Egetis Therapeutics (EGTX) investor relations material

Executive summary

• FDA accepted the NDA for Emcitate for MCT8 deficiency, granting Priority Review with a PDUFA date of September 28, 2026.

• U.S. launch preparations for Emcitate are on track for Q4 2026, with strong patient identification and early access program expansion.

• European commercialization continues to build momentum, with revenue growth year-over-year and expanding geographic reach; Emcitate launched in Germany in May 2025.

• Successfully completed an oversubscribed SEK 350 million share issue, strengthening the cash position for upcoming launches.

• U.S. commercialization preparations accelerated, with expanded access program ongoing.

Financial highlights

• Q1 2026 revenue was SEK 13.4 million, up 9% year-over-year at constant exchange rates.

• Gross profit was negative SEK 0.2 million due to non-cash R&D depreciation; adjusted gross margin would have been 74%.

• Operating result was negative SEK 92.9 million, compared to negative SEK 62.9 million in Q1 2025, reflecting increased U.S. investments.

• Net loss for the quarter was SEK 94.5 million, compared to SEK 62.9 million in Q1 2025.

• Cash at quarter-end was SEK 142.5 million, down from SEK 272.8 a year earlier.

Outlook and guidance

• U.S. Emcitate launch expected in Q4 2026, pending FDA approval.

• Priority review voucher anticipated upon approval, with potential monetization in Q4; recent PRVs have sold for $150–200 million.

• Q2 2026 revenue expected to exceed Q1, driven by resolution of German reimbursement and broader market access.

• Pivotal study for RTH-beta indication planned to start in 2027, with study design to be finalized by end of summer 2026.

• Focus for 2026 is on FDA engagement for Emcitate approval, U.S. launch preparations, and optimizing European pricing and reimbursement.