Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 24, 2020 | Jun. 30, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Transition Report | false | ||
Entity File Number | 001-36306 | ||
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 | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 677,440,631 | ||
Entity Common Stock, Shares Outstanding | 13,679,350 | ||
Documents Incorporated by Reference | Portions of the definitive proxy statement for our 2020 annual meeting of stockholders, which is to be filed within 120 days after the end of the fiscal year ended December 31, 2019, are incorporated by reference into Part III of this Form 10-K, to the extent described in Part III. | ||
Entity Central Index Key | 0000827871 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 109,775 | $ 78,791 |
Accounts receivable, net | 48,004 | 66,486 |
Inventories | 6,566 | 8,304 |
Prepaid expenses and other current assets | 15,104 | 10,263 |
Total current assets | 179,449 | 163,844 |
Property and equipment, net | 2,202 | 2,397 |
Intangible assets, net | 15,583 | 18,103 |
Goodwill | 39,743 | 39,743 |
Deferred tax asset, net | 13,669 | 13,822 |
Other assets | 3,908 | 694 |
Total assets | 254,554 | 238,603 |
Current liabilities: | ||
Accounts payable | 5,462 | 9,917 |
Accrued expenses and other liabilities | 28,361 | 23,519 |
Current portion of long-term debt | 5,000 | 6,250 |
Total current liabilities | 38,823 | 39,686 |
Other long-term liabilities | 3,000 | 0 |
Long-term debt, less current portion | 33,557 | 38,155 |
Total liabilities | 75,380 | 77,841 |
Stockholders' equity: | ||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of December 31, 2019 and 2018 | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 16,537,846 and 16,504,283 shares issued as of December 31, 2019 and 2018, respectively | 17 | 17 |
Additional paid in capital | 278,518 | 256,458 |
Retained earnings | 72,500 | 58,187 |
Treasury stock, at cost, 2,907,687 and 2,590,258 shares as of December 31, 2019 and 2018, respectively | (171,861) | (153,900) |
Total stockholders' equity | 179,174 | 160,762 |
Total liabilities and stockholders' equity | $ 254,554 | $ 238,603 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
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 (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) | 16,537,846 | 16,504,283 |
Treasury stock, shares (in shares) | 2,907,687 | 2,590,258 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | |||
Total revenue | $ 195,892 | $ 213,312 | $ 236,707 |
Operating expenses: | |||
Cost of product sales | 47,891 | 42,374 | 33,714 |
Cost of royalty revenue | 13,006 | 19,542 | 23,472 |
Research and development | 36,810 | 44,419 | 32,607 |
Selling, general and administrative | 76,370 | 60,509 | 71,416 |
Restructuring charge | 0 | 7,911 | 0 |
Asset impairment charge | 0 | 2,704 | 7,235 |
Change in fair value of contingent consideration | 0 | (763) | (7,377) |
Legal settlement | 0 | 0 | 1,650 |
Total operating expenses | 174,077 | 176,696 | 162,717 |
Income from operations | 21,815 | 36,616 | 73,990 |
Interest income | 2,169 | 158 | 91 |
Interest expense | (2,686) | (2,736) | (1,136) |
Other income | 700 | 0 | 0 |
Total other income (expense), net | 183 | (2,578) | (1,045) |
Income before income tax | 21,998 | 34,038 | 72,945 |
Income tax provision | 7,685 | 2,135 | 21,002 |
Net income | 14,313 | 31,903 | |
Net income | $ 14,313 | $ 31,903 | $ 51,943 |
Earnings per share: | |||
Basic (in dollars per share) | $ 1.04 | $ 2.16 | $ 3.44 |
Diluted (in dollars per share) | $ 1.01 | $ 2.09 | $ 3.27 |
Weighted average number of common shares outstanding: | |||
Basic (in shares) | 13,754,516 | 14,768,625 | 15,102,890 |
Diluted (in shares) | 14,138,733 | 15,278,651 | 15,908,211 |
Product sales | |||
Revenue: | |||
Total revenue | $ 73,989 | $ 70,385 | $ 45,327 |
Royalty revenue | |||
Revenue: | |||
Total revenue | 112,903 | 142,927 | 153,880 |
License and other revenue | |||
Revenue: | |||
Total revenue | $ 9,000 | $ 0 | $ 37,500 |
Consolidated statements of chan
Consolidated statements of changes in stockholders' equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Treasury Stock | (Accumulated Deficit) Retained Earnings |
Number of shares outstanding, beginning balance (in shares) at Dec. 31, 2016 | 15,891,000 | ||||
Stockholders' equity attributable to parent, beginning balance at Dec. 31, 2016 | $ 151,226 | $ 16 | $ 213,872 | $ (37,003) | $ (25,659) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | (15,429) | (15,429) | |||
Issuance of common stock upon exercise of stock option grants (in shares) | 198,000 | ||||
Proceeds from Stock Options Exercised | 4,338 | ||||
Issuance of common stock upon exercise of stock option grants | 4,338 | 4,338 | |||
Payment, Tax Withholding, Share-based Payment Arrangement | 0 | ||||
Payments for Repurchase of Common Stock | 43,792 | ||||
Common stock repurchases | (43,792) | (43,792) | |||
Net income | 51,943 | 51,943 | |||
Number of shares outstanding, ending balance (in shares) at Dec. 31, 2017 | 16,089,000 | ||||
Stockholders' equity attributable to parent, ending balance at Dec. 31, 2017 | 179,144 | $ 16 | 233,639 | (80,795) | 26,284 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | $ (19,082) | (19,082) | |||
Issuance of common stock upon exercise of stock option grants (in shares) | 502,322 | 415,000 | |||
Proceeds from Stock Options Exercised | $ 8,615 | ||||
Issuance of common stock upon exercise of stock option grants | 8,615 | $ 1 | 8,614 | ||
Payment, Tax Withholding, Share-based Payment Arrangement | 0 | ||||
Payments for Repurchase of Common Stock | 73,105 | ||||
Payments for employee net option exercises | (4,877) | (4,877) | |||
Common stock repurchases | (73,105) | (73,105) | |||
Net income | 31,903 | 31,903 | |||
Number of shares outstanding, ending balance (in shares) at Dec. 31, 2018 | 16,504,000 | ||||
Stockholders' equity attributable to parent, ending 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 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 23,032 | 34,000 | |||
Proceeds from Stock Options Exercised | $ 260 | ||||
Issuance of common stock upon exercise of stock option grants | 260 | ||||
Payment, Tax Withholding, Share-based Payment Arrangement | 198 | ||||
Share-based Payment Arrangement, Decrease for Tax Withholding Obligation | (198) | ||||
Payments for Repurchase of Common Stock | 17,961 | ||||
Common stock repurchases | (17,961) | ||||
Net income | 14,313 | 14,313 | |||
Number of shares outstanding, ending balance (in shares) at Dec. 31, 2019 | 16,538,000 | ||||
Stockholders' equity attributable to parent, ending balance at Dec. 31, 2019 | $ 179,174 | $ 17 | $ 278,518 | $ (171,861) | $ 72,500 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net income | $ 14,313 | $ 31,903 | $ 51,943 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Deferred income taxes | 152 | (2,468) | 17,289 |
Depreciation expense | 2,131 | 1,155 | 932 |
Amortization expense | 2,520 | 2,515 | 2,815 |
Stock-based compensation expense | 21,998 | 19,082 | 15,429 |
Change in fair value of contingent consideration | 0 | (763) | (7,377) |
Amortization of debt issuance costs | 480 | 376 | 222 |
Asset impairment charge | 0 | 2,704 | 7,235 |
Non-cash restructuring charge | 0 | 5,769 | 0 |
Changes in operating assets and liabilities which provided (used) cash: | |||
Accounts receivable | 18,481 | (12,665) | (11,627) |
Inventories | 1,739 | (5,556) | (2,379) |
Prepaid expenses and other current assets | (4,841) | 4,838 | 1,993 |
Other assets | (599) | (570) | 0 |
Accounts payable | (4,455) | (2,064) | (8,460) |
Accrued expenses and other liabilities | 4,067 | 8,128 | (9,096) |
Net cash provided by operating activities | 55,986 | 52,384 | 58,919 |
Cash flows from investing activities: | |||
Purchase of property and equipment | (777) | (133) | (4,436) |
Payment for Ryanodex intangible asset | 0 | 0 | (750) |
Net cash used in investing activities | (777) | (133) | (5,186) |
Cash flows from financing activities: | |||
Repurchases of common stock | (17,961) | (73,105) | (43,792) |
Payment of contingent consideration | 0 | (15,000) | 0 |
Proceeds from long-term debt | 0 | 0 | 50,000 |
Payment of debt | (6,000) | (3,750) | (1,250) |
Payment of debt financing costs | (326) | 0 | (1,192) |
Payment of employee withholding tax upon vesting of stock-based awards | (198) | 0 | 0 |
Payments for employee net option exercises | 0 | (4,877) | 0 |
Proceeds from common stock option exercises | 260 | 8,615 | 4,338 |
Net cash (used in) provided by financing activities | (24,225) | (88,117) | 8,104 |
Net increase (decrease) in cash and cash equivalents | 30,984 | (35,866) | 61,837 |
Cash and cash equivalents at beginning of period | 78,791 | 114,657 | 52,820 |
Cash and cash equivalents at end of period | 109,775 | 78,791 | 114,657 |
Cash paid during the period for: | |||
Income taxes, net | 6,673 | 2,281 | 10,542 |
Interest | 2,478 | 2,084 | 651 |
Right-of-use asset obtained in exchange for lease obligation - lease amendment | $ 3,716 | $ 0 | $ 0 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | Organization and Business Eagle Pharmaceuticals, Inc. (the "Company" or "we") is a specialty pharmaceutical company primarily focused on developing and commercializing injectable products, primarily in the Central Nervous System ("CNS") critical care and oncology areas, using the U.S. Food and Drug Administration's ("FDA's") 505(b)(2) New Drug Application ("NDA") regulatory pathway. The Company's business model is to develop proprietary innovations to FDA-approved injectable drugs, referred to as branded reference drugs, that offer favorable attributes to patients and healthcare providers. The Company has two products currently being sold in the United States under various license agreements in place with commercial partners; a ready-to-use formulation of Argatroban and rapidly infused bendamustine RTD 50ml solution (“Bendeka”). In addition, the Company directly sells two products in the United States; Eagle's bendamustine RTD 500ml solution (“Belrapzo") and Ryanodex ® (dantrolene sodium) ("Ryanodex"). The Company has a number of products currently under development and certain products may be subject to license agreements. We view our operation and manage our business as one reporting segment since the majority of our revenues are from royalties. On February 13, 2015, the Company submitted a NDA to the FDA for Bendeka, which was approved by the FDA on December 7, 2015. Also, on February 13, 2015, the Company entered into an Exclusive License Agreement (the “Cephalon License”) with Cephalon, Inc. (“Cephalon”), a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. (“Teva”), for U.S. and Canadian rights to Bendeka for treatment of patients with chronic lymphocytic leukemia (“CLL”) and patients with non-Hodgkin’s lymphoma (“NHL”). Subsequently, with the consent of the Company, Cephalon assigned to Teva Pharmaceuticals International GmbH (“TPIG”) all of Cephalon’s rights and obligations under the Cephalon License. Accordingly, all references to “Cephalon” or to the “Cephalon License” and the related supply agreements for Bendeka should be read and construed as references to TPIG and to the license agreement and supply agreements for Bendeka to which the Company and TPIG are now parties. Pursuant to the terms of the Cephalon License, Cephalon will be responsible for all U.S. commercial activities for the product including promotion and distribution, and the Company is responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies. In connection with the Cephalon License, the Company has entered into a supply agreement with Cephalon, pursuant to which the Company is responsible for supplying product to Cephalon. During the quarter-ended September 30, 2016, the Company entered into an amendment to the Cephalon License and supply agreements for Bendeka. This amendment expanded the geographical scope of the rights granted under the original agreement to include territories outside the U.S. and Canada. Additionally, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million in February 2015, earned a $15 million milestone payment related to the FDA approval of Bendeka in December 2015, earned $40 million in November 2016 related to the receipt of a unique, product-specific billing code, J-code (J9034), for Bendeka and earned $25 million in March 2017 for an additional sales-based milestone payment. In addition, the Company was entitled to receive royalty payments of 20% of net sales of the product, which increased to 25% on receipt of the J-code. On August 9, 2016, the Company announced a share repurchase program approved by the Company’s board of directors authorizing the repurchase of up to $75.0 million of the Company’s common stock (the “Share Repurchase Program”). On August 9, 2017, the Company announced a new share repurchase program approved by the Board, under which the Company may repurchase up to an additional $100 million of its outstanding common stock (the “New Share Repurchase Program”). Under the Share Repurchase Program and the New Share Repurchase Program, the Company is authorized to repurchase shares through open market purchases, privately-negotiated transactions 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 Share Repurchase Programs 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. In any period, cash used in financing activities related to shares repurchased may differ from the comparable change in stockholders' equity, reflecting timing differences between the recognition of share repurchase transactions and their settlement for cash. On October 30, 2018, the Company announced that its Board of Directors has approved a new share repurchase program providing for the repurchase of up to $150 million of the Company's outstanding common stock, consisting of (i) up to $50 million in repurchases pursuant to an accelerated share repurchase agreement (the “ASR”) with JPMorgan Chase Bank, N.A. (“JPMorgan”), and (ii) up to $100 million in additional repurchases (the “2018 Share Repurchase Program”). In connection with its approval of the 2018 Share Repurchase Program, the Board terminated the Company’s 2016 Share Repurchase Program and 2017 Share Repurchase Program in October 2018. During the fourth quarter of 2018, the Company repurchased 1,000,134 shares of outstanding common stock for $50 million pursuant to the ASR. The Company repurchased 1,348,563 shares of common stock for $73.1 million during the year ended December 31, 2018 and an aggregate of 2,590,258 shares of common stock for $153.9 million through December 31, 2018. On February 8, 2018, we entered into an amendment (the “Arsia Amendment”) to the stock purchase agreement dated November 10, 2016 (the “Arsia SPA”), pursuant to which we acquired from Arsia Therapeutics, LLC (the “Seller”) all of the outstanding capital stock of Arsia Therapeutics, Inc. Pursuant to the Arsia Amendment, our obligations to make four separate milestone payments pursuant to the Arsia SPA, which could have aggregated to a total of $48 million , were terminated in exchange for a single payment of $15 million to the Seller. 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. 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. Under the License Agreement, SymBio will be responsible for all development of the Products in Japan and for obtaining and maintaining all regulatory approvals of the Products in Japan, with a target for regulatory approval of a Product in Japan in 2020. SymBio will bear all costs of development of the Products in Japan except that, if Japanese regulatory authorities require a certain clinical study to be conducted as a condition for approving one of the Products in Japan, Eagle would share 50% of the out-of-pocket costs of that clinical study up to a specified dollar amount as a reduction to future royalty payments. Based on the Company's assessment of the probability of additional costs, we have not deferred revenue on the Symbio License Agreement. SymBio will also be responsible, at its sole cost, for all marketing, promotion, distribution and sales of the Products in Japan and is obligated to launch the Products and meet certain minimum detailing, promotion and marketing commitments in connection with commercialization of 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. Pursuant to the terms of the SymBio License Agreement, the Company and SymBio will enter into a separate supply agreement, under which the Company will be responsible for manufacturing and supplying the Products to SymBio for development and commercialization in Japan. After a period of time following launch of a Product, SymBio will have the right to assume the responsibility for manufacturing of the Products in and for Japan. Under the SymBio License Agreement, the Company will retain the right to control the prosecution, maintenance and enforcement of the Company’s patents covering the Products, both inside and outside of Japan. Under the SymBio License Agreement, the Company earned an upfront non-refundable cash payment of $12.5 million in the third quarter of 2017, and is eligible to receive a milestone payment upon approval of a Product in Japan and a milestone payment upon achievement of certain cumulative net sales of the Products in Japan, which can aggregate to a total of approximately $10.0 million (subject to currency fluctuations). After regulatory approval of a Product in Japan, the Company will also receive tiered, low double-digit royalties on net sales of the Products in Japan for so long as there are patents covering the Products in Japan or regulatory exclusivity for the Products in Japan. In March 2018, the FDA approved a second manufacturing site for Bendeka. On April 16, 2018, the Company announced the FDA's acceptance of the Company's ANDA filing for vasopressin injection, 1ml. This product is the generic version of Endo International plc's original Vasostrict® formulation, 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. 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. In June 2018, as part of an ongoing organizational review, the Company began a restructuring initiative to rationalize its product portfolio and focus its physical sites. These measures include the discontinuation of manufacture and distribution of Non-Alcohol Docetaxel Injection and plans to rationalize research and development operations. The Company ceased selling the product by September 30, 2018. 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 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. 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 income. 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. 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 13, 2019, we reached a settlement agreement with Eli Lilly and Company related to the Company’s novel product, PEMFEXY™ (pemetrexed for injection), a branded alternative to ALIMTA®. The 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. 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. On January 7, 2020, Tyme Technologies, Inc. and the Company announced a strategic collaboration to advance oral SM-88 for the treatment of patients with cancer. SM-88 is an investigational agent in two Phase 2 studies for pancreatic cancer and in a Phase 2 study for prostate cancer. Data is expected in 2021. On January 9, 2020, we announced that the Company has resubmitted its New Drug Application ("NDA") for Ryanodex®(dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke ("EHS"), in addition to body cooling, to the FDA. Eagle believes that this submission addresses the Complete Response Letter received in July 2017. A Prescription Drug User Fee Act ("PDUFA") date of six months is anticipated for this class of resubmissions. On January 13, 2020, we issued a press release announcing that the Company and the University of Pennsylvania had agreed on terms of a new exclusive worldwide license agreement for the development of dantrolene sodium for the potential treatment of people living with Alzheimer’s disease, including an agreement to fund additional research and provisions regarding commercialization of products developed under the license. On February 10, 2020, we announced that it has received final approval from the FDA for its novel product, PEMFEXY™ (pemetrexed for injection), a branded alternative to ALIMTA®. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies 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. The Company's critical accounting policies are those that are both most important to the Company's 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. 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. Reclassifications Certain reclassifications have been made to prior year amounts to conform with the current year presentation. None of the reclassifications were significant. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. The Company, at times, maintains balances with financial institutions in excess of the FDIC limit. Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. 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. The fair value of the accrued royalty is classified as Level 3 for the period presented. Intangible Assets Other Intangible Assets, Net The Company capitalizes and includes in intangible assets the costs of acquired product licenses and developed technology purchased individually or identified in a business combination. Intangible assets are recorded at fair value at the time of their acquisition and stated net of accumulated amortization. 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 will evaluate the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Events giving rise to impairment are an inherent risk in our industry and many factors cannot be predicted. Factors that we consider in deciding when to perform an impairment review include 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. The impairment test is based on a comparison of the undiscounted cash flows expected to be generated from the use of the asset group and its eventual disposition to the carrying value of the asset group. If impairment is indicated, the asset is written down by the amount by which the carrying value of the asset exceeds the related fair value of the asset with the related impairment charge recognized within the statements of income. With respect to determining an asset’s fair value and useful life, because this process involves management making certain estimates and these estimates form the basis of the determination of whether or not an impairment charge should be recorded, these estimates are considered to be critical accounting estimates. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics acquisition described in Note 11. 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 did not identify any impairment to goodwill during the periods presented. Acquisition-Related Contingent Consideration Contingent consideration related to a business combination is recorded on the acquisition date at the estimated fair value of the contingent payments. The acquisition date fair value is measured based on the consideration expected to be transferred using probability-weighted assumptions and discounted back to present value. The discount rate used is determined at the time of the acquisition in accordance with accepted valuation methods. The fair value of the acquisition-related contingent consideration is re-measured at the estimated fair value at each reporting period with the change in fair value recognized as income or expense in the consolidated statements of income. 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, 2019 2018 2017 Net revenues Cephalon, Inc. (Teva) - See Revenue Recognition 77 % 75 % 79 % Other 23 % 25 % 21 % 100 % 100 % 100 % December 31, 2019 2018 Accounts receivable Cephalon, Inc. (Teva) - See Revenue Recognition 80 % 61 % Other 20 % 39 % 100 % 100 % Inventories Inventories are recorded at the lower of cost or 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. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $2,374 , $3,312 , and $17,770 for the year ended December 31, 2019 , 2018 , and 2017 , 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 on sales to commercial partners relates primarily to Bendeka. Sales to our commercial partners are presented gross because the Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner. 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 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 chargeback 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 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. The Company recorded product sales as follows: Year Ended December 31, 2019 2018 2017 (in thousands) Bendeka $ 31,182 $ 24,568 $ 16,225 Belrapzo 29,665 22,853 — Ryanodex 13,039 20,195 17,500 Other 103 2,769 11,602 Total Product Sales $ 73,989 $ 70,385 $ 45,327 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 for Bendeka 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. As described above, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million , received a milestone payment of $15 million for regulatory approval, received a $40 million milestone upon receipt of the J-Code and received $25 million in an additional sales based milestone payment for reaching $500 million in net product sales of Bendeka. In 2015, $30 million upfront payment was allocated between the license issued to Cephalon and obtaining and maintaining regulatory approvals and conducting post-approval clinical studies using the Company’s best estimate of selling price for each deliverable. The full $30 million was recognized as income in the first quarter of 2015, as the Company substantially completed its requirements for obtaining regulatory approval, which consisted of filing an NDA, on February 13, 2015, and the remaining obligations were estimated to require minimal effort. On December 7, 2015, the FDA approved Bendeka (50 mL bendamustine hydrochloride) marking the achievement of a milestone which entitled the Company to a $15 million payment which was received in January 2016. The Company received a $40 million milestone payment in November 2016 upon receipt of the unique J-Code. Additionally, this event triggered an increase in the royalty rate from 20% to 25% of Bendeka net sales. In March 2017, the Company received a $25 million sales-based milestone payment for reaching $500 million in net product sales. As discussed above, under the SymBio License Agreement, the Company earned an upfront non-refundable cash payment of $12.5 million during the year ended December 31, 2017. In March 2019, the Company and TPIG 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 include an upfront cash payment of $9 million that was recorded as License and other revenue on the consolidated statements of income. 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, 2019 . Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, its allocated overhead, as well as the research and development performed by outside contractors or consultants. Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of income. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement. Stock-Based Compensation The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation - Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors and record expense over the employees' service periods, which are generally the vesting period of the equity awards. The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all stock-based payments made to employees and directors based on estimated grant date fair values. The straight-line method is used to allocate compensation cost to reporting periods over each optionee's requisite service period, which is generally the vesting period. The fair value of the Company's stock-based awards to employees and directors is estimated using the Black-Scholes option valuation model, or Black-Scholes model. The Black-Scholes model requires the input of subjective assumptions, including the expected stock price volatility, the calculation of expected term, forfeitures and the fair value of the underlying common stock on the date of grant, among other inputs. The risk-free interest rate is determined with the implied yield currently available for zero-coupon U.S. government issues with a remaining term approximating the expected life of the options. Earnings Per Share Basic earnings per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. The anti-dilutive common shares equivalents outstanding at December 31, 2019 , 2018 , and 2017 were as follows: Year Ended December 31, 2019 2018 2017 Options 2,454,077 1,824,728 1,592,548 The following table sets forth the computation for basic and diluted net income per share for December 31, 2019 , 2018 , and 2017 : Year Ended December 31, 2019 2018 2017 Numerator Numerator for basic and diluted earnings per share-net income $ 14,313 31,903 $ 51,943 Denominator Basic weighted average common shares outstanding 13,754,516 14,768,625 15,102,890 Dilutive effect of stock options 384,217 510,026 805,321 Diluted weighted average common shares outstanding 14,138,733 15,278,651 15,908,211 Basic net income per share Basic net income per share $ 1.04 $ 2.16 $ 3.44 Diluted net income per share Diluted net income per share $ 1.01 $ 2.09 $ 3.27 Recent Accounting Pronouncements Recent Accounting Pronouncements - Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses which requires financial assets measured at amortized cost basis to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. This standard is effective for fiscal years beginning after December 15, 2019 and we will adopt the standard effective January 1, 2020. We have performed an assessment and determined that adoption will not have a material impact on our consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirement for Fair Value Measurement (“ASU 2018-13”), which amends the disclosure requirements for fair value measurements. The amendments in ASU 2018-13 are effective for fiscal years beginning after December 15, 2019, with early adoption permitted. We have performed an assessment and determined that adoption will not have a material impact on our consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes . The ASU simplifies the accounting for income taxes by removing certain exceptions to the general principles and also clarifies and amends existing guidance. This standard is effective beginning January 1, 2021, with early adoption permitted. We are currently assessing the impact this standard will have on our consolidated financial statements. Recently Adopted Accounting Pronouncements The Company adopted FASB ASU No. 2016-02,“Leases (Topic 842)”("ASU 2016-02") as of January 1, 2019 to increase transparency and comparability among organizations, which included recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Lessees are required to recognize a lease liability, which represents the discounted obligation to make future minimum lease payments, and a corresponding right-of-use asset on the balance sheet for most leases. The Company adopted ASU 2016-02 using the modified retrospective approach and did not recognized a cumulative-effect adjustment to the opening balance of Retained earnings. The Company elected a number of optional practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification and that permits lease agreements that are twelve months or less to be excluded from the balance sheet. The primary impact upon adoption was the recognition, on a discounted basis, of the Company’s minimum commitments under noncancelable operating leases as right of use assets and obligations on the consolidated balance sheets, of approximately $3 million |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: December 31, 2019 2018 Raw materials $ 2,460 $ 6,303 Work in process 3,243 1,776 Finished products 863 225 $ 6,566 $ 8,304 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2019 | |
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) 2019 2018 Furniture and fixtures $ 1,188 $ 1,117 7 Office equipment 1,094 546 3 Equipment 3,095 2,952 7 Leasehold improvements 1,144 1,129 2 6,521 5,744 Less accumulated depreciation (4,319 ) (3,347 ) Property and equipment, net $ 2,202 $ 2,397 Depreciation expense related to property and equipment amounted to $972 and $1,155 for the year ended December 31, 2019 and 2018 , respectively. During the year ended December 31, 2018, as part of the restructuring initiative, the Company recorded an asset impairment charge related to property and equipment, primarily related to leasehold improvements. |
Balance Sheet Accounts
Balance Sheet Accounts | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Prepaid and Other Current Assets Prepaid and other current assets consist of the following: December 31, 2019 2018 Advances to commercial manufacturers $ 2,462 $ 2,700 Prepaid FDA user fee 6,345 1,540 Prepaid insurance 191 150 Prepaid income taxes 4,661 5,739 All other 1,445 134 Total Prepaid expenses and other current assets $ 15,104 $ 10,263 Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consist of the following: December 31, 2019 2018 Accrued expenses Royalties payable to commercial partners $ 6,004 $ 7,139 Accrued research & development 1,686 1,245 Accrued professional fees 1,926 2,408 Accrued salary and other compensation 8,083 5,049 Accrued product costs 8,364 5,869 All other 2,298 1,809 Total Accrued expenses and other liabilities $ 28,361 $ 23,519 Adoption of FASB ASU No. 2016-02, “Leases (Topic 842)” as of January 1, 2019 The Company leases its corporate office under an amended lease agreement that expires on June 30, 2025 (the "Corporate Office Lease"). The Corporate Office Lease was amended on August 8, 2019 to extend the term through such date and to increase the amount of leased office space. The Company also leases lab space under a lease agreement that expires on October 31, 2023 (the "Lab Space Lease"). The Company estimated the right of use asset and the corresponding lease liability, on a discounted basis, as of the adoption date of January 1, 2019. The future minimum lease payments under this Corporate Office Lease are approximately $4.0 million . For the Company's two operating leases (the Corporate Office Lease and Lab Space Lease), the depreciation and interest expense components are combined and recognized ratably over the remaining term of the lease as research and development and selling, general and administrative in the Company's consolidated statements of operations, respectively. The Company used its estimated incremental borrowing rate to calculate the present value of the ROU assets and lease liabilities as of the date of adoption date. The implicit interest rate related to the Company’s two lease agreements was not known as of the date of adoption. Therefore, the Company calculated an incremental borrowing rate based on the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments in a similar economic environment . Lease related disclosures consist of the following: December 31, 2019 Right of use (ROU) asset, net included in Other assets $ 3,716 Lease liability included with Other long-term liabilities $ 3,000 Lease liability included with Accrued expenses and other liabilities $ 1,101 YTD 2019 depreciation of ROU asset $ 1,159 YTD 2019 related rent expense $ 1,146 YTD operating cash flows from operating leases $ 952 YTD operating lease costs $ 1,146 Weighted-average remaining lease term - operating leases 5.0 years Weighted-average discount rate - operating leases 6 % As of December 31, 2019, the future minimum lease commitments for the Company's two leases were as follows: Total 2020 2021 2022 2023 2024 Beyond $ 6,607 $ 1,345 $ 1,362 $ 1,376 $ 1,291 $ 820 $ 413 As of December 31, 2018, the future minimum lease commitments for the Company's two leases were as follows: Total 2019 2020 2021 2022 2023 $ 3,661 $ 1,146 $ 864 $ 583 $ 583 $ 485 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
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 $5 million on the consolidated balance sheet as of December 31, 2019. Per the terms of the Revised Credit Agreement, the Company is limited in its ability to pay dividends. As of December 31, 2019, 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, 2019, the Company had $0.4 million of unamortized deferred debt issuance costs and $0.9 million of unamortized prepaid in its consolidated balance sheets. Debt Maturities As of December 31, 2019 2020 $ 5,000 2021 8,000 2022 26,000 Total $ 39,000 On August 8, 2017, the Company entered into an Amended and Restated Credit Agreement (the “Amended Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative agent (the “Agent”) and the lenders party thereto, which amended and restated the Company’s then existing credit agreement, dated as of January 26, 2017. The Amended Credit Agreement provided for a 3 -year $50 million revolving credit facility and a 3 -year $100 million term loan facility (which are collectively referred to as the “Amended Credit Facility”). The Amended Credit Facility was subject to certain financial covenants. On the date of the amendment, $50 million of the term loan facility was drawn, and none of the revolving credit facility had been drawn. The Amended Credit Facility included a $5 million letter of credit subfacility. Loans under the Amended Credit Facility bore interest, at the Company’s option, 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 Amended Credit Agreement), or (b) the prime lending rate, plus an applicable margin ranging from 1.25% to 2.0% per annum, based upon the total net leverage ratio. The Company was required to pay a commitment fee on the unused portion of the Amended Credit Facility at a rate ranging from 0.35% to 0.45% per annum based upon the total net leverage ratio. The Company was permitted to terminate or reduce the revolving commitments or term commitments of the lenders and to make voluntary prepayments at any time subject to break funding payments. The Company was required to make mandatory prepayments of outstanding indebtedness under the Amended Credit Agreement (a) upon receipt of proceeds from certain sales, transfers or other dispositions, casualty and other condemnation events and the incurrence of certain indebtedness other than indebtedness permitted, subject to customary reinvestment exceptions and (b) in the case that the aggregate amount of all outstanding loans and letters of credit issued under the Amended Credit Facility exceed the aggregate commitment of all lenders under the Amended Credit Facility. The Company was obligated to repay the term loan facility on the last day of each March, June, September and December in an aggregate principal amount equal to 2.5% during the term of the loan. |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Common Stock and Stock-Based Compensation | Common Stock and Stock-Based Compensation Common Stock On October 30, 2018, the Company announced a new repurchase program approved by the Board pursuant to which the Company may repurchase of up to $150 million of the its outstanding common stock, consisting of (i) up to $50 million in repurchases pursuant to an accelerated share repurchase agreement (the “ASR”), with JPMorgan Chase Bank, N.A. (“JPMorgan”), and (ii) up to $100 million in additional repurchases (collectively, the “2018 Share Repurchase Program”). In connection with its approval of the 2018 Share Repurchase Program, the Board terminated the Company’s 2016 Share Repurchase Program and 2017 Share Repurchase Program in October 2018. Under the 2018 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. Under the 2018 Share Repurchase Program, the additional 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. In connection with the 2018 Share Repurchase Program, on October 30, 2018, the Company entered into the ASR with JPMorgan to repurchase an aggregate of $50 million of the Company’s common stock. Under the terms of the ASR, the Company paid $50 million to JP Morgan on November 1, 2018, and received 702,988 shares, representing approximately 80% of the notional amount of the ASR, based on the closing price of $56.90 on October 29, 2018. Upon settlement of the ASR, the final number of shares repurchased were trued up 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. The Company received 297,146 shares on December 6, 2018, the termination date. On August 9, 2016, the Company announced a share repurchase program approved by the Company’s board of directors authorizing the repurchase of up to $75.0 million of the Company’s common stock (the “Share Repurchase Program”). On August 9, 2017, the Company announced a new share repurchase program approved by the Board, under which the Company may repurchase up to an additional $100 million of its outstanding common stock (the “New Share Repurchase Program”). Under the Share Repurchase Program and the New Share Repurchase Program, the Company was authorized to repurchase shares through open market purchases, privately-negotiated transactions 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. We repurchased the following shares of common stock with cash resources: Year Ended December 31, 2019 2018 2017 Shares of common stock repurchased 317,429 1,348,563 674,857 Value of common stock repurchased $ 17,961 $ 73,105 $ 43,792 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. Stock Options The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, 2019 2018 2017 Risk-free interest rate 1.42% - 2.61% 2.30% - 3.07% 1.70% - 2.42% Volatility 40.83% - 50.73% 43.76% 28.56% - 37.63% Expected term (in years) 1.51 - 9.41 years 5.50 - 6.08 years 5.50 - 7.0 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 Stock Option Shares Weighted Average Exercise Price (Per Share) Non- Exercisable Exercisable Outstanding at December 31, 2017 2,786,568 $ 57.13 1,349,339 1,437,229 Granted 672,092 59.17 Exercised (502,322 ) 17.19 Forfeited or expired (399,973 ) Outstanding at December 31, 2018 2,556,365 $ 62.78 1,074,456 1,481,909 Granted 628,133 $ 44.28 Exercised (23,032 ) $ 10.33 Forfeited or expired (65,305 ) Outstanding at December 31, 2019 3,096,161 $ 59.29 1,070,054 2,026,107 The weighted-average grant-date fair value of options granted during the year ended December 31, 2019 , 2018 , and 2017 was $22.18 , $26.73 , and $32.83 , respectively. As of December 31, 2019 , there was $19,051 of unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 2 years. The total intrinsic value of options exercised during the year ended December 31, 2019 was $1,068 . The weighted average contractual terms of options outstanding as of December 31, 2019 , 2018 , and 2017 was 6.8 , 7.3 , and 7.0 years, respectively. The aggregate pre-tax intrinsic value of options outstanding as of December 31, 2019 , 2018 , and 2017 was $31.9 million , $10.7 million , and $33.7 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 Restricted Stock Units Weighted Average Grant Date Fair Value (Per Share) Non-vested at December 31, 2017 — $ — Granted 64,080 59.04 Vested — — Forfeited (9,861 ) $ 59.14 Non-vested at December 31, 2018 54,219 $ 59.02 Granted 211,829 $ 42.17 Vested (13,555 ) $ 59.02 Forfeited (1,278 ) $ 52.19 Non-vested at December 31, 2019 251,215 $ 44.84 As of December 31, 2019 , there was $7,028 of unrecognized stock-based compensation expense related to non-vested RSUs that is expected to be recognized over a weighted average period of 3 years. PSUs 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 2.06% , an expected volatility of 47% , contractual term of 3 years, and no expected dividend yield. The following table summarizes information about PSU activity related to the 2014 Plan: Number of Performance Stock Units Weighted Average Grant Date Fair Value (Per Share) Non-vested at December 31, 2017 — $ — Granted 127,080 90.19 Vested — — Forfeited (9,861 ) $ 90.19 Non-vested at December 31, 2018 117,219 $ 90.19 Granted — $ — Vested — $ — Forfeited (1,038 ) $ 90.19 Non-vested at December 31, 2019 116,181 $ 90.19 As of December 31, 2019 , there was $3,098 of unrecognized stock-based compensation expense related to non-vested PSUs that is expected to be recognized over a weighted average period of 2 years. The Company recognized stock-based compensation in its consolidated statements of income for the year ended December 31, 2019 , 2018 , and 2017 as follows: Year Ended December 31, 2019 2018 2017 Stock options $ 16,394 $ 15,333 $ 15,429 PSUs 3,062 3,059 — RSUs 2,542 690 — Stock-based compensation expense $ 21,998 $ 19,082 $ 15,429 Selling, general and administrative $ 17,556 $ 15,068 $ 11,486 Research and development 4,442 4,014 3,943 Stock-based compensation expense $ 21,998 $ 19,082 $ 15,429 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of our provision from income taxes is as follows: Year Ended December 31, 2019 2018 2017 Current: Federal $ 6,689 $ 4,137 $ 1,304 State 844 466 2,409 $ 7,533 $ 4,603 $ 3,713 Deferred: Federal 392 (2,565 ) 18,045 State (240 ) 97 (756 ) $ 152 $ (2,468 ) $ 17,289 Provision for income taxes $ 7,685 $ 2,135 $ 21,002 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, 2019 2018 2017 Federal statutory tax rate 21 % 21 % 35 % State income taxes, net of federal benefit 2 % 1 % 3 % Tax benefit on stock option exercises, net of forfeitures 1 % (11 )% (4 )% R&D tax credits and Orphan Drug credits (2 )% (7 )% (10 )% Limitation on executive compensation 10 % 3 % N/A Revaluation of net deferred tax assets due to U.S. tax reform — % — % 5 % Change in valuation allowance 4 % — % — % Other (1 )% (1 )% — % Effective tax rate 35 % 6 % 29 % 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, 2019 2018 Deferred tax assets Net operating loss carryforward $ 243 $ — Stock based compensation 10,647 7,934 Research and development and other tax credit carryforwards — 3,251 Inventories 1,539 1,767 Employee-related expenses 51 732 Prepaid R&D expenses 620 761 Intangible assets 662 — ROU asset 925 — Other 1,017 64 Total deferred tax assets 15,704 14,509 Deferred tax liabilities Intangible assets — 280 Prepaid expenses 43 34 Fixed assets 203 282 Lease liability 838 — Other — 91 Total deferred tax liabilities 1,084 687 Valuation allowance (951 ) — Net deferred tax assets $ 13,669 $ 13,822 The Tax Cuts and Jobs Act (the “Tax Act”) enacted on December 22, 2017, significantly revised U.S. corporate income tax law by, among other things, reducing the corporate income tax rate to 21% and implementing a modified territorial tax system. In response to the Tax Act, the SEC issued SAB 118 which allows issuers to recognize provisional estimates of the impact of the Tax Act in their financial statements and adjust in the period in which the estimate becomes finalized, or in circumstances where estimates cannot be made, to disclose and recognize within a one year measurement period. Implementation of the Tax Act resulted in an approximate $3.4 million charge for the revaluation of the Company’s net deferred tax assets during the year ended December 31, 2017. In reaching these estimates, the Company utilized all available guidance and notices issued by the U.S. Department of the Treasury. During 2018, the Company finalized the impact of the Tax Act. An immaterial adjustment was recorded in the year ended December 31, 2018. As a result of attaining profitability and the expectation that substantially all net operating loss carryforwards would be utilized in 2017, the Company performed a formal tax evaluation to determine maximum research and development credits that are available based on current law. As a result of the evaluation of historical records and data, our tax filings, and various tax law interpretations related to the R&D credit availability, additional tax credits were identified. The Company recorded an adjustment of such tax credits of $5.5 million resulting in a reduction of income tax expense in 2017. 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. |
License Agreements of Developme
License Agreements of Development and Commercialization Rights | 12 Months Ended |
Dec. 31, 2019 | |
Research and Development [Abstract] | |
License Agreements of Development and Commercialization Rights | License Agreements of Development and Commercialization Rights Development On February 13, 2015, the Company submitted a New Drug Application or NDA to the FDA for Bendeka, which was approved by the FDA on December 7, 2015. Also, on February 13, 2015, the Company entered into the Cephalon License for U.S. and Canadian rights to Bendeka for treatment of patients with CLL and patients with NHL. Pursuant to the terms of the Cephalon License, Cephalon will be responsible for all U.S. commercial activities for the product including promotion and distribution, and the Company is responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies. Additionally, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million , in January 2016, received a $15 million milestone payment related to the FDA approval of Bendeka in December 2015, received $40 million related to the receipt of the J-code for Bendeka and is currently eligible to receive up to $25 million in an additional sales-based milestone payment. In addition, the Company was entitled to receive royalty payments of 20% of net sales of the product which increased to 25% on receipt of the J-code in November 2016. In connection with the Cephalon License, the Company has entered into a supply agreement with Cephalon, pursuant to which the Company is responsible for supplying product to Cephalon. As of March 29, 2019, the Company and TPIG 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 income. On April 13, 2019, we announced an expansion of our Cephalon License. Under the terms of the revised agreement, beginning on October 1, 2019, Eagle’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 revised agreement also extends the U.S. Bendeka royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. 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. Under the License Agreement, SymBio will be responsible for all development of the Products in Japan and for obtaining and maintaining all regulatory approvals of the Products in Japan, with a target for regulatory approval of a Product in Japan in 2020. SymBio will bear all costs of development of the Products in Japan except that, if Japanese regulatory authorities require a certain clinical study to be conducted as a condition for approving one of the Products in Japan, Eagle would share 50% of the out-of-pocket costs of that clinical study up to a specified dollar amount as a reduction to future royalty payments. Based on the Company's assessment of the probability of additional costs, we have not deferred revenue on the SymBio License Agreement. SymBio will also be responsible, at its sole cost, for all marketing, promotion, distribution and sales of the Products in Japan and is obligated to launch the Products and meet certain minimum detailing, promotion and marketing commitments in connection with commercialization of 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. Pursuant to the terms of the SymBio License Agreement, the Company and SymBio will enter into a separate supply agreement, under which the Company will be responsible for manufacturing and supplying the Products to SymBio for development and commercialization in Japan. After a period of time following launch of a Product, SymBio will have the right to assume the responsibility for manufacturing of the Products in and for Japan. Under the SymBio License Agreement, the Company will retain the right to control the prosecution, maintenance and enforcement of the Company’s patents covering the Products, both inside and outside of Japan. Under the SymBio License Agreement, the Company earned an upfront non-refundable cash payment of $12.5 million in the third quarter of 2017, and is eligible to receive a milestone payment upon approval of a Product in Japan and a milestone payment upon achievement of certain cumulative net sales of the Products in Japan. After regulatory approval of a Product in Japan, the Company will also receive tiered, low double-digit royalties on net sales of the Products in Japan for so long as there are patents covering the Products in Japan or regulatory exclusivity for the Products in Japan. The Company has entered into several product development agreements with development partners whereby the Company acquired the exclusive rights in the United States and, in most cases, worldwide rights to a total of thirty-three products for ten years following first commercial sale of each product. The Company will share varying percentages of the profits after, in most cases, recapturing development, legal and certain operating costs, from the sales of the products with the development partners if the products are commercialized. The Company expenses these costs as incurred. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Our future material contractual obligations include the following: Obligation Total 2020 2021 2022 2023 2024 Beyond Operating leases (1) $ 6,607 $ 1,345 $ 1,362 $ 1,376 $ 1,291 $ 820 $ 413 Credit facility 39,000 5,000 8,000 26,000 — — — Purchase obligations (2) 18,329 18,329 — — — — — Total obligations $ 63,936 $ 24,674 $ 9,362 $ 27,376 $ 1,291 $ 820 $ 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 October 31, 2023. Rental expense was $1,146 , $571 , and $664 , for the years ended December 31, 2019, 2018, and 2017, respectively. The remaining future lease payments under the operating leases, exclusive of any renewal option periods, are $6,607 as of December 31, 2019, payable monthly through June 30, 2025 and October 31, 2023. (2) As of December 31, 2019, the Company has purchase obligations in the amount of $18,329 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. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Acquisitions | Acquisitions Acquisition of Docetaxel-Injection, Non-Alcohol Formula On October 13, 2015, the Company entered into the Teikoku Agreement with Teikoku to market, sell and distribute Non-Alcohol Docetaxel Injection, an investigational product intended for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. The NDA for Non-Alcohol Docetaxel Injection for these indications was approved by the FDA on December 22, 2015. Under the terms of the agreement, the Company paid $4,850 upon FDA approval and NDA transfer to the Company, which occurred on January 12, 2016. The Company also paid 25% royalties on gross profits to Teikoku. The Company accounted for the transaction as a purchase of a business in 2016, in accordance with ASC 805 Business Combinations . The Company has measured the fair value of the future royalty payment using its own assumptions of future profitability of Non-Alcohol Docetaxel Injection. Acquisition contingent consideration is measured at fair value on a recurring basis using unobservable inputs; which accordingly represents a Level 3 measurement within the fair value hierarchy. Any change in fair value of the contingent consideration subsequent to the acquisition date is recognized in operating income within the statement of operations. During the year ended December 31, 2017, the Company recorded a change in the fair value of contingent consideration of $6.2 million . This was primarily driven by adjustments to the fair values of the liabilities associated with Non-Alcohol Docetaxel Injection, which was remeasured due to the loss of a customer and other market conditions identified during the third quarter of 2017 for the product and partially offset by accretion for the time value of money. During the year ended December 31, 2018, the Company recorded an adjustment to the remaining contingent consideration to reflect the Company's decision to discontinue sales of Non-Alcohol Docetaxel Injection. The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability, which was recorded in the Company's consolidated statements of income: Closing Balance December 31, 2016 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2017 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2018 $ 6,940 $ (6,176 ) $ — $ 764 $ (763 ) $ (1 ) $ — Total consideration of $11,220 , which is comprised of the $4,850 cash paid on FDA approval and NDA transfer to the Company and the fair value of contingent consideration has been attributed to the intangible asset for Non-Alcohol Docetaxel Injection product rights. Eagle Biologics Acquisition On November 16, 2016, the Company entered into a stock purchase agreement (“Arsia SPA”) to acquire Arsia Therapeutics (“Arsia” “Seller”), an early-stage biotechnology firm with proprietary viscosity-reducing technology and formulation know-how and subsequently renamed the subsidiary Eagle Biologics, Inc. ("Eagle Biologics"). Under the terms of the stock purchase agreement, we paid approximately $27.2 million in cash and 40,200 shares of Eagle common stock worth $3.0 million at closing. We also agreed to pay up to $48 million in additional payments upon the completion of certain milestones, for aggregate potential payments of $78 million . On February 8, 2018, the Company entered into an amendment (the “Arsia Amendment”) to the Arsia SPA. Pursuant to the Arsia Amendment, the Company's obligation to make four separate milestone payments pursuant to the Arsia SPA, which could have aggregated to a total of $48 million , were terminated in exchange for a single payment of $15 million to the Seller. The acquisition was accounted for as a business combination in accordance with ASC 805, which requires the assets acquired and liabilities assumed from Eagle Biologics to be recorded on the acquisition date at their respective fair values. Eagle Biologics’ results of operations are included in the financial statements from the date of acquisition. The following table summarizes the consideration transferred to acquire Eagle Biologics at the date of acquisition: The aggregate consideration consisted of: Final fair value Cash consideration paid $ 27,209 Common stock issued (i) 3,046 Fair value of contingent consideration payable to seller (long term) (ii) 15,000 Total consideration $ 45,255 (i) Under the stock purchase agreement, the number of common shares to be issued to the seller is equal to $2.7 million divided by the average of the closing day price per share for the 30 trading days prior to the Closing Date. The average price of the common stock of 30 days prior to closing was $68.18 . Accordingly, the number of common stock to be issued to the seller was determined at 40,200 shares ( $2.7 million divided by $68.18 per share). The fair value of the common stock issued was determined based on the closing price of Eagle’s common stock on November 16, 2016. (ii) Under the Arsia SPA, the contingent consideration includes four separate milestone payments which could aggregate to a total of $48 million payable to the Seller upon achievement of certain clinical, regulatory and development milestones. In accordance with the provisions of ASC 805-30-25-5, each unit of contingent consideration is recognized at the acquisition date fair value. The acquisition date fair value of the contingent consideration was $16.1 million . Such fair values are determined based on a probabilistic model with weights assigned on the likelihood of the Company achieving the clinical, regulatory and development milestones as well as an acceleration event in the future. Each unit of contingent consideration is classified as a liability in the balance sheet and would be subsequently measured at fair value on each reporting date. Any future change in fair value would be recognized in the statement of operations. As described above, on February 8, 2018, the Company entered into the Arsia Amendment, pursuant to which the Company’s obligations to make four separate milestone payments under the Arsia SPA were terminated in exchange for a single payment of $15 million to the Seller. During the year ended December 31, 2017, the Company recorded a change in the fair value of contingent consideration of $ 1.2 million related to the Arsia Amendment. The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability, which was recorded in the Company's consolidated statements of income: Closing Balance December 31, 2016 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2017 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2018 $ 16,201 $ (1,201 ) $ — $ 15,000 $ — $ (15,000 ) $ — |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charges Net Book Value Ryanodex intangible 20 $ 15,000 $ (2,454 ) $ — $ 12,546 Developed technology 5 8,100 (5,063 ) — 3,037 Total $ 23,100 $ (7,517 ) $ — $ 15,583 December 31, 2018 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charge Net Book Value Docetaxel product rights 10 $ 11,220 $ (1,281 ) $ (9,939 ) $ — Ryanodex intangible 20 15,000 (1,554 ) — 13,446 Developed technology 5 8,100 (3,443 ) — 4,657 Total $ 34,320 $ (6,278 ) $ (9,939 ) $ 18,103 Amortization expense amounted to $2,520 , $2,515 , and $2,815 , for the year ended December 31, 2019 , 2018 , and 2017 , respectively. Intangible Asset Impairment During the year ended December 31, 2017, the Company experienced a decline in customer contracts and saw a drop in market pricing for Non-Alcohol Docetaxel Injection. Accordingly, the Company estimated the fair value of our Non-Alcohol Docetaxel Injection product and determined the carrying amount of the intangible asset was no longer fully recoverable, resulting in a pre-tax, non-cash asset impairment charge of $7.2 million during the year ended December 31, 2017. On June 30, 2018, the Company implemented a restructuring initiative based on its assessment of the current product portfolio and made a decision to discontinue manufacture and distribution of Non-Alcohol Docetaxel Injection. The Company ceased selling the product by September 30, 2018. As a result, the Company recognized a pre-tax, non-cash asset impairment charge of $2.7 million during the year ended December 31, 2018. Estimated Amortization Expense for Intangible Assets Based on definite-lived intangible assets recorded as of December 31, 2019 , 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, 2020 $ 2,666 2021 2,623 2022 1,369 2023 1,570 2024 1,570 All other 5,785 Total estimated amortization expense $ 15,583 |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal Proceedings In addition to the below legal proceedings, from time to time, the Company 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, the Company currently believes that the final outcome of these ordinary course matters, or matters discussed below, will not have a material adverse effect on the Company's business nor has the Company recorded any loss in connection with these matters because the Company believes that loss is neither probable nor estimable. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. Commercial Litigation In Re: Taxotere (Docetaxel) On February 1, 2017, the Company was named as a defendant, among various other manufacturers, in several product liability suits that are consolidated in the U.S. District Court for the Eastern District of Louisiana as part of MDL 2740 (Civil Action No 2:16 md-2740). The claims are for personal injuries allegedly arising out of the use of docetaxel. In March 2017, the Company reached agreements in principle with the Plaintiffs’ Steering Committee in this matter to voluntarily dismiss the Company from all of the lawsuits in which it was named and from the master complaint. The Company is in the process of working with the other parties in this matter to have it removed from the Multidistrict litigation entirely. As part of the agreement, in the event a case is brought in the future with facts that justify the Company’s inclusion, the plaintiffs reserved the right to include the Company in such matter. The plaintiffs have filed several additional lawsuits since the parties’ agreement in principle to dismiss, and the Company is in the process of working with plaintiffs to explore the possibility of dismissing those lawsuits. Eagle v. Burwell On April 27, 2016, the Company filed an action in the U.S. District Court for the District of Columbia against the FDA and other federal defendants seeking an order requiring the FDA to recognize orphan drug exclusivity for Bendeka for the treatment of CLL and indolent B-cell NHL. On June 8, 2018, the Court issued a decision requiring the FDA to recognize seven years of orphan drug exclusivity in the U.S. for Bendeka, and on July 6, 2018 the FDA recognized such ODE until December 7, 2022. In addition, on July 6, 2018, the FDA submitted a Motion to Alter or Amend the Judgement Pursuant to Rule 59(e), pursuant to which the FDA requested that 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 the FDA had not satisfied the standard for altering or amending the judgment. The FDA and two intervenors have appealed the Court’s final judgment to the U.S. Court of Appeals for the District of Columbia Circuit. Oral arguments occurred on October 17, 2019 and a decision is not expected until the Spring of 2020. On February 20, 2019, the FDA issued a decision in favor of the Company, regarding the scope of exclusivity for Bendeka. Pursuant to the FDA’s decision, and unless the district court is reversed on appeal, no bendamustine product used to treat the same indications (including generic versions of TREANDA) may launch in the United States until December 7, 2022 unless it is clinically superior to Bendeka. Eagle v. Eli Lilly On August 24, 2017, the Company filed an antitrust complaint in the United States District Court for the District of New Jersey (“New Jersey District Court”) against Eli Lilly and Company (“Lilly”). The complaint alleges that Lilly engaged in anticompetitive conduct which restrained competition by delaying and blocking the Company’s launch of a competing pemetrexed injection product (to compete with Lilly’s Alimta). Lilly accepted service and answered the complaint on October 27, 2017. Lilly also filed a motion to transfer this case to Delaware on October 27, 2017. The Company filed a motion to oppose such transfer on November 6, 2017. On July 20, 2018, the New Jersey District Court transferred the case to Delaware. On November 27, 2018, the Delaware Court stayed the case at least until conclusion of the PEMFEXY TM patent trial described below. On December 16, 2019, the Delaware Court entered the Company and Lilly’s stipulation dismissing this case with prejudice. Patent Litigation Eli Lilly and Company. v. Eagle Pharmaceuticals, Inc. (PEMFEXY TM (Pemetrexed)) On August 14, 2017, Lilly filed suit against the Company in the United States District Court for the Southern District of Indiana (the “Indiana Suit”). Lilly alleged patent infringement based on the filing of the Company’s 505(b)(2) NDA seeking approval to manufacture and sell the Company’s EP-5101. EP-5101, if finally approved by FDA, will be a branded alternative to Alimta®. On September 8, 2017, Eagle moved to dismiss the Indiana Suit for improper venue. On September 11, 2017, Lilly voluntarily dismissed the Indiana Suit. It then filed a complaint in the United States District Court for the District of Delaware, alleging similar patent infringement claims (the “Delaware Suit”). Eagle answered and filed various counterclaims in the Delaware Suit on October 3, 2017. Lilly answered Eagle’s counterclaims on October 24, 2017. The Court held a scheduling conference on December 11, 2017 and set trial in the Delaware Suit to begin on September 9, 2019, but later rescheduled trial to begin October 28, 2019. On May 31, 2018, Eagle filed a Motion for Judgment on the Pleadings, which the Court denied on October 26, 2018. On January 23, 2019, the Court held a Markman hearing. Trial took place from October 28, 2019 to October 31, 2019 and is scheduled to continue on December 12, 2019 through December 13, 2019. On December 13, 2019, the Company and Lilly settled this litigation. The agreement provides for a release of all claims by the parties and allows for an initial entry of PEMFEXY TM 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. On December 16, 2019, the District Court entered the Company and Lilly’s stipulation dismissing this case with prejudice. 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.. - (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. Five companies - Slayback Pharma Limited Liability Company (“Slayback”), Apotex Inc. and Apotex Corp. (“Apotex”), Fresenius Kabi USA, LLC (“Fresenius”), Mylan Laboratories Limited (“Mylan”), and Lupin, Ltd. And Lupin Pharmaceuticals, Inc. (“Lupin”)- 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. The Company, Cephalon, Inc. and/or Teva Pharmaceuticals International GMBH (together the “Patentees”), filed separate suits against Slayback, Apotex, Fresenius, Mylan, Hospira, and Lupin 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). 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. 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, and a bench trial in these cases began September 9, 2019 and concluded September 19, 2019. Hospira filed a motion to dismiss the case, 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. Trial is set for November 15, 2021. All cases are pending. The FDA is stayed from approving Apotex’s, Fresenius’, Mylan’s, and Lupin’s ANDA’s, and Hospira’s 505(b)(2) application, until the earlier of (1) January 7, 2020, January 14, 2020, April 30, 2020, November 21, 2021, and December 20, 2020 respectively (the “30-month stay dates”); and (2) a court decision that each of the challenged patents is not infringed, invalid, or unenforceable. The 30-month stay dates may be shortened or lengthened if either party to the action fails to reasonably cooperate in expediting the action. The FDA cannot approve Slayback’s ANDA until March 2031. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company Slayback filed an ANDA referencing Eagle's Belrapzo NDA. Slayback’s ANDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On September 20, 2018, the Company filed a suit against Slayback in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797 and 10,010,533. On October 10, 2018, Slayback answered the Complaint and filed various counterclaims. On October 31, 2018, the Company answered Slayback’s counterclaims. This case is currently stayed. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company Slayback filed a 505(b)(2) NDA referencing Eagle’s Belrapzo NDA. Slayback’s NDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On December 11, 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. 9,265,831, 9,572,796, 9,572,797, and 10,010,533. On January 4, 2019, Slayback filed a motion for judgment on the pleadings. On May 9, 2019, the United States District Court for the District of Delaware granted Slayback’s motion for judgment on the pleadings. On July 23, 2019, the Company filed an appeal of this decision with the United States Court of Appeals for the Federal Circuit. The Federal Circuit scheduled oral argument on March 4, 2020. That appeal is pending. 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 is scheduled to take place on March 3, 2020. Trial is scheduled to begin May 18, 2020. This suit is pending. Eagle Pharmaceuticals, Inc. et al.v. Accord (Argatroban) On March 27, 2019, the Company and Chiesi filed suit against Accord Healthcare, Inc. (“Accord”) in the United States District Court for the District of New Jersey (the “New Jersey suit”) and in the United States District Court for the Middle District of North Carolina (the “North Carolina suit”) (together “the suits”). The suits alleged patent infringement based on Accord’s 505(b)(2) NDA seeking approval to manufacture and sell Accord’s proposed argatroban product. On May 21, 2019, the Company and Chiesi voluntarily dismissed the North Carolina suit. On July 10, 2019, Accord moved for judgment on the pleadings in the New Jersey suit. The New Jersey suit is pending. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data - Unaudited | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data - Unaudited | Selected Quarterly Financial Data - Unaudited A summary of quarterly financial information for the year ended December 31, 2019 and 2018 is as follows: For the Quarter Ended March 31, June 30, September 30, December 31, Total Fiscal Year 2019 2019 2019 2019 2019 (in thousands except share and per share amounts) Revenue $ 49,785 $ 56,702 $ 41,147 $ 48,258 $ 195,892 Gross Profit $ 36,685 $ 35,418 $ 26,225 $ 36,667 $ 134,995 Income (loss) from operations $ 12,169 $ 9,233 $ (2,484 ) $ 2,897 $ 21,815 Net income (loss) $ 8,973 $ 6,725 $ (2,390 ) $ 1,005 $ 14,313 Earnings (loss) per share- basic $ 0.64 $ 0.49 $ (0.17 ) $ 0.08 $ 1.04 Earnings (loss) per share- diluted $ 0.62 $ 0.48 $ (0.17 ) $ 0.08 $ 1.01 For the Quarter Ended March 31, June 30, September 30, December 31, Total Fiscal Year 2018 2018 2018 2018 2018 (in thousands except share and per share amounts) Revenue $ 46,626 $ 59,296 $ 51,337 $ 56,053 $ 213,312 Gross Profit $ 34,818 $ 40,737 $ 38,346 $ 37,495 $ 151,396 Income from operations $ 2,305 $ 183 $ 18,402 $ 15,726 $ 36,616 Net income $ 2,616 $ 2,659 $ 14,040 $ 12,588 $ 31,903 Earnings per share- basic $ 0.18 $ 0.18 $ 0.94 $ 0.86 $ 2.16 Earnings per share- diluted $ 0.17 $ 0.17 $ 0.91 $ 0.84 $ 2.09 |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | Restructuring As part of its ongoing organizational review, the Company engaged in a restructuring initiative to rationalize its product portfolio and focus its physical sites. These measures included the discontinuation of manufacture and distribution of Non-Alcohol Docetaxel Injection in June 2018 and plans to rationalize research and development operations. Charges consist of inventory and related reserves, certain asset impairment charges related to property and equipment, and personnel related costs. The restructuring costs of $7,911 for the year ended December 31, 2018 has been recorded to Restructuring charge on the Consolidated Statements of Income. The Company also recorded an asset impairment charge for the remaining Intangible asset for Non-Alcohol Docetaxel Injection of $2,704 as well as an adjustment to remove the contingent consideration of $790 on the related line items in the Statements of Income for the year ended December 31, 2018. The Company does not expect to incur additional expenses related to this restructuring initiative. There is no liability remaining for the restructuring as of December 31, 2018. |
Related Party Transaction
Related Party Transaction | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transaction | Related Party Transactions During the year ended December 31, 2018, the Company obtained legal services from Greenberg Traurig, LLP in exchange for $0.2 million . Richard A. Edlin, a member of the Company's Board, is an attorney and shareholder of Greenberg Traurig, LLP. 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. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event On January 7, 2020, Tyme Technologies, Inc. ("Tyme") and the Company announced a strategic collaboration to advance oral SM-88 for the treatment of patients with cancer. SM-88 is an investigational agent in two Phase II studies for pancreatic cancer and in a Phase II study for prostate cancer. Data is expected in 2021. Under the terms of the securities purchase agreements, Tyme is entitled to receive up to a total $40 million as follows; (a) an initial $20 million upfront. In return, we will receive 10 million restricted shares of Tyme’s common stock at $2.00 per share; (b) a second $20 million milestone payment upon achieving primary endpoints in pivotal trial results or approval of a cancer indication in the U.S. for SM-88. This payment will be split into a $10 million milestone cash payment and a $10 million investment in Tyme at a 15% premium to the then prevailing market price. Under the terms of the co-promotion agreement, we will be responsible for 25% of the promotional sales effort of SM-88 and will receive 15% of net revenues of SM-88 in the U.S. Tyme retains all commercial rights to SM-88 outside the U.S. and reserves the right to repurchase our U.S. co-promotion right for $200 million |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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. The Company's critical accounting policies are those that are both most important to the Company's 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. 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. |
Reclassifications | Reclassifications |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. The Company, at times, maintains balances with financial institutions in excess of the FDIC limit. |
Fair Value Measurements | Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. 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. The fair value of the accrued royalty is classified as Level 3 for the period presented. |
Intangible Assets | Intangible Assets Other Intangible Assets, Net The Company capitalizes and includes in intangible assets the costs of acquired product licenses and developed technology purchased individually or identified in a business combination. Intangible assets are recorded at fair value at the time of their acquisition and stated net of accumulated amortization. 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 will evaluate the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Events giving rise to impairment are an inherent risk in our industry and many factors cannot be predicted. Factors that we consider in deciding when to perform an impairment review include 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. The impairment test is based on a comparison of the undiscounted cash flows expected to be generated from the use of the asset group and its eventual disposition to the carrying value of the asset group. If impairment is indicated, the asset is written down by the amount by which the carrying value of the asset exceeds the related fair value of the asset with the related impairment charge recognized within the statements of income. With respect to determining an asset’s fair value and useful life, because this process involves management making certain estimates and these estimates form the basis of the determination of whether or not an impairment charge should be recorded, these estimates are considered to be critical accounting estimates. |
Goodwill | Goodwill |
Acquisition-Related Contingent Consideration | Acquisition-Related Contingent Consideration Contingent consideration related to a business combination is recorded on the acquisition date at the estimated fair value of the contingent payments. The acquisition date fair value is measured based on the consideration expected to be transferred using probability-weighted assumptions and discounted back to present value. The discount rate used is determined at the time of the acquisition in accordance with accepted valuation methods. The fair value of the acquisition-related contingent consideration is re-measured at the estimated fair value at each reporting period with the change in fair value recognized as income or expense in the consolidated statements of income. |
Concentration of Major Customers and Vendors | Concentration of Major Customers and Vendors |
Inventories | Inventories Inventories are recorded at the lower of cost or 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. 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. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. |
Advertising and Marketing | Advertising and Marketing |
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 on sales to commercial partners relates primarily to Bendeka. Sales to our commercial partners are presented gross because the Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner. 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 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 chargeback 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 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. The Company recorded product sales as follows: Year Ended December 31, 2019 2018 2017 (in thousands) Bendeka $ 31,182 $ 24,568 $ 16,225 Belrapzo 29,665 22,853 — Ryanodex 13,039 20,195 17,500 Other 103 2,769 11,602 Total Product Sales $ 73,989 $ 70,385 $ 45,327 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 for Bendeka 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. As described above, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million , received a milestone payment of $15 million for regulatory approval, received a $40 million milestone upon receipt of the J-Code and received $25 million in an additional sales based milestone payment for reaching $500 million in net product sales of Bendeka. In 2015, $30 million upfront payment was allocated between the license issued to Cephalon and obtaining and maintaining regulatory approvals and conducting post-approval clinical studies using the Company’s best estimate of selling price for each deliverable. The full $30 million was recognized as income in the first quarter of 2015, as the Company substantially completed its requirements for obtaining regulatory approval, which consisted of filing an NDA, on February 13, 2015, and the remaining obligations were estimated to require minimal effort. On December 7, 2015, the FDA approved Bendeka (50 mL bendamustine hydrochloride) marking the achievement of a milestone which entitled the Company to a $15 million payment which was received in January 2016. The Company received a $40 million milestone payment in November 2016 upon receipt of the unique J-Code. Additionally, this event triggered an increase in the royalty rate from 20% to 25% of Bendeka net sales. In March 2017, the Company received a $25 million sales-based milestone payment for reaching $500 million in net product sales. As discussed above, under the SymBio License Agreement, the Company earned an upfront non-refundable cash payment of $12.5 million during the year ended December 31, 2017. In March 2019, the Company and TPIG 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 include an upfront cash payment of $9 million that was recorded as License and other revenue on the consolidated statements of income. 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, 2019 . Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, its allocated overhead, as well as the research and development performed by outside contractors or consultants. Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of income. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation - Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors and record expense over the employees' service periods, which are generally the vesting period of the equity awards. The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all stock-based payments made to employees and directors based on estimated grant date fair values. The straight-line method is used to allocate compensation cost to reporting periods over each optionee's requisite service period, which is generally the vesting period. The fair value of the Company's stock-based awards to employees and directors is estimated using the Black-Scholes option valuation model, or Black-Scholes model. The Black-Scholes model requires the input of subjective assumptions, including the expected stock price volatility, the calculation of expected term, forfeitures and the fair value of the underlying common stock on the date of grant, among other inputs. The risk-free interest rate is determined with the implied yield currently available for zero-coupon U.S. government issues with a remaining term approximating the expected life of the options. |
Earnings Per Share | Earnings Per Share Basic earnings per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recent Accounting Pronouncements - Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses which requires financial assets measured at amortized cost basis to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. This standard is effective for fiscal years beginning after December 15, 2019 and we will adopt the standard effective January 1, 2020. We have performed an assessment and determined that adoption will not have a material impact on our consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirement for Fair Value Measurement (“ASU 2018-13”), which amends the disclosure requirements for fair value measurements. The amendments in ASU 2018-13 are effective for fiscal years beginning after December 15, 2019, with early adoption permitted. We have performed an assessment and determined that adoption will not have a material impact on our consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes . The ASU simplifies the accounting for income taxes by removing certain exceptions to the general principles and also clarifies and amends existing guidance. This standard is effective beginning January 1, 2021, with early adoption permitted. We are currently assessing the impact this standard will have on our consolidated financial statements. Recently Adopted Accounting Pronouncements The Company adopted FASB ASU No. 2016-02,“Leases (Topic 842)”("ASU 2016-02") as of January 1, 2019 to increase transparency and comparability among organizations, which included recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Lessees are required to recognize a lease liability, which represents the discounted obligation to make future minimum lease payments, and a corresponding right-of-use asset on the balance sheet for most leases. The Company adopted ASU 2016-02 using the modified retrospective approach and did not recognized a cumulative-effect adjustment to the opening balance of Retained earnings. The Company elected a number of optional practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification and that permits lease agreements that are twelve months or less to be excluded from the balance sheet. The primary impact upon adoption was the recognition, on a discounted basis, of the Company’s minimum commitments under noncancelable operating leases as right of use assets and obligations on the consolidated balance sheets, of approximately $3 million |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Revenue from External Customers by Products and Services | The Company recorded product sales as follows: Year Ended December 31, 2019 2018 2017 (in thousands) Bendeka $ 31,182 $ 24,568 $ 16,225 Belrapzo 29,665 22,853 — Ryanodex 13,039 20,195 17,500 Other 103 2,769 11,602 Total Product Sales $ 73,989 $ 70,385 $ 45,327 |
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, 2019 2018 2017 Net revenues Cephalon, Inc. (Teva) - See Revenue Recognition 77 % 75 % 79 % Other 23 % 25 % 21 % 100 % 100 % 100 % December 31, 2019 2018 Accounts receivable Cephalon, Inc. (Teva) - See Revenue Recognition 80 % 61 % Other 20 % 39 % 100 % 100 % |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The anti-dilutive common shares equivalents outstanding at December 31, 2019 , 2018 , and 2017 were as follows: Year Ended December 31, 2019 2018 2017 Options 2,454,077 1,824,728 1,592,548 |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation for basic and diluted net income per share for December 31, 2019 , 2018 , and 2017 : Year Ended December 31, 2019 2018 2017 Numerator Numerator for basic and diluted earnings per share-net income $ 14,313 31,903 $ 51,943 Denominator Basic weighted average common shares outstanding 13,754,516 14,768,625 15,102,890 Dilutive effect of stock options 384,217 510,026 805,321 Diluted weighted average common shares outstanding 14,138,733 15,278,651 15,908,211 Basic net income per share Basic net income per share $ 1.04 $ 2.16 $ 3.44 Diluted net income per share Diluted net income per share $ 1.01 $ 2.09 $ 3.27 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories consist of the following: December 31, 2019 2018 Raw materials $ 2,460 $ 6,303 Work in process 3,243 1,776 Finished products 863 225 $ 6,566 $ 8,304 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consists of the following: December 31, Estimated Useful Life (years) 2019 2018 Furniture and fixtures $ 1,188 $ 1,117 7 Office equipment 1,094 546 3 Equipment 3,095 2,952 7 Leasehold improvements 1,144 1,129 2 6,521 5,744 Less accumulated depreciation (4,319 ) (3,347 ) Property and equipment, net $ 2,202 $ 2,397 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaid and other current assets consist of the following: December 31, 2019 2018 Advances to commercial manufacturers $ 2,462 $ 2,700 Prepaid FDA user fee 6,345 1,540 Prepaid insurance 191 150 Prepaid income taxes 4,661 5,739 All other 1,445 134 Total Prepaid expenses and other current assets $ 15,104 $ 10,263 |
Schedule of Accrued Expenses | Accrued expenses and other liabilities consist of the following: December 31, 2019 2018 Accrued expenses Royalties payable to commercial partners $ 6,004 $ 7,139 Accrued research & development 1,686 1,245 Accrued professional fees 1,926 2,408 Accrued salary and other compensation 8,083 5,049 Accrued product costs 8,364 5,869 All other 2,298 1,809 Total Accrued expenses and other liabilities $ 28,361 $ 23,519 |
Lease related disclosures | Lease related disclosures consist of the following: December 31, 2019 Right of use (ROU) asset, net included in Other assets $ 3,716 Lease liability included with Other long-term liabilities $ 3,000 Lease liability included with Accrued expenses and other liabilities $ 1,101 YTD 2019 depreciation of ROU asset $ 1,159 YTD 2019 related rent expense $ 1,146 YTD operating cash flows from operating leases $ 952 YTD operating lease costs $ 1,146 Weighted-average remaining lease term - operating leases 5.0 years Weighted-average discount rate - operating leases 6 % |
Future minimum lease payments | As of December 31, 2019, the future minimum lease commitments for the Company's two leases were as follows: Total 2020 2021 2022 2023 2024 Beyond $ 6,607 $ 1,345 $ 1,362 $ 1,376 $ 1,291 $ 820 $ 413 |
Future minimum lease payments | As of December 31, 2018, the future minimum lease commitments for the Company's two leases were as follows: Total 2019 2020 2021 2022 2023 $ 3,661 $ 1,146 $ 864 $ 583 $ 583 $ 485 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Long-term Debt | Debt Maturities As of December 31, 2019 2020 $ 5,000 2021 8,000 2022 26,000 Total $ 39,000 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Class of Treasury Stock | We repurchased the following shares of common stock with cash resources: Year Ended December 31, 2019 2018 2017 Shares of common stock repurchased 317,429 1,348,563 674,857 Value of common stock repurchased $ 17,961 $ 73,105 $ 43,792 |
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, 2019 2018 2017 Risk-free interest rate 1.42% - 2.61% 2.30% - 3.07% 1.70% - 2.42% Volatility 40.83% - 50.73% 43.76% 28.56% - 37.63% Expected term (in years) 1.51 - 9.41 years 5.50 - 6.08 years 5.50 - 7.0 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 Stock Option Shares Weighted Average Exercise Price (Per Share) Non- Exercisable Exercisable Outstanding at December 31, 2017 2,786,568 $ 57.13 1,349,339 1,437,229 Granted 672,092 59.17 Exercised (502,322 ) 17.19 Forfeited or expired (399,973 ) Outstanding at December 31, 2018 2,556,365 $ 62.78 1,074,456 1,481,909 Granted 628,133 $ 44.28 Exercised (23,032 ) $ 10.33 Forfeited or expired (65,305 ) Outstanding at December 31, 2019 3,096,161 $ 59.29 1,070,054 2,026,107 |
Schedule of Restricted Stock Unit Activity | The following table summarizes information about RSU activity related to the 2014 Plan: Number of Restricted Stock Units Weighted Average Grant Date Fair Value (Per Share) Non-vested at December 31, 2017 — $ — Granted 64,080 59.04 Vested — — Forfeited (9,861 ) $ 59.14 Non-vested at December 31, 2018 54,219 $ 59.02 Granted 211,829 $ 42.17 Vested (13,555 ) $ 59.02 Forfeited (1,278 ) $ 52.19 Non-vested at December 31, 2019 251,215 $ 44.84 |
Schedule of Phantom Share Unit Activity | The following table summarizes information about PSU activity related to the 2014 Plan: Number of Performance Stock Units Weighted Average Grant Date Fair Value (Per Share) Non-vested at December 31, 2017 — $ — Granted 127,080 90.19 Vested — — Forfeited (9,861 ) $ 90.19 Non-vested at December 31, 2018 117,219 $ 90.19 Granted — $ — Vested — $ — Forfeited (1,038 ) $ 90.19 Non-vested at December 31, 2019 116,181 $ 90.19 |
Schedule of Share-based Compensation Cost | The Company recognized stock-based compensation in its consolidated statements of income for the year ended December 31, 2019 , 2018 , and 2017 as follows: Year Ended December 31, 2019 2018 2017 Stock options $ 16,394 $ 15,333 $ 15,429 PSUs 3,062 3,059 — RSUs 2,542 690 — Stock-based compensation expense $ 21,998 $ 19,082 $ 15,429 Selling, general and administrative $ 17,556 $ 15,068 $ 11,486 Research and development 4,442 4,014 3,943 Stock-based compensation expense $ 21,998 $ 19,082 $ 15,429 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The components of our provision from income taxes is as follows: Year Ended December 31, 2019 2018 2017 Current: Federal $ 6,689 $ 4,137 $ 1,304 State 844 466 2,409 $ 7,533 $ 4,603 $ 3,713 Deferred: Federal 392 (2,565 ) 18,045 State (240 ) 97 (756 ) $ 152 $ (2,468 ) $ 17,289 Provision for income taxes $ 7,685 $ 2,135 $ 21,002 |
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, 2019 2018 2017 Federal statutory tax rate 21 % 21 % 35 % State income taxes, net of federal benefit 2 % 1 % 3 % Tax benefit on stock option exercises, net of forfeitures 1 % (11 )% (4 )% R&D tax credits and Orphan Drug credits (2 )% (7 )% (10 )% Limitation on executive compensation 10 % 3 % N/A Revaluation of net deferred tax assets due to U.S. tax reform — % — % 5 % Change in valuation allowance 4 % — % — % Other (1 )% (1 )% — % Effective tax rate 35 % 6 % 29 % |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company's deferred tax assets were as follows: December 31, 2019 2018 Deferred tax assets Net operating loss carryforward $ 243 $ — Stock based compensation 10,647 7,934 Research and development and other tax credit carryforwards — 3,251 Inventories 1,539 1,767 Employee-related expenses 51 732 Prepaid R&D expenses 620 761 Intangible assets 662 — ROU asset 925 — Other 1,017 64 Total deferred tax assets 15,704 14,509 Deferred tax liabilities Intangible assets — 280 Prepaid expenses 43 34 Fixed assets 203 282 Lease liability 838 — Other — 91 Total deferred tax liabilities 1,084 687 Valuation allowance (951 ) — Net deferred tax assets $ 13,669 $ 13,822 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Commitments | Our future material contractual obligations include the following: Obligation Total 2020 2021 2022 2023 2024 Beyond Operating leases (1) $ 6,607 $ 1,345 $ 1,362 $ 1,376 $ 1,291 $ 820 $ 413 Credit facility 39,000 5,000 8,000 26,000 — — — Purchase obligations (2) 18,329 18,329 — — — — — Total obligations $ 63,936 $ 24,674 $ 9,362 $ 27,376 $ 1,291 $ 820 $ 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 October 31, 2023. Rental expense was $1,146 , $571 , and $664 , for the years ended December 31, 2019, 2018, and 2017, respectively. The remaining future lease payments under the operating leases, exclusive of any renewal option periods, are $6,607 as of December 31, 2019, payable monthly through June 30, 2025 and October 31, 2023. (2) As of December 31, 2019, the Company has purchase obligations in the amount of $18,329 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. |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Schedule of Business Acquisitions by Acquisition, Contingent Consideration | The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability, which was recorded in the Company's consolidated statements of income: Closing Balance December 31, 2016 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2017 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2018 $ 6,940 $ (6,176 ) $ — $ 764 $ (763 ) $ (1 ) $ — The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability, which was recorded in the Company's consolidated statements of income: Closing Balance December 31, 2016 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2017 Changes in fair value Payment of contingent consideration Closing Balance December 31, 2018 $ 16,201 $ (1,201 ) $ — $ 15,000 $ — $ (15,000 ) $ — |
Schedule of Consideration Transferred | The following table summarizes the consideration transferred to acquire Eagle Biologics at the date of acquisition: The aggregate consideration consisted of: Final fair value Cash consideration paid $ 27,209 Common stock issued (i) 3,046 Fair value of contingent consideration payable to seller (long term) (ii) 15,000 Total consideration $ 45,255 (i) Under the stock purchase agreement, the number of common shares to be issued to the seller is equal to $2.7 million divided by the average of the closing day price per share for the 30 trading days prior to the Closing Date. The average price of the common stock of 30 days prior to closing was $68.18 . Accordingly, the number of common stock to be issued to the seller was determined at 40,200 shares ( $2.7 million divided by $68.18 per share). The fair value of the common stock issued was determined based on the closing price of Eagle’s common stock on November 16, 2016. (ii) Under the Arsia SPA, the contingent consideration includes four separate milestone payments which could aggregate to a total of $48 million payable to the Seller upon achievement of certain clinical, regulatory and development milestones. In accordance with the provisions of ASC 805-30-25-5, each unit of contingent consideration is recognized at the acquisition date fair value. The acquisition date fair value of the contingent consideration was $16.1 million . Such fair values are determined based on a probabilistic model with weights assigned on the likelihood of the Company achieving the clinical, regulatory and development milestones as well as an acceleration event in the future. Each unit of contingent consideration is classified as a liability in the balance sheet and would be subsequently measured at fair value on each reporting date. Any future change in fair value would be recognized in the statement of operations. As described above, on February 8, 2018, the Company entered into the Arsia Amendment, pursuant to which the Company’s obligations to make four separate milestone payments under the Arsia SPA were terminated in exchange for a single payment of $15 million |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charges Net Book Value Ryanodex intangible 20 $ 15,000 $ (2,454 ) $ — $ 12,546 Developed technology 5 8,100 (5,063 ) — 3,037 Total $ 23,100 $ (7,517 ) $ — $ 15,583 December 31, 2018 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Accumulated Impairment Charge Net Book Value Docetaxel product rights 10 $ 11,220 $ (1,281 ) $ (9,939 ) $ — Ryanodex intangible 20 15,000 (1,554 ) — 13,446 Developed technology 5 8,100 (3,443 ) — 4,657 Total $ 34,320 $ (6,278 ) $ (9,939 ) $ 18,103 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | Based on definite-lived intangible assets recorded as of December 31, 2019 , 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, 2020 $ 2,666 2021 2,623 2022 1,369 2023 1,570 2024 1,570 All other 5,785 Total estimated amortization expense $ 15,583 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data - Unaudited (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | A summary of quarterly financial information for the year ended December 31, 2019 and 2018 is as follows: For the Quarter Ended March 31, June 30, September 30, December 31, Total Fiscal Year 2019 2019 2019 2019 2019 (in thousands except share and per share amounts) Revenue $ 49,785 $ 56,702 $ 41,147 $ 48,258 $ 195,892 Gross Profit $ 36,685 $ 35,418 $ 26,225 $ 36,667 $ 134,995 Income (loss) from operations $ 12,169 $ 9,233 $ (2,484 ) $ 2,897 $ 21,815 Net income (loss) $ 8,973 $ 6,725 $ (2,390 ) $ 1,005 $ 14,313 Earnings (loss) per share- basic $ 0.64 $ 0.49 $ (0.17 ) $ 0.08 $ 1.04 Earnings (loss) per share- diluted $ 0.62 $ 0.48 $ (0.17 ) $ 0.08 $ 1.01 For the Quarter Ended March 31, June 30, September 30, December 31, Total Fiscal Year 2018 2018 2018 2018 2018 (in thousands except share and per share amounts) Revenue $ 46,626 $ 59,296 $ 51,337 $ 56,053 $ 213,312 Gross Profit $ 34,818 $ 40,737 $ 38,346 $ 37,495 $ 151,396 Income from operations $ 2,305 $ 183 $ 18,402 $ 15,726 $ 36,616 Net income $ 2,616 $ 2,659 $ 14,040 $ 12,588 $ 31,903 Earnings per share- basic $ 0.18 $ 0.18 $ 0.94 $ 0.86 $ 2.16 Earnings per share- diluted $ 0.17 $ 0.17 $ 0.91 $ 0.84 $ 2.09 |
Organization and Business (Deta
Organization and Business (Details) | Oct. 01, 2019 | Sep. 30, 2019 | Dec. 06, 2018shares | Feb. 08, 2018USD ($)milestone_payment | Aug. 08, 2017USD ($) | Nov. 16, 2016USD ($)milestone_paymentshares | Feb. 13, 2015USD ($) | Oct. 31, 2018shares | Mar. 31, 2017USD ($) | Nov. 30, 2016USD ($) | Jan. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Feb. 28, 2015USD ($) | Dec. 31, 2019USD ($)product | Dec. 31, 2018shares | Sep. 30, 2017USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2019USD ($)productsegmentpersonshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2015USD ($) | Dec. 31, 2018USD ($)shares | Oct. 30, 2018USD ($) | Sep. 20, 2017 | Aug. 09, 2017USD ($) | Aug. 09, 2016USD ($) |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Number of products | product | 2 | 2 | ||||||||||||||||||||||||
Number of reportable segments | segment | 1 | |||||||||||||||||||||||||
Stock repurchase program, authorized amount | $ 100,000,000 | $ 75,000,000 | ||||||||||||||||||||||||
Shares of common stock repurchased (in shares) | shares | 317,429 | 1,348,563 | 674,857 | 2,590,258 | ||||||||||||||||||||||
Value of common stock repurchased | $ 17,961,000 | $ 73,105,000 | $ 43,792,000 | $ 153,900,000 | ||||||||||||||||||||||
Clinical development cost sharing percentage (in percentage) | 50.00% | |||||||||||||||||||||||||
Proceeds from upfront license agreement payment | $ 12,500,000 | $ 12,500,000 | ||||||||||||||||||||||||
Potential milestone payments on license agreement | 10,000,000 | |||||||||||||||||||||||||
Teva Pharmaceuticals | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Upfront cash (payment) proceeds for license agreement | 9,000,000 | |||||||||||||||||||||||||
Cephalon, Inc. | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Upfront cash (payment) proceeds for license agreement | $ 25,000,000 | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | |||||||||||||||||||||
Licensing agreement, milestone proceeds | $ 15,000,000 | $ 15,000,000 | ||||||||||||||||||||||||
Licensing agreement, proceeds from unique billing code | $ 40,000,000 | |||||||||||||||||||||||||
Maximum additional milestone payments | $ 25,000,000 | $ 25,000,000 | ||||||||||||||||||||||||
Royalty payments if product is approved, percentage of net sales (in percentage) | 30.00% | 25.00% | 20.00% | 25.00% | ||||||||||||||||||||||
Royalty revenue, percent of net sales threshold (in percentage) | 32.00% | |||||||||||||||||||||||||
Eagle Biologics | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Payment for business acquisition | $ 27,209,000 | |||||||||||||||||||||||||
Shares issued to acquire business (in shares) | shares | 40,200 | |||||||||||||||||||||||||
Business combination, stock consideration transferred, amount | $ 3,046,000 | |||||||||||||||||||||||||
Number of milestone payments | milestone_payment | 4 | |||||||||||||||||||||||||
Milestone Payments | Eagle Biologics | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Contingent consideration liability | $ 48,000,000 | $ 48,000,000 | ||||||||||||||||||||||||
Business combination, consideration transferred, including contingent consideration | $ 78,000,000 | |||||||||||||||||||||||||
Number of milestone payments | milestone_payment | 4 | |||||||||||||||||||||||||
Payment of lump sum milestone arrangement | $ 15,000,000 | |||||||||||||||||||||||||
Amendment Credit Agreement | Minimum | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Commitment fee percentage (in percentage) | 0.35% | |||||||||||||||||||||||||
Amendment Credit Agreement | Maximum | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Commitment fee percentage (in percentage) | 0.45% | |||||||||||||||||||||||||
Revolving Credit Facility | Amendment Credit Agreement | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Credit agreement, term | 3 years | |||||||||||||||||||||||||
Line of credit facility, maximum borrowing capacity | $ 110,000,000 | $ 50,000,000 | $ 50,000,000 | |||||||||||||||||||||||
Letter of Credit | Amendment Credit Agreement | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Line of credit facility, maximum borrowing capacity | $ 5,000,000 | |||||||||||||||||||||||||
Line of Credit | Amendment Credit Agreement | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Credit agreement, term | 3 years | |||||||||||||||||||||||||
Line of credit facility, maximum borrowing capacity | $ 100,000,000 | |||||||||||||||||||||||||
Proceeds from line of credit | $ 50,000,000 | 40,000,000 | ||||||||||||||||||||||||
London Interbank Offered Rate (LIBOR) | Amendment Credit Agreement | Minimum | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Interest rate margin | 2.25% | |||||||||||||||||||||||||
London Interbank Offered Rate (LIBOR) | Amendment Credit Agreement | Maximum | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Interest rate margin | 3.00% | |||||||||||||||||||||||||
Prime Rate | Amendment Credit Agreement | Minimum | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Interest rate margin | 1.25% | |||||||||||||||||||||||||
Prime Rate | Amendment Credit Agreement | Maximum | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Interest rate margin | 2.00% | |||||||||||||||||||||||||
October 2018 Plan | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Stock repurchase program, authorized amount | $ 150,000,000 | |||||||||||||||||||||||||
Accelerated Share Repurchase | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Stock repurchase program, authorized amount | 50,000,000 | |||||||||||||||||||||||||
Shares of common stock repurchased (in shares) | shares | 297,146 | 702,988 | 1,000,134 | |||||||||||||||||||||||
Value of common stock repurchased | $ 50,000,000 | |||||||||||||||||||||||||
Additional Shares | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Stock repurchase program, authorized amount | $ 100,000,000 | |||||||||||||||||||||||||
UNITED STATES | ||||||||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||||||||
Number of people treated for accidental exposure to organophosphate pesticides yearly | person | 2,700 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | Oct. 01, 2019 | Sep. 30, 2019 | Aug. 08, 2017 | Feb. 13, 2015 | Mar. 31, 2017 | Nov. 30, 2016 | Jan. 31, 2016 | Dec. 31, 2015 | Feb. 28, 2015 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2017 | Mar. 31, 2015 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2015 | Jan. 01, 2019 |
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Goodwill impairment | $ 0 | $ 0 | $ 0 | |||||||||||||||||||||
Advertising and marketing costs | 2,374,000 | 3,312,000 | 17,770,000 | |||||||||||||||||||||
Proceeds from upfront license agreement payment | $ 12,500,000 | 12,500,000 | ||||||||||||||||||||||
Total revenue | $ 48,258,000 | $ 41,147,000 | $ 56,702,000 | $ 49,785,000 | $ 56,053,000 | $ 51,337,000 | $ 59,296,000 | $ 46,626,000 | 195,892,000 | 213,312,000 | 236,707,000 | |||||||||||||
Cephalon, Inc. | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Upfront cash proceeds for license agreement | $ 25,000,000 | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | |||||||||||||||||||
Licensing agreement, milestone proceeds | $ 15,000,000 | $ 15,000,000 | ||||||||||||||||||||||
Licensing agreement, proceeds from unique billing code | $ 40,000,000 | |||||||||||||||||||||||
Royalty payments if product is approved, percentage of net sales (in percentage) | 30.00% | 25.00% | 20.00% | 25.00% | ||||||||||||||||||||
Teva Pharmaceuticals | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Upfront cash proceeds for license agreement | $ 9,000,000 | |||||||||||||||||||||||
Bendeka | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Reporting term for partners' net product sales, royalty revenue | 25 days | |||||||||||||||||||||||
Total revenue | $ 31,182,000 | 24,568,000 | 16,225,000 | |||||||||||||||||||||
License | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Total revenue | 9,000,000 | $ 0 | $ 37,500,000 | |||||||||||||||||||||
License | Teva Pharmaceuticals | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Total revenue | $ 9,000,000 | |||||||||||||||||||||||
Teva Pharmaceuticals | Cephalon, Inc. | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Milestone payment benchmark, net sales | $ 500,000,000 | |||||||||||||||||||||||
Minimum | Accounting Standards Update 2016-02 | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Operating lease obligation | $ 3,000,000 | |||||||||||||||||||||||
Maximum | Accounting Standards Update 2016-02 | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Operating lease obligation | $ 4,000,000 | |||||||||||||||||||||||
Line of Credit | Amendment Credit Agreement | ||||||||||||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||||||||||||
Credit agreement, term | 3 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Major Customers as a Percentage (Details) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
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 | 77.00% | 75.00% | 79.00% |
Net Revenues | Other | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 23.00% | 25.00% | 21.00% |
Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 100.00% | 100.00% | |
Accounts Receivable | Cephalon, Inc. | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 80.00% | 61.00% | |
Accounts Receivable | Other | |||
Concentration Risk [Line Items] | |||
Percentage of concentration | 20.00% | 39.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,454,077 | 1,824,728 | 1,592,548 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Product Information [Line Items] | |||||||||||
Total revenue | $ 48,258 | $ 41,147 | $ 56,702 | $ 49,785 | $ 56,053 | $ 51,337 | $ 59,296 | $ 46,626 | $ 195,892 | $ 213,312 | $ 236,707 |
Bendeka | |||||||||||
Product Information [Line Items] | |||||||||||
Total revenue | 31,182 | 24,568 | 16,225 | ||||||||
Belrapzo | |||||||||||
Product Information [Line Items] | |||||||||||
Total revenue | 29,665 | 22,853 | 0 | ||||||||
Ryanodex | |||||||||||
Product Information [Line Items] | |||||||||||
Total revenue | 13,039 | 20,195 | 17,500 | ||||||||
Other | |||||||||||
Product Information [Line Items] | |||||||||||
Total revenue | 103 | 2,769 | 11,602 | ||||||||
Product sales | |||||||||||
Product Information [Line Items] | |||||||||||
Total revenue | $ 73,989 | $ 70,385 | $ 45,327 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Numerator | |||||||||||
Numerator for basic and diluted earnings per share-net income | $ 14,313 | $ 31,903 | $ 51,943 | ||||||||
Denominator | |||||||||||
Basic weighted average common shares outstanding (in shares) | 13,754,516 | 14,768,625 | 15,102,890 | ||||||||
Dilutive effect of stock options (in shares) | 384,217 | 510,026 | 805,321 | ||||||||
Diluted weighted average common shares outstanding (in shares) | 14,138,733 | 15,278,651 | 15,908,211 | ||||||||
Basic net income per share | |||||||||||
Basic (in dollars per share) | $ 0.08 | $ (0.17) | $ 0.49 | $ 0.64 | $ 0.86 | $ 0.94 | $ 0.18 | $ 0.18 | $ 1.04 | $ 2.16 | $ 3.44 |
Diluted net income per share | |||||||||||
Diluted (in dollars per share) | $ 0.08 | $ (0.17) | $ 0.48 | $ 0.62 | $ 0.84 | $ 0.91 | $ 0.17 | $ 0.17 | $ 1.01 | $ 2.09 | $ 3.27 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,460 | $ 6,303 |
Work in process | 3,243 | 1,776 |
Finished products | 863 | 225 |
Inventories | $ 6,566 | $ 8,304 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 6,521 | $ 5,744 |
Less accumulated depreciation | (4,319) | (3,347) |
Property and equipment, net | 2,202 | 2,397 |
Depreciation expense | 972 | 1,155 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,188 | 1,117 |
Estimated Useful Life (years) | 7 years | |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,094 | 546 |
Estimated Useful Life (years) | 3 years | |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 3,095 | 2,952 |
Estimated Useful Life (years) | 7 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,144 | $ 1,129 |
Estimated Useful Life (years) | 2 years |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Balance Sheet Related Disclosures [Abstract] | ||
Advances to commercial manufacturers | $ 2,462 | $ 2,700 |
Prepaid FDA user fee | 6,345 | 1,540 |
Prepaid insurance | 191 | 150 |
Prepaid income taxes | 4,661 | 5,739 |
All other | 1,445 | 134 |
Total Prepaid expenses and other current assets | $ 15,104 | $ 10,263 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Balance Sheet Related Disclosures [Abstract] | ||
Royalties payable to commercial partners | $ 6,004 | $ 7,139 |
Accrued research & development | 1,686 | 1,245 |
Accrued professional fees | 1,926 | 2,408 |
Accrued salary and other compensation | 8,083 | 5,049 |
Accrued product costs | 8,364 | 5,869 |
All other | 2,298 | 1,809 |
Total Accrued expenses and other liabilities | $ 28,361 | $ 23,519 |
Balance Sheet Accounts - Lease
Balance Sheet Accounts - Lease Related Disclosures (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Derivatives, Fair Value [Line Items] | |||
Lessee, Operating Lease, Liability, Payments, Due | $ 6,607 | ||
Right of use (ROU) asset, net included in Other assets | 3,716 | $ 0 | $ 0 |
Lease liability included with Other long-term liabilities | 3,000 | ||
YTD 2019 depreciation of ROU asset | 1,159 | ||
Operating lease cost | 1,146 | ||
YTD operating cash flows from operating leases | $ 952 | ||
Weighted-average remaining lease term - operating leases | 5 years | ||
Weighted-average discount rate - operating leases | 6.00% | ||
Accrued Expensesand Other Liabilities | |||
Derivatives, Fair Value [Line Items] | |||
Lease liability included with Accrued expenses and other liabilities | $ 1,101 | ||
Corporate, non-segment | |||
Derivatives, Fair Value [Line Items] | |||
Lessee, Operating Lease, Liability, Payments, Due | $ 4,000 |
Balance Sheet Accounts - Future
Balance Sheet Accounts - Future Minimum Lease Payments (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2019USD ($)lease | Dec. 31, 2019USD ($)lease | Dec. 31, 2018USD ($)lease | |
Balance Sheet Related Disclosures [Abstract] | |||
Number of operating leases | lease | 2 | 2 | 2 |
2020 | $ 1,345 | $ 1,345 | |
2021 | 1,362 | 1,362 | |
2022 | 1,376 | 1,376 | |
2023 | 1,291 | 1,291 | |
2024 | 820 | 820 | |
Beyond | 413 | 413 | |
Total | $ 6,607 | $ 6,607 | |
Total | $ 3,661 | ||
2020 | 1,146 | ||
2021 | 864 | ||
2022 | 583 | ||
2023 | 583 | ||
2024 | $ 485 |
Debt (Details)
Debt (Details) - USD ($) | Aug. 08, 2017 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Short-term Debt [Line Items] | ||||
Current portion of long-term debt | $ 5,000,000 | $ 5,000,000 | $ 6,250,000 | |
Unamortized debt issuance expense | 400,000 | |||
Unamortized Prepaid Expense | 900,000 | |||
Revolving Credit Facility | Amendment Credit Agreement | ||||
Short-term Debt [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 110,000,000 | 50,000,000 | ||
Credit agreement, term | 3 years | |||
Debt instrument, periodic payments, percent of principal (in percentage) | 2.50% | |||
Line of Credit | Amendment Credit Agreement | ||||
Short-term Debt [Line Items] | ||||
Proceeds from line of credit | $ 50,000,000 | $ 40,000,000 | ||
Line of credit facility, maximum borrowing capacity | $ 100,000,000 | |||
Credit agreement, term | 3 years | |||
Letter of Credit | Amendment Credit Agreement | ||||
Short-term Debt [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 5,000,000 | |||
London Interbank Offered Rate (LIBOR) | Second Amended And Restated Credit Agreement | ||||
Short-term Debt [Line Items] | ||||
Interest rate margin | 1.00% | |||
Minimum | Amendment Credit Agreement | ||||
Short-term Debt [Line Items] | ||||
Commitment fee percentage (in 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 (in 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, 2019USD ($) |
Debt Disclosure [Abstract] | |
2020 | $ 5,000 |
2021 | 8,000 |
2022 | 26,000 |
Total | $ 39,000 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Narrative (Details) - USD ($) | Dec. 06, 2018 | Nov. 01, 2018 | Oct. 29, 2018 | Aug. 04, 2015 | Oct. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Oct. 30, 2018 | Aug. 09, 2017 | Aug. 09, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock repurchase program, authorized amount | $ 100,000,000 | $ 75,000,000 | |||||||||||
Repurchases of common stock | $ 17,961,000 | $ 73,105,000 | $ 43,792,000 | ||||||||||
Shares of common stock repurchased (in shares) | 317,429 | 1,348,563 | 674,857 | 2,590,258 | |||||||||
Share-based payment award, award vesting period | 4 years | ||||||||||||
Number of shares available for grant (in shares) | 1,934,193 | ||||||||||||
Weighted-average grant-date fair value of options granted (in dollars per share) | $ 22.18 | $ 26.73 | $ 32.83 | ||||||||||
Unrecognized compensation cost | $ 19,051,000 | ||||||||||||
Unrecognized compensation cost expense term | 2 years | ||||||||||||
Total intrinsic value of options exercised | $ 1,068,000 | ||||||||||||
Weighted average contractual terms of options outstanding | 6 years 9 months 18 days | 7 years 3 months 18 days | 7 years | ||||||||||
Aggregate pre-tax intrinsic value of options outstanding | $ 10,700,000 | $ 31,900,000 | $ 10,700,000 | $ 33,700,000 | $ 10,700,000 | ||||||||
Common stock | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based payment award, number of additional shares authorized (in shares) | 500,000 | ||||||||||||
RSU | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Unrecognized compensation cost expense term | 3 years | ||||||||||||
Unrecognized compensation cost | $ 7,028,000 | ||||||||||||
PSU | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Unrecognized compensation cost expense term | 2 years | ||||||||||||
Unrecognized compensation cost | $ 3,098,000 | ||||||||||||
Risk free interest rate | 2.06% | ||||||||||||
Expected volatility | 47.00% | ||||||||||||
Expected term (in years) | 3 years | ||||||||||||
October 2018 Plan | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock repurchase program, authorized amount | $ 150,000,000 | ||||||||||||
Accelerated Share Repurchase | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock repurchase program, authorized amount | 50,000,000 | ||||||||||||
Accelerated Share Repurchases, Settlement (Payment) or Receipt | 50,000,000 | ||||||||||||
Repurchases of common stock | $ 50,000,000 | ||||||||||||
Shares of common stock repurchased (in shares) | 297,146 | 702,988 | 1,000,134 | ||||||||||
Percent of authorized shares purchased | 80.00% | ||||||||||||
Closing prince per share of shares acquired (in dollars per share) | $ 56.90 | ||||||||||||
Additional Shares | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock repurchase program, authorized amount | $ 100,000,000 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Schedule of Common Stock Repurchase (Details) - USD ($) $ in Thousands | 12 Months Ended | 36 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | ||||
Shares of common stock repurchased (in shares) | 317,429 | 1,348,563 | 674,857 | 2,590,258 |
Value of common stock repurchased | $ 17,961 | $ 73,105 | $ 43,792 | $ 153,900 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Compensation - Fair Value of Share Options Granted (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest minimum rate | 1.42% | 2.30% | 1.70% |
Risk-free interest maximum rate | 2.61% | 3.07% | 2.42% |
Volatility maximum rate | 50.73% | 43.76% | 28.56% |
Volatility minimum rate | 40.83% | 43.76% | 37.63% |
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) | 1 year 6 months 4 days | 5 years 6 months | 5 years 6 months |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 9 years 4 months 28 days | 6 years 29 days | 7 years |
Common Stock and Stock-Based _6
Common Stock and Stock-Based Compensation - Share-based Compensation, Options (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Outstanding, beginning balance | 2,556,365 | 2,786,568 | |
Granted | 628,133 | 672,092 | |
Exercised | (23,032) | (502,322) | |
Forfeited or expired | (65,305) | (399,973) | |
Outstanding, ending balance (in shares) | 3,096,161 | 2,556,365 | 2,786,568 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | |||
Outstanding, beginning balance | $ 62.78 | $ 57.13 | |
Granted | 44.28 | 59.17 | |
Exercised | 10.33 | 17.19 | |
Outstanding, ending balance | $ 59.29 | $ 62.78 | $ 57.13 |
Non- Exercisable options outstanding (in shares) | 1,070,054 | 1,074,456 | 1,349,339 |
Exercisable options outstanding (in shares) | 2,026,107 | 1,481,909 | 1,437,229 |
Common Stock and Stock-Based _7
Common Stock and Stock-Based Compensation - Schedule of Restricted and Phantom Stock Unit Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
RSU | ||
Number of Restricted Stock Units | ||
Non-vested beginning balance (in shares) | 54,219 | 0 |
Granted (in shares) | 211,829 | 64,080 |
Vested (in shares) | (13,555) | 0 |
Forfeited (in shares) | (1,278) | (9,861) |
Non-vested ending balance (in shares) | 251,215 | 54,219 |
Weighted Average Grant Date Fair Value (Per Share) | ||
Non-vested beginning balance (in dollars per share) | $ 59.02 | $ 0 |
Granted (in dollars per share) | 42.17 | 59.04 |
Vested (in dollars per share) | 59.02 | 0 |
Forfeited (in dollars per share) | 52.19 | 59.14 |
Non-vested ending balance (in dollars per share) | $ 44.84 | $ 59.02 |
PSU | ||
Number of Restricted Stock Units | ||
Non-vested beginning balance (in shares) | 117,219 | 0 |
Granted (in shares) | 0 | 127,080 |
Vested (in shares) | 0 | 0 |
Forfeited (in shares) | (1,038) | (9,861) |
Non-vested ending balance (in shares) | 116,181 | 117,219 |
Weighted Average Grant Date Fair Value (Per Share) | ||
Non-vested beginning balance (in dollars per share) | $ 90.19 | $ 0 |
Granted (in dollars per share) | 0 | 90.19 |
Vested (in dollars per share) | 0 | 0 |
Forfeited (in dollars per share) | 90.19 | 90.19 |
Non-vested ending balance (in dollars per share) | $ 90.19 | $ 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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 21,998 | $ 19,082 | $ 15,429 |
Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 16,394 | 15,333 | 15,429 |
PSU | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 3,062 | 3,059 | 0 |
RSU | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 2,542 | 690 | 0 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 17,556 | 15,068 | 11,486 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 4,442 | $ 4,014 | $ 3,943 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax (Benefit) Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Current: | |||
Federal | $ 6,689 | $ 4,137 | $ 1,304 |
State | 844 | 466 | 2,409 |
Total | 7,533 | 4,603 | 3,713 |
Deferred: | |||
Federal | 392 | (2,565) | 18,045 |
State | (240) | 97 | (756) |
Total | 152 | (2,468) | 17,289 |
Provision for income taxes | $ 7,685 | $ 2,135 | $ 21,002 |
Income Taxes - Reconciliation (
Income Taxes - Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory tax rate | 21.00% | 21.00% | 35.00% |
State income taxes, net of federal benefit | 2.00% | 1.00% | 3.00% |
Tax benefit on stock option exercises, net of forfeitures | 1.00% | (11.00%) | (4.00%) |
R&D tax credits and Orphan Drug credits | (2.00%) | (7.00%) | (10.00%) |
Limitation on executive compensation | 10.00% | 3.00% | |
Revaluation of net deferred tax assets due to U.S. tax reform | 0 | 0 | 0.05 |
Change in valuation allowance | 4.00% | 0.00% | 0.00% |
Other | (1.00%) | (1.00%) | 0.00% |
Effective tax rate | 35.00% | 6.00% | 29.00% |
Income Taxes - Deferred Income
Income Taxes - Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets | ||
Net operating loss carryforward | $ 243 | $ 0 |
Stock based compensation | 10,647 | 7,934 |
Research and development and other tax credit carryforwards | 0 | 3,251 |
Inventories | 1,539 | 1,767 |
Employee-related expenses | 51 | 732 |
Prepaid R&D expenses | 620 | 761 |
Intangible assets | 662 | 0 |
Deferred Tax Assets, Property, Plant and Equipment | 925 | 0 |
Other | 1,017 | 64 |
Total deferred tax assets | 15,704 | 14,509 |
Deferred tax liabilities | ||
Intangible assets | 0 | 280 |
Prepaid expenses | 43 | 34 |
Fixed assets | 203 | 282 |
Deferred Tax Liabilities, Leasing Arrangements | 838 | 0 |
Other | 0 | 91 |
Total deferred tax liabilities | 1,084 | 687 |
Valuation allowance | (951) | 0 |
Net deferred tax assets | $ 13,669 | $ 13,822 |
Income Taxes - Narrative (Deta
Income Taxes - Narrative (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Tax expense as result of remeasurment of deferred tax asset due to Tax Cuts and Jobs Act | $ 3.4 |
Research And Development Tax Credit | |
Operating Loss Carryforwards [Line Items] | |
Adjustment to income tax credit, reduction in income tax expense | $ 5.5 |
License Agreements of Develop_2
License Agreements of Development and Commercialization Rights (Details) | Oct. 01, 2019 | Sep. 30, 2019 | Feb. 13, 2015USD ($) | Mar. 31, 2017USD ($) | Nov. 30, 2016USD ($) | Jan. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Feb. 28, 2015USD ($) | Sep. 30, 2017USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2019USD ($)product | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Sep. 20, 2017 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Clinical development cost sharing percentage (in percentage) | 50.00% | |||||||||||||
Proceeds from upfront license agreement payment | $ 12,500,000 | $ 12,500,000 | ||||||||||||
Number of products with exclusivity rights | product | 33 | |||||||||||||
Marketing rights, term | 10 years | |||||||||||||
Cephalon, Inc. | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Upfront cash (payment) proceeds for license agreement | $ 25,000,000 | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | |||||||||
Licensing agreement, milestone proceeds | $ 15,000,000 | $ 15,000,000 | ||||||||||||
Licensing agreement, proceeds from unique billing code | $ 40,000,000 | |||||||||||||
Maximum additional milestone payments | $ 25,000,000 | $ 25,000,000 | ||||||||||||
Royalty payments if product is approved, percentage of net sales (in percentage) | 30.00% | 25.00% | 20.00% | 25.00% | ||||||||||
Royalty revenue, percent of net sales threshold (in percentage) | 32.00% | |||||||||||||
Teva Pharmaceuticals | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Upfront cash (payment) proceeds for license agreement | $ 9,000,000 |
Commitments - Future Minimum Le
Commitments - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating lease obligations | |||
Total | $ 6,607 | ||
2020 | 1,345 | ||
2021 | 1,362 | ||
2022 | 1,376 | ||
2023 | 1,291 | ||
2024 | 820 | ||
Beyond | 413 | ||
Credit facility | |||
Total | 39,000 | ||
2020 | 5,000 | ||
2021 | 8,000 | ||
2022 | 26,000 | ||
2023 | 0 | ||
2024 | 0 | ||
Beyond | 0 | ||
Purchase obligations | |||
Total | 18,329 | ||
2020 | 18,329 | ||
2021 | 0 | ||
2022 | 0 | ||
2023 | 0 | ||
2024 | 0 | ||
Beyond | 0 | ||
Total obligations | |||
Total | 63,936 | ||
2020 | 24,674 | ||
2021 | 9,362 | ||
2022 | 27,376 | ||
2023 | 1,291 | ||
2024 | 820 | ||
Beyond | 413 | ||
Operating lease rent expense | $ 1,146 | ||
Operating leases rent expense | $ 571 | $ 664 |
Acquisitions - Narrative (Deta
Acquisitions - Narrative (Details) | Feb. 08, 2018USD ($)milestone_payment | Nov. 16, 2016USD ($)milestone_paymentshares | Jan. 12, 2016USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Business Acquisition [Line Items] | ||||||
Change in fair value of contingent consideration | $ 0 | $ (763,000) | $ (7,377,000) | |||
Non-Alcohol Docetaxel Injection | ||||||
Business Acquisition [Line Items] | ||||||
Change in fair value of contingent consideration | 6,200,000 | |||||
Eagle Biologics | ||||||
Business Acquisition [Line Items] | ||||||
Payment for business acquisition | $ 27,209,000 | |||||
Change in fair value of contingent consideration | $ 0 | $ (1,201,000) | $ 1,200,000 | |||
Business combination, consideration transferred | $ 45,255,000 | |||||
Shares issued to acquire business (in shares) | shares | 40,200 | |||||
Business combination, stock consideration transferred, amount | $ 3,046,000 | |||||
Number of milestone payments | milestone_payment | 4 | |||||
Docetaxel product rights | Non-Alcohol Docetaxel Injection | ||||||
Business Acquisition [Line Items] | ||||||
Payment for business acquisition | $ 4,850,000 | |||||
Business combination, consideration transferred | $ 11,220,000 | |||||
Royalties on Gross Profits | Docetaxel product rights | Non-Alcohol Docetaxel Injection | ||||||
Business Acquisition [Line Items] | ||||||
Royalties, percentage of gross profits | 25.00% | |||||
Milestone Payments | Eagle Biologics | ||||||
Business Acquisition [Line Items] | ||||||
Contingent consideration liability | $ 48,000,000 | $ 48,000,000 | ||||
Business combination, consideration transferred, including contingent consideration | $ 78,000,000 | |||||
Number of milestone payments | milestone_payment | 4 | |||||
Payment of lump sum milestone arrangement | $ 15,000,000 |
Acquisitions - Schedule of Cont
Acquisitions - Schedule of Contingent Consideration Fair Value, Docetaxel (Details) - Contingent Consideration Liability - Non-Alcohol Docetaxel Injection - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Contingent Consideration Liability, Fair Value Rollfoward | ||
Contingent consideration liability, fair value, beginning balance | $ 764 | $ 6,940 |
Changes in fair value | (763) | (6,176) |
Payment of contingent consideration | (1) | 0 |
Contingent consideration liability, fair value, ending balance | $ 0 | $ 764 |
Acquisitions - Schedule of Cons
Acquisitions - Schedule of Consideration Transferred, Biologics (Details) - Eagle Biologics | Feb. 08, 2018USD ($)milestone_payment | Nov. 16, 2016USD ($)milestone_payment$ / sharesshares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Business Acquisition [Line Items] | |||||
Cash consideration paid | $ 27,209,000 | ||||
Common stock issued | 3,046,000 | ||||
Fair value of contingent consideration payable to seller (long term) | 15,000,000 | ||||
Total consideration | 45,255,000 | ||||
Common shares to be issued value | $ 2,700,000 | ||||
Average share price, trading days | 30 days | ||||
Business acquisition, share price (in dollars per share) | $ / shares | $ 68.18 | ||||
Shares issued to acquire business (in shares) | shares | 40,200 | ||||
Number of milestone payments | milestone_payment | 4 | ||||
Acquisition date fair value of contingent consideration | $ 0 | $ 15,000,000 | $ 16,201,000 | ||
Milestone Payments | |||||
Business Acquisition [Line Items] | |||||
Number of milestone payments | milestone_payment | 4 | ||||
Contingent consideration liability | $ 48,000,000 | $ 48,000,000 | |||
Acquisition date fair value of contingent consideration | $ 16,100,000 | ||||
Payment of lump sum milestone arrangement | $ 15,000,000 |
Acquisitions - Schedule of Co_2
Acquisitions - Schedule of Contingent Consideration, Biologic (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Contingent Consideration Liability [Roll Forward] | |||
Change in fair value of contingent consideration | $ 0 | $ (763) | $ (7,377) |
Payment of contingent consideration | 0 | (15,000) | 0 |
Eagle Biologics | |||
Contingent Consideration Liability [Roll Forward] | |||
Opening balance | 15,000 | 16,201 | |
Change in fair value of contingent consideration | 0 | (1,201) | 1,200 |
Payment of contingent consideration | (15,000) | 0 | |
Closing balance | $ 0 | $ 15,000 | $ 16,201 |
Intangible Assets, Net - Sched
Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 23,100 | $ 34,320 |
Accumulated Amortization | (7,517) | (6,278) |
Accumulated Impairment Charges | 0 | (9,939) |
Net Book Value | $ 15,583 | $ 18,103 |
Docetaxel product rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 10 years | |
Gross Carrying Amount | $ 11,220 | |
Accumulated Amortization | (1,281) | |
Accumulated Impairment Charges | (9,939) | |
Net Book Value | $ 0 | |
Ryanodex intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful Life (In Years) | 20 years | 20 years |
Gross Carrying Amount | $ 15,000 | $ 15,000 |
Accumulated Amortization | (2,454) | (1,554) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 12,546 | $ 13,446 |
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 | (5,063) | (3,443) |
Accumulated Impairment Charges | 0 | 0 |
Net Book Value | $ 3,037 | $ 4,657 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization expense | $ 2,520 | $ 2,515 | $ 2,815 |
Asset impairment charge | $ 0 | 2,704 | 7,235 |
Docetaxel product rights | |||
Finite-Lived Intangible Assets [Line Items] | |||
Asset impairment charge | $ 2,700 | $ 7,200 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2020 | $ 2,666 | |
2021 | 2,623 | |
2022 | 1,369 | |
2023 | 1,570 | |
2024 | 1,570 | |
All other | 5,785 | |
Net Book Value | $ 15,583 | $ 18,103 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data - Unaudited (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 48,258 | $ 41,147 | $ 56,702 | $ 49,785 | $ 56,053 | $ 51,337 | $ 59,296 | $ 46,626 | $ 195,892 | $ 213,312 | $ 236,707 |
Gross Profit | 36,667 | 26,225 | 35,418 | 36,685 | 37,495 | 38,346 | 40,737 | 34,818 | 134,995 | 151,396 | |
Income (Loss) from operations | 2,897 | (2,484) | 9,233 | 12,169 | 15,726 | 18,402 | 183 | 2,305 | 21,815 | 36,616 | $ 73,990 |
Net income (loss) attributable to common stockholders | $ 1,005 | $ (2,390) | $ 6,725 | $ 8,973 | $ 12,588 | $ 14,040 | $ 2,659 | $ 2,616 | $ 14,313 | $ 31,903 | |
Earnings (loss) per share - basic (in dollars per share) | $ 0.08 | $ (0.17) | $ 0.49 | $ 0.64 | $ 0.86 | $ 0.94 | $ 0.18 | $ 0.18 | $ 1.04 | $ 2.16 | $ 3.44 |
Earnings (loss) per share - diluted (in dollars per share) | $ 0.08 | $ (0.17) | $ 0.48 | $ 0.62 | $ 0.84 | $ 0.91 | $ 0.17 | $ 0.17 | $ 1.01 | $ 2.09 | $ 3.27 |
Restructuring - Narrative (Deta
Restructuring - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charge | $ 0 | $ 7,911,000 | $ 0 |
Asset impairment charge | 0 | 2,704,000 | 7,235,000 |
Decrease in contingent consideration | $ 0 | 763,000 | 7,377,000 |
Product Portfolio Rationalization | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring reserve | 0 | ||
Non-Alcohol Docetaxel Injection | |||
Restructuring Cost and Reserve [Line Items] | |||
Decrease in contingent consideration | $ (6,200,000) | ||
Non-Alcohol Docetaxel Injection | Product Portfolio Rationalization | |||
Restructuring Cost and Reserve [Line Items] | |||
Decrease in contingent consideration | 790,000 | ||
Non-Alcohol Docetaxel Injection | Product Portfolio Rationalization | |||
Restructuring Cost and Reserve [Line Items] | |||
Asset impairment charge | $ 2,704,000 |
Related Party Transaction (Deta
Related Party Transaction (Details) - USD ($) $ / shares in Units, $ in Millions | May 10, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 |
Related Party Transaction [Line Items] | |||||
Shares of common stock repurchased (in shares) | 317,429 | 1,348,563 | 674,857 | 2,590,258 | |
Richard A. Edlin | |||||
Related Party Transaction [Line Items] | |||||
Shares of common stock repurchased (in shares) | 100,000 | ||||
Block trade closing price (in USD per share) | $ 56.14 | ||||
Richard A. Edlin | Legal Services | |||||
Related Party Transaction [Line Items] | |||||
Transaction with related party | $ 0.2 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent event $ / shares in Units, shares in Millions, $ in Millions | Jan. 07, 2020USD ($)$ / sharesshares |
Subsequent Event [Line Items] | |
Total value | $ 40 |
Upfront amount due | $ 20 |
Number of shares Receivable (in shares) | shares | 10 |
Shares receivable, price per share (in USD per share) | $ / shares | $ 2 |
Second milestone payment due | $ 20 |
Second milestone payment in cash payment due | 10 |
Second milestone payment in investment due | $ 10 |
Premium on investment prevailing market price (in percentage) | 15.00% |
Co-promotion agreement, percentage of promotional sales effort responsible for (in percentage) | 25.00% |
Co-promotion agreement, percentage of net revenue receivable (in percentage) | 15.00% |
Co-promotion agreement, right to repurchase, amount | $ 200 |