Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 28, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 437,105,101 | ||
Entity Common Stock, Shares Outstanding | 12,697,101 | ||
Documents Incorporated by Reference | Portions of the definitive proxy statement for our 2022 annual meeting of stockholders, which is to be filed within 120 days after the end of the fiscal year ended December 31, 2021, are incorporated by reference into Part III of this Form 10-K, to the extent described in Part III. | ||
Entity Central Index Key | 0000827871 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 |
Audit Information
Audit Information | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2019 | |
Audit Information [Abstract] | ||
Auditor Firm ID | 42 | 243 |
Auditor Name | Ernst & Young, LLP | BDO USA, LLP |
Auditor Location | Stamford, Connecticut | Woodbridge, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 97,659 | $ 103,155 |
Accounts receivable, net | 41,149 | 51,117 |
Inventories | 21,908 | 8,075 |
Prepaid expenses and other current assets | 11,890 | 3,718 |
Total current assets | 172,606 | 166,065 |
Property and equipment, net | 1,636 | 2,077 |
Intangible assets, net | 10,671 | 12,917 |
Goodwill | 39,743 | 39,743 |
Deferred tax asset, net | 18,798 | 15,180 |
Other assets | 10,278 | 17,208 |
Total assets | 253,732 | 253,190 |
Current liabilities: | ||
Accounts payable | 16,431 | 6,268 |
Accrued expenses and other liabilities | 32,338 | 23,817 |
Short-term debt | 25,607 | 8,000 |
Total current liabilities | 74,376 | 38,085 |
Other long-term liabilities | 2,903 | 3,959 |
Long-term debt | 0 | 25,135 |
Total liabilities | 77,279 | 67,179 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of December 31, 2021 and 2020 | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 16,903,034 and 16,739,203 shares issued as of December 31, 2021 and 2020, respectively | 17 | 17 |
Additional paid in capital | 325,779 | 305,403 |
Accumulated other comprehensive loss | (94) | 0 |
Retained earnings | 75,862 | 84,489 |
Treasury stock, at cost, 4,111,622 and 3,682,176 shares as of December 31, 2021 and 2020, respectively | (225,111) | (203,898) |
Total stockholders' equity | 176,453 | 186,011 |
Total liabilities and stockholders' equity | $ 253,732 | $ 253,190 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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) | 16,903,034 | 16,739,203 |
Treasury stock, shares (in shares) | 4,111,622 | 3,682,176 |
Consolidated Statements of Inco
Consolidated Statements of Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Total revenue | $ 171,546 | $ 187,802 | $ 195,892 |
Operating expenses: | |||
Cost, Product and Service [Extensible List] | Product sales, net | Product sales, net | Product sales, net |
Cost of product sales | $ 31,528 | $ 33,647 | $ 47,891 |
Cost of royalty revenue | 10,652 | 11,818 | 13,006 |
Research and development | 51,275 | 30,785 | 36,810 |
Selling, general and administrative | 75,322 | 78,598 | 76,370 |
Total operating expenses | 168,777 | 154,848 | 174,077 |
Income from operations | 2,769 | 32,954 | 21,815 |
Interest income | 560 | 562 | 2,169 |
Interest expense | (1,635) | (2,577) | (2,686) |
Other (expense) income | (6,242) | (8,262) | 700 |
Total other (expense) income, net | (7,317) | (10,277) | 183 |
(Loss) income before income tax provision | (4,548) | 22,677 | 21,998 |
Income tax provision | (4,079) | (10,688) | (7,685) |
Net (loss) income | $ (8,627) | $ 11,989 | $ 14,313 |
(Loss) Earnings per common share: | |||
Basic (in dollars per share) | $ (0.66) | $ 0.89 | $ 1.04 |
Diluted (in dollars per share) | $ (0.66) | $ 0.87 | $ 1.01 |
Weighted average number of common shares outstanding: | |||
Basic (in shares) | 13,051,095 | 13,481,525 | 13,754,516 |
Diluted (in shares) | 13,051,095 | 13,771,393 | 14,138,733 |
Product sales, net | |||
Revenue: | |||
Total revenue | $ 65,023 | $ 72,323 | $ 73,989 |
Royalty revenue | |||
Revenue: | |||
Total revenue | 106,523 | 110,479 | 112,903 |
License and other revenue | |||
Revenue: | |||
Total revenue | $ 0 | $ 5,000 | $ 9,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net (loss) income | $ (8,627) | $ 11,989 | $ 14,313 |
Other comprehensive loss, net of tax: | |||
Unrealized loss for convertible promissory note | (94) | 0 | 0 |
Total other comprehensive loss | (94) | 0 | 0 |
Comprehensive (loss) income | $ (8,721) | $ 11,989 | $ 14,313 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - 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, 2018 | 16,504,000 | |||||
Beginning balance at Dec. 31, 2018 | $ 160,762 | $ 17 | $ 256,458 | $ (153,900) | $ 58,187 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 21,998 | 21,998 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 34,000 | |||||
Issuance of common stock upon exercise of stock option grants | 260 | 260 | ||||
Payment of employee withholding tax upon vesting of stock-based awards | (198) | (198) | ||||
Common stock repurchases | (17,961) | (17,961) | ||||
Other comprehensive loss | 0 | |||||
Net (loss) income | 14,313 | 14,313 | ||||
Ending balance (in shares) at Dec. 31, 2019 | 16,538,000 | |||||
Ending 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 | $ 24,756 | 24,756 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 149,473 | 149,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 3,654 | 3,654 | ||||
Payment of employee withholding tax upon vesting of stock-based awards | (1,525) | (1,525) | ||||
Issuance of common stock related to vesting of restricted stock (in shares) | 52,000 | |||||
Common stock repurchases | (32,037) | (32,037) | ||||
Other comprehensive loss | 0 | |||||
Net (loss) income | 11,989 | 11,989 | ||||
Ending balance (in shares) at Dec. 31, 2020 | 16,739,000 | |||||
Ending 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 | $ 19,555 | 19,555 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 122,847 | 101,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 2,398 | 2,398 | ||||
Issuance of common stock related to vesting of restricted stock (in shares) | 63,000 | |||||
Issuance of common stock related to vesting of restricted stock | (1,577) | (1,577) | ||||
Common stock repurchases | (21,213) | (21,213) | ||||
Other comprehensive loss | (94) | (94) | ||||
Net (loss) income | (8,627) | (8,627) | ||||
Ending balance (in shares) at Dec. 31, 2021 | 16,903,000 | |||||
Ending balance at Dec. 31, 2021 | $ 176,453 | $ 17 | $ 325,779 | $ (225,111) | $ (94) | $ 75,862 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net (loss) income | $ (8,627,000) | $ 11,989,000 | $ 14,313,000 |
Adjustments to reconcile net (loss) income to net cash provided by operating activities: | |||
Deferred income taxes | (3,618,000) | (1,511,000) | 152,000 |
Depreciation expense | 764,000 | 872,000 | 972,000 |
Noncash operating lease expense related to right-of-use assets | 1,046,000 | 1,228,000 | 1,159,000 |
Amortization expense of intangible assets | 2,996,000 | 2,666,000 | 2,520,000 |
Convertible promissory note related credit losses | 758,000 | 0 | 0 |
Stock-based compensation expense | 19,555,000 | 24,756,000 | 21,998,000 |
Fair value adjustments on equity investment | 6,170,000 | 5,300,000 | 0 |
Amortization of debt issuance costs | 472,000 | 419,000 | 480,000 |
Fair value adjustments on settled accelerated share repurchase agreement | 0 | 2,962,000 | 0 |
Fair value adjustments related to derivative instrument | (686,000) | 0 | 0 |
Accretion of discount on convertible promissory note | (148,000) | 0 | 0 |
Changes in operating assets and liabilities which provided (used) cash: | |||
Accounts receivable | 9,529,000 | (3,113,000) | 18,481,000 |
Inventories | (13,833,000) | (1,509,000) | 1,739,000 |
Prepaid expenses and other current assets | (2,770,000) | 11,386,000 | (4,841,000) |
Other assets | (1,321,000) | (2,325,000) | (599,000) |
Accounts payable | 10,162,000 | 806,000 | (4,455,000) |
Accrued expenses and other liabilities | 7,770,000 | (4,429,000) | 4,067,000 |
Net cash provided by operating activities | 28,219,000 | 49,497,000 | 55,986,000 |
Cash flows from investing activities: | |||
Purchase of equity investment security | 0 | (17,500,000) | 0 |
Purchase of property and equipment | (323,000) | (747,000) | (777,000) |
Purchase of convertible promissory note | (5,000,000) | 0 | 0 |
Net cash used in investing activities | (5,323,000) | (18,247,000) | (777,000) |
Cash flows from financing activities: | |||
Repurchases of common stock | (21,213,000) | (34,999,000) | (17,961,000) |
Proceeds from existing revolving credit facility | 0 | 110,000,000 | 0 |
Repayment of existing revolving credit facility | 0 | (110,000,000) | 0 |
Payment of debt | (8,000,000) | (5,000,000) | (6,000,000) |
Payment of debt financing costs | 0 | 0 | (326,000) |
Payment of employee withholding tax upon vesting of stock-based awards | (1,577,000) | (1,525,000) | (198,000) |
Proceeds from common stock option exercises | 2,398,000 | 3,654,000 | 260,000 |
Net cash used in financing activities | (28,392,000) | (37,870,000) | (24,225,000) |
Net (decrease) increase in cash and cash equivalents | (5,496,000) | (6,620,000) | 30,984,000 |
Cash and cash equivalents at beginning of period | 103,155,000 | 109,775,000 | 78,791,000 |
Cash and cash equivalents at end of period | 97,659,000 | 103,155,000 | 109,775,000 |
Cash paid during the period for: | |||
Income taxes, net | 10,005,000 | 6,428,000 | 6,673,000 |
Interest | 1,197,000 | 2,224,000 | 2,478,000 |
Right-of-use asset obtained in exchange for lease obligation, inclusive of a lease amendment | $ 270,000 | $ 855,000 | $ 3,716,000 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | Organization and Business Eagle Pharmaceuticals, Inc. (the "Company", "Eagle", or "we") is 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 the 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, marke ts Treakisym, a RTD product, 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. In December 2021, the FDA approved our first-to-file Abbreviated New Drug Application, or, ANDA for vasopressin, that references Endo International plc’s Vasostrict indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids. Par Pharmaceutical, Inc. (“Par”), subsidiary of Endo International plc then unilaterally withdrew its request that the U.S. District Court for the District of Delaware issue a temporary restraining order and preliminary injunction preventing the launch of our approved vasopressin product. The FDA then determined that we have maintained our 180 days of marketing exclusivity for our approved ANDA for vasopressin. W e launched vasopressin in 2022. Reflecting further expansion of our oncology portfolio, in February 2020, we received final FDA approval for Pemfexy® (“Pemfexy”) and in July 2020, we announced that the Centers for Medicare & Medicaid Services (“CMS”) had established a unique, product-specific billing code for Pemfexy, effective on October 1, 2020. Pemfexy, our novel pemetrexed product, is a branded alternative to Alimta® for metastatic non-squamous non-small cell lung cancer and malignant pleural mesothelioma. The conversion from tentative to a final approval follows the Company’s settlement agreement reached with Eli Lilly and Company (“Lilly”) on December 13, 2019. This agreement provides for a release of all claims by the parties and allows for an initial entry of Pemfexy into the market (equivalent to approximately a three-week supply of current Alimta utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022. Segment Information The Company operates in one reportable business segment because we have a single management team that reports to the Chief Executive Officer, the chief operating decision maker, who comprehensively manages the entire business. The Company does not operate separate lines of business with respect to its products or product candidates. Accordingly, the Company has one reportable segment. Share Repurchase Program As of December 31, 2021, the Company had repurchased an aggregate of 4,111,622 shares of common stock for an aggregate of $228.1 million pursuant to the Company’s share repurchase programs in effect since August 2016. Refer to Note 7. "Common Stock and Stock-Based Compensation" for further details. Long-term Debt On November 8, 2019, the Company entered into the Second Amended and Restated Credit Agreement (the “Revised Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative agent (the “Agent”) and the lenders party thereto, which replaced the Company’s existing credit agreement, dated as of August 8, 2017 (the "Amended Credit Agreement"). Refer to Note 6. "Debt" for further details. Significant License and Collaboration Agreements - Refer to Note 9. "License and Collaboration Agreements" for further details. SymBio License Agreement On September 20, 2017, the Company entered into a Product Collaboration and License Agreement, effective as of September 19, 2017, (the “SymBio License Agreement”) with SymBio Pharmaceuticals Limited (“SymBio”) for the rights to develop and commercialize the Company’s bendamustine hydrochloride ready-to-dilute injection product and rapid infusion injection product (collectively, the “Products”) in Japan. SymBio currently markets in Japan TREAKISYM®, a lyophilized powder formulation of bendamustine hydrochloride indicated for CLL, relapsed or refractory low-grade NHL, mantle cell lymphoma (“MCL”), and as a first line treatment of low-grade NHL and MCL. Under the SymBio License Agreement, SymBio may continue to market TREAKISYM® in Japan and SymBio will be permitted to develop and market certain other bendamustine hydrochloride products in Japan for limited indications. Combioxin License Agreement In August 2021, the Company entered into a license agreement with Combioxin, SA (“Combioxin”) under which the Company was granted exclusive, worldwide development and commercialization rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe pneumonia in combination with traditional antibacterial drugs. The Company will be solely responsible for the development, regulatory, manufacturing and commercialization activities of CAL02. Combioxin will assist the Company in transitioning the manufacturing and supply of CAL02 to the Company. AOP Orphan License Agreement In August 2021, the Company 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. The Company will support the submission of a new drug application by AOP Orphan to the FDA seeking approval for Landiolol for the short term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. Products and Product Candidates Overview Bendeka In March 2018, the FDA approved a second manufacturing site for Bendeka. On May 15, 2018, the FDA granted final approval for Eagle's ready-to-dilute bendamustine hydrochloride solution in a 500ml admixture for the treatment of patients with chronic lymphocytic leukemia (“CLL”) and patients with indolent B-cell non-Hodgkin lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. On March 24, 2016 the FDA denied the Company's request for seven years of orphan drug exclusivity in the U.S., for Bendeka. In April 2016, the Company filed a lawsuit against the FDA arguing that Bendeka is entitled to orphan drug exclusivity as a matter of law (see Note 13. Legal Proceedings). On July 2, 2014, the FDA granted the Company orphan drug designations for Bendeka for the treatment of CLL and indolent B-cell NHL. The designations were based on a plausible hypothesis that Bendeka is “clinically superior” to a drug previously approved for the same indications. Generally, an orphan-designated drug is eligible for seven years of marketing exclusivity for the orphan-designated indications upon approval of the drug for those indications. On June 8, 2018, the U.S. District Court for the District of Columbia (the “Court”) issued a decision requiring the FDA to grant seven years of orphan drug exclusivity (“ODE”) in the U.S., for Bendeka, and on July 8, 2018 the FDA granted such ODE through December 2022. In addition, on July 8, 2018, the FDA submitted a Motion to Alter or Amend the Judgement Pursuant to Rule 59(e), pursuant to which the FDA requested the Court amend its decision to make clear that the decision does not affect any applications referencing TREANDA. The FDA’s motion was denied by the Court on August 1, 2018 on the grounds that FDA was seeking an inappropriate advisory opinion. On February 20, 2019, the FDA issued a decision in favor of the Company, regarding the scope of exclusivity for Bendeka. Pursuant to the decision, no bendamustine product (including generic versions of TREANDA) may launch in the United States until December 7, 2022 unless it is clinically superior to Bendeka. The Company expects to vigorously pursue the scope of its exclusivity grant. As of March 29, 2019, the Company and Teva Pharmaceutical Industries Ltd. ("Teva") executed an amendment to the Cephalon License Agreement to terminate Teva's obligation to pay future milestones and royalties on Bendeka sales outside of the U.S., which included an upfront cash payment of $9 million that was recorded as License and other revenue on the consolidated statements of operations. On April 13, 2019, the Company and Teva entered into an Amendment to the Cephalon License Agreement ("Cephalon License", amending the terms of the License Agreement to increase the U.S. royalty paid to the Company and re-allocated certain litigation expenses. Pursuant to the Amendment, beginning on October 1, 2019, the Company's royalty payment has increased from 25% to 30% of Bendeka net U.S. sales. The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter. The Amendment also extends the U.S. royalty term for Bendeka until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. The extended term coincides with the bendamustine patents with expiries through 2033. Pursuant to the amendment, Eagle will continue to be responsible for the manufacture of Bendeka for the U.S. market for so long as it is sold in the United States. Ryanodex On October 3, 2018, the Company announced that it entered into an agreement with the United States Army Medical Research Institute of Chemical Defense, the nation’s leading science and technology laboratory in the area of medical chemical countermeasures research and development, to conduct a study to evaluate the neuroprotective effects of Ryanodex® (dantrolene sodium). On May 7, 2019, the Company announced positive results of its study to evaluate the neuroprotective effects of Ryanodex secondary to nerve agent exposure, conducted with the United States Army Medical Research Institute of Chemical Defense. On December 16, 2019, we announced that the FDA has granted orphan drug designation (ODD) for Ryanodex®(dantrolene sodium) for the treatment of organophosphate exposure. Organophosphates are a class of chemicals that include potent pesticides and chemical weapons, known as nerve agents. Acute intoxication with organophospates may result in severe consequences, including brain damage and death. About 2,700 people in the United States are treated for accidental exposure to organophosphate pesticides every year. Eagle is currently evaluating Ryanodex for the treatment of brain damage secondary to nerve agent exposure. If approved, Ryanodex would represent the first product available for this indication. On January 6, 2020, we issued a press release announcing a new research agreement with NorthShore University HealthSystem in Evanston, Illinois, focused on studying Ryanodex for traumatic brain injury (TBI) in animal models. TBI can acutely cause brain lesions that result in direct tissue damage that may prompt apoptotic cell mechanisms for several weeks post-injury, which may lead to worsened long-term outcomes. Disruption of certain intracellular mechanisms may affect cell functioning and survival. Fulvestrant On October 30, 2018, the Company announced that the Company’s fulvestrant formulation has not met the primary pharmacokinetic endpoint evaluating the bioequivalence of the Company’s formulation compared to Faslodex in its open label, randomized, pharmacokinetic and safety study conducted in 600 healthy female volunteers across multiple U.S. sites. On May 7, 2019, the Company announced positive results of its study to evaluate the neuroprotective effects of Ryanodex secondary to nerve agent exposure, conducted with the United States Army Medical Research Institute of Chemical Defense. PEMFEXY On February 1, 2022, the Company announced the commercial availability of its novel product PEMFEXY™ (pemetrexed for injection) in the United States. A branded alternative to ALIMTA®, PEMFEXY is a ready-to-use liquid with a unique J-code, approved to treat nonsquamous non-small cell lung cancer and mesothelioma. Previously, in February 2020, the Company received final approval from the FDA of its NDA for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019. The agreement provided for a release of all claims by the parties and allowed for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of ALIMTA utilization) on February 1, 2022 and a subsequent uncapped entry on April 1, 2022. Under the settlement agreement, we will pay a royalty equal to one percent of the net sales of PEMFEXY during the royalty term, which will end no later than May 24, 2022. Tyme On January 7, 2020, Tyme Technologies, Inc. and the Company announced a strategic collaboration to advance o ral SM-88 for the treatment of patients with cancer. SM-88 was an investigat ional agent in two Phase 2 studies for pancreatic cancer and in a Phase 2 study for prostate cancer. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies 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 t he second quar ter 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 certain litigation 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 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. Revenue from sales of products is recognized at the point where the customer obtains control of the goods and we satisfy our performance obligation, which generally is at the time we ship the product to the customer. Provisions for chargebacks, rebates, discounts, and returns are established in the same period the related sales are recognized. Significant judgments must be made in determining the transaction price for our sales of products related to anticipated rebates, discounts and returns. Refer below for further details. 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 The Company considers cash and cash equivalents to be highly liquid investments with an original maturity of three months or less from the date of purchase. 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 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. The following tables present the Company’s hierarchy for its assets measured at fair value as of December 31, 2021 and 2020: December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Tyme 6,030 6,030 — — Total financial assets $ 68,370 $ 63,387 $ — $ 4,983 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 $ — $ — The Company recognizes 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 years ended December 31, 2021 and 2020, respectively. Our investment in the convertible promissory note and the embedded derivative are classified as Level 3. We analyzed and assessed 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 14, Convertible Promissory Note for further details. Our investment in restricted shares of common stock of Tyme Technologies, Inc. (“Tyme”) are classified as Level 1. Refer to Note 9, "License and Collaboration Agreements" 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 Finite-lived intangible assets are measured at their respective fair values on the date they were recorded at the date of subsequent adjustments of fair value and stated net of accumulated amortization. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. The Company amortizes its definite-lived intangible assets using either the straight-line or accelerated method, based on the useful life of the asset over which it is expected to be consumed utilizing expected undiscounted future cash flows. The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment significant changes in our forecasted projections for the asset or asset group for reasons including, but not limited to, significant under-performance of a product in relation to expectations, significant changes or planned changes in our use of the assets, significant negative industry or economic trends, and new or competing products that enter the marketplace. If such indicators are present, the Company assesses 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, the Company measures the amount of the impairment by comparing 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 December 31, 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 fair value of the reporting unit’s goodwill is less than it's carrying amount. The Company performed a qualitative annual test for goodwill as of October 1, 2021. During the year ended December 31, 2021, the Company concluded that no impairment exists. Concentration of Major Customers and Vendors The Company is dependent on its commercial partner to market and sell Bendeka; therefore, the Company's future revenues are highly dependent on the collaboration and distribution arrangement with Teva. Teva markets Bendeka through a license agreement with the Company. Pursuant to that license agreement, Teva pays the Company a royalty based on net sales of the product and also purchases the product from the Company. A disruption in this arrangement, caused by, among other things, a supply disruption, loss of exclusivity or the launch of a superior product would have a material adverse effect of the Company’s financial position, results of operations and cash flows. The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Year Ended December 31, 2021 2020 2019 Net revenues Cephalon, Inc. (Teva) - See Revenue Recognition 66 % 67 % 77 % Other 34 % 33 % 23 % 100 % 100 % 100 % December 31, 2021 2020 Accounts receivable Cephalon, Inc. (Teva) - See Revenue Recognition 63 % 58 % Other 37 % 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. The Company periodically reviews the composition of its inventories 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 inventories, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. Property and Equipment Property and equipment are stated at cost. Depreciation is recorded over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. 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 the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $2.6 million, $2.7 million, and $2.4 million for the year ended December 31, 2021, 2020, and 2019, respectively. Income Taxes The Company accounts for income taxes using the liability method in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 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 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 the 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, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies 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, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue. Product revenue - The Company recognizes net revenue on sales to its commercial partners and to end users. In each instance, revenue is generally recognized when the customer obtains control of the Company’s 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. 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. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price generally utilizing the expected value method to which the Company expects to be entitled. As such, revenue on sales to end users 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 allowance for chargebacks and rebate reserves. The Company has a product returns policy on some of its 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. The Company's 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. The Company has terms on sales of Ryanodex by which the Company does not accept returns. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made generally using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company believes that the estimates it has 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 the Company's distributors. The Company's 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 the Company’s 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 : The Company contracts 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. The Company estimates the rebates it 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. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s 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 the Company’s distributors. The information that the Company also considers when establishing its 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. The Company regularly reviews and monitors estimated or actual customer inventory information at its largest distributors for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : The Company's provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. The Company’s 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. The Company estimates future product returns on sales of Belrapzo based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iii) historical industry information regarding return rates for similar pharmaceutical products, (iv) the estimated remaining shelf life of Belrapzo previously shipped and currently being shipped to distributors and (v) contractual agreements intended to limit the amount of inventory maintained by the Company’s 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 consolidated balance sheets. Wholesaler fees and other incentives : The Company generally provides invoice discounts on Belrapzo and Ryanodex sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. 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, the Company expects its distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. The Company recorded product sales, net as follows: Year Ended December 31, 2021 2020 2019 (in thousands) Bendeka $ 11,167 $ 15,439 $ 31,182 Belrapzo 23,728 27,527 29,665 Ryanodex 25,271 28,268 13,039 Other 4,857 1,089 103 Product sales, net $ 65,023 $ 72,323 $ 73,989 The following table provides a summary roll-forward of the Company's net product revenue allowances and related reserves for the years ended December 31, 2021 and 2020, on the consolidated balance sheets (in thousands): Chargebacks Commercial Rebates Medicaid Rebates Product Returns Wholesaler Fees and Other Incentives Total Balance at December 31, 2019 $ 2,988 $ 1,131 $ 567 $ 2,403 $ 2,011 $ 9,100 Provisions / Adjustments 20,368 1,243 484 (391) 8,526 30,230 Charges processed / Payments (21,067) (602) (367) (346) (5,146) (27,528) Balance at December 31, 2020 $ 2,289 $ 1,772 $ 684 $ 1,666 $ 5,391 $ 11,802 Provisions / Adjustments 27,402 3,042 268 2,531 9,650 42,893 Charges processed / Payments (25,852) (2,838) (332) (2,674) (13,070) (44,766) Balance at December 31, 2021 $ 3,839 $ 1,976 $ 620 $ 1,523 $ 1,971 $ 9,929 Such net product revenue allowances and reserves are included within accounts receivable, net and accrued expenses and other current liabilities within the consolidated balance sheets. Royalty Revenue — The Company recognizes revenue from license arrangements with its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 25 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. Our receivables from royalty revenue are due 45-days from the end of the quarter. License and other revenue — The Company analyzes each element of its 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. The Company recognizes 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. The Company determines 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, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes 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, the Company 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, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, the Company 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, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of December 31, 2021. Stock-Based Compensation The Company utilize stock-based compensation in the form of stock options, restricted stock units ("RSUs") and performance-based stock units ("PSUs"), each of which may be granted separately or in tandem with other awards. Compensation expense is recognized in the Consolidated Statements of operations based on the estimated fair value of the awards at grant date ratably over the requisite service period, which generally equals the vesting period of the award. The grant-date fair value of stock awards is based upon the underlying price of the stock on the date of grant. The grant-date fair value of stock option awards must be determined using an option pricing model. The Company uses the Black-Scholes option pricing formula for determining the grant-date fair value of such awards. Option pricing models require the use of estimates and assumptions as to (a) the expected term of the option, (b) the expected volatility of the price of the underlying stock and (c) the risk-free interest rate for the expected term of the option. The Company may also grant performance-based stock awards to employees from time-to-time in form of market condition or performance condition. The grant-date fair value of awards that vest based on achievement of certain market condition are determined using a Monte Carlo simulation technique. The grant-date fair value of awards that vest based on achievement of certain performance condition are determined using the accelerated attribution method once it is probable that the performance condition will be achieved. 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, |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The Company's inventory balance consists of the following: December 31, 2021 2020 Raw materials $ 7,317 $ 3,515 Work-in-process 9,666 2,589 Finished goods 4,925 1,971 $ 21,908 $ 8,075 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment consists of the following: December 31, Estimated Useful Life (years) 2021 2020 Furniture and fixtures $ 1,525 $ 1,476 7 Office equipment 1,077 1,152 3 Equipment 3,834 3,485 7 Leasehold improvements 1,155 1,155 2 7,591 7,268 Less accumulated depreciation (5,955) (5,191) Property and equipment, net $ 1,636 $ 2,077 |
Balance Sheet Accounts
Balance Sheet Accounts | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Prepaid expenses and Other Current Assets Prepaid and other current assets consist of the following: December 31, 2021 2020 Advances to commercial manufacturers $ 942 $ 660 Prepaid FDA user fee and advances to CROs 1,108 1,262 Prepaid insurance 196 191 Prepaid income taxes 1,173 — Convertible promissory note, net 5,312 — All other 3,159 1,605 Total Prepaid expenses and other current assets $ 11,890 $ 3,718 Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consist of the following: December 31, 2021 2020 Royalties payable to commercial partners $ 5,085 $ 5,996 Accrued research & development 4,100 2,724 Accrued professional fees 2,013 2,370 Accrued salary and other compensation 8,466 4,686 Accrued product sales reserves 4,390 4,966 Current portion of lease liability 1,309 1,123 All other 6,975 1,952 Total Accrued expenses and other liabilities $ 32,338 $ 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, and a new office space located in Palm Beach Gardens, FL. The new lease agreement commenced on November 1, 2021 and will expire 36 months from the lease commencement date, which is October 31, 2024. All of our leases are classified as operating leases and have remaining lease terms of approximately 3.1 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 the Company's total lease costs included in the consolidated financial statements, as well as other required quantitative disclosures (in thousands): As of December 31, July 13, 1905 July 12, 1905 Operating lease cost $ 1,407 $ 1,323 Total lease cost $ 1,407 $ 1,323 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 1,407 $ 1,323 Right-of-use assets obtained in exchange for new operating lease liabilities $ 270 $ 855 Weighted-average remaining lease term - operating leases 3.1 years 4.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % Year Ending December 31, Operating Leases 2022 1,423 2023 1,455 2024 1,038 2025 413 Thereafter — Total 4,329 Less: present value discount (116) Present value of lease liabilities $ 4,213 Balance Sheet Classification as of December 31, 2021 Current lease liabilities (included with Accrued expenses and other liabilities) $ 1,309 Long-term lease liabilities (included with Other long-term liabilities) 2,904 Total lease liabilities $ 4,213 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Debt On November 8, 2019, the Company entered into the Second Amended and Restated Credit Agreement (the “Revised Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative agent (the “Agent”) and the lenders party thereto, which replaced the Company’s existing credit agreement, dated as of August 8, 2017 (the "Amended Credit Agreement"). The terms and amounts borrowed under the Revised Credit Agreement includes a drawn term loan of $40 million and a undrawn revolving credit facility of $110 million. The schedule of principal payments for the new term loan facility has been extended until November 8, 2022. The Company classified the current portion of long-term debt of $26 million on the consolidated balance sheet as of December 31, 2021. Per the terms of the Revised Credit Agreement, the Company is limited in its ability to pay dividends. As of December 31, 2021, the Company was in compliance with each of the senior secured net leverage ratio; total net leverage ratio; and fixed charge coverage ratio covenants. The new term loan facility shall bear 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 the Company may amend the Revised Credit Agreement to replace the LIBOR with a Benchmark Replacement, described below. Loans under the Revised 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 Revised 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. The Company is required to pay a commitment fee on the unused portion of the new revolving credit facility in the Revised Credit Agreement at a rate ranging from 0.35% to 0.45% per annum based upon the total net leverage ratio. As of December 31, 2021, the Company had $0.4 million of unamortized deferred debt issuance costs in its consolidated balance sheets. Debt Maturities As of December 31, 2021 2022 $ 26,000 Total $ 26,000 |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Common Stock and Stock-Based Compensation | Common Stock and Stock-Based Compensation Common Stock On March 17, 2020, the Company, announced that its Board approved a new share repurchase program, or the Share Repurchase Program, providing for the repurchase of up to an aggregate of $160.0 million of the Company’s outstanding common stock. The Share Repurchase Program replaced the Company’s 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, the Company had repurchased approximately $68.0 million of the Company’s outstanding common stock under the Previous Share Repurchase Program. Under the Share Repurchase Program, the Company is 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 the Company’s cash resources. On September 23, 2020, the Company's Board of Directors approved a $25.0 million accelerated share repurchase (“ASR”) transaction with JPMorgan Chase Bank, National Association (“JP Morgan”) as part of the Company’s existing $160.0 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 the Company’s common stock, less a discount, during the term of the ASR program. Under the terms of the Company's agreement with JP Morgan, the Company paid $25.0 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 the Company’s 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. The Company determined the ASR contained a forward contract and therefore the Company recorded fair value adjustments on the accelerated share repurchase agreement in the amount of $3.0 million which was a loss recorded in Other expense on our consolidated statements of operations in the year ended December 31, 2020. As of December 31, 2021, the Company had repurchased an aggregate of 4,111,622 shares of common stock for an aggregate of $228.1 million pursuant to the Company’s share repurchase programs in effect since August 2016. We repurchased the following shares of common stock with cash resources: Year Ended December 31, 2021 2020 2019 Shares of common stock repurchased 429,446 774,489 317,429 Cash paid for r epurchases of common stock $ 21,213 $ 34,999 $ 17,961 Stock-Based Compensation In December 2007, the Company's board of directors approved the 2007 Incentive Compensation Plan (the "2007 Plan") enabling the Company to grant multiple stock-based awards to employees, directors and consultants, the most common being stock options and restricted stock awards. In November 2013, the Company's board of directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2007 Plan was terminated upon the effectiveness of the 2014 Plan and all shares available for issuance under the 2007 Plan were made available under the 2014 Plan. 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 is 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. At the Company's annual meeting of stockholders held on August 4, 2015, the stockholders approved an amendment to the 2014 Plan to, among other things, increase the number of shares of common stock authorized for issuance thereunder by 500,000 shares. After accounting for such increase, and as of such amendment, the Company has reserved and made available 1,934,193 shares of common stock for issuance under the 2014 Plan. During the year ended December 31, 2018, the Company introduced a new long-term incentive program with the objective to better align the share-based awards granted to management with the Company's focus on improving total shareholder return over the long-term. The share-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 that vest upon achievement of certain share price appreciation conditions. These share-based awards expired in January 2021. Stock Options The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, 2021 2020 2019 Risk-free interest rate 0.51% - 1.26% 0.37% - 1.65% 1.42% - 2.61% Volatility 52.87% - 60.02% 54.89% - 55.51% 40.83% Expected term (in years) 5.50 - 6.08 years 5.50 - 6.08 years 1.51 - 9.41 years Expected dividend yield 0.0% 0.0% 0.0% The following table summarizes information about stock option activity related to the 2014 Plan: Number of Weighted Non- Exercisable Outstanding at December 31, 2019 3,096,161 $ 59.29 1,070,054 2,026,107 Granted 762,200 $ 55.76 Exercised (149,473) $ 24.43 Forfeited or expired (376,998) $ 66.71 Outstanding at December 31, 2020 3,331,890 $ 59.20 1,028,142 2,303,748 Granted 114,000 $ 46.74 Exercised (122,847) $ 27.64 Forfeited or expired (508,165) $ 62.00 Outstanding at December 31, 2021 2,814,878 $ 58.51 472,916 2,341,962 The weighted-average grant-date fair value of options granted during the year ended December 31, 2021, 2020, and 2019 was $23.62, $28.98, and $22.18, respectively. As of December 31, 2021, there was $8,853 unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 2.0 y ears. The total intrinsic value of options exercised during the year ended December 31, 2021 was $2,434. The weighted average contractual terms of options outstanding as of December 31, 2021, 2020, and 2019 was 5.2, 6.1, and 6.8 years, respectively. The aggregate pre-tax intrinsic value of options outstanding as of December 31, 2021, 2020, and 2019 was $13.8 million, $11.6 million, and $31.9 million, respectively. RSUs Each vested time-based RSU represents the right of a holder to receive one of the Company’s common shares. The fair value of each RSU granted was estimated based on the trading price of the Company’s common shares on the date of grant. The following table summarizes information about RSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2019 251,215 $ 44.84 Granted 236,450 $ 59.48 Vested (79,420) $ 46.78 Forfeited (79,849) $ 52.76 Non-vested at December 31, 2020 328,396 $ 53.09 Granted 106,600 $ 48.55 Vested (95,523) $ 52.26 Forfeited (76,167) $ 52.29 Non-vested at December 31, 2021 263,306 $ 51.77 As of December 31, 2021, there was $7,562 of unrecognized stock-based compensation expense related to non-vested RSUs that is expected to be recognized over a weighted average period of 2.3 years. PSUs 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 RSUs and 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 ended December 31, 2021. The following table summarizes information about PSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2019 116,181 $ 90.19 Granted — $ — Vested — $ — Forfeited (18,431) $ 90.19 Non-vested at December 31, 2020 97,750 $ 90.19 Granted 159,000 $ 62.94 Vested — $ — Forfeited (119,450) $ 84.90 Non-vested at December 31, 2021 137,300 $ 63.24 The Company recognized stock-based compensation in its consolidated statements of operations for the year ended December 31, 2021, 2020, and 2019 as follows: Year Ended December 31, 2021 2020 2019 Stock options $ 11,521 $ 17,694 $ 16,394 PSUs 2,729 1,635 3,062 RSUs 5,305 5,427 2,542 Stock-based compensation expense $ 19,555 $ 24,756 $ 21,998 Selling, general and administrative $ 16,873 $ 22,074 $ 17,556 Research and development 2,682 2,682 4,442 Stock-based compensation expense $ 19,555 $ 24,756 $ 21,998 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of our provision from income taxes is as follows: Year Ended December 31, 2021 2020 2019 Current: Federal $ 6,912 $ 10,140 $ 6,689 State 785 2,059 844 $ 7,697 $ 12,199 $ 7,533 Deferred: Federal (3,030) (1,227) 392 State (588) (284) (240) $ (3,618) $ (1,511) $ 152 Provision for income taxes $ 4,079 $ 10,688 $ 7,685 The reconciliation of the statutory U.S. Federal income tax rate to the Company's effective income tax rate is as follows; Year Ended December 31, 2021 2020 2019 U.S. Federal statutory tax rate 21 % 21 % 21 % State income taxes, net of federal benefit (1) % 6 % 2 % Tax effect on stock option exercises, net of forfeitures (44) % 4 % 1 % R&D tax credits and Orphan Drug credits 31 % (2) % (2) % Limitation on executive compensation (60) % 9 % 10 % Change in valuation allowance (40) % 9 % 4 % Foreign rate differential 4 % (1) % (2) % Other (1) % 1 % 1 % Effective tax rate (90) % 47 % 35 % The effective tax rate for the year ended December 31, 2021, reflects certain non-deductible executive compensation, tax effect on stock option exercises, net of forfeitures and valuation allowance established on the deferred tax asset for an unrealized capital loss in our investment in Tyme partially offset by credits for research and development activities. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets were as follows: December 31, 2021 2020 Deferred tax assets Net operating loss carryforward $ 1,563 $ 841 Stock based compensation 10,405 12,015 Other asset - equity investment with readily determined fair value 3,190 1,771 Inventories 2,123 2,338 Employee-related expenses 1,240 51 Intangible assets 4,207 708 Right-of-use liability 962 1,154 R&D tax credit carryforwards 329 86 Other 1,489 1,216 Total deferred tax assets 25,508 20,180 Deferred tax liabilities Installment sale - Malta 485 483 Prepaid expenses 45 43 Fixed assets 300 315 Lease liability 921 1,092 Total deferred tax liabilities 1,751 1,933 Valuation allowance (4,959) (3,067) Net deferred tax assets $ 18,798 $ 15,180 In July 2006, the Financial Accounting Standards Board (“FASB”) issued ASC 740-10, Uncertainty in Income Taxes, which defines the threshold for recognizing the benefits of tax-return positions in the financial statements as “more-likely-than-not” to be sustained by the taxing authorities. This statement also requires explicit disclosure requirements about a Company’s uncertainties related to their income tax position, including a detailed roll forward of tax benefits taken that do not qualify for financial statement recognition. The Company files income tax returns in the U.S. federal jurisdiction and several states. The Company is under audit by the Internal Revenue Service and three states tax jurisdiction as of December 31, 2021. The Company has no amount recorded for any unrecognized tax benefits as of December 31, 2021. The Company regularly evaluates its 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. As of December 31, 2021, the Company has a net operating loss ("NOL") carryforward in Malta of $4.5 million which has no expiration date and can be carried forward indefinitely until utilized. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements License Agreements License agreement with Combioxin In August 2021, we entered into a license agreement with Combioxin, SA under which the Company was granted exclusive, worldwide development and commercialization rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe pneumonia in combination with traditional antibacterial drugs. The Company will be solely responsible for the development, regulatory, manufacturing and commercialization activities of CAL02. Combioxin will assist the Company in transitioning the manufacturing and supply of CAL02 to the Company. Under the terms of the agreement, we paid $10 million as upfront license consideration that was expensed immediately as research and development and is reflected within the operating activities of the condensed consolidated statements of cash flows. The Company may pay to Combioxin up to $105 million upon achievement of certain development, regulatory and sales based milestone payments plus royalty payments at royalty rates ranging in low double digit percentages on the net sales of all products sold, subject to certain adjustments as provided in the agreement. The Company is also obligated to make certain payments based upon amounts received by sublicensees under the agreement. License agreement with AOP Orphan In August 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. Under the terms of the agreement, we paid $5 million as upfront license consideration that was expensed immediately as research and development and is reflected within the operating activities of the condensed consolidated statements of cash flows . The Company may pay to AOP Orphan up to $25 million upon achievement of certain regulatory milestone payments plus profit share payments, subject to certain adjustments as provided in the agreement. We also entered into a supply agreement at the same time as the licensing agreement. Collaboration with Tyme On January 7, 2020, Tyme and we announced a strategic collaboration to advance SM-88, an oral product candidate for the treatment of patients with cancer. SM-88 was an investigational agent in two Phase II studies, one for pancreatic cancer and another for prostate cancer. On January 26, 2022, Tyme announced the discontinuation of SM-88 with methoxsalen, phenytoin, and sirolimus in a trial for metastatic pancreatic cancer. On February 11, 2022, Tyme stated SM-88 is being evaluated in a Phase II study evaluating SM-88 in breast cancer (HR+/HER2-), as well as continuing enrollment of a Phase II study in high-risk metastatic sarcomas Under the terms of a related co-promotion agreement, we would be responsible for 25% of the promotional sales effort of SM-88 and would receive 15% royalty on the net revenues of SM-88 in the United States. Tyme is responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. Tyme retains the remaining 85% of net U.S. revenues and reserves the right to repurchase our U.S. co-promotion right for $200.0 million. Our equity investment in Tyme is included in Other assets on our consolidated balance sheet. For the years ended December 31, 2021 and 2020, the fair value adjustments for the equity investment was a loss of $6.2 million and a loss of $5.3 million, respectively. These adjustments were recorded in Other (expense) income on our consolidated statements of operations. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Our future material contractual obligations include the following: Obligation Total 2022 2023 2024 2025 Operating leases (1) $ 4,329 $ 1,423 $ 1,455 $ 1,038 $ 413 Credit facility 26,000 26,000 — — — Purchase obligations (2) 69,549 69,549 — — — Total obligations $ 99,878 $ 96,972 $ 1,455 $ 1,038 $ 413 (1) We lease our corporate office location. On August 8, 2019, we amended the lease for our corporate office location in order to rent additional office space and extend the term of our existing lease to June 30, 2025. The Company also leases its lab space under a lease agreement that expires on April 30, 2024. We also lease office space located in Palm Beach Gardens, FL. The new lease agreement commenced on November 1, 2021 and will expire 36 months from the lease commencement date, which is October 31, 2024. Rental expense was $1,407, $1,323, and $1,146, for the years ended December 31, 2021, 2020, and 2019, respectively. The remaining future lease payments under the operating leases, exclusive of any renewal option periods, are $4,329 as of December 31, 2021, payable monthly. December 31, 2021 Total operating lease payments $ 4,329 Less: imputed interest (116) Total lease liabilities $ 4,213 (2) As of December 31, 2021, the Company has purchase obligations in the amount of $69,549 which represents the contractual commitments under contract manufacturing and supply agreements with suppliers. The obligation under the supply agreement is primarily for finished product, inventory, and research and development. |
Related Party Transaction
Related Party Transaction | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transaction On May 10, 2019, Hudson Executive Capital LP ("Hudson Capital") sold 100,000 shares of the Company's common stock and the Company purchased those 100,000 shares in a block trade at a price of $56.14 per share. Douglas Braunstein is the Managing Partner of Hudson Capital and was a member of Eagle’s Board of Directors at the time of the transaction. |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 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: December 31, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charges Net Book Value Ryanodex intangible 18.5 $ 15,000 $ (5,079) $ — $ 9,921 Developed technology 5 8,100 (8,100) — — Vasopressin Milestone 1 750 — — 750 Total $ 23,850 $ (13,179) $ — $ 10,671 December 31, 2020 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charge Net Book Value Ryanodex intangible 20 15,000 (3,500) — 11,500 Developed technology 5 8,100 (6,683) — 1,417 Total $ 23,100 $ (10,183) $ — $ 12,917 Amortization expense amounted to $3.0 million, $2.7 million, and $2.5 million, for the year ended December 31, 2021, 2020, and 2019, respectively. Estimated Useful Lives The Company reviews the estimated useful lives of its intangible assets on a periodic basis. The review indicated that the actual life of the Ryanodex intangible asset was shorter than the estimated useful life used for amortization purposes in the Company’s financial statements. As a result, the estimated useful life of the Ryanodex related intangible assets was shortened from 2036 to 2025. The change in the estimated useful life is considered a change in accounting estimate and will result in changes to the Company's amortization expense prospectively. As of December 31, 2021, the net carrying value of the Ryanodex related intangible assets was $9.9 million. The effect of this change in estimate increased the 2021 amortization expense by $0.4 million. Impairment Assessment The Company reviews the recoverability of its 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, the Company 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, the Company measures 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 at December 31, 2021 and 2020. Estimated Amortization Expense for Intangible Assets Based on definite-lived intangible assets recorded as of December 31, 2021, and assuming that the underlying assets will not be impaired and that the Company will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2022 3,073 2023 2,785 2024 2,511 2025 2,302 All other — Total estimated amortization expense $ 10,671 |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 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 is scheduled for April 2022. Patent Litigation 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. On August 13, 2021, the appeals court affirmed the trial court’s decision. The mandate was issued on October 22, 2021. Apotex filed a petition for certiorari on December 14, 2021, which the Supreme Court denied on February 22, 2022. 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 ongoing. Trial has been rescheduled for April 25, 2022. The case remains pending. Patentees filed suit against Hospira, Inc. on November 16, 2021. Patentees have asserted U.S. Patent No. 11,103,483. Hospira filed its Answer on December 8, 2021. Scheduling for the case is ongoing. The parties submitted disputed scheduling proposals on February 15, 2022, a decision on which is currently pending before the Court. 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. On October 20, 2021, the Court entered a stipulation of dismissal based on a settlement between the parties 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 was filed August 16, 2021. On December 27, 2021, Dr. Reddy’s moved for judgment on the pleadings, seeking a dismissal of all patents except the ‘887 patent. On January 27, 2022, the Court entered an agreed stipulation by the parties dismissing all patents except the ‘887. On February 8, 2022, consistent with that stipulation, Patentees filed an Amended Complaint removing the dismissed patents and adding U.S. Patent No 11,103,483. Dr. Reddy’s filed its Answer and Counterclaims to that Amended Complaint on February 22, 2022. Patentees’ Counterclaim Answer is due March 15, 2022.Fact discovery is ongoing, and the case is set for trial on May 1, 2023. 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. On January 13, 2022, Accord filed a Motion to Dismiss for failure to state a claim. On January 26, 2022, Patentees filed a First Amended Complaint, removing all patents except the ‘887 patent and additionally asserting U.S. Patent No. 11,103,483. Accord filed its Answer and Counterclaims to that Amended Complaint on February 10, 2022. On February 28, 2022, Patentees filed their Answer to Accord’s Counterclaims. Scheduling for the case is ongoing and a proposed schedule is due to the Court on March 16, 2022 Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company - ( Belrapzo ® ) 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. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company, Apotex, Inc. and Apotex Corp., Celerity Pharmaceuticals, LLC - (BELRAPZO ® ) Slayback, Apotex, and Celerity Pharmaceuticals, LLC (“Celerity”) filed NDAs referencing Eagle’s Belrapzo NDA. The Company filed suits against Slayback, Apotex, and Celerity in the United States District Court for the District of Delaware on August 31, 2021 (Slayback and Apotex) and on January 11, 2022 (Celerity) alleging infringement of U.S. Patent No. 11,103,483. On September 22, 2021, both Slayback and Apotex filed their Answers. The suit against Slayback and Apotex is set for trial on October 26, 2022, and fact discovery is ongoing. On February 2, 2022, Celerity moved to dismiss the pending complaint. In response, the Company filed an Amended Complaint on March 1, 2022. Celerity’s response is due March 15, 2022. 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 Court issued an opinion on August 31, 2021 and entered a final judgment of non-infringement in favor of Eagle on September 16, 2021. Par filed a Notice of Appeal of the final judgment on September 22, 2021, and the appeal was docketed with the United States Court of Appeals for the Federal Circuit on September 23, 2021. Par filed its principal appeal brief on December 6, 2021, Eagle filed its responsive appeal brief on February 1, 2022, and Par filed its reply appeal brief on February 22, 2022. The 30-month stay of FDA approval expired on October 17, 2020. The FDA approved Eagle’s ANDA on December 15, 2021. On December 16, 2021, Par filed an emergency motion for temporary restraining order and preliminary injunction in the district court to enjoin Eagle from launching its product, but Par voluntarily withdrew the motion on December 20, 2021. Eagle commercially launched its ANDA product in January 2022. 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. |
Convertible Promissory Note
Convertible Promissory Note | 12 Months Ended |
Dec. 31, 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. The following table summarizes the amounts recorded and activity during the year ended December 31, 2021; Initial Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative December 31, 2021 Fair value of the note $ 5,000 $ (94) $ — $ — $ — $ — $ 4,906 Discount on the note (276) — 149 — — — (127) Estimated Credit Loss — — — (758) — — (758) Convertible Promissory Note, net $ 4,724 $ (94) $ 149 $ (758) $ — $ — $ 4,021 Embedded Derivative $ 276 $ — $ — $ — $ — $ 686 $ 962 Interest Receivable $ — $ — $ — $ — $ 329 $ — $ 329 Total in Other Current Assets $ 5,000 $ (94) $ 149 $ (758) $ 329 $ 686 $ 5,312 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 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 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 | ReclassificationsCertain 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. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers cash and cash equivalents to be highly liquid investments with an original maturity of three months or less from the date of purchase. 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 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. The following tables present the Company’s hierarchy for its assets measured at fair value as of December 31, 2021 and 2020: December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Tyme 6,030 6,030 — — Total financial assets $ 68,370 $ 63,387 $ — $ 4,983 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 $ — $ — The Company recognizes 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 years ended December 31, 2021 and 2020, respectively. Our investment in the convertible promissory note and the embedded derivative are classified as Level 3. We analyzed and assessed 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 14, Convertible Promissory Note for further details. Our investment in restricted shares of common stock of Tyme Technologies, Inc. (“Tyme”) are classified as Level 1. Refer to Note 9, "License and Collaboration Agreements" for further details. |
Intangible Assets | Intangible Assets Finite-lived intangible assets are measured at their respective fair values on the date they were recorded at the date of subsequent adjustments of fair value and stated net of accumulated amortization. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. The Company amortizes its definite-lived intangible assets using either the straight-line or accelerated method, based on the useful life of the asset over which it is expected to be consumed utilizing expected undiscounted future cash flows. The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment significant changes in our forecasted projections for the asset or asset group for reasons including, but not limited to, significant under-performance of a product in relation to |
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 fair value of the reporting unit’s goodwill is less than it's carrying amount. The Company performed a qualitative annual test for goodwill as of October 1, 2021. During the year ended December 31, 2021, the Company concluded that |
Concentration of Major Customers and Vendors | Concentration of Major Customers and Vendors The Company is dependent on its commercial partner to market and sell Bendeka; therefore, the Company's future revenues are highly dependent on the collaboration and distribution arrangement with Teva. Teva markets Bendeka through a license agreement with the Company. Pursuant to that license agreement, Teva pays the Company a royalty based on net sales of the product and also purchases the product from the Company. A disruption in this arrangement, caused by, among other things, a supply disruption, loss of exclusivity or the launch of a superior product would have a material adverse effect of the Company’s financial position, results of operations and cash flows. |
Inventories | InventoriesInventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. The Company periodically reviews the composition of its inventories 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 inventories, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Depreciation is recorded over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. |
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. |
Advertising and Marketing | Advertising and MarketingAdvertising and marketing costs are expensed as incurred. |
Income Taxes | Income Taxes The Company accounts for income taxes using the liability method in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 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 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 the 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 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, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies 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, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue. Product revenue - The Company recognizes net revenue on sales to its commercial partners and to end users. In each instance, revenue is generally recognized when the customer obtains control of the Company’s 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. 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. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price generally utilizing the expected value method to which the Company expects to be entitled. As such, revenue on sales to end users 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 allowance for chargebacks and rebate reserves. The Company has a product returns policy on some of its 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. The Company's 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. The Company has terms on sales of Ryanodex by which the Company does not accept returns. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made generally using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company believes that the estimates it has 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 the Company's distributors. The Company's 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 the Company’s 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 : The Company contracts 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. The Company estimates the rebates it 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. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s 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 the Company’s distributors. The information that the Company also considers when establishing its 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. The Company regularly reviews and monitors estimated or actual customer inventory information at its largest distributors for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : The Company's provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. The Company’s 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. The Company estimates future product returns on sales of Belrapzo based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iii) historical industry information regarding return rates for similar pharmaceutical products, (iv) the estimated remaining shelf life of Belrapzo previously shipped and currently being shipped to distributors and (v) contractual agreements intended to limit the amount of inventory maintained by the Company’s 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 consolidated balance sheets. Wholesaler fees and other incentives : The Company generally provides invoice discounts on Belrapzo and Ryanodex sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. 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, the Company expects its distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. The Company recorded product sales, net as follows: Year Ended December 31, 2021 2020 2019 (in thousands) Bendeka $ 11,167 $ 15,439 $ 31,182 Belrapzo 23,728 27,527 29,665 Ryanodex 25,271 28,268 13,039 Other 4,857 1,089 103 Product sales, net $ 65,023 $ 72,323 $ 73,989 The following table provides a summary roll-forward of the Company's net product revenue allowances and related reserves for the years ended December 31, 2021 and 2020, on the consolidated balance sheets (in thousands): Chargebacks Commercial Rebates Medicaid Rebates Product Returns Wholesaler Fees and Other Incentives Total Balance at December 31, 2019 $ 2,988 $ 1,131 $ 567 $ 2,403 $ 2,011 $ 9,100 Provisions / Adjustments 20,368 1,243 484 (391) 8,526 30,230 Charges processed / Payments (21,067) (602) (367) (346) (5,146) (27,528) Balance at December 31, 2020 $ 2,289 $ 1,772 $ 684 $ 1,666 $ 5,391 $ 11,802 Provisions / Adjustments 27,402 3,042 268 2,531 9,650 42,893 Charges processed / Payments (25,852) (2,838) (332) (2,674) (13,070) (44,766) Balance at December 31, 2021 $ 3,839 $ 1,976 $ 620 $ 1,523 $ 1,971 $ 9,929 Such net product revenue allowances and reserves are included within accounts receivable, net and accrued expenses and other current liabilities within the consolidated balance sheets. Royalty Revenue — The Company recognizes revenue from license arrangements with its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 25 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. Our receivables from royalty revenue are due 45-days from the end of the quarter. License and other revenue — The Company analyzes each element of its 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. The Company recognizes 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. The Company determines 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, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes 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, the Company 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, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, the Company 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. |
Stock-Based Compensation | Stock-Based Compensation The Company utilize stock-based compensation in the form of stock options, restricted stock units ("RSUs") and performance-based stock units ("PSUs"), each of which may be granted separately or in tandem with other awards. Compensation expense is recognized in the Consolidated Statements of operations based on the estimated fair value of the awards at grant date ratably over the requisite service period, which generally equals the vesting period of the award. The grant-date fair value of stock awards is based upon the underlying price of the stock on the date of grant. The grant-date fair value of stock option awards must be determined using an option pricing model. The Company uses the Black-Scholes option pricing formula for determining the grant-date fair value of such awards. Option pricing models require the use of estimates and assumptions as to (a) the expected term of the option, (b) the expected volatility of the price of the underlying stock and (c) the risk-free interest rate for the expected term of the option. The Company may also grant performance-based stock awards to employees from time-to-time in form of market condition or performance condition. The grant-date fair value of awards that vest based on achievement of certain market condition are determined using a Monte Carlo simulation technique. The grant-date fair value of awards that vest based on achievement of certain performance condition are determined using the accelerated attribution method once it is probable that the performance condition will be achieved. |
Earnings Per Share | Earnings Per ShareBasic 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 options. 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, as calculated under the treasury method. |
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, or another reference rate expected to be discontinued due to reference rate reform. The new guidance provides optional expedients, including; (1) Simplify accounting analyses under current GAAP for contract modifications, such as modifications of contracts within the scope of Topic 470, Debt, that will be accounted for by prospectively adjusting the effective interest rate, as if any modification was not substantial. That is, the original contract and the new contract shall be accounted for as if they were not substantially different from one another; (2) Simplify the assessment of hedge effectiveness and allow hedging relationships affected by reference rate reform to continue; (3) Allow a one-time election to sell or transfer debt securities classified as held to maturity before January 1, 2020 that reference a rate affected by reference rate reform. The amendments are effective for all entities from the beginning of an interim period that includes the issuance date of the ASU. An entity may elect to apply the amendments prospectively through December 31, 2022. The adoption of ASU 2020-4 is not expected to have a material impact on the Company's financial position or results of operations. CARES Act On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed into U.S. federal law, which is aimed at providing emergency assistance and health care for individuals, families, and businesses affected by the |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Fair Value, by Balance Sheet Grouping | The following tables present the Company’s hierarchy for its assets measured at fair value as of December 31, 2021 and 2020: December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Tyme 6,030 6,030 — — Total financial assets $ 68,370 $ 63,387 $ — $ 4,983 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 Revenue by Major Customers by Reporting Segments | The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Year Ended December 31, 2021 2020 2019 Net revenues Cephalon, Inc. (Teva) - See Revenue Recognition 66 % 67 % 77 % Other 34 % 33 % 23 % 100 % 100 % 100 % December 31, 2021 2020 Accounts receivable Cephalon, Inc. (Teva) - See Revenue Recognition 63 % 58 % Other 37 % 42 % 100 % 100 % |
Revenue from External Customers by Products and Services | The Company recorded product sales, net as follows: Year Ended December 31, 2021 2020 2019 (in thousands) Bendeka $ 11,167 $ 15,439 $ 31,182 Belrapzo 23,728 27,527 29,665 Ryanodex 25,271 28,268 13,039 Other 4,857 1,089 103 Product sales, net $ 65,023 $ 72,323 $ 73,989 |
Summary of Sales Allowances and Related Accruals | The following table provides a summary roll-forward of the Company's net product revenue allowances and related reserves for the years ended December 31, 2021 and 2020, on the consolidated balance sheets (in thousands): Chargebacks Commercial Rebates Medicaid Rebates Product Returns Wholesaler Fees and Other Incentives Total Balance at December 31, 2019 $ 2,988 $ 1,131 $ 567 $ 2,403 $ 2,011 $ 9,100 Provisions / Adjustments 20,368 1,243 484 (391) 8,526 30,230 Charges processed / Payments (21,067) (602) (367) (346) (5,146) (27,528) Balance at December 31, 2020 $ 2,289 $ 1,772 $ 684 $ 1,666 $ 5,391 $ 11,802 Provisions / Adjustments 27,402 3,042 268 2,531 9,650 42,893 Charges processed / Payments (25,852) (2,838) (332) (2,674) (13,070) (44,766) Balance at December 31, 2021 $ 3,839 $ 1,976 $ 620 $ 1,523 $ 1,971 $ 9,929 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The anti-dilutive common shares equivalents outstanding at December 31, 2021, 2020, and 2019 were as follows: Year Ended December 31, 2021 2020 2019 Options 2,336,586 2,767,501 2,454,077 Restricted stock units 98,416 207,177 — Total 2,435,002 2,974,678 2,454,077 |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation for basic and diluted net (loss) income per share for December 31, 2021, 2020, and 2019: Year Ended December 31, 2021 2020 2019 Numerator Numerator for basic and diluted earnings per share-net (loss) income $ (8,627) 11,989 $ 14,313 Denominator Basic weighted average common shares outstanding 13,051,095 13,481,525 13,754,516 Dilutive effect of stock options — 289,868 384,217 Diluted weighted average common shares outstanding 13,051,095 13,771,393 14,138,733 Basic net (loss) income per share Basic net (loss) income per share $ (0.66) $ 0.89 $ 1.04 Diluted net (loss) income per share Diluted net (loss) income per share $ (0.66) $ 0.87 $ 1.01 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The Company's inventory balance consists of the following: December 31, 2021 2020 Raw materials $ 7,317 $ 3,515 Work-in-process 9,666 2,589 Finished goods 4,925 1,971 $ 21,908 $ 8,075 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consists of the following: December 31, Estimated Useful Life (years) 2021 2020 Furniture and fixtures $ 1,525 $ 1,476 7 Office equipment 1,077 1,152 3 Equipment 3,834 3,485 7 Leasehold improvements 1,155 1,155 2 7,591 7,268 Less accumulated depreciation (5,955) (5,191) Property and equipment, net $ 1,636 $ 2,077 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid and other current assets consist of the following: December 31, 2021 2020 Advances to commercial manufacturers $ 942 $ 660 Prepaid FDA user fee and advances to CROs 1,108 1,262 Prepaid insurance 196 191 Prepaid income taxes 1,173 — Convertible promissory note, net 5,312 — All other 3,159 1,605 Total Prepaid expenses and other current assets $ 11,890 $ 3,718 |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: December 31, 2021 2020 Royalties payable to commercial partners $ 5,085 $ 5,996 Accrued research & development 4,100 2,724 Accrued professional fees 2,013 2,370 Accrued salary and other compensation 8,466 4,686 Accrued product sales reserves 4,390 4,966 Current portion of lease liability 1,309 1,123 All other 6,975 1,952 Total Accrued expenses and other liabilities $ 32,338 $ 23,817 |
Schedule of Lease Related Disclosures | The table below summarizes the Company's total lease costs included in the consolidated financial statements, as well as other required quantitative disclosures (in thousands): As of December 31, July 13, 1905 July 12, 1905 Operating lease cost $ 1,407 $ 1,323 Total lease cost $ 1,407 $ 1,323 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 1,407 $ 1,323 Right-of-use assets obtained in exchange for new operating lease liabilities $ 270 $ 855 Weighted-average remaining lease term - operating leases 3.1 years 4.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % Year Ending December 31, Operating Leases 2022 1,423 2023 1,455 2024 1,038 2025 413 Thereafter — Total 4,329 Less: present value discount (116) Present value of lease liabilities $ 4,213 Balance Sheet Classification as of December 31, 2021 Current lease liabilities (included with Accrued expenses and other liabilities) $ 1,309 Long-term lease liabilities (included with Other long-term liabilities) 2,904 Total lease liabilities $ 4,213 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Long-term Debt | Debt Maturities As of December 31, 2021 2022 $ 26,000 Total $ 26,000 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Class of Treasury Stock | We repurchased the following shares of common stock with cash resources: Year Ended December 31, 2021 2020 2019 Shares of common stock repurchased 429,446 774,489 317,429 Cash paid for r epurchases of common stock $ 21,213 $ 34,999 $ 17,961 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, 2021 2020 2019 Risk-free interest rate 0.51% - 1.26% 0.37% - 1.65% 1.42% - 2.61% Volatility 52.87% - 60.02% 54.89% - 55.51% 40.83% Expected term (in years) 5.50 - 6.08 years 5.50 - 6.08 years 1.51 - 9.41 years Expected dividend yield 0.0% 0.0% 0.0% |
Share-based Compensation Arrangement by Share-based Payment Award | The following table summarizes information about stock option activity related to the 2014 Plan: Number of Weighted Non- Exercisable Outstanding at December 31, 2019 3,096,161 $ 59.29 1,070,054 2,026,107 Granted 762,200 $ 55.76 Exercised (149,473) $ 24.43 Forfeited or expired (376,998) $ 66.71 Outstanding at December 31, 2020 3,331,890 $ 59.20 1,028,142 2,303,748 Granted 114,000 $ 46.74 Exercised (122,847) $ 27.64 Forfeited or expired (508,165) $ 62.00 Outstanding at December 31, 2021 2,814,878 $ 58.51 472,916 2,341,962 |
Schedule of Restricted Stock Unit Activity | The following table summarizes information about RSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2019 251,215 $ 44.84 Granted 236,450 $ 59.48 Vested (79,420) $ 46.78 Forfeited (79,849) $ 52.76 Non-vested at December 31, 2020 328,396 $ 53.09 Granted 106,600 $ 48.55 Vested (95,523) $ 52.26 Forfeited (76,167) $ 52.29 Non-vested at December 31, 2021 263,306 $ 51.77 |
Schedule of Phantom Share Unit Activity | The following table summarizes information about PSU activity related to the 2014 Plan: Number of Weighted Non-vested at December 31, 2019 116,181 $ 90.19 Granted — $ — Vested — $ — Forfeited (18,431) $ 90.19 Non-vested at December 31, 2020 97,750 $ 90.19 Granted 159,000 $ 62.94 Vested — $ — Forfeited (119,450) $ 84.90 Non-vested at December 31, 2021 137,300 $ 63.24 |
Schedule of Share-based Compensation Cost | The Company recognized stock-based compensation in its consolidated statements of operations for the year ended December 31, 2021, 2020, and 2019 as follows: Year Ended December 31, 2021 2020 2019 Stock options $ 11,521 $ 17,694 $ 16,394 PSUs 2,729 1,635 3,062 RSUs 5,305 5,427 2,542 Stock-based compensation expense $ 19,555 $ 24,756 $ 21,998 Selling, general and administrative $ 16,873 $ 22,074 $ 17,556 Research and development 2,682 2,682 4,442 Stock-based compensation expense $ 19,555 $ 24,756 $ 21,998 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Provision | The components of our provision from income taxes is as follows: Year Ended December 31, 2021 2020 2019 Current: Federal $ 6,912 $ 10,140 $ 6,689 State 785 2,059 844 $ 7,697 $ 12,199 $ 7,533 Deferred: Federal (3,030) (1,227) 392 State (588) (284) (240) $ (3,618) $ (1,511) $ 152 Provision for income taxes $ 4,079 $ 10,688 $ 7,685 |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation of the statutory U.S. Federal income tax rate to the Company's effective income tax rate is as follows; Year Ended December 31, 2021 2020 2019 U.S. Federal statutory tax rate 21 % 21 % 21 % State income taxes, net of federal benefit (1) % 6 % 2 % Tax effect on stock option exercises, net of forfeitures (44) % 4 % 1 % R&D tax credits and Orphan Drug credits 31 % (2) % (2) % Limitation on executive compensation (60) % 9 % 10 % Change in valuation allowance (40) % 9 % 4 % Foreign rate differential 4 % (1) % (2) % Other (1) % 1 % 1 % Effective tax rate (90) % 47 % 35 % |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company's deferred tax assets were as follows: December 31, 2021 2020 Deferred tax assets Net operating loss carryforward $ 1,563 $ 841 Stock based compensation 10,405 12,015 Other asset - equity investment with readily determined fair value 3,190 1,771 Inventories 2,123 2,338 Employee-related expenses 1,240 51 Intangible assets 4,207 708 Right-of-use liability 962 1,154 R&D tax credit carryforwards 329 86 Other 1,489 1,216 Total deferred tax assets 25,508 20,180 Deferred tax liabilities Installment sale - Malta 485 483 Prepaid expenses 45 43 Fixed assets 300 315 Lease liability 921 1,092 Total deferred tax liabilities 1,751 1,933 Valuation allowance (4,959) (3,067) Net deferred tax assets $ 18,798 $ 15,180 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Commitments | Our future material contractual obligations include the following: Obligation Total 2022 2023 2024 2025 Operating leases (1) $ 4,329 $ 1,423 $ 1,455 $ 1,038 $ 413 Credit facility 26,000 26,000 — — — Purchase obligations (2) 69,549 69,549 — — — Total obligations $ 99,878 $ 96,972 $ 1,455 $ 1,038 $ 413 (1) We lease our corporate office location. On August 8, 2019, we amended the lease for our corporate office location in order to rent additional office space and extend the term of our existing lease to June 30, 2025. The Company also leases its lab space under a lease agreement that expires on April 30, 2024. We also lease office space located in Palm Beach Gardens, FL. The new lease agreement commenced on November 1, 2021 and will expire 36 months from the lease commencement date, which is October 31, 2024. Rental expense was $1,407, $1,323, and $1,146, for the years ended December 31, 2021, 2020, and 2019, respectively. The remaining future lease payments under the operating leases, exclusive of any renewal option periods, are $4,329 as of December 31, 2021, payable monthly. December 31, 2021 Total operating lease payments $ 4,329 Less: imputed interest (116) Total lease liabilities $ 4,213 (2) As of December 31, 2021, the Company has purchase obligations in the amount of $69,549 which represents the contractual commitments under contract manufacturing and supply agreements with suppliers. The obligation under the supply agreement is primarily for finished product, inventory, and research and development. |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | The gross carrying amounts and net book value of our intangible assets are as follows: December 31, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charges Net Book Value Ryanodex intangible 18.5 $ 15,000 $ (5,079) $ — $ 9,921 Developed technology 5 8,100 (8,100) — — Vasopressin Milestone 1 750 — — 750 Total $ 23,850 $ (13,179) $ — $ 10,671 December 31, 2020 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charge Net Book Value Ryanodex intangible 20 15,000 (3,500) — 11,500 Developed technology 5 8,100 (6,683) — 1,417 Total $ 23,100 $ (10,183) $ — $ 12,917 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | Based on definite-lived intangible assets recorded as of December 31, 2021, and assuming that the underlying assets will not be impaired and that the Company will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2022 3,073 2023 2,785 2024 2,511 2025 2,302 All other — Total estimated amortization expense $ 10,671 |
Convertible Promissory Note (Ta
Convertible Promissory Note (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Convertible Promissory Note Activity | The following table summarizes the amounts recorded and activity during the year ended December 31, 2021; Initial Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative December 31, 2021 Fair value of the note $ 5,000 $ (94) $ — $ — $ — $ — $ 4,906 Discount on the note (276) — 149 — — — (127) Estimated Credit Loss — — — (758) — — (758) Convertible Promissory Note, net $ 4,724 $ (94) $ 149 $ (758) $ — $ — $ 4,021 Embedded Derivative $ 276 $ — $ — $ — $ — $ 686 $ 962 Interest Receivable $ — $ — $ — $ — $ 329 $ — $ 329 Total in Other Current Assets $ 5,000 $ (94) $ 149 $ (758) $ 329 $ 686 $ 5,312 |
Organization and Business (Deta
Organization and Business (Details) $ in Thousands | Oct. 01, 2019 | Sep. 30, 2019 | Mar. 29, 2019USD ($) | Dec. 31, 2021 | Dec. 31, 2021USD ($)productsegmentshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2021USD ($)shares |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Number of products launched | product | 3 | |||||||
Number of reportable segments | segment | 1 | |||||||
Shares of common stock repurchased (in shares) | shares | 429,446 | 774,489 | 317,429 | |||||
Cash paid for repurchases of common stock | $ 21,213 | $ 34,999 | $ 17,961 | |||||
Cash paid for repurchases of common stock | $ 21,213 | $ 32,037 | $ 17,961 | |||||
Accelerated Share Repurchase | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares of common stock repurchased (in shares) | shares | 4,111,622 | |||||||
Cash paid for repurchases of common stock | $ 228,100 | |||||||
Vasopressin | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Marketing exclusivity term | 180 days | |||||||
Teva Pharmaceuticals | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Cash proceeds from license agreement | $ 9,000 | |||||||
Cephalon, Inc. | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Royalty payments if product is approved, percentage of net sales | 30.00% | 25.00% | ||||||
Royalty revenue, percent of net sales threshold | 32.00% |
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 | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Money market funds | $ 57,357 | $ 79,682 |
Convertible promissory note | 4,021 | |
Embedded derivative asset in convertible promissory note | 962 | |
Investment in Tyme | 6,030 | 12,200 |
Total financial assets | 68,370 | 91,882 |
Level 1 | ||
Assets: | ||
Money market funds | 57,357 | 79,682 |
Convertible promissory note | 0 | |
Embedded derivative asset in convertible promissory note | 0 | |
Investment in Tyme | 6,030 | 12,200 |
Total financial assets | 63,387 | 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 | |
Total financial assets | 0 | 0 |
Level 3 | ||
Assets: | ||
Money market funds | 0 | 0 |
Convertible promissory note | 4,021 | |
Embedded derivative asset in convertible promissory note | 962 | |
Investment in Tyme | 0 | |
Total financial assets | $ 4,983 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Major Customers as a Percentage (Details) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Net Revenues | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 100.00% | 100.00% | 100.00% |
Net Revenues | Cephalon, Inc. | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 66.00% | 67.00% | 77.00% |
Net Revenues | Other | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 34.00% | 33.00% | 23.00% |
Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 100.00% | 100.00% | |
Accounts Receivable | Cephalon, Inc. | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 63.00% | 58.00% | |
Accounts Receivable | Other | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 37.00% | 42.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Short-term Debt [Line Items] | |||
Goodwill impairment | $ 0 | $ 0 | $ 0 |
Advertising and marketing costs | $ 2,600,000 | $ 2,700,000 | $ 2,400,000 |
Bendeka | |||
Short-term Debt [Line Items] | |||
Reporting term for partners' net product sales, royalty revenue | 25 days |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Product Sales (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Product Information [Line Items] | |||
Total revenue | $ 171,546 | $ 187,802 | $ 195,892 |
Bendeka | |||
Product Information [Line Items] | |||
Total revenue | 11,167 | 15,439 | 31,182 |
Belrapzo | |||
Product Information [Line Items] | |||
Total revenue | 23,728 | 27,527 | 29,665 |
Ryanodex | |||
Product Information [Line Items] | |||
Total revenue | 25,271 | 28,268 | 13,039 |
Other | |||
Product Information [Line Items] | |||
Total revenue | 4,857 | 1,089 | 103 |
Product sales, net | |||
Product Information [Line Items] | |||
Total revenue | $ 65,023 | $ 72,323 | $ 73,989 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Sales Allowances and Related Accruals (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | $ 11,802 | $ 9,100 |
Provisions / Adjustments | 42,893 | 30,230 |
Charges processed / Payments | (44,766) | (27,528) |
Ending balance | 9,929 | 11,802 |
Chargebacks | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 2,289 | 2,988 |
Provisions / Adjustments | 27,402 | 20,368 |
Charges processed / Payments | (25,852) | (21,067) |
Ending balance | 3,839 | 2,289 |
Commercial Rebates | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 1,772 | 1,131 |
Provisions / Adjustments | 3,042 | 1,243 |
Charges processed / Payments | (2,838) | (602) |
Ending balance | 1,976 | 1,772 |
Medicaid Rebates | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 684 | 567 |
Provisions / Adjustments | 268 | 484 |
Charges processed / Payments | (332) | (367) |
Ending balance | 620 | 684 |
Product Returns | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 1,666 | 2,403 |
Provisions / Adjustments | 2,531 | (391) |
Charges processed / Payments | (2,674) | (346) |
Ending balance | 1,523 | 1,666 |
Wholesaler Fees and Other Incentives | ||
Sales Revenue, Deductions [Roll Forward] | ||
Beginning balance | 5,391 | 2,011 |
Provisions / Adjustments | 9,650 | 8,526 |
Charges processed / Payments | (13,070) | (5,146) |
Ending balance | $ 1,971 | $ 5,391 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,435,002 | 2,974,678 | 2,454,077 |
Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,336,586 | 2,767,501 | 2,454,077 |
Restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 98,416 | 207,177 | 0 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator | |||
Numerator for basic earnings per share-net income | $ (8,627) | $ 11,989 | $ 14,313 |
Numerator for diluted earnings per share-net income | $ (8,627) | $ 11,989 | $ 14,313 |
Denominator | |||
Basic weighted average common shares outstanding (in shares) | 13,051,095 | 13,481,525 | 13,754,516 |
Dilutive effect of stock options (in shares) | 0 | 289,868 | 384,217 |
Diluted weighted average common shares outstanding (in shares) | 13,051,095 | 13,771,393 | 14,138,733 |
Basic net (loss) income per share | |||
Basic (in dollars per share) | $ (0.66) | $ 0.89 | $ 1.04 |
Diluted net (loss) income per share | |||
Diluted (in dollars per share) | $ (0.66) | $ 0.87 | $ 1.01 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 7,317 | $ 3,515 |
Work-in-process | 9,666 | 2,589 |
Finished goods | 4,925 | 1,971 |
Inventories | $ 21,908 | $ 8,075 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 7,591 | $ 7,268 |
Less accumulated depreciation | (5,955) | (5,191) |
Property and equipment, net | 1,636 | 2,077 |
Depreciation expense | 764 | 872 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,525 | 1,476 |
Estimated Useful Life (years) | 7 years | |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,077 | 1,152 |
Estimated Useful Life (years) | 3 years | |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 3,834 | 3,485 |
Estimated Useful Life (years) | 7 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,155 | $ 1,155 |
Estimated Useful Life (years) | 2 years |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Advances to commercial manufacturers | $ 942 | $ 660 |
Prepaid FDA user fee and advances to CROs | 1,108 | 1,262 |
Prepaid insurance | 196 | 191 |
Prepaid income taxes | 1,173 | 0 |
Convertible promissory note, net | 5,312 | 0 |
All other | 3,159 | 1,605 |
Total Prepaid expenses and other current assets | $ 11,890 | $ 3,718 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Royalties payable to commercial partners | $ 5,085 | $ 5,996 |
Accrued research & development | 4,100 | 2,724 |
Accrued professional fees | 2,013 | 2,370 |
Accrued salary and other compensation | 8,466 | 4,686 |
Accrued product sales reserves | $ 4,390 | $ 4,966 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total Accrued expenses and other liabilities | Total Accrued expenses and other liabilities |
Current portion of lease liability | $ 1,309 | $ 1,123 |
All other | 6,975 | 1,952 |
Total Accrued expenses and other liabilities | $ 32,338 | $ 23,817 |
Balance Sheet Accounts - Narrat
Balance Sheet Accounts - Narrative (Details) | Dec. 31, 2021 | Nov. 01, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Lessee, operating lease, term of contract | 36 months | |
Lessee, operating lease, remaining lease term | 3 years 1 month 6 days | |
Lessee, operating lease, renewal term (up to) | 5 years |
Balance Sheet Accounts - Lease
Balance Sheet Accounts - Lease Related Disclosures (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |||
Operating lease cost | $ 1,407 | $ 1,323 | $ 1,146 |
Total lease cost | 1,407 | 1,323 | |
Cash paid for amounts included in the measurement of lease liabilities | |||
Operating cash flows for operating leases | 1,407 | 1,323 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 270 | $ 855 | $ 3,716 |
Weighted-average remaining lease term - operating leases | 3 years 1 month 6 days | 4 years 1 month 6 days | |
Weighted-average discount rate - operating leases | 6.00% | 6.00% | |
Operating Leases | |||
2022 | $ 1,423 | ||
2023 | 1,455 | ||
2024 | 1,038 | ||
2025 | 413 | ||
Thereafter | 0 | ||
Total | 4,329 | ||
Less: imputed interest | (116) | ||
Present value of lease liabilities | $ 4,213 | ||
Balance Sheet Classification as of December 31, 2021 | |||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | Accrued Liabilities, Current | |
Current lease liabilities (included with Accrued expenses and other liabilities) | $ 1,309 | $ 1,123 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | ||
Long-term lease liabilities (included with Other long-term liabilities) | $ 2,904 | ||
Total lease liabilities | $ 4,213 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | Nov. 08, 2019 | Dec. 31, 2021 | Dec. 31, 2020 |
Short-term Debt [Line Items] | |||
Short-term debt | $ 25,607,000 | $ 8,000,000 | |
Unamortized debt issuance expense | $ 400,000 | ||
Line of Credit | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Proceeds from line of credit | $ 40,000,000 | ||
Revolving Credit Facility | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Line of credit facility, maximum borrowing capacity | $ 110,000,000 | ||
London Interbank Offered Rate (LIBOR) | Second Amended and Restated Credit Agreement | |||
Short-term Debt [Line Items] | |||
Interest rate margin | 1.00% | ||
New York Federal Reserve Bank (NYFRB) | Second Amended and Restated Credit Agreement | |||
Short-term Debt [Line Items] | |||
Interest rate margin | 0.50% | ||
Minimum | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Commitment fee percentage | 0.35% | ||
Minimum | London Interbank Offered Rate (LIBOR) | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Interest rate margin | 2.25% | ||
Minimum | Prime Rate | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Interest rate margin | 1.25% | ||
Maximum | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Commitment fee percentage | 0.45% | ||
Maximum | London Interbank Offered Rate (LIBOR) | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Interest rate margin | 3.00% | ||
Maximum | Prime Rate | Amendment Credit Agreement | |||
Short-term Debt [Line Items] | |||
Interest rate margin | 2.00% |
Debt - Schedule of Debt Maturit
Debt - Schedule of Debt Maturities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 26,000 |
Total | $ 26,000 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Narrative (Details) | Sep. 24, 2020USD ($)$ / sharesshares | Aug. 04, 2015shares | Mar. 31, 2021milestone$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Mar. 17, 2020USD ($) | Dec. 31, 2021USD ($)shares | Sep. 23, 2020USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Repurchases of common stock | $ 21,213,000 | $ 34,999,000 | $ 17,961,000 | ||||||
Fair value adjustments on settled accelerated share repurchase agreement | $ 0 | $ 2,962,000 | $ 0 | ||||||
Shares of common stock repurchased (in shares) | shares | 429,446 | 774,489 | 317,429 | ||||||
Share-based payment award, award vesting period | 4 years | ||||||||
Number of shares available for grant (in shares) | shares | 1,934,193 | 1,934,193 | |||||||
Weighted-average grant-date fair value of options granted (in dollars per share) | $ / shares | $ 23.62 | $ 28.98 | $ 22.18 | ||||||
Unrecognized compensation cost | $ 8,853,000 | $ 8,853,000 | |||||||
Total intrinsic value of options exercised | $ 2,434,000 | ||||||||
Weighted average contractual terms of options outstanding | 5 years 2 months 12 days | 6 years 1 month 6 days | 6 years 9 months 18 days | ||||||
Aggregate pre-tax intrinsic value of options outstanding | $ 13,800,000 | $ 11,600,000 | $ 31,900,000 | 13,800,000 | |||||
Common stock | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based payment award, number of additional shares authorized (in shares) | shares | 500,000 | ||||||||
Options | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Unrecognized compensation cost expense term | 2 years | ||||||||
Expected volatility | 40.83% | ||||||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | ||||||
Options | Minimum | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 1 year 6 months 3 days | ||||||
Options | Maximum | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 9 years 4 months 28 days | ||||||
RSU | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Unrecognized compensation cost expense term | 2 years 3 months 18 days | ||||||||
Unrecognized compensation cost | $ 7,562,000 | 7,562,000 | |||||||
Expired (in shares) | shares | 76,167 | 79,849 | |||||||
Granted (in shares) | shares | 106,600 | 236,450 | |||||||
Granted (in dollars per share) | $ / shares | $ 48.55 | $ 59.48 | |||||||
PSU | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Expired (in shares) | shares | 97,750 | 119,450 | 18,431 | ||||||
Granted (in shares) | shares | 159,000 | 0 | |||||||
Granted (in dollars per share) | $ / shares | $ 62.94 | $ 0 | |||||||
Risk free interest rate | 0.18% | ||||||||
Expected volatility | 44.00% | ||||||||
Expected term (in years) | 3 years | ||||||||
Expected dividend yield | 0.00% | ||||||||
PSU | S&P Biotechnology | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Granted (in shares) | shares | 99,500,000 | ||||||||
Granted (in dollars per share) | $ / shares | $ 71.09 | ||||||||
Milestone Performance-Based Stock Units | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Granted (in shares) | shares | 59,500 | ||||||||
Granted (in dollars per share) | $ / shares | $ 49.32 | ||||||||
Number of milestones | milestone | 1 | ||||||||
Number of milestones required to be met | milestone | 3 | ||||||||
Expiration period | 3 years | ||||||||
Expected achievement rate | 0.00% | ||||||||
Milestone Performance-Based Stock Units | Minimum | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Award vesting percentage of target number granted | 0.00% | ||||||||
Milestone Performance-Based Stock Units | Maximum | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Award vesting percentage of target number granted | 200.00% | ||||||||
March 2020 Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock repurchase program, authorized amount (up to) | $ 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 on settled accelerated share repurchase agreement | $ 3,000,000 | ||||||||
October 2018 Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Repurchases of common stock | $ 68,000,000 | ||||||||
Accelerated Share Repurchase | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Repurchases of common stock | $ 228,100,000 | ||||||||
Shares of common stock repurchased (in shares) | shares | 4,111,622 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Schedule of Common Stock Repurchase (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |||
Shares of common stock repurchased (in shares) | 429,446 | 774,489 | 317,429 |
Cash paid for repurchases of common stock | $ 21,213 | $ 34,999 | $ 17,961 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Compensation - Fair Value of Share Options Granted (Details) - Options | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 0.51% | 0.37% | 1.42% |
Risk-free interest rate, maximum | 1.26% | 1.65% | 2.61% |
Volatility, minimum | 52.87% | 54.89% | |
Volatility | 40.83% | ||
Volatility, maximum | 60.02% | 55.51% | |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 1 year 6 months 3 days |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 9 years 4 months 28 days |
Common Stock and Stock-Based _6
Common Stock and Stock-Based Compensation - Share-based Compensation, Options (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Beginning balance (in shares) | 3,331,890 | 3,096,161 | |
Granted (in shares) | 114,000 | 762,200 | |
Exercised (in shares) | (122,847) | (149,473) | |
Forfeited or expired (in shares) | (508,165) | (376,998) | |
Ending balance (in shares) | 2,814,878 | 3,331,890 | 3,096,161 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | |||
Beginning balance (in dollars per share) | $ 59.20 | $ 59.29 | |
Granted (in dollars per share) | 46.74 | 55.76 | |
Exercised (in dollars per share) | 27.64 | 24.43 | |
Forfeited or expired (in dollars per share) | 62 | 66.71 | |
Ending balance (in dollars per share) | $ 58.51 | $ 59.20 | $ 59.29 |
Non- Exercisable options outstanding (in shares) | 472,916 | 1,028,142 | 1,070,054 |
Exercisable options outstanding (in shares) | 2,341,962 | 2,303,748 | 2,026,107 |
Common Stock and Stock-Based _7
Common Stock and Stock-Based Compensation - Schedule of Restricted and Phantom Stock Unit Activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
RSU | |||
Number of Restricted Stock Units | |||
Beginning balance (in shares) | 328,396 | 328,396 | 251,215 |
Granted (in shares) | 106,600 | 236,450 | |
Vested (in shares) | (95,523) | (79,420) | |
Forfeited (in shares) | (76,167) | (79,849) | |
Ending balance (in shares) | 263,306 | 328,396 | |
Weighted Average Grant Date Fair Value (Per Share) | |||
Beginning balance (in dollars per share) | $ 53.09 | $ 53.09 | $ 44.84 |
Granted (in dollars per share) | 48.55 | 59.48 | |
Vested (in dollars per share) | 52.26 | 46.78 | |
Forfeited (in dollars per share) | 52.29 | 52.76 | |
Ending balance (in dollars per share) | $ 51.77 | $ 53.09 | |
PSU | |||
Number of Restricted Stock Units | |||
Beginning balance (in shares) | 97,750 | 97,750 | 116,181 |
Granted (in shares) | 159,000 | 0 | |
Vested (in shares) | 0 | 0 | |
Forfeited (in shares) | (97,750) | (119,450) | (18,431) |
Ending balance (in shares) | 137,300 | 97,750 | |
Weighted Average Grant Date Fair Value (Per Share) | |||
Beginning balance (in dollars per share) | $ 90.19 | $ 90.19 | $ 90.19 |
Granted (in dollars per share) | 62.94 | 0 | |
Vested (in dollars per share) | 0 | 0 | |
Forfeited (in dollars per share) | 84.90 | 90.19 | |
Ending balance (in dollars per share) | $ 63.24 | $ 90.19 |
Common Stock and Stock-Based _8
Common Stock and Stock-Based Compensation - Schedule of Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 19,555 | $ 24,756 | $ 21,998 |
Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 11,521 | 17,694 | 16,394 |
PSU | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 2,729 | 1,635 | 3,062 |
RSU | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 5,305 | 5,427 | 2,542 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 16,873 | 22,074 | 17,556 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 2,682 | $ 2,682 | $ 4,442 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
Federal | $ 6,912 | $ 10,140 | $ 6,689 |
State | 785 | 2,059 | 844 |
Total | 7,697 | 12,199 | 7,533 |
Deferred: | |||
Federal | (3,030) | (1,227) | 392 |
State | (588) | (284) | (240) |
Total | (3,618) | (1,511) | 152 |
Provision for income taxes | $ 4,079 | $ 10,688 | $ 7,685 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
U.S. Federal statutory tax rate | 21.00% | 21.00% | 21.00% |
State income taxes, net of federal benefit | (1.00%) | 6.00% | 2.00% |
Tax effect on stock option exercises, net of forfeitures | (44.00%) | 4.00% | 1.00% |
R&D tax credits and Orphan Drug credits | 31.00% | (2.00%) | (2.00%) |
Limitation on executive compensation | (60.00%) | 9.00% | 10.00% |
Change in valuation allowance | (40.00%) | 9.00% | 4.00% |
Foreign rate differential | 4.00% | (1.00%) | (2.00%) |
Other | (1.00%) | 1.00% | 1.00% |
Effective tax rate | (90.00%) | 47.00% | 35.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets | ||
Net operating loss carryforward | $ 1,563 | $ 841 |
Stock based compensation | 10,405 | 12,015 |
Other asset - equity investment with readily determined fair value | 3,190 | 1,771 |
Inventories | 2,123 | 2,338 |
Employee-related expenses | 1,240 | 51 |
Intangible assets | 4,207 | 708 |
Right-of-use liability | 962 | 1,154 |
R&D tax credit carryforwards | 329 | 86 |
Other | 1,489 | 1,216 |
Total deferred tax assets | 25,508 | 20,180 |
Deferred tax liabilities | ||
Installment sale - Malta | 485 | 483 |
Prepaid expenses | 45 | 43 |
Fixed assets | 300 | 315 |
Lease liability | 921 | 1,092 |
Total deferred tax liabilities | 1,751 | 1,933 |
Valuation allowance | (4,959) | (3,067) |
Net deferred tax assets | $ 18,798 | $ 15,180 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) $ in Millions | Dec. 31, 2021USD ($) |
Income Tax Disclosure [Abstract] | |
Deferred tax assets, operating loss carryforwards, foreign | $ 4.5 |
License and Collaboration Agr_2
License and Collaboration Agreements - License Agreements (Details) - Collaborative Arrangement, Transaction with Party to Collaborative Arrangement $ in Millions | Aug. 31, 2021USD ($) |
Combioxin | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Upfront payment | $ 10 |
Maximum aggregate milestone payments | 105 |
AOP Orphan Pharmaceuticals GmbH | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Upfront payment | 5 |
Maximum aggregate milestone payments | $ 25 |
License and Collaboration Agr_3
License and Collaboration Agreements - Collaboration with Tyme (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 07, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Gain (loss) on fair value adjustments | $ (6,170,000) | $ (5,300,000) | $ 0 | |
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Tyme | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Co-promotion agreement, percentage of promotional sales effort responsible for | 25.00% | |||
Co-promotion agreement, percentage of net revenue receivable | 15.00% | |||
Co-promotion agreement, percentage of net revenue receivable due to collaborator | 85.00% | |||
Co-promotion agreement, right to repurchase, amount | $ 200,000,000 | |||
Gain (loss) on fair value adjustments | $ (6,200,000) | $ 5,300,000 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Nov. 01, 2021 | |
Operating Leases | ||||
Total | $ 4,329 | |||
2022 | 1,423 | |||
2023 | 1,455 | |||
2024 | 1,038 | |||
2025 | 413 | |||
Less: imputed interest | (116) | |||
Total lease liabilities | 4,213 | |||
Credit facility | ||||
Total | 26,000 | |||
2022 | 26,000 | |||
2023 | 0 | |||
2024 | 0 | |||
2025 | 0 | |||
Purchase obligations | ||||
Total | 69,549 | |||
2022 | 69,549 | |||
2023 | 0 | |||
2024 | 0 | |||
2025 | 0 | |||
Total obligations | ||||
Total | 99,878 | |||
2022 | 96,972 | |||
2023 | 1,455 | |||
2024 | 1,038 | |||
2025 | 413 | |||
Lessee, operating lease, term of contract | 36 months | |||
Operating lease rent expense | $ 1,407 | $ 1,323 | $ 1,146 |
Related Party Transaction (Deta
Related Party Transaction (Details) - $ / shares | May 10, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Related Party Transaction [Line Items] | ||||
Shares of common stock repurchased (in shares) | 429,446 | 774,489 | 317,429 | |
Director | ||||
Related Party Transaction [Line Items] | ||||
Shares of common stock repurchased (in shares) | 100,000 | |||
Block trade closing price (in dollars per share) | $ 56.14 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 23,850 | $ 23,100 |
Accumulated Amortization | (13,179) | (10,183) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 10,671 | $ 12,917 |
Ryanodex intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 18 years 6 months | 20 years |
Gross Carrying Amount | $ 15,000 | $ 15,000 |
Accumulated Amortization | (5,079) | (3,500) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 9,921 | $ 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 |
Accumulated Amortization | (8,100) | (6,683) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 0 | $ 1,417 |
Vasopressin Milestone | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 1 year | |
Gross Carrying Amount | $ 750 | |
Accumulated Amortization | 0 | |
Accumulated Impairment Charges | 0 | |
Net Book Value | $ 750 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Change in Accounting Estimate [Line Items] | |||
Amortization expense of intangible assets | $ 2,996 | $ 2,666 | $ 2,520 |
Intangible assets | 10,671 | 12,917 | |
Ryanodex intangible | |||
Change in Accounting Estimate [Line Items] | |||
Intangible assets | 9,921 | $ 11,500 | |
Intangible Assets, Amortization Period | |||
Change in Accounting Estimate [Line Items] | |||
Amortization expense of intangible assets | $ 400 |
Intangible Assets, Net - Sche_2
Intangible Assets, Net - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2022 | $ 3,073 | |
2023 | 2,785 | |
2024 | 2,511 | |
2025 | 2,302 | |
All other | 0 | |
Net Book Value | $ 10,671 | $ 12,917 |
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 |
Convertible Promissory Note (De
Convertible Promissory Note (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | ||||
Total in Other Current Assets, beginning balance | $ 0 | $ 0 | ||
Fair Value Adjustments to the note | (94,000) | $ 0 | $ 0 | |
Estimated Credit Loss | (758,000) | 0 | $ 0 | |
Embedded Derivative, ending balance | 962,000 | |||
Total in Other Current Assets, ending balance | 5,312,000 | 0 | ||
Convertible Promissory Note | ||||
Debt Securities, Available-for-sale [Line Items] | ||||
Debt securities, available-for-sale | $ 5,000,000 | |||
Stated interest rate | 8.00% | |||
Credit agreement, term | 18 months | |||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | ||||
Fair value of the note, beginning balance | $ 5,000,000 | 5,000,000 | ||
Discount on the note, beginning balance | (276,000) | (276,000) | ||
Estimated Credit Loss, beginning balance | 0 | 0 | ||
Convertible Promissory Note, net, beginning balance | 4,724,000 | 4,724,000 | ||
Embedded Derivative, beginning balance | 276,000 | 276,000 | ||
Interest Receivable, beginning balance | 0 | 0 | ||
Total in Other Current Assets, beginning balance | $ 5,000,000 | 5,000,000 | ||
Fair Value Adjustments to the note | (94,000) | |||
Accretion of Discount | 149,000 | |||
Estimated Credit Loss | (758,000) | |||
Interest Income | 329,000 | |||
Fair Value Adjustment to Embedded Derivative | 686,000 | |||
Fair value of the note, ending balance | 4,906,000 | 5,000,000 | ||
Discount on the note, ending balance | (127,000) | (276,000) | ||
Estimated Credit Loss, ending balance | (758,000) | 0 | ||
Convertible Promissory Note, net, ending balance | 4,021,000 | 4,724,000 | ||
Embedded Derivative, ending balance | 962,000 | 276,000 | ||
Interest Receivable, ending balance | 329,000 | 0 | ||
Total in Other Current Assets, ending balance | $ 5,312,000 | $ 5,000,000 |