Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 18, 2022 | Jun. 30, 2021 | |
Cover | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
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 | ||
Entity Address, Address Line Two | 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, $0.01 par value | ||
Trading Symbol | CASI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000895051 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Public Float | $ 179,150,437 | ||
Entity Common Stock, Shares Outstanding | 136,589,826 | ||
Auditor Firm ID | 1186 | ||
Auditor Name | KPMG Huazhen LLP | ||
Auditor Location | Beijing, China |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 38,704 | $ 57,064 |
Investment in equity securities, at fair value | 9,868 | 9,309 |
Accounts receivable, net of $0 allowance for doubtful accounts | 9,803 | 4,645 |
Inventories | 1,907 | 1,356 |
Prepaid expenses and other | 1,688 | 1,651 |
Total current assets | 61,970 | 74,025 |
Property, plant and equipment, net | 12,712 | 2,062 |
Intangible assets, net | 12,203 | 13,210 |
Long-term investments | 40,128 | 29,442 |
Right of use assets | 9,107 | 8,696 |
Other assets | 2,178 | 299 |
Total assets | 138,298 | 127,734 |
Current liabilities: | ||
Accounts payable | 4,789 | 3,260 |
Accrued and other current liabilities | 8,397 | 3,424 |
Bank borrowings | 826 | |
Notes payable | 466 | |
Total current liabilities | 13,186 | 7,976 |
Deferred income | 2,828 | 2,351 |
Other liabilities | 14,325 | 13,834 |
Total liabilities | 30,339 | 24,161 |
Commitments and contingencies (Note 21) | ||
Redeemable noncontrolling interest, at redemption value (Note 12) | 23,457 | 22,033 |
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 December 31, 2021 and December 31, 2020 139,877,032 shares and 124,023,374 shares issued at December 31, 2021 and December 31, 2020, respectively; 139,797,487 shares and 123,943,829 shares outstanding at December 31, 2021 and December 31, 2020, respectively | 1,399 | 1,240 |
Additional paid-in capital | 694,826 | 658,246 |
Treasury stock, at cost: 79,545 shares held at December 31, 2021 and December 31, 2020 | (8,034) | (8,034) |
Accumulated other comprehensive income | 1,954 | 589 |
Accumulated deficit | (605,643) | (570,501) |
Total stockholders' equity | 84,502 | 81,540 |
Total liabilities, redeemable noncontrolling interest and stockholders' equity | $ 138,298 | $ 127,734 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
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) | 139,877,032 | 124,023,374 |
Common Stock, Shares Outstanding (in shares) | 139,797,487 | 123,943,829 |
Treasury stock, Shares Held (in shares) | 79,545 | 79,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | ||
Product sales | $ 30,020,000 | $ 15,001,000 |
Lease income from a related party | 148,000 | 140,000 |
Total revenues | 30,168,000 | 15,141,000 |
Costs of revenues: | ||
Cost of goods sold | 6,616,000 | 6,553,000 |
Royalty fee | 5,941,000 | 2,955,000 |
Total costs of revenues | 12,557,000 | 9,508,000 |
Gross profit | 17,611,000 | 5,633,000 |
Operating expenses: | ||
Research and development | 14,422,000 | 11,470,000 |
General and administrative | 23,766,000 | 19,661,000 |
Selling and marketing | 14,705,000 | 7,815,000 |
Gain on disposal of intangible assets | (1,152,000) | |
Impairment of intangible assets | 1,537,000 | |
Acquired in-process research and development | 6,555,000 | 17,828,000 |
Total operating expenses | 59,448,000 | 57,159,000 |
Loss from operations | (41,837,000) | (51,526,000) |
Non-operating income/(expense): | ||
Interest income, net | 321,000 | 866,000 |
Other income | 558,000 | 82,000 |
Foreign exchange gains (losses) | 321,000 | (1,255,000) |
Change in fair value of investments | 5,660,000 | 4,322,000 |
Impairment loss of long-term investments | (865,000) | |
Loss before income tax expense | (35,842,000) | (47,511,000) |
Income tax expense | 0 | 0 |
Net loss | (35,842,000) | (47,511,000) |
Less: loss attributable to redeemable noncontrolling interest | (700,000) | (918,000) |
Accretion to redeemable noncontrolling interest redemption value | 1,512,000 | 1,694,000 |
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (36,654,000) | $ (48,287,000) |
Net loss per share (basic) | $ (0.27) | $ (0.44) |
Net loss per share (diluted) | $ (0.27) | $ (0.44) |
Weighted average number of common shares (basic) | 136,105,539 | 110,452,288 |
Weighted average number of common shares (diluted) | 136,105,539 | 110,452,288 |
Comprehensive loss: | ||
Net loss | $ (35,842,000) | $ (47,511,000) |
Foreign currency translation adjustment | 1,977,000 | 3,904,000 |
Total comprehensive loss | (33,865,000) | (43,607,000) |
Less: Comprehensive loss attributable to redeemable noncontrolling interest | (88,000) | (331,000) |
Comprehensive loss attributable to common stockholders | $ (33,777,000) | $ (43,276,000) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
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 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 pursuant to financing agreements | $ 0 | $ 234 | 44,865 | 0 | 0 | 0 | 45,099 |
Issuance of common stock pursuant to financing agreements (in shares) | 0 | 23,434,336 | |||||
Stock issuance costs | $ 0 | $ 0 | (3,028) | 0 | 0 | 0 | (3,028) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 7,821 | 0 | 0 | 0 | 7,821 |
Foreign currency translation adjustment | 0 | 0 | 0 | 3,317 | 0 | 3,317 | |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (1,694) | 0 | 0 | (46,593) | (48,287) |
Balance at Dec. 31, 2020 | $ 0 | $ 1,240 | 658,246 | (8,034) | 589 | (570,501) | 81,540 |
Balance (in shares) at Dec. 31, 2020 | 0 | 123,943,829 | |||||
Issuance of common stock pursuant to financing agreements | $ 0 | $ 159 | 32,341 | 0 | 0 | 0 | 32,500 |
Issuance of common stock pursuant to financing agreements (in shares) | 0 | 15,853,658 | |||||
Stock issuance costs | $ 0 | $ 0 | (2,019) | 0 | 0 | 0 | (2,019) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 7,770 | 0 | 0 | 0 | 7,770 |
Foreign currency translation adjustment | 0 | 0 | 0 | 1,365 | 0 | 1,365 | |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (1,512) | 0 | 0 | (35,142) | (36,654) |
Balance at Dec. 31, 2021 | $ 0 | $ 1,399 | $ 694,826 | $ (8,034) | $ 1,954 | $ (605,643) | $ 84,502 |
Balance (in shares) at Dec. 31, 2021 | 0 | 139,797,487 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (35,842,000) | $ (47,511,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation for property, plant and equipment | 468,000 | 562,000 |
Loss on disposal of property, plant and equipment | 65,000 | 0 |
Amortization of intangible assets and held-for-sale assets | 1,347,000 | 1,397,000 |
Reduction in the carrying amount of the right-of-use assets | 1,280,000 | 1,272,000 |
Gain on disposal of intangible assets | (1,152,000) | |
Impairment of intangible assets | 1,537,000 | |
Stock-based compensation expense | 7,770,000 | 7,821,000 |
Acquired in-process research and development | 6,555,000 | 17,828,000 |
Government grant as a result of loan forgiveness | (472,000) | |
Change in fair value of investments | (5,660,000) | (4,322,000) |
Impairment loss of long-term investments | 865,000 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (5,158,000) | (3,352,000) |
Inventories | (551,000) | 3,186,000 |
Prepaid expenses and other assets | (1,303,000) | (184,000) |
Accounts payable | 1,491,000 | (1,540,000) |
Accrued liabilities and other liabilities | 2,354,000 | (1,393,000) |
Deferred income | (51,000) | (35,000) |
Net cash used in operating activities | (26,842,000) | (25,886,000) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from disposal of intangible assets | 0 | 2,700,000 |
Proceeds from disposal of property and equipment | 10,000 | |
Purchases of property, plant and equipment | (8,945,000) | (1,499,000) |
Loan to a related party | (10,033,000) | |
Receipt of repayment of loan from a related party | 10,033,000 | |
Cash paid to acquire in-process research and development | (6,555,000) | (17,828,000) |
Receipt of repayment of Black Belt Convertible note | 172,000 | |
Receipt of government grants related to land use right | 474,000 | 2,309,000 |
Net cash used in investing activities | (20,691,000) | (20,719,000) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from notes payable | 466,000 | |
Proceeds from bank borrowings | 709,000 | 783,000 |
Repayment of bank borrowings | (1,548,000) | |
Stock issuance costs | (2,019,000) | (2,818,000) |
Proceeds from sale of common stock | 32,500,000 | 45,099,000 |
Proceeds from exercise of stock options | 3,874,000 | |
Repurchase of stock options to satisfy tax withholding obligations | (251,000) | |
Net cash provided by financing activities | 29,642,000 | 47,153,000 |
Effect of exchange rate change on cash and cash equivalents | (469,000) | 2,895,000 |
Net (decrease)/ increase in cash and cash equivalents | (18,360,000) | 3,443,000 |
Cash and cash equivalents at beginning of period | 57,064,000 | 53,621,000 |
Cash and cash equivalents at end of period | 38,704,000 | 57,064,000 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 42,000 | |
Non-cash investing and financing activities: | ||
Purchases of property, plant and equipment in accrued and other current liabilities | 3,288,000 | 467,000 |
Government grant as a result of loan forgiveness (Note 10) | 472,000 | |
BioInvent International AB | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Payments to acquire equity Investments | (6,318,000) | |
Black Belt Tx Limited | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Cash paid to acquire convertible loan | (86,000) | $ (83,000) |
Alesta Tx | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Cash paid to acquire convertible loan | (261,000) | |
Cleave Therapeutics, Inc | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Cash paid to acquire convertible loan | $ (5,500,000) |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2021 | |
DESCRIPTION OF BUSINESS | |
DESCRIPTION OF BUSINESS | CASI Pharmaceuticals, Inc. Notes to Consolidated Financial Statements December 31, 2021 and 2020 1. DESCRIPTION OF BUSINESS CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) 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 was incorporated in 1991, and in 2012, with new leadership, the Company shifted its business strategy to China and has since built an infrastructure in China that includes sales and marketing, medical affairs, regulatory and clinical development and in the foreseeable future, manufacturing. 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 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 is executing its plan to become a biopharmaceutical leader by launching medicines in the greater China market leveraging its China-based regulatory, clinical and commercial competencies and its global drug development expertise. The Company launched its first commercial product, EVOMELA ® ® ● CNCT19 is an autologous CD19 CAR-T investigative product (“CNCT19”) being developed by our partner Juventas Cell Therapy Ltd. (“Juventas”) for which the Company has exclusive World-Wide co-commercial and profit-sharing rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia (“B-ALL”) and B-cell non-Hodgkin lymphoma (“B-NHL”). The CNCT19 Phase 1 studies in patients with B-ALL and B-NHL in China have been completed by Juventas, the Phase 2 B-ALL and B-NHL registration studies are both currently enrolling in China since the fourth quarter of 2020. ● BI-1206 is an antibody which has a novel mode-of-action, blocking the inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity and enhance the efficacy of antibody-based immunotherapy in both hematological malignancies and solid tumors for which the Company has licensed exclusive greater China rights from BioInvent International AB (“BioInvent”). BI-1206 is being investigated by BioInvent in a Phase 1/2 trial, in combination with anti-PD1 therapy Keytruda ® (pembrolizumab), in patients with solid tumors, and in a Phase 1/2a trial in combination with MabThera ® (rituximab) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). BI-1206 has the potential to restore the activity of rituximab in patients with relapsed/refractory non-Hodgkin lymphoma. Clinical Trial Application (CTA) was approved by China National Medical Products Administration (NMPA) in December 2021. The Company is planning Phase 1 trials of BI-1206 as a single agent to evaluate the PK/safety profile and in combination with rituximab in patients with NHL (mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma) to assess safety and tolerability, select the Recommended Phase 2 Dose and assess early signs of clinical efficacy as part of its development program for BI-1206 in China. The studies are expected to start in the first half of 2022. ● CB-5339 is a novel VCP/p97 inhibitor focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in the treatment of patients with various malignancies. The Company entered into an exclusive license on March 21, 2021 with Cleave Therapeutics, Inc. (“Cleave”) for the development and commercialization of CB-5339 in Mainland China, Hong Kong, Macau and Taiwan. CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, is being evaluated in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CB-5339 CTA application for the multiple myeloma indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation (“CDE”). ● CID-103 is a full human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies for which the Company has exclusive global rights. CID-103 is being developed for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103, in patients with previously treated, relapsed or refractory multiple myeloma is ongoing in France and the UK. The Company also has greater China rights to Octreotide (Long Acting Injectable), a standard of care for the treatment of acromegaly and for the control of symptoms associated with certain neuroendocrine tumors; and Thiotepa, a cytotoxic agent which has a long history of established use in the hematology/oncology setting, the Company has an exclusive China license and distribution rights to a novel formulation of thiotepa, which has multiple indications including use as a conditioning treatment for certain allogeneic haemopoietic stem cell transplants. However, due to the evolving standard of care environment, the rare and niche indication for these products, potential US regulatory action and its commitment to prioritize resources, the Company is currently evaluating its potential opportunities for these products. In addition, the Company’s assets include six FDA-approved ANDAs which it is evaluating due to generic drug pricing reforms by the Chinese government and its impact on the pricing and competitiveness of these products. CASI has built a fully integrated, world class biopharmaceutical company dedicated to the successful development and commercialization of innovative and other therapeutic products. Its business development strategy is currently focused on acquiring additional targeted drugs and immuno-oncology therapeutics through licensing that will expand its hematology/oncology franchise. The Company uses a market-oriented approach to identify pharmaceutical/biotechnology candidates that it believes to have the potential for gaining widespread market acceptance, either globally or in China, and for which development can be accelerated under its global drug development strategy. In many cases its business development strategy includes direct equity investments in the licensor company. The Company intends for its pipeline to reflect a diversified and risk-balanced set of assets that include (1) late-stage clinical drug candidates in-licensed for China or global regional rights, (2) proprietary or licensed innovative drug candidates, and (3) select high quality pharmaceuticals that fit its therapeutic focus. The Company has focused on US/EU approved product candidates, and product candidates with proven targets or product candidates that have reduced clinical risk with a greater emphasis on innovative therapeutics. Although oncology with a focus on hematological malignancies is its principal clinical and commercial target, the Company is opportunistic about other therapeutic areas that can address unmet medical needs. The Company will 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. The Company believes its China operations offer a significant market and growth potential due to the extraordinary increase in demand for high quality medicines coupled with regulatory reforms in China that facilitate the entry of new pharmaceutical products into the country. The Company will continue to in-license clinical-stage and late-stage drug candidates, and leverage its cross-border operations and expertise, and hope to be the partner of choice to provide access to the China market. The Company expects the implementation of its plans will include leveraging its resources and expertise in both the U.S. and China so that the Company can maximize regulatory, development and clinical strategies in both countries. The Company’s commercial product, EVOMELA ® ® ® As part of the long-term strategy to support its future clinical and commercial manufacturing needs and to manage its supply chain for certain products, on December 26, 2018, the Company established CASI Pharmaceuticals (Wuxi) Co., Ltd.. (“CASI Wuxi”) to develop a future GMP manufacturing facility that will be in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. 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. Pursuant to the agreement, CASI Wuxi has committed to invest land use right and property, plant and equipment of RMB 1 billion (equivalent to $143 million) by August 2022. In April 2020, CASI Wuxi received RMB 15.9 million (equivalent to $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. In November 2021, CASI Wuxi received additional RMB 3.0 million (equivalent to $0.5 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 November 2021. In 2020, for the design and construction work of the land, CASI Wuxi entered into several contracts for RMB 76.1 million ($12.0 million) to complete the phase 1 project of CASI Wuxi's research and development production base, the project was the estimated to be completed in October 2023. In February 2022, CASI Wuxi has reached an alignment with the Wuxi local government that it will collaborate with Wuxi LP to co-develop the land continuously in the future, and the development plan will be extended, details regarding the plan are under negotiation. Also in 2020, CASI Wuxi entered in to a lease agreement with local government for a manufactory building next to the leased land. Since then, the Company entered into a series of contracts for the remodeling and installation work of the building and warehouse, as well as purchase of equipments. The total contract amount entered into for this building is approximately RMB 92.9 million ($14.6 million). Certain line item, as disclosed below, in the December 31, 2020 consolidated financial statements has been reclassified to conform to the December 31, 2021 presentation. Payables related to property and equipment in the amount of $0.5 million as of December 31, 2020, which was previously included in accounts payable, and has been reclassified as accrued and other current liabilities on the consolidated balance sheet as of December 31, 2020 (see Note 8). Liquidity and Capital Resources Since its inception in 1991, the Company has incurred significant losses from operations and, as of December 31, 2021, has incurred an accumulated deficit of $605.6 million. Taking into consideration the cash and cash equivalents as of December 31, 2021, the Company believes that it has sufficient resources to fund its operations at least one year beyond the date that the consolidated financial statements are issued. As of December 31, 2021, the Company had a balance of cash and cash equivalents of $38.7 million, of which $19.3 million was held in the financial institutions in the PRC. 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 or opportunities. Risks and Uncertainties During the peak of the COVID-19 pandemic in 2020, the Company experienced disruptions to the EVOMELA® marketing and sales activities as well as to the supply chain for EVOMELA®. The COVID-19 pandemic also impacted the targeted start time of its CID-103 trial due to the lock down of many medical facilities in Europe. During 2021, the Company has experienced minimal disruption to its business activities or supply chain as a result of the COVID-19 pandemic. Furthermore, in June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated, relapsed or refractory multiple myeloma. The study is designed to assess the safety, tolerability, pharmacology and clinical activity of CID-103. The Company currently relies on a single source for the supply of EVOMELA®. The continuation of the COVID-19 pandemic or the emergence of new COVID-19 variants or new pandemics may affect the economies and financial markets of many countries, which may result in a period of economic slowdown or recessions. In such an event, its ability to continue to commercialize and expand distribution of EVOMELA® could be adversely affected if the supplier refuses or is 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 have to work with Acrotech to negotiate an agreement with a substitute supplier, which, assuming a substitute supplier was available, would likely interrupt the manufacturing of EVOMELA®, cause supply chain delays and increase costs. 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 its existing product pipeline. Early in the COVID-19 pandemic, the Company experienced a disruption to its supply chain for EVOMELA®, it has experienced no supply disruption in 2021; however, there can be no assurance that 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 our ability to in-license clinical-stage and late-stage drug candidates in China or elsewhere. License and Distribution Agreements Acrotech License Arrangements The Company has product rights and perpetual exclusive licenses from Acrotech Biopharma L.L.C. (“Acrotech”) to develop and commercialize its commercial product EVOMELA ® ® ® ® China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. In March 2019, the Company entered into a three-year exclusive distribution agreement with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. (“CRPCGIT”) to appoint CRPCGIT on an exclusive basis as its distributor to distribute EVOMELA ® ® ® Juventas Cell Therapy Ltd. 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 (the “Juventas license agreement”). Juventas is a China-based company engaged in cell therapy. The terms of the agreement include RMB 70 million ($10 million) of milestone payments upon the registration of Phase II clinical trial of CNCT19 and sales royalty payments. The milestone was 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 3), which was expensed as acquired in-process research and development in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2020. 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 net profits generated from commercial sales of CNCT19 in addition to the royalty fee payment calculated as a percentage of net sales. The Supplementary Agreement also specifies a minimum annual target net profit to be distributed to Juventas and certain other terms and obligations. In return, the Company obtained additional equity interests in Juventas (see Note 3). Under the Supplementary Agreement, Juventas and the Company will jointly market CNCT19, including, but not limited to, establishing medical teams, developing medical strategies, conducting post-marketing clinical studies, establishing Standardized Cell Therapy Centers, establishing and training providers with respect to cell therapy, testing for cell therapy, and monitoring quality controls (cell collection and transfusion, etc.), and patient management (adverse reactions treatment, patients’ follow-up visits, and establishment of a database). The Company also will reimburse Juventas for a portion of Juventas’ marketing expenses as reviewed and approved by a joint commercial committee to be constituted. The Company will continue to be responsible for recruiting and establishing a sales team to commercialize CNCT19. BioInvent International AB In October 2020, the Company entered into an exclusive licensing agreement with BioInvent International AB (“BioInvent”) 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. BI-1206 is being investigated in a Phase 1/2 trial, in combination with anti-PD1 therapy Keytruda ® (pembrolizumab), in patients with solid tumors, and in a Phase 1/2a trial in combination with MabThera ® (rituximab) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). 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. CASI made a $5.9 million upfront payment in November 2020 to BioInvent and will pay 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. Because BI-1206 underlying the acquired rights has not reached technological feasibility and has no alternative future uses, the Company expensed $5.9 million as acquired in-process research and development in the accompanying consolidated statement of operations and comprehensive loss for the year ended December 31, 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 Company expects that its clinical materials and commercial inventory will be supplied by one or more contract manufacturers with whom the Company has contracted with. Under the terms of the agreement, CASI obtained global rights to CID-103 for an upfront payment of 5 million euros ($5.7 million) and would pay up to $46.3 million in development milestone payments and certain royalties based on sales milestones. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment in June 2021 and €250,000 ($305,000) payment in August 2021 under the terms of the agreement. Because CID-103 underlying the acquired rights has not yet reached technological feasibility and has no alternative uses, the Company expensed 5 million euros as acquired in-process research and development in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2019, and $1.1 million as acquired in-process research and development in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021. Cleave Therapeutics, Inc. In March 2021, the Company entered into an exclusive license with Cleave Therapeutics, Inc. (“Cleave”) for the development and commercialization of CB-5339, an oral novel VCP/p97 inhibitor, in both hematological malignancies and solid tumors, in Mainland China, Hong Kong, Macau and Taiwan. Cleave is a clinical-stage biopharmaceutical company focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in the treatment of patients with cancer. Cleave and the Company will develop CB-5339 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in China and associated markets. The Company paid a $5.5 million upfront payment to Cleave and will pay up to $74 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of CB-5339. CB-5339 is being evaluated by Cleave in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Because CB-5339 has not yet reached technological feasibility and has no alternative future uses, the Company expensed the $5.5 million upfront payment as acquired in-process research and development in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021. 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, 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. CASI intends to advance the development, import drug registration, and market approval of this product in China. 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, of which 1.5 million euros ($1.7 million) was paid by the Company with achievements of certain milestones and was expensed as acquired in-process research and development in the accompanying consolidated statement of operations and comprehensive loss for the year ended December 31, 2020. CASI is responsible for the development, import drug registration, product approval and commercialization in China. CASI has a 10-year Riemser Pharma GmbH In August 2019, the Company entered into a distribution agreement in China with Riemser Pharma GmbH (“Riemser”) to a novel formulation of thiotepa, a chemotherapeutic agent, which has multiple potential indications including use as a conditioning treatment for use prior to allogenic hematopoietic stem cell transplantation. Thiotepa has a long history of established use in the hematology/oncology setting. Pursuant to the distribution agreement, CASI obtained the exclusive distribution right of the products in China, and Riemser will be responsible for manufacturing and supplying CASI with clinical materials and commercial inventory. The Company is applying NADA registration and, subject to regulatory and marketing approvals, the Company intends to advance and commercialize this product in China. In January 2020, Riemser was acquired by Esteve Healthcare, S.L. (“ESTEVE”), an international pharmaceutical company headquartered in Barcelona. There is no contingent milestone payment due to Riemser under the agreement. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Use of Estimates The preparation of 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 inventories, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments. 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. Consolidation The accompanying 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 China, CASI Wuxi, CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”), CASI Pharmaceuticals (Hainan) Co., Ltd. (“CASI Hainan”) and ZhongBio (Beijing) Tech Co. Ltd. ("ZhongBio”). CASI China is a 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 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. Accordingly, the financial statements of CASI Wuxi have been consolidated in the Company's consolidated financial statements since its inception. CASI Hainan and ZhongBio are wholly owned subsidiaries of CASI China and was established in June 2021 and September 2016, respectively. 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. Foreign Currency Translation and Transactions The accompanying consolidated financial statements of the Company are reported in US dollars. The financial position and results of operations of the Company’s subsidiaries in the PRC are measured using the Renminbi (RMB), which is the local and functional currency of these entities. Assets and liabilities of the Company’s PRC subsidiaries are translated into US$ using the exchange rates in effect at the consolidated balance sheet date. The revenues and expenses of these entities are translated into US$ at the weighted average exchange rates for the period. The resulting translation gains (losses) are recorded in accumulated other comprehensive loss as a component of shareholders’ equity. Transactions denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Net gains or losses resulting from foreign currency denominated transactions are recorded in foreign exchange gain (losses) in the consolidated statements of operations and comprehensive loss. Revenue Recognition Product sales recognized in the consolidated statements of operations and comprehensive loss are considered revenue from contracts with customers and, accordingly, 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 the Company satisfies a performance obligation. The Company recognizes revenue on sales of EVOMELA ® 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. There was no product exchange during the years ended December 31, 2021 and 2020. As of December 31, 2021 and 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 December 31, 2021 and 2020. Concentrations Risks Cash Concentration Risk The Company maintains its U.S. and RMB cash in bank deposit accounts, which, at times, may exceed regulated insured limits. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. Vendor Concentration Risk The Company has a sole supplier for its EVOMELA ® ® Accounts Receivable and Credit Concentration CRPCGIT is the sole customer of the Company's EVOMELA ® The Company extends credit to CRPCGIT 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 were necessary as of December 31, 2021 and 2020. The balance of accounts receivable as of December 31, 2021 has been subsequently collected. Fair Value of Financial Instruments Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. 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. See Note 3 and Note 19 for additional fair value disclosures. Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days that are readily convertible to known amounts of cash. Inventories Inventories consist of EVOMELA ® Property, Plant and Equipment Property, plant and equipment are stated at cost, less accumulated depreciation and impairment, if any. Costs incurred in the construction of property, plant and equipment, including down payments and progress payments, are initially capitalized as construction-in-progress and transferred into their respective asset categories when the assets are ready for their intended use, at which time depreciation commences. Furniture and equipment are depreciated over their estimated useful lives of 3 to 5 years. Leasehold improvements are amortized over the shorter of their useful lives or the lease term. Depreciation and amortization expense are determined on a straight-line basis. Costs of Revenues Costs of revenues consist primarily of the cost of inventories of EVOMELA ® ® Investments The Company’s investments consist of investments in equity securities with readily determinable fair value, equity securities without readily determinable fair value, and investments measured using fair value option. Investment in equity securities with readily determinable fair value are measured at fair values, and any changes in fair value are recognized in earnings. Where the fair value of an investment in equity securities is not readily determinable, the Company recognizes such investment in long-term investments, and uses the measurement alternative of 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. For equity investments measured at fair value with changes in fair value recorded in earnings, the Company does not assess whether those securities are impaired. For equity investments without readily determinable fair value, at each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. Impairment indicators that the Company considers include, but are not limited to, (i) the deterioration of earnings performance, credit rating, asset quality, or business prospects of the investee, (ii) a significant adverse change in the regulatory, economic, or technological environment of the investee, (iii) a significant adverse change in the general market condition of either the geographic area or the industry in which the investee operates. If a qualitative assessment indicates that the investment is impaired, the Company has to estimate the investment’s fair value and if the fair value is less than the investment’s carrying value, the Company recognizes an impairment loss in non-operating expenses equal to the difference between the carrying value and fair value. Dividend income is recognized in other income when earned. The Company elected to use fair value option to account for its investment in Cleave (see Note 3) as permitted under Accounting Standards Codification (“ASC”) 825, Financial Instruments (“ASC 825”), which then refers to ASC 820, Fair Value Measurement (“ASC 820”) to provide the fair value framework for valuing such investments. In accordance with ASC 820, the Company records such investment at fair value, with changes in fair value recorded in change in fair value of investments in the consolidated statements of operations and comprehensive loss. Leases At contract inception, the Company determines whether an arrangement is or contains a lease and whether the lease should be classified as an operating or a financing lease. A contract is or contains a lease if the contract conveys the right to control the use of the identified asset for a period of time in exchange for consideration. Control is determined based on the right to obtain all of the economic benefits from use of the identified asset and the right to direct the use of the identified asset. Right of use (“ROU”) assets for operating leases represent the right to use an underlying asset for the lease term, and operating lease liabilities represent the obligation to make lease payments. ROU assets and lease liabilities are recognized upon lease commencement for operating leases based on the present value of lease payments over the lease term. As the rate implicit in the lease cannot be readily determined, the Company uses incremental borrowing rate at the lease commencement date in determining the imputed interest and present value of lease payments. The incremental borrowing rate was determined based on the rate of interest that the Company would have to borrow an amount equal to the lease payments on a collateralized basis over a similar term. The incremental borrowing rate is primarily influenced by the risk-free interest rate of China and the US, the Company’s credit rating and lease term, and is updated for measurement of new lease liabilities. For operating leases, the Company recognizes a single lease cost on a straight-line basis over the remaining lease term. The Company has elected not to recognize ROU assets or lease liabilities for leases with an initial term of 12 months or less; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. In addition, the Company has elected not to separate non-lease components (e.g., common area maintenance fees) from the lease components. Land use rights acquired are recognized in right-of-use assets if they meet the definition of lease. Impairment of Long-Lived Assets Long-lived assets, including property, plant and equipment, operating lease right-of-use (“ROU”) assets and intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Such events and circumstances include the use of the asset or asset group in current research and development projects and any potential alternative future uses of the asset or asset group. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. Impairment charges related to intangible assets were $0 and $1.5 million for the years ended December 31, 2021 and 2020, respectively. Research and Development Expenses Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical testing and clinical trials of the Company’s product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses, along with the amortization of acquired ANDAs. Research and development costs are expensed as incurred. Acquired In-Process Research and Development Expense The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under U.S. GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. The Company also pays contingent development milestone payments in accordance with agreements (see Note 1). The Company recognizes development milestone payments as acquired in-process research and development expenses when the milestones are reached. Stock-Based Compensation The Company records compensation expense associated with service and performance-based stock options in accordance with provisions of authoritative guidance. The estimated fair value of service-based awards is measured on the grant date and is generally recognized on a straight-line basis over the requisite service period and based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. If the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation expense relating to those awards are reversed as occurred. Grant date fair value was determined using an option pricing model which is affected by the fair value of underlying ordinary shares as well as assumptions regarding a number of complex and subjective variables, such as expected volitality, expected term of options, risk-free rate, and expected dividend yield. 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. Income Taxes Income tax expense is recognized using the asset and liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities and operating loss and tax credit carryforwards as measured by the enacted tax rates that will be in effect when these differences reverse. A valuation allowance is provided to reduce the amount of deferred income tax assets if it is considered more likely than not that some portion or all of the deferred income tax assets will not be realized. The Company recognizes in its consolidated financial statements the impact of a tax position if a tax return position or future tax position is “more likely-than-not” to be sustained upon examination, based on the technical merits of the position. Tax positions that meet the “more-likely-than-not” recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. The Company recognizes interest and penalties related to uncertain tax positions, if any, in income tax expense. Net Loss Per Share Net loss per share (basic and diluted) was computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding. 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. ASU 2018-13 eliminates, adds and modifies certain disclosure requirements for fair value measurements. The amendments applicable to the disclosures of changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial year of adoption. This ASU is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted, and an entity is also permitted to early adopt any removed or modified disclosures and delay adoption of the additional disclosures until their effective date. The Company adopted this guidance effective January 1, 2020. The adoption of this new accounting standard did not have a significant impact on the Company's consolidated financial statements. Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments to the initial guidance including ASU No. 2018-19, ASU No. 2019-04, and ASU No. 2019-05 (collectively, “Topic 326”). Topic 326 requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for public business entities, excluding entities eligible to be smaller reporting companies for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, this standard is effective for annual and interim periods beginning after December 15, 2022 and early adoption is permitted for annual and interim periods beginning after December 15, 2018. As a smaller reporting company, the Company expects to adopt this standard in fiscal year 2023. The Company is currently assessing the impact that the adoption of this ASU will have on the consolidated financial statements. There are no other recently issued accounting pronouncements that are expected to have a material effect on the Company’s financial position, results of operations or cash flows. |
INVESTMENT IN EQUITY SECURITIES
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS | 12 Months Ended |
Dec. 31, 2021 | |
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS | |
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS | 3. INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS Investment in equity securities, at fair value MaxCyte Inc. The Company has an equity investment in the common stock of MaxCyte, a publicly traded company. The Company’s investment in this equity security is carried at its fair value, with changes in fair value reported in the consolidated statements of operations and comprehensive loss in each reporting period. The fair value of this security was measured using its quoted market price, a Level 1 input, and was $3.9 million as of December 31, 2021 and $2.7 million on December 31, 2020 (see Note 19). BioInvent International AB In October 2020, in conjunction with its license agreement entered into with BioInvent (see Note 1), a publicly traded company, CASI made a $6.3 million investment (equivalent to SEK 53.8 million) to acquire 1.2 million new shares (after 25:1 reverse stock split) of BioInvent, and 14,700,000 warrants, each warrant with a right to subscribe for 0.04 shares (after 25:1 reverse stock split) in BioInvent within a period of five years. The investments in the ordinary shares and warrants of BioInvent are carried at fair value, with changes in fair value reported in the statement of operations each reporting period. The fair value of the ordinary shares was measured using its quoted market price, a Level 1 input, and was $6.0 million and $6.6 million as of December 31, 2021 and 2020 (see Note 19). The fair value of the warrants was measured using observable market-based inputs other than quoted prices in active markets for identical assets, level 2 inputs. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of warrants. The fair value of the warrants was $591,000 as of December 31, 2021 (see Note 19), with assumptions including an expected life of 3.91 years, an assumed volatility of 46.32%, and a risk-free interest rate of 0.07%. The fair value of the warrants was $840,000 as of December 31, 2020, with assumptions including an expected life of 4.91 years, an assumed volatility of 47.63%, and a risk-free interest rate of 0.36%. The Company recognized for such warrants unrealized loss of $0.25 million for the year ended December 31, 2021 and unrealized gain of $0.18 million for the year ended December 31, 2020, respectively. The following table summarizes the Company’s investments in equity securities at fair value as of December 31, 2021 and 2020, respectively: Gross (In thousands) unrealized Aggregate fair As of December 31, 2021 Classification Cost gains value MaxCyte - equity interest Investment $ — $ 3,866 $ 3,866 BioInvent - equity interest Investment $ 5,661 $ 341 $ 6,002 Total $ 9,868 Gross (In thousands) unrealized Aggregate fair As of December 31, 2020 Classification Cost gains value MaxCyte - equity interest Investment $ — $ 2,729 $ 2,729 BioInvent - equity interest Investment $ 5,661 $ 919 $ 6,580 Total $ 9,309 Unrealized gains on the Company’s equity investments for the years ended December 31, 2021 and 2020 were $1.1 million and $3.0 million, respectively. Unrealized lossess on the Company’s equity investments for the years ended December 31, 2021 and 2020 were $0.6 million and nil, respectively.Unrealized gains (losses) on the Company’s equity investments are recognized as change in fair value of investment in the consolidated statements of operations and comprehensive loss. Long-term investments Long-term investments as of December 31, 2021 and 2020 consisted of the following: Gross Foreign Gross unrealized currency As of December 31, 2021 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Alesta Therapeutics B.V. - convertible loan $ 261 $ 7 $ — $ — $ 268 Securities measured at fair value: BioInvent International AB - warrants 656 — (65) — 591 Cleave Therapeutics, Inc. - convertible loan 5,500 76 — — 5,576 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — (865) — 1,385 Juventas Cell Therapy Ltd - equity interests 23,500 6,958 — 1,850 32,308 Juventas Cell Therapy Ltd - put option 491 — (521) 30 — Total $ 32,658 $ 7,041 $ (1,451) $ 1,880 $ 40,128 Gross Foreign Gross unrealized currency As of December 31, 2020 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Black Belt Tx Limited - convertible loan $ 83 $ — $ — $ — $ 83 Securities measured at fair value: BioInvent International AB - warrants 656 184 — — 840 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — — — 2,250 Juventas Cell Therapy Ltd - equity interests 23,500 1,469 — 1,090 26,059 Juventas Cell Therapy Ltd - put option 491 — (306) 25 210 Total $ 26,980 $ 1,653 $ (306) $ 1,115 $ 29,442 Alesta Therapeutics B.V. (previously Black Belt Tx Limited) In April 2019, in conjunction with its license agreement the Company entered into with Black Belt (see Note 1), 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 Limited (“Black Belt Tx”), representing a 14.1% equity interest with the right to appoint a non-voting board observer. Because the Company does not have significant influence over operating and financial policies of Black Belt Tx, and the equity interests do not yet 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. In July 2021, Alesta Therapeutics B.V. (“Alesta Tx”) was incorporated as the parent company holding all shares of Black Belt Tx with same ownership structure as Black Belt Tx. CASI obtained 14.1% equity interest in Alesta Tx in exchange for its 14.1% equity interest in Black Belt Tx. In July 2021, a new investor contributed 750,000 euros to Alesta Tx in exchange for 770,270 newly issued common stocks, representing 8.3% of the fully diluted capital. Upon the completion of the capital contribution, the Company’s equity ownership in Alesta Tx was diluted from 14.1% to 12.9% with a fair value of $1,385,000, indicating an impairment of equity investment in Black Belt Tx. The Company recorded impairment of $865,000 representing the difference between the fair value of the investment and its carrying amount during the year ended December 31, 2021. 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 ($250,000) with a non-compounding annual interest rate of 6% payable, together with the principal balance at maturity. The loan principal will be disbursed in three equal installments of 70,600 euros. The first tranche of 70,600 euros ($83,000) was disbursed upon execution of the loan agreement in August 2020. The second tranche of 70,600 euros ($86,000) was disbursed in February 2021, upon Black Belt Tx’s achievement of certain operational targets as stipulated in the loan agreement and approved by the Black Belt Tx’s Board of Directors. The third tranche would have been disbursed if Black Belt Tx reaches certain additional operational targets as stipulated in the loan agreement and approved by Black Belt Tx's Board of Directors. 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 ($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. In July 2021, Black Belt Tx repaid the convertible loan of 146,566 ($172,000) euros to the Company, including 1st tranche of 70,600 euros ($83,000), 2nd tranche of 70,600 euros ($83,000)and interest of 5,366 euros ($6,000). Concurrently, the Company entered into a three-year convertible loan agreement with Alesta Tx (the “Alesta Tx Loan”) in the amount of 217,166 euros ($261,000) with a non-compounding annual interest rate of 6% payable, together with the principal balance, at maturity. Juventas Cell Therapy Ltd. In June 2019, in conjunction with its license agreement entered into with Juventas (see Note 1), 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 interests on a fully diluted basis, and the right to appoint a non-voting board observer. The Company is entitled to substantive liquidation preference over the founding shareholders of Juventas. In addition, the Juventas’ founding shareholders provided a put option to the Company pursuant to which the Company can put the equity investment to the founding shareholders 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 shareholders 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 1), the Company obtained additional Series A plus equity interests in Juventas with substantive liquidation preference over Juventas’ founding shareholders, resulting in the Company's equity ownership increasing to 16.45% (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 shareholders also provided a put option to the Company pursuant to which the Company can put the additional equity investment to the founding shareholders 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 interests 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 interests 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 1) 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 year ended December 31, 2020. On October 26, 2021, Juventas completed its Series C financing through which it raised capital of RMB 410 million ($63 million). Upon the completion of Juventas Series C financing, the Company’s equity ownership in Juventas decreased to 12.01% on a fully diluted basis. The Company determined the Series C financing represented an orderly transaction for a similar investment of the same issuer. The fair value of the Company’s equity interests in Juventas and the put option was RMB 205.6 million ($32.3 million) and nil on October 26, 2021, respectively. The Company recognized gain of fair value change for equity interests of RMB 35.2 million ($5.5 million) and loss of fair value change for put option of RMB1.4 million ($0.2 million), respectively, in its consolidated statements of operations and comprehensive loss for the year ended December 31, 2021, based on the price in the orderly transaction for newly issued equity interests of Juventas, which is further adjusted to reflect the differences between the newly issued equity interests of Juventas and the Company’s investment. In June 2020, the Company entered into a one-year loan agreement with Juventas in the amount of RMB 30,000,000 ($4,243,000) with an annual interest rate of 20%. In August 2020, the Company entered into another one-year loan with Juventas in the amount of RMB 40 million ($5,790,000) for one year with an annual interest rate of 20%. In September 2020, the Company received early repayments for both principals and accrued interest from Juventas. For the year ended December 31, 2020, the Company recognized interest income of $351,000 and $375,000, respectively, for these two loans. Cleave Therapeutics, Inc. In March 2021, in conjunction with its license agreement entered into with Cleave (see Note 1), CASI made a $5.5 million investment in Cleave through a three-year convertible note with an annual interest rate of 3% payable at maturity. The principal balance is also due at maturity. The proceeds will support and advance Cleave’s programs and general operations. In the event that Cleave, on or prior to the maturity date, completes an equity financing round of preferred stock of at least $10.0 million, then the outstanding principal amount and accrued interest shall be automatically converted into such shares at 80% of the price per share issued. The investment in the convertible loan is designated an investment measured at fair value through profit or loss. The Company recognized fair value change of $76,000 for the year ended December 31, 2021. |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORIES | |
INVENTORIES | 4. INVENTORIES The Company’s inventories consist of finished goods amounted to $1.9 million and $1.4 million, as of December 31, 2021 and 2020, respectively. No provisions to write down the carrying amount of inventory have been recorded in the year ended December 31, 2021 and December 31, 2020. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2021 | |
LEASES | |
LEASES | 5. 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 are included in accrued and other current liabilities and other liabilities (noncurrent) in the consolidated balance sheets as of December 31, 2021 and 2020. As of December 31, 2021 and 2020, the Company did not have any finance leases. 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 RMB45 million (equivalent to $6.5 million). Rent expense for the years ended December 31, 2021 and 2020 was $1,452,000 and $1,600,000, respectively. There were no variable lease costs or sublease income for leased assets for the years ended December 31, 2021 and 2020. Right of use assets and liabilities as of December 31, 2021 and 2020 were classified on the consolidated balance sheets as follows: December 31, December 31, (In thousands) 2021 2020 Right of use assets $ 9,107 $ 8,696 Accrued and other current liabilities $ 1,061 $ 939 Other liabilities 1,105 965 Total lease liabilities $ 2,166 $ 1,904 Supplemental cash flow information related to leases was as follows: Year Ended December 31, (In thousands) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,354 $ 1,375 Right of use assets obtained in exchange for lease obligations: $ 1,525 $ 1,196 All of the Company’s existing leases as of December 31, 2021 and 2020 are classified as operating leases. As of December 31, 2021 and 2020, the Company had eight and seven, respectively, material operating leases for land and facilities with remaining terms expiring from 2022 through 2069 and a weighted average remaining lease term of 36.47 years and 38.37 years, respectively. The Company has fair value renewal options for many 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 for 2021 and 2020 is 3.56% and 3.72%, respectively. 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. A maturity analysis representing the future undiscounted cash flow of the Company’s operating leases liabilitiesas of December 31, 2021 is as follows: (In thousands) 2022 $ 1,122 2023 774 2024 359 Total 2,255 Discount factor (89) Lease liability 2,166 Amounts due within 12 months 1,061 Non-current lease liability $ 1,105 |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY, PLANT AND EQUIPMENT | |
PROPERTY, PLANT AND EQUIPMENT | 6. PROPERTY, PLANT AND EQUIPMENT The Company’s property, plant and equipment (“PP&E”) mainly includes construction in progress (“CIP”), furniture and equipment, and leasehold improvements. Construction in progress (“CIP”) is stated at cost and includes costs incurred to acquire, construct, or install PP&E. CIP overhead is expensed as incurred. Construction in progress is not depreciated until such time when the asset is substantially completed and ready for its intended use. Furniture and equipment are stated at cost and are depreciated over their estimated useful lives of 3 to 5 years. Leasehold improvements are stated at cost and are amortized over the shorter of their useful lives or the lease term. Depreciation and amortization expense are determined on a straight-line basis. 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. In 2020 and 2021, CASI Wuxi entered into a series of construction contracts for the building, remodeling and installation of Wuxi Project. As of December 31, 2021, the project was still under construction and the ending balance of CIP is $12.1 million. Property, plant and equipment consist of the following: (In thousands) December 31, 2021 2020 Furniture and equipment $ 1,728 $ 1,622 Leasehold improvements 1,133 985 Construction in progress 12,095 1,193 Total property, plant and equipment, gross 14,956 3,800 Accumulated depreciation and amortization (1,817) (1,322) Impairment of property, plant and equipment (427) (416) $ 12,712 $ 2,062 Depreciation expense were $468,000 and $562,000 in 2021 and 2020, respectively. The Company recognized no impairment during the years ended December 31, 2021 and 2020. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | 7. INTANGIBLE ASSETS Intangible assets include ANDAs that were acquired as part of 2018 asset acquisitions of U.S. marketed generic products, as well as capitalized costs related to a cloud computing arrangement (“CCA”). These intangible assets were originally recorded at relative estimated fair values based on the purchase price for the asset acquisitions and are stated net of accumulated amortization and impairment, if any. The ANDAs are amortized over their estimated useful lives of 13 years, using the straight-line method. The CCA is being amortized over its useful life of 5 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 consolidated statement of operations and comprehensive loss for the year ended December 31, 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 year ended December 31, 2021. 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. As of December 31, 2021, no FDA approvals have been obtained by Chartwell on those products. Intangible assets at December 31, 2021 and 2020 consists of the following: (In thousands) Asset as of December 31, 2021 Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,832 $ (3,688) 13 years Others 197 (138) 5 years Total $ 16,029 $ (3,826) (In thousands) Asset as of December 31, 2020 Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,832 $ (2,721) 13 years Others 197 (98) 5 years Total $ 16,029 $ (2,819) The changes in intangible assets for the years ended December 31, 2021 and 2020 are as follows: (In thousands) 2021 2020 Balance at the beginning of the year $ 13,210 $ 13,674 Amortization expense (1,347) (1,289) Foreign currency translation adjustment 340 825 Balance at the ending of the year $ 12,203 $ 13,210 Expected future amortization expense is as follows as of December 31, 2021: (In thousands) 2022 $ 1,351 2023 1,351 2024 1,323 2025 1,323 2026 1,323 2027 and thereafter 5,532 |
ACCRUED AND OTHER CURRENT LIABI
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES | |
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES | 8. ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES Year Ended December 31, (In thousands) 2021 2020 Accrued and other current liabilities: Payroll and welfare payable $ 3,336 $ 1,535 Payables related to property and equipment 3,288 467 Lease liabilities-current (Note 5) 1,061 939 Value-added tax and other tax payable 652 434 Other 60 49 $ 8,397 $ 3,424 Other Liabilites Profit-sharing liability to Juventas (Note 3) $ 13,220 $ 12,869 Lease liabilities-noncurrent (Note 5) 1,105 965 $ 14,325 $ 13,834 |
BANK BORROWINGS
BANK BORROWINGS | 12 Months Ended |
Dec. 31, 2021 | |
BANK BORROWINGS | |
BANK BORROWINGS | 9. BANK BORROWINGS On November 3, 2020, Beijing Branch of China CITIC Bank Corporation Limited approved a guaranteed line of credit (“Bank Borrowings”) to the Company with maximum borrowings of RMB 10.0 million ($1.5 million). The joint and several liability guarantee was provided by Beijing Capital Financing Guarantee Co, Ltd.. At December 31, 2020, the Company had outstanding borrowings under the Bank Borrowings of RMB 5.4 million ($0.8 million), which matured and was repaid in on November 7, 2021, and beared interest at a fixed rate of 3.35% per annum. On February 3, 2021, the Company obtained an additional borrowings of RMB 4.6 million ($0.7 million) under the Bank Borrowing which also matured and was repaid in 2021, and beared a fixed interest rate of 3.72% per annum. Interest expense of $41,000 and $1,000 was recorded for the years ended December 31, 2021 and 2020, respectively. |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2021 | |
NOTES PAYABLE | |
NOTES PAYABLE | 10. NOTES 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 Interest expense of $2,900 and $3,100 was recorded for the years ended December 31, 2021 and 2020, respectively. |
GRANTS
GRANTS | 12 Months Ended |
Dec. 31, 2021 | |
GRANTS | |
GRANTS | 11. 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 5). 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 $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 $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. In November 2021, CASI Wuxi received additional RMB 3.0 million (equivalent to $0.5 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 November 2021. As of December 31, 2021 and 2020, deferred income balance represents the grants related to the lease of the land and will be amortized over the remaining term of the lease of the land. The Company recognized $51,000 and $35,000 of other income during the years ended December 31, 2021 and 2020, respectively. |
REDEEMABLE NONCONTROLLING INTER
REDEEMABLE NONCONTROLLING INTEREST | 12 Months Ended |
Dec. 31, 2021 | |
REDEEMABLE NONCONTROLLING INTEREST | |
REDEEMABLE NONCONTROLLING INTEREST | 12. 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. The payment schedule has been changed into three installments of $10 million paid in July 2021, $10 million and $9 million to be paid in 2022 and 2023, respectively. 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. Pursuant to the investment contract between the Company and Wuxi LP and Articles of Association of CASI Wuxi, the Company has the call option to purchase the 20% equity interest in CASI Wuxi held by Wuxi LP at any time within 5 years from the date of establishment of CASI Wuxi (i.e. up to December 26, 2023). Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at any time after December 26, 2023. The redemption value under both the Company’s embedded put option and Wuxi LP’s embedded call option is equal to $20 million plus interest at the bank loan interest rate issued by the People's Bank of China for the period beginning with the initial capital contribution by Wuxi LP to the date of redemption. In addition, Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at $20 million upon the occurrence of any of the following conditions: (i) the Company fails to fulfill its investment obligation to CASI Wuxi; (ii) CASI Wuxi suffers serious losses, discontinued operation, dissolution, goes into process of bankruptcy liquidation; or (iii) the Company substantially violates the investment contract and Articles of Association of CASI Wuxi. 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. The Company initially recorded the redeemable noncontrolling interest at its fair value of $20 million. The carrying amount of the redeemable noncontrolling interest is subsequently recorded at the greater of the amount of (1) the initial carrying amount, increased or decreased for the redeemable noncontrolling interest’s share of net income or loss in CASI Wuxi or (2) the redemption value, assuming the noncontrolling interest is redeemable at the balance sheet date. 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 years ended December 31, 2021 and 2020 are as follows: Year Ended December 31, (In thousands) 2021 2020 Balance at beginning of period $ 22,033 $ 20,670 Share of CASI Wuxi net loss (700) (918) Accretion of redeemable noncontrolling interest 1,512 1,694 Foreign currency translation adjustment 612 587 Balance at end of period $ 23,457 $ 22,033 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2021 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 13. STOCKHOLDERS’ EQUITY The Company had 250 million of authorized common stock at December 31, 2021 and 2020, respectively. The Company had 5 million of authorized preferred stock as of December 31, 2021 and 2020. The Company held 79,545 of shares of common stock in treasury at its acquisition cost at December 31, 2021 and 2020. Stock Repurchase Program On December 15, 2021, the board of directors of CASI Pharmaceuticals, Inc. (the “Company”) approved a stock repurchase program for the repurchase of up to USD 10 million of the Company’s common stock (and no more than 12,500,000 shares of the Company’s common stock) through open market purchases in compliance with Rule 10b-18 under the Securities Exchange Act of 1934 and through trading plans established pursuant to Rule 10b5-1 of the Securities Exchange Act. Under any Rule 10b5-1 trading plan the Company might adopt, the Company’s third-party broker, subject to Securities and Exchange Commission regulations regarding certain price, market, volume and timing constraints, would have authority to purchase the Company’s common stock in accordance with the terms of the plan. The actual timing, number and value of shares repurchased under the stock repurchase program will depend on a number of factors, including constraints specified in any Rule 10b5-1 trading plans, price, general business and market conditions, and alternative investment opportunities. The stock repurchase program does not obligate the Company to acquire any specific number of shares in any period, and may be expanded, extended, modified or discontinued at any time. The Company anticipates funding for stock repurchase program to come from available corporate funds, including cash on hand and future cash flow. As of March 18, 2022, the Company has repurchased 3,207,661 shares of common stock amounted to $2.5 million under a Rule 10b5-1 trading plan that will terminate on March 31, 2022. March 2021 Underwritten Public Offering On March 24, 2021, the Company closed an underwritten public offering of 15,853,658 shares of the Company’s common stock (the “Offering”) at a price to the public of $2.05 per share. The gross proceeds to CASI from the Offering were $32.5 million before deducting the underwriting discounts and commissions and offering expenses payable by CASI. 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. 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 $43.7 million before deducting the underwriting discounts and commissions and offering expenses payable by CASI. Certain insiders, including CASI's Chairman and CEO, 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. CASI's Chairman and CEO purchased 2,952,426 shares directly and ETP Global Fund LP purchased 1,200,000 shares. CASI's President purchased 20,152 shares. Common Stock Sales Agreements On February 23, 2018, the Company entered a Common Stock Sales Agreement (the “Sales Agreement”), as amended, with H.C. Wainwright & Co., LLC (“HCW”) that would allow the Company to sell up to $20 million of shares of common stock in “at-the- market” transactions, subject to compliance with the terms and conditions of the Sales Agreement. In 2018, the Company issued 143,248 shares under the Sales Agreement resulting in net proceeds to the Company of $475,000. During the year ended December 31, 2021, the Company has not offered and sold any shares of common stock under the Sales Agreement. Concurrently with and upon the execution of the new Stock Sales Agreement mentioned below, the Sales Agreement dated as of February 23, 2018, between CASI and HCW, was terminated by mutual agreement of the parties. On July 19, 2019, the Company entered into an Open Market Sale Agreement SM On October 29, 2021, the Company has entered into a common stock sales agreement (“Stock Sales Agreement”), with H.C. Wainwright & Co., LLC, relating to shares of common stock of the Company. In accordance with the terms of the sales agreement, the Company may offer and sell shares of common stock in “at-the-market” transactions, subject to compliance with the terms and conditions of the Stock Sales Agreement, with an aggregate offering price of not more than $20,000,000. As of December 31, 2021, the Company has not offered or sold any shares of common stock under the sales agreement. Stock Purchase Warrants In history, the Company issued shares of its common stock with accompanying warrants to certain institutional investors, accredited investors and existing stockholders. Stock purchase warrants activity for the years ended December 31, 2021 and 2020 is as follows: Number of Weighted Average Warrants Exercise Price Outstanding at December 31, 2019 9,843,720 $ 4.43 Exercised (82,304) $ 1.69 Expired (1,489,707) $ 3.75 Outstanding at December 31, 2020 8,271,709 $ 4.58 Expired (2,098,877) $ 7.19 Outstanding at December 31, 2021 6,172,832 $ 3.69 Exercisable at December 31, 2021 6,172,832 $ 3.69 All outstanding warrants are equity classified and will expire by March 2023. |
COSTS OF REVENUES
COSTS OF REVENUES | 12 Months Ended |
Dec. 31, 2021 | |
COSTS OF REVENUES | |
COSTS OF REVENUES | 14. COSTS OF REVENUES Costs of revenues consists primarily of the cost of inventories of EVOMELA ® ® ® |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2021 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 15. NET LOSS PER SHARE Net loss per share (basic and diluted) was computed by dividing net loss attributable to common stockholders, considering the accretions to redemption value of the redeemable noncontrolling interest, by the weighted average number of shares of common stock outstanding. As of December 31, 2021, and 2020, outstanding stock options totaling 33,243,790 and 16,746,238, respectively, and outstanding warrants totaling 6,172,832 and 8,271,709, respectively, were anti-dilutive, and therefore, were not included in the computation of weighted average shares used in computing diluted 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: Year Ended December 31, (In thousands, except share and per share data) 2021 2020 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (36,654) $ (48,287) Denominator: Weighted average number of common stock 136,105,539 110,452,288 Denominator for basic and diluted net loss per share calculation 136,105,539 110,452,288 Net loss per share — Basic and diluted $ (0.27) $ (0.44) |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2021 | |
EMPLOYEE BENEFIT PLAN | |
EMPLOYEE BENEFIT PLAN | 16. EMPLOYEE BENEFIT PLAN The Company sponsors the CASI Pharmaceuticals, Inc. 401(k) Plan and Trust. The plan covers substantially all U.S. employees and enables participants to contribute a portion of salary and wages on a tax-deferred basis. Contributions to the plan by the Company are discretionary. Contributions by the Company totaled $187,000 and $250,000 for the years ended December 31, 2021 and 2020, respectively. Full time employees of the Company in the PRC participate in a government mandated defined contribution plan, pursuant to which certain pension benefits, medical care, employee housing fund and other welfare benefits are provided to employees. Chinese labor regulations require that the PRC subsidiaries of the Company make contributions to the government for these benefits based on certain percentages of the employees’ salaries. The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $3,137,000 and $1,542,000 for the years ended December 31, 2021 and 2020, respectively. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 17. STOCK-BASED COMPENSATION The Company has adopted various stock compensation plans for executive, scientific and administrative personnel of the Company, as well as outside directors and consultants. In June 2019, the Company’s stockholders approved an amendment to the 2011 Long-Term Incentive Plan (the “2011 Plan” ), increasing the number of shares of common stock reserved for issuance from 20,230,000 to 25,230,000 to be available for grants and awards. On June 15, 2021, the 2021 Long-Term Incentive Plan (the “2021 Plan”) was approved by the Company's stockholders. The maximum number of shares of common stock that are available for grants and awards equals to 20,000,000 shares of stock, which includes 10,726,673 shares of common stock remaining under the 2011 Plan as of April 12, 2021. Currently, the 2021 Plan is administered by the Company’s compensation committee. As of December 31, 2021, a total of 10,515,448 shares remained available for grant under the Company’s 2021 Long-Term Incentive Plan. In addition to the 2011 Plan and the 2021 Plan, the Company also granted stock options to Dr. He, the Company’s Chairman and CEO. On June 20, 2019, the Company’s stockholders approved a grant of stock options to Dr. He at the 2019 Annual Meeting. Under the terms of the grant, Dr. He received a stock option covering 4 million shares of common stock, at an exercise price of $2.85, vesting upon the earlier of (i) the completion of a transformative event by the Company as determined at the discretion of the Company’s compensation committee and (ii) April 2, 2021, the second anniversary of the date of his appointment as CEO. On June 15, 2021, the Board approved a grant of stock options to Dr. He which consists of 4 million shares time-based and 4 million shares performance-based stock options. The share-based compensation expenses are recorded as components of general and administrative expense, selling and marketing expense, and research and development expense, as follows: Year Ended December 31, (In thousands) 2021 2020 Research and development $ 361 $ 245 Sales and Marketing 449 39 General and administrative 6,960 7,537 Share-based compensation expense $ 7,770 $ 7,821 Compensation expense related to stock options with service conditions is recognized over the requisite service period, which is generally the option vesting term of up to five years. Compensation expense related to stock options with performance conditions are recognized when it is probable that the performance condition will be achieved. For the years ended December 31, 2021 and 2020, $2,319,000 and $49,000 was expensed for stock option awards with performance conditions that were probable during the year, 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. Expected Volatility Risk-Free Interest Rate Expected Term of Options Expected Dividend Yield zero Following are the weighted-average assumptions used in valuing the stock options granted to employees during the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Expected volatility 79.68 % 78.70 % Range of expected volatility 75.69%-81.50 % 75.84% to 81.63 % Range of risk free interest rate 0.72%-1.38 % 0.31% to 1.77 % Expected term of option 6.17 years 6.10 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the years ended December 31, 2021 and 2020 were $1.0 and $1.85, respectively. A summary of the Company’s stock option plans and changes in options outstanding under the plans during the years ended December 31, 2021 and 2020 is as follows: Weighted Average Weighted Average Remaining Number of Options Exercise Price Contractual Term In Years Aggregate Intrinsic Value Outstanding at December 31, 2019 18,268,372 $ 2.58 Exercised (2,789,473) $ 1.39 $ 1,856,978 Granted 2,380,686 $ 2.71 Expired (117,722) $ 5.06 Forfeited (995,625) $ 3.78 Cancelled — $ — Outstanding at December 31, 2020 16,746,238 $ 2.71 Exercised — $ — $ — Granted 17,939,552 $ 1.49 Expired (387,000) $ 4.56 Forfeited (1,055,000) $ 2.64 Cancelled — $ — Outstanding at December 31, 2021 33,243,790 $ 2.04 7.71 $ — Vested and expected to vest at December 31, 2021 33,243,790 $ 2.04 7.71 $ — Exercisable at December 31, 2021 15,294,016 $ 2.44 5.81 $ — The aggregate intrinsic value is calculated as the difference between (i) the closing price of the common stock at December 31, 2021 and (ii) the exercise price of the underlying awards, multiplied by the number of options that had an exercise price less than the closing price on the last trading day of the year. Cash received from option exercises under all share-based payment arrangements for the twelve months ended December 31, 2021 and 2020 was $0 and $3.9 million, respectively. The following summarizes information about stock options that are outstanding at December 31, 2021: Options Outstanding Options Exercisable Weighted Average Weighted Weighted Number Remaining Average Number Average Range of Outstanding at Contractual Exercise Exercisable at Exercise Exercise Prices December 31, 2021 Life in Years Price December 31, 2021 Price $0.00 - $1.00 3,223,853 7.66 $ 0.87 1,373,853 $ 0.87 $1.01 - $2.00 20,495,481 7.98 $ 1.52 6,158,707 $ 1.47 $2.01 - $4.00 8,209,456 7.25 $ 2.99 6,746,456 $ 2.94 $4.01 - $7.00 1,110,000 6.65 $ 6.82 810,000 $ 6.89 $7.01 - $9.00 205,000 6.50 $ 8.23 205,000 $ 8.23 33,243,790 7.71 $ 2.04 15,294,016 $ 2.44 As of December 31, 2021, there was $16,148,000 of total unrecognized compensation cost related to non-vested stock options, excluding not-probable performance condition options. That cost is expected to be recognized over a weighted-average period of 2.7 years. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES | |
INCOME TAXES | 18. INCOME TAXES For financial reporting purposes, loss before income taxes includes the following components: (In thousands) 2021 2020 United States $ (32,169) $ (40,626) PRC (3,673) (6,885) Total $ (35,842) $ (47,511) Significant components of the Company’s deferred income tax assets and liabilities as of December 31, 2021 and 2020 are as follows: December 31, (In thousands) 2021 2020 Deferred income tax assets: Net operating loss carryforwards $ 69,684 $ 78,790 Research and development credit carryforwards 4,259 6,244 Intangible assets 8,051 8,049 Stock-based compensation 5,336 5,126 Impairment loss of long-term investments 182 — Others 540 394 Valuation allowance for deferred income tax assets (83,651) (94,986) $ 4,401 $ 3,617 Deferred income tax liabilities: Deferred Royalty Income (2,342) (2,823) Change in fair value of investments (1,865) (690) Others (194) (104) $ (4,401) $ (3,617) The Company has U.S. federal and state net operating loss (NOL) carryforwards of $302.1 million at December 31, 2021. Federal and certain state NOLs generated after 2017, have indefinite lives. Certain NOLs generated prior to 2018 begin to expire in years 2022 through 2037. The Company also has People’s Republic of China (“PRC”) NOLs carryforward of $24.2 million at December 31, 2021 that begin to expire in years 2022 through 2026. The Company also has research and experimentation (“R&E”) tax credit carryforwards of $4.3 million as of December 31, 2021 that begin to expire in years 2022 through 2038. Unused R&E tax credit carryforwards expire after a period of 20 years. Under the provisions of the Internal Revenue Code, the NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. For financial reporting purposes, a 100% valuation allowance has been recognized to reduce the net deferred tax assets to zero because it is more likely than not that the Company could not generate sufficient taxable income in the future to realize the benefit of deferred income tax assets. A reconciliation of the provision for income taxes to the federal statutory rate is as follows: (In thousands) 2021 2020 Tax benefit at statutory rate of 21% $ (7,526) $ (9,977) State taxes — (732) Attribute expiration 10,676 13,707 Change in applicable tax rates 7,117 11,612 Nondeductible expenses 1,059 358 Deemed royalty — 4,220 Others 9 (54) Change in valuation allowance (11,335) (19,134) $ — $ — Note (1) Change in applicable tax rates represents the difference between the US federal statutory tax rate and the PRC statutory tax rate applied to the entities that operate in PRC. Additionally, change in applicable tax rates reflects the reduction of the Company’s deferred tax assets related to the change in the Company’s activities in and the tax laws of certain states. A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: (In thousands) 2021 2020 Unrecognized tax benefits balance at January 1 $ 2,082 $ 2,581 Reductions for tax positions of prior periods (642) (499) Additions for tax positions of current period — — Unrecognized tax benefits balance at December 31 $ 1,440 $ 2,082 The Company had $1.4 million of unrecognized tax benefits as of December 31, 2021 related to net R&E tax credit. For the year ended December 31, 2021, there was a net reduction of unrecognized tax benefits of $0.6 million related to R&E tax credits. The Company has a full valuation allowance at December 31, 2021 and 2020 against the full amount of its net deferred tax assets and, therefore, there was no impact on the Company’s financial position. The Company does not expect significant changes to the unrecognized benefit during 2020. As of December 31, 2021 and 2020, the Company did not accrue any interest related to uncertain tax positions. To date, there have been no interest or penalties charged to the Company related to income taxes. The Company and each of its PRC subsidiaries file income tax returns in the United States and the PRC, respectively. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), all of the Company’s tax returns since 1999 are open to examination by the taxing authorities. According to the PRC Tax Administration and Collection Law, the statute of limitations is three years if the underpayment of taxes is due to computational errors made by the taxpayer or the withholding agent. The statute of limitations is extended to five years under special circumstances where the underpayment of taxes is more than RMB100,000 ($14,334). In the case of transfer pricing issues, the statute of limitations is ten years. There is no statute of limitations in the case of tax evasion. In the US, the Company is no longer subject ot income tax examinations by authorities for years ended on or before December 31, 2017 except for certain states where the open periods are one year longer. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2021 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | 19. FAIR VALUE MEASUREMENTS Financial instruments of the Company primarily consist of cash and cash equivalents, investment in equity securities, accounts receivable, long-term investments, accounts payable, accrued liabilities, notes payable and bank borrowings. As of December 31, 2021 and 2020, the carrying amount of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, notes payable and bank borrowings are carried at cost which approximates their fair values due to the short-term nature of the instruments. 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 equity investments in the common stock of two publicly traded companies. The Company’s investments in these equity securities are carried at their estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period (see Note 3). The fair value of the common stock is based on quoted market price for the investees’ common stock, a Level 1 input. The Company has an equity investment in the warrants of a publicly traded company. The Company’s investment 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 3). The fair value of the warrants was measured using observable market-based inputs other than quoted prices in active markets for identical assets, level 2 inputs. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of warrants. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the fair value determination of a warrant. The Company has an investment in the convertible debt of Black Belt Tx. The Company’s investment 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 3) using Level 3 input. The Company has an investment in the convertible debt of Cleave. The Company’s investment 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 3) using Level 3 input. The following tables present the Company’s financial assets accounted for at fair value on a recurring basis as of December 31, 2021 and December 31, 2020, by level within the fair value hierarchy: (In thousands) Fair Value at Description December 31, 2021 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 9,868 $ 9,868 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 591 $ — $ 591 $ — Investment in convertible loan - AFS $ 268 $ — $ — $ 268 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 $ — $ — $ 5,576 Quantitative Information about Level 3 Fair Value Measurements Fair Value at Valuation Unobservable Description December 31, 2021 Techniques Input Average/Median Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 Discounted cash flow Discount rate 20%/20% (In thousands) Fair Value at Description December 31, 2020 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 9,309 $ 9,309 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 840 $ — $ 840 $ — Investment in convertible loan - AFS $ 83 $ — $ — $ 83 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 and October 23, 2021, respectively, the Company remeasured the investments in equity securities in Juventas to the fair value (see Note 3). The Company estimated the fair value of these securities based on the transaction price of similar securities issued by the investee. Quantitative Information about Level 3 Fair Value Measurements Fair Value at September 29, 2020 Description (remeasurement date) Valuation Techniques Unobservable Input Average/Median Investment in equity securities using measurement alternative $ 26,059 Market approach Multiples of selected comparable companies 5.3/1.1 Quantitative Information about Level 3 Fair Value Measurements Fair Value at October 23, 2021 Description (remeasurement date) Valuation Techniques Unobservable Input Average/Median Investment in equity securities using measurement alternative $ 32,308 Market approach Expected volatility 59%/58% On June 30, 2021, the Company remeasured the investment in equity securities in Alesta to the fair value of $1,385,000 (see Note 3). The Company estimated the fair value of the securities using Level 2 inputs based on the transaction price of identical securities issued by the investee. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis. 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. Assets held for sale were subsequently sold in July 2020 and October 2020, respectively. No impairment was recorded for the year ended December 31, 2021. The Company has no non-financial assets and liabilities that are measured at fair value on a non- recurring basis as of December 31, 2021. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | 20. RELATED PARTY TRANSACTIONS Juventas. BioCheck. Because the Company required additional office space, in January 2020, the agreement was amended for annualized rents in the amount of $144,000 ($12,000 a month) with a stipulation that the new rent was retroactive to October 1, 2019. The lease expired on June 9, 2021 and was not renewed. During the years ended December 31, 2021 and 2020, the Company recognized rent expense of $60,000 and $144,000, respectively. March 2021 Underwritten Public Offering Transactions ETP BioHealth III Fund LP (“ETP BioHealth”), in which CASI's Chairman and CEO is the founder and managing partner of ETP BioHealth’s general partner (Emerging Technology Partners, LLC (“ETP”)), purchased shares of common stock in the Offering at the public offering price and on the same terms as the other purchasers in the Offering. ETP BioHealth purchased 3,000,000 shares at the public offering price of $2.05 per share for a total of $6.15 million. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 21. COMMITMENTS AND CONTINGENCIES In conjunction with the Cleave agreement entered into during 2021 (see Note 1), the Company is responsible for certain milestone and royalty payments. As of December 31, 2021, no milestones have been achieved. In conjunction with the BioInvent agreement entered into during 2020 (see Note 1), the Company is responsible for certain milestone and royalty payments. As of December 31, 2021, no milestones have been achieved. In conjunction with the Black Belt agreement entered into during 2019 (see Note 1), the Company is responsible for certain milestone and royalty payments. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment in June 2021 and 250,000 euros ($305,000) in August 2021. As of December 31, 2021, no other milestones have been achieved. In conjunction with the Pharmathen agreement entered into during 2019 (see Note 1), the Company is responsible for one remaining milestone payment. As of December 31, 2021, the remaining milestone has not been achieved. 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 has committed to invest land use right and property, plant and equipment of RMB1 billion (equivalent to $143 million) by August 2022. In 2020, for the design and construction work of the land, CASI Wuxi entered into several contracts for RMB 76.1 million ($12.0 million) to complete the phase 1 project of CASI Wuxi's research and development production base, the project was the estimated to be completed in October 2023. In February 2022, the Company has reached an alignment with the Wuxi local government that it will collaborate with Wuxi LP to co-develop the land continuously in the future, and the original three-year investment plan will be extended, details regarding the plan are under negotiation. The commitment under these contracts was RMB 54.5 million ($8.5 million). Also in 2020, CASI Wuxi entered in to a lease agreement with local government for a manufactory building next to the leased land. Since then, the Company entered into a series of contracts for the remodeling and installation work of the building and warehouse, as well as purchase of equipments. The total contract amount entered into for this building is approximately RMB 92.9 million ($14.6 million), and the commitment under these contracts was RMB 14.6 million ($2.3 million). 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 EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 22. SUBSEQUENT EVENTS Renewal of Agreement with CRPCGIT In March 2019, the Company entered into a three-year exclusive distribution agreement with CRPCGIT to appoint CRPCGIT on an exclusive basis as its distributor to distribute EVOMELA ® |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Use of Estimates | Use of Estimates The preparation of 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 inventories, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments. 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. |
Consolidation | Consolidation The accompanying 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 China, CASI Wuxi, CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”), CASI Pharmaceuticals (Hainan) Co., Ltd. (“CASI Hainan”) and ZhongBio (Beijing) Tech Co. Ltd. ("ZhongBio”). CASI China is a 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 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. Accordingly, the financial statements of CASI Wuxi have been consolidated in the Company's consolidated financial statements since its inception. CASI Hainan and ZhongBio are wholly owned subsidiaries of CASI China and was established in June 2021 and September 2016, respectively. 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. |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The accompanying consolidated financial statements of the Company are reported in US dollars. The financial position and results of operations of the Company’s subsidiaries in the PRC are measured using the Renminbi (RMB), which is the local and functional currency of these entities. Assets and liabilities of the Company’s PRC subsidiaries are translated into US$ using the exchange rates in effect at the consolidated balance sheet date. The revenues and expenses of these entities are translated into US$ at the weighted average exchange rates for the period. The resulting translation gains (losses) are recorded in accumulated other comprehensive loss as a component of shareholders’ equity. Transactions denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Net gains or losses resulting from foreign currency denominated transactions are recorded in foreign exchange gain (losses) in the consolidated statements of operations and comprehensive loss. |
Revenue Recognition | Revenue Recognition Product sales recognized in the consolidated statements of operations and comprehensive loss are considered revenue from contracts with customers and, accordingly, 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 the Company satisfies a performance obligation. The Company recognizes revenue on sales of EVOMELA ® 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. There was no product exchange during the years ended December 31, 2021 and 2020. As of December 31, 2021 and 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 December 31, 2021 and 2020. |
Concentrations Risks | Concentrations Risks Cash Concentration Risk The Company maintains its U.S. and RMB cash in bank deposit accounts, which, at times, may exceed regulated insured limits. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. Vendor Concentration Risk The Company has a sole supplier for its EVOMELA ® ® Accounts Receivable and Credit Concentration CRPCGIT is the sole customer of the Company's EVOMELA ® The Company extends credit to CRPCGIT 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 were necessary as of December 31, 2021 and 2020. The balance of accounts receivable as of December 31, 2021 has been subsequently collected. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. 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. See Note 3 and Note 19 for additional fair value disclosures. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days that are readily convertible to known amounts of cash. |
Inventories | Inventories Inventories consist of EVOMELA ® |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are stated at cost, less accumulated depreciation and impairment, if any. Costs incurred in the construction of property, plant and equipment, including down payments and progress payments, are initially capitalized as construction-in-progress and transferred into their respective asset categories when the assets are ready for their intended use, at which time depreciation commences. Furniture and equipment are depreciated over their estimated useful lives of 3 to 5 years. Leasehold improvements are amortized over the shorter of their useful lives or the lease term. Depreciation and amortization expense are determined on a straight-line basis. |
Costs of Revenues | Costs of Revenues Costs of revenues consist primarily of the cost of inventories of EVOMELA ® ® |
Investments | Investments The Company’s investments consist of investments in equity securities with readily determinable fair value, equity securities without readily determinable fair value, and investments measured using fair value option. Investment in equity securities with readily determinable fair value are measured at fair values, and any changes in fair value are recognized in earnings. Where the fair value of an investment in equity securities is not readily determinable, the Company recognizes such investment in long-term investments, and uses the measurement alternative of 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. For equity investments measured at fair value with changes in fair value recorded in earnings, the Company does not assess whether those securities are impaired. For equity investments without readily determinable fair value, at each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. Impairment indicators that the Company considers include, but are not limited to, (i) the deterioration of earnings performance, credit rating, asset quality, or business prospects of the investee, (ii) a significant adverse change in the regulatory, economic, or technological environment of the investee, (iii) a significant adverse change in the general market condition of either the geographic area or the industry in which the investee operates. If a qualitative assessment indicates that the investment is impaired, the Company has to estimate the investment’s fair value and if the fair value is less than the investment’s carrying value, the Company recognizes an impairment loss in non-operating expenses equal to the difference between the carrying value and fair value. Dividend income is recognized in other income when earned. The Company elected to use fair value option to account for its investment in Cleave (see Note 3) as permitted under Accounting Standards Codification (“ASC”) 825, Financial Instruments (“ASC 825”), which then refers to ASC 820, Fair Value Measurement (“ASC 820”) to provide the fair value framework for valuing such investments. In accordance with ASC 820, the Company records such investment at fair value, with changes in fair value recorded in change in fair value of investments in the consolidated statements of operations and comprehensive loss. |
Leases | Leases At contract inception, the Company determines whether an arrangement is or contains a lease and whether the lease should be classified as an operating or a financing lease. A contract is or contains a lease if the contract conveys the right to control the use of the identified asset for a period of time in exchange for consideration. Control is determined based on the right to obtain all of the economic benefits from use of the identified asset and the right to direct the use of the identified asset. Right of use (“ROU”) assets for operating leases represent the right to use an underlying asset for the lease term, and operating lease liabilities represent the obligation to make lease payments. ROU assets and lease liabilities are recognized upon lease commencement for operating leases based on the present value of lease payments over the lease term. As the rate implicit in the lease cannot be readily determined, the Company uses incremental borrowing rate at the lease commencement date in determining the imputed interest and present value of lease payments. The incremental borrowing rate was determined based on the rate of interest that the Company would have to borrow an amount equal to the lease payments on a collateralized basis over a similar term. The incremental borrowing rate is primarily influenced by the risk-free interest rate of China and the US, the Company’s credit rating and lease term, and is updated for measurement of new lease liabilities. For operating leases, the Company recognizes a single lease cost on a straight-line basis over the remaining lease term. The Company has elected not to recognize ROU assets or lease liabilities for leases with an initial term of 12 months or less; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. In addition, the Company has elected not to separate non-lease components (e.g., common area maintenance fees) from the lease components. Land use rights acquired are recognized in right-of-use assets if they meet the definition of lease. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, including property, plant and equipment, operating lease right-of-use (“ROU”) assets and intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Such events and circumstances include the use of the asset or asset group in current research and development projects and any potential alternative future uses of the asset or asset group. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. Impairment charges related to intangible assets were $0 and $1.5 million for the years ended December 31, 2021 and 2020, respectively. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical testing and clinical trials of the Company’s product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses, along with the amortization of acquired ANDAs. Research and development costs are expensed as incurred. |
Acquired In-Process Research and Development Expense | Acquired In-Process Research and Development Expense The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under U.S. GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. The Company also pays contingent development milestone payments in accordance with agreements (see Note 1). The Company recognizes development milestone payments as acquired in-process research and development expenses when the milestones are reached. |
Stock-Based Compensation | Stock-Based Compensation The Company records compensation expense associated with service and performance-based stock options in accordance with provisions of authoritative guidance. The estimated fair value of service-based awards is measured on the grant date and is generally recognized on a straight-line basis over the requisite service period and based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. If the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation expense relating to those awards are reversed as occurred. Grant date fair value was determined using an option pricing model which is affected by the fair value of underlying ordinary shares as well as assumptions regarding a number of complex and subjective variables, such as expected volitality, expected term of options, risk-free rate, and expected dividend yield. |
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. |
Income Taxes | Income Taxes Income tax expense is recognized using the asset and liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities and operating loss and tax credit carryforwards as measured by the enacted tax rates that will be in effect when these differences reverse. A valuation allowance is provided to reduce the amount of deferred income tax assets if it is considered more likely than not that some portion or all of the deferred income tax assets will not be realized. The Company recognizes in its consolidated financial statements the impact of a tax position if a tax return position or future tax position is “more likely-than-not” to be sustained upon examination, based on the technical merits of the position. Tax positions that meet the “more-likely-than-not” recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. The Company recognizes interest and penalties related to uncertain tax positions, if any, in income tax expense. |
Net Loss Per Share | Net Loss Per Share Net loss per share (basic and diluted) was computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding. |
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. ASU 2018-13 eliminates, adds and modifies certain disclosure requirements for fair value measurements. The amendments applicable to the disclosures of changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial year of adoption. This ASU is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted, and an entity is also permitted to early adopt any removed or modified disclosures and delay adoption of the additional disclosures until their effective date. The Company adopted this guidance effective January 1, 2020. The adoption of this new accounting standard did not have a significant impact on the Company's consolidated financial statements. Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments to the initial guidance including ASU No. 2018-19, ASU No. 2019-04, and ASU No. 2019-05 (collectively, “Topic 326”). Topic 326 requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for public business entities, excluding entities eligible to be smaller reporting companies for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, this standard is effective for annual and interim periods beginning after December 15, 2022 and early adoption is permitted for annual and interim periods beginning after December 15, 2018. As a smaller reporting company, the Company expects to adopt this standard in fiscal year 2023. The Company is currently assessing the impact that the adoption of this ASU will have on the consolidated financial statements. There are no other recently issued accounting pronouncements that are expected to have a material effect on the Company’s financial position, results of operations or cash flows. |
INVESTMENT IN EQUITY SECURITI_2
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS | |
Schedule of investment | Gross (In thousands) unrealized Aggregate fair As of December 31, 2021 Classification Cost gains value MaxCyte - equity interest Investment $ — $ 3,866 $ 3,866 BioInvent - equity interest Investment $ 5,661 $ 341 $ 6,002 Total $ 9,868 Gross (In thousands) unrealized Aggregate fair As of December 31, 2020 Classification Cost gains value MaxCyte - equity interest Investment $ — $ 2,729 $ 2,729 BioInvent - equity interest Investment $ 5,661 $ 919 $ 6,580 Total $ 9,309 |
Schedule of components of long-term investments | Gross Foreign Gross unrealized currency As of December 31, 2021 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Alesta Therapeutics B.V. - convertible loan $ 261 $ 7 $ — $ — $ 268 Securities measured at fair value: BioInvent International AB - warrants 656 — (65) — 591 Cleave Therapeutics, Inc. - convertible loan 5,500 76 — — 5,576 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — (865) — 1,385 Juventas Cell Therapy Ltd - equity interests 23,500 6,958 — 1,850 32,308 Juventas Cell Therapy Ltd - put option 491 — (521) 30 — Total $ 32,658 $ 7,041 $ (1,451) $ 1,880 $ 40,128 Gross Foreign Gross unrealized currency As of December 31, 2020 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Black Belt Tx Limited - convertible loan $ 83 $ — $ — $ — $ 83 Securities measured at fair value: BioInvent International AB - warrants 656 184 — — 840 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — — — 2,250 Juventas Cell Therapy Ltd - equity interests 23,500 1,469 — 1,090 26,059 Juventas Cell Therapy Ltd - put option 491 — (306) 25 210 Total $ 26,980 $ 1,653 $ (306) $ 1,115 $ 29,442 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
LEASES | |
Schedule of right of use assets and liabilities on condensed balance sheet | December 31, December 31, (In thousands) 2021 2020 Right of use assets $ 9,107 $ 8,696 Accrued and other current liabilities $ 1,061 $ 939 Other liabilities 1,105 965 Total lease liabilities $ 2,166 $ 1,904 |
Schedule of supplemental cash flow information | Year Ended December 31, (In thousands) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,354 $ 1,375 Right of use assets obtained in exchange for lease obligations: $ 1,525 $ 1,196 |
Schedule of future undiscounted cash flows | (In thousands) 2022 $ 1,122 2023 774 2024 359 Total 2,255 Discount factor (89) Lease liability 2,166 Amounts due within 12 months 1,061 Non-current lease liability $ 1,105 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY, PLANT AND EQUIPMENT | |
Schedule of property and equipment | (In thousands) December 31, 2021 2020 Furniture and equipment $ 1,728 $ 1,622 Leasehold improvements 1,133 985 Construction in progress 12,095 1,193 Total property, plant and equipment, gross 14,956 3,800 Accumulated depreciation and amortization (1,817) (1,322) Impairment of property, plant and equipment (427) (416) $ 12,712 $ 2,062 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INTANGIBLE ASSETS | |
Schedule of net definite-lived intangible assets | Intangible assets at December 31, 2021 and 2020 consists of the following: (In thousands) Asset as of December 31, 2021 Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,832 $ (3,688) 13 years Others 197 (138) 5 years Total $ 16,029 $ (3,826) (In thousands) Asset as of December 31, 2020 Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,832 $ (2,721) 13 years Others 197 (98) 5 years Total $ 16,029 $ (2,819) |
Schedule of changes in intangible assets | (In thousands) 2021 2020 Balance at the beginning of the year $ 13,210 $ 13,674 Amortization expense (1,347) (1,289) Foreign currency translation adjustment 340 825 Balance at the ending of the year $ 12,203 $ 13,210 |
Schedule of expected future amortization expense | (In thousands) 2022 $ 1,351 2023 1,351 2024 1,323 2025 1,323 2026 1,323 2027 and thereafter 5,532 |
ACCRUED AND OTHER CURRENT LIA_2
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES | |
Schedule of accrued and other current liabilities and other liabilities | Year Ended December 31, (In thousands) 2021 2020 Accrued and other current liabilities: Payroll and welfare payable $ 3,336 $ 1,535 Payables related to property and equipment 3,288 467 Lease liabilities-current (Note 5) 1,061 939 Value-added tax and other tax payable 652 434 Other 60 49 $ 8,397 $ 3,424 Other Liabilites Profit-sharing liability to Juventas (Note 3) $ 13,220 $ 12,869 Lease liabilities-noncurrent (Note 5) 1,105 965 $ 14,325 $ 13,834 |
REDEEMABLE NONCONTROLLING INT_2
REDEEMABLE NONCONTROLLING INTEREST (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
REDEEMABLE NONCONTROLLING INTEREST | |
Schedule of changes in redeemable noncontrolling interest | Year Ended December 31, (In thousands) 2021 2020 Balance at beginning of period $ 22,033 $ 20,670 Share of CASI Wuxi net loss (700) (918) Accretion of redeemable noncontrolling interest 1,512 1,694 Foreign currency translation adjustment 612 587 Balance at end of period $ 23,457 $ 22,033 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
STOCKHOLDERS' EQUITY | |
Schedule of stock purchase warrants activity | Number of Weighted Average Warrants Exercise Price Outstanding at December 31, 2019 9,843,720 $ 4.43 Exercised (82,304) $ 1.69 Expired (1,489,707) $ 3.75 Outstanding at December 31, 2020 8,271,709 $ 4.58 Expired (2,098,877) $ 7.19 Outstanding at December 31, 2021 6,172,832 $ 3.69 Exercisable at December 31, 2021 6,172,832 $ 3.69 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
NET LOSS PER SHARE | |
Schedule of basic and diluted net loss per share | Year Ended December 31, (In thousands, except share and per share data) 2021 2020 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (36,654) $ (48,287) Denominator: Weighted average number of common stock 136,105,539 110,452,288 Denominator for basic and diluted net loss per share calculation 136,105,539 110,452,288 Net loss per share — Basic and diluted $ (0.27) $ (0.44) |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
STOCK-BASED COMPENSATION | |
Schedule of compensation expense | Year Ended December 31, (In thousands) 2021 2020 Research and development $ 361 $ 245 Sales and Marketing 449 39 General and administrative 6,960 7,537 Share-based compensation expense $ 7,770 $ 7,821 |
Schedule of weighted-average assumptions used in valuing the stock options | Year Ended December 31, 2021 2020 Expected volatility 79.68 % 78.70 % Range of expected volatility 75.69%-81.50 % 75.84% to 81.63 % Range of risk free interest rate 0.72%-1.38 % 0.31% to 1.77 % Expected term of option 6.17 years 6.10 years Expected dividend yield 0.00 % 0.00 % |
Schedule of stock option plans and of changes in options outstanding under the plans | Weighted Average Weighted Average Remaining Number of Options Exercise Price Contractual Term In Years Aggregate Intrinsic Value Outstanding at December 31, 2019 18,268,372 $ 2.58 Exercised (2,789,473) $ 1.39 $ 1,856,978 Granted 2,380,686 $ 2.71 Expired (117,722) $ 5.06 Forfeited (995,625) $ 3.78 Cancelled — $ — Outstanding at December 31, 2020 16,746,238 $ 2.71 Exercised — $ — $ — Granted 17,939,552 $ 1.49 Expired (387,000) $ 4.56 Forfeited (1,055,000) $ 2.64 Cancelled — $ — Outstanding at December 31, 2021 33,243,790 $ 2.04 7.71 $ — Vested and expected to vest at December 31, 2021 33,243,790 $ 2.04 7.71 $ — Exercisable at December 31, 2021 15,294,016 $ 2.44 5.81 $ — |
Schedule of stock options outstanding | The following summarizes information about stock options that are outstanding at December 31, 2021: Options Outstanding Options Exercisable Weighted Average Weighted Weighted Number Remaining Average Number Average Range of Outstanding at Contractual Exercise Exercisable at Exercise Exercise Prices December 31, 2021 Life in Years Price December 31, 2021 Price $0.00 - $1.00 3,223,853 7.66 $ 0.87 1,373,853 $ 0.87 $1.01 - $2.00 20,495,481 7.98 $ 1.52 6,158,707 $ 1.47 $2.01 - $4.00 8,209,456 7.25 $ 2.99 6,746,456 $ 2.94 $4.01 - $7.00 1,110,000 6.65 $ 6.82 810,000 $ 6.89 $7.01 - $9.00 205,000 6.50 $ 8.23 205,000 $ 8.23 33,243,790 7.71 $ 2.04 15,294,016 $ 2.44 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES | |
Schedule of domestic and foreign loss before income taxes | For financial reporting purposes, loss before income taxes includes the following components: (In thousands) 2021 2020 United States $ (32,169) $ (40,626) PRC (3,673) (6,885) Total $ (35,842) $ (47,511) |
Schedule of deferred income tax assets and liabilities | Significant components of the Company’s deferred income tax assets and liabilities as of December 31, 2021 and 2020 are as follows: December 31, (In thousands) 2021 2020 Deferred income tax assets: Net operating loss carryforwards $ 69,684 $ 78,790 Research and development credit carryforwards 4,259 6,244 Intangible assets 8,051 8,049 Stock-based compensation 5,336 5,126 Impairment loss of long-term investments 182 — Others 540 394 Valuation allowance for deferred income tax assets (83,651) (94,986) $ 4,401 $ 3,617 Deferred income tax liabilities: Deferred Royalty Income (2,342) (2,823) Change in fair value of investments (1,865) (690) Others (194) (104) $ (4,401) $ (3,617) |
Schedule of reconciliation of provision for income taxes to the federal statutory rate | A reconciliation of the provision for income taxes to the federal statutory rate is as follows: (In thousands) 2021 2020 Tax benefit at statutory rate of 21% $ (7,526) $ (9,977) State taxes — (732) Attribute expiration 10,676 13,707 Change in applicable tax rates 7,117 11,612 Nondeductible expenses 1,059 358 Deemed royalty — 4,220 Others 9 (54) Change in valuation allowance (11,335) (19,134) $ — $ — |
Schedule of reconciliation of gross unrecognized tax benefits | A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: (In thousands) 2021 2020 Unrecognized tax benefits balance at January 1 $ 2,082 $ 2,581 Reductions for tax positions of prior periods (642) (499) Additions for tax positions of current period — — Unrecognized tax benefits balance at December 31 $ 1,440 $ 2,082 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Schedule of assets and liabilities measured at fair value on recurring and nonrecurring basis | (In thousands) Fair Value at Description December 31, 2021 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 9,868 $ 9,868 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 591 $ — $ 591 $ — Investment in convertible loan - AFS $ 268 $ — $ — $ 268 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 $ — $ — $ 5,576 Quantitative Information about Level 3 Fair Value Measurements Fair Value at Valuation Unobservable Description December 31, 2021 Techniques Input Average/Median Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 Discounted cash flow Discount rate 20%/20% (In thousands) Fair Value at Description December 31, 2020 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 9,309 $ 9,309 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 840 $ — $ 840 $ — Investment in convertible loan - AFS $ 83 $ — $ — $ 83 |
Non-recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Schedule of quantitative information about level 3 fair value measurements | Quantitative Information about Level 3 Fair Value Measurements Fair Value at September 29, 2020 Description (remeasurement date) Valuation Techniques Unobservable Input Average/Median Investment in equity securities using measurement alternative $ 26,059 Market approach Multiples of selected comparable companies 5.3/1.1 Quantitative Information about Level 3 Fair Value Measurements Fair Value at October 23, 2021 Description (remeasurement date) Valuation Techniques Unobservable Input Average/Median Investment in equity securities using measurement alternative $ 32,308 Market approach Expected volatility 59%/58% |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details) ¥ in Millions | Oct. 29, 2019 | Mar. 31, 2022 | Nov. 30, 2021USD ($) | Nov. 30, 2021CNY (¥) | Aug. 31, 2021USD ($) | Aug. 31, 2021EUR (€) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Nov. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2020CNY (¥) | Apr. 30, 2020USD ($) | Apr. 30, 2020CNY (¥) | Apr. 30, 2019USD ($) | Apr. 30, 2019EUR (€) | Mar. 31, 2019 | Dec. 31, 2021USD ($) | Dec. 31, 2021CNY (¥) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2019EUR (€) | Dec. 31, 2021USD ($) | Dec. 31, 2021CNY (¥) | Dec. 31, 2020CNY (¥) | Nov. 30, 2019USD ($) | Nov. 30, 2019CNY (¥) |
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Payables related to property and equipment | $ 3,288,000 | $ 467,000 | $ 3,288,000 | |||||||||||||||||||||||
Accumulated deficit | (605,643,000) | (570,501,000) | (605,643,000) | |||||||||||||||||||||||
Cash and cash equivalents | 38,704,000 | 57,064,000 | 38,704,000 | |||||||||||||||||||||||
Revenues | 30,168,000 | 15,141,000 | ||||||||||||||||||||||||
Acquired in-process research and development | 6,555,000 | 17,828,000 | ||||||||||||||||||||||||
Cleave Therapeutics, Inc | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Upfront payment | $ 5,500,000 | |||||||||||||||||||||||||
Acquired in-process research and development | 5,500,000 | |||||||||||||||||||||||||
BioInvent International AB | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Upfront payment | $ 5,900,000 | |||||||||||||||||||||||||
Acquired in-process research and development | 5,900,000 | |||||||||||||||||||||||||
Black Belt Therapeutics Ltd | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Milestone payment | $ 305,000 | € 250,000 | $ 750,000 | |||||||||||||||||||||||
Upfront payment | $ 5,700,000 | € 5,000,000 | ||||||||||||||||||||||||
Potential milestones and royalties of up to | $ 46,300,000 | |||||||||||||||||||||||||
In-process research and development expensed | $ 1,100,000 | |||||||||||||||||||||||||
Pharmathen Global BV | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Upfront payment | € | € 1,000,000 | |||||||||||||||||||||||||
Additional milestone payments paid | 1,700,000 | € 1,500,000 | ||||||||||||||||||||||||
Non royalty exclusive distribution period | 10 years | 10 years | ||||||||||||||||||||||||
Non-royalty exclusive distribution period at agreed cost | 3 years | |||||||||||||||||||||||||
China Resources Guokang Pharmaceuticals Co., Ltd | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Revenues | $ 30,000,000 | 15,000,000 | ||||||||||||||||||||||||
Non royalty exclusive distribution period | 3 years | |||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Milestone payment | $ 10,000,000 | ¥ 70 | ||||||||||||||||||||||||
Riemser Pharma GmbH | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Contingent milestone payment | 0 | 0 | ||||||||||||||||||||||||
License Agreement Terms | Black Belt Therapeutics Ltd | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Upfront payment | € | € 5,000,000 | |||||||||||||||||||||||||
Subsequent Events. | China Resources Guokang Pharmaceuticals Co., Ltd | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Non royalty exclusive distribution additional period | 2 years | |||||||||||||||||||||||||
Maximum | Cleave Therapeutics, Inc | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Milestone payment | $ 74,000,000 | |||||||||||||||||||||||||
Maximum | BioInvent International AB | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Potential milestones and royalties of up to | $ 83,000,000 | |||||||||||||||||||||||||
Maximum | Pharmathen Global BV | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Additional milestone payments paid | € | € 2,000,000 | |||||||||||||||||||||||||
CASI China | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Cash and cash equivalents | $ 19,300,000 | 19,300,000 | ||||||||||||||||||||||||
CASI Wuxi | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Term of lease contract | 50 years | 50 years | ||||||||||||||||||||||||
Investment committed | $ 143,000,000 | ¥ 1,000 | ||||||||||||||||||||||||
Government grant received | $ 500,000 | ¥ 3 | $ 2,200,000 | ¥ 15.9 | ||||||||||||||||||||||
Contractual Obligation | $ 12,000,000 | ¥ 76.1 | ||||||||||||||||||||||||
CASI Wuxi | Contracts for the design and construction work of the land | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Total contract amount | 12,000,000 | ¥ 76.1 | ||||||||||||||||||||||||
CASI Wuxi | Contracts for the remodeling and installation work of the building and warehouse | ||||||||||||||||||||||||||
Description of Business and Basis of Presentation | ||||||||||||||||||||||||||
Total contract amount | ¥ 92.9 | $ 14,600,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Consolidation (Details) | 12 Months Ended |
Dec. 31, 2021segment | |
Percentage of ownership interest held by the parent entity in the non stock subsidiary | 100.00% |
Number of operating segments | 1 |
CASI Wuxi | |
Percentage of ownership interest held by the parent entity in the non stock subsidiary | 80.00% |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentrations of Risk (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - PPE (Details) - Furniture and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Minimum | |
Property, Plant and Equipment | |
Estimated useful life | 3 years |
Maximum | |
Property, Plant and Equipment | |
Estimated useful life | 5 years |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Impairment of Long-Lived Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Impairment of intangible assets | $ 1,537 | $ 0 | $ 1,500 |
INVESTMENT IN EQUITY SECURITI_3
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS - Summary of Investments (Details) - Common Stock - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity securities at fair value | $ 9,868 | $ 9,309 |
MaxCyte Inc. | ||
Gross unrealized gains. | 3,866 | 2,729 |
Equity securities at fair value | 3,866 | 2,729 |
BioInvent International AB | ||
Cost | 5,661 | 5,661 |
Gross unrealized gains. | 341 | 919 |
Equity securities at fair value | $ 6,002 | $ 6,580 |
INVESTMENT IN EQUITY SECURITI_4
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS - Summary of Long-term investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule Of Long Term Investments | ||
Cost | $ 32,658 | $ 26,980 |
Gross unrealized gains | 7,041 | 1,653 |
Gross unrealized losses (including impairment) | (1,451) | (306) |
Foreign currency translation adjustment | 1,880 | 1,115 |
Aggregate fair value | 40,128 | 29,442 |
Alesta Tx | Available-for-sale debt securities | Convertible loan | ||
Schedule Of Long Term Investments | ||
Cost | 261 | |
Gross unrealized gains | 7 | |
Aggregate fair value | 268 | |
Alesta Tx | Equity securities without readily determinable fair value | Equity Securities | ||
Schedule Of Long Term Investments | ||
Cost | 2,250 | 2,250 |
Gross unrealized losses (including impairment) | (865) | |
Aggregate fair value | 1,385 | 2,250 |
Black Belt Tx Limited | Available-for-sale debt securities | Convertible loan | ||
Schedule Of Long Term Investments | ||
Cost | 83 | |
Aggregate fair value | 83 | |
Juventas Cell Therapy Ltd. | Equity securities without readily determinable fair value | Equity Securities | ||
Schedule Of Long Term Investments | ||
Cost | 23,500 | 23,500 |
Gross unrealized gains | 6,958 | 1,469 |
Foreign currency translation adjustment | 1,850 | 1,090 |
Aggregate fair value | 32,308 | 26,059 |
Juventas Cell Therapy Ltd. | Equity securities without readily determinable fair value | Put option | ||
Schedule Of Long Term Investments | ||
Cost | 491 | 491 |
Gross unrealized losses (including impairment) | (521) | (306) |
Foreign currency translation adjustment | 30 | 25 |
Aggregate fair value | 210 | |
BioInvent International AB | Securities measured at fair value | Warrants | ||
Schedule Of Long Term Investments | ||
Cost | 656 | 656 |
Gross unrealized gains | 184 | |
Gross unrealized losses (including impairment) | (65) | |
Aggregate fair value | 591 | $ 840 |
Cleave Therapeutics, Inc | Securities measured at fair value | Convertible loan | ||
Schedule Of Long Term Investments | ||
Cost | 5,500 | |
Gross unrealized gains | 76 | |
Aggregate fair value | $ 5,576 |
INVESTMENT IN EQUITY SECURITI_5
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS (Details) kr in Millions | Oct. 26, 2021USD ($) | Oct. 26, 2021CNY (¥) | Sep. 29, 2020USD ($) | Sep. 29, 2020CNY (¥) | Jul. 31, 2021USD ($) | Jul. 31, 2021EUR (€) | Mar. 31, 2021USD ($) | Feb. 28, 2021USD ($) | Feb. 28, 2021EUR (€) | Nov. 30, 2020USD ($) | Oct. 31, 2020USD ($)shares | Sep. 30, 2020 | Aug. 31, 2020USD ($) | Aug. 31, 2020EUR (€) | Aug. 31, 2020CNY (¥) | Jul. 31, 2020USD ($) | Jul. 31, 2020EUR (€) | Jun. 30, 2020USD ($) | Jun. 30, 2020CNY (¥) | Jun. 30, 2019USD ($) | Jun. 30, 2019CNY (¥) | Apr. 30, 2019USD ($) | Apr. 30, 2019EUR (€) | Dec. 31, 2021USD ($) | Dec. 31, 2021CNY (¥) | Dec. 31, 2020USD ($)loan | Oct. 26, 2021EUR (€) | Oct. 26, 2021CNY (¥) | Jul. 31, 2021EUR (€) | Oct. 31, 2020SEK (kr) | Sep. 29, 2020CNY (¥) | Jul. 31, 2020EUR (€) |
Number of loans | loan | 2 | |||||||||||||||||||||||||||||||
Loan to related party | $ 10,033,000 | |||||||||||||||||||||||||||||||
Unrealized gains | $ 1,100,000 | 3,000,000 | ||||||||||||||||||||||||||||||
Unrealized losses | 600,000 | 0 | ||||||||||||||||||||||||||||||
BioInvent International AB | ||||||||||||||||||||||||||||||||
Investment to be made | $ 6,300,000 | kr 53.8 | ||||||||||||||||||||||||||||||
Number of shares subscribed (in shares) | shares | 1,200,000 | |||||||||||||||||||||||||||||||
Reverse stock split | 25 | |||||||||||||||||||||||||||||||
Number of new warrants subscribed | shares | 14,700,000 | |||||||||||||||||||||||||||||||
Number of shares subscribed per warrant | 0.04 | 0.04 | ||||||||||||||||||||||||||||||
Subscription period for warrants | 5 years | |||||||||||||||||||||||||||||||
Fair value of warrants outstanding | $ 591,000 | $ 840,000 | ||||||||||||||||||||||||||||||
Warrants expected life | 3 years 10 months 28 days | 4 years 10 months 28 days | ||||||||||||||||||||||||||||||
Unrealized gains | $ 180,000 | |||||||||||||||||||||||||||||||
Unrealized losses | $ 250,000 | |||||||||||||||||||||||||||||||
Upfront payment | $ 5,900,000 | |||||||||||||||||||||||||||||||
BioInvent International AB | Expected volatility | ||||||||||||||||||||||||||||||||
Warrants , Measurement Input | 46.32 | 47.63 | ||||||||||||||||||||||||||||||
BioInvent International AB | Risk Free Interest Rate | ||||||||||||||||||||||||||||||||
Warrants , Measurement Input | 0.07 | 0.36 | ||||||||||||||||||||||||||||||
Alesta Tx | ||||||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 1,385,000 | |||||||||||||||||||||||||||||||
Equity ownership (as a percent) | 14.10% | 14.10% | ||||||||||||||||||||||||||||||
Percentage of fully diluted capital | 8.30% | |||||||||||||||||||||||||||||||
Loan amount | $ 261,000 | € 217,166 | ||||||||||||||||||||||||||||||
Interest rate (as a percent) | 6.00% | 6.00% | ||||||||||||||||||||||||||||||
Impairment of equity investment | $ 865,000 | |||||||||||||||||||||||||||||||
Contribution amount | € | 750,000 | |||||||||||||||||||||||||||||||
Exchange of common stocks | € | € 770,270 | |||||||||||||||||||||||||||||||
Alesta Tx | Minimum | ||||||||||||||||||||||||||||||||
Equity ownership (as a percent) | 12.90% | |||||||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | ||||||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 32,300,000 | $ 12,300,000 | € 0 | ¥ 205,600,000 | ¥ 83,700,000 | |||||||||||||||||||||||||||
Payments to acquire equity Investments | $ 11,788,000 | ¥ 80,000,000 | ||||||||||||||||||||||||||||||
Equity ownership (as a percent) | 12.01% | 16.45% | 16.327% | 16.327% | 12.01% | 12.01% | ||||||||||||||||||||||||||
Proceeds from fund raising | $ 63,000,000 | ¥ 410,000,000 | ||||||||||||||||||||||||||||||
Interest rate (as a percent) | 8.00% | 8.00% | 8.00% | |||||||||||||||||||||||||||||
Additional equity investment | ¥ | ¥ 70,000,000 | |||||||||||||||||||||||||||||||
Change in fair value of investment in equity securities | $ 5,500,000 | ¥ 35,200,000 | $ 1,116,000 | |||||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | June 2020 Loan Agreement | ||||||||||||||||||||||||||||||||
Term of loan provided | 1 year | 1 year | ||||||||||||||||||||||||||||||
Interest income from related party | 351,000 | |||||||||||||||||||||||||||||||
Interest rate (as a percent) | 20.00% | 20.00% | ||||||||||||||||||||||||||||||
Loans advanced to related party | $ 4,243,000 | ¥ 30,000,000 | ||||||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | August 2020 Loan Agreement | ||||||||||||||||||||||||||||||||
Term of loan provided | 1 year | 1 year | 1 year | |||||||||||||||||||||||||||||
Interest income from related party | 375,000 | |||||||||||||||||||||||||||||||
Interest rate (as a percent) | 20.00% | 20.00% | 20.00% | |||||||||||||||||||||||||||||
Loans advanced to related party | $ 5,790,000 | ¥ 40,000,000 | ||||||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | Put option | ||||||||||||||||||||||||||||||||
Payments to acquire equity Investments | $ 64,000 | ¥ 400,000 | ||||||||||||||||||||||||||||||
Change in fair value of investment in equity securities | 200,000 | ¥ 1,400,000 | ||||||||||||||||||||||||||||||
Black Belt Tx Limited | ||||||||||||||||||||||||||||||||
Payments to acquire equity Investments | $ 2,249,600 | € 2,000,000 | ||||||||||||||||||||||||||||||
Convertible loan tranches repaid | € | € 70,600 | |||||||||||||||||||||||||||||||
Minimum equity financing | $ 5,900,000 | € 5,000,000 | ||||||||||||||||||||||||||||||
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% | 14.10% | 14.10% | ||||||||||||||||||||||||||||
Interest rate (as a percent) | 6.00% | 6.00% | ||||||||||||||||||||||||||||||
Term of loan | 3 years | 3 years | 3 years | 3 years | ||||||||||||||||||||||||||||
Loan to be advanced | $ 250,000 | € 211,800 | ||||||||||||||||||||||||||||||
Convertible loan repaid | $ 172,000 | € 146,566 | ||||||||||||||||||||||||||||||
Black Belt Tx Limited | Black Belt Tx Loan - Tranche One | ||||||||||||||||||||||||||||||||
Convertible loan tranches repaid | 83,000 | 70,600 | $ 83,000 | € 70,600 | ||||||||||||||||||||||||||||
Black Belt Tx Limited | Black Belt Tx Loan - Tranche Two | ||||||||||||||||||||||||||||||||
Convertible loan tranches repaid | 83,000 | 70,600 | $ 86,000 | € 70,600 | ||||||||||||||||||||||||||||
Convertible loan interest repaid | $ 6,000 | € 5,366 | ||||||||||||||||||||||||||||||
Cleave Therapeutics, Inc | ||||||||||||||||||||||||||||||||
Term of loan provided | 3 years | |||||||||||||||||||||||||||||||
Interest rate (as a percent) | 3.00% | |||||||||||||||||||||||||||||||
Change in fair value of investment in equity securities | 76,000 | |||||||||||||||||||||||||||||||
Minimum equity financing round amount | $ 10,000,000 | |||||||||||||||||||||||||||||||
Percentage of per share price at which the loans advanced will be converted | 80.00% | |||||||||||||||||||||||||||||||
Upfront payment | $ 5,500,000 | |||||||||||||||||||||||||||||||
Investment in Convertible Note | $ 5,500,000 | |||||||||||||||||||||||||||||||
Level 1 | MaxCyte Inc. | ||||||||||||||||||||||||||||||||
Fair value of additional equity interest | 3,900,000 | 2,700,000 | ||||||||||||||||||||||||||||||
Level 1 | BioInvent International AB | ||||||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 6,000,000 | $ 6,600,000 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INVENTORIES | ||
Finished goods | $ 1,900 | $ 1,400 |
Inventory write down | $ 0 | $ 0 |
LEASES - (Details)
LEASES - (Details) ¥ in Millions | 12 Months Ended | ||||
Dec. 31, 2021USD ($)lease | Dec. 31, 2020USD ($)lease | Dec. 31, 2019USD ($) | Dec. 31, 2019CNY (¥) | Nov. 30, 2019m² | |
Rent expenses | $ 1,452,000 | $ 1,600,000 | |||
Number of operating lease | lease | 8 | 7 | |||
Weighted average remaining lease term | 36 years 5 months 19 days | 38 years 4 months 13 days | |||
Weighted average discount rates | 3.56% | 3.72% | |||
Variable lease costs | $ 0 | $ 0 | |||
Sublease income | $ 0 | $ 0 | |||
CASI Wuxi | |||||
Term of lease contract | 50 years | ||||
Land parcel area (in square meters) | m² | 74,028.40 | ||||
Prepaid lease payments for the land use right | $ 6,500,000 | ¥ 45 |
LEASES - Right of Use Assets an
LEASES - Right of Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Right of use assets | $ 9,107 | $ 8,696 |
Operating Lease, Liability | $ 2,166 | $ 1,904 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Right of use assets | Right of use assets |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued And Other Liabilities, Current | Accrued And Other Liabilities, Current |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent, Other Liabilities, Noncurrent | us-gaap:AccruedLiabilitiesCurrent, Other Liabilities, Noncurrent |
Accrued Liabilities-Current | ||
Operating Lease, Liability | $ 1,061 | $ 939 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued And Other Liabilities, Current | Accrued And Other Liabilities, Current |
Other Liabilities-Long Term | ||
Operating Lease, Liability | $ 1,105 | $ 965 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
LEASES - Supplemental Cash Flow
LEASES - Supplemental Cash Flow (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows | $ 1,354 | $ 1,375 |
Right of use assets obtained in exchange for lease obligations | $ 1,525 | $ 1,196 |
LEASES - Future Undiscounted Ca
LEASES - Future Undiscounted Cash Flows (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
LEASES | ||
2022 | $ 1,122 | |
2023 | 774 | |
2024 | 359 | |
Total | 2,255 | |
Discount factor | (89) | |
Lease liability | 2,166 | $ 1,904 |
Amounts due within 12 months | 1,061 | 939 |
Non-current lease liability | $ 1,105 | $ 965 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
PROPERTY, PLANT AND EQUIPMENT | ||
Furniture and equipment | $ 1,728 | $ 1,622 |
Leasehold improvements | 1,133 | 985 |
Construction in progress | 12,095 | 1,193 |
Total property, plant and equipment, gross | 14,956 | 3,800 |
Accumulated depreciation and amortization | (1,817) | (1,322) |
Impairment of property, plant and equipment | (427) | (416) |
Total property, plant and equipment, net | $ 12,712 | $ 2,062 |
PROPERTY, PLANT AND EQUIPMENT -
PROPERTY, PLANT AND EQUIPMENT - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Construction in progress | $ 12,095,000 | $ 1,193,000 |
Depreciation expense | 468,000 | 562,000 |
Impairment of property, plant and equipment | $ 0 | $ 0 |
Furniture and Equipment | Maximum | ||
Estimated useful life | 5 years | |
Furniture and Equipment | Minimum | ||
Estimated useful life | 3 years |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) | 1 Months Ended | 12 Months Ended | ||
Feb. 29, 2020USD ($)item | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Finite-Lived Intangible Assets | ||||
Net book value | $ 12,203,000 | $ 13,210,000 | $ 13,674,000 | |
Gain (Loss) | $ 450,000 | $ 1,152,000 | ||
ANDA | ||||
Finite-Lived Intangible Assets | ||||
Estimated useful lives | 13 years | 13 years | ||
Cloud Computing Arrangement | ||||
Finite-Lived Intangible Assets | ||||
Estimated useful lives | 5 years | |||
Chartwell | ANDA | ||||
Finite-Lived Intangible Assets | ||||
Number of intangible assets sold | 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 |
INTANGIBLE ASSETS - Net Definit
INTANGIBLE ASSETS - Net Definite-lived Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets | ||
Purchase Price | $ 16,029 | $ 16,029 |
Accumulated Amortization | (3,826) | (2,819) |
ANDA | ||
Finite-Lived Intangible Assets | ||
Purchase Price | 15,832 | 15,832 |
Accumulated Amortization | $ (3,688) | $ (2,721) |
Estimated useful lives | 13 years | 13 years |
Others | ||
Finite-Lived Intangible Assets | ||
Purchase Price | $ 197 | $ 197 |
Accumulated Amortization | $ (138) | $ (98) |
Estimated useful lives | 5 years | 5 years |
INTANGIBLE ASSETS - Intangible
INTANGIBLE ASSETS - Intangible Assets Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INTANGIBLE ASSETS | ||
Beginning balance | $ 13,210 | $ 13,674 |
Amortization expenses | (1,347) | (1,289) |
Foreign currency translation adjustments | (340) | (825) |
Ending balance | $ 12,203 | $ 13,210 |
INTANGIBLE ASSETS - Expected Fu
INTANGIBLE ASSETS - Expected Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2021USD ($) |
INTANGIBLE ASSETS | |
2022 | $ 1,351 |
2023 | 1,351 |
2024 | 1,323 |
2025 | 1,323 |
2026 | 1,323 |
2027 and thereafter | $ 5,532 |
ACCRUED AND OTHER CURRENT LIA_3
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
ACCRUED AND OTHER CURRENT LIABILITIES, AND OTHER LIABILITIES | ||
Payroll and welfare payable | $ 3,336 | $ 1,535 |
Payables related to property and equipment | 3,288 | 467 |
Lease liabilities-current (Note 5) | $ 1,061 | $ 939 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued and other current liabilities | Accrued and other current liabilities |
Value-added tax and other tax payable | $ 652 | $ 434 |
Other | 60 | 49 |
Accrued and other current liabilities | 8,397 | 3,424 |
Profit-sharing liability to Juventas (Note 3) | 13,220 | 12,869 |
Lease liabilities-noncurrent (Note 5) | $ 1,105 | $ 965 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities | Other Liabilities |
Other Liabilities | $ 14,325 | $ 13,834 |
BANK BORROWINGS (Details)
BANK BORROWINGS (Details) ¥ in Millions | Feb. 03, 2021USD ($) | Feb. 03, 2021CNY (¥) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020CNY (¥) | Nov. 03, 2020USD ($) | Nov. 03, 2020CNY (¥) |
Bank Borrowings | |||||||
Amount matured | $ 709,000 | $ 783,000 | |||||
Interest expense | 2,900 | 3,100 | |||||
China CITIC Bank Corporation Limited | |||||||
Bank Borrowings | |||||||
Maximum Borrowing | $ 1,500,000 | ¥ 10 | |||||
Amount outstanding | $ 800,000 | ¥ 5.4 | |||||
Interest rate | 3.72% | 3.72% | 3.35% | 3.35% | |||
Amount matured | $ 700,000 | ¥ 4.6 | |||||
Interest expense | $ 41,000 | $ 1,000 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) ¥ in Millions | Apr. 29, 2020 | Sep. 30, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Feb. 03, 2021 | Nov. 03, 2020CNY (¥) | Nov. 03, 2020USD ($) | Apr. 27, 2020USD ($) |
Notes Payable | ||||||||
Interest expense | $ 2,900 | $ 3,100 | ||||||
Notes payable forgiven | $ 465,595 | |||||||
Loan interest forgiven | $ 6,212 | |||||||
M & T Bank | ||||||||
Notes Payable | ||||||||
Loan approved under Paycheck Protection Program (PPP) | $ 465,595 | |||||||
Interest rate | 1.00% | |||||||
Term of loan | 2 years | |||||||
China CITIC Bank Corporation Limited | ||||||||
Notes Payable | ||||||||
Loan approved under Paycheck Protection Program (PPP) | ¥ 10 | $ 1,500,000 | ||||||
Interest rate | 3.35% | 3.72% | ||||||
Interest expense | $ 41,000 | $ 1,000 |
GRANTS (Details)
GRANTS (Details) ¥ in Millions | 1 Months Ended | 12 Months Ended | ||||||
Nov. 30, 2021CNY (¥) | Nov. 30, 2021USD ($) | Apr. 30, 2020CNY (¥) | Apr. 30, 2020USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Nov. 30, 2019CNY (¥) | Nov. 30, 2019USD ($) | |
Grants | ||||||||
Other income | $ 51,000 | $ 35,000 | ||||||
CASI Wuxi | ||||||||
Grants | ||||||||
Term of lease contract | 50 years | 50 years | ||||||
Amount of grants eligible | ¥ 25 | $ 3,600,000 | ||||||
Government grant received | ¥ 3 | $ 500,000 | ¥ 15.9 | $ 2,200,000 |
REDEEMABLE NONCONTROLLING INT_3
REDEEMABLE NONCONTROLLING INTEREST (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
May 31, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2021USD ($)installment | Feb. 28, 2019USD ($) | Dec. 26, 2018USD ($) | |
Noncontrolling Interest | |||||
Value of transfer of selected ANDAs | $ 30 | ||||
CASI Wuxi | |||||
Noncontrolling Interest | |||||
Equity ownership (as a percent) | 80.00% | ||||
Investment commitment | $ 80 | ||||
Initial cash investment | $ 21 | ||||
Value of transfer of selected ANDAs | $ 30 | ||||
Committed amount of cash payment within three years | $ 29 | ||||
Call option purchase investment period | 5 years | ||||
Payments to acquire investments | $ 20 | $ 20 | |||
Number of installments | installment | 3 | ||||
Payment made in July 2021 | $ 10 | ||||
Payments to be made in 2022 | 10 | ||||
Payments to be made in 2023 | $ 9 | ||||
CASI Wuxi | Call Option | |||||
Noncontrolling Interest | |||||
Equity ownership (as a percent) | 20.00% | 20.00% | |||
CASI Wuxi | Put option | |||||
Noncontrolling Interest | |||||
Equity ownership (as a percent) | 20.00% | ||||
CASI Wuxi | |||||
Noncontrolling Interest | |||||
Payments to acquire investments | $ 20 |
REDEEMABLE NONCONTROLLING INT_4
REDEEMABLE NONCONTROLLING INTEREST - Changes in Redeemable Noncontrolling Interest (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
REDEEMABLE NONCONTROLLING INTEREST | ||
Balance at beginning of period | $ 22,033 | $ 20,670 |
Share of CASI Wuxi net loss | (700) | (918) |
Accretion of redeemable noncontrolling interest | (1,512) | (1,694) |
Foreign currency translation adjustment | 612 | 587 |
Balance at end of period | $ 23,457 | $ 22,033 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | Mar. 18, 2022 | Mar. 24, 2021 | Jul. 24, 2020 | Jul. 19, 2019 | Feb. 23, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 15, 2021 | Oct. 29, 2021 |
Shares issued | 15,853,658 | 23,000,000 | 493,000 | ||||||||
Net proceeds from issuance of common stock | $ 32,500,000 | $ 1,539,000 | |||||||||
Offering price per share | $ 2.05 | ||||||||||
Gross proceeds from the offering | $ 43,700,000 | ||||||||||
Common Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 | |||||||||
Subsequent Events. | |||||||||||
Shares repurchased | 3,207,661 | ||||||||||
Amount of shares repurchased | $ 2,500,000 | ||||||||||
Maximum | |||||||||||
Stock Repurchase Program, Authorized Amount | $ 10,000,000 | ||||||||||
Stock Repurchase Program, Number of Shares Authorized to be Repurchased | 12,500,000 | ||||||||||
ETP Global Fund LP | |||||||||||
Shares issued | 1,200,000 | ||||||||||
Chairman And CEO | |||||||||||
Shares issued | 2,952,426 | ||||||||||
President | |||||||||||
Shares issued | 20,152 | ||||||||||
Sales Agreement | |||||||||||
Shares issued | 143,248 | ||||||||||
Net proceeds from issuance of common stock | $ 475,000 | ||||||||||
Open Market Sale Agreement | |||||||||||
Shares issued | 434,000 | 59,000 | |||||||||
Net proceeds from issuance of common stock | $ 1,357,000 | $ 182,000 | |||||||||
Maximum Sales Price from Issuance of Common Stock | $ 30,000,000 | ||||||||||
Remaining amount available under the sales agreement | $ 28,500,000 | ||||||||||
Stock Sale Agreement | H.C. Wainwright Co., LLC | |||||||||||
Public offering price | $ 20,000,000 | ||||||||||
Public Offering Price | $ 20,000,000 | ||||||||||
Amendment To Open Sale Agreement | |||||||||||
Maximum Sales Price from Issuance of Common Stock | $ 20,000,000 | ||||||||||
Oppenheimer & Co. Inc. | |||||||||||
Offering price per share | $ 2.05 | ||||||||||
Additional shares of common stock purchase | 15,853,658 |
STOCKHOLDERS' EQUITY - Warrants
STOCKHOLDERS' EQUITY - Warrants Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Warrants | ||
Beginning balance | 8,271,709 | 9,843,720 |
Exercised | (82,304) | |
Expired | (2,098,877) | (1,489,707) |
Ending balance | 6,172,832 | 8,271,709 |
Exercisable | 6,172,832 | |
Weighted Average Exercise Price | ||
Beginning balance | $ 4.58 | $ 4.43 |
Exercised | 1.69 | |
Expired | 7.19 | 3.75 |
Ending balance | 3.69 | $ 4.58 |
Exercisable | $ 3.69 |
COSTS OF REVENUES (Details)
COSTS OF REVENUES (Details) - EVOMELA | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |
Percentage of royalties required to be paid | 20.00% |
The period royalties are required to be paid (in years) | 10 years |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||
Antidilutive securities excluded from computation of earnings per share amount | 33,243,790 | 16,746,238 |
Warrant | ||
Antidilutive securities excluded from computation of earnings per share amount | 6,172,832 | 8,271,709 |
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 | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator: | ||
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (36,654) | $ (48,287) |
Denominator: | ||
Weighted average number of common shares | 136,105,539 | 110,452,288 |
Denominator for basic and diluted net loss per share calculation | 136,105,539 | 110,452,288 |
Net loss per share (basic) | $ (0.27) | $ (0.44) |
Net loss per share (diluted) | $ (0.27) | $ (0.44) |
EMPLOYEE BENEFIT PLAN (Details)
EMPLOYEE BENEFIT PLAN (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
EMPLOYEE BENEFIT PLAN | ||
Employer contributions | $ 187,000 | $ 250,000 |
Defined contribution plan expenses | $ 3,137,000 | $ 1,542,000 |
STOCK-BASED COMPENSATION - Comp
STOCK-BASED COMPENSATION - Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 7,770 | $ 7,821 |
Research and Development Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 361 | 245 |
Sales and Marketing | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 449 | 39 |
General and Administrative Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 6,960 | $ 7,537 |
STOCK-BASED COMPENSATION - Weig
STOCK-BASED COMPENSATION - Weighted-Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
STOCK-BASED COMPENSATION | ||
Expected volatility | 79.68% | 78.70% |
Range of expected volatility, Minimum | 75.69% | 75.84% |
Range of expected volatility, Maximum | 81.50% | 81.63% |
Range of risk free interest rate, Minimum | 0.72% | 0.31% |
Range of risk free interest rate, Maximum | 1.38% | 1.77% |
Expected term of option | 6 years 2 months 1 day | 6 years 1 month 6 days |
Expected dividend yield | 0.00% | 0.00% |
STOCK-BASED COMPENSATION - Opti
STOCK-BASED COMPENSATION - Options Outstanding (Details) - USD ($) | Jun. 15, 2021 | Jun. 20, 2019 | Dec. 31, 2021 | Dec. 31, 2020 |
Chairman and Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding | ||||
Granted | 4,000,000 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | ||||
Granted | $ 2.85 | |||
Performance Based Option | Chairman and Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding | ||||
Granted | 4,000,000 | |||
Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding | ||||
Beginning Balance | 16,746,238 | 18,268,372 | ||
Exercised | (2,789,473) | |||
Granted | 17,939,552 | 2,380,686 | ||
Expired | (387,000) | (117,722) | ||
Forfeited | (1,055,000) | (995,625) | ||
Ending Balance | 33,243,790 | 16,746,238 | ||
Vested and expected to vest | 33,243,790 | |||
Exercisable | 15,294,016 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | ||||
Beginning balance | $ 2.71 | $ 2.58 | ||
Exercised | 1.39 | |||
Granted | 1.49 | 2.71 | ||
Expired | 4.56 | 5.06 | ||
Forfeited | 2.64 | 3.78 | ||
Ending Balance | 2.04 | $ 2.71 | ||
Vested and expected to vest | 2.04 | |||
Exercisable | $ 2.44 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures | ||||
Weighted Average Remaining Contractual Term In Years | 7 years 8 months 15 days | |||
Vested and expected to vest - Weighted Average Remaining Contractual Term In Years | 7 years 8 months 15 days | |||
Exercisable - Weighted Average Remaining Contractual Term In Years | 5 years 9 months 21 days | |||
Exercised - Aggregate Intrinsic Value | $ 1,856,978 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Outstanding (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Number Of Options Outstanding | shares | 33,243,790 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 8 months 15 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 2.04 |
Number Of Options Exercisable | shares | 15,294,016 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 2.44 |
$0.00 - $1.00 | |
Range of Exercise Prices Lower Range Limit | 0 |
Range of Exercise Prices Upper Range Limit | $ 1 |
Number Of Options Outstanding | shares | 3,223,853 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 7 months 28 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 0.87 |
Number Of Options Exercisable | shares | 1,373,853 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 0.87 |
$1.01 - $2.00 | |
Range of Exercise Prices Lower Range Limit | 1.01 |
Range of Exercise Prices Upper Range Limit | $ 2 |
Number Of Options Outstanding | shares | 20,495,481 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 11 months 23 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.52 |
Number Of Options Exercisable | shares | 6,158,707 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.47 |
$2.01 - $4.00 | |
Range of Exercise Prices Lower Range Limit | 2.01 |
Range of Exercise Prices Upper Range Limit | $ 4 |
Number Of Options Outstanding | shares | 8,209,456 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 3 months |
Number Of Options Outstanding Weighted Average Exercise Price | $ 2.99 |
Number Of Options Exercisable | shares | 6,746,456 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 2.94 |
$4.01 - $7.00 | |
Range of Exercise Prices Lower Range Limit | 4.01 |
Range of Exercise Prices Upper Range Limit | $ 7 |
Number Of Options Outstanding | shares | 1,110,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 6 years 7 months 24 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 6.82 |
Number Of Options Exercisable | shares | 810,000 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 6.89 |
$7.01 - $9.00 | |
Range of Exercise Prices Lower Range Limit | 7.01 |
Range of Exercise Prices Upper Range Limit | $ 9 |
Number Of Options Outstanding | shares | 205,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 6 years 6 months |
Number Of Options Outstanding Weighted Average Exercise Price | $ 8.23 |
Number Of Options Exercisable | shares | 205,000 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 8.23 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | Jun. 15, 2021 | Apr. 12, 2021 | Jun. 20, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Share-based Compensation | $ 7,770,000 | $ 7,821,000 | ||||
Performance Share Based Compensation Expense | $ 2,319,000 | $ 49,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1 | $ 1.85 | ||||
Share Based Payment Cash Received from Stock Option Exercises | $ 0 | $ 3,900,000 | ||||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | $ 16,148,000 | |||||
Unrecognized compensation cost is expected to be recognized over a weighted-average period (in years) | 2 years 8 months 12 days | |||||
Chairman and Chief Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Granted shares of common stock | 4,000,000 | |||||
Common stock exercise price | $ 2.85 | |||||
Time Based Stock Options | Chairman and Chief Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Granted shares of common stock | 4,000,000 | |||||
Performance Based Option | Chairman and Chief Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Granted shares of common stock | 4,000,000 | |||||
Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Expire Terms | 5 years | |||||
Long Term Incentive Plan 2011 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Common Stock Shares Carry Forward | 10,726,673 | |||||
2021 Incentive Plan, the maximum number of shares of Common Stock that are available for grants and award | 20,000,000 | 10,515,448 | ||||
Long Term Incentive Plan 2011 | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
2021 Incentive Plan, the maximum number of shares of Common Stock that are available for grants and award | 20,230,000 | |||||
Long Term Incentive Plan 2011 | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
2021 Incentive Plan, the maximum number of shares of Common Stock that are available for grants and award | 25,230,000 |
INCOME TAXES - Loss Before Inco
INCOME TAXES - Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
United States | $ (32,169) | $ (40,626) |
PRC | (3,673) | (6,885) |
Loss before income tax expense | $ (35,842) | $ (47,511) |
INCOME TAXES - Deferred Income
INCOME TAXES - Deferred Income Tax Assets And Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred income tax assets: | ||
Net operating loss carryforwards | $ 69,684 | $ 78,790 |
Research and development credit carryforwards | 4,259 | 6,244 |
Intangible assets | 8,051 | 8,049 |
Stock-based compensation | 5,336 | 5,126 |
Impairment loss of long-term investments | 182 | |
Other | 540 | 394 |
Valuation allowance for deferred income tax assets | (83,651) | (94,986) |
Net deferred income tax assets | 4,401 | 3,617 |
Deferred income tax liabilities: | ||
Deferred Royalty Income | (2,342) | (2,823) |
Change in fair value of investments | (1,865) | (690) |
Other | (194) | (104) |
Net deferred income tax liabilities | $ (4,401) | $ (3,617) |
INCOME TAXES - Reconciliation O
INCOME TAXES - Reconciliation Of The Provision For Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
Federal statutory rate (as a percent) | 21.00% | 21.00% |
Tax benefit at statutory rate of 21% | $ (7,526) | $ (9,977) |
State taxes | (732) | |
Attribute expiration | 10,676 | 13,707 |
Change in applicable tax rates | 7,117 | 11,612 |
Nondeductible expenses | 1,059 | 358 |
Deemed royalty | 4,220 | |
Others | 9 | (54) |
Change in valuation allowance | (11,335) | (19,134) |
Total | $ 0 | $ 0 |
INCOME TAXES - Gross Unrecogniz
INCOME TAXES - Gross Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
Beginning balance | $ 2,082 | $ 2,581 |
Reductions for tax positions of prior periods | (642) | (499) |
Additions for tax positions of current period | 0 | 0 |
Ending balance | $ 1,440 | $ 2,082 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Contingency | |||
Net reduction of unrecognized tax benefits | $ 642 | $ 499 | |
Operating loss carryforwards, tax | $ 4,300 | ||
Expiration period for unused tax carryforwards | 20 years | ||
Unrecognized tax benefits | $ 1,440 | $ 2,082 | $ 2,581 |
Domestic Tax Authority | |||
Income Tax Contingency | |||
Operating loss carryforwards | 302,100 | ||
Foreign Tax Authority | |||
Income Tax Contingency | |||
Operating loss carryforwards | $ 24,200 |
FAIR VALUE MEASUREMENTS - Finan
FAIR VALUE MEASUREMENTS - Financial and Non-Financial Assets and Liabilities (Details) | 12 Months Ended | ||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Jun. 30, 2020USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Long-lived assets | $ 1,550,000 | ||
Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in common stock | $ 9,868,000 | $ 9,309,000 | |
Investment in warrants -Designated as investment measured at FVTPL | 591,000 | 840,000 | |
Investment in convertible loan-AFS | 268,000 | 83,000 | |
Investment in convertible loan-Designated as investment measured at FVTPL | 5,576,000 | ||
Level 1 | Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in common stock | 9,868,000 | 9,309,000 | |
Investment in warrants -Designated as investment measured at FVTPL | 0 | 0 | |
Investment in convertible loan-AFS | 0 | 0 | |
Investment in convertible loan-Designated as investment measured at FVTPL | 0 | ||
Level 2 | Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in common stock | 0 | 0 | |
Investment in warrants -Designated as investment measured at FVTPL | 591,000 | 840,000 | |
Investment in convertible loan-AFS | 0 | 0 | |
Investment in convertible loan-Designated as investment measured at FVTPL | 0 | ||
Level 3 | Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in common stock | 0 | 0 | |
Investment in warrants -Designated as investment measured at FVTPL | 0 | 0 | |
Investment in convertible loan-AFS | 268,000 | $ 83,000 | |
Investment in convertible loan-Designated as investment measured at FVTPL | $ 5,576,000 | ||
Level 3 | Recurring | Discount rate | Average | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in convertible loan using measurement alternative, measurement input | 20 | ||
Level 3 | Recurring | Discount rate | Median | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in convertible loan using measurement alternative, measurement input | 20 |
FAIR VALUE MEASUREMENTS - Quant
FAIR VALUE MEASUREMENTS - Quantitative Information about Level 3 Fair Value Measurements (Details) - Non-recurring - Level 3 - Market approach $ in Thousands | Oct. 23, 2021USD ($) | Sep. 29, 2020USD ($) |
Average | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Investment in equity securities using measurement alternative, measurement input | 5.3 | |
Equity securities at fair value | $ 32,308 | $ 26,059 |
Median | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Investment in equity securities using measurement alternative, measurement input | 1.1 | |
Expected volatility | Average | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Investment in equity securities using measurement alternative, measurement input | 59 | |
Expected volatility | Median | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Investment in equity securities using measurement alternative, measurement input | 58 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||
Carrying amount | $ 3,087,000 | |||
Intangible assets and assets held for sale | 1,550,000 | |||
Impairment of equipment | $ 0 | $ 0 | ||
Impairment of intangible assets | $ 1,537,000 | 0 | 1,500,000 | |
Machinery and Equipment | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||
Impairment of equipment | 0 | |||
Level 2 | Black Belt Tx Limited | Convertible loan | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||
Available-for-sale debt securities | $ 1,385,000 | |||
Recurring | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||
Non-financial assets, measured at fair value | 0 | 0 | ||
Non-financial liabilities, measured at fair value | 0 | $ 0 | ||
Non-recurring | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||
Non-financial assets, measured at fair value | $ 0 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | Mar. 24, 2021USD ($)$ / sharesshares | Jul. 24, 2020shares | Jul. 01, 2019USD ($) | Jul. 01, 2019CNY (¥) | Jan. 31, 2020USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Related Party Transaction | |||||||||
Lease income | $ 148,000 | $ 140,000 | |||||||
Shares issued | shares | 15,853,658 | 23,000,000 | 493,000 | ||||||
Offering price per share | $ / shares | $ 2.05 | ||||||||
Net proceeds from issuance of common stock | $ 32,500,000 | $ 1,539,000 | |||||||
BioCheck Inc. | |||||||||
Related Party Transaction | |||||||||
Term of lease contract | 1 year | ||||||||
Lease payments | $ 12,000 | $ 5,000 | 60,000 | 144,000 | $ 60,000 | ||||
Juventas Cell Therapy Ltd. | |||||||||
Related Party Transaction | |||||||||
Term of lease contract | 1 year | 1 year | |||||||
Lease payments | $ 15,000 | ¥ 80,000 | |||||||
Lease income | $ 148,000 | $ 140,000 | |||||||
Chairman and Chief Executive Officer | Emerging Technology Partners LLC | |||||||||
Related Party Transaction | |||||||||
Shares issued | shares | 3,000,000 | ||||||||
Offering price per share | $ / shares | $ 2.05 | ||||||||
Net proceeds from issuance of common stock | $ 6,150,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) ¥ in Millions | 1 Months Ended | 12 Months Ended | ||||||||
Aug. 31, 2021USD ($) | Aug. 31, 2021EUR (€) | Jun. 30, 2021USD ($) | Nov. 30, 2019USD ($) | Nov. 30, 2019CNY (¥) | Dec. 31, 2021USD ($)Milestone | Dec. 31, 2020USD ($) | Aug. 31, 2021EUR (€) | Dec. 31, 2020CNY (¥) | Nov. 30, 2019CNY (¥) | |
Payment for property improvements | $ | $ 8,945,000 | $ 1,499,000 | ||||||||
CASI Wuxi | ||||||||||
Contractual obligation | 12,000,000 | ¥ 76.1 | ||||||||
Fixed assets investment, commitment amount | 2,300,000 | 14.6 | ||||||||
Land use right and property, plant and equipment, commitment amount | $ 143,000,000 | ¥ 1,000 | ||||||||
Estimated construction period | 3 years | 3 years | ||||||||
Construction project contract amount | $ 8,500,000 | ¥ 54.5 | ||||||||
CASI Wuxi | Building | ||||||||||
Contractual obligation | $ 14,600,000 | ¥ 92.9 | ||||||||
Cleave Therapeutics, Inc | ||||||||||
Number of milestones achieved | 0 | |||||||||
BioInvent International AB | ||||||||||
Number of milestones achieved | 0 | |||||||||
Black Belt Therapeutics Ltd | ||||||||||
Number of milestones achieved | 0 | |||||||||
Milestone payment | $ 305,000 | € 250,000 | $ 750,000 | |||||||
Accrued milestone payment | $ 305,000 | € 250,000 | ||||||||
Pharmathen Global BV | ||||||||||
Number of milestone payments yet to be paid | $ | 1 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - China Resources Guokang Pharmaceuticals Co., Ltd | 1 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2019 | |
Subsequent Events | ||
Non royalty exclusive distribution period | 3 years | |
Subsequent Events. | ||
Subsequent Events | ||
Renewal period | 2 years |