severity of the pandemic, which cannot be predicted, we may experience disruptions that could materiality and adversely impact our business including:

Various aspects of our clinical trials, including delays or difficulties in enrolling patients in our clinical trials, in clinical trial site initiation, and  in recruiting clinical site investigators and clinical site staff; increased rates of patients withdrawing from clinical trials; diversion of healthcare resources away from the conduct of clinical trials; interruption of key clinical trial activities such as clinical trials site data monitoring due to limitations on travel imposed or recommended by federal or state governments; impact on employees and others or interruption of clinical trial visits or study procedures which may impact the integrity of subject data and clinical study endpoints; and interruption or delays in the risk factor below.operations of the U.S. Food and Drug Administration, FDA, and comparable foreign regulatory agencies, which may impact regulatory review and approval timelines.

A substantial portion
If any third-party in our supply chain for any materials, including active pharmaceutical ingredients and other raw materials supply, which we need for our product candidates for our clinical trials and for the approved products we manufacture and distribute, are adversely impacted by restrictions resulting from the coronavirus pandemic, including staffing shortages, production slowdowns, or disruptions in freight and other transportation services and delivery distribution systems, our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials, conduct our research, development and clinical operations, and manufacture, distribute and sell our approved products.

We have closed our business office and requested most of our revenues is currently derivedcolleagues located there to work from relatively fewhome, restricted on-site staff generally to those colleagues who must perform essential activities on-site and limited the number of staff in our research and development laboratory.  Our increased reliance on colleagues and other third parties on whom we rely working from home or having health issues may negatively impact productivity and our commercialization activities for our existing approved products and commercial launch activities for any new approved product, or disrupt, delay, or otherwise adversely impact our business.  In addition, this could increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations.  Our colleagues conducting research and development activities may not be able to access our laboratory or manufacturing facilities for an extended period of time as a result of the closure of our facilities and the possibility of further governmental restrictions.  As a result, this could delay timely completion of pre-clinical activities, including completing Investigational New Drug (IND)/Clinical Trial Application (CTA) enabling studies or our ability to select future development candidates, and initiation of clinical or other of our development programs and production and delivery of our products.

The FDA and comparable foreign regulatory agencies may experience disruptions, have slower response times or be under-resourced to continue to monitor our clinical trials or to conduct required activities and review of our product candidates seeking regulatory review and such disruptions could materially affect the development, timing and approval of our product candidates.

The coronavirus pandemic may impact the requirements of our customers and licenseesgrowth of our approved products.  For example, Indivior, our significant customer for Suboxone, recently announced that it anticipated coronavirus impact on its product sales. We cannot predict the likely potential adverse impact of the coronavirus pandemic on the requirements for orders of our approved products Suboxone and any lossSympazan.  We also could experience extended customer payment cycles.

As a result of market volatility caused by continued effects of the coronavirus affecting the global economy, we may face difficulties raising capital through sales or material reduction in revenues from oneour common stock or more significant customersother securities.  In addition, a recession, depression or other sustained adverse market event could materially and adversely affect the financial markets, our business.business, the value of our common stock and our ability to obtain on favorable terms, or at all, equity or debt financing or the monetization of our royalty streams.

Historically, a substantial portion
The coronavirus pandemic continues to rapidly evolve.  The ultimate impact of our revenues in each quarterthe coronavirus pandemic on us is highly uncertain and year has been derived from relatively few customerssubject to change and licensees and this trend is expected to continue while we continue to develop, seek regulatory approvalswill depend on future developments, which cannot be accurately predicted.  We do not yet know the full extent of and seek to commercialize our proprietary products and product candidates. If revenues from a key customer were to decline significantly, it could materially adversely affectpotential delays or impacts on our business, financial condition and results of operations.

In April 2019our clinical trials, our research programs, the U.S. Department of Justice announced that a federal grand jury sitting in the Western District of Virginia had criminally indicted Indivior, for which we exclusively manufacture and supply Suboxone film products and license certain of our intellectual property, in connection with Indivior’s allegedly deceptive and misleadingmanufacturing, marketing, and distribution practices in its distribution and sale of Suboxone filmour approved products, dating back a number of years, and seeking a monetary judgement of not less than $3 billion. Indivior has denied the claims and statedhealthcare system or the global economy.  Given the uncertainties, the Company is unable to provide assurance that it intends to contest the allegations vigorously. Indivior accounted for approximately 89% of our revenues for 2018 and in the future will continue to account for a substantial part of our revenues. However, thereoperations can be no assurance thatmaintained as planned prior to the claims against Indivior could not materiallyCOVID-19 pandemic.

Please also refer to the complete Item 1A of the Company’s Annual Report on Form 10-K filed with the Securities and adversely affect IndiviorExchange Commission on March 11, 2020 for additional risks and uncertainties facing the Company, any of which if this were to occur, could impact our supplyrisks and licensing relationship with Indivioruncertainties may be further heightened by the coronavirus pandemic and the volume and timing of its purchases from us, which could have a material adverse effect on the Company’s business prospects, financial impact on our business,condition, results of operations, liquidity and operating results. On July 11, 2019, Reckitt Benckiser Group plc, the predecessor in interest of Indivior, reached agreements with the U.S. Department of Justice and the Federal Trade Commission (FTC) to resolve their investigation into the sales and marketing of Suboxone Film by its former prescription pharmaceuticals business, now Indivior, a business that was wholly demerged from Reckitt Benckiser in 2014.  Reckitt Benckiser will pay a total of up to $1.4 billion to fully resolve all federal investigations. As of this filing, Indivior has provided no indication that is has settled this matter with the DOJ.available capital resources.

Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds

None.

Use of Proceeds

On July 24, 2018, the SEC declared our Registration Statement on Form S-1 (Registration Nos. 333-225924 and 333-226326) for our IPO effective. There have been no material changes in the planned use of proceeds from our IPO as described in our final prospectus filed with the SEC on July 25, 2018, pursuant to Rule 424(b) of the Securities Act.

Item 3.
Defaults Upon Senior Securities

None.

Item 4.
Mine Safety Disclosures

Not applicable.

Item 5.
Other Information

None.

Item 6.
Exhibits

The exhibits listed below are filed or furnished as part of this report.

Number Description
   
 
Indenture DatedFirst Amendment to License Agreement, effective as of July 15, 2019, amongMarch 16,2020, by and between 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 AquestiveSunovion Pharmaceuticals Inc. (formerly, Cynapsus Therapeutics, Inc. on July 16, 2019).
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed by Aquestive Therapeutics, Inc. in July 16, 2019).
Form of Purchase Agreement (incorporated by reference to) (filed as Exhibit 10.1 to the Current Report on Form 8-K filed by Aquestive Therapeutics, Inc. in July 16, 2019).
Collateral Agreement dated as of July 15, 2019, among Aquestive Therapeutics, Inc., as Issuer, the Other Grantors for time to time party thereto, U.S. Bank National Association, as Trustee,10-K and U.S. Bank National Association, as Collateral Agent (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K of the Company filed on March 20, 2020 and incorporated by Aquestive Therapeutics, Inc. on July 16, 2019)reference herein).
 
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a), as amended, under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
 
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a), as amended, under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
 
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
 
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
101.INS
 
XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document.
101.SCH
 
XBRL Taxonomy Extension Schema Document
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
 
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase Document

*Portions of this exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K.  The omitted information is not material and would likely cause competitive harm to the registrant if publicly disclosed.

SIGNATURES

 Pursuant to the requirements of the Securities Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the County of Somerset, State of New Jersey.

 
Aquestive Therapeutics, Inc.
(REGISTRANT)
  
Date:
August 6, 2019May 5, 2020
/s/ Keith J. Kendall
 Keith J. Kendall
 President and Chief Executive Officer
 (Principal Executive Officer)
  
Date:
August 6, 2019May 5, 2020
/s/ John T. Maxwell
 John T. Maxwell
 Chief Financial Officer
 (Principal Financial Officer)


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