0001140361-20-024555 | 10-Q | XBRL Viewer | Aquestive Therapeutics INC

Print Document View Excel Document

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2020	Nov. 02, 2020
Cover [Abstract]
Entity Registrant Name	Aquestive Therapeutics, Inc.
Entity Central Index Key	0001398733
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Shell Company	false
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Common Stock, Shares Outstanding		33,619,796
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
Entity Address, State or Province	NJ

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 17,064	$ 49,326
Trade and other receivables, net	7,990	13,130
Inventories, net	3,242	2,859
Prepaid expenses and other current assets	3,388	2,999
Total current assets	31,684	68,314
Property and equipment, net	7,728	9,726
Right-of-use assets, net	3,609	0
Intangible assets, net and other assets	7,402	439
Total assets	50,423	78,479
Current liabilities:
Accounts payable and accrued expenses	15,237	17,749
Lease liabilities, current	664	0
Loans payable, current	1,750	0
Deferred revenue, current	722	806
Total current liabilities	18,373	18,555
Loans payable, net	60,346	60,338
Lease liabilities	3,047	0
Deferred revenue, net of current portion	3,694	4,348
Asset retirement obligations	1,482	1,360
Total liabilities	86,942	84,601
Contingencies (note 18)
Stockholders' deficit:
Common stock, $.001 par value. Authorized 250,000,000 shares; 33,619,796 and 33,562,885 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	34	34
Additional paid-in capital	129,336	124,318
Accumulated deficit	(165,889)	(130,474)
Total stockholders' deficit	(36,519)	(6,122)
Total liabilities and stockholders' deficit	$ 50,423	$ 78,479

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Stockholders' deficit:
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	250,000,000	250,000,000
Common stock, shares issued (in shares)	33,619,796	33,562,885
Common stock, shares outstanding (in shares)	33,619,796	33,562,885

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) [Abstract]
Revenues	$ 8,260	$ 12,418	$ 38,700	$ 36,190
Costs and expenses:
Manufacture and supply	2,978	4,643	10,176	13,569
Research and development	7,260	5,063	15,461	17,517
Selling, general and administrative	11,803	13,714	40,310	47,868
Total costs and expenses	22,041	23,420	65,947	78,954
Loss from operations	(13,781)	(11,002)	(27,247)	(42,764)
Other income/(expenses):
Interest expense	(2,778)	(2,652)	(8,296)	(6,515)
Interest income	8	138	128	565
Loss on extinguishment of debt	0	(4,896)	0	(4,896)
Net loss before income taxes	(16,551)	(18,412)	(35,415)	(53,610)
Income taxes	0	0	0	0
Net loss	(16,551)	(18,412)	(35,415)	(53,610)
Comprehensive loss	$ (16,551)	$ (18,412)	$ (35,415)	$ (53,610)
Net loss per share - basic and diluted (in dollars per share)	$ (0.49)	$ (0.74)	$ (1.05)	$ (2.15)
Weighted-average number of common shares outstanding - basic and diluted (in shares)	33,619,379	25,031,478	33,592,846	24,992,229

Condensed Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Total	Cumulative Effect, Period of Adoption, Adjustment [Member] Common Stock [Member]	Cumulative Effect, Period of Adoption, Adjustment [Member] Additional Paid-in Capital [Member]	Cumulative Effect, Period of Adoption, Adjustment [Member] Accumulated Deficit [Member]	Cumulative Effect, Period of Adoption, Adjustment [Member]
Balance at Dec. 31, 2018	$ 25	$ 71,431	$ (61,376)	$ 10,080	$ 0	$ 20	$ (2,852)	$ (2,832)
Balance (in shares) at Dec. 31, 2018	24,957,309
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation	$ 0	1,422	0	1,422
Share-based compensation (in shares)	17,830
Net loss	$ 0	0	(14,726)	(14,726)
Balance at Mar. 31, 2019	$ 25	72,873	(78,954)	(6,056)
Balance (in shares) at Mar. 31, 2019	24,975,139
Balance at Dec. 31, 2018	$ 25	71,431	(61,376)	10,080	$ 0	$ 20	$ (2,852)	$ (2,832)
Balance (in shares) at Dec. 31, 2018	24,957,309
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss				(53,610)
Balance at Sep. 30, 2019	$ 25	83,354	(117,838)	(34,459)
Balance (in shares) at Sep. 30, 2019	25,042,964
Balance at Mar. 31, 2019	$ 25	72,873	(78,954)	(6,056)
Balance (in shares) at Mar. 31, 2019	24,975,139
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares issued under employee stock purchase plan	$ 0	132	0	132
Shares issued under employee stock purchase plan (in shares)	31,393
Share-based compensation	$ 0	1,739	0	1,739
Share-based compensation (in shares)	16,128
Net loss	$ 0	0	(20,472)	(20,472)
Balance at Jun. 30, 2019	$ 25	74,744	(99,426)	(24,657)
Balance (in shares) at Jun. 30, 2019	25,022,660
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation	$ 0	1,810	0	1,810
Share-based compensation (in shares)	20,304
Fair value of warrants issued	$ 0	6,800	0	6,800
Net loss	0	0	(18,412)	(18,412)
Balance at Sep. 30, 2019	$ 25	83,354	(117,838)	(34,459)
Balance (in shares) at Sep. 30, 2019	25,042,964
Balance at Dec. 31, 2019	$ 34	124,318	(130,474)	(6,122)
Balance (in shares) at Dec. 31, 2019	33,562,885
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation	$ 0	1,823	0	1,823
Share-based compensation (in shares)	19,811
Net loss	$ 0	0	(16,530)	(16,530)
Balance at Mar. 31, 2020	$ 34	126,141	(147,004)	(20,829)
Balance (in shares) at Mar. 31, 2020	33,582,696
Balance at Dec. 31, 2019	$ 34	124,318	(130,474)	(6,122)
Balance (in shares) at Dec. 31, 2019	33,562,885
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss				(35,415)
Balance at Sep. 30, 2020	$ 34	129,336	(165,889)	(36,519)
Balance (in shares) at Sep. 30, 2020	33,619,796
Balance at Mar. 31, 2020	$ 34	126,141	(147,004)	(20,829)
Balance (in shares) at Mar. 31, 2020	33,582,696
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares issued under employee stock purchase plan	$ 0	73	0	73
Shares issued under employee stock purchase plan (in shares)	14,961
Share-based compensation	$ 0	1,702	0	1,702
Share-based compensation (in shares)	18,944
Net loss	$ 0	0	(2,334)	(2,334)
Balance at Jun. 30, 2020	$ 34	127,916	(149,338)	(21,388)
Balance (in shares) at Jun. 30, 2020	33,616,601
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation	$ 0	1,420	0	1,420
Share-based compensation (in shares)	3,195
Net loss	$ 0	0	(16,551)	(16,551)
Balance at Sep. 30, 2020	$ 34	$ 129,336	$ (165,889)	$ (36,519)
Balance (in shares) at Sep. 30, 2020	33,619,796

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 45
-Paragraph 1A
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121641772&loc=SL7669619-108580

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8924-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 11
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22694-107794

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-URI http://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 11
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22694-107794

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 205
-SubTopic 20
-Section 50
-Paragraph 7
-URI http://asc.fasb.org/extlink&oid=109222650&loc=SL51721683-107760

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 4
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22595-107794

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section 45
-Paragraph 1B
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121641772&loc=SL7669625-108580

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 11: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(18))
-URI http://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
-URI http://asc.fasb.org/extlink&oid=120395209&loc=SL114868664-224227

Reference 13: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 230
-SubTopic 10
-Section 45
-Paragraph 28
-URI http://asc.fasb.org/extlink&oid=121586364&loc=d3e3602-108585

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 1
-Subparagraph (b)(2)
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22499-107794

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 9
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22663-107794

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 825
-SubTopic 10
-Section 50
-Paragraph 28
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=75031198&loc=d3e14064-108612

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22583-107794

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 260
-SubTopic 10
-Section 45
-Paragraph 60B
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121326447&loc=SL5780133-109256

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 323
-SubTopic 10
-Section 50
-Paragraph 3
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=114001798&loc=d3e33918-111571

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=109234566&loc=d3e22658-107794

+ Details

- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

+ References + Details

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Cash flows used for operating activities:
Net loss	$ (35,415)	$ (53,610)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation and amortization	2,337	2,288
Share-based compensation	5,052	5,199
Amortization of debt issuance costs and discounts	1,758	1,338
Loss on extinguishment of debt	0	4,896
All other non-cash expenses	34	76
Changes in operating assets and liabilities:
Trade and other receivables	5,082	(3,887)
Inventories, net	(383)	1,317
Prepaid expenses and other assets	(7,101)	(1,029)
Accounts payable and accrued expenses	(2,573)	(5,632)
Deferred revenue	(738)	(591)
Net cash used for operating activities	(31,947)	(49,635)
Cash flows used for investing activities:
Capital expenditures	(281)	(577)
Net cash used for investing activities	(281)	(577)
Cash flows from financing activities:
Proceeds from shares issued under employee stock purchase plan	62	112
Proceeds from issuance of long-term debt	0	70,000
Debt repayment	0	(50,000)
Payments for loan acquisition costs	0	(3,918)
Premium paid to retire debt	0	(2,944)
Payments for taxes on share-based compensation	(96)	(2,723)
Net cash (used for)/provided by financing activities	(34)	10,527
Net decrease in cash and cash equivalents	(32,262)	(39,685)
Cash and cash equivalents:
Beginning of period	49,326	60,599
End of period	17,064	20,914
Supplemental disclosures of cash flow information:
Cash payments for interest	6,562	5,153
Net (decrease) in capital expenditures included in accounts payable and accrued expenses	(152)	(290)
Net increase in offering costs included in accounts payable and accrued expenses	237	162
Warrants issued in connection with long-term debt	$ 0	$ 6,800

Corporate Organization and Company Overview

9 Months Ended

Sep. 30, 2020

Corporate Organization and Company Overview [Abstract]

Corporate Organization and Company Overview

Note 1.

Corporate Organization and Company Overview

(A) Company Overview

Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) is a pharmaceutical company focused on identifying, developing and commercializing differentiated products that address patients’ unmet medical needs and solve therapeutic problems. The Company has commercialized one internally-developed proprietary product to date, has a commercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and other unmet needs, and is developing orally administered complex molecules as alternatives to more invasive therapies. Aquestive is pursuing its business objectives through both in-licensing and out-licensing arrangements, as well as the commercialization of its own products. Production facilities are in Portage, Indiana, and corporate headquarters, sales and commercialization operations and primary research laboratory facilities are based in Warren, New Jersey.

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

(B) Equity Transaction

Equity Offering of Common Stock

On December 17, 2019, Aquestive received net proceeds of $37,835 after deducting underwriting discounts of $2,415 for the sale of 8,050,000 shares of common stock, par value $0.001 per share of the Company (“common stock”) in a public offering. Professional fees and other costs of this offering totaled $540, in addition to the underwriting discounts.

Basis of Presentation

9 Months Ended

Sep. 30, 2020

Basis of Presentation [Abstract]

Basis of Presentation

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, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2020 (the “2019 Annual Report on Form 10-K”). As included herein, the condensed consolidated balance sheet as of December 31, 2019 is derived from the audited consolidated financial statements as of that date. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the results of interim periods have been included. The accompanying financial statements reflect certain reclassifications from previously issued financial statements to conform to the current presentation. The Company has evaluated subsequent events for disclosure through the date of issuance of the accompanying unaudited condensed financial statements.

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

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2020

Summary of Significant Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Note 3.

Summary of Significant Accounting Policies

(A) Principles of Consolidation and Significant Accounting Policies

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, drug development 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.

The Company’s significant accounting policies are described in the audited consolidated financial statements included in the 2019 Annual Report on Form 10-K. Subsequent to the date of those financial statements, there have been no significant changes to these policies other than those listed below.

(B) Use of Estimates

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

As an emerging growth company, the Company has elected to take advantage of the extended transition period afforded by the Jumpstart Our Business Startups Act for the implementation of new or revised accounting standards and, as a result, the Company will comply with new or revised accounting standards no later than the relevant dates on which adoption of such standards is required for emerging growth companies. The Company believes that the impact of recently issued accounting standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

Recently Adopted Accounting Pronouncements:

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

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

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, and subsequently issued a number of amendments to this update. The new standard, as amended in Accounting Standards Codification, or ASC 606, provides a single comprehensive model to be used in accounting for revenue arising from contracts with customers and supersedes previous revenue recognition guidance. The standard’s core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. The Company adopted this standard effective January 1, 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 on January 1, 2020 without material impact on its condensed consolidated financial position or results of operations.

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

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

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

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

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

In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This Accounting Standards Update was issued to address the complexity in accounting for certain financial instruments with characteristics of liabilities and equity. Among other provisions, the amendments in this ASU significantly change the guidance on the issuer’s accounting for convertible instruments and the guidance on the derivative scope exception for contracts in an entity’s own equity such that fewer conversion features will require separate recognition, and fewer freestanding instruments, like warrants, will require liability treatment. More specifically, the ASU reduces the number of models that may be used to account for convertible instruments from five to three, amends diluted EPS calculations for convertible instruments, modifies the requirements for a contract that may be settled in an entity’s own shares to be classified in equity and requires expanded disclosures intended to increase transparency. These amendments will be effective for the Company beginning January 1, 2024, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2020-06 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.

Risks and Uncertainties

9 Months Ended

Sep. 30, 2020

Risks and Uncertainties [Abstract]

Risks and Uncertainties

Note 4.

Risks and Uncertainties

The Company’s cash requirements for 2020 and beyond include expenses related to continuing development and clinical evaluation of its products, manufacture and supply costs, costs of regulatory filings, patent prosecution expenses and litigation expenses, expenses related to commercialization of its products, as well as costs to comply with the requirements of being a public company operating in a highly regulated industry. As of September 30, 2020, working capital totaled $13,311, which included $17,064 of cash and cash equivalents.

As of September 30, 2020, Aquestive has experienced a history of net losses and the Company’s accumulated deficits totaled $165,889 which have been partially funded by profits from manufacture and supply operations, licensing revenues and certain other services, with the balance of the related funding requirements met by the Company’s equity and debt offerings including its 12.5% Senior Secured Notes due 2025 (the “12.5% Notes”). In 2019, the Company raised funding totaling $52,226, consisting of net proceeds of $13,110 from the refinancing of its debt in July 2019, $37,295 from the public offering of 8,050,000 common shares in December 2019, and $1,821 from the exercise of warrants issued in connection with the debt refinancing.

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

Subject to and absent any material adverse effect of these and other possible COVID-19 effects, the Company expects that its anticipated revenues from licensed and proprietary products, cash on hand, expense management initiatives, monetization of certain revenue streams for its out-licensed apomorphine product (KYNMOBI™), and access to equity markets, including under its shelf registration statement would be adequate to meet expected operating, investing, and financing needs for the next twelve months. To the extent additional funds are necessary to meet operating needs as the Company continues to execute its business strategy, additional funding requirements would be obtained through modification of the existing debt facility to extend the potential availability of the first and second re-openers, and access to appropriate financial markets for debt or equity financings, or a combination of these potential sources of funds, although management can provide no assurance that any of these sources of funding, either individually or in combination, will be available on reasonable terms, if at all. In addition, the Company may be required to utilize available financial resources sooner than expected. Management has based its expectation on assumptions that could 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.

Revenues and Trade Receivables, Net

9 Months Ended

Sep. 30, 2020

Revenues and Trade Receivables, Net [Abstract]

Revenues and Trade Receivables, Net

Note 5.

Revenues and Trade Receivables, Net

Revenue from Contracts with Customers

The Company’s revenues are derived from four primary sources: manufactured products made to order for licensees, including Suboxone® and Zuplenz®, manufacture and sale of its self-developed, self-commercialized proprietary product, Sympazan® (clobazam), intellectual property licensing arrangements, and product development services provided under contracts with customers.

Revenue Recognition and Performance Obligations

Aquestive recognizes revenue pursuant to ASC 606, Revenue from Contracts with Customers, to reflect amounts expected to be collectible in exchange for the transfer of contractually promised goods or services to its customers, as discussed in additional detail in the Company’s 2019 Annual Report on Form 10-K. Accordingly, the value of contractually promised goods or services is assessed at contract inception to identify those that constitute distinct performance obligations. Contract revenues are allocated to those distinct performance obligations based on estimated standalone values or expected values, and these allocated revenues are recognized at the point in time, or over the period of time, that those distinct obligations are satisfied. The Company’s performance obligations consist primarily of transferring control of goods, services or intellectual property that are identified in the contracts, purchase orders or invoices. Variable or contingent revenues which may become due from customers, such as milestone payments due upon acceptance of a regulatory filing, regulatory approval, or sales-based milestone payments, are not recognized until contingencies are met, the customer’s obligation to meet its contractual payment commitments is fixed and collection of invoiced amounts is reasonably assured, thereby limiting any significant probability of a revenue reversal.

Revenues from the sale of products and services and from licensing arrangements and related payments are evidenced by a contract with the customer. For manufacturing and supply and proprietary product sales, invoices are generally issued upon the transfer of control. Co-development and research revenue is typically invoiced based on the contractual payment schedule, or upon completion of the service. Licensing revenue is generally invoiced at the inception of an agreement, with additional charges rendered as related contingencies, such as regulatory approvals or sales targets, are met. Invoices are typically payable 30 to 60 days after the invoice date, however some payment terms may reach 75 days depending on the customer. The Company performs a review of each specific customer’s creditworthiness and ability to pay prior to acceptance as a customer, as well as periodic prospective reviews.

Manufacture and supply revenue – this revenue is derived from products manufactured exclusively for specific customers according to their strictly-defined specifications, subject only to specified quality control inspections. Accordingly, at the point in time when quality control requirements are satisfied, revenue net of related discounts is recorded.

Proprietary product sales, net – this net revenue is recognized upon delivery and transfer of control of proprietary product to the Company’s customers, at which point the Company has no ongoing performance obligations and the customer has assumed all significant risks and rewards of ownership. These revenues are subject to payment discounts, wholesaler service fees, volume and prompt payment discounts, rebates and other chargebacks, which are estimated and recorded at the time the revenue is recognized. Once all related variable considerations are resolved and uncertainties as to collectible amounts are eliminated, estimates are adjusted to actual allowance amounts. Provisions for these estimated amounts are reviewed and adjusted on no less than a quarterly basis.

License and royalty revenues – the Company may realize revenue from functional or from symbolic licenses. For functional licenses that do not require further development or other ongoing activities by the Company, the customer is viewed as acquiring the right to use the license as, and when, transferred and revenues are generally recorded at a point in time, subject to contingencies or constraints, if any. For symbolic licenses providing substantial value only in conjunction with other performance obligations to be met by the Company, such as manufactured products or development services, revenues may be deferred when advance payment is received and recognized over the term of the license agreement. 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.

Co-development and research fees – this revenue is recognized as contractual services or performance obligations are performed. Invoicing for contractual services may occur in advance or arrears, may, or may not, coincide with completion of underlying performance obligations, and therefore may give rise to contract assets or contract liabilities when the value of services completed varies from amounts that may be invoiced to the customer.

Contract Assets

In limited situations, certain customer contractual payment terms provide for invoicing in arrears. Accordingly, some, or all performance obligations may be completely satisfied before the customer may be invoiced under such agreements. In these situations, billing occurs after revenue recognition, which results in a contract asset supported by the estimated value of the completed portion of the performance obligation. These contract assets are reflected as a component of other receivables within Trade and other receivables and as a component of intangible and other assets within the Condensed Consolidated Balance Sheet. As of September 30, 2020, and December 31, 2019, such current and non-current contract assets were $8,922 and $4,363, respectively, consisting primarily of minimum annual royalties due under a certain licensing agreement and completed but unshipped products manufactured to specific order by certain licensees.

Contract Liabilities

In other limited situations, certain customer contractual payment terms are structured to permit invoicing in advance of delivery of a good or service. In such instances, the customer’s cash payment may be received before satisfaction of some, or any, performance obligations that are specified. In these situations, billing occurs in advance of revenue recognition, which results in contract liabilities. These contract liabilities are reflected as deferred revenue within the Condensed Consolidated Balance Sheet. As remaining performance obligations are satisfied, an appropriate portion of the deferred revenue balance is credited to earnings. As of September 30, 2020, and December 31, 2019, such contract liabilities were $4,416 and $5,154, respectively.

The Company’s revenues were comprised of the following:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Manufacture and supply revenue	$	5,903	$	9,155	$	20,078	$	24,739
License and royalty revenue		328		1,356		13,682		6,402
Co-development and research fees		341		1,073		870		2,862
Proprietary product sales, net		1,688		834		4,070		2,187
Total revenues	$	8,260	$	12,418	$	38,700	$	36,190

Disaggregation of Revenue

The following table provides disaggregated net revenue by geographic area:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
United States	$	6,567	$	11,022	$	35,496	$	33,683
Ex-United States		1,693		1,396		3,204		2,507
Total revenues	$	8,260	$	12,418	$	38,700	$	36,190

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

Trade and other receivables, net consist of the following:

	September 30, 2020			December 31, 2019

Trade receivables	$	6,659		$	9,094
Contract and other receivables		1,872			4,363
Less: allowance for bad debts		(264	)		(124	)
Less: sales-related allowances		(277	)		(203	)
Trade and other receivables, net	$	7,990		$	13,130

The current portion of contract and other receivables totaled $1,872 and $4,363 as of September 30, 2020 and December 31, 2019, respectively. The current period balance is comprised primarily of $1,000 of minimum royalty revenue due from a licensee and the remaining balance represents reimbursable costs incurred on behalf of customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services. The December 31, 2019 balance represents reimbursable costs incurred on behalf of customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services. Sales-related allowances for both periods presented are estimated in relation to revenues recognized for sales of Sympazan.

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

	September 30, 2020		December 31, 2019

Allowance for doubtful accounts at beginning of year	$	124	$	58
Additions charged to bad debt expense		140		66
Write-downs charged against the allowance		—		—
Allowance for doubtful accounts at end of the period	$	264	$	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 support redemptions. 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 sales related allowances and accruals for the nine months ended September 30, 2020:

	Total Sales Related Allowances and Accruals

Balance at December 31, 2019	$	1,377
Provision		3,996
Payments / credits		(3,441	)
Balance at September 30, 2020	$	1,932

Total reductions of gross product sales from sales-related allowances and accruals were $3,996 for the nine months ended September 30, 2020. Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction of trade receivables and accruals for wholesaler service fees, co-pay support redemptions and rebates as current liabilities. The accrued balances relative to these provisions included in Trade and other receivables, net and Accounts payable and accrued expenses were $277 and $1,655, respectively, as of September 30, 2020 and $203 and $1,174, respectively, as of December 31, 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 December 31, 2019, Indivior, Inc. (“Indivior”) provided 86% of the total revenues for the period, and as of that date, the Company’s outstanding receivable balance from Indivior represented approximately 80% of gross receivables. For the nine months ended September 30, 2020, there were two customers exceeding the 10% threshold for revenue while there were three customers exceeding the 10% threshold for outstanding accounts receivable. Revenues provided by Indivior, and Sunovion Pharmaceuticals, Inc. (“Sunovion”) represented approximately 54% and 31%, respectively of total revenue for the nine months ended September 30, 2020, and outstanding accounts receivable due from Indivior, Sunovion and AmerisourceBergen represented approximately 50%, 12% and 11%, respectively of gross receivables.

Material Agreements

9 Months Ended

Sep. 30, 2020

Material Agreements [Abstract]

Material Agreements

Note 6.

Material Agreements

Commercial Exploitation Agreement with Indivior

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

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

The Indivior License Agreement provides for payment by Indivior of a purchase price per unit that is subject to adjustment based on the Company’s ability to satisfy minimum product thresholds. Additionally, in the event Indivior purchases certain large quantities of Suboxone during a specified period, Indivior will be entitled to scaled rebates on 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 each of the United States and in the rest of the world subject to annual maximum amounts and limited to the life of the related United States or international patents. In 2012, Indivior exercised its right to buy out its future royalty obligations in the United States under the Indivior License Agreement. Indivior remains obligated to pay royalties for all sales outside the United States.

The Indivior License Agreement contains customary contractual termination provisions, including with respect to a filing for bankruptcy or corporate dissolution, an invalidation of the intellectual property surrounding Suboxone, and commission of a material breach of the Indivior License Agreement by either party. Additionally, Indivior may terminate the Indivior License Agreement if the 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, the Company conveyed to Indivior all 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, the Company is entitled to receive certain payments from Indivior commencing on the date of the agreement through January 1, 2023. Once paid, all payments made under the Indivior Supplemental Agreement are non-refundable. Through February 20, 2019, the at-risk launch date of the competing generic products of Dr. Reddy’s Labs and Alvogen, the 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 were suspended until adjudication of related patent infringement litigation is finalized. If such litigation is successful, in addition to the amounts already received as described in the foregoing, the 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) an additional $1,250 that was earned through the issuance of additional process patent 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.

On April 1, 2016, the Company entered into a license agreement with Cynapsus Therapeutics Inc. (which was later succeeded to in interest by Sunovion Pharmaceuticals Inc.), referred to as the Sunovion License Agreement, pursuant to which Sunovion obtained an exclusive, worldwide license (with the right to sub-license) to certain intellectual property, including existing and future patents and patent applications, covering all oral films containing apomorphine for the treatment of off episodes in Parkinson’s disease patients. Sunovion used this intellectual property to develop its apomorphine product, KYNMOBI™, which was approved by the FDA on May 21, 2020. This approval triggered Sunovion’s obligation to remit a payment of $4,000 (the “FDA Approval Milestone Payment”) due on the earlier of: (a) the first day of product availability at a pharmacy in the United States; or (b) within six months of the FDA approval. This amount was received as of September 30, 2020 and is included in License and royalty revenues for the nine-months ended September 30, 2020.

In consideration for the rights granted to Sunovion under the Sunovion License Agreement, the Company received aggregate payments totaling $22,000 to date. In addition to the upfront payment of $5,000, the Company also earned an aggregate of $17,000 in connection with specified regulatory and development milestones in the United States and Europe (the “Initial Milestone Payments”) The Company is also entitled to receive certain contingent one-time milestone payments related to product availability and regulatory approval in Europe, certain one-time milestone payments based on the achievement of specific annual net sales thresholds of KYNMOBI™, and ongoing mid-single digit percentage royalty payments related to the net sales of KYNMOBI™ (subject to reduction to low-single digit percentage royalty payments in certain circumstances), subject to certain minimum payments. The maximum aggregate milestone payments that may be paid to the Company pursuant to the Sunovion License Agreement are equal to $45,000. There can be no guarantee that any future milestones will be met or that additional milestone payments will be payable. There are minimum annual guaranteed royalty payments under the contract. As of September 30, 2020, the Company recorded minimum royalty receivables of $8,000 in the aggregate, of which $1,000 is included in Trade and other receivables and $7,000 is included in Intangibles, net and other assets, with the total reflected in License and royalty revenues for the nine- months ended September 30, 2020.

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

On October 23, 2020, the Company amended the Sunovion License Agreement to clarify the parties’ agreement with respect to certain provisions in the License Agreement, specifically the date after which Sunovion has the right to terminate the License Agreement and the rights and obligations of the parties regarding the prosecution and maintenance of the Company’s patents covered under the License Agreement. See Note 19, (A), Subsequent Events. On November 3, 2020, the Company entered into a royalty monetization agreement (the “Monetization Agreement”) with an affiliate of Marathon Asset Management (“Marathon”) pursuant to which the Company conveyed to Marathon the right to all royalties and other payments due to the Company under the Sunovion License Agreement. See Note 19, (B), Subsequent Events.

Agreement to Terminate CLA with KemPharm

In March 2012, the Company entered into an agreement with KemPharm, Inc. (“KemPharm”) to terminate a Collaboration and License Agreement entered into by the Company and KemPharm in April 2011. Under this termination arrangement, the Company has the right to participate in any and all value that KemPharm may derive from the commercialization or any other monetization of KemPharm’s KP-415 and KP-484 compounds or their derivatives. Among these monetization transactions are those related to any business combinations involving KemPharm and collaborations, royalty arrangements, or other transactions from which KemPharm may realize value from these compounds. During September 2019, the Company received $1,000 from its 10% share of milestone payments paid to KemPharm under its licensing of KP-415 and KP-484 to a third party. The Company has also received a payment of $500 under this arrangement during June 2020, which is included in License and royalty revenues for the nine-month period ended September 30, 2020, in connection with the FDA’s acceptance of a New Drug Application (“NDA”) filing for KP-415. A Prescription Drug User Fee Act (PDUFA) target date for completion of FDA review has been scheduled for early March 2021. The Company’s share of remaining milestone payments associated with KP-415 approval and certain targeted labeling goals within timeframes ending in July 2021 may reach $4,800. However, there can be no guarantee that approvals, goals or any such payments will be achieved or received in the future.

Financial Instruments - Fair Value Measurements

9 Months Ended

Sep. 30, 2020

Financial Instruments - Fair Value Measurements [Abstract]

Financial Instruments - Fair Value Measurements

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. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

•

Level 1 — Observable quoted prices in active markets for identical assets or liabilities.

•

Level 2 — Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

•

Level 3 — Unobservable inputs that are supported by little or no market activity, such as pricing models, discounted cash flow methodologies and similar techniques.

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

The Company granted warrants to certain holders of the 12.5% Notes in connection with its debt refinancing in July 2019. These warrants were valued based primarily on Level 3 inputs and an independent third-party appraisal prepared 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 Compensation. See Note 14 for further information on these warrants.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Inventories, Net

9 Months Ended

Sep. 30, 2020

Inventories, Net [Abstract]

Inventories, Net

Note 8.

Inventories, Net

The components of Inventory, net is as follows:

	September 30, 2020		December 31, 2019

Raw material	$	1,153	$	1,244
Packaging material		1,231		1,096
Finished goods		858		519
Total inventory, net	$	3,242	$	2,859

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

Property and Equipment, Net

9 Months Ended

Sep. 30, 2020

Property and Equipment, Net [Abstract]

Property and Equipment, Net

Note 9.

Property and Equipment, Net

	Useful Lives	September 30, 2020			December 31, 2019

Machinery	3-15 yrs	$	21,406		$	21,088
Furniture and fixtures	3-15 yrs		1,209			1,150
Leasehold improvements	(a)		21,333			21,333
Computer, network equipment and software	3-7 yrs		2,886			2,787
Construction in progress			1,065			1,412
			47,899			47,770
Less: accumulated depreciation and amortization			(40,171	)		(38,044	)
Total property and equipment, net		$	7,728		$	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 $714 and $695 for the three-month periods ended September 30, 2020 and 2019, respectively. For the respective nine-month periods, these expenses totaled $2,127 and $2,143.

Right-of-Use Assets and Lease Obligations

9 Months Ended

Sep. 30, 2020

Right-of-Use Assets and Lease Obligations [Abstract]

Right-of-Use Assets and Lease Obligations

Note 10.

Right-of-Use Assets and Lease Obligations

The Company leases all realty used as its production and warehouse facilities, corporate headquarters, commercialization operations center and research and laboratory facilities. None of these three leases include the characteristics specified in ASC 842, Leases, that require classification as financing leases and, accordingly, these leases are accounted for as operating leases. These leases provide remaining terms between 2.5 years and 6.0 years, including renewal options expected to be exercised to extend the lease periods. Measurement of the operating lease liability reflects an estimated discount rate of 16.9% applied to minimum lease payments, including expected renewals, based on the incremental borrowing rate experienced in the Company’s latest collateralized debt refinancing. Right-of-use assets recorded upon adoption of ASC 842 totaled $4,048. For the three- and nine-month periods ended September 30, 2020, total operating lease expenses under these leases totaled $409 and $1,228, respectively, including variable lease expenses such as common area maintenance and operating costs totaling $89 and $255, respectively. Total payments to these lessors during the nine-month period ended September 30, 2020 were $1,255.

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

Remainder of 2020	$	266
2021		1,287
2022		1,295
2023		944
2024		565
2025		565
2026		424
Total lease payments		5,346
Less: imputed interest		(1,635	)
Total operating lease liabilities	$	3,711

Intangible Assets, Net and Other Assets

9 Months Ended

Sep. 30, 2020

Intangible Assets, Net and Other Assets [Abstract]

Intangible Assets, Net and Other Assets

Note 11.

Intangible Assets, Net and Other Assets

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

	September 30, 2020			December 31, 2019

Purchased technology-based intangible	$	2,358		$	2,358
Purchased patent		509			509
		2,867			2,867
Less: accumulated amortization		(2,752	)		(2,714	)
Intangible assets, net		115			153
Royalty receivable		7,000			-
Other assets, primarily security deposits		287			286
Total intangible assets, net and other assets	$	7,402		$	439

Amortization expense was $13 for each of the three-month periods ended September 30, 2020 and 2019. For the corresponding nine-month periods, these expenses totaled $38 and $39, respectively. During the remaining life of the purchased patent, estimated annual amortization expense is $50 for each of the years from 2020 to 2022. Royalty receivable consists of seven annual $1,000 minimum royalty payments due from Sunovion, the last of which is due in March 2028. See Note 6 above.

Accounts Payable and Accrued Expenses

9 Months Ended

Sep. 30, 2020

Accounts Payable and Accrued Expenses [Abstract]

Accounts Payable and Accrued Expenses

Note 12.

Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following:

	September 30, 2020		December 31, 2019

Accounts payable	$	9,169	$	12,274
Accrued compensation		4,129		3,758
Accrued distribution expenses		1,655		1,174
Other		284		543
Total accounts payable and accrued expenses	$	15,237	$	17,749

12.5% Senior Secured Notes and Loans Payable

9 Months Ended

Sep. 30, 2020

12.5% Senior Secured Notes and Loans Payable [Abstract]

12.5% Senior Secured Notes and Loans Payable

Note 13.

12.5 % Senior Secured Notes and Loans Payable

12.5% Senior Secured Notes

On July 15, 2019, the Company completed a private placement of up to $100 million aggregate principal of the 12.5% Notes and issued warrants for two million shares of common stock (the “Warrants”), $.001 par value per share, through the structuring agent, Morgan Stanley & Co., LLC, and entered into a purchase agreement and related agreements including a Collateral Agreement with U.S. Bank National Association, as trustee and collateral agent, and a Lien Subordination and Intercreditor Agreement for the benefit of Madryn Health Partners, other institutional noteholders (the “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 the 12.5% Notes (“Indenture”), the Company issued $70,000 of principal of the 12.5% 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 the 12.5% 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 (the “Additional Notes”) tied to the NDA filing for and FDA U.S. marketing approval of Libervant™, an important part of the Company’s drug candidate pipeline. Subject to approval of the holder of a majority of the outstanding principal amount of the 12.5% Notes in its discretion, and provided that no events of default exist, the Company may offer to the Lenders participation in a $10,000 additional offering of the 12.5% 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 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. On November 3, 2020, this Indenture was amended and will be partially repaid from proceeds resulting from the monetization transaction. See Note 19 (C), Subsequent Events. There can be no assurance that any additional financing will be consummated.

Proceeds from the 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 (the “Perceptive Loan”), related early repayment fees and legal and other fees incurred to obtain the loan.

The 12.5% 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. The Company has recorded $1,750 as Loans Payable, Current to reflect this obligation in its Condensed Consolidated Balance Sheet at September 30, 2020. Principal payments are scheduled to increase annually from 10% of the face amount of debt then outstanding during the first four quarters to 40% of the initial loan principal during the final four quarters.

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 12.5% Notes at any time at premiums that range from 101.56% of outstanding principal if prepayment occurs on or after the 5^th anniversary of the issue date of the Initial Notes to 112.5% if payment occurs during the third year after the issuance of the Initial Notes. In the event that redemption occurs within the two years after the issuance of the 12.5% 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 a change of control provision under which the Company may be required to repurchase the 12.5% Notes at 101% of the remaining principal plus accrued interest at the election of the Lenders.

Collateral for the loan under the 12.5% Notes consists of a 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 (“ABL Facility”) may be obtained, subject receivables and inventory assets will provide a second priority lien to senior secured Noteholders. The Company’s license of its intellectual property to a third-party drug development enterprise (specifically, Sunovion’s KYNMOBI™ product) is one of the various assets serving as collateral for the loan. The Indenture permits the Company to monetize this asset while specifying that a portion of the proceeds, up to $40,000 if the First Additional Offering has not been elected or funded, or, $50,000 if it has been elected and funded, must be applied to prepay the Initial Notes, at 112.5% of the principal amount of the 12.5% Notes being repurchased, plus accrued and unpaid interest, if any, thereon, to the date of the repurchase, to the extent elected by the Noteholders, 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 Noteholders. 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 Libervant™ by the FDA for U.S. marketing, at which time this cash collateral is to be released to the Company. Proceeds of more than $40,000 (or $50,000 if an additional tranche is issued) can be used immediately for general corporate purposes. As of September 30, 2020, the Company complied with all of its covenants under the Indenture.

The Company capitalizes legal and other third-party costs incurred in connection with obtaining debt as deferred debt issuance costs and applies the unamortized portion as a reduction of the outstanding face amount of the related loan in accordance with ASU 2015-03, Interest – Imputation of Interest: Simplifying the Presentation of Debt Issuance Costs. Similarly, the Company amortizes debt discounts, such as those represented by warrants issued to its holders, and offsets those as a direct reduction of its outstanding debt. Amortization expenses arising from deferred debt issuance costs and debt discounts related to the 12.5% Notes were $590 and $1,758 for the three- and nine-month periods ended September 30, 2020, respectively. Comparative amortization expenses derived from deferred debt issuance costs and debt discounts related to the Perceptive Loan and the 12.5% Notes for the three- and nine-month periods ended September 30, 2019 were $556 and $1,338, respectively. Unamortized deferred debt issuance costs and deferred debt discounts totaled $7,904 and $9,662 as of September 30, 2020 and December 31, 2019, respectively.

Loans Payable - Perceptive

In August 2016, the Company entered into a Loan Agreement and Guaranty with Perceptive Credit Opportunities Fund, LP (“Perceptive”) under which the total available facility of $50,000 had been borrowed as of March 2017. At closing, Perceptive received a warrant 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 Aquestive’s IPO. In July 2019, the Perceptive Loan was paid in full in connection with the completion of the sale of the Initial Notes and Warrants described above. The early extinguishment of this debt resulted in a charge to third quarter 2019 earnings of an amount of $4,896, including an early retirement premium of $2,944 and the remaining balances of the unamortized loan discount and loan acquisition costs.

Warrants Issued to 12.5% Senior Secured Noteholders

9 Months Ended

Sep. 30, 2020

Warrants Issued to 12.5% Senior Secured Noteholders [Abstract]

Warrants Issued to 12.5% Senior Secured Noteholders

Note 14.

Warrants Issued to 12.5% Senior Secured Noteholders

The Warrants that were issued in conjunction with the Initial Notes described above expire on June 30, 2025 and entitled the holders of the Initial 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 Initial Notes in the Company’s balance sheet. Additionally, since the Warrants issued do not provide warrant redemption or put rights within the control of the holders that could require the Company to make a payment of cash or other assets to satisfy the obligations under the Warrants, except in the case of a “cash change in control”, the fair value attributed to the Warrants is presented in Additional-paid in capital in the accompanying Condensed Consolidated Balance Sheets.

Certain holders of the Initial Notes exercised Warrants for the purchase of 428,571 shares of common stock and proceeds therefor totaling $1,821 were received on December 16, 2019. There were no Warrants exercised by the holders of the Initial Notes during the nine-month period ended September 30, 2020.

On November 3, 2020, the Indenture was amended, and additional at-the-money warrants will be issued at the time of purchase of additional Notes. See Note 19 (C), Subsequent Events.

Net Loss Per Share

9 Months Ended

Sep. 30, 2020

Net Loss Per Share [Abstract]

Net Loss Per Share

Note 15.

Net Loss Per Share

Basic net income or loss per share is calculated by dividing net income or loss by the weighted-average number of common shares outstanding during the periods. Diluted net income or loss per common share is similarly computed and includes the effect of any additional dilutive potential common shares outstanding during the periods. These potential common shares are excluded from the computation of net loss per share to the extent that their effects are antidilutive, and as a result of the Company’s net losses incurred for the three- and nine-month periods ended September 30, 2020 and 2019, respectively, no potentially dilutive securities have been included in the computation of diluted net loss per share for the periods presented below.

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Numerator:
Net loss	$	(16,551	)	$	(18,412	)	$	(35,415	)	$	(53,610	)
Denominator:
Weighted-average number of common shares – basic		33,619,379			25,031,478			33,592,846			24,992,229
Loss per common share – basic and diluted	$	(0.49	)	$	(0.74	)	$	(1.05	)	$	(2.15	)

The following outstanding stock options, restricted stock units and warrants are antidilutive and have been excluded from the computation of the loss per common share for the periods ended September 30:

	September 30, 2020		September 30, 2019
Options on common shares outstanding		3,075,942		2,256,092
Restricted stock units unvested		13,489		107,144
Warrants on common shares outstanding		1,571,429		—
Total potentially antidilutive derivatives excluded from losses per share		4,660,860		2,363,236

Share-Based Compensation

9 Months Ended

Sep. 30, 2020

Share-Based Compensation [Abstract]

Share-Based Compensation

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 as follows:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Manufacture and supply	$	73	$	60	$	208	$	176
Research and development		178		188		543		536
Selling, general and administrative		1,176		1,622		4,301		4,480
Total share-based compensation expenses	$	1,427	$	1,870	$	5,052	$	5,200

Share-based compensation from:
Restricted stock units	$	16	$	473	$	789	$	1,403
Stock options		1,411		1,397		4,252		3,777
Employee stock purchase plan		-		—		11		20
Total share-based compensation expenses	$	1,427	$	1,870	$	5,052	$	5,200

Share-Based Compensation Equity Awards

The following tables provide information about the Company’s restricted stock unit and stock option activity during the nine-month period ended September 30, 2020:

Restricted Stock Unit Awards (RSUs):	Number of Units			Weighted Average Grant Date Fair Value
	(in thousands)
Unvested as of December 31, 2019		74		$	14.64
Granted		4			7.54
Vested		(64	)		14.88
Forfeited		—			—
Unvested as of September 30, 2020		14		$	11.38
Grant date fair value of shares vested during the period	$	958
Unrecognized compensation costs as of September 30, 2020	$	140

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

Stock Option Awards:	Number of Options			Weighted Average Exercise Price
	(in thousands)
Outstanding as of December 31, 2019		2,231		$	10.42
Granted		981			2.68
Exercised, Forfeited, Expired		(136	)		(4.39	)

Outstanding as of September 30, 2020		3,076		$	8.22
Vested or expected to vest as of September 30, 2020		2,866		$	8.22
Exercisable as of September 30, 2020		1,014		$	11.87

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

Expected dividend yield	None
Expected volatility		100	%
Expected term (years)		5.5 - 6.1
Risk-free interest rate		0.4 – 1.7	%

The weighted average grant date fair value of stock options granted during 2020 was $2.10 During the nine-month period ended September 30, 2020, stock options were granted with exercise prices ranging from $1.54 to $7.86, and accordingly, given the Company’s share price of $4.86 at September 30, 2020, certain shares granted during this period provided intrinsic value at that date totaling $2,474. No intrinsic value was provided by stock options granted during the nine-month period ended September 30, 2019.

As of September 30, 2020, $6,554 of unrecognized compensation expense related to non-vested stock options is expected to be recognized over a weighted average period of 1.8 years from the date of grant.

Employee Stock Purchase Plan

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

Income Taxes

9 Months Ended

Sep. 30, 2020

Income Taxes [Abstract]

Income Taxes

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, no impact is expected.

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 September 30, 2020 and 2019, the Company recorded no income tax benefit from its pretax losses of $16,551 and $18,412, respectively, and similarly for the nine months ended September 30, 2020 and 2019, the Company recorded no tax benefit from its pretax loss of $35,415 and $53,610, 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 nine-month periods ended September 30, 2020 is the anticipated full year operating loss which will require full valuation allowances against any associated net deferred tax assets.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

Contingencies

9 Months Ended

Sep. 30, 2020

Contingencies [Abstract]

Contingencies

Note 18.

Contingencies

Litigation and Contingencies

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

Patent-Related Litigation

Beginning in August 2013, the Company was informed of abbreviated new drug application (“ANDA”) filings in the United States by Watson Laboratories, Inc. (now Actavis Laboratories, Inc., or “Actavis”), Par Pharmaceutical, Inc. (“Par”), Alvogen Pine Brook, Inc. (“Alvogen”), Teva Pharmaceuticals USA, Inc. (“Teva”), Sandoz Inc. (“Sandoz”), and Mylan Technologies Inc. (“Mylan”), for the approval by the FDA of generic versions of Suboxone Sublingual Film in the United States. Aquestive filed patent infringement lawsuits against all six generic companies in the United States District Court for the District of 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 products.

•

All cases against Par were resolved pursuant to a May 2018 settlement agreement among the Company, Indivior, and Par and certain of its affiliates.

•

Actavis was found to infringe Patent No. 8,603,514, or the ’514 patent, and cannot enter the market until the expiration of the patent in 2024, and the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) affirmed that ruling on July 12, 2019.

•

DRL and Alvogen were found not to infringe under a different claim construction analysis, and the Federal Circuit affirmed that ruling on July 12, 2019. Teva has agreed to be bound by all DRL adjudications.

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. A Markman hearing in the cases against Dr. Reddy’s and Alvogen which is pending in the United States District Court for the District of new Jersey (the “New Jersey District Court”) was held on October 17, 2019. On November 5, 2019, District Judge McNulty of the New Jersey District Court issued a Markman opinion construing the disputed terms of the asserted patents. On January 9, 2020, the New Jersey District Court entered a stipulated order of non-infringement of one of the patents, Patent No. 9,931,305, or the ’305 patent, based on the Federal Circuit’s claim construction ruling, and the Company and Indivior preserved available rights to appeal the claim construction ruling. On November 19, 2019, Magistrate Judge Waldor of the New Jersey District Court issued an order granting DRL and Alvogen’s requests to file amended answers to add antitrust counterclaims against Aquestive and Indivior. Aquestive and Indivior appealed the Magistrate Judge’s decision to District Judge McNulty on December 4, 2019, and DRL and Alvogen opposed the appeal. On January 17, 2020, the Company filed a motion to dismiss DRL’s and Alvogen’s antitrust counterclaims for failure to state a claim, and DRL and Alvogen opposed the motion. On August 24, 2020, Judge McNulty issued an Opinion and Order denying both the appeal of the Magistrate’s decision and Aquestive’s Motion to Dismiss. On June 3, 2020, the court issued an order setting a schedule for ongoing fact discovery, expert discovery, and dispositive motions. The schedule currently sets the close of fact discovery for October 20, 2020, with expert discovery continuing through the end of April 2021. The schedule also sets the deadline for filing dispositive motions for May 18, 2021. No trial date has been set in those cases. Management is not able to determine or predict the 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.

On February 19, 2019, the Federal Circuit issued its mandate reversing the New Jersey District Court’s preliminary injunction against Dr. Reddy’s. Following issuance of the mandate, the New Jersey District Court vacated preliminary injunctions against both Dr. Reddy’s and Alvogen. Dr. Reddy’s, Alvogen, and Mylan all launched generic versions of Suboxone Sublingual Film, and the launches by Dr. Reddy’s and Alvogen are “at risk” because the products are the subject of the ongoing patent infringement litigations.

On March 22, 2019, Aquestive 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 Company’s U. S. Patent Nos. 8,017,150, 9,687,454, the ’514 patent and ’305 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 Southern District of Florida Court entered an order dismissing the suit on December 18, 2019.

The Company is also seeking to enforce its patent rights in multiple cases against BioDelivery Sciences International, Inc. (“BDSI”). Three cases are currently pending but stayed in the U.S. District Court for the Eastern District of North 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, 8,652,378 and 8,475,832. This case is stayed.

•

The second was filed by Aquestive and Indivior related to BDSI’s infringing Bunavail product, and alleges infringement of Aquestive’s patent, U.S. Patent No. 8,765,167, or the ’167 patent, and seeks an injunction and potential monetary damages. Shortly after the case was filed, BDSI filed four (4) IPR’s challenging the asserted ’167 patent. On March 24, 2016, the United States Patent Trial and Appeal Board (“PTAB”), issued a final written decision finding that all claims of the ’167 patent were valid. The case was stayed in May 2016 pending the final determination of the appeals on those decisions. Following the PTAB’s February 7, 2019 decisions on remand denying institution, Aquestive and Indivior submitted a notice to the Court on February 15, 2019 notifying the Court that the stay should be lifted as a result of the PTAB’s decisions. The parties in this matter are awaiting further action from the Court.

•

On January 13, 2017, the Company also sued BDSI asserting infringement of the ’167 patent by BDSI’s Belbuca product and seeking an injunction and potential monetary damages. On August 7, 2019, the Eastern District of North Carolina Court granted BDSI’s motion to dismiss the Complaint without prejudice and denied BDSI’s motion to stay as moot. On November 11, 2019, Aquestive filed a new Complaint against BDSI in the Eastern District of North Carolina Court. On November 27, 2019, BDSI filed a motion to stay the case pending BDSI’s appeal of the PTAB’s remand decisions, and the Company opposed this motion. The Eastern District of North Carolina Court denied BDSI’s motion to stay on April 1, 2020. BDSI’s appeal of the PTAB’s remand decisions to the United States Court of Appeals for the Federal Circuit was docketed on March 13, 2019, and on March 20, 2019, and a motion was made to dismiss this appeal for lack of jurisdiction. On August 29, 2019, the Federal Circuit granted the motion to dismiss BDSI’s appeal. On September 30, 2019, BDSI filed a petition for rehearing in the Federal Circuit en banc, which the Company opposed. The Federal Circuit denied BDSI’s petition for rehearing en banc on January 13, 2020. On June 11, 2020, BDSI filed a petition for writ of certiorari at the Supreme Court of the United States. At the request of the Supreme Court, Aquestive filed an opposition to BDSI’s petition on August 17, 2020, and BDSI filed a reply on August 27, 2010. On October 5, 2020, the Supreme Court issued an order denying BDSI’s petition. After the Federal Circuit denied BDSI’s petition, on January 13, 2020, BDSI filed with the Eastern District of North Carolina Court a motion to dismiss the Complaint, and Aquestive opposed on February 2, 2020. The Eastern District of North Carolina Court denied BDSI’s motion to dismiss and its motion to stay on April 1, 2020. On April 16, 2020, BDSI filed an Answer to the Complaint, including counterclaims for non-infringement, invalidity, and unenforceability of the ’167 patent. On May 7, 2020, Aquestive filed a motion to dismiss BDSI’s unenforceability counterclaim and a motion to strike BDSI’s corresponding affirmative defenses for failure to state a claim for inequitable conduct under the heightened pleading standard applicable to such claims and defenses. Rather than oppose Aquestive’s Motion to Dismiss, on May 28, 2020, BDSI amended its counterclaims and filed an Answer and Amended Counterclaims, which included additional allegations in support of BDSI’s unenforceability counterclaim. On June 25, 2020, Aquestive filed a Motion to Dismiss BDSI’s Amended Counterclaim for unenforceability and a Motion to Strike BDSI’s corresponding affirmative defense of unenforceability again for failure to state a claim under the applicable heightened pleading standard. BDSI’s filed its opposition to Aquestive’s Motion to Dismiss and Strike on July 16, 2020. Aquestive filed its Reply to BDSI’s Opposition on July 30, 2020. The parties are awaiting further action from the court on Aquestive’s motion.

Antitrust Litigation

On September 22, 2016, forty-one states and the District of Columbia, or the States, brought suit against Indivior and the Company in the U.S. District Court for the Eastern District of Pennsylvania, alleging violations of federal and state antitrust statutes and state unfair trade and consumer protection laws relating to Indivior’s launch of Suboxone Sublingual Film in 2010 and seeking an injunction, civil penalties, and disgorgement. After filing the suit, the case was consolidated for pre-trial purposes with the In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation, MDL No. 2445, or the Suboxone MDL, a multidistrict litigation relating to putative class actions on behalf of various private plaintiffs against Indivior relating to its launch of Suboxone Sublingual Film. While Aquestive was not named as a defendant in the original Suboxone MDL cases, the action brought by the States alleges that the Company participated in an antitrust conspiracy with Indivior in connection with Indivior’s launch of Suboxone Sublingual Film and engaged in related conduct in violation of federal and state antitrust law. Aquestive moved to dismiss the States’ conspiracy claims, but by order dated October 30, 2017, the Court denied the motion to dismiss. An answer was filed denying the States’ claims on November 20, 2017. The fact discovery period closed 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 were conducted through August 1, 2019. 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 which the Company is not a party. On July 28, 2020, the U.S. Court of Appeals for the Third Circuit issued its opinion affirming the District Court’s order certifying the class. On August 27, 2020, the district court issued a scheduling order, setting the deadline for filing remaining Daubert challenges and summary judgment. Under the scheduling order, the remaining Daubert motions were filed on September 28, 2020, and oppositions are due on October 19, 2020. The court will set oral argument on the motions, but the date for oral argument is not yet known. Summary judgment motions are due January 11, 2021, and responses to summary judgment motions are due February 11, 2021. No trial date has yet been set. Management is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates, of the possible outcome or loss, if any, in this matter.

Humana and Centene Actions

On September 18, 2020, Humana, Inc., a health insurance payer, filed a suit against Aquestive and Indivior in the Eastern District of Pennsylvania relating to Suboxone. The Humana action, which alleges facts similar to those at issue in the Antitrust Case and the Suboxone MDL described above, was assigned to the same judge that is presiding over those actions. Humana’s Complaint alleges five causes of action against Aquestive, including conspiracy to violate the RICO Act, fraud under state law, unfair and deceptive trade practices under state law, insurance fraud, and unjust enrichment. On September 21, 2020, Centene Corporation and other related insurance payers filed a similar suit against Aquestive and Indivior in the Eastern District of Missouri. The counsel representing Humana is also representing Centene. On September 21, 2020, the Centene action was provisionally transferred to the Eastern District of Pennsylvania by the United States Judicial Panel on Multidistrict Litigation. No other proceedings have occurred and the schedule is not yet known. Management is 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.

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 will be opposed. On February 5, 2020, Neurelis filed a Motion for Leave to File a Supplemental Complaint (“Motion”). On June 5, 2020, Neurelis filed a Motion for Limited Discovery related to Aquestive’s anti-SLAPP motion.

The court previously scheduled a hearing on both Aquestive’s anti-SLAPP Motion and on Neurelis’s Motion for April 24, 2020. However, on April 3, 2020, in response to the COVID-19 pandemic, the court issued an order continuing all hearings scheduled through April 30, 2020. The court ultimately held a telephonic status conference on June 25, 2020 to determine a schedule for hearing the pending motions. During that status conference, the court set Aquestive’s anti-SLAPP motion for hearing on July 24, 2020. The court also declined Neurelis’s request to hear its Motion and its Motion for Limited Discovery. Neurelis filed its response to Aquestive’s anti-SLAPP Motion on July 13, 2020, and we filed our reply on July 17, 2020. The court held a telephonic hearing on Aquestive’s anti-SLAPP motion on July 24, 2020. On August 6, 2020, the Court issued an order granting in part and denying in part Aquestive’s anti-SLAPP motion. Aquestive filed a notice of appeal to the California Court of Appeal on September 1, 2020, and Neurelis filed a notice of cross-appeal on October 5, 2020. Management is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimates, of the possible outcome or loss, if any, in this matter.

Subsequent Events

9 Months Ended

Sep. 30, 2020

Subsequent Events [Abstract]

Subsequent Events

Note 19.

Subsequent Events

(A) Amendment to License Agreement with Sunovion Pharmaceuticals Inc.

Effective as of October 23, 2020, the Company entered into a Second Amendment to the Sunovion License Agreement whereby the parties to the Sunovion License Agreement agreed to clarify the continued rights and obligations of the parties with respect to the prosecution and maintenance of the Company’s patents covered under the Agreement and that, on and after March 31, 2028, in respect of any jurisdiction or jurisdictions covered under the License Agreement, Sunovion may terminate its rights with respect to the Licensed Patents under the License Agreement upon 180 days prior written notice to the Company.

(B) Monetization of Certain Rights under the Sunovion License Agreement

On November 3, 2020, the Company entered into the Monetization Agreement that will result in proceeds to the Company of up to $125,000 in exchange for which the Company conveyed to Marathon the right to all royalties and other payments due to the Company under the Sunovion License Agreement (See Note 6). Under the terms of the Monetization Agreement, Aquestive will receive a $40,000 cash payment within 12 business days of signing and is eligible to receive up to $85,000 of contingent payments at various points, beginning as early as the fourth quarter of 2020, based on the achievement of worldwide royalty targets and certain other commercial milestones.

With the proceeds paid to the Company at closing under the Monetization Agreement, the Company will repay $22,500 of the 12.5% Notes, and issue $4,000 of new senior notes in lieu of paying a prepayment premium on the early repayment of the 12.5% Notes, reducing the balance of senior notes outstanding to $51,500 in the aggregate. In addition, the holders of the 12.5% Notes have extended to December 31, 2021 the Company’s ability to access, at the Company’s option, $30,000 of senior notes re-openers under the Indenture. The first $10,000 senior notes re-opener represents a commitment of such amount by current holders of 12.5% Notes, at the option of the Company, contingent upon FDA approval of the Company’s product candidate Libervant (diazepam) Buccal Film for the management of seizure clusters. A second $20,000 senior notes re-opener represents a right, at the Company’s option, to market to current holders of the Company’s 12.5% Notes, and/or other lenders, additional senior notes up to such amount, contingent upon FDA approval of Libervant for U.S. market access. If and to the extent that the Company accesses these re-openers, the Company will grant warrants to purchase up to 714,000 shares of common stock, with the strike price calculated based on the 30-day volume weighted average closing price of the Company’s common stock at the warrant grant date. In addition, as of the closing of this transaction, the Company will issue to the holders of the 12.5% Notes warrants to purchase 143,000 shares of the Company’s common stock.

Basis of Presentation (Policies)	9 Months Ended
Basis of Presentation (Policies)	Sep. 30, 2020
Basis of Presentation [Abstract]
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, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2020 (the “2019 Annual Report on Form 10-K”). As included herein, the condensed consolidated balance sheet as of December 31, 2019 is derived from the audited consolidated financial statements as of that date. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the results of interim periods have been included. The accompanying financial statements reflect certain reclassifications from previously issued financial statements to conform to the current presentation. The Company has evaluated subsequent events for disclosure through the date of issuance of the accompanying unaudited condensed financial statements. Any reference in these notes to applicable guidance refers to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2020
Summary of Significant Accounting Policies [Abstract]
Principles of Consolidation and Significant Accounting Policies	(A) Principles of Consolidation and Significant Accounting Policies 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, drug development 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. The Company’s significant accounting policies are described in the audited consolidated financial statements included in the 2019 Annual Report on Form 10-K. Subsequent to the date of those financial statements, there have been no significant changes to these policies other than those listed below.
Use of Estimates	(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.
Recent Accounting Pronouncements	(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 accounting standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Recently Adopted Accounting Pronouncements: In February 2016, the Financial Accounting Standards Board issued ASU, 2016-02, Leases (Topic 842), and issued amendments in July 2018 provided by ASU 2018-10. This ASU, as amended, requires lessees to recognize lease assets, termed “right-of-use assets” and related lease liabilities on the balance sheet that had previously been classified as operating leases under prior authoritative guidance. For income statement purposes, leases are now required to be classified as either operating or financing leases under a dual model similar to that specified by ASC 840. Operating leases continue to result in straight-line expense while financing leases result in a front-loaded expense pattern in a manner similar to recognition of capital lease expenses under ASC 840. The Company adopted and applied ASU 2016-02 on January 1, 2020 using the modified retrospective transition provisions of ASC 842 to leases in effect as of that date of adoption and recorded right-of-use assets totaling $4,048 and lease liabilities as adjusted for accrued lease payments, in the amount of $4,224 based on an estimated incremental borrowing rate of 16.9%, representing the present value of remaining minimum lease payments. The assets and liabilities thus recorded were primarily those related to the Company’s leased plant, laboratory and corporate administrative facilities. The Company elected to apply the ASU-specified practical expedients and accordingly did not re-assess (i) whether its contracts contained a lease under the new definition of a lease, (ii) the classification of those leases, and (iii) initial direct costs of existing leases. In addition, the Company elected not to apply the hindsight expedient in the assessment of lease renewals and resultant term of leases. The Company also elected not to recognize a right-of-use asset and lease liability for those leases with a remaining lease term of 12 months or less. The adoption of ASU 2016-02 did not require a cumulative-effect adjustment to the opening balance of the accumulated deficit at the time of adoption. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, and subsequently issued a number of amendments to this update. The new standard, as amended in Accounting Standards Codification, or ASC 606, provides a single comprehensive model to be used in accounting for revenue arising from contracts with customers and supersedes previous revenue recognition guidance. The standard’s core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. The Company adopted this standard effective January 1, 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 on January 1, 2020 without material impact on its condensed consolidated financial position or results of operations. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework. The purpose of the update is to improve the effectiveness of the fair value measurement disclosures that allows for clear communication of information that is most important to the users of financial statements. There were certain required disclosures that have been removed or modified. In addition, the update added the following disclosures: (i) changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and (ii) the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The Company adopted this new guidance on January 1, 2020 without material impact on its condensed consolidated financial position or results of operations. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 when the collaborative arrangement participant is a customer for a promised good or service that is distinct within the collaborative arrangement. The guidance also precludes entities from presenting amounts related to transactions with a collaborative arrangement participant that is not a customer as revenue, unless those transactions are directly related to third-party sales. The Company adopted this new guidance on January 1, 2020 without material impact on its condensed consolidated financial position or results of operations. Recent Accounting Pronouncements Not Adopted as of September 30, 2020: In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326), amending existing guidance on the accounting for credit losses on financial instruments within its scope. The guidance provides for use of a forward-looking expected loss model for estimating credit losses, replacing the incurred loss model that is based on past events and current conditions. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for the Company beginning after December 15, 2022. The Company is currently evaluating the impact of the adoption of this guidance on its condensed consolidated financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other Internal-Use Software (Subtopic 350-40: Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The update provides guidance distinguishing between capitalizable service contract implementation costs and contract costs required to be expensed. In addition, the update requires that the term of the hosting arrangement is to include the non-cancelable period of the arrangement plus periods covered by (i) an option to extend the arrangement if the customer is reasonably certain to exercise that option; (ii) an option to terminate the arrangement if the customer is reasonably certain not to exercise the termination option and (iii) an option to extend (or not to terminate) the arrangement in which exercise of the option is in the control of the vendor. This standard will become effective for the Company beginning January 1, 2021. The amendments may be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company is currently evaluating the impact of ASU 2018-15 and does not expect to have a material impact on its 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. In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This Accounting Standards Update was issued to address the complexity in accounting for certain financial instruments with characteristics of liabilities and equity. Among other provisions, the amendments in this ASU significantly change the guidance on the issuer’s accounting for convertible instruments and the guidance on the derivative scope exception for contracts in an entity’s own equity such that fewer conversion features will require separate recognition, and fewer freestanding instruments, like warrants, will require liability treatment. More specifically, the ASU reduces the number of models that may be used to account for convertible instruments from five to three, amends diluted EPS calculations for convertible instruments, modifies the requirements for a contract that may be settled in an entity’s own shares to be classified in equity and requires expanded disclosures intended to increase transparency. These amendments will be effective for the Company beginning January 1, 2024, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2020-06 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.

Revenues and Trade Receivables, Net (Policies)	9 Months Ended
Revenues and Trade Receivables, Net (Policies)	Sep. 30, 2020
Revenues and Trade Receivables, Net [Abstract]
Revenue Recognition and Performance Obligations	Aquestive recognizes revenue pursuant to ASC 606, Revenue from Contracts with Customers, to reflect amounts expected to be collectible in exchange for the transfer of contractually promised goods or services to its customers, as discussed in additional detail in the Company’s 2019 Annual Report on Form 10-K. Accordingly, the value of contractually promised goods or services is assessed at contract inception to identify those that constitute distinct performance obligations. Contract revenues are allocated to those distinct performance obligations based on estimated standalone values or expected values, and these allocated revenues are recognized at the point in time, or over the period of time, that those distinct obligations are satisfied. The Company’s performance obligations consist primarily of transferring control of goods, services or intellectual property that are identified in the contracts, purchase orders or invoices. Variable or contingent revenues which may become due from customers, such as milestone payments due upon acceptance of a regulatory filing, regulatory approval, or sales-based milestone payments, are not recognized until contingencies are met, the customer’s obligation to meet its contractual payment commitments is fixed and collection of invoiced amounts is reasonably assured, thereby limiting any significant probability of a revenue reversal. Revenues from the sale of products and services and from licensing arrangements and related payments are evidenced by a contract with the customer. For manufacturing and supply and proprietary product sales, invoices are generally issued upon the transfer of control. Co-development and research revenue is typically invoiced based on the contractual payment schedule, or upon completion of the service. Licensing revenue is generally invoiced at the inception of an agreement, with additional charges rendered as related contingencies, such as regulatory approvals or sales targets, are met. Invoices are typically payable 30 to 60 days after the invoice date, however some payment terms may reach 75 days depending on the customer. The Company performs a review of each specific customer’s creditworthiness and ability to pay prior to acceptance as a customer, as well as periodic prospective reviews.

- Definition

Disclosure of accounting policy for revenue from contract with customer.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 17
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130561-203045

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130566-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130563-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130566-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130563-203045

Reference 7: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=84158767&loc=d3e18823-107790

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130566-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 19
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130564-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130566-203045

+ Details

Revenues and Trade Receivables, Net (Tables)

9 Months Ended

Sep. 30, 2020

Revenues and Trade Receivables, Net [Abstract]

Revenue

The Company’s revenues were comprised of the following:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Manufacture and supply revenue	$	5,903	$	9,155	$	20,078	$	24,739
License and royalty revenue		328		1,356		13,682		6,402
Co-development and research fees		341		1,073		870		2,862
Proprietary product sales, net		1,688		834		4,070		2,187
Total revenues	$	8,260	$	12,418	$	38,700	$	36,190

Disaggregation of Revenue

The following table provides disaggregated net revenue by geographic area:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
United States	$	6,567	$	11,022	$	35,496	$	33,683
Ex-United States		1,693		1,396		3,204		2,507
Total revenues	$	8,260	$	12,418	$	38,700	$	36,190

Trade and Other Receivables, Net

Trade and other receivables, net consist of the following:

	September 30, 2020			December 31, 2019

Trade receivables	$	6,659		$	9,094
Contract and other receivables		1,872			4,363
Less: allowance for bad debts		(264	)		(124	)
Less: sales-related allowances		(277	)		(203	)
Trade and other receivables, net	$	7,990		$	13,130

Changes in Allowance for Bad Debt

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

	September 30, 2020		December 31, 2019

Allowance for doubtful accounts at beginning of year	$	124	$	58
Additions charged to bad debt expense		140		66
Write-downs charged against the allowance		—		—
Allowance for doubtful accounts at end of the period	$	264	$	124

Sales Related Allowances and Accruals

The following table provides a summary of activity with respect to sales related allowances and accruals for the nine months ended September 30, 2020:

	Total Sales Related Allowances and Accruals

Balance at December 31, 2019	$	1,377
Provision		3,996
Payments / credits		(3,441	)
Balance at September 30, 2020	$	1,932

Inventories, Net (Tables)

9 Months Ended

Sep. 30, 2020

Inventories, Net [Abstract]

Inventory, Net

The components of Inventory, net is as follows:

	September 30, 2020		December 31, 2019

Raw material	$	1,153	$	1,244
Packaging material		1,231		1,096
Finished goods		858		519
Total inventory, net	$	3,242	$	2,859

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2020

Property and Equipment, Net [Abstract]

Property and Equipment, Net

	Useful Lives	September 30, 2020			December 31, 2019

Machinery	3-15 yrs	$	21,406		$	21,088
Furniture and fixtures	3-15 yrs		1,209			1,150
Leasehold improvements	(a)		21,333			21,333
Computer, network equipment and software	3-7 yrs		2,886			2,787
Construction in progress			1,065			1,412
			47,899			47,770
Less: accumulated depreciation and amortization			(40,171	)		(38,044	)
Total property and equipment, net		$	7,728		$	9,726

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

Right-of-Use Assets and Lease Obligations (Tables)

9 Months Ended

Sep. 30, 2020

Right-of-Use Assets and Lease Obligations [Abstract]

Operating Lease Liabilities

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

Remainder of 2020	$	266
2021		1,287
2022		1,295
2023		944
2024		565
2025		565
2026		424
Total lease payments		5,346
Less: imputed interest		(1,635	)
Total operating lease liabilities	$	3,711

Intangible Assets, Net and Other Assets (Tables)

9 Months Ended

Sep. 30, 2020

Intangible Assets, Net and Other Assets [Abstract]

Components of Identifiable Intangible Assets

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

	September 30, 2020			December 31, 2019

Purchased technology-based intangible	$	2,358		$	2,358
Purchased patent		509			509
		2,867			2,867
Less: accumulated amortization		(2,752	)		(2,714	)
Intangible assets, net		115			153
Royalty receivable		7,000			-
Other assets, primarily security deposits		287			286
Total intangible assets, net and other assets	$	7,402		$	439

Accounts Payable and Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2020

Accounts Payable and Accrued Expenses [Abstract]

Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following:

	September 30, 2020		December 31, 2019

Accounts payable	$	9,169	$	12,274
Accrued compensation		4,129		3,758
Accrued distribution expenses		1,655		1,174
Other		284		543
Total accounts payable and accrued expenses	$	15,237	$	17,749

12.5% Senior Secured Notes and Loans Payable (Tables)

9 Months Ended

Sep. 30, 2020

12.5% Senior Secured Notes and Loans Payable [Abstract]

Debt Maturity

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

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2020

Net Loss Per Share [Abstract]

Basic and Diluted Net Loss Per Share

These potential common shares are excluded from the computation of net loss per share to the extent that their effects are antidilutive, and

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Numerator:
Net loss	$	(16,551	)	$	(18,412	)	$	(35,415	)	$	(53,610	)
Denominator:
Weighted-average number of common shares – basic		33,619,379			25,031,478			33,592,846			24,992,229
Loss per common share – basic and diluted	$	(0.49	)	$	(0.74	)	$	(1.05	)	$	(2.15	)

Antidilutive Securities Excluded from Computation of Loss Per Common Share

	September 30, 2020		September 30, 2019
Options on common shares outstanding		3,075,942		2,256,092
Restricted stock units unvested		13,489		107,144
Warrants on common shares outstanding		1,571,429		—
Total potentially antidilutive derivatives excluded from losses per share		4,660,860		2,363,236

Share-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2020

Share-Based Compensation [Abstract]

Share-based Compensation Expense

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

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Manufacture and supply	$	73	$	60	$	208	$	176
Research and development		178		188		543		536
Selling, general and administrative		1,176		1,622		4,301		4,480
Total share-based compensation expenses	$	1,427	$	1,870	$	5,052	$	5,200

Share-based compensation from:
Restricted stock units	$	16	$	473	$	789	$	1,403
Stock options		1,411		1,397		4,252		3,777
Employee stock purchase plan		-		—		11		20
Total share-based compensation expenses	$	1,427	$	1,870	$	5,052	$	5,200

Restricted Stock Units Awards

The following tables provide information about the Company’s restricted stock unit and stock option activity during the nine-month period ended September 30, 2020:

Restricted Stock Unit Awards (RSUs):	Number of Units			Weighted Average Grant Date Fair Value
	(in thousands)
Unvested as of December 31, 2019		74		$	14.64
Granted		4			7.54
Vested		(64	)		14.88
Forfeited		—			—
Unvested as of September 30, 2020		14		$	11.38
Grant date fair value of shares vested during the period	$	958
Unrecognized compensation costs as of September 30, 2020	$	140

Stock Option Activity

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

Stock Option Awards:	Number of Options			Weighted Average Exercise Price
	(in thousands)
Outstanding as of December 31, 2019		2,231		$	10.42
Granted		981			2.68
Exercised, Forfeited, Expired		(136	)		(4.39	)

Outstanding as of September 30, 2020		3,076		$	8.22
Vested or expected to vest as of September 30, 2020		2,866		$	8.22
Exercisable as of September 30, 2020		1,014		$	11.87

Valuation Assumptions for Determination of Fair Value of Options

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

Expected dividend yield	None
Expected volatility		100	%
Expected term (years)		5.5 - 6.1
Risk-free interest rate		0.4 – 1.7	%

Corporate Organization and Company Overview (Details) $ / shares in Units, $ in Thousands		1 Months Ended
	Dec. 17, 2019 USD ($) $ / shares shares	Dec. 31, 2019 $ / shares shares	Sep. 30, 2020 Product $ / shares
Company Overview [Abstract]
Number of internally-developed proprietary products \| Product			1
Equity Offering of Common Stock [Abstract]
Net proceeds from initial public offering	$ 37,835
Payments for deferred offering costs	$ 2,415
Number of common shares issued (in shares) \| shares	8,050,000	8,050,000
Common stock, par value (in dollars per share) \| $ / shares	$ 0.001	$ 0.001	$ 0.001
Professional fees and other costs	$ 540

Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2019	Sep. 30, 2020
Recent Accounting Pronouncements [Abstract]
Right of use assets	$ 0	$ 3,609
Lease liabilities		3,711
ASU 2016-02 [Member]
Recent Accounting Pronouncements [Abstract]
Right of use assets	4,048	$ 4,048
Lease liabilities	$ 4,224
Incremental borrowing rate on lease payments	16.90%

Risks and Uncertainties (Details) - USD ($) $ in Thousands		1 Months Ended		9 Months Ended
Risks and Uncertainties (Details) - USD ($) $ in Thousands	Dec. 17, 2019	Dec. 31, 2019	Jul. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Risks and Uncertainties [Abstract]
Working capital				$ 13,311
Cash and cash equivalents		$ 49,326		17,064
Debt Instrument, Interest Rate [Abstract]
Accumulated deficit		(130,474)		(165,889)
Additional fund amount			$ 52,226
Proceeds from refinancing of debt			$ 13,110	$ 0	$ 70,000
Net proceeds from initial public offering		$ 37,295
Number of common shares issued (in shares)	8,050,000	8,050,000
Common Stock issued upon warrant exercises		$ 1,821
Senior Secured Notes Due 2025 [Member]
Debt Instrument, Interest Rate [Abstract]
Interest rate				12.50%

Revenues and Trade Receivables, Net, Revenue (Details) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020 USD ($) Sources	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) Sources	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)
Revenues and Trade Receivables, Net [Abstract]
Number of revenue sources \| Sources	4		4
Contract with Customer, Asset and Liability [Abstract]
Invoices payable term			75 days
Current and non-current contract assets	$ 8,922		$ 8,922		$ 4,363
Contract liabilities	4,416		4,416		$ 5,154
Revenue [Abstract]
Total revenues	8,260	$ 12,418	$ 38,700	$ 36,190
Minimum [Member]
Contract with Customer, Asset and Liability [Abstract]
Invoices payable term			30 days
Maximum [Member]
Contract with Customer, Asset and Liability [Abstract]
Invoices payable term			60 days
Manufacture and Supply Revenue [Member]
Revenue [Abstract]
Total revenues	5,903	9,155	$ 20,078	24,739
License and Royalty Revenue [Member]
Revenue [Abstract]
Total revenues	328	1,356	13,682	6,402
Co-Development and Research Fees [Member]
Revenue [Abstract]
Total revenues	341	1,073	870	2,862
Proprietary Product Sales, Net [Member]
Revenue [Abstract]
Total revenues	$ 1,688	$ 834	$ 4,070	$ 2,187

Revenues and Trade Receivables, Net, Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Revenues by Geographic Market [Abstract]
Total revenues	$ 8,260	$ 12,418	$ 38,700	$ 36,190
United States [Member]
Revenues by Geographic Market [Abstract]
Total revenues	6,567	11,022	35,496	33,683
Ex-United States [Member]
Revenues by Geographic Market [Abstract]
Total revenues	$ 1,693	$ 1,396	$ 3,204	$ 2,507

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Revenues and Trade Receivables, Net, Trade and other receivables, net (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Trade and other receivables, net [Abstract]
Trade receivables	$ 6,659	$ 9,094
Contract and other receivables	1,872	4,363
Less: allowance for bad debts	(264)	(124)	$ (58)
Less: sales-related allowances	(277)	(203)
Trade and other receivables, net	7,990	$ 13,130
Minimum [Member]
Trade and other receivables, net [Abstract]
Guaranteed royalty revenue	$ 1,000

Revenues and Trade Receivables, Net, Changes in Allowance for Bad Debt (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Allowance for Doubtful Accounts Receivable [Roll Forward]
Allowance for doubtful accounts at beginning of year	$ 124	$ 58
Additions charged to bad debt expense	140	66
Write-downs charged against the allowance	0	0
Allowance for doubtful accounts at end of the period	$ 264	$ 124

Revenues and Trade Receivables, Net, Summary of Activity with Sales Related Allowances and Accruals (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Revenues and Trade Receivables, Net [Abstract]
Beginning balance	$ 1,377
Provision	3,996
Payments / credits	(3,441)
Ending balance	1,932
Accrued balances - Trade and other receivables, net	277	$ 203
Accrued balances - Accounts payable and accrued expense	$ 1,655	$ 1,174

Revenues and Trade Receivables, Net, Concentration of Major Customers (Details) - Customer	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Revenue [Member]
Customer Concentration [Abstract]
Number of customers exceeding 10% thresholds	2
Revenue [Member] \| Indivior [Member]
Customer Concentration [Abstract]
Concentrations of risk	54.00%	86.00%
Revenue [Member] \| Sunovion [Member]
Customer Concentration [Abstract]
Concentrations of risk	31.00%
Receivables [Member]
Customer Concentration [Abstract]
Number of customers exceeding 10% thresholds	3
Receivables [Member] \| Indivior [Member]
Customer Concentration [Abstract]
Concentrations of risk	50.00%	80.00%
Receivables [Member] \| Sunovion [Member]
Customer Concentration [Abstract]
Concentrations of risk	12.00%
Receivables [Member] \| AmerisourceBergen [Member]
Customer Concentration [Abstract]
Concentrations of risk	11.00%

Material Agreements, Agreement with Indivior (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Mar. 31, 2019	Sep. 30, 2020	Feb. 20, 2019
Commercial Exploitation Agreement with Indivior [Member]
Commercial Exploitation Agreement [Abstract]
License agreement term		7 years
Automatic renewal period of agreement		1 year
Notice period of intent not to renew agreement		1 year
Supplemental Agreement with Indivior [Member]
Supplemental Agreement [Abstract]
Aggregate payments received			$ 40,750
Revenues	$ 4,250
Receivable, process patent rights		$ 1,250
Maximum payments under agreement		75,000
Supplemental Agreement with Indivior [Member] \| Maximum [Member]
Supplemental Agreement [Abstract]
Contingent payments receivable in the future		34,250
Aggregate revenue receivable, milestone payments and royalties		$ 33,000

Material Agreements, License Agreement with Sunovion Pharmaceuticals (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
License Agreement with Sunovion Pharmaceuticals, Inc. [Abstract]
Aggregate royalty receivable	$ 7,000	$ 0
Trade and other receivables, net	7,990	13,130
Intangible assets, net and other assets	7,402	$ 439
License Agreement with Sunovion Pharmaceuticals, Inc. [Member]
License Agreement with Sunovion Pharmaceuticals, Inc. [Abstract]
Payment receivable	4,000
Aggregate payments received	22,000
Upfront Payment Received	5,000
Aggregate milestone payments receivable	17,000
Maximum payments under agreement	45,000
Aggregate royalty receivable	8,000
Trade and other receivables, net	1,000
Intangible assets, net and other assets	7,000
License Agreement with Sunovion Pharmaceuticals, Inc. [Member] \| Royalty [Member]
License Agreement with Sunovion Pharmaceuticals, Inc. [Abstract]
Revenues	$ 8,000

Material Agreements, Agreement to Terminate CLA with KemPharm (Details) - Agreement to Terminate CLA with KemPharm [Member] - USD ($) $ in Thousands	1 Months Ended	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2020
Agreement to Terminate CLA with KemPharm [Abstract]
Revenues	$ 1,000	$ 500
Percentage share of milestone payments paid	10.00%
Maximum payments under agreement		$ 4,800

- Definition

Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 323
-SubTopic 10
-Section 50
-Paragraph 3
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=114001798&loc=d3e33918-111571

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 825
-SubTopic 10
-Section 50
-Paragraph 28
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=75031198&loc=d3e14064-108612

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9031-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9038-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI http://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(1))
-URI http://asc.fasb.org/extlink&oid=120395209&loc=SL114868664-224227

+ Details

Financial Instruments - Fair Value Measurements (Details)	Sep. 30, 2020
Senior Secured Notes Due 2025 [Member]
Warrants Liability [Abstract]
Interest rate	12.50%

Inventories, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Inventories, Net [Abstract]
Raw material	$ 1,153	$ 1,244
Packaging material	1,231	1,096
Finished goods	858	519
Total inventory, net	$ 3,242	$ 2,859

Property and Equipment, Net (Details) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 30, 2020

Sep. 30, 2019

Sep. 30, 2020

Sep. 30, 2019

Dec. 31, 2019

Property and Equipment, Net [Abstract]

Property and equipment, gross

$ 47,899

$ 47,770

Less: accumulated depreciation and amortization

(40,171)

(38,044)

Total property and equipment, net

7,728

9,726

Property Plant and Equipment Income Statement Disclosures [Abstract]

Depreciation and amortization

714

$ 695

2,127

$ 2,143

Machinery [Member]

Property and Equipment, Net [Abstract]

Property and equipment, gross

21,406

$ 21,406

21,088

Machinery [Member] | Minimum [Member]

Property and Equipment, Net [Abstract]

Useful lives

3 years

Machinery [Member] | Maximum [Member]

Property and Equipment, Net [Abstract]

Useful lives

15 years

Furniture and Fixtures [Member]

Property and Equipment, Net [Abstract]

Property and equipment, gross

1,209

$ 1,209

1,150

Furniture and Fixtures [Member] | Minimum [Member]

Property and Equipment, Net [Abstract]

Useful lives

3 years

Furniture and Fixtures [Member] | Maximum [Member]

Property and Equipment, Net [Abstract]

Useful lives

15 years

Leasehold Improvements [Member]

Property and Equipment, Net [Abstract]

Property and equipment, gross

^[1]

21,333

$ 21,333

21,333

Computer, Network Equipment and Software [Member]

Property and Equipment, Net [Abstract]

Property and equipment, gross

2,886

$ 2,886

2,787

Computer, Network Equipment and Software [Member] | Minimum [Member]

Property and Equipment, Net [Abstract]

Useful lives

3 years

Computer, Network Equipment and Software [Member] | Maximum [Member]

Property and Equipment, Net [Abstract]

Useful lives

7 years

Construction in Progress [Member]

Property and Equipment, Net [Abstract]

Property and equipment, gross

$ 1,065

$ 1,412

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

Right-of-Use Assets and Lease Obligations (Details) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2020 USD ($) Lease	Sep. 30, 2020 USD ($) Lease	Dec. 31, 2019 USD ($)
Right-of-Use Assets and Lease Obligations [Abstract]
Number of leases \| Lease	3	3
Lease, Cost [Abstract]
Estimated discount rate	16.90%	16.90%
Right of use assets	$ 3,609	$ 3,609	$ 0
Operating lease expense	409	1,228
Variable lease expense	89	255
Operating lease payments		1,255
Lessee, Operating Lease, Liability, Payment, Due [Abstract]
Remainder of 2020	266	266
2021	1,287	1,287
2022	1,295	1,295
2023	944	944
2024	565	565
2025	565	565
2026	424	424
Total lease payments	5,346	5,346
Less: imputed interest	(1,635)	(1,635)
Total operating lease liabilities	3,711	3,711
ASU 2016-02 [Member]
Lease, Cost [Abstract]
Right of use assets	$ 4,048	$ 4,048	4,048
Lessee, Operating Lease, Liability, Payment, Due [Abstract]
Total operating lease liabilities			$ 4,224
Minimum [Member]
Lease, Cost [Abstract]
Remaining lease term	2 years 6 months	2 years 6 months
Maximum [Member]
Lease, Cost [Abstract]
Remaining lease term	6 years	6 years

Intangible Assets, Net and Other Assets (Details) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) Payment	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)
Identifiable Intangible Assets [Abstract]
Intangible assets, gross	$ 2,867		$ 2,867		$ 2,867
Less: accumulated amortization	(2,752)		(2,752)		(2,714)
Intangible assets, net	115		115		153
Royalty receivable	7,000		7,000		0
Other assets, primarily security deposits	287		287		286
Total intangible assets, net and other assets	7,402		7,402		439
Amortization expense	13	$ 13	38	$ 39
Estimated Annual Amortization Expense [Abstract]
2020	50		50
2021	50		50
2022	50		50
Sunovion [Member]
Identifiable Intangible Assets [Abstract]
Royalty receivable	8,000		8,000
Total intangible assets, net and other assets	7,000		$ 7,000
Estimated Annual Amortization Expense [Abstract]
Number of annual royalty payments receivable \| Payment			7
Minimum annual royalty receivable	1,000		$ 1,000
Purchased Technology-based Intangible [Member]
Identifiable Intangible Assets [Abstract]
Intangible assets, gross	2,358		2,358		2,358
Purchased Patent [Member]
Identifiable Intangible Assets [Abstract]
Intangible assets, gross	$ 509		$ 509		$ 509

Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Accounts Payable and Accrued Expenses [Abstract]
Accounts payable	$ 9,169	$ 12,274
Accrued compensation	4,129	3,758
Accrued distribution expenses	1,655	1,174
Other	284	543
Total accounts payable and accrued expenses	$ 15,237	$ 17,749

12.5% Senior Secured Notes and Loans Payable, 12.5% Senior Secured Notes (Details) $ / shares in Units, $ in Thousands, shares in Millions		3 Months Ended		9 Months Ended
	Jul. 15, 2019 USD ($) Tranche	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)
12.5% Senior Secured Notes [Abstract]
Warrants issued (in shares) \| shares		2		2
Warrant exercise price (in dollars per share) \| $ / shares		$ 0.001		$ 0.001
Net proceeds from issuance of initial notes, warrants and first offer rights	$ 66,082
Loans payable, current		$ 1,750		$ 1,750		$ 0
Debt Maturity [Abstract]
Remainder of 2020		0		0
2021		3,500		3,500
2022		10,500		10,500
2023		17,500		17,500
2024		24,500		24,500
2025		14,000		14,000
Total		70,000		70,000
Amortization expense, deferred debt issuance costs and debt discounts				1,758	$ 1,338
Perceptive Credit Opportunities Fund, LP [Member] \| Line of Credit [Member]
12.5% Senior Secured Notes [Abstract]
Payment of existing debt obligation	$ (56,340)
Senior Secured Notes Due 2025 [Member]
12.5% Senior Secured Notes [Abstract]
Principal amount		$ 70,000		$ 70,000
Interest rate		12.50%		12.50%
Warrants issued (in shares) \| shares		2		2
Warrant exercise price (in dollars per share) \| $ / shares		$ 4.25		$ 4.25
Number of tranches \| Tranche	2
Frequency of periodic principal payment				quarterly
Debt maturity date				Jun. 30, 2025
Annual percentage increase in principal payments during first four quarters				10.00%
Annual percentage increase of initial loan principal payments during final four quarters				40.00%
Debt Maturity [Abstract]
Redemption percentage of debt under change of control provisions				101.00%
Amortization expense, deferred debt issuance costs and debt discounts		$ 590	$ 556	$ 1,758	$ 1,338
Unamortized deferred debt issuance cost and deferred debt discounts		7,904		$ 7,904		$ 9,662
Senior Secured Notes Due 2025 [Member] \| Minimum [Member]
Debt Maturity [Abstract]
Elective redemption percentage of debt				101.56%
Senior Secured Notes Due 2025 [Member] \| Maximum [Member]
12.5% Senior Secured Notes [Abstract]
Principal amount		100,000		$ 100,000
Additional borrowing capacity		30,000		$ 30,000
Debt Maturity [Abstract]
Elective redemption percentage of debt				112.50%
Asset based loans secured on second priority lien by receivables and inventory assets		10,000		$ 10,000
Senior Secured Notes Due 2025 - First Additional Offering [Member]
12.5% Senior Secured Notes [Abstract]
Additional borrowing capacity		10,000		10,000
Senior Secured Notes Due 2025 - First Additional Offering [Member] \| Maximum [Member]
Debt Maturity [Abstract]
Portion of proceeds used to monetize assets, if First Additional Offering has not been elected or funded				40,000
Senior Secured Notes Due 2025 - Second Additional Offering [Member]
12.5% Senior Secured Notes [Abstract]
Additional borrowing capacity		$ 20,000		20,000
Senior Secured Notes Due 2025 - Second Additional Offering [Member] \| Maximum [Member]
Debt Maturity [Abstract]
Portion of proceeds used to monetize assets, if First Additional Offering has been elected and funded				$ 50,000

12.5% Senior Secured Notes and Loans Payable, Perceptive (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Line of Credit Facility [Abstract]
Loss on extinguishment of debt	$ 0	$ (4,896)	$ 0	$ (4,896)
Prepayment premiums paid		$ 2,944	0	$ 2,944
Perceptive Credit Opportunities Fund, LP [Member] \| Line of Credit [Member]
Line of Credit Facility [Abstract]
Credit facility, maximum borrowing capacity	$ 50,000		$ 50,000
Warrant to purchase senior common equity interest ratio to fully diluted common units	4.50%		4.50%

Warrants Issued to 12.5% Senior Secured Noteholders (Details) - USD ($) $ / shares in Units, $ in Thousands		9 Months Ended
	Dec. 16, 2019	Sep. 30, 2020
Warrants [Abstract]
Number of shares received upon automatic exercise of warrant (in shares)		2,000,000
Warrant exercise price (in dollars per share)		$ 0.001
Proceeds from warrant exercises	$ 1,821
Exercise of warrants (in shares)		0
Common Stock [Member]
Warrants [Abstract]
Common Stock issued upon warrant exercises (in shares)	428,571
Senior Secured Notes Due 2025 [Member]
Warrants [Abstract]
Interest rate		12.50%
Debt maturity date		Jun. 30, 2025
Number of shares received upon automatic exercise of warrant (in shares)		2,000,000
Warrant exercise price (in dollars per share)		$ 4.25
Fair value of warrants		$ 6,800

Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Numerator [Abstract]
Net loss	$ (16,551)	$ (2,334)	$ (16,530)	$ (18,412)	$ (20,472)	$ (14,726)	$ (35,415)	$ (53,610)
Denominator [Abstract]
Weighted-average number of common shares outstanding - basic (in shares)	33,619,379			25,031,478			33,592,846	24,992,229
Loss per common share - basic and diluted (in dollars per share)	$ (0.49)			$ (0.74)			$ (1.05)	$ (2.15)
Dilutive Instruments [Abstract]
Total potentially antidilutive derivatives excluded from losses per share (in shares)							4,660,860	2,363,236
Options on Common Shares Outstanding [Member]
Dilutive Instruments [Abstract]
Total potentially antidilutive derivatives excluded from losses per share (in shares)							3,075,942	2,256,092
Restricted Stock Units Unvested [Member]
Dilutive Instruments [Abstract]
Total potentially antidilutive derivatives excluded from losses per share (in shares)							13,489	107,144
Warrants on Common Shares Outstanding [Member]
Dilutive Instruments [Abstract]
Total potentially antidilutive derivatives excluded from losses per share (in shares)							1,571,429	0

Share-Based Compensation (Details) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020 USD ($) Period $ / shares shares	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) Period $ / shares shares	Sep. 30, 2019 USD ($) shares
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	$ 1,427	$ 1,870	$ 5,052	$ 5,200
Manufacture and Supply [Member]
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	73	60	208	176
Research and Development [Member]
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	178	188	543	536
Selling, General and Administrative [Member]
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	1,176	1,622	4,301	4,480
Restricted Stock Units [Member]
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	$ 16	473	$ 789	1,403
Number of Units [Roll Forward]
Unvested, at beginning of period (in shares) \| shares			74,000
Granted (in shares) \| shares			4,000
Vested (in shares) \| shares			(64,000)
Forfeited (in shares) \| shares			0
Unvested, at end of period (in shares) \| shares	14,000		14,000
Weighted Average Grant Date Fair Value Per Share [Abstract]
Unvested, at beginning of period (in dollars per share)			$ 14.64
Granted (in dollars per share)			7.54
Vested (in dollars per share)			14.88
Forfeited (in dollars per share)			0
Unvested, at end of period (in dollars per share)	$ 11.38		$ 11.38
Grant date fair value of shares vested during the period \| $	$ 958		$ 958
Unrecognized compensation costs of RSU awards \| $	140		$ 140
Compensation Cost Not yet Recognized [Abstract]
Unrecognized compensation cost, recognition period			2 years
Stock Options [Member]
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	$ 1,411	1,397	$ 4,252	3,777
Number of Options [Roll Forward]
Outstanding at beginning of period (in shares) \| shares			2,231,000
Granted (in shares) \| shares			981,000
Exercised, Forfeited, Expired (in shares) \| shares			(136,000)
Outstanding at end of period (in shares) \| shares	3,076,000		3,076,000
Vested or expected to vest at end of period (in shares) \| shares	2,866,000		2,866,000
Exercisable at end of period (in shares) \| shares	1,014,000		1,014,000
Weighted Average Exercise Price [Abstract]
Outstanding at beginning of period (in dollars per share)			$ 10.42
Granted (in dollars per share)			2.68
Exercised, Forfeited, Expired (in dollars per share)			(4.39)
Outstanding at end of period (In dollars per share)	$ 8.22		8.22
Vested or expected to vest at end of period (in dollars per share)	8.22		8.22
Exercisable at end of period (in dollars per share)	11.87		$ 11.87
Fair Value Assumptions [Abstract]
Expected dividend yield			0.00%
Expected volatility			100.00%
Weighted average grant date fair value (in dollars per share)			$ 2.10
Additional Disclosures [Abstract]
Share price (in dollars per share)	$ 4.86		$ 4.86
Intrinsic value of options granted \| $			$ 2,474	0
Compensation Cost Not yet Recognized [Abstract]
Unrecognized compensation expense related to non-vested stock options \| $	$ 6,554		$ 6,554
Unrecognized compensation cost, recognition period			1 year 9 months 18 days
Stock Options [Member] \| Minimum [Member]
Weighted Average Exercise Price [Abstract]
Granted (in dollars per share)			$ 1.54
Fair Value Assumptions [Abstract]
Expected term (years)			5 years 6 months
Risk-free interest rate			0.40%
Stock Options [Member] \| Maximum [Member]
Weighted Average Exercise Price [Abstract]
Granted (in dollars per share)			$ 7.86
Fair Value Assumptions [Abstract]
Expected term (years)			6 years 1 month 6 days
Risk-free interest rate			1.70%
Employee Stock Purchase Plan [Member]
Share-based Compensation expenses [Abstract]
Share-based compensation expenses \| $	$ 0	$ 0	$ 11	$ 20
Employee Stock Purchase Plan [Abstract]
Number of offering periods \| Period	2		2
Purchase price of common stock as percentage of fair market value			85.00%
Shares issued under employee stock purchase plan (in shares) \| shares			14,961	31,393
Discount value on shares issued under employee stock purchase plan \| $			$ 11	$ 20

Income Taxes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Income Taxes (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Income Taxes [Abstract]
Income taxes	$ 0	$ 0	$ 0	$ 0
Net (loss)/income before income taxes	$ (16,551)	$ (18,412)	$ (35,415)	$ (53,610)
Federal statutory tax rate			21.00%

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=68072869&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI http://asc.fasb.org/extlink&oid=120395209&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI http://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI http://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI http://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Contingencies (Details)	1 Months Ended	9 Months Ended
Contingencies (Details)	Aug. 31, 2013 Company	Sep. 30, 2020 Case Patent States Cause
Litigation and Contingencies [Abstract]
Number of companies patent infringement lawsuits filed \| Company	6
Number of cases resolved		3
Number of additional infringement on patents \| Patent		2
Number of cases pending		3
Number of cases filed		4
Number of states in the antitrust litigation \| States		41
Humana and Centene Actions [Member]
Litigation and Contingencies [Abstract]
Number of causes alleged \| Cause		5
California Complaint [Member]
Litigation and Contingencies [Abstract]
Number of causes alleged \| Cause		3

Subsequent Events (Details) - USD ($) $ in Thousands			1 Months Ended	9 Months Ended
Subsequent Events (Details) - USD ($) $ in Thousands	Nov. 03, 2020	Oct. 23, 2020	Jul. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Senior Secured Notes [Abstract]
Repayment of Note				$ 0	$ 50,000
Proceeds from Issuance of Debt			$ 13,110	$ 0	$ 70,000
Number of shares callable by warrants (in shares)				2,000,000
Senior Secured Notes Due 2025 [Member]
Senior Secured Notes [Abstract]
Interest rate				12.50%
Number of shares callable by warrants (in shares)				2,000,000
Senior Secured Notes Due 2025 [Member] \| Maximum [Member]
Senior Secured Notes [Abstract]
Additional borrowing capacity				$ 30,000
Senior Secured Notes Due 2025 - First Additional Offering [Member]
Senior Secured Notes [Abstract]
Additional borrowing capacity				10,000
Senior Secured Notes Due 2025 - Second Additional Offering [Member]
Senior Secured Notes [Abstract]
Additional borrowing capacity				20,000
License Agreement with Sunovion Pharmaceuticals, Inc. [Member]
License Agreements [Abstract]
Maximum amount of payments receivable under agreement				$ 45,000
Subsequent Event [Member] \| Senior Secured Notes Due 2025 [Member]
Senior Secured Notes [Abstract]
Repayment of Note	$ 22,500
Proceeds from Issuance of Debt	4,000
Notes payable outstanding	$ 51,500
Number of shares callable by warrants (in shares)	714,000
Warrants issued to purchase common stock (in shares)	143,000
Subsequent Event [Member] \| License Agreement with Sunovion Pharmaceuticals, Inc. [Member]
License Agreements [Abstract]
Notice period of intent to terminate agreement		180 days
Maximum amount of payments receivable under agreement	$ 125,000
Cash payment receivable	40,000
Contingent payments receivable	$ 85,000