21
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

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

Embed Size (px)

Citation preview

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