Egetis Therapeutics (EGTX) investor relations material

Executive summary

• FDA review of Emcitate NDA is on track for a September 28, 2026 PDUFA action date, with no advisory committee meeting planned and U.S. launch preparations complete.

• Q2 2026 revenue reached SEK 17.4 million, up 23% year-over-year at constant exchange rates, driven by European momentum and German reimbursement.

• Price negotiations for Emcitate in Germany concluded, supporting broader European commercialization and reimbursement.

• Oversubscribed SEK 350 million (USD 38 million) share issue completed at no discount to market price, strengthening the cash position.

• Tiago Nunes appointed as Chief Medical Officer to drive indication expansion.

Financial highlights

• Q2 2026 revenue was SEK 17.4 million, up 23% year-over-year at constant exchange rates.

• Gross profit for Q2 2026 was SEK 3.6 million; adjusted gross margin (excluding depreciation) was 79%.

• Operating/net loss for Q2 2026 was -SEK 109.3 million/-SEK 108.9 million, reflecting increased U.S. launch costs.

• Cash flow from operating activities was -SEK 93.9 million in Q2 2026.

• Cash position at June 30, 2026 was SEK 378.4 million.

Outlook and guidance

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

• Monetization of a Priority Review Voucher anticipated upon approval, with recent PRV sales ranging $180–220 million.

• Indication expansion into RTH-beta targeted, with clinical study initiation planned for 2027.

• Continued European rollout and pricing/reimbursement optimization.

• Focus on FDA engagement for Emcitate approval by September 28, 2026.