Annual report [Section 13 and 15(d), not S-K Item 405]

SEGMENT INFORMATION

v3.26.1
SEGMENT INFORMATION
 12 Months Ended
Dec. 31, 2025
Segment Reporting [Abstract]  
SEGMENT INFORMATION

NOTE 17 – SEGMENT INFORMATION

 

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the Chief Operating Decision Maker (“CODM”), or decision-making group, in deciding how to allocate resources in assessing performance. The Company is a commercial-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases and has one reportable segment. The Company’s CODM is the chief executive officer.

 

The accounting policies of the commercial-stage biopharmaceutical segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the commercial-stage biopharmaceutical segment based on net income (loss), which is reported on the consolidated statements of operations and comprehensive income (loss) as consolidated net income (loss). The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. Expenditures for additions to long-lived assets, which include purchases of property and equipment, are included in total consolidated assets reviewed by the chief operating decision maker and are reported on the consolidated statements of cash flows.

 

 

To date, the Company has generated limited product revenue. The Company will continue to incur significant expenses and operating losses until ZEVASKYN® can provide sufficient revenue for the Company to be profitable. As such, the CODM uses cash forecast models in deciding how to invest into the commercial-stage biopharmaceutical segment. Such cash forecast models are reviewed to make decisions about allocating resources and assessing the entity-wide operating results and performance. Net income (loss) is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used to make decisions about allocating resources, assessing the performance of the segment and in establishing management’s compensation, along with cash forecast models.

 

The table below summarizes the significant expense categories regularly provided to the CODM for the years ended December 31, 2025, and 2024:

 

    2025     2024  
    For the year ended December 31,  
    2025     2024  
             
Revenues:                
Product revenue, net   $ 2,420     $ —  
License and other revenues     3,400       —  
Total revenues     5,820       —  
                 
Cost of sales     1,532       —  
Royalties     1,893       —  
                 
Research and development costs:                
Salaries & related costs     10,247       15,345  
Non-cash stock-based compensation     1,355       1,561  
Other research and development costs (a)     15,210       17,454  
Total research and development costs     26,812       34,360  
                 
Selling, general and administrative costs:                
Salaries & related costs     24,978       10,729  
Non-cash stock-based compensation     9,424       5,067  
Commercial costs     7,159       4,818  
Other selling, general and administrative costs (b)     23,470       9,237  
Total selling, general and administrative costs     65,031       29,851  
                 
Other segment items, net (c)     160,631       477  
Net income (loss)   $ 71,183     $ (63,734 )

 

(a) Other research and development costs include, but are not limited to preclinical lab supplies, preclinical and development costs, clinical trial costs, preclinical manufacturing and manufacturing facility costs, costs associated with preclinical regulatory approvals, preclinical depreciation on lab supplies and manufacturing facilities, and preclinical consultant-related expenses.
(b) Other selling, general and administrative costs primarily consist of office facility costs, public reporting company related costs, professional fees (e.g., legal expenses), regulatory costs, production costs not attributable to cost of sales and other general operating expenses not otherwise included in research and development expenses.
(c) Other segment items include interest income, interest expense, change in fair value of warrant and derivative liabilities, gain on sale of priority review voucher, other income, net and income tax (benefit) expense.