Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 06, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2020 | |
Entity File Number | 0-20713 | |
Entity Registrant Name | CASI Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 58-1959440 | |
Entity Address, Address Line One | 9620 Medical Center Drive, Suite 300 | |
Entity Address, City or Town | Rockville | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20850 | |
City Area Code | (240) | |
Local Phone Number | 864-2600 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | CASI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Entity Interactive Data Current | Yes | |
Entity Central Index Key | 0000895051 | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 123,943,829 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 74,592 | $ 53,621 |
Investment in equity securities, at fair value | 1,796 | 625 |
Accounts receivable, net of $0 allowance for doubtful accounts | 4,078 | 1,293 |
Inventories | 720 | 4,542 |
Prepaid expenses and other | 1,794 | 1,420 |
Assets held-for-sale | 298 | 3,221 |
Total current assets | 83,278 | 64,722 |
Property and equipment, net | 984 | 985 |
Intangible assets, net | 13,015 | 13,674 |
Long-term investments | 27,569 | 14,038 |
Right of use assets | 9,015 | 8,708 |
Other assets | 377 | 504 |
Total assets | 134,238 | 102,631 |
Current liabilities: | ||
Accounts payable | 2,697 | 5,113 |
Accrued and other current liabilities | 2,858 | 2,834 |
Total current liabilities | 5,555 | 7,947 |
Deferred Income | 2,270 | 0 |
Other liabilities | 13,615 | 1,019 |
Total liabilities | 21,440 | 8,966 |
Commitments and contingencies (Note 19) | ||
Redeemable noncontrolling interest, at redemption value (Note 11) | 21,271 | 20,670 |
Stockholders' equity: | ||
Preferred stock, $1.00 par value: 5,000,000 shares authorized and 0 shares issued and outstanding | 0 | 0 |
Common stock, $0.01 par value: 250,000,000 shares authorized at September 30, 2020 and December 31, 2019 ; 124,023,374 shares and 97,851,243 shares issued at September 30, 2020 and December 31, 2019, respectively; 123,943,829 shares and 97,771,698 shares outstanding at September 30,2020 and December 31, 2019, respectively | 1,240 | 979 |
Additional paid-in capital | 656,639 | 606,686 |
Treasury stock, at cost: 79,545 shares held at September 30, 2020 and December 31, 2019 | (8,034) | (8,034) |
Accumulated other comprehensive loss | (1,507) | (2,728) |
Accumulated deficit | (556,811) | (523,908) |
Total stockholders' equity | 91,527 | 72,995 |
Total liabilities, redeemable noncontrolling interest and stockholders' equity | $ 134,238 | $ 102,631 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Condensed Consolidated Balance Sheets | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 1 | $ 1 |
Preferred Stock, Shares Authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued (in shares) | 0 | 0 |
Preferred Stock, Shares Outstanding (is shares) | 0 | 0 |
Common Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 |
Common Stock, Shares Issued (in shares) | 124,023,374 | 97,851,243 |
Common Stock, Shares Outstanding (in shares) | 123,943,829 | 97,771,698 |
Treasury stock, shares held (in shares) | 79,545 | 79,545 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues: | ||||
Product sales | $ 4,205 | $ 2,749 | $ 10,215 | $ 2,749 |
Lease income | 37 | 38 | 104 | 38 |
Total revenues | 4,242 | 2,787 | 10,319 | 2,787 |
Costs and expenses: | ||||
Costs of revenues | 1,828 | 2,648 | 7,556 | 2,648 |
Research and development | 2,803 | 1,829 | 7,682 | 7,375 |
General and administrative | 5,347 | 7,977 | 13,490 | 20,669 |
Selling and marketing | 2,062 | 975 | 4,879 | 975 |
(Gain) loss on disposal of intangible assets | 0 | 0 | (450) | 48 |
Impairment of intangible assets | 0 | 0 | 1,537 | 0 |
Acquired in-process research and development | 10,862 | 0 | 11,943 | 5,849 |
Total cost and expenses | 22,902 | 13,429 | 46,637 | 37,564 |
Loss from operations | (18,660) | (10,642) | (36,318) | (34,777) |
Non-operating income/(expense): | ||||
Interest income, net | 432 | 414 | 775 | 783 |
Other income | 20 | 0 | 47 | 0 |
Foreign exchange (losses) gains | (526) | 719 | (278) | 1,269 |
Change in fair value of investment in equity securities | 1,978 | (160) | 2,287 | (355) |
Net loss | (16,756) | (9,669) | (33,487) | (33,080) |
Less: (loss)/income attributable to redeemable noncontrolling interest | (309) | (23) | (584) | 53 |
Accretion to redeemable noncontrolling interest redemption value | 506 | 245 | 1,185 | 406 |
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (16,953) | $ (9,891) | $ (34,088) | $ (33,539) |
Net loss per share (basic and diluted) (in dollars per share) | $ (0.14) | $ (0.10) | $ (0.32) | $ (0.35) |
Weighted average number of common shares outstanding (basic and diluted) | 117,940 | 95,891 | 105,922 | 95,753 |
Comprehensive loss: | ||||
Net loss | $ (16,756) | $ (9,669) | $ (33,487) | $ (33,080) |
Foreign currency translation adjustment | 2,383 | (1,836) | 1,221 | (2,636) |
Total comprehensive loss | (14,373) | (11,505) | (32,266) | (35,716) |
Less: Comprehensive (loss)/income attributable to redeemable noncontrolling interest | (309) | (23) | (584) | 53 |
Comprehensive loss attributable to common stockholders | $ (14,064) | $ (11,482) | $ (31,682) | $ (35,769) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2018 | $ 0 | $ 954 | $ 596,712 | $ (8,034) | $ (1,227) | $ (478,941) | $ 109,464 |
Balance (in Shares) at Dec. 31, 2018 | 0 | 95,287,268 | |||||
Issuance of common stock for options exercised | $ 0 | $ 1 | 113 | 0 | 0 | 0 | 114 |
Issuance of common stock for options exercised (in shares) | 0 | 64,137 | |||||
Issuance of common stock for options and warrants exercised (in shares) | 0 | ||||||
Repurchase of stock options to satisfy tax withholding obligations | $ 0 | $ 0 | (12) | 0 | 0 | 0 | (12) |
Stock issuance costs | 0 | 0 | (8) | 0 | 0 | 0 | (8) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 5,320 | 0 | 0 | 0 | 5,320 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | (2,636) | 0 | (2,636) |
Issuance of common stock from exercise of warrants | 0 | $ 9 | 1,659 | 0 | 0 | 0 | 1,668 |
Issuance of common stock from exercise of warrants (in shares) | 987,653 | ||||||
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | $ 0 | (406) | 0 | 0 | (33,133) | (33,539) |
Balance at Sep. 30, 2019 | $ 0 | $ 964 | 603,378 | (8,034) | (3,863) | (512,074) | 80,371 |
Balance (in shares) at Sep. 30, 2019 | 0 | 96,339,058 | |||||
Balance at Jun. 30, 2019 | $ 0 | $ 958 | 600,569 | (8,034) | (2,027) | (502,428) | 89,038 |
Balance (in Shares) at Jun. 30, 2019 | 0 | 95,717,052 | |||||
Issuance of common stock for options exercised | $ 0 | $ 0 | 75 | 0 | 0 | 0 | 75 |
Issuance of common stock for options exercised (in shares) | 0 | 45,875 | |||||
Issuance of common stock from exercise of warrants | $ 0 | $ 6 | 968 | 0 | 0 | 0 | 974 |
Issuance of common stock from exercise of warrants (in shares) | 0 | 576,131 | |||||
Stock-based compensation expense, net of forfeitures | $ 0 | $ 0 | 2,011 | 0 | 0 | 0 | 2,011 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | (1,836) | 0 | (1,836) |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (245) | 0 | 0 | (9,646) | (9,891) |
Balance at Sep. 30, 2019 | $ 0 | $ 964 | 603,378 | (8,034) | (3,863) | (512,074) | 80,371 |
Balance (in shares) at Sep. 30, 2019 | 0 | 96,339,058 | |||||
Balance at Dec. 31, 2019 | $ 0 | $ 979 | 606,686 | (8,034) | (2,728) | (523,908) | $ 72,995 |
Balance (in Shares) at Dec. 31, 2019 | 0 | 97,771,698 | |||||
Issuance of common stock for options exercised (in shares) | 2,789,473 | ||||||
Issuance of common stock for options and warrants exercised | $ 0 | $ 27 | 3,847 | 0 | 0 | 0 | $ 3,874 |
Issuance of common stock for options and warrants exercised (in shares) | 0 | 2,737,795 | |||||
Repurchase of stock options to satisfy tax withholding obligations | $ 0 | $ 0 | (251) | 0 | 0 | 0 | (251) |
Issuance of common stock from exercise of warrants (in shares) | 0 | ||||||
Issuance of common stock pursuant to financing agreements | $ 0 | $ 234 | 44,865 | 0 | 0 | 0 | 45,099 |
Issuance of common stock pursuant to financing agreements (in shares) | 23,434,336 | ||||||
Stock issuance costs | 0 | $ 0 | (3,008) | 0 | 0 | 0 | (3,008) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 5,685 | 0 | 0 | 0 | 5,685 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 1,221 | 0 | 1,221 |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (1,185) | 0 | 0 | (32,903) | (34,088) |
Balance at Sep. 30, 2020 | $ 0 | $ 1,240 | 656,639 | (8,034) | (1,507) | (556,811) | 91,527 |
Balance (in shares) at Sep. 30, 2020 | 0 | 123,943,829 | |||||
Balance at Jun. 30, 2020 | $ 0 | $ 1,010 | 614,617 | (8,034) | (3,890) | (540,364) | 63,339 |
Balance (in Shares) at Jun. 30, 2020 | 0 | 100,928,829 | |||||
Issuance of common stock for options exercised | $ 0 | $ 0 | 22 | 0 | 0 | 0 | 22 |
Issuance of common stock for options exercised (in shares) | 0 | 15,000 | |||||
Issuance of common stock pursuant to financing agreements | $ 0 | $ 230 | 43,470 | 0 | 0 | 0 | 43,700 |
Issuance of common stock pursuant to financing agreements (in shares) | 23,000,000 | ||||||
Stock issuance costs | 0 | $ 0 | (2,757) | 0 | 0 | 0 | (2,757) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 1,793 | 0 | 0 | 0 | 1,793 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 2,383 | 0 | 2,383 |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (506) | 0 | 0 | (16,447) | (16,953) |
Balance at Sep. 30, 2020 | $ 0 | $ 1,240 | $ 656,639 | $ (8,034) | $ (1,507) | $ (556,811) | $ 91,527 |
Balance (in shares) at Sep. 30, 2020 | 0 | 123,943,829 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (33,487) | $ (33,080) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization for property and equipment | 389 | 561 |
Net loss on disposal of property and equipment | 0 | 1 |
Amortization of intangible assets | 1,095 | 1,182 |
Reduction in the carrying amount of the right-of-use assets | 973 | 742 |
(Gain) loss on disposal of intangible assets | (450) | 48 |
Impairment of intangible assets | 1,537 | 0 |
Stock-based compensation expense | 5,685 | 5,320 |
Acquired in-process research and development | 11,943 | 5,849 |
Change in fair value of investment in equity securities | (2,287) | 355 |
Non-cash interest | 0 | 1 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,785) | (2,643) |
Inventories | 3,822 | (2,282) |
Prepaid expenses and other assets | (434) | 2,796 |
Accounts payable | (2,434) | 3,877 |
Accrued liabilities and other liabilities | (1,398) | (1,152) |
Deferred income | (23) | 0 |
Net cash used in operating activities | (17,854) | (18,425) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from disposal of intangible assets | 1,700 | 0 |
Purchases of property and equipment | (367) | (390) |
Loan to a related party | (10,033) | 0 |
Receipt of repayment of loan from a related party | 10,033 | 0 |
Cash paid for acquired in-process research and development | (11,678) | (5,849) |
Cash paid to acquire equity securities in Black Belt Tx Limited | 0 | (2,250) |
Cash paid to acquire debt securities in Black Belt Tx Limited | (83) | 0 |
Cash paid to acquire equity securities in Juventas Cell Therapy Ltd | (11,788) | |
Receipt of government grants related to land use right | 2,278 | 0 |
Net cash used in investing activities | (8,150) | (20,277) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from note payable | 466 | |
Repayment of notes payable | (1,500) | |
Stock issuance costs | (2,800) | (8) |
Proceeds from issuance of common stock | 45,099 | 0 |
Cash contribution from redeemable noncontrolling interest | 0 | 20,000 |
Proceeds from exercise of stock options | 3,874 | 114 |
Repurchase of stock options to satisfy tax withholding obligations | (251) | (12) |
Proceeds from exercise of warrants | 0 | 1,668 |
Payment of deferred offfering costs | 0 | (369) |
Net cash provided by financing activities | 46,388 | 19,893 |
Effect of exchange rate change on cash and cash equivalents | 587 | (2,155) |
Net increase (decrease) in cash and cash equivalents | 20,971 | (20,964) |
Cash and cash equivalents at beginning of period | 53,621 | 84,205 |
Cash and cash equivalents at end of period | 74,592 | 63,241 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 0 | 30 |
Income taxes paid | $ 0 | $ 0 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
Basis of Presentation | |
Basis of Presentation | 1. Basis of Presentation CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd. ("CASI China"), which is located in Beijing, China. The Company has built a commercial team of over 70 hematology and oncology sales and marketing specialists based in China. In August 2019, the Company launched its first commercial product, EVOMELA ® ● An autologous CD19 CAR-T investigative product (CNCT19) being developed by Juventas Cell Therapy Ltd (“Juventas”) as a treatment for patients with B-cell acute lymphoblastic leukemia (“B-ALL”) and B-cell non-Hodgkin lymphoma (“B-NHL"). The Company has commercialization rights for CNCT19 with profit-sharing to Juventas. Phase 1 studies has been substantially completed and Juventas expects the Phase II studies will start by the end of 2020. ● CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma. The Company intends to initiate the Phase 1 study of CID-103 in the first quarter of 2021. ● ZEVALIN ® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody, that is approved in the U.S. to treat patients with non-Hodgkin lymphoma (“NHL”). The Company intends to begin the China registration study of ZEVALIN in 2021. Other assets in the Company’s pipeline for which the Company have exclusive rights in China are (i) Octreotide Long Acting Injectable (“LAI”), and (ii) a novel formulation of Thiotepa. Octreotide LAI formulations, which are approved in various European countries, are considered a standard of care for the treatment of acromegaly and the control of symptoms associated with certain neuroendocrine tumors. The Company plans to begin the China registration study for Octreotide LAI in 2020. Thiotepa is a conditioning treatment for allogeneic haemopoietic stem cell transplants. The Company’s partner for the novel formulation of Thiotepa plans to begin the China registration study in 2021. In October 2020, we added to our portfolio of assets BI-1206 which has a novel mode-of-action, blocking the single inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity in both hematological malignancies and solid tumors. BI-1206 is BioInvent's lead drug candidate and is being investigated in a Phase I/II trial, in combination with anti-PD1 therapy Keytruda ® ® The Company intends to continue to pursue building a robust pipeline of drug candidates for development and commercialization in China as its primary market and, if rights are available, for the rest of the world. For in-licensed products, the Company uses a market-oriented approach to identify pharmaceutical candidates that it believes have the potential for gaining widespread market acceptance, either globally or in China, and for which development can be accelerated under the Company’s drug development strategy. The Company’s strategy focuses on product candidates with proven targets or product candidates that have low clinical risk. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, in which CASI, directly or indirectly, has a controlling financial interest. These subsidiaries include Miikana Therapeutics, Inc. (“Miikana”), CASI Pharmaceuticals (China) Co., Ltd. (“CASI China”), CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”), and CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”). CASI China is a non-stock Chinese entity with 100% of its interest owned by CASI. CASI China received approval for a business license from the Beijing Industry and Commercial Administration in August 2012 and has operating facilities in Beijing. CASI Wuxi was established on December 26, 2018 in China to develop a future manufacturing facility in China. CASI Biopharmaceuticals is a wholly owned subsidiary of CASI Wuxi and was established in April 2019. The Company controls CASI Wuxi through 80% voting rights (see Note 11). Accordingly, the financial statements of CASI Wuxi have been consolidated in the Company’s consolidated financial statements since its inception. All inter-company balances and transactions have been eliminated in consolidation. The Company currently operates in one operating segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such condensed consolidated financial statements do not include all of the information and disclosures required by U.S. generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. The accompanying December 31, 2019 financial information was derived from the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated balance sheet of the Company as of December 31, 2019 and the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the year then ended. Certain line items in the 2019 consolidated balance sheet, in the September 30, 2019 unaudited condensed consolidated statement of operations and comprehensive loss and in the September 30, 2019 unaudited condensed consolidated statement of cash flows have been reclassified to conform to the current period presentation. Liquidity Risks and Management’s Plans Since its inception in 1991, the Company has incurred significant losses from operations and, as of September 30, 2020, has incurred an accumulated deficit of $556.8 million. In 2012, the Company shifted its business strategy to China and has since built an infrastructure in China that includes sales and marketing, medical affairs, and regulatory and clinical development. In 2014, the Company changed its name to "CASI Pharmaceuticals, Inc." The majority of the Company's operations are now located in China. The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities. On July 24, 2020, the Company closed an underwritten public offering of 23 million shares of common stock (the "Offering") and received gross proceeds of approximately $43.7 million before deducting the underwriting discounts and commissions and offering expenses payable by CASI. Certain insiders, including CASI's Chief Executive Officer, and CASI's President, purchased shares of common stock in the Offering at the public offering price and on the same terms as the other purchasers in this Offering (see Note 12). The Company is using the net proceeds of this offering for working capital and general corporate purposes, which include, but are not limited to advancing the Company's product portfolio, acquiring the rights to new product candidates and general and administrative expenses. Taking into consideration the cash and cash equivalents balance as of September 30, 2020, the Company believes that it has sufficient resources to fund its operations at least one year beyond the date that the unaudited condensed consolidated financial statements are issued. As of September 30, 2020, approximately $4.2 million of the Company’s cash balance was held by CASI China, and approximately $20.4 million of the Company’s cash balance was held by CASI Wuxi. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements. Risks and Uncertainties The Company's business has been and may continue to be adversely affected by the COVID-19 pandemic. In March 2020, the World Health Organization characterized the outbreak of COVID-19 as a pandemic. Due to the evolving and highly uncertain nature of this event, the Company cannot predict at this time the full extent to which the COVID-19 pandemic will adversely impact its business, results and financial condition. The impact will depend on many factors that are not known at this time. These include, among others, the extent of harm to public health, the continued disruption to operations, and the impact of the global business and economic environment on liquidity and the availability of capital. The Company has experienced operational interruptions as a result of COVID-19, including the temporary disruption of operations in China due to a Chinese government mandated quarantine protocol, including mandatory business closures, social distancing measures, and various travel restrictions. Although the Company's operations in China are beginning to normalize, there can be no assurance that such operations will continue to do so or that there will not be a renewed outbreak of COVID-19 or other significant contagious diseases in China or elsewhere. To the extent that such events occur, demand for the Company's products may decline, and the Chinese government or other governments may impose additional restrictions resulting in further shutdowns, further work restrictions, and the disruption of the Company’s supply and distribution channels. The COVID-19 pandemic has adversely affected, and may continue to adversely affect, the economies and financial markets of many countries, which may result in a period of regional, national, and global economic slowdown or regional, national, or global recessions that could affect the Company's ability to continue to commercialize and expand distribution of EVOMELA (Melphalan For Injection) or other drugs in the Company’s existing product pipeline. The effectiveness of the Company's sales teams may be negatively impacted by the lack of travel and their reduced ability to engage with decision-makers. In the first quarter 2020, during which the peak of the pandemic occurred in China, the Company experienced some disruptions to our EVOMELA marketing and sales activities due to travel restrictions and the prioritization of hospitals and physicians to attend to patients with COVID-19 infection. During the second and third quarters, operations have returned to expected levels; however, there can be no assurance that such restrictions will not be imposed again. In addition, economic and other uncertainties may adversely affect other parties' willingness to negotiate and execute product licenses and thus hamper the Company's ability to in-license clinical-stage and late-stage drug candidates in China or elsewhere. The Company currently relies on a single source for its supply of EVOMELA. Due to COVID-19, the Company experienced a disruption to its supply chain for EVOMELA. That disruption, along with a recent change in the manufacturer of EVOMELA, contributed to a decrease in the Company's revenue for the second quarter of 2020. The Company has returned to expected levels of sales as indicated by the increase in sales in the third quarter of 2020. If suppliers refuse or are unable to provide products for any reason (including the occurrence of an event like the COVID-19 pandemic that makes delivery impractical), the Company would be required to negotiate an agreement with a substitute supplier, which would likely interrupt the manufacturing of EVOMELA, cause delays and increase costs. Clinical trials, whether planned or ongoing, may be affected by the COVID-19 pandemic. The Company's partner, Juventas, experienced some delay in the conduct of the CNCT19 trials due to the COVID-19 pandemic. The COVID-19 pandemic has also impacted the Company's targeted start time of our CID-103 trial due to the lock-down of many medical facilities in Europe. Study procedures (particularly any procedures that may be deemed non-essential), site initiation, participant recruitment and enrollment, participant dosing, shipment of the Company's product candidates, distribution of clinical trial materials, study monitoring, site inspections and data analysis may be paused or delayed due to changes in hospital or research institution policies, federal, state or local regulations, prioritization of hospital and other medical resources toward COVID-19 efforts, or other reasons related to the pandemic. In addition, there could be a potential effect of COVID-19 on the operations of the health regulatory authorities, which could result in delays of reviews and approvals, including with respect to the Company's product candidates. Any prolongation or de-prioritization of the Company's clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of the Company's product candidates. |
License and Distribution Agreem
License and Distribution Agreements | 9 Months Ended |
Sep. 30, 2020 | |
License and Distribution Agreements | |
License and Distribution Agreements | 2. License and Distribution Agreements Pharmathen Global BV: On October 29, 2019, the Company entered into an exclusive distribution agreement with Pharmathen Global BV (“Pharmathen”) for the development and distribution of octreotide long acting injectable (Octreotide LAI) microsphere in China. Octreotide LAI formulations are considered a standard of care for the treatment of acromegaly and for the control of symptoms associated with certain neuroendocrine tumors. Octreotide LAI has been approved in various European countries. CASI intends to advance the development, import drug registration, and market approval of this product in China. The Company expects to initiate an Octreotide LAI registration study in China in 2020. The terms of the agreement include an upfront payment of 1 million euros which was paid by the Company in 2019, and up to 2 million euros of additional milestone payments. During the nine months ended September 30, 2020, milestones were achieved related to Pharmathen’s approval of Octreotide in the UK, which triggered a 1 million euros payment to Pharmathen, and related to the first submission to the National Medical Products Administration in China, triggering a 500,000 euros payment to Pharmathen. The 1.5 million euros (approximately $ 1.7 million) was expensed as acquired in-process research and development in the accompanying unaudited condensed consolidated statement of operations and comprehensive income for the nine months ended September 30, 2020. CASI is responsible for the development, import drug registration, product approval and commercialization in China. CASI has a 10-year non-royalty exclusive distribution period after the product launch at agreed supply costs for the first three years . Juventas Cell Therapy: In June 2019, the Company entered into a license agreement for exclusive worldwide license to commercialize an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. (“Juventas”) (the “Juventas license agreement”). Juventas is a China-based company engaged in cell therapy. The terms of the agreement include RMB 70 million (approximately $ 10 million) of milestone payments upon the registration of Phase II clinical trial of CNCT19 and sales royalty payments. The milestone became probable to be met during the quarter ended September 30, 2020. As a result, the Company paid the milestone payment of RMB 70 million to Juventas in September 2020 (see Note 4). In September 2020, Juventas and its shareholders (including CASI Biopharmaceuticals) agreed to certain terms and conditions required by a new third-party investor to facilitate the Series B financing of Juventas, pursuant to which the Company agreed to amend and supplement the original licensing agreement (the “Supplementary Agreement”) by agreeing to pay Juventas certain percentage of profits generated from commercial sales of CNCT19. The Supplementary Agreement also specifies a minimum annual target net profit to be distributed to Juventas and certain other terms and obligations. In return, Juventas issued additional equity interests to the Company (see Note 4). CNCT19 was engineered from the CD19 CAR-T, to potentially treat patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). The China National Medical Products Administration (NMPA) has approved the clinical trial applications for CNCT19 in Phase 1 studies in relapsed/refractory B-NHL and B-ALL. Both trials are conducted by Juventas and are currently enrolling patients. Phase 1 studies has been substantially completed and Juventas expects the Phase II studies will start by the end of 2020. Black Belt Therapeutics Limited: In April 2019, the Company entered into a license agreement with Black Belt Therapeutics Limited (“Black Belt”) for exclusive worldwide rights to CID-103, an investigational anti-CD38 monoclonal antibody (Mab) (formerly known as TSK011010). The terms of the agreement include an upfront payment of €5 million and certain development milestone and sales royalty payments. CASI is responsible for all development and commercialization activities of the CID-103 program. The Company expects to initiate a Phase I study in the UK in the first quarter of 2021. China Resources Guokang Pharmaceuticals Co., Ltd: In March 2019, CASI entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd. (“CRGK” or the “distributor”), pursuant to which it is the sole customer and distributor for the sale of EVOMELA in China. Commercial sales of EVOMELA were launched in August 2019. For the three and nine months ended September 30, 2020, the Company recognized $4.2 million and $10.2 million of revenues, respectively, from sales of EVOMELA under this arrangement. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Revenue Recognition The Company recognizes revenue using the following steps: ● Identification of the contract, or contracts, with a customer; ● Identification of the performance obligations in the contract; ● Determination of the transaction price, including the identification and estimation of variable consideration; ● Allocation of the transaction price to the performance obligations in the contract; and ● Recognition of revenue when we satisfy a performance obligation. The Company recognizes revenue on sales of EVOMELA when the control of the product is transferred to the distributor, which occurs upon delivery of the product to the distributor, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product, excluding amounts collected on behalf of third parties (e.g. value-added taxes). Payment terms for these sales are due within 90 days. The arrangement does not include any variable consideration. The costs of assurance type warranties that provide the customer the right to exchange purchased product that does not meet appropriate quality standards are recognized when they are probable and are reasonably estimable. As of September 30, 2020, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of September 30, 2020. Costs of Revenues Cost of revenues consists primary of the cost of inventories of EVOMELA and sales-based royalties related to the sale of EVOMELA. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to recoverability of operating lease right-of-use assets, intangible assets and long-term investments, net realizable value and obsolescence allowance for inventory, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments in equity securities in Juventas. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements. Accounts Receivable and Credit Concentration CRGK is the sole customer for the sale of the Company’s EVOMELA product in China. All consolidated revenue for the three and nine months ended September 30, 2020 were generated from sales to CRGK in China. Accounts receivable consist of CRGK receivables of $4.1 million and $1.3 million as of September 30, 2020 and December 31, 2019, respectively. The Company extends credit to CRGK on an unsecured basis and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable. In establishing the required allowance, management considers the historical losses, customer’s financial condition, the amount of accounts receivables in dispute, the accounts receivables aging and the customer’s payment pattern. The Company determined that no allowance for doubtful accounts was necessary as of September 30, 2020. Government Grants Government grants are recognized when there is reasonable assurance that the Company will comply with required conditions and the grants will be received. Government grants related to assets are presented as deferred income that is recognized on a systematic basis over the useful life of the asset. New Accounting Pronouncements Recently Adopted Pronouncements In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) . |
Investment in Equity Securities
Investment in Equity Securities, at fair value and long-term investments | 9 Months Ended |
Sep. 30, 2020 | |
Investment in Equity Securities, at fair value and long-term investments | |
Investment in Equity Securities, at fair value and long-term investments | 4. Investment in equity securities, at fair value and long-term investments Investment in equity securities, at fair value The Company has an equity investment in the common stock of a publicly traded company. The fair value of this security was measured using its quoted market price, a Level 1 input, and was approximately $1.8 million as of September 30, 2020 and $0.6 million as of December 31, 2019 (see Note 16). The following table summarizes the Company’s investment as of September 30, 2020: Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains value Common stock Investment $ — $ 1,796 $ 1,796 Unrealized gains or (losses) on the Company’s equity investment for the three months ended September 30, 2020 and 2019 were $862,000 and $(160,000), respectively. Unrealized gains or (losses) on the Company’s equity investment for the nine months ended September 30, 2020 and 2019 were $1,171,000 and $(355,000), respectively. Unrealized gains or (losses) on the Company’s equity investment are recognized as change in fair value of investment in equity securities in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. Long-term investments Long-term investments consisted of the following: (In thousands) September 30, 2020 December 31, 2019 Available-for-sale debt securities: Black Belt Tx Limited - convertible loan $ 83 $ — Equity securities without readily determinable fair value: Black Belt Tx Limited - equity interest 2,250 2,250 Juventas Cell Therapy Limited - equity interest 25,035 11,355 Juventas Cell Therapy Limited - put option 201 433 Total $ 27,569 $ 14,038 Black Belt Tx Limited In April 2019, in conjunction with its license agreement entered into with Black Belt (see Note 2), the Company made a 2 million euros ($2,249,600) equity investment in the ordinary shares of a newly established, privately held UK Company, Black Belt Tx Ltd ("Black Belt Tx"), representing a 14.1% equity interest with the right to appoint a non-voting board observer. In July 2020, the Company entered into a three-year convertible loan agreement with Black Belt Tx (the "Black Belt Tx Loan") in the amount of 211,800 euros (approximately $250,000) with a non-compounding annual interest rate of 6% payable at maturity. The principal balance is also due at maturity. The proceeds will support and advance Black Belt Tx's programs and general operations. The loan principal will be disbursed in three equal installments of 70,600 euros (approximately $83,000). The first tranche was disbursed upon execution of the loan agreement in August 2020. The second and third tranche will be disbursed only under certain operational circumstances and with Black Belt Tx’s Board of Directors' approval. In the event that Black Belt Tx, on or prior to the maturity date, completes an equity financing round of at least 5,000,000 euros (approximately $5.9 million), then the outstanding principal amount shall be automatically converted into such shares at 80% of the price per share issued divided by a compensating factor based on the number of years that the Black Belt Tx Loan has been outstanding. The investment in convertible loan is accounted for as investment in debt securities as available-for-sale instrument. As the Company does not have significant influence over operating and financial policies of Black Belt Tx, and the debt and equity interests do not have readily determinable fair value, the investment in Black Belt Tx is stated at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment. The Company did not record any adjustments or impairments during the three and nine months ended September 30, 2020 related to this investment. Juventas Cell Therapy Limited In June 2019, in conjunction with its license agreement entered into with Juventas (see Note 2), the Company, through CASI Biopharmaceuticals, made an RMB 80 million ($11,788,000) investment in Juventas, a privately held, China-based company, in Juventas’ Series A plus equity, which represented a 16.327% equity interest on a fully diluted basis, and the right to appoint a non-voting board observer. The Company was entitled with substantive liquidation preference over the founding shareholder of Juventas. In addition, the Juventas’ founding shareholder provided a put option to the Company pursuant to which the Company can put the equity investment to the founding shareholder at a fixed return of 8% per annum upon occurrence of certain events. The investment in the equity interests of the Juventas and the investment in put option to the founding shareholder were accounted for as investments in equity securities using the measurement alternative at its cost, minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer, as the fair value of the equity securities of Juventas is not readily determinable. The consideration of RMB 80 million ($11,788,000) was allocated into investment in equity interests and investment in put option based on their relative fair value on the transaction date. In September 2020, in conjunction with the Supplementary Agreement entered into with Juventas (see Note 2), Juventas issued additional Series A plus equity to the Company with substantive liquidation preference over Juventas’ founding shareholder, resulting in the Company’s equity ownership increasing to 19.652% (post-Juventas Series B financing) on a fully diluted basis. CASI Biopharmaceuticals is also entitled to appoint a director to Juventas’ board of directors. Juventas’ founding shareholder also provided a put option to the Company pursuant to which the Company can put the additional equity investment to the founding shareholder at RMB 70 million plus a fixed return of 8% per annum upon occurrence of certain events. The transaction closed on September 29, 2020. The fair value of the Company’s additional equity interest in Juventas and the new put option was RMB 83.7 million ($12.3 million) and RMB 0.4 million ($64,000) on September 29, 2020, respectively. Since the equity interest with substantive liquidation preference is not in-substance common stock, the investment in the additional equity interests of Juventas was accounted for as an investment in equity securities at transaction date fair value with a corresponding credit to Other Liabilities. The profit-sharing liability represents the Company’s obligation to pay an increased share of future profits pursuant to the Supplementary Agreement (see Note 2) which was conveyed by the Company in exchange for the additional equity interests in Juventas. The Company views this as a payment from a vendor that should reduce cost of revenues over the period of royalty payments. The long-term liability will be derecognized as payments are made on a systematic and rational basis representing the pattern in which the Company expects to settle the profit-sharing payment during the commercialization period of CNCT19. The investments are measured using the measurement alternative at its cost, minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer, as the fair value of the equity securities of Juventas is not readily determinable. In addition, the changes in the fair value of the original investment in equity interests and put option in the amount of $1,116,000 resulting from the observable price in this transaction was recognized during the three and nine months ended September 30, 2020. In June 2020, the Company entered into a one-year loan agreement with Juventas in the amount of RMB 30,000,000 (approximately $4,243,000) with an annual interest rate of 20%. In August 2020, the Company entered into another one-year |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2020 | |
Inventories | |
Inventories | 5. Inventories Inventories at September 30, 2020 and December 31, 2019 consisted of the following: (In thousands) September 30, 2020 December 31, 2019 Finished goods $ 720 $ 4,514 Raw materials — 28 Total $ 720 $ 4,542 No provisions to write down the carrying amount of inventory have been recorded in the three and nine months ended September 30, 2020 and 2019. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2020 | |
Leases | |
Leases | 6. Leases Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. Operating lease liabilities (see below) are included in accrued liabilities and other liabilities (noncurrent) in the unaudited condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019. All of the Company’s existing leases as of September 30, 2020 are classified as operating leases. As of September 30, 2020, the Company had seven material operating leases for land, facilities and office equipment with remaining terms expiring from 2021 through 2069 and a weighted average remaining lease term of36.36 years. The Company has fair value renewal options for five of the Company’s existing leases, none of which are considered reasonably certain of being exercised or included in the minimum lease term. Weighted average discount rates used in the calculation of the lease liability is 4.2%. The discount rates reflect the estimated incremental borrowing rate, which includes an assessment of the credit rating to determine the rate that the Company would have to pay to borrow, on a collateralized basis for a similar term, an amount equal to the lease payments in a similar economic environment. In November 2019, CASI Wuxi entered into a fifty-year lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility. The land parcel is 74,028.40 square meters. The Company classifies this lease as an operating lease. The Company prepaid all of the lease payments for the land use right in 2019 in the amount of RMB 45 million (equivalent to US$6.6 million). In April 2020, CASI Wuxi received RMB 15.9 million (equivalent to approximately US$2.2 million) from the Jiangsu Province Wuxi Huishan Economic Development Zone as government grant for this development project which was recorded as deferred income in April 2020 (See Note 9). On August 27, 2020, CASI Wuxi entered into the Construction Project Contract for RMB 74,588,000 (equivalent to approximately $10,923,000) to complete the phase 1 project of CASI Wuxi's research and development production base (see Note 19). The estimated completion date is October 2023. In the third quarter of 2020, the Company entered into two 3-year lease agreements for office space in China each of which continue through August 2023 and September 2023, respectively. The Company recorded right-of-use assets of $1.1 million and related lease liabilities of $1.0 million at lease commencement date. The Company classifies these leases as operating leases. Rent expense for the nine months ended September 30, 2020 and 2019 was approximately $1,153,000 and $957,000, respectively. There were no variable lease costs or sublease income for leased assets for the nine months ended September 30, 2020. Right of use assets and liabilities as of September 30, 2020 and December 31, 2019 in the condensed consolidated balance sheets were as follows: (In thousands) September 30, 2020 December 31, 2019 Right of use assets $ 9,015 $ 8,708 Accrued liabilities $ 1,292 $ 1,182 Other liabilities 1,071 1,019 Total lease liabilities $ 2,363 $ 2,201 Supplemental cash flow information related to leases was as follows: Year ended (In thousands) September 30, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,064 Right of use assets obtained in exchange for lease obligations: $ 1,030 A maturity analysis of our operating leases as of September 30, 2020 follows: Future undiscounted cash flows: (In thousands) 2020 (remaining three months) $ 386 2021 1,360 2022 592 Thereafter 246 Total 2,584 Discount factor (221) Lease liability 2,363 Amounts due within 12 months 1,292 Non-current lease liability $ 1,071 |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2020 | |
Intangible Assets | |
Intangible Assets | 7. Intangible Assets Intangible assets include ANDAs that were acquired as part of 2018 asset acquisitions of US marketed generic products and capitalized costs related to a cloud computing arrangement (CCA). The ANDAs are amortized over their estimated useful lives of 13 years In February 2020, the Company entered into an agreement with Chartwell Rx Sciences, LLC (“Chartwell”) in which the Company sold and transferred the control of seven U.S. FDA-approved ANDAs to Chartwell in exchange for $450,000 in cash, which the Company received in March 2020. These ANDAs had a net book value of $0 at the time of sale. The Company is entitled to an additional $1 million, contingent upon Chartwell receiving certain FDA approvals relating to certain of these ANDAs. The Company recognized a gain on disposal of intangible assets in the amount of $450,000 in the accompanying unaudited condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2020. The additional $1 million is treated as variable consideration. Because the amount of variable consideration is highly susceptible to factors outside the Company's influence and the Company’s experience with similar types of contracts is limited, the Company did not include the amount of variable consideration in recognition of gain on disposal of intangible assets for the nine months ended September 30, 2020. The Company will recognize the variable consideration and additional gain on disposal of intangible assets when the constraint on variable consideration is resolved, i.e., Chartwell receives relevant FDA approvals. Intangible assets at September 30, 2020 consists of the following: (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,963 $ (3,058) 13 years Others 195 (85) 5 years Total $ 16,158 $ (3,143) Expected future amortization expense, is as follows: (In thousands) 2020 (remaining three months) $ 318 2021 1,271 2022 1,271 2023 1,271 2024 1,237 2025 and thereafter 7,647 |
Assets Held for Sale
Assets Held for Sale | 9 Months Ended |
Sep. 30, 2020 | |
Assets Held for Sale | |
Assets Held for Sale | 8. Assets Held for Sale During the nine months ended September 30, 2020, the Company classified 14 ANDAs as assets held for sale as it committed to plans to sell these assets within one year and actively market the assets in their current condition at a price that is reasonable in relation to their estimated fair value. The held for sale criteria were met during the nine months ended September 30, 2020. Assets held for sale are reported at the lower of cost or fair value less costs to sell and are recorded in a single line in the unaudited condensed consolidated balance sheets. The Company recorded an impairment of assets held for sale of $1.5 million in the nine months ended September 30, 2020. The Company reclassified the comparable balance sheet amounts related to these fourteen ANDAs in the amount of approximately $3.2 million as of December 31, 2019 from intangible assets to assets held for sale. In July 2020, the Company entered into an agreement with Rubicon Research Private Limited (“Rubicon”) in which the Company sold and transferred the control of four U.S. FDA-approved ANDAs to Rubicon in exchange for $1.25 million in cash, which the Company received in July 2020. These ANDAs had a net book value of $1.25 million at the time of sale resulting on no gain or loss on the sale. Assets held-for-sale at September 30, 2020 consists of the following: (In thousands) September 30, 2020 December 31, 2019 Cost of intangible assets $ 2,281 $ 4,074 Accumulated amortization (635) (853) Impairment of intangible assets (1,348) — $ 298 $ 3,221 In October 2020, the Company entered into an agreement with Chartwell in which the Company sold and transferred the control of 10 ANDAs to Chartwell in exchange for $1.0 million in cash, which the Company will receive in the fourth quarter of 2020. These ANDAs had a net book value of $0.3 million at the time of sale, resulting in a gain on sale of assets of $0.7 million in the fourth quarter of 2020. |
Grants
Grants | 9 Months Ended |
Sep. 30, 2020 | |
Grants | |
Grants | 9. Grants In November 2019, CASI Wuxi entered into a fifty-year lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility (see Note 6). In November 2019, the Company entered into a grant agreement with the Administrative Committee of Wuxi Huishan Economic Development Zone, under which, the Company is eligible for grants up to RMB 25 million (equivalent to approximately $3.6 million) to support the development of CASI Wuxi’s manufacturing site. In April 2020, CASI Wuxi received RMB 15.9 million (equivalent to approximately $2.2 million) from the Jiangsu Province Wuxi Huishan Economic Development Zone as a government grant for this development project which was recorded as deferred income in April 2020. The grant will be amortized over the term of the lease of the land. The Company recognized $12,000 and $23,000 of other income during the three and nine months ended September 30, 2020, respectively. |
Note Payable
Note Payable | 9 Months Ended |
Sep. 30, 2020 | |
Note Payable | |
Note Payable | 10. Note Payable On April 27, 2020, M&T Bank approved a $465,595 loan to the Company under the Paycheck Protection Program (PPP) pursuant to the Coronavirus Aid, Relief and Economic Security (CARES) Act that was signed into law on March 27, 2020. The loan, evidenced by a promissory note to M&T Bank as lender and dated April 29, 2020, has a term of two years, is unsecured, and is guaranteed by the Small Business Administration (SBA). The loan bears interest at a fixed rate of one percent per annum, with the first six months of interest and principal deferred. Some or all of the loan may be forgiven if the Company complies with certain relevant conditions. Interest expense of approximately $1,200 and $1,900 was recorded in the three and nine months ended September 30, 2020. A maturity analysis of the note payable as of September 30, 2020 follows: Future undiscounted cash flows: (In thousands) 2020 (remaining three months) $ 52 2021 316 2022 104 Thereafter — Total 472 Discount factor (6) Amounts due within 12 months 285 Non-current liability $ 181 |
Redeemable Noncontrolling Inter
Redeemable Noncontrolling Interest | 9 Months Ended |
Sep. 30, 2020 | |
Redeemable Noncontrolling Interest | |
Redeemable Noncontrolling Interest | 11. Redeemable Noncontrolling Interest On December 26, 2018, the Company, together with Wuxi Jintou Huicun Investment Enterprise, a limited partnership organized under Chinese law (“Wuxi LP”) established CASI Wuxi to build and operate a manufacturing facility in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The Company holds 80% of the equity interests in CASI Wuxi and will invest, over time, $80 million in CASI Wuxi. The Company’s investment will consist of (i) $21 million in cash (paid in February 2019), (ii) a transfer of selected ANDAs valued at $30 million (transferred in May 2019), and (iii) an additional $29 million cash payment within three years from the date of establishment of CASI Wuxi. Wuxi LP holds 20% of the equity interest in CASI Wuxi through its investment in RMB of $20 million in cash (paid in March 2019). As the transfer of ANDAs valued at $30 million was to the Company’s consolidated subsidiary (CASI Wuxi), the Company recognized the transfer of the ANDAs at their carrying value and did not recognize a gain on the transfer. The investment of Wuxi LP in CASI Wuxi is treated as redeemable noncontrolling interest and is classified outside of permanent equity on the consolidated balance sheets because (1) the noncontrolling interest is not mandatorily redeemable financial instruments, and (2) it is redeemable at the option of the holder, or upon the occurrence of an event that is not solely within the control of the Company. Accretion of the carrying amount of redeemable noncontrolling interest to the redemption value is recorded in additional paid-in capital. Changes in redeemable noncontrolling interest during the three and nine month periods ended September 30, 2020 and 2019 are as follows: Three Months Ended Nine Months Ended (In thousands) September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 Balance at beginning of period $ 21,074 $ 20,237 $ 20,670 $ — Cash contribution by Wuxi LP — — — 20,000 Share of CASI Wuxi (net loss)/income (309) (23) (584) 53 Accretion of redeemable noncontrolling interest 506 245 1,185 406 Balance at end of period $ 21,271 $ 20,459 $ 21,271 $ 20,459 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity | |
Stockholders' Equity | 12. Stockholders’ Equity July 2020 Underwritten Public Offering On July 24, 2020, the Company closed an underwritten public offering of 23 million shares of common stock (the "Offering") and received gross proceeds of approximately $43.7 million before deducting the underwriting discounts and commissions and offering expenses payable by CASI. Certain insiders, including CASI's Chief Executive Officer, and CASI's President, purchased shares of common stock in the Offering at the public offering price and on the same terms as the other purchasers in this Offering. Common Stock Sales Agreements The Company has a Common Stock Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“HCW”). On July 19, 2019, the Company entered into an amendment to the Sales Agreement reducing the maximum amount that may be sold under the Sales Agreement to $20 million. As of September 30, 2020, approximately $19.5 million remained available under the Sales Agreement. On July 19, 2019, the Company entered into an Open Market Sale Agreement SM For the nine months ended September 30, 2020, there were approximately 434,000 shares issued under the Open Market Agreement with net proceeds of approximately $1,357,000. As of September 30, 2020, the Company has issued approximately 493,000 shares with net proceeds of approximately $1,539,000. As of September 30, 2020, approximately $28.4 million remained available under the Open Market Agreement. Stock purchase warrants activity for the nine months ended September 30, 2020 is as follows: Number of Weighted Average Warrants Exercise Price Outstanding at January 1, 2020 9,843,720 $ 4.43 Issued — $ — Exercised (82,304) $ 1.69 Expired (1,489,707) $ 3.75 Outstanding at September 30, 2020 8,271,709 $ 4.58 Exercisable at September 30, 2020 8,271,709 $ 4.58 All outstanding warrants are equity classified. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2020 | |
Net Loss Per Share | |
Net Loss Per Share | 13. Net Loss Per Share The following table sets forth the basic and diluted net loss per share computation and provides a reconciliation of the numerator and denominator for the periods presented: Three Months Ended Nine Months Ended (In thousands, except per share data) September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (16,953) $ (9,891) $ (34,088) $ (33,539) Denominator: Weighted average number of common shares 117,940 95,891 105,922 95,753 Denominator for basic and diluted net loss per share calculation 117,940 95,891 105,922 95,753 Net loss per share — Basic and diluted $ (0.14) $ (0.10) $ (0.32) $ (0.35) As of September 30, 2020, and 2019, outstanding stock options totaling 15,956,030 and 18,663,581, respectively, and outstanding warrants totaling 8,271,709 and 10,794,172, respectively, were anti-dilutive, and therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Stock-Based Compensation | 14. Stock-Based Compensation As of September 30, 2020, a total of 10,875,131 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan. The Company’s net loss for the nine months ended September 30, 2020 and 2019 includes $5.7 million and $5.3 million, respectively, of non-cash compensation expense related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows: Nine Months Ended September 30, (In thousands) 2020 2019 Research and development $ 123 $ 359 General and administrative 5,562 4,961 Share-based compensation expense $ 5,685 $ 5,320 Compensation expense related to stock options is recognized over the requisite service period, which is generally the option vesting term of up to five years. Awards with performance conditions are expensed when it is probable that the performance condition will be achieved. For the nine month periods ended September 30, 2020 and 2019, approximately $13,000 and $58,000 was expensed for stock option awards with performance conditions that were probable during the period, respectively. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of service based and performance-based stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free interest rate, expected dividend yield, expected volatility, and the expected life of the award. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the nine month periods ended September 30, 2020 and 2019: Nine Months Ended September 30, 2020 2019 Expected volatility 77.71 % 77.36 % Range of expected volatility 75.84% to 81.63 % 75.50% to 84.48 % Range of risk free interest rate 0.31% to 1.77 % 1.62% to 2.59 % Expected term of option 6.03 years 6.05 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the nine month periods ended September 30, 2020 and 2019 were $1.96 and $2.20, respectively. A summary of changes in options under the Company’s stock option plans during the nine month period ended September 30, 2020 is as follows: Weighted Average Number of Options Exercise Price Outstanding at January 1, 2020 18,268,372 $ 2.58 Exercised (2,789,473) $ 1.39 Granted 1,245,686 $ 2.92 Expired (110,430) $ 4.96 Forfeited (658,125) $ 3.89 Outstanding at September 30, 2020 15,956,030 $ 2.75 Vested and expected to vest at September 30, 2020 15,956,030 $ 2.75 Exercisable at September 30, 2020 9,153,348 $ 2.35 Cash received from option exercises under all share-based payment arrangements for the nine month periods ended September 30, 2020 and 2019 was $3.9 million and $114,000, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Taxes | |
Income Taxes | 15. Income Taxes At December 31, 2019, the Company had a $2.6 million unrecognized tax benefit. The Company recorded a full valuation allowance on the deferred tax asset after offsetting unrecognized tax benefit recognized in the consolidated financial statements as of December 31, 2019. During the nine months ended September 30, 2020, there were no material changes to the measurement of unrecognized tax benefits in various tax jurisdictions. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 16. Fair Value Measurements The majority of the Company’s financial instruments (consisting of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and notes payable) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities at fair value, and investment in convertible loan-AFS are carried at fair value (see Note 4). U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: ● Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. ● Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. ● Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. The Company has an equity investment in the common stock of a publicly traded company. The Company’s investment in this equity security is carried at its estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period (see Note 4). The fair value of the common stock is based on quoted market price for the investee’s common stock, a Level 1 input. The following tables present the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of September 30, 2020 and December 31, 2019, by level within the fair value hierarchy: (In thousands) Fair Value at Description September 30, 2020 Level 1 Level 2 Level 3 Investment in common stock $ 1,796 $ 1,796 $ — $ — Investment in convertible loan-AFS $ 83 $ — $ — $ 83 (In thousands) Fair Value at Description December 31, 2019 Level 1 Level 2 Level 3 Investment in common stock $ 625 $ 625 $ — $ — Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company measures equity investments without readily determinable fair values at its cost, minus impairment, if any, plus or minus changes resulting from observable transactions of identical or similar securities of the same issuer. On September 29, 2020, the Company remeasured the investments in equity securities in Juventas (see Note 4) to the fair value. The Company estimated the fair value of these securities based on the transaction price of similar securities issued by the investee adjusted for contractual rights and obligations of the securities it holds. Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis As of June 30, 2020, the intangible assets and assets held for sale with a total carrying amount of $3,087,000 were written down to their fair value of $1,550,000, resulting in an impairment charge of $1,537,000, which represents the difference between the carrying value of the intangible asset and assets held for sale and its fair value. The Company estimated the fair value using Level 2 inputs based on quoted price. Related intangible assets were reclassified as assets held for sale during the quartered ended September 30, 2020. (In thousands) Fair Value at Description December 31, 2019 Level 1 Level 2 Level 3 Long-lived assets $ 287 $ — $ — $ 287 The long-lived assets represent equipment leased to Juventas (Note 17). As of December 31, 2019, equipment leased to Juventas with a total carrying amount of $673,000 were written down to their fair value of $287,000, resulting in an impairment charge of $386,000, representing the difference between total carrying amount and fair value of these long-lived assets, which was calculated based on Level 3 Inputs. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions | |
Related Party Transactions | 17. Related Party Transactions On July 1, 2019 the Company entered into a one-year equipment lease with Juventas in the amount of RMB 80,000 (approximately $15,000) a month, which is classified as an operating lease. Transactions with Juventas are considered to be related party transactions as the Company’s CEO and Chairman is the chairman and one of the founding shareholders of Juventas. In August 2020, the lease was renewed for another year with the same monthly lease income. During the nine months ended September 30, 2020, the Company recognized lease income of $104,000. For license, investment and loan transactions with Juventas please refer to Note 2 and Note 4. In 2018, the Company entered into commercial purchase obligation commitments for EVOMELA from Spectrum Pharmaceuticals, Inc. (“Spectrum”) totaling approximately $9.2 million under a short-term supply agreement for EVOMELA. All of these EVOMELA purchase commitments have been delivered as of October 2019. Spectrum is a greater than a 7.45% shareholder of the Company. There were no transactions with Spectrum during the nine months ended September 30, 2020. For the year ended December 31, 2019, the transactions relating to the manufacturing and purchase of the EVOMELA commercial product supply amounted to $7.8 million. The amount due to Spectrum was $0.2 million as of December 31, 2019. The Company also accrued approximately $2.6 million for material costs related to EVOMELA during the year ended December 31, 2019. As of September 30, 2020, all amounts due to Spectrum have been settled. |
Acrotech License Arrangements
Acrotech License Arrangements | 9 Months Ended |
Sep. 30, 2020 | |
Acrotech License Arrangements | |
Acrotech License Arrangements | 18. Acrotech License Arrangements The Company has certain product rights and perpetual exclusive licenses from Acrotech Biopharma L.L.C. (“Acrotech”) to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”): ● EVOMELA ® (Melphalan Hydrochloride For Injection) ● ZEVALIN ® (Ibritumomab Tiuxetan); and ● MARQIBO ® (Vincristine Sulfate Liposome Injection) CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed. On December 3, 2018 the Company received NMPA’s approval for importation, marketing and sales in China for EVOMELA. The Company has in place an experienced commercial team with a successful track record to execute the commercial sales of EVOMELA that launched in August 2019. The Company has initiated an NMPA required post-marketing study in 2020. On February 12, 2019, the Company received NMPA’s approval of the Company’s clinical trial application (CTA) to conduct a registration trial to evaluate the efficacy and safety of ZEVALIN. The Company expects to initiate a ZEVALIN registration study in China in 2021. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2020 | |
Commitments | |
Commitments | 19. Commitments In conjunction with the Black Belt agreement entered into during 2019 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of September 30, 2020, no milestones have been met. In conjunction with the Pharmathen agreement entered into during 2019 (see Note 2), the Company is responsible for one remaining milestone payment. As of September 30, 2020, the remaining milestone has not been met. In conjunction with the Laurus Labs agreement entered into during 2018 related to the certain ANDAs, the Company is responsible for certain remaining milestone payments. As of September 30, 2020, the remaining milestones have not been met. In November 2019, CASI Wuxi entered into a lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility. Pursuant to the agreement, CASI Wuxi commits to invest land use right and property, plant and equipment of RMB 1 billion (equivalent to US$143 million) within three years from the date of establishment of CASI Wuxi. On August 27, 2020, CASI Wuxi entered into a Construction Project Contract (the "Construction Contract") with China Electronic System Engineering No. 2 Construction Co., Ltd. ("China Engineering"). Pursuant to the Construction Contract, CASI Wuxi will pay a contract price of approximately RMB 74,588,000 (equivalent to approximately USD $10,923,000) to retain China Engineering to complete the phase 1 project of CASI Wuxi's research and development production base, consisting of construction and installation of a combined factory building, warehouse, guard house and public works. The estimated completion date is October 2023. The Company is subject in the normal course of business to various legal proceedings in which claims for monetary or other damages may be asserted. Management does not believe such legal proceedings, unless otherwise disclosed herein, are material. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Event | |
Subsequent Event | 20. Subsequent Event In October 2020, the Company and BioInvent International AB (“BioInvent”) entered into an exclusive licensing agreement for the development and commercialization of novel anti-FcγRIIB antibody, BI-1206, in mainland China, Taiwan, Hong Kong and Macau. BioInvent is a biotechnology company focused on the discovery and development of first-in-class immune-modulatory antibodies for cancer immunotherapy. Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both hematological malignancies and solid tumors, with CASI responsible for commercialization in China and associated markets. BioInvent received a $5 million upfront payment made in November 2020 and is eligible to receive up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206. Under the terms of the Agreement, in addition to the upfront payment, CASI will also make a $7.0 million investment (approximately SEK 61.4 million) in approximately 29.4 million new shares in BioInvent at a subscription price of SEK 2.09 per share, which corresponds to 130% of the average volume weighted price for the share during the ten BI-1206 is a novel mode-of-action, single inhibitory antibody that blocks the FcγRIIB receptor to unlock anti-cancer immunity in both hematological malignancies and solid tumors. BI-1206 is BioInvent’s lead drug candidate and is being investigated in a Phase I/II trial, in combination with anti-PD1 therapy Keytruda ® ® |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Summary of Significant Accounting Policies | |
Revenue Recognition | Revenue Recognition The Company recognizes revenue using the following steps: ● Identification of the contract, or contracts, with a customer; ● Identification of the performance obligations in the contract; ● Determination of the transaction price, including the identification and estimation of variable consideration; ● Allocation of the transaction price to the performance obligations in the contract; and ● Recognition of revenue when we satisfy a performance obligation. The Company recognizes revenue on sales of EVOMELA when the control of the product is transferred to the distributor, which occurs upon delivery of the product to the distributor, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product, excluding amounts collected on behalf of third parties (e.g. value-added taxes). Payment terms for these sales are due within 90 days. The arrangement does not include any variable consideration. The costs of assurance type warranties that provide the customer the right to exchange purchased product that does not meet appropriate quality standards are recognized when they are probable and are reasonably estimable. As of September 30, 2020, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of September 30, 2020. |
Costs of Revenues | Costs of Revenues Cost of revenues consists primary of the cost of inventories of EVOMELA and sales-based royalties related to the sale of EVOMELA. |
Use of Estimates | Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to recoverability of operating lease right-of-use assets, intangible assets and long-term investments, net realizable value and obsolescence allowance for inventory, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments in equity securities in Juventas. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements. |
Accounts Receivable and Credit Concentration | Accounts Receivable and Credit Concentration CRGK is the sole customer for the sale of the Company’s EVOMELA product in China. All consolidated revenue for the three and nine months ended September 30, 2020 were generated from sales to CRGK in China. Accounts receivable consist of CRGK receivables of $4.1 million and $1.3 million as of September 30, 2020 and December 31, 2019, respectively. The Company extends credit to CRGK on an unsecured basis and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable. In establishing the required allowance, management considers the historical losses, customer’s financial condition, the amount of accounts receivables in dispute, the accounts receivables aging and the customer’s payment pattern. The Company determined that no allowance for doubtful accounts was necessary as of September 30, 2020. |
Government Grants | Government Grants Government grants are recognized when there is reasonable assurance that the Company will comply with required conditions and the grants will be received. Government grants related to assets are presented as deferred income that is recognized on a systematic basis over the useful life of the asset. |
New Accounting Pronouncements | New Accounting Pronouncements Recently Adopted Pronouncements In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) . |
Investment in Equity Securiti_2
Investment in Equity Securities, at fair value and long-term investments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Investment in Equity Securities, at fair value and long-term investments | |
Schedule of investment | Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains value Common stock Investment $ — $ 1,796 $ 1,796 |
Schedule of components of long-term investments | (In thousands) September 30, 2020 December 31, 2019 Available-for-sale debt securities: Black Belt Tx Limited - convertible loan $ 83 $ — Equity securities without readily determinable fair value: Black Belt Tx Limited - equity interest 2,250 2,250 Juventas Cell Therapy Limited - equity interest 25,035 11,355 Juventas Cell Therapy Limited - put option 201 433 Total $ 27,569 $ 14,038 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventories | |
Schedule of components of inventories | (In thousands) September 30, 2020 December 31, 2019 Finished goods $ 720 $ 4,514 Raw materials — 28 Total $ 720 $ 4,542 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Leases | |
Schedule of impact of Topic 842 on condensed consolidated balance sheet | (In thousands) September 30, 2020 December 31, 2019 Right of use assets $ 9,015 $ 8,708 Accrued liabilities $ 1,292 $ 1,182 Other liabilities 1,071 1,019 Total lease liabilities $ 2,363 $ 2,201 |
Schedule of supplemental cash flow information | Year ended (In thousands) September 30, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,064 Right of use assets obtained in exchange for lease obligations: $ 1,030 |
Schedule of future minimum rental payments for operating leases | (In thousands) 2020 (remaining three months) $ 386 2021 1,360 2022 592 Thereafter 246 Total 2,584 Discount factor (221) Lease liability 2,363 Amounts due within 12 months 1,292 Non-current lease liability $ 1,071 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Intangible Assets | |
Schedule of net definite-lived intangible assets | (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,963 $ (3,058) 13 years Others 195 (85) 5 years Total $ 16,158 $ (3,143) |
Schedule of expected future amortization expense | (In thousands) 2020 (remaining three months) $ 318 2021 1,271 2022 1,271 2023 1,271 2024 1,237 2025 and thereafter 7,647 |
Assets Held for Sale (Tables)
Assets Held for Sale (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Assets Held for Sale | |
Schedule of components of assets held-for-sale | (In thousands) September 30, 2020 December 31, 2019 Cost of intangible assets $ 2,281 $ 4,074 Accumulated amortization (635) (853) Impairment of intangible assets (1,348) — $ 298 $ 3,221 |
Note Payable (Tables)
Note Payable (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Note Payable | |
Schedule of maturity analysis of the notes payable | (In thousands) 2020 (remaining three months) $ 52 2021 316 2022 104 Thereafter — Total 472 Discount factor (6) Amounts due within 12 months 285 Non-current liability $ 181 |
Redeemable Noncontrolling Int_2
Redeemable Noncontrolling Interest (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Redeemable Noncontrolling Interest | |
Schedule of changes in redeemable noncontrolling interest | Three Months Ended Nine Months Ended (In thousands) September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 Balance at beginning of period $ 21,074 $ 20,237 $ 20,670 $ — Cash contribution by Wuxi LP — — — 20,000 Share of CASI Wuxi (net loss)/income (309) (23) (584) 53 Accretion of redeemable noncontrolling interest 506 245 1,185 406 Balance at end of period $ 21,271 $ 20,459 $ 21,271 $ 20,459 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity | |
Schedule of stock purchase warrants activity | Number of Weighted Average Warrants Exercise Price Outstanding at January 1, 2020 9,843,720 $ 4.43 Issued — $ — Exercised (82,304) $ 1.69 Expired (1,489,707) $ 3.75 Outstanding at September 30, 2020 8,271,709 $ 4.58 Exercisable at September 30, 2020 8,271,709 $ 4.58 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share | Three Months Ended Nine Months Ended (In thousands, except per share data) September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (16,953) $ (9,891) $ (34,088) $ (33,539) Denominator: Weighted average number of common shares 117,940 95,891 105,922 95,753 Denominator for basic and diluted net loss per share calculation 117,940 95,891 105,922 95,753 Net loss per share — Basic and diluted $ (0.14) $ (0.10) $ (0.32) $ (0.35) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Schedule of compensation expense | Nine Months Ended September 30, (In thousands) 2020 2019 Research and development $ 123 $ 359 General and administrative 5,562 4,961 Share-based compensation expense $ 5,685 $ 5,320 |
Schedule of weighted-average assumptions used in valuing the stock options | Nine Months Ended September 30, 2020 2019 Expected volatility 77.71 % 77.36 % Range of expected volatility 75.84% to 81.63 % 75.50% to 84.48 % Range of risk free interest rate 0.31% to 1.77 % 1.62% to 2.59 % Expected term of option 6.03 years 6.05 years Expected dividend yield 0.00 % 0.00 % |
Schedule of stock option plans and of changes in options outstanding under the plans | Weighted Average Number of Options Exercise Price Outstanding at January 1, 2020 18,268,372 $ 2.58 Exercised (2,789,473) $ 1.39 Granted 1,245,686 $ 2.92 Expired (110,430) $ 4.96 Forfeited (658,125) $ 3.89 Outstanding at September 30, 2020 15,956,030 $ 2.75 Vested and expected to vest at September 30, 2020 15,956,030 $ 2.75 Exercisable at September 30, 2020 9,153,348 $ 2.35 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured at fair value on recurring and nonrecurring basis | The following tables present the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of September 30, 2020 and December 31, 2019, by level within the fair value hierarchy: (In thousands) Fair Value at Description September 30, 2020 Level 1 Level 2 Level 3 Investment in common stock $ 1,796 $ 1,796 $ — $ — Investment in convertible loan-AFS $ 83 $ — $ — $ 83 (In thousands) Fair Value at Description December 31, 2019 Level 1 Level 2 Level 3 Investment in common stock $ 625 $ 625 $ — $ — (In thousands) Fair Value at Description December 31, 2019 Level 1 Level 2 Level 3 Long-lived assets $ 287 $ — $ — $ 287 |
Basis of Presentation (Details)
Basis of Presentation (Details) - USD ($) $ in Thousands, shares in Millions | Jul. 24, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Description of Business and Basis of Presentation [Line Items] | |||
Retained Earnings (Accumulated Deficit) | $ (556,811) | $ (523,908) | |
Percentage Of Ownership Interest In Non Stock Subsidiary | 100.00% | ||
Shares issued under the offering | 23 | ||
Gross proceeds from the offering | $ 43,700 | ||
CASI China [Member] | |||
Description of Business and Basis of Presentation [Line Items] | |||
Cash | $ 4,200 | ||
CASI Wuxi [Member] | |||
Description of Business and Basis of Presentation [Line Items] | |||
Percentage Of Ownership Interest In Non Stock Subsidiary | 80.00% | ||
Cash | $ 20,400 |
License and Distribution Agre_2
License and Distribution Agreements (Details) $ in Thousands, ¥ in Millions | Oct. 30, 2019 | Oct. 29, 2019EUR (€) | Sep. 30, 2020USD ($) | Sep. 30, 2020CNY (¥) | Apr. 30, 2019EUR (€) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2020EUR (€) | Sep. 30, 2019USD ($) | Dec. 31, 2019EUR (€) |
License and Distribution Agreements | |||||||||||
Revenues | $ | $ 4,242 | $ 2,787 | $ 10,319 | $ 2,787 | |||||||
Pharmathen Global BV [Member] | |||||||||||
License and Distribution Agreements | |||||||||||
Non Royalty Exclusive Distribution Period | 10 years | ||||||||||
Non Royalty Exclusive Distribution, Supply Cost Determination, Period Considered | 3 years | ||||||||||
Pharmathen Global BV [Member] | Maximum | |||||||||||
License and Distribution Agreements | |||||||||||
Additional milestone payments | € 2,000,000 | ||||||||||
Black Belt Therapeutics Limited [Member] | |||||||||||
License and Distribution Agreements | |||||||||||
Upfront payment | € 5,000,000 | ||||||||||
Juventas Cell Therapy Ltd [Member] | |||||||||||
License and Distribution Agreements | |||||||||||
Milestone payment | $ 10,000 | ¥ 70 | |||||||||
EVOMELA [Member] | |||||||||||
License and Distribution Agreements | |||||||||||
Revenues | $ | $ 4,200 | 10,200 | |||||||||
License Agreement Terms [Member] | Pharmathen Global BV [Member] | |||||||||||
License and Distribution Agreements | |||||||||||
Upfront payment | € 1,000,000 | ||||||||||
Acquired in-process research and development expenses | $ 1,700 | € 1,500,000 | |||||||||
Minimum equity financing | 500,000 | ||||||||||
License Agreement Terms [Member] | Pharmathen Global BV [Member] | Research and Development Expense [Member] | |||||||||||
License and Distribution Agreements | |||||||||||
Milestone Payable | € 1,000,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - CRGK [Member] - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Accounts receivable | $ 4,100 | $ 1,300 |
Accounts Receivable, Allowance for Credit Loss | $ 0 |
Investment in Equity Securiti_3
Investment in Equity Securities, at fair value and long-term investments - Summary of Investment (Details) - Common Stock [Member] $ in Thousands | Sep. 30, 2020USD ($) |
Gross unrealized gains equity securities at fair value | $ 1,796 |
Aggregate equity securities at fair value | $ 1,796 |
Investment in Equity Securiti_4
Investment in Equity Securities, at fair value and long-term investments - Summary of Long-term investment (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Schedule Of Long Term Investments [Line Items] | ||
Total | $ 27,569 | $ 14,038 |
Black Belt TX Limited [Member] | Equity Securities [Member] | ||
Schedule Of Long Term Investments [Line Items] | ||
Available-for-sale debt securities - Convertible loan | 83 | |
Equity securities without readily determinable fair value: | 2,250 | 2,250 |
Juventas Cell Therapy Ltd [Member] | Equity Securities [Member] | ||
Schedule Of Long Term Investments [Line Items] | ||
Equity securities without readily determinable fair value: | 25,035 | 11,355 |
Juventas Cell Therapy Ltd [Member] | Put option | ||
Schedule Of Long Term Investments [Line Items] | ||
Equity securities without readily determinable fair value: | $ 201 | $ 433 |
Investment in Equity Securiti_5
Investment in Equity Securities, at fair value and long-term investments - Additional Information (Details) | Sep. 29, 2020USD ($) | Sep. 29, 2020CNY (¥) | Sep. 30, 2020 | Aug. 31, 2020USD ($) | Aug. 31, 2020CNY (¥) | Jul. 31, 2020EUR (€) | Jul. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2020CNY (¥) | Jun. 30, 2019USD ($) | Jun. 30, 2019CNY (¥) | Apr. 30, 2019EUR (€) | Apr. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 29, 2020CNY (¥) | Jul. 31, 2020USD ($) |
Change in fair value of investment in equity securities and long-term investments | $ 862,000 | $ (160,000) | $ 1,171,000 | $ (355,000) | |||||||||||||||
Juventas Cell Therapy Ltd [Member] | |||||||||||||||||||
Change in fair value of investment in equity securities and long-term investments | $ (1,116,000) | $ (1,116,000) | |||||||||||||||||
Payments to acquire Equity Investments | $ 11,788,000 | ¥ 80,000,000 | |||||||||||||||||
Loans Advanced To Related Party, Term | 1 year | 1 year | 1 year | 1 year | |||||||||||||||
Equity ownership (as a percent) | 19.652% | 20.00% | 20.00% | 16.327% | 16.327% | 19.652% | 19.652% | ||||||||||||
Interest rate (as a percent) | 8.00% | 20.00% | 20.00% | 8.00% | 8.00% | ||||||||||||||
Additional equity investment | ¥ | ¥ 70,000,000 | ||||||||||||||||||
Fair value of additional equity interest | $ 12,300,000 | ¥ 83,700,000 | |||||||||||||||||
Loans Advanced To Related Party | $ 5,790,000 | ¥ 40,000,000 | $ 4,243,000 | ¥ 30,000,000 | |||||||||||||||
Interest Income, Related Party | $ 351,000 | $ 375,000 | |||||||||||||||||
Juventas Cell Therapy Ltd [Member] | Put option | |||||||||||||||||||
Payments to acquire Equity Investments | $ 64,000 | ¥ 400,000 | |||||||||||||||||
Black Belt TX Limited [Member] | |||||||||||||||||||
Payments to acquire Equity Investments | € 2,000,000 | $ 2,249,600 | |||||||||||||||||
Amount of equal installments | € 70,600 | $ 83,000 | |||||||||||||||||
Minimum Equity Financing Trigger | € 5,000,000 | $ 5,900,000 | |||||||||||||||||
Percentage of price per share issued at which the outstanding principal loan is to be converted | 80.00% | 80.00% | |||||||||||||||||
Equity ownership (as a percent) | 14.10% | 14.10% | |||||||||||||||||
Interest rate (as a percent) | 6.00% | 6.00% | |||||||||||||||||
Loan to be advanced | € 211,800 | $ 250,000 |
Investment in Equity Securiti_6
Investment in Equity Securities, at fair value and long-term investments (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Change in fair value of investment in equity securities | $ (862,000) | $ 160,000 | $ (1,171,000) | $ 355,000 | |
Level 1 | |||||
Equity Investments, Fair Value Disclosure | $ 1,800,000 | $ 1,800,000 | $ 600,000 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Inventories | |||||
Finished goods | $ 720 | $ 720 | $ 4,514 | ||
Raw materials | 28 | ||||
Inventory, Net, Total | 720 | 720 | $ 4,542 | ||
Write down of obsolete inventories | $ 0 | $ 0 | $ 0 | $ 0 |
Leases - Impact of Topic 842 (D
Leases - Impact of Topic 842 (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Right of use assets | $ 9,015 | $ 8,708 |
Operating Lease, Liability | 2,363 | 2,201 |
Accrued liabilities | ||
Operating Lease, Liability | 1,292 | 1,182 |
Other liabilities | ||
Operating Lease, Liability | $ 1,071 | $ 1,019 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows | $ 1,064 |
Right of use assets obtained in exchange for lease obligations: | $ 1,030 |
Leases - Future Undiscounted Ca
Leases - Future Undiscounted Cash Flows (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Leases | ||
2020 (remaining three months) | $ 386 | |
2021 | 1,360 | |
2022 | 592 | |
Thereafter | 246 | |
Total | 2,584 | |
Discount factor | (221) | |
Lease liability | 2,363 | $ 2,201 |
Amounts due within 12 months | 1,292 | |
Non-current lease liability | $ 1,071 |
Leases - Additional Information
Leases - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Apr. 30, 2020USD ($) | Apr. 30, 2020CNY (¥) | Nov. 30, 2019USD ($)m² | Nov. 30, 2019CNY (¥)m² | Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Aug. 27, 2020USD ($) | Aug. 27, 2020CNY (¥) | Dec. 31, 2019USD ($) | |
Weighted average remaining lease term | 36 years 4 months 9 days | 36 years 4 months 9 days | ||||||||
Weighted average discount rates | 4.20% | 4.20% | ||||||||
Rent expenses | $ 1,153,000 | $ 957,000 | ||||||||
Right of use assets | $ 9,015,000 | 9,015,000 | $ 8,708,000 | |||||||
Lease liability | $ 2,363,000 | 2,363,000 | $ 2,201,000 | |||||||
CHINA | ||||||||||
Number of lease agreements | 2 | |||||||||
Right of use assets | $ 1,100,000 | 1,100,000 | ||||||||
Lease liability | $ 1,000,000 | $ 1,000,000 | ||||||||
Term of the lease contract | 3 years | 3 years | ||||||||
CASI Wuxi [Member] | ||||||||||
Construction project contract amount | $ 10,923,000 | ¥ 74,588,000 | ||||||||
Term of the lease contract | 50 years | 50 years | ||||||||
Land parcel area (in square meters) | m² | 74,028.40 | 74,028.40 | ||||||||
Prepaid lease payments for the land use right | $ 6,600,000 | ¥ 45,000,000 | ||||||||
Government grant received | $ 2,200,000 | ¥ 15,900,000 |
Intangible Assets - Net Definit
Intangible Assets - Net Definite-lived Intangible Assets (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
Purchase Price | $ 16,158 |
Accumulated Amortization | (3,143) |
ANDA | |
Finite-Lived Intangible Assets [Line Items] | |
Purchase Price | 15,963 |
Accumulated Amortization | $ (3,058) |
Estimated useful lives | 13 years |
Others | |
Finite-Lived Intangible Assets [Line Items] | |
Purchase Price | $ 195 |
Accumulated Amortization | $ (85) |
Estimated useful lives | 5 years |
Intangible Assets - Expected Fu
Intangible Assets - Expected Future Amortization Expense (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Intangible Assets | |
2020 (remaining three months) | $ 318 |
2021 | 1,271 |
2022 | 1,271 |
2023 | 1,271 |
2024 | 1,237 |
2025 and thereafter | $ 7,647 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Feb. 29, 2020USD ($)item | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |||||
(Gain) loss on disposal of intangible assets | $ 0 | $ 0 | $ (450,000) | $ 48,000 | |
ANDA | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Estimated useful lives | 13 years | ||||
Cloud Computing Arrangement | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Estimated useful lives | 5 years | ||||
Chartwell | ANDA | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Number of intangible assets sold during the period. | item | 7 | ||||
Aggregate consideration on sale of intangible assets | $ 450,000 | ||||
Net book value | 0 | ||||
Remaining consideration on sale of intangible assets | $ 1,000,000 |
Assets Held for Sale - Componen
Assets Held for Sale - Components of assets held-for-sale (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Assets Held For Sale, Disclosure [Line Items] | ||
Cost of intangible assets | $ 16,158 | |
Accumulated amortization | 3,143 | |
Asset held for sale | ANDA | ||
Assets Held For Sale, Disclosure [Line Items] | ||
Cost of intangible assets | 2,281 | $ 4,074 |
Accumulated amortization | (635) | (853) |
Impairment of intangible assets | (1,348) | 0 |
Total | $ 298 | $ 3,221 |
Assets Held for Sale - Addition
Assets Held for Sale - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jul. 31, 2020USD ($)item | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($)item | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)item | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | |
Assets Held For Sale, Disclosure [Line Items] | ||||||||
Impairment of assets held for sale | $ 1,537,000 | |||||||
(Gain) loss on disposal of intangible assets | $ 0 | $ 0 | $ 450,000 | $ (48,000) | ||||
Proceeds from Sale of Intangible Assets | 1,700,000 | $ 0 | ||||||
ANDA | ||||||||
Assets Held For Sale, Disclosure [Line Items] | ||||||||
Impairment of assets held for sale | $ 1,500,000 | |||||||
Number of intangible assets classified as held for sale | item | 14 | |||||||
Net book value | $ 1,250,000 | $ 3,200,000 | ||||||
(Gain) loss on disposal of intangible assets | $ 0 | |||||||
Number Of Intangible Assets Sold | item | 4 | |||||||
Proceeds from Sale of Intangible Assets | $ 1,250,000 | |||||||
ANDA | Subsequent Events | ||||||||
Assets Held For Sale, Disclosure [Line Items] | ||||||||
Net book value | $ 300,000 | |||||||
(Gain) loss on disposal of intangible assets | $ 700,000 | |||||||
Number Of Intangible Assets Sold | item | 10 | |||||||
Proceeds from Sale of Intangible Assets | $ 1,000,000 |
Grants (Details)
Grants (Details) ¥ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Apr. 30, 2020CNY (¥) | Apr. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Nov. 30, 2019CNY (¥) | Nov. 30, 2019USD ($) | |
Grants, Disclosure [Line Items] | ||||||
Other income | $ 12,000 | $ 23,000 | ||||
CASI Wuxi [Member] | ||||||
Grants, Disclosure [Line Items] | ||||||
Lessor, Operating Lease, Term of Contract | 50 years | 50 years | ||||
Proceeds from Government Grant | ¥ 15.9 | $ 2,200,000 | ||||
Maximum | CASI Wuxi [Member] | ||||||
Grants, Disclosure [Line Items] | ||||||
Amount of grants eligible | ¥ 25 | $ 3,600,000 |
Note Payable (Details)
Note Payable (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Maturity analysis of the note payable | |
2020 (remaining three months) | $ 52 |
2021 | 316 |
2022 | 104 |
Thereafter | 0 |
Total | 472 |
Discount factor | (6) |
Amounts due within 12 months | 285 |
Non-current liability | $ 181 |
Note Payable - Additional Infor
Note Payable - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2020 | Apr. 27, 2020 | |
Note Payable | |||
Line of Credit Facility, Maximum Borrowing Capacity | $ 465,595 | ||
Interest expense | $ 1,200 | $ 1,900 |
Redeemable Noncontrolling Int_3
Redeemable Noncontrolling Interest - Changes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Redeemable Noncontrolling Interest | ||||
Balance at beginning of period | $ 21,074 | $ 20,237 | $ 20,670 | |
Cash contribution by Wuxi LP | 0 | 0 | 0 | $ 20,000 |
Share of CASI Wuxi (net loss)/income | (309) | (23) | (584) | 53 |
Accretion of redeemable noncontrolling interest | 506 | 245 | 1,185 | 406 |
Balance at end of period | $ 21,271 | $ 20,459 | $ 21,271 | $ 20,459 |
Redeemable Noncontrolling Int_4
Redeemable Noncontrolling Interest - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
May 31, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Feb. 28, 2019 | Dec. 26, 2018 | |
Noncontrolling Interest [Line Items] | |||||
Value of transfer of selected ANDAs | $ 30 | ||||
CASI Wuxi [Member] | |||||
Noncontrolling Interest [Line Items] | |||||
Equity Method Investment, Ownership Percentage | 80.00% | ||||
Investment Commitment | $ 80 | ||||
Initial Cash Investment | $ 21 | ||||
Value of transfer of selected ANDAs | $ 30 | ||||
Payments To Be Paid Within Three Years | $ 29 | ||||
Payments to Acquire Investments | $ 20 | ||||
CASI Wuxi [Member] | Call Option [Member] | |||||
Noncontrolling Interest [Line Items] | |||||
Equity Method Investment, Ownership Percentage | 20.00% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Stockholders' Equity | |
Outstanding at Number of Warrants, Beginning Balance | shares | 9,843,720 |
Issued Number of Warrants | shares | 0 |
Exercised Number of Warrants | shares | (82,304) |
Expired Number of Warrants | shares | (1,489,707) |
Outstanding at Number of Warrants, Ending Balance | shares | 8,271,709 |
Exercisable Number of Warrants | shares | 8,271,709 |
Outstanding Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 4.43 |
Issued Weighted Average Exercise Price | $ / shares | 0 |
Exercised Weighted Average Exercise Price | $ / shares | 1.69 |
Expired Weighted Average Exercise Price | $ / shares | 3.75 |
Outstanding Weighted Average Exercise Price, at Ending Balance | $ / shares | 4.58 |
Exercisable Weighted Average Exercise Price | $ / shares | $ 4.58 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Jul. 24, 2020 | Jul. 19, 2019 | Sep. 30, 2020 | Dec. 31, 2019 |
Stock Issued During Period, Shares, New Issues | 23,000,000 | |||
Common Stock, Shares Issued (in shares) | 124,023,374 | 97,851,243 | ||
Net Proceeds From Issuance Of Common Stock | $ 1,539,000 | |||
Remaining Dollar Amount Available Under Sales Agreement | $ 19,500,000 | |||
Proceeds from Issuance of Common Stock | $ 43,700,000 | |||
Amendment To Open Sale Agreement [Member] | ||||
Maximum Sales Price from Issuance of Common Stock | $ 20,000,000 | |||
Open Market Sale Agreement [Member] | ||||
Stock Issued During Period, Shares, New Issues | 434,000 | |||
Common Stock, Shares Issued (in shares) | 493,000 | |||
Net Proceeds From Issuance Of Common Stock | $ 1,357,000 | |||
Remaining Dollar Amount Available Under Open Market Agreement | $ 28,400,000 | |||
Maximum Sales Price from Issuance of Common Stock | $ 30,000,000 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | Sep. 30, 2020 | Sep. 30, 2019 |
Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 15,956,030 | 18,663,581 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 8,271,709 | 10,794,172 |
Net Loss Per Share - Basic and
Net Loss Per Share - Basic and diluted net loss per share computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Numerator: | ||||
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (16,953) | $ (9,891) | $ (34,088) | $ (33,539) |
Denominator: | ||||
Weighted average number of common shares | 117,940 | 95,891 | 105,922 | 95,753 |
Denominator for basic and diluted net loss per share calculation | 117,940 | 95,891 | 105,922 | 95,753 |
Net loss per share - Basic and diluted (in dollars per share) | $ (0.14) | $ (0.10) | $ (0.32) | $ (0.35) |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 5,685 | $ 5,320 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 123 | 359 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 5,562 | $ 4,961 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted-Average Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Stock-Based Compensation | ||
Expected volatility | 77.71% | 77.36% |
Range of expected volatility, Minimum | 75.84% | 75.50% |
Range of expected volatility, Maximum | 81.63% | 84.48% |
Range of risk free interest rate, Minimum | 0.31% | 1.62% |
Range of risk free interest rate, Maximum | 1.77% | 2.59% |
Expected term of option | 6 years 10 days | 6 years 18 days |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Outstanding (Details) - $ / shares | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Outstanding - Number of Options, Beginning Balance | 18,268,372 |
Exercised - Number of Options | (2,789,473) |
Granted - Number of Options | 1,245,686 |
Expired - Number of Options | (110,430) |
Forfeited - Number of Options | (658,125) |
Outstanding - Number of Options, Ending Balance | 15,956,030 |
Vested and expected to vest - Number of options | 15,956,030 |
Exercisable - Number of Options | 9,153,348 |
Outstanding - Weighted Average Exercise Price, Beginning balance | $ 2.58 |
Exercised - Weighted Average Exercise Price | 1.39 |
Granted - Weighted Average Exercise Price | 2.92 |
Expired - Weighted Average Exercise Price | 4.96 |
Forfeited - Weighted Average Exercise Price | 3.89 |
Outstanding - Weighted Average Exercise Price, Ending Balance | 2.75 |
Vested and expected to vest - Weighted Average Exercise Price | 2.75 |
Exercisable - Weighted Average Exercise Price | $ 2.35 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation | $ 5,685,000 | $ 5,320,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.96 | $ 2.20 |
Performance Share Based Compensation Expense | $ 13,000 | $ 58,000 |
Share Based Payment Cash Received from Stock Option Exercises | $ 3,900,000 | $ 114,000 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Expire Terms | 5 years | |
Long Term Incentive Plan2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 10,875,131 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | Sep. 30, 2020 | Dec. 31, 2019 |
Income Taxes | ||
Unrecognized Tax Benefits | $ 0 | $ 2.6 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Sep. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-lived assets | $ 1,550,000 | ||
Fair Value, Recurring [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Investment in common stock | $ 1,796,000 | $ 625,000 | |
Investments, Fair Value Disclosure, Covertible Loan | 83,000 | ||
Non-recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-lived assets | 287,000 | ||
Level 1 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Investment in common stock | 625,000 | ||
Level 1 | Fair Value, Recurring [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Investment in common stock | 1,796,000 | ||
Investments, Fair Value Disclosure, Covertible Loan | 0 | ||
Level 1 | Non-recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-lived assets | 0 | ||
Level 2 | Fair Value, Recurring [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Investments, Fair Value Disclosure, Covertible Loan | 0 | ||
Level 2 | Non-recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-lived assets | 0 | ||
Level 3 | Fair Value, Recurring [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Investments, Fair Value Disclosure, Covertible Loan | $ 83,000 | ||
Level 3 | Non-recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-lived assets | $ 287,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Intangible assets and Assets held for sale, total carrying amount | $ 3,087,000 | |
Impairment of intangible assets and assets held for sale | 1,537,000 | |
Intangible assets and assets held for sale | $ 1,550,000 | |
Impairment of equipment | $ 386,000 | |
Equipment leased to Juventas [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying amount | 673,000 | |
Non-recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Intangible assets and assets held for sale | $ 287,000 |
Related Party Transactions (Det
Related Party Transactions (Details) | Jul. 01, 2019USD ($) | Jul. 01, 2019CNY (¥) | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Related Party Transaction [Line Items] | |||||
Inventory, Net | $ 720,000 | $ 4,542,000 | |||
Spectrum [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accounts Payable, Related Parties, Current | 200,000 | ||||
Amount of Expense Incurred | 2,600,000 | ||||
Spectrum [Member] | EVOMELA [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction, Purchase Obligation Commitments | $ 9,200,000 | ||||
Related Party Transaction, Purchases from Related Party | $ 7,800,000 | ||||
Juventas Cell Therapy Ltd [Member] | |||||
Related Party Transaction [Line Items] | |||||
Lessor, Operating Lease, Term of Contract | 1 year | 1 year | |||
Operating Lease, Lease Income, Lease Payments | $ 15,000 | ¥ 80,000 | |||
Operating Lease, Lease Income | $ 104,000 |
Commitments (Details)
Commitments (Details) - CASI Wuxi [Member] | 1 Months Ended | |||
Nov. 30, 2019CNY (¥) | Nov. 30, 2019USD ($) | Aug. 27, 2020CNY (¥) | Aug. 27, 2020USD ($) | |
Land use right and property, plant and equipment, commitment amount | ¥ 1,000,000,000 | $ 143,000,000 | ||
Estimated construction period | 3 years | 3 years | ||
Construction project contract amount | ¥ 74,588,000 | $ 10,923,000 |
Subsequent Event (Details)
Subsequent Event (Details) - 1 months ended Oct. 31, 2020 - Subsequent Events kr / shares in Units, shares in Millions, kr in Millions, $ in Millions | USD ($)shares | USD ($)kr / shares | SEK (kr) |
Subsequent Event [Line Items] | |||
Investment to be made | $ 7 | $ 7 | kr 61.4 |
Subscription price per share (in SEK per share) | kr / shares | $ 2.09 | ||
Percentage of average volume weighted price | 130.00% | ||
Number of trading days | 10 days | ||
Number of new warrants subscribed | shares | 14.7 | ||
Subscription period for warrants | 5 years | ||
Subscription price per warrant (in SEK per share) | kr / shares | $ 3.14 | ||
Maximum | |||
Subsequent Event [Line Items] | |||
Number of shares subscribed (in shares) | shares | 29.4 | ||
BioInvent International AB | |||
Subsequent Event [Line Items] | |||
Upfront payment | $ | $ 5 | ||
Development and commercial milestone payments payable | $ | $ 83 | $ 83 |