MANAGEMENT PRESENTATION - SEPTEMBER 2019 MANAGEMENT PRESENTATION - Sedana Medical AB
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MANAGEMENT PRESENTATION
September 2019
SEPTEMBER 2019
MANAGEMENT PRESENTATION
1|
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.
2|
ENABLING INHALATION SEDATION COMPANY IN BRIEF
1. Current ICU sedation presents many challenges, uncertainties and • Sedana Medical is a Swedish MedTech company on its way to
risks. becoming a pharmaceutical company.
2. Inhalation sedation has many inherent benefits, but has not been • AnConDa enables inhalation sedation of mechanically ventilated
practically possible in the past. patients in intensive care.
3. Sedana Medical is uniquely positioned to enable inhalation • AnaConDa administers the volatile drug IsoConDa (isoflurane) via
sedation in ICUs globally. the respiratory tract in an efficient, safe, simple and cost-effective
4. Sedana Medical has demonstrated proof of concept with rapidly manner.
growing adoption despite off-label status. • AnaConDa is approved in Europe, South Korea, Japan and a
5. Sedana Medical sees blockbuster potential for AnaConDa & number of other countries.
IsoConDa. • Positive Pre-IND FDA interaction to combination registration of
6. Phase III clinical trial of IsoConDa ongoing with study completion AnaConDa and IsoConDa through the 505 (b) (2) pathway.
estimated for January 2020. • MAA approval expected 2021 and NDA approval expected 2024.
Global market Sales Sales growth
EUR 2-3bn EUR 5.5m 24%
annually (estimated) 2018 RTM June 2019
VISION
“Inhalation sedation is a potential paradigm shift in
Inhaled sedation with AnaConDa & IsoConDa: intensive care.”
A global standard of care therapy for – Professor Daniel Talmor, anaesthesiologist and
mechanically ventilated ICU patients. physician at Beth Israel Deaconess Medical Centre
3|
A. Appendix
History of Sedana Medical
First cost consequence
analysis presented
AnaConDa first Proving cost-effectiveness of
Inititation of AnaConDa vs IV -sedation
used
Registration
in Sweden in the mid Reduced ICU Stays
90's and tested in a
Reduced Mortality Study
Study shows that short-term Study finds that one year
clinical setting for the
first time in 1999
sevoflurane sedation using mortality is significantly First sales in the UK
AnaConDa after cardiothoracic lower in isoflurane vs. IV Direct sales with
surgery significantly reduces sedatated patients first hire in the UK
First study ICU stay, venillation time and Approval and Sales
of inhalation hospital stay
sedation using Company Founded of AnaConDa-S
isoflurane in Uppsala Sweden (50ml) in EU
Kong et al. 1988 New ICU Sedation
Guidelines
For the first time Approval of AnaConDa Approval of
Inhalation Sedation is in S.Korea as first AnaConDa in
part of the new ICU country in Asia Japan
First AnaConDa sales Sedation guidelines in
Sedana establishes test Germany
market in Germany
Listed at Nasdaq
First North
Stockholm
1988 1999 2005 2007 2008 2010 2015 2017 2018
4|
TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
2 AnaConDa & IsoConDa – a superior combination for ICU sedation
Large & clearly defined market opportunity for replacement of
3 standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in
5 commercialisation of medtech and pharmaceutical products
6 Financial highlights
A Appendix
5|
1. Sedation in ICUs represents a large unmet clinical need
Intensive care units and sedation: A brief introduction
Overview: Intensive care units Why are patients sedated in the ICU?
INTENSIVE CARE UNIT (ICU) SEDATION IN THE ICU
ICUs cater to critically ill patients with severe illnesses and injuries 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
Common conditions treated at ICUs include: anxiety and distress to facilitate safety by:
Trauma, multiple organ failure, sepsis and acute respiratory distress syndrome Reducing autonomic stress, optimising ventilator treatment - asynchrony and avoiding
self-extubation
30-50% of patients require mechanical ventilation to breathe1 Sedated patients are better able to tolerate many of the
procedures performed during ICU care
6|
1. Sedation in ICUs represents a large unmet clinical need
Sedation in the ICU represents a large unmet clinical need
Current sedation methods fall short on key factors A better sedative exists but it hasn’t been possible to use
INTRAVENOUS SEDATION INHALATION SEDATION
Long and unpredictable wake-up times (90 min – 130 h)2 Significantly reduced wake-up time (10-20 min)5
Improving the planning of clinical workflow and reducing time to extubation
Prolonging the stay in the ICU and making extubations difficult to plan
Controlled sedation depth
Drug level concentration is difficult to monitor
With less under and over sedation
Tolerance, withdrawal symptoms or agitation/delirium (20-35% of cases)3
Significantly increasing ICU stay (by up to 40%) Tendency to reduce hallucination episodes/delirium 6
Delirium increases the mortality risk significantly
Eliminated through the liver or kidneys Eliminated through the lungs
Extra burden on liver/kidneys. ICU patients frequently have impaired organ function Inhaled sedatives such as Isoflurane are almost entirely eliminated through the lungs
High mortality4 Reduced mortality4
In long-term ventilated patients In long-term ventilated patients
7|
1. Sedation in ICUs represents a large unmet clinical need
Inhalation sedation hasn’t been practically possible in the past
The tools for administration exist but not for use in the ICU AnaConDa finally makes inhalation sedation possible in the ICU
ANESTHESIA MACHINE ANACONDA
Anesthesia machines are used for administration of general AnaConDa is a cost-effective CE marked disposable system for the
anaesthesia in the operating room. delivery of inhaled sedatives built for use in the ICU.
These machines are capable of inhalation sedation, however, they By incorporating a vaporizer, circle system, heat & moisture
are not approved or intended for use in the intensive care unit exchanger and a bacterial/viral filter into a single disposable
setting and they are not used due to their size and high capital device AnaConDa is able to make inhalation sedation possible and
and usage costs making them unsuitable for prolonged use. practical in the ICU.
The additional need for administration and monitoring by a The AnaConDa device is simply attached to a traditional ICU
specialist makes the use of these machines labour intensive and ventilator in order to deliver controlled sedation to patients.
impractical for inhalation sedation.
8|
1. Sedation in ICUs represents a large unmet clinical need
AnaConDa – making inhalation sedation possible in the ICU
Compact device encompassing the most important elements of an anaesthesia machine for ICU use
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
Vaporizer Heat & moisture Circle system Bacterial/Viral filter
exchanger - CE marked with strong sales growth in Europe, patent possible until
2036
9|
1. Sedation in ICUs represents a large unmet clinical need
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 mortality4
- Potential for reduced ICU stay duration: No development of
IsoConDa®
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
- IsoConDa® (Isoflurane) is a generic volatile anaesthetic with a long record of use in the
operating theatre
- Reduction of opiate dependency: Reduces the need for analgesics
- Currently not approved for use as a sedative in the ICU setting but is used off label
such as remifentanil and other opioids by >35% compared to when
together with AnaConDa
using IV sedation, with benefits to the associated cost of sedation9
10 |
* Based on studies performed on mice.TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
AnaConDa & IsoConDa – a superior combination for ICU
2 sedation
Large & clearly defined market opportunity for replacement of
3 standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in
5 commercialisation of medtech and pharmaceutical products
6 Financial highlights
A Appendix
11 |1. Sedation in ICUs represents a large unmet clinical need
What do we expect from a modern ICU sedative?
Potential issues, challenges and side-effects
with IV sedation in ICU
1. Accumulation Modern ICU sedative requirements
• Long half-life – context sensitive half-life period
2. Metabolism and metabolites 1 Minimal accumulation
• High organ metabolism through liver or kidney
• ICU patients frequently have impaired organ function
• Active metabolites 2 Minimal metabolism and no active metabolites
3. Wake up times
• Long and unpredictable wake up times
• Extubation difficult to plan 3 Rapid on- and offset
• Prolonging the stay in the ICU
4. Adverse effects
4 Few adverse effects
• Withdrawal symptoms/hallucinogenic effects
• Delirium
• Interaction with other drugs
5 Readable drug level concentration
• Dependency/tolerances (tachyphylaxis)
• Propofol infusion syndrome
5. Sedation depth
• No monitoring of drug level
Volatile anaesthetics have been proposed as ideal ICU sedatives10
Sedation with volatile anaesthetics = Inhaled sedation
12 |2. AnaConDa & IsoConDa – a superior combination for ICU sedation
Sedana Medical has over a decade of clinical experience
More than 90 peer-reviewed publications
T
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rchw ell · p er io d. R en t in ar terial o f as thmaticu nal management.
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and a red on dioxide (PaC was sus- iratory fa
See Appendix for list of select publications.
e C ar di at ri al ca rb ef fe ct K ey w ords Resp s · Pediatrics ·
Mon ro
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anderbilt lle e 11 instan d le Status as2. AnaConDa & IsoConDa – a superior combination for ICU sedation
Therapeutical benefits by using inhaled anaesthetics
✓ Improved oxygenation
Pulmonary therapeutic effects for patients
✓ Reduction of pulmonary inflammatory response
with impaired gas exchange11 ✓ Bronchodilatory effect
✓ Shorter time to extubation…
On-off effects and reliable wake-up with ✓ Shorter time to cooperation…
inhaled sedation12 ✓ Shorter ventilator time and ICU stay…
…when compared with intravenous sedation
✓ Works in all patients – full range sedative
✓ No need for polypharmacy
✓ Few problems after wake-up
Reliable effect and safety with inhaled
✓ Patients are more lucid and calm with less hallucinations and delusions
sedation for the distressed patient13 ✓ No/low risk of tolerance development, ceiling effect and withdrawal
symptoms
✓ Reduction of opioid use
14 |2. AnaConDa & IsoConDa – a superior combination for ICU sedation
IsoConDa® provides clear benefits over current standard of care
Benefits IsoConDa® IV 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***
Daily cost of an Annual cost of delirium
EUR 1-3k ICU bed in Europe14 $4-16bn from ventilated
patients in the US15
15 |
* 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.2. AnaConDa & IsoConDa – a superior combination for ICU sedation
A potential paradigm shift in intensive care
“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
16 |TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
2 AnaConDa & IsoConDa – a superior combination for ICU sedation
Large & clearly defined market opportunity for
3 replacement of standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in
5 commercialisation of medtech and pharmaceutical products
6 Financial highlights
A Appendix
17 |3. Large & clearly defined market opportunity for replacement of standard of care
Blockbuster market potential for IsoConDa/AnaConDa
Breakdown: total market potential for IsoConDa/AnaConDa*
Annual number of patients visiting the ICU Regional market potential
30 million
Europe USA
12 million
patients require mechanically ventilation
~7,5m
ICU patients
~7m
ICU patients
Ventilated and sedated patients
8 million
~EUR 700m ~EUR 900m
European market
US market potential
potential
Average number of sedation days depending on pricing
2,5-5 days
X
Asia/Pacific
AnaConDa/IsoConDa price per day in
Europe (will be higher in the US and
lower in Asia)
EUR 100 ~12,5m
ICU patients
X
AnaConDa/IsoConda market potential
EUR 2-3 billion
~EUR 1bn
Asian/Pacific
market potential
18 |
*Market size based on company estimates.3. Large & clearly defined market opportunity for replacement of standard of care
Rapidly increasing adoption and usage despite off-label status
Case study: AnaConDa in Germany Increasing use globally
• 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.
24%
AnaConDa in Germany Sales growth,
rolling 12 months
June 2019
Current use of AnaConDa
~600 Proven in clinical practice
ICUs use AnaConDa
>300,000
AnaConDa units sold
5% Clinics actively
of total market potential using AnaConDa >500,000
treatment days
19 |TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
2 AnaConDa & IsoConDa – a superior combination for ICU sedation
Large & clearly defined market opportunity for replacement of
3 standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in
5 commercialisation of medtech and pharmaceutical products
6 Financial highlights
A Appendix
20 |4. Development & commercialisation
Strategic priorities and financial targets
Strategic priorities Financial targets
Development and commercialisation: Europe
1 • Registration of the pharmaceutical candidate IsoConDa
(isoflurane) in 2021
During the period up until the approval of
• Ensure solid growth of AnaConDa sales and prepare for
Pre- IsoConDa is obtained, the Company's goal is to
launch of IsoConDa in 2021 registration increase sales with an average of over 20 per cent
per year, in parallel to building up a larger sales
Development and commercialisation: USA and market organization.
2 • Development of registration work in USA with both
AnaConDa and IsoConDa for NDA approval in 2024
• Commercialisation strategy for USA to be decided ~2022.
Provided that an approval of IsoConDa in Europe
Development and commercialisation: RoW Post- is obtained, the Company’s target is to reach a
3 • Register AnaConDa and IsoConDa in relevant markets in turnover in EU exceeding 500 million SEK and an
Asia, such as Japan and China registration EBITDA margin of 40 percent three years after
approval.
21 |4. Development & commercialisation
European market registration study – the IsoConDa study
Phase III trial: Non-inferiority study of IsoConDa compared to propofol
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.
First patient included IsoConDa (N=150) PRIMARY ENDPOINT
Study
completion Non-inferiority: proportion of time with
Q2 300 patients in total 48 ± 6h 24 hr, 7 & 30 days
treatment follow-up Jan 2020 adequate sedation depth for isoflurane
2017
compared to propofol
Propofol (N=150)
MAA SECONDARY ENDPOINTS
Submission
Summer Wake-up times, proportion of time with
2020
spontaneous breathing, opiate
requirements, ventilator-free days
After 12-16
months
RECRUITMENT STUDY SITES EXPLORATORY ENDPOINTS
Market authorization
• 234 patients recruited expected in EU (2021) Differences in Sequential Organ Failure
• Last patient in during the turn of the Assessment, mortality rate in addition to
year 2019/2020 21 German sites IsoConDa and AnaConDa specific
3 Slovenian sites endpoints
22 |4. Development & commercialisation
The IsoCOMFORT study for EU and USA
Approved paediatric investigation plan
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).
Protocol approved IsoCOMFORT Study Planned recruitment
by EMA Paediatric • 160 children, aged 3 to 17 of first patient
Committee
• Isoflurane via AnaConDa vs. IV Midazolam
• Sedation will last for 12-48 hours Q2
~18 Sites in Spain,
2019
• Primary endpoint: time with adequate 2020 Germany, France & Sweden
sedation, assessed with the COMFORT-B scale
• Preliminary duration of trial: 18 months
• Finalisation of site feasibility assessment and
CRO selection underway
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.
23 |4. Development & commercialisation
Combination registration of AnaConDa & IsoConDa in USA
505 (b) (2) approval pathway
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.
FDA positive
about combined
registration Randomized,
double-blinded study
CLINICAL NDA COMMER-
PRE-IND NON-CLINICAL
TRIALS 300 - 550 patients in total SUBMISSION CIALISATION
Randomized,
double-blinded study
NON-CLINICAL DATA CLINICAL STUDIES SAFETY DATABASE COMMERCIALISATION
Current documentation to be Two clinical, randomized and double- Patients from these clinical studies, as Commercialisation strategy for USA –
complemented with more data, to be blinded studies to be conducted to well as patients from the European whether to launch ourselves or
approved by FDA: confirm and ensure efficacy and safety. study will be included in the safety together with a local partner – to be
• Toxicity studies – animal and database of 500 isoflurane patients. decided around 2022.
PPND*
• Human factors validation
24 |
* PPND: pre- and post-natal development.4. Development & commercialisation
Combination registration of AnaConDa & IsoConDa in USA
Key operational activities and collaborations
Director of clinical development for the US Collaboration with Harvard and HF consultant
recruited. company for Human Factors Engineering Program.
Intend to set up a company in the US for
Contract Research Organization for non-clinical
management of studies, registration and market
studies.
access.
Close cooperation with relevant consultants and Collaboration with academic centers in the US
US key opinion leaders. initiated for planning of clinical studies.
25 |4. Development & commercialisation
Timeline – registration activities in Europe and US
MAA Approval NDA Approval
2019 2020 2021 2022 2023 2024
• February 2019 • Jan 2020 • H2 2021
Paediatric study IsoConDa study Completion of
approved completion paediatric study
• December 2019 • Q2 2020 • H2 2021
Target inclusion of Paediatric study - Registration
last patient in first patient in approval of
IsoConDa study • Summer 2020 IsoConDa
around turn of the Submit MAA
year application in 16
countries in a first
round
• March 2019 • June 2020 • 2021 • 2022 • 2023 • 2024
Pre-IND meeting Completion of IND approval and Decide whether to NDA application NDA approval
with FDA Human Factors clinical studies launch the expected
• August 2019 validation study begin products in US
Pilot testing of • Q4 2020 ourselves or
non-clinical studies IND application together with a
initiated local partner
26 |4. Development & commercialisation
Development highlights RoW
From proven therapy to approved standard of care
Japan China India
• Approval of AnaConDa in Japan in Q4 • 10-year exclusive distribution • Exclusive distribution agreement with
2018 agreement with Kyuan Xinhai Medical, Hansraj Nayyar Medical
• First patient treated in Q2 2019 a subsidiary of partly state-owned • Sales will commence in the fall 2019
Shanghai Pharma, the second largest
• Investigating the possibility for • Registration process for AnaConDa will
life science company in China
registration of IsoConDa – Pre-IND commence in parallel
meeting during H1 2020 • Kyuan will immediately commence
fast-track registration of AnaConDa
• Estimated time to approval is under
two years, by latest 2021
EUR 300m 5-6m 2m
Estimated annual Estimated ventilation Estimated ventilation
market potential days annually days annually
27 |TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
2 AnaConDa & IsoConDa – a superior combination for ICU sedation
Large & clearly defined market opportunity for replacement of
3 standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in
5 commercialisation of medtech and pharmaceutical products
6 Financial highlights
A Appendix
28 |5. Board & Management with extensive experience
Experienced management with proven track record
Christer Ahlberg CEO Peter Sackey CMO
ᴏ CEO of Sedana Medical since 1 February, 2017 ᴏ Chief Medical Officer at Sedana Medical from Jan 2018
ᴏ Former CEO of Unimedic Group 2010–2016 ᴏ Previous positions as Senior Consultant & Associate Professor at the Dept. of
ᴏ Former CEO of Eisai AB 2005–2010 Intensive Care Medicine, Perioperative Medicine and Intensive Care, Karolinska
ᴏ Christer also has over 10 years of experience in sales, marketing and market University Hospital
access positions from AstraZeneca, Meda and Wyeth ᴏ Over 20 years of clinical experience as an anesthesiologist and ICU physician
ᴏ Shareholding: 230,000 shares (1.16%) 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 (5. Board & Management with extensive experience
Diversified Board with extensive sector knowledge
Thomas Eklund Chairman of the Board Sten Gibeck Board Member
ᴏ Chairman since 2014 ᴏ Board member since 2005
ᴏ Thomas holds several Chairman of the Board positions in various companies, ᴏ Former owner and CEO of Louis Gibeck AB during its journey from being a small
including Moberg Pharma distribution company to achieving a leading position in its field
ᴏ He has vast experience from leading positions within the healthcare industry, ᴏ Sten was also previously Chairman of Sedana Medical and the European
for example as CEO and Head of Europe at Investor Growth Capital industry association Eucomed, which represents the medical technology
ᴏ Shareholding: 416,616 shares (2.10%) industry in Europe
ᴏ Shareholding: 1,605,744 shares (8.09%)
Bengt Julander Board Member Mike Ryan Board Member
ᴏ Board member since 2011 ᴏ Board member since 2005
ᴏ Bengt has more than 30 years of experience from the Life Science industry ᴏ Mike was CEO of Sedana Medical 2011-2017
ᴏ Currently the CEO of Linc, a private investment company ᴏ CEO of TecScan Ireland Ltd since 1990, and previously CEO/major shareholder
ᴏ Shareholding: 2,116,901 shares (10.67%) 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
ᴏ Shareholding: 1,068,083 shares (5.38%)
Ola Magnusson Board Member Eva Walde Board Member
ᴏ Board member since 2005 ᴏ Board member since 2018
ᴏ Ola has been with Sedana Medical since the foundation in 2005 and served as ᴏ Recently VP Commercial Operations at Phadia / ThermoFisher Scientific.
CEO of the company until 2011 ᴏ Previously leading positions in product management and market and strategy
ᴏ Ola has 25 years of experience from the pharmaceutical business in Pharmacia management within i.e. Hoechst, Bristol Myers Squibb, Pfizer and
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 Shareholding: 3,200 shares (0.02%)
ᴏ Shareholding: 1,340,867 shares (6.76%)
30 |TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
2 AnaConDa & IsoConDa – a superior combination for ICU sedation
Large & clearly defined market opportunity for replacement of
3 standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in commercialisation
5 of medtech and pharmaceutical products
6 Financial highlights
A Appendix
31 |6. Financial highlights
Financial highlights
Q2 2019 Gross margin development
• Net sales of 17,4 MSEK vs. 14,8 MSEK in Q2 2018, 20% growth individual quarter
and 24% rolling 12 months. Gross Profit, 12 months rolling
• Gross margin of 13,4 MSEK or 77% vs. 11,3 MSEK or 78 % in Q2 2018. Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 Q2-2019
• EBITDA -2,3 MSEK or -13,4% vs. -1,0 MSEK or -6,9% in Q1 2018. 50 000 80%
• OPEX increased with 30% vs Q2 2018 due to build up of European organisation and 45 000
40 000 75%
preparation for IsoConDa launch which means continued sales and market
investments during Q2. 35 000 70%
30 000
• 40 employees in average in Q2 vs. 30 employees end of 2018 for the group in total.
KSEK
25 000 65%
• Cash flow from operations was -2,1 MSEK. 20 000
• Cash flow from investments was -13,4 of which -8,8 MSEK concern product 15 000 60%
development. 10 000 55%
• Total cash flow for the group in Q2 was -12,6 MSEK. 5 000
0 50%
Gross Profit Gross Margin%
All time high sales in 1HY 2019 EBITDA development
• Close to 40% growth in France 1HY 2019 and significant sales increase in the UK
and Nordics
EBITDA, 12 months rolling
Q3-2017 Q4-2017 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 Q2-2019
20000 25%
20%
15000
15%
10000
KSEK 10%
Post-approval
5000 5%
0%
0
-5%
-5000
-10%
-10000 -15%
EBITDA EBITDA %
32 |6. Financial highlights
Financial results Q2 2019 vs. Q2 2018
(MSEK)
P&L Q2 Balance Sheet 30 June Cash Flow Q2
2019 2018 2019 2018 2019 2018
Revenues ASSETS
Cash flow from operations bef.
Net sales 17,4 14,5 Intangible assets 72,7 38,3 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
Cash flow from operations after
Operating cost and expenses 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
33 |6. Financial highlights
Largest shareholders at the end of June 2019
Number of Share
shares (%)
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
1 400 000 7,13%
(Brohuvudet AB)
Ola Magnussion direct and indirect
1 340 867 6,83%
(Magiola AB)
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.
34 |TABLE OF CONTENTS
1 Sedation in ICUs represents a large unmet clinical need
2 AnaConDa & IsoConDa – a superior combination for ICU sedation
Large & clearly defined market opportunity for replacement of
3 standard of care
ON OFF
4 Development & commercialisation
Board & Management with extensive experience in commercialisation
5 of medtech and pharmaceutical products
6 Financial highlights
A Appendix
35 |A. Appendix
Patient case study: James Spiegel – October 2017
“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.
“I am not a doctor but I believe if this were available to me earlier, things
would not have been as serious”
Back in the gym four weeks later
Upon 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.
“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.”
36 |A. Appendix
Select Publications
General
1. 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.
Cardio
1. 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.
Pulmonary
1. 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.
Neuro
1. 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.
37 |A. Appendix
Sources
1. 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
38 |A. Appendix
Sources cont’d
13. 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
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