CMO Peter Sackey CFO Maria Engstrm 8th of May 2019 Disclaimer - - PowerPoint PPT Presentation

Interim Report Q1 2019 Presentation CEO Christer Ahlberg CMO Peter Sackey CFO Maria Engström 8th of May 2019

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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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Vision

Inhaled sedation with AnaConDa and IsoConDa; a global standard of care therapy for mechanically ventilated ICU patients

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.

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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.

Financial highlights

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Blockbuster market potential for IsoConDa/AnaConDa

Breakdown of total market potential for IsoConDa/AnaConDa*

Ventilated and sedated patients

8 million

Annual number of patients visiting the ICU

30 million 12 million

patients require mechanically ventilation

X

Average number of sedation days

2,5-5 days

X

AnaConDa/IsoConDa price per day in Europe (may be higher in the US)

SEK 1,000

AnaConDa/IsoConda market potential

SEK 20-30 billion

Sedana market potential

Sedana will initially target the European and US markets Europe

~7,5m

ICU patients

US

~SEK 7,5bn

European market potential

~7

ICU patients

~SEK 9bn

US market Potential depending on pricing

* Market size based on company estimates and Absolute Reports.

STRICTLY PRIVATE AND CONFIDENTIAL

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

9 | 9 |

Financial highlights

Gross margin development EBITDA development

Post-approval

STRICTLY PRIVATE AND CONFIDENTIAL

• All time high net sales of 17,8 MSEK vs. 15,5

MSEK in Q1 2018, 15% growth individual quarter and 31% rolling 12 months.

• Stable gross margin of 12,4 MSEK or 70% vs.

10,8 MSEK or 70 % in Q1 2018.

• EBITDA -2,6 MSEK or -14,8% vs. -0,8 MSEK or
• 7,8% in Q1 2018.
• OPEX increased with 30% vs Q1 2018 due to

build up of European organisation and preparation for IsoConDa launch which means continued sales and market investments during Q1.

• 37 employees in average in Q1 vs. 30 employees

end of 2018 for the group in total.

• Cash flow from operations was -1,8 MSEK.
• Cash flow from investments was -10,7 of which
• 9,8 MSEK concern product development.
• Total cash flow for the group in Q1 was -9,6

MSEK. Q1-2019

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 Q4-2018 Q1-2019

KSEK

Gross ss Profit it, 12 months rollin ling

Gross Profit Gross Margin%

• 15%
• 10%
• 5%

0% 5% 10% 15% 20% 25%

• 10000
• 5000

5000 10000 15000 20000 Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019

KSEK

EBITDA, 12 months s rollin lling

EBITDA EBITDA %

• 1. Registration of the pharmaceutical

candidate IsoConDa (isoflurane) in Europe.

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European market registration study – The IsoConDa study

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

Q2

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

48 ± 6h

treatment

24 hr, 7 & 30 days

follow-up

Study completion Jan 2020

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 (2021)

After 12-16 months

20-25

Sites

STRICTLY PRIVATE AND CONFIDENTIAL

MAA Submission Summer 2020

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Nü

Nü

– 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

The IsoConDa study

STRICTLY PRIVATE AND CONFIDENTIAL

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Marketing Authorisation Application Activities in 2019-2020

EUROPE

Recruitment of remaining 77 patients Motivational work with current sites Recruitment of new sites in Germany and Slovenia Last patient in at the turn of 2019/2020 Study data collection completed 30 days later Data preparation – 45 days Final monitoring of patient data entry Data cleaning Query resolution Database lock Market authorization Approval expected 12-16 months after submission = during 2021

STRICTLY PRIVATE AND CONFIDENTIAL

Data analysis 45 days

• Demographics
• Primary and secondary endpoints
• Exploratory endpoints
• Adverse events

Final report for entry in eCTD 60 days

• Finalisation of study report and clinical

summary

• Entry in eCTD
• Cross-referencing
• QA of full MAA
• Submission

Pediatric-IsoConDa study initiation Spring 2020

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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

STRICTLY PRIVATE AND CONFIDENTIAL

• 2. Development of registration work in the United

States with both AnaConDa and IsoConDa.

US Registration Update

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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

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Development highlights

RoW

AnaConDa Approval of AnaConDa in Japan. Preparing launch of AnaConDa 2019 with our Japanese distributor. Approved in Canada, Russia, Australia, South Korea and Israel. Investigating China possibilities Investigating possibilities in Middle East

STRICTLY PRIVATE AND CONFIDENTIAL

From proven therapy to approved standard of care

• 3. Ensure solid growth of the AnaConDa sales

and prepare for launch of IsoConDa. .

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All time high sales in Q1 2019

31%

Sales increase rolling 12 months

10000 20000 30000 40000 50000 60000 70000

Q1-2017 Q2-2017 Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 KSEK

Sale les s revenues s , 12 months rollin ling

21 | 21 |

Sales organization buildup and preparation in Q1 2019 for regulatory approval 2021 in EU

SEDANA MEDICAL CURRENT DIRECT SALES ORGANISATION Sedana Medical applies a direct sales model to key markets with plans to cover 15 EU countries in time for approval

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COUNTRIES

Q1 Highlights

SALES DEVELOPMENT

• ALL TIME HIGH SALES IN Q1 2019
• 31% GROWTH ROLLING 12 MONTHS
• 40% GROWTH IN FRANCE Q1 2019
• SIGNIFICANT SALES INCREASE IN UK AND NORDIC

Introduction of Sedana Medical Research Foundation

A unique opportunity for the scientific community to increase knowledge about sedation of critically ill patients

STRICTLY PRIVATE AND CONFIDENTIAL

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Q1 Commercial Highlights

Strengthened links with key opinion leaders, in Spain and France, where we hosted Advisory Boards Gold sponsor of the world's largest intensive care conference ISECEM in Brussels, where we organized eight very well-attended scientific symposia in the field of inhalation sedation. Participated in Germany's largest congress in intensive care in Bremen, where interest in Sedana Medical was very large. During our lecture, we had 250 attendees in the audience. Lectures in Japan and South Korea

Financial Result

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Financial results Q1 2019 vs. Q1 2018

(MSEK)

P&L Balance Sheet Cash Flow

2019 2019 2018 2018 2019 2019 2018 2018 2019 2019 2018 2018 Revenues ASSETS Net sales 17,8 15,5 Intangible assets 61,1 31,4 Cash flow from operations bef. change in w.c.

• 1,8
• 0,8

Capitalized development expenses 0,0 0,0 Tangible assets 5,1 4,3 Other operating income 0,8 0,4 Financial assets 1,1 1,4 Change in w.c. 2,7

• 1,6

18,6 15,8 Total Fixed assets 67,3 37,0 Operating cost and expenses Cash flow from operations after change in w.c. 0,8

• 2,4

Cost of goods sold

• 5,4
• 4,7

Inventory 4,2 5,2 External expenses

• 6,8
• 5,8

Receivables 8,8 8,0 Cash flow from investment activities

• 10,7
• 4,4

Personnel expenses

• 8,6
• 6,1

Cash and cash equivalents 149,8 79,2 Depreciation and amortisation

• 1,0
• 0,9

Total current assets 162,8 92,4 Cash flow from financing activities 0,3 0,5 Other operating expenses Operating income

• 3,7
• 1,7

TOTAL ASSETS 230,1 129,5 Cash flow for the period

• 9,6
• 6,3

Income from financial items EQUITY & LIABILITIES Result from securities and long term receivables 0,0 0,0 Share capital 1,9 1,7 Financial income 1,4 2,1 Other equity 213,1 114,9 Financial expenses

• 0,2
• 0,4

Total equity 215,0 116,6 Income after financial items

• 2,5

0,0 Long term liabilities 0,0 0,0 Income before taxes

• 2,5

0,0 Current liabilities 15,1 12,9 Taxes

• 0,4
• 0,1

Net Income

• 3,0
• 0,1

TOTAL EQUITY AND LIABILITIES 230,2 129,5 Q1 Q1 31 March Q1 Q1

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Largest shareholders at the end of March 2019

Number of shares

Share (%)

Linc AB 1 916 901 9,94% Sten Gibeck 1 605 744 8,33% Magiola Consulting 1 340 867 6,96% Anders Walldov direct and indirect (Brohuvudet AB) 1 200 000 6,23% Anades Ltd. 1 068 083 5,54% Ron Farrell 851 062 4,42% SEB Luxemburg 716 430 3,72% State Street Bank & Trust 712 731 3,70% Handelsbanken Microcap 548 711 2,85% Bjässbodarna Invest 517 083 2,68% Eklund Konsulting AB 474 156 2,46% BNP Paribas 463 085 2,40% Handelsbanken småbolagsfond 450 000 2,33% Swedbank Robur Microcap 450 000 2,33% Nordnet pensionsförsäkrings AB 445 638 2,31% Fifteen largest shareholders 12 760 491 66,20% Others * 6 516 100 33,80% Totalt 19 276 591 100,00%

* CEO's ownership is 230 000 shares.

Questions