management presentation ceo christer ahlberg th of september … medical.pdf · a global standard...

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Management Presentation

CEO Christer Ahlberg

6th of September 2018

STRICTLY PRIVATE AND CONFIDENTIAL

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52%Sales growth Q2 2018

vs Q2 2017

26%Sales growth2017 vs 2016

From proven therapy to approved standard of care

• Current Intensive Care Unit (ICU)sedation has many issues

• Inhalation Sedation has inherent benefits

– But still Off-Label in ICU

• Sedana Medical and its productsAnaConDa and future IsoConDa is:

– Leading and Uniquely positioned to enable the use of Inhalation Sedation in ICUs globally

– Proof of concept in Germany, > 500 clinics.

– Ongoing clinical registration study in EU

– USA registration work in progress.

• Market potential: 10-20 BSEK

• Vision:Inhalation sedation with AnaConDa and IsoConDa; a global standard of care therapy for mechanically ventilated ICU patients.

EXECUTIVE SUMMARY CURRENT PROGRESS

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Introduction


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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

Around 50% of ventilated patients require ventilation over 24h2

Patients require 5 days of ventilation on average

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

Sedation allows patients to be comfortable lying in the same position for prolonged periods of time

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


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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/delirium7

INTRAVENOUS SEDATION

Level of sedation difficult to monitor

Tolerance, withdrawal symptoms or agitation/delirium (20-35% of cases)4

Significantly increasing ICU stay (by up to 40%)

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)3

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

High mortality5

In long-term ventilated patients

Reduced mortality5

In long-term ventilated patients

Significantly reduced wake-up time (10-20 min)6

Improving the planning of clinical workflow and reducing time to extubation

Controlled sedation depth

With less under and over sedation


+

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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 have not been used in the intensive care unit setting 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 low cost 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 sedative 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® (Isoflurane)

- Significant reduction in mortality5

- 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 properties8

- 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.9

- Analgesic effect: Reduces the need for analgesics such as

remifentanil and other opioids by over 35% compared to when

using IV sedation, with benefits to the associated cost of sedation10

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

- Well documented safety and efficacy profile with >95

publications evaluating AnaConDa in combination with different

volatiles published since 2004.

* Based on studies performed on mice.


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IsoConDa® provides clear benefits over current standard of care

IsoConDa® IV sedationBenefit

Significantly reduced wake-up time3 10-20 min 90 min – 130 h

Significantly reduced time to extubation (ventilator tube removal)3 10-35 min 150-600 min

Tendency to limit the occurrence of hallucination episodes/delirium7 2 of 10 patients 5 of 7 patients

Reduction in use of opiates10 2.7 mg/hour 4.2 mg/hour

Reduced in-hospital mortality in long-term ventilated patients (>96h)5 40% 63%

Reduced 1 year mortality in long-term ventilated patients (>96h)5 50% 70%

Price per day SEK 1,000* SEK 200-3,000**

* Price for both AnaConDa and IsoConDa together. ** 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.

Reduction in ICU stay duration for deep sedation patients11 4-16 days 6-27 days

SEK 10-30kDaily cost of an

ICU bed in Europe12 $4-16bnAnnual cost of delirium

from ventilated patients in the US13


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Strong order development despite off-label status

Off-label definition

Isoflurane is not yet approved for inhalation sedation

Marketing restrictions

Interest customers from many markets

… despite off-label status limiting selling effortsRapidly increasing adoption and usage of AnaConDa…


AnaConDa usage in key market (Germany):

Clinics actively using AnaConDa

Crowded AnaConDa symposiumIn Bremen congress in Germany

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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% 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.


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.

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Development highlights

EUROPE

AnaConDa

CE mark received in 2003 and patent possible until 2036

Full approvalSedana Medical will apply for approval of the combination product (AnaConDa and IsoConDa) for the EU market

Ongoing registration activities• CTD components in preparation• Genotox/carcinogenicity report complete• Pediatric RCT plan submitted to EMA

• Study start in 2020

Market authorization expected in 2020



IsoConDa study

Phase III registration study initiated with 1st patient in Q2 2017 and full 10-years exclusive from registration.

IsoConDa study status

• Reactivation of emergency patient inclusion

• Five new sites entering study in Q2-Q3• Blinded interim analysis of variance Q4

2018 - determines final sample size (300-550)

• Next study update in Q4 2018/Q1 2019

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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 ENDPOINT

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


INTERIM ANALYSISbefore year-end 2018

2. Development of registration work in the United States with both AnaConDa and IsoConDa.

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US

US full approval of AnaConDa and IsoConDa

• Sedana Medical has started the US registration work • Advisory meeting with US regulatory agent and US clinicians/researchers August

2018• Request for FDA meeting around the turn of year 2018/19• The meeting with FDA will determine what further study and documentation will be

required for USA registration• Information regarding requirements and time-plan will be communicated in early

2019

Time for projected market authorization communicated after FDA meeting



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

52%Sales

increase

vs. Q2 2017

0

10 000

20 000

30 000

40 000

50 000

60 000

Jul Aug Sep Okt Nov Dec Jan Feb Mar Apr May Jun

KSE

K

Sales revenues, 12 months rolling

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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


Germany: Growing, stands for 86% of total sales. >500

clinics using AnaConDa regularly. Participating in German

Anaesthesia Congress, DAC 2018

France: Growing and now with 3 KAMs employed the

number of clinics using AnaConDa will increase. Many

ICUs are planned for training during the coming year.

Nordic: Sedana Medical started its own sales operations

recently. During Q2 clinics in Sweden and Norway have

been trained in inhalation sedation treatment with

AnaConDa.

UK/Ireland: Direct sales set-up from July 1st 2018 and

employees from October 1st. Preparing HE-Package

Spain: Growing, even though only 1 KAM. Currently

approx. 15 clinics using AnaConDa.

Distributor markets:

Going from passive distributor management to active.

Interest from many eastern European markets.

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RoW

AnaConDa

Approved in Canada, Russia, Australia and South Korea

The South Korean distributor supplied for Reimbursement in Q3 2017

Japanese distributor applied for registration of AnaConDa in Japan in November 2017

Investigating China possibilities

Investigating possibilities in Middle East



Financial highlights

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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

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Financial highlights

High and improving gross margin

EBITDA development

Post-approval


• Net Sales 14,5 MSEK vs. 9,5 MSEK in Q2

2017, 52% growth.

• Gross Margin 11,3 MSEK or 78% vs. 7,4

or 77 % in Q2 2017

• EBITDA -1,0 MSEK or -6,9% vs. 673 or

7,1% in Q2 2017.

• Cash flow from operations was 3,2 MSEK.

• 7,1 MSEK investment in development

expenses was capitalized during Q2 2018.

• Build up of European sales organisation,

25 employees Q2 2018 vs. 17 employees

Q2 2017 for the group in total.

• Continued sales and market investments

during Q2 with many local exhibitions

and symposia.

Q2-2018

-5,0%

-4,0%

-3,0%

-2,0%

-1,0%

0,0%

1,0%

2,0%

3,0%

4,0%

-1 500

-1 000

-500

0

500

1 000

1 500

2014 2015 2016 2017

KSE

K

EBITDA and EBITDA %

EBITDA EBITDA %

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

70,0%

80,0%

0

5 000

10 000

15 000

20 000

25 000

30 000

35 000

2014 2015 2016 2017

KSE

K

Gross profit and Gross Margin %

Gross Profit Gross Margin %

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Largest shareholders at the end of June 2018

Completed directed new share issue June the 5th of MSEK 112 directed to institutional investors. The purpose is to initiate the registration process of AnaConDa and IsoConDa in the U.S, and to further accelerate the commercialization in Europe.

Examples of investors: • Handelsbanken Fonder, • Norron Asset Management,• Alfred Berg Kapitalförvaltning,• Swedbank Robur • Cliens Kapitalförvaltning• Institutions in Germany, UK & Finland

Questions

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Table of contents

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

4Regulatory approval to enable marketing and provide market exclusivity

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

6 Financial highlights and Post IPO

A Appendix

1 Introduction

AnaConDa and IsoConDa – A superior combination for ICU sedation2


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Maria Engström CFO

ᴏ CFO of Sedana Medical since February 2017

ᴏ Previous positions: Head of Cross Pharma AB 2015–2016,

ᴏ Head of Business Control at Medivir 2012–2014.

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

Robert Vom Dorp Commercial Director

ᴏ Robert has been with Sedana Medical since January 2005

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

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 more than 10 years of experience in sales, marketing and market access positions from AstraZeneca, Medaand Wyeth

ᴏ Shareholding: 260,000 shares (1.50%)

Peter Sackey CMO

Ron Farrell COO Operations / R&D / Quality

ᴏ Chief Medical Officer at Sedana Medical from Jan 2018

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

ᴏ More than twenty years’ 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 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


Experienced management with proven track record

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Diversified Board with extensive sector knowledge

Bengt Julander Board Member

ᴏ Board member since 2011

ᴏ Bengt has more than 30 years of experience from the Life Science industry

ᴏ Currently the CEO of Linc, a private investment company

ᴏ Shareholding: 1,821,901 shares (10.54%)

Sten Gibeck Board Member


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


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


Ola Magnusson Board Member

Mike Ryan Board Member


ᴏ Ola has been with Sedana Medical since the foundation in 2005 and served as CEO of the company until 2011

ᴏ 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



ᴏ Mike was CEO of Sedana Medical 2011-2017

ᴏ Previously CEO / major shareholder of Artema 2003 until trade sale to Datascope in 2007

ᴏ CEO of TecScan Ireland Ltd since 1990

ᴏ Board member of AIM listed Venn Life Sciences

ᴏ Founder Director of IRRUS angel investment syndicate



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

ᴏ Shareholding: 0 shares

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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. Company estimates based on data from Svenska Intensivvårdsregistret (2013)

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

- 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

4. 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

5. 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

6. 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.

7. 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.

8. 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.

9. 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. Meiser, Andreas, and H. Laubenthal. "Inhalational anaesthetics in the ICU: theory and practice of inhalational sedation in the ICU, economics, risk-benefit." Best practice & research Clinical anaesthesiology 19.3

(2005): 523-538.

- 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.

11. 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 (2017)

12. 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

13. 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.

14. EU market size:IMS Health Pharmaceutical Sales Statistics EU 2016, US 2012. US market size is a company estimate based on IMS Health statistics 2014 sales data for Precedex quoted by Orion in 2015 Results

Presentation.

15. Prices based on data from Stockholms Läns Landsting , april 2017. and amounts based on data from “Dexmedetomidine for Sedation in the ICU or PICU: A Review of Cost-Effectiveness and Guidelines, Canadian

Agency for Drugs and Technologies in Health; 2014 Dec.” The company estimates that prices in Sweden are lower than in the rest of Europe

16. Dexmedetomidine for Sedation in the ICU or PICU: A Review of Cost-Effectiveness and Guidelines, Canadian Agency for Drugs and Technologies in Health; 2014 Dec. US prices based on data from

http://www.empr.com/diprivan/drug/3699/


management presentation ceo christer ahlberg th of september … medical.pdf · a global standard...

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