0001558370-23-014296 | 10-Q | XBRL Viewer

Summary of Significant Accounting Policies - Co-Payment Assistance (Details) - USD ($) $ in Millions	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Receivables [Abstract]
Provision for revenue reserve	$ 6.3	$ 1.6	$ 10.8	$ 2.8
Reserve for variable consideration	$ 7.1		$ 7.1

Credit Agreement and Guaranty

6 Months Ended

Jun. 30, 2023

Credit Agreement and Guaranty

Credit Agreement and Guaranty

7. Credit Agreement and Guaranty

On February 10, 2020, the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP (“Perceptive”) for a senior secured term loan credit facility of up to $35.0 million (the “Perceptive Credit Agreement”). A first tranche of $5.0 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15.0 million was funded as a result of the approval of Twirla by the FDA. The other tranches of debt under the Perceptive Credit Agreement are no longer available to the Company. On January 7, 2022, the Company prepaid $5.0 million of the outstanding debt, and Perceptive waived the prepayment premium. On July 8, 2022, the Company prepaid $5.0 million of the outstanding debt, and Perceptive waived the prepayment premium. On July 25, 2022, the Company entered into a fifth amendment to the Perceptive Credit Agreement, as amended (the “Fifth Amendment”). Pursuant to the Fifth Amendment, Perceptive agreed to release its security interest in certain assets being transferred from the Company to Corium in connection with an amendment to the Company’s Manufacturing and Commercialization Agreement with Corium and waive the Company’s obligations to comply with certain financial covenants through the end of 2022. In exchange, the Company agreed to prepay $7.0 million of outstanding principal under the Perceptive Credit Agreement using the proceeds of recent sales under the Company’s ATM program with H.C. Wainwright & Co., LLC (see Note 8). Such payment was made on July 25, 2022. On March 21, 2023, the Company and Perceptive entered into a sixth amendment to the Perceptive Credit Agreement (the “Sixth Amendment”). The Sixth Amendment waived the Company’s obligations to (1) comply with certain financial covenants relating to minimum revenue requirements and minimum liquidity through June 30, 2023, and (2) file financial statements along with its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 that are not subject to any “going concern” qualification.

The facility will mature on February 10, 2024 (“Maturity Date”). Pursuant to the Perceptive Agreement, beginning August 31, 2022, the Company began making monthly principal payments in an amount equal to $75,000, continuing until February 10, 2024, at which time all remaining principal amount outstanding is due.

Borrowings under the Perceptive Credit Agreement will accrue interest at an annual rate equal to the London Interbank Offered Rate for one-month deposits (“LIBOR”) plus 10.25%, provided that LIBOR shall not be less than 1.5%. The rate of interest in effect as of June 30, 2023 was 15.42%. Upon the occurrence and during the continuance of any event of default under the Perceptive Credit Agreement, the interest rate automatically increases by 3.0% per annum.

The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment premium of 2.0%.

All of the Company’s obligations under the Perceptive Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property. The Perceptive Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customary for similar financings. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain investments or restricted payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending September 30, 2023, report revenues for the trailing 12-month period that exceed the amounts set forth in the Sixth Amendment, which range from $80.5 million for the fiscal quarter ending September 30, 2023 to $87.1 million for the fiscal quarter ending December 31, 2023. Pursuant to the Sixth Amendment, the Company has received a waiver of certain financial covenants through the second quarter of 2023. In the event the Company does not pay off the remainder of the outstanding principal under the facility, in the second quarter of 2023, the Company will need to negotiate for a waiver of its obligations to comply with certain financial covenants.

In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 700 shares of the Company’s common stock (together, the “2020 Perceptive Warrants”). The first warrant is exercisable for 350 shares of common stock at an exercise price of $7,480 per share. The second warrant is exercisable for 350 shares of common stock at an exercise price of $9,340 per share. The 2020 Perceptive Warrants expire on February 10, 2027. In connection with the Perceptive Credit Agreement, the Company issued to

Perceptive a warrant to purchase 225 shares of the Company’s common stock (the “2021 Perceptive Warrant” and, together with the 2020 Perceptive Warrants, the “Perceptive Warrants”) at an exercise price of $5,740 per share. The 2021 Perceptive Warrant expires on February 26, 2028. The Perceptive Warrants contained anti-dilution provisions through June 30, 2023 and other warrant holder protections and are not exercisable to the extent that Perceptive would beneficially own more than 19.99% of the Company’s common stock as a result of the exercise. In connection with the Sixth Amendment, the Company amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants to $10.50 per warrant.

As a result of the public offering of the Company’s common stock completed in October 2021 (see Note 8), the antidilution provision of the Perceptive Warrants was triggered, resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $9,340 per share were reduced to $7,080 per share, warrants to purchase 350 shares of common stock that had an exercise price of $7,480 per share were reduced to $5,760 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $5,740 per share were reduced to $4,540 per share.

As a result of the registered direct offering completed in March 2022 (see Note 8), the anti-dilution provision of the Perceptive Warrants was again triggered resulting in a further reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an adjusted exercise price of $7,080 per share were reduced to $5,276 per share, warrants to purchase 350 shares of common stock that had an adjusted exercise price of $5,760 per share were reduced to $4,330.50 per share, and warrants to purchase 225 shares of common stock that had an adjusted exercise price of $4,540 per share were reduced to $3,456.50 per share.

As a result of the public offering of the Company’s common stock completed in July 2022 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $5,276 per share were reduced to $745 per share, warrants to purchase 350 shares of common stock that had an exercise price of $4,330.50 per share were reduced to $618.50 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $3,456.50 per share were reduced to $501.50 per share.

As a result of the public offering of the Company’s common stock completed in May 2023 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $745 per share were reduced to $3.69 per share, warrants to purchase 350 shares of common stock that had an exercise price of $618.50 per share were reduced to $3.69 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $501.50 per share were reduced to $3.69 per share.

The Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and the Perceptive Warrants. The relative fair value of the Perceptive Warrants of approximately $3.6 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in the preparation of the option pricing model for valuing the Perceptive Warrants issued include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 7-year life), (iii) strike prices of $7,480 and $9,340 for the common stock warrants, (iv) fair value of common stock ($8,020) and (v) expected life (7 years). The fair value of the 2021 Perceptive Warrants of approximately $1.1 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the 2021 Perceptive Warrants issued include (i) volatility (103.5%), (ii) risk free interest rate of 1.15% (estimated using treasury bonds with a 7-year life), (iii) strike price of $5,740 for the common stock warrant, (iv) fair value of common stock ($5,740) and (v) expected life (7 years). The fair value of the warrants as well as the debt issue costs incurred in connection with the entry into the Perceptive Credit Agreement, including a facility fee of 1% of the total amount of loans available under the facility, are presented as a direct deduction from the carrying amount of the term loan on the consolidated balance sheet as detailed below (in thousands).


	June 30,		December 31,
	2023		2022
Notes payable	$	2,175	$	2,625
Debt issuance costs		(107)		(209)
Warrant discount		(506)		(990)
Total debt	$	1,562	$	1,426
Less, current portion		1,562		1,426
Long-term debt, less current portion	$	—	$	—

The fair value of the warrants and the debt issue costs are being amortized utilizing the effective interest method over the term of the loan. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of $372,000 and $378,000 for the three months ended June 30, 2023 and 2022, respectively. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of $679,000 and $797,000 for the six months ended June 30, 2023 and 2022, respectively.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
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-Section 50
-Paragraph 1C
-Subparagraph (c)
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Section 50
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-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: 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(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Section 50
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-Subparagraph (g)
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-Publisher FASB
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-Paragraph 1E
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495348-112611

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Publisher FASB
-Name Accounting Standards Codification
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+ Details

Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Jun. 30, 2023	Jun. 30, 2022
Cash flows from operating activities:
Net loss	$ (9,197)	$ (15,553)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	51	1,057
Amortization	137	124
Noncash stock-based compensation	979	1,433
Noncash amortization of deferred financing costs	586	797
Unrealized gain on warrants	(3,361)	(8,435)
Changes in operating assets and liabilities:
Accounts receivable	(1,084)	(554)
Inventory	(1,204)	(1,374)
Prepaid expenses and other assets	1,873	1,267
Accounts payable and accrued expenses	1,260	3,643
Lease liability	(154)	(90)
Net cash used in operating activities	(10,114)	(17,685)
Cash flows from investing activities:
Acquisition of property and equipment		(133)
Net cash (used in) provided by investing activities		(133)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs	6,509
Repayments of long-term debt	(450)	(5,000)
Repayments of note payable	(61)
Net cash provided by (used in) financing activities	7,653	11,702
Net decrease in cash and cash equivalents	(2,461)	(6,116)
Cash and cash equivalents, beginning of period	5,246	19,143
Cash and cash equivalents, end of period	2,785	13,027
Supplemental disclosure of noncash financing activities
Warrants issued in connection with preferred stock offering		2,101
Supplemental cash flow information
Interest paid	93	898
Series A Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		897
Series B Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		887
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs	$ 1,655	$ 12,573

Credit Agreement and Guaranty (Details)					3 Months Ended	6 Months Ended
Credit Agreement and Guaranty (Details)	Jul. 25, 2022 USD ($)	Jul. 08, 2022 USD ($)	Jan. 07, 2022 USD ($)	Feb. 10, 2020 USD ($) item Y $ / shares shares	Dec. 31, 2023 USD ($)	Jun. 30, 2023 USD ($) Y $ / shares	Jun. 30, 2022 USD ($)	May 31, 2023 $ / shares shares	Dec. 31, 2022 USD ($) Y	Jul. 31, 2022 $ / shares shares	Mar. 31, 2022 $ / shares shares	Mar. 22, 2022 shares	Oct. 31, 2021 $ / shares shares	Feb. 26, 2021 $ / shares shares	Feb. 10, 2021 $ / shares shares
Credit Agreement and Guaranty
Repayments of debt						$ 450,000	$ 5,000,000
Interest rate (as a percent)						15.42%
Percentage of annual interest rate				3.00%
Exercise price of warrants (in dollars per share) \| $ / shares						$ 4.9439
Common stock that can be purchased with warrants (in shares) \| shares											24,856		6,660
Proceeds from warrant exercises				$ 20,000,000.0
Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares											225
Perceptive Credit Agreement
Credit Agreement and Guaranty
Repayments of debt		$ 5,000,000.0	$ 5,000,000.0
Prepayment of outstanding principal	$ 7,000,000.0
Monthly principal payments	$ 75,000
Variable interest rate margin (as a percent)				10.25%
Minimum cash covenants				$ 3,000,000.0
Revenue generated under debt					$ 87,100,000	$ 80,500,000
Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares				$ 10.50										$ 5,740
Common stock that can be purchased with warrants (in shares) \| shares				700										225
Number of warrants issued \| item				2
Beneficial ownership percentage				19.99%
Facility fee percentage				1.00%
Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares				$ 7,480				$ 3.69		$ 745	$ 5,276		$ 7,080		$ 7,480
Common stock that can be purchased with warrants (in shares) \| shares				350				350		350		350			350
Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares				$ 9,340				$ 3.69		$ 618.50	$ 4,330.50		$ 5,760		$ 9,340
Common stock that can be purchased with warrants (in shares) \| shares				350				350		350	350		350
Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares								$ 3.69		$ 501.50	$ 3,456.50		$ 4,540	$ 5,740
Common stock that can be purchased with warrants (in shares) \| shares								225		225			225
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Maximum borrowing capacity				$ 35,000,000.0
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche One
Credit Agreement and Guaranty
Amount borrowed				5,000,000.0
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche Two
Credit Agreement and Guaranty
Amount borrowed				$ 15,000,000.0
Minimum London Interbank Offered Rate (LIBOR) [Member] \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Interest rate for the base rate				1.50%
Prepayment Occur on or Before February, 10, 2024 \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Prepayment premium percentage				2.00%
Two Thousand Twenty Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants				$ 3,600,000
Two Thousand Twenty One Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants				$ 1,100,000
Option pricing model \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input						2.95			11.50
Option pricing model \| Maximum \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input						5.4			4.7
Option pricing model \| Maximum \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y						4.9			4.5
Option pricing model \| Minimum \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input						4.13			4.2
Option pricing model \| Minimum \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y						0.1			0.7
Option pricing model \| Common stock warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input						3.69
Option pricing model \| Common stock warrants \| Maximum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input						1,700.00			1,700
Option pricing model \| Common stock warrants \| Minimum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input						45.00			45.00
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Volatility
Credit Agreement and Guaranty
Warrants, Measurement Input				70.0
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input \| item				1.47
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y				7
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input				8,020
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Maximum \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input				9,340
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Minimum \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input				7,480
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Volatility
Credit Agreement and Guaranty
Warrants, Measurement Input				103.5
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input \| item				1.15
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y				7
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input				5,740
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Credit Agreement \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y				7

Summary of Significant Accounting Policies - Warrants (Details) - shares	May 31, 2023	Jul. 31, 2022	Jul. 06, 2022	Apr. 30, 2022	Mar. 31, 2022	Oct. 31, 2021	Feb. 28, 2021	Feb. 26, 2021	Feb. 29, 2020	Feb. 10, 2020
Warrants
Common stock that can be purchased with warrants (in shares)				4,243
Common stock that can be purchased with warrants (in shares)					24,856	6,660
Public offering
Warrants
Common stock that can be purchased with warrants (in shares)	3,792,572	1,093,333
Common stock that can be purchased with warrants (in shares)			150,366			6,660
Warrants
Warrants
Common stock that can be purchased with warrants (in shares)					225
Perceptive Credit Agreement \| Warrants
Warrants
Common stock that can be purchased with warrants (in shares)	225	225				225
Perceptive Credit Agreement \| Perceptive Warrants
Warrants
Common stock that can be purchased with warrants (in shares)							225		700
Common stock that can be purchased with warrants (in shares)								225		700

Fair Value Measurements - Level 3 Warrants (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Transfers between fair value levels	$ 0	$ 0
Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	5,934
Warrants issued	10,615
Change in fair value	(7,454)
Ending balance	$ 9,095

Income Taxes

6 Months Ended

Jun. 30, 2023

Income Taxes

Income Taxes

9. Income Taxes

Sale of New Jersey Net Operating Losses

The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. The Company had previously reached the maximum lifetime benefit of $15.0 million under the historical Program; however, in January 2021 the Program was amended to extend the maximum lifetime benefit to $20.0 million. The Company received final approval in March 2022 for $4.7 million of additional cash benefit that was received in April 2022.

- 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

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: 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(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Accrued Liabilities (Tables)

6 Months Ended

Jun. 30, 2023

Accrued Liabilities

Schedule of accrued liabilities

Accrued liabilities consist of the following (in thousands):


	June 30,		December 31,
	2023		2022
Gross to net accruals	$	3,556	$	2,332
Accrued compensation		2,242		833
Accrued professional fees and other		949		743
Total accrued liabilities	$	6,747	$	3,908

Prepaid Expenses and Other Current Assets

6 Months Ended

Jun. 30, 2023

Prepaid Expenses

Prepaid Expenses and Other Current Assets

4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):


	June 30,		December 31,
	2023		2022
Prepaid insurance	$	968	$	628
Other		898		775
Total prepaid expenses and other current assets	$	1,866	$	1,403

Stockholders Deficit - Stock-Based Compensation Expense (Details) - Common stock options - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 482	$ 669	$ 979	$ 1,433
Cost of goods sold
Stock-Based Compensation Expense
Total stock-based compensation expense	28	31	57	75
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	81	91	168	194
Selling and marketing
Stock-Based Compensation Expense
Total stock-based compensation expense	32	40	62	80
General and administrative
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 341	$ 507	$ 692	$ 1,084

Fair Value Measurements

6 Months Ended

Jun. 30, 2023

Fair Value Measurements

Fair Value Measurements

3. Fair Value Measurements

ASC 820, Fair Value Measurements and Disclosures, describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure 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 at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the

use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:

●

Level 1 — Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities.

●

Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities.

●

Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company has no Level 3 assets. Level 3 liabilities consist of warrant liability.

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of June 30, 2023 and December 31, 2022 (in thousands):


	Level 1		Level 2		Level 3
June 30, 2023
Assets:
Cash and cash equivalents	$	2,785	$	—	$	—
Total assets at fair value	$	2,785	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	9,095
Total assets at fair value	$	—	$	—	$	9,095


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934

The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of June 30, 2023 include (i) volatility 53.8% - 132.15%, (ii) risk-free interest rate 4.13% - 5.4%, (iii) strike price for the common warrants of $3.69, $45.00 and $1,700.00, (iv) fair value of common stock $2.95 and (v) expected life 0.1 - 4.9 years. The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2022 include (i) volatility 136.8% - 137.4%, (ii) risk-free interest rate 4.2% - 4.7%, (iii) strike price for the common warrants $45.00 and $1,700, (iv) strike price for the preferred warrants of $520.00, (v) fair value of common stock $11.50 and (vi) expected life 0.7 - 4.5 years.

The following is a roll forward of the fair value of Level 3 warrants:


Beginning balance at December 31, 2022	$	5,934
Warrants issued		10,615
Change in fair value		(7,454)
Ending Balance June 30, 2023	$	9,095

There were no transfers between Level 1, 2 or 3 during the six months ended June 30, 2023 or 2022.

- 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

Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Interest expense [Member]
Deferred Financing Costs
Amortization of deferred financing costs	$ 49,000	$ 66,000	$ 102,000	$ 139,000

Organization and Description of Business

6 Months Ended

Jun. 30, 2023

Organization and Description of Business

Organization and Description of Business

1. Organization and Description of Business

Nature of Operations

Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla^®, and more recently commercializing Twirla. The Company is headquartered in Princeton, New Jersey.

The Company’s sole approved product, Twirla, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA, in February 2020 and was commercially launched in early December 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has generated minimal product revenue to date and is subject to a number of risks similar to those of other early stage commercial companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the potential need to obtain additional capital necessary to fund the development of its products, reliance on a consistent supply chain both for Twirla and in general, macroeconomic factors such as inflation, competition from larger companies, and compliance with FDA and other government regulations. If the Company does not continue to successfully commercialize Twirla, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of June 30, 2023, the Company had an accumulated deficit of approximately $417.9 million. The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company:

●

maintains a sales and marketing infrastructure and contract manufacturing arrangement to support the continued commercialization of Twirla in the United States;

●

continues to commercialize Twirla and seek increased uptake of Twirla in the United States;

●

continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla;

●

maintains, leverages, and expands the Company’s intellectual property portfolio; and

●

maintains operational, financial, and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts.

The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 8), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding.

Going Concern

As of June 30, 2023, the Company had cash and cash equivalents of $2.8 million and a $3.7 million working capital deficit. The Company’s current liquidity is sufficient to fund operations into September 2023. The Company closely monitors its cash and cash equivalents and will need to raise additional funds to meet its projected operating requirements, including the continued commercialization of Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities.

The Company has generated losses since inception, used substantial cash in operations, has a working capital deficit at June 30, 2023, and anticipates it will continue to incur net losses for the foreseeable future. The Company’s future success depends on its ability to obtain additional capital and/or implement various strategic alternatives, and there can be no assurance that any financing can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern through the 12 months following the date on which this Quarterly Report on Form 10-Q is filed.

The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives, or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities.

The unaudited financial statements as of June 30, 2023 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan and successfully commercialize Twirla. The unaudited financial statements as of June 30, 2023 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements.

Basis of Presentation

The accompanying unaudited interim financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for Quarterly Reports on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP has been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 23, 2023.

In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods presented. The results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the operating results for the full fiscal year or any future period.

The accompanying unaudited financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. If the Company encounters unforeseen factors that impact the Company’s current business plan or its ability to generate revenue from the commercialization of Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations.

Statements of Changes in Stockholders' Deficit (Parenthetical)	Apr. 10, 2023
Statements of Changes in Stockholders' Deficit
Stockholders' Equity Note, Stock Split, Conversion Ratio	0.02

Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2023

Summary of Significant Accounting Policies

Basis of Presentation

Use of Estimates

The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, costs of product revenues,

inventory reserves, the accounting for common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates.

Risks and Uncertainties

Risks and Uncertainties

While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed, or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations.

It should be noted that the possibility of continued public health threats could adversely affect the Company’s ongoing or planned business operations. For example, the coronavirus (“COVID-19”) pandemic previously resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The most significant impacts to the Company’s business were encountered by sales representatives promoting Twirla in the field, as some offices limited opportunities for face-to-face interactions with healthcare providers. Re-implementation of COVID-19 restrictions, if necessary in the future, may disrupt the Company’s business and/or could adversely affect the Company’s commercialization plans and results. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom the Company engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. Another shutdown necessitating work in a completely remote environment could result in delays to its business activities and commercialization plan. The Company will continue to closely monitor events as they develop, and plan for alternative and mitigating measures that can be implemented if needed.

Cash and Cash Equivalents

Cash and Cash Equivalents

The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations.

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Trade Accounts Receivable and Allowances

Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward-looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of June 30, 2023 and December 31, 2022.

Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents (see Note 3) and the Company’s warrant liability (see Note 3) are carried at fair value. The warrant liability is measured at fair value in accordance with ASC 815.

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Inventory

Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of June 30, 2023 and December 31, 2022, inventory reserves approximated $1.1 million and $0.6 million, respectively.

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe the carrying values of any long-lived assets are impaired as of June 30, 2023.

Research and Development Expense

Research and Development Expenses

Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees, and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development.

In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received.

Advertising Costs

Advertising Costs

The Company has elected to expense advertising costs when incurred. Advertising costs totaled zero and $1.9 million for the three months ended June 30, 2023 and 2022, respectively, and totaled zero and $5.2 million for the six months ended June 30, 2023 and 2022, respectively.

Deferred Financing Costs

Deferred Financing Costs

Costs directly attributable to the Company’s senior secured term loan (see Note 7) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $49,000 and $66,000 for the three months ended June 30, 2023 and 2022, respectively and was approximately $102,000 and $139,000 for the six months ended June 30, 2023 and 2022, respectively.

Concentrations of Credit Risk

Concentrations of Credit Risk

Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents, and accounts receivable. The Company invests its cash and cash equivalents in interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity, and have a high credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has no financial instruments with off balance sheet risk of accounting loss.

Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three months ended June 30, 2023, the Company had sales to four customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.3 million, $1.2 million, $1.1 million, and $0.8 million, respectively, which represented 83% of total revenues in the three months ended June 30, 2023. In the six months ended June 30, 2023, the Company had sales to four customers that individually accounted for more than

10% of its total revenue. These customers had sales of $2.2 million, $2.1 million, $1.9 million and $1.9 million, respectively, which represented 87% of total revenue for the six months ended June 30, 2023. Accounts receivable related to these four customers comprised 30%, 21%, 21%, and 12%, of the Company’s total accounts receivable, respectively, as of June 30, 2023. In the three months ended June 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $0.7 million, $0.6 million, and $0.6 million, respectively, which represented 88% of total revenues in the three months ended June 30, 2022. In the six months ended June 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.2 million, $1.1 million, and $1.1 million, respectively, which represented 88% of total revenues in the six months ended June 30, 2022.

Revenue Recognition

Revenue Recognition

The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable and Allowance policy.

The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.

Twirla is sold to customers at the wholesale acquisition cost (“WAC”). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following:

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period.

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data continues to become available, the Company will incorporate that data into its estimates of variable consideration.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows:

Distribution services fees – The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra trade accounts receivable on the balance sheet.

Prompt pay and other discounts – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice and the Company offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the WAC. Prompt pay discount estimates are recorded as contra trade accounts receivable on the balance sheet.

The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded.

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and with limited historical sales data, an estimate for product returns as of June 30, 2023 was made based on industry standard data and trend analysis. Estimated product returns are recorded as other current liabilities in accrued expenses on the balance sheet.

Chargebacks – Certain covered entities and government entities will be able to purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the balance sheet.

Rebates – The Company will be subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities in accrued expenses on the balance sheet.

Co-payment assistance – The Company offers a co-payment assistance program to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of co-payment assistance based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment assistance estimates are recorded as other current liabilities in accrued expenses on the balance sheet.

Provisions for the revenue reserves described above totaled $6.3 million and $1.6 million for the three months ended June 30, 2023 and 2022, respectively, and $10.8 million and $2.8 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, reserves on the balance sheet associated with variable consideration were $7.1 million.

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

In connection with entering into a senior secured term loan facility in February 2020 (the “Perceptive Credit Agreement”), the Company issued warrants to purchase 700 shares of its common stock to the lender, Perceptive

Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase 225 shares of the Company’s common stock (collectively, the “Perceptive Warrants”). The Perceptive Warrants qualify for equity classification and have been allocated based upon the relative fair value of the base instrument and the warrant. The Perceptive Warrants were subject to repricing in the event of an offering of securities at a price lower than the existing strike price before June 30, 2023. In March 2023, in connection with the Waiver and Sixth Amendment to the Perceptive Credit Agreement, the Company amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants. See Notes 7 and 8 for additional information.

In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 6,660 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information.

In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase 24,856 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information.

In connection with a letter agreement and waiver entered into with an investor on April 2022, the Company issued warrants to purchase 4,243 shares of common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. See Note 8 for additional information.

In connection with a public offering completed in July 2022, the Company issued warrants to purchase 1,093,333 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants.

In connection with a public offering completed in May 2023, the Company issued warrants to purchase 3,792,572 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants.

Income Taxes

Income Taxes

The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.

The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of June 30, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance.

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to no less than the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.

The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore, basic and diluted net loss per share were the same for all periods presented.

The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022, respectively, because to do so would be anti-dilutive (in common equivalent shares):


	June 30,
	2023	2022
Common stock warrants	5,017,410	36,691
Unvested restricted stock units	135,047	142
Common stock options	43,510	5,778
Total	5,195,967	42,611

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures.

The Company did not adopt any new accounting pronouncements during the six months ended June 30, 2023 that had a material effect on its financial statements.

Leases - Summary (Details)	3 Months Ended		6 Months Ended
Leases - Summary (Details)	Jun. 30, 2023 USD ($) lease	Jun. 30, 2022 USD ($)	Jun. 30, 2023 USD ($) lease	Jun. 30, 2022 USD ($)
Leases
Number of finance leases \| lease	0		0
Number of operating leases \| lease	1		1
Lessee, Operating Lease, Existence of Option to Extend [true false]			true
Renewal term	5 years		5 years
Operating lease expense \| $	$ 89,000	$ 89,000	$ 178,000	$ 182,000
Operating lease expense information:
Cash paid for amounts included in measurement of lease liabilities \| $			$ 154,000	$ 90,000
Weighted-average remaining lease term (years)	1 year 9 months		1 year 9 months
Weighted-average discount rate	11.80%		11.80%

Leases (Tables)

6 Months Ended

Jun. 30, 2023

Leases

Maturity of lease liabilities

Future minimum lease payments under non-cancellable leases as of June 30, 2023 were as follows (in thousands):


2023	$	195
2024		397
2025		101
Total	$	693
Less: Interest		(64)
Present value of lease liability	$	629

Accrued Liabilities

6 Months Ended

Jun. 30, 2023

Accrued Liabilities

Accrued Liabilities

5. Accrued Liabilities

Accrued liabilities consist of the following (in thousands):


	June 30,		December 31,
	2023		2022
Gross to net accruals	$	3,556	$	2,332
Accrued compensation		2,242		833
Accrued professional fees and other		949		743
Total accrued liabilities	$	6,747	$	3,908

Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Statements of Operations and Comprehensive Loss
Revenues, net	$ 5,503	$ 2,126	$ 9,316	$ 3,887
Cost of product revenues	2,307	2,231	4,310	3,758
Gross profit	3,196	(105)	5,006	129
Operating expenses:
Research and development	703	856	1,466	2,113
Selling and marketing	4,570	7,411	9,240	17,964
General and administrative	3,049	3,026	6,133	7,023
Total operating expenses	8,322	11,293	16,839	27,100
Loss from operations	(5,126)	(11,398)	(11,833)	(26,971)
Other income (expense)
Interest income	15	2	48	3
Interest expense	(372)	(823)	(773)	(1,695)
Unrealized gain on warrant liability	1,674	7,051	3,361	8,435
Total other income, net	1,317	6,230	2,636	6,743
Loss before benefit from income taxes	(3,809)	(5,168)	(9,197)	(20,228)
Benefit from income taxes				4,675
Net loss and comprehensive loss	$ (3,809)	$ (5,168)	$ (9,197)	$ (15,553)
Net loss per share (basic) (in dollars per share)	$ (2.15)	$ (57.29)	$ (6.85)	$ (203.76)
Net loss per share (diluted) (in dollars per share)	$ (2.15)	$ (57.29)	$ (6.85)	$ (203.76)
Weighted-average common shares (basic) (in shares)	1,769,803	90,204	1,343,293	76,331
Weighted-average common shares (diluted) (in shares)	1,769,803	90,204	1,343,293	76,331

Leases - Maturity of lease liabilities (Details) $ in Thousands	Jun. 30, 2023 USD ($)
Operating Leases
2023	$ 195
2024	397
2025	101
Total	693
Less: Interest	(64)
Present value of lease liability	$ 629

Credit Agreement and Guaranty (Tables)

6 Months Ended

Jun. 30, 2023

Credit Agreement and Guaranty

Schedule of carrying amount of term loan


	June 30,		December 31,
	2023		2022
Notes payable	$	2,175	$	2,625
Debt issuance costs		(107)		(209)
Warrant discount		(506)		(990)
Total debt	$	1,562	$	1,426
Less, current portion		1,562		1,426
Long-term debt, less current portion	$	—	$	—

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 210
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-Paragraph 1
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-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 3
-Subparagraph (SX 210.12-04(a))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e24072-122690

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-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 6
-URI https://asc.fasb.org/extlink&oid=126973232&loc=d3e21506-112644

Reference 5: http://www.xbrl.org/2003/role/exampleRef
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-Name Accounting Standards Codification
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Reference 7: http://www.xbrl.org/2003/role/exampleRef
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+ Details

Income Taxes - Sale of New Jersey Net Operating Losses (Details) - USD ($) $ in Millions	1 Months Ended
	Apr. 30, 2022	Jan. 31, 2021	Jan. 31, 2018
Sale of New Jersey Net Operating Losses
Additional cash benefit received	$ 4.7
Sale of unused NOLs \| New Jersey
Sale of New Jersey Net Operating Losses
Maximum lifetime benefit under the Program		$ 20.0	$ 15.0
Sale of unused NOLs \| New Jersey \| Minimum
Sale of New Jersey Net Operating Losses
Allowable sale of unused tax benefits as a percentage of total value			80.00%

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Prepaid Expenses
Prepaid insurance	$ 968	$ 628
Other	898	775
Total prepaid expenses and other current assets	$ 1,866	$ 1,403

Accrued Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Accrued Liabilities
Gross to net accruals	$ 3,556	$ 2,332
Accrued compensation	2,242	833
Accrued professional fees and other	949	743
Total accrued liabilities	$ 6,747	$ 3,908

Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details)	3 Months Ended		6 Months Ended
	Jun. 30, 2023 USD ($) customer	Jun. 30, 2022 USD ($) customer	Jun. 30, 2023 USD ($) customer	Jun. 30, 2022 USD ($) customer
Concentration risk, financial liabilities
Financial instruments with off-balance sheet risk of accounting loss, liabilities	$ 0		$ 0
Total revenue	5,503,000	$ 2,126,000	9,316,000	$ 3,887,000
Customer Concentration Risk \| Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer				3
Customer Concentration Risk \| Sales Revenue \| Customer One
Concentration risk, financial liabilities
Total revenue	1,300,000	700,000	2,200,000	$ 1,200,000
Customer Concentration Risk \| Sales Revenue \| Customer Two
Concentration risk, financial liabilities
Total revenue	1,200,000	600,000	2,100,000	1,100,000
Customer Concentration Risk \| Sales Revenue \| Customer Three
Concentration risk, financial liabilities
Total revenue	1,100,000	$ 600,000	1,900,000	$ 1,100,000
Customer Concentration Risk \| Sales Revenue \| Customer Four
Concentration risk, financial liabilities
Total revenue	$ 800,000		$ 1,900,000
Customer Concentration Risk \| Sales Revenue \| Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer		3
Concentration risk, percentage		88.00%		88.00%
Customer Concentration Risk \| Sales Revenue \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer	4		4
Total revenue			$ 87
Concentration risk, percentage	83.00%
Customer Concentration Risk \| Accounts Receivable \| Customer One
Concentration risk, financial liabilities
Concentration risk, percentage			30.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Two
Concentration risk, financial liabilities
Concentration risk, percentage			21.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Three
Concentration risk, financial liabilities
Concentration risk, percentage			21.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Four
Concentration risk, financial liabilities
Concentration risk, percentage			12.00%
Customer Concentration Risk \| Accounts Receivable \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer				4

Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Millions	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Summary of Significant Accounting Policies
Inventory reserve	$ 1.1	$ 0.6

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	5,195,967	42,611
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	5,017,410	36,691
Unvested restricted stock units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	135,047	142
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	43,510	5,778

Balance Sheets - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 2,785	$ 5,246
Accounts receivable, net	4,461	3,377
Inventory, net	2,537	1,332
Prepaid expenses and other current assets	1,866	1,403
Total current assets	11,649	11,358
Property and equipment, net	126	177
Right of use asset	558	695
Other non-current assets	238	2,012
Total assets	12,571	14,242
Current liabilities:
Long-term debt, current portion	1,562	1,426
Notes payable, current portion	502
Accounts payable	6,156	7,734
Accrued expenses	6,747	3,908
Lease liability, current portion	342	319
Total current liabilities	15,309	13,387
Lease liabilities, long-term	288	466
Warrant liability	9,095	5,934
Total liabilities	24,692	19,787
Commitments and contingencies (Note 10)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at June 30, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 1,640,805 and 859,402 issued and outstanding at June 30, 2023 and December 31, 2022, respectively
Additional paid-in capital	405,779	403,157
Accumulated deficit	(417,900)	(408,702)
Total stockholders' deficit	(12,121)	(5,545)
Total liabilities and stockholders' deficit	$ 12,571	$ 14,242

Leases

6 Months Ended

Jun. 30, 2023

Leases

Leases

6. Leases

The Company has no finance leases and one operating lease for its corporate headquarters in Princeton, NJ. The current lease commenced on December 1, 2021 and terminates on March 31, 2025. The lease provides the Company with an option to extend the lease for an additional five years. Under the terms of the lease, the Company pays base annual rent subject to a fixed dollar amount increase each year, a fixed monthly charge for electricity, and other normal operating expenses such as taxes, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The lease does not require variable lease payments, residual value guarantees, or restrictive covenants.

The lease does not provide an implicit rate, therefore the Company used its incremental borrowing rate as the discount rate when measuring the operating lease liability. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease.

Operating lease expense was $89,000 and $89,000 for the three months ended June 30, 2023 and 2022, respectively. Operating lease expense was $178,000 and $182,000 for the six months ended June 30, 2023 and 2022, respectively. Operating cash flows used for operating leases during the six months ended June 30, 2023 and 2022 were approximately $154,000 and $90,000 respectively. As of June 30, 2023, the weighted average remaining lease term was 1.75 years, and the weighted average discount rate was 11.8%.

Future minimum lease payments under non-cancellable leases as of June 30, 2023 were as follows (in thousands):


2023	$	195
2024		397
2025		101
Total	$	693
Less: Interest		(64)
Present value of lease liability	$	629

Fair Value Measurements (Tables)

6 Months Ended

Jun. 30, 2023

Fair Value Measurements

Schedule of financial instruments measured at fair value by level within the fair value hierarchy

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of June 30, 2023 and December 31, 2022 (in thousands):


	Level 1		Level 2		Level 3
June 30, 2023
Assets:
Cash and cash equivalents	$	2,785	$	—	$	—
Total assets at fair value	$	2,785	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	9,095
Total assets at fair value	$	—	$	—	$	9,095


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934

Schedule of rollforward of the fair value of Level 3 warrants


Beginning balance at December 31, 2022	$	5,934
Warrants issued		10,615
Change in fair value		(7,454)
Ending Balance June 30, 2023	$	9,095

Stockholders Deficit - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions									1 Months Ended			3 Months Ended				6 Months Ended		9 Months Ended	12 Months Ended
	Aug. 22, 2022	Jul. 06, 2022	Apr. 27, 2022	Apr. 25, 2022	Apr. 04, 2022	Mar. 15, 2022	Mar. 14, 2022	Jan. 10, 2022	May 31, 2023	Oct. 31, 2021	Mar. 31, 2021	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Sep. 30, 2022	Dec. 31, 2022	Apr. 12, 2023	Jul. 31, 2022	Apr. 14, 2022	Oct. 02, 2020
Sale of stock
Issuance of common stock (in shares)		150,366
Common stock that can be purchased with warrants (in shares)										6,660					24,856
Share price (in dollars per share)									$ 3.9551
Exercise price of warrants (in dollars per share)												$ 4.9439				$ 4.9439
Stock stated value												$ 0.0001				$ 0.0001			$ 0.0001
Maximum
Sale of stock
Proceeds from issuance of common stock in public offering, net of offering costs	$ 75.0
Common stock
Sale of stock
Stock Issued During Period, Shares, Warrants Exercised												508,286
Conversion of stock shares converted						6,025
Conversion of convertible preferred stock (in shares)					6,025
Series A-1 warrants
Sale of stock
Warrant Exercisable Term		5 years
Series A-2 warrants
Sale of stock
Exercisable term		13 months
Series B Warrants
Sale of stock
Issuance of common stock (in shares)					2,425
Warrants and rights outstanding, term							5 years
Pre-funded warrants
Sale of stock
Stock Issued During Period, Shares, Warrants Exercised																508,286
Class of Warrant or Right, Exercisable												1,293,000				1,293,000
2020 Shelf Registration Statement
Sale of stock
Aggregate amount of securities issuable																							$ 200.0
2022 Preferred Stock Offering
Sale of stock
Common stock that can be purchased with warrants (in shares)							606
Proceeds from issuance of common stock in public offering, net of offering costs							$ 4.1
Exercise price of warrants (in dollars per share)							$ 500.00
Conversion price							$ 400.00
Preferred Stock, convertible, shares issuable							12,125
Exercisable term							6 months
Stock stated value							$ 1,000
Duration From Offering To Anniversary Of Closing				180 days
2022 Preferred Stock Offering \| Series A Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)				4,243			12,125
Exercise price of warrants (in dollars per share)																						$ 520.00
Exercisable term							6 months
Warrants and rights outstanding, term							5 years
Warrant Exercisable Term				5 years
2022 Preferred Stock Offering \| Series B Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)							12,125
Exercisable term							6 months
Warrants and rights outstanding, term							1 year 6 months
At-the-market sales \| Common stock
Sale of stock
Issuance of common stock (in shares)												105,342	72,699	173,750,000	512,000
Proceeds from issuance of common stock in public offering, net of offering costs																			$ 9.3
At-the-market sales \| Common stock \| Maximum
Sale of stock
Commission percentage			3.00%								3.00%
Authorized value for shares issuance			$ 12.8								$ 50.0
Public offering
Sale of stock
Issuance of common stock (in shares)		382,966							3,792,572
Common stock that can be purchased with warrants (in shares)		150,366								6,660
Share price (in dollars per share)																					$ 45.00
Public offering \| Common stock
Sale of stock
Issuance of common stock (in shares)		22,000,000.0							95,000	13,333		95,000
Common stock that can be purchased with one-half of warrant (in shares)										1
Share price (in dollars per share)										$ 1,700
Proceeds from issuance of common stock in public offering, net of offering costs										$ 21.1						$ 6.5
Public offering \| Pre-funded warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)									1,801,286
2022 ATM
Sale of stock
Issuance of common stock (in shares)																178,041		173,750	78,852
Proceeds from issuance of common stock in public offering, net of offering costs																$ 1.7		$ 12.2	$ 0.9
Eligible Amount Authorized To Sell																				$ 4.5
2022 ATM \| Common stock
Sale of stock
Issuance of common stock (in shares)											3,457						512
Proceeds from issuance of common stock in public offering, net of offering costs																$ 0.3
2022 ATM \| Common stock \| Maximum
Sale of stock
Commission percentage								3.00%
Authorized value for shares issuance								$ 50.0
2022 ATM \| New Warrant [Member]
Sale of stock
Warrant Exercisable Term				6 months
H.C. Wainwright & Co., LLC, Sales Agent [Member]
Sale of stock
Common stock that can be purchased with warrants (in shares)		26,666										94,814				94,814
Commission percentage		7.00%														7.00%
Exercise price of warrants (in dollars per share)		$ 56.25
Series A Preferred Stock
Sale of stock
Conversion of stock shares converted						2,425
Series A Preferred Stock \| 2022 Preferred Stock Offering
Sale of stock
Issuance of common stock (in shares)							2,425
Exercise price of warrants (in dollars per share)				$ 520
Series B Preferred Stock \| 2022 Preferred Stock Offering
Sale of stock
Issuance of common stock (in shares)							2,425
Exercise price of warrants (in dollars per share)																						$ 520.00

Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Summary of Significant Accounting Policies
Advertising costs	$ 0.0	$ 1.9	$ 0.0	$ 5.2

Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Credit Agreement and Guaranty
Notes payable	$ 2,175,000		$ 2,175,000		$ 2,625,000
Debt issuance costs	(107,000)		(107,000)		(209,000)
Warrant discount	(506,000)		(506,000)		(990,000)
Total debt	1,562,000		1,562,000		1,426,000
Less, current portion	1,562,000		1,562,000		$ 1,426,000
Amortization and debt issue costs	$ 372,000	$ 378,000	$ 679,000	$ 797,000

- Definition

Amount, excluding unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Stockholders Deficit

6 Months Ended

Jun. 30, 2023

Stockholders' Equity (Deficit)

Stockholders Deficit

8. Stockholders’ Deficit

On January 7, 2022, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of shares of common stock authorized for issuance from 150,000,000 shares to 300,000,000 shares.

Reverse Stock Split

On April 10, 2023, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment, or the Certificate of Amendment, to the Company’s Amended and Restated Certificate of Incorporation, which became effective on April 10, 2023. The Certificate of Amendment implemented a 1-for-50 reverse stock split of the Company’s common stock. On the effective date of April 10, 2023, the number of the Company’s issued and outstanding shares of common stock was decreased from 46,605,134 to 932,101, and the par value remained unchanged. No fractional shares were issued as a result of the reverse stock split. Stockholders who would otherwise have been entitled to receive a fractional share received a cash payment in lieu thereof. The reverse stock split affected all shares of the Company’s common stock outstanding immediately prior to the effective date of the reverse stock split, as well as the number of shares of common stock available for issuance under the Company’s equity incentive plans. In addition, the reverse stock split effected a reduction in the number of shares of common stock issuable upon the exercise of stock options, restricted stock units, or warrants outstanding.

Shelf Registration Statement

On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices, and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

Public Offerings

In October 2021, the Company completed a public offering of 13,333 shares of its common stock and warrants to purchase 6,660 shares of its common stock at a combined price of $1,700 per share of common stock and one-half of a warrant to purchase one share of common stock. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $21.1 million.

In July, 2022, the Company completed a best efforts public offering (the “2022 Offering”) in which the Company raised net proceeds of $22.0 million through the sale of 382,966 shares of common stock and 150,366 pre-funded warrants (“Series B pre-funded warrants”) to purchase 150,366 shares of common stock at a combined price of $45.00 per share of common stock and warrants. Both the sales of shares of common stock and pre-funded warrants were accompanied by Series A-1 and Series A-2 warrants (together the “Series A warrants”) to purchase shares of common stock. The Series A-1 warrants are exercisable immediately and will expire five years from the

date of issuance, and the Series A-2 warrants are exercisable immediately and will expire thirteen months from the date of issuance. H.C. Wainwright acted as the exclusive placement agent in connection with the 2022 Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the 2022 Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 26,666 shares of common stock with an exercise price of $56.25 per share.

In May 2023, the Company completed a best efforts public offering of an aggregate of 95,000 shares of common stock and 1,801,286 pre-funded warrants in lieu of shares of common stock and warrants to purchase a total of 3,792,572 shares of common stock at combined public offering price of $3.9551 per share. Proceeds from the public offering, net of underwriting discounts, commissions, and offering expenses were approximately $6.5 million. Through June 30, 2023 at total of 508,286 pre-funded warrants have been exercised and 1,293,000 pre-funded warrants remain available for exercise as of June 30, 2023. H.C. Wainwright acted as the exclusive placement agent in connection with the Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 94,814 shares of commons stock with an exercise price of $4.9439 per share.

The Company has accounted for the warrants as liabilities, while the pre-funded warrants are classified as a component of permanent equity within additional paid-in capital because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The Company also determined that the pre-funded warrants should be included in the determination of basic earnings per share in accordance with ASC 260, Earnings per Share.

ATM Sales Agreement

In March 2021, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $50.0 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the year ended December 31, 2021, the Company issued and sold 3,457 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $9.3 million.

On January 10, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering an at-the-market offering program (the “2022 ATM”) the Company entered into for the sale of up to $50.0 million of shares of its common stock. The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the three months ended March 31, 2022, the Company issued and sold 512 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $0.3 million. On April 26, 2022, the Company terminated the 2022 ATM.

On April 27, 2022, the Company entered into a new at-the-market offering program (the “April 2022 ATM Agreement”) with H.C. Wainwright LLC and Co. (the “Sales Agent”) under which the Company is authorized to sell up to an aggregate of $12.8 million in gross proceeds through the sale of shares of common stock from time to time. The Company agreed to pay a commission of up to 3.0% of the gross proceeds of any common stock sold under the April 2022 ATM Agreement. Through September 30, 2022, the Company issued and sold a total of 173,750 shares of common stock under the April 2022 ATM Agreement, representing the entire capacity of the April 2022 ATM, resulting in net proceeds of approximately $12.2 million. On August 22, 2022, the Company increased the April 2022 ATM (“August 2022 ATM”). As increased, the Company was eligible to offer and sell, from time to time through the Sales Agent, shares of its common stock having an aggregate offering price of up to $75.0 million. During the year ended December 31, 2022, the Company issued and sold 78,852 shares of common stock under the August 2022 ATM resulting in net proceeds of approximately $0.9 million. During the six months ended June 30, 2023, the Company issued and sold 178,041 shares for net proceeds of approximately $1.7 million. On April 12, 2023, the Company filed a prospectus supplement to its registration statement on Form S-3 for the August 2022 ATM verifying that it is now eligible to sell up to $4.5 million worth of shares through its ATM.

Registered Direct Offering

On March 14, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering a direct offering (the “2022 Preferred Stock Offering”) of 2,425 shares of Series A convertible preferred stock (the “Series A Preferred Stock”) and 2,425 shares of Series B convertible preferred stock (the “Series B Preferred Stock”) and Series A warrants (the “Series A Warrants”) to purchase up to an aggregate of 12,125 shares of the common stock of the Company and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 12,125 shares of common stock. Each share of Series A Preferred Stock and Series B Preferred Stock has a stated value of $1,000 per share and a conversion price of $400.00 per share. The shares of preferred stock issued in the 2022 Preferred Stock Offering are convertible into an aggregate of 12,125 shares of common stock. The Series A Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The Series B Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire one and one-half years following the initial exercise date. Proceeds from the 2022 Preferred Stock Offering, net of the placement agent’s fees and offering expenses were approximately $4.1 million. A portion of the placement’s agents fees included warrants to purchase 606 shares of the common stock of the Company at a strike price of $500.00 per share. The warrants become exercisable six months following the date of issuance and will expire 5 years following the commencement of sales in the 2022 Preferred Stock Offering.

On March 15, 2022, 2,425 shares of the Series A Preferred Stock were converted into 6,025 shares of the Company’s common stock. On April 4, 2022, 2,425 shares of the Series B Preferred Stock were converted into 6,025 shares of the Company’s common stock.

On April 25, 2022, the Company entered into a letter agreement and waiver (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), pursuant to which Armistice consented to the Company entering into and effecting an at-the-market (“ATM”) offering facility. On March 14, 2022, the Company entered into the 2022 Preferred Stock Offering with Armistice, under which agreement, the Company was restricted from entering into and effecting an ATM offering facility until the 180-day anniversary of the Closing Date. Pursuant to the Letter Agreement, the Company issued to Armistice a new common stock purchase warrant (“New Warrant”), on the same terms and conditions as the Series A Warrants, provided that such New Warrant shall be exercisable into 4,243 warrant shares. The Series A Warrants have an exercise price of $520 per share and will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The New Warrant is exercisable 6 months after the date of the Letter Agreement.

Stock-Based Compensation Expense

Stock-based compensation expense was allocated as follows (in thousands):


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Cost of goods sold	$	28	$	31	$	57	$	75
Research and development		81		91		168		194
Selling and marketing		32		40		62		80
General and administrative		341		507		692		1,084
Total	$	482	$	669	$	979	$	1,433

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

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-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-Section 50
-Paragraph 13
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-Section S99
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-Subparagraph (SX 210.3-04)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stockholders Deficit - Amended and Restated Certificate of Incorporation (Details)	Apr. 10, 2023 shares	Jun. 30, 2023 shares	Apr. 09, 2023 shares	Dec. 31, 2022 shares	Jan. 07, 2022 shares	Jan. 06, 2022 shares
Stockholders' Equity (Deficit)
Common stock, authorized (in shares)		300,000,000		300,000,000	300,000,000	150,000,000
Reverse stock split conversion ratio	0.02
Common Stock, Shares, Outstanding	932,101	1,640,805	46,605,134	859,402

Fair Value Measurements - Warrant Valuation Assumptions (Details) - Option pricing model	Jun. 30, 2023 USD ($) Y	Dec. 31, 2022 USD ($) Y
Fair value
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	2.95	11.50
Preferred Warrants [Member] \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		520.00
Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	3.69
Maximum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	132.15	137.4
Maximum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	5.4	4.7
Maximum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	4.9	4.5
Maximum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	1,700.00	1,700
Minimum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	53.8	136.8
Minimum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	4.13	4.2
Minimum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	0.1	0.7
Minimum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	45.00	45.00

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2023

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The Company’s complete listing of significant accounting policies is described in Note 2 to the Company’s audited financial statements as of December 31, 2022 included in its Annual Report on Form 10-K filed with the SEC on March 23, 2023.

Use of Estimates

Risks and Uncertainties

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Fair Value of Financial Instruments

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Long-Lived Assets

Research and Development Expenses

Advertising Costs

Deferred Financing Costs

Concentrations of Credit Risk

Revenue Recognition

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows:

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Income Taxes

Stock-Based Compensation

Net Loss Per Share


	June 30,
	2023	2022
Common stock warrants	5,017,410	36,691
Unvested restricted stock units	135,047	142
Common stock options	43,510	5,778
Total	5,195,967	42,611

Recent Accounting Pronouncements

The Company did not adopt any new accounting pronouncements during the six months ended June 30, 2023 that had a material effect on its financial statements.

Prepaid Expenses and Other Current Assets (Tables)

6 Months Ended

Jun. 30, 2023

Prepaid Expenses

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following (in thousands):


	June 30,		December 31,
	2023		2022
Prepaid insurance	$	968	$	628
Other		898		775
Total prepaid expenses and other current assets	$	1,866	$	1,403

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Level 1
Assets:
Cash and cash equivalents	$ 2,785	$ 5,246
Total assets at fair value	2,785	5,246
Level 3
Liabilities:
Warrant Liability	9,095	5,934
Total liabilities at fair value	$ 9,095	$ 5,934

Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2023

Summary of Significant Accounting Policies

Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share


	June 30,
	2023	2022
Common stock warrants	5,017,410	36,691
Unvested restricted stock units	135,047	142
Common stock options	43,510	5,778
Total	5,195,967	42,611

Organization and Description of Business (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Nature of Operations
Accumulated deficit	$ 417,900	$ 408,702
Cash, cash equivalents and marketable securities	2,800
Working capital deficit	$ 3,700

Statements of Changes in Stockholders' Deficit - USD ($)	Preferred Stock Series B Convertible Preferred Stock	Preferred Stock Series A and B Convertible Preferred Stock	Preferred Stock	Common stock Public offering	Common stock At-the-market sales	Common stock Series A Convertible Preferred Stock	Common stock Series B Convertible Preferred Stock	Common stock	Additional Paid-in Capital. At-the-market sales	Additional Paid-in Capital.	Accumulated Deficit	At-the-market sales	Total
Balance at Dec. 31, 2021										$ 387,205,000	$ (383,290,000)		$ 3,915,000
Balance (in shares) at Dec. 31, 2021								60,698,000
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										764,000			764,000
Issuance of common stock									$ 348,000			$ 348,000
Issuance of common stock (in shares)					512,000
Issuance of common stock upon exercise of options (in shares)		4,850
Conversion of convertible preferred stock (in shares)						6,063,000
Vesting of RSUs			$ (2,425)
Vesting of RSUs (in shares)								35,000
Net loss											(10,385,000)		(10,385,000)
Balance at Mar. 31, 2022										388,317,000	(393,675,000)		(5,358,000)
Balance (in shares) at Mar. 31, 2022			2,425					67,308,000
Balance at Dec. 31, 2021										387,205,000	(383,290,000)		3,915,000
Balance (in shares) at Dec. 31, 2021								60,698,000
Increase (decrease) in stockholders' equity
Net loss													(15,553,000)
Balance at Jun. 30, 2022										401,212,000	(398,843,000)		2,369,000
Balance (in shares) at Jun. 30, 2022								247,202,000
Balance at Dec. 31, 2021										387,205,000	(383,290,000)		3,915,000
Balance (in shares) at Dec. 31, 2021								60,698,000
Balance at Dec. 31, 2022										403,157,000	(408,702,000)		(5,545,000)
Balance (in shares) at Dec. 31, 2022								859,402
Balance at Mar. 31, 2022										388,317,000	(393,675,000)		(5,358,000)
Balance (in shares) at Mar. 31, 2022			2,425					67,308,000
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										669,000			669,000
Issuance of common stock									12,226,000			12,226,000
Issuance of common stock (in shares)					173,750,000
Conversion of convertible preferred stock (in shares)	(2,425)						6,062,000
Vesting of RSUs (in shares)								82,000
Net loss											(5,168,000)		(5,168,000)
Balance at Jun. 30, 2022										401,212,000	(398,843,000)		2,369,000
Balance (in shares) at Jun. 30, 2022								247,202,000
Balance at Dec. 31, 2022										403,157,000	(408,702,000)		(5,545,000)
Balance (in shares) at Dec. 31, 2022								859,402
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										498,000			498,000
Issuance of common stock									1,003,000			1,003,000
Issuance of common stock (in shares)					72,699
Net loss											(5,389,000)		(5,389,000)
Balance at Mar. 31, 2023										404,658,000	(414,091,000)		(9,433,000)
Balance (in shares) at Mar. 31, 2023								932,101
Balance at Dec. 31, 2022										403,157,000	(408,702,000)		(5,545,000)
Balance (in shares) at Dec. 31, 2022								859,402
Increase (decrease) in stockholders' equity
Net loss													(9,197,000)
Balance at Jun. 30, 2023										405,779,000	(417,900,000)		(12,121,000)
Balance (in shares) at Jun. 30, 2023								1,640,805
Balance at Mar. 31, 2023										404,658,000	(414,091,000)		(9,433,000)
Balance (in shares) at Mar. 31, 2023								932,101
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										$ 482,000			$ 482,000
Fractional shares retired as a result of reverse split										13,000			13,000
Issuance of common stock									$ 652,000			$ 652,000
Issuance of common stock (in shares)				95,000	105,342
Exercise of pre-funded warrants (in shares)								508,286
Vesting of RSUs (in shares)								76
Net loss											(3,809,000)		$ (3,809,000)
Balance at Jun. 30, 2023										$ 405,779,000	$ (417,900,000)		$ (12,121,000)
Balance (in shares) at Jun. 30, 2023								1,640,805

Stockholders Deficit (Tables)

6 Months Ended

Jun. 30, 2023

Stockholders' Equity (Deficit)

Schedule of allocation of stock-based compensation expense

Stock-based compensation expense was allocated as follows (in thousands):


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Cost of goods sold	$	28	$	31	$	57	$	75
Research and development		81		91		168		194
Selling and marketing		32		40		62		80
General and administrative		341		507		692		1,084
Total	$	482	$	669	$	979	$	1,433

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2023	Aug. 07, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-36464
Entity Registrant Name	AGILE THERAPEUTICS INC
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	23-2936302
Entity Address, Address Line One	500 College Road East, Suite 300
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	609
Local Phone Number	683-1880
Title of 12(b) Security	Common stock
Trading Symbol	AGRX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		1,926,510
Entity Central Index Key	0001261249
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false

Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, authorized (in shares)	10,000,000	10,000,000
Preferred stock, issued (in shares)	4,850	0
Preferred stock, outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, authorized (in shares)	300,000,000	300,000,000
Common stock, issued (in shares)	1,640,805	859,402
Common stock, outstanding (in shares)	1,640,805	859,402

Summary of Significant Accounting Policies - Income Taxes (Details)	Jun. 30, 2023 USD ($)
Uncertainty in tax positions
Uncertain tax positions	$ 0

Commitments and Contingencies (Details) - USD ($) $ in Millions	1 Months Ended
	Apr. 30, 2023	Jun. 30, 2023
Commitments and Contingencies
Future purchase commitments		$ 232.4
Corium Agreement [Member]
Commitments and Contingencies
Quarterly minimum volume amount of product to be ordered	$ 5.6
Additional fee payable as a percentage of transfer price for units ordered	(25.00%)
Percentage of additional fee as penalty percent	25.00%
Reminder 2023		7.0
2024 and Each Year Thereafter		$ 22.5

Commitments and Contingencies

6 Months Ended

Jun. 30, 2023

Commitments and Contingencies

Commitments and Contingencies

10. Commitments and Contingencies

The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2033, total $232.4 million. This amount does not represent all of the Company’s anticipated purchases in the future, but instead represents only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend in 2023 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment.

In April 2020, the Company entered into a manufacturing and commercialization agreement with Corium (the “Corium Agreement”). Under the Corium Agreement, the Company has a requirement to order quarterly minimum volumes of approximately $5.6 million of product. In the event that the Company does not order the minimum volume, the Company is required to pay an additional fee equal to twenty-five percent (25%) per unit of the transfer price for all units ordered in that quarter. The Company did not meet the minimum volume order in the first or second quarter of 2022, and has, therefore, paid the additional 25% per unit fee as a penalty for all units ordered during the period. Based on current demand expectations for Twirla, the Company did not expect to meet the minimum volume order for the balance of 2022 and would be subject to the additional fee on future purchases. On July 25, 2022 the Company and Corium entered into Amendment No. 1 to the Corium Agreement (the “Amendment”) that is designed to restructure the contract minimums applicable to the purchase of manufactured Twirla and other services provided by Corium, transfer equipment ownership to Corium to support the manufacture of Twirla, and extend the term of the Corium Agreement. Pursuant to the Amendment, the parties agreed to adjust the process for the Company providing Corium certain binding and non-binding forecasts required under the Corium Agreement. Additionally, Corium will not enforce the original quantity minimums in the Corium Agreement, which are waived and replaced by new minimums that are based on Corium’s revenue for product purchased by the Company, expiring raw materials, and other services billed by Corium to support batch production and release. The guaranteed minimum revenue requirement for 2023 is $7.0 million, and is $22.5 million for 2024 and each year thereafter. In the event that the Company does not meet the guaranteed minimum revenue requirements in any given year, the Company will be required to make additional payments to Corium for the shortfall. The Company agreed to make certain monthly supplemental payments to Corium through December 2023, which payments are eligible to be retroactively reduced based upon product orders placed by the Company during 2023 meeting certain designated thresholds. In connection with the supplemental payments, Corium will retain the proceeds for the sale of certain raw materials to which the Company would otherwise have economic right to offset such supplemental payments. Further, the Company agreed to reimburse Corium for any unused raw materials in the event the Company’s actual product requirements are lower than initially forecasted. Pursuant to the Amendment, the term of the Corium Agreement was extended to December 31, 2033. Pursuant to the Amendment, the parties agreed to transfer ownership of certain manufacturing equipment used in the manufacture of Twirla from the Company to Corium under a Bill of Sale dated July 25, 2022.

The Company records a provision for contingent losses when it is both probable that a liability has been incurred, and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company's operations or its financial position. As of June 30, 2023, the Company has not recorded a provision for any contingent losses.