Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 14, 2020 | Jun. 28, 2019 | |
Document and Entity Information | |||
Entity Registrant Name | Adamas Pharmaceuticals Inc | ||
Entity Central Index Key | 0001328143 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Public Float | $ 140,168,658 | ||
Entity Common Stock, Shares Outstanding (in shares) | 28,012,844 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Shell Company | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 65,774 | $ 56,605 |
Available-for-sale securities | 66,833 | 154,265 |
Accounts receivable, net | 5,770 | 5,511 |
Inventory | 5,267 | 5,121 |
Prepaid expenses and other current assets | 6,676 | 6,871 |
Total current assets | 150,320 | 228,373 |
Property and equipment, net | 2,449 | 3,652 |
Operating lease right-of-use assets | 8,048 | |
Prepaid expenses and other non-current assets | 1,341 | 2,789 |
Total assets | 162,158 | 234,814 |
Current liabilities | ||
Accounts payable | 6,932 | 6,570 |
Accrued liabilities | 16,117 | 15,530 |
Current portion of long-term debt | 2,041 | 1,664 |
Other current liabilities | 1,858 | 512 |
Total current liabilities | 26,948 | 24,276 |
Long-term debt | 125,674 | 117,457 |
Long-term portion of operating lease liabilities | 8,272 | |
Other non-current liabilities | 2,157 | 3,196 |
Total liabilities | 163,051 | 144,929 |
Commitments and Contingencies (Note 9) | ||
Stockholders’ equity (deficit) | ||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at December 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.001 par value — 100,000,000 shares authorized, 27,964,778 and 27,434,358 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 33 | 32 |
Additional paid-in capital | 446,942 | 432,815 |
Accumulated other comprehensive gain (loss) | 16 | (264) |
Accumulated deficit | (447,884) | (342,698) |
Total stockholders’ equity (deficit) | (893) | 89,885 |
Total liabilities and stockholders’ equity (deficit) | $ 162,158 | $ 234,814 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in share) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 27,964,778 | 27,434,358 |
Common stock, shares outstanding (in shares) | 27,964,778 | 27,434,358 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | |||
Total revenues | $ 54,637 | $ 34,046 | $ 571 |
Costs and operating expenses: | |||
Cost of product sales | 2,469 | 633 | 17 |
Research and development | 30,034 | 39,300 | 27,168 |
Selling, general and administrative, net | 114,369 | 109,135 | 61,312 |
Total costs and operating expenses | 146,872 | 149,068 | 88,497 |
Loss from operations | (92,235) | (115,022) | (87,926) |
Interest and other income, net | 2,093 | 3,115 | 1,351 |
Interest expense | (15,044) | (19,092) | (4,645) |
Loss before income taxes | (105,186) | (130,999) | (91,220) |
Benefit for income taxes | 0 | 0 | (1,730) |
Net loss | $ (105,186) | $ (130,999) | $ (89,490) |
Net loss per share, basic and diluted (in dollars per share) | $ (3.80) | $ (4.87) | $ (3.97) |
Weighted average shares used in computing net loss per share, basic and diluted (in shares) | 27,677 | 26,886 | 22,558 |
Product sales | |||
Revenues: | |||
Total revenues | $ 54,637 | $ 34,046 | $ 568 |
License and grant revenue | |||
Revenues: | |||
Total revenues | $ 0 | $ 0 | $ 3 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (105,186) | $ (130,999) | $ (89,490) |
Unrealized gain (loss) on available-for-sale securities | 280 | (97) | 26 |
Comprehensive loss | $ (104,906) | $ (131,096) | $ (89,464) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2016 | 22,013,644 | ||||
Beginning balance at Dec. 31, 2016 | $ 132,183 | $ 27 | $ 254,558 | $ (193) | $ (122,209) |
Increase (decrease) in shareholders' equity | |||||
Exercise of stock options (in shares) | 1,183,353 | ||||
Exercise of stock options | $ 9,034 | $ 1 | 9,033 | ||
Restricted stock units vested (in shares) | 64,471 | ||||
Restricted stock units vested | $ 201 | ||||
Stock issued under employee stock purchase plan (in shares) | 59,083 | ||||
Stock issued under employee stock purchase plan | 766 | 766 | |||
Net unrealized gain (loss) on available-for-sale securities | 26 | 26 | |||
Stock-based compensation | 13,406 | 13,406 | |||
Net loss | (89,490) | (89,490) | |||
Ending balance (in shares) at Dec. 31, 2017 | 23,320,551 | ||||
Ending balance at Dec. 31, 2017 | 66,126 | $ 28 | 277,964 | (167) | (211,699) |
Increase (decrease) in shareholders' equity | |||||
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs (in shares) | 3,450,000 | ||||
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs | 134,268 | $ 4 | 134,264 | ||
Exercise of stock options (in shares) | 478,454 | ||||
Exercise of stock options | $ 3,362 | $ 0 | 3,362 | ||
Restricted stock units vested (in shares) | 105,396 | ||||
Restricted stock units vested | $ 0 | ||||
Stock issued under employee stock purchase plan (in shares) | 79,957 | ||||
Stock issued under employee stock purchase plan | 1,237 | 1,237 | |||
Net unrealized gain (loss) on available-for-sale securities | (97) | (97) | |||
Stock-based compensation | 15,988 | 15,988 | |||
Net loss | (130,999) | (130,999) | |||
Ending balance (in shares) at Dec. 31, 2018 | 27,434,358 | ||||
Ending balance at Dec. 31, 2018 | 89,885 | $ 32 | 432,815 | (264) | (342,698) |
Increase (decrease) in shareholders' equity | |||||
Exercise of stock options (in shares) | 184,626 | ||||
Exercise of stock options | $ 293 | $ 0 | 293 | ||
Restricted stock units vested (in shares) | 151,288 | ||||
Restricted stock units vested | $ 0 | ||||
Stock issued under employee stock purchase plan (in shares) | 194,506 | ||||
Stock issued under employee stock purchase plan | 775 | $ 1 | 774 | ||
Net unrealized gain (loss) on available-for-sale securities | 280 | 280 | |||
Stock-based compensation | 13,060 | 13,060 | |||
Net loss | (105,186) | (105,186) | |||
Ending balance (in shares) at Dec. 31, 2019 | 27,964,778 | ||||
Ending balance at Dec. 31, 2019 | $ (893) | $ 33 | $ 446,942 | $ 16 | $ (447,884) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | |||
Net loss | $ (105,186,000) | $ (130,999,000) | $ (89,490,000) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Depreciation | 1,214,000 | 1,460,000 | 1,194,000 |
Stock-based compensation | 12,852,000 | 15,786,000 | 13,367,000 |
Accretion of interest expense | 15,044,000 | 19,092,000 | 4,645,000 |
Change in fair value of embedded derivative liability | 805,000 | 882,000 | (294,000) |
Net accretion of discounts and amortization of premiums of available-for-sale securities | (1,219,000) | (1,045,000) | 456,000 |
Loss on disposal of fixed assets | 0 | 123,000 | 0 |
Provision for write-down of inventory | 884,000 | 232,000 | 0 |
Changes in assets and liabilities | |||
Accrued interest of available-for-sale securities | 50,000 | 74,000 | (161,000) |
Accounts receivable, net | (259,000) | (5,144,000) | 427,000 |
Inventory | (970,000) | (3,273,000) | (1,646,000) |
Prepaid expenses and other assets | 1,560,000 | (5,036,000) | (2,036,000) |
Operating lease right-of-use assets | 1,008,000 | ||
Accounts payable | 398,000 | 2,759,000 | 333,000 |
Current portion of long-term debt | (6,450,000) | (2,618,000) | 0 |
Long-term portion of operating lease liabilities | (1,188,000) | 0 | 0 |
Accrued liabilities and other liabilities | 678,000 | 3,484,000 | 6,378,000 |
Net cash used in operating activities | (80,779,000) | (104,223,000) | (66,827,000) |
Cash flows from investing activities | |||
Purchases of property and equipment | (18,000) | (1,064,000) | (1,258,000) |
Purchases of available-for-sale securities | (93,869,000) | (200,354,000) | (62,510,000) |
Maturities of available-for-sale securities | 182,750,000 | 132,080,000 | 89,333,000 |
Net cash provided by (used in) investing activities | 88,863,000 | (69,338,000) | 25,565,000 |
Cash flows from financing activities | |||
Proceeds from public offerings, net of offering costs | 0 | 134,268,000 | 0 |
Proceeds from issuance of long-term debt | 0 | 0 | 99,600,000 |
Payment of debt issuance costs | 0 | 0 | (633,000) |
Proceeds from issuance of common stock upon exercise of stock options | 310,000 | 3,345,000 | 9,110,000 |
Proceeds from employee stock purchase plan | 775,000 | 1,237,000 | 766,000 |
Net cash provided by financing activities | 1,085,000 | 138,850,000 | 108,843,000 |
Net increase (decrease) in cash and cash equivalents | 9,169,000 | (34,711,000) | 67,581,000 |
Cash and cash equivalents at beginning of period | 56,605,000 | 91,316,000 | 23,735,000 |
Cash and cash equivalents at end of period | 65,774,000 | 56,605,000 | 91,316,000 |
Supplemental disclosure | |||
Cash paid for interest | 6,450,000 | 2,618,000 | 0 |
Supplemental disclosure of noncash activities | |||
Right-of-use assets obtained in exchange for operating lease liabilities | 9,056,000 | ||
Property and equipment in accounts payable and accrued expense | 0 | 7,000 | 61,000 |
Stock-based compensation capitalized in inventory | 208,000 | 202,000 | 39,000 |
Stock option exercise settled after period end | 0 | 17,000 | 0 |
Property and equipment acquired through tenant improvement allowance | $ 0 | $ 1,129,000 | $ 0 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS At Adamas Pharmaceuticals, Inc. (the “Company”), its purpose is to make everyday life significantly better for people affected by neurological diseases. With one partnered product and a commercial medicine, the Company is focused on growing a portfolio of therapies to reduce the burden of neurological diseases on patients, caregivers, and society. In August 2017, the U.S. Food and Drug Administration (FDA) approved GOCOVRI ® (amantadine) extended release capsules, the first and only FDA-approved medication indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company was incorporated in the State of Delaware on November 15, 2000, and operates as one segment. The Company’s headquarters and operations are located in Emeryville, California. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition and variable consideration, lease assets and liabilities, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, inventory, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates. Liquidity During the last three fiscal years, the Company has funded its operations primarily through a Royalty-Backed Loan with HealthCare Royalty Partners (“HCRP”), sales of GOCOVRI, and sales of its common stock. In 2017, the Company entered into a Royalty-Backed Loan with HCRP, whereby the Company borrowed a total of $100.0 million. The Company made GOCOVRI available for physician and patient use in the fourth quarter of 2017, with a full commercial launch in January 2018. In January 2018, the Company completed a follow-on public offering of its common stock from which proceeds raised were approximately $134.3 million, net of underwriting discounts, commissions, and offering-related transaction costs. Prior to the generation of revenue from GOCOVRI, the Company had not generated any commercial revenue from the sale of its products. As of December 31, 2019, the Company had $132.6 million of cash, cash equivalents, and investments, which management believes will be sufficient to fund its projected operating requirements, including commercialization of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease and operations related to the continued development of ADS-5102 for other indications including MSW, for at least 12 months from the issuance of this annual report on Form 10-K. However, it is possible that the Company will not achieve the progress it expects, because revenues from GOCOVRI may be less than anticipated and the actual costs and timing of drug development, particularly clinical studies, and regulatory approvals are difficult to predict, subject to substantial risks and delays, and often vary depending on the particular indication and development strategy. Reclassification Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to current period presentation Inventory Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory consists of raw materials, work-in-process, and GOCOVRI finished goods. Raw materials and work-in-process that may be utilized for both commercial and clinical programs are identical and, as a result, the inventory has an “alternative future use” as defined in authoritative guidance and are included in inventory. Amounts in inventory associated with clinical development programs are charged to research and development expense when the product enters the research and development process and can no longer be used for commercial purposes and, therefore, does not have “alternative future use”. Costs include active pharmaceutical ingredient (API), third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. If the Company identifies excess, obsolete or unsalable product, the Company will write down its inventory to net realizable value in the period it is identified. During 2019 and 2018, the Company recorded a $0.9 million and $0.2 million write-down of GOCOVRI inventory, respectively. No such charges were recorded in 2017. The Company begins capitalizing costs as inventory when the product candidate receives regulatory approval. Prior to regulatory approval, inventory costs related to product candidates are recorded as research and development expense. The Company received FDA approval for GOCOVRI on August 24, 2017, and began capitalizing inventory manufactured at the FDA approved location, after FDA approval. Cash and Cash Equivalents Cash and cash equivalents consist of highly liquid investments with original maturities, when purchased, of less than three months. Investments The Company classifies its investments as “available-for-sale.” In general, these investments are free of trading restrictions. The Company carries these investments at fair value, based on quoted market prices or other readily available market information. Quoted market prices for U.S. government and corporate bonds include both principal and accrued interest components. Unrealized gains and losses are included in accumulated other comprehensive income, which is reflected as a separate component of stockholders’ equity in its Consolidated Balance Sheets. Gains and losses are recognized when realized in its Consolidated Statements of Operations. When the Company determines that an other-than-temporary decline in fair value has occurred, the amount of the decline that is related to a credit loss is recognized in income. Gains and losses are determined using the specific identification method. The Company considers all marketable debt securities with a maturity of less than one year to be short-term investments, with all others considered to be long-term investments. All of the Company’s available-for-sale securities are subject to a periodic impairment review. The Company recognizes an impairment charge when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary. Factors considered in determining whether a loss is temporary include the length of time and extent to which the investments’ fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, extent of the loss related to credit of the issuer, the expected cash flows from the security, its intent to sell or hold the security, and whether or not the Company will be required to sell the security before the recovery of its amortized cost. Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. Segments In accordance with ASC 280-10-50, Segment Reporting, operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in one reportable segment: the development and commercialization of therapeutics targeting chronic disorders of the central nervous system. All revenues for the years ended December 31, 2019, 2018, and 2017 were generated in the United States. Revenue Recognition Effective January 1, 2018, the Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , using the full retrospective transition method. The Company recognizes revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity 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) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. Product sales The Company’s product sales consist of U.S. sales of GOCOVRI. GOCOVRI was approved by the FDA on August 24, 2017, and the Company commenced shipments of GOCOVRI to a specialty pharmacy during October 2017. The Company sells its products principally to a specialty pharmacy and certain specialty distributors (each a “Customer” or collectively its “Customers”). These agreements with its Customers provide for transfer of title to the product at the time the product has been delivered to and accepted by the Customer. The Customer subsequently dispenses product directly to a patient. In addition, except for limited circumstances, the Customer has no right of product return to the Company. The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. The Company has determined that the delivery of its product to Customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its Customers. The trade payment terms with its Customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. The Company considers the effects of items which can decrease the transaction price such as variable consideration and consideration payable to a Customer or payer. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition: Distribution Fees : Distribution fees include fees paid to the Company’s Customers for data and prompt payment discounts. Distribution fees are recorded based on contractual terms. Rebates : Rebates include mandated discounts under the Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, TRICARE Retail Pharmacy Refunds Program (TRICARE), and commercial contracts. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements with benefit providers. Rebates are estimated based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on data received from the specialty pharmacy and specialty distributor. The Company uses the expected-value method for estimating rebates and estimates are adjusted quarterly to reflect actual experience. Chargebacks : Chargebacks are discounts that occur when Healthcare Providers purchase directly from a Customer. Healthcare Providers, which currently consist of Public Health Service institutions, non-profit clinics, government entities, group purchasing organizations, and health maintenance organizations, generally purchase the product at a discounted price. The Customer, in turn, charges back to the Company the difference between the price initially paid by the Customer and the discounted price paid by the Healthcare Providers to the Customer. The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer. Product Returns : Consistent with industry practice, the Company offers limited product return rights and generally allows for the return of product that is damaged or defective, and within a few months prior to and up to a few months after the product expiration date. The Company does not allow product returns for product that has been dispensed to a patient. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, prescription trends, and other relevant factors. Product returns have been insignificant to date and are expected to be immaterial in the future. Medicare Part D Coverage Gap : Medicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid in arrears. The impact of the Medicare Part D coverage gap is estimated using the expected-value method based on an amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters and is adjusted quarterly based on actual experience. Co-payment Assistance : The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. Co-payment assistance is estimated using the expected-value method based on historical program participation and estimates of program redemption using data provided by third-party administrators. Each of the above items are variable consideration, are recorded at the time of revenue recognition, and require significant estimates, judgment and information obtained from external sources. The Company determined a significant reversal of revenue would not occur in a future period for the estimates of variable consideration detailed above and, therefore, the transaction price was not reduced during the periods presented. If management’s estimates differ from actual results, the Company will record adjustments that would affect product sales in the period of adjustment. License agreement revenue The Company generates revenue from collaboration and license agreements for the development and commercialization of products. Collaboration and license agreements may include non-refundable upfront license fees, partial or complete reimbursement of research and development costs, contingent consideration milestone payments based on the achievement of defined objectives, and royalties on sales of commercialized products. Such agreements may contain various promises to customers which are generally capable of being distinct and accounted for as separate performance obligations. The Company’s duties and responsibilities under the collaboration and license agreements typically include the license or transfer of intellectual property rights, obligations to provide research and development services and related materials, and obligations to participate on certain development and/or commercialization committees with the partners. These promises may be regarded as separate performance obligations, or bundled as a single performance obligation, depending upon the nature of the arrangement. For agreements with multiple performance obligations, the Company allocates estimated revenue to each performance obligation at contract inception based on the estimated relative standalone selling price (SSP) of each performance obligation in the arrangement. Revenue allocated to each performance obligation is then recognized when the entity satisfies the performance obligation by transferring control of the promised good or service to the customer. Licenses for Intellectual Property (IP) : If the Company determines that the license for IP is distinct from the other performance obligations identified in the arrangement, revenue from non-refundable, up-front fees allocated to the license is recognized when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, judgment is applied to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : For contracts with customers that contain payments that are contingent upon achievement of a substantive milestone, at the inception of each arrangement that includes development 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 transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative SSP basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in the period of adjustment. Reimbursement of Research and Development Costs: Amounts related to research and development funding and full-time equivalent employees assigned to the license agreement are recognized over time as the related services or activities are performed, in accordance with the contract terms. Royalties : For arrangements that include sales-based royalties, and the licensed IP is deemed to be the predominant item to which the royalties relate, the Company recognizes the related royalty revenue at the later of (i) when the related sales occur, or (ii) the satisfaction or partial satisfaction of the performance obligation to which the royalty relates. Cost of Product Sales Cost of product sales consists primarily of direct and indirect costs related to the manufacturing of GOCOVRI products sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs. Cost of product sales may also include period costs related to certain inventory manufacturing services, inventory adjustment charges, as well as manufacturing variances. In connection with the FDA approval of GOCOVRI on August 24, 2017, the Company began capitalizing inventory manufactured at the FDA approved location starting in August 2017. Prior to receiving regulatory approval for GOCOVRI from the FDA, the Company expensed all costs incurred in the manufacture of GOCOVRI as research and development. Concentration of Risk Credit Risk Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and short and long-term investments. Cash, cash equivalents, and investments are deposited with financial institutions or invested in security issuers that management believes are credit worthy. Deposits may, at times, exceed the amount of insurance provided on such deposits. Risks associated with cash, cash equivalents, and investments are mitigated by the Company’s investment policy which defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. Major Customers The Company has entered into distribution agreements with a specialty pharmacy and certain limited specialty distributors. For the years ended December 31, 2019 and 2018, the Company’s largest customer represented approximately 98% and 99% of the Company’s product revenue, respectively, and approximately 96% and 99% of the Company’s accounts receivable balance at December 31, 2019 and 2018, respectively. Major Suppliers The Company does not currently have any of its own manufacturing facilities, and therefore it depends on an outsourced manufacturing strategy for the production of GOCOVRI for commercial use and for the production of its product candidates for clinical trials. The Company has contracts in place with one third-party manufacturer that is approved for the commercial production of GOCOVRI and one third-party supplier that is approved for GOCOVRI’s active pharmaceutical ingredient. Although there are potential sources of supply other than the Company’s existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. Accounts Receivable, net The Company’s accounts receivable balance consists of amounts due from sales of GOCOVRI. Receivables from sales of GOCOVRI are recorded net of allowances which generally include chargebacks, doubtful accounts, and discounts. Allergan receivables are for research and development funding and full-time equivalent employees assigned to the Allergan license agreement, as well as for reimbursement of external costs, recorded as contra-expense, associated with supporting prosecution and litigation of intellectual property rights. The Company’s estimate of the allowance for doubtful accounts is based on an evaluation of the aging of its receivables. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature and historical collectability of the Company’s accounts receivable, the Company determined that an allowance for doubtful accounts was not required at December 31, 2019. Property and Equipment Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations in the period realized. Estimated useful lives by major asset category are as follows: Useful Lives Computer equipment and software 3 years Equipment 5 years Furniture and fixtures 10 years Leases The Company determines if an arrangement is, or contains, a lease at inception. An arrangement is, or contains, a lease if it conveys the right to control the use of identified property, plant or equipment (i.e., an identified asset) for a period of time in exchange for consideration. The Company’s arrangements determined to be or contain a lease include explicitly or implicitly identified assets where the Company has the right to substantially all of the economic benefits of the assets and has the ability to direct how and for what purpose the assets are used during the lease term. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term and any amounts probable of being owed under a residual value guarantee (if applicable). In determining the incremental borrowing rate used to calculate the present value of lease payments, the Company uses the interest rate specified in the lease. If the rate is not readily determinable, which is generally the case for the Company, the Company uses its incremental borrowing rate based on the information available at the commencement date. The operating lease ROU assets also include any lease payments made (including any prepaid rents and initial direct costs) and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense for lease payments is recognized on a straight-line basis over the expected lease term. The Company has lease agreements with lease components and non-lease components. For its facility and office equipment lease, the Company accounts for the lease and non-lease components separately. For its vehicle leases, the Company elected the practical expedient to not separate lease components, such as base rent payments, and non-lease components, such as interest, and also applies a portfolio approach to effectively account for the operating lease ROU assets and liabilities, given the volume of individual leases involved in the overall arrangement. Accounting for Long-Lived Assets The Company reviews its long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by the comparison of the carrying amount to the future net cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. There have been no such impairments of long-lived assets as of December 31, 2019. Clinical Trial Accruals The Company’s clinical trial accruals are based on estimates of patient enrollment and related activities at clinical investigator sites, as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical trials on the Company’s behalf. The Company estimates clinical trial expenses based on the estimated services performed pursuant to these contracts, as provided by the CRO. These estimates are reviewed for reasonableness by the Company’s internal clinical personnel. The Company monitors patient enrollment levels and related activities using available information; however, if the Company underestimates activity levels associated with various studies at a given point in time, the Company could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. Research and Development Research and development (“R&D”) expenses include salaries and related compensation, contractor and consultant fees, external clinical trial expenses performed by CROs, licensing fees, acquired intellectual property with no alternative future use, and facility and administrative expense allocations. In addition, the Company funds R&D at research institutions under agreements that are generally cancelable at its option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of pre-approval inventory purchases, product formulation, chemical analysis, and the transfer and scale-up of manufacturing at facilities operated by the Company’s contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2, and Phase 3 clinical trials. These costs are a significant component of the Company’s research and development expenses. Long-Term Debt Long-term debt consists of the Company’s loan agreement with HCRP. The Company accounted for the loan agreement as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the debt will be repaid. Debt issuance costs have been recorded as a debt discount in the Company’s consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the loan using the effective interest rate method. The Company must make certain assumptions and estimates, including future royalties and net product sales, in determining the expected repayment term, amortization period of the debt discount, accretion of interest expense, as well as the classification between current and long-term portions. The Company periodically assesses these assumptions and estimates, and adjusts the liabilities accordingly. Under the terms of the loan, HCRP has recourse to Adamas Pharma, LLC, not the Company. See Note 10 - Long-Term Debt, for further details of the Company’s long-term debt. Embedded Derivatives Related to Debt Instruments Embedded derivatives that are required to be bifurcated from their host contract are evaluated and valued separately from the debt instrument. Under the Company’s loan agreement with HCRP, upon the occurrence of a default or a change in control, the Company may be required to make mandatory prepayments of the borrowings. The prepayment premium is considered an embedded derivative, as the holder of the loans may exercise the option to require prepayment by the Company. Further, in the event of a regulatory change that results in a material adverse effect on HCRP’s rate of return, the Company shall pay directly to HCRP an amount that compensates HCRP for such reduction. The embedded derivative is presented as a component of other non-current liabilities. The Company will remeasure the embedded derivatives each reporting period and report changes in the estimated fair value as gains or losses in interest and other income, net, in the consolidated statement of operations. Fair Value of Financial Instruments The carrying value of the Company’s cash and cash equivalents, short-term investments, accounts receivable, long-term investments and other current assets, other assets, accounts payable, accrued liabilities approximate fair value due to the short-term nature or determinable value of these items. See also Note 3 for further details of the Company’s fair value instruments. Income Taxes The Company accounts for income taxes under the asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to th |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS In accordance with ASC 820-10, Fair Value Measurements and Disclosures, the Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows: • Level 1 inputs, which include quoted prices in active markets for identical assets or liabilities; • Level 2 inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For available-for-sale securities, the Company reviews trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and • Level 3 inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgment or estimation. The following table represents the fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis (in thousands): December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market $ 27,720 $ 27,720 $ — $ — Corporate debt 22,576 — 22,576 — U.S. Treasury notes 37,811 — 37,811 — Commercial paper 10,928 $ — 10,928 $ — Total assets measured at fair value $ 99,035 $ 27,720 $ 71,315 $ — Liabilities: Embedded derivative liability $ 2,157 $ — $ — $ 2,157 Total liabilities measured at fair value $ 2,157 $ — $ — $ 2,157 December 31, 2018 Total Level 1 Level 2 Level 3 Assets: Money market $ 17,789 $ 17,789 $ — $ — Corporate debt 19,792 — 19,792 — U.S. Treasury notes 131,512 — 131,512 — Commercial paper 2,961 — 2,961 — Total assets measured at fair value $ 172,054 $ 17,789 $ 154,265 $ — Liabilities: Embedded derivative liability $ 1,352 $ — $ — $ 1,352 Total liabilities measured at fair value $ 1,352 $ — $ — $ 1,352 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. Corporate debt, U.S. Treasury securities, and commercial paper are measured at fair value using Level 2 inputs. The Company reviews trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. In certain cases where there is limited activity or less transparency around inputs to valuation, the related assets or liabilities are classified as Level 3. The Company classified an embedded derivative related to the Company’s royalty-backed loan agreement (the “Royalty-Backed Loan”) with HealthCare Royalty Partners (“HCRP”) as a Level 3 liability. The fair value of the embedded derivative as a result of a change in control was calculated using a probability-weighted discounted cash flow model. The model used in valuing this embedded derivative requires the use of significant estimates and assumptions including but not limited to: 1) expected cash flows the Company expects to receive on U.S. net sales of GOCOVRI and on royalties from Allergan on U.S. net sales of Namzaric; 2) the Company’s risk adjusted discount rates; and 3) the probability of a change in control occurring during the term of the note based on the percentage of similar companies that were acquired over the previous five year period. Changes in the estimated fair value of the bifurcated embedded derivative are reported as gains or losses in interest and other income, net, in the consolidated statement of operations. In the periods presented, the Company evaluated the embedded derivative value as a result of an event of default and the value as a result of increased costs due to a regulatory change and considered both to have no material value based on current assessment of probability, but could become material in future periods if a specified event of default or regulatory change became more probable than is currently estimated. See Note 10 “Long-Term Debt” for further description. The following table sets forth a summary of the changes in the estimated fair value of the Company’s embedded derivative, which is measured at fair value as a Level 3 liability on a recurring basis (in thousands): Balance as of December 31, 2016 $ — Issuance of long-term debt with embedded derivative 764 Change in fair value included in interest and other income, net (294) Balance as of December 31, 2017 470 Change in fair value included in interest and other income, net 882 Balance as of December 31, 2018 1,352 Change in fair value included in interest and other income, net 805 Balance as of December 31, 2019 $ 2,157 There were no transfers between any of the levels of the fair value hierarchy during the years ended December 31, 2019 and 2018. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | INVESTMENTS The Company’s investments consist of corporate debt, U.S. Treasury securities, and commercial paper classified as available-for-sale securities. The Company limits the amount of investment exposure as to institution, maturity, and investment type. To mitigate credit risk, the Company invests in investment grade corporate debt, U.S. Treasury securities, and commercial paper. Such securities are reported at fair value, with unrealized gains and losses excluded from earnings and shown separately as a component of accumulated other comprehensive loss within stockholders’ equity. Realized gains and losses are reclassified from other comprehensive loss to other income on the consolidated statements of operations when incurred. The Company may pay a premium or receive a discount upon the purchase of available-for-sale securities. Interest earned and gains realized on available-for-sale securities and amortization of discounts received and accretion of premiums paid on the purchase of available-for-sale securities are included in investment income. The following table is a summary of amortized cost, unrealized gain and loss, and the fair value of available-for-sale securities as of December 31, 2019, and 2018 (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 22,582 $ 3 $ (9) $ 22,576 U.S. Treasury notes 37,789 22 — 37,811 Commercial paper 6,446 — — 6,446 Total $ 66,817 $ 25 $ (9) $ 66,833 Reported as: Short-term investments $ 66,817 $ 25 $ (9) $ 66,833 Long-term investments — — — — Total $ 66,817 $ 25 $ (9) $ 66,833 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 19,833 $ — $ (41) $ 19,792 U.S. Treasury notes 131,735 10 (233) 131,512 Commercial paper 2,961 — — 2,961 Total $ 154,529 $ 10 $ (274) $ 154,265 Reported as: Short-term investments $ 154,529 $ 10 $ (274) $ 154,265 Long-term investments — — — — Total $ 154,529 $ 10 $ (274) $ 154,265 Short-term investments include accrued interest of $0.4 million and $0.5 million as of December 31, 2019 and 2018, respectively. The Company has not incurred any realized gains or losses on investments for the years ended December 31, 2019 and 2018. Investments are classified as short-term or long-term depending on the underlying investment’s maturity date. The Company had no investments with a maturity date greater than 12 months as of December 31, 2019 and 2018. All investments with unrealized losses at December 31, 2019, have been in a loss position for less than twelve months or the loss is not material and were temporary in nature. The Company does not intend to sell the investments that are in an unrealized loss position before recovery of their amortized cost basis. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | BALANCE SHEET COMPONENTS Prepaid expenses and other current assets (in thousands) December 31, 2019 2018 Prepaid expenses $ 2,624 $ 2,969 Prepaid clinical trial 2,710 2,299 Income tax receivable 1,259 840 Other current assets 83 763 Prepaid expenses and other current assets $ 6,676 $ 6,871 Property and equipment, net (in thousands) December 31, 2019 2018 Computer equipment and software $ 3,297 $ 3,286 Equipment 384 384 Furniture and fixtures 336 336 Leasehold improvements 1,891 1,891 5,908 5,897 Less: Accumulated depreciation and amortization (3,459) (2,245) Property and equipment, net $ 2,449 $ 3,652 Depreciation expense was $1.2 million, $1.5 million, and $1.2 million for the years ended December 31, 2019, 2018, and 2017, respectively. Accrued liabilities (in thousands) December 31, 2019 2018 Accrued employee related costs $ 7,682 $ 7,472 Clinical trial accruals 1,680 2,434 Accrued consulting and other professional fees 4,867 4,230 Accrued sales deductions 1,822 1,053 Other 66 341 Accrued liabilities $ 16,117 $ 15,530 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY The Company began capitalizing inventory in August 2017 once the FDA approved GOCOVRI. Inventory consists of the following (in thousands): December 31, 2019 2018 Raw materials $ 1,057 $ 1,330 Work-in-process 1,925 2,174 Finished goods 2,285 1,617 Total inventory $ 5,267 $ 5,121 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2019 | |
License Agreements | |
License Agreements | LICENSE AGREEMENTS In November 2012, the Company granted Forest Laboratories Holdings Limited “Forest”, an indirect, wholly-owned subsidiary of Allergan plc (collectively “Allergan”) an exclusive license, with right to sublicense, certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells Namzaric ® and Namenda XR ® for the treatment of moderate to severe dementia related to Alzheimer’s disease. Pursuant to the agreement, Allergan made an upfront payment of $65.0 million. The Company earned and received additional cash payments totaling $95.0 million upon achievement by Allergan of certain development and regulatory milestones. Under the agreement, external costs incurred related to the prosecution and litigation of intellectual property rights are reimbursable. Reimbursable external costs are recorded as a reduction to selling, general and administrative, net. For the twelve months ended December 31, 2019, 2018, and 2017, there were zero, $1,000, and $33,000 of reimbursable external costs, respectively, for prosecution or litigation of intellectual property rights. In addition, the Company may earn tiered royalty payments based on future net sales of Namzaric and Namenda XR; however, Allergan’s obligation to pay royalties for any product covered by the license is eliminated in any quarter where there is significant competition from generics. Beginning in May 2020, the Company will be entitled to receive royalties at rates in the low double digits to mid-teens from Allergan for sales of Namzaric in the United States. Based on 2019 net sales of Namzaric, the Company expects the tiered royalty to be in the low double digits through the term of the agreement. Allergan’s obligation to pay royalties with respect to fixed-dose memantine-donepezil products, including Namzaric, continues until the later of (i) 15 years after the commercial launch of the first fixed-dose memantine-donepezil product by Allergan in the United States or (ii) the expiration of the Orange Book listed patents for which Allergan obtained rights from the Company covering such product. Beginning in June 2018, the Company was entitled to receive royalties at rates in the low to mid-single digits for sales of Namenda XR in the United States. The Company does not expect to receive royalties on net sales of Namenda XR, due to the entry of generic versions of Namenda XR. Royalties under the license agreement will be recognized when the related sales occur, in accordance with the sales-based royalty exception. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | LEASES Lease Commitments The Company performed an evaluation of its contracts in accordance with Topic 842 and determined that, except for its facility, vehicle, and office equipment leases, described below, none of its other contracts contain a lease. The Company evaluated all its leases and determined they were operating leases. In January 2018, the Company amended its Emeryville, California, office facility lease agreement to extend the term to April 30, 2025, and relocate and expand its office space to 37,626 rentable square feet within the same building. The lease contains an option to extend the term for one additional five In 2018, the Company entered into a three In March 2019, the Company entered into a three As of December 31, 2019, the Company did not have additional operating leases that have not yet commenced. Supplemental balance sheet information related to operating leases were as follows (in thousands): December 31, 2019 Assets Operating lease right-of-use assets $ 8,048 Total right-of-use assets $ 8,048 Liabilities Current portion included in other current liabilities $ 1,669 Long-term portion of operating lease liabilities 8,272 Total operating lease liabilities $ 9,941 The Company’s total lease cost was approximately $2.4 million for the year ended December 31, 2019; total rent expense was approximately $1.2 million and $0.7 million for the years ended December 31, 2018, and 2017, respectively. The components of lease costs, which were included in selling, general and administrative, net in its consolidated statements of operations, were as follows (in thousands): Year Ended December 31, 2019 Operating lease cost $ 2,037 Variable lease cost 320 Total lease cost $ 2,357 As of December 31, 2019, the maturities of operating lease liabilities were as follows (in thousands): Operating leases 2020 $ 2,603 2021 2,610 2022 2,431 2023 2,181 2024 2,247 Thereafter 764 Total lease payments 12,836 Less: Imputed interest (2,895) Operating lease liabilities $ 9,941 As of December 31, 2019, the weighted average remaining lease term is 4.9 years and the weighted average operating discount rate used to determine the operating lease liability was 10.3%. ASC 840 Disclosure The Company elected the alternative modified transition method and included the following tables previously disclosed. As of December 31, 2018, future minimum lease payments under the non-cancelable facility operating lease, were as follows (in thousands): Amount 2019 $ 1,938 2020 1,996 2021 2,056 2022 2,118 2023 2,181 Thereafter 3,011 Total $ 13,300 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Purchase Commitments The Company has entered into agreements for the supply of API and the manufacture of commercial supply of GOCOVRI, with Moehs Ibérica, S.L. and Catalent Pharma Solutions, LLC, respectively. Under the terms of the agreements, the Company will supply the vendors with non-cancelable firm commitment purchase orders. The Company has also entered into other agreements with certain vendors for the provision of services, including services related to data access and packaging, under which the Company is contractually obligated to make certain payments to the vendors. The Company enters into contracts in the normal course of business that include, among others, arrangements with CROs for clinical trials, vendors for preclinical research, and vendors for manufacturing. These contracts generally provide for termination upon notice, and therefore the Company believes that its obligations under these agreements are not material. As of December 31, 2019, the Company had non-cancelable purchase commitments of $4.0 million due within one year. Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. Indemnification In accordance with the Company’s amended and restated certificate of incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. The Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for claims. In addition, in the normal course of business, the Company enters into contracts and agreements that may contain a variety of representations and warranties and provide for general indemnifications. For example, the Company provided certain indemnifications to its agents and underwriters as part of the Company’s January 2018 underwritten secondary public offering of common stock. Underwriters have now made a claim to such indemnifications in conjunction with the ongoing litigation involving that transaction. Litigation and Other Legal Proceedings In November 2012, the Company granted Forest an exclusive license to certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in the United States. Under the terms of that license agreement, Forest has the right to enforce such intellectual property rights which are related to its right to market and sell Namzaric and Namenda XR for the treatment of moderate to severe dementia related to Alzheimer’s disease. The Company has a right to participate in, but not control, such enforcement actions by Forest. In 2018 and as of the date of this filing, multiple generic companies have launched generic versions of Namenda XR. As of the date of this filing, a number of companies have submitted ANDAs including one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(iv) to the FDA requesting approval to manufacture and market generic versions of Namzaric, on which the Company is entitled to receive royalties from Forest beginning in May 2020. As of the date of this filing, the Company and Forest have settled with all such Namzaric ANDA filers, including all first filers on all the available dosage forms of Namzaric. Subject to those agreements, the earliest date on which any of these agreements grants a license to market generic version of Namzaric is January 1, 2025 or in the alternative, an option to launch an authorized generic version of Namzaric beginning on January 1, 2026, or earlier in certain circumstances. The Company and Forest intend to continue to enforce the patents associated with Namzaric. On February 16, 2018, Osmotica Pharmaceuticals LLC and Vertical Pharmaceuticals LLC (“Osmotica”) filed an action against the Company in U.S. District Court for the state of Delaware, requesting a declaratory judgment that Osmotica’s newly-approved product Osmolex ER™ (amantadine) extended release tablets do not infringe certain of the Company’s patents. On September 20, 2018, the Company filed its first amended answer including infringement counterclaims against Osmotica asserting Osmotica has infringed nine Company patents under 35 U.S.C. §§ 271(a), (b), and/or (c) and 35 U.S.C. § 271(e)(2)(A) and seeking various forms of relief, including damages, treble damages, injunctive relief, and an order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of any approval of Osmotica’s NDA for Osmolex ER™ be a date that is not earlier than the latest expiration date of the Company patents involved in the lawsuit. This action is ongoing, but was stayed on May 23, 2019 at the parties’ joint request. On March 13, 2018, the FDA’s New Paragraph IV Certifications list was updated to reflect that an ANDA seeking authorization from the FDA to manufacture, use, or sell a generic version of GOCOVRI (amantadine) extended release capsules, containing one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“paragraph IV certification”), was submitted to the FDA on January 16, 2018, and has been accepted for filing. Subsequent to this date, the Company received a letter from attorneys representing Sandoz, Inc. (“Sandoz”) dated March 29, 2018, notifying it that Sandoz filed an ANDA for Amantadine Extended-Release Capsules, 137 mg that contains paragraph IV certifications seeking to obtain approval to engage in the commercial manufacture, use or sale of Amantadine Extended-Release Capsules, 137 mg before the expiration of U.S. Patent Nos. 8,389,578; 8,741,343; 8,796,337; 8,889,740; 8,895,614; 8,895,615; 8,895,616; 8,895,617; 8,895,618; 9,867,791; 9,867,792; 9,867,793; and 9,877,933. On May 10, 2018, Adamas Pharma, LLC, a wholly-owned subsidiary of the Company, filed a lawsuit against Sandoz alleging infringement of these patents against Sandoz in the United States District Court for the District of New Jersey. On February 7, 2019, Adamas Pharma, LLC amended its complaint in this case to also allege infringement of U.S. Patent No. 10,154,971. On December 30, 2019, Adamas Pharma, LLC entered into a definitive agreement (the “Settlement Agreement”) with Sandoz pursuant to which the parties agreed to end the lawsuit and dismiss it without prejudice, and the Court dismissed the lawsuit on January 6, 2020. Pursuant to the Settlement Agreement, Adamas Pharma, LLC grants Sandoz a license to make, use, sell, offer to sell and import a generic version of GOCOVRI (amantadine) extended release capsules (including for any new indications approved under the GOCOVRI NDA), effective as of March 4, 2030, or earlier in certain circumstances typical for such agreements. The Settlement Agreement contains provisions that may accelerate the license date, including if unit sales of GOCOVRI for the 12-month period ending July 31, 2025 or any subsequent 12-month period decline by a specified percentage below GOCOVRI unit sales for the year ending December 31, 2019. The Company and Adamas Pharma LLC intend to continue to enforce the patents associated with GOCOVRI. On April 1, 2019, the Company was served with a complaint filed in the United States District Court for the Northern District of California (Case No. 3:18-cv-03018-JCS) against the Company and several Allergan entities alleging violations of Federal and state false claims acts (“FCA”) in connection with the commercialization of Namenda XR and Namzaric by Allergan. The lawsuit is a qui tam complaint brought by a named individual, Zachary Silbersher, asserting rights of the Federal government and various state governments. The lawsuit was originally filed in May 2018 under seal, and the Company became aware of the lawsuit when it was served. The complaint alleges that patents held by Allergan and the Company covering Namenda XR and Namzaric were procured through fraud on the United States Patent and Trademark Office and that these patents were asserted against potential generic manufacturers of Namenda XR and Namzaric to prevent the generic manufacturers from entering the market, thereby wrongfully excluding generic competition resulting in an artificially high price being charged to government payors. The Company’s patents in question were licensed exclusively to Forest. The complaint includes a claim for damages of “potentially more than $2.5 billion dollars,” treble damages “under the federal FCA and most of the State FCAs,” and “statutory penalties that can be assessed for each false claim.” This action is ongoing. The federal and state governments have declined to intervene in this action. To the Company’s knowledge, the individual plaintiff is pursuing the lawsuit in his individual capacity. The Company believes it has strong factual and legal defenses and intends to defend itself vigorously. The Company is in the early stages of this litigation. On May 13, 2019, a putative class action lawsuit alleging violations of the federal securities laws was filed in California Superior Court for the County of Alameda (Case No. RG1901875). The lawsuit alleges violations of the Securities Act of 1933 by the Company and certain of the Company’s current and former directors and officers for allegedly making false statements and omissions in the registration statement and prospectus filed by the Company in connection with our January 24, 2018, secondary public offering of common stock. On December 10, 2019, another putative class action lawsuit alleging violations of the federal securities laws was filed in federal court in the Northern District of California (Case No. 4:19-cv-08051). This lawsuit alleges violations of the Securities Act of 1934 by the Company and certain of the Company’s former officers. Other similar cases may be filed in the future. In both of these actions, Plaintiffs seek unspecified monetary damages and other relief. These actions are ongoing. The Company believes it has strong factual and legal defenses to both actions and intends to defend itself vigorously. From time to time, the Company may be party to legal proceedings, investigations, and claims in the ordinary course of its business. Other than the matters described above, the Company is not currently party to any material legal proceedings. |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | LONG-TERM DEBT Royalty-Backed Loan Agreement In May 2017, the Company, through a new wholly-owned subsidiary, Adamas Pharma, LLC, entered into a Royalty-Backed Loan with HCRP, whereby the Company initially borrowed $35 million, followed by an additional $65 million received in the fourth quarter 2017 upon FDA’s recognition in the Orange Book of seven-year orphan drug exclusivity, which GOCOVRI earned upon approval on August 24, 2017. Principal and interest will be payable quarterly from the proceeds of a 12.5% royalty on U.S. net sales of GOCOVRI and up to $15 million of the Company’s annual royalties from Allergan on U.S. net sales of Namzaric starting in May 2020, pursuant to the Company’s license agreement with Allergan. The royalty rate on net sales of GOCOVRI will drop to 6.25% after the principal amount of the loan has been repaid in full, until the Company has made total payments of 200% of the funded amounts. The Company may elect to voluntarily prepay the loan at any time, or may be required to prepay subject to specified prepayment trigger events as described below, in which case the amount due will be 200% of the funded amounts, less total payments made to date. Royalty rates are subject to increase to 17.5% and 22.5% if total principal and interest payments have not reached minimum specified levels at measurement dates on December 2021 and December 2022, respectively. Under the terms of the loan, HCRP has recourse to Adamas Pharma, LLC, not the Company. The loan agreement matures in December 2026 but as the repayment of the loan amount is contingent upon the sales volumes of GOCOVRI and royalties from Allergan, the repayment term may be shortened depending on the actual sales of GOCOVRI and actual royalties received from Allergan. The loans bear interest at an annual rate of 11% on the outstanding principal amount and includes an interest-only period until the interest payment date following the ninth full calendar quarter after the $65 million additional loan received in the fourth quarter 2017. To the extent that royalties are insufficient to pay interest in full during the first nine quarters of the loan, any unpaid portion of the quarterly interest payment will be added to the principal amount of the loans. In connection with the Royalty-Backed Loan, in 2017 the Company paid HCRP a lender expense amount of $0.4 million and incurred additional debt issuance costs totaling $0.8 million. The lender expense and additional debt issuance costs have been recorded as a debt discount and are being amortized and recorded as interest expense over the estimated term of the loan using the effective interest method. The Company recorded interest expense, including amortization of the debt discount, related to the Royalty-Backed Loan, of $15.0 million, $19.1 million, and $4.6 million for the twelve months ended December 31, 2019, 2018, and 2017, respectively. Interest expense over the life of the Royalty-Backed Loan includes an annual interest rate of 11% on the outstanding principal, a royalty rate of 6.25% on net sales of GOCOVRI after the principal amount is paid, and amortization of the debt discount. The effective interest rate as of December 31, 2019 on the amounts borrowed under the Royalty-Backed Loan, including the amortization of the debt discount, was 13.4%. The assumptions used in determining the expected repayment term of the loan and amortization period of the debt discount require that the Company make estimates that could impact the short and long-term classification of these costs, as well as the period over which these costs will be amortized and the effective interest rate. The Company may be required to make mandatory prepayments of the borrowings under the Royalty-Backed Loan upon the occurrence of specified prepayment trigger events, including: (1) the occurrence of any event of default or (2) the occurrence of a change in control. Upon the prepayment of all or any of the outstanding principal balance, the Company shall pay, in addition to such prepayment, a prepayment premium. As HCRP, as the holder of the loans, may exercise the option to require prepayment by the Company, the prepayment premium is considered to be an embedded derivative which is required to be bifurcated from its host contract and accounted for as a separate financial instrument. The valuation of the embedded derivative is described further in Note 3. Payment obligations under the Royalty-Backed Loan are as follows (in thousands): December 31, 2019 2018 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (63,217) (78,261) Less: Payments made (9,068) (2,618) Carrying value of loans payable $ 127,715 $ 119,121 Less: Current portion of long-term debt (2,041) (1,664) Non-current portion of long-term debt $ 125,674 $ 117,457 The estimated fair value of the long-term debt, as measured using Level 3 inputs, approximates $108.1 million as of December 31, 2019. The estimated fair value was calculated in the same methodology as the valuation of the embedded derivative as described further in Note 3. |
Convertible Preferred Stock
Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2019 | |
Temporary Equity Disclosure [Abstract] | |
Convertible Preferred Stock | CONVERTIBLE PREFERRED STOCKThe Company’s amended and restated certificate of incorporation filed on April 15, 2014, authorizes 5,000,000 shares of preferred stock, of which there were no shares outstanding as of December 31, 2019 and 2018. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Common Stock The amended and restated certificate of incorporation authorizes the Company to issue 100,000,000 shares of common stock. Common stockholders are entitled to dividends as and when declared by the board of directors, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. Each share of common stock is entitled to one vote. Public Offering In January 2018, the Company completed a follow-on public offering of 3,450,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 450,000 shares of common stock, at an offering price of $41.50 per share. Proceeds from the follow-on public offering were approximately $134.3 million, net of underwriting discounts and offering-related transaction costs. Sales Agreement In November 2019 the Company entered into a sales agreement (“Sales Agreement”) with Cowen and Company, LLC (“Cowen”), as sales agent, pursuant to which the Company may, from time to time, issue and sell at its option, shares of the Company’s common stock for an aggregate offering price of up to $50.0 million under an at-the-market offering (“ATM Offering”). Sales of the common stock, if any, will be made pursuant to a shelf registration statement that was declared effective by the Securities and Exchange Commission (“SEC”) on December 2, 2019. Cowen is acting as sole sales agent for any sales made under the Sales Agreement and the Company will pay Cowen a commission of up to 3% of the gross proceeds. The Company’s common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices may vary. The Company is not obligated to make any sales of shares of common stock under the Sales Agreement. Unless otherwise terminated earlier, the Sales Agreement continues until all shares available under the Sales Agreement have been sold. As of December 31, 2019, no shares have been sold under the Sales Agreement. Shares Reserved for Future Issuance Shares of the Company’s common stock reserved for future issuance are as follows: December 31, 2019 2018 Common stock awards issued and outstanding 6,874,633 5,949,436 Authorized for future issuance under 2014 Equity Incentive Plan 2,376,613 1,814,179 Authorized for future issuance under 2016 Inducement Plan 236,269 512,440 Employee stock purchase plan 926,943 847,105 Total 10,414,458 9,123,160 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Stock Compensation Plans In October 2002, the Company established its 2002 Employee, Director, and Consultant Stock Plan and in December 2007, the Company established its 2007 Stock Plan. No further grants were then made under the 2002 Plan. In February 2014, the Company’s board of directors adopted, and in March 2014 the Company’s stockholders approved, the 2014 Equity Incentive Plan (the “2014 Plan”), which became effective on the completion of the IPO. No further grants were then made under the 2007 Plan. Under the 2014 Plan, 1,993,394 shares of the Company’s common stock were made available for issuance which included all shares that, as of the effective time, were reserved for issuance pursuant to the 2007 Plan, and is subject to further increase for shares that were subject to outstanding options under the 2007 Plan and the 2002 Plan as of the effective time that thereafter expire, terminate, or otherwise are forfeited or reacquired. The number of shares of the Company’s common stock reserved for issuance pursuant to the 2014 Plan will automatically increase on the first day of each fiscal year for a period of up to 10 years, commencing on the first day of the fiscal year following 2014, in an amount equal to 4% of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding fiscal year, or a lesser number of shares as determined by the Company’s board of directors. On January 1, 2019, the common stock available for issuance under the 2014 Plan increased by 1,097,374 shares. As of December 31, 2019, the number of shares available for issuance under the 2014 Plan was 2,376,613. Options granted under the 2014 Stock Plan may have terms of up to ten ten four In March 2016, the Company’s board of directors approved the 2016 Inducement Plan (the “Inducement Plan”) under which 450,000 shares of the Company’s common stock were made available for issuance. In each of January 2017, November 2017, and March 2019, an amendment to the Inducement Plan was approved to increase the number of shares available for issuance an additional 450,000 shares, for a total of 1,350,000 shares, resulting in a total of 1,800,000 shares of common stock issuable under the Inducement Plan. As of December 31, 2019, the number of shares available for issuance under the Inducement Plan was 236,269. Options granted under the Inducement Plan may have terms of up to ten ten four Stock Option Activity Stock option activity under all of the Company’s stock compensation plans is summarized as follows: Outstanding Options Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (thousands) Number of Shares Weighted Average Exercise Price Stock Options Balances, December 31, 2018 5,301,066 $ 14.98 Options granted 1,721,508 6.48 Options exercised (184,626) 1.59 Options forfeited (605,595) 18.69 Options expired (715,669) 17.34 Balances, December 31, 2019 5,516,684 $ 12.06 5.43 $ 2,015 Vested and expected to vest, December 31, 2019 5,334,042 $ 12.09 5.35 $ 2,015 Exercisable, December 31, 2019 3,487,330 $ 12.54 3.97 $ 2,015 The aggregate intrinsic value of options outstanding, vested and expected to vest, and exercisable were calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock as of December 31, 2019 of $3.79. The intrinsic value of options exercised, calculated as the difference between the exercise price and the fair value of the Company’s common stock on the date of exercise, was approximately $0.9 million, $9.2 million, and $18.1 million for the years ended December 31, 2019, 2018, and 2017, respectively. During the years ended December 31, 2019, 2018, and 2017, the Company granted stock options to employees to purchase 1,721,508, 1,289,396, and 1,439,675 shares of common stock, respectively, with a weighted-average grant date fair value of $4.01, $16.08, and $11.93, respectively. As of December 31, 2019, there was total unrecognized compensation cost related to unvested options of approximately $10.5 million. This cost is expected to be recognized over a weighted average remaining vesting period of 2.6 years. The total fair value of employee stock options vested for the years ended December 31, 2019, 2018, and 2017 was $9.6 million, $12.1 million and $10.6 million, respectively. Restricted Stock Unit Activity Restricted stock unit activity under all of the Company’s stock compensation plans is summarized as follows: Outstanding Units Weighted-Average Restricted Stock Units Number of Shares Unvested, December 31, 2018 648,370 $ 16.57 Granted 1,185,093 5.61 Vested (151,288) 16.94 Forfeited (324,226) 13.12 Unvested, December 31, 2019 1,357,949 $ 7.79 The aggregate intrinsic value of RSUs outstanding on December 31, 2019 was $5.1 million based on the fair value of the Company’s common stock on that date. The aggregate intrinsic value of RSUs vested for the years ended December 31, 2019, 2018, and 2017 was $1.0 million, $2.3 million, and $1.2 million, respectively. As of December 31, 2019, there was total unrecognized compensation cost related to unvested RSUs of approximately $7.7 million. This cost is expected to be recognized over a weighted average remaining vesting period of 2.4 years. Employee Stock Purchase Plan In February 2014, the Company’s board of directors adopted and, in March 2014, the Company’s stockholders approved, the 2014 Employee Stock Purchase Plan (the “ESPP”), which became effective on the completion of the Company’s IPO. The ESPP authorized the issuance of 262,762 shares. Under the ESPP, employees, subject to certain restrictions, may purchase shares of common stock at 85% of the fair market value at either the beginning of the offering period or the date of purchase, whichever is less. Purchases are limited to the lesser of 15% of each employee’s eligible annual compensation or $25,000. Through the end of 2019, the Company has issued a total of 423,826 shares under the ESPP. The number of shares available for future issuance under the plan were 926,943 at December 31, 2019. Beginning January 1, 2015 and continuing through and including January 1, 2024, the amount of common stock reserved for issuance under the ESPP will increase annually on that date by the lesser of (i) one percent (1%) of the total number of shares of common stock outstanding on such December 31, (ii) 520,000 shares of common stock, or (iii) a number of shares as determined by the board of directors prior to the beginning of each year, which shall be the lesser of (i) or (ii) above. On January 1, 2019, the common stock available for issuance under the ESPP increased by 274,344 shares. Stock-Based Compensation Expense The following table reflects stock-based compensation expense recognized for the years ended December 31, 2019, 2018, and 2017 (in thousands): Years Ended December 31, 2019 2018 2017 Research and development $ 1,732 $ 2,822 $ 3,597 Selling, general and administrative 11,120 12,964 9,770 Total stock-based compensation expense $ 12,852 $ 15,786 $ 13,367 Stock-based compensation of $208,000, $202,000, and $39,000 was capitalized into inventory for the twelve months ended December 31, 2019, 2018, and 2017. Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. The Company’s method of valuation for share-based awards is based on the Black-Scholes model. The Company’s determination of fair value of share-based payment awards on the date of grant using an option-pricing model is affected by the Company’s stock price as well as assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to the Company’s expected stock price volatility over the term of the awards, and actual and projected employee stock option exercise behaviors. A description of the assumptions follows: • The expected stock price volatility assumption was determined by examining the historical volatilities of a group of industry peers, as well as taking into consideration the Company’s own historical volatility since its IPO in 2014. • The risk-free interest rate is based on the U.S. Treasury zero-coupon issues with remaining terms similar to the expected term on the options. • The expected term of the options granted represents the average period the stock options are expected to remain outstanding. The Company has elected to use the “simplified method” for estimating the expected term, which is calculated as the mid-point between the vesting period and the contractual term of the options. • The expected dividend yield assumption was based on the fact that the Company has never paid cash dividends and currently has no intention to pay cash dividends. As stock-based compensation expense recognized in the Consolidated Statement of Operations for fiscal years 2019, 2018, and 2017 is based on awards ultimately expected to vest, each has been reduced for estimated forfeitures, based on historical experience. The Company estimated the fair value of employee stock options and ESPP shares on the date of grant using the Black-Scholes model with the following weighted-average assumptions: Years Ended December 31, 2019 2018 2017 Stock Options Expected price volatility 65% - 69% 67% - 70% 68% - 70% Risk-free interest rate 1.52% - 2.58% 2.27% - 3.06% 1.83% - 2.17% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 5.50 - 6.25 Dividend yield — — — Years Ended December 31, 2019 2018 2017 Employee Stock Purchase Plan Expected price volatility 53% - 56% 62% - 64% 51% - 71% Risk-free interest rate 1.60% - 2.35% 2.10% - 2.56% 0.60% - 1.45% Expected term (in years) 0.50 0.50 0.50 Dividend yield — — — Stock-based compensation expense related to employee stock options for the years ended December 31, 2019, 2018, and 2017 was $9.4 million, $12.7 million, and $11.2 million, respectively. Stock-based compensation expense related to the ESPP plan for the years ended December 31, 2019, 2018, and 2017 was $0.4 million, $0.6 million, and $0.3 million, respectively. Stock-based compensation expense related to restricted stock units was $3.1 million, $2.3 million, and $1.3 million for the years ended December 31, 2019, 2018 and 2017, respectively. Included in stock-based compensation expense for the year ended 2019 was expense of approximately $2.2 million recognized as a result of the modification of certain stock options and restricted stock units associated with the termination of employment in September 2019 of the Company’s Chief Executive Officer and notification of retirement in August 2019 of the Company’s Chief Financial Officer. Non-Employee Stock-Based Compensation The Company granted no options to purchase common stock and no restricted stock units to consultants during the years ended 2019 and 2018. During the year ended 2017, the Company granted 5,000 options and 12,437 restricted stock units to consultants. These restricted stock units and options are granted in exchange for consulting services to be rendered and are measured and recognized as they are earned. The Company believes that the estimated fair value of the restricted stock units and stock options is more readily measurable than the fair value of the services rendered. The Company estimated the fair value of non-employee stock options using the Black-Scholes model with the following weighted-average assumptions: Years Ended December 31, 2019 2018 2017 Expected price volatility — 69% - 74% 68% - 80% Risk-free interest rate — 2.32% - 2.45% 1.94% - 2.36% Expected term (in years) — 6.00 - 9.50 6.00 - 9.75 Dividend yield — — — Compensation expense related to non-employee restricted stock units and options for years ended December 31, 2019, 2018, and 2017 was approximately zero, $0.2 million, and $0.6 million, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES Loss before benefit for income tax is summarized as follows (in thousands): Years Ended December 31, 2019 2018 2017 United States $ (105,186) $ (130,999) $ (91,220) International — — — Total $ (105,186) $ (130,999) $ (91,220) The benefit for income taxes is summarized as follows (in thousands): December 31, 2019 2018 2017 Current: Federal $ — $ — $ (1,730) State — — — Benefit for income taxes $ — $ — $ (1,730) The benefit for income taxes differs from the amount computed by applying the federal income tax rate of 21% to pretax loss from operations as a result of the following: December 31, 2019 2018 2017 Statutory federal income tax rate $ (22,079) $ (27,510) $ (31,927) State income taxes, net of federal tax benefits (8,473) (10,296) (5,041) Tax credits (1,398) (2,587) (2,306) Impact of federal rate change — — 24,907 Change in statutory rates — 34 (1,440) Stock compensation 2,648 (569) (2,558) Nondeductible compensation 278 — — State net operating losses — — 633 Other 198 798 — Change in valuation allowance 28,826 40,130 16,002 Income tax benefit $ — $ — $ (1,730) Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2019 2018 Deferred tax assets Net operating loss carryforwards $ 99,449 $ 75,143 Research and development tax credits 20,174 18,776 Accruals and reserves 7,004 4,655 Stock compensation 9,291 8,662 Depreciation and amortization 1,108 1,437 Lease liabilities 2,889 — Other (rate change) — 77 Gross deferred tax assets 139,915 108,750 Less: Valuation allowance (137,576) (108,750) Net deferred tax assets 2,339 — Deferred tax liabilities Right of use assets (2,339) — Net deferred tax liabilities (2,339) — Net deferred taxes $ — $ — The deferred income tax assets have been fully offset by a valuation allowance, as realization is dependent on future earnings, if any, the timing and amount of which are uncertain. The net valuation allowance increased by $28.8 million and $40.1 million for the years ended December 31, 2019 and 2018, respectively. The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realization of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood, and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. The Tax Act repealed corporate alternative minimum tax (“AMT”) for tax years beginning after December 31, 2017, and provides that existing AMT credit carryovers are refundable beginning in 2018 through 2022. The Company has approximately $1.7 million of AMT credit carryovers that are to be fully refunded by 2022 and therefore the deferred tax asset was reclassed to an income tax receivable in 2017. As for the remaining deferred tax assets, the Company does not believe that it is more likely than not that the deferred tax assets will be realized; accordingly, a full valuation allowance has been established and no deferred tax asset is shown in the accompanying balance sheets. As of December 31, 2019, and 2018, the Company had federal net operating loss carryforwards of approximately $354.4 million and $271.6 million, respectively, available to reduce future taxable income. The Company also had state net operating loss carryforwards of approximately $325.8 million and $236.2 million as of December 31, 2019 and 2018, respectively. The federal net operating loss carryforward begins expiring in 2024, and state net operating loss carryforward begins expiring in 2028. The Company has federal research and development tax credit carryforwards of approximately $6.6 million. If not utilized, the carryforwards will begin expiring in 2023. The Company has state research and development credit carryforwards of approximately $4.3 million which do not expire. The Company also has orphan drug credit carryforwards of $14.4 million which begin to expire in 2035. Under federal and similar state tax statutes, changes in the Company’s ownership may limit its ability to use its available net operating loss and tax credit carryforwards. The annual limitation, as a result of a change of control, may result in the expiration of net operating losses and credits before utilization. The Company’s ability to use its remaining net operating loss and tax credit carryforwards may be further limited if the Company experiences a Section 382 ownership change in connection with future changes in its stock ownership. The Company has completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards through April 2018 and found that there is no forfeiture of the Company’s attributes. Uncertain Tax Positions The total amounts of unrecognized tax benefits for the years ended December 31, 2019, 2018, and 2017 were $5.1 million, $4.7 million, and $4.0 million, respectively. If recognized, none of the unrecognized tax benefits would affect the effective tax rate. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2019 2018 2017 Balance at the beginning of the year $ 4,697 $ 4,034 $ 3,188 Additions based on prior period tax positions — 220 43 Additions based on current period tax positions 368 443 803 Balance at the end of the year $ 5,065 $ 4,697 $ 4,034 The Company’s policy is to account for interest and penalties as income tax expense. The Company accrued no interest related to unrecognized tax benefits during the years ended December 31, 2019, 2018, and 2017. The Company files income tax returns in the U.S. federal jurisdiction, Pennsylvania, California, other state jurisdictions, and India. The Company is subject to U.S. federal income tax examination for the calendar years ending 2002 through 2019 due to net operating losses that have been carried forward for tax purposes. Additionally, the Company is subject to state income tax examinations for the 2006 through 2019 calendar years due to net operating losses that are being carried forward for tax purposes. The Company is subject to audit by the Indian tax authorities from 2014 onward. The Company is not currently under audit in any major tax jurisdiction. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act made broad and complex changes to the U.S. tax code, including, but not limited to, reducing the U.S. federal corporate tax rate from 35 percent to 21 percent for tax years beginning after December 31, 2017. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | NET LOSS PER SHARE For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares outstanding due to the Company’s net loss position. The following table presents the calculation of the basic and diluted net loss per share (in thousands, except per share data): Years Ended December 31, 2019 2018 2017 Net loss attributable to common stockholders, basic and diluted $ (105,186) $ (130,999) $ (89,490) Weighted average common shares used in calculating net loss per common share, basic and diluted 27,677 26,886 22,558 Net loss per share attributable to common stockholders, basic and diluted $ (3.80) $ (4.87) $ (3.97) The following total outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented, because including them would have been anti-dilutive (in thousands): December 31, 2019 2018 2017 Options to purchase common stock 5,517 5,301 5,138 Restricted stock units 1,358 648 427 Total 6,875 5,949 5,565 |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (Unaudited) | QUARTERLY FINANCIAL INFORMATION (UNAUDITED) The following table represents certain unaudited quarterly information for the eight quarters ended December 31, 2019. This data has been derived from unaudited consolidated financial statements that, in the opinion of the Company’s management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of such information when read in conjunction with the Company’s annual audited consolidated financial statements and notes thereto appearing elsewhere in this report. These operating results are not necessarily indicative of results for any future period (in thousands, except per share data): Year Ended December 31, 2019 First Quarter Second Quarter Third Quarter Fourth Quarter Total revenues $ 11,665 $ 12,691 $ 13,933 $ 16,348 Gross profit(1) 11,252 12,006 13,004 15,906 Net loss (29,658) (24,871) (27,582) (23,075) Net loss per share, basic and diluted (1.08) (0.90) (0.99) (0.83) Year Ended December 31, 2018 First Quarter Second Quarter Third Quarter Fourth Quarter Total revenues $ 2,553 $ 7,565 $ 10,613 $ 13,315 Gross profit(1) 2,528 7,492 10,513 12,880 Net loss (34,971) (33,993) (33,152) (28,883) Net loss per share, basic and diluted (1.35) (1.26) (1.22) (1.06) (1) Gross profit is computed by subtracting cost of product sales from product sales. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Use of Estimates | Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition and variable consideration, lease assets and liabilities, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, inventory, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates. |
Liquidity | Liquidity During the last three fiscal years, the Company has funded its operations primarily through a Royalty-Backed Loan with HealthCare Royalty Partners (“HCRP”), sales of GOCOVRI, and sales of its common stock. In 2017, the Company entered into a Royalty-Backed Loan with HCRP, whereby the Company borrowed a total of $100.0 million. The Company made GOCOVRI available for physician and patient use in the fourth quarter of 2017, with a full commercial launch in January 2018. In January 2018, the Company completed a follow-on public offering of its common stock from which proceeds raised were approximately $134.3 million, net of underwriting discounts, commissions, and offering-related transaction costs. Prior to the generation of revenue from GOCOVRI, the Company had not generated any commercial revenue from the sale of its products. As of December 31, 2019, the Company had $132.6 million of cash, cash equivalents, and investments, which management believes will be sufficient to fund its projected operating requirements, including commercialization of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease and operations related to the continued development of ADS-5102 for other indications including MSW, for at least 12 months from the issuance of this annual report on Form 10-K. However, it is possible that the Company will not achieve the progress it expects, because revenues from GOCOVRI may be less than anticipated and the actual costs and timing of drug development, particularly clinical studies, and regulatory approvals are difficult to predict, subject to substantial risks and delays, and often vary depending on the particular indication and development strategy. |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory consists of raw materials, work-in-process, and GOCOVRI finished goods. Raw materials and work-in-process that may be utilized for both commercial and clinical programs are identical and, as a result, the inventory has an “alternative future use” as defined in authoritative guidance and are included in inventory. Amounts in inventory associated with clinical development programs are charged to research and development expense when the product enters the research and development process and can no longer be used for commercial purposes and, therefore, does not have “alternative future use”. Costs include active pharmaceutical ingredient (API), third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. If the Company identifies excess, obsolete or unsalable product, the Company will write down its inventory to net realizable value in the period it is identified. During 2019 and 2018, the Company recorded a $0.9 million and $0.2 million write-down of GOCOVRI inventory, respectively. No such charges were recorded in 2017. The Company begins capitalizing costs as inventory when the product candidate receives regulatory approval. Prior to regulatory approval, inventory costs related to product candidates are recorded as research and development expense. The Company received FDA approval for GOCOVRI on August 24, 2017, and began capitalizing inventory manufactured at the FDA approved location, after FDA approval. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of highly liquid investments with original maturities, when purchased, of less than three months. |
Investments | Investments The Company classifies its investments as “available-for-sale.” In general, these investments are free of trading restrictions. The Company carries these investments at fair value, based on quoted market prices or other readily available market information. Quoted market prices for U.S. government and corporate bonds include both principal and accrued interest components. Unrealized gains and losses are included in accumulated other comprehensive income, which is reflected as a separate component of stockholders’ equity in its Consolidated Balance Sheets. Gains and losses are recognized when realized in its Consolidated Statements of Operations. When the Company determines that an other-than-temporary decline in fair value has occurred, the amount of the decline that is related to a credit loss is recognized in income. Gains and losses are determined using the specific identification method. The Company considers all marketable debt securities with a maturity of less than one year to be short-term investments, with all others considered to be long-term investments. All of the Company’s available-for-sale securities are subject to a periodic impairment review. The Company recognizes an impairment charge when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary. Factors considered in determining whether a loss is temporary include the length of time and extent to which the investments’ fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, extent of the loss related to credit of the issuer, the expected cash flows from the security, its intent to sell or hold the security, and whether or not the Company will be required to sell the security before the recovery of its amortized cost. |
Consolidation | Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. |
Segment | SegmentsIn accordance with ASC 280-10-50, Segment Reporting, operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in one reportable segment: the development and commercialization of therapeutics targeting chronic disorders of the central nervous system. |
Revenue Recognition and Cost of Product Sales | Revenue Recognition Effective January 1, 2018, the Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , using the full retrospective transition method. The Company recognizes revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity 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) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. Product sales The Company’s product sales consist of U.S. sales of GOCOVRI. GOCOVRI was approved by the FDA on August 24, 2017, and the Company commenced shipments of GOCOVRI to a specialty pharmacy during October 2017. The Company sells its products principally to a specialty pharmacy and certain specialty distributors (each a “Customer” or collectively its “Customers”). These agreements with its Customers provide for transfer of title to the product at the time the product has been delivered to and accepted by the Customer. The Customer subsequently dispenses product directly to a patient. In addition, except for limited circumstances, the Customer has no right of product return to the Company. The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. The Company has determined that the delivery of its product to Customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its Customers. The trade payment terms with its Customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. The Company considers the effects of items which can decrease the transaction price such as variable consideration and consideration payable to a Customer or payer. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition: Distribution Fees : Distribution fees include fees paid to the Company’s Customers for data and prompt payment discounts. Distribution fees are recorded based on contractual terms. Rebates : Rebates include mandated discounts under the Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, TRICARE Retail Pharmacy Refunds Program (TRICARE), and commercial contracts. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements with benefit providers. Rebates are estimated based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on data received from the specialty pharmacy and specialty distributor. The Company uses the expected-value method for estimating rebates and estimates are adjusted quarterly to reflect actual experience. Chargebacks : Chargebacks are discounts that occur when Healthcare Providers purchase directly from a Customer. Healthcare Providers, which currently consist of Public Health Service institutions, non-profit clinics, government entities, group purchasing organizations, and health maintenance organizations, generally purchase the product at a discounted price. The Customer, in turn, charges back to the Company the difference between the price initially paid by the Customer and the discounted price paid by the Healthcare Providers to the Customer. The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer. Product Returns : Consistent with industry practice, the Company offers limited product return rights and generally allows for the return of product that is damaged or defective, and within a few months prior to and up to a few months after the product expiration date. The Company does not allow product returns for product that has been dispensed to a patient. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, prescription trends, and other relevant factors. Product returns have been insignificant to date and are expected to be immaterial in the future. Medicare Part D Coverage Gap : Medicare Part D coverage gap is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States, which mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Funding of the coverage gap is generally invoiced and paid in arrears. The impact of the Medicare Part D coverage gap is estimated using the expected-value method based on an amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters and is adjusted quarterly based on actual experience. Co-payment Assistance : The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. Co-payment assistance is estimated using the expected-value method based on historical program participation and estimates of program redemption using data provided by third-party administrators. Each of the above items are variable consideration, are recorded at the time of revenue recognition, and require significant estimates, judgment and information obtained from external sources. The Company determined a significant reversal of revenue would not occur in a future period for the estimates of variable consideration detailed above and, therefore, the transaction price was not reduced during the periods presented. If management’s estimates differ from actual results, the Company will record adjustments that would affect product sales in the period of adjustment. License agreement revenue The Company generates revenue from collaboration and license agreements for the development and commercialization of products. Collaboration and license agreements may include non-refundable upfront license fees, partial or complete reimbursement of research and development costs, contingent consideration milestone payments based on the achievement of defined objectives, and royalties on sales of commercialized products. Such agreements may contain various promises to customers which are generally capable of being distinct and accounted for as separate performance obligations. The Company’s duties and responsibilities under the collaboration and license agreements typically include the license or transfer of intellectual property rights, obligations to provide research and development services and related materials, and obligations to participate on certain development and/or commercialization committees with the partners. These promises may be regarded as separate performance obligations, or bundled as a single performance obligation, depending upon the nature of the arrangement. For agreements with multiple performance obligations, the Company allocates estimated revenue to each performance obligation at contract inception based on the estimated relative standalone selling price (SSP) of each performance obligation in the arrangement. Revenue allocated to each performance obligation is then recognized when the entity satisfies the performance obligation by transferring control of the promised good or service to the customer. Licenses for Intellectual Property (IP) : If the Company determines that the license for IP is distinct from the other performance obligations identified in the arrangement, revenue from non-refundable, up-front fees allocated to the license is recognized when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, judgment is applied to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : For contracts with customers that contain payments that are contingent upon achievement of a substantive milestone, at the inception of each arrangement that includes development 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 transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative SSP basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in the period of adjustment. Reimbursement of Research and Development Costs: Amounts related to research and development funding and full-time equivalent employees assigned to the license agreement are recognized over time as the related services or activities are performed, in accordance with the contract terms. Royalties : For arrangements that include sales-based royalties, and the licensed IP is deemed to be the predominant item to which the royalties relate, the Company recognizes the related royalty revenue at the later of (i) when the related sales occur, or (ii) the satisfaction or partial satisfaction of the performance obligation to which the royalty relates. Cost of Product Sales Cost of product sales consists primarily of direct and indirect costs related to the manufacturing of GOCOVRI products sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs. Cost of product sales may also include period costs related to certain inventory manufacturing services, inventory adjustment charges, as well as manufacturing variances. In connection with the FDA approval of GOCOVRI on August 24, 2017, the Company began capitalizing inventory manufactured at the FDA approved location starting in August 2017. Prior to receiving regulatory approval for GOCOVRI from the FDA, the Company expensed all costs incurred in the manufacture of GOCOVRI as research and development. |
Concentration of Risk | Concentration of Risk Credit Risk Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and short and long-term investments. Cash, cash equivalents, and investments are deposited with financial institutions or invested in security issuers that management believes are credit worthy. Deposits may, at times, exceed the amount of insurance provided on such deposits. Risks associated with cash, cash equivalents, and investments are mitigated by the Company’s investment policy which defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. Major Customers The Company has entered into distribution agreements with a specialty pharmacy and certain limited specialty distributors. For the years ended December 31, 2019 and 2018, the Company’s largest customer represented approximately 98% and 99% of the Company’s product revenue, respectively, and approximately 96% and 99% of the Company’s accounts receivable balance at December 31, 2019 and 2018, respectively. Major Suppliers The Company does not currently have any of its own manufacturing facilities, and therefore it depends on an outsourced manufacturing strategy for the production of GOCOVRI for commercial use and for the production of its product candidates for clinical trials. The Company has contracts in place with one third-party manufacturer that is approved for the commercial production of GOCOVRI and one third-party supplier that is approved for GOCOVRI’s active pharmaceutical ingredient. Although there are potential sources of supply other than the Company’s existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. |
Accounts Receivable, net | Accounts Receivable, net The Company’s accounts receivable balance consists of amounts due from sales of GOCOVRI. Receivables from sales of GOCOVRI are recorded net of allowances which generally include chargebacks, doubtful accounts, and discounts. Allergan receivables are for research and development funding and full-time equivalent employees assigned to the Allergan license agreement, as well as for reimbursement of external costs, recorded as contra-expense, associated with supporting prosecution and litigation of intellectual property rights. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations in the period realized. Estimated useful lives by major asset category are as follows: Useful Lives Computer equipment and software 3 years Equipment 5 years Furniture and fixtures 10 years |
Leases | Leases The Company determines if an arrangement is, or contains, a lease at inception. An arrangement is, or contains, a lease if it conveys the right to control the use of identified property, plant or equipment (i.e., an identified asset) for a period of time in exchange for consideration. The Company’s arrangements determined to be or contain a lease include explicitly or implicitly identified assets where the Company has the right to substantially all of the economic benefits of the assets and has the ability to direct how and for what purpose the assets are used during the lease term. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term and any amounts probable of being owed under a residual value guarantee (if applicable). In determining |
Accounting for Long-Lived Assets | Accounting for Long-Lived AssetsThe Company reviews its long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by the comparison of the carrying amount to the future net cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. |
Clinical Trial Accruals | Clinical Trial Accruals The Company’s clinical trial accruals are based on estimates of patient enrollment and related activities at clinical investigator sites, as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical trials on the Company’s behalf. The Company estimates clinical trial expenses based on the estimated services performed pursuant to these contracts, as provided by the CRO. These estimates are reviewed for reasonableness by the Company’s internal clinical personnel. The Company monitors patient enrollment levels and related activities using available information; however, if the Company underestimates activity levels associated with various studies at a given point in time, the Company could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. |
Research and Development | Research and Development Research and development (“R&D”) expenses include salaries and related compensation, contractor and consultant fees, external clinical trial expenses performed by CROs, licensing fees, acquired intellectual property with no alternative future use, and facility and administrative expense allocations. In addition, the Company funds R&D at research institutions under agreements that are generally cancelable at its option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of pre-approval inventory purchases, product formulation, chemical analysis, and the transfer and scale-up of manufacturing at facilities operated by the Company’s contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2, and Phase 3 clinical trials. These costs are a significant component of the Company’s research and development expenses. |
Long-Term Debt | Long-Term DebtLong-term debt consists of the Company’s loan agreement with HCRP. The Company accounted for the loan agreement as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the debt will be repaid. Debt issuance costs have been recorded as a debt discount in the Company’s consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the loan using the effective interest rate method. The Company must make certain assumptions and estimates, including future royalties and net product sales, in determining the expected repayment term, amortization period of the debt discount, accretion of interest expense, as well as the classification between current and long-term portions. The Company periodically assesses these assumptions and estimates, and adjusts the liabilities accordingly |
Embedded Derivatives Related to Debt Instruments | Embedded Derivatives Related to Debt Instruments Embedded derivatives that are required to be bifurcated from their host contract are evaluated and valued separately from the debt instrument. Under the Company’s loan agreement with HCRP, upon the occurrence of a default or a change in control, the Company may be required to make mandatory prepayments of the borrowings. The prepayment premium is considered an embedded derivative, as the holder of the loans may exercise the option to require prepayment by the Company. Further, in the event of a regulatory change that results in a material adverse effect on HCRP’s rate of return, the Company shall pay directly to HCRP an amount that compensates HCRP for such reduction. The embedded derivative is presented as a component of other non-current liabilities. The Company will remeasure the embedded derivatives each reporting period and report changes in the estimated fair value as gains or losses in interest and other income, net, in the consolidated statement of operations. |
Fair Value of Financial Instruments | Fair Value of Financial InstrumentsThe carrying value of the Company’s cash and cash equivalents, short-term investments, accounts receivable, long-term investments and other current assets, other assets, accounts payable, accrued liabilities approximate fair value due to the short-term nature or determinable value of these items. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company follows the provisions of ASC 740, Income Taxes, under which it assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. |
Basic and Diluted Net Loss Per Share | Basic and Diluted Net Loss Per Share Basic net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common shares outstanding and dilutive common stock equivalents outstanding during the period. Common stock equivalents are equity awards granted under the Company’s stock awards plans and are calculated under the treasury stock method. Common equivalent shares from unexercised stock options and unvested restricted stock units are excluded from the computation when there is a loss as their effect is anti-dilutive, or if the exercise price of such options is greater than the average market price of the stock for the period. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation of stock options and employee stock purchase plan shares by estimating the fair value of stock-based awards using the Black-Scholes option-pricing model. The Company accounts for stock-based compensation of restricted stock units granted to employees based on the closing price of the Company’s common stock on the date of grant. The fair value of stock-based awards, net of estimated forfeitures, is recognized and amortized over the applicable vesting period. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Pronouncements Adopted in 2019 In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). The authoritative guidance significantly amends the current accounting for leases. Under the new provisions, all lessees will report a right-of-use asset and a liability for the obligation to make payments for all leases with the exception of those leases with a term of 12 months or less. All other leases will fall into one of two categories: (i) a financing lease or (ii) an operating lease. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842 (Leases), which amends narrow aspects of the guidance issued in the amendments in ASU 2016-02, and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows entities to recognize a cumulative-effect adjustment from the application of ASU 2016-02 to the opening balance of retained earnings in the period of adoption. Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective method as of January 1, 2019 and will not restate comparative periods. The Company elected the optional package of practical expedients, which allowed the Company to not reassess: (i) whether any expired or existing contracts are considered or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain policy elections, including a policy to not separate lease and non-lease components, which the Company did not elect for its facility and office equipment lease. The adjustments due to the adoption of Topic 842 primarily related to the recognition of an operating lease right-of-use asset and operating lease liability for the lease. The impact on the consolidated balance sheet as of January 1, 2019, was as follows (in thousands): December 31, 2018 Adjustment due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use assets $ — $ 7,566 $ 7,566 Other current liabilities 512 768 1,280 Long-term portion of operating lease liabilities — 8,643 8,643 Other non-current liabilities 3,196 (1,844) 1,352 In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Previously, accounting for share-based payments to employees was covered by ASC Topic 718 while accounting for such payments to non-employees was covered by ASC Subtopic 505-50. Under this new guidance, both sets of awards, for employees and non-employees, will essentially follow the same model, with small variations related to determining the term assumption when valuing a non-employee award as well as a different expense attribution model for non-employee awards as opposed to employee awards. This guidance is effective for fiscal years beginning after December 15, 2018. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements New Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses ; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments ; in May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief ; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses . The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842)—Effec tive Dates , which defers the effective date of ASU 2016-13 for all entities except SEC reporting companies that are not smaller reporting companies. As a smaller reporting company, this guidance is effective for fiscal years beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the timing and effect the new guidance will have on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement , which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes , which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of estimated useful lives by major asset category | Estimated useful lives by major asset category are as follows: Useful Lives Computer equipment and software 3 years Equipment 5 years Furniture and fixtures 10 years Property and equipment, net (in thousands) December 31, 2019 2018 Computer equipment and software $ 3,297 $ 3,286 Equipment 384 384 Furniture and fixtures 336 336 Leasehold improvements 1,891 1,891 5,908 5,897 Less: Accumulated depreciation and amortization (3,459) (2,245) Property and equipment, net $ 2,449 $ 3,652 |
Schedule of recently adopted accounting pronouncements | The impact on the consolidated balance sheet as of January 1, 2019, was as follows (in thousands): December 31, 2018 Adjustment due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use assets $ — $ 7,566 $ 7,566 Other current liabilities 512 768 1,280 Long-term portion of operating lease liabilities — 8,643 8,643 Other non-current liabilities 3,196 (1,844) 1,352 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis | The following table represents the fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis (in thousands): December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market $ 27,720 $ 27,720 $ — $ — Corporate debt 22,576 — 22,576 — U.S. Treasury notes 37,811 — 37,811 — Commercial paper 10,928 $ — 10,928 $ — Total assets measured at fair value $ 99,035 $ 27,720 $ 71,315 $ — Liabilities: Embedded derivative liability $ 2,157 $ — $ — $ 2,157 Total liabilities measured at fair value $ 2,157 $ — $ — $ 2,157 December 31, 2018 Total Level 1 Level 2 Level 3 Assets: Money market $ 17,789 $ 17,789 $ — $ — Corporate debt 19,792 — 19,792 — U.S. Treasury notes 131,512 — 131,512 — Commercial paper 2,961 — 2,961 — Total assets measured at fair value $ 172,054 $ 17,789 $ 154,265 $ — Liabilities: Embedded derivative liability $ 1,352 $ — $ — $ 1,352 Total liabilities measured at fair value $ 1,352 $ — $ — $ 1,352 |
Schedule of roll forward of the financial instruments classified within Level 3 of the fair value hierarchy | The following table sets forth a summary of the changes in the estimated fair value of the Company’s embedded derivative, which is measured at fair value as a Level 3 liability on a recurring basis (in thousands): Balance as of December 31, 2016 $ — Issuance of long-term debt with embedded derivative 764 Change in fair value included in interest and other income, net (294) Balance as of December 31, 2017 470 Change in fair value included in interest and other income, net 882 Balance as of December 31, 2018 1,352 Change in fair value included in interest and other income, net 805 Balance as of December 31, 2019 $ 2,157 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of amortized cost, unrealized gain and loss and the fair value of available-for-sale securities | The following table is a summary of amortized cost, unrealized gain and loss, and the fair value of available-for-sale securities as of December 31, 2019, and 2018 (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 22,582 $ 3 $ (9) $ 22,576 U.S. Treasury notes 37,789 22 — 37,811 Commercial paper 6,446 — — 6,446 Total $ 66,817 $ 25 $ (9) $ 66,833 Reported as: Short-term investments $ 66,817 $ 25 $ (9) $ 66,833 Long-term investments — — — — Total $ 66,817 $ 25 $ (9) $ 66,833 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 19,833 $ — $ (41) $ 19,792 U.S. Treasury notes 131,735 10 (233) 131,512 Commercial paper 2,961 — — 2,961 Total $ 154,529 $ 10 $ (274) $ 154,265 Reported as: Short-term investments $ 154,529 $ 10 $ (274) $ 154,265 Long-term investments — — — — Total $ 154,529 $ 10 $ (274) $ 154,265 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets (in thousands) December 31, 2019 2018 Prepaid expenses $ 2,624 $ 2,969 Prepaid clinical trial 2,710 2,299 Income tax receivable 1,259 840 Other current assets 83 763 Prepaid expenses and other current assets $ 6,676 $ 6,871 |
Schedule of property and equipment, net | Estimated useful lives by major asset category are as follows: Useful Lives Computer equipment and software 3 years Equipment 5 years Furniture and fixtures 10 years Property and equipment, net (in thousands) December 31, 2019 2018 Computer equipment and software $ 3,297 $ 3,286 Equipment 384 384 Furniture and fixtures 336 336 Leasehold improvements 1,891 1,891 5,908 5,897 Less: Accumulated depreciation and amortization (3,459) (2,245) Property and equipment, net $ 2,449 $ 3,652 |
Schedule of accrued liabilities | Accrued liabilities (in thousands) December 31, 2019 2018 Accrued employee related costs $ 7,682 $ 7,472 Clinical trial accruals 1,680 2,434 Accrued consulting and other professional fees 4,867 4,230 Accrued sales deductions 1,822 1,053 Other 66 341 Accrued liabilities $ 16,117 $ 15,530 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | The Company began capitalizing inventory in August 2017 once the FDA approved GOCOVRI. Inventory consists of the following (in thousands): December 31, 2019 2018 Raw materials $ 1,057 $ 1,330 Work-in-process 1,925 2,174 Finished goods 2,285 1,617 Total inventory $ 5,267 $ 5,121 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of balance sheet classification of operating lease liabilities | Supplemental balance sheet information related to operating leases were as follows (in thousands): December 31, 2019 Assets Operating lease right-of-use assets $ 8,048 Total right-of-use assets $ 8,048 Liabilities Current portion included in other current liabilities $ 1,669 Long-term portion of operating lease liabilities 8,272 Total operating lease liabilities $ 9,941 |
Schedule of components of lease cost | The components of lease costs, which were included in selling, general and administrative, net in its consolidated statements of operations, were as follows (in thousands): Year Ended December 31, 2019 Operating lease cost $ 2,037 Variable lease cost 320 Total lease cost $ 2,357 |
Schedule of the maturities of operating lease liabilities | As of December 31, 2019, the maturities of operating lease liabilities were as follows (in thousands): Operating leases 2020 $ 2,603 2021 2,610 2022 2,431 2023 2,181 2024 2,247 Thereafter 764 Total lease payments 12,836 Less: Imputed interest (2,895) Operating lease liabilities $ 9,941 |
Schedule of future minimum lease payments under the non-cancelable facility operating lease | As of December 31, 2018, future minimum lease payments under the non-cancelable facility operating lease, were as follows (in thousands): Amount 2019 $ 1,938 2020 1,996 2021 2,056 2022 2,118 2023 2,181 Thereafter 3,011 Total $ 13,300 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt and unamortized debt discount balances | Payment obligations under the Royalty-Backed Loan are as follows (in thousands): December 31, 2019 2018 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (63,217) (78,261) Less: Payments made (9,068) (2,618) Carrying value of loans payable $ 127,715 $ 119,121 Less: Current portion of long-term debt (2,041) (1,664) Non-current portion of long-term debt $ 125,674 $ 117,457 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Schedule of shares of Company's common stock reserved for future issuance | Shares of the Company’s common stock reserved for future issuance are as follows: December 31, 2019 2018 Common stock awards issued and outstanding 6,874,633 5,949,436 Authorized for future issuance under 2014 Equity Incentive Plan 2,376,613 1,814,179 Authorized for future issuance under 2016 Inducement Plan 236,269 512,440 Employee stock purchase plan 926,943 847,105 Total 10,414,458 9,123,160 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of activity under the company's stock option plans | Stock option activity under all of the Company’s stock compensation plans is summarized as follows: Outstanding Options Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (thousands) Number of Shares Weighted Average Exercise Price Stock Options Balances, December 31, 2018 5,301,066 $ 14.98 Options granted 1,721,508 6.48 Options exercised (184,626) 1.59 Options forfeited (605,595) 18.69 Options expired (715,669) 17.34 Balances, December 31, 2019 5,516,684 $ 12.06 5.43 $ 2,015 Vested and expected to vest, December 31, 2019 5,334,042 $ 12.09 5.35 $ 2,015 Exercisable, December 31, 2019 3,487,330 $ 12.54 3.97 $ 2,015 |
Schedule of restricted stock unit and related activity | Restricted stock unit activity under all of the Company’s stock compensation plans is summarized as follows: Outstanding Units Weighted-Average Restricted Stock Units Number of Shares Unvested, December 31, 2018 648,370 $ 16.57 Granted 1,185,093 5.61 Vested (151,288) 16.94 Forfeited (324,226) 13.12 Unvested, December 31, 2019 1,357,949 $ 7.79 |
Schedule of allocation of total stock-based compensation expense | The following table reflects stock-based compensation expense recognized for the years ended December 31, 2019, 2018, and 2017 (in thousands): Years Ended December 31, 2019 2018 2017 Research and development $ 1,732 $ 2,822 $ 3,597 Selling, general and administrative 11,120 12,964 9,770 Total stock-based compensation expense $ 12,852 $ 15,786 $ 13,367 |
Schedule of assumptions used to estimate fair value of stock options | The Company estimated the fair value of employee stock options and ESPP shares on the date of grant using the Black-Scholes model with the following weighted-average assumptions: Years Ended December 31, 2019 2018 2017 Stock Options Expected price volatility 65% - 69% 67% - 70% 68% - 70% Risk-free interest rate 1.52% - 2.58% 2.27% - 3.06% 1.83% - 2.17% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 5.50 - 6.25 Dividend yield — — — Years Ended December 31, 2019 2018 2017 Employee Stock Purchase Plan Expected price volatility 53% - 56% 62% - 64% 51% - 71% Risk-free interest rate 1.60% - 2.35% 2.10% - 2.56% 0.60% - 1.45% Expected term (in years) 0.50 0.50 0.50 Dividend yield — — — The Company estimated the fair value of non-employee stock options using the Black-Scholes model with the following weighted-average assumptions: Years Ended December 31, 2019 2018 2017 Expected price volatility — 69% - 74% 68% - 80% Risk-free interest rate — 2.32% - 2.45% 1.94% - 2.36% Expected term (in years) — 6.00 - 9.50 6.00 - 9.75 Dividend yield — — — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Summary of loss before benefit for income tax | Loss before benefit for income tax is summarized as follows (in thousands): Years Ended December 31, 2019 2018 2017 United States $ (105,186) $ (130,999) $ (91,220) International — — — Total $ (105,186) $ (130,999) $ (91,220) |
Summary of income tax benefit | The benefit for income taxes is summarized as follows (in thousands): December 31, 2019 2018 2017 Current: Federal $ — $ — $ (1,730) State — — — Benefit for income taxes $ — $ — $ (1,730) |
Schedule showing the difference of benefit for income taxes from the amount computed by applying the federal income tax rate of 35% to pretax loss from operations | The benefit for income taxes differs from the amount computed by applying the federal income tax rate of 21% to pretax loss from operations as a result of the following: December 31, 2019 2018 2017 Statutory federal income tax rate $ (22,079) $ (27,510) $ (31,927) State income taxes, net of federal tax benefits (8,473) (10,296) (5,041) Tax credits (1,398) (2,587) (2,306) Impact of federal rate change — — 24,907 Change in statutory rates — 34 (1,440) Stock compensation 2,648 (569) (2,558) Nondeductible compensation 278 — — State net operating losses — — 633 Other 198 798 — Change in valuation allowance 28,826 40,130 16,002 Income tax benefit $ — $ — $ (1,730) |
Schedule of deferred tax assets and liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2019 2018 Deferred tax assets Net operating loss carryforwards $ 99,449 $ 75,143 Research and development tax credits 20,174 18,776 Accruals and reserves 7,004 4,655 Stock compensation 9,291 8,662 Depreciation and amortization 1,108 1,437 Lease liabilities 2,889 — Other (rate change) — 77 Gross deferred tax assets 139,915 108,750 Less: Valuation allowance (137,576) (108,750) Net deferred tax assets 2,339 — Deferred tax liabilities Right of use assets (2,339) — Net deferred tax liabilities (2,339) — Net deferred taxes $ — $ — |
Schedule of reconciliation of the beginning and ending amount of unrecognized tax benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): December 31, 2019 2018 2017 Balance at the beginning of the year $ 4,697 $ 4,034 $ 3,188 Additions based on prior period tax positions — 220 43 Additions based on current period tax positions 368 443 803 Balance at the end of the year $ 5,065 $ 4,697 $ 4,034 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of reconciliation of numerator and denominator used in calculation of basic and diluted net loss per share | The following table presents the calculation of the basic and diluted net loss per share (in thousands, except per share data): Years Ended December 31, 2019 2018 2017 Net loss attributable to common stockholders, basic and diluted $ (105,186) $ (130,999) $ (89,490) Weighted average common shares used in calculating net loss per common share, basic and diluted 27,677 26,886 22,558 Net loss per share attributable to common stockholders, basic and diluted $ (3.80) $ (4.87) $ (3.97) |
Schedule of outstanding shares of potentially dilutive securities excluded from the computation of diluted net loss per share of common stock, because including them would have been anti-dilutive | The following total outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented, because including them would have been anti-dilutive (in thousands): December 31, 2019 2018 2017 Options to purchase common stock 5,517 5,301 5,138 Restricted stock units 1,358 648 427 Total 6,875 5,949 5,565 |
Quarterly Financial Informati_2
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of unaudited quarterly information | These operating results are not necessarily indicative of results for any future period (in thousands, except per share data): Year Ended December 31, 2019 First Quarter Second Quarter Third Quarter Fourth Quarter Total revenues $ 11,665 $ 12,691 $ 13,933 $ 16,348 Gross profit(1) 11,252 12,006 13,004 15,906 Net loss (29,658) (24,871) (27,582) (23,075) Net loss per share, basic and diluted (1.08) (0.90) (0.99) (0.83) Year Ended December 31, 2018 First Quarter Second Quarter Third Quarter Fourth Quarter Total revenues $ 2,553 $ 7,565 $ 10,613 $ 13,315 Gross profit(1) 2,528 7,492 10,513 12,880 Net loss (34,971) (33,993) (33,152) (28,883) Net loss per share, basic and diluted (1.35) (1.26) (1.22) (1.06) (1) Gross profit is computed by subtracting cost of product sales from product sales. |
Description of Business (Detail
Description of Business (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Liquidity (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jan. 31, 2018 | May 31, 2017 | Dec. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | ||||||
Proceeds from public offerings, net of offering costs | $ 134,300 | $ 0 | $ 134,268 | $ 0 | ||
Cash, cash equivalents and investments | $ 132,600 | |||||
HCRP | Royalty-backed loan agreement | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of debt | $ 35,000 | $ 65,000 | $ 100,000 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Inventory (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | |||
Write-down of GOCOVRI finished goods | $ 884,000 | $ 232,000 | $ 0 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Segments (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Basis of Presentation and Sum_7
Basis of Presentation and Summary of Significant Accounting Policies - Concentration of Risk (Details) - Customer One - Customer Concentration Risk | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue from Contract with Customer | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 98.00% | 99.00% |
Accounts Receivable | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 96.00% | 99.00% |
Basis of Presentation and Sum_8
Basis of Presentation and Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computer equipment and software | |
Property and Equipment | |
Estimated useful lives of the assets | 3 years |
Equipment | |
Property and Equipment | |
Estimated useful lives of the assets | 5 years |
Furniture and fixtures | |
Property and Equipment | |
Estimated useful lives of the assets | 10 years |
Basis of Presentation and Sum_9
Basis of Presentation and Summary of Significant Accounting Policies - Recently Adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use assets | $ 8,048 | $ 7,566 | |
Other current liabilities | 1,858 | 1,280 | $ 512 |
Long-term portion of operating lease liabilities | 8,272 | 8,643 | |
Other non-current liabilities | $ 2,157 | 1,352 | $ 3,196 |
Restatement Adjustment | Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use assets | 7,566 | ||
Other current liabilities | 768 | ||
Long-term portion of operating lease liabilities | 8,643 | ||
Other non-current liabilities | $ (1,844) |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities (Details) - Recurring basis - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Total assets measured at fair value | $ 99,035 | $ 172,054 |
Liabilities: | ||
Total liabilities measured at fair value | 2,157 | 1,352 |
Level 1 | ||
Assets: | ||
Total assets measured at fair value | 27,720 | 17,789 |
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Level 2 | ||
Assets: | ||
Total assets measured at fair value | 71,315 | 154,265 |
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Liabilities: | ||
Total liabilities measured at fair value | 2,157 | 1,352 |
Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 2,157 | 1,352 |
Embedded derivative liability | Level 1 | ||
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Embedded derivative liability | Level 2 | ||
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Embedded derivative liability | Level 3 | ||
Liabilities: | ||
Total liabilities measured at fair value | 2,157 | 1,352 |
Money market | ||
Assets: | ||
Total assets measured at fair value | 27,720 | 17,789 |
Money market | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 27,720 | 17,789 |
Money market | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Money market | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Corporate debt | ||
Assets: | ||
Total assets measured at fair value | 22,576 | 19,792 |
Corporate debt | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Corporate debt | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 22,576 | 19,792 |
Corporate debt | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury notes | ||
Assets: | ||
Total assets measured at fair value | 37,811 | 131,512 |
U.S. Treasury notes | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury notes | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 37,811 | 131,512 |
U.S. Treasury notes | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Commercial paper | ||
Assets: | ||
Total assets measured at fair value | 10,928 | 2,961 |
Commercial paper | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Commercial paper | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 10,928 | 2,961 |
Commercial paper | Level 3 | ||
Assets: | ||
Total assets measured at fair value | $ 0 | $ 0 |
Fair Value Measurements - Rollf
Fair Value Measurements - Rollforward of Level 3 financial instruments (Details) - Level 3 - Long-term debt with embedded derivative - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Roll forward of the financial instruments classified within Level 3 of the fair value hierarchy | |||
Beginning balance | $ 1,352 | $ 470 | $ 0 |
Issuance of long-term debt with embedded derivative | 764 | ||
Change in fair value included in interest and other income, net | 805 | 882 | (294) |
Ending balance | $ 2,157 | $ 1,352 | $ 470 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 66,817 | $ 154,529 |
Gross Unrealized Gains | 25 | 10 |
Gross Unrealized Losses | (9) | (274) |
Fair Value | 66,833 | 154,265 |
Short-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 66,817 | 154,529 |
Gross Unrealized Gains | 25 | 10 |
Gross Unrealized Losses | (9) | (274) |
Fair Value | 66,833 | 154,265 |
Accrued interest | 400 | 500 |
Long-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 0 | $ 0 |
Long-term investments | Minimum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity date of long term investment | 12 months | 12 months |
Corporate debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 22,582 | $ 19,833 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | (9) | (41) |
Fair Value | 22,576 | 19,792 |
U.S. Treasury notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 37,789 | 131,735 |
Gross Unrealized Gains | 22 | 10 |
Gross Unrealized Losses | 0 | (233) |
Fair Value | 37,811 | 131,512 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 6,446 | 2,961 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 6,446 | $ 2,961 |
Balance Sheet Components (Detai
Balance Sheet Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Prepaid expenses and other current assets | |||
Prepaid expenses | $ 2,624 | $ 2,969 | |
Prepaid clinical trial | 2,710 | 2,299 | |
Income tax receivable | 1,259 | 840 | |
Other current assets | 83 | 763 | |
Prepaid expenses and other current assets | 6,676 | 6,871 | |
Property and equipment, gross | 5,908 | 5,897 | |
Less: Accumulated depreciation and amortization | (3,459) | (2,245) | |
Property and equipment, net | 2,449 | 3,652 | |
Depreciation expense | 1,214 | 1,460 | $ 1,194 |
Accrued liabilities | |||
Accrued employee related costs | 7,682 | 7,472 | |
Clinical trial accruals | 1,680 | 2,434 | |
Accrued consulting and other professional fees | 4,867 | 4,230 | |
Accrued sales deductions | 1,822 | 1,053 | |
Other | 66 | 341 | |
Accrued liabilities | 16,117 | 15,530 | |
Computer equipment and software | |||
Prepaid expenses and other current assets | |||
Property and equipment, gross | 3,297 | 3,286 | |
Equipment | |||
Prepaid expenses and other current assets | |||
Property and equipment, gross | 384 | 384 | |
Furniture and fixtures | |||
Prepaid expenses and other current assets | |||
Property and equipment, gross | 336 | 336 | |
Leasehold improvements | |||
Prepaid expenses and other current assets | |||
Property and equipment, gross | $ 1,891 | $ 1,891 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,057 | $ 1,330 |
Work-in-process | 1,925 | 2,174 |
Finished goods | 2,285 | 1,617 |
Total inventory | $ 5,267 | $ 5,121 |
License Agreements (Details)
License Agreements (Details) | Nov. 30, 2012USD ($) | Dec. 31, 2019USD ($)claim | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Collaboration and License Agreements | ||||
Number of legal claims | claim | 0 | |||
Non-cancelable purchase commitments due within one year | $ 4,000,000 | |||
License agreement | ||||
Collaboration and License Agreements | ||||
Upfront payment received | $ 65,000,000 | |||
Maximum total additional cash payments receivable upon achievement of certain development and regulatory milestones | $ 95,000,000 | |||
Prosecution and litigation cost | $ 0 | $ 1,000 | $ 33,000 | |
Period describing the commercial launch of dose | 15 years |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2019vehicle | Jun. 30, 2018USD ($) | Jan. 31, 2018USD ($)ft²option | Dec. 31, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Lessee, Lease, Description [Line Items] | |||||||
Operating lease, cash payments to be required | $ 1,188 | $ 0 | $ 0 | ||||
Lease, cost | $ 2,357 | $ 2,400 | |||||
Rent expense | $ 1,200 | $ 700 | |||||
Weighted average remaining lease term | 4 years 10 months 24 days | 4 years 10 months 24 days | |||||
Weighted average discount rate | 10.30% | 10.30% | |||||
Office equipment | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Operating lease, term | 3 years | ||||||
Operating lease, cash payments to be required | $ 200 | ||||||
Vehicles | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Operating lease, term | 3 years | ||||||
Operating lease, number of vehicles | vehicle | 65 | ||||||
Operating lease, term of contract per vehicle | 12 months | ||||||
Operating lease, renewal term | 50 months | ||||||
Emeryville, CA | Office facility | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Lessee, operating lease, rentable square feet (in sqft) | ft² | 37,626 | ||||||
Operating lease, number of options to extend | option | 1 | ||||||
Operating lease, option to extend, term | 5 years | ||||||
Operating lease, tenet improvement allowance | $ 1,100 |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
Operating lease right-of-use assets | $ 8,048 | $ 7,566 |
Current portion included in other current liabilities | 1,669 | |
Long-term portion of operating lease liabilities | 8,272 | $ 8,643 |
Total operating lease liabilities | $ 9,941 |
Leases - Components of Lease Co
Leases - Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Dec. 31, 2019 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Operating lease cost | $ 2,037 | |
Variable lease cost | 320 | |
Total lease cost | $ 2,357 | $ 2,400 |
Leases - Maturities of Operatin
Leases - Maturities of Operating Lease Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 2,603 |
2021 | 2,610 |
2022 | 2,431 |
2023 | 2,181 |
2024 | 2,247 |
Thereafter | 764 |
Total lease payments | 12,836 |
Less: Imputed interest | (2,895) |
Operating lease liabilities | $ 9,941 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 1,938 |
2020 | 1,996 |
2021 | 2,056 |
2022 | 2,118 |
2023 | 2,181 |
Thereafter | 3,011 |
Total | $ 13,300 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Dec. 31, 2019USD ($)claim |
Loss Contingencies [Line Items] | |
Non-cancelable purchase commitments due within one year | $ 4 |
Number of legal claims | claim | 0 |
Qui Tam Complaint | Pending Litigation | Unfavorable Regulatory Action | |
Loss Contingencies [Line Items] | |
Estimate of possible loss (potentially more than) | $ 2,500 |
Long-term Debt (Details)
Long-term Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 7 Months Ended | 12 Months Ended | ||
May 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | ||||||
Payment of debt issuance costs | $ 0 | $ 0 | $ 633,000 | |||
HCRP | Royalty-backed loan agreement | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of debt | $ 35,000,000 | $ 65,000,000 | 100,000,000 | |||
Percentage revenue interest of future net sales | 12.50% | |||||
Quarterly royalty payment (up to) | $ 15,000,000 | |||||
Royalty percentage of future net sales | 6.25% | |||||
Royalty trail cap, percentage of face amount | 200.00% | |||||
Voluntary prepay election, amount due, percentage of funded amount | 200.00% | |||||
Interest rate, stated percentage | 11.00% | |||||
Contingent consideration, asset | $ 65,000,000 | |||||
Unpaid interest payment added to principal amount, term | 2 years 3 months | |||||
Lender expense | $ 400,000 | 400,000 | ||||
Payment of debt issuance costs | $ 800,000 | |||||
Interest expense | $ 15,000,000 | $ 19,100,000 | $ 4,600,000 | |||
Effective interest rate | 13.40% | |||||
HCRP | Royalty-backed loan agreement | Level 3 | ||||||
Debt Instrument [Line Items] | ||||||
Long-term debt, fair value | $ 108,100,000 | |||||
HCRP | Royalty-backed loan agreement | December 2021 | ||||||
Debt Instrument [Line Items] | ||||||
Royalty percentage of future net sales if principal and interest payments below minimum specified levels (up to) | 17.50% | |||||
HCRP | Royalty-backed loan agreement | December 2022 | ||||||
Debt Instrument [Line Items] | ||||||
Royalty percentage of future net sales if principal and interest payments below minimum specified levels (up to) | 22.50% |
Long-term Debt - Long-Term Debt
Long-term Debt - Long-Term Debt and Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Less: Current portion of long-term debt | $ (2,041) | $ (1,664) |
Non-current portion of long-term debt | 125,674 | 117,457 |
HCRP | Royalty-backed loan agreement | ||
Debt Instrument [Line Items] | ||
Total repayment obligation | 200,000 | 200,000 |
Less: Interest to be accreted in future periods | (63,217) | (78,261) |
Less: Payments made | (9,068) | (2,618) |
Carrying value of loans payable | 127,715 | 119,121 |
Less: Current portion of long-term debt | (2,041) | (1,664) |
Non-current portion of long-term debt | $ 125,674 | $ 117,457 |
Convertible Preferred Stock (De
Convertible Preferred Stock (Details) - shares | Dec. 31, 2019 | Dec. 31, 2018 | Apr. 15, 2014 |
Temporary Equity Disclosure [Abstract] | |||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2019USD ($)vote$ / sharesshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($) | Nov. 30, 2019USD ($) | Mar. 31, 2016shares | |
Shareholders' Equity | ||||||
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | ||||
Dividends declared | $ | $ 0 | |||||
Number of votes per share | vote | 1 | |||||
Share price (in dollars per share) | $ / shares | $ 3.79 | |||||
Proceeds from follow-on offering | $ | $ 134,300,000 | $ 0 | $ 134,268,000 | $ 0 | ||
Number of shares available for future issuance under the plan (in shares) | 10,414,458 | 9,123,160 | ||||
2016 Inducement Plan | ||||||
Shareholders' Equity | ||||||
Number of shares available for future issuance under the plan (in shares) | 236,269 | 450,000 | ||||
Employee Stock Purchase Plan | ||||||
Shareholders' Equity | ||||||
Number of shares available for future issuance under the plan (in shares) | 926,943 | 847,105 | ||||
Cowen and Company, LLC | ||||||
Shareholders' Equity | ||||||
At-the-market offering, aggregate offering price (up to) | $ | $ 50,000,000 | |||||
At-the-market offering, commission as a percentage of gross proceeds (up to) | 3.00% | |||||
Stock options | ||||||
Shareholders' Equity | ||||||
Number of shares available for future issuance under the plan (in shares) | 6,874,633 | 5,949,436 | ||||
Stock options | 2014 Equity Incentive Plan | ||||||
Shareholders' Equity | ||||||
Authorized for future issuance (in shares) | 2,376,613 | 1,814,179 | ||||
Stock options | 2016 Inducement Plan | ||||||
Shareholders' Equity | ||||||
Authorized for future issuance (in shares) | 236,269 | 512,440 | ||||
Common Stock | ||||||
Shareholders' Equity | ||||||
Common stock shares sold (in shares) | 3,450,000 | 3,450,000 | ||||
Share price (in dollars per share) | $ / shares | $ 41.50 | |||||
Proceeds from follow-on offering | $ | $ 134,300,000 | |||||
Common Stock | Stock options | Over-Allotment Option | ||||||
Shareholders' Equity | ||||||
Common stock shares sold (in shares) | 450,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Compensation Plans (Details) - shares | Jan. 01, 2019 | Mar. 31, 2019 | Nov. 30, 2017 | Jan. 31, 2017 | Mar. 31, 2016 | Mar. 31, 2014 | Mar. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares available for future issuance under the plan (in shares) | 10,414,458 | 9,123,160 | |||||||||
Stock options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares available for future issuance under the plan (in shares) | 6,874,633 | 5,949,436 | |||||||||
2002 Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares of common stock available for future grant or issuance (in shares) | 0 | ||||||||||
2007 Stock Plan | Stock options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares of common stock available for future grant or issuance (in shares) | 0 | ||||||||||
2014 Equity Incentive Plan | Stock options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares of common stock available for future grant or issuance (in shares) | 1,993,394 | 2,376,613 | |||||||||
Increase in common stock reserved for issuance as a percentage of total number of shares of the Company's capital stock outstanding on the last day of the preceding fiscal year | 4.00% | ||||||||||
Increase in common stock available for issuance (in shares) | 1,097,374 | ||||||||||
Threshold ownership percentage of shareholder for determining exercise price of awards granted | 10.00% | ||||||||||
Vesting period | 4 years | ||||||||||
2014 Equity Incentive Plan | Stock options | Maximum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Term of awards | 10 years | ||||||||||
2014 Equity Incentive Plan | Stock options | Minimum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Exercise price as a percentage of estimated fair value of the shares on the date of grant | 100.00% | ||||||||||
Exercise price as a percentage of estimated grant date fair value of shares for a 10% shareholder | 110.00% | ||||||||||
2016 Inducement Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares available for future issuance under the plan (in shares) | 450,000 | 236,269 | |||||||||
Number of additional shares available for future issuance under the plan (in shares) | 450,000 | 450,000 | 450,000 | 1,350,000 | 1,800,000 | ||||||
2016 Inducement Plan | Employee Stock Options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Term of awards | 10 years | ||||||||||
Vesting period | 4 years | ||||||||||
2016 Inducement Plan | Employee Stock Options | Maximum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Term of awards | 10 years |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Aggregate Intrinsic Value (thousands) | |||
Fair value of common stock (in dollars per share) | $ 3.79 | ||
Stock options | |||
Number of Shares | |||
Balances, beginning of the period (in shares) | 5,301,066 | ||
Options granted (in shares) | 1,721,508 | ||
Options exercised (in shares) | (184,626) | ||
Options forfeited (in shares) | (605,595) | ||
Options expired (in shares) | (715,669) | ||
Balances, end of the period (in shares) | 5,516,684 | 5,301,066 | |
Vested and expected to vest, end of the period (in shares) | 5,334,042 | ||
Vested, end of the period (in shares) | 3,487,330 | ||
Weighted Average Exercise Price | |||
Balances, beginning of the period (in dollars per share) | $ 14.98 | ||
Options granted (in dollars per share) | 6.48 | ||
Options exercised (in dollars per share) | 1.59 | ||
Options forfeited (in dollars per share) | 18.69 | ||
Options expired (in dollars per share) | 17.34 | ||
Balances, end of the period (in dollars per share) | 12.06 | $ 14.98 | |
Vested and expected to vest, end of the period (in shares) | 12.09 | ||
Vested, end of the period (in shares) | $ 12.54 | ||
Weighted- Average Remaining Contractual Term (years) | |||
Balances, end of the period | 5 years 5 months 4 days | ||
Vested and expected to vest, end of the period | 5 years 4 months 6 days | ||
Vested, end of the period | 3 years 11 months 19 days | ||
Aggregate Intrinsic Value (thousands) | |||
Balances, end of the period | $ 2,015 | ||
Vested and expected to vest, end of the period | 2,015 | ||
Vested, end of the period | 2,015 | ||
Aggregate intrinsic value of exercises | $ 900 | $ 9,200 | $ 18,100 |
Employee Stock Options | |||
Number of Shares | |||
Options granted (in shares) | 1,721,508 | 1,289,396 | 1,439,675 |
Aggregate Intrinsic Value (thousands) | |||
Weighted-average grant date fair value (in dollars per share) | $ 4.01 | $ 16.08 | $ 11.93 |
Compensation not yet recognized | $ 10,500 | ||
Period for recognition of unrecognized compensation cost | 2 years 7 months 6 days | ||
Total fair value of awards vested | $ 9,600 | $ 12,100 | $ 10,600 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Activity (Details) - Restricted Stock Units (RSUs) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares | |||
Unvested, Beginning balance (in shares) | 648,370 | ||
Granted (in shares) | 1,185,093 | ||
Vested (in shares) | (151,288) | ||
Forfeited (in shares) | (324,226) | ||
Unvested, Ending balance (in shares) | 1,357,949 | 648,370 | |
Weighted-Average Grant Date Fair Value | |||
Unvested, Beginning balance (in dollars per share) | $ 16.57 | ||
Granted (in dollars per share) | 5.61 | ||
Vested (in dollars per share) | 16.94 | ||
Forfeited (in dollars per share) | 13.12 | ||
Unvested, Ending balance (in dollars per share) | $ 7.79 | $ 16.57 | |
Aggregate intrinsic value, outstanding | $ 5,100,000 | ||
Aggregate intrinsic value, vested | 1,000,000 | $ 2,300,000 | $ 1,200,000 |
Unrecognized compensation cost | $ 7,700,000 | ||
Period for recognition of unrecognized compensation cost | 2 years 4 months 24 days |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plan (Details) - USD ($) | Jan. 01, 2019 | Mar. 31, 2014 | Dec. 31, 2019 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares available for future issuance under the plan (in shares) | 10,414,458 | 9,123,160 | ||
Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Authorized for future issuance (in shares) | 262,762 | |||
Exercise price as a percentage of estimated fair value of the shares on the date of grant | 85.00% | |||
Value of shares that an employee is permitted to purchase | $ 25,000 | |||
Stock issued under employee stock purchase plan (in shares) | 423,826 | |||
Number of shares available for future issuance under the plan (in shares) | 926,943 | |||
Increase in common stock available for issuance (in shares) | 274,344 | |||
Employee Stock Purchase Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Percentage of annual compensation of the employee to be deducted for purchase of shares | 15.00% | |||
Increase in common stock reserved for issuance as a percentage of total number of shares of the Company's capital stock outstanding on the last day of the preceding fiscal year | 1.00% | |||
Threshold number of shares to determine increase in common stock reserved for future issuance (in shares) | 520,000 |
Stock-Based Compensation - St_3
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 12,852 | $ 15,786 | $ 13,367 |
Stock-based compensation capitalized in inventory | 208 | 202 | 39 |
Employee Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 9,400 | 12,700 | 11,200 |
Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 400 | 600 | 300 |
Restricted Stock Units (RSUs) | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 3,100 | 2,300 | 1,300 |
Employee Stock Options and Restricted Stock Units (RSUs) | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Plan modification, incremental compensation cost | 2,200 | ||
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 1,732 | 2,822 | 3,597 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 11,120 | $ 12,964 | $ 9,770 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted Average Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Stock Options | |||
Assumptions to estimate the fair value of stock options | |||
Expected price volatility, minimum | 65.00% | 67.00% | 68.00% |
Expected price volatility, maximum | 69.00% | 70.00% | 70.00% |
Risk-free interest rate, minimum | 1.52% | 2.27% | 1.83% |
Risk-free interest rate, maximum | 2.58% | 3.06% | 2.17% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Employee Stock Options | Minimum | |||
Assumptions to estimate the fair value of stock options | |||
Expected term | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Employee Stock Options | Maximum | |||
Assumptions to estimate the fair value of stock options | |||
Expected term | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Employee Stock Purchase Plan | |||
Assumptions to estimate the fair value of stock options | |||
Expected price volatility, minimum | 53.00% | 62.00% | 51.00% |
Expected price volatility, maximum | 56.00% | 64.00% | 71.00% |
Risk-free interest rate, minimum | 1.60% | 2.10% | 0.60% |
Risk-free interest rate, maximum | 2.35% | 2.56% | 1.45% |
Expected term | 6 months | 6 months | 6 months |
Dividend yield | 0.00% | 0.00% | 0.00% |
Non-employee Stock Options | |||
Assumptions to estimate the fair value of stock options | |||
Expected price volatility, minimum | 69.00% | 68.00% | |
Expected price volatility, maximum | 74.00% | 80.00% | |
Risk-free interest rate, minimum | 2.32% | 1.94% | |
Risk-free interest rate, maximum | 2.45% | 2.36% | |
Dividend yield | 0.00% | 0.00% | 0.00% |
Non-employee Stock Options | Minimum | |||
Assumptions to estimate the fair value of stock options | |||
Expected term | 6 years | 6 years | |
Non-employee Stock Options | Maximum | |||
Assumptions to estimate the fair value of stock options | |||
Expected term | 9 years 6 months | 9 years 9 months |
Stock-Based Compensation - Non-
Stock-Based Compensation - Non-Employee Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 12,852 | $ 15,786 | $ 13,367 |
Non-employee Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted (in shares) | 0 | 0 | 5,000 |
Stock-based compensation expense | $ 0 | $ 200 | $ 600 |
Non-employee Restricted Stock Units (RSUs) | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Granted (in shares) | 0 | 0 | 12,437 |
Income Taxes - Benefit for Inco
Income Taxes - Benefit for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income (loss) before provision for income tax | |||
United States | $ (105,186) | $ (130,999) | $ (91,220) |
International | 0 | 0 | 0 |
Loss before income taxes | (105,186) | (130,999) | (91,220) |
Current: | |||
Federal | 0 | 0 | (1,730) |
State | 0 | 0 | 0 |
Benefit for income taxes | 0 | 0 | (1,730) |
Difference of provision for income taxes from the amount computed by applying the federal income tax rate of 35% to pretax income from operations | |||
Statutory federal income tax rate | (22,079) | (27,510) | (31,927) |
State income taxes, net of federal tax benefits | (8,473) | (10,296) | (5,041) |
Tax credits | (1,398) | (2,587) | (2,306) |
Impact of federal rate change | 0 | 0 | 24,907 |
Change in statutory rates | 0 | 34 | (1,440) |
Stock compensation | 2,648 | (569) | (2,558) |
Nondeductible compensation | 278 | 0 | 0 |
State net operating losses | 0 | 0 | 633 |
Lease liabilities | 2,889 | ||
Other | 198 | 798 | 0 |
Change in valuation allowance | 28,826 | 40,130 | 16,002 |
Benefit for income taxes | 0 | 0 | $ (1,730) |
Significant components of the Company's deferred tax assets | |||
Net operating loss carryforwards | 99,449 | 75,143 | |
Research and development tax credits | 20,174 | 18,776 | |
Accruals and reserves | 7,004 | 4,655 | |
Stock compensation | 9,291 | 8,662 | |
Depreciation and amortization | 1,108 | 1,437 | |
Other (rate change) | 0 | 77 | |
Gross deferred tax assets | 139,915 | 108,750 | |
Less: Valuation allowance | (137,576) | (108,750) | |
Net deferred tax assets | 2,339 | 0 | |
Significant components of deferred tax liabilities | |||
Right of use assets | (2,339) | ||
Net deferred tax liabilities | (2,339) | 0 | |
Net deferred taxes | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating loss carryforwards | ||
Federal income tax rate | 21.00% | |
Increase in net valuation allowance | $ 28.8 | $ 40.1 |
Deferred tax assets, tax credit carryforwards, alternative minimum tax | 1.7 | |
Research and development tax credit carryforward | ||
Operating loss carryforwards | ||
Tax credit carryforwards | 14.4 | |
Federal | ||
Operating loss carryforwards | ||
Net operating loss carryforwards | 354.4 | 271.6 |
Federal | Research and development tax credit carryforward | ||
Operating loss carryforwards | ||
Tax credit carryforwards | 6.6 | |
State | ||
Operating loss carryforwards | ||
Net operating loss carryforwards | 325.8 | $ 236.2 |
State | Research and development tax credit carryforward | ||
Operating loss carryforwards | ||
Tax credit carryforwards | $ 4.3 |
Income Taxes - Uncertain Tax Po
Income Taxes - Uncertain Tax Positions (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized tax benefits that would impact effective tax rate | $ 0 | ||
Reconciliation of the beginning and ending amount of unrecognized tax benefits | |||
Balance at the beginning of the year | 4,697,000 | $ 4,034,000 | $ 3,188,000 |
Additions based on prior period tax positions | 0 | 220,000 | 43,000 |
Additions based on current period tax positions | 368,000 | 443,000 | 803,000 |
Balance at the end of the year | 5,065,000 | 4,697,000 | 4,034,000 |
Interest related to unrecognized tax benefits | 0 | $ 0 | 0 |
Tax Cuts and Jobs Act of 2017, incomplete accounting, change in tax rate, deferred tax liability, provisional income tax benefit | $ 24,900,000 | ||
Tax Cuts and Jobs Act of 2017, incomplete accounting, transition tax for AMT credits, provisional income tax benefit | $ 1,700,000 |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss | $ (23,075) | $ (27,582) | $ (24,871) | $ (29,658) | $ (28,883) | $ (33,152) | $ (33,993) | $ (34,971) | $ (105,186) | $ (130,999) | $ (89,490) |
Weighted average common shares used in calculating net loss per share, basic and diluted (in shares) | 27,677 | 26,886 | 22,558 | ||||||||
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.83) | $ (0.99) | $ (0.90) | $ (1.08) | $ (1.06) | $ (1.22) | $ (1.26) | $ (1.35) | $ (3.80) | $ (4.87) | $ (3.97) |
Anti-dilutive securities | |||||||||||
Anti-dilutive securities (in shares) | 6,875 | 5,949 | 5,565 | ||||||||
Options to purchase common stock | |||||||||||
Anti-dilutive securities | |||||||||||
Anti-dilutive securities (in shares) | 5,517 | 5,301 | 5,138 | ||||||||
Restricted stock units | |||||||||||
Anti-dilutive securities | |||||||||||
Anti-dilutive securities (in shares) | 1,358 | 648 | 427 |
Quarterly Financial Informati_3
Quarterly Financial Information (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenues | $ 16,348 | $ 13,933 | $ 12,691 | $ 11,665 | $ 13,315 | $ 10,613 | $ 7,565 | $ 2,553 | $ 54,637 | $ 34,046 | $ 571 |
Gross profit | 15,906 | 13,004 | 12,006 | 11,252 | 12,880 | 10,513 | 7,492 | 2,528 | |||
Net loss | $ (23,075) | $ (27,582) | $ (24,871) | $ (29,658) | $ (28,883) | $ (33,152) | $ (33,993) | $ (34,971) | $ (105,186) | $ (130,999) | $ (89,490) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.83) | $ (0.99) | $ (0.90) | $ (1.08) | $ (1.06) | $ (1.22) | $ (1.26) | $ (1.35) | $ (3.80) | $ (4.87) | $ (3.97) |