Egetis Therapeutics (EGTX) Q3 2024 earnings summary

Executive summary

• Achieved key milestones including progress on EU marketing authorization for Emcitate (tiratricol), submission of a U.S. patent application for tiratricol manufacturing processes, and new European Thyroid Association guidelines recommending Emcitate as long-term therapy for MCT8 deficiency.

• EMA review is on track, with responses to 180-day questions due by November 12, 2024, 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 patients.

• Over 220 patients are treated via Managed Access Programs in more than 25 countries.

• Directed share issuances raised SEK 300 million (approx. $30 million), led by Frazier Life Sciences, strengthening the financial position.

Financial highlights

• Revenue for the first nine months was SEK 35.3 million, up from SEK 25 million year-over-year; Q3 revenue was SEK 9.4 million, down from SEK 12.2 million in Q3 2023.

• 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.

• Gross profit for Q3 2024 was SEK 5.7 million versus SEK 9.5 million in Q3 2023.

• 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.

Outlook and guidance

• EMA approval process is progressing as planned, with no major surprises expected from the 180-day questions; regulatory review and approval timelines in the EU remain unchanged.

• 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.