Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 19, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ATNX | ||
Entity Registrant Name | ATHENEX, INC. | ||
Entity Central Index Key | 0001300699 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Common Stock, Shares Outstanding | 93,454,700 | ||
Entity Public Float | $ 702 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity File Number | 001-38112 | ||
Entity Tax Identification Number | 43-1985966 | ||
Entity Address, Address Line One | 1001 Main Street | ||
Entity Address, Address Line Two | Suite 600 | ||
Entity Address, City or Town | Buffalo | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 14203 | ||
City Area Code | 716 | ||
Local Phone Number | 427-2950 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | true | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement for its 2021 annual meeting of stockholders currently scheduled to be held on June 4, 2021 are incorporated by reference into Part III Items 10, 11, 12, 13 and 14 of this Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 69,587 | $ 127,674 |
Restricted cash | 16,500 | |
Short-term investments | 138,636 | 33,139 |
Accounts receivable, net of chargebacks and other deductions of $12,552 and $14,394, respectively, and provision for credit losses of $9,637 and $124, respectively | 23,603 | 16,689 |
Inventories | 28,846 | 32,630 |
Prepaid expenses and other current assets | 14,789 | 20,794 |
Total current assets | 291,961 | 230,926 |
Property and equipment, net | 34,388 | 23,153 |
Goodwill | 38,891 | 38,513 |
Intangible assets, net | 10,218 | 8,522 |
Operating lease right-of-use assets, net | 7,921 | 8,818 |
Other assets | 950 | |
Total assets | 384,329 | 309,932 |
Current liabilities: | ||
Accounts payable | 18,673 | 23,331 |
Accrued expenses | 38,273 | 44,307 |
Current portion of operating lease liabilities | 3,185 | 3,010 |
Current portion of long-term debt and finance lease obligations | 2,010 | 880 |
Total current liabilities | 62,141 | 71,528 |
Long-term liabilities: | ||
Long-term operating lease liabilities | 6,355 | 7,620 |
Long-term debt and finance lease obligations | 146,577 | 52,366 |
Deferred tax liabilities | 56 | |
Other long-term liabilities | 3,852 | 2,563 |
Total liabilities | 218,981 | 134,077 |
Commitments and contingencies (Note 20) | ||
Stockholders' equity: | ||
Common stock, par value $0.001 per share, 250,000,000 shares authorized at December 31, 2020 and 2019; 95,066,195 and 83,231,063 shares issued at December 31, 2020 and 2019, respectively; 93,393,275 and 81,558,143 shares outstanding at December 31, 2020 and 2019, respectively | 95 | 83 |
Additional paid-in capital | 901,864 | 763,648 |
Accumulated other comprehensive loss | (1,134) | (635) |
Accumulated deficit | (713,644) | (567,465) |
Less: treasury stock, at cost; 1,672,920 shares at December 31, 2020 and 2019 | (7,406) | (7,406) |
Total Athenex, Inc. stockholders' equity | 179,775 | 188,225 |
Non-controlling interests | (14,427) | (12,370) |
Total stockholders' equity | 165,348 | 175,855 |
Total liabilities and stockholders' equity | $ 384,329 | $ 309,932 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable, chargebacks and other deductions (in dollars) | $ 12,552 | $ 14,394 |
Provision for credit losses (in dollars) | $ 9,637 | $ 124 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 95,066,195 | 83,231,063 |
Common Stock, shares outstanding | 93,393,275 | 81,558,143 |
Treasury stock, shares | 1,672,920 | 1,672,920 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | |||
Total revenue | $ 144,391 | $ 101,229 | $ 89,100 |
Cost of sales | 95,355 | 69,619 | 47,005 |
Gross profit | 49,036 | 31,610 | 42,095 |
Operating expenses: | |||
Research and development expenses | 75,904 | 84,393 | 119,905 |
Selling, general, and administrative expenses | 96,855 | 66,749 | 49,008 |
Total operating expenses | 172,759 | 151,142 | 168,913 |
Operating loss | (123,723) | (119,532) | (126,818) |
Interest income | (874) | (1,881) | (1,788) |
Interest expense | 11,219 | 6,954 | 3,581 |
Loss on extinguishment of debt | 10,278 | ||
Loss before income tax expense | (144,346) | (124,605) | (128,611) |
Income tax expense | 4,088 | 928 | 100 |
Net loss | (148,434) | (125,533) | (128,711) |
Less: net loss attributable to non-controlling interests | (2,255) | (1,784) | (11,271) |
Net loss attributable to Athenex, Inc. | (146,179) | (123,749) | (117,440) |
Unrealized (loss) gain on investment, net of income taxes | (5) | (97) | 15 |
Foreign currency translation adjustment, net of income taxes | (494) | 118 | (525) |
Comprehensive loss | $ (146,678) | $ (123,728) | $ (117,950) |
Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted (Note 15) | $ (1.72) | $ (1.67) | $ (1.82) |
Weighted-average shares used in computing net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted (Note 15) | 85,082,868 | 74,054,261 | 64,590,270 |
Product Sales, Net | |||
Revenue: | |||
Total revenue | $ 105,274 | $ 80,535 | $ 56,394 |
License and Other Revenue | |||
Revenue: | |||
Total revenue | $ 39,117 | $ 20,694 | $ 32,706 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Treasury Stock | Total Athenex, Inc. Stockholders' Equity | Non-Controlling Interests |
Beginning balance at Dec. 31, 2017 | $ 90,722 | $ 60 | $ 423,805 | $ (326,276) | $ (146) | $ (7,406) | $ 90,037 | $ 685 |
Beginning balance, shares at Dec. 31, 2017 | 59,894,362 | (1,672,920) | ||||||
Sale of common stock | 117,616 | $ 7 | 117,609 | 117,616 | ||||
Sale of common stock, shares | 7,486,261 | |||||||
Issuance of warrant, net | 3,140 | 3,140 | 3,140 | |||||
Stock-based compensation cost | 10,003 | 10,003 | 10,003 | |||||
Vesting of restricted stock | 1,008 | $ 1 | 1,007 | 1,008 | ||||
Vesting of restricted stock, shares | 240,000 | |||||||
Stock options and warrants exercised | 3,956 | $ 1 | 3,955 | 3,956 | ||||
Stock options and warrants exercised, shares | 673,230 | |||||||
Research and development licensing fee satisfied with stock | 31,545 | 31,545 | 31,545 | |||||
Research and development licensing fee satisfied with stock, shares | 375,133 | |||||||
Net loss | (128,711) | (117,440) | (117,440) | (11,271) | ||||
Other comprehensive loss, net of tax | (510) | (510) | (510) | |||||
Ending balance at Dec. 31, 2018 | 128,769 | $ 69 | 591,064 | (443,716) | (656) | $ (7,406) | 139,355 | (10,586) |
Ending balance, shares at Dec. 31, 2018 | 68,668,986 | (1,672,920) | ||||||
Sale of common stock | 159,977 | $ 14 | 159,963 | 159,977 | ||||
Sale of common stock, shares | 14,006,575 | |||||||
Equity consideration in connection with acquisition | 748 | 748 | 748 | |||||
Stock-based compensation cost | 8,219 | 8,219 | 8,219 | |||||
Restricted stock expense | 1,671 | 1,671 | 1,671 | |||||
Restricted stock expense, shares | 223,723 | |||||||
Stock options exercised | 1,983 | 1,983 | 1,983 | |||||
Stock options exercised, shares | 331,779 | |||||||
Net loss | (125,533) | (123,749) | (123,749) | (1,784) | ||||
Other comprehensive loss, net of tax | 21 | 21 | 21 | |||||
Ending balance at Dec. 31, 2019 | 175,855 | $ 83 | 763,648 | (567,465) | (635) | $ (7,406) | 188,225 | (12,370) |
Ending balance, shares at Dec. 31, 2019 | 83,231,063 | (1,672,920) | ||||||
Sale of common stock | 119,110 | $ 11 | 119,099 | 119,110 | ||||
Sale of common stock, shares | 11,607,322 | |||||||
Issuance of warrant, net | 6,544 | 6,544 | 6,544 | |||||
Stock-based compensation cost | 9,833 | 9,833 | 9,833 | |||||
Restricted stock expense | 1,017 | 1,017 | 1,017 | |||||
Restricted stock expense, shares | (10,820) | |||||||
Stock options exercised | $ 1,724 | $ 1 | 1,723 | 1,724 | ||||
Stock options exercised, shares | 238,630 | 238,630 | ||||||
Non-controlling interests | $ 198 | 198 | ||||||
Net loss | (148,434) | (146,179) | (146,179) | (2,255) | ||||
Other comprehensive loss, net of tax | (499) | (499) | (499) | |||||
Ending balance at Dec. 31, 2020 | $ 165,348 | $ 95 | $ 901,864 | $ (713,644) | $ (1,134) | $ (7,406) | $ 179,775 | $ (14,427) |
Ending balance, shares at Dec. 31, 2020 | 95,066,195 | (1,672,920) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Stockholders Equity [Abstract] | |||
Stock issuance costs and discounts | $ 5,518 | ||
Stock issuance costs | $ 7,869 | $ 1,103 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | |||
Net loss | $ (148,434) | $ (125,533) | $ (128,711) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 4,492 | 3,817 | 3,269 |
Stock-based compensation expense | 10,850 | 9,885 | 11,011 |
Loss on extinguishment of debt | 10,278 | ||
Provision for credit losses | 9,513 | ||
Amortization of debt discount | 1,781 | 1,026 | 514 |
Deferred rent expense | 262 | ||
Net loss on disposal of assets and impairment charges | 222 | 232 | 236 |
Research and development license fees settled with convertible bond and stock | 31,545 | ||
Deferred income taxes | 56 | 486 | (365) |
Changes in operating assets and liabilities, net of effect of acquisition: | |||
Receivables, net | (16,427) | (3,738) | (4,483) |
Prepaid expenses and other assets | 5,702 | 864 | (13,966) |
Inventories | 3,784 | (3,844) | (12,226) |
Accounts payable and accrued expenses | (13,060) | 19,345 | 3,527 |
Net cash used in operating activities | (131,243) | (97,460) | (109,387) |
Cash flows from investing activities: | |||
Purchase of property and equipment | (13,256) | (13,572) | (3,321) |
Payments for licenses | (214) | (4,175) | (110) |
Acquisition activity | 853 | ||
Purchases of short-term investments | (161,847) | (74,697) | (113,259) |
Sale of short-term investments | 56,345 | 99,090 | 67,727 |
Net cash (used in) provided by investing activities | (118,972) | 7,499 | (48,963) |
Cash flows from financing activities: | |||
Proceeds from sale of stock | 126,980 | 161,080 | 123,134 |
Proceeds from issuance of debt | 145,126 | 6,464 | 50,000 |
Proceeds from issuance of warrants | 7,039 | ||
Costs incurred related to the sale of stock | (7,869) | (1,103) | (5,518) |
Costs incurred related to the issuance of debt and warrants | (9,363) | (1,993) | |
Proceeds from exercise of stock options | 1,723 | 1,983 | 3,956 |
Investment from non-controlling interest | 198 | ||
Repayment of finance lease obligations and long-term debt | (54,407) | (972) | (544) |
Net cash provided by financing activities | 209,427 | 167,452 | 169,035 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (40,788) | 77,491 | 10,685 |
Cash, cash equivalents, and restricted cash beginning of period | 127,674 | 49,794 | 39,284 |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (799) | 389 | (175) |
Cash, cash equivalents, and restricted cash, end of period (See Note 3) | 86,087 | 127,674 | 49,794 |
Supplemental cash flow disclosures | |||
Interest paid | 6,056 | 4,925 | 2,977 |
Income taxes paid | 3,066 | 448 | 464 |
Non-cash investing and financing activities: | |||
Accrued purchases of property and equipment | 478 | 483 | 340 |
Accrued cost of debt issuance | 750 | ||
Common stock issued in lieu of licensing cash payment | 31,545 | ||
Property and equipment financed under capital and finance leases | 848 | ||
Accrued purchases of licenses | 2,850 | $ 4,175 | |
ROU assets derecognized from modification of operating lease obligations | $ (468) | ||
Equity consideration in connection with acquisition | $ 748 |
Company and Nature of Business
Company and Nature of Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Company and Nature of Business | 1. Description of Business Athenex, Inc. (the “Company” or “Athenex”), originally under the name Kinex Pharmaceuticals LLC (“Kinex”), formed in November 2003, commenced operations on February 5, 2004, and operated as a limited liability company until it was incorporated in the State of Delaware under the name Kinex Pharmaceuticals, Inc. on December 31, 2012. The Company changed its name to Athenex, Inc. on August 26, 2015. Athenex is a global biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of novel therapies for the treatment of cancer. The Company’s mission is to improve the lives of cancer patients by creating more effective, safer and tolerable treatments. The Company’s current clinical pipeline is derived from Orascovery, based on a P-glycoprotein (“P-gp”) pump inhibitor, Src Kinase inhibition, T-cell receptor-engineered T-cells (“TCR-T”), and arginine deprivation therapy technology platforms. The Company has assembled a strong and experienced leadership team and has established global operations across the pharmaceutical value chain to execute its goal of becoming a global leader in bringing innovative cancer treatments to the market and improve health outcomes. The Company is primarily engaged in conducting research and development activities through corporate collaborators, in-licensing and out-licensing pharmaceutical compounds and technology, conducting preclinical and clinical testing, recruiting personnel, identifying and evaluating additional drug candidates for potential in-licensing or acquisition, and raising capital to support development and commercialization activities. The Company also conducts commercial sales of specialty products through its wholly owned subsidiary, Athenex Pharmaceutical Division (“APD”), and 503B products through its wholly owned subsidiary, Athenex Pharma Solutions (“APS”). Recent Financing Public Offering of Stock In September 2020, the Company completed an underwritten follow-on public offering in which it sold 11,500,000 shares of its common stock, including 1,500,000 shares of common stock pursuant to underwriters’ option to purchase additional shares, at a public offering price of $11.00 per share and received net proceeds of $118.7 million, after deducting underwriting discounts and commissions and offering expenses of $7.9 million. In January 2018, the Company completed an underwritten public offering of 4,300,000 shares of its common stock. The Company granted the underwriters a 30-day option to purchase up to an additional 645,000 shares of common stock. In February 2018, the underwriters partially exercised their option, purchasing an additional 465,000 shares of common stock. All shares were offered by the Company at a price of $15.25 per share. The aggregate net proceeds were $68.1 million, net of underwriting discounts and commissions and offering expenses of $4.6 million. Revenue Interest Financing Agreement and Detachable Warrants On August 4, 2020, the Company entered into a Revenue Interest Financing Agreement with Sagard Healthcare Royalty Partners, LP (“Sagard”), pursuant to which Sagard agreed to pay the Company $50.0 million (the “Product Payment”) to provide funding for the Company’s development and commercialization of Oral Paclitaxel upon receipt of marketing authorization for Oral Paclitaxel by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic breast cancer. In exchange for the Product Payment, the Company agreed to make payments to Sagard (the “Payments”) equal to 5.0% of its world-wide net sales of Oral Paclitaxel, subject to a hard cap equal to the lesser of 170% of the Product Payment and the Put/Call Price set forth in the Revenue Interest Financing Agreement (the “Hard Cap”). The Company is required to make certain additional payments to Sagard to the extent Sagard has not received Payments equaling at least $20.0 million by September 30, 2024 and at least $50.0 million by August 4, 2026, in the amount of the applicable shortfall, and, subject to the Hard Cap, if Sagard has not received Payments equaling at least $85.0 million by the tenth anniversary of the date the Product Payment is funded, in an amount such that Sagard will have obtained a 6.0% internal rate of return on the Product Payment. Sagard and its co-investors OPB SHRP Co-Invest Credit Limited and SIMCOE SHRP Co-Invest Credit Ltd. (the “IMCO Investors”) also acquired by assignment (the “Assignment”) term loans and commitments equal to $50.0 million under the Senior Credit Agreement, as Senior Secured Loan Agreement and Detachable Warrants On June 19, 2020, the Company entered into a senior secured loan agreement and related security agreements (the “Senior Credit Agreement”) with Oaktree Fund Administration, LLC as administrative agent, and the lenders party thereto (collectively “Oaktree”) to borrow up to $225.0 million in five tranches with a maturity date of June 19, 2026, bearing interest at a fixed annual rate of 11.0%. The first tranche of $100.0 million was drawn by the Company prior to June 30, 2020, with the proceeds used in part to repay in full the outstanding loan and fees under the credit agreement with Perceptive Advisors LLC and its affiliates (“Perceptive”), which resulted in a loss on extinguishment of debt of $7.2 million. The second tranche of $25.0 million was drawn by the Company prior to September 30, 2020 and the third tranche of $25.0 million was drawn by the Company prior to December 31, 2020. Additional debt tranches of $75.0 million in aggregate are available subject to the Company’s achievement of certain regulatory and commercial milestones. The Company is required to make quarterly interest-only payments until June 19, 2022, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. The loan agreement contains specified financial maintenance covenants. The Company was in compliance with such covenants as of December 31, 2020. In connection with the Senior Credit A greement , the Company granted warrants to Oaktree to purchase an aggregate of up to 908,393 shares of the Company’s common stock at a purchase price of $12.63 per share. This transaction was accounted for as a detachable warrant at its fair value, using the relative fair value method, which is based on a number of unobservable inputs, and is recorded as an increase to additional paid-in-capital on the consolidated statement of stockholders’ equity. The fair value of the warrants was reflected as a discount to the term loan and amortized over the life of the term loan Debt and Equity Offering On July 3, 2018, the Company closed a privately placed debt and equity financing deal with Perceptive for gross proceeds of $100.0 million and received aggregate net proceeds of $97.1 million, net of fees and offering expenses. The Company entered into a 5-year senior secured loan for $50.0 million of this financing and issued 2,679,528 shares of its common stock at a purchase price of $18.66 per share for the remaining $50.0 million. The loan matures on the fifth anniversary from the closing date and bears interest at a floating per annum rate equal to London Interbank Offering Rates (“LIBOR”) (with a floor of 2.0%) plus 9.0%. The Company is required to make monthly interest-only payments with a bullet payment of the principal at maturity. The loan agreement contains specified financial maintenance covenants. The Company was in compliance with such covenants as of December 31, 2019 and 2018. On June 19, 2020, the Company paid off all obligations owing under, and terminated, the senior secured loan agreement with Perceptive. In connection with the loan agreement, the Company granted Perceptive a warrant for the purchase of 425,000 shares of common stock at a purchase price of $18.66 per share. This was accounted for as a detachable warrant at its fair value and is recorded as an increase to additional paid-in-capital on the consolidated statement of stockholders’ equity for the year ended December 31, 2018. A corresponding debt discount was recorded as a reduction of the related debt in the consolidated balance sheet as of December 31, 2018. Private Placements On December 9, 2019, the Company closed a private placement with a group of institutional investors, led by Kingdon Capital Management, LLC (collectively, the “Institutional Investors”), pursuant to which the Company sold an aggregate of 3,945,750 shares of its common stock to the Institutional Investors at a purchase price of $15.30 per share for aggregate net proceeds of $59.4 million, net of offering expenses of approximately $1.0 million. These shares were subsequently registered with the Securities and Exchange Commission (“SEC”) on January 28, 2020. On May 7, 2019, the Company closed a private placement with Perceptive Life Sciences Master Fund, Ltd., Avoro Capital Advisors (formerly known as venBio Select Fund LLC), OrbiMed Partners Master Fund Limited and the Biotech Growth Trust PLC (combined known as OrbiMed), (collectively, the “Investors”), pursuant to which the Company sold an aggregate of 10 million shares of its common stock to the Investors at a purchase price of $10.00 per share for aggregate net proceeds of $99.9 million, net of offering expenses of approximately $0.1 million. These shares were subsequently registered with the SEC on July 23, 2019. Significant Risks and Uncertainties The Company has incurred operating losses since its inception and, as a result, as of December 31, 2020 and December 31, 2019 had an accumulated deficit of $713.6 million and $567.5 million, respectively. In September 2020, the Company successfully raised $118.7 million through public offering of its shares, thus alleviated the substantial doubt about the Company’s ability to continue as a going concern as of June 30, 2020. As of December 31, 2020, the Company had cash and cash equivalents of $69.6 million, restricted cash of $16.5 million, and short-term investments of $138.6 million. The Company believes that the existing cash and cash equivalents, restricted cash, and short-term investments will fund operations into the second quarter of 2022. The Company’s estimates are based on relevant conditions that are known and reasonably knowable at the date of these consolidated financial statements being available for issuance, and are subject to change due to changes in business, industry or macroeconomic conditions Further, The Company is subject to a number of risks similar to other biopharmaceutical companies, including, but not limited to, the lack of available capital, possible failure of preclinical testing or clinical trials, inability to obtain marketing approval of product candidates, competitors developing new technological innovations, unsuccessful commercialization strategy and launch plans for its proprietary drug candidates, market acceptance of the Company’s products, and protection of proprietary technology. If the Company or its partners do not successfully commercialize any of the Company’s product candidates, it will be unable to generate sufficient product revenue and might not, if ever, achieve profitability and positive cash flow. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements reflect the accounts and operations of the Company and those of its subsidiaries in which the Company has a controlling financial interest. Intercompany transactions and balances have been eliminated. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amount of revenue and expenses during the reporting period. Such management estimates include those relating to assumptions used in clinical research accruals, chargebacks, measurement of acquired assets and assumed liabilities in business combinations, provision for credit losses, inventory reserves, deferred income taxes, the estimated useful life and recoverability of long-lived assets, and the valuation of stock-based awards and other items as appropriate. Actual results could differ from those estimates. Functional Currency Assets and liabilities of subsidiaries that prepare financial statements in currencies other than the U.S. dollar are translated using rates of exchange as of the balance sheet date and the statements of operations and comprehensive loss are translated at the average rates of exchange for each reporting period. The Company recorded a foreign currency translation loss in accumulated other comprehensive loss of $0.5 million for the year ended December 31, 2020, a gain of $0.1 million for the year ended December 31, 2019 and a loss of $0.5 million for the year ended December 31, 2018. Cash, Cash Equivalents, Restricted Cash, and Short-term Investments The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. The Company deposits its cash primarily in checking, money market accounts, as well as short-term investments including certificates of deposit. Funds held in foreign accounts that are subject to regulations governing transfers oversees are included within cash and cash equivalents. As of December 31, 2020 and 2019, the Company had $42.5 million and $7.6 million, respectively, at its Chinese subsidiaries, which were subject to Chinese funds transfer limitations, but available for the Company’s general use. Restricted cash consists of deposits that are restricted as to their withdrawal or use. Restricted cash primarily include amounts held in a controlled bank account in connection with the Senior Credit Agreement. The Company generally does not enter into investments for trading or speculative purposes, rather to preserve its capital for the purpose of funding operations. Accounts Receivable, net Accounts receivable are recorded at the invoiced amount. On a periodic basis, the Company evaluates its accounts receivable and establishes a provision for credit losses, based upon a history of past write-offs, the age of the receivables, and current credit conditions. Credit Losses The Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables and contract assets recorded under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers To determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of customer, as the Company determined that risk profile of its customers is consistent based on the type and industry in which they operate. These customer classes include pharmaceutical wholesalers for specialty product sales, drug manufacturers for active pharmaceutical ingredient (API) sales, and hospitals and end-users for 503B sales. Each class of customer is analyzed for estimated credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available. Further, the Company considers macroeconomic factors and the status of the pharmaceutical industry, including unemployment rates, industry indices, and other factors, to estimate if there are current expected credit losses within its trade receivables based on the trends and the Company’s expectation of the future status of such economic and industry-specific factors. The Company believes that its customers, the majority of which are in the pharmaceutical industries with sound financial condition, and therefore, the Company’s evaluation of macroeconomic and industry-specific factors did not have a significant impact on the provision for credit losses. As of December 31, 2020 and 2019, the Company recorded a provision for credit losses of $0.7 million and $0.1 million, respectively, for accounts receivable related to the customer classes of pharmaceutical wholesalers, drug manufacturers, and hospitals and end users. Expected credit losses related to contract assets are evaluated on an individual basis. The Company’s contract assets relate to upfront fees or milestone payments due from licensees for which the underlying performance obligations have been satisfied. The Company evaluates the financial status of the licensee and any historical payment activity from them. Macroeconomic and industry-specific factors are considered when estimated current expected credit losses related to contract assets. Contract assets are generally classified as short-term, and the Company is in frequent communication with licensees to establish timely payment terms. If the Company expects that credit losses exist for license-related contract assets, it will record provision for such losses against the contract asset. As of December 31, 2019, the Company determined that credit losses related to its contract assets recognized in connection with its license arrangements were not expected to be significant. In the third quarter of 2020, pursuant to the 2019 Xiangxue License, the Company recognized $9.4 million license revenue, net of $0.6 million value added tax, for a milestone achievement. As of February 28, 2021, the Company only received $1.5 million of the $10.0 million milestone achievement. After consideration of historical collection rates, the current financial status of the counterparty, and other macroeconomic factors, the Company recorded a provision for its expected credit losses for the outstanding balance of $8.5 million and $0.4 million related to currency conversion in its consolidated financial statements for the three months and year ended December 31, 2020, respectively. Inventories Prior to the regulatory approval of product candidates, the Company may incur expenses for the manufacture of drug product to support the commercial launch of those products. Until the date at which regulatory approval has been received or is otherwise considered probable, all such costs are recorded as research and development expenses as incurred. Inventories for special products and 503B products are stated at the lower of cost and net realizable value, with approximate cost being determined on a first-in-first-out basis. API inventory is stated at the lower of cost and net realizable value, with approximate cost being determined on a weighted average basis. The Company provides inventory write-downs based on excess and obsolete inventories determined primarily by future demand forecasts. The write-down is measured as the difference between the cost of the inventory and market, based upon assumptions about future demand, and is charged to the provision for inventory, which is a component of cost of sales. At the point of the loss recognition, a new, lower cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the restoration or increase in that newly established cost basis. Reserves for inventory amounted to $6.2 million and $9.0 million as of December 31, 2020 and 2019, respectively. Property and Equipment, net Property and equipment are recorded at cost or acquisition date fair value in a business acquisition. Depreciation is recorded over the estimated useful lives of the related assets using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the useful life or term of the lease. Upon retirement or disposal, the cost and related accumulated depreciation are removed from the consolidated balance sheets and the resulting gain or loss is recorded to general and administrative expense in the consolidated statements of operations and comprehensive loss. Routine expenditures for maintenance and repairs are expensed as incurred. Estimated useful lives for property and equipment are as follows: Property and Equipment Estimated Useful Life Land Not depreciated Equipment 5 - 8 years Furniture and fixtures 5 years Computer hardware 3 years Leasehold improvements Lesser of estimated useful life or remaining lease term Construction in process Not depreciated Leases On January 1, 2019, the Company adopted FASB Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) The lease liabilities are determined as the present value of future fixed minimum lease payments. In determining the discount rate, the Company uses rates implicit in the lease, or if not readily available, the Company uses an estimated incremental borrowing rate based on yield trends in the biotechnology and healthcare industry and debt instruments held by the Company with stated interest rates. The Company uses the stated rate per lease agreement in determining the finance lease liabilities. The lease term is determined at the commencement date and considers whether it is reasonably certain that the Company will exercise renewal options or termination options. The lease liabilities and ROU asset are amortized over the term of the lease with operating lease expenses being recognized on a straight-line basis over the lease terms. Leases with an initial lease term of 12 months or less are not recorded on the consolidated balance sheet. Lease expense for these leases is recognized on a straight-line basis over the lease term. Fair Value of Financial Instruments The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. Financial instruments consist of cash and cash equivalents, restricted cash, short-term investments, accounts receivable, other current assets, accounts payable, accrued expenses, and other. These financial instruments are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. Goodwill The Company tests goodwill for impairment annually on October 1 st Intangible Assets, net Intangible assets arising from a business acquisition are recognized at fair value as of the acquisition date. The Company amortizes intangible assets using the straight-line method. When the straight-line method of amortization is utilized, the estimated useful life of the intangible asset is shortened to assure the recognition of amortization expense corresponds with the expected cash flows. Other purchased intangibles, including certain licenses, are capitalized at cost and amortized on a straight-line basis over the license life, when a future economic benefit is probable and measurable. If a future economic benefit is not probable or measurable, the license costs are expensed as incurred within research and development expenses. Impairment of Long-Lived Assets The Company reviews the recoverability of its long-lived assets, excluding goodwill, when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on the ability to recover the carrying value of the assets from the expected future cash flows (undiscounted and without interest expense) of the related operations. If these cash flows are less than the carrying value of such assets, an impairment loss for the difference between the estimated fair value and carrying value is recorded. No impairment charges were recorded during the year ended December 31, 2020. Impairment charges of $0.2 million and $0.3 million were recorded for the years ended December 31, 2019, and 2018, respectively. See Note 6 – Goodwill and Intangible Assets, net Treasury Stock The Company records treasury stock activities at the cost of the acquired stock. The Company’s accounting policy upon the formal retirement of treasury stock is to deduct the par value from common stock and to reflect any excess of cost over par value as a reduction to additional paid-in capital (to the extent created by previous issuances of the stock) and then accumulated deficit. Revenue Recognition Effective January 1, 2018, the Company adopted ASC, Topic 606, “ Revenue from Contracts with Customers Revenue Recognition Research and Development Expenses Costs for research and development (“R&D”) of products, including payroll, contractor expenses, and supplies, are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development arrangements, the obligations are recorded when the milestone results are probable of being achieved. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Changes in unrealized gains and losses on investments and foreign currency translation adjustments represent the differences between the Company’s net loss and comprehensive loss. Stock-Based Compensation Awards granted to employees The Company recognizes stock-based compensation based on the grant date fair value of stock options granted to employees, officers, and directors. The Company used the Black-Scholes option pricing model to calculate the grant date fair value of stock options. The Black-Scholes option pricing model requires inputs for risk-free interest rate, dividend yield, volatility, fair value of common stock, and expected lives of the stock options. The risk-free rate for periods within the expected life of the stock option is based on the U.S. Treasury yield curve in effect at the time of the grant. No dividend yield is used, consistent with the Company’s history. Expected volatility is based on historical volatilities of the stock prices of peer biopharmaceutical companies. The fair value of common stock is based on the quoted market price of the Company’s common stock on grant date. The Company uses the simplified method for determining the expected lives of stock options. The Company recognizes compensation expenses based on the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting period. Stock grants The Company grants common stock to key officers and directors and records the fair value of these grants, based on the fair value of the common stock on the grant date, as compensation expense throughout the requisite service period. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Deferred income tax assets and liabilities are recognized for the estimated future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred income tax expense or benefit is the result of changes in the deferred income tax assets and liabilities. Valuation allowances are established when necessary to reduce deferred income tax assets where, based upon the available evidence, management concludes that it is more-likely-than not that the deferred income tax assets will not be realized. In evaluating its ability to recover deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, ongoing tax planning and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis. Because of the uncertainty of the realization of the deferred income tax assets, the Company has recorded a valuation allowance against its deferred income tax assets. Reserves are provided for tax benefits for which realization is uncertain. Such benefits are only recognized when the underlying tax position is considered more likely than not to be sustained on examination by a taxing authority, assuming they possess full knowledge of the position and facts. Interest and penalties related to uncertain tax positions are recognized in income tax expense; however, the Company currently has no interest or penalties related to income taxes. Segment and Geographic Information The Company’s chief operating decision-maker, its Chief Executive Officer, reviews its operating results on an aggregate basis and at the operating segment level for purposes of allocating resources and evaluating financial performance. The Company has three business platforms which are the operating segments: (1) Oncology Innovation Platform, for the discovery and development of cancer supportive therapies, (2) Commercial Platform, the manufacturing and selling of commercial pharmaceutical products, and (3) Global Supply Chain Platform, the cGMP manufacturing and marketing of API, and clinical products. Each operating segment has a segment manager who is held accountable for operations and operating results. Accordingly, the Company operates in three reportable segments. Concentration of Credit Risk, Other Risks and Uncertainties Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, and short-term investments. The Company deposits its cash equivalents in interest-bearing money market accounts and certificates of deposit and invests in highly liquid U.S. Treasury notes, commercial paper, and corporate bonds. The Company deposits its cash with multiple financial institutions. Cash balances exceed federally insured limits. The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer and establishing a minimum allowable credit rating. The Company also has significant assets and liabilities held in its overseas manufacturing facility, and research and development facility in China, and therefore is subject to foreign currency fluctuation and regulatory uncertainties. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, “ Measurement of Credit Losses on Financial Instruments” |
Restricted Cash
Restricted Cash | 12 Months Ended |
Dec. 31, 2020 | |
Restricted Cash [Abstract] | |
Restricted Cash | 3. The Company has a restricted cash balance of $16.5 million as of December 31, 2020 held in a controlled bank account in connection with the Senior Credit Agreement, which requires the Company to maintain, in a debt service reserve account, a minimum cash balance equal to twelve months of interest on the outstanding loans under the Senior Credit Agreement. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | 4. Inventories consist of the following (in thousands): December 31, 2020 2019 Raw materials and purchased parts $ 6,498 $ 4,176 Work in progress 776 1,870 Finished goods 21,572 26,584 Total inventories $ 28,846 $ 32,630 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 5 . Property and equipment, net, consists of the following (in thousands): December 31, 2020 2019 Land $ 1,190 $ 1,117 Equipment 11,353 6,724 Furniture and fixtures 933 578 Computer hardware 4,183 3,142 Leasehold improvements 2,933 2,792 Construction in process 22,514 14,758 Property and equipment, gross 43,106 29,111 Less: accumulated depreciation (8,718 ) (5,958 ) Property and equipment, net $ 34,388 $ 23,153 Depreciation expense amounted to $2.6 million, $2.0 million, and $1.7 million for the years ended December 31, 2020, 2019, and 2018, respectively. |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets, Net | 6 . Goodwill The changes in the carrying amount of goodwill for each reporting unit to which goodwill is assigned for the periods indicated are as follows (in thousands): Global Supply Chain Oncology Innovation Platform Total Balance as of January 1, 2019 $ 26,233 $ 11,262 $ 37,495 Goodwill acquired — 1,018 1,018 Effect of currency translation adjustment (64 ) 64 — Balance as of December 31, 2019 26,169 12,344 38,513 Effect of currency translation adjustment 327 51 378 Balance as of December 31, 2020 $ 26,496 $ 12,395 $ 38,891 Intangible Assets, Net The Company’s identifiable intangible assets, net, consist of the following (in thousands): December 31, 2020 Cost/Fair Value Accumulated Amortization Impairments Net Amortizable intangible assets Licenses $ 12,641 $ 5,157 $ — $ 7,484 Polymed customer list 1,593 1,418 — 175 Polymed technology 3,712 1,685 — 2,027 Indefinite-lived intangible assets: CDE in-process research and development (IPR&D) 728 — — 728 Effect of currency translation adjustment (196 ) — — (196 ) Total intangibles, net $ 18,478 $ 8,260 $ — $ 10,218 December 31, 2019 Cost/Fair Value Accumulated Amortization Impairments Net Amortizable intangible assets Licenses $ 8,935 $ 3,561 $ — $ 5,374 Polymed customer list 1,593 1,164 — 429 Polymed technology 3,712 1,297 — 2,415 Product rights 530 360 170 — Indefinite-lived intangible assets: CDE in-process research and development (IPR&D) 728 — — 728 Effect of currency translation adjustment (424 ) — — (424 ) Total intangibles, net $ 15,074 $ 6,382 $ 170 $ 8,522 As of December 31, 2020, licenses at cost include an Orascovery license of $0.4 million and licenses purchased from Gland Pharma Ltd (“Gland”) of $4.4 million, a license purchased from MAIA Pharmaceuticals, Inc. (“MAIA”) for $4.0 million, a license purchased from Ingenus Pharmaceuticals, LLC (“Ingenus”) for $2.0 million, and licenses of other specialty products of $0.7 million. The Orascovery license with Hanmi Pharmaceuticals Co. Ltd. (“Hanmi”) was purchased directly from Hanmi and is being amortized on a straight-line basis over a period of 12.75 years, the remaining life of the license agreement at the time of purchase. The licenses purchased from Gland are being amortized on a straight-line basis over a period of 5 years, the remaining life of the license agreement at the time of purchase. The license purchased from MAIA is being amortized over a period of 7 years, the remaining life of the license agreement at the time of purchase. The license purchased from Ingenus is being amortized over a period of 5 years, the estimated useful life of the license agreement. The remaining intangible assets were acquired in connection with the acquisitions of Polymed Therapeutics, Inc. (“Polymed”), Comprehensive Drug Enterprises (“CDE”). Intangible assets are amortized using the straight-line method over their useful lives. The Polymed customer list and technology are amortized on a straight-line basis over 6 and 12 years, respectively. The CDE in-process research and development (“IPR&D”), will not be amortized until the related projects are completed. IPR&D is tested annually for impairment, unless conditions exist causing an earlier impairment test (e.g., abandonment of project). The Company recorded no impairments of IPR&D during the year ended December 31, 2020. During each of the years ended December 31, 2019 and 2018, the Company abandoned projects within IPR&D and therefore, the related balances of $0.2 million and $0.3 million, respectively, were written-off as impaired and were included within research and development expenses in the consolidated statement of operations and comprehensive loss. The weighted-average useful life for all intangible assets was 7.1 years as of December 31, 2020. The Company recorded $1.8 million, $1.9 million, and $1.6 million of amortization expense for the years ended December 31, 2020, 2019, and 2018, respectively. The Company expects amortization expense related to its finite-lived intangible assets for the next 5 years and thereafter to be as follows as of December 31, 2020 (in thousands): Year ending December 31: Estimated Amortization Expense 2021 $ 2,653 2022 1,834 2023 1,805 2024 1,430 2025 1,388 Thereafter 576 $ 9,686 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7 . Financial instruments consist of cash and cash equivalents, restricted cash, short-term investments, an equity investment, accounts receivable, accounts payable, accrued expenses, and debt. Short-term investments and the equity investment are stated at fair value. Cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued expenses, and debt, are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. ASC 820, Fair Value Measurements Level 1 —Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the plan has the ability to access. Level 2 —Inputs to the valuation methodology include: • Quoted prices for similar assets or liabilities in active markets; • Quoted prices for identical or similar assets or liabilities in inactive markets; • Inputs other than quoted prices that are observable for the asset or liability; • Inputs that are derived principally from or corroborated by observable market data by correlation or other means; and • If the asset or liability has a specified (contractual) term, the level 2 input must be observable for substantially the full term of the asset or liability. Level 3 —Inputs to the valuation methodology are unobservable, supported by little or no market activity, and that are significant to the fair value measurement. Transfers between levels, if any, are recorded as of the beginning of the reporting period in which the transfer occurs; there were no The following tables represent the fair value hierarchy for those assets and liabilities that the Company measures at fair value on a recurring basis (in thousands): Fair Value Measurements at December 31, 2020 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Financial assets included within cash and cash equivalents Money market funds $ 5,615 $ 5,615 $ — $ — Short-term investments - certificates of deposit 4,070 — 4,070 — Short-term investments - U.S. government bonds 5,000 — 5,000 — Short-term investments - commercial paper 34,860 — 34,860 — Financial assets included within short-term investments Short-term investments - certificates of deposit 20,696 — 20,696 — Short-term investments - U.S. government bonds 14,998 — 14,998 — Short-term investments - commercial paper 102,715 — 102,715 — Available-for-sale investment 227 227 — — Total assets $ 188,181 $ 5,842 $ 182,339 $ — Fair Value Measurements at December 31, 2019 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Financial assets included within cash and cash equivalents Money market funds $ 5,460 $ 5,460 $ — $ — Short-term investments - certificates of deposit 15,110 — 15,110 — Short-term investments - commercial paper 51,017 — 51,017 — Financial assets included within short-term investments Short-term investments - certificates of deposit 10,054 — 10,054 — Short-term investments - commercial paper 22,835 — 22,835 — Available-for-sale investment 250 250 — — Total assets $ 104,726 $ 5,710 $ 99,016 $ — The Company classifies its money market funds within Level 1 because it uses quoted market prices to determine their fair value. The Company classifies its commercial paper, corporate notes, certificates of deposit, and U.S. government bonds within Level 2 because it uses quoted prices for similar assets or liabilities in active markets and each has a specified term and all level 2 inputs are observable for substantially the full term of each instrument. The Company owns 68,000 shares of PharmaEssentia Corp. (“PharmaEssentia”), a company publicly traded on the Taiwan OTC Exchange. As of December 31, 2020 and 2019, the Company’s investment in PharmaEssentia is valued at the reported closing price. This investment is classified as a level 1 investment and is recorded as an available-for-sale investment within short-term investments on the Company’s consolidated balance sheet. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
ACQUISITIONS | 8 . AXIS On June 29, 2018, the Company entered into a Share Subscription Agreement (“SSA”) for Axis Therapeutics Limited (“Axis”), a subsidiary of the Company jointly owned by Athenex and Xiangxue Life Sciences Limited (“XLifeSc”). Under the SSA, Athenex contributed $30.0 million cash for a 55% ownership interest in Axis and XLifeSc contributed a license for IPR&D of certain immunotherapy technology for a 45% ownership interest in Axis. Also, on June 29, 2018, through a license agreement entered into between XLifeSc and Axis, XLifeSc granted Axis an exclusive, sublicensable worldwide (excluding mainland China) right and license to use its proprietary TCR-T therapy to develop and commercialize products for oncology indications (“TCR-T License”). Upon effectiveness of the TCR-T License and satisfaction of certain conditions of the license agreement, the Company issued 267,952 shares of its common stock equal to $5.0 million to XLifeSc. The Company has consolidated the financial statements of Axis into its consolidated financial statements as of and for the years ended December 31, 2020, 2019, and 2018 using the voting interest model. The nonmonetary exchange of 45% of the shares of Axis for the IPR&D from XLifeSc has been accounted for as an asset acquisition that does not constitute a business under ASC 805. Therefore, the acquisition of IPR&D was expensed as research and development expense at its fair value. The Company determined that the fair value of the equity issued to XLifeSc was $24.5 million for the IPR&D, considering the $30.0 million contribution made by the Company for its 55% ownership interest and the arms-length nature of the transaction. Accordingly, the Company recorded an expense of $24.5 million within research and development expenses on its consolidated statements of operations and comprehensive loss for the year ended December 31, 2018. On September 27, 2019, the Company executed a sponsorship agreement whereby Athenex will sponsor and conduct all Investigation New Drug applications with the U.S. FDA arising from the TCR-T platform. Axis will pay a fee to the Company for these services and will reimburse Athenex for all costs incurred in connection with the work performed. For the years ended December 31, 2020 and 2019, the Company charged Axis $4.0 million and $1.2 million for these expenses, respectively. This amount is included within research and development expenses. The minority interests’ portion of these expenses is recorded within net loss attributable to non-controlling interests on the Company’s consolidated statements of operations and comprehensive loss. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 9 . Accrued expenses consist of the following (in thousands): December 31, 2020 2019 Accrued selling fees, rebates, and royalties $ 9,046 $ 1,577 Accrued wages and benefits 6,720 7,541 Accrued construction costs 4,104 22,811 Accrued inventory purchases 3,714 7,194 Accrued interest 3,583 — Accrued operating expenses 3,222 1,885 Accrued clinical expenses 2,949 2,510 Accrued tax withholdings 1,948 187 Accrued costs for product launch 1,474 — Deferred revenue 1,147 218 Accrued R&D licensing fees 366 384 Total accrued expenses $ 38,273 $ 44,307 The accrued construction costs relate to the building of the manufacturing facility in Dunkirk, NY (see Note 13 – Business and Economic Collaborative Agreements December 31, 2020. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10 . The Company recorded income tax expense of $4.1 million, $0.9 million, and $0.1 million during the years ended December 31, 2020, 2019, and 2018, respectively. The current and prior year income tax expense is attributable to foreign withholding taxes. The Company and its other subsidiaries were in a cumulative loss position as of December 31, 2020. The components of loss before income tax expense consist of the following (in thousands): Year Ended December 31, 2020 2019 2018 Domestic $ (133,929 ) $ (109,769 ) $ (95,479 ) Foreign (10,417 ) (14,836 ) (33,132 ) $ (144,346 ) $ (124,605 ) $ (128,611 ) The components of the income tax expense consist of the following (in thousands): Year Ended December 31, 2020 2019 2018 Current: Federal $ — $ — $ — State 4 23 27 Foreign 4,026 419 455 4,030 442 482 Deferred: Federal (27,279 ) (26,878 ) (26,260 ) State (916 ) (2,567 ) (293 ) Foreign (1,424 ) (2,411 ) (1,863 ) (29,619 ) (31,856 ) (28,416 ) Change in valuation allowance 29,677 32,342 28,034 $ 4,088 $ 928 $ 100 The income tax expense differs from the federal statutory rate due to the following: Year Ended December 31, 2020 2019 2018 Statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 0.7 2.0 0.2 Foreign rate differential 0.1 0.1 (0.3 ) Valuation allowance (20.3 ) (25.9 ) (21.6 ) Stock-based compensation (2.6 ) — — Foreign tax withholdings (2.3 ) (0.2 ) — Other 0.6 1.9 0.6 (2.8 )% (0.7 )% (0.1 )% Net deferred income tax liabilities consist of the following (in thousands): December 31, 2020 2019 Intangible assets $ 11,372 $ 11,348 Property and equipment 51 77 Stock-based compensation 7,148 9,551 Net operating loss carryforwards 106,342 81,630 Tax credit carryforwards 13,528 9,191 Research and development deduction 1,859 1,493 Reserves and accruals 11,472 8,377 Gross deferred income tax assets 151,772 121,667 Less: valuation allowance (150,864 ) (120,805 ) Net deferred income tax assets 908 862 Intangible assets (821 ) (862 ) Property and equipment (143 ) — Gross deferred income tax liabilities (964 ) (862 ) Net deferred income tax liabilities $ (56 ) $ — As of December 31, 2020, there exists $448.5 million federal net operating losses and $88.2 million of state net operating losses, respectively. Of the federal net operating losses, $184.8 million expire beginning in 2027 and $263.7 million have an indefinite life. In addition, there exists $34.2 million of foreign net operating losses as of December 31, 2020 which may be carried forward indefinitely. The valuation allowance for deferred tax assets increased by $29.7 million for the year ended December 31, 2020 and increased by $32.3 million for the year ended December 31, 2019. The change in the valuation allowance was due to an increase of deferred tax assets mainly for additional net operating losses and tax credit carryforwards. The Company has provided a full valuation allowance against its deferred tax assets as it has determined that it is not more likely than not that recognition of such deferred tax assets will be utilized in the foreseeable future. The Company considers whether any positions taken on the Company’s income tax returns would be considered uncertain tax positions that may require the recognition of a liability. The Company has concluded that there are no material uncertain tax positions as of December 31, 2020, 2019, and 2018. The Company recognizes interest and penalties related to unrecognized tax benefits as a component of income tax benefit in the consolidated statement of operations and comprehensive loss. There were no amounts recognized for interest and penalties related to unrecognized tax benefits during the years ended December 31, 2020, 2019, and 2018. The income tax returns for the taxable years 2014 to 2019 in the U.S., China, and Hong Kong remain open and subject to income tax audits. Provision has not been made for U.S. taxes on undistributed earnings of foreign subsidiaries. Those earnings, if any, have been and will continue to be indefinitely reinvested. Under the provisions of Section 382 of the Internal Revenue Code (“IRC”), net operating loss and credit carryforwards and other tax attributes may be subject to limitation if there has been a significant change in ownership of the Company, as defined by the IRC. Changes in ownership of our common stock could result in limitations on net operating loss carryforwards. On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) into law. The CARES Act includes several significant business tax provisions that, among other things, would eliminate the taxable income limit for certain net operating losses (“NOLs”) and allow businesses to carry back NOLs arising in 2018, 2019, and 2020 to the five prior tax years, accelerate refunds of previously generated corporate alternative minimum tax credits, change the business interest limitation under Internal Revenue Code (“IRC”) section 163(j) of the IRC from 30 percent to 50 percent, and fix qualified improvement property from the Tax Cuts and Jobs Act of 2017 |
Debt and Lease Obligations
Debt and Lease Obligations | 12 Months Ended |
Dec. 31, 2020 | |
Debt And Lease Obligations [Abstract] | |
Debt and Lease Obligations | 1 1 . Debt The Company’s debt as of December 31, 2020 and 2019, consists of the following (in thousands): December 31, 2020 2019 Current portion of mortgage $ 731 $ 686 Current portion of bank loan 764 — Current portion of senior secured loan 70 — Current portion of finance lease obligations 445 194 Current portion of operating lease obligations 3,185 3,010 Long-term portion of finance lease obligations 537 227 Long-term portion of operating lease obligations 6,355 7,620 Chongqing Maliu credit agreement 7,641 5,731 Senior secured loan, net of debt discount and financing fees of $11,601 and $3,592, respectively 138,399 46,408 Total $ 158,127 $ 63,876 Senior Credit Agreements During 2018, Perceptive issued a senior secured loan to the Company with a principal value of $50.0 million and a maturity date of June 30, 2023. The loan bore interest at a floating per annum rate equal to LIBOR (with a floor of 2.0%) plus 9.0%. The Company was required to make monthly interest-only payments with a bullet payment of the principal at maturity. On June 19, 2020, the Company paid off all obligations owing under, and terminated, the senior secured loan agreement with Perceptive. The secured interests were terminated in connection with the Company’s payoff of all obligations. In connection with the repayment of the Perceptive loan, the Company incurred a $3.8 million prepayment fee, the unamortized debt discount of $3.1 million, and $0.3 million in other charges. The Perceptive debt extinguishment resulted in a $7.2 million loss that was included in loss on extinguishment of debt, in the consolidated statements of operations and comprehensive loss. On June 19, 2020 (“Closing Date”), the Company entered into the Senior Credit Agreement with Oaktree to borrow up to $225.0 million in five tranches, with a maturity date of June 19, 2026. The first three tranches (“Tranche A”, “Tranche B”, and “Tranche C”) of the term loans with an aggregate principal amount of $150.0 million were drawn by the Company in 2020. A portion of the proceeds of the first tranche was used to repay in full the senior secured loan with Perceptive, including related prepayment fees, unpaid interest, and legal fees. The fourth tranche of $25.0 million (“Tranche D”) will be available to the Company from 90 days after the Closing Date through June 20, 2022, subject to the Company’s satisfaction of certain regulatory and commercial milestones; and the fifth tranche of $50.0 million (“Tranche E”) will be available to the Company from 90 days after the Closing Date through June 19, 2023, also subject to the Company’s satisfaction of certain regulatory and commercial milestones. The loan bears interest at a fixed annual rate of 11.0%. The Company is required to make quarterly interest-only payments until June 19, 2022, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. Beginning on September 17, 2020, the Company was required to pay a commitment fee on any undrawn commitments equal to 0.6% per annum, payable on each subsequent funding date or the commitment termination date. Prepayments of the loan, in whole or in part, will be subject to early prepayment fee which declines each year until the fourth anniversary date of the Closing Date, after which no prepayment fee is required. Upon the final payment, the Company must also pay an exit fee calculated based on a percentage of the aggregate principal amount of all tranches advanced to the Company, and as of December 31, 2020, the Company has reflected a long-term exit fee liability of $2.0 million within long-term debt and finance lease obligations on the consolidated balance sheet. The Senior Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that were customarily required for similar financings. The Company is subject to certain financial covenants under the Senior Credit Agreement, including (1) a minimum liquidity amount in cash or permitted cash equivalent investments of $20.0 million from the closing date until the date on which the aggregate principal amount of loans outstanding is greater than or equal to $150.0 million (the “First Step-Up Date”), $25.0 million from the First Step-Up Date until the date on which the aggregate principal amount of loans outstanding balance is equal to $225.0 million (the “Second Step-Up Date”), and $30.0 million from the Second Step-up Date until the maturity date; (2) minimum revenue no less than 50% of target revenue beginning with the fiscal quarter ended on December 31, 2020 and with respect to each such subsequent fiscal quarter prior to the revenue covenant termination date; (3) leverage ratio covenant not to exceed 4.50 to 1.00 as of the last day of any fiscal quarter beginning with the first fiscal quarter following the revenue covenant termination date. At December 31, 2020, the Company was in compliance with all applicable debt covenants. Revenue Interest Financing Agreement On August 4, 2020, the Company entered into a Revenue Interest Financing Agreement with Sagard, pursuant to which Sagard agreed to pay the Company $50.0 million to provide funding for the Company’s development and commercialization of Oral Paclitaxel upon receipt of marketing authorization for Oral Paclitaxel by the U.S. FDA for the treatment of metastatic breast cancer. In exchange for the Product Payment, the Company agreed to make payments to Sagard equal to 5.0% of its world-wide net sales of Oral Paclitaxel, subject to a hard cap equal to the lesser of 170% of the Product Payment and the Put/Call Price as discussed below and further set forth in the Revenue Interest Financing Agreement. The Company is required to make certain additional payments to Sagard to the extent Sagard has not received Payments equaling at least $20.0 million by September 30, 2024 and at least $50.0 million by August 4, 2026, in the amount of the applicable shortfall, and, subject to the Hard Cap, if Sagard has not received Payments equaling at least $85.0 million by the tenth anniversary of the date the Product Payment is funded, in an amount such that Sagard will have obtained a 6.0% internal rate of return on the Product Payment. The Company’s obligations under the Revenue Interest Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Oaktree as administrative agent for the lenders under our Senior Credit Agreement, by a perfected security interest in (i) accounts receivable arising from net sales of Oral Paclitaxel and (ii) intellectual property that is claiming or covering Oral Paclitaxel itself or any method of using, making or manufacturing Oral Paclitaxel. At any time after August 4, 2022, the Company will have the right, but not the obligation (the “Call Option”), to buy out Sagard’s interest in the Payments at a repurchase price (the “Put/Call Price”) equal to (a) on or before August 4, 2023, a payment sufficient to generate an internal rate of return of 18.0% of the Product Payment, (b) after August 4, 2023 and on or before August 4, 2024, a payment sufficient to generate an internal rate of return of 16.0% of the Product Payment, (c) after August 4, 2024 and on or before August 4, 2025, a payment sufficient to generate an internal rate of return of 15.0% of the Product Payment, and (d) thereafter, the greater of (i) an amount that, when paid to Sagard, would generate an internal rate of return of 13.0% of the Product Payment, and (ii) an amount equal to the product of the Product Payment and 165%, in the case of each foregoing clause (a) through (d), taking into account all other payments received by Sagard from us under the Revenue Interest Financing Agreement. The Revenue Interest Financing Agreement contains customary representations and warranties and certain restrictions on our ability to incur indebtedness and grant liens on intellectual property related to Oral Paclitaxel. In addition, the Revenue Interest Financing Agreement provides that if certain events (“Put Option Events”) occur, including certain bankruptcy events, non-payment of Payments, a change of control, an out-license or sale of all of the rights in and to Oral Paclitaxel in the U.S. (other than any out-licensing transaction that includes all or substantially all of the U.S. and European development and commercialization rights to Oral Paclitaxel with a pharmaceutical company with global annual revenues for its most recently completed fiscal year that is greater than or equal to $500.0 million attributable to its oncology business) and (subject to applicable cure periods) non-compliance with the covenants in the Revenue Interest Financing Agreement, Sagard may require us to repurchase its interests in the Payments at the Put/Call Price. Sagard may also terminate the Revenue Interest Financing Agreement if the Company has not received marketing authorization for Oral Paclitaxel by the FDA for the treatment of metastatic breast cancer by December 31, 2021. The Company has evaluated the terms of the Revenue Interest Financing Agreement and concluded that the features of the Product Payment are similar to those of a debt instrument. Accordingly, the Company will account for the transaction as long-term debt. In connection with the debt, the Company granted warrants to Sagard and the IMCO Investors to purchase up to 201,865 shares of its common stock at a purchase price of $12.63 per share. As a result of the issuance of the additional warrants, the Company evaluated the debt modification in accordance with ASC 470 and concluded that the assigned debt qualified for a partial debt extinguishment of the existing Senior Credit Agreement with Oaktree. Therefore, the Company recorded a loss on partial extinguishment of debt in the amount of $3.0 million for the year ended December 31, 2020. The Company will subsequently measure the transaction pursuant to ASC 835 using the effective interest rate method. The Company has elected to apply the prospective method to address changes in the estimated cash flows. Credit Agreements, Bank Loan and Mortgage During the first quarter of 2019, the Company was issued an unsecured, subordinated bank loan from China Merchants Bank to fund operations in China. This loan had a principal value of $0.7 million, a maturity date of December 11, 2019, and bore interest at a fixed rate of 5.7% annually. The loan was paid in full as of December 31, 2019. During the second quarter of 2019, the Company entered into a credit agreement which amended the existing partnership agreement with Chongqing Maliu Riverside Development and Investment Co., LTD (“CQ”), for a Renminbi ¥50.0 million (USD $7.7 million at December 31, 2020) line of credit to be used for the construction of the new API plant in China. The Company is required to repay the principal amount with accrued interest within three years after the plant receives the cGMP certification, with 20% of the total loan with accrued interest is due within the first twelve months following receiving the certification, 30% of the total loan with accrued interest due within twenty-four months, and the remaining balance with accrued interest due within thirty-six months. Interest accrues at the three-year loan interest rate by the People’s Bank of China for the same period on the date of the deposit of the full loan amount, which is expected to approximate 4.75% annually. If the Company fails to obtain the cGMP certification within three years upon the acceptance of the plant, it shall return all renovation costs with the accrued interest to CQ in a single transaction within the first ten business days. As of December 31, 2020, the balance due to CQ was $7.6 million. On May 15, 2020, the Company entered into a credit agreement with China Merchants Bank, enabling the Company to draw up to a Renminbi ¥5.0 million (USD $0.8 million at December 31, 2020) during the period through May 14, 2021. The Company drew the entire available credit in July 2020. This loan has a maturity date of May 14, 2021 and bears interest at a fixed rate of 4.35% annually. The Company is required to make interest and principal payment at maturity. The mortgage payments, assumed in connection with the acquisition of CDE, extend through December 31, 2021. Lease Obligations As described in Note 2 - Summary of Significant Accounting Policies Leases (Topic 842) The Company has operating leases for office and manufacturing facilities in several locations in the U.S., Asia, and Latin America, and has three finance leases for manufacturing equipment used in its facilities near Buffalo, NY (see Note 20 – Commitments and Contingencies) Year Ended December 31, 2020 Year Ended December 31, 2019 Operating lease cost $ 3,041 $ 3,162 Finance lease cost: Amortization of assets 238 81 Interest on lease liabilities 73 31 Total net lease cost $ 3,352 $ 3,274 The Company has elected to exclude short-term leases from its operating lease ROU assets and lease liabilities. Lease costs for short-term leases were not material to the financial statements for the years ended December 31, 2020 and 2019. Variable lease costs for the years ended December 31, 2020 and 2019 were not material to the financial statements. Supplemental balance sheet information related to leases is as follows (in thousands, except lease term and discount rate): December 31, 2020 December 31, 2019 Finance leases: Property and equipment, at cost $ 1,535 $ 688 Accumulated amortization, net (347 ) (109 ) Property and equipment, net $ 1,188 $ 579 Current obligations of finance leases $ 445 $ 194 Long-term portion of finance leases 537 227 Total finance lease obligations $ 982 $ 421 Weighted average remaining lease term (in years): Operating leases 4.23 5.21 Finance leases 3.40 2.11 Weighted average discount rate: Operating leases 12.8 % 12.9 % Finance leases 10.4 % 5.9 % Supplemental cash flow information related to leases is as follows (in thousands): Year Ended December 31, 2020 Cash paid for amount included in the measurements of lease liabilities: Operating cash flows from operating leases $ (3,304 ) Operating cash flows from finance leases (286 ) Financing cash flows from finance leases (73 ) ROU assets recognized in exchange for new operating lease obligations $ 852 Future minimum payments and maturities of leases is as follows (in thousands): Year ending December 31: Operating Leases Finance Leases 2021 $ 3,454 $ 468 2022 2,927 275 2023 2,096 248 2024 2,002 177 2025 1,472 — Thereafter 478 — Total lease payments 12,429 1,168 Less: Imputed interest (2,889 ) (186 ) Total lease obligations 9,540 982 Less: Current obligations (3,185 ) (445 ) Long-term lease obligations $ 6,355 $ 537 Pursuant to the public-private partnership agreements with the State of New York and CQ, the Company will rent the manufacturing facilities from the government with favorable terms. Both facilities are in the final stage of completion as of December 31, 2020. However, neither lease term had commenced as of December 31, 2020, as neither of the facilities were operational and the Company could not direct the use of the facilities. No lease costs were incurred related to the manufacturing facilities during the year ended December 31, 2020. (See Note 13 – Business and Economic Collaborative Agreements – Commitments and Contingencies) The Company exercises judgment in determining the discount rate used to measure the lease liabilities. When rates are not implicit within an operating lease, the Company uses its incremental borrowing rate as its discount rate, which is based on yield trends in the biotechnology and healthcare industry and debt instruments held by the Company with stated interest rates. The Company re-assesses its incremental borrowing rate when new leases arise, or existing leases are modified. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 1 2 . During the years ended December 31, 2020, 2019, and 2018, the Company entered into transactions with individuals and other companies that have financial interests in the Company. Related party transactions included the following: a. In June 2018, the Company entered into two in-licensing agreements with Avalon BioMedical (Management) Limited (“Avalon”) wherein the Company obtained certain IP from Avalon to develop and commercialize the underlying products. Under these agreements the Company is required to pay upfront fees and future milestone payments and sales-based royalties. During the year ended December 31, 2020 and 2019, the Company recorded $0 and $1.0 million milestone fee paid to Avalon, respectively, as research and development expenses on its condensed consolidated statement of operations and comprehensive loss. 1% . In June 2019, the Company entered into an agreement whereby Avalon would hold a 90% ownership interest and the Company would hold a 10% ownership interest of the newly formed entity under the name Nuwagen Limited (“Nuwagen”), incorporated under the laws of Hong Kong. Nuwagen is principally engaged in the development and commercialization of herbal medicine products for metabolic, endocrine, and other related indications. The Company contributed nonmonetary assets in exchange for the 10% ownership interest. b. The Company earns licensing revenue from PharmaEssentia, an entity in which the Company has an investment classified as available-for-sale (see Note 7 – Fair Value Measurements ). F unds paid to PharmaEssentia under the license and cost-sharing agreements amounted to $ 0.4 million in each of the years ended December 31, 2020 and 2019 . Pursuant to out-license agreements, the Company received $ 2.0 million, $ 0 , and $ 2.3 million for the year s ended December 31 , 2020, 2019, and 2018 , respectively . c. The Company receives certain clinical development services from ZenRx Limited and its subsidiaries (“ZenRx”), a company for which one of our executive officers serves on the board of directors. In connection with such services, the Company made payments to ZenRx of $0.6 million, $2.7 million, and $0.3 million for the years ended December 31, 2020, 2019, and 2018, respectively. In April 2013, the Company entered into a license agreement with ZenRx pursuant to which the Company granted an exclusive, sublicensable license to use certain of the Company’s IP to develop and commercialize Oral Irinotecan, and Oral Paclitaxel in Australia and New Zealand, and a non-exclusive license to manufacture a certain compound, but only for use in Oral Irinotecan and Oral Paclitaxel. ZenRx is responsible for all development, manufacturing and commercialization, and the related costs and expenses, of any product candidates resulting from the agreement. No revenue was earned from this license agreement in the periods presented in these consolidated financial statements. d . Certain family members of our executive officers work as employees or consultants of the Company. Such services were not significant to the consolidated financial statements. |
Business and Economic Collabora
Business and Economic Collaborative Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business and Economic Collaborative Agreements | 1 3 . New York State On May 1, 2015, the Company executed an agreement for a medical technology research, development, innovation, and commercialization alliance with Fort Schuyler Management Corporation (“FSMC”), a not-for-profit corporation existing under the laws of the State of New York (the “State”). Under the agreement, FSMC agreed to pay up to $25.0 million for the construction of our North American headquarters and formulation lab and equipment in Buffalo, New York. The Company moved into the North American headquarters in October 2015 and is sub-leasing the space from FSMC for a 10-year term, with an option to extend the term for an additional 10 years. The Company, through its partnership with FSMC, Empire State Development (“ESD”), and The State University of New York (“SUNY”) Polytechnic, was to complete the construction of an ISO Class 5 high potency oral and sterile injectable pharmaceutical manufacturing facility in Dunkirk, New York. This manufacturing facility, which was originally planned to be 320,000 square feet, has been expanded to approximately 409,000 square feet to meet the required needs of the Company and within the terms of the September 2017 agreement. On September 4, 2017, the Company entered into a Grant Disbursement Agreement whereby the State agreed to grant up to approximately $208.0 million, which includes approximately $8.0 million in additional funds available from the previous $25.0 million ESD Grant for the Company’s corporate offices, to fund the construction of the new pharmaceutical manufacturing facility. The Company is also responsible for the costs of furnishing the facility. The Company is entitled to lease the facility and all equipment purchased with grant funds at a rate of $1.00 per year for an initial 10-year term, and for the same rate if the Company elects to extend the lease for an additional 10-year term. In exchange, the Company committed to spending $1.52 billion on operational expenses in the facility in its first 10-year term, and an additional $1.50 billion on operational expenses if the Company elects to extend the lease for a second 10-year term. The State will hold ownership of the manufacturing and office facilities. Construction of these facilities is in the final stage of completion. Chongqing Government Department of Economic Development In October 2015, the Company completed and executed an agreement with the Banan District in Chongqing, China (“CQ”) to construct a cGMP API manufacturing plant of approximately 440,000 square feet and a GMP pharmaceutical manufacturing plant of approximately 510,000 square feet on Banan sites identified and selected by the Company’s management. Under the terms of the agreement, Banan will provide the funding for the land and construction of the manufacturing plants according to Athenex specifications and the Company will equip the plant. This agreement allows the Company to expand its existing high potency oncology active pharmaceutical ingredient manufacturing capacity as well as its drug manufacturing capacity in China. The Company does not have significant construction period risks and the Banan District will fund the construction costs and hold ownership of the facilities. Pursuant to the agreement, the Company is committed to a registration capital requirement of no less than $30.0 million, which can be used as working capital in the course of the business. As of December 31, 2020, the Company had contributed a total of $14.1 million registration capital to its subsidiary set up under the agreement. The land and buildings will be owned by CQ, and the Company will lease the facilities, rent-free, for the first 10-year term, with an option to extend the lease for an additional 10-year term, during which, if the Company is profitable, it will pay a monthly rent of 5 RMB per square meter of space occupied. In addition, the Company is responsible for the costs of all equipment and technology for the facilities. On January 5, 2021, Chongqing Sintaho Pharmaceutical Co., Ltd. (“CQ Sintaho”), a wholly owned subsidiary of the Company, entered into a lease agreement with Chongqing International Biological City Development & Investment Co., Ltd (“CQ D&I”), an affiliate of CQ. Pursuant to the lease agreement CQ Sintaho will lease the newly constructed API facility of 34,517 square meters rent-free, for the first 10-year term, with an option to extend the lease for an additional 10-year term, during which, if CQ Sintaho is profitable, it will pay a monthly rent of 5 Chinese Renminbi per square meter of space occupied. In connection with these arrangements with FSMC and the Banan District we have committed to certain operational milestones. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 1 4 . Common Stock Option Plans The Company has four equity compensation plans, adopted in 2017, 2013, 2007 and 2004 (the “Plans”) which, taken together, authorize the grant of up to 16,000,000 shares of common stock to employees, directors, and consultants. On May 23, 2019, the board of directors approved the amendment and restatement of the 2017 Omnibus Incentive Plan (the “2017 Plan”), which increases the number of shares available for issuance under the plan by up to 500,000 shares, subject to the approval of the Company’s stockholders at the Company’s 2020 annual meeting of stockholders. Additionally, on June 14, 2017, the Company adopted its 2017 Employee Stock Purchase Plan (the “ESPP”), which authorizes the issuance of up to 1,000,000 shares of common stock for future issuances to eligible employees. Stock Options The total fair value of stock options vested and recorded as compensation expense during the year ended December 31, 2020 , 2019 , and 2018 was $9.6 million, $7.9 million, and $9.8 million, respectively. As of December 31, 2020 , $18.7 million of unrecognized cost related to non-vested stock options was expected to be recognized over a weighted-average period of approximately 1.90 Years. T he total intrinsic value of options exercised was approximately $1.5 million and $2.7 million for the years ended December 31, 2020 and 2019 , respectively. The following table summarizes the status of the Company’s stock option activity granted under the Plans and 2017 Plan to employees, directors, and consultants (in thousands, except stock option amounts and exercise price): Stock options granted have a contractual term of 10 years and generally vest over a 2-4 year period. A limited number of stock options vest immediately in certain circumstances. Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2019 10,916,936 $ 8.88 6.87 $ 69,785 Granted 1,970,972 11.46 — — Exercised (238,630 ) 7.23 — — Forfeited and expired (152,390 ) 13.31 — — Outstanding at December 31, 2020 12,496,888 $ 9.26 5.42 $ 22,463 Vested and exercisable at December 31, 2020 9,126,142 $ 7.89 4.29 $ 28,936 The Company determines the fair value of stock option awards on the grant date using the Black-Scholes option pricing model, which is impacted by assumptions regarding a number of highly subjective variables. The following table summarizes the weighted-average assumptions used as inputs to the Black-Scholes option pricing model during the periods indicated: Year Ended December 31, 2020 2019 2018 Weighted average grant date fair value $ 6.93 $ 8.06 $ 9.80 Expected dividend yield — % — % — % Expected stock price volatility 67 % 64 % 59 % Risk-free interest rate 0.91 % 2.60 % 2.61 % Expected life of options (in years) 6.2 6.3 6.1 Restricted Stock Awards The Company granted 131,000 restricted stock awards to employees during the year ended December 31, 2019. Stock-based compensation related to the restricted stock awards amounted to $1.0 million for the year ended December 31, 2020. As of December 31, 2020, $0.3 million of unrecognized cost related to non-vested restricted stock awards were expected to be recognized over a weighted-average period of approximately 1.2 years. No such awards were granted during the year ended December 31, 2020. Employee Stock Purchase Plan The ESPP is available to eligible employees (as defined in the plan document). Under the ESPP, shares of the Company’s common stock may be purchased at a discount (15%) of the lesser of the closing price of the Company’s common stock on the first trading or the last trading day of the offering period. The current offering period extends from December 1, 2020 to May 31, 2021. The Company expects to offer six-month offering periods after the current period. The 2017 Plan reserved 1,000,000 shares of common stock for issuance under the ESPP. Stock-based compensation related to the ESPP amounted to $0.3 million for each of the years ended December 31, 2020 and 2019 and $0.2 million for the year ended December 31, 2018. The Company issued 50,827, 60,825, and 41,733 shares of common stock to participants during the years ended December 31, 2020, 2019, and 2018, respectively. Stock-Based Compensation Cost The components of stock-based compensation and the amounts recorded within research and development expenses and selling, general, and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss consisted of the following for the years ended December 31, 2020, 2019, and 2018 (in thousands): Year Ended December 31, 2020 2019 2018 Stock options $ 9,557 $ 7,887 $ 9,786 Restricted stock expense 1,017 566 1,008 Stock awarded to directors and officers — 1,105 — Employee stock purchase plan 276 327 217 Total stock-based compensation expense $ 10,850 $ 9,885 $ 11,011 Cost of sales $ 249 $ 248 $ 228 Research and development expenses 3,647 3,251 2,621 Selling, general, and administrative expenses 6,954 6,386 8,162 Total stock-based compensation expense $ 10,850 $ 9,885 $ 11,011 |
Net Loss per Share Attributable
Net Loss per Share Attributable to Athenex, Inc. Common Stockholders | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Athenex, Inc. Common Stockholders | 1 5 . Basic net loss per share is calculated by dividing net loss attributable to Athenex, Inc. common stockholders by the weighted-average number of common shares issued, outstanding, and vested during the period. Diluted net loss per share is computed by dividing net loss attributable to Athenex, Inc. common stockholders by the weighted-average number of common share and common shares equivalents for the period using the treasury-stock method. For the purposes of this calculation, warrants for common stock and stock options are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The following weighted average outstanding shares of common stock equivalents were excluded from the calculation of diluted net loss per share attributable Athenex, Inc. to common stockholders for the periods presented because including them would have been antidilutive: Year Ended December 31, 2020 2019 2018 Stock options and other common stock equivalents 12,748,882 10,814,635 10,480,084 Unvested restricted common shares 76,750 45,581 113,260 Total potential dilutive common shares 12,825,632 10,860,216 10,593,344 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Loss | 1 6 . The components and changes of accumulated other comprehensive loss, net of related income tax effects, are as follows (in thousands): Balance as of January 1, 2018 $ (146 ) Foreign currency translation adjustment (525 ) Unrealized gain on investment 15 Balance as of December 31, 2018 (656 ) Foreign currency translation adjustment 118 Unrealized loss on investment (97 ) Balance as of December 31, 2019 (635 ) Foreign currency translation adjustment (494 ) Unrealized loss on investment (5 ) Balance as of December 31, 2020 $ (1,134 ) |
Business Segment, Geographic, a
Business Segment, Geographic, and Concentration Risk Information | 12 Months Ended |
Dec. 31, 2020 | |
Segment Reporting [Abstract] | |
Business Segment, Geographic, and Concentration Risk Information | 1 7 . The Company has three operating segments, which are organized based mainly on the nature of the business activities performed and regulatory environments in which they operate. The Company also considers the types of products from which the reportable segments derive their revenue. Each operating segment has a segment manager who is held accountable for operations and has discrete financial information that is regularly reviewed by the Company’s chief operating decision-maker. Consequently, the Company has concluded each operating segment to be a reportable segment. The Company’s operating segments are as follows: Oncology Innovation Platform — This operating segment performs research and development on certain of the Company’s proprietary drugs, from the preclinical development of its chemical compounds, to the execution and analysis of its several clinical trials. It focuses specifically on Orascovery and Src Kinase Inhibition research platforms, and TCR-T immunotherapy and arginine deprivation therapy. This segment operates in the U.S., Taiwan, Hong Kong, mainland China, the United Kingdom, and Latin America. Global Supply Chain Platform — This operating segment includes APS and Polymed and the construction of the manufacturing facilities in Chongqing, China and Dunkirk, NY. APS is a manufacturing company that supplies sterile injectable drugs to hospital pharmacies across the U.S. APS manufactures products under Section 503B of the Compounding Quality Act within the Federal Food, Drug & Cosmetic Act (“FDCA”). Additionally, APS provides products for the development and manufacturing of the Company’s proprietary drug candidates as well as providing the Company with a cGMP analytical services function. Polymed is primarily in the business of marketing and selling API in North America, Europe, and Asia from its locations in Texas and China. Polymed also develops new compounds and processing techniques and is in the final phase of completion of the new API manufacturing facility in Chongqing, China (see Note 13 – ). Commercial Platform — This operating segment includes APD and Athenex Oncology, which focus on the manufacturing, distribution, and sales of specialty pharmaceuticals and the pre-launch commercial activities for the Company’s proprietary drugs, respectively. This segment provides services and products to external customers based mainly in the U.S. The Company’s Oncology Innovation Platform segment operates and holds long-lived assets located in the U.S., Taiwan, Hong Kong, mainland China, the United Kingdom, and Latin America. The Global Supply Chain Platform segment operates and holds long-lived assets located in the U.S. and China. The Commercial Platform segment operates and holds long-lived assets located in the U.S. For geographic segment reporting, product sales have been attributed to countries based on the location of the customer. Segment information is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Total revenue: Oncology Innovation Platform $ 38,851 $ 20,562 $ 32,776 Global Supply Chain Platform 20,491 33,970 31,274 Commercial Platform 89,572 50,427 30,426 Total revenue for reportable segments 148,914 104,959 94,476 Intersegment revenue (4,523 ) (3,730 ) (5,376 ) Total consolidated revenue $ 144,391 $ 101,229 $ 89,100 Intersegment revenue eliminated in the above table reflects sales from the Global Supply Chain Platform to the Oncology Innovation Platform. Year Ended December 31, 2020 2019 2018 Total revenue by product group: Commercial product sales $ 101,590 $ 67,411 $ 35,640 License fees 38,827 20,100 32,000 API sales 3,599 12,733 17,952 Contract manufacturing revenue 85 391 458 Medical device sales — — 2,344 Other revenue 290 594 706 Total consolidated revenue $ 144,391 $ 101,229 $ 89,100 Intersegment revenue is recorded by the selling segment when it is realized or realizable and all revenue recognition criteria are met. Upon consolidation, all intersegment revenue and related cost of sales are eliminated from the selling segment’s ledger. Year Ended December 31, 2020 2019 2018 Net loss attributable to Athenex, Inc.: Oncology Innovation Platform $ (89,189 ) $ (100,919 ) $ (89,912 ) Global Supply Chain Platform (19,400 ) (8,575 ) (16,858 ) Commercial Platform (37,590 ) (14,255 ) (10,670 ) Total consolidated net loss attributable to Athenex, Inc. $ (146,179 ) $ (123,749 ) $ (117,440 ) Year Ended December 31, 2020 2019 2018 Total depreciation and amortization Oncology Innovation Platform $ 776 $ 762 $ 690 Global Supply Chain Platform 2,048 1,489 1,603 Commercial Platform 1,668 1,566 976 Total consolidated depreciation and amortization $ 4,492 $ 3,817 $ 3,269 December 31, 2020 2019 Total assets: Oncology Innovation Platform $ 234,153 $ 194,183 Global Supply Chain Platform 99,087 63,598 Commercial Platform 51,089 52,151 Total assets $ 384,329 $ 309,932 Year Ended December 31, 2020 2019 2018 Total revenue United States $ 82,362 $ 67,794 $ 37,904 China 39,796 2,105 4,416 United Kingdom 19,289 1,023 — South Korea 2,354 513 — Austria 226 4,422 9,569 India — 3,066 3,457 Spain — 20,000 30,000 Other foreign countries 364 2,306 3,754 Total consolidated revenue $ 144,391 $ 101,229 $ 89,100 December 31, 2020 2019 Total property and equipment, net: United States $ 15,511 $ 11,486 China 18,877 11,667 Total property and equipment, net $ 34,388 $ 23,153 Customer revenue and accounts receivable concentration amounted to the following for the identified periods: Year Ended December 31, 2020 2019 2018 Percentage of total revenue by customer: Customer A 26 % — — Customer B 14 % 15 % 9 % Customer C 14 % 16 % 12 % Customer D 13 % — — Customer E 10 % 14 % 9 % Customer F — 20 % 34 % December 31, 2020 2019 Percentage of total accounts receivable by customer: Customer A 33 % 45 % Customer B 23 % 31 % Customer C 16 % 10 % |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue Recognition | 18. The Company records revenue in accordance with ASC, Topic 606, Revenue from Contracts with Customers . Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes 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. Below is a description of principal activities – separated by reportable segments – from which the Company generates its revenue (See Note 17 – Business Segment, Geographic, and Concentration Risk Information ). 1. Oncology Innovation Platform The Company out-licenses certain of its IP to other pharmaceutical companies in specific territories that allow the customer to use, develop, commercialize, or otherwise exploit the licensed IP. In accordance with Topic 606, the Company analyzes the contracts to identify its performance obligations within the contract. Most of the Company’s out-license arrangements contain multiple performance obligations and variable pricing. After the performance obligations are identified, the Company determines the transaction price, which generally includes upfront fees, milestone payments related to the achievement of developmental, regulatory, or commercial goals, and royalty payments on net sales of licensed products. The Company considers whether the transaction price is fixed or variable, and whether such consideration is subject to return. Variable consideration is only included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. If any portion of the transaction price is constrained, it is excluded from the transaction price until the constraint no longer exists. The Company then allocates the transaction price to the performance obligation to which the consideration is related. Where a portion of the transaction price is received and allocated to continuing performance obligations under the terms of the arrangement, it is recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied. The Company’s contracts may contain one or multiple promises, including the license of IP and development services. The licensed IP is capable of being distinct from the other performance obligations identified in the contract and is distinct within the context of the contract, as upon transfer of the IP, the customer is able to use and benefit from it, and the customer could obtain the development services from other parties. The Company also considers the economic and regulatory characteristics of the licensed IP and other promises in the contract to determine if it is a distinct performance obligation. The Company considers if the IP is modified or enhanced by other performance obligations through the life of the agreement and whether the customer is contractually or practically required to use updated IP. The IP licensed by the Company has been determined to be functional IP. The IP is not modified during the license period and therefore, the Company recognizes revenues from any portion of the transaction price allocated to the licensed IP when the license is transferred to the customer and they can benefit from the right to use the IP. The Company recognized $37.7 million in license revenue, net of $2.3 million value added tax (“VAT”), and $1.0 million in license revenue from two of the Company’s out-license arrangements for the year ended December 31, 2020. The Company recognized revenue allocated to the licensed IP performance obligation upon transfer of the license of $0.1 million for the year ended December 31, 2019. Other performance obligations included in most of the Company’s out-licensing agreements include performing development services to reach clinical and regulatory milestone events. The Company satisfies these performance obligations at a point-in-time, because the customer does not simultaneously receive and consume the benefits as the development occurs, the development does not create or enhance an asset controlled by the customer, and the development does not create an asset with no alternative use. The Company considers milestone payments to be variable consideration measured using the most likely amount method, as the entitlement to the consideration is contingent on the occurrence or nonoccurrence of future events. The Company allocates each variable milestone payment to the associated milestone performance obligation, as the variable payment relates directly to the Company’s efforts to satisfy the performance obligation and such allocation depicts the amount of consideration to which the Company expects to be entitled for satisfying the corresponding performance obligation. The Company re-evaluates the probability of achievement of such performance obligations and any related constraint and adjusts its estimate of the transaction price as appropriate. To date, no amounts have been constrained in the initial or subsequent assessments of the transaction price. The Company did not recognize revenue from other performance obligations included in the Company’s out-licensing agreements during the year ended December 31, 2020. The Company recognized revenue allocated to development performance obligations upon transfer to the customer of $20.0 million for the year ended December 31, 2019. Certain out-license agreements include performance obligations to manufacture and provide drug product in the future for commercial sale when the licensed product is approved. For the commercial, sales-based royalties, the consideration is predominantly related to the licensed IP and is contingent on the customer’s subsequent sales to another commercial customer. Consequently, the sales- or usage-based royalty exception would apply. Revenue will be recognized for the commercial, sales-based milestones as the underlying sales occur. The Company exercises significant judgment when identifying distinct performance obligations within its out-license arrangements, determining the transaction price, which often includes both fixed and variable considerations, and allocating the transaction price to the proper performance obligation. The Company did not use any other significant judgments related to out-licensing revenue during the years ended December 31, 2020 and 2019. 2. Global Supply Chain Platform The Company’s Global Supply Chain Platform manufactures API for use internally in its research and development activities as well as its clinical studies, and for sale to pharmaceutical customers globally. The Company generates additional revenue on this platform, by providing small to mid-scale cGMP manufacturing of clinical and commercial products for pharmaceutical and biotech companies and selling pharmaceutical products under 503B regulations set forth by the U.S. FDA. Revenue earned by the Global Supply Platform is recognized when the Company has satisfied its performance obligation, which is the shipment or the delivery of drug products. The underlying contracts for these sales are generally purchase orders and the Company recognizes revenue at a point-in-time. Any remaining performance obligations related to product sales are the result of customer deposits and are reflected in the deferred revenue contract liability balance. 3. Commercial Platform The Company’s Commercial Platform generates revenue by distributing specialty products through independent pharmaceutical wholesalers. The wholesalers then sell to an end-user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price previously established by the end-user and the Company. Upon the sale by the wholesaler to the end-user, the wholesaler will chargeback the difference, if any, between the original list price and price at which the product was sold to the end-user. The Company also offers cash discounts, which approximate 2.3% of the gross sales price, as an incentive for prompt customer payment, and, consistent with industry practice, the Company’s return policy permits customers to return products within a window of time before and after the expiration of product dating. Further, the Company offers contractual allowances, generally in the form of rebates or administrative fees, to certain wholesale customers, group purchasing organizations (“GPOs”), and end-user customers, consistent with pharmaceutical industry practices. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, GPO allowances, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). As of December 31, 2020 and 2019, the Company’s total provision for chargebacks and other deductions included as a reduction of accounts receivable totaled $12.6 million and $14.4 million, respectively. The Company’s total provision for chargebacks and other revenue deductions was $89.3 million, $87.2 million, and $36.5 million for the years ended December 31, 2020, 2019, and 2018, respectively. The Company exercises significant judgment in its estimates of the variable transaction price at the time of the sale and recognizes revenue when the performance obligation is satisfied. Factors that determine the final net transaction price include chargebacks, fees for service, cash discounts, rebates, returns, warranties, and other factors. The Company estimates all of these variables based on historical data obtained from previous sales finalized with the end-user customer on a product-by-product basis. At the time of sale, revenue is recorded net of each of these deductions. Through the normal course of business, the wholesaler will sell the product to the end-user, determining the actual chargeback, return products, and take advantage of cash discounts, charge fees for services, and claim warranties on products. The final transaction price per product is compared to the initial estimated net sale price and reviewed for accuracy. The final prices and other factors are immediately included in the Company’s historical data from which it will estimate the transaction price for future sales. The underlying contracts for these sales are generally purchase orders including a single performance obligation, generally the shipment or delivery of products and the Company recognizes this revenue at a point-in-time. Disaggregation of revenue The following represents the Company’s revenue for its reportable segment by country, based on the locations of the customer (in thousands). For the Year Ended December 31, 2020 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 12,079 $ 70,283 $ 82,362 China 38,760 1,036 — 39,796 United Kingdom — — 19,289 19,289 South Korea — 2,354 — 2,354 Other Foreign Countries 91 499 — 590 Total Revenue $ 38,851 $ 15,968 $ 89,572 $ 144,391 For the Year Ended December 31, 2019 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 17,367 $ 50,427 $ 67,794 Spain 20,000 — — 20,000 Austria — 4,422 — 4,422 India — 3,066 — 3,066 China 562 1,543 — 2,105 United Kingdom — 1,023 — 1,023 Other Foreign Countries — 2,819 — 2,819 Total Revenue $ 20,562 $ 30,240 $ 50,427 $ 101,229 For the Year Ended December 31, 2018 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 7,478 $ 30,426 $ 37,904 Spain 30,000 — — 30,000 Austria — 9,569 — 9,569 China 2,776 1,640 — 4,416 India — 3,457 — 3,457 Other Foreign Countries — 3,754 — 3,754 Total Revenue $ 32,776 $ 25,898 $ 30,426 $ 89,100 The Company also disaggregates its revenue by product group which can be found in Note 17 – Business Segment, Geographic, and Concentration Risk Information. Contract balances The following table provides information about receivables and contract liabilities from contracts with customers. The Company has not recorded any contract assets from contracts with customers (in thousands). December 31, 2020 2019 Accounts receivable, gross $ 45,792 $ 31,207 Chargebacks and other deductions (12,552 ) (14,394 ) Provision for credit losses (9,637 ) (124 ) Accounts receivable, net $ 23,603 $ 16,689 Deferred revenue 1,147 218 Total contract liabilities $ 1,147 $ 218 The following tables illustrate accounts receivable by reportable segments (in thousands). December 31, 2020 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 10,783 $ 4,074 $ 30,935 $ 45,792 Chargebacks and other deductions — (1 ) (12,551 ) (12,552 ) Provision for credit losses (8,919 ) (164 ) (554 ) (9,637 ) Accounts receivable, net $ 1,864 $ 3,909 $ 17,830 $ 23,603 December 31, 2019 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 49 $ 1,522 $ 29,636 $ 31,207 Chargebacks and other deductions — (1 ) (14,393 ) (14,394 ) Provision for credit losses — (114 ) (10 ) (124 ) Accounts receivable, net $ 49 $ 1,407 $ 15,233 $ 16,689 The Company incurs contract obligations on general customer purchase orders that have been accepted but unfulfilled. Due to the short duration of time between order acceptance and delivery of the related product or service, the Company has determined that the balance related to these contract obligations is generally immaterial at any point in time. The Company monitors the value of orders accepted but unfulfilled at the close of each reporting period to determine if disclosure is appropriate. As of December 31, 2020, $1.0 million and $0.1 million of contract liabilities related to customer deposits were made by customers of the Oncology Innovation Platform and the Global Supply Chain Platform, respectively, and as of December 31, 2019, $0.2 million of contract liabilities related to customer deposits were made by customers of the Global Supply Chain Platform. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | 1 9 . The following tables present our unaudited quarterly results of operations for each quarter within the two most recent fiscal years. This unaudited quarterly information has been prepared on the same basis as our audited consolidated financial statements and, in the opinion of management, the statement of operations data includes all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the results of operations for these periods. The results of operations for any quarter are not necessarily indicative of the results of operations for any future periods. Fiscal 2020 Quarter Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 (In thousands, except per share data) Statements of Operations Data: Revenue: Product sales $ 18,547 $ 40,167 $ 24,780 $ 21,780 License and other revenue 28,388 5 10,696 28 Total revenue 46,935 40,172 35,476 21,808 Cost of sales 19,572 33,006 24,510 18,267 Gross profit 27,363 7,166 10,966 3,541 Operating expenses: Research and development expenses 17,192 22,015 18,390 18,307 Selling, general, and administrative expenses 25,748 17,486 22,220 31,401 Total operating expenses 42,940 39,501 40,610 49,708 Operating loss (15,577 ) (32,335 ) (29,644 ) (46,167 ) Net loss (19,718 ) (41,051 ) (37,268 ) (50,397 ) Less: net loss attributable to non-controlling interests (289 ) (600 ) (462 ) (904 ) Net loss attributable to Athenex, Inc. $ (19,429 ) $ (40,451 ) $ (36,806 ) $ (49,493 ) Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted $ (0.24 ) $ (0.50 ) $ (0.44 ) $ (0.53 ) Fiscal 2019 Quarter Ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 (In thousands, except per share data) Statements of Operations Data: Revenue: Product sales $ 25,163 $ 22,033 $ 19,237 $ 14,102 License and other revenue 144 164 127 20,259 Total revenue 25,307 22,197 19,364 34,361 Cost of sales 19,902 16,942 17,071 15,704 Gross profit 5,405 5,255 2,293 18,657 Operating expenses: Research and development expenses 24,475 18,507 19,588 21,823 Selling, general, and administrative expenses 15,188 17,169 16,283 18,109 Total operating expenses 39,663 35,676 35,871 39,932 Operating loss (34,258 ) (30,421 ) (33,578 ) (21,275 ) Net loss (36,230 ) (32,105 ) (34,787 ) (22,411 ) Less: net loss attributable to non-controlling interests (997 ) (74 ) (29 ) (684 ) Net loss attributable to Athenex, Inc. $ (35,233 ) $ (32,031 ) $ (34,758 ) $ (21,727 ) Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted $ (0.53 ) $ (0.44 ) $ (0.45 ) $ (0.28 ) |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 20 . Rental and lease commitments In August 2015, the Company entered into a lease agreement with FSMC to occupy a portion of the Conventus Center for Collaborative Medicine in Buffalo, NY. A deferred rent liability for this agreement of $1.7 million was recorded as of December 31, 2018 and was derecognized upon adoption ASC 842 on January 1, 2019. Total rent expense related to this location, recognized on a straight-line basis, was $1.0 million for the each of the years ended December 31, 2020, 2019, and 2018. In July 2015, CDE entered into an agreement to lease facilities in Hong Kong, which expired in November 2019. Under the rental agreement, CDE made monthly payments of less than $0.1 million for three years beginning on July 1, 2015. Total rent expense related to this location, recognized on a straight-line basis, amounted to $0.3 million, and $0.4 million for the years ended December 31, 2019, and 2018, respectively. In November 2019, CDE entered into an agreement to lease facilities in Hong Kong through November 2022. Rent expense is recognized on a straight-line basis, amounted to $0.1 million for the year ended December 31, 2020. In October 2016, the Company’s Commercial Platform entered into an agreement to lease office space in Chicago, IL. Under the lease agreement, the Company will make monthly payments based on an escalating scale over ten years. Total rent expense related to this location, recognized on a straight-line basis, amounted to $0.3 million for each of the years ended December 31, 2020, 2019, and 2018. A deferred rent liability for this agreement of $0.3 million was recorded as of December 31, 2018 and was derecognized upon adoption ASC 842 on January 1, 2019. In lieu of a security deposit, an irrevocable letter of credit was issued to the landlord in the amount of $0.2 million. The Company leases its manufacturing and office facilities in Chongqing, China, where it produces API and performs research and development. Rent expense is recognized on a straight-line basis and amounted to $0.6 million for each of the years ended December 31, 2020, 2019, and 2018. The Company entered into additional leases for lab space, warehouse facilities, and various equipment in, Houston, TX; Cranford, NJ; Taipei, Taiwan; Latin America; and Buffalo, NY, during 2019 and 2020 which expire at various times through 2026. Rent expense recognized for these operating leases was not material to the financial statements for the years ended December 31, 2020, 2019, and 2018. Future minimum payments under the non-cancelable operating leases consists of the following as of December 31, 2020 (in thousands): Year ending December 31: Minimum payments 2021 $ 3,454 2022 2,927 2023 2,096 2024 2,002 2025 1,472 Thereafter 478 $ 12,429 Commitments under New York State and Chongqing Partnerships Under its partnerships with New York State and CQ as described in Note 13 – Business and Economic Collaborative Arrangements Business and Economic Collaborative Agreements Legal Proceedings From time to time, the Company may become subject to other legal proceedings, claims and litigation arising in the ordinary course of business. In addition, the Company may receive letters alleging infringement of patent or other intellectual property rights. The Company is not currently a party to any other material legal proceedings, nor is it aware of any pending or threatened litigation that, in the Company’s opinion, would have a material adverse effect on the business, operating results, cash flows or financial condition should such litigation be resolved unfavorably. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 2 1 . SUBSEQUENT EVENTS In January 2021, the Company entered into a manufacture and supply agreement with Ingenus for Arsenic Trioxide Injection pursuant to which Ingenus will be the Company’s exclusive supplier of the product and granted the Company a license to market and sell the product to acute care GPOs and their entire memberships as provided by said GPOs, IDNs and to hospitals within the U.S. Under the agreement, the Company is entitled to 45% of the net profits from its sales of the product and also entitled to a marketing allowance. The agreement has a 5 year term, which may be extended upon mutual agreement (See Commercialization - Our Commercial Platform – Specialty Pharmaceuticals – Ingenus Agreements). On January 5, 2021, CQ Sintaho entered into a lease agreement with CQ D&I. Under the lease agreement, the provisions of which are consistent with those agreed upon in the 2015 Agreement, CQ Sintaho will lease the newly constructed API facility, or Sintaho API Facility, of 34,517 square meters rent-free, for the first 10-year term, with an option to extend the lease for an additional 10-year term, during which, if CQ Sintaho is profitable, it will pay a monthly rent of 5 RMB per square meter of space occupied (See - Business and Economic Collaborative Agreements - Chongqing Government Department of Economic Development On February 15, 2021, the Company entered into a Second Amendment to its 2011 license agreement with PharmaEssentia for tirbanibulin ointment. The Second Amendment expands the territory to include Japan and South Korea and includes a license to use the intellectual property for additional dermatology indications and skin cancer in the existing territories. Pursuant to this Second Amendment, the Company will receive an upfront payment of $0.5 million, milestone payments up to $13.0 million associated with the achievement of certain development and sales milestone, as well as royalties on the sale of tirbanibulin ointment in Japan and South Korea. The Company will supply PharmaEssentia with the licensed products under a supply arrangement for a separate fee. The Company will account for this in accordance with ASC 606 and is evaluating the effect on its consolidated financial statements. On February 26, 2021, the Company received a CRL from the FDA regarding our NDA for Oral Paclitaxel for the treatment of metastatic breast cancer |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2020 | |
Valuation And Qualifying Accounts [Abstract] | |
Schedule of Valuation and Qualifying Accounts | Schedule II—Valuation and Qualifying Accounts Activity in the following valuation and qualifying accounts consisted of the following (in thousands): Col. C - Additions Col. A Description Col. B Balance at Beginning of Period Charged to Costs & Expenses Charged to Other Accounts - Describe Col. D Deductions - Describe Col. E Balance at End of Period December 31, 2020 Provision for credit losses $ 124 $ 9,577 (1) $ — $ (64 ) (1) $ 9,637 Allowance for chargebacks and other deductions $ 14,394 $ 90,237 (2) $ — $ (92,079 ) (2) $ 12,552 Deferred tax asset valuation allowance $ 120,805 $ — $ 30,059 (3) $ — $ 150,864 December 31, 2019 Provision for credit losses $ 9 $ 488 (1) $ — $ (373 ) (1) $ 124 Allowance for chargebacks and other deductions $ 13,101 $ 95,100 (2) $ — $ (93,807 ) (2) $ 14,394 Deferred tax asset valuation allowance $ 88,455 $ — $ 32,350 (3) $ — $ 120,805 December 31, 2018 Provision for credit losses $ 84 $ 28 (1) $ — $ (103 ) (1) $ 9 Allowance for chargebacks and other deductions $ 3,711 $ 36,102 (2) $ — $ (26,712 ) (2) $ 13,101 Deferred tax asset valuation allowance $ 60,379 $ — $ 28,076 (3) $ — $ 88,455 (1) Increases in the provision for credit losses consist of our provision for credit losses, which is included within selling, general, and administrative expenses on the consolidated statements of operations and comprehensive loss. Decreases in the provision for credit losses consist of the write-off of specific accounts and the recovery of previously reserved receivables. (2) Increases in the allowance for chargebacks and other deductions consist of our provision for chargebacks, cash discounts, returns, fees, and other credits, which are a deduction from product sales on the consolidated statements of operations and comprehensive loss. Decreases in the allowances for chargebacks and other deduction consist of the collection of the underlying accounts and advances received on chargebacks. ( 3 ) Increases and decreases in the valuation allowance for deferred income tax assets offset the increases and decreases in our gross deferred tax assets, based on the expected realization of those future tax benefits. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements reflect the accounts and operations of the Company and those of its subsidiaries in which the Company has a controlling financial interest. Intercompany transactions and balances have been eliminated. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amount of revenue and expenses during the reporting period. Such management estimates include those relating to assumptions used in clinical research accruals, chargebacks, measurement of acquired assets and assumed liabilities in business combinations, provision for credit losses, inventory reserves, deferred income taxes, the estimated useful life and recoverability of long-lived assets, and the valuation of stock-based awards and other items as appropriate. Actual results could differ from those estimates. |
Functional Currency | Functional Currency Assets and liabilities of subsidiaries that prepare financial statements in currencies other than the U.S. dollar are translated using rates of exchange as of the balance sheet date and the statements of operations and comprehensive loss are translated at the average rates of exchange for each reporting period. The Company recorded a foreign currency translation loss in accumulated other comprehensive loss of $0.5 million for the year ended December 31, 2020, a gain of $0.1 million for the year ended December 31, 2019 and a loss of $0.5 million for the year ended December 31, 2018. |
Cash, Cash Equivalents, Restricted Cash, and Short-term Investments | Cash, Cash Equivalents, Restricted Cash, and Short-term Investments The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. The Company deposits its cash primarily in checking, money market accounts, as well as short-term investments including certificates of deposit. Funds held in foreign accounts that are subject to regulations governing transfers oversees are included within cash and cash equivalents. As of December 31, 2020 and 2019, the Company had $42.5 million and $7.6 million, respectively, at its Chinese subsidiaries, which were subject to Chinese funds transfer limitations, but available for the Company’s general use. Restricted cash consists of deposits that are restricted as to their withdrawal or use. Restricted cash primarily include amounts held in a controlled bank account in connection with the Senior Credit Agreement. The Company generally does not enter into investments for trading or speculative purposes, rather to preserve its capital for the purpose of funding operations. |
Accounts Receivable, net | Accounts Receivable, net Accounts receivable are recorded at the invoiced amount. On a periodic basis, the Company evaluates its accounts receivable and establishes a provision for credit losses, based upon a history of past write-offs, the age of the receivables, and current credit conditions. |
Credit Losses | Credit Losses The Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables and contract assets recorded under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers To determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of customer, as the Company determined that risk profile of its customers is consistent based on the type and industry in which they operate. These customer classes include pharmaceutical wholesalers for specialty product sales, drug manufacturers for active pharmaceutical ingredient (API) sales, and hospitals and end-users for 503B sales. Each class of customer is analyzed for estimated credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available. Further, the Company considers macroeconomic factors and the status of the pharmaceutical industry, including unemployment rates, industry indices, and other factors, to estimate if there are current expected credit losses within its trade receivables based on the trends and the Company’s expectation of the future status of such economic and industry-specific factors. The Company believes that its customers, the majority of which are in the pharmaceutical industries with sound financial condition, and therefore, the Company’s evaluation of macroeconomic and industry-specific factors did not have a significant impact on the provision for credit losses. As of December 31, 2020 and 2019, the Company recorded a provision for credit losses of $0.7 million and $0.1 million, respectively, for accounts receivable related to the customer classes of pharmaceutical wholesalers, drug manufacturers, and hospitals and end users. Expected credit losses related to contract assets are evaluated on an individual basis. The Company’s contract assets relate to upfront fees or milestone payments due from licensees for which the underlying performance obligations have been satisfied. The Company evaluates the financial status of the licensee and any historical payment activity from them. Macroeconomic and industry-specific factors are considered when estimated current expected credit losses related to contract assets. Contract assets are generally classified as short-term, and the Company is in frequent communication with licensees to establish timely payment terms. If the Company expects that credit losses exist for license-related contract assets, it will record provision for such losses against the contract asset. As of December 31, 2019, the Company determined that credit losses related to its contract assets recognized in connection with its license arrangements were not expected to be significant. In the third quarter of 2020, pursuant to the 2019 Xiangxue License, the Company recognized $9.4 million license revenue, net of $0.6 million value added tax, for a milestone achievement. As of February 28, 2021, the Company only received $1.5 million of the $10.0 million milestone achievement. After consideration of historical collection rates, the current financial status of the counterparty, and other macroeconomic factors, the Company recorded a provision for its expected credit losses for the outstanding balance of $8.5 million and $0.4 million related to currency conversion in its consolidated financial statements for the three months and year ended December 31, 2020, respectively. |
Inventories | Inventories Prior to the regulatory approval of product candidates, the Company may incur expenses for the manufacture of drug product to support the commercial launch of those products. Until the date at which regulatory approval has been received or is otherwise considered probable, all such costs are recorded as research and development expenses as incurred. Inventories for special products and 503B products are stated at the lower of cost and net realizable value, with approximate cost being determined on a first-in-first-out basis. API inventory is stated at the lower of cost and net realizable value, with approximate cost being determined on a weighted average basis. The Company provides inventory write-downs based on excess and obsolete inventories determined primarily by future demand forecasts. The write-down is measured as the difference between the cost of the inventory and market, based upon assumptions about future demand, and is charged to the provision for inventory, which is a component of cost of sales. At the point of the loss recognition, a new, lower cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the restoration or increase in that newly established cost basis. Reserves for inventory amounted to $6.2 million and $9.0 million as of December 31, 2020 and 2019, respectively. |
Property and Equipment, net | Property and Equipment, net Property and equipment are recorded at cost or acquisition date fair value in a business acquisition. Depreciation is recorded over the estimated useful lives of the related assets using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the useful life or term of the lease. Upon retirement or disposal, the cost and related accumulated depreciation are removed from the consolidated balance sheets and the resulting gain or loss is recorded to general and administrative expense in the consolidated statements of operations and comprehensive loss. Routine expenditures for maintenance and repairs are expensed as incurred. Estimated useful lives for property and equipment are as follows: Property and Equipment Estimated Useful Life Land Not depreciated Equipment 5 - 8 years Furniture and fixtures 5 years Computer hardware 3 years Leasehold improvements Lesser of estimated useful life or remaining lease term Construction in process Not depreciated |
Leases | Leases On January 1, 2019, the Company adopted FASB Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) The lease liabilities are determined as the present value of future fixed minimum lease payments. In determining the discount rate, the Company uses rates implicit in the lease, or if not readily available, the Company uses an estimated incremental borrowing rate based on yield trends in the biotechnology and healthcare industry and debt instruments held by the Company with stated interest rates. The Company uses the stated rate per lease agreement in determining the finance lease liabilities. The lease term is determined at the commencement date and considers whether it is reasonably certain that the Company will exercise renewal options or termination options. The lease liabilities and ROU asset are amortized over the term of the lease with operating lease expenses being recognized on a straight-line basis over the lease terms. Leases with an initial lease term of 12 months or less are not recorded on the consolidated balance sheet. Lease expense for these leases is recognized on a straight-line basis over the lease term. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. Financial instruments consist of cash and cash equivalents, restricted cash, short-term investments, accounts receivable, other current assets, accounts payable, accrued expenses, and other. These financial instruments are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. |
Goodwill | Goodwill The Company tests goodwill for impairment annually on October 1 st |
Intangible Assets, net | Intangible Assets, net Intangible assets arising from a business acquisition are recognized at fair value as of the acquisition date. The Company amortizes intangible assets using the straight-line method. When the straight-line method of amortization is utilized, the estimated useful life of the intangible asset is shortened to assure the recognition of amortization expense corresponds with the expected cash flows. Other purchased intangibles, including certain licenses, are capitalized at cost and amortized on a straight-line basis over the license life, when a future economic benefit is probable and measurable. If a future economic benefit is not probable or measurable, the license costs are expensed as incurred within research and development expenses. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Goodwill and Intangible Assets, net |
Treasury Stock | Treasury Stock The Company records treasury stock activities at the cost of the acquired stock. The Company’s accounting policy upon the formal retirement of treasury stock is to deduct the par value from common stock and to reflect any excess of cost over par value as a reduction to additional paid-in capital (to the extent created by previous issuances of the stock) and then accumulated deficit. |
Revenue Recognition | Revenue Recognition Effective January 1, 2018, the Company adopted ASC, Topic 606, “ Revenue from Contracts with Customers Revenue Recognition |
Research and Development Expenses | Research and Development Expenses Costs for research and development (“R&D”) of products, including payroll, contractor expenses, and supplies, are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development arrangements, the obligations are recorded when the milestone results are probable of being achieved. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Changes in unrealized gains and losses on investments and foreign currency translation adjustments represent the differences between the Company’s net loss and comprehensive loss. |
Stock-Based Compensation | Stock-Based Compensation Awards granted to employees The Company recognizes stock-based compensation based on the grant date fair value of stock options granted to employees, officers, and directors. The Company used the Black-Scholes option pricing model to calculate the grant date fair value of stock options. The Black-Scholes option pricing model requires inputs for risk-free interest rate, dividend yield, volatility, fair value of common stock, and expected lives of the stock options. The risk-free rate for periods within the expected life of the stock option is based on the U.S. Treasury yield curve in effect at the time of the grant. No dividend yield is used, consistent with the Company’s history. Expected volatility is based on historical volatilities of the stock prices of peer biopharmaceutical companies. The fair value of common stock is based on the quoted market price of the Company’s common stock on grant date. The Company uses the simplified method for determining the expected lives of stock options. The Company recognizes compensation expenses based on the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting period. Stock grants The Company grants common stock to key officers and directors and records the fair value of these grants, based on the fair value of the common stock on the grant date, as compensation expense throughout the requisite service period. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Deferred income tax assets and liabilities are recognized for the estimated future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred income tax expense or benefit is the result of changes in the deferred income tax assets and liabilities. Valuation allowances are established when necessary to reduce deferred income tax assets where, based upon the available evidence, management concludes that it is more-likely-than not that the deferred income tax assets will not be realized. In evaluating its ability to recover deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, ongoing tax planning and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis. Because of the uncertainty of the realization of the deferred income tax assets, the Company has recorded a valuation allowance against its deferred income tax assets. Reserves are provided for tax benefits for which realization is uncertain. Such benefits are only recognized when the underlying tax position is considered more likely than not to be sustained on examination by a taxing authority, assuming they possess full knowledge of the position and facts. Interest and penalties related to uncertain tax positions are recognized in income tax expense; however, the Company currently has no interest or penalties related to income taxes. |
Segment and Geographic Information | Segment and Geographic Information The Company’s chief operating decision-maker, its Chief Executive Officer, reviews its operating results on an aggregate basis and at the operating segment level for purposes of allocating resources and evaluating financial performance. The Company has three business platforms which are the operating segments: (1) Oncology Innovation Platform, for the discovery and development of cancer supportive therapies, (2) Commercial Platform, the manufacturing and selling of commercial pharmaceutical products, and (3) Global Supply Chain Platform, the cGMP manufacturing and marketing of API, and clinical products. Each operating segment has a segment manager who is held accountable for operations and operating results. Accordingly, the Company operates in three reportable segments. |
Concentration of Credit Risk, Other Risks and Uncertainties | Concentration of Credit Risk, Other Risks and Uncertainties Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, and short-term investments. The Company deposits its cash equivalents in interest-bearing money market accounts and certificates of deposit and invests in highly liquid U.S. Treasury notes, commercial paper, and corporate bonds. The Company deposits its cash with multiple financial institutions. Cash balances exceed federally insured limits. The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer and establishing a minimum allowable credit rating. The Company also has significant assets and liabilities held in its overseas manufacturing facility, and research and development facility in China, and therefore is subject to foreign currency fluctuation and regulatory uncertainties. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, “ Measurement of Credit Losses on Financial Instruments” |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Property, Plant and Equipment, Useful Life | Estimated useful lives for property and equipment are as follows: Property and Equipment Estimated Useful Life Land Not depreciated Equipment 5 - 8 years Furniture and fixtures 5 years Computer hardware 3 years Leasehold improvements Lesser of estimated useful life or remaining lease term Construction in process Not depreciated |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following (in thousands): December 31, 2020 2019 Raw materials and purchased parts $ 6,498 $ 4,176 Work in progress 776 1,870 Finished goods 21,572 26,584 Total inventories $ 28,846 $ 32,630 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property and equipment, net, consists of the following (in thousands): December 31, 2020 2019 Land $ 1,190 $ 1,117 Equipment 11,353 6,724 Furniture and fixtures 933 578 Computer hardware 4,183 3,142 Leasehold improvements 2,933 2,792 Construction in process 22,514 14,758 Property and equipment, gross 43,106 29,111 Less: accumulated depreciation (8,718 ) (5,958 ) Property and equipment, net $ 34,388 $ 23,153 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Changes in Carrying Amount of Goodwill for each Reporting Unit | The changes in the carrying amount of goodwill for each reporting unit to which goodwill is assigned for the periods indicated are as follows (in thousands): Global Supply Chain Oncology Innovation Platform Total Balance as of January 1, 2019 $ 26,233 $ 11,262 $ 37,495 Goodwill acquired — 1,018 1,018 Effect of currency translation adjustment (64 ) 64 — Balance as of December 31, 2019 26,169 12,344 38,513 Effect of currency translation adjustment 327 51 378 Balance as of December 31, 2020 $ 26,496 $ 12,395 $ 38,891 |
Summary of Identifiable Intangible Asset, Net | The Company’s identifiable intangible assets, net, consist of the following (in thousands): December 31, 2020 Cost/Fair Value Accumulated Amortization Impairments Net Amortizable intangible assets Licenses $ 12,641 $ 5,157 $ — $ 7,484 Polymed customer list 1,593 1,418 — 175 Polymed technology 3,712 1,685 — 2,027 Indefinite-lived intangible assets: CDE in-process research and development (IPR&D) 728 — — 728 Effect of currency translation adjustment (196 ) — — (196 ) Total intangibles, net $ 18,478 $ 8,260 $ — $ 10,218 December 31, 2019 Cost/Fair Value Accumulated Amortization Impairments Net Amortizable intangible assets Licenses $ 8,935 $ 3,561 $ — $ 5,374 Polymed customer list 1,593 1,164 — 429 Polymed technology 3,712 1,297 — 2,415 Product rights 530 360 170 — Indefinite-lived intangible assets: CDE in-process research and development (IPR&D) 728 — — 728 Effect of currency translation adjustment (424 ) — — (424 ) Total intangibles, net $ 15,074 $ 6,382 $ 170 $ 8,522 |
Schedule of Expected Amortization Expense of Finite-Lived Intangible Assets | The Company expects amortization expense related to its finite-lived intangible assets for the next 5 years and thereafter to be as follows as of December 31, 2020 (in thousands): Year ending December 31: Estimated Amortization Expense 2021 $ 2,653 2022 1,834 2023 1,805 2024 1,430 2025 1,388 Thereafter 576 $ 9,686 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following tables represent the fair value hierarchy for those assets and liabilities that the Company measures at fair value on a recurring basis (in thousands): Fair Value Measurements at December 31, 2020 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Financial assets included within cash and cash equivalents Money market funds $ 5,615 $ 5,615 $ — $ — Short-term investments - certificates of deposit 4,070 — 4,070 — Short-term investments - U.S. government bonds 5,000 — 5,000 — Short-term investments - commercial paper 34,860 — 34,860 — Financial assets included within short-term investments Short-term investments - certificates of deposit 20,696 — 20,696 — Short-term investments - U.S. government bonds 14,998 — 14,998 — Short-term investments - commercial paper 102,715 — 102,715 — Available-for-sale investment 227 227 — — Total assets $ 188,181 $ 5,842 $ 182,339 $ — Fair Value Measurements at December 31, 2019 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Financial assets included within cash and cash equivalents Money market funds $ 5,460 $ 5,460 $ — $ — Short-term investments - certificates of deposit 15,110 — 15,110 — Short-term investments - commercial paper 51,017 — 51,017 — Financial assets included within short-term investments Short-term investments - certificates of deposit 10,054 — 10,054 — Short-term investments - commercial paper 22,835 — 22,835 — Available-for-sale investment 250 250 — — Total assets $ 104,726 $ 5,710 $ 99,016 $ — |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2020 2019 Accrued selling fees, rebates, and royalties $ 9,046 $ 1,577 Accrued wages and benefits 6,720 7,541 Accrued construction costs 4,104 22,811 Accrued inventory purchases 3,714 7,194 Accrued interest 3,583 — Accrued operating expenses 3,222 1,885 Accrued clinical expenses 2,949 2,510 Accrued tax withholdings 1,948 187 Accrued costs for product launch 1,474 — Deferred revenue 1,147 218 Accrued R&D licensing fees 366 384 Total accrued expenses $ 38,273 $ 44,307 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Tax Expense | The components of loss before income tax expense consist of the following (in thousands): Year Ended December 31, 2020 2019 2018 Domestic $ (133,929 ) $ (109,769 ) $ (95,479 ) Foreign (10,417 ) (14,836 ) (33,132 ) $ (144,346 ) $ (124,605 ) $ (128,611 ) |
Components of the Income Tax Expense | The components of the income tax expense consist of the following (in thousands): Year Ended December 31, 2020 2019 2018 Current: Federal $ — $ — $ — State 4 23 27 Foreign 4,026 419 455 4,030 442 482 Deferred: Federal (27,279 ) (26,878 ) (26,260 ) State (916 ) (2,567 ) (293 ) Foreign (1,424 ) (2,411 ) (1,863 ) (29,619 ) (31,856 ) (28,416 ) Change in valuation allowance 29,677 32,342 28,034 $ 4,088 $ 928 $ 100 |
Schedule of Income Tax Expense Differs From the Federal Statutory Rate | The income tax expense differs from the federal statutory rate due to the following: Year Ended December 31, 2020 2019 2018 Statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 0.7 2.0 0.2 Foreign rate differential 0.1 0.1 (0.3 ) Valuation allowance (20.3 ) (25.9 ) (21.6 ) Stock-based compensation (2.6 ) — — Foreign tax withholdings (2.3 ) (0.2 ) — Other 0.6 1.9 0.6 (2.8 )% (0.7 )% (0.1 )% |
Schedule of Net Deferred Income Tax Liabilities | Net deferred income tax liabilities consist of the following (in thousands): December 31, 2020 2019 Intangible assets $ 11,372 $ 11,348 Property and equipment 51 77 Stock-based compensation 7,148 9,551 Net operating loss carryforwards 106,342 81,630 Tax credit carryforwards 13,528 9,191 Research and development deduction 1,859 1,493 Reserves and accruals 11,472 8,377 Gross deferred income tax assets 151,772 121,667 Less: valuation allowance (150,864 ) (120,805 ) Net deferred income tax assets 908 862 Intangible assets (821 ) (862 ) Property and equipment (143 ) — Gross deferred income tax liabilities (964 ) (862 ) Net deferred income tax liabilities $ (56 ) $ — |
Debt and Lease Obligations (Tab
Debt and Lease Obligations (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt And Lease Obligations [Abstract] | |
Schedule of Debt | The Company’s debt as of December 31, 2020 and 2019, consists of the following (in thousands): December 31, 2020 2019 Current portion of mortgage $ 731 $ 686 Current portion of bank loan 764 — Current portion of senior secured loan 70 — Current portion of finance lease obligations 445 194 Current portion of operating lease obligations 3,185 3,010 Long-term portion of finance lease obligations 537 227 Long-term portion of operating lease obligations 6,355 7,620 Chongqing Maliu credit agreement 7,641 5,731 Senior secured loan, net of debt discount and financing fees of $11,601 and $3,592, respectively 138,399 46,408 Total $ 158,127 $ 63,876 |
Summary of Components of Lease Expense | The components of lease expense are as follows (in thousands): Year Ended December 31, 2020 Year Ended December 31, 2019 Operating lease cost $ 3,041 $ 3,162 Finance lease cost: Amortization of assets 238 81 Interest on lease liabilities 73 31 Total net lease cost $ 3,352 $ 3,274 |
Schedule of Supplemental Balance Sheet Information Related to Leases of Debt | Supplemental balance sheet information related to leases is as follows (in thousands, except lease term and discount rate): December 31, 2020 December 31, 2019 Finance leases: Property and equipment, at cost $ 1,535 $ 688 Accumulated amortization, net (347 ) (109 ) Property and equipment, net $ 1,188 $ 579 Current obligations of finance leases $ 445 $ 194 Long-term portion of finance leases 537 227 Total finance lease obligations $ 982 $ 421 Weighted average remaining lease term (in years): Operating leases 4.23 5.21 Finance leases 3.40 2.11 Weighted average discount rate: Operating leases 12.8 % 12.9 % Finance leases 10.4 % 5.9 % |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases is as follows (in thousands): Year Ended December 31, 2020 Cash paid for amount included in the measurements of lease liabilities: Operating cash flows from operating leases $ (3,304 ) Operating cash flows from finance leases (286 ) Financing cash flows from finance leases (73 ) ROU assets recognized in exchange for new operating lease obligations $ 852 |
Schedule of Future Minimum Payments and Maturities of Leases | Future minimum payments and maturities of leases is as follows (in thousands): Year ending December 31: Operating Leases Finance Leases 2021 $ 3,454 $ 468 2022 2,927 275 2023 2,096 248 2024 2,002 177 2025 1,472 — Thereafter 478 — Total lease payments 12,429 1,168 Less: Imputed interest (2,889 ) (186 ) Total lease obligations 9,540 982 Less: Current obligations (3,185 ) (445 ) Long-term lease obligations $ 6,355 $ 537 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes the status of the Company’s stock option activity granted under the Plans and 2017 Plan to employees, directors, and consultants (in thousands, except stock option amounts): Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2019 10,916,936 $ 8.88 6.87 $ 69,785 Granted 1,970,972 11.46 — — Exercised (238,630 ) 7.23 — — Forfeited and expired (152,390 ) 13.31 — — Outstanding at December 31, 2020 12,496,888 $ 9.26 5.42 $ 22,463 Vested and exercisable at December 31, 2020 9,126,142 $ 7.89 4.29 $ 28,936 |
Schedule of Weighted-Average Assumptions Used as Inputs to Black-Scholes Option Pricing Model | The Company determines the fair value of stock option awards on the grant date using the Black-Scholes option pricing model, which is impacted by assumptions regarding a number of highly subjective variables. The following table summarizes the weighted-average assumptions used as inputs to the Black-Scholes option pricing model during the periods indicated: Year Ended December 31, 2020 2019 2018 Weighted average grant date fair value $ 6.93 $ 8.06 $ 9.80 Expected dividend yield — % — % — % Expected stock price volatility 67 % 64 % 59 % Risk-free interest rate 0.91 % 2.60 % 2.61 % Expected life of options (in years) 6.2 6.3 6.1 |
Schedule of Stock-Based Compensation Cost | The components of stock-based compensation and the amounts recorded within research and development expenses and selling, general, and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss consisted of the following for the years ended December 31, 2020, 2019, and 2018 (in thousands): Year Ended December 31, 2020 2019 2018 Stock options $ 9,557 $ 7,887 $ 9,786 Restricted stock expense 1,017 566 1,008 Stock awarded to directors and officers — 1,105 — Employee stock purchase plan 276 327 217 Total stock-based compensation expense $ 10,850 $ 9,885 $ 11,011 Cost of sales $ 249 $ 248 $ 228 Research and development expenses 3,647 3,251 2,621 Selling, general, and administrative expenses 6,954 6,386 8,162 Total stock-based compensation expense $ 10,850 $ 9,885 $ 11,011 |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Athenex, Inc. Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule Weighted Average Outstanding Shares of Common Stock Equivalents Excluded from the Calculation of Diluted Net Loss Per Share | The following weighted average outstanding shares of common stock equivalents were excluded from the calculation of diluted net loss per share attributable Athenex, Inc. to common stockholders for the periods presented because including them would have been antidilutive: Year Ended December 31, 2020 2019 2018 Stock options and other common stock equivalents 12,748,882 10,814,635 10,480,084 Unvested restricted common shares 76,750 45,581 113,260 Total potential dilutive common shares 12,825,632 10,860,216 10,593,344 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Schedule of Components and Changes of Accumulated Other Comprehensive Loss | The components and changes of accumulated other comprehensive loss, net of related income tax effects, are as follows (in thousands): Balance as of January 1, 2018 $ (146 ) Foreign currency translation adjustment (525 ) Unrealized gain on investment 15 Balance as of December 31, 2018 (656 ) Foreign currency translation adjustment 118 Unrealized loss on investment (97 ) Balance as of December 31, 2019 (635 ) Foreign currency translation adjustment (494 ) Unrealized loss on investment (5 ) Balance as of December 31, 2020 $ (1,134 ) |
Business Segment, Geographic,_2
Business Segment, Geographic, and Concentration Risk Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Segment Reporting [Abstract] | |
Summary of Revenue by Segments | Segment information is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Total revenue: Oncology Innovation Platform $ 38,851 $ 20,562 $ 32,776 Global Supply Chain Platform 20,491 33,970 31,274 Commercial Platform 89,572 50,427 30,426 Total revenue for reportable segments 148,914 104,959 94,476 Intersegment revenue (4,523 ) (3,730 ) (5,376 ) Total consolidated revenue $ 144,391 $ 101,229 $ 89,100 |
Summary of Revenue by Product Group | Year Ended December 31, 2020 2019 2018 Total revenue by product group: Commercial product sales $ 101,590 $ 67,411 $ 35,640 License fees 38,827 20,100 32,000 API sales 3,599 12,733 17,952 Contract manufacturing revenue 85 391 458 Medical device sales — — 2,344 Other revenue 290 594 706 Total consolidated revenue $ 144,391 $ 101,229 $ 89,100 |
Summary of Segment Information | Year Ended December 31, 2020 2019 2018 Net loss attributable to Athenex, Inc.: Oncology Innovation Platform $ (89,189 ) $ (100,919 ) $ (89,912 ) Global Supply Chain Platform (19,400 ) (8,575 ) (16,858 ) Commercial Platform (37,590 ) (14,255 ) (10,670 ) Total consolidated net loss attributable to Athenex, Inc. $ (146,179 ) $ (123,749 ) $ (117,440 ) |
Summary of Depreciation, Amortization and Assets by Segment | Year Ended December 31, 2020 2019 2018 Total depreciation and amortization Oncology Innovation Platform $ 776 $ 762 $ 690 Global Supply Chain Platform 2,048 1,489 1,603 Commercial Platform 1,668 1,566 976 Total consolidated depreciation and amortization $ 4,492 $ 3,817 $ 3,269 December 31, 2020 2019 Total assets: Oncology Innovation Platform $ 234,153 $ 194,183 Global Supply Chain Platform 99,087 63,598 Commercial Platform 51,089 52,151 Total assets $ 384,329 $ 309,932 |
Summary of Revenue by Geographical Segment | Year Ended December 31, 2020 2019 2018 Total revenue United States $ 82,362 $ 67,794 $ 37,904 China 39,796 2,105 4,416 United Kingdom 19,289 1,023 — South Korea 2,354 513 — Austria 226 4,422 9,569 India — 3,066 3,457 Spain — 20,000 30,000 Other foreign countries 364 2,306 3,754 Total consolidated revenue $ 144,391 $ 101,229 $ 89,100 |
Summary of Property and Equipment by Geographical Segment | December 31, 2020 2019 Total property and equipment, net: United States $ 15,511 $ 11,486 China 18,877 11,667 Total property and equipment, net $ 34,388 $ 23,153 |
Summary of Customer Revenue and Accounts Receivable Concentration | Customer revenue and accounts receivable concentration amounted to the following for the identified periods: Year Ended December 31, 2020 2019 2018 Percentage of total revenue by customer: Customer A 26 % — — Customer B 14 % 15 % 9 % Customer C 14 % 16 % 12 % Customer D 13 % — — Customer E 10 % 14 % 9 % Customer F — 20 % 34 % December 31, 2020 2019 Percentage of total accounts receivable by customer: Customer A 33 % 45 % Customer B 23 % 31 % Customer C 16 % 10 % |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Company's Revenue for Reportable Segment by Country Based on Locations of Customer | Disaggregation of revenue The following represents the Company’s revenue for its reportable segment by country, based on the locations of the customer (in thousands). For the Year Ended December 31, 2020 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 12,079 $ 70,283 $ 82,362 China 38,760 1,036 — 39,796 United Kingdom — — 19,289 19,289 South Korea — 2,354 — 2,354 Other Foreign Countries 91 499 — 590 Total Revenue $ 38,851 $ 15,968 $ 89,572 $ 144,391 For the Year Ended December 31, 2019 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 17,367 $ 50,427 $ 67,794 Spain 20,000 — — 20,000 Austria — 4,422 — 4,422 India — 3,066 — 3,066 China 562 1,543 — 2,105 United Kingdom — 1,023 — 1,023 Other Foreign Countries — 2,819 — 2,819 Total Revenue $ 20,562 $ 30,240 $ 50,427 $ 101,229 For the Year Ended December 31, 2018 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 7,478 $ 30,426 $ 37,904 Spain 30,000 — — 30,000 Austria — 9,569 — 9,569 China 2,776 1,640 — 4,416 India — 3,457 — 3,457 Other Foreign Countries — 3,754 — 3,754 Total Revenue $ 32,776 $ 25,898 $ 30,426 $ 89,100 |
Summary of Receivables and Contract Liabilities From Contracts with Customers | The following table provides information about receivables and contract liabilities from contracts with customers. The Company has not recorded any contract assets from contracts with customers (in thousands). December 31, 2020 2019 Accounts receivable, gross $ 45,792 $ 31,207 Chargebacks and other deductions (12,552 ) (14,394 ) Provision for credit losses (9,637 ) (124 ) Accounts receivable, net $ 23,603 $ 16,689 Deferred revenue 1,147 218 Total contract liabilities $ 1,147 $ 218 |
Summary of Accounts Receivable by Reportable Segments | The following tables illustrate accounts receivable by reportable segments (in thousands). December 31, 2020 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 10,783 $ 4,074 $ 30,935 $ 45,792 Chargebacks and other deductions — (1 ) (12,551 ) (12,552 ) Provision for credit losses (8,919 ) (164 ) (554 ) (9,637 ) Accounts receivable, net $ 1,864 $ 3,909 $ 17,830 $ 23,603 December 31, 2019 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 49 $ 1,522 $ 29,636 $ 31,207 Chargebacks and other deductions — (1 ) (14,393 ) (14,394 ) Provision for credit losses — (114 ) (10 ) (124 ) Accounts receivable, net $ 49 $ 1,407 $ 15,233 $ 16,689 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Unaudited Quarterly Results of Operations | The following tables present our unaudited quarterly results of operations for each quarter within the two most recent fiscal years. This unaudited quarterly information has been prepared on the same basis as our audited consolidated financial statements and, in the opinion of management, the statement of operations data includes all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the results of operations for these periods. The results of operations for any quarter are not necessarily indicative of the results of operations for any future periods. Fiscal 2020 Quarter Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 (In thousands, except per share data) Statements of Operations Data: Revenue: Product sales $ 18,547 $ 40,167 $ 24,780 $ 21,780 License and other revenue 28,388 5 10,696 28 Total revenue 46,935 40,172 35,476 21,808 Cost of sales 19,572 33,006 24,510 18,267 Gross profit 27,363 7,166 10,966 3,541 Operating expenses: Research and development expenses 17,192 22,015 18,390 18,307 Selling, general, and administrative expenses 25,748 17,486 22,220 31,401 Total operating expenses 42,940 39,501 40,610 49,708 Operating loss (15,577 ) (32,335 ) (29,644 ) (46,167 ) Net loss (19,718 ) (41,051 ) (37,268 ) (50,397 ) Less: net loss attributable to non-controlling interests (289 ) (600 ) (462 ) (904 ) Net loss attributable to Athenex, Inc. $ (19,429 ) $ (40,451 ) $ (36,806 ) $ (49,493 ) Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted $ (0.24 ) $ (0.50 ) $ (0.44 ) $ (0.53 ) Fiscal 2019 Quarter Ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 (In thousands, except per share data) Statements of Operations Data: Revenue: Product sales $ 25,163 $ 22,033 $ 19,237 $ 14,102 License and other revenue 144 164 127 20,259 Total revenue 25,307 22,197 19,364 34,361 Cost of sales 19,902 16,942 17,071 15,704 Gross profit 5,405 5,255 2,293 18,657 Operating expenses: Research and development expenses 24,475 18,507 19,588 21,823 Selling, general, and administrative expenses 15,188 17,169 16,283 18,109 Total operating expenses 39,663 35,676 35,871 39,932 Operating loss (34,258 ) (30,421 ) (33,578 ) (21,275 ) Net loss (36,230 ) (32,105 ) (34,787 ) (22,411 ) Less: net loss attributable to non-controlling interests (997 ) (74 ) (29 ) (684 ) Net loss attributable to Athenex, Inc. $ (35,233 ) $ (32,031 ) $ (34,758 ) $ (21,727 ) Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted $ (0.53 ) $ (0.44 ) $ (0.45 ) $ (0.28 ) |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Payments Under Non-Cancelable Leases | Future minimum payments under the non-cancelable operating leases consists of the following as of December 31, 2020 (in thousands): Year ending December 31: Minimum payments 2021 $ 3,454 2022 2,927 2023 2,096 2024 2,002 2025 1,472 Thereafter 478 $ 12,429 |
Company and Nature of Business
Company and Nature of Business - Additional Information (Detail) | Aug. 04, 2020USD ($)$ / sharesshares | Jun. 19, 2020USD ($)Tranche$ / sharesshares | Dec. 09, 2019USD ($)$ / sharesshares | May 07, 2019USD ($)$ / sharesshares | Jul. 03, 2018USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Feb. 28, 2018USD ($)$ / sharesshares | Jan. 31, 2018$ / sharesshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Aug. 04, 2026USD ($) | Sep. 30, 2024USD ($) |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Net proceeds from stock issuance | $ 126,980,000 | $ 161,080,000 | $ 123,134,000 | ||||||||||
Loss on extinguishment of debt | 10,278,000 | ||||||||||||
Sale of common stock | $ 118,700,000 | 119,110,000 | 159,977,000 | 117,616,000 | |||||||||
Private placement closing date | Dec. 9, 2019 | May 7, 2019 | |||||||||||
Payments for offering expenses | 7,869,000 | 1,103,000 | $ 5,518,000 | ||||||||||
Accumulated deficit | (713,644,000) | (567,465,000) | |||||||||||
Cash and cash equivalents | 69,587,000 | 127,674,000 | |||||||||||
Restricted cash | 16,500,000 | ||||||||||||
Short-term investments | $ 138,636,000 | $ 33,139,000 | |||||||||||
Private Financing Transactions | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Warrants to purchase common stock outstanding | shares | 425,000 | ||||||||||||
Purchase price | $ / shares | $ 18.66 | ||||||||||||
Perceptive | Private Financing Transactions | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Number of shares issued and sold | shares | 2,679,528 | ||||||||||||
Common stock share price | $ / shares | $ 18.66 | ||||||||||||
Gross proceeds from debt and equity financing | $ 100,000,000 | ||||||||||||
Aggregate net proceeds of debt and equity financing, net of fees and offering expenses | 97,100,000 | ||||||||||||
Sale of common stock | 50,000,000 | ||||||||||||
Common Stock | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Number of shares issued and sold | shares | 11,607,322 | 14,006,575 | 7,486,261 | ||||||||||
Sale of common stock | $ 11,000 | $ 14,000 | $ 7,000 | ||||||||||
Senior Secured Loan | Perceptive | Private Financing Transactions | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Term loans and commitments | $ 50,000,000 | ||||||||||||
Debt instrument maturity term | 5 years | ||||||||||||
Senior Secured Loan | LIBOR | Perceptive | Private Financing Transactions | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Debt variable rate basis floor | 2.00% | ||||||||||||
Basis spread on variable rate | 9.00% | ||||||||||||
Sagard and IMCO Investors | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Warrants to purchase common stock outstanding | shares | 201,865 | ||||||||||||
Purchase price | $ / shares | $ 12.63 | ||||||||||||
Sagard and IMCO Investors | Senior Loan | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Loss on extinguishment of debt | $ 3,000,000 | ||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Licenses revenue | $ 50,000,000 | ||||||||||||
Payment percentage of world-wide net sales | 5.00% | ||||||||||||
Percentage of product payment | 170.00% | ||||||||||||
Payments due to related parties | $ 85,000,000 | ||||||||||||
Percentage of internal rate of return | 6.00% | ||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | Scenario Forecast | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Payments due to related parties | $ 50,000,000 | $ 20,000,000 | |||||||||||
Senior Credit Agreement | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Loss on extinguishment of debt | $ 7,200,000 | ||||||||||||
Senior Credit Agreement, maximum borrowing capacity | $ 225,000,000 | ||||||||||||
Number of tranches | Tranche | 5 | ||||||||||||
Senior Credit Agreement, maturity date | Jun. 19, 2026 | Jun. 19, 2026 | |||||||||||
Bearing interest at a fixed annual rate | 11.00% | ||||||||||||
Senior Credit Agreement, additional debt tranches available | $ 75,000,000 | ||||||||||||
Senior Credit Agreement | Common Stock | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Purchase price | $ / shares | $ 12.63 | ||||||||||||
Senior Credit Agreement | Common Stock | Maximum | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Warrant to purchase common stock | shares | 908,393 | ||||||||||||
Senior Credit Agreement | Tranche A | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Senior Credit Agreement, amount drawn | $ 100,000,000 | ||||||||||||
Senior Credit Agreement | Tranche B | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Senior Credit Agreement, amount drawn | 25,000,000 | ||||||||||||
Senior Credit Agreement | Tranche C | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Senior Credit Agreement, amount drawn | $ 25,000,000 | ||||||||||||
Senior Credit Agreement | Sagard and IMCO Investors | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Term loans and commitments | $ 50,000,000 | ||||||||||||
Underwriters | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Number of shares issued and sold | shares | 11,500,000 | 4,300,000 | |||||||||||
Number of additional common stock shares purchase | shares | 1,500,000 | 465,000 | 645,000 | ||||||||||
Common stock share price | $ / shares | $ 11 | $ 15.25 | $ 15.25 | ||||||||||
Net proceeds from stock issuance | $ 118,700,000 | $ 68,100,000 | |||||||||||
Underwriting discounts and commissions | $ 7,900,000 | $ 4,600,000 | |||||||||||
Number of days granted to underwriters option to purchase additional shares | 30 days | ||||||||||||
Private Placement | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Common stock share price | $ / shares | $ 15.30 | $ 10 | |||||||||||
Net proceeds from issuance of private placement | $ 59,400,000 | $ 99,900,000 | |||||||||||
Payments for offering expenses | $ 1,000,000 | $ 100,000 | |||||||||||
Private Placement | Common Stock | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||||||
Number of shares issued and sold | shares | 3,945,750 | 10,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Feb. 28, 2021USD ($) | Jan. 01, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020USD ($)SegmentReporting_Unit | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Foreign currency translation adjustment, net of income taxes | $ (494,000) | $ 118,000 | $ (525,000) | |||
Provision for credit losses | $ 9,637,000 | 9,637,000 | 124,000 | |||
Value added tax | 2,300,000 | |||||
Reserves on inventory | $ 6,200,000 | $ 6,200,000 | 9,000,000 | |||
Number of operating segments | Segment | 3 | |||||
Goodwill, impairment loss | $ 0 | 0 | 0 | |||
Number of reporting units | Reporting_Unit | 2 | |||||
Impairment of long-lived assets held-for-use | $ 0 | $ 200,000 | $ 300,000 | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |||
Interest or penalties related to income taxes | $ 0 | |||||
Accounting standards adopted | true | true | ||||
Accounting standards adoption date | Jan. 1, 2020 | Jan. 1, 2020 | ||||
Accounting Standards Update Extensible List | us-gaap:AccountingStandardsUpdate201613Member | us-gaap:AccountingStandardsUpdate201613Member | ||||
Adjustment to provision for credit losses | $ 0 | |||||
Cumulative-effect adjustment to retained earnings | $ 0 | |||||
Xiangxue License | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Provision for expected credit losses related to currency conversion | $ 8,500,000 | $ 400,000 | ||||
Xiangxue License | Subsequent Event | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Payments received on milestone achievement | $ 1,500,000 | |||||
Aggregate payments to be received upon milestone achievement | $ 10,000,000 | |||||
License Revenue | Xiangxue License | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Revenue recognized | 9,400,000 | |||||
Value added tax | 600,000 | |||||
Pharmaceutical Wholesalers, Drug Manufacturers, and Hospitals and End Users | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Provision for credit losses | 700,000 | 700,000 | $ 100,000 | |||
Chinese Subsidiaries | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Cash and cash equivalents, funds transfer limitations | $ 42,500,000 | $ 42,500,000 | $ 7,600,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property, Plant and Equipment, Useful Life (Detail) | 12 Months Ended |
Dec. 31, 2020 | |
Land | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | Not depreciated |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | 5 years |
Computer hardware | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | 3 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | Lesser of estimated useful life or remaining lease term |
Construction in process | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | Not depreciated |
Minimum [Member] | Equipment | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | 5 years |
Maximum | Equipment | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, Estimated Useful Life | 8 years |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Restricted Cash [Line Items] | |
Restricted cash | $ 16,500 |
Senior Credit Agreement | |
Restricted Cash [Line Items] | |
Restricted cash | $ 16,500 |
Period of interest on outstanding loans to be maintained in debt service reserve account | 12 months |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials and purchased parts | $ 6,498 | $ 4,176 |
Work in progress | 776 | 1,870 |
Finished goods | 21,572 | 26,584 |
Total inventories | $ 28,846 | $ 32,630 |
Property And Equipment, Net - S
Property And Equipment, Net - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Abstract] | ||
Land | $ 1,190 | $ 1,117 |
Equipment | 11,353 | 6,724 |
Furniture and fixtures | 933 | 578 |
Computer hardware | 4,183 | 3,142 |
Leasehold improvements | 2,933 | 2,792 |
Construction in process | 22,514 | 14,758 |
Property and equipment, gross | 43,106 | 29,111 |
Less: accumulated depreciation | (8,718) | (5,958) |
Property and equipment, net | $ 34,388 | $ 23,153 |
Property And Equipment, Net - A
Property And Equipment, Net - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||
Depreciation Expense | $ 2.6 | $ 2 | $ 1.7 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets, Net - Goodwill (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill [Line Items] | ||
Beginning Balance | $ 38,513 | $ 37,495 |
Goodwill acquired | 1,018 | |
Effect of currency translation adjustment | 378 | |
Ending Balance | 38,891 | 38,513 |
Global Supply Chain Platform | ||
Goodwill [Line Items] | ||
Beginning Balance | 26,169 | 26,233 |
Effect of currency translation adjustment | 327 | (64) |
Ending Balance | 26,496 | 26,169 |
Oncology Innovation Platform | ||
Goodwill [Line Items] | ||
Beginning Balance | 12,344 | 11,262 |
Goodwill acquired | 1,018 | |
Effect of currency translation adjustment | 51 | 64 |
Ending Balance | $ 12,395 | $ 12,344 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets, Net - Summary of Identifiable Intangible Asset, Net (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule Of Finite And Indefinite Lived Intangible Assets [Line Items] | ||
Finite-lived intangible asset, Accumulated Amortization | $ 8,260,000 | $ 6,382,000 |
Finite-lived intangible asset, Net | 9,686,000 | |
Intangible asset, Effect of currency translation adjustment | (196,000) | (424,000) |
Intangible assets Cost/Fair Value | 18,478,000 | 15,074,000 |
Intangible assets Impairments | 170,000 | |
Intangible assets, net | 10,218,000 | 8,522,000 |
CDE In- Process Research and Development | ||
Schedule Of Finite And Indefinite Lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible asset, Cost/Fair Value | 728,000 | 728,000 |
Indefinite-lived intangible asset, Net | 728,000 | 728,000 |
Intangible assets Impairments | 0 | |
Licenses | ||
Schedule Of Finite And Indefinite Lived Intangible Assets [Line Items] | ||
Finite-lived intangible asset, Cost/Fair Value | 12,641,000 | 8,935,000 |
Finite-lived intangible asset, Accumulated Amortization | 5,157,000 | 3,561,000 |
Finite-lived intangible asset, Net | 7,484,000 | 5,374,000 |
Polymed Customer List | ||
Schedule Of Finite And Indefinite Lived Intangible Assets [Line Items] | ||
Finite-lived intangible asset, Cost/Fair Value | 1,593,000 | 1,593,000 |
Finite-lived intangible asset, Accumulated Amortization | 1,418,000 | 1,164,000 |
Finite-lived intangible asset, Net | 175,000 | 429,000 |
Polymed Technology | ||
Schedule Of Finite And Indefinite Lived Intangible Assets [Line Items] | ||
Finite-lived intangible asset, Cost/Fair Value | 3,712,000 | 3,712,000 |
Finite-lived intangible asset, Accumulated Amortization | 1,685,000 | 1,297,000 |
Finite-lived intangible asset, Net | $ 2,027,000 | 2,415,000 |
Product Rights | ||
Schedule Of Finite And Indefinite Lived Intangible Assets [Line Items] | ||
Finite-lived intangible asset, Cost/Fair Value | 530,000 | |
Finite-lived intangible asset, Accumulated Amortization | 360,000 | |
Finite-lived intangible asset, Impairments | $ 170,000 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets, Net - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Finite Lived Intangible Assets [Line Items] | |||
Impairments of intangible assets | $ 170,000 | ||
Weighted-average useful life of intangible assets | 7 years 1 month 6 days | ||
Amortization expense of intangible assets | $ 1,800,000 | 1,900,000 | $ 1,600,000 |
Research and Development Expenses | |||
Finite Lived Intangible Assets [Line Items] | |||
Impairments of intangible assets | $ 200,000 | $ 300,000 | |
CDE In- Process Research and Development | |||
Finite Lived Intangible Assets [Line Items] | |||
Impairments of intangible assets | 0 | ||
Licensing Agreements | Hanmi Pharmaceuticals Co. Ltd. | |||
Finite Lived Intangible Assets [Line Items] | |||
Finite-lived intangible assets acquired | $ 400,000 | ||
Acquired finite-lived intangible assets, amortization period | 12 years 9 months | ||
Licensing Agreements | Gland Pharma Ltd | |||
Finite Lived Intangible Assets [Line Items] | |||
Finite-lived intangible assets acquired | $ 4,400,000 | ||
Acquired finite-lived intangible assets, amortization period | 5 years | ||
Licensing Agreements | MAIA Pharmaceuticals, Inc | |||
Finite Lived Intangible Assets [Line Items] | |||
Finite-lived intangible assets acquired | $ 4,000,000 | ||
Acquired finite-lived intangible assets, amortization period | 7 years | ||
Licensing Agreements | Ingenus Pharmaceuticals, LLC | |||
Finite Lived Intangible Assets [Line Items] | |||
Finite-lived intangible assets acquired | $ 2,000,000 | ||
Acquired finite-lived intangible assets, amortization period | 5 years | ||
Licenses of Other Specialty Products | Ingenus Pharmaceuticals, LLC | |||
Finite Lived Intangible Assets [Line Items] | |||
Finite-lived intangible assets acquired | $ 700,000 | ||
Customer List | Polymed | |||
Finite Lived Intangible Assets [Line Items] | |||
Acquired finite-lived intangible assets, amortization period | 6 years | ||
Polymed Technology | Polymed | |||
Finite Lived Intangible Assets [Line Items] | |||
Acquired finite-lived intangible assets, amortization period | 12 years |
Goodwill and Intangible Asset_6
Goodwill and Intangible Assets, Net - Schedule of Expected Amortization Expense of Finite-Lived Intangible Assets (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Finite Lived Intangible Assets Future Amortization Expense [Abstract] | |
2021 | $ 2,653 |
2022 | 1,834 |
2023 | 1,805 |
2024 | 1,430 |
2025 | 1,388 |
Thereafter | 576 |
Finite-lived intangible asset, Net | $ 9,686 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Fair value assets, Level 1 to Level 2 transfers | $ 0 | $ 0 | $ 0 |
Fair value assets, Level 2 to Level 1 transfers | 0 | 0 | 0 |
Fair value liabilities, Level 1 to Level 2 transfers | 0 | 0 | 0 |
Fair value liabilities, Level 2 to Level 1 transfers | 0 | 0 | 0 |
Fair value assets, transfers out of Level 3 | 0 | 0 | 0 |
Fair value liabilities, transfers into Level 3 | 0 | 0 | 0 |
Fair value liabilities, transfers out of Level 3 | $ 0 | $ 0 | $ 0 |
Pharma Essentia | OTC | Taiwan | Quoted Prices in Active Markets for Identical Assets (Level 1) | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Number of shares owned by company | 68,000 | 68,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Total assets | $ 188,181 | $ 104,726 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total assets | 5,842 | 5,710 |
Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total assets | 182,339 | 99,016 |
Money Market Funds | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 5,615 | 5,460 |
Money Market Funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 5,615 | 5,460 |
Short-term Investments - Certificates of Deposits | Short-term Investments | ||
Assets: | ||
Total assets | 20,696 | 10,054 |
Short-term Investments - Certificates of Deposits | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 4,070 | 15,110 |
Short-term Investments - Certificates of Deposits | Significant Other Observable Inputs (Level 2) | Short-term Investments | ||
Assets: | ||
Total assets | 20,696 | 10,054 |
Short-term Investments - Certificates of Deposits | Significant Other Observable Inputs (Level 2) | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 4,070 | 15,110 |
Short-term Investments - Commercial Paper | Short-term Investments | ||
Assets: | ||
Total assets | 102,715 | 22,835 |
Short-term Investments - Commercial Paper | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 34,860 | 51,017 |
Short-term Investments - Commercial Paper | Significant Other Observable Inputs (Level 2) | Short-term Investments | ||
Assets: | ||
Total assets | 102,715 | 22,835 |
Short-term Investments - Commercial Paper | Significant Other Observable Inputs (Level 2) | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 34,860 | 51,017 |
U.S. Government Bonds | Short-term Investments | ||
Assets: | ||
Total assets | 14,998 | |
U.S. Government Bonds | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 5,000 | |
U.S. Government Bonds | Significant Other Observable Inputs (Level 2) | Short-term Investments | ||
Assets: | ||
Total assets | 14,998 | |
U.S. Government Bonds | Significant Other Observable Inputs (Level 2) | Cash and Cash Equivalents | ||
Assets: | ||
Total assets | 5,000 | |
Available-for-Sale Investment | Short-term Investments | ||
Assets: | ||
Total assets | 227 | 250 |
Available-for-Sale Investment | Quoted Prices in Active Markets for Identical Assets (Level 1) | Short-term Investments | ||
Assets: | ||
Total assets | $ 227 | $ 250 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 29, 2018 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Acquisition [Line Items] | ||||||||||||
Research and development licensing fee satisfied with stock | $ 31,545 | |||||||||||
Research and development expenses | $ 18,307 | $ 18,390 | $ 22,015 | $ 17,192 | $ 21,823 | $ 19,588 | $ 18,507 | $ 24,475 | $ 75,904 | $ 84,393 | 119,905 | |
Axis Therapeutics Limited | ||||||||||||
Acquisition [Line Items] | ||||||||||||
Capital contributions to joint venture | $ 30,000 | 30,000 | $ 30,000 | |||||||||
Percentage of ownership in joint venture | 55.00% | 55.00% | ||||||||||
Axis Therapeutics Limited | Research and Development Expenses | ||||||||||||
Acquisition [Line Items] | ||||||||||||
Research and development expenses | $ 24,500 | |||||||||||
Sponsor investigation charges | $ 4,000 | $ 1,200 | ||||||||||
Axis Therapeutics Limited | Licensing Agreements | ||||||||||||
Acquisition [Line Items] | ||||||||||||
Research and development licensing fee satisfied with stock, shares | 267,952 | |||||||||||
Research and development licensing fee satisfied with stock | $ 5,000 | |||||||||||
Axis Therapeutics Limited | XLifeSc | IPR & D | ||||||||||||
Acquisition [Line Items] | ||||||||||||
Percentage of ownership in joint venture | 45.00% | |||||||||||
Percentage of nonmonetary exchange of shares | 45.00% | |||||||||||
Fair value of equity shares issued | $ 24,500 | $ 24,500 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expensest (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities Current [Abstract] | ||
Accrued selling fees, rebates, and royalties | $ 9,046 | $ 1,577 |
Accrued wages and benefits | 6,720 | 7,541 |
Accrued construction costs | 4,104 | 22,811 |
Accrued inventory purchases | 3,714 | 7,194 |
Accrued interest | 3,583 | |
Accrued operating expenses | 3,222 | 1,885 |
Accrued clinical expenses | 2,949 | 2,510 |
Accrued tax withholdings | 1,948 | 187 |
Accrued costs for product launch | 1,474 | |
Deferred revenue | 1,147 | 218 |
Accrued R&D licensing fees | 366 | 384 |
Total accrued expenses | $ 38,273 | $ 44,307 |
Accrued Expenses - Additional I
Accrued Expenses - Additional Information (Detail) - Dunkirk - Manufacturing Facility $ in Millions | Dec. 31, 2020USD ($) |
Accrued Liabilities [Line Items] | |
Accrued construction cost expected to be funded additional amount paid | $ 0.5 |
Prepaid Expenses and Other Current Assets | |
Accrued Liabilities [Line Items] | |
Accrued construction costs expected to be funded | $ 4.6 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | Mar. 27, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax [Line Items] | ||||
Income tax expense | $ 4,088,000 | $ 928,000 | $ 100,000 | |
Federal net operating losses | 448,500,000 | |||
State net operating losses | 88,200,000 | |||
Foreign net operating losses | 34,200,000 | |||
Increase in valuation allowance for deferred tax assets | 29,677,000 | 32,342,000 | 28,034,000 | |
Uncertain tax positions | 0 | 0 | 0 | |
Amounts recognized for interest and penalties related to unrecognized tax benefits | $ 0 | $ 0 | $ 0 | |
CARES ACT | ||||
Income Tax [Line Items] | ||||
Net operating loss carryback period | 5 years | |||
Operating loss carryforwards, limitations on use description | On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) into law. The CARES Act includes several significant business tax provisions that, among other things, would eliminate the taxable income limit for certain net operating losses (“NOLs”) and allow businesses to carry back NOLs arising in 2018, 2019, and 2020 to the five prior tax years, accelerate refunds of previously generated corporate alternative minimum tax credits, change the business interest limitation under Internal Revenue Code (“IRC”) section 163(j) of the IRC from 30 percent to 50 percent, and fix qualified improvement property from the Tax Cuts and Jobs Act of 2017. | |||
Minimum [Member] | CARES ACT | ||||
Income Tax [Line Items] | ||||
Percentage of change in business interest limitation | 30.00% | |||
Maximum | CARES ACT | ||||
Income Tax [Line Items] | ||||
Percentage of change in business interest limitation | 50.00% | |||
Federal | ||||
Income Tax [Line Items] | ||||
Federal net operating losses, subject to expiration | $ 184,800,000 | |||
Federal net operating losses, beginning expiration period | 2027 | |||
Federal net operating losses, not subject to expiration | $ 263,700,000 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Tax Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Noncontrolling Interest [Abstract] | |||
Domestic | $ (133,929) | $ (109,769) | $ (95,479) |
Foreign | (10,417) | (14,836) | (33,132) |
Loss before income tax expense | $ (144,346) | $ (124,605) | $ (128,611) |
Income Taxes - Components of th
Income Taxes - Components of the Income Tax Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Current: | |||
State | $ 4 | $ 23 | $ 27 |
Foreign | 4,026 | 419 | 455 |
Total | 4,030 | 442 | 482 |
Deferred: | |||
Federal | (27,279) | (26,878) | (26,260) |
State | (916) | (2,567) | (293) |
Foreign | (1,424) | (2,411) | (1,863) |
Total | (29,619) | (31,856) | (28,416) |
Change in valuation allowance | 29,677 | 32,342 | 28,034 |
Total | $ 4,088 | $ 928 | $ 100 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Expense Differs From the Federal Statutory Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Reconciliation, Other Reconciling Items, Percent [Abstract] | |||
Statutory rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | 0.70% | 2.00% | 0.20% |
Foreign rate differential | 0.10% | 0.10% | (0.30%) |
Valuation allowance | (20.30%) | (25.90%) | (21.60%) |
Stock-based compensation | (2.60%) | ||
Foreign tax withholdings | (2.30%) | (0.20%) | |
Other | 0.60% | 1.90% | 0.60% |
Effective rate | (2.80%) | (0.70%) | (0.10%) |
Income Taxes - Schedule of Net
Income Taxes - Schedule of Net Deferred Income Tax Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Components of Deferred Tax Assets and Liabilities [Abstract] | ||
Intangible assets | $ 11,372 | $ 11,348 |
Property and equipment | 51 | 77 |
Stock-based compensation | 7,148 | 9,551 |
Net operating loss carryforwards | 106,342 | 81,630 |
Tax credit carryforwards | 13,528 | 9,191 |
Research and development deduction | 1,859 | 1,493 |
Reserves and accruals | 11,472 | 8,377 |
Gross deferred income tax assets | 151,772 | 121,667 |
Less: valuation allowance | (150,864) | (120,805) |
Net deferred income tax assets | 908 | 862 |
Intangible assets | (821) | (862) |
Property and equipment | (143) | |
Gross deferred income tax liabilities | (964) | $ (862) |
Net deferred income tax liabilities | $ (56) |
Debt and Lease Obligations - Su
Debt and Lease Obligations - Summary of Balances of Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Current portion of mortgage | $ 731 | $ 686 |
Current portion of bank loan | 764 | |
Current portion of senior secured loan | 70 | |
Current portion of finance lease obligations | 445 | 194 |
Current portion of operating lease obligations | 3,185 | 3,010 |
Long-term portion of finance lease obligations | 537 | 227 |
Long-term portion of operating lease obligations | 6,355 | 7,620 |
Total | 158,127 | 63,876 |
Chongqing Maliu Credit Agreement | ||
Debt Instrument [Line Items] | ||
Chongqing Maliu credit agreement | 7,641 | 5,731 |
Senior Secured Loan | ||
Debt Instrument [Line Items] | ||
Senior secured loan, net of debt discount and financing fees of $11,601 and $3,592, respectively | $ 138,399 | $ 46,408 |
Debt and Lease Obligations - _2
Debt and Lease Obligations - Summary of Balances of Debt (Parenthetical) (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Senior Secured Loan | ||
Debt Instrument [Line Items] | ||
Debt discount and financing fees | $ 11,601 | $ 3,592 |
Debt and Lease Obligations - Ad
Debt and Lease Obligations - Additional Information (Detail) $ / shares in Units, ¥ in Millions | Sep. 17, 2020 | Aug. 04, 2020USD ($)$ / sharesshares | Jun. 19, 2020USD ($)Tranche | May 15, 2020USD ($) | Jan. 01, 2020 | Jan. 01, 2019 | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Aug. 04, 2026USD ($) | Sep. 30, 2024USD ($) | May 15, 2020CNY (¥) | Jun. 30, 2019CNY (¥) |
Debt Instrument [Line Items] | |||||||||||||||||||||
Loss on extinguishment of debt | $ 10,278,000 | ||||||||||||||||||||
Revenues | $ 21,808,000 | $ 35,476,000 | $ 40,172,000 | $ 46,935,000 | $ 34,361,000 | $ 19,364,000 | $ 22,197,000 | $ 25,307,000 | $ 144,391,000 | $ 101,229,000 | $ 89,100,000 | ||||||||||
Mortgage payment extended date | Dec. 31, 2021 | ||||||||||||||||||||
Accounting Standards Update Extensible List | us-gaap:AccountingStandardsUpdate201613Member | us-gaap:AccountingStandardsUpdate201613Member | |||||||||||||||||||
Accounting standards adopted | true | true | |||||||||||||||||||
Accounting standards adoption date | Jan. 1, 2020 | Jan. 1, 2020 | |||||||||||||||||||
ASU No. 2016-02 | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Accounting Standards Update Extensible List | us-gaap:AccountingStandardsUpdate201602Member | ||||||||||||||||||||
Accounting standards adopted | true | ||||||||||||||||||||
Accounting standards adoption date | Jan. 1, 2019 | ||||||||||||||||||||
Chongqing Maliu Riverside Development and Investment Co., LTD ("CQ") | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Line of credit facility percentage of periodic payment year one | 20.00% | ||||||||||||||||||||
Line of credit facility percentage of periodic payment year two | 30.00% | ||||||||||||||||||||
Line of credit frequency of payments | The Company is required to repay the principal amount with accrued interest within three years after the plant receives the cGMP certification, with 20% of the total loan with accrued interest is due within the first twelve months following receiving the certification, 30% of the total loan with accrued interest due within twenty-four months, and the remaining balance with accrued interest due within thirty-six months. | ||||||||||||||||||||
Line of credit due | $ 7,641,000 | $ 5,731,000 | $ 7,641,000 | 5,731,000 | |||||||||||||||||
China | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Revenues | 39,796,000 | $ 2,105,000 | $ 4,416,000 | ||||||||||||||||||
China | Chongqing Maliu Riverside Development and Investment Co., LTD ("CQ") | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Debt instrument, maximum borrowing capacity | 7,700,000 | $ 7,700,000 | ¥ 50 | ||||||||||||||||||
Long-term line of credit, interest rate | 4.75% | ||||||||||||||||||||
Sagard and IMCO Investors | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Warrants to purchase common stock outstanding | shares | 201,865 | ||||||||||||||||||||
Purchase price | $ / shares | $ 12.63 | ||||||||||||||||||||
Senior Credit Agreement | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Debt maturity date | Jun. 19, 2026 | Jun. 19, 2026 | |||||||||||||||||||
Loss on extinguishment of debt | $ 7,200,000 | ||||||||||||||||||||
Number of tranches | Tranche | 5 | ||||||||||||||||||||
Debt instrument, maximum borrowing capacity | $ 225,000,000 | ||||||||||||||||||||
Available borrowing capacity upon satisfaction of regulatory and commercial milestones | $ 75,000,000 | ||||||||||||||||||||
Interest rate terms | The loan bears interest at a fixed annual rate of 11.0%. The Company is required to make quarterly interest-only payments until June 19, 2022, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity | ||||||||||||||||||||
Bearing interest at a fixed annual rate | 11.00% | ||||||||||||||||||||
Frequency of payment | quarterly | ||||||||||||||||||||
Commitment fee percentage will be paid | 0.60% | ||||||||||||||||||||
Exit fee liability | 2,000,000 | $ 2,000,000 | |||||||||||||||||||
Minimum liquidity amount in cash or permitted cash equivalent investments amount | $ 20,000 | ||||||||||||||||||||
Line of credit from first step up date until maturity | 25,000 | ||||||||||||||||||||
Line of credit facility second step up date outstanding amount | 225,000 | ||||||||||||||||||||
Line of credit from second step up date until maturity | $ 30,000 | ||||||||||||||||||||
Minimum revenue percentage | 50 | ||||||||||||||||||||
Senior Credit Agreement | Sagard and IMCO Investors | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Principal value of loan | $ 50,000,000 | ||||||||||||||||||||
Senior Credit Agreement | Minimum [Member] | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Line of credit facility first step up date outstanding amount | $ 150,000 | ||||||||||||||||||||
Senior Credit Agreement | Maximum | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Covenant leverage ratio | 4.50 | ||||||||||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Licenses revenue | $ 50,000,000 | ||||||||||||||||||||
Payment percentage of world-wide net sales | 5.00% | ||||||||||||||||||||
Percentage of product payment | 170.00% | ||||||||||||||||||||
Payments due to related parties | $ 85,000,000 | ||||||||||||||||||||
Percentage of internal rate of return | 6.00% | ||||||||||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | Scenario Forecast | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Payments due to related parties | $ 50,000,000 | $ 20,000,000 | |||||||||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | Payments at Repurchase Price On or Before August 4, 2023 | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Percentage of internal rate of return of product payment | 18.00% | ||||||||||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | Payments at Repurchase Price After August 4, 2023 and On or Before August 4, 2024 | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Percentage of internal rate of return of product payment | 16.00% | ||||||||||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | Payments at Repurchase Price After August 4, 2024 and On or Before August 4, 2025 | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Percentage of internal rate of return of product payment | 15.00% | ||||||||||||||||||||
Revenue Interest Financing Agreement | Sagard Healthcare Royalty Partners, LP | Payments at Repurchase Price, Thereafter | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Percentage of expected internal rate of return of product payment | 13.00% | ||||||||||||||||||||
Percentage of product payment and repurchase price | 165.00% | ||||||||||||||||||||
Revenue Interest Financing Agreement | Maximum | Sagard Healthcare Royalty Partners, LP | Oncology Innovation Platform | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Revenues | $ 500,000,000 | ||||||||||||||||||||
Credit Agreement | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Debt maturity date | May 14, 2021 | ||||||||||||||||||||
Debt instrument, maximum borrowing capacity | $ 800,000 | ||||||||||||||||||||
Bearing interest at a fixed annual rate | 4.35% | 4.35% | |||||||||||||||||||
Debt instrument, amount drawn | 800,000 | ||||||||||||||||||||
Credit Agreement | China | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Debt instrument, maximum borrowing capacity | ¥ | ¥ 5 | ||||||||||||||||||||
Tranche A,B and C | Senior Credit Agreement | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Debt instrument, amount drawn | 150,000,000 | 150,000,000 | |||||||||||||||||||
Tranche D 90 Days After Closing Date Through June 20, 2022 | Senior Credit Agreement | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Available borrowing capacity upon satisfaction of regulatory and commercial milestones | $ 25,000,000 | ||||||||||||||||||||
Tranche E 90 Days After Closing Date Through June 19, 2023 | Senior Credit Agreement | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Available borrowing capacity upon satisfaction of regulatory and commercial milestones | 50,000,000 | ||||||||||||||||||||
Senior Secured Loan | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Principal value of loan | $ 50,000,000 | $ 50,000,000 | |||||||||||||||||||
Debt maturity date | Jun. 30, 2023 | ||||||||||||||||||||
Prepayment fee | 3,800,000 | ||||||||||||||||||||
Unamortized debt discount | 3,100,000 | ||||||||||||||||||||
Other charges | 300,000 | ||||||||||||||||||||
Loss on extinguishment of debt | $ 7,200,000 | ||||||||||||||||||||
Senior Secured Loan | LIBOR | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Debt variable rate basis floor | 2.00% | ||||||||||||||||||||
Basis spread on variable rate | 9.00% | ||||||||||||||||||||
Senior Loan | Sagard and IMCO Investors | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Loss on extinguishment of debt | $ 3,000,000 | ||||||||||||||||||||
Unsecured, Subordinated Bank Loan from China Merchants Bank | China | |||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||
Principal value of loan | $ 700,000 | ||||||||||||||||||||
Debt maturity date | Dec. 11, 2019 | ||||||||||||||||||||
Interest rate | 5.70% |
Debt and Lease Obligations - _3
Debt and Lease Obligations - Summary of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Debt And Lease Obligations [Abstract] | ||
Operating lease cost | $ 3,041 | $ 3,162 |
Finance lease cost: | ||
Amortization of assets | 238 | 81 |
Interest on lease liabilities | 73 | 31 |
Total net lease cost | $ 3,352 | $ 3,274 |
Debt and Lease Obligations - Sc
Debt and Lease Obligations - Schedule of Supplemental Balance Sheet Information Related to Leases of Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Finance leases: | ||
Property and equipment, at cost | $ 1,535 | $ 688 |
Accumulated amortization, net | (347) | (109) |
Property and equipment, net | $ 1,188 | $ 579 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:PropertyPlantAndEquipmentNet | us-gaap:PropertyPlantAndEquipmentNet |
Current obligations of finance leases | $ 445 | $ 194 |
Long-term portion of finance leases | 537 | 227 |
Total finance lease obligations | $ 982 | $ 421 |
Weighted average remaining lease term (in years): | ||
Operating leases | 4 years 2 months 23 days | 5 years 2 months 15 days |
Finance leases | 3 years 4 months 24 days | 2 years 1 month 9 days |
Weighted average discount rate: | ||
Operating leases | 12.80% | 12.90% |
Finance leases | 10.40% | 5.90% |
Debt and Lease Obligations - _4
Debt and Lease Obligations - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Cash paid for amount included in the measurements of lease liabilities: | |
Operating cash flows from operating leases | $ (3,304) |
Operating cash flows from finance leases | (286) |
Financing cash flows from finance leases | (73) |
ROU assets recognized in exchange for new operating lease obligations | $ 852 |
Debt and Lease Obligations - _5
Debt and Lease Obligations - Schedule of Future Minimum Payments and Maturities of Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Operating Leases | ||
2021 | $ 3,454 | |
2022 | 2,927 | |
2023 | 2,096 | |
2024 | 2,002 | |
2025 | 1,472 | |
Thereafter | 478 | |
Total lease payments | 12,429 | |
Less: Imputed interest | (2,889) | |
Total lease obligations | 9,540 | |
Less: Current obligations | (3,185) | $ (3,010) |
Long-term lease obligations | 6,355 | 7,620 |
Finance Leases | ||
2021 | 468 | |
2022 | 275 | |
2023 | 248 | |
2024 | 177 | |
Total lease payments | 1,168 | |
Less: Imputed interest | (186) | |
Total finance lease obligations | 982 | 421 |
Less: Current obligations | (445) | (194) |
Long-term portion of finance lease obligations | $ 537 | $ 227 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Dec. 31, 2020USD ($)AgreementExecutiveshares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($) | |
Nuwagen Limited | ||||
Related Party Transaction [Line Items] | ||||
Percentage of ownership interest of newly formed entity | 10.00% | |||
Avalon BioMedical | ||||
Related Party Transaction [Line Items] | ||||
Common stock shares held by related parties | shares | 786,061 | 786,061 | ||
Percentage of common stock issued shares | 1.00% | 1.00% | ||
Avalon BioMedical | Nuwagen Limited | ||||
Related Party Transaction [Line Items] | ||||
Percentage of ownership interest | 90.00% | |||
Avalon BioMedical | In-licensing Agreement | ||||
Related Party Transaction [Line Items] | ||||
Number of in-licensing agreements | Agreement | 2 | |||
Avalon BioMedical | In-licensing Agreement | Research and Development Expenses | ||||
Related Party Transaction [Line Items] | ||||
Milestone fee paid | $ 0 | $ 1,000,000 | ||
Pharma Essentia | ||||
Related Party Transaction [Line Items] | ||||
Licenses revenue | 2,000,000 | 0 | $ 2,300,000 | |
Funds paid to related party | $ 400,000 | 400,000 | ||
Executive Officer | ||||
Related Party Transaction [Line Items] | ||||
Number of executives | Executive | 1 | |||
ZenRx | ||||
Related Party Transaction [Line Items] | ||||
Licenses revenue | $ 0 | 0 | 0 | |
ZenRx | Clinical Development Services | ||||
Related Party Transaction [Line Items] | ||||
Payments to related party for services received | $ 600,000 | $ 2,700,000 | $ 300,000 |
Business and Economic Collabo_2
Business and Economic Collaborative Agreements - Additional Information (Detail) | Jan. 05, 2021m²¥ / SquareMeter | Sep. 04, 2017USD ($)ft² | May 01, 2015USD ($) | Oct. 31, 2015USD ($)ft²¥ / SquareMeter | Dec. 31, 2020USD ($)¥ / SquareMeter |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Lease term | 10 years | ||||
Renewal lease term | 10 years | ||||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 | ||||
Chinese Subsidiaries | API Facility | Chongqing International Biological City Development & Investment Co., Ltd | Subsequent Event | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Lease term | 10 years | ||||
Renewal lease term | 10 years | ||||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 | ||||
Area of rent free lease | m² | 34,517 | ||||
GMP API Manufacturing Plant | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Minimum capital requirement | $ 30,000,000 | ||||
Contributed registration capital to subsidiary set up | $ 14,100,000 | ||||
Grant Disbursement Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Area of building to be built under agreement | ft² | 320,000 | ||||
Area of building space built under agreement | ft² | 409,000 | ||||
Purchase rate of equipment per year in first 10 year term | $ 1 | 1 | |||
Purchase rate of equipment per year in second 10 year term | 1 | 1 | |||
Operating expenses committed to spent in first 10 year term | 1,520,000,000 | 1,520,000,000 | |||
Operating expenses committed to spent in second 10 year term | $ 1,500,000,000 | $ 1,500,000,000 | |||
Lease term | 10 years | 10 years | |||
Renewal lease term | 10 years | 10 years | |||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 | ||||
New York State | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Proceeds from state | $ 25,000,000 | ||||
Sublease term | 10 years | ||||
Sublease, option to extend | with an option to extend the term for an additional 10 years. | ||||
Sublease, option to extend term | 10 years | ||||
Finance sublease, existence of option to extend [true false] | true | ||||
New York State | Grant Disbursement Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Proceeds from state | $ 8,000,000 | ||||
New York State | Grant Disbursement Agreement | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Proceeds from state | $ 208,000,000 | ||||
China | GMP API Manufacturing Plant | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Area of building to be built under agreement | ft² | 440,000 | ||||
China | GMP Pharmaceutical Manufacturing Plant | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Area of building to be built under agreement | ft² | 510,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | May 23, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 14, 2017 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 10,850 | $ 9,885 | $ 11,011 | ||
Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | 9,557 | 7,887 | 9,786 | ||
Unrecognized compensation cost related to non-vested stock options expected to be recognized | $ 18,700 | ||||
Unrecognized compensation expense related to non-vested stock options, weighted-average period of recognition | 1 year 10 months 24 days | ||||
Total intrinsic value of stock options exercised | $ 1,500 | 2,700 | |||
Stock options granted, contractual term | 10 years | ||||
Restricted Stock Awards | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 1,017 | $ 566 | 1,008 | ||
Unrecognized compensation expense related to non-vested stock options, weighted-average period of recognition | 1 year 2 months 12 days | ||||
Shares granted to employees | 0 | 131,000 | |||
Unrecognized cost related to non-vested restricted stock awards | $ 300 | ||||
Maximum | Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock options granted, vesting period | 4 years | ||||
Maximum | Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for future issuance | 1,000,000 | ||||
Minimum [Member] | Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock options granted, vesting period | 2 years | ||||
2017, 2013, 2007 and 2004 Plans | Maximum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock options authorized grant | 16,000,000 | ||||
2017 Omnibus Incentive Plan | Maximum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Increase in stock available for issuance under plan | 500,000 | ||||
2017 Plans | Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for future issuance | 1,000,000 | ||||
Stock-based compensation expense | $ 300 | $ 300 | $ 200 | ||
Percentage of discount on purchase price of common stock | 15.00% | ||||
Employee stock purchase plan, description | Under the ESPP, shares of the Company’s common stock may be purchased at a discount (15%) of the lesser of the closing price of the Company’s common stock on the first trading or the last trading day of the offering period. The current offering period extends from December 1, 2020 to May 31, 2021. The Company expects to offer six-month offering periods after the current period. | ||||
Shares of common stock issued | 50,827 | 60,825 | 41,733 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Options | ||
Stock Options, Outstanding Beginning Balance | 10,916,936 | |
Stock Options, Granted | 1,970,972 | |
Stock Options, Exercised | (238,630) | |
Stock Options, Forfeited and expired | (152,390) | |
Stock Options, Outstanding Ending Balance | 12,496,888 | 10,916,936 |
Stock Options, Vested and exercisable | 9,126,142 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Outstanding Beginning Balance | $ 8.88 | |
Weighted Average Exercise Price, Granted | 11.46 | |
Weighted Average Exercise Price, Exercised | 7.23 | |
Weighted Average Exercise Price, Forfeited and expired | 13.31 | |
Weighted Average Exercise Price, Outstanding Ending Balance | 9.26 | $ 8.88 |
Weighted Average Exercise Price, Vested and exercisable | $ 7.89 | |
Weighted Average Remaining Contractual Term | ||
Weighted Average Remaining Contractual Term, Outstanding | 5 years 5 months 1 day | 6 years 10 months 13 days |
Weighted Average Remaining Contractual Term, Vested and exercisable | 4 years 3 months 14 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Outstanding | $ 22,463 | $ 69,785 |
Aggregate Intrinsic Value, Vested and exercisable | $ 28,936 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Weighted-Average Assumptions Used as Inputs to Black-Scholes Option Pricing Model (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Weighted average grant date fair value | $ 6.93 | $ 8.06 | $ 9.80 |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected stock price volatility | 67.00% | 64.00% | 59.00% |
Risk-free interest rate | 0.91% | 2.60% | 2.61% |
Expected life of options (in years) | 6 years 2 months 12 days | 6 years 3 months 18 days | 6 years 1 month 6 days |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Stock-Based Compensation Cost (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | $ 10,850 | $ 9,885 | $ 11,011 |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | 9,557 | 7,887 | 9,786 |
Restricted Stock Expense | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | 1,017 | 566 | 1,008 |
Stock Awarded to Directors and Officers | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | 1,105 | ||
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | 276 | 327 | 217 |
Cost of Sales | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | 249 | 248 | 228 |
Research and Development Expenses | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | 3,647 | 3,251 | 2,621 |
Selling, General, and Administrative Expenses | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock-based compensation expense recognized | $ 6,954 | $ 6,386 | $ 8,162 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Athenex, Inc. Common Stockholders - Schedule Weighted Average Outstanding Shares of Common Stock Equivalents Excluded from the Calculation of Diluted Net Loss Per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Total potential dilutive common shares | 12,825,632 | 10,860,216 | 10,593,344 |
Stock Options and Other Common Stock Equivalents | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Total potential dilutive common shares | 12,748,882 | 10,814,635 | 10,480,084 |
Unvested Restricted Common Shares | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Total potential dilutive common shares | 76,750 | 45,581 | 113,260 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Loss - Schedule of Accumulated Other Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Beginning balance | $ 175,855 | $ 128,769 | $ 90,722 |
Unrealized gain (loss) on investment | (5) | (97) | 15 |
Ending balance | 165,348 | 175,855 | 128,769 |
Accumulated Other Comprehensive Loss | |||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Beginning balance | (635) | (656) | (146) |
Foreign currency translation adjustment | (494) | 118 | (525) |
Unrealized gain (loss) on investment | (5) | (97) | 15 |
Ending balance | $ (1,134) | $ (635) | $ (656) |
Business Segment, Geographic,_3
Business Segment, Geographic, and Concentration Risk Information - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2020Segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 3 |
Business Segment, Geographic,_4
Business Segment, Geographic, and Concentration Risk Information - Summary of Revenue by Segments (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total revenue: | |||||||||||
Total consolidated revenue | $ 21,808 | $ 35,476 | $ 40,172 | $ 46,935 | $ 34,361 | $ 19,364 | $ 22,197 | $ 25,307 | $ 144,391 | $ 101,229 | $ 89,100 |
Operating Segments | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 148,914 | 104,959 | 94,476 | ||||||||
Operating Segments | Oncology Innovation Platform | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 38,851 | 20,562 | 32,776 | ||||||||
Operating Segments | Global Supply Chain Platform | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 20,491 | 33,970 | 31,274 | ||||||||
Operating Segments | Commercial Platform | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 89,572 | 50,427 | 30,426 | ||||||||
Intersegment Eliminations | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | $ (4,523) | $ (3,730) | $ (5,376) |
Business Segment, Geographic,_5
Business Segment, Geographic, and Concentration Risk Information - Summary of Revenue by Product Group (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total revenue by product group: | |||||||||||
Total consolidated revenue | $ 21,808 | $ 35,476 | $ 40,172 | $ 46,935 | $ 34,361 | $ 19,364 | $ 22,197 | $ 25,307 | $ 144,391 | $ 101,229 | $ 89,100 |
Commercial Product Sales | |||||||||||
Total revenue by product group: | |||||||||||
Total consolidated revenue | 101,590 | 67,411 | 35,640 | ||||||||
License Fees | |||||||||||
Total revenue by product group: | |||||||||||
Total consolidated revenue | 38,827 | 20,100 | 32,000 | ||||||||
API Sales | |||||||||||
Total revenue by product group: | |||||||||||
Total consolidated revenue | 3,599 | 12,733 | 17,952 | ||||||||
Contract Manufacturing Revenue | |||||||||||
Total revenue by product group: | |||||||||||
Total consolidated revenue | 85 | 391 | 458 | ||||||||
Medical Device Sales | |||||||||||
Total revenue by product group: | |||||||||||
Total consolidated revenue | 2,344 | ||||||||||
Other Revenue | |||||||||||
Total revenue by product group: | |||||||||||
Total consolidated revenue | $ 290 | $ 594 | $ 706 |
Business Segment, Geographic,_6
Business Segment, Geographic, and Concentration Risk Information - Summary of Segment Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Net loss attributable to Athenex, Inc.: | |||||||||||
Total consolidated net loss attributable to Athenex, Inc. | $ (49,493) | $ (36,806) | $ (40,451) | $ (19,429) | $ (21,727) | $ (34,758) | $ (32,031) | $ (35,233) | $ (146,179) | $ (123,749) | $ (117,440) |
Oncology Innovation Platform | |||||||||||
Net loss attributable to Athenex, Inc.: | |||||||||||
Total consolidated net loss attributable to Athenex, Inc. | (89,189) | (100,919) | (89,912) | ||||||||
Global Supply Chain Platform | |||||||||||
Net loss attributable to Athenex, Inc.: | |||||||||||
Total consolidated net loss attributable to Athenex, Inc. | (19,400) | (8,575) | (16,858) | ||||||||
Commercial Platform | |||||||||||
Net loss attributable to Athenex, Inc.: | |||||||||||
Total consolidated net loss attributable to Athenex, Inc. | $ (37,590) | $ (14,255) | $ (10,670) |
Business Segment, Geographic,_7
Business Segment, Geographic, and Concentration Risk Information - Summary of Depreciation, Amortization and Assets by Segment (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total depreciation and amortization | |||
Total consolidated depreciation and amortization | $ 4,492 | $ 3,817 | $ 3,269 |
Total assets: | |||
Total assets | 384,329 | 309,932 | |
Oncology Innovation Platform | |||
Total depreciation and amortization | |||
Total consolidated depreciation and amortization | 776 | 762 | 690 |
Total assets: | |||
Total assets | 234,153 | 194,183 | |
Global Supply Chain Platform | |||
Total depreciation and amortization | |||
Total consolidated depreciation and amortization | 2,048 | 1,489 | 1,603 |
Total assets: | |||
Total assets | 99,087 | 63,598 | |
Commercial Platform | |||
Total depreciation and amortization | |||
Total consolidated depreciation and amortization | 1,668 | 1,566 | $ 976 |
Total assets: | |||
Total assets | $ 51,089 | $ 52,151 |
Business Segment, Geographic,_8
Business Segment, Geographic, and Concentration Risk Information - Summary of Revenue by Geographical Segment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total revenue: | |||||||||||
Total consolidated revenue | $ 21,808 | $ 35,476 | $ 40,172 | $ 46,935 | $ 34,361 | $ 19,364 | $ 22,197 | $ 25,307 | $ 144,391 | $ 101,229 | $ 89,100 |
United States | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 82,362 | 67,794 | 37,904 | ||||||||
China | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 39,796 | 2,105 | 4,416 | ||||||||
United Kingdom | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 19,289 | 1,023 | |||||||||
South Korea | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 2,354 | 513 | |||||||||
Austria | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 226 | 4,422 | 9,569 | ||||||||
India | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 3,066 | 3,457 | |||||||||
Spain | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | 20,000 | 30,000 | |||||||||
Other Foreign Countries | |||||||||||
Total revenue: | |||||||||||
Total consolidated revenue | $ 364 | $ 2,306 | $ 3,754 |
Business Segment, Geographic,_9
Business Segment, Geographic, and Concentration Risk Information - Summary of Property and Equipment by Geographical Segment (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Total property and equipment, net: | ||
Total property and equipment, net | $ 34,388 | $ 23,153 |
United States | ||
Total property and equipment, net: | ||
Total property and equipment, net | 15,511 | 11,486 |
China | ||
Total property and equipment, net: | ||
Total property and equipment, net | $ 18,877 | $ 11,667 |
Business Segment, Geographic_10
Business Segment, Geographic, and Concentration Risk Information - Summary of Customer Revenue and Accounts Receivable Concentration (Detail) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Customer Revenue | Customer A | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 26.00% | ||
Customer Revenue | Customer B | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 14.00% | 15.00% | 9.00% |
Customer Revenue | Customer C | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 14.00% | 16.00% | 12.00% |
Customer Revenue | Customer D | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 13.00% | ||
Customer Revenue | Customer E | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 10.00% | 14.00% | 9.00% |
Customer Revenue | Customer F | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 20.00% | 34.00% | |
Accounts Receivable | Customer A | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 33.00% | 45.00% | |
Accounts Receivable | Customer B | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 23.00% | 31.00% | |
Accounts Receivable | Customer C | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 16.00% | 10.00% |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Value added tax | $ 2,300,000 | ||||||||||
Revenue | $ 21,808,000 | $ 35,476,000 | $ 40,172,000 | $ 46,935,000 | $ 34,361,000 | $ 19,364,000 | $ 22,197,000 | $ 25,307,000 | $ 144,391,000 | $ 101,229,000 | $ 89,100,000 |
Revenue recognition cash discount percentage | 2.30% | 2.30% | |||||||||
Provision for chargebacks and other deductions included as reduction of accounts receivable total | $ 12,552,000 | 14,394,000 | $ 12,552,000 | 14,394,000 | |||||||
Deferred revenue | 1,147,000 | 218,000 | 1,147,000 | 218,000 | |||||||
Commercial Platform | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Provision for chargebacks and other deductions included as reduction of accounts receivable total | 12,551,000 | 14,393,000 | 12,551,000 | 14,393,000 | |||||||
Chargebacks and other revenue deductions expense | 89,300,000 | 87,200,000 | 36,500,000 | ||||||||
Oncology Innovation Platform | Out-license Revenue | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Deferred revenue | 1,000,000 | 1,000,000 | |||||||||
Global Supply Chain Platform | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Provision for chargebacks and other deductions included as reduction of accounts receivable total | 1,000 | 1,000 | 1,000 | 1,000 | |||||||
Global Supply Chain Platform | Out-license Revenue | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Deferred revenue | $ 100,000 | $ 200,000 | 100,000 | 200,000 | |||||||
Licensed IP | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Revenue recognized | 0 | ||||||||||
Revenue | 1,000,000 | ||||||||||
Transferred at a Point in Time | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Revenue recognized | 20,000,000 | ||||||||||
Revenue | $ 100,000 | ||||||||||
Type of Revenue [Extensible List] | atnx:LicenseForIntellectualPropertyMember | ||||||||||
Transferred at a Point in Time | Commercial Platform | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Revenue | 89,572,000 | $ 50,427,000 | 30,426,000 | ||||||||
Transferred at a Point in Time | Oncology Innovation Platform | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Revenue | 38,851,000 | 20,562,000 | 32,776,000 | ||||||||
Transferred at a Point in Time | Global Supply Chain Platform | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Revenue | 15,968,000 | $ 30,240,000 | $ 25,898,000 | ||||||||
Transferred at a Point in Time | Licensed IP | |||||||||||
Revenue Recognition Milestone Method [Line Items] | |||||||||||
Revenue recognized | $ 37,700,000 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Company's Revenue for Reportable Segment by Country Based on Locations of Customer (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 21,808 | $ 35,476 | $ 40,172 | $ 46,935 | $ 34,361 | $ 19,364 | $ 22,197 | $ 25,307 | $ 144,391 | $ 101,229 | $ 89,100 |
Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 100 | ||||||||||
Oncology Innovation Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 38,851 | 20,562 | 32,776 | ||||||||
Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 15,968 | 30,240 | 25,898 | ||||||||
Commercial Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 89,572 | 50,427 | 30,426 | ||||||||
United States | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 82,362 | 67,794 | 37,904 | ||||||||
United States | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 12,079 | 17,367 | 7,478 | ||||||||
United States | Commercial Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 70,283 | 50,427 | 30,426 | ||||||||
China | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 39,796 | 2,105 | 4,416 | ||||||||
China | Oncology Innovation Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 38,760 | 562 | 2,776 | ||||||||
China | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 1,036 | 1,543 | 1,640 | ||||||||
South Korea | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 2,354 | ||||||||||
South Korea | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 2,354 | ||||||||||
United Kingdom | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 19,289 | 1,023 | |||||||||
United Kingdom | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 1,023 | ||||||||||
United Kingdom | Commercial Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 19,289 | ||||||||||
Other Foreign Countries Including Austria | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 590 | ||||||||||
Other Foreign Countries Including Austria | Oncology Innovation Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 91 | ||||||||||
Other Foreign Countries Including Austria | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 499 | ||||||||||
Spain | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 20,000 | 30,000 | |||||||||
Spain | Oncology Innovation Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 20,000 | 30,000 | |||||||||
India | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 3,066 | 3,457 | |||||||||
India | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 3,066 | 3,457 | |||||||||
Austria | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 226 | 4,422 | 9,569 | ||||||||
Austria | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 4,422 | 9,569 | |||||||||
Other Foreign Countries Including South Korea | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 2,819 | ||||||||||
Other Foreign Countries Including South Korea | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 2,819 | ||||||||||
Other Foreign Countries | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 364 | $ 2,306 | 3,754 | ||||||||
Other Foreign Countries | Global Supply Chain Platform | Transferred at a Point in Time | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 3,754 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Receivables and Contract Liabilities From Contracts with Customers (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Change In Contract With Customer Liability [Abstract] | ||
Accounts receivable, gross | $ 45,792 | $ 31,207 |
Chargebacks and other deductions | (12,552) | (14,394) |
Provision for credit losses | (9,637) | (124) |
Accounts receivable, net | 23,603 | 16,689 |
Deferred revenue | 1,147 | 218 |
Total contract liabilities | $ 1,147 | $ 218 |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Accounts Receivable Balances by Reportable Segments (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accounts Receivable By Reportable Segments [Line Items] | ||
Accounts receivable, gross | $ 45,792 | $ 31,207 |
Chargebacks and other deductions | (12,552) | (14,394) |
Provision for credit losses | (9,637) | (124) |
Accounts receivable, net | 23,603 | 16,689 |
Oncology Innovation Platform | ||
Accounts Receivable By Reportable Segments [Line Items] | ||
Accounts receivable, gross | 10,783 | 49 |
Provision for credit losses | (8,919) | |
Accounts receivable, net | 1,864 | 49 |
Global Supply Chain Platform | ||
Accounts Receivable By Reportable Segments [Line Items] | ||
Accounts receivable, gross | 4,074 | 1,522 |
Chargebacks and other deductions | (1) | (1) |
Provision for credit losses | (164) | (114) |
Accounts receivable, net | 3,909 | 1,407 |
Commercial Platform | ||
Accounts Receivable By Reportable Segments [Line Items] | ||
Accounts receivable, gross | 30,935 | 29,636 |
Chargebacks and other deductions | (12,551) | (14,393) |
Provision for credit losses | (554) | (10) |
Accounts receivable, net | $ 17,830 | $ 15,233 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) - Schedule of Quarterly Results of Operations (Unaudited) (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | |||||||||||
Total revenue | $ 21,808 | $ 35,476 | $ 40,172 | $ 46,935 | $ 34,361 | $ 19,364 | $ 22,197 | $ 25,307 | $ 144,391 | $ 101,229 | $ 89,100 |
Cost of sales | 18,267 | 24,510 | 33,006 | 19,572 | 15,704 | 17,071 | 16,942 | 19,902 | 95,355 | 69,619 | 47,005 |
Gross profit | 3,541 | 10,966 | 7,166 | 27,363 | 18,657 | 2,293 | 5,255 | 5,405 | 49,036 | 31,610 | 42,095 |
Operating expenses: | |||||||||||
Research and development expenses | 18,307 | 18,390 | 22,015 | 17,192 | 21,823 | 19,588 | 18,507 | 24,475 | 75,904 | 84,393 | 119,905 |
Selling, general, and administrative expenses | 31,401 | 22,220 | 17,486 | 25,748 | 18,109 | 16,283 | 17,169 | 15,188 | 96,855 | 66,749 | 49,008 |
Total operating expenses | 49,708 | 40,610 | 39,501 | 42,940 | 39,932 | 35,871 | 35,676 | 39,663 | 172,759 | 151,142 | 168,913 |
Operating loss | (46,167) | (29,644) | (32,335) | (15,577) | (21,275) | (33,578) | (30,421) | (34,258) | (123,723) | (119,532) | (126,818) |
Net loss | (50,397) | (37,268) | (41,051) | (19,718) | (22,411) | (34,787) | (32,105) | (36,230) | (148,434) | (125,533) | (128,711) |
Less: net loss attributable to non-controlling interests | (904) | (462) | (600) | (289) | (684) | (29) | (74) | (997) | (2,255) | (1,784) | (11,271) |
Total consolidated net loss attributable to Athenex, Inc. | $ (49,493) | $ (36,806) | $ (40,451) | $ (19,429) | $ (21,727) | $ (34,758) | $ (32,031) | $ (35,233) | $ (146,179) | $ (123,749) | $ (117,440) |
Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted | $ (0.53) | $ (0.44) | $ (0.50) | $ (0.24) | $ (0.28) | $ (0.45) | $ (0.44) | $ (0.53) | $ (1.72) | $ (1.67) | $ (1.82) |
Product Sales, Net | |||||||||||
Revenue: | |||||||||||
Total revenue | $ 21,780 | $ 24,780 | $ 40,167 | $ 18,547 | $ 14,102 | $ 19,237 | $ 22,033 | $ 25,163 | $ 105,274 | $ 80,535 | $ 56,394 |
License and Other Revenue | |||||||||||
Revenue: | |||||||||||
Total revenue | $ 28 | $ 10,696 | $ 5 | $ 28,388 | $ 20,259 | $ 127 | $ 164 | $ 144 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Sep. 04, 2017USD ($) | Nov. 30, 2019 | Oct. 31, 2015¥ / SquareMeter | Jul. 31, 2015USD ($) | Dec. 31, 2020USD ($)¥ / SquareMeter | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Oct. 31, 2016USD ($) |
Deferred rent liability | $ 1,700,000 | |||||||
Rent expense | $ 1,000,000 | $ 1,000,000 | 1,000,000 | |||||
Lease facilities rental agreement duration | 10 years | |||||||
Lease expiration terms | expire at various times through 2026 | |||||||
Lease term | 10 years | |||||||
Renewal lease term | 10 years | |||||||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 | |||||||
Grant Disbursement Agreement | ||||||||
Lease facilities rental agreement duration | 10 years | 10 years | ||||||
Purchase rate of equipment per year in first 10 year term | $ 1 | $ 1 | ||||||
Purchase rate of equipment per year in second 10 year term | 1 | 1 | ||||||
Operating expenses committed to spent in first 10 year term | 1,520,000,000 | 1,520,000,000 | ||||||
Operating expenses committed to spent in second 10 year term | $ 1,500,000,000 | $ 1,500,000,000 | ||||||
Lease term | 10 years | 10 years | ||||||
Renewal lease term | 10 years | 10 years | ||||||
Lessee, operating lease, option to extend | option to extend the lease for an additional 10-year term | |||||||
Lessee, operating lease, existence of option to extend [true false] | true | |||||||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 | |||||||
China | ||||||||
Rent expense | $ 600,000 | 600,000 | 600,000 | |||||
Commercial Platform | ||||||||
Deferred rent liability | 300,000 | |||||||
Rent expense | 300,000 | 300,000 | 300,000 | |||||
Irrevocable letter of credit issued | $ 200,000 | |||||||
Maximum | Grant Disbursement Agreement | ||||||||
Construction costs | 208,000,000 | |||||||
CDE | ||||||||
Rent expense | $ 100,000 | $ 300,000 | $ 400,000 | |||||
Lease facilities rental agreement duration | 3 years | |||||||
Agreement expiration date | 2022-11 | 2019-11 | ||||||
Lease term | 3 years | |||||||
CDE | Maximum | ||||||||
Monthly rental payment | $ 100,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Payments Under Non-Cancelable Leases (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2021 | $ 3,454 |
2022 | 2,927 |
2023 | 2,096 |
2024 | 2,002 |
2025 | 1,472 |
Thereafter | 478 |
Total lease payments | $ 12,429 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) $ in Millions | Feb. 15, 2021USD ($) | Jan. 05, 2021m²¥ / SquareMeter | Oct. 31, 2015¥ / SquareMeter |
Subsequent Event [Line Items] | |||
Lease term | 10 years | ||
Renewal lease term | 10 years | ||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 | ||
Subsequent Event | 2011 License Agreement | Pharma Essentia | Tirbanibulin Ointment | |||
Subsequent Event [Line Items] | |||
Upfront payment received | $ | $ 0.5 | ||
Milestone payments associated with achievement of certain development and sales milestone | $ | $ 13 | ||
Chinese Subsidiaries | API Facility or Sintaho API Facility | Chongqing International Biological City Development & Investment Co., Ltd | Subsequent Event | |||
Subsequent Event [Line Items] | |||
Area of rent free lease | m² | 34,517 | ||
Lease term | 10 years | ||
Renewal lease term | 10 years | ||
Payment of monthly rent per square meter | ¥ / SquareMeter | 5 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Balance at Beginning of Period | $ 124 | $ 9 | $ 84 | |
Charged to Costs & Expenses | [1] | 9,577 | 488 | 28 |
Deductions | [1] | (64) | (373) | (103) |
Balance at End of Period | 9,637 | 124 | 9 | |
Allowance for chargebacks and other deductions | ||||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Balance at Beginning of Period | 14,394 | 13,101 | 3,711 | |
Charged to Costs & Expenses | [2] | 90,237 | 95,100 | 36,102 |
Deductions | [2] | (92,079) | (93,807) | (26,712) |
Balance at End of Period | 12,552 | 14,394 | 13,101 | |
Deferred tax asset valuation allowance | ||||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Balance at Beginning of Period | 120,805 | 88,455 | 60,379 | |
Charged to Other Accounts | [3] | 30,059 | 32,350 | 28,076 |
Balance at End of Period | $ 150,864 | $ 120,805 | $ 88,455 | |
[1] | Increases in the provision for credit losses consist of our provision for credit losses, which is included within selling, general, and administrative expenses on the consolidated statements of operations and comprehensive loss. Decreases in the provision for credit losses consist of the write-off of specific accounts and the recovery of previously reserved receivables. | |||
[2] | Increases in the allowance for chargebacks and other deductions consist of our provision for chargebacks, cash discounts, returns, fees, and other credits, which are a deduction from product sales on the consolidated statements of operations and comprehensive loss. Decreases in the allowances for chargebacks and other deduction consist of the collection of the underlying accounts and advances received on chargebacks. | |||
[3] | Increases and decreases in the valuation allowance for deferred income tax assets offset the increases and decreases in our gross deferred tax assets, based on the expected realization of those future tax benefits. |