Ldb 145 Geni Mutanti_2014-11-26 Calasso - medirio sa company introduction

1. ConfidentialMedirio SA, Techno-Pôle 10, 3960 Sierre, Switzerland
BREAKTHROUGH INNOVATION IN THE INSULIN PEN MARKET
Company introduction
December 2, 2014
E calasso@medirio.com M +41 79 820 20 86
Irio Calasso, PhD CEO

2. NUMBER OF PEOPLE WITH DIABETES BY IDF REGION 2013
In the world there are approx. 382 Million patients living with diabetes and more than a half has
already been diagnosed. About 25% of the diagnosed people (type 1 and 2 together) require regular
insulin injections to survive.
Medirio SA. December 2, 2014 Slide 2. Confidential

3. STORYLINE
Diabetes treatment calls for gadgets that significantly increase the patients’ life complexity.
Patients are in continuous search of simplification.
Although a significant progress towards therapy simplification has been possible thanks to insulin
pumps, doctors keep prescribing insulin pens to the majority of patients (95%) as pump therapy
regime is complex and extensive technical skills are required. In addition, pen therapy costs less
than half the price of pump therapy to the Health Care system, thus leaving a small margin for
new instruments to compete with insulin pens. It is for the abovementioned reasons that no
substantial innovation exists in the pen market and each injection (3 to 5 times a day) remains
troublesome .
Medirio’s solution is a unique system for the pen market that addresses patients’ need for
simplification and discreetness without adding burdens to the budget of the Health Care system.
Medirio SA. December 2, 2014 Slide 3. Confidential

4. DIABETES REGULATES THE LIFE OF 382M PEOPLE
( TYPE 1 )
( TYPE 2 )
Medirio SA. December 2, 2014 Slide 4. Confidential

5. 95% OF PEOPLE ON INSULIN USE SYRINGES AND PENS
PROS OF PENS
• Cost efficient therapy compared to pumps
• Misuse is limited
CONS OF PENS
• Several handling steps before and after injection
• No discreetness
• Injections are burdensome
5%
DOCTORS PRESCRIBE PUMPS TO ONLY 5% OF PEOPLE ON INSULIN
Medirio SA. December 2, 2014 Slide 5. Confidential

6. Medirio SA. December 2, 2014 Slide 6. Confidential
INSULIN DELIVERY SYSTEMS
Therapy cost
1500 Euro/year
(95% of the market)
Reimbursed in most countries
3500 Euro/year
(5% of the market)
Reimbursed mainly for type 1
Complex therapy,
risk of misuse,
higher cost
Troublesome
therapy

7. Medirio SA. December 2, 2014 Slide 7. Confidential
A. Disposable Patch
B. Handheld device as user interface and
controller / drive unit
OUR SOLUTION FOR THE PEN MARKET
By placing the handheld device over the patch, the patch
unlocks and receives energy to pump insulin even through the
clothing.
Aesthetic prototype

8. Medirio SA. December 2, 2014 Slide 8. Confidential
INSULIN DELIVERY
A. The dose is selected on the handheld.
B. To inject, the handheld is placed over the
patch (over the clothes) for 5 to 15 seconds.
USABILITY
To inject insulin, patients simply place the handheld over the patch.
PREPARATION The disposable patch is attached to the
body for 3 to 4 days.

9. Medirio SA. December 2, 2014
IN THE DISPOSABLE PATCH
• No battery
• No electronics
• No motors
Low COG ( similar to insulin disposable pens )
Small and easy to wear.
IN THE HANDHELD
• User interface
• Driver and controller for the patch
• Reminders and log-file
• Connectivity
ENERGY TRANSFER FROM HANDHELD TO PATCH
THE BRILLIANCE OF OUR TECHNOLOGY
Slide 9. Confidential
Handheld, size and technology allows flexibility to
incorporate additional features

10. Medirio SA. December 2, 2014 Slide 10. Confidential
COMPETITORS LANDSCAPE
GREAT INJECTION EXPERIENCE AND ENHANCED USABILITY AT PEN COSTS
Therapy cost
1500 Euro/year
(95% of the market)
Reimbursed in most countries
3500 Euro/year
(5% of the market)
Reimbursed mainly for type 1
OUR SYSTEM
z

11. Medirio SA. December 2, 2014 Slide 11. Confidential
1Q/2015 4Q/2015
PROOF OF CONCEPT Fully functional
patch
Fully functional
system prototype
(inj. molded)
6 Patent families filed
( 1 in preparation )
Closing financial round A
Team completion
CTI project grant (350 kCHF )
No clinical studies
required for CE Label
Manufacturing costs of
goods estimated
Alliance/Partnership with SOLTECH APS
( R&D engineering)
ACHIEVEMENTS AND NEXT STEPS
1Q/2014
today
CTI project
Patch
SOLTECH APS
Hand-Held
(Outsourced)
Project at
Brunel (London)
Hand-held prototype
available

12. Medirio SA. December 2, 2014 Slide 12. Confidential
INTELLECTUAL PROPERTIES
No prior art documents have been so far identified (as indicated by own carried out searches and
analysis of competitors’ portfolios and also by the search reports of our own applications), which
are of particular concern for patentability or for freedom to operate.
PUBLISHED
EP2379132
Safety mechanism.
EP2617445
Interaction between the hand-held and the patch.
EP2674177
Patch assembly to extend the shelf life.
DM/082696
(International Design)
EP13154302.7
(Sensors)
NOT PUBLISHED
EP14156056.5 (priority 20.02.2014)
Safety.

13. Medirio SA. December 2, 2014 Slide 13. Confidential
DISCUSSIONFORCO-DEVELOPMENT/EXIT
BUSINESS STRATEGY OPTIONS
Continue development to CE
label
FULLY
FUNCTIONAL
PATCH
PROTOTYPE
OEM to Insulin company
OEM to MedTech company
3rd EXIT
OPTION
1st EXIT
OPTION
With Insulin company
BGM with MedTech company
Co-development of
the final product
2nd EXIT
OPTION
POSITIVEOUTCOMENEGATIVEOUTCOME
1Q / 2015
1Q / 2017
BASED ON EXIT OR OEM SUPPLIER TO INDUSTRIES IN DIABETES MARKET

14. Medirio SA. December 2, 2014 Slide 14. Confidential
PARTNERSHIP AND EXIT COMPANIES
• INSULIN PHARMACEUTICAL COMPANY
( Novo Nordisk, Eli-Lilly, Sanofi-Aventis, Berlin-Chemie, Jilin Tonghua Dongbao, Jiangsu Wanbang
Biopharmaceuticals, Bioton, Bicon, or new comers with generic insulin )
• PLAYER IN DIABETES MEDTECH
( Medtronic, J&J, Abbott, Bayer, Roche, BD-Medical, Menarini, etc. )

15. Medirio SA. December 2, 2014 Slide 15. Confidential
MARKET (Type 1 & Type 2)
INSTRUMENTS USED TO INJECT INSULIN
3.3
1
4.7 9.5
0.9
2
0
2
4
6
8
10
12
14
2008 2015
Users(millions)
Syringe users Pen users Pump users
OUR TARGET
MARKET
Market potential (in W-UE and USA only). 850 million disposable units/year
( Type 1 and Type 2 diabetes on insulin multiple daily injections “MDI” )

16. Medirio SA. December 2, 2014 Slide 16. Confidential
ASSUMPTIONS:
• Market potential with no growth: 900 mio. disposables per year (W-EU and USA only).
• Conservative market penetration (lower than by Insulet with the OmniPod introduction in the U.S. market)
Year 2017 2018 2019 2020
Market penetration % (assumption) 0.05 0.5 1.50 3.50
Sales (mio CHF) 0.5 4.9 14 31
EBIT (mio CHF) -1.9 1.3 9.6 25.5
REVENUES PROJECTION
OEM REPETITIVE SALE OF DISPOSABLE

17. Medirio SA. December 2, 2014 Slide 17. Confidential
CUMULATIVE FIGURES (FIRST 4 YEARS)
ASSUMPTIONS
• Market potential with no growth (W-UE and USA only);
• COGs and selling price decrease in fixed proportion with the increase of manufacturing quantity
0
100
200
300
400
500
600
700
800
2% 4% 7% 11%
mioCHF
Market penetration
Revenues from disposable
EBIT
*
* Shown in 4 years by Insulet
Corp. with the OmniPod the first
insulin patch pump.
self-introduced in the US market.
FOR DIFFERENT MARKET PENETRATIONS REACHED IN THE 4th YEAR

18. Medirio SA. December 2, 2014 Slide 18. Confidential
ROADMAP TO CE LABEL
XY MIO XY MIO XY MIO
1Q/2014 1Q/2015 4Q/2015 2Q/2016
READY
1Q/2017
Fully functional
patch
Fully functional
system prototype
(inj. molded)
Development
for
manufacturing
Transfer to
mass
manufacturing
INVESTORS PARTNERSHIP WITH A COMPANY IN DIABETES
INVESTORS
A
B
CAPITAL NEED
PRODUCT DEVELOPMENT

19. Medirio SA. December 2, 2014 Slide 19. Confidential
MEDIRIO SA
General Management: IRIO CALASSO, > 10 years in diabetes (Roche, etc) as
project leader, head of product development.
3 years CEO of Xellex AG (Pharma)
Expert of diabetes market. PhD in Physics ETHZ
Advisor & Shareholder: GIANPIERO REVERBERI , 10 years at Eli Lilly. Head of the
Diabetes Care Business Unit (Italy), manager in business
development (USA). 10 years at Shire most as Senior Vice
President International Specialty Pharma.
Development: MATTEO DE DONATIS, > 6 years in Ergonomics and product
development as project leader and manufacturing
consultant. Product Des. Eng. (Politecnico di Milano)
SOLTECH APS (Maaloev, DK), QS ISO 13485
Partner in product development
Patents: Internal / Outsourced
Regulatory: Outsourced
FOCUSED AND LEAN ORGANIZATION

20. Medirio SA. December 2, 2014 Slide 20. Confidential
ALLIANCE WITH SOLTECH ApS (Maaloev, Denmark)
• Consolidated development know-how and resources
• Secured access to all the necessary equipment and
relevant instruments for engineering, manufacturing
and testing
Established strategic alliance and partnership for the development

21. ConfidentialMedirio SA, Techno-Pôle 10, 3960 Sierre, Switzerland
or visit us at www.medirio.com
Irio Calasso, PhD CEO E calasso@medirio.com M +41 79 820 20 86
OUR MARKET IS THE INSULIN PEN MARKET