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Segment Reporting
6 Months Ended
Jun. 30, 2025
Segment Reporting [Abstract]  
Segment Reporting
14.
Segment Reporting

The Company views its operations and manages its business in one operating and one reportable segment, which includes all activities related to the identification, development and commercialization of medicines for childhood and adult diseases with equal intensity. The determination of a single operating segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker, or CODM. The Company’s CODM is its Chief Executive Officer, who reviews and evaluates net loss for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. Our CODM does not evaluate the operating segment using asset or liability information. The operating segment derives all net product revenues from the sales of OJEMDA in the United States through contractual arrangements with its specialty pharmacy and specialty distributor customers. All the Company’s assets are located in the United States.

In addition to the significant expense categories included within net loss presented on the Company's condensed statements of operations, see below for disaggregated amounts that comprise research and development expenses:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

 

(in thousands)

 

External costs:

 

 

 

 

 

 

 

 

 

 

 

 

Third-party CRO, CMO and other third-party clinical trial costs (1)

 

$

22,087

 

 

$

22,547

 

 

$

42,908

 

 

$

42,093

 

License agreement related payments

 

 

 

 

 

55,000

 

 

 

4,000

 

 

 

60,000

 

Other research and development costs

 

 

2,001

 

 

 

2,346

 

 

 

4,021

 

 

 

4,513

 

Internal costs:

 

 

 

 

 

 

 

 

 

 

 

 

Employee related expenses

 

 

12,061

 

 

 

12,213

 

 

 

24,839

 

 

 

25,710

 

Total research and development expenses

 

$

36,149

 

 

$

92,106

 

 

$

75,768

 

 

$

132,316

 

(1) Costs incurred under agreements with third-party CROs, CMOs, and other third parties that conduct clinical activities on the Company's behalf.