Egetis Therapeutics (EGTX) Q4 2024 earnings summary

Executive summary

• Achieved full European Commission approval for Emcitate as the first and only treatment for MCT8 deficiency, marking a transition to a commercial-stage company, with Germany launch set for Q2 2025 and US NDA filing planned for 2025.

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

• The pivotal ReTRIACt study for US approval is progressing, with 19 patients enrolled and NDA submission targeted for 2025, US launch anticipated in 2026.

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

• 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 46.1 million, down from SEK 57.6 million in 2023, mainly due to absence of one-time license income; Q4 2024 revenue was SEK 10.8 million, compared to SEK 32.6 million in Q4 2023.

• 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, supported by a SEK 300 million oversubscribed directed share issue.

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

• Gross profit for FY 2024 was SEK 34.5 million, down from SEK 46.6 million in 2023.

Outlook and guidance

• Emcitate launch in Germany expected in Q2 2025, with phased expansion to other EU4 countries as reimbursement is secured.

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

• Key 2025 priorities include optimizing pricing and reimbursement, completing ReTRIACt, and preparing for US launch.

• Ongoing partnership discussions for MENAT region and Japan, with a development plan agreed with PMDA.

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