Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 30, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | Adamas Pharmaceuticals Inc | |
Entity Central Index Key | 0001328143 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding (in shares) | 27,533,211 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 58,936 | $ 56,605 |
Available-for-sale securities | 131,699 | 154,265 |
Accounts receivable, net | 7,498 | 5,511 |
Inventory | 5,202 | 5,121 |
Prepaid expenses and other current assets | 6,465 | 6,871 |
Total current assets | 209,800 | 228,373 |
Property and equipment, net | 3,294 | 3,652 |
Operating lease right-of-use assets | 7,368 | 0 |
Prepaid expenses and other non-current assets | 2,764 | 2,789 |
Total assets | 223,226 | 234,814 |
Current liabilities | ||
Accounts payable | 10,242 | 6,570 |
Accrued liabilities | 16,609 | 15,530 |
Current portion of long-term debt | 1,527 | 1,664 |
Other current liabilities | 1,452 | 512 |
Total current liabilities | 29,830 | 24,276 |
Long-term debt | 119,661 | 117,457 |
Long-term portion of operating lease liabilities | 8,366 | 0 |
Other non-current liabilities | 1,453 | 3,196 |
Total liabilities | 159,310 | 144,929 |
Commitments and Contingencies (Note 8) | ||
Stockholders’ equity | ||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at March 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.001 par value — 100,000,000 shares authorized, 27,519,979 and 27,434,358 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 32 | 32 |
Additional paid-in capital | 436,274 | 432,815 |
Accumulated other comprehensive loss | (34) | (264) |
Accumulated deficit | (372,356) | (342,698) |
Total stockholders’ equity | 63,916 | 89,885 |
Total liabilities and stockholders’ equity | $ 223,226 | $ 234,814 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in 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) | 27,519,979 | 27,434,358 |
Common stock, outstanding (in shares) | 27,519,979 | 27,434,358 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Costs and operating expenses: | ||
Cost of product sales | $ 413 | $ 25 |
Research and development | 10,214 | 7,188 |
Selling, general and administrative, net | 27,688 | 26,363 |
Total costs and operating expenses | 38,315 | 33,576 |
Loss from operations | (26,650) | (31,023) |
Interest and other income, net | 723 | 878 |
Interest expense | (3,731) | (4,826) |
Net loss | $ (29,658) | $ (34,971) |
Net loss per share, basic and diluted (in dollars per share) | $ (1.08) | $ (1.35) |
Weighted average shares used in computing net loss per share, basic and diluted (in shares) | 27,453 | 25,861 |
Product sales | ||
Revenues: | ||
Total revenues | $ 11,665 | $ 2,553 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (29,658) | $ (34,971) |
Unrealized gain (loss) on available-for-sale securities | 230 | (196) |
Comprehensive loss | $ (29,428) | $ (35,167) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders Equity (unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2017 | 23,320,551 | ||||
Beginning balance at Dec. 31, 2017 | $ 66,126 | $ 28 | $ 277,964 | $ (167) | $ (211,699) |
Increase (decrease) in shareholders' equity | |||||
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs (in shares) | 3,450,000 | ||||
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs | 134,264 | $ 4 | 134,260 | ||
Exercise of stock options (in shares) | 136,154 | ||||
Exercise of stock options | $ 590 | $ 0 | 590 | ||
Restricted stock units vested (in shares) | 51,309 | ||||
Restricted stock units vested | $ 0 | ||||
Net unrealized (loss) gain on available-for-sale securities | (196) | (196) | |||
Stock-based compensation | 3,790 | 3,790 | |||
Net loss | (34,971) | (34,971) | |||
Ending balance (in shares) at Mar. 31, 2018 | 26,958,014 | ||||
Ending balance at Mar. 31, 2018 | 169,603 | $ 32 | 416,604 | (363) | (246,670) |
Beginning balance (in shares) at Dec. 31, 2018 | 27,434,358 | ||||
Beginning balance at Dec. 31, 2018 | 89,885 | $ 32 | 432,815 | (264) | (342,698) |
Increase (decrease) in shareholders' equity | |||||
Exercise of stock options (in shares) | 18,230 | ||||
Exercise of stock options | $ 49 | $ 0 | 49 | ||
Restricted stock units vested (in shares) | 67,391 | ||||
Restricted stock units vested | $ 0 | ||||
Net unrealized (loss) gain on available-for-sale securities | 230 | 230 | |||
Stock-based compensation | 3,410 | 3,410 | |||
Net loss | (29,658) | (29,658) | |||
Ending balance (in shares) at Mar. 31, 2019 | 27,519,979 | ||||
Ending balance at Mar. 31, 2019 | $ 63,916 | $ 32 | $ 436,274 | $ (34) | $ (372,356) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (29,658) | $ (34,971) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation | 368 | 383 |
Stock-based compensation | 3,384 | 3,741 |
Accretion of interest expense | 3,731 | 4,826 |
Change in fair value of embedded derivative liability | 101 | 24 |
Net accretion of discounts and amortization of premiums of available-for-sale securities | (337) | (53) |
Changes in assets and liabilities | ||
Accrued interest of available-for-sale securities | (56) | (643) |
Accounts receivable, net | (1,987) | (1,246) |
Inventory | 86 | (558) |
Prepaid expenses and other assets | 347 | 171 |
Operating lease right-of-use assets | 198 | 0 |
Accounts payable | 3,319 | 3,944 |
Current portion of long-term debt | (1,664) | (60) |
Long-term portion of operating lease liabilities | (234) | 0 |
Accrued liabilities and other liabilities | 1,485 | (357) |
Net cash used in operating activities | (20,917) | (24,799) |
Cash flows from investing activities | ||
Purchases of property and equipment | (7) | (502) |
Purchases of available-for-sale securities | (20,811) | (178,896) |
Maturities of available-for-sale securities | 44,000 | 28,800 |
Net cash provided by (used in) investing activities | 23,182 | (150,598) |
Cash flows from financing activities | ||
Proceeds from public offerings, net of offering costs | 0 | 134,433 |
Proceeds from issuance of common stock upon exercise of stock options | 66 | 590 |
Net cash provided by financing activities | 66 | 135,023 |
Net increase (decrease) in cash and cash equivalents | 2,331 | (40,374) |
Cash and cash equivalents at beginning of period | 56,605 | 91,316 |
Cash and cash equivalents at end of period | 58,936 | 50,942 |
Supplemental disclosure of noncash activities | ||
Right-of-use assets obtained in exchange for operating lease liabilities | 7,566 | 0 |
Purchases of inventory in accounts payable and accrued expenses | 334 | 163 |
Property and equipment in accounts payable and accrued expense | 10 | 106 |
Stock-based compensation capitalized in inventory | 26 | 49 |
Public offering costs in accounts payable and accrued expense | $ 0 | $ 169 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS Adamas Pharmaceuticals, Inc. (the “Company”) focuses on pioneering time-dependent medicines to meaningfully enhance the daily living experience of those affected by CNS disorders. 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 medication indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company is also advancing its Phase 3 development program of ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. The Company’s goal is to lessen the burden of chronic CNS disorders 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, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying 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, 2018 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, 2019 , 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, 2018 , 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, 2018 . Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) , using the modified retrospective method with a cumulative-effect adjustment as of January 1, 2019, in accordance with ASU No. 2018-11, Leases (Topic 842): Targeted Improvements . Other than the adoption of the new accounting guidance, the Company’s critical accounting policies have not changed materially from December 31, 2018 . Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition and variable consideration, lease assets and liabilities, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, inventory, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates. Leases The Company determines if an arrangement is, or contains, a lease at inception. An arrangement is, or contains, a lease if it conveys the right to control the use of identified property, plant or equipment (i.e., an identified asset) for a period of time in exchange for consideration. The Company’s arrangements determined to be or contain a lease include explicitly or implicitly identified assets where the Company has the right to substantially all of the economic benefits of the assets and has the ability to direct how and for what purpose the assets are used during the lease term. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its condensed consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at commencement date as the Company’s leases generally do not provide an implicit rate. The operating lease ROU assets also include any lease payments made (including any prepaid rents and initial direct costs) and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense for lease payments is recognized on a straight-line basis over the expected lease term. The Company has lease agreements with lease and non-lease components, which are accounted for separately. Reclassification Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to current period presentation. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) . The authoritative guidance significantly amends the current accounting for leases. Under the new provisions, all lessees will report a right-of-use asset and a liability for the obligation to make payments for all leases with the exception of those leases with a term of 12 months or less. All other leases will fall into one of two categories: (i) a financing lease or (ii) an operating lease. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842 (Leases) , which amends narrow aspects of the guidance issued in the amendments in ASU 2016-02, and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements , which allows entities to recognize a cumulative-effect adjustment from the application of ASU 2016-02 to the opening balance of retained earnings in the period of adoption. Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective method as of January 1, 2019 and will not restate comparative periods. The Company elected the optional package of practical expedients, which allowed the Company to not reassess: (i) whether any expired or existing contracts are considered or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain policy elections, including a policy to not separate lease and non-lease components, which the Company did not elect. The adjustments due to the adoption of Topic 842 primarily related to the recognition of an operating lease right-of-use asset and operating lease liability for the lease. The impact on the condensed consolidated balance sheet as of January 1, 2019, was as follows (in thousands): December 31, 2018 Adjustment due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use assets $ — $ 7,566 $ 7,566 Other current liabilities 512 768 1,280 Long-term portion of operating lease liabilities — 8,643 8,643 Other non-current liabilities 3,196 (1,844 ) 1,352 In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting , which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Previously, accounting for share-based payments to employees was covered by ASC Topic 718 while accounting for such payments to non-employees was covered by ASC Subtopic 505-50. Under this new guidance, both sets of awards, for employees and non-employees, will essentially follow the same model, with small variations related to determining the term assumption when valuing a non-employee award as well as a different expense attribution model for non-employee awards as opposed to employee awards. This guidance is effective for fiscal years beginning after December 15, 2018. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments , and in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. 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. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement , which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. 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, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS In accordance with ASC 820-10, Fair Value Measurements and Disclosures, the Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows: • Level 1 inputs, which include quoted prices in active markets for identical assets or liabilities; • Level 2 inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For available-for-sale securities, the Company reviews trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and • Level 3 inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgment or estimation. The following table represents the fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis (in thousands): March 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market $ 13,420 $ 13,420 $ — $ — Corporate debt 22,911 — 22,911 — U.S. Treasury notes 105,807 — 105,807 — Commercial paper 2,981 — 2,981 — Total assets measured at fair value $ 145,119 $ 13,420 $ 131,699 $ — Liabilities: Embedded derivative liability $ 1,453 $ — $ — $ 1,453 Total liabilities measured at fair value $ 1,453 $ — $ — $ 1,453 December 31, 2018 Total Level 1 Level 2 Level 3 Assets: Money market $ 17,789 $ 17,789 $ — $ — Corporate debt 19,792 — 19,792 — U.S. Treasury notes 131,512 — 131,512 — Commercial paper 2,961 — 2,961 — Total assets measured at fair value $ 172,054 $ 17,789 $ 154,265 $ — Liabilities: Embedded derivative liability $ 1,352 $ — $ — $ 1,352 Total liabilities measured at fair value $ 1,352 $ — $ — $ 1,352 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. Corporate debt, U.S. Treasury 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 9 “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, 2018 $ 1,352 Change in fair value included in interest and other income, net 101 Balance as of March 31, 2019 $ 1,453 There were no transfers between any of the levels of the fair value hierarchy during the three months ended March 31, 2019 . |
Investments
Investments | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 and December 31, 2018 (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 22,909 $ 7 $ (5 ) $ 22,911 U.S. Treasury notes 105,843 34 (70 ) 105,807 Commercial paper 2,981 — — 2,981 Total $ 131,733 $ 41 $ (75 ) $ 131,699 Reported as: Short-term investments $ 131,733 $ 41 $ (75 ) $ 131,699 Long-term investments — — — — Total $ 131,733 $ 41 $ (75 ) $ 131,699 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 19,833 $ — $ (41 ) $ 19,792 U.S. Treasury notes 131,735 10 (233 ) 131,512 Commercial paper 2,961 — — 2,961 Total $ 154,529 $ 10 $ (274 ) $ 154,265 Reported as: Short-term investments $ 154,529 $ 10 $ (274 ) $ 154,265 Long-term investments — — — — Total $ 154,529 $ 10 $ (274 ) $ 154,265 Short-term investments include accrued interest of $0.6 million and $0.5 million as of March 31, 2019 and December 31, 2018 , respectively. The Company has not incurred any realized gains or losses on investments for the three months ended March 31, 2019 and 2018 . Investments are classified as short-term or long-term depending on the underlying investment’s maturity date. The Company had no investments with a maturity date greater than 12 months as of March 31, 2019 and December 31, 2018 . All investments with unrealized losses at March 31, 2019 have been in a loss position for less than twelve months or the loss is not material and were temporary in nature. The Company does not intend to sell the investments that are in an unrealized loss position before recovery of their amortized cost basis. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY The Company began capitalizing inventory in August 2017 once the FDA approved GOCOVRI. Inventory consists of the following (in thousands): March 31, 2019 December 31, 2018 Raw materials $ 1,293 $ 1,330 Work-in-process 2,411 2,174 Finished goods 1,498 1,617 Total inventory $ 5,202 $ 5,121 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | LEASES Lease Commitments The Company performed an evaluation of its contracts in accordance with Topic 842 and determined that, except for its facility, vehicle fleet, and office equipment leases, described below, none of its other contracts contain a lease. The Company evaluated all its leases and determined they were operating leases. In January 2018, the Company amended its Emeryville, California, office facility lease agreement to extend the term to April 30, 2025, and relocate and expand its office space to 37,626 rentable square feet within the same building. The lease contains an option to extend the term for one additional five -year period. The extension option has not been considered in the determination of the right-of-use asset or the lease liability as the Company did not consider it reasonably certain that it would exercise such option. The lease provides for a tenant improvement allowance of approximately $1.1 million , which the Company fully utilized during the third quarter of 2018. In 2018, the Company entered into a three -year lease for office equipment that commenced in June 2018 and will be required to make cash payments totaling $0.2 million during the term of the lease. As of March 31, 2019 , the Company had additional operating leases that have not yet commenced related to a three -year master vehicle lease agreement entered into in March 2019. The term for each leased vehicle is for a period of 12 months , which commences upon the delivery of the vehicle. As of March 31, 2019 , none of the leased vehicles have been delivered. Delivery of the vehicles is expected to be complete during the second quarter of 2019. Supplemental balance sheet information related to operating leases were as follows (in thousands): March 31, 2019 December 31, 2018 Assets Operating lease right-of-use assets $ 7,368 $ — Total right-of-use assets $ 7,368 $ — Liabilities Current portion included in other current liabilities $ 1,039 $ — Long-term portion of operating lease liabilities 8,366 — Total operating lease liabilities $ 9,405 $ — The components of lease costs, which were included in operating expenses in its condensed consolidated statements of operations, were as follows (in thousands): Three Months Ended 2019 2018 Operating lease cost $ 458 $ — Variable lease cost 28 — Total lease cost $ 486 $ — As of March 31, 2019 , the maturities of operating lease liabilities were as follows (in thousands): Operating leases (1) 2019 (remaining) $ 1,504 2020 2,057 2021 2,086 2022 2,118 2023 2,181 Thereafter 3,011 Total lease payments 12,957 Less: Imputed interest (3,552 ) Operating lease liabilities $ 9,405 (1) The table above does not include any legally binding minimum lease payments for leases signed but not yet commenced of approximately $1.6 million . As of March 31, 2019 , the weighted average remaining lease term is 6.0 years and the weighted average operating discount rate used to determine the operating lease liability was 11.1% . ASC 840 Disclosure The Company elected the alternative modified transition method and included the following tables previously disclosed. As of December 31, 2018, future minimum lease payments under the non-cancelable facility operating lease, were as follows (in thousands): Amount 2019 $ 1,938 2020 1,996 2021 2,056 2022 2,118 2023 2,181 Thereafter 3,011 Total $ 13,300 |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
License Agreements | |
License Agreements | LICENSE AGREEMENTS In November 2012, the Company granted Forest Laboratories Holdings Limited “Forest”, an indirect wholly-owned subsidiary of Allergan plc (collectively “Allergan”) an exclusive license, with right to sublicense, certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells Namzaric ® and Namenda XR ® for the treatment of moderate to severe dementia related to Alzheimer’s disease. Pursuant to the agreement, Allergan made an upfront payment of $65.0 million . The Company earned and received additional cash payments totaling $95.0 million upon achievement by Allergan of certain development and regulatory milestones. Under the agreement, external costs incurred related to the prosecution and litigation of intellectual property rights are reimbursable. Reimbursable external costs are recorded as a reduction to selling, general and administrative, net. For the three months ended March 31, 2019 and 2018 , 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; however, Allergan’s obligation to pay royalties for any product covered by the license is eliminated in any quarter where there is significant competition from generics. Beginning in May 2020, the Company will be entitled to receive royalties in the low to mid-teens from Allergan for sales of Namzaric 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. Beginning in June 2018, the Company was entitled to receive royalties in the low to mid-single digits for sales of Namenda XR in the United States. The Company does not expect to receive royalties on net sales of Namenda XR, due to the entry of generic versions of Namenda XR. Royalties under the license agreement will be recognized when the related sales occur, in accordance with the sales-based royalty exception. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Purchase Commitments The Company has entered into agreements for the supply of API and the manufacture of commercial supply of GOCOVRI, with Moehs Ibérica, S.L. and Catalent Pharma Solutions, LLC, respectively. Under the terms of the agreements, the Company will supply the vendors with non-cancelable firm commitment purchase orders and must meet certain annual minimum requirements for the manufacture of commercial supply of GOCOVRI. 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. In 2018 and as of the date of this filing, multiple generic companies have launched generic versions of Namenda XR. As of the date of this filing, a number of companies have submitted ANDAs including one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(iv) to the FDA requesting approval to manufacture and market generic versions of Namzaric, on which the Company is entitled to receive royalties from Forest beginning in May 2020. As of the date of this filing, the Company and Forest have settled with all such Namzaric ANDA filers, including all first filers on all the available dosage forms of Namzaric. Subject to those agreements, the earliest date on which any of these agreements grants a license to market generic version of Namzaric is January 1, 2025 or in the alternative, an option to launch an authorized generic version of Namzaric beginning on January 1, 2026, or earlier in certain circumstances. The Company and Forest intend to continue to enforce the patents associated with Namzaric. On February 16, 2018, Osmotica Pharmaceuticals LLC and Vertical Pharmaceuticals LLC (“Osmotica”) filed an action against the Company in U.S. District Court for the state of Delaware, requesting a declaratory judgment that Osmotica’s newly-approved product Osmolex ER™ (amantadine) extended release tablets does not infringe certain of the Company’s patents. On September 20, 2018, the Company filed its first amended answer including infringement counterclaims against Osmotica asserting Osmotica has infringed nine Company patents under 35 U.S.C. §§ 271(a), (b), and/or (c) and 35 U.S.C. § 271(e)(2)(A) and seeking various forms of relief, including damages, treble damages, injunctive relief, and an order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of any approval of Osmotica’s NDA for Osmolex ER™ be a date that is not earlier than the latest expiration date of the Company patents involved in the lawsuit. This action is ongoing, with a Markman hearing regarding patent claims construction scheduled for June 17, 2019. On March 13, 2018, the FDA’s New Paragraph IV Certifications list was updated to reflect that an ANDA seeking authorization from the FDA to manufacture, use, or sell a generic version of GOCOVRI ® (amantadine) extended release capsules, containing one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“paragraph IV certification”), was submitted to the FDA on January 16, 2018, and has been accepted for filing. Subsequent to this date, the Company received a letter from attorneys representing Sandoz, Inc. (“Sandoz”) dated March 29, 2018, notifying it that Sandoz filed an ANDA for Amantadine Extended-Release Capsules, 137 mg that contains paragraph IV certifications seeking to obtain approval to engage in the commercial manufacture, use or sale of Amantadine Extended-Release Capsules, 137 mg before the expiration of U.S. Patent Nos. 8,389,578; 8,741,343; 8,796,337; 8,889,740; 8,895,614; 8,895,615; 8,895,616; 8,895,617; 8,895,618; 9,867,791; 9,867,792; 9,867,793; and 9,877,933. On May 10, 2018, the Company filed a lawsuit against Sandoz alleging infringement of the patents against Sandoz in the United States District Court for the District of New Jersey. On July 30, 2018, Sandoz filed its answer, defenses, and counterclaims asserting that the asserted Company patents are invalid and not infringed in response to the Company’s May 10, 2018 complaint. This action is ongoing. On April 1, 2019, the Company was served with a complaint filed in the United States District Court for the Northern District of California (Case No. 3:18-cv-03018-JCS) against the Company and several Allergan entities alleging violations of Federal and state false claims acts (“FCA”) in connection with the commercialization of Namenda XR and Namzaric by Allergan. The lawsuit is a qui tam complaint brought by a named individual, Zachary Silbersher, asserting rights of the Federal government and various state governments. The lawsuit was originally filed in May 2018 under seal, and the Company became aware of the lawsuit when it was served. The complaint alleges that patents held by Allergan and the Company covering Namenda XR and Namzaric were procured through fraud on the United States Patent and Trademark Office and that these patents were asserted against potential generic manufacturers of Namenda XR and Namzaric to prevent the generic manufacturers from entering the market, thereby wrongfully excluding generic competition resulting in an artificially high price being charged to government payors. The Company’s patents in question were licensed exclusively to Forest. The complaint includes a claim for damages of “potentially more than $2.5 billion dollars,” treble damages “under the federal FCA and most of the State FCAs,” and “statutory penalties that can be assessed for each false claim.” The federal and state governments have declined to intervene in this action. To the Company’s knowledge, the individual plaintiff is pursuing the lawsuit in his individual capacity. The Company believes it has strong factual and legal defenses and intends to defend itself vigorously. We are in the early stages of this litigation. 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 no t currently party to any material legal proceedings. |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | LONG-TERM DEBT Royalty-Backed Loan Agreement In May 2017, the Company, through a new wholly-owned subsidiary, Adamas Pharma, LLC, entered into a Royalty-Backed Loan with HCRP, whereby the Company initially borrowed $35.0 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 received in the fourth quarter 2017. To the extent that royalties are insufficient to pay interest in full during the first nine quarters of the loan, any unpaid portion of the quarterly interest payment will be added to the principal amount of the loans. In connection with the Royalty-Backed Loan, in 2017 the Company paid HCRP a lender expense amount of $0.4 million and incurred additional debt issuance costs totaling $ 0.8 million . The lender expense and additional debt issuance costs have been recorded as a debt discount and are being amortized and recorded as interest expense over the estimated term of the loan using the effective interest method. The Company recorded interest expense, including amortization of the debt discount, related to the Royalty-Backed Loan, of $3.7 million and $4.8 million for the three months ended March 31, 2019 , and March 31, 2018 , 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, 2019 on the amounts borrowed under the Royalty-Backed Loan, including the amortization of the debt discount, was 14.3% . 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, 2019 December 31, 2018 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (74,529 ) (78,261 ) Less: Payments made (4,283 ) (2,618 ) Carrying value of loans payable $ 121,188 $ 119,121 Less: Current portion of long-term debt (1,527 ) (1,664 ) Non-current portion of long-term debt $ 119,661 $ 117,457 The estimated fair value of the long-term debt, as measured using Level 3 inputs, approximates $100.6 million as of March 31, 2019 . The estimated fair value was calculated in the same methodology as the valuation of the embedded derivative as described further in Note 3. 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, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Common Stock The amended and restated certificate of incorporation authorizes the Company to issue 100,000,000 shares of common stock. Common stockholders are entitled to dividends as and when declared by the board of directors, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. Each share of common stock is entitled to one vote. Public Offering In January 2018, the Company completed a follow-on public offering of 3,450,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 450,000 shares of common stock, at an offering price of $41.50 per share. Proceeds from the follow-on public offering were approximately $134.3 million , net of underwriting discounts and offering-related transaction costs. Sales Agreement In 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, 2019 , no shares have been sold under the Sales Agreement. Shares Reserved for Future Issuance Shares of the Company’s common stock reserved for future issuance are as follows: March 31, 2019 December 31, 2018 Common stock awards issued and outstanding 6,548,752 5,949,436 Authorized for future issuance under 2014 Equity Incentive Plan 2,340,730 1,814,179 Authorized for future issuance under 2016 Inducement Plan 848,326 512,440 Employee stock purchase plan 1,121,449 847,105 Total 10,859,257 9,123,160 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Stock Compensation Plans In January 2019 , 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, 2018 , or 1,097,374 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, November 2017, and March 2019, an amendment to the Inducement Plan was approved to increase the number of shares available for issuance an additional 450,000 shares, for a total of 1,350,000 , resulting in a total of 1,800,000 shares of common stock issuable under the Inducement Plan. Employee Stock Purchase Plan In January 2019 , 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, 2018 , or 274,344 shares. Stock-Based Compensation Expense The following table reflects stock-based compensation expense recognized for the three months ended March 31, 2019 and 2018 (in thousands): Three Months Ended 2019 2018 Research and development $ 590 $ 772 Selling, general and administrative 2,794 2,969 Total stock-based compensation expense $ 3,384 $ 3,741 Stock-based compensation of $26,000 and $49,000 was capitalized into inventory for the three months ended March 31, 2019 and March 31, 2018 . 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, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares outstanding due to the Company’s net loss position. The following total outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented, because including them would have been anti-dilutive (in thousands): Three Months Ended 2019 2018 Options to purchase common stock 5,741 5,753 Restricted stock units 808 512 Total 6,549 6,265 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2018 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, 2019 , 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, 2018 , 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, 2018 . Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) , using the modified retrospective method with a cumulative-effect adjustment as of January 1, 2019, in accordance with ASU No. 2018-11, Leases (Topic 842): Targeted Improvements . Other than the adoption of the new accounting guidance, the Company’s critical accounting policies have not changed materially from December 31, 2018 . |
Use of Estimates | Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition and variable consideration, lease assets and liabilities, clinical trial accruals, fair value of assets and liabilities including short-term and long-term classification, embedded derivatives, income taxes, inventory, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates. |
Leases | Leases The Company determines if an arrangement is, or contains, a lease at inception. An arrangement is, or contains, a lease if it conveys the right to control the use of identified property, plant or equipment (i.e., an identified asset) for a period of time in exchange for consideration. The Company’s arrangements determined to be or contain a lease include explicitly or implicitly identified assets where the Company has the right to substantially all of the economic benefits of the assets and has the ability to direct how and for what purpose the assets are used during the lease term. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its condensed consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at commencement date as the Company’s leases generally do not provide an implicit rate. The operating lease ROU assets also include any lease payments made (including any prepaid rents and initial direct costs) and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense for lease payments is recognized on a straight-line basis over the expected lease term. The Company has lease agreements with lease and non-lease components, which are accounted for separately. |
Reclassifications | Reclassification Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to current period presentation. |
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) . The authoritative guidance significantly amends the current accounting for leases. Under the new provisions, all lessees will report a right-of-use asset and a liability for the obligation to make payments for all leases with the exception of those leases with a term of 12 months or less. All other leases will fall into one of two categories: (i) a financing lease or (ii) an operating lease. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842 (Leases) , which amends narrow aspects of the guidance issued in the amendments in ASU 2016-02, and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements , which allows entities to recognize a cumulative-effect adjustment from the application of ASU 2016-02 to the opening balance of retained earnings in the period of adoption. Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective method as of January 1, 2019 and will not restate comparative periods. The Company elected the optional package of practical expedients, which allowed the Company to not reassess: (i) whether any expired or existing contracts are considered or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain policy elections, including a policy to not separate lease and non-lease components, which the Company did not elect. The adjustments due to the adoption of Topic 842 primarily related to the recognition of an operating lease right-of-use asset and operating lease liability for the lease. The impact on the condensed consolidated balance sheet as of January 1, 2019, was as follows (in thousands): December 31, 2018 Adjustment due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use assets $ — $ 7,566 $ 7,566 Other current liabilities 512 768 1,280 Long-term portion of operating lease liabilities — 8,643 8,643 Other non-current liabilities 3,196 (1,844 ) 1,352 In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting , which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Previously, accounting for share-based payments to employees was covered by ASC Topic 718 while accounting for such payments to non-employees was covered by ASC Subtopic 505-50. Under this new guidance, both sets of awards, for employees and non-employees, will essentially follow the same model, with small variations related to determining the term assumption when valuing a non-employee award as well as a different expense attribution model for non-employee awards as opposed to employee awards. This guidance is effective for fiscal years beginning after December 15, 2018. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments , and in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. 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. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement , which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect the new guidance will have on its consolidated financial statements. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of recently adopted accounting pronouncements | The impact on the condensed consolidated balance sheet as of January 1, 2019, was as follows (in thousands): December 31, 2018 Adjustment due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use assets $ — $ 7,566 $ 7,566 Other current liabilities 512 768 1,280 Long-term portion of operating lease liabilities — 8,643 8,643 Other non-current liabilities 3,196 (1,844 ) 1,352 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis | The following table represents the fair value hierarchy for the Company’s financial assets and liabilities which require fair value measurement on a recurring basis (in thousands): March 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market $ 13,420 $ 13,420 $ — $ — Corporate debt 22,911 — 22,911 — U.S. Treasury notes 105,807 — 105,807 — Commercial paper 2,981 — 2,981 — Total assets measured at fair value $ 145,119 $ 13,420 $ 131,699 $ — Liabilities: Embedded derivative liability $ 1,453 $ — $ — $ 1,453 Total liabilities measured at fair value $ 1,453 $ — $ — $ 1,453 December 31, 2018 Total Level 1 Level 2 Level 3 Assets: Money market $ 17,789 $ 17,789 $ — $ — Corporate debt 19,792 — 19,792 — U.S. Treasury notes 131,512 — 131,512 — Commercial paper 2,961 — 2,961 — Total assets measured at fair value $ 172,054 $ 17,789 $ 154,265 $ — Liabilities: Embedded derivative liability $ 1,352 $ — $ — $ 1,352 Total liabilities measured at fair value $ 1,352 $ — $ — $ 1,352 |
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, 2018 $ 1,352 Change in fair value included in interest and other income, net 101 Balance as of March 31, 2019 $ 1,453 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of amortized cost, unrealized gain and loss and the fair value of available-for-sale securities | The following table is a summary of amortized cost, unrealized gain and loss, and the fair value of available-for-sale securities as of March 31, 2019 and December 31, 2018 (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 22,909 $ 7 $ (5 ) $ 22,911 U.S. Treasury notes 105,843 34 (70 ) 105,807 Commercial paper 2,981 — — 2,981 Total $ 131,733 $ 41 $ (75 ) $ 131,699 Reported as: Short-term investments $ 131,733 $ 41 $ (75 ) $ 131,699 Long-term investments — — — — Total $ 131,733 $ 41 $ (75 ) $ 131,699 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments: Corporate debt $ 19,833 $ — $ (41 ) $ 19,792 U.S. Treasury notes 131,735 10 (233 ) 131,512 Commercial paper 2,961 — — 2,961 Total $ 154,529 $ 10 $ (274 ) $ 154,265 Reported as: Short-term investments $ 154,529 $ 10 $ (274 ) $ 154,265 Long-term investments — — — — Total $ 154,529 $ 10 $ (274 ) $ 154,265 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consists of the following (in thousands): March 31, 2019 December 31, 2018 Raw materials $ 1,293 $ 1,330 Work-in-process 2,411 2,174 Finished goods 1,498 1,617 Total inventory $ 5,202 $ 5,121 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of balance sheet classification of operating lease liabilities | Supplemental balance sheet information related to operating leases were as follows (in thousands): March 31, 2019 December 31, 2018 Assets Operating lease right-of-use assets $ 7,368 $ — Total right-of-use assets $ 7,368 $ — Liabilities Current portion included in other current liabilities $ 1,039 $ — Long-term portion of operating lease liabilities 8,366 — Total operating lease liabilities $ 9,405 $ — |
Schedule of the components of lease cost | The components of lease costs, which were included in operating expenses in its condensed consolidated statements of operations, were as follows (in thousands): Three Months Ended 2019 2018 Operating lease cost $ 458 $ — Variable lease cost 28 — Total lease cost $ 486 $ — |
Schedule of the maturities of operating lease liabilities | As of March 31, 2019 , the maturities of operating lease liabilities were as follows (in thousands): Operating leases (1) 2019 (remaining) $ 1,504 2020 2,057 2021 2,086 2022 2,118 2023 2,181 Thereafter 3,011 Total lease payments 12,957 Less: Imputed interest (3,552 ) Operating lease liabilities $ 9,405 (1) The table above does not include any legally binding minimum lease payments for leases signed but not yet commenced of approximately $1.6 million . |
Schedule of future minimum lease payments under the non-cancelable facility operating lease | As of December 31, 2018, future minimum lease payments under the non-cancelable facility operating lease, were as follows (in thousands): Amount 2019 $ 1,938 2020 1,996 2021 2,056 2022 2,118 2023 2,181 Thereafter 3,011 Total $ 13,300 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of payment obligations under the Royalty-Backed Loan | Payment obligations under the Royalty-Backed Loan are as follows (in thousands): March 31, 2019 December 31, 2018 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (74,529 ) (78,261 ) Less: Payments made (4,283 ) (2,618 ) Carrying value of loans payable $ 121,188 $ 119,121 Less: Current portion of long-term debt (1,527 ) (1,664 ) Non-current portion of long-term debt $ 119,661 $ 117,457 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Schedule of shares of Company's common stock reserved for future issuance | Shares of the Company’s common stock reserved for future issuance are as follows: March 31, 2019 December 31, 2018 Common stock awards issued and outstanding 6,548,752 5,949,436 Authorized for future issuance under 2014 Equity Incentive Plan 2,340,730 1,814,179 Authorized for future issuance under 2016 Inducement Plan 848,326 512,440 Employee stock purchase plan 1,121,449 847,105 Total 10,859,257 9,123,160 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 and 2018 (in thousands): Three Months Ended 2019 2018 Research and development $ 590 $ 772 Selling, general and administrative 2,794 2,969 Total stock-based compensation expense $ 3,384 $ 3,741 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of outstanding shares of potentially dilutive securities excluded from the computation of diluted net loss per share of common stock, because including them would have been anti-dilutive | The following total outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented, because including them would have been anti-dilutive (in thousands): Three Months Ended 2019 2018 Options to purchase common stock 5,741 5,753 Restricted stock units 808 512 Total 6,549 6,265 |
Description of Business (Detail
Description of Business (Details) | 3 Months Ended |
Mar. 31, 2019segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Recently Adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use assets | $ 7,368 | $ 7,566 | $ 0 |
Other current liabilities | 1,452 | 1,280 | 512 |
Long-term portion of operating lease liabilities | 8,366 | 8,643 | 0 |
Other non-current liabilities | $ 1,453 | 1,352 | 3,196 |
Previously Reported | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use assets | 0 | ||
Other current liabilities | 512 | ||
Long-term portion of operating lease liabilities | 0 | ||
Other non-current liabilities | $ 3,196 | ||
Adjustment due to the Adoption of Topic 842 | Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use assets | 7,566 | ||
Other current liabilities | 768 | ||
Long-term portion of operating lease liabilities | 8,643 | ||
Other non-current liabilities | $ (1,844) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring basis - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Total assets measured at fair value | $ 145,119 | $ 172,054 |
Liabilities: | ||
Total liabilities measured at fair value | 1,453 | 1,352 |
Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 1,453 | 1,352 |
Level 1 | ||
Assets: | ||
Total assets measured at fair value | 13,420 | 17,789 |
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 | 131,699 | 154,265 |
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 | 1,453 | 1,352 |
Level 3 | Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 1,453 | 1,352 |
Money market | ||
Assets: | ||
Total assets measured at fair value | 13,420 | 17,789 |
Money market | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 13,420 | 17,789 |
Money market | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Money market | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Corporate debt | ||
Assets: | ||
Total assets measured at fair value | 22,911 | 19,792 |
Corporate debt | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Corporate debt | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 22,911 | 19,792 |
Corporate debt | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury notes | ||
Assets: | ||
Total assets measured at fair value | 105,807 | 131,512 |
U.S. Treasury notes | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury notes | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 105,807 | 131,512 |
U.S. Treasury notes | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Commercial paper | ||
Assets: | ||
Total assets measured at fair value | 2,981 | 2,961 |
Commercial paper | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Commercial paper | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 2,981 | 2,961 |
Commercial paper | Level 3 | ||
Assets: | ||
Total assets measured at fair value | $ 0 | $ 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, 2019USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance as of December 31, 2018 | $ 1,352 |
Change in fair value included in interest and other income, net | 101 |
Balance as of March 31, 2019 | $ 1,453 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Available-for-sale securities | ||
Amortized Cost | $ 131,733 | $ 154,529 |
Gross Unrealized Gains | 41 | 10 |
Gross Unrealized Losses | (75) | (274) |
Fair Value | 131,699 | 154,265 |
Short-term investments | ||
Available-for-sale securities | ||
Amortized Cost | 131,733 | 154,529 |
Gross Unrealized Gains | 41 | 10 |
Gross Unrealized Losses | (75) | (274) |
Fair Value | 131,699 | 154,265 |
Accrued interest | 600 | 500 |
Long-term investments | ||
Available-for-sale securities | ||
Amortized Cost | 0 | 0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 0 | 0 |
Long-term investments | Maximum | ||
Available-for-sale securities | ||
Maturity of long term investment | 12 months | |
Corporate debt | ||
Available-for-sale securities | ||
Amortized Cost | $ 22,909 | 19,833 |
Gross Unrealized Gains | 7 | 0 |
Gross Unrealized Losses | (5) | (41) |
Fair Value | 22,911 | 19,792 |
U.S. Treasury notes | ||
Available-for-sale securities | ||
Amortized Cost | 105,843 | 131,735 |
Gross Unrealized Gains | 34 | 10 |
Gross Unrealized Losses | (70) | (233) |
Fair Value | 105,807 | 131,512 |
Commercial paper | ||
Available-for-sale securities | ||
Amortized Cost | 2,981 | 2,961 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 2,981 | $ 2,961 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,293 | $ 1,330 |
Work-in-process | 2,411 | 2,174 |
Finished goods | 1,498 | 1,617 |
Total inventory | $ 5,202 | $ 5,121 |
License Agreements (Details)
License Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Nov. 30, 2012 | Mar. 31, 2019 | Mar. 31, 2018 | |
License Agreements | |||
Period describing the commercial launch of dose | 15 years | ||
License agreement | |||
License Agreements | |||
Upfront payment received | $ 65,000,000 | ||
Maximum total additional cash payments receivable upon achievement of certain development and regulatory milestones | $ 95,000,000 | ||
Prosecution and litigation cost | $ 0 | $ 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jun. 30, 2018USD ($) | Jan. 31, 2018USD ($)ft²option | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | |
Lessee, Lease, Description [Line Items] | ||||
Operating lease, cash payments to be required | $ 234 | $ 0 | ||
Weighted average remaining lease term | 6 years | |||
Weighted average discount rate | 11.10% | |||
Office facility | Emeryville, CA | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease, rentable square footage (in sqft) | ft² | 37,626 | |||
Operating lease, number of options to extend | option | 1 | |||
Operating lease, option to extend, term | 5 years | |||
Operating lease, tenet improvement allowance | $ 1,100 | |||
Office equipment | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease, term | 3 years | |||
Operating lease, cash payments to be required | $ 200 | |||
Vehicles | ||||
Lessee, Lease, Description [Line Items] | ||||
Lessee, operating lease, lease not yet commenced, term | 12 months | |||
Vehicles | Master Vehicle Lease | ||||
Lessee, Lease, Description [Line Items] | ||||
Lessee, operating lease, lease not yet commenced, term | 3 years |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
Operating lease right-of-use assets | $ 7,368 | $ 7,566 | $ 0 |
Current portion included in other current liabilities | 1,039 | 0 | |
Long-term portion of operating lease liabilities | 8,366 | $ 8,643 | 0 |
Total operating lease liabilities | $ 9,405 | $ 0 |
Leases - Components of Lease Co
Leases - Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Leases [Abstract] | ||
Operating lease cost | $ 458 | $ 0 |
Variable lease cost | 28 | 0 |
Total lease cost | $ 486 | $ 0 |
Leases - Maturities of Operatin
Leases - Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
2019 (remaining) | $ 1,504 | |
2020 | 2,057 | |
2021 | 2,086 | |
2022 | 2,118 | |
2023 | 2,181 | |
Thereafter | 3,011 | |
Total lease payments | 12,957 | |
Less: Imputed interest | (3,552) | |
Operating lease liabilities | 9,405 | $ 0 |
Lessee, operating lease, lease not yet commenced, liability | $ 1,600 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 1,938 |
2020 | 1,996 |
2021 | 2,056 |
2022 | 2,118 |
2023 | 2,181 |
Thereafter | 3,011 |
Total | $ 13,300 |
Commitments and Contingencies -
Commitments and Contingencies - Indemnification (Details) | Mar. 31, 2019claim |
Commitments and Contingencies Disclosure [Abstract] | |
Number of indemnification claims | 0 |
Commitments and Contingencies_2
Commitments and Contingencies - Litigation and Other Legal Proceedings (Details) $ in Billions | Mar. 31, 2019USD ($)claim |
Loss Contingencies [Line Items] | |
Number of legal claims | claim | 0 |
Qui Tam Complaint | Pending Litigation | Unfavorable Regulatory Action | |
Loss Contingencies [Line Items] | |
Claim for damages (potentially more than) | $ | $ 2.5 |
Long-term Debt (Details)
Long-term Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
May 31, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | |
Level 3 | ||||
Debt Instrument [Line Items] | ||||
Long-term debt, fair value | $ 100,600,000 | |||
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% | |||
Unpaid interest payment added to principal amount, term | 2 years 3 months | |||
Contingent consideration, asset | $ 65,000,000 | |||
Lender expense | $ 400,000 | |||
Payment of debt issuance costs | $ 800,000 | |||
Interest expense | $ 3,700,000 | $ 4,800,000 | ||
Effective interest rate | 14.30% | |||
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, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Less: Current portion of long-term debt | $ (1,527) | $ (1,664) |
Long-term debt | 119,661 | 117,457 |
HCRP | Royalty-backed loan agreement | ||
Debt Instrument [Line Items] | ||
Total repayment obligation | 200,000 | 200,000 |
Less: Interest to be accreted in future periods | (74,529) | (78,261) |
Less: Payments made | (4,283) | (2,618) |
Carrying value of loans payable | 121,188 | 119,121 |
Less: Current portion of long-term debt | (1,527) | (1,664) |
Long-term debt | $ 119,661 | $ 117,457 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 1 Months Ended | 3 Months Ended | |||||
Jan. 31, 2018USD ($)$ / sharesshares | Mar. 31, 2019USD ($)voteshares | Mar. 31, 2018USD ($)shares | Dec. 31, 2018shares | 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 | $ | $ 0 | $ 134,433,000 | |||||
Total common stock reserved for future issuance (in shares) | 10,859,257 | 9,123,160 | |||||
2016 Inducement Plan | |||||||
Shareholders' Equity | |||||||
Total common stock reserved for future issuance (in shares) | 1,800,000 | 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) | 1,121,449 | 847,105 | |||||
Stock options | |||||||
Shareholders' Equity | |||||||
Total common stock reserved for future issuance (in shares) | 6,548,752 | 5,949,436 | |||||
Stock options | 2014 Equity Incentive Plan | |||||||
Shareholders' Equity | |||||||
Authorized for future issuance (in shares) | 2,340,730 | 1,814,179 | |||||
Stock options | 2016 Inducement Plan | |||||||
Shareholders' Equity | |||||||
Authorized for future issuance (in shares) | 848,326 | 512,440 | |||||
Common Stock | |||||||
Shareholders' Equity | |||||||
Sale of shares under the sales agreement (in shares) | 3,450,000 | 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 ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 11 Months Ended | ||||||
Mar. 31, 2019 | Jan. 31, 2018 | Nov. 30, 2017 | Jan. 31, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Nov. 30, 2017 | Dec. 31, 2018 | Mar. 31, 2016 | |
Stock Option Plans | |||||||||
Company’s common stock available for issuance (in shares) | 10,859,257 | 10,859,257 | 9,123,160 | ||||||
Stock-based compensation capitalized in inventory | $ 26 | $ 49 | |||||||
Employee Stock Purchase 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 | 1.00% | ||||||||
Increase in common stock available for issuance (in shares) | 274,344 | ||||||||
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) | 1,097,374 | ||||||||
2016 Inducement Plan | |||||||||
Stock Option Plans | |||||||||
Company’s common stock available for issuance (in shares) | 1,800,000 | 1,800,000 | 450,000 | ||||||
Company’s additional common stock available for issuance (in shares) | 450,000 | 450,000 | 450,000 | 1,350,000 |
Stock-Based Compensation - Inco
Stock-Based Compensation - Income Statement Location (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stock-based compensation expense | ||
Total stock-based compensation expense | $ 3,384 | $ 3,741 |
Research and development | ||
Stock-based compensation expense | ||
Total stock-based compensation expense | 590 | 772 |
Selling, general and administrative | ||
Stock-based compensation expense | ||
Total stock-based compensation expense | $ 2,794 | $ 2,969 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities (in shares) | 6,549 | 6,265 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities (in shares) | 5,741 | 5,753 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities (in shares) | 808 | 512 |