Confidential Medirio SA, Techno-Pôle 10, 3960 Sierre, Switzerland BREAKTHROUGH INNOVATION IN THE INSULIN PEN MARKET Company introduction December 2, 2014 E [email protected] M +41 79 820 20 86 Irio Calasso, PhD CEO
Jul 14, 2015
Confidential Medirio SA, Techno-Pôle 10, 3960 Sierre, Switzerland
BREAKTHROUGH INNOVATION IN THE INSULIN PEN MARKET
Company introduction December 2, 2014
E [email protected] M +41 79 820 20 86
Irio Calasso, PhD CEO
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
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
DIABETES REGULATES THE LIFE OF 382M PEOPLE
( TYPE 1 )
( TYPE 2 )
Medirio SA. December 2, 2014 Slide 4. Confidential
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
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
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
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.
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
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
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
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.
Medirio SA. December 2, 2014 Slide 13. Confidential
DIS
CUSS
ION
FO
R CO
-DEV
ELO
PMEN
T /
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 PO
SITI
VE O
UTC
OM
E N
EGAT
IVE
OU
TCO
ME
1Q / 2015
1Q / 2017
BASED ON EXIT OR OEM SUPPLIER TO INDUSTRIES IN DIABETES MARKET
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. )
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
( m
illio
ns )
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” )
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
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%
mio
CH
F
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
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
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
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
Confidential Medirio SA, Techno-Pôle 10, 3960 Sierre, Switzerland
or visit us at www.medirio.com
Irio Calasso, PhD CEO E [email protected] M +41 79 820 20 86
OUR MARKET IS THE INSULIN PEN MARKET