ADOCIA * CORPORATE PRESENTATION

ADOCIA – CORPORATE PRESENTATION

Actionaria event – Palais des Congrès

Paris, France – November 21-22, 2014

Disclaimer

This document has been prepared by ADOCIA (the "Company") and is provided for information purposes only.

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This document contains information on the Company’s markets and competitive position, and more specifically, on the size of its markets. This information has been drawn from various sources or from the Company’s own estimates. Investors should not base their investment decision on this information.

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November 2014 Property of ADOCIA 2

ADOCIA - Management

Gérard Soula

President & CEO

November 2014

Olivier Soula Valérie Danaguezian

Deputy General Manager

R&D Director

Chief Financial Officer

Property of ADOCIA

Rémi Soula

Business Development

& Intellectual Property Director

3

ADOCIA in brief

• Founded end of 2005 by Gérard, Olivier and Rémi Soula

 Listed on Euronext Paris since February 2012

 Experienced management and collaborators, including 30 Ph.Ds

 Cash position of €12.6M at end of September 2014

•

Platform technologies

 BioChaperone

® platform: a major leap to improve protein performance (insulin, growth factors, mAbs …)

 DriveIn

® platform: nanotechnology for targeted drug delivery in oncology

 New technologies for mAb formulation

•

3 therapeutic areas

 Diabetes: Unique portfolio of 3 insulin products in clinical development

 Wound healing, Diabetic Foot Ulcer treatment: BioChaperone PDGF-BB

 Oncology: Drive In -Doxorubicin and Drive In -Docetaxel, for the treatment of solid tumors


ADOCIA

A unique excellence center for innovative insulin formulation

November 2014

ADOCIA is deeply rooted in more than 75 years of cumulated experience in insulin formulation:

 More than 40 patents on insulin products

 8 clinical trials with insulin products

 60 R&D staff dedicated to insulin projects

Property of ADOCIA

Author unknown

5

Insulin: more than 90 years of progress towards a more physiological treatment

November 2014

BC LISPRO

BC COMBO

HINSBET

Property of ADOCIA 6

ADOCIA: a solid and diversified portfolio of products


Evolution of the stock over 2014

IPO: €15.88

DFU

Patent

Start of

Phase IIa

UF Lispro

Phase II combo

Results

Phase IIa

UF Lispro

Results

Start of

Phase II dose response

UF Lispro

Lispro

300U

Project

Start of

Phase IIa

Hinsbet

ADR

Phase II dose response

UF Lispro

Results

Start of

Phase III

BC PDGF-BB

ADA posters

Increase of the share price (€5.97 on 1 st January - €30 on 29 th October),

associated with an increase of the shares average trading volume (6,200 in 2013 and > 50,000 in 2014)


Technology


BioChaperone

®

: A new concept based on molecular assembly

Insulin,

Growth factors, mAbs…

• BioChaperone’s uniqueness for proteins formulation:

 Enhance protein solubility in physiological conditions

 Stabilize proteins against aggregation

 Protect proteins against enzymatic degradation

•

Medical and economical advantages expected:

 Improved efficacy of existing treatments

 Improved observance (reduced administration frequency, new combinations…)

 Improved pharmaco-economics (higher efficacy/lower quantities of protein)

•

Technology patented until 2033


Products breakthrough

1.

Insulin therapy

2.

Wound healing

3.

Oncology


Diabetes: a significant and growing pandemic

95 M

Treated

206 M

Diagnosed

382 M

Diabetics

+55%

592 M

Diabetics

2013

November 2014 Property of ADOCIA

Adapted from International Diabetes Federation, Diabetes Atlas, 6 th Edition, 2013

2035

12

Insulin is the ultimate treatment for type 2 diabetes patients, and the only option for type 1 diabetes patients

Treatment intensification

$23 B

Insulin

25%

Treated diabetics use Insulin

Oral

Antidiabetics

GLP-1

Property of ADOCIA

Disease progression

13 November 2014

Two major types of insulin products

70

60

50

40

30

20

10

6:00

Prandial insulins

(Humalog ® , Novolog ® , Humulin®…)

7 B$

10:00 14:00 18:00 22:00

Basal insulins

(Lantus ® , Levemir ® , Tresiba ® )

2:00 6:00

10 B$

Breakfast Lunch Dinner


(1) Figures for 2013, based on data from Novo Nordisk, Full year 2013 presentation Feb 2014; Companies

Financial reports 4Q13 & Sanofi’s Annual Report 2013.

14

Our innovative portfolio meets the challenges raised by the new insulin landscape

Humalog



Oncea-week

HinsBet



BC Combo

Glargine/Fast


Insulin products: $22.9 billion (1) , CAGR 15.7% (2008-2013) (1)

 Human insulin market: $3.5 billion

 Insulin analogs market: $19.4 billion

Novo

Nordisk

Human Insulin

Novolin N & R

($2.0 B)

Fast acting

Analogs

NovoLog

®

($3,1 B)

2014 *

Eli Lilly

Humulin family

($1.3 B)

Humalog

®

($1,95 B)

2013 *

Sanofi Insuman ® ($0.2 B) Apidra

®

($0.4 B)

2017 *

* Year product is off-patent

Long acting Insulins Premixed Insulins

Insulin Combos

(long+fast-acting)

Levemir

®

($2,1B)

2018*

Tresiba ®

(Europe/Japan)

2024 *

Novomix

®

($1.8 B)

Ryzodeg ®

(Europe/Japan)

/

Humalogmix ®

($0,65 B)

/

Lantus

®

($7.8 B)

2015 *

/ /

Our challenge: bring innovation to existing products which will soon be off-patent


Sources: (1) Novo Nordisk, Full year 2013 presentation Feb 2014; All other figures: Companies Financial reports 4Q13, except Apidra and Insuman : Sanofi’s Annual Report

2013.Humalog/HumalogMix split by Adocia’s estimate

BioChaperone for Prandial Insulins


Medical need for ultra-fast insulins

Ultra-fast insulins

Injection adapted to the actual meal

Improved medical benefit

Less hyper-glycemic events

Less hypo-glycemic events


Patients needs will drive the development of a range of ultra-fast products

Children

ULTRA-FAST INSULIN

Pump users

40%

American T1D use pumps 1

Severely insulin- resistant

86%

Overweight

T2D 2

 Mealtime dosing for better accuracy

 Real-time dosing

 Smaller pumps for better QoL

“Standard” U100

 High performance

 Smaller injected volumes

 Less pain

November 2014

Sources: 1 Medtronic, 2010 ; 2 Daousi et al (2006) Postgrad Med J 2006;82:280-284.

“Concentrated” U200


New products in development to meet the trends

Humalog

U200 EU approved

Current insulin analogs

FIAsp

Phase 3

BC

Analo g

Phase

2

Towards faster action

Afrezza

US approved

Adocia develops a unique portfolio of “ultra-fast AND concentrated” insulins


Results of phase 2a trial on 36 Type 1 Diabetic patients

Pharmacokinetics « faster-in » and « faster-out »

ADOCIA Ultra-fast insulins

Ultra-fast BC Lispro U100

Mean Serum insulin level

69 min

These results were presented at conferences:


Double–blind study, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro (100 IU) vs. Humalog (100IU)

21

Phase 2a trial on 36 T1D patients

Pharmacodynamics

Mean Glucose Infusion Rate



These results were presented at conferences:


Double-blind, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro vs. Humalog 100 IU

22

Dose-exposure results for BC Lispro U100 (PK)

Second Phase IIa on 36 Type 1 diabetic patients



BC Lispro 0.4 U/kg

Normalized at 0.1 U/kg

November 2014

BC Lispro 0.2 U/kg

BC Lispro 0.1 U/kg Across a standard therapeutic dose range BioChaperone Lispro U100 :

 Confirms Ultra-fast absorption profile

 Shows dose-exposure proportionality

(R²>0.95)


Dose-response results for BC Lispro U100 (PD)

Second Phase IIa on 36 Type 1 diabetic patients



BC222 Lispro 0.4 U/kg



Across a standard therapeutic dose range, BioChaperone Lispro U100 shows:

 Ultra-fast metabolic effect

 Linear increase of early and total metabolic effects with dose (R²>0.98)


Clinical trials with BioChaperone Lispro

Conclusions



After being tested in 73 patients and 147 injections, BioChaperone Lispro:

 Is significantly faster than Humalog ®

 Presents a clinically robust performance across two different studies



Shows a proportional dose exposure across a therapeutically relevant dose range

 Is well tolerated in humans


BC Lispro U100

Next key steps for the clinical development



 Meal test study in type 1 diabetes using insulin pump to demonstrate medical benfit



Clinical trial planned in Q1 2015

 Simplified development plan, following Novo Nordisk’s FIAsp’s (ultra-fast

Novolog) plan



Preparation of meetings pre-IND (FDA) & Scientific Advice (EMA) to validate the development plan expected Q1 2015

 Phase III clinical trials could start Q1 2016


Innovation for everyone, everywhere

Prandial insulins

HinsBet ®

80% diabetics live in developing countries

November 2014

Source: International Diabetes Federation, Diabetes Atlas, 6 th Edition, 2013


Emerging markets: similar needs, different constraints

 Large populations to treat



Strong economic constraints

November 2014

Prandial insulins

HinsBet ®

…But same medical needs

 Better glycemic control

 Prevention of long term complications


Human insulin is the best-selling insulin in developing countries

Prandial insulins

HinsBet ®

58% of Novo’s insulin sales in China are human insulin



Large human insulin manufacturing capabilities in Asia

 RHI is more cost-effective than analogs

 RHI is 100% reimbursed in China

 BUT RHI action starts 15 min later than insulin analogs

HinsBet

®

: a human insulin as fast as an insulin analog


HinsBet, a fast-acting human insulin

Mean PD results (pig model)

Prandial insulins

HinsBet ®

HinsBet

NovoLog (aspart)

Actrapid (human insulin)

November 2014

Results for Phase 2a study are expected Q1 2015


BioChaperone for Glargine-based Combo


BioChaperone Combo

Many patients have difficulties with multi-daily insulin injections

Basal/Bolus Users

Semi-compliant patients

• Obese & poor self-image

• Not confident or not willing to handle injections

Poor compliance & self-management

Glargine market

$8bn

HbA1c


Glasgow RE. et al. Diabetes spectrum 2001 ; Skinner TC & Hampson SE Diabetes Care 2001; Gherman A et al. Pract Diab Int 2011

Premix Users

Patients in need of simplicity

• Elderly

• Issues with multiple injections

• Other issues: health literacy, cost…

Poor medical performance

Premix market

$2.4bn

32

BioChaperone for Combo:

Solubilizing Glargine for a real “2-in-1”


Improved Compliance

Patients’ needs

 Easy handling

 Simpler regimen

 Fewer injections

Improved HbA1c

Doctors’ requirements

 Fast prandial action

 Once-a-day basal

 Flexible dosage

Reconciling patients and physicians on treatment intensification


Phase 2a clinical trial in 20 Diabetics Type 1 (PD)

Basal action >24h, ultra-fast prandial action


Mean Glucose Infusion Rate

168 min

204 min p=0.01

BioChaperone Combo

HumalogMix 25

®

T onset

AUC

GIR 0-2h

AUC

GIR 12-30h

-37% (p=0.002)

+58% (p=0.001)

+57% (p=0.025)


Double –blind, randomized, cross-over study on 20 Type 1 Diabetics patients under euglycemic clamp; BC Combo (Glargine 300 IU/Lispro 100 IU) vs. HumalogMix 25

34

Phase 2a clinical trial in 20 Diabetics Type 1 (PD)

Basal action >24h


Mean blood glucose

Number of patients with duration ≥ 30h

17/19 for BC Combo vs. 6/20 for Premix (p=0.001)

BioChaperone Combo

HumalogMix 25

®


Double –blind, randomized, cross-over study on 20 Type 1 Diabetics patients under euglycemic clamp; BC Combo (Glargine 300 IU/Lispro 100 IU) vs. HumalogMix 25

35

BioChaperone Glargine Lispro Combo

BioChaperone Combo may present unique advantages over Novo Nordisk’s Ryzodeg ®

Ryzodeg

®

(Novo Nordisk) medical benefits in clinical trials:

 Improved fasted glucose control

 Faster achievement of HbA1c target

 Less insulin consumption

 Lower rate of hypoglycemia

ADOCIA’s BioChaperone Combo advantages over Ryzodeg ®

(Novo Nordisk)

 Insulin Glargine long safety and efficacy track-record (>15 years)

 Potential faster prandial action (based on the results of Phase I/II of the two products)

 Low cost of production

November 2014

Source: Novo Nordisk, based on trial NN5401-3592 and NN5401-3597



Next steps for BioChaperone Combo



Phase IIa dose-response clinical study starting Q1 2015

• 36 Type 1 Diabetic patients

• Dose-exposure relationship measurement



Simplified development plan relying on glargine/lispro existing results

 Preparation of meetings pre-IND (FDA) & scientific advice (EMA) to validate the development plan



Phase III program could start in Q1 2016


BioChaperone Insulin portfolio: ‘Best-in-class’ products

‘Gold-standard’

1 st Generation

 Established safety and efficacy

 Part of patients’ everyday life

November 2014

+

BioChaperone

 Simple

 Short clinical trial

 Safe and well tolerated

Property of ADOCIA

‘Best-in-class’

2 nd Generation

Efficacy

Medical benefit

38

Next developments milestones in BioChaperone insulins

HinsBet

BC Combo

Product

BioChaperone Lispro U100

BioChaperone Lispro U200

Event

Results

Phase IIa on type 1 diabetics

Launch

Dose-response Phase IIa on type 1 diabetics

Launch

Pump study, Phase IIa on type 1 diabetics

Start

Phase I/II on type 1 diabetics

Expected timeline

Q1 15

Q1 15

Q1 15

Q1 15


Product Breakthrough

1.

Insulin therapy

2.

Wound healing

3.

Oncology


Diabetic Foot Ulcer (DFU): a life-threatening disease

Chronic hyperglycemia

Neuropathy

& Ischemia

Diabetic Foot Ulcer

15% of diabetic patients will develop a

DFU

60 %

Neuroischemic patients in

Western countries

November 2014

1 Armstrong, D. G. et al Int Wound J 2007, 4 (4), 286-287


Wound healing potential market

+

Organogenesis

ADOCIA

Smith & Nephew,

DermaSciences

Urgo, Convatec, Mölnlycke,

Systagenix….

Cellular therapies~ $10,000,

Complex management

Biologics~ $1,500

Only approved product for

DFU: Regranex ® (PDGF-BB)

Dressings ~$200

-


Advantages of BioChaperone PDGF-BB vs Regranex ®

•

Easy to use and convenient

 Applied once every two days (vs. daily for Regranex

®

)

 Ready-to-use spray

 Sterile without preservatives

 Multi-uses for 6 weeks

 Stable up to 3 months at 30

°

C and 30 months at 5

°

C

•

Cost effective

 1/3 of PDGF dosage vs. Regranex

®

 Reduced cost of treatment due to reduced frequency of application

BioChaperone PDGF-BB spray meets the requirements for a first-line advanced wound care treatment


BC PDGF-BB is non-inferior to Regranex at a third the dosage, applied half as often

Once a day

Phase I/II study in 200 diabetic patients in India

Incidence of complete wound closure after 20 weeks

79%

38/48

66%

31/47

Once every 2 days

Weekly dose divided by 3


Registered in clinical trials.gov under the #NCT01098357; 192 patients (both neuroischemic and neuropathic). Phase II multicenter, open-label, controlled, randomized trial.

44

BioChaperone PDGF

Two products for two markets

Clinical proof of concept established in Phase I/II on DFU (India)

60-80%

Neuropathic

Emerging markets

WHO-GMP PDGF

Western markets cGMP PDGF

60%

Neuroischemic

 EMA-validated shortened clinical development plan

 Phase III launched Aug. 2014

(India)

Phase III results expected

Q1 16

Next steps

Pre-IND meeting planned Q2 15

European Phase III Q4 15


BioChaperone PDGF:

Phase III clinical study launched in India

 DCGI approval received August 22, 2014

 Phase III clinical study

• 252 DFU patients – 25 to 30 investigators centers

•

• Biochaperone PDGF-BB vs. placebo

 Goal of the study: Confirm product effectiveness

• Principal criteria: Complete wound healing after max 20 weeks of treatment

• Secondary criteria: Wound healing in 10 weeks & Recurrence rate (3 months after wound closure)

 Support marketing approval in India and other emerging countries

 Act as supportive data to a Phase III trial in Europe for EU registration


Adocia’s BC PDGF-BB is supported by an international

Medical Advisory Board

“The committee was enthusiastic about BC PDGF-BB and the results obtained during

Adocia’s first Indian trial and will support the development of BioChaperone PDGF ‐ BB in western as well as in emerging countries”.

Jan Apelqvist MD, PhD

Michaël Edmonds

MD

Jean-Charles Kerihuel

Sylvie Meaume MD, PhD

Stephan Morbach MD

MD

David Armstrong

DPM, PhD, MD Akita Sadanori

MD, PhD

Terry Treadwell

MD


Products breakthrough

1.

Insulin therapy

2.

Wound healing

3.

Oncology


ADOCIA in Oncology

Monoclonal Antibodies

Formulation

DriveIn

®



Improve mAb solubility

 Reduce viscosity in highly

 concentrated solution

Improve stability upon storage



Targeted delivery for chemotherapy

 Biomimetic hyaluronanbased Trojan horse

2 ongoing partnerships with major pharmaceutical companies


Phase 1 planned to start Q4 2015

49

Financial Statements


2014 half year results: brief statement of accounts

In € thousands (IFRS rules)

Revenue

Other income

Total income

Operating expenses

Profit/loss from operating activities

Net profit/loss after tax

30/06/2014

0,2

1,7

1,9

(7,4)

(5,6)

30/06/2013

0,9

1,8

2,7

(7,4)

(4,6)

Variation

-30%

-21%

(5,5) (4,6) -20%


Results end of September 2014 and balance sheet details

•

Turnover end of September: €0.2M (collaboration agreements on mAbs) versus €5.6M in 2013 (depreciation balance on the initial payment from Lilly)

•

Cash position end of September 2014:

€12.6M

•

Burn rate on the first three quarters in 2014:

€6.8M

(

€3.2M cash in June 2014 of the tax credit research on 2013 spending)

•

Long term debt: €1.8M loan from BPI France

(refundable only in case of commercial and/or technical success)


Shareholders as of September 30, 2014

Shareholders equity

•

Listed on Euronext Paris since February 2012

•

6.2 million shares, with a float nearly 44% (*)

•

Market capitalization (end of Oct 2014) = €190M

•

ADR Program with BNY since May 2014 (ADOCY)

•

Analysts:

 Kepler Market (Lionel Labourdette)

 Invest Securities (Daniel Anizon)

 Life Sci Advisors (Andrew I. Mc Donald)

(*) including, where appropriate, the shares held by existing investors of the company


ADOCIA – Next steps


ADOCIA – Next steps

Product / Technology

HinsBet

Biochaperone Combo

Biochaperone Lispro U100

Biochaperone Lispro U200 mAbs technologies

DriveIn

BC PDGF-BB

BC PDGF-BB

November 2014

Therapeutic area

Diabetes

Diabetes

Diabetes

Diabetes

Event

Expected timeline

Phase IIa study results

Phase IIa dose-response study launch

Phase II on type 1 diabetics , pump study, launch

Phase I/II study launch

Q1-2015

Q1-2015

Q1-2015

Q1-2015

Depending on partner Ongoing collaborative developments -

Q4-2015 Oncology

Diabetes

Phase I launch

Phase III – Europe study launch

Diabetes Phase III – India n study Results

Q4-2015

Q1-2016


Thank you for your kind interest

Persons depicted in this document are models that are intended to enhance the presentation. They are not affected by any disease or treatments mentioned in this present document.

Contact

115 avenue Lacassagne – 69003 Lyon

Tél + 33 4 72 610 610 www.adocia.com

SA au capital de 619.227,60 € - RCS Lyon 487 647 737 00021


ADOCIA * CORPORATE PRESENTATION

Diagnosed

+55%

Diabetics

2035

Insulin

Prandial insulins

Basal insulins

Humalog

U200 EU approved

Current insulin analogs

FIAsp

Phase 3

BC

Analo g

Phase

2

Towards faster action

Afrezza

US approved

HinsBet

: a human insulin as fast as an insulin analog

BioChaperone

ADOCIA

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