Note 10 — Segment Reporting

 

As noted above, the Company’s primary focus is the commercialization of our lead product, DefenCath indicated to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a CVC.

 

The Company has determined that it currently operates in a single segment - Drug Product, located in a single geographic location – the United States. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively.

 

The Company’s Chief Executive Officer is the Chief Operating Decision Maker (“CODM”). The CODM manages the Company’s business activities as a single operating and reportable segment. The CODM uses consolidated profit and loss to evaluate and measure performance against progress in its commercialization efforts and clinical trials. The following table sets forth significant segment expenses.

 

   December 31, 
  2024   2023 
Research and development:        
Employee expense  $2,454,650   $7,210,785 
Other research and development   1,487,620    5,944,341 
Total research and development   3,942,270    13,155,125 
Selling and marketing          
Employee expense  $13,493,663   $2,552,846 
Other selling and marketing   15,242,942    15,562,467 
Total selling and marketing expense   28,736,605    18,115,313 
General and administrative          
Employee expense  $18,321,459   $10,961,034 
Other general and administrative   11,637,691    6,726,316 
Total general and administrative expense   29,959,150    17,687,350 
Total operating expenses  $62,638,025   $48,957,788 

About Segments Disclosures

Segment disclosures break a company into its reportable operating units, revealing revenue, profit, and asset allocation that consolidated financial statements obscure. Under ASC 280, segments must match how the chief operating decision maker views the business, providing a window into internal management structure and resource allocation priorities.

Key signals: compare segment margins to identify which units drive profitability and which destroy value. Watch for changes in the number of reportable segments — segment aggregation or disaggregation often coincides with strategic shifts or attempts to obscure declining performance. Intersegment elimination patterns reveal internal pricing practices. The reconciliation between segment totals and consolidated figures exposes corporate overhead allocation and unallocated items. Geographic revenue concentration highlights regulatory and currency exposure. Compare segment-level capital expenditure against segment revenue to assess where management is investing for future growth versus harvesting existing assets.