Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 08, 2021 | |
Cover | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 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 | |
Trading Symbol | CASI | |
Security Exchange Name | NASDAQ | |
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 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0000895051 | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 139,797,487 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 53,126 | $ 57,064 |
Investment in equity securities, at fair value | 9,503 | 9,309 |
Accounts receivable, net of $0 allowance for doubtful accounts | 5,418 | 4,645 |
Inventories | 1,727 | 1,356 |
Prepaid expenses and other | 2,190 | 1,651 |
Total current assets | 71,964 | 74,025 |
Property, plant and equipment, net | 6,778 | 2,062 |
Intangible assets, net | 12,358 | 13,210 |
Long-term investments | 34,177 | 29,442 |
Right of use assets | 9,499 | 8,696 |
Other assets | 1,498 | 299 |
Total assets | 136,274 | 127,734 |
Current liabilities: | ||
Accounts payable | 6,324 | 3,669 |
Accrued and other current liabilities | 2,550 | 3,015 |
Bank borrowings | 1,084 | 826 |
Notes payable | 466 | |
Total current liabilities | 9,958 | 7,976 |
Deferred income | 2,342 | 2,351 |
Other liabilities | 14,460 | 13,834 |
Total liabilities | 26,760 | 24,161 |
Commitments and contingencies (Note 19) | ||
Redeemable noncontrolling interest, at redemption value (Note 11) | 22,907 | 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 September 30, 2021 and December 31, 2020 139,877,032 shares and 124,023,374 shares issued at September 30, 2021 and December 31, 2020, respectively; | 1,399 | 1,240 |
Additional paid-in capital | 692,041 | 658,246 |
Treasury stock, at cost: 79,545 shares held at September 30, 2021 and December 31, 2020 | (8,034) | (8,034) |
Accumulated other comprehensive income | 1,169 | 589 |
Accumulated deficit | (599,968) | (570,501) |
Total stockholders' equity | 86,607 | 81,540 |
Total liabilities, redeemable noncontrolling interest and stockholders' equity | $ 136,274 | $ 127,734 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 1 | $ 1 |
Preferred Stock, Shares Authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued (in shares) | 0 | 0 |
Preferred Stock, Shares Outstanding (is shares) | 0 | 0 |
Common Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 |
Common Stock, Shares Issued (in shares) | 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Product sales | $ 8,075 | $ 4,205 | $ 20,900 | $ 10,215 |
Lease income | 37 | 37 | 110 | 104 |
Total revenues | 8,112 | 4,242 | 21,010 | 10,319 |
Costs of revenues: | ||||
Cost of goods sold | 1,831 | 1,012 | 4,625 | 5,549 |
Royalty fee | 1,586 | 816 | 4,132 | 2,007 |
Total costs of revenues | 3,417 | 1,828 | 8,757 | 7,556 |
Operating expenses: | ||||
Research and development | 2,895 | 2,803 | 10,408 | 7,682 |
General and administrative | 5,259 | 5,347 | 16,184 | 13,490 |
Selling and marketing | 3,433 | 2,062 | 9,508 | 4,879 |
Loss on disposal of property, plant, equipment | 65 | |||
Gain on disposal of intangible assets | 0 | 0 | 0 | (450) |
Impairment of intangible assets | 1,537 | |||
Acquired in-process research and development | 0 | 10,862 | 6,555 | 11,943 |
Total operating expenses | 11,587 | 21,074 | 42,720 | 39,081 |
Loss from operations | (6,892) | (18,660) | (30,467) | (36,318) |
Non-operating income/(expense): | ||||
Interest income, net | 79 | 432 | 261 | 775 |
Other income | 487 | 20 | 540 | 47 |
Foreign exchange gains (losses) | (6) | (526) | 289 | (278) |
Change in fair value of investments | (3,687) | 1,978 | (205) | 2,287 |
Impairment loss of long-term investments | (865) | |||
Net loss | (10,019) | (16,756) | (30,447) | (33,487) |
Less: loss attributable to redeemable noncontrolling interest | (314) | (309) | (980) | (584) |
Accretion to redeemable noncontrolling interest redemption value | 519 | 506 | 1,586 | 1,185 |
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (10,224) | $ (16,953) | $ (31,053) | $ (34,088) |
Net loss per share (basic and diluted) | $ (0.07) | $ (0.14) | $ (0.23) | $ (0.32) |
Weighted average number of common shares outstanding (basic and diluted) | 139,797,487 | 117,940,405 | 134,861,366 | 105,922,281 |
Weighted average number of common shares (basic) | 139,797,487 | 117,940,405 | 134,861,366 | 105,922,281 |
Comprehensive loss: | ||||
Net loss | $ (10,019) | $ (16,756) | $ (30,447) | $ (33,487) |
Foreign currency translation adjustment | 15 | 2,383 | 848 | 1,221 |
Total comprehensive loss | (10,004) | (14,373) | (29,599) | (32,266) |
Less: Comprehensive loss attributable to redeemable noncontrolling interest | (309) | (309) | (712) | (584) |
Comprehensive loss attributable to common stockholders | $ (9,695) | $ (14,064) | $ (28,887) | $ (31,682) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Preferred Stock | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 0 | $ 979,000 | $ 606,686,000 | $ (8,034,000) | $ (2,728,000) | $ (523,908,000) | $ 72,995,000 |
Balance (in shares) at Dec. 31, 2019 | 0 | 97,771,698 | |||||
Issuance of common stock for options and warrants exercised | $ 27,000 | 3,847,000 | 3,874,000 | ||||
Issuance of common stock for options and warrants exercised (in shares) | 2,737,795 | ||||||
Repurchase of stock options to satisfy tax withholding obligations | $ 0 | $ 0 | (251,000) | 0 | 0 | 0 | (251,000) |
Issuance of common stock pursuant to financing agreements | $ 234,000 | 44,865,000 | 45,099,000 | ||||
Issuance of common stock pursuant to financing agreements (in shares) | 23,434,336 | ||||||
Stock issuance costs | 0 | $ 0 | (3,008,000) | 0 | 0 | 0 | (3,008,000) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 5,685,000 | 0 | 0 | 0 | 5,685,000 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 1,221,000 | 0 | 1,221,000 |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (1,185,000) | 0 | 0 | (32,903,000) | (34,088,000) |
Balance at Sep. 30, 2020 | $ 0 | $ 1,240,000 | 656,639,000 | (8,034,000) | (1,507,000) | (556,811,000) | 91,527,000 |
Balance (in shares) at Sep. 30, 2020 | 0 | 123,943,829 | |||||
Balance at Jun. 30, 2020 | $ 1,010,000 | 614,617,000 | (8,034,000) | (3,890,000) | (540,364,000) | 63,339,000 | |
Balance (in shares) at Jun. 30, 2020 | 100,928,829 | ||||||
Issuance of common stock for options and warrants exercised | 22,000 | 22,000 | |||||
Issuance of common stock for options and warrants exercised (in shares) | 15,000 | ||||||
Issuance of common stock pursuant to financing agreements | $ 230,000 | 43,470,000 | 43,700,000 | ||||
Issuance of common stock pursuant to financing agreements (in shares) | 23,000,000 | ||||||
Stock issuance costs | (2,757,000) | (2,757,000) | |||||
Stock-based compensation expense, net of forfeitures | 1,793,000 | 1,793,000 | |||||
Foreign currency translation adjustment | 2,383,000 | 2,383,000 | |||||
Net loss attributable to CASI Pharmaceuticals, Inc. | (506,000) | (16,447,000) | (16,953,000) | ||||
Balance at Sep. 30, 2020 | $ 0 | $ 1,240,000 | 656,639,000 | (8,034,000) | (1,507,000) | (556,811,000) | 91,527,000 |
Balance (in shares) at Sep. 30, 2020 | 0 | 123,943,829 | |||||
Balance at Dec. 31, 2020 | $ 0 | $ 1,240,000 | 658,246,000 | (8,034,000) | 589,000 | (570,501,000) | 81,540,000 |
Balance (in shares) at Dec. 31, 2020 | 0 | 123,943,829 | |||||
Issuance of common stock pursuant to financing agreements | $ 159,000 | 32,341,000 | 0 | 0 | 0 | 32,500,000 | |
Issuance of common stock pursuant to financing agreements (in shares) | 15,853,658 | ||||||
Stock issuance costs | (2,019,000) | 0 | 0 | 0 | (2,019,000) | ||
Stock-based compensation expense, net of forfeitures | $ 0 | $ 0 | 5,059,000 | 0 | 0 | 0 | 5,059,000 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 580,000 | 0 | 580,000 |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (1,586,000) | 0 | 0 | (29,467,000) | (31,053,000) |
Balance at Sep. 30, 2021 | $ 0 | $ 1,399,000 | 692,041,000 | (8,034,000) | 1,169,000 | (599,968,000) | 86,607,000 |
Balance (in shares) at Sep. 30, 2021 | 0 | 139,797,487 | |||||
Balance at Jun. 30, 2021 | $ 1,399,000 | 690,539,000 | (8,034,000) | 1,159,000 | (590,263,000) | 94,800,000 | |
Balance (in shares) at Jun. 30, 2021 | 139,797,487 | ||||||
Stock-based compensation expense, net of forfeitures | 2,021,000 | 2,021,000 | |||||
Foreign currency translation adjustment | 10,000 | 10,000 | |||||
Net loss attributable to CASI Pharmaceuticals, Inc. | (519,000) | (9,705,000) | (10,224,000) | ||||
Balance at Sep. 30, 2021 | $ 0 | $ 1,399,000 | $ 692,041,000 | $ (8,034,000) | $ 1,169,000 | $ (599,968,000) | $ 86,607,000 |
Balance (in shares) at Sep. 30, 2021 | 0 | 139,797,487 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (30,447) | $ (33,487) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation for property, plant and equipment | 393 | 389 |
Loss on disposal of property, plant and equipment | 65 | |
Amortization of intangible assets | 1,009 | 1,095 |
Reduction in the carrying amount of the right-of-use assets | 1,031 | 973 |
Gain on disposal of intangible assets | 0 | (450) |
Impairment of intangible assets | 1,537 | |
Stock-based compensation expense | 5,059 | 5,685 |
Acquired in-process research and development | 6,555 | 11,943 |
Government grant as a result of loan forgiveness | (472) | |
Change in fair value of investments | 205 | (2,287) |
Impairment loss of long-term investments | 865 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (773) | (2,785) |
Inventories | (371) | 3,822 |
Prepaid expenses and other assets | (539) | (434) |
Accounts payable | 26 | (2,434) |
Accrued liabilities and other liabilities | (1,770) | (1,398) |
Deferred income | (37) | (23) |
Net cash used in operating activities | (19,201) | (17,854) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from disposal of intangible assets | 1,700 | |
Proceeds from disposal of property and equipment | 10 | |
Purchases of property, plant and equipment | (3,730) | (367) |
Loan to a related party | (10,033) | |
Receipt of repayment of loan from a related party | 10,033 | |
Cash paid to acquire in-process research and development | (6,555) | (11,678) |
Receipt of government grants related to land use right | 2,278 | |
Net cash used in investing activities | (15,950) | (8,150) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from notes payable | 466 | |
Proceeds from bank borrowings | 709 | |
Repayment of bank borrowings | (463) | |
Stock issuance costs | (2,019) | (2,800) |
Proceeds from sale of common stock | 32,500 | 45,099 |
Proceeds from exercise of stock options | 3,874 | |
Repurchase of stock options to satisfy tax withholding obligations | (251) | |
Net cash provided by financing activities | 30,727 | 46,388 |
Effect of exchange rate change on cash and cash equivalents | 486 | 587 |
Net increase in cash and cash equivalents | (3,938) | 20,971 |
Cash and cash equivalents at beginning of period | 57,064 | 53,621 |
Cash and cash equivalents at end of period | 53,126 | 74,592 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 0 | 0 |
Income taxes paid | 0 | 0 |
Non-cash investing activity: | ||
Capital Expenditures Incurred but Not yet Paid | 2,680 | |
Black Belt Tx Limited | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Cash paid to acquire convertible loan | (86) | $ (83) |
Receipt of repayment of Black Belt Convertible note | 172 | |
Alesta Tx | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Cash paid to acquire convertible loan | (261) | |
Cleave Therapeutics, Inc | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Cash paid to acquire convertible loan | $ (5,500) |
Basis of Presentation, Organiza
Basis of Presentation, Organization and Principal Activities | 9 Months Ended |
Sep. 30, 2021 | |
Basis of Presentation, Organization and Principal Activities | |
Basis of Presentation, Organization and Principal Activities | 1. Basis of Presentation, Organization and Principal Activities Basis of Presentation 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 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 accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, in which CASI, directly or indirectly, has a controlling financial interest. These subsidiaries include Miikana Therapeutics, Inc. (“Miikana”), CASI Pharmaceuticals (China) Co., Ltd. (“CASI China”), CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”), CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”), and CASI Pharmaceuticals (Hainan) Co., Ltd. (“CASI Hainan”). CASI China is a non-stock Chinese entity with 100% of its interest owned by CASI. CASI China received approval for a business license from the Beijing Industry and Commercial Administration in August 2012 and has operating facilities in Beijing. CASI Hainan is a wholly owned subsidiary of CASI China and was established in June 2021. CASI Biopharmaceuticals is a wholly owned subsidiary of CASI Wuxi and was established in April 2019. The Company controls CASI Wuxi through 80% voting rights (see Note 11). Accordingly, the financial statements of CASI Wuxi have been consolidated in the Company’s consolidated financial statements since its inception. All inter-company balances and transactions have been eliminated in consolidation. The Company currently operates in one operating segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such condensed consolidated financial statements do not include all of the information and disclosures required by U.S. generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. The accompanying December 31, 2020 financial information was derived from the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated balance sheet of the Company as of December 31, 2020 and the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the year ended December 31, 2020. Liquidity Risks and Management’s Plans 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, distribution and manufacturing. The majority of the Company’s operations are now located in China. The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities and expansion of the Company’s operations. The Company’s Beijing office is primarily responsible for the Company’s day-to-day operations and the Company’s commercial team of over 100 hematology/oncology sales and marketing specialists based in China. CASI Wuxi is part of the long-term strategy to support the Company’s future clinical and commercial distribution and manufacturing needs, to manage the Company’s supply chain for certain products, and to develop a GMP manufacturing facility in China. The Company has primarily funded its operations through the proceeds from the sales of common stock. To date, the Company has product revenue and management expects operating losses to continue for the foreseeable future. On October 29, 2021, the Company has entered into a common stock sales agreement (“stock sales agreement ”), with H.C. Wainwright & Co., LLC (“Wainwright”), relating to shares of common stock of the Company, $0.01 par value per share. In accordance with the terms of the sales agreement, the Company may offer and sell shares of common stock having an aggregate offering price of not more than $20,000,000. Taking into consideration the cash and cash equivalents balance as of September 30, 2021, the Company believes that it has sufficient resources to fund its operations at least one year beyond the date that the unaudited condensed consolidated financial statements are issued. As of September 30, 2021, the Company had a consolidated cash balance of $53.1 million. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements. Risks and Uncertainties The Company has experienced operational interruptions as a result of COVID-19, including the temporary disruption of operations in China during 2020 due to a Chinese government mandated quarantine protocol, including mandatory business closures, social distancing measures, and various travel restrictions. In the first quarter 2020, during which the peak of the pandemic occurred in China, the Company experienced some disruptions to its EVOMELA ® To the extent that such events occur, demand for the Company's products may decline, and the Chinese government or other governments may impose additional restrictions resulting in further shutdowns, further work restrictions, and the disruption of the Company’s supply and distribution channels; there can be no assurance that such restrictions will not be imposed again. The Company currently relies on a single source for its supply of EVOMELA ® ® 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 ® Clinical trials, whether planned or ongoing, may be affected by the COVID-19 pandemic. The COVID-19 pandemic has also impacted the Company's targeted start time of its CID-103 trial due to the lock-down of many medical facilities in Europe. Study procedures (particularly any procedures that may be deemed non-essential), site initiation, participant recruitment and enrollment, participant dosing, shipment of the Company's product candidates, distribution of clinical trial materials, study monitoring, site inspections and data analysis may be paused or delayed due to changes in hospital or research institution policies, federal, state or local regulations, prioritization of hospital and other medical resources toward COVID-19 efforts, or other reasons related to the pandemic. In addition, there could be a potential effect of COVID-19 on the operations of the health regulatory authorities, which could result in delays of reviews and approvals, including with respect to the Company's product candidates. Any prolongation or de-prioritization of the Company's clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and approval of the Company's product candidates. |
License and Distribution Agreem
License and Distribution Agreements | 9 Months Ended |
Sep. 30, 2021 | |
License and Distribution Agreements | |
License and Distribution Agreements | 2. License and Distribution Agreements Acrotech License Arrangements Spectrum Pharmaceuticals, which they later transferred to Acrotech. On December 3, 2018, the Company received NMPA’s approval for importation, marketing and sales in China and in August 2019 the Company launched EVOMELA® in China. The NMPA required post-marketing study is ongoing. The Company is currently evaluating future development options for ZEVALIN® and MARQIBO® due to the evolving standard of care environment, the rare and niche indications for these products, potential US regulatory action and its commitment to prioritize resources. China Resources Guokang Pharmaceuticals Co., Ltd In March 2019, the Company entered into a three-year exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd (“CRGK”) to appoint CRGK on an exclusive basis as its distributor to distribute EVOMELA ® in the territory of the People’s Republic of China (excluding Hong Kong, Taiwan and Macau), subject to certain terms and conditions. The Company’s internal marketing and sales team are responsible for commercial activities, including, for example, direct interaction with Key Opinion Leaders (KOL), physicians, hospital centers and the generating of sales. Commercial sales of EVOMELA ® were launched in August 2019. For the three months ended September 30, 2021 and 2020, the Company recognized $8.1 million and $4.2 million of revenues from sales of EVOMELA® under this arrangement. For the nine months ended September 30, 2021 and 2020, the Company recognized $20.9 million and $10.2 million of revenues from sales of EVOMELA ® under this arrangement. Juventas Cell Therapy In June 2019, the Company entered into a license agreement for exclusive worldwide license to commercialize an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. (“Juventas”) (the “Juventas license agreement”). Juventas is a China-based company engaged in cell therapy. In September 2020, Juventas and its shareholders (including CASI Biopharmaceuticals) agreed to certain terms and conditions required by a new third-party investor to facilitate the Series B financing of Juventas, pursuant to which the Company agreed to amend and supplement the original licensing agreement (the "Supplementary Agreement") by agreeing to pay Juventas certain percentage of profits generated from commercial sales of CNCT19. The Supplementary Agreement also specifies a minimum annual target net profit to be distributed to Juventas and certain other terms and obligations. In return, the Company obtained additional equity interests in Juventas (see Note 4). 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 BioInvent’s lead drug candidate and is being investigated in a Phase 1/2 trial, in combination with anti-PD1 therapy Keytruda ® ® 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 uses, the Company expensed $5.9 million as acquired in-process research and development in the fourth quarter of 2020. Black Belt Therapeutics Limited In April 2019, the Company entered into a license agreement with Black Belt Therapeutics Limited (“Black Belt”) for exclusive worldwide rights to CID-103, an investigational anti-CD38 monoclonal antibody (Mab) (formerly known as TSK011010). The 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) as well as 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 ($298,000) 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 $1.06 million as acquired in-process research and development in the unaudited consolidated statements of operations and comprehensive loss for the nine months ended September 30, 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. 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 uses, the Company expensed $5.5 million as acquired in-process research and development in the accompanying consolidated statements of operations and comprehensive loss for the nine months ended September 30, 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. Subject to regulatory and marketing approvals, the Company intends to advance and commercialize this established 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 expensed in the year ended December 31, 2020 as acquired in-process research and development following Pharmathen’s achievement of certain milestones. CASI is responsible for the development, import drug registration, product approval and commercialization in China. CASI has a 10-year non-royalty exclusive distribution period after the product launch at agreed supply costs for the first three years . 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Revenue Recognition Product sales recognized in the consolidated statements of operations 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. As of September 30, 2021, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of September 30, 2021. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to recoverability of operating lease right-of-use assets, intangible assets and long-term investments, net realizable value and obsolescence allowance for inventory, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments. 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. |
Investment in equity securities
Investment in equity securities, at fair value and long-term investments | 9 Months Ended |
Sep. 30, 2021 | |
Investment in equity securities, at fair value and long-term investments | |
Investment in equity securities, at fair value and long-term investments | 4. Investment in equity securities, at fair value and long-term investments Investment in equity securities, at fair value 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 statement of operations each reporting period. BioInvent International AB In October 2020, in conjunction with its license agreement entered into with BioInvent (see Note 2), 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 $4.9 million as of September 30, 2021 and $6.6 million as of December 31, 2020 (see Note 17). The fair value of the warrants was measured using observable market-based inputs other than quoted prices in active markets for identical assets or liabilities, 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 $352,000 as of September 30, 2021 (see Note 17), with assumptions including an expected life of 4.16 years, an assumed volatility of 44.95 %, and a risk-free interest rate of 0.0456 %. The following table summarizes the Company’s investment in equity securities at Fair Value as of September 30, 2021: Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains (losses) value MaxCyte - equity interest Investment $ — $ 4,591 $ 4,591 BioInvent - equity interest Investment $ 5,661 $ (749) $ 4,912 Total $ 9,503 Unrealized gains or (losses) on the Company’s equity investment for the three months ended September 30, 2021 and 2020 were $(3,729,000) and $862,000. Unrealized gains or (losses) on the Company’s equity investment for the nine months ended September 30, 2021 and 2020 were $(294,000) and $1,171,000. Unrealized gains or (losses) on the Company’s equity investment are recognized as change in fair value of investment in equity securities in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. Long-term investments Long-term investments consisted of the following: September 30, December 31, (In thousands) 2021 2020 Available-for-sale debt securities: Black Belt Tx Limited - convertible loan $ 264 $ 83 Securities measured at fair value: BioInvent International AB - warrants 352 840 Cleave Therapeutics, Inc. - convertible loan 5,589 — Equity securities without readily determinable fair value: Black Belt Tx Limited - equity interest 1,385 2,250 Juventas Cell Therapy Ltd - equity interest 26,375 26,059 Juventas Cell Therapy Ltd - put option 212 210 Total $ 34,177 $ 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 2), the Company made a 2 million euros ($2,249,600) equity investment in the ordinary shares of a newly established, privately held UK Company, Black Belt Tx 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 nine months ended September 30, 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 ( $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 euros to the Company, including 1st tranche of 70,600 euros, 2nd tranche of 70,600 euros and interest of 5,366 euros. 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 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 2), the Company, through CASI Biopharmaceuticals, made an RMB 80 million ($11,788,000) investment in Juventas, a privately held, China-based company, in Juventas’ Series A plus equity, which represented a 16.327% equity interest on a fully diluted basis, and the right to appoint a non-voting board observer. The Company is entitled to substantive liquidation preference over the founding shareholders of Juventas. In addition, the Juventas’ founding shareholder provided a put option to the Company pursuant to which the Company can put the equity investment to the founding shareholder at a fixed return of 8% per annum upon occurrence of certain events. The investment in the equity interests of the Juventas and the investment in put option to the founding shareholder were accounted for as investments in equity securities using the measurement alternative at its cost, minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer, as the fair value of the equity securities of Juventas is not readily determinable. The consideration of RMB 80 million ($11,788,000) was allocated into investment in equity interests and investment in put option based on their relative fair value on the transaction date. In September 2020, in conjunction with the Supplementary Agreement entered into with Juventas (see Note 2), the Company obtained additional Series A plus equity interest in Juventas with substantive liquidation preference over Juventas' founding shareholder, 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 shareholder also provided a put option to the Company pursuant to which the Company can put the additional equity investment to the founding shareholder at RMB 70 million plus a fixed return of 8% per annum upon occurrence of certain events. The transaction closed on September 29, 2020. The fair value of the Company’s additional equity interest in Juventas and the new put option was estimated using significant estimates and assumptions, including multiples of selected comparable companies in applying the market approach model. Since the equity interest with substantive liquidation preference is not in-substance common stock, the investment in the additional equity interests of Juventas was accounted for as an investment in equity securities at transaction date fair value with a corresponding credit to Other Liabilities. The profit-sharing liability represents the Company’s obligation to pay an increased share of future profits pursuant to the Supplementary Agreement (see Note 2) which was conveyed by the Company in exchange for the additional equity interests in Juventas. The Company views this as a payment from a vendor that should reduce cost of revenues over the period of royalty payments. The long-term liability will be derecognized as payments are made on a systematic and rational basis representing the pattern in which the Company expects to settle the profit-sharing payment during the commercialization period of CNCT19. The investments are measured using the measurement alternative at its cost, minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer, as the fair value of the equity securities of Juventas is not readily determinable. The Company did not record any adjustments or impairments during the three and nine months ended September 30, 2021 related to this 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 On October 26, 2021, Juventas Cell Therapy Ltd. (“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. Cleave Therapeutics, Inc. In March 2021, Cleave and the Company entered into a license agreement. 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. Cleave received a $5.5 million upfront payment and is eligible to receive 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. In addition to the upfront cash payment, CASI made a $5.5 million investment in Cleave through a three-year convertible note with a non-compounding 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. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2021 | |
Inventories | |
Inventories | 5. Inventories Inventories at September 30, 2021 and December 31, 2020 consisted of the following: (In thousands) September 30, 2021 December 31, 2020 Finished goods $ 1,727 $ 1,356 Raw materials — — Total $ 1,727 $ 1,356 No write down to the carrying amount of inventory have been recorded in the three and nine months ended September 30, 2021 and 2020. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Leases | 6. Leases Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. Operating lease liabilities (see below) are included in accrued and other current liabilities and other liabilities (noncurrent) in the unaudited condensed consolidated balance sheets as of September 30, 2021 and December 31, 2020. All of the Company’s existing leases as of September 30, 2021 are classified as operating leases. As of September 30, 2021, the Company had eight material operating leases for land and facilities with remaining terms expiring from 2021 through 2069 and a weighted average remaining lease term of 34.89 years. 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 is 3.58%. The discount rates reflect the estimated incremental borrowing rate, which includes an assessment of the credit rating to determine the rate that the Company would have to pay to borrow, on a collateralized basis for a similar term, an amount equal to the lease payments in a similar economic environment. In November 2019, CASI Wuxi entered into a fifty-year lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility. The land parcel is 74,028.40 square meters. The Company classifies this lease as an operating lease. The Company prepaid all of the lease payments for the land use right in 2019 in the amount of RMB 45 million (equivalent to $6.5 million). Rent expense for the nine months ended September 30, 2021 and 2020 was $1,158,000 and $1,153,000, respectively. There were no variable lease costs or sublease income for leased assets for the nine months ended September 30, 2021 and 2020. Right of use assets and liabilities as of September 30, 2021 and December 31, 2020 in the condensed consolidated balance sheets were as follows: September 30, December 31, (In thousands) 2021 2020 Right of use assets $ 9,499 $ 8,696 Accrued and other current liabilities $ 1,213 $ 939 Other liabilities 1,434 965 Total lease liabilities $ 2,647 $ 1,904 Supplemental cash flow information related to leases was as follows: Nine Months Ended September 30, (In thousands) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,087 $ 1,064 Right of use assets obtained in exchange for lease obligations: $ 1,661 $ 1,030 A maturity analysis of the Company’s operating leases as of September 30, 2021 follows: Future undiscounted cash flows: (In thousands) 2021 (remaining three months) $ 355 2022 1,157 2023 803 Thereafter 373 Total 2,688 Discount factor (41) Lease liability 2,647 Amounts due within 12 months 1,213 Non-current lease liability $ 1,434 |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 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 unaudited condensed consolidated statement of operations and comprehensive loss for the three months ended March 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 three months ended March 31, 2020. The Company will recognize the variable consideration and additional gain on disposal of intangible assets when the constraint on variable consideration is resolved, i.e., Chartwell receives relevant FDA approvals. As of September 30, 2021, no FDA approvals has been obtained by Chartwell on those products. Intangible assets at September 30, 2021 consists of the following: (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,832 (3,540) 13 years Others 197 (131) 5 years Total $ 16,029 $ (3,671) The changes in intangible assets for nine months ended September 30, 2021 are as follows: (In thousands) Balance as of December 31, 2020 $ 13,210 Amortization expense (1,009) Foreign currency translation adjustment 157 Balance as of September 30, 2021 $ 12,358 Expected future amortization expense, is as follows: (In thousands) 2021 (remaining three months) $ 334 2022 1,334 2023 1,334 2024 1,303 2025 1,303 2026 and thereafter 6,750 |
Grants
Grants | 9 Months Ended |
Sep. 30, 2021 | |
Grants | |
Grants | 8. Grants 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. The grant will be amortized over the term of the lease of the land. Since April 2020, the Company has recognized RMB 481,000 in deferred income as of September 30, 2021, and therefore, RMB 15.4 million (equivalent to $2.4 million) remain as deferred income in the unaudited condensed balance sheet as of September 30, 2021. The Company recognized $12,000 and $12,000 of other income during the three months ended September 30, 2021 and 2020, respectively. The Company recognized $37,000 and $23,000 of other income during the nine months ended September 30, 2021 and 2020, respectively. |
Bank Borrowings
Bank Borrowings | 9 Months Ended |
Sep. 30, 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 ($826,000), which matures on November 7, 2021, and bears interest at a fixed rate of 3.35% per annum. On February 3, 2021, the Company had additional bank borrowings of RMB 4.6 million ($0.7 million), of which RMB 3.0 million ($0.5 million) repaid on September 2, 2021 and the remainder balance matures on November 7, 2021. These additional bank borrowings bear interest at a fixed rate of 3.72% per annum. Interest expense of $12,000 and $37,000 was recorded in the three and nine months ended September 30, 2021. |
Notes Payable
Notes Payable | 9 Months Ended |
Sep. 30, 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 percent per annum. Some or all of the loan may be forgiven if the Company complies with certain relevant conditions. In June 2020, the PPP was amended through enactment of the Paycheck Protection Program Flexibility Act of 2020 (PPPFA). Under the new act, the Company’s payments of principal and interest are deferred until October 2021. In September 2021, the loan principal of $465,595 and outstanding interest of $6,212 were forgiven. Interest expenses of $900 and $1,200 were recorded in the three months ended September 30, 2021 and 2020. Interest expenses of $2,900 and $1,900 were recorded in the nine months ended September 30, 2021 and 2020. |
Redeemable Noncontrolling Inter
Redeemable Noncontrolling Interest | 9 Months Ended |
Sep. 30, 2021 | |
Redeemable Noncontrolling Interest | |
Redeemable Noncontrolling Interest | 11. Redeemable Noncontrolling Interest On December 26, 2018, the Company, together with Wuxi Jintou Huicun Investment Enterprise, a limited partnership organized under Chinese law (“Wuxi LP”) established CASI Wuxi to build and operate a manufacturing facility in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The Company holds 80% of the equity interests in CASI Wuxi and will invest, over time, $80 million in CASI Wuxi. The Company’s investment will consist of (i) $21 million in cash (paid in February 2019), (ii) a transfer of selected ANDAs valued at $30 million (transferred in May 2019), and (iii) an additional $29 million cash payment within three years from the date of establishment of CASI Wuxi. 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. Changes in redeemable noncontrolling interest during the three and nine month periods ended September 30, 2021 and 2020 are as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2021 2020 2021 2020 Balance at beginning of period $ 22,697 $ 21,074 $ 22,033 $ 20,670 Cash contribution by Wuxi LP — — Share of CASI Wuxi net loss (314) (309) (980) (584) Accretion of redeemable noncontrolling interest 519 506 1,586 1,185 Foreign currency translation adjustment 5 — 268 — Balance at end of period $ 22,907 $ 21,271 $ 22,907 $ 21,271 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 12. Stockholders’ Equity March 2021 Underwritten Public Offering On March 26, 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. Common Stock Sales Agreements 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. During the nine months ended September 30, 2021, the Company has not offered and sold any shares of common stock under the Sales Agreement. On July 19, 2019, the Company entered into an Open Market Sale Agreement SM As of September 30, 2021, the outstanding and exercisable exercise |
Costs of Revenues
Costs of Revenues | 9 Months Ended |
Sep. 30, 2021 | |
Costs of Revenues | |
Costs of Revenues | 13. Costs of Revenues Costs of revenues consists primarily of the cost of inventories of EVOMELA and sales-based royalties related to the sale of EVOMELA. The Company is obligated to pay 20% of the Company’s revenue from EVOMELA as royalties for a period of 10 years after the commercial launch of the products in 2019. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Net Loss Per Share | |
Net Loss Per Share | 14. Net Loss Per Share The following table sets forth the basic and diluted net loss per share computation and provides a reconciliation of the numerator and denominator for the periods presented: Three Months Ended September 30, Nine Months Ended September 30, (In thousands, except share and per share data) 2021 2020 2021 2020 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (10,224) $ (16,953) $ (31,053) $ (34,088) Denominator: Weighted average number of common shares 139,797,487 117,940,405 134,861,366 105,922,281 Denominator for basic and diluted net loss per share calculation 139,797,487 117,940,405 134,861,366 105,922,281 Net loss per share — Basic and diluted $ (0.07) $ (0.14) $ (0.23) $ (0.32) As of September 30, 2021, and 2020, outstanding stock options totaling 31,357,040 and 15,956,030, 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. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 15. Stock-Based Compensation On June 15, 2021, the 2021 Long-Term Incentive Plan (the “2021 Plan”) was approved by the Company's stockholders to replace the Company’s 2011 Long-Term Incentive Plan (the “2011 Plan”). Currently, the 2021 Plan is administered by the Company’s compensation committee. The maximum number of shares of Common Stock that are available for grants and awards equals to 20,000,000 shares of Common Stock, which includes 10,726,673 shares of Common Stock remaining under the Company’s 2011 Long-Term Incentive Plan (the “2011 Plan”) as of April 12, 2021. As of September 30, 2021, a total of 12,405,448 shares remained available for grant under the Company’s 2021 Long-Term Incentive Plan. The Company’s net loss for the nine months ended September 30, 2021 and 2020 includes $5.1 million and $5.7 million, respectively, of the Company’s share-based compensation. 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: Nine Months Ended September 30, (In thousands) 2021 2020 Research and development $ 251 $ 123 Sales and Marketing 212 — General and administrative 4,596 5,562 Share-based compensation expense $ 5,059 $ 5,685 Compensation expense related to stock options is recognized over the requisite service period, which is generally the option vesting term of up to five years. Awards with performance conditions are expensed when it is probable that the performance condition will be achieved. For the nine month periods ended September 30, 2021 and 2020, $1,056,000 and $13,000 was expensed for stock option awards with performance conditions that were probable during the period, respectively. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of service based and performance-based stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free interest rate, expected dividend yield, expected volatility, and the expected life of the award. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the nine month periods ended September 30, 2021 and 2020: Nine Months Ended September 30, 2021 2020 Expected volatility 79.72 % 77.71 % Range of expected volatility 76.64% to 81.5 % 75.84% to 81.63 % Range of risk free interest rate 0.72% to 1.22 % 0.31% to 1.77 % Expected term of option 6.18 years 6.03 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the nine month periods ended September 30, 2021 and 2020 were $1.05 and $1.96, respectively. On June 15, 2021, the Board approved a grant of stock options to Wei-Wu He. The grant consists of 4 million shares time-based and 4 million shares performance-based stock options. A summary of changes in options under the Company’s stock option plans during the nine month period ended September 30, 2021 is as follows: Weighted Average Number of Options Exercise Price Outstanding at December 31, 2020 16,746,238 $ 2.71 Exercised — $ — Granted 15,989,552 $ 1.57 Expired (343,750) $ 4.76 Forfeited (1,035,000) $ 2.65 Cancelled — $ — Outstanding at September 30, 2021 31,357,040 $ 2.11 Vested and expected to vest at September 30, 2021 31,357,040 $ 2.11 Exercisable at September 30, 2021 14,110,876 $ 2.54 Cash received from option exercises under all share-based payment arrangements for the nine month periods ended September 30, 2021 and 2020 was $0 million and $3.9 million, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Taxes | |
Income Taxes | 16. Income Taxes At December 31, 2020, the Company had a $2.1 million unrecognized tax benefit. The Company recorded a full valuation allowance on the deferred tax asset after offsetting unrecognized tax benefit recognized in the consolidated financial statements as of December 31, 2020. During the nine months ended September 30, 2021, there were no material changes to the measurement of unrecognized tax benefits in various tax jurisdictions. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 17. Fair Value Measurements The majority of the Company’s financial instruments (consisting 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. The Company’s investments in equity securities are carried at fair value, and investments in convertible loans are carried at fair value (see Note 4). 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. 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 4). 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 4). The fair value of the warrants was measured using observable market-based inputs other than quoted prices in active markets for identical assets or liabilities, 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 a privately held UK 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 4) using Level 3 input. The Company has an investment in the convertible debt of a privately held California 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 4) using Level 3 input. The Company uses the Binomial model to estimate the fair value of the convertible debt. The following tables present the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of September 30, 2021 and December 31, 2020, by level within the fair value hierarchy: (In thousands) Fair Value at Description September 30, 2021 Level 1 Level 2 Level 3 Investments in Current and non-Current Assets Investments in common stock $ 9,503 $ 9,503 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 352 $ — $ 352 $ — Investment in convertible loan - AFS $ 264 $ — $ — $ 264 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,589 $ — $ — $ 5,589 (In thousands) Fair Value at Description December 31, 2020 Level 1 Level 2 Level 3 Investments in 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 June 30, 2021, the Company remeasured the investment in equity securities in Black Belt (see Note 4) to the fair value of $1,385,000. 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 Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company has no non-financial assets and liabilities |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions | |
Related Party Transactions | 18. Related Party Transactions Juventas. Spectrum/Acrotech ® ® ® 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 nine months ended September 30, 2021 and 2020, the Company recognized rent expense of $60,000 and $108,000, respectively. March 2021 Underwritten Public Offering Transactions. ETP Global Fund L.P. (“ETP Global”), whose founding and managing member is CASI's Chairman and CEO, 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 Global, which is a current shareholder of CASI, purchased 3,000,000 shares at the public offering price of $2.05 per share for a total of $6.15 million. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2021 | |
Commitments | |
Commitments | 19. Commitments In conjunction with the Cleave agreement entered into during 2021 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of September 30, 2021, no milestones have been achieved. In conjunction with the BioInvent agreement entered into during 2020 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of September 30, 2021, no milestones have been achieved. In conjunction with the Black Belt agreement entered into during 2019 (see Note 2), 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 ($298,000) in August 2021. As of September 30, 2021, no other milestones have been achieved. In conjunction with the Pharmathen agreement entered into during 2019 (see Note 2), the Company is responsible for one remaining milestone payment. As of September 30, 2021, the remaining milestone has not been achieved. In conjunction with the Laurus Labs agreement entered into during 2018, the Company is responsible for certain remaining milestone payments. As of September 30, 2021, the remaining milestones have not been met. In November 2019, CASI Wuxi entered into a lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility. On August 27, 2020, CASI Wuxi entered into a Construction Project Contract (the "Construction Contract") with China Electronic System Engineering No. 2 Construction Co., Ltd. ("China Engineering"). Pursuant to the Construction Contract, CASI Wuxi will pay a contract price of RMB 74,588,000 (equivalent to $10,923,000) to retain China Engineering to complete the phase 1 project of CASI Wuxi's research and development production base, consisting of construction and installation of a combined factory building, warehouse, guard house and public works. As of September 30, 2021, the commitment under the Construction Contract was RMB 66,688,000 ($10,320,000). The estimated completion date is October 2023. In April 2021, CASI Wuxi entered into a freeze dryer and filling line equipments production agreement with Shanghai Dong Fu Long Technology Limited Co. in the total amount of RMB15,500,000 (equivalent to $2,400,000). The Company paid the deposit of RMB 4,650,000 ($720,000). As of September 30, 2021, the remaining RMB 9,670,000 ($1,500,000) has not been paid. RMB 3,470,000 ($540,000) will be due when CASI obtains quality acceptance approval, another RMB 4,650,000 ($720,000) due when CASI obtains acceptance report (SAT report), and last RMB 1,550,000 ($240,000) due when CASI receives guarantee from the bank. This last 10% payment is subject to quality acceptance condition. Their bank will issue a guarantee document to CASI. After one year following the SAT report, if there is no quality issue exists, the bank will unfreeze the 10% fund to Dong Fu Long. In August 2021, CASI Wuxi entered into a construction agreement with China Engineering in the total amount of RMB 28,800,000 (equivalent to $4,470,000) for WuXi factory building remodelling and installation. As of September 30, 2021, the commitment under the agreement was RMB 20,000,000 ($3,100,000). In September 2021, CASI Wuxi entered into a construction agreement with China Engineering in the total amount of RMB 11,700,000 (equivalent to $1,811,000) for supply chain & warehouse remodelling and installation. As of September 30, 2021, the commitment outstanding under the agreement was RMB 9,995,000 ($1,547,000). 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 | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events | |
Subsequent Events | 20. Subsequent Events On October 29, 2021, the Company has entered into a common stock sales agreement (“stock sales agreement”), with H.C. Wainwright & Co., LLC (“Wainwright”), relating to shares of common stock of the Company, $0.01 par value per share. In accordance with the terms of the sales agreement, the Company may offer and sell shares of common stock having an aggregate offering price of not more than $20,000,000. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Revenue Recognition | Revenue Recognition Product sales recognized in the consolidated statements of operations 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. As of September 30, 2021, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of September 30, 2021. |
Use of Estimates | Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to recoverability of operating lease right-of-use assets, intangible assets and long-term investments, net realizable value and obsolescence allowance for inventory, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments. 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. |
Investment in equity securiti_2
Investment in equity securities, at fair value and long-term investments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Investment in equity securities, at fair value and long-term investments | |
Schedule of investment | Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains (losses) value MaxCyte - equity interest Investment $ — $ 4,591 $ 4,591 BioInvent - equity interest Investment $ 5,661 $ (749) $ 4,912 Total $ 9,503 |
Schedule of components of long-term investments | September 30, December 31, (In thousands) 2021 2020 Available-for-sale debt securities: Black Belt Tx Limited - convertible loan $ 264 $ 83 Securities measured at fair value: BioInvent International AB - warrants 352 840 Cleave Therapeutics, Inc. - convertible loan 5,589 — Equity securities without readily determinable fair value: Black Belt Tx Limited - equity interest 1,385 2,250 Juventas Cell Therapy Ltd - equity interest 26,375 26,059 Juventas Cell Therapy Ltd - put option 212 210 Total $ 34,177 $ 29,442 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventories | |
Schedule of components of inventories | (In thousands) September 30, 2021 December 31, 2020 Finished goods $ 1,727 $ 1,356 Raw materials — — Total $ 1,727 $ 1,356 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Schedule of right of use assets and liabilities on condensed balance sheet | September 30, December 31, (In thousands) 2021 2020 Right of use assets $ 9,499 $ 8,696 Accrued and other current liabilities $ 1,213 $ 939 Other liabilities 1,434 965 Total lease liabilities $ 2,647 $ 1,904 |
Schedule of supplemental cash flow information | Nine Months Ended September 30, (In thousands) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,087 $ 1,064 Right of use assets obtained in exchange for lease obligations: $ 1,661 $ 1,030 |
Schedule of future undiscounted cash flows | (In thousands) 2021 (remaining three months) $ 355 2022 1,157 2023 803 Thereafter 373 Total 2,688 Discount factor (41) Lease liability 2,647 Amounts due within 12 months 1,213 Non-current lease liability $ 1,434 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Intangible Assets | |
Schedule of net definite-lived intangible assets | (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 15,832 (3,540) 13 years Others 197 (131) 5 years Total $ 16,029 $ (3,671) |
Schedule of changes in intangible assets | (In thousands) Balance as of December 31, 2020 $ 13,210 Amortization expense (1,009) Foreign currency translation adjustment 157 Balance as of September 30, 2021 $ 12,358 |
Schedule of expected future amortization expense | (In thousands) 2021 (remaining three months) $ 334 2022 1,334 2023 1,334 2024 1,303 2025 1,303 2026 and thereafter 6,750 |
Redeemable Noncontrolling Int_2
Redeemable Noncontrolling Interest (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Redeemable Noncontrolling Interest | |
Schedule of changes in redeemable noncontrolling interest | Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2021 2020 2021 2020 Balance at beginning of period $ 22,697 $ 21,074 $ 22,033 $ 20,670 Cash contribution by Wuxi LP — — Share of CASI Wuxi net loss (314) (309) (980) (584) Accretion of redeemable noncontrolling interest 519 506 1,586 1,185 Foreign currency translation adjustment 5 — 268 — Balance at end of period $ 22,907 $ 21,271 $ 22,907 $ 21,271 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share | Three Months Ended September 30, Nine Months Ended September 30, (In thousands, except share and per share data) 2021 2020 2021 2020 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (10,224) $ (16,953) $ (31,053) $ (34,088) Denominator: Weighted average number of common shares 139,797,487 117,940,405 134,861,366 105,922,281 Denominator for basic and diluted net loss per share calculation 139,797,487 117,940,405 134,861,366 105,922,281 Net loss per share — Basic and diluted $ (0.07) $ (0.14) $ (0.23) $ (0.32) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation | |
Schedule of compensation expense | Nine Months Ended September 30, (In thousands) 2021 2020 Research and development $ 251 $ 123 Sales and Marketing 212 — General and administrative 4,596 5,562 Share-based compensation expense $ 5,059 $ 5,685 |
Schedule of weighted-average assumptions used in valuing the stock options | Nine Months Ended September 30, 2021 2020 Expected volatility 79.72 % 77.71 % Range of expected volatility 76.64% to 81.5 % 75.84% to 81.63 % Range of risk free interest rate 0.72% to 1.22 % 0.31% to 1.77 % Expected term of option 6.18 years 6.03 years Expected dividend yield 0.00 % 0.00 % |
Schedule of stock option plans and of changes in options outstanding under the plans | Weighted Average Number of Options Exercise Price Outstanding at December 31, 2020 16,746,238 $ 2.71 Exercised — $ — Granted 15,989,552 $ 1.57 Expired (343,750) $ 4.76 Forfeited (1,035,000) $ 2.65 Cancelled — $ — Outstanding at September 30, 2021 31,357,040 $ 2.11 Vested and expected to vest at September 30, 2021 31,357,040 $ 2.11 Exercisable at September 30, 2021 14,110,876 $ 2.54 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities accounted for at fair value on a recurring basis | The following tables present the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of September 30, 2021 and December 31, 2020, by level within the fair value hierarchy: (In thousands) Fair Value at Description September 30, 2021 Level 1 Level 2 Level 3 Investments in Current and non-Current Assets Investments in common stock $ 9,503 $ 9,503 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 352 $ — $ 352 $ — Investment in convertible loan - AFS $ 264 $ — $ — $ 264 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,589 $ — $ — $ 5,589 (In thousands) Fair Value at Description December 31, 2020 Level 1 Level 2 Level 3 Investments in 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 |
Basis of Presentation, Organi_2
Basis of Presentation, Organization and Principal Activities - Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2021segment | |
Description of Business and Basis of Presentation | |
Number of operating segments | 1 |
CASI China | |
Description of Business and Basis of Presentation | |
Percentage of ownership interest held by the parent entity in the non stock subsidiary | 100.00% |
CASI Wuxi | |
Description of Business and Basis of Presentation | |
Percentage of ownership interest held by the parent entity in the non stock subsidiary | 80.00% |
Basis of Presentation, Organi_3
Basis of Presentation, Organization and Principal Activities - Liquidity Risks and Management's Plans (Details) | Oct. 29, 2021USD ($)$ / shares | Mar. 26, 2021USD ($)shares | Sep. 30, 2021USD ($)person$ / shares | Dec. 31, 2020USD ($)$ / shares |
Description of Business and Basis of Presentation | ||||
Shares issued | shares | 15,853,658 | |||
Common Stock, Par Value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Aggregate offering price | $ 32,500,000 | |||
Cash and cash equivalents | $ 53,126,000 | $ 57,064,000 | ||
Subsequent Event [Member] | H.C. Wainwright Co., LLC | ||||
Description of Business and Basis of Presentation | ||||
Common Stock, Par Value (in dollars per share) | $ / shares | $ 0.01 | |||
Minimum | ||||
Description of Business and Basis of Presentation | ||||
Number of hematology and oncology sales and marketing specialist | person | 100 | |||
Maximum | Subsequent Event [Member] | H.C. Wainwright Co., LLC | ||||
Description of Business and Basis of Presentation | ||||
Aggregate offering price | $ 20,000,000 |
License and Distribution Agre_2
License and Distribution Agreements (Details) | Oct. 29, 2019 | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Nov. 30, 2020USD ($) | Apr. 30, 2019USD ($) | Apr. 30, 2019EUR (€) | Mar. 31, 2019 | Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2021EUR (€) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2019EUR (€) | Jun. 30, 2021EUR (€) |
License and Distribution Agreements | |||||||||||||||||
Acquired in-process research and development | $ 0 | $ 10,862,000 | $ 6,555,000 | $ 11,943,000 | |||||||||||||
Revenues | 8,112,000 | 4,242,000 | 21,010,000 | 10,319,000 | |||||||||||||
China Resources Guokang Pharmaceuticals Co., Ltd | |||||||||||||||||
License and Distribution Agreements | |||||||||||||||||
Non Royalty Exclusive Distribution Period | 3 years | ||||||||||||||||
Revenues | $ 8,100,000 | $ 4,200,000 | 20,900,000 | $ 10,200,000 | |||||||||||||
Pharmathen Global BV | |||||||||||||||||
License and Distribution Agreements | |||||||||||||||||
Upfront payment | € | € 1,000,000 | ||||||||||||||||
Non Royalty Exclusive Distribution Period | 10 years | ||||||||||||||||
Additional milestone payments paid | $ 1,700,000 | € 1,500,000 | |||||||||||||||
Non-royalty exclusive distribution period at agreed cost | 3 years | ||||||||||||||||
Pharmathen Global BV | Maximum | |||||||||||||||||
License and Distribution Agreements | |||||||||||||||||
Additional milestone payments paid | € | 2,000,000 | ||||||||||||||||
Black Belt Therapeutics Ltd | |||||||||||||||||
License and Distribution Agreements | |||||||||||||||||
Upfront payment | $ 5,700,000 | € 5,000,000 | |||||||||||||||
Milestone payment | $ 750,000 | 298,000 | € 250,000 | ||||||||||||||
Accrued milestone payment | $ 298,000 | € 250,000 | |||||||||||||||
In-process research and development expensed | 1,060,000 | € 5,000,000 | |||||||||||||||
Cleave Therapeutics, Inc | |||||||||||||||||
License and Distribution Agreements | |||||||||||||||||
Upfront payment | $ 5,500,000 | ||||||||||||||||
Acquired in-process research and development | $ 5,500,000 | ||||||||||||||||
Potential milestone of up to | $ 74,000,000 | ||||||||||||||||
BioInvent International AB | |||||||||||||||||
License and Distribution Agreements | |||||||||||||||||
Upfront payment | $ 5,900,000 | ||||||||||||||||
Potential milestones and royalties of up to | $ 83,000,000 | ||||||||||||||||
Acquired in-process research and development | $ 5,900,000 |
Investment in equity securiti_3
Investment in equity securities, at fair value and long-term investments (Details) kr in Millions | Oct. 26, 2021USD ($) | Oct. 26, 2021CNY (¥) | Sep. 29, 2020CNY (¥) | Jul. 31, 2021EUR (€) | Mar. 31, 2021USD ($) | 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 (€) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Oct. 31, 2020SEK (kr) | Jul. 31, 2020EUR (€) |
Loan to related party | $ 10,033,000 | |||||||||||||||||||||||||||
Change in fair value of investment in equity securities | $ (3,729,000) | $ 862,000 | $ (294,000) | $ 1,171,000 | ||||||||||||||||||||||||
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 | $ 352,000 | $ 352,000 | ||||||||||||||||||||||||||
Warrants expected life | 4 years 1 month 28 days | 4 years 1 month 28 days | ||||||||||||||||||||||||||
Upfront payment | $ 5,900,000 | |||||||||||||||||||||||||||
BioInvent International AB | Volatility | ||||||||||||||||||||||||||||
Warrants , Measurement Input | 44.95 | 44.95 | ||||||||||||||||||||||||||
BioInvent International AB | Risk Free Interest Rate | ||||||||||||||||||||||||||||
Warrants , Measurement Input | 0.0456 | 0.0456 | ||||||||||||||||||||||||||
Alesta Tx | ||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 1,385,000 | $ 1,385,000 | ||||||||||||||||||||||||||
Equity ownership (as a percent) | 14.10% | |||||||||||||||||||||||||||
Percentage of fully diluted capital | 8.30% | 8.30% | ||||||||||||||||||||||||||
Loan amount | € | € 217,166 | |||||||||||||||||||||||||||
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% | 12.90% | ||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | ||||||||||||||||||||||||||||
Payments to acquire equity Investments | $ 11,788,000 | ¥ 80,000,000 | ||||||||||||||||||||||||||
Equity ownership (as a percent) | 16.45% | 16.327% | 16.327% | 16.45% | 16.45% | |||||||||||||||||||||||
Interest rate (as a percent) | 8.00% | 8.00% | 8.00% | |||||||||||||||||||||||||
Additional equity investment | ¥ | ¥ 70,000,000 | |||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Equity ownership (as a percent) | 12.01% | 12.01% | ||||||||||||||||||||||||||
Proceeds from fund raising | $ 63,000,000 | ¥ 410,000,000 | ||||||||||||||||||||||||||
Juventas Cell Therapy Ltd. | June 2020 Loan Agreement | ||||||||||||||||||||||||||||
Term of loan provided | 1 year | 1 year | ||||||||||||||||||||||||||
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 rate (as a percent) | 20.00% | 20.00% | 20.00% | |||||||||||||||||||||||||
Loans advanced to related party | $ 5,790,000 | ¥ 40,000,000 | ||||||||||||||||||||||||||
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% | |||||||||||||||||||||||||
Interest rate (as a percent) | 6.00% | 6.00% | 6.00% | |||||||||||||||||||||||||
Term of loan | 3 years | 3 years | 3 years | |||||||||||||||||||||||||
Loan to be advanced | $ 250,000 | € 211,800 | ||||||||||||||||||||||||||
Convertible loan repaid | € | € 146,566 | |||||||||||||||||||||||||||
Black Belt Tx Limited | Black Belt Tx Loan - Tranche One | ||||||||||||||||||||||||||||
Convertible loan tranches repaid | 70,600 | $ 83,000 | € 70,600 | |||||||||||||||||||||||||
Black Belt Tx Limited | Black Belt Tx Loan - Tranche Two | ||||||||||||||||||||||||||||
Convertible loan tranches repaid | 70,600 | $ 86,000 | € 70,600 | |||||||||||||||||||||||||
Convertible loan interest repaid | € | € 5,366 | |||||||||||||||||||||||||||
Cleave Therapeutics, Inc | ||||||||||||||||||||||||||||
Term of loan provided | 3 years | |||||||||||||||||||||||||||
Interest rate (as a percent) | 3.00% | |||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 2,700,000 | |||||||||||||||||||||||||||
Level 1 | MaxCyte Inc. | ||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 4,600,000 | $ 4,600,000 | ||||||||||||||||||||||||||
Level 1 | BioInvent International AB | ||||||||||||||||||||||||||||
Fair value of additional equity interest | $ 4,900,000 | $ 4,900,000 | $ 6,600,000 |
Investment in equity securiti_4
Investment in equity securities, at fair value and long-term investments - Summary of Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Gross unrealized gains (losses) equity securities at fair value | $ (3,687) | $ 1,978 | $ (205) | $ 2,287 |
Common Stock | ||||
Equity securities at fair value | 9,503 | 9,503 | ||
Common Stock | MaxCyte Inc. | ||||
Gross unrealized gains (losses) equity securities at fair value | 4,591 | |||
Equity securities at fair value | 4,591 | 4,591 | ||
Common Stock | BioInvent International AB | ||||
Cost | 5,661 | 5,661 | ||
Gross unrealized gains (losses) equity securities at fair value | (749) | |||
Equity securities at fair value | $ 4,912 | $ 4,912 |
Investment in equity securiti_5
Investment in equity securities, at fair value and long-term investments - Summary of Long-term investments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Schedule Of Long Term Investments | ||
Total | $ 34,177 | $ 29,442 |
Black Belt Tx Limited | Convertible loan | ||
Schedule Of Long Term Investments | ||
Available-for-sale debt securities | 264 | 83 |
Black Belt Tx Limited | Equity Securities | ||
Schedule Of Long Term Investments | ||
Equity securities without readily determinable fair value | 1,385 | 2,250 |
Juventas Cell Therapy Ltd. | Equity Securities | ||
Schedule Of Long Term Investments | ||
Equity securities without readily determinable fair value | 26,375 | 26,059 |
Juventas Cell Therapy Ltd. | Put option | ||
Schedule Of Long Term Investments | ||
Equity securities without readily determinable fair value | 212 | 210 |
BioInvent International AB | Warrants | ||
Schedule Of Long Term Investments | ||
Securities measured at fair value | 352 | $ 840 |
Cleave Therapeutics, Inc | Convertible loan | ||
Schedule Of Long Term Investments | ||
Securities measured at fair value | $ 5,589 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Inventories | |||||
Finished goods | $ 1,727 | $ 1,727 | $ 1,356 | ||
Total | 1,727 | 1,727 | $ 1,356 | ||
Inventory write down | $ 0 | $ 0 | $ 0 | $ 0 |
Leases - (Details)
Leases - (Details) ¥ in Millions | 1 Months Ended | 9 Months Ended | ||
Nov. 30, 2019USD ($)m² | Nov. 30, 2019CNY (¥)m² | Sep. 30, 2021USD ($)lease | Sep. 30, 2020USD ($) | |
Number of Operating Leases | lease | 8 | |||
Weighted average remaining lease term | 34 years 10 months 20 days | |||
Weighted average discount rates | 3.58% | |||
Rent expenses | $ 1,158,000 | $ 1,153,000 | ||
Variable lease costs | 0 | 0 | ||
Sublease income | $ 0 | $ 0 | ||
CASI Wuxi | ||||
Term of lease contract | 50 years | 50 years | ||
Land parcel area (in square meters) | m² | 74,028.40 | 74,028.40 | ||
Prepaid lease payments for the land use right | $ 6,500,000 | ¥ 45 |
Leases - Right of Use Assets an
Leases - Right of Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Right of use assets | $ 9,499 | $ 8,696 |
Operating Lease, Liability | $ 2,647 | 1,904 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Right of use assets | |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent, Other Liabilities, Noncurrent | |
Accrued Liabilities-Current | ||
Operating Lease, Liability | $ 1,213 | 939 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued And Other Liabilities, Current | |
Other Liabilities-Long Term | ||
Operating Lease, Liability | $ 1,434 | $ 965 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows | $ 1,087 | $ 1,064 |
Right of use assets obtained in exchange for lease obligations | $ 1,661 | $ 1,030 |
Leases - Future Undiscounted Ca
Leases - Future Undiscounted Cash Flows (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Leases | ||
2021 (remaining three months) | $ 355 | |
2022 | 1,157 | |
2023 | 803 | |
Thereafter | 373 | |
Total | 2,688 | |
Discount factor | (41) | |
Lease liability | 2,647 | $ 1,904 |
Amounts due within 12 months | 1,213 | |
Non-current lease liability | $ 1,434 |
Intangible Assets (Details)
Intangible Assets (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Feb. 29, 2020USD ($)item | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Finite-Lived Intangible Assets | ||||||
Net book value | $ 12,358,000 | $ 12,358,000 | $ 13,210,000 | |||
Gain (Loss) | $ 0 | $ 0 | $ 0 | $ 450,000 | ||
ANDA | ||||||
Finite-Lived Intangible Assets | ||||||
Estimated useful lives | 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 | |||||
Gain (Loss) | 450,000 | |||||
Remaining potential milestone of up to | $ 1,000,000 |
Intangible Assets - Net Definit
Intangible Assets - Net Definite-lived Intangible Assets (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Finite-Lived Intangible Assets | |
Purchase Price | $ 16,029 |
Accumulated Amortization | (3,671) |
ANDA | |
Finite-Lived Intangible Assets | |
Purchase Price | 15,832 |
Accumulated Amortization | $ (3,540) |
Estimated useful lives | 13 years |
Others | |
Finite-Lived Intangible Assets | |
Purchase Price | $ 197 |
Accumulated Amortization | $ (131) |
Estimated useful lives | 5 years |
Intangible Assets - Intangible
Intangible Assets - Intangible Assets Rollforward (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Intangible Assets | |
Beginning balance | $ 13,210 |
Amortization expenses | (1,009) |
Foreign currency translation adjustments | 157 |
Ending balance | $ 12,358 |
Intangible Assets - Expected Fu
Intangible Assets - Expected Future Amortization Expense (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Intangible Assets | |
2021 (remaining three months) | $ 334 |
2022 | 1,334 |
2023 | 1,334 |
2024 | 1,303 |
2025 | 1,303 |
2026 and thereafter | $ 6,750 |
Grants (Details)
Grants (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 17 Months Ended | |||||
Apr. 30, 2020USD ($) | Apr. 30, 2020CNY (¥) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021CNY (¥) | Sep. 30, 2021CNY (¥) | Dec. 31, 2020USD ($) | |
Grants | |||||||||
Deferred income | $ 2,342,000 | $ 2,342,000 | $ 2,351,000 | ||||||
CASI Wuxi | |||||||||
Grants | |||||||||
Government grant received | $ 2,200,000 | ¥ 15,900,000 | |||||||
Recognized deferred income | ¥ | ¥ 481,000 | ||||||||
Deferred income | 2,400,000 | 2,400,000 | ¥ 15,400,000 | ||||||
Other income | $ 12,000 | $ 12,000 | $ 37,000 | $ 23,000 |
Bank Borrowings (Details)
Bank Borrowings (Details) ¥ in Millions | Sep. 02, 2021USD ($) | Sep. 02, 2021CNY (¥) | Feb. 03, 2021USD ($) | Feb. 03, 2021CNY (¥) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020CNY (¥) | Nov. 03, 2020USD ($) | Nov. 03, 2020CNY (¥) |
Bank Borrowings | ||||||||||||
Amount matured | $ 709,000 | |||||||||||
Interest expense | $ 900 | $ 1,200 | 2,900 | $ 1,900 | ||||||||
China CITIC Bank Corporation Limited | ||||||||||||
Bank Borrowings | ||||||||||||
Maximum Borrowing | $ 1,500,000 | ¥ 10 | ||||||||||
Amount outstanding | $ 826,000 | ¥ 5.4 | ||||||||||
Interest rate | 3.72% | 3.72% | 3.35% | 3.35% | ||||||||
Amount matured | $ 700,000 | ¥ 4.6 | ||||||||||
Repaid bank borrowings | $ 500,000 | ¥ 3 | ||||||||||
Interest expense | $ 12,000 | $ 37,000 |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | Apr. 29, 2020 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Apr. 27, 2020 |
Notes Payable | |||||||
Interest expense | $ 900 | $ 1,200 | $ 2,900 | $ 1,900 | |||
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 |
Redeemable Noncontrolling Int_3
Redeemable Noncontrolling Interest (Details) $ in Millions | 1 Months Ended | 9 Months Ended | |||
May 31, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 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% | ||||
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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Redeemable Noncontrolling Interest | ||||
Balance at beginning of period | $ 22,697 | $ 21,074 | $ 22,033 | $ 20,670 |
Cash contribution by Wuxi LP | 0 | 0 | ||
Share of CASI Wuxi net loss | (314) | (309) | (980) | (584) |
Accretion to redeemable non-controlling interest redemption value | 519 | 506 | 1,586 | 1,185 |
Foreign currency translation adjustment | 5 | 268 | ||
Balance at end of period | $ 22,907 | $ 21,271 | $ 22,907 | $ 21,271 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 26, 2021 | Jul. 19, 2019 | Sep. 30, 2021 | Sep. 24, 2021 | Sep. 30, 2018 |
Shares issued | 15,853,658 | ||||
Offering price per share | $ 2.05 | ||||
Gross proceeds from the offering | $ 32.5 | ||||
Warrants outstanding (in shares) | 6,172,832 | ||||
Warrants issued (in shares) | 8,271,709 | ||||
Warrants expired (in shares) | 2,098,877 | ||||
Warrants exercisable (in shares) | 6,172,832 | ||||
Warrants outstanding, exercise price | $ 3.69 | ||||
Warrants exercisable, exercise price | $ 3.69 | ||||
Open Market Sale Agreement | |||||
Maximum Sales Price from Issuance of Common Stock | $ 30 | ||||
Amendment To Open Sale Agreement | |||||
Maximum Sales Price from Issuance of Common Stock | $ 20 |
Costs of Revenues (Details)
Costs of Revenues (Details) - EVOMELA | 9 Months Ended |
Sep. 30, 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 - Basic and
Net Loss Per Share - Basic and diluted net loss per share computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator: | ||||
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (10,224) | $ (16,953) | $ (31,053) | $ (34,088) |
Denominator: | ||||
Weighted average number of common shares | 139,797,487 | 117,940,405 | 134,861,366 | 105,922,281 |
Net loss per share (basic and diluted) | $ (0.07) | $ (0.14) | $ (0.23) | $ (0.32) |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Options | ||
Antidilutive securities excluded from computation of earnings per share amount | 31,357,040 | 15,956,030 |
Warrant | ||
Antidilutive securities excluded from computation of earnings per share amount | 6,172,832 | 8,271,709 |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 5,059 | $ 5,685 |
Research and Development Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 251 | 123 |
Sales and Marketing | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 212 | |
General and Administrative Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 4,596 | $ 5,562 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted-Average Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-Based Compensation | ||
Expected volatility | 79.72% | 77.71% |
Range of expected volatility, Minimum | 76.64% | 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 | 1.22% | 1.77% |
Expected term of option | 6 years 2 months 4 days | 6 years 10 days |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Outstanding (Details) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding | |
Beginning Balance | shares | 16,746,238 |
Exercised | shares | 0 |
Granted | shares | 15,989,552 |
Expired | shares | (343,750) |
Forfeited | shares | (1,035,000) |
Cancelled | shares | 0 |
Ending Balance | shares | 31,357,040 |
Vested and expected to vest | shares | 31,357,040 |
Exercisable | shares | 14,110,876 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | |
Beginning balance | $ / shares | $ 2.71 |
Exercised | $ / shares | 0 |
Granted | $ / shares | 1.57 |
Expired | $ / shares | 4.76 |
Forfeited | $ / shares | 2.65 |
Cancelled | $ / shares | 0 |
Ending Balance | $ / shares | 2.11 |
Vested and expected to vest | $ / shares | 2.11 |
Exercisable | $ / shares | $ 2.54 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | Apr. 12, 2021 | Sep. 30, 2021 | Sep. 30, 2020 |
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 | 20,000,000 | ||
Share-based Compensation | $ 5,059,000 | $ 5,685,000 | |
Performance Share Based Compensation Expense | $ 1,056,000 | $ 13,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.05 | $ 1.96 | |
Share Based Payment Cash Received from Stock Option Exercises | $ 0 | $ 3,900,000 | |
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 | ||
Long Term Incentive Plan 2021 | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Common Stock, Capital Shares Reserved for Future Issuance | 12,405,448 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | Sep. 30, 2021 | Dec. 31, 2020 |
Income Taxes | ||
Unrecognized tax benefits | $ 0 | $ 2.1 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |
Non-financial assets, measured at fair value | $ 0 |
Non-financial liabilities, measured at fair value | 0 |
Non-recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |
Non-financial assets, measured at fair value | 0 |
Non-financial liabilities, measured at fair value | $ 0 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial and Non-Financial Assets and Liabilities (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2021 | |
Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in common stock | $ 9,503,000 | $ 9,309,000 | |
Investment in warrants -Designated as investment measured at FVTPL | 352,000 | 840,000 | |
Investment in convertible loan-AFS | 264,000 | 83,000 | |
Investment in convertible loan-Designated as investment measured at FVTPL | 5,589,000 | ||
Level 1 | Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in common stock | 9,503,000 | 9,309,000 | |
Investment in warrants -Designated as investment measured at FVTPL | 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 | 352,000 | 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 convertible loan-AFS | 264,000 | $ 83,000 | |
Investment in convertible loan-Designated as investment measured at FVTPL | $ 5,589,000 | ||
Black Belt Tx Limited | Non-recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | |||
Investment in equity securities using measurement alternative, fair value | $ 1,385,000 |
Related Party Transactions (Det
Related Party Transactions (Details) | Mar. 26, 2021USD ($)$ / sharesshares | Jul. 01, 2019CNY (¥) | Jul. 01, 2019USD ($) | Jan. 31, 2020USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2021CNY (¥) | Sep. 30, 2021USD ($) | Sep. 30, 2020CNY (¥) | Sep. 30, 2020USD ($) | Sep. 30, 2021CNY (¥) | Sep. 30, 2021USD ($) | Sep. 30, 2020CNY (¥) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Related Party Transaction | ||||||||||||||||
Shares issued | shares | 15,853,658 | |||||||||||||||
Offering price per share | $ / shares | $ 2.05 | |||||||||||||||
Net proceeds from issuance of common stock | $ 32,500,000 | |||||||||||||||
Spectrum/Acrotech | ||||||||||||||||
Related Party Transaction | ||||||||||||||||
Payable to related party | $ 200,000 | |||||||||||||||
Expense incurred | 2,600,000 | |||||||||||||||
Spectrum/Acrotech | EVOMELA | ||||||||||||||||
Related Party Transaction | ||||||||||||||||
Equity ownership (as a percent) | 4.90% | 4.90% | 4.90% | 4.90% | ||||||||||||
Purchase obligation | $ 9,200,000 | |||||||||||||||
BioCheck Inc. | ||||||||||||||||
Related Party Transaction | ||||||||||||||||
Term of lease contract | 1 year | |||||||||||||||
Lease payments | $ 12,000 | $ 5,000 | $ 60,000 | $ 108,000 | $ 144,000 | $ 60,000 | ||||||||||
Emerging Technology Partners LLC | Minimum | ||||||||||||||||
Related Party Transaction | ||||||||||||||||
Equity ownership (as a percent) | 5.00% | 5.00% | 5.00% | 5.00% | ||||||||||||
Juventas Cell Therapy Ltd. | ||||||||||||||||
Related Party Transaction | ||||||||||||||||
Term of lease contract | 1 year | 1 year | ||||||||||||||
Lease payments | ¥ 80,000 | $ 15,000 | ||||||||||||||
Lease income | ¥ 240,000 | $ 37,000 | ¥ 240,000 | $ 37,000 | ¥ 720,000 | $ 110,000 | ¥ 720,000 | $ 104,000 | ||||||||
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 (Details)
Commitments (Details) | 1 Months Ended | 9 Months Ended | |||||||||||||
Sep. 30, 2021USD ($) | Sep. 30, 2021CNY (¥) | Aug. 31, 2021USD ($) | Aug. 31, 2021CNY (¥) | Jun. 30, 2021USD ($) | Apr. 30, 2021USD ($) | Apr. 30, 2021CNY (¥) | Sep. 30, 2021USD ($)Milestone | Sep. 30, 2021EUR (€)Milestone | Sep. 30, 2020USD ($) | Sep. 30, 2021CNY (¥) | Jun. 30, 2021EUR (€) | Apr. 30, 2021CNY (¥) | Aug. 27, 2020USD ($) | Aug. 27, 2020CNY (¥) | |
Payment for property improvements | $ | $ 3,730,000 | $ 367,000 | |||||||||||||
CASI Wuxi | |||||||||||||||
Commission outstanding under construction contract | $ 10,320,000 | 10,320,000 | ¥ 66,688,000 | ||||||||||||
Construction project contract amount | $ 10,923,000 | ¥ 74,588,000 | |||||||||||||
CASI Wuxi | August 2021 Construction Agreement | |||||||||||||||
Contractual obligation | 3,100,000 | 3,100,000 | 20,000,000 | ||||||||||||
Payment for property improvements | $ 4,470,000 | ¥ 28,800,000 | |||||||||||||
CASI Wuxi | September 2021 Construction Agreement | |||||||||||||||
Contractual obligation | 1,547,000 | $ 1,547,000 | 9,995,000 | ||||||||||||
Payment for property improvements | 1,811,000 | ¥ 11,700,000 | |||||||||||||
Cleave Therapeutics, Inc | |||||||||||||||
Number of milestones achieved | 0 | 0 | |||||||||||||
BioInvent International AB | |||||||||||||||
Number of milestones achieved | 0 | 0 | |||||||||||||
Black Belt Therapeutics Ltd | |||||||||||||||
Number of milestones achieved | 0 | 0 | |||||||||||||
Milestone payment | $ 750,000 | $ 298,000 | € 250,000 | ||||||||||||
Accrued milestone payment | $ 298,000 | € 250,000 | |||||||||||||
Pharmathen Global BV | |||||||||||||||
Number of milestone payments yet to be paid | 1 | 1 | |||||||||||||
Shanghai Dong Fu Long Technology Limited Co. | CASI Wuxi | |||||||||||||||
Contractual obligation | 1,500,000 | $ 2,400,000 | $ 1,500,000 | 9,670,000 | ¥ 15,500,000 | ||||||||||
Payment of deposits | $ 720,000 | ¥ 4,650,000 | |||||||||||||
Shanghai Dong Fu Long Technology Limited Co. | CASI Wuxi | CASI obtains quality acceptance approval | |||||||||||||||
Contractual obligation | $ 540,000 | $ 540,000 | ¥ 3,470,000 | ||||||||||||
Percentage of contractual obligation withheld until certain criteria achieved | 10.00% | 10.00% | 10.00% | ||||||||||||
Shanghai Dong Fu Long Technology Limited Co. | CASI Wuxi | CASI obtains acceptance report (SAT Report) | |||||||||||||||
Contractual obligation | $ 720,000 | $ 720,000 | ¥ 4,650,000 | ||||||||||||
Shanghai Dong Fu Long Technology Limited Co. | CASI Wuxi | CASI receives guarantee from bank | |||||||||||||||
Contractual obligation | $ 240,000 | $ 240,000 | ¥ 1,550,000 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) | Oct. 29, 2021 | Mar. 26, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Subsequent Events | ||||
Common Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 | ||
Aggregate offering price | $ 32,500,000 | |||
Subsequent Events | H.C. Wainwright Co., LLC | ||||
Subsequent Events | ||||
Common Stock, Par Value (in dollars per share) | $ 0.01 | |||
Subsequent Events | Maximum | H.C. Wainwright Co., LLC | ||||
Subsequent Events | ||||
Aggregate offering price | $ 20,000,000 |