Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 01, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38241 | ||
Entity Registrant Name | OPTINOSE, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 42-1771610 | ||
Entity Address, Address Line One | 1020 Stony Hill Road | ||
Entity Address, Address Line Two | Suite 300 | ||
Entity Address, City or Town | Yardley | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19067 | ||
City Area Code | 267 | ||
Local Phone Number | 364-3500 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | OPTN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 94.6 | ||
Entity Common Stock, Shares Outstanding (in shares) | 82,418,106 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2022 annual meeting of stockholders are incorporated by reference into Part III of this Form 10-K where indicated. Such definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the year ended December 31, 2021. | ||
Entity central index key | 0001494650 | ||
Document fiscal year focus | 2021 | ||
Document fiscal period focus | FY | ||
Amendment flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Philadelphia, PA |
Auditor Firm ID | 42 |
Consolidated Balance Sheets
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 (Pa
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 Oper
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 Comp
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) |
Consolidated Statements of Chan
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
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
Organization and Description of Business | 12 Months Ended |
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
Liquidity | 12 Months Ended |
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 Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Significant Accounting Policies | 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
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | 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
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment 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 Depreciation expense was $645 and $1,454 for the years ended December 31, 2021 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 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. |
Accrued Expenses and Other Curr
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 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
License Agreements | 12 Months Ended |
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. |
Long-term Debt
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 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 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
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. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
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
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 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 |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | 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 1 st 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 31 st 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 Weighted 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 , whic h 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 1 st 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 31 st 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
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of presentation | 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 | 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 | 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 | 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. |
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 | 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 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 | 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 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 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 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 |
Advertising expenses | Advertising expensesThe Company expenses the costs of advertising, including promotional expenses, as incurred. |
Research and development | 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 | 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 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 | 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. |
Summary of Significant Accoun_3
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)
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)
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)
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 | 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 |
Accrued Expenses and Other Cu_2
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)
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 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Grant Date Fair Value of Warrant, Valuation Assumptions | 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 |
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 (Table
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 Weighted 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)
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)
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 Accoun_4
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 Accoun_5
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 Accoun_6
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 Accoun_7
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 Accoun_8
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 Accoun_9
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 |
Summary of Significant Accou_10
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 Accou_11
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)
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
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
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)
Leases - Narrative (Details) - USD ($) | 12 Months Ended | ||
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
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 remai
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 maturi
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 Cu_3
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)
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 (Det
Long-term Debt - Narrative (Details) | Aug. 13, 2020USD ($)shares | Sep. 12, 2019USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Nov. 18, 2021USD ($)$ / sharesshares | Mar. 02, 2021USD ($) | Dec. 01, 2020USD ($) | Feb. 13, 2020USD ($) |
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 lo
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 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Thousands | 12 Months Ended | |
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 (
Commitments and Contingencies (Details) | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Purchase obligation | $ 0 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) | Nov. 18, 2021USD ($)$ / sharesshares | Aug. 18, 2020USD ($)$ / sharesshares | Aug. 13, 2020USD ($)shares | Dec. 31, 2021vote$ / 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 da
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 | |
Fair value of common stock | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 1.60 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants Outstanding (Details) - Warrants Expiring November 15, 2024 | Dec. 31, 2021$ / sharesshares |
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 - Narr
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 - Serv
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 - Sche
Stock-based Compensation - Schedule of RSUs (Details) - Restricted stock units | 12 Months Ended |
Dec. 31, 2021shares | |
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 - Stoc
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 - Blac
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 inco
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) |
Income Taxes - Schedule of effe
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 defe
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 (Detai
Income Taxes - Narrative (Details) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
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 |