22 nd of November 2018 Disclaimer Forward-looking statements This - - PowerPoint PPT Presentation

22 nd of november 2018 disclaimer
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22 nd of November 2018 Disclaimer Forward-looking statements This - - PowerPoint PPT Presentation

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


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Q3 2018 Interim Report Presentation CEO Christer Ahlberg CMO 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

  • perations. 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.

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Financial highlights

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Financial Targets

During the period up until the approval of IsoConDa is

  • btained, the Company's goal is to increase sales with an

average of over 20 per cent per year while maintaining an

  • perating 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

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Financial highlights

High 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
  • r 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
  • f 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%

5 000 10 000 15 000 20 000 25 000 30 000 35 000 40 000 45 000

Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 KSEK

Gross ss Profit it, 12 months rollin ling

Gross Profit Gross Margin%

  • 10%
  • 5%

0% 5% 10% 15% 20%

  • 10000
  • 5000

5000 10000 15000 20000

Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 KSEK

EBITDA, 12 months s rollin lling

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

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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%

  • f 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

~6m

ICU patients

US

~SEK 6bn

European market potential

~6m

ICU patients

~SEK 6-15bn

US market Potential depending on pricing

* Market size based on company estimates.

STRICTLY PRIVATE AND CONFIDENTIAL

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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.

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  • 1. Registration of the pharmaceutical

candidate IsoConDa (isoflurane) in Europe.

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Development highlights

EUROPE

AnaConDa The medical Device already approved and CE mark received in 2003 and patent possible until 2036 Full approval of IsoConDa Sedana 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

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European market registration study

Phase III trial: Non-inferiority study of IsoConDa compared to propofol

Q2

2017 IsoConDa (N=150-275) Propofol (N=150-275) First patient included

48 ± 6h

treatment

24 hr, 7 & 30 days

follow-up

Study completion

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

20-25

Sites

STRICTLY PRIVATE AND CONFIDENTIAL INTERIM ANALYSIS at turn of year 2018

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  • 2. Development of registration work in the United

States with both AnaConDa and IsoConDa.

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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

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  • 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
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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

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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

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Development highlights

RoW

AnaConDa Approval of AnaConDa in Japan. Preparing launch of AnaConDa during 2019 with 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

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Financial Result

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Financial results Q3 2018 vs. Q3 2017

(MSEK)

P&L Balance Sheet Cash Flow

2018 2018 2017 2017 2018 2018 2017 2017 2018 2018 2017 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 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 Q3 30 September Q3 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.

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Questions