Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36306 | |
Entity Registrant Name | Eagle Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-8179278 | |
Entity Address, Address Line One | 50 Tice Boulevard | |
Entity Address, Address Line Two | Suite 315 | |
Entity Address, City or Town | Woodcliff Lake | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07677 | |
City Area Code | (201) | |
Local Phone Number | 326-5300 | |
Title of 12(b) Security | Common stock, $0.001 par value per share | |
Trading Symbol | EGRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 13,097,113 | |
Entity Central Index Key | 0000827871 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 108,717 | $ 103,155 |
Accounts receivable, net | 52,659 | 50,678 |
Inventories | 8,294 | 8,075 |
Prepaid expenses and other current assets | 5,834 | 4,157 |
Total current assets | 175,504 | 166,065 |
Property and equipment, net | 1,967 | 2,077 |
Intangible assets, net | 11,505 | 12,917 |
Goodwill | 39,743 | 39,743 |
Deferred tax asset, net | 14,061 | 15,180 |
Other assets | 21,462 | 17,208 |
Total assets | 264,242 | 253,190 |
Current liabilities: | ||
Accounts payable | 11,136 | 6,268 |
Accrued expenses and other liabilities | 25,528 | 23,817 |
Current portion of long-term debt | 8,000 | 8,000 |
Total current liabilities | 44,664 | 38,085 |
Other long-term liabilities | 3,360 | 3,959 |
Long-term debt, less current portion | 21,371 | 25,135 |
Total liabilities | 69,395 | 67,179 |
Commitments and Contingencies | ||
Stockholders' equity: | ||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of June 30, 2021 and December 31, 2020 | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 16,879,974 and 16,739,203 shares issued as of June 30, 2021 and December 31, 2020, respectively | 17 | 17 |
Additional paid in capital | 316,249 | 305,403 |
Accumulated other comprehensive loss | (904) | 0 |
Retained earnings | 87,680 | 84,489 |
Treasury stock, at cost, 3,782,861 and 3,682,176 shares as of June 30, 2021 and December 31, 2020, respectively | (208,195) | (203,898) |
Total stockholders' equity | 194,847 | 186,011 |
Total liabilities and stockholders' equity | $ 264,242 | $ 253,190 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized (in shares) | 1,500,000 | 1,500,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 16,879,974 | 16,739,203 |
Treasury stock (in shares) | 3,782,861 | 3,682,176 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 48,124 | $ 41,938 | $ 89,373 | $ 87,958 |
Operating expenses: | ||||
Cost of product sales | 7,907 | 10,313 | 16,349 | 15,078 |
Cost of royalty revenue | 2,850 | 2,822 | 5,263 | 5,860 |
Research and development | 9,911 | 7,135 | 24,199 | 16,562 |
Selling, general and administrative | 16,636 | 17,959 | 36,515 | 42,714 |
Total operating expenses | 37,304 | 38,229 | 82,326 | 80,214 |
Income from operations | 10,820 | 3,709 | 7,047 | 7,744 |
Interest income | 163 | 150 | 198 | 496 |
Interest expense | (422) | (786) | (844) | (1,675) |
Other (expense) income | (5,013) | 2,300 | 487 | (4,200) |
Total other (expense) income, net | (5,272) | 1,664 | (159) | (5,379) |
Income before income tax provision | 5,548 | 5,373 | 6,888 | 2,365 |
Income tax provision | (1,936) | (5,629) | (3,697) | (5,492) |
Net Income (Loss) | $ 3,612 | $ (256) | $ 3,191 | $ (3,127) |
Earnings (Loss) per share attributable to common stockholders: | ||||
Basic (in dollars per share) | $ 0.28 | $ (0.02) | $ 0.24 | $ (0.23) |
Diluted (in dollars per share) | $ 0.27 | $ (0.02) | $ 0.24 | $ (0.23) |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 13,108,998 | 13,664,951 | 13,116,370 | 13,666,279 |
Diluted (in shares) | 13,262,164 | 13,664,951 | 13,293,920 | 13,666,279 |
Product sales, net | ||||
Revenue: | ||||
Total revenue | $ 19,621 | $ 14,376 | $ 36,741 | $ 32,070 |
Royalty revenue | ||||
Revenue: | ||||
Total revenue | $ 28,503 | $ 27,562 | $ 52,632 | $ 55,888 |
Statement of Comprehensive Inco
Statement of Comprehensive Income (Statement) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 3,612 | $ (256) | $ 3,191 | $ (3,127) |
Other comprehensive loss, net of tax: | ||||
Unrealized loss for convertible promissory note | (904) | 0 | (904) | 0 |
Total other comprehensive loss | (904) | 0 | (904) | 0 |
Comprehensive income (loss) | $ 2,708 | $ (256) | $ 2,287 | $ (3,127) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Treasury Stock | Accumulated Other Comprehensive Loss | Retained Earnings |
Beginning balance (in shares) at Dec. 31, 2019 | 16,538,000 | |||||
Beginning balance at Dec. 31, 2019 | $ 179,174 | $ 17 | $ 278,518 | $ (171,861) | $ 72,500 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 13,713 | 13,713 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 38,951 | 39,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 513 | 513 | ||||
Payment of employee withholding tax upon vesting of stock-based awards | (1,310) | (1,310) | ||||
Issuance of common stock related to vesting of restricted stock units (in shares) | 45,000 | |||||
Common stock repurchases | (4,999) | (4,999) | ||||
Other comprehensive loss | 0 | |||||
Net income (loss) | (3,127) | (3,127) | ||||
Ending balance (in shares) at Jun. 30, 2020 | 16,622,000 | |||||
Ending balance at Jun. 30, 2020 | 183,964 | $ 17 | 291,434 | (176,860) | 69,373 | |
Beginning balance (in shares) at Mar. 31, 2020 | 16,598,000 | |||||
Beginning balance at Mar. 31, 2020 | 181,830 | $ 17 | 285,044 | (172,860) | 69,629 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 6,241 | 6,241 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 23,000 | |||||
Issuance of common stock upon exercise of stock option grants | 183 | 183 | ||||
Payment of employee withholding tax upon vesting of stock-based awards | (34) | (34) | ||||
Issuance of common stock related to vesting of restricted stock units (in shares) | 1,000 | |||||
Common stock repurchases | (4,000) | (4,000) | ||||
Other comprehensive loss | 0 | |||||
Net income (loss) | (256) | (256) | ||||
Ending balance (in shares) at Jun. 30, 2020 | 16,622,000 | |||||
Ending balance at Jun. 30, 2020 | 183,964 | $ 17 | 291,434 | (176,860) | 69,373 | |
Beginning balance (in shares) at Dec. 31, 2020 | 16,739,000 | |||||
Beginning balance at Dec. 31, 2020 | 186,011 | $ 17 | 305,403 | (203,898) | $ 0 | 84,489 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 10,789 | 10,789 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 94,328 | 78,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 1,608 | 1,608 | ||||
Issuance of common stock related to vesting of restricted stock units (in shares) | 63,000 | |||||
Issuance of common stock related to vesting of restricted stock units | (1,551) | (1,551) | ||||
Common stock repurchases | (4,297) | (4,297) | ||||
Other comprehensive loss | (904) | (904) | ||||
Net income (loss) | 3,191 | 3,191 | ||||
Ending balance (in shares) at Jun. 30, 2021 | 16,880,000 | |||||
Ending balance at Jun. 30, 2021 | 194,847 | $ 17 | 316,249 | (208,195) | (904) | 87,680 |
Beginning balance (in shares) at Mar. 31, 2021 | 16,858,000 | |||||
Beginning balance at Mar. 31, 2021 | 191,078 | $ 17 | 312,323 | (205,330) | 0 | 84,068 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 4,281 | 4,281 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 22,000 | |||||
Issuance of common stock upon exercise of stock option grants | (355) | (355) | ||||
Common stock repurchases | (2,865) | (2,865) | ||||
Other comprehensive loss | (904) | (904) | ||||
Net income (loss) | 3,612 | 3,612 | ||||
Ending balance (in shares) at Jun. 30, 2021 | 16,880,000 | |||||
Ending balance at Jun. 30, 2021 | $ 194,847 | $ 17 | $ 316,249 | $ (208,195) | $ (904) | $ 87,680 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||||
Net income (loss) | $ 3,612 | $ (256) | $ 3,191 | $ (3,127) | |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | |||||
Deferred income taxes | 1,119 | (916) | |||
Depreciation expense | 378 | 460 | |||
Noncash operating lease expense related to right-of-use assets | 508 | 471 | |||
Amortization expense of intangible assets | 706 | 667 | 1,412 | 1,333 | |
Fair value adjustments on equity investment | (400) | 4,200 | |||
Stock-based compensation expense | 10,789 | 13,713 | |||
Convertible promissory note related credit losses | 100 | 0 | |||
Amortization of debt issuance costs | 236 | 183 | |||
Fair value adjustments related to derivative instrument | (188) | 0 | |||
Accretion of discount on convertible promissory note | (56) | 0 | |||
Changes in operating assets and liabilities which provided (used) cash: | |||||
Accounts receivable | (1,981) | 1,223 | |||
Inventories | (219) | (1,325) | |||
Prepaid expenses and other current assets | (1,802) | 9,553 | |||
Accounts payable | 4,868 | 8,246 | |||
Accrued expenses and other liabilities | 1,710 | (8,583) | |||
Other assets and other long-term liabilities, net | (594) | (1,321) | |||
Net cash provided by operating activities | 19,071 | 24,110 | |||
Cash flows from investing activities: | |||||
Purchase of equity investment security | 0 | (17,500) | |||
Purchase of property and equipment | (269) | (376) | |||
Purchase of convertible promissory note | (5,000) | 0 | |||
Net cash used in investing activities | (5,269) | (17,876) | |||
Cash flows from financing activities: | |||||
Proceeds from common stock option exercises | 1,608 | 513 | |||
Employee withholding taxes related to stock-based awards | (1,551) | (1,310) | |||
Proceeds from existing revolving credit facility | 0 | 110,000 | |||
Repayment of existing revolving credit facility | 0 | (110,000) | |||
Payment of debt | (4,000) | (2,000) | |||
Repurchases of common stock | (4,297) | (4,999) | |||
Net cash used in financing activities | (8,240) | (7,796) | |||
Net increase (decrease) in cash and cash equivalents | 5,562 | (1,562) | |||
Cash and cash equivalents at beginning of period | 103,155 | 109,775 | $ 109,775 | ||
Cash and cash equivalents at end of period | $ 108,717 | $ 108,213 | 108,717 | 108,213 | 103,155 |
Cash paid during the period for: | |||||
Income taxes, net | 4,300 | 502 | |||
Interest | 625 | 1,458 | |||
Right-of-use asset obtained in exchange for lease obligation - lease amendment | $ 0 | $ 842 | $ 855 |
Basis of Presentation and Other
Basis of Presentation and Other Company Information | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Other Company Information | Basis of Presentation and Other Company Information The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for reporting quarterly information. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. The condensed consolidated balance sheet at December 31, 2020 was derived from audited financial statements, but certain information and footnote disclosures normally included in our annual consolidated financial statements have been condensed or omitted. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the financial information for the interim periods reported have been made. Results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results for the year ending December 31, 2021 or any period thereafter. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 5, 2021. We are an integrated pharmaceutical company focused on finding ways to help medicines do more for patients. We and our collaborators have the capabilities to take a molecule from preclinical research through regulatory approval and into the marketplace, including development, manufacturing and commercialization. Our business model applies our scientific expertise, proprietary research-based insights and marketplace proficiency to identify challenging-to-treat diseases of the central nervous system or metabolic critical care therapeutic areas as well as in oncology. By focusing on patients' unmet needs, we strive to provide healthcare professionals with urgently needed treatment solutions that are designed to improve patient care and outcomes and create near- and long-term value for our stakeholders, including patients and healthcare providers and our employees, marketing partners, collaborators and investors. Our science-based business model has a proven track record with U.S. Food and Drug Administration ("FDA") approval and commercial launches of three products: Ryanodex® (dantrolene sodium) ("Ryanodex"), bendamustine ready-to-dilute ("RTD") 500ml solution ("Belrapzo"), and rapidly infused bendamustine RTD ("Bendeka"). We market our products through marketing partners and/or our internal direct sales force. We market Ryanodex and Belrapzo, and Teva Pharmaceutical Industries Ltd. ("Teva") markets Bendeka through its subsidiary Cephalon, Inc. SymBio Pharmaceuticals Limited, or SymBio, markets Treakisym, a lyophilized powder formulation of bendamustine hydrochloride, in Japan. Reflecting further expansion of our oncology portfolio, in February 2020, we received final FDA approval for Pemfexy, a branded alternative to Alimta for metastatic non-squamous non-small cell lung cancer and malignant pleural mesothelioma. We expect to launch Pemfexy in early 2022. With several pipeline projects underway and the potential for up to five product launches over the next several years, we believe we have many growth opportunities ahead. We believe that each of our pipeline projects currently has the potential to enter the market as a first-in-class, first-to-file, first-to-market or best-in-class product. In particular, we are applying our expertise to conduct novel research regarding the potential for Ryanodex to address conditions including Alzheimer’s disease, traumatic brain injury/concussion, nerve agent exposure and acute radiation syndrome. In addition, our clinical development program includes a strategic partnership with Tyme Technologies, Inc., or Tyme, for Tyme’s product candidate for the treatment of patients with pancreatic or other advanced cancers, SM-88, as well as investigations of compounds such as EA-114 (our fulvestrant product candidate) for patients with HR-positive advanced breast cancer. Other products in development include Vasopressin, our first-to-file Abbreviated New Drug Application, or ANDA, that references Endo International plc’s Vasostrict indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; and EA-111, a new chemical entity and next-generation ryanodine receptor antagonist, in an intramuscular formulation that that would allow for easier and more rapid administration in emergency situations (military and civilian). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Significant Accounting Policies Our significant accounting policies are described in the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020 and the notes thereto filed with the SEC on March 5, 2021. Since the date of those consolidated financial statements, there have been no material changes to our significant accounting policies other than as listed below. Significant Risks and Uncertainties In response to the ongoing COVID-19 pandemic, we have taken and continue to take active measures designed to address and mitigate the impact of the COVID-19 pandemic on our business, such as remote working policies, facilitating management’s periodic communication to address employee and business concerns and providing frequent updates to our Board of Directors (“Board”). During the second quarter of 2021, we implemented a plan to reopen our office to allow employees to return to the office, with a focus on employee safety and optimal work environment. Our management continues to monitor and evaluate such plans as the pandemic continues to evolve. We anticipate that the COVID-19 pandemic may also have an impact on the clinical development timelines for certain of our clinical programs. We also anticipate that the COVID-19 pandemic may have an impact on our supply chain. The COVID-19 pandemic and associated lockdowns have resulted in a decrease in healthcare utilization broadly and specifically lead to a continuing reduction in the utilization of physician-administered oncology products including Belrapzo and Bendeka. In addition, the COVID-19 pandemic has delayed the timing of ongoing litigation, including the litigation with Par (as defined below) with respect to Vasopressin, and we anticipate that such delays will continue for the duration of the pandemic. The extent to which the COVID-19 pandemic will continue to impact our business, clinical development and regulatory efforts, supply chain and sales efforts, corporate development objectives and the value of, and market for, our common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and other risks and uncertainties associated with the pandemic have impacted our operations and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In addition, we are subject to other challenges and risks specific to our business and our ability to execute on our business plan and strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with research and development operations, including, without limitation, risks and uncertainties associated with: delays or problems in obtaining clinical supply; obtaining regulatory approval of product candidates; loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing intellectual property rights; and the challenges of complying with applicable regulatory requirements. In addition, as the ongoing COVID-19 pandemic affects our business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. Use of Estimates These financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. Our critical accounting policies are those that are both most important to our financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. We anticipate that the COVID-19 pandemic will continue to disrupt our supply chain and marketing and sales efforts for certain of our products, including Bendeka, although it is not currently expected that any disruption would be significant. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates, and any such differences may be material to our financial statements. Reclassifications Certain reclassifications have been made to prior year amounts to conform with the current year presentation, including for amounts related to accounts receivable, net and prepaid expenses and other current assets. None of the amounts pertaining to the reclassifications were significant. Cash and Cash Equivalents We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. We, at times, maintain balances with financial institutions in excess of the Federal Deposit Insurance Corporation (“FDIC”) limit. Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. Financial assets and liabilities measured and recognized at fair value are as follows: June 30, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 104,614 $ 104,614 $ — $ — Convertible Promissory Note 3,776 — — 3,776 Embedded Derivative Asset in Convertible Promissory Note 464 — — 464 Investment in Tyme 12,600 12,600 — — Total financial assets $ 121,454 $ 117,214 $ — $ 4,240 December 31, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 79,682 $ 79,682 $ — $ — Investment in Tyme 12,200 12,200 — — Total financial assets $ 91,882 $ 91,882 $ — $ — We recognize transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three months or six months ended June 30, 2021 and 2020, respectively. Our investment in the convertible promissory note and the embedded derivative are classified as Level 3. We analyzed and accessed the embedded derivative feature contained in the convertible promissory note agreement. We used a probability factor to value the embedded derivative asset based on management's best estimate, including the principal and estimated accrued interest among other contractual terms. The convertible promissory note is accounted for as available for sale. The convertible promissory note is reported at fair value with unrealized gains and losses included in Accumulated other comprehensive income (loss). Refer to Note 13, Convertible Promissory Note for further details. Our investment in restricted shares of common stock of Tyme Technologies, Inc.are classified as Level 1. Refer to Note 12, Collaboration with Tyme for further details. The fair value of debt is classified as Level 2 for the periods presented and approximates its fair value due to the variable interest rate. Intangible Assets We review the recoverability of our finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, we measure the amount of the impairment by comparing to the carrying value of the assets to the fair value of the assets. The Company determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed as of June 30, 2021. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics acquisition. Goodwill is not amortized, but is evaluated for impairment on an annual basis, in the fourth quarter, or more frequently if events or changes in circumstances indicate that the reporting unit’s goodwill is less than its carrying amount. We did not identify any impairment to goodwill during the periods presented. Concentration of Major Customers and Vendors We are dependent on our commercial partner, Teva, who markets and sells Bendeka. Our customer for Bendeka is our commercial and licensing partner; therefore, our future revenues are highly dependent on the related exclusive license and distribution arrangement. In March 2019, we entered into an agreement with Teva, or the Bendeka License Agreement, pursuant to which Teva has agreed to market Bendeka through its subsidiary, Cephalon, Inc. Pursuant to the Bendeka License Agreement, Teva pays us a royalty based on net sales of the product and also purchases Bendeka from us. The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Three Months Ended Six Months Ended 2021 2020 2021 2020 Total revenues Teva - See Revenue Recognition 64 % 78 % 65 % 71 % Other 36 % 22 % 35 % 29 % 100 % 100 % 100 % 100 % June 30, December 31, 2021 2020 Accounts receivable Teva - See Revenue Recognition 59 % 58 % Other 41 % 42 % 100 % 100 % Inventories Inventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. We periodically review the composition of inventory in order to identify obsolete, slow-moving or otherwise non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventory, we will record a write-down to lower of cost and net realizable value in the period that the decline in value is first recognized. Research and Development Expense Costs for research and development are charged to expense as incurred and include; employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities, costs associated with regulatory operations; and depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the condensed consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $0.4 million and $0.8 million for the three months ended June 30, 2021 and 2020, respectively, and $0.7 million and $1.9 million for the six months ended June 30, 2021 and 2020, respectively. Income Taxes We account for income taxes using the liability method in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), 740 - Income Taxes (“ASC 740”). Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income (loss) in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. ASC 740 also prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that a company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606 - Revenue from Contracts with Customers (“ASC 606”), we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determines those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue. Receivables from our product sales have payment terms ranging from 30 to 75 days with select extended terms to wholesalers on initial purchases of product launch quantities. Our receivables from royalty revenue are due 45 days from the end of the quarter. Product revenue - We recognize net revenue on sales to our commercial partners and to end users. In each instance, revenue is generally recognized when the customer obtains control of our product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract. Revenue on sales to commercial partners relates to Bendeka and Treakisym. Sales to our commercial partners are presented gross because we are primarily responsible for fulfilling the promise to provide the product, and are responsible to ensure that the product is produced in accordance with the related supply agreement and we bear risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price utilizing the expected value method to which we expect to be entitled. As such, revenue on sales to customers for Belrapzo and Ryanodex are recorded net of chargebacks, rebates, returns, prompt pay discounts, wholesaler fees and other deductions. Our products are contracted with a limited number of oncology distributors and hospital buying groups with narrow differences in ultimate realized contract prices used to estimate our chargeback and rebate reserves. We have a product return policy on some of our products that allows the customer to return pharmaceutical products within a specified period of time both prior to and subsequent to the product’s expiration date. Our estimate of the provision for returns is analyzed quarterly and is based upon many factors, including historical experience of actual returns and analysis of the level of inventory in the distribution channel, if any. We have terms on sales of Ryanodex by which we do not accept returns. Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our anticipated performance and all information (historical, current and forecasted) that is reasonably available. We believe that the estimates we have established are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. Components of Gross-to-Net (GTN) Estimates Chargebacks : Chargebacks are discounts that occur when certain contracted customers, including group purchasing organizations (“GPOs”), public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase from our distributors. Our distributors purchase product from us at invoice price, then resell the product to certain contracted customers on the basis of prices negotiated between us and the providers. The difference between the distributors’ purchase price and the typically lower certain contracted customers’ purchase price is refunded to the distributors through a chargeback credit. We record estimates for these chargebacks at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances. The provision for chargebacks is the most significant provision in the context of our gross-to-net adjustments in the determination of net revenue. Chargebacks are estimated based on payer mix and contracted price, adjusted for current period assumptions. Commercial and Medicaid Rebates : We contract with government agencies or collectively, third-party payors, so that Belrapzo and Ryanodex will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. We estimate the rebates we will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued expenses and other current liabilities on the consolidated balance sheets. We estimate the rebates that we will provide to third-party payors based upon (i) our contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payer mix, and (iv) information obtained from our distributors. The information that we also consider when establishing our rebate reserves are purchases by customers, projected annual sales for customers, actual rebates payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them. We regularly review and monitor estimated or actual customer inventory information at our largest distributors for our key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : Our distributors have the right to return unopened unprescribed Belrapzo during certain time periods around the period beginning prior to the labeled expiration date and ending after the labeled expiration date. We estimate future product returns on sales of Belrapzo based on: (i) data provided to us by our distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided us with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to us from retail pharmacies, (iii) data provided to us by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of Belrapzo previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by our distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. Our provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. Additionally, we consider other factors when estimating our current period return provision, including levels of inventory in the distribution channel, significant market changes that may impact future expected returns, and actual product returns, and may record additional provisions for specific returns that it believes are not covered by the historical rates. Our commercial returns policy and terms with certain customers also states that certain products are sold as non-returnable. Wholesaler fees and other incentives : We generally provide invoice discounts on Belrapzo and Ryanodex sales to our distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to us. The payment terms for sales to distributors generally include a 2% discount for prompt payment which is generally defined in invoice terms as a range from 15 to 45 days, while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, we expect our distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from our gross product revenues and accounts receivable at the time such revenues are recognized. Other GTN considerations We may at our discretion provide price adjustments due to various competitive factors. There are circumstances under which we may not provide price adjustments to certain customers as a matter of business strategy, and consequently may lose future sales volume to competitors and risk a greater level of product returns. As detailed above, we have the experience and access to relevant information that we believe are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions we use for certain of these estimates are based on information received from third parties, such as wholesale customer inventories and market data, or other market factors beyond our control. The estimates that are most critical to the establishment of these reserves, and therefore, would have the largest impact if these estimates were not accurate, are estimates related to contract sales volumes, average contract pricing, customer inventories and return volumes. We regularly review the information related to these estimates and adjust our reserves accordingly, if and when actual experience differs from previous estimates. With the exception of the product returns allowance, the ending balances of accounts receivable reserves and allowances generally are processed during a two-month to four-month period. Royalty Revenue — We recognize revenue from license arrangements with our commercial partners' net sales of products. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the commercial partner’s products occurs. Our commercial partners are obligated to report their net product sales and the resulting royalty due to us within 25 days for Bendeka. Based on historical product sales, royalty receipts and other relevant information, we accrue royalty revenue each quarter and subsequently determine a true-up when we receive royalty reports from our commercial partners. Historically, these true-up adjustments have been immaterial. License and other revenue — We analyze each element of our licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. We determine standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. We recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, we determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, we assess each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, we will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of June 30, 2021. Stock-Based Compensation We account for stock-based compensation using the fair value provisions of ASC 718, Compensation - Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors and record expense over the employees' service periods, which are generally the vesting period of the equity awards. We account for stock-based compensation by measuring and recognizing compensation expense for all stock-based payments made to employees and directors based on estimated grant date fair values. The straight-line method is used to allocate compensation cost to reporting periods over each optionee's requisite service period, which is generally the vesting period. The fair value of our stock option awards to employees and directors is estimated using the Black-Scholes valuation model and a Monte Carlo simulation model is used to estimate the fair value for market condition share units. These models require the input of subjective assumptions, including the expected stock price volatility, the calculation of expected term, historical forfeitures and the fair value of the underlying common stock on the date of grant, among other inputs. The risk-free interest rate is determined with the implied yield currently available for zero-coupon U.S. government issues with a remaining term approximating the expected life of the options. The fair value of RSUs granted are estimated based on the trading price of our common stock on the date of grant. The fair value of performance condition PSUs granted are also estimated based on the trading price of our common stock on the date of grant and adjusted for the probability of achievement of the performance conditions. Forfeitures are estimated for all stock-based awards. Earnings Per Share Basic earnings per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemp |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment consisted of the following: June 30, 2021 December 31, 2020 Estimated Useful Life (years) Furniture and fixtures $ 1,476 $ 1,476 7 Office equipment 1,077 1,152 3 Equipment 3,829 3,485 7 Leasehold improvements 1,155 1,155 2 7,537 7,268 Less accumulated depreciation (5,570) (5,191) Property and equipment, net $ 1,967 $ 2,077 Depreciation expense related to property and equipment amounted to $188 and $209 for the three months ended June 30, 2021 and 2020, respectively, and $378 and $460 for the six months ended June 30, 2021 and 2020, respectively. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: June 30, December 31, 2021 2020 Raw materials $ 1,977 $ 3,515 Work in process 4,578 2,589 Finished products 1,739 1,971 Total Inventories $ 8,294 $ 8,075 |
Balance Sheet Accounts
Balance Sheet Accounts | 6 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: June 30, December 31, 2021 2020 Prepaid FDA user fee and advances to clinical research organization $ 421 $ 1,262 Prepaid insurance 743 191 Advances to commercial manufacturers 212 660 All other 4,458 2,044 Total Prepaid expenses and other current assets $ 5,834 $ 4,157 Accrued Expenses Accrued expenses consist of the following: June 30, December 31, 2021 2020 Accrued sales reserves $ 4,339 $ 4,966 Royalties payable to commercial partners 5,910 5,996 Accrued salary and other compensation 3,909 4,686 Accrued professional fees 2,307 2,370 Accrued research & development 3,968 2,724 Current portion of lease liability 1,174 1,123 Accrued other 3,921 1,952 Total Accrued expenses $ 25,528 $ 23,817 Leases We lease office space in Woodcliff Lake, New Jersey for our principal office under an amended lease agreement through June 2025. We also lease a lab space in Cambridge, Massachusetts under a lease agreement through April 2024. Both of our leases are classified as operating leases and have remaining lease terms of approximately 3.6 years. The principal office and the lab space leases include renewal options to extend the lease for up to 5 years. Furthermore, we have not elected the practical expedient to separate lease and non-lease components for all classes of underlying assets. The table below summarizes our total lease costs included in the condensed consolidated financial statements, as well as other required quantitative disclosures (in thousands): June 30, 2021 December 31, 2020 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 346 $ 1,323 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 855 Weighted-average remaining lease term - operating leases 3.6 years 4.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % Balance Sheet Classification at June 30: Current lease liabilities $ 1,174 Long-term lease liabilities 3,360 Total lease liabilities $ 4,534 |
Intangible Assets, Net
Intangible Assets, Net | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Intangible Assets, Net The gross carrying amounts and net book value of our intangible assets are as follows: June 30, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Ryanodex intangible (i) 20 $ 15,000 $ (4,103) $ 10,897 Developed technology 5 8,100 (7,492) 608 Total $ 23,100 $ (11,595) $ 11,505 December 31, 2020 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Ryanodex intangible (i) 20 15,000 (3,500) 11,500 Developed technology 5 8,100 (6,683) 1,417 Total $ 23,100 $ (10,183) $ 12,917 (i) Represents a one-time payment made to reduce the royalties payable to a third party on Ryanodex net sales. Amortization expense was $706 and $667 for the three months ended June 30, 2021 and 2020, respectively and $1,412 and $1,333 for the six months ended June 30, 2021 and 2020, respectively. Estimated Amortization Expense for Intangible Assets Based on definite-lived intangible assets recorded as of June 30, 2021, and assuming that the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2021 (remainder) 1,210 2022 1,369 2023 1,570 2024 1,898 2025 1,520 Thereafter 3,938 Total estimated amortization expense $ 11,505 |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Common Stock and Stock-Based Compensation | Common Stock and Stock-Based Compensation Common Stock Share Repurchase Program On March 17, 2020, we announced that our Board approved a new share repurchase program, or the Share Repurchase Program, providing for the repurchase of up to an aggregate of $160 million of our outstanding common stock. The Share Repurchase Program replaced our then existing share repurchase program, or the Previous Share Repurchase Program, which was announced on October 30, 2018 and was terminated in connection with the Board’s approval of the Share Repurchase Program. At termination, we had repurchased approximately $68 million of our outstanding common stock under the Previous Share Repurchase Program. Under the Share Repurchase Program, we are authorized to repurchase shares through open market purchases, privately-negotiated transactions, accelerated share repurchases or otherwise in accordance with applicable federal securities laws, including through Rule 10b5-1 trading plans and under Rule 10b-18 of the Exchange Act. The repurchases have no time limit and may be suspended or discontinued completely at any time. The specific timing and amount of repurchases will vary based on available capital resources and other financial and operational performance, market conditions, securities law limitations, and other factors. The repurchases will be made using our cash resources. On September 23, 2020, our Board of Directors approved a $25 million accelerated share repurchase (“ASR”) transaction with JPMorgan Chase Bank, National Association (“JP Morgan”) as part of our existing $160 million share repurchase program. The specific number of shares to be repurchased pursuant to the ASR is based on the average of the daily volume weighted average share prices of our common stock, less a discount, during the term of the ASR program. Under the terms of our agreement with JP Morgan, we paid $25 million to JP Morgan on September 24, 2020, and received 550,623 shares, representing the notional amount of the ASR, based on the average of the daily volume weighted average share prices of our common stock, less a discount, during the term of the ASR, which was $45.40. The ASR was completed in the fourth quarter of 2020. We determined the ASR contained a forward contract and therefore we recorded fair value adjustments on the accelerated share repurchase agreement in the amount of $3 million which was a loss recorded in Other expense on our consolidated statements of operations in the year ended December 31, 2020. As of June 30, 2021, we had repurchased an aggregate of 3,782,861 shares of common stock for an aggregate of $211.2 million pursuant to our share repurchase programs in effect since August 2016. Stock-Based Compensation In November 2013, our Board of Directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2014 Plan provides for the awards of incentive stock options, non-qualified stock options, restricted stock, restricted stock units and other stock-based awards. Awards generally vest equally over a period of four years from grant date. Vesting may be accelerated under a change in control of the Company or in the event of death or disability to the recipient. In the event of termination, any unvested shares or options are forfeited. During the first quarter of 2018, we introduced a new long-term incentive program with the objective to better align the stock-based awards granted to management with our focus on improving total shareholder return over the long-term. The stock-based awards granted under this long-term incentive program consist of time-based stock options, time-based restricted stock units ("RSUs") and performance-based stock units ("PSUs"). PSUs are comprised of awards: i) that would have vested upon achievement of certain share price appreciation conditions or ii) that would have vested upon achievement of certain milestone events. These PSUs expired in the first quarter of 2021. During the first quarter of 2021, 97,750 market condition PSUs expired. We also granted 99,500 market condition PSUs based on our total shareholder return ("TSR") relative to the TSR of each member of the S&P Biotechnology Select Industry Index (the defined peer group) with a weighted-average grant date fair value of $71.09 per respective PSU. The fair value of PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation include a risk-free interest rate of 0.18%, an expected volatility of 44%, contractual term of 3 years, and no expected dividend yield. During the first quarter of 2021, we also granted 59,500 performance based (milestones) PSUs with grant date fair value of $49.32 using our closing stock price on the date of the grant. These PSUs will vest (if earned) from 0% to 200% of target number granted based on the achievement of one or more of three milestones related to i) regulatory approval of Fulvestrant ("EA-114"), ii) sales of PEMFEXY and; iii) sales of Vasopressin, respectively. The contractual term of these awards is 3 years. We estimated 0% probability of achievement for the year-to-date period of 2021. A summary of stock option, RSU and PSU activity under the 2014 Plan during the six months ended June 30, 2021 and 2020 is presented below: Stock Options RSUs PSUs Outstanding at December 31, 2019 3,096,161 251,215 116,181 Granted 600,700 231,450 — Options Exercised/RSUs Vested/PSUs Vested (38,951) (67,970) — Forfeited or expired (78,478) (11,074) (2,431) Outstanding at June 30, 2020 3,579,432 403,621 113,750 Outstanding at December 31, 2020 3,331,890 328,396 97,750 Granted 106,000 106,600 159,000 Options Exercised/RSUs Vested/PSUs Vested (94,328) (94,273) — Forfeited or expired (283,998) (29,796) (97,750) Outstanding at June 30, 2021 3,059,564 310,927 159,000 Stock Options The fair value of stock options granted to employees, directors, and consultants were estimated using the following assumptions: Three Months Ended Six Months Ended 2021 2020 2021 2020 Risk-free interest rate 1.01% - 1.12% 0.44% - 0.44% 0.51% - 1.12% 0.44% - 1.65% Volatility 55.66% 55.46% 56.10% 54.94% Expected term (in years) 5.96 years 6.08 years 5.67 years 6.03 years Expected dividend yield 0.0% 0.0% 0.0% 0.00% RSUs Each vested time-based RSU represents the right of a holder to receive one share of our common stock. The fair value of each RSU granted was estimated based on the trading price of our common stock on the date of grant. PSUs The fair value of market condition PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation are described above. The fair value of performance condition PSUs granted to employees was estimated based on the trading price of our common stock on the date of grant adjusted for probability of achievement of the performance conditions as described above. We did not recognize any expense for performance based PSUs granted to employees based on our estimated probability of achievement as described above. We recognized stock-based compensation in our condensed consolidated statements of operations for the three and six months ended June 30, 2021 and 2020 as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Stock options $ 2,547 $ 4,153 $ 5,878 $ 9,146 RSUs 1,217 1,334 3,005 3,186 PSUs 517 754 1,906 1,381 Stock-based compensation expense $ 4,281 $ 6,241 $ 10,789 $ 13,713 Selling, general and administrative $ 3,640 $ 5,207 $ 9,253 $ 11,129 Research and development 641 1,034 1,536 2,584 Stock-based compensation expense $ 4,281 $ 6,241 $ 10,789 $ 13,713 |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Our future material contractual obligations as of June 30, 2021, included the following: Obligations Total 2021 2022 2023 2024 2025 2026 Beyond Operating leases (1) $ 5,031 $ 702 $ 1,423 $ 1,455 $ 1,038 $ 413 $ — $ — Credit facility (2) 30,000 4,000 26,000 — — — — — Purchase obligations (3) 48,213 48,213 — — — — — — Total obligations $ 83,244 $ 52,915 $ 27,423 $ 1,455 $ 1,038 $ 413 $ — $ — (1) We lease our corporate office location. The term of our existing lease expires on June 30, 2025. We also lease our lab space under a lease agreement that expires on October 31, 2023. Rental expense for the operating leases was $325 and $351, for the three months ended June 30, 2021 and 2020, respectively. Rental expense for the operating leases was $650 and $637 for the six months ended June 30, 2021 and 2020. The remaining future lease payments under the operating leases are $5 million as of June 30, 2021. (2) Refer to Note 9, “Debt” for further information regarding our Credit Agreement. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Debt On November 8, 2019, we entered into the Second Amended and Restated Credit Agreement (the “Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative agent (the “Agent”) and the lenders party thereto. The terms and amounts borrowed under the Credit Agreement includes a drawn term loan of $40 million and an undrawn revolving credit facility of $110 million. The schedule of principal payments for the new term loan facility was extended to November 8, 2022. We classified the current portion of long-term debt of $8 million on the condensed consolidated balance sheet as of June 30, 2021. Per the terms of the Credit Agreement, the Company is limited in its ability to pay dividends. As of June 30 2021, we were in compliance with each of the senior secured net leverage ratio; total net leverage ratio; and fixed charge coverage ratio covenants. The term loan facility bears interest at the Adjusted LIBOR (equal to (a) the LIBOR for such Interest Period multiplied by (b) the Statutory Reserve Rate as established by Board of Governors of the Federal Reserve System of the United States of America) for the interest period in effect for such borrowing plus the applicable rate as described below. The Agent and us may amend the Credit Agreement to replace the LIBOR with a Benchmark Replacement, described below. Loans under the Credit Agreement bear interest at a rate equal to either (a) the LIBOR rate, plus an applicable margin ranging from 2.25% to 3.0% per annum, based upon the total net leverage ratio (as defined in the Credit Agreement), or (b) the Benchmark Replacement which is defined as the greatest of the prime lending rate, or the NYFRB Rate (the rate for a federal funds transaction) in effect on such day plus ½ of 1% or the Adjusted LIBO Rate for a one month Interest Period on such day plus 1% plus an applicable margin ranging from 1.25% to 2.0% per annum, based upon the total net leverage ratio. We are required to pay a commitment fee on the unused portion of the new revolving credit facility in the Credit Agreement at a rate ranging from 0.35% to 0.45% per annum based upon the total net leverage ratio. As of June 30, 2021, we had $0.6 million of unamortized deferred debt issuance costs as part of long-term debt in its condensed consolidated balance sheets. Debt Maturities As of June 30, 2021 2021 (remainder) $ 4,000 2022 26,000 Total $ 30,000 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Income tax provision $ (1,936) $ (5,629) $ (3,697) $ (5,492) Effective tax rate 35 % 105 % 54 % 232 % For interim periods, we recognize an income tax provision based on our estimated annual effective tax rate expected for the entire year plus the effects of certain discrete items occurring in the quarter. The interim annual estimated effective tax rate is based on the statutory tax rates then in effect, as adjusted for changes in estimated permanent differences, and certain discrete items whose tax effect, when material, is recognized in the interim period in which they occur. The provision for income taxes was based on the applicable federal and state tax rates for those periods. The effective tax rate for the three and six months ended June 30, 2021 reflects the impact of certain non-deductible executive compensation and expired stock compensation, partially offset by credits for research and development activity and excess tax deduction the Company can realize for its stock based awards. We review the realizability of our deferred tax assets on a quarterly basis, or whenever events or changes in circumstances indicate that a review is required. In determining the requirement for a valuation allowance, the historical and projected financial results of the legal entity or consolidated group recording the net deferred tax asset are considered, along with any other positive or negative evidence. Since future financial results, including the fair value adjustment on our investment in Tyme may differ from previous estimates, periodic adjustments to our valuation allowances may be necessary. Deferred income tax assets as of June 30, 2021 consisted of temporary differences primarily related to stock-based compensation and research and development tax credit carryforwards, partially offset by temporary differences related to intangible assets. We file income tax returns in the U.S. federal jurisdiction and several states. Given that we have incurred tax losses in most years since our inception, all of our tax years are effectively open to examination. We are currently under audit by three State tax jurisdictions. We had no amount recorded for any unrecognized tax benefits as of June 30, 2021. We regularly evaluate our tax positions for additional unrecognized tax benefits and associated interest and penalties, if applicable. There are many factors that are considered when evaluating these tax positions including: interpretation of tax laws, recent tax litigation on a position, past audit or examination history, and subjective estimates and assumptions. We reflect interest and penalties attributable to income taxes, to the extent they arise, as a component of income tax provision or benefit. |
Legal Proceedings
Legal Proceedings | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal Proceedings In addition to the below legal proceedings, from time to time, we may be a party to litigation and subject to claims incident to the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters, or matters discussed below, will not have a material adverse effect on our business nor have we recorded any loss in connection with these matters because we believe that loss is neither probable nor estimable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Commercial Litigation Cipla v. Eagle On April 16, 2020, Cipla Limited (“Cipla”) filed a request for arbitration against Eagle with the London Court of International Arbitration. The request alleges that Eagle’s refusal to take delivery of several batches of Argatroban finished drug product constitutes a breach of the parties’ December 14, 2012 supply agreement. Eagle believes that the allegations against it are without merit and is vigorously defending itself in the Arbitration, which was scheduled for June 2021, has been rescheduled for November 2021. Patent Litigation Eagle Pharmaceuticals, Inc. and ScinoPharm Taiwan, Ltd. v. Shilpa Medicare Ltd. (Pemfexy) On December 23, 2020, we, along with ScinoPharm Taiwan Ltd. (together, “Eagle”) brought suit against Shilpa Medicare Limited in the United States District Court for the District of New Jersey. Eagle alleges infringement based on the filing of Shilpa’s NDA seeking approval to manufacture and sell Pemetrexed injection prior to the expiration of U.S. Patent No. 9,604,990. Shilpa had accepted service. On February 11, 2021, Shilpa amended its NDA to withdraw its exclusivity statement referencing Pemfexy TM and its patent certification to the ‘990 patent. A joint stipulation of dismissal was filed March 26, 2021, and dismissal was ordered April 19, 2021. Eagle Pharmaceuticals, Inc., et al. v. Slayback Pharma Limited Liability Company; Eagle Pharmaceuticals, Inc., et al. v. Apotex Inc. and Apotex Corp.; Eagle Pharmaceuticals, Inc., et al. v. Fresenius Kabi USA, LLC; Eagle Pharmaceuticals, Inc., et al. v. Mylan Laboratories Limited; Eagle Pharmaceuticals, Inc. et al. v. Hospira, Inc; Eagle Pharmaceuticals, Inc. et al. v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc.; Teva Pharmaceuticals Int’l GmbH et al v. Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., and Eugia Pharma Specialities Ltd.; Teva Pharmaceuticals Int’l GmbH et al v. Accord Healthcare Inc., Accord Healthcare Ltd., and Intas Pharmaceuticals Ltd.; Teva Pharmaceuticals Int’l GmbH et al v. Dr. Reddy’s Laboratories, Ltd., and Dr. Reddy’s Laboratories, Inc. - (Bendeka ® ) Bendeka, which contains bendamustine hydrochloride, is an alkylating drug that is indicated for the treatment of patients with chronic lymphocytic leukemia, as well as for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Slayback Pharma Limited Liability Company (“Slayback”), Apotex Inc. and Apotex Corp. (“Apotex”), Fresenius Kabi USA, LLC (“Fresenius”), Mylan Laboratories Limited (“Mylan”), Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”), and Aurobindo Pharma, Ltd, Aurobindo Pharma USA, Inc., and Eugia Pharma Specialities Ltd (“Aurobindo”) have filed Abbreviated New Drug Applications (“ANDA’s”) referencing Bendeka ® that include challenges to one or more of the Bendeka ® Orange Book-listed patents. Hospira, Inc. (“Hospira”) filed a 505(b)(2) NDA. We, Cephalon, Inc. and/or Teva Pharmaceuticals International GMBH (together the “Patentees”), filed separate suits against Slayback, Apotex, Fresenius, Mylan, Hospira, Lupin, and Aurobindo in the United States District Court for the District of Delaware on August 16, 2017 (Slayback (“Slayback I”)), August 18, 2017 (Apotex), August 24, 2017 (Fresenius), December 12, 2017 (Mylan), January 19, 2018 (Slayback (“Slayback II”)), July 19, 2018 (Hospira), and July 2, 2019 (Lupin) and May 11, 2020 (Aurobindo). In these Complaints, the Patentees allege infringement of the challenged patents, namely U.S. Patent Nos. 8,791,270 and 9,572,887 against Slayback (Slayback I and Slayback II), and of U.S. Patent Nos. 8,609,707, 8,791,270, 9,000,021, 9,034,908, 9,144,568, 9,265,831, 9,572,796, 9,572,797, 9,572,887, 9,579,384, 9,597,397, 9,597,398, 9,597,399 against Fresenius, Apotex, and Mylan, and of U.S. Patent Nos. 9,572,887, 10,010,533, 9,034,908, 9,144,568, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384 against Hospira, and of U.S. Patent Nos. 8,609,707, 9,000,021, 9,034,908, 9,144,568, 9,265,831, 9,572,796, 9,572,797, 9,572,887, 9,579,384, 9,597,397, 9,597,398, 9,597,399, 10,010,533, and 10,052,385 against Lupin and of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385 against Aurobindo. The parties stipulated to dismiss without prejudice U.S. Patent No. 8,791,270 as to Apotex, Fresenius and Mylan on July 24, 2018, August 2, 2018, and August 3, 2018, respectively. Slayback, Apotex, Fresenius, and Mylan answered their Complaints and some filed various counterclaims on September 29, 2017 (Slayback I), February 12, 2018 (Slayback II), November 27, 2017, September 15, 2017, and February 14, 2018, respectively. The Patentees answered the Slayback I, Slayback II, Fresenius, and Apotex counterclaims on October 20, 2017, March 5, 2018, October 6, 2017, and December 18, 2017, respectively. On October 15, 2018, the Patentees filed a suit against Fresenius and Mylan in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 10,010,533 and 10,052,385. The Slayback I, Slayback II, Apotex, Fresenius and Mylan cases have been consolidated for all purposes (the “Consolidated Bendeka Litigation”), and a bench trial in these cases was held September 9-19, 2019. On April 27, 2020, the district court held that the asserted patents are valid and infringed by Slayback, Apotex, Fresenius and Mylan. On July 6, 2020, the district court entered a final judgment reflecting this decision, stating that pursuant to 35 U.S.C. § 271(e)(4)(A), the FDA shall not approve Apotex’s, Fresenius’s, Mylan’s, or Slayback’s ANDA products on a date which is earlier than January 28, 2031, and enjoining Apotex, Fresenius, Mylan, and Slayback from commercially manufacturing, using, offering to sell, or selling within the US or importing into the US, their ANDA products before that date. On August 4, 2020, Apotex, Fresenius, and Mylan appealed this final judgment, and filed their opening briefs on November 4, 2020. Plaintiffs’ responsive appeal brief was filed on February 12, 2021. Defendants’ reply briefs were filed April 5, 2021. On August 2, 2021, Fresenius’s appeal was dismissed pursuant to a settlement agreement reached with Patentees. Oral argument for the remaining defendants occurred on August 3, 2021. Hospira filed a motion to dismiss, which was fully briefed on November 16, 2018. On December 16, 2019, the United States District Court for the District of Delaware denied Hospira’s motion to dismiss with respect to U.S. Patent No. 9,572,887 and granted that motion with respect to the remaining patents. On December 15, 2020, the Court held a claim construction hearing, ruling in our favor on all claim terms. Fact discovery closed on April 1, 2021. Expert discovery is expected to close August 23, 2021. Trial is scheduled for November 15, 2021. The case remains pending. On March 10, 2020, the parties filed a stipulation and order of dismissal without prejudice as to Lupin, which the Court entered March 11, 2020. Aurobindo answered the Complaint on July 20, 2020. The parties exchanged initial disclosures on December 11, 2020. Plaintiffs provided their infringement contentions on March 12, 2021. Trial is scheduled for July 18, 2022. The case is currently stayed, pending the outcome of the appeal in the consolidated cases against Mylan and Apotex. The FDA is stayed from approving Aurobindo’s ANDA, and Hospira’s 505(b)(2) application, until the earlier of (1) October 6, 2022 and December 7, 2020 respectively (the “30-month stay dates”); and (2) a court decision that each of the challenged patents is not infringed, invalid, or unenforceable. The 30-month stay dates may be shortened or lengthened if either party to the action fails to reasonably cooperate in expediting the action. Patentees filed suit against Dr. Reddy’s Laboratories on May 13, 2021. Patentees have asserted U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385. Dr. Reddy’s answer is due August 16, 2021. Patentees filed suit against Accord Healthcare on June 29, 2021. Patentees have asserted U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385. Accord’s answer is due September 28, 2021. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company Slayback filed an ANDA referencing Eagle's Belrapzo NDA. Slayback’s ANDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On September 20, 2018, the Company filed a suit against Slayback in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797 and 10,010,533. On October 10, 2018, Slayback answered the Complaint and filed various counterclaims. On October 31, 2018, the Company answered Slayback’s counterclaims. Pursuant to a stipulation between the parties, Slayback is bound by any final judgment entered in the Consolidated Bendeka Litigation. This case is currently stayed. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc. (Vasopressin) On May 31, 2018, Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (together, “Par”) filed suit against the Company in the United States District Court for the District of Delaware. Par alleged patent infringement based on the filing of the Company’s ANDA seeking approval to manufacture and sell the Company’s vasopressin product. The Company’s vasopressin product, if approved by FDA, will be an alternative to Vasostrict, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. The Company answered the complaint on August 6, 2018, and filed an amended answer and counterclaims on October 30, 2019. The court issued a Markman ruling on July 1, 2019. On December 20, 2019, Par dismissed with prejudice claims of three of the patents asserted against Eagle, and the Court entered an Order reflecting that dismissal on December 27, 2019. Mediation took place on March 3, 2020. On April 17, 2020, we submitted a letter requesting leave to file a motion for summary judgment of non-infringement. Par’s responsive letter was submitted on May 8, 2020. On May 18, 2020, the court said it would hear non-infringement arguments at trial and not through summary judgment. Fact discovery ended in October 2019, and expert discovery ended in February 2020. Due to the COVID-19 pandemic, the trial, which was scheduled to begin May 18, 2020, was rescheduled to and occurred on July 7-9, 2021. Post-trial briefing was submitted on July 28, 2021. The 30-month stay of FDA approval expired on October 17, 2020. This suit is pending. On December 7, 2020, Par filed a separate suit against us in the United States District Court for the District of New Jersey, asserting patent infringement of U.S. Patent No. 10,844,435, based on the filing of our ANDA seeking approval to manufacture and sell our vasopressin product. Eagle moved to dismiss Par’s complaint on March 2, 2021. On March 22, 2021, Par amended its complaint to additionally assert U.S. Patent No. 10,920,278, and on April 5, 2021, Eagle moved to dismiss Par’s amended complaint. This suit is pending. Eagle Pharmaceuticals, Inc. et al. v. Accord (Argatroban) |
Collaboration with Tyme
Collaboration with Tyme | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration with Tyme | Collaboration with Tyme As of June 30, 2021, we included our investment in Tyme in Other Assets (non-current) on our condensed consolidated balance sheet. For the three months ended June 30, 2021 and 2020, the fair value adjustments for the equity investment was a loss of $5.2 million and a gain $2.3 million, respectively. For the six months ended June 30, 2021 and 2020, the fair value adjustments for the equity investment was a gain of $0.4 million and a loss of $4.2 million, respectively. These adjustments were recorded in Other (expense) income on our condensed consolidated statements of operations. |
Convertible Promissory Note
Convertible Promissory Note | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Convertible Promissory Note | Convertible Promissory Note During the first quarter of 2021, we invested $5 million in a convertible promissory note ("the note") of a privately held clinical-stage biotechnology company (the "issuer"). The note bears an 8% annual interest rate and has an 18-month term. The issuer is not required to make any principal or interest payments until the end of the term. The note, along with any accrued interest, may automatically convert into equity securities of the issuer under either a financing event or a change in control event as defined in the convertible promissory note agreement. The issuer's product development efforts could encounter technical or other difficulties that could increase their development costs more than expected. The issuer will likely require additional capital prior to obtaining certain regulatory approval or to be able to repay the convertible promissory note with accrued interest at the end of the term. As of June 30, 2021, we recorded the following: i) $0.9 million fair value adjustment related to the investment in the note which is recorded on statement of comprehensive loss as unrealized loss; ii) a $0.1 million estimated credit loss related to the note; iii) during the three months ended March 31, 2021, an initial $0.3 million fair value adjustment was recorded associated with an embedded derivative contained in the note, with a corresponding discount recorded to the investment in the note; a subsequent adjustment of $0.2 million to increase fair value of the derivative asset was recorded during the three months ended June 30, 2021, for a total $0.5 million derivative asset on our condensed consolidated balance sheet as of June 30, 2021; initial discount on the promissory note of $0.3 million is being accreted over the term of the note and as such, we recorded $0.1 million of interest income during the period ended June 30, 2021; and iv) we recorded $0.1 million of accrued interest income related to the note during the three and six months ended June 30, 2021 in our condensed consolidated statement of operations. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Event On August 6, 2021, we entered into a licensing agreement with AOP Orphan Pharmaceuticals GmbH (“AOP Orphan”), a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to its product, Landiolol in the United States. Landiolol, a leading hospital emergency use product, is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. We will support the submission of a new drug application (“NDA”) by AOP Orphan to the FDA seeking approval for Landiolol for the short term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”) , including atrial fibrillation and atrial flutter. We anticipate the filing of such NDA in the first quarter of 2022, with an expected ten-month review, based on feedback from the FDA provided during AOP Orphan’s Type C meeting with the FDA. Under the terms of the agreement, we will facilitate the U.S. regulatory pathway for the approval of Landiolol. In addition, we will be responsible for the U.S. commercialization of the product upon approval. Landiolol, which has not previously been marketed in the U.S., is covered by several patents, and we anticipate five years of new chemical entity (“NCE”) exclusivity. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates These financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. Our critical accounting policies are those that are both most important to our financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. We anticipate that the COVID-19 pandemic will continue to disrupt our supply chain and marketing and sales efforts for certain of our products, including Bendeka, although it is not currently expected that any disruption would be significant. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates, and any such differences may be material to our financial statements. |
Reclassifications | Reclassifications Certain reclassifications have been made to prior year amounts to conform with the current year presentation, including for amounts related to accounts receivable, net and prepaid expenses and other current assets. None of the amounts pertaining to the reclassifications were significant. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. We, at times, maintain balances with financial institutions in excess of the Federal Deposit Insurance Corporation (“FDIC”) limit. |
Fair Value Measurements | Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. We recognize transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three months or six months ended June 30, 2021 and 2020, respectively. Our investment in the convertible promissory note and the embedded derivative are classified as Level 3. We analyzed and accessed the embedded derivative feature contained in the convertible promissory note agreement. We used a probability factor to value the embedded derivative asset based on management's best estimate, including the principal and estimated accrued interest among other contractual terms. The convertible promissory note is accounted for as available for sale. The convertible promissory note is reported at fair value with unrealized gains and losses included in Accumulated other comprehensive income (loss). Refer to Note 13, Convertible Promissory Note for further details. Our investment in restricted shares of common stock of Tyme Technologies, Inc.are classified as Level 1. Refer to Note 12, Collaboration with Tyme for further details. |
Intangible Assets | Intangible Assets We review the recoverability of our finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, we measure the amount of the impairment by comparing to the carrying value of the assets to the fair value of the assets. The Company determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed as of June 30, 2021. |
Goodwill | GoodwillGoodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics acquisition. Goodwill is not amortized, but is evaluated for impairment on an annual basis, in the fourth quarter, or more frequently if events or changes in circumstances indicate that the reporting unit’s goodwill is less than its carrying amount. |
Concentration of Major Customers and Vendors | Concentration of Major Customers and Vendors We are dependent on our commercial partner, Teva, who markets and sells Bendeka. Our customer for Bendeka is our commercial and licensing partner; therefore, our future revenues are highly dependent on the related exclusive license and distribution arrangement. |
Inventories | Inventories Inventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. We periodically review the composition of inventory in order to identify obsolete, slow-moving or otherwise non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventory, we will record a write-down to lower of cost and net realizable value in the period that the decline in value is first recognized. |
Research and Development Expense | Research and Development Expense Costs for research and development are charged to expense as incurred and include; employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities, costs associated with regulatory operations; and depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the condensed consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. |
Advertising and Marketing | Advertising and MarketingAdvertising and marketing costs are expensed as incurred. |
Income Taxes | Income Taxes We account for income taxes using the liability method in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), 740 - Income Taxes (“ASC 740”). Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the |
Revenue Recognition | Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606 - Revenue from Contracts with Customers (“ASC 606”), we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determines those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue. Receivables from our product sales have payment terms ranging from 30 to 75 days with select extended terms to wholesalers on initial purchases of product launch quantities. Our receivables from royalty revenue are due 45 days from the end of the quarter. Product revenue - We recognize net revenue on sales to our commercial partners and to end users. In each instance, revenue is generally recognized when the customer obtains control of our product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract. Revenue on sales to commercial partners relates to Bendeka and Treakisym. Sales to our commercial partners are presented gross because we are primarily responsible for fulfilling the promise to provide the product, and are responsible to ensure that the product is produced in accordance with the related supply agreement and we bear risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price utilizing the expected value method to which we expect to be entitled. As such, revenue on sales to customers for Belrapzo and Ryanodex are recorded net of chargebacks, rebates, returns, prompt pay discounts, wholesaler fees and other deductions. Our products are contracted with a limited number of oncology distributors and hospital buying groups with narrow differences in ultimate realized contract prices used to estimate our chargeback and rebate reserves. We have a product return policy on some of our products that allows the customer to return pharmaceutical products within a specified period of time both prior to and subsequent to the product’s expiration date. Our estimate of the provision for returns is analyzed quarterly and is based upon many factors, including historical experience of actual returns and analysis of the level of inventory in the distribution channel, if any. We have terms on sales of Ryanodex by which we do not accept returns. Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our anticipated performance and all information (historical, current and forecasted) that is reasonably available. We believe that the estimates we have established are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. Components of Gross-to-Net (GTN) Estimates Chargebacks : Chargebacks are discounts that occur when certain contracted customers, including group purchasing organizations (“GPOs”), public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase from our distributors. Our distributors purchase product from us at invoice price, then resell the product to certain contracted customers on the basis of prices negotiated between us and the providers. The difference between the distributors’ purchase price and the typically lower certain contracted customers’ purchase price is refunded to the distributors through a chargeback credit. We record estimates for these chargebacks at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances. The provision for chargebacks is the most significant provision in the context of our gross-to-net adjustments in the determination of net revenue. Chargebacks are estimated based on payer mix and contracted price, adjusted for current period assumptions. Commercial and Medicaid Rebates : We contract with government agencies or collectively, third-party payors, so that Belrapzo and Ryanodex will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. We estimate the rebates we will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued expenses and other current liabilities on the consolidated balance sheets. We estimate the rebates that we will provide to third-party payors based upon (i) our contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payer mix, and (iv) information obtained from our distributors. The information that we also consider when establishing our rebate reserves are purchases by customers, projected annual sales for customers, actual rebates payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them. We regularly review and monitor estimated or actual customer inventory information at our largest distributors for our key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : Our distributors have the right to return unopened unprescribed Belrapzo during certain time periods around the period beginning prior to the labeled expiration date and ending after the labeled expiration date. We estimate future product returns on sales of Belrapzo based on: (i) data provided to us by our distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided us with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to us from retail pharmacies, (iii) data provided to us by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of Belrapzo previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by our distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. Our provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. Additionally, we consider other factors when estimating our current period return provision, including levels of inventory in the distribution channel, significant market changes that may impact future expected returns, and actual product returns, and may record additional provisions for specific returns that it believes are not covered by the historical rates. Our commercial returns policy and terms with certain customers also states that certain products are sold as non-returnable. Wholesaler fees and other incentives : We generally provide invoice discounts on Belrapzo and Ryanodex sales to our distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to us. The payment terms for sales to distributors generally include a 2% discount for prompt payment which is generally defined in invoice terms as a range from 15 to 45 days, while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, we expect our distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from our gross product revenues and accounts receivable at the time such revenues are recognized. Other GTN considerations We may at our discretion provide price adjustments due to various competitive factors. There are circumstances under which we may not provide price adjustments to certain customers as a matter of business strategy, and consequently may lose future sales volume to competitors and risk a greater level of product returns. As detailed above, we have the experience and access to relevant information that we believe are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions we use for certain of these estimates are based on information received from third parties, such as wholesale customer inventories and market data, or other market factors beyond our control. The estimates that are most critical to the establishment of these reserves, and therefore, would have the largest impact if these estimates were not accurate, are estimates related to contract sales volumes, average contract pricing, customer inventories and return volumes. We regularly review the information related to these estimates and adjust our reserves accordingly, if and when actual experience differs from previous estimates. With the exception of the product returns allowance, the ending balances of accounts receivable reserves and allowances generally are processed during a two-month to four-month period. Royalty Revenue — We recognize revenue from license arrangements with our commercial partners' net sales of products. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the commercial partner’s products occurs. Our commercial partners are obligated to report their net product sales and the resulting royalty due to us within 25 days for Bendeka. Based on historical product sales, royalty receipts and other relevant information, we accrue royalty revenue each quarter and subsequently determine a true-up when we receive royalty reports from our commercial partners. Historically, these true-up adjustments have been immaterial. License and other revenue — We analyze each element of our licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. We determine standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. We recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, we determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, we assess each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, we will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of June 30, 2021. |
Stock-Based Compensation | Stock-Based Compensation We account for stock-based compensation using the fair value provisions of ASC 718, Compensation - Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors and record expense over the employees' service periods, which are generally the vesting period of the equity awards. |
Earnings Per Share | Earnings Per Share Basic earnings per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recent Accounting Pronouncements - Not Yet Adopted In March 2020, the FASB issued Update 2020-04 Reference Rate Reform (Topic 848), Facilitation of the Effects of Reference Rate Reform on Financial Reporting to provide temporary optional guidance to ease the potential burden in accounting for reference rate reform. The amendments in Update 2020-04 are elective and apply to all entities that have contracts, hedging relationships, and other transactions that reference LIBOR, formerly known as the London Interbank Offered Rate, |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of financial assets and liabilities measured and recognized at fair value | Financial assets and liabilities measured and recognized at fair value are as follows: June 30, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 104,614 $ 104,614 $ — $ — Convertible Promissory Note 3,776 — — 3,776 Embedded Derivative Asset in Convertible Promissory Note 464 — — 464 Investment in Tyme 12,600 12,600 — — Total financial assets $ 121,454 $ 117,214 $ — $ 4,240 December 31, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 79,682 $ 79,682 $ — $ — Investment in Tyme 12,200 12,200 — — Total financial assets $ 91,882 $ 91,882 $ — $ — |
Schedule of revenues and accounts receivables by major customers | The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Three Months Ended Six Months Ended 2021 2020 2021 2020 Total revenues Teva - See Revenue Recognition 64 % 78 % 65 % 71 % Other 36 % 22 % 35 % 29 % 100 % 100 % 100 % 100 % June 30, December 31, 2021 2020 Accounts receivable Teva - See Revenue Recognition 59 % 58 % Other 41 % 42 % 100 % 100 % |
Schedule of dilutive and anti-dilutive common shares equivalents outstanding | The anti-dilutive common share equivalents outstanding for the three and six months ended June 30, 2021 and 2020 were as follows: Three Months Ended Six Months Ended 2021 2020 2021 2020 Stock options 2,844,961 2,909,289 1,622,046 2,909,289 Restricted stock units 223,103 229,100 1,413,687 253,677 Total 3,068,064 3,138,389 3,035,733 3,162,966 |
Computation for basic and diluted net (loss) earnings per share | The following table sets forth the computation for basic and diluted net earnings (loss) per share for the three and six months ended June 30, 2021 and 2020: Three Months Ended Six Months Ended 2021 2020 2021 2020 Numerator Numerator for basic and diluted earnings (loss) per share-net earnings (loss) $ 3,612 $ (256) $ 3,191 $ (3,127) Denominator Basic weighted average common shares outstanding 13,108,998 13,664,951 13,116,370 13,666,279 Dilutive effect of stock awards 153,166 — 177,550 — Diluted weighted average common shares outstanding 13,262,164 13,664,951 13,293,920 13,666,279 Basic net earnings (loss) per share Basic net earnings (loss) per share $ 0.28 $ (0.02) $ 0.24 $ (0.23) Diluted net earnings (loss) per share Diluted net earnings (loss) per share $ 0.27 $ (0.02) $ 0.24 $ (0.23) |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment, net | Property and equipment consisted of the following: June 30, 2021 December 31, 2020 Estimated Useful Life (years) Furniture and fixtures $ 1,476 $ 1,476 7 Office equipment 1,077 1,152 3 Equipment 3,829 3,485 7 Leasehold improvements 1,155 1,155 2 7,537 7,268 Less accumulated depreciation (5,570) (5,191) Property and equipment, net $ 1,967 $ 2,077 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of the following: June 30, December 31, 2021 2020 Raw materials $ 1,977 $ 3,515 Work in process 4,578 2,589 Finished products 1,739 1,971 Total Inventories $ 8,294 $ 8,075 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of prepaid and other current assets | Prepaid expenses and other current assets consist of the following: June 30, December 31, 2021 2020 Prepaid FDA user fee and advances to clinical research organization $ 421 $ 1,262 Prepaid insurance 743 191 Advances to commercial manufacturers 212 660 All other 4,458 2,044 Total Prepaid expenses and other current assets $ 5,834 $ 4,157 |
Schedule of accrued expenses | Accrued expenses consist of the following: June 30, December 31, 2021 2020 Accrued sales reserves $ 4,339 $ 4,966 Royalties payable to commercial partners 5,910 5,996 Accrued salary and other compensation 3,909 4,686 Accrued professional fees 2,307 2,370 Accrued research & development 3,968 2,724 Current portion of lease liability 1,174 1,123 Accrued other 3,921 1,952 Total Accrued expenses $ 25,528 $ 23,817 |
Lease related disclosures | The table below summarizes our total lease costs included in the condensed consolidated financial statements, as well as other required quantitative disclosures (in thousands): June 30, 2021 December 31, 2020 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 346 $ 1,323 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 855 Weighted-average remaining lease term - operating leases 3.6 years 4.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % |
Future minimum lease payments | Balance Sheet Classification at June 30: Current lease liabilities $ 1,174 Long-term lease liabilities 3,360 Total lease liabilities $ 4,534 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible asset | The gross carrying amounts and net book value of our intangible assets are as follows: June 30, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Ryanodex intangible (i) 20 $ 15,000 $ (4,103) $ 10,897 Developed technology 5 8,100 (7,492) 608 Total $ 23,100 $ (11,595) $ 11,505 December 31, 2020 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Ryanodex intangible (i) 20 15,000 (3,500) 11,500 Developed technology 5 8,100 (6,683) 1,417 Total $ 23,100 $ (10,183) $ 12,917 (i) Represents a one-time payment made to reduce the royalties payable to a third party on Ryanodex net sales. |
Schedule of future amortization expense of finite-lived intangible assets | Based on definite-lived intangible assets recorded as of June 30, 2021, and assuming that the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2021 (remainder) 1,210 2022 1,369 2023 1,570 2024 1,898 2025 1,520 Thereafter 3,938 Total estimated amortization expense $ 11,505 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of stock options, RSU and PSU activity | A summary of stock option, RSU and PSU activity under the 2014 Plan during the six months ended June 30, 2021 and 2020 is presented below: Stock Options RSUs PSUs Outstanding at December 31, 2019 3,096,161 251,215 116,181 Granted 600,700 231,450 — Options Exercised/RSUs Vested/PSUs Vested (38,951) (67,970) — Forfeited or expired (78,478) (11,074) (2,431) Outstanding at June 30, 2020 3,579,432 403,621 113,750 Outstanding at December 31, 2020 3,331,890 328,396 97,750 Granted 106,000 106,600 159,000 Options Exercised/RSUs Vested/PSUs Vested (94,328) (94,273) — Forfeited or expired (283,998) (29,796) (97,750) Outstanding at June 30, 2021 3,059,564 310,927 159,000 |
Fair value of stock options | The fair value of stock options granted to employees, directors, and consultants were estimated using the following assumptions: Three Months Ended Six Months Ended 2021 2020 2021 2020 Risk-free interest rate 1.01% - 1.12% 0.44% - 0.44% 0.51% - 1.12% 0.44% - 1.65% Volatility 55.66% 55.46% 56.10% 54.94% Expected term (in years) 5.96 years 6.08 years 5.67 years 6.03 years Expected dividend yield 0.0% 0.0% 0.0% 0.00% |
Share-based payment arrangement, cost by plan | We recognized stock-based compensation in our condensed consolidated statements of operations for the three and six months ended June 30, 2021 and 2020 as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Stock options $ 2,547 $ 4,153 $ 5,878 $ 9,146 RSUs 1,217 1,334 3,005 3,186 PSUs 517 754 1,906 1,381 Stock-based compensation expense $ 4,281 $ 6,241 $ 10,789 $ 13,713 Selling, general and administrative $ 3,640 $ 5,207 $ 9,253 $ 11,129 Research and development 641 1,034 1,536 2,584 Stock-based compensation expense $ 4,281 $ 6,241 $ 10,789 $ 13,713 |
Commitments (Tables)
Commitments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of operating lease obligations and purchase obligations | Our future material contractual obligations as of June 30, 2021, included the following: Obligations Total 2021 2022 2023 2024 2025 2026 Beyond Operating leases (1) $ 5,031 $ 702 $ 1,423 $ 1,455 $ 1,038 $ 413 $ — $ — Credit facility (2) 30,000 4,000 26,000 — — — — — Purchase obligations (3) 48,213 48,213 — — — — — — Total obligations $ 83,244 $ 52,915 $ 27,423 $ 1,455 $ 1,038 $ 413 $ — $ — (1) We lease our corporate office location. The term of our existing lease expires on June 30, 2025. We also lease our lab space under a lease agreement that expires on October 31, 2023. Rental expense for the operating leases was $325 and $351, for the three months ended June 30, 2021 and 2020, respectively. Rental expense for the operating leases was $650 and $637 for the six months ended June 30, 2021 and 2020. The remaining future lease payments under the operating leases are $5 million as of June 30, 2021. (2) Refer to Note 9, “Debt” for further information regarding our Credit Agreement. |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of debt maturities | Debt Maturities As of June 30, 2021 2021 (remainder) $ 4,000 2022 26,000 Total $ 30,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Income tax provision $ (1,936) $ (5,629) $ (3,697) $ (5,492) Effective tax rate 35 % 105 % 54 % 232 % |
Basis of Presentation and Oth_2
Basis of Presentation and Other Company Information (Details) | 6 Months Ended |
Jun. 30, 2021product | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of products commercially launched | 3 |
Number of potential future product launches | 5 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Financial Assets and Liabilities Measured and Recognized at Fair Value (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Money market funds | $ 104,614 | $ 79,682 |
Convertible Promissory Note | 3,776 | |
Embedded Derivative Asset in Convertible Promissory Note | 464 | |
Investment in Tyme | 12,600 | 12,200 |
Total financial assets | 121,454 | 91,882 |
Level 1 | ||
Assets: | ||
Money market funds | 104,614 | 79,682 |
Convertible Promissory Note | 0 | |
Embedded Derivative Asset in Convertible Promissory Note | 0 | |
Investment in Tyme | 12,600 | 12,200 |
Total financial assets | 117,214 | 91,882 |
Level 2 | ||
Assets: | ||
Money market funds | 0 | 0 |
Convertible Promissory Note | 0 | |
Embedded Derivative Asset in Convertible Promissory Note | 0 | |
Investment in Tyme | 0 | 0 |
Total financial assets | 0 | 0 |
Level 3 | ||
Assets: | ||
Money market funds | 0 | 0 |
Convertible Promissory Note | 3,776 | |
Embedded Derivative Asset in Convertible Promissory Note | 464 | |
Investment in Tyme | 0 | 0 |
Total financial assets | $ 4,240 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Goodwill impairment loss | $ 0 | $ 0 | $ 0 | $ 0 |
Advertising and marketing costs | $ 400,000 | $ 800,000 | $ 700,000 | $ 1,900,000 |
Bendeka | ||||
Disaggregation of Revenue [Line Items] | ||||
Period after quarter commercial partners report net product sales | 25 days |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Revenue and Accounts Receivable By Major Customer (Details) - Customer Concentration Risk | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Total revenues | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 100.00% | 100.00% | 100.00% | 100.00% | |
Total revenues | Cephalon, Inc. (Teva) | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 64.00% | 78.00% | 65.00% | 71.00% | |
Total revenues | Other | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 36.00% | 22.00% | 35.00% | 29.00% | |
Accounts receivable | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 100.00% | 100.00% | |||
Accounts receivable | Cephalon, Inc. (Teva) | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 59.00% | 58.00% | |||
Accounts receivable | Other | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 41.00% | 42.00% |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Anti-Dilutive Common Shares Equivalents Outstanding (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 3,068,064 | 3,138,389 | 3,035,733 | 3,162,966 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,844,961 | 2,909,289 | 1,622,046 | 2,909,289 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 223,103 | 229,100 | 1,413,687 | 253,677 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net (Loss) Earnings (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Numerator | ||||
Numerator for basic and diluted earnings (loss) per share-net earnings (loss) | $ 3,612 | $ (256) | $ 3,191 | $ (3,127) |
Denominator | ||||
Basic weighted average common shares outstanding (in shares) | 13,108,998 | 13,664,951 | 13,116,370 | 13,666,279 |
Dilutive effect of stock awards (in shares) | 153,166 | 0 | 177,550 | 0 |
Diluted weighted average common shares outstanding (in shares) | 13,262,164 | 13,664,951 | 13,293,920 | 13,666,279 |
Basic net earnings (loss) per share | ||||
Basic net earnings (loss) per share (in dollars per share) | $ 0.28 | $ (0.02) | $ 0.24 | $ (0.23) |
Diluted net earnings (loss) per share | ||||
Diluted net earnings (loss) per share (in dollars per share) | $ 0.27 | $ (0.02) | $ 0.24 | $ (0.23) |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | $ 7,537 | $ 7,537 | $ 7,268 | ||
Less accumulated depreciation | (5,570) | (5,570) | (5,191) | ||
Property and equipment, net | 1,967 | 1,967 | 2,077 | ||
Depreciation expense | 188 | $ 209 | 378 | $ 460 | |
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 1,476 | $ 1,476 | 1,476 | ||
Estimated Useful Life (years) | 7 years | ||||
Office equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 1,077 | $ 1,077 | 1,152 | ||
Estimated Useful Life (years) | 3 years | ||||
Equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 3,829 | $ 3,829 | 3,485 | ||
Estimated Useful Life (years) | 7 years | ||||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | $ 1,155 | $ 1,155 | $ 1,155 | ||
Estimated Useful Life (years) | 2 years |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,977 | $ 3,515 |
Work in process | 4,578 | 2,589 |
Finished products | 1,739 | 1,971 |
Total Inventories | $ 8,294 | $ 8,075 |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid FDA user fee and advances to clinical research organization | $ 421 | $ 1,262 |
Prepaid insurance | 743 | 191 |
Advances to commercial manufacturers | 212 | 660 |
All other | 4,458 | 2,044 |
Total Prepaid expenses and other current assets | $ 5,834 | $ 4,157 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued sales reserves | $ 4,339 | $ 4,966 |
Royalties payable to commercial partners | 5,910 | 5,996 |
Accrued salary and other compensation | 3,909 | 4,686 |
Accrued professional fees | 2,307 | 2,370 |
Accrued research & development | 3,968 | 2,724 |
Current portion of lease liability | 1,174 | 1,123 |
Accrued other | 3,921 | 1,952 |
Total Accrued expenses | $ 25,528 | $ 23,817 |
Balance Sheet Accounts - Narrat
Balance Sheet Accounts - Narrative (Details) | Jun. 30, 2021 |
Balance Sheet Related Disclosures [Abstract] | |
Lessee, operating lease, remaining lease term | 3 years 7 months 6 days |
Lessee, operating lease, renewal term | 5 years |
Balance Sheet Accounts - Lease
Balance Sheet Accounts - Lease Related Disclosures (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities | |||
Operating cash flows for operating leases | $ 346 | $ 1,323 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 0 | $ 842 | $ 855 |
Weighted-average remaining lease term - operating leases | 3 years 7 months 6 days | 4 years 1 month 6 days | |
Weighted-average discount rate - operating leases | 6.00% | 6.00% |
Balance Sheet Accounts - Future
Balance Sheet Accounts - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Classification at June 30: | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | us-gaap:AccruedLiabilitiesCurrent | |
Current lease liabilities | $ 1,174 | $ 1,123 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other long-term liabilities | |
Long-term lease liabilities | $ 3,360 | |
Total lease liabilities | $ 4,534 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | |||||
Gross Carrying Amount | $ 23,100 | $ 23,100 | $ 23,100 | ||
Accumulated Amortization | (11,595) | (11,595) | (10,183) | ||
Net Book Value | 11,505 | 11,505 | $ 12,917 | ||
Amortization expense of intangible assets | 706 | $ 667 | $ 1,412 | $ 1,333 | |
Ryanodex intangible | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Useful Life (In Years) | 20 years | 20 years | |||
Gross Carrying Amount | 15,000 | $ 15,000 | $ 15,000 | ||
Accumulated Amortization | (4,103) | (4,103) | (3,500) | ||
Net Book Value | 10,897 | $ 10,897 | $ 11,500 | ||
Developed technology | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Useful Life (In Years) | 5 years | 5 years | |||
Gross Carrying Amount | 8,100 | $ 8,100 | $ 8,100 | ||
Accumulated Amortization | (7,492) | (7,492) | (6,683) | ||
Net Book Value | $ 608 | $ 608 | $ 1,417 |
Intangible Assets, Net - Sche_2
Intangible Assets, Net - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Estimated Amortization Expense | ||
2021 (remainder) | $ 1,210 | |
2022 | 1,369 | |
2023 | 1,570 | |
2024 | 1,898 | |
2025 | 1,520 | |
Thereafter | 3,938 | |
Net Book Value | $ 11,505 | $ 12,917 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Narrative (Details) | Sep. 24, 2020USD ($)$ / sharesshares | Mar. 31, 2021milestone$ / sharesshares | Jun. 30, 2021USD ($)shares | Jun. 30, 2020USD ($)shares | Dec. 31, 2020USD ($) | Mar. 17, 2020USD ($) | Jun. 30, 2021USD ($)shares | Sep. 23, 2020USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Payments to repurchase stock | $ 4,297,000 | $ 4,999,000 | ||||||
Award vesting period | 4 years | |||||||
Volatility | 56.10% | 54.94% | ||||||
Expected term | 5 years 8 months 1 day | 6 years 10 days | ||||||
Expected dividend yield | 0.00% | 0.00% | ||||||
PSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Expired (in shares) | shares | 97,750 | 97,750 | 2,431 | |||||
Granted (in shares) | shares | 159,000 | 0 | ||||||
Risk-free interest rate | 0.18% | |||||||
Volatility | 44.00% | |||||||
Expected term | 3 years | |||||||
Expected dividend yield | 0.00% | |||||||
PSUs | S&P Biotechnology | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Granted (in shares) | shares | 99,500,000 | |||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 71.09 | |||||||
Milestone PSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Granted (in shares) | shares | 59,500 | |||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 49.32 | |||||||
Number of milestones | milestone | 3 | |||||||
Expiration period | 3 years | |||||||
Expected achievement rate | 0.00% | |||||||
Milestone PSUs | Minimum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Award vesting percentage of target number granted | 0.00% | |||||||
Milestone PSUs | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Award vesting percentage of target number granted | 200.00% | |||||||
Share Repurchase Programs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Payments to repurchase stock | $ 211,200,000 | |||||||
Shares of common stock repurchased (in shares) | shares | 3,782,861 | |||||||
March 2020 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock repurchase program, authorized amount | $ 160,000,000 | |||||||
Accelerated share repurchases, authorized amount | $ 25,000,000 | |||||||
Accelerated share repurchases, payment | $ 25,000,000 | |||||||
Accelerated share repurchases, shares received (in shares) | shares | 550,623 | |||||||
Accelerated share repurchases, initial price paid per share (in dollars per share) | $ / shares | $ 45.40 | |||||||
Fair value adjustments related to derivative instrument | $ 3,000,000 | |||||||
October 2018 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Payments to repurchase stock | $ 68,000,000 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Summary of Stock Options, RSU and PSU Activity (Details) - shares | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock Options | |||
Outstanding beginning balance (in shares) | 3,331,890 | 3,331,890 | 3,096,161 |
Granted (in shares) | 106,000 | 600,700 | |
Options Exercised (in shares) | (94,328) | (38,951) | |
Forfeited or expired (in shares) | (283,998) | (78,478) | |
Outstanding ending balance (in shares) | 3,059,564 | 3,579,432 | |
RSUs | |||
RSUs and PSUs | |||
Outstanding beginning balance (in shares) | 328,396 | 328,396 | 251,215 |
Granted (in shares) | 106,600 | 231,450 | |
Vested (in shares) | (94,273) | (67,970) | |
Forfeited or expired (in shares) | (29,796) | (11,074) | |
Outstanding ending balance (in shares) | 310,927 | 403,621 | |
PSUs | |||
RSUs and PSUs | |||
Outstanding beginning balance (in shares) | 97,750 | 97,750 | 116,181 |
Granted (in shares) | 159,000 | 0 | |
Vested (in shares) | 0 | 0 | |
Forfeited or expired (in shares) | (97,750) | (97,750) | (2,431) |
Outstanding ending balance (in shares) | 159,000 | 113,750 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Compensation - Fair Value of Stock Options Granted (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest minimum rate | 0.51% | 0.44% | ||
Risk-free interest maximum rate | 1.12% | 1.65% | ||
Volatility | 56.10% | 54.94% | ||
Expected term (in years) | 5 years 8 months 1 day | 6 years 10 days | ||
Expected dividend yield | 0.00% | 0.00% | ||
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest minimum rate | 1.01% | 0.44% | ||
Risk-free interest maximum rate | 1.12% | 0.44% | ||
Volatility | 55.66% | 55.46% | ||
Expected term (in years) | 5 years 11 months 15 days | 6 years 29 days | ||
Expected dividend yield | 0.00% | 0.00% |
Common Stock and Stock-Based _6
Common Stock and Stock-Based Compensation - Schedule of Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 4,281 | $ 6,241 | $ 10,789 | $ 13,713 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 3,640 | 5,207 | 9,253 | 11,129 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 641 | 1,034 | 1,536 | 2,584 |
Stock options | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 2,547 | 4,153 | 5,878 | 9,146 |
RSUs | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,217 | 1,334 | 3,005 | 3,186 |
PSUs | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 517 | $ 754 | $ 1,906 | $ 1,381 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating lease | ||||
Total | $ 5,031 | $ 5,031 | ||
2021 | 702 | 702 | ||
2022 | 1,423 | 1,423 | ||
2023 | 1,455 | 1,455 | ||
2024 | 1,038 | 1,038 | ||
2025 | 413 | 413 | ||
2026 | 0 | 0 | ||
Beyond | 0 | 0 | ||
Credit facility | ||||
Total | 30,000 | 30,000 | ||
2021 | 4,000 | 4,000 | ||
2022 | 26,000 | 26,000 | ||
2023 | 0 | 0 | ||
2024 | 0 | 0 | ||
2025 | 0 | 0 | ||
2026 | 0 | 0 | ||
Beyond | 0 | 0 | ||
Purchase obligations | ||||
Total | 48,213 | 48,213 | ||
2021 | 48,213 | 48,213 | ||
2022 | 0 | 0 | ||
2023 | 0 | 0 | ||
2024 | 0 | 0 | ||
2025 | 0 | 0 | ||
2026 | 0 | 0 | ||
Beyond | 0 | 0 | ||
Total obligations | ||||
Total | 83,244 | 83,244 | ||
2021 | 52,915 | 52,915 | ||
2022 | 27,423 | 27,423 | ||
2023 | 1,455 | 1,455 | ||
2024 | 1,038 | 1,038 | ||
2025 | 413 | 413 | ||
2026 | 0 | 0 | ||
Beyond | 0 | 0 | ||
Operating lease, expense | $ 325 | $ 351 | $ 650 | $ 637 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | Nov. 08, 2019 | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | |||
Current portion of long-term debt | $ 8,000,000 | $ 8,000,000 | |
Unamortized deferred debt issuance cost | $ 600,000 | ||
Revised Credit Agreement | Minimum | |||
Debt Instrument [Line Items] | |||
Line of credit facility, commitment fee | 0.35% | ||
Revised Credit Agreement | Maximum | |||
Debt Instrument [Line Items] | |||
Line of credit facility, commitment fee | 0.45% | ||
Revised Credit Agreement | London Interbank Offered Rate (LIBOR) | Minimum | |||
Debt Instrument [Line Items] | |||
Variable interest rate spread | 2.25% | ||
Revised Credit Agreement | London Interbank Offered Rate (LIBOR) | Maximum | |||
Debt Instrument [Line Items] | |||
Variable interest rate spread | 3.00% | ||
Revised Credit Agreement | New York Federal Reserve Bank (NYFRB) | |||
Debt Instrument [Line Items] | |||
Variable interest rate spread | 0.50% | ||
Revised Credit Agreement | Adjusted London Interbank Offered Rate (LIBOR) | |||
Debt Instrument [Line Items] | |||
Variable interest rate spread | 1.00% | ||
Revised Credit Agreement | Prime Rate | Minimum | |||
Debt Instrument [Line Items] | |||
Variable interest rate spread | 1.25% | ||
Revised Credit Agreement | Prime Rate | Maximum | |||
Debt Instrument [Line Items] | |||
Variable interest rate spread | 2.00% | ||
Line of credit | Revised Credit Agreement | |||
Debt Instrument [Line Items] | |||
Draw on line of credit | $ 40,000,000 | ||
Revolving credit facility | Revised Credit Agreement | |||
Debt Instrument [Line Items] | |||
Maximum borrowing capacity | $ 110,000,000 |
Debt - Schedule of Debt Maturit
Debt - Schedule of Debt Maturities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Credit facility | |
2021 (remainder) | $ 4,000 |
2022 | 26,000 |
Total | $ 30,000 |
Income Taxes (Details)
Income Taxes (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)jurisdiction | Jun. 30, 2020USD ($) | |
Income Tax Disclosure [Abstract] | ||||
Income tax provision | $ (1,936,000) | $ (5,629,000) | $ (3,697,000) | $ (5,492,000) |
Effective tax rate | 35.00% | 105.00% | 54.00% | 232.00% |
Number of tax jurisdictions currently auditing the company | jurisdiction | 3 | |||
Unrecognized tax benefits | $ 0 | $ 0 |
Legal Proceedings (Details)
Legal Proceedings (Details) | Dec. 20, 2019patent |
Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc. (Vasopressin) | Pending Litigation | |
Loss Contingencies [Line Items] | |
Number of patents, claims dismissed | 3 |
Collaboration with Tyme (Detail
Collaboration with Tyme (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Fair value gain (loss) | $ 400 | $ (4,200) | ||
Collaborative Arrangement | Tyme | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Fair value gain (loss) | $ (5,200) | $ 2,300 | $ 400 | $ (4,200) |
Convertible Promissory Note (De
Convertible Promissory Note (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Debt Securities, Available-for-sale [Line Items] | |||||
Unrealized loss for convertible promissory note | $ (904,000) | $ 0 | $ (904,000) | $ 0 | |
Embedded derivative asset | 464,000 | 464,000 | |||
Convertible Promissory Note | |||||
Debt Securities, Available-for-sale [Line Items] | |||||
Debt securities, available-for-sale | $ 5,000,000 | $ 5,000,000 | |||
Stated interest rate | 8.00% | 8.00% | |||
Term | 18 months | ||||
Unrealized loss for convertible promissory note | $ 900,000 | ||||
Allowance for credit loss | $ 100,000 | 100,000 | |||
Fair value adjustment on embedded derivative | 200,000 | $ 300,000 | |||
Embedded derivative asset | 500,000 | 500,000 | |||
Initial discount | 300,000 | 300,000 | |||
Interest income | 100,000 | 100,000 | |||
Accrued interest | $ 100,000 | $ 100,000 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent event - AOP Orphan Pharmaceuticals GmbH - Collaborative Arrangement, Transaction with Party to Collaborative Arrangement $ in Millions | Aug. 06, 2021USD ($) |
Subsequent Event [Line Items] | |
Collaborative arrangement, rights and obligations, expected new chemical entity exclusivity | 5 years |
Collaborative arrangement, rights and obligations, upfront payment | $ 5 |