Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 30, 2018 | |
Document and Entity Information | ||
Entity Registrant Name | Adamas Pharmaceuticals Inc | |
Entity Central Index Key | 1,328,143 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding (in shares) | 26,982,322 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 50,942 | $ 91,316 |
Available-for-sale securities | 147,588 | 82,126 |
Accounts receivable, net | 1,613 | 367 |
Inventory | 2,455 | 1,704 |
Prepaid expenses and other current assets | 3,492 | 3,662 |
Total current assets | 206,090 | 179,175 |
Property and equipment, net | 3,296 | 3,132 |
Available-for-sale securities, non-current | 88,125 | 2,991 |
Other assets | 877 | 878 |
Total assets | 298,388 | 186,176 |
Current liabilities | ||
Accounts payable | 8,132 | 3,878 |
Accrued liabilities | 12,353 | 12,385 |
Other current liabilities | 435 | 344 |
Total current liabilities | 20,920 | 16,607 |
Long-term debt | 107,105 | 102,647 |
Other non-current liabilities | 760 | 796 |
Total liabilities | 128,785 | 120,050 |
Commitments and Contingencies (Note 7) | ||
Stockholders’ equity | ||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at March 31, 2018 and December 31, 2017 | 0 | 0 |
Common stock, $0.001 par value — 100,000,000 shares authorized, 26,958,014 and 23,320,551 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 32 | 28 |
Additional paid-in capital | 416,604 | 277,964 |
Accumulated other comprehensive loss | (363) | (167) |
Accumulated deficit | (246,670) | (211,699) |
Total stockholders’ equity | 169,603 | 66,126 |
Total liabilities and stockholders’ equity | $ 298,388 | $ 186,176 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Mar. 31, 2018 | Dec. 31, 2017 |
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 shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, issued (in shares) | 26,958,014 | 23,320,551 |
Common stock, outstanding (in shares) | 26,958,014 | 23,320,551 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues: | ||
Product sales | $ 2,553 | $ 0 |
Costs and operating expenses: | ||
Cost of product sales | 25 | 0 |
Research and development | 7,188 | 7,088 |
Selling, general and administrative, net | 26,363 | 9,144 |
Total costs and operating expenses | 33,576 | 16,232 |
Loss from operations | (31,023) | (16,232) |
Interest and other income, net | 878 | 204 |
Interest expense | (4,826) | 0 |
Net loss | $ (34,971) | $ (16,028) |
Net loss per share, basic and diluted (in dollars per share) | $ (1.35) | $ (0.72) |
Weighted average shares used in computing net loss per share, basic and diluted (in shares) | 25,861 | 22,206 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (34,971) | $ (16,028) |
Unrealized gain (loss) on available-for-sale securities | (196) | 27 |
Comprehensive loss | $ (35,167) | $ (16,001) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (34,971,000) | $ (16,028,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation | 383,000 | 284,000 |
Stock-based compensation | 3,741,000 | 2,884,000 |
Accretion of interest expense | 4,826,000 | 0 |
Change in fair value of embedded derivative liability | 24,000 | 0 |
Net accretion of discounts and amortization of premiums of available-for-sale securities | (53,000) | 223,000 |
Changes in assets and liabilities | ||
Accrued interest of available-for-sale securities | (643,000) | (36,000) |
Inventory | (558,000) | 0 |
Prepaid expenses and other assets | 171,000 | 1,043,000 |
Accounts receivable, net | (1,246,000) | (895,000) |
Accounts payable | 3,944,000 | (473,000) |
Accrued liabilities and other liabilities | (417,000) | (938,000) |
Net cash used in operating activities | (24,799,000) | (13,936,000) |
Cash flows from investing activities | ||
Purchases of property and equipment | (502,000) | (364,000) |
Purchases of available-for-sale securities | (178,896,000) | (6,992,000) |
Maturities of available-for-sale securities | 28,800,000 | 17,800,000 |
Net cash provided by (used in) investing activities | (150,598,000) | 10,444,000 |
Cash flows from financing activities | ||
Proceeds from public offerings, net of offering costs | 134,433,000 | 0 |
Proceeds from issuance of common stock upon exercise of stock options | 590,000 | 675,000 |
Net cash provided by financing activities | 135,023,000 | 675,000 |
Net decrease in cash and cash equivalents | (40,374,000) | (2,817,000) |
Cash and cash equivalents at beginning of period | 91,316,000 | 23,735,000 |
Cash and cash equivalents at end of period | 50,942,000 | 20,918,000 |
Supplemental disclosure of noncash investing and financing activities | ||
Purchases of inventory in accounts payable and accrued expenses | 163,000 | 0 |
Purchases of property and equipment in accounts payable and accrued expense | 106,000 | 51,000 |
Stock-based compensation capitalized in inventory | 49,000 | 0 |
Public offering costs in accounts payable and accrued expense | $ 169,000 | $ 0 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS Adamas Pharmaceuticals, Inc. (the “Company”) focuses on time-dependent biology to redefine the treatment experience for patients suffering from chronic neurological diseases. In August 2017, the U.S. Food and Drug Administration (FDA) approved GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company is also advancing its pipeline of differentiated investigational programs, which includes: ADS-5102 in development for the treatment of multiple sclerosis walking impairment; and ADS-4101, a high-dose, modified-release lacosamide in development for the treatment of partial onset seizures in patients with epilepsy. The Company’s goal is to create and commercialize a new generation of medicines intended to lessen the burden of disease on patients, caregivers and society. 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 | 3 Months Ended |
Mar. 31, 2018 | |
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 unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these financial statements do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) considered necessary for the fair presentation of the periods presented. The condensed consolidated balance sheet at December 31, 2017 was derived from the audited consolidated financial statements, but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2018 , or any other future period. Readers should read these interim unaudited condensed consolidated financial statements in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2017 , included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or SEC. The Company’s critical accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2017. 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. Other than the adoption of the new accounting guidance, the Company’s critical accounting policies have not changed materially from December 31, 2017. 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, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, 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. 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 (SP) during October 2017. The Company’s 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 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 SP 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, and TRICARE Retail Pharmacy Refunds Program (TRICARE). 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 SP. The Company uses the expected-value method for estimating rebates and estimates are adjusted quarterly to reflect actual experience. 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 further during the three months ended March 31, 2018. 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. Recent Accounting Pronouncements Accounting Pronouncements Adopted in 2018 In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers with amendments in 2015, 2016, and 2017. The amendment in this ASU provides guidance on the revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The core principle of this update provides guidance to identify the performance obligations under the contract(s) with a customer and how to allocate the transaction price to the performance obligations in the contract. It further provides guidance to recognize revenue when (or as) the entity satisfies a performance obligation. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. This standard replaces most existing revenue recognition guidance. The Company adopted the new standard effective January 1, 2018, using the full retrospective transition method. The Company has evaluated the effect the new guidance will have on its consolidated financial statements and determined the adoption of this guidance to have no material impact on amounts previously reported in its consolidated financial statements. ASU 2014-09 also codified the guidance on other assets and deferred costs relating to contracts with customers with the addition of ASC 340-40. This guidance relates to the accounting for costs of an entity to obtain and fulfill a contract to provide goods or services to the customer. Under the new guidance, an entity shall recognize as an asset the incremental costs of obtaining a contract with a customer if the entity expects to recover those costs. In the Company’s review of the various costs to obtain contracts with customers, it has determined that currently no significant costs are incurred that meet the capitalization criteria. The Company’s costs to fulfill contracts are outside the scope of ASC 340-40 and are typically expensed as incurred. In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718) – Scope of Modification Accounting. The new guidance clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. The Company adopted the new standard effective January 1, 2018, on a prospective basis. The adoption of this guidance did not have an impact on the Company’s consolidated financial statements or disclosures. New Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases . 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. Lessor accounting remains substantially unchanged with the exception that no leases entered into after the effective date will be classified as leveraged leases. For sale leaseback transactions, a sale will only be recognized if the criteria in the new revenue recognition standard are met. For public business entities, this guidance is effective for fiscal periods beginning after December 15, 2018 and interim periods thereafter. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. This guidance is effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2018 | |
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): March 31, 2018 Total Level 1 Level 2 Level 3 Assets: Money market $ 23,175 $ 23,175 $ — $ — Corporate debt 40,371 — 40,371 — U.S. Treasury notes 192,356 — 192,356 — Commercial paper 2,986 — 2,986 — Total assets measured at fair value $ 258,888 $ 23,175 $ 235,713 $ — Liabilities: Embedded derivative liability $ 494 $ — $ — $ 494 Total liabilities measured at fair value $ 494 $ — $ — $ 494 December 31, 2017 Total Level 1 Level 2 Level 3 Assets: Money market $ 68,501 $ 68,501 $ — $ — Corporate debt 23,471 — 23,471 — U.S. Treasury notes 61,646 — 61,646 — Total assets measured at fair value $ 153,618 $ 68,501 $ 85,117 $ — Liabilities: Embedded derivative liability $ 470 $ — $ — $ 470 Total liabilities measured at fair value $ 470 $ — $ — $ 470 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 notes, 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 Royalty-Backed Loan 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 condensed 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 8 “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, 2017 $ 470 Change in fair value included in interest and other income, net 24 Balance as of March 31, 2018 $ 494 There were no transfers between any of the levels of the fair value hierarchy during the three months ended March 31, 2018 . |
Investments
Investments | 3 Months Ended |
Mar. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | INVESTMENTS The Company’s investments consist of corporate debt, U.S. Treasury notes, 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, United States Treasury notes, 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 condensed 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 March 31, 2018 and December 31, 2017 (in thousands): March 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 40,484 $ — $ (113 ) $ 40,371 U.S. Treasury notes 192,606 — (250 ) 192,356 Commercial paper 2,986 — — 2,986 Total $ 236,076 $ — $ (363 ) $ 235,713 Reported as: Short-term investments $ 147,850 $ — $ (262 ) $ 147,588 Long-term investments 88,226 — (101 ) 88,125 Total $ 236,076 $ — $ (363 ) $ 235,713 December 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 23,507 $ — $ (36 ) $ 23,471 U.S. Treasury notes 61,777 — (131 ) 61,646 Total $ 85,284 $ — $ (167 ) $ 85,117 Reported as: Short-term investments $ 82,280 $ — $ (154 ) $ 82,126 Long-term investments 3,004 — (13 ) 2,991 Total $ 85,284 $ — $ (167 ) $ 85,117 Short-term and long-term investments include accrued interest of $0.9 million and $0.3 million , respectively, as of March 31, 2018 . Short-term and long-term investments includes accrued interest of $0.6 million and $14,000 , respectively, as of December 31, 2017 . The Company has not incurred any realized gains or losses on investments for the three months ended March 31, 2018 and 2017 . Investments are classified as short-term or long-term depending on the underlying investment’s maturity date. Long-term investments held by the Company have a maturity date range of greater than 12 months and a maximum of 20 months as of March 31, 2018 . All investments with unrealized losses at March 31, 2018 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. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2018 | |
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): March 31, 2018 December 31, 2017 Raw materials $ 877 $ 859 Work-in-process 1,059 817 Finished goods 519 28 Total inventory $ 2,455 $ 1,704 |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2018 | |
License Agreements | |
License Agreements | LICENSE AGREEMENTS In November 2012, the Company granted 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 three months ended March 31, 2018 and 2017 , there were no reimbursable external costs. In addition, the Company may earn tiered royalty payments based on future net sales of Namzaric and Namenda XR. Beginning in May 2020, the Company will be entitled to receive royalties in the low to mid-teens from Allergan for sales of Namzaric in the United States. Beginning in June 2018, the Company will be entitled to receive royalties in the low to mid-single digits for sales of Namenda XR in the United States. 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. Allergan’s obligation to pay royalties with respect to Namenda XR continues until the expiration of the Orange Book listed patents covering such products. 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. The Company does not expect to receive royalties on net sales of Namenda XR, due to the entry of generic versions of Namenda XR. The Company evaluated the Allergan agreement under Topic 606. Based on that evaluation, the Company has determined that at the date of adoption it has satisfied all performance obligations associated with the upfront and milestone payments for each comparative period presented. Royalties under the license agreement will be recognized when the related sales occur, in accordance with the sales-based royalty exception. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Lease Commitments The Company leases approximately 18,500 square feet of office space in Emeryville, California under an operating lease that expires April 30, 2020. On January 16, 2018, the Company amended its lease agreement to extend its lease until April 30, 2025, and relocate the Company within its current building from the seventh to the tenth and eleventh floors, containing approximately 37,626 rentable square feet. The lease provides for a tenant improvement allowance of approximately $1.1 million . As of March 31, 2018 , none of the allowance was utilized. The initial monthly lease payments are $160,000 , increasing to $197,000 in the final year of the agreement, with a lease abatement for the first three months after the lease commencement. The Company expects to relocate in the third quarter of 2018. 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. 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. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims. 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. As of the date of this filing, several companies have submitted Abbreviated New Drug Applications, or 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 Namenda XR, on which the Company is entitled to receive royalties from Forest beginning in June 2018 in any quarter for which there is not significant competition from generics. In the notices, these companies allege that the patents associated with Namenda XR, some of which are owned by Forest or licensed by Forest from Merz Pharma GmbH & Co. KGaA, and others of which are owned by the Company and licensed by the Company exclusively to Forest in the United States, are invalid, unenforceable, and/or will not be infringed by the companies’ manufacture, use, or sale of generic versions of Namenda XR. The Company, Forest, Merz Pharma GmbH & Co. KGaA, and Merz Pharmaceuticals GmbH (together Merz) filed lawsuits in the U.S. District Court for the District of Delaware for infringement of the relevant patents against all of these companies. As of the date of this filing, the Company and Forest have entered into a series of settlement agreements with all Namenda XR ANDA filers that the Company and Forest chose to file suit against, including with the ANDA filer against whom the Company and Forest filed a lawsuit on June 2, 2017, in the U.S. District Court for the District of Delaware for infringement of certain patents based on that filer’s filing of an ANDA seeking FDA approval to manufacture and market generic versions of Namenda XR that included one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(iv). Entry dates for generic Namenda XR are governed by the settlement agreements in that action. In January 2016, the Delaware District Court issued a claim construction (Markman) ruling in the Namenda XR litigation that includes findings of indefiniteness as to certain claim terms in the asserted patents licensed by the Company to Forest. On July 26, 2016, the District Court issued a final judgment of invalidity on those patents based upon the Markman ruling. The Company and Forest filed the notice of appeal of that final judgment to the United States Court of Appeals for the Federal Circuit (“Federal Circuit”). On December 11, 2017, the Federal Circuit issued a non-precedential opinion affirming the final judgment of the district court. On January 10, 2018, the Company and Forest filed a petition for rehearing/rehearing en banc with the Federal Circuit. On February 12, 2018, the appellate court denied that petition and on February 20, 2018, the mandate of the court was issued. Based upon the terms of certain settlement agreements with generic filers related to Namenda XR, certain generic filers can now commercialize generic versions of Namenda XR, if approved by the FDA. As of March 31, 2018, at least four generic companies have launched generic versions of Namenda XR. Additionally, 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. The Company and Forest have filed lawsuits alleging infringement of the relevant patents against Namzaric ANDA filers, who are seeking to launch generic versions of Namzaric, in the same court as heard the Namenda XR litigation. 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, including with the ANDA filer against whom the Company and Forest filed a lawsuit on June 2, 2017 in the U.S. District Court for the District of Delaware for infringement of certain patents based on that filer’s filing of an ANDA seeking FDA approval to manufacture and market generic versions of Namzaric that included one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(iv). Entry dates for generic Namzaric are governed by the settlement agreements in those actions. 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 April 20, 2017, an opposition was filed against the Company’s European Patent EP 2 506 709 B1, which relates to extended release compositions comprising amantadine or a pharmaceutically acceptable salt thereof. On May 26, 2017, the Company received a Communication of Notices of Opposition (R. 79(1) EPC) from the European Patent Office that requested the Company file its observations in response to the opposition within a period of four months from May 26, 2017. The Company filed its response to the opposition on October 5, 2017. On March 7, 2018, the European Patent Office issued a Preliminary Opinion of the Opposition Division and a Summons to appear at oral proceedings on October 8, 2018. 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 does not infringe certain of the Company’s patents. This action is ongoing and is in a very early stage. 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. 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 | 3 Months Ended |
Mar. 31, 2018 | |
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 $35.0 million , followed by an additional $65.0 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 $15.0 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 $65.0 million additional loan. 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, 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 $4.8 million and zero for the three months ended March 31, 2018 and March 31, 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 March 31, 2018 on the amounts borrowed under the Royalty-Backed Loan, including the amortization of the debt discount, was 19.9% . 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): March 31, 2018 December 31, 2017 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (92,527 ) (97,353 ) Less: Payments made (60 ) — Carrying value of loans payable $ 107,413 $ 102,647 Less: Current portion of long-term debt (308 ) — Non-current portion of long-term debt $ 107,105 $ 102,647 The estimated fair value of the long-term debt, as measured using Level 3 inputs, approximates $111.3 million as of March 31, 2018 . The estimated fair value was calculated in the same methodology as the valuation of the embedded derivative as described further in Note 3. There are no contractual minimum principal payments due until the loan matures in December 2026 as the repayment of the loan amount is contingent upon the sales volumes of GOCOVRI and royalties from Allergan. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2018 | |
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 May 2017, 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 November 21, 2016. 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 March 31, 2018 , 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: March 31, December 31, Common stock awards issued and outstanding 6,265,045 5,564,635 Authorized for future issuance under 2014 Equity Incentive Plan 1,788,884 1,723,733 Authorized for future issuance under 2016 Inducement Plan 618,513 188,715 Employee stock purchase plan 927,062 693,856 Total 9,599,504 8,170,939 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Stock Compensation Plans In January 2018 , the common stock available for issuance under the 2014 Equity Incentive Plan (the “2014 Plan”) automatically increased by 4% of the total number of shares of the Company’s capital stock outstanding on December 31, 2017 , or 932,822 shares. 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 and November 2017, 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 900,000 , resulting in a total of 1,350,000 shares of common stock issuable under the Inducement Plan. Employee Stock Purchase Plan In January 2018 , the common stock available for issuance under the 2014 Employee Stock Purchase Plan (the “ESPP”) automatically increased by 1% of the total number of shares of the Company’s capital stock outstanding on December 31, 2017 , or 233,206 shares. Stock-Based Compensation Expense The following table reflects stock-based compensation expense recognized for the three months ended March 31, 2018 and 2017 (in thousands): Three Months Ended 2018 2017 Research and development $ 772 $ 821 Selling, general and administrative 2,969 2,063 Total stock-based compensation expense $ 3,741 $ 2,884 Stock-based compensation of $49,000 and zero was capitalized into inventory for the three months ended March 31, 2018 and March 31, 2017 , respectively. Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 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 options 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. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. For the three months ended March 31, 2018 and March 31, 2017 , approximately 5,734,000 and 5,688,000 , respectively, shares of potentially dilutive securities were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive. |
Basis of Presentation and Sum18
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these financial statements do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) considered necessary for the fair presentation of the periods presented. The condensed consolidated balance sheet at December 31, 2017 was derived from the audited consolidated financial statements, but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2018 , or any other future period. Readers should read these interim unaudited condensed consolidated financial statements in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2017 , included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or SEC. The Company’s critical accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2017. 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. Other than the adoption of the new accounting guidance, the Company’s critical accounting policies have not changed materially from December 31, 2017. |
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, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, 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. |
Revenue Recognition | 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 (SP) during October 2017. The Company’s 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 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 SP 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, and TRICARE Retail Pharmacy Refunds Program (TRICARE). 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 SP. The Company uses the expected-value method for estimating rebates and estimates are adjusted quarterly to reflect actual experience. 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 further during the three months ended March 31, 2018. 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Pronouncements Adopted in 2018 In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers with amendments in 2015, 2016, and 2017. The amendment in this ASU provides guidance on the revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The core principle of this update provides guidance to identify the performance obligations under the contract(s) with a customer and how to allocate the transaction price to the performance obligations in the contract. It further provides guidance to recognize revenue when (or as) the entity satisfies a performance obligation. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. This standard replaces most existing revenue recognition guidance. The Company adopted the new standard effective January 1, 2018, using the full retrospective transition method. The Company has evaluated the effect the new guidance will have on its consolidated financial statements and determined the adoption of this guidance to have no material impact on amounts previously reported in its consolidated financial statements. ASU 2014-09 also codified the guidance on other assets and deferred costs relating to contracts with customers with the addition of ASC 340-40. This guidance relates to the accounting for costs of an entity to obtain and fulfill a contract to provide goods or services to the customer. Under the new guidance, an entity shall recognize as an asset the incremental costs of obtaining a contract with a customer if the entity expects to recover those costs. In the Company’s review of the various costs to obtain contracts with customers, it has determined that currently no significant costs are incurred that meet the capitalization criteria. The Company’s costs to fulfill contracts are outside the scope of ASC 340-40 and are typically expensed as incurred. In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718) – Scope of Modification Accounting. The new guidance clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. The Company adopted the new standard effective January 1, 2018, on a prospective basis. The adoption of this guidance did not have an impact on the Company’s consolidated financial statements or disclosures. New Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases . 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. Lessor accounting remains substantially unchanged with the exception that no leases entered into after the effective date will be classified as leveraged leases. For sale leaseback transactions, a sale will only be recognized if the criteria in the new revenue recognition standard are met. For public business entities, this guidance is effective for fiscal periods beginning after December 15, 2018 and interim periods thereafter. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. This guidance is effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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): March 31, 2018 Total Level 1 Level 2 Level 3 Assets: Money market $ 23,175 $ 23,175 $ — $ — Corporate debt 40,371 — 40,371 — U.S. Treasury notes 192,356 — 192,356 — Commercial paper 2,986 — 2,986 — Total assets measured at fair value $ 258,888 $ 23,175 $ 235,713 $ — Liabilities: Embedded derivative liability $ 494 $ — $ — $ 494 Total liabilities measured at fair value $ 494 $ — $ — $ 494 December 31, 2017 Total Level 1 Level 2 Level 3 Assets: Money market $ 68,501 $ 68,501 $ — $ — Corporate debt 23,471 — 23,471 — U.S. Treasury notes 61,646 — 61,646 — Total assets measured at fair value $ 153,618 $ 68,501 $ 85,117 $ — Liabilities: Embedded derivative liability $ 470 $ — $ — $ 470 Total liabilities measured at fair value $ 470 $ — $ — $ 470 |
Summary of the changes in the estimated fair value of the Company’s embedded derivative | 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, 2017 $ 470 Change in fair value included in interest and other income, net 24 Balance as of March 31, 2018 $ 494 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 March 31, 2018 and December 31, 2017 (in thousands): March 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 40,484 $ — $ (113 ) $ 40,371 U.S. Treasury notes 192,606 — (250 ) 192,356 Commercial paper 2,986 — — 2,986 Total $ 236,076 $ — $ (363 ) $ 235,713 Reported as: Short-term investments $ 147,850 $ — $ (262 ) $ 147,588 Long-term investments 88,226 — (101 ) 88,125 Total $ 236,076 $ — $ (363 ) $ 235,713 December 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 23,507 $ — $ (36 ) $ 23,471 U.S. Treasury notes 61,777 — (131 ) 61,646 Total $ 85,284 $ — $ (167 ) $ 85,117 Reported as: Short-term investments $ 82,280 $ — $ (154 ) $ 82,126 Long-term investments 3,004 — (13 ) 2,991 Total $ 85,284 $ — $ (167 ) $ 85,117 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consists of the following (in thousands): March 31, 2018 December 31, 2017 Raw materials $ 877 $ 859 Work-in-process 1,059 817 Finished goods 519 28 Total inventory $ 2,455 $ 1,704 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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): March 31, 2018 December 31, 2017 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (92,527 ) (97,353 ) Less: Payments made (60 ) — Carrying value of loans payable $ 107,413 $ 102,647 Less: Current portion of long-term debt (308 ) — Non-current portion of long-term debt $ 107,105 $ 102,647 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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: March 31, December 31, Common stock awards issued and outstanding 6,265,045 5,564,635 Authorized for future issuance under 2014 Equity Incentive Plan 1,788,884 1,723,733 Authorized for future issuance under 2016 Inducement Plan 618,513 188,715 Employee stock purchase plan 927,062 693,856 Total 9,599,504 8,170,939 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of allocation of total stock-based compensation expense | The following table reflects stock-based compensation expense recognized for the three months ended March 31, 2018 and 2017 (in thousands): Three Months Ended 2018 2017 Research and development $ 772 $ 821 Selling, general and administrative 2,969 2,063 Total stock-based compensation expense $ 3,741 $ 2,884 |
Description of Business (Detail
Description of Business (Details) | 3 Months Ended |
Mar. 31, 2018segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring basis - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Assets: | ||
Total assets measured at fair value | $ 258,888 | $ 153,618 |
Liabilities: | ||
Total liabilities measured at fair value | 494 | 470 |
Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 494 | 470 |
Level 1 | ||
Assets: | ||
Total assets measured at fair value | 23,175 | 68,501 |
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Level 1 | Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Level 2 | ||
Assets: | ||
Total assets measured at fair value | 235,713 | 85,117 |
Liabilities: | ||
Total liabilities measured at fair value | 0 | 0 |
Level 2 | Embedded derivative liability | ||
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 | 494 | 470 |
Level 3 | Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 494 | 470 |
Money market | ||
Assets: | ||
Total assets measured at fair value | 23,175 | 68,501 |
Money market | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 23,175 | 68,501 |
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 | 40,371 | 23,471 |
Corporate debt | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Corporate debt | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 40,371 | 23,471 |
Corporate debt | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury notes | ||
Assets: | ||
Total assets measured at fair value | 192,356 | 61,646 |
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 | 192,356 | 61,646 |
U.S. Treasury notes | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | $ 0 |
Commercial paper | ||
Assets: | ||
Total assets measured at fair value | 2,986 | |
Commercial paper | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | |
Commercial paper | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 2,986 | |
Commercial paper | Level 3 | ||
Assets: | ||
Total assets measured at fair value | $ 0 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Estimated Fair Value of Embedded Derivative (Details) - Level 3 - Long-term debt with embedded derivative $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance as of December 31, 2017 | $ 470 |
Change in fair value included in interest and other income, net | 24 |
Balance as of March 31, 2018 | $ 494 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers (Details) | Mar. 31, 2018USD ($) |
Fair value transfers between Level 1 and Level 2 | |
Fair value, assets, Level 1 to Level 2 transfers | $ 0 |
Fair value, assets, Level 2 to Level 1 transfers | 0 |
Fair value, liabilities, Level 1 to Level 2 transfers | 0 |
Fair value, liabilities, Level 2 to Level 1 transfers | $ 0 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Available-for-sale securities | ||
Amortized Cost | $ 236,076 | $ 85,284 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (363) | (167) |
Fair Value | 235,713 | 85,117 |
Short-term investments | ||
Available-for-sale securities | ||
Amortized Cost | 147,850 | 82,280 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (262) | (154) |
Fair Value | 147,588 | 82,126 |
Accrued interest | 900 | 600 |
Long-term investments | ||
Available-for-sale securities | ||
Amortized Cost | 88,226 | 3,004 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (101) | (13) |
Fair Value | 88,125 | 2,991 |
Accrued interest | $ 300 | 14 |
Long-term investments | Minimum | ||
Available-for-sale securities | ||
Maturity range of long term investment | 12 months | |
Long-term investments | Maximum | ||
Available-for-sale securities | ||
Maturity range of long term investment | 20 months | |
Corporate debt | ||
Available-for-sale securities | ||
Amortized Cost | $ 40,484 | 23,507 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (113) | (36) |
Fair Value | 40,371 | 23,471 |
U.S. Treasury notes | ||
Available-for-sale securities | ||
Amortized Cost | 192,606 | 61,777 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (250) | (131) |
Fair Value | 192,356 | $ 61,646 |
Commercial paper | ||
Available-for-sale securities | ||
Amortized Cost | 2,986 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 2,986 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 877 | $ 859 |
Work-in-process | 1,059 | 817 |
Finished goods | 519 | 28 |
Total inventory | $ 2,455 | $ 1,704 |
License Agreements (Details)
License Agreements (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Nov. 30, 2012 | Mar. 31, 2018 | |
License Agreements | ||
Period describing the commercial launch of dose | 15 years | |
License agreement | ||
License Agreements | ||
Upfront payment received | $ 65 | |
Maximum total additional cash payments receivable upon achievement of certain development and regulatory milestones | $ 95 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | Mar. 31, 2018ft²claim | Jan. 16, 2018USD ($)ft² |
Loss Contingencies [Line Items] | ||
Number of claims | claim | 0 | |
Emeryville, CA | ||
Loss Contingencies [Line Items] | ||
Lease agreement square footage (in sqft) | ft² | 18,500 | |
Lessee, operating lease, rentable square feet (in sqft) | ft² | 37,626 | |
Lessee, operating lease, tenet improvement allowance | $ 1,100 | |
Lessee, operating lease, initial monthly lease payment | 160 | |
Lessee, operating lease, monthly lease payment, final year of agreement | $ 197 |
Long-term Debt (Details)
Long-term Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
May 31, 2017 | Mar. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | |
Level 3 | ||||
Debt Instrument [Line Items] | ||||
Long-term debt, fair value | $ 111,300,000 | |||
HCRP | Royalty-backed loan agreement | ||||
Debt Instrument [Line Items] | ||||
Proceeds from issuance of debt | $ 35,000,000 | $ 65,000,000 | ||
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 | |||
Payment of debt issuance costs | $ 800,000 | |||
Interest expense | $ 4,800,000 | $ 0 | ||
Effective interest rate | 19.90% | |||
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 | Mar. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Long-term debt | $ 107,105 | $ 102,647 |
HCRP | Royalty-backed loan agreement | ||
Debt Instrument [Line Items] | ||
Total repayment obligation | 200,000 | 200,000 |
Less: Interest to be accreted in future periods | (92,527) | (97,353) |
Less: Payments made | (60) | 0 |
Carrying value of loans payable | 107,413 | 102,647 |
Less: Current portion of long-term debt | (308) | 0 |
Long-term debt | $ 107,105 | $ 102,647 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 1 Months Ended | 3 Months Ended | |||||
Jan. 31, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($)voteshares | Mar. 31, 2017USD ($) | Dec. 31, 2017shares | Nov. 30, 2017shares | May 31, 2017USD ($) | Mar. 31, 2016shares | |
Shareholders' Equity | |||||||
Authorized shares of common stock (in shares) | 100,000,000 | 100,000,000 | |||||
Dividends declared | $ | $ 0 | ||||||
Number of votes per share | vote | 1 | ||||||
Net proceeds from follow-on public offering | $ | $ 134,433,000 | $ 0 | |||||
Total common stock reserved for future issuance (in shares) | 9,599,504 | 8,170,939 | |||||
2016 Inducement Plan | |||||||
Shareholders' Equity | |||||||
Total common stock reserved for future issuance (in shares) | 1,350,000 | 450,000 | |||||
Cowen | |||||||
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% | ||||||
Employee Stock Purchase Plan | |||||||
Shareholders' Equity | |||||||
Total common stock reserved for future issuance (in shares) | 927,062 | 693,856 | |||||
Stock options | |||||||
Shareholders' Equity | |||||||
Total common stock reserved for future issuance (in shares) | 6,265,045 | 5,564,635 | |||||
Stock options | 2014 Equity Incentive Plan | |||||||
Shareholders' Equity | |||||||
Authorized for future issuance (in shares) | 1,788,884 | 1,723,733 | |||||
Stock options | 2016 Inducement Plan | |||||||
Shareholders' Equity | |||||||
Authorized for future issuance (in shares) | 618,513 | 188,715 | |||||
Common Stock | |||||||
Shareholders' Equity | |||||||
Sale of shares under the sales agreement (in shares) | 3,450,000 | ||||||
Share price (in dollars per share) | $ / shares | $ 41.50 | ||||||
Net proceeds from follow-on public offering | $ | $ 134,300,000 | ||||||
Common Stock | Stock options | Over-Allotment Option | |||||||
Shareholders' Equity | |||||||
Sale of shares under the sales agreement (in shares) | 450,000 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 11 Months Ended | 12 Months Ended | ||||
Nov. 30, 2017 | Jan. 31, 2017 | Mar. 31, 2018 | Mar. 31, 2017 | Nov. 30, 2017 | Dec. 31, 2017 | Jan. 31, 2018 | Mar. 31, 2016 | |
Stock Option Plans | ||||||||
Company’s common stock available for issuance (in shares) | 9,599,504 | 8,170,939 | ||||||
Stock-based compensation capitalized in inventory | $ 49,000 | $ 0 | ||||||
Employee Stock Purchase Plan | ||||||||
Stock Option Plans | ||||||||
Increase in common stock available for issuance (in shares) | 233,206 | |||||||
Employee Stock Purchase Plan | Maximum | ||||||||
Stock Option Plans | ||||||||
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% | |||||||
2014 Equity Incentive Plan | ||||||||
Stock Option Plans | ||||||||
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) | 932,822 | |||||||
2016 Inducement Plan | ||||||||
Stock Option Plans | ||||||||
Company’s common stock available for issuance (in shares) | 1,350,000 | 1,350,000 | 450,000 | |||||
Company’s additional common stock available for issuance (in shares) | 450,000 | 450,000 | 900,000 |
Stock-Based Compensation - Inco
Stock-Based Compensation - Income Statement Location (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Stock-based compensation expense | ||
Total stock-based compensation expense | $ 3,741 | $ 2,884 |
Research and development | ||
Stock-based compensation expense | ||
Total stock-based compensation expense | 772 | 821 |
Selling, general and administrative | ||
Stock-based compensation expense | ||
Total stock-based compensation expense | $ 2,969 | $ 2,063 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Earnings Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 5,734 | 5,688 |