Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 14, 2020 | Jun. 30, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Transition Report | false | ||
Entity File Number | 001-36152 | ||
Entity Registrant Name | Aerie Pharmaceuticals, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-3109565 | ||
Entity Address, Address Line One | 4301 Emperor Boulevard, | ||
Entity Address, Address Line Two | Suite 400 | ||
Entity Address, City or Town | Durham, | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27703 | ||
City Area Code | 919 | ||
Local Phone Number | 237-5300 | ||
Title of 12(b) Security | Common Stock, $0.001 par value per share | ||
Trading Symbol | AERI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,334,440,206 | ||
Entity Common Stock, Shares Outstanding | 46,428,456 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement (the “Proxy Statement”) for the 2020 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K. The Proxy Statement will be filed with the Securities and Exchange Commission (the “SEC”) within 120 days of the registrant’s fiscal year ended December 31, 2019 . | ||
Entity Central Index Key | 0001337553 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 143,940 | $ 202,818 |
Short-term investments | 165,250 | 0 |
Accounts receivable, net | 38,354 | 2,715 |
Inventory | 21,054 | 10,112 |
Prepaid expenses and other current assets | 7,744 | 4,530 |
Total current assets | 376,342 | 220,175 |
Property, plant and equipment, net | 58,147 | 60,525 |
Operating lease right-of-use assets | 16,523 | |
Other assets | 1,596 | 4,344 |
Total assets | 452,608 | 285,044 |
Current liabilities | ||
Accounts payable | 12,770 | 12,403 |
Accrued expenses and other current liabilities | 65,376 | 38,381 |
Operating lease liabilities | 5,502 | |
Total current liabilities | 83,648 | 50,784 |
Convertible notes, net | 188,651 | 0 |
Long-term operating lease liabilities | 12,102 | |
Other non-current liabilities | 1,257 | 6,454 |
Total liabilities | 285,658 | 57,238 |
Commitments and contingencies (Note 14) | ||
Stockholders’ equity | ||
Preferred stock, $0.001 par value; 15,000,000 shares authorized as of December 31, 2019 and December 31, 2018; None issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 150,000,000 shares authorized as of December 31, 2019 and December 31, 2018; 46,464,669 and 45,478,883 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively | 46 | 45 |
Additional paid-in capital | 1,062,996 | 924,180 |
Accumulated other comprehensive loss | (92) | 0 |
Accumulated deficit | (896,000) | (696,419) |
Total stockholders’ equity | 166,950 | 227,806 |
Total liabilities and stockholders’ equity | $ 452,608 | $ 285,044 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 46,464,669 | 45,478,883 |
Common stock, shares outstanding (in shares) | 46,464,669 | 45,478,883 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Total revenues, net | $ 69,888 | $ 24,181 | $ 0 |
Costs and expenses: | |||
Cost of goods sold | 4,833 | 641 | 0 |
Selling, general and administrative | 138,402 | 120,614 | 56,905 |
Pre-approval commercial manufacturing | 22,767 | 26,545 | 16,710 |
Research and development | 91,378 | 86,123 | 72,078 |
Total costs and expenses | 257,380 | 233,923 | 145,693 |
Loss from operations | (187,492) | (209,742) | (145,693) |
Other (expense) income, net | (12,179) | (22,824) | (1,170) |
Loss before income taxes | (199,671) | (232,566) | (146,863) |
Income tax (benefit) expense | (90) | 3 | (1,758) |
Net loss | $ (199,581) | $ (232,569) | $ (145,105) |
Net loss per common share - basic and diluted (in dollars per share) | $ (4.39) | $ (5.58) | $ (4.11) |
Weighted average number of common shares outstanding—basic and diluted (in shares) | 45,427,154 | 41,663,958 | 35,324,472 |
Net loss | $ (199,581) | $ (232,569) | $ (145,105) |
Unrealized (loss) gain on available-for-sale investments | (92) | 28 | 40 |
Comprehensive loss | (199,673) | (232,541) | (145,065) |
Product revenues, net | |||
Total revenues, net | $ 69,888 | $ 24,181 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2016 | 33,458,607 | ||||
Beginning balance, value at Dec. 31, 2016 | $ 105,344 | $ 33 | $ 422,002 | $ (68) | $ (316,623) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of commissions and expenses (in shares) | 2,506,387 | ||||
Issuance of common stock, net of discounts, commissions and expenses | 133,812 | $ 2 | 133,810 | ||
Issuance of common stock upon exercise of stock purchase rights (in shares) | 27,953 | ||||
Issuance of common stock upon exercise of stock purchase rights | 1,050 | 1,050 | |||
Issuance of common stock upon exercise of stock options and warrants (in shares) | 201,592 | ||||
Issuance of common stock upon exercise of stock options and warrants | 828 | $ 1 | 827 | ||
Issuance of common stock for restricted stock awards, net (in shares) | 489,952 | ||||
Issuance of common stock for restricted stock awards, net | (750) | $ 1 | (751) | ||
Shares issued for asset acquisition (in shares) | 263,146 | ||||
Shares issued for asset acquisition | 14,302 | 14,302 | |||
Stock-based compensation | 26,078 | 26,078 | |||
Other comprehensive income | 40 | 40 | |||
Net loss | (145,105) | (145,105) | |||
Ending balance (in shares) at Dec. 31, 2017 | 36,947,637 | ||||
Ending balance, value at Dec. 31, 2017 | 135,599 | $ 37 | 597,318 | (28) | (461,728) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of commissions and expenses (in shares) | 2,313,824 | ||||
Issuance of common stock, net of discounts, commissions and expenses | 136,445 | $ 2 | 136,443 | ||
Issuance of common stock upon exercise of stock purchase rights (in shares) | 34,193 | ||||
Issuance of common stock upon exercise of stock purchase rights | 1,401 | 1,401 | |||
Issuance of common stock upon exercise of stock options and warrants (in shares) | 597,777 | ||||
Issuance of common stock upon exercise of stock options and warrants | 4,251 | $ 1 | 4,250 | ||
Issuance of common stock for restricted stock awards, net (in shares) | 216,005 | ||||
Issuance of common stock for restricted stock awards, net | (2,172) | (2,172) | |||
Issuance of shares upon conversion of 2014 Convertible Notes (in shares) | 5,369,447 | ||||
Issuance of shares upon conversion of 2014 Convertible Notes | 148,083 | $ 5 | 148,078 | ||
Stock-based compensation | 38,862 | 38,862 | |||
Other comprehensive income | 28 | 28 | |||
Net loss | (232,569) | (232,569) | |||
Ending balance (in shares) at Dec. 31, 2018 | 45,478,883 | ||||
Ending balance, value at Dec. 31, 2018 | 227,806 | $ 45 | 924,180 | 0 | (696,419) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock purchase rights (in shares) | 42,611 | ||||
Issuance of common stock upon exercise of stock purchase rights | $ 979 | 979 | |||
Issuance of common stock upon exercise of stock options and warrants (in shares) | 287,148 | 612,759 | |||
Issuance of common stock upon exercise of stock options and warrants | $ 3,140 | 3,140 | |||
Issuance of common stock for restricted stock awards, net (in shares) | 330,416 | ||||
Issuance of common stock for restricted stock awards, net | (2,629) | $ 1 | (2,630) | ||
Stock-based compensation | 45,551 | 45,551 | |||
Other comprehensive income | (92) | (92) | |||
Equity component of Convertible Notes, net of issuance costs of $3,725 | 124,666 | 124,666 | |||
Payment for capped call share options | (32,890) | (32,890) | |||
Net loss | (199,581) | (199,581) | |||
Ending balance (in shares) at Dec. 31, 2019 | 46,464,669 | ||||
Ending balance, value at Dec. 31, 2019 | $ 166,950 | $ 46 | $ 1,062,996 | $ (92) | $ (896,000) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Stockholders' Equity [Abstract] | |||
Underwriting discounts and commissions and expenses | $ 1,345 | $ 3,458 | |
Issuance costs, equity component of convertible debt | $ 3,725 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | |||
Net loss | $ (199,581) | $ (232,569) | $ (145,105) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Depreciation | 5,138 | 2,442 | 1,410 |
Amortization and accretion | 12,976 | 1,646 | 315 |
Acquisition of assets expensed to research and development | 10,171 | 0 | 24,802 |
Stock-based compensation | 45,093 | 38,728 | 26,078 |
Induced conversion of 2014 Convertible Notes | 0 | 24,059 | 0 |
Other non-cash | (271) | (270) | 601 |
Changes in operating assets and liabilities | |||
Accounts receivable, net | (35,639) | (2,715) | 0 |
Inventory | (10,257) | (9,689) | 0 |
Prepaid, current and other assets | (2,144) | (791) | (2,239) |
Accounts payable, accrued expenses and other current liabilities | 28,766 | 26,583 | 925 |
Operating lease liabilities | (4,682) | ||
Net cash used in operating activities | (150,430) | (152,576) | (93,213) |
Cash flows from investing activities | |||
Acquisition of assets | (7,835) | 0 | (10,500) |
Purchase of available-for-sale investments | (165,454) | (56,195) | (104,490) |
Proceeds from sales and maturities of investments | 0 | 108,297 | 88,153 |
Purchase of property, plant and equipment | (9,958) | (31,313) | (15,970) |
Net cash (used in) provided by investing activities | (183,247) | 20,789 | (42,807) |
Cash flows from financing activities | |||
Proceeds from sale of common stock, net | 0 | 135,972 | 134,215 |
Proceeds related to issuance of stock for stock-based compensation arrangements, net | 684 | 3,630 | 1,429 |
Proceeds from exercise of warrants | 761 | 0 | 0 |
Proceeds from convertible notes, net of issuance costs | 308,349 | 0 | 0 |
Payments of issuance costs | (1,769) | (1,883) | 0 |
Payment for capped call options | (32,890) | 0 | 0 |
Other financing | (336) | (683) | 0 |
Net cash provided by financing activities | 274,799 | 137,036 | 135,644 |
Net change in cash and cash equivalents | (58,878) | 5,249 | (376) |
Cash and cash equivalents, at beginning of period | 202,818 | 197,569 | 197,945 |
Cash and cash equivalents, at end of period | 143,940 | 202,818 | 197,569 |
Supplemental disclosures | |||
Cash paid for interest | 6,496 | 1,774 | 2,188 |
Non-cash investing and financing activities: | |||
Conversion of convertible notes to common stock (Note 10) | 0 | 148,078 | 0 |
Equity issued for Envisia Asset Acquisition | 0 | 0 | 14,302 |
Liabilities incurred from Avizorex Asset Acquisition | 1,186 | 0 | 0 |
Purchases of property, plant and equipment in accounts payable and accrued expense and other current liabilities | 771 | 3,526 | 4,176 |
Acquisition of capital lease obligation | 0 | 0 | 689 |
Deferred costs from the sale of common stock | 0 | 0 | 403 |
Build-to-suit lease transaction (Note 7) |
The Company
The Company | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company | The Company Aerie Pharmaceuticals, Inc. (“Aerie”), with its wholly-owned subsidiaries, Aerie Distribution, Inc., Aerie Pharmaceuticals Limited and Aerie Pharmaceuticals Ireland Limited (“Aerie Distribution,” “Aerie Limited” and “Aerie Ireland Limited,” respectively, together with Aerie, the “Company”), is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, dry eye, retinal diseases and potentially other diseases of the eye. The Company has its principal executive offices in Durham, North Carolina, and operates as one business segment. The Company has two U.S. Food and Drug Administration (“FDA”) approved products, Rhopressa ® (netarsudil ophthalmic solution) 0.02% (“Rhopressa ® ”) and Rocklatan ® (netarsudil/latanoprost ophthalmic solution) 0.02% / 0.005% (“Rocklatan ® ”). Rhopressa ® is a once-daily eye drop designed to reduce elevated intraocular pressure (“IOP”) in patients with open-angle glaucoma or ocular hypertension. Rocklatan ® is a once-daily fixed-dose combination of Rhopressa ® and latanoprost, the most widely-prescribed drug for the treatment of patients with open-angle glaucoma. The Company is commercializing Rhopressa ® , which was launched in the United States at the end of April 2018, and Rocklatan ® , which was launched in the United States in May 2019. In November 2019, the Company released topline data from its Phase 4 Multi-center Open-label Study (“MOST”), which observed Rhopressa ® efficacy in various real-world clinical settings, including as an adjunctive product and monotherapy. The results indicated positive IOP reduction in all settings, along with a favorable tolerability profile. In addition to actively promoting the products in the United States, the Company is pursuing its strategy to obtain regulatory approval for Rhopressa ® and Rocklatan ® in Europe and Japan. Rhopressa ® and, if approved, Rocklatan ® will be marketed under the names Rhokiinsa ® and Roclanda ® , respectively, in Europe. In Europe, Rhokiinsa ® was granted a centralised marketing authorisation by the European Commission (“EC”) in November 2019 and the Marketing Authorisation Application (“MAA”) for Roclanda ® was accepted by the European Medicines Agency (“EMA”) in December 2019. The Phase 3 registration trial for Roclanda ® , named Mercury 3, is a six-month efficacy and safety trial designed to compare Roclanda ® to Ganfort ® , a fixed-dose combination product marketed in Europe of bimatoprost (a PGA), and timolol (a beta blocker). If successful, Mercury 3 is expected to improve the commercialization prospects of Roclanda ® in Europe; it is not required for regulatory approval. The Mercury 3 results are expected to be an important determinant as the Company evaluates the commercialization and profitability potential of Rhokiinsa ® and Roclanda ® in Europe. The Company currently expects to read out topline 90-day efficacy data for the trial in the second half of 2020 . In Japan, with respect to the clinical progress of Rhopressa ® , the Company completed a Phase 1 clinical trial, a successful pilot Phase 2 clinical study in the United States on Japanese and Japanese-American subjects, as well as a Phase 2 clinical trial conducted in Japan. These studies were designed to meet the requirements of Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) for potential regulatory submission of Rhopressa ® in Japan. Topline results of the Phase 2 trial indicated positive efficacy and tolerability in the patient set. Clinical trials for Rocklatan ® have not yet begun. The Company expects to move forward with plans for Phase 3 initiation in Japan for Rhopressa ® , along with exploring collaboration with a potential partner in Japan to advance the Company’s clinical development and ultimately commercialize Rhopressa ® and Rocklatan ® in Japan, and will continue to explore other potential opportunities elsewhere in Eastern Asia. The Company is also focused on furthering the development of its product candidates focused on dry eye and retinal diseases, particularly AVX-012, AR-1105 and AR-13503 SR, described below. The Company acquired Avizorex Pharma S.L. (“Avizorex”), a Spanish ophthalmic pharmaceutical company, developing therapeutics for the treatment of dry eye disease. The active ingredient in AVX-012 is a potent and selective agonist of the TRPM8 ion channel, a cold sensor and osmolarity sensor that regulates ocular surface wetness and blink rate. The Company is planning to initiate a large Phase 2b study in late 2020 . The Company has also acquired worldwide ophthalmic rights to a bio-erodible polymer technology from DSM, a global science-based company headquartered in the Netherlands, and PRINT ® (Particle Replication in Non-wetting Templates) implant manufacturing technology, which is a proprietary technology capable of creating precisely-engineered sustained-release products utilizing fully-scalable manufacturing processes, from Envisia Therapeutics Inc. (“Envisia”). Using these technologies, the Company has created a sustained-release ophthalmology platform and is currently developing two sustained-release implants focused on retinal diseases, AR-1105 and AR-13503 SR. AR-1105 is a dexamethasone steroid implant, for which the Company has completed enrollment in a Phase 2 clinical trial in patients with macular edema due to retinal vein occlusion (“RVO”). The Company is also developing AR-13503, a ROCK and Protein kinase C inhibitor that is the active ingredient in the AR-13503 sustained-release implant. The Investigational New Drug application (“IND”) for AR-13503 SR became effective in April 2019, allowing the Company to initiate human studies in the treatment of neovascular age-related macular degeneration (“nAMD”) and diabetic macular edema (“DME”). The Company initiated a first-in human clinical study for AR-13503 SR in the third quarter of 2019. In November 2019, the Company entered into a Share Purchase Agreement (the “Agreement”) with Avizorex, under which the Company acquired Avizorex, including its lead product candidate AVX-012, for which Avizorex completed a Phase 2a study in dry eye subjects in 2019. The consideration given for the Avizorex acquisition was $10.2 million . Additionally, the Company agreed to make potential milestone payments of up to an aggregate of $69.0 million , contingent upon the achievement of certain clinical and product regulatory approvals, plus royalties on net sales of any approved products from Avizorex’s development pipeline. Under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 805: Business Combinations (“ASC Topic 805”), including the provisions of Accounting Standards Update (“ASU”) 2017-01, the Company accounted for the transaction as an asset acquisition rather than a business combination, and expensed $10.2 million of acquired in-process research and development (“IPR&D”) to research and development in the consolidated statement of operations and comprehensive loss during the three months ended December 31, 2019. In addition, any milestone payments will be recognized only once the contingency is resolved and such amounts are payable. In October 2017, the Company entered into an Asset Purchase Agreement (the “Envisia Agreement”) with Envisia to acquire the rights to use PRINT ® technology in ophthalmology, as well as rights relating to a preclinical dexamethasone steroid implant for the potential treatment of RVO and DME that utilizes the PRINT ® technology, referred to as AR-1105. Under the terms of the Envisia Agreement, the Company (a) made an upfront cash payment of $10.5 million and issued 263,146 shares of Aerie’s common stock valued at approximately $14.3 million and (b) agreed to make potential milestone payments of up to an aggregate of $45.0 million , contingent upon the achievement of certain product regulatory approvals. Under the provisions of ASC Topic 805, including the provisions of ASU 2017-01 (see Note 2), the Company accounted for the transaction as an asset acquisition rather than a business combination, and expensed $24.8 million of acquired IPR&D to research and development in the consolidated statement of operations and comprehensive loss during the three months ended December 31, 2017. In addition, any milestone payments will be recognized only once the contingency is resolved and such amounts are payable. In July 2017, the Company entered into a collaborative research, development and licensing agreement with DSM, which included an option to license DSM’s bio-erodible polymer implant technology for sustained delivery of certain Aerie compounds to treat ophthalmic diseases. This technology uses polyesteramide polymers to produce an injectable, thin fiber that is minute in size. On August 1, 2018, the Company entered into an Amended and Restated Collaborative Research, Development, and License Agreement with DSM (the “Collaboration Agreement”), which provides for (i) a worldwide exclusive license for all ophthalmic indications to DSM’s polyesteramide polymer technology, (ii) continuation of the collaborative research initiatives through the end of 2020, including the transfer of DSM’s formulation technology to Aerie during that time and (iii) access to a preclinical latanoprost implant. Aerie paid $6.0 million to DSM upon execution of the Collaboration Agreement, with an additional $9.0 million payable to DSM through the end of 2020. As a result, $9.6 million related to the expanded collaboration agreement with DSM was expensed to research and development expense during the year ended December 31, 2018, which included the upfront payment of $6.0 million . The Collaboration Agreement includes contingent payments of up to $75.0 million that may be due to DSM upon the achievement of certain development and regulatory milestones. In addition, pursuant to the Collaboration Agreement, a $3.0 million milestone payment was made during the year ended December 31, 2018 upon the completion of certain manufacturing technology transfer activities. Aerie would also pay royalties to DSM when products are commercialized under this Collaboration Agreement, if any. The Company commenced generating product revenues related to the sales in the United States of Rhopressa ® in the second quarter of 2018 and Rocklatan ® in the second quarter of 2019. The Company’s activities prior to the commercial launch of Rhopressa ® had primarily consisted of developing product candidates, raising capital and performing research and development activities. The Company has incurred losses and experienced negative operating cash flows since inception. The Company had previously funded its operations primarily through the sale of equity securities (Note 12 ) and issuance of convertible notes (Note 10 ) prior to generating product revenues. In September 2019, the Company issued an aggregate principal amount of $316.25 million of 1.50% convertible senior notes due 2024 (the “Convertible Notes”) and simultaneously terminated its $200 million senior secured delayed draw term loan facility (the “credit facility”). See Note 10 for additional information. If the Company does not successfully commercialize Rhopressa ® and Rocklatan ® or any current or future product candidates, if approved, it may not generate sufficient cash flows and may be unable to achieve profitability. Accordingly, the Company may be required to obtain further funding through debt or equity offerings or other sources. Adequate additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on acceptable terms, it may be forced to delay, reduce or eliminate its research and development programs or commercialization and manufacturing efforts. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies Basis of Presentation and Consolidation The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of Aerie and its wholly-owned subsidiaries. All intercompany accounts, transactions and profits have been eliminated in consolidation. Certain reclassifications have been made to prior year amounts to conform to the current year presentation. Use of Estimates The preparation of 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 and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, acquisitions, stock-based compensation and fair value measurements. Actual results could differ from the Company’s estimates. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment. Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents and investments. The Company’s cash and cash equivalents, which include short-term highly liquid investments with original maturities of three months or less, are held at several financial institutions. The Company’s investment policy permits investments in U.S. federal government and federal agency securities, corporate bonds or commercial paper, money market instruments, and certain qualifying money market mutual funds, and places restrictions on credit ratings, maturities, and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments to the extent recorded on the consolidated balance sheet. The Company relies on its third-party manufacturers to produce the active pharmaceutical ingredient (“API”) and final drug product for Rhopressa ® and Rocklatan ® and may rely on third-party manufacturers for its current and future product candidates. In addition to the current contract manufacturers, the Company obtained FDA approval for an additional Rhopressa ® drug product contract manufacturer in the first quarter of 2019, which began to supply commercial product in the second quarter of 2019. Further, the Company has obtained FDA approval for an additional API contract manufacturer, which began to supply commercial API in the second quarter of 2019. The Company has also received approval of an additional Rocklatan ® drug product contract manufacturer in January 2020. In addition, the Company has established its own manufacturing plant in Athlone, Ireland, for future commercial production of Rocklatan ® and Rhopressa ® , if approved, and thereafter, potentially Rhokiinsa ® and, if approved, Roclanda ® . In January 2020, the Company received FDA approval to produce Rocklatan ® at the Athlone plant for commercial distribution in the United States. This approval follows a successful pre-approval inspection of the plant and FDA review of the New Drug Application (“NDA”) Prior Approval Supplement (“PAS”), which added the Athlone manufacturing plant as a drug product manufacturer for Rocklatan ® . The Company expects FDA approval to produce Rhopressa ® at the Athlone plant by the end of 2020. The Company expects to continue to use product sourced from the contract manufacturers in addition to the manufacturing plant in Athlone, Ireland. Revenue Recognition The Company accounts for its revenue transactions under FASB ASC Topic 606, Revenue from Contracts with Customers . In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied. Aerie’s customers include a limited number of national and select regional wholesalers (the “distributors”). These distributors subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue is typically recognized when distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of product to the distributors. The Company evaluates the creditworthiness of each of its distributors to determine whether it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company does not assess whether a contract has a significant financing component if the expectation is such that the period between the transfer of the promised goods to the customer and the receipt of payment will be less than one year. Standard credit terms do not exceed 75 days. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would have been recognized is one year or less or the amount is immaterial. Shipping and handling costs related to the Company’s product sales are included in selling, general and administrative expenses. The Company’s net product revenues through December 31, 2019 were generated through sales of Rhopressa ® , which was commercially launched in the United States at the end of April 2018, and sales of Rocklatan ® , which was commercially launched in the United States in May 2019. Product revenue is recorded net of trade discounts, allowances, commercial and government rebates, co-pay program coupons, chargebacks, U.S. government funding requirements for the coverage gap (commonly called the “donut hole”) portion of the Medicare Part D program and estimated returns and other incentives. These reserves are classified as either reductions of accounts receivable or as current liabilities. The estimates of reserves established for variable consideration reflect current contractual and statutory requirements, known market events and trends, industry data, forecasted customer mix and lagged claims. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net product revenues only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from these estimates. If actual results vary, estimates may be adjusted in the period such change in estimate becomes known, which could have an impact on earnings in the period of adjustment. See Note 3 for additional information. Cash Equivalents The Company’s cash and cash equivalents are held at several financial institutions. The Company considers money market accounts and short-term highly liquid investments with original maturities of three months or less to be cash equivalents. Inventories Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out (“FIFO”) method. The Company analyzes its inventory levels at least quarterly and writes down inventory that is expected to expire prior to being sold, inventory in excess of expected sales requirements and inventory that fails to meet commercial sale specifications, with a corresponding charge to cost of goods sold. The determination of whether inventory costs will be realizable requires estimates by management of future expected inventory requirements based on sales forecasts. If actual net realizable value is less than the estimated amount or if actual market conditions are less favorable than the Company’s projections, additional inventory write-downs may be required. Charges for inventory write-downs are not reversed if it is later determined that the product is saleable. Prior to the date the Company obtains regulatory approval for its product candidates or its manufacturing facilities such as its manufacturing plant in Athlone, Ireland, manufacturing costs related to commercial production are expensed as pre-approval commercial manufacturing expense on the consolidated statements of operations and comprehensive loss. Once regulatory approval is obtained, the Company capitalizes such costs as inventory on the consolidated balance sheets. Property, Plant and Equipment, Net Property, plant and equipment is recorded at historical cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. Construction-in-progress reflects amounts incurred for property, plant or equipment construction or improvements that have not been yet placed in service and are not depreciated or amortized, which primarily relates to the completion of the build-out of the Company’s manufacturing plant in Ireland. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the determination of net loss. Estimated useful lives by major asset category are as follows: Manufacturing equipment 10 years Laboratory equipment 7 years Furniture and fixtures 5 years Software, computer and other equipment 3 years Leasehold improvements Lower of estimated useful life or term of lease Leases The Company determines if an arrangement is a lease at inception. For each lease, the lease term is determined at the commencement date and includes renewal options and termination options when it is reasonably certain that the Company will exercise that option. Operating leases with lease terms greater than one year are included in operating lease right-of-use (“ROU”) assets and current and long-term operating lease liabilities in the Company’s consolidated balance sheets. Operating lease ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term using an estimated rate of interest the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease ROU assets are based on the liability adjusted for any prepaid or deferred rent and lease incentives. The incremental borrowing rate was utilized to discount lease payments over the expected term given that the Company’s operating leases do not provide an implicit rate. The Company estimates the incremental borrowing rate to reflect the profile of secured borrowing over the expected term of the leases based on the information available at the later of the date of adoption or the lease commencement date. Rent expense for the operating lease is recognized on a straight-line basis over the lease term. The Company’s lease agreements have lease and non-lease components, which are generally accounted for as a single lease component. Non-lease components include lease operating expenses, which are variable costs under the Company’s current leases. For vehicle leases, the Company accounts for the lease and non-lease components as a single lease component and applies a portfolio approach to effectively account for the operating lease ROU assets and liabilities. Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by a comparison of the carrying amount of an asset or asset group to estimated undiscounted future cash flows expected to be generated by the asset or asset group. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. For the years ended December 31, 2019 , 2018 and 2017 , no such impairment losses have been recorded by the Company. Acquisitions The Company evaluates acquisitions to determine whether the acquisition is a business combination or an acquisition of assets under ASC Topic 805. Business combinations are accounted for using the acquisition method of accounting, whereby assets acquired and liabilities assumed are recorded as of the acquisition date at their respective fair values and excess of the fair value of the consideration transferred over the fair value of the net assets acquired is recorded as goodwill. In an asset acquisition that does not constitute a business, no goodwill is recognized, and the net assets acquired are generally recorded at cost. Significant judgment is required in estimating the fair value of intangible assets and in a determination of whether an acquisition is a business combination or an acquisition of assets. The fair value estimates are based on available historical information and on future expectations and assumptions deemed reasonable by management, but are inherently uncertain. The consolidated financial statements as of and for the years ended December 31, 2019 and December 31, 2017 include the impact of the acquisition of assets from Avizorex and Envisia, respectively (see Note 1 for additional information). Research and Development Costs Research and development costs are charged to expense as incurred and include, but are not limited to: • employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; • expenses incurred under agreements with contract research organizations (“CROs”), contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; • costs associated with any collaboration arrangements, licenses or acquisitions of preclinical molecules, product candidates or technologies; • costs associated with preclinical activities and development activities; • costs associated with regulatory operations; and • depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. No material adjustments to these estimates have been recorded in these consolidated financial statements. Research and development costs also include the cost of IPR&D projects acquired as part of an asset acquisition that have no alternative future use. Milestone payments due to third parties in connection with research and development activities prior to regulatory approval are expensed as incurred, while milestone payments due to third parties upon, or subsequent to, regulatory approval are capitalized and amortized over the estimate useful life. Stock-Based Compensation Stock-based compensation for awards granted to employees and non-employees is measured at grant date, based on the estimated fair value of the award. The Company estimates the fair value of options to purchase common stock and stock appreciation rights (“SARs”) using a Black-Scholes option pricing model. The Black-Scholes option pricing model utilizes assumptions including expected term, volatility, a risk-free interest rate and an expected dividend yield. The Company utilized the guidance set forth in the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin 107, Share-Based Payment (“SAB 107”), to determine the expected term of options, as it does not have sufficient historical exercise and post-vesting termination data to provide a reasonable basis upon which to estimate the expected term of stock options granted to employees. The simplified method utilizes the midpoint between the vesting date and the maximum contractual expiration date as the expected term. Volatility is based on the historical volatility of the Company as well as several public entities that are similar to the Company. The risk-free interest rate is based on the yields of U.S. Treasury securities with maturities similar to the expected term. The Company uses an expected dividend yield of zero as it does not expect to pay cash dividends for the foreseeable future. Upon issuance and at each reporting period, the fair value of each SARs award is estimated using the Black-Scholes option pricing model and is marked to market through stock-based compensation expense. SARs are liability-based awards as they may only be settled in cash. The fair value of restricted stock awards (“RSAs”) and restricted stock units (“RSUs”), including restricted stock awards with non-market performance and service conditions (“PSAs”) are determined based on the fair value of Aerie’s common stock on the date of grant. Compensation expense related to RSAs and RSUs are recognized ratably over the vesting period. As the PSAs have multiple performance conditions, compensation expense is recognized for each vesting tranche over the respective requisite service period of each tranche if and when the Company’s management deems it probable that the performance conditions will be satisfied. Stock-based compensation related to stock options, RSAs, RSUs and PSAs is expensed on a straight-line basis over the relevant vesting period, although the Company may recognize a cumulative true-up adjustment related to PSAs once a condition becomes probable of being satisfied if the related service period had commenced in a prior period. All stock-based compensation expense is recorded between selling, general and administrative, pre-approval commercial manufacturing and research and development costs in the consolidated statements of operations and comprehensive loss based upon the underlying employees’ roles within the Company. The Company accounts for forfeitures as they occur. Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase. The Company’s investments are classified as available-for-sale in accordance with ASC Topic 320, Investments—Debt and Equity Securities . The Company classifies investments available to fund current operations as current assets on its consolidated balance sheets. Investments are classified as long-term assets on the consolidated balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year. Available-for-sale investments in debt securities are recorded at fair value, with unrealized gains or losses included in comprehensive loss on the consolidated statements of operations and comprehensive loss and in accumulated other comprehensive loss on the consolidated balance sheets. Realized gains and losses, interest income earned on the Company’s cash, cash equivalents and investments, and amortization or accretion of discounts and premiums on investments are included within other income (expense), net. Interest income was $3.0 million , $3.4 million and $1.8 million for the years ended December 31, 2019 , 2018 and 2017 , respectively. Realized gains and losses are determined using the specific identification method and are included as a component of other income (expense), net. Realized gains or losses were immaterial for the years ended December 31, 2019 , 2018 and 2017 . The Company reviews investments in debt securities for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. The Company did not recognize any impairments on its investments during the years ended December 31, 2019 , 2018 or 2017 . Fair Value Measurements The Company records certain financial assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements and Disclosures . As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value. • Level 1—Unadjusted quoted prices in active, accessible markets for identical assets or liabilities. • Level 2—Other inputs that are directly or indirectly observable in the marketplace. • Level 3—Unobservable inputs that are supported by little or no market activity. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company’s cash equivalents are carried at fair value according to the fair value hierarchy described above. The Company’s investments were valued utilizing Level 2 inputs and the Convertible Notes were valued utilizing Level 2 inputs as of December 31, 2019. There were no transfers between the different levels of the fair value hierarchy in 2019 or in 2018 . Convertible Notes Transaction The Company separately accounts for the liability and equity components of convertible notes transactions that can be settled in cash by allocating the proceeds from issuance between the liability component and the embedded conversion option in accordance with accounting for convertible debt instruments that may be settled in cash (including partial cash settlement) upon conversion. The value of the equity component is calculated by first measuring the fair value of the liability component, using the interest rate of a similar liability that does not have a conversion feature, as of the issuance date. The difference between the proceeds from the convertible debt issuance and the amount measured as the liability component is recorded as the equity component with a corresponding discount recorded on the debt. The Company recognizes amortization of the resulting discount using the effective interest method as interest expense on the consolidated statements of operations and comprehensive loss. The equity component is not remeasured as long as it continues to meet the conditions for equity classification. The Company allocates issuance costs incurred to the liability and equity components. Issuance costs attributable to the liability component are amortized to expense over the respective term of the convertible notes, and issuance costs attributable to the equity component are netted with the respective equity component in additional paid-in capital. In September 2019, the Company bought capped call options from financial institutions to minimize the impact of potential dilution of Aerie common stock upon conversion of the Convertible Notes. The capped call options meet the definition of a derivative in accordance with ASC 815, Derivatives and Hedging (“ASC 815”), however, qualify for derivative scope exception under ASC 815 for instruments indexed to a company’s own stock. Accordingly, the premiums for the capped call options were recorded as additional paid-in capital on the Company’s consolidated balance sheet as the options are settleable in Aerie common stock at the election of the Company. See Note 10 for additional information. Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss includes changes in stockholders’ equity that are excluded from net income (loss), specifically changes in unrealized gains and losses on the Company’s available-for-sale securities. Income Taxes Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using enacted rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company has provided a full valuation allowance on its deferred tax assets that consist of federal and state net operating losses (“NOLs”), stock-based compensation and tax credits as of December 31, 2019 and 2018 (Note 11 ). The Company reduced its valuation allowance during the year ended December 31, 2017 for federal alternative minimum tax (“AMT”) credit carryforwards that became fully refundable under the Tax Act (defined herein). See Note 11 for additional information. As of December 31, 2019 and 2018 , the Company had no uncertain tax positions. The Company recognizes the impact of an uncertain tax position in the consolidated financial statements only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. The Company did not recognize interest or penalties on uncertain tax positions for the years ended December 31, 2019 , 2018 or 2017 . Adoption of New Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASC Topic 842”). ASC Topic 842 is intended to improve financial reporting of leasing transactions by requiring organizations that lease assets to recognize assets and liabilities for the rights and obligations created by leases that extend more than twelve months on the balance sheet. This accounting update also requires additional disclosures surrounding the amount, timing, and uncertainty of cash flows arising from leases. ASC Topic 842 is effective for financial statements issued for annual and interim periods beginning on January 1, 2019. The Company has elected the optional transition method that provided the option to use the effective date of ASC Topic 842 as the date of initial application on transition. Accordingly, the Company did not adjust comparative periods or make the new required lease disclosures for periods before the effective date of January 1, 2019. There was no cumulative effect adjustment recognized to accumulated deficit upon adoption. As of the date of adoption of the new leasing standards, the Company recognized an operating lease ROU asset of approximately $17.3 million and a corresponding operating lease liability of approximately $17.9 million , which are included in the consolidated balance sheets. The adoption of the new leasing standards did not have a material impact on the consolidated statements of operations and comprehensive loss. The Company elected to utilize the package of practical expedients permitted in ASC Topic 842. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance (i) without reassessing the classification of the operating leases in accordance with ASC Topic 842, (ii) without reassessing whether an existing contract contained a lease and (iii) without reassessing initial direct costs. In addition, the Company elected not to allocate the consideration between lease and non-lease components for its operating leases. The Company also reassessed its lease conclusions for its manufacturing plant in Athlone, Ireland, under ASC Topic 842 since construction was still in progress as of the date of adoption. Upon the reassessment, the Company concluded it was the owner of the leased space for accounting purposes under ASC Topic 842 as of the date of adoption and therefore, maintained its previous build-to-suit lease accounting under the transition guidance of ASC Topic 842. In August 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, which amends ASC 350-40, Internal-Use Software, to include in its scope implementation costs of a cloud computing arrangement that is a service contract. Consequently, the accounting for costs incurred to implement a cloud computing arrangement that is a service arrangement, is aligned with the guidance on capitalizing costs associated with developing or obtaining internal-use software. This ASU is effective for the Company beginning January 1, 2019 and early adoption is permitted. The Company elected to early adopt this standard during the third quarter of 2018, which did not have a material impact on its consolidated financial statements and disclosures. In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), which expands the scope of ASC Topic 718, Compensation—Stock Compensation to include share-based payments issued to non-employees for goods or services. Consequently, the accounting for share-based payments to non-employees and employees will be substantially aligned. This ASU was effective for the Company beginning January 1, 2019. The adoption of ASU 2018-07 did not have a material impact on the Company’s consolidated financial statements and disclosures. In March 2018, the FASB issued ASU 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (“SAB 118”) (“ASU 2018-05”), which adds guidance to clarify the treatment of income taxes based on changes enacted in December 2017 in H.R. 1 (referred to herein as the “Tax Act”). ASU 2018-05 incorporates references in ASC Topic 740 to SAB 118, which was issued in December 2017, to address the application of U.S. GAAP in situations when a registrant may not have the necessary information available in reasonable detail to complete the accounting for certain income tax effects. The guidance became effective immediately upon the enactment of the Tax Act in accordance with U.S. GAAP which requires deferred tax assets and liabilities to be revalued during the period in which new tax legislation is enacted. The Company’s final impact assessment on the consolidated financial statements did not materially change from its initial estimates. In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which clarifies when changes to the terms or conditions of share-based payment awards must be accounted for as modifications. Under ASU 2017-09, an entity will |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition Net product revenues for the year ended December 31, 2019 were generated from sales of Rhopressa ® which was commercially launched in the United States at the end of April 2018, and sales of Rocklatan ® , which was commercially launched in the United States in May 2019. For the year ended December 31, 2019 , three distributors accounted for 36.5% , 33.3% and 28.0% of total revenues, respectively. For the year ended December 31, 2018 , three distributors accounted for 33.9% , 33.3% and 29.7% of total revenues, respectively. The Company commenced generating product revenues related to sales of Rhopressa ® in the second quarter of 2018. Product affordability for the patient drives consumer acceptance, and this is generally managed through coverage by third-party payers, such as government or private healthcare insurers and pharmacy benefit managers (“Third-party Payers”) and such product may be subject to rebates and discounts payable directly to those Third-party Payers. Product revenue is recorded net of trade discounts, allowances, rebates, chargebacks, estimated returns and other incentives, discussed below. These reserves are classified as either reductions of accounts receivable or as current liabilities. Amounts billed or invoiced are included in accounts receivable, net on the consolidated balance sheet. The Company did not have any contract assets (unbilled receivables) as of December 31, 2019 or 2018 , as customer invoicing generally occurs before or at the time of revenue recognition. The Company did not have any contract liabilities as of December 31, 2019 or 2018 , as the Company did not receive payments in advance of fulfilling its performance obligations to its customers. The Company calculates its net product revenue based on the wholesale acquisition cost that the Company charges its Distributors for Rhopressa ® less provisions for (i) trade discounts and allowances, such as discounts for prompt payment and Distributor fees, (ii) estimated rebates to Third-party Payers, estimated payments for Medicare Part D prescription drug program coverage gap (commonly called the “donut hole”), patient co-pay program coupon utilization, chargebacks and other discount programs and (iii) reserves for expected product returns. Provisions for revenue reserves reduced product revenues by $105.9 million and $19.6 million in aggregate for the years ended December 31, 2019 and 2018 , respectively, a significant portion of which related to commercial and Medicare Part D rebates. Trade Discounts and Allowances : The Company generally provides discounts on sales of Rhopressa ® and Rocklatan ® to its distributors for prompt payment and pays fees for distribution services and for certain data that distributors provide to the Company. The Company expects its distributors to earn these discounts and fees, and accordingly deducts the full amount of these discounts and fees from its gross product revenues at the time such revenues are recognized. Rebates, Chargebacks and Other Discounts : The Company contracts with Third-party Payers for coverage and reimbursement of Rhopressa ® and Rocklatan ® . The Company estimates the rebates and chargebacks it expects to be obligated to provide to Third-party Payers and deducts these estimated amounts from its gross product revenue at the time the revenue is recognized. The Company estimates the rebates and chargebacks that it expects to be obligated to provide to Third-party Payers based upon (i) the Company's contracts and negotiations with these Third-party Payers, (ii) estimates regarding the payer mix for Rhopressa ® and Rocklatan ® based on third-party data and utilization, (iii) inventory held by distributors and (iv) estimates of inventory held at the retail channel. Other discounts include the Company’s co-pay assistance coupon programs for commercially-insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to pay associated with product that has been recognized as revenue. Product Returns : The Company estimates the amount of Rhopressa ® and Rocklatan ® that will be returned and deducts these estimated amounts from its gross revenue at the time the revenue is recognized. The Company currently estimates product returns based on historical industry information regarding rates for comparable pharmaceutical products and product portfolios, the estimated remaining shelf life of Rhopressa ® and Rocklatan ® shipped to distributors, and contractual agreements with the Company's distributors intended to limit the amount of inventory they maintain. Reporting from the distributors includes distributor sales and inventory held by distributors, which provides the Company with visibility into the distribution channel to determine when product would be eligible to be returned. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments Cash and cash equivalents and investments as of December 31, 2019 included the following: GROSS GROSS AMORTIZED UNREALIZED UNREALIZED FAIR (in thousands) COST GAINS LOSSES VALUE Cash and cash equivalents: Cash and cash equivalents $ 143,940 $ — $ — $ 143,940 Total cash and cash equivalents $ 143,940 $ — $ — $ 143,940 Investments: Commercial paper (due within 1 year) $ 64,629 $ — $ (7 ) $ 64,622 Corporate bonds (due within 1 year) 60,640 — (76 ) 60,564 U.S. Government and government agencies (due within 1 year) 40,073 — (9 ) 40,064 Total investments $ 165,342 $ — $ (92 ) $ 165,250 Total cash, cash equivalents and investments $ 309,282 $ — $ (92 ) $ 309,190 Cash, cash equivalents and investments as of December 31, 2018 included the following: GROSS GROSS AMORTIZED UNREALIZED UNREALIZED FAIR (in thousands) COST GAINS LOSSES VALUE Cash and cash equivalents: Cash and cash equivalents $ 202,818 $ — $ — $ 202,818 Total cash and cash equivalents $ 202,818 $ — $ — $ 202,818 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following tables summarize the fair value of financial assets and liabilities that are measured at fair value and the classification by level of input within the fair value hierarchy: FAIR VALUE MEASUREMENTS AS OF DECEMBER 31, 2019 (in thousands) LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash and cash equivalents: Cash and cash equivalents $ 133,931 $ 10,009 $ — $ 143,940 Total cash and cash equivalents: $ 133,931 $ 10,009 $ — $ 143,940 Investments: Commercial paper $ — $ 64,622 $ — $ 64,622 Corporate bonds — 60,564 — 60,564 U.S. government and government agencies — 40,064 — 40,064 Total investments $ — $ 165,250 $ — $ 165,250 Total cash, cash equivalents and investments: $ 133,931 $ 175,259 $ — $ 309,190 FAIR VALUE MEASUREMENTS AS OF DECEMBER 31, 2018 (in thousands) LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash and cash equivalents: Cash and cash equivalents $ 202,818 $ — $ — $ 202,818 Total cash and cash equivalents: $ 202,818 $ — $ — $ 202,818 The fair value of the Convertible Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility and is determined by prices observed in market trading. The market for trading of the Convertible Notes is not considered to be an active market and therefore the estimate of fair value is based on Level 2 inputs. The estimated fair value of the Convertible Notes was $372.9 million at December 31, 2019. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consists of the following: DECEMBER 31, (in thousands) 2019 2018 Raw materials $ 1,400 $ 836 Work-in-process 13,414 6,885 Finished goods 6,240 2,391 Total inventory $ 21,054 $ 10,112 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | Property, Plant and Equipment, Net Property, plant and equipment, net consists of the following: (in thousands) DECEMBER 31, 2019 2018 Manufacturing equipment $ 18,073 $ 2,366 Laboratory equipment 7,525 6,038 Furniture and fixtures 1,648 1,815 Software, computer and other equipment 7,772 2,702 Leasehold improvements 29,720 4,072 Construction-in-progress 3,892 49,057 Property, plant and equipment 68,630 66,050 Less: Accumulated depreciation (10,483 ) (5,525 ) Property, plant and equipment, net $ 58,147 $ 60,525 Depreciation expense was $5.1 million , $2.4 million and $1.4 million for the years ended December 31, 2019 , 2018 and 2017 , respectively. Manufacturing Plant Build-Out In the second quarter of 2019, the Company completed the build-out on its own manufacturing plant in Athlone, Ireland, for which it leases approximately 30,000 square feet of interior floor space and as such is not the legal owner of the space. However, in accordance with ASC Topic 842, the Company was deemed to be the owner of the leased space prior to completion of construction. Upon completion, the Company performed a sale-leaseback analysis and accounted for the transaction as a sale. The Company therefore derecognized the build-to-suit asset and the corresponding build-to-suit facility lease obligation of approximately $4.4 million as of the completion date. No gain or loss arose from the derecognition. The Company concurrently recognized an operating lease ROU asset and a corresponding operating lease liability related to the leaseback of the facility. See Note 8 for additional information. The build-to-suit facility lease obligation was approximately $4.5 million as of December 31, 2018. Also, upon completion of the build-out in the second quarter of 2019, amounts previously classified as construction-in-progress related to the manufacturing plant placed into service have been transferred to leasehold improvements and manufacturing equipment and are being amortized in accordance with the Company’s policy. See Note 2 for additional information. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases The Company has operating leases for corporate offices, research and development facilities, and a fleet of vehicles. The properties primarily relate to the Company’s principal executive office and research facility located in Durham, North Carolina, regulatory, commercial support and other administrative activities located in Irvine, California, and clinical, finance and legal operations located in Bedminster, New Jersey. The Durham, North Carolina, facility consists of approximately 61,000 square feet of laboratory and office space under leases that expire between June 2020 and June 2024 and the Irvine, California, location consists of approximately 37,300 square feet of office space under a lease that expires in January 2022. The Company terminated its previous lease and entered into a lease for its new Bedminster, New Jersey, location, which consists of approximately 34,000 square feet of office space under a lease that expires in October 2029. There are also small offices in Malta, Ireland, the United Kingdom and Japan. The Company is leasing approximately 30,000 square feet of interior floor space in Athlone, Ireland, for its manufacturing plant in Athlone, Ireland, which the Company has concluded is an operating lease upon completion of the build-out in the second quarter of 2019. As a result, the Company concurrently recognized an operating lease ROU asset and a corresponding operating lease liability related to the leaseback of the facility of approximately $ 2.4 million upon completion of the build-out. The Company is reasonably certain it will remain in the lease through the end of its lease term in 2037, however, the Company is permitted to terminate the lease as early as September 2027. The Company’s operating leases have remaining lease terms of approximately 1 year to 18 years , some of which include options to extend the leases. Balance sheet information related to leases was as follows: (in thousands) DECEMBER 31, 2019 Operating Leases Operating lease right-of-use assets $ 16,523 Operating lease liabilities $ 5,502 Long-term operating lease liabilities 12,102 Total operating lease liabilities $ 17,604 The cash paid for amounts included in the measurement of lease liabilities was $4.7 million during the year ended December 31, 2019 . The Company’s right-of-use assets obtained in exchange for operating lease obligations was $3.1 million during the year ended December 31, 2019 . DECEMBER 31, 2019 Operating Leases Weighted-average remaining lease terms 8 years Weighted-average discount rate 8 % Maturities of lease liabilities as of December 31, 2019 were as follows: OPERATING (in thousands) LEASES Year Ending December 31, 2020 $ 5,879 2021 4,074 2022 1,925 2023 1,758 Thereafter 11,551 Total undiscounted lease payments 25,187 Less: present value adjustment (7,583 ) Total lease liabilities $ 17,604 Lease expense for the Company’s operating leases was $5.3 million , including variable lease payments of $1.3 million , for the year ended December 31, 2019 , respectively. Under prior lease guidance, minimum lease payments under operating leases were as follows at December 31, 2018 : OPERATING (in thousands) LEASES Year Ending December 31, 2019 $ 4,283 2020 4,855 2021 4,278 2022 1,643 2023 1,438 Thereafter 6,698 Total minimum lease payments $ 23,195 Rent expense for the Company’s operating leases was $ 3.8 million and $2.0 million for the years ended December 31, 2018 and 2017 , respectively. |
Accrued Expenses & Other Curren
Accrued Expenses & Other Current Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses & Other Current Liabilities | Accrued Expenses & Other Current Liabilities Accrued expenses and other current liabilities consist of the following: DECEMBER 31, (in thousands) 2019 2018 Accrued expenses and other current liabilities: Accrued compensation and benefits $ 11,169 $ 10,438 Accrued consulting and professional fees 3,810 3,927 Accrued research and development (1) 8,734 7,503 Accrued revenue reserves (2) 38,450 10,155 Accrued other (3) 3,213 6,358 Total accrued expenses and other current liabilities $ 65,376 $ 38,381 (1) Comprised primarily of accruals related to fees for investigative sites, contract research organizations, contract manufacturing organizations and other service providers that assist in conducting preclinical research studies and clinical trials. Also included are liabilities incurred related to the Avizorex acquisition. (2) Comprised primarily of accruals related to commercial and government rebates as well as returns. (3) Comprised primarily of accruals related to accrued interest as well as other business-related expenses. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Debt Convertible Notes I n September 2019 , the Company issued an aggregate principal amount of $316.25 million of Convertible Notes to qualified institutional buyers pursuant to Rule 144A of the Securities Act of 1933, as amended. The Convertible Notes, governed by an indenture between the Company and a trustee, are senior, unsecured obligations and do not include financial and operating covenants nor any restrictions on the payments of dividends, the incurrence of indebtedness or the issuance or repurchase of securities by Aerie or any of its subsidiaries. Interest on the Convertible Notes is payable semi-annually in cash in arrears at a rate of 1.50% per annum on April 1 and October 1 of each year, beginning on April 1, 2020 . The Convertible Notes will mature on October 1, 2024 unless they are redeemed, repurchased or converted prior to such date. Prior to April 1, 2024, the Convertible Notes will be convertible at the option of holders only during certain periods and upon satisfaction of certain conditions. On and after April 1, 2024, the Convertible Notes will be convertible at the option of the holders any time until the close of business on the second scheduled trading day immediately preceding the maturity date. Upon conversion, the Convertible Notes may be settled in shares of Aerie common stock, cash or a combination, thereof, at the Company's election. The Company intends to settle the principal and interest amounts of the Convertible Notes in cash, and therefore, the Company currently does not expect the conversion to have a dilutive effect on the Company’s earnings per share, as applicable. The Convertible Notes have an initial conversion rate of 40.04 shares of Aerie common stock per $1,000 principal amount of the Convertible Notes, which will be subject to customary anti-dilution adjustments in certain circumstances. This represents an initial effective conversion price of approximately $24.98 per share, which represents a premium of approximately 35% to the $18.50 per share closing price of Aerie common stock on September 4, 2019, the date the Company priced the offering. The Company may redeem all or any portion of the Convertible Notes, at its option, on or after October 3, 2022, at a cash redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price of Aerie common stock exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately before the date the Company provides written notice of redemption; and the trading day immediately before the notice is sent. Holders of Convertible Notes may require the Company to repurchase their Convertible Notes upon the occurrence of certain events that constitute a fundamental change under the indenture governing the Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount thereof, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. During the year ended December 31, 2019 , the conditions allowing holders of the Convertible Notes to elect to convert had not been met. As of December 31, 2019 , the if-converted value of the Convertible Notes did not exceed the principal amount of the Convertible Notes. In connection with the issuance of the Convertible Notes, the Company incurred debt issuance costs of $9.2 million for the year ended December 31, 2019 . In accordance with ASC Topic 470, Debt , these costs were allocated to debt and equity components in proportion to the allocation of proceeds. Issuance costs of $5.5 million were recorded as debt issuance costs in the net carrying value of Convertible Notes. The debt issuance costs are amortized on an effective interest basis over the term of the Convertible Notes. The remaining issuance costs of $3.7 million were recorded as additional paid-in capital, net with the equity component and such amounts are not subject to amortization. The following table summarizes the carrying value of the Convertible Notes as of December 31, 2019 : (in thousands) DECEMBER 31, 2019 Gross proceeds $ 316,250 Unamortized debt discount and issuance costs (127,599 ) Carrying value $ 188,651 The estimated fair value of the liability component of the Convertible Notes at the time of issuance was $187.9 million , and was determined based on a discounted cash flow analysis and a binomial lattice model. The valuation required the use of Level 3 unobservable inputs and subjective assumptions, including but not limited to the stock price volatility and bond yield. The equity component of the Convertible Notes was recognized at issuance and represents the difference between the principal amount of the Convertible Notes and the fair value of the liability component of the Convertible Notes at issuance. The equity component was approximately $128.4 million at the time of issuance and its fair value is not remeasured as long as it continues to meet the conditions for equity classification. Separately, the Company entered into privately negotiated capped call options with financial institutions. The capped call options cover, subject to customary anti-dilution adjustments, the number of shares of Aerie common stock that initially underlie the Convertible Notes. The cap price of the capped call options is $37.00 per share of Aerie common stock, representing a premium of 100% above the closing price of $18.50 per share of Aerie common stock on September 4, 2019, and is subject to certain adjustments under the terms of the capped call options. The capped call options are generally intended to reduce or offset potential dilution to Aerie common stock upon conversion of the Convertible Notes with such reduction and/ or offset, as the case may be, subject to a cap based on the cap price. The Company paid a total of $32.9 million in premiums for the capped call options, which was recorded as additional paid-in capital, using a portion of the gross proceeds from the issuance and sale of the Convertible Notes. The capped call options are excluded from diluted earnings per share because the impact would be anti-dilutive. Interest expense related to the Convertible Notes, including stated interest and amortization of debt discount and issuance costs, was $7.7 million for the year ended December 31, 2019 . Conversion of 2014 Convertible Notes On July 23, 2018, Aerie entered into an Exchange and Termination Agreement (the “Exchange and Termination Agreement”) with Deerfield Private Design Fund III, L.P., Deerfield Partners, L.P. and Deerfield Special Situations Fund, L.P. (collectively, the “Holders”). Pursuant to the Exchange and Termination Agreement, (i) the Holders converted the entire outstanding principal amount of the 2014 Convertible Notes into 5,040,323 shares of Aerie common stock (the “Conversion Shares”) in accordance with the terms of the 2014 Convertible Notes, which was recognized in stockholders’ equity, (ii) Aerie issued the Conversion Shares, and (iii) Aerie paid accrued and unpaid interest on the Convertible Notes through July 23, 2018. In addition, as mutually agreed to with the Holders in order to complete the conversion on the date of the Exchange and Termination Agreement, Aerie issued an additional 329,124 shares of Aerie common stock (the “Additional Shares”) to the Holders. Aerie expensed the value of the Additional Shares in the amount of $24.1 million to other expense during the year ended December 31, 2018 . Credit Facility In September 2019, the Company terminated its $200 million credit facility with certain entities affiliated with Deerfield Management Company L.P. (“Deerfield”) pursuant to which $100 million of delayed draw term loan commitments were provided by Deerfield in July 2018 (the “July 2018 tranche”) and $100 million of delayed draw term loan commitments were provided by Deerfield in May 2019 (the “May 2019 tranche”). Upon termination, the Company paid aggregate fees of $6.5 million to Deerfield in respect of the fee on undrawn amounts and the exit fee for each of the July 2018 tranche and May 2019 tranche. No funds were drawn under either tranche at the time of termination. Interest expense was $15.3 million for the year ended December 31, 2019 , and included amortization of debt discount and issuance costs related to the Convertible Notes and issuance costs and fees related to the credit facility. Interest expense was $2.5 million for the year ended December 31, 2018 , and included amortization of debt discount and issuance costs related to the 2014 Convertible Notes (as defined below) through the date of conversion, as well as issuance costs and fees related to the July 2018 tranche of the credit facility. In July 2018, the entire outstanding principal amount of senior secured convertible notes (the “2014 Convertible Notes”) was converted into shares of Aerie common stock. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The provision for income taxes is based on net loss before income taxes as follows: DECEMBER 31, (in thousands) 2019 2018 2017 Net loss before income taxes: United States $ (153,620 ) $ (203,230 ) $ (133,113 ) Non-U.S. (46,051 ) (29,336 ) (13,750 ) Net loss before income taxes $ (199,671 ) $ (232,566 ) $ (146,863 ) The components of the provision for income taxes are as follows: DECEMBER 31, (in thousands, except percentages) 2019 2018 2017 Provision for income taxes: Current: United States $ (90 ) $ 3 $ (24 ) Non-U.S. — — — Total $ (90 ) $ 3 $ (24 ) Deferred: United States $ — $ — $ (1,734 ) Non-U.S. — — — Total — — (1,734 ) Provision for income taxes $ (90 ) $ 3 $ (1,758 ) Effective tax rate 0.05 % — % 1.20 % Significant components of the Company’s net deferred income tax assets as of December 31, 2019 and 2018 consist of the following: DECEMBER 31, (in thousands) 2019 2018 Net deferred tax assets: Net operating loss carryforwards $ 142,991 $ 112,375 Stock-based compensation 22,785 17,734 U.S. tax credit carryforwards 10,980 5,996 Envisia asset acquisition 5,476 5,888 Basis difference in intangibles 7,625 — Convertible Notes (22,822 ) — Other assets 5,154 2,857 Other liabilities (1,867 ) (1,535 ) Valuation allowance (170,322 ) (143,315 ) Total net deferred income taxes $ — $ — A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 31, 2019 , 2018 and 2017 is as follows: DECEMBER 31, 2019 2018 2017 U.S. federal tax rate 21.00 % 21.00 % 35.00 % Impact of federal tax legislation — % — % 25.82 % State income taxes, net of federal benefit 4.97 % 4.56 % 7.71 % Non-taxable foreign loss (4.44 )% 0.09 % (0.51 )% Stock-based compensation (1.47 )% 1.97 % (0.02 )% Other 0.98 % (1.13 )% (2.19 )% Change in valuation allowance (20.99 )% (26.49 )% (64.61 )% Effective tax rate 0.05 % — % 1.20 % The U.S. Tax Cuts and Jobs Act (the “Tax Act”), enacted on December 22, 2017, introduced significant changes to U.S. income tax law, including, among other things, reducing the U.S. statutory tax rate from 35% to 21% beginning in 2018. Under U.S. GAAP, deferred tax assets and liabilities are required to be revalued during the period in which the new tax legislation is enacted. Therefore, the deferred tax assets and liabilities were remeasured as of December 31, 2017, resulting in a reduction of the deferred tax asset balance and corresponding valuation allowance of $34.2 million due to the enacted changes in tax rate. The Tax Act also repealed the corporate AMT for tax years beginning after December 31,2017, and provides that existing AMT credit carryovers are refundable in tax years beginning after December 31, 2017. In March 2019, the IRS issued new guidance related to sequestration on the AMT tax credits. For taxable years beginning after December 31, 2017, refund payments and refund offset transactions due to refundable minimum tax credits will not be reduced due to federal sequestration. The Company has approximately $1.1 million of remaining AMT credit carryovers that are expected to be fully refunded between 2020 and 2022, of which $0.7 million is recorded as a current receivable with the remainder recorded as a non-current receivable within other assets on the consolidated balance sheet as of December 31, 2019. The Act includes certain anti-deferral and anti-base erosion provisions, including a new minimum tax on global intangible low-taxed income (“GILTI”). The Act subjects the Company to current tax on GILTI of its controlled foreign corporations. Due to current year negative tested income for the Company’s foreign subsidiaries, the Company was not subject to GILTI in 2018 or 2019. At December 31, 2019 , the Company had federal and state NOL carryforwards of approximately $495.6 million and $510.3 million , respectively. If not utilized, federal NOLs that arose prior to 2018 and state NOLs will begin to expire at various dates beginning in 2031 and 2024 , respectively. Federal NOLs that arose on or after January 1, 2018 can be carried forward indefinitely against future income, but can only be used to offset a maximum of 80% of the Company’s federal taxable income in any year. As of December 31, 2019 , the Company also had foreign NOL carryforwards of $68.1 million , which are available solely to offset taxable income of its foreign subsidiaries, subject to any applicable limitations under foreign law. Federal NOLs and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three -year period in excess of 50% , as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. Management assesses the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit use of the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred over the three-year period ended December 31, 2019. Such objective evidence limits the ability to consider other subjective evidence, such as projections for future growth. On the basis of this evaluation, as of December 31, 2019, the Company maintains a valuation allowance on all of its deferred tax assets as of December 31, 2019 . The amount of deferred tax asset considered realizable, however, could be adjusted if objective negative evidence in the form of cumulative losses is no longer present and additional weight is given to other subjective evidence such as projections for growth. As of December 31, 2019 , 2018 , 2017 and 2016 , the Company had a valuation allowance of $170.3 million , $143.3 million , $83.4 million and $56.7 million , respectively. The increase in valuation allowance in 2019 and 2018 of $27.0 million and $59.9 million , respectively, was primarily due to the increase in NOL carryforwards. The increase in valuation allowance in 2017 of $26.7 million was primarily due to the increase in NOL carryforwards, offset by a reduction of the valuation allowance due to the enacted changes in tax rate and federal AMT credit carryforwards, which became fully refundable due to the Tax Act. The Company does not have any unrecognized tax benefits as of December 31, 2019. The Company is subject to taxation in the United States, Ireland and Malta. As of December 31, 2019, tax years ended December 31, 2015 through December 31, 2018 are open under the statute of limitations and subject to tax examinations. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the IRS, state, or non-U.S. tax authorities to the extent utilized in a future period. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity I n September 2019 , the Company issued an aggregate principal amount of $316.25 million of Convertible Notes, of which the equity component was approximately $128.4 million at the time of issuance. Separately, the Company entered into privately negotiated capped call options and paid $32.9 million in premiums. Refer to Note 10 for further information regarding the Convertible Notes. During the year ended December 31, 2018, the Company received net proceeds of approximately $136.4 million through the issue and sale of Aerie’s common stock pursuant to an “at-the-market” sales agreements (“ATMs”) that commenced in December 2017 and pursuant to an underwriting agreement, dated January 23, 2018, relating to the registered public offering of approximately 1.3 million shares of Aerie’s common stock. During the year ended December 31, 2017, Aerie issued and sold approximately 1.1 million shares of common stock under ATMs entered into in May 2017 and December 2017, and received net proceeds of approximately $61.1 million , after deducting fees and expenses. The Company also entered into an underwriting agreement, dated May 25, 2017, relating to the registered public offering of approximately 1.4 million shares of Aerie’s common stock at a price to the public of $53.75 per share, and received net proceeds of approximately $72.7 million , after deducting fees and expenses. Holders of common stock are entitled to dividends when and if declared by Aerie’s Board of Directors subject to prior rights of the holders of any preferred stock. The holder of each share of common stock is entitled to one vote. Warrants The Company had 4,500 underlying shares of warrants outstanding as of December 31, 2019 , which are all currently exercisable at $5.00 per share and expire in August 2020. As of December 31, 2019 and 2018 , all outstanding warrants are classified as equity and are recorded within additional paid-in capital on the consolidated balance sheets. In the fourth quarter of 2019, 298,481 |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation Stock-based compensation expense for options granted, RSAs, PSAs, RSUs, SARs and stock purchase rights are reflected in the consolidated statements of operations and comprehensive loss as follows: YEAR ENDED DECEMBER 31, (in thousands) 2019 2018 2017 Selling, general and administrative $ 30,463 $ 26,432 $ 18,613 Pre-approval commercial manufacturing 3,634 2,622 1,359 Research and development 10,996 9,674 6,106 Total $ 45,093 $ 38,728 $ 26,078 As of December 31, 2019 , the Company had $72.3 million of unrecognized compensation expense related to options outstanding under its equity plans. This expense is expected to be recognized over a weighted average period of 2.6 years as of December 31, 2019 . As of December 31, 2019 , the Company had $22.8 million of unrecognized compensation expense, related to unvested RSAs, including PSAs. This cost is expected to be recognized over a weighted average period of 2.7 years as of December 31, 2019 . Equity Plans The Company maintains three equity compensation plans, the 2005 Aerie Pharmaceutical Stock Plan (the “2005 Plan”), the 2013 Omnibus Incentive Plan (the “2013 Equity Plan”), which was amended and restated as the Aerie Pharmaceuticals, Inc. Second Amended and Restated Omnibus Incentive Plan (the “Second Amended and Restated Equity Plan”), as described below, and the Aerie Pharmaceuticals, Inc. Inducement Award Plan (the “Inducement Award Plan”), as described below. The 2005 Plan, the Second Amended and Restated Equity Plan and the Inducement Award Plan are referred to collectively as the “Plans.” On October 30, 2013, the effective date of the 2013 Equity Plan, the 2005 Plan was frozen and no additional awards have been or will be made under the 2005 Plan. Any remaining shares available for future grant under the 2005 Plan were allocated to the 2013 Equity Plan. On April 10, 2015, Aerie’s stockholders approved the adoption of the Aerie Pharmaceuticals, Inc. Amended and Restated Omnibus Incentive Plan (“Amended and Restated Equity Plan”) and no additional awards have been or will be made under the 2013 Equity Plan. Any remaining shares available under the 2013 Equity Plan were allocated to the Amended and Restated Equity Plan. On June 7, 2018, Aerie’s stockholders approved the adoption of the Second Amended and Restated Equity Plan to increase the number of shares issuable under the Plan by 4,500,000 . The Second Amended and Restated Equity Plan provides for the granting of up to 10,229,068 equity awards in respect of common stock of Aerie, including equity awards that were previously available for issuance under the 2013 Equity Plan. On December 7, 2016, Aerie’s Board of Directors approved the Inducement Award Plan which provides for the granting of up to 418,000 equity awards in respect of common stock of Aerie and was subsequently amended during the year ended December 31, 2017 to increase the equity awards that may be issued by an additional 874,500 shares. On December 5, 2019, the Inducement Award Plan was further amended by the Company’s Board of Directors to increase the number of shares issuable under the plan by 100,000 shares. Awards granted under the Inducement Award Plan are intended to qualify as employment inducement awards under NASDAQ Listing Rule 5635(c)(4). Options to Purchase Common Stock Weighted average assumptions utilized in the fair value calculation for options to purchase common stock as of December 31, 2019 , 2018 and 2017 are as follows: YEAR ENDED 2019 2018 2017 Expected term (years) 6.0 6.0 6.0 Expected stock price volatility 74 % 78 % 84 % Risk-free interest rate 1.9 % 2.7 % 2.0 % Dividend yield — % — % — % The following table summarizes the stock option activity under the Plans: NUMBER OF SHARES WEIGHTED AVERAGE EXERCISE PRICE WEIGHTED AGGREGATE (000’s) Options outstanding at December 31, 2018 6,935,119 $ 28.96 Granted 2,252,643 31.37 Exercised (287,148 ) 16.29 Canceled (474,572 ) 46.45 Expired (491 ) 0.41 Options outstanding at December 31, 2019 8,425,551 $ 29.06 6.7 $ 42,107 Options exercisable at December 31, 2019 5,469,307 $ 24.23 5.5 $ 40,598 The weighted-average fair values of all stock options granted for the years ended December 31, 2019 , 2018 and 2017 was $20.70 , $38.38 , and $35.01 , respectively. The aggregate intrinsic value of options exercised for the years ended December 31, 2019 , 2018 and 2017 was $4.2 million , $32.0 million and $8.6 million , respectively. The intrinsic value is calculated as the difference between the fair market value at December 31, 2019 and the exercise price per share of the stock options. The fair market value per share of common stock as of December 31, 2019 was $24.17 . The following table provides additional information about stock options that are outstanding and exercisable at December 31, 2019 : EXERCISE OPTIONS OUTSTANDING WEIGHTED AVERAGE REMAINING CONTRACTUAL LIFE (YEARS) OPTIONS EXERCISABLE $0.20 - $10.00 1,454,195 3.5 1,454,195 $10.01 - $20.00 1,067,692 6.5 855,530 $20.01 - $30.00 2,597,369 6.8 1,558,247 $30.01 - $45.00 1,283,424 7.7 698,592 $45.01 - $55.00 1,233,270 8.3 513,798 $55.01 - $73.10 789,601 8.2 388,945 8,425,551 5,469,307 Restricted Stock Awards The following table summarizes the RSA, including PSAs, activity under the Plans: NUMBER OF SHARES WEIGHTED AVERAGE FAIR VALUE PER SHARE Nonvested RSAs at December 31, 2018 572,706 $ 48.18 Granted 519,167 40.07 Vested (214,276 ) 45.76 Canceled (123,182 ) 49.64 Nonvested RSAs at December 31, 2019 754,415 $ 43.07 The vesting of the RSAs is time and service based with terms of 1 to 4 years. The total fair value of restricted stock vested during the years ended December 31, 2019 , 2018 and 2017 was $9.8 million , $5.1 million and $1.3 million , respectively. During the year ended December 31, 2017, the Company granted 98,817 RSAs with non-market performance conditions that vest upon the satisfaction of certain performance conditions and service conditions. During the year ended December 31, 2019 , vesting for the remaining PSAs was deemed probable to occur. As of December 31, 2019 , 69,171 PSAs were vested. Restricted Stock Units As of September 30, 2019, 43,071 nonvested RSAs were cancelled and replaced with a corresponding number of RSUs. The RSUs were issued with the same vesting provisions as the cancelled RSAs. Accordingly, the 43,071 RSUs outstanding at September 30, 2019 were nonvested. As of December 31, 2019 , the weighted average fair value per RSU was $19.22 , and the associated unrecognized compensation expense totaled $1.9 million . This expense is expected to be recognized over the weighted average period of 2.7 years as of December 31, 2019 . As of December 31, 2019 , 41,811 RSUs were outstanding. Stock Appreciation Rights The following table summarizes the SARs activity under the Plans: NUMBER OF WEIGHTED AVERAGE WEIGHTED AGGREGATE SARs outstanding at December 31, 2018 91,000 $ 53.75 Granted 113,851 33.73 Exercised — — Canceled (41,835 ) 46.21 SARs outstanding at December 31, 2019 163,016 $ 41.70 3.9 $ 25 SARs exercisable at December 31, 2019 18,000 $ 53.68 3.3 $ — Holders of the SARs are entitled under the terms of the Plans to receive cash payments calculated based on the excess of Aerie’s common stock price over the exercise price in their award; consequently, these awards are accounted for as liability-classified awards and the Company measures compensation cost based on their estimated fair value at each reporting date, net of actual forfeitures, if any. Employee Stock Purchase Plan The Company maintains the 2013 Employee Stock Purchase Plan (the “Purchase Plan”) under which substantially all employees may purchase Aerie’s common stock through payroll deductions and lump sum contributions at a price equal to 85% of the lower of the fair market values of the stock as of the beginning or the end of the offering periods. Employees may not purchase more than the fair value equivalent of $25,000 of stock during any calendar year. The Purchase Plan provides for the issuance of up to 645,814 shares of Aerie’s common stock. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Milestone Payments In association with the Avizorex acquisition (see Note 1 ), contingent milestone payments of up to $69.0 million may be due, subject to achievement of certain product regulatory approvals using the IPR&D assets acquired. Further, in association with the Envisia asset acquisition (see Note 1 ), contingent milestone payments of up to $45.0 million may be due, subject to achievement of certain product regulatory approvals using the IPR&D assets acquired, if achieved within the 15 -year milestone period. Lastly, the Collaboration Agreement with DSM (see Note 1 ) includes contingent payments of up to $75 million that may be due to DSM upon the achievement of certain development and regulatory milestones. These contingent milestone payments are recognized only when the contingency is resolved (the milestone is achieved) and the consideration is paid or becomes payable. As of December 31, 2019 , there were no liabilities recorded relating to potential future milestone payments as the achievement of the related milestones were not met and the timing and likelihood of such milestone payments are not known. Litigation |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information Aerie has one operating segment: the discovery, development and commercialization of pharmaceutical products that address unmet medical needs, focusing on open-angle glaucoma, dry eye, retinal diseases and potentially other diseases of the eye. The Company's business is managed by a single management team, which reports to the Chief Executive Officer. The following table presents total long-lived assets by geographic location: DECEMBER 31, (in thousands) 2019 2018 United States $ 9,184 $ 10,393 Ireland 48,963 50,132 Total long-lived assets $ 58,147 $ 60,525 |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | Selected Quarterly Financial Data (Unaudited) The following table presents selected unaudited quarterly financial information for the years ended December 31, 2019 and 2018 . The results for any quarter are not necessarily indicative of future quarterly results and, accordingly, period to period comparisons should not be relied upon as an indication of future performance. FOR THE QUARTER ENDED (in thousands, except per share amounts) DECEMBER 31, SEPTEMBER 30, JUNE 30, MARCH 31, 2019 Total revenues, net $ 24,657 $ 18,544 $ 15,835 $ 10,852 Total costs and expenses $ 74,595 $ 61,871 $ 61,910 $ 59,004 Net loss $ (55,064 ) $ (49,402 ) $ (47,164 ) $ (47,951 ) Net loss per common share—basic and diluted $ (1.21 ) $ (1.09 ) $ (1.04 ) $ (1.06 ) DECEMBER 31, SEPTEMBER 30, JUNE 30, MARCH 31, 2018 Total revenues, net $ 14,456 $ 7,302 $ 2,423 $ — Total costs and expenses $ 66,381 $ 68,640 $ 58,107 $ 40,795 Net loss $ (51,458 ) $ (85,388 ) $ (55,024 ) $ (40,699 ) Net loss per common share—basic and diluted $ (1.14 ) $ (1.96 ) $ (1.40 ) $ (1.05 ) |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Consolidation | The consolidated financial statements include the accounts of Aerie and its wholly-owned subsidiaries. All intercompany accounts, transactions and profits have been eliminated in consolidation. Certain reclassifications have been made to prior year amounts to conform to the current year presentation. |
Use of Estimates | The preparation of 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 and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, acquisitions, stock-based compensation and fair value measurements. Actual results could differ from the Company’s estimates. |
Segment Information | Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment. |
Concentration of Risk | Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents and investments. The Company’s cash and cash equivalents, which include short-term highly liquid investments with original maturities of three months or less, are held at several financial institutions. The Company’s investment policy permits investments in U.S. federal government and federal agency securities, corporate bonds or commercial paper, money market instruments, and certain qualifying money market mutual funds, and places restrictions on credit ratings, maturities, and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments to the extent recorded on the consolidated balance sheet. The Company relies on its third-party manufacturers to produce the active pharmaceutical ingredient (“API”) and final drug product for Rhopressa ® and Rocklatan ® and may rely on third-party manufacturers for its current and future product candidates. In addition to the current contract manufacturers, the Company obtained FDA approval for an additional Rhopressa ® drug product contract manufacturer in the first quarter of 2019, which began to supply commercial product in the second quarter of 2019. Further, the Company has obtained FDA approval for an additional API contract manufacturer, which began to supply commercial API in the second quarter of 2019. The Company has also received approval of an additional Rocklatan ® drug product contract manufacturer in January 2020. In addition, the Company has established its own manufacturing plant in Athlone, Ireland, for future commercial production of Rocklatan ® and Rhopressa ® , if approved, and thereafter, potentially Rhokiinsa ® and, if approved, Roclanda ® . In January 2020, the Company received FDA approval to produce Rocklatan ® at the Athlone plant for commercial distribution in the United States. This approval follows a successful pre-approval inspection of the plant and FDA review of the New Drug Application (“NDA”) Prior Approval Supplement (“PAS”), which added the Athlone manufacturing plant as a drug product manufacturer for Rocklatan ® . The Company expects FDA approval to produce Rhopressa ® at the Athlone plant by the end of 2020. The Company expects to continue to use product sourced from the contract manufacturers in addition to the manufacturing plant in Athlone, Ireland. |
Revenue Recognition | The Company accounts for its revenue transactions under FASB ASC Topic 606, Revenue from Contracts with Customers . In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied. Aerie’s customers include a limited number of national and select regional wholesalers (the “distributors”). These distributors subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue is typically recognized when distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of product to the distributors. The Company evaluates the creditworthiness of each of its distributors to determine whether it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company does not assess whether a contract has a significant financing component if the expectation is such that the period between the transfer of the promised goods to the customer and the receipt of payment will be less than one year. Standard credit terms do not exceed 75 days. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would have been recognized is one year or less or the amount is immaterial. Shipping and handling costs related to the Company’s product sales are included in selling, general and administrative expenses. The Company’s net product revenues through December 31, 2019 were generated through sales of Rhopressa ® , which was commercially launched in the United States at the end of April 2018, and sales of Rocklatan ® , which was commercially launched in the United States in May 2019. Product revenue is recorded net of trade discounts, allowances, commercial and government rebates, co-pay program coupons, chargebacks, U.S. government funding requirements for the coverage gap (commonly called the “donut hole”) portion of the Medicare Part D program and estimated returns and other incentives. These reserves are classified as either reductions of accounts receivable or as current liabilities. The estimates of reserves established for variable consideration reflect current contractual and statutory requirements, known market events and trends, industry data, forecasted customer mix and lagged claims. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net product revenues only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from these estimates. If actual results vary, estimates may be adjusted in the period such change in estimate becomes known, which could have an impact on earnings in the period of adjustment. See Note 3 for additional information. |
Cash Equivalents | The Company’s cash and cash equivalents are held at several financial institutions. The Company considers money market accounts and short-term highly liquid investments with original maturities of three months or less to be cash equivalents. |
Inventories | Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out (“FIFO”) method. The Company analyzes its inventory levels at least quarterly and writes down inventory that is expected to expire prior to being sold, inventory in excess of expected sales requirements and inventory that fails to meet commercial sale specifications, with a corresponding charge to cost of goods sold. The determination of whether inventory costs will be realizable requires estimates by management of future expected inventory requirements based on sales forecasts. If actual net realizable value is less than the estimated amount or if actual market conditions are less favorable than the Company’s projections, additional inventory write-downs may be required. Charges for inventory write-downs are not reversed if it is later determined that the product is saleable. Prior to the date the Company obtains regulatory approval for its product candidates or its manufacturing facilities such as its manufacturing plant in Athlone, Ireland, manufacturing costs related to commercial production are expensed as pre-approval commercial manufacturing expense on the consolidated statements of operations and comprehensive loss. Once regulatory approval is obtained, the Company capitalizes such costs as inventory on the consolidated balance sheets. |
Property, Plant and Equipment, Net | Property, plant and equipment is recorded at historical cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. Construction-in-progress reflects amounts incurred for property, plant or equipment construction or improvements that have not been yet placed in service and are not depreciated or amortized, which primarily relates to the completion of the build-out of the Company’s manufacturing plant in Ireland. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the determination of net loss. Estimated useful lives by major asset category are as follows: Manufacturing equipment 10 years Laboratory equipment 7 years Furniture and fixtures 5 years Software, computer and other equipment 3 years Leasehold improvements Lower of estimated useful life or term of lease |
Leases | The Company determines if an arrangement is a lease at inception. For each lease, the lease term is determined at the commencement date and includes renewal options and termination options when it is reasonably certain that the Company will exercise that option. Operating leases with lease terms greater than one year are included in operating lease right-of-use (“ROU”) assets and current and long-term operating lease liabilities in the Company’s consolidated balance sheets. Operating lease ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term using an estimated rate of interest the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease ROU assets are based on the liability adjusted for any prepaid or deferred rent and lease incentives. The incremental borrowing rate was utilized to discount lease payments over the expected term given that the Company’s operating leases do not provide an implicit rate. The Company estimates the incremental borrowing rate to reflect the profile of secured borrowing over the expected term of the leases based on the information available at the later of the date of adoption or the lease commencement date. Rent expense for the operating lease is recognized on a straight-line basis over the lease term. The Company’s lease agreements have lease and non-lease components, which are generally accounted for as a single lease component. Non-lease components include lease operating expenses, which are variable costs under the Company’s current leases. For vehicle leases, the Company accounts for the lease and non-lease components as a single lease component and applies a portfolio approach to effectively account for the operating lease ROU assets and liabilities. |
Impairment of Long-Lived Assets | The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by a comparison of the carrying amount of an asset or asset group to estimated undiscounted future cash flows expected to be generated by the asset or asset group. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. |
Acquisitions | The Company evaluates acquisitions to determine whether the acquisition is a business combination or an acquisition of assets under ASC Topic 805. Business combinations are accounted for using the acquisition method of accounting, whereby assets acquired and liabilities assumed are recorded as of the acquisition date at their respective fair values and excess of the fair value of the consideration transferred over the fair value of the net assets acquired is recorded as goodwill. In an asset acquisition that does not constitute a business, no goodwill is recognized, and the net assets acquired are generally recorded at cost. Significant judgment is required in estimating the fair value of intangible assets and in a determination of whether an acquisition is a business combination or an acquisition of assets. The fair value estimates are based on available historical information and on future expectations and assumptions deemed reasonable by management, but are inherently uncertain. |
Research and Development Costs | Research and development costs are charged to expense as incurred and include, but are not limited to: • employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; • expenses incurred under agreements with contract research organizations (“CROs”), contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; • costs associated with any collaboration arrangements, licenses or acquisitions of preclinical molecules, product candidates or technologies; • costs associated with preclinical activities and development activities; • costs associated with regulatory operations; and • depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. No material adjustments to these estimates have been recorded in these consolidated financial statements. Research and development costs also include the cost of IPR&D projects acquired as part of an asset acquisition that have no alternative future use. Milestone payments due to third parties in connection with research and development activities prior to regulatory approval are expensed as incurred, while milestone payments due to third parties upon, or subsequent to, regulatory approval are capitalized and amortized over the estimate useful life. |
Stock-Based Compensation | Stock-based compensation for awards granted to employees and non-employees is measured at grant date, based on the estimated fair value of the award. The Company estimates the fair value of options to purchase common stock and stock appreciation rights (“SARs”) using a Black-Scholes option pricing model. The Black-Scholes option pricing model utilizes assumptions including expected term, volatility, a risk-free interest rate and an expected dividend yield. The Company utilized the guidance set forth in the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin 107, Share-Based Payment (“SAB 107”), to determine the expected term of options, as it does not have sufficient historical exercise and post-vesting termination data to provide a reasonable basis upon which to estimate the expected term of stock options granted to employees. The simplified method utilizes the midpoint between the vesting date and the maximum contractual expiration date as the expected term. Volatility is based on the historical volatility of the Company as well as several public entities that are similar to the Company. The risk-free interest rate is based on the yields of U.S. Treasury securities with maturities similar to the expected term. The Company uses an expected dividend yield of zero as it does not expect to pay cash dividends for the foreseeable future. Upon issuance and at each reporting period, the fair value of each SARs award is estimated using the Black-Scholes option pricing model and is marked to market through stock-based compensation expense. SARs are liability-based awards as they may only be settled in cash. The fair value of restricted stock awards (“RSAs”) and restricted stock units (“RSUs”), including restricted stock awards with non-market performance and service conditions (“PSAs”) are determined based on the fair value of Aerie’s common stock on the date of grant. Compensation expense related to RSAs and RSUs are recognized ratably over the vesting period. As the PSAs have multiple performance conditions, compensation expense is recognized for each vesting tranche over the respective requisite service period of each tranche if and when the Company’s management deems it probable that the performance conditions will be satisfied. Stock-based compensation related to stock options, RSAs, RSUs and PSAs is expensed on a straight-line basis over the relevant vesting period, although the Company may recognize a cumulative true-up adjustment related to PSAs once a condition becomes probable of being satisfied if the related service period had commenced in a prior period. All stock-based compensation expense is recorded between selling, general and administrative, pre-approval commercial manufacturing and research and development costs in the consolidated statements of operations and comprehensive loss based upon the underlying employees’ roles within the Company. The Company accounts for forfeitures as they occur. |
Investments | The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase. The Company’s investments are classified as available-for-sale in accordance with ASC Topic 320, Investments—Debt and Equity Securities . The Company classifies investments available to fund current operations as current assets on its consolidated balance sheets. Investments are classified as long-term assets on the consolidated balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year. Available-for-sale investments in debt securities are recorded at fair value, with unrealized gains or losses included in comprehensive loss on the consolidated statements of operations and comprehensive loss and in accumulated other comprehensive loss on the consolidated balance sheets. Realized gains and losses, interest income earned on the Company’s cash, cash equivalents and investments, and amortization or accretion of discounts and premiums on investments are included within other income (expense), net. Interest income was $3.0 million , $3.4 million and $1.8 million for the years ended December 31, 2019 , 2018 and 2017 , respectively. Realized gains and losses are determined using the specific identification method and are included as a component of other income (expense), net. Realized gains or losses were immaterial for the years ended December 31, 2019 , 2018 and 2017 . |
Fair Value Measurements | The Company records certain financial assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements and Disclosures . As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value. • Level 1—Unadjusted quoted prices in active, accessible markets for identical assets or liabilities. • Level 2—Other inputs that are directly or indirectly observable in the marketplace. • Level 3—Unobservable inputs that are supported by little or no market activity. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. |
Convertible Notes Transactions | The Company separately accounts for the liability and equity components of convertible notes transactions that can be settled in cash by allocating the proceeds from issuance between the liability component and the embedded conversion option in accordance with accounting for convertible debt instruments that may be settled in cash (including partial cash settlement) upon conversion. The value of the equity component is calculated by first measuring the fair value of the liability component, using the interest rate of a similar liability that does not have a conversion feature, as of the issuance date. The difference between the proceeds from the convertible debt issuance and the amount measured as the liability component is recorded as the equity component with a corresponding discount recorded on the debt. The Company recognizes amortization of the resulting discount using the effective interest method as interest expense on the consolidated statements of operations and comprehensive loss. The equity component is not remeasured as long as it continues to meet the conditions for equity classification. The Company allocates issuance costs incurred to the liability and equity components. Issuance costs attributable to the liability component are amortized to expense over the respective term of the convertible notes, and issuance costs attributable to the equity component are netted with the respective equity component in additional paid-in capital. In September 2019, the Company bought capped call options from financial institutions to minimize the impact of potential dilution of Aerie common stock upon conversion of the Convertible Notes. The capped call options meet the definition of a derivative in accordance with ASC 815, Derivatives and Hedging |
Comprehensive Loss | Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss includes changes in stockholders’ equity that are excluded from net income (loss), specifically changes in unrealized gains and losses on the Company’s available-for-sale securities. |
Income Taxes | Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using enacted rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company has provided a full valuation allowance on its deferred tax assets that consist of federal and state net operating losses (“NOLs”), stock-based compensation and tax credits as of December 31, 2019 and 2018 (Note 11 ). The Company reduced its valuation allowance during the year ended December 31, 2017 for federal alternative minimum tax (“AMT”) credit carryforwards that became fully refundable under the Tax Act (defined herein). See Note 11 for additional information. As of December 31, 2019 and 2018 |
Adoption of New Accounting Standards and Recently Issued Accounting Standards | In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASC Topic 842”). ASC Topic 842 is intended to improve financial reporting of leasing transactions by requiring organizations that lease assets to recognize assets and liabilities for the rights and obligations created by leases that extend more than twelve months on the balance sheet. This accounting update also requires additional disclosures surrounding the amount, timing, and uncertainty of cash flows arising from leases. ASC Topic 842 is effective for financial statements issued for annual and interim periods beginning on January 1, 2019. The Company has elected the optional transition method that provided the option to use the effective date of ASC Topic 842 as the date of initial application on transition. Accordingly, the Company did not adjust comparative periods or make the new required lease disclosures for periods before the effective date of January 1, 2019. There was no cumulative effect adjustment recognized to accumulated deficit upon adoption. As of the date of adoption of the new leasing standards, the Company recognized an operating lease ROU asset of approximately $17.3 million and a corresponding operating lease liability of approximately $17.9 million , which are included in the consolidated balance sheets. The adoption of the new leasing standards did not have a material impact on the consolidated statements of operations and comprehensive loss. The Company elected to utilize the package of practical expedients permitted in ASC Topic 842. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance (i) without reassessing the classification of the operating leases in accordance with ASC Topic 842, (ii) without reassessing whether an existing contract contained a lease and (iii) without reassessing initial direct costs. In addition, the Company elected not to allocate the consideration between lease and non-lease components for its operating leases. The Company also reassessed its lease conclusions for its manufacturing plant in Athlone, Ireland, under ASC Topic 842 since construction was still in progress as of the date of adoption. Upon the reassessment, the Company concluded it was the owner of the leased space for accounting purposes under ASC Topic 842 as of the date of adoption and therefore, maintained its previous build-to-suit lease accounting under the transition guidance of ASC Topic 842. In August 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, which amends ASC 350-40, Internal-Use Software, to include in its scope implementation costs of a cloud computing arrangement that is a service contract. Consequently, the accounting for costs incurred to implement a cloud computing arrangement that is a service arrangement, is aligned with the guidance on capitalizing costs associated with developing or obtaining internal-use software. This ASU is effective for the Company beginning January 1, 2019 and early adoption is permitted. The Company elected to early adopt this standard during the third quarter of 2018, which did not have a material impact on its consolidated financial statements and disclosures. In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), which expands the scope of ASC Topic 718, Compensation—Stock Compensation to include share-based payments issued to non-employees for goods or services. Consequently, the accounting for share-based payments to non-employees and employees will be substantially aligned. This ASU was effective for the Company beginning January 1, 2019. The adoption of ASU 2018-07 did not have a material impact on the Company’s consolidated financial statements and disclosures. In March 2018, the FASB issued ASU 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (“SAB 118”) (“ASU 2018-05”), which adds guidance to clarify the treatment of income taxes based on changes enacted in December 2017 in H.R. 1 (referred to herein as the “Tax Act”). ASU 2018-05 incorporates references in ASC Topic 740 to SAB 118, which was issued in December 2017, to address the application of U.S. GAAP in situations when a registrant may not have the necessary information available in reasonable detail to complete the accounting for certain income tax effects. The guidance became effective immediately upon the enactment of the Tax Act in accordance with U.S. GAAP which requires deferred tax assets and liabilities to be revalued during the period in which new tax legislation is enacted. The Company’s final impact assessment on the consolidated financial statements did not materially change from its initial estimates. In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which clarifies when changes to the terms or conditions of share-based payment awards must be accounted for as modifications. Under ASU 2017-09, an entity will not apply modification accounting to a share-based payment award if the award’s fair value, vesting conditions and classification as an equity or liability instrument are the same immediately before and after the change. ASU 2017-09 will be applied prospectively to awards modified on or after the adoption date. The guidance became effective for the Company beginning on January 1, 2018. The impact of the adoption of this guidance on its consolidated financial statements would be dependent on future modifications to share-based payment awards, if any. In October 2016, the FASB issued ASU 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory (“ASU 2016-16”), which eliminates the exception to the principle in ASC Topic 740, Income Taxes , that generally requires comprehensive recognition of current and deferred income taxes for all intra-entity sales of assets other than inventory. As a result, a reporting entity would recognize the tax expense from the sale of the asset in the seller’s tax jurisdiction when the transfer occurs, even though the pre-tax effects of that transaction are eliminated in consolidation. This ASU became effective for the Company on January 1, 2018 and was required to be applied on a modified retrospective basis through a cumulative-effect adjustment directly to accumulated deficit as of the beginning of the period of adoption. At December 31, 2017, the Company had $2.1 million of income tax effects deferred from past intercompany transactions that were recorded as prepaid assets within other assets, net, at December 31, 2017 that were adjusted through accumulated deficit as of January 1, 2018. In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”), which provides guidance related to the accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements for financial instruments. The guidance became effective for the Company beginning on January 1, 2018 and prescribes different transition methods for the various provisions. The adoption of ASU 2016-01 did not have a material impact on its consolidated financial statements and disclosures. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). The standard states that an entity should recognize revenue based on the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The FASB subsequently issued amendments to ASU 2014-09 that had the same effective date of January 1, 2018. The Company did not generate any revenue prior to the three months ended June 30, 2018, and therefore the adoption of ASC Topic 606 did not have an impact on the Company’s financial statements for any prior periods or upon adoption. Revenue from sales of Rhopressa ® , as well as any other future revenue arrangements, are and will be recognized under the provisions of ASC Topic 606. In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business . The new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired, or disposed of, is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. The new standard was effective for the Company beginning on January 1, 2018; however, Aerie elected to early adopt this standard as of July 1, 2017. Under this guidance, the October 4, 2017 transaction to acquire assets from Envisia was determined to meet the criteria of an asset acquisition rather than a business combination resulting in a $24.8 million charge to research and development expense on the consolidated statement of operations and comprehensive loss in the three months ended December 31, 2017. See Note 1 for additional information. Recently Issued Accounting Standards In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which simplifies the accounting for income taxes by removing certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new ASU also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates. These changes aim to improve the overall usefulness of disclosures to financial statement users and reduce unnecessary costs to companies when preparing the disclosures. The guidance is effective for the Company beginning on January 1, 2021 and prescribes different transition methods for the various provisions. The Company is currently evaluating the impact of ASU 2019-12 on its consolidated financial statements and disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820-10): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which changes the fair value measurement disclosure requirements of ASC Topic 820, Fair Value Measurements and Disclosures . Under this ASU, certain disclosure requirements for fair value measurements are eliminated, amended or added. These changes aim to improve the overall usefulness of disclosures to financial statement users and reduce unnecessary costs to companies when preparing the disclosures. The guidance is effective for the Company beginning on January 1, 2020 and prescribes different transition methods for the various provisions. The Company does not expect the adoption of ASU 2018-13 to have a material impact on its consolidated financial statements and disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. Currently, U.S. GAAP delays recognition of the full amount of credit losses until the loss is probable of occurring. Under this ASU, the income statement will reflect an entity’s current estimate of all expected credit losses. The measurement of expected credit losses will be based upon historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down of the security. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses (“ASU 2018-19”), which clarifies that receivables from operating leases are accounted for using the lease guidance and not as financial instruments. The guidance is effective for the Company beginning on January 1, 2020, with early adoption permitted beginning on January 1, 2019. The new guidance prescribes different transition methods for the various provisions. The Company does not expect the adoption of ASU 2016-13 or ASU 2018-19 to have a material impact on its consolidated financial statements and disclosures. |
Net Loss per Common Share | Basic net loss per common share (“Basic EPS”) is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration for potentially dilutive securities with the exception of warrants for common stock with a $0.05 exercise price, which are exercisable for nominal consideration and are therefore included in the calculation of the weighted-average number of shares of common stock as common stock equivalents. Diluted net loss per share (“Diluted EPS”) gives effect to all dilutive potential shares of common stock outstanding during this period. For Diluted EPS, net loss used in calculating Basic EPS may be adjusted for certain items related to the dilutive securities. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives | Estimated useful lives by major asset category are as follows: Manufacturing equipment 10 years Laboratory equipment 7 years Furniture and fixtures 5 years Software, computer and other equipment 3 years Leasehold improvements Lower of estimated useful life or term of lease Property, plant and equipment, net consists of the following: (in thousands) DECEMBER 31, 2019 2018 Manufacturing equipment $ 18,073 $ 2,366 Laboratory equipment 7,525 6,038 Furniture and fixtures 1,648 1,815 Software, computer and other equipment 7,772 2,702 Leasehold improvements 29,720 4,072 Construction-in-progress 3,892 49,057 Property, plant and equipment 68,630 66,050 Less: Accumulated depreciation (10,483 ) (5,525 ) Property, plant and equipment, net $ 58,147 $ 60,525 |
Schedule of Computation of Diluted EPS | The potential common stock equivalents that have been excluded from the computation of Diluted EPS consist of the following: DECEMBER 31, 2019 2018 2017 2014 Convertible Notes — — 5,040,323 Outstanding stock options 8,425,551 6,935,119 6,457,343 Stock purchase warrants 4,500 154,500 157,500 Nonvested restricted stock awards 754,415 572,706 447,049 Nonvested restricted stock units 41,811 — — Total 9,226,277 7,662,325 12,102,215 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents and Investments | Cash and cash equivalents and investments as of December 31, 2019 included the following: GROSS GROSS AMORTIZED UNREALIZED UNREALIZED FAIR (in thousands) COST GAINS LOSSES VALUE Cash and cash equivalents: Cash and cash equivalents $ 143,940 $ — $ — $ 143,940 Total cash and cash equivalents $ 143,940 $ — $ — $ 143,940 Investments: Commercial paper (due within 1 year) $ 64,629 $ — $ (7 ) $ 64,622 Corporate bonds (due within 1 year) 60,640 — (76 ) 60,564 U.S. Government and government agencies (due within 1 year) 40,073 — (9 ) 40,064 Total investments $ 165,342 $ — $ (92 ) $ 165,250 Total cash, cash equivalents and investments $ 309,282 $ — $ (92 ) $ 309,190 Cash, cash equivalents and investments as of December 31, 2018 included the following: GROSS GROSS AMORTIZED UNREALIZED UNREALIZED FAIR (in thousands) COST GAINS LOSSES VALUE Cash and cash equivalents: Cash and cash equivalents $ 202,818 $ — $ — $ 202,818 Total cash and cash equivalents $ 202,818 $ — $ — $ 202,818 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | The following tables summarize the fair value of financial assets and liabilities that are measured at fair value and the classification by level of input within the fair value hierarchy: FAIR VALUE MEASUREMENTS AS OF DECEMBER 31, 2019 (in thousands) LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash and cash equivalents: Cash and cash equivalents $ 133,931 $ 10,009 $ — $ 143,940 Total cash and cash equivalents: $ 133,931 $ 10,009 $ — $ 143,940 Investments: Commercial paper $ — $ 64,622 $ — $ 64,622 Corporate bonds — 60,564 — 60,564 U.S. government and government agencies — 40,064 — 40,064 Total investments $ — $ 165,250 $ — $ 165,250 Total cash, cash equivalents and investments: $ 133,931 $ 175,259 $ — $ 309,190 FAIR VALUE MEASUREMENTS AS OF DECEMBER 31, 2018 (in thousands) LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash and cash equivalents: Cash and cash equivalents $ 202,818 $ — $ — $ 202,818 Total cash and cash equivalents: $ 202,818 $ — $ — $ 202,818 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following: DECEMBER 31, (in thousands) 2019 2018 Raw materials $ 1,400 $ 836 Work-in-process 13,414 6,885 Finished goods 6,240 2,391 Total inventory $ 21,054 $ 10,112 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment, Net | Estimated useful lives by major asset category are as follows: Manufacturing equipment 10 years Laboratory equipment 7 years Furniture and fixtures 5 years Software, computer and other equipment 3 years Leasehold improvements Lower of estimated useful life or term of lease Property, plant and equipment, net consists of the following: (in thousands) DECEMBER 31, 2019 2018 Manufacturing equipment $ 18,073 $ 2,366 Laboratory equipment 7,525 6,038 Furniture and fixtures 1,648 1,815 Software, computer and other equipment 7,772 2,702 Leasehold improvements 29,720 4,072 Construction-in-progress 3,892 49,057 Property, plant and equipment 68,630 66,050 Less: Accumulated depreciation (10,483 ) (5,525 ) Property, plant and equipment, net $ 58,147 $ 60,525 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of Operating Lease Assets and Liabilities | Balance sheet information related to leases was as follows: (in thousands) DECEMBER 31, 2019 Operating Leases Operating lease right-of-use assets $ 16,523 Operating lease liabilities $ 5,502 Long-term operating lease liabilities 12,102 Total operating lease liabilities $ 17,604 |
Schedule of Weighted Average Lease Term | he Company’s right-of-use assets obtained in exchange for operating lease obligations was $3.1 million during the year ended December 31, 2019 . DECEMBER 31, 2019 Operating Leases Weighted-average remaining lease terms 8 years Weighted-average discount rate 8 % |
Lessee, Operating Lease, Liability, Maturity | Maturities of lease liabilities as of December 31, 2019 were as follows: OPERATING (in thousands) LEASES Year Ending December 31, 2020 $ 5,879 2021 4,074 2022 1,925 2023 1,758 Thereafter 11,551 Total undiscounted lease payments 25,187 Less: present value adjustment (7,583 ) Total lease liabilities $ 17,604 |
Schedule of Future Minimum Rental Payments for Operating Leases | Under prior lease guidance, minimum lease payments under operating leases were as follows at December 31, 2018 : OPERATING (in thousands) LEASES Year Ending December 31, 2019 $ 4,283 2020 4,855 2021 4,278 2022 1,643 2023 1,438 Thereafter 6,698 Total minimum lease payments $ 23,195 |
Accrued Expenses & Other Curr_2
Accrued Expenses & Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses & Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: DECEMBER 31, (in thousands) 2019 2018 Accrued expenses and other current liabilities: Accrued compensation and benefits $ 11,169 $ 10,438 Accrued consulting and professional fees 3,810 3,927 Accrued research and development (1) 8,734 7,503 Accrued revenue reserves (2) 38,450 10,155 Accrued other (3) 3,213 6,358 Total accrued expenses and other current liabilities $ 65,376 $ 38,381 (1) Comprised primarily of accruals related to fees for investigative sites, contract research organizations, contract manufacturing organizations and other service providers that assist in conducting preclinical research studies and clinical trials. Also included are liabilities incurred related to the Avizorex acquisition. (2) Comprised primarily of accruals related to commercial and government rebates as well as returns. (3) Comprised primarily of accruals related to accrued interest as well as other business-related expenses. |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Debt | The following table summarizes the carrying value of the Convertible Notes as of December 31, 2019 : (in thousands) DECEMBER 31, 2019 Gross proceeds $ 316,250 Unamortized debt discount and issuance costs (127,599 ) Carrying value $ 188,651 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Components of Provision for Income Taxes | The provision for income taxes is based on net loss before income taxes as follows: DECEMBER 31, (in thousands) 2019 2018 2017 Net loss before income taxes: United States $ (153,620 ) $ (203,230 ) $ (133,113 ) Non-U.S. (46,051 ) (29,336 ) (13,750 ) Net loss before income taxes $ (199,671 ) $ (232,566 ) $ (146,863 ) The components of the provision for income taxes are as follows: DECEMBER 31, (in thousands, except percentages) 2019 2018 2017 Provision for income taxes: Current: United States $ (90 ) $ 3 $ (24 ) Non-U.S. — — — Total $ (90 ) $ 3 $ (24 ) Deferred: United States $ — $ — $ (1,734 ) Non-U.S. — — — Total — — (1,734 ) Provision for income taxes $ (90 ) $ 3 $ (1,758 ) Effective tax rate 0.05 % — % 1.20 % |
Summary of Significant Components of Company's Net Deferred Income Tax Assets | Significant components of the Company’s net deferred income tax assets as of December 31, 2019 and 2018 consist of the following: DECEMBER 31, (in thousands) 2019 2018 Net deferred tax assets: Net operating loss carryforwards $ 142,991 $ 112,375 Stock-based compensation 22,785 17,734 U.S. tax credit carryforwards 10,980 5,996 Envisia asset acquisition 5,476 5,888 Basis difference in intangibles 7,625 — Convertible Notes (22,822 ) — Other assets 5,154 2,857 Other liabilities (1,867 ) (1,535 ) Valuation allowance (170,322 ) (143,315 ) Total net deferred income taxes $ — $ — |
Reconciliation of U.S. Statutory Rate and Effective Tax Rate | A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 31, 2019 , 2018 and 2017 is as follows: DECEMBER 31, 2019 2018 2017 U.S. federal tax rate 21.00 % 21.00 % 35.00 % Impact of federal tax legislation — % — % 25.82 % State income taxes, net of federal benefit 4.97 % 4.56 % 7.71 % Non-taxable foreign loss (4.44 )% 0.09 % (0.51 )% Stock-based compensation (1.47 )% 1.97 % (0.02 )% Other 0.98 % (1.13 )% (2.19 )% Change in valuation allowance (20.99 )% (26.49 )% (64.61 )% Effective tax rate 0.05 % — % 1.20 % |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense for options granted, RSAs, PSAs, RSUs, SARs and stock purchase rights are reflected in the consolidated statements of operations and comprehensive loss as follows: YEAR ENDED DECEMBER 31, (in thousands) 2019 2018 2017 Selling, general and administrative $ 30,463 $ 26,432 $ 18,613 Pre-approval commercial manufacturing 3,634 2,622 1,359 Research and development 10,996 9,674 6,106 Total $ 45,093 $ 38,728 $ 26,078 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions | Weighted average assumptions utilized in the fair value calculation for options to purchase common stock as of December 31, 2019 , 2018 and 2017 are as follows: YEAR ENDED 2019 2018 2017 Expected term (years) 6.0 6.0 6.0 Expected stock price volatility 74 % 78 % 84 % Risk-free interest rate 1.9 % 2.7 % 2.0 % Dividend yield — % — % — % |
Schedule of Stock Options Activity | The following table summarizes the stock option activity under the Plans: NUMBER OF SHARES WEIGHTED AVERAGE EXERCISE PRICE WEIGHTED AGGREGATE (000’s) Options outstanding at December 31, 2018 6,935,119 $ 28.96 Granted 2,252,643 31.37 Exercised (287,148 ) 16.29 Canceled (474,572 ) 46.45 Expired (491 ) 0.41 Options outstanding at December 31, 2019 8,425,551 $ 29.06 6.7 $ 42,107 Options exercisable at December 31, 2019 5,469,307 $ 24.23 5.5 $ 40,598 |
Schedule of Stock Options Outstanding and Exercisable Option Plans | The following table provides additional information about stock options that are outstanding and exercisable at December 31, 2019 : EXERCISE OPTIONS OUTSTANDING WEIGHTED AVERAGE REMAINING CONTRACTUAL LIFE (YEARS) OPTIONS EXERCISABLE $0.20 - $10.00 1,454,195 3.5 1,454,195 $10.01 - $20.00 1,067,692 6.5 855,530 $20.01 - $30.00 2,597,369 6.8 1,558,247 $30.01 - $45.00 1,283,424 7.7 698,592 $45.01 - $55.00 1,233,270 8.3 513,798 $55.01 - $73.10 789,601 8.2 388,945 8,425,551 5,469,307 |
Schedule of Share-based Compensation, Restricted Stock and Restricted Stock Units Activity | The following table summarizes the RSA, including PSAs, activity under the Plans: NUMBER OF SHARES WEIGHTED AVERAGE FAIR VALUE PER SHARE Nonvested RSAs at December 31, 2018 572,706 $ 48.18 Granted 519,167 40.07 Vested (214,276 ) 45.76 Canceled (123,182 ) 49.64 Nonvested RSAs at December 31, 2019 754,415 $ 43.07 |
Schedule of Stock Appreciation Rights | The following table summarizes the SARs activity under the Plans: NUMBER OF WEIGHTED AVERAGE WEIGHTED AGGREGATE SARs outstanding at December 31, 2018 91,000 $ 53.75 Granted 113,851 33.73 Exercised — — Canceled (41,835 ) 46.21 SARs outstanding at December 31, 2019 163,016 $ 41.70 3.9 $ 25 SARs exercisable at December 31, 2019 18,000 $ 53.68 3.3 $ — |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Segment Reporting [Abstract] | |
Schedule of Long-Lived Assets by Location | The following table presents total long-lived assets by geographic location: DECEMBER 31, (in thousands) 2019 2018 United States $ 9,184 $ 10,393 Ireland 48,963 50,132 Total long-lived assets $ 58,147 $ 60,525 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Financial Information | The following table presents selected unaudited quarterly financial information for the years ended December 31, 2019 and 2018 . The results for any quarter are not necessarily indicative of future quarterly results and, accordingly, period to period comparisons should not be relied upon as an indication of future performance. FOR THE QUARTER ENDED (in thousands, except per share amounts) DECEMBER 31, SEPTEMBER 30, JUNE 30, MARCH 31, 2019 Total revenues, net $ 24,657 $ 18,544 $ 15,835 $ 10,852 Total costs and expenses $ 74,595 $ 61,871 $ 61,910 $ 59,004 Net loss $ (55,064 ) $ (49,402 ) $ (47,164 ) $ (47,951 ) Net loss per common share—basic and diluted $ (1.21 ) $ (1.09 ) $ (1.04 ) $ (1.06 ) DECEMBER 31, SEPTEMBER 30, JUNE 30, MARCH 31, 2018 Total revenues, net $ 14,456 $ 7,302 $ 2,423 $ — Total costs and expenses $ 66,381 $ 68,640 $ 58,107 $ 40,795 Net loss $ (51,458 ) $ (85,388 ) $ (55,024 ) $ (40,699 ) Net loss per common share—basic and diluted $ (1.14 ) $ (1.96 ) $ (1.40 ) $ (1.05 ) |
The Company (Details)
The Company (Details) | Aug. 01, 2018USD ($) | Nov. 30, 2019USD ($) | Oct. 31, 2017USD ($)shares | Oct. 31, 2017USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2019USD ($)segmentproduct | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2019USD ($) | May 31, 2019USD ($) | Jul. 31, 2018USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Number of operating segments | segment | 1 | |||||||||||
Number U.S. FDA approved products | product | 2 | |||||||||||
Research and development | $ 91,378,000 | $ 86,123,000 | $ 72,078,000 | |||||||||
Delayed Draw Term Loan | Revolving Credit Facility | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Maximum borrowing capacity | $ 200,000,000 | $ 100,000,000 | $ 100,000,000 | |||||||||
Convertible debt | Convertible Senior Notes Due 2024 | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Principal amount | $ 316,250,000 | $ 316,250,000 | ||||||||||
Debt instrument, interest rate percentage | 1.50% | |||||||||||
DSM Collaborative Arrangement | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Research and development | $ 9,600,000 | |||||||||||
Amount paid due to collaboration arrangement | $ 6,000,000 | $ 3,000,000 | ||||||||||
Contingent payments due (up to) | $ 75,000,000 | |||||||||||
DSM Collaborative Arrangement | Scenario, Forecast | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Amount of to be paid due to collaborative agreement | $ 9,000,000 | |||||||||||
Avizorex | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Asset acquisition, consideration transferred | $ 10,200,000 | |||||||||||
Milestone payments contingent upon the achievement of certain approvals | 69,000,000 | |||||||||||
Research and development | $ 10,200,000 | |||||||||||
Envisia | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||||
Milestone payments contingent upon the achievement of certain approvals | $ 45,000,000 | |||||||||||
Upfront cash payment | $ 10,500,000 | |||||||||||
Common stock, shares issued (in shares) | shares | 263,146 | |||||||||||
Common stock value | $ 14,300,000 | |||||||||||
Research and development | $ 24,800,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Details) | Jan. 01, 2018USD ($) | Dec. 31, 2019USD ($)segment$ / shares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) |
Significant Accounting Policies [Line Items] | |||||
Number of operating segments | segment | 1 | ||||
Impairment losses of long lived assets | $ 0 | $ 0 | $ 0 | ||
Recognized impairments on investments | 0 | 0 | 0 | ||
Interest income | 3,000,000 | 3,400,000 | 1,800,000 | ||
Operating lease right-of-use assets | 16,523,000 | ||||
Total lease liabilities | 17,604,000 | ||||
Income tax effect | (90,000) | 3,000 | (1,758,000) | ||
Research and development | $ 91,378,000 | $ 86,123,000 | $ 72,078,000 | ||
Warrants exercise price (in dollars per share) | $ / shares | $ 0.05 | ||||
Accounting Standards Update 2016-02 | |||||
Significant Accounting Policies [Line Items] | |||||
Operating lease right-of-use assets | $ 17,300,000 | ||||
Total lease liabilities | $ 17,900,000 | ||||
Long-term Receivable | Accounting Standards Update 2016-16, Income Tax Effect Deferred From Past Intercompany Transactions | |||||
Significant Accounting Policies [Line Items] | |||||
Income tax effect | $ 2,100,000 |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life (years) | 10 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life (years) | 7 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life (years) | 5 years |
Software, computer and other equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life (years) | 3 years |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Computation of Diluted EPS (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common stock equivalents excluded from the computation of diluted net loss (in shares) | 9,226,277 | 7,662,325 | 12,102,215 |
2014 Convertible Notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common stock equivalents excluded from the computation of diluted net loss (in shares) | 0 | 0 | 5,040,323 |
Outstanding stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common stock equivalents excluded from the computation of diluted net loss (in shares) | 8,425,551 | 6,935,119 | 6,457,343 |
Stock purchase warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common stock equivalents excluded from the computation of diluted net loss (in shares) | 4,500 | 154,500 | 157,500 |
Nonvested restricted stock awards | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common stock equivalents excluded from the computation of diluted net loss (in shares) | 754,415 | 572,706 | 447,049 |
Nonvested restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential common stock equivalents excluded from the computation of diluted net loss (in shares) | 41,811 | 0 | 0 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Provision for revenue reserves to reduce product revenues to product revenues, net | $ 105.9 | $ 19.6 |
Customer Concentration Risk | Sales Revenue, Net | Rhopressa | Distributor One | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 36.50% | 33.90% |
Customer Concentration Risk | Sales Revenue, Net | Rhopressa | Distributor Two | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 33.30% | 33.30% |
Customer Concentration Risk | Sales Revenue, Net | Rhopressa | Distributor Three | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 28.00% | 29.70% |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Cash and cash equivalents: | ||
Amortized cost | $ 143,940 | $ 202,818 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair value | 143,940 | 202,818 |
Investments: | ||
Amortized cost | 165,342 | |
Gross unrealized gains | 0 | |
Gross unrealized losses | (92) | |
Fair value | 165,250 | |
Total cash, cash equivalents and investments, amortized cost | 309,282 | |
Total cash, cash equivalents and investments, fair value | 309,190 | |
Cash and cash equivalents | ||
Cash and cash equivalents: | ||
Amortized cost | 143,940 | 202,818 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair value | 143,940 | $ 202,818 |
Commercial paper (due within 1 year) | ||
Investments: | ||
Amortized cost | 64,629 | |
Gross unrealized gains | 0 | |
Gross unrealized losses | (7) | |
Fair value | 64,622 | |
Corporate bonds (due within 1 year) | ||
Investments: | ||
Amortized cost | 60,640 | |
Gross unrealized gains | 0 | |
Gross unrealized losses | (76) | |
Fair value | 60,564 | |
U.S. Government and government agencies (due within 1 year) | ||
Investments: | ||
Amortized cost | 40,073 | |
Gross unrealized gains | 0 | |
Gross unrealized losses | (9) | |
Fair value | $ 40,064 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 143,940 | $ 202,818 |
Total investments | 165,250 | |
Total cash, cash equivalents and investments: | 309,190 | |
LEVEL 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 133,931 | 202,818 |
Total investments | 0 | |
Total cash, cash equivalents and investments: | 133,931 | |
LEVEL 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 10,009 | 0 |
Total investments | 165,250 | |
Total cash, cash equivalents and investments: | 175,259 | |
LEVEL 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Total investments | 0 | |
Total cash, cash equivalents and investments: | 0 | |
Cash and cash equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 143,940 | 202,818 |
Cash and cash equivalents | LEVEL 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 133,931 | 202,818 |
Cash and cash equivalents | LEVEL 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 10,009 | 0 |
Cash and cash equivalents | LEVEL 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | $ 0 |
Commercial paper (due within 1 year) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 64,622 | |
Commercial paper (due within 1 year) | LEVEL 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 0 | |
Commercial paper (due within 1 year) | LEVEL 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 64,622 | |
Commercial paper (due within 1 year) | LEVEL 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 0 | |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 60,564 | |
Corporate bonds | LEVEL 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 0 | |
Corporate bonds | LEVEL 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 60,564 | |
Corporate bonds | LEVEL 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 0 | |
U.S. government and government agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 40,064 | |
U.S. government and government agencies | LEVEL 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 0 | |
U.S. government and government agencies | LEVEL 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | 40,064 | |
U.S. government and government agencies | LEVEL 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Millions | Dec. 31, 2019USD ($) |
LEVEL 2 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Estimated fair value of the convertible notes | $ 372.9 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,400 | $ 836 |
Work-in-process | 13,414 | 6,885 |
Finished goods | 6,240 | 2,391 |
Total inventory | $ 21,054 | $ 10,112 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 68,630 | $ 66,050 |
Less: Accumulated depreciation | (10,483) | (5,525) |
Property, plant and equipment, net | 58,147 | 60,525 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 18,073 | 2,366 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 7,525 | 6,038 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 1,648 | 1,815 |
Software, computer and other equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 7,772 | 2,702 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 29,720 | 4,072 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 3,892 | $ 49,057 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Details) ft² in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2019USD ($)ft² | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 5,138 | $ 2,442 | $ 1,410 | |
Area of interior floor space | ft² | 30 | |||
Build-to-suit lease obligation derecognized | $ 4,400 | |||
Build-to-suit, long term obligation | $ 4,500 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2019USD ($)ft² | Dec. 31, 2019USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Operating Leased Assets [Line Items] | ||||
Area of interior floor space | ft² | 30,000 | |||
Cash paid for amounts included in the measurement of lease liabilities | $ 4,682 | |||
Operating lease right-of-use assets | 3,100 | |||
Lease expense for operating lease | 5,300 | |||
Variable lease payments for operating lease | $ 1,300 | |||
Operating leases, rent expense | $ 3,800 | $ 2,000 | ||
North Carolina | ||||
Operating Leased Assets [Line Items] | ||||
Area of interior floor space | ft² | 61,000 | |||
Carolina | ||||
Operating Leased Assets [Line Items] | ||||
Area of interior floor space | ft² | 37,300 | |||
New Jersey | ||||
Operating Leased Assets [Line Items] | ||||
Area of interior floor space | ft² | 34,000 | |||
Ireland | ||||
Operating Leased Assets [Line Items] | ||||
Area of interior floor space | ft² | 30,000 | |||
Right-of-use asset and liability upon lease inception | $ 2,400 | |||
Minimum | ||||
Operating Leased Assets [Line Items] | ||||
Term of contract | 1 year | |||
Maximum | ||||
Operating Leased Assets [Line Items] | ||||
Term of contract | 18 years |
Leases - Schedule of Operating
Leases - Schedule of Operating Lease Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating Leases | |
Operating lease right-of-use assets | $ 16,523 |
Operating lease liabilities | 5,502 |
Long-term operating lease liabilities | 12,102 |
Total operating lease liabilities | $ 17,604 |
Leases - Schedule of Cash Flow
Leases - Schedule of Cash Flow Information (Details) | Dec. 31, 2019 |
Operating Leases | |
Weighted-average remaining lease terms | 8 years |
Weighted-average discount rate | 8.00% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Year Ending December 31, | |
2020 | $ 5,879 |
2021 | 4,074 |
2022 | 1,925 |
2023 | 1,758 |
Thereafter | 11,551 |
Total undiscounted lease payments | 25,187 |
Less: present value adjustment | (7,583) |
Total lease liabilities | $ 17,604 |
Leases - Schedule of Minimum Le
Leases - Schedule of Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Year Ending December 31, | |
2019 | $ 4,283 |
2020 | 4,855 |
2021 | 4,278 |
2022 | 1,643 |
2023 | 1,438 |
Thereafter | 6,698 |
Total minimum lease payments | $ 23,195 |
Accrued Expenses & Other Curr_3
Accrued Expenses & Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued expenses and other current liabilities: | ||
Accrued compensation and benefits | $ 11,169 | $ 10,438 |
Accrued consulting and professional fees | 3,810 | 3,927 |
Accrued research and development | 8,734 | 7,503 |
Accrued revenue reserves | 38,450 | 10,155 |
Accrued other | 3,213 | 6,358 |
Total accrued expenses and other current liabilities | $ 65,376 | $ 38,381 |
Debt - Convertible Notes (Detai
Debt - Convertible Notes (Details) | Sep. 04, 2019$ / shares$ / unit | Sep. 30, 2019USD ($)d$ / shares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Debt Instrument [Line Items] | |||||
Debt instrument trading days | d | 20 | ||||
Debt instrument consecutive trading day | d | 30 | ||||
Debt issuance costs related with equity component of convertible debt | $ 0 | $ 0 | $ 403,000 | ||
Premiums for capped call options | $ 32,900,000 | 32,890,000 | |||
Interest expense | 15,300,000 | $ 2,500,000 | |||
Call Option | |||||
Debt Instrument [Line Items] | |||||
Capped price (in dollars per share) | $ / unit | 37 | ||||
Premium of cap price as a percentage of closing price | 100.00% | ||||
Convertible debt | |||||
Debt Instrument [Line Items] | |||||
Interest expense | 7,700,000 | ||||
Convertible debt | Convertible Senior Notes Due 2024 | |||||
Debt Instrument [Line Items] | |||||
Principal amount | $ 316,250,000 | 316,250,000 | |||
Debt instrument, interest rate percentage | 1.50% | ||||
Debt instrument, effective conversion price (in dollars per share) | $ / shares | $ 24.98 | ||||
Stock price trigger, premium on closing price (as a percent) | 35.00% | ||||
Redemption price (as a percent) | 100.00% | 100.00% | |||
Stock price trigger (as a percent) | 130.00% | ||||
Debt issuance costs incurred | 9,200,000 | ||||
Debt issuance costs, net | 5,500,000 | ||||
Debt issuance costs related with equity component of convertible debt | 3,700,000 | ||||
Equity component of convertible debt | $ 128,400,000 | $ 128,400,000 | |||
Convertible debt | Convertible Senior Notes Due 2024 | LEVEL 3 | |||||
Debt Instrument [Line Items] | |||||
Convertible notes fair value of liability component | $ 187,900,000 | ||||
Common Stock | |||||
Debt Instrument [Line Items] | |||||
Closing stock price (in dollars per share) | $ / shares | $ 18.50 | ||||
Common Stock | Convertible debt | Convertible Senior Notes Due 2024 | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, conversion price (in dollars per share) | $ / shares | $ 0.04004 |
Debt - Reconciliation of Conver
Debt - Reconciliation of Convertible Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
Unamortized debt discount and issuance costs | $ (127,599) | |
Carrying value | $ 188,651 | $ 0 |
Debt - 2014 Convertible Notes a
Debt - 2014 Convertible Notes and Credit Facility (Details) - USD ($) | Jul. 23, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2019 | May 31, 2019 | Jul. 31, 2018 |
Debt Instrument [Line Items] | ||||||
Interest expense | $ 15,300,000 | $ 2,500,000 | ||||
Convertible debt | ||||||
Debt Instrument [Line Items] | ||||||
Interest expense | 7,700,000 | |||||
Convertible debt | 2014 Notes | ||||||
Debt Instrument [Line Items] | ||||||
Funds drawn at closing | $ 0 | |||||
Revolving Credit Facility | ||||||
Debt Instrument [Line Items] | ||||||
Fee amount | $ 6,500,000 | |||||
Funds drawn at closing | 0 | |||||
Revolving Credit Facility | Delayed Draw Term Loan | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 200,000,000 | $ 100,000,000 | $ 100,000,000 | |||
Common Stock | 2014 Notes | ||||||
Debt Instrument [Line Items] | ||||||
Conversion of stock (in shares) | 5,040,323 | |||||
Additional shares converted (in shares) | 329,124 | |||||
Induced conversion of convertible debt expense | $ 24,100,000 |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Net loss before income taxes: | |||
United States | $ (153,620) | $ (203,230) | $ (133,113) |
Non-U.S. | (46,051) | (29,336) | (13,750) |
Loss before income taxes | (199,671) | (232,566) | (146,863) |
Current: | |||
United States | (90) | 3 | (24) |
Non-U.S. | 0 | 0 | 0 |
Total | (90) | 3 | (24) |
Deferred: | |||
United States | 0 | 0 | (1,734) |
Non-U.S. | 0 | 0 | 0 |
Total | 0 | 0 | (1,734) |
Provision for income taxes | $ (90) | $ 3 | $ (1,758) |
Effective tax rate (in percentage) | 0.05% | 0.00% | 1.20% |
Income Taxes - Summary of Signi
Income Taxes - Summary of Significant Components of Company's Net Deferred Income Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Net deferred tax assets: | ||||
Net operating loss carryforwards | $ 142,991 | $ 112,375 | ||
Stock-based compensation | 22,785 | 17,734 | ||
U.S. tax credit carryforwards | 10,980 | 5,996 | ||
Envisia asset acquisition | 5,476 | 5,888 | ||
Basis difference in intangibles | 7,625 | 0 | ||
Convertible Notes | (22,822) | 0 | ||
Other assets | 5,154 | 2,857 | ||
Other liabilities | (1,867) | (1,535) | ||
Valuation allowance | (170,322) | (143,315) | $ (83,400) | $ (56,700) |
Total net deferred income taxes | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Statutory Rate and Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal tax rate | 21.00% | 21.00% | 35.00% |
Impact of federal tax legislation | 0.00% | 0.00% | 25.82% |
State income taxes, net of federal benefit | 4.97% | 4.56% | 7.71% |
Non-taxable foreign loss | (4.44%) | 0.09% | (0.51%) |
Stock-based compensation | (1.47%) | 1.97% | (0.02%) |
Other | 0.98% | (1.13%) | (2.19%) |
Change in valuation allowance | (20.99%) | (26.49%) | (64.61%) |
Effective tax rate | 0.05% | 0.00% | 1.20% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Tax Credit Carryforward [Line Items] | ||||
Deferred tax liabilities as a result of TCJA | $ 34,200 | |||
Valuation allowance | $ 170,322 | $ 143,315 | 83,400 | $ 56,700 |
Period of cumulative changes in ownership interests | 3 years | |||
Percentage of cumulative changes in ownership interests | 50.00% | |||
Increase in valuation allowance | $ 27,000 | $ 59,900 | $ 26,700 | |
Federal tax authority | ||||
Tax Credit Carryforward [Line Items] | ||||
Valuation allowance | 1,100 | |||
Net operating loss carry-forwards | 495,600 | |||
Federal tax authority | Current Receivable | ||||
Tax Credit Carryforward [Line Items] | ||||
Valuation allowance | 700 | |||
State tax authority | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carry-forwards | 510,300 | |||
Foreign tax authority | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carry-forwards | $ 68,100 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, shares in Millions | Jan. 23, 2018shares | May 25, 2017USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($)vote | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)shares |
Class of Stock [Line Items] | ||||||
Premiums for capped call options | $ 32,900,000 | $ 32,890,000 | ||||
Proceeds from sale of common stock | $ 0 | $ 135,972,000 | $ 134,215,000 | |||
Number of voting rights | vote | 1 | |||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from sale of common stock | $ 72,700,000 | $ 136,400,000 | $ 61,100,000 | |||
New shares issued under shelf registration (in shares) | shares | 1.3 | 1.4 | ||||
Common stock issued and sold under sales agreement (in shares) | shares | 1.1 | |||||
Price per share issued under underwriting agreement (in dollars per share) | $ / shares | $ 53.75 | |||||
Convertible Senior Notes Due 2024 | Convertible debt | ||||||
Class of Stock [Line Items] | ||||||
Principal amount | 316,250,000 | $ 316,250,000 | ||||
Equity component of convertible debt | $ 128,400,000 | $ 128,400,000 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) | 3 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Warrants exercise price (in dollars per share) | $ / shares | $ 0.05 |
Number of warrants exercised (in shares) | shares | 298,481 |
August 2020 | |
Class of Warrant or Right [Line Items] | |
Number of underlying shares (in shares) | shares | 4,500 |
Warrants exercise price (in dollars per share) | $ / shares | $ 5 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-based Compensation Expense for Options Granted and Restricted Stock as Reflected in the Statement of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 45,093 | $ 38,728 | $ 26,078 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 30,463 | 26,432 | 18,613 |
Pre-approval commercial manufacturing | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 3,634 | 2,622 | 1,359 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 10,996 | $ 9,674 | $ 6,106 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 05, 2019 | Jun. 07, 2018 | Dec. 07, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Weighted average grant date fair value (in dollars per share) | $ 20.70 | $ 38.38 | $ 35.01 | ||||
Aggregate intrinsic value of options exercised | $ 4,200 | $ 32,000 | $ 8,600 | ||||
Estimated fair value of common stock (in dollars per share) | $ 24.17 | ||||||
Employee stock option | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Unrecognized compensation expense | $ 72,300 | ||||||
Compensation cost, weighted average recognition period | 2 years 7 months 6 days | ||||||
Second Amendment and Restated Equity Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity awards (in shares) | 10,229,068 | 4,500,000 | |||||
Inducement Award Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity awards (in shares) | 874,500 | 100,000 | 418,000 | ||||
Minimum | Employee stock option | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based awards, vesting period | 1 year | ||||||
Maximum | Employee stock option | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based awards, vesting period | 4 years | ||||||
Restricted stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation cost, weighted average recognition period | 2 years 8 months 12 days | ||||||
Unrecognized compensation expense | $ 22,800 | ||||||
Fair value of restricted stock vested | $ 9,800 | $ 5,100 | $ 1,300 | ||||
Shares issued (in shares) | 519,167 | ||||||
Vested (in shares) | 214,276 | ||||||
Non-vested shares cancelled and replaced (in shares) | 123,182 | ||||||
Stock-based compensation, non vesting (in shares) | 754,415 | 572,706 | |||||
Weighted average fair value (in dollars per share) | $ 40.07 | ||||||
Restricted Stock With Non-Market Performance Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares issued (in shares) | 98,817 | ||||||
Vested (in shares) | 69,171 | ||||||
Employee stock purchase plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares issued (in shares) | 645,814 | ||||||
Lump sum percentage (equal to) | 85.00% | ||||||
Fair value equivalent of common stock | $ 25 | ||||||
RSUs | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Unrecognized compensation expense | $ 1,900 | ||||||
Compensation cost, weighted average recognition period | 2 years 8 months 12 days | ||||||
Non-vested shares cancelled and replaced (in shares) | 43,071 | ||||||
Stock-based compensation, non vesting (in shares) | 43,071 | 41,811 | |||||
Weighted average fair value (in dollars per share) | $ 19.22 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Key Assumptions Utilized in Fair Value Calculation (Details) - Outstanding stock options | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (years) | 6 years | 6 years | 6 years |
Expected stock price volatility (in percentage) | 74.00% | 78.00% | 84.00% |
Risk-free interest rate (in percentage) | 1.90% | 2.70% | 2.00% |
Dividend yield (in percentage) | 0.00% | 0.00% | 0.00% |
Stock-based Compensation - Sc_2
Stock-based Compensation - Schedule of Stock Options Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
NUMBER OF OPTIONS | |
Options outstanding at beginning of year (in shares) | shares | 6,935,119 |
Granted (in shares) | shares | 2,252,643 |
Exercised (in shares) | shares | (287,148) |
Canceled (in shares) | shares | (474,572) |
Expired (in shares) | shares | (491) |
Options outstanding at end of year (in shares) | shares | 8,425,551 |
Options exercisable at end of year (in shares) | shares | 5,469,307 |
WEIGHTED AVERAGE EXERCISE PRICE | |
Options outstanding at beginning of year, weighted average exercise price (in dollars per share) | $ / shares | $ 28.96 |
Granted (in dollars per share) | $ / shares | 31.37 |
Exercised (in dollars per share) | $ / shares | 16.29 |
Canceled (in dollars per share) | $ / shares | 46.45 |
Expired (in dollars per share) | $ / shares | 0.41 |
Options outstanding at end of year, weighted average exercise price (in dollars per share) | $ / shares | 29.06 |
Options exercisable, weighted average exercise price (in dollars per share) | $ / shares | $ 24.23 |
WEIGHTED AVERAGE REMAINING CONTRACTUAL LIFE (YEARS) | |
Options outstanding (in years) | 6 years 8 months 12 days |
Options exercisable (in years) | 5 years 6 months |
WEIGHTED AVERAGE REMAINING CONTRACTUAL LIFE (YEARS) | |
Options outstanding | $ | $ 42,107 |
Options exercisable | $ | $ 40,598 |
Stock-based Compensation - Sc_3
Stock-based Compensation - Schedule of Stock Options Outstanding and Exercisable Option Plans (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 8,425,551 |
Options exercisable (in shares) | 5,469,307 |
$0.20 - $10.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 1,454,195 |
Options outstanding, weighted average remaining contractual life (in years) | 3 years 6 months |
Options exercisable (in shares) | 1,454,195 |
$10.01 - $20.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 1,067,692 |
Options outstanding, weighted average remaining contractual life (in years) | 6 years 6 months |
Options exercisable (in shares) | 855,530 |
$20.01 - $30.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 2,597,369 |
Options outstanding, weighted average remaining contractual life (in years) | 6 years 9 months 18 days |
Options exercisable (in shares) | 1,558,247 |
$30.01 - $45.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 1,283,424 |
Options outstanding, weighted average remaining contractual life (in years) | 7 years 8 months 12 days |
Options exercisable (in shares) | 698,592 |
$45.01 - $55.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 1,233,270 |
Options outstanding, weighted average remaining contractual life (in years) | 8 years 3 months 18 days |
Options exercisable (in shares) | 513,798 |
$55.01 - $73.10 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding (in shares) | 789,601 |
Options outstanding, weighted average remaining contractual life (in years) | 8 years 2 months 12 days |
Options exercisable (in shares) | 388,945 |
Minimum | $0.20 - $10.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 0.20 |
Minimum | $10.01 - $20.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, lower range limit (in dollars per share) | $ / shares | 10.01 |
Minimum | $20.01 - $30.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, lower range limit (in dollars per share) | $ / shares | 20.01 |
Minimum | $30.01 - $45.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, lower range limit (in dollars per share) | $ / shares | 30.01 |
Minimum | $45.01 - $55.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, lower range limit (in dollars per share) | $ / shares | 45.01 |
Minimum | $55.01 - $73.10 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, lower range limit (in dollars per share) | $ / shares | 55.01 |
Maximum | $0.20 - $10.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, upper range limit (in dollars per share) | $ / shares | 10 |
Maximum | $10.01 - $20.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, upper range limit (in dollars per share) | $ / shares | 20 |
Maximum | $20.01 - $30.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, upper range limit (in dollars per share) | $ / shares | 30 |
Maximum | $30.01 - $45.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, upper range limit (in dollars per share) | $ / shares | 45 |
Maximum | $45.01 - $55.00 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, upper range limit (in dollars per share) | $ / shares | 55 |
Maximum | $55.01 - $73.10 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 73.1 |
Stock-based Compensation - Sc_4
Stock-based Compensation - Schedule of Restricted Stock Activity (Details) - Restricted stock | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
NUMBER OF SHARES | |
RSAs outstanding, beginning (in shares) | shares | 572,706 |
Granted, number of shares (in shares) | shares | 519,167 |
Vested (in shares) | shares | (214,276) |
Cancelled (in shares) | shares | (123,182) |
RSAs outstanding, ending (in shares) | shares | 754,415 |
WEIGHTED AVERAGE FAIR VALUE PER SHARE | |
RSAs outstanding, weighted average exercise price, beginning (in dollars per share) | $ / shares | $ 48.18 |
Granted, weighted average exercise price (in dollars per share) | $ / shares | 40.07 |
Vested, Weighted average exercise price (in dollars per share) | $ / shares | 45.76 |
Cancelled, weighted average exercise price (in dollars per share) | $ / shares | 49.64 |
RSAs outstanding, weighted average exercise price, ending (in dollars per share) | $ / shares | $ 43.07 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Appreciation Rights (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
WEIGHTED AVERAGE EXERCISE PRICE | |
Granted (in dollars per share) | $ / shares | $ 33.73 |
Stock Appreciation Rights (SARs) | |
NUMBER OF SHARES | |
Beginning balance (in shares) | shares | 91,000 |
Granted (in shares) | shares | 113,851 |
Exercised (in shares) | shares | 0 |
Canceled (in shares) | shares | (41,835) |
Ending balance (in shares) | shares | 163,016 |
Stock exercisable (in shares) | shares | 18,000 |
WEIGHTED AVERAGE EXERCISE PRICE | |
Beginning balance (in dollars per share) | $ / shares | $ 53.75 |
Exercised (in dollars per share) | $ / shares | 0 |
Canceled (in dollars per share) | $ / shares | 46.21 |
Ending balance (in dollars per share) | $ / shares | 41.70 |
Stock exercisable (in dollars per share) | $ / shares | $ 53.68 |
WEIGHTED AVERAGE REMAINING CONTRACTUAL LIFE (YEARS) | |
Stock outstanding, weighted average remaining contractual life | 3 years 10 months 24 days |
Stock exercisable, weighted average remaining contractual life | $ | $ 25 |
AGGREGATE INTRINSIC VALUE | |
Stock outstanding | 3 years 3 months 18 days |
Stock exercisable | $ | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | Aug. 01, 2018 | Oct. 31, 2017 | Dec. 31, 2019 |
Loss Contingencies [Line Items] | |||
Contingent liabilities relating to potential future milestone payments | $ 0 | ||
DSM Collaborative Arrangement | |||
Loss Contingencies [Line Items] | |||
Contingent payments due (up to) | $ 75,000,000 | ||
Envisia Therapeutics Inc. | |||
Loss Contingencies [Line Items] | |||
Milestone period | 15 years |
Segment Information (Details)
Segment Information (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)segment | Dec. 31, 2018USD ($) | |
Segment Reporting Information [Line Items] | ||
Number of operating segments | segment | 1 | |
Total long-lived assets | $ 58,147 | $ 60,525 |
United States | ||
Segment Reporting Information [Line Items] | ||
Total long-lived assets | 9,184 | 10,393 |
Ireland | ||
Segment Reporting Information [Line Items] | ||
Total long-lived assets | $ 48,963 | $ 50,132 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenues, net | $ 24,657 | $ 18,544 | $ 15,835 | $ 10,852 | $ 14,456 | $ 7,302 | $ 2,423 | $ 0 | $ 69,888 | $ 24,181 | $ 0 |
Total costs and expenses | 74,595 | 61,871 | 61,910 | 59,004 | 66,381 | 68,640 | 58,107 | 40,795 | 257,380 | 233,923 | 145,693 |
Net loss | $ (55,064) | $ (49,402) | $ (47,164) | $ (47,951) | $ (51,458) | $ (85,388) | $ (55,024) | $ (40,699) | $ (199,581) | $ (232,569) | $ (145,105) |
Net loss per common share—basic and diluted (in dollars per share) | $ (1.21) | $ (1.09) | $ (1.04) | $ (1.06) | $ (1.14) | $ (1.96) | $ (1.40) | $ (1.05) | $ (4.39) | $ (5.58) | $ (4.11) |
Uncategorized Items - aeri-1231
Label | Element | Value |
Accounting Standards Update 2016-16 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (2,122,000) |
Accounting Standards Update 2016-16 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (2,122,000) |