adocia – corporate presentation actionaria event – palais des congrès paris, france –...

ADOCIA – CORPORATE PRESENTATION

Actionaria event – Palais des Congrès

Paris, France – November 21-22, 2014

Property of ADOCIA 2

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

The information and opinions contained in this document are provided as of the date of this document only and may be updated, supplemented, revised, verified or amended, and thus such information may be subject to significant changes. The Company is not under any obligation to update the information or opinions contained herein which are subject to change without prior notice.

The information contained in this document has not been subject to independent verification. No representation, warranty or undertaking, express or implied, is made as to the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiaries, its advisors and representatives accept no responsibility for and shall not be held liable for any loss or damage that may arise from the use of this document or the information or opinions contained herein.

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.

This document contains certain forward-looking statements. These statements are not guarantees of the Company's future performance. These forward-looking statements relate to the Company's future prospects, developments and marketing strategy and are based on analyses of earnings forecasts and estimates of amounts not yet determinable. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. Forward-looking statements cannot, under any circumstance, be construed as a guarantee of the Company's future performance and the Company’s actual financial position, results and cash flow, as well as the trends in the sector in which the Company operates, may differ materially from those proposed or reflected in the forward-looking statements contained in this document. Even if the Company’s financial position, results, cash-flows and developments in the sector in which the Company operates were to conform to the forward-looking statements contained in this document, such results or developments cannot be construed as a reliable indication of the Company's future results or developments. The Company does not undertake any obligation to update or to confirm projections or estimates made by analysts or to make public any correction to any prospective information in order to reflect an event or circumstance that may occur after the date of this document.

This document does not constitute an offer to sell or subscribe or a solicitation to purchase or subscribe for securities in France, the United States or any other jurisdiction. Securities may not be offered or sold in the United States absent registration under the US Securities Act of 1933, as amended, or an exemption from registration thereunder. No public offering of securities will be conducted in France or abroad prior to the delivery by the French Autorité des Marchés Financiers (Financial Markets Authority) of a visa on a prospectus that complies with the provisions of Directive 2003/71/CE as amended. No public offering of securities is contemplated in France or any jurisdiction outside France.

The distribution of this document may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions.

Disclaimer

November 2014


ADOCIA - Management

Gérard Soula Olivier Soula Valérie Danaguezian Rémi Soula

President & CEO Deputy General Manager Chief Financial Officer Business Development R&D Director & Intellectual Property Director

November 2014


• 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: DriveIn-Doxorubicin and DriveIn-Docetaxel, for the treatment of solid tumors

ADOCIA in brief

November 2014

Property of ADOCIA 5November 2014

ADOCIAA unique excellence center for innovative insulin formulation

Author unknown

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

6

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

November 2014 Property of ADOCIA

BC LISPRO

BC COMBO

HINSBET


ADOCIA: a solid and diversified portfolio of products

November 2014


Evolution of the stock over 2014

Increase of the share price (€5.97 on 1st January - €30 on 29th October),associated with an increase of the shares average trading volume (6,200 in 2013 and > 50,000 in 2014)

ADR

Phase IIaUF LisproResults

Lispro 300U

Project

IPO: €15.88

ADAposters

Start ofPhase IIa UF Lispro

Phase II comboResults

Start of Phase IIaHinsbet

Start of Phase III

BC PDGF-BB

Start of Phase II

dose response UF Lispro

DFUPatent

Phase II dose response

UF Lispro Results


Technology

November 2014


• 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

BioChaperone®: A new concept based on molecular assembly

November 2014

Insulin,Growth factors,

mAbs…


1. Insulin therapy

2. Wound healing

3. Oncology

Products breakthrough

November 2014


Diabetes: a significant and growing pandemic

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

206 MDiagnosed

382 MDiabetics

2035

+55%

592 MDiabetics

2013

95 MTreated

November 2014


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

Oral Antidiabetics

GLP-1

Insulin25% Treated

diabetics use Insulin

Disease progression

$23 B

Treatment intensification

November 2014

Two major types of insulin products

70

60

50

40

30

20

10

Insu

lin (µ

U/m

L)

6:00 10:00 14:00 18:00 22:00 2:00 6:00

Breakfast Lunch Dinner

Basal insulins(Lantus®, Levemir®, Tresiba®)

Prandial insulins(Humalog®, Novolog®, Humulin®…)

(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.

November 2014 Property of ADOCIA 14

7 B$

10 B$

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

Novolin

Levemir

Tresiba

Novolog

Novomix

Ryzodeg

Once-a-week

UltrafastFA ins aspart

GlargineLispro

Insugen

AspartGlargine

GlargineGlargine

Gansulin

Aspart

Wosulin

Glargine

HinsBet

BC Combo Glargine/Fast

Humalog

Humulin

Lispro

U200 Glargine

Humalog Mix

PEG Lispro

U200

Ultrafast

BC Lispro

U100

Lantus

Insuman

AspartLispro

Apidra

Afrezza

Glargine 300


Human insulin market: $3.5 billion

Insulin analogs market: $19.4 billion

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

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

Human Insulin Fast acting Analogs

Long acting Insulins Premixed Insulins Insulin Combos (long+fast-acting)

Novo Nordisk

Novolin N & R($2.0 B)

NovoLog® ($3,1 B)

2014*

Levemir® ($2,1B)2018*

Tresiba®

(Europe/Japan) 2024*

Novomix® ($1.8 B) Ryzodeg®

(Europe/Japan)

Eli Lilly Humulin family($1.3 B)

Humalog® ($1,95 B)

2013*

/ Humalogmix®

($0,65 B)/

Sanofi Insuman® ($0.2 B)Apidra® ($0.4 B)

2017*

Lantus® ($7.8 B)2015* / /

* Year product is 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

November 2014

Medical need for ultra-fast insulins


Improved medical benefit

Injection adapted to the actual meal

Ultra-fast insulins

Less hyper-glycemic eventsLess hypo-glycemic events


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

Children Pump users Severely insulin- resistant

40% American T1D

use pumps1

86% Overweight

T2D2

Mealtime dosing for better accuracy

Real-time dosing Smaller pumps for better QoL

High performance Smaller injected

volumes Less pain

ULTRA-FAST INSULIN

“Standard” U100

“Concentrated” U200

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


New products in development to meet the trends

Tow

ard

s h

igh

er

con

cen

trati

on

Towards faster action

Humalog U200

EU approve

dCurrent insulin analog

s

FIAspPhase

3

Afrezza US

approved

BC Analog

Phase 2

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

Results of phase 2a trial on 36 Type 1 Diabetic patientsPharmacokinetics « faster-in » and « faster-out »

Mean Serum insulin level

ADOCIA Ultra-fast insulinsUltra-fast BC Lispro U100

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


69 min

These results were presented at conferences:

Phase 2a trial on 36 T1D patientsPharmacodynamics

Mean Glucose Infusion Rate

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



These results were presented at conferences:


Dose-exposure results for BC Lispro U100 (PK)Second Phase IIa on 36 Type 1 diabetic patients

Across a standard therapeutic dose range BioChaperone Lispro U100 : Confirms Ultra-fast absorption profile Shows dose-exposure proportionality

(R²>0.95)

BC Lispro 0.4 U/kg

BC Lispro 0.2 U/kg

BC Lispro 0.1 U/kg

Normalized at 0.1 U/kg


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)



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

Clinical trials with BioChaperone LisproConclusions

November 2014



BC Lispro U100Next 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

November 2014



Innovation for everyone, everywhere

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

80% diabetics

live in developing countries

November 2014

Prandial insulinsHinsBet®


Emerging markets: similar needs, different constraints

Large populations to treat

Strong economic constraints

…But same medical needs

Better glycemic control

Prevention of long term complications

November 2014


Human insulin is the best-selling insulin in developing countries

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

HinsBet

NovoLog (aspart)

Actrapid (human insulin)

Results for Phase 2a study are expected Q1 2015

Mean PD results (pig model)

November 2014



BioChaperone for Glargine-based Combo

November 2014

32

Many patients have difficulties with multi-daily insulin injections

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

Poor medical performancePoor compliance & self-management

HbA1c

• Obese & poor self-image• Not confident or not willing to handle

injections

Semi-compliant patients

• Elderly • Issues with multiple injections• Other issues: health literacy, cost…

Patients in need of simplicity

Basal/Bolus Users

Premix Users


Premix market$2.4bn

Glargine market

$8bn

BioChaperone Combo

33November 2014 Property of ADOCIA

BioChaperone for Combo: Solubilizing Glargine for a real “2-in-1”

Doctors’ requirements

Fast prandial action

Once-a-day basal

Flexible dosage

Patients’ needsEasy handling

Simpler regimen

Fewer injections

Improved Compliance Improved HbA1c

Reconciling patients and physicians on treatment intensification

BioChaperone Combo

34

Phase 2a clinical trial in 20 Diabetics Type 1 (PD)Basal action >24h, ultra-fast prandial action

Mean Glucose Infusion Rate

Tonset -37% (p=0.002)

AUC GIR 0-2h +58% (p=0.001)

AUC GIR 12-30h +57% (p=0.025)

BioChaperone Combo

HumalogMix 25®

204 min

168 min p=0.01

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


BioChaperone Combo

Phase 2a clinical trial in 20 Diabetics Type 1 (PD)Basal action >24h

Mean blood glucoseBioChaperone Combo

HumalogMix 25®

Number of patients with duration ≥ 30h

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


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

BioChaperone Combo

36

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

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


Ryzodeg® (Novo Nordisk) medical benefits in clinical trials:

Improved fasted glucose control

Faster achievement of HbA1c target

Less insulin consumption

Lower rate of hypoglycemia

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

BioChaperone Combo

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 Combo

Simple

Short clinical trial

Safe and well tolerated

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

‘Gold-standard’ 1st Generation

‘Best-in-class’2nd Generation

Efficacy

Medical benefit

+ BioChaperone

Established safety and efficacy

Part of patients’ everyday life

InsulinBC-Insulin


Next developments milestones in BioChaperone insulins

Product Event Expected timeline

HinsBetResults

Phase IIa on type 1 diabetics Q1 15

BC ComboLaunch

Dose-response Phase IIa on type 1 diabetics

Q1 15

BioChaperone Lispro U100Launch

Pump study, Phase IIa on type 1 diabetics

Q1 15

BioChaperone Lispro U200Start

Phase I/II on type 1 diabetics Q1 15



1. Insulin therapy

2. Wound healing

3. Oncology

Product Breakthrough

November 2014


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

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

Chronic hyperglycemia

Neuropathy & Ischemia

Diabetic Foot Ulcer15% of

diabetic patients will develop a

DFU

60 % Neuroischemic

patients in Western countries

November 2014


Wound healing potential market

Organo-genesis

ADOCIASmith & Nephew,

DermaSciences

Urgo, Convatec, Mölnlycke, Systagenix….

-

+

Seve

rity

of d

isea

se

Cellular therapies~ $10,000, Complex management

Biologics~ $1,500Only approved product for DFU: Regranex® (PDGF-BB)

Dressings ~$200

November 2014


Advantages of BioChaperone PDGF-BB vs Regranex®

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

• 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

November 2014

November 2014

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

Registered in clinical trials.gov under the #NCT01098357; 192 patients (both neuroischemic and neuropathic). Phase II multicenter, open-label, controlled, randomized trial. Property of ADOCIA 44

Once a day

Once every 2 days

Weekly dose divided by 3

66%

31/47

79%

38/48

Phase I/II study in 200 diabetic patients in India

Incidence of complete wound closure after 20 weeks


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

BioChaperone PDGFTwo products for two markets

Phase III launched Aug. 2014 (India)

WHO-GMP PDGFEmerging markets

cGMP PDGFWestern markets

Next steps

EMA-validated shortened clinical development plan

Phase III results expected Q1 16

Pre-IND meeting planned Q2 15

European Phase III Q4 15

60-80% Neuropathic

60% Neuroischemic

November 2014


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

November 2014


“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”.

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

Jan Apelqvist MD, PhD

David ArmstrongDPM, PhD, MD

Terry TreadwellMD

Michaël EdmondsMD

Akita Sadanori MD, PhD

Jean-Charles Kerihuel MD

Sylvie Meaume MD, PhD

Stephan Morbach MD


1. Insulin therapy

2. Wound healing

3. Oncology

Products breakthrough

November 2014

ADOCIA in Oncology

Monoclonal Antibodies Formulation

Improve mAb solubility

Reduce viscosity in highly concentrated solution

Improve stability upon storage

2 ongoing partnerships with major pharmaceutical companies

DriveIn®

Targeted delivery for chemotherapy

Biomimetic hyaluronan-based Trojan horse

Phase 1 planned to start Q4 2015



Financial Statements

November 2014


2014 half year results: brief statement of accounts

In € thousands (IFRS rules) 30/06/2014 30/06/2013 Variation

Revenue 0,2 0,9

Other income 1,7 1,8

Total income 1,9 2,7 -30%

Operating expenses (7,4) (7,4)

Profit/loss from operating activities

(5,6) (4,6) -21%

Net profit/loss after tax (5,5) (4,6) -20%

November 2014


• 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)

Results end of September 2014 and balance sheet details

November 2014


• 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)

Shareholders as of September 30, 2014

Shareholders equity

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

November 2014


ADOCIA – Next steps

November 2014


ADOCIA – Next steps

Product / Technology Therapeutic area EventExpected timeline

HinsBet Diabetes Phase IIa study results Q1-2015

Biochaperone Combo Diabetes Phase IIa dose-response study launch Q1-2015

Biochaperone Lispro U100 Diabetes Phase II on type 1 diabetics , pump study, launch Q1-2015

Biochaperone Lispro U200 Diabetes Phase I/II study launch Q1-2015

mAbs technologies Depending on partner Ongoing collaborative developments -

DriveIn Oncology Phase I launch Q4-2015

BC PDGF-BB Diabetes Phase III – Europe study launch Q4-2015

BC PDGF-BB Diabetes Phase III – India n study Results Q1-2016

November 2014

Property of ADOCIA

Contact

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

Tél + 33 4 72 610 610115 avenue Lacassagne – 69003 Lyon

www.adocia.com

56

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.

November 2014

adocia – corporate presentation actionaria event – palais des congrès paris, france –...

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