Document and Entity Information
Document and Entity Information Document - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 08, 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 | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 41,581,666 | |
Entity Emerging Growth Company | true | |
Entity Small Business | true | |
Entity Ex Transition Period | true | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 125,490 | $ 200,990 |
Accounts receivable, net | 10,746 | 2,310 |
Grants and other receivables | 232 | 242 |
Inventory | 4,404 | 7,132 |
Prepaid expenses and other current assets | 3,230 | 2,183 |
Total current assets | 144,102 | 212,857 |
Property and equipment, net | 3,261 | 3,884 |
Other assets | 2,014 | 248 |
Total assets | 149,377 | 216,989 |
Current liabilities: | ||
Accounts payable | 5,112 | 7,116 |
Accrued expenses and other current liabilities | 24,850 | 18,421 |
Deferred other income | 0 | 160 |
Total current liabilities | 29,962 | 25,697 |
Long-term debt, net | 74,266 | 72,500 |
Other liabilities | 631 | 181 |
Total liabilities | 104,859 | 98,378 |
Stockholders' equity: | ||
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2019 and December 31, 2018; 41,488,370 and 41,227,530 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 41 | 41 |
Additional paid-in capital | 447,541 | 436,554 |
Accumulated deficit | (402,985) | (317,927) |
Accumulated other comprehensive loss | (79) | (57) |
Total stockholders' equity | 44,518 | 118,611 |
Total liabilities and stockholders' equity | $ 149,377 | $ 216,989 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 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) | 41,488,370 | 41,227,530 |
Shares outstanding (in shares) | 41,488,370 | 41,227,530 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Total revenues | $ 12,397 | $ 1,902 | $ 23,550 | $ 4,042 |
Costs and expenses: | ||||
Cost of product sales | 1,389 | 319 | 3,216 | 870 |
Research and development | 5,547 | 2,989 | 15,404 | 6,736 |
Selling, general and administrative | 25,270 | 22,086 | 77,610 | 71,957 |
Total operating expenses | 32,206 | 25,394 | 96,230 | 79,563 |
Loss from operations | (19,809) | (23,492) | (72,680) | (75,521) |
Other (income) expense: | ||||
Grant and other income | 0 | (42) | 0 | (374) |
Interest income | (559) | (680) | (1,959) | (1,738) |
Interest expense | 2,372 | 2,361 | 7,148 | 6,855 |
Foreign currency (gains) losses | 31 | (8) | 34 | 13 |
Loss on extinguishment of debt | 7,155 | 0 | 7,155 | 0 |
Net loss | $ (28,808) | $ (25,123) | $ (85,058) | $ (80,277) |
Net loss per share of common stock, basic and diluted (in USD per share) | $ (0.69) | $ (0.61) | $ (2.06) | $ (2.04) |
Weighted average common shares outstanding, basic and diluted (in shares) | 41,454,181 | 41,207,167 | 41,341,570 | 39,260,903 |
Net product revenues | ||||
Total revenues | $ 8,667 | $ 1,902 | $ 19,320 | $ 4,042 |
Licensing revenues | ||||
Total revenues | $ 3,730 | $ 0 | $ 4,230 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (28,808) | $ (25,123) | $ (85,058) | $ (80,277) |
Other comprehensive (loss) income: | ||||
Foreign currency translation adjustment | (12) | 13 | (22) | 34 |
Comprehensive loss | $ (28,820) | $ (25,110) | $ (85,080) | $ (80,243) |
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 |
Beginning balance (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 | |||
Exercise of common stock options (in shares) | 106,502 | ||||
Exercise of common stock options | 130 | 130 | |||
Foreign currency translation adjustment | 7 | 7 | |||
Net loss | (30,572) | (30,572) | |||
Ending balance at Mar. 31, 2018 | 126,111 | $ 38 | 368,018 | (241,841) | (104) |
Ending balance (in shares) at Mar. 31, 2018 | 37,909,058 | ||||
Beginning balance (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] | |||||
Net loss | (80,277) | ||||
Ending balance at Sep. 30, 2018 | 142,732 | $ 41 | 434,312 | (291,545) | (76) |
Ending balance (in shares) at Sep. 30, 2018 | 41,227,530 | ||||
Beginning balance (in shares) at Mar. 31, 2018 | 37,909,058 | ||||
Beginning balance at Mar. 31, 2018 | 126,111 | $ 38 | 368,018 | (241,841) | (104) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 2,135 | 2,135 | |||
Sale of common stock, net of issuance costs (in shares) | 2,875,000 | ||||
Sale of common stock, net of issuance costs | 59,926 | $ 3 | 59,923 | ||
Exercise of common stock options (in shares) | 330,401 | ||||
Exercise of common stock options | 727 | 727 | |||
Exercise of warrants (in shares) | 7,098 | ||||
Exercise of warrants | 0 | ||||
Foreign currency translation adjustment | 15 | 15 | |||
Net loss | (24,581) | (24,581) | |||
Ending balance at Jun. 30, 2018 | 164,333 | $ 41 | 430,803 | (266,422) | (89) |
Ending balance (in shares) at Jun. 30, 2018 | 41,121,557 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 2,209 | 2,209 | |||
Exercise of common stock options (in shares) | 45,287 | ||||
Exercise of common stock options | 561 | 561 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 53,137 | ||||
Issuance of common stock under employee stock purchase plan | 739 | 739 | |||
Exercise of warrants (in shares) | 7,549 | ||||
Exercise of warrants | 0 | ||||
Foreign currency translation adjustment | 13 | 13 | |||
Net loss | (25,123) | (25,123) | |||
Ending balance at Sep. 30, 2018 | 142,732 | $ 41 | 434,312 | (291,545) | (76) |
Ending balance (in shares) at Sep. 30, 2018 | 41,227,530 | ||||
Beginning balance (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 | |||
Exercise of common stock options (in shares) | 5,000 | ||||
Exercise of common 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) | |||
Ending balance at Mar. 31, 2019 | 92,353 | $ 41 | 439,167 | (346,801) | (54) |
Ending balance (in shares) at Mar. 31, 2019 | 41,264,422 | ||||
Beginning balance (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] | |||||
Net loss | (85,058) | ||||
Ending balance at Sep. 30, 2019 | 44,518 | $ 41 | 447,541 | (402,985) | (79) |
Ending balance (in shares) at Sep. 30, 2019 | 41,488,370 | ||||
Beginning balance (in shares) at Mar. 31, 2019 | 41,264,422 | ||||
Beginning balance at Mar. 31, 2019 | 92,353 | $ 41 | 439,167 | (346,801) | (54) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 2,716 | 2,716 | |||
Exercise of common stock options (in shares) | 88,587 | ||||
Exercise of common stock options | 354 | 354 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 77,909 | ||||
Issuance of common stock under employee stock purchase plan | 439 | 439 | |||
Foreign currency translation adjustment | (13) | (13) | |||
Net loss | (27,376) | (27,376) | |||
Ending balance at Jun. 30, 2019 | 68,473 | $ 41 | 442,676 | (374,177) | (67) |
Ending balance (in shares) at Jun. 30, 2019 | 41,430,918 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock compensation expense | 2,469 | 2,469 | |||
Exercise of common stock options (in shares) | 57,452 | ||||
Exercise of common stock options | 172 | 172 | |||
Issuance of warrants | 2,224 | 2,224 | |||
Foreign currency translation adjustment | (12) | (12) | |||
Net loss | (28,808) | (28,808) | |||
Ending balance at Sep. 30, 2019 | $ 44,518 | $ 41 | $ 447,541 | $ (402,985) | $ (79) |
Ending balance (in shares) at Sep. 30, 2019 | 41,488,370 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities: | ||
Net loss | $ (85,058) | $ (80,277) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 878 | 326 |
Stock-based compensation | 7,552 | 6,325 |
Amortization of debt discount and issuance costs | 382 | 291 |
Loss on extinguishment of debt | 7,155 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (8,435) | (2,923) |
Grants and other receivables | 10 | (136) |
Prepaid expenses and other assets | (221) | (380) |
Inventory | 2,753 | (4,686) |
Accounts payable | (1,928) | 2,566 |
Accrued expenses and other liabilities | 4,203 | 7,271 |
Cash used in operating activities | (72,709) | (71,623) |
Investing activities: | ||
Purchases of property and equipment | (485) | (1,450) |
Cash used in investing activities | (485) | (1,450) |
Financing activities: | ||
Proceeds from the sale of common stock | 0 | 63,969 |
Proceeds from long-term debt | 77,596 | 0 |
Proceeds from the issuance of warrants | 2,404 | 0 |
Cash paid for financing costs | (3,277) | (6,464) |
Proceeds from issuance of common stock under employee stock purchase plan | 612 | 739 |
Proceeds from the exercise of stock options | 542 | 1,418 |
Repayment of Athyrium debt facility | (80,179) | 0 |
Cash (used in) provided by financing activities | (2,302) | 59,662 |
Effects of exchange rate changes on cash and cash equivalents | (11) | 41 |
Net decrease in cash, cash equivalents and restricted cash | (75,507) | (13,370) |
Cash, cash equivalents and restricted cash at beginning of period | 201,011 | 234,875 |
Cash, cash equivalents and restricted cash at end of period | 125,504 | 221,505 |
Supplemental disclosure of noncash activities: | ||
Fixed asset purchases within accounts payable and accrued expenses | 17 | 172 |
Fixed asset additions acquired through tenant allowance | 0 | 361 |
Financing costs within accounts payable and accrued expenses | 280 | 82 |
Recognition of initial right-of-use assets | 2,479 | 0 |
Recognition of initial lease liabilities | $ 2,956 | $ 0 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 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 | 9 Months Ended |
Sep. 30, 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 in the US. As of September 30, 2019 , the Company had cash and cash equivalents of $125,490 . 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. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 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 September 30, 2019 and its results of operations for the three and nine months ended September 30, 2019 and 2018 and cash flows for the nine months ended September 30, 2019 and 2018 . Operating results for the three and nine months ended September 30, 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 XHANCE. XHANCE is sold to wholesale pharmaceutical distributors and preferred pharmacy network partners (collectively, Customers), who, in turn, sell XHANCE to pharmacies, hospitals, patients and other customers. Five Customers represent approximately 67% of the Company's accounts receivable at September 30, 2019 and five Customers represent approximately 62% and 65% of the Company's net product sales for the three and nine months ended September 30, 2019 , respectively. Fair value of financial instruments At September 30, 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 September 30, 2019 as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. At September 30, 2019 and December 31, 2018 , there were no financial assets or liabilities measured at fair value on a recurring basis. Restricted cash As of September 30, 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 (ASC 606), which was adopted on January 1, 2018. The Company recognizes revenue from XHANCE sales at the point Customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration. The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. The components of the Company’s variable consideration include the following: Provider Chargebacks and Discounts. Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Trade Discounts and Allowances. The Company generally provides Customers with discounts that include incentive fees which are explicitly stated in the Company’s contracts. These discounts are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized. 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 product that may be returned and presents this amount as a reduction of revenue in the period the related product revenue is recognized, in addition to establishing a liability. The Company considers several factors in the estimation process, including expiration dates of product shipped to Customers, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors. Government Rebates. The Company is subject to discount obligations under state Medicaid programs and Medicare. Reserves related to these discount obligations are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel inventories at the end of the reporting period. Payor Rebates. The Company contracts with certain third-party payors, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the plan or the organization with which it contracts. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Patient Assistance. Other programs that the Company offers include voluntary co-pay patient assistance programs intended to provide financial assistance to 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 nine months ended September 30, 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 nine months ended September 30, 2019 upon the delivery of the license performance obligations. Net income (loss) per common share Basic net income (loss) per common share is determined by dividing net income (loss) applicable to Company common stock (Common Stock) holders by the weighted average common shares outstanding during the period. For the three and nine months ended September 30, 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: September 30, 2019 2018 Stock options 7,748,519 6,138,373 Common stock warrants 2,677,188 1,866,831 Employee stock purchase plan 48,279 18,507 Total 10,473,986 8,023,711 Income taxes In accordance with ASC 270, Interim Reporting , and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and nine months ended September 30, 2019 and 2018 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. As of September 30, 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, 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 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 for further details. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following: September 30, December 31, 2018 Raw materials $ 1,438 $ 1,969 Work-in-process 1,081 2,344 Finished goods 1,885 2,819 Total inventory $ 4,404 $ 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 | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment, net, consisted of the following: September 30, December 31, Computer equipment and software $ 1,108 $ 833 Furniture and fixtures 363 389 Machinery and equipment 3,114 2,723 Leasehold improvements 609 609 Construction in process 66 481 5,260 5,035 Less: accumulated depreciation (1,999 ) (1,151 ) $ 3,261 $ 3,884 Depreciation expense was $286 and $153 for the three months ended September 30, 2019 and 2018 , respectively. Depreciation expense was $877 and $325 for the nine months ended September 30, 2019 and 2018 , respectively. In addition, depreciation expense of $90 and $57 was charged to inventory and prepaid expenses and other assets, respectively, as of September 30, 2019 , which represents depreciation expense related to equipment involved in the manufacturing process. |
Leases
Leases | 9 Months Ended |
Sep. 30, 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 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 September 30, 2019 : Balance Sheet Line Item September 30, 2019 Non-current operating lease assets Other assets $ 1,852 Operating lease liabilities: Current operating lease liabilities Accrued expenses and other current liabilities 1,390 Non-current operating lease liabilities Other liabilities 631 Total operating lease liabilities $ 2,021 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 September 30, 2019 are: September 30, 2019 Weighted average remaining lease term (years) 1.4 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 September 30, 2019 : September 30, 2019 2019 $ 452 2020 1,191 2021 401 Thereafter — Total undiscounted future minimum lease payments 2,044 Less: difference between undiscounted lease payments and discounted operating lease liabilities 23 Total operating lease liabilities $ 2,021 Operating lease payments include $44 related to options to extend lease terms that are reasonably certain of being exercised. Operating lease costs were $494 and $1,563 for the three and nine months ended September 30, 2019 , respectively. Operating lease costs are included within selling, general and administrative expenses on the consolidated statements of operations. Cash paid for amounts included in the measurement of operating lease liabilities were $1,135 for the nine months ended September 30, 2019 , and this amount is included in operating activities in the consolidated statements of cash flows. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 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: September 30, December 31, Accrued expenses: Contract sales organization expenses $ — $ 4,482 Selling, general and administrative expenses 5,881 4,812 Research and development expenses 2,600 933 Payroll expenses 6,601 4,199 Product revenue allowances 6,963 2,856 Other 1,415 1,139 Total accrued expenses 23,460 18,421 Other current liabilities: Lease liability 1,390 — Total other current liabilities 1,390 — Total accrued expenses and other current liabilities $ 24,850 $ 18,421 |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 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 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 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 September 30, 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 and nine months ended September 30, 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. 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 third quarter of 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. Under the terms of the Inexia License Agreement, Inexia paid the Company a $500 upfront payment, which was recognized as license revenue in the first quarter of 2019. 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 | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term Debt 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 debt discount at issuance and are being amortized to interest expense over the five year term of the loan. The Company also incurred $ 4,836 in debt issuance costs, including $ 2,404 related to the fair value of the warrants, which are also being amortized to interest expense over the term of the Pharmakon Senior Secured Notes. The Company will incur additional debt issuance costs of 0.5% of the principal amount of the Delayed Draw Notes, if issued. 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, 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 September 30, 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 $2,372 and $2,361 during the three months ended September 30, 2019 and 2018 , respectively, and $7,148 and $6,855 during the nine months ended September 30, 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, exit fees, front end fees and the amortization of debt issuance costs. The long-term debt balance is comprised of the following: September 30, December 31, Face amount $ 80,000 $ 75,000 Front end fees (1,082 ) (872 ) Debt issuance costs (4,652 ) (1,902 ) Back end fees — 274 Long-term debt, net $ 74,266 $ 72,500 |
Employee Benefit Plans
Employee Benefit Plans | 9 Months Ended |
Sep. 30, 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 September 30, 2019 , approximately $151 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 the statutory requirements of those jurisdictions. The Company incurred costs related to the pension plans of $4 and $6 for the three months ended September 30, 2019 and 2018 , respectively, and $15 and $75 for the nine months ended September 30, 2019 and 2018 , respectively. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock On June 11, 2018, the Company and certain stockholders closed an underwritten public offering (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 $373 paid 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 September 30, 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: Nine Months Ended September 30, 2019 Risk free interest rate 1.67 % Expected term (in years) 3.00 Expected volatility 65.10 % Annual dividend yield 0.00 % Fair value of common stock $ 6.72 As of September 30, 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 | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [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 and nine months ended September 30, 2019 and 2018 : Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Cost of product sales $ 33 $ 3 $ 78 $ 6 Research and development 90 329 617 734 General and administrative 2,312 1,870 6,857 5,585 $ 2,435 $ 2,202 $ 7,552 $ 6,325 In addition, stock-based compensation expense of $62 and $29 was charged to inventory and prepaid expenses and other assets, respectively, during the nine months ended September 30, 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 September 30, 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 nine months ended September 30, 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 2,070,173 7.70 Exercised (151,039 ) 3.60 Expired — — Forfeited (353,488 ) 11.27 Outstanding at September 30, 2019 7,748,519 $ 9.93 6.64 Exercisable at September 30, 2019 4,425,938 $ 9.49 4.96 Vested and expected to vest at September 30, 2019 7,748,519 $ 9.93 6.64 During the nine months ended September 30, 2019 , stock options to purchase 2,070,173 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 $4.78 . During the nine months ended September 30, 2018 , stock options to purchase 423,892 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 $20.35 . 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: Nine Months Ended September 30, 2019 2018 Risk free interest rate 2.48 % 2.71 % Expected term (in years) 6.05 5.93 Expected volatility 67.03 % 74.61 % Annual dividend yield 0.00 % 0.00 % Fair value of common stock $ 7.70 $ 13.50 At September 30, 2019 , the unrecognized compensation cost related to unvested stock options expected to vest was $21,214 . This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.56 years. The following table summarizes the activity related to restricted stock units (RSUs) granted to employees for the nine months ended September 30, 2019 : Shares Balance at December 31, 2018 — Granted 20,600 Vested and settled — Expired/ forfeited/ canceled (20,600 ) Balance at September 30, 2019 — Expected to vest at September 30, 2019 — In April 2019, the Company granted 20,600 RSUs at a price of $10.20 , which forfeited during the three months ended September 30, 2019 . 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 $ 91 and $ 84 during the three months ended September 30, 2019 and 2018 , respectively, and $ 319 and $363 during the nine months ended September 30, 2019 and 2018 , respectively, related to the 2017 Plan. The Company issued 53,137 and 31,892 shares of Common Stock related to the offering periods ended June 30, 2018 and December 31, 2018, respectively. The Company issued 77,909 shares of Common Stock related to the offering period ended June 30, 2019. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 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. |
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. The Company has exposure to credit risk in accounts receivable from sales of XHANCE. XHANCE is sold to wholesale pharmaceutical distributors and preferred pharmacy network partners (collectively, Customers), who, in turn, sell XHANCE to pharmacies, hospitals, patients and other customers |
Fair value of financial instruments | Fair value of financial instruments At September 30, 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 September 30, 2019 as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. |
Restricted cash | Restricted cash As of September 30, 2019 and December 31, 2018 , the restricted cash balance included in prepaid expenses and other assets was $15 and $20 , respectively. |
Net product revenues and Licensing revenues | Net product revenues The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606), which was adopted on January 1, 2018. The Company recognizes revenue from XHANCE sales at the point Customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration. The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. The components of the Company’s variable consideration include the following: Provider Chargebacks and Discounts. Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Trade Discounts and Allowances. The Company generally provides Customers with discounts that include incentive fees which are explicitly stated in the Company’s contracts. These discounts are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized. 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 product that may be returned and presents this amount as a reduction of revenue in the period the related product revenue is recognized, in addition to establishing a liability. The Company considers several factors in the estimation process, including expiration dates of product shipped to Customers, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors. Government Rebates. The Company is subject to discount obligations under state Medicaid programs and Medicare. Reserves related to these discount obligations are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel inventories at the end of the reporting period. Payor Rebates. The Company contracts with certain third-party payors, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the plan or the organization with which it contracts. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Patient Assistance. Other programs that the Company offers include voluntary co-pay patient assistance programs intended to provide financial assistance to 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 nine months ended September 30, 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. |
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 Company common stock (Common Stock) holders by the weighted average common shares outstanding during the period. For the three and nine months ended September 30, 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 and nine months ended September 30, 2019 and 2018 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. As of September 30, 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, 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 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 for further details. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Antidilutive Shares Excluded From Computation of Net Loss 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: September 30, 2019 2018 Stock options 7,748,519 6,138,373 Common stock warrants 2,677,188 1,866,831 Employee stock purchase plan 48,279 18,507 Total 10,473,986 8,023,711 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: September 30, December 31, 2018 Raw materials $ 1,438 $ 1,969 Work-in-process 1,081 2,344 Finished goods 1,885 2,819 Total inventory $ 4,404 $ 7,132 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net, consisted of the following: September 30, December 31, Computer equipment and software $ 1,108 $ 833 Furniture and fixtures 363 389 Machinery and equipment 3,114 2,723 Leasehold improvements 609 609 Construction in process 66 481 5,260 5,035 Less: accumulated depreciation (1,999 ) (1,151 ) $ 3,261 $ 3,884 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 2019 : Balance Sheet Line Item September 30, 2019 Non-current operating lease assets Other assets $ 1,852 Operating lease liabilities: Current operating lease liabilities Accrued expenses and other current liabilities 1,390 Non-current operating lease liabilities Other liabilities 631 Total operating lease liabilities $ 2,021 The Company's weighted average remaining lease term and weighted average discount rate for operating leases as of September 30, 2019 are: September 30, 2019 Weighted average remaining lease term (years) 1.4 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 September 30, 2019 : September 30, 2019 2019 $ 452 2020 1,191 2021 401 Thereafter — Total undiscounted future minimum lease payments 2,044 Less: difference between undiscounted lease payments and discounted operating lease liabilities 23 Total operating lease liabilities $ 2,021 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of: September 30, December 31, Accrued expenses: Contract sales organization expenses $ — $ 4,482 Selling, general and administrative expenses 5,881 4,812 Research and development expenses 2,600 933 Payroll expenses 6,601 4,199 Product revenue allowances 6,963 2,856 Other 1,415 1,139 Total accrued expenses 23,460 18,421 Other current liabilities: Lease liability 1,390 — Total other current liabilities 1,390 — Total accrued expenses and other current liabilities $ 24,850 $ 18,421 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The long-term debt balance is comprised of the following: September 30, December 31, Face amount $ 80,000 $ 75,000 Front end fees (1,082 ) (872 ) Debt issuance costs (4,652 ) (1,902 ) Back end fees — 274 Long-term debt, net $ 74,266 $ 72,500 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 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: Nine Months Ended September 30, 2019 Risk free interest rate 1.67 % Expected term (in years) 3.00 Expected volatility 65.10 % Annual dividend yield 0.00 % Fair value of common stock $ 6.72 |
Schedule of Warrants Outstanding | As of September 30, 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) | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [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 and nine months ended September 30, 2019 and 2018 : Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Cost of product sales $ 33 $ 3 $ 78 $ 6 Research and development 90 329 617 734 General and administrative 2,312 1,870 6,857 5,585 $ 2,435 $ 2,202 $ 7,552 $ 6,325 |
Schedule of Stock Option Activity | The following table summarizes the activity related to stock option grants to employees and nonemployees for the nine months ended September 30, 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 2,070,173 7.70 Exercised (151,039 ) 3.60 Expired — — Forfeited (353,488 ) 11.27 Outstanding at September 30, 2019 7,748,519 $ 9.93 6.64 Exercisable at September 30, 2019 4,425,938 $ 9.49 4.96 Vested and expected to vest at September 30, 2019 7,748,519 $ 9.93 6.64 |
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: Nine Months Ended September 30, 2019 2018 Risk free interest rate 2.48 % 2.71 % Expected term (in years) 6.05 5.93 Expected volatility 67.03 % 74.61 % Annual dividend yield 0.00 % 0.00 % Fair value of common stock $ 7.70 $ 13.50 |
Schedule of Nonvested Restricted Stock Units Activity | The following table summarizes the activity related to restricted stock units (RSUs) granted to employees for the nine months ended September 30, 2019 : Shares Balance at December 31, 2018 — Granted 20,600 Vested and settled — Expired/ forfeited/ canceled (20,600 ) Balance at September 30, 2019 — Expected to vest at September 30, 2019 — |
Liquidity (Details)
Liquidity (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 125,490 | $ 200,990 |
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 | 9 Months Ended |
Sep. 30, 2019customer | Sep. 30, 2019customer | |
Accounts Receivable | ||
Concentration Risk [Line Items] | ||
Number of customers | 5 | 5 |
Concentration risk (as a percent) | 67.00% | |
Sales Revenue, Net | ||
Concentration Risk [Line Items] | ||
Number of customers | 5 | 5 |
Concentration risk (as a percent) | 62.00% | 65.00% |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Prepaid Expenses and Other Current Assets | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Restricted cash | $ 15 | $ 20 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Licensing revenues (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
License Agreement Terms | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Upfront payment received | $ 4,230 |
Basis of Presentation and Sum_7
Basis of Presentation and Summary of Significant Accounting Policies - Antidilutive Shares Excluded From Computation of Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of net loss per common share | 10,473,986 | 8,023,711 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of net loss per common share | 7,748,519 | 6,138,373 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securites excluded from computation of net loss per common share | 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 net loss per common share | 48,279 | 18,507 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,438 | $ 1,969 |
Work-in-process | 1,081 | 2,344 |
Finished goods | 1,885 | 2,819 |
Total inventory | $ 4,404 | $ 7,132 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,260 | $ 5,035 |
Less: accumulated depreciation | (1,999) | (1,151) |
Property and equipment, net | 3,261 | 3,884 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,108 | 833 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 363 | 389 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,114 | 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 | $ 66 | $ 481 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | |||||
Depreciation | $ 286 | $ 153 | $ 877 | $ 325 | |
Accumulated depreciation | 1,999 | 1,999 | $ 1,151 | ||
Inventory | |||||
Property, Plant and Equipment [Line Items] | |||||
Accumulated depreciation | 57 | 57 | |||
Prepaid expenses and other assets | |||||
Property, Plant and Equipment [Line Items] | |||||
Accumulated depreciation | $ 90 | $ 90 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2019 | Jan. 01, 2019 | |
Leases [Abstract] | |||
Operating lease assets | $ 2,411 | ||
Operating lease liabilities | $ 2,021 | $ 2,021 | $ 2,887 |
Option to renew, extension of lease term | 3 years | 3 years | |
Operating lease payments related to options to extend lease terms | $ 44 | ||
Operating lease costs | $ 494 | 1,563 | |
Cash paid for amounts included in the measurement of operating lease liabilities | $ 1,135 |
Leases - Operating Lease Assets
Leases - Operating Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
Non-current operating lease assets | $ 1,852 | ||
Current operating lease liabilities | 1,390 | $ 0 | |
Non-current operating lease liabilities | 631 | ||
Total operating lease liabilities | $ 2,021 | $ 2,887 |
Leases - Weighted Average Remai
Leases - Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Details) | Sep. 30, 2019 |
Leases [Abstract] | |
Weighted average remaining lease term (years) | 1 year 5 months |
Weighted average discount rate | 6.40% |
Leases - Operating Lease Maturi
Leases - Operating Lease Maturities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 |
Operating leases | ||
2019 | $ 452 | |
2020 | 1,191 | |
2021 | 401 | |
Thereafter | 0 | |
Total undiscounted future minimum lease payments | 2,044 | |
Less: difference between undiscounted lease payments and discounted operating lease liabilities | 23 | |
Total operating lease liabilities | $ 2,021 | $ 2,887 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Accrued expenses: | ||
Contract sales organization expenses | $ 0 | $ 4,482 |
Selling, general and administrative expenses | 5,881 | 4,812 |
Research and development expenses | 2,600 | 933 |
Payroll expenses | 6,601 | 4,199 |
Product revenue allowances | 6,963 | 2,856 |
Other | 1,415 | 1,139 |
Total accrued expenses | 23,460 | 18,421 |
Other current liabilities: | ||
Lease liability | 1,390 | 0 |
Total other current liabilities | 1,390 | 0 |
Total accrued expenses and other current liabilities | $ 24,850 | $ 18,421 |
License Agreements (Details)
License Agreements (Details) - USD ($) | Sep. 25, 2019 | Jan. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 |
AVP-825 License Agreement | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Aggregate cash payments received from license agreement | $ 70,000,000 | ||||||
Licensing revenue | $ 0 | $ 0 | $ 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 | 10.00% | ||||||
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 | Sep. 30, 2019USD ($)$ / shares | Sep. 12, 2019USD ($)installment$ / sharesshares | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)$ / shares | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) |
Debt Instrument [Line Items] | |||||||
Loss on extinguishment of debt | $ 7,155,000 | $ 0 | $ 7,155,000 | $ 0 | |||
Senior Notes | Note Purchase Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Debt maximum borrowing capacity | $ 150,000,000 | $ 150,000,000 | |||||
Debt face amount | 80,000,000 | 80,000,000 | 80,000,000 | 80,000,000 | $ 75,000,000 | ||
Debt amount to be issued | $ 70,000,000 | $ 70,000,000 | |||||
Stated interest rate | 10.75% | 10.75% | |||||
Debt principal payments, number of installments | installment | 8 | 8 | |||||
Debt upfront fee | $ 1,125,000 | $ 1,125,000 | |||||
Number of shares called by warrants | shares | 810,357 | 810,357 | |||||
Warrants exercise price (in USD per share) | $ / shares | $ 6.72 | $ 6.72 | |||||
Loans, term | 5 years | ||||||
Debt issuance costs | $ 4,836,000 | $ 4,836,000 | |||||
Fair value of warrants | $ 2,404,000 | ||||||
Debt issuance costs, additional as percentage of principal amount | 0.50% | 0.50% | |||||
Prepayment fee, after second and before third anniversary | 2.00% | 2.00% | |||||
Prepayment fee, after third and before fourth anniversary | 1.00% | 1.00% | |||||
Prepayment premium amount | $ 0 | $ 0 | |||||
Debt covenant, cash and cash equivalents | 30,000 | 30,000 | |||||
Interest expense | $ 2,372,000 | $ 2,361,000 | $ 7,148,000 | $ 6,855,000 | |||
Senior Notes | Note Purchase Agreement - First Delayed Draw Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt amount to be issued | 30,000,000 | 30,000,000 | |||||
Senior Notes | Note Purchase Agreement - First Delayed Draw Notes | Quarter Ended December 31, 2019 | |||||||
Debt Instrument [Line Items] | |||||||
Debt issuance criteria term, net sales and royalties benchmark | 9,000,000 | ||||||
Senior Notes | Note Purchase Agreement - Second Delayed Draw Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt amount to be issued | 20,000,000 | 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] | |||||||
Debt amount to be issued | 20,000,000 | 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 | 3,669,000 | |||||
Accrued and unpaid interest | $ 2,049,000 | ||||||
Exit fee (as a percent) | 2.00% | 2.00% | |||||
Loss on extinguishment of debt | $ 7,155,000 | ||||||
Warrants Expiring September 12, 2022 | |||||||
Debt Instrument [Line Items] | |||||||
Warrants exercise price (in USD per share) | $ / shares | $ 6.72 | $ 6.72 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) | Sep. 30, 2019 | Sep. 12, 2019 | Dec. 31, 2018 |
Short-term Debt [Line Items] | |||
Long-term debt, net | $ 74,266,000 | $ 72,500,000 | |
Note Purchase Agreement | Senior Notes | |||
Short-term Debt [Line Items] | |||
Face amount | 80,000,000 | $ 80,000,000 | 75,000,000 |
Front end fees | (1,082,000) | (872,000) | |
Debt issuance costs | (4,652,000) | (1,902,000) | |
Back end fees | 0 | 274,000 | |
Long-term debt, net | $ 74,266,000 | $ 72,500,000 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Defined Contribution Plan Disclosure [Line Items] | ||||
Defined contribution plan, cost | $ 151 | |||
Norway and UK employee plans | ||||
Defined Contribution Plan Disclosure [Line Items] | ||||
Defined contribution plan, cost | $ 4 | $ 6 | $ 15 | $ 75 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Thousands | Jun. 11, 2018USD ($)$ / sharesshares | Sep. 30, 2019vote$ / shares | Sep. 12, 2019$ / sharesshares |
Class of Stock [Line Items] | |||
Number of vote | vote | 1 | ||
Dividends declared (usd per share) | $ / shares | $ 0 | ||
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 | ||
Net proceeds received | $ | $ 59,917 | ||
Discounts and commissions | $ | 3,678 | ||
Offering expenses payable | $ | $ 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 | ||
Note Purchase Agreement | Senior Notes | |||
Class of Stock [Line Items] | |||
Number of shares called by warrants | 810,357 | ||
Warrants exercise price (in USD per share) | $ / shares | $ 6.72 |
Stockholders' Equity - Grant Da
Stockholders' Equity - Grant Date Fair Value of Warrants, Valuation Assumptions (Details) | Sep. 30, 2019$ / shares |
Risk free interest rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 0.0167 |
Expected term (in years) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 3 |
Expected volatility | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 0.6510 |
Annual dividend yield | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 0 |
Fair value of common stock | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants outstanding, measurement input | 6.72 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants Outstanding (Details) | Sep. 30, 2019$ / sharesshares |
Warrants Expiring November 1, 2020 | |
Class of Stock [Line Items] | |
Warrants outstanding (in shares) | shares | 1,866,831 |
Warrants exercise price (in USD per share) | $ / shares | $ 8.16 |
Warrants Expiring September 12, 2022 | |
Class of Stock [Line Items] | |
Warrants outstanding (in shares) | shares | 810,357 |
Warrants exercise price (in USD per share) | $ / shares | $ 6.72 |
Stock-based Compensation - Allo
Stock-based Compensation - Allocated Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 2,435 | $ 2,202 | $ 7,552 | $ 6,325 |
Cost of product sales | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 33 | 3 | 78 | 6 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 90 | 329 | 617 | 734 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 2,312 | $ 1,870 | $ 6,857 | $ 5,585 |
Stock-based Compensation - Narr
Stock-based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 66 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 2,435 | $ 2,202 | $ 7,552 | $ 6,325 | |
Plan options contractual life (up to) | 10 years | ||||
Award vesting period | 4 years | ||||
Unrecognized compensation cost | 21,214 | $ 21,214 | |||
Estimated weighted-average amortization period | 2 years 6 months 22 days | ||||
Service Based Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 4 years | 4 years | |||
Stock options to purchase shares (in shares) | 2,070,173 | 423,892 | |||
Weighted average grant date fair value (usd per share) | $ 4.78 | $ 20.35 | |||
Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted (in shares) | 20,600 | ||||
Restricted shares fair value at grant date (usd per share) | $ 10.20 | ||||
2017 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 91 | $ 84 | $ 319 | $ 363 | |
Shares issued (in shares) | 77,909 | 53,137 | 31,892 | ||
Inventory | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 62 | ||||
Prepaid expenses and other assets | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 29 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Option Activity (Details) - Service Based Stock Options - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Shares | |||
Beginning balance (in shares) | 6,182,873 | ||
Granted (in shares) | 2,070,173 | 423,892 | |
Exercised (in shares) | (151,039) | ||
Expired (in shares) | 0 | ||
Forfeited (in shares) | (353,488) | ||
Ending balance (in shares) | 7,748,519 | 6,182,873 | |
Exercisable (in shares) | 4,425,938 | ||
Vested and expected to vest (in shares) | 7,748,519 | ||
Weighted average exercise price per share | |||
Beginning balance (usd per share) | $ 10.60 | ||
Granted (usd per share) | 7.70 | ||
Exercised (usd per share) | 3.60 | ||
Expired (usd per share) | 0 | ||
Forfeited (usd per share) | 11.27 | ||
Ending balance (usd per share) | 9.93 | $ 10.60 | |
Exercisable (usd per share) | 9.49 | ||
Vested and expected to vest (usd per share) | $ 9.93 | ||
Weighted average remaining contractual life | |||
Options outstanding, Weighted average remaining contractual life | 6 years 7 months 19 days | 6 years 8 months 1 day | |
Options exercisable, Weighted average remaining contractual life | 4 years 11 months 14 days | ||
Vested and expected to vest, Weighted average remaining contractual life | 6 years 7 months 19 days |
Stock-based Compensation - Fair
Stock-based Compensation - Fair Value Options using Black-Scholed Pricing Model (Details) - Stock options - $ / shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 2.48% | 2.71% |
Expected term (in years) | 6 years 19 days | 5 years 11 months 5 days |
Expected volatility | 67.03% | 74.61% |
Annual dividend yield | 0.00% | 0.00% |
Fair value of common stock (usd per share) | $ 7.70 | $ 13.50 |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2019shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Balance at December 31, 2018 (in shares) | 0 |
Granted (in shares) | 20,600 |
Vested and settled (in shares) | 0 |
Expired/ forfeited/ canceled (in shares) | (20,600) |
Balance at June 30, 2019 (in shares) | 0 |
Expected to vest at June 30, 2019 (in shares) | 0 |