0001494650-22-000116 | 10-Q | XBRL Viewer

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Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2022	Oct. 31, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
Document Transition Report	false
Entity File Number	001-38241
Entity Registrant Name	OPTINOSE, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	42-1771610
Entity Address, Address Line One	1020 Stony Hill Road
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Yardley
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19067
City Area Code	267
Local Phone Number	364-3500
Title of 12(b) Security	Common stock, par value $0.001 per share
Trading Symbol	OPTN
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	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		83,520,471
Entity Central Index Key	0001494650
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Amendment Flag	false

Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 61,080	$ 110,502
Accounts receivable, net	26,616	35,449
Inventory	10,415	11,847
Prepaid expenses and other current assets	2,820	2,581
Total current assets	100,931	160,379
Property and equipment, net	901	1,347
Other assets	3,438	4,345
Total assets	105,270	166,071
Current liabilities:
Accounts payable	8,403	8,013
Accrued expenses and other current liabilities	41,285	51,222
Short term debt, net	128,107	0
Total current liabilities	177,795	59,235
Long-term debt, net	0	126,418
Other liabilities	891	2,190
Total liabilities	178,686	187,843
Stockholders' deficit:
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 83,520,471 and 82,238,900 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	84	82
Additional paid-in capital	596,329	588,288
Accumulated deficit	(669,745)	(610,061)
Accumulated other comprehensive loss	(84)	(81)
Total stockholders' deficit	(73,416)	(21,772)
Total liabilities and stockholders' deficit	$ 105,270	$ 166,071

Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value (usd per share)	$ 0.001	$ 0.001
Shares authorized (in shares)	200,000,000	200,000,000
Shares issued (in shares)	83,520,471	82,238,900
Shares outstanding (in shares)	83,520,471	82,238,900

Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Total revenues	$ 20,078	$ 21,826	$ 55,420	$ 52,143
Costs and expenses:
Cost of product sales	2,125	2,411	6,282	6,576
Research and development	3,267	6,654	12,339	20,058
Selling, general and administrative	25,486	25,801	84,339	80,293
Total operating expenses	30,878	34,866	102,960	106,927
Loss from operations	(10,800)	(13,040)	(47,540)	(54,784)
Other (income) expense:
Interest income	(48)	(9)	(218)	(42)
Interest expense	4,207	4,072	12,365	11,959
Foreign currency (gains) losses	(5)	14	(3)	38
Gain on sale of equipment	0	0	0	(67)
Net loss	$ (14,954)	$ (17,117)	$ (59,684)	$ (66,672)
Net loss per share of common stock, basic (in USD per share)	$ (0.18)	$ (0.32)	$ (0.72)	$ (1.25)
Net loss per share of common stock, diluted (in USD per share)	$ (0.18)	$ (0.32)	$ (0.72)	$ (1.25)
Weighted average common shares outstanding, basic (in shares)	83,320,704	53,334,669	82,846,868	53,151,730
Weighted average common shares outstanding, diluted (in shares)	83,320,704	53,334,669	82,846,868	53,151,730
Net product revenues
Total revenues	$ 20,078	$ 21,826	$ 55,420	$ 51,143
Licensing revenues
Total revenues	$ 0	$ 0	$ 0	$ 1,000

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Statement of Comprehensive Income [Abstract]
Net loss	$ (14,954)	$ (17,117)	$ (59,684)	$ (66,672)
Other comprehensive loss:
Foreign currency translation adjustment	0	2	(3)	4
Comprehensive loss	$ (14,954)	$ (17,115)	$ (59,687)	$ (66,668)

- Definition

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

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+ Details

Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Accumulated Other Comprehensive Loss
Beginning balance (in shares) at Dec. 31, 2020		52,945,865
Beginning balance at Dec. 31, 2020	$ 6,788	$ 53	$ 534,585	$ (527,765)	$ (85)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	2,596		2,596
Vesting of restricted stock units and exercise of options (in shares)		166,709
Vesting of restricted stock units and exercise of options	0
Foreign currency translation adjustment	2				2
Net loss	(26,053)			(26,053)
Ending balance (in shares) at Mar. 31, 2021		53,112,574
Ending balance at Mar. 31, 2021	(16,667)	$ 53	537,181	(553,818)	(83)
Beginning balance (in shares) at Dec. 31, 2020		52,945,865
Beginning balance at Dec. 31, 2020	6,788	$ 53	534,585	(527,765)	(85)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(66,672)
Ending balance (in shares) at Sep. 30, 2021		53,449,567
Ending balance at Sep. 30, 2021	(51,469)	$ 53	542,996	(594,437)	(81)
Beginning balance (in shares) at Mar. 31, 2021		53,112,574
Beginning balance at Mar. 31, 2021	(16,667)	$ 53	537,181	(553,818)	(83)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	2,729		2,729
Vesting of restricted stock units and exercise of options (in shares)		37,034
Vesting of restricted stock units and exercise of options	0
Issuance of common stock under employee stock purchase plan (in shares)		135,525
Issuance of common stock under employee stock purchase plan	367		367
Foreign currency translation adjustment	0
Net loss	(23,502)			(23,502)
Ending balance (in shares) at Jun. 30, 2021		53,285,133
Ending balance at Jun. 30, 2021	(37,073)	$ 53	540,277	(577,320)	(83)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	2,680		2,680
Vesting of restricted stock units and exercise of options (in shares)		140,555
Vesting of restricted stock units and exercise of options	0
Exercise of common stock options (in shares)		23,879
Exercise of common stock options	39		39
Foreign currency translation adjustment	2				2
Net loss	(17,117)			(17,117)
Ending balance (in shares) at Sep. 30, 2021		53,449,567
Ending balance at Sep. 30, 2021	(51,469)	$ 53	542,996	(594,437)	(81)
Beginning balance (in shares) at Dec. 31, 2021		82,238,900
Beginning balance at Dec. 31, 2021	(21,772)	$ 82	588,288	(610,061)	(81)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	1,998		1,998
Vesting of restricted stock units and exercise of options (in shares)		262,942
Vesting of restricted stock units and exercise of options	0
Issuance of common stock under employee stock purchase plan (in shares)		179,206
Issuance of common stock under employee stock purchase plan	250	$ 1	249
Foreign currency translation adjustment	(1)				(1)
Net loss	(25,333)			(25,333)
Ending balance (in shares) at Mar. 31, 2022		82,681,048
Ending balance at Mar. 31, 2022	(44,858)	$ 83	590,535	(635,394)	(82)
Beginning balance (in shares) at Dec. 31, 2021		82,238,900
Beginning balance at Dec. 31, 2021	(21,772)	$ 82	588,288	(610,061)	(81)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(59,684)
Ending balance (in shares) at Sep. 30, 2022		83,520,471
Ending balance at Sep. 30, 2022	(73,416)	$ 84	596,329	(669,745)	(84)
Beginning balance (in shares) at Mar. 31, 2022		82,681,048
Beginning balance at Mar. 31, 2022	(44,858)	$ 83	590,535	(635,394)	(82)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	3,474		3,474
Vesting of restricted stock units and exercise of options (in shares)		363,318
Vesting of restricted stock units and exercise of options	0
Foreign currency translation adjustment	(2)				(2)
Net loss	(19,397)			(19,397)
Ending balance (in shares) at Jun. 30, 2022		83,044,366
Ending balance at Jun. 30, 2022	(60,783)	$ 83	594,009	(654,791)	(84)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	1,917		1,917
Vesting of restricted stock units and exercise of options (in shares)		267,967
Vesting of restricted stock units and exercise of options	98		98
Issuance of common stock under employee stock purchase plan (in shares)		208,138
Issuance of common stock under employee stock purchase plan	306	$ 1	305
Foreign currency translation adjustment	0
Net loss	(14,954)			(14,954)
Ending balance (in shares) at Sep. 30, 2022		83,520,471
Ending balance at Sep. 30, 2022	$ (73,416)	$ 84	$ 596,329	$ (669,745)	$ (84)

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Operating activities:
Net loss	$ (59,684)	$ (66,672)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization	400	478
Stock-based compensation	7,391	8,027
Amortization of debt discount and issuance costs	1,689	1,364
Gain on sale of property and equipment	0	(67)
Changes in operating assets and liabilities:
Accounts receivable	8,833	(695)
Prepaid expenses and other assets	1,215	1,416
Inventory	1,524	(4,049)
Accounts payable	395	1,188
Accrued expenses and other liabilities	(11,734)	(1,209)
Cash used in operating activities	(49,971)	(60,219)
Investing activities:
Purchases of property and equipment	(60)	(143)
Proceeds from sale of property and equipment	0	105
Cash used in investing activities	(60)	(38)
Financing activities:
Proceeds from the exercise of stock options	93	39
Proceeds from issuance of common stock under employee stock purchase plan	556	367
Cash paid for financing costs	0	(95)
Cash provided by financing activities	649	311
Effects of exchange rate changes on cash and cash equivalents	(12)	2
Net decrease in cash, cash equivalents and restricted cash	(49,394)	(59,944)
Cash, cash equivalents and restricted cash at beginning of period	110,515	144,179
Cash, cash equivalents and restricted cash at end of period	61,121	84,235
Supplemental disclosure of noncash activities:
Fixed asset purchases within accounts payable and accrued expenses	4	23
Recognition of right-of-use assets	508	157
Recognition of lease liabilities	$ 508	$ 157

Organization and Description of Business	9 Months Ended
Organization and Description of Business	Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Description of Business	Organization and Description of Business OptiNose, Inc. (the Company) was incorporated in Delaware in May 2010 (inception) and has facilities in Yardley, Pennsylvania, Ewing, New Jersey, and Oslo, Norway. The Company's predecessor entity, OptiNose AS, was formed under the laws of Norway in September 2000. In 2010, OptiNose AS became a wholly-owned subsidiary of the Company as part of an internal reorganization. During 2022, the Company’s board of directors approved the liquidation of Optinose AS and Optinose UK in order to simplify corporate structure. The Company is a specialty pharmaceutical company focused on the development and commercialization of products for patients treated by ear, nose and throat (ENT) and allergy specialists. The Company's first commercial product, XHANCE® (fluticasone propionate) nasal spray, 93 mcg, is a therapeutic utilizing its proprietary Exhalation Delivery System (EDS) that delivers a topically-acting corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps and, if approved, chronic rhinosinusitis without nasal polyps (also referred to as chronic sinusitis). XHANCE was approved by the United States (US) Food and Drug Administration (FDA) in September 2017 for the treatment of nasal polyps in patients 18 years of age or older. XHANCE was made widely available through commercial channels in April 2018.

Liquidity	9 Months Ended
Liquidity	Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Liquidity	Liquidity Since inception, the Company's operations have focused on organization and staffing, business planning, raising capital, establishing an intellectual property portfolio, conducting preclinical studies and clinical trials, pursuing regulatory approvals and most recently, commercializing XHANCE in the US. As of September 30, 2022, the Company had cash and cash equivalents of $61,080. For the nine months ended September 30, 2022, the Company had a net loss of $59,684 and negative cash from operations of $49,971. As of September 30, 2022, the Company had an accumulated deficit of $669,745. The Company is subject to a number of risks similar to other life sciences companies, including, but not limited to, successful discovery, development and commercialization of its products and product candidates, raising additional capital, the development by its competitors of new technological innovations, protection of proprietary technology and market acceptance of the Company's products. The Company's continuation as a going concern is dependent on its ability to continue to maintain compliance with its covenants under that certain Note Purchase Agreement, dated as of September 12, 2019, as amended pursuant to that certain letter agreement dated as of August 13, 2020 and as further amended by certain amendments to the Note Purchase Agreement dated as of March 2, 2021, November 16, 2021, August 10, 2022 and November 9, 2022 (the Note Purchase Agreement) that the Company entered into with funds managed by Pharmakon Advisors, LP (Pharmakon), the investment manager of the BioPharma Credit Funds (BioPharma), including the minimum trailing twelve-month consolidated XHANCE net sales and royalties the Company is required to achieve each quarter and its ability to generate sufficient cash flows from operations to meet its obligations and/or obtain additional capital through equity or debt financings, partnerships, collaborations, or other sources, as may be required. The Note Purchase Agreement includes events of default, in certain cases subject to customary periods to cure, following which Pharmakon may accelerate all amounts outstanding under the senior secured notes issued pursuant to the Note Purchase Agreement (Pharmakon Senior Secured Notes). The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. On November 9, 2022, the Company entered into a Fourth Amendment to the Note Purchase Agreement (the Fourth Amendment). The Fourth Amendment provided a waiver of the minimum consolidated XHANCE net sales and royalties required to be achieved under the Note Purchase Agreement for the trailing twelve-month period ending September 30, 2022 and December 31, 2022 in exchange for a $1,300 fee due on the repayment of the Pharmakon Senior Secured Notes. The Company believes it is probable that it will not achieve the trailing twelve-month minimum consolidated XHANCE net sales and royalties thresholds that it is required to achieve under the Note Purchase Agreement for the periods ending March 31, 2023, June 30, 2023 and September 30, 2023, which will constitute a default under the Note Purchase Agreement if the Company is unable to obtain a modification or waiver of such minimum consolidated XHANCE net sales and royalties thresholds. In addition, the Note Purchase Agreement contains financial covenants requiring the Company to maintain at all times a minimum of $30,000 of cash and cash equivalents. If the Company is unable to obtain additional capital or obtain a waiver or modification to this liquidity covenant, the Company believes that it is probable that it will not be able to maintain at least $30,000 of cash and cash equivalents for at least twelve-months following the filing of this Form 10-Q, which will constitute a default of the liquidity financial covenant under the Note Purchase Agreement. In the event of any one of the foregoing defaults, the holders of the Pharmakon Senior Secured Notes may declare an Event of Default under Note Purchase Agreement and may elect to accelerate the repayment of all unpaid principal, accrued interest and other amounts due under such holders’ Pharmakon Senior Secured Notes, which may require the Company to delay or curtail its operations until additional funding is received. These factors raise substantial doubt about the Company's ability to continue as a going concern. The terms of the Note Purchase Agreement and the Pharmakon Senior Secured Notes, including applicable covenants, are described in Note 8. Additionally, the Company will likely require additional capital in the future secured through equity or debt financings, partnerships, collaborations, or other sources in order to meet its debt service obligations, including repayment, under the Pharmakon Senior Secured Notes, and to carry out the Company's planned development and commercial activities. If additional capital is not obtained when required, the Company may need to delay or curtail its operations until additional funding is received.

Basis of Presentation and Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Basis of Presentation and Summary of Significant Accounting Policies

The accompanying unaudited interim consolidated financial statements have been prepared in conformity with US generally accepted accounting principles (GAAP). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).

In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the financial statements) considered necessary to present fairly the Company's financial position as of September 30, 2022 and its results of operations for the three and nine months ended September 30, 2022 and 2021 and cash flows for the nine months ended September 30, 2022 and 2021. Operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. The unaudited interim financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. The accompanying unaudited interim financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2021 contained in the Company’s annual report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 8, 2022.

Use of estimates

The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim consolidated financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary.

Concentration of credit risk

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and accounts receivable. The Company generally invests its cash in deposits with high credit quality financial

institutions. Additionally, the Company performs periodic evaluations of the relative credit standing of these financial institutions.

Customer and supplier concentration

The Company has exposure to credit risk in accounts receivable from sales of product. XHANCE is sold to wholesale pharmaceutical distributors and preferred pharmacy network (PPN) partners, who, in turn, sell XHANCE to pharmacies, hospitals and other customers. Five customers represented approximately 40% of the Company's accounts receivable at September 30, 2022 and five customers represented approximately 31% and 29% of the Company's net product sales for the three and nine months ended September 30, 2022.

The Company purchases XHANCE and its components from several third-party suppliers and manufacturing partners, certain of which are available through a single source. Although the Company could obtain each of these components from alternative third-party suppliers, it would need to qualify and obtain FDA approval for another supplier as a source for each such component. The Company has initiated the process of qualifying an alternate third-party supplier for select components of XHANCE. Alternate third party suppliers of XHANCE components are subject to qualification and approval from the FDA.

Fair value of financial instruments

At September 30, 2022 and December 31, 2021, the Company's financial instruments included cash and cash equivalents, accounts receivable, grants receivable, accounts payable and accrued expenses. The carrying amounts reported in the Company's financial statements for these instruments approximate their respective fair values because of the short-term nature of these instruments. In addition, the Company believes that at September 30, 2022, the carrying value of long-term debt approximated fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. At September 30, 2022 and December 31, 2021, there were no financial assets or liabilities measured at fair value on a recurring basis.

Restricted cash

As of September 30, 2022 and December 31, 2021, the restricted cash balance included in prepaid expenses and other assets was $41 and $13, respectively.

Net product revenues

The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted on January 1, 2018. The Company recognizes revenue from XHANCE sales at the point customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration. The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. The components of the Company’s variable consideration include the following:

Provider Chargebacks and Discounts. Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable.

Trade Discounts and Allowances. The Company generally provides customers with discounts that include incentive fees which are explicitly stated in the Company’s contracts. These discounts are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized.

Product Returns. Consistent with industry practice, the Company has a product returns policy that provides customers a right of return for product purchased within a specified period prior to and subsequent to the product’s

expiration date. The Company estimates the amount of its product that may be returned and presents this amount as a reduction of revenue in the period the related product revenue is recognized, in addition to establishing a liability. The Company considers several factors in the estimation process, including expiration dates of product shipped to customers, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors.

Government Rebates. The Company is subject to discount obligations under state Medicaid programs and Medicare. Reserves related to these discount obligations are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel inventories at the end of the reporting period.

Payor Rebates. The Company contracts with certain third-party payors, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the plan or the organization with which it contracts. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

Patient Assistance. Other programs that the Company offers include voluntary co-pay patient assistance programs intended to provide financial assistance to eligible patients with prescription drug co-payments required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period.

Distribution and Other Fees. The Company pays distribution and other fees to certain customers in connection with the sales of its products. The Company records distribution and other fees paid to its customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and the Company can reasonably estimate the fair value of the goods or services received. If both conditions are met, the Company records the consideration paid to the customer as an operating expense. These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale.

Licensing revenues

The Company has license agreements with Centessa Pharmaceuticals (Centessa) and Currax Pharmaceuticals LLC (Currax). These license agreements provide for exclusive licensed rights to certain intellectual property, a non-refundable up-front payment, potential milestone payment(s) and potential royalty payment(s). The Company analyzed the performance obligations under the license agreements, the consideration received to date and the consideration the Company could receive in the future as part of its analysis related to ASC 606. The Company is not eligible to receive any further payments under the Currax license agreement other than reimbursement for certain expenses. The Company does not expect to any receive license revenues under the Centessa agreement in the near term.

Net income (loss) per common share

Basic net income (loss) per common share is determined by dividing net income (loss) applicable to Company common stock (Common Stock) holders by the weighted average common shares outstanding during the period. For the three and nine months ended September 30, 2022 and 2021, the outstanding Common Stock options, Restricted Stock units, Common Stock warrants and shares to be issued under the Company's 2017 Employee Stock Purchase Plan have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, the weighted average shares used to calculate both basic and diluted net loss per share are the same.

Diluted net loss per common share for the periods presented do not reflect the following potential common shares, as the effect would be antidilutive:


	September 30,
	2022	2021
Stock options	9,581,947	7,928,817
Restricted stock units	1,871,021	2,013,934
Common stock warrants	2,500,000	810,357
Employee stock purchase plan	74,935	123,754
Total	14,027,903	10,876,862

Income taxes

In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes, the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and nine months ended September 30, 2022 and 2021, the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. As of September 30, 2022 and December 31, 2021, the Company concluded that a full valuation allowance would be necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest or penalties in the accompanying consolidated financial statements.

Inventory

9 Months Ended

Sep. 30, 2022

Inventory Disclosure [Abstract]

Inventory

InventoryInventory consisted of the following:


	September 30, 2022		December 31, 2021
Raw materials	$	1,894	$	3,504
Work-in-process	5,610		4,816
Finished goods	2,911		3,527
Total inventory	$	10,415	$	11,847

Inventories are stated at the lower of cost or net realizable value, as determined on a first-in, first-out, basis.

Property and Equipment

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment

Property and equipment, net, consisted of the following:


	September 30, 2022		December 31, 2021
Computer equipment and software	$	1,203	$	1,173
Furniture and fixtures	366		366
Machinery and equipment	3,061		3,367
Leasehold improvements	609		609
Construction in process	115		115
	5,354		5,630
Less: accumulated depreciation	(4,453)		(4,283)
	$	901	$	1,347

Depreciation expense was $144 and $153 for the three months ended September 30, 2022 and 2021, respectively. Depreciation expense was $399 and $476 for the nine months ended September 30, 2022 and 2021, respectively. In addition, depreciation expense of $667 and $17 was charged to inventory and prepaid expenses and other

assets, respectively, as of September 30, 2022, which represents depreciation expense related to equipment involved in the manufacturing process.

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current LiabilitiesAccrued expenses and other current liabilities consisted of:


	September 30, 2022		December 31, 2021
Accrued expenses:
Selling, general and administrative expenses	$	5,842	$	6,124
Research and development expenses	2,380		6,857
Payroll expenses	7,506		7,569
Product revenue allowances	21,018		26,521
Other	2,293		2,057
Total accrued expenses	39,039		49,128
Other current liabilities:
Lease liability	2,246		2,094
Total other current liabilities	2,246		2,094
Total accrued expenses and other current liabilities	$	41,285	$	51,222

Licensing Revenue	9 Months Ended
Licensing Revenue	Sep. 30, 2022
Research and Development [Abstract]
Licensing Revenue	Licensing Revenue Currax License Agreement On September 25, 2019, OptiNose AS entered into a license agreement (the Currax License Agreement) with Currax pursuant to which the Company granted Currax a license to certain intellectual property for the commercialization of Onzetra Xsail® in the US, Canada and Mexico. Under the terms of the Currax License Agreement, Currax paid the Company an upfront payment of $3,730, which was recognized as license revenue during the year ended December 31, 2019. On December 29, 2020, the Company received an additional $750 upon the expiration of the escrow that was established for a limited period to cover potential indemnification obligations. In addition, in January 2021 the Company received a $1,000 milestone payment in connection with the achievement of a specified regulatory milestone. The Company is no longer eligible to receive any further payments from Currax under the terms of the Currax License Agreement other than reimbursement for certain expenses.

Debt

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Debt

On September 12, 2019 (the Closing Date), the Company entered into a Note Purchase Agreement (the Note Purchase Agreement) with funds managed by Pharmakon Advisors, LP (Pharmakon), the investment manager of BioPharma Credit Funds (BioPharma). The Note Purchase Agreement provided the Company with $130,000 in debt financing, of which $80,000 of senior secured notes (the Pharmakon Senior Secured Notes) was issued on the Closing Date, $30,000 was issued on February 13, 2020 after achieving the $9,000 consolidated XHANCE net sales and royalties threshold for the quarter ended December 31, 2019 and $20,000 was issued on December 1, 2020 after achieving the $14,500 consolidated XHANCE net sales and royalties threshold for the quarter ended September 30, 2020.

On August 10, 2022, the Company entered into a Third Amendment to the Note Purchase Agreement (the Third Amendment). The Third Amendment reduced the minimum consolidated XHANCE net sales and royalties required to be achieved under the Note Purchase Agreement for the trailing twelve-month period ending December 31, 2022 from $90,000 to $85,000 in exchange for a $780 fee due on the repayment of the Pharmakon Senior Secured Notes.

On November 9, 2022, the Company entered into a Fourth Amendment to the Note Purchase Agreement (the Fourth Amendment). The Fourth Amendment resulted in the waiver of the minimum consolidated XHANCE net sales and royalties required to be achieved under the Note Purchase Agreement for the trailing twelve-month period ending September 30, 2022 and December 31, 2022 in exchange for a $1,300 fee due upon repayment of the Pharmakon Senior Secured Notes.

The Pharmakon Senior Secured Notes bear interest at a fixed rate of 10.75% per annum and are currently scheduled to mature on September 12, 2024 (the Maturity Date). Principal repayments will commence on September 15, 2023, with five equal quarterly installments of principal and interest through the Maturity Date.

The Company is required to repay the Pharmakon Senior Secured Notes in full upon the occurrence of a change of control (as defined in the Note Purchase Agreement). In addition, the Company may make voluntary prepayments in whole or in part. All mandatory and voluntary prepayments are subject to the payment of prepayment premiums as follows: (i) if prepayment occurs prior to the third anniversary of the Closing Date, an amount equal to 2% of the principal prepaid, (ii) if prepayment occurs on or after the third anniversary of the Closing Date but prior to the fourth anniversary of the Closing Date, an amount equal to 1% of the principal prepaid, and (iii) if prepayment occurs on or after the fourth anniversary of the Closing Date, no prepayment premium is required. The Company is also required to pay a "make-whole" amount in respect of any principal prepayments (whether mandatory or voluntary) made prior to the 30-month anniversary of the closing of the Company's underwritten public offering on November 18, 2021, in an amount equal to the interest that would have accrued through the 30-month anniversary in respect of such note but for such principal prepayment, provided that in the case of any prepayment made prior to the 15-month anniversary, the Company will not be required to pay a "make-whole" amount in excess of an amount equal to the interest that would have accrued through the 15-month anniversary but for such principal prepayment.

The Pharmakon Senior Secured Notes are secured by a pledge of substantially all of the assets of the Company and the Guarantors and the Note Purchase Agreement contains affirmative and negative covenants customary for financings of this type, including limitations on the Company’s and its subsidiaries’ ability, among other things, to incur additional debt, grant or permit additional liens, make investments and acquisitions, merge or consolidate with others, dispose of assets, pay dividends and distributions, repay junior indebtedness and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the Note Purchase Agreement contains financial covenants requiring the Company to maintain at all times certain minimum trailing twelve-month consolidated XHANCE net sales and royalties, tested on a quarterly basis, and at least $30,000 of cash and cash equivalents. The Note Purchase Agreement also includes events of default customary for financings of this type, in certain cases subject to customary periods to cure, following which BioPharma may accelerate all amounts outstanding under the Pharmakon Senior Secured Notes.

The Company believes that it is probable that it will not achieve the trailing twelve-month minimum consolidated XHANCE net sales and royalties thresholds that it is required to achieve for the periods ending March 31, 2023, June 30, 2023, and September 30, 2023. Additionally, without additional financing, the Company believes that it is probable that it will not be able to maintain at least $30,000 of cash and cash equivalents for at least twelve-months following the filing of this Form 10-Q. As a result, in accordance with FASB Accounting Standards Codification 470, the Company has classified all outstanding principal and the payment of additional fees upon maturity as a current liability in the accompanying consolidated balance sheet as of September 30, 2022.

The Company recorded interest expense of $4,207 and $4,072 during the three months ended September 30, 2022 and 2021, respectively, and $12,365 and $11,959 during the nine months ended September 30, 2022 and 2021, respectively. Interest expense included total coupon interest and the amortization of debt issuance costs.

The Pharmakon debt balance is comprised of the following:



	September 30, 2022		December 31, 2021
Face amount	$	130,000	$	130,000
Front end fees	(483)		(717)
Debt issuance costs	(3,490)		(4,165)
Back end fees	2,080		1,300
Debt, net	$	128,107	$	126,418

- 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.

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+ Details

Employee Benefit Plans	9 Months Ended
Employee Benefit Plans	Sep. 30, 2022
Retirement Benefits [Abstract]
Employee Benefit Plans	Employee Benefit Plans For US employees, the Company maintains a defined contribution 401(k) retirement plan. As of September 30, 2022, $125 was recorded in accrued liabilities related to the Company match. The Company's contributions are made in cash. For foreign employees, the Company maintains a defined contribution pension plan which meets the statutory requirements of the jurisdiction. The Company incurred costs related to the pension plan of $1 and $1 for the three months ended September 30, 2022 and 2021, respectively, and $4 and $5 for the nine months ended September 30, 2022 and 2021, respectively.

- Definition

The entire disclosure for retirement benefits.

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+ Details

Stockholders' Equity

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Stockholders' Equity

Common stock warrants

On November 18, 2021, in conjunction with the Second Amendment to the Note Purchase Agreement (the Second Amendment), the Company issued warrants to purchase an aggregate of 2,500,000 shares of Common Stock at an exercise price of $1.60 and fair value of $2,009. Upon execution of the Second Amendment, warrants previously issued of 810,357 at a share price of $6.72 which were set to expire on September 12, 2022, were cancelled.

As of September 30, 2022, the Company had the following warrants outstanding to purchase shares of Common Stock:

Number of Shares

Exercise Price Per Share

Expiration Date

2,500,000

$1.60

November 18, 2024

- 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

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+ Details

Stock-based Compensation

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Stock-based Compensation

The Company recorded stock-based compensation expense related to stock options and shares issued under the Company's 2010 Stock Incentive Plan and 2017 Employee Stock Purchase Plan (2017 Plan) in the following expense categories of its accompanying consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Cost of product sales	$	10	$	20	$	30	$	38
Research and development	219		298		648		865
General and administrative	1,721		2,366		6,716		7,124
	$	1,950	$	2,684	$	7,394	$	8,027

In addition, stock-based compensation expense of $82 and $1 was capitalized to inventory and prepaid expenses and other assets, respectively, as of September 30, 2022, which represents the stock-based compensation expense incurred related to employees involved in the manufacturing process of finished goods and samples.

Stock Options

The Company issues stock-based awards pursuant to its 2010 Stock Incentive Plan. Effective as of October 12, 2017, the Company's 2010 Stock Incentive Plan was amended and restated (A&R Plan).The Company has issued service-based, performance-based, and market-based stock options that generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Company's board of directors or committee thereof. Vesting generally occurs over a period of not greater than four years. Performance-based options may vest upon the achievement of certain milestones. As of September 30, 2022, all of the performance conditions related to performance-based stock options issued by the Company had been achieved. Market-based options may vest upon the achievement of certain market-based objectives relating to the trading price of the Company's Common Stock.

The following table summarizes the activity related to stock option grants to employees and non-employees for the nine months ended September 30, 2022:


	Shares	Weighted average exercise price per share		Weighted average remaining contractual life
Outstanding at December 31, 2021	7,958,781	$	8.87	6.50
Granted	2,932,370	1.90
Exercised	(95,000)	2.18
Expired	(639,288)	10.08
Forfeited	(574,916)	3.72
Outstanding at September 30, 2022	9,581,947	$	7.03	6.31
Exercisable at September 30, 2022	5,526,439	$	10.19	4.98
Vested and expected to vest at September 30, 2022	8,688,917	$	7.57	6.31

During the nine months ended September 30, 2022, stock options to purchase 2,932,370 shares of Common Stock were granted to employees and generally vest over four years. Included in the total stock options granted were market-based options to purchase 959,215 shares of Common Stock. The stock options, including the market-based options, had an estimated weighted average grant date fair value of $1.19. During the nine months ended September 30, 2021, stock options to purchase 1,615,696 shares of Common Stock were granted to employees

that generally vest over four years. The stock options had an estimated weighted average grant date fair value of $2.26.

The grant date fair value of each stock option grant, other than market-based stock option grants, was estimated at the time of grant using the Black-Scholes option-pricing model using the following weighted average assumptions:


	Nine Months Ended September 30,
	2022			2021
Risk free interest rate	1.84		%	1.00		%
Expected term (in years)	6.08			6.08
Expected volatility	72.69		%	74.18		%
Annual dividend yield	0.00		%	0.00		%
Fair value of common stock	$	1.92		$	3.48

At September 30, 2022, the unrecognized compensation cost related to unvested stock options, other than market-based stock options, expected to vest was $5,439. This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.17 years.

During the nine months ended September 30, 2022, market-based options to purchase 959,215 shares of Common Stock were granted to employees and generally become eligible to vest over four years, subject to the achievement of certain market-based objectives relating to the trading price of the Common Stock. Stock based compensation for these awards is recognized over the derived service period of approximately 2 years. The grant date fair value of each stock option grant, as well as the derived service period for these awards, was estimated at the time of grant using a Monte Carlo simulation based on the following assumptions:


	Nine Months Ended September 30,
	2022
Risk free rates of return	1.70	%
Expected volatility	75.00	%
Annual dividend yield	—	%

During the nine months ended September 30, 2022, 297,677 market-based options vested upon the achievement of certain market-based objectives relating to the trading price of the Company's Common Stock.

Restricted Stock Units

The Company has issued service-based and performance-based restricted stock units (RSUs). Vesting generally occurs over a period not greater than four years. Vesting of the performance-based RSUs is subject to the achievement of certain milestones in connection with the Company's development programs.

The following table summarizes the activity related to RSUs granted to employees for the nine months ended September 30, 2022:


			Shares
Outstanding at December 31, 2021			1,959,358
Granted			1,105,246
Vested and settled			(838,867)
Expired/forfeited/canceled			(354,716)
Outstanding at September 30, 2022			1,871,021
Expected to vest at September 30, 2022			1,871,021

During the nine months ended September 30, 2022, the Company granted 1,105,246 RSUs at a grant date fair value of $1.85, all of which were service-based RSUs. No performance-based RSUs were granted in 2022. As of September 30, 2022, one of the milestones associated with the previously granted performance based-RSUs was

achieved. As a result 248,830 RSUs vested on June 15, 2022. At September 30, 2022, the recognized compensation cost related to vested performance-based RSUs was $1,514. At September 30, 2022, the unrecognized compensation cost related to unvested service-based RSUs expected to vest was $4,214, to be recognized over an estimated weighted-average amortization period of 2.46 years. The unrecognized compensation cost related to unvested performance-based RSUs was $1,178, which will be recognized over the remaining service period.

Included in the table above are 60,000 RSUs granted outside the A&R Plan. The grants were made pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4).

2017 Employee Stock Purchase Plan

Under the 2017 Plan, shares of Common Stock may be purchased by eligible employees who elect to participate in the 2017 Plan at 85% of the lower of the fair market value of Common Stock on the first or last day of designated offering periods. The Company recognized stock-based compensation expense of $53 and $65 during the three months ended September 30, 2022 and 2021, respectively, and $215 and $264 during the nine months ended September 30, 2022 and 2021, respectively, related to the 2017 Plan.

The Company calculated the fair value of each option grant and the shares issued under the 2017 Plan on the respective dates of grant using the following weighted average assumptions:


	Nine Months Ended September 30,
	2022		2021
Risk free interest rate	0.17	%	0.07	%
Expected term (in years)	0.5		0.5
Expected volatility	88.13	%	65.43	%
Annual dividend yield	0.00	%	0.00	%

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Use of estimates	Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim consolidated financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary.
Concentration of credit risk and customer and supplier concentration	Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and accounts receivable. The Company generally invests its cash in deposits with high credit quality financial institutions. Additionally, the Company performs periodic evaluations of the relative credit standing of these financial institutions. Customer and supplier concentration The Company has exposure to credit risk in accounts receivable from sales of product. XHANCE is sold to wholesale pharmaceutical distributors and preferred pharmacy network (PPN) partners, who, in turn, sell XHANCE to pharmacies, hospitals and other customers.
Fair value of financial instruments	Fair value of financial instrumentsAt September 30, 2022 and December 31, 2021, the Company's financial instruments included cash and cash equivalents, accounts receivable, grants receivable, accounts payable and accrued expenses. The carrying amounts reported in the Company's financial statements for these instruments approximate their respective fair values because of the short-term nature of these instruments. In addition, the Company believes that at September 30, 2022, the carrying value of long-term debt approximated fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions.
Restricted cash	Restricted cashAs of September 30, 2022 and December 31, 2021, the restricted cash balance included in prepaid expenses and other assets was $41 and $13, respectively.
Net product revenues and licensing revenues	Net product revenues The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted on January 1, 2018. The Company recognizes revenue from XHANCE sales at the point customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration. The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. The components of the Company’s variable consideration include the following: Provider Chargebacks and Discounts. Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Trade Discounts and Allowances. The Company generally provides customers with discounts that include incentive fees which are explicitly stated in the Company’s contracts. These discounts are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized. Product Returns. Consistent with industry practice, the Company has a product returns policy that provides customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The Company estimates the amount of its product that may be returned and presents this amount as a reduction of revenue in the period the related product revenue is recognized, in addition to establishing a liability. The Company considers several factors in the estimation process, including expiration dates of product shipped to customers, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors. Government Rebates. The Company is subject to discount obligations under state Medicaid programs and Medicare. Reserves related to these discount obligations are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel inventories at the end of the reporting period. Payor Rebates. The Company contracts with certain third-party payors, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the plan or the organization with which it contracts. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Patient Assistance. Other programs that the Company offers include voluntary co-pay patient assistance programs intended to provide financial assistance to eligible patients with prescription drug co-payments required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. Distribution and Other Fees. The Company pays distribution and other fees to certain customers in connection with the sales of its products. The Company records distribution and other fees paid to its customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and the Company can reasonably estimate the fair value of the goods or services received. If both conditions are met, the Company records the consideration paid to the customer as an operating expense. These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale. Licensing revenues The Company has license agreements with Centessa Pharmaceuticals (Centessa) and Currax Pharmaceuticals LLC (Currax). These license agreements provide for exclusive licensed rights to certain intellectual property, a non-refundable up-front payment, potential milestone payment(s) and potential royalty payment(s). The Company analyzed the performance obligations under the license agreements, the consideration received to date and the consideration the Company could receive in the future as part of its analysis related to ASC 606. The Company is not eligible to receive any further payments under the Currax license agreement other than reimbursement for certain expenses. The Company does not expect to any receive license revenues under the Centessa agreement in the near term.
Net income (loss) per common share	Net income (loss) per common shareBasic net income (loss) per common share is determined by dividing net income (loss) applicable to Company common stock (Common Stock) holders by the weighted average common shares outstanding during the period. For the three and nine months ended September 30, 2022 and 2021, the outstanding Common Stock options, Restricted Stock units, Common Stock warrants and shares to be issued under the Company's 2017 Employee Stock Purchase Plan have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, the weighted average shares used to calculate both basic and diluted net loss per share are the same.
Income taxes	Income taxes In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes, the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and nine months ended September 30, 2022 and 2021, the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. As of September 30, 2022 and December 31, 2021, the Company concluded that a full valuation allowance would be necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest or penalties in the accompanying consolidated financial statements.

- Definition

Disclosure of accounting policy for income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements.

+ References + Details

- Definition

Disclosure of accounting policy for revenue from contract with customer.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 17
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+ Details

Basis of Presentation and Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Schedule of Antidilutive Shares Excluded From Computation of Net Loss Per Common Share

Diluted net loss per common share for the periods presented do not reflect the following potential common shares, as the effect would be antidilutive:


	September 30,
	2022	2021
Stock options	9,581,947	7,928,817
Restricted stock units	1,871,021	2,013,934
Common stock warrants	2,500,000	810,357
Employee stock purchase plan	74,935	123,754
Total	14,027,903	10,876,862

Inventory (Tables)

9 Months Ended

Sep. 30, 2022

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventory consisted of the following:


	September 30, 2022		December 31, 2021
Raw materials	$	1,894	$	3,504
Work-in-process	5,610		4,816
Finished goods	2,911		3,527
Total inventory	$	10,415	$	11,847

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment

Property and equipment, net, consisted of the following:


	September 30, 2022		December 31, 2021
Computer equipment and software	$	1,203	$	1,173
Furniture and fixtures	366		366
Machinery and equipment	3,061		3,367
Leasehold improvements	609		609
Construction in process	115		115
	5,354		5,630
Less: accumulated depreciation	(4,453)		(4,283)
	$	901	$	1,347

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Schedule of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of:


	September 30, 2022		December 31, 2021
Accrued expenses:
Selling, general and administrative expenses	$	5,842	$	6,124
Research and development expenses	2,380		6,857
Payroll expenses	7,506		7,569
Product revenue allowances	21,018		26,521
Other	2,293		2,057
Total accrued expenses	39,039		49,128
Other current liabilities:
Lease liability	2,246		2,094
Total other current liabilities	2,246		2,094
Total accrued expenses and other current liabilities	$	41,285	$	51,222

Debt (Tables)

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Schedule of Long-term Debt Instruments

The Pharmakon debt balance is comprised of the following:



	September 30, 2022		December 31, 2021
Face amount	$	130,000	$	130,000
Front end fees	(483)		(717)
Debt issuance costs	(3,490)		(4,165)
Back end fees	2,080		1,300
Debt, net	$	128,107	$	126,418

- 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

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+ Details

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Schedule of Warrants Outstanding

As of September 30, 2022, the Company had the following warrants outstanding to purchase shares of Common Stock:

Number of Shares

Exercise Price Per Share

Expiration Date

2,500,000

$1.60

November 18, 2024

Stock-based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Schedule of Allocated Stock-Based Compensation Expense


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Cost of product sales	$	10	$	20	$	30	$	38
Research and development	219		298		648		865
General and administrative	1,721		2,366		6,716		7,124
	$	1,950	$	2,684	$	7,394	$	8,027

Schedule of Stock Option Activity

The following table summarizes the activity related to stock option grants to employees and non-employees for the nine months ended September 30, 2022:


	Shares	Weighted average exercise price per share		Weighted average remaining contractual life
Outstanding at December 31, 2021	7,958,781	$	8.87	6.50
Granted	2,932,370	1.90
Exercised	(95,000)	2.18
Expired	(639,288)	10.08
Forfeited	(574,916)	3.72
Outstanding at September 30, 2022	9,581,947	$	7.03	6.31
Exercisable at September 30, 2022	5,526,439	$	10.19	4.98
Vested and expected to vest at September 30, 2022	8,688,917	$	7.57	6.31

Schedule of Fair Value Options using Black-Scholes Pricing Model


	Nine Months Ended September 30,
	2022			2021
Risk free interest rate	1.84		%	1.00		%
Expected term (in years)	6.08			6.08
Expected volatility	72.69		%	74.18		%
Annual dividend yield	0.00		%	0.00		%
Fair value of common stock	$	1.92		$	3.48

The grant date fair value of each stock option grant, as well as the derived service period for these awards, was estimated at the time of grant using a Monte Carlo simulation based on the following assumptions:


	Nine Months Ended September 30,
	2022
Risk free rates of return	1.70	%
Expected volatility	75.00	%
Annual dividend yield	—	%

The Company calculated the fair value of each option grant and the shares issued under the 2017 Plan on the respective dates of grant using the following weighted average assumptions:


	Nine Months Ended September 30,
	2022		2021
Risk free interest rate	0.17	%	0.07	%
Expected term (in years)	0.5		0.5
Expected volatility	88.13	%	65.43	%
Annual dividend yield	0.00	%	0.00	%

Schedule of Nonvested Restricted Stock Units Activity

The following table summarizes the activity related to RSUs granted to employees for the nine months ended September 30, 2022:


			Shares
Outstanding at December 31, 2021			1,959,358
Granted			1,105,246
Vested and settled			(838,867)
Expired/forfeited/canceled			(354,716)
Outstanding at September 30, 2022			1,871,021
Expected to vest at September 30, 2022			1,871,021

Liquidity (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Liquidity (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Nov. 09, 2022	Aug. 10, 2022	Dec. 31, 2021
Revenue from External Customer [Line Items]
Cash and cash equivalents	$ 61,080						$ 61,080				$ 110,502
Net loss	(14,954)	$ (19,397)	$ (25,333)	$ (17,117)	$ (23,502)	$ (26,053)	(59,684)	$ (66,672)
Cash used in operating activities							49,971	$ 60,219
Accumulated deficit	$ (669,745)						$ (669,745)				$ (610,061)
Note Purchase Agreement
Revenue from External Customer [Line Items]
Fee due on the maturity date of the note purchase agreement										$ 780
Note Purchase Agreement \| Subsequent Event
Revenue from External Customer [Line Items]
Fee due on the maturity date of the note purchase agreement									$ 1,300
XHANCE \| Note Purchase Agreement \| Subsequent Event
Revenue from External Customer [Line Items]
Fee due on the maturity date of the note purchase agreement									$ 1,300

- Definition

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

+ References

+ Details

Basis of Presentation and Summary of Significant Accounting Policies - Concentration of Credit Risk (Details) - Customer Concentration Risk - Five Customers	3 Months Ended	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2022
Accounts Receivable
Concentration Risk [Line Items]
Concentration risk (as a percent)		40.00%
Sales Revenue, Net
Concentration Risk [Line Items]
Concentration risk (as a percent)	31.00%	29.00%

Basis of Presentation and Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Restricted cash	$ 41	$ 13

Basis of Presentation and Summary of Significant Accounting Policies - Antidilutive Shares Excluded From Computation of Net Loss Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securities excluded from computation of net loss per common share (in shares)	14,027,903	10,876,862
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securities excluded from computation of net loss per common share (in shares)	9,581,947	7,928,817
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securities excluded from computation of net loss per common share (in shares)	1,871,021	2,013,934
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securities excluded from computation of net loss per common share (in shares)	2,500,000	810,357
Employee stock purchase plan
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securities excluded from computation of net loss per common share (in shares)	74,935	123,754

Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 1,894	$ 3,504
Work-in-process	5,610	4,816
Finished goods	2,911	3,527
Total inventory	$ 10,415	$ 11,847

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 5,354	$ 5,630
Less: accumulated depreciation	(4,453)	(4,283)
Property and equipment, net	901	1,347
Computer equipment and software
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,203	1,173
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Property and equipment, gross	366	366
Machinery and equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	3,061	3,367
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property and equipment, gross	609	609
Construction in process
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 115	$ 115

Property and Equipment - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Property, Plant and Equipment [Line Items]
Depreciation	$ 144	$ 153	$ 399	$ 476
Inventory
Property, Plant and Equipment [Line Items]
Depreciation			667
Prepaid expenses and other assets
Property, Plant and Equipment [Line Items]
Depreciation			$ 17

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Accrued expenses:
Selling, general and administrative expenses	$ 5,842	$ 6,124
Research and development expenses	2,380	6,857
Payroll expenses	7,506	7,569
Product revenue allowances	21,018	26,521
Other	2,293	2,057
Total accrued expenses	39,039	49,128
Other current liabilities:
Lease liability	2,246	2,094
Total other current liabilities	2,246	2,094
Total accrued expenses and other current liabilities	$ 41,285	$ 51,222

Licensing Revenue (Details) - USD ($) $ in Thousands		1 Months Ended	12 Months Ended
Licensing Revenue (Details) - USD ($) $ in Thousands	Dec. 29, 2020	Jan. 31, 2021	Dec. 31, 2019
Currax License Agreement
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Upfront payment received			$ 3,730
Additional revenue eligible and held in escrow	$ 750
Royalty Agreement Terms
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Sales milestone payments eligible to be received (up to)		$ 1,000

Debt - Narrative (Details) - USD ($) $ in Thousands		3 Months Ended				9 Months Ended
Debt - Narrative (Details) - USD ($) $ in Thousands	Sep. 12, 2019	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2019	Sep. 30, 2022	Sep. 30, 2021	Nov. 09, 2022	Aug. 10, 2022	Aug. 09, 2022	Dec. 01, 2020	Feb. 13, 2020
Note Purchase Agreement
Debt Instrument [Line Items]
Fee due on the maturity date of the note purchase agreement									$ 780
Note Purchase Agreement \| Subsequent Event
Debt Instrument [Line Items]
Fee due on the maturity date of the note purchase agreement								$ 1,300
Note Purchase Agreement \| XHANCE \| Subsequent Event
Debt Instrument [Line Items]
Fee due on the maturity date of the note purchase agreement								1,300
Senior Notes
Debt Instrument [Line Items]
Bearing fixed interest, percentage rate	10.75%
Equal quarterly installments of principal repayment	5 years
Senior Notes \| Note Purchase Agreement
Debt Instrument [Line Items]
Debt maximum borrowing capacity	$ 130,000
Debt face amount	$ 80,000
Trailing twelve month net revenue covenant									$ 85,000	$ 90,000
Prepayment fee, after second and before third anniversary	2.00%
Prepayment fee, after third and before fourth anniversary	1.00%
Prepayment premium amount	$ 0
Interest expense		$ 4,207	$ 4,072			$ 12,365	$ 11,959
Senior Notes \| Note Purchase Agreement \| Subsequent Event
Debt Instrument [Line Items]
Debt covenant, cash and cash equivalents								$ 30,000
Senior Notes \| Note Purchase Agreement \| Debt Instrument, Redemption, Period One
Debt Instrument [Line Items]
Debt instrument, make-whole provision, payment accrual period	30 months
Senior Notes \| Note Purchase Agreement \| Debt Instrument, Redemption, Period Two
Debt Instrument [Line Items]
Debt instrument, make-whole provision, payment accrual period	15 months
Senior Notes \| Note Purchase Agreement - First Delayed Draw Notes
Debt Instrument [Line Items]
Debt face amount												$ 30,000
Senior Notes \| Note Purchase Agreement - First Delayed Draw Notes \| Quarter Ended December 31, 2019
Debt Instrument [Line Items]
Debt issuance criteria term, net sales and royalties benchmark					$ 9,000
Senior Notes \| Note Purchase Agreement - Third Delayed Draw Notes
Debt Instrument [Line Items]
Debt face amount											$ 20,000
Senior Notes \| Note Purchase Agreement - Third Delayed Draw Notes \| Quarter Ended September 30, 2020
Debt Instrument [Line Items]
Debt issuance criteria term, net sales and royalties benchmark				$ 14,500

Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Short-term Debt [Line Items]
Debt, net	$ 0	$ 126,418
Note Purchase Agreement \| Senior Notes
Short-term Debt [Line Items]
Face amount	130,000	130,000
Front end fees	(483)	(717)
Debt issuance costs	(3,490)	(4,165)
Back end fees	2,080	1,300
Debt, net	$ 128,107	$ 126,418

- Definition

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

+ References + Details

Employee Benefit Plans (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Employee Benefit Plans (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Defined Contribution Plan Disclosure [Line Items]
Accrued liabilities related to the Company match	$ 125		$ 125
Norway and UK employee plans
Defined Contribution Plan Disclosure [Line Items]
Defined contribution plan, cost	$ 1	$ 1	$ 4	$ 5

Stockholders' Equity - Narrative (Details) - USD ($)	Sep. 30, 2022	Nov. 18, 2021
Warrants Expiring November 18, 2024
Class of Stock [Line Items]
Number of shares called by warrants (in shares)		2,500,000
Warrants exercise price (in USD per share)	$ 1.60	$ 1.60
Warrants and rights outstanding		$ 2,009,000
Warrants Expiring September 12, 2022
Class of Stock [Line Items]
Warrants exercise price (in USD per share)		$ 6.72
Warrants cancelled (in shares)		810,357

Stockholders' Equity - Schedule of Warrants Outstanding (Details) - Warrants Expiring November 18, 2024 - $ / shares	Sep. 30, 2022	Nov. 18, 2021
Class of Stock [Line Items]
Warrants outstanding (in shares)	2,500,000
Warrants outstanding, measurement input (in USD per share)	$ 1.60	$ 1.60

Stock-based Compensation - Allocated Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,950	$ 2,684	$ 7,394	$ 8,027
Cost of product sales
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	10	20	30	38
Research and development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	219	298	648	865
General and administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,721	$ 2,366	$ 6,716	$ 7,124

Stock-based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended		9 Months Ended
	Jun. 15, 2022	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense		$ 1,950	$ 2,684	$ 7,394	$ 8,027
Plan options contractual life (up to)				10 years
Award vesting period				4 years
Service Based Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Award vesting period				4 years	4 years
Stock options to purchase shares (in shares)				2,932,370	1,615,696
Weighted average grant date fair value (usd per share)				$ 1.19	$ 2.26
Unrecognized cost related to unvested RSUs expected to vest		5,439		$ 5,439
Estimated weighted-average amortization period				2 years 2 months 1 day
Market Based Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Award vesting period				2 years
Stock options to purchase shares (in shares)				959,215
Stock options to purchase shares, vested (in shares)				297,677
Restricted stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,514
Award vesting period				4 years
Granted (in shares)				1,105,246
Restricted shares fair value at grant date (usd per share)				$ 1.85
Vested and settled (in shares)	248,830			838,867
Restricted Stock Units, Service-Based
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized cost related to unvested RSUs expected to vest		4,214		$ 4,214
Estimated weighted-average amortization period				2 years 5 months 15 days
Restricted Stock Units, Performance-Based
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized cost related to unvested RSUs expected to vest		1,178		$ 1,178
NASDAQ Inducement Grant Exception \| Restricted stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)				60,000
2017 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense		$ 53	$ 65	$ 215	$ 264
2017 Plan \| Employee Stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
ESPP purchase price of common stock, percent of market price				85.00%
Inventory
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense				$ 82
Prepaid expenses and other assets
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense				$ 1

Stock-based Compensation - Stock Option Activity (Details) - Service Based Stock Options - $ / shares	9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Shares
Beginning balance (in shares)	7,958,781
Granted (in shares)	2,932,370	1,615,696
Exercised (in shares)	(95,000)
Expired (in shares)	(639,288)
Forfeited (in shares)	(574,916)
Ending balance (in shares)	9,581,947		7,958,781
Exercisable (in shares)	5,526,439
Vested and expected to vest (in shares)	8,688,917
Weighted average exercise price per share
Beginning balance (usd per share)	$ 8.87
Granted (usd per share)	1.90
Exercised (usd per share)	2.18
Expired (usd per share)	10.08
Forfeited (usd per share)	3.72
Ending balance (usd per share)	7.03		$ 8.87
Exercisable (usd per share)	10.19
Vested and expected to vest (usd per share)	$ 7.57
Weighted average remaining contractual life
Options outstanding, weighted average remaining contractual life	6 years 3 months 21 days		6 years 6 months
Options exercisable, weighted average remaining contractual life	4 years 11 months 23 days
Vested and expected to vest, weighted average remaining contractual life	6 years 3 months 21 days

Stock-based Compensation - Fair Value Options using Black-Scholes Pricing Model (Details) - $ / shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
2017 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free interest rate	0.17%	0.07%
Expected term (in years)	6 months	6 months
Expected volatility	88.13%	65.43%
Annual dividend yield	0.00%	0.00%
Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free interest rate	1.84%	1.00%
Expected term (in years)	6 years 29 days	6 years 29 days
Expected volatility	72.69%	74.18%
Annual dividend yield	0.00%	0.00%
Fair value of common stock (usd per share)	$ 1.92	$ 3.48
Market Based Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free rates of return	1.70%
Expected volatility	75.00%
Annual dividend yield	0.00%

Stock-based Compensation - Restricted Stock Units Activity (Details) - Restricted stock units - shares		9 Months Ended
	Jun. 15, 2022	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Beginning balance (in shares)		1,959,358
Granted (in shares)		1,105,246
Vested and settled (in shares)	(248,830)	(838,867)
Expired/ forfeited/ canceled (in shares)		(354,716)
Ending balance (in shares)		1,871,021
Expected to vest at end of period (in shares)		1,871,021