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