Egetis Therapeutics (EGTX) Corporate presentation summary

Strategic highlights and product development

• Emcitate (tiratricol) launched in Germany in May 2025 and rolling U.S. NDA completed in January 2026.

• Emcitate is the first and only approved treatment for MCT8 deficiency in the EU, with anticipated FDA decision in September 2026.

• Strong regulatory status: Breakthrough Therapy and Orphan Drug Designations, with market exclusivity of 10 years in EU and 7 years in US.

• Partnerships established for Japan, Türkiye, Central/Eastern Europe, and the Gulf region to optimize global access.

• Expansion potential into Resistance to Thyroid Hormone Type Beta (RTH-β), with orphan drug designation for this indication.

Clinical efficacy and patient impact

• Emcitate demonstrated significant and durable reduction of T3 levels, normalization of thyrotoxicosis, and improved cardiovascular health and bodyweight in MCT8 deficiency patients.

• Real-world evidence shows a threefold reduction in mortality risk for patients treated with tiratricol.

• European Thyroid Association recommends Emcitate as long-term therapy for all MCT8 deficiency patients.

• Patient-centered outcomes include improved interaction, alertness, motor skills, and reduced sweating.

• Safety profile is benign, with benefits maintained or improving over up to six years.

Commercial execution and market access

• 2025 revenue reached 62.4 MSEK, up 40% year-over-year; Q4 revenue up 74% year-over-year.

• Phased EU launch began in Germany, with pricing and reimbursement processes advancing in major markets.

• U.S. launch preparations include deep engagement in referral centers, expanded access programs, and payer strategy validation.

• Lean, agile commercial team with global experience and strong KOL support.

• Priority Review Voucher upon U.S. approval could yield significant financial upside.