Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 01, 2020 | |
Document and Entity Information | ||
Entity Registrant Name | Esperion Therapeutics, Inc. | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-35986 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-1870780 | |
Entity Address, Address Line One | 3891 Ranchero Drive, SuiteĀ 150 | |
Entity Address, City or Town | Ann Arbor | |
Entity Address, State or Province | MI | |
Entity Address, Postal Zip Code | 48108 | |
City Area Code | 734 | |
Local Phone Number | 887-3903 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ESPR | |
Security Exchange Name | NASDAQ | |
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 Common Stock, Shares Outstanding | 27,825,428 | |
Entity Central Index Key | 0001434868 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 298,489 | $ 166,130 |
Restricted cash | 928 | |
Short-term investments | 2,247 | 34,651 |
Prepaid clinical development costs | 890 | 6,081 |
Inventories | 8,248 | |
Other prepaid and current assets | 11,497 | 3,924 |
Total current assets | 321,371 | 211,714 |
Property and equipment, net | 1,512 | 1,145 |
Right of use operating lease assets | 6,175 | 1,532 |
Other long-term assets | 1,294 | 56 |
Total assets | 330,352 | 214,447 |
Current liabilities: | ||
Accounts payable | 29,690 | 28,856 |
Accrued clinical development costs | 19,641 | 17,511 |
Other accrued liabilities | 21,908 | 11,871 |
Revenue interest liability | 9,276 | 5,236 |
Deferred revenue from collaborations | 1,134 | 2,152 |
Operating lease liabilities | 2,232 | 454 |
Total current liabilities | 83,881 | 66,080 |
Revenue interest liability | 157,015 | 127,308 |
Operating lease liabilities | 3,967 | 1,109 |
Total liabilities | 244,863 | 194,497 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized and no shares issued or outstanding as of June 30, 2020 and December 31, 2019 | ||
Common stock, $0.001 par value; 120,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 27,751,655 shares issued and outstanding at June 30, 2020 and 27,497,911 shares issued and outstanding at December 31, 2019 | 28 | 27 |
Additional paid-in capital | 734,365 | 715,166 |
Accumulated other comprehensive income | 23 | |
Accumulated deficit | (648,904) | (695,266) |
Total stockholders' equity | 85,489 | 19,950 |
Total liabilities and stockholders' equity | $ 330,352 | $ 214,447 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Condensed Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 27,751,655 | 27,497,911 |
Common stock, shares outstanding | 27,751,655 | 27,497,911 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Total Revenues | $ 212,236 | $ 982 | $ 214,076 | $ 146,401 |
Operating expenses: | ||||
Cost of goods sold | 398 | 429 | ||
Research and development | 34,987 | 42,788 | 69,689 | 89,096 |
Selling, general and administrative | 47,681 | 13,492 | 89,234 | 25,674 |
Total operating expenses | 83,066 | 56,280 | 159,352 | 114,770 |
Income (loss) from operations | 129,170 | (55,298) | 54,724 | 31,631 |
Interest expense | (4,640) | (8,811) | ||
Other income, net | 81 | 1,077 | 449 | 1,527 |
Net income (loss) | $ 124,611 | $ (54,221) | $ 46,362 | $ 33,158 |
Net income (loss) per common share - basic | $ 4.50 | $ (2.01) | $ 1.68 | $ 1.23 |
Net income (loss) per common share - diluted | $ 4.32 | $ (2.01) | $ 1.60 | $ 1.16 |
Weighted-average shares outstanding - basic | 27,665,728 | 26,968,818 | 27,592,479 | 26,906,149 |
Weighted-average shares outstanding - diluted | 28,854,445 | 26,968,818 | 28,948,058 | 28,518,015 |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on investments | $ (9) | $ 95 | $ (23) | $ 303 |
Comprehensive income (loss) | 124,602 | (54,126) | 46,339 | 33,461 |
Product sales, net | ||||
Revenues: | ||||
Total Revenues | 609 | 1,467 | ||
Collaboration revenue | ||||
Revenues: | ||||
Total Revenues | $ 211,627 | $ 982 | $ 212,609 | $ 146,401 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Balance at Dec. 31, 2018 | $ 27 | $ 677,511 | $ (598,101) | $ (319) | $ 79,118 |
Balance (in shares) at Dec. 31, 2018 | 26,824,859 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options | 1,669 | 1,669 | |||
Exercise of stock options (in shares) | 80,218 | ||||
Vesting of restricted stock units (in shares) | 3,125 | ||||
Stock-based compensation | 6,636 | 6,636 | |||
Other comprehensive gain (loss) | 208 | 208 | |||
Net income (loss) | 87,379 | 87,379 | |||
Balance at Mar. 31, 2019 | $ 27 | 685,816 | (510,722) | (111) | 175,010 |
Balance (in shares) at Mar. 31, 2019 | 26,908,202 | ||||
Balance at Dec. 31, 2018 | $ 27 | 677,511 | (598,101) | (319) | 79,118 |
Balance (in shares) at Dec. 31, 2018 | 26,824,859 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income (loss) | 33,158 | ||||
Balance at Jun. 30, 2019 | $ 27 | 694,266 | (564,943) | (16) | 129,334 |
Balance (in shares) at Jun. 30, 2019 | 27,036,652 | ||||
Balance at Mar. 31, 2019 | $ 27 | 685,816 | (510,722) | (111) | 175,010 |
Balance (in shares) at Mar. 31, 2019 | 26,908,202 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options | 1,887 | 1,887 | |||
Exercise of stock options (in shares) | 115,612 | ||||
Exercise of warrants (in shares) | 5,813 | ||||
Vesting of restricted stock units (in shares) | 7,025 | ||||
Stock-based compensation | 6,563 | 6,563 | |||
Other comprehensive gain (loss) | 95 | 95 | |||
Net income (loss) | (54,221) | (54,221) | |||
Balance at Jun. 30, 2019 | $ 27 | 694,266 | (564,943) | (16) | 129,334 |
Balance (in shares) at Jun. 30, 2019 | 27,036,652 | ||||
Balance at Dec. 31, 2019 | $ 27 | 715,166 | (695,266) | 23 | $ 19,950 |
Balance (in shares) at Dec. 31, 2019 | 27,497,911 | 27,497,911 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options | $ 1 | 1,013 | $ 1,014 | ||
Exercise of stock options (in shares) | 40,133 | ||||
Vesting of restricted stock units (in shares) | 10,089 | ||||
Stock-based compensation | 7,053 | 7,053 | |||
Other comprehensive gain (loss) | (14) | (14) | |||
Net income (loss) | (78,249) | (78,249) | |||
Balance at Mar. 31, 2020 | $ 28 | 723,232 | (773,515) | 9 | (50,246) |
Balance (in shares) at Mar. 31, 2020 | 27,548,133 | ||||
Balance at Dec. 31, 2019 | $ 27 | 715,166 | (695,266) | 23 | $ 19,950 |
Balance (in shares) at Dec. 31, 2019 | 27,497,911 | 27,497,911 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options (in shares) | 200,157 | ||||
Net income (loss) | $ 46,362 | ||||
Balance at Jun. 30, 2020 | $ 28 | 734,365 | (648,904) | $ 85,489 | |
Balance (in shares) at Jun. 30, 2020 | 27,751,655 | 27,751,655 | |||
Balance at Mar. 31, 2020 | $ 28 | 723,232 | (773,515) | 9 | $ (50,246) |
Balance (in shares) at Mar. 31, 2020 | 27,548,133 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options | 3,738 | 3,738 | |||
Exercise of stock options (in shares) | 160,024 | ||||
Vesting of restricted stock units (in shares) | 43,498 | ||||
Stock-based compensation | 7,395 | 7,395 | |||
Other comprehensive gain (loss) | $ (9) | (9) | |||
Net income (loss) | 124,611 | 124,611 | |||
Balance at Jun. 30, 2020 | $ 28 | $ 734,365 | $ (648,904) | $ 85,489 | |
Balance (in shares) at Jun. 30, 2020 | 27,751,655 | 27,751,655 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating activities | ||
Net income | $ 46,362 | $ 33,158 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation expense | 224 | 126 |
Accretion of premiums and discounts on investments | (93) | (121) |
Non-cash interest expense related to the revenue interest liability | 8,811 | |
Stock-based compensation expense | 14,448 | 13,199 |
Changes in assets and liabilities: | ||
Prepaids and other assets | (2,382) | 1,840 |
Deferred revenue | (1,018) | 3,599 |
Inventories | (8,248) | |
Other long-term assets | (1,238) | |
Accounts payable | 921 | (16,705) |
Other accrued liabilities | 12,257 | 2,586 |
Net cash provided by operating activities | 70,044 | 37,682 |
Investing activities | ||
Purchases of investments | (4,420) | |
Proceeds from sales/maturities of investments | 36,895 | 72,835 |
Purchase of property and equipment | (776) | (423) |
Net cash provided by investing activities | 31,699 | 72,412 |
Financing activities | ||
Proceeds from revenue interest liability | 25,000 | 124,649 |
Proceeds from exercise of common stock options | 4,752 | 3,556 |
Payments on revenue interest liability | (64) | |
Net cash provided by financing activities | 29,688 | 128,205 |
Net increase in cash and cash equivalents | 131,431 | 238,299 |
Cash, cash equivalents and restricted cash at beginning of period | 167,058 | 36,973 |
Cash, cash equivalents and restricted cash at end of period | 298,489 | 275,272 |
Supplemental disclosure of cash flow information: | ||
Issuance costs from revenue interest agreement not yet paid | 240 | |
Purchase of property and equipment not yet paid | 6 | 285 |
Non cash right of use asset | $ (7) | $ 26 |
The Company and Basis of Presen
The Company and Basis of Presentation | 6 Months Ended |
Jun. 30, 2020 | |
The Company and Basis of Presentation | |
The Company and Basis of Presentation | 1. The Company and Basis of Presentation ā Esperion Therapeutics, Inc. ("the Companyā) is the Lipid Management Company, a pharmaceutical company focused on developing and commercializing affordable, oral, once-daily, non-statin medicines for the treatment of patients with elevated low density lipoprotein cholesterol ("LDL-C"). Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease ("CVD"); the leading cause of death around the world. NEXLETOLĀ® (bempedoic acid) and NEXLIZET TM ā On February 21, 2020, the Company announced that the U.S. Food and Drug Administration (āFDAā) approved NEXLETOL an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients. NEXLETOL became commercially available on March 30, 2020. ā On February 26, 2020, the Company announced that the FDA approved NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. The effect of NEXLIZET on cardiovascular morbidity and mortality has not been determined. NEXLIZET is the first non-statin, LDL-C lowering fixed combination drug product ever approved. NEXLIZET became commercially available on June 4, 2020. ā On January 31, 2020, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") adopted a positive opinion for the Marketing Authorisation Applications ("MAAs") of both bempedoic acid and the bempedoic acid / ezetimibe combination tablets, recommending approval for the treatment of hypercholesterolemia and mixed dyslipidemia. On April 6, 2020, the Company announced that the European Commission (āECā) approved the NILEMDOā¢ (bempedoic acid) and NUSTENDIā¢ (bempedoic acid and ezetimibe) tablets for the treatment of hypercholesterolemia and mixed dyslipidemia. The decision is applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein. NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe) are the branded products names for bempedoic acid and the bempedoic acid / ezetimibe combination tablets in Europe. NILEMDO is the first, oral, non-statin, LDL-C lowering medicines approved in Europe in almost two decades for indicated patients, and NUSTENDI is the first non-statin, LDL-C lowering combination medicine ever approved in Europe. ā On April 17, 2020, the Company entered into a license and collaboration agreement (the "Otsuka Agreement") with Otsuka Pharmaceutical Co., Ltd. ("Otsuka"). Pursuant to the Otsuka Agreement, the Company granted Otsuka exclusive development and commercialization rights to NEXLETOL and NEXLIZET in Japan. Otsuka will be responsible for all development, regulatory, and commercialization activities in Japan. In addition, Otsuka will fund all clinical development costs associated with the program in Japan. The Company received an upfront cash payment of $60 million in April 2020 and will receive up to an additional $450 million in total development and sales milestones. The Company will also receive tiered royalties ranging from 15 percent to 30 percent on net sales in Japan. ā On June 18, 2020, the Company entered into an amendment to the license and collaboration agreement ("LCA Amendment") with Daiichi Sankyo Europe GmbH ("DSE") dated as of January 2, 2019. In June 2020, the Company completed the transfer of the MAAs for NILEMDO and NUSTENDI. Pursuant to the terms of the amendment, DSE paid the Company the second $150 million milestone based on completion of the NUSTENDI MAA transfer rather than the first product sale in the EU. Prior to the execution of the LCA Amendment, the milestone payment was due upon the first commercial sale in Europe, which is anticipated later this year. Additionally, the Company and DSE have agreed to expand the territory in which DSE has exclusive commercialization rights to NILEMDO and NUSTENDI to include Turkey. DSE's designated affiliate in Turkey will be solely responsible, at its sole cost and expense, for all regulatory matters relating to such products in Turkey, including obtaining Regulatory Approval for such product in Turkey. ā The Company's primary activities since incorporation have been conducting research and development activities, including nonclinical, preclinical and clinical testing, performing business and financial planning, recruiting personnel, and raising capital. The Company received approval by the FDA in February 2020 to commercialize NEXLETOL and NEXLIZET in the U.S., and accordingly commenced principal operations on March 30, 2020 with the commercialization of NEXLETOL. The Company is subject to risks and uncertainties which include the need to successfully commercialize its products, research, develop, and clinically test therapeutic products; obtain regulatory approvals for its products; expand its management, commercial and scientific staff; and finance its operations with an ultimate goal of achieving profitable operations. ā The Company has sustained annual operating losses since inception and expects such losses to continue over the foreseeable future. While management believes current cash resources and future cash received from the Company's net product sales, collaboration agreements with DSE and Otsuka, entered into on January 2, 2019 and April 17, 2020, respectively, and from the Revenue Interest Purchase Agreement (āRIPAā) with Eiger III SA LLC (āOberlandā), an affiliate of Oberland Capital LLC, and the Purchasers named therein, entered into on June 26, 2019, will fund operations for the foreseeable future, management may continue to fund operations and advance the development of the Company's products and product candidates through a combination of collaborations with third parties, strategic alliances, licensing arrangements, permitted debt financings, permitted royalty-based financings, and permitted private and public equity offerings or through other sources. ā If adequate funds are not available, the Company may not be able to continue the development of its current products or future product candidates, or to commercialize its current or future product candidates, if approved. ā Basis of Presentation ā The accompanying condensed interim financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (āGAAPā). In the opinion of management, the Company has made all adjustments, which include only normal recurring adjustments necessary for a fair presentation of the Companyās financial position and results of operations for the interim periods presented. Certain prior year amounts have been reclassified to conform with current year presentation. Certain information and disclosures normally included in the annual financial statements prepared in accordance with GAAP, but that is not required for interim reporting purposes, have been condensed or omitted. These condensed interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2019, and the notes thereto, which are included in the Companyās Annual Report on Form 10-K for the year ended December 31, 2019. The results of operations for the interim periods are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period. ā |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies ā Use of Estimates ā The preparation of financial statements in accordance with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, net revenues, expenses and related disclosures. Actual results could differ from those estimates. ā Concentration of Risk ā The Company enters into a limited number of distribution agreements with distributors and specialty pharmacies. The Company's net product sales are with these customers. As of June 30, 2020, one customer accounted for all of the Company's net trade receivables. ā Inventories ā Inventories are stated at the lower of cost or net realizable value and recognized on a first-in, first-out ("FIFO") method. The Company uses standard cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. The Company began capitalizing inventory upon receiving FDA approval for NEXLETOL and NEXLIZET on February 21, 2020 and February 26, 2020, respectively. Prior to the FDA approval of NEXLETOL and NEXLIZET, expenses associated with the manufacturing of the Company's products were recorded as research and development expense. ā The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of sales in the period in which they are incurred. ā Revenue Recognition ā In accordance with ASC 606, Revenue from Contracts with Customers, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with a customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when or as the entity satisfies a performance obligation. At contract inception 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 or as the performance obligation is satisfied. The Company derives revenue through two primary sources: collaboration revenue and product sales. Collaboration revenue consists of the collaboration payments to the Company for collaboration arrangements outside of the United States for the development, manufacturing and commercialization of the Company's product candidates by the Company's partners and product sales consists of sales of NEXLETOL and NEXLIZET. ā a. Collaboration Revenue ā The Company has entered into an agreement related to its activities to develop, manufacture, and commercialize its product candidates. The Company earns collaboration revenue in connection with a collaboration agreement to develop and/or commercialize product candidates where the Company deems the collaborator to be the customer. Revenue is recognized when (or as) the Company satisfies performance obligations under the terms of a contract. Depending on the terms of the arrangement, the Company may defer the recognition of all or a portion of the consideration received as the performance obligations are satisfied. ā The collaboration agreements may require the Company to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In an agreement involving multiple goods or services promised to be transferred to a customer, the Company must assess, at the inception of the contract, whether each promise represents a separate performance obligation (i.e., is "distinct"), or whether such promises should be combined as a single performance obligation. ā The terms of the agreement typically include consideration to be provided to the Company in the form of non-refundable up-front payments, development milestones, sales milestones, and royalties on sales of products within a respective territory. The Company recognizes regulatory and approval milestones consideration when it is probable that a future reversal is unlikely to occur. For sales based milestones and royalties based on sales of product in a territory, the Company applies the sales-based royalty exception in ASC 606-10-55-65 to all of these milestones and royalties. ā At the inception of the contract, the transaction price reflects the amount of consideration the Company expects to be entitled to in exchange for transferring promised goods or services to its customer. In the arrangement where the Company satisfies performance obligation(s) during the regulatory phase over time, the Company recognizes collaboration revenue typically using an input method on the basis of regulatory costs incurred relative to the total expected cost which determines the extent of progress toward completion. The Company reviews the estimate of the transaction price and the total expected cost each period and makes revisions to such estimates as necessary. Under contracted supply agreements with collaborators, the Company may manufacture and supply quantities of active pharmaceutical ingredient (āAPIā) or bulk tablets reasonably required by collaboration partners for the development or sale of licensed products in their respective territory. The Company recognizes revenue when the collaboration partner has obtained control of the API or bulk tablets. The Company records the costs related to the supply agreement in cost of goods sold on the condensed statements of operations and comprehensive income (loss). ā Under the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. The Company receives royalties from the commercialization of such products, and records its share of the variable consideration, representing a percentage of net product sales, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborator. The collaborator will provide the Company with estimates of its royalties for such quarterĶ¾ these estimates are reconciled to actual results in the subsequent quarter, and the royalty is adjusted accordingly, as necessary. ā b. Product Sales, Net On February 21, 2020, the Company announced that the FDA approved NEXLETOL as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. On February 26, 2020, the Company announced that the FDA approved NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. On March 30, 2020, NEXLETOL was commercially available in the U.S. through prescription and on June 4, 2020, NEXLIZET was commercially available in the U.S. through prescription. Net product sales totaled $0.6 million and $1.5 million for the three and six months ended June 30, 2020, respectively. ā The Company sells NEXLETOL and NEXLIZET to wholesalers in the U.S and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customersā distribution facilities, or free on board (āFOBā) destination, the terms of which are designated in the contract. ā Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Given the early stage of the Companyās commercial operations it has provided constraint of its variable consideration due to its potential consumption trends. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. ā Liabilities for co-pay assistance, expected product returns, rebates, and distributor fees are classified as āOther accrued liabilitiesā in the condensed balance sheets. Discounts, such as prompt pay discounts, and chargebacks are recorded as a reduction to trade accounts receivable, which is included in āOther prepaid and current assetsā in the condensed balance sheets. ā Forms of Variable Consideration ā Rebates and Chargebacks: ā Co-pay assistance: ā Distribution Fees: ā Product Returns: ā Discounts: ā Recently Implemented Accounting Pronouncements ā In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (āASUā) 2016-13 which requires financial instruments to be recognized at an estimate of current expected credit losses. As part of the ASU, financial assets measured at amortized cost will be presented at the net amount expected to be collected. In addition, companies will recognize an allowance for credit losses on available-for-sale investments rather than reducing the amortized cost in an other-than-temporary impairment. The Company has chosen the practical expedient to exclude accrued interest from both the fair value and the amortized cost basis of available-for-sale debt securities in identifying and measuring an impairment. The Company adopted the standard on January 1, 2020. The adoption of this standard did not have a material impact on the Company's balance sheets, statements of operations or statements of cash flows. ā In August 2018, the FASB issued ASU 2018-15 which includes provisions to clarify customer's accounting for implementation costs incurred in a cloud computing arrangement. Under the updated guidance, a customer in a cloud computing arrangement that is a service contract should follow the internal-use software guidance to determine how to account for costs incurred in implementation. The updated guidance also requires certain classification on the balance sheets, statements of operations and statements of cash flows as well as additional quantitative and qualitative disclosures. The Company adopted the standard effective January 1, 2020 and has chosen to adopt the standard prospectively. Implementation costs for cloud computing arrangements are capitalized in "Other prepaid and current assets" on the Company's balance sheets. The adoption of this standard did not have a material impact to the Company's balance sheets, statements of operations or statements of cash flows. ā There have been no other material changes to the significant accounting policies previously disclosed in the Companyās Annual Report on Form 10-K for the fiscal year ended December 31, 2019. ā |
Collaborations with Third Parti
Collaborations with Third Parties | 6 Months Ended |
Jun. 30, 2020 | |
Collaborations with Third Parties | |
Collaborations with Third Parties | 3. Collaborations with Third Parties ā DSE Agreement Terms ā On January 2, 2019, the Company entered into a license and collaboration agreement with DSE. Pursuant to the agreement, the Company granted DSE exclusive commercialization rights to bempedoic acid and the bempedoic acid / ezetimibe combination tablets in the European Economic Area and Switzerland (āDSE Territoryā). DSE will be responsible for commercialization in the DSE Territory. The Company remains responsible for clinical development, regulatory and manufacturing activities for the licensed products globally, including in the DSE Territory. ā Pursuant to the agreement, the consideration consists of a $150.0 million upfront cash payment as well as $150.0 million cash payment to the Company upon first commercial sales in the DSE Territory. The Company also is responsible to supply DSE with certain manufacturing supply of the API or bulk tablets. The Company is also eligible to receive a substantial additional regulatory milestone payment upon the grant of the marketing authorisation in the European Union for the CV risk reduction label, depending on the range of relative risk reduction in the CLEAR Outcomes study. In addition, the Company is eligible to receive additional sales milestone payments related to total net sales achievements for DSE in the DSE Territory. Finally, the Company will receive tiered fifteen percent ( ā The agreement calls for both parties to participate in a Joint Collaboration Committee (the āDSE JCCā). The DSE JCC is comprised of executive management from each company and the Company will lead in all aspects related to development and DSE will lead in all aspects related to commercialization in the DSE Territory. ā Agreement Terms Amendment ā On June 18, 2020, the Company entered into an amendment to the license and collaboration agreement with DSE, dated as of January 2, 2019. In June, the Company completed the transfer of the MAAs for NILEMDO and NUSTENDI. Pursuant to the terms of the amendment, DSE paid the Company the second $150.0 million milestone based on completion of the NUSTENDI MAA transfer rather than the first product sale in the EU, as previously agreed. Additionally, the Company and DSE have agreed to expand the DSE Territory, or the territory in which DSE has exclusive commercialization rights to NILEMDO and NUSTENDI to include Turkey. DSE's designated affiliate in Turkey will be solely responsible, at its sole cost and expense, for all regulatory matters relating to such products in Turkey, including obtaining regulatory approval for such products in Turkey. ā Collaboration Revenue ā The Company considered the guidance under ASC 606 and concluded that the agreement was in the scope of ASC 606. The Company concluded that the upfront payment of $150.0 million should be included in the transaction price and related to the following performance obligations under the agreement: 1) the license to the Companyās intellectual property and 2) the obligation to provide ongoing regulatory and development activities. The Company used the adjusted market assessment approach in determining the standalone selling price of the Companyās intellectual property and the expected cost plus margin approach in determining the standalone selling price of the Companyās obligation to provide ongoing regulatory and development activities. In the three and six months ended June 30, 2019, the Company recognized $1.0 million and $146.4 million of collaboration revenue, respectively. In the three and six months ended June 30, 2020, the Company recognized approximately $0.7 million and $1.6 million, respectively, related to the on-going performance obligation for the ongoing regulatory efforts related to the MAA in the DSE Territory, which was transferred to DSE in June 2020. ā In addition, in the three and six months ended June 30, 2020, the Company recognized the $150.0 million milestone as collaboration revenue based on the successful transfer of the NUSTENDI MAA. In the three and six months ended June 30, 2020, the Company recognized collaboration revenue of $1.0 million related to the sales of bulk tablets of NILEMDO and NUSTENDI to DSE pursuant to the Supply Agreement that was executed with DSE. ā All remaining future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606 due to the fact that such amounts hinge on development activities, regulatory approvals and sales-based milestones. Additionally, the Company expects that any consideration related to royalties and sales-based milestones will be recognized when the subsequent sales occur. ā Otsuka Agreement Terms ā On April 17, 2020, the Company entered into the Otsuka Agreement with Otsuka. Pursuant to the Otsuka Agreement, the Company granted Otsuka exclusive development and commercialization rights to NEXLETOL and NEXLIZET in Japan. Otsuka will be responsible for all development, regulatory, and commercialization activities in Japan. In addition, Otsuka will fund all clinical development costs associated with the program in Japan. ā Pursuant to the agreement, the consideration consists of a $60.0 million upfront cash payment and the Company will be eligible to receive additional payments of up to $450.0 million if certain regulatory and commercial milestones are achieved by Otsuka. The potential future milestone payments include up to $20.0 million upon first JNDA submissions in the Otsuka Territory, up to $70.0 million upon the first NHI Price Listing for NEXLETOL in the Otsuka Territory, and up to $50.0 million upon the achievement of the primary major adverse cardiovascular events (āMACEā) in the CLEAR Outcomes study and the CV risk reduction rate on the U.S. label, depending on the range of relative risk reduction in the CLEAR Outcomes study. In addition, the Company is eligible to receive additional sales milestone payments up to $310.0 million related to total net sales achievements for Otsuka in Japan. Finally, the Company will receive tiered fifteen percent (15%) to thirty percent (30%) royalties on net sales in Japan. ā The agreement calls for both parties to participate in a Joint Collaboration Committee (the "Otsuka JCC"). The Otsuka JCC is comprised of executive management from each company and Otsuka will lead in all aspects related to development and commercialization in the Otsuka Territory. ā Collaboration Revenue ā The Company considered the guidance under ASC 606 and concluded that the agreement was in the scope of ASC 606. The Company concluded that the upfront payment of $60.0 million should be included in the transaction price and related to the performance obligation under the agreement to the license to the Company's intellectual property. In the three and six months ended June 30, 2020, the Company recognized $60.0 million of collaboration revenue related to the $60.0 million upfront payment. ā All future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606 due to the fact that such amounts hinge on development activities, regulatory approvals and sales-based milestones. Additionally, the Company expects that any consideration related to royalties and sales-based milestones will be recognized when the subsequent sales occur. ā The Company has not yet recognized any revenue for milestone payments as the related regulatory and commercial milestones have not yet been achieved. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2020 | |
Inventories | |
Inventories | 4. Inventories ā Inventories as of June 30, 2020 and December 31, 2019 consist of the following (in thousands): ā ā ā ā ā ā ā ā ā June 30, 2020 December 31, 2019 Raw materials ā $ 4,961 ā $ ā Work in process ā 2,869 ā ā Finished goods ā 418 ā ā ā ā $ 8,248 ā $ ā ā The Company has entered into a contract manufacturing agreement with a third party commercial manufacturing organization for the production of certain inventory supplies of NEXLETOL and NEXLIZET. The agreement has an initial term of three years and will renew automatically for successive periods of one year each unless terminated by either party. Under the agreement the Company is obligated to purchase minimum order commitments on a rolling twelve-month period for the batches of inventory supplies produced. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 5. Commitments and Contingencies ā On January 12, 2016, a purported stockholder of the Company filed a putative class action lawsuit in the United States District Court for the Eastern District of Michigan, against the Company and Tim Mayleben, captioned Kevin L. Dougherty v. Esperion Therapeutics, Inc., et al. ā On December 15, 2016, a purported stockholder of the Company filed a derivative lawsuit in the Court of Chancery of the State of Delaware against Tim Mayleben, Roger Newton, Mary McGowan, Nicole Vitullo, Dov Goldstein, Daniel Janney, Antonio Gotto Jr., Mark McGovern, Gilbert Omenn, Scott Braunstein, and Patrick Enright. The Company is named as a nominal defendant. The lawsuit alleges that the defendants breached their fiduciary duties to the Company when they made or approved improper statements on August 17, 2015, regarding the Companyās lead product candidateās path to FDA approval, and failed to ensure that reliable systems of internal controls were in place at the Company. On February 8, 2019, the Company and defendants filed a motion to dismiss the derivative lawsuit. On April 23, 2019, the plaintiff filed an opposition to the motion to dismiss the derivative lawsuit, and the Company filed a reply brief on May 15, 2019. On November 6, 2019, the court held a hearing on the motion to dismiss. On February 13, 2020, the court granted the motion to dismiss with prejudice and entered judgment in the Companyās favor. On March 16, 2020, the plaintiff filed a notice of appeal to the Supreme Court of Delaware. On June 1, 2020, the plaintiff filed his opening brief on appeal to the Supreme Court of Delaware. On July 1, 2020, the Company and the defendants filed an answering brief. The lawsuit seeks, among other things, any damages sustained by the Company as a result of the defendantsā alleged breaches of fiduciary duties, including damages related to the above-referenced securities class action, an order directing the Company to take all necessary actions to reform and improve its corporate governance and internal procedures, restitution from the defendants, and attorneysā fees and costs. The Company is unable to predict the outcome of this matter and is unable to make a meaningful estimate of the amount or range of loss, if any, that could result from an unfavorable outcome. ā There have been no other material changes to the Companyās contractual obligations and commitments and contingencies outside the ordinary course of business from those previously disclosed in the Companyās Annual Report on Form 10-K for the fiscal year ended December 31, 2019 other than the Revenue Interest Purchase Agreement disclosed in Note 8 āLiability Related to the Revenue Interest Purchase Agreement.ā |
Investments
Investments | 6 Months Ended |
Jun. 30, 2020 | |
Investments | |
Investments | 6. Investments ā The following table summarizes the Companyās cash equivalents and short-term investments: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā June 30, 2020 ā ā ā Gross Gross Estimated ā ā Amortized ā Unrealized ā Unrealized ā Fair ā Cost Gains Losses Value ā ā (in thousands) Cash equivalents: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 287,632 ā $ ā ā $ ā ā $ 287,632 Short-term investments: ā ā ā ā ā ā ā ā ā ā ā ā Commercial paper ā 2,247 ā ā ā ā ā 2,247 Total ā $ 289,879 ā $ ā ā $ ā ā $ 289,879 ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā December 31, 2019 ā ā ā Gross Gross Estimated ā ā Amortized ā Unrealized ā Unrealized ā Fair ā Cost Gains Losses Value ā ā (in thousands) Cash equivalents: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 20,970 ā $ ā ā $ ā ā $ 20,970 U.S. treasury notes ā ā 2,497 ā ā ā ā ā ā ā ā 2,497 Commercial paper ā ā 4,494 ā ā ā ā ā ā ā ā 4,494 Short-term investments: ā ā ā ā ā ā ā ā ā ā ā ā Certificates of deposit ā ā 245 ā ā ā ā ā ā ā ā 245 U.S treasury notes ā 29,155 ā 23 ā ā ā 29,178 Commercial paper ā 5,228 ā ā ā ā ā 5,228 Total ā $ 62,589 ā $ 23 ā $ ā ā $ 62,612 ā At June 30, 2020, remaining contractual maturities of investments classified as current on the balance sheets were less than 12 months. ā During the three and six months ended June 30, 2020, other income, net in the statements of operations includes interest income on investments of $0.1 million and $0.5 million, respectively, and income for the accretion of premiums and discounts on investments of less than $0.1 million and $0.1 million, respectively. During the three and six months ended June 30, 2019, other income, net in the statements of operations includes interest income on investments of $1.0 million and $1.4 million, respectively, and income for the accretion of premiums and discounts on investments of less than $0.1 million and $0.1 million, respectively. ā There were no unrealized gains or losses on investments reclassified from accumulated other comprehensive income (loss) to other income in the statements of operations during the three and six months ended June 30, 2020 and 2019. ā In the three and six months ended June 30, 2020, there were no allowances for credit losses and all unrealized gains (losses) for available-for-sale securities were recognized in accumulated other comprehensive income. As of June 30, 2020, the Company had no accrued interest receivables. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 7. Fair Value Measurements ā The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as āthe price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.ā Fair value measurements are defined on a three level hierarchy: ā ā ā ā Level 1 inputs: Quoted prices for identical assets or liabilities in active markets; ā ā ā Level 2 inputs: ā Observable inputs other than Level 1 prices, such as quoted market prices for similar assets or liabilities or other inputs that are observable or can be corroborated by market data; and ā ā ā Level 3 inputs: ā Unobservable inputs that are supported by little or no market activity and require the reporting entity to develop assumptions that market participants would use when pricing the asset or liability. ā The following table presents the Companyās financial assets that have been measured at fair value on a recurring basis: ā ā ā ā ā ā ā ā ā ā ā ā ā ā Description Total Level 1 Level 2 Level 3 ā ā (in thousands) June 30, 2020 ā ā ā ā ā ā ā ā ā ā ā ā Assets: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 287,632 ā $ 287,632 ā $ ā ā $ ā Investments: ā ā ā ā ā ā ā ā ā ā ā ā Commercial paper ā 2,247 ā ā ā 2,247 ā ā Total assets at fair value ā $ 289,879 ā $ 287,632 ā $ 2,247 ā $ ā December 31, 2019 ā ā ā ā ā ā ā ā ā ā ā ā Assets: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 20,970 ā $ 20,970 ā $ ā ā $ ā Investments: ā ā ā ā ā ā ā ā ā ā ā ā Certificates of deposit ā 245 ā 245 ā ā ā ā U.S. treasury notes ā 31,675 ā 31,675 ā ā ā ā Commercial paper ā 9,722 ā ā ā 9,722 ā ā Total assets at fair value ā $ 62,612 ā $ 52,890 ā $ 9,722 ā $ ā ā There were no transfers between Levels 1, 2 or 3 during the three and six months ended June 30, 2020 and 2019. |
Liability Related to the Revenu
Liability Related to the Revenue Interest Purchase Agreement | 6 Months Ended |
Jun. 30, 2020 | |
Liability Related to the Revenue Interest Purchase Agreement | |
Liability Related to the Revenue Interest Purchase Agreement | 8. Liability Related to the Revenue Interest Purchase Agreement ā On June 26, 2019, the Company entered into a RIPA with Oberland, as agent for purchasers party thereto (the āPurchasersā), and the Purchasers named therein, to obtain financing in respect to the commercialization and further development of bempedoic acid and the bempedoic acid / ezetimibe combination tablets and other working capital needs. Pursuant to the RIPA, the Company received $125.0 million at closing, less certain issuance costs. The Company is also entitled to receive up to approximately $75.0 million in subsequent installments subject to the terms and conditions set forth in the RIPA: (i) $25.0 million upon certain regulatory approval of its product candidates and (ii) $50.0 million, at the Companyās option, upon reaching $100.0 million trailing worldwide six-month net sales any time prior to December 31, 2021 (the āThird Paymentā). In March 2020, the Company received $25.0 million from Oberland upon receiving regulatory approval of NEXLETOL. ā As consideration for such payments, the Purchasers have a right to receive certain revenue interests (the āRevenue Interestsā) from the Company based upon net sales of the Companyās certain products which will be tiered payments initially ranging from 2.5% to 7.5% of the Companyās net sales in the covered territory (the āCovered Territoryā); provided that (a) if annual net sales equal or exceed $350.0 million by December 31, 2021 (the āSales Thresholdā), the initially tiered revenue interest rate will be decreased to a single rate of 2.5% of the Companyās net sales in the Covered Territory, beginning on January 1, 2022, and (b) if annual net sales equal or exceed the Sales Threshold and if the Purchasers receive 100% of their invested capital by December 31, 2024, the revenue interest rate will be decreased to a single rate of 0.4% of the Companyās net sales in the Covered Territory beginning on January 1, 2025. If the Third Payment is drawn down by the Company, the applicable royalty rates will increase by one-third . The Covered Territory is the United States, but is subject to expand to include the world-wide net sales if the Companyās annual U.S. net sales are less than $350.0 million for the year ended December 31, 2021. The U.S. net sales milestone thresholds are not to be taken as financial guidance. The Purchasersā rights to receive the Revenue Interests shall terminate on the date on which the Purchasers have received Revenue Interests payments of 195% of the then aggregate purchase price (the āCumulative Purchaser Paymentsā) paid to the Company, unless the RIPA is terminated earlier. ā Under the RIPA, the Company has an option (the āCall Optionā) to terminate the RIPA and repurchase future Revenue Interests at any time upon advance written notice. Additionally, the Purchasers have an option (the āPut Optionā) to terminate the RIPA and to require the Company to repurchase future Revenue Interests upon enumerated events such as a bankruptcy event, an uncured material breach, a material adverse effect or a change of control. If the Put Option is exercised prior to the first anniversary of the closing date by the Purchasers (except pursuant to a change of control), the required repurchase price will be 120% of the Cumulative Purchaser Payments (minus all payments Company has made to the Purchasers in connection with the Revenue Interests). In all other cases, if the Put Option or the Call Option are exercised, the required repurchase price will be 175% of the Cumulative Purchaser Payments (minus all payments Company has made to the Purchasers in connection with the Revenue Interests), if such option is exercised prior to the third anniversary of the closing date, and 195% of the Cumulative Purchaser Payments (minus all payments Company has made to the Purchasers in connection with the Revenue Interests), if such option is exercised thereafter. ā In addition, the RIPA contains various representations and warranties, information rights, non-financial covenants, indemnification obligations and other provisions that are customary for a transaction of this nature. ā In connection with the arrangement, as of June 30, 2020, the Company has recorded a liability, referred to as the āRevenue interest liabilityā in the condensed balance sheets, of $166.3 million, net of $0.5 million of capitalized issuance costs in connection with the RIPA. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. ā A significant increase or decrease in net sales will materially impact the revenue interest liability, interest expense and the time period for repayment. The Company recorded approximately $4.6 million and $8.8 million in interest expense related to this arrangement for the three and six months ended June 30, 2020, respectively. ā The Company received $125.0 million in exchange for entering into the RIPA and $25.0 million in March 2020 upon receiving regulatory approval of NEXLETOL. The effective annual imputed interest rate is 10.1%. The Company incurred $0.6 million of issuance costs in connection with the RIPA, which will be amortized to interest expense over the estimated term of the RIPA. Payments made to Oberland as a result of the Companyās net sales will reduce the revenue interest liability. ā The following table summarizes the revenue interest liability activity during the six months ended June 30, 2020: ā ā ā ā ā ā (in thousands) Revenue interest liability at December 31, 2019 ā $ 132,544 Oberland funding for regulatory approval of NEXLETOL ā 25,000 Interest expense recognized ā 8,811 Revenue Interests payments ā ā (64) Revenue interest liability at June 30, 2020 ā $ 166,291 ā |
Other Accrued Liabilities
Other Accrued Liabilities | 6 Months Ended |
Jun. 30, 2020 | |
Other Accrued Liabilities | |
Other Accrued Liabilities | 9. Other Accrued Liabilities ā Other accrued liabilities consist of the following: ā ā ā ā ā ā ā ā ā June 30, December 31, ā ā 2020 ā 2019 ā ā (in thousands) Accrued compensation ā $ 10,868 ā $ 7,818 Accrued professional fees ā 5,864 ā 3,842 Accrued inventory ā 1,771 ā ā Accrued other ā 3,405 ā 211 Total other accrued liabilities ā $ 21,908 ā $ 11,871 ā |
Stock Compensation
Stock Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Stock Compensation | |
Stock Compensation | 10. Stock Compensation ā Employee Stock Purchase Plan ā In April 2020, the board of directors approved the Esperion Therapeutics, Inc. 2020 Employee Stock Purchase Plan (the "ESPP") which was approved by the Company's shareholders on May 28, 2020. The ESPP allows eligible employees to authorize payroll deductions of up to 10% of their base salary or wages up to $25,000 annually to be applied toward the purchase of shares of the Company's common stock on the last trading day of the offering period. Participating employees will purchase shares of the Company's common stock at a discount of up to 15% on the lesser of the closing price of the Company's common stock on the NASDAQ Global Select Market (i) on the first trading day of the offering period or (ii) the last day of any offering period. Offering periods under the ESPP will generally be in six month increments, commencing on September 1 and March 1 of each calendar year with the administrator having the right to establish different offering periods. ā The following table summarizes the activity relating to the Companyās options to purchase common stock for the six months ended June 30, 2020: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā Weighted-Average ā Weighted-Average ā ā ā ā ā ā ā Exercise ā Remaining ā Aggregate ā ā Number of ā Price ā Contractual ā Intrinsic ā Options Per Share Term (Years) Value ā ā ā ā ā ā ā ā ā (in thousands) Outstanding at December 31, 2019 4,677,929 ā $ 39.31 6.82 ā $ 109,054 Granted 234,940 ā $ 61.14 ā ā ā ā ā Forfeited or expired (134,945) ā $ 56.38 ā ā ā ā ā Exercised (200,157) ā $ 23.74 ā ā ā ā ā Outstanding at June 30, 2020 4,577,767 ā $ 40.61 6.10 ā $ 72,396 ā The following table summarizes information about the Companyās stock option plan as of June 30, 2020: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā Weighted-Average ā Weighted-Average ā ā ā ā ā ā ā Exercise ā Remaining ā Aggregate ā ā Number of ā Price ā Contractual ā Intrinsic ā Options Per Share Term (Years) Value ā ā ā ā ā ā ā ā ā (in thousands) Vested and expected to vest at June 30, 2020 4,577,767 ā $ 40.61 6.10 ā $ 72,396 Exercisable at June 30, 2020 3,195,452 ā $ 35.88 5.12 ā $ 65,786 ā Stock-based compensation related to stock options was $5.5 million and $11.1 million for the three and six months ended June 30, 2020, respectively, including $0.3 million and $0.5 million for the three and six months ended June 30, 2020, respectively, that were capitalized into inventory, and $6.2 million and $12.6 million for the three and six months ended June 30, 2019, respectively. As of June 30, 2020, there was $44.0 million of unrecognized stock-based compensation expense related to unvested options, which will be recognized over a weighted-average period of 2.4 years. ā The following table summarizes the activity relating to the Companyās RSUs for the six months ended June 30, 2020: ā ā ā ā ā ā ā ā ā Weighted-Average ā ā Number of ā Fair Value Per ā ā RSUs ā Share Outstanding and unvested at December 31, 2019 245,966 ā $ 44.45 Granted 322,167 ā $ 52.82 Forfeited ā (28,921) ā $ 44.70 Vested (53,587) ā $ 51.98 Outstanding and unvested at June 30, 2020 485,625 ā $ 49.16 ā Stock-based compensation related to RSUs was approximately $1.8 million and $3.3 million for the three and six months ended June 30, 2020, respectively, including $0.1 million and $0.1 million for the three and six months ended June 30, 2020, respectively, that were capitalized into inventory, and $0.4 million and $0.6 million for the three and six months ended June 30, 2019, respectively. As of June 30, 2020, there was $21.5 million of unrecognized stock-based compensation expense related to unvested RSUs, which will be recognized over a weighted-average period of 3.2 years. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2020 | |
Leases | |
Leases | 11. Leases ā The Company has operating leases primarily related to the Companyās principal executive office, automobile leases and other IT related equipment. The lease for the principal executive office has a lease term of 5 years and the automobile leases and IT equipment leases primarily have a term of 3 years. During the six months ended June 30, 2020, the right of use operating lease assets and operating lease liabilities recognized on the condensed balance sheet increased by $4.6 million and $4.6 million from December 31, 2019, respectively, due to the addition of automobile leases and IT equipment associated with the onboarding of the Companyās commercial salesforce to support the commercialization of NEXLETOL and NEXLIZET. During the three and six months ended June 30, 2020, the Company recognized $0.6 million and $0.8 million, respectively, of operating lease costs, recognized on the condensed statements of operations, and paid cash for the amounts included in the measurement of lease liabilities of $0.6 million and $0.8 million, respectively, which were included in operating cash flows on the condensed statements of cash flows. During the three and six months ended June 30, 2019, the Company recognized less than $0.1 million and $0.1 million, respectively, of operating lease costs, recognized on the condensed statements of operations, and paid cash for the amounts included in the measurement of lease liabilities of less than $0.1 million and $0.1 million, respectively, which were included in operating cash flows on the condensed statements of cash flows. At June 30, 2020, the weighted-average remaining lease term of operating leases was 2.7 years and the weighted average discount rate was 3.6%. There were no right-of-use assets obtained in exchange for lease obligations in the six months ended June 30, 2020 or 2019. The Company had no additional operating and finance leases that have not yet commenced as of June 30, 2020 or 2019. ā The following table summarizes the Companyās future maturities of operating lease liabilities as of June 30, 2020: ā ā ā ā ā ā (in thousands) 2020 (remaining) ā $ 1,209 2021 ā 2,380 2022 ā 2,333 2023 ā 584 2024 ā ā Total lease payments ā 6,506 Less imputed interest ā 307 Total ā $ 6,199 ā |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Taxes | |
Income Taxes | 12. Income Taxes ā There was no provision for income taxes for the three and six months ended June 30, 2020 and 2019, because the Company has incurred annual operating losses since inception. At June 30, 2020, the Company continues to conclude that it is not more likely than not that the Company will realize the benefit of its deferred tax assets due to its history of losses. Accordingly, a full valuation allowance has been applied against the net deferred tax assets. |
Net Income (Loss) Per Common Sh
Net Income (Loss) Per Common Share | 6 Months Ended |
Jun. 30, 2020 | |
Net Income (Loss) Per Common Share | |
Net Income (Loss) Per Common Share | 13. Net Income (Loss) Per Common Share ā Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net income per share is computed by dividing net income by the weighted-average number of common stock equivalents outstanding for the period, including shares that potentially could be dilutive if they were exercised during the period, determined using the treasury-stock method. For purposes of this calculation, stock options and unvested RSUs are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The following table summarizes the calculation of basic and diluted net income (loss) per share: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the three months ended , ā For the six months ended , ā June 30, June 30, June 30, June 30, ā ā 2020 ā 2019 ā 2020 ā 2019 Net income (loss) (in thousands) ā $ 124,611 ā $ (54,221) ā $ 46,362 ā $ 33,158 ā ā ā ā ā ā ā ā ā ā ā ā ā Weighted average common shares outstanding - basic ā 27,665,728 ā 26,968,818 ā 27,592,479 ā 26,906,149 Effect of dilutive shares: ā ā ā ā ā ā ā ā Warrants for common stock ā ā ā ā ā ā ā 4,230 Common shares under option ā 1,139,280 ā ā ā 1,291,353 ā 1,607,093 Unvested RSUs ā 49,437 ā ā ā 64,226 ā 543 Dilutive shares ā 1,188,717 ā ā ā 1,355,579 ā 1,611,866 Weighted average common shares outstanding - diluted ā 28,854,445 ā 26,968,818 ā 28,948,058 ā 28,518,015 ā ā ā ā ā ā ā ā ā ā ā ā ā Net income (loss) per common share - basic ā $ 4.50 ā $ (2.01) ā $ 1.68 ā $ 1.23 Net income (loss) per common share - diluted ā $ 4.32 ā $ (2.01) ā $ 1.60 ā $ 1.16 ā The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net income (loss) per share due to their anti-dilutive effect: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the three months ended , ā For the six months ended , ā June 30, ā June 30, ā June 30, ā June 30, ā 2020 2019 2020 2019 Common shares under option ā 2,427,074 ā 5,322,686 ā 2,391,374 ā 2,511,692 Unvested RSUs ā 295,423 ā 83,778 ā 190,565 ā 77,653 Total potential dilutive shares ā 2,722,497 ā 5,406,464 ā 2,581,939 ā 2,589,345 ā |
Statements of Cash Flows
Statements of Cash Flows | 6 Months Ended |
Jun. 30, 2020 | |
Statements of Cash Flows. | |
Statements of Cash Flows | 14. Statements of Cash Flows ā The following table provides a reconciliation of cash and cash equivalents and restricted cash presented on the condensed balance sheets to the same amounts presented on the condensed statements of cash flows on June 30, 2020 and 2019 and December 31, 2019 and 2018 (in thousands): ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā June 30, ā June 30, ā December 31, ā December 31, ā 2020 2019 2019 2018 Cash and cash equivalents ā $ 298,489 ā $ 274,344 ā $ 166,130 ā $ 36,973 Restricted cash ā ā ā 928 ā 928 ā ā Total cash and cash equivalents and restricted cash shown on the condensed statements of cash flows ā $ 298,489 ā $ 275,272 ā $ 167,058 ā $ 36,973 ā |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Summary of Significant Accounting Policies | |
Use of Estimates | Use of Estimates ā The preparation of financial statements in accordance with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, net revenues, expenses and related disclosures. Actual results could differ from those estimates. ā |
Concentration of Risk | Concentration of Risk ā The Company enters into a limited number of distribution agreements with distributors and specialty pharmacies. The Company's net product sales are with these customers. As of June 30, 2020, one customer accounted for all of the Company's net trade receivables. ā |
Inventories | Inventories ā Inventories are stated at the lower of cost or net realizable value and recognized on a first-in, first-out ("FIFO") method. The Company uses standard cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. The Company began capitalizing inventory upon receiving FDA approval for NEXLETOL and NEXLIZET on February 21, 2020 and February 26, 2020, respectively. Prior to the FDA approval of NEXLETOL and NEXLIZET, expenses associated with the manufacturing of the Company's products were recorded as research and development expense. ā The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of sales in the period in which they are incurred. |
Revenue Recognition | Revenue Recognition ā In accordance with ASC 606, Revenue from Contracts with Customers, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with a customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when or as the entity satisfies a performance obligation. At contract inception 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 or as the performance obligation is satisfied. The Company derives revenue through two primary sources: collaboration revenue and product sales. Collaboration revenue consists of the collaboration payments to the Company for collaboration arrangements outside of the United States for the development, manufacturing and commercialization of the Company's product candidates by the Company's partners and product sales consists of sales of NEXLETOL and NEXLIZET. ā a. Collaboration Revenue ā The Company has entered into an agreement related to its activities to develop, manufacture, and commercialize its product candidates. The Company earns collaboration revenue in connection with a collaboration agreement to develop and/or commercialize product candidates where the Company deems the collaborator to be the customer. Revenue is recognized when (or as) the Company satisfies performance obligations under the terms of a contract. Depending on the terms of the arrangement, the Company may defer the recognition of all or a portion of the consideration received as the performance obligations are satisfied. ā The collaboration agreements may require the Company to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In an agreement involving multiple goods or services promised to be transferred to a customer, the Company must assess, at the inception of the contract, whether each promise represents a separate performance obligation (i.e., is "distinct"), or whether such promises should be combined as a single performance obligation. ā The terms of the agreement typically include consideration to be provided to the Company in the form of non-refundable up-front payments, development milestones, sales milestones, and royalties on sales of products within a respective territory. The Company recognizes regulatory and approval milestones consideration when it is probable that a future reversal is unlikely to occur. For sales based milestones and royalties based on sales of product in a territory, the Company applies the sales-based royalty exception in ASC 606-10-55-65 to all of these milestones and royalties. ā At the inception of the contract, the transaction price reflects the amount of consideration the Company expects to be entitled to in exchange for transferring promised goods or services to its customer. In the arrangement where the Company satisfies performance obligation(s) during the regulatory phase over time, the Company recognizes collaboration revenue typically using an input method on the basis of regulatory costs incurred relative to the total expected cost which determines the extent of progress toward completion. The Company reviews the estimate of the transaction price and the total expected cost each period and makes revisions to such estimates as necessary. Under contracted supply agreements with collaborators, the Company may manufacture and supply quantities of active pharmaceutical ingredient (āAPIā) or bulk tablets reasonably required by collaboration partners for the development or sale of licensed products in their respective territory. The Company recognizes revenue when the collaboration partner has obtained control of the API or bulk tablets. The Company records the costs related to the supply agreement in cost of goods sold on the condensed statements of operations and comprehensive income (loss). ā Under the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. The Company receives royalties from the commercialization of such products, and records its share of the variable consideration, representing a percentage of net product sales, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborator. The collaborator will provide the Company with estimates of its royalties for such quarterĶ¾ these estimates are reconciled to actual results in the subsequent quarter, and the royalty is adjusted accordingly, as necessary. ā b. Product Sales, Net On February 21, 2020, the Company announced that the FDA approved NEXLETOL as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. On February 26, 2020, the Company announced that the FDA approved NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. On March 30, 2020, NEXLETOL was commercially available in the U.S. through prescription and on June 4, 2020, NEXLIZET was commercially available in the U.S. through prescription. Net product sales totaled $0.6 million and $1.5 million for the three and six months ended June 30, 2020, respectively. ā The Company sells NEXLETOL and NEXLIZET to wholesalers in the U.S and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customersā distribution facilities, or free on board (āFOBā) destination, the terms of which are designated in the contract. ā Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Given the early stage of the Companyās commercial operations it has provided constraint of its variable consideration due to its potential consumption trends. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. ā Liabilities for co-pay assistance, expected product returns, rebates, and distributor fees are classified as āOther accrued liabilitiesā in the condensed balance sheets. Discounts, such as prompt pay discounts, and chargebacks are recorded as a reduction to trade accounts receivable, which is included in āOther prepaid and current assetsā in the condensed balance sheets. ā Forms of Variable Consideration ā Rebates and Chargebacks: ā Co-pay assistance: ā Distribution Fees: ā Product Returns: ā Discounts: |
Recently Implemented Accounting Pronouncements | Recently Implemented Accounting Pronouncements ā In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (āASUā) 2016-13 which requires financial instruments to be recognized at an estimate of current expected credit losses. As part of the ASU, financial assets measured at amortized cost will be presented at the net amount expected to be collected. In addition, companies will recognize an allowance for credit losses on available-for-sale investments rather than reducing the amortized cost in an other-than-temporary impairment. The Company has chosen the practical expedient to exclude accrued interest from both the fair value and the amortized cost basis of available-for-sale debt securities in identifying and measuring an impairment. The Company adopted the standard on January 1, 2020. The adoption of this standard did not have a material impact on the Company's balance sheets, statements of operations or statements of cash flows. ā In August 2018, the FASB issued ASU 2018-15 which includes provisions to clarify customer's accounting for implementation costs incurred in a cloud computing arrangement. Under the updated guidance, a customer in a cloud computing arrangement that is a service contract should follow the internal-use software guidance to determine how to account for costs incurred in implementation. The updated guidance also requires certain classification on the balance sheets, statements of operations and statements of cash flows as well as additional quantitative and qualitative disclosures. The Company adopted the standard effective January 1, 2020 and has chosen to adopt the standard prospectively. Implementation costs for cloud computing arrangements are capitalized in "Other prepaid and current assets" on the Company's balance sheets. The adoption of this standard did not have a material impact to the Company's balance sheets, statements of operations or statements of cash flows. ā There have been no other material changes to the significant accounting policies previously disclosed in the Companyās Annual Report on Form 10-K for the fiscal year ended December 31, 2019. |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventories | |
Schedule of Inventories | ā ā ā ā ā ā ā ā ā June 30, 2020 December 31, 2019 Raw materials ā $ 4,961 ā $ ā Work in process ā 2,869 ā ā Finished goods ā 418 ā ā ā ā $ 8,248 ā $ ā |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Investments | |
Schedule of Company's cash equivalents and Short-term investments | ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā June 30, 2020 ā ā ā Gross Gross Estimated ā ā Amortized ā Unrealized ā Unrealized ā Fair ā Cost Gains Losses Value ā ā (in thousands) Cash equivalents: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 287,632 ā $ ā ā $ ā ā $ 287,632 Short-term investments: ā ā ā ā ā ā ā ā ā ā ā ā Commercial paper ā 2,247 ā ā ā ā ā 2,247 Total ā $ 289,879 ā $ ā ā $ ā ā $ 289,879 ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā December 31, 2019 ā ā ā Gross Gross Estimated ā ā Amortized ā Unrealized ā Unrealized ā Fair ā Cost Gains Losses Value ā ā (in thousands) Cash equivalents: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 20,970 ā $ ā ā $ ā ā $ 20,970 U.S. treasury notes ā ā 2,497 ā ā ā ā ā ā ā ā 2,497 Commercial paper ā ā 4,494 ā ā ā ā ā ā ā ā 4,494 Short-term investments: ā ā ā ā ā ā ā ā ā ā ā ā Certificates of deposit ā ā 245 ā ā ā ā ā ā ā ā 245 U.S treasury notes ā 29,155 ā 23 ā ā ā 29,178 Commercial paper ā 5,228 ā ā ā ā ā 5,228 Total ā $ 62,589 ā $ 23 ā $ ā ā $ 62,612 ā |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurements | |
Schedule of the Company's financial assets and liabilities measured at fair value on a recurring basis | ā ā ā ā ā ā ā ā ā ā ā ā ā ā Description Total Level 1 Level 2 Level 3 ā ā (in thousands) June 30, 2020 ā ā ā ā ā ā ā ā ā ā ā ā Assets: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 287,632 ā $ 287,632 ā $ ā ā $ ā Investments: ā ā ā ā ā ā ā ā ā ā ā ā Commercial paper ā 2,247 ā ā ā 2,247 ā ā Total assets at fair value ā $ 289,879 ā $ 287,632 ā $ 2,247 ā $ ā December 31, 2019 ā ā ā ā ā ā ā ā ā ā ā ā Assets: ā ā ā ā ā ā ā ā ā ā ā ā Money market funds ā $ 20,970 ā $ 20,970 ā $ ā ā $ ā Investments: ā ā ā ā ā ā ā ā ā ā ā ā Certificates of deposit ā 245 ā 245 ā ā ā ā U.S. treasury notes ā 31,675 ā 31,675 ā ā ā ā Commercial paper ā 9,722 ā ā ā 9,722 ā ā Total assets at fair value ā $ 62,612 ā $ 52,890 ā $ 9,722 ā $ ā ā |
Liability Related to the Reve_2
Liability Related to the Revenue Interest Purchase Agreement (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Liability Related to the Revenue Interest Purchase Agreement | |
Summary of revenue interest liability activity during the period | ā ā ā ā ā ā (in thousands) Revenue interest liability at December 31, 2019 ā $ 132,544 Oberland funding for regulatory approval of NEXLETOL ā 25,000 Interest expense recognized ā 8,811 Revenue Interests payments ā ā (64) Revenue interest liability at June 30, 2020 ā $ 166,291 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Other Accrued Liabilities | |
Schedule of other accrued liabilities | ā ā ā ā ā ā ā ā ā June 30, December 31, ā ā 2020 ā 2019 ā ā (in thousands) Accrued compensation ā $ 10,868 ā $ 7,818 Accrued professional fees ā 5,864 ā 3,842 Accrued inventory ā 1,771 ā ā Accrued other ā 3,405 ā 211 Total other accrued liabilities ā $ 21,908 ā $ 11,871 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Stock Compensation | |
Summary of activity relating to the Company's options to purchase common stock | ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā Weighted-Average ā Weighted-Average ā ā ā ā ā ā ā Exercise ā Remaining ā Aggregate ā ā Number of ā Price ā Contractual ā Intrinsic ā Options Per Share Term (Years) Value ā ā ā ā ā ā ā ā ā (in thousands) Outstanding at December 31, 2019 4,677,929 ā $ 39.31 6.82 ā $ 109,054 Granted 234,940 ā $ 61.14 ā ā ā ā ā Forfeited or expired (134,945) ā $ 56.38 ā ā ā ā ā Exercised (200,157) ā $ 23.74 ā ā ā ā ā Outstanding at June 30, 2020 4,577,767 ā $ 40.61 6.10 ā $ 72,396 ā |
Summary of information about the Company's stock option plan | ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā Weighted-Average ā Weighted-Average ā ā ā ā ā ā ā Exercise ā Remaining ā Aggregate ā ā Number of ā Price ā Contractual ā Intrinsic ā Options Per Share Term (Years) Value ā ā ā ā ā ā ā ā ā (in thousands) Vested and expected to vest at June 30, 2020 4,577,767 ā $ 40.61 6.10 ā $ 72,396 Exercisable at June 30, 2020 3,195,452 ā $ 35.88 5.12 ā $ 65,786 |
Summary of activity relating to the Company's RSUs | ā ā ā ā ā ā ā ā ā Weighted-Average ā ā Number of ā Fair Value Per ā ā RSUs ā Share Outstanding and unvested at December 31, 2019 245,966 ā $ 44.45 Granted 322,167 ā $ 52.82 Forfeited ā (28,921) ā $ 44.70 Vested (53,587) ā $ 51.98 Outstanding and unvested at June 30, 2020 485,625 ā $ 49.16 ā |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Leases | |
Schedule of future maturities of operating lease liabilities | The following table summarizes the Companyās future maturities of operating lease liabilities as of June 30, 2020: ā ā ā ā ā ā (in thousands) 2020 (remaining) ā $ 1,209 2021 ā 2,380 2022 ā 2,333 2023 ā 584 2024 ā ā Total lease payments ā 6,506 Less imputed interest ā 307 Total ā $ 6,199 |
Net Income (Loss) Per Common _2
Net Income (Loss) Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Net Income (Loss) Per Common Share | |
Summary of the calculation of basic and diluted net income (loss) per share | ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the three months ended , ā For the six months ended , ā June 30, June 30, June 30, June 30, ā ā 2020 ā 2019 ā 2020 ā 2019 Net income (loss) (in thousands) ā $ 124,611 ā $ (54,221) ā $ 46,362 ā $ 33,158 ā ā ā ā ā ā ā ā ā ā ā ā ā Weighted average common shares outstanding - basic ā 27,665,728 ā 26,968,818 ā 27,592,479 ā 26,906,149 Effect of dilutive shares: ā ā ā ā ā ā ā ā Warrants for common stock ā ā ā ā ā ā ā 4,230 Common shares under option ā 1,139,280 ā ā ā 1,291,353 ā 1,607,093 Unvested RSUs ā 49,437 ā ā ā 64,226 ā 543 Dilutive shares ā 1,188,717 ā ā ā 1,355,579 ā 1,611,866 Weighted average common shares outstanding - diluted ā 28,854,445 ā 26,968,818 ā 28,948,058 ā 28,518,015 ā ā ā ā ā ā ā ā ā ā ā ā ā Net income (loss) per common share - basic ā $ 4.50 ā $ (2.01) ā $ 1.68 ā $ 1.23 Net income (loss) per common share - diluted ā $ 4.32 ā $ (2.01) ā $ 1.60 ā $ 1.16 |
Schedule of anti-dilutive shares excluded from calculation of diluted net income (loss) per share | ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the three months ended , ā For the six months ended , ā June 30, ā June 30, ā June 30, ā June 30, ā 2020 2019 2020 2019 Common shares under option ā 2,427,074 ā 5,322,686 ā 2,391,374 ā 2,511,692 Unvested RSUs ā 295,423 ā 83,778 ā 190,565 ā 77,653 Total potential dilutive shares ā 2,722,497 ā 5,406,464 ā 2,581,939 ā 2,589,345 |
Statements of Cash Flows (Table
Statements of Cash Flows (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Statements of Cash Flows. | |
Schedule of reconciliation of cash and cash equivalents and restricted cash presented on the condensed balance sheets to the same amounts presented on the condensed statements of cash flows | ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā June 30, ā June 30, ā December 31, ā December 31, ā 2020 2019 2019 2018 Cash and cash equivalents ā $ 298,489 ā $ 274,344 ā $ 166,130 ā $ 36,973 Restricted cash ā ā ā 928 ā 928 ā ā Total cash and cash equivalents and restricted cash shown on the condensed statements of cash flows ā $ 298,489 ā $ 275,272 ā $ 167,058 ā $ 36,973 |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) - USD ($) $ in Millions | Apr. 17, 2020 | Jun. 30, 2020 |
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | ||
The Company and Basis of Presentation | ||
Upfront cash payment | $ 60 | |
Potential additional future payments | $ 450 | |
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | Minimum | ||
The Company and Basis of Presentation | ||
Percentage of royalties to be received on the net sales | 15.00% | |
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | Maximum | ||
The Company and Basis of Presentation | ||
Percentage of royalties to be received on the net sales | 30.00% | |
Amended License and Collaboration Agreement | Daiichi Sankyo Europe GmbH ("DSE") | ||
The Company and Basis of Presentation | ||
Proceeds received upon completion of NUSTENDI MAA transfer | $ 150 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)customer | Jun. 30, 2019USD ($) | |
Product Sales, Net | ||||
Revenue | $ 212,236 | $ 982 | $ 214,076 | $ 146,401 |
Product sales, net | ||||
Product Sales, Net | ||||
Revenue | $ 609 | $ 1,467 | ||
Trade Receivables | Customer Concentration Risk | ||||
Concentration of Risk | ||||
Number of major customers | customer | 1 |
Collaborations with Third Par_2
Collaborations with Third Parties (Details) - USD ($) $ in Thousands | Apr. 17, 2020 | Jan. 02, 2019 | Jun. 30, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 |
Collaborations with Third Parties | |||||||
Total Revenues | $ 212,236 | $ 982 | $ 214,076 | $ 146,401 | |||
Collaboration revenue | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | 211,627 | 982 | 212,609 | 146,401 | |||
Daiichi Sankyo Europe GmbH ("DSE") | Regulatory performance obligations | |||||||
Collaborations with Third Parties | |||||||
Upfront payment, revenue recognized | 700 | $ 1,000 | 1,600 | $ 146,400 | |||
Daiichi Sankyo Europe GmbH ("DSE") | NUSTENDI, MAA | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | 150,000 | 150,000 | |||||
Daiichi Sankyo Europe GmbH ("DSE") | NILEMDO and NUSTENDI, sales of bulk tablets | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | 1,000 | 1,000 | |||||
License and Collaboration Agreement | Daiichi Sankyo Europe GmbH ("DSE") | |||||||
Collaborations with Third Parties | |||||||
Upfront cash payment | $ 150,000 | ||||||
Cash payment to the Company upon first commercial sales in the DSE Territory | $ 150,000 | ||||||
License and Collaboration Agreement | Daiichi Sankyo Europe GmbH ("DSE") | Minimum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 15.00% | ||||||
License and Collaboration Agreement | Daiichi Sankyo Europe GmbH ("DSE") | Maximum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 25.00% | ||||||
Amended License and Collaboration Agreement | Daiichi Sankyo Europe GmbH ("DSE") | |||||||
Collaborations with Third Parties | |||||||
Proceeds received upon completion of NUSTENDI MAA transfer | $ 150,000 | ||||||
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | |||||||
Collaborations with Third Parties | |||||||
Upfront cash payment | $ 60,000 | ||||||
Potential additional future payments | $ 450,000 | ||||||
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | Minimum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 15.00% | ||||||
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | Maximum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 30.00% | ||||||
Milestone payment, first JNDA submissions | $ 20,000 | ||||||
Milestone payment, first NHI Price Listing for NEXLETOL in the Otsuka Territory | 70,000 | ||||||
Milestone payment, achievement of the primary MACE in the CLEAR Outcomes study and CV risk reduction rate on the U.S. label | 50,000 | ||||||
Milestone payments related to total net sales achievements | $ 310,000 | ||||||
Exclusive Development and Commercialization Rights to NEXLETOL and NEXLIZET Tablets | Otsuka Pharmaceutical Co, Ltd. | Collaboration revenue | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | $ 60,000 | $ 60,000 |
Inventories (Details)
Inventories (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Inventories | |
Raw materials | $ 4,961 |
Work in process | 2,869 |
Finished goods | 418 |
Total Inventory | $ 8,248 |
Inventory supplies of NEXLETOL and NEXLIZET | |
Inventories | |
Initial agreement term | 3 years |
Renewal periods | 1 year |
Rolling period for minimum purchase order commitments | 12 months |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Investments | |||||
Total, Amortized Cost | $ 289,879 | $ 289,879 | $ 62,589 | ||
Gross Unrealized Gains | 23 | ||||
Total, Estimated Fair Value | 289,879 | 289,879 | 62,612 | ||
Accretion of premiums and discounts on investments | (93) | $ (121) | |||
Other income, net | 81 | $ 1,077 | 449 | 1,527 | |
Allowances for credit losses | 0 | 0 | |||
Accrued interest receivables | 0 | 0 | |||
Other income, net | |||||
Investments | |||||
Interest income on investments | 100 | 1,000 | 500 | 1,400 | |
Accretion of premiums and discounts on investments | 100 | 100 | |||
Other income, net | Maximum | |||||
Investments | |||||
Accretion of premiums and discounts on investments | 100 | 100 | |||
Reclassification out of accumulated other comprehensive income (loss) | |||||
Investments | |||||
Other income, net | 0 | $ 0 | 0 | $ 0 | |
Short-term investments | Certificates of deposit | |||||
Investments | |||||
Investments, Amortized Cost | 245 | ||||
Investments, Estimated Fair Value | 245 | ||||
Short-term investments | U.S. treasury notes | |||||
Investments | |||||
Investments, Amortized Cost | 29,155 | ||||
Gross Unrealized Gains | 23 | ||||
Investments, Estimated Fair Value | 29,178 | ||||
Short-term investments | Commercial paper | |||||
Investments | |||||
Investments, Amortized Cost | 2,247 | 2,247 | 5,228 | ||
Investments, Estimated Fair Value | 2,247 | 2,247 | 5,228 | ||
Money market funds | |||||
Investments | |||||
Cash equivalents | 287,632 | 287,632 | 20,970 | ||
Cash equivalents, Estimated Fair Value | $ 287,632 | $ 287,632 | 20,970 | ||
U.S. treasury notes | |||||
Investments | |||||
Cash equivalents | 2,497 | ||||
Cash equivalents, Estimated Fair Value | 2,497 | ||||
Commercial paper | |||||
Investments | |||||
Cash equivalents | 4,494 | ||||
Cash equivalents, Estimated Fair Value | $ 4,494 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Assets: | ||
Total, Estimated Fair Value | $ 289,879 | $ 62,612 |
Recurring fair value measurement | ||
Assets: | ||
Money market funds | 287,632 | 20,970 |
Total, Estimated Fair Value | 289,879 | 62,612 |
Recurring fair value measurement | Certificates of deposit | ||
Assets: | ||
Investments, Fair Value Disclosure | 245 | |
Recurring fair value measurement | U.S. treasury notes | ||
Assets: | ||
Investments, Fair Value Disclosure | 31,675 | |
Recurring fair value measurement | Commercial paper | ||
Assets: | ||
Investments, Fair Value Disclosure | 2,247 | 9,722 |
Recurring fair value measurement | Level 1 | ||
Assets: | ||
Money market funds | 287,632 | 20,970 |
Total, Estimated Fair Value | 287,632 | 52,890 |
Recurring fair value measurement | Level 1 | Certificates of deposit | ||
Assets: | ||
Investments, Fair Value Disclosure | 245 | |
Recurring fair value measurement | Level 1 | U.S. treasury notes | ||
Assets: | ||
Investments, Fair Value Disclosure | 31,675 | |
Recurring fair value measurement | Level 2 | ||
Assets: | ||
Total, Estimated Fair Value | 2,247 | 9,722 |
Recurring fair value measurement | Level 2 | Commercial paper | ||
Assets: | ||
Investments, Fair Value Disclosure | $ 2,247 | $ 9,722 |
Liability Related to the Reve_3
Liability Related to the Revenue Interest Purchase Agreement (Details) - USD ($) $ in Thousands | Jun. 26, 2019 | Mar. 31, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2020 | Jun. 30, 2019 |
Liability Related to the Revenue Interest Purchase Agreement | ||||||
Proceeds from revenue interest liability | $ 25,000 | $ 124,649 | ||||
Interest expense | $ 4,640 | 8,811 | ||||
Summary of activity in revenue interest liability | ||||||
Revenue interest liability at December 31, 2019 | 132,544 | |||||
Revenue Interests payments | (64) | |||||
Revenue interest liability at June 30, 2020 | 166,291 | 166,291 | ||||
Revenue Interest Purchase Agreement (RIPA) | ||||||
Liability Related to the Revenue Interest Purchase Agreement | ||||||
Capitalized issuance costs | 500 | |||||
Interest expense | 4,600 | 8,800 | ||||
Summary of activity in revenue interest liability | ||||||
Oberland funding for regulatory approval of NEXLETOL | 25,000 | |||||
Interest expense recognized | 8,811 | |||||
Revenue interest liability at June 30, 2020 | $ 166,300 | $ 166,300 | ||||
Revenue Interest Purchase Agreement (RIPA) | Oberland | ||||||
Liability Related to the Revenue Interest Purchase Agreement | ||||||
Proceeds from revenue interest liability | $ 25,000 | |||||
Gross proceeds from revenue interest liability | $ 125,000 | |||||
Total amount of subsequent installment, subject to RIPA terms and conditions | 75,000 | |||||
Amount of subsequent installment, subject to regulatory approval | 25,000 | |||||
Amount of subsequent installment, subject to achievement of Sales Threshold | 50,000 | |||||
Milestone amount for worldwide sales to receive the Third Payment | $ 100,000 | |||||
Consecutive number of months sales must be at or above milestone amount | 6 months | |||||
Revenue interest rate which will take effect if annual net sales equals or exceeds the Sales Threshold by December 31, 2021 | 2.50% | |||||
Initial revenue interest rate | 7.50% | |||||
Minimum amount of annual net sales to qualify for reduced revenue interest rate by December 31, 2021 | $ 350,000 | |||||
Percentage of invested capital received by December 31, 2024, to qualify for second reduced revenue interest rate | 100.00% | |||||
Revenue interest rate if annual net sales equal or exceed the Sales Threshold and if the Purchasers receive 100% of their invested capital by December 31, 2024 | 0.40% | |||||
Percentage of increase in royalty rate upon drawdown of third payment | 33.33% | |||||
Percentage of revenue interests payment on which agreement terminates | 195.00% | |||||
Percentage of revenue interests payment on which agreement terminates, if prior to the anniversary of the closing date, if put option is exercised | 120.00% | |||||
Percentage of revenue interests payment on which agreement terminates, prior to the third anniversary of the closing date, if put option is exercised | 175.00% | |||||
Percentage of revenue interests payment on which agreement terminates, after the third anniversary of the closing date, if put option is exercised | 195.00% | |||||
Capitalized issuance costs | $ 600 | |||||
Effective annual imputed interest rate (as a percent) | 10.10% |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Other Accrued Liabilities | ||
Accrued compensation | $ 10,868 | $ 7,818 |
Accrued professional fees | 5,864 | 3,842 |
Accrued inventory | 1,771 | |
Accrued other | 3,405 | 211 |
Total other accrued liabilities | $ 21,908 | $ 11,871 |
Stock Compensation - ESPP (Deta
Stock Compensation - ESPP (Details) - 2020 ESPP | 1 Months Ended |
Apr. 30, 2020USD ($) | |
Employee Stock Purchase Plan | |
Maximum annual contributions per employee, as a percentage of base salary | 10.00% |
Amount of maximum annual contributions per employee | $ 25,000 |
Purchase discount | 15.00% |
Duration of offering periods | 6 months |
Stock Compensation - Stock Opti
Stock Compensation - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Number of Options | |||||
Outstanding at the beginning of period (in shares) | 4,677,929 | ||||
Granted (in shares) | 234,940 | ||||
Forfeited or expired (in shares) | (134,945) | ||||
Exercised (in shares) | (200,157) | ||||
Outstanding at the end of the period (in shares) | 4,577,767 | 4,577,767 | 4,677,929 | ||
Vested and expected to vest (in shares) | 4,577,767 | 4,577,767 | |||
Exercisable (in shares) | 3,195,452 | 3,195,452 | |||
Weighted-Average Exercise Price Per Share | |||||
Outstanding at the beginning of period (in dollars per share) | $ 39.31 | ||||
Granted (in dollars per share) | 61.14 | ||||
Forfeited or expired (in dollars per share) | 56.38 | ||||
Exercised (in dollars per share) | 23.74 | ||||
Outstanding at the end of the period (in dollars per share) | $ 40.61 | 40.61 | $ 39.31 | ||
Vested and expected to vest (in dollars per share) | 40.61 | 40.61 | |||
Exercisable (in dollars per share) | $ 35.88 | $ 35.88 | |||
Weighted-Average Remaining Contractual Term (Years) | |||||
Outstanding | 6 years 1 month 6 days | 6 years 9 months 25 days | |||
Vested and expected to vest | 6 years 1 month 6 days | ||||
Exercisable | 5 years 1 month 13 days | ||||
Aggregate Intrinsic Value | |||||
Outstanding | $ 72,396 | $ 72,396 | $ 109,054 | ||
Vested and expected to vest | 72,396 | 72,396 | |||
Exercisable | 65,786 | 65,786 | |||
Stock options | |||||
Additional disclosures | |||||
Stock-based compensation expense | 5,500 | $ 6,200 | 11,100 | $ 12,600 | |
Unrecognized stock-based compensation expense, options | 44,000 | $ 44,000 | |||
Weighted-average period over which remaining unrecognized compensation cost will be recognized | 2 years 4 months 24 days | ||||
Stock-based compensation capitalized into inventory | $ 300 | $ 500 |
Stock Compensation - RSUs (Deta
Stock Compensation - RSUs (Details) - RSUs - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Number of RSUs | ||||
Outstanding and unvested at the beginning of period (in shares) | 245,966 | |||
Granted (in shares) | 322,167 | |||
Forfeited or expired (in shares) | (28,921) | |||
Vested (in shares) | (53,587) | |||
Outstanding and unvested at the ending of period (in shares) | 485,625 | 485,625 | ||
Weighted-Average Fair Value Per Share | ||||
Outstanding and unvested at the beginning of period (in dollars per share) | $ 44.45 | |||
Granted (in dollars per share) | 52.82 | |||
Forfeited or expired (in dollars per share) | 44.70 | |||
Vested (in dollars per share) | 51.98 | |||
Outstanding and unvested at the at the end of the period (in dollars per share) | $ 49.16 | $ 49.16 | ||
Stock-based compensation expense | $ 1.8 | $ 0.4 | $ 3.3 | $ 0.6 |
Unrecognized stock-based compensation expense, RSUs | 21.5 | $ 21.5 | ||
Weighted-average period over which remaining unrecognized compensation cost will be recognized | 3 years 2 months 12 days | |||
Stock-based compensation capitalized into inventory | $ 0.1 | $ 0.1 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Leases | ||||
Increase in right-of-use assets | $ 4,600 | |||
Increase in operating lease liabilities | 4,600 | |||
Operating lease costs | $ 600 | 800 | $ 100 | |
Cash paid for the amounts included in the measurement of lease liabilities | $ 600 | $ 800 | 100 | |
Weighted-average remaining lease term of operating leases | 2 years 8 months 12 days | 2 years 8 months 12 days | ||
Weighted average discount rate | 3.60% | 3.60% | ||
Right of use assets obtained in exchange for lease obligations | $ 0 | $ 0 | ||
Future maturities of operating lease liabilities | ||||
2020 (remaining) | $ 1,209 | 1,209 | ||
2021 | 2,380 | 2,380 | ||
2022 | 2,333 | 2,333 | ||
2023 | 584 | 584 | ||
Total lease payments | 6,506 | 6,506 | ||
Less imputed interest | 307 | 307 | ||
Total | $ 6,199 | $ 6,199 | ||
Maximum | ||||
Leases | ||||
Operating lease costs | $ 100 | |||
Cash paid for the amounts included in the measurement of lease liabilities | $ 100 | |||
Principal executive offices | ||||
Leases | ||||
Operating lease term | 5 years | 5 years | ||
Automobile leases and IT equipment leases | ||||
Leases | ||||
Operating lease term | 3 years | 3 years |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Provision for income taxes | ||||
Provision for income taxes | $ 0 | $ 0 | $ 0 | $ 0 |
Net Income (Loss) Per Common _3
Net Income (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Net Income (Loss) Per Common Share | ||||||
Net income (loss) | $ 124,611 | $ (78,249) | $ (54,221) | $ 87,379 | $ 46,362 | $ 33,158 |
Weighted average common shares outstanding - basic | 27,665,728 | 26,968,818 | 27,592,479 | 26,906,149 | ||
Dilutive shares | 1,188,717 | 1,355,579 | 1,611,866 | |||
Weighted average common shares outstanding - diluted | 28,854,445 | 26,968,818 | 28,948,058 | 28,518,015 | ||
Net income (loss) per common share - basic | $ 4.50 | $ (2.01) | $ 1.68 | $ 1.23 | ||
Net income (loss) per common share - diluted | $ 4.32 | $ (2.01) | $ 1.60 | $ 1.16 | ||
Total potential dilutive shares | 2,722,497 | 5,406,464 | 2,581,939 | 2,589,345 | ||
Warrants for common stock | ||||||
Net Income (Loss) Per Common Share | ||||||
Dilutive shares | 4,230 | |||||
Stock options | ||||||
Net Income (Loss) Per Common Share | ||||||
Dilutive shares | 1,139,280 | 1,291,353 | 1,607,093 | |||
Total potential dilutive shares | 2,427,074 | 5,322,686 | 2,391,374 | 2,511,692 | ||
Unvested RSUs | ||||||
Net Income (Loss) Per Common Share | ||||||
Dilutive shares | 49,437 | 64,226 | 543 | |||
Total potential dilutive shares | 295,423 | 83,778 | 190,565 | 77,653 |
Statements of Cash Flows (Detai
Statements of Cash Flows (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | Dec. 31, 2018 |
Statements of Cash Flows. | ||||
Cash and cash equivalents | $ 298,489 | $ 166,130 | $ 274,344 | $ 36,973 |
Restricted cash | 928 | 928 | ||
Total cash and cash equivalents and restricted cash shown on the Condensed Statements of Cash Flows | $ 298,489 | $ 167,058 | $ 275,272 | $ 36,973 |