Egetis Therapeutics (EGTX) Q4 2024 earnings summary

Executive summary

• Achieved full European approval for Emcitate, the first and only treatment for MCT8 deficiency, with Germany launch set for Q2 2025 and expansion to other EU4 countries planned.

• U.S. pivotal ReTRIACt study is progressing, supporting a planned NDA filing in 2025 and anticipated U.S. launch in 2026.

• Emcitate is prescribed to approximately 230 patients via Managed Access Programs in over 25 countries.

• Egetis is evaluating resistance to thyroid hormone beta (RTHβ) as the next indication for Emcitate, with plans for a Phase 2 study.

Financial highlights

• Full-year 2024 revenue was SEK 43.1 million, down from SEK 57.6 million year-over-year, mainly due to a one-time license income in 2023.

• Q4 2024 revenue was SEK 10.8 million, compared to SEK 32.6 million in Q4 2023, impacted by lumpy Managed Access Program income.

• Q4 2024 net loss was SEK 110.5 million, compared to SEK 86.3 million in Q4 2023, driven by increased commercial investments and non-cash items.

• Cash position at year-end 2024 was SEK 351 million, up from SEK 303 million, bolstered by a SEK 281 million net cash injection in Q4.

• Earnings per share for 2024 were SEK -1.1 (2023: -1.3), both before and after dilution.

Outlook and guidance

• Emcitate launch in Germany expected in Q2 2025, with other EU4 launches following as reimbursement is secured.

• U.S. NDA filing for Emcitate planned for 2025, with anticipated approval and launch in 2026.

• R&D costs expected to decline as ReTRIACt concludes, offset by increased commercial investments; overall OpEx to remain flat or moderately up in 2025.

• Ongoing dialogue with BlackRock regarding extension of Tranche B (EUR 15 million) loan facility.