Shield Therapeutics (STX) H2 2025 earnings summary

Executive summary

• Achieved record revenues of approximately $50M in FY25, with ACCRUFER® U.S. revenues up 56% year-over-year and prescriptions rising to c.199,000, supported by a 21% increase in net selling price to $223 per prescription.

• ACCRUFER® became the #1 branded prescription oral iron in the U.S. ID/IDA market, driven by a restructured sales force and enhanced digital marketing.

• Cash flow positivity was reached in Q4 2025, providing strategic flexibility for 2026.

• Regulatory milestones included FDA and EMA approval for pediatric indications and launches/approvals in Canada, Korea, and progress in China and Japan.

Financial highlights

• Total revenue for 2025 was $49.7M, up from $32.2M in 2024; U.S. net product revenue was $45.8M (2024: $29.3M).

• Royalty and milestone revenues totaled $3.9M, including $2.3M from FeRACCRU sales in Europe.

• Cost of sales increased to $26.7M (2024: $17.3M), reflecting higher revenue share and manufacturing costs.

• Selling, general, and administrative expenses decreased to $31.6M (2024: $36.0M) due to sales force restructuring.

• Research and development spend was $1.8M (2024: $4.3M), mainly for pediatric studies.

• Loss after tax narrowed to $17.7M from $27.2M in 2024.

• Cash at year-end was $11.6M, up from $6.5M in 2024.

Outlook and guidance

• Anticipates strong growth in 2026, driven by expanded sales force, marketing, and improved patient access.

• Strategic priorities: grow ACCRUFER® net revenues, diversify revenue beyond adult ID/IDA in the U.S., and achieve sustained profitability.

• International expansion to continue, with launches in Korea, regulatory progress in China, and new indications in Japan.