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CASI Pharmaceuticals, Inc. – ‘20-F’ for 12/31/23 – ‘R31’

On:  Thursday, 3/28/24, at 11:01am ET   ·   For:  12/31/23   ·   Accession #:  1558370-24-4190   ·   File #:  1-41666

Previous ‘20-F’:  ‘20-F’ on 4/26/23 for 12/31/22   ·   Latest ‘20-F’:  This Filing   ·   15 References:   

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  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 3/28/24  CASI Pharmaceuticals, Inc.        20-F       12/31/23  142:21M                                    Toppan Merrill Bridge/FA

Annual or Annual-Transition Report by a Foreign Non-Canadian Issuer   —   Form 20-F   —   SEA’34

Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 20-F        Annual or Annual-Transition Report by a Foreign     HTML   3.52M 
                Non-Canadian Issuer                                              
 2: EX-1.1      Underwriting Agreement or Conflict Minerals Report  HTML   1.36M 
 3: EX-2.1      Plan of Acquisition, Reorganization, Arrangement,   HTML     58K 
                Liquidation or Succession                                        
 4: EX-4.29     Instrument Defining the Rights of Security Holders  HTML    230K 
 5: EX-4.37     Instrument Defining the Rights of Security Holders  HTML   1.10M 
 6: EX-4.38     Instrument Defining the Rights of Security Holders  HTML    321K 
 7: EX-4.39     Instrument Defining the Rights of Security Holders  HTML     56K 
 8: EX-4.40     Instrument Defining the Rights of Security Holders  HTML    336K 
 9: EX-4.41     Instrument Defining the Rights of Security Holders  HTML    315K 
10: EX-4.42     Instrument Defining the Rights of Security Holders  HTML    140K 
11: EX-4.43     Instrument Defining the Rights of Security Holders  HTML    128K 
12: EX-4.44     Instrument Defining the Rights of Security Holders  HTML    121K 
13: EX-4.45     Instrument Defining the Rights of Security Holders  HTML    314K 
14: EX-4.46     Instrument Defining the Rights of Security Holders  HTML     92K 
15: EX-4.47     Instrument Defining the Rights of Security Holders  HTML    122K 
16: EX-4.48     Instrument Defining the Rights of Security Holders  HTML     60K 
17: EX-8.1      Opinion of Counsel re: Tax Matters                  HTML     38K 
21: EX-13.1     Annual or Quarterly Report to Security Holders      HTML     41K 
22: EX-13.2     Annual or Quarterly Report to Security Holders      HTML     41K 
24: EX-97.1     Clawback Policy re: Recovery of Erroneously         HTML     62K 
                Awarded Compensation                                             
18: EX-11.1     Statement re: the Computation of Earnings Per       HTML     67K 
                Share                                                            
19: EX-12.1     Statement re: the Computation of Ratios             HTML     44K 
20: EX-12.2     Statement re: the Computation of Ratios             HTML     44K 
23: EX-15.1     Letter re: Unaudited Interim Financial Info         HTML     38K 
30: R1          Document and Entity Information                     HTML    115K 
31: R2          Consolidated Balance Sheets                         HTML    147K 
32: R3          Consolidated Balance Sheets (Parenthetical)         HTML     50K 
33: R4          Consolidated Statements of Operations and           HTML    185K 
                Comprehensive Loss                                               
34: R5          Consolidated Statements of Stockholders' Equity     HTML     90K 
35: R6          Consolidated Statements of Cash Flows               HTML    188K 
36: R7          Description of Business                             HTML     87K 
37: R8          Summary of Significant Accounting Policies          HTML     96K 
38: R9          Investment in Equity Securities, at Fair Value and  HTML    187K 
                Long-Term Investments                                            
39: R10         Inventories                                         HTML     41K 
40: R11         Leases                                              HTML     89K 
41: R12         Property, Plant and Equipment                       HTML     61K 
42: R13         Intangible Assets                                   HTML    111K 
43: R14         Accrued and Other Current Liabilities, and Other    HTML     76K 
                Liabilities                                                      
44: R15         Short Term Borrowings                               HTML     43K 
45: R16         Notes Payable                                       HTML     45K 
46: R17         Grants                                              HTML     42K 
47: R18         Redeemable Noncontrolling Interest and Long Term    HTML     68K 
                Borrowing                                                        
48: R19         Shareholders' Equity                                HTML     66K 
49: R20         Costs of Revenues                                   HTML     40K 
50: R21         Net Loss Per Share                                  HTML     65K 
51: R22         Employee Benefit Plan                               HTML     42K 
52: R23         Share-Based Compensation                            HTML    182K 
53: R24         Income Taxes                                        HTML    159K 
54: R25         Fair Value Measurements                             HTML    118K 
55: R26         Related Party Transactions                          HTML     48K 
56: R27         Commitments and Contingencies                       HTML     44K 
57: R28         Restricted Net Assets                               HTML     41K 
58: R29         Subsequent Events                                   HTML     41K 
59: R30         Condensed Financial Information of Registrant       HTML    220K 
60: R31         Summary of Significant Accounting Policies          HTML    164K 
                (Policies)                                                       
61: R32         Summary of Significant Accounting Policies          HTML     50K 
                (Tables)                                                         
62: R33         Investment in Equity Securities, at Fair Value and  HTML    170K 
                Long-Term Investments (Tables)                                   
63: R34         Leases (Tables)                                     HTML     88K 
64: R35         Property, Plant and Equipment (Tables)              HTML     57K 
65: R36         Intangible Assets (Tables)                          HTML    111K 
66: R37         Accrued and Other Current Liabilities, and Other    HTML     76K 
                Liabilities (Tables)                                             
67: R38         Redeemable Noncontrolling Interest (Tables)         HTML     61K 
68: R39         Shareholders' Equity (Tables)                       HTML     53K 
69: R40         Net Loss Per Share (Tables)                         HTML     64K 
70: R41         Share-Based Compensation (Tables)                   HTML    180K 
71: R42         Income Taxes (Tables)                               HTML    159K 
72: R43         Fair Value Measurements (Tables)                    HTML    117K 
73: R44         Condensed Financial Information of Registrant       HTML    222K 
                (Tables)                                                         
74: R45         DESCRIPTION OF BUSINESS - Liquidity and Capital     HTML    111K 
                Resources (Details)                                              
75: R46         DESCRIPTION OF BUSINESS - License and Distribution  HTML     51K 
                Agreements (China Resources Pharmaceutical                       
                Commercial Group International Trading Co., Ltd.)                
                (Details)                                                        
76: R47         DESCRIPTION OF BUSINESS - License and Distribution  HTML     50K 
                Agreements (Precision Autoimmune Therapeutics Co.,               
                Ltd) (Details)                                                   
77: R48         DESCRIPTION OF BUSINESS - License and Distribution  HTML     47K 
                Agreements (Juventas Cell Therapy Ltd.) (Details)                
78: R49         DESCRIPTION OF BUSINESS - License and Distribution  HTML     72K 
                Agreements (BioInvent International AB) (Details)                
79: R50         DESCRIPTION OF BUSINESS - License and Distribution  HTML     54K 
                Agreements (Black Belt Therapeutics Limited)                     
                (Details)                                                        
80: R51         DESCRIPTION OF BUSINESS - License and Distribution  HTML     56K 
                Agreements (Cleave Therapeutics, Inc.) (Details)                 
81: R52         DESCRIPTION OF BUSINESS - License and Distribution  HTML     48K 
                Agreements (Pharmathen Global BV) (Details)                      
82: R53         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -        HTML     41K 
                Consolidation (Details)                                          
83: R54         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -        HTML     40K 
                Segment Reporting (Details)                                      
84: R55         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash   HTML     47K 
                and Cash Equivalents (Details)                                   
85: R56         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -        HTML     46K 
                Aggregate Cost And Fair Value (Details)                          
86: R57         Summary of Significant Accounting Policies - Ppe    HTML     48K 
                (Details)                                                        
87: R58         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     66K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-MaxCyte Inc. (Details)                 
88: R59         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     94K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-BioInvent International                
                AB ordinary shares and warrants (Details)                        
89: R60         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     71K 
                LONG-TERM INVESTMENTS - BioInvent International AB               
                - Summary of Investments (Details)                               
90: R61         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     66K 
                LONG-TERM INVESTMENTS - Summary of Long-term                     
                investments (Details)                                            
91: R62         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     86K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-Juventas Cell Therapy                  
                Ltd. (Details)                                                   
92: R63         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     89K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-Alesta Therapeutics B.V.               
                (Details)                                                        
93: R64         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     78K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-Cleave Therapeutics,                   
                Inc. (Details)                                                   
94: R65         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     75K 
                LONG-TERM INVESTMENTS - Investment in Precision                  
                Autoimmune Therapeutics Co Ltd (Pat) (Details)                   
95: R66         Inventories (Details)                               HTML     43K 
96: R67         Leases - (Details)                                  HTML     57K 
97: R68         Leases - Right of Use Assets and Liabilities        HTML     51K 
                (Details)                                                        
98: R69         LEASES - Supplemental Cash Flow (Details)           HTML     45K 
99: R70         LEASES - Future Undiscounted Cash Flows (Details)   HTML     61K 
100: R71         PROPERTY, PLANT AND EQUIPMENT - Narratives          HTML     50K  
                (Details)                                                        
101: R72         PROPERTY, PLANT AND EQUIPMENT - By type (Details)   HTML     55K  
102: R73         INTANGIBLE ASSETS - Narratives (Details)            HTML     72K  
103: R74         INTANGIBLE ASSETS - Net Definite-lived Intangible   HTML     59K  
                Assets (Details)                                                 
104: R75         INTANGIBLE ASSETS - Intangible Assets Rollforward   HTML     50K  
                (Details)                                                        
105: R76         INTANGIBLE ASSETS - Expected Future Amortization    HTML     52K  
                Expense (Details)                                                
106: R77         Accrued and Other Current Liabilities, and Other    HTML     73K  
                Liabilities (Details)                                            
107: R78         Short Term Borrowings (Details)                     HTML     63K  
108: R79         Notes Payable (Details)                             HTML     50K  
109: R80         Grants (Details)                                    HTML     51K  
110: R81         Redeemable Noncontrolling Interest and Long Term    HTML     96K  
                Borrowing (Details)                                              
111: R82         Redeemable Noncontrolling Interest and Long Term    HTML     51K  
                Borrowing - Changes in Redeemable Noncontrolling                 
                Interest (Details)                                               
112: R83         Shareholders' Equity (Details)                      HTML     83K  
113: R84         Shareholders' Equity - Warrants Activity (Details)  HTML     52K  
114: R85         Costs of Revenues (Details)                         HTML     42K  
115: R86         Net Loss Per Share (Details)                        HTML     43K  
116: R87         Net Loss Per Share - Basic and diluted net loss     HTML     70K  
                per share computation (Details)                                  
117: R88         Employee Benefit Plan (Details)                     HTML     44K  
118: R89         SHARE-BASED COMPENSATION - Compensation Expense     HTML     55K  
                (Details)                                                        
119: R90         SHARE-BASED COMPENSATION - Weighted-Average         HTML     55K  
                Assumptions (Details)                                            
120: R91         SHARE-BASED COMPENSATION - Options Outstanding      HTML     95K  
                (Details)                                                        
121: R92         SHARE-BASED COMPENSATION - Stock Option             HTML     70K  
                Outstanding (Details)                                            
122: R93         Share-Based Compensation (Details)                  HTML     86K  
123: R94         INCOME TAXES - Loss Before Income Taxes (Details)   HTML     50K  
124: R95         INCOME TAXES - Deferred Income Tax Assets And       HTML     72K  
                Liabilities (Details)                                            
125: R96         INCOME TAXES - Reconciliation Of The Provision For  HTML     65K  
                Income Taxes (Details)                                           
126: R97         INCOME TAXES - Valuation allowance (Details)        HTML     47K  
127: R98         INCOME TAXES - Gross Unrecognized Tax Benefits      HTML     45K  
                (Details)                                                        
128: R99         Income Taxes (Details)                              HTML     77K  
129: R100        FAIR VALUE MEASUREMENTS - Financial and             HTML     67K  
                Non-Financial Assets and Liabilities (Details)                   
130: R101        FAIR VALUE MEASUREMENTS - Quantitative Information  HTML     50K  
                about Level 3 Fair Value Measurements (Details)                  
131: R102        Fair Value Measurements (Details)                   HTML     62K  
132: R103        Related Party Transactions (Details)                HTML     83K  
133: R104        Commitments and Contingencies (Details)             HTML     58K  
134: R105        Restricted Net Assets (Details)                     HTML     40K  
135: R106        CONDENSED FINANCIAL INFORMATION OF REGISTRANT -     HTML    150K  
                Condensed Balance Sheets (Details)                               
136: R107        CONDENSED FINANCIAL INFORMATION OF REGISTRANT -     HTML    108K  
                Condensed Statements of Operations and                           
                Comprehensive Loss (Details)                                     
137: R108        CONDENSED FINANCIAL INFORMATION OF REGISTRANT -     HTML    108K  
                Condensed Statements of Cash Flows (Details)                     
139: XML         IDEA XML File -- Filing Summary                      XML    243K  
142: XML         XBRL Instance -- casi-20231231x20f_htm               XML   3.57M  
138: EXCEL       IDEA Workbook of Financial Report Info              XLSX    249K  
26: EX-101.CAL  XBRL Calculations -- casi-20231231_cal               XML    267K 
27: EX-101.DEF  XBRL Definitions -- casi-20231231_def                XML   1.32M 
28: EX-101.LAB  XBRL Labels -- casi-20231231_lab                     XML   1.83M 
29: EX-101.PRE  XBRL Presentations -- casi-20231231_pre              XML   1.74M 
25: EX-101.SCH  XBRL Schema -- casi-20231231                         XSD    324K 
140: JSON        XBRL Instance as JSON Data -- MetaLinks              668±  1.06M  
141: ZIP         XBRL Zipped Folder -- 0001558370-24-004190-xbrl      Zip   1.32M  


‘R31’   —   Summary of Significant Accounting Policies (Policies)


This is SEC-created IDEA Financial Report Info.  [ Alternative Formats ]



 
v3.24.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
12 Months Ended
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”). The Company’s Redomicile Merger was accounted for as a legal reorganization with no change in ultimate ownership interest immediately before and after the transaction. Accordingly, all assets and liabilities will be recorded at historical cost as an exchange between entities under common control, and the consolidated assets and liabilities of CASI Cayman will be the same as those of the Company immediately prior to the Redomicile Merger.

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 property, plant and equipment, right of use assets, intangible assets and long-term investments, valuation allowance for deferred tax assets, share-based arrangements and fair value of investments. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements.

Consolidation

Consolidation

The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries, in which CASI, directly or indirectly, has a controlling financial interest.

These subsidiaries include CASI China, CASI Wuxi, CASI Biopharmaceuticals, CASI Pharmaceuticals (Hainan) Co., Ltd. (“CASI Hainan”), ZhongBio (Beijing) Tech Co. Ltd. (“ZhongBio”) and CASI Pharmaceuticals Co., Ltd., a subsidiary incorporated in Hong Kong in 2023. ZhongBio was dissolved in January 2023, and CASI Hainan was dissolved in May 2023.

All inter-company balances and transactions have been eliminated in consolidation. The Company currently operates in one operating segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market.

Foreign Currency Translation and Transactions

Foreign Currency Translation and Transactions

The accompanying consolidated financial statements of the Company are reported in US dollars. The financial position and results of operations of the Company’s subsidiaries in the PRC are measured using the Renminbi (RMB), which is the local and functional currency of these entities. Assets and liabilities of the Company’s PRC subsidiaries are translated into US$ using the exchange rates in effect at the consolidated balance sheet date. The revenues and expenses of these entities are translated into US$ at the weighted average exchange rates for the period. The resulting translation gains (losses) are recorded in accumulated other comprehensive loss as a component of shareholders’ equity.

Transactions denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Net gains or losses resulting from foreign currency denominated transactions are recorded in foreign exchange gain (losses) in the consolidated statements of operations and comprehensive loss.

Segment Reporting

Segment Reporting

In accordance with ASC 280, Segment Reporting, the Company’s chief operating decision maker, the Chief Executive Officer, reviews the consolidated results when making decisions about allocating resources and assessing performance of the Company as a whole and hence, the Company has only one reportable segment: pharmaceutical products.

Revenue Recognition

Revenue Recognition

Product sales and sublicensing revenue recognized in the consolidated statements of operations and comprehensive loss are considered revenue from contracts with customers and, accordingly, the Company recognizes revenue using the following steps:

Identification of the contract, or contracts, with a customer;
Identification of the performance obligations in the contract;
Determination of the transaction price, including the identification and estimation of variable consideration;
Allocation of the transaction price to the performance obligations in the contract; and
Recognition of revenue when the Company satisfies a performance obligation.

The Company recognizes revenue on sales of EVOMELA® 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 Company recognizes accounts receivable when it recognizes revenues as its right to consideration is unconditional and only the passage of time is required before payment of that consideration is due.

The costs of assurance type warranties that provide the customer the right to exchange purchased product that does not meet appropriate quality standards are recognized when they are probable and are reasonably estimable. There was no product exchange during the years ended December 31, 2023, 2022 and 2021. As of December 31, 2023, 2022 and 2021, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of December 31, 2023 and 2022.

The Company recognizes revenue from non-refundable upfront payments and milestone payments on sublicense arrangements when the license that represents a functional intellectual property is transferred to the customer and the customer is able to use and benefit from the license. When certain upfront payments or milestone payments is considered as constrained variable considerations as they are contingent upon achievement of certain milestones that are not within the control of the Company, they are excluded from the transaction price before the constraints are resolved.

Concentrations Risks

Concentrations Risks

Cash Concentration Risk

The Company maintains its U.S., Hong Kong dollar 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, Acrotech, for its EVOMELA® and FOLOTYN® products. The Company’s ability to select other providers of EVOMELA® and FOLOTYN® is limited by FDA regulations.

Geographic Concentration Risk

The Company revenue is solely generated in mainland China.

Accounts Receivable and Credit Concentration

CRPCGIT is the sole customer of the Company's EVOMELA® product sales in China. All consolidated product sales for the years ended December 31, 2023, 2022 and 2021 were generated from sales to CRPCGIT in China, and all the Company’s accounts receivable balance as of December 31, 2023 and 2022 were due from CRPCGIT.

The Company extends credit to CRPCGIT on an unsecured basis and does not believe there is significant credit risk.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include:

Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities.

Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

See Note 3 and Note 19 for additional fair value disclosures.

Cash and Cash Equivalents

Cash and Cash Equivalents

Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days that are readily convertible to known amounts of cash. As of December 31, 2023, the Company had $2.1 million cash and cash equivalents held in financial institutions in the mainland China, $0.3 million held in financial institutions in Hong Kong, and $14.7 million held in financial institutions in the US.

Short Term Investments

Short Term Investments

The Company’s short term investments represent investments in financial instruments with a variable interest rate and term deposits with original maturities of more than 90 days that are readily convertible to known amounts of cash. The Company elected the fair value method at the date of initial recognition, and carried these short term investments subsequently at fair value. Changes in fair values are reflected in the consolidated statements of comprehensive income. As of December 31, 2023, the Company held its short term investments solely in financial institutions in mainland China. The aggregate cost and fair value are as follows:

December 31

(In thousands)

    

2023

    

2022

Aggregate cost basis

$

11,698

    

$

1,462

Gross unrealized gain

 

313

 

Aggregate fair value

$

12,011

$

1,462

Allowance for Credit Losses

Allowance for Credit Losses

The Company adopted Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments for the year beginning January 1, 2023.

The Company estimates the allowance for credit losses based on the historical loss rates from historical observation period, and adjusted to reflect the effects of current and future economic conditions over reasonable and supportable forecast period.

Inventories

Inventories

Inventories consist of EVOMELA® and FOLOTYN® finished goods 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.

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.

Property, Plant and Equipment

Property, Plant and Equipment

Property, plant and equipment are stated at cost, less accumulated depreciation and impairment, if any.

Costs incurred in the construction of property, plant and equipment, including down payments and progress payments, are initially capitalized as construction-in-progress and transferred into their respective asset categories when the assets are ready for their intended use, at which time depreciation commences. Office equipment and furniture are depreciated over their estimated useful lives of 3 to 5 years. Machinery and lab equipment are depreciated over their estimated useful lives of 5 to 10 years. Leasehold improvements are amortized over the shorter of their useful lives or the lease term. Depreciation and amortization expense are determined on a straight-line basis. As of December 31, 2023, substantially all of the Company’s property, plant and equipment are located in the mainland China.

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®.

Investments

Investments

The Company’s investments mainly consist of investments in equity securities with readily determinable fair value, equity securities without readily determinable fair value, investments measured using fair value option, and investment of equity method.

Investment in equity securities with readily determinable fair value are measured at fair values, and any changes in fair value are recognized in earnings. Where the fair value of an investment in equity securities is not readily determinable, the Company recognizes such investment in long-term investments, and uses the measurement alternative of cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.

For equity investments measured at fair value with changes in fair value recorded in earnings, the Company does not assess whether those securities are impaired. For equity investments without readily determinable fair value, at each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. Impairment indicators that the Company considers include, but are not limited to, (i) the deterioration of earnings performance, credit rating, asset quality, or business prospects of the investee, (ii) a significant adverse change in the regulatory, economic, or technological environment of the investee, (iii) a significant adverse change in the general market condition of either the geographic area or the industry in which the investee operates. If a qualitative assessment indicates that the investment is impaired, the Company has to estimate the investment’s fair value and if the fair value is less than the investment’s carrying value, the Company recognizes an impairment loss in non-operating expenses equal to the difference between the carrying value and fair value.

Dividend income is recognized in other income when earned.

The Company elected to use fair value option to account for its investment in Cleave (see Note 3) as permitted under Accounting Standards Codification (“ASC”) 825, Financial Instruments (“ASC 825”), which then refers to ASC 820, Fair Value Measurement (“ASC 820”) to provide the fair value framework for valuing such investments. In accordance with ASC 820, the Company records such investment at fair value, with changes in fair value recorded in change in fair value of investments in the consolidated statements of operations and comprehensive loss.

For investments in common stock or in-substance common stock of entities over which the Company can exercise significant influence but does not own a majority equity interest or control, the equity method is applied, and the Company adjusts the carrying amount of an investment and recognizes investment income or loss for the Company’s share of the earnings or loss of the investee after the date of investment.

Leases

Leases

At contract inception, the Company determines whether an arrangement is or contains a lease and whether the lease should be classified as an operating or a financing lease. A contract is or contains a lease if the contract conveys the right to control the use of the identified asset for a period of time in exchange for consideration. Control is determined based on the right to obtain substantially all of the economic benefits from use of the identified asset and the right to direct the use of the identified asset. Right of use (“ROU”) assets

for operating leases represent the right to use an underlying asset for the lease term, and operating lease liabilities represent the obligation to make lease payments.

ROU assets and lease liabilities are recognized upon lease commencement for operating leases based on the present value of lease payments over the lease term. As the rate implicit in the lease cannot be readily determined, the Company uses incremental borrowing rate at the lease commencement date in determining the imputed interest and present value of lease payments. The incremental borrowing rate was determined based on the rate of interest that the Company would have to borrow an amount equal to the lease payments on a collateralized basis over a similar term. The incremental borrowing rate is primarily influenced by the risk-free interest rate of China and the US, the Company’s credit rating and lease term, and is updated for measurement of new lease liabilities.

For operating leases, the Company recognizes a single lease cost on a straight-line basis over the remaining lease term.

The Company has elected not to recognize ROU assets or lease liabilities for leases with an initial term of 12 months or less; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. In addition, the Company has elected not to separate non-lease components (e.g., common area maintenance fees) from the lease components.

Land use rights acquired are recognized in right-of-use assets if they meet the definition of lease.

As of December 31, 2023, all of the Company’s ROU assets are located in the mainland China.

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

Long-lived assets, including property, plant and equipment, right of use (“ROU”) assets and intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances (“triggering events”) indicate that the carrying amount of an asset or asset group may not be recoverable. The Company identifies triggering events and performs impairment testing at asset group level which represents the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities. As of December 31, 2023, the Company’s asset groups consist of manufacturing asset group and non-manufacturing asset group.

Triggering events include, but are not limited to, significant decrease of market price of the asset group, significant adverse change of an asset group’s use or physical condition, significant adverse changes in the industry conditions, significantly excessive accumulated cost compared with original expectation, expected continuing losses or negative cash flow associated with the use of the asset group, and expected significant early disposal of asset group.

If circumstances require an 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.

Acquired In-Process Research and Development Expense

Acquired In-Process Research and Development Expense

The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under U.S. GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use.

The Company also pays contingent development milestone payments in accordance with agreements (see Note 1). The Company recognizes development milestone payments as acquired in-process research and development expenses when the milestones are reached.

Share-Based Compensation

Share-Based Compensation

The Company records compensation expense associated with service and performance-based share options in accordance with provisions of authoritative guidance. The estimated fair value of solely service-based awards that have a graded vesting schedule is measured on the grant date and is generally recognized on a straight-line basis over the requisite service period for the entire award, provided that the cumulative amount of compensation cost recognized at any date at least equals the portion of the grant date fair value of such award that is vested at that date. 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 at tranche-by-tranche basis. If the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation expense relating to those awards are reversed as occurred.

When there is a modification of an award, the accounting for the modification depends on the likelihood, at the date of the modification that the original award would have vested under its original terms. If, at the date of the modification, it is probable that the original award would have vested under its original terms, the cumulative compensation cost to be recognized equals the grant-date fair value of the original award plus the incremental value of the award given in the modification. In calculating the incremental compensation cost of a modification, the fair value of the modified award is compared to the fair value of the original award measured immediately before its terms or conditions are modified. The Company recognizes share-based compensation over the vesting periods of the modified awards, which comprises, (i) the amortization of the incremental portion of share-based compensation over the remaining vesting term and (ii) any unrecognized compensation cost of the original award over the original term. If, at the date of the modification, it is not probable that the original award would have vested under its original terms, the fair value of the modified awards on the modification date will be used for recognizing compensation cost when it becomes probable.

Grant date and modification date fair value was determined using an option pricing model which is affected by the fair value of underlying ordinary shares as well as assumptions regarding a number of complex and subjective variables, such as expected volatility, expected term of options, risk-free rate, and expected dividend yield.

Government Grants

Government Grants

Government grants are recognized when there is reasonable assurance that the Company will comply with required conditions and the grants will be received. Government grants related to assets are presented as deferred income that is recognized on a systematic basis over the useful life of the asset.

Income Taxes

Income Taxes

Income tax expense is recognized using the asset and liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities and operating loss and tax credit carryforwards as measured by the enacted tax rates that will be in effect when these differences reverse. A valuation allowance is provided to reduce the amount of deferred income tax assets if it is considered more likely than not that some portion or all of the deferred income tax assets will not be realized.

The Company recognizes in its consolidated financial statements the impact of a tax position if a tax return position or future tax position is “more likely-than-not” to be sustained upon examination, based on the technical merits of the position. Tax positions that meet the “more-likely-than-not” recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. The Company recognizes interest and penalties related to uncertain tax positions, if any, in income tax expense.

Net Loss Per Share

Net Loss Per Share

Net loss per share (basic and diluted) was computed by dividing net loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding.

New Accounting Pronouncements

New Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments to the initial guidance including ASU No. 2018-19, ASU No. 2019-04, and ASU No. 2019-05 (collectively, “Topic 326”). Topic 326 requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for public business entities, excluding entities eligible to be smaller reporting companies for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, this standard is effective for annual and interim periods beginning after December 15, 2022 and early adoption is permitted for annual and interim periods beginning after December 15, 2018. As CASI Delaware was a smaller reporting company and was not required to adopt it for annual and interim periods before December 15, 2022, the Company adopted ASU 2016-13 and subsequent amendments for the year beginning January 1, 2023. The adoption of ASU 2016-13 and subsequent amendments does not have a material impact on the Company’s consolidated financial statements.

In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions. The Company adopted ASU 2021-10 for the annual period from January 1, 2022 and retrospectively disclosed such transactions in Note 11.

In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, which aims to (1) clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. The amendments in this Update clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. The amendments also clarify that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction. The amendments in this Update also require the following disclosures for equity securities subject to contractual sale restrictions: (1) the fair value of equity securities subject to contractual sale restrictions reflected in the balance sheet, (2) the nature and remaining duration of the restriction(s) and (3) the circumstances that could cause a lapse in the restriction(s). The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2023. The Company plans to adopt ASU 2022-03 for the year beginning January 1, 2024 and does not believe there is material impact to the consolidated financial statements other than disclosures required above.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The amendments in ASU 2023-07 improve reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. The amendments introduce a new requirement to disclose significant segment expenses regularly provided to the chief operating decision maker (CODM), extends certain annual disclosures to interim periods, clarifies single reportable segment entities must apply ASC 280 in its entirety, permits more than one measure of segment profit or loss to be reported under certain conditions, and requires disclosure of the title and position of the CODM. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company will adopt ASU 2023-07 for the year beginning January 1, 2024 and does not believe there is material impact to the consolidated financial statements other than disclosures for single reportable segment entities required above.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in ASU 2023-09 address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This ASU also includes certain other amendments to improve the effectiveness of income tax disclosures. For public business entities, the amendments in this ASU are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The amendments in this ASU should be applied on a prospective basis. Retrospective application is permitted. The Company plans to adopt ASU 2023-09 for the year beginning January 1, 2025 is currently evaluating the impact of this new guidance 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.


Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘20-F’ Filing    Date    Other Filings
1/1/25
12/15/24
Filed on:3/28/24
1/1/24
For Period end:12/31/23
12/15/236-K
1/1/23
12/31/2220-F
12/15/22
1/1/22
12/31/21
12/15/21
12/15/19
12/15/18
 List all Filings 


1 Subsequent Filing that References this Filing

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 5/03/24  CASI Pharmaceuticals, Inc.        F-3                    4:521K


14 Previous Filings that this Filing References

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 5/23/23  CASI Pharmaceuticals, Inc.        S-8 POS     5/23/23    3:156K                                   Toppan Merrill/FA
 4/26/23  CASI Pharmaceuticals, Inc.        20-F       12/31/22  129:16M                                    Toppan Merrill Bridge/FA
 1/31/23  CASI Pharmaceuticals, Inc.        F-4                   22:2.7M                                   Toppan Merrill/FA
11/14/22  CASI Pharmaceuticals, Inc. (DE)   10-Q        9/30/22   74:7.2M                                   Toppan Merrill Bridge/FA
 8/12/22  CASI Pharmaceuticals, Inc. (DE)   10-Q        6/30/22   76:8.1M                                   Toppan Merrill Bridge/FA
12/10/21  CASI Pharmaceuticals, Inc. (DE)   8-K:5,9    12/08/21   12:219K                                   Toppan Merrill/FA
 3/30/21  CASI Pharmaceuticals, Inc. (DE)   10-K       12/31/20  109:13M                                    Toppan Merrill Bridge/FA
11/09/20  CASI Pharmaceuticals, Inc. (DE)   10-Q        9/30/20   91:7.2M                                   Toppan Merrill/FA
 3/16/20  CASI Pharmaceuticals, Inc. (DE)   10-K       12/31/19   98:6.9M                                   Toppan Merrill/FA
 8/09/19  CASI Pharmaceuticals, Inc. (DE)   10-Q        6/30/19   75:16M                                    Toppan Merrill/FA
 5/15/19  CASI Pharmaceuticals, Inc. (DE)   10-Q        3/31/19   78:5.6M                                   Toppan Merrill/FA
 3/29/19  CASI Pharmaceuticals, Inc. (DE)   10-K       12/31/18   91:7.7M                                   Toppan Merrill/FA
 8/14/17  CASI Pharmaceuticals, Inc. (DE)   10-Q        6/30/17   40:1.7M                                   Toppan Merrill/FA
 4/17/07  CASI Pharmaceuticals, Inc.        8-K:5,8,9   4/16/07    9:152K                                   Bowne - DC/FA
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