CASI Pharmaceuticals, Inc. (DE) – ‘20-F’ for 12/31/22 – ‘EX-15.1’

On:  Wednesday, 4/26/23, at 8:25am ET   ·   For:  12/31/22   ·   Accession #:  1558370-23-6754   ·   File #:  0-20713

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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-2.2      Plan of Acquisition, Reorganization, Arrangement,   HTML     51K 
                Liquidation or Succession                                        
 3: EX-4.20     Instrument Defining the Rights of Security Holders  HTML     38K 
 4: EX-4.30     Instrument Defining the Rights of Security Holders  HTML    611K 
 5: EX-8.1      Opinion of Counsel re: Tax Matters                  HTML     34K 
 9: EX-13.1     Annual or Quarterly Report to Security Holders      HTML     37K 
10: EX-13.2     Annual or Quarterly Report to Security Holders      HTML     37K 
 6: EX-11.1     Statement re: the Computation of Earnings Per       HTML     63K 
                Share                                                            
 7: EX-12.1     Statement re: the Computation of Ratios             HTML     40K 
 8: EX-12.2     Statement re: the Computation of Ratios             HTML     40K 
11: EX-15.1     Letter re: Unaudited Interim Financial Info         HTML     34K 
17: R1          Document and Entity Information                     HTML    109K 
18: R2          Consolidated Balance Sheets                         HTML    139K 
19: R3          Consolidated Balance Sheets (Parenthetical)         HTML     48K 
20: R4          Consolidated Statements of Operations and           HTML    178K 
                Comprehensive Loss                                               
21: R5          Consolidated Statements of Stockholders' Equity     HTML     86K 
22: R6          Consolidated Statements of Cash Flows               HTML    178K 
23: R7          Description of Business                             HTML     74K 
24: R8          Summary of Significant Accounting Policies          HTML     77K 
25: R9          Investment in Equity Securities, at Fair Value and  HTML    206K 
                Long-Term Investments                                            
26: R10         Inventories                                         HTML     37K 
27: R11         Leases                                              HTML     81K 
28: R12         Property, Plant and Equipment                       HTML     56K 
29: R13         Intangible Assets                                   HTML    107K 
30: R14         Accrued and Other Current Liabilities, and Other    HTML     69K 
                Liabilities                                                      
31: R15         Bank Borrowings                                     HTML     39K 
32: R16         Notes Payable                                       HTML     42K 
33: R17         Grants                                              HTML     38K 
34: R18         Redeemable Noncontrolling Interest                  HTML     60K 
35: R19         Stockholders' Equity                                HTML     67K 
36: R20         Costs of Revenues                                   HTML     37K 
37: R21         Net Loss Per Share                                  HTML     62K 
38: R22         Employee Benefit Plan                               HTML     39K 
39: R23         Share-Based Compensation                            HTML    185K 
40: R24         Income Taxes                                        HTML    135K 
41: R25         Fair Value Measurements                             HTML    141K 
42: R26         Related Party Transactions                          HTML     43K 
43: R27         Commitments and Contingencies                       HTML     39K 
44: R28         Restricted Net Assets                               HTML     37K 
45: R29         Subsequent Events                                   HTML     38K 
46: R30         Condensed Financial Information of Registrant       HTML    245K 
47: R31         Summary of Significant Accounting Policies          HTML    136K 
                (Policies)                                                       
48: R32         Investment in Equity Securities, at Fair Value and  HTML    191K 
                Long-Term Investments (Tables)                                   
49: R33         Leases (Tables)                                     HTML     81K 
50: R34         Property, Plant and Equipment (Tables)              HTML     53K 
51: R35         Intangible Assets (Tables)                          HTML    108K 
52: R36         Accrued and Other Current Liabilities, and Other    HTML     68K 
                Liabilities (Tables)                                             
53: R37         Redeemable Noncontrolling Interest (Tables)         HTML     55K 
54: R38         Stockholders' Equity (Tables)                       HTML     52K 
55: R39         Net Loss Per Share (Tables)                         HTML     60K 
56: R40         Share-Based Compensation (Tables)                   HTML    185K 
57: R41         Income Taxes (Tables)                               HTML    134K 
58: R42         Fair Value Measurements (Tables)                    HTML    141K 
59: R43         Condensed Financial Information of Registrant       HTML    247K 
                (Tables)                                                         
60: R44         DESCRIPTION OF BUSINESS - Liquidity and Capital     HTML     46K 
                Resources (Details)                                              
61: R45         DESCRIPTION OF BUSINESS - License and Distribution  HTML     38K 
                Agreements (China Resources Pharmaceutical                       
                Commercial Group International Trading Co., Ltd.)                
                (Details)                                                        
62: R46         DESCRIPTION OF BUSINESS - License and Distribution  HTML     50K 
                Agreements (Precision Autoimmune Therapeutics Co.,               
                Ltd) (Details)                                                   
63: R47         DESCRIPTION OF BUSINESS - License and Distribution  HTML     44K 
                Agreements (Juventas Cell Therapy Ltd.) (Details)                
64: R48         DESCRIPTION OF BUSINESS - License and Distribution  HTML     67K 
                Agreements (BioInvent International AB) (Details)                
65: R49         DESCRIPTION OF BUSINESS - License and Distribution  HTML     50K 
                Agreements (Black Belt Therapeutics Limited)                     
                (Details)                                                        
66: R50         DESCRIPTION OF BUSINESS - License and Distribution  HTML     44K 
                Agreements (Cleave Therapeutics, Inc.) (Details)                 
67: R51         DESCRIPTION OF BUSINESS - License and Distribution  HTML     44K 
                Agreements (Pharmathen Global BV) (Details)                      
68: R52         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Basis  HTML     42K 
                of Presentation (Details)                                        
69: R53         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -        HTML     39K 
                Consolidation (Details)                                          
70: R54         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -        HTML     36K 
                Segment Reporting (Details)                                      
71: R55         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -        HTML     37K 
                Concentrations of Risk (Details)                                 
72: R56         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash   HTML     42K 
                and Cash Equivalents (Details)                                   
73: R57         Summary of Significant Accounting Policies - Ppe    HTML     41K 
                (Details)                                                        
74: R58         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     42K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-MaxCyte Inc. (Details)                 
75: R59         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     75K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-BioInvent International                
                AB (Details)                                                     
76: R60         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     49K 
                LONG-TERM INVESTMENTS - Summary of Investments                   
                (Details)                                                        
77: R61         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     69K 
                LONG-TERM INVESTMENTS - Summary of Long-term                     
                investments (Details)                                            
78: R62         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     52K 
                LONG-TERM INVESTMENTS - Investment in Precision                  
                Autoimmune Therapeutics Co Ltd (Pat) (Details)                   
79: R63         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     66K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-Juventas Cell Therapy                  
                Ltd. (Details)                                                   
80: R64         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     65K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-Alesta Therapeutics B.V.               
                (Details)                                                        
81: R65         INVESTMENT IN EQUITY SECURITIES, AT FAIR VALUE AND  HTML     49K 
                LONG-TERM INVESTMENTS - Investment in equity                     
                securities, at fair value-Cleave Therapeutics,                   
                Inc. (Details)                                                   
82: R66         Inventories (Details)                               HTML     39K 
83: R67         Leases - (Details)                                  HTML     53K 
84: R68         Leases - Right of Use Assets and Liabilities        HTML     47K 
                (Details)                                                        
85: R69         LEASES - Supplemental Cash Flow (Details)           HTML     39K 
86: R70         LEASES - Future Undiscounted Cash Flows (Details)   HTML     53K 
87: R71         Property, Plant and Equipment (Details)             HTML     44K 
88: R72         Property, Plant and Equipment - By type (Details)   HTML     50K 
89: R73         Intangible Assets (Details)                         HTML     64K 
90: R74         Intangible Assets - Net Definite-lived Intangible   HTML     52K 
                Assets (Details)                                                 
91: R75         INTANGIBLE ASSETS - Intangible Assets Rollforward   HTML     47K 
                (Details)                                                        
92: R76         INTANGIBLE ASSETS - Expected Future Amortization    HTML     48K 
                Expense (Details)                                                
93: R77         Accrued and Other Current Liabilities, and Other    HTML     68K 
                Liabilities (Details)                                            
94: R78         Bank Borrowings (Details)                           HTML     55K 
95: R79         Notes Payable (Details)                             HTML     51K 
96: R80         Grants (Details)                                    HTML     47K 
97: R81         Redeemable Noncontrolling Interest (Details)        HTML     55K 
98: R82         Redeemable Noncontrolling Interest - Changes in     HTML     45K 
                Redeemable Noncontrolling Interest (Details)                     
99: R83         Stockholders' Equity (Details)                      HTML     92K 
100: R84         Stockholders' Equity - Warrants Activity (Details)  HTML     57K  
101: R85         Costs of Revenues (Details)                         HTML     38K  
102: R86         Net Loss Per Share (Details)                        HTML     39K  
103: R87         Net Loss Per Share - Basic and diluted net loss     HTML     67K  
                per share computation (Details)                                  
104: R88         Employee Benefit Plan (Details)                     HTML     40K  
105: R89         SHARE-BASED COMPENSATION - Compensation Expense     HTML     44K  
                (Details)                                                        
106: R90         SHARE-BASED COMPENSATION - Weighted-Average         HTML     51K  
                Assumptions (Details)                                            
107: R91         SHARE-BASED COMPENSATION - Options Outstanding      HTML     84K  
                (Details)                                                        
108: R92         SHARE-BASED COMPENSATION - Stock Option             HTML     74K  
                Outstanding (Details)                                            
109: R93         Share-Based Compensation (Details)                  HTML     65K  
110: R94         INCOME TAXES - Loss Before Income Taxes (Details)   HTML     43K  
111: R95         INCOME TAXES - Deferred Income Tax Assets And       HTML     66K  
                Liabilities (Details)                                            
112: R96         INCOME TAXES - Reconciliation Of The Provision For  HTML     62K  
                Income Taxes (Details)                                           
113: R97         INCOME TAXES - Gross Unrecognized Tax Benefits      HTML     42K  
                (Details)                                                        
114: R98         Income Taxes (Details)                              HTML     50K  
115: R99         FAIR VALUE MEASUREMENTS - Financial and             HTML     62K  
                Non-Financial Assets and Liabilities (Details)                   
116: R100        FAIR VALUE MEASUREMENTS - Quantitative Information  HTML     46K  
                about Level 3 Fair Value Measurements (Details)                  
117: R101        Fair Value Measurements (Details)                   HTML     57K  
118: R102        Related Party Transactions (Details)                HTML     87K  
119: R103        Commitments and Contingencies (Details)             HTML     48K  
120: R104        Restricted Net Assets (Details)                     HTML     37K  
121: R105        Subsequent Event (Details)                          HTML     48K  
122: R106        CONDENSED FINANCIAL INFORMATION OF REGISTRANT -     HTML    143K  
                Condensed Balance Sheets (Details)                               
123: R107        CONDENSED FINANCIAL INFORMATION OF REGISTRANT -     HTML    124K  
                Condensed Statements of Operations and                           
                Comprehensive Loss (Details)                                     
124: R108        CONDENSED FINANCIAL INFORMATION OF REGISTRANT -     HTML    115K  
                Condensed Statements of Cash Flows (Details)                     
127: XML         IDEA XML File -- Filing Summary                      XML    243K  
125: XML         XBRL Instance -- casi-20221231x20f_htm               XML   3.69M  
126: EXCEL       IDEA Workbook of Financial Reports                  XLSX    240K  
13: EX-101.CAL  XBRL Calculations -- casi-20221231_cal               XML    252K 
14: EX-101.DEF  XBRL Definitions -- casi-20221231_def                XML   1.12M 
15: EX-101.LAB  XBRL Labels -- casi-20221231_lab                     XML   1.64M 
16: EX-101.PRE  XBRL Presentations -- casi-20221231_pre              XML   1.57M 
12: EX-101.SCH  XBRL Schema -- casi-20221231                         XSD    298K 
128: JSON        XBRL Instance as JSON Data -- MetaLinks              597±   967K  
129: ZIP         XBRL Zipped Folder -- 0001558370-23-006754-xbrl      Zip    806K  

‘EX-15.1’   —   Letter re: Unaudited Interim Financial Info

This Exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]

Dates Referenced Herein

This ‘20-F’ Filing		Date		Other Filings
Filed on:		4/26/23		None on these Dates
For Period end:		12/31/22
				List all Filings

15 Previous Filings that this Filing References

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

 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
 5/13/21  CASI Pharmaceuticals, Inc. (DE)   10-Q        3/31/21   83:7M                                     Toppan Merrill Bridge/FA
 5/10/21  CASI Pharmaceuticals, Inc. (DE)   DEF 14A     6/15/21    1:905K                                   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
 4/30/19  CASI Pharmaceuticals, Inc. (DE)   DEF 14A     6/20/19    1:699K                                   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