Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 24, 2020 | Jun. 28, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Entity Registrant Name | Aclaris Therapeutics, Inc. | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 79.6 | ||
Entity Common Stock, Shares Outstanding | 41,528,822 | ||
Entity Central Index Key | 0001557746 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash, cash equivalents and restricted cash | $ 35,937 | $ 57,019 |
Marketable securities | 39,078 | 110,953 |
Accounts receivable, net | 704 | 563 |
Inventory | 0 | 791 |
Prepaid expenses and other current assets | 3,118 | 4,802 |
Discontinued operations - current assets | 4,966 | 6,162 |
Total current assets | 83,803 | 179,499 |
Property and equipment, net | 2,470 | 2,287 |
Intangible assets | 7,199 | 7,274 |
Goodwill | 18,504 | |
Other assets | 4,825 | 332 |
Discontinued operations - non-current assets | 67,670 | |
Total assets | 98,297 | 275,566 |
Current liabilities: | ||
Accounts payable | 9,917 | 11,675 |
Accrued expenses | 7,721 | 8,088 |
Current portion of lease liabilities | 637 | 142 |
Discontinued operations - current liabilities | 4,157 | 7,437 |
Total current liabilities | 22,432 | 27,342 |
Other liabilities | 3,736 | 476 |
Long-term debt | 29,914 | |
Contingent consideration | 1,668 | 934 |
Deferred tax liability | 549 | 549 |
Discontinued operations - non-current liabilities | 1,227 | |
Total liabilities | 28,385 | 60,442 |
Stockholders' Equity: | ||
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at December 31, 2019 and December 31, 2018 | ||
Common stock, $0.00001 par value; 100,000,000 shares authorized at December 31, 2019 and December 31, 2018; 41,485,638 and 41,210,725 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | ||
Additional paid-in capital | 523,505 | 507,366 |
Accumulated other comprehensive loss | (66) | (69) |
Accumulated deficit | (453,527) | (292,173) |
Total stockholders’ equity | 69,912 | 215,124 |
Total liabilities and stockholders’ equity | $ 98,297 | $ 275,566 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 41,485,638 | 41,210,725 |
Common stock, shares outstanding | 41,485,638 | 41,210,725 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue, net | $ 4,227 | $ 6,151 | $ 1,683 |
Costs and expenses: | |||
Cost of revenue | 4,055 | 4,329 | 1,207 |
Research and development | 64,899 | 60,841 | 35,804 |
Sales and marketing | 671 | 170 | 85 |
General and administrative | 27,156 | 25,591 | 18,948 |
Goodwill impairment | 18,504 | ||
Amortization of definite-lived intangible | 4,426 | 552 | |
Total costs and expenses | 115,285 | 90,931 | 56,044 |
Loss from operations | (111,058) | (84,780) | (54,361) |
Other income (expense), net | (2,484) | 2,676 | 2,070 |
Loss from continuing operations | (113,542) | (82,104) | (52,291) |
Loss from discontinued operations | (47,812) | (50,634) | (18,062) |
Loss before income taxes | (161,354) | (132,738) | (70,353) |
Income taxes | (1,830) | ||
Net loss | $ (161,354) | $ (132,738) | $ (68,523) |
Net loss per share, basic and diluted | $ (3.90) | $ (4.03) | $ (2.44) |
Weighted average common shares outstanding, basic and diluted (in shares) | 41,323,921 | 32,909,762 | 28,102,386 |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on marketable securities, net of tax of $0 | $ 28 | $ 145 | $ (121) |
Foreign currency translation adjustments | (25) | 32 | 144 |
Total other comprehensive income | 3 | 177 | 23 |
Comprehensive loss | (161,351) | (132,561) | (68,500) |
Contract research | |||
Revenue, net | $ 4,227 | 4,651 | $ 1,683 |
Other revenue | |||
Revenue, net | $ 1,500 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||
Unrealized gain (loss) on marketable securities, tax | $ 0 | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common StockFollow On Public Offering | Common StockAt The Market Offering | Common Stock | Additional Paid-in CapitalFollow On Public Offering | Additional Paid-in CapitalAt The Market Offering | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit | Follow On Public Offering | At The Market Offering | Total |
Balance at beginning of period at Dec. 31, 2016 | $ 260,671 | $ (269) | $ (90,912) | $ 169,490 | |||||||
Balance at beginning of period (in shares) at Dec. 31, 2016 | 26,059,181 | ||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Issuance of common stock | $ 80,918 | $ 19,311 | $ 80,918 | $ 19,311 | |||||||
Number of shares issued | 3,747,602 | 635,000 | |||||||||
Issuance of common stock in connection with acquisition | 9,675 | 9,675 | |||||||||
Issuance of common stock in connection with acquisition, shares | 349,527 | ||||||||||
Exercise of stock options and vesting of RSUs | (62) | (62) | |||||||||
Exercise of stock options and vesting of RSUs, shares | 65,195 | ||||||||||
Unrealized gain (loss) on marketable securities | (121) | (121) | |||||||||
Foreign currency translation adjustment | 144 | 144 | |||||||||
Stock-based compensation expense | 14,430 | 14,430 | |||||||||
Net loss | (68,523) | (68,523) | |||||||||
Balance at end of period at Dec. 31, 2017 | 384,943 | (246) | (159,435) | 225,262 | |||||||
Balance at end of period (in shares) at Dec. 31, 2017 | 30,856,505 | ||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Issuance of common stock | $ 100,205 | $ 100,205 | |||||||||
Number of shares issued | 9,941,750 | ||||||||||
Issuance of common stock in connection with acquisition | 2,215 | 2,215 | |||||||||
Issuance of common stock in connection with acquisition, shares | 253,181 | ||||||||||
Exercise of stock options and vesting of RSUs | (52) | (52) | |||||||||
Exercise of stock options and vesting of RSUs, shares | 159,289 | ||||||||||
Unrealized gain (loss) on marketable securities | 145 | 145 | |||||||||
Foreign currency translation adjustment | 32 | 32 | |||||||||
Stock-based compensation expense | 20,055 | 20,055 | |||||||||
Net loss | (132,738) | (132,738) | |||||||||
Balance at end of period at Dec. 31, 2018 | 507,366 | (69) | (292,173) | $ 215,124 | |||||||
Balance at end of period (in shares) at Dec. 31, 2018 | 41,210,725 | 41,210,725 | |||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Exercise of stock options and vesting of RSUs | (38) | $ (38) | |||||||||
Exercise of stock options and vesting of RSUs, shares | 274,913 | ||||||||||
Unrealized gain (loss) on marketable securities | 28 | 28 | |||||||||
Foreign currency translation adjustment | (25) | (25) | |||||||||
Stock-based compensation expense | 16,177 | 16,177 | |||||||||
Net loss | (161,354) | (161,354) | |||||||||
Balance at end of period at Dec. 31, 2019 | $ 523,505 | $ (66) | $ (453,527) | $ 69,912 | |||||||
Balance at end of period (in shares) at Dec. 31, 2019 | 41,485,638 | 41,485,638 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Private Placement | ||
Offering costs netted against proceeds | $ 5,352 | |
Follow On Public Offering | ||
Offering costs netted against proceeds | $ 6,669 | |
At The Market Offering | ||
Offering costs netted against proceeds | $ 691 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net loss | $ (161,354) | $ (132,738) | $ (68,523) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 6,409 | 1,879 | 402 |
Stock-based compensation expense | 16,177 | 20,055 | 14,430 |
Change in fair value of contingent consideration | 734 | 1,272 | |
Goodwill impairment charge | 18,504 | ||
Intangible asset impairment charge | 27,638 | ||
Payment of Confluence development milestone | (717) | ||
Gain on sale of RHOFADE | (1,850) | ||
Deferred taxes | (1,837) | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | (809) | (4,380) | |
Inventory | 605 | 102 | |
Prepaid expenses and other assets | 2,628 | (40) | (4,306) |
Accounts payable | (3,160) | 6,964 | 4,564 |
Accrued expenses | (1,967) | 6,792 | 607 |
Net cash used in operating activities | (96,445) | (100,811) | (54,663) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (1,613) | (1,356) | (1,235) |
Acquisition of RHOFADE | (67,122) | ||
Disposition of RHOFADE | 34,186 | ||
Acquisition of Confluence, net of cash acquired | (9,647) | ||
Purchases of marketable securities | (137,385) | (161,598) | (197,337) |
Proceeds from sales and maturities of marketable securities | 210,491 | 239,443 | 152,527 |
Net cash provided by (used in) investing activities | 105,679 | 9,367 | (55,692) |
Cash flows from financing activities: | |||
Proceeds from debt financing, net of issuance costs | 29,910 | ||
Loan amount borrowed | (30,000) | ||
Payment of Confluence development milestone | (1,783) | ||
Finance lease payments | (523) | (648) | (78) |
Proceeds from the exercise of employee stock options | 207 | 577 | 235 |
Net cash (used in) provided by financing activities | (30,316) | 128,261 | 100,386 |
Net increase (decrease) in cash and cash equivalents | (21,082) | 36,817 | (9,969) |
Cash, cash equivalents and restricted cash at beginning of period | 57,019 | 20,202 | 30,171 |
Cash, cash equivalents and restricted cash at end of period | 35,937 | 57,019 | 20,202 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Additions to property and equipment included in accounts payable | 124 | 161 | 274 |
Operating lease asset recorded as a result of new accounting standard | $ 2,132 | ||
Fair value of stock issued in connection with Confluence development milestone | 2,215 | ||
Fair value of stock issued in connection with Confluence acquisition | 2,131 | 9,675 | |
Offering costs included in accounts payable | 210 | 20 | |
At The Market Offering | |||
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net of issuance costs | 19,311 | ||
Follow On Public Offering | |||
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net of issuance costs | $ 100,205 | $ 80,918 |
Organization and Nature of Busi
Organization and Nature of Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Nature of Business | |
Organization and Nature of Business | 1. Organization and Nature of Business Overview Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012. In July 2015, Aclaris Therapeutics International Limited (“ATIL”) was established under the laws of the United Kingdom as a wholly-owned subsidiary of Aclaris Therapeutics, Inc. In March 2016, Vixen Pharmaceuticals, Inc. (“Vixen”) became a wholly-owned subsidiary of Aclaris Therapeutics, Inc., and in September 2018, Vixen was dissolved. In August 2017, Confluence Life Sciences, Inc., now known as Aclaris Life Sciences, Inc. (“Confluence”) was acquired by Aclaris Therapeutics, Inc. and became a wholly-owned subsidiary thereof. Aclaris Therapeutics, Inc., ATIL, Vixen and Confluence are referred to collectively as the “Company”. The Company is a physician-led biopharmaceutical company focused on immuno-inflammatory diseases. The Company currently has a pipeline of drug candidates focused on immuno-inflammatory diseases, as well as one product approved by the U.S. Food and Drug Administration (“FDA”) that it is not currently distributing, marketing or selling, and other investigational drug candidates. In September 2019, the Company announced the completion of a strategic review of its business, as a result of which it is refocusing its resources on its immuno-inflammatory development programs. The Company plans to pursue strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize its drug candidates and ESKATA (hydrogen peroxide) topical solution, 40% (w/w) (“ESKATA”), the Company’s non-marketed FDA-approved product. Liquidity The Company’s consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. At December 31, 2019, the Company had cash, cash equivalents and marketable securities of $75,015 and an accumulated deficit of $453,527. Since inception, the Company has incurred net losses and negative cash flows from its operations. Prior to the acquisition of Confluence in August 2017, the Company had never generated revenue. There can be no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, including clinical and preclinical testing of the Company’s drug candidates, will require significant additional financing. The future viability of the Company is dependent on its ability to successfully develop its drug candidates and to generate revenue from identifying and consummating transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize its development assets or to raise additional capital to finance its operations. The Company expects that it will require additional capital to complete the clinical development of ATI-450, to develop its preclinical compounds, and to support its discovery efforts. Additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable the Company to continue to implement its long-term business strategy. If the Company is unable to raise sufficient additional capital or generate revenue from transactions with third-party partners for the development and/or commercialization of its drug candidates, it may need to substantially curtail planned operations. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that its consolidated financial statements are issued. As of the report date, the Company believes the actions described below are probable of being implemented effectively and of alleviating the conditions or events that exist which raise substantial doubt about its ability to continue as a going concern within one year after the date of the issuance of these consolidated financial statements. The Company believes its existing cash, cash equivalents and marketable securities are sufficient to fund its operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of these consolidated financial statements. The Company has taken a number of actions to support its operations and meet its liquidity needs. In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to pursue strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize its drug candidates and ESKATA . As a result of this decision, the Company restructured its operations and terminated employees, some of which are occurring through termination dates into 2020, which will result in lower operating costs in the future. In October 2019, the Company sold the worldwide rights to RHOFADE to further its focus on its development programs and improve cash flow. The Company’s plans to further alleviate the substantial doubt about its going concern, which are probable of effectively being implemented and mitigating these conditions, primarily include its ability to control the timing and spending on its research and development programs. The Company may also consider other plans to fund its operations including: (1) raising additional capital through debt or equity financings; (2) identification of third-party partners to further develop, obtain marketing approval for and/or commercialize its drug candidates and ESKATA, which may generate revenue and/or milestone payments; (3) reducing spending on one or more research and development programs by delaying or discontinuing development; and/or (4) further restructuring its operations to change its overhead structure. Finally, additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable the Company to continue to implement its long-term business strategy. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly-owned subsidiaries, Confluence, ATIL and Vixen. All significant intercompany transactions have been eliminated. Based upon the revenue from contract research services, the Company believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the consolidated statement of operations. Discontinued Operations In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products. The Company also announced a plan to terminate 86 employees (see Note 17). The accompanying consolidated financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to the Company’s commercial products as discontinued operations (see Note 18). The accompanying consolidated financial statements are generally presented in conformity with the Company’s historical format, even in certain situations where reclassifications to discontinued operations have resulted in $0 values being presented. The Company believes this format provides comparability with its previously filed financial statements. 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 and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, research and development expenses, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. Revenue Recognition The Company accounts for revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable. Product Sales, net The Company sold RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) and ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w) (“ESKATA”) during the years ended December 31, 2019 and 2018 to a limited number of wholesalers in the United States (collectively, its “Customers”). These Customers subsequently resold the Company’s products to pharmacies and health care providers. In addition to distribution agreements with Customers, the Company entered into, or was subject to, arrangements with third-party payors, including pharmacy benefit managers and government agencies, as well as group purchasing organizations (“GPOs”), which provided for government mandated or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s commercial products. The Company discontinued selling ESKATA in August 2019. The Company sold the worldwide rights to RHOFADE in October 2019 (see Note 3). Product sales, net has been reclassified to discontinued operations for all periods presented. The Company recognized revenue from product sales at the point the Customer obtained control of the product, which generally occurred upon delivery. The Company also included estimates of variable consideration in the same period revenue was recognized. Components of variable consideration include trade discounts and allowances, product returns, government rebates, discounts and rebates, other incentives such as patient co-pay assistance, and other fee for service amounts. Variable consideration was recorded on the consolidated balance sheet as either a reduction of accounts receivable, if payable to a Customer, or as a current liability, if payable to a third party other than a Customer. The Company considered all relevant information when estimating variable consideration such as contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of net revenue that can be recognized is constrained by estimates of variable consideration which are included in the transaction price. Payment terms with Customers did not exceed one year and, therefore, the Company did not account for a financing component in its arrangements. The Company expensed incremental costs of obtaining a contract with a Customer, including sales commissions, when incurred as the period of benefit was less than one year. Trade Discounts and Allowances - The Company provided Customers with trade discounts, rebates, allowances and/or other incentives. The Company recorded estimates for these items as a reduction of revenue in the same period the revenue was recognized. Government and Payor Rebates - The Company contracted with, or was subject to arrangements with, certain third-party payors, including pharmacy benefit managers and government agencies, for the payment of rebates with respect to utilization of its commercial products. The Company also entered into agreements with GPOs that provided for administrative fees and discounted pricing in the form of volume-based rebates. The Company was also subject to discount and rebate obligations under state Medicaid programs and Medicare. The Company recorded estimates for these discounts and rebates as a reduction of revenue in the same period the revenue was recognized. Other Incentives - The Company maintained a co-pay assistance program which was intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by third-party payors. The Company estimated and recorded accruals for these incentives as a reduction of revenue in the period the revenue was recognized. The Company estimated amounts for co-pay assistance based upon the number of claims and the cost per claim that the Company expected to receive associated with product that had been sold to Customers but remained in the distribution channel at the end of each reporting period. Product Returns - Consistent with industry practice, the Company has a product returns policy for RHOFADE that provides Customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The right of return lapses upon shipment of the product to a patient. The Company recorded an estimate for the amount of its products which may be returned as a reduction of revenue in the period the related revenue was recognized. The Company’s estimate for product returns was based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. There is no return liability associated with sales of ESKATA as the Company had a no returns policy for ESKATA when it was commercialized. Contract Research The Company earns contract research revenue from the provision of laboratory services to clients through Confluence, its wholly-owned subsidiary. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis and are generally billed on a monthly basis in arrears for services rendered. Revenue related to these contracts is generally recognized as the laboratory services are performed, based upon the rates specified in the contracts. Under ASC Topic 606, the Company elected to apply the “right to invoice” practical expedient when recognizing contract research revenue. The Company recognizes contract research revenue in the amount to which it has the right to invoice. The Company has also received revenue from grants under the Small Business Innovation Research program of the National Institutes of Health (“NIH”). During the year ended December 31, 2018, the Company had two active grants from NIH which were related to early-stage research. As of December 31, 2019, there were no remaining funds available to the Company under the grants. The Company recognizes revenue related to grants as amounts become reimbursable under each grant, which is generally when research is performed, and the related costs are incurred. Other Revenue Licenses of Intellectual Property – The Company recognizes revenue received from non-refundable, upfront fees related to the licensing of intellectual property when the intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the license has been transferred to the customer, and the customer is able to use and benefit from the license. Milestone Payments – At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the amount allocated to the license of intellectual property. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. Cash, Cash Equivalents and Restricted Cash The Company considers all short-term, highly liquid investments with original maturities of 90 days or less at acquisition date to be cash equivalents. Cash equivalents, which have consisted of money market accounts, commercial paper and corporate debt securities with original maturities of less than three months, are stated at fair value. Restricted cash as of December 31, 2019 included $1,750 placed in escrow pursuant to the asset purchase agreement with EPI Health, LLC (“EPI Health”) (see Note 3). Marketable Securities Marketable securities with original maturities of greater than three months and remaining maturities of less than one year from the balance sheet date are classified as short-term. Marketable securities with remaining maturities of greater than one year from the balance sheet date are classified as long-term. The Company classifies all of its marketable securities as available-for-sale securities. The Company’s marketable securities are measured and reported at fair value using quoted prices in markets that are not active for identical or similar securities. Unrealized gains and losses are reported as a separate component of stockholders’ equity. The cost of securities sold is determined on a specific identification basis, and realized gains and losses, if any, are included in other income, net within the consolidated statement of operations and comprehensive loss. If any adjustment to fair value reflects a decline in the value of the investment, the Company considers available evidence to evaluate the extent to which the decline is “other than temporary” and reduces the investment to fair value through a charge to the statement of operations and comprehensive loss. Inventory Inventory includes the third-party cost of manufacturing and assembly of finished product, quality control and other overhead costs. Inventory is stated at the lower of cost or net realizable value. Inventory is adjusted for short-dated, unmarketable inventory equal to the difference between the cost of inventory and the estimated value based upon assumptions about future demand and market conditions. The Company had $0 and $791 of inventory as of December 31, 2019 and 2018, respectively, which was comprised primarily of finished goods and has been reclassified to discontinued operations for all periods presented. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the useful life of the asset. Computer equipment is depreciated over three years. Manufacturing and laboratory equipment is depreciated over five years. Furniture and fixtures are depreciated over five years. Leasehold improvements are depreciated over the shorter of the lease term or their useful life. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in loss from operations. Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. Intangible Assets Intangible assets include both definite-lived and indefinite-lived assets. Definite-lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used. Definite-lived intangible assets consist of a research technology platform the Company acquired through the acquisition of Confluence. Prior to the disposition in 2019, definite-lived intangible assets also included the intellectual property rights related to RHOFADE. Indefinite-lived intangible assets consist of an in-process research and development (“IPR&D”) drug candidate acquired through the acquisition of Confluence. IPR&D assets are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. The cost of IPR&D is either amortized over its estimated useful life beginning when the underlying drug candidate is approved and launched commercially, or expensed immediately if development of the drug candidate is abandoned. Definite-lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Indefinite-lived intangible assets are tested for impairment at least annually, which the Company performs during the fourth quarter, or when indicators of an impairment are present. The Company recognizes impairment losses when and to the extent that the estimated fair value of an intangible asset is less than its carrying value. During the year ended December 31, 2019, the Company performed an impairment analysis of the RHOFADE intangible asset due to its decision to discontinue commercial operations and actively seek a commercialization partner for RHOFADE. The Company’s impairment analysis, which primarily utilized a market-participant’s indication of fair value, resulted in a fair value for the RHOFADE intangible asset which was less than its carrying value. As a result, the Company recorded an impairment charge of $27,638, which is included in discontinued operations on the consolidated statement of operations, to adjust the carrying value of the RHOFADE intangible asset to its net realizable value (see Note 3). Goodwill Goodwill is not amortized, but rather is subject to testing for impairment at least annually, which the Company performs either during the fourth quarter or when indicators of an impairment are present. The Company considers each of its operating segments, therapeutics and contract research, to be a reporting unit since this is the lowest level for which discrete financial information is available. The Company attributed the full amount of the goodwill acquired with Confluence, or $18,504, to the therapeutics segment. The annual impairment test performed by the Company is a qualitative assessment based upon current facts and circumstances related to operations of the therapeutics segment. If the qualitative assessment indicates an impairment may be present, the Company would perform the required quantitative analysis and an impairment charge would be recognized to the extent that the estimated fair value of the reporting unit is less than its carrying amount. However, any loss recognized would not exceed the total amount of goodwill allocated to that reporting unit. During the year ended December 31, 2019, the Company performed an impairment analysis due to the decline in its stock price, which was considered a triggering event to evaluate goodwill for impairment. The Company’s impairment analysis, using a market approach, noted that its stock price, including a reasonable control premium, resulted in a fair value for the therapeutics reporting unit which was less than its carrying value. As a result, the Company recorded an impairment charge of $18,504, the full balance of goodwill. Leases Leases represent a company’s right to use an underlying asset and a corresponding obligation to make payments to a lessor for the right to use those assets. The Company evaluates leases at their inception to determine if they are an operating lease or a finance lease. A lease is accounted for as a finance lease if it meets one of the following five criteria: the lease has a purchase option that is reasonably certain of being exercised, the present value of the future cash flows are substantially all of the fair market value of the underlying asset, the lease term is for a significant portion of the remaining economic life of the underlying asset, the title to the underlying asset transfers at the end of the lease term, or if the underlying asset is of such a specialized nature that it is expected to have no alternative uses to the lessor at the end of the term. Leases that do not meet the finance lease criteria are accounted for as an operating lease. The Company recognizes assets and liabilities for leases at their inception based upon the present value of all payments due under the lease. The Company uses an implicit interest rate to determine the present value of finance leases, and its incremental borrowing rate to determine the present value of operating leases. The Company determines incremental borrowing rates by referencing collateralized borrowing rates for debt instruments with terms similar to the respective lease. The Company recognizes expense for operating and finance leases on a straight-line basis over the term of each lease, and interest expense related to finance leases is recognized over the lease term based on the effective interest method. The Company includes estimates for any residual value guarantee obligations under its leases in lease liabilities recorded on its consolidated balance sheet. Right-of-use assets are included in other assets and property and equipment, net on the Company’s consolidated balance sheet for operating and finance leases, respectively. Obligations for lease payments are included in current portion of lease liabilities and other liabilities on the Company’s consolidated balance sheet for both operating and finance leases. Contingent Consideration The Company initially recorded the contingent consideration related to future potential payments based upon the achievement of certain development, regulatory and commercial milestones, resulting from the acquisition of Confluence, at its estimated fair value on the date of acquisition. Changes in fair value reflect new information about the likelihood of the payment of the contingent consideration and the passage of time. For example, if the timing of the development of an acquired drug candidate, or the size of potential commercial opportunities related to an acquired drug, differ from the Company’s assumptions, then the fair value of contingent consideration would be adjusted accordingly. Future changes in the fair value of the contingent consideration, if any, will be recorded as income or expense in the Company’s consolidated statement of operations. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses include salaries, stock-based compensation and benefits of employees, fees paid under licensing agreements, fees paid under a third party assignment agreement and other operational costs related to the Company’s research and development activities, including depreciation expenses and the cost of research and development contracts which the Company has entered into with outside vendors to conduct both preclinical studies and clinical trials. Significant judgment and estimates are made in determining the amount of research and development costs recognized in each reporting period. The Company analyzes the progress of its preclinical studies and clinical trials, completion of milestone events, invoices received and contracted costs when estimating research and development costs. Actual results could differ from the Company’s estimates. The Company’s historical estimates for research and development costs have not been materially different from the actual costs. Stock-Based Compensation The Company measures the compensation expense of stock-based awards granted to employees and directors using the grant date fair value of the award. The Company has issued stock options and restricted stock unit (“RSU”) awards with service-based vesting conditions, as well as with performance-based vesting conditions. The Company has not issued awards that include market-based conditions. For service-based awards the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period. For performance-based awards the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period beginning in the period that it becomes probable the performance conditions will occur. At each balance sheet date, the Company evaluates whether any performance conditions related to a performance-based award have changed. The effect of any change in performance conditions would be recognized as a cumulative catch-up adjustment in the period such change occurs, and any remaining unrecognized compensation expense would be recognized on a straight-line basis over the remaining requisite service period. The impact of forfeitures is recognized in the period in which they occur. The Company initially measures the compensation expense of stock-based awards granted to consultants using the grant date fair value of the award. Compensation expense is recognized over the period during which services are rendered by such consultants. At the end of each financial reporting period prior to completion of services being rendered, the compensation expense related to these awards is remeasured using the then current fair value of the Company’s common stock for RSUs, or based upon updated assumptions in the Black-Scholes option pricing model for stock option awards. The Company classifies stock-based compensation expense in its statement of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company estimates its expected stock volatility based on the historical volatility of a set of peer companies, which are publicly traded, and expects to continue to do so until it has adequate historical data regarding the volatility of its own publicly-traded stock price. The expected term of the Company’s stock options has been determined using the “simplified” method for awards that qualify as “plain vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the future. Prior to the Company’s initial public offering in October 2015 (“IPO”), the Company valued its common stock using a hybrid method to estimate its enterprise value. The hybrid method used was a probability-weighted expected return method which was a scenario-based methodology that estimated the fair value of the Company’s common stock based upon an analysis of future values for the Company assuming various outcomes. The hybrid method used calculated equity values using an option pricing model in one or more of scenarios, and also considered the rights of each class of stock. The fair value of each RSU is measured using the closing price of the Company’s common stock on the date of grant. Patent Costs All patent related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Foreign Currency Translation The reporting currency of the Company is the U.S. Dollar. The functional currency of ATIL, the Company’s wholly-owned subsidiary, is the British Pound. Assets and liabilities of ATIL are translated into U.S. Dollars based on exchange rates at the end of each reporting period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive loss within the Company’s consolidated balance sheet. Gains and losses resulting from foreign currency transactions are reflected within the Company’s consolidated statement of operations. The Company has not utilized foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. Comprehensive loss is comprised of net loss, foreign currency translation adjustments and unrealized gains (losses) on marketable securities. Net Loss per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period, plus the weighted average number of potential shares of common stock from the assumed exercise of stock options, and the assumed vesting of RSUs and restricted stock granted by the Company upon its formation, if dilutive. Since the Company was in a net loss position basic and diluted net loss per share was the same for each of the periods presented. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents, marketab |
RHOFADE
RHOFADE | 12 Months Ended |
Dec. 31, 2019 | |
RHOFADE | |
RHOFADE | 3. RHOFADE Disposition - Asset Purchase Agreement with EPI Health, LLC In October 2019, the Company entered into an asset purchase agreement with EPI Health pursuant to which the Company sold the worldwide rights to RHOFADE, which included the assignment of certain licenses for related intellectual property assets (the “Disposition”). Pursuant to the asset purchase agreement , EPI Health paid the Company an upfront payment of $35,000 ($1,750 of which was placed in escrow) and $200 for inventory. In addition, EPI Health has agreed to pay the Company (i) potential sales milestone payments of up to $20,000 in the aggregate upon the achievement of specified levels of net sales of products as defined in the asset purchase agreement, (ii) a specified high single-digit royalty calculated as a percentage of net sales, on a product-by-product and country-by-country basis, until the date that the patent rights related to a particular product, such as RHOFADE, have expired, provided, that with respect to sales of RHOFADE in any territory outside of the United States, such royalty shall be paid until the date that the RHOFADE patent rights in the particular country have expired or, if later, 10 years from the date of the first commercial sale of RHOFADE in such country and (iii) 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health in connection with any license or sublicense of the assets transferred in the Disposition in any territory outside of the United States, subject to specified exceptions. Finally, EPI Health agreed to assume the Company’s obligation to pay specified royalties and milestone payments under its existing agreements with Allergan Sales, LLC (“Allergan”), Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. Acquisition – Asset Purchase Agreement with Allergan Sales, LLC In November 2018, the Company acquired the worldwide rights to RHOFADE, which included an exclusive license to certain intellectual property, from Allergan pursuant to an asset purchase agreement. The Company paid Allergan upfront cash consideration of $66,100. In addition, the Company agreed to pay Allergan specified royalties, ranging from a mid-single digit percentage to a mid-teen percentage of net sales, subject to specified reductions, limitations and other adjustments, on a country-by-country basis until the date that the patent rights related RHOFADE have expired or, if later, November 30, 2028. The Company also agreed to assume the obligation to pay specified royalties and milestone payments under agreements with Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. The acquisition of RHOFADE was accounted for as an asset acquisition in accordance with FASB ASC 805-50, rather than as a business combination. As an asset acquisition, the cost to acquire a group of assets is allocated to the individual assets acquired or liabilities assumed based on their relative fair values. The relative fair values of identifiable tangible and intangible assets assumed from the acquisition of RHOFADE were based on estimates of fair value using assumptions that the Company believes were reasonable. The Company accounted for the acquisition of RHOFADE as an asset acquisition because substantially all of the fair value of the assets acquired was concentrated in a single asset, the RHOFADE product rights. ASC 805-10-55-5A, which sets forth a screen test, provides that if substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the assets acquired are not considered to be a business. The following table summarizes the fair value of assets acquired in the acquisition of RHOFADE: Inventory $ 893 Intangible assets, net 66,229 Total assets acquired $ 67,122 The fair value of finished goods inventory acquired was estimated using net selling price less the costs of disposal and a reasonable profit for the disposal efforts. Raw material was valued at current replacement cost, which approximated the seller’s carrying value. The intangible asset for the RHOFADE product rights was being amortized on a straight-line basis over a period of 10 years. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value of Financial Assets and Liabilities | |
Fair Value of Financial Assets and Liabilities | 4. Fair Value of Financial Assets and Liabilities The following tables present information about the fair value measurements of the Company’s financial assets and liabilities which are measured at fair value on a recurring basis, and indicate the level of the fair value hierarchy utilized to determine such fair values: December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 21,277 $ — $ — $ 21,277 Marketable securities — 39,078 — 39,078 Total assets $ 21,277 $ 39,078 $ — $ 60,355 Liabilities: Acquisition-related contingent consideration $ — $ — $ 1,668 $ 1,668 Total liabilities $ — $ — $ 1,668 $ 1,668 December 31, 2018 Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 49,766 $ 4,992 $ — $ 54,758 Marketable securities — 110,953 — 110,953 Total assets $ 49,766 $ 115,945 $ — $ 165,711 Liabilities: Acquisition-related contingent consideration $ — $ — $ 934 $ 934 Total liabilities $ — $ — $ 934 $ 934 As of December 31, 2019 and 2018, the Company’s cash equivalents consisted of investments with maturities of less than three months and included a money market fund and commercial paper, which were valued based upon Level 1 inputs. As of December 31, 2019 and 2018, the Company’s marketable securities consisted of investments with maturities of more than three months and included commercial paper, corporate debt and government obligations, which were valued based upon Level 2 inputs. In determining the fair value of its Level 2 investments, the Company relied on quoted prices for identical securities in markets that are not active. These quoted prices were obtained by the Company with the assistance of a third‑party pricing service based on available trade, bid and other observable market data for identical securities. Quarterly, the Company compares the quoted prices obtained from the third‑party pricing service to other available independent pricing information to validate the reasonableness of the quoted prices provided. The Company evaluates whether adjustments to third-party pricing is necessary and, historically, the Company has not made adjustments to quoted prices obtained from the third-party pricing service. During the years ended December 31, 2019 and 2018, there were no transfers between Level 1, Level 2 and Level 3. The change in acquisition-related contingent consideration of $734 during the year ended December 31, 2019 was the result of updates to the Company’s assumptions as a result of the filing of an Investigational New Drug Application (“IND”) for ATI-450 during the year ended December 31, 2019. As of December 31, 2019 and 2018, the fair value of the Company’s available-for-sale marketable securities by type of security was as follows: December 31, 2019 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ 7,815 $ 2 $ — $ 7,817 Commercial paper 15,129 — — 15,129 Asset-backed securities 8,004 4 — 8,008 U.S. government agency debt securities 8,126 1 (3) 8,124 Total marketable securities $ 39,074 $ 7 $ (3) $ 39,078 December 31, 2018 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ 5,030 $ — $ (14) $ 5,016 Commercial paper 67,159 — — 67,159 Asset-backed securities 21,745 — (8) 21,737 U.S. government agency debt securities 17,044 — (3) 17,041 Total marketable securities $ 110,978 $ — $ (25) $ 110,953 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment, Net | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consisted of the following: December 31, December 31, 2019 2018 Computer equipment $ 1,315 $ 1,292 Finance lease right-of-use assets 435 — Manufacturing equipment — 604 Lab equipment 1,250 1,068 Furniture and fixtures 647 313 Leasehold improvements 889 332 Property and equipment, gross 4,536 3,609 Accumulated depreciation (2,066) (1,322) Property and equipment, net $ 2,470 $ 2,287 Depreciation expense was $1,511, $1,248 and $370 for the years ended December 31, 2019, 2018 and 2017, respectively. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2019 | |
Intangible Assets | |
Intangible Assets | 6. Intangible Assets Intangible assets consisted of the following: Gross Cost Accumulated Amortization Remaining December 31, December 31, December 31, December 31, Life (years) 2019 2018 2019 2018 Other intangible assets 7.6 751 751 181 106 Total definite-lived intangible assets 751 751 181 106 IPR&D na 6,629 6,629 — — Total intangible assets $ 7,380 $ 7,380 $ 181 $ 106 Amortization expense was $75, $75 and $31 for the years ended December 31, 2019, 2018 and 2017 respectively. As of December 31, 2019, estimated future amortization expense is as follows: Year Ending December 31, 2020 $ 75 2021 75 2022 75 2023 75 2024 75 Thereafter 195 Total $ 570 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consisted of the following: December 31, December 31, 2019 2018 Employee compensation expenses $ 3,321 $ 4,948 Research and development expenses 2,857 1,437 Professional fees 168 1,123 Other 1,375 580 Total accrued expenses $ 7,721 $ 8,088 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt | |
Debt | 8. Debt Loan and Security Agreement – Oxford Finance LLC In October 2018, the Company entered into a Loan and Security Agreement (“Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company (“Oxford”). The Loan Agreement provided for up to $65,000 in term loans (the “Term Loan Facility”). Of the $65,000, the Company borrowed $30,000 in October 2018. In October 2019, the Company repaid in full the $30,000 that was outstanding under the Loan Agreement, together with all accrued and unpaid interest and fees. The Loan Agreement provided for interest only payments through November 2021, followed by 24 consecutive equal monthly payments of principal and interest in arrears starting on November 2021 and continuing through the maturity date of October 2023. The Loan Agreement provided for an annual interest rate equal to the greater of (i) 8.35% and (ii) the 30-day U.S. LIBOR rate plus 6.25%. The Loan Agreement also provided for a final payment fee equal to 5.75% of the original principal amount of the term loans drawn under the Term Loan Facility. The carrying value of the Loan Agreement approximated fair value because the interest rate was a floating rate based on the 30-day U.S. LIBOR rate and was therefore reflective of market rates. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 9. Stockholders’ Equity Preferred Stock As of December 31, 2019 and 2018, the Company’s amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of undesignated preferred stock. There were no shares of preferred stock outstanding as of December 31, 2019 and 2018. Common Stock As of December 31, 2019 and 2018, the Company’s amended and restated certificate of incorporation authorized the Company to issue 100,000,000 shares of $0.00001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to any preferential dividend rights of any series of preferred stock that may be outstanding. No dividends have been declared through December 31, 2019. At-The-Market Facility In November 2016, the Company entered into a sales agreement with Cowen and Company, LLC (“Cowen”), pursuant to which Cowen acted as an agent in connection with sales of the Company’s common stock from time to time under an “at-the-market” equity facility. In April 2017, the Company sold 635,000 shares of common stock at a weighted average price per share of $31.50, for aggregate gross proceeds of $20,003. The Company incurred expenses of $691 in connection with the shares issued under the at-the-market sales agreement. In October 2018, the Company terminated the at-the-market sales agreement with Cowen without having sold any additional shares of common stock. August 2017 Public Offering In August 2017, the Company entered into an underwriting agreement pursuant to which the Company issued and sold 3,747,602 shares of common stock under a registration statement on Form S-3, including the underwriters’ partial exercise of their option to purchase additional shares. The shares of common stock were sold to the public at a price of $23.02 per share, for gross proceeds of $86,270. The Company paid underwriting discounts and commissions of $5,176 to the underwriters in connection with the offering. In addition, the Company incurred expenses of $176 in connection with the offering. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and offering expenses, were $80,918. October 2018 Public Offering In October 2018, the Company entered into an underwriting agreement pursuant to which the Company issued and sold 9,941,750 shares of common stock under registration statements on Form S-3, including the underwriters’ full exercise of their option to purchase additional shares. The shares of common stock were sold to the public at a price of $10.75 per share, for gross proceeds of $106,874. The Company paid underwriting discounts and commissions of $6,412 to the underwriters in connection with the offering. In addition, the Company incurred expenses of $257 in connection with the offering. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and offering expenses, were $100,205. |
Stock-Based Awards
Stock-Based Awards | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Awards | |
Stock-Based Awards | 10. Stock‑Based Awards 2017 Inducement Plan In July 2017, the Company’s board of directors adopted the 2017 Inducement Plan (the “2017 Inducement Plan”). The 2017 Inducement Plan is a non-shareholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The only employees eligible to receive grants of awards under the 2017 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq rules, generally including individuals who were not previously an employee or director of the Company. Under the terms of the 2017 Inducement Plan the Company was permitted to grant up to 1,000,000 shares of common stock pursuant to nonqualified stock options, stock appreciation rights, restricted stock awards, RSUs, and other stock awards. All shares of common stock that were eligible for issuance under the 2017 Inducement Plan after October 1, 2018, including any shares underlying any awards that expire or are otherwise terminated, reacquired to satisfy tax withholding obligations, settled in cash or repurchased by the Company in the future that would have been eligible for re-issuance under the 2017 Inducement Plan, were retired. 2015 Equity Incentive Plan In September 2015, the Company’s board of directors adopted the 2015 Equity Incentive Plan (the “2015 Plan”), and the Company’s stockholders approved the 2015 Plan. The 2015 Plan became effective in connection with the Company’s IPO. Beginning at the time the 2015 Plan became effective, no further grants may be made under the Company’s 2012 Equity Compensation Plan, as amended and restated (the “2012 Plan”). The 2015 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards, cash-based awards and other stock-based awards. The number of shares initially reserved for issuance under the 2015 Plan was 1,643,872 shares of common stock. The number of shares of common stock that may be issued under the 2015 Plan will automatically increase on January 1 of each year ending on January 1, 2025, in an amount equal to the lesser of (i) 4.0% of the shares of the Company’s common stock outstanding on December 31 of the preceding calendar year or (ii) an amount determined by the Company’s board of directors. The shares of common stock underlying any awards that expire, are otherwise terminated, settled in cash or repurchased by the Company under the 2015 Plan and the 2012 Plan will be added back to the shares of common stock available for issuance under the 2015 Plan. As of December 31, 2019, 817,586 shares remained available for grant under the 2015 Plan. As of January 1, 2020, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 1,451,997 shares. 2012 Equity Compensation Plan Upon the 2015 Plan becoming effective, no further grants can be made under the 2012 Plan. The Company granted a total of 1,140,524 stock options under the 2012 Plan, of which 745,735 and 984,761 were outstanding as of December 31, 2019 and 2018, respectively. Stock options granted under the 2012 Plan vest over four years and expire after ten years. As required, the exercise price for the stock options granted under the 2012 Plan was not less than the fair value of common shares as determined by the Company as of the date of grant. Stock Option Valuation The weighted average assumptions the Company used to estimate the fair value of stock options granted during the years ended December 31, 2019, 2018 and 2017 were as follows: Year Ended December 31, 2019 2018 2017 Risk-free interest rate 2.27 % 2.66 % 1.93 % Expected term (in years) 6.2 6.3 6.2 Expected volatility 99.36 % 96.78 % 94.19 % Expected dividend yield 0 % 0 % 0 % The Company recognizes compensation expense for awards over their vesting period. Compensation expense for awards includes the impact of forfeiture in the period when they occur. Stock Options The following table summarizes stock option activity for the years ended December 31, 2019, 2018 and 2017: Weighted Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term Value (in years) Outstanding as of December 31, 2016 2,702,350 $ 18.94 9.05 $ 24,434 Granted 790,100 26.21 Exercised (36,738) 6.40 Forfeited and cancelled (126,955) 22.05 Outstanding as of December 31, 2017 3,328,757 $ 20.69 8.28 $ 19,812 Granted 1,459,800 20.97 Exercised (59,450) 9.70 Forfeited and cancelled (447,026) 24.62 Outstanding as of December 31, 2018 4,282,081 $ 20.53 7.91 $ 2,404 Granted 44,500 5.75 Exercised (142,779) 1.33 Forfeited and cancelled (1,081,581) 23.01 Outstanding as of December 31, 2019 3,102,221 $ 20.33 6.55 $ 148 Options vested and expected to vest as of December 31, 2019 3,102,221 $ 20.33 6.55 $ 148 Options exercisable as of December 31, 2019 2,143,889 (1) $ 19.48 5.93 $ 148 (1) All options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right in the Company’s favor that lapses as the option vests. This amount reflects the number of shares under options that were vested, as opposed to exercisable, as of December 31, 2019. The weighted average grant date fair value of stock options granted during the years ended December 31, 2019, 2018 and 2017 was $4.63, $16.55 and $20.28 per share, respectively. Restricted Stock Units The following table summarizes RSU activity for the years ended December 31, 2019, 2018 and 2017. Weighted Average Grant Date Number Fair Value of Shares Per Share Outstanding as of December 31, 2016 219,614 $ 27.43 Granted 117,883 26.27 Vested (40,705) 26.89 Forfeited and cancelled (13,239) 27.53 Outstanding as of December 31, 2017 283,553 $ 27.02 Granted 552,060 19.03 Vested (140,497) 27.22 Forfeited and cancelled (68,709) 23.65 Outstanding as of December 31, 2018 626,407 $ 20.30 Granted 3,650,942 3.56 Vested (173,444) 21.31 Forfeited and cancelled (510,990) 10.63 Outstanding as of December 31, 2019 3,592,915 $ 4.62 Stock‑Based Compensation Stock‑based compensation expense included in total costs and expenses on the consolidated statement of operations included the following: Year Ended December 31, 2019 2018 2017 Cost of revenue $ 703 $ 766 $ 211 Research and development 5,091 6,480 5,471 Sales and marketing — — — General and administrative 10,288 9,317 6,897 Total stock-based compensation expense $ 16,082 $ 16,563 $ 12,579 As of December 31, 2019, the Company had unrecognized stock‑based compensation expense for stock options and RSUs of $13,150 and $12,195, respectively, which is expected to be recognized over weighted average periods of 1.81 years and 2.35 years, respectively. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2019 | |
Net Loss per Share | |
Net Loss per Share | 11. Net Loss per Share Basic and diluted net loss per share is summarized in the following table: Year Ended December 31, 2019 2018 2017 Numerator: Net loss $ (161,354) $ (132,738) $ (68,523) Denominator: Weighted average shares of common stock outstanding 41,323,921 32,909,762 28,102,386 Net loss per share, basic and diluted $ (3.90) $ (4.03) $ (2.44) The Company’s potentially dilutive securities, which included stock options and RSUs, have been excluded from the computation of diluted net loss per share since the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following table presents potential shares of common stock excluded from the calculation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2019, 2018 and 2017. All share amounts presented in the table below represent the total number outstanding as of December 31 of each year. December 31, 2019 2018 2017 Options to purchase common stock 3,102,221 4,282,081 3,328,757 Restricted stock unit awards 3,592,915 626,407 283,553 Total potential shares of common stock 6,695,136 4,908,488 3,612,310 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Leases | 12. Leases The Company has operating leases for office space and laboratory facilities, and finance leases for its laboratory equipment. As a result of the Company’s decision to actively seek partners for its commercial products (see Note 3), the Company terminated the finance leases for its fleet vehicles and recognized a loss on lease termination of $248 during the year ended December 31, 2019. The components of lease expense were as follows: Year Ended December 31, 2019 Operating lease expense $ 808 Finance Leases: Amortization of right-to-use assets $ 443 Interest expense 87 Total finance lease expenses $ 530 Rent expense was $987, $886 and $946 for the years ended December 31, 2019, 2018 and 2017, respectively, which was recognized on a straight-line basis over the term of the lease. Operating Leases Agreements for Office Space In November 2017, the Company entered into a sublease agreement with Auxilium Pharmaceuticals, LLC (the “Sublandlord”) pursuant to which it subleases 33,019 square feet of office space for its headquarters in Wayne, Pennsylvania. The sublease has a term that runs through October 2023. If for any reason the lease between Chesterbrook Partners, LP (“Landlord”) and Sublandlord is terminated or expires prior to October 2023, the Company’s sublease will automatically terminate. In February 2019, the Company entered into a sublease agreement with a third party for 21,056 square feet of office and laboratory space in St. Louis, Missouri. The lease commenced in June 2019 and has a term that runs through June 2029. Supplemental balance sheet information related to operating leases is as follows: December 31, Operating Leases: 2019 Gross cost $ 5,213 Accumulated amortization (480) Operating lease right-of-use assets $ 4,733 Other current liabilities $ 526 Other liabilities 3,548 Total operating lease liabilities $ 4,074 Finance Leases Laboratory Equipment The Company leases laboratory equipment which is used in its laboratory space in St. Louis, Missouri under two finance lease financing arrangements which the Company entered into in August 2017 and October 2017. The leases have terms which end in October 2020 and December 2020, respectively. Fleet Vehicles The Company leased automobiles for its sales force and other field-based employees under the terms of a master lease agreement with a third party. The lease term for each automobile began on the date the Company took delivery and continued for a period of four years. The Company returned all leased vehicles during the year ended December 31, 2019. Supplemental balance sheet information related to finance leases is as follows: December 31, Finance Leases: 2019 Property and equipment, gross $ 435 Accumulated depreciation (322) Property and equipment, net $ 113 Other current liabilities $ 111 Other liabilities 21 Total finance lease liabilities $ 132 Supplemental information related to operating and finance leases is as follows: Year Ended December 31, Supplemental Cash Flow Lease Information: 2019 Operating cash flows from operating leases $ 755 Operating cash flows from finance leases 87 Financing cash flows from finance leases 523 Leased assets obtained in exchange for new operating lease liabilities $ 3,060 Weighted-Average Remaining Lease Term (in years): Operating leases Finance leases Weighted-Average Discount Rate: Operating leases % Finance leases % Future minimum lease payments under operating and finance lease agreements are as follows: Operating Finance Year Ending December 31, Leases Leases 2020 $ 909 $ 116 2021 934 — 2022 959 — 2023 877 — 2024 354 — Thereafter 1,670 — Total undiscounted lease payments 5,703 116 Less: unrecognized interest Total lease liability $ 4,074 $ 111 The undiscounted lease payments presented in the table above are consistent with the future minimum lease payments disclosed in the Company’s Annual Report on Form 10-K filed with the SEC on March 18, 2019 under the prior lease guidance, with the exception of the undiscounted lease payments related to leased vehicles, which were returned during the year ended December 31, 2019. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Income Taxes | 13. Income Taxes The Tax Cuts and Jobs Act of 2017 (the “TCJA”) was enacted on December 22, 2017 and became effective January 1, 2018. The TCJA made significant changes to U.S. tax law, including lowering U.S. corporate income tax rates, implementing a territorial tax system, imposing a one-time transition tax on deemed repatriated earnings of foreign subsidiaries and modifying the taxation of other income and expense items. The TCJA reduced the U.S. corporate income tax rate from 35% to 21%, effective January 1, 2018. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under the TCJA, the Company revalued its deferred tax liabilities, net as of December 31, 2017. The impact of revaluation of the deferred tax liabilities, net was $18,507 of income tax expense, which was more than offset by a reduction in the valuation allowance of $20,344 resulting in a net impact of a $1,837 tax benefit. The net tax benefit recorded was primarily the result of tax law changes which impacted the deferred tax liability the Company recorded for IPR&D related to the acquisition of Confluence. Under GAAP, IPR&D is an indefinite-lived intangible that is capitalized on the balance sheet, but which does not have a cost basis under U.S. tax law. The TCJA provided for a one-time transition tax on the deemed repatriation of post-1986 undistributed foreign subsidiary earnings and profits. The Company did not have consolidated accumulated earnings and profits attributable to its foreign subsidiary; accordingly, the Company did not record any income tax expense related to the transition tax. Due to the timing of the enactment of the TCJA, the Staff of the SEC issued SAB 118 which provided a measurement period to report the impact of the TCJA. During the measurement period, provisional amounts for the effects of the law were able to be recorded to the extent a reasonable estimate can be made. To the extent that all information necessary is not available, prepared or analyzed, companies were able to recognize provisional estimated amounts for a period of up to one year following enactment of the TCJA. The Company completed its analysis during the year ended December 31, 2018, and made no adjustments as a result of TCJA under SAB 118. During the years ended December 31, 2019, 2018 and 2017, the Company did not record an income tax benefit for net operating losses incurred in each year due to the uncertainty of realizing a benefit from those items. Loss before income taxes is allocated as follows: Year Ended December 31, 2019 2018 2017 U.S. operations $ (161,192) $ (132,473) $ (63,665) Foreign operations (162) (265) (6,688) Loss before income taxes $ (161,354) $ (132,738) $ (70,353) A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2019 2018 2017 Federal statutory income tax rate (21.0) % (21.0) % (34.0) % State taxes, net of federal benefit (6.6) (3.5) (9.7) Research and development tax credits (1.5) (2.1) (1.1) Permanent differences 3.0 0.8 0.4 Foreign rate differential — — 1.7 Change in deferred tax asset valuation allowance 26.2 25.7 17.4 Impact of U.S. tax reform — — 22.7 Effective income tax rate 0.1 % (0.1) % (2.6) % Deferred tax liabilities, net consisted of the following: December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 90,298 $ 57,426 Capitalized start-up costs 6,904 6,954 Research and development tax credit carryforwards 7,417 5,038 Capitalized research and development expense 4,456 2,843 Stock‑based compensation expense 12,973 9,037 Accrued compensation 588 923 Inventory — 271 Other 618 683 Total deferred tax assets 123,254 83,175 Deferred tax liabilities: Property and equipment (206) (674) Intangible asset (1,741) (1,735) Section 481(a) adjustment — — Other (890) (330) Total deferred tax liabilities (2,837) (2,739) Valuation allowance (120,966) (80,985) Deferred tax liabilities, net $ (549) $ (549) As of December 31, 2019, the Company had federal and state net operating loss (“NOL”) carryforwards of $326,113 and $338,822, respectively, which will begin to expire in 2032. As of December 31, 2019, the Company also had federal research and development tax credit carryforwards of $7,323 which will begin to expire in 2032, and state research and development tax credit carryforwards of $118 which will begin to expire in 2022. The Company also has $1,675 of loss carryforwards in the United Kingdom which can be carried forward indefinitely. Utilization of the NOLs and research and development tax credit carryforwards in the United States may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership changes that may have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has completed an analysis under Section 382 for NOLs generated from July 13, 2012 through December 31, 2018. Although the Company has experienced Section 382 ownership changes since 2012, the Company has concluded that it should have sufficient ability to utilize NOLs accumulated during the periods tested. The Company has not yet determined if a Section 382 ownership change has occurred during the year ended December 31, 2019, or for Confluence prior to the acquisition. In addition, the Company may experience ownership changes in the future as a result of subsequent shifts in its stock ownership, some of which may be outside of the Company’s control. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. The Company considered its history of cumulative net losses incurred since inception, its lack of substantial revenue generated to date, and its forecasted future operating losses and concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2019 and 2018. The Company evaluates positive and negative evidence of its ability to realize deferred tax assets at each reporting period. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2019, 2018 and 2017 related primarily to the increases in NOLs, capitalized start-up costs, and research and development tax credit carryforwards and were as follows: Year Ended December 31, 2019 2018 2017 Valuation allowance at beginning of year $ (80,985) $ (46,878) $ (30,726) Decreases recorded as benefit to income tax provision — — — Increases resulting from the acquisition of Confluence — — (4,176) Increases recorded to income tax provision (39,981) (34,107) (11,976) Valuation allowance as of end of year $ (120,966) $ (80,985) $ (46,878) During the year ended December 31, 2017, the Company recorded uncertain tax benefits related to tax positions from the acquired Confluence business, which were settled during the year ended December 31, 2018. The following table summarizes the changes in the Company’s unrecognized tax benefits: Year ended December 31, 2019 2018 2017 Unrecognized tax benefits at beginning of year $ — $ 43 $ — Increases related to prior year tax provisions — 43 Decreases related to prior year tax provisions — (43) — Increases related to current year tax provisions — — — Unrecognized tax benefits as of end of year $ — $ — $ 43 The total amount of unrecognized tax benefits that, if recognized, would impact the Company’s effective tax rate were $0 as of December 31, 2019 and 2018. The Company accrues interest and penalties related to unrecognized tax benefits in income tax expense (benefit) in the consolidated statement of operations and comprehensive loss. During each of the years ended December 31, 2019, 2018 and 2017, the Company recognized expense (benefit) of $0, $0 and $3, respectively, related to interest and penalties. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2012 to the present. All open years may be examined to the extent that tax credit or NOLs are used in future periods. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions | |
Related Party Transactions | 14. Related Party Transactions NeXeption, Inc. In August 2013, the Company entered into a sublease agreement with NeXeption, Inc. ("NeXeption"), which was subsequently assigned to NST Consulting, LLC, a wholly-owned subsidiary of NST, LLC. In November 2017, the Company terminated the sublease with NST Consulting, LLC effective March 31, 2018. The Company paid $590 to NST Consulting, LLC, which amount represented accelerated rent payments. The Company recorded a one-time charge of $506 in the year ended December 31, 2017 which is included in general and administrative expenses in the consolidated statement of operations. Total payments made under the sublease during the years ended December 31, 2019, 2018 and 2017, were $0, $570 and $318, respectively. In February 2014, the Company entered into a services agreement with NST, LLC (the “NST Services Agreement”), pursuant to which NST, LLC provided certain pharmaceutical development, management and other administrative services to the Company. The NST Services agreement was subsequently assigned by NST, LLC to NST Consulting, LLC. Under the same agreement the Company also provided services to another company under common control with the Company and NST Consulting, LLC and was reimbursed by NST, LLC for those services. In November 2017, the Company terminated the NST Services Agreement effective December 31, 2017. During the years ended December 31, 2019, 2018 and 2017, the Company incurred $0, $0 and $208 of net expenses for services provided by NST Consulting, LLC under the NST Services Agreement. The Company had no amounts payable to NST Consulting, LLC under the NST Services Agreement as of either December 31, 2019 or 2018. Mr. Stephen Tullman, the former chairman of the Company’s board of directors, is an executive officer of NeXeption and is also the manager of NST Consulting, LLC and NST, LLC, and certain of the Company’s executive officers are and have been members of entities affiliated with NST, LLC. Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. In November 2018, the Company acquired RHOFADE, including an exclusive license to certain intellectual property for RHOFADE as well as additional intellectual property, from Allergan pursuant to the terms of an asset purchase agreement. Pursuant to the asset purchase agreement, the Company agreed to assume the obligation to pay specified royalties and milestone payments under agreements with Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. Certain current and former members of the Company’s management team and board of directors are former holders of equity interests in Vicept Therapeutics, Inc. and Aspect Pharmaceuticals, LLC . In such capacities, these individuals may have been entitled to receive a portion of the potential future payments payable by the Company. In October 2019, the Company sold the worldwide rights to RHOFADE to EPI Health, who agreed to assume the Company’s obligation to pay the royalties and milestone payments under its existing agreements with Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. The Company incurred an aggregate expense of $611, $51 and $0 related to royalty payments under these agreements during the years ended December 31, 2019, 2018 and 2017, respectively (see Note 3). Mallinckrodt plc In April 2018, Bryan Reasons was appointed to the Company’s board of directors. Subsequently, in March 2019, Mr. Reasons became the Chief Financial Officer of Mallinckrodt plc. Prior to Mr. Reasons joining Mallinckrodt plc, the Company entered into a master services agreement with Mallinckrodt, LLC, a subsidiary of Mallinckrodt plc, in November 2018, pursuant to which Confluence provides laboratory services to Mallinckrodt in the ordinary course of business. Mr. Reasons was not involved in the negotiation or execution of the agreement, but may be deemed to have an interest in the ongoing transactions based on his employment as an executive officer of Mallinckrodt plc. During the years ended December 31, 2019 and 2018, the Company recorded revenue of $97 and $0, respectively, from Mallinckrodt under the master services agreement. Mr. Reasons had no financial interest in this transaction. |
Agreements Related to Intellect
Agreements Related to Intellectual Property | 12 Months Ended |
Dec. 31, 2019 | |
Agreements Related to Intellectual Property | |
Agreements Related to Intellectual Property | 15. Agreements Related to Intellectual Property Asset Purchase Agreement – Allergan Sales, LLC In November 2018, the Company acquired RHOFADE from Allergan pursuant to an asset purchase agreement. The Company agreed to pay Allergan specified royalties, ranging from a mid-single digit percentage to a mid-teen percentage of net sales, subject to specified reductions, limitations and other adjustments, on a country-by-country basis until the date that the patent rights related to RHOFADE have expired or, if later, November 30, 2028. The Company incurred royalties earned by Allergan under the asset purchase agreement of $1,359 , $114 and $0 during the years ended December 31, 2019, 2018 and 2017, respectively. The Company also agreed to pay Allergan a one-time payment of $5,000 upon the achievement of a specified development milestone related to the potential development of an additional dermatology product. In October 2019, the Company sold the worldwide rights to RHOFADE to EPI Health, which agreed to assume the obligation to pay the royalties and milestone payments under the asset purchase agreement (see Note 3). Agreement and Plan of Merger - Confluence In August 2017, the Company entered into an Agreement and Plan of Merger, pursuant to which it acquired Confluence (the “Confluence Agreement”). In November 2018, the Company achieved a development milestone specified in the Confluence Agreement which was comprised of $2,500 in cash and 253,208 shares of its common stock with a fair value of $2,200. The Company also agreed to pay the former Confluence equity holders aggregate remaining contingent consideration of up to $75,000, based upon the achievement of specified regulatory and commercial milestones set forth in the Confluence Agreement. In addition, the Company agreed to pay the former Confluence equity holders future royalty payments calculated as a low single-digit percentage of annual net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. In addition, if the Company sells, licenses or transfers any of the intellectual property acquired from Confluence pursuant to the Confluence Agreement to a third party, the Company will be obligated to pay the former Confluence equity holders a portion of any incremental consideration (in excess of the development and milestone payments described above) received from such sale, license or transfer in specified circumstances. License and Collaboration Agreement – Rigel Pharmaceuticals, Inc. In August 2015, the Company entered into an exclusive, worldwide license and collaboration agreement with Rigel Pharmaceuticals, Inc. (“Rigel”) for the development and commercialization of products containing two specified JAK inhibitors, which the Company refers to as ATI-501 and ATI-502. Under the agreement, the Company agreed to make aggregate payments of up to $80,000 upon the achievement of specified development milestones. During the year ended December 31, 2019, the Company made a milestone payment of $4,000 to Rigel upon the achievement of a specified development milestone which is included in research and development expenses on the Company’s consolidated statement of operations. With respect to any products the Company commercializes under the agreement, the Company will pay Rigel quarterly tiered royalties on its annual net sales of each product at a high single‑digit percentage of annual net sales, subject to specified reductions, until the date that all of the patent rights for that product have expired, as determined on a country‑by‑country and product‑by‑product basis or, in specified countries under specified circumstances, ten years from the first commercial sale of such product. In connection with the amendment of the agreement in October 2019, the Company agreed to pay Rigel an amendment fee of $1,500 in three installments of $500 in January 2020, April 2020 and July 2020, which is included in accrued expenses on the Company’s consolidated balance sheet as of December 31, 2019. In addition, the parties modified certain other development milestones, and the Company agreed to increase the potential payments payable upon the achievement of such milestones from $10,000 to $10,500 in the aggregate. License, Development and Commercialization Agreement - Cipher Pharmaceuticals Inc. In April 2018, the Company entered into an exclusive license agreement with Cipher Pharmaceuticals Inc. (“Cipher”) for the rights to obtain regulatory approval of and commercialize A-101 40% Topical Solution , which the Company marketed under the brand name ESKATA in the United States, in Canada for the treatment of seborrheic keratosis . The Company received an upfront payment of $1,000 upon signing of the agreement with Cipher and $500 upon the achievement of a specified regulatory milestone, both of which are included in other revenue in the Company’s consolidated statement of operations for the year ended December 31, 2018. In September 2019, the Company and Cipher mutually terminated the exclusive license agreement. Assignment Agreement - Estate of Mickey Miller and Finder’s Services Agreement - KPT Consulting, LLC In August 2012, the Company entered into an assignment agreement with the Estate of Mickey Miller (the “Miller Estate”) under which the Company acquired some of the intellectual property rights covering A-101 45% Topical Solution and ESKATA. In connection with obtaining the assignment of the intellectual property from the Miller Estate, the Company also entered into a separate finder’s services agreement with KPT Consulting, LLC. Under the terms of the finder’s services agreement, the Company made a milestone payment of $1,000 upon the achievement of a specified regulatory milestone in April 2017, and a milestone payment of $1,500 upon the achievement of a specified commercial milestone in May 2018. The payments were recorded as general and administrative expenses in the Company’s consolidated statement of operations. Under the finder’s services agreement the Company is obligated to make an additional milestone payment of $3,000 upon the achievement of a specified commercial milestone. Under each of the assignment agreement and the finder’s services agreement, the Company is obligated to pay royalties on sales of ESKATA and any related products, at low single-digit percentages of net sales, subject to reduction in specified circumstances. The Company incurred an aggregate expense of $14, $112 and $0 related to royalty payments under these agreements during the years ended December 31, 2019, 2018 and 2017, respectively. Both agreements will terminate upon the expiration of the last pending, viable patent claim of the patents acquired under the assignment agreement, but no sooner than 15 years from the effective date of the agreements. Stock Purchase Agreement - Vixen Pharmaceuticals, Inc. and License Agreement - Columbia University In March 2016, the Company entered into a stock purchase agreement (the “Vixen Agreement”) with Vixen, JAK1, LLC, JAK2, LLC and JAK3, LLC (together, the “Selling Stockholders”) and Shareholder Representative Services LLC, solely in its capacity as the representative of the Selling Stockholders. Pursuant to the Vixen Agreement, the Company acquired all shares of Vixen’s capital stock from the Selling Stockholders. Following the acquisition of Vixen, Vixen became a wholly-owned subsidiary of the Company. The Company is obligated to make annual payments of $100 each year through March 2022, with such amounts being creditable against specified future payments that may be paid under the Vixen Agreement. The Company is obligated to make aggregate payments of up to $18,000 to the Selling Stockholders upon the achievement of specified pre-commercialization milestones for three products covered by the Vixen patent rights in the United States, the European Union and Japan, and aggregate payments of up to $22,500 upon the achievement of specified commercial milestones for products covered by the Vixen patent rights. With respect to any covered products that the Company commercializes under the Vixen Agreement, the Company is obligated to pay low single-digit royalties on net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. If the Company sublicenses any of Vixen’s patent rights and know-how acquired pursuant to the Vixen Agreement, the Company will be obligated to pay a portion of any consideration the Company receives from such sublicenses in specified circumstances. As a result of the transaction with Vixen, the Company became party to the Exclusive License Agreement, by and between Vixen and the Trustees of Columbia University in the City of New York (“Columbia”), dated as of December 31, 2015 (as amended, the “License Agreement”). Under the License Agreement, the Company is obligated to pay Columbia an annual license fee of $10, subject to specified adjustments for patent expenses incurred by Columbia and creditable against any royalties that may be paid under the License Agreement. The Company is also obligated to pay up to an aggregate of $11,600 upon the achievement of specified commercial milestones, including specified levels of net sales of products covered by Columbia patent rights and/or know-how, and royalties at a sub-single-digit percentage of annual net sales of products covered by Columbia patent rights and/or know-how, subject to specified adjustments. If the Company sublicenses any of Columbia’s patent rights and know-how acquired pursuant to the License Agreement, it will be obligated to pay Columbia a portion of any consideration received from such sublicenses in specified circumstances. The royalties, as determined on a country-by-country and product-by-product basis, are payable until the date that all of the patent rights for that product have expired, the expiration of any market exclusivity period granted by a regulatory body or, in specified circumstances, ten years from the first commercial sale of such product. The License Agreement terminates on the date of expiration of all royalty obligations thereunder unless earlier terminated by either party for a material breach, subject to a specified cure period. The Company may also terminate the License Agreement without cause at any time upon advance written notice to Columbia. |
Retirement Savings Plan
Retirement Savings Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Savings Plan | |
Retirement Savings Plan | 16. Retirement Savings Plan The Company has a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the Company’s board of directors. The Company has elected to match 100% of employee contributions to the 401(k) Plan up to 4% of the employee’s earnings, subject to certain limitations. Company contributions under the 401(k) Plan were $740, $662, and $270 for the years ended December 31, 2019, 2018 and 2017, respectively. |
Restructuring Charges
Restructuring Charges | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring Charges | |
Restructuring Charges | 17. Restructuring Charges In September 2019, the Company announced the completion of a strategic review and its decision to refocus on its immuno-inflammatory development programs and to actively seek partners for its commercial products. As a result, the Company terminated 63 employees (“terminated employees”) and gave notice to an additional 23 employees (“noticed employees”) who were asked to provide transition services through termination dates ranging between 4 to 10 months from the date notice was given. The terminated employees were entitled to receive cash severance payments as well as cash payments in lieu of sixty days’ notice required by the Worker Adjustment and Retraining Notification Act (the “WARN Act”). The noticed employees are entitled to receive one-time cash severance payments which are not contingent upon providing additional services to the Company. In addition, certain noticed employees can earn retention bonuses if they continue to be employed by the Company through certain termination dates. The Company recorded a restructuring charge for the one-time severance and WARN Act payments, which was triggered immediately upon either terminating or giving notice to the impacted employees. The Company is expensing the cost of retention bonuses for noticed employees over their respective service terms. During the year ended December 31, 2019, the Company recognized aggregate expenses of $2,748 and made payments of $2,316 related to termination benefits for employees explained above. The Company committed to paying up to $339 for contingent retention bonuses, of which $208 was accrued, as of December 31, 2019. |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2019 | |
Discontinued Operations | |
Discontinued Operations | 18. Discontinued Operations The components of loss from discontinued operations as reported in the Company’s consolidated statement of operations were as follows: Year Ended December 31, 2019 2018 2017 Revenues: Product sales, net $ 13,896 $ 3,940 $ — Total revenue, net 13,896 3,940 — Costs and expenses: Cost of revenue (excludes amortization) 4,522 1,969 — Research and development 503 2,168 3,986 Sales and marketing 23,112 47,827 13,684 General and administrative 2,929 2,058 392 Intangible asset impairment 27,638 — — Amortization of definite-lived intangible 4,426 552 — Total costs and expenses 63,130 54,574 18,062 Loss from discontinued operations (49,234) (50,634) (18,062) Other income, net 1,422 — — Net loss from discontinued operations $ (47,812) $ (50,634) $ (18,062) Net loss from discontinued operations per share, basic and diluted $ (1.16) $ (1.54) $ (0.64) Weighted average common shares outstanding, basic and diluted 41,323,921 32,909,762 28,102,386 The following table presents the details of product sales, net included in discontinued operations: Year Ended December 31, 2019 2018 2017 ESKATA $ 312 $ 2,804 $ — RHOFADE 13,584 1,136 — Total product sales, net $ 13,896 $ 3,940 $ — The following table presents information related to assets and liabilities reported as discontinued operations in the Company’s consolidated balance sheet: December 31, 2019 2018 Accounts receivable, net $ 4,966 $ 4,298 Inventory — 791 Prepaid expenses and other current assets — 1,073 Intangible asset held for sale — — Discontinued operations - current assets $ 4,966 $ 6,162 Property and equipment, net $ — $ 1,993 Intangible assets, net of accumulated amortization — 65,677 Discontinued operations - non-current assets $ — $ 67,670 Accounts payable $ 1,705 $ 3,080 Accrued expenses 2,452 3,898 Current portion of lease liabilities — 459 Discontinued operations - current liabilities $ 4,157 $ 7,437 Other liabilities $ — $ 1,227 Discontinued operations - non- current liabilities $ — $ 1,227 The following table presents certain non-cash items related to discontinued operations, which are included in the Company’s consolidated statement of cash flows: Year Ended December 31, 2019 2018 Depreciation and amortization $ 313 $ 269 Stock-based compensation expense Intangible asset impairment charge 27,638 — Loss on disposal of property and equipment 248 — 28,294 3,759 Gain on sale of RHOFADE 1,670 — Non-cash items, net $ 26,624 $ 3,759 The Company relied on Allergan to distribute RHOFADE on its behalf pursuant to the terms of a transition services agreement. Accounts receivable, net as of December 31, 2019 and 2018 included $4,966 and $3,838, respectively, related to amounts invoiced by Allergan for sales of RHOFADE. As a result of the Company’s decision to actively seek partners for its commercial products, the Company terminated the finance leases for its fleet vehicles and recognized a loss on lease termination of $248 in the year ended December 31, 2019, which is included in other income, net in the Company’s consolidated statement of operations. During the year ended December 31, 2019, the Company performed an impairment analysis of the RHOFADE intangible asset due to its decision to discontinue commercial operations and actively seek a commercialization partner for RHOFADE. The Company’s impairment analysis, which primarily utilized a third-party indication of fair value, resulted in a fair value for the RHOFADE intangible asset which was less than its carrying value. As a result, the Company recorded an impairment charge of $27,638 to adjust the carrying value of the RHOFADE intangible asset to its net realizable value. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2019 | |
Segment Information | |
Segment Information | 19. Segment Information The Company has two reportable segments, therapeutics and contract research. The therapeutics segment is focused on identifying and developing innovative therapies to address significant unmet needs for immuno-inflammatory diseases. The contract research segment earns revenue from the provision of laboratory services to clients through Confluence, the Company’s wholly-owned subsidiary. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis. Corporate and other includes general and administrative expenses as well as eliminations of intercompany transactions. The Company does not report balance sheet information by segment since it is not reviewed by the chief operating decision maker, and all of the Company’s tangible assets are held in the United States. The Company’s results of operations by segment for the years ended December 31, 2019, 2018 and 2017 are summarized in the tables below: Contract Corporate Total Year Ended December 31, 2019 Therapeutics Research and Other Company Revenue, net $ — $ 16,824 $ (12,597) $ 4,227 Cost of revenue (excludes amortization) — 16,253 (12,198) 4,055 Research and development 65,298 — (399) 64,899 Sales and marketing 620 51 — 671 General and administrative — 2,687 24,469 27,156 Goodwill impairment 18,504 — — 18,504 Loss from operations $ (84,422) $ (2,167) $ (24,469) $ (111,058) Loss from discontinued operations $ (46,305) $ — $ (2,929) $ (49,234) Contract Corporate Total Year Ended December 31, 2018 Therapeutics Research and Other Company Revenue, net $ 1,500 $ 13,135 $ (8,484) $ 6,151 Cost of revenue — 11,399 (7,070) 4,329 Research and development 62,255 — (1,414) 60,841 Sales and marketing 130 40 — 170 General and administrative 30 2,141 23,420 25,591 Loss from operations $ (60,915) $ (445) $ (23,420) $ (84,780) Loss from discontinued operations $ (48,576) $ — $ (2,058) $ (50,634) Contract Corporate Total Year Ended December 31, 2017 Therapeutics Research and Other Company Revenue, net $ — $ 3,202 $ (1,519) $ 1,683 Cost of revenue — 2,726 (1,519) 1,207 Research and development 35,804 — — 35,804 Sales and marketing 85 — — 85 General and administrative 222 673 18,053 18,948 Loss from operations $ (36,111) $ (197) $ (18,053) $ (54,361) Loss from discontinued operations $ (17,670) $ — $ (392) $ (18,062) Intersegment Revenue Revenue for the contract research segment included $12,597, $8,484 and $1,519 for services performed on behalf of the therapeutics segment for the years ended December 31, 2019, 2018 and 2017, respectively. All intersegment revenue has been eliminated in the Company’s consolidated statement of operations. |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2019 | |
Legal Proceedings | |
Legal Proceedings | 20. Legal Proceedings Securities Class Action On July 30, 2019, plaintiff Linda Rosi (“Rosi”) filed a putative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al. in the U.S. District Court for the Southern District of New York against the Company and certain of its executive officers. The complaint alleges that the defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA and find that the materials minimized the risks or overstated the efficacy of the product. The complaint seeks unspecified compensatory damages on behalf of Rosi and all other persons and entities that purchased or otherwise acquired the Company’s securities between May 8, 2018 and June 20, 2019. On September 5, 2019, an additional plaintiff, Robert Fulcher (“Fulcher”), filed a substantially identical putative class action complaint captioned Fulcher v. Aclaris Therapeutics, Inc., et al. in the same court against the same defendants. On November 6, 2019, the court consolidated the Rosi and Fulcher actions (together, the “Consolidated Securities Action”) and appointed Fulcher “lead plaintiff” for the putative class. On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming two additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness. The defendants’ deadline to answer, move against or otherwise respond to the consolidated amended complaint is March 27, 2020. The Company and the other defendants dispute plaintiffs’ claims in the Consolidated Securities Action and intend to defend the matter vigorously. Stockholder Derivative Action On November 15, 2019, plaintiff Keith Allred (“Allred”) filed a derivative stockholder complaint captioned Allred v. Walker et al. in the U.S. District Court for the Southern District of New York against certain of the Company’s directors and executive officers. The complaint alleges that the defendants, among other things, breached their fiduciary duties as directors and/or officers in connection with the claims alleged in the Consolidated Securities Action. The complaint seeks, among other things, unspecified compensatory damages on behalf of the Company. On November 25, 2019, an additional plaintiff, Bruce Brown (“Brown”), filed a substantially identical complaint captioned Brown v. Walker et al. in the same court against the same defendants. On December 12, 2019, the court consolidated the Allred and Brown actions under the caption In re Aclaris Therapeutics, Inc. Derivative Litigation (the “Consolidated Derivative Action”) and directed that future derivative cases filed in or transferred to the court arising out of substantially the same transactions or events be similarly consolidated. Thereafter, on January 11, 2020, the court stayed – subject to certain conditions – all deadlines in the Consolidated Derivative Action pending resolution of the defendants’ anticipated motion to dismiss the Consolidated Securities Action. The defendants dispute plaintiffs’ claims in the Consolidated Derivative Action and intend to defend the matter vigorously. Patent Infringement On October 8, 2019, the Company, together with Allergan, Inc., filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Taro Pharmaceuticals, Inc. (“Taro”), related to an Abbreviated New Drug Application (“ANDA”) that Taro filed with the FDA to market a generic version of RHOFADE. The lawsuit claims infringement of U.S. Patent Nos. 7,812,049, 8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for RHOFADE. The Company received a Paragraph IV Notice Letter from Taro dated August 28, 2019, advising that Taro had submitted an ANDA to the FDA seeking approval from the FDA to manufacture and market a generic version of RHOFADE prior to the expiration of the Orange Book-listed patents. Under the agreement with EPI Health for the purchase of RHOFADE, EPI Health agreed to file a motion to be substituted for the Company as a plaintiff party and has agreed to reimburse the Company for its reasonable fees and expenses so long as it remained a plaintiff party. On December 3, 2019, EPI Health was substituted for the Company as a plaintiff party. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly-owned subsidiaries, Confluence, ATIL and Vixen. All significant intercompany transactions have been eliminated. Based upon the revenue from contract research services, the Company believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the consolidated statement of operations. |
Discontinued Operations | Discontinued Operations In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products. The Company also announced a plan to terminate 86 employees (see Note 17). The accompanying consolidated financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to the Company’s commercial products as discontinued operations (see Note 18). The accompanying consolidated financial statements are generally presented in conformity with the Company’s historical format, even in certain situations where reclassifications to discontinued operations have resulted in $0 values being presented. The Company believes this format provides comparability with its previously filed financial statements. |
Use of Estimates | 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 and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, research and development expenses, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. |
Revenue Recognition | Revenue Recognition The Company accounts for revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable. Product Sales, net The Company sold RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) and ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w) (“ESKATA”) during the years ended December 31, 2019 and 2018 to a limited number of wholesalers in the United States (collectively, its “Customers”). These Customers subsequently resold the Company’s products to pharmacies and health care providers. In addition to distribution agreements with Customers, the Company entered into, or was subject to, arrangements with third-party payors, including pharmacy benefit managers and government agencies, as well as group purchasing organizations (“GPOs”), which provided for government mandated or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s commercial products. The Company discontinued selling ESKATA in August 2019. The Company sold the worldwide rights to RHOFADE in October 2019 (see Note 3). Product sales, net has been reclassified to discontinued operations for all periods presented. The Company recognized revenue from product sales at the point the Customer obtained control of the product, which generally occurred upon delivery. The Company also included estimates of variable consideration in the same period revenue was recognized. Components of variable consideration include trade discounts and allowances, product returns, government rebates, discounts and rebates, other incentives such as patient co-pay assistance, and other fee for service amounts. Variable consideration was recorded on the consolidated balance sheet as either a reduction of accounts receivable, if payable to a Customer, or as a current liability, if payable to a third party other than a Customer. The Company considered all relevant information when estimating variable consideration such as contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of net revenue that can be recognized is constrained by estimates of variable consideration which are included in the transaction price. Payment terms with Customers did not exceed one year and, therefore, the Company did not account for a financing component in its arrangements. The Company expensed incremental costs of obtaining a contract with a Customer, including sales commissions, when incurred as the period of benefit was less than one year. Trade Discounts and Allowances - The Company provided Customers with trade discounts, rebates, allowances and/or other incentives. The Company recorded estimates for these items as a reduction of revenue in the same period the revenue was recognized. Government and Payor Rebates - The Company contracted with, or was subject to arrangements with, certain third-party payors, including pharmacy benefit managers and government agencies, for the payment of rebates with respect to utilization of its commercial products. The Company also entered into agreements with GPOs that provided for administrative fees and discounted pricing in the form of volume-based rebates. The Company was also subject to discount and rebate obligations under state Medicaid programs and Medicare. The Company recorded estimates for these discounts and rebates as a reduction of revenue in the same period the revenue was recognized. Other Incentives - The Company maintained a co-pay assistance program which was intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by third-party payors. The Company estimated and recorded accruals for these incentives as a reduction of revenue in the period the revenue was recognized. The Company estimated amounts for co-pay assistance based upon the number of claims and the cost per claim that the Company expected to receive associated with product that had been sold to Customers but remained in the distribution channel at the end of each reporting period. Product Returns - Consistent with industry practice, the Company has a product returns policy for RHOFADE that provides Customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The right of return lapses upon shipment of the product to a patient. The Company recorded an estimate for the amount of its products which may be returned as a reduction of revenue in the period the related revenue was recognized. The Company’s estimate for product returns was based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. There is no return liability associated with sales of ESKATA as the Company had a no returns policy for ESKATA when it was commercialized. Contract Research The Company earns contract research revenue from the provision of laboratory services to clients through Confluence, its wholly-owned subsidiary. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis and are generally billed on a monthly basis in arrears for services rendered. Revenue related to these contracts is generally recognized as the laboratory services are performed, based upon the rates specified in the contracts. Under ASC Topic 606, the Company elected to apply the “right to invoice” practical expedient when recognizing contract research revenue. The Company recognizes contract research revenue in the amount to which it has the right to invoice. The Company has also received revenue from grants under the Small Business Innovation Research program of the National Institutes of Health (“NIH”). During the year ended December 31, 2018, the Company had two active grants from NIH which were related to early-stage research. As of December 31, 2019, there were no remaining funds available to the Company under the grants. The Company recognizes revenue related to grants as amounts become reimbursable under each grant, which is generally when research is performed, and the related costs are incurred. Other Revenue Licenses of Intellectual Property – The Company recognizes revenue received from non-refundable, upfront fees related to the licensing of intellectual property when the intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the license has been transferred to the customer, and the customer is able to use and benefit from the license. Milestone Payments – At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the amount allocated to the license of intellectual property. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all short-term, highly liquid investments with original maturities of 90 days or less at acquisition date to be cash equivalents. Cash equivalents, which have consisted of money market accounts, commercial paper and corporate debt securities with original maturities of less than three months, are stated at fair value. Restricted cash as of December 31, 2019 included $1,750 placed in escrow pursuant to the asset purchase agreement with EPI Health, LLC (“EPI Health”) (see Note 3). |
Marketable Securities | Marketable Securities Marketable securities with original maturities of greater than three months and remaining maturities of less than one year from the balance sheet date are classified as short-term. Marketable securities with remaining maturities of greater than one year from the balance sheet date are classified as long-term. The Company classifies all of its marketable securities as available-for-sale securities. The Company’s marketable securities are measured and reported at fair value using quoted prices in markets that are not active for identical or similar securities. Unrealized gains and losses are reported as a separate component of stockholders’ equity. The cost of securities sold is determined on a specific identification basis, and realized gains and losses, if any, are included in other income, net within the consolidated statement of operations and comprehensive loss. If any adjustment to fair value reflects a decline in the value of the investment, the Company considers available evidence to evaluate the extent to which the decline is “other than temporary” and reduces the investment to fair value through a charge to the statement of operations and comprehensive loss. |
Inventory | Inventory Inventory includes the third-party cost of manufacturing and assembly of finished product, quality control and other overhead costs. Inventory is stated at the lower of cost or net realizable value. Inventory is adjusted for short-dated, unmarketable inventory equal to the difference between the cost of inventory and the estimated value based upon assumptions about future demand and market conditions. The Company had $0 and $791 of inventory as of December 31, 2019 and 2018, respectively, which was comprised primarily of finished goods and has been reclassified to discontinued operations for all periods presented. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the useful life of the asset. Computer equipment is depreciated over three years. Manufacturing and laboratory equipment is depreciated over five years. Furniture and fixtures are depreciated over five years. Leasehold improvements are depreciated over the shorter of the lease term or their useful life. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in loss from operations. |
Impairment of Long Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. |
Intangible Assets | Intangible Assets Intangible assets include both definite-lived and indefinite-lived assets. Definite-lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used. Definite-lived intangible assets consist of a research technology platform the Company acquired through the acquisition of Confluence. Prior to the disposition in 2019, definite-lived intangible assets also included the intellectual property rights related to RHOFADE. Indefinite-lived intangible assets consist of an in-process research and development (“IPR&D”) drug candidate acquired through the acquisition of Confluence. IPR&D assets are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. The cost of IPR&D is either amortized over its estimated useful life beginning when the underlying drug candidate is approved and launched commercially, or expensed immediately if development of the drug candidate is abandoned. Definite-lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Indefinite-lived intangible assets are tested for impairment at least annually, which the Company performs during the fourth quarter, or when indicators of an impairment are present. The Company recognizes impairment losses when and to the extent that the estimated fair value of an intangible asset is less than its carrying value. During the year ended December 31, 2019, the Company performed an impairment analysis of the RHOFADE intangible asset due to its decision to discontinue commercial operations and actively seek a commercialization partner for RHOFADE. The Company’s impairment analysis, which primarily utilized a market-participant’s indication of fair value, resulted in a fair value for the RHOFADE intangible asset which was less than its carrying value. As a result, the Company recorded an impairment charge of $27,638, which is included in discontinued operations on the consolidated statement of operations, to adjust the carrying value of the RHOFADE intangible asset to its net realizable value (see Note 3). |
Goodwill | Goodwill Goodwill is not amortized, but rather is subject to testing for impairment at least annually, which the Company performs either during the fourth quarter or when indicators of an impairment are present. The Company considers each of its operating segments, therapeutics and contract research, to be a reporting unit since this is the lowest level for which discrete financial information is available. The Company attributed the full amount of the goodwill acquired with Confluence, or $18,504, to the therapeutics segment. The annual impairment test performed by the Company is a qualitative assessment based upon current facts and circumstances related to operations of the therapeutics segment. If the qualitative assessment indicates an impairment may be present, the Company would perform the required quantitative analysis and an impairment charge would be recognized to the extent that the estimated fair value of the reporting unit is less than its carrying amount. However, any loss recognized would not exceed the total amount of goodwill allocated to that reporting unit. During the year ended December 31, 2019, the Company performed an impairment analysis due to the decline in its stock price, which was considered a triggering event to evaluate goodwill for impairment. The Company’s impairment analysis, using a market approach, noted that its stock price, including a reasonable control premium, resulted in a fair value for the therapeutics reporting unit which was less than its carrying value. As a result, the Company recorded an impairment charge of $18,504, the full balance of goodwill. |
Leases | Leases Leases represent a company’s right to use an underlying asset and a corresponding obligation to make payments to a lessor for the right to use those assets. The Company evaluates leases at their inception to determine if they are an operating lease or a finance lease. A lease is accounted for as a finance lease if it meets one of the following five criteria: the lease has a purchase option that is reasonably certain of being exercised, the present value of the future cash flows are substantially all of the fair market value of the underlying asset, the lease term is for a significant portion of the remaining economic life of the underlying asset, the title to the underlying asset transfers at the end of the lease term, or if the underlying asset is of such a specialized nature that it is expected to have no alternative uses to the lessor at the end of the term. Leases that do not meet the finance lease criteria are accounted for as an operating lease. The Company recognizes assets and liabilities for leases at their inception based upon the present value of all payments due under the lease. The Company uses an implicit interest rate to determine the present value of finance leases, and its incremental borrowing rate to determine the present value of operating leases. The Company determines incremental borrowing rates by referencing collateralized borrowing rates for debt instruments with terms similar to the respective lease. The Company recognizes expense for operating and finance leases on a straight-line basis over the term of each lease, and interest expense related to finance leases is recognized over the lease term based on the effective interest method. The Company includes estimates for any residual value guarantee obligations under its leases in lease liabilities recorded on its consolidated balance sheet. Right-of-use assets are included in other assets and property and equipment, net on the Company’s consolidated balance sheet for operating and finance leases, respectively. Obligations for lease payments are included in current portion of lease liabilities and other liabilities on the Company’s consolidated balance sheet for both operating and finance leases. |
Contingent Consideration | Contingent Consideration The Company initially recorded the contingent consideration related to future potential payments based upon the achievement of certain development, regulatory and commercial milestones, resulting from the acquisition of Confluence, at its estimated fair value on the date of acquisition. Changes in fair value reflect new information about the likelihood of the payment of the contingent consideration and the passage of time. For example, if the timing of the development of an acquired drug candidate, or the size of potential commercial opportunities related to an acquired drug, differ from the Company’s assumptions, then the fair value of contingent consideration would be adjusted accordingly. Future changes in the fair value of the contingent consideration, if any, will be recorded as income or expense in the Company’s consolidated statement of operations. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses include salaries, stock-based compensation and benefits of employees, fees paid under licensing agreements, fees paid under a third party assignment agreement and other operational costs related to the Company’s research and development activities, including depreciation expenses and the cost of research and development contracts which the Company has entered into with outside vendors to conduct both preclinical studies and clinical trials. Significant judgment and estimates are made in determining the amount of research and development costs recognized in each reporting period. The Company analyzes the progress of its preclinical studies and clinical trials, completion of milestone events, invoices received and contracted costs when estimating research and development costs. Actual results could differ from the Company’s estimates. The Company’s historical estimates for research and development costs have not been materially different from the actual costs. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the compensation expense of stock-based awards granted to employees and directors using the grant date fair value of the award. The Company has issued stock options and restricted stock unit (“RSU”) awards with service-based vesting conditions, as well as with performance-based vesting conditions. The Company has not issued awards that include market-based conditions. For service-based awards the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period. For performance-based awards the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period beginning in the period that it becomes probable the performance conditions will occur. At each balance sheet date, the Company evaluates whether any performance conditions related to a performance-based award have changed. The effect of any change in performance conditions would be recognized as a cumulative catch-up adjustment in the period such change occurs, and any remaining unrecognized compensation expense would be recognized on a straight-line basis over the remaining requisite service period. The impact of forfeitures is recognized in the period in which they occur. The Company initially measures the compensation expense of stock-based awards granted to consultants using the grant date fair value of the award. Compensation expense is recognized over the period during which services are rendered by such consultants. At the end of each financial reporting period prior to completion of services being rendered, the compensation expense related to these awards is remeasured using the then current fair value of the Company’s common stock for RSUs, or based upon updated assumptions in the Black-Scholes option pricing model for stock option awards. The Company classifies stock-based compensation expense in its statement of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company estimates its expected stock volatility based on the historical volatility of a set of peer companies, which are publicly traded, and expects to continue to do so until it has adequate historical data regarding the volatility of its own publicly-traded stock price. The expected term of the Company’s stock options has been determined using the “simplified” method for awards that qualify as “plain vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the future. Prior to the Company’s initial public offering in October 2015 (“IPO”), the Company valued its common stock using a hybrid method to estimate its enterprise value. The hybrid method used was a probability-weighted expected return method which was a scenario-based methodology that estimated the fair value of the Company’s common stock based upon an analysis of future values for the Company assuming various outcomes. The hybrid method used calculated equity values using an option pricing model in one or more of scenarios, and also considered the rights of each class of stock. The fair value of each RSU is measured using the closing price of the Company’s common stock on the date of grant. |
Patent Costs | Patent Costs All patent related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. |
Foreign Currency Translation | Foreign Currency Translation The reporting currency of the Company is the U.S. Dollar. The functional currency of ATIL, the Company’s wholly-owned subsidiary, is the British Pound. Assets and liabilities of ATIL are translated into U.S. Dollars based on exchange rates at the end of each reporting period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive loss within the Company’s consolidated balance sheet. Gains and losses resulting from foreign currency transactions are reflected within the Company’s consolidated statement of operations. The Company has not utilized foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. Comprehensive loss is comprised of net loss, foreign currency translation adjustments and unrealized gains (losses) on marketable securities. |
Net Loss per Share | Net Loss per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period, plus the weighted average number of potential shares of common stock from the assumed exercise of stock options, and the assumed vesting of RSUs and restricted stock granted by the Company upon its formation, if dilutive. Since the Company was in a net loss position basic and diluted net loss per share was the same for each of the periods presented. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents, marketable securities and contingent consideration are carried at fair value, determined according to the fair value hierarchy described above. The carrying value of the Company’s accounts payable and accrued expenses approximate fair value due to the short-term nature of these liabilities. |
Concentration of Credit Risk and of Significant Suppliers | Concentration of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds all cash, cash equivalents and marketable securities balances at one accredited financial institution, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party manufacturers to supply drug product, including all underlying components, for its research and development activities, including preclinical and clinical testing. These activities could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients or other components. |
Segment Reporting | Segment Reporting Operating segments are components of a company for which separate financial information is available and evaluated regularly by the chief operating decision maker in assessing performance and deciding how to allocate resources. The Company has two reportable segments, therapeutics and contract research, which are primarily based on its operating segments and operating results used to assess performance. The therapeutics segment is focused on immuno-inflammatory diseases. The contract research segment is focused on providing laboratory services to pharmaceutical and biotech companies looking to supplement their research and development efforts with difficult-to-execute specialty skills and programs. The Company does not allocate assets by segment. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In November 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted for under Topic 606. The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted this standard as of January 1, 2020, the impact of which on its consolidated financial statements was not significant. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40). ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. The standard will be effective for fiscal years beginning after December 15, 2019, including interim periods within such fiscal years. The Company adopted this standard as of January 1, 2020, the impact of which on its consolidated financial statements was not significant. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. This update eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some of the existing disclosure requirements. The standard will be effective for fiscal years beginning after December 15, 2019, including interim periods within such fiscal years. The Company adopted this standard as of January 1, 2020, the impact of which on its consolidated financial statements was not significant. In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718). The amendments in this ASU expand the scope of Topic 718 to include stock-based compensation arrangements with nonemployees except for specific guidance on option pricing model inputs and cost attribution. ASU 2018-07 is effective for annual reporting periods beginning after December 31, 2018, including interim periods within that year. The Company adopted the provisions of this standard as of January 1, 2019, the impact of which on its consolidated financial statements was not significant. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, and 2018-11, Targeted Improvements, which included a number of technical corrections and improvements, including additional options for transition. The new standard establishes a right-of-use model that requires a lessee to record a right-of-use asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods. The amendments in ASU 2016-02 must be applied to all leases existing at the date a company initially applies the standard. The Company adopted the new standard as of January 1, 2019, using the effective date as the date of its initial application, and used the modified retrospective approach. In addition, the Company elected the practical expedients permitted under the transition guidance within the new standard which, among other things, allowed the Company to carry forward the historical lease identification and classification. The Company also elected the practical expedient to not separate lease and non-lease components, as well as the short-term lease practical expedient which allowed the Company to not capitalize leases with terms less than 12 months that do not contain a reasonably certain purchase option. The Company’s consolidated financial statements have not been restated, and disclosures required by the new standard have not been provided, for periods before January 1, 2019. The adoption of ASU 2016-02 resulted in the Company recording additional assets and liabilities of $2,132 and $2,317, respectively, upon adoption on January 1, 2019. The adoption of ASU 2016-02 did not have a material impact on the Company’s consolidated statement of operations or cash flows. |
RHOFADE (Tables)
RHOFADE (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
RHOFADE | |
RHOFADE | |
Schedule of fair value of assets acquired | The following table summarizes the fair value of assets acquired in the acquisition of RHOFADE: Inventory $ 893 Intangible assets, net 66,229 Total assets acquired $ 67,122 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value of Financial Assets and Liabilities | |
Schedule of assets and liabilities measured at fair value on a recurring basis | December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 21,277 $ — $ — $ 21,277 Marketable securities — 39,078 — 39,078 Total assets $ 21,277 $ 39,078 $ — $ 60,355 Liabilities: Acquisition-related contingent consideration $ — $ — $ 1,668 $ 1,668 Total liabilities $ — $ — $ 1,668 $ 1,668 December 31, 2018 Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 49,766 $ 4,992 $ — $ 54,758 Marketable securities — 110,953 — 110,953 Total assets $ 49,766 $ 115,945 $ — $ 165,711 Liabilities: Acquisition-related contingent consideration $ — $ — $ 934 $ 934 Total liabilities $ — $ — $ 934 $ 934 |
Schedule of the fair value of available for sale marketable securities | December 31, 2019 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ 7,815 $ 2 $ — $ 7,817 Commercial paper 15,129 — — 15,129 Asset-backed securities 8,004 4 — 8,008 U.S. government agency debt securities 8,126 1 (3) 8,124 Total marketable securities $ 39,074 $ 7 $ (3) $ 39,078 December 31, 2018 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ 5,030 $ — $ (14) $ 5,016 Commercial paper 67,159 — — 67,159 Asset-backed securities 21,745 — (8) 21,737 U.S. government agency debt securities 17,044 — (3) 17,041 Total marketable securities $ 110,978 $ — $ (25) $ 110,953 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment, Net | |
Schedule of property and equipment, net | December 31, December 31, 2019 2018 Computer equipment $ 1,315 $ 1,292 Finance lease right-of-use assets 435 — Manufacturing equipment — 604 Lab equipment 1,250 1,068 Furniture and fixtures 647 313 Leasehold improvements 889 332 Property and equipment, gross 4,536 3,609 Accumulated depreciation (2,066) (1,322) Property and equipment, net $ 2,470 $ 2,287 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Intangible Assets | |
Schedule of intangible assets | Gross Cost Accumulated Amortization Remaining December 31, December 31, December 31, December 31, Life (years) 2019 2018 2019 2018 Other intangible assets 7.6 751 751 181 106 Total definite-lived intangible assets 751 751 181 106 IPR&D na 6,629 6,629 — — Total intangible assets $ 7,380 $ 7,380 $ 181 $ 106 |
Schedule of estimated future amortization expenses | Year Ending December 31, 2020 $ 75 2021 75 2022 75 2023 75 2024 75 Thereafter 195 Total $ 570 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, December 31, 2019 2018 Employee compensation expenses $ 3,321 $ 4,948 Research and development expenses 2,857 1,437 Professional fees 168 1,123 Other 1,375 580 Total accrued expenses $ 7,721 $ 8,088 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Awards | |
Assumptions used to determine fair value of stock options granted | Year Ended December 31, 2019 2018 2017 Risk-free interest rate 2.27 % 2.66 % 1.93 % Expected term (in years) 6.2 6.3 6.2 Expected volatility 99.36 % 96.78 % 94.19 % Expected dividend yield 0 % 0 % 0 % |
Summary of stock option activity | Weighted Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term Value (in years) Outstanding as of December 31, 2016 2,702,350 $ 18.94 9.05 $ 24,434 Granted 790,100 26.21 Exercised (36,738) 6.40 Forfeited and cancelled (126,955) 22.05 Outstanding as of December 31, 2017 3,328,757 $ 20.69 8.28 $ 19,812 Granted 1,459,800 20.97 Exercised (59,450) 9.70 Forfeited and cancelled (447,026) 24.62 Outstanding as of December 31, 2018 4,282,081 $ 20.53 7.91 $ 2,404 Granted 44,500 5.75 Exercised (142,779) 1.33 Forfeited and cancelled (1,081,581) 23.01 Outstanding as of December 31, 2019 3,102,221 $ 20.33 6.55 $ 148 Options vested and expected to vest as of December 31, 2019 3,102,221 $ 20.33 6.55 $ 148 Options exercisable as of December 31, 2019 2,143,889 (1) $ 19.48 5.93 $ 148 (1) All options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right in the Company’s favor that lapses as the option vests. This amount reflects the number of shares under options that were vested, as opposed to exercisable, as of December 31, 2019. |
Summary of restricted stock units activity | Weighted Average Grant Date Number Fair Value of Shares Per Share Outstanding as of December 31, 2016 219,614 $ 27.43 Granted 117,883 26.27 Vested (40,705) 26.89 Forfeited and cancelled (13,239) 27.53 Outstanding as of December 31, 2017 283,553 $ 27.02 Granted 552,060 19.03 Vested (140,497) 27.22 Forfeited and cancelled (68,709) 23.65 Outstanding as of December 31, 2018 626,407 $ 20.30 Granted 3,650,942 3.56 Vested (173,444) 21.31 Forfeited and cancelled (510,990) 10.63 Outstanding as of December 31, 2019 3,592,915 $ 4.62 |
Stock-based compensation expense | Year Ended December 31, 2019 2018 2017 Cost of revenue $ 703 $ 766 $ 211 Research and development 5,091 6,480 5,471 Sales and marketing — — — General and administrative 10,288 9,317 6,897 Total stock-based compensation expense $ 16,082 $ 16,563 $ 12,579 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Net Loss per Share | |
Basic and diluted net loss per share | Year Ended December 31, 2019 2018 2017 Numerator: Net loss $ (161,354) $ (132,738) $ (68,523) Denominator: Weighted average shares of common stock outstanding 41,323,921 32,909,762 28,102,386 Net loss per share, basic and diluted $ (3.90) $ (4.03) $ (2.44) |
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | December 31, 2019 2018 2017 Options to purchase common stock 3,102,221 4,282,081 3,328,757 Restricted stock unit awards 3,592,915 626,407 283,553 Total potential shares of common stock 6,695,136 4,908,488 3,612,310 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Schedule of lease expense | Year Ended December 31, 2019 Operating lease expense $ 808 Finance Leases: Amortization of right-to-use assets $ 443 Interest expense 87 Total finance lease expenses $ 530 |
Schedule of supplemental balance sheet information related to operating leases | December 31, Operating Leases: 2019 Gross cost $ 5,213 Accumulated amortization (480) Operating lease right-of-use assets $ 4,733 Other current liabilities $ 526 Other liabilities 3,548 Total operating lease liabilities $ 4,074 |
Schedule of supplemental balance sheet information related to finance leases | December 31, Finance Leases: 2019 Property and equipment, gross $ 435 Accumulated depreciation (322) Property and equipment, net $ 113 Other current liabilities $ 111 Other liabilities 21 Total finance lease liabilities $ 132 |
Schedule of future maturities lease liabilities under operating leases | Year Ended December 31, Supplemental Cash Flow Lease Information: 2019 Operating cash flows from operating leases $ 755 Operating cash flows from finance leases 87 Financing cash flows from finance leases 523 Leased assets obtained in exchange for new operating lease liabilities $ 3,060 Weighted-Average Remaining Lease Term (in years): Operating leases Finance leases Weighted-Average Discount Rate: Operating leases % Finance leases % |
Schedule of future maturities lease liabilities under finance leases | Operating Finance Year Ending December 31, Leases Leases 2020 $ 909 $ 116 2021 934 — 2022 959 — 2023 877 — 2024 354 — Thereafter 1,670 — Total undiscounted lease payments 5,703 116 Less: unrecognized interest Total lease liability $ 4,074 $ 111 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Schedule of loss before income taxes by jurisdiction | Year Ended December 31, 2019 2018 2017 U.S. operations $ (161,192) $ (132,473) $ (63,665) Foreign operations (162) (265) (6,688) Loss before income taxes $ (161,354) $ (132,738) $ (70,353) |
Reconciliation of statutory to effective rate | Year Ended December 31, 2019 2018 2017 Federal statutory income tax rate (21.0) % (21.0) % (34.0) % State taxes, net of federal benefit (6.6) (3.5) (9.7) Research and development tax credits (1.5) (2.1) (1.1) Permanent differences 3.0 0.8 0.4 Foreign rate differential — — 1.7 Change in deferred tax asset valuation allowance 26.2 25.7 17.4 Impact of U.S. tax reform — — 22.7 Effective income tax rate 0.1 % (0.1) % (2.6) % |
Schedule of deferred tax assets and liabilities | December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 90,298 $ 57,426 Capitalized start-up costs 6,904 6,954 Research and development tax credit carryforwards 7,417 5,038 Capitalized research and development expense 4,456 2,843 Stock‑based compensation expense 12,973 9,037 Accrued compensation 588 923 Inventory — 271 Other 618 683 Total deferred tax assets 123,254 83,175 Deferred tax liabilities: Property and equipment (206) (674) Intangible asset (1,741) (1,735) Section 481(a) adjustment — — Other (890) (330) Total deferred tax liabilities (2,837) (2,739) Valuation allowance (120,966) (80,985) Deferred tax liabilities, net $ (549) $ (549) |
Changes in deferred tax asset valuation allowance | Year Ended December 31, 2019 2018 2017 Valuation allowance at beginning of year $ (80,985) $ (46,878) $ (30,726) Decreases recorded as benefit to income tax provision — — — Increases resulting from the acquisition of Confluence — — (4,176) Increases recorded to income tax provision (39,981) (34,107) (11,976) Valuation allowance as of end of year $ (120,966) $ (80,985) $ (46,878) |
Schedule of changes in unrecognized tax benefits | Year ended December 31, 2019 2018 2017 Unrecognized tax benefits at beginning of year $ — $ 43 $ — Increases related to prior year tax provisions — 43 Decreases related to prior year tax provisions — (43) — Increases related to current year tax provisions — — — Unrecognized tax benefits as of end of year $ — $ — $ 43 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Discontinued Operations | |
Schedule of discontinued operations | The components of loss from discontinued operations as reported in the Company’s consolidated statement of operations were as follows: Year Ended December 31, 2019 2018 2017 Revenues: Product sales, net $ 13,896 $ 3,940 $ — Total revenue, net 13,896 3,940 — Costs and expenses: Cost of revenue (excludes amortization) 4,522 1,969 — Research and development 503 2,168 3,986 Sales and marketing 23,112 47,827 13,684 General and administrative 2,929 2,058 392 Intangible asset impairment 27,638 — — Amortization of definite-lived intangible 4,426 552 — Total costs and expenses 63,130 54,574 18,062 Loss from discontinued operations (49,234) (50,634) (18,062) Other income, net 1,422 — — Net loss from discontinued operations $ (47,812) $ (50,634) $ (18,062) Net loss from discontinued operations per share, basic and diluted $ (1.16) $ (1.54) $ (0.64) Weighted average common shares outstanding, basic and diluted 41,323,921 32,909,762 28,102,386 The following table presents the details of product sales, net included in discontinued operations: Year Ended December 31, 2019 2018 2017 ESKATA $ 312 $ 2,804 $ — RHOFADE 13,584 1,136 — Total product sales, net $ 13,896 $ 3,940 $ — The following table presents information related to assets and liabilities reported as discontinued operations in the Company’s consolidated balance sheet: December 31, 2019 2018 Accounts receivable, net $ 4,966 $ 4,298 Inventory — 791 Prepaid expenses and other current assets — 1,073 Intangible asset held for sale — — Discontinued operations - current assets $ 4,966 $ 6,162 Property and equipment, net $ — $ 1,993 Intangible assets, net of accumulated amortization — 65,677 Discontinued operations - non-current assets $ — $ 67,670 Accounts payable $ 1,705 $ 3,080 Accrued expenses 2,452 3,898 Current portion of lease liabilities — 459 Discontinued operations - current liabilities $ 4,157 $ 7,437 Other liabilities $ — $ 1,227 Discontinued operations - non- current liabilities $ — $ 1,227 The following table presents certain non-cash items related to discontinued operations, which are included in the Company’s consolidated statement of cash flows: Year Ended December 31, 2019 2018 Depreciation and amortization $ 313 $ 269 Stock-based compensation expense Intangible asset impairment charge 27,638 — Loss on disposal of property and equipment 248 — 28,294 3,759 Gain on sale of RHOFADE 1,670 — Non-cash items, net $ 26,624 $ 3,759 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Segment Information | |
Summary of results of operations by segment | Contract Corporate Total Year Ended December 31, 2019 Therapeutics Research and Other Company Revenue, net $ — $ 16,824 $ (12,597) $ 4,227 Cost of revenue (excludes amortization) — 16,253 (12,198) 4,055 Research and development 65,298 — (399) 64,899 Sales and marketing 620 51 — 671 General and administrative — 2,687 24,469 27,156 Goodwill impairment 18,504 — — 18,504 Loss from operations $ (84,422) $ (2,167) $ (24,469) $ (111,058) Loss from discontinued operations $ (46,305) $ — $ (2,929) $ (49,234) Contract Corporate Total Year Ended December 31, 2018 Therapeutics Research and Other Company Revenue, net $ 1,500 $ 13,135 $ (8,484) $ 6,151 Cost of revenue — 11,399 (7,070) 4,329 Research and development 62,255 — (1,414) 60,841 Sales and marketing 130 40 — 170 General and administrative 30 2,141 23,420 25,591 Loss from operations $ (60,915) $ (445) $ (23,420) $ (84,780) Loss from discontinued operations $ (48,576) $ — $ (2,058) $ (50,634) Contract Corporate Total Year Ended December 31, 2017 Therapeutics Research and Other Company Revenue, net $ — $ 3,202 $ (1,519) $ 1,683 Cost of revenue — 2,726 (1,519) 1,207 Research and development 35,804 — — 35,804 Sales and marketing 85 — — 85 General and administrative 222 673 18,053 18,948 Loss from operations $ (36,111) $ (197) $ (18,053) $ (54,361) Loss from discontinued operations $ (17,670) $ — $ (392) $ (18,062) |
Organization and Nature of Bu_2
Organization and Nature of Business (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Organization and Nature of Business | ||
Cash, cash equivalents and marketable securities | $ 75,015 | |
Accumulated deficit | $ 453,527 | $ 292,173 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2019USD ($) | Sep. 30, 2019employee | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($)item | |
Summary Of Accounting Policies [Line Items] | ||||
Number of employees to be terminated | employee | 86 | |||
Revenue Recognition | ||||
Revenue, Practical Expedient, Financing Component [true false] | false | |||
Revenue, Practical Expedient, Incremental Cost of Obtaining Contract [true false] | true | |||
Number of active research grants | item | 2 | |||
Remaining funds available to the Company under grants | $ 0 | |||
Inventory | ||||
Inventory | 0 | $ 791 | ||
EPI Health, LLC | ||||
Cash, Cash Equivalents and Restricted Cash | ||||
Cash deposited in escrow | $ 1,750 | $ 1,750 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computer equipment | |
Summary Of Accounting Policies [Line Items] | |
Depreciation period (in years) | 3 years |
Manufacturing equipment | |
Summary Of Accounting Policies [Line Items] | |
Depreciation period (in years) | 5 years |
Lab equipment | |
Summary Of Accounting Policies [Line Items] | |
Depreciation period (in years) | 5 years |
Furniture and fixtures | |
Summary Of Accounting Policies [Line Items] | |
Depreciation period (in years) | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Intangible Assets (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
RHOFADE | |
Disaggregation of Revenue [Line Items] | |
Write-down of equipment held for sale | $ 27,638 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Summary Of Accounting Policies [Line Items] | ||
Goodwill | $ 18,504 | |
Goodwill impairment charge | $ 18,504 | |
Confluence | ||
Summary Of Accounting Policies [Line Items] | ||
Goodwill | $ 18,504 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Stock-Based Compensation (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Summary of Significant Accounting Policies | |||
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Segments (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Summary of Significant Accounting Policies | |
Number of operating segments | 2 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Recent Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Lease liability | $ 4,074 | |
Adjustment | ASU 2016-02 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
ROU assets | $ 2,132 | |
Lease liability | $ 2,317 |
RHOFADE - Amount Paid for Asset
RHOFADE - Amount Paid for Assets Acquired (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2017 | |
Business Acquisition [Line Items] | |||
Cash consideration paid | $ 9,647 | ||
Percentage of payments received in connection with license or sublicense of assets transferred | 25.00% | ||
EPI Health, LLC | |||
Business Acquisition [Line Items] | |||
Upfront payment made | $ 35,000 | ||
Cash deposited in escrow | 1,750 | $ 1,750 | |
Payment for certain inventory | 200 | ||
Potential milestones payable | $ 20,000 | ||
Period of royalty payment from first commercial sale | 10 years |
RHOFADE - Summary of Fair Value
RHOFADE - Summary of Fair Value Assets Acquired (Details) - Allergan $ in Thousands | 1 Months Ended |
Nov. 30, 2018USD ($) | |
Business Acquisition [Line Items] | |
Upfront payment made | $ 66,100 |
APA | |
Business Acquisition [Line Items] | |
Amortization on straight-line basis | 10 years |
APA | Nonrecurring | |
Business Acquisition [Line Items] | |
Inventory | $ 893 |
Intangible assets, net | 66,229 |
Total assets acquired | $ 67,122 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Nov. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Assets: | |||
Marketable securities | $ 39,078 | $ 110,953 | |
Liabilities: | |||
Transfers from Level 1 to Level 2 | 0 | 0 | |
Transfers from Level 2 to Level 1 | 0 | 0 | |
Transfers into or out of Level 3 | 0 | 0 | |
Change in fair value of contingent consideration | 734 | 1,272 | |
Confluence | |||
Liabilities: | |||
Change in fair value of contingent consideration | 734 | ||
Fair value of common stock | $ 2,200 | ||
Recurring | |||
Assets: | |||
Cash equivalents | 21,277 | 54,758 | |
Marketable securities | 39,078 | 110,953 | |
Total assets measured at fair value | 60,355 | 165,711 | |
Liabilities: | |||
Acquisition-related contingent consideration | 1,668 | 934 | |
Total liabilities measured at fair value | 1,668 | 934 | |
Recurring | Level 1 | |||
Assets: | |||
Cash equivalents | 21,277 | 49,766 | |
Total assets measured at fair value | 21,277 | 49,766 | |
Recurring | Level 2 | |||
Assets: | |||
Cash equivalents | 4,992 | ||
Marketable securities | 39,078 | 110,953 | |
Total assets measured at fair value | 39,078 | 115,945 | |
Recurring | Level 3 | |||
Liabilities: | |||
Acquisition-related contingent consideration | 1,668 | 934 | |
Total liabilities measured at fair value | $ 1,668 | $ 934 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - By Type (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Marketable securities: | ||
Amortized Cost | $ 39,074 | $ 110,978 |
Gross Unrealized Gain | 7 | |
Gross Unrealized Loss | (3) | (25) |
Fair Value | 39,078 | 110,953 |
Corporate debt securities | ||
Marketable securities: | ||
Amortized Cost | 7,815 | 5,030 |
Gross Unrealized Gain | 2 | |
Gross Unrealized Loss | (14) | |
Fair Value | 7,817 | 5,016 |
Commercial paper | ||
Marketable securities: | ||
Amortized Cost | 15,129 | 67,159 |
Fair Value | 15,129 | 67,159 |
Asset-backed securities | ||
Marketable securities: | ||
Amortized Cost | 8,004 | 21,745 |
Gross Unrealized Gain | 4 | |
Gross Unrealized Loss | (8) | |
Fair Value | 8,008 | 21,737 |
U.S. government agency debt securities | ||
Marketable securities: | ||
Amortized Cost | 8,126 | 17,044 |
Gross Unrealized Gain | 1 | |
Gross Unrealized Loss | (3) | (3) |
Fair Value | $ 8,124 | $ 17,041 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property and Equipment, Net | |||
Finance lease right-of-use assets | $ 435 | ||
Property and equipment, gross | 4,536 | $ 3,609 | |
Accumulated depreciation | (2,066) | (1,322) | |
Property and equipment, net | 2,470 | 2,287 | |
Depreciation | 1,511 | 1,248 | $ 370 |
Computer equipment | |||
Property and Equipment, Net | |||
Property and equipment, gross | 1,315 | 1,292 | |
Manufacturing equipment | |||
Property and Equipment, Net | |||
Property and equipment, gross | 604 | ||
Lab equipment | |||
Property and Equipment, Net | |||
Property and equipment, gross | 1,250 | 1,068 | |
Furniture and fixtures | |||
Property and Equipment, Net | |||
Property and equipment, gross | 647 | 313 | |
Leasehold improvements | |||
Property and Equipment, Net | |||
Property and equipment, gross | $ 889 | $ 332 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Definite-lived intangible assets | ||
Gross Cost | $ 751 | $ 751 |
Accumulated Amortization | 181 | 106 |
Intangible assets, net | ||
Gross cost | 7,380 | 7,380 |
IPR&D | ||
Indefinite-lived intangible assets | ||
Gross cost | $ 6,629 | 6,629 |
Other intangible assets | ||
Finite Lived And Indefinite Lived Intangible Assets By Major Class [Line Items] | ||
Remaining life | 7 years 7 months 6 days | |
Definite-lived intangible assets | ||
Gross Cost | $ 751 | 751 |
Accumulated Amortization | $ 181 | $ 106 |
Intangible Assets - Future Amor
Intangible Assets - Future Amortization Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization expense | $ 75 | $ 75 | $ 31 |
Future amortization expenses | |||
2020 | 75 | ||
2021 | 75 | ||
2022 | 75 | ||
2023 | 75 | ||
2024 | 75 | ||
Thereafter | 195 | ||
Total | $ 570 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued Expenses | ||
Employee compensation expenses | $ 3,321 | $ 4,948 |
Research and development expenses | 2,857 | 1,437 |
Professional fees | 168 | 1,123 |
Other | 1,375 | 580 |
Total accrued expenses | $ 7,721 | $ 8,088 |
Debt (Details)
Debt (Details) - USD ($) $ in Thousands | Oct. 15, 2018 | Oct. 31, 2019 | Oct. 31, 2018 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||||
Loan amount borrowed | $ (30,000) | |||
Secured Debt | ||||
Debt Instrument [Line Items] | ||||
Loan, maximum borrowing capacity | $ 65,000 | |||
Loan amount borrowed | $ 30,000 | |||
Repayment of loan | $ 30,000 | |||
Number of consecutive monthly payments | 24 months | |||
Final payment fee percentage | 5.75% | |||
Minimum | Secured Debt | ||||
Debt Instrument [Line Items] | ||||
Annual interest rate | 8.35% | |||
London Interbank Offered Rate (LIBOR) | Secured Debt | ||||
Debt Instrument [Line Items] | ||||
Basis spread over LIBOR | 6.25% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)Vote$ / sharesshares | Dec. 31, 2018$ / sharesshares | |
Stockholders' Equity | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 |
Number of votes per share | Vote | 1 | |
Dividends declared | $ | $ 0 |
Stockholders' Equity - Other Of
Stockholders' Equity - Other Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2018 | Aug. 31, 2017 | Apr. 30, 2017 | Dec. 31, 2017 | |
At The Market Offering | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued | 635,000 | |||
Issuance price (in dollars per share) | $ 31.50 | |||
Aggregate gross proceeds | $ 20,003 | |||
Expenses related to stock issuance | $ 691 | |||
Net offering proceeds | $ 19,311 | |||
At The Market Offering | Common Stock | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued | 635,000 | |||
Public Offering August 2017 | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued | 3,747,602 | |||
Issuance price (in dollars per share) | $ 23.02 | |||
Aggregate gross proceeds | $ 86,270 | |||
Underwriters' discounts and commissions | 5,176 | |||
Expenses related to stock issuance | 176 | |||
Offering proceeds, net of discounts, commissions and expenses | $ 80,918 | |||
Public Offering October 2018 | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of shares issued | 9,941,750 | |||
Issuance price (in dollars per share) | $ 10.75 | |||
Aggregate gross proceeds | $ 106,874 | |||
Underwriters' discounts and commissions | 6,412 | |||
Expenses related to stock issuance | 257 | |||
Net offering proceeds | $ 100,205 |
Stock-Based Awards (Details)
Stock-Based Awards (Details) - shares | Jan. 01, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 14, 2015 | Jul. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2015 |
Stock-based awards | ||||||||
Options granted (in shares) | 44,500 | 1,459,800 | 790,100 | |||||
Options outstanding | 3,102,221 | 4,282,081 | 3,328,757 | 2,702,350 | ||||
Stock Option Valuation | ||||||||
Risk-free interest rate (as a percent) | 2.27% | 2.66% | 1.93% | |||||
Expected term (in years) | 6 years 2 months 12 days | 6 years 3 months 18 days | 6 years 2 months 12 days | |||||
Expected volatility (as a percent) | 99.36% | 96.78% | 94.19% | |||||
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | |||||
2017 Inducement Plan | ||||||||
Stock-based awards | ||||||||
Number of shares authorized | 1,000,000 | |||||||
2015 Equity Incentive Plan | ||||||||
Stock-based awards | ||||||||
Number of shares authorized | 1,643,872 | |||||||
Number of shares available for grant | 817,586 | |||||||
Percentage increase to shares available for grant from common outstanding as of preceding December 31 (as a percent) | 4.00% | |||||||
Additional shares available | 1,451,997 | |||||||
2012 Equity Compensation Plan | ||||||||
Stock-based awards | ||||||||
Number of shares available for grant | 0 | |||||||
Options granted (in shares) | 1,140,524 | |||||||
Options outstanding | 745,735 | 984,761 | ||||||
Vesting period (in years) | 4 years | |||||||
Term of award (in years) | 10 years |
Stock-Based Awards - Option Act
Stock-Based Awards - Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Options, Number of Shares | ||||
Number of Shares, beginning balance | 4,282,081 | 3,328,757 | 2,702,350 | |
Number of Shares, Granted | 44,500 | 1,459,800 | 790,100 | |
Number of Shares, Exercised | (142,779) | (59,450) | (36,738) | |
Number of Shares, Forfeited and cancelled | (1,081,581) | (447,026) | (126,955) | |
Number of Shares, ending balance | 3,102,221 | 4,282,081 | 3,328,757 | 2,702,350 |
Number of Shares, Options vested and expected to vest | 3,102,221 | |||
Number of Shares, Options exercisable | 2,143,889 | |||
Options, Weighted Average Exercise Price | ||||
Weighted Average Exercise Price, beginning balance (in dollars per share) | $ 20.53 | $ 20.69 | $ 18.94 | |
Weighted Average Exercise Price, Granted (in dollars per share) | 5.75 | 20.97 | 26.21 | |
Weighted Average Exercise Price, Exercised (in dollars per share) | 1.33 | 9.70 | 6.40 | |
Weighted Average Exercise Price, Forfeited and cancelled (in dollars per share) | 23.01 | 24.62 | 22.05 | |
Weighted Average Exercise Price, ending balance (in dollars per share) | 20.33 | $ 20.53 | $ 20.69 | $ 18.94 |
Weighted Average Exercise Price, Options vested and expected to vest (in dollars per share) | 20.33 | |||
Weighted Average Exercise Price, Options exercisable (in dollars per share) | $ 19.48 | |||
Options, Weighted Average Remaining Contractual Term | ||||
Weighted Average Remaining Contractual Term (in years) | 6 years 6 months 18 days | 7 years 10 months 28 days | 8 years 3 months 11 days | 9 years 18 days |
Weighted Average Remaining Contractual Term, Options vested and expected to vest (in years) | 6 years 6 months 18 days | |||
Weighted Average Remaining Contractual Term, Options exercisable (in years) | 5 years 11 months 5 days | |||
Aggregate Intrinsic Value | ||||
Aggregate Intrinsic Value | $ 148 | $ 2,404 | $ 19,812 | $ 24,434 |
Aggregate Intrinsic Value, Options vested and expected to vest | 148 | |||
Aggregate Intrinsic Value, Options exercisable | $ 148 | |||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 4.63 | $ 16.55 | $ 20.28 |
Stock-Based Awards - RSUs (Deta
Stock-Based Awards - RSUs (Details) - Restricted stock unit awards - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
RSU, Number of Units | |||
Units outstanding, beginning of period | 626,407 | 283,553 | 219,614 |
Granted | 3,650,942 | 552,060 | 117,883 |
Vested | (173,444) | (140,497) | (40,705) |
Forfeited and cancelled | (510,990) | (68,709) | (13,239) |
Units outstanding, end of period | 3,592,915 | 626,407 | 283,553 |
RSU, Weighted Average Grant Date Fair Value Per Unit | |||
Weighted average grant date fair value, beginning balance (in dollars per share) | $ 20.30 | $ 27.02 | $ 27.43 |
Granted, estimated grant-date fair value (in dollars per share) | 3.56 | 19.03 | 26.27 |
Weighted average grant date fair value, vested (in dollars per share) | 21.31 | 27.22 | 26.89 |
Forfeited and cancelled, estimated grant date fair value (in dollars per share) | 10.63 | 23.65 | 27.53 |
Weighted average grant date fair value, ending balance (in dollars per share) | $ 4.62 | $ 20.30 | $ 27.02 |
Stock-Based Awards - Compensati
Stock-Based Awards - Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-based compensation expense | |||
Stock-based compensation expense | $ 16,082 | $ 16,563 | $ 12,579 |
Unrecognized stock-based compensation cost, options | 13,150 | ||
Unrecognized compensation, RSUs | 12,195 | ||
Cost of revenue. | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 703 | 766 | 211 |
Research and development | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 5,091 | 6,480 | 5,471 |
General and administrative | |||
Stock-based compensation expense | |||
Stock-based compensation expense | $ 10,288 | $ 9,317 | $ 6,897 |
Options to purchase common stock | |||
Stock-based compensation expense | |||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 1 year 9 months 22 days | ||
Restricted stock unit awards | |||
Stock-based compensation expense | |||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 2 years 4 months 6 days |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Numerator: | |||
Net loss | $ (161,354) | $ (132,738) | $ (68,523) |
Denominator: | |||
Weighted average shares of common stock outstanding (in shares) | 41,323,921 | 32,909,762 | 28,102,386 |
Net loss per share, basic and diluted | $ (3.90) | $ (4.03) | $ (2.44) |
Net Loss per Share - Anti-dilut
Net Loss per Share - Anti-dilution (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 6,695,136 | 4,908,488 | 3,612,310 |
Options to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 3,102,221 | 4,282,081 | 3,328,757 |
Restricted stock unit awards | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 3,592,915 | 626,407 | 283,553 |
Leases - Lease Costs (Details)
Leases - Lease Costs (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Lease Costs | |
Operating lease expense | $ 808 |
Amortization of right-to-use assets | 443 |
Interest expense | 87 |
Total finance lease expenses | $ 530 |
Leases (Details)
Leases (Details) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Feb. 28, 2019ft² | Nov. 30, 2017ft² | |
Lessee, Lease, Description [Line Items] | |||||
Loss on lease termination | $ 248 | ||||
Rent expense | $ 886 | $ 946 | |||
Area leased, sublease agreement | ft² | 21,056 | 33,019 | |||
Rent expense | 987 | ||||
Total renovation and improvement costs | $ 808 | ||||
Finance lease term | 4 years | ||||
Operating Leases: | |||||
Gross cost | $ 4,536 | 3,609 | |||
Accumulated amortization | (2,066) | (1,322) | |||
Property and equipment, net | 2,470 | $ 2,287 | |||
Other current liabilities | $ 526 | ||||
Financial position | us-gaap:OtherLiabilitiesCurrent | ||||
Other liabilities | $ 3,548 | ||||
Financial position | us-gaap:OtherLiabilitiesNoncurrent | ||||
Total operating lease liabilities | $ 4,074 | ||||
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Total operating lease liabilities | ||||
Operating Leases | |||||
Operating Leases: | |||||
Gross cost | $ 5,213 | ||||
Accumulated amortization | (480) | ||||
Property and equipment, net | $ 4,733 |
Leases - Finance Leases (Detail
Leases - Finance Leases (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | |
Finance Leases: | ||
Property and equipment, gross | $ 4,536 | $ 3,609 |
Accumulated depreciation | (2,066) | (1,322) |
Property and equipment, net | 2,470 | $ 2,287 |
Total finance lease liabilities | $ 111 | |
Number of capital lease arrangements | item | 2 | |
Finance Leases | ||
Finance Leases: | ||
Property and equipment, gross | $ 435 | |
Accumulated depreciation | (322) | |
Property and equipment, net | 113 | |
Other current liabilities | $ 111 | |
Financial position | us-gaap:OtherLiabilitiesCurrent | |
Other liabilities | $ 21 | |
Financial position | us-gaap:OtherLiabilitiesNoncurrent | |
Total finance lease liabilities | $ 132 |
Leases - Supplemental Informati
Leases - Supplemental Information Related to Operating and Finance Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases | |
Operating cash flows from operating leases | $ 755 |
Operating cash flows from finance leases | 87 |
Financing cash flows from finance leases | 523 |
Leased assets obtained in exchange for new operating lease liabilities | $ 3,060 |
Weighted-Average Remaining Lease Term (in years): | |
Operating leases | 6 years 9 months 15 days |
Finance leases | 10 months 28 days |
Weighted-Average Discount Rate: | |
Operating leases | 10.10% |
Finance leases | 10.00% |
Leases - Future Maturities of L
Leases - Future Maturities of Lease Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating Leases | |
2020 | $ 909 |
2021 | 934 |
2022 | 959 |
2023 | 877 |
2024 | 354 |
Thereafter | 1,670 |
Total undiscounted lease payments | 5,703 |
Less: unrecognized interest | (1,629) |
Total lease liability | 4,074 |
Finance Leases | |
2020 | 116 |
Total undiscounted lease payments | 116 |
Less: unrecognized interest | (5) |
Total lease liability | $ 111 |
Income Taxes - Tax Cuts and Job
Income Taxes - Tax Cuts and Jobs Act (Details) - USD ($) $ in Thousands | Dec. 22, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Effect Of Tax Cuts And Jobs Act Of 2017 [Abstract] | ||||
Date accounting was completed | Dec. 31, 2017 | |||
Federal statutory income tax rate | 35.00% | 21.00% | 21.00% | 34.00% |
Tax expense attributable to revaluation of deferred tax liabilities, net | $ 18,507 | |||
Reduction in valuation allowance | $ 20,344 | |||
Tax benefit attributable to revaluation of deferred tax liabilities, net, after effect on valuation allowance | $ 1,837 | |||
Tax impact of one-time transition tax | $ 0 |
Income Taxes - Rate Reconciliat
Income Taxes - Rate Reconciliation (Details) - USD ($) $ in Thousands | Dec. 22, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Income Taxes | ||||
Federal income tax benefit | $ 0 | $ 0 | $ 0 | |
State income tax benefit | 0 | 0 | 0 | |
Loss before income taxes | ||||
U.S. operations | (161,192) | (132,473) | (63,665) | |
Foreign operations | (162) | (265) | (6,688) | |
Loss before income taxes | $ (161,354) | $ (132,738) | $ (70,353) | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||||
Federal statutory income tax rate | (35.00%) | (21.00%) | (21.00%) | (34.00%) |
State taxes, net of federal benefit | (6.60%) | (3.50%) | (9.70%) | |
Research and development tax credits | (1.50%) | (2.10%) | (1.10%) | |
Permanent differences | 3.00% | 0.80% | 0.40% | |
Foreign rate differential | 1.70% | |||
Change in deferred tax asset valuation allowance | 26.20% | 25.70% | 17.40% | |
Impact of U.S. tax reform | (22.70%) | |||
Effective income tax rate | 0.10% | (0.10%) | (2.60%) |
Income Taxes - Deferred Assets
Income Taxes - Deferred Assets and Liabilities, CFDs (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Components of net deferred tax assets | ||||
Net operating loss carryforwards | $ 90,298 | $ 57,426 | ||
Capitalized start-up costs | 6,904 | 6,954 | ||
Research and development tax credit carryforwards | 7,417 | 5,038 | ||
Capitalized research and development expenses | 4,456 | 2,843 | ||
Stock-based compensation expenses | 12,973 | 9,037 | ||
Accrued compensation | 588 | 923 | ||
Inventory | 271 | |||
Other | 618 | 683 | ||
Total deferred tax assets | 123,254 | 83,175 | ||
Property and equipment | (206) | (674) | ||
Intangible asset | (1,741) | (1,735) | ||
Other | (890) | (330) | ||
Total deferred tax liabilities | (2,837) | (2,739) | ||
Valuation allowance | (120,966) | (80,985) | $ (46,878) | $ (30,726) |
Deferred tax liabilities, net | (549) | $ (549) | ||
United Kingdom Tax Authority | ||||
Components of net deferred tax assets | ||||
Operating loss carryforwards | 1,675 | |||
Federal | ||||
Components of net deferred tax assets | ||||
Operating loss carryforwards | 326,113 | |||
Federal | Research Tax Credit Carryforward [Member] | ||||
Components of net deferred tax assets | ||||
Tax credit carryforward | 7,323 | |||
State | ||||
Components of net deferred tax assets | ||||
Operating loss carryforwards | 338,822 | |||
State | Research Tax Credit Carryforward [Member] | ||||
Components of net deferred tax assets | ||||
Tax credit carryforward | $ 118 |
Income Taxes - Valuation Allowa
Income Taxes - Valuation Allowance and Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Changes in valuation allowance for deferred tax assets | |||
Valuation allowance at beginning of year | $ (80,985) | $ (46,878) | $ (30,726) |
Increases resulting from the acquisition of Confluence | (4,176) | ||
Increases recorded to income tax provision | (39,981) | (34,107) | (11,976) |
Valuation allowance as of end of year | (120,966) | (80,985) | (46,878) |
Unrecognized Tax Benefits | |||
Unrecognized tax benefits at beginning of year | 43 | ||
Increases related to prior year tax provisions | 43 | ||
Decreases related to prior year tax provisions | (43) | ||
Unrecognized tax benefits as of end of year | 43 | ||
Unrecognized tax benefits that would impact effective tax rate | 0 | 0 | |
Unrecognized tax benefits, recognized expense (benefit) related to interest and penalties | $ 0 | $ 0 | $ 3 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Related Party Transactions | ||||
Amount due to related party | $ 0 | $ 0 | ||
NST, LLC | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | 0 | 0 | $ 208 | |
Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc [Member] | ||||
Related Party Transactions | ||||
Aggregate royalty payments | 611 | 51 | 0 | |
Mallinckrodt PlC | ||||
Related Party Transactions | ||||
Other revenue earned from related party transactions | 97 | 0 | ||
Board of Directors Chairman [Member] | Direct sublease agreement | ||||
Related Party Transactions | ||||
Lease termination charge | $ (590) | 506 | ||
Expenses incurred under related party transactions | $ 0 | $ 570 | $ 318 |
Agreements Related to Intelle_2
Agreements Related to Intellectual Property (Details) shares in Thousands, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||||
May 31, 2019USD ($) | Nov. 30, 2018USD ($)shares | Apr. 30, 2017USD ($) | Mar. 31, 2016USD ($)item | Aug. 31, 2012 | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Oct. 31, 2019USD ($)installment | Sep. 30, 2019USD ($) | Aug. 31, 2015USD ($) | |
Confluence | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Payment in cash | $ 2,500 | ||||||||||
Number of shares | shares | 253,208 | ||||||||||
Fair value of common stock | $ 2,200 | ||||||||||
Additional contingent consideration based on milestones, maximum, per Agreement | 75,000 | ||||||||||
Royalty term | 10 years | ||||||||||
Allergan | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Upfront payment made | $ 66,100 | ||||||||||
Allergan | Achievement Of Development Milestones | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Milestone payment | $ 5,000 | ||||||||||
Rigel | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Potential milestones payable | $ 10,500 | $ 10,000 | |||||||||
Milestone payment | $ 4,000 | ||||||||||
Aggregate milestone payments | $ 80,000 | ||||||||||
Amendment fees payable | $ 1,500 | ||||||||||
Number of installments | installment | 3 | ||||||||||
Amendment fees payable, per installment | $ 500 | ||||||||||
Assignment Agreement and Finder's Services Agreement | A-101 45% Topical Solution | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Term of agreement, minimum | 15 years | ||||||||||
Finder's Services Agreement | Achievement Of Dosing Of First Subject With A101 | A-101 45% Topical Solution | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Milestone payment | $ 1,000 | ||||||||||
Finder's Services Agreement | Achievement Of Specified Commercial Milestones | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Aggregate royalty payments | 14 | 112 | $ 0 | ||||||||
Finder's Services Agreement | Achievement Of Specified Commercial Milestones | A-101 45% Topical Solution | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Milestone payment | $ 1,500 | ||||||||||
Potential future milestone payments | $ 3,000 | ||||||||||
License and Collaboration Agreement | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Upfront payment revenue | 1,000 | ||||||||||
License and Collaboration Agreement | JAK inhibitors | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Period from first commercial product sale that royalties are owed (in years) | 10 years | ||||||||||
License and Collaboration Agreement | Achievement Of Development Milestones | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Milestone payment revenue | 500 | ||||||||||
Stock Purchase Agreement | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Term of agreement, minimum | 10 years | ||||||||||
Amount of required annual payment under the contract | $ 100 | ||||||||||
Stock Purchase Agreement | Achievement Of Specified Commercial Milestones | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Potential future milestone payments | $ 22,500 | ||||||||||
Stock Purchase Agreement | Achievement Of Pre Commercialization Milestones | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Number of products | item | 3 | ||||||||||
Potential future milestone payments | $ 18,000 | ||||||||||
License Agreement | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Term of agreement, minimum | 10 years | ||||||||||
Annual maintenance fee | $ 10 | ||||||||||
License Agreement | Achievement Of Specified Commercial Milestones | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Potential future milestone payments | 11,600 | ||||||||||
APA | Allergan | |||||||||||
Agreements Related to Intellectual Property | |||||||||||
Aggregate royalty payments | $ 1,359 | $ 114 | $ 0 |
Retirement Savings Plan (Detail
Retirement Savings Plan (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Retirement Savings Plan | |||
Employer match of employee contributions (as a percent) | 100.00% | ||
Employee earnings subject to employer match (as a percent) | 4.00% | ||
Company contributions | $ 740 | $ 662 | $ 270 |
Restructuring Charges (Details)
Restructuring Charges (Details) $ in Thousands | 1 Months Ended | 12 Months Ended |
Sep. 30, 2019employee | Dec. 31, 2019USD ($) | |
Restructuring Cost and Reserve [Line Items] | ||
Number of employees | employee | 86 | |
Expenses recognized | $ 2,748 | |
Payments made | 2,316 | |
Contingent retention bonus | 339 | |
Retention bonus accrued | $ 208 | |
Minimum | ||
Restructuring Cost and Reserve [Line Items] | ||
Period for which transition services is provided by noticed employees | 4 months | |
Maximum | ||
Restructuring Cost and Reserve [Line Items] | ||
Period for which transition services is provided by noticed employees | 10 months | |
Terminated employees | ||
Restructuring Cost and Reserve [Line Items] | ||
Number of employees | employee | 63 | |
Noticed employees | ||
Restructuring Cost and Reserve [Line Items] | ||
Number of employees | employee | 23 |
Discontinued Operations - Loss
Discontinued Operations - Loss (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | |||
Total revenue, net | $ 13,896 | $ 3,940 | |
Cost of revenue (excludes amortization) | 4,522 | 1,969 | |
Research and development | 503 | 2,168 | $ 3,986 |
Sales and marketing | 23,112 | 47,827 | 13,684 |
General and administrative | 2,929 | 2,058 | 392 |
Intangible asset impairment | 27,638 | ||
Amortization of definite-lived intangible | 4,426 | 552 | |
Total costs and expenses | 63,130 | 54,574 | 18,062 |
Loss from discontinued operations | (49,234) | (50,634) | (18,062) |
Other income, net | 1,422 | ||
Net loss from discontinued operations | $ (47,812) | $ (50,634) | $ (18,062) |
Net loss from discontinued operations per share, basic and diluted | $ (1.16) | $ (1.54) | $ (0.64) |
Weighted average common shares outstanding, basic and diluted (in shares) | 41,323,921 | 32,909,762 | 28,102,386 |
Product sales | |||
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | |||
Total revenue, net | $ 13,896 | $ 3,940 | |
ESKATA | |||
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | |||
Total revenue, net | 312 | 2,804 | |
RHOFADE | |||
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | |||
Total revenue, net | $ 13,584 | $ 1,136 |
Discontinued Operations - Asset
Discontinued Operations - Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disposal Group, Including Discontinued Operation, Balance Sheet Disclosures [Abstract] | ||
Accounts receivable, net | $ 4,966 | $ 4,298 |
Inventory | 791 | |
Prepaid expenses and other current assets | 1,073 | |
Discontinued operations - current assets | 4,966 | 6,162 |
Property and equipment, net | 1,993 | |
Intangible assets, net of accumulated amortization | 65,677 | |
Discontinued operations - non-current assets | 67,670 | |
Accounts payable | 1,705 | 3,080 |
Accrued expenses | 2,452 | 3,898 |
Current portion of lease liabilities | 459 | |
Discontinued operations - current liabilities | $ 4,157 | 7,437 |
Other liabilities | 1,227 | |
Discontinued operations - non- current liabilities | $ 1,227 |
Discontinued Operations - Cash
Discontinued Operations - Cash Flow (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Depreciation and amortization | $ 313 | $ 269 |
Stock-based compensation expense | 95 | 3,490 |
Intangible asset impairment charge | 27,638 | |
Loss on disposal of property and equipment | 248 | |
Non-cash items | 28,294 | 3,759 |
Non-cash items, net | 26,624 | $ 3,759 |
RHOFADE | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Gain on sale of RHOFADE | $ 1,670 |
Discontinued Operations (Detail
Discontinued Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Accounts receivable, net | $ 4,966 | $ 4,298 |
Loss on lease termination | 248 | |
Impairment charge | 27,638 | |
RHOFADE | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Accounts receivable, net | 4,966 | $ 3,838 |
Impairment charge | $ 27,638 |
Segment Information (Details)
Segment Information (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Segment Reporting Information [Line Items] | |||
Number of reportable segments | item | 2 | ||
Revenue, net | $ 4,227 | $ 6,151 | $ 1,683 |
Cost of revenue | 4,055 | 4,329 | 1,207 |
Research and development | 64,899 | 60,841 | 35,804 |
Sales and marketing | 671 | 170 | 85 |
General and administrative | 27,156 | 25,591 | 18,948 |
Goodwill impairment | 18,504 | ||
Amortization expense | 75 | 75 | 31 |
Loss from operations | (111,058) | (84,780) | (54,361) |
Loss from discontinued operations | (49,234) | (50,634) | (18,062) |
Dermatology Therapeutics Segment | |||
Segment Reporting Information [Line Items] | |||
Revenue, net | 1,500 | ||
Research and development | 65,298 | 62,255 | 35,804 |
Sales and marketing | 620 | 130 | 85 |
General and administrative | 30 | 222 | |
Goodwill impairment | 18,504 | ||
Loss from operations | (84,422) | (60,915) | (36,111) |
Loss from discontinued operations | (46,305) | (48,576) | (17,670) |
Contract Research Segment | |||
Segment Reporting Information [Line Items] | |||
Revenue, net | 16,824 | 13,135 | 3,202 |
Cost of revenue | 16,253 | 11,399 | 2,726 |
Sales and marketing | 51 | 40 | |
General and administrative | 2,687 | 2,141 | 673 |
Loss from operations | (2,167) | (445) | (197) |
Corporate and Other | |||
Segment Reporting Information [Line Items] | |||
Revenue, net | (12,597) | (8,484) | (1,519) |
Cost of revenue | (12,198) | (7,070) | (1,519) |
Research and development | (399) | (1,414) | |
General and administrative | 24,469 | 23,420 | 18,053 |
Loss from operations | (24,469) | (23,420) | (18,053) |
Loss from discontinued operations | (2,929) | $ (2,058) | (392) |
Intersegment Eliminations | Contract Research Segment | |||
Segment Reporting Information [Line Items] | |||
Revenue, net | $ (125,978,484) | $ (1,519) |
Legal Proceedings (Details)
Legal Proceedings (Details) | Jan. 24, 2020item |
Executive officer | |
Other Commitments [Line Items] | |
Number Of Defendants | 2 |