ADOCIA * CORPORATE PRESENTATION

Report
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.
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.
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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
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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.
November 2014
Property of ADOCIA
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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: DriveIn-Doxorubicin and DriveIn-Docetaxel, for the treatment of solid tumors
November 2014
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ADOCIA
A unique excellence center for innovative insulin formulation
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
Author unknown
November 2014
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Insulin: more than 90 years of progress towards a more
physiological treatment
BC LISPRO
BC COMBO
HINSBET
November 2014
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ADOCIA: a solid and diversified portfolio of products
November 2014
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Evolution of the stock over 2014
Lispro
300U
Project
Phase IIa
UF Lispro
Results
DFU
Patent
Phase II
combo
Results
IPO: €15.88
Start of
Phase IIa
Start of
Phase II
dose response
UF Lispro
Start of
Phase IIa
Hinsbet
Phase II
dose response
UF Lispro
Results
Start of
Phase III
BC PDGF-BB
ADR
UF Lispro
ADA
posters
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)
November 2014
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Technology
November 2014
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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
November 2014
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Products breakthrough
1.
Insulin therapy
2.
Wound healing
3.
Oncology
November 2014
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Diabetes: a significant and growing pandemic
592 M
382 M
Diabetics
206 M
95 M
Treated
Diagnosed
+55%
2035
2013
November 2014
Adapted from International Diabetes Federation, Diabetes Atlas,
Diabetics
Property of ADOCIA
6 th
Edition, 2013
12
Insulin is the ultimate treatment for type 2 diabetes patients,
and the only option for type 1 diabetes patients
Treatment
intensification
$23 B
Insulin
Oral
Antidiabetics
GLP-1
25%
Treated
diabetics
use Insulin
Disease
progression
November 2014
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Two major types of insulin products
Prandial insulins
(Humalog®,
Novolog®,
Humulin®…)
7 B$
Insulin (µU/mL)
70
60
50
Basal insulins
40
(Lantus®, Levemir®, Tresiba®)
30
10 B$
20
10
6:00
10:00
Breakfast
November 2014
14:00
Lunch
18:00
22:00
2:00
6:00
Dinner
Property of ADOCIA
(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.
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Our innovative portfolio meets the challenges raised by the new
insulin landscape
Humalog
BC Combo
Glargine/Fast
Oncea-week
HinsBet
November 2014
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Insulin products: $22.9 billion(1), CAGR 15.7% (2008-2013)(1)

Human insulin market: $3.5 billion

Insulin analogs market: $19.4 billion
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
Our challenge: bring innovation to existing products which will soon be off-patent
November 2014
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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
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Medical need for ultra-fast insulins
Ultra-fast insulins
Improved medical benefit
Injection adapted
to the actual meal
November 2014
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Less hyper-glycemic events
Less hypo-glycemic events
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Patients needs will drive the development of a range of ultra-fast products
ULTRA-FAST INSULIN
Children
 Mealtime dosing for
better accuracy
Severely insulin- resistant
Pump users
40%
86%
American T1D
use pumps1
Overweight
T2D2
 Real-time dosing
 Smaller pumps for better QoL
 High performance
 Smaller injected
volumes
 Less pain
“Standard” U100
“Concentrated” U200
November 2014
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Sources: 1Medtronic, 2010 ; 2Daousi et al (2006) Postgrad Med J 2006;82:280-284.
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Towards higher concentration
New products in development to meet the trends
Humalog U200
EU approved
Current
insulin analogs
BC Analog
Phase 2
FIAsp
Phase 3
Afrezza
US approved
Towards faster action
Adocia develops a unique portfolio of “ultra-fast AND concentrated” insulins
November 2014
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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:
November 2014
Property of ADOCIA
Double–blind study, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro (100 IU) vs. Humalog (100IU)
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Phase 2a trial on 36 T1D patients
Pharmacodynamics
ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100
Mean Glucose Infusion Rate
These results were presented at conferences:
November 2014
Property of ADOCIA
Double-blind, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro vs. Humalog 100 IU
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Dose-exposure results for BC Lispro U100 (PK)
Second Phase IIa on 36 Type 1 diabetic patients
ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100
Normalized
at 0.1 U/kg
BC Lispro 0.4 U/kg
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)
November 2014
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Dose-response results for BC Lispro U100 (PD)
Second Phase IIa on 36 Type 1 diabetic patients
ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100
BC222 Lispro 0.4 U/kg
BC222 Lispro 0.2 U/kg
BC222 Lispro 0.1 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)
November 2014
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Clinical trials with BioChaperone Lispro
Conclusions
ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100
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
November 2014
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BC Lispro U100
Next key steps for the clinical development
ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100
 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
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Prandial insulins
HinsBet®
Innovation for everyone, everywhere
80%
diabetics
live in developing
countries
November 2014
Source: International Diabetes Federation, Diabetes Atlas,
Property of ADOCIA
6 th
Edition, 2013
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Prandial insulins
HinsBet®
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
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Human insulin is the best-selling insulin in
developing countries
Prandial insulins
HinsBet®
 Large human insulin manufacturing capabilities in Asia
58%
of Novo’s
insulin sales
in China are
human insulin
 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
November 2014
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Prandial insulins
HinsBet®
HinsBet, a fast-acting human insulin
Mean PD results (pig model)
HinsBet
NovoLog (aspart)
Actrapid (human insulin)
Results for Phase 2a study are expected Q1 2015
November 2014
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BioChaperone for Glargine-based Combo
November 2014
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BioChaperone Combo
Many patients have difficulties with multi-daily insulin injections
Premix Users
Basal/Bolus Users
Patients in need
of simplicity
Semi-compliant
patients
• Obese & poor self-image
• Not confident or not willing to handle
injections
• Elderly
• Issues with multiple injections
• Other issues: health literacy, cost…
Poor compliance & self-management
Glargine
market
Poor medical performance
HbA1c
$8bn
November 2014
Premix
market
$2.4bn
Property of ADOCIA
Glasgow RE. et al. Diabetes spectrum 2001 ; Skinner TC & Hampson SE Diabetes Care 2001; Gherman A et al. Pract Diab Int 2011
32
BioChaperone for Combo:
Solubilizing Glargine for a real “2-in-1”
BioChaperone Combo
Improved Compliance
Improved HbA1c
Patients’ needs
Doctors’ requirements
Easy handling
 Fast prandial action
Simpler regimen
 Once-a-day basal
Fewer injections
 Flexible dosage
Reconciling patients and physicians on treatment intensification
November 2014
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BioChaperone Combo
Phase 2a clinical trial in 20 Diabetics Type 1 (PD)
Basal action >24h, ultra-fast prandial action
Mean Glucose Infusion Rate
168 min
BioChaperone Combo
p=0.01
HumalogMix 25®
204 min
November 2014
Tonset
-37% (p=0.002)
AUC GIR 0-2h
+58% (p=0.001)
AUC GIR 12-30h
+57% (p=0.025)
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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
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Phase 2a clinical trial in 20 Diabetics Type 1 (PD)
Basal action >24h
BioChaperone Combo
Mean blood glucose
BioChaperone Combo
HumalogMix 25®
Number of patients
with duration ≥ 30h
November 2014
17/19 for BC Combo
vs. 6/20 for Premix (p=0.001)
Property of ADOCIA
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
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BioChaperone Combo
BioChaperone Glargine Lispro 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
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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
November 2014
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BioChaperone Insulin portfolio: ‘Best-in-class’ products
‘Gold-standard’
1st Generation
‘Best-in-class’
2nd Generation
+ BioChaperone
 Simple
 Short clinical trial
 Established safety
and efficacy
 Safe and well tolerated
Medical benefit
 Part of patients’
everyday life
November 2014
Efficacy
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Next developments milestones in BioChaperone insulins
Product
Event
Expected timeline
Results
Phase IIa on type 1 diabetics
Q1 15
Launch
Dose-response Phase IIa on type 1
diabetics
Q1 15
BioChaperone Lispro U100
Launch
Pump study, Phase IIa on type 1
diabetics
Q1 15
BioChaperone Lispro U200
Start
Phase I/II on type 1 diabetics
Q1 15
HinsBet
BC Combo
November 2014
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Product Breakthrough
1.
Insulin therapy
2.
Wound healing
3.
Oncology
November 2014
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Diabetic Foot Ulcer (DFU): a life-threatening disease
Diabetic Foot Ulcer
Neuropathy
& Ischemia
15% of
diabetic patients
will develop a
DFU
Chronic
hyperglycemia
60 %
Neuroischemic
patients in
Western countries
November 2014
1
Armstrong, D. G. et al Int Wound J 2007, 4 (4), 286-287
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Wound healing potential market
+
Severity of disease
Cellular therapies~ $10,000,
Complex management
Biologics~ $1,500
Only approved product for
DFU: Regranex® (PDGF-BB)
Dressings ~$200
November 2014
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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
November 2014
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BC PDGF-BB is non-inferior to Regranex
at a third the dosage, applied half as often
Phase I/II study in 200 diabetic patients in India
Incidence of complete wound closure after 20 weeks
79%
38/48
Once a day
Once every 2 days
Weekly dose
divided by 3
66%
31/47
November 2014
Property of ADOCIA
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
Western markets
cGMP PDGF
Emerging markets
WHO-GMP PDGF
November 2014
Neuroischemic
 EMA-validated shortened clinical
development plan
 Phase III launched Aug. 2014
(India)
Phase III results expected
Q1 16
60%
Next steps
Pre-IND meeting planned Q2 15
European Phase III Q4 15
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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
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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
Jean-Charles Kerihuel MD
MD
Sylvie Meaume MD, PhD
Stephan Morbach MD
David Armstrong
Akita Sadanori
DPM, PhD, MD
MD, PhD
Terry Treadwell
MD
November 2014
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Products breakthrough
1.
Insulin therapy
2.
Wound healing
3.
Oncology
November 2014
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ADOCIA in Oncology
Monoclonal Antibodies
Formulation
DriveIn®
 Improve mAb solubility
 Reduce viscosity in highly
concentrated solution
 Improve stability upon storage
2 ongoing partnerships with major
pharmaceutical companies
November 2014
 Targeted delivery for
chemotherapy
 Biomimetic hyaluronanbased Trojan horse
Phase 1 planned to start Q4 2015
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Financial Statements
November 2014
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2014 half year results: brief statement of accounts
30/06/2014
30/06/2013
Revenue
0,2
0,9
Other income
1,7
1,8
Total income
1,9
2,7
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%
In € thousands (IFRS rules)
November 2014
Property of ADOCIA
Variation
-30%
51
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)
November 2014
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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
November 2014
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ADOCIA – Next steps
November 2014
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ADOCIA – Next steps
Product / Technology
Therapeutic area
Event
Expected
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
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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
November 2014
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