Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-36399 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 42-1560076 | |
Entity Address, Address Line One | 1900 Powell Street | |
Entity Address, Address Line Two | Suite 1000 | |
Entity Address, City or Town | Emeryville | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94608 | |
City Area Code | 510 | |
Local Phone Number | 450-3500 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | ADMS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 28,281,840 | |
Entity Registrant Name | Adamas Pharmaceuticals Inc | |
Entity Central Index Key | 0001328143 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 30,538 | $ 65,774 |
Available-for-sale securities | 72,876 | 66,833 |
Accounts receivable, net | 6,608 | 5,770 |
Inventory | 5,851 | 5,267 |
Prepaid expenses and other current assets | 7,814 | 6,676 |
Total current assets | 123,687 | 150,320 |
Property and equipment, net | 1,989 | 2,449 |
Operating lease right-of-use assets | 7,351 | 8,048 |
Prepaid expenses and other non-current assets | 38 | 1,341 |
Total assets | 133,065 | 162,158 |
Current liabilities | ||
Accounts payable | 2,469 | 6,932 |
Accrued liabilities | 13,694 | 16,117 |
Current portion of long-term debt | 3,232 | 2,041 |
Other current liabilities | 1,820 | 1,858 |
Total current liabilities | 21,215 | 26,948 |
Long-term debt | 126,300 | 125,674 |
Long-term portion of operating lease liabilities | 7,364 | 8,272 |
Other non-current liabilities | 2,595 | 2,157 |
Total liabilities | 157,474 | 163,051 |
Commitments and Contingencies (Note 7) | ||
Stockholders’ deficit | ||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at June 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value — 100,000,000 shares authorized, 28,281,840 and 27,964,778 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 33 | 33 |
Additional paid-in capital | 450,536 | 446,942 |
Accumulated other comprehensive gain | 120 | 16 |
Accumulated deficit | (475,098) | (447,884) |
Total stockholders’ deficit | (24,409) | (893) |
Total liabilities and stockholders’ deficit | $ 133,065 | $ 162,158 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
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) | 28,281,840 | 27,964,778 |
Common stock, outstanding (in shares) | 28,281,840 | 27,964,778 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Total revenues | $ 18,794,000 | $ 12,691,000 | $ 33,275,000 | $ 24,356,000 |
Costs and operating expenses: | ||||
Cost of product sales | 381,000 | 685,000 | 953,000 | 1,098,000 |
Research and development | 2,550,000 | 8,598,000 | 5,015,000 | 18,812,000 |
Selling, general and administrative, net | 23,177,000 | 25,216,000 | 47,729,000 | 52,904,000 |
Total costs and operating expenses | 26,108,000 | 34,499,000 | 53,697,000 | 72,814,000 |
Loss from operations | (7,314,000) | (21,808,000) | (20,422,000) | (48,458,000) |
Interest and other income, net | 215,000 | 734,000 | 299,000 | 1,457,000 |
Interest expense | (3,467,000) | (3,797,000) | (7,091,000) | (7,528,000) |
Net loss | $ (10,566,000) | $ (24,871,000) | $ (27,214,000) | $ (54,529,000) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.37) | $ (0.90) | $ (0.97) | $ (1.98) |
Weighted average shares used in computing net loss per share, basic and diluted (in shares) | 28,194 | 27,579 | 28,112 | 27,516 |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Product sales | ||||
Revenues: | ||||
Total revenues | $ 17,954,000 | $ 12,691,000 | $ 32,435,000 | $ 24,356,000 |
Royalty revenue | ||||
Revenues: | ||||
Total revenues | $ 840,000 | $ 0 | $ 840,000 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (10,566) | $ (24,871) | $ (27,214) | $ (54,529) |
Other comprehensive income | ||||
Reclassification of realized gain on available-for-sale securities recognized in interest and other income, net | (34) | 0 | (34) | 0 |
Unrealized gain on available-for-sale securities | 81 | 137 | 138 | 367 |
Total other comprehensive income | 47 | 137 | 104 | 367 |
Comprehensive loss | $ (10,519) | $ (24,734) | $ (27,110) | $ (54,162) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
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 | 49 | |||
Restricted stock units vested (in shares) | 67,391 | ||||
Other comprehensive income | 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) |
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 | |||||
Other comprehensive income | 367 | ||||
Net loss | (54,529) | ||||
Ending balance (in shares) at Jun. 30, 2019 | 27,710,207 | ||||
Ending balance at Jun. 30, 2019 | 42,703 | $ 32 | 439,795 | 103 | (397,227) |
Beginning balance (in shares) at Mar. 31, 2019 | 27,519,979 | ||||
Beginning balance at Mar. 31, 2019 | 63,916 | $ 32 | 436,274 | (34) | (372,356) |
Increase (decrease) in shareholders' equity | |||||
Exercise of stock options (in shares) | 65,064 | ||||
Exercise of stock options | 99 | 99 | |||
Restricted stock units vested (in shares) | 12,860 | ||||
Stock issued under employee stock purchase plan (in shares) | 112,304 | ||||
Stock issued under employee stock purchase plan | 449 | 449 | |||
Other comprehensive income | 137 | 137 | |||
Stock-based compensation | 2,973 | 2,973 | |||
Net loss | (24,871) | (24,871) | |||
Ending balance (in shares) at Jun. 30, 2019 | 27,710,207 | ||||
Ending balance at Jun. 30, 2019 | 42,703 | $ 32 | 439,795 | 103 | (397,227) |
Beginning balance (in shares) at Dec. 31, 2019 | 27,964,778 | ||||
Beginning balance at Dec. 31, 2019 | (893) | $ 33 | 446,942 | 16 | (447,884) |
Increase (decrease) in shareholders' equity | |||||
Exercise of stock options (in shares) | 61,766 | ||||
Exercise of stock options | 42 | 42 | |||
Restricted stock units vested (in shares) | 131,661 | ||||
Other comprehensive income | 57 | 57 | |||
Stock-based compensation | 1,589 | 1,589 | |||
Net loss | (16,648) | (16,648) | |||
Ending balance (in shares) at Mar. 31, 2020 | 28,158,205 | ||||
Ending balance at Mar. 31, 2020 | (15,853) | $ 33 | 448,573 | 73 | (464,532) |
Beginning balance (in shares) at Dec. 31, 2019 | 27,964,778 | ||||
Beginning balance at Dec. 31, 2019 | (893) | $ 33 | 446,942 | 16 | (447,884) |
Increase (decrease) in shareholders' equity | |||||
Other comprehensive income | 104 | ||||
Net loss | (27,214) | ||||
Ending balance (in shares) at Jun. 30, 2020 | 28,281,840 | ||||
Ending balance at Jun. 30, 2020 | (24,409) | $ 33 | 450,536 | 120 | (475,098) |
Beginning balance (in shares) at Mar. 31, 2020 | 28,158,205 | ||||
Beginning balance at Mar. 31, 2020 | (15,853) | $ 33 | 448,573 | 73 | (464,532) |
Increase (decrease) in shareholders' equity | |||||
Restricted stock units vested (in shares) | 28,541 | ||||
Stock issued under employee stock purchase plan (in shares) | 95,094 | ||||
Stock issued under employee stock purchase plan | 223 | 223 | |||
Other comprehensive income | 47 | 47 | |||
Stock-based compensation | 1,740 | 1,740 | |||
Net loss | (10,566) | (10,566) | |||
Ending balance (in shares) at Jun. 30, 2020 | 28,281,840 | ||||
Ending balance at Jun. 30, 2020 | $ (24,409) | $ 33 | $ 450,536 | $ 120 | $ (475,098) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (27,214,000) | $ (54,529,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation | 460,000 | 692,000 |
Stock-based compensation | 3,176,000 | 6,323,000 |
Accretion of interest expense | 7,091,000 | 7,528,000 |
Change in fair value of embedded derivative liability | 438,000 | 149,000 |
Net accretion of discounts and amortization of premiums of available-for-sale securities | (147,000) | (675,000) |
Realized gain on available-for-sale securities | (55,000) | 0 |
Provision for write-down of inventory | 340,000 | 0 |
Changes in assets and liabilities | ||
Accrued interest of available-for-sale securities | 236,000 | 54,000 |
Accounts receivable, net | (838,000) | (900,000) |
Inventory | (666,000) | (524,000) |
Prepaid expenses and other assets | 165,000 | 619,000 |
Operating lease right-of-use assets | 697,000 | 413,000 |
Accounts payable | (4,436,000) | (253,000) |
Current portion of long-term debt | (5,274,000) | (3,121,000) |
Long-term portion of operating lease liabilities | (810,000) | (482,000) |
Accrued liabilities and other liabilities | (2,691,000) | 899,000 |
Net cash used in operating activities | (29,528,000) | (43,807,000) |
Cash flows from investing activities | ||
Purchases of property and equipment | (18,000) | |
Purchases of available-for-sale securities | (63,939,000) | (38,657,000) |
Maturities of available-for-sale securities | 40,900,000 | 88,000,000 |
Sales of available-for-sale securities | 17,066,000 | 0 |
Net cash provided by (used in) investing activities | (5,973,000) | 49,325,000 |
Cash flows from financing activities | ||
Proceeds from Paycheck Protection Program Loan | 2,650,000 | 0 |
Repayment of Paycheck Protection Program Loan | (2,650,000) | 0 |
Proceeds from issuance of common stock upon exercise of stock options | 42,000 | 165,000 |
Proceeds from employee stock purchase plan | 223,000 | 449,000 |
Net cash provided by financing activities | 265,000 | 614,000 |
Net increase (decrease) in cash and cash equivalents | (35,236,000) | 6,132,000 |
Cash and cash equivalents at beginning of period | 65,774,000 | 56,605,000 |
Cash and cash equivalents at end of period | 30,538,000 | 62,737,000 |
Supplemental disclosure of noncash activities | ||
Right-of-use assets obtained in exchange for operating lease liabilities | 0 | 8,005,000 |
Stock-based compensation capitalized in inventory | $ 153,000 | $ 60,000 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS Adamas Pharmaceuticals, Inc. (the “Company”) is a commercial-stage pharmaceutical company focused on supporting its patient community and growing a portfolio of therapies to reduce the burden of neurological diseases on patients, caregivers, and society. In August 2017, the U.S. Food and Drug Administration (FDA) approved GOCOVRI ® (amantadine) extended release capsules, the first and only FDA-approved medication indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company was incorporated in the State of Delaware on November 15, 2000, and operates as one segment. The Company’s headquarters and operations are located in Emeryville, California. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
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, these financial statements include all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the Company’s condensed consolidated financial statements for the periods presented. The condensed consolidated balance sheet at December 31, 2019 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, 2020, 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, 2019, 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, 2019. The Company’s critical accounting policies have not changed materially from December 31, 2019. 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. Risks and Uncertainties The outbreak of the novel Coronavirus (“COVID-19”), which is understood to have begun in December 2019, continues to grow both within the U.S. and globally. The World Health Organization has declared the outbreak of COVID-19 to be a pandemic, and the U.S. federal government has declared it a national emergency. The Company is subject to risks and uncertainties as a result of the outbreak of COVID-19. Despite disruptions to the Company’s business operations, the COVID-19 pandemic did not significantly impact GOCOVRI prescription refill rates for the three and six months ended June 30, 2020, and thus far management has observed no disruptions to its inventory on hand or planned manufacturing schedule. However, new prescription rates have slowed due to several factors, including: many healthcare providers have temporarily closed their offices or are restricting patient visits; patients are postponing visits to healthcare provider facilities; and the sales force has moved to conducting activities virtually with healthcare providers. While management believes this decline in new prescriptions to be temporary, the duration and severity is dependent on future developments, including new information that may emerge concerning the actions taken to contain or prevent further spread, all of which are highly uncertain and cannot be predicted with confidence. As of the date of issuance of these condensed consolidated financial statements, due to the numerous uncertainties surrounding the COVID-19 pandemic, the Company is unable to predict the extent to which the COVID-19 pandemic may materially adversely affect the Company’s future business, financial results, liquidity and cash flows. Liquidity Since January 1, 2017, the Company has funded its operations primarily through a royalty-backed loan agreement (“Royalty-Backed Loan”) with HealthCare Royalty Partners III, L.P., (“HCRP”), sales of GOCOVRI, and sales of its common stock. In 2017, the Company entered into a Royalty-Backed Loan with HCRP, whereby the Company borrowed a total of $100.0 million. The Company made GOCOVRI available for physician and patient use in the fourth quarter of 2017, with a full commercial launch in January 2018. In January 2018, the Company completed a follow-on public offering of its common stock from which proceeds raised were approximately $134.3 million, net of underwriting discounts, commissions, and offering-related transaction costs. Prior to the generation of revenue from GOCOVRI, the Company had not generated any commercial revenue from the sale of its products. In November 2019, the Company entered into a sales agreement with Cowen and Company, LLC, pursuant to which it may, from time to time, issue and sell shares of common stock having an aggregate offering value of up to $50.0 million. As of June 30, 2020, no shares had been sold under the sales agreement. As of June 30, 2020, the Company had $103.4 million of cash, cash equivalents, and investments, which management believes will be sufficient to fund its projected operating requirements, including commercialization of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease and operations related to activities for ADS-5102 for MSW, for at least 12 months from the issuance of this quarterly report on Form 10-Q. However, it is possible that the Company will not achieve the progress it expects, because revenues from GOCOVRI may be less than anticipated, especially in light of the current COVID-19 pandemic. Recent Accounting Pronouncements Accounting Pronouncements Adopted in 2020 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. The Company adopted the new guidance effective January 1, 2020, and determined the adoption did not have a material impact on its consolidated financial statements. Disclosures are updated in Note 3 “Fair Value Measurements”. 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. The Company adopted the new guidance effective January 1, 2020, and determined the adoption did not have a material impact on its consolidated financial statements. New Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses ; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments ; in May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief ; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses . The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842)—Effective Dates , which defers the effective date of ASU 2016-13 for all entities except SEC reporting companies that are not smaller reporting companies. As a smaller reporting company, this guidance is effective for fiscal years beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the timing and effect the new guidance will have on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes , which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
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): June 30, 2020 Total Level 1 Level 2 Level 3 Assets: Money market $ 10,954 $ 10,954 $ — $ — Corporate debt 13,792 — 13,792 — U.S. Treasury securities 59,084 — 59,084 — Commercial paper — — — — Total assets measured at fair value $ 83,830 $ 10,954 $ 72,876 $ — Liabilities: Embedded derivative liability $ 2,595 $ — $ — $ 2,595 Total liabilities measured at fair value $ 2,595 $ — $ — $ 2,595 December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market $ 27,720 $ 27,720 $ — $ — Corporate debt 22,576 — 22,576 — U.S. Treasury securities 37,811 — 37,811 — Commercial paper 10,928 — 10,928 — Total assets measured at fair value $ 99,035 $ 27,720 $ 71,315 $ — Liabilities: Embedded derivative liability $ 2,157 $ — $ — $ 2,157 Total liabilities measured at fair value $ 2,157 $ — $ — $ 2,157 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. Corporate debt, U.S. Treasury securities, and commercial paper are measured at fair value using Level 2 inputs. The Company reviews trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. In certain cases where there is limited activity or less transparency around inputs to valuation, the related assets or liabilities are classified as Level 3. The Company classified an embedded derivative related to the Company’s Royalty-Backed Loan with HCRP as a Level 3 liability. The fair value of the embedded derivative as a result of a change in control was calculated using a probability-weighted discounted cash flow model. The model used in valuing this embedded derivative requires the use of significant estimates and assumptions including but not limited to: 1) expected cash flows the Company expects to receive on U.S. net sales of GOCOVRI and on royalties from Allergan on U.S. net sales of Namzaric; 2) the Company’s risk adjusted discount rates; and 3) the probability of a change in control occurring during the term of the note based on the percentage of similar companies that were acquired over the previous five year period. Changes in the estimated fair value of the bifurcated embedded derivative are reported as gains or losses in interest and other income, net, in the 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. At June 30, 2020, the embedded derivative related to the Royalty-Backed Loan was the only recurring fair value measurement with Level 3 unobservable inputs. A risk-adjusted discount rate of 19.6% and a probability of a change in control of 3.0% were applied to calculate the value of the embedded derivative. Significant increases (or decreases) in the discount rate, and significant increases (or decreases) in the probability of a change in control would result in a significantly higher (or lower) fair value measurement. The following table sets forth changes in Level 3 liabilities measured at fair value on a recurring basis for the three and six months ended June 30, 2020 and 2019 (in thousands): Three Months Ended Six Months Ended 2020 2019 2020 2019 Beginning balance $ 2,498 $ 1,453 $ 2,157 $ 1,352 Change in fair value included in interest and other income, net 97 48 438 149 Ending balance $ 2,595 $ 1,501 $ 2,595 $ 1,501 |
Investments
Investments | 6 Months Ended |
Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | INVESTMENTS The Company’s investments consist of corporate debt, U.S. Treasury securities, and commercial paper classified as available-for-sale securities. The Company limits the amount of investment exposure as to institution, maturity, and investment type. To mitigate credit risk, the Company invests in investment grade corporate debt, U.S. Treasury securities, and commercial paper. Such securities are reported at fair value, with unrealized gains and losses excluded from earnings and shown separately as a component of accumulated other comprehensive loss within stockholders’ equity. Realized gains and losses are reclassified from other comprehensive loss to other income on the 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 June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Investments: Corporate debt $ 13,718 $ 74 $ — $ 13,792 U.S. Treasury securities 59,038 47 (1) 59,084 Commercial paper — Total $ 72,756 $ 121 $ (1) $ 72,876 Reported as: Short-term investments $ 72,756 $ 121 $ (1) $ 72,876 Total $ 72,756 $ 121 $ (1) $ 72,876 December 31, 2019 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Investments: Corporate debt $ 22,582 $ 3 $ (9) $ 22,576 U.S. Treasury securities 37,789 22 — 37,811 Commercial paper 6,446 — — 6,446 Total $ 66,817 $ 25 $ (9) $ 66,833 Reported as: Short-term investments $ 66,817 $ 25 $ (9) $ 66,833 Total $ 66,817 $ 25 $ (9) $ 66,833 Short-term investments include accrued interest of $0.2 million and $0.4 million as of June 30, 2020 and December 31, 2019, respectively. For both the three and six months ended June 30, 2020, there were gross realized gains on investments of $55,000 and no gross realized losses. There were no gross realized gains or losses on investments for the three and six months ended June 30, 2019. Realized gains are reflected in interest and other income, net, in the condensed consolidated statements of operations, using the specific-identification method. 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 June 30, 2020 and December 31, 2019. All investments with unrealized losses at June 30, 2020 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 | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY If the Company identifies excess, obsolete or unsalable product, the Company will write down its inventory to net realizable value in the period it is identified. During the six months ended June 30, 2020, the Company recorded a $0.3 million provision for the write-down of inventory to cost of sales. There was no write-down of inventory during the six months ended June 30, 2019. Inventory consists of the following (in thousands): June 30, 2020 December 31, 2019 Raw materials $ 804 $ 1,057 Work-in-process 3,229 1,925 Finished goods 1,818 2,285 Total inventory $ 5,851 $ 5,267 |
License Agreements
License Agreements | 6 Months Ended |
Jun. 30, 2020 | |
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 and six months ended June 30, 2020 and 2019, there were no reimbursable external costs for prosecution or litigation of intellectual property rights. In addition, the Company may earn tiered royalty payments based on net sales of Namzaric and Namenda XR. Beginning in May 2020, the Company became entitled to receive royalties at rates in the low double digits to mid-teens from Allergan for sales of Namzaric in the United States. The Company recognized $0.8 million in Namzaric royalty revenue for both the three and six months ended June 30, 2020, and recognized no royalty revenue for the three and six months ended June 30, 2019. Accrued revenue related to Namzaric royalties is recorded in prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets. 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, but is eliminated in any quarter where there is significant competition from generics. Based on Allergan’s and the Company’s current settlement agreements with the Namzaric ANDA filers to date, the earliest date on which any of these agreements grant a license to market a Namzaric ANDA filer’s generic version of Namzaric is January 1, 2025 (or earlier in certain circumstances). Alternatively, the Namzaric ANDA filers with the earliest license date have the option to launch an authorized generic version of Namzaric beginning on January 1, 2026 instead of launching their own generic version of Namzaric on January 1, 2025. For further discussion of Namzaric ANDA filers, see Litigation and Other Legal Proceedings |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Purchase Commitments The Company has entered into agreements for the supply of API and the manufacture of commercial supply of GOCOVRI, with Moehs Ibérica, S.L. and Catalent Pharma Solutions, LLC, respectively. Under the terms of the agreements, the Company will supply the vendors with non-cancelable firm commitment purchase orders. The Company has also entered into other agreements with certain vendors for the provision of services, including services related to data access and packaging, under which the Company is contractually obligated to make certain payments to the vendors. The Company enters into contracts in the normal course of business that include, among others, arrangements with CROs for clinical trials, vendors for preclinical research, and vendors for manufacturing. These contracts generally provide for termination upon notice, and therefore the Company believes that its obligations under these agreements are not material. Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. Indemnification In accordance with the Company’s amended and restated certificate of incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. The Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for claims. In addition, in the normal course of business, the Company enters into contracts and agreements that may contain a variety of representations and warranties and provide for general indemnifications. For example, the Company provided certain indemnifications to its agents and underwriters as part of the Company’s January 2018 underwritten secondary public offering of common stock. Underwriters have now made a claim to such indemnifications in conjunction with the ongoing litigation involving that transaction. Litigation and Other Legal Proceedings In November 2012, the Company granted Forest an exclusive license to certain of the Company’s intellectual property rights relating to human therapeutics containing memantine in the United States. Under the terms of that license agreement, Forest has the right to enforce such intellectual property rights which are related to its right to market and sell Namzaric and Namenda XR for the treatment of moderate to severe dementia related to Alzheimer’s disease. The Company has a right to participate in, but not control, such enforcement actions by Forest. In 2018 and as of the date of this filing, multiple generic companies have launched generic versions of Namenda XR. As of the date of this filing, a number of companies have submitted ANDAs including one or more certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(iv) to the FDA requesting approval to manufacture and market generic versions of Namzaric, on which the Company is entitled to receive royalties from Forest beginning in May 2020. As of the date of this filing, the Company and Forest have settled with all such Namzaric ANDA filers, including all first filers on all the available dosage forms of Namzaric. Subject to those agreements, the earliest date on which any of these agreements grant a license to market a Namzaric ANDA filer’s generic version of Namzaric is January 1, 2025 (or earlier in certain circumstances). Alternatively, the Namzaric ANDA filers with the earliest date have the option to launch an authorized generic version of Namzaric beginning on January 1, 2026 instead of launching their own generic version of Namzaric on January 1, 2025. The Company and Forest intend to continue to enforce the patents associated with Namzaric. On February 16, 2018, Osmotica Pharmaceuticals LLC and Vertical Pharmaceuticals LLC (“Osmotica”) filed an action against the Company in U.S. District Court for the state of Delaware, requesting a declaratory judgment that Osmotica’s newly-approved product Osmolex ER™ (amantadine) extended release tablets do not infringe certain of the Company’s patents. On September 20, 2018, the Company filed its first amended answer including infringement counterclaims against Osmotica asserting Osmotica has infringed nine Company patents under 35 U.S.C. §§ 271(a), (b), and/or (c) and 35 U.S.C. § 271(e)(2)(A) and seeking various forms of relief, including damages, treble damages, injunctive relief, and an order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of any approval of Osmotica’s NDA for Osmolex ER™ be a date that is not earlier than the latest expiration date of the Company patents involved in the lawsuit. This action is ongoing, but was stayed on May 23, 2019 at the parties’ joint request. On July 1, 2020, the Company received a letter dated June 29, 2020, notifying the Company that Zydus Worldwide DMCC (“Zydus”) submitted to the FDA an ANDA for Amantadine Extended-Release Capsules, 68.5 mg and 137 mg that contains certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the Company’s 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; 9,877,933; and 10,154,971, that these patents are invalid or will not be infringed by the manufacture, use or sale of Zydus’s Amantadine Extended-Release Capsules, 68.5 mg and 137 mg. On April 1, 2019, the Company was served with a complaint filed in the United States District Court for the Northern District of California (Case No. 3:18-cv-03018-JCS) against the Company and several Allergan entities alleging violations of Federal and state false claims acts (“FCA”) in connection with the commercialization of Namenda XR and Namzaric by Allergan. The lawsuit is a qui tam complaint brought by a named individual, Zachary Silbersher, asserting rights of the Federal government and various state governments. The lawsuit was originally filed in May 2018 under seal, and the Company became aware of the lawsuit when it was served. The complaint alleges that patents held by Allergan and the Company covering Namenda XR and Namzaric were procured through fraud on the United States Patent and Trademark Office and that these patents were asserted against potential generic manufacturers of Namenda XR and Namzaric to prevent the generic manufacturers from entering the market, thereby wrongfully excluding generic competition resulting in an artificially high price being charged to government payors. The Company’s patents in question were licensed exclusively to Forest. The complaint includes a claim for damages of “potentially more than $2.5 billion dollars,” treble damages “under the federal FCA and most of the State FCAs,” and “statutory penalties that can be assessed for each false claim.” This action is ongoing. The federal and state governments have declined to intervene in this action. To the Company’s knowledge, the individual plaintiff is pursuing the lawsuit in his individual capacity. The Company believes it has strong factual and legal defenses and intends to defend itself vigorously. The Company is in the early stages of this litigation. On May 13, 2019, a putative class action lawsuit alleging violations of the federal securities laws was filed in California Superior Court for the County of Alameda (Case No. RG1901875). The lawsuit alleges violations of the Securities Act of 1933 by the Company and certain of the Company’s current and former directors and officers for allegedly making false statements and omissions in the registration statement and prospectus filed by the Company in connection with our January 24, 2018, secondary public offering of common stock. On December 10, 2019, another putative class action lawsuit alleging violations of the federal securities laws was filed in federal court in the Northern District of California (Case No. 4:19-cv-08051). This lawsuit alleges violations of the Securities Act of 1934 by the Company and certain of the Company’s current and former officers. On March 16, 2020, a shareholder derivative lawsuit was filed in federal court in the Northern District of California (Case No. 4:20-cv-01815). This lawsuit alleges breaches of fiduciary duty and violations of the Securities Act of 1934 by certain of the Company’s current and former directors and officers. The Company is named as a nominal defendant only. On April 6, 2020, another, virtually identical, shareholder derivative lawsuit was filed in federal court in the Northern District of California (Case No. 4:20-cv-02320). This lawsuit contains the same allegations, claims, and defendants as the first derivative action. Other similar cases may be filed in the future. In all of these actions, Plaintiffs seek unspecified monetary damages and other relief. These actions are ongoing. The Company believes it has strong factual and legal defenses to all actions and intends to defend itself vigorously. From time to time, the Company may be party to legal proceedings, investigations, and claims in the ordinary course of its business. Other than the matters described above, the Company is not currently party to any material legal proceedings. |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Long-term Debt | LONG-TERM DEBT Royalty-Backed Loan Agreement In May 2017, the Company, through a new wholly-owned subsidiary, Adamas Pharma, LLC, entered into a Royalty-Backed Loan with HCRP, whereby the Company initially borrowed $35 million, followed by an additional $65 million received in the fourth quarter 2017 upon FDA’s recognition in the Orange Book of seven-year orphan drug exclusivity, which GOCOVRI earned upon approval on August 24, 2017. Principal and interest will be payable quarterly from the proceeds of a 12.5% royalty on U.S. net sales of GOCOVRI and up to $15 million of the Company’s annual royalties from Allergan on U.S. net sales of Namzaric starting in May 2020, pursuant to the Company’s license agreement with Allergan. The royalty rate on net sales of GOCOVRI will drop to 6.25% after the principal amount of the loan has been repaid in full, until the Company has made total payments of 200% of the funded amounts. The Company may elect to voluntarily prepay the loan at any time, or may be required to prepay subject to specified prepayment trigger events as described below, in which case the amount due will be 200% of the funded amounts, less total payments made to date. Royalty rates are subject to increase to 17.5% and 22.5% if total principal and interest payments have not reached minimum specified levels at measurement dates on December 2021 and December 2022, respectively. Under the terms of the loan, HCRP has recourse to Adamas Pharma, LLC, not the Company. The loan agreement matures in December 2026 but as the repayment of the loan amount is contingent upon the sales volumes of GOCOVRI and royalties from Allergan, the repayment term may be shortened depending on the actual sales of GOCOVRI and actual royalties received from Allergan. The loans bear interest at an annual rate of 11% on the outstanding principal amount and includes an interest-only period until the interest payment date following the ninth full calendar quarter after the $65 million additional loan received in the fourth quarter 2017. To the extent that royalties were insufficient to pay interest in full during the first nine quarters of the loan, any unpaid portion of the quarterly interest payment was added to the principal amount of the loans. This payment-in-kind period ended in the first quarter of 2020. 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 $3.5 million and $7.1 million for the three and six months ended June 30, 2020, respectively, and $3.8 million and $7.5 million for the three and six months ended June 30, 2019, 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 June 30, 2020 on the amounts borrowed under the Royalty-Backed Loan, including the amortization of the debt discount, was 13.0%. 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): June 30, 2020 December 31, 2019 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (56,126) (63,217) Less: Payments made (14,342) (9,068) Carrying value of loans payable $ 129,532 $ 127,715 Less: Current portion of long-term debt (3,232) (2,041) Non-current portion of long-term debt $ 126,300 $ 125,674 The estimated fair value of the long-term debt, as measured using Level 3 inputs, approximates $100.8 million as of June 30, 2020. 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 on U.S. net sales of Namzaric. Paycheck Protection Program |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2020 | |
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. Sales Agreement In November 2019, the Company entered into a sales agreement (“Sales Agreement”) with Cowen and Company, LLC (“Cowen”), as sales agent, pursuant to which the Company may, from time to time, issue and sell at its option, shares of the Company’s common stock for an aggregate offering price of up to $50.0 million under an at-the-market offering (“ATM Offering”). Sales of the common stock, if any, will be made pursuant to a shelf registration statement that was declared effective by the Securities and Exchange Commission (“SEC”) on December 2, 2019. Cowen is acting as sole sales agent for any sales made under the Sales Agreement and the Company will pay Cowen a commission of up to 3% of the gross proceeds. The Company’s common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices may vary. The Company is not obligated to make any sales of shares of common stock under the Sales Agreement. Unless otherwise terminated earlier, the Sales Agreement continues until all shares available under the Sales Agreement have been sold. As of June 30, 2020, 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: June 30, 2020 December 31, 2019 Common stock awards issued and outstanding 7,076,844 6,874,633 Authorized for future issuance under 2014 Equity Incentive Plan 3,262,732 2,376,613 Authorized for future issuance under 2016 Inducement Plan 494,562 236,269 Employee stock purchase plan 1,111,497 926,943 Total 11,945,635 10,414,458 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Stock Compensation Plans In January 2020, 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, 2019, or 1,118,591 shares. In February 2020, the Company’s board of directors approved an amendment to the 2016 Inducement Plan (the “Inducement Plan”) to increase the number of shares available for issuance by an additional 450,000. Employee Stock Purchase Plan In January 2020, 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, 2019, or 279,648 shares. Stock-Based Compensation Expense The following table reflects stock-based compensation expense recognized for the three and six months ended June 30, 2020 and 2019 (in thousands): Three Months Ended Six Months Ended 2020 2019 2020 2019 Research and development $ 134 $ 563 $ 220 $ 1,153 Selling, general and administrative 1,561 2,376 2,956 5,170 Total stock-based compensation expense $ 1,695 $ 2,939 $ 3,176 $ 6,323 Stock-based compensation of $45,000 and $153,000 was capitalized into inventory for the three and six months ended June 30, 2020, respectively, and $34,000 and $60,000 for the three and six months ended June 30, 2019, 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 | 6 Months Ended |
Jun. 30, 2020 | |
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 and Six Months Ended 2020 2019 Options to purchase common stock 5,450 5,716 Restricted stock units 1,627 900 Total 7,077 6,616 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
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, these financial statements include all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the Company’s condensed consolidated financial statements for the periods presented. The condensed consolidated balance sheet at December 31, 2019 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, 2020, 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, 2019, 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, 2019. The Company’s critical accounting policies have not changed materially from December 31, 2019. |
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. |
Risks and Uncertainties | Risks and Uncertainties The outbreak of the novel Coronavirus (“COVID-19”), which is understood to have begun in December 2019, continues to grow both within the U.S. and globally. The World Health Organization has declared the outbreak of COVID-19 to be a pandemic, and the U.S. federal government has declared it a national emergency. The Company is subject to risks and uncertainties as a result of the outbreak of COVID-19. Despite disruptions to the Company’s business operations, the COVID-19 pandemic did not significantly impact GOCOVRI prescription refill rates for the three and six months ended June 30, 2020, and thus far management has observed no disruptions to its inventory on hand |
Liquidity | Liquidity Since January 1, 2017, the Company has funded its operations primarily through a royalty-backed loan agreement (“Royalty-Backed Loan”) with HealthCare Royalty Partners III, L.P., (“HCRP”), sales of GOCOVRI, and sales of its common stock. In 2017, the Company entered into a Royalty-Backed Loan with HCRP, whereby the Company borrowed a total of $100.0 million. The Company made GOCOVRI available for physician and patient use in the fourth quarter of 2017, with a full commercial launch in January 2018. In January 2018, the Company completed a follow-on public offering of its common stock from which proceeds raised were approximately $134.3 million, net of underwriting discounts, commissions, and offering-related transaction costs. Prior to the generation of revenue from GOCOVRI, the Company had not generated any commercial revenue from the sale of its products. In November 2019, the Company entered into a sales agreement with Cowen and Company, LLC, pursuant to which it may, from time to time, issue and sell shares of common stock having an aggregate offering value of up to $50.0 million. As of June 30, 2020, no shares had been sold under the sales agreement. As of June 30, 2020, the Company had $103.4 million of cash, cash equivalents, and investments, which management believes will be sufficient to fund its projected operating requirements, including commercialization of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease and operations related to activities for ADS-5102 for MSW, for at least 12 months from the issuance of this quarterly report on Form 10-Q. However, it is possible that the Company will not achieve the progress it expects, because revenues from GOCOVRI may be less than anticipated, especially in light of the current COVID-19 pandemic. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Pronouncements Adopted in 2020 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. The Company adopted the new guidance effective January 1, 2020, and determined the adoption did not have a material impact on its consolidated financial statements. Disclosures are updated in Note 3 “Fair Value Measurements”. 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. The Company adopted the new guidance effective January 1, 2020, and determined the adoption did not have a material impact on its consolidated financial statements. New Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses ; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments ; in May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief ; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses . The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842)—Effective Dates , which defers the effective date of ASU 2016-13 for all entities except SEC reporting companies that are not smaller reporting companies. As a smaller reporting company, this guidance is effective for fiscal years beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the timing and effect the new guidance will have on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes , which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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): June 30, 2020 Total Level 1 Level 2 Level 3 Assets: Money market $ 10,954 $ 10,954 $ — $ — Corporate debt 13,792 — 13,792 — U.S. Treasury securities 59,084 — 59,084 — Commercial paper — — — — Total assets measured at fair value $ 83,830 $ 10,954 $ 72,876 $ — Liabilities: Embedded derivative liability $ 2,595 $ — $ — $ 2,595 Total liabilities measured at fair value $ 2,595 $ — $ — $ 2,595 December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market $ 27,720 $ 27,720 $ — $ — Corporate debt 22,576 — 22,576 — U.S. Treasury securities 37,811 — 37,811 — Commercial paper 10,928 — 10,928 — Total assets measured at fair value $ 99,035 $ 27,720 $ 71,315 $ — Liabilities: Embedded derivative liability $ 2,157 $ — $ — $ 2,157 Total liabilities measured at fair value $ 2,157 $ — $ — $ 2,157 |
Summary of the changes in the estimated fair value of the Company’s embedded derivative | The following table sets forth changes in Level 3 liabilities measured at fair value on a recurring basis for the three and six months ended June 30, 2020 and 2019 (in thousands): Three Months Ended Six Months Ended 2020 2019 2020 2019 Beginning balance $ 2,498 $ 1,453 $ 2,157 $ 1,352 Change in fair value included in interest and other income, net 97 48 438 149 Ending balance $ 2,595 $ 1,501 $ 2,595 $ 1,501 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020 and December 31, 2019 (in thousands): June 30, 2020 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Investments: Corporate debt $ 13,718 $ 74 $ — $ 13,792 U.S. Treasury securities 59,038 47 (1) 59,084 Commercial paper — Total $ 72,756 $ 121 $ (1) $ 72,876 Reported as: Short-term investments $ 72,756 $ 121 $ (1) $ 72,876 Total $ 72,756 $ 121 $ (1) $ 72,876 December 31, 2019 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Investments: Corporate debt $ 22,582 $ 3 $ (9) $ 22,576 U.S. Treasury securities 37,789 22 — 37,811 Commercial paper 6,446 — — 6,446 Total $ 66,817 $ 25 $ (9) $ 66,833 Reported as: Short-term investments $ 66,817 $ 25 $ (9) $ 66,833 Total $ 66,817 $ 25 $ (9) $ 66,833 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consists of the following (in thousands): June 30, 2020 December 31, 2019 Raw materials $ 804 $ 1,057 Work-in-process 3,229 1,925 Finished goods 1,818 2,285 Total inventory $ 5,851 $ 5,267 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of payment obligations under the Royalty-Backed Loan | Payment obligations under the Royalty-Backed Loan are as follows (in thousands): June 30, 2020 December 31, 2019 Total repayment obligation $ 200,000 $ 200,000 Less: Interest to be accreted in future periods (56,126) (63,217) Less: Payments made (14,342) (9,068) Carrying value of loans payable $ 129,532 $ 127,715 Less: Current portion of long-term debt (3,232) (2,041) Non-current portion of long-term debt $ 126,300 $ 125,674 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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: June 30, 2020 December 31, 2019 Common stock awards issued and outstanding 7,076,844 6,874,633 Authorized for future issuance under 2014 Equity Incentive Plan 3,262,732 2,376,613 Authorized for future issuance under 2016 Inducement Plan 494,562 236,269 Employee stock purchase plan 1,111,497 926,943 Total 11,945,635 10,414,458 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of allocation of total stock-based compensation expense | The following table reflects stock-based compensation expense recognized for the three and six months ended June 30, 2020 and 2019 (in thousands): Three Months Ended Six Months Ended 2020 2019 2020 2019 Research and development $ 134 $ 563 $ 220 $ 1,153 Selling, general and administrative 1,561 2,376 2,956 5,170 Total stock-based compensation expense $ 1,695 $ 2,939 $ 3,176 $ 6,323 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 and Six Months Ended 2020 2019 Options to purchase common stock 5,450 5,716 Restricted stock units 1,627 900 Total 7,077 6,616 |
Description of Business (Detail
Description of Business (Details) | 6 Months Ended |
Jun. 30, 2020segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | May 31, 2017 | Dec. 31, 2017 | Jun. 30, 2020 | Dec. 31, 2017 | Nov. 30, 2019 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Proceeds from public offerings, net of offering costs | $ 134,300,000 | |||||
Cash, cash equivalents, and investments | $ 103,400,000 | |||||
HCRP | Royalty-backed loan agreement | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Proceeds from issuance of debt | $ 35,000,000 | $ 65,000,000 | $ 100,000,000 | |||
Cowen | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
At-the-market offering, aggregate offering price (up to) | $ 50,000,000 | |||||
Sale of shares under the sales agreement (in shares) | 0 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Which Require Fair Value Measurement (Details) - Recurring basis - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Assets: | ||
Total assets measured at fair value | $ 83,830 | $ 99,035 |
Liabilities: | ||
Total liabilities measured at fair value | 2,595 | 2,157 |
Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 2,595 | 2,157 |
Level 1 | ||
Assets: | ||
Total assets measured at fair value | 10,954 | 27,720 |
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 | 72,876 | 71,315 |
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 | 2,595 | 2,157 |
Level 3 | Embedded derivative liability | ||
Liabilities: | ||
Total liabilities measured at fair value | 2,595 | 2,157 |
Money market | ||
Assets: | ||
Total assets measured at fair value | 10,954 | 27,720 |
Money market | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 10,954 | 27,720 |
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 | 13,792 | 22,576 |
Corporate debt | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Corporate debt | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 13,792 | 22,576 |
Corporate debt | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury securities | ||
Assets: | ||
Total assets measured at fair value | 59,084 | 37,811 |
U.S. Treasury securities | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
U.S. Treasury securities | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 59,084 | 37,811 |
U.S. Treasury securities | Level 3 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Commercial paper | ||
Assets: | ||
Total assets measured at fair value | 0 | 10,928 |
Commercial paper | Level 1 | ||
Assets: | ||
Total assets measured at fair value | 0 | 0 |
Commercial paper | Level 2 | ||
Assets: | ||
Total assets measured at fair value | 0 | 10,928 |
Commercial paper | Level 3 | ||
Assets: | ||
Total assets measured at fair value | $ 0 | $ 0 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) - Level 3 - Embedded derivative liability | Jun. 30, 2020 |
Measurement Input, Discount Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.196 |
Measurement Input, Change In Control Probability | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.030 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Estimated Fair Value of Embedded Derivative (Details) - Level 3 - Long-term debt with embedded derivative - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Beginning balance | $ 2,498 | $ 1,453 | $ 2,157 | $ 1,352 |
Change in fair value included in interest and other income, net | 97 | 48 | 438 | 149 |
Ending balance | $ 2,595 | $ 1,501 | $ 2,595 | $ 1,501 |
Investments (Details)
Investments (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Available-for-sale securities | |||||
Amortized Cost | $ 72,756,000 | $ 72,756,000 | $ 66,817,000 | ||
Gross Unrealized Gains | 121,000 | 121,000 | 25,000 | ||
Gross Unrealized Losses | (1,000) | (1,000) | (9,000) | ||
Fair Value | 72,876,000 | 72,876,000 | 66,833,000 | ||
Debt securities, available-for-sale, realized gain | 55,000 | $ 0 | 55,000 | $ 0 | |
Debt securities, available-for-sale, realized loss | 0 | $ 0 | 0 | $ 0 | |
Short-term investments | |||||
Available-for-sale securities | |||||
Amortized Cost | 72,756,000 | 72,756,000 | 66,817,000 | ||
Gross Unrealized Gains | 121,000 | 121,000 | 25,000 | ||
Gross Unrealized Losses | (1,000) | (1,000) | (9,000) | ||
Fair Value | 72,876,000 | 72,876,000 | 66,833,000 | ||
Accrued interest | 200,000 | $ 200,000 | $ 400,000 | ||
Long-term investments | Maximum | |||||
Available-for-sale securities | |||||
Maturity of long term investment | 12 months | 12 months | |||
Corporate debt | |||||
Available-for-sale securities | |||||
Amortized Cost | 13,718,000 | $ 13,718,000 | $ 22,582,000 | ||
Gross Unrealized Gains | 74,000 | 74,000 | 3,000 | ||
Gross Unrealized Losses | 0 | 0 | (9,000) | ||
Fair Value | 13,792,000 | 13,792,000 | 22,576,000 | ||
U.S. Treasury securities | |||||
Available-for-sale securities | |||||
Amortized Cost | 59,038,000 | 59,038,000 | 37,789,000 | ||
Gross Unrealized Gains | 47,000 | 47,000 | 22,000 | ||
Gross Unrealized Losses | (1,000) | (1,000) | 0 | ||
Fair Value | 59,084,000 | 59,084,000 | 37,811,000 | ||
Commercial paper | |||||
Available-for-sale securities | |||||
Amortized Cost | 6,446,000 | ||||
Gross Unrealized Gains | 0 | ||||
Gross Unrealized Losses | 0 | ||||
Fair Value | $ 0 | $ 0 | $ 6,446,000 |
Inventory (Details)
Inventory (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |||
Provision for write-down of inventory | $ 340,000 | $ 0 | |
Raw materials | 804,000 | $ 1,057,000 | |
Work-in-process | 3,229,000 | 1,925,000 | |
Finished goods | 1,818,000 | 2,285,000 | |
Total inventory | $ 5,851,000 | $ 5,267,000 |
License Agreements (Details)
License Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Nov. 30, 2012 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
License Agreements | |||||
Revenues | $ 18,794,000 | $ 12,691,000 | $ 33,275,000 | $ 24,356,000 | |
Period describing the commercial launch of dose | 15 years | ||||
Royalty | |||||
License Agreements | |||||
Revenues | 840,000 | 0 | $ 840,000 | 0 | |
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 | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Billions | Jun. 30, 2020USD ($)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 - Narrative (Det
Long-term Debt - Narrative (Details) - USD ($) | Apr. 29, 2020 | Apr. 15, 2020 | May 31, 2017 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2017 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2017 |
Debt Instrument [Line Items] | |||||||||
Proceeds from PPP Loan | $ 2,700,000 | $ 2,650,000 | $ 0 | ||||||
Repayments of PPP loan | $ 2,700,000 | 2,650,000 | 0 | ||||||
HCRP | Royalty-backed loan agreement | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from issuance of debt | $ 35,000,000 | $ 65,000,000 | $ 100,000,000 | ||||||
Percentage revenue interest of future net sales | 12.50% | ||||||||
Quarterly royalty payment (up to) | $ 15,000,000 | ||||||||
Royalty percentage of future net sales | 6.25% | ||||||||
Royalty trail cap, percentage of face amount | 200.00% | ||||||||
Voluntary prepay election, amount due, percentage of funded amount | 200.00% | ||||||||
Interest rate, stated percentage | 11.00% | ||||||||
Unpaid interest payment added to principal amount, term | 2 years 3 months | ||||||||
Contingent consideration, asset | $ 65,000,000 | $ 65,000,000 | |||||||
Lender expense | $ 400,000 | ||||||||
Payment of debt issuance costs | $ 800,000 | ||||||||
Interest expense | $ 3,500,000 | $ 3,800,000 | $ 7,100,000 | $ 7,500,000 | |||||
Effective interest rate | 13.00% | 13.00% | |||||||
HCRP | Royalty-backed loan agreement | Level 3 | |||||||||
Debt Instrument [Line Items] | |||||||||
Long-term debt, fair value | $ 100,800,000 | $ 100,800,000 | |||||||
HCRP | Royalty-backed loan agreement | December 2021 | |||||||||
Debt Instrument [Line Items] | |||||||||
Royalty percentage of future net sales if principal and interest payments below minimum specified levels (up to) | 17.50% | ||||||||
HCRP | Royalty-backed loan agreement | December 2022 | |||||||||
Debt Instrument [Line Items] | |||||||||
Royalty percentage of future net sales if principal and interest payments below minimum specified levels (up to) | 22.50% |
Long-term Debt - Long-term Debt
Long-term Debt - Long-term Debt and Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Less: Current portion of long-term debt | $ (3,232) | $ (2,041) |
Long-term debt | 126,300 | 125,674 |
HCRP | Royalty-backed loan agreement | ||
Debt Instrument [Line Items] | ||
Total repayment obligation | 200,000 | 200,000 |
Less: Interest to be accreted in future periods | (56,126) | (63,217) |
Less: Payments made | (14,342) | (9,068) |
Carrying value of loans payable | 129,532 | 127,715 |
Less: Current portion of long-term debt | (3,232) | (2,041) |
Long-term debt | $ 126,300 | $ 125,674 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 6 Months Ended | ||
Jun. 30, 2020USD ($)voteshares | Dec. 31, 2019shares | Nov. 30, 2019USD ($) | |
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 | ||
Total common stock reserved for future issuance (in shares) | 11,945,635 | 10,414,458 | |
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% | ||
Sale of shares under the sales agreement (in shares) | 0 | ||
Employee Stock Purchase Plan | |||
Shareholders' Equity | |||
Total common stock reserved for future issuance (in shares) | 1,111,497 | 926,943 | |
Stock options | |||
Shareholders' Equity | |||
Total common stock reserved for future issuance (in shares) | 7,076,844 | 6,874,633 | |
Stock options | 2014 Equity Incentive Plan | |||
Shareholders' Equity | |||
Authorized for future issuance (in shares) | 3,262,732 | 2,376,613 | |
Stock options | 2016 Inducement Plan | |||
Shareholders' Equity | |||
Authorized for future issuance (in shares) | 494,562 | 236,269 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Feb. 29, 2020 | Jan. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock Option Plans | ||||||
Stock-based compensation capitalized in inventory | $ 45 | $ 34 | $ 153 | $ 60 | ||
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) | 279,648 | |||||
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) | 1,118,591 | |||||
2016 Inducement Plan | ||||||
Stock Option Plans | ||||||
Company’s additional common stock available for issuance (in shares) | 450,000 |
Stock-Based Compensation - Inco
Stock-Based Compensation - Income Statement Location (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 1,695 | $ 2,939 | $ 3,176 | $ 6,323 |
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 134 | 563 | 220 | 1,153 |
Selling, general and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 1,561 | $ 2,376 | $ 2,956 | $ 5,170 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities (in shares) | 7,077 | 6,616 | 7,077 | 6,616 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities (in shares) | 5,450 | 5,716 | 5,450 | 5,716 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities (in shares) | 1,627 | 900 | 1,627 | 900 |