Interim Report Q1 2019 Presentation CEO Christer Ahlberg CMO Peter Sackey CFO Maria Engström 8th of May 2019
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 business, fin ancial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “ may ”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to ident ify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realized. Factors that could cause these differences include, but are not limited to, implementation of Sedana Medical’s strategy and its ability to further grow, risks associated with the development and/or app rov al of Sedana Medical’s products candidates, ongoing clinical trials and expected trial results, the ability to further commercialize AnaConDa and IsoConDa, technology changes and new products in Sedana Medical’s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Sedana Medical disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 2 |
Vision Inhaled sedation with AnaConDa and IsoConDa; a global standard of care therapy for mechanically ventilated ICU patients 3 |
Strategic Priorities 1. Registration of the pharmaceutical candidate IsoConDa (isoflurane) in Europe. 2. Development of registration work in the US with both AnaConDa and IsoConDa. 3. Ensure solid growth of the AnaConDa sales and prepare for launch of IsoConDa.
Q1 2019 Highlights “The first quarter of 2019 has been our most successful so far regarding our commercial, clinical and regulatory development .” Significant events during the period • Sedana Medical AB (publ) has been approved for its planned pediatric study from the Pediatric Committee of EMA, European Medicines Agency, (PDCO). • Sedana Medical AB (publ) announced the results of the interim analysis for the pivotal phase III study which shows smaller variations in efficacy than anticipated. The study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients. • All time high in Sales Significant events after the period • During the pre-IND meeting the US Food and Drug Administration (FDA) was positive about the combination registration of IsoConDa and AnaConDa in the US. Sedana Medical now has a clear view of measures that have to be taken in order to reach marketing authorization approval. The meeting also confirmed the estimate of time and cost of a US approval, that is expected in 2024. 5 |
Financial highlights
STRICTLY PRIVATE AND CONFIDENTIAL Blockbuster market potential for IsoConDa/AnaConDa Breakdown of total market potential for IsoConDa/AnaConDa * Sedana will initially target the European and US markets Europe Annual number of patients visiting the ICU 30 million ~7,5 m 12 million ICU patients patients require mechanically ventilation ~SEK 7,5 bn Ventilated and sedated patients 8 million European market potential Average number of sedation days 2,5-5 days US X ~7 AnaConDa/IsoConDa price per day in ICU patients Europe (may be higher in the US) SEK 1,000 X ~SEK 9 bn AnaConDa/IsoConda market potential SEK 20-30 billion US market Potential depending on pricing Sedana market potential 7 | * Market size based on company estimates and Absolute Reports.
Financial Targets During the period up until the approval of IsoConDa is obtained, the Company's goal is to increase sales with an Pre- average of over 20 per cent per year while maintaining an registration operating profit before depreciation and amortization (EBITDA) that is not materially negative, in parallel to building up a larger sales and market organization Provided that an approval of IsoConDa in Europe is obtained, Post- the Company’s target is to reach a turnover exceeding 500 registration million SEK and an EBITDA margin of 40 percent three years after approval.
STRICTLY PRIVATE AND CONFIDENTIAL Financial highlights Gross margin development Q1-2019 Gross ss Profit it, 12 months rollin ling • All time high net sales of 17,8 MSEK vs. 15,5 Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 MSEK in Q1 2018, 15% growth individual quarter 45 000 80% and 31% rolling 12 months. 40 000 75% 35 000 • 30 000 70% Stable gross margin of 12,4 MSEK or 70% vs. 25 000 KSEK 65% 10,8 MSEK or 70 % in Q1 2018. 20 000 15 000 60% • EBITDA -2,6 MSEK or -14,8% vs. -0,8 MSEK or 10 000 55% 5 000 -7,8% in Q1 2018. 50% 0 • OPEX increased with 30% vs Q1 2018 due to Gross Profit Gross Margin% build up of European organisation and preparation for IsoConDa launch which means EBITDA development continued sales and market investments during EBITDA, 12 months s rollin lling Q1. Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 • 20000 25% 37 employees in average in Q1 vs. 30 employees 20% 15000 end of 2018 for the group in total. 15% 10000 • 10% Cash flow from operations was -1,8 MSEK. KSEK 5000 5% • 0% Cash flow from investments was -10,7 of which 0 -5% -9,8 MSEK concern product development. -5000 -10% Post-approval • -10000 -15% Total cash flow for the group in Q1 was -9,6 EBITDA EBITDA % MSEK. 9 | 9 |
1. Registration of the pharmaceutical candidate IsoConDa (isoflurane) in Europe.
STRICTLY PRIVATE AND CONFIDENTIAL European market registration study – The IsoConDa study Phase III trial: Non-inferiority study of IsoConDa compared to propofol PRIMARY ENDPOINT Non-inferiority: proportion of time IsoConDa (N=150) Study First patient included with adequate sedation depth for completion isoflurane compared to propofol Jan 2020 Q2 48 ± 6h 24 hr, 7 & 30 days treatment follow-up 2017 Propofol (N=150) MAA Submission SECONDARY ENDPOINTS Summer 2020 Wake-up times, proportion of time with spontaneous breathing, opiate After 12-16 requirements, ventilator-free days months Market authorization expected in EU (2021) STUDY SYNOPSIS STUDY SITES EXPLORATORY ENDPOINTS A randomized, controlled, open-label study to 20-25 confirm efficacy and safety of sedation with Differences in Sequential Organ isoflurane in invasively ventilated ICU patients Sites Failure Assessment, mortality rate in using the AnaConDa administration system addition to IsoConDa and AnaConDa specific endpoints 11 | 11 |
STRICTLY PRIVATE AND CONFIDENTIAL The IsoConDa study – a randomised controlled study to confirm the efficacy and safety of isoflurane sedation in invasively ventilated ICU patients using the AnaConDa Study status 30 April 2019: 223 of 300 patients included Nü Nü 12 | 12 |
STRICTLY PRIVATE AND CONFIDENTIAL Marketing Authorisation Application Activities in 2019-2020 EUROPE Recruitment of remaining 77 patients Data analysis 45 days Motivational work with current sites • Demographics Recruitment of new sites in Germany and • Primary and secondary endpoints Slovenia • Exploratory endpoints • Adverse events Last patient in at the turn of 2019/2020 Study data collection completed 30 days later Final report for entry in eCTD 60 days • Finalisation of study report and clinical Data preparation – 45 days summary Final monitoring of patient data entry • Entry in eCTD Data cleaning • Cross-referencing Query resolution • QA of full MAA • Database lock Submission Pediatric-IsoConDa study initiation Spring 2020 Market authorization Approval expected 12-16 months after submission = during 2021 13 | 13 |
STRICTLY PRIVATE AND CONFIDENTIAL The Ped-IsoConDa study 1. Protocol approved by EMA 2. 160 patients age 3-17 years 3. Treatment with isoflurane via the AnaConDa, or midazolam for 12-48 hours 4. Primary endpoint – time with adequate sedation, assessed with the COMFORT-B scale 5. Study start spring 2020 6. Approximately 15 study sites in Spain, Germany and Sweden 7. Ongoing site feasibility assessment and CRO selection 14 |
2. Development of registration work in the United States with both AnaConDa and IsoConDa.
US Registration Update
FDA meeting 25th March • Requirements for NDA application clarified • Toxicity studies to be performed • Human Factors Engineering Plan • Two confirmatory randomised controlled trials • In total 300-500 patients • German Study will also be included in isoflurane safety database • IND application in 2020 • NDA application in 2023 17 |
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