Outlook Therapeutics, Inc. Segments Disclosure
14. Segment Information
Operating segments are components of an enterprise for which discrete financial information is available and reviewed by the chief operating decision maker (“CODM”) to allocate resources and assess performance. The Company has one reportable segment, which consists of the development and commercialization of ONS-5010/LYTENAVA™, an ophthalmic formulation of bevacizumab for the treatment of wet AMD. The Company’s CODM is its Chief Executive Officer, who evaluates and manages the business on a consolidated basis for purposes of resource allocation and performance assessment.
The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies. To date, the Company has generated insignificant product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations. The CODM uses budget versus forecasted expense and cash forecast models in making decisions. Such models are reviewed to assess the entity-wide operating results and performance, including how long cash is expected to be sufficient. The measure of segment assets is reported on the consolidated balance sheet as total assets.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended September 30, 2025 and 2024:
Year ended September 30, | ||||||
2025 | 2024 | |||||
Revenues, net | $ | 1,413,535 | $ | — | ||
Cost of revenues | 1,356,330 | — | ||||
Gross profit | 57,205 | — | ||||
Operating expenses: | ||||||
Research and development expenses | ||||||
ONS-5010/LYTENAVA development | 23,286,684 | 37,355,884 | ||||
Compensation and related benefits | 2,385,606 | 2,507,635 | ||||
Stock-based compensation | 379,604 | 800,956 | ||||
Other research and development | 1,128,746 | 1,098,572 | ||||
27,180,640 | 41,763,047 | |||||
Selling, general and administrative expenses | ||||||
Professional fees | 6,173,453 | 9,866,128 | ||||
Compensation and related benefits | 8,177,077 | 6,301,200 | ||||
Stock-based compensation | 8,480,292 | 4,584,168 | ||||
Europe launch expenses | 13,377,691 | 5,010,687 | ||||
Facilities, fees and other related costs | 3,729,718 | 4,178,005 | ||||
39,938,231 | 29,940,188 | |||||
Segment loss from operations | (67,061,666) | (71,703,235) | ||||
Other segment items (i) | 3,084,974 | (3,660,679) | ||||
Segment loss before income taxes | $ | (63,976,692) | $ | (75,363,914) | ||
| (i) | Other segment items included in segment loss includes loss on equity method investment, interest income, interest expense, loss from change in fair value of promissory notes, warrant related expenses, warrant inducement expenses, and gain from change in fair value of warrant liability. |
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.