v3.26.1
SEGMENT INFORMATION
 6 Months Ended
Jun. 30, 2026
Segment Reporting [Abstract]  
SEGMENT INFORMATION

NOTE 14 – SEGMENT INFORMATION

 

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the 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 (loss) income, which is reported on the consolidated statements of operations and comprehensive (loss) as consolidated net (loss) income. 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 (loss) income 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 reviewed by the CODM (in thousands):

 

   2026   2025   2026   2025 
   For the three months ended June 30,   For the six months ended June 30, 
   2026   2025   2026   2025 
                 
Revenues:                    
Product revenue, net  $11,380   $—   $20,100   $— 
License and other revenues   —    400    —    400 
Total revenues   11,380    400    20,100    400 
                     
Cost of sales   4,177    —    6,873    — 
Royalties   —    100    —    100 
                     
Research and development costs:                    
Salaries & related costs   1,926    2,235    3,659    6,916 
Non-cash stock-based compensation   294    232    517    902 
Other research and development costs (a)   2,801    3,476    10,400    8,066 
Total research and development costs   5,021    5,943    14,576    15,884 
                     
Selling, general and administrative costs:                    
Salaries & related costs   7,254    7,456    15,599    11,109 
Non-cash stock-based compensation   3,075    2,598    5,809    4,629 
Commercial costs   2,015    2,290    3,817    3,497 
Other selling, general and administrative costs (b)   3,491    4,805    10,112    7,700 
Total selling, general and administrative costs   15,835    17,149    35,337    26,935 
                     
Other segment items, net (c)   (6,538)   131,625    (580)   139,323 
Net (loss) income  $(20,191)  $108,833   $(37,266)  $96,804 

 

(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 company reporting 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 liabilities, gain on sale of priority review voucher, other income and income tax (benefit) expense.