Egetis Therapeutics (EGTX) Q3 2024 earnings summary

Executive summary

• EMA review of tiratricol (Emcitate) for MCT8 deficiency is progressing on schedule, with responses to 180-day questions due by November 12 and CHMP opinion expected late this year or early next.

• New survival data show tiratricol treatment reduces all-cause mortality risk by threefold in MCT8 deficiency, with over 220 patients treated via Managed Access Programs.

• The European Thyroid Association recommends tiratricol (Emcitate) as long-term therapy for all MCT8 deficiency patients, supporting future commercialization.

• Directed share issuances raised SEK 300 million, led by Frazier Life Sciences, strengthening the financial position.

• Submission of a U.S. patent application for tiratricol manufacturing processes, potentially extending exclusivity.

Financial highlights

• Q3 2024 revenue was SEK 9.4 million, down from SEK 12.2 million in Q3 2023, due to lumpy order patterns; nine-month revenue rose to SEK 35.3 million from SEK 25 million year-over-year.

• Q3 net loss after tax was SEK -86.2 million, unchanged from the prior year; nine-month net loss improved to SEK -233.1 million from SEK -240.7 million.

• Cash position at September end was SEK 129.9 million, up from SEK 85 million last year; post-period, SEK 282 million was received from share issuances.

• Operating expenses for Q3 2024 were SEK -86.6 million, down from SEK -96.1 million in Q3 2023; R&D expenses decreased to SEK -32.2 million from SEK -49.8 million.

• EPS for Q3 2024 was SEK -0.3 (Q3 2023: SEK -0.3); nine-month EPS improved to SEK -0.8 from SEK -1.0.

Outlook and guidance

• EMA approval process is progressing as planned, with no major surprises expected from the 180-day questions.

• Go-to-market strategy in Europe will focus first on Germany, France, Italy, and Spain, with initial sales expected in Germany.

• U.S. NDA submission timing will be updated after ReTriACt study recruitment closes; focus remains on completing the ReTRIACt study and preparing for European launch.

• Orphan premium pricing is expected in both Europe and the U.S., though lack of neurocognitive data may impact EU pricing.

• Recruitment for the ReTRIACt trial continues, with updates on topline results and NDA timing to follow closure.