Sedana Medical AB · OMXSTO:SEDANA
Sedana Medical AB — Q3 2026 Earnings Presentation
21 slides from Sedana Medical AB's earnings presentation, Oct 22, 2026
Slide 1: Q3 2026 Report
Q3 2026 Report Johannes Doll, CEO Mikael Haag, CFO Peter Sackey, CMO October 22, 2026 <
Slide 2: Disclaimer
Disclaimer Forward-looking statements This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Sedana Medical’s busines
Slide 3: Q3 highlights: FDA review underway and return to sales growth
Q3 highlights: FDA review underway and return to sales growth Our 3 priorities Achieve growth in our Reach EBITDA Conquer the US ex-US business profitability market • Return to growth after flat • Improved EBITDA YTD • NDA accepted for review H1: Q3 group sales of 44.2 - Q3: -7 MSEK (-6) by FDA in A
Slide 4: We have accomplished a successful turn-around after Covid-19
We have accomplished a successful turn-around after Covid-19 Net Sales Ex-US EBITDA Group EBITDA Successful restructuring SEK million Percent Percent after Covid-19 • Streamlined corporate 200 3 2 headquarters and 179 improved overall spend -5 -5 effectiveness 154 147 -9 -17 • Shifted resources to t
Slide 5: Germany has shown significant improvement and actions are in place to return to growth
Germany has shown significant improvement and actions are in place to return to growth Net Sales MSEK Comments Q3 YTD • After steep sales decline in H1 (-18%), Germany came close to last year’s level in Q3 (-2%) • Market headwinds (fewer patients in ICU) -16% persisted, but to a lesser extent than i
Slide 6: Market headwinds from low patient numbers have affected performance in Germany
Market headwinds from low patient numbers have affected performance in Germany Germany order intake vs. ICU admissions with SARI1 Comments Both are trailing 12 months and indexed to January 2024 Germany order intake, trailing 12 months (EUR) • Our order intake has ICU admissions with SARI, trailing
Slide 7: All 'Other Direct Markets' showed growth in Q3
All ‘Other Direct Markets’ showed growth in Q3 Net Sales MSEK Comments • Continued growth in Spain, albeit at a softer level Q3 2026 YTD in the seasonally weaker Q3, which is affected by fewer patients and staff who are less familiar with our therapy. Focus is still on establishing inhaled +16% seda
Slide 8: Distributor markets continued to deliver solid growth
Distributor markets continued to deliver solid growth Net Sales MSEK Comments Q3 2026 YTD • Distributor market sales are generally more volatile due to irregular ordering patterns and higher stock levels +22% • Focus of 2025 activities was on providing targeted support to prioritized partners, layin
Slide 9: US approval would meaningfully expand our addressable market
US approval would meaningfully expand our addressable market Europe (direct markets) United States Ventilated adult ICU patients p.a. ~1 million >2 million Market potential inhaled sedation 3-4 BSEK 10-12 BSEK Status • Only approved ICU therapy • Two successful pivotal trials for inhaled sedation co
Slide 10: We are preparing for launching ourselves in the US
We are preparing for launching ourselves in the US Market Strategy • The United States have • We are preparing to build a commercial US a market potential of subsidiary and launch our therapy ourselves 10-12 BSEK (vs. 3-4 - Keep control of our assets and capture more BSEK in today’s direct of the up
Slide 11: FDA review is ongoing
FDA review is ongoing Progress towards US approval Why we would fit well into the US market ✓ Two successful Phase III trials Fit with hospital reimbursement mechanism - Primary endpoint met in both Under the DRG system, studies hospitals will benefit financially if patients leave the ICU faster - N
Slide 12: Secondary endpoints showed several potential benefits
Secondary endpoints showed several potential benefits (subject to approval and label decision by the FDA) Clinical results Relevance in practice • Greater opioid • Opioids cause (dose-dependent) issues in the ICU, such as constipation, respiratory depression, withdrawal and delirium reduction compar
Slide 13: 31 prominent sites were involved in the trials
31 prominent sites were involved in the trials – building a strong platform for KOL engagement and launch success INSPiRE-ICU1 INSPiRE-ICU2 • Vanderbilt • Rush University • University of Colorado • Columbia University • Cleveland Clinic • Massachusetts General Hospital • UT Southwestern • University
Slide 14: Patients are now being treated under our Early Access Program
Patients are now being treated under our Early Access Program The EAP Benefits Status update • An FDA pathway to gain Besides helping difficult-to- • Approximately ten access to an investigational sedate patients, the Early prominent US hospitals medical product before full Access Program brings val
Slide 15: US Medical Affairs activities are underway to generate market insights and engage HCPs
US Medical Affairs activities are underway to generate market insights and engage HCPs Advisory Boards HCP engagement and evidence generation • MD/RN/Pharm Ad Board Aug 2026 • Scientific exchange with trial sites – Patient categories outside INSPiRE-ICU • EAP network meetings and case reports – ECMO
Slide 16: New study and INSPiRE-ICU data support that sevoflurane-specific safety issues do not apply to isoflurane
A new study and data from INSPiRE-ICU support that sevoflurane-specific safety issues do not apply to isoflurane SAVE-ICU (investigator study in Canada) 1 Pooled INSPiRE-ICU data (post-hoc)2 • Largest study to date on isoflurane-based • AHRF patients (27% of all patients) sedation vs IV sedation - 7
Slide 17: Financial result in Q3 2026
Financial result in Q3 2026 Net sales (MSEK, 12m rolling) Net sales Q3’26: 44.2 (41.2) MSEK, +7% y/y (7% excl. fx) 200 • Return to growth with stronger performance in Germany and sustained 180 momentum in all other markets 160 • Sales in Germany decreased 3% y/y (-2% excl. fx) 140 • Other direct mar
Slide 18: Cash flow and available funds
Cash flow and available funds Change in cash position (MSEK) • Cash at end of Q3’26: 40 MSEK compared to 52 MSEK at 10 beginning of the quarter 5 0 • Cash flow from operations Q3’26: -3.0 (-1.1) MSEK -5 • EBITDA -7.0 (-5.6) MSEK -10 -15 • Working capital contributed positively with 4.1 (3.6) MSEK, m
Slide 19: Largest shareholders Sep 30, 2026
Largest shareholders Sep 30, 2026 No of shares Share Linc AB 16,523,697 16.6% Anders Walldov direct and indirect (Brohuvudet AB) 10,000,000 10.1% Lannebo Kapitalförvaltning AB 8,781,664 8.8% Premier Miton Investors 4,840,916 4.9% Ola Magnusson direct and indirect (Magiola Consulting AB) 4,312,288 4.
Slide 20: Our value creation plan
Our value creation plan Further profitable Successful launch in Continued cost growth in Europe the United States discipline • Build on positive ex-US • Take Sedana Medical to a • Optimize operating EBITDA and scale cash new scale, by launching in leverage from inherently generation through further
Slide 21: A secanamedical
A secanamedical