DEI Document
DEI Document - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 29, 2020 | Jun. 30, 2019 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | XERIS PHARMACEUTICALS INC | ||
Entity Central Index Key | 0001346302 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Voluntary Filers | No | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Trading Symbol | XERS | ||
Title of 12(b) Security | Common stock, $0.0001 par value per share | ||
Entity Interactive Data Current | Yes | ||
Entity Common Stock, Shares Outstanding | 37,570,080 | ||
Entity Listing, Par Value Per Share | $ 0.0001 | ||
Entity Public Float | $ 227.2 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets | ||
Cash and cash equivalents | $ 19,519 | $ 45,716 |
Short-term Investments | 56,030 | 66,917 |
Trade accounts receivable, net | 4,693 | 0 |
Other accounts receivable, net | 946 | 2,869 |
Inventory | 2,176 | 0 |
Prepaid expenses and other current assets | 4,119 | 2,397 |
Total current assets | 87,483 | 117,899 |
Investments | 13,231 | 0 |
Property and equipment, net | 7,853 | 2,034 |
Other assets | 420 | 95 |
Total assets | 108,987 | 120,028 |
Current Liabilities | ||
Accounts payable | 5,603 | 866 |
Other accrued liabilities | 18,119 | 8,214 |
Accrued trade discounts and rebates | 1,375 | 0 |
Accrued returns reserve | 1,957 | 0 |
Other current liabilities | 284 | 1,092 |
Total current liabilities | 27,338 | 10,172 |
Long-term debt, net of unamortized deferred costs | 58,305 | 31,890 |
Other liabilities | 8,908 | 2,560 |
Total liabilities | 94,551 | 44,622 |
Commitments and contingencies (Note 10) | ||
Stockholders' Equity | ||
Preferred stock, par value $0.0001 | 0 | 0 |
Common stock, par value $0.0001 | 3 | 2 |
Additional paid in capital | 260,635 | 196,121 |
Accumulated deficit | (246,245) | (120,665) |
Accumulated other comprehensive gain (loss) | 43 | (52) |
Total stockholders' equity | 14,436 | 75,406 |
Total liabilities and stockholders' equity | $ 108,987 | $ 120,028 |
Consolidated Balance Sheets Par
Consolidated Balance Sheets Parenthetical - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position Parenthetical [Abstract] | ||
Preferred Stock, Par Value Per Share | $ 0.0001 | $ 0.0001 |
Common Shares, Par Value Per Share | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Common Shares, Shares, Issued | 27,214,523 | 20,808,366 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Net sales | $ 1,627 | $ 0 |
Grant and other income | 1,095 | 2,423 |
Cost of goods sold | 1,603 | 0 |
Gross Profit | 1,119 | 2,423 |
Operating expenses | ||
Research and development | 60,438 | 40,654 |
Selling, general and administrative | 63,061 | 21,113 |
Total operating expenses | 123,499 | 61,767 |
Loss from operations | (122,380) | (59,344) |
Other income (expense) | ||
Interest and other income | 2,813 | 1,613 |
Interest expense | (7,163) | (2,545) |
Change in fair value of warrants | 692 | 196 |
Other income (expense) | (3,658) | (736) |
Net loss before benefit from income taxes | (126,038) | (60,080) |
Benefit from income taxes | 458 | 0 |
Net loss | (125,580) | (60,080) |
Other comprehensive gain (loss), net of tax | ||
Unrealized gains (losses) on investments | 93 | (52) |
Foreign currency translation adjustments | 2 | 0 |
Comprehensive gain (loss) | $ (125,485) | $ (60,132) |
Net loss per common share - basic and diluted | $ (4.81) | $ (4.99) |
Weighted average common shares outstanding - basic and diluted | 26,110,297 | 12,045,999 |
Statements of Convertible Prefe
Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Preferred Stock, Series A | Preferred Stock, Series B | Preferred Stock, Series C | Common Stock | Additional Paid-in Capital [Member] |
Preferred Stock, Shares Outstanding | 1,843,965 | 5,696,834 | 12,834,912 | |||
Preferred Stock, Value, Outstanding | $ 1,945 | $ 18,536 | $ 77,397 | |||
Common Stock, Shares, Outstanding | 2,159,068 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Common stock, par value $0.0001 | $ 1 | |||||
Additional paid in capital | $ 2,754 | |||||
Accumulated other comprehensive gain (loss) | $ 0 | |||||
Accumulated deficit | (60,585) | |||||
Stockholders' Equity Attributable to Parent | (57,830) | |||||
Net loss | (60,080) | |||||
Stock Issued During Period, Shares, New Issues | 707,680 | 6,555,000 | ||||
Stock Issued During Period, Value, New Issues | $ 4,414 | $ 0 | 88,903 | |||
Conversion of convertible preferred stock into common stock, shares | (1,843,965) | (5,696,834) | (13,542,592) | 11,837,073 | ||
Conversion of convertible preferred stock into common stock, value | 102,293 | $ (1,945) | $ (18,536) | $ (81,811) | $ 1 | 102,292 |
Exercise and vesting of stock-based awards | 248,978 | |||||
Adjustments to Additional Paid in Capital, Exercise and Vesting of Stock-Based Awards | $ 395 | 395 | ||||
Warrants, exercises in period | 8,247 | |||||
Warrants, exercises in period, value | $ 49 | 49 | ||||
Stock-based compensation | 1,728 | 1,728 | ||||
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | $ (52) | |||||
Preferred Stock, Shares Outstanding | 0 | 0 | 0 | |||
Preferred Stock, Value, Outstanding | $ 0 | $ 0 | $ 0 | |||
Common Stock, Shares, Outstanding | 20,808,366 | |||||
Preferred Stock, Shares Issued | 0 | |||||
Common stock, par value $0.0001 | $ 2 | $ 2 | ||||
Additional paid in capital | 196,121 | 196,121 | ||||
Accumulated other comprehensive gain (loss) | (52) | |||||
Accumulated deficit | (120,665) | |||||
Stockholders' Equity Attributable to Parent | 75,406 | |||||
Net loss | (125,580) | |||||
Stock Issued During Period, Shares, New Issues | 6,201,202 | |||||
Stock Issued During Period, Value, New Issues | $ 57,227 | $ 1 | 57,226 | |||
Exercise and vesting of stock-based awards | (128,307) | 128,307 | ||||
Adjustments to Additional Paid in Capital, Exercise and Vesting of Stock-Based Awards | $ 254 | 254 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 73,607 | |||||
Stock Issued During Period, Value, Employee Stock Purchase Plan | $ 532 | 532 | ||||
Warrants, exercises in period | 3,041 | |||||
Warrants, exercises in period, value | 18 | 18 | ||||
Stock-based compensation | 6,484 | 6,484 | ||||
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | $ 95 | |||||
Preferred Stock, Shares Outstanding | 0 | 0 | 0 | |||
Preferred Stock, Value, Outstanding | $ 0 | $ 0 | $ 0 | |||
Common Stock, Shares, Outstanding | 27,214,523 | |||||
Preferred Stock, Shares Issued | 0 | |||||
Common stock, par value $0.0001 | $ 3 | $ 3 | ||||
Additional paid in capital | 260,635 | $ 260,635 | ||||
Accumulated other comprehensive gain (loss) | 43 | |||||
Accumulated deficit | (246,245) | |||||
Stockholders' Equity Attributable to Parent | $ 14,436 |
Statement of Cash Flows
Statement of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (125,580,000) | $ (60,080,000) |
Income (Loss) Attributable to Parent, before Tax | (126,038,000) | (60,080,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 1,078,000 | 320,000 |
Amortization of investments | (686,000) | (218,000) |
Amortization of debt issuance costs | 948,000 | 560,000 |
Stock-based compensation | 6,484,000 | 1,728,000 |
Loss on extinguishment of debt | 2,324,000 | 0 |
Change in fair value of warrants | (692,000) | (196,000) |
Changes in operating assets and liabilities | ||
Trade accounts receivable | (4,693,000) | 0 |
Other accounts receivable | 1,634,000 | (1,670,000) |
Prepaid expenses and other current assets | (960,000) | (1,588,000) |
Inventory | (2,176,000) | 0 |
Other assets | (247,000) | 62,000 |
Accounts payable | 4,737,000 | (1,110,000) |
Other accrued liabilities | 8,912,000 | 5,630,000 |
Accrued trade discounts and rebates | 1,375,000 | 0 |
Accrued returns reserve | 1,957,000 | 0 |
Other liabilities | 1,239,000 | 283,000 |
Net cash used in operating activities | (104,346,000) | (56,279,000) |
Cash flows from investing activities | ||
Capital expenditures | (1,107,000) | (1,510,000) |
Purchases of investments | (102,472,000) | (68,851,000) |
Sales and maturities of investments | 101,196,000 | 2,100,000 |
Net cash used in investing activities | (2,383,000) | (68,261,000) |
Cash flows from financing activities | ||
Proceeds from Initial Public Offering | 0 | 98,325,000 |
Payments for Initial Public Offering Costs | 0 | (9,422,000) |
Proceeds from public offerings | 61,692,000 | 0 |
Payments of public offering costs | (4,465,000) | 0 |
Proceeds from sale of Series C Preferred Stock | 0 | 4,438,000 |
Payments for preferred stock issuance costs | 0 | (24,000) |
Proceeds from issuance of debt | 60,000,000 | 35,000,000 |
Repayment of debt | (35,000,000) | 0 |
Payments of debt issuance costs | (2,381,000) | (333,000) |
Proceeds from employee stock purchase plan | 532,000 | 0 |
Proceeds from exercise of stock awards | 152,000 | 227,000 |
Net cash provided by financing activities | 80,530,000 | 128,211,000 |
Effect of exchange rate on cash and cash equivalents | 2,000 | 0 |
Increase (decrease) in cash and cash equivalents | (26,197,000) | 3,671,000 |
Cash and cash equivalents, beginning of period | 45,716,000 | 42,045,000 |
Cash and cash equivalents, end of period | 19,519,000 | 45,716,000 |
Supplemental schedule of cash flow information | ||
Cash paid for interest | 3,717,000 | 1,711,000 |
Supplemental schedule of non-cash investing and financing activities | ||
Tenant improvement allowance | 5,658,000 | 0 |
Accrued debt issuance costs | 1,800,000 | 2,325,000 |
Allocation of debt proceeds to warrants | $ 0 | $ 1,012,000 |
Organization and Nature of the
Organization and Nature of the Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Nature of the Business | Organization and Nature of the Business Nature of business Xeris Pharmaceuticals, Inc. ("Xeris" or the "Company") is a specialty pharmaceutical company that was incorporated in Delaware in 2005. Xeris is dedicated to the development of ready-to-use injectable and infusible drug formulations that address important unmet medical needs, are easier to use by patients, caregivers and health practitioners, and reduce costs for payors and the healthcare system. Since our inception in 2005, the Company has devoted substantially all of our resources to research and development initiatives, undertaking preclinical studies of our product candidates, conducting clinical trials of our most advanced product candidates, organizing and staffing our company, raising capital and initiating the commercialization of our first product, Gvoke, which was approved by the FDA on September 10, 2019. Gvoke delivers ready-to-use glucagon via a commercially available pre-filled syringe or auto-injector for the treatment of severe hypoglycemia, a potentially life-threatening condition. The Company commercially launched Gvoke pre-filled syringe ("Gvoke PFS") in November 2019. The Company has financed its operations through the issuance of its common stock, convertible preferred stock and other equity instruments, debt financing and grant funding from the National Institutes of Health ("NIH") and other philanthropic organizations. The Company has generated $1.6 million in revenue from product sales as of December 31, 2019 . The Company has incurred operating losses since inception and has an accumulated deficit of $246.2 million as of December 31, 2019 . The Company expects to continue to incur net losses for at least the next 12 months. Based on the Company’s current operating plans and existing working capital at December 31, 2019 , in addition to the funds raised in its February 2020 equity offering, the Company believes cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next 12 months. The Company is subject to a number of risks similar to other specialty pharmaceutical companies, including, but not limited to, successful development and commercialization of its drug candidates, the development of new technological innovations by its competitors, protection of intellectual property and market acceptance of the Company’s products. Basis of presentation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). In the opinion of management, the accompanying consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the Company’s financial position and its results of operations and cash flows for the periods presented. The results of operations for such periods are not necessarily indicative of the results that may be expected for any future period. 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”) issued by the Financial Accounting Standards Board (“FASB”). Basis of Consolidation These consolidated financial statements include the financial statements of Xeris Pharmaceuticals, Inc. and its subsidiary, Xeris Pharmaceuticals Australia Pty Ltd. All intercompany transactions have been eliminated. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies The accompanying financial statements have been prepared in conformity with GAAP. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the ASC and ASUs of the FASB. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses included in the financial statements and accompanying notes. Actual results could differ from those estimates. Revenue recognition The Company applies the guidance in ASC 606 to all contracts with customers within the scope of the standard. The Company sells its products primarily to pharmaceutical wholesalers. These wholesalers then resell the Company’s products to their retail customers, such as pharmacies and mass merchandisers. In addition, the Company enters into arrangements with payors, group purchasing organizations, and health care providers that provide for government-mandated or privately-negotiated discounts and allowances related to the Company’s products. Revenue is recognized when the Company's customer (e.g., a wholesaler) obtains control of promised goods or services, based on the consideration the Company expects to receive in exchange for those goods or services. The estimated net sales price is generally based upon a list or fixed price less estimates of variable consideration (e.g., patient co-pay assistance, prompt payment discounts, payor rebates, chargebacks, service fees and product returns). The estimates of variable consideration are subject to a constraint such that some or all of the estimated amount of variable consideration will only be included in the transaction price to the extent that it is probable that a significant reversal of revenue will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment and other market data. Net sales represent gross product sales less estimated allowances for patient co-pay assistance programs, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns, all of which are recorded at the time of sale to pharmaceutical wholesalers. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future. Patient Co-Pay Assistance Program The Company offers a savings program to commercially insured patients under which the cost of a prescription to a patient is discounted. The Company reimburses pharmacies for this discount through a third-party vendor. The Company records an accrual to reduce gross sales for the estimated co-pay on units sold to distributors. The estimate is based on estimated percentages of products that will be prescribed to qualified patients, expected patient utilization of the discount program, average assistance paid based on reporting from the third-party vendor as well as industry data and levels of inventory in the distribution channel. Accrued co-pay fees are recorded as a reduction of revenue and included in accrued trade discounts and rebates on the consolidated balance sheets. Prompt Payment Discounts As an incentive for prompt payment, the Company offers a discount to most customers. The Company expects that all eligible customers will comply with the contractual terms to earn the discount. and, therefore, accrues the discount on all eligible sales. The Company records the discount as an allowance against trade accounts receivable on the consolidated balance sheets and as a reduction of revenue. Commercial Rebates The Company contracts with certain commercial entities to provide rebates. The Company accrues estimated rebates based on contract rates, estimated percentages of products that will be prescribed to qualified patients and estimated levels of inventory in the distribution channel and records the rebate as a reduction of revenue. Accrued commercial rebates are included in accrued trade discounts and rebates on the consolidated balance sheets. Government Rebates and Discounts The Company participates in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Coverage Gap Discount Program. The Company accrues estimated rebates and discounts based on estimated percentages of product sold to qualified patients, estimated rebate or discount percentages and estimated levels of inventory in the distribution channel that will be prescribed to qualified patients and records the rebates or discounts as a reduction of revenue. Accrued government rebates and discounts are included in accrued trade discounts and rebates on the consolidated balance sheets. Chargebacks The Company's products are subject to certain programs whereby pricing on products is discounted below wholesaler list price to participating commercial or government entities. These entities purchase products through wholesalers at the discounted price, and the wholesalers charge the difference between their acquisition cost and the discounted price back to the Company. The Company accrues estimated chargebacks based on contract prices, sales data obtained from third-party information and estimated levels of inventory in the distribution channel and records the chargebacks as a reduction of revenue. Accrued chargebacks are included in accrued trade discounts and rebates on the consolidated balance sheets. Service Fees The Company records service fees paid to its customers for distribution and inventory management services as a reduction to revenue. The Company accrues estimated service fees based on contractually determined amounts. Accrued service fees are included in accrued trade discounts and rebates on the consolidated balance sheets. Product Returns Consistent with industry practice, the Company maintains a return goods policy that allows customers to return product due to order or shipment errors, overstock, dating, recall or other changes in regulatory guidelines. Generally, product may be returned for a period beginning six months prior to its expiration date and up to one year after its expiration date. To determine the estimate of the provision for returns, the Company analyzes branded product return history of comparable products and other market data. In a reporting period, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. At December 31, 2019, the Company increased its returns reserve above the level indicated by the return history of comparable products due to factors related to the initial stocking of inventory for the launch of our new product. The Company records estimated sales returns in accrued returns reserve on the consolidated balance sheets and as a reduction of revenue. Bad debt expense The Company’s products are primarily sold to wholesalers. The Company monitors its accounts receivable balances to determine the impact, if any, of such factors as changes in customer concentration, credit risk and the realizability of its accounts receivable, and records a bad debt reserve when applicable. Concentration of credit risk For the year ended December 31, 2019, three customers accounted for 94% of the Company’s gross sales. These same three customers accounted for 97% of the trade accounts receivable at December 31, 2019. Cost of Goods Sold Cost of goods sold includes primarily product costs, which include all costs directly related to the purchase of raw materials, charges from our contract manufacturing organizations, and manufacturing overhead costs, as well as shipping and distribution charges. Cost of goods sold also includes losses on excess, slow-moving or obsolete inventory and inventory purchase commitments, if any. Manufacturing costs for Gvoke incurred prior to approval and commercialization were expensed as research and development expenses. Segment reporting Operating segments are identified as components of an enterprise for which separate discrete financial information is available and utilized by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company operates in one segment and, other than conducting certain clinical trials outside the United States, all of the Company’s operations are in the United States. Cash and cash equivalents The Company considers all demand deposits with financial institutions and highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Inventories Inventories are stated at the lower of cost or net realizable value, using the first-in, first-out convention. Inventories consist of raw materials, work in process and finished goods. The Company has entered into manufacturing and supply agreements for the manufacture or purchase of raw materials and production supplies. The Company’s inventories include the direct purchase cost of materials and supplies, charges from our contract manufacturing organizations and manufacturing overhead costs. The Company reviews its inventory balance quarterly to assess if it has obsolete or excess inventory and records a charge to cost of goods sold if and when applicable. Manufacturing costs for Gvoke prior to approval and commercialization were expensed as research and development expenses. Prepaid expenses and other current assets Prepaid expenses and other current assets include prepaid expenses for general business purposes, which are stated at cost and amortized on a straight-line basis over the related period of benefit. Prepaid expenses also include supplies and materials used in several research projects. These supplies and materials are expensed as they are consumed. Investments The Company classifies its investments in debt securities as available-for-sale investments. Investments classified as short-term on the balance sheets have original maturities of greater than 90 days but less than one year. Investments in available-for-sale securities are reported at estimated fair value. Available-for-sale securities consist primarily of agency securities, corporate securities, U.S. government securities and commercial paper. Unrealized gains and losses related to changes in the fair value of debt securities are recognized in accumulated other comprehensive loss on the Company's balance sheets. Changes in the fair value of available-for-sale securities impact the statements of operations and comprehensive loss only when such securities are sold or an other-than-temporary impairment is recognized. Realized gains and losses on the sale of securities are determined by specific identification of each security’s cost basis. The Company regularly reviews its investment portfolio to determine if any security is other-than-temporarily impaired, which would require an impairment charge to be recorded in the period any such determination is made. The Company considers factors such as the duration, severity of and reason for the decline in value, the financial condition of the issuer and any changes thereto, the potential recovery period and intent to sell. Fair value of financial instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a non-recurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, and accounts payable, are shown at cost, which approximates fair value due to the short-term nature of these instruments. The debt outstanding under the Amended and Restated Loan and Security Agreement (the "Amended Loan Agreement") approximates fair value due to the variable interest rate on the debt. Items measured at fair value on a recurring basis include the Company’s investments and warrants. Property and equipment Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the respective assets: Lab equipment 5 years Computer equipment 3 years Leasehold improvements Lesser of useful life or lease term Software 3-5 years Furniture and fixtures 5 years Office equipment 5 years Impairment of long-lived assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment . Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company recognized no material impairment charges for the years ended December 31, 2019 and 2018, respectively. Equity financing costs The Company capitalizes costs directly associated with equity financings until such financings are consummated, at which time such costs are recorded in additional paid in capital against the gross proceeds of the equity financings. The Company recognized $4.5 million of direct costs associated with the public equity offerings in additional paid in capital for the year ended December 31, 2019 and $9.4 million of direct costs associated with the IPO in additional paid in capital for the year ended December 31, 2018. Costs associated with the shelf registration statement on Form S-3, filed with the U.S. Securities and Exchange Commission's ("SEC") on August 6, 2019 and declared effective on August 21, 2019, have been capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company completes offerings under the shelf registration. At the end of the three-year life of the shelf registration, the remaining deferred offering costs, if any, will be charged to the results of operations. As of December 31, 2019 and 2018, $0.4 million and $0 , respectively, of deferred costs related to equity financings are included in other assets on the balance sheets. Deferred rent Certain of the Company’s lease agreements provide for scheduled rent increases during the lease term and also for abatement of some or all rental payments for a period of time after the occupancy date. In addition, certain of the Company’s lease agreements provided for tenant improvement allowances whereby the landlord funded the cost to build out the space. The Company recorded a liability for such lease incentives which is being amortized to rent expense such that rent expense is recognized on a straight-line basis throughout the lease term. Debt issuance costs Debt issuance costs incurred in connection with financing arrangements are amortized to interest expense over the life of the respective financing arrangement using the effective interest method. Debt issuance costs, net of related amortization, are deducted from the carrying value of the related debt. Warrants The Company’s warrants are classified as liabilities as they represent a financial instrument for a share of common stock. The warrants are revalued each reporting period with the change in fair value recorded in the accompanying statements of operations until the warrants are exercised, expire, or otherwise settled. Research and development expenses Research and development expenses are expensed as incurred. Research and development expenses include salaries, stock compensation and other personnel-related costs, consulting fees, fees paid for contract research and development services including those for preclinical and clinical trials, laboratory equipment and facilities costs, and other external costs. In addition, manufacturing costs of products prior to approval and commercial salability are expensed as research and development costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are received, the services are performed or the arrangement is terminated. Stock-based compensation expense The Company accounts for our stock-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation , or ASC 718. ASC 718 requires all stock-based payments, including stock options, restricted stock units and employee stock purchases, to be recognized in the statements of operations based on their grant date fair values. The Company estimates the grant date fair value of each option award using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, the risk-free interest rate and the expected dividend yield of the common stock. Restricted stock units are valued based on the fair market value of the Company’s common stock on the date they were granted. The Company recognizes stock-based compensation expense equal to the grant date fair value of stock options, restricted stock units and employee stock purchases on a straight-line basis over the requisite service period. Income taxes Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company policy is to include interest and penalties related to uncertain tax positions, if any, within the provision for taxes in the statements of operations and comprehensive loss. For the years ended December 31, 2019 and 2018, the Company did not accrue any interest or penalties on uncertain tax positions. Grant income The Company has received several grants from the NIH and other philanthropic organizations for certain research and development projects the Company has and is currently performing. Grant income is recognized when these research and development activities are performed and the Company has met criteria for reimbursement per the grant agreements. The Company has also received grants that were funded upfront. The Company defers the recognition of these awards until the related research and development expenses are incurred. Foreign currency translation Our functional currency is the United States Dollar. Monetary assets and liabilities of our non-US subsidiary are remeasured using the exchange rate in effect at the end of the period. Costs in local currency are remeasured using the average exchange rate for the period. The resulting remeasurement gains and losses are included in other comprehensive gain (loss). Comprehensive loss Comprehensive loss is defined as the change in equity during a period from transactions and other events, excluding changes resulting from investments from owners and distributions to owners. Comprehensive loss includes net loss, unrealized (gains) losses on debt securities classified as available-for-sale investments and foreign currency translation adjustments. Reclassifications In the fourth quarter of 2019, in conjunction with the recognition of product sales and related cost of sales, the Company reclassified grant income, service revenue and the related cost of revenue to other income (expense) on the Company's consolidated statements of operations and comprehensive loss. There was no impact to net loss. Prior periods have been revised to conform to the current year presentation. New accounting pronouncements Recently issued accounting pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases will be classified as either operating or finance leases under the new guidance. Operating leases will result in straight-line expense in the income statement, similar to current operating leases, and finance leases will result in more expense being recognized in the earlier years of the lease term, similar to current capital leases. The FASB has recently extended the effective date of this standard for certain companies. This standard will be effective for the Company for fiscal years beginning after December 15, 2020 and interim periods within fiscal years beginning after December 15, 2021. The Company is currently evaluating the impact the adoption of this new standard will have on the financial statements and related disclosures; however, since the Company is a lessee to certain leases for property whose terms exceed twelve months, it expects, once adopted, to report assets and liabilities related to these leases on its balance sheet. |
Inventory (Notes)
Inventory (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory [Line Items] | |
Inventory Disclosure [Text Block] | Inventory The components of inventories consisted of the following (in thousands): December 31, 2019 December 31, 2018 Raw materials $ 1,321 $ — Work in process 662 — Finished goods 193 — Inventory $ 2,176 $ — |
Property and Equipment (Notes)
Property and Equipment (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment [Abstract] | |
Property, Plant and Equipment | Property and Equipment Property and equipment consisted of the following: (in thousands) December 31, 2019 December 31, 2018 Lab equipment $ 2,528 $ 1,658 Furniture and fixtures 1,611 541 Computer equipment 232 87 Office equipment 80 109 Software 347 110 Leasehold improvements 4,543 180 9,341 2,685 Less: accumulated depreciation and amortization (1,488 ) (651 ) Property and equipment, net $ 7,853 $ 2,034 Depreciation and amortization expense relating to property and equipment was $1.1 million and $0.3 million for the years ended December 31, 2019 and 2018 , respectively. |
Other Accrued Liabilities (Note
Other Accrued Liabilities (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses [Abstract] | |
Other Accrued Liabilities | Other Accrued Liabilities Other accrued liabilities consisted of the following: (in thousands) December 31, 2019 December 31, 2018 Accrued research and development costs $ 7,062 $ 2,221 Accrued employee costs 6,818 4,326 Accrued marketing and selling costs 1,973 — Accrued interest expense 449 274 Accrued other costs 1,817 1,393 Other accrued liabilities $ 18,119 $ 8,214 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2019 | |
Long-term Debt, Unclassified [Abstract] | |
Long-Term Debt | Long-term Debt Senior Secured Loan Facility In February 2018, the Company entered into the Loan and Security Agreement, dated as of February 28, 2018 (as amended, the “Loan Agreement”), with Oxford Finance LLC, as the collateral agent and a lender (“Oxford”), and Silicon Valley Bank, as a lender (“SVB”, and together with Oxford, the “Lenders”) which provided for a senior secured loan facility of up to an aggregate principal amount of $45.0 million . The first tranche was $20.0 million and was drawn down in February 2018 (the "2018 Term A Loan"). The second tranche was $15.0 million and was drawn down in September 2018 (the "2018 Term B Loan"). The interest rate under the Loan Agreement was the thirty-day U.S. LIBOR rate plus 6.75% , which was 8.84% as of September 13, 2019, the date of repayment of the amounts outstanding under the Loan Agreement. Payments on the Loan Agreement were interest only for the first 24 months . The Company also issued warrants to the Lenders to purchase common stock, which is further discussed in Note 9, "Warrants." On September 10, 2019, the Company entered into an Amended Loan Agreement with the Lenders which amended and restated the Loan Agreement. Under the Amended Loan Agreement, the Lenders will extend up to $85.0 million in term loans to the Company in three tranches. The initial tranche of $60.0 million (the “Term A Loan”) was drawn down on September 13, 2019. The second tranche of $15.0 million (the “Term B Loan”) and the third tranche of $10.0 million (the “Term C Loan”) will become available to the Company upon the achievement of certain revenue targets prior to March 31, 2021 and June 30, 2021, respectively. The 2018 Term A Loan and 2018 Term B Loan and the related final payment fee of $2.3 million were repaid in conjunction with the execution of the Amended Loan Agreement. The Amended Loan Agreement provides for interest-only payments through March 31, 2021, after which the principal will be payable in 27 equal monthly installments. However, if the Term B Loan is funded, then the period for interest-only payments is extended through December 31, 2021, after which the principal will be payable in 30 equal monthly installments. If the Term C Loan is funded, then the period for interest-only payments is further extended through September 30, 2022, after which the principal will be payable in 21 equal monthly installments. The maturity date is June 1, 2023, provided that if the Term B Loan is funded, then the maturity date will be extended to June 1, 2024. After repayment, no loans may be reborrowed. For the period from the funding date of the Term A Loan through and including December 31, 2019, the loans incurred interest at a rate of 8.68% . Following such time, the loans shall incur interest at a floating per annum rate in an amount equal to the sum of 6.25% plus the greater of (a) 2.43% and (b) the thirty-day U.S. Dollar LIBOR rate. The Company incurred total debt issuance costs of $1.9 million related to the Amended Loan Agreement, which are reflected as a direct reduction to the term loan balance and are being amortized into interest expense over the life of the loan using the effective interest method. Pursuant to the Amended Loan Agreement, the Company provided a first priority security interest in substantially all of the Company’s assets, including intellectual property, subject to certain limited exceptions. The Amended Loan Agreement allows the Company to voluntarily prepay the outstanding amounts thereunder, but not less than $2.0 million of the outstanding principal at any time. Prior to April 1, 2021, the Company is subject to a prepayment fee equal to 1.50% of the principal amount being prepaid. In the event the Company draws down the second or third tranche, the period subject to the 1.50% prepayment fee is extended to January 1, 2022 and October 1, 2022, respectively. A final payment fee of 3.0% multiplied by the original principal amount of each tranche drawn is due upon the earlier to occur of the maturity date of the Amended Loan Agreement, the acceleration of the Amended Loan Agreement or prepayment of such borrowings and is recorded in other liabilities on the consolidated balance sheets. The Amended Loan Agreement contains customary representations and warranties, events of default (including an event of default upon a material adverse change of the Company) and affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to incur additional indebtedness, grant liens, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case subject to certain exceptions. The components of debt are as follows: (in thousands) December 31, 2019 December 31, 2018 2018 Term A Loan $ — $ 20,000 2018 Term B Loan — 15,000 Term A Loan 60,000 — Principal amount of long-term debt 60,000 35,000 Less: Unamortized deferred costs (1,695 ) (3,110 ) Long-term debt $ 58,305 $ 31,890 The following table sets forth the Company’s future minimum principal payments (in thousands): 2019 $ 0 2020 0 2021 20,000 2022 26,700 2023 13,300 $ 60,000 For the year-to-date period ended December 31, 2019 , the Company recognized interest expense of $7.2 million , of which $0.9 million related to the amortization of debt issuance costs. Included in such interest expense is a loss on extinguishment of debt of $2.3 million relating to the write-off of the remaining balance of unamortized debt issuance costs associated with the Loan Agreement. For the year ended December 31, 2018 , the Company recognized interest expense of $2.5 million , of which $0.6 million was related to the amortization of debt issuance costs. |
Public Stock Offerings
Public Stock Offerings | 12 Months Ended |
Dec. 31, 2019 | |
Reverse Stock Split and Initial Public Offering [Abstract] | |
Reverse Stock Split and Initial Public Offering | Public Stock Offerings On June 25, 2018, the Company closed the Initial Public Offering ("IPO") of its common stock pursuant to a registration statement on Form S-1, as amended. The Company sold an aggregate of 6,555,000 shares of common stock under the registration statement at an IPO price of $15.00 per share, including 855,000 shares of common stock pursuant to the exercise of the underwriters’ option to purchase additional shares. Net proceeds from the IPO were $88.9 million after deducting underwriting discounts and commissions as well as other IPO expenses. Upon closing the IPO, all outstanding shares of the Company's Series A, B and C convertible preferred stock were converted into 11,837,073 shares of common stock. On February 19, 2019, the Company completed a public offering of its common stock pursuant to a registration statement on Form S-1, as amended. The Company sold an aggregate of 5,996,775 shares of common stock at a price of $10.00 per share, including 116,775 shares of common stock pursuant to the exercise of the underwriters' option to purchase additional shares. Net proceeds from the public offering were $55.5 million after deducting underwriting discounts and commissions, as well as other public offering expenses. On August 6, 2019, the Company filed a shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale by the Company of up to an aggregate of $250.0 million of its common stock, preferred stock, debt securities, warrants and/or units, (the "Shelf"). The Company simultaneously entered into a Sales Agreement with Jefferies LLC, as sales agent, to provide for the offering, issuance and sale by the Company of up to $50.0 million of its common stock from time to time in "at-the-market" offerings under the Shelf. The Shelf was declared effective by the SEC on August 21, 2019. In December 2019, the Company sold an aggregate of 204,427 shares of common stock under the Shelf for net proceeds of $1.7 million after deducting selling commissions as well as other public offering expenses. Warrants In 2014 the Company issued 19,931 warrants (the “2014 Warrants”) to certain investors. The 2014 Warrants allow each holder to purchase one share of common stock for $5.912 . There have been 18,512 2014 Warrants exercised, and 1,419 warrants remain outstanding as of December 31, 2019 . As part of the Loan Agreement discussed in Note 6, "Long-term Debt", the Lenders received warrants concurrent with the borrowing. The warrants represent a right for the lender to purchase shares of the Company’s common stock at an initial exercise price of $11.169 per share. The Company issued 53,720 warrants (the "2018 Term A Warrants") upon the drawdown of the 2018 Term A Loan in February 2018, and the Company issued 40,292 warrants (the "2018 Term B Warrants") upon the drawdown of the 2018 Term B Loan in September 2018. There have been no exercises of Term A Warrants or Term B Warrants, and as such all 53,720 warrants and 40,292 warrants were outstanding as of December 31, 2019 , respectively. Because the warrants are a freestanding instrument, indexed to the Company's stock, they do not meet the criteria for equity classification. Therefore, the warrants are classified as liabilities and subject to remeasurement at each reporting period until they are exercised, expired, or otherwise settled. The Company recognized a gain (loss) of $78,000 , $351,000 and $263,000 upon the change in fair value of the warrants during the year ended December 31, 2019 related to the 2014 Warrants, the Term A Warrants and the Term B Warrants, respectively. The Company recognized a gain (loss) of $(56,000) , $(108,000) and $360,000 upon the change in fair value of the warrants during the year ended December 31, 2018 related to the 2014 Warrants, the Term A Warrants and the Term B Warrants, respectively. As of December 31, 2019 , the following warrants were outstanding: Outstanding Warrants Exercise Price per Warrant Expiration Date 2014 Warrants 1,419 $5.912 August 2020 Term A Warrants 53,720 $11.169 February 2025 Term B Warrants 40,292 $11.169 September 2025 95,431 |
Convertible Preferred Stock
Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2019 | |
Convertible preferred stock [Abstract] | |
Convertible Preferred Stock | Convertible Preferred Stock In February 2018, the Company issued an additional 707,680 shares of Series C convertible preferred stock for net proceeds of $4.4 million . During the second quarter of 2018, a majority of the holders of the Company's convertible preferred stock elected to have their shares converted into common stock; therefore, all outstanding shares of preferred stock were converted into 11,837,073 shares of common stock at a conversion rate of 1: 1.78112 upon the closing of the Company's IPO on June 25, 2018. Prior to the conversion of the convertible preferred stock into common stock, the holders of the Company’s convertible preferred stock were entitled to receive non-cumulative dividends at the rate of 8% of the purchase price per annum in preference to any dividends to the holders of the common stock, payable as and if when declared by the Board of Directors. The holders of the convertible preferred stock also were entitled to participate pro rata in any dividends paid to the holders of the common stock on an as-converted basis. No dividends were declared by the Company’s Board of Directors. |
Warrants (Notes)
Warrants (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Warrants [Abstract] | |
Warrants | Public Stock Offerings On June 25, 2018, the Company closed the Initial Public Offering ("IPO") of its common stock pursuant to a registration statement on Form S-1, as amended. The Company sold an aggregate of 6,555,000 shares of common stock under the registration statement at an IPO price of $15.00 per share, including 855,000 shares of common stock pursuant to the exercise of the underwriters’ option to purchase additional shares. Net proceeds from the IPO were $88.9 million after deducting underwriting discounts and commissions as well as other IPO expenses. Upon closing the IPO, all outstanding shares of the Company's Series A, B and C convertible preferred stock were converted into 11,837,073 shares of common stock. On February 19, 2019, the Company completed a public offering of its common stock pursuant to a registration statement on Form S-1, as amended. The Company sold an aggregate of 5,996,775 shares of common stock at a price of $10.00 per share, including 116,775 shares of common stock pursuant to the exercise of the underwriters' option to purchase additional shares. Net proceeds from the public offering were $55.5 million after deducting underwriting discounts and commissions, as well as other public offering expenses. On August 6, 2019, the Company filed a shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale by the Company of up to an aggregate of $250.0 million of its common stock, preferred stock, debt securities, warrants and/or units, (the "Shelf"). The Company simultaneously entered into a Sales Agreement with Jefferies LLC, as sales agent, to provide for the offering, issuance and sale by the Company of up to $50.0 million of its common stock from time to time in "at-the-market" offerings under the Shelf. The Shelf was declared effective by the SEC on August 21, 2019. In December 2019, the Company sold an aggregate of 204,427 shares of common stock under the Shelf for net proceeds of $1.7 million after deducting selling commissions as well as other public offering expenses. Warrants In 2014 the Company issued 19,931 warrants (the “2014 Warrants”) to certain investors. The 2014 Warrants allow each holder to purchase one share of common stock for $5.912 . There have been 18,512 2014 Warrants exercised, and 1,419 warrants remain outstanding as of December 31, 2019 . As part of the Loan Agreement discussed in Note 6, "Long-term Debt", the Lenders received warrants concurrent with the borrowing. The warrants represent a right for the lender to purchase shares of the Company’s common stock at an initial exercise price of $11.169 per share. The Company issued 53,720 warrants (the "2018 Term A Warrants") upon the drawdown of the 2018 Term A Loan in February 2018, and the Company issued 40,292 warrants (the "2018 Term B Warrants") upon the drawdown of the 2018 Term B Loan in September 2018. There have been no exercises of Term A Warrants or Term B Warrants, and as such all 53,720 warrants and 40,292 warrants were outstanding as of December 31, 2019 , respectively. Because the warrants are a freestanding instrument, indexed to the Company's stock, they do not meet the criteria for equity classification. Therefore, the warrants are classified as liabilities and subject to remeasurement at each reporting period until they are exercised, expired, or otherwise settled. The Company recognized a gain (loss) of $78,000 , $351,000 and $263,000 upon the change in fair value of the warrants during the year ended December 31, 2019 related to the 2014 Warrants, the Term A Warrants and the Term B Warrants, respectively. The Company recognized a gain (loss) of $(56,000) , $(108,000) and $360,000 upon the change in fair value of the warrants during the year ended December 31, 2018 related to the 2014 Warrants, the Term A Warrants and the Term B Warrants, respectively. As of December 31, 2019 , the following warrants were outstanding: Outstanding Warrants Exercise Price per Warrant Expiration Date 2014 Warrants 1,419 $5.912 August 2020 Term A Warrants 53,720 $11.169 February 2025 Term B Warrants 40,292 $11.169 September 2025 95,431 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments The Company has non-cancellable operating leases for office space, which expire at various times through 2031. The non-cancellable office lease agreements provide for monthly lease payments, which increase during the term of each lease agreement. In the first quarter of 2018, the Company signed a lease for office space in Chicago, Illinois. In the fourth quarter of 2018, the Company signed an amendment to this lease to occupy new space and relocated to this new space in March 2019. Future minimum lease payments under operating leases at December 31, 2019 are as follows (in thousands): 2020 $ 1,575 2021 2,208 2022 2,263 2023 1,745 2024 1,278 Thereafter 8,476 Total minimum lease payments $ 17,545 Total rent expense under these operating leases was approximately $2.2 million and $1.3 million for the years ended December 31, 2019 and 2018 , respectively. As of December 31, 2019, we had unused letters of credit of $1,083,000 which were issued primarily to secure leases. Litigation From time to time, the Company may become involved in various legal actions arising in the ordinary course of business. As of December 31, 2019 management was not aware of any existing, pending or threatened legal actions that would have a material impact on the financial position or results of operations of the Company. |
Stock Compensation Plan (Notes)
Stock Compensation Plan (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock Compensation Plan | Stock Compensation Plan In 2011 the Company adopted the 2011 Stock Option Issuance Plan (the “2011 Plan”) and subsequently amended it to authorize the Board of Directors to issue up to 4,714,982 incentive stock option and non-qualified stock option awards. The 2018 Stock Option and Incentive Plan (the "2018 Plan") was adopted by the Board of Directors in April 2018 and approved by the Company's stockholders in June 2018 to award up to 1,822,000 shares of common stock. This plan became effective on the date immediately prior to the effectiveness of the Company's IPO registration statement. The 2018 Plan replaced the 2011 Plan as the Board of Directors determined not to make additional awards under the 2011 Plan following the closing of the IPO, which occurred in June 2018. The 2018 Plan allows the compensation committee to make equity-based and cash-based incentive awards to the Company's officers, employees, directors and other key persons (including consultants). The 2018 Plan provides that the number of shares reserved and available for issuance under the plan will automatically increase each January 1, beginning on January 1, 2019, by 4% of the outstanding number of shares of our common stock on the immediately preceding December 31, or such lesser number of shares as determined by the compensation committee. This number is subject to adjustment in the event of a stock split, stock dividend or other change in the Company's capitalization. On January 1, 2019, the number of shares of common stock available for issuance under the 2018 Plan was automatically increased by 835,728 shares. As of December 31, 2019 , there were approximately 809,000 shares of common stock available for future issuance under the 2018 plan. The 2018 Employee Stock Purchase Plan (the "ESPP") was adopted by the Board of Directors in April 2018 and approved by the Company's stockholders in June 2018 to issue up to 193,000 shares of common stock to participating employees. Through the ESPP, eligible employees may authorize payroll deductions of up to 15% of their compensation to purchase up to the number of shares of common stock determined by dividing $25,000 by the closing market price of Xeris common stock on the offering date. The purchase price per share at each purchase date is equal to 85% of the lower of (i) the closing market price per share of Xeris common stock on the employee’s offering date or (ii) the closing market price per share of Xeris common stock on the purchase date. Each offering period has a six-month duration and purchase interval with a purchase date of the last business day of June and December each year. This plan became effective on the date immediately prior to the effectiveness of the Company's IPO registration statement. The ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2019 and each January 1 thereafter through January 1, 2028, by the least of (i) 1% of the outstanding number of shares of our common stock on the immediately preceding December 31; (ii) 386,000 shares or (iii) such lesser number of shares as determined by the ESPP administrator. On January 1, 2019, the number of shares of common stock available for issuance under the ESPP increased by 208,932 shares. The number of shares reserved under the ESPP is subject to adjustment in the event of a stock split, stock dividend or other change in capitalization. The Company issued 73,607 shares at a weighted average price of $7.22 per share during the year ended December 31, 2019 . As of December 31, 2019 , there were approximately 328,000 shares available for issuance under the ESPP. The Equity Inducement Plan (the "Inducement Plan") was adopted by the Board of Directors in February 2019. The Inducement Plan was adopted without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Plan allows the Company to make stock option or restricted stock unit awards to prospective employees of the Company as an inducement to such individuals to commence employment with the Company. The Company intends to use this Inducement Plan to help it attract and retain prospective employees who are necessary to support the commercial launch of Gvoke and the expansion of the Company generally. The Company initially reserved 750,000 shares of common stock for the issuance of awards under the Inducement Plan. This number is subject to adjustment in the event of a stock split, stock dividend or other change in our capitalization. As of December 31, 2019, there were approximately 340,000 shares of common stock available for future issuance under the Inducement Plan. Stock options are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Stock option awards typically vest over either two , three or four years after the grant date and expire ten years from the grant date. The fair value of each option is estimated on the date of grant using a Black-Scholes option valuation model that uses the assumptions noted in the following table. The expected term of options represents the period of time that options granted are expected to be outstanding. The risk-free interest rate for periods during the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The expected stock price volatility assumption is based on the historical volatilities of a peer group of publicly traded companies as well as the historical volatility of the Company's common stock since the Company began trading subsequent to its IPO in June 2018 over the period corresponding to the expected life as of the grant date. The expected dividend yield is based on the expected annual dividend as a percentage of the market value of the Company’s ordinary shares as of the grant date. The Company uses historical data to estimate employee terminations within the valuation model. The fair value of stock options granted was estimated with the following weighted average assumptions: Years Ended December 31, 2019 2018 Expected term (years) 6.0 6.0 Risk-free interest rate 2.14 % 2.48 % Expected volatility 60.27 % 56.84 % Expected dividends — — Stock option activity under the 2011 Plan, 2018 Plan and Inducement Plan for the year ended December 31, 2019 was as follows: OPTIONS WEIGHTED AVERAGE EXERCISE PRICE WEIGHTED AVERAGE CONTRACTUAL LIFE (YEARS) Outstanding - January 1, 2019 3,130,700 $ 8.06 8.69 Granted 1,600,650 12.21 Exercised and vested (128,307) 1.99 Forfeited (172,655) 16.33 Expired (1,403) 19.77 Outstanding - December 31, 2019 4,428,985 $ 9.40 8.19 Exercisable - December 31, 2019 1,647,911 $ 6.07 7.31 Vested and expected to vest at December 31, 2019 4,202,205 $ 9.32 8.16 The weighted average fair value of awards granted during the year ended December 31, 2019 was $6.97 per share. The total intrinsic value of options exercised during the year ended December 31, 2019 was $1.0 million . The aggregate intrinsic value of awards vested and expected to vest as of December 31, 2019 was $7.8 million . At December 31, 2019 , there was a total of $14.1 million of unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 2.3 years . Restricted stock unit ("RSU") awards for the year ended December 31, 2019 were as follows: Units Unvested balance - January 1, 2019 0 Granted 125,000 Unvested balance - December 31, 2019 125,000 Restricted stock unit awards are measured based on the fair market value of the underlying stock on the date of grant and recognized as expense on a straight-line basis over the employee’s requisite service period (generally the vesting period). As of December 31, 2019 , there was $1.3 million of unrecognized stock-based compensation expense related to RSUs, which is expected to be recognized over the weighted-average remaining vesting period of 3.1 years . The fair value of the ESPP Plan shares was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: Year Ended December 31, 2019 Expected term (years) 0.5 Risk-free interest rate 1.85% Expected volatility 70.70% Expected dividends — The following table summarizes the reporting of total stock-based compensation expense resulting from stock options, restricted stock units and the employee stock purchase plan (in thousands): Years Ended December 31, 2019 2018 Research and development $ 1,168 $ 518 Selling, general and administrative 5,316 1,210 Total stock-based compensation expense $ 6,484 $ 1,728 |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurements Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are classified and disclosed in one of the following categories: Level 1: Measured using unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2: Measured using quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Measured based on prices or valuation models that require inputs that are both significant to the fair value measurement and less observable from objective sources (i.e., supported by little or no market activity). Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below takes into account the market for its financial assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis. The following tables present the Company’s fair value hierarchy for those assets and liabilities measured at fair value as of December 31, 2019 and 2018 (in thousands): Total as of December 31, 2019 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 19,519 $ 19,519 $ — $ — Investments: U.S. government securities 32,175 32,175 — — Corporate securities 22,164 — 22,164 — Commercial paper 14,922 — 14,922 — Total investments $ 69,261 $ 32,175 $ 37,086 $ — Liabilities Warrant liabilities $ 150 $ — $ — $ 150 Total as of December 31, 2018 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 45,716 $ 45,716 $ — $ — Investments: U.S. government securities 38,737 38,737 — — Corporate securities 15,066 — 15,066 — Agency securities 11,931 — 11,931 — Commercial paper 1,183 1,183 — — Total investments $ 66,917 $ 39,920 $ 26,997 $ — Liabilities Warrant liabilities $ 860 $ — $ — $ 860 The fair value of the Company’s warrant liabilities is based on a Black-Scholes valuation which considers the expected term of the warrants as well as the risk-free interest rate and expected volatility of the Company's stock. The Company has determined that the warrant liabilities' fair values are Level 3 items within the fair value hierarchy. The following table presents the changes in the warrant liabilities (in thousands): Balance at December 31, 2018 $ 860 Exercise of warrants (18 ) Change in fair value of warrants (692 ) Balance at December 31, 2019 $ 150 There were no transfers between any of the levels of the fair value hierarchy during the years ended December 31, 2019 and 2018 . |
Available-for-Sale Investments
Available-for-Sale Investments (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-term investments | Available-for-Sale Investments The Company classifies its investments in debt securities as available-for-sale. Debt securities are comprised of highly liquid investments with minimum “A” rated securities and, as of December 31, 2019 , consist of U.S. Treasury and agency bonds and corporate entity commercial paper and securities, all with maturities of more than three months but less than two years at the date of purchase. Debt securities as of December 31, 2019 had an average remaining maturity of 0.70 years . The debt securities are reported at fair value with unrealized gains or losses recorded in accumulated other comprehensive gain (loss) in the consolidated balance sheets. Refer to Note 12, "Fair Value Measurements," for information related to the fair value measurements and valuation methods utilized. The following table represents the Company’s available-for-sale investments by major security type as of December 31, 2019 and 2018 (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Fair Value Investments: Commercial paper $ 14,922 $ — $ — $ 14,922 Corporate securities 22,146 20 (2 ) 22,164 U.S. government securities 32,152 23 — 32,175 Total available-for-sale investments $ 69,220 $ 43 $ (2 ) $ 69,261 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Fair Value Investments: Agency securities $ 11,944 $ — $ (13 ) $ 11,931 Commercial paper 1,183 — — 1,183 Corporate securities 15,081 — (15 ) 15,066 U.S. government securities 38,761 — (24 ) 38,737 Total available-for-sale investments $ 66,969 $ — $ (52 ) $ 66,917 The Company reviews available-for-sale investments for other-than-temporary impairment loss periodically. The Company considers factors such as the duration, severity of and reason for the decline in value, the potential recovery period and our intent to sell. For debt securities, we also consider whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the years ended December 31, 2019 and 2018 , the Company did not recognize any other-than-temporary impairment losses. All marketable securities with unrealized losses have been in a loss position for less than twelve months. |
Net Loss Per Share (Notes)
Net Loss Per Share (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Earnings Per Share [Text Block] | Net Loss Per Common Share Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the outstanding shares of preferred stock, warrants, stock option awards and restricted stock units have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average common shares outstanding used to calculate both basic and diluted loss per common share are the same. The following potentially dilutive securities were excluded from the computation of diluted weighted average common shares outstanding due to their anti-dilutive effect: As of December 31, 2019 2018 Vested and unvested stock options 4,428,985 3,130,700 Restricted stock units 125,000 — Warrants 95,431 102,647 4,649,416 3,233,347 |
Defined Contribution Plan (Note
Defined Contribution Plan (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Postemployment Benefits [Abstract] | |
Compensation and Employee Benefit Plans | Defined Contribution Plan The Company sponsors an employee retirement plan qualifying under Section 401(k) of the Internal Revenue Code for all eligible employees in the United States. Employees become eligible to contribute to the plan upon meeting certain age requirements and 30 days of service. Commencing in 2019, the Company began discretionary matching employee contributions up to certain limits. For the year ended December 31, 2019, the Company made $0.4 million of matching contributions to the plan. |
Income Taxes (Notes)
Income Taxes (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure | Income Taxes A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate of 21% to the Company’s effective income tax rate is as follows: Years Ended December 31, (in thousands) 2019 2018 Federal tax benefit at statutory rate $ (26,468 ) $ (12,617 ) State tax benefit, net of federal benefit (5,570 ) (1,842 ) Research and development and orphan drug credits (2,912 ) (2,279 ) Uncertain tax positions 342 603 Permanent adjustments to expenses 169 45 Stock-based compensation 683 76 Return to provision adjustment (3,278 ) (2,470 ) Rate impact of deferred tax balance — (63 ) Statutory rate differential (51 ) — Other 339 9 Changes in valuation allowance 36,288 18,538 Total income tax benefit $ (458 ) $ — The benefit for income taxes for 2019 is attributable to an Australian research and development tax incentive that will be refunded to the Company after the 2019 income tax filing. During the years ended December 31, 2019 and 2018 , the Company had no interest and penalties related to income taxes. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A valuation allowance is required to be established or maintained when, based on currently available information, it is more likely than not that all or a portion of a deferred tax asset will not be realized. The guidance on accounting for income taxes provides important factors in determining whether a deferred tax asset will be realized, including whether there has been sufficient taxable income in recent years and whether sufficient income can reasonably be expected in future years in order to utilize the deferred tax asset. For the year ended December 31, 2019 , we have evaluated the need to maintain a valuation allowance for deferred tax assets based on our assessment of whether it is more likely than not that deferred tax benefits will be realized through the generation of future taxable income. Appropriate consideration is given to all available evidence, both positive and negative, in assessing the need for a valuation allowance. Significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, (in thousands) 2019 2018 Deferred tax assets: Net operating losses $ 55,110 $ 25,372 Federal research and orphan drug credits 8,309 5,426 Stock-based compensation 1,092 267 Other temporary differences 4,648 1,679 Valuation allowance (68,950 ) (32,662 ) Total assets 209 82 Deferred tax liabilities: Fixed and intangible assets (155 ) (82 ) Other deferred tax liabilities (54 ) — Total liabilities (209 ) (82 ) Net deferred tax assets $ — $ — As of December 31, 2019, the Company had federal net operating loss carryforwards of $215.3 million and various state net operating loss carryforwards of $147.5 million . As of December 31, 2018, the Company had federal net operating loss carryforwards of $108.8 million and various state net operating loss carryforwards of $35.6 million . Net operating loss carryforwards for U.S. federal income tax purposes that were generated prior to January 1, 2018 have a twenty-year carryforward life and the earliest layers will begin to expire in 2025. Under the Tax Act, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such net operating losses is limited to 80% of the current year’s taxable income. U.S. state net operating loss carryforwards will start to expire in 2029 for the earliest net operating loss layers to the extent there is not sufficient state taxable income to utilize those net operating loss carryforwards. At December 31, 2019, the Company had $8.3 million and $1.0 million of federal and state income tax credits, respectively, to reduce future tax liabilities. As of December 31, 2018, the Company had $5.8 million and $2.0 million of federal and state income tax credits, respectively, to reduce future tax liabilities. The federal income tax credits consist primarily of orphan drug credits and research and development credits. The U.S. state income tax credits consist primarily of California and Illinois research and development credits. Both the U.S. federal orphan drug credits and research and development credits have a twenty-year carryforward life. The U.S. federal orphan drug credits and the research and development credits will both begin to expire in 2025. A reconciliation of the beginning and ending amounts of valuation allowances for the years ended December 31, 2019 and 2018 is as follows (in thousands): Valuation allowance at December 31, 2017 $ (14,124 ) Increase for 2018 activity (18,538 ) Valuation allowance at December 31, 2018 (32,662 ) Increase for 2019 activity (36,288 ) Valuation allowance at December 31, 2019 $ (68,950 ) The Company is required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. The Company accounts for the uncertainty in income taxes by utilizing a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken, or are expected to be taken, on an income tax return. The changes in the Company's uncertain income tax positions for the years ended December 31, 2019 and 2018 , excluding interest and penalties, consisted of the following (in thousands): December 31, 2019 2018 Beginning balance - uncertain tax positions $ 603 $ — Increases related to tax positions taken during the current year 246 228 Increases related to tax positions taken during the prior year 96 375 Ending balance - uncertain tax positions $ 945 $ 603 For the year ended December 31, 2019 , the increase in uncertain tax positions was attributable primarily to the U.S. federal orphan drug credits and research and development credits. In the Company’s balance sheet, uncertain tax positions of $0.9 million were offset against deferred tax assets. The Company policy is to include interest and penalties related to uncertain tax penalties, if any, within the provision for taxes in the statements of operations. The Company did not accrue any interest or penalties for the years ended December 31, 2019 and 2018 . |
Subsequent Events (Notes)
Subsequent Events (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Event [Line Items] | |
Subsequent Events | Subsequent Event On February 14, 2020, the Company completed a public offering of its common stock pursuant to a shelf registration statement on Form S-3, which was filed on August 6, 2019 and declared effective by the SEC on August 21, 2019. The Company sold 10,299,769 shares of common stock at a price of $4.15 per share, including 1,299,769 shares of common stock pursuant to the partial exercise of the underwriters' option to purchase up to an additional 1,350,000 shares of common stock. Gross proceeds from the offering were $42.7 million . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Revenue Recognition, Sales of Goods [Policy Text Block] | Revenue recognition The Company applies the guidance in ASC 606 to all contracts with customers within the scope of the standard. The Company sells its products primarily to pharmaceutical wholesalers. These wholesalers then resell the Company’s products to their retail customers, such as pharmacies and mass merchandisers. In addition, the Company enters into arrangements with payors, group purchasing organizations, and health care providers that provide for government-mandated or privately-negotiated discounts and allowances related to the Company’s products. Revenue is recognized when the Company's customer (e.g., a wholesaler) obtains control of promised goods or services, based on the consideration the Company expects to receive in exchange for those goods or services. The estimated net sales price is generally based upon a list or fixed price less estimates of variable consideration (e.g., patient co-pay assistance, prompt payment discounts, payor rebates, chargebacks, service fees and product returns). The estimates of variable consideration are subject to a constraint such that some or all of the estimated amount of variable consideration will only be included in the transaction price to the extent that it is probable that a significant reversal of revenue will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment and other market data. Net sales represent gross product sales less estimated allowances for patient co-pay assistance programs, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns, all of which are recorded at the time of sale to pharmaceutical wholesalers. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future. Patient Co-Pay Assistance Program The Company offers a savings program to commercially insured patients under which the cost of a prescription to a patient is discounted. The Company reimburses pharmacies for this discount through a third-party vendor. The Company records an accrual to reduce gross sales for the estimated co-pay on units sold to distributors. The estimate is based on estimated percentages of products that will be prescribed to qualified patients, expected patient utilization of the discount program, average assistance paid based on reporting from the third-party vendor as well as industry data and levels of inventory in the distribution channel. Accrued co-pay fees are recorded as a reduction of revenue and included in accrued trade discounts and rebates on the consolidated balance sheets. Prompt Payment Discounts As an incentive for prompt payment, the Company offers a discount to most customers. The Company expects that all eligible customers will comply with the contractual terms to earn the discount. and, therefore, accrues the discount on all eligible sales. The Company records the discount as an allowance against trade accounts receivable on the consolidated balance sheets and as a reduction of revenue. Commercial Rebates The Company contracts with certain commercial entities to provide rebates. The Company accrues estimated rebates based on contract rates, estimated percentages of products that will be prescribed to qualified patients and estimated levels of inventory in the distribution channel and records the rebate as a reduction of revenue. Accrued commercial rebates are included in accrued trade discounts and rebates on the consolidated balance sheets. Government Rebates and Discounts The Company participates in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Coverage Gap Discount Program. The Company accrues estimated rebates and discounts based on estimated percentages of product sold to qualified patients, estimated rebate or discount percentages and estimated levels of inventory in the distribution channel that will be prescribed to qualified patients and records the rebates or discounts as a reduction of revenue. Accrued government rebates and discounts are included in accrued trade discounts and rebates on the consolidated balance sheets. Chargebacks The Company's products are subject to certain programs whereby pricing on products is discounted below wholesaler list price to participating commercial or government entities. These entities purchase products through wholesalers at the discounted price, and the wholesalers charge the difference between their acquisition cost and the discounted price back to the Company. The Company accrues estimated chargebacks based on contract prices, sales data obtained from third-party information and estimated levels of inventory in the distribution channel and records the chargebacks as a reduction of revenue. Accrued chargebacks are included in accrued trade discounts and rebates on the consolidated balance sheets. Service Fees The Company records service fees paid to its customers for distribution and inventory management services as a reduction to revenue. The Company accrues estimated service fees based on contractually determined amounts. Accrued service fees are included in accrued trade discounts and rebates on the consolidated balance sheets. Product Returns Consistent with industry practice, the Company maintains a return goods policy that allows customers to return product due to order or shipment errors, overstock, dating, recall or other changes in regulatory guidelines. Generally, product may be returned for a period beginning six months prior to its expiration date and up to one year after its expiration date. To determine the estimate of the provision for returns, the Company analyzes branded product return history of comparable products and other market data. In a reporting period, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. At December 31, 2019, the Company increased its returns reserve above the level indicated by the return history of comparable products due to factors related to the initial stocking of inventory for the launch of our new product. The Company records estimated sales returns in accrued returns reserve on the consolidated balance sheets and as a reduction of revenue. |
Receivables, Trade and Other Accounts Receivable, Allowance for Doubtful Accounts, Policy [Policy Text Block] | Bad debt expense The Company’s products are primarily sold to wholesalers. The Company monitors its accounts receivable balances to determine the impact, if any, of such factors as changes in customer concentration, credit risk and the realizability of its accounts receivable, and records a bad debt reserve when applicable. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of credit risk For the year ended December 31, 2019, three customers accounted for 94% of the Company’s gross sales. These same three customers accounted for 97% of the trade accounts receivable at December 31, 2019. |
Cost of Goods and Service [Policy Text Block] | Cost of Goods Sold Cost of goods sold includes primarily product costs, which include all costs directly related to the purchase of raw materials, charges from our contract manufacturing organizations, and manufacturing overhead costs, as well as shipping and distribution charges. Cost of goods sold also includes losses on excess, slow-moving or obsolete inventory and inventory purchase commitments, if any. Manufacturing costs for Gvoke incurred prior to approval and commercialization were expensed as research and development expenses. |
Segment Reporting, Policy [Policy Text Block] | Segment reporting Operating segments are identified as components of an enterprise for which separate discrete financial information is available and utilized by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company operates in one segment and, other than conducting certain clinical trials outside the United States, all of the Company’s operations are in the United States. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and cash equivalents The Company considers all demand deposits with financial institutions and highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. |
Inventory, Policy [Policy Text Block] | Inventories Inventories are stated at the lower of cost or net realizable value, using the first-in, first-out convention. Inventories consist of raw materials, work in process and finished goods. The Company has entered into manufacturing and supply agreements for the manufacture or purchase of raw materials and production supplies. The Company’s inventories include the direct purchase cost of materials and supplies, charges from our contract manufacturing organizations and manufacturing overhead costs. The Company reviews its inventory balance quarterly to assess if it has obsolete or excess inventory and records a charge to cost of goods sold if and when applicable. Manufacturing costs for Gvoke prior to approval and commercialization were expensed as research and development expenses. |
Investment, Policy [Policy Text Block] | Investments The Company classifies its investments in debt securities as available-for-sale investments. Investments classified as short-term on the balance sheets have original maturities of greater than 90 days but less than one year. Investments in available-for-sale securities are reported at estimated fair value. Available-for-sale securities consist primarily of agency securities, corporate securities, U.S. government securities and commercial paper. Unrealized gains and losses related to changes in the fair value of debt securities are recognized in accumulated other comprehensive loss on the Company's balance sheets. Changes in the fair value of available-for-sale securities impact the statements of operations and comprehensive loss only when such securities are sold or an other-than-temporary impairment is recognized. Realized gains and losses on the sale of securities are determined by specific identification of each security’s cost basis. The Company regularly reviews its investment portfolio to determine if any security is other-than-temporarily impaired, which would require an impairment charge to be recorded in the period any such determination is made. The Company considers factors such as the duration, severity of and reason for the decline in value, the financial condition of the issuer and any changes thereto, the potential recovery period and intent to sell. |
Fair Value Measurement, Policy [Policy Text Block] | Fair value of financial instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a non-recurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, and accounts payable, are shown at cost, which approximates fair value due to the short-term nature of these instruments. The debt outstanding under the Amended and Restated Loan and Security Agreement (the "Amended Loan Agreement") approximates fair value due to the variable interest rate on the debt. Items measured at fair value on a recurring basis include the Company’s investments and warrants. |
Property, Plant and Equipment, Policy | Property and equipment Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the respective assets: Lab equipment 5 years Computer equipment 3 years Leasehold improvements Lesser of useful life or lease term Software 3-5 years Furniture and fixtures 5 years Office equipment 5 years |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of long-lived assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment . Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company recognized no material impairment charges for the years ended December 31, 2019 and 2018, respectively. |
Research and Development Expense, Policy [Policy Text Block] | Research and development expenses Research and development expenses are expensed as incurred. Research and development expenses include salaries, stock compensation and other personnel-related costs, consulting fees, fees paid for contract research and development services including those for preclinical and clinical trials, laboratory equipment and facilities costs, and other external costs. In addition, manufacturing costs of products prior to approval and commercial salability are expensed as research and development costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are received, the services are performed or the arrangement is terminated. |
Share-based Payment Arrangement [Policy Text Block] | Stock-based compensation expense The Company accounts for our stock-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation , or ASC 718. ASC 718 requires all stock-based payments, including stock options, restricted stock units and employee stock purchases, to be recognized in the statements of operations based on their grant date fair values. The Company estimates the grant date fair value of each option award using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, the risk-free interest rate and the expected dividend yield of the common stock. Restricted stock units are valued based on the fair market value of the Company’s common stock on the date they were granted. The Company recognizes stock-based compensation expense equal to the grant date fair value of stock options, restricted stock units and employee stock purchases on a straight-line basis over the requisite service period. |
Income Tax, Policy [Policy Text Block] | Income taxes Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company policy is to include interest and penalties related to uncertain tax positions, if any, within the provision for taxes in the statements of operations and comprehensive loss. For the years ended December 31, 2019 and 2018, the Company did not accrue any interest or penalties on uncertain tax positions. |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign currency translation Our functional currency is the United States Dollar. Monetary assets and liabilities of our non-US subsidiary are remeasured using the exchange rate in effect at the end of the period. Costs in local currency are remeasured using the average exchange rate for the period. The resulting remeasurement gains and losses are included in other comprehensive gain (loss). |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive loss Comprehensive loss is defined as the change in equity during a period from transactions and other events, excluding changes resulting from investments from owners and distributions to owners. Comprehensive loss includes net loss, unrealized (gains) losses on debt securities classified as available-for-sale investments and foreign currency translation adjustments. |
Reclassification, Policy [Policy Text Block] | Reclassifications In the fourth quarter of 2019, in conjunction with the recognition of product sales and related cost of sales, the Company reclassified grant income, service revenue and the related cost of revenue to other income (expense) on the Company's consolidated statements of operations and comprehensive loss. There was no impact to net loss. Prior periods have been revised to conform to the current year presentation. |
New Accounting Pronouncements, Policy [Policy Text Block] | New accounting pronouncements Recently issued accounting pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases will be classified as either operating or finance leases under the new guidance. Operating leases will result in straight-line expense in the income statement, similar to current operating leases, and finance leases will result in more expense being recognized in the earlier years of the lease term, similar to current capital leases. The FASB has recently extended the effective date of this standard for certain companies. This standard will be effective for the Company for fiscal years beginning after December 15, 2020 and interim periods within fiscal years beginning after December 15, 2021. The Company is currently evaluating the impact the adoption of this new standard will have on the financial statements and related disclosures; however, since the Company is a lessee to certain leases for property whose terms exceed twelve months, it expects, once adopted, to report assets and liabilities related to these leases on its balance sheet. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |
Schedule of Property and Equipment Useful Lives [Table Text Block] | Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the respective assets: Lab equipment 5 years Computer equipment 3 years Leasehold improvements Lesser of useful life or lease term Software 3-5 years Furniture and fixtures 5 years Office equipment 5 years |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities were excluded from the computation of diluted weighted average common shares outstanding due to their anti-dilutive effect: As of December 31, 2019 2018 Vested and unvested stock options 4,428,985 3,130,700 Restricted stock units 125,000 — Warrants 95,431 102,647 4,649,416 3,233,347 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory [Line Items] | |
Schedule of Inventory | The components of inventories consisted of the following (in thousands): December 31, 2019 December 31, 2018 Raw materials $ 1,321 $ — Work in process 662 — Finished goods 193 — Inventory $ 2,176 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment [Abstract] | |
Property, Plant and Equipment | Property and equipment consisted of the following: (in thousands) December 31, 2019 December 31, 2018 Lab equipment $ 2,528 $ 1,658 Furniture and fixtures 1,611 541 Computer equipment 232 87 Office equipment 80 109 Software 347 110 Leasehold improvements 4,543 180 9,341 2,685 Less: accumulated depreciation and amortization (1,488 ) (651 ) Property and equipment, net $ 7,853 $ 2,034 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses [Abstract] | |
Other Accrued Liabilities | Other accrued liabilities consisted of the following: (in thousands) December 31, 2019 December 31, 2018 Accrued research and development costs $ 7,062 $ 2,221 Accrued employee costs 6,818 4,326 Accrued marketing and selling costs 1,973 — Accrued interest expense 449 274 Accrued other costs 1,817 1,393 Other accrued liabilities $ 18,119 $ 8,214 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Long-term Debt, Unclassified [Abstract] | |
Schedule of Long-term Debt Instruments | The components of debt are as follows: (in thousands) December 31, 2019 December 31, 2018 2018 Term A Loan $ — $ 20,000 2018 Term B Loan — 15,000 Term A Loan 60,000 — Principal amount of long-term debt 60,000 35,000 Less: Unamortized deferred costs (1,695 ) (3,110 ) Long-term debt $ 58,305 $ 31,890 |
Schedule of Maturities of Long-term Debt | The following table sets forth the Company’s future minimum principal payments (in thousands): 2019 $ 0 2020 0 2021 20,000 2022 26,700 2023 13,300 $ 60,000 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Warrants [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | As of December 31, 2019 , the following warrants were outstanding: Outstanding Warrants Exercise Price per Warrant Expiration Date 2014 Warrants 1,419 $5.912 August 2020 Term A Warrants 53,720 $11.169 February 2025 Term B Warrants 40,292 $11.169 September 2025 95,431 |
Commitments and Contingencies F
Commitments and Contingencies Future Minimum Lease Payments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum lease payments under operating leases at December 31, 2019 are as follows (in thousands): 2020 $ 1,575 2021 2,208 2022 2,263 2023 1,745 2024 1,278 Thereafter 8,476 Total minimum lease payments $ 17,545 |
Stock Compensation Plan (Tables
Stock Compensation Plan (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | Restricted stock unit ("RSU") awards for the year ended December 31, 2019 were as follows: Units Unvested balance - January 1, 2019 0 Granted 125,000 Unvested balance - December 31, 2019 125,000 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | The following table summarizes the reporting of total stock-based compensation expense resulting from stock options, restricted stock units and the employee stock purchase plan (in thousands): Years Ended December 31, 2019 2018 Research and development $ 1,168 $ 518 Selling, general and administrative 5,316 1,210 Total stock-based compensation expense $ 6,484 $ 1,728 |
Share-based Payment Arrangement, Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock-based Compensation Assumptions Used in Black-Scholes Option Valuation Model | The fair value of stock options granted was estimated with the following weighted average assumptions: Years Ended December 31, 2019 2018 Expected term (years) 6.0 6.0 Risk-free interest rate 2.14 % 2.48 % Expected volatility 60.27 % 56.84 % Expected dividends — — |
Share-based Compensation, Activity | Stock option activity under the 2011 Plan, 2018 Plan and Inducement Plan for the year ended December 31, 2019 was as follows: OPTIONS WEIGHTED AVERAGE EXERCISE PRICE WEIGHTED AVERAGE CONTRACTUAL LIFE (YEARS) Outstanding - January 1, 2019 3,130,700 $ 8.06 8.69 Granted 1,600,650 12.21 Exercised and vested (128,307) 1.99 Forfeited (172,655) 16.33 Expired (1,403) 19.77 Outstanding - December 31, 2019 4,428,985 $ 9.40 8.19 Exercisable - December 31, 2019 1,647,911 $ 6.07 7.31 Vested and expected to vest at December 31, 2019 4,202,205 $ 9.32 8.16 The weighted average fair value of awards granted during the year ended December 31, 2019 was $6.97 per share. The total intrinsic value of options exercised during the year ended December 31, 2019 was $1.0 million . The aggregate intrinsic value of awards vested and expected to vest as of December 31, 2019 was $7.8 million . |
Restricted stock units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The fair value of the ESPP Plan shares was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: Year Ended December 31, 2019 Expected term (years) 0.5 Risk-free interest rate 1.85% Expected volatility 70.70% Expected dividends — |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements, Recurring and Nonrecurring | The following tables present the Company’s fair value hierarchy for those assets and liabilities measured at fair value as of December 31, 2019 and 2018 (in thousands): Total as of December 31, 2019 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 19,519 $ 19,519 $ — $ — Investments: U.S. government securities 32,175 32,175 — — Corporate securities 22,164 — 22,164 — Commercial paper 14,922 — 14,922 — Total investments $ 69,261 $ 32,175 $ 37,086 $ — Liabilities Warrant liabilities $ 150 $ — $ — $ 150 Total as of December 31, 2018 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 45,716 $ 45,716 $ — $ — Investments: U.S. government securities 38,737 38,737 — — Corporate securities 15,066 — 15,066 — Agency securities 11,931 — 11,931 — Commercial paper 1,183 1,183 — — Total investments $ 66,917 $ 39,920 $ 26,997 $ — Liabilities Warrant liabilities $ 860 $ — $ — $ 860 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The Company has determined that the warrant liabilities' fair values are Level 3 items within the fair value hierarchy. The following table presents the changes in the warrant liabilities (in thousands): Balance at December 31, 2018 $ 860 Exercise of warrants (18 ) Change in fair value of warrants (692 ) Balance at December 31, 2019 $ 150 |
Available-for-Sale Investment_2
Available-for-Sale Investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Debt Securities, Available-for-sale | The following table represents the Company’s available-for-sale investments by major security type as of December 31, 2019 and 2018 (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Fair Value Investments: Commercial paper $ 14,922 $ — $ — $ 14,922 Corporate securities 22,146 20 (2 ) 22,164 U.S. government securities 32,152 23 — 32,175 Total available-for-sale investments $ 69,220 $ 43 $ (2 ) $ 69,261 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Fair Value Investments: Agency securities $ 11,944 $ — $ (13 ) $ 11,931 Commercial paper 1,183 — — 1,183 Corporate securities 15,081 — (15 ) 15,066 U.S. government securities 38,761 — (24 ) 38,737 Total available-for-sale investments $ 66,969 $ — $ (52 ) $ 66,917 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities were excluded from the computation of diluted weighted average common shares outstanding due to their anti-dilutive effect: As of December 31, 2019 2018 Vested and unvested stock options 4,428,985 3,130,700 Restricted stock units 125,000 — Warrants 95,431 102,647 4,649,416 3,233,347 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | The following table summarizes the reporting of total stock-based compensation expense resulting from stock options, restricted stock units and the employee stock purchase plan (in thousands): Years Ended December 31, 2019 2018 Research and development $ 1,168 $ 518 Selling, general and administrative 5,316 1,210 Total stock-based compensation expense $ 6,484 $ 1,728 |
Summary of Valuation Allowance [Table Text Block] | A reconciliation of the beginning and ending amounts of valuation allowances for the years ended December 31, 2019 and 2018 is as follows (in thousands): Valuation allowance at December 31, 2017 $ (14,124 ) Increase for 2018 activity (18,538 ) Valuation allowance at December 31, 2018 (32,662 ) Increase for 2019 activity (36,288 ) Valuation allowance at December 31, 2019 $ (68,950 ) |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate of 21% to the Company’s effective income tax rate is as follows: Years Ended December 31, (in thousands) 2019 2018 Federal tax benefit at statutory rate $ (26,468 ) $ (12,617 ) State tax benefit, net of federal benefit (5,570 ) (1,842 ) Research and development and orphan drug credits (2,912 ) (2,279 ) Uncertain tax positions 342 603 Permanent adjustments to expenses 169 45 Stock-based compensation 683 76 Return to provision adjustment (3,278 ) (2,470 ) Rate impact of deferred tax balance — (63 ) Statutory rate differential (51 ) — Other 339 9 Changes in valuation allowance 36,288 18,538 Total income tax benefit $ (458 ) $ — |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, (in thousands) 2019 2018 Deferred tax assets: Net operating losses $ 55,110 $ 25,372 Federal research and orphan drug credits 8,309 5,426 Stock-based compensation 1,092 267 Other temporary differences 4,648 1,679 Valuation allowance (68,950 ) (32,662 ) Total assets 209 82 Deferred tax liabilities: Fixed and intangible assets (155 ) (82 ) Other deferred tax liabilities (54 ) — Total liabilities (209 ) (82 ) Net deferred tax assets $ — $ — |
Income Taxes Uncertain Tax Posi
Income Taxes Uncertain Tax Positions (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Summary of Positions for which Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Table Text Block] | The Company is required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. The Company accounts for the uncertainty in income taxes by utilizing a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken, or are expected to be taken, on an income tax return. The changes in the Company's uncertain income tax positions for the years ended December 31, 2019 and 2018 , excluding interest and penalties, consisted of the following (in thousands): December 31, 2019 2018 Beginning balance - uncertain tax positions $ 603 $ — Increases related to tax positions taken during the current year 246 228 Increases related to tax positions taken during the prior year 96 375 Ending balance - uncertain tax positions $ 945 $ 603 |
Organization and Nature of th_2
Organization and Nature of the Business Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Net sales | $ 1,627 | $ 0 | |
Accumulated deficit | $ 246,245 | $ 120,665 | $ 60,585 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Concentration risk, number of major customers | 3 | |
Capitalized costs, public offering costs | $ 0.4 | $ 0 |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Estimated Useful Lives | Lesser of useful life or lease term | |
Software | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Software | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies Summary of Accounting Policies (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Concentration risk, number of major customers | 3 | |
Concentration Risk, Percentage of Gross Revenue | 94.00% | |
Payments of public offering costs | $ 4,465 | $ 0 |
Payments for Initial Public Offering Costs | 0 | 9,422 |
Capitalized costs, public offering costs | $ 400 | $ 0 |
Concentration Risk, Percentage of Accounts Receivable | 97.00% |
Inventory Components of Invento
Inventory Components of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory [Line Items] | ||
Raw materials | $ 1,321 | $ 0 |
Work in process | 662 | 0 |
Finished goods | 193 | 0 |
Inventory | $ 2,176 | $ 0 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 9,341 | $ 2,685 |
Less: accumulated depreciation and amortization | (1,488) | (651) |
Property and equipment, net | 7,853 | 2,034 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,528 | 1,658 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,611 | 541 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 232 | 87 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 80 | 109 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 347 | 110 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,543 | $ 180 |
Property and Equipment Property
Property and Equipment Property and equipment details (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation Depletion and Amortization, not including asset impairments | $ 1,078,000 | $ 320,000 |
Other Accrued Liabilities Other
Other Accrued Liabilities Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued Expenses [Abstract] | ||
Accrued research and development costs | $ 7,062 | $ 2,221 |
Accrued employee costs | 6,818 | 4,326 |
Accrued marketing and selling costs | 1,973 | 0 |
Accrued interest expense | 449 | 274 |
Accrued other costs | 1,817 | 1,393 |
Other accrued liabilities | $ 18,119 | $ 8,214 |
Long-Term Debt Debt, Future Pri
Long-Term Debt Debt, Future Principal Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
Future principal payments, 2019 | $ 0 | |
Future principal payments, 2020 | 0 | |
Future principal payments, 2021 | 20,000 | |
Future principal payments, 2022 | 26,700 | |
Future principal payments, 2023 | 13,300 | |
Long-term Debt | $ 60,000 | $ 35,000 |
Long-Term Debt Narrative (Detai
Long-Term Debt Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Mar. 31, 2018 | |
Debt Instrument [Line Items] | |||||
Debt Instrument, Face Amount | $ 60,000 | $ 35,000 | |||
Prepayment allowed per debt agreement | $ 2,000 | ||||
Prepayment penalty percentage | 1.50% | ||||
Final payment fee percentage | 3.00% | ||||
Interest expense | $ (7,163) | (2,545) | |||
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net | (1,695) | (3,110) | |||
Long-term Debt | 58,305 | 31,890 | |||
Amortization of debt issuance costs | 948 | 560 | |||
2018 Term A Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Face Amount | 0 | 20,000 | $ 20,000 | ||
2018 Term B Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Face Amount | $ 0 | 15,000 | $ 15,000 | ||
2018 Loan and Security Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 45,000 | ||||
Interest rate, thirty-day LIBOR plus stated percentage | 8.84% | ||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | ||||
Debt Instrument, Payment Terms | P24M | ||||
Amended Loan and Security Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 85,000 | ||||
Debt Instrument, Interest Rate, Stated Percentage | 6.25% | ||||
Debt Instrument, Basis Spread on Variable Rate | 2.43% | ||||
Interest rate, stated percentage plus greater of (a) 2.43% or (b) thirty-day LIBOR | 8.68% | ||||
Term A Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Face Amount | $ 60,000 | $ 0 | 60,000 | ||
Debt Issuance Costs, Gross | $ 1,900 | ||||
Debt Instrument, Payment Terms | 27 | ||||
Term B Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Face Amount | 15,000 | ||||
Debt Instrument, Payment Terms | 30 | ||||
Term C Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Face Amount | $ 10,000 | ||||
Debt Instrument, Payment Terms | 21 | ||||
2018 Term A & B Loans [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Fee | 2.3 |
Public Stock Offerings Narrativ
Public Stock Offerings Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |||||||
Dec. 31, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Feb. 14, 2020 | Dec. 30, 2019 | Aug. 06, 2019 | Feb. 19, 2019 | Dec. 31, 2018 | Jun. 25, 2018 | |
Reverse Stock Split and Initial Public Offering [Abstract] | |||||||||
Common Shares, Par Value Per Share | $ 0.0001 | $ 0.0001 | |||||||
Common Shares, Shares, Issued | 27,214,523 | 10,299,769 | 204,427 | 5,996,775 | 20,808,366 | 6,555,000 | |||
Shares Issued, Price Per Share | $ 4.15 | $ 10 | $ 15 | ||||||
Common shares issued, due to exercise of underwriter option | 1,299,769 | 116,775 | 855,000 | ||||||
Net Proceeds from Issuance Initial Public Offering | $ 88.9 | ||||||||
Shares of common stock issued, after preferred stock conversion | 11,837,073 | ||||||||
Net proceeds from issuance of public offering | $ 1.7 | $ 55.5 | |||||||
Aggregate amount of common stock, available to sell under a shelf registration | $ 250 | ||||||||
Aggregate amount of common stock, available to sell under at-the-market (ATM) offering | $ 50 |
Convertible Preferred Stock Nar
Convertible Preferred Stock Narrative (Details) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018shares | Mar. 31, 2018USD ($)shares | Jun. 30, 2018 | Dec. 31, 2019shares | Dec. 31, 2018shares | |
Equity [Abstract] | |||||
Preferred Stock, Shares Issued | 707,680 | 0 | 0 | ||
Proceeds from Issuance of Preferred Stock, Preference Stock, and Warrants | $ | $ 4.4 | ||||
Shares of common stock issued, after preferred stock conversion | 11,837,073 | ||||
Reverse Stock Split, Conversion Ratio | 1.78112 | ||||
Preferred Stock, Dividend Rate, Percentage | 8.00% |
Warrants Schedule of Stockholde
Warrants Schedule of Stockholders' Equity Note, Warrants or Rights (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 95,431 |
2014 Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 1,419 |
Exercise Price Per Warrant | $ / shares | $ 5.912 |
Warrants Expiration Date | Aug. 31, 2020 |
Term A Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 53,720 |
Exercise Price Per Warrant | $ / shares | $ 11.169 |
Warrants Expiration Date | Feb. 28, 2025 |
Term B Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 40,292 |
Exercise Price Per Warrant | $ / shares | $ 11.169 |
Warrants Expiration Date | Sep. 7, 2025 |
Warrants Narrative (Details)
Warrants Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2014 | |
Class of Warrant or Right [Line Items] | |||||
Outstanding warrants | 95,431 | ||||
Change in fair value of warrants | $ (692) | $ (196) | |||
Term A Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Preferred stock and warrants issued during the period, shares | 53,720 | ||||
Exercise Price Per Warrant | $ 11.169 | ||||
Class of warrants, exercised | 0 | ||||
Outstanding warrants | 53,720 | ||||
Change in fair value of warrants | $ 351 | (108) | |||
Term B Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Preferred stock and warrants issued during the period, shares | 40,292 | ||||
Exercise Price Per Warrant | $ 11.169 | ||||
Class of warrants, exercised | 0 | ||||
Outstanding warrants | 40,292 | ||||
Change in fair value of warrants | $ 263 | 360 | |||
2014 Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Preferred stock and warrants issued during the period, shares | 19,931 | ||||
Exercise Price Per Warrant | $ 5.912 | ||||
Class of warrants, exercised | 18,512 | ||||
Outstanding warrants | 1,419 | ||||
Change in fair value of warrants | $ 78 | $ (56) |
Commitments and Contingencies N
Commitments and Contingencies Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Remaining future minimum lease payments, 2019 | $ 1,575,000 | |
Remaining future minimum lease payments, 2020 | 2,208,000 | |
Remaining future minimum lease payments, 2021 | 2,263,000 | |
Remaining future minimum lease payments, 2022 | 1,745,000 | |
Remaining future minimum lease payments, 2023 | 1,278,000 | |
Remaining future minimum lease payments, thereafter | 8,476,000 | |
Total minimum lease payments | 17,545,000 | |
Rent Expense, operating leases | 2,200,000 | $ 1,300,000 |
Letters of Credit Outstanding, Amount | $ 1,083,000 |
Stock Compensation Plan Share-b
Stock Compensation Plan Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Method Used (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 years | 6 years |
Risk-free interest rate | 2.14% | 2.48% |
Expected volatility | 60.27% | 56.84% |
Expected dividends | 0.00% | 0.00% |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 months 20 days | |
Risk-free interest rate | 1.85% | |
Expected volatility | 70.70% | |
Expected dividends | 0.00% |
Stock Compensation Plan Employe
Stock Compensation Plan Employee Stock Award Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 4,428,985 | 3,130,700 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 9.40 | $ 8.06 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 69 days | 8 years 252 days |
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 1,600,650 | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 12.21 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | (128,307) | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ 1.99 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Options Forfeited, Number of Shares | (172,655) | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period, Weighted Average Exercise Price | $ 16.33 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period | (1,403) | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price | $ 19.77 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,647,911 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 6.07 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 7 years 113 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 4,202,205 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ 9.32 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 8 years 58 days | |
Share-based Payment Arrangement, Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.14% | 2.48% |
Stock Compensation Plan Narrati
Stock Compensation Plan Narrative (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2011 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Least amount of annual increase of shares available for issuance | 386,000 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 73,607 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||
Share-based Payment Arrangement, Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value | $ 6.97 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 1,000,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Aggregate Intrinsic Value | 7,800,000 | ||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 14,100,000 | ||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 120 days | ||||
Non--employee stock options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 2 years | ||||
2011 Stock Option Issuance Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 4,714,982 | ||||
2018 Stock Option and Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,822,000 | ||||
Percentage shares available for issuance automatically increase annually | 4.00% | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 835,728 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 809,000 | ||||
Employee Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 193,000 | ||||
Maximum employee payroll deduction percentage | 15.00% | ||||
Common stock value, tax limit on employee stock purchase plan | $ 25,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | 85.00% | ||||
Percentage shares available for issuance automatically increase annually | 1.00% | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 208,932 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 73,607 | ||||
Employee Stock Ownership Plan (ESOP), Weighted Average Purchase Price of Shares Purchased | $ 7.22 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 328,000 | ||||
Equity Inducement Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 750,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 340,000 |
Stock Compensation Plan Stock-B
Stock Compensation Plan Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 6,484 | $ 1,728 |
Research and development expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 1,168 | 518 |
Selling, General and Administrative Expenses [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 5,316 | $ 1,210 |
Stock Compensation Plan Restric
Stock Compensation Plan Restricted stock units, activity (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 4,428,985 | 3,130,700 |
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 1,600,650 | |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.85% | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 1.3 | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 3 years 50 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 125,000 | 0 |
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 125,000 |
Fair Value Measurement Fair Val
Fair Value Measurement Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and money market funds | $ 19,519 | $ 45,716 |
Investments | 69,261 | 66,917 |
Other current liabilities | 150 | 860 |
Exercise of warrants | (18) | |
Change in fair value of warrants | 692 | 196 |
Term A Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of warrants | (351) | 108 |
Term B Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of warrants | (263) | (360) |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 19,519 | 45,716 |
Investments | 32,175 | 39,920 |
Other current liabilities | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 0 | 0 |
Investments | 37,086 | 26,997 |
Other current liabilities | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and money market funds | 0 | 0 |
Investments | 0 | 0 |
Other current liabilities | 150 | 860 |
U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 32,175 | 38,737 |
U.S. government securities | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 32,175 | 38,737 |
U.S. government securities | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
U.S. government securities | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Corporate securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 22,164 | 15,066 |
Corporate securities | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Corporate securities | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 22,164 | 15,066 |
Corporate securities | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 11,931 | |
Agency securities | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Agency securities | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 11,931 | |
Agency securities | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 14,922 | 1,183 |
Commercial paper | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 1,183 |
Commercial paper | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 14,922 | 0 |
Commercial paper | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | $ 0 |
Available-for-Sale Investment_3
Available-for-Sale Investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Securities, Available-for-sale [Line Items] | ||
Available For Sale Securities Maturities Period | 255 days | |
Amortized Cost | $ 69,220 | $ 66,969 |
Gross Unrealized Gains | 43 | 0 |
Gross Unrealized Losses | (2) | (52) |
Investments | 69,261 | 66,917 |
Agency securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 11,944 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (13) | |
Investments | 11,931 | |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 14,922 | 1,183 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Investments | 14,922 | 1,183 |
Corporate securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 22,146 | 15,081 |
Gross Unrealized Gains | 20 | 0 |
Gross Unrealized Losses | (2) | (15) |
Investments | 22,164 | 15,066 |
U.S. government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 32,152 | 38,761 |
Gross Unrealized Gains | 23 | 0 |
Gross Unrealized Losses | 0 | (24) |
Investments | $ 32,175 | $ 38,737 |
Net Loss Per Share Antidilutive
Net Loss Per Share Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,649,416 | 3,233,347 |
Vested and unvested stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,428,985 | 3,130,700 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 125,000 | 0 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 95,431 | 102,647 |
Defined Contribution Plan Defin
Defined Contribution Plan Defined Contribution Plan (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan, Matching Contributions | $ 0.4 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Valuation Allowance [Line Items] | |||
Operating Loss Carryforwards | $ 215,300,000 | $ 108,800,000 | |
Effective Income Tax Rate Reconciliation, Deduction, Percent | 80.00% | ||
Federal research income tax credits, gross of valuation allowance | $ 8,300,000 | 5,800,000 | |
State research income tax credits, gross of valuation allowance | 1,000,000 | 2,000,000 | |
Operating loss carryforwards, various states | 147,500,000 | 35,600,000 | |
Federal tax benefit at statutory rate | (26,468,000) | (12,617,000) | |
Effective Income Tax Rate Reconciliation, State and Local Income Taxes, Amount | (5,570,000) | (1,842,000) | |
Unrecognized Tax Benefits | $ 945,000 | 603,000 | $ 0 |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | ||
Unrecognized Tax Benefits, Period Increase (Decrease) | $ 246,000 | 228,000 | |
Unrecognized Tax Benefits, Increase Resulting from Prior Period Tax Positions | 96,000 | 375,000 | |
Net operating losses | 55,110,000 | 25,372,000 | |
Deferred Tax Assets, Tax Credit Carryforwards, Research | 8,309,000 | 5,426,000 | |
Stock compensation | 1,092,000 | 267,000 | |
Other temporary differences | 4,648,000 | 1,679,000 | |
Valuation allowance | (68,950,000) | (32,662,000) | $ (14,124,000) |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | (36,288,000) | (18,538,000) | |
Total deferred tax assets | 209,000 | 82,000 | |
Fixed and intangible assets | (155,000) | (82,000) | |
Deferred Tax Liabilities, Other | (54,000) | 0 | |
Total deferred tax liabilities | (209,000) | (82,000) | |
Net deferred tax assets | 0 | 0 | |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | 36,288,000 | 18,538,000 | |
Benefit from income taxes | (458,000) | 0 | |
Income Tax Examination, Penalties and Interest Expense | 0 | ||
Effective Income Tax Rate Reconciliation, Tax Credit, Research, Amount | (2,912,000) | (2,279,000) | |
Unrecognized Tax Benefits, Decrease Resulting from Current Period Tax Positions | 342,000 | 603,000 | |
Effective Income Tax Rate Reconciliation, Other Adjustments, Amount | 169,000 | 45,000 | |
Effective Income Tax Rate Reconciliation, Tax Expense (Benefit), Share-based Payment Arrangement, Amount | 683,000 | 76,000 | |
Effective Income Tax Rate Reconciliation, Prior Year Income Taxes, Amount | (3,278,000) | (2,470,000) | |
Income Tax Expense (Benefit), Continuing Operations, Adjustment of Deferred Tax (Asset) Liability | 0 | (63,000) | |
Effective Income Tax Rate Reconciliation, Other Reconciling Items, Amount | $ 339,000 | $ 9,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Feb. 29, 2020 | Jun. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Feb. 14, 2020 | Dec. 30, 2019 | Feb. 19, 2019 | Jun. 25, 2018 | |
Subsequent Event [Line Items] | ||||||||
Proceeds from public offerings | $ 42,700,000 | $ 61,692,000 | $ 0 | |||||
Net Proceeds from Issuance Initial Public Offering | $ 88,900,000 | |||||||
Common Shares, Shares, Issued | 27,214,523 | 20,808,366 | 10,299,769 | 204,427 | 5,996,775 | 6,555,000 | ||
Shares Issued, Price Per Share | $ 4.15 | $ 10 | $ 15 | |||||
Common shares issued, due to exercise of underwriter option | 1,299,769 | 116,775 | 855,000 | |||||
Maximum common shares issued under underwriter option | 1,350,000 |