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10-K2026-03-30· doubao-seed-2-0-pro-260215

EMMA · Emmaus Life Sciences, Inc.

0001193125-26-132925

SEC filing

Summary

FY2025 delivered Emmaus’ first operating profit in recent years, but generic Endari® competition pressured revenue and widened net loss, with the NIT license as a core near-term catalyst.

Key takeaways

Full analysis

Generic Competition Pressures Topline While Margin Remains Resilient

For fiscal 2025, Emmaus recorded total revenue of $12.5M, a 25.2% year-over-year decline driven by the 2024 U.S. launch of a generic version of its core product Endari®. Gross profit fell 25.0% year-over-year to $11.6M, but gross margin held steady at 93.1% as cost of goods sold adjusted proportionally to lower sales volumes, reflecting stable production costs aligned with output levels.

Cost Restructuring Delivers Operating Profit Amid Widening Net Loss

NIT License Deal as Core Near-Term Strategic Catalyst

In December 2025, Emmaus entered into an exclusive license and distribution agreement for U.S. and Canadian Endari® rights with NeoImmuneTech (NIT), representing the company’s primary near-term strategic catalyst. The deal is set to become effective upon NIT securing required regulatory approvals by the October 1, 2026 deadline. Upon close, sales and marketing responsibilities for Endari® in the U.S. will transition to NIT, which management expects will drive further declines in U.S. selling expenses for Emmaus. There is no assurance the deal will close by the required deadline, and if it does not, Endari® rights will revert to Emmaus, requiring the company to rebuild its U.S. sales capacity to support the product.