Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 11, 2020 | Jun. 30, 2019 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | CASI Pharmaceuticals, Inc. | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Central Index Key | 0000895051 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 194,144,774 | ||
Trading Symbol | CASI | ||
Entity Common Stock, Shares Outstanding | 99,023,760 | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Small Business | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 53,621 | $ 84,205 |
Investment in equity securities, at fair value | 625 | 912 |
Accounts receivable, net of $0 allowance for doubtful accounts | 1,293 | 0 |
Inventories | 4,542 | 283 |
Prepaid expenses and other | 1,420 | 7,165 |
Total current assets | 61,501 | 92,565 |
Property and equipment, net | 985 | 1,751 |
Intangible assets, net | 16,895 | 18,785 |
Long-term investments | 14,038 | 0 |
Right of use assets | 8,708 | 0 |
Other assets | 504 | 310 |
Total assets | 102,631 | 113,411 |
Current liabilities: | ||
Accounts payable | 5,113 | 968 |
Accrued liabilities | 2,834 | 1,406 |
Note payable, net of discount | 0 | 1,499 |
Total current liabilities | 7,947 | 3,873 |
Other liabilities | 1,019 | 74 |
Total liabilities | 8,966 | 3,947 |
Commitments and contingencies (Note 20) | ||
Redeemable noncontrolling interest, at redemption value (Note 11) | 20,670 | 0 |
Stockholders' equity: | ||
Preferred stock, $1.00 par value: 5,000,000 shares authorized and 0 shares issued and outstanding | 0 | 0 |
Common stock, $.01 par value: 250,000,000 shares and 170,000,000 shares authorized at December 31, 2019 and 2018, respectively; 97,851,243 shares and 95,366,813 shares issued at December 31, 2019 and 2018, respectively; 97,771,698 shares and 95,287,268 shares outstanding at December 31, 2019 and 2018, respectively | 979 | 954 |
Additional paid-in capital | 606,686 | 596,712 |
Treasury stock, at cost: 79,545 shares held at September 30, 2019 and December 31, 2018 | (8,034) | (8,034) |
Accumulated other comprehensive loss | (2,728) | (1,227) |
Accumulated deficit | (523,908) | (478,941) |
Total stockholders' equity | 72,995 | 109,464 |
Total liabilities, redeemable noncontrolling interest and stockholders' equity | $ 102,631 | $ 113,411 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Consolidated Balance Sheets | ||
Allowance for doubtful accounts | $ 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 | 170,000,000 |
Common Stock, Shares Issued (in shares) | 97,851,243 | 95,366,813 |
Common Stock, Shares Outstanding (in shares) | 97,771,698 | 95,287,268 |
Treasury stock, shares held (in shares) | 79,545 | 79,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | ||
Product sales | $ 4,063 | $ 0 |
Lease income | 68 | 0 |
Total revenues | 4,131 | 0 |
Costs and expenses: | ||
Costs of revenues | 3,935 | 0 |
Research and development | 9,748 | 8,507 |
General and administrative | 27,336 | 17,997 |
Selling and marketing | 3,103 | 0 |
Acquired in-process research and development | 6,967 | 687 |
Total cost and expenses | 51,089 | 27,191 |
Loss from operations | (46,958) | (27,191) |
Non-operating income/(expense): | ||
Interest income, net | 1,062 | 40 |
Foreign exchange gains | 817 | 0 |
Change in fair value of investment in equity securities | (288) | (320) |
Other income | 5 | 0 |
Net loss | (45,362) | (27,471) |
Less: loss attributable to redeemable noncontrolling interest | (395) | 0 |
Accretion to redeemable noncontrolling interest redemption value | 1,065 | 0 |
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (46,032) | $ (27,471) |
Net loss per share (basic and diluted) (in dollars per share) | $ (0.48) | $ (0.32) |
Weighted average number of common shares outstanding (basic and diluted) | 95,948 | 84,752 |
Comprehensive loss: | ||
Net loss | $ (45,362) | $ (27,471) |
Foreign currency translation adjustment | (1,501) | (1,227) |
Total comprehensive loss | (46,863) | (28,698) |
Less: Comprehensive loss attributable to redeemable noncontrolling interest | (395) | 0 |
Comprehensive loss attributable to common stockholders | $ (46,468) | $ (28,698) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 0 | $ 699 | $ (8,034) | $ 498,578 | $ 0 | $ (452,702) | $ 38,541 |
Balance (in Shares) at Dec. 31, 2017 | 0 | 69,822,080 | |||||
Correction of immaterial error in prior year and cumulative effect adjustment due to the adoption of ASU 2016-01 | $ 0 | $ 0 | 0 | 0 | 0 | 1,232 | 1,232 |
Issuance of common stock and warrants pursuant to financing agreements | $ 0 | $ 226 | 0 | 87,764 | 0 | 0 | 87,990 |
Issuance of common stock and warrants pursuant to financing agreements (in shares) | 0 | 22,571,605 | |||||
Issuance of common stock for options exercised | $ 0 | $ 1 | 0 | 257 | 0 | 0 | 258 |
Issuance of common stock for options exercised (in shares) | 0 | 139,683 | |||||
Repurchase of stock options to satisfy tax withholding obligations | $ 0 | $ 0 | 0 | (117) | 0 | 0 | (117) |
Issuance of common stock from exercise of warrants | $ 0 | $ 28 | 0 | 4,933 | 0 | 0 | 4,961 |
Issuance of common stock from exercise of warrants (in shares) | 0 | 2,753,900 | |||||
Stock issuance costs | $ 0 | $ 0 | 0 | (822) | 0 | 0 | (822) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 0 | 6,119 | 0 | 0 | 6,119 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | (1,227) | 0 | (1,227) |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | 0 | 0 | 0 | (27,471) | (27,471) |
Balance at Dec. 31, 2018 | $ 0 | $ 954 | (8,034) | 596,712 | (1,227) | (478,941) | 109,464 |
Balance (in shares) at Dec. 31, 2018 | 0 | 95,287,268 | |||||
Accretion of redeemable noncontrolling interest | (1,065) | ||||||
Issuance of common stock and warrants pursuant to financing agreements | $ 0 | $ 1 | 0 | 181 | 0 | 0 | 182 |
Issuance of common stock and warrants pursuant to financing agreements (in shares) | 0 | 58,904 | |||||
Issuance of common stock for options exercised | $ 0 | $ 5 | 0 | 849 | 0 | 0 | 854 |
Issuance of common stock for options exercised (in shares) | 0 | 487,421 | |||||
Repurchase of stock options to satisfy tax withholding obligations | $ 0 | $ 0 | 0 | 367 | 0 | 0 | 367 |
Issuance of common stock from exercise of warrants | $ 0 | $ 19 | 0 | 3,256 | 0 | 0 | 3,275 |
Issuance of common stock from exercise of warrants (in shares) | 0 | 1,938,105 | |||||
Stock issuance costs | $ 0 | $ 0 | 0 | (190) | 0 | 0 | (190) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 0 | 7,310 | 0 | 0 | 7,310 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 1,501 | 0 | 1,501 |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | 0 | (1,065) | 0 | (44,967) | (46,032) |
Balance at Dec. 31, 2019 | $ 0 | $ 979 | $ (8,034) | $ 606,686 | $ (2,728) | $ (523,908) | $ 72,995 |
Balance (in shares) at Dec. 31, 2019 | 0 | 97,771,698 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (45,362) | $ (27,471) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization for property and equipment | 603 | 366 |
Net loss on disposal of property and equipment | 2 | 5 |
Amortization of intangible assets | 1,550 | 1,305 |
Write down of obsolete inventories | 152 | 0 |
Loss on disposal of intangible assets | 408 | 0 |
Impairment of equipment | 386 | 0 |
Stock-based compensation expense | 7,310 | 6,119 |
Acquired in-process research and development | 6,967 | 553 |
Change in fair value of investment in equity securities | 288 | 320 |
Non-cash interest | 1 | 1 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,293) | 0 |
Inventories | (4,411) | (283) |
Prepaid expenses and other assets | 5,751 | (6,944) |
Right of use assets | 424 | 0 |
Accounts payable | 4,001 | (1,097) |
Payable to related party | 153 | (2,228) |
Accrued liabilities and other liabilities | (173) | 770 |
Net cash used in operating activities | (23,243) | (28,584) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from disposal of property and equipment | 0 | 1 |
Purchases of property and equipment and intangible assets | (427) | (1,131) |
Purchase of land use rights | (6,626) | 0 |
Cash paid to acquired in-process research and development | (6,967) | 0 |
Cash paid to acquire equity securities in Black Belt Tx Limited | (2,250) | 0 |
Cash paid to acquire equity securities in Juventas Cell Therapy Ltd | (11,788) | 0 |
Acquisition of Abbreviated New Drug Applications and related items | 0 | (20,643) |
Net cash used in investing activities | (28,058) | (21,773) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Repayment of notes payable | (1,500) | 0 |
Stock issuance costs | (190) | (822) |
Proceeds from sale of common stock and warrants | 182 | 87,990 |
Cash contribution from redeemable noncontrolling interest | 20,000 | 0 |
Proceeds from exercise of stock options | 854 | 258 |
Repurchase of stock options to satisfy tax withholding obligations | (367) | (117) |
Proceeds from exercise of warrants | 3,275 | 4,961 |
Payment of deferred offfering costs | (209) | 0 |
Net cash provided by financing activities | 22,045 | 92,270 |
Effect of exchange rate change on cash and cash equivalents | (1,328) | (1,198) |
Net increase (decrease) in cash and cash equivalents | (30,584) | 40,715 |
Cash and cash equivalents at beginning of year | 84,205 | 43,490 |
Cash and cash equivalents at end of year | 53,621 | 84,205 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 30 | 0 |
Income taxes paid | $ 0 | $ 0 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2019 | |
DESCRIPTION OF BUSINESS | |
DESCRIPTION OF BUSINESS | 1. DESCRIPTION OF BUSINESS CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets. In August 2019, the Company launched its first commercial product, EVOMELA ® (Melphalan for Injection), in China that is approved for use as a conditioning treatment prior to stem cell transplantation in the multiple myeloma setting. The Company’s other core hematology/oncology assets in its pipeline include (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed as a treatment for patients with B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma; and (iii) greater China rights to ZEVALIN ® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody, that is approved in the U.S. to treat patients with NHL. The Company’s oncology assets also include China rights to (i) octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly, and (ii) a novel formulation of thiotepa, which has multiple indications and a long history of established use in the hematology/oncology setting, both of which are being developed for import registration and market approval in China. The Company has established and continues to expand its operational expertise and execution capability as it further enhances its product and pipeline portfolio. The Company’s EVOMELA, ZEVALIN and MARQIBO ® assets were originally licensed from Spectrum Pharmaceuticals, Inc. (“Spectrum”) and the Company had supply agreements with Spectrum to support the Company’s application for import drug registration and for commercialization purposes. On March 1, 2019, Spectrum completed the sale of its portfolio of FDA-approved hematology/oncology products including EVOMELA, ZEVALIN and MARQIBO to Acrotech Biopharma L.L.C. (“Acrotech”). The original supply agreements with Spectrum were assumed by Acrotech; Spectrum agreed to continue with a short-term supply agreement for EVOMELA for the initial commercial product supply in connection with the Company’s launch, with the long-term supply assumed by Acrotech. As part of the strategy to support our future clinical and commercial manufacturing needs and to manage our supply chain for certain products, on December 26, 2018, we established CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”) to develop a future manufacturing facility in China to be located in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The site is currently in the design and engineering phase. Certain line items in the 2018 consolidated balance sheet and consolidated statement of cash flows relating to inventories have been reclassified to conform to the December 31, 2019 presentation. Inventories in the amount of $283,000 as of December 31, 2018, which was previously included in prepaid expenses and other, has been separately presented on the consolidated balance sheet as of December 31, 2018. Liquidity Risks and Management’s Plans Since its inception in 1991, the Company has incurred significant losses from operations and, as of December 31, 2019, has incurred an accumulated deficit of $523.9 million. In 2012, the Company shifted its business strategy to China and has since built an infrastructure in China that includes sales and marketing, medical affairs, and regulatory and clinical development. In 2014, the Company changed its name to “CASI Pharmaceuticals, Inc.” The majority of the Company’s operations are now located in China. The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities. The Company’s operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd. (“CASI China”), which is located in Beijing, China. Through CASI China, the Company will focus on the China market devoting more resources and investment going forward. Taking into consideration the cash and cash equivalents balance as of December 31, 2019, the Company believes that it has sufficient resources to fund its operations at least through March 16, 2021. As of December 31, 2019, approximately $2.6 million of the Company’s cash balance was held by CASI China, and approximately $22.1 million of the Company’s cash balance was held by CASI Wuxi. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements. New License and Investment Agreements 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 the CID-103, an investigational anti-CD38 monoclonal antibody (Mab) (formerly known as TSK011010). CID-103 is at the IND/IMPD submission stage of development, with a Phase 1 study targeted to start in the United Kingdom during 2020. CASI is responsible for all development and commercialization activities of the CID-103 program. Under the terms of the agreement, CASI obtained global rights to CID-103 for an upfront payment of 5 million euros ($5,657,500) as well as certain milestone and royalty payments. Because CID-103 underlying the acquired rights has not reached technological feasibility and has no alternative uses, the Company expensed 5 million euros as acquired in-process research and development in the accompanying consolidated statement of operations and comprehensive loss for the year ended December 31, 2019. The Company also invested 2 million euros ($2,249,600), representing 15% shareholding, as an equity investment in Black Belt TX Ltd, a newly established company of Black Belt focusing on novel immuno-oncology targets (see Note 5). Juventas Cell Therapy: In June 2019, the Company entered into a license agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. (“Juventas”). Juventas is a China-based domestic company engaged in cell therapy. Juventas will continue to be responsible for the clinical development and regulatory submission and maintenance of CNCT19 regulatory applications, with CASI’s participation on the joint steering committee. CASI will be responsible for the launch and commercialization of CNCT19 and for the payment of certain future development milestones and sales royalties. CNCT19 was engineered from the CD19 CAR-T, and is used to treat cancer patients with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). The China National Medical Products Administration (NMPA) has approved the clinical trial applications for CNCT19 in Phase 1 studies in B-NHL and B-ALL. Juventas is making preparations for the trials and the Company expects that the dosing of the first patient will occur during 2020. All contingent payments will be recognized when the subsequent milestones are probable to be met (see Note 20). CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”) also invested RMB 80 million (approximately $11.8 million), representing 16.3% shareholding, as an equity investment in Juventas (see Note 5). Pharmathen Global BV: On October 29, 2019, the Company entered into an exclusive distribution agreement with Pharmathen Global BV (“Pharmathen”) for the development and distribution of octreotide long acting injectable (Octreotide LAI) microsphere in China. Octreotide LAI formulations are considered a standard of care for the treatment of acromegaly and for the control of symptoms associated with certain neuroendocrine tumors. Octreotide LAI has been approved in various European countries. CASI intends to advance the development, import drug registration, and market approval of this product in China. The Company expects the clinical development program to begin during 2020. The terms of the agreement include an upfront payment of 1 million euros, paid in 2019, and up to 2 million euros of additional milestone payments. 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. Sales of EVOMELA In December 2018, CASI received NMPA approval of EVOLEMA for the use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. In March 2019, CASI entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd. (“CRGK” or the “distributor”), pursuant to which it is the sole customer and distributor for the sale of EVOMELA in China. Commercial sales of EVOMELA were launched in August 2019. For the year ended December 31, 2019, the Company recognized $4.1 million of revenues from sales of EVOMELA under this arrangement. |
ACQUISITION OF ABBREVIATED NEW
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ | 12 Months Ended |
Dec. 31, 2019 | |
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ | |
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ | 3. ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ On January 26, 2018, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Sandoz. Pursuant to the Asset Purchase Agreement, the Company acquired a portfolio of 29 ANDAs, including 25 ANDAs approved by the FDA and four pipeline ANDAs that are pending FDA approval, limited quantities of certain active pharmaceutical ingredient (“API”), and certain manufacturing and other information related to the products (collectively, the ANDAs, API and other information are referred to as the “Acquired Assets”). To facilitate the sale and transition, the parties also entered into several limited term ancillary arrangements. The Acquired Assets enhance the Company’s strategic focus to build a robust pipeline and commercialize quality drug candidates in China. The Company intends to select and commercialize certain products from the portfolio that have unique market and cost-effective manufacturing opportunities. The total purchase price for the Acquired Assets was $18.0 million in cash. The Company accounted for the purchase of the Acquired Assets as an asset acquisition (consisting of a concentrated group of similar identifiable assets, including ANDAs and API). The total purchase price, along with approximately $1.2 million of transaction expenses, was allocated to the Acquired Assets based on their relative estimated fair values, as follows: ANDAs $ 18,608,000 API 564,000 Total value $ 19,172,000 Of the total value allocated to the ANDAs, approximately $553,000 was immediately expensed as acquired in-process research and development since the 4 underlying ANDAs have not been approved by the FDA upon acquisition. Of the total value allocated to the API, approximately $134,000 was immediately expensed as acquired in-process research and development since the Company does not intend to use all of the API. The allocated cost of the capitalized ANDAs will be amortized over their estimated useful lives of 13 years. The capitalized API will be expensed in the period it is used or if its value is otherwise impaired. The fair values of certain acquired ANDAs were estimated using the discounted cash flow method (an income approach). |
ACQUISITION OF ABBREVIATED NE_2
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS | 12 Months Ended |
Dec. 31, 2019 | |
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS | |
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS | 4. ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS In October 2018, the Company entered into an agreement with Laurus, pursuant to which the Company acquired from Laurus one U.S. FDA-approved ANDAs for TDF, which is indicated for the treatment of hepatitis B virus. The total purchase consideration was $3.0 million. In October 2018, the Company made an initial payment of $700,000, and in December 2018, CASI paid $1.3 million as the second milestone was achieved. The Company accounted for the purchase of the TDF ANDA as an asset acquisition and recognized both payments to Laurus, along with $35,121 of transaction expenses, as the cost of the acquired intangible asset. The remaining $1.0 million of contingent consideration will be recorded as an increase to the intangible asset when the subsequent milestones are probable to be met. The Company is amortizing the acquired intangible asset over its estimated useful life of 13 years; any subsequent increase in asset cost as a result of recognizing the contingent consideration will be expensed on a straight-line basis over the asset’s remaining life. |
INVESTMENT IN EQUITY SECURITIES
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS | 12 Months Ended |
Dec. 31, 2019 | |
INVESTMENT IN EQUITY SECURITIES | |
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS | 5. INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS The Company has an equity investment in the common stock of publicly traded company. Beginning on January 1, 2018 with the adoption of ASU 2016‑01, the Company’s investment in this equity security is considered a trading security and is carried at its estimated fair value, with changes in fair value reported in the statement of operations each reporting period. The fair value of this security was measured using its quoted market price, a Level 1 input, and was approximately $0.6 million as of December 31,2019 and $0.9 million on December 31, 2018 (see Note 17). The following table summarizes the Company’s investment as of December 31, 2019: Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains value Common stock Investment $ — $ 625 $ 625 Unrealized losses on the Company’s equity investment for the year ended December 31, 2019 and 2018 were $288,000 and $320,000, respectively, and are recognized as change in fair value of investment in equity securities in the accompanying consolidated statements of operations and comprehensive loss. In April 2019, in conjunction with its license agreement entered into with Black Belt, the Company made a 2 million euro ($2,249,600) equity investment in a newly established, privately held UK Company (see Note 1). In June 2019, in conjunction with its license agreement entered into with Juventas, the Company, through its China subsidiary, made a RMB 80 million ($11,788,000) equity investment in Juventas, a privately held, China-based company (see Note 1). As the Company does not have significant influence over operating and financial policies of Black Belt TX Ltd and Juventas, and the equity interests do not have readily determinable fair value, the investments in Black Belt TX Ltd and Juventas are stated at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment. The Company did not record any adjustments or impairments during the year ended December 31, 2019. |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2019 | |
INVENTORIES | |
INVENTORIES | 6. INVENTORIES Inventories at December 31, 2019 and 2018 consisted of the following: December 31 (In thousands) 2019 2018 Finished goods $ 4,514 $ — Raw materials 28 283 Total $ 4,542 $ 283 Provisions to write-down the carrying amount of obsolete inventory related to ANDAs that were disposed to its estimated net realizable value amounted to $152,000 and $0 for the years ended December 31, 2019 and 2018, respectively, and were recorded as expenses in the consolidated statements of comprehensive loss. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2019 | |
LEASES | |
LEASES | 7. LEASES As discussed in Note 2, effective January 1, 2019, the Company adopted Topic 842. At the inception of a contract, the Company determines if the arrangement is, or contains, a lease. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. 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. The Company has made accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of its operating leases. Operating lease ROU assets are included in other assets (noncurrent) and operating lease liabilities (see below) are included in accrued liabilities and other liabilities (noncurrent) in the consolidated balance sheets as of December 31, 2019. As of December 31, 2019, the Company did not have any finance leases. All of the Company’s existing leases as of December 31, 2019 are classified as operating leases. As of December 31, 2019, the Company has five material operating leases for land, facilities and office equipment with remaining terms expiring from 2021 through 2069 and a weighted average remaining lease term of 49.16 years. The Company has fair value renewal options for three 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 5.16%. 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 is currently in the design and engineering phase for the facility and assessing the construction plan and timeline. The Company classifies this lease as an operating lease. The Company prepaid all of the lease payments for the land use right in 2019 in the amount of RMB45 million (equivalent to US$6.6 million). Rent expense for the year ended December 31, 2019 was approximately $1,315,000. There was no variable lease costs or sublease income for leased assets for the year ended December 31, 2019. The impact of Topic 842 on the December 31, 2019 consolidated balance sheet was as follows: (In thousands) December 31, 2019 Right of use assets $ 8,708 Accrued liabilities 1,182 Other liabilities 1,019 Total lease liabilities $ 2,201 Supplemental cash flow information related to leases was as follows: Year ended (In thousands) December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,315 Right of use assets obtained in exchange for lease obligations: $ 2,157 A maturity analysis of our operating leases as of December 31, 2019 follows: Future undiscounted cash flows: (In thousands) 2020 1,403 2021 892 2022 191 Thereafter — Total 2,486 Discount factor (285) Lease liability 2,201 Amounts due within 12 months 1,182 Non-current lease liability $ 1,019 As previously disclosed in the consolidated financial statements for the year ended December 31, 2018 and under the previous lease standard (Topic 840), future minimum annual lease payments for the years subsequent to December 31, 2018 and in aggregate are as follows: (In thousands) 2019 $ 1,312 2020 1,297 2021 857 2022 130 Thereafter — Total minimum payments $ 3,596 Rental expense for the year ended December 31, 2018 was approximately $916,000. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 8. PROPERTY AND EQUIPMENT Furniture and equipment are stated at cost and are depreciated over their estimated useful lives of 3 to 5 years. Leasehold improvements are stated at cost and are amortized over the shorter of their useful lives or the lease term. Depreciation and amortization expense are determined on a straight-line basis. Depreciation and amortization expense were $603,000 and $366,000 in 2019 and 2018, respectively. Property and equipment consist of the following: (In thousands) December 31, 2019 2018 Furniture and equipment $ 1,305 $ 1,698 Leasehold improvements 792 739 Total property, plant and equipment, gross 2,097 2,437 Accumulated depreciation and amortization (726) (686) Impairment of property, plant and equipment (386) — $ 985 $ 1,751 The Company recognized impairment of approximately $386,000 during the year ended December 31, 2019 related to equipment which was leased to a related party (see Note 18). |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2019 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | 9. INTANGIBLE ASSETS Intangible assets include ANDAs that were acquired as part of 2018 asset acquisitions and US marketed generic products and capitalized cost 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. The ANDAs are amortized over their estimated useful lives of 13 years, using the straight-line method. The cloud computing arrangement is amortized over its useful life of 5 years. For the year ended December 31, 2019 and 2018 there were no intangible asset impairments. Intangible assets at December 31, 2019 consists of the following: (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 18,002 $ (3,122) 13 years TDF ANDA 2,035 (185) 13 years Others 210 (45) 5 years Total $ 20,247 $ (3,352) The changes in intangible assets for the year ended December 31, 2019 are as follows: (In thousands) Balance as of December 31, 2018 $ 18,785 Additions 192 Disposal (408) Amortization expense (1,550) Foreign currency translation adjustment (124) Balance as of December 31, 2019 $ 16,895 Expected future amortization expense is as follows as of December 31, 2019: (In thousands) 2020 $ 1,540 2021 1,540 2022 1,540 2023 1,540 2024 1,499 2025 and thereafter 9,236 |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2019 | |
NOTE PAYABLE | |
NOTE PAYABLE | 10 . NOTE PAYABLE As part of the license arrangements with Spectrum (see Note 18), the Company issued to Spectrum a $1.5 million 0.5% secured promissory note originally due March 17, 2016, which was subsequently amended and extended to September 17, 2019. The promissory note was recorded initially at its fair value, giving rise to a discount of approximately $136,000; the promissory note is presented as note payable, net of discount in the accompanying Consolidated Balance Sheet as of December 31, 2018. For the years ended December 31, 2019 and 2018, the Company recognized $5,600 and $7,500 of interest expense related to the promissory note, respectively. The note payable was paid off in September 2019 before the due date. |
REDEEMABLE NONCONTROLLING INTER
REDEEMABLE NONCONTROLLING INTEREST | 12 Months Ended |
Dec. 31, 2019 | |
REDEEMABLE NONCONTROLLING INTEREST | |
REDEEMABLE NONCONTROLLING INTEREST | 11. REDEEMABLE NONCONTROLLING INTEREST On December 26, 2018, the Company, together with Wuxi Jintou Huicun Investment Enterprise, a limited partnership organized under Chinese law (“Wuxi LP”) established CASI Wuxi to build and operate a manufacturing facility in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The Company holds 80% of the equity interests in CASI Wuxi and will invest, over time, $80 million in CASI Wuxi. The Company’s investment will consist of (i) $21 million in cash (paid in February 2019), (ii) a transfer of selected ANDAs valued at $30 million (transferred in May 2019), and (iii) an additional $29 million cash payment within three years from the date of establishment of CASI Wuxi. Wuxi LP holds 20% of the equity interest in CASI Wuxi through its investment in RMB of $20 million in cash (paid in March 2019). As the transfer of ANDAs valued at $30 million was to the Company’s consolidated subsidiary (CASI Wuxi), the Company recognized the transfer of the ANDAs at their carrying value and did not recognize a gain on the transfer. Pursuant to the investment contract between the Company and Wuxi LP and Articles of Association of CASI Wuxi, the Company has the call option to purchase the 20% equity interest in CASI Wuxi held by Wuxi LP at any time within 5 years from the date of establishment of CASI Wuxi (i.e. up to December 26, 2023). Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at any time after December 26, 2023. The redemption value under both the Company’s embedded put option and Wuxi LP’s embedded call option is equal to $20 million plus interest at the bank loan interest rate issued by the People's Bank of China for the period beginning with the initial capital contribution by Wuxi LP to the date of redemption. In addition, Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at $20 million upon the occurrence of any of the following conditions: (i) the Company fails to fulfill its investment obligation to CASI Wuxi; (ii) CASI Wuxi suffers serious losses, discontinued operation, dissolution, goes into process of bankruptcy liquidation; or (iii) the Company substantially violates the investment contract and Articles of Association of CASI Wuxi. The investment of Wuxi LP in CASI Wuxi is treated as redeemable noncontrolling interest and is classified outside of permanent equity on the consolidated balance sheets because (1) the noncontrolling interest is not mandatorily redeemable financial instruments, and (2) it is redeemable at the option of the holder, or upon the occurrence of an event that is not solely within the control of the Company. The Company initially recorded the redeemable noncontrolling interest at its fair value of $20 million. The carrying amount of the redeemable noncontrolling interest is subsequently recorded at the greater of the amount of (1) the initial carrying amount, increased or decreased for the redeemable noncontrolling interest’s share of net income or loss in CASI Wuxi or (2) the redemption value, assuming the noncontrolling interest is redeemable at the balance sheet date. Accretion of the carrying amount of redeemable noncontrolling interest to the redemption value is recorded in additional paid-in capital. Changes in redeemable noncontrolling interest during the year ended December 31, 2019 are as follows: (In thousands) Balance as of December 31, 2018 $ — Cash contribution by Wuxi LP 20,000 Share of CASI Wuxi net loss (395) Accretion of redeemable noncontrolling interest 1,065 Balance as of December 31, 2019 $ 20,670 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2019 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 12. STOCKHOLDER’S EQUITY The Company had 250 million and 170 million of authorized common stock at December 31, 2019 and 2018, respectively. The Company had 5 million of authorized preferred stock as December 31, 2019 and 2018. The Company held 79,545 of shares of common stock in treasury at its acquisition cost at December 31, 2019 and 2018. Common Stock Sales Agreements On February 23, 2018, the Company entered into a Common Stock Sales Agreement (the "Sales Agreement") with H.C. Wainwright & Co., LLC ("HCW"). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company's common stock, through HCW, as sales agent. On July 19, 2019, the Company entered into an amendment to the Sales Agreement reducing the maximum amount that may be sold under the Sales Agreement to $20 million. In 2018, the Company issued 143,248 shares under the Sales Agreement resulting in net proceeds to the Company of approximately $475,000. As of December 31, 2019, approximately $19.5 million remained available under the Sales Agreement. On July 19, 2019, the Company entered into an Open Market Sale AgreementSM with Jefferies LLC (the "Open Market Agreement"). Pursuant to the terms of the Open Market Agreement, the Company may elect to sell from time to time, at its option, up to $30 million in shares of the Company's common stock, through Jefferies LLC, as sales agent. Any sales of shares pursuant to the Open Market Agreement will be made under the Company's Registration Statement and the related prospectus supplement and the accompanying prospectus, as filed with the SEC on July 19, 2019. In 2019, the Company issued 58,904 shares under the Open Market Agreement resulting in net proceeds to the Company of approximately $182,000. At December 31, 2019, approximately $29.8 million remained available under the Open Market Agreement. Subsequent to December 31, 2019 and through March 16, 2020, the Company issued 434,336 shares under the Open Market Agreement, resulting in net proceeds to the Company of approximately $1,357,000. Securities Purchase Agreements In September 2018, the Company entered into securities purchase agreements with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company agreed to sell up to 9,048,504 shares of its common stock with accompanying warrants to purchase 2,714,548 shares of its common stock in a $48.5 million private placement ("September 2018 Offering"). The purchase price for each share of common stock and warrant was $5.36. The warrants are exercisable on March 23, 2019 at a $7.19 per share exercise price and expire on September 24, 2021. In 2018, the Company issued a total of 6,996,266 shares of its common stock with accompanying warrants to purchase 2,098,877 shares of its common stock and received $37.5 million in gross proceeds. The Company does not expect to receive any further proceeds from the September 2018 Offering. The estimated fair value of the equity-classified warrants issued is $6,254,653 or $2.98 per warrant, calculated using the Black-Scholes-Merton valuation model with a contractual life of 3 years, an assumed volatility of 88.39%, and a risk-free interest rate of 2.89%. In March 2018, the Company entered into securities purchase agreements with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company issued 15,432,091 shares of its common stock with accompanying warrants to purchase 6,172,832 shares of its common stock and received $50 million in gross proceeds in a private placement. The purchase price for each share of common stock and warrant was $3.24. The warrants became exercisable on September 17, 2018 at a $3.69 per share exercise price and will expire on March 21, 2023. The estimated fair value of the equity-classified warrants issued is $15,062,000, or $2.44 per warrant, calculated using the Black-Scholes-Merton valuation model with a contractual life of 5 years, an assumed volatility of 75.4%, and a risk-free interest rate of 2.69%. Stock purchase warrants activity for the year ended December 31, 2019 and 2018 is as follows: Number of Weighted Average Warrants Exercise Price Outstanding at December 31, 2017 6,264,016 $ 2.23 Issued 8,271,709 $ 4.58 Exercised (2,753,900) $ 1.80 Expired — $ — Outstanding at December 31, 2018 11,781,825 $ 3.98 Issued — $ — Exercised (1,938,105) $ 1.69 Expired — $ — Outstanding at December 31, 2019 9,843,720 $ 4.43 Exercisable at December 31, 2019 9,843,720 $ 4.43 All outstanding warrants are equity classified. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2019 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 13. NET LOSS PER SHARE Net loss per share (basic and diluted) was computed by dividing net loss attributable to common stockholders, considering the accretions to redemption value of the redeemable noncontrolling interest, by the weighted average number of shares of common stock outstanding. Outstanding stock options and warrants totaling 28,112,092 and 30,211,133 as of December 31, 2019 and 2018, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. The following table sets forth the basic and diluted net loss per share computation and provides a reconciliation of the numerator and denominator for the periods presented: (In thousands, except per share data) Year Ended December 31, 2019 2018 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (46,032) $ (27,471) Denominator: Weighted average number of common shares 95,948 84,752 Denominator for basic and diluted net loss per share calculation 95,948 84,752 Net loss per share — Basic and diluted $ (0.48) $ (0.32) |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2019 | |
EMPLOYEE BENEFIT PLAN | |
EMPLOYEE BENEFIT PLAN | 14. EMPLOYEE BENEFIT PLAN The Company sponsors the CASI Pharmaceuticals, Inc. 401(k) Plan and Trust. The plan covers substantially all U.S. employees and enables participants to contribute a portion of salary and wages on a tax-deferred basis. Contributions to the plan by the Company are discretionary. Contributions by the Company totaled $217,000 and $151,000 in 2019 and 2018, respectively. Full time employees of the Company in the PRC participate in a government mandated defined contribution plan, pursuant to which certain pension benefits, medical care, employee housing fund and other welfare benefits are provided to employees. Chinese labor regulations require that the PRC subsidiaries of the Company make contributions to the government for these benefits based on certain percentages of the employees' salaries. The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were approximately $1,780,000 and $724,000 for the years ended December 31, 2019 and 2018, respectively. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2019 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 15. STOCK-BASED COMPENSATION The Company has adopted various stock compensation plans for executive, scientific and administrative personnel of the Company, as well as outside directors and consultants. In June 2019, the Company’s stockholders approved an amendment to the 2011 Long-Term Incentive Plan, increasing the number of shares of common stock reserved for issuance from 20,230,000 to 25,230,000 to be available for grants and awards. As of December 31, 2019, a total of 11,389,078 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan. The Company’s net loss for the twelve months ended December 31, 2019 and 2018 includes $7,310,000 and $6,119,000, respectively, of non-cash compensation expense related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows: Year ended December, (In thousands) 2019 2018 Research and development $ 466 $ 741 General and administrative 6,844 5,378 Share-based compensation expense $ 7,310 $ 6,119 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 years ended December 31, 2019 and 2018, approximately $73,000 and $644,000 was expensed for share awards with performance conditions that became probable during the year, respectively. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of service based and performance-based stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. Expected Volatility —Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. The Company uses the historical volatility based on the daily price observations of its common stock during the period immediately preceding the share-based award grant that is equal in length to the award’s expected term. The Company believes that historical volatility represents the best estimate of future long term volatility. Risk -Free Interest Rate —This is the average interest rate consistent with the yield available on a U.S. Treasury note (with a term equal to the expected term of the underlying grants) at the date the option was granted. Expected Term of Options —This is the period of time that the options granted are expected to remain outstanding. The Company uses a simplified method for estimating the expected term of service based awards granted. For performance based awards, the expected term of service is based on the derived service period. Expected Dividend Yield —The Company has never declared or paid dividends on its common stock and does not anticipate paying any dividends in the foreseeable future. As such, the dividend yield percentage is assumed to be zero. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the years ended December 31, 2019 and 2018: Year ended December 31, 2019 2018 Expected volatility 77.30 % 78.78 % Risk free interest rate 1.87 % 2.80 % Expected term of option 6.05 years 5.77 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the years ended December 31, 2019 and 2018 were $2.20 and $4.49, respectively. A summary of the Company’s stock option plans and changes in options outstanding under the plans during the years ended December 31, 2019 and 2018 is as follows: Weighted Average Weighted Average Remaining Number of Options Exercise Price Contractual Term In Years Aggregate Intrinsic Value Outstanding at December 31, 2017 11,585,315 $ 1.42 Exercised (156,283) $ 1.65 $ 643,000 Granted 7,336,000 $ 4.01 Expired (285,594) $ 1.55 Forfeited (50,130) $ 3.28 Outstanding at December 31, 2018 18,429,308 $ 2.44 Exercised (599,002) $ 1.43 $ 1,124,000 Granted 5,834,808 $ 3.01 Expired (7,090) $ 3.69 Forfeited (1,389,652) $ 1.17 Cancelled (4,000,000) $ 3.22 Outstanding at December 31, 2019 18,268,372 $ 2.58 6.30 $ 16,414,546 Vested and expected to vest at December 31, 2019 18,018,372 $ 2.57 6.38 $ 16,414,546 Exercisable at December 31, 2019 11,192,819 $ 1.99 4.52 $ 15,311,057 The aggregate intrinsic value is calculated as the difference between (i) the closing price of the common stock at December 31, 2019 and (ii) the exercise price of the underlying awards, multiplied by the number of options that had an exercise price less than the closing price on the last trading day of the year. Cash received from option exercises under all share-based payment arrangements for the twelve months ended December 31, 2019 and 2018 was $854,000 and $258,000, respectively. In March 2018, the Compensation Committee of the Board of Directors (the “Board”) approved a grant of stock options to the Company’s Executive Chairman exercisable for 1.0 million shares of common stock that will vest and become exercisable on the first anniversary date of the grant. In addition, the Board approved the grant of a performance-based option covering 4.0 million shares of common stock that will vest if, within 18 months of the date of grant, specific operational and strategic milestones are achieved. In April 2019, the 2018 performance-based option awarded to the Company's Chairman and CEO, covering 4 million shares of common stock was cancelled. At the date of cancellation, the performance condition of the option award was not expected to vest based on the original vesting conditions, and therefore no compensation cost was recognized on the cancellation date. On June 20, 2019, the Company's stockholders approved a grant of stock options to the Company’s Chairman and CEO at the 2019 Annual Meeting. Under the terms of the grant, the Company's Chairman and CEO received a stock option covering 4 million shares of common stock, at an exercise price of $2.85, vesting upon the earlier of (i) the completion of a transformative event by the Company as determined at the discretion of the Company's compensation committee and (ii) April 2, 2021, the second anniversary of the date of his appointment as CEO. The following summarizes information about stock options that are outstanding at December 31, 2019: Options Outstanding Options Exercisable Weighted Average Weighted Weighted Number Remaining Average Number Average Range of Outstanding at Contractual Exercise Exercisable at Exercise Exercise Prices December 31, 2019 Life in Years Price December 31, 2019 Price $0.00 - $1.00 2,193,853 3.70 $ 0.91 2,193,853 $ 0.91 $1.01 - $2.00 6,682,402 3.84 $ 1.52 6,605,614 $ 1.53 $2.01 - $4.00 7,511,301 8.81 $ 3.04 1,656,495 $ 3.11 $4.01 - $7.00 1,639,000 8.11 $ 6.25 495,041 $ 6.28 $7.01 - $9.00 241,816 7.22 $ 8.10 241,816 $ 8.10 18,268,372 6.30 $ 2.58 11,192,819 $ 1.99 As of December 31, 2019, there was approximately $13,639,000 of total unrecognized compensation cost related to non-vested stock options, excluding not-probable performance condition options. That cost is expected to be recognized over a weighted-average period of 2.2 years. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES | |
INCOME TAXES | 16. INCOME TAXES For financial reporting purposes, loss before income taxes includes the following components: (In thousands) 2019 2018 United States $ (28,957) $ (19,820) Foreign (16,405) (7,651) Total $ (45,362) $ (27,471) Significant components of the Company’s deferred income tax assets and liabilities as of December 31, 2019 and 2018 are as follows: December 31, (In thousands) 2019 2018 Deferred income tax assets: Net operating loss carryforwards $ 94,828 $ 97,701 Research and development credit carryforward 7,740 8,957 Intangible assets 5,733 4,378 Equity-based compensation 5,423 4,075 Other 396 81 Valuation allowance for deferred income tax assets (114,120) (115,192) Net deferred income tax assets $ — $ — The Company has U.S. federal and state net operating loss (NOL) carryforwards of approximately $356,300,000 at December 31, 2019. The Company also has People’s Republic of China (“PRC”) NOL carryforwards of approximately $25,000,000 at December 31, 2019. The Company's U.S. federal NOL carryforwards generated prior to 2018 begin to expire in 2020. The Company also has research and experimentation (“R&E”) tax credit carryforwards of approximately $7,740,000 as of December 31, 2019 that begin to expire in 2020. Under the provisions of the Internal Revenue Code, the NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. For financial reporting purposes, a 100% valuation allowance has been recognized to reduce the net deferred tax assets to zero because it is more likely than not that the Company could not generate sufficient taxable income in the future to realize the benefit of deferred income tax assets. A reconciliation of the provision for income taxes to the federal statutory rate is as follows: (In thousands) 2019 2018 Tax benefit at statutory rate $ (9,526) $ (5,769) State taxes (1,701) (1,098) Attribute expiration 12,461 7,200 Nondeductible expenses 453 29 Other (608) (82) Change in applicable tax rates (7) (934) Change in valuation allowance (1,072) 654 $ — $ — The Company had $2,986,000 of unrecognized tax benefits as of December 31, 2018 related to net R&E tax credit carryforwards. For the year ended December 31, 2019, there was a net reduction of unrecognized tax benefits of $405,000 related to R&E tax credits. The Company has a full valuation allowance at December 31, 2019 and 2018 against the full amount of its net deferred tax assets and, therefore, there was no impact on the Company’s financial position. The Company does not expect significant changes to the unrecognized benefit during 2020. As of December 31, 2019 and 2018, the Company did not accrue any interest related to uncertain tax positions. To date, there have been no interest or penalties charged to the Company related to income taxes. A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: (In thousands) 2019 2018 Unrecognized tax benefits balance at January 1 $ 2,986 $ 3,198 Reductions for tax positions of prior periods (405) (214) Additions for tax positions of current period — 2 Unrecognized tax benefits balance at December 31 $ 2,581 $ 2,986 The Company and each of its PRC subsidiaries file income tax returns in the United States and the PRC, respectively. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), all of the Company’s tax returns since 1999 are open to examination by the taxing authorities. According to the PRC Tax Administration and Collection Law, the statute of limitations is three years if the underpayment of taxes is due to computational errors made by the taxpayer or the withholding agent. The statute of limitations is extended to five years under special circumstances where the underpayment of taxes is more than RMB100,000 (approximately $14,334). In the case of transfer pricing issues, the statute of limitations is ten years. There is no statute of limitations in the case of tax evasion. The PRC tax returns for the Company’s PRC subsidiaries are open to examination by the PRC tax authorities for the tax years beginning in 2014. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2019 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | 17. FAIR VALUE MEASUREMENTS The majority of the Company’s financial instruments (consisting of cash and cash equivalents, account receivable, accounts payable and accrued liabilities) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities is carried at fair value (see Note 5). The Company also had a note payable which was paid off during the year ended December 31, 2019 (see Note 10). The notes payable was carried at amortized cost which approximates fair value due to its classification as a short-term note payable. 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 an equity investment in the common stock of publicly traded company. The Company’s investment in this equity security is carried at its estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period (see Note 5). The fair value of the common stock is based on quoted market price for the investee’s common stock, a Level 1 input. The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of December 31, 2019 and December 31, 2018, by level within the fair value hierarchy: (In thousands) Fair Value at December 31, Description 2019 Level 1 Level 2 Level 3 Investment in common stock $ 625 $ 625 $ — $ — Fair Value at December 31, Description 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912 $ 912 $ — $ — Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company has no financial assets and liabilities that are measured at fair value on a non- recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis Fair Value at December Description 31, 2019 Level 1 Level 2 Level 3 Long-lived assets $ 287 $ — $ — $ 287 The long-lived assets represent equipment leased to Juventas (Note 18). As of December 31, 2019, equipment leased to Juventas with a total carrying amount of $673,000 were written down to their fair value of $287,000, resulting in an impairment charge of $386,000, representing the difference between total carrying amount and fair value of these long-lived assets, which was calculated based on Level 3 Inputs. No impairment was recorded for the year ended December 31, 2018. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2019 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | 18. RELATED PARTY TRANSACTIONS In June 2019, CASI Pharmaceuticals, Inc. entered into a license agreement for exclusive worldwide license and commercialization rights to CNCT19 from Juventas (see Note 1). Transactions with Juventas are considered to be related party transactions as the Company’s CEO and Chairman is the chairman and one of the founding shareholders of Juventas. A committee of independent directors of CASI negotiated the terms of the investment and license agreements and recommended that the board of directors approve the transaction. The Company’s CEO did not participate in the committee’s deliberations or the board of directors’ approval of the transaction. On July 1, 2019 the Company entered into a one-year equipment lease with Juventas in the amount of RMB80,000 (approximately $15,000) a month, which is classified as an operating lease. During the year ended December 31, 2019, the Company recognized lease income of $68,000 and expects to recognize approximately $69,000 of additional lease income in 2020 related to this lease. The lease can be extended after one year. There were no other material transactions with Juventas during the year ended December 31, 2019. The Company had certain product rights and perpetual exclusive licenses from Spectrum Pharmaceuticals, Inc. (“Spectrum”) to develop and commercialize EVOMELA (Melphalan Hydrochloride For Injection) (“EVOMELA”), ZEVALIN (Ibritumomab Tiuxetan) (“ZEVALIN”) and MARQIBO (Vincristine Sulfate Liposome Injection) (“MARQIBO”) in the greater China region. Spectrum is a greater than a 10% shareholder of the Company. Based on the original licenses, the Company had supply agreements with Spectrum for the purchase of EVOMELA, ZEVALIN, and MARQIBO in China for quality testing purposes to support the Company’s application for import drug registration and for commercialization purposes. On March 1, 2019, Spectrum completed the sale of its portfolio of seven FDA-approved hematology/oncology products including EVOMELA, MARQIBO, and ZEVALIN to Acrotech. The original supply agreements with Spectrum for EVOMELA, MARQIBO, and ZEVALIN were assumed by Acrotech; Spectrum agreed to continue with a short-term supply agreement for EVOMELA for the initial commercial product supply for the greater China region. As part of the license arrangements with Spectrum, the Company issued to Spectrum a secured promissory note originally due March 17, 2016, which was subsequently amended and extended to September 17, 2019. The principal of the secured promissory note is $1.5 million and the coupon interest rate is 0.5%. The Company paid this note, including accrued interest in full during the year ended December 31, 2019. In 2018, the Company entered into commercial purchase obligation commitments for EVOMELA from Spectrum totaling approximately $9.2 million under the short-term supply agreement for EVOMELA. As of December 31, 2019, the Company has paid $7.6 million relating to the manufacturing and purchase of the EVOMELA commercial product supply and the amount due to Spectrum of $0.2 million was reflected in accounts payable in the consolidated financial statements. As of December 31, 2019, $4.5 million was reflected in inventories as the goods have been received and $3.3 million has been included in costs of revenues and as of December 31, 2018, $4.9 million of the advance payments were reflected in prepaid expenses and other in the accompanying consolidated financial statements. The Company also accrued approximately $2.6 million for material costs related to EVOMELA during the year ended December 31, 2019 which are included in accrued expenses. In 2018, Emerging Technology Partners, LLC (“ETP”) incurred approximately $1.5 million of expenses on the Company’s behalf for due diligence and related services (the “Services”) for certain business development activities. The Company’s Chief Executive Officer and Chairman is the founder and managing member of ETP. The expenses incurred in connection with the Services is included as general and administrative expenses in the accompanying consolidated statement of operations for the year ended December 31, 2018; the amount was paid in October 2018. The Company’s Chief Executive Officer and Chairman, and the former Company’s Chief Executive Officer who has resigned in April 2019 played a key role in identifying and securing potential investors for the September 2018 Offering. As a result, the Company did not have to pay a commission to, or incur additional expenses for, a placement agent. In exchange for their services, which were deemed to be outside the scope of their responsibilities as officers and directors of the Company, the Company paid $1,380,000 and $120,000 to the Chief Executive Officer and Chairman and the former Chief Executive Officer, respectively. These payments are included as general and administrative expenses in the accompanying consolidated statement of operations for the year ended December 31, 2018; the amount was paid in October 2018. |
ACROTECH LICENSE ARRANGEMENTS
ACROTECH LICENSE ARRANGEMENTS | 12 Months Ended |
Dec. 31, 2019 | |
ACROTECH LICENSE ARRANGEMENTS | |
ACROTECH LICENSE ARRANGEMENTS | 19. ACROTECH LICENSE ARRANGEMENTS The Company has certain product rights and perpetual exclusive licenses from Acrotech to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”): - Melphalan Hydrochloride For Injection (EVOMELA); - Ibritumomab Tiuxetan (ZEVALIN); and - Vincristine Sulfate Liposome Injection (MARQIBO). CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed. In March 2016, Spectrum, the former owner of EVOMELA, received notification from the U.S. Food and Drug Administration (“FDA”) of the grant of approval of its New Drug Application (NDA) for EVOMELA primarily for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. In December 2016, the NMPA accepted for review the Company’s import drug registration application for EVOMELA and in 2017 granted priority review of the import drug registration clinical trial application (CTA). On December 3, 2018 the Company received NMPA’s approval for importation, marketing and sales in China for EVOMELA. The Company has in place an experienced commercial team with a successful track record to execute the commercial sales of EVOMELA that launched in August 2019. The Company is also preparing for a post-marketing study required as part of the NMPA marketing approval. The Company is in the process of advancing the development of ZEVALIN in China. In 2017, the NMPA accepted for review the Company’s import drug registration for ZEVALIN including both the antibody kit and the radioactive Yttrium-90 component. On February 12, 2019, the Company received NMPA’s approval of the Company’s CTA to conduct a registration trial to evaluate the efficacy and safety of ZEVALIN. The Company intends to advance the development, import drug registration, and market approval of ZEVALIN in China and currently is in the planning/execution stage for the registration study. In 2016, the NMPA accepted for review the Company’s import drug registration application for MARQIBO. In March 2019 the Company received NMPA’s approval of the Company’s MARQIBO CTA to allow for a trial to evaluate its efficacy and safety. The Company is currently evaluating its options in an evolving standard of care environment for the approved rare and niche indication. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2019 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 20. COMMITMENTS AND CONTINGENCIES In 2018, the Company entered into purchase obligation commitments for EVOMELA from Spectrum for approximately $9.2 million (see Note 18). All of these EVOMELA purchase commitments have been delivered as of October 2019. In conjunction with the Black Belt and Juventas agreements entered into during 2019 (see Note 1), the Company is responsible for certain milestone and royalty payments. As of December 31, 2019, no milestones have been achieved. In conjunction with the Pharmathen agreement entered into during 2019 (see Note 1), the Company is responsible for certain milestone payments. As of December 31, 2019, no milestones have been achieved. In conjunction with the Laurus Labs agreement entered into during 2018 (see Note 4), the Company is responsible for certain remaining milestone payments. As of December 31, 2019, the remaining milestones have not been achieved. In November 2019, CASI Wuxi entered into a lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility. Pursuant to the agreement, CASI Wuxi commits to invest land use right and property, plant and equipment of RMB1 billion (equivalent to US$ 143 million) within three years from the date of establishment of CASI Wuxi. The timing of the development and investment plans are subject to further discussion with the government. The Company is currently in the design and engineering phase for the facility and assessing the construction plan and timeline. 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to recoverability of intangible assets and long-term investments, net realizable value and obsolescence allowance for inventory, deferred tax assets and valuation allowance, allowance for doubtful accounts, and stock-based arrangements. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements. |
Consolidation | Consolidation The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries, in which CASI, directly or indirectly, has a controlling financial interest. These subsidiaries include Miikana Therapeutics, Inc. (“Miikana”), CASI China, CASI Wuxi and CASI Biopharmaceuticals. CASI China is a non-stock Chinese entity with 100% of its interest owned by CASI. CASI China received approval for a business license from the Beijing Industry and Commercial Administration in August 2012 and has operating facilities in Beijing. All inter-company balances and transactions have been eliminated in consolidation. |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The accompanying consolidated financial statements of the Company are reported in US dollars. The financial position and results of operations of the Company’s subsidiaries in the PRC are measured using the Renminbi (RMB), which is the local and functional currency of these entities. Assets and liabilities of the Company’s PRC subsidiaries are translated into US$ using the exchange rates in effect at the consolidated balance sheet date. The revenues and expenses of these entities are translated into US$ at the weighted average exchange rates for the period. The resulting translation gains (losses) are recorded in accumulated other comprehensive income (loss) as a component of shareholders’ equity. Transactions denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Net gains or losses resulting from foreign currency denominated transactions are recorded in foreign exchange gain (losses) in the consolidated statements of operations. |
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 we satisfy a performance obligation. The Company recognizes revenue on sales of EVOMELA when the control of the product is transferred to the distributor, which occurs upon delivery of the product to the carrier appointed by the distributor, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product, excluding amounts collected on behalf of third parties (e.g. value-added taxes). Payment terms for these sales are due within 90 days. The arrangement does not include any variable consideration. The costs of assurance type warranties that provide the customer the right to exchange purchased product that does meet appropriate quality standards are recognized when they are probable and are reasonably estimable. There was no product exchange during the year ended December 31, 2019. As of December 31, 2019, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of December 31, 2019. |
Concentrations of Risk | Concentrations of Risk Cash Concentration Risk The Company maintains its U.S. and RMB cash in bank deposit accounts, which, at times, may exceed regulated insured limits. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. Vendor Concentration Risk The Company has a sole supplier for its EVOMELA product. To date, it has been sourced solely from Spectrum and its suppliers, and all future needs will be sourced from Acrotech and its suppliers. The Company’s ability to select other providers of EVOMELA is limited by FDA regulations. Sales Concentration Risk CRGK is the sole customer of the Company’s EVOMELA product sales in China. All revenues for the year ended December 31, 2019 were generated from sales to CRGK in China, and all the Company’s accounts receivable balance as of December 31, 2019 was due from CRGK. The Company extends credit to CRGK on an unsecured basis and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable. In establishing the required allowance, management considers the historical losses, customer’s financial condition, the amount of accounts receivables in dispute, the accounts receivables aging and the customer’s payment pattern. The Company determined that no allowance for doubtful accounts was necessary as of December 31, 2019. The balance of accounts receivable as of December 31, 2019 has been subsequently collected. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The majority of the Company’s financial instruments (consisting principally of cash and cash equivalents, accounts receivable, prepaid expenses, accounts payable, and accrued liabilities) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities is carried at fair value (see Note 5). The Company also had a note payable which was paid off during the year ended December 31, 2019 (see Note 10). The Company’s note payable was carried at amortized cost which approximates fair value due to its classification as a short-term note payable. See Note 17 for additional fair value disclosures. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days that are readily convertible to known amounts of cash. |
Inventories | Inventories Inventories consist of EVOMELA finished goods and raw materials to be used in production of ANDAs and are stated at the lower of cost or net realizable value. Cost is determined using a first-in, first-out method. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Adjustments are recorded to write down the carrying amount of any obsolete and excess inventory to its estimated net realizable value based on historical and forecasted demand. |
Costs of Revenues | Costs of Revenues Costs of revenues consist primarily of the cost of inventories of EVOMELA and sales-based royalties related to the sale of EVOMELA. |
Investment | Investments Investment in equity securities with readily determinable fair value are measured at fair values, and any changes in fair value are recognized in earnings. Where the fair value of an investment in equity securities is not readily determinable, the Company recognizes such investment in long-term investments, and uses the measurement alternative of cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. For equity investments measured at fair value with changes in fair value recorded in earnings, the Company does not assess whether those securities are impaired. For equity investments without readily determinable fair value, at each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. Impairment indicators that the Company considers include, but are not limited to, (i) the deterioration of earnings performance, credit rating, asset quality, or business prospects of the investee, (ii) a significant adverse change in the regulatory, economic, or technological environment of the investee, (iii) a significant adverse change in the general market condition of either the geographic area or the industry in which the investee operates. If a qualitative assessment indicates that the investment is impaired, the Company has to estimate the investment’s fair value and if the fair value is less than the investment’s carrying value, the Company recognizes an impairment loss in non-operating expenses equal to the difference between the carrying value and fair value. Dividend income is recognized in other income when earned. |
Leases | Leases The Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASC 842”) and subsequent amendments issued by FASB on January 1, 2019, using a modified retrospective method for leases that exist at, or are entered into after, January 1, 2019, and has not recast the comparative periods presented in the consolidated financial statements. Prior to the adoption of ASC 842, operating leases were not recognized on the balance sheet of the Company, instead rent expenses with fixed escalating payments and/or rent holidays were recognized on a straight-line basis over the lease term. Upon adoption of ASC 842, ROU assets and lease liabilities are recognized upon lease commencement for operating leases based on the present value of lease payments over the lease term. As the rate implicit in the lease cannot be readily determined, the Company uses incremental borrowing rate at the lease commencement date in determining the imputed interest and present value of lease payments. The incremental borrowing rate was determined based on the rate of interest that the Company would have to borrow an amount equal to the lease payments on a collateralized basis over a similar term. The incremental borrowing rate is primarily influenced by the risk-free interest rate of China and the US, the Company’s credit rating and lease term, and is updated for measurement of new lease liabilities. For operating leases, the Company recognizes a single lease cost on a straight-line basis over the remaining lease term. The Company has elected not to recognize ROU assets or lease liabilities for leases with an initial term of 12 months or less; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. In addition, the Company has elected not to separate non-lease components (e.g., common area maintenance fees) from the lease components. Land use rights acquired are assessed in accordance with ASC 842 and recognized in right-of-use assets if they meet the definition of lease. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, including property and equipment, operating lease right-of-use (“ROU”) assets and intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Such events and circumstances include the use of the asset or asset group in current research and development projects, and any potential alternative uses of the asset or asset group. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. Impairment charges recorded in 2019 were $386,000 related to fixed asset impairments, compared to $0 in 2018. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical testing and clinical trials of the Company’s product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses, along with the amortization of acquired ANDAs. Research and development costs are expensed as incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company records compensation expense associated with service and performance-based stock options in accordance with provisions of authoritative guidance. The estimated fair value of service-based awards is determined using option pricing models that use unobservable inputs and is generally recognized on a straight-line basis over the requisite service period and based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. |
Income Taxes | Income Taxes Income tax expense is recognized using the asset and liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities and operating loss and tax credit carryforwards as measured by the enacted tax rates that will be in effect when these differences reverse. A valuation allowance is provided to reduce the amount of deferred income tax assets if it is considered more likely than not that some portion or all of the deferred income tax assets will not be realized. The Company recognizes in its consolidated financial statements the impact of a tax position if a tax return position or future tax position is “more likely-than-not” to be sustained upon examination, based on the technical merits of the position. Tax positions that meet the “more-likely-than-not” recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. The Company recognizes interest and penalties related to uncertain tax positions, if any, in income tax expense. |
Net Loss Per Share | Net Loss Per Share Net loss per share (basic and diluted) was computed by dividing net loss attributable to common shareholders by the weighted average number of shares of common stock outstanding. Outstanding options and warrants totaling 28,112,092 and 30,211,133 as of December 31, 2019 and 2018, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. |
New Accounting Pronouncements | New Accounting Pronouncements Recently Adopted Pronouncements In January 2016, the FASB issued ASU 2016‑01, Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities . In February 2018, the FASB issued ASU 2018‑03, Technical Corrections and Improvements to Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities. The accounting standards primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. The Company adopted ASU 2016‑01 and ASU 2018‑03 on January 1, 2018 and recorded a cumulative effect adjustment that decreased accumulated deficit by approximately $1.2 million. Effective January 1, 2018, the adoption date, changes in the fair value of the Company’s investments in equity securities are recognized in the consolidated statements of operations and comprehensive loss (see Note 5). Effective January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2016-02, Leases (“Topic 842”). The guidance amends the accounting requirements for leases and requires lessees to recognize assets and liabilities related to long-term leases on the balance sheets and expands disclosure requirements regarding leasing arrangements. The Company adopted this guidance on a modified retrospective basis and used the following practical expedients: · the Company did not reassess if any expired or existing contracts are or contain leases; · the Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing accounting policy elections whereby it (i) does not recognize Right-of-use (“ROU”) assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of operating leases. Upon adoption of the new guidance on January 1, 2019, the Company recorded right of use assets of approximately $3.0 million and recognized lease liabilities of approximately $3.2 million. There was no cumulative effect impact to accumulated deficit as of January 1, 2019. No adjustments were made to prior comparative periods. In January 2017, the FASB issued ASU No. 2017‑01, Clarifying the Definition of a Business (Topic 805). The amendments in the update provide a screen to determine when a set is not a business. If the screen is not met, the amendments in the update (1) require that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments provide a framework to assist entities in evaluating whether both an input and a substantive process are present. Lastly, the amendments in the update narrow the definition of the term output so that the term is consistent with how outputs are described in Topic 606. The ASU is effective for annual periods and interim periods within those annual periods beginning after December 15, 2017; earlier adoption is permitted under certain criteria. The Company adopted this ASU on January 1, 2018. While this ASU did not have a material effect on the Company’s financial statements on the date of adoption, the Company did follow the new guidance in determining that its acquisition of ANDAs from Sandoz in January 2018 and from Laurus Labs in October 2018 were asset acquisitions (see Notes 3 and 4). In May 2017, the FASB issued ASU 2017‑09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting . ASU 2017‑09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered nonsubstantive. This ASU is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted ASU 2017‑09 in the first quarter of 2018 and the adoption of this ASU did not have a material effect on the consolidated financial statements. In June 2018, the FASB issued ASU 2018‑07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting which includes updated guidance for share-based payment awards issued to non-employees. The updated standard aligns the accounting for share-based payment awards for non-employees with employees, except for guidance related to the attribution of compensation costs for non-employees. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those annual periods for public business entities, with early adoption permitted. The Company early adopted this standard on October 1, 2018. The adoption of this ASU did not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The new guidance requires a customer in a cloud computing arrangement (i.e., hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. Capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. The update is effective for calendar-year public business entities in 2020. For all other calendar-year entities, it is effective for annual periods beginning in 2021 and interim periods in 2022. Early adoption is permitted. The Company early adopted this guidance effective January 1, 2019. The net impact to the financial statements was approximately $140,000 of capitalized cost. Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments to the initial guidance including ASU No. 2018-19, ASU No. 2019-04, and ASU No. 2019-05 (collectively, “Topic 326”). Topic 326 requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for annual and interim periods beginning after December 15, 2019 and early adoption is permitted for annual and interim periods beginning after December 15, 2018. The adoption of the new standard is not expected to have a material impact on the consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting For Income Taxes. The new guidance removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for goodwill and allocating taxes to members of a consolidated group. The new guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently accessing the impact that the new standards will have on its consolidated financial statements. There are no other recently issued accounting pronouncements that are expected to have a material effect on the Company’s financial position, results of operations or cash flows. |
ACQUISITION OF ABBREVIATED NE_3
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ | |
Schedule Of Finite Lived Intangible Assets And Active Pharmaceutical Ingredient Inventory | ANDAs $ 18,608,000 API 564,000 Total value $ 19,172,000 |
INVESTMENT IN EQUITY SECURITI_2
INVESTMENT IN EQUITY SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INVESTMENT IN EQUITY SECURITIES | |
Schedule of investment | The following table summarizes the Company’s investment as of December 31, 2019: Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains value Common stock Investment $ — $ 625 $ 625 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INVENTORIES | |
Schedule of components of inventories | December 31 (In thousands) 2019 2018 Finished goods $ 4,514 $ — Raw materials 28 283 Total $ 4,542 $ 283 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
LEASES | |
Schedule of impact of Topic 842 on condensed consolidated balance sheet | (In thousands) December 31, 2019 Right of use assets $ 8,708 Accrued liabilities 1,182 Other liabilities 1,019 Total lease liabilities $ 2,201 |
Schedule of supplemental cash flow information | Year ended (In thousands) December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 1,315 Right of use assets obtained in exchange for lease obligations: $ 2,157 |
Schedule of future undiscounted cash flows | (In thousands) 2020 1,403 2021 892 2022 191 Thereafter — Total 2,486 Discount factor (285) Lease liability 2,201 Amounts due within 12 months 1,182 Non-current lease liability $ 1,019 |
Schedule of future minimum rental payments for operating leases | (In thousands) 2019 $ 1,312 2020 1,297 2021 857 2022 130 Thereafter — Total minimum payments $ 3,596 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT | |
Schedule of Property and equipment | Property and equipment consist of the following: (In thousands) December 31, 2019 2018 Furniture and equipment $ 1,305 $ 1,698 Leasehold improvements 792 739 Total property, plant and equipment, gross 2,097 2,437 Accumulated depreciation and amortization (726) (686) Impairment of property, plant and equipment (386) — $ 985 $ 1,751 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INTANGIBLE ASSETS | |
Schedule of net definite-lived intangible assets | (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 18,002 $ (3,122) 13 years TDF ANDA 2,035 (185) 13 years Others 210 (45) 5 years Total $ 20,247 $ (3,352) |
Schedule of changes in intangible assets | (In thousands) Balance as of December 31, 2018 $ 18,785 Additions 192 Disposal (408) Amortization expense (1,550) Foreign currency translation adjustment (124) Balance as of December 31, 2019 $ 16,895 |
Schedule of expected future amortization expense | (In thousands) 2020 $ 1,540 2021 1,540 2022 1,540 2023 1,540 2024 1,499 2025 and thereafter 9,236 |
REDEEMABLE NONCONTROLLING INT_2
REDEEMABLE NONCONTROLLING INTEREST (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
REDEEMABLE NONCONTROLLING INTEREST | |
Schedule of changes in redeemable noncontrolling interest | (In thousands) Balance as of December 31, 2018 $ — Cash contribution by Wuxi LP 20,000 Share of CASI Wuxi net loss (395) Accretion of redeemable noncontrolling interest 1,065 Balance as of December 31, 2019 $ 20,670 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
STOCKHOLDERS' EQUITY | |
Schedule of stock purchase warrants activity | Number of Weighted Average Warrants Exercise Price Outstanding at December 31, 2017 6,264,016 $ 2.23 Issued 8,271,709 $ 4.58 Exercised (2,753,900) $ 1.80 Expired — $ — Outstanding at December 31, 2018 11,781,825 $ 3.98 Issued — $ — Exercised (1,938,105) $ 1.69 Expired — $ — Outstanding at December 31, 2019 9,843,720 $ 4.43 Exercisable at December 31, 2019 9,843,720 $ 4.43 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
NET LOSS PER SHARE | |
Schedule of basic and diluted net loss per share | (In thousands, except per share data) Year Ended December 31, 2019 2018 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (46,032) $ (27,471) Denominator: Weighted average number of common shares 95,948 84,752 Denominator for basic and diluted net loss per share calculation 95,948 84,752 Net loss per share — Basic and diluted $ (0.48) $ (0.32) |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
STOCK-BASED COMPENSATION | |
Schedule of compensation expense | The Company’s net loss for the twelve months ended December 31, 2019 and 2018 includes $7,310,000 and $6,119,000, respectively, of non-cash compensation expense related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows: Year ended December, (In thousands) 2019 2018 Research and development $ 466 $ 741 General and administrative 6,844 5,378 Share-based compensation expense $ 7,310 $ 6,119 |
Schedule of weighted-average assumptions used in valuing the stock options | Following are the weighted-average assumptions used in valuing the stock options granted to employees during the years ended December 31, 2019 and 2018: Year ended December 31, 2019 2018 Expected volatility 77.30 % 78.78 % Risk free interest rate 1.87 % 2.80 % Expected term of option 6.05 years 5.77 years Expected dividend yield 0.00 % 0.00 % |
Schedule of stock option plans and of changes in options outstanding under the plans | A summary of the Company’s stock option plans and changes in options outstanding under the plans during the years ended December 31, 2019 and 2018 is as follows: Weighted Average Weighted Average Remaining Number of Options Exercise Price Contractual Term In Years Aggregate Intrinsic Value Outstanding at December 31, 2017 11,585,315 $ 1.42 Exercised (156,283) $ 1.65 $ 643,000 Granted 7,336,000 $ 4.01 Expired (285,594) $ 1.55 Forfeited (50,130) $ 3.28 Outstanding at December 31, 2018 18,429,308 $ 2.44 Exercised (599,002) $ 1.43 $ 1,124,000 Granted 5,834,808 $ 3.01 Expired (7,090) $ 3.69 Forfeited (1,389,652) $ 1.17 Cancelled (4,000,000) $ 3.22 Outstanding at December 31, 2019 18,268,372 $ 2.58 6.30 $ 16,414,546 Vested and expected to vest at December 31, 2019 18,018,372 $ 2.57 6.38 $ 16,414,546 Exercisable at December 31, 2019 11,192,819 $ 1.99 4.52 $ 15,311,057 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | The following summarizes information about stock options that are outstanding at December 31, 2019: Options Outstanding Options Exercisable Weighted Average Weighted Weighted Number Remaining Average Number Average Range of Outstanding at Contractual Exercise Exercisable at Exercise Exercise Prices December 31, 2019 Life in Years Price December 31, 2019 Price $0.00 - $1.00 2,193,853 3.70 $ 0.91 2,193,853 $ 0.91 $1.01 - $2.00 6,682,402 3.84 $ 1.52 6,605,614 $ 1.53 $2.01 - $4.00 7,511,301 8.81 $ 3.04 1,656,495 $ 3.11 $4.01 - $7.00 1,639,000 8.11 $ 6.25 495,041 $ 6.28 $7.01 - $9.00 241,816 7.22 $ 8.10 241,816 $ 8.10 18,268,372 6.30 $ 2.58 11,192,819 $ 1.99 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES | |
Schedule of Income before Income Tax, Domestic and Foreign | For financial reporting purposes, loss before income taxes includes the following components: (In thousands) 2019 2018 United States $ (28,957) $ (19,820) Foreign (16,405) (7,651) Total $ (45,362) $ (27,471) |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred income tax assets and liabilities as of December 31, 2019 and 2018 are as follows: December 31, (In thousands) 2019 2018 Deferred income tax assets: Net operating loss carryforwards $ 94,828 $ 97,701 Research and development credit carryforward 7,740 8,957 Intangible assets 5,733 4,378 Equity-based compensation 5,423 4,075 Other 396 81 Valuation allowance for deferred income tax assets (114,120) (115,192) Net deferred income tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the provision for income taxes to the federal statutory rate is as follows: (In thousands) 2019 2018 Tax benefit at statutory rate $ (9,526) $ (5,769) State taxes (1,701) (1,098) Attribute expiration 12,461 7,200 Nondeductible expenses 453 29 Other (608) (82) Change in applicable tax rates (7) (934) Change in valuation allowance (1,072) 654 $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: (In thousands) 2019 2018 Unrecognized tax benefits balance at January 1 $ 2,986 $ 3,198 Reductions for tax positions of prior periods (405) (214) Additions for tax positions of current period — 2 Unrecognized tax benefits balance at December 31 $ 2,581 $ 2,986 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
FAIR VALUE MEASUREMENTS | |
Schedule of assets and liabilities measured at fair value on recurring and nonrecurring basis | The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of December 31, 2019 and December 31, 2018, by level within the fair value hierarchy: (In thousands) Fair Value at December 31, Description 2019 Level 1 Level 2 Level 3 Investment in common stock $ 625 $ 625 $ — $ — Fair Value at December 31, Description 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912 $ 912 $ — $ — Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis Fair Value at December Description 31, 2019 Level 1 Level 2 Level 3 Long-lived assets $ 287 $ — $ — $ 287 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details) € in Millions, ¥ in Millions | Oct. 29, 2019EUR (€) | Jun. 30, 2019CNY (¥) | Jun. 30, 2019USD ($) | Apr. 30, 2019EUR (€) | Apr. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Description of Business and Basis of Presentation [Line Items] | |||||||
Inventory, Net | $ 4,542,000 | $ 283,000 | |||||
Retained Earnings (Accumulated Deficit) | (523,908,000) | (478,941,000) | |||||
Revenues | 4,131,000 | $ 0 | |||||
Black Belt TX Limited [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Payments to Acquire Equity Method Investments | € 2 | $ 2,249,600 | |||||
Equity Method Investment, Ownership Percentage | 15.00% | 15.00% | |||||
Juventas Cell Therapy Ltd [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Payments to Acquire Equity Method Investments | ¥ 80 | $ 11,788,000 | |||||
Equity Method Investment, Ownership Percentage | 16.30% | 16.30% | |||||
Pharmathen Global BV [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Upfront Payment For a License For a Drug | € | € 1 | ||||||
Non Royalty Exclusive Distribution Period | 10 years | ||||||
Non Royalty Exclusive Distribution, Supply Cost Determination, Period Considered | 3 years | ||||||
Black Belt Therapeutics Limited [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Upfront Payment | € 5 | $ 5,657,500 | |||||
Maximum [Member] | Pharmathen Global BV [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Additional milestone payments | € | € 2 | ||||||
License Agreement Terms [Member] | Black Belt Therapeutics Limited [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Upfront Payment | € | € 5 | ||||||
EVOMELA [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Revenues | 4,100,000 | ||||||
CASI China [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Cash | 2,600,000 | ||||||
CASI Wuxi [Member] | |||||||
Description of Business and Basis of Presentation [Line Items] | |||||||
Cash | $ 22,100,000 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | Jan. 02, 2018 | Jan. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2019 |
Accounting Policies [Line Items] | |||||
Impairment of property, plant and equipment | $ 386,000 | $ 0 | |||
Cumulative Effect on Retained Earnings, Net of Tax | $ 1,200,000 | 1,232,000 | |||
Operating Lease, Right-of-Use Asset | 8,708,000 | $ 0 | |||
Operating Lease, Liability | $ 2,201,000 | ||||
New Accounting Pronouncement or Change in Accounting Principle, Effect | $ 140,000 | ||||
Accounting Standards Update 2016-02 [Member] | |||||
Accounting Policies [Line Items] | |||||
Operating Lease, Right-of-Use Asset | $ 3,000,000 | ||||
Operating Lease, Liability | $ 3,200,000 | ||||
Options And Warrants [Member] | |||||
Accounting Policies [Line Items] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 28,112,092 | 30,211,133 |
ACQUISITION OF ABBREVIATED NE_4
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Purchase Price For Finite lived Intangible Assets Acquired | $ 19,172,000 |
Abbreviated New Drug Applications [Member] | |
Purchase Price For Finite lived Intangible Assets Acquired | 18,608,000 |
Active Pharmaceutical Ingredient [Member] | |
Purchase Price For Finite lived Intangible Assets Acquired | $ 564,000 |
ACQUISITION OF ABBREVIATED NE_5
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ (Details Textual) - USD ($) | Jan. 26, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Research and Developments in Process | $ 6,967,000 | $ 687,000 | |
Payments to Acquire Intangible Assets | $ 18,000,000 | $ 0 | 20,643,000 |
Abbreviated New Drug Applications [Member] | |||
Research and Developments in Process | 553,000 | ||
Asset Acquisition Transaction Costs | $ 1,200,000 | ||
Finite-Lived Intangible Asset, Useful Life | 13 years | ||
Active Pharmaceutical Ingredient [Member] | |||
Research and Developments in Process | $ 134,000 |
ACQUISITION OF ABBREVIATED NE_6
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS (Details) - USD ($) | Jan. 26, 2018 | Oct. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Abbreviated New Drug Applications [Member] | ||||
Asset Acquisition Transaction Costs | $ 1,200,000 | |||
Finite-Lived Intangible Asset, Useful Life | 13 years | |||
Laurus Lab [Member] | ||||
Purchase Price Of Drug | $ 3,000,000 | |||
Upfront Payment For Drug | 700,000 | |||
Asset Acquisition Transaction Costs | $ 35,121 | |||
Contingent Consideration Paid | $ 1,300,000 | |||
Remaining Amount Of Future Contingent Consideration | $ 1,000,000 | |||
Laurus Lab [Member] | Abbreviated New Drug Applications [Member] | ||||
Finite-Lived Intangible Asset, Useful Life | 13 years |
INVESTMENT IN EQUITY SECURITI_3
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS - Summary of Investment (Details) - Common Stock [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Cost | $ 0 |
Gross unrealized gains | 625 |
Aggregate fair value | $ 625 |
INVESTMENT IN EQUITY SECURITI_4
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS - Additional Information (Details) € in Millions, ¥ in Millions | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2019CNY (¥) | Jun. 30, 2019USD ($) | Apr. 30, 2019EUR (€) | Apr. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Change in fair value of investment in equity securities | $ 288,000 | $ 320,000 | ||||
Juventas Cell Therapy Ltd [Member] | ||||||
Payments to Acquire Equity Method Investments | ¥ 80 | $ 11,788,000 | ||||
Black Belt TX Limited [Member] | ||||||
Payments to Acquire Equity Method Investments | € 2 | $ 2,249,600 |
INVESTMENT IN EQUITY SECURITI_5
INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND LONG-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Change in fair value of investment in equity securities | $ 288 | $ 320 |
Retained Earnings (Accumulated Deficit) | (523,908) | (478,941) |
Fair Value, Inputs, Level 1 [Member] | ||
Equity Method Investments, Fair Value Disclosure | $ 600 | $ 900 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
INVENTORIES | ||
Finished goods | $ 4,514 | $ 0 |
Raw materials | 28 | 283 |
Inventory, Net, Total | 4,542 | 283 |
Write down of obsolete inventories | $ 152 | $ 0 |
LEASES - Impact of Topic 842 (D
LEASES - Impact of Topic 842 (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Right of use assets | $ 8,708 | $ 0 |
Operating Lease, Liability | $ 2,201 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities, Current | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent | |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent us-gaap:OtherLiabilitiesNoncurrent | |
Accounts Payable and Accrued Liabilities [Member] | ||
Operating Lease, Liability | $ 1,182 | |
Other Liabilities [Member] | ||
Operating Lease, Liability | $ 1,019 |
LEASES - Supplemental Cash Flow
LEASES - Supplemental Cash Flow (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows | $ 1,315 |
Right of use assets obtained in exchange for lease obligations: | $ 2,157 |
LEASES - Future Undiscounted Ca
LEASES - Future Undiscounted Cash Flows (Details) $ in Thousands | Dec. 31, 2019USD ($) |
LEASES | |
2020 | $ 1,403 |
2021 | 892 |
2022 | 191 |
Thereafter | 0 |
Total | 2,486 |
Discount factor | (285) |
Lease liability | 2,201 |
Amounts due within 12 months | 1,182 |
Non-current lease liability | $ 1,019 |
LEASES - Future Annual Lease Pa
LEASES - Future Annual Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
LEASES | |
2019 | $ 1,312 |
2020 | 1,297 |
2021 | 857 |
2022 | 130 |
Thereafter | 0 |
Total minimum payments | $ 3,596 |
LEASES - Additional Information
LEASES - Additional Information (Details) ¥ in Millions | 12 Months Ended | |||
Dec. 31, 2019CNY (¥)lease | Dec. 31, 2019USD ($)lease | Dec. 31, 2018USD ($) | Nov. 30, 2019m² | |
Number of Operating Leases | lease | 5 | 5 | ||
Operating Lease, Weighted Average Remaining Lease Term | 49 years 1 month 28 days | 49 years 1 month 28 days | ||
Operating Lease, Weighted Average Discount Rate, Percent | 5.16% | 5.16% | ||
Operating Lease, Cost | $ 1,315,000 | |||
Operating Leases, Rent Expense, Net | $ 916,000 | |||
CASI Wuxi [Member] | ||||
Term of the lease contract | 50 years | |||
Land parcel area (in square meters) | m² | 74,028.40 | |||
Prepaid lease payments for the land use right | ¥ 45 | $ 6,600,000 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
PROPERTY AND EQUIPMENT | ||
Furniture and equipment | $ 1,305 | $ 1,698 |
Leasehold improvements | 792 | 739 |
Total property, plant and equipment, gross | 2,097 | 2,437 |
Accumulated depreciation and amortization | (726) | (686) |
Impairment of property, plant and equipment | 386 | 0 |
Property, Plant and Equipment, Net, Total | $ 985 | $ 1,751 |
PROPERTY AND EQUIPMENT - Additi
PROPERTY AND EQUIPMENT - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Depreciation, Depletion and Amortization | $ 603,000 | $ 366,000 |
Maximum [Member] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Minimum [Member] | ||
Property, Plant and Equipment, Useful Life | 3 years |
INTANGIBLE ASSETS - Net Definit
INTANGIBLE ASSETS - Net Definite-lived Intangible Assets (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | $ 20,247 |
Accumulated Amortization | (3,352) |
Abbreviated New Drug Applications [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | 18,002 |
Accumulated Amortization | $ (3,122) |
Estimated useful lives | 13 years |
Abbreviated New Drug Applications TDF [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | $ 2,035 |
Accumulated Amortization | $ (185) |
Estimated useful lives | 13 years |
Cloud Computing Arrangement [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 5 years |
Others [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | $ 210 |
Accumulated Amortization | $ (45) |
Estimated useful lives | 5 years |
INTANGIBLE ASSETS - Changes in
INTANGIBLE ASSETS - Changes in intangible assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
INTANGIBLE ASSETS | ||
Balance as of December 31, 2018 | $ 18,785 | |
Additions | 192 | |
Disposal | (408) | |
Amortization expenses | (1,550) | $ (1,305) |
Foreign currency translation adjustments | (124) | |
Balance as of December 31, 2019 | $ 16,895 | $ 18,785 |
INTANGIBLE ASSETS - Expected Fu
INTANGIBLE ASSETS - Expected Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2019USD ($) |
INTANGIBLE ASSETS | |
2020 | $ 1,540 |
2021 | 1,540 |
2022 | 1,540 |
2023 | 1,540 |
2024 | 1,499 |
2025 and thereafter | $ 9,236 |
INTANGIBLE ASSETS - Additional
INTANGIBLE ASSETS - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Abbreviated New Drug Applications [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Finite-Lived Intangible Asset, Useful Life | 13 years |
Cloud Computing Arrangement [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Finite-Lived Intangible Asset, Useful Life | 5 years |
NOTE PAYABLE (Details)
NOTE PAYABLE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Notes Payable [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 0.50% | |
Interest Expense | $ 5,600 | $ 7,500 |
Spectrum Pharmaceuticals [Member] | ||
Notes Payable [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 0.50% | |
Debt Instrument Initial Discount Upon Issuance | $ 136,000 | |
Debt Instrument, Face Amount | $ 1,500,000 |
REDEEMABLE NONCONTROLLING INT_3
REDEEMABLE NONCONTROLLING INTEREST - Changes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
REDEEMABLE NONCONTROLLING INTEREST | ||
Balance at beginning of period | $ 0 | |
Cash contribution by Wuxi LP | 20,000 | $ 0 |
Share of CASI Wuxi net loss | (395) | 0 |
Accretion of redeemable noncontrolling interest | 1,065 | |
Balance at end of period | $ 20,670 | $ 0 |
REDEEMABLE NONCONTROLLING INT_4
REDEEMABLE NONCONTROLLING INTEREST - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 28, 2019 | Dec. 26, 2018 | |
CASI Wuxi [Member] | |||
Noncontrolling Interest [Line Items] | |||
Equity Method Investment, Ownership Percentage | 80.00% | ||
Investment Commitment | $ 80 | ||
Initial Cash Investment | $ 21 | ||
Value of a future transfer of selected ANDAs | $ 30 | ||
Payments To Be Paid Within Three Years | $ 29 | ||
Call Option To Purchase Investment Period | 5 years | ||
Payments to Acquire Investments | $ 20 | ||
CASI Wuxi [Member] | Call Option [Member] | |||
Noncontrolling Interest [Line Items] | |||
Equity Method Investment, Ownership Percentage | 20.00% | ||
CASI Wuxi [Member] | Put Option [Member] | |||
Noncontrolling Interest [Line Items] | |||
Equity Method Investment, Ownership Percentage | 20.00% | ||
CASI Wuxi [Member] | |||
Noncontrolling Interest [Line Items] | |||
Payments to Acquire Investments | $ 20 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Outstanding at Number of Warrants, Beginning Balance | 11,781,825 | 6,264,016 |
Issued Number of Warrants | 0 | 8,271,709 |
Exercised Number of Warrants | (1,938,105) | (2,753,900) |
Expired Number of Warrants | 0 | 0 |
Outstanding at Number of Warrants, Ending Balance | 9,843,720 | 11,781,825 |
Exercisable Number of Warrants | 9,843,720 | |
Outstanding Weighted Average Exercise Price, Beginning Balance | $ 3.98 | $ 2.23 |
Issued Weighted Average Exercise Price | 0 | 4.58 |
Exercised Weighted Average Exercise Price | 1.69 | 1.80 |
Expired Weighted Average Exercise Price | 0 | 0 |
Outstanding Weighted Average Exercise Price, at Ending Balance | 4.43 | $ 3.98 |
Exercisable Weighted Average Exercise Price | $ 4.43 |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional Information (Details) - USD ($) | Jul. 19, 2019 | Sep. 30, 2018 | Sep. 17, 2018 | Mar. 31, 2018 | Apr. 30, 2018 | Mar. 16, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 23, 2019 |
Remaining Dollar Amount Available Under Sales Agreement | $ 19,500,000 | ||||||||
Stock Issued During Period, Shares, New Issues | 6,996,266 | ||||||||
Price Per Share and Warrant | $ 3.24 | ||||||||
Common Stock, Shares Authorized | 250,000,000 | 170,000,000 | |||||||
Treasury Stock, Shares | 79,545 | 79,545 | |||||||
Number of Warrants to Purchase Common Stock Issued During the Period | 2,098,877 | ||||||||
Proceeds from Issuance of Common Stock and Warrants Gross | $ 37,500,000 | ||||||||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | |||||||
Remaining Dollar Amount Available Under Sales Agreement | $ 19,500,000 | ||||||||
Measurement Input, Expected Term [Member] | |||||||||
Fair Value Assumptions Term | 3 years | ||||||||
Investor [Member] | |||||||||
Stock To Be Issued, Shares | 9,048,504 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.69 | ||||||||
Warrants To Be Issued | 2,714,548 | ||||||||
Stock Issued During Period, Shares, New Issues | 15,432,091 | ||||||||
Class Of Warrant Or Right Expiration Date | Mar. 21, 2023 | ||||||||
Price Per Share and Warrant | $ 5.36 | ||||||||
Number of Warrants to Purchase Common Stock Issued During the Period | 6,172,832 | ||||||||
Securities Purchase Agreements [Member] | |||||||||
Fair Value Of Warrant Issued | $ 6,254,653 | $ 15,062,000 | |||||||
Fair Value Assumptions Fair Value | $ 2.98 | $ 2.44 | |||||||
Class Of Warrant Or Right Expiration Date | Sep. 24, 2021 | ||||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Mar. 23, 2019 | ||||||||
Securities Purchase Agreements [Member] | Measurement Input, Expected Term [Member] | |||||||||
Fair Value Assumptions Term | 5 years | ||||||||
Securities Purchase Agreements [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||
Fair Value Assumptions Rate | 2.89% | 2.69% | |||||||
Securities Purchase Agreements [Member] | Measurement Input, Price Volatility [Member] | |||||||||
Fair Value Assumptions Rate | 88.39% | 75.40% | |||||||
Private Placement [Member] | |||||||||
Proceeds from Issuance of Common Stock and Warrants Gross | $ 50,000,000 | ||||||||
Private Placement [Member] | Investor [Member] | |||||||||
Stock And Warrants To Be Issued Value | $ 48,500,000 | ||||||||
Sales Agreement [Member] | |||||||||
Net Proceeds From Issuance Of Common Stock | $ 475,000 | ||||||||
Stock Issued During Period, Shares, New Issues | 143,248 | ||||||||
Warrant [Member] | Investor [Member] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.19 | ||||||||
Open Market Sale Agreement [Member] | |||||||||
Maximum Sales Price from Issuance of Common Stock | $ 30,000,000 | ||||||||
Remaining Dollar Amount Available Under Sales Agreement | 29,800,000 | ||||||||
Net Proceeds From Issuance Of Common Stock | $ 1,357,000 | $ 182,000 | |||||||
Stock Issued During Period, Shares, New Issues | 434,336 | 58,904 | |||||||
Remaining Dollar Amount Available Under Sales Agreement | $ 29,800,000 | ||||||||
Amendment To Open Sale Agreement [Member] | |||||||||
Maximum Sales Price from Issuance of Common Stock | $ 20,000,000 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Options And Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 28,112,092 | 30,211,133 |
NET LOSS PER SHARE - Basic and
NET LOSS PER SHARE - Basic and diluted net loss per share computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator: | ||
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (46,032) | $ (27,471) |
Denominator: | ||
Weighted average number of common shares | 95,948 | 84,752 |
Denominator for basic and diluted net loss per share calculation | 95,948 | 84,752 |
Net loss per share - Basic and diluted (in dollars per share) | $ (0.48) | $ (0.32) |
EMPLOYEE BENEFIT PLAN (Details)
EMPLOYEE BENEFIT PLAN (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
EMPLOYEE BENEFIT PLAN | ||
Defined Benefit Plan, Plan Assets, Contributions by Employer | $ 217,000 | $ 151,000 |
Defined contribution plan expenses | $ 1,780,000 | $ 724,000 |
STOCK-BASED COMPENSATION - Comp
STOCK-BASED COMPENSATION - Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 7,310 | $ 6,119 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 466 | 741 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 6,844 | $ 5,378 |
STOCK-BASED COMPENSATION - Weig
STOCK-BASED COMPENSATION - Weighted-Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
STOCK-BASED COMPENSATION | ||
Expected volatility | 77.30% | 78.78% |
Risk free interest rate | 1.87% | 2.80% |
Expected term of option | 6 years 18 days | 5 years 9 months 7 days |
Expected dividend yield | 0.00% | 0.00% |
STOCK-BASED COMPENSATION - Opti
STOCK-BASED COMPENSATION - Options Outstanding (Details) - Employee Stock Option [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding - Number of Options, Beginning Balance | 18,429,308 | 11,585,315 |
Exercised - Number of Options | (599,002) | (156,283) |
Granted - Number of Options | 5,834,808 | 7,336,000 |
Expired - Number of Options | (7,090) | (285,594) |
Forfeited - Number of Options | (1,389,652) | (50,130) |
Cancelled - Number of Options | (4,000,000) | |
Outstanding - Number of Options, Ending Balance | 18,268,372 | 18,429,308 |
Vested and expected to vest - Number of options | 18,018,372 | |
Exercisable - Number of options | 11,192,819 | |
Outstanding - Weighted Average Exercise Price, Beginning balance | $ 2.44 | $ 1.42 |
Exercised - Weighted Average Exercise Price | 1.43 | 1.65 |
Granted - Weighted Average Exercise Price | 3.01 | 4.01 |
Expired - Weighted Average Exercise Price | 3.69 | 1.55 |
Forfeited - Weighted Average Exercise Price | 1.17 | 3.28 |
Cancelled - Weighted Average Exercise Price | 3.22 | |
Outstanding - Weighted Average Exercise Price, Ending Balance | 2.58 | $ 2.44 |
Vested and expected to vest - Weighted Average Exercise Price | 2.57 | |
Exercisable - Weighted Average Exercise Price | $ 1.99 | |
Outstanding - Weighted Average Remaining Contractual Term In Years | 6 years 3 months 18 days | |
Vested and expected to vest - Weighted Average Remaining Contractual Term In Years | 6 years 4 months 17 days | |
Exercisable - Weighted Average Remaining Contractual Term In Years | 4 years 6 months 7 days | |
Exercised - Aggregate Intrinsic Value | $ 1,124,000 | $ 643,000 |
Outstanding - Aggregate Intrinsic Value | 16,414,546 | |
Vested and expected to vest - Aggregate Intrinsic Value | 16,414,546 | |
Exercisable - Aggregate Intrinsic Value | $ 15,311,057 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Outstanding (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Number Of Options Outstanding at December 31,2019 | shares | 18,268,372 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 6 years 3 months 18 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 2.58 |
Number Of Options Exercisable at December 31, 2019 | shares | 11,192,819 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.99 |
Range One [Member] | |
Range of Exercise Prices Lower Range Limit | 0 |
Range of Exercise Prices Upper Range Limit | $ 1 |
Number Of Options Outstanding at December 31,2019 | shares | 2,193,853 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 3 years 8 months 12 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 0.91 |
Number Of Options Exercisable at December 31, 2019 | shares | 2,193,853 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 0.91 |
Range Two [Member] | |
Range of Exercise Prices Lower Range Limit | 1.01 |
Range of Exercise Prices Upper Range Limit | $ 2 |
Number Of Options Outstanding at December 31,2019 | shares | 6,682,402 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 3 years 10 months 2 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.52 |
Number Of Options Exercisable at December 31, 2019 | shares | 6,605,614 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.53 |
Range Three [Member] | |
Range of Exercise Prices Lower Range Limit | 2.01 |
Range of Exercise Prices Upper Range Limit | $ 4 |
Number Of Options Outstanding at December 31,2019 | shares | 7,511,301 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 8 years 9 months 22 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 3.04 |
Number Of Options Exercisable at December 31, 2019 | shares | 1,656,495 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 3.11 |
Range Four [Member] | |
Range of Exercise Prices Lower Range Limit | 4.01 |
Range of Exercise Prices Upper Range Limit | $ 7 |
Number Of Options Outstanding at December 31,2019 | shares | 1,639,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 8 years 1 month 10 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 6.25 |
Number Of Options Exercisable at December 31, 2019 | shares | 495,041 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 6.28 |
Range Five [Member] | |
Range of Exercise Prices Lower Range Limit | 7.01 |
Range of Exercise Prices Upper Range Limit | $ 9 |
Number Of Options Outstanding at December 31,2019 | shares | 241,816 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 2 months 19 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 8.10 |
Number Of Options Exercisable at December 31, 2019 | shares | 241,816 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 8.10 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.20 | $ 4.49 | |||
Performance Share Based Compensation Expense | $ 73,000 | $ 644,000 | |||
Share Based Payment Cash Received from Stock Option Exercises | 854,000 | $ 258,000 | |||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | $ 13,639,000 | ||||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | 2 years 2 months 12 days | ||||
Executive Chairman [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,000,000 | ||||
Performance Based Option [Member] | Former Chief Executive Officer [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 4,000,000 | ||||
Cancelled Shares of Common Stock | 4,000,000 | ||||
Performance Based Option [Member] | Executive Chairman [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 2.85 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 4,000,000 | ||||
Long Term Incentive Plan2011 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 11,389,078 | ||||
Long Term Incentive Plan2011 [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 20,230,000 | ||||
Long Term Incentive Plan2011 [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 25,230,000 |
INCOME TAXES - Loss Before Inco
INCOME TAXES - Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
INCOME TAXES | ||
United States | $ (28,957) | $ (19,820) |
Foreign | (16,405) | (7,651) |
Total | $ (45,362) | $ (27,471) |
INCOME TAXES - Deferred Income
INCOME TAXES - Deferred Income Tax Assets And Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred income tax assets: | ||
Net operating loss carryforwards | $ 94,828 | $ 97,701 |
Research and development credit carryforward | 7,740 | 8,957 |
Intangible assets | 5,733 | 4,378 |
Equity-based compensation | 5,423 | 4,075 |
Other | 396 | 81 |
Valuation allowance for deferred income tax assets | (114,120) | (115,192) |
Net deferred income tax assets | $ 0 | $ 0 |
INCOME TAXES - Reconciliation O
INCOME TAXES - Reconciliation Of The Provision For Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
INCOME TAXES | ||
Tax benefit at statutory rate | $ (9,526) | $ (5,769) |
State taxes | (1,701) | (1,098) |
Attribute expiration | 12,461 | 7,200 |
Nondeductible expenses | 453 | 29 |
Other | (608) | (82) |
Change in applicable tax rates | (7) | (934) |
Change in valuation allowance | (1,072) | 654 |
Total | $ 0 | $ 0 |
INCOME TAXES - Gross Unrecogniz
INCOME TAXES - Gross Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
INCOME TAXES | ||
Unrecognized Tax Benefits, Beginning Balance | $ 2,986 | $ 3,198 |
Reductions for Tax Positions of Prior Periods | (405) | (214) |
Additions for Tax Positions of Current Period | 0 | 2 |
Unrecognized Tax Benefits, Ending Balance | $ 2,581 | $ 2,986 |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits | $ 2,581,000 | $ 2,986,000 | $ 3,198,000 |
Tax Credit Carryforward, Amount | $ 7,740,000 | ||
Operating Loss Carryforwards, Limitations on Use | NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50% | ||
State and Local Jurisdiction [Member] | |||
Income Tax Contingency [Line Items] | |||
Operating Loss Carryforwards | $ 356,300,000 | ||
Foreign Tax Authority [Member] | |||
Income Tax Contingency [Line Items] | |||
Operating Loss Carryforwards | 25,000,000 | ||
Research Tax Credit Carryforward [Member] | |||
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits | $ 405,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investment in common stock | $ 625,000 | $ 912,000 |
Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-lived assets | 287,000 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investment in common stock | 625,000 | 912,000 |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-lived assets | 0 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investment in common stock | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-lived assets | 0 | |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investment in common stock | 0 | $ 0 |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-lived assets | $ 287,000 |
FAIR VALUE MEASUREMENTS - Addit
FAIR VALUE MEASUREMENTS - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying amount | $ 2,097,000 | $ 2,437,000 |
Impairment of equipment | 386,000 | 0 |
Equipment leased to Juventas [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying amount | 673,000 | |
Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets, measured at fair value | 0 | 0 |
Financial liabilities, measured at fair value | 0 | 0 |
Long-lived assets | 287,000 | |
Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Non-financial assets, measured at fair value | 0 | 0 |
Non-financial liabilities, measured at fair value | $ 0 | $ 0 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | Jul. 01, 2019CNY (¥) | Jul. 01, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Related Party Transaction [Line Items] | ||||
Inventories | $ 4,542,000 | $ 283,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 0.50% | |||
Prepaid Expenses and Other Current Assets [Member] | ||||
Related Party Transaction [Line Items] | ||||
Payments | $ 4,900,000 | |||
EVOMELA [Member] | ||||
Related Party Transaction [Line Items] | ||||
Accounts Payable, Related Parties, Current | 200,000 | |||
Amount of Expense Incurred | 2,600,000 | |||
Spectrum [Member] | ||||
Related Party Transaction [Line Items] | ||||
Debt Instrument, Face Amount | 1,500,000 | |||
Spectrum [Member] | EVOMELA [Member] | ||||
Related Party Transaction [Line Items] | ||||
Related Party Transaction, Purchases from Related Party | 7,600,000 | 9,200,000 | ||
Juventas Cell Therapy Ltd [Member] | ||||
Related Party Transaction [Line Items] | ||||
Lessor, Operating Lease, Term of Contract | 1 year | 1 year | ||
Operating Lease, Lease Income, Lease Payments | ¥ 80,000 | $ 15,000 | ||
Operating Lease, Lease Income | $ 69,000 | 68,000 | ||
General and Administrative Expense [Member] | Emerging Technology Partners LLC [Member] | ||||
Related Party Transaction [Line Items] | ||||
Business Development | 1,500,000 | |||
Cost of Sales [Member] | ||||
Related Party Transaction [Line Items] | ||||
Inventories | $ 3,300,000 | |||
Chief Executive Officer and Board of Directors Chairman [Member] | ||||
Related Party Transaction [Line Items] | ||||
Related Party Transaction, Expenses from Transactions with Related Party | 1,380,000 | |||
Former Chief Executive Officer [Member] | ||||
Related Party Transaction [Line Items] | ||||
Related Party Transaction, Expenses from Transactions with Related Party | $ 120,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions, ¥ in Billions | 1 Months Ended | 12 Months Ended | |
Nov. 30, 2019CNY (¥) | Dec. 31, 2019USD ($) | Nov. 30, 2019USD ($) | |
Spectrum [Member] | EVOMELA [Member] | |||
Purchase obligation to purchase materials | $ 9.2 | ||
CASI Wuxi [Member] | |||
land use right and property, plant and equipment, commitment amount | ¥ 1 | $ 143 | |
Fixed assets investment, threshold period | 3 years |