Shield Therapeutics (STX) Q4 2025 TU earnings summary

Executive summary

• Achieved cash flow positive status in Q4 2025, driven by strong US ACCRUFeR/ACCRUFERⓇ sales and effective cost management, marking a key milestone toward sustainability.

• ACCRUFeR/ACCRUFERⓇ became the number one branded prescription oral iron in the US ID/IDA market, with a highly tolerable proprietary formulation.

• Expanded global footprint with launches in Canada and regulatory progress in Korea, China, and pediatric populations.

• Focused on expanding market share through targeted marketing, salesforce optimization, and new indications, including pediatric and global launches.

• Actively seeking to add a second specialty product to the portfolio to leverage existing sales infrastructure.

Financial highlights

• Total 2025 revenues reached approximately $50 million, with $46 million from US ACCRUFeR/ACCRUFERⓇ sales, representing 56% year-over-year growth.

• Approximately 199,000–200,000 prescriptions dispensed in 2025, up 33% year-over-year.

• Net selling price per prescription increased 21% year-over-year to $223 in 2025.

• Q4 2025 US revenues were $13.5 million, with over 61,000 prescriptions and a net price of $222.

• Ended Q4 2025 with $11.6 million in cash and cash equivalents, generating $1 million in net cash (excluding debt refinancing).

Outlook and guidance

• Expects to remain cash flow positive and achieve EBIT/operating profit for full year 2026, supported by continued ACCRUFeR/ACCRUFERⓇ growth.

• Pricing expected to fluctuate between $222 and $240 per prescription in 2026, driven by channel mix and payer coverage.

• Targeting continued growth in ACCRUFeR/ACCRUFERⓇ prescriptions, especially in top US states and new specialties.

• Peak US sales target of $450 million remains achievable, supported by expansion into new indications and specialties.

• Two ACCRUFeR/ACCRUFERⓇ launches expected in 2026: South Korea and US pediatric (10+ years); regulatory filings planned for China and Europe (children).