Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 02, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36306 | |
Entity Registrant Name | Eagle Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-8179278 | |
Entity Address, Address Line One | 50 Tice Boulevard | |
Entity Address, Address Line Two | Suite 315 | |
Entity Address, City or Town | Woodcliff Lake | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07677 | |
City Area Code | (201) | |
Local Phone Number | 326-5300 | |
Title of 12(b) Security | Common stock, $0.001 par value per share | |
Trading Symbol | EGRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 13,015,856 | |
Entity Central Index Key | 0000827871 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 15,384 | $ 97,659 |
Accounts receivable, net | 96,932 | 41,149 |
Inventories | 63,855 | 21,908 |
Prepaid expenses and other current assets | 8,875 | 11,890 |
Total current assets | 185,046 | 172,606 |
Property and equipment, net | 1,297 | 1,636 |
Intangible assets, net | 108,785 | 10,671 |
Goodwill | 41,794 | 39,743 |
Deferred tax asset, net | 23,541 | 18,798 |
Other assets | 25,986 | 10,278 |
Total assets | 386,449 | 253,732 |
Current liabilities: | ||
Accounts payable | 13,215 | 16,431 |
Accrued expenses and other liabilities | 73,652 | 32,338 |
Current debt | 34,961 | 25,607 |
Total current liabilities | 121,828 | 74,376 |
Long-term debt | 26,431 | 0 |
Deferred tax liability | 4,536 | 0 |
Other long-term liabilities | 1,874 | 2,903 |
Total liabilities | 154,669 | 77,279 |
Commitments and Contingencies | ||
Stockholders' equity: | ||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of September 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 17,568,586 and 16,903,034 shares issued as of September 30, 2022 and December 31, 2021, respectively | 18 | 17 |
Additional paid in capital | 362,161 | 325,779 |
Accumulated other comprehensive income (loss) | 9,377 | (94) |
Retained earnings | 103,339 | 75,862 |
Treasury stock, at cost, 4,552,730 and 4,111,622 shares as of September 30, 2022 and December 31, 2021, respectively | (243,115) | (225,111) |
Total stockholders' equity | 231,780 | 176,453 |
Total liabilities and stockholders' equity | $ 386,449 | $ 253,732 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized (in shares) | 1,500,000 | 1,500,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 17,568,586 | 16,903,034 |
Treasury stock (in shares) | 4,552,730 | 4,111,622 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Total revenue | $ 65,901 | $ 39,853 | $ 255,911 | $ 129,226 |
Operating expenses: | ||||
Cost of product sales | 20,869 | 5,486 | 67,216 | 21,835 |
Cost of royalty revenue | 2,782 | 2,773 | 7,854 | 8,036 |
Research and development | 9,326 | 23,289 | 26,871 | 47,488 |
Selling, general and administrative | 23,462 | 18,482 | 82,476 | 54,997 |
Total operating expenses | 56,439 | 50,030 | 184,417 | 132,356 |
Income (loss) from operations | 9,462 | (10,177) | 71,494 | (3,130) |
Interest income | (444) | 197 | (46) | 395 |
Interest expense | (1,147) | (396) | (2,065) | (1,240) |
Other expense | (11,534) | (2,284) | (21,254) | (1,797) |
Total other expense, net | (13,125) | (2,483) | (23,365) | (2,642) |
(Loss) income before income tax (provision) benefit | (3,663) | (12,660) | 48,129 | (5,772) |
Income tax (provision) benefit | (3,468) | 7,038 | (20,652) | 3,341 |
Net (loss) income | $ (7,131) | $ (5,622) | $ 27,477 | $ (2,431) |
(Loss) earnings per share attributable to common stockholders: | ||||
Basic (in dollars per share) | $ (0.54) | $ (0.43) | $ 2.13 | $ (0.19) |
Diluted (in dollars per share) | $ (0.54) | $ (0.43) | $ 2.11 | $ (0.19) |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 13,166,931 | 13,077,298 | 12,906,235 | 13,103,203 |
Diluted (in shares) | 13,166,931 | 13,077,298 | 13,051,311 | 13,103,203 |
Product sales, net | ||||
Revenue: | ||||
Total revenue | $ 38,086 | $ 12,124 | $ 177,375 | $ 48,865 |
Royalty revenue | ||||
Revenue: | ||||
Total revenue | 24,007 | 27,729 | 74,728 | 80,361 |
License and other revenue | ||||
Revenue: | ||||
Total revenue | $ 3,808 | $ 0 | $ 3,808 | $ 0 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $ (7,131) | $ (5,622) | $ 27,477 | $ (2,431) |
Other comprehensive income (loss), net of tax: | ||||
Unrealized gain (loss) for convertible promissory note | (510) | 22 | 94 | (882) |
Foreign currency translation | 7,606 | 0 | 9,377 | 0 |
Total other comprehensive income (loss) | 7,096 | 22 | 9,471 | (882) |
Comprehensive (loss) income | $ (35) | $ (5,600) | $ 36,948 | $ (3,313) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Treasury Stock | Accumulated Other Comprehensive Income | Retained Earnings |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Beginning balance (in shares) | 16,739,000 | |||||
Beginning balance at Dec. 31, 2020 | $ 186,011 | $ 17 | $ 305,403 | $ (203,898) | $ 0 | $ 84,489 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 14,873 | 14,873 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 100,477 | 84,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 1,841 | 1,841 | ||||
Issuance of common stock related to vesting of restricted stock units (in shares) | 63,000 | |||||
Issuance of common stock related to vesting of restricted stock units | (1,551) | (1,551) | ||||
Common stock repurchases | (12,568) | (12,568) | ||||
Other comprehensive income | (882) | (882) | ||||
Net income (loss) | (2,431) | (2,431) | ||||
Ending balance (in shares) at Sep. 30, 2021 | 16,886,000 | |||||
Ending balance at Sep. 30, 2021 | 185,293 | $ 17 | 320,566 | (216,466) | (882) | 82,058 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Beginning balance (in shares) | 16,880,000 | |||||
Beginning balance at Jun. 30, 2021 | 194,847 | $ 17 | 316,249 | (208,195) | (904) | 87,680 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 4,084 | 4,084 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 6,000 | |||||
Issuance of common stock upon exercise of stock option grants | 233 | 233 | ||||
Common stock repurchases | (8,271) | (8,271) | ||||
Other comprehensive income | 22 | 22 | ||||
Net income (loss) | (5,622) | (5,622) | ||||
Ending balance (in shares) at Sep. 30, 2021 | 16,886,000 | |||||
Ending balance at Sep. 30, 2021 | 185,293 | $ 17 | 320,566 | (216,466) | (882) | 82,058 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Beginning balance (in shares) | 16,886,000 | |||||
Beginning balance (in shares) | 16,903,000 | |||||
Beginning balance at Dec. 31, 2021 | 176,453 | $ 17 | 325,779 | (225,111) | (94) | 75,862 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 12,332 | 12,332 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 91,255 | 76,000 | ||||
Issuance of common stock upon exercise of stock option grants | $ 1,747 | 1,747 | ||||
Issuance of common stock related to business acquisition (in shares) | 516,000 | |||||
Issuance of common stock related to business acquisition | 23,645 | $ 1 | 23,644 | |||
Issuance of common stock related to vesting of restricted stock units (in shares) | 74,000 | |||||
Issuance of common stock related to vesting of restricted stock units | (1,341) | (1,341) | ||||
Common stock repurchases | (18,004) | (18,004) | ||||
Other comprehensive income | 9,471 | 9,471 | ||||
Net income (loss) | 27,477 | 27,477 | ||||
Ending balance (in shares) at Sep. 30, 2022 | 17,569,000 | |||||
Ending balance at Sep. 30, 2022 | 231,780 | $ 18 | 362,161 | (243,115) | 9,377 | 103,339 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Beginning balance (in shares) | 17,549,000 | |||||
Beginning balance at Jun. 30, 2022 | 237,982 | $ 18 | 358,377 | (233,164) | 2,281 | 110,470 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 3,537 | 3,537 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 20,000 | |||||
Issuance of common stock upon exercise of stock option grants | 247 | 247 | ||||
Common stock repurchases | (9,951) | (9,951) | ||||
Other comprehensive income | 7,096 | 7,096 | ||||
Net income (loss) | (7,131) | (7,131) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 17,569,000 | |||||
Ending balance at Sep. 30, 2022 | $ 231,780 | $ 18 | $ 362,161 | $ (243,115) | $ 9,377 | $ 103,339 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Beginning balance (in shares) | 17,569,000 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 27,477 | $ (2,431) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||
Deferred income taxes | (4,743) | (2,533) |
Depreciation expense | 508 | 575 |
Noncash operating lease expense related to right-of-use assets | 917 | 768 |
Amortization expense of intangible assets | 5,886 | 2,118 |
Fair value adjustments on equity investment | 3,208 | 1,900 |
Stock-based compensation expense | 12,332 | 14,873 |
Amortization of debt issuance costs | 354 | 354 |
Fair value adjustments related to derivative instruments | 962 | (254) |
Accretion of discount on convertible promissory note | 0 | (102) |
Loss on foreign currency exchange rates | 7,309 | 0 |
Loss on write-off of promissory note | 4,444 | 150 |
Changes in operating assets and liabilities which provided (used) cash: | ||
Accounts receivable | (55,325) | 5,343 |
Inventories | (15,006) | (1,240) |
Prepaid expenses and other current assets | (831) | (8,821) |
Accounts payable | (3,824) | 6,449 |
Accrued expenses and other liabilities | 33,888 | 3,897 |
Other assets and other long-term liabilities, net | (4,412) | (908) |
Net cash provided by operating activities | 13,144 | 20,138 |
Cash flows from investing activities: | ||
Purchase of Acacia, net of cash acquired | (74,153) | 0 |
Purchase of equity investment security and options | (12,500) | 0 |
Purchase of property and equipment | (168) | (274) |
Purchase of convertible promissory note | 0 | (5,000) |
Net cash used in investing activities | (86,821) | (5,274) |
Cash flows from financing activities: | ||
Proceeds from common stock option exercises | 1,747 | 1,841 |
Proceeds from lines of credit | 15,000 | 0 |
Employee withholding taxes related to stock-based awards | (1,341) | (1,551) |
Payment of debt | (6,000) | (6,000) |
Repurchases of common stock | (18,004) | (12,568) |
Net cash used in financing activities | (8,598) | (18,278) |
Net decrease in cash and cash equivalents | (82,275) | (3,414) |
Cash and cash equivalents at beginning of period | 97,659 | 103,155 |
Cash and cash equivalents at end of period | 15,384 | 99,741 |
Cash paid during the period for: | ||
Income taxes | 18,855 | 6,303 |
Interest | $ 894 | $ 917 |
Basis of Presentation and Other
Basis of Presentation and Other Company Information | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Other Company Information | Basis of Presentation and Other Company Information The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for reporting quarterly information. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. The condensed consolidated balance sheet at December 31, 2021 was derived from audited financial statements, but certain information and footnote disclosures normally included in our annual consolidated financial statements have been condensed or omitted. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the financial information for the interim periods reported have been made. Results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results for the year ending December 31, 2022 or any period thereafter. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 8, 2022. We are an integrated pharmaceutical company focused on finding ways to help medicines do more for patients. We and our collaborators have the capabilities to take a molecule from preclinical research through regulatory approval and into the marketplace, including development, manufacturing and commercialization. Our business model applies our scientific expertise, proprietary research-based insights and marketplace proficiency to identify challenging-to-treat diseases of the central nervous system or metabolic critical care therapeutic areas as well as in oncology. By focusing on patients' unmet needs, we strive to provide healthcare professionals with urgently needed treatment solutions that are designed to improve patient care and outcomes and create near- and long-term value for our stakeholders, including patients and healthcare providers and our employees, marketing partners, collaborators and investors. Our science-based business model has a proven track record with the U.S. Food and Drug Administration ("FDA") approval and commercial launches of six products: PEMFEXY® (pemetrexed for injection), vasopressin, an A-rated generic alternative to Vasostrict®, Ryanodex® (dantrolene sodium) ("Ryanodex"), bendamustine ready-to-dilute ("RTD") 500ml solution ("Belrapzo"), and rapidly infused bendamustine RTD ("Bendeka") and RTD (“Treakisym”). We market our products through marketing partners and/or our internal direct sales force. We market PEMFEXY, vasopressin, Ryanodex and Belrapzo, and Teva Pharmaceutical Industries Ltd. ("Teva") markets Bendeka through its subsidiary Cephalon, Inc. SymBio Pharmaceuticals Limited ("SymBio"), markets Treakisym, a RTD product, in Japan. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Significant Accounting Policies Our significant accounting policies are described in the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 and the notes thereto filed with the SEC on March 8, 2022. Since the date of those consolidated financial statements, there have been no material changes to our significant accounting policies other than as listed below. Business combinations and asset acquisitions - The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs, process, and output, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”) Accounting Standards Update ("ASU") 2017-01, “Business Combinations”, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including any contingent assets and liabilities, and any non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with Accounting Standards Codification (“ASC”) 805 - Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, would be recognized as a gain or loss and recorded condensed consolidated statement of operations. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50 Business Combinations – Related Issues, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s financial statements. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Significant Risks and Uncertainties In response to the ongoing COVID-19 pandemic, we have taken and continue to take active measures designed to address and mitigate the impact of the COVID-19 pandemic on our business, such as remote working policies, facilitating management’s periodic communication to address employee and business concerns and providing frequent updates to our Board of Directors (“Board”). We antic ipate that the COVID-19 pandemic may also have an impact on the clinical development timelines for certain of our clinical programs. We also anticipate that the COVID-19 pandemic may have an impact on our supply chain. The COVID-19 pandemic and associated lockdowns have resulted in a decrease in healthcare utilization broadly and specifically lead to a continuing reduction in the utilization of physician-administered oncology products including Belrapzo and Bendeka. In addition, the COVID-19 pandemic has delayed the timing of certain litigation and we anticipate that such delays will continue for the duration of the pandemic. The e xtent to which the COVID-19 pandemic will continue to impact our business, clinical development and regulatory efforts, supply chain and sales efforts, corporate development objectives and the value of, and market for, our common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. The global economic slowdown, the overall disruption of global healthcare systems, including rising inflation and interest rates, volatility in the markets and other risks and uncertainties associated with the pandemic have impacted our operations and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In addition, the U.S. government and other nations have imposed significant restrictions on most companies' ability to do business in Russia as a result of the ongoing military conflict between Russia and Ukraine. It is not possible to predict the broader or longer-term consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, security conditions, currency exchange rates and financial markets. Such geopolitical instability and uncertainty could have a negative impact on our ability to further expand our business and to otherwise generate revenues and develop our product candidates. In addition, a significant escalation or expansion of economic disruption or the conflict's current scope could have a material adverse effect on our business, financial condition, results of operations and growth prospects. We may opportunistically seek access to additional capital to fund potential licenses, acquisitions or investments to expand our operations or for general corporate purposes. Raising additional capital could be accomplished through one or more public or private debt or equity financings, collaborations or partnering arrangements. As a result of the COVID-19 pandemic, as well as the ongoing military conflict between Russia and Ukraine and the related sanctions imposed against Russia, and countermeasures related thereto in addition to macroeconomic conditions including rising inflation, the global credit and financial markets have experienced significant volatility and disruption. If these market conditions persist and deepen, we could experience an inability to access additional capital or our liquidity could otherwise be impacted, which could in the future negatively affect our capacity for certain corporate development transactions or our ability to make other important, opportunistic investments or acquisitions. An inability to borrow or raise additional capital in a timely manner and on attractive terms could prevent us from expanding our business or taking advantage of acquisition opportunities, and could otherwise have a material adverse effect on our business and growth prospects. In addition, if we use a substantial amount of our funds for any such potential acquisition or investment activities, we may not have sufficient additional funds to conduct all of our operations in the manner we would otherwise choose. Furthermore, any equity financing would be dilutive to our shareholders, and any financing could require the consent of the lenders under our credit facility. We are subject to other challenges and risks specific to our business and our ability to execute on our business plan and strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with research and development operations, including, without limitation, risks and uncertainties associated with: delays or problems in obtaining clinical supply; obtaining regulatory approval of product candidates; loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing intellectual property rights; and the challenges of complying with applicable regulatory requirements. In addition, as the ongoing COVID-19 pandemic, geopolitical and macroeconomic conditions affect our business and results of operations, they may also have the effect of heightening many of the other risks and uncertainties discussed above. Use of Estimates These condensed consolidated financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements including disclosure of gross to net estimates as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. Our critical accounting policies are those that are both most important to our financial condition and results of operations and also 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 uncertai n. We anticipate that the COVID-19 pandemic will continue to disrupt our supply chain and marketing and sales efforts for certain of our products, although it is not currently expected that any disruption would be significant. As of the date of issuance of these condensed consolidated financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the condensed consolidated financial statements, actual results may materially vary from these estimates, and any such differences may be material to our condensed consolidated financial statements. Cash and Cash Equivalents We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. We, at times, maintain balances with financial institutions in excess of the Federal Deposit Insurance Corporation (“FDIC”) limit. Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. Financial assets and liabilities measured and recognized at fair value are as follows: September 30, 2022 Total Level 1 Level 2 Level 3 Assets: Investment in Syros Pharmaceuticals, Inc. ("Syros") $ 2,882 $ 2,882 $ — $ — Investment in Enalare Therapeutics, Inc. 8,438 — — 8,438 Acquisition rights of Enalare Therapeutics, Inc. 8,125 — — 8,125 Liability: Forward Liability 4,063 — — 4,063 December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Tyme 6,030 6,030 — — We recognize transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three and nine months ended September 30, 2022. Our investment in Enalare Therapeutics Inc., related acquisition right and forward liability were classified as Level 3. We analyzed and accessed the contractual obligation to invest another $12.5 million within six months from August 2022, along with the purchase option included within the Securities Purchase Agreement (“SPA”). We used a probability factor to value the asset related to the acquired acquisition rights based on management's best estimate, including the probability of completion of certain development milestones. The equity stake was accounted for as non-readily determinable fair value (“RDFV”) investment. The equity investment and acquisition right was reported at fair value as of September 30, 2022. Refer to Note 15, Investment in Enalare Therapeutics Inc. for further information. Our investment in restricted shares of common stock of Syros Pharmaceuticals, Inc. ("Syros"), following the merger of Tyme Technologies, Inc. (“Tyme”) and Syros on September 16, 2022, are classified as Level 1. Refer to Note 12, License and Collaboration Agreements for further details. As of December 31, 2021, our investment in the convertible promissory note and the embedded derivative were classified as Level 3. We analyzed and accessed the embedded derivative feature contained in the convertible promissory note agreement. We used a probability factor to value the embedded derivative asset based on management's best estimate, including the principal and estimated accrued interest among other contractual terms. The convertible promissory note was accounted for as available for sale. The convertible promissory note was reported at fair value with unrealized gains and losses included in Accumulated other comprehensive income (loss). Refer to Note 13, Convertible Promissory Note for further details. In the first quarter of 2022, we entered into a forward contract to purchase euros at a forward rate. The contract settled in the second quarter of 2022 and was used to economically hedge the cost of the acquisition of Acacia. In second quarter of 2022, we entered into an additional forward contract to purchase euros at a forward rate. The contract was net settled in the third quarter of 2022 and was used to economically hedge the euro-dominated debt of Acacia that we assumed in connection with our acquisition all of the outstanding share capital of Acacia in June 2022. For the three and nine months ended September 30, 2022, the fair value adjustment on the forward contract was a loss of $0.7 million and a loss of $6.3 million, respectively, and the adjustments were recorded in Other (expense) income on our condensed consolidated statement of operations. The fair value of the previously existing legacy term loan is classified as Level 2 for the periods presented and approximates its book value due to the variable interest rate. The fair value of the euro-denominated loan that we assumed as part of our acquisition of Acacia is classified as Level 2 and was recorded on the balance sheet at fair value upon acquisition. Refer to Note 14. Business Acquisition for details regarding fair value measurements in connection with our acquisition of Acacia, including the fair value of the euro denominated loan. Intangible Assets We review the recoverability of our finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, we measure the amount of the impairment by comparing to the carrying value of the assets to the fair value of the assets. We determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed as of September 30, 2022. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics and Acacia acquisitions. Goodwill is not amortized, but is evaluated for impairment on an annual basis, in the fourth quarter, or more frequently if events or changes in circumstances indicate that the reporting unit’s goodwill is less than its carrying amount. We did not identify any impairment to goodwill during the periods presented. Concentration of Major Customers and Vendors The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's 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. The Company does not currently have a material allowance for collectible trade receivables. Further, 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 on our balance sheet, 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: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Total revenues Teva - See Revenue Recognition 39 % 69 % 32 % 66 % Customer A 8 % 1 % 16 % 6 % Customer B 15 % 9 % 13 % 8 % Customer C 14 % 3 % 13 % 4 % Customer D 10 % 11 % 9 % 10 % Other 14 % 7 % 17 % 6 % 100 % 100 % 100 % 100 % September 30, December 31, 2022 2021 Accounts receivable Teva - See Revenue Recognition 27 % 63 % Customer A 24 % 13 % Customer B 16 % 13 % Customer C 7 % 2 % Customer D 6 % 2 % Other 20 % 7 % 100 % 100 % Inventories Inventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. We periodically review the composition of inventory in order to identify obsolete, slow-moving or otherwise non-saleable items. If these items are observed and there are no alternate uses for the inventory, we will record a write-down to lower of cost and net realizable value in the period that the decline in value is first recognized. Research and Development Expense Costs for research and development are charged to expense as incurred and include; employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities, costs associated with regulatory operations; and depreciation expense for assets used in research and development activities. Costs for certain development activities, such as in licensing intellectual property related to new projects, clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the condensed consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $1.7 million and $0.5 million for the three months ended September 30, 2022 and 2021, respectively, and $5.1 million and $1.3 million for the nine months ended September 30, 2022 and 2021, respectively. Income Taxes We account for income taxes using the liability method in accordance with ASC 740 - Income Taxes (“ASC 740”). Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income (loss) in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. ASC 740 also prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that a company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606 - Revenue from Contracts with Customers ("ASC 606"), 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 purchases of product launch quantities. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price generally utilizing the expected value method to which the Company expects to be entitled. As such, revenue on sales to end users for vasopressin, Pemfexy, Belrapzo, Ryanodex, Barhemsys, and Byfavo are recorded net of chargebacks, rebates, returns, prompt pay discounts, wholesaler fees and other deductions. Our products are contracted with a limited number of oncology distributors and hospital buying groups with narrow differences in ultimate realized contract prices used to estimate our allowance for chargebacks and rebate reserves. The Company has a product returns policy on some of its products that allows the customer to return pharmaceutical products within a specified period of time both prior to and subsequent to the product’s expiration date. The Company's estimate of the provision for returns is analyzed quarterly and is based upon many factors, including historical experience of actual returns and analysis of the level of inventory in the distribution channel, if any. The Company has terms on sales of Ryanodex by which the Company does not accept returns. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made generally using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company believes that the estimates it has established are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. Components of Gross-to-Net (GTN) Estimates Chargebacks : Chargebacks are discounts that occur when certain contracted customers, including group purchasing organizations (“GPOs”), public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase from the Company's distributors. The Company's distributors purchase product from us at invoice price, then resell the product to certain contracted customers on the basis of prices negotiated between us and the providers. The difference between the distributors’ purchase price and the typically lower certain contracted customers’ purchase price is refunded to the distributors through a chargeback credit. We record estimates for these chargebacks at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances. The provision for chargebacks is the most significant provision in the context of the Company’s gross-to-net adjustments in the determination of net revenue. Chargebacks are estimated based on payer mix and contracted price, adjusted for current period assumptions. Commercial and Medicaid Rebates : The Company contracts with government agencies or collectively, third-party payors, so that vasopressin, Pemfexy, Belrapzo, Ryanodex, Barhemsys, and Byfavo will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payer mix, and (iv) information obtained from the Company’s distributors. The information that the Company also considers when establishing its rebate reserves are purchases by customers, projected annual sales for customers, actual rebates payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its largest distributors for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : The Company's provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. The Company’s distributors have the right to return unopened unprescribed vasopressin, Pemfexy, Belrapzo, Barhemsys, and Byfavo during certain time periods around the period beginning prior to the labeled expiration date and ending after the labeled expiration date. The Company estimates future product returns on sales of vasopressin, Pemfexy, Belrapzo, Barhemsys, and Byfavo based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iii) historical industry information regarding return rates for similar pharmaceutical products, (iv) the estimated remaining shelf life of vasopressin, Pemfexy, Belrapzo, Barhemsys, and Byfavo previously shipped and currently being shipped to distributors and (v) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrue |
Property and Equipment, net
Property and Equipment, net | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment consisted of the following: September 30, 2022 December 31, 2021 Estimated Useful Life (years) Furniture and fixtures $ 1,525 $ 1,525 7 Office equipment 1,077 1,077 3 Equipment 4,003 3,834 7 Leasehold improvements 1,155 1,155 2 7,760 7,591 Less accumulated depreciation (6,463) (5,955) Property and equipment, net $ 1,297 $ 1,636 |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: September 30, December 31, 2022 2021 Raw materials (1) $ 9,704 $ 7,317 Work in process (2) 21,246 9,666 Finished products (3) 32,905 4,925 Total inventories $ 63,855 $ 21,908 (1) $1.7 million of Raw materials represents inventory acquired with Acacia as detailed in Note 14. (2) $2.9 million of Work in process represents inventory acquired with Acacia as detailed in Note 14. (3) $21.8 million of Finished products represents inventory acquired with Acacia as detailed in Note 14. |
Balance Sheet Accounts
Balance Sheet Accounts | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: September 30, December 31, 2022 2021 Prepaid income taxes $ 566 $ 1,173 Prepaid FDA user fee and advances to clinical research organization — 1,108 Prepaid insurance 537 196 Advances to commercial manufacturers 3,164 2,354 Prepaid R&D 1,445 — Convertible promissory note, net — 5,312 Other receivable related to cost sharing arrangement with commercial partner 998 347 All other 2,165 1,400 Total prepaid expenses and other current assets $ 8,875 $ 11,890 Accrued Expenses Accrued expenses consist of the following: September 30, December 31, 2022 2021 Accrued product sales reserves $ 21,662 $ 4,390 Income taxes payable 5,750 — Royalties payable to commercial partners 9,724 5,085 Accrued salary and other compensation 3,702 8,466 Accrued professional fees 7,622 2,013 Accrued research & development 4,233 4,100 Current portion of lease liability 1,508 1,309 Inventory received but not invoiced 14,431 6,177 Forward liability 4,063 — Accrued other 957 798 Total accrued expenses $ 73,652 $ 32,338 Leases We lease office space in Woodcliff Lake, New Jersey for our principal office under an amended lease agreement through June 2025. We also lease a lab space in Cambridge, Massachusetts under a lease agreement through April 2024, office space located in Indianapolis, Indiana through November 2023, and an office space located in Palm Beach Gardens, Florida. All of our leases are classified as operating leases and have remaining lease terms of approximately 2.3 years. The principal office and the lab space leases include renewal options to extend the lease for up to 5 years. Furthermore, we have not elected the practical expedient to separate lease and non-lease components for all classes of underlying assets. The table below summarizes our total lease costs included in the condensed consolidated financial statements, as well as other required quantitative disclosures (in thousands): September 30, 2022 December 31, 2021 Operating lease cost $ 1,173 $ 1,407 Total lease cost $ 1,173 $ 1,407 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 1,173 $ 1,407 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 270 Weighted-average remaining lease term - operating leases 2.3 years 3.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % Balance Sheet Classification as of September 30, 2022: Current lease liabilities (included with Accrued expenses and other liabilities) $ 1,508 Long-term lease liabilities (included with Other long-term liabilities) 1,874 Total lease liabilities $ 3,382 |
Intangible Assets, Net
Intangible Assets, Net | 9 Months Ended |
Sep. 30, 2022 | |
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: September 30, 2022 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Barhemsys intangible (1) 9 $ 68,000 $ (2,425) $ 65,575 Byfavo intangible (1) 9 36,000 (1,193) 34,807 Ryanodex intangible (2) 9 15,000 (6,821) 8,179 Vasopressin milestone (3) 1 750 (526) 224 Total $ 119,750 $ (10,965) $ 108,785 December 31, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Ryanodex intangible (2) 9 $ 15,000 $ (5,079) $ 9,921 Developed technology 5 8,100 (8,100) — Vasopressin milestone (3) 1 750 — 750 Total $ 23,850 $ (13,179) $ 10,671 (1) Represents intangible assets acquired in the Acacia acquisition as detailed in Note 14. (2) Represents a one-time payment made to reduce the royalties payable to a third party on Ryanodex net sales. (3) Represents milestone paid to a third party upon FDA approval of vasopressin. Amortization expense was $3.7 million and $0.7 million for the three months ended September 30, 2022 and 2021, respectively and $5.9 million and $2.1 million for the nine months ended September 30, 2022 and 2021, respectively. Estimated Amortization Expense for Intangible Assets Based on definite-lived intangible assets recorded as of September 30, 2022, and assuming that the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2022 (remainder) 3,690 2023 14,405 2024 14,127 2025 13,886 2026 11,584 Thereafter 51,093 Total estimated amortization expense $ 108,785 |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Common Stock and Stock-Based Compensation | Common Stock and Stock-Based Compensation Common Stock Share Repurchase Program In March 2020, our board of directors approved our current share repurchase program (the "Share Repurchase Program"), providing for the repurchase of up to an aggregate of $160 million of our outstanding common stock. Under the Share Repurchase Program, we are authorized to repurchase shares through open market purchases, privately-negotiated transactions, accelerated share repurchases or otherwise in accordance with applicable federal securities laws, including through Rule 10b5-1 trading plans and under Rule 10b-18 of the Exchange Act. The repurchases have no time limit and may be suspended or discontinued completely at any time. The specific timing and amount of repurchases will vary based on available capital resources and other financial and operational performance, market conditions, securities law limitations, and other factors. The repurchases will be made using our cash resources. On September 23, 2020, our Board of Directors approved a $25 million accelerated share repurchase (“ASR”) transaction with JPMorgan Chase Bank, National Association (“JP Morgan”) as part of our existing $160 million share repurchase program. The specific number of shares to be repurchased pursuant to the ASR is based on the average of the daily volume weighted average share prices of our common stock, less a discount, during the term of the ASR program. Under the terms of our agreement with JP Morgan, we paid $25 million to JP Morgan on September 24, 2020, and received 550,623 shares, representing the notional amount of the ASR, based on the average of the daily volume weighted average share prices of our common stock, less a discount, during the term of the ASR, which was $45.40. The ASR was completed in the fourth quarter of 2020. We determined the ASR contained a forward contract and therefore we recorded fair value adjustments on the accelerated share repurchase agreement in the amount of $3 million which was a loss recorded in Other expense on our consolidated statements of operations in the year ended December 31, 2020. As of September 30, 2022, we had repurchased an aggregate of 4,552,730 shares of common stock for an aggregate of $246.1 million pursuant to our share repurchase programs in effect since August 2016. Stock-Based Compensation In November 2013, our Board of Directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2014 Plan provides for the awards of incentive stock options, non-qualified stock options, restricted stock, restricted stock units and other stock-based awards. Awards generally vest equally over a period of four years from grant date. Vesting may be accelerated under a change in control of the Company or in the event of death or disability to the recipient. In the event of termination, any unvested shares or options are forfeited. In 2018, we introduced a new long-term incentive program with the objective to better align the stock-based awards granted to management with our focus on improving total shareholder return over the long-term. The stock-based awards granted under this long-term incentive program consist of time-based stock options, time-based RSUs and PSUs. PSUs are comprised of awards: i) that would have vested upon achievement of certain share price appreciation conditions or ii) that would have vested upon achievement of certain milestone events. A summary of stock option, RSU and PSU activity under the 2014 Plan during the nine months ended September 30, 2022 and 2021 is presented below: Stock Options RSUs PSUs Outstanding as of December 31, 2020 3,331,890 328,396 97,750 Granted 109,000 106,600 159,000 Stock options exercised/RSUs vested/PSUs vested (100,477) (94,273) — Forfeited or expired (308,815) (46,941) (97,750) Outstanding as of September 30, 2021 3,031,598 293,782 159,000 Outstanding as of December 31, 2021 2,814,878 263,306 137,300 Granted 123,700 148,000 228,200 Stock options exercised/RSUs vested/PSUs vested (91,255) (101,898) — Forfeited or expired (73,983) (36,616) (46,400) Outstanding as of September 30, 2022 2,773,340 272,792 319,100 Stock Options The fair value of stock options granted to employees, directors, and consultants were estimated using the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Risk-free interest rate 2.83% - 3.66% 0.82% - 0.93% 1.47% - 3.66% 0.51% - 1.12% Volatility 46.69% 54.92% 46.83% 56.07% Expected term (in years) 6.08 years 6.08 years 5.76 years 5.68 years Expected dividend yield 0.0% 0.0% 0.0% 0.0% RSUs Each vested time-based RSU represents the right of a holder to receive one share of our common stock. The fair value of each RSU granted was estimated based on the trading price of our common stock on the date of grant. PSUs During the first quarter of 2022, we granted 228.2 thousand market condition PSUs based on our total shareholder return ("TSR") relative to the TSR of each member of the S&P Biotechnology Select Industry Index (the defined peer group) with a weighted-average grant date fair value of $70.45 for the CEO and $53.43 for other executives per respective PSU. The fair value of PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation include a risk-free interest rate of 1.6%, an expected volatility of 41%, contractual term of 3 years, and no expected dividend yield. The fair value of market condition PSUs granted to employees was estimated using a Monte Carlo simulation model. Inputs used in the calculation are described above. The fair value of performance condition PSUs granted to employees was estimated based on the trading price of our common stock on the date of grant adjusted for probability of achievement of the performance conditions as described above. We did not recognize any expense for performance based PSUs granted to employees based on our estimated probability of achievement as described above. We recognized stock-based compensation in our condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options $ 1,597 $ 2,515 $ 5,131 $ 8,393 RSUs 989 1,046 3,913 4,051 PSUs 951 523 3,288 2,429 Stock-based compensation expense $ 3,537 $ 4,084 $ 12,332 $ 14,873 Selling, general and administrative $ 2,937 $ 3,443 $ 10,488 $ 12,696 Research and development 600 641 1,844 2,177 Stock-based compensation expense $ 3,537 $ 4,084 $ 12,332 $ 14,873 |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Our future material contractual obligations as of September 30, 2022, included the following: Obligations Total 2022 2023 2024 2025 Beyond Operating leases (1) $ 3,621 $ 414 $ 1,672 $ 1,122 $ 413 $ — Credit facility and Term Loans (2) 59,324 35,000 4,257 12,162 7,905 — Investment in Enalare (4) 12,500 — 12,500 — — — Purchase obligations (3) 99,403 99,403 — — — — Total obligations $ 174,848 $ 134,817 $ 18,429 $ 13,284 $ 8,318 $ — (1) We lease our corporate office location. The term of our existing lease expires on June 30, 2025. We also lease our lab space under a lease agreement through April 2024, office space located in Indianapolis, Indiana through November 2023, and an office space in Palm Beach Gardens, Florida, through October 31, 2024. Rental expense for the operating leases was $0.4 million and $0.3 million, for the three months ended September 30, 2022 and 2021, respectively. Rental expense for the operating leases was $1.2 million and $1.0 million for the nine months ended September 30, 2022 and 2021.The remaining future lease payments under the operating leases are $3.6 million as of September 30, 2022. (2) Refer to Note 9, “Debt” for further information regarding our Credit Agreement and Term Loans. (3) As of September 30, 2022, we had purchase obligations in the amount of $99.4 million which represents the contractual commitments under contract manufacturing and supply agreements with suppliers. The obligations under the supply agreements are primarily for finished product, inventory, and research and development. (4) We invested $12.5 million in Enalare at the time of entering the agreement in August 2022, and we are contractually obligated to invest another $12.5 million six months after August 2022. Refer to Note 15 for further details. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt As of June 9, 2022, upon closing of our acquisition of Acacia, we guaranteed a term loan facility, dated as of January 10, 2020, by and between Acacia Pharma Limited (“APL”), a direct subsidiary of Acacia, and Cosmo Technologies Ltd. (the “Term Loan Facility”). The Term Loan Facility provides for up to €25 million in loans, all of which was drawn as of closing of the acquisition. See Note 14 Business Acquisition for further information on our acquisition of Acacia. These borrowings were drawn in two tranches; Tranche A for a €15 million term loan with periodic payments through July 31, 2025; and Tranche B for a €10 million term loan with periodic payments through September 30, 2025. Each tranche bears an annual interest rate of 9%. The guarantee provides that we shall guarantee the punctual performance by APL of APL’s obligations pursuant to the terms of the Term Loan Facility (as amended) and that we will immediately on demand pay any amount owed by APL under the Term Loan Facility (as amended) as if we were the principal obligor in the event that such amount is not paid by APL On November 8, 2019, we entered into the Second Amended and Restated Credit Agreement (the “Prior Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative agent (the “Administrative Agent”) and the lenders party thereto. The terms and amounts borrowed under the Prior Credit Agreement includes a drawn term loan of $40 million and a revolving credit facility of $110 million. The schedule of principal payments for the new term loan facility was extended to November 8, 2022. During the third quarter of 2022, we drew down $15 million from our revolving credit facility under the Credit Agreement. We classified debt related to the pre-existing term loan and revolving credit facility of $35 million as current on our condensed consolidated balance sheet as of September 30, 2022. Per the terms of the Prior Credit Agreement and the Amended and Restated Credit Agreement (as defined herein), we are limited in our ability to pay dividends. As of September 30, 2022, we were in compliance with each of the senior secured net leverage ratio; total net leverage ratio; and fixed charge coverage ratio covenants. On November 1, 2022, we entered into the Third Amended and Restated Credit Agreement (the “Third Amended Credit Agreement”) with the Administrative Agent and the lenders party thereto, which replaced the Prior Credit Agreement. The terms and amounts borrowed under the Third Amended Credit Agreement includes a drawn term loan of $50 million and a $100 million revolving credit facility of which $15 million was drawn on November 1, 2022. The new maturity date of the schedule of principal payments for each of the revolving credit facility and the term loan facility is October 31, 2025, unless required to mature earlier or extended pursuant to the terms of the Third Amended Credit Agreement. Refer to Note 16, Subsequent Events, for further details on the Third Amended Credit Agreement. The term loan facility under the Prior Credit Agreement bore 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. Loans under the Prior Credit Agreement bore 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 Prior Credit Agreement), or (b) the Benchmark Replacement which is defined as the greatest of the prime lending rate, or the NYFRB Rate (the rate for a federal funds transaction) in effect on such day plus ½ of 1% or the Adjusted LIBO Rate for a one month Interest Period on such day plus 1% plus an applicable margin ranging from 1.25% to 2.0% per annum, based upon the total net leverage ratio. We were required to pay a commitment fee on the unused portion of the new revolving credit facility in the Prior Credit Agreement at a rate ranging from 0.35% to 0.45% per annum based upon the total net leverage ratio. As of September 30, 2022, we had $0.1 million of unamortized deferred debt issuance costs as part of current debt in our condensed consolidated balance sheets. Debt Maturities As of September 30, 2022 2022 (remainder) $ 35,000 2023 4,257 2024 12,162 2025 7,905 Total $ 59,324 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Income tax (provision) benefit $ (3,468) $ 7,038 $ (20,652) $ 3,341 Effective tax rate (95) % 56 % 43 % 58 % For interim periods, we recognize an income tax provision based on our estimated annual effective tax rate expected for the entire year plus the effects of certain discrete items occurring in the quarter. The interim annual estimated effective tax rate is based on the statutory tax rates then in effect, as adjusted for changes in estimated permanent differences, and certain discrete items whose tax effect, when material, is recognized in the interim period in which they occur. The effective tax rate for the three and nine months ended September 30, 2022,reflects an interim tax provision resulting from impact of certain non-deductible executive compensation and the impact of the acquisition of Acacia and of certain non-deductible cost from the acquisition of Acacia, partially offset by credits for research and development activity. The effective tax rate for the three and nine months ended September 30, 2021, reflects the impact of certain non-deductible executive compensation and expired stock compensation, partially offset by credits for research and development activity and excess tax deduction we can realize for our stock based awards. We review the realizability of our deferred tax assets on a quarterly basis, or whenever events or changes in circumstances indicate that a review is required. In determining the requirement for a valuation allowance, the historical and projected financial results of the legal entity or consolidated group recording the net deferred tax asset are considered, along with any other positive or negative evidence. Since future financial results, including the fair value adjustment on our investment in Syros may differ from previous estimates, periodic adjustments to our valuation allowances may be necessary. Deferred income tax assets as of September 30, 2022 consisted of temporary differences primarily related to the net operating losses of Acacia, stock-based compensation and research and development tax credit carryforwards, partially offset by temporary differences related to intangible assets and research and development expenses. We file income tax returns in the U.S. federal jurisdiction and several states. We are currently under audit by the Internal Revenue Service (IRS) and three State tax jurisdictions. We had no amount recorded for any unrecognized tax benefits as of September 30, 2022. We regularly evaluate our tax positions for additional unrecognized tax benefits and associated interest and penalties, if applicable. There are many factors that are considered when evaluating these tax positions including: interpretation of tax laws, recent tax litigation on a position, past audit or examination history, and subjective estimates and assumptions. We reflect interest and penalties attributable to income taxes, to the extent they arise, as a component of income tax provision or benefit. |
Legal Proceedings
Legal Proceedings | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal Proceedings In addition to the below legal proceedings, from time to time, we may be a party to litigation and subject to claims incident to the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters, or matters discussed below, will not have a material adverse effect on our business nor have we recorded any loss in connection with these matters because we believe that loss is neither probable nor estimable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. In Re: Taxotere (Docetaxel) Beginning in May 2022, 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 3023 (Civil Action No 22-1347 H(5)), or the Multidistrict Litigation. The claims are for personal injuries allegedly arising out of the use of docetaxel. Patent Litigation Eagle Pharmaceuticals, Inc., et al. v. Slayback Pharma Limited Liability Company; Eagle Pharmaceuticals, Inc., et al. v. Apotex Inc. and Apotex Corp.; Eagle Pharmaceuticals, Inc., et al. v. Fresenius Kabi USA, LLC; Eagle Pharmaceuticals, Inc., et al. v. Mylan Laboratories Limited; Eagle Pharmaceuticals, Inc. et al. v. Hospira, Inc; Eagle Pharmaceuticals, Inc. et al. v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc.; Teva Pharmaceuticals Int’l GmbH et al v. Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., and Eugia Pharma Specialities Ltd.; Teva Pharmaceuticals Int’l GmbH et al v. Accord Healthcare Inc., Accord Healthcare Ltd., and Intas Pharmaceuticals Ltd.; Teva Pharmaceuticals Int’l GmbH et al v. Dr. Reddy’s Laboratories, Ltd., and Dr. Reddy’s Laboratories, Inc. - (Bendeka ® ) Bendeka, which contains bendamustine hydrochloride, is an alkylating drug that is indicated for the treatment of patients with chronic lymphocytic leukemia, as well as for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Slayback Pharma Limited Liability Company (“Slayback”), Apotex Inc. and Apotex Corp. (“Apotex”), Fresenius Kabi USA, LLC (“Fresenius”), Mylan Laboratories Limited (“Mylan”), Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”), and Aurobindo Pharma, Ltd, Aurobindo Pharma USA, Inc., and Eugia Pharma Specialities Ltd (“Aurobindo”) have filed Abbreviated New Drug Applications (“ANDA’s”) referencing Bendeka ® that include challenges to one or more of the Bendeka ® Orange Book-listed patents. Hospira, Inc. (“Hospira”) filed a 505(b)(2) NDA. We, Cephalon, Inc. and/or Teva Pharmaceuticals International GMBH (together the “Patentees”), filed separate suits against Slayback, Apotex, Fresenius, Mylan, Hospira, Lupin, and Aurobindo in the United States District Court for the District of Delaware on August 16, 2017 (Slayback (“Slayback I”)), August 18, 2017 (Apotex), August 24, 2017 (Fresenius), December 12, 2017 (Mylan), January 19, 2018 (Slayback (“Slayback II”)), July 19, 2018 (Hospira), and July 2, 2019 (Lupin) and May 11, 2020 (Aurobindo). In these Complaints, the Patentees allege infringement of the challenged patents, namely U.S. Patent Nos. 8,791,270 and 9,572,887 against Slayback (Slayback I and Slayback II), and of U.S. Patent Nos. 8,609,707, 8,791,270, 9,000,021, 9,034,908, 9,144,568, 9,265,831, 9,572,796, 9,572,797, 9,572,887, 9,579,384, 9,597,397, 9,597,398, 9,597,399 against Fresenius, Apotex, and Mylan, and of U.S. Patent Nos. 9,572,887, 10,010,533, 9,034,908, 9,144,568, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384 against Hospira, and of U.S. Patent Nos. 8,609,707, 9,000,021, 9,034,908, 9,144,568, 9,265,831, 9,572,796, 9,572,797, 9,572,887, 9,579,384, 9,597,397, 9,597,398, 9,597,399, 10,010,533, and 10,052,385 against Lupin and of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385 against Aurobindo. The parties stipulated to dismiss without prejudice U.S. Patent No. 8,791,270 as to Apotex, Fresenius and Mylan on July 24, 2018, August 2, 2018, and August 3, 2018, respectively. Slayback, Apotex, Fresenius, and Mylan answered their Complaints and some filed various counterclaims on September 29, 2017 (Slayback I), February 12, 2018 (Slayback II), November 27, 2017, September 15, 2017, and February 14, 2018, respectively. The Patentees answered the Slayback I, Slayback II, Fresenius, and Apotex counterclaims on October 20, 2017, March 5, 2018, October 6, 2017, and December 18, 2017, respectively. On October 15, 2018, the Patentees filed a suit against Fresenius and Mylan in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 10,010,533 and 10,052,385. The Slayback I, Slayback II, Apotex, Fresenius and Mylan cases have been consolidated for all purposes (the “Consolidated Bendeka Litigation”), and a bench trial in these cases was held September 9-19, 2019. On April 27, 2020, the district court held that the asserted patents are valid and infringed by Slayback, Apotex, Fresenius and Mylan. On July 6, 2020, the district court entered a final judgment reflecting this decision, stating that pursuant to 35 U.S.C. § 271(e)(4)(A), the FDA shall not approve Apotex’s, Fresenius’s, Mylan’s, or Slayback’s ANDA products on a date which is earlier than January 28, 2031, and enjoining Apotex, Fresenius, Mylan, and Slayback from commercially manufacturing, using, offering to sell, or selling within the US or importing into the US, their ANDA products before that date. On August 4, 2020, Apotex, Fresenius, and Mylan appealed this final judgment, and filed their opening briefs on November 4, 2020. Plaintiffs’ responsive appeal brief was filed on February 12, 2021. Defendants’ reply briefs were filed April 5, 2021. On August 2, 2021, Fresenius’s appeal was dismissed pursuant to a settlement agreement reached with Patentees. Oral argument for the remaining defendants occurred on August 3, 2021. On August 13, 2021, the appeals court affirmed the trial court’s decision. The mandate was issued on October 22, 2021. Apotex filed a petition for certiorari on December 14, 2021, which the Supreme Court denied on February 22, 2022. Hospira filed a motion to dismiss, which was fully briefed on November 16, 2018. On December 16, 2019, the United States District Court for the District of Delaware denied Hospira’s motion to dismiss with respect to U.S. Patent No. 9,572,887 and granted that motion with respect to the remaining patents. On December 15, 2020, the Court held a claim construction hearing, ruling in our favor on all claim terms. Fact discovery closed on April 1, 2021. Expert discovery ended on February 10, 2022. The parties reached a settlement on April 19, 2022, resulting in dismissal of the action. Patentees filed suit against Hospira, Inc. on November 16, 2021. Patentees have asserted U.S. Patent No. 11,103,483. Hospira filed its Answer on December 8, 2021. The parties reached a settlement on April 19, 2022, resulting in dismissal of the action. On March 10, 2020, the parties filed a stipulation and order of dismissal without prejudice as to Lupin, which the Court entered March 11, 2020. Aurobindo answered the Complaint on July 20, 2020. The parties exchanged initial disclosures on December 11, 2020. Plaintiffs provided their infringement contentions on March 12, 2021. On October 20, 2021 the Court entered a stipulation of dismissal based on a settlement between the parties. Patentees filed suit against Dr. Reddy’s Laboratories on May 13, 2021. Patentees have asserted U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385. Dr. Reddy’s answer was filed August 16, 2021. On December 27, 2021, Dr. Reddy’s moved for judgment on the pleadings, seeking a dismissal of all patents except the ‘887 patent. On January 27, 2022, the Court entered an agreed stipulation by the parties dismissing all patents except the ‘887. On February 8, 2022, consistent with that stipulation, Patentees filed an Amended Complaint removing the dismissed patents and adding U.S. Patent No 11,103,483. Dr. Reddy’s filed its Answer and Counterclaims to that Amended Complaint on February 22, 2022. Patentees’ filed their Counterclaim Answer on March 15, 2022. Fact discovery is ongoing. A claim construction hearing was held on September 15, 2022, and the case is set for trial on May 1, 2023. Patentees filed suit against Accord Healthcare on June 29, 2021. Patentees have asserted U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797, 9,034,908, 9,144,568, 9,572,887, 9,597,397, 9,597,398, 9,597,399, 9,000,021, 9,579,384, 10,010,533, and 10,052,385. On January 13, 2022, Accord filed a Motion to Dismiss for failure to state a claim. On January 26, 2022, Patentees filed a First Amended Complaint, removing all patents except the ‘887 patent and additionally asserting U.S. Patent No. 11,103,483. Accord filed its Answer and Counterclaims to that Amended Complaint on February 10, 2022. On February 28, 2022, Patentees filed their Answer to Accord’s Counterclaims. On March 29, 2022, the Court entered a schedule and consolidated this case with the above Dr. Reddy’s case. Fact discovery is ongoing. A claim construction hearing was held on September 15, 2022, and the case is set for trial on May 1, 2023. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company - (Belrapzo®) Slayback filed an ANDA referencing Eagle's Belrapzo NDA. Slayback’s ANDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On September 20, 2018, the Company filed a suit against Slayback in the United States District Court for the District of Delaware, alleging patent infringement of U.S. Patent Nos. 8,609,707, 9,265,831, 9,572,796, 9,572,797 and 10,010,533. On October 10, 2018, Slayback answered the Complaint and filed various counterclaims. On October 31, 2018, the Company answered Slayback’s counterclaims. Pursuant to a stipulation between the parties, Slayback is bound by any final judgment entered in the Consolidated Bendeka Litigation. This case is currently stayed. Eagle Pharmaceuticals, Inc. v. Slayback Pharma Limited Liability Company, Apotex, Inc. and Apotex Corp., Celerity Pharmaceuticals, LLC - (Belrapzo ® ) Slayback, Apotex, and Celerity Pharmaceuticals, LLC (“Celerity”) filed NDAs referencing Eagle’s Belrapzo NDA. The Company filed suits against Slayback, Apotex, and Celerity in the United States District Court for the District of Delaware on August 31, 2021 (Slayback and Apotex) and on January 11, 2022 (Celerity) alleging infringement of U.S. Patent No. 11,103,483. On September 22, 2021, both Slayback and Apotex filed their Answers. On September 29, 2022, trial was held in the suit against Slayback and Apotex. On October 25, 2022, the Court issued its opinion and entered a judgment of non-infringement with respect to Slayback and Apotex. The Company filed a notice of appeal on October 26, 2022. On February 2, 2022, Celerity moved to dismiss the pending complaint. In response, the Company filed an Amended Complaint on March 1, 2022. Celerity filed its Answer to the Company’s Amended Complaint on March 22, 2022. On April 19, 2022, Celerity moved for judgment on the pleadings. Briefing on that motion is closed and a decision is pending. On June 24, 2022, the Court entered a schedule coordinated with the above Accord and Dr. Reddy’s cases. Fact discovery is ongoing. A claim construction hearing was held on September 15, 2022. On October 28, 2022, the parties filed a proposed stipulated judgment of non-infringement, which is pending entry by the Court. The case is set for trial on May 1, 2023. Eagle Pharmaceuticals, Inc. v. Accord Healthcare Inc., Accord Healthcare Ltd., and Intas Pharmaceuticals Ltd. - (Belrapzo ® ) Accord filed an NDA referencing Eagle's Belrapzo NDA. Accord’s NDA includes challenges to one or more of the Belrapzo Orange Book-listed patents. On May 27, 2022, the Company filed a suit against Accord 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, 10,010,533, and 11,103,483. On July 6, 2022 the Company filed a First Amended Complaint, removing all patents except the ‘483 patent. Accord filed its Answer and Counterclaims on July 20, 2022. The Company filed its Answer to Accord’s Counterclaims August 9, 2022. On September 20, 2022, the Court entered a schedule consolidating this case with the above Accord and Dr. Reddy’s cases. Fact discovery is ongoing. A claim construction hearing was held on September 15, 2022, and the case is set for trial on May 1, 2023. 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 is an alternative to Vasostrict, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. The Company answered the complaint on August 6, 2018, and filed an amended answer and counterclaims on October 30, 2019. The court issued a Markman ruling on July 1, 2019. On December 20, 2019, Par dismissed with prejudice claims of three of the patents asserted against Eagle, and the Court entered an Order reflecting that dismissal on December 27, 2019. Mediation took place on March 3, 2020. On April 17, 2020, we submitted a letter requesting leave to file a motion for summary judgment of non-infringement. Par’s responsive letter was submitted on May 8, 2020. On May 18, 2020, the court said it would hear non-infringement arguments at trial and not through summary judgment. Fact discovery ended in October 2019, and expert discovery ended in February 2020. Due to the COVID-19 pandemic, the trial, which was scheduled to begin May 18, 2020, was rescheduled to and occurred on July 7-9, 2021. Post-trial briefing was submitted on July 28, 2021. The Court issued an opinion on August 31, 2021 and entered a final judgment of non-infringement in favor of Eagle on September 16, 2021. Par filed a Notice of Appeal of the final judgment on September 22, 2021, and the appeal was docketed with the United States Court of Appeals for the Federal Circuit on September 23, 2021. Par filed its principal appeal brief on December 6, 2021, Eagle filed its responsive appeal brief on February 1, 2022, and Par filed its reply appeal brief on February 22, 2022. Oral argument occurred before the Federal Circuit on July 7, 2022. On August 18, 2022, the Federal Circuit affirmed the District Court’s finding of non-infringement, and on September 26, 2022, the Federal Circuit issued the formal mandate. The FDA approved Eagle’s ANDA on December 15, 2021. On December 16, 2021, Par filed an emergency motion for temporary restraining order and preliminary injunction in the district court to enjoin Eagle from launching its product, but Par voluntarily withdrew the motion on December 20, 2021. Eagle commercially launched its ANDA product in January 2022. The 30-month stay of FDA approval expired on October 17, 2020. On December 7, 2020, Par filed a separate suit against us in the United States District Court for the District of New Jersey, asserting patent infringement of U.S. Patent No. 10,844,435, based on the filing of our ANDA seeking approval to manufacture and sell our vasopressin product. Eagle moved to dismiss Par’s complaint on March 2, 2021. On March 22, 2021, Par amended |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements License agreement with Combioxin In August 2021, we entered into a license agreement with Combioxin, SA under which the Company was granted exclusive, worldwide development and commercialization rights to CAL02, a novel first-in-class anti-infective agent ready for Phase 2b/3 development for the treatment of severe pneumonia in combination with traditional antibacterial drugs. The Company will be solely responsible for the development, regulatory, manufacturing and commercialization activities of CAL02. Combioxin will assist the Company in transitioning the manufacturing and supply of CAL02 to the Company. Under the terms of the agreement, we paid $10 million as upfront license consideration that was expensed immediately as research and development and is reflected within the operating activities of the consolidated statements of cash flows as of December 31, 2021. The Company may pay to Combioxin up to $105 million upon achievement of certain development, regulatory and sales based milestone payments plus royalty payments at royalty rates ranging in low double digit percentages on the net sales of all products sold, subject to certain adjustments as provided in the agreement. The Company is also obligated to make certain payments based upon amounts received by sublicensees under the agreement. License agreement with AOP Orphan In August 2021, we entered into a licensing agreement with AOP Orphan Pharmaceuticals GmbH (“AOP Orphan”), a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to its product, landiolol in the United States. Landiolol, a leading hospital emergency use product, is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. We supported the submission of a new drug application (“NDA”) in the second quarter of 2022 by AOP Orphan to the FDA seeking approval for landiolol for the short term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”) , including atrial fibrillation and atrial flutter. Under the terms of the agreement, we paid a $5 million upfront license consideration that was expensed immediately as research and development and is reflected within the operating activities of the consolidated statements of cash flows as of December 31, 2021 . We may pay to AOP Orphan up to $25 million upon achievement of certain regulatory milestone payments plus profit share payments, subject to certain adjustments as provided in the agreement. We also entered into a supply agreement at the same time as the licensing agreement. Collaboration with Tyme (now merged with Syros) On January 7, 2020, Tyme Technologies, Inc. (“Tyme”) and we announced a strategic collaboration to advance SM-88, an oral product candidate for the treatment of patients with cancer. SM-88 is an investigational agent in two Phase II studies, one for pancreatic cancer and another for prostate cancer. In September 2022, Syros announced the closing of its merger with Tyme pursuant to which Syros acquired Tyme. The combined company will be known as Syros going forward. Under the terms of a related co-promotion agreement, we would be responsible for 25% of the promotional sales effort of SM-88 and would receive 15% royalty on the net revenues of SM-88 in the United States. Syros is responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. Syros retains the remaining 85% of net U.S. revenues and reserves the right to repurchase our U.S. co-promotion right for $200.0 million. |
Convertible Promissory Note
Convertible Promissory Note | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Convertible Promissory Note | Convertible Promissory Note During the first quarter of 2021, we invested $5 million in a convertible promissory note (the "note") of a privately held clinical-stage biotechnology company (the "issuer"). The note bears an 8% annual interest rate and has an 18-month term. The issuer is not required to make any principal or interest payments until the end of the term. The note, along with any accrued interest, may automatically convert into equity securities of the issuer under either a financing event or a change in control event as defined in the convertible promissory note agreement. The issuer's product development efforts could encounter technical or other difficulties that could increase their development costs more than expected. The issuer did not have sufficient cash and was unable to obtain additional capital to be able to repay the convertible promissory note with accrued interest at the end of the term. As of September 30, 2022, we impaired the note, accrued interest, as well as the value of the embedded derivative related to the equity conversion feature contained in the note. The following table summarizes the activity during the three months ended September 30, 2022; June 30, 2022 Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative September 30, 2022 Fair value of the note $ 5,510 $ (5,510) $ — $ — $ — $ — $ — Discount on the note (36) 36 — — — — — Estimated Credit Loss (820) — — 820 — — — Convertible Promissory Note, net $ 4,654 $ (5,474) $ — $ 820 $ — $ — $ — Embedded Derivative $ 1,026 $ — $ — $ — $ — $ (1,026) $ — Interest Receivable $ 530 $ — $ — $ (530) $ — $ — $ — Total in Other Current Assets $ 6,210 $ (5,474) $ — $ 290 $ — $ (1,026) $ — The following table summarizes the amounts recorded and activity during the nine months ended September 30, 2022; December 31, 2021 Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative September 30, 2022 Fair value of the note $ 4,906 $ (4,906) $ — $ — $ — $ — $ — Discount on the note (127) — 127 — — — — Estimated Credit Loss (758) — — 758 — — — Convertible Promissory Note, net $ 4,021 $ (4,906) $ 127 $ 758 $ — $ — $ — Embedded Derivative $ 962 $ — $ — $ — $ — $ (962) $ — Interest Receivable $ 329 $ — $ — $ (329) $ — $ — $ — Total in Other Current Assets $ 5,312 $ (4,906) $ 127 $ 429 $ — $ (962) $ — |
Business Acquisition
Business Acquisition | 9 Months Ended |
Sep. 30, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Business Acquisition | Business Acquisition On June 9, 2022, we completed our previously announced acquisition of the entire issued share capital of Acacia for cash consideration and common stock totaling 94.7 million euros, the equivalent of 0.90 euros per share, and an aggregate of 516,024 shares of our common stock. Each shareholder of Acacia received 0.68 euros in cash and 0.0049 shares of our common stock. Acacia is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery and other invasive procedures. The transaction was entered to expand our current portfolio of FDA approved hospital products with the addition of Barhemsys and Byfavo. We evaluated the Business Acquisition under ASC 805, Business Combinations and ASU 2017-01, Business Combinations: Clarifying the Definition of a Business. We concluded that substantially all of the fair value of the gross assets acquired is not concentrated in a single identifiable asset or a group of similar identifiable assets. The transaction does not pass the screen test and thus management performed an assessment to determine if the acquired entities met the definition of a business. For the assessment, management considered whether it has acquired (i) inputs, (ii) processes, and (iii) outputs. Under ASC 805, to be considered a business, a set of activities and assets is required to have only the first two of the three elements, which together are or will be used in the future to create outputs. Management determined that the acquired entities met the definition of a business since we acquired inputs, processes capable of producing outputs and outputs. Therefore, the acquisition has been accounted for under the acquisition method of accounting. Under the acquisition method, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on the fair values as of the date of the acquisition. During the three months ended September 30, 2022, we recorded certain measurement period adjustments that totaled $1.3 million. The impact of these measurement period adjustments were recorded as a reduction to goodwill, reducing the initial goodwill balance of $3.3 million recorded in the three months ended June 30, 2022. The amount recognized will be finalized as the information necessary to complete the analysis is obtained but no later than one year after the acquisition date. The fair value of the consideration totaled $100.4 million, summariz ed as follows (in thousands): Fair Value of Consideration Cash consideration $ 76,708 Fair value of Eagle common stock issued 23,645 $ 100,353 We recorded the assets acquired and liabilities assumed as of the date of the acquisition based on the information available as of that date. As we finalize the fair values of the assets acquired and liabilities assumed, purchase price adjustments may be recorded during the measurement period and such adjustments could be material. We will reflect measurement period adjustments, if any, in the period in which the adjustments are recognized. The following table presents the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands): Preliminary Purchase Price Allocation as of acquisition date Measurement Period Adjustments Preliminary Purchase Price Allocation as of September 30, 2022 Cash $ 2,556 $ — $ 2,556 Net working capital, excluding cash (2,158) — (2,158) Inventory 26,942 — 26,942 Intangible assets 104,000 — 104,000 Debt (28,503) — (28,503) Deferred tax liability, net (4,536) — (4,536) Fair value of net assets acquired 98,301 — 98,301 Goodwill 3,315 (1,263) 2,052 $ 101,616 $ (1,263) $ 100,353 The fair value of acquired intangible assets was based on the present value of expected future after tax cash flows attributable to the commercialization of Barhemsys and Byfavo, using the net present value approach. The inventory acquired was valued at expected profit margins for the acquired products. The fair value of working capital acquired approximates its book value. The fair value of debt acquired was based on the present value of future cash outflows using the net present value approach and applying an interest rate that is considered to be a market participant equivalent rate. We incurred approximately $1.1 million and $12.4 million in acquisition-related expenses, which were included in selling, general and administrative expenses in the condensed consolidated statements of operations for the three and nine months ended September 30, 2022. These expenses primarily consist of legal fees and success fees paid to third party advisors. The results of Acacia operations have been included in our condensed consolidated statements of operations beginning on the acquisition date. The acquired business contributed revenues of $0.9 million and net loss of $15.5 million to us for the period from June 9, 2022 to September 30, 2022. The goodwill recorded related to the acquisition is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of acquisition. The goodwill recorded is not deductible for tax purposes. Pro Forma Financial Information: The following table provides unaudited pro forma financial information for the three-month and nine-month periods ended September 30, 2022 and 2021 as if the acquisition of Acacia had occurred as of January 1, 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Total revenue $ 65,901 $ 48,400 $ 257,093 $ 90,090 Net (loss) income $ (7,131) $ (14,905) $ 10,752 $ (41,471) These amounts have been calculated after applying our accounting policies. The pro forma results above include the impact of the following adjustments, as necessary: additional amortization expense relating to assets acquired; interest and other financing costs relating to the acquisition transaction; and the elimination of one-time or nonrecurring items. The one-time or nonrecurring items eliminated were primarily comprised of inventory fair value step-up adjustments; transaction costs, as well as certain Acacia-related share based payment charges and employee compensation expenses. The pro forma results do not include any anticipated cost savings or other effects of the planned integration of Acacia. Accordingly, the pro forma results above are not necessarily indicative of the results that would have been if the acquisition had occurred on the dates indicated, nor are the pro forma results indicative of results which may occur in the future. |
Investment in Enalare Therapeut
Investment in Enalare Therapeutics Inc. | 9 Months Ended |
Sep. 30, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Investment in Enalare Therapeutics Inc. | Investment in Enalare Therapeutics Inc. On August 8, 2022, we and Enalare Therapeutics Inc. (“Enalare”) entered into a Securities Purchase Agreement, pursuant to the terms of the Shares Purchase Agreement ("SPA"), we are obligated to further invest in Enalare, an additional $12.5 million no later than February 2023 and may invest an additional $30 million, subject to the completion of certain development milestones. Concurrently with the execution of the SPA, we also entered into a Security Purchase Option Agreement ("SPOA"), pursuant to which we were granted an option to acquire all of the remaining outstanding shares of Enalare other than those that we already own, subject to the terms and conditions of the agreement. The term of the Purchase Option (the "Option Period") commenced on August 8, 2022 and will end upon the earlier of (x) 90 days following the FDA communication of proceed to clinical for a Phase 3 clinical study for a Product Candidate or (y) June 30, 2027. Enalare shall not initiate Phase 3 pivotal studies prior to the end of the Option Period and we shall have reasonable access to all relevant data and documents following the Phase 3 Milestone (as defined in the Option Agreement). Upon entering the Purchase Agreement, we recorded an equity investment in the amount of $8.4 million, an asset related to the acquisition right in the amount of $8.1 million and a forward liability of $4.1 million related to the contractual obligation to invest another $12.5 million within six months from August 2022 in accordance with ASC 321 Investments – Equity Securities . We used a probability factor to value the asset related to the acquired acquisition rights based on management's best estimate, including the probability of completion of certain development milestones. The equity stake was accounted for as an non-RDFV investment. The equity investment, acquisition right, and forward liability was reported at fair value as of September 30, 2022. Summarized financial information of our investment and equity ownership in Enalare for the three months ending September 30, 2022 is presented below: Beginning balance as of June 30, 2022 Additions during period Adjustments Ending balance as of September 30, 2022 Non-RDFV Investment $ — $ 8,438 $ — $ 8,438 Acquisition Rights (Other assets) — $ 8,125 — $ 8,125 Forward Liability (Accrued expenses and other liabilities) — $ (4,063) — $ (4,063) Total, net $ — $ 12,500 $ — $ 12,500 |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event On November 1, 2022, we entered into the Third Amended and Restated Credit Agreement (“Third Amended Credit Agreement”), with JPMorgan Chase Bank, N.A., as administrative (the “Administrative Agent”) and the lenders party thereto, which replaced the Prior Credit Agreement, dated as of November 8, 2019. The terms and amounts borrowed under the Third Amended Credit Agreement includes a drawn term loan of $50 million and a $100 million revolving credit facility of which $15 million was drawn on November 1, 2022. On the effective date for the Third Amended Credit Agreement, we borrowed $15 million under the revolving credit facility and $50 million under the term loan facility. Approximately $35.4 million of the proceeds of the credit facility were used to refinance all amounts outstanding under the Prior Credit Agreement, to repay certain indebtedness of Acacia, and for other corporate purposes. The new maturity date of the schedule of principal payments for each of the revolving credit facility and the term loan facility is October 31, 2025, unless required to mature earlier or extended pursuant to the terms of the Third Amended Credit Agreement. Loans under the Third Amended Credit Agreement bear interest, at our option, at a rate equal to either (a) the SOFR rate, plus a credit adjustment spread, plus an applicable margin ranging from 2.50% to 3.25% per annum, based upon the total net leverage ratio (as defined in the Third Amended Credit Agreement), or (b) the prime lending rate, plus an applicable margin ranging from 1.50% to 2.25% per annum, based upon the total net leverage ratio. We are required to pay a commitment fee on the unused portion of the new revolving credit facility in the Third Amended Credit Agreement at a rate ranging from 0.35% to 0.45% per annum based upon the total net leverage ratio. The term loan facility payments will be made in quarterly installments in an amount equal to $1.25 million per fiscal quarter for each fiscal quarter ended after the closing date for the Third Amended Credit Agreement through the fiscal quarter ended September 30, 2023, and in an amount equal to $2.5 million per fiscal quarter for each fiscal quarter thereafter. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Business Combinations and Asset Acquisitions | Business combinations and asset acquisitions - The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs, process, and output, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”) Accounting Standards Update ("ASU") 2017-01, “Business Combinations”, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including any contingent assets and liabilities, and any non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with Accounting Standards Codification (“ASC”) 805 - Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, would be recognized as a gain or loss and recorded condensed consolidated statement of operations. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50 Business Combinations – Related Issues, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s financial statements. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. |
Use of Estimates | Use of Estimates These condensed consolidated financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements including disclosure of gross to net estimates as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. Our critical accounting policies are those that are both most important to our financial condition and results of operations and also 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 uncertai n. We anticipate that the COVID-19 pandemic will continue to disrupt our supply chain and marketing and sales efforts for certain of our products, although it is not currently expected that any disruption would be significant. As of the date of issuance of these condensed consolidated financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the condensed consolidated financial statements, actual results may materially vary from these estimates, and any such differences may be material to our condensed consolidated financial statements. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. We, at times, maintain balances with financial institutions in excess of the Federal Deposit Insurance Corporation (“FDIC”) limit. |
Fair Value Measurements | Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of interest-bearing cash, cash equivalents, accounts receivable and accounts payable approximate fair value due to their life being short term in nature, and are classified as Level 1 for all periods presented. We recognize transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three and nine months ended September 30, 2022. Our investment in Enalare Therapeutics Inc., related acquisition right and forward liability were classified as Level 3. We analyzed and accessed the contractual obligation to invest another $12.5 million within six months from August 2022, along with the purchase option included within the Securities Purchase Agreement (“SPA”). We used a probability factor to value the asset related to the acquired acquisition rights based on management's best estimate, including the probability of completion of certain development milestones. The equity stake was accounted for as non-readily determinable fair value (“RDFV”) investment. The equity investment and acquisition right was reported at fair value as of September 30, 2022. Refer to Note 15, Investment in Enalare Therapeutics Inc. for further information. Our investment in restricted shares of common stock of Syros Pharmaceuticals, Inc. ("Syros"), following the merger of Tyme Technologies, Inc. (“Tyme”) and Syros on September 16, 2022, are classified as Level 1. Refer to Note 12, License and Collaboration Agreements for further details. As of December 31, 2021, our investment in the convertible promissory note and the embedded derivative were classified as Level 3. We analyzed and accessed the embedded derivative feature contained in the convertible promissory note agreement. We used a probability factor to value the embedded derivative asset based on management's best estimate, including the principal and estimated accrued interest among other contractual terms. The convertible promissory note was accounted for as available for sale. The convertible promissory note was reported at fair value with unrealized gains and losses included in Accumulated other comprehensive income (loss). Refer to Note 13, Convertible Promissory Note for further details. In the first quarter of 2022, we entered into a forward contract to purchase euros at a forward rate. The contract settled in the second quarter of 2022 and was used to economically hedge the cost of the acquisition of Acacia. In second quarter of 2022, we entered into an additional forward contract to purchase euros at a forward rate. The contract was net settled in the third quarter of 2022 and was used to economically hedge the euro-dominated debt of Acacia that we assumed in connection with our acquisition all of the outstanding share capital of Acacia in June 2022. For the three and nine months ended September 30, 2022, the fair value adjustment on the forward contract was a loss of $0.7 million and a loss of $6.3 million, respectively, and the adjustments were recorded in Other (expense) income on our condensed consolidated statement of operations. The fair value of the previously existing legacy term loan is classified as Level 2 for the periods presented and approximates its book value due to the variable interest rate. The fair value of the euro-denominated loan that we assumed as part of our acquisition of Acacia is classified as Level 2 and was recorded on the balance sheet at fair value upon acquisition. |
Intangible Assets | Intangible Assets We review the recoverability of our finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, we measure the amount of the impairment by comparing to the carrying value of the assets to the fair value of the assets. We determined that no indicators of impairment of finite-lived intangible assets or long-lived assets existed as of September 30, 2022. |
Goodwill | GoodwillGoodwill represents the excess of purchase price over the fair value of net assets acquired in the Eagle Biologics and Acacia acquisitions. Goodwill is not amortized, but is evaluated for impairment on an annual basis, in the fourth quarter, or more frequently if events or changes in circumstances indicate that the reporting unit’s goodwill is less than its carrying amount. |
Concentration of Major Customers and Vendors | Concentration of Major Customers and Vendors The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's 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. The Company does not currently have a material allowance for collectible trade receivables. Further, 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 on our balance sheet, results of operations and cash flows. |
Inventories | Inventories Inventories are recorded at the lower of cost and net realizable value, with cost determined on a first-in first-out basis. We periodically review the composition of inventory in order to identify obsolete, slow-moving or otherwise non-saleable items. If these items are observed and there are no alternate uses for the inventory, we will record a write-down to lower of cost and net realizable value in the period that the decline in value is first recognized. |
Research and Development Expense | Research and Development Expense Costs for research and development are charged to expense as incurred and include; employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities, costs associated with regulatory operations; and depreciation expense for assets used in research and development activities. Costs for certain development activities, such as in licensing intellectual property related to new projects, clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the condensed consolidated financial statements as prepaid expenses or accrued expenses as deemed appropriate. Recoveries of previously recognized research and development expenses from third parties are recorded as a reduction to research and development expense in the period it becomes realizable. |
Advertising and Marketing | Advertising and MarketingAdvertising and marketing costs are expensed as incurred. |
Income Taxes | Income Taxes We account for income taxes using the liability method in accordance with ASC 740 - Income Taxes (“ASC 740”). Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income (loss) in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. ASC 740 also prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that a company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. |
Revenue Recognition | Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606 - Revenue from Contracts with Customers ("ASC 606"), 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 purchases of product launch quantities. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price generally utilizing the expected value method to which the Company expects to be entitled. As such, revenue on sales to end users for vasopressin, Pemfexy, Belrapzo, Ryanodex, Barhemsys, and Byfavo are recorded net of chargebacks, rebates, returns, prompt pay discounts, wholesaler fees and other deductions. Our products are contracted with a limited number of oncology distributors and hospital buying groups with narrow differences in ultimate realized contract prices used to estimate our allowance for chargebacks and rebate reserves. The Company has a product returns policy on some of its products that allows the customer to return pharmaceutical products within a specified period of time both prior to and subsequent to the product’s expiration date. The Company's estimate of the provision for returns is analyzed quarterly and is based upon many factors, including historical experience of actual returns and analysis of the level of inventory in the distribution channel, if any. The Company has terms on sales of Ryanodex by which the Company does not accept returns. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration are made generally using the expected value method and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. The Company believes that the estimates it has established are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. Components of Gross-to-Net (GTN) Estimates Chargebacks : Chargebacks are discounts that occur when certain contracted customers, including group purchasing organizations (“GPOs”), public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase from the Company's distributors. The Company's distributors purchase product from us at invoice price, then resell the product to certain contracted customers on the basis of prices negotiated between us and the providers. The difference between the distributors’ purchase price and the typically lower certain contracted customers’ purchase price is refunded to the distributors through a chargeback credit. We record estimates for these chargebacks at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances. The provision for chargebacks is the most significant provision in the context of the Company’s gross-to-net adjustments in the determination of net revenue. Chargebacks are estimated based on payer mix and contracted price, adjusted for current period assumptions. Commercial and Medicaid Rebates : The Company contracts with government agencies or collectively, third-party payors, so that vasopressin, Pemfexy, Belrapzo, Ryanodex, Barhemsys, and Byfavo will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payer mix, and (iv) information obtained from the Company’s distributors. The information that the Company also considers when establishing its rebate reserves are purchases by customers, projected annual sales for customers, actual rebates payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its largest distributors for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels. Product Returns : The Company's provision for product returns based on the factors noted above generally encompass a time range from 12 to 48 months after revenue is recognized. The Company’s distributors have the right to return unopened unprescribed vasopressin, Pemfexy, Belrapzo, Barhemsys, and Byfavo during certain time periods around the period beginning prior to the labeled expiration date and ending after the labeled expiration date. The Company estimates future product returns on sales of vasopressin, Pemfexy, Belrapzo, Barhemsys, and Byfavo based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iii) historical industry information regarding return rates for similar pharmaceutical products, (iv) the estimated remaining shelf life of vasopressin, Pemfexy, Belrapzo, Barhemsys, and Byfavo previously shipped and currently being shipped to distributors and (v) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. Wholesaler fees and other incentives : The Company generally provides invoice discounts on vasopressin, Pemfexy, Belrapzo, Ryanodex, Barhemsys, and Byfavo sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors generally include a 2% discount for prompt payment which is generally defined in invoice terms as a range from 15 to 45 days, while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. In certain cases, the Company may record the fees as accrued expenses if the Company expects that the fees will be paid rather than deducted by the distributor. Royalty Revenue — The Company recognizes revenue from license arrangements with its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 25 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. Our receivables from royalty revenue are due 45-days from the end of the quarter. License and other revenue — The Company analyzes each element of its licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, the Company determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of these future events, the Company will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. |
Stock-Based Compensation | Stock-Based Compensation The Company utilizes stock-based compensation in the form of stock options, restricted stock units ("RSUs") and performance-based stock units ("PSUs"), each of which may be granted separately or in tandem with other awards. Compensation expense is recognized in the Consolidated Statements of operations based on the estimated fair value of the awards at grant date ratably over the requisite service period, which generally equals the vesting period of the award. The grant-date fair value of stock awards is based upon the underlying price of the stock on the date of grant. The grant-date fair value of stock option awards must be determined using an option pricing model. The Company uses the Black-Scholes option pricing formula for determining the grant-date fair value of such awards. Option pricing models require the use of estimates and assumptions as to (a) the expected term of the option, (b) the expected volatility of the price of the underlying stock and (c) the risk-free interest rate for the expected term of the option. The Company may also grant performance-based stock awards to employees from time-to-time in form of market condition or performance condition. The grant-date fair value of awards that vest based on achievement of certain market condition are determined using a Monte Carlo simulation technique. The grant-date fair value of awards that vest based on achievement of certain performance condition are determined using the accelerated attribution method once it is probable that the performance condition will be achieved. |
Earnings Per Share | Earnings Per 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 options. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share, as calculated under the treasury method. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In March 2020, the FASB issued Update 2020-04 Reference Rate Reform (Topic 848), Facilitation of the Effects of Reference Rate Reform on Financial Reporting to provide temporary optional guidance to ease the potential burden in accounting for reference rate reform. The amendments in Update 2020-04 are elective and apply to all entities that have contracts, hedging relationships, and other transactions that reference LIBOR, formerly known as the London Interbank Offered Rate, or another reference rate expected to be discontinued due to reference rate reform. The new guidance provides optional expedients, including; (1) Simplify accounting analyses under current GAAP for contract modifications, such as modifications of contracts within the scope of Topic 470, Debt, that will be accounted for by prospectively adjusting the effective interest rate, as if any modification was not substantial. That is, the original contract and the new contract shall be accounted for as if they were not substantially different from one another; (2) Simplify the assessment of hedge effectiveness and allow hedging relationships affected by reference rate reform to continue; (3) Allow a one-time election to sell or transfer debt securities classified as held to maturity before January 1, 2020 that reference a rate affected by reference rate reform. The amendments are effective for all entities from the beginning of an interim period that includes the issuance date of the ASU. An entity may elect to apply the amendments prospectively through December 31, 2022. The adoption of ASU 2020-4 is not expected to have a material impact on our financial position or results of operations. In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers , which requires an acquirer to recognize and measure contract assets and liabilities acquired in a business combination in accordance with Revenue from Contracts with Customers (Topic 606) rather than adjust them to fair value at the acquisition date. This accounting standard update will be effective for public business entities in fiscal years beginning after December 15, 2022, including interim periods within those fiscal years; therefore for us beginning in the first quarter of 2023. We are currently evaluating the impact of this accounting standard, but do not expect it to have a material impact on our condensed consolidated financial statements. In March 2022, the FASB issued ASU 2022-01, Derivatives and Hedging (Topic 801): Fair Value Hedging – Portfolio Layer Method , which expands the current single-layer hedging model to allow multiple-layer hedges of a single closed portfolio of prepayable financial assets or one or more beneficial interests secured by a portfolio of prepayable financial instruments under the method. This accounting standards update will be effective for public business entities in fiscal years beginning after December 15, 2022, including interim periods within those fiscal years; therefore for us beginning in the first quarter of 2023. We are currently evaluating the impact of this accounting standard, but do not expect it to have a material impact on our condensed consolidated financial statements. There are other new accounting pronouncements issued by the FASB that we have adopted or will adopt, as applicable. We do not believe any of these accounting pronouncements have had, or will have, a material impact on our condensed consolidated financial statements or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of financial assets and liabilities measured and recognized at fair value | Financial assets and liabilities measured and recognized at fair value are as follows: September 30, 2022 Total Level 1 Level 2 Level 3 Assets: Investment in Syros Pharmaceuticals, Inc. ("Syros") $ 2,882 $ 2,882 $ — $ — Investment in Enalare Therapeutics, Inc. 8,438 — — 8,438 Acquisition rights of Enalare Therapeutics, Inc. 8,125 — — 8,125 Liability: Forward Liability 4,063 — — 4,063 December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 57,357 $ 57,357 $ — $ — Convertible promissory note 4,021 — — 4,021 Embedded derivative asset in convertible promissory note 962 — — 962 Investment in Tyme 6,030 6,030 — — |
Schedule of revenues and accounts receivables by major customers | The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Total revenues Teva - See Revenue Recognition 39 % 69 % 32 % 66 % Customer A 8 % 1 % 16 % 6 % Customer B 15 % 9 % 13 % 8 % Customer C 14 % 3 % 13 % 4 % Customer D 10 % 11 % 9 % 10 % Other 14 % 7 % 17 % 6 % 100 % 100 % 100 % 100 % September 30, December 31, 2022 2021 Accounts receivable Teva - See Revenue Recognition 27 % 63 % Customer A 24 % 13 % Customer B 16 % 13 % Customer C 7 % 2 % Customer D 6 % 2 % Other 20 % 7 % 100 % 100 % |
Schedule of dilutive and anti-dilutive common shares equivalents outstanding | The anti-dilutive common share equivalents outstanding for the three and nine months ended September 30, 2022 and 2021 were as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options 2,627,704 2,446,657 2,546,760 2,777,995 Restricted stock units 241,789 — 238,039 123,600 Total 2,869,493 2,446,657 2,784,799 2,901,595 |
Computation for basic and diluted net (loss) earnings per share | The following table sets forth the computation for basic and diluted net (loss) earnings per share for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Numerator Net (loss) income $ (7,131) $ (5,622) $ 27,477 $ (2,431) Denominator Basic weighted average common shares outstanding 13,166,931 13,077,298 12,906,235 13,103,203 Dilutive effect of stock awards — — 145,076 — Diluted weighted average common shares outstanding 13,166,931 13,077,298 13,051,311 13,103,203 Basic net (loss) earnings per share Basic net (loss) earnings per share $ (0.54) $ (0.43) $ 2.13 $ (0.19) Diluted net (loss) earnings per share Diluted net (loss) earnings per share $ (0.54) $ (0.43) $ 2.11 $ (0.19) |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment, net | Property and equipment consisted of the following: September 30, 2022 December 31, 2021 Estimated Useful Life (years) Furniture and fixtures $ 1,525 $ 1,525 7 Office equipment 1,077 1,077 3 Equipment 4,003 3,834 7 Leasehold improvements 1,155 1,155 2 7,760 7,591 Less accumulated depreciation (6,463) (5,955) Property and equipment, net $ 1,297 $ 1,636 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of the following: September 30, December 31, 2022 2021 Raw materials (1) $ 9,704 $ 7,317 Work in process (2) 21,246 9,666 Finished products (3) 32,905 4,925 Total inventories $ 63,855 $ 21,908 (1) $1.7 million of Raw materials represents inventory acquired with Acacia as detailed in Note 14. (2) $2.9 million of Work in process represents inventory acquired with Acacia as detailed in Note 14. (3) $21.8 million of Finished products represents inventory acquired with Acacia as detailed in Note 14. |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of prepaid and other current assets | Prepaid expenses and other current assets consist of the following: September 30, December 31, 2022 2021 Prepaid income taxes $ 566 $ 1,173 Prepaid FDA user fee and advances to clinical research organization — 1,108 Prepaid insurance 537 196 Advances to commercial manufacturers 3,164 2,354 Prepaid R&D 1,445 — Convertible promissory note, net — 5,312 Other receivable related to cost sharing arrangement with commercial partner 998 347 All other 2,165 1,400 Total prepaid expenses and other current assets $ 8,875 $ 11,890 |
Schedule of accrued expenses | Accrued expenses consist of the following: September 30, December 31, 2022 2021 Accrued product sales reserves $ 21,662 $ 4,390 Income taxes payable 5,750 — Royalties payable to commercial partners 9,724 5,085 Accrued salary and other compensation 3,702 8,466 Accrued professional fees 7,622 2,013 Accrued research & development 4,233 4,100 Current portion of lease liability 1,508 1,309 Inventory received but not invoiced 14,431 6,177 Forward liability 4,063 — Accrued other 957 798 Total accrued expenses $ 73,652 $ 32,338 |
Lease related disclosures | The table below summarizes our total lease costs included in the condensed consolidated financial statements, as well as other required quantitative disclosures (in thousands): September 30, 2022 December 31, 2021 Operating lease cost $ 1,173 $ 1,407 Total lease cost $ 1,173 $ 1,407 Other information: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 1,173 $ 1,407 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 270 Weighted-average remaining lease term - operating leases 2.3 years 3.1 years Weighted-average discount rate - operating leases 6.0 % 6.0 % |
Future minimum lease payments | Balance Sheet Classification as of September 30, 2022: Current lease liabilities (included with Accrued expenses and other liabilities) $ 1,508 Long-term lease liabilities (included with Other long-term liabilities) 1,874 Total lease liabilities $ 3,382 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible asset | The gross carrying amounts and net book value of our intangible assets are as follows: September 30, 2022 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Barhemsys intangible (1) 9 $ 68,000 $ (2,425) $ 65,575 Byfavo intangible (1) 9 36,000 (1,193) 34,807 Ryanodex intangible (2) 9 15,000 (6,821) 8,179 Vasopressin milestone (3) 1 750 (526) 224 Total $ 119,750 $ (10,965) $ 108,785 December 31, 2021 Useful Life (In Years) Gross Carrying Amount Accumulated Amortization Net Book Value Ryanodex intangible (2) 9 $ 15,000 $ (5,079) $ 9,921 Developed technology 5 8,100 (8,100) — Vasopressin milestone (3) 1 750 — 750 Total $ 23,850 $ (13,179) $ 10,671 (1) Represents intangible assets acquired in the Acacia acquisition as detailed in Note 14. (2) Represents a one-time payment made to reduce the royalties payable to a third party on Ryanodex net sales. |
Schedule of future amortization expense of finite-lived intangible assets | Based on definite-lived intangible assets recorded as of September 30, 2022, and assuming that the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses are estimated as follows: Estimated Amortization Expense Year Ending December 31, 2022 (remainder) 3,690 2023 14,405 2024 14,127 2025 13,886 2026 11,584 Thereafter 51,093 Total estimated amortization expense $ 108,785 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of stock options, RSU and PSU activity | A summary of stock option, RSU and PSU activity under the 2014 Plan during the nine months ended September 30, 2022 and 2021 is presented below: Stock Options RSUs PSUs Outstanding as of December 31, 2020 3,331,890 328,396 97,750 Granted 109,000 106,600 159,000 Stock options exercised/RSUs vested/PSUs vested (100,477) (94,273) — Forfeited or expired (308,815) (46,941) (97,750) Outstanding as of September 30, 2021 3,031,598 293,782 159,000 Outstanding as of December 31, 2021 2,814,878 263,306 137,300 Granted 123,700 148,000 228,200 Stock options exercised/RSUs vested/PSUs vested (91,255) (101,898) — Forfeited or expired (73,983) (36,616) (46,400) Outstanding as of September 30, 2022 2,773,340 272,792 319,100 |
Fair value of stock options | The fair value of stock options granted to employees, directors, and consultants were estimated using the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Risk-free interest rate 2.83% - 3.66% 0.82% - 0.93% 1.47% - 3.66% 0.51% - 1.12% Volatility 46.69% 54.92% 46.83% 56.07% Expected term (in years) 6.08 years 6.08 years 5.76 years 5.68 years Expected dividend yield 0.0% 0.0% 0.0% 0.0% |
Share-based payment arrangement, cost by plan | We recognized stock-based compensation in our condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options $ 1,597 $ 2,515 $ 5,131 $ 8,393 RSUs 989 1,046 3,913 4,051 PSUs 951 523 3,288 2,429 Stock-based compensation expense $ 3,537 $ 4,084 $ 12,332 $ 14,873 Selling, general and administrative $ 2,937 $ 3,443 $ 10,488 $ 12,696 Research and development 600 641 1,844 2,177 Stock-based compensation expense $ 3,537 $ 4,084 $ 12,332 $ 14,873 |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of operating lease obligations and purchase obligations | Our future material contractual obligations as of September 30, 2022, included the following: Obligations Total 2022 2023 2024 2025 Beyond Operating leases (1) $ 3,621 $ 414 $ 1,672 $ 1,122 $ 413 $ — Credit facility and Term Loans (2) 59,324 35,000 4,257 12,162 7,905 — Investment in Enalare (4) 12,500 — 12,500 — — — Purchase obligations (3) 99,403 99,403 — — — — Total obligations $ 174,848 $ 134,817 $ 18,429 $ 13,284 $ 8,318 $ — (1) We lease our corporate office location. The term of our existing lease expires on June 30, 2025. We also lease our lab space under a lease agreement through April 2024, office space located in Indianapolis, Indiana through November 2023, and an office space in Palm Beach Gardens, Florida, through October 31, 2024. Rental expense for the operating leases was $0.4 million and $0.3 million, for the three months ended September 30, 2022 and 2021, respectively. Rental expense for the operating leases was $1.2 million and $1.0 million for the nine months ended September 30, 2022 and 2021.The remaining future lease payments under the operating leases are $3.6 million as of September 30, 2022. (2) Refer to Note 9, “Debt” for further information regarding our Credit Agreement and Term Loans. (3) As of September 30, 2022, we had purchase obligations in the amount of $99.4 million which represents the contractual commitments under contract manufacturing and supply agreements with suppliers. The obligations under the supply agreements are primarily for finished product, inventory, and research and development. (4) We invested $12.5 million in Enalare at the time of entering the agreement in August 2022, and we are contractually obligated to invest another $12.5 million six months after August 2022. Refer to Note 15 for further details. |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of debt maturities | Debt Maturities As of September 30, 2022 2022 (remainder) $ 35,000 2023 4,257 2024 12,162 2025 7,905 Total $ 59,324 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Income tax (provision) benefit $ (3,468) $ 7,038 $ (20,652) $ 3,341 Effective tax rate (95) % 56 % 43 % 58 % |
Convertible Promissory Note (Ta
Convertible Promissory Note (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Debt Securities, Available-for-sale | The following table summarizes the activity during the three months ended September 30, 2022; June 30, 2022 Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative September 30, 2022 Fair value of the note $ 5,510 $ (5,510) $ — $ — $ — $ — $ — Discount on the note (36) 36 — — — — — Estimated Credit Loss (820) — — 820 — — — Convertible Promissory Note, net $ 4,654 $ (5,474) $ — $ 820 $ — $ — $ — Embedded Derivative $ 1,026 $ — $ — $ — $ — $ (1,026) $ — Interest Receivable $ 530 $ — $ — $ (530) $ — $ — $ — Total in Other Current Assets $ 6,210 $ (5,474) $ — $ 290 $ — $ (1,026) $ — The following table summarizes the amounts recorded and activity during the nine months ended September 30, 2022; December 31, 2021 Fair Value Adjustments to the note Accretion of Discount Estimated Credit Loss Interest Income Fair Value Adjustment to Embedded Derivative September 30, 2022 Fair value of the note $ 4,906 $ (4,906) $ — $ — $ — $ — $ — Discount on the note (127) — 127 — — — — Estimated Credit Loss (758) — — 758 — — — Convertible Promissory Note, net $ 4,021 $ (4,906) $ 127 $ 758 $ — $ — $ — Embedded Derivative $ 962 $ — $ — $ — $ — $ (962) $ — Interest Receivable $ 329 $ — $ — $ (329) $ — $ — $ — Total in Other Current Assets $ 5,312 $ (4,906) $ 127 $ 429 $ — $ (962) $ — |
Business Acquisition (Tables)
Business Acquisition (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Schedule of Business Acquisitions, by Acquisition | The fair value of the consideration totaled $100.4 million, summariz ed as follows (in thousands): Fair Value of Consideration Cash consideration $ 76,708 Fair value of Eagle common stock issued 23,645 $ 100,353 |
Schedule of Recognized Identified Assets Acquired and Liabilities Assumed | The following table presents the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands): Preliminary Purchase Price Allocation as of acquisition date Measurement Period Adjustments Preliminary Purchase Price Allocation as of September 30, 2022 Cash $ 2,556 $ — $ 2,556 Net working capital, excluding cash (2,158) — (2,158) Inventory 26,942 — 26,942 Intangible assets 104,000 — 104,000 Debt (28,503) — (28,503) Deferred tax liability, net (4,536) — (4,536) Fair value of net assets acquired 98,301 — 98,301 Goodwill 3,315 (1,263) 2,052 $ 101,616 $ (1,263) $ 100,353 |
Business Acquisition, Pro Forma Information | The following table provides unaudited pro forma financial information for the three-month and nine-month periods ended September 30, 2022 and 2021 as if the acquisition of Acacia had occurred as of January 1, 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Total revenue $ 65,901 $ 48,400 $ 257,093 $ 90,090 Net (loss) income $ (7,131) $ (14,905) $ 10,752 $ (41,471) |
Investment in Enalare Therape_2
Investment in Enalare Therapeutics Inc. (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Schedule of equity method investments | Summarized financial information of our investment and equity ownership in Enalare for the three months ending September 30, 2022 is presented below: Beginning balance as of June 30, 2022 Additions during period Adjustments Ending balance as of September 30, 2022 Non-RDFV Investment $ — $ 8,438 $ — $ 8,438 Acquisition Rights (Other assets) — $ 8,125 — $ 8,125 Forward Liability (Accrued expenses and other liabilities) — $ (4,063) — $ (4,063) Total, net $ — $ 12,500 $ — $ 12,500 |
Basis of Presentation and Oth_2
Basis of Presentation and Other Company Information (Details) | 9 Months Ended |
Sep. 30, 2022 product | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of products commercially launched | 6 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Financial Assets and Liabilities Measured and Recognized at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Assets: | |||
Investments | $ 6,030 | ||
Acquisition rights of Enalare Therapeutics, Inc. | $ 8,125 | ||
Money market funds | 57,357 | ||
Convertible promissory note | 4,021 | ||
Embedded derivative asset in convertible promissory note | 962 | ||
Liability: | |||
Forward Liability | 4,063 | ||
Investment in Syros Pharmaceuticals, Inc. ("Syros") | |||
Assets: | |||
Investments | 2,882 | ||
Investment in Enalare Therapeutics, Inc. | |||
Assets: | |||
Investments | 8,438 | $ 0 | |
Acquisition rights of Enalare Therapeutics, Inc. | 8,125 | 0 | |
Liability: | |||
Forward Liability | 4,063 | $ 0 | |
Level 1 | |||
Assets: | |||
Investments | 6,030 | ||
Acquisition rights of Enalare Therapeutics, Inc. | 0 | ||
Money market funds | 57,357 | ||
Convertible promissory note | 0 | ||
Embedded derivative asset in convertible promissory note | 0 | ||
Liability: | |||
Forward Liability | 0 | ||
Level 1 | Investment in Syros Pharmaceuticals, Inc. ("Syros") | |||
Assets: | |||
Investments | 2,882 | ||
Level 1 | Investment in Enalare Therapeutics, Inc. | |||
Assets: | |||
Investments | 0 | ||
Level 2 | |||
Assets: | |||
Investments | 0 | ||
Acquisition rights of Enalare Therapeutics, Inc. | 0 | ||
Money market funds | 0 | ||
Convertible promissory note | 0 | ||
Embedded derivative asset in convertible promissory note | 0 | ||
Liability: | |||
Forward Liability | 0 | ||
Level 2 | Investment in Syros Pharmaceuticals, Inc. ("Syros") | |||
Assets: | |||
Investments | 0 | ||
Level 2 | Investment in Enalare Therapeutics, Inc. | |||
Assets: | |||
Investments | 0 | ||
Level 3 | |||
Assets: | |||
Investments | 0 | ||
Acquisition rights of Enalare Therapeutics, Inc. | 8,125 | ||
Money market funds | 0 | ||
Convertible promissory note | 4,021 | ||
Embedded derivative asset in convertible promissory note | $ 962 | ||
Liability: | |||
Forward Liability | 4,063 | ||
Level 3 | Investment in Syros Pharmaceuticals, Inc. ("Syros") | |||
Assets: | |||
Investments | 0 | ||
Level 3 | Investment in Enalare Therapeutics, Inc. | |||
Assets: | |||
Investments | $ 8,438 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Investment in contractual obligation within another six months | $ 12,500,000 | $ 12,500,000 | ||
Goodwill impairment loss | 0 | $ 0 | 0 | $ 0 |
Advertising and marketing costs | $ 1,700,000 | $ 500,000 | $ 5,100,000 | $ 1,300,000 |
Wholesaler discount (as a percent) | 2% | 2% | ||
Minimum | ||||
Disaggregation of Revenue [Line Items] | ||||
Wholesaler discount, prompt payment term (in days) | 15 days | |||
Maximum | ||||
Disaggregation of Revenue [Line Items] | ||||
Wholesaler discount, prompt payment term (in days) | 45 days | |||
Product sales, net | Minimum | ||||
Disaggregation of Revenue [Line Items] | ||||
Payment terms for receivables (in days) | 30 days | |||
Term for sales returns (in months) | 12 months | |||
Product sales, net | Maximum | ||||
Disaggregation of Revenue [Line Items] | ||||
Payment terms for receivables (in days) | 75 days | |||
Term for sales returns (in months) | 48 months | |||
Royalty revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Payment terms for receivables (in days) | 45 days | |||
Reporting term from end of each quarter for commercial partners (in days) | 25 days | |||
Q2 2022 Foreign Exchange Forward | Other Nonoperating Income (Expense) | Not Designated as Hedging Instrument | ||||
Disaggregation of Revenue [Line Items] | ||||
Fair value adjustment on forward contract loss | $ 700,000 | $ 6,300,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Revenue and Accounts Receivable By Major Customer (Details) - Customer Concentration Risk | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Total revenues | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 100% | 100% | 100% | 100% | |
Total revenues | Teva | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 39% | 69% | 32% | 66% | |
Total revenues | Customer A | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 8% | 1% | 16% | 6% | |
Total revenues | Customer B | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 15% | 9% | 13% | 8% | |
Total revenues | Customer C | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 14% | 3% | 13% | 4% | |
Total revenues | Customer D | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 10% | 11% | 9% | 10% | |
Total revenues | Other | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 14% | 7% | 17% | 6% | |
Accounts receivable | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 100% | 100% | |||
Accounts receivable | Teva | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 27% | 63% | |||
Accounts receivable | Customer A | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 24% | 13% | |||
Accounts receivable | Customer B | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 16% | 13% | |||
Accounts receivable | Customer C | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 7% | 2% | |||
Accounts receivable | Customer D | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 6% | 2% | |||
Accounts receivable | Other | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 20% | 7% |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Anti-Dilutive Common Shares Equivalents Outstanding (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,869,493 | 2,446,657 | 2,784,799 | 2,901,595 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 2,627,704 | 2,446,657 | 2,546,760 | 2,777,995 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 241,789 | 0 | 238,039 | 123,600 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net (Loss) Earnings (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator | ||||
Basic earnings (loss) per share-net (loss) earnings | $ (7,131) | $ (5,622) | $ 27,477 | $ (2,431) |
Diluted earnings (loss) per share-net (loss) earnings | $ (7,131) | $ (5,622) | $ 27,477 | $ (2,431) |
Denominator | ||||
Basic weighted average common shares outstanding (in shares) | 13,166,931 | 13,077,298 | 12,906,235 | 13,103,203 |
Dilutive effect of stock options (in shares) | 0 | 0 | 145,076 | 0 |
Diluted weighted average common shares outstanding (in shares) | 13,166,931 | 13,077,298 | 13,051,311 | 13,103,203 |
Basic net (loss) earnings per share | ||||
Basic net (loss) earnings per share (in dollars per share) | $ (0.54) | $ (0.43) | $ 2.13 | $ (0.19) |
Diluted net (loss) earnings per share | ||||
Diluted net (loss) earnings per share (in dollars per share) | $ (0.54) | $ (0.43) | $ 2.11 | $ (0.19) |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | $ 7,760 | $ 7,760 | $ 7,591 | ||
Less accumulated depreciation | (6,463) | (6,463) | (5,955) | ||
Property and equipment, net | 1,297 | 1,297 | 1,636 | ||
Depreciation expense | 200 | $ 200 | 500 | $ 600 | |
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 1,525 | $ 1,525 | 1,525 | ||
Estimated Useful Life (years) | 7 years | ||||
Office equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 1,077 | $ 1,077 | 1,077 | ||
Estimated Useful Life (years) | 3 years | ||||
Equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | 4,003 | $ 4,003 | 3,834 | ||
Estimated Useful Life (years) | 7 years | ||||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property, plant and equipment, gross | $ 1,155 | $ 1,155 | $ 1,155 | ||
Estimated Useful Life (years) | 2 years |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Business Acquisition [Line Items] | ||
Raw materials | $ 9,704 | $ 7,317 |
Work in process | 21,246 | 9,666 |
Finished products | 32,905 | 4,925 |
Total inventories | 63,855 | $ 21,908 |
Acacia Pharma | ||
Business Acquisition [Line Items] | ||
Raw materials | 1,700 | |
Work in process | 2,900 | |
Finished products | $ 21,800 |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid income taxes | $ 566 | $ 1,173 |
Prepaid FDA user fee and advances to clinical research organization | 0 | 1,108 |
Prepaid insurance | 537 | 196 |
Advances to commercial manufacturers | 3,164 | 2,354 |
Prepaid R&D | 1,445 | 0 |
Convertible promissory note, net | 0 | 5,312 |
Other receivable related to cost sharing arrangement with commercial partner | 998 | 347 |
All other | 2,165 | 1,400 |
Total prepaid expenses and other current assets | $ 8,875 | $ 11,890 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued product sales reserves | $ 21,662 | $ 4,390 |
Income taxes payable | 5,750 | 0 |
Royalties payable to commercial partners | 9,724 | 5,085 |
Accrued salary and other compensation | 3,702 | 8,466 |
Accrued professional fees | 7,622 | 2,013 |
Accrued research & development | $ 4,233 | $ 4,100 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total accrued expenses | Total accrued expenses |
Current portion of lease liability | $ 1,508 | $ 1,309 |
Inventory received but not invoiced | 14,431 | 6,177 |
Forward liability | 4,063 | 0 |
Accrued other | 957 | 798 |
Total accrued expenses | $ 73,652 | $ 32,338 |
Balance Sheet Accounts - Narrat
Balance Sheet Accounts - Narrative (Details) | Sep. 30, 2022 |
Balance Sheet Related Disclosures [Abstract] | |
Lessee, operating lease, remaining lease term | 2 years 3 months 18 days |
Lessee, operating lease, renewal term | 5 years |
Balance Sheet Accounts - Lease
Balance Sheet Accounts - Lease Related Disclosures (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |||||
Operating lease cost | $ 400 | $ 300 | $ 1,173 | $ 1,000 | $ 1,407 |
Total lease cost | 1,173 | 1,407 | |||
Cash paid for amounts included in the measurement of lease liabilities | |||||
Operating cash flows for operating leases | 1,173 | 1,407 | |||
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 0 | $ 270 | |||
Weighted-average remaining lease term - operating leases | 2 years 3 months 18 days | 2 years 3 months 18 days | 3 years 1 month 6 days | ||
Weighted-average discount rate - operating leases | 6% | 6% | 6% |
Balance Sheet Accounts - Future
Balance Sheet Accounts - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Classification as of September 30, 2022: | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | Accrued Liabilities, Current |
Current lease liabilities (included with Accrued expenses and other liabilities) | $ 1,508 | $ 1,309 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other long-term liabilities | |
Long-term lease liabilities (included with Other long-term liabilities) | $ 1,874 | |
Total lease liabilities | $ 3,382 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Gross Carrying Amount | $ 119,750 | $ 119,750 | $ 23,850 | |||
Accumulated Amortization | (10,965) | (10,965) | (13,179) | |||
Total | 108,785 | 108,785 | 10,671 | |||
Amortization expense of intangible assets | 3,700 | $ 700 | $ 5,886 | $ 2,118 | ||
Barhemsys intangible | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Useful Life (In Years) | 9 years | |||||
Gross Carrying Amount | 68,000 | $ 68,000 | ||||
Accumulated Amortization | (2,425) | (2,425) | ||||
Total | 65,575 | $ 65,575 | ||||
Byfavo intangible | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Useful Life (In Years) | 9 years | |||||
Gross Carrying Amount | 36,000 | $ 36,000 | ||||
Accumulated Amortization | (1,193) | (1,193) | ||||
Total | 34,807 | $ 34,807 | ||||
Ryanodex intangible | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Useful Life (In Years) | 9 years | 9 years | ||||
Gross Carrying Amount | 15,000 | $ 15,000 | 15,000 | |||
Accumulated Amortization | (6,821) | (6,821) | (5,079) | |||
Total | 8,179 | $ 8,179 | 9,921 | |||
Vasopressin milestone (3) | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Useful Life (In Years) | 1 year | 1 year | ||||
Gross Carrying Amount | 750 | $ 750 | 750 | |||
Accumulated Amortization | (526) | (526) | 0 | |||
Total | $ 224 | $ 224 | 750 | |||
Developed technology | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Useful Life (In Years) | 5 years | |||||
Gross Carrying Amount | 8,100 | |||||
Accumulated Amortization | (8,100) | |||||
Total | $ 0 |
Intangible Assets, Net - Sche_2
Intangible Assets, Net - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Estimated Amortization Expense | ||
2022 (remainder) | $ 3,690 | |
2023 | 14,405 | |
2024 | 14,127 | |
2025 | 13,886 | |
2026 | 11,584 | |
Thereafter | 51,093 | |
Total | $ 108,785 | $ 10,671 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 71 Months Ended | ||||
Sep. 24, 2020 | Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2022 | Sep. 23, 2020 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Payments to repurchase stock | $ 18,004,000 | $ 12,568,000 | ||||||
Award vesting period | 4 years | |||||||
Volatility | 46.83% | 56.07% | ||||||
Expected term (in years) | 5 years 9 months 3 days | 5 years 8 months 4 days | ||||||
Expected dividend yield | 0% | 0% | ||||||
PSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 228,200 | 159,000 | ||||||
Risk-free interest rate | 1.60% | |||||||
Volatility | 41% | |||||||
Expected term (in years) | 3 years | |||||||
Expected dividend yield | 0% | |||||||
S&P Biotechnology | PSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 228,200 | |||||||
S&P Biotechnology | PSUs | Chief Executive Officer | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted average grant date fair value (in dollars per share) | $ 70.45 | |||||||
S&P Biotechnology | PSUs | Other Executives | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted average grant date fair value (in dollars per share) | $ 53.43 | |||||||
March 2020 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock repurchase program, authorized amount | $ 160,000,000 | |||||||
Accelerated share repurchases, authorized amount | $ 25,000,000 | |||||||
Accelerated share repurchases, payment | $ 25,000,000 | |||||||
Accelerated share repurchases, shares received (in shares) | 550,623 | |||||||
Accelerated share repurchases, initial price paid per share (in dollars per share) | $ 45.40 | |||||||
Fair value adjustments related to derivative instruments | $ 3,000,000 | |||||||
Share Repurchase Programs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares of common stock repurchased (in shares) | 4,552,730 | |||||||
Payments to repurchase stock | $ 246,100,000 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Summary of Stock Options, RSU and PSU Activity (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock Options | ||
Outstanding beginning balance (in shares) | 2,814,878 | 3,331,890 |
Granted (in shares) | 123,700 | 109,000 |
Options Exercised (in shares) | (91,255) | (100,477) |
Forfeited or expired (in shares) | (73,983) | (308,815) |
Outstanding ending balance (in shares) | 2,773,340 | 3,031,598 |
RSUs | ||
RSUs and PSUs | ||
Outstanding beginning balance (in shares) | 263,306 | 328,396 |
Granted (in shares) | 148,000 | 106,600 |
Vested (in shares) | (101,898) | (94,273) |
Forfeited or expired (in shares) | (36,616) | (46,941) |
Outstanding ending balance (in shares) | 272,792 | 293,782 |
PSUs | ||
RSUs and PSUs | ||
Outstanding beginning balance (in shares) | 137,300 | 97,750 |
Granted (in shares) | 228,200 | 159,000 |
Vested (in shares) | 0 | 0 |
Forfeited or expired (in shares) | (46,400) | (97,750) |
Outstanding ending balance (in shares) | 319,100 | 159,000 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Compensation - Fair Value of Stock Options Granted (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest minimum rate | 1.47% | 0.51% | ||
Risk-free interest maximum rate | 3.66% | 1.12% | ||
Volatility | 46.83% | 56.07% | ||
Expected term (in years) | 5 years 9 months 3 days | 5 years 8 months 4 days | ||
Expected dividend yield | 0% | 0% | ||
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest minimum rate | 2.83% | 0.82% | ||
Risk-free interest maximum rate | 3.66% | 0.93% | ||
Volatility | 46.69% | 54.92% | ||
Expected term (in years) | 6 years 29 days | 6 years 29 days | ||
Expected dividend yield | 0% | 0% |
Common Stock and Stock-Based _6
Common Stock and Stock-Based Compensation - Schedule of Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 3,537 | $ 4,084 | $ 12,332 | $ 14,873 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 2,937 | 3,443 | 10,488 | 12,696 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 600 | 641 | 1,844 | 2,177 |
Stock options | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,597 | 2,515 | 5,131 | 8,393 |
RSUs | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 989 | 1,046 | 3,913 | 4,051 |
PSUs | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 951 | $ 523 | $ 3,288 | $ 2,429 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Aug. 31, 2022 | |
Operating lease | ||||||
Total | $ 3,621 | $ 3,621 | ||||
2022 | 414 | 414 | ||||
2023 | 1,672 | 1,672 | ||||
2024 | 1,122 | 1,122 | ||||
2025 | 413 | 413 | ||||
Beyond | 0 | 0 | ||||
Credit facility | ||||||
Total | 59,324 | 59,324 | ||||
2022 | 35,000 | 35,000 | ||||
2023 | 4,257 | 4,257 | ||||
2024 | 12,162 | 12,162 | ||||
2025 | 7,905 | 7,905 | ||||
Beyond | 0 | 0 | ||||
Required contractual investment in Enalare | ||||||
Total | 12,500 | 12,500 | ||||
2022 | 0 | 0 | ||||
2023 | 12,500 | 12,500 | ||||
2024 | 0 | 0 | ||||
2025 | 0 | 0 | ||||
Beyond | 0 | 0 | ||||
Purchase obligations | ||||||
Total | 99,403 | 99,403 | ||||
2022 | 99,403 | 99,403 | ||||
2023 | 0 | 0 | ||||
2024 | 0 | 0 | ||||
2025 | 0 | 0 | ||||
Beyond | 0 | 0 | ||||
Total obligations | ||||||
Total | 174,848 | 174,848 | ||||
2022 | 134,817 | 134,817 | ||||
2023 | 18,429 | 18,429 | ||||
2024 | 13,284 | 13,284 | ||||
2025 | 8,318 | 8,318 | ||||
Beyond | 0 | 0 | ||||
Operating lease cost | 400 | $ 300 | 1,173 | $ 1,000 | $ 1,407 | |
Long-Term Purchase Commitment [Line Items] | ||||||
Purchase obligation | 99,403 | 99,403 | ||||
Investment in Enalare Therapeutics, Inc. | ||||||
Long-Term Purchase Commitment [Line Items] | ||||||
Investments | $ 12,500 | |||||
Collaborative Arrangement | ||||||
Purchase obligations | ||||||
Total | 99,400 | 99,400 | ||||
Long-Term Purchase Commitment [Line Items] | ||||||
Purchase obligation | $ 99,400 | $ 99,400 |
Debt - Narrative (Details)
Debt - Narrative (Details) € in Millions | 3 Months Ended | 9 Months Ended | |||||
Nov. 01, 2022 USD ($) | Nov. 08, 2019 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 09, 2022 EUR (€) tranche | Dec. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||||
Proceeds from lines of credit | $ 15,000,000 | $ 0 | |||||
Current debt | $ 34,961,000 | 34,961,000 | $ 25,607,000 | ||||
Unamortized deferred debt issuance cost | 100,000 | $ 100,000 | |||||
Revised Credit Agreement | London Interbank Offered Rate (LIBOR) | |||||||
Debt Instrument [Line Items] | |||||||
Variable interest rate spread (as a percent) | 1% | ||||||
Amendment Credit Agreement | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.35% | ||||||
Amendment Credit Agreement | Minimum | London Interbank Offered Rate (LIBOR) | |||||||
Debt Instrument [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2.25% | ||||||
Amendment Credit Agreement | Minimum | Prime Rate | |||||||
Debt Instrument [Line Items] | |||||||
Variable interest rate spread (as a percent) | 1.25% | ||||||
Amendment Credit Agreement | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.45% | ||||||
Amendment Credit Agreement | Maximum | London Interbank Offered Rate (LIBOR) | |||||||
Debt Instrument [Line Items] | |||||||
Variable interest rate spread (as a percent) | 3% | ||||||
Amendment Credit Agreement | Maximum | Prime Rate | |||||||
Debt Instrument [Line Items] | |||||||
Variable interest rate spread (as a percent) | 2% | ||||||
Third Amended and Restated Credit Agreement | Subsequent event | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from lines of credit | $ 35,400,000 | ||||||
Third Amended and Restated Credit Agreement | Line of credit | Subsequent event | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | $ 50,000,000 | ||||||
Third Amended and Restated Credit Agreement | Line of credit | Minimum | Subsequent event | |||||||
Debt Instrument [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.35% | ||||||
Third Amended and Restated Credit Agreement | Line of credit | Maximum | Subsequent event | |||||||
Debt Instrument [Line Items] | |||||||
Line of credit facility, commitment fee (as a percent) | 0.45% | ||||||
Secured Debt | 2022 Term Loan | Line of credit | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | € | € 25 | ||||||
Number of tranches | tranche | 2 | ||||||
Secured Debt | 2022 Term Loan, Tranche A | Line of credit | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | € | € 15 | ||||||
Stated interest rate (as a percent) | 9% | ||||||
Secured Debt | 2022 Term Loan, Tranche B | Line of credit | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | € | € 10 | ||||||
Stated interest rate (as a percent) | 9% | ||||||
Line of credit | Revised Credit Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from lines of credit | $ 40,000,000 | ||||||
Revolving credit facility | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from lines of credit | $ 15,000,000 | ||||||
Revolving credit facility | Revised Credit Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | $ 110,000,000 | ||||||
Revolving credit facility | Third Amended and Restated Credit Agreement | Line of credit | Subsequent event | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | $ 100,000,000 | ||||||
Current borrowing capacity | $ 15,000,000 |
Debt - Schedule of Debt Maturit
Debt - Schedule of Debt Maturities (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Maturities | |
2022 (remainder) | $ 35,000 |
2023 | 4,257 |
2024 | 12,162 |
2025 | 7,905 |
Total | $ 59,324 |
Income Taxes (Details)
Income Taxes (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) jurisdiction | Sep. 30, 2021 USD ($) | |
Income Tax Disclosure [Abstract] | ||||
Income tax (provision) benefit | $ (3,468,000) | $ 7,038,000 | $ (20,652,000) | $ 3,341,000 |
Effective tax rate | (95.00%) | 56% | 43% | 58% |
Number of tax jurisdictions currently auditing the company | jurisdiction | 3 | |||
Unrecognized tax benefits | $ 0 | $ 0 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Aug. 31, 2021 | Jan. 07, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Fair value gain (loss) on equity investment | $ (3,208,000) | $ (1,900,000) | ||||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Combioxin | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Collaborative arrangement, rights and obligations, upfront payment | $ 10,000,000 | |||||
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments | 105,000,000 | |||||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | AOP Orphan Pharmaceuticals GmbH | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Collaborative arrangement, rights and obligations, upfront payment | 5,000,000 | |||||
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments | $ 25,000,000 | |||||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Tyme | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Co-promotion agreement, percentage of promotional sales effort responsible for | 25% | |||||
Co-promotion agreement, percentage of net revenue receivable | 15% | |||||
Co-promotion agreement, percentage of net revenue receivable due to collaborator | 85% | |||||
Co-promotion agreement, right to repurchase, amount | $ 200,000,000 | |||||
Fair value gain (loss) on equity investment | $ 22,000 | $ (2,300,000) | $ (3,200,000) | $ (1,900,000) |
Convertible Promissory Note (De
Convertible Promissory Note (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Embedded Derivative, beginning balance | $ 962,000 | ||||
Total in Other Current Assets, beginning balance | 5,312,000 | ||||
Fair Value Adjustments to the note | $ (510,000) | $ 22,000 | 94,000 | $ (882,000) | |
Total in Other Current Assets, ending balance | 0 | 0 | |||
Convertible Promissory Note | |||||
Debt Securities, Available-for-sale [Line Items] | |||||
Debt securities, available-for-sale | $ 5,000,000 | ||||
Stated interest rate (as a percent) | 8% | ||||
Term | 18 months | ||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Fair value of the note, beginning balance | 5,510,000 | 4,906,000 | |||
Discount on the note, beginning balance | (36,000) | (127,000) | |||
Estimated Credit Loss, beginning balance | (820,000) | (758,000) | |||
Convertible Promissory Note, net, beginning balance | 4,654,000 | 4,021,000 | |||
Embedded Derivative, beginning balance | 1,026,000 | 962,000 | |||
Interest Receivable, beginning balance | 530,000 | 329,000 | |||
Fair Value Adjustments to the note | (5,510,000) | (4,906,000) | |||
Accretion of Discount | 0 | 127,000 | |||
Interest Income | 0 | ||||
Fair Value Adjustment to Embedded Derivative | (1,026,000) | (962,000) | |||
Fair value of the note, ending balance | 0 | 0 | |||
Discount on the note, ending balance | 0 | 0 | |||
Estimated Credit Loss, ending balance | 0 | 0 | |||
Convertible Promissory Note, net, ending balance | 0 | 0 | |||
Embedded Derivative, ending balance | 0 | 0 | |||
Interest Receivable, ending balance | 0 | 0 | |||
Convertible Promissory Note | Other Current Assets | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Total in Other Current Assets, beginning balance | 6,210,000 | 5,312,000 | |||
Fair Value Adjustments to the note | (5,474,000) | (4,906,000) | |||
Accretion of Discount | 0 | 127,000 | |||
Estimated Credit Loss | 290,000 | 429,000 | |||
Interest Income | 0 | 0 | |||
Fair Value Adjustment to Embedded Derivative | (1,026,000) | (962,000) | |||
Total in Other Current Assets, ending balance | 0 | 0 | |||
Convertible Promissory Note | Valuation, Estimated Credit Loss | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Estimated Credit Loss | 820,000 | 758,000 | |||
Convertible Promissory Note | Convertible Promissory Note, Net | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Fair Value Adjustments to the note | (5,474,000) | ||||
Estimated Credit Loss | 820,000 | 758,000 | |||
Convertible Promissory Note | Reclassification, Other | |||||
Debt Securities, Available-for-sale, Allowance for Credit Loss [Roll Forward] | |||||
Fair Value Adjustments to the note | 36,000 | ||||
Estimated Credit Loss | $ (530,000) | $ (329,000) |
Business Acquisition (Details)
Business Acquisition (Details) $ / shares in Units, $ in Thousands, € in Millions | 3 Months Ended | 4 Months Ended | 9 Months Ended | |||
Jun. 09, 2022 EUR (€) shares | Jun. 09, 2022 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | |
Business Acquisition [Line Items] | ||||||
Goodwill, measurement period adjustments | $ 1,300 | |||||
Goodwill period decrease | $ 3,300 | |||||
Acacia Pharma | ||||||
Business Acquisition [Line Items] | ||||||
Cash consideration | € 94.7 | $ 76,708 | ||||
Cash consideration per share (in euros per share) | $ / shares | $ 0.90 | |||||
Number of shares issued in business acquisition (in shares) | shares | 516,024 | 516,024 | ||||
Cash paid per acquiree share (in euros per share) | $ / shares | $ 0.68 | |||||
Number of company stock for each share of Acacia Pharma common stock converted (in shares) | shares | 0.0049 | 0.0049 | ||||
Fair value of consideration | $ 100,353 | |||||
Acquisition related expenses | $ 1,100 | $ 12,400 | ||||
Revenue from acquiree since acquisition | $ 900 | |||||
Earnings (loss) from acquiree since acquisition | $ (15,500) |
Business Acquisition - Summary
Business Acquisition - Summary of Fair Value of Consideration (Details) - Jun. 09, 2022 - Acacia Pharma $ in Thousands, € in Millions | EUR (€) | USD ($) |
Business Acquisition [Line Items] | ||
Cash consideration | € 94.7 | $ 76,708 |
Fair value of consideration | 100,353 | |
Common Stock | ||
Business Acquisition [Line Items] | ||
Fair value of Eagle common stock issued | $ 23,645 |
Business Acquisition - Prelimin
Business Acquisition - Preliminary Allocation of Purchase Price to Estimated Fair Values of Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jun. 09, 2022 | Dec. 31, 2021 |
Business Acquisition [Line Items] | |||
Goodwill | $ 41,794 | $ 39,743 | |
Acacia Pharma | |||
Business Acquisition [Line Items] | |||
Cash | $ 2,556 | ||
Net working capital, excluding cash | (2,158) | ||
Inventory | 26,942 | ||
Intangible assets | 104,000 | ||
Debt | (28,503) | ||
Deferred tax liability, net | (4,536) | ||
Fair value of net assets acquired | 98,301 | ||
Goodwill | 3,315 | ||
Fair value of assets acquired, including goodwill | $ 101,616 |
Business Acquisition - Pro Form
Business Acquisition - Pro Forma Financial Information (Details) - Acacia Pharma - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Business Acquisition, Pro Forma Information, Nonrecurring Adjustment [Line Items] | ||||
Total revenue | $ 65,901 | $ 48,400 | $ 257,093 | $ 90,090 |
Net (loss) income | $ (7,131) | $ (14,905) | $ 10,752 | $ (41,471) |
Investment in Enalare Therape_3
Investment in Enalare Therapeutics Inc. - Narratives (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Aug. 08, 2022 |
Schedule of Equity Method Investments [Line Items] | ||
Investment in contractual obligation within another six months | $ 12,500 | |
Enlare Therapeutics Inc. | ||
Schedule of Equity Method Investments [Line Items] | ||
Committed equity investment | $ 30,000 |
Investment in Enalare Therape_4
Investment in Enalare Therapeutics Inc. - Schedule of Equity Method Investments (Details) $ in Thousands | 3 Months Ended |
Sep. 30, 2022 USD ($) | |
Equity Method Investments [Roll Forward] | |
Acquisition Rights (Other assets), ending balance | $ 8,125 |
Forward Liability (Accrued expenses and other liabilities, ending balance | (4,063) |
Enlare Therapeutics Inc. | |
Equity Method Investments [Roll Forward] | |
Beginning balance as of June 30, 2022 | 0 |
Adjustments | 0 |
Ending balance as of September 30, 2022 | 12,500 |
Investment in Enalare Therapeutics, Inc. | |
Equity Method Investments [Roll Forward] | |
Non-RDFV Investment (Other assets), beginning balance | 0 |
Non-RDFV Investment (Other assets), additions during period | 8,438 |
Non-RDFV Investment (Other assets), ending balance | 8,438 |
Acquisition Rights (Other assets), beginning balance | 0 |
Acquisition Rights (Other assets), additions during period | 8,125 |
Acquisition Rights (Other assets), ending balance | 8,125 |
Forward Liability (Accrued expenses and other liabilities, beginning balance | 0 |
Forward Liability (Accrued expenses and other liabilities, additions during period | (4,063) |
Forward Liability (Accrued expenses and other liabilities, ending balance | (4,063) |
Additions during period | $ 12,500 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 11 Months Ended | 25 Months Ended | ||
Nov. 01, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2023 | Oct. 31, 2025 | |
Subsequent Event [Line Items] | ||||||
Proceeds from lines of credit | $ 15,000,000 | $ 0 | ||||
Revolving credit facility | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from lines of credit | $ 15,000,000 | |||||
Subsequent event | Third Amended and Restated Credit Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from lines of credit | $ 35,400,000 | |||||
Subsequent event | Third Amended and Restated Credit Agreement | Revolving credit facility | ||||||
Subsequent Event [Line Items] | ||||||
Long-term line of credit | 15,000,000 | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Maximum borrowing capacity | $ 50,000,000 | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Minimum | ||||||
Subsequent Event [Line Items] | ||||||
Line of credit facility, commitment fee (as a percent) | 0.35% | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Minimum | Secured Overnight Financing Rate (SOFR) | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate spread (as a percent) | 2.50% | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Minimum | New York Federal Reserve Bank (NYFRB) | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate spread (as a percent) | 1.50% | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Maximum | ||||||
Subsequent Event [Line Items] | ||||||
Line of credit facility, commitment fee (as a percent) | 0.45% | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Maximum | Secured Overnight Financing Rate (SOFR) | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate spread (as a percent) | 3.25% | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Maximum | New York Federal Reserve Bank (NYFRB) | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate spread (as a percent) | 2.25% | |||||
Subsequent event | Line of credit | Third Amended and Restated Credit Agreement | Revolving credit facility | ||||||
Subsequent Event [Line Items] | ||||||
Maximum borrowing capacity | $ 100,000,000 | |||||
Long-term line of credit | 15,000,000 | |||||
Subsequent event | 2022 Term Loan | Third Amended and Restated Credit Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Long-term line of credit | $ 50,000,000 | |||||
Installment payment amount | $ 1,250,000 | $ 2,500,000 |