Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 01, 2020 | Jun. 28, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
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 | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 174.1 | ||
Entity Common Stock, Shares Outstanding | 45,906,162 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2020 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, 2019. | ||
Entity Central Index Key | 0001494650 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 147,144 | $ 200,990 |
Accounts receivable, net | 13,643 | 2,310 |
Grants and other receivables | 175 | 242 |
Inventory | 3,484 | 7,132 |
Prepaid expenses and other current assets | 3,614 | 2,183 |
Total current assets | 168,060 | 212,857 |
Property and equipment, net | 3,052 | 3,884 |
Other assets | 1,538 | 248 |
Total assets | 172,650 | 216,989 |
Current liabilities: | ||
Accounts payable | 3,625 | 7,116 |
Accrued expenses | 32,514 | 18,421 |
Deferred other income | 0 | 160 |
Total current liabilities | 36,139 | 25,697 |
Long-term debt, net | 74,531 | 72,500 |
Other liabilities | 397 | 181 |
Total liabilities | 111,067 | 98,378 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2019 and 2018; 45,906,162 and 41,227,530 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 46 | 41 |
Additional paid-in capital | 489,565 | 436,554 |
Accumulated deficit | (427,980) | (317,927) |
Accumulated other comprehensive loss | (48) | (57) |
Total stockholders' equity | 61,583 | 118,611 |
Total liabilities and stockholders' equity | $ 172,650 | $ 216,989 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 |
Common Stock, Shares, Issued | 45,906,162 | 41,227,530 |
Common Stock, Shares, Outstanding | 45,906,162 | 41,227,530 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Total revenues | $ 34,631 | $ 7,065 |
Costs and expenses: | ||
Cost of product sales | 5,294 | 1,588 |
Research and development | 20,783 | 10,099 |
Selling, general and administrative | 104,155 | 95,618 |
Total costs and expenses | 130,232 | 107,305 |
Loss from operations | (95,601) | (100,240) |
Other (income) expense: | ||
Grant and other income | 0 | (406) |
Interest income | (2,359) | (2,453) |
Interest expense | 9,623 | 9,229 |
Foreign currency losses | 33 | 48 |
Loss on extinguishment of debt | 7,155 | 0 |
Net loss | $ (110,053) | $ (106,658) |
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (2.63) | $ (2.68) |
Weighted average common shares outstanding, basic and diluted (in shares) | 41,877,527 | 39,765,983 |
Net product revenues | ||
Total revenues | $ 30,401 | $ 7,065 |
Licensing revenues | ||
Total revenues | $ 4,230 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (110,053) | $ (106,658) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustment | 9 | 54 |
Comprehensive loss | $ (110,044) | $ (106,604) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid -in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Shares outstanding (in shares) at Dec. 31, 2017 | 37,802,556 | ||||
Beginning balance at Dec. 31, 2017 | $ 154,496 | $ 38 | $ 365,838 | $ (211,269) | $ (111) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 8,645 | 8,645 | |||
Sale of common stock, net of issuance costs (in shares) | 2,875,000 | ||||
Sale of common stock, net of issuance costs | 59,917 | $ 3 | 59,914 | ||
Exercise of common stock options (in shares) | 482,190 | ||||
Exercise of common stock options | 1,418 | 1,418 | |||
Exercise of warrants (in shares) | 14,647 | ||||
Issuance of common stock under employee stock purchase plan (in shares) | 53,137 | ||||
Issuance of common stock under employee stock purchase plan | 739 | 739 | |||
Foreign currency translation adjustment | 54 | 54 | |||
Net loss | (106,658) | (106,658) | |||
Shares outstanding (in shares) at Dec. 31, 2018 | 41,227,530 | ||||
Ending balance at Dec. 31, 2018 | 118,611 | $ 41 | 436,554 | (317,927) | (57) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 9,999 | 9,999 | |||
Sale of common stock, net of issuance costs (in shares) | 4,250,000 | ||||
Sale of common stock, net of issuance costs | 38,747 | $ 5 | 38,742 | ||
Exercise of common stock options (in shares) | 254,335 | ||||
Exercise of common stock options | 1,038 | 1,038 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 174,297 | ||||
Issuance of common stock under employee stock purchase plan | 1,008 | 1,008 | |||
Issuance of warrants | 2,224 | 2,224 | |||
Foreign currency translation adjustment | 9 | 9 | |||
Net loss | (110,053) | (110,053) | |||
Shares outstanding (in shares) at Dec. 31, 2019 | 45,906,162 | ||||
Ending balance at Dec. 31, 2019 | $ 61,583 | $ 46 | $ 489,565 | $ (427,980) | $ (48) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | ||
Net loss | $ (110,053) | $ (106,658) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,108 | 539 |
Stock-based compensation | 9,860 | 8,543 |
Amortization of debt discount and issuance costs | 658 | 404 |
Loss on extinguishment of debt | 7,155 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (11,333) | (2,310) |
Grants and other receivables | 68 | (196) |
Prepaid expenses and other assets | (26) | (762) |
Inventory | 3,759 | (4,698) |
Accounts payable | (3,856) | 3,171 |
Accrued expenses and other liabilities | 11,845 | 10,150 |
Cash used in operating activities | (90,815) | (91,817) |
Investing activities: | ||
Purchases of property and equipment | (557) | (1,690) |
Cash used in investing activities | (557) | (1,690) |
Financing activities: | ||
Proceeds from the sale of common stock | 41,438 | 63,969 |
Proceeds from long-term debt | 77,596 | 0 |
Proceeds from the issuance of warrants | 2,404 | 0 |
Proceeds from the issuance of common stock under employee stock purchase plan | 1,008 | 739 |
Proceeds from the exercise of stock options | 1,038 | 1,488 |
Cash paid for financing costs | (5,776) | (6,547) |
Payment of withholdings on shares withheld for income taxes | 0 | (70) |
Repayment of Athyrium debt facility | (80,179) | 0 |
Cash provided by financing activities | 37,529 | 59,579 |
Effects of exchange rate changes on cash and cash equivalents | (3) | 64 |
Net decrease in cash, cash equivalents and restricted cash | (53,846) | (33,864) |
Cash, cash equivalents and restricted cash at beginning of period | 201,011 | 234,875 |
Cash, cash equivalents and restricted cash at end of period | 147,165 | 201,011 |
Supplemental disclosure of noncash activities: | ||
Cash paid for interest | 8,785 | 8,253 |
Supplemental disclosure of noncash activities: | ||
Fixed asset purchases within accounts payable and accrued expenses | 38 | 146 |
Fixed asset additions acquired through tenant allowance | 0 | 361 |
Financing costs within accounts payable and accrued expenses | 483 | 0 |
Recognition of initial right-of-use assets | 2,483 | 0 |
Recognition of initial lease liabilities | $ 2,959 | $ 0 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
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, Oslo, Norway and Swindon, England. 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 mcg, is a therapeutic utilizing its proprietary Exhalation Delivery System (EDS) that delivers a topically-acting corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps and, if approved, chronic rhinosinusitis without nasal polyps (also 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, 2019 | |
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, conducting out-licensing activities, pursuing regulatory approvals and most recently, preparing for and launching XHANCE in the US. As of December 31, 2019, the Company had cash and cash equivalents of $147,144. On November 25, 2019, the Company and certain stockholders closed an underwritten public offering (the Offering) of 5,500,000 shares of Company common stock (Common Stock) at a price of $9.75 per share. The Offering consisted of 4,250,000 shares of Common Stock sold by the Company and 1,250,000 shares of Common Stock sold by certain stockholders. As a result of the offering, the Company received $38,747 in net proceeds, after deducting discounts and commissions of $2,383 and offering expenses of approximately $308 payable by the Company. 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 the debt service obligations under the Company's outstanding senior secured notes, including repayment, and to carry out the Company's planned development and commercial activities. If additional capital is not secured when required, the Company may need to delay or curtail its operations until such 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, 2019 | |
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. The Company has exposure to credit risk in accounts receivable from sales of product. XHANCE is sold to wholesale pharmaceutical distributors and PPN partners, who, in turn, sell XHANCE to pharmacies, hospitals and other customers. Five customers represent approximately 62% of the Company's accounts receivable at December 31, 2019 and five customers represent approximately 62% of the Company's net product sales for the year ended December 31, 2019. 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 $145,634 and $199,507 at December 31, 2019 and 2018, respectively. Restricted cash As of December 31, 2019 and 2018, the restricted cash balance included in prepaid expenses and other assets was $21. 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, 2019 and 2018, 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, 2019, the Company believes the carrying value of debt approximates fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. At December 31, 2019 and 2018, 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. Given the nature and historical collectability of the Company’s accounts receivable, an allowance for doubtful accounts was not deemed necessary at December 31, 2019 and 2018. 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, 2019 and 2018. 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. In addition, the Company reimburses (through discounts and allowances) its Customers for sales order management, data and distribution services. ◦ 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. Licensing Revenues During the year ended December 31, 2019, the Company's licensing revenues were generated pursuant to license agreements with Inexia Limited (Inexia) 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 the upfront payments from the licensing agreements of $4,230 as licensing revenue during the year ended December 31, 2019 upon the delivery of the license performance obligations. No licensing revenue was recognized during the year ended December 31, 2018. Advertising expenses The Company expenses the costs of advertising, including promotional expenses, as incurred. Advertising expenses were $18,528 and $9,767 for the years ended December 31, 2019 and 2018, 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 included 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 nonemployees 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, 2019 and 2018, the Company has concluded that a full valuation allowance is 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. Grant income Government grants are agreements that provide cost reimbursement for certain research and development activities over a contractually defined period. Income from government grants is recognized in the period in which related costs are incurred, provided that the conditions under which government grants were provided have been met and only perfunctory obligations are outstanding. Grant income received in excess of costs incurred is recognized as deferred other income. 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, 2019 and 2018, the 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 do not reflect the following potential common shares, as the effect would be antidilutive: Year Ended December 31, 2019 2018 Stock options 7,399,217 6,182,873 Common stock warrants 2,677,188 1,866,831 Employee stock purchase plan — 31,892 Total 10,076,405 8,081,596 Recent accounting pronouncements 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 new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the potential impact of the adoption of this standard on its results of operations, financial position and cash flows and related disclosures. In August 2018, the FASB issued ASU No. 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . ASU 2018-15 requires that certain implementation costs incurred in a cloud computing arrangement be deferred and recognized over the term of the arrangement. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption is permitted. The Company adopted ASU 2018-15 on January 1, 2020 and believes the most significant effect of implementation relates to the recognition of capitalized implementation costs within prepaid expenses and other current assets and the disclosures regarding these capitalized costs. In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . ASU 2018-13 resulted in certain modifications to fair value measurement disclosures, primarily related to level 3 fair value measurements. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption is permitted. The Company does not expect the adoption of this standard to have a material impact on its disclosures. 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 is currently evaluating the potential impact of the adoption of this standard on its results of operations, financial position and cash flows and related disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . The FASB issued the update to require the recognition of lease assets and liabilities on the balance sheet of lessees. The standard will be effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The ASU requires a modified retrospective transition method with the option to elect a package of practical expedients. The Company adopted ASU 2016-02 on 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 our office lease portfolio. Refer to Note 6 for further details. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following: December 31, 2019 2018 Raw materials $ 1,227 $ 1,969 Work-in-process 676 2,344 Finished goods 1,581 2,819 Total inventory $ 3,484 $ 7,132 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment, net, consisted of: December 31, 2019 2018 Computer equipment and software $ 1,112 $ 833 Furniture and fixtures 366 389 Machinery and equipment 3,142 2,723 Leasehold improvements 609 609 Construction in process 70 481 5,299 5,035 Less: accumulated depreciation (2,247) (1,151) $ 3,052 $ 3,884 Depreciation expense was $1,106 and $535 for the years ended December 31, 2019 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
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, which does not require the restatement of prior period amounts, 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). Certain office space leases include options to renew that generally can extend the lease term up to three years. 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 as of December 31, 2019: Balance Sheet Line Item December 31, 2019 Non-current operating lease assets Other assets $ 1,386 Operating lease liabilities: Current operating lease liabilities Accrued expenses and other current liabilities 1,135 Non-current operating lease liabilities Other liabilities 397 Total operating lease liabilities $ 1,532 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, 2019 are: December 31, 2019 Weighted average remaining lease term (years) 1.24 Weighted average discount rate 6.4 % 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, 2019: December 31, 2019 2020 $ 1,193 2021 401 Thereafter — Total undiscounted future minimum lease payments 1,594 Less: difference between undiscounted lease payments and discounted operating lease liabilities (62) Total operating lease liabilities $ 1,532 Operating lease payments include $44 related to options to extend lease terms that are reasonably certain of being exercised. Operating lease costs were $2,154 the year ended December 31, 2019. 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, 2019 | |
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, 2019 2018 Accrued expenses: Product revenue allowances $ 12,858 $ 2,856 Selling, general and administrative expenses 5,544 4,812 Research and development expenses 3,379 933 Payroll expenses 7,810 4,199 Contract sales organization expenses — 4,482 Other 1,788 1,139 Total accrued expenses 31,379 18,421 Other current liabilities: Lease liability $ 1,135 $ — Total other current liabilities 1,135 — Total accrued expenses and other current liabilities $ 32,514 $ 18,421 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Research and Development [Abstract] | |
License Agreements | License Agreements Avanir License Agreement In July 2013, the Company's wholly owned subsidiary, OptiNose AS, entered into the Avanir License Agreement with Avanir Pharmaceuticals, Inc. (Avanir) for the exclusive right to sell AVP-825 (now marketed as Onzetra ® Xsail ® ), a product combining a low-dose powder form of sumatriptan with the Company's Exhalation Delivery System technology platform, for the acute treatment of migraines in adults and any follow-on products under development that consist of a formulation that contains triptans as the sole active ingredient. Through December 31, 2019, under the terms of the Avanir License Agreement, the Company received aggregate cash payments of $70,000 in connection with the initial signing and the achievement of certain development milestones. The Company did not recognize any licensing revenue under the arrangement during the years ended December 31, 2019 and 2018. The Avanir License Agreement was terminated by Avanir on March 10, 2019. As a result, the Company will not receive any future revenues under the agreement. Currax License Agreement On September 25, 2019, OptiNose AS entered into a license agreement (the Currax License Agreement) with Currax Pharmaceuticals LLC (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. In addition, the Company is eligible to receive an additional $750, which is being held in escrow for a limited period to cover certain indemnification obligations. The Company is also eligible to receive a one-time 10% royalty on Onzetra Xsail net sales in excess of $3,000 solely for calendar year 2020, and a $1,000 milestone payment subject to the achievement of a specified regulatory milestone. Inexia License Agreement On January 31, 2019, OptiNose AS entered into a license agreement (the Inexia License Agreement) with Inexia Limited (Inexia) pursuant to which the Company granted Inexia 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 agonism and orexin receptor positive modulation. |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term Debt On December 29, 2017, the Company entered into a Senior Secured Note Purchase Agreement (the Senior Secured Notes) with Athyrium Opportunities III Acquisition LP. The Senior Secured Notes provided the Company with up to $100,000 in capital, of which $75,000 was issued. The Senior Secured Notes bore interest at 9.0% plus the three-month London Inter-bank Offered Rate (LIBOR) rate, subject to a 1.0% floor and were scheduled to mature on June 29, 2023. The Senior Secured Notes bore front-end fees of 1% of the aggregate principal amount, which were paid at issuance. The Company was also required to pay an exit fee of 2% of any principal payments (whether mandatory, voluntary, or at maturity) made throughout the term of the Note Purchase Agreement. On September 12, 2019 (the Closing Date), the Company entered into a Note Purchase Agreement (the Pharmakon Senior Secured Notes) with funds managed by Pharmakon Advisors, LP (Pharmakon), the investment manager of the BioPharma Credit funds (BioPharma). The Pharmakon Senior Secured Notes provide the Company with up to $150,000 in debt financing, of which $80,000 was issued on the Closing Date. The remaining $70,000 of the Pharmakon Senior Secured Notes may be issued as follows: • $30,000 of Pharmakon Senior Secured Notes shall be issued, between September 27, 2019 and February 15, 2020 (the First Delayed Draw Notes), subject to the Company achieving XHANCE net sales and royalties for the quarter ended December 31, 2019 of at least $9,000; • $20,000 of Pharmakon Senior Secured Notes, at the Company’s option, between 15 days after the closing of the First Delayed Draw Notes and August 15, 2020 (the Second Delayed Draw Notes), subject to the Company achieving, either (x) XHANCE net sales and royalties for the fiscal quarter ended March 31, 2020 of at least $11,000 or (y) XHANCE net sales and royalties for the six months ended June 30, 2020 of at least $25,000; and • $20,000 of Pharmakon Senior Secured Notes, at the Company’s option, between 15 days after the closing of the Second Delayed Draw Notes and February 15, 2021 (the Third Delayed Draw Notes, and together with the First Delayed Draw Notes and Second Delayed Draw Notes, collectively, the Delayed Draw Notes), subject to the Company achieving either (x) XHANCE net sales and royalties for the quarter ended September 30, 2020 of at least $14,500 or (y) XHANCE net sales and royalties for the six months ended December 31, 2020 of at least $31,000. The issuance of the Second Delayed Draw Notes and Third Delayed Draw Notes are not conditioned upon the issuance of any prior Delayed Draw Notes. Furthermore, if the Company fails to meet the XHANCE net sales and royalties thresholds required to issue the First Delayed Draw Notes or the Second Delayed Draw Notes, the Company may request BioPharma to issue, in its sole discretion, the entire amount or any lesser amount of such First Delayed Draw Notes and/or Second Delayed Draw Notes upon the closing date of any subsequent Delayed Draw Notes (subject to the Company’s satisfaction of the net sales and royalties thresholds applicable to such subsequent Delayed Draw Notes). The proceeds of the initial Pharmakon Senior Secured Notes issued on the Closing Date were used to repay all existing indebtedness under the note purchase agreement with Athyrium Opportunities III Acquisition LP (Athyrium). The proceeds of the Delayed Draw Notes, if issued, are expected to be used for general corporate purposes. The Pharmakon Senior Secured Notes bear interest at a fixed per annum rate of 10.75% and are scheduled to mature on September 12, 2024 (the Maturity Date). The Company is required to make quarterly interest payments until the Maturity Date. The Company is also required to make principal payments, which are payable in eight equal quarterly installments beginning on December 15, 2022 and continuing until the Maturity Date; provided that the Company may, at its election, postpone any such principal payment until the Maturity Date if, as of the applicable payment date, certain trailing four-quarter consolidated XHANCE net sales and royalties thresholds have been achieved. In conjunction with the Pharmakon Senior Secured Notes, 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 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 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. Additionally, the Company is also required to pay a "make-whole" amount in respect of any principal payments (whether mandatory or voluntary) made prior to the 30-month anniversary of the issuance of the applicable note, 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 payment. The Pharmakon Senior Secured Notes are secured by a pledge of substantially all of the Company's assets and 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, grant certain licenses related to the Company's products, technology and other intellectual property, pay dividends and distributions, repay junior indebtedness and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the Pharmakon Senior Secured Notes contain 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, 2019, 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 notes. On September 12, 2019, in conjunction with the entry into the Pharmakon Senior Secured Notes, the Company terminated the Athyrium senior secured notes and all outstanding amounts under such notes were repaid in full, and all security interests and other liens granted to or held by Athyrium were terminated and released. At the time of termination, the Company paid Athyrium (i) accrued and unpaid interest since June 18, 2019 of $2,049, (ii) an exit fee of 2% of the aggregate principal amount of the notes outstanding under the under the Athyrium note purchase agreement, and (iii) a prepayment fee due under the Athyrium note purchase agreement of $3,669. As a result, the Company recorded a loss on extinguishment of $7,155. The Company recorded interest expense of $9,623 and $9,229 during the years ended December 31, 2019 and 2018, respectively, in conjunction with both the Athyrium senior secured notes and the Pharmakon Senior Secured Notes. Interest expense included total coupon interest, and the amortization of exit fees, front end fees and the amortization of debt issuance costs. The long-term debt balance is comprised of the following: December 31, 2019 2018 Face amount $ 80,000 $ 75,000 Front end fees (1,030) (872) Debt issuance costs (4,439) (1,902) Back end fees — 274 $ 74,531 $ 72,500 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2019 | |
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. In October 2017, the Company adopted a 401(k) matching program for its US employees. 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 $1,238 and $645 related to the Company match applicable to employee contributions for the years ended December 31, 2019 and 2018, 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, 2019, approximately $178 is recorded in accrued expenses related to the Company match. For Norway and UK employees, the Company maintains defined contribution pension plans which meet statutory requirements of those jurisdictions. The Company incurred costs of $19 and $81 related to the pension plans for the years ended December 31, 2019 and 2018, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Purchase commitments As of December 31, 2019, 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 |
Stockholders' equity
Stockholders' equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' equity | Stockholders' equity Common stock On June 11, 2018, the Company and certain stockholders closed an underwritten public offering of 5,750,000 shares of Common Stock at a price of $22.25 per share. The offering consisted of 2,875,000 shares of Common Stock sold by the Company and 2,875,000 shares of Common Stock sold by certain stockholders. As a result of the offering, the Company received $59,917 in net proceeds, after deducting discounts and commissions of $3,678 and offering expenses of approximately $373 payable by the Company. On November 25, 2019, the Company and certain stockholders closed the Offering of 5,500,000 shares of Company Common Stock at a price of $9.75 per share. The Offering consisted of 4,250,000 shares of Common Stock sold by the Company and 1,250,000 shares of Common Stock sold by certain stockholders. As a result of the offering, the Company received $38,747 in net proceeds, after deducting discounts and commissions of $2,383 and offering expenses of approximately $308 payable by the Company. 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, 2019. Common stock warrants On September 12, 2019, in conjunction with the issuance of the Pharmakon Senior Secured Notes, the Company issued warrants to purchase an aggregate of 810,357 shares of Common Stock at an exercise price of $6.72. Refer to Note 9 for further details. 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 1.67 % Expected term (in years) 3 Expected volatility 65.10 % Annual dividend yield 0.00 % Fair value of common stock $ 6.72 As of December 31, 2019, the Company had the following warrants outstanding to purchase shares of Common Stock: Number of Shares Exercise Price Per Share Expiration Date 1,866,831 $8.16 November 1, 2020 810,357 $6.72 September 12, 2022 |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019, 10,055,648 shares of the Company's common stock were authorized to be issued under the A&R Plan, and 1,813,717 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, commencing on January 1, 2018 and continuing 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 The following table summarizes the activity related to stock option grants to employees and nonemployees for the years ended December 31, 2019: Shares Weighted Weighted Outstanding at December 31, 2018 6,182,873 $ 10.60 6.67 Granted 2,088,673 7.72 Exercised (254,335) 4.09 Expired — — Forfeited (617,994) 12.96 Outstanding at December 31, 2019 7,399,217 $ 9.81 6.37 Exercisable at December 31, 2019 4,287,676 $ 9.43 4.68 Vested and expected to vest at December 31, 2019 7,399,217 $ 9.81 6.37 During the year ended December 31, 2019, stock options to purchase 2,088,673 shares of common stock were granted to employees that generally vest over four The total aggregate intrinsic value of stock options exercised during the years ended December 31, 2019 and 2018 was $1,005 and $9,255, respectively. The aggregate intrinsic value of stock options outstanding and stock options exercisable as of December 31, 2019 was $18,397 and $14,431, respectively. At December 31, 2019, the unrecognized compensation cost related to unvested stock options expected to vest was $18,733. This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.4 years. Restricted stock units The Company has issued RSUs for which vesting generally occurs over a period not greater than four years. In April 2019, the Company issued 20,600 RSUs at a price of $10.20, all of which forfeited during the year ended December 31, 2019. No RSUs were issued or outstanding at December 31, 2018. 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, 2019, 934,695 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. 707,261 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, commencing on January 1, 2018 and continuing 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 $405 and $446 during the years ended December 31, 2019 and 2018, 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, 2019 and 2018: Year Ended December 31, 2019 2018 Cost of product sales $ 103 $ 9 Research and development 1,062 989 Selling, general and administrative 8,695 7,545 Total stock-based compensation expense $ 9,860 $ 8,543 In addition, stock-based compensation expense of $150 and $27 was charged to inventory and prepaid expenses and other assets, respectively, during the year ended December 31, 2019, which represents 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 shares 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, 2019 2010 A&R Stock Incentive Plan 2017 Employee Stock Purchase Plan Risk free interest rate 2.47 % 2.32 % Expected term (in years) 6.05 0.50 Expected volatility 67.03 % 73.34 % 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 nonemployee 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, 2019 | |
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, 2019 2018 Domestic operations $ (103,109) $ (146,247) Foreign operations (6,944) 39,589 Loss before provision for income taxes $ (110,053) $ (106,658) 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, 2019 2018 Income tax expense at statutory rate 21.0 % 21.0 % Permanent items (0.8) 0.5 Foreign rate differential — (0.8) Impact of foreign operations — (7.2) State taxes, net of federal benefit 3.0 3.9 Tax rate changes — (0.6) Foreign exchange and other 0.7 (0.6) Change in valuation allowance (23.9) (16.2) 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, 2019 2018 Deferred tax assets: Accrued expenses and other $ 4,349 $ 1,674 Prepaid licensing arrangement 11,154 11,562 Interest expense 4,469 1,267 Stock compensation 5,468 3,493 Research and development credits 2,485 2,485 Net operating losses 51,644 32,548 Total deferred tax assets 79,569 53,029 Deferred tax liabilities: Fixed assets, including leases (630) (409) Total deferred tax liabilities: (630) (409) Less: Valuation allowance (78,939) (52,620) Total net deferred tax assets (liabilities) $ — $ — During 2018, our wholly-owned subsidiary in Norway licensed certain intellectual property rights related to XHANCE to our US subsidiary. While this transaction did not result in any gain or loss in the condensed consolidated statements of operations, the transaction generated taxable income in both Norway and the US. Norway tax loss carryforwards were utilized to offset the taxable income in Norway and the income reduced the current year US taxable loss. There were no cash taxes associated with the transaction. As of December 31, 2019, the Company had foreign net operating loss (NOL) carry forwards of $52,806 primarily from its operations in Norway. As of December 31, 2019, the Company had federal and state NOLs of $164,937 and $90,594, 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 2028. 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, 2019 and 2018, 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 $26,319 during the year ended December 31, 2019. 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 carryforwards are used in future periods. |
Related-party transactions
Related-party transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related-party transactions | Related-party transactionsDuring the year ended December 31, 2019 and 2018, the Company reimbursed Avista Capital Holdings, LP and related parties $32 and $51, respectively in expenses, primarily related to legal fees incurred in conjunction with the Company's Offerings of Common Stock in November 2019 and June 2018. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent eventsOn February 13, 2020, the First Delayed Draw Notes were issued as the Company achieved the XHANCE net sales and royalties threshold for the quarter ended December 31, 2019. The Company received $30,000 from the issuance of the First Delayed Draw Notes and incurred additional debt issuance costs of $150, which will be amortized to interest expense over the term of the Pharmakon Senior Secured Notes. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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. |
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. |
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. Given the nature and historical collectability of the Company’s accounts receivable, an allowance for doubtful accounts was not deemed necessary at December 31, 2019 and 2018. |
Inventory | InventoryInventories 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, licensing revenues, and grant income | 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. In addition, the Company reimburses (through discounts and allowances) its Customers for sales order management, data and distribution services. ◦ 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. Licensing Revenues During the year ended December 31, 2019, the Company's licensing revenues were generated pursuant to license agreements with Inexia Limited (Inexia) 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 the upfront payments from the licensing agreements of $4,230 as licensing revenue during the year ended December 31, 2019 upon the delivery of the license performance obligations. No licensing revenue was recognized during the year ended December 31, 2018. Grant income Government grants are agreements that provide cost reimbursement for certain research and development activities over a contractually defined period. Income from government grants is recognized in the period in which related costs are incurred, provided that the conditions under which government grants were provided have been met and only perfunctory obligations are outstanding. Grant income received in excess of costs incurred is recognized as deferred other income. |
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 included 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 nonemployees 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. |
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 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 new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the potential impact of the adoption of this standard on its results of operations, financial position and cash flows and related disclosures. In August 2018, the FASB issued ASU No. 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . ASU 2018-15 requires that certain implementation costs incurred in a cloud computing arrangement be deferred and recognized over the term of the arrangement. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption is permitted. The Company adopted ASU 2018-15 on January 1, 2020 and believes the most significant effect of implementation relates to the recognition of capitalized implementation costs within prepaid expenses and other current assets and the disclosures regarding these capitalized costs. In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . ASU 2018-13 resulted in certain modifications to fair value measurement disclosures, primarily related to level 3 fair value measurements. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption is permitted. The Company does not expect the adoption of this standard to have a material impact on its disclosures. 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 is currently evaluating the potential impact of the adoption of this standard on its results of operations, financial position and cash flows and related disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . The FASB issued the update to require the recognition of lease assets and liabilities on the balance sheet of lessees. The standard will be effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The ASU requires a modified retrospective transition method with the option to elect a package of practical expedients. The Company adopted ASU 2016-02 on 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 our office lease portfolio. Refer to Note 6 for further details. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Property and equipment | The estimated useful lives of property and equipment are as follows: Computer equipment 2-3 years Software 3 years Machinery & production equipment 5-10 years Furniture & fixtures 3-5 years Leasehold improvements Shorter of lease term or useful life Property and equipment, net, consisted of: December 31, 2019 2018 Computer equipment and software $ 1,112 $ 833 Furniture and fixtures 366 389 Machinery and equipment 3,142 2,723 Leasehold improvements 609 609 Construction in process 70 481 5,299 5,035 Less: accumulated depreciation (2,247) (1,151) $ 3,052 $ 3,884 |
Schedule of antidilutive shares excluded from earnings per share | Diluted net loss per common share for the periods presented do not reflect the following potential common shares, as the effect would be antidilutive: Year Ended December 31, 2019 2018 Stock options 7,399,217 6,182,873 Common stock warrants 2,677,188 1,866,831 Employee stock purchase plan — 31,892 Total 10,076,405 8,081,596 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: December 31, 2019 2018 Raw materials $ 1,227 $ 1,969 Work-in-process 676 2,344 Finished goods 1,581 2,819 Total inventory $ 3,484 $ 7,132 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | The estimated useful lives of property and equipment are as follows: Computer equipment 2-3 years Software 3 years Machinery & production equipment 5-10 years Furniture & fixtures 3-5 years Leasehold improvements Shorter of lease term or useful life Property and equipment, net, consisted of: December 31, 2019 2018 Computer equipment and software $ 1,112 $ 833 Furniture and fixtures 366 389 Machinery and equipment 3,142 2,723 Leasehold improvements 609 609 Construction in process 70 481 5,299 5,035 Less: accumulated depreciation (2,247) (1,151) $ 3,052 $ 3,884 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Assets and Liabilities | The table below presents the operating lease assets and liabilities recognized on the Company's consolidated balance sheets as of December 31, 2019: Balance Sheet Line Item December 31, 2019 Non-current operating lease assets Other assets $ 1,386 Operating lease liabilities: Current operating lease liabilities Accrued expenses and other current liabilities 1,135 Non-current operating lease liabilities Other liabilities 397 Total operating lease liabilities $ 1,532 The Company's weighted average remaining lease term and weighted average discount rate for operating leases as of December 31, 2019 are: December 31, 2019 Weighted average remaining lease term (years) 1.24 Weighted average discount rate 6.4 % |
Operating Lease, Liability, Maturity | 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, 2019: December 31, 2019 2020 $ 1,193 2021 401 Thereafter — Total undiscounted future minimum lease payments 1,594 Less: difference between undiscounted lease payments and discounted operating lease liabilities (62) Total operating lease liabilities $ 1,532 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses and other current liabilities consisted of: December 31, 2019 2018 Accrued expenses: Product revenue allowances $ 12,858 $ 2,856 Selling, general and administrative expenses 5,544 4,812 Research and development expenses 3,379 933 Payroll expenses 7,810 4,199 Contract sales organization expenses — 4,482 Other 1,788 1,139 Total accrued expenses 31,379 18,421 Other current liabilities: Lease liability $ 1,135 $ — Total other current liabilities 1,135 — Total accrued expenses and other current liabilities $ 32,514 $ 18,421 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The long-term debt balance is comprised of the following: December 31, 2019 2018 Face amount $ 80,000 $ 75,000 Front end fees (1,030) (872) Debt issuance costs (4,439) (1,902) Back end fees — 274 $ 74,531 $ 72,500 |
Stockholders' equity (Tables)
Stockholders' equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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 1.67 % Expected term (in years) 3 Expected volatility 65.10 % Annual dividend yield 0.00 % Fair value of common stock $ 6.72 |
Schedule of Warrants | As of December 31, 2019, the Company had the following warrants outstanding to purchase shares of Common Stock: Number of Shares Exercise Price Per Share Expiration Date 1,866,831 $8.16 November 1, 2020 810,357 $6.72 September 12, 2022 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of stock option activity | The following table summarizes the activity related to stock option grants to employees and nonemployees for the years ended December 31, 2019: Shares Weighted Weighted Outstanding at December 31, 2018 6,182,873 $ 10.60 6.67 Granted 2,088,673 7.72 Exercised (254,335) 4.09 Expired — — Forfeited (617,994) 12.96 Outstanding at December 31, 2019 7,399,217 $ 9.81 6.37 Exercisable at December 31, 2019 4,287,676 $ 9.43 4.68 Vested and expected to vest at December 31, 2019 7,399,217 $ 9.81 6.37 |
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, 2019 and 2018: Year Ended December 31, 2019 2018 Cost of product sales $ 103 $ 9 Research and development 1,062 989 Selling, general and administrative 8,695 7,545 Total stock-based compensation expense $ 9,860 $ 8,543 |
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, 2019 2010 A&R Stock Incentive Plan 2017 Employee Stock Purchase Plan Risk free interest rate 2.47 % 2.32 % Expected term (in years) 6.05 0.50 Expected volatility 67.03 % 73.34 % Annual dividend yield 0.00 % 0.00 % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign | Income taxes are based on the following book income (loss) before income tax expense: Year Ended December 31, 2019 2018 Domestic operations $ (103,109) $ (146,247) Foreign operations (6,944) 39,589 Loss before provision for income taxes $ (110,053) $ (106,658) |
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, 2019 2018 Income tax expense at statutory rate 21.0 % 21.0 % Permanent items (0.8) 0.5 Foreign rate differential — (0.8) Impact of foreign operations — (7.2) State taxes, net of federal benefit 3.0 3.9 Tax rate changes — (0.6) Foreign exchange and other 0.7 (0.6) Change in valuation allowance (23.9) (16.2) 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, 2019 2018 Deferred tax assets: Accrued expenses and other $ 4,349 $ 1,674 Prepaid licensing arrangement 11,154 11,562 Interest expense 4,469 1,267 Stock compensation 5,468 3,493 Research and development credits 2,485 2,485 Net operating losses 51,644 32,548 Total deferred tax assets 79,569 53,029 Deferred tax liabilities: Fixed assets, including leases (630) (409) Total deferred tax liabilities: (630) (409) Less: Valuation allowance (78,939) (52,620) Total net deferred tax assets (liabilities) $ — $ — |
Liquidity (Details)
Liquidity (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 25, 2019 | Jun. 11, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Subsidiary, Sale of Stock [Line Items] | ||||
Cash and cash equivalents | $ 147,144 | $ 200,990 | ||
Public Offering | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued (in shares) | 5,500,000 | 5,750,000 | ||
Price per share (usd per share) | $ 9.75 | $ 22.25 | ||
Consideration received on transaction | $ 38,747 | $ 59,917 | ||
Fees and commissions | 2,383 | |||
Deferred offering costs | $ 308 | $ 373 | ||
The Company | Public Offering | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued (in shares) | 4,250,000 | 2,875,000 | ||
Certain Stockholders | Public Offering | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued (in shares) | 1,250,000 | 2,875,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Concentration risk (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Accounts Receivable | |
Concentration Risk [Line Items] | |
Concentration risk | 62.00% |
Sales Revenue, Net | |
Concentration Risk [Line Items] | |
Concentration risk | 62.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Cash, uninsured amount | $ 145,634,000 | $ 199,507,000 |
Loss on sale of equipment | 0 | 0 |
Revenues | 34,631,000 | 7,065,000 |
Advertising expense | 18,528,000 | 9,767,000 |
Prepaid Expenses and Other Current Assets | ||
Disaggregation of Revenue [Line Items] | ||
Restricted cash | 21,000 | 21,000 |
License | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 4,230,000 | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
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_7
Summary of Significant Accounting Policies - Antidilutive shares excluded from earnings per share (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share (in shares) | 10,076,405 | 8,081,596 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share (in shares) | 7,399,217 | 6,182,873 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share (in shares) | 2,677,188 | 1,866,831 |
Employee stock purchase plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share (in shares) | 0 | 31,892 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,227 | $ 1,969 |
Work-in-process | 676 | 2,344 |
Finished goods | 1,581 | 2,819 |
Total inventory | $ 3,484 | $ 7,132 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,299 | $ 5,035 |
Less: accumulated depreciation | (2,247) | (1,151) |
Property and equipment, net | 3,052 | 3,884 |
Depreciation | 1,106 | 535 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,112 | 833 |
Furniture & fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 366 | 389 |
Machinery & production equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,142 | 2,723 |
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 | 70 | $ 481 |
Inventories | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation | 315 | |
Prepaid Expenses and Other Current Assets | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation | $ 49 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Jan. 01, 2019 | |
Leases [Abstract] | ||
Operating lease assets | $ 2,411 | |
Total operating lease liabilities | $ 1,532 | $ 2,887 |
Renewal term | 3 years | |
Option to renew, extension of lease term | $ 44 | |
Operating lease costs | 2,154 | |
Cash paid for amounts included in the measurement of operating lease liabilities | $ 1,589 |
Leases - Operating lease assets
Leases - Operating lease assets and liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
Non-current operating lease assets | $ 1,386 | |
Operating lease liabilities: | ||
Current operating lease liabilities | 1,135 | |
Non-current operating lease liabilities | 397 | |
Total operating lease liabilities | $ 1,532 | $ 2,887 |
Leases - Weighted average remai
Leases - Weighted average remaining lease term and weighted average discount rate (Details) | Dec. 31, 2019 |
Leases [Abstract] | |
Weighted average remaining lease term (years) | 1 year 2 months 26 days |
Weighted average discount rate | 6.40% |
Leases - Operating lease maturi
Leases - Operating lease maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
Operating leases | ||
2020 | $ 1,193 | |
2021 | 401 | |
Thereafter | 0 | |
Total undiscounted future minimum lease payments | 1,594 | |
Less: difference between undiscounted lease payments and discounted operating lease liabilities | (62) | |
Total operating lease liabilities | $ 1,532 | $ 2,887 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Product revenue allowances | $ 12,858 | $ 2,856 |
Selling, general and administrative expenses | 5,544 | 4,812 |
Research and development expenses | 3,379 | 933 |
Payroll expenses | 7,810 | 4,199 |
Contract sales organization expenses | 0 | 4,482 |
Other | 1,788 | 1,139 |
Total accrued expenses | 31,379 | 18,421 |
Lease liability | 1,135 | |
Total other current liabilities | 1,135 | |
Total accrued expenses and other current liabilities | $ 32,514 | $ 18,421 |
License Agreements (Details)
License Agreements (Details) | 12 Months Ended | |
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Aggregate cash payments received from license agreement | $ 70,000,000 | |
AVP-825 License Agreement | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Licensing revenue | 0 | $ 0 |
Currax License Agreement | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Upfront payment received | 3,730,000 | |
Additional revenue eligible and held in escrow | $ 750,000 | |
Royalty Agreement Terms | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Percentage of royalty | 0.10 | |
Development milestone payments eligible to be received (up to) | $ 3,000,000 | |
Sales milestone payments eligible to be received (up to) | 1,000,000 | |
Inexia License Agreement | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Upfront payment received | 500,000 | |
Development milestone payments eligible to be received (up to) | 8,000,000 | |
Sales milestone payments eligible to be received (up to) | $ 37,000,000 |
Long-term Debt - Narrative (Det
Long-term Debt - Narrative (Details) | Sep. 12, 2019USD ($)installment$ / sharesshares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2020USD ($) | Feb. 13, 2020USD ($) | Dec. 29, 2017USD ($) |
Debt Instrument [Line Items] | ||||||
Gain (Loss) on Extinguishment of Debt | $ (7,155,000) | $ 0 | ||||
Senior Notes | Note Purchase Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Unused borrowing capacity | $ 100,000,000 | |||||
Face amount | $ 80,000,000 | $ 75,000,000 | ||||
Stated interest rate | 10.75% | 9.00% | ||||
Upfront fee | 1.00% | |||||
Exit fee | 2.00% | |||||
Debt maximum borrowing capacity | $ 150,000,000 | |||||
Debt principal payments, number of installments | installment | 8 | |||||
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 | |||||
Loans, term | 5 years | |||||
Debt issuance costs | $ 4,848,000 | |||||
Fair Value Adjustment of Warrants | $ 2,404,000 | |||||
Debt issuance costs, additional as percentage of principal amount | 0.005 | |||||
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 | $ 9,623,000 | $ 9,229,000 | ||||
Senior Notes | Note Purchase Agreement | London Interbank Offered Rate (LIBOR) | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate floor | 1.00% | |||||
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 - Second Delayed Draw Notes | ||||||
Debt Instrument [Line Items] | ||||||
Face amount | 20,000,000 | |||||
Senior Notes | Note Purchase Agreement - Second Delayed Draw Notes | Quarter Ended March 31, 2020 | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance criteria term, net sales and royalties benchmark | 11,000,000 | |||||
Senior Notes | Note Purchase Agreement - Second Delayed Draw Notes | Six Months Ended June 30, 2020 | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance criteria term, net sales and royalties benchmark | 25,000,000 | |||||
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 - Third Delayed Draw Notes | Six Months Ended December 31, 2020 | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance criteria term, net sales and royalties benchmark | 31,000,000 | |||||
Senior Notes | Athyrium Senior Secured Notes | ||||||
Debt Instrument [Line Items] | ||||||
Prepayment premium amount | 3,669,000 | |||||
Accrued and unpaid interest | $ 2,049,000 | |||||
Exit fee (as a percent) | 0.02 | |||||
Gain (Loss) on Extinguishment of Debt | $ (7,155,000) | |||||
Senior Notes | Scenario, Forecast | Note Purchase Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Face amount | $ 70,000 | |||||
Senior Notes | Subsequent Event | Note Purchase Agreement - First Delayed Draw Notes | ||||||
Debt Instrument [Line Items] | ||||||
Face amount | $ 30,000,000 | |||||
Debt issuance costs | $ 150,000 |
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, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Face amount | $ 80,000 | $ 75,000 |
Front end fees | (1,030) | (872) |
Debt issuance costs | (4,439) | (1,902) |
Back end fees | 0 | 274 |
Long-term Debt | $ 74,531 | $ 72,500 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Maximum annual contributions per employee | 100.00% | |
Defined contribution plan, cost | $ 1,238 | $ 645 |
Accrued expenses related to the Company match | 178 | |
Foreign Plan | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Defined contribution plan, cost | $ 19 | $ 81 |
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) $ in Thousands | Dec. 31, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Purchase obligation | $ 0 |
Stockholders' equity - Narrativ
Stockholders' equity - Narrative (Details) $ / shares in Units, $ in Thousands | Nov. 25, 2019USD ($)$ / sharesshares | Jun. 11, 2018USD ($)$ / sharesshares | Dec. 31, 2019vote$ / shares | Sep. 12, 2019$ / sharesshares |
Class of Stock [Line Items] | ||||
Vote per share | vote | 1 | |||
Dividends declared (usd per share) | $ / shares | $ 0 | |||
Note Purchase Agreement | Senior Notes | ||||
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 | |||
Public Offering | ||||
Class of Stock [Line Items] | ||||
Number of shares issued (in shares) | shares | 5,500,000 | 5,750,000 | ||
Price per share (usd per share) | $ / shares | $ 9.75 | $ 22.25 | ||
Consideration received on transaction | $ | $ 38,747 | $ 59,917 | ||
Sale of stock discounts | $ | 3,678 | |||
Deferred offering costs | $ | 308 | $ 373 | ||
Fees and commissions | $ | $ 2,383 | |||
The Company | Public Offering | ||||
Class of Stock [Line Items] | ||||
Number of shares issued (in shares) | shares | 4,250,000 | 2,875,000 | ||
Certain Stockholders | Public Offering | ||||
Class of Stock [Line Items] | ||||
Number of shares issued (in shares) | shares | 1,250,000 | 2,875,000 |
Stockholders' equity - Grant da
Stockholders' equity - Grant date fair value of warrants, valuation assumptions (Details) | Sep. 12, 2019$ / shares |
Measurement Input, Risk Free Interest Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 0.0167 |
Measurement Input, Expected Term | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 3 |
Measurement Input, Price Volatility | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 0.6510 |
Measurement Input, Expected Dividend Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 0 |
Measurement Input, Share Price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 6.72 |
Stockholders' equity - Warrants
Stockholders' equity - Warrants (Details) | Dec. 31, 2019$ / sharesshares |
Warrants Expiring November 1, 2020 | |
Class of Stock [Line Items] | |
Number of warrants outstanding (in shares) | shares | 1,866,831 |
Common stock warrant exercise price (in dollars per share) | $ / shares | $ 8.16 |
Warrants Expiring September 12, 2022 | |
Class of Stock [Line Items] | |
Number of warrants outstanding (in shares) | shares | 810,357 |
Common stock warrant exercise price (in dollars per share) | $ / shares | $ 6.72 |
Stock-based Compensation - Narr
Stock-based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum annual contributions per employee | 100.00% | ||
Stock-based compensation expense | $ 9,860 | $ 8,543 | |
Expected dividend yield | 0.00% | ||
Inventories | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 150 | ||
Prepaid Expenses and Other Current Assets | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 27 | ||
Service Based Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 4 years | ||
Granted (in shares) | 2,088,673 | ||
Fair value of common stock (in dollars per share) | $ 4.79 | ||
Intrinsic value of exercised options | $ 1,005 | $ 9,255 | |
Intrinsic value of options outstanding | 18,397 | ||
Intrinsic value of exercisable options | 14,431 | ||
Unrecognized compensation cost | $ 18,733 | ||
Unrecognized compensation, estimated weighted-average amortization period | 2 years 4 months 24 days | ||
Restricted Stock Units (RSUs) | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 4 years | ||
Shares issued (in shares) | 20,600 | 0 | |
Price issued (in dollars per share) | $ 10.20 | ||
Shares outstanding (in shares) | 0 | ||
Amended and Restated Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares authorized under plan (shares) | 10,055,648 | ||
Number of shares reserved for future issuance under plan (shares) | 1,813,717 | ||
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) | 934,695 | ||
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 | $ 25 | ||
Stock-based compensation expense | $ 405 | $ 446 | |
Expected dividend yield | 0.00% |
Stock-based Compensation - Serv
Stock-based Compensation - Service-based stock options (Details) - Service Based Stock Options - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Service-based stock options activity | ||
Shares outstanding, beginning (in shares) | 6,182,873 | |
Granted (in shares) | 2,088,673 | |
Exercised (in shares) | (254,335) | |
Expired (in shares) | 0 | |
Forfeited (in shares) | (617,994) | |
Shares outstanding, ending (in shares) | 7,399,217 | 6,182,873 |
Exercisable at end of period (in shares) | 4,287,676 | |
Vested and expected to vest at end of period(in shares) | 7,399,217 | |
Service-based stock options weighted average exercise price | ||
Beginning balance, Weighted average exercise price (in dollars per share) | $ 10.60 | |
Granted, Weighted average exercise price (in dollars per share) | 7.72 | |
Exercised, Weighted average exercise price (in dollars per share) | 4.09 | |
Expired, Weighted average exercise price (in dollars per share) | 0 | |
Forfeited, Weighted average exercise price (in dollars per share) | 12.96 | |
Ending balance, Weighted average exercise price (in dollars per share) | 9.81 | $ 10.60 |
Options exercisable, Weighted average exercise price per share (in dollars per share) | 9.43 | |
Vested and expected to vest, Weighted average exercise price per share (in dollars per share) | $ 9.81 | |
Service-based stock options, additional disclosures | ||
Options outstanding, Weighted average remaining contractual life | 6 years 4 months 13 days | 6 years 8 months 1 day |
Options exercisable, Weighted average remaining contractual life | 4 years 8 months 4 days | |
Vested and expected to vest, Weighted average remaining contractual life | 6 years 4 months 13 days |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 9,860 | $ 8,543 |
Cost of product sales | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 103 | 9 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 1,062 | 989 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 8,695 | $ 7,545 |
Stock-based Compensation - Blac
Stock-based Compensation - Black-Scholes pricing model options (Details) | 12 Months Ended |
Dec. 31, 2019 | |
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 | 2.32% |
Expected term (in years) | 6 months |
Expected volatility | 73.34% |
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 | 2.47% |
Expected term (in years) | 6 years 18 days |
Expected volatility | 67.03% |
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, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Domestic operations | $ (103,109) | $ (146,247) |
Foreign operations | (6,944) | 39,589 |
Loss before provision for income taxes | $ (110,053) | $ (106,658) |
Income Taxes - Schedule of effe
Income Taxes - Schedule of effective income tax rate reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense at statutory rate | 21.00% | 21.00% |
Permanent items | (0.80%) | 0.50% |
Foreign rate differential | 0.00% | (0.80%) |
Impact of foreign operations | 0.00% | (7.20%) |
State taxes, net of federal benefit | 3.00% | 3.90% |
Tax rate changes | 0.00% | (0.60%) |
Foreign exchange and other | 0.70% | (0.60%) |
Change in valuation allowance | (23.90%) | (16.20%) |
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, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Accrued expenses and other | $ 4,349 | $ 1,674 |
Prepaid licensing arrangement | 11,154 | 11,562 |
Interest expense | 4,469 | 1,267 |
Stock compensation | 5,468 | 3,493 |
Research and development credits | 2,485 | 2,485 |
Net operating losses | 51,644 | 32,548 |
Total deferred tax assets | 79,569 | 53,029 |
Deferred tax liabilities: | ||
Fixed assets, including leases | (630) | (409) |
Total deferred tax liabilities: | (630) | (409) |
Less: Valuation allowance | (78,939) | (52,620) |
Total net deferred tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Valuation allowance increase (decrease) | $ 26,319,000 |
Unrecognized tax benefits, income tax penalties and interest accrued | 0 |
Foreign Tax Authority | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | 52,806,000 |
Domestic Tax Authority | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | 164,937,000 |
State and Local Jurisdiction | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | $ 90,594,000 |
Related-party transactions (Det
Related-party transactions (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Investor | Fees For IPO And Series D Convertible Stock | ||
Related Party Transaction [Line Items] | ||
Amount of transaction | $ 32 | $ 51 |
Subsequent events (Details)
Subsequent events (Details) - Subsequent Event - Senior Notes - Note Purchase Agreement - First Delayed Draw Notes $ in Thousands | Feb. 13, 2020USD ($) |
Subsequent Event [Line Items] | |
Face amount | $ 30,000 |
Debt issuance costs | $ 150 |