Document and Entity Information
Document and Entity Information Document - shares | 3 Months Ended | |
Mar. 31, 2019 | May 06, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | OptiNose, Inc. | |
Entity Central Index Key | 0001494650 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 41,264,422 | |
Entity Emerging Growth Company | true | |
Entity Small Business | true | |
Entity Ex Transition Period | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 171,316 | $ 200,990 |
Accounts receivable, net | 5,793 | 2,310 |
Grants and other receivables | 124 | 242 |
Inventory | 5,716 | 7,132 |
Prepaid expenses and other current assets | 3,833 | 2,183 |
Total current assets | 186,782 | 212,857 |
Property and equipment, net | 3,715 | 3,884 |
Other assets | 2,495 | 248 |
Total assets | 192,992 | 216,989 |
Current liabilities: | ||
Accounts payable | 7,676 | 7,116 |
Accrued expenses and other current liabilities | 19,192 | 18,421 |
Deferred other income | 0 | 160 |
Total current liabilities | 26,868 | 25,697 |
Long-term debt, net | 72,680 | 72,500 |
Other liabilities | 1,091 | 181 |
Total liabilities | 100,639 | 98,378 |
Stockholders' equity: | ||
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2019 and December 31, 2018; 41,264,422 and 41,227,530 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 41 | 41 |
Additional paid-in capital | 439,167 | 436,554 |
Accumulated deficit | (346,801) | (317,927) |
Accumulated other comprehensive loss | (54) | (57) |
Total stockholders' equity | 92,353 | 118,611 |
Total liabilities and stockholders' equity | $ 192,992 | $ 216,989 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (usd per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 200,000,000 | 200,000,000 |
Shares issued (in shares) | 41,227,530 | 41,227,530 |
Shares outstanding (in shares) | 41,227,530 | 41,227,530 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Total revenues | $ 4,476 | $ 865 |
Operating expenses: | ||
Licensing revenues | 738 | 200 |
Research and development | 4,562 | 1,701 |
Selling, general and administrative | 26,340 | 28,011 |
Total operating expenses | 31,640 | 29,912 |
Loss from operations | (27,164) | (29,047) |
Other (income) expense: | ||
Grant and other income | 0 | 189 |
Interest income | (684) | (476) |
Interest expense | 2,388 | 2,193 |
Foreign currency (gains) losses | 6 | (3) |
Net loss | $ (28,874) | $ (30,572) |
Net loss per share of common stock, basic and diluted (in USD per share) | $ (0.70) | $ (0.81) |
Weighted average common shares outstanding, basic and diluted (in shares) | 41,256,050 | 37,849,199 |
Net product revenues | ||
Total revenues | $ 3,976 | $ 865 |
Licensing revenues | ||
Total revenues | $ 500 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (28,874) | $ (30,572) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustment | 3 | 7 |
Comprehensive loss | $ (28,871) | $ (30,565) |
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 | 2,050 | 2,050 | |||
Exercised (in shares) | 106,502 | ||||
Exercise of stock options | 130 | 130 | |||
Foreign currency translation adjustment | 7 | 7 | |||
Net loss | (30,572) | (30,572) | |||
Shares outstanding (in shares) at Mar. 31, 2018 | 37,909,058 | ||||
Ending balance at Mar. 31, 2018 | 126,111 | $ 38 | 368,018 | (241,841) | (104) |
Shares outstanding (in shares) at Dec. 31, 2018 | 41,227,530 | ||||
Beginning balance at Dec. 31, 2018 | 118,611 | $ 41 | 436,554 | (317,927) | (57) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 2,425 | 2,425 | |||
Exercised (in shares) | 5,000 | ||||
Exercise of stock options | 15 | 15 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 31,892 | ||||
Issuance of common stock under employee stock purchase plan | 173 | 173 | |||
Foreign currency translation adjustment | 3 | 3 | |||
Net loss | (28,874) | (28,874) | |||
Shares outstanding (in shares) at Mar. 31, 2019 | 41,264,422 | ||||
Ending balance at Mar. 31, 2019 | $ 92,353 | $ 41 | $ 439,167 | $ (346,801) | $ (54) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (28,874) | $ (30,572) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 269 | 157 |
Stock-based compensation | 2,422 | 2,023 |
Amortization of debt discount and issuance costs | 113 | 73 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,483) | (2,049) |
Grants and other receivables | 118 | (225) |
Prepaid expenses and other assets | (1,342) | (118) |
Inventory | 1,419 | (1,543) |
Accounts payable | 584 | 3,723 |
Accrued expenses and other liabilities | (920) | 5,533 |
Cash used in operating activities | (29,694) | (22,998) |
Investing activities: | ||
Purchases of property and equipment | (168) | (382) |
Cash used in investing activities | (168) | (382) |
Financing activities: | ||
Proceeds from the sale of common stock | 0 | 0 |
Cash paid for financing costs | 0 | (1,823) |
Proceeds from issuance of common stock under employee stock purchase plan | 173 | 0 |
Proceeds from the exercise of stock options | 15 | 130 |
Cash provided by (used in) financing activities | 188 | (1,693) |
Effects of exchange rate changes on cash and cash equivalents | (6) | (1) |
Net increase in cash, cash equivalents and restricted cash | (29,680) | (25,074) |
Cash, cash equivalents and restricted cash at beginning of period | 201,011 | 234,875 |
Cash, cash equivalents and restricted cash at end of period | 171,331 | 209,801 |
Supplemental disclosure of noncash activities: | ||
Fixed asset purchases within accounts payable and accrued expenses | 146 | 303 |
Financing costs within accounts payable and accrued expenses | 0 | 671 |
Recognition of initial right-of-use assets | 2,484 | 0 |
Recognition of initial lease liabilities | $ 2,961 | $ 0 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 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 Optinose 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 retail channels in April 2018. |
Liquidity
Liquidity | 3 Months Ended |
Mar. 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, pursuing regulatory approvals and most recently, preparing for and launching XHANCE. As of March 31, 2019 , the Company had cash and cash equivalents of $171,316 . On June 11, 2018, the Company and certain stockholders closed an underwritten public offering (the Offering) of 5,750,000 shares of Company common stock (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. 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 (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. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies The accompanying unaudited interim consolidated financial statements have been prepared in conformity with US generally accepted accounting principles (GAAP). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB). In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the financial statements) considered necessary to present fairly the Company's financial position as of March 31, 2019 and its results of operations for the three months ended March 31, 2019 and 2018 and cash flows for the three months ended March 31, 2019 and 2018 . Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019 . The unaudited interim financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. The accompanying unaudited interim financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2018 contained in the Company’s annual report on Form 10-K for the year ended December 31, 2018 , filed with the SEC on March 6, 2019. Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim consolidated financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and accounts receivable.The Company generally invests its cash in deposits with high credit quality financial institutions. Additionally, the Company performs periodic evaluations of the relative credit standing of these financial institutions. The Company has exposure to credit risk in accounts receivable from sales of product. XHANCE is sold to wholesale pharmaceutical distributors and preferred pharmacy network partners, who, in turn, sell XHANCE to pharmacies, hospitals and other customers. Five customers represent approximately 73% of the Company's accounts receivable at March 31, 2019 and five customers represent approximately 71% of the Company's net product sales for the three months ended March 31, 2019 . Fair value of financial instruments At March 31, 2019 and December 31, 2018 , the Company's financial instruments included cash and cash equivalents, accounts receivable, grants receivable, inventory, accounts payable and accrued expenses. The carrying amounts reported in the Company's financial statements for these instruments approximate their respective fair values because of the short-term nature of these instruments. The Company also believes the carrying value of long-term debt approximates fair value at March 31, 2019 as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. At March 31, 2019 and December 31, 2018 , there were no financial assets or liabilities measured at fair value on a recurring basis. Restricted cash As of March 31, 2019 and December 31, 2018 , the restricted cash balance included in prepaid expenses and other assets was $15 and $20 , respectively. Net Product Revenues The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers , which was adopted on January 1, 2018. The Company recognizes revenue from product sales at the point the Customer obtains control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration. The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. The components of the Company’s variable consideration include the following: Provider Chargebacks and Discounts. Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Trade Discounts and Allowances. The Company generally provides Customers with discounts that include incentive fees which are explicitly stated in the Company’s contracts. These discounts are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized. 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 liability. The Company considers several factors in the estimation process, including expiration dates of product shipped to preferred pharmacy network partners and wholesalers, 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. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel inventories at the end of the reporting period. Payor Rebates. The Company contracts with certain third-party payors, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the plan or the organization with which it contracts. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Other Incentives. Other incentives that the Company offers include voluntary patient assistance programs, such as co-pay assistance programs, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors and coupon programs for cash payors. The calculation of the accruals 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 three months ended March 31, 2019, the Company's licensing revenues were generated pursuant to the terms of a single license agreement (the Inexia License Agreement) with Inexia (Inexia) (Note 8). The Inexia License Agreement includes licensed rights to patented technology, a non-refundable up-front payment, development and sales milestones as well as royalty payments. The Company analyzed the performance obligations under the Inexia License Agreement, 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 payment received of $500 as licensing revenue during the three months ended March 31, 2019 upon the delivery of the license performance obligation. Net income (loss) per common share Basic net income (loss) per common share is determined by dividing net income (loss) applicable to Common Stock holders by the weighted average common shares outstanding during the period. For the three months ended March 31, 2019 and 2018 , the outstanding Common Stock options, Common Stock warrants and shares to be issued under the Company's 2017 Employee Stock Purchase Plan have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, the weighted average shares used to calculate both basic and diluted net loss per share are the same. Diluted net loss per common share for the periods presented do not reflect the following potential common shares, as the effect would be antidilutive: March 31, 2019 2018 Stock options 7,777,367 6,309,453 Common stock warrants 1,866,831 1,890,489 Employee stock purchase plan 46,161 33,181 Total 9,690,359 8,233,123 Income taxes In accordance with ASC 270, Interim Reporting , and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three months ended March 31, 2019 and 2018 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. As of March 31, 2019 and December 31, 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. Recent accounting pronouncements 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 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. 2018-13, 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 is currently evaluating the potential impact of the adoption of this standard 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, 2019, and early adoption is 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 is effective for fiscal years beginning after December 15, 2018. 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 — Leases for further details. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following: March 31, December 31, 2018 Raw materials $ 1,903 $ 1,969 Work-in-process 1,682 2,344 Finished goods 2,131 2,819 Total inventory $ 5,716 $ 7,132 Inventories are stated at the lower of cost or net realizable value, as determined on a first-in, first-out, basis. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment, net, consisted of: March 31, December 31, Computer equipment and software $ 955 $ 833 Furniture and fixtures 391 389 Machinery and equipment 3,168 2,723 Leasehold improvements 605 609 Construction in process 29 481 5,148 5,035 Less: accumulated depreciation (1,433 ) (1,151 ) $ 3,715 $ 3,884 Depreciation expense was $269 and $156 for the three months ended March 31, 2019 and 2018 , respectively. In addition, depreciation expense of $66 and $8 was charged to inventory and prepaid expenses and other assets, respectively, during the three months ended March 31, 2019 , which represents depreciation expense related to equipment involved in the manufacturing process. |
Leases
Leases | 3 Months Ended |
Mar. 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 our 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 3 years . The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. 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 March 31, 2019 : Balance Sheet Line Item March 31, 2019 Non-current operating lease assets Other assets 2,380 Operating lease liabilities: Current operating lease liabilities Accrued expenses and other current liabilities $ 1,510 Non-current operating lease liabilities Other liabilities 1,091 Total operating lease liabilities $ 2,601 The depreciable lives of operating lease assets 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 March 31, 2019 are: March 31, 2019 Weighted average remaining lease term (years) 1.86 Weighted average discount rate 6.37 % 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 March 31, 2019 : March 31, 2019 2019 $ 1,227 2020 1,136 2021 401 Thereafter — Total undiscounted future minimum lease payments $ 2,764 Less: difference between undiscounted lease payments and discounted operating lease liabilities 163 Total operating lease liabilities $ 2,601 Operating lease payments include $44 related to options to extend lease terms that are reasonably certain of being exercised. Operating lease costs were $379 for the three months ended March 31, 2019 . Operating lease costs are included within selling, general and administrative expenses on the consolidated statements of operations. Cash paid for amounts included in the measurement of operating lease liabilities were $402 for the three months ended March 31, 2019 , and this amount is included in operating activities in the consolidated statements of cash flows. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of: March 31, December 31, Accrued expenses: Contract sales organization expenses $ 4,367 $ 4,482 Selling, general and administrative expenses 4,537 4,812 Research and development expenses 788 933 Payroll expenses 2,583 4,199 Product revenue allowances 4,630 2,856 Other 777 1,139 Total accrued expenses $ 17,682 $ 18,421 Other current liabilities: Lease liability $ 1,510 $ — Total other current liabilities $ 1,510 $ — Total accrued expenses and other current liabilities $ 19,192 $ 18,421 |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Research and Development [Abstract] | |
License Agreements | License Agreements AVP-825 License Agreement In July 2013, the Company's wholly owned subsidiary, OptiNose AS, entered into the AVP-825 License Agreement with 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 EDS 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 March 31, 2019 , under the terms of the AVP-825 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 three months ended March 31, 2019 and 2018 and does not expect any future revenue under the AVP-825 License Agreement. On December 10, 2018, the Company received written notice from Avanir of its election to terminate the AVP-825 License Agreement. As a result, the AVP-825 License Agreement terminated on March 10, 2019. The Company is evaluating options with respect to the future of Onzetra Xsail. Inexia License Agreement On January 31, 2019, OptiNose AS, a wholly owned subsidiary of the Company, entered into the Inexia License Agreement with Inexia. Under the terms of the Inexia License Agreement, Inexia paid the Company a $500 upfront payment. For each product developed under the Inexia License Agreement, the Company is eligible to receive up to $8,000 of development milestone payments and up to $37,000 of sales milestone payments. In addition, the Company is eligible to receive tiered, low-to-mid single digit royalties based on net sales of any products successfully developed and commercialized under the Inexia License Agreement. Other than the upfront payment, the Company does not anticipate the receipt of any milestone or royalty payments from Inexia in the near term. |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 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 immediately. The remaining $25,000 (the Delayed Draw Notes) may be issued between April 1, 2019 and August 14, 2019, subject to the Company achieving trailing four quarter net revenues (as calculated pursuant to the terms of the Senior Secured Note Purchase Agreement) of $15,000 and a pro forma ratio of total debt to trailing four quarter net revenues not exceeding 6.50 to 1.00 , and certain other conditions. The Senior Secured Notes bear interest at 9.0% plus the three-month London Inter-bank Offered Rate (LIBOR) rate, subject to a 1.0% floor and are scheduled to mature on June 29, 2023. The interest rate was 11.625% at March 31, 2019 . The Senior Secured Notes bore front-end fees of 1.0% of the aggregate principal amount, which were paid at issuance. The Company is also required to pay an exit fee of 2.0% of any principal payments (whether mandatory, voluntary, or at maturity) made throughout the term of the Senior Secured Note Purchase Agreement. The Company recorded interest expense of $2,388 and $2,193 during the three months ended March 31, 2019 and 2018 , respectively, in conjunction with the Senior Secured Notes. Interest expense included total coupon interest, exit fees, front end fees and the amortization of debt issuance costs. The front-end fees of $1,000 were recorded as debt discount at issuance and are being amortized to interest expense over the 5.5 year term of the loan. Additionally, back end fees of $2,000 are being amortized to interest expense and are recorded as an increase in the carrying amount throughout the term of the Senior Secured Notes. The Company also incurred $2,181 in debt issuance costs during the year ended December 31, 2017, which are also being amortized to interest expense over the term of the Senior Secured Notes. The long-term debt balance is comprised of the following: March 31, December 31, Face amount $ 75,000 $ 75,000 Front end fees (837 ) (872 ) Debt issuance costs (1,825 ) (1,902 ) Back end fees 342 274 Long-term debt, net $ 72,680 $ 72,500 |
Employee Benefit Plans
Employee Benefit Plans | 3 Months Ended |
Mar. 31, 2019 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | Employee Benefit Plans For US employees, the Company maintains a defined contribution 401(k) retirement plan. As of March 31, 2019 , approximately $40 is recorded in accrued liabilities related to the Company match. The Company's contributions are made in cash. For Norway and UK employees, the Company maintains defined contribution pension plans which meet statutory requirements of those jurisdictions. The Company incurred costs of $6 and $62 related to the pension plans for the three months ended March 31, 2019 and 2018 , respectively. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock On June 11, 2018, the Company and certain stockholders closed the 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. 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 March 31, 2019 . Common Stock warrants As of March 31, 2019 , the Company had warrants outstanding to purchase 1,866,831 shares of Common Stock with an exercise price of $8.16 . The warrants expire on November 1, 2020. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | Stock-based Compensation The Company recorded stock-based compensation expense related to stock options and shares issued under the Company's 2017 Employee Stock Purchase Plan (2017 Plan) in the following expense categories of its accompanying consolidated statements of operations for the three months ended March 31, 2019 and 2018 : Three Months Ended March 31, 2019 2018 Cost of product sales $ 21 $ 1 Research and development 243 239 General and administrative 2,158 1,783 $ 2,422 $ 2,023 In addition, stock-based compensation expense of $3 and $23 was charged to inventory and prepaid expenses and other assets, respectively, during the three months ended March 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. Stock Options The Company has issued serviced-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 Company's board of directors. Vesting generally occurs over a period of not greater than four years. Performance-based options may vest upon the achievement of certain milestones in connection with the Company's development programs. Additionally, the Company has issued stock options in excess of the fair market value of Common Stock on the issuance date that were only exercisable upon a change in control or upon or after an initial public offering. As of March 31, 2019 , all of the performance conditions related to performance-based stock options issued by the Company have been achieved. The following table summarizes the activity related to stock option grants to employees and nonemployees for the three months ended March 31, 2019 : Shares Weighted average exercise price per share Weighted average remaining contractual life Outstanding at December 31, 2018 6,182,873 $ 10.60 6.67 Granted 1,686,800 7.49 Exercised (5,000 ) 3.05 Expired — — Forfeited (87,306 ) 10.53 Outstanding at March 31, 2019 7,777,367 $ 9.93 6.95 Exercisable at March 31, 2019 4,016,100 $ 8.44 4.92 Vested and expected to vest at March 31, 2019 7,777,367 $ 9.93 6.95 During the three months ended March 31, 2019 , stock options to purchase 1,686,800 shares of Common Stock were granted to employees and directors and generally vest over four years. The stock options had an estimated weighted average grant date fair value of $4.67 . During the three months ended March 31, 2018 , stock options to purchase 191,879 shares of Common Stock were granted to employees that generally vest over four years. The stock options had an estimated weighted average grant date fair value of $12.18 . The grant date fair value of each stock option grant was estimated at the time of grant using the Black-Scholes option-pricing model using the following weighted average assumptions: Three Months Ended March 31, 2019 2018 Risk free interest rate 2.57 % 2.59 % Expected term (in years) 6.08 6.05 Expected volatility 67.14 % 76.21 % Annual dividend yield 0.00 % 0.00 % Fair value of common stock $ 4.67 $ 17.96 At March 31, 2019 , the unrecognized compensation cost related to unvested stock options expected to vest was $25,500 . This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.93 years. 2017 Employee Stock Purchase Plan Under the 2017 Plan, shares of Common Stock may be purchased by eligible employees who elect to participate in the 2017 Plan at 85% of the lower of the fair market value of Common Stock on the first or last day of designated offering periods.The Company recognized stock-based compensation expense of $ 114 and $156 during the three months ended March 31, 2019 and 2018 , respectively, related to the 2017 Plan. In July 2018, the Company issued 53,137 shares of Common Stock related to the offering periods ended June 30, 2018. In January 2019, the Company issued 31,892 shares of Common Stock related to the offering period ended December 31, 2018. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Use of estimates | Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim consolidated financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. |
Fair value of financial instruments | Fair value of financial instruments At March 31, 2019 and December 31, 2018 , the Company's financial instruments included cash and cash equivalents, accounts receivable, grants receivable, inventory, accounts payable and accrued expenses. The carrying amounts reported in the Company's financial statements for these instruments approximate their respective fair values because of the short-term nature of these instruments. The Company also believes the carrying value of long-term debt approximates fair value at March 31, 2019 as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. |
Net income (loss) per common share | Net income (loss) per common share Basic net income (loss) per common share is determined by dividing net income (loss) applicable to Common Stock holders by the weighted average common shares outstanding during the period. For the three months ended March 31, 2019 and 2018 , the outstanding Common Stock options, Common Stock warrants and shares to be issued under the Company's 2017 Employee Stock Purchase Plan have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, the weighted average shares used to calculate both basic and diluted net loss per share are the same. |
Income Taxes | Income taxes In accordance with ASC 270, Interim Reporting , and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three months ended March 31, 2019 and 2018 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. As of March 31, 2019 and December 31, 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. |
Recent accounting pronouncements | Recent accounting pronouncements 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 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. 2018-13, 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 is currently evaluating the potential impact of the adoption of this standard 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, 2019, and early adoption is 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 is effective for fiscal years beginning after December 15, 2018. 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 — Leases for further details. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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: March 31, 2019 2018 Stock options 7,777,367 6,309,453 Common stock warrants 1,866,831 1,890,489 Employee stock purchase plan 46,161 33,181 Total 9,690,359 8,233,123 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: March 31, December 31, 2018 Raw materials $ 1,903 $ 1,969 Work-in-process 1,682 2,344 Finished goods 2,131 2,819 Total inventory $ 5,716 $ 7,132 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment, net, consisted of: March 31, December 31, Computer equipment and software $ 955 $ 833 Furniture and fixtures 391 389 Machinery and equipment 3,168 2,723 Leasehold improvements 605 609 Construction in process 29 481 5,148 5,035 Less: accumulated depreciation (1,433 ) (1,151 ) $ 3,715 $ 3,884 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 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 March 31, 2019 : Balance Sheet Line Item March 31, 2019 Non-current operating lease assets Other assets 2,380 Operating lease liabilities: Current operating lease liabilities Accrued expenses and other current liabilities $ 1,510 Non-current operating lease liabilities Other liabilities 1,091 Total operating lease liabilities $ 2,601 The Company's weighted average remaining lease term and weighted average discount rate for operating leases as of March 31, 2019 are: March 31, 2019 Weighted average remaining lease term (years) 1.86 Weighted average discount rate 6.37 % |
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 March 31, 2019 : March 31, 2019 2019 $ 1,227 2020 1,136 2021 401 Thereafter — Total undiscounted future minimum lease payments $ 2,764 Less: difference between undiscounted lease payments and discounted operating lease liabilities 163 Total operating lease liabilities $ 2,601 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses and other current liabilities consisted of: March 31, December 31, Accrued expenses: Contract sales organization expenses $ 4,367 $ 4,482 Selling, general and administrative expenses 4,537 4,812 Research and development expenses 788 933 Payroll expenses 2,583 4,199 Product revenue allowances 4,630 2,856 Other 777 1,139 Total accrued expenses $ 17,682 $ 18,421 Other current liabilities: Lease liability $ 1,510 $ — Total other current liabilities $ 1,510 $ — Total accrued expenses and other current liabilities $ 19,192 $ 18,421 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The long-term debt balance is comprised of the following: March 31, December 31, Face amount $ 75,000 $ 75,000 Front end fees (837 ) (872 ) Debt issuance costs (1,825 ) (1,902 ) Back end fees 342 274 Long-term debt, net $ 72,680 $ 72,500 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of allocated stock-based compensation expense | The Company recorded stock-based compensation expense related to stock options and shares issued under the Company's 2017 Employee Stock Purchase Plan (2017 Plan) in the following expense categories of its accompanying consolidated statements of operations for the three months ended March 31, 2019 and 2018 : Three Months Ended March 31, 2019 2018 Cost of product sales $ 21 $ 1 Research and development 243 239 General and administrative 2,158 1,783 $ 2,422 $ 2,023 |
Schedule of stock option activity | The following table summarizes the activity related to stock option grants to employees and nonemployees for the three months ended March 31, 2019 : Shares Weighted average exercise price per share Weighted average remaining contractual life Outstanding at December 31, 2018 6,182,873 $ 10.60 6.67 Granted 1,686,800 7.49 Exercised (5,000 ) 3.05 Expired — — Forfeited (87,306 ) 10.53 Outstanding at March 31, 2019 7,777,367 $ 9.93 6.95 Exercisable at March 31, 2019 4,016,100 $ 8.44 4.92 Vested and expected to vest at March 31, 2019 7,777,367 $ 9.93 6.95 |
Schedule of fair value options using Black-Scholes pricing model | The grant date fair value of each stock option grant was estimated at the time of grant using the Black-Scholes option-pricing model using the following weighted average assumptions: Three Months Ended March 31, 2019 2018 Risk free interest rate 2.57 % 2.59 % Expected term (in years) 6.08 6.05 Expected volatility 67.14 % 76.21 % Annual dividend yield 0.00 % 0.00 % Fair value of common stock $ 4.67 $ 17.96 |
Liquidity (Details)
Liquidity (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 11, 2018 | Mar. 31, 2019 | Dec. 31, 2018 |
Subsidiary, Sale of Stock [Line Items] | |||
Cash and cash equivalents | $ 171,316 | $ 200,990 | |
Public Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Number of shares issued (in shares) | 5,750,000 | ||
Price per share (usd per share) | $ 22.25 | ||
Consideration received on transaction | $ 59,917 | ||
Discounts | 3,678 | ||
Offering expenses | $ 373 | ||
The Company | Public Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Number of shares issued (in shares) | 2,875,000 | ||
Certain Stockholders | Public Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Number of shares issued (in shares) | 2,875,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Concentration of credit risk (Details) - Customer Concentration Risk | 3 Months Ended |
Mar. 31, 2019customers | |
Accounts Receivable | |
Concentration Risk [Line Items] | |
Number of clients | 5 |
Concentration risk | 73.00% |
Sales Revenue, Net | |
Concentration Risk [Line Items] | |
Number of clients | 5 |
Concentration risk | 71.00% |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Licensing (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
License Agreement Terms | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Revenue recognized | $ 500 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Antidilutive shares excluded from earnings per share (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share | 9,690,359 | 8,233,123 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share | 7,777,367 | 6,309,453 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share | 1,866,831 | 1,890,489 |
Employee stock purchase plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of earnings per share | 46,161 | 33,181 |
Basis of Presentation and Sum_7
Basis of Presentation and Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Prepaid Expenses and Other Current Assets | Accounting Standards Update 2016-18 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Restricted cash | $ 15 | $ 20 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,903 | $ 1,969 |
Work-in-process | 1,682 | 2,344 |
Finished goods | 2,131 | 2,819 |
Total inventory | $ 5,716 | $ 7,132 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,148 | $ 5,035 |
Less: accumulated depreciation | (1,433) | (1,151) |
Property and equipment, net | 3,715 | 3,884 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 955 | 833 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 391 | 389 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,168 | 2,723 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 605 | 609 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 29 | $ 481 |
Property and Equipment (Narrati
Property and Equipment (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation | $ 269 | $ 156 | |
Accumulated depreciation | 1,433 | $ 1,151 | |
Inventories | |||
Property, Plant and Equipment [Line Items] | |||
Accumulated depreciation | 66 | ||
Prepaid Expenses and Other Current Assets | |||
Property, Plant and Equipment [Line Items] | |||
Accumulated depreciation | $ 8 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Jan. 01, 2019 | |
Leases [Abstract] | ||
Operating lease asset | $ 2,411 | |
Operating lease liability | $ 2,601 | $ 2,887 |
Operating lease term | 3 years | |
Cost for extension | $ 44 | |
Lease cost | 379 | |
Operating lease payments | $ 402 |
Leases - Operating Lease Assets
Leases - Operating Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
Non-current operating lease assets | $ 2,380 | ||
Current operating lease liabilities | 1,510 | $ 0 | |
Non-current operating lease liabilities | 1,091 | ||
Total operating lease liabilities | $ 2,601 | $ 2,887 |
Leases - Weighted Average Remai
Leases - Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Details) | Mar. 31, 2019 |
Leases [Abstract] | |
Weighted average remaining lease term (years) | 1 year 10 months 10 days |
Weighted average discount rate | 6.37% |
Leases - Operating Lease Maturi
Leases - Operating Lease Maturities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 |
Operating leases | ||
2019 | $ 1,227 | |
2020 | 1,136 | |
2021 | 401 | |
Thereafter | 0 | |
Total undiscounted future minimum lease payments | 2,764 | |
Less: difference between undiscounted lease payments and discounted operating lease liabilities | 163 | |
Total operating lease liabilities | $ 2,601 | $ 2,887 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Accrued expenses: | ||
Contract sales organization expenses | $ 4,367 | $ 4,482 |
Selling, general and administrative expenses | 4,537 | 4,812 |
Research and development expenses | 788 | 933 |
Payroll expenses | 2,583 | 4,199 |
Product revenue allowances | 4,630 | 2,856 |
Other | 777 | 1,139 |
Total accrued expenses | 17,682 | 18,421 |
Other current liabilities: | ||
Lease liability | 1,510 | 0 |
Total other current liabilities | 1,510 | 0 |
Total accrued expenses and other current liabilities | $ 19,192 | $ 18,421 |
License Agreements (Details)
License Agreements (Details) - License Agreement Terms - USD ($) | Jan. 31, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2018 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Aggregate cash payments received from license agreement | $ 70,000,000 | |||
Development Milestone Eligibility | $ 8,000,000 | |||
Potential proceeds upon achievement of milestones | $ 37,000,000 | |||
Licensing revenue | $ 0 | $ 0 |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) | 3 Months Ended | 4 Months Ended | |||
Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Aug. 14, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 29, 2017USD ($)quarter | |
Debt Instrument [Line Items] | |||||
Total revenues | $ 4,476,000 | $ 865,000 | |||
Debt amortization period | 5 years 6 months | ||||
Interest expense, back end fees | $ 2,000,000 | ||||
Debt issuance costs | $ 2,181,000 | ||||
Senior Notes | |||||
Debt Instrument [Line Items] | |||||
Amortization of debt discount | 1,000,000 | ||||
Senior Notes | Note Purchase Agreement | |||||
Debt Instrument [Line Items] | |||||
Unused borrowing capacity | $ 100,000,000 | ||||
Face amount | $ 75,000,000 | $ 75,000,000 | |||
Stated interest rate | 11.625% | 9.00% | |||
Upfront fee | 1.00% | ||||
Exit fee | 2.00% | ||||
Interest expense, debt | $ 2,388,000 | $ 2,193,000 | |||
Senior Notes | Note Purchase Agreement | London Interbank Offered Rate (LIBOR) | |||||
Debt Instrument [Line Items] | |||||
Interest rate floor | 1.00% | ||||
Senior Notes | Note Purchase Agreement - Delayed Draw Notes | |||||
Debt Instrument [Line Items] | |||||
Unused borrowing capacity | $ 25,000,000 | ||||
Number of trailing quarters | quarter | 4 | ||||
Scenario, Forecast | Senior Notes | Note Purchase Agreement - Delayed Draw Notes | |||||
Debt Instrument [Line Items] | |||||
Total revenues | $ 15,000,000 | ||||
Total debt to trailing four quarter net revenues | 6.50 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long Term Debt (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Long-term debt, net | $ 72,680,000 | $ 72,500,000 |
Note Purchase Agreement | Senior Notes | ||
Debt Instrument [Line Items] | ||
Face amount | 75,000,000 | 75,000,000 |
Front end fees | (837,000) | (872,000) |
Debt issuance costs | (1,825,000) | (1,902,000) |
Back end fees | 342,000 | 274,000 |
Long-term debt, net | $ 72,680,000 | $ 72,500,000 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Defined contribution plan, cost | $ 40 | |
Foreign Plan | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Defined contribution plan, cost | $ 6 | $ 62 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) $ / shares in Units, $ in Thousands | Jun. 11, 2018USD ($)$ / sharesshares | Mar. 31, 2019vote$ / sharesshares |
Class of Stock [Line Items] | ||
Vote per share | vote | 1 | |
Dividends declared (usd per share) | $ / shares | $ 0 | |
Common stock warrants outstanding (in shares) | 1,866,831 | |
Common stock warrant exercise price (in dollars per share) | $ / shares | $ 8.16 | |
Public Offering | ||
Class of Stock [Line Items] | ||
Number of shares issued (in shares) | 5,750,000 | |
Price per share (usd per share) | $ / shares | $ 22.25 | |
Consideration received on transaction | $ | $ 59,917 | |
Discounts | $ | 3,678 | |
Offering expenses | $ | $ 373 | |
The Company | Public Offering | ||
Class of Stock [Line Items] | ||
Number of shares issued (in shares) | 2,875,000 | |
Certain Stockholders | Public Offering | ||
Class of Stock [Line Items] | ||
Number of shares issued (in shares) | 2,875,000 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 2,422 | $ 2,023 |
Cost of product sales | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 21 | 1 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 243 | 239 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 2,158 | $ 1,783 |
Inventories | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 3 | |
Prepaid Expenses and Other Current Assets | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 23 |
Stock-based Compensation - (Nar
Stock-based Compensation - (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jan. 31, 2019 | Jul. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 2,422 | $ 2,023 | ||
Shares issued (in shares) | 31,892 | 53,137 | ||
Service Based Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Award vesting period | 4 years | 4 years | ||
Granted (in shares) | 1,686,800 | 191,879 | ||
Fair value of common stock (in dollars per share) | $ 4.67 | $ 12.18 | ||
Unrecognized compensation cost | $ 25,500 | |||
Unrecognized compensation, estimated weighted-average amortization period | 2 years 11 months 6 days | |||
2010 Stock Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Plan options contractual life | 10 years | |||
Award vesting period | 4 years | |||
2017 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 114 | $ 156 |
Stock-based Compensation - Serv
Stock-based Compensation - Service-based stock options (Details) - Service Based Stock Options - $ / shares | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | |
Service-based stock options activity | |||
Shares outstanding, beginning (in shares) | 6,182,873 | ||
Granted (in shares) | 1,686,800 | 191,879 | |
Exercised (in shares) | (5,000) | ||
Expired (in shares) | 0 | ||
Forfeited (in shares) | (87,306) | ||
Shares outstanding, ending (in shares) | 7,777,367 | ||
Exercisable at September 30, 2017 (in shares) | 4,016,100 | ||
Vested and expected to vest at September 30, 2017 (in shares) | 7,777,367 | ||
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) | 7.49 | ||
Exercised, Weighted average exercise price (in dollars per share) | 3.05 | ||
Expired, Weighted average exercise price (in dollars per share) | 0 | ||
Forfeited, Weighted average exercise price (in dollars per share) | 10.53 | ||
Ending balance, Weighted average exercise price (in dollars per share) | 9.93 | ||
Options exercisable, Weighted average exercise price per share (in dollars per share) | 8.44 | ||
Vested and expected to vest, Weighted average exercise price per share (in dollars per share) | $ 9.93 | ||
Service-based stock options, additional disclosures | |||
Options outstanding, Weighted average remaining contractual life | 6 years 11 months 12 days | 6 years 8 months 1 day | |
Options exercisable, Weighted average remaining contractual life | 4 years 11 months 1 day | ||
Vested and expected to vest, Weighted average remaining contractual life | 6 years 11 months 12 days |
Stock-based Compensation - Blac
Stock-based Compensation - Black-Scholes pricing model options (Details) - Stock options - $ / shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 2.57% | 2.59% |
Expected term (in years) | 6 years 30 days | 6 years 18 days |
Expected volatility | 67.14% | 76.21% |
Annual dividend yield | 0.00% | 0.00% |
Fair value of common stock (in dollars per share) | $ 4.67 | $ 17.96 |