0001494650-22-000019 | 10-K | XBRL Viewer

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Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 110,502	$ 144,156
Accounts receivable, net	35,449	23,394
Inventory	11,847	9,042
Prepaid expenses and other current assets	2,581	4,060
Total current assets	160,379	180,652
Property and equipment, net	1,347	2,028
Other assets	4,345	6,133
Total assets	166,071	188,813
Current liabilities:
Accounts payable	8,013	5,489
Accrued expenses	51,222	46,683
Total current liabilities	59,235	52,172
Long-term debt, net	126,418	125,202
Other liabilities	2,190	4,651
Total liabilities	187,843	182,025
Commitments and contingencies (Note 11)
Stockholders' equity (deficit):
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2021 and 2020; 82,238,900 and 52,945,865 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively	82	53
Additional paid-in capital	588,288	534,585
Accumulated deficit	(610,061)	(527,765)
Accumulated other comprehensive loss	(81)	(85)
Total stockholders' equity (deficit)	(21,772)	6,788
Total liabilities and stockholders' equity (deficit)	$ 166,071	$ 188,813

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
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)	82,238,900	52,945,865
Shares outstanding (in shares)	82,238,900	52,945,865

Consolidated Statements of Operations - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Total revenues	$ 74,652	$ 49,117
Costs and expenses:
Cost of product sales	9,151	7,520
Research and development	25,318	23,378
Selling, general and administrative	106,633	105,438
Total costs and expenses	141,102	136,336
Loss from operations	(66,450)	(87,219)
Other (income) expense:
Other income	(75)	0
Interest income	(52)	(442)
Interest expense	15,973	13,008
Net loss	$ (82,296)	$ (99,785)
Net (loss) income per share of common stock, basic (in USD per share)	$ (1.45)	$ (2.07)
Net (loss) income per share of common stock, diluted (in USD per share)	$ (1.45)	$ (2.07)
Weighted average common shares outstanding, basic (in shares)	56,851,921	48,275,230
Weighted average common shares outstanding, diluted (in shares)	56,851,921	48,275,230
Net product revenues
Total revenues	$ 73,652	$ 48,367
Licensing revenues
Total revenues	$ 1,000	$ 750

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Statement of Comprehensive Income [Abstract]
Net loss	$ (82,296)	$ (99,785)
Other comprehensive loss:
Foreign currency translation adjustment	4	(37)
Comprehensive loss	$ (82,292)	$ (99,822)

- 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
Shares outstanding (in shares) at Dec. 31, 2019		45,906,162
Beginning balance at Dec. 31, 2019	$ 61,583	$ 46	$ 489,565	$ (427,980)	$ (48)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	10,284		10,284
Sale of common stock, net of issuance costs (in shares)		6,000,000
Sale of common stock, net of issuance costs	33,401	$ 6	33,395
Issuance of warrants in connection with Pharmakon Second Amendment, net of cancellation	0
Exercise of common stock options (in shares)		826,266
Exercise of common stock options	228	$ 1	227
Issuance of common stock under employee stock purchase plan (in shares)		168,794
Issuance of common stock under employee stock purchase plan	864		864
Issuance of common stock in connection with Pharmakon Amendment (in shares)		44,643
Issuance of common stock in connection with Pharmakon Amendment	250		250
Foreign currency translation adjustment	(37)				(37)
Net loss	(99,785)			(99,785)
Shares outstanding (in shares) at Dec. 31, 2020		52,945,865
Ending balance at Dec. 31, 2020	6,788	$ 53	534,585	(527,765)	(85)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock compensation expense	9,977		9,977
Vesting of restricted stock units (in shares)		383,631
Vesting of restricted stock units	0
Sale of common stock, net of issuance costs (in shares)		28,750,000
Sale of common stock, net of issuance costs	42,814	$ 29	42,785
Issuance of warrants in connection with Pharmakon Second Amendment, net of cancellation	534		534
Exercise of common stock options (in shares)		23,879
Exercise of common stock options	39		39
Issuance of common stock under employee stock purchase plan (in shares)		135,525
Issuance of common stock under employee stock purchase plan	368		368
Foreign currency translation adjustment	4				4
Net loss	(82,296)			(82,296)
Shares outstanding (in shares) at Dec. 31, 2021		82,238,900
Ending balance at Dec. 31, 2021	$ (21,772)	$ 82	$ 588,288	$ (610,061)	$ (81)

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Operating activities:
Net loss	$ (82,296)	$ (99,785)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	646	1,456
Stock-based compensation	10,003	10,349
Amortization of debt discount and issuance costs	1,795	1,193
Allowance for doubtful accounts	(233)	677
Gain on sale of equipment	(67)	0
Changes in operating assets and liabilities:
Accounts receivable	(11,823)	(10,427)
Grants and other receivables	43	175
Prepaid expenses and other assets	3,543	1,074
Inventory	(2,713)	(5,428)
Accounts payable	2,564	2,196
Accrued expenses and other liabilities	1,603	12,314
Cash used in operating activities	(76,935)	(86,206)
Investing activities:
Purchases of property and equipment	(167)	(546)
Proceeds from Sale of Property, Plant, and Equipment	105	0
Cash used in investing activities	(62)	(546)
Financing activities:
Proceeds from the sale of common stock	43,140	33,600
Proceeds from long-term debt	0	54,447
Proceeds from the issuance of common stock under employee stock purchase plan	368	865
Proceeds from the exercise of stock options	39	228
Cash paid for financing costs	(227)	(883)
Repayment of long-term debt	0	(4,447)
Cash provided by financing activities	43,320	83,810
Effects of exchange rate changes on cash and cash equivalents	13	(44)
Net decrease in cash, cash equivalents and restricted cash	(33,664)	(2,986)
Cash, cash equivalents and restricted cash at beginning of period	144,179	147,165
Cash, cash equivalents and restricted cash at end of period	110,515	144,179
Supplemental disclosure of cash flow information:
Cash paid for interest	14,170	11,561
Supplemental disclosure of noncash activities:
Fixed asset purchases within accounts payable and accrued expenses	11	52
Fair value of warrants issued in connection with Pharmakon amendment, net of cancelled	534	0
Fair value of common stock issued in connection with Pharmakon amendment	0	250
Financing costs within accounts payable and accrued expenses	318	65
Recognition of right-of-use assets	157	6,174
Recognition of lease liabilities	$ 157	$ 6,174

Organization and Description of Business	12 Months Ended
Organization and Description of Business	Dec. 31, 2021
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. 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 microgram (mcg), is a therapeutic utilizing the Company's 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 known 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	12 Months Ended
Liquidity	Dec. 31, 2021
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, launching XHANCE in the US. As of December 31, 2021, the Company had cash and cash equivalents of $110,502. On November 16, 2021, the Company entered into the second amendment (the Second Amendment) to the Note Purchase Agreement. The Second Amendment revised certain minimum trailing twelve-month consolidated XHANCE net sales and royalties the Company is required to achieve and amended the "make-whole" provision with respect to certain principal prepayments. Upon execution of the Second Amendment, the interest-only period of amounts due under the Note Purchase Agreement was extended from December 2022 to September 2023. Principal repayments will commence on September 15, 2023, with five equal quarterly installments of principal and interest through to the maturity date. On November 18, 2021, the Company closed an underwritten public offering (the Offering) of 28,750,000 shares of Company common stock (Common Stock) at a price of $1.60 per share. As a result of the Offering, the Company received $42,842 in net proceeds, after deducting commissions and expenses of $2,860 and offering costs payable by the Company of $298. 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 Company's outstanding senior secured notes, and to carry out the Company's planned development and commercial activities. The terms of the outstanding senior secured notes, including applicable covenants, are described in Note 9. If additional capital is not obtained when required, the Company may need to delay or curtail its operations until additional funding is received. 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.

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Summary of Significant Accounting Policies

Basis of presentation

The accompanying 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).

Principles of consolidation

The consolidated financial statements include the accounts of OptiNose, Inc. and its wholly-owned subsidiaries, OptiNose US, Inc., OptiNose AS and OptiNose UK Ltd. All inter-company balances and transactions have been eliminated in consolidation.

Use of estimates

The preparation of the 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 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 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 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 36% of the Company's accounts receivable at December 31, 2021 and five customers represented approximately 31% of the Company's net product sales for the year ended December 31, 2021.

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.

Cash and cash equivalents

All highly liquid investments purchased with an original maturity date of three months or less at the date of purchase are considered to be cash equivalents. The Company maintains its cash and cash equivalent balances at foreign and domestic financial institutions. Bank deposits with Norwegian banks are insured up to approximately 2,000 Norwegian krone by the Norwegian Banks' Guarantee Fund. Bank deposits with US banks are insured up to $250 by the Federal Deposits Insurance Corporation. The Company had uninsured cash balances of $109,017 and $141,944 at December 31, 2021 and 2020, respectively.

Restricted cash

As of December 31, 2021 and 2020, the restricted cash balance included in prepaid expenses and other assets was $13 and $23, respectively.

Fair value of financial instruments

The Company measures certain assets and liabilities at fair value, which is defined as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The FASB accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company uses quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of the inputs as follows:

•Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

•Level 2 — Valuations based on observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

•Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement.

At December 31, 2021 and 2020, 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 approximates their respective fair values because of the short-term nature of these instruments. In addition, at December 31, 2021, the Company believed the carrying value of debt approximates fair value as the interest rates were reflective of the rate the Company could obtain on debt with similar terms and conditions. At December 31, 2021 and 2020, there were no financial assets or liabilities measured at fair value on a recurring basis.

Accounts receivable

Accounts receivable primarily relates to amounts due from customers, which are typically due within 31 to 61 days. The Company analyzes accounts that are past due for collectability. The Company recognized an allowance for doubtful accounts related to customers subject to credit risk of $444 and $677 at December 31, 2021 and 2020, respectively. The accounts receivable balance at December 31, 2021 and 2020 on the accompanying balance sheet is net of the allowance.

Inventory

Inventories are stated at the lower of cost or net realizable value. Costs of inventories, which include amounts related to materials and manufacturing overhead, are determined on a first-in, first-out basis. An assessment of the recoverability of capitalized inventory is performed during each reporting period and any excess and obsolete inventories are written down to their estimated net realizable value in the period in which the impairment is first identified.

Property and equipment

Property and equipment is recorded at cost less accumulated depreciation. Significant additions or improvements are capitalized and expenditures for repairs and maintenance are charged to expense as incurred. Gains and losses on disposal of assets are included in the consolidated statements of operations. Depreciation is calculated on a straight-line basis over the estimated useful lives of the respective assets.

The estimated useful lives of property and equipment are as follows:

Computer equipment

2-3 years

Software

3 years

Machinery & production equipment

5-10 years

Furniture & fixtures

3-5 years

Leasehold improvements

Shorter of lease term or useful life

Long lived assets

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company did not recognize any impairment or disposition of long-lived assets for the years ended December 31, 2021 and 2020.

Net product revenues

The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606), which was adopted on January 1, 2018. The Company performs the following five steps to recognize revenue under ASC 606: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer.

The Company sells XHANCE to preferred pharmacy network partners and wholesalers in the US (collectively, Customers). These Customers subsequently resell the Company’s products to healthcare providers, patients and other retail pharmacies. In addition to agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts for the purchase of the Company’s products.

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 which is described below. Payment terms with Customers do not exceed one year and, therefore, the Company does not account for a financing component in its arrangements. The Company expenses incremental costs of obtaining a contract with a Customer (for example, sales commissions) when incurred as the period of benefit is less than one year. Shipping and handling costs for product shipments to Customers are recorded as selling, general and administrative expenses.

Transaction Price, including Estimates of Variable Consideration

Revenue from products is recognized at the estimated net sales price (transaction price), which includes estimates of variable consideration. The Company includes estimated amounts in the transaction price to the extent it is determined probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. 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 products 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 current 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 reporting period 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. We pay distribution and other fees to certain customers in connection with the sales of our products. We record distribution and other fees paid to our customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and we can reasonably estimate the fair value of the goods or services received. If both conditions are met, we record 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) (Note 8). 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 recognized $1,000 and $750 as licensing revenue during the years ended December 31, 2021 and 2020, respectively.

Advertising expenses

The Company expenses the costs of advertising, including promotional expenses, as incurred. Advertising expenses were $15,638 and $15,015 for the years ended December 31, 2021 and 2020, respectively.

Research and development

Research and development costs are expensed as incurred. Research and development costs consist primarily of device development, clinical trial related costs and regulatory related costs. The Company enters into agreements with contract research organizations (CROs) to facilitate, coordinate and perform agreed upon research and development activities for the Company's clinical trials. These CRO contracts typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain clinical trial milestones. The Company prepays certain CRO fees whereby the prepayments are recorded as a current or non-current prepaid asset and are amortized into research and development expense over the period of time the contracted research and development services were performed. The Company's CRO contracts generally also include other fees such as project management and pass through fees whereby the Company expenses these costs as incurred, using the Company's best estimate. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, travel costs, and other miscellaneous costs. Pass through fees incurred are based on the amount of work completed for the clinical trials and are monitored through reporting provided by the Company's CROs.

Stock-based compensation

The Company measures and recognizes compensation expense for all stock options and restricted stock units (RSUs) awarded to employees and non-employees and shares issued under the employee stock purchase plan based on the estimated fair value of the awards on the respective grant dates. The Company uses the Black-Scholes option pricing model to value its stock option and shares issued under the employee stock purchase plan. RSUs are valued at the fair market value per share of the Company's common stock on the date of grant. The Company recognizes compensation expense for time-based awards on a straight-line basis over the requisite service period, which is generally the vesting period of the award. The Company recognizes compensation expense for performance based awards when the performance condition is probable of achievement. The Company accounts for forfeitures of stock option awards as they occur.

Estimating the fair value of options and shares issued under the employee stock purchase plan requires the input of subjective assumptions, including the estimated fair value of the Company's common stock, the expected life of the options, stock price volatility, the risk-free interest rate and expected dividends. The assumptions used in the Company's Black-Scholes option-pricing model represent management's best estimates and involve a number of variables, uncertainties and assumptions and the application of management's judgment, as they are inherently subjective.

Income taxes

Income taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on the weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of December 31, 2021 and 2020, the Company concluded that a full valuation allowance was 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.

Net income (loss) per common share

Basic net income (loss) per common share is determined by dividing net income (loss) applicable to common stockholders by the weighted average common shares outstanding during the period. For the years ended December 31, 2021 and 2020, outstanding common stock options and common stock warrants 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 does not reflect the following potential common shares, as the effect would be antidilutive:


	Year Ended December 31,
	2021	2020
Stock options	7,958,781	6,852,733
Restricted stock units	1,959,358	1,491,589
Common stock warrants	2,500,000	810,357

Total	12,418,139	9,154,679

Recent accounting pronouncements

In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Top 832): Disclosures by Business Entities about Government Assistance. ASU No. 2021-10 is intended to increase the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. Diversity currently exists in the recognition, measurement, presentation, and disclosure of government assistance received by business entities because of the lack of specific authoritative guidance in generally accepted accounting principles (GAAP). Requiring disclosures about government assistance in the notes to financial statements will provide comparable and transparent information to investors and other financial statement users to enable them to understand an entity’s financial results and prospects for future cash flows. The new standard is effective for fiscal years beginning after December 15, 2021, with early adoption permitted. The Company does not expect ASU No. 2021-10 to have a significant impact on its results of operations, financial position and cash flows and related disclosures

In July 2021, the FASB issued ASU No. 2021-05, Leases (Topic 842): Lessors—Certain leases with variable payments. ASU No. 2021-05 is intended to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing transactions. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. The Company adopted ASU No. 2021-05 on January 1, 2021. The implementation did not have a material effect on the Company’s results of operations, financial position and cash flows and related disclosures.

In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU No. 2021-04 requires that issuers clarify and reduce diversity in accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after the modification or exchange. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. The Company adopted ASU No. 2021-04 on January 1, 2021. The implementation did not have a material effect on the Company’s results of operations, financial position and cash flows and related disclosures.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 eliminated certain exceptions and changed guidance on other matters. The exceptions relate to the allocation of income taxes in separate company financial statements, tax accounting for equity method investments and accounting for income taxes when the interim period year-to-date loss exceeds the anticipated full year loss. Changes relate to the accounting for franchise taxes that are income-based and non-income-based, determining if a step up in tax basis is part of a business combination or if it is a separate transaction, when enacted tax law changes should be included in the annual effective tax rate computation, and the allocation of taxes in separate company financial statements to a legal entity that is not subject to income tax. The Company has adopted ASU 2019-12 in the first quarter of 2021, and there was no significant impact.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-03, in conjunction with ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments - Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, introduces an approach, based on expected losses, to estimate credit losses on certain types of financial instruments and modifies the impairment model for available-for-sale debt securities. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022 for companies deemed to be smaller reporting companies as of November 15, 2019, with early adoption permitted. The Company has adopted ASU 2016-13 and there was no significant impact.

Inventory

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Inventory

InventoryInventory consisted of the following:


	December 31,
	2021		2020
Raw materials	$	3,504	$	2,669
Work-in-process	4,816		2,676
Finished goods	3,527		3,697
Total inventory	$	11,847	$	9,042

Property and Equipment

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Property and Equipment

Property and EquipmentProperty and equipment, net, consisted of:


	December 31,
	2021		2020
Computer equipment and software	$	1,173	$	1,128
Furniture and fixtures	366		366
Machinery and equipment	3,367		3,440
Leasehold improvements	609		609
Construction in process	115		271
	5,630		5,814
Less: accumulated depreciation	(4,283)		(3,786)
	$	1,347	$	2,028

Depreciation expense was $645 and $1,454 for the years ended December 31, 2021 and 2020, respectively. In addition, depreciation expense of $576 and $4 was charged to inventory and prepaid expenses and other assets, respectively, as of December 31, 2021, which represents depreciation expense related to equipment involved in the manufacturing process.

Leases

12 Months Ended

Dec. 31, 2021

Leases [Abstract]

Leases

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) to require the recognition of lease assets and liabilities on the balance sheet of lessees. The Company implemented ASU 2016-02 as of January 1, 2019 using the optional modified retrospective transition method and elected the following transition practical expedients: (i) to not reassess lease identification, lease classification and initial indirect costs related to those leases entered into prior to the adoption of ASC 842; and (ii) to not separate lease and non-lease components for its office lease portfolio. As of the implementation date, all of the Company's leases were operating leases and its total operating lease assets and liabilities were $2,411 and $2,887, respectively.

The Company leases office space, storage space and equipment (primarily vehicles). The Company evaluates renewal options at lease inception 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. Lease agreements generally do not require material variable lease payments, residual value guarantees or restrictive covenants.

The table below presents the operating lease assets and liabilities recognized on the Company's consolidated balance sheets:


	Balance Sheet Line Item	December 31, 2021		December 31, 2020
Non-current operating lease assets	Other assets	$	4,051	$	5,978
Operating lease liabilities:
Current operating lease liabilities	Accrued expenses and other current liabilities	2,094		2,108
Non-current operating lease liabilities	Other liabilities	2,190		4,161
Total operating lease liabilities		$	4,284	$	6,269

The depreciable lives of operating lease asset leasehold improvements are limited by the lease term.

The Company's leases generally do not provide an implicit rate, and therefore, the Company uses its incremental borrowing rate as the discount rate when measuring operating leases liabilities. 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 a lease. The Company used the incremental borrowing rates as of January 1, 2019 for operating leases that commenced prior to that date.

The Company's weighted average remaining lease term and weighted average discount rate for operating leases as of December 31, 2021 are:


	December 31, 2021
Weighted average remaining lease term (years)	2.09
Weighted average discount rate	4.55	%

The table below reconciles the undiscounted future minimum lease payments (displayed in aggregate by year) under non-cancelable operating leases with terms of more than one year to the total operating lease liabilities recognized on the consolidated balance sheets as of December 31, 2021:


	December 31, 2021
2022	$	2,461
2023	1,831
2024	424
Thereafter	—
Total undiscounted future minimum lease payments	4,716
Less: difference between undiscounted lease payments and discounted operating lease liabilities	432
Total operating lease liabilities	$	4,284

No operating lease payments include options to extend lease terms that are reasonably certain of being exercised for the year ended December 31, 2021.

Operating lease costs were $2,843 and $2,770 for the years ended December 31, 2021 and 2020, respectively. Operating lease costs are included within selling, general and administrative expenses on the consolidated statements of operations.

Cash paid for amounts included in the measurement of operating lease liabilities were $2,466 and $857 for the years ended December 31, 2021 and 2020, respectively. This amount is included in operating activities in the consolidated statements of cash flows.

Accrued Expenses and Other Current Liabilities

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of:


	December 31,
	2021		2020
Accrued expenses:
Product revenue allowances	26,521		20,917
Selling, general and administrative expenses	6,124		7,385
Research and development expenses	6,857		5,202
Payroll expenses	7,569		9,063
Other	2,057		2,008
Total accrued expenses	49,128		44,575
Other current liabilities:
Lease liability	$	2,094	$	2,108
Total other current liabilities	2,094		2,108
Total accrued expenses and other current liabilities	$	51,222	$	46,683

License Agreements	12 Months Ended
License Agreements	Dec. 31, 2021
Research and Development [Abstract]
License Agreements	License Agreements 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 an exclusive 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, a specified regulatory milestone was met and the Company received a $1,000 milestone payment. The Company does not expect to receive any further payments from Currax under the terms of the License Agreement other than reimbursement for certain expenses. Centessa License Agreement On January 31, 2019, OptiNose AS entered into a licensing agreement with Inexia Limited (the Centessa License Agreement). In February 2021, Inexia merged into Orexia Therapeutics, which became a wholly-owned subsidiary of Centessa Pharmaceuticals (Centessa), a novel asset-centric pharmaceutical company. The Company granted Centessa an exclusive worldwide license to certain intellectual property for the development and commercialization of products containing orexin receptor agonist and/or orexin receptor positive modulator molecules for the treatment, diagnosis or prevention of human diseases or conditions associated primarily with orexin receptor agonist and orexin receptor positive modulation. Under the terms of the Centessa License Agreement, Centessa paid the Company a $500 upfront payment, which was recognized as license revenue during the year ended December 31, 2019. For each product developed under the Centessa License Agreement, the Company is eligible to receive up to $8,000 of development milestone payments and up to $37,000 of sales milestone payments. In addition, the Company is eligible to receive tiered, low-to-mid single digit royalties based on net sales of any products successfully developed and commercialized under the Centessa License Agreement. Other than the upfront payment, the Company does not anticipate the receipt of any milestone or royalty payments from Centessa in the near term.

Long-term Debt

12 Months Ended

Dec. 31, 2021

Debt Disclosure [Abstract]

Long-term Debt

Long-term DebtOn September 12, 2019 (the Closing Date), the Company entered into a 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 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.

In conjunction with the Note Purchase Agreement, the Company paid an upfront fee of $1,125 on the Closing Date and issued warrants to purchase an aggregate of 810,357 shares of Common Stock at an exercise price equal to $6.72 per share, which were set to expire on September 12, 2022. The upfront fees were recorded as a debt discount at issuance and are being amortized to interest expense over the five-year term of the Pharmakon Senior Secured Notes. The Company also incurred $4,991 in debt issuance costs, including $2,404 related to the fair value of the warrants, which were also being amortized to interest expense over the term of the Pharmakon Senior Secured Notes.

On August 13, 2020, the Company entered into a letter agreement (the Pharmakon Letter Agreement) to the Note Purchase Agreement. The Pharmakon Letter Agreement provided the Company with the option to issue additional Pharmakon Senior Secured Notes, subject to the Company achieving specified consolidated XHANCE net sales and royalties for the quarter ended June 30, 2021 and certain other conditions. As consideration for the Pharmakon Letter Agreement, the Company issued 44,643 shares of common stock to Pharmakon. The aggregate fair value of $250 was recorded as debt issuance costs and is being amortized to interest expense over the five-year term of the Pharmakon Senior Secured Notes. The Company was no longer eligible for the additional Pharmakon Senior Secured Notes as the requisite conditions were not satisfied as of June 30, 2021.

On March 2, 2021, the Company entered into the first amendment to the Note Purchase Agreement (the First Amendment) . The First Amendment revised certain minimum trailing twelve-month consolidated XHANCE net sales and royalties the Company is required to achieve. As consideration for the First Amendment, the Company will pay an amendment fee of $1,300 upon the earlier of the prepayment of the Pharmakon Senior Secured Notes or the Maturity Date (defined below). The amendment fee was recorded as a debt issuance cost and is being amortized to interest expense over the term of the Pharmakon Senior Secured Notes.

On November 16, 2021, the Company entered into the second amendment (the Second Amendment) to the Note Purchase Agreement. The Second Amendment revised certain minimum trailing twelve-month consolidated XHANCE net sales and royalties the Company is required to achieve and amended the "make-whole" provision with respect to certain principal prepayments. Upon execution of the Second Amendment, the interest-only period of amounts due under the Note Purchase Agreement were extended from December 2022 to September 2023. Principal repayments will commence on September 15, 2023, with five equal quarterly installments of principal and interest through to the Maturity Date.

In conjunction with 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. The warrants are set to expire on November 18, 2024. The Company cancelled previously issued warrants to purchase an aggregate of 810,357 shares of common stock at an exercise price of $6.72 with an expiration date of September 12, 2022.

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 issuance of the Company's November 16, 2021 financing, 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 Company's assets 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. As of December 31, 2021, the Company was in compliance with the covenants. 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 recorded interest expense of $15,973 and $13,008 during the years ended December 31, 2021 and 2020, respectively. Interest expense included total coupon interest and the amortization of debt issuance costs.

The long-term debt balance is comprised of the following:



	December 31,
	2021		2020
Face amount	$	130,000	$	130,000
Front end fees	(717)		(855)
Debt issuance costs	(4,165)		(3,943)
Back end fees	1,300		—
Long-term debt, net	$	126,418	$	125,202

- 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 http://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 http://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
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI http://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))
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+ Details

Employee Benefit Plans	12 Months Ended
Employee Benefit Plans	Dec. 31, 2021
Retirement Benefits [Abstract]
Employee Benefit Plans	Employee Benefit PlansThe Company maintains a defined contribution 401(k) retirement plan, which covers all eligible US employees. Employees are eligible to participate in the plan on the first of the month following their date of hire. Under the 401(k) retirement plan, participating employees may defer up to 100% of their pre-tax salary, but not more than statutory limits. The Company matches 100% of the first 3% of participating employee contributions and 50% of the next 2% of participating employee contributions, subject to applicable IRC limits. The Company incurred costs of $1,340 and $1,466 related to the Company match applicable to employee contributions for the years ended December 31, 2021 and 2020, respectively. The Company's contributions are made in cash. The Company's common stock is not currently an investment option available to participants in the 401(k) retirement plan. As of December 31, 2021, approximately $280 was recorded in accrued expenses related to the Company match. For Norway employees, the Company maintains a defined contribution pension plan which meets the statutory requirements. The Company maintained a defined contribution pension plan for former UK employees through August 5, 2020. The Company incurred costs of $6 and $18 related to the pension plans for the years ended December 31, 2021 and 2020, respectively.

- Definition

The entire disclosure for retirement benefits.

+ References

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+ Details

Commitments and Contingencies	12 Months Ended
Commitments and Contingencies	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies Purchase commitments As of December 31, 2021, the Company had no material outstanding non-cancellable purchase commitments related to inventory and other goods and services, including pre-commercial manufacturing scale-up and sales and marketing activities. Employment agreements The Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of benefits in the event of termination of employment by the Company without cause or by the employee for good reason. In addition, in the event of termination of employment following a change in control, the vesting of certain equity awards may be accelerated. Litigation Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. The Company is not currently a party to any material pending legal proceedings.

Stockholders' Equity

12 Months Ended

Dec. 31, 2021

Equity [Abstract]

Stockholders' Equity

Common stock

On August 18, 2020, the Company closed an underwritten public offering (the 2020 Offering) of 6,000,000 shares of Common Stock at a price of $5.60 per share. As a result of the 2020 Offering, the Company received $33,401 in net proceeds, after deducting offering expenses of approximately $199 payable by the Company.

On August 13, 2020, in conjunction with the 2020 Offering, the Company entered into a letter agreement to the Pharmakon Senior Secured Notes (the Pharmakon Letter Agreement). As consideration for the Pharmakon Letter Agreement, the Company issued 44,643 shares of Common Stock to Pharmakon. The aggregate fair value of $250 was recorded as debt issuance costs and is being amortized to interest expense over the term of the Pharmakon Senior Secured Notes.

On November 18, 2021, the Company closed an underwritten public offering (the 2021 Offering) of 28,750,000 shares of Company common stock (Common Stock) at a price of $1.60 per share. As a result of the Offering, the Company received $42,842 in net proceeds, after deducting commissions and expenses of $2,860 and offering costs payable by The Company of $298.

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Subject to preferences that may apply to any outstanding preferred stock, holders of common stock are entitled to receive ratably any dividends that the Company’s board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. No dividends had been declared through December 31, 2021.

Common stock warrants

On November 18, 2021, in conjunction with 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.

The grant date fair value of the warrants issued in connection with the Pharmakon Senior Secured Notes was estimated at the time of grant using the Black-Scholes option-pricing model using the following weighted average assumptions:


Risk free interest rate	0.87		%
Expected term (in years)	3
Expected volatility	78.25		%
Annual dividend yield	0.00		%
Fair value of common stock	$	1.60

As of December 31, 2021, 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 15, 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

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Abstract]

Stock-based Compensation

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 A&R Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, deferred stock units, performance shares, stock appreciation rights and other equity-based awards. The Company's employees, officers, directors and other persons are eligible to receive awards under the A&R Plan. As of December 31, 2021, 14,009,728 shares of the Company's common stock were authorized to be issued under the A&R Plan, and 1,856,874 shares were reserved for future awards under the A&R Plan. The number of shares of the Company's common stock authorized under the A&R Plan will automatically increase on January 1st of each year until the expiration of the A&R Plan, in an amount equal to four percent of the total number of shares of the Company's common stock outstanding on December 31st of the preceding calendar year, subject to the discretion of the Company's board of directors or compensation committee to determine a lesser number of shares shall be added for such year.

The amount, terms of grants, and exercisability provisions are determined and set by the Company's board of directors or compensation committee. The Company measures employee stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. Stock-based awards issued to non-employees are revalued until the award vests.

Stock options

The Company has issued service-based and performance-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 board of directors. Vesting generally occurs over a period of not greater than four years. Performance-based options may vest upon the achievement of certain milestones in connection with the Company's development programs. Additionally, the Company has issued stock options in excess of the fair market value of Common Stock on the issuance date that were only exercisable upon a change in control or upon or after an initial public offering. As of December 31, 2021, all of the performance conditions related to performance-based stock options issued by the Company have been achieved.

The following table summarizes the activity related to stock option grants to employees and non-employees for the year ended December 31, 2021:


	Shares	Weighted average exercise price per share		Weighted average remaining contractual life
Outstanding at December 31, 2020	6,852,733	$	10.34	6.84
Granted	1,741,954	3.35
Exercised	(23,879)	1.63
Expired	(334,628)	12.28
Forfeited	(277,399)	7.62
Outstanding at December 31, 2021	7,958,781	$	8.87	6.50
Exercisable at December 31, 2021	5,210,833	$	11.09	5.35
Vested and expected to vest at December 31, 2021	7,958,781	$	8.87	6.50

During the year ended December 31, 2021, stock options to purchase 1,741,954 shares of common stock were granted to employees that generally vest over four years. The options had an estimated weighted average grant date fair value of $2.18. The grant date fair value of each option grant was estimated at the time of grant using the Black-Scholes option-pricing model.

The total aggregate intrinsic value of stock options exercised during the years ended December 31, 2021 and 2020 was $35 and $3,520, respectively. The aggregate intrinsic value of stock options outstanding as of December 31, 2021 was $1. As of December 31, 2021, no exercisable stock options had intrinsic value. At December 31, 2021, the unrecognized compensation cost related to unvested stock options expected to vest was $7,224. This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.2 years.

Included in the table above are 253,500 options 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).

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 year ended December 31, 2021:


			Shares
Balance at December 31, 2020			1,491,589
Granted			957,990
Vested and settled			(383,631)
Expired/forfeited/canceled			(106,590)
Balance at December 31, 2021			1,959,358
Expected to vest at December 31, 2021			1,959,358

During the year ended December 31, 2021, the Company granted 957,990 RSUs at a weighted-average grant date fair value of $3.51, all of which were service-based RSUs. No performance-based RSUs were granted in 2021. As of December 31, 2021, the milestones associated with the performance based-RSUs were not probable of achievement, and accordingly, no stock-based compensation expense has been recognized to date for these awards. At December 31, 2021, the unrecognized compensation cost related to unvested service-based RSUs expected to vest was $4,819, to be recognized over an estimated weighted-average amortization period of 2.60 years. The unrecognized compensation cost related to unvested performance-based RSUs was $3,095, which will be recognized commencing in the period in which the performance condition is deemed probable of achievement 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

The Company's 2017 Employee Stock Purchase Plan (the 2017 Plan) became effective on October 12, 2017. As of December 31, 2021, 1,199,424 shares of the Company's common stock were authorized to be issued pursuant to purchase rights granted to its employees or to employees of any of its participating affiliates under the 2017 Plan. 488,465 shares of the Company's common stock were reserved for future issuance under the 2017 Plan. The number of shares of the Company's common stock that may be issued pursuant to rights granted under the 2017 Plan shall automatically increase on January 1st of each year until the expiration of the 2017 Plan, in an amount equal to one percent of the total number of shares of the Company's common stock outstanding on December 31st

of the preceding calendar year, subject to the discretion of the board of directors or compensation committee to determine a lesser number of shares shall be added for such year.

Under the 2017 Plan, eligible employees can purchase the Company’s common stock through accumulated payroll deductions at such times as are established by the administrator. The 2017 Plan is administered by the compensation committee. Eligible employees may contribute up to 15% of their eligible compensation. A participant may not accrue rights to purchase more than $25 worth of the Company’s common stock for each calendar year in which such right is outstanding.

Payroll withholdings accumulate during the following six month offering periods each calendar year while the Purchase Plan is effective:

•January 1 through June 30, and

•July 1 through December 31.

At the end of each offering period, shares of the Company’s common stock may be purchased at 85% of the lesser of the average of the high and low sales price of the Company’s common stock on (i) the first trading day of the relevant offering period and (ii) the last trading day of the relevant offering period (or, if the relevant offering period has multiple purchase periods, the last trading day of the relevant purchase period). In accordance with the guidance in ASC 718-50 – Compensation – Stock Compensation, the ability to purchase shares of the Company’s common stock at the lower of the price on the first day of the offering period or the last day of the offering period (i.e. the purchase date) represents an option and, therefore, the 2017 Plan is a compensatory plan under this guidance. Accordingly, stock-based compensation expense is determined based on the option’s grant-date fair value as estimated by applying the Black-Scholes option-pricing model and is recognized over the requisite service period of the option. The Company has recognized stock-based compensation expense of $402 and $480 during the years ended December 31, 2021 and 2020, respectively, related to the 2017 Plan.

Stock-based compensation expense

The Company recorded stock-based compensation expense in the following expense categories of its accompanying consolidated statements of operations for the years ended December 31, 2021 and 2020:


	Year Ended December 31,
	2021		2020
Cost of product sales	$	50	$	129
Research and development	1,079		1,241
Selling, general and administrative	8,874		8,979
Total stock-based compensation expense	$	10,003	$	10,349

In addition, stock-based compensation expense of $84 was charged to inventory as of December 31, 2021. These charges represent the total stock-based compensation expense incurred related to employees involved in the manufacturing process of finished goods and samples during the period.

The Company utilized the Black-Scholes valuation model for estimating the fair value of stock options and restricted stock units issued under 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:


	December 31, 2021
	2010 A&R Stock Incentive Plan		2017 Employee Stock Purchase Plan
Risk free interest rate	1.02	%	0.07	%
Expected term (in years)	6.08		0.50
Expected volatility	74.11	%	65.43	%
Annual dividend yield	0.00	%	0.00	%

Option valuation methods, including Black-Scholes, require the input of subjective assumptions, which are discussed below.

•The expected term of employee options is determined using the "simplified" method, as prescribed in SEC's Staff Accounting Bulletin (SAB) No. 107, Share Based Payment (SAB No. 107), whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company's lack of sufficient historical data. The expected term of non-employee options is equal to the contractual term.

•The expected volatility is based on a weighted average of the Company's historical volatility and the volatilities of similar entities within the Company's industry which were commensurate with the expected term assumption as described in SAB No. 107.

•The risk-free interest rate is based on the interest rate payable on US Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term.

•The expected dividend yield is 0% because the Company has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock.

Income Taxes

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Income Taxes

Income taxes are based on the following book income (loss) before income tax expense:


	Year Ended December 31,
	2021		2020
Domestic operations	$	(78,801)	$	(93,849)
Foreign operations	(3,495)		(5,936)
Loss before provision for income taxes	$	(82,296)	$	(99,785)

A reconciliation of income tax expense (benefit) at the US federal statutory income tax rate and the income tax provision in the financial statements is as follows:


	Year Ended December 31,
	2021		2020
Income tax expense at statutory rate	21.0	%	21.0	%
Permanent items	(0.4)		0.3
Foreign rate differential	0.1		0.1
Impact of foreign operations	—		—
State taxes, net of federal benefit	4.7		4.7
Tax rate changes	—		0.1
Foreign exchange and other	(0.9)		(0.2)
Change in valuation allowance	(24.5)		(26.0)
Effective income tax rate	0.0	%	0.0	%

The principal components of the Company’s deferred tax assets and liabilities are as follows:


	Year Ended December 31,
	2021		2020
Deferred tax assets:
Accrued expenses and other	$	6,712	$	5,062
Prepaid licensing arrangement	9,441		10,251
Interest expense	10,708		7,141
Stock compensation	8,583		6,819
Lease liability	1,081		1,551
Research and development credits	2,461		2,485
Net operating losses	87,324		73,278
Total deferred tax assets	126,310		106,587
Deferred tax liabilities:
Fixed assets, including leases	(210)		(220)
Right-to-use asset	(1,024)		(1,479)
Total deferred tax liabilities:	(1,234)		(1,699)
Less: Valuation allowance	(125,076)		(104,888)
Total net deferred tax assets (liabilities)	$	—	$	—

As of December 31, 2021, the Company had foreign net operating loss (NOL) carry forwards of $63,920 primarily from its operations in Norway. As of December 31, 2021, the Company had federal and state NOLs of $294,101 and $231,765, respectively. These domestic NOL carry forwards may be subject to an annual limitation in the event of cumulative changes in the ownership interests of significant stockholders over a three-year period in excess of 50%. This could limit the amount of NOLs that the Company can utilize annually to offset future domestic taxable income, if any. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The federal NOLs generated after 2017 have an indefinite carry forward period. The federal NOLs generated prior to 2018 will expire from 2030 through 2037. Some state NOLs will not expire while other state NOLs expire over various periods depending on the rules of the jurisdiction in which they were generated. The earliest state NOL expiration is in 2030.

Our U.S. NOL and tax credit carry forwards could expire unused and be unavailable to offset future income tax liabilities because of their limited duration or because of other restrictions under U.S. tax law. Under Sections 382 and 383, if a corporation undergoes an “ownership change”, generally defined as a greater than 50% change, by value, in equity ownership during a three-year period, the corporation’s ability to offset pre-change tax attributes, such as NOLs and R&D tax credits, against post-change income or tax may be limited. We have not performed an analysis under Section 382 and cannot predict or otherwise determine whether utilization of our federal tax attribute carry forwards may be limited. As a result, if we have taxable income in the future, our ability to use existing U.S. NOL and R&D tax credit carry forwards to reduce U.S. taxable income or tax liability may be subject to limitation resulting in increased future tax liabilities. Similar rules at the state level may also limit our ability to use state NOLs. Also, there may be periods when the use of NOLs is suspended or otherwise limited at the state level, which could accelerate or permanently increase state taxes owed.

The company also has federal and state R&D credit carryforwards of $2,487 which can be carried forward for 20 years beginning to expire in 2031.

ASC 740 requires the establishment of a valuation allowance to reduce deferred tax assets if, based on the weight of the available positive and negative evidence it is more likely than not that all or a portion of the deferred tax

assets will not be realized. There is insufficient positive evidence to overcome the negative evidence attributable to the Company’s cumulative operating losses. Consequently, the Company established a full valuation allowance against its net deferred tax assets at December 31, 2021 and 2020, respectively, because the Company’s management was unable to conclude that it is more likely than not that these assets will be fully realized. The Company had a net increase in its valuation allowance of $20,188 during the year ended December 31, 2021.

The Company files income tax returns in Norway, the UK, the US, and various states. The Company is subject to examination by federal, state and foreign jurisdictions. The Company’s tax years in the US are open under statute from inception to present. All open years may be examined to the extent that tax credits or net operating loss carry forwards are used in future periods.

The Company’s policy is to record interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2021, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statement of operations.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted into law in response to the COVID-19 pandemic. The CARES Act contains income tax provisions, such an enhanced interest deductibility, repeal of the 80% limitation with respect to net operating losses arising in taxable years 2018-2020, and additional depreciation deductions related to qualified improvement property. The Company has concluded the analysis of these provisions as of year-end and the CARES Act did not have a material impact on the Company’s income taxes for 2021.

On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA) was signed into law. Along with providing funding for normal government operations ($1.4 trillion), this bill provides for additional COVID-19 focused relief ($900 billion). The CAA extends certain provisions of the CARES Act, provides additional funding for others and contains new relief provisions. The company CAA did not have a material impact on the Company’s income taxes for 2021.

- 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
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Basis of presentation

Principles of consolidation

Use of estimates

Concentration of credit risk

Cash and cash equivalents

Cash and cash equivalentsAll highly liquid investments purchased with an original maturity date of three months or less at the date of purchase are considered to be cash equivalents. The Company maintains its cash and cash equivalent balances at foreign and domestic financial institutions.

Restricted cash

Restricted cashAs of December 31, 2021 and 2020, the restricted cash balance included in prepaid expenses and other assets was $13 and $23, respectively.

Fair value of financial instruments

•Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

•Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement.

Accounts receivable

Inventory

Inventory Inventories are stated at the lower of cost or net realizable value. Costs of inventories, which include amounts related to materials and manufacturing overhead, are determined on a first-in, first-out basis. An assessment of the recoverability of capitalized inventory is performed during each reporting period and any excess and obsolete inventories are written down to their estimated net realizable value in the period in which the impairment is first identified.

Property and equipment

The estimated useful lives of property and equipment are as follows:

Computer equipment

2-3 years

Software

3 years

Machinery & production equipment

5-10 years

Furniture & fixtures

3-5 years

Leasehold improvements

Shorter of lease term or useful life

Long lived assets

Long lived assetsLong-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell.

Net product revenues and licensing revenues

Net product revenues

Transaction Price, including Estimates of Variable Consideration

Licensing Revenues

Advertising expenses

Advertising expensesThe Company expenses the costs of advertising, including promotional expenses, as incurred.

Research and development

Stock-based compensation

Income taxes

Income taxesIncome taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on the weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized.

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 common stockholders by the weighted average common shares outstanding during the period.

Recent accounting pronouncements

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Schedule of Property and Equipment Useful Lives

The estimated useful lives of property and equipment are as follows:

Computer equipment

2-3 years

Software

3 years

Machinery & production equipment

5-10 years

Furniture & fixtures

3-5 years

Leasehold improvements

Shorter of lease term or useful life

Property and equipment, net, consisted of:


	December 31,
	2021		2020
Computer equipment and software	$	1,173	$	1,128
Furniture and fixtures	366		366
Machinery and equipment	3,367		3,440
Leasehold improvements	609		609
Construction in process	115		271
	5,630		5,814
Less: accumulated depreciation	(4,283)		(3,786)
	$	1,347	$	2,028

Schedule of Antidilutive Shares Excluded from Earnings Per Share

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


	Year Ended December 31,
	2021	2020
Stock options	7,958,781	6,852,733
Restricted stock units	1,959,358	1,491,589
Common stock warrants	2,500,000	810,357

Total	12,418,139	9,154,679

Inventory (Tables)

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventory consisted of the following:


	December 31,
	2021		2020
Raw materials	$	3,504	$	2,669
Work-in-process	4,816		2,676
Finished goods	3,527		3,697
Total inventory	$	11,847	$	9,042

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment, Net

The estimated useful lives of property and equipment are as follows:

Computer equipment

2-3 years

Software

3 years

Machinery & production equipment

5-10 years

Furniture & fixtures

3-5 years

Leasehold improvements

Shorter of lease term or useful life

Property and equipment, net, consisted of:


	December 31,
	2021		2020
Computer equipment and software	$	1,173	$	1,128
Furniture and fixtures	366		366
Machinery and equipment	3,367		3,440
Leasehold improvements	609		609
Construction in process	115		271
	5,630		5,814
Less: accumulated depreciation	(4,283)		(3,786)
	$	1,347	$	2,028

Leases (Tables)

12 Months Ended

Dec. 31, 2021

Leases [Abstract]

Schedule of Lease Assets, Liabilities, Term and Discount Rate

The table below presents the operating lease assets and liabilities recognized on the Company's consolidated balance sheets:


	Balance Sheet Line Item	December 31, 2021		December 31, 2020
Non-current operating lease assets	Other assets	$	4,051	$	5,978
Operating lease liabilities:
Current operating lease liabilities	Accrued expenses and other current liabilities	2,094		2,108
Non-current operating lease liabilities	Other liabilities	2,190		4,161
Total operating lease liabilities		$	4,284	$	6,269

The Company's weighted average remaining lease term and weighted average discount rate for operating leases as of December 31, 2021 are:


	December 31, 2021
Weighted average remaining lease term (years)	2.09
Weighted average discount rate	4.55	%

Schedule of Operating Lease Liability Maturities


	December 31, 2021
2022	$	2,461
2023	1,831
2024	424
Thereafter	—
Total undiscounted future minimum lease payments	4,716
Less: difference between undiscounted lease payments and discounted operating lease liabilities	432
Total operating lease liabilities	$	4,284

Accrued Expenses and Other Current Liabilities (Tables)

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Schedule of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of:


	December 31,
	2021		2020
Accrued expenses:
Product revenue allowances	26,521		20,917
Selling, general and administrative expenses	6,124		7,385
Research and development expenses	6,857		5,202
Payroll expenses	7,569		9,063
Other	2,057		2,008
Total accrued expenses	49,128		44,575
Other current liabilities:
Lease liability	$	2,094	$	2,108
Total other current liabilities	2,094		2,108
Total accrued expenses and other current liabilities	$	51,222	$	46,683

Long-Term Debt (Tables)

12 Months Ended

Dec. 31, 2021

Debt Disclosure [Abstract]

Schedule of Long-term Debt Instruments

The long-term debt balance is comprised of the following:



	December 31,
	2021		2020
Face amount	$	130,000	$	130,000
Front end fees	(717)		(855)
Debt issuance costs	(4,165)		(3,943)
Back end fees	1,300		—
Long-term debt, net	$	126,418	$	125,202

- 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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-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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+ Details

Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2021

Equity [Abstract]

Schedule of Grant Date Fair Value of Warrant, Valuation Assumptions


Risk free interest rate	0.87		%
Expected term (in years)	3
Expected volatility	78.25		%
Annual dividend yield	0.00		%
Fair value of common stock	$	1.60

Schedule of Warrants Outstanding

As of December 31, 2021, 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 15, 2024

Stock-based Compensation (Tables)

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Abstract]

Schedule of Stock Option Activity

The following table summarizes the activity related to stock option grants to employees and non-employees for the year ended December 31, 2021:


	Shares	Weighted average exercise price per share		Weighted average remaining contractual life
Outstanding at December 31, 2020	6,852,733	$	10.34	6.84
Granted	1,741,954	3.35
Exercised	(23,879)	1.63
Expired	(334,628)	12.28
Forfeited	(277,399)	7.62
Outstanding at December 31, 2021	7,958,781	$	8.87	6.50
Exercisable at December 31, 2021	5,210,833	$	11.09	5.35
Vested and expected to vest at December 31, 2021	7,958,781	$	8.87	6.50

Schedule of Restricted Stock Unit Activity

The following table summarizes the activity related to RSUs granted to employees for the year ended December 31, 2021:


			Shares
Balance at December 31, 2020			1,491,589
Granted			957,990
Vested and settled			(383,631)
Expired/forfeited/canceled			(106,590)
Balance at December 31, 2021			1,959,358
Expected to vest at December 31, 2021			1,959,358

Schedule of Allocated Stock-based Compensation Expense

The Company recorded stock-based compensation expense in the following expense categories of its accompanying consolidated statements of operations for the years ended December 31, 2021 and 2020:


	Year Ended December 31,
	2021		2020
Cost of product sales	$	50	$	129
Research and development	1,079		1,241
Selling, general and administrative	8,874		8,979
Total stock-based compensation expense	$	10,003	$	10,349

Schedule of Fair Value Options using Black-Scholes Pricing Model

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:


	December 31, 2021
	2010 A&R Stock Incentive Plan		2017 Employee Stock Purchase Plan
Risk free interest rate	1.02	%	0.07	%
Expected term (in years)	6.08		0.50
Expected volatility	74.11	%	65.43	%
Annual dividend yield	0.00	%	0.00	%

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Schedule of Income (Loss) Before Income Tax, Domestic and Foreign

Income taxes are based on the following book income (loss) before income tax expense:


	Year Ended December 31,
	2021		2020
Domestic operations	$	(78,801)	$	(93,849)
Foreign operations	(3,495)		(5,936)
Loss before provision for income taxes	$	(82,296)	$	(99,785)

Schedule of Effective Income Tax Rate Reconciliation

A reconciliation of income tax expense (benefit) at the US federal statutory income tax rate and the income tax provision in the financial statements is as follows:


	Year Ended December 31,
	2021		2020
Income tax expense at statutory rate	21.0	%	21.0	%
Permanent items	(0.4)		0.3
Foreign rate differential	0.1		0.1
Impact of foreign operations	—		—
State taxes, net of federal benefit	4.7		4.7
Tax rate changes	—		0.1
Foreign exchange and other	(0.9)		(0.2)
Change in valuation allowance	(24.5)		(26.0)
Effective income tax rate	0.0	%	0.0	%

Schedule of Deferred Tax Assets and Liabilities

The principal components of the Company’s deferred tax assets and liabilities are as follows:


	Year Ended December 31,
	2021		2020
Deferred tax assets:
Accrued expenses and other	$	6,712	$	5,062
Prepaid licensing arrangement	9,441		10,251
Interest expense	10,708		7,141
Stock compensation	8,583		6,819
Lease liability	1,081		1,551
Research and development credits	2,461		2,485
Net operating losses	87,324		73,278
Total deferred tax assets	126,310		106,587
Deferred tax liabilities:
Fixed assets, including leases	(210)		(220)
Right-to-use asset	(1,024)		(1,479)
Total deferred tax liabilities:	(1,234)		(1,699)
Less: Valuation allowance	(125,076)		(104,888)
Total net deferred tax assets (liabilities)	$	—	$	—

Liquidity (Details) - USD ($) $ / shares in Units, $ in Thousands	Nov. 18, 2021	Aug. 18, 2020	Dec. 31, 2021	Dec. 31, 2020
Subsidiary, Sale of Stock [Line Items]
Cash and cash equivalents			$ 110,502	$ 144,156
Public Offering
Subsidiary, Sale of Stock [Line Items]
Number of shares issued (in shares)	28,750,000	6,000,000
Price per share (in dollars per share)	$ 1.60	$ 5.60
Consideration received on transaction	$ 42,842	$ 33,401
Fees and commissions	2,860
Deferred offering costs	$ 298	$ 199

Summary of Significant Accounting Policies - Concentration risk (Details) - Customer Concentration Risk - Five Customers	12 Months Ended
	Dec. 31, 2021
Accounts Receivable
Concentration Risk [Line Items]
Concentration risk	36.00%
Sales Revenue, Net
Concentration Risk [Line Items]
Concentration risk	31.00%

Summary of Significant Accounting Policies - Cash and cash equivalents and restricted cash (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Disaggregation of Revenue [Line Items]
Cash, uninsured amount	$ 109,017	$ 141,944
Prepaid Expenses and Other Current Assets
Disaggregation of Revenue [Line Items]
Restricted cash	$ 13	$ 23

Summary of Significant Accounting Policies - Accounts receivable (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Allowance for doubtful accounts	$ 444	$ 677

Summary of Significant Accounting Policies - Property and equipment (Details)	12 Months Ended
	Dec. 31, 2021
Computer equipment \| Minimum
Property, Plant and Equipment [Line Items]
Useful life	2 years
Computer equipment \| Maximum
Property, Plant and Equipment [Line Items]
Useful life	3 years
Software
Property, Plant and Equipment [Line Items]
Useful life	3 years
Machinery & production equipment \| Minimum
Property, Plant and Equipment [Line Items]
Useful life	5 years
Machinery & production equipment \| Maximum
Property, Plant and Equipment [Line Items]
Useful life	10 years
Furniture & fixtures \| Minimum
Property, Plant and Equipment [Line Items]
Useful life	3 years
Furniture & fixtures \| Maximum
Property, Plant and Equipment [Line Items]
Useful life	5 years

Summary of Significant Accounting Policies - Long lived assets (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Impairment or disposition of long-lived assets	$ 0	$ 0

Summary of Significant Accounting Policies - Licensing revenues (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Disaggregation of Revenue [Line Items]
Total revenues	$ 74,652	$ 49,117
Licensing revenues
Disaggregation of Revenue [Line Items]
Total revenues	$ 1,000	$ 750

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Summary of Significant Accounting Policies - Advertising expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Advertising expense	$ 15,638	$ 15,015

Summary of Significant Accounting Policies - Net income (loss) per common share (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securites excluded from computation of earnings per share (in shares)	12,418,139	9,154,679
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securites excluded from computation of earnings per share (in shares)	7,958,781	6,852,733
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securites excluded from computation of earnings per share (in shares)	1,959,358	1,491,589
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Securites excluded from computation of earnings per share (in shares)	2,500,000	810,357

Inventory (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Inventory Disclosure [Abstract]
Raw materials	$ 3,504	$ 2,669
Work-in-process	4,816	2,676
Finished goods	3,527	3,697
Total inventory	$ 11,847	$ 9,042

Property and Equipment (Details) - USD ($) $ in Thousands	12 Months Ended
Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 5,630	$ 5,814
Less: accumulated depreciation	(4,283)	(3,786)
Property and equipment, net	1,347	2,028
Depreciation	645	1,454
Computer equipment and software
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,173	1,128
Furniture & fixtures
Property, Plant and Equipment [Line Items]
Property and equipment, gross	366	366
Machinery & production equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	3,367	3,440
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	$ 271
Inventories
Property, Plant and Equipment [Line Items]
Depreciation	576
Prepaid Expenses and Other Current Assets
Property, Plant and Equipment [Line Items]
Depreciation	$ 4

Leases - Narrative (Details) - USD ($)	12 Months Ended
Leases - Narrative (Details) - USD ($)	Dec. 31, 2021	Dec. 31, 2020	Jan. 01, 2019
Lessee, Lease, Description [Line Items]
Operating lease assets			$ 2,411,000
Total operating lease liabilities	$ 4,284,000	$ 6,269,000
Option to renew, extension of lease term	0
Operating lease costs	2,843,000	2,770,000
Cash paid for amounts included in the measurement of operating lease liabilities	$ 2,466,000	$ 857,000
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]	Other assets	Other assets	Other assets
Accounts Payable and Other Accrued Liabilities, Current, and Other Noncurrent Liabilities
Lessee, Lease, Description [Line Items]
Total operating lease liabilities			$ 2,887,000

Leases - Operating lease assets and liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020	Jan. 01, 2019
Leases [Abstract]
Non-current operating lease assets	$ 4,051	$ 5,978
Operating lease liabilities:
Current operating lease liabilities	2,094	2,108
Non-current operating lease liabilities	2,190	4,161
Total operating lease liabilities	$ 4,284	$ 6,269
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]	Other assets	Other assets	Other assets
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Accrued expenses	Accrued expenses
Operating Lease, Liability, Statement of Financial Position [Extensible List]	Other liabilities	Other liabilities

Leases - Weighted average remaining lease term and weighted average discount rate (Details)	Dec. 31, 2021
Leases [Abstract]
Weighted average remaining lease term (years)	2 years 1 month 2 days
Weighted average discount rate	4.55%

Leases - Operating lease maturities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Operating leases
2022	$ 2,461
2023	1,831
2024	424
Thereafter	0
Total undiscounted future minimum lease payments	4,716
Less: difference between undiscounted lease payments and discounted operating lease liabilities	432
Total operating lease liabilities	$ 4,284	$ 6,269

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Accrued expenses:
Product revenue allowances	$ 26,521	$ 20,917
Selling, general and administrative expenses	6,124	7,385
Research and development expenses	6,857	5,202
Payroll expenses	7,569	9,063
Other	2,057	2,008
Total accrued expenses	49,128	44,575
Other current liabilities:
Lease liability	2,094	2,108
Total other current liabilities	2,094	2,108
Total accrued expenses and other current liabilities	$ 51,222	$ 46,683

License Agreements (Details) - USD ($) $ in Thousands		1 Months Ended	12 Months Ended
License Agreements (Details) - USD ($) $ in Thousands	Dec. 29, 2020	Jan. 31, 2021	Dec. 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
Inexia License Agreement
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Upfront payment received				$ 500
Sales milestone payments eligible to be received (up to)			$ 37,000
Development milestone payments eligible to be received (up to)			$ 8,000

Long-term Debt - Narrative (Details)			3 Months Ended	12 Months Ended
Long-term Debt - Narrative (Details)	Aug. 13, 2020 USD ($) shares	Sep. 12, 2019 USD ($) $ / shares shares	Sep. 30, 2020 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)	Nov. 18, 2021 USD ($) $ / shares shares	Mar. 02, 2021 USD ($)	Dec. 01, 2020 USD ($)	Feb. 13, 2020 USD ($)
Debt Instrument [Line Items]
Debt issuance costs								$ 1,300,000
Warrants Expiring November 18, 2024
Debt Instrument [Line Items]
Number of shares called by warrants (in shares) \| shares							2,500,000
Warrants outstanding, measurement input							1.60
Warrants and rights outstanding							$ 2,009
Warrants Expiring September 12, 2022
Debt Instrument [Line Items]
Number of shares called by warrants (in shares) \| shares							810,357
Common stock warrant exercise price (in dollars per share) \| $ / shares							$ 6.72
Senior Notes \| Note Purchase Agreement
Debt Instrument [Line Items]
Debt maximum borrowing capacity		$ 130,000,000
Face amount		80,000,000
Debt upfront fee		$ 1,125,000
Number of shares called by warrants (in shares) \| shares		810,357
Common stock warrant exercise price (in dollars per share) \| $ / shares		$ 6.72
Debt term	5 years	5 years
Debt issuance costs		$ 4,991,000
Debt issuance costs, fair vale of the warrants		$ 2,404,000
Prepayment fee, after second and before third anniversary		0.02
Prepayment fee, after third and before fourth anniversary		0.01
Prepayment premium amount		$ 0
Covenant, cash and cash equivalents		$ 30,000,000
Interest expense, debt				$ 15,973,000	$ 13,008,000
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]
Face amount										$ 30,000,000
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						$ 9,000,000
Senior Notes \| Note Purchase Agreement - Third Delayed Draw Notes
Debt Instrument [Line Items]
Face amount									$ 20,000,000
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			$ 14,500,000
Senior Notes \| Note Purchase Agreement Additional Delayed Draw Notes
Debt Instrument [Line Items]
Debt issuance costs	$ 250,000
Issuance of common stock in connection with Pharmakon Amendment (in shares) \| shares	44,643

Long-term Debt - Schedule of long term debt (Details) - Senior Notes - Note Purchase Agreement - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Debt Instrument [Line Items]
Face amount	$ 130,000	$ 130,000
Front end fees	(717)	(855)
Debt issuance costs	(4,165)	(3,943)
Back end fees	1,300	0
Long-term Debt	$ 126,418	$ 125,202

- Definition

Amount, after unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations.

+ References + Details

Employee Benefit Plans (Details) - USD ($) $ in Thousands	12 Months Ended
Employee Benefit Plans (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Defined Contribution Plan Disclosure [Line Items]
Maximum annual contributions per employee	100.00%
Accrued expenses related to the Company match	$ 280
Defined contribution plan, cost	1,340	$ 1,466
Foreign Plan
Defined Contribution Plan Disclosure [Line Items]
Defined contribution plan, cost	$ 6	$ 18
Defined Contribution Plan, Tranche One
Defined Contribution Plan Disclosure [Line Items]
Maximum annual contributions per employee	3.00%
Employer matching contribution	100.00%
Defined Contribution Plan, Tranche Two
Defined Contribution Plan Disclosure [Line Items]
Maximum annual contributions per employee	2.00%
Employer matching contribution	50.00%

Commitments and Contingencies (Details)	Dec. 31, 2021 USD ($)
Commitments and Contingencies Disclosure [Abstract]
Purchase obligation	$ 0

Stockholders' Equity - Narrative (Details)				12 Months Ended
Stockholders' Equity - Narrative (Details)	Nov. 18, 2021 USD ($) $ / shares shares	Aug. 18, 2020 USD ($) $ / shares shares	Aug. 13, 2020 USD ($) shares	Dec. 31, 2021 vote $ / shares
Class of Stock [Line Items]
Vote per share \| vote				1
Dividends declared (in dollars per share) \| $ / shares				$ 0
Warrants Expiring November 15, 2024
Class of Stock [Line Items]
Number of shares called by warrants (in shares) \| shares	2,500,000
Warrants and rights outstanding \| $	$ 2,009
Common stock warrant exercise price (in dollars per share) \| $ / shares				$ 1.60
Warrants Expiring September 12, 2022
Class of Stock [Line Items]
Number of shares called by warrants (in shares) \| shares	810,357
Common stock warrant exercise price (in dollars per share) \| $ / shares	$ 6.72
Note Purchase Agreement Additional Delayed Draw Notes \| Senior Notes
Class of Stock [Line Items]
Issuance of common stock in connection with Pharmakon Amendment (in shares) \| shares			44,643
Debt issuance costs \| $			$ 250,000
Public Offering
Class of Stock [Line Items]
Number of shares issued (in shares) \| shares	28,750,000	6,000,000
Price per share (in dollars per share) \| $ / shares	$ 1.60	$ 5.60
Consideration received on transaction \| $	$ 42,842,000	$ 33,401,000
Deferred offering costs \| $	$ 298,000	$ 199,000

Stockholders' Equity - Grant date fair value of warrants, valuation assumptions (Details)	Dec. 31, 2021	Nov. 18, 2021
Risk free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants outstanding, measurement input		0.0087
Expected term (in years)
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants outstanding, measurement input		3
Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants outstanding, measurement input		0.7825
Annual dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants outstanding, measurement input		0.0000
Fair value of common stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants outstanding, measurement input	1.60

Stockholders' Equity - Warrants Outstanding (Details) - Warrants Expiring November 15, 2024	Dec. 31, 2021 $ / shares shares
Class of Stock [Line Items]
Number of warrants outstanding (in shares) \| shares	2,500,000
Common stock warrant exercise price (in dollars per share) \| $ / shares	$ 1.60

Stock-based Compensation - Narrative (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 10,003,000	$ 10,349,000
Maximum annual contributions per employee	100.00%
Expected dividend yield	0.00%
Inventories
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 84,000
Service Based Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Award vesting period	4 years
Granted (in shares)	1,741,954
Fair value of common stock (in dollars per share)	$ 2.18
Intrinsic value of exercised options	$ 35,000	3,520,000
Intrinsic value of options outstanding	1,000
Unrecognized compensation cost	$ 7,224,000
Unrecognized compensation, estimated weighted-average amortization period	2 years 2 months 12 days
Restricted stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Award vesting period	4 years
Shares issued (in shares)	957,990
Price issued (in dollars per share)	$ 3.51
Restricted Stock Units, Service-Based
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation cost	$ 4,819,000
Unrecognized compensation, estimated weighted-average amortization period	2 years 7 months 6 days
Restricted Stock Units, Performance-Based
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation cost	$ 3,095,000
Stock-based compensation expense	$ 0
Amended and Restated Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares authorized under plan (shares)	14,009,728
Number of shares reserved for future issuance under plan (shares)	1,856,874
Yearly increase in shares reserved for future issuance	4.00%
Plan options contractual life	10 years
Award vesting period	4 years
2017 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares authorized under plan (shares)	1,199,424
Number of shares reserved for future issuance under plan (shares)	488,465
Stock-based compensation expense	$ 402,000	$ 480,000
Increase in number of shares issuable each year	1.00%
Maximum annual contributions per employee	15.00%
Maximum employee accrued rights to purchase common stock (in dollars per share)	$ 25
Purchase price of common stock percent	85.00%
Expected dividend yield	0.00%
NASDAQ Inducement Grant Exception \| Service Based Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)	253,500
NASDAQ Inducement Grant Exception \| Restricted stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares issued (in shares)	60,000

Stock-based Compensation - Service-based stock options (Details) - Service Based Stock Options - $ / shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Service-based stock options activity
Shares outstanding, beginning (in shares)	6,852,733
Granted (in shares)	1,741,954
Exercised (in shares)	(23,879)
Expired (in shares)	(334,628)
Forfeited (in shares)	(277,399)
Shares outstanding, ending (in shares)	7,958,781	6,852,733
Exercisable at end of period (in shares)	5,210,833
Vested and expected to vest at end of period (in shares)	7,958,781
Service-based stock options weighted average exercise price
Beginning balance, Weighted average exercise price (in dollars per share)	$ 10.34
Granted, Weighted average exercise price (in dollars per share)	3.35
Exercised, Weighted average exercise price (in dollars per share)	1.63
Expired, Weighted average exercise price (in dollars per share)	12.28
Forfeited, Weighted average exercise price (in dollars per share)	7.62
Ending balance, Weighted average exercise price (in dollars per share)	8.87	$ 10.34
Options exercisable, Weighted average exercise price per share (in dollars per share)	11.09
Vested and expected to vest, Weighted average exercise price per share (in dollars per share)	$ 8.87
Service-based stock options, additional disclosures
Options outstanding, Weighted average remaining contractual life	6 years 6 months	6 years 10 months 2 days
Options exercisable, Weighted average remaining contractual life	5 years 4 months 6 days
Vested and expected to vest, Weighted average remaining contractual life	6 years 6 months

Stock-based Compensation - Schedule of RSUs (Details) - Restricted stock units	12 Months Ended
	Dec. 31, 2021 shares
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Balance at beginning (in shares)	1,491,589
Shares issued (in shares)	957,990
Vested and settled (in shares)	(383,631)
Expired/ forfeited/ canceled (in shares)	(106,590)
Balance at ending (in shares)	1,959,358
Expected to vest (in shares)	1,959,358

Stock-based Compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 10,003	$ 10,349
Cost of product sales
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	50	129
Research and development
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	1,079	1,241
Selling, general and administrative
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 8,874	$ 8,979

Stock-based Compensation - Black-Scholes pricing model options (Details)	12 Months Ended
	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Annual dividend yield	0.00%
2017 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free interest rate	0.07%
Expected term (in years)	6 months
Expected volatility	65.43%
Annual dividend yield	0.00%
2010 A & R Stock Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free interest rate	1.02%
Expected term (in years)	6 years 29 days
Expected volatility	74.11%
Annual dividend yield	0.00%

Income Taxes - Schedule of income before income tax, domestic and foreign (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Domestic operations	$ (78,801)	$ (93,849)
Foreign operations	(3,495)	(5,936)
Loss before provision for income taxes	$ (82,296)	$ (99,785)

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Section 50
-Paragraph 32
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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-Section 25
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
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Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI http://asc.fasb.org/extlink&oid=123367319&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Topic 944
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-Section S99
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-Subparagraph (SX 210.7-04(8))
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 942
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-Section S99
-Paragraph 1
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Reference 9: http://www.xbrl.org/2003/role/exampleRef
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-Topic 280
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-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Income Taxes - Schedule of effective income tax rate reconciliation (Details)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Income tax expense at statutory rate	21.00%	21.00%
Permanent items	(0.40%)	0.30%
Foreign rate differential	0.10%	0.10%
Impact of foreign operations	0.00%	0.00%
State taxes, net of federal benefit	4.70%	4.70%
Tax rate changes	0.00%	0.10%
Foreign exchange and other	(0.90%)	(0.20%)
Change in valuation allowance	(24.50%)	(26.00%)
Effective income tax rate	0.00%	0.00%

Income Taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred tax assets:
Accrued expenses and other	$ 6,712	$ 5,062
Prepaid licensing arrangement	9,441	10,251
Interest expense	10,708	7,141
Stock compensation	8,583	6,819
Lease liability	1,081	1,551
Research and development credits	2,461	2,485
Net operating losses	87,324	73,278
Total deferred tax assets	126,310	106,587
Deferred tax liabilities:
Fixed assets, including leases	(210)	(220)
Right-to-use asset	(1,024)	(1,479)
Total deferred tax liabilities:	(1,234)	(1,699)
Less: Valuation allowance	(125,076)	(104,888)
Total net deferred tax assets (liabilities)	$ 0	$ 0

Income Taxes - Narrative (Details)	12 Months Ended
Income Taxes - Narrative (Details)	Dec. 31, 2021 USD ($)
Operating Loss Carryforwards [Line Items]
Deferred tax assets tax credit carryforwards research	$ 2,487,000
Deferred tax assets tax credit carryforwards research term	20 years
Valuation allowance increase (decrease)	$ 20,188,000
Unrecognized tax benefits, income tax penalties and interest accrued	0
Foreign Tax Authority
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	63,920,000
Domestic Tax Authority
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	294,101,000
State and Local Jurisdiction
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 231,765,000