Sedana Medical (SEDANA) investor relations material

Executive summary

• Submitted New Drug Application (NDA) to the FDA in June 2026, advancing US market entry and marking a major milestone.

• Group net sales were SEK 49.1 million in Q2 2026, flat year-over-year at constant exchange rates, with strong growth in all direct markets except Germany, which saw a 22% decline due to lower ICU patient volumes.

• Profitability improved with group EBITDA at -SEK 1.9 million in Q2 2026 (margin -4%), ex-US EBITDA margin at 2%, and gross margin rising to 73%.

• Cash position at quarter-end was SEK 52 million, with a new SEK 50 million credit facility secured for additional flexibility during the FDA review.

• Early Access Program in the US expanded, with several hospitals treating patients and more onboarding.

Financial highlights

• Q2 2026 net sales: SEK 49.1 million, down 1% year-over-year but flat at constant exchange rates; core business sales up 1% excluding contract manufacturing.

• Gross profit increased to SEK 35.8 million, with gross margin improving to 73% from 70% last year.

• Group EBITDA improved to -SEK 1.9 million from -SEK 4.1 million; ex-US EBITDA was positive at SEK 1 million.

• Cash and cash equivalents at quarter-end were SEK 52 million, down from SEK 81 million at the start of the quarter, mainly due to US program investments.

• Operating expenses were SEK 46 million in Q2 2026.

Outlook and guidance

• On track to deliver full-year guidance: approaching EBITDA break-even at Group level and mid- to high-single-digit EBITDA margin ex-US.

• Expecting cash burn and CapEx to decrease significantly following the NDA submission, with only potential increases if FDA review requires additional work.

• US regulatory decision expected in August or September for file acceptance, with potential approval in 6–10 months depending on Priority Review.

• Preparations underway for direct US launch, with significant market expansion potential upon FDA approval.