MANAGEMENT PRESENTATION - Sedana Medical · This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend

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MANAGEMENT PRESENTATION

September 2019

MANAGEMENT PRESENTATION

SEPTEMBER 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 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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Inhaled sedation with AnaConDa & IsoConDa: A global standard of care therapy for mechanically ventilated ICU patients.

ENABLING INHALATION SEDATION COMPANY IN BRIEF

• Sedana Medical is a Swedish MedTech company on its way to becoming a pharmaceutical company.

• AnConDa enables inhalation sedation of mechanically ventilated patients in intensive care.

• AnaConDa administers the volatile drug IsoConDa (isoflurane) via the respiratory tract in an efficient, safe, simple and cost-effective manner.

• AnaConDa is approved in Europe, South Korea, Japan and a number of other countries.

• Positive Pre-IND FDA interaction to combination registration of

AnaConDa and IsoConDa through the 505 (b) (2) pathway.

• MAA approval expected 2021 and NDA approval expected 2024.

VISION

Sales

EUR 5.5m 2018

Sales growth

24%RTM June 2019

Global market

EUR 2-3bn annually (estimated)

“Inhalation sedation is a potential paradigm shift in intensive care.”

– Professor Daniel Talmor, anaesthesiologist and physician at Beth Israel Deaconess Medical Centre

1. Current ICU sedation presents many challenges, uncertainties and risks.

2. Inhalation sedation has many inherent benefits, but has not been practically possible in the past.

3. Sedana Medical is uniquely positioned to enable inhalation sedation in ICUs globally.

4. Sedana Medical has demonstrated proof of concept with rapidly growing adoption despite off-label status.

5. Sedana Medical sees blockbuster potential for AnaConDa & IsoConDa.

6. Phase III clinical trial of IsoConDa ongoing with study completion estimated for January 2020.

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History of Sedana MedicalA. Appendix

1988

First studyof inhalation

sedation using isoflurane

Kong et al. 1988

1999

AnaConDa first used

in Sweden in the mid 90's and tested in a

clinical setting for the first time in 1999

2005

Company Foundedin Uppsala Sweden

2007

First AnaConDa salesSedana establishes test

market in Germany

2008

Reduced ICU StaysStudy shows that short-term sevoflurane sedation using

AnaConDa after cardiothoracic surgery significantly reduces ICU stay, venillation time and

hospital stay

2010

New ICU Sedation Guidelines

For the first time Inhalation Sedation is part of the new ICU

Sedation guidelines in Germany

20172015

Reduced MortalityStudy finds that one year mortality is significantly lower in isoflurane vs. IV

sedatated patients

Inititation of Registration

Study

Approval and Sales of AnaConDa-S

(50ml) in EU

Approval of AnaConDa in S.Korea as first

country in Asia

Listed at Nasdaq First North Stockholm

2018

First cost consequence analysis presented

Proving cost-effectiveness of AnaConDa vs IV -sedation

First sales in the UKDirect sales with

first hire in the UK

Approval of AnaConDa in

Japan

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TABLE OF CONTENTS

3Large & clearly defined market opportunity for replacement of standard of care

4 Development & commercialisation

5Board & Management with extensive experience in commercialisation of medtech and pharmaceutical products

6 Financial highlights

1 Sedation in ICUs represents a large unmet clinical need

AnaConDa & IsoConDa – a superior combination for ICU sedation2

OFFON

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Intensive care units and sedation: A brief introduction

Why are patients sedated in the ICU?Overview: Intensive care units

INTENSIVE CARE UNIT (ICU)

ICUs cater to critically ill patients with severe illnesses and injuries

30-50% of patients require mechanical ventilation to breathe1

Common conditions treated at ICUs include:

Trauma, multiple organ failure, sepsis and acute respiratory distress syndrome

SEDATION IN THE ICU

Sedation is primarily used for mechanically ventilated patients

The purpose of sedation of mechanically ventilated ICU patients is to provide comfort via short- and long-term reduction of

anxiety and distress to facilitate safety by:

Sedated patients are better able to tolerate many of the procedures performed during ICU care

1. Sedation in ICUs represents a large unmet clinical need

Reducing autonomic stress, optimising ventilator treatment - asynchrony and avoiding self-extubation

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Sedation in the ICU represents a large unmet clinical need

A better sedative exists but it hasn’t been possible to useCurrent sedation methods fall short on key factors

INHALATION SEDATION

Tendency to reduce hallucination episodes/delirium6

INTRAVENOUS SEDATION

Drug level concentration is difficult to monitor

Tolerance, withdrawal symptoms or agitation/delirium (20-35% of cases)3

Significantly increasing ICU stay (by up to 40%)Delirium increases the mortality risk significantly

Eliminated through the liver or kidneys

Extra burden on liver/kidneys. ICU patients frequently have impaired organ function

Eliminated through the lungs

Inhaled sedatives such as Isoflurane are almost entirely eliminated through the lungs

Long and unpredictable wake-up times (90 min – 130 h)2

High mortality4

In long-term ventilated patients

Reduced mortality4

In long-term ventilated patients

Significantly reduced wake-up time (10-20 min)5

Improving the planning of clinical workflow and reducing time to extubation

Controlled sedation depth

With less under and over sedation


Prolonging the stay in the ICU and making extubations difficult to plan

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Inhalation sedation hasn’t been practically possible in the past

AnaConDa finally makes inhalation sedation possible in the ICUThe tools for administration exist but not for use in the ICU

ANESTHESIA MACHINE ANACONDA

Anesthesia machines are used for administration of general anaesthesia in the operating room.

These machines are capable of inhalation sedation, however, they are not approved or intended for use in the intensive care unit setting and they are not used due to their size and high capital

and usage costs making them unsuitable for prolonged use.

The additional need for administration and monitoring by a specialist makes the use of these machines labour intensive and

impractical for inhalation sedation.

AnaConDa is a cost-effective CE marked disposable system for the delivery of inhaled sedatives built for use in the ICU.

By incorporating a vaporizer, circle system, heat & moisture exchanger and a bacterial/viral filter into a single disposable

device AnaConDa is able to make inhalation sedation possible and practical in the ICU.

The AnaConDa device is simply attached to a traditional ICU ventilator in order to deliver controlled sedation to patients.


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AnaConDa – making inhalation sedation possible in the ICU

Compact device encompassing the most important elements of an anaesthesia machine for ICU use

Vaporizer Circle systemHeat & moisture exchanger

Bacterial/Viral filter

AnaConDa

- Simple and convenient to administer – can be administered by a

nurse

- Low cost disposable system for administration of inhaled sedatives

- Accurate patient dosing minimizing over and under sedation

- Compact size and convenient design – Seamless integration into

clinical workflow

- Low consumption of sedative agent – >90% recirculated to patient

- Proven safety with no workplace pollution in the ICU

- Combines 4 functions (vaporizing, reflecting, humidifying and

filtering) disposable delivery system - no electricity or maintenance

- CE marked with strong sales growth in Europe, patent possible until

2036


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IsoConDa® – a superior inhaled sedative for use in the ICU

Safe and proven inhaled sedative administered by a practical and cost effective delivery system

IsoConDa®

- IsoConDa® (Isoflurane) is a generic volatile anaesthetic with a long record of use in the

operating theatre

- Currently not approved for use as a sedative in the ICU setting but is used off label

together with AnaConDa

* Based on studies performed on mice.

IsoConDa® (Isoflurane)

- Significant reduction in mortality4

- Potential for reduced ICU stay duration: No development of

tolerance, dependence, withdrawal symptoms and/or delirium and

fewer hospital acquired infections (HAI): expected to lead to

shorter ICU stays

- Organ protective*: Inhaled sedatives have potentially cardio-,

neuro- and lung-protective properties7

- Eliminated through the lungs (IV drugs are metabolised in the liver

and eliminated through the kidneys): isoflurane is almost 100%

eliminated through the lungs

- Bronchodilator effect: Improves lung function for patients with

COPD, ARDS, Asthma etc.8

- Reduction of opiate dependency: Reduces the need for analgesics

such as remifentanil and other opioids by >35% compared to when

using IV sedation, with benefits to the associated cost of sedation9


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Appendix


AnaConDa & IsoConDa – a superior combination for ICU sedation

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What do we expect from a modern ICU sedative?

Volatile anaesthetics have been proposed as ideal ICU sedatives10


1. Accumulation

• Long half-life – context sensitive half-life period

2. Metabolism and metabolites

• High organ metabolism through liver or kidney

• ICU patients frequently have impaired organ function

• Active metabolites

3. Wake up times

• Long and unpredictable wake up times

• Extubation difficult to plan

• Prolonging the stay in the ICU

4. Adverse effects

• Withdrawal symptoms/hallucinogenic effects

• Delirium

• Interaction with other drugs

• Dependency/tolerances (tachyphylaxis)

• Propofol infusion syndrome

5. Sedation depth

• No monitoring of drug level

1

2

3

4

5

Minimal accumulation

Minimal metabolism and no active metabolites

Rapid on- and offset

Few adverse effects

Readable drug level concentration

Sedation with volatile anaesthetics = Inhaled sedation

Modern ICU sedative requirements

Potential issues, challenges and side-effects with IV sedation in ICU

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Sedana Medical has over a decade of clinical experience2. AnaConDa & IsoConDa – a superior combination for ICU sedation

See Appendix for list of select publications.

More than 90 peer-reviewed publications

Intensive Care Med (2006) 32:927–933

DOI 10.1007/s00134-006-0163-0

PEDIATRIC BRIEF REPORT

Venkat Shankar

KevinB. Churchwell

Jayant K. Deshpande

Isoflurane therapy for severe refractory status

asthmaticus in children

Received: 23 August 2005

Accepted: 15 March 2006

Published online: 5 May 2006

© Springer-Verlag 2006

V. Shankar (✉) ·K. B. Churchwell ·

J. K. Deshpande

Monroe Carrell Jr. Children’s Hospital at

Vanderbilt, Division of Pediatric Critical

Care Medicine,

5121 B Doctor’sOffice Tower, Nashville

TN 37232-9075, Tennessee, USA

e-mail: [email protected]

Tel.: +1-615-9361305

Fax: +1-615-9363467

Abstract Objective: To describe the

use of inhaled isoflurane in a series

of children with life-threatening

asthma. Design: Retrospective case

series. Setting: Pediatric intensive

care unit of a tertiary-care children’s

hospital. Ten children ranging in age

from 1 to 16 years with 11 episodes

of severe asthma requiring invasive

mechanical ventilation in the pedi-

atric intensive care unit over a 5-year

period. Results: Isoflurane resulted

in an improvement in arterial pH

and a reduction in partial pressure of

arterial carbon dioxide (PaCO2) in all

the 11 instances. This effect was sus-

tained in 10 cases and led to clinical

improvement and rapid weaning from

mechanical ventilation. One child

failed to show sustained response

and was placed on veno-venous

extracorporeal membrane oxygena-

tion. One child died secondary to

anoxic brain injury sustained prior

to hospitalization. Hypotension was

the major side effect, and occurred in

8 children necessitating vasopressor

support. Conclusions: Isoflurane

improves arterial pH and reduces

partial pressure of arterial carbon

dioxide in mechanically ventilated

children with life-threatening status

asthmaticus who are not responsive

to conventional management.

Keywords Respiratory failure ·

Status asthmaticus · Pediatrics ·

Isoflurane

Introduction

The prevalence of childhood asthma and the resultant

mortality continues to rise despite many advances in

prevention and treatment [1, 2]. Acute respiratory failure

necessitating mechanical ventilation is a rare but life-

threatening complication of asthma [3]. The increased

use of non-invasive ventilation for acute exacerbation of

asthma in recent years has further decreased the need

for endotracheal intubation and mechanical ventilation

in a child with status asthmaticus [4, 5, 6]. Neverthe-

less, positive pressure mechanical ventilation can be

a challenging treatment modality in children with status

asthmaticus. High peak airway pressures and dynamic

hyperinflation often lead to barotrauma, pulmonary air

leaks and hemodynamic compromise [3, 7, 8].

Isoflurane, an inhalational anesthetic agent with

bronchodilating properties, has been used in patients with

severe catastrophic asthma exacerbations refractory to

conventional therapy [9, 10, 11, 12, 13]. We describe

our experience with use of isoflurane in 11 episodes of

life-threatening acute asthma in children over a 5-year

period in the intensive care unit (ICU) of a tertiary-care

children’s hospital.

Methods

Medical records of children with refractory status asth-

maticus who were administered isoflurane over a 5-year

period were identified and reviewed. Details of demo-

graphic information, medical history, pharmacological

agents used, blood gas parameters and the dose and

duration of isoflurane administered were collected. Se-

quential pH and PaCO2 were analyzed. Clinical outcomes

measured included duration of mechanical ventilation,

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Therapeutical benefits by using inhaled anaesthetics2. AnaConDa & IsoConDa – a superior combination for ICU sedation

Pulmonary therapeutic effects for patients with impaired gas exchange11

✓ Improved oxygenation✓ Reduction of pulmonary inflammatory response✓ Bronchodilatory effect

On-off effects and reliable wake-up with inhaled sedation12

✓ Shorter time to extubation…✓ Shorter time to cooperation…✓ Shorter ventilator time and ICU stay…

…when compared with intravenous sedation

Reliable effect and safety with inhaled sedation for the distressed patient13

✓ Works in all patients – full range sedative✓ No need for polypharmacy✓ Few problems after wake-up✓ Patients are more lucid and calm with less hallucinations and delusions✓ No/low risk of tolerance development, ceiling effect and withdrawal

symptoms✓ Reduction of opioid use

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IsoConDa® provides clear benefits over current standard of care

IsoConDa® IV sedationBenefits

* Price for both AnaConDa and IsoConDa together. ** See appendix. *** Price of IV sedation is dependent on dose, number of pharmaceuticals used in the cocktail, severity of the patient and country. Excludes cost of prolonged ICU stay and additional treatment required due to complications in sedation. Cost for longer ICU –stay due to IV sedation is not included.

EUR 1-3kDaily cost of an

ICU bed in Europe14 $4-16bnAnnual cost of delirium

from ventilated patients in the US15

2. AnaConDa & IsoConDa – a superior combination for ICU sedation

ON-OFF EFFECTS AND RELIABLE WAKE UP

Significantly reduced wake-up time2 10-20 min 90 min – 130 h

Reduction in ICU stay duration for deep sedation patients10 4-16 days 6-27 days

Significantly reduced time to extubation (ventilator tube removal)2 10-35 min 150-600 min

RELIABLE EFFECT AND SAFETY FOR THE DISTRESSED PATIENT

Limits the occurrence of hallucination episodes/delirium6 2 of 10 patients 5 of 7 patients

Reduction in use of opiates9 2.7 mg/hour 4.2 mg/hour

POTENTIALLY ORGAN PROTECTIVE PROPERTIES

Reduced in-hospital mortality in long-term ventilated patients (>96h)4 40% 63%

Reduced 1 year mortality in long-term ventilated patients (>96h)4 50% 70%

Improved gas exchange** ** **

Price per day EUR 100* EUR 20-300***

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A potential paradigm shift in intensive care2. AnaConDa & IsoConDa – a superior combination for ICU sedation

“This therapy helps us achieve two important objectives – sedation and organ protection – with one single drug. Inhalation sedation is a potential paradigm shift in intensive care.”

– Professor Daniel Talmor, anaesthesiologist and physician at Harvard/Beth Israel Deaconess Medical Centre

Kerstin Röhm, PhD, MD at the Israeli Annual Intensive Care Meeting – 4th July 2019, Tel-Aviv

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Appendix



TABLE OF CONTENTS

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Breakdown: total market potential for IsoConDa/AnaConDa*

Blockbuster 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 (will be higher in the US and

lower in Asia)

EUR 100

AnaConDa/IsoConda market potential

EUR 2-3 billion

Europe

~7,5mICU patients

USA

~EUR 700mEuropean market

potential

~7mICU patients

~EUR 900mUS market potential depending on pricing

Asia/Pacific

~12,5mICU patients

~EUR 1bnAsian/Pacific

market potential

Regional market potential

3. Large & clearly defined market opportunity for replacement of standard of care

*Market size based on company estimates.

19 |19 |

Rapidly increasing adoption and usage despite off-label status

Increasing use globallyCase study: AnaConDa in Germany

Clinics actively using AnaConDa

~600ICUs use AnaConDa

• In 2010, new guidelines for sedation were published in Germany.

• The guidelines put forward inhalation sedation and the use of isoflurane as an alternative to IV sedation in intensive care for certain patient groups.

• The new guidelines together with positive statements from a number of German KOLs have led to extensive use of AnaConDa in Germany.

• Sedana Medical’s largest market is currently Germany, which together with other markets where it conducts direct selling, has functioned as a test market to study demand.

5%of total market potential

Current use of AnaConDa

Proven in clinical practice

3. Large & clearly defined market opportunity for replacement of standard of care

24%Sales growth,

rolling 12 months June 2019

AnaConDa in Germany

>300,000AnaConDa units sold

>500,000treatment days

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Strategic priorities and 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, 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 in EU exceeding 500 million SEK and an EBITDA margin of 40 percent three years after approval.

Post-registration

Strategic priorities Financial targets

4. Development & commercialisation

1

2

3

Development and commercialisation: Europe• Registration of the pharmaceutical candidate IsoConDa

(isoflurane) in 2021• Ensure solid growth of AnaConDa sales and prepare for

launch of IsoConDa in 2021

Development and commercialisation: USA• Development of registration work in USA with both

AnaConDa and IsoConDa for NDA approval in 2024• Commercialisation strategy for USA to be decided ~2022.

Development and commercialisation: RoW• Register AnaConDa and IsoConDa in relevant markets in

Asia, such as Japan and China

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European market registration study – the IsoConDa study

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

Q22017

IsoConDa (N=150)

Propofol (N=150)

First patient included

48 ± 6htreatment

24 hr, 7 & 30 daysfollow-up

Studycompletion

Jan 2020

Market authorization expected in EU (2021)

After 12-16 months

MAASubmission

Summer2020

21 German sites3 Slovenian sites


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.

300 patients in total

PRIMARY ENDPOINT

Non-inferiority: proportion of time with

adequate sedation depth for isoflurane

compared to propofol

EXPLORATORY ENDPOINTS

Differences in Sequential Organ Failure

Assessment, mortality rate in addition to

IsoConDa and AnaConDa specific

endpoints

SECONDARY ENDPOINTS

Wake-up times, proportion of time with

spontaneous breathing, opiate

requirements, ventilator-free days

STUDY SITESRECRUITMENT

• 234 patients recruited

• Last patient in during the turn of the year 2019/2020

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The IsoCOMFORT study for EU and USA

Approved paediatric investigation plan


~18 Sites in Spain, Germany, France & Sweden

A complete Marketing Authorization Application (MAA) for drugs in EU must include a PDCO agreed and approved study plan for children, a so-called PIP (Paediatric Investigation Plan).

2019

Protocol approved by EMA Paediatric

Committee

IsoCOMFORT Study

• 160 children, aged 3 to 17

• Isoflurane via AnaConDa vs. IV Midazolam

• Sedation will last for 12-48 hours

• Primary endpoint: time with adequate sedation, assessed with the COMFORT-B scale

• Preliminary duration of trial: 18 months

• Finalisation of site feasibility assessment and CRO selection underway

Q22020

Planned recruitment of first patient

The outcome of the study is not a requirement for obtaining an authorization for use in adults, so the timetable for approval of IsoConDa is not affected by this decision.

Since the filed registration documentation will now be complete – i.e. also covers children –an approval means Sedana Medical will receive ten years of market exclusivity in Europe for

the use of isoflurane in sedation in intensive care.

24 |24 |

Combination registration of AnaConDa & IsoConDa in USA 4. Development & commercialisation

The FDA has accepted that Sedana Medical is taking the 505 (b) (2) path to registration, which somewhat simplifies the use of previously collected data.

PRE-IND NON-CLINICALCLINICALTRIALS

Randomized, double-blinded study

Randomized, double-blinded study

NDASUBMISSION

COMMER-CIALISATION300 - 550 patients in total

505 (b) (2) approval pathway

FDA positive about combined

registration

PRE-IND

NON-CLINICAL DATA

Current documentation to be complemented with more data, to be approved by FDA:

• Toxicity studies – animal and PPND*

• Human factors validation

CLINICAL STUDIES

Two clinical, randomized and double-blinded studies to be conducted to confirm and ensure efficacy and safety.

SAFETY DATABASE

Patients from these clinical studies, as well as patients from the European study will be included in the safety database of 500 isoflurane patients.

COMMERCIALISATION

Commercialisation strategy for USA –whether to launch ourselves or together with a local partner – to be decided around 2022.

* PPND: pre- and post-natal development.

25 |25 |

Combination registration of AnaConDa & IsoConDa in USA 4. Development & commercialisation

Key operational activities and collaborations

Director of clinical development for the US recruited.

Intend to set up a company in the US for management of studies, registration and market access.

Close cooperation with relevant consultants and US key opinion leaders.

Contract Research Organization for non-clinical studies.

Collaboration with academic centers in the US initiated for planning of clinical studies.

Collaboration with Harvard and HF consultant company for Human Factors Engineering Program.

26 |26 |

Timeline – registration activities in Europe and US

2019 2020 2021 2022 2023 2024

• February 2019 Paediatric study approved

• December 2019 Target inclusion of last patient in IsoConDa study around turn of the year

• Jan 2020 IsoConDa study completion

• Q2 2020 Paediatric study -first patient in

• Summer 2020Submit MAA application in 16 countries in a first round

• H2 2021 Completion of paediatric study

• H2 2021 Registration approval of IsoConDa

• March 2019 Pre-IND meeting with FDA

• August 2019 Pilot testing of non-clinical studies initiated

• June 2020Completion of Human Factors validation study

• Q4 2020 IND application

• 2021 IND approval and clinical studies begin

• 2022Decide whether to launch the products in US ourselves or together with a local partner

• 2023 NDA application

• 2024NDA approval expected

MAA Approval NDA Approval


27 |27 |

Japan

• Approval of AnaConDa in Japan in Q4 2018

• First patient treated in Q2 2019

• Investigating the possibility for registration of IsoConDa – Pre-IND meeting during H1 2020

China

• 10-year exclusive distribution agreement with Kyuan Xinhai Medical, a subsidiary of partly state-owned Shanghai Pharma, the second largest life science company in China

• Kyuan will immediately commence fast-track registration of AnaConDa

• Estimated time to approval is under two years, by latest 2021

India

• Exclusive distribution agreement with Hansraj Nayyar Medical

• Sales will commence in the fall 2019

• Registration process for AnaConDa will commence in parallel

Development highlights RoW4. Development & commercialisation

From proven therapy to approved standard of care

EUR 300mEstimated annual market potential

5-6mEstimated ventilation

days annually

2mEstimated ventilation

days annually

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Christer Ahlberg CEO

ᴏ CEO of Sedana Medical since 1 February, 2017

ᴏ Former CEO of Unimedic Group 2010–2016

ᴏ Former CEO of Eisai AB 2005–2010

ᴏ Christer also has over 10 years of experience in sales, marketing and market access positions from AstraZeneca, Meda and Wyeth

ᴏ Shareholding: 230,000 shares (1.16%)

Experienced management with proven track record5. Board & Management with extensive experience

Peter Sackey CMO

ᴏ Chief Medical Officer at Sedana Medical from Jan 2018

ᴏ Previous positions as Senior Consultant & Associate Professor at the Dept. of Intensive Care Medicine, Perioperative Medicine and Intensive Care, Karolinska University Hospital

ᴏ Over 20 years of clinical experience as an anesthesiologist and ICU physician

ᴏ One of the leading researchers in inhalation sedation in the world and was the first to use AnaConDa in intensive care

ᴏ Shareholding: 975 shares (<0.01%)

Maria Engström CFO

ᴏ CFO of Sedana Medical since February 2017

ᴏ Previous positions as Head of Cross Pharma AB 2015–2016 and Head of Business Control at Medivir 2012–2014

ᴏ Over 15 years experience from positions as Finance manager, Head of Business Control and Controller from Biovitrum, Bristol Myers Squibb and Ericsson


Robert vom Dorp Vice President Head of Sales

ᴏ Robert has been with Sedana Medical since January 2005

ᴏ Previous positions include Sales Manager for Stanley/DeWalt professional power tools and Area Sales Manager and Key Account Manager at HUDSON RCI / Teleflex Medical


Ron Farrell Vice President Head of R&D and Quality

ᴏ Operations Director with Sedana Medical since 2012

ᴏ MD at Kaymed 2009–2012

ᴏ Previous positions as Operations Director / Operations Manager with JnJ, Gillette, Artema Med’ and Tech Group

ᴏ Over 35 years Operational, Quality, Engineering, and Development Experience


Donat O’Brien General Manager - Manufacturing/Supply

ᴏ COO of Sedana since 2018

ᴏ Previous positions Include Director, Supply Chain at Mallinckodt Specialty Pharmaceuticals Ireland, Head of Supply Chain International at QuestcorPharmaceuticals and Commercial Services Manager at Aspen Pharmacare

ᴏ Over 20 years of experience in operational and strategic supply chain management

ᴏ Shareholding: -

30 |30 |

Diversified Board with extensive sector knowledge5. Board & Management with extensive experience

Thomas Eklund Chairman of the Board

ᴏ Chairman since 2014

ᴏ Thomas holds several Chairman of the Board positions in various companies, including Moberg Pharma

ᴏ He has vast experience from leading positions within the healthcare industry, for example as CEO and Head of Europe at Investor Growth Capital


Sten Gibeck Board Member

ᴏ Board member since 2005

ᴏ Former owner and CEO of Louis Gibeck AB during its journey from being a small distribution company to achieving a leading position in its field

ᴏ Sten was also previously Chairman of Sedana Medical and the European industry association Eucomed, which represents the medical technology industry in Europe

ᴏ Shareholding: 1,605,744 shares (8.09%)

Bengt Julander Board Member

ᴏ Board member since 2011ᴏ Bengt has more than 30 years of experience from the Life Science industryᴏ Currently the CEO of Linc, a private investment companyᴏ Shareholding: 2,116,901 shares (10.67%)

Mike Ryan Board Member


ᴏ Mike was CEO of Sedana Medical 2011-2017

ᴏ CEO of TecScan Ireland Ltd since 1990, and previously CEO/major shareholder of Artema until trade sale to Datascope 2003- 2007

ᴏ Board member of AIM listed Venn Life Sciences

ᴏ Founder Director of IRRUS angel investment syndicate


Ola Magnusson Board Member

ᴏ Board member since 2005ᴏ Ola has been with Sedana Medical since the foundation in 2005 and served as

CEO of the company until 2011ᴏ Ola has 25 years of experience from the pharmaceutical business in Pharmacia

and Kabi and 20 years of experience from the medical device industry in Louis Gibeck AB as CEO, Hudson RCI as Managing Director for EMEA


Eva Walde Board Member


ᴏ Recently VP Commercial Operations at Phadia / ThermoFisher Scientific.

ᴏ Previously leading positions in product management and market and strategy management within i.e. Hoechst, Bristol Myers Squibb, Pfizer and


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Financial highlights

Post-approval

50%

55%

60%

65%

70%

75%

80%

0

5 000

10 000

15 000

20 000

25 000

30 000

35 000

40 000

45 000

50 000Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 Q2-2019

KSE

K

Gross Profit, 12 months rolling

Gross Profit Gross Margin%

-15%

-10%

-5%

0%

5%

10%

15%

20%

25%

-10000

-5000

0

5000

10000

15000

20000

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

KSEK

EBITDA, 12 months rolling

EBITDA EBITDA %

6. Financial highlights

Q2 2019

• Net sales of 17,4 MSEK vs. 14,8 MSEK in Q2 2018, 20% growth individual quarter and 24% rolling 12 months.

• Gross margin of 13,4 MSEK or 77% vs. 11,3 MSEK or 78 % in Q2 2018.

• EBITDA -2,3 MSEK or -13,4% vs. -1,0 MSEK or -6,9% in Q1 2018.

• OPEX increased with 30% vs Q2 2018 due to build up of European organisation and preparation for IsoConDa launch which means continued sales and market investments during Q2.

• 40 employees in average in Q2 vs. 30 employees end of 2018 for the group in total.

• Cash flow from operations was -2,1 MSEK.

• Cash flow from investments was -13,4 of which -8,8 MSEK concern product development.

• Total cash flow for the group in Q2 was -12,6 MSEK.

All time high sales in 1HY 2019 EBITDA development

Gross margin development

• Close to 40% growth in France 1HY 2019 and significant sales increase in the UK and Nordics

33 |33 |

Financial results Q2 2019 vs. Q2 2018

(MSEK)

P&L Balance Sheet Cash Flow 2019 2018 2019 2018 2019 2018

Revenues ASSETS

Net sales 17,4 14,5 Intangible assets 72,7 38,3

Cash flow from operations bef.

change in w.c. -2,1 -0,4

Capitalized development expenses 0,0 0,0 Tangible assets 5,2 5,2

Other operating income 0,6 0,4 Financial assets 2,0 1,4 Change in w.c. 0,7 3,6

17,9 14,8 Total Fixed assets 79,8 44,9

Operating cost and expenses

Cash flow from operations after

change in w.c. -1,4 3,2

Cost of goods sold -4,0 -3,2 Inventory 5,8 4,9

External expenses -6,7 -5,5 Receivables 8,9 7,6 Cash flow from investment activities -13,4 -8,8

Personnel expenses -9,2 -6,8 Cash and cash equivalents 137,3 181,6

Depreciation and amortisation -1,0 -1,0 Total current assets 152,0 194,1 Cash flow from financing activities 2,2 108,0

Other operating expenses 0 0

Operating income -3,4 -2,0 TOTAL ASSETS 231,8 239,0 Cash flow for the period -12,6 102,3

Income from financial items EQUITY & LIABILITIES

Result from securities and long term

receivables 0,0 0,0 Share capital 2,0 1,9

Financial income 0,7 1,3 Other equity 212,1 221,7

Financial expenses 0,2 -0,9 Total equity 214,1 223,6

Income after financial items -2,5 -1,6

Long term liabilities 0,0 0,0

Income before taxes -2,5 -1,6

Current liabilities 17,8 15,4

Taxes 0,8 0,8

Net Income -1,7 -0,8 TOTAL EQUITY AND LIABILITIES 231,8 239,0

Q2 30 June Q2


34 |34 |

Largest shareholders at the end of June 2019

Number of

shares

Share

(%)

Linc AB 2 116 901 10,78%

Sten Gibeck 1 605 744 8,33%

Handelsbanken funds 1 514 903 7,71%

Anders Walldov direct and indirect

(Brohuvudet AB)1 400 000 7,13%

Ola Magnussion direct and indirect

(Magiola AB)1 340 867 6,83%

Anades Ltd. 1 068 083 5,44%

Ron Farrell 731 062 3,72%

Berenberg funds 712 731 3,63%

Alfred Berg funds 476 648 2,43%

Nordnet Pension Insurance 470 022 2,39%

Swedbank Robur funds 450 000 2,29%

Eklund Konsulting AB 416 616 2,12%

Tony McCarthy 339 823 1,73%

Philip Earle 304 751 1,55%

Alto Invest SA 271 375 1,38%

Fifteen largest shareholders 13 219 526 67,32%

Others * 6 417 065 32,68%

Total 19 636 591 100,00%

* CEO's ownership is 230 000 shares.


35 |35 |





Appendix



TABLE OF CONTENTS

OFFON

A

36 |36 |

Patient case study: James Spiegel – October 2017

“I am not a doctor but I believe if this were available to me earlier, things would not have been as serious”

“I will always be an advocate for Sedana Medical as this device saved not only my life but saved severe grief to my girlfriend and families lives as well. I believe that there needs to be more awareness about this device and its benefits. We need to challenge conventional treatment as I strongly believe that if this had happened in the United States I would not have survived.”

Back in the gym four weeks laterUpon discharge I had a long discussion with the head of the ICU whom disclosed that prior to the AnaConDa being connected, he believed I had approximately 10 hours left before he would have had to make some tough calls. I have no words to describe the gratitude I have to the team at Sedana Medical, whom even after I had woken up went above and beyond to check on my health status.

“Following a trip to the Dead Sea I decided to take a nap to recover from a long trip; it was a nap I almost did not wake up from”

I passed out and subsequently had to be resuscitated in the ambulance. Once at the hospital the physicians had to put me in a medical induced coma for almost 11 days. Throughout this period the hospital attempted all conventional treatments such as propofol resulting each time in a worsening of my condition, as my Co2 markers were at a hazardous level. At this point, my family was called because they could not find an effective treatment. The next step would have been a heart and lung machine, which the physicians believe I would not have survived.

The head of the department had one AnaConDa device which he had obtained as a sample, but had no accessories or follow up product and said that would be the last treatment he could try. My partner contacted Sedana Medical and explained the situation to them, briefing them on exactly what was happening. The Sedana Medical team in Germany arranged to meet her the following day in Frankfurt to provide her with product. Upon getting there they were very understanding and compassionate about my situation and made sure she had the correct product and necessary accessories to return to Israel with, to save my life. Upon return the hospital physicians quickly set up the AnaConDa delivery system and within a few hours my vitals began to stabilize and they were able to wake me up.

A. Appendix

37 |37 |

Select PublicationsGeneral1. Karnjuš, Igor, Dušan Mekiš, and Miljenko Križmarić. "Inhalation sedation with the ‘Anaesthetic Conserving Device’for patients in intensive care units: A literature

review." Signa vitae: journal for intesive care and emergency medicine 11.1. (2016): 1-24.2. Jerath, Angela, et al. "Volatile anesthetics. Is a new player emerging in critical care sedation?." American journal of respiratory and critical care medicine 193.11

(2016): 1202-1212.3. Lopez-Ramos, Jose M., et al. "Sevoflorane as adjuvant for sedation during mechanical ventilation in intensive care unit medical patients: Preliminary results of a

series of cases." Colombian Journal of Anesthesiology 44.1 (2016): 52-57.4. Bellgardt, Martin, et al. "Survival after long-term isoflurane sedation as opposed to intravenous sedation in critically ill surgical patients: retrospective

analysis." European Journal of Anaesthesiology (EJA) 33.1 (2016): 6-13.

Cardio1. Krannich, Alexander, et al. "Isoflurane sedation on the ICU in cardiac arrest patients treated with targeted temperature management: an observational propensity-

matched study." Critical care medicine 45.4 (2017): e384-e390.2. Jerath, Angela, et al. "Volatile-based short-term sedation in cardiac surgical patients: a prospective randomized controlled trial." Critical care medicine 43.5 (2015):

1062-1069.3. Hellström, Jan, et al. "Inhaled isoflurane sedation during therapeutic hypothermia after cardiac arrest: a case series." Critical care medicine 42.2 (2014): e161-e166.4. Steurer, Marc P., et al. "Late pharmacologic conditioning with volatile anesthetics after cardiac surgery." Critical Care 16.5 (2012): R191.

Pulmonary1. Meiser, Andreas, et al. "Inhaled sedation in patients with acute respiratory distress syndrome undergoing extracorporeal membrane oxygenation." Anesthesia &

Analgesia 125.4 (2017): 1235-1239.2. Jabaudon, Matthieu, et al. "Sevoflurane for sedation in acute respiratory distress syndrome. A randomized controlled pilot study." American journal of respiratory

and critical care medicine 195.6 (2017): 792-800.3. Ferrando, Carlos, et al. "Sevoflurane, but not propofol, reduces the lung inflammatory response and improves oxygenation in an acute respiratory distress syndrome

model: a randomised laboratory study." European Journal of Anaesthesiology (EJA) 30.8 (2013): 455-463.4. Laufenberg, M., and T. Schneider. "Severe exacerbation of COPD requiring ventilation: Use of vv-ECMO combined with inhalation anesthetics." Medizinische Klinik,

Intensivmedizin und Notfallmedizin 112.4 (2017): 352-355.

Neuro1. Purrucker, J. C., et al. "Volatile sedation with sevoflurane in intensive care patients with acute stroke or subarachnoid haemorrhage using AnaConDa®: an

observational study." BJA: British Journal of Anaesthesia 114.6 (2015): 934-943.2. Gumbinger, Christoph, et al. "Administration of isoflurane-controlled dyskinetic movements caused by anti-NMDAR encephalitis." Neurology 80.21 (2013): 1997-

1998.3. Bösel, Julian, et al. "Volatile isoflurane sedation in cerebrovascular intensive care patients using AnaConDa®: effects on cerebral oxygenation, circulation, and

pressure." Intensive care medicine 38.12 (2012): 1955-1964.

A. Appendix

38 |38 |

Sources1. Figures based on three sources: Society of Critical Care of Medicine (20-30% in the US), International Comparison in Critical Care (53.7%) and Review for the NHS Executive of Adult Care Services: An International

(42-60% for seven European countries)

2. Röhm KD, Wolf MW, Schöllhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the anaesthetic conserving device after cardiothoracic surgery. Intensive Care Med. 2008;34(9):1683-1689

- Mesnil M, Capdevila X, Bringuier S, et al. Long-term sedation in intensive care unit: A randomized comparison between inhaled sevoflurane and intravenous Propofol or midazolam. Intensive Care Med.

2011;37(6):933-941

- Hanafy MA. Clinical evaluation of inhalational sedation following coronary artery bypass grafting. Egypt J Anaesth. 2005;21(3):237-242

- Sackey P V, Martling C-R, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med., 2004;32(11):2241-2246.

- Shelly MP, Sultan MA, Bodenham A, Park GR: Midazolam infusions in critically ill patients. Eur J Anaesthesiol 1991, 8: 21-27

3. Röhm KD, Wolf MW, Schöllhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the anaesthetic conserving device after cardiothoracic surgery. Intensive Care Med. 2008;34(9):1683-1689

- Mesnil M, Capdevila X, Bringuier S, et al. Long-term sedation in intensive care unit: A randomized comparison between inhaled sevoflurane and intravenous Propofol or midazolam. Intensive Care Med.

2011;37(6):933-941

4. Bellgardt, M., Bomberg, M., Dasch B. et al, Survivial after long-term isoflurane sedation as opposed to intravenous sedation in cirtically ill surgical patients, Eur J Anaesthesiol 2015; 32:1-8

5. Sackey P V, Martling C-R, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med., 2004;32(11):2241-2246.

6. Sackey, Peter V., et al. "Short-and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam—A pilot study." Critical care medicine 36.3 (2008): 801-806.

7. Englert, J. A., Macias, A.A., Amandor-Munoz, D., Isoflurane Ameliorates Acute Lung Injury by Preserving Epithelial Tight Junction Integrity, Crit Care Med, Anesthesiology 2015; 123:00-00.

8. Rooke, GA., Choi JH., Bishop, MJ.: The effect of isoflurane, halothane, sevoflurane, and thiopental/nitrous oxide on respiratory system resistance after tracheal intubation, 1997 Jun;86(6):1294-9

10. Spencer et al. Intensive Care Medicine 1992;18(7):415-21

- Kong et al. BMJ 1989 13;298(6683):1277-80

- Hendrickx et al. J of Clin Monit Comput 2018;32(4)

11. Voigtsberger et al. Anesthesiology 2009;111:1238-48.

- Ferrando et al. Eur J Anesthesiology 2013;30:455–63.

- Jabaudon et al. Am J of Resp Critic Care Med 2017;195(6),792-800

- Shankar et al, Intensive Care Med 2006;32;927-933

- Turner et al, Respiratory Care 2012;57(11):1857-64

12. Sackey P V, Martling C-R, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med., 2004;32(11):2241-2246.

- Mesnil et al. Intensive Care Med 2011;37:933–41

- Krannich et al, Critical Care Med 2017;45(4):e384-e390

A. Appendix

39 |39 |

Sources cont’d13. Mesnil M, Capdevila X, Bringuier S, et al. Long-term sedation in intensive care unit: A randomized comparison between inhaled sevoflurane and intravenous Propofol or midazolam. Intensive Care Med.

2011;37(6):933-941

- Sackey, Peter V., et al. "Short-and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam—A pilot study." Critical care medicine 36.3 (2008): 801-806.

- Sackey P V, Martling C-R, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med., 2004;32(11):2241-2246.

- Krannich et al, Critical Care Med 2017;45(4):e384-e390

- Voigtsberger et al. Anesthesiology 2009;111:1238-48.

- Ferrando et al. Eur J Anesthesiology 2013;30:455–63.

- Jabaudon et al. Am J of Resp Critic Care Med 2017;195(6),792-800

- Shankar et al, Intensive Care Med 2006;32;927-933

- Turner et al, Respiratory Care 2012;57(11):1857-64

14. Bittner M-I, Donnelly M, van Zanten AR, et al. How is intensive care reimbursed? A review of eight European countries. An Intensive Care. 2013;3:37

15. Barr, Juliana, et al. "Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit." Critical care medicine 41.1 (2013): 263-306.

16. O’Gara et al. Intensive Care Med 2016;42:1487–9.

17. Voigtsberger et al. Anesthesiology 2009;111:1238-48

18. Ferrando et al. Eur J Anesthesiology 2013;30:455-63.

19. Jabaudon et al. Am J of Resp Critic Care Med 2017;195(6),792-800

20. Shankar et al, Intensive Care Med 2006;32;927-933

21. Turner et al, Respiratory Care 2012;57(11):1857-64

A. Appendix

Documents

MANAGEMENT PRESENTATION - Sedana Medical · This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend