Q3 2018 Interim Report Presentation CEO Christer Ahlberg CMO Peter Sackey 22 nd of November 2018
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 |
Q2 2018 Highlights Significant events during the period • Sedana Medical AB (publ) announced on the 26th of July that the company has received approval from the central ethical committee for its pivotal phase 3-study in Germany, IsoConDa, to continue to use the original study protocol after certain clarifications. This means that the study will resume in full after it was restricted in April this year. • Sedana Medical AB (publ) first direct sales of AnaConDa in the U.K. Significant events after the period • Sedana Medical AB (publ) announced that the company has received market approval for AnaConDa in Japan. • Sedana Medical AB (publ) presented a health economic analysis at the European Conference for Health Economics and Outcomes Research 2018 (ISPOR) in Barcelona, showing clinical and economic benefits of inhaled isoflurane sedation via AnaConDa versus conventional intravenous sedation with propofol or midazolam. 3 |
Financial highlights
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 High and improving gross margin Q3-2018 Gross ss Profit it, 12 months rollin ling • Net Sales 12,7 MSEK vs. 10,2 MSEK in Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q3 2017, 24% growth. 80% 45 000 40 000 75% 35 000 • Gross Margin 9,3 MSEK or 74% vs. 7,3 70% 30 000 25 000 KSEK or 72 % in Q3 2017 65% 20 000 60% 15 000 • EBITDA -1,0 MSEK or -7,6% vs. -980 or - 10 000 55% 5 000 9,6% in Q3 2017. 50% 0 Gross Profit Gross Margin% • Cash flow from operations was 1,9 MSEK. • -8,5 MSEK in cash flow from investments EBITDA development of which concern product development -7,1 EBITDA, 12 months s rollin lling MSEK. Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 • 20% 20000 Build up of European sales organisation, 15% 15000 26 employees Q3 2018 vs. 18 employees 10% 10000 Q3 2017 in average for the group in total. KSEK 5% 5000 • 0% 0 Continued sales and market investments -5% -5000 during Q3. -10% Post-approval -10000 EBITDA EBITDA % 6 | 6 |
Vision Inhalation sedation with AnaConDa and IsoConDa; a global standard of care therapy for mechanically ventilated ICU patients 7 |
Future strategic priorities 8 |
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 15 million ~6 m 30-50% ICU patients of patients require ventilation and need to be sedated ~SEK 6 bn Ventilated and sedated patients 4.5-7.5 million European market potential Patients ventilated more than 24h Patients ventilated less than 24h 2-4 million 2-4 million US X ~6 m Average number of sedation days 5 days ICU patients X AnaConDa/IsoConDa price per day in Europe (may be higher in the US) ~SEK 6-15 bn SEK 1,000 AnaConDa/IsoConda market potential US market SEK 10-20 billion Potential depending on pricing Sedana market potential 9 | 9 | * Market size based on company estimates.
Strategic Priorities 1. Registration of the pharmaceutical candidate IsoConDa (isoflurane) in Europe. 2. Development of registration work in the United States with both AnaConDa and IsoConDa. 3. Market building and preparation for an effective and successful launch in Europe when the therapy is registered.
1. Registration of the pharmaceutical candidate IsoConDa (isoflurane) in Europe.
STRICTLY PRIVATE AND CONFIDENTIAL Development highlights From proven therapy to approved standard of care EUROPE AnaConDa IsoConDa study The medical Device already approved and CE mark Phase III registration study initiated with 1 st received in 2003 and patent possible until 2036 patient in Q2 2017 and full 10-years exclusive from registration. Full approval of IsoConDa Sedana Medical will apply for approval of the pharma candidate IsoConDa for the EU market to IsoConDa study status get the full approval of the therapy Inhalation • Blinded interim analysis of variance in Sedation in ICUs preparation • Determines final sample size (300-550) Ongoing registration activities • Interim analysis and total number of patients • CTD components in preparation needed will be presented in Q1 2019 • Pediatric RCT plan submitted to EMA • Pending approval • Study start in 2020 Market authorization expected in 2020 12 | 12 |
STRICTLY PRIVATE AND CONFIDENTIAL European market registration study Phase III trial: Non-inferiority study of IsoConDa compared to propofol INTERIM ANALYSIS PRIMARY ENDPOINT at turn of year 2018 Non inferiority: proportion of time IsoConDa (N=150-275) First patient included with adequate sedation depth for Study isoflurane compared to propofol Q2 48 ± 6h 24 hr, 7 & 30 days completion treatment follow-up 2017 Propofol (N=150-275) SECONDARY ENDPOINTS After 12-16 months Wake-up times, proportion of time with Market authorization expected in EU spontaneous breathing, opiate requirements, ventilator-free days 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 13 | 13 |
2. Development of registration work in the United States with both AnaConDa and IsoConDa.
STRICTLY PRIVATE AND CONFIDENTIAL Development highlights From proven therapy to approved standard of care US US full approval of AnaConDa and IsoConDa • Sedana Medical has started the US registration work with a US agent • FDA meeting request – meeting planned end of March 2019 • The meeting with FDA will determine what further study and/or documentation will be required for USA registration • Information regarding requirements and time-plan will be communicated in Q2 2019 Time for projected market authorization communicated after FDA meeting 15 | 15 |
3. Market building and preparation for an effective and successful launch in Europe when the therapy is registered.
Strong and stable sales growth 24% Sales increase vs. Q3 2017 44% Sales increase YTD 2018 vs. 2017 26% Sales increase YTD 2017 vs. 2016 17 |
Recommend
More recommend
