Post on 16-Oct-2020
Q3 2018 Interim Report Presentation
CEO Christer AhlbergCMO Peter Sackey
22nd of November 2018
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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, financial 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 identify 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 approval 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.
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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.
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
average of over 20 per cent per year while maintaining an
operating profit before depreciation and amortization
(EBITDA) that is not materially negative, in parallel to building
up a larger sales and market organization
Pre-
registration
Provided that an approval of IsoConDa in Europe is obtained,
the Company’s target is to reach a turnover exceeding 500
million SEK and an EBITDA margin of 40 percent three years
after approval.
Post-
registration
6 |6 |
Financial highlightsHigh and improving gross margin
EBITDA development
Post-approval
STRICTLY PRIVATE AND CONFIDENTIAL
• Net Sales 12,7 MSEK vs. 10,2 MSEK in
Q3 2017, 24% growth.
• Gross Margin 9,3 MSEK or 74% vs. 7,3
or 72 % in Q3 2017
• EBITDA -1,0 MSEK or -7,6% vs. -980 or -
9,6% in Q3 2017.
• Cash flow from operations was 1,9 MSEK.
• -8,5 MSEK in cash flow from investments
of which concern product development -7,1
MSEK.
• Build up of European sales organisation,
26 employees Q3 2018 vs. 18 employees
Q3 2017 in average for the group in total.
• Continued sales and market investments
during Q3.
Q3-2018
50%
55%
60%
65%
70%
75%
80%
0
5 000
10 000
15 000
20 000
25 000
30 000
35 000
40 000
45 000Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018
KSEK
Gross Profit, 12 months rolling
Gross Profit Gross Margin%
-10%
-5%
0%
5%
10%
15%
20%
-10000
-5000
0
5000
10000
15000
20000Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018
KSE
K
EBITDA, 12 months rolling
EBITDA EBITDA %
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Vision
Inhalation sedation with AnaConDa and IsoConDa;
a global standard of care therapy for mechanically ventilated ICU patients
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Future strategic priorities
9 |9 |
Blockbuster market potential for IsoConDa/AnaConDa
Breakdown of total market potential for IsoConDa/AnaConDa*
Ventilated and sedated patients
4.5-7.5 million
Annual number of patients visiting the ICU
15 million
Patients ventilated less than 24h
2-4 million
Patients ventilated more than 24h
2-4 million
30-50% of patients require ventilation and need to be sedated
X
Average number of sedation days
5 days
X
AnaConDa/IsoConDa price per day in Europe (may be higher in the US)
SEK 1,000
AnaConDa/IsoConda market potential
SEK 10-20 billion
Sedana market potential
Sedana will initially target the European and US markets
Europe
~6mICU patients
US
~SEK 6bnEuropean market
potential
~6mICU patients
~SEK 6-15bn
US market Potential depending on pricing
* Market size based on company estimates.
STRICTLY PRIVATE AND CONFIDENTIAL
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.
12 |12 |
Development highlights
EUROPE
AnaConDa
The medical Device already approved and CE mark received in 2003 and patent possible until 2036
Full approval of IsoConDaSedana Medical will apply for approval of the pharma candidate IsoConDa for the EU market to get the full approval of the therapy Inhalation Sedation in ICUs
Ongoing registration activities• CTD components in preparation• Pediatric RCT plan submitted to EMA
• Pending approval• Study start in 2020
Market authorization expected in 2020
STRICTLY PRIVATE AND CONFIDENTIAL
From proven therapy to approved standard of care
IsoConDa study
Phase III registration study initiated with 1st
patient in Q2 2017 and full 10-years exclusive from registration.
IsoConDa study status
• Blinded interim analysis of variance in preparation
• Determines final sample size (300-550)• Interim analysis and total number of patients
needed will be presented in Q1 2019
13 |13 |
European market registration study
Phase III trial: Non-inferiority study of IsoConDa compared to propofol
Q22017
IsoConDa (N=150-275)
Propofol (N=150-275)
First patient included
48 ± 6htreatment
24 hr, 7 & 30 daysfollow-up
Studycompletion
PRIMARY ENDPOINT
Non inferiority: proportion of time
with adequate sedation depth for
isoflurane compared to propofol
SECONDARY ENDPOINTS
Wake-up times, proportion of time with
spontaneous breathing, opiate
requirements, ventilator-free days
EXPLORATORY ENDPOINTS
Differences in Sequential Organ
failure Assessment, mortality rate in
addition to IsoConDa and AnaConDa
specific endpoints
A randomized, controlled, open-label study to
confirm efficacy and safety of sedation with
isoflurane in invasively ventilated ICU patients
using the AnaConDa administration system
STUDY SYNOPSIS STUDY SITES
Market authorization expected in EU
After 12-16 months
20-25Sites
STRICTLY PRIVATE AND CONFIDENTIAL
INTERIM ANALYSISat turn of year 2018
2. Development of registration work in the United States with both AnaConDa and IsoConDa.
15 |15 |
Development highlights
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
STRICTLY PRIVATE AND CONFIDENTIAL
From proven therapy to approved standard of care
3. Market building and preparation for an effective and successful launch in Europe when the therapy is registered.
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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
18 |18 |
COMMERCIAL HIGHLIGHTS
Sedana Medical applies a direct sales model to key markets with plans to cover up to 15 EU countries in time for approval
SEDANA MEDICAL CURRENT DIRECT SALES ORGANISATION
STRICTLY PRIVATE AND CONFIDENTIAL
Germany: Growing, stands for 86% of total sales. >550 ICUs using AnaConDa
regularly. Military hospital tender. Increased awareness of inhalation sedation thanks to
participating at congresses/exhibitions, higher customer share of voice thanks to more
sales reps in the field. IsoConDa approval coming closer also positive.
France: Growing and with 3 KAMs employed the number of ICUs using AnaConDa is
increasing including more frequent recurrent orders from old customers. The biggest
ICU in France in Paris trained on AnaConDa. Many ICUs are planned for training during
the coming year.
Nordic: Sedana Medical started its own sales operations during 2018. In Norway we
have >10 ICUs users of AnaConDa. Big interest in Finland and first patient treated in
Denmark. Sahlgrenska in Sweden has been trained in inhalation sedation treatment
with AnaConDa.
UK/Ireland: Direct sales set-up from July 1st 2018 and employees from October 1st.
First direct sales orders from 2 ICUs (Liverpool and Hull).
Spain: Growing, even though only 1 KAM. The interest is increasing. Planning for
additional sales resources
19 |19 |
A cost-consequence analysis of AnaConDa versus propofol and midazolam in the long-term sedation of critically-ill surgical patients from the UK NHS perspective
FIGURE 2: Percentage risk of mortality
20 |20 |
Development highlights
RoW
AnaConDa
Approval of AnaConDa in Japan. Preparing launch of AnaConDa during 2019with our Japanese distributor.
Approved in Canada, Russia, Australia and South Korea and now in ISRAEL.
The South Korean distributor supplied for Reimbursement in Q3 2017
Investigating China possibilities
Investigating possibilities in Middle East
STRICTLY PRIVATE AND CONFIDENTIAL
From proven therapy to approved standard of care
Financial Result
22 |22 |
Financial results Q3 2018 vs. Q3 2017(MSEK)
P&L Balance Sheet Cash Flow 2018 2017 2018 2017 2018 2017
Revenues ASSETS
Net sales 12,7 10,2 Intangible assets 44,3 19,9
Cash flow from operations bef.
change in w.c. -0,3 -1,9
Capitalized development expenses 0,0 0,0 Tangible assets 5,4 3,7
Other operating income 0,3 0,0 Financial assets 1,9 0,8 Change in w.c. 2,2 -14,2
13,0 10,2 Total Fixed assets 51,6 24,4
Operating cost and expenses
Cash flow from operations after
change in w.c. 1,9 -16,0
Cost of goods sold -3,3 -2,9 Inventory 4,8 2,8
External expenses -5,4 -4,2 Receivables 6,4 9,5 Cash flow from investment activities -8,5 -2,3
Personnel expenses -4,9 -4,1 Cash and cash equivalents 175,2 90,2
Depreciation and amortisation -1,1 -1,3 Total current assets 186,3 102,4 Cash flow from financing activities 0,2 7,9
Other operating expenses 0 0
Operating income -2,1 -2,3 TOTAL ASSETS 237,9 126,8 Cash flow for the period -6,4 -10,5
Income from financial items EQUITY & LIABILITIES
Result from securities and long term
receivables 0,0 0,0 Share capital 1,9 1,1
Financial income 1,6 0,3 Other equity 219,4 115,3
Financial expenses -2,0 -1,2 Total equity 221,3 116,4
Income after financial items -2,5 -3,1
Long term liabilities 0,0 1,6
Income before taxes -2,5 -3,1
Current liabilities 16,6 8,9
Taxes -0,1 0,3
Net Income -2,6 -2,8 TOTAL EQUITY AND LIABILITIES 237,9 126,8
Q3 30 September Q3
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Largest shareholders at the end of September 2018
Number of
shares Share (%)
Linc AB 1 901 901 10,01%
Sten Gibeck 1 585 744 8,34%
Magiola Consulting 1 207 867 6,35%
Michael Ryan 1 068 083 5,62%
Brohuvudet AB 852 635 4,49%
State Street Bank & Trust 774 177 4,07%
Ron Farrell 898 897 4,73%
SEB 710 971 3,74%
Alto Invest SA 524 436 2,76%
Avanza pension 496 784 2,61%
Swedbank Robur Microcap 475 000 2,50%
Eklund Konsulting AB 474 156 2,49%
BNP Paribas 463 400 2,44%
JP Morgan Europe Ltd 460 431 2,42%
Nordnet Pensionsförsäkring AB 371 991 1,96%
Fifteen largest shareholders 12 266 473 64,53%
Other * 6 742 118 35,47%
Total 19 008 591 100,00%
* CEO's ownership is 230 000 shares.
Questions